Components for medical circuits

FIELD: medicine.

SUBSTANCE: invention relates to medical equipment. Components of expiratory limb include vapour-permeable materials, which are permeable for water vapour and, in fact, impermeable for liquid water and volume flow of gases. Limb channel from foamed polymer includes thermoplastic elastomeric material and cell voids, distributed inside solid material.

EFFECT: invention makes it possible to increase strength of limb wall with acceptable vapour-permeability.

24 cl, 4 tbl, 20 dwg

 

PRIORITY

According to this patent application for invention claims priority of the provisional application for U.S. patent No. 61/289,089, entitled "Components for Medical Circuits" and filed on December 22, 2009, the entire contents of which are incorporated herein by reference.

The LEVEL of TECHNOLOGY

The technical field to which the invention relates

The present statement refers, in a General sense, to components for medical circuits, and in particular to components for medical circuits supplying humidified gases to a patient and/or removing humidified gases from the patient, for example, when you create positive airway pressure (PAP), as in a respirator, anaesthesia, both in the fan and in the insufflation systems.

Description of the prior art

In medical use the various components of the transported gases having high levels of relative humidity, to patients and from patients. Condensation can be a problem when having high humidity gases come into interaction with the walls of the component at low temperature. However, condensation depends on many factors, including not only the temperature profile in the component, but also the gas flow rate, geometry of the component and its own ability to pass the vapor of the material used for the bulk� component, which represents the material's ability to transfer water vapor, thus, essentially, not transferring volumetric flow of liquid water and the volumetric flow of gas.

For example, in PAP-systems (ventilation systems that provide patients respiratory gas under positive pressure) breathing tube used for the delivery and removal of inhaled and exhaled gases. In this application, and other related breathing applications such as auxiliary breathing gases inhaled by the patient, usually delivered through a tube to breath at a humidity close to saturation. Respiratory gases exhaled by the patient through a breathing tube for the expiration and usually have full saturation. Condensation can form on the inner walls of a breathing circuit component within the patient breathing, and significant levels of condensation can form during exhalation of the patient. Such condensation is particularly harmful when it occurs in the vicinity of the patient. For example, the movable condensate formed in the respiratory tube (inspiratory or expiratory), can be inhaled by the patient or delivered in the process of breath, and can lead to a coughing fit, or other discomfort.

As another example, the insufflation system also deliver and remove moistened g�SHL. During laparoscopic surgery with insufflation may be desirable to insufficieny gas (usually CO2) moistened before passing through the abdominal cavity. This can help prevent "drying up" of the internal organs of the patient, and may reduce the duration of recovery after surgery. Even when using dry gas for insufflation, gas can become saturated absorbing their moisture from the body cavity of the patient. The moisture in the gases tend to condense on the walls of the outlet portion or tube insufflation system. Water vapor can also condense on other components of the system, insufflation, such as filters. Any steam, due to condensing moisture on the filter and the passage through the nozzles (inlet or outlet), is highly undesirable. For example, water that has condensed on the walls, can lead to saturation of the filter and its blocking. This can potentially lead to increased back pressure and prevents the implementation of smoke-removal system. In addition, liquid water in leads can flow to other connected equipment, which is undesirable.

Attempts were made to reduce the adverse effects of condensation by embedding in the walls of tubes strongly "parapolice�'s" materials, that is, materials that are highly permeable to water vapor and essentially impermeable to liquid water and the volumetric flow of gases. However, it required membranes with very thin walls for the purpose of achieving a permeability sufficiently high to prevent or reduce condensation. As a result, the tube having an acceptable permeability, had such thin walls that they required significant building measures. Such measures to strengthen increase the time, cost and complexity of the manufacturing process. Accordingly, there remains a need for a vapor-permeable, yet sturdy components for medical circuits for delivery of humidified gases.

Summary of the INVENTION

Herein, in various embodiments, provides details of materials and methods to create a vapour-permeable components for medical circuits, such as components for insufflation, anesthesia or respiratory circuits. These permeable components include permeable foamed material which is water vapor permeable and essentially impermeable to liquid water and the volumetric flow of gases. Set out the materials and methods can be integrated into a number of components, including tubes, Y-shaped connectors, fixtures, catheters and patient interfaces

Outlined medical component of a circuit for use with humidified gas. In at least one embodiment, the implementation component can include a wall defining an internal space, and wherein at least part of the said wall consists of a permeable foam material configured to prevent transmission of water vapor, but, essentially, to prevent the transmission of liquid water.

In various embodiments, the above component has one or several or all the following properties. The diffusion coefficient of vapor-permeable foam material should be at least 3×10-7cm2/C. the thickness of the wall may be in the range from 0.1 mm to 3.0 mm. vapor-Permeable foamed material may contain a mixture of polymers. Vapor-permeable foam material may include a thermoplastic elastomer with a polyether soft segment. Permeable foamed material may contain spoliatory thermoplastic elastomer with a polyether soft segment. Permeable foamed material may be sufficiently rigid so that the foamed material can be bent around a metal cylinder with a diameter of 25 mm without kinking or damage, in accordance with the test to improve the resistance of the p�current of bending according to ISO 5367:2000(E). The permeability P of the component in g-mm/m2/day should be at least 60 g-mm/m2/day when measured in accordance with ASTM E96 procedure A (using the method of drying at 23°C and a relative humidity of 90%). The modulus of elasticity of the component may be in the range of 30 to 1000 MPa. The permeability P can satisfy the formula:

P>exp{is 0.019(ln (M)]2A -0.7 ln(M)+6,5},

where M represents the modulus of elasticity of foamed polymer in MPa and M is in the range from 30 to 1000 MPa.

In addition, in various embodiments, the component on any or all of the previous implementation options has one, some or all of the following properties. The foamed material may contain voids. The foamed material may have a percentage of voids, greater than 25%. Foam can have an average size of voids in the transverse direction, less than 30% of the wall thickness. The foamed material may contain voids that are tapered along the longitudinal axis of the wall. At least 80% of voids can have a ratio of longitudinal length and a transverse height greater than 2:1. At least 10% voids may be connected to each other.

In some embodiments, the implementation component on any or all of the previous variants of implementation, may form in the presence of a wall� or the wall of the mask. If foamed material forms the wall of the tube, the tube can be, for example, extruded tube, corrugated tube or extruded corrugated tube. Any of the above mentioned tube may be a tube for use in insufflation system.

In at least one embodiment, the implementation component can include a wall defining a space, wherein at least a part of the wall consists of a foam material that is water vapor permeable and essentially impermeable to liquid water, the permeability P of the foam material, measured in accordance with ASTM E96 procedure A (using the method of drying at 23°C and a relative humidity of 90%) in g-mm/m2/day is at least 60 g-mm/m2/day and satisfies the following formula:

P>exp{is 0.019(ln (M)]2A -0.7 ln(M)+6,5},

where M represents the modulus of elasticity of the foam material in MPa and M is in the range from 30 to 1000 MPa.

In various embodiments, the above component has one, some or all of the following properties.Pmay be, at least 70 g-mm/m2/day.Mmay be in the range from 30 to 800 MPa. Wall thickness can be in the range from 0.1 mm to 3.0 mm. Foam m�material may have a percentage of voids, exceeding 25%. The foamed material may contain voids. Foam can have an average size of voids in the transverse direction, less than 30% of the wall thickness. At least some of the voids may be tapered along the longitudinal axis of the wall. At least 80% of voids can have a ratio of longitudinal length and a transverse height greater than 2:1. At least 10% voids may be connected to each other. Vapor-permeable foam material may include a thermoplastic elastomer with a polyether soft segment. Permeable foamed material may contain spoliatory thermoplastic elastomer with a polyether soft segment.

In some embodiments, the implementation component on any or all of the previous variants of implementation, may form the wall of the tube or the wall of the mask of the patient. If foamed material forms the wall of the tube, the tube can be, for example, extruded tube, corrugated tube or extruded corrugated tube. Any of the above mentioned tube may be a tube for use in insufflation system.

Also describes a method of manufacturing a component of a medical circuit. In at least one embodiment of the method includes mixing superconcentrate�and a foaming agent (a mixture of a polymer carrier and an active blowing agent with the polymer base material and forming a liquefied mixture, allows areas of a foaming agent to emit gas bubbles in the region of the base material liquefied mixture, and allow you to block the emission of gas bubbles and treating the mixture to form water vapor permeable component.

In various embodiments, the above method has one, some or all of the following properties. Can be selected blowing agent and/or polymeric base material, and the mixture may be processed for the purpose of forming a water vapor permeable component comprising solid polymer and voids distributed within the solid polymer. The permeability P of the component in g-mm/m2/day may be at least 60 g-mm/m2/day or at least 70 g-mm/m2/day, when measured in accordance with ASTM E96 procedure A (using the method of drying at 23°C and a relative humidity of 90%). The modulus of elasticity of the component may be in the range of 30 to 1000 MPa.Pcan satisfy the following formula:

P>exp{is 0.019(ln (M)]2A -0.7 ln(M)+6,5},

where M represents the modulus of elasticity of foamed polymer in MPa and M is in the range from 30 to 1000 MPa, or in the range from 30 to 800 MPa. Wall thickness can be in the range from 0.1 mm to 3.0 mm.

In addition, in various embodiments �of sushestvennee, a method according to any or all of the previous implementation options has one, some or all of the following properties. The foamed material may contain voids. The foamed material may have a percentage of voids, greater than 25%. Foam can have an average size of voids in the transverse direction, less than 30% of the wall thickness. The foamed material may contain voids that are tapered along the longitudinal axis of the wall. At least 80% of voids can have a ratio of longitudinal length and a transverse height greater than 2:1. At least 10% voids may be connected to each other. Vapor-permeable foam material may include a thermoplastic elastomer with a polyether soft segment. Permeable foamed material may contain spoliatory thermoplastic elastomer with a polyether soft segment.

In some embodiments, a method according to any or all of the previous variants of implementation may include the formation of a tube from a water vapor permeable component or forming a mask from a water vapor permeable component. If the method includes forming the tube from a water vapor permeable component, the processing activity of the mixture may include extruding the mixture in a tubular shape. R�ka mixture also may include joint extrusion of reinforcing ribs on the surface of pipe-shaped. The ribs may be located on the inner surface of the tubular form or on the outer surface of tubular shape, or the inner and outer surface of the tubular shape. In particular, the ribs may be located circumferentially around tubular shape, for example, may be located circumferentially around the inner surface of the tubular shape. Usually the ribs may be longitudinally tapered along the length of pipe shape. Treatment mixture also may include shirring extruded tubular shape. If the extruded tubular form homerooms, tubular form may contain ribs or they can be deleted.

Described tube for delivering humidified gas to the patient and from the patient. In at least one embodiment of the tube includes inlet and outlet ports, as well as extruded corrugated channel of foamed polymer, which is water vapor permeable and essentially impermeable to liquid water and the volumetric flow of gas, wherein the channel of foamed polymer is configured to ensure the flow of humidified gas from the inlet to the outlet within the space defined by the channel. The tube may further include a plurality of ribs. The ribs may be located at the inner�th surface of pipe-shaped or on the outer surface of tubular form, or the inner and outer surface of the tubular shape. In particular, the ribs may be located circumferentially around tubular shape, for example, may be located circumferentially around the inner surface of the tubular shape. Usually the ribs may be longitudinally aligned along the length of pipe between the inlet and the outlet.

In various embodiments, the above tube, described above with ribs or without them, have one, some or all of the following properties. Channel of foamed polymer may contain solid thermoplastic elastomeric material and cell voids distributed within the solid material. Channel of foamed polymer may have an inner surface adjacent to the confined space; and the internal volume adjacent to the inner surface, in which at least some of the cell voids are connected to other cell cavities, whereby there are formed open cell pathways, contributing to the movement of water vapor through the channel. At least 10% or at least 20% of the cell voids can be connected to other cell voids. The internal volume may be in the proportion of frequencies exceeding 25%. The average size of voids in the cross direction may be less than 30% of the wall thickness and�and less than 10% of the wall thickness. At least some of the voids may be tapered along the longitudinal axis of the channel. Flattening can be expressed as having an aspect ratio of longitudinal length to transverse the height gap of more than 2:1, or more than 3:1. At least 80% of the voids may be flattening.

In addition, in various embodiments, the tube on any or all of the previous implementation options has one, some or all of the following properties. Channel of foamed polymer may have a wall thickness from 0.1 mm to 3.0 mm. PermeabilityPcomponent measured in accordance with ASTM E96 procedure A (using the method of drying at 23°C and a relative humidity of 90%) in g-mm/m2/day may be at least 60 g-mm/m2/day. The modulus of elasticity of the component may be in the range of 30 to 1000 MPa. P can satisfy the formula

P>exp{is 0.019(ln (M)]2A -0.7 ln(M)+6,5},

where M represents the modulus of elasticity of the foam material in MPa and M is in the range from 30 to 1000 MPa. Channel of foam material may be sufficiently rigid so that the channel of foam material could be bent around a metal cylinder with a diameter of 25 mm without kinking or damage, in accordance with the test to improve the resistance to the flow of bending according to ISO 5367:2000(E.

In at least one embodiment of the tube includes inlet and outlet ports, and a channel from a foamed polymer, which is water vapor permeable and essentially impermeable to liquid water and the volumetric flow of gas, wherein the channel of foamed polymer allows flow of the humidified gas from the inlet to the outlet within the space defined by the channel and the channel of foamed polymer contains solid thermoplastic elastomeric material and cell voids distributed within the solid material. Channel of foamed polymer may have an inner surface adjacent to the confined space; and the internal volume adjacent to the inner surface. At least some of the cell voids of the inner volume can be connected to other cell cavities, whereby there are formed open cell pathways, contributing to the movement of water vapor through the channel.

In various embodiments, the above tubes have one, some or all of the following properties. Channel of foamed polymer may have a diffusion coefficient greater than 3×10-7cm2/s Channel can be extruded. The channel can be crimped. GWS�ka may further include a plurality of ribs. The ribs may be located on the inner surface of the tubular form or on the outer surface of tubular shape, or the inner and outer surface of the tubular shape. In particular, the ribs may be located circumferentially around tubular shape, for example, may be located circumferentially around the inner surface of the tubular shape. Usually the ribs may be longitudinally aligned along the length of pipe between the inlet and the outlet. The tube may include a heating wire. The heating wire may be longitudinally aligned along the length of the channel of foamed polymer between the inlet and the outlet.

In addition, in various embodiments, the tube on any or all of the previous implementation options has one, some or all of the following properties. At least 10% or at least 20% of the cell voids in the internal volume can be connected to other cell voids. The internal volume may be in the proportion of frequencies exceeding 25%. At least some of the voids may be tapered along the longitudinal axis of the channel. Flattening can be expressed as having an aspect ratio of longitudinal length to transverse the height gap of more than 2:1, or more than 3:1. At least 80% of cavities can and�et flattening. The average size of the voids in the internal volume in the transverse direction may be less than 30% or less 10% of the thickness of the duct wall of foamed polymer. Channel of foamed polymer may have a wall thickness from 0.1 mm to 3.0 mm. PermeabilityPtube, measured in accordance with ASTM E96 procedure A (using the method of drying at 23°C and a relative humidity of 90%) in g-mm/m2/day, may be at least 60 g-mm/m2/day. The modulus of elasticity of the tube may be in the range of 30 to 1000 MPa. P can satisfy the formula

P>exp{is 0.019(ln (M)]2A -0.7 ln(M)+6,5},

where M represents the modulus of elasticity of the foam material in MPa. Channel of foamed polymer may optionally have an outer shell that is contiguous with an internal volume in which the cell voids are closed cell. Shell thickness can be from 5 to 10% of the wall thickness, for example, from 10 to 50 microns.

