Mucosal tissue dressing and method for using it
SUBSTANCE: what is presented is a boric coating containing a barrier material and an adhesive material. The barrier material and adhesive material are applicable for combined or sequential postoperative application on the mucosal tissue. Such application provides a multilayer film dressing containing a layer of the above barrier material and a layer of the above adhesive material contacting with the barrier material and mucosal tissue. The dressing is left unmoved in place for 48 hours after the postoperative application of the multilayer film on the mucosal tissue. The dressing is absorbed for 14 days. The multilayer film dressing has an external rim surrounding a tonsil bed and a concave centre shaped after the tonsil bed.
EFFECT: reducing or eliminating pain sensations following the mucosal operations, including tonsilectomy, adenoidectomy or other pharyngeal operations.
19 cl, 17 dwg, 3 ex
CROSS-REFERENCE TO RELATED INVENTIONS
This application claims the benefit of provisional patent application U.S. No. 61/017976 of December 31, 2007 and provisional application for U.S. patent No. 61/052413 from may 12, 2008, both of which are incorporated herein by reference.
BACKGROUND of INVENTION
Tonsillectomy and adenoidectomy - the two most common types of surgical interventions in children. As tonsillectomy and adenoidectomy is associated with significant postoperative pain, which can last up to two weeks. Due to post-operative pain, worse when you try to swallow food, children usually can't eat solid food for at least two days, and often within six days after the operation. In addition to postoperative pain in children after tonsillectomy/adenoidectomy also often observed postoperative bleeding, nausea and/or bad breath. Although tonsillectomy and adenoidectomy adults are significantly less, these operations cause they have the same post-operative pain and discomfort.
Usually the result of surgery on the mucosa, such as tonsillectomy and adenoidectomy, in the postoperative period there are several problems. Mucous tissue, as a rule, full-time is sensitive, and it's hard to put a bandage. Usually for a speedy healing and the realization of its intended functions mucous tissue must remain moist. Damaged mucosa tissue creates considerable discomfort for the patient.
In an attempt to minimize pain and discomfort caused by surgery, it was developed a number of methods for performing tonsillectomy and adenoidectomy. Performing tonsillectomy method kobiecie was developed by the company Arthrocare Corporation (Austin, Texas) and is less invasive, and therefore, is less painful. However, even tonsillectomy method kobiecie or other minimally invasive methods do not allow to completely avoid the expressed pain and bleeding in the postoperative period in children and in adult patients, which in turn does not allow them to take solid food for several days after surgery. Up to the present time has not developed a satisfactory means for post-operative treatment, which could alleviate the pain and allow the patient to freely eat after tonsillectomy and adenoidectomy.
Thus, there is a need in the tool post-operative treatment, which would be able to help children and adult patients who days before to recover after tonsillectomy and adenoidectomy. Ideally, such a tool should act as a barrier to protect mucous tissue at the site of surgical intervention, and around him, able to relieve the patient's process of swallowing and make it less painful. Optimal barrier should fit snugly to the mucous tissue, even when abrasive action of swallowing and, in addition to the effect of easing pain, should also reduce bleeding. At least some of these problems can be solved by various embodiments of the present invention.
In addition to therapeutic agents used after tonsillectomy/adenoidectomy, there are many other tools that can be used in the ear, nose, throat or mouth or in combination with armband for mucosal tissue. For example, you want the bandage to the mucous tissue, which would fit snugly inside the tissue and to deliver one or more drugs to a desired region in the ear, nose, throat or mouth. An additional advantage of this dressing would be the ability to stop the leakage of cerebrospinal fluid, to reduce blood loss at the site of excision, and the bandage acts as a cushion or support for the pieces of fabric and/or the like. In any of these contexts, the task of creating headbands for mucosal tissue similar szalacha, condition of which is that the bandage should remain in place and act long enough, it does not prevent the normal physiological functions. Various embodiments of the present invention meet at least some of the presented requirements and can be used not only as bandages after tonsillectomy/adenoidectomy.
SUMMARY of INVENTION
Certain embodiments of the present invention provide a method of reducing or eliminating pain after operations on the mucous membrane, including after tonsillectomy, adenoidectomy or other pharyngealised operations.