Also the method of production of the tube, suitable for delivering humidified gas to the patient and from the patient. In at least one embodiment of the method includes mixing a foaming agent to the base material to form the extrudate, wherein the basic material contains one or more thermoplastic elastomers; the application of pressure to the extrudate using an extruder to form a hollow tube; the delivery of a hollow tube in the form of heropress; maintaining the hollow tube in the form of heropress to cool; and removing the cooled hollow tube from heropress, whereby is formed a corrugated permeable to water vapor pipe.

In various embodiments, the above method has one, some or all of the following properties. The tube may have a wall thickness from 0.1 mm to 3.0 mm. Corrugated tube may comprise a solid thermoplastic elastomer and voids formed by gas bubbles emitted by the blowing agent. The maximum size of the diameter of the voids in the cross direction may be less than one third of the minimum wall thickness. The percentage frequencies of the corrugated tube may comprise more than 25%. The core material may have a diffusion coefficient exceeding 0,75×10-7cm2/S. Core material may have a modulus of elasticity in tension greater than 15 MPa.

Also the method of delivering humidified gas to a patient or from the patient. In at least one embodiment of the method includes providing a medical component of a circuit that includes a wall formed by a vapor-permeable foam material, the connection of the medical component of the circuit to the patient and transfer the moist�x component of the medical gas through the circuit, this medical component of the circuit allows the passage of water vapor through the wall of the component, but, in essence, prevents the passage of liquid water and the volumetric flow of gas through the wall of the component.

In various embodiments, the above method has one, some or all of the following properties. The diffusion coefficient of vapor-permeable foam material may be at least 3×10-7cm2/C. the thickness of the wall may be in the range from 0.1 mm to 3.0 mm. vapor-Permeable foam material may include a thermoplastic elastomer with a polyether soft segment. In particular, vapor-permeable foamed material may contain spoliatory thermoplastic elastomer with a polyether soft segment. Permeable foamed material may be sufficiently rigid so that the foamed material can be bent around a metal cylinder with a diameter of 25 mm without kinking or damage, in accordance with the test to improve the resistance to the flow of bending according to ISO 5367:2000(E). PermeabilityPcomponent measured in accordance with ASTM E96 procedure A (using the method of drying at 23°C and a relative humidity of 90%) in g-mm/m2/day, may be at least 60 g-mm/m2/day. The modulus of elasticity whom�onent may be in the range of 30 to 1000 MPa. P can satisfy the formula

P>exp{is 0.019(ln (M)]2A -0.7 ln(M)+6,5},

where M represents the modulus of elasticity of the foam material in MPa and M is in the range from 30 to 1000 MPa.

In addition, in various embodiments, a method according to any or all of the previous implementation options has one, some or all of the following properties. The foamed material may contain voids. At least 10% voids may be connected to each other. The foamed material can have a share of frequencies exceeding 25%. Foam can have an average size of voids in the transverse direction of less than 30% of the wall thickness. At least some of the voids may be tapered along the longitudinal axis of the component. Flattening can be expressed as having an aspect ratio of longitudinal length to transverse the height gap of more than 2:1, or more than 3:1. At least 80% of the voids may be flattening.

In certain embodiments, the transfer of the wet gas through the medical component of a path can include the transfer of humidified gas through a tube containing vapor-permeable foamed material, or the transfer of humidified gas through a mask containing a vapor-permeable foamed material, or the transfer of humidified gas through the tube for in�afflalo, containing vapor-permeable foam material.

The invention includes all the above variants of implementation and also envisages constructions of the examples below.

BRIEF description of the DRAWINGS

Typical variants of implementation, which implement various features described systems and methods will be described below with reference to the drawings. The drawings and corresponding descriptions are presented to illustrate the embodiments and do not limit the scope of the presentation.

Fig. 1 is a schematic illustration of a medical circuit that includes a vapor-permeable components.

Fig. 2 is a graph in logarithmic scale on both axes of permeability depending on the young's modulus for several previously known vapor-permeable materials used in components for medical circuits; and Fig. 2B is a graph in logarithmic scale on both axes of permeability depending on the young's modulus for the previously known materials and vapor-permeable materials made of foamed plastics in accordance with the variants of implementation discussed in this document.

Fig. 3 is a graph of the relative diffusivity depending on the proportion of voids in permeable materials made of foamed plastics in accordance�accordance with the variants of implementation, discussed in this document.

Fig. 4A-4D are photomicrographs of typical foamed corrugated tube; Fig. 4E and 4F are photomicrographs another typical foamed corrugated tube; Fig. 4G and 4H are photomicrographs of typical foamed extruded tape; Fig. 4I and 4J represent another typical micrograph of the foamed extruded tape; Fig. 4K is a micrograph of expanded extruded tape formed from a mixture of polymers; Fig. 4L and 4M are photomicrographs of a foamed extruded tape formed from a mixture of polymers; and Fig. 4N and 4O are photomicrographs of expanded extruded tape.

Fig. 5 is a schematic illustration of a component for medical circuit that includes a vapor-permeable material made of foamed polymer.

Fig. 6A is a side view of pipe component comprising a vapor-permeable material made of foamed polymer; and Fig. 6B is a sectional view of pipe component with Fig. 6A.

Fig. 7A is a front view in perspective of a pipe component, which includes built-in stiffeners, wherein the component is partially crimped; Fig. 7B is a front view in perspective�e tubular component, which is fully crimped.

Fig. 8A is a photograph in front perspective of an alternative configuration of corrugated pipe component, which includes the ribs; Fig. 8B is a picture in front of it in the perspective of a tubular component of Fig. 8A; and Fig. 8C is a block of heropress suitable for forming a tubular component of Fig. 8A and 8B.

Fig. 9 is a schematic illustration of a vapor-permeable circuit in accordance with at least one of the variants of the implementation.

Fig. 10 is a schematic illustration of a component comprising a coaxial tube in accordance with at least one of the variants of the implementation.

Fig. 11A is a side view of the patient interface type mask according to at least one of the embodiments; and Fig. 11B is a front view in perspective of a patient interface of Fig. 11A.

Fig. 12 is a front view in perspective of a patient wearing the interface type "nasal hollow needle in accordance with at least one of the variants of the implementation.

Fig. 13 is a schematic illustration of the attachment of a catheter in accordance with at least one of the variants of the implementation.

Fig. 14 is a diagram�algebraic illustration of an insufflation system with humidification in accordance, at least one of the variants of implementation, which includes the input and output leads.

Fig. 15 is a schematic illustration of the method of production of a component according to at least one of the variants of the implementation.

Fig. 16A and 16B are photomicrographs showing the extruded foamed polymer having outer shell layer.

Fig. 17 is a flowchart showing a method of manufacturing a component according to at least one of the variants of the implementation.

Fig. 18 is a graph showing the perfect curve of sorption/desorption with a constant diffusivity.

Fig. 19 is a graph representative experimental desorption curves.

Fig. 20 is a graph of experimental desorption curve in comparison with the calculated desorption curve.

Throughout the drawings numerals are reused to indicate correspondence between the referent (or similar) elements. In addition, the first digit of each numerical designation indicates the figure in which the element appears for the first time.

DETAILED DESCRIPTION

In the following detailed description sets out new materials and methods for forming a permeable components for medical circuits, such as to�components for medical circuits for "permeable" insufflation, anesthesia or respiratory circuits. As explained above, these permeable components are water vapor permeable and essentially impermeable to liquid water and the volumetric flow of gases. Set out the materials and methods can be implemented in a variety of components, including the tubes (e.g., tubes for inhalation and exhalation and the other tubes between the various elements of the breathing circuit such as fans, humidifiers, filters, headers, line sampling, connectors, gas analyzers, etc.), Y-shaped connectors, fixtures, catheters and patient interfaces (e.g., masks to cover the nose and face, nasal masks, hollow needle, nasal pillows, etc.) in different medical paths. Medical footprint is a term with a broad meaning, and should be treated as having ordinary and customary meaning to a person skilled in the art (i.e., should not be limited to a special or specific value). Thus, it is assumed that the "health path" includes open contours, such as certain CPAP-systems, which may include a single tube to breath between the fan/blower and the patient interface, and a closed path.

Breathing circuit, which includes a vapor-permeable components

For the purposes of�of especiany a more complete understanding of presentation, first, refer to Fig. 1, which shows a breathing circuit in accordance with at least one of the variants of implementation, which includes one or more permeable components. This respiratory system can be a constant, a variable, or a two-tier system of creating positive airway pressure (PAP), or another form of respiratory therapy. In a typical breathing circuit, the patient 101 receives the humidified gas through a vapor-permeable tube 103 to breath. The tube is a term with a broad meaning, and should be treated as having ordinary and customary meaning to a person skilled in the art (i.e., should not be limited to a special or specific value), while it includes, without limitation, the non-cylindrical channels. Tube for inhalation is a tube that is configured to deliver the humidified respiratory gases to the patient. Permeable tubes are further discussed below.

Humidified gases can be transported to the circuit of Fig. 1 in the following way. Dry gases pass from the fan/blower to the humidifier 105 107 that moisturizes dry gases. The humidifier 107 is connected with the inlet opening 109 (end to receive humidified gases) tube 103 to breath through the port 111, whereby about�Westside supply humidified gases to the tube 103 to breath. The gases flow through the tube 103 to inhale to discharge port 113 (the end for the discharge of humidified gases), and then to the patient 101 via the interface 115 of a patient connected to the outlet 113. The tube 117 to exhale is also connected to the interface 115 of the patient. The exhalation tube is a tube that is configured for diverting exhaled humidified gases from the patient. In this case, the tube 117 to exhale returns exhaled humidified gases from the interface 115 of the patient to the fan/blower 105.

In this example, dry gases enter the fan/blower 105 through the opening 119. The fan 121 can improve the gas flow in the fan/blower by running air or other gases through the opening 119. The fan 121 may be, for example, a fan with variable speed, the controller 123 controls the fan speed. In particular, the operation of the electronic controller 123 can be controlled by the main electronic controller 125 in response to the input from the main controller 125 and configured by the user in advance via the dial 127 certain required value (preset value) of pressure or fan speed.

The humidifier 107 includes a chamber 129 of hydration, containing some 130 water or other� suitable moisturizing fluid. Preferably, the camera 129 of moisture can be removed from the humidifier 107 after use. The possibility of removal makes it easier to do sterilization or disposal chamber 129 of moisture. However, part of the humidifier 107, which is the chamber 129 of moisture, can be a standalone installation. The camera body 129 humidification can be made from non-conductive glass or plastic. But the camera 129 humidification may also contain conductive components. For example, the camera 129 of moisture may include a thermally conductive base (for example an aluminium base) that is in contact or associated with a heating plate 131 on the humidifier 107.

The humidifier 107 may also include electronic controls. In this example, the humidifier 107 includes an electronic, analog or digital main controller 125. Preferably, the main controller 125 is a microprocessor-based controller that executes commands software stored in associated memory. In response, for example, to enter a user-defined humidity or temperature using the dial 133, or through other means of input, the main controller 125 determines when (or to what level) to give energy to the heating plate 131 to heat the water inside the chamber 130 129 at�of lagania.

Can be connected to any suitable interface 115 of the patient. "Patient interface" is a term with a broad meaning, and should be treated as having ordinary and customary meaning to a person skilled in the art (i.e., should not be limited to a special or specific value), while it includes, without limitation, a mask (such as a face mask and nasal mask), hollow needle and nasal pillows. The patient interface usually defines the space that is in use gets warm humidified respiratory gases, and therefore is at risk of condensation. Due to the close proximity of the interface 115 patient to patient 101 that is highly undesirable. In order to solve the problem of condensation, the temperature sensor 135 may be connected to the tube 103 to breath near the interface 115 of the patient, or to the interface 115 of the patient. Temperature sensor 135 monitors the temperature near the interface 115 of the patient or in it. The heating wire (not shown) that communicate with a temperature sensor, can be used to set the temperature at the interface 115 and/or the tube 103 to breathe with the aim of raising the temperature in the tube 103 to breath and/or interface 115 of the patient above the saturation temperature. In addition to temperature�Pnom sensor and the heating wire (or alternatively), the interface 115 of the patient also may include "vapor permeable" interface described in more detail below in relation to Fig. 11A, 11B and 12.

Fig. 1 exhaled humidified gases are returned from the interface 115 of the patient to the fan/blower 105 through the tube 117 to exhale. The tube 117 to exhale preferably includes a vapor-permeable foam material, as described below. However, the tube 117 to exhalation may also be a medical tube, previously known in the art. In any case, the tube 117 to exhalation may have a temperature sensor and/or a heating wire, as described above in relation to the tube 103 for inhalation, which are integrated with it in order to reduce the risk of condensation forming. In addition, the tube 117 to exhale does not have to return the exhaled gases to the fan/blower 105. Alternatively, exhaled humidified gases can be passed directly into the environment or into other accessories such as air cleaner/air filter (not shown). In certain embodiments, the exhalation tube is not used.

Foamed polymers for the formation of permeable components

As explained above in relation to Fig. 1, medical circuits, such as breathing circuits, can be used "vapor permeable" components, such as tubes or interface�ISY patient. The ability to pass vapor is desirable to prevent condensation in these components. One of the characteristics of the ability to pass steam to the material is the permeability (expressed in g-mm/m2/day). Another feature is the ability to skip pairs is the diffusivity of water in the material (the diffusion coefficient, measured in cm2/C). Under similar test conditions, for example, at similar temperatures, permeability and diffusivity of a given material is directly proportional to each other. It is known that vapor-permeable materials made from thermoplastic elastomers (TPE according to ISO 18064:2003(E), which is hereby incorporated herein by reference in its entirety) are particularly suitable for the formation of such vapor-permeable components. However, these known materials are fragile and require significant strengthening in order for them to use.

It was found that the ability of the flowing steam to the strength can be unexpectedly improved by foamed polymer material, including previously known vapor-permeable polymers, if they are made of components. By implementing with a high ability to pass pairs of foamed materials can be produced components having relatively high stiffness in bending, and high ability to pass pairs. Similarly, the components formed of foam material described herein can also have a relatively high resistance to wrinkling and resistance to bending. As a result, it becomes possible to produce tubes with adequate three-dimensional characteristics (e.g., thickness, material, mixture of materials, modulus of elasticity, the ability to pass vapor and/or volumetric stiffness), corresponding to the requirements of the standard ISO 5367:2000(E) (namely, the test on the increase of resistance to flow) without amplification, they also have the enough ability to pass steam, in accordance with a more detailed description below. ISO 5367:2000(E) is hereby incorporated herein by reference in its entirety. For example, it was found that vapor-permeable materials made from thermoplastic elastomer (TPE), such as ARNITEL® VT 3108, are particularly suitable for foaming and forming components in accordance with various embodiments of the implementation. For this material the ability to pass steam to the durability can be greatly improved through the foaming material in the production of its product or component.

Thus, certain embodiments of include ISP�Lituanie, what specific foam materials can be used to form a permeable component, wherein the components and have the young's modulus (stiffness), and permeability (ability to pass pairs), which are significantly improved compared to previously known vapor-permeable materials. Such foamed polymers and methods for forming foamed polymers, as well as components for medical circuits containing such foamed polymers described herein as illustrative examples. Because of their high permeability, these foamed polymers allow water vapour to quickly diffuse through them. This reduces the accumulation of condensation inside the component through the transfer of water vapor from the humidified gases within the component to the surrounding atmosphere or other dry gases on the other side of the component. In addition, the components formed from such foams are rigid, self-sustaining, resistant to wrinkling, or semi-rigid, and may even not require additional amplification. Foamed polymers are also suitable for forming the components, because the foamed polymer allows it to transfer water vapor from gases, but prevents the transmission of liquid water. They are also, in essence, NEP�nizaami for the volumetric flow of gas, consequently, they can be used to form components for delivery of humidified gases.

Typically, the foamed polymer in accordance at least with one variant of implementation, is a vapor-permeable foamed thermoplastic polymer. Preferably, vapor permeable thermoplastic polymer is a foamed thermoplastic elastomer (or TPE as defined in ISO 18064:2003(E)), such as (1) spoliatory thermoplastic elastomer (for example, ARNITEL®, representing spoliatory thermoplastic elastomer with a polyether soft segment, or other TPC or TPC-ET materials, in accordance with defined in ISO 18064:2003(E)), or (2) a polyester amide units (for example, PEBAX®, which is a polyamide thermoplastic elastomer with a polyether soft segment, or other materials TPA-ET, in accordance with defined in ISO 18064:2003(E)), or (3) thermoplastic polyurethane (TPU material, in accordance with defined in ISO 18064:2003(E)), or (4) a mixture of foamed polymers, such as a mixture of TPE/polybutylene terephthalate (PBT, for example, DURANEX® 500FP). If vapor permeable thermoplastic polymer mixture is foamed TPE/PBT, the mixture preferably comprises from 80% to 99% (or from about 80% to about 99%) TPE by weight and from 20% to 1% (or from about 20% to about 1%) PBT by weight.

In any of �abovementioned embodiments, the proportion of voids in the foamed material may constitute more than 25% (or about 25%), for example, between 25 and 60% (or from about 25 to about 60%), between 30 and 50% (or from about 30 to about 50%). In at least one embodiment of the implementation, not more than 5% (or about 5%) voids specified foam material have a diameter exceeding 500 μm.

Fig. 2A shows a graph in logarithmic scale on both axes of the permeability values depending on the young's modulus presented in the literature for the vapor-permeable materials previously known in the art. Values change by six orders of magnitude as for the modulus, and permeability.

Fig. 2B adds to Fig. 2A the data points for typical examples of foamed polymers in various embodiments of the implementation described in this document, marked from #1 to #4 and #6. It was found that the combined values of the permeability and modulus for all previously known materials do not exceed direct 201, represents a formula:

ln(P)=is 0.019(ln(M))2A -0.7 ln(M)+6,5

in which P represents the permeability of the material in g-mm/m2/day as measured in accordance with ASTM E96 procedure A (method of drying at 23°C and a relative humidity of 90%), and M represents the young's modulus of the material in MPa. ASTM E96 is hereby incorporated in its entirety in this document by reference.

�La foamed polymeric materials, represented by points #1-#4, #6 and #8 in Fig. 2B, the permeability P satisfies the formula

P>exp{is 0.019(ln (M)]2A -0.7 ln(M)+6,5}

Thus, these foamed polymers have combined levels of the ability to skip pairs and stiffness, not previously known.

The permeability and modulus of foamed polymer can be selected to provide increased stiffness and/or disruption of the pairs of components that includes a foamed polymer. Preferably, the material must be sufficiently rigid to ensure that it was not easy to crush or twist, or change its volume under pressure. For example, vapor-permeable foamed polymer must be sufficiently rigid so that the foamed polymer could be bent around a metal cylinder with a diameter of 25 mm without kinking or damage, in accordance with the test to improve the resistance to the flow of bending according to ISO 5367:2000(E). Therefore, the module exceeds 30 MPa (or about 30 MPa) in at least one embodiment of the implementation. The line M=30 MPa is shown in Fig. 2B as a direct 203. However, it also may be desirable to limit the stiffness of the component in order to improve the ease of handling of the component or improve patient comfort. Therefore, the module M may be restricted in certain embodiments, a value of less than 1000 MPa (or about 1000 MPa). PR�may M=1000 MPa 205 is shown as a straight. Also may be desirable to limit the module M to a value of less than 800 MPa (or about 800 MPa), or less than 500 MPa (or about me).

In addition, it may be desirable to select the ability to skip the steam is high enough to prevent condensation in a number of practical applications and medical components. It was found that the foamed polymer diffusivity is a function of the fraction of void volume. This is illustrated in table 1, which shows for each value of relative humidity (RH) the ratio of diffusively when a specific percentage of voids (D) to diffusively, at the same RH, solid ARNITEL® VT 3108 (D0). The graph for the data from table 1 shown in Fig. 3.

Table 1
The value of the relative diffusivity D/D0
Point numberName of templateThe proportion of voidsRH=100RH=97RH=92RH=84RH=75RH=69
FmdAd10,1681,181,09 1,191,17
1AB-14,20,3372,25At 2.262,27
2MB 27 4%0,412,612,682,732,643,21
3FIIA-20,466To 4.284,113,452,95
4FIIA-50,536,607,137,79
4FIIA-50,537,085,0
7FIIA-101,001,001,001,001,001,00
Batch
15 wts
0,56Of 7.19
Batch
15 wts
0,567,446,836,366,98
Batch
15 f
0,554,97Levels lower than the 5.37Of 6.025,996,06
MB 27 6%0,52 5,605,195,526,176,95
MB 41,40,462Of 3.913,593,744,06
MB to 22.10,241The 1.651,661,56

Accordingly, it is possible to choose an appropriate level of permeability and/or the percentage of voids for foamed polymer for the purpose set corresponding disruption of the pairs. In certain embodiments, the permeability P is more than 60 g-mm/m2/day (or about 60 g-mm/m2/day) when measured in accordance with procedure A of ASTM E96. The permeability of 60 g-mm/m2/day corresponds to a 66% increase compared to solid ARNITEL® VT 3108. The line P=60 g-mm/m2/day 207 is shown as a straight. In some embodiments, may also be desirable that the selected permeability P prevyshala MPa g-mm/m 2/day (or about 70 g-mm/m2/day).

You can associate the permeability of the corresponding percentage of voids. The permeability of 60 g-mm/m2/day 1.66 exceeds the value for solid ARNITEL® VT 3108. Since it is known that the permeability is directly proportional to diffusivity, you can find the appropriate proportion of the voids in which the ratio of diffusivity will be more of 1.66, Fig. 3. According to Fig. 3, the corresponding proportion of voids greater than 25%. Accordingly, in certain embodiments, the percentage of voids greater than 25% (or about 25%). Also, in some embodiments, may be desirable to select the percentage of voids, greater than 30% (or about 30%). The proportion of voids in 30% corresponds to a permeability of 70 g-mm/m2/day (or about 70 g-mm/m2/day), as explained above.

Also may be desirable to limit the proportion of voids in the foamed polymer to prevent the flow of liquid water through the voids. If the foamed polymer does not contain the structure of the outer shell (discussed more below), it may be desirable that he had a share of voids less than 45% (or about 45%). If the foamed polymer has a structure of the outer shell, it may be appropriate fraction of voids, the lower 60% (or about 60%). It was found that the proportion of voids between 25 and 60% (or from about 25 to about 60%) for foamed ARNITEL® VT 3108 is� appropriate for the formation of components for medical circuits, as described in this document. For example, the percentage of voids in 30% (or so) can improve the ability to pass pairs of Arnitel VT3108 up to 2 times. A relatively small reduction module can be compensated by adding the thickness of the component, as described below, while maintaining a similar disruption of the pairs. It was found that the proportion of voids between 30 or 50% (or from about 30 to about 50%) foamed ARNITEL® VT 3108 especially well suited for the formation of these components. It should be understood that the above values are examples only appropriate percentage of voids and the corresponding properties of materials.

As discussed above, another measure of the ability to skip material is vapor diffusivity of water in the material (the diffusion coefficient, measured in cm2/C). Under similar test conditions, the permeability and diffusivity is directly proportional to each other for a specific base material. In various embodiments, the foamed polymer has a diffusion coefficient greater than 3×10-7cm2/s (or so), and, preferably, greater than 6×10-7cm2/s (or so). For example, it was calculated that a rod with a diameter 0,1625 cm of foamed ARNITEL® VT 3108, with 47% percentage of voids has a diffusion coefficient equal to (or approximately�about equal) to 7.6×10 -7cm2/C. as another example, it was calculated that the film thickness of 0,0505 cm of foamed ARNITEL® VT 3108, with 13% percentage of voids has a diffusion coefficient equal to (or approximately equal) to 3.3×10-7cm2/S.

Samples #1-#4 in Fig. 2B contain foamed ARNITEL® VT 3108. It can be seen that these materials, and in particular the sample #4 with a 53% share of the voids exhibit better characteristics than any other previously known material with regard to their combined values of permeability and module. For sample #4, the foaming process resulting in an average increase of permeability of approximately 6.5 times at 97% RH, the value of the module is maintained at 30% of net ARNITEL® VT 3108.

Fig. 2B point #1 represents the data for the sample named "AB 14.2 a". AB 14.2 a is a tube for adults, with an outside diameter of 24.5 cm, from corrugated foamed ARNITEL® VT 3108. Experimental data collected on this sample include micrograph (shown in Fig. 4A-4D and are summarized in table 2), percentage of voids and the average thickness of the sample (shown in table 3), modulus (shown in table 4) and the change in diffusivity depending on RH (summarized in table 1).

Point #2 represents data for a sample named "MB27 4%". MB27 4% is a tube for children, with an external diameter to 15.46 cm, foamed corrugated ARITEL® VT 3108. The tube was extruded from a mixture of basic polymer (ARNITEL® VT 3108) and 4% (or about 4%) by weight superconcentrate blowing agent (containing polyethylene and 20% by weight Clariant HYDROCEROL® BIH-10E). Experimental data collected for this sample include micrograph (shown in Fig. 4E and 4F are summarized in table 2), percentage of voids and the average thickness of the sample (shown in table 3), modulus (shown in table 4) and the change in diffusivity depending on RH (summarized in table 1).

Point #3 represents the data for the sample named "FIIA-2". FIIA-2 is an extruded strip of foamed ARNITEL® VT 3108. Experimental data collected for this sample include micrograph (shown in Fig. 4G and 4H are summarized in table 2), percentage of voids and the average thickness of the sample (shown in table 3), modulus (shown in table 4) and the change in diffusivity depending on RH (summarized in table 1). Also measured the change in size depending on the water content. It was determined that the change in length depending on the water content can be described by the following formula:

where

W% - the number of grams of water absorbed per gram of dry polymer

X - the measured size, and

X0- the measured size when W%=0.

Point #4 is the data for the sample named"FIIA-5". FIIA-5 is an extruded strip of foamed ARNITEL® VT 3108. Experimental data collected for this sample include micrograph (shown in Fig. 4I and 4J are summarized in table 2), percentage of voids and the average thickness of the sample (shown in table 3), modulus (shown in table 4) and the change in diffusivity depending on RH (summarized in table 1). Also measured the change in size depending on the water content. It was determined that the change in length depending on the water content (Δ X/X0) can be described by the following formula:

Point #5 represents data for a sample called "80/20 ARNITEL/PBT". 80/20 ARNITEL/PBT is an extruded tape of a polymer made from a mixture of 80/20 by weight percent ARNITEL® VT 3108 and polybutylene terephthalate (PBT). Experimental data collected for this sample include micrograph (shown in Fig. 4K and summarized in table 2), the average thickness of the sample (shown in table 3), modulus (shown in table 4) and diffusivity at RH=100 (summarized in table 1).

Point #6 represents data for a sample named "foam 80/20 ARNITEL/PBT". Foam 80/20 ARNITEL/PBT is a foamed extruded ribbon of polymer made from a mixture of 80/20 by weight percent ARNITEL® VT 3108 and PBT. Experimental data, collected�s for this sample, include micrograph (shown in Fig. 4L and 4M and are summarized in table 2), percentage of voids and the average thickness of the sample (shown in table 3), modulus (shown in table 4) and diffusivity at RH=100 (summarized in table 1).

Point #7 presents data for the sample named "FIIA-1". FIIA-1 is an extruded strip of solid Arnitel 3108. Experimental data collected for this sample include micrograph (shown in Fig. 4N and 4O are summarized in table 2), the average thickness of the sample (shown in table 3), modulus (shown in table 4) and the change in diffusivity depending on RH (summarized in table 1). Also measured the change in size depending on the water content. In accordance with observations, the change in all three dimensions (length, width and thickness) were almost identical (i.e., the observed isotropic expansion), and this change could be described by the following formula:

This ratio was used to calculate the thickness change of the sample over time in experiments on the desorption of water.

Finally, point #8 represents data for a sample named "TPU/Acetal fmd 10%". TPU-acetal fmd 10% is an extruded strip of foamed mixture ESTANE® 58245 (TPU) and acetal. Experimental data collected for this sample include� in the proportion of voids and the average thickness of the sample (shown in table 3), module (shown in table 4) and diffusivity (shown in table 4).

Also in Fig. 2B illustrates the point designated as "FmdAd1". FmdAd1 is a tube for adults from corrugated foamed ARNITEL® VT 3108, with an outside diameter of 24.5 cm. the Experimental data collected for this sample, include the proportion of voids and the average thickness of the sample (shown in table 3), modulus (shown in table 4) and the change in diffusivity depending on RH (summarized in table 1).

Additional materials of expanded and foamed polymers, which are not shown in the graph of Fig. 2A or 2B, described below.

"Batch 15 wts", "Batch 15f", "MB27 0%", "MB27 6%", "MB22.1", "MB32.1", "MB41.4" is a corrugated tube for children, with an external diameter to 15.46 cm, foamed ARNITEL® VT 3108. Experimental data collected for these samples include the proportion of voids and the average thickness of the sample (shown in table 3) and the change in diffusivity depending on RH (summarized in table 1). For MB32.1 was also measured the change in length depending on the water content. It was found that the change described by the formula:

"TPU, ESTANE 58245" is a tube of corrugated expanded TPU (ESTANE® 58245), having a thickness 0,048 see Experimental data collected for these samples include the proportion of voids and environments�Yuyu thickness of the sample (shown in table 3), module (shown in table 4) and diffusivity (shown in table 4).

Table 2
Synthesis of microphotographs
Point numberThe sample nameIncreaseComment
1AB 14.2 a10×(FIG. 4A, C) 20×(FIG. 4B, D),Many of the cells flattened, somewhat connected
2MB27 4%10×(FIG. 4E)
20×(FIG. 4F)
All the cells are much flattened, many connected
3FIIA-220×(FIG. 4G)
30×(FIG. 4H)
Highly flattened cells, many connected
4FIIA-520×(FIG. 41)
30×(FIG. 4J)
Highly flattened cells, many connected
580/20 ARNITEL/PBT20×(FIG. 4K)Cells were observed
6 foam 80/20 ARNITEL/PBT15×(FIG. 4L)
20×(FIG. 4M)
Cells spherical and isolated from each other
7FELA-120×(FIG. 4N)
30×(FIG. 40)
Cells were observed

Photomicrographs show that the samples of foamed polymers (samples #1-#4 and #6) contain the cells or voids within the solid polymer. It is desirable that the size of the data voids in the transverse direction was less than 30% (or about 30%) the thickness of foamed polymer, for example, less than 10% (or about 10%) of the total thickness.

The micrographs also show that for certain samples of foamed polymers placed above the direct 201 and 207 (P>60 g-mm/m2/day) Fig. 2B (i.e., samples #1-#4), voids, essentially, are tapered and not spherical. Tapered shape of the voids, in turn, causes the flattening of the polymer between the voids. It was found that the tapered shape of the polymer improves the mechanical properties of components containing foamed polymer. It is believed that large continuous length of polymer in the longitudinal direction increases the modulus in this direction. Therefore, at least one of the embodiments includes the use, �for the foamed polymer may be a beneficial presence, at least a certain number of voids, such as at least 80% or so, which is tapered along the longitudinal axis. The aspect ratio of such flattening (length to height), preferably, is at least 2:1 (or about 2:1) or at least 3:1 or about 3:1, e.g. between 2:1 and 7:1, or from about 2:1 to about 7:1 or between 3:1 and 7:1, or from about 3:1 to about 7:1).

Also in these samples was observed that voids are not isolated from each other. Many voids are connected or United with each other. That is, the foamed polymer has "open cells". The open cell structure of foamed polymer improves the ability to skip pairs, since it allows water vapour to pass a greater distance in the axial (or transverse), and in the longitudinal direction, thus it should not pass through the solid polymer. Preferably, at least 10% (or about 10%) of voids in the foamed polymer are connected to each other. In some embodiments, at least 20% (or 20%) of voids interconnected with other voids.

Table 3
Summary data for the fractions of voids and average thickness
Point numberThe sample name The proportion of voids, %The average thickness, cm
FmdAdl16,80,507
1AB 14,2 a33,70,0487
2MB27 4%41,00,0628
3FIIA-246,60,173
4FIIA-553,00,198
580/20 ARNITEL/PBT0,00,1807
6Foam 80/20 ARNITEL/PBT20,00,1647
7FIIA-10,00,124
8Foamed TPU/Acetal 10%15,0-20,00,139
TPU, ESTANE 58245 0,00,048
Batch 15 wts56,00,0799
Batch 15 f56,00,0799
MB27 0%0,00,0256
MB27 6%52,00,0941
MB22,124,1It is 0.0575
MB32,133,20,0448
MB41,446,20,0829

Table 4
Summary data for the module, diffusivity and permeability
Point numberThe sample nameModulus, MPaDiffusivity at RH=97, cm2/sPermeable�St', g-mm/m2/day
ARNITEL® VT 31081222,11×10-736
FmdAdl96,82,30×10-739
1AB 14,261,5To 4.77×10-781,4
2MB 27 4%455,65×10-796,5
3FIIA-247,78.66 roubles×10-7Was 147.6
4FIIA-541,713,7×10-7234
580/20 ARNITEL/PBT3751,46×10-724,8
6Foam 80/20 ARNITEL/PBT2661,9�10 -732,5
7FIIA-11222,11×10-736
8Foamed TPU/Acetal 10%376,59×10-6151
TPU, ESTANE 58245182,41×10-780

In the table the data on permeability for containing ARNITEL® samples were calculated using the relationship:

where Psamplerepresents the permeability of the sample, PARNITELVT3108represents the permeability of ARNITEL® VT 3108, Dsamplerepresents the diffusivity of the sample and DARNITELVT3108represents the diffusivity ARNITEL® VT 3108. Similarly, permeability data for containing TPU (ESTANE®) samples were calculated using the relationship:

PESTANE584253and DESTANE584253represent the permeability and diffusivity ESTANE® 58245, respectively. Multiplier of 0.7 reflects the lower water content in the mixed sample.

Another suitable material from span�x polymer is a polyester thermoplastic polyurethane (TPU), which has a good ability to pass vapor and tear resistance. However, the TPU has a poor rigidity (low modulus). There have been many studies to improve the rigidity of the material by blending with other polymers. However, it was discovered that though the TPU mixing with other polymers can be effective from the point of view of increasing stiffness, may be a strong reduction of the disruption of the vapor of the mixed polymer.

After testing the mixture were identified, which greatly increase the mechanical rigidity without compromising the ability to skip pairs to an unacceptable level. An example of a mixture is the mixture of sobolifera TPE/PBT discussed above. Another example of the mixture includes TPU and polycarbonate-Acrylonitrile butadiene styrene (PC-ABS sold, for example, as WONDERLOY®). A suitable ratio of weights TPU:WONDERLOY® is 70:30 70:30). Tests conducted using having a diameter of 19 mm single-screw extruder, showed that the tensile strength of the mixture shows a noticeable improvement in stiffness compared to a single TPU (in 14 times or so), whereas the rate of transmission of water vapor shows only a slight decrease in the ability to skip pairs (30% or so). By foaming the mixture of polymers TPU-WONDERLOY® can �be achieved further improvement in their ability to pass pairs in comparison with the rigidity as discussed above.

As discussed above, another example of a mixture according to at least one of the embodiments, includes TPU (ESTANE® 58245) and acetal, a compound having a very low ability to pass a vapor permeability and water absorption. Foam tape (the proportion of voids between 15 and 20%, or about 15 and 20%) was made from ESTANE® 58245 and acetal in a weight ratio of 70:30 70:30). The average thickness of a sample was 0,139 see the water Uptake of the blend at 100% RH was 0.38 g of water per gram of dry polymer (38%). Diffusivity of the sample was measured on the desorption curve and amounted 6,59×10-6cm2/s at 23°C. the Modulus of the sample was 34 MPa, and the calculated value of permeability was 151 g-mm/m2/day.

These results are compared with the control sample, which comprises expanded TPU (ESTANE® 58245). Was extruded corrugated tubing having a wall thickness 0,048 cm and water absorption at 100% RH, which is 0.53 g of water per gram of dry polymer (53%). The non diffusivity of the sample was measured on the desorption curve, and was 2.41×l0-7cm2/s at 23°C. the Module was 18 MPa. Permeability of this polymer is 80 g-mm/m2/day.

Components containing foamed polymers

It should be understood that vapor-permeable foamed material�s, as described above, can be used in many medical components, which is useful material that has a high ability to pass vapor, but which is self-supporting and semi-rigid. Accordingly, all the features of the vapor-permeable foam materials discussed above that are applicable to these components. Below are just some examples of components that vapor-permeable foamed material provides new advantages that were previously impossible. Manipulation of fractions of voids, thickness and size of the voids allow for the adjustment of the volumetric properties of the formed components in a wide range.

Typically, the component includes a wall that defines the interior space, and wherein at least part of the said wall comprises a vapor-permeable foam material, as discussed above, allowing you to be the transfer of water vapor from gases within the space, but prevents the transmission of liquid water. Preferably, the wall is impermeable to the volumetric flow of gases within the space, including respiratory gases, anesthesia, insufflate gases and/or smoke.

Because of its ability to pass vapor wall forms a trajectory of movement of water vapor from space with gases to region�STI on the other side of the wall. In some embodiments, there is a trajectory of movement of water vapor from space with gas to surrounding air through said vapor-permeable foam material. The trajectory through the wall may be straight, and the wall may be in direct contact with the surrounding air. Alternatively, the trajectory may be indirect, and the trajectory may pass through one or more other walls of the space between the gas and the surrounding air. In other configurations may be present the second space with gases (called space displaced gases) on the other side of the wall, instead of ambient air. Displaced gases can, in turn, indirectly, be released into the surrounding air. In this case the trajectory of the water vapor passes from the space with gases to the space displaced by gas.

In any of the above embodiments, all of the bounding wall as a whole may be formed from foam material. In at least one embodiment, the implementation of at least the region of the wall may have a thickness between 0.1 and 3.0 mm (or from about 0.1 to about 3.0 mm), for example, between 0.1 and 1.5 mm (or from about 0.1 to about 1.5 mm). For example, the area of the wall may have a thickness of at least between 0.7 and 1.0 mm (or from about 0.7 to about 1.0 mm) or �between 0.7 and 3.0 mm (or from about 0.7 to about 3.0 mm).

In any of the above embodiments, the wall may include at least two zones. The first zone represents the outer shell comprising a layer of, essentially, a foamed material with closed cells, and the second zone consists of an inner layer adjacent to the outer layer, and located between the outer layer and the space with gases. Shell thickness can range from 5% to 10% (or from about 5 to about 10%) of the wall thickness, for example, from 10 to 50 μm (or from about 10 to about 50 microns). The first and the second zone are empty. In certain embodiments, no more than 5% (or about 5%) of voids in the first zone have a diameter greater than 100 microns. The voids in the second zone is greater than the voids in the first zone. For example, in some embodiments, not more than 5% (or about 5%) voids specified second zone foam material have a diameter greater than 700 microns.

In any of the above embodiments, the wall may include at least one stiffener that increases the rigidity of the wall or at least one area in which the wall is locally thickened to increase the stiffness of the wall.

A component can represent a patient interface; or tube, such as a breathing tube, for use in the breathing loop; or the tube and at least a portion of the patient interface; or channel (i.e., the portion of the tube which does not have to be closed on its circumference) for use in the breathing loop; or the mask (including the frame and the gasket located around the perimeter of the frame of the mask, wherein the mask frame includes a wall, and a large part of a wall formed from a permeable foam material); or system component insufflation, such as a tube or channel to use, at least part of the expiratory tube insufflation system.

Below, reference is made to Fig. 5, which shows the component 501 in accordance at least with one variant of implementation. Formed component 501 has a wall 503 that defines the space 505 gases on one side. Wall 503 includes a vapor-permeable foamed polymer as described above. As shown by the dotted line 507, a wall can both ask and not ask a completely closed space 505 with gases. In the process of using the space with gases may be essentially closed, the wall 503 defines the space 505 gases on one side wall 503, and the space 505 contains wet gas.

On the other side of the wall 503 is the second space 509 with gases. In at least one embodiment of the implementation, the second question�ransta 509 gases represents the surrounding air. Wall 503 of the component 501 is made of vapor-permeable foam material that allows the transfer of water vapor, but, in essence, prevents the transmission of liquid water and the volumetric flow of respiratory gases. To permeable foamed material is allowed to dry gases in the space 505, the outer surface of the wall 503 interacts with the surrounding air or dry the water displaced by the gas in the second space 509 with gases. In this configuration, the gases having a high relative humidity within the space 505, can be dried by passing water vapor through the wall 503 to the second space 509 gases, which can represent, for example, ambient air. Dehumidification of gases within the space 505 with gases it is advisable to create and/or prevent condensation in the space 505 gas when filled with relatively warm or moist gas/air/breathing gas.

In one example, the component 501 may represent a patient interface, such as a respiratory mask, and the space 505 gases can be at least partially defined by a wall 503, and the face of the patient (not shown) may, in substance, to contain a space 505. In this example, the face of the patient represented with a dotted line 507. In another embodiment of the implementation, to�mponent 501 may be a breathing tube (inspiratory or expiratory). The interfaces of the patient and the breathing tubes are further discussed below.

Permeable tube

When respiratory support, in particular, in medical applications, gases having high levels of relative humidity, are submitted and returned through the flexible respiratory tube of relatively limited size, typically in the range of diameters from 10 to 25 mm, or from about 10 to about 25 mm) (covers use for babies and adults). These breathing tubes, in the ideal case, very light, resistant to bending or compression, and are flexible to ensure the best performance and comfort for the patient. Lightweight breathing tube is very important for reducing any forces exerted by the weight of tube to the patient interface. Similarly, the breathing tube must be flexible and have the ability to easily be bent to achieve a high level of patient comfort, which, in turn, can improve patient compliance with treatment regimen. However, excessive light and flexible components are usually weak and prone to excessive bending. It was found that the tube containing the above described foamed polymer that can resist bending or compression, and is lightweight and flexible enough to improve patient comfort.

Since the tube is a type of component�and, it features component, discussed above, is applicable to the tube discussed here. Typically, the medical tube circuit includes an inlet opening (to receive humidified gases), an outlet (for the emission of humidified gases) and a bounding wall defining at least one channel for passage of gases between said inlet and the outlet, wherein at least part of the said bounding wall is made of vapor-permeable foam material that permits transmission of water vapor, but essentially prevent the transmission of liquid water and the volumetric flow of respiratory gases. In at least one embodiment of the tube is an extruded corrugated pipe. The medical tube of the circuit can be used as a breathing tube or channel, or as a tube or channel for the pipe system insufflation. For example, the tube may be a breathing tube for exhalation or exhaust channel, respectively. The tube can also be part of the patient interface.

The tube may be flexible. That is, the tube can be bent around a metal cylinder with a diameter of 25 mm without kinking or damage. More specifically, the tube is flexible in accordance with a defined by PR�walking test to improve the resistance to the flow of bending according to ISO 5367:2000(E).

In any of the above embodiments, the tube may have a length of from 1 to 2 m (or from about 1 to about 2 m), for example 1.5 m (or 1.5 m). The tube may have an average diameter of from 10 to 25 mm, or from about 10 to about 25 mm). In at least one embodiment of the implementation, the tube has a wall thickness of from 0.1 to 1.2 mm (or from about 0.1 to about 1.2 mm, e.g., about 0.6 mm to 1.0 mm (or from about 0.6 to about 1.0 mm). Preferably, the tube includes a "permeable" limiting wall at a considerable part of its total length. For example, in at least one embodiment, the implementation of at least 80% of the length of the tube includes a vapor-permeable bounding wall. Permeable wall is preferably located near the inlet of the tube for receiving the humidified gas. For example, for a tube length of 1.5 m (or 1.5 m) of at least 1.2 m (approximately 1.2 m) tube includes a vapor permeable wall, starting near the inlet.

Because of its ability to pass vapor wall forms a trajectory of movement of water vapor from space with gases to the field on the other side of the wall. In some embodiments, there is a trajectory of movement of water vapor from space with gas to surrounding air through said vapor-permeable foam material. Trajectory d�izheniya through the wall may be straight, and the wall can be in direct contact with the surrounding air. For example, in at least one embodiment of implementation, the snorkel is a breathing tube and has at the ends of the first connector in the specified input hole and the second connector to the specified output hole. Provided only one trajectory of gases over a length between said input connector and the output connector.

Alternatively, the trajectory may be indirect, and the trajectory may pass through one or more other walls of the space between the gas and the surrounding air. In other configurations may be present the second space with gases (called space displaced gases) on the other side of the wall, instead of ambient air. These displaced gases can, in turn, indirectly, be released into the surrounding air. In this case the trajectory of the water vapor passes from the space with gases to the space displaced gases. For example, the tube may be a coaxial breathing tube. In a coaxial breathing tube space with gases is the nozzle of the inhalation or the exhalation pipe, and a second space with gases is another jet from the nozzle of the inhalation and exhalation pipe. One path of the gases is presented between I�Western hole specified inspiratory tube and the outlet of the specified pipe of breath, and one path of the gases is presented between the inlet of the specified port of the exhalation and the outlet of the specified port of the exhalation. In one embodiment, the implementation space with gases is the specified pipe of breath, and the specified second space with gas is the outlet of the exhalation. Alternatively, space with gas may be the outlet of the exhalation, and the second space with gases may be a pipe of breath.

As discussed above in the description of the component in any of the above embodiments, the wall may include at least two zones. The first zone represents the outer shell comprising a layer of, essentially, a foamed material with closed cells, and the second zone consists of an inner layer adjacent to the outer layer and located between the outer layer and the space with gases. Shell thickness can range from 5% to 10% (or from about 5 to about 10%) of the wall thickness, for example, from 10 to 50 μm (or from about 10 to about 50 microns). The first and the second zone are empty. In certain embodiments, no more than 5% (or about 5%) of voids in the first zone have a diameter greater than 100 microns. The voids in the second zone is greater than the voids in the first zone. For example, in some embodiments, not more than 5% (or about 5%) posteducational second zone foam material have a diameter, in excess of 700 microns.

In addition, in any of the above embodiments, the tube may comprise a plurality of ribs disposed around the bounding wall. These ribs can be extruded together with the tube to ensure General alignment with the longitudinal axis of the tube. Preferably, there are from three to eight ribs and, more specifically, from three to five ribs.

In addition to the above, in order to reduce or eliminate the formation of condensation inside the tube, and to maintain essentially uniform temperature in the gases flow through the tube during use, within the channel of the tube or within the tube wall may be provided with a heater such as a resistive heater wire.

In a particular embodiment of the tube has a length of 1,525 m (or thereabouts), weight 54 grams (or so), the proportion of voids 35% (or so), pneumatic elongation of 0.23 ml/cm H2O/m (or so), and the permeability of 85 g-mm/m2/day (or so). The tube is formed of 95% (or 95%) ARNITEL® VT 3108 and 5% (or about 5%) superconcentrate blowing agent-containing polyethylene and 20% (or about 20%) by weight Clariant HYDROCEROL® BIH-10E.

Further reference is made to Fig. 6A and 6B, which shows a vapor-permeable tube 601 in accordance, at least � one of the variants of the implementation. Fig. 6A shows a side view of the tube 601, whereas in Fig. 6B shows a cross-section of the tube 601 along the same side view of that shown in Fig. 2A. As in Fig. 6A, and Fig. 6B, a horizontal axis is shown as a straight 603-603. The wall of the tube, shown as wall 605 of Fig. 6B, is a vapor-permeable foam material, as described above. Wall 605 may have a thickness from 100 to 1500 μm (or from about 100 to about 1500 microns) for air tubing standard sizes with diameters from 12 mm to 20 mm (or from about 12 to about 20 mm) for applications in neonates and adults, respectively, and with length from 1 to 2 m (or from about 1 to about 2 m). However, the wall 605 may have a thickness up to 3 mm (or about 3 mm) and still provide a good ability to pass pairs.

The tube 601 is corrugated (i.e., the tube has a corrugated or grooved surface). A method of forming a corrugated tube is further discussed below in relation to Fig. 15. However, in some embodiments, the tube has a smooth surface.

Further reference is made to Fig. 7A and 7B, which shows a vapor-permeable tube 701 in accordance at least with one variant of implementation. Tube 701 is again made of vapor-permeable foamed material as described in any of the examples in this document�. The tube also includes a plurality of reinforcing ribs 703, which may be co-extruded with the tube. The shape of the ribs 703 is determined by the head with the matrix-screw extruder, and their size and the level of foaming is controlled by the temperature and pressure at which they come out of the head with the matrix.

The ribs 703 can be formed from foamed polymer, and the tube 701. Alternatively, the ribs 703 can be made of material different from material of the tube. This can be achieved through co-extrusion. As shown in Fig. 7 A, the tube 701 may be extruded with the established edges 703, and then can gamerbase with the formation of a "point" structure, shown in Fig. 7B. In certain embodiments, the tube contains from three to eight ribs, for example, three to five ribs. This extra strong tubes can be found independent of the application in one or more tubular components described in this specification in relation to medical paths.

Further reference is made to Fig. 8A and 8B illustrate an alternative configuration for ribbed permeable tube 801 in accordance at least with one variant of implementation. Fig. 8B extended fin 803 visible in the space between keravnos�Yami inside the tube 801. Fig. 8C shows heropress suitable for the formation of the tube shown in Fig. 8A and 8B. The unit includes extended parts 805 between the relief portions 807, which will be extended to form the ribs when the handset is removed from heropress. It should be understood that in addition to the tube can also be used other processes to improve in order to further improve its operational characteristics (such as elastic deformation, tensile strength, resistance to flow the resistance to bending and wrinkling). These processes may or may not be integrated in the process of formation of the tube.

Further reference is made to Fig. 9, which shows another example of a medical circuit in accordance at least with one variant of implementation. The circuit includes two permeable tube containing vapor-permeable foamed polymer as described above, namely, the tube 103 to breath and the tube 117 to exhale. The properties of the tube 103 to the breathing tube 117 to exhale similar to the properties of the tubes described above in relation to Fig. 1. The tube 103 to breath has an inlet 109, interacting with humidifier 115, and an outlet opening 113 through which the humidified gases are delivered to the patient 101. The tube 117 to exhale also has an inlet 109, which adopts the expiration�Amie humidified gases from the patient, and the outlet 113. As described above in relation to Fig. 1, the inlet tube 113 117 for exhalation can throw exhaled gases in the atmosphere, on the block fan/blower 115, air cleaner/air filter (not shown) or in any other suitable location.

As described above in relation to Fig. 1, the filaments 901 can be placed inside the tube 103 to breath and/or tube 117 for exhalation to reduce the risk of condensation in the tubes by increasing the temperature above the saturation temperature.

In this example, the tube 117 to exhale includes a connector (in this case, the Y-shaped connector 903) for connection with other components. For example, the Y-shaped connector 903 is configured for connection with a pipe 103 to breath and a patient interface (not shown). Naturally, an implementation option in Fig. 9 is only an example configuration. Component according to at least one of the embodiments, includes a tube of permeable foamed polymer. The component may further include a matching connector. Preferably, the connector also includes a vapor-permeable foamed polymer.

Further reference is made to Fig. 10, which shows a coaxial tube 1001 in accordance, for men�her least with one variant of implementation. In this example, the coaxial tube 1001 is presented between the patient 101 and fan 1005. Exhaled gases and inhaled gases flow through the inner tube 1007 or in space 1009 between the inner tube 1007 and outer tube 1011. It should be understood that the outer tube 1011 may not be precisely aligned with an inner tube 1007. Rather, "coaxial" refers to the tube inside another tube. In the process of using water vapor, but not liquid water, is passed through the wall of the permeable foamed tube, as explained below.

Because of heat transfer, the inner tube 1007 tolerate inhaled gases within the space 1013, while the exhaled gases are carried in the space between 1009 inner tube 1007 and outer tube 1011. This configuration of the air flow is indicated by arrows.

Inner tube 1007 is formed with the use of permeable foam material described herein. Thus, the moisture in the space 1009 exhaled flow can pass through the permeable foam material for humidification of the inspiratory flow in the space 1013 of the inspiratory flow. When organizing the flow of gases in a counter current, as shown in the example, vapor-permeable material provides significant passive improve resilience� of the inspiratory flow.

In the coaxial tube 1001 fan 1005 may not receive information about the leak in the inner tube 1007. Such leakage may lead to a short circuit of the patient 101, which means that the patient 101 is not supplied with enough oxygen. Such a short circuit can be detected by placing the sensor from the patient in a coaxial tube 1001. The sensor can be placed in the connector 1015 from the patient. Short circuit closer to the fan 1005 will lead to the fact that the patient 101 will re-breathe air close to the patient 101. This will lead to increased concentrations of carbon dioxide in the space of 1013 inhaled flow close to the patient 101 that can be detected directly by the sensor CO2. Such a sensor may include any sensor from a number of commercially available at the present time. Alternatively, such a re-breathing may be detected by tracking the temperature of gases in the connector 1015 on the side of the patient, wherein increasing the temperature above a predetermined level indicates that the re-breathing.

In addition to the above, in order to reduce or eliminate the formation of condensate inside the inner tube 1007 or outer tube 1011, and to maintain essentially uniform tempera�URS in the gas stream through a coaxial tube 1001, within the inner tube 1007 or outer tube 1011 may be provided with a heater such as a resistive heater wire located within the spaces with gases 1009 or 1013 or inside of the walls of the inner tube 1007 or outer tube 1011.

In an alternative embodiment of the coaxial tube 1001 in which passive humidification is undesirable foam is vapor-permeable wall may be an outer wall of the outer tube 1011. With this arrangement, the outer tube 1011 is in communication with ambient air, and vapor-permeable wall allows for the exchange of water vapor between the relatively moist exhaled gases and the surrounding air. As a result there is the possibility of controlling and/or preventing the formation of condensate.

Respiratory mask

In the field of technology related to respiratory devices, there are a number of well-known respiratory masks which cover the nose and/or mouth of the patient to ensure a continuous seal around the nasal and/or oral region of the patient's face so that the gas for consumption by the patient could be fed under positive pressure. The use of such masks range from breathing at high altitudes (for example, aviation applications) to use in mining and Bo�LBE with fire, and to various medical diagnostic and therapeutic applications.

One use of such a mask is the treatment of respiratory humidification. This system usually consists of a fan, humidifier, breathing circuit and a patient interface, such as a mask or nasal hollow needle. In this form of treatment, the moist air is supplied to the patient and, due to the temperature difference between the humid air and the environment, humid air can condense to form water droplets. In cases where treatment is lengthy (up to several days), these droplets can form the accumulation of water in the mask that may interfere with treatment, increase the risk of unintentional inhalation of water by the patient and can cause discomfort and/or asphyxiation of the patient.

One of the requirements to such respiratory masks was to provide an effective seal around the face of the patient to prevent leakage of the injected gas. Usually in previous configurations of masks good seal of the mask to the face was achieved in many instances only with considerable discomfort for the patient. This is a key issue in these applications, especially in medical applications where the patient is required to wear such a mask continuously for several�hours or, possibly even days. In such situations, the patient will not tolerate the presence of a mask in a long time and, thus, the optimum therapeutic or diagnostic objectives will not be achieved or will be achieved with great difficulties and considerable discomfort for the patient.

The following describes the different improve the delivery of respiratory therapy. In particular, it describes the patient interface, which is wearable by the patient and includes, at least partially, water vapor permeable (breathable) region in the body of the patient interface, made of vapor-permeable foamed material as described herein. A large part of the body of the mask (or mask body as a whole) can be made from permeable foam material that allows you to take advantage of the unique strength characteristics and high ability to skip pairs.

Further reference is made to Fig. 11A and 11B, which show a respiratory mask 1101 in accordance at least with one variant of implementation. It should be understood that the patient interface may be used in providing respiratory directly or with a fan, which will be described below with reference to the application in the system to create positive pressure in respiratory ways� (PAP) with hydration. Also it should be understood that the following description can be applied to the nasal masks, oral masks, oronasal masks, nazalnam the cannula and full-face masks, as the materials have the ability to form self-supporting semi-rigid structure with high ability to pass steam, and not limited to very thin film structures of the prior art.

Mask 1101 includes a hollow body 1103 with the inlet 1105 for connection to a breathing tube to breathe. Mask 1101 is placed on the face of the patient 101 with mounting 1109 for the head, fastened around the back of the head of the patient 101. Limiting the power of fastening 1109 for the head, acting on the hollow body 1103, provides sufficient compressive force to the gasket 1111 mask to ensure a sufficient seal for the face of patient 101. Multiple pin clamps is connected to the housing for attaching sliders to connect the mask 1101 and fixing 1109 on the head. Exhaled gases can be released through a valve (not shown) in the mask 1101, an additional channel for exhalation (not shown) or by any other method known in the art.

A hollow body 1103 is constructed from foamed polymeric material as described herein. This material provides the required�th rigidity to mask 1101, and also has a high ability to pass pairs. Previous attempts to supply the mask 1101 permeable areas required the use of thin membranes to achieve a high enough ability to pass pairs. These membranes had to be kept additional gain, such as power frame mask, and they also needed protection from damage. The vapor-permeable region of the membrane is typically supported in the slotted areas of the mask frame. However, when using self-sustaining permeable foamed polymers described herein, large areas of the mask 1101 (or mask 1101 as a whole) can be made from a foamed polymer, which allows you to take advantage of the unique strength characteristics and high ability to skip pairs. The result is a self-supporting semi-rigid mask 1101, which can be completely permeable to vapour (and to have a high ability to pass pairs).

Alternatively, a hollow body 1103 may have a large cut out area on the front surface so that a hollow body 1103, in essence, consisted of a frame having an outer circumference. Inserts made from foam self-sustaining vapour-permeable material described herein can be placed in in�cuts and glued to prevent or reduce the formation of water droplets inside the mask 1101 during prolonged therapy with hydration, causing the moisture can escape to the surrounding atmosphere. There are a number of methods for attaching the permeable structure to the hollow housing 1103, which may include bonding, the methods of sound weld joint injection extrusion, or by means of a rigid connection clamps foam permeable insert and the hollow body 1103.

It should be understood that may be provided with additional reinforcing structures, for example, for the mask, made of vapor-permeable foamed material, in order to further customize the elastic properties of the component. For example, ribs may be added to the outer and/or inner surface of the mask. Can also be used by local variations in the wall thickness to increase or decrease certain areas for the purpose of adjusting to the facial features of the patient and/or to provide areas with greater ability to pass pairs. In particular, this type of amplification can be very useful for tuning the elastic properties of a component in certain directions, which are forecasted load pattern. These benefits were not possible, or they would not be so easy to achieve, with a very thin permeable membranes used previously.

Nasal hollow needle

Further reference is made to Fig. 12, which shows interface�the ys of the patient in the form of a nasal hollow needle 1201 in accordance, at least with one variant of implementation. Nasal hollow needle 1201 includes a housing, a hollow needle 1203 and short tube 1205 delivery. Foamed permeable polymer described herein can be used in the case of a hollow needle 1203 and/or short tube 1205 for controlling delivery and/or prevent condensation within spaces with gases of these components. As described earlier, can also be found used in a breathing tube 601 for breath.

Mount catheter

Another component of the medical circuit, which can be applied vapor permeable foamed polymers, this fastening of the catheter. The mounting of the catheter connects the patient interface, such as a mouthpiece, nasal mask or endotracheal tube and double tubes or breathing tubes breathing circuit. Connection with dual nozzles is usually done through a Y-shaped connector. During cycles of inhalation and exhalation of the patient each of the double tubes of the breathing loop plays distinct roles: one serves as a channel for inhalation, and the other as a channel for exhalation. The mounting of the catheter has a dual role, conveying and inhaled and exhaled gases. Accordingly, the mounting of the catheter has significant disadvantages. The volume exhaled �ozdoba remains in the mounting of the catheter between the exhale and the inhale. Accordingly, some amount of air may be re-inhaled by the patient. Although it is not unacceptable, repeated inhalation is usually undesirable and in the case where the likely significant repeated inhalation, may need to increase levels of supplied oxygen.

The gases inhaled by a patient, in a well-managed ventilation system are shipped in moisture conditions close to saturation level, and at a temperature close to the temperature of the body, usually from 33 to 37°C (or from about 33 to about 37°C). This temperature can be maintained by the heater in the breathing tube for breathing, located in the vicinity of the point at which the gases enter the fastening of the catheter. Gases exhaled by the patient, return completely saturated and subjected to additional cooling in the process of passing through the fastening of the catheter. Accordingly, while on the inner walls in the process of inhalation of the patient, a small amount of condensate, significant levels of condensation can form during exhalation of the patient. Condensation, or "precipitation" events inside the catheter mounts, is particularly harmful because of its proximity to the patient. The movable condensate, which has breathed, or breathes, the patient, can lead to coughing or other discomfort.

p> Further reference is made to Fig. 13, which shows the fastening of the catheter 1301 in accordance at least with one variant of implementation. The mounting of the catheter 1301 includes a Y-shaped connection 1303 fan side. Inner tube 1305 is extended coaxially with the outer tube 1307. Inner tube 1305 is supported by the patient-side connector 1309 inner tube which, in turn, is supported via a supporting strut connector 1311 1313 from the patient. Inner tube 1305 is supported at its other end a second connector 1315 inner tube which forms part of a Y-connector 1303 fan side.

The second connector 1315 inner tube communicates with the connector 1317 breathing tube to breath. At least part of the external wall of the tube 1307 made of vapor-permeable foamed material as described herein. In certain embodiments, the outer tube 1307 completely made of vapor-permeable foamed material.

Thus, in the process of using inspiratory flow is included in the attachment of the catheter 1301, as shown by the arrow 1319. Inspiratory flow passes through the inner tube 1305 and goes to the patient through the connector 1313 from the patient, as shown by the arrows 1319. Pic�e exhalation of the patient, an authoritative or nonauthoritative, exhaled gases pass through the connector 1313 from the patient into the space, bounding the inner tube 1305, as shown by the arrows 1321. These gases pass along the inside wall of the outer tube 1307, as shown by the arrows 1321, and go outside through the connector 1323 breathing tube for the expiration of the Y connector 1303, as shown by the arrow 1325. When passing through the fixation catheter 1301 within the space between the inner tube 1305 and outer tube 1307, water vapor can pass through the water vapor permeable foamed outer tube 1307. In certain embodiments, the outer tube 1307 is entirely permeable. Thus, despite the fact that exhaled gases can experience a slight drop in temperature during their passage through the attachment of the catheter to the connector 1301 1323 breathing tube for the expiration, in close connection with the drop in temperature is a decrease humidity by passing water vapor through a vapor-permeable foamed material of the outer tube 1307. Accordingly, the relative saturation of the respiratory flow decreases, and thereby also reduces the formation of condensation. Of the tube wall is made of vapor-permeable foamed material can have a thickness of from 0 to 3 mm (or from about 0.1 to about 3.0 mm) and can be quite hard for so they were self-supporting and semi-rigid and still maintained a high ability to pass pairs.

The mounting of the catheter 1301 containing vapor-permeable foamed polymers, described herein, has a clear separation of the flow of inhalation and exhalation through the fixation catheter 1301, whereby significantly reduced re-inhalation. Condensation is also reduced by reducing the humidity of the exhaled gases, even when the temperature of these gases.

System component insufflation and smoke

Laparoscopic surgery, also called minimally invasive surgery (MIS), or keyhole surgery, is a modern surgical technique in which operations in the abdomen are performed through small incisions (usually 0.5-1.5 cm) as compared to larger incisions needed in traditional surgical procedures. Laparoscopic surgery includes operations within the abdominal or pelvic cavities.

In the process of laparoscopic surgery with insufflation may also be desirable to insufficieny gas (usually CO2) moistened before passing into the abdominal cavity. This can help prevent "drying up" of the internal organs of the patient and can reduce the amount of times�, required for recovery after surgery. Even if using dry gas for insufflation, gas can become saturated when it absorbs moisture from the body cavity of the patient. The moisture in the gases tend to condense on the walls of the discharge pipe or channel system insufflation. Water vapor can also condense on other components of the system, insufflation, such as filters. Condensation as a result of any moisture vapor on the filter and a flow of condensate through the nozzles (inlet or outlet) is highly undesirable. For example, water that has condensed on the walls, can saturate the filter and cause it to lock. This potentially causes an increase in counter-pressure and prevents the system to perform the removal of smoke. In addition, liquid water in the pipes can go into other connected equipment, which is undesirable.

For example, in abdominal surgery in the abdominal cavity usually insufflated carbon dioxide with the aim of creating a space of work and observation. Typically, the gas is used as CO2that is normal for the human body and can be absorbed and removed by the respiratory system. He is also non-flammable, which is important because laparoscopic procedures are usually used�tsya electrosurgical instruments. Common practice in laparoscopic surgery was the use of dry gases. However, for CO2or other insufflating gas is desirable to hold moisture to pass through the abdominal cavity. This can help prevent "drying up" of the internal organs of the patient, and can reduce the amount of time needed for recovery after surgery. The insufflation system usually include a humidification chamber, which contains some amount of water. Humidifier typically includes a heating plate that heats the water to produce steam, which is transmitted to the incoming gases to humidify gases. Gases are transported from the humidifier with water vapor.

In surgical procedures often used electrosurgery or electroacoustic, or increases the use of lasers. When the use of such devices there is a tendency to the formation of surgical smoke in the workspace due to the burning of the tissue. System remove smoke, which use the outlet or discharge portion, typically used to remove smoke from the surgical field, so the surgeon can see what he or she is doing, and so this potentially dangerous material was left inside the body cavity after surgical�about intervention. One end of the discharge pipe or meets, or is inserted, into the second section (or sometimes in the same incision). A typical fume extraction system typically includes a trocar and cannula at its end to facilitate insertion into the surgical field. The smoke comes out of subjected to insufflation of the abdominal area through the exhaust pipe. The discharge port may be attached to the end of the laparoscopic instrument in order to ensure the removal of near the place where electracoustic. Usually gases and smoke from the body cavity is filtered through a filter to remove solid particles before they are emitted to the atmosphere. The filter can optionally be designed to remove chemicals and any harmful microorganisms from surgical smoke.

Further reference is made to Fig. 14, which shows the insufflation system 1401, in accordance at least with one variant of implementation. The insufflation system 1401 includes insufflator 1403, which creates a thread insufflating gases under pressure above atmospheric, for delivery into the abdominal or peritoneal cavity of the patient 1405. Gases pass into the humidifier 1407, which includes heating the Foundation 1409 and the camera 1411 humidifier, the camera 1411 in the process of using interactive whiteboard�meets with a heating basis 1409 thus, that the heating plate 1409 delivers the heat to the chamber 1411. In the humidifier 1407 insufflate gases pass through the chamber 1411, with the result that they become hydrated to an appropriate moisture level.

System 1401 includes a channel 1413 delivery, which connects the camera 1411 humidifier and the peritoneal cavity of the patient 1405 or operating field. Channel 1413 includes a first end and a second end, the first end connected to the outlet of the chamber 1411 humidifier and takes humidified gases from the chamber 1411. The second end of the channel 1413 is placed in the operative field of the patient 1405 or peritoneal cavity, and hydrated insufflate gases are carried from the chamber 1411 through the channel 1413 in the operative field to implement insufflation and expansion of the surgical field or the peritoneal cavity. The system also includes a controller (not shown) which controls the amount of moisture supplied to the gases, by controlling the power supplied to the heater based 1409. The controller can also be used to track water in the chamber 1411 humidifier 1411. The system shown 1415 removal of smoke coming out of the body cavity of the patient 1405.

System 1415 remove smoke can be used in conjunction with the system 1401 insufflation described above, or can be used with other coming�them insufflation systems. System 1415 remove smoke includes a nozzle 1417 emission or release, block 1419 output and filter 1421. The pipe 1417 emission connects the filter unit 1421 and 1419 emissions, which in use are placed in the operative field of the patient 1405 or peritoneally cavity, or adjacent to them. The pipe 1417 release is a self-supporting tube (i.e., tube, capable of supporting its own weight without buckling) with two open ends: the end of the surgical field and the output end.

Gases supplied to the system 1401 insufflation, already moist at the entry point into the body cavity of the patient 1405. Since the body cavity is already wet and moist, gases have no tendency to loss of moisture in the body, and can become fully saturated, if they are not yet at saturation point. If the gases are dry when entering the body cavity, they tend to get hydrated in the process of passing through the body cavity, collecting the moisture from the damp atmosphere in the cavity of the body on internal organs.

When saturated gases exit from the body cavity of the patient 1405, they pass along the cooler walls of the nozzle 1417 release, which usually has a length of 1 m (or so). The moisture in the gases tend to condense from the gas on the walls of the pipe 1417 emission unit 1419 ejection and/or filter 1421. Condensate� pair on the filter 1421 and excess moisture along the pipe 1417 emissions as a result of condensation of moisture on the walls can lead to saturation of the filter 1421 and call it a lock. This potentially leads to increased back pressure and prevents clear smoke system.

Condensed moisture from the filter 1421 may lead to partial or complete blocking of filter 1421, which will increase back pressure and reduce efficiency of the filter because of the lock. This is unfavorable because of the increased back pressure prevents effective cleaning of surgical smoke system. Surgical smoke, remaining at the surgical site within a surgical cavity or inside the channel removal systems can be dangerous for the patient because the surgical smoke contains several potential toxins that can settle in the surgical cavity or tissue of the patient 1405. Review surgeons may be blocked or impeded by surgical smoke remaining in the surgery site and not removed, potentially resulting in a dangerous working environment for surgeons. Condensation may partially block the filter 1421 that will reduce filtering toxins from surgical smoke. This can lead to the ingress of potentially hazardous substances such as odors, surgical smoke and dead cellular matter in the operative field. Such articles can be hazardous to health and can lead to many problems with health�will aviem the doctors and the patient.

At least one of the embodiments includes the use of that pipe 1417 emission having a permeable wall or wall of the nozzle, which contains a vapor permeable material, will help to alleviate this problem. In particular, vapor-permeable foamed material as described herein is particularly suitable for the formation of this type of channel pipe 1417 release insufflation system, due to the previously described properties discussed in relation to the foam material, component, and breathing tubes. A certain amount of moisture from the discharged gas passes through the wall of the pipe 1417 release before reaching the filter 1421, and therefore, in Gaza there is less moisture, which can condense from the gas and clog the filter 1421. Accordingly, the nozzle 1417 ejection is preferably made of foamed material in accordance with this document. The manufacturing process of the breathing tube are described in detail below, can be directly applied to the tubing insufflation system, including input and output (to smoke) a pipe.

Method of production

Further reference is made to Fig. 15, which illustrates a typical method of manufacturing a vapor-permeable component, suitable for delivery of gas, such as �cutting Fig. 2A and Fig. 2B, or any other tube, discussed in this document in accordance with at least one of the variants of the implementation.

Generally speaking, the method of manufacturing a component comprises mixing a blowing agent with a polymer base material and forming a liquefied mixture. Allowed the release of gas bubbles from the blowing agent in the portion of the liquefied mixture containing core material. Then the release of gas bubbles is blocked, and the mixture is subjected to solidification to form the desired component. The desired properties of the final component are discussed above.

In at least one embodiment of the process used to create the component, such as a respiratory tube includes extruding molten extrudate 1501 in heropress 1503 for the formation of the desired component, such as a tube 1505. In certain embodiments, the polymeric base material for the extrudate has a diffusion coefficient exceeding 0,75×10-7cm2/s (or so). The core material may have the following characteristics stiffness: (a) the modulus of elasticity in tension greater than 15 MPa (about 15 MPa), which may be desirable for the core materials based on thermoplastic urethane elastomer (or OS�IOD-based material TPU, in accordance with as defined in ISO 18064:2003(E)); or (b) the modulus of elasticity in tension greater than 100 MPa (about 100 MPa), which may be desirable for basic materials on the basis sobolifera thermoplastic elastomers (or core materials based on TPC, in accordance with the determined 18064:2003(E)), such as the main materials on the basis of ARNITEL®. The above properties are given only as an example. Basic material need not have these properties to obtain a foam with the desired ability to pass vapor and stiffness, and typical values of the modules is clearly not limited to the main materials on the basis of TPU and TPC.

It was found that screw extruder such as a screw extruder Welex, equipped with a helix with a diameter of 30 mm and a mouthpiece with a ring-shaped nozzle 12 mm with a gap of 0.5 mm, suitable for rapid production of tubes with low cost. After exiting the mouthpiece 1507 with an annular nozzle, the molten tube 1501 is able to pass through a set of rotating matrices or blocks on heropress 1503. It was also found that appropriate is heropress, such as manufactured and supplied by the company UNICOR®. It forms the corrugated tube 1505.

The method described above is given merely as an example. Are also appropriate alternative �the means of forming components, containing foamed materials described herein. For example, another method of manufacturing a vapor-permeable component includes extruding ribbons of foam material, winding the foam tape on the core, and sealing the seams of the wound tape drops (such as drops of foam material).

Foaming in the extrusion process can be performed in various ways, including physical foaming and chemical foaming.

Physical foaming, the foaming agent is an inert gas (e.g. CO2or N2), which is injected through the cylinder of the extruder at a flow rate and pressure high enough for it to dissolve in the molten polymer. For example, can be suitable pressures exceeding 100 bar (about 100 bar) and a flow equal to 1% (or about 1%) of the flow rate of the polymer. Preferably, nuclearmoose agent is also introduced into the polymer to create places for the expansion of the bubbles of the foam. An example of such method includes the use of commercial block for Sulzer injection of inert gases at the end of the barrel and the gas mixing using a static mixer to the nozzle exit.

Chemical foaming involves adding a chemical agent which is endocervically chemical decomposition (endothermic or exothermic) when heated, whereby gases are released. Gases dissolve in the polymer melt during the extrusion process, since the pressure in the melt exceeds the critical pressure solubility for gases. Gases come out of solution when the pressure is, for example, at the outlet of a mouthpiece of the head (or shortly after). Foaming agents act as plasticizers, thereby decreasing the viscosity of the melt. The lower viscosity leads to a decrease of pressure in the melt at a given temperature, shear rate and the geometry of the mouthpiece head. Accordingly, to perform the work to ensure that gases do not froth ahead of time, by maintaining a pressure in the extruder above the critical pressure of dissolution. Such pressure can be maintained by controlling the shear rate in a mouthpiece head and/or the temperature of the melt.

The typical process suitable for the foaming of the material in the extruder prior to the corrugation of the tubing, includes adding a chemical blowing agent in the amount of from 0.3 to 1.5% (or from about 0.3 to about 1.5%) by weight of the main polymer (such as ARNITEL® VT 3108). This can be achieved by direct mixing of the blowing agent powder (such as HYDROCEROL® CT 671 or equivalent) basic polymer, or through original mix� "superconcentrate" blowing agent (i.e., the mixture of the carrier polymer, such as polyethylene, and active blowing agent (such as HYDROCEROL® BIH-10E or equivalent) at 80/20% or about 80/20% by weight of the carrier polymer with the active foaming agent prior to the issuance of the mixture in the feed zone of the extruder barrel. In the first case, the powder blowing agent is a blowing agent. In the second case, "superconcentrate" blowing agent is a blowing agent. HYDROCEROL® CT 671 has a temperature decay of 160°C and pressure the solubility of 60 bar. ARNITEL® VT 3108 has a melting point of 185°C. Therefore, in this example, the extrusion temperature of processing can be reduced by an amount of from 10 to 20°C (or from about 10 to about 20°C) to prevent pressure drops below a critical value, since the decline of the melting temperature increases viscosity.

Shear rate (via the speed of the extruder) are set high enough to ensure that the pressure was above the critical pressure, as well as to ensure that the blowing agent is well mixed with the molten polymer. After the polymer comes out of the mouthpiece head starts to happen foaming and you can see the formation of bubbles, and the bubbles expand until the polymer will not be cooled to the point at which the force of expanding bubbles mill�become less forces required to deform the molten polymer (e.g., below the melting point of the polymer or below the temperature of activation of the blowing agents, in which the foaming reaction begins/ends). Cooling starts when the polymer is included in heropress and molded on blocks heropress. These blocks, in turn, are cooled by a supply of heropress and vacuum forming.

After foaming component comprises a corrugated tube having a foam cell-like voids distributed throughout the wall thickness of the component. It was found that for a typical component of the respiratory tube diameter size of voids not exceeding 700 μm (95% level of significance) in the transverse direction, may allow to obtain the desired product. However, it is useful to size the diameter of the voids in the transverse direction was less than 700 microns to prevent the expansion of voids throughout the thickness of the tube wall and the channel leakage. For example, in some embodiments, the size of the diameter of the voids in the transverse direction may not exceed 500 μm (95% level of significance). It was also found that the size of the diameter of the voids in the transverse direction between 75 and 300 μm (or from about 75 to about 300 microns) allows to obtain a high quality product for medical circuits. The maximum size of the diameter of the STS�from in the transverse direction will depend on the minimum wall thickness of the component. For example, the maximum size of the diameter of the voids in the transverse direction may be limited to less than half (or about half) the minimum wall thickness. However, the maximum diameter size of voids in the cross direction may be less than one-third (or about one third), less than 30% (or about 30%, or even less than one-fourth (or about one-fourth) the minimum wall thickness.

As discussed above, blowing bubbles cease to grow with the cooling material. It was found that rapid cooling leads to the formation of two zones in wall thickness. Fig. 16A and 16B shows the extruded foamed material containing two zones, in accordance at least with one variant of implementation. The first area 1601, of a thickness of 100 μm (or thickness of about 100 μm), is formed as an outer shell of foam material with closed cells on the surface which is in contact with the profiles/units heropress. In this zone, the average and maximum size of the voids is less and less likely that the shell will form a leakage path through the wall. In the remaining second area 1603 the material is cooled slowly, and the large size of voids can lead to open cells. Accordingly, at least one of the variants of the implementation involves using the fact that m�is to enhance rapid cooling of the material after the start foaming from the output of a mouthpiece of the head.

The cooling tube is part of the pleating process and occurs after the onset of its interaction with blocks of heropress (metal blocks, which are mechanically applied profile shape). Rapid cooling is achieved by maintaining a low temperature units heropress, for example, 15°C (or about 15°C), with the use of a refrigerant such as water. Rapid cooling may also be achieved by modifying the melting temperature at the outlet of the extruder (and before contact with the blocks) at a temperature close to the melting point of the polymer, so that the melted plastic quickly became solid. This can be achieved by creating an air gap between the extruder and gameprison, which can be supplemented with a cooling gas and/or air jets or liquid bath such as water bath. Rapid cooling can also be achieved by increasing the vacuum pressure in the blocks, whereby the polymer is "sucked" into the metal mold very quickly, and thus cooled to the moment when the vesicles fully expanded. One or more of such techniques can be used individually or in combination to achieve rapid cooling in different variants of implementation.

The formation of the membrane depends not only on fast�about cooling. The formation of the membrane also depends on the composition of the material (such as the level of expansion), the speed of the extruder, the temperature and pressure of melting, the period until the cooling water temperature and duration of the bath, and, finally, the speed of withdrawal (the mechanism that pulls the formed tube from the extruder). Rapid cooling depends largely on the rate of diversion, period and water temperature.

As a result, the thickness of the shell can range from 5% to 10% (or from about 5 to about 10%) from the wall thickness, for example, from 10 to 50 μm (or from about 10 to about 50 microns). Both the first and the second zone are empty. In certain embodiments, no more than 5% (or about 5%) of voids in the first zone have a diameter greater than 100 microns. The voids in the second zone is greater than the voids in the first zone. For example, in some embodiments, not more than 5% (or about 5%) voids specified second zone foam material have a diameter greater than 700 microns.

Further reference is made to Fig. 17, which describes a typical method of manufacture of a tube in accordance at least with one variant of implementation. In a typical method, a blowing agent is first mixed with the main material with the formation of the extrudate, as shown in block 1701. The basic material contains one or more vapor permeable thermoplastic e�of Stamenov, having the diffusion coefficient exceeding 0,75×10-7cm2/s (or about 0.75×10-7cm2/s), and the modulus of elasticity in tension, greater than about 15 MPa. Then the extrudate is attached pressure using an extruder to form a hollow tube, as shown in block 1703. The hollow tube is delivered in the form of heropress, as shown in block 1705. The hollow tube is cooled in the form of heropress whereby allowed the release of gas bubbles from a portion of the extrudate formed by the foaming agent, as shown in block 1707. Finally, the cooled tube is removed from heropress, as shown in block 1709, whereby is formed a tube containing solid thermoplastic elastomer and voids formed by gas bubbles. In this example, the resulting tube has a wall thickness of from 0.1 to 3.0 mm or from about 0.1 to about 3.0 mm). And the maximum size of the cavities is less than one-third (or about one third) of minimum wall thickness and the proportion of voids in corrugated tube exceeds 25% (or about 25%).

Measurement

The above characteristics, which includes the module, the proportion of voids, weight, diameter, thickness and diffusivity. Below are the preferred methods for measuring these characteristics. All measurements are performed at room temperature�round (23°C or so).

A. Module

Measurement of tensile strength was conducted to determine the relationship between force and stretch foam corrugated tubes at a constant expansion. It was determined that the relationship is usually linear up to 10% extension. Machine to check tensile strength (Instron) equipped with the 500N force gauge was used to conduct this experiment, and samples of corrugated tubes with a length of 200 mm were used as test samples.

(Numerical) model 2D axisymmetric finite element was used to obtain values of young's modulus on the basis of the experiment. The geometry of this model was designed on the basis of measurements of the corrugated tubes. The model includes linear elastic material behavior (Hooke's law) for the analysis module (E). The use of linear-elastic materials in the model is justified in terms of a small expansion. The model was fixed at one end and stretched at the other end with a constant load to simulate the behavior similar to that seen in Instron machine. Expansion values for various modules (E) was removed from the model, and these models were compared with the data in experiment Instron in accordance with the following equation:

where

F pre�is a virtue

L represents the length of the sample,

ε is an extension.

The module was chosen as the value that corresponds to the equality between the model and the experiment. Verification experiment was conducted using a corrugated tube with a known module, and the results are well consistent with the numerical model.

B. measuring the percentage of voids

The proportion of voids (Φν) sample foamed polymer is defined in the formula (1) as:

(1)

where ρ(S) is the density of the foamed polymer sample, and ρ(P) is the density of the corresponding expanded polymer. Examples of two methods for measuring ρ(S) method are the buoyancy force and displacement method described below.

The method includes the buoyancy force in mass measurement of the sample, suspended in the air (M1), and then measure the mass of the sample suspended in a liquid with known low density (M2), such as heptane. The density of the sample foamed polymer may be calculated in accordance with formula (2) as follows:

where ρFrepresents the density of the suspension liquid. Method of buoyancy suitable for small samples, when the density of the sample is higher than the density of the liquid suspension. For example, if the suspension liquid heptane is used, this method is suitable for samples foamed ARNITEL®, having a percentage of voids of less than 45%.

Displacement includes calculating the volume of a sample by measuring the volume of liquid that it displaces. Using digital altimeter measured the height of the marks on the empty graduated cylinder. This gives a calibrated relationship between height and volume. Then the cylinder is placed a liquid, and is determined by the height of liquid in the cylinder by measuring to the bottom of the concave meniscus or to the top of the concave meniscus. This gives the initial volume (V1). Then, the foamed polymer sample of known dry mass (M1) is placed in the liquid, and again is determined by the height of liquid in the cylinder. This gives the final volume (V2). The density of the foamed polymer sample is calculated in accordance with formula (3):

(3)

Despite the fact that in the method of displacement requires large sample sizes to obtain sufficient�full-time precision, it allows you to measure samples of lower density, because the specimen may be shipped and may be held in place.

C. Mass

All weights were obtained using configuration reference microbalance Vibra AJ 420 CE company Shinko Denshi Co. (Plant #504068).

D. Thickness and diameter

The thickness and/or diameter samples can be obtained as follows.

For tubular specimens for measurement of diameters can be used Mitutoyo digital Vernier caliper (model CD-8 CSX). The diameters of the samples can be measured in many points, and a simple average of the measurement data can be taken as the diameter of the sample.

For film samples of thickness can be obtained in a variety of points using a micrometer scale with a Vernier Mitutoyo D(0-25 mm) RH NEO MODELSHOP. Again, a simple average is taken as the thickness of the sample.

To measure the thickness of the corrugated tube of the sample tube can be cut into sections, and multiple measurements can be performed using a digital caliper at different positions along the profile. Can be calculated from the average thickness, weighted by the area. Alternatively, a calibrated microscope, such as a microscope Meiju Techno, can also be used to measure the thickness of corrugated pipe sample. The method can include you�olnine many measurements (typically more than 90) the maximum and minimum thickness along the length of the tube in different positions on the circle. This is achieved by cutting the tube in half, but along a helical path, which covers 45 ribbings at the turn of the screw.

E. Diffusivity

Time-dependent sorption and desorption of water by polymeric systems is a function of diffusivity of water in the polymer. In the work of a Crank J. The mathematics of diffusion. 2nd ed. Oxford: Clarendon Press; 1975 presents a detailed description of how experimental data can be analyzed to obtain the diffusion coefficient of water in the polymer. Pages 46-49, 60, 61 and 72-75 work crank (Crank) is hereby incorporated herein by reference.

According Cranko, in the case where the diffusion coefficient D is constant, the desorption/absorption of water in the sample thickness is determined by the formula 4.

(4)

where:

is a relative loss or increase in mass

M(t)=m(t)-m(0), g

M(∞)= m(∞)-m(0), g

m(0) is the mass at time=0, g

m(t) is the mass at time=t, in grams

m(∞) represents the mass of the sample through a very long period of time, in grams

n represents the n-th member in the endless amount

(5)

(6)

D represents the diffusion coefficient, cm2/s

t represents the time, and

21 represents the thickness of the sample, see

In formula 4 the first degree for n=1 (i.e., with A1and β1) becomes a dominant member values for>0,4.

The alternative representation foris obtained by solving the diffusion equation using Laplace transforms. The result is shown in the work of crunk and reproduced below:

(7)

where

and

erfc(x) is the complementary error function of x.

In short intervals for values<0.4, the only member of theVNU�ri curly brackets {-} contributor. In the formula (7) it is assumed that graphicsdepending onwill be straight with a slope equal to.

Fig. 18 shows an idealized curve of sorption/desorption with a constant diffusion coefficient D=3,0×10-7cm2andl=0,075 see Curves in real experiments, as shown in Fig. 19, different from the idealized curve. Compared to the idealized curve, the relative change in mass on the experimental curves looks backward in time, and the resulting experimental curves are sigmoidal. The sigmoidal shape is obtained when desorption of water from the film is limited by the rate of evaporation on the surfaces of the film. This is described mathematically as a boundary condition in equation (8) on the surface of the material.

(8)

where

C0represents the concentration in the film, which would be in equilibrium with the external environment, g/cm3

Csrepresents the concentration of water directly on the inside surface, g/cm3and

α is a constant related to the rate of evaporation at the surface, cm/s.

With ISPA�the group analogue of formula (1) can be represented in accordance with formula (9).

(9)

where

(10)

and βηis a solution of the equation L=βntan(βn) (11)

Again, for large periods of time when0,4, in equation (9) dominates the first exponent (n=1), with A1and β1.With increasing αand therefore L, Anand βnreduced to definitions in formulas (5) and (6).

Because of the existence of a strong relation between β, L and D in the formula (9) may also be desirable for the removal of D from the data for small values of time. In the case of ideal diffusion the diffusion coefficient D has been removed by examining the experimental data for small time values by using the formula (7). The corresponding formula for the formula (7) with boundary condition given by formula (8) in the work of a crank, not shown. Accordingly, solutions of Laplace transforms were derived through the States n=2. For values of0,4, formula (12) gives a very accurate approximation of the actual results.

the higher-order terms(12)

For small values of time the members of the higher-order terms are small and can be neglected.

Using the above output, the typical method of calculating diffusivity as follows:

1. The collection of experimental data on(a relative decrease or increase in mass) over time (t) in seconds. For the desorption experiment this is done by the initial equilibration of the sample with a known dry weight with steam at a controlled RH and the measurement of the weight of the sample at different points in time, including its initial value m(0). The measurement is performed until, until the weight no longer changes, m(∞). All measurements are performed while blowing dry air over the sample at a speed of from 10 to 30 l/min (or about 10-30 l/min) to reduce the effect of evaporation on the experimental observations.

2. Calculation of grams of water per gram of dry polymer (W%) at each time point. Based on these data and other experiments, calculate the value of l(t) at each time point, 2l(t) is the thickness of sample in cm.

3. The choice of the initial values (or first� estimates) of L and D.

4. The definition of the function G(f) derived from formula (12) in accordance with formula (13):

(13)

5. Calculating values of G(t) using initial estimates of L and D.

6. Plotting G(t) depending onand, by the slope of the first four data points, the calculation of comparative values for D using the formula (14):

(14)

7. Using the initial value L in step 3, repeat steps 5 and 6 until convergence D. This determines D and L as input for subsequent steps.

8. Using a value L from step 3 calculation of the first six roots of the βη(n=1...6) according to the formula (11).

9. From the experiment, the calculation of a value

(15)

at each moment of time t. From the formula (9) at large times, the formula (15) is equivalent to the ratio specified below in formula (16):

(16)

10. Accordingly, the value calculated according to the formula (15), are plotted based on.

11. The slope of this graph in the rangeand the value of β1calculated in step 8 can be calculated with the new value of D using the formula (16).

12. Setting the value of L in step 3, and repeat steps 4-11 until then, until the value D in step 11 and the value D in step 7 will not be the same. It specifies a unique value for L and D, which satisfy the formula (9) and the formula (12).

13. Record the values of D, L, A1and βnfor n=1...6. The full calculation of the curve by using the formula (9) and the calculation and recording of R2for curve fitting. Fig. 20 shows the results of the above calculation for a tube for children of foamed polymer. The tube contains the sample MB-27 6% with a share of voids 52%, at a flow rate of 16.7 l/min, RH=100%, D=1,228×10-6cm2/sec, and L=3,5697. R2for curve fit amounted 0,9998.

The above description of the invention includes in its preferred form. It can be modified without departing from the scope of the invention. Specialists in the art to which the description refers, will clear many of the changes � design and very different versions of implementation and use, without deviation from the scope of the invention in accordance with a defined in the appended claims. Of presentation and the descriptions herein are purely illustrative and are not assumed to be limiting in any sense.

1. The exhalation pipe for breathing circuit to transfer humidified gases exhaled by the patient, the exhalation pipe contains:
inlet and outlet ports; and
channel of foamed polymer, which is water vapor permeable and essentially impermeable to liquid water and the volumetric flow of gas, wherein the channel of foamed polymer provides for the humidified gas from the inlet to the outlet within the space defined by the channel
in this case, the channel of foamed polymer includes solid thermoplastic elastomeric material and cell voids distributed within a solid material.

2. The pipe according to claim 1, wherein the channel of foamed polymer has a diffusion coefficient greater than 3×10-7cm2/S.

3. The pipe according to claim 1, wherein at least some of the cell voids are connected to other cell cavities, whereby there are formed open cell pathways, contributing to the movement of water vapor through the channel of foamed polymer.

4. The pipe according to claim 2, wherein at least 10% of the cell cavities are connected to other cell cavities.

5. The nozzle according to claim 3, in which at least 20% of the cell cavities are connected to other cell cavities.

6. The pipe according to any one of claims. 1-4, in which the channel of foamed polymer is extruded.

7. The pipe according to claim 1, wherein the channel of foamed polymer is crimped.

8. The pipe according to claim 1, further comprising a plurality of ribs disposed circumferentially around the inner surface of the channel of foamed polymer attached to the space enclosed by the channel and is generally longitudinally aligned along the length of the channel of foamed polymer between the inlet and outlet holes.

9. The pipe according to claim 1, further comprising a heating wire, mostly longitudinally aligned along the length of the channel of foamed polymer between the inlet and outlet holes.

10. The pipe according to claim 1, wherein the channel of foamed polymer has a percentage of voids, greater than 25%.

11. The pipe according to claim 1, wherein at least 80% of voids tapered along the longitudinal axis of the channel and has a ratio of longitudinal length and a transverse height greater than 2:1.

12. The pipe according to claim 10, in which at least 80% of voids tapered along the longitudinal axis of the channel and the ima�t the ratio of longitudinal length and a transverse height, exceeding 3:1.

13. The pipe according to claim 1, wherein the channel of foamed polymer has a wall thickness of from 0.1 mm to 3.0 mm.

14. The pipe according to claim 1, wherein the average size of the voids in the transverse direction less than 30% of the thickness of the duct wall of foamed polymer.

15. The nozzle according to claim 13, in which the average size of the voids in the transverse direction less than 10% of the thickness of the duct wall of foamed polymer.

16. The pipe according to claim 1, wherein the permeability of the R channel of foamed polymer in g-mm/m2/day is at least 60 g-mm/m2/day when measured in accordance with procedure A of ASTM E96 (method of drying at 23°C and a relative humidity of 90%), and satisfies the formula:
P>exp{is 0.019(ln (M)]2A -0.7 ln(M)+6,5},
where M represents the modulus of elasticity of foamed polymer in MPa and M is in the range from 30 to 1000 MPa.

17. The pipe according to claim 1, wherein the channel of foamed polymer further has an outer casing in which the cell voids are closed cell.

18. The pipe according to claim 1, wherein the channel of foamed polymer is sufficiently rigid to ensure that the channel from a foamed polymer could be bent around a metal cylinder with a diameter of 25 mm without kinking or damage, in accordance with the test to improve the resistance to flow when �the bending according to ISO 5367:2000(E).

19. The pipe according to claim 1, wherein the channel of foamed polymer is made with possibility of accommodation between the fan and the patient and configured to deliver humidified gas from the patient to the ventilator.

20. The pipe according to claim 1, wherein the channel of foamed polymer comprises at least 80% of the length of the exhalation pipe.

21. The pipe according to claim 1, wherein the channel of foamed polymer transports water vapor from the humidified gases within the channel to the surrounding atmosphere, thereby decreasing the formation of condensation within the channel.

22. The pipe according to claim 1, wherein the channel of the foamed polymer comprises a mixture of polymers.

23. The pipe according to claim 1, wherein the vapor-permeable foam material includes a thermoplastic elastomer with a polyether soft segment.

24. The pipe according to claim 1, wherein the vapor-permeable foamed material includes spoliatory thermoplastic elastomer with a polyether soft segment.



 

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SUBSTANCE: group of inventions refers to medical equipment. An automated oxygen delivery system comprises an patient's blood flow oxygen measuring sensor comprising a pulse oxymeter; a pneumatic sub-system comprising a gas feed connected to an oxygen inlet, an air inlet and a gas-mixture outlet for mixing oxygen and air to form gas mixture having the oxygen concentration delivered to the patient, and for delivering gas mixture to the patient; and a control sub-system connected to the sensor and the pneumatic sub-system comprising an input. A sensor interface is configured to receive the measurement data and the state information related to the sensor measurement data. The state information involves a perfusion index and a signal quality measure. A pneumatic sub-system interface is used to send commands and to receive the pneumatic sub-system data. A processor is connected to the input, the sensor interface and the pneumatic sub-system interface to control the supplied oxygen concentration on the basis of the required oxygen concentration, the measurement data and the state information. There are disclosed alternative versions of the automated system characterised by state information collecting media.

EFFECT: inventions provide the safe control of the supplied oxygen amount automatically.

27 cl, 5 dwg

FIELD: medicine.

SUBSTANCE: group of inventions refers to medicine. A method for facilitating expectoration on the basis of oscillation function, which generates an oscillating air flow in the pulmonary system is implemented by means of a device for facilitating expectoration. The above air flow contains an oscillating exhaled and oscillating inhaled air flows. A control unit of the above device comprises first and second identification units and detection units. The first identification unit is used to state if the pulmonary system has completed an inhale to control a valve to be closed to isolate the pulmonary system from the external environment. The second identification unit is used to state if an inner pressure in the pulmonary system is more than a pre-set pressure threshold. The detection unit is used to detect the beginning of the oscillating inhaled air flow to control the valve to be opened for the onset of coughing.

EFFECT: using the group of inventions enables more effective facilitating expectoration.

8 cl, 6 dwg

Laryngeal mask // 2543033

FIELD: medicine.

SUBSTANCE: in laryngeal mask, an O-ring cuff is formed by a U-shaped rim and a part of a large-port gastrodrainage of a special shape, inserting a gastric probe into which forms two auxiliary gaping passes for promoting the free discharge of gastric material or gas found close to an oesophageal funnel to the mouth cavity. The device can additionally comprise reinforcing components are used to avoid respiratory canal occlusion by patient's teeth. The declared laryngeal mask, except for the reinforcing components, represents a monolith and is formed by 1 cycle of injection-moulding machine operation that causes its absolutely low cost price.

EFFECT: laryngeal mask provides high patient's safety ensured by the effective discharge of the gastric material from a glottal aperture and demonstrate the practical simplicity of installation and good hermetism; it can be effectively used in clinical practice even in the patients with a risk of regurgitation and emergency patients.

5 cl, 5 dwg

FIELD: medicine.

SUBSTANCE: group of inventions refers to medicine. A lung compliance is measured in an individual who is at least partially self-ventilating. The quantitative measurement of the lung compliance can represent an assessment, a measurement and/or a rough measurement. The quantitative measurement of the lung compliance can be suspended over common methods and/or systems for the quantitative measurement of the self-ventilating individual's lung compliance; the lung compliance can be quantitatively measured relatively exactly without the use of a force measurement rope or any other external sensing device, which measures a diaphragm muscle pressure directly; the procedure does not require the individual to monitor the diaphragm muscle pressure manually.

EFFECT: quantitative measurement of the lung compliance can be used as an efficient instrument for the individual's health assessment, including detecting fluid retention associated with acute congestive cardiac failure.

15 cl, 4 dwg

FIELD: medicine.

SUBSTANCE: group of inventions refers to medicine. A lung compliance is measured in an individual who is at least partially self-ventilating. The quantitative measurement of the lung compliance can represent an assessment, a measurement and/or a rough measurement. The quantitative measurement of the lung compliance can be suspended over common methods and/or systems for the quantitative measurement of the self-ventilating individual's lung compliance; the lung compliance can be quantitatively measured relatively exactly without the use of a force measurement rope or any other external sensing device, which measures a diaphragm muscle pressure directly; the procedure does not require the individual to monitor the diaphragm muscle pressure manually.

EFFECT: quantitative measurement of the lung compliance can be used as an efficient instrument for the individual's health assessment, including detecting fluid retention associated with acute congestive cardiac failure.

15 cl, 5 dwg

FIELD: medical equipment, applicable for curative prophylaxis and for drug therapy of patients with bronchopulmonary diseases.

SUBSTANCE: the respiratory simulator consists of a mouthpiece - air conduit, casing with a cover, ball and a seat with a central hole making up a check valve. The check valve is made for closing at an expiration, its seat is made inside the casing in the form of a tapered recess in it and a central hole, by-pass channels are additionally made in the casing, a perforated diaphragm for limiting the ball motion is installed under the ball. The by-pass channels are made for adjustment of their area at an expiration or at an inhale, or simultaneously at an expiration and inhale and have a means for adjustment of the area of the by-pass channels. The means for adjustment of the area of the by-pass channels is made in the form of combined radial holes in the casing and ring and/or in the cover, and the cover and/or ring are made for restricted turning relative to the casing. The perforated diaphragm is made for tightening of the ball to the seat.

EFFECT: enhanced efficiency of treatment and simplified construction of the simulator.

14 cl, 16 dwg

FIELD: medicine, respiratory gymnastics.

SUBSTANCE: the present innovation deals with decreasing pulmonary ventilation in patient's endurable volume, controlling the rate for carbon dioxide (CO2) gain in expired air and maintaining the rate of its increase. Moreover, decreased pulmonary ventilation should be performed both at the state of rest and while doing physical loading, one should maintain the rate of CO2 gain in expired air being not above 2 mm mercury column/d at the state of rest and 11 mm mercury column in case physical loading to achieve the level of 32.1 mm mercury column at removing vivid symptoms of the disease and 55 mm mercury column in case of prolonged clinical remission. The method enables to improve therapy of hypocarbic diseases and states due to removing CO2 deficiency.

EFFECT: higher efficiency of therapy.

4 ex, 3 tbl

Air duct device // 2245725

FIELD: medical engineering.

SUBSTANCE: device has curved flexible air-conducting tube and mask segment. The mask segment is shaped to completely fit to the area above the laryngeal orifice. Supporting member has a set of thin flexible ribs branching out from core member stretching from opening area. Having the air duct device mounted, the flexible ribs thrust against the pharyngeal side of cricoid laryngeal cartilage immediately under the esophagus. The mask segment is fixed and thrusts against hard surface without injuring soft esophageal tissues. Versions of present invention differ in means for fixing around the laryngeal orifice of a patient.

EFFECT: enhanced effectiveness of lung ventilation in unconscious state.

14 cl,8 dwg

FIELD: medical engineering.

SUBSTANCE: device has chamber for accumulating carbon dioxide, bite-board and respiratory pipe. The chamber is manufactured as cylinder having conic bases arranged one in the other smoothly movable one relative to each other. The respiratory pipe with bite-board is available on one of external cylinder tips and single-acting valve with choker is available on the other tip allowing rotation for making resistance to expiration. Reservoir for collecting condensate is mounted on cylindrical surface the external cylinder. Pipe for taking air samples is available on distal external cylinder part cone base.

EFFECT: smoothly controlling expiration resistance and carbon dioxide concentration; enhanced effectiveness in separating air flows.

2 dwg, 1 tbl

FIELD: medicine; medical engineering.

SUBSTANCE: method involves applying diaphragmatic respiration with resistance to expiration. Overpressure equal to the resistance is created at inspiration stage. Breathing is carried out in usual pace in alternating A-type cycles as atmospheric air inspiration-expiration and B-type cycles as exhaled gas inspiration-expiration. Time proportion of breathing with exhaled gas to atmospheric air respiration is initially set not greater than 1. The value is gradually increased and respiration depth is reduced as organism adaptation to inhaled oxygen takes place, by increasing the number of B-type cycles and reducing the number of A-type cycles. Device has reservoir attached to mouth with individually selected expiration resistance. The reservoir has features for supporting gas overpressure at inspiration stage equal to one at expiration stage.

EFFECT: enhanced effectiveness of treatment; reduced volition effort required for training; improved operational functionality characteristics.

4 cl, 2 dwg

FIELD: medicine.

SUBSTANCE: method involves introducing catheter via nasal passage into the rhinopharynx and fixed above the entrance to larynx and artificial high frequency jet ventilation is carried out with frequency of 140-150 cycles per min in three stages. Compressed gas working pressure is increased at the first stage to 2.0-2.5 kg of force/cm2 during 7-10 min. The compressed gas working pressure is supported at this level to the moment the clinic manifestations of pulmonary edema being removed and gas exchange normalization being achieved at the second stage. The working pressure is stepwise dropped during 1-2 h at the third stage hold during 10-15 min at each step.

EFFECT: enhanced effectiveness in normalizing hemodynamics.

FIELD: medical equipment.

SUBSTANCE: apparatus for artificial ventilation of lungs and inhalation narcosis can be used for emergency service and has unit for artificial ventilation of lungs, anesthetic unit and unit for alarm switch of anesthetic. Unit for artificial ventilation of lungs has oxygen discharge changing unit, flow meter, pneumatic pulse oscillator, nonreversible pneumatic valve which has access to patient's mask. Anesthetic unit has gas relation changing unit and mixer which has access to patient's mask. Unit for alarm switching anesthetic off is made is made in form of comparison unit which has pneumatic valve mounted in anesthetic feed line, two pneumatic relays and two regulators. Apparatus provides improvement in sensitivity to reduction in oxygen pressure in gas mixture.

EFFECT: widened operational capabilities; simplified exploitation; improved safety.

2 dwg

FIELD: medicine, anesthesiology, resuscitation.

SUBSTANCE: under conditions of artificial pulmonary ventilation at positive pressure at the end of expiration one should set the level of positive pressure at the end of expiration being above against pre-chosen optimal one for 4-8 cm water column. About 10-15 min later one should introduce perfluorocarbon as aerosol with the help of nebulizer for 10-15 min. The innovation enables to introduce perfluorocarbons without depressurization of respiratory contour, decreases damaging impact upon pulmonary parenchyma and, also, reduce invasiveness of the method and decrease expenses of perfluorocarbons.

EFFECT: higher efficiency of therapy.

1 ex

FIELD: medicine.

SUBSTANCE: method involves administering one of antyhypoxidant-antioxidant medicaments on empty stomach in age-specific dose before exposing a patient to cyclic treatment with gas medium. Hypoxi-hypercapnic gas mixture is applied as respiratory gas medium. Then, the patient is moved up for breathing with air-oxygen mixture. TcPO2 and/or SO2 restoration period being over, repeated hypoxi-hypercapnic treatment cycle is applied. The mentioned patient treatment cycles are applied in succession 4-10 times.

EFFECT: enhanced effectiveness of treatment; increased adaptation and reduced risk of side effects.

3 cl, 1 tbl

FIELD: medicine, in particular, exercising of respiratory organs in moderate hypoxia and hypercapnia mode with adjustable resistance to inhalation and expiration.

SUBSTANCE: respiratory exerciser has cylindrical mixing chamber with narrowed upper part, respiratory pipe connected to cylindrical mixing chamber, and bottom with perforations provided in its peripheral portion. Bottom of cylindrical chamber is made doubled. Members of porous material having predetermined density are located within bottom cavity. Central part of bottom is equipped with channel provided within cylindrical chamber and communicating with atmosphere. Inhalation indicator provided within channel is made in the form of movable piston member. Respiratory pipe is equipped with acoustic expiration indicator made in the form of unidirectional resonance whistle. Bottom inner cavity may be provided with additional replaceable loading inserts formed as film disks with openings having predetermined area and flexible loop attached to upper part of cylindrical chamber and having adjustable length.

EFFECT: reduced restrictions in orientation and fixing of exerciser position during usage and provision for indicating quality of expiration cycle.

3 cl, 2 dwg

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