Certain embodiments of the present invention provide absorbable film or coating that serves as a mechanical barrier and reduce pain that may be caused, for example, friction between pieces of solid food and healing tissue during the first few days after surgery.
Some of the options for implementation may include one or more medicinal substances for local alleviate pain, promote healing and/or affecting the mucous in the bed of the tonsils or near any other way. In some embodiments, the implementation of the multi-layer bandage may contain the hypoxia medicinal substance. Some embodiments of allow the doctor to enter or cause otherwise one or more medicinal substances on the bandage before applying this bandage to the patient.
In some embodiments, the implementation of the bandage may be applied not only to the bed of the tonsils, but also to other areas and be used not only to relieve pain and eliminate pain after tonsillectomy, but also for other purposes. For example, in some embodiments, the implementation of the bandage may be applied to the nasal septum to facilitate or improve the quality of plastics nasal septum. In various embodiments, the implementation of the bandage can be applied at different sites in the nasal and paranasal cavities, paranasal sinuses, polyps located in the nasal or paranasal cavities, Evstafieva the tube in the oral cavity or the like, for performing various functions. For example, the bandage can be used as a means of drug delivery. In some embodiments, the implementation of the bandage can be used for rigid bracing or strengthening soft tissue, for example, in the treatment of sleep apnea. In other embodiments, implementation of the bandage can be used for closing or plugging the leakage of cerebrospinal fluid (CSF). In yet another embodiment, the bandage m which can be used as a lining for iontophoresis, through which an electric current. These and other embodiments of described hereinafter with reference to the accompanying drawings.
BRIEF DESCRIPTION of FIGURES
Figure 1 presents an image of the bandage in the future in accordance with one embodiments of the present invention.
Figure 2 presents an image of two layers of bandages in the future in accordance with one embodiments of the present invention.
Figure 3 presents the image of a multi-layer bandages in the future in accordance with one embodiments of the present invention.
4 shows the image bandage alternative forms in the future in accordance with one embodiments of the present invention.
Figure 5 presents a perspective image headbands cylindrical form, intended for use in Evstafieva pipe or around it in accordance with one embodiments of the present invention.
Figure 6 illustrates the method of preparing bandages for use in accordance with one embodiments of the present invention.
7 illustrates a method of packaging and preparation of multilayer bandages for use in accordance with one embodiments of the present invention.
On figa and 8B p is illyustrirovany packaging bandages for use in accordance with one embodiments of the present invention.
Figure 9 illustrates a method of packaging a bandage for use in accordance with one embodiments of the present invention.
Figure 10 shows a device and method for local (in situ) the bandage in accordance with one embodiments of the present invention.
On figa shows a device and method for local (in situ) dressing; figv presents a large-scale view of part of the device and method in accordance with one embodiments of the present invention.
On Fig illustrated by way of the bandage after tonsillectomy in accordance with one embodiments of the present invention.
On Fig illustrated by way of local (in situ) the bandage after tonsillectomy in accordance with one embodiments of the present invention.
On Fig illustrates the method of applying the film on the nasal septum in accordance with one embodiments of the present invention.
On Fig illustrated by way of the bandage on the back of the tongue for the treatment of sleep apnea, in accordance with one embodiments of the present invention.
On Fig illustrates the method of testing the adhesion strength.
On Fig p is illustrious test method adhesion peel.
DETAILED description of the INVENTION
Various embodiments of the present invention, in General, represent armband for mucosal tissue that is applied on it. In some cases, the bandage can be applied after surgical excision of tissue, such as tonsillectomy and adenoidectomy, in other cases, the bandage can be applied to the fabric, which was not applied surgical intervention. In various embodiments, the implementation of the bandage may have a number of suitable configurations, some of which are described next. The dressing may also contain one or more drugs, which she can deliver to the tissue on which it is overlaid, and/or to surrounding tissues.
Certain embodiments of the present invention contribute to the mitigation of pain in the postoperative period associated with surgery performed on the mucous tissue or near it. In a preferred embodiment, the bandages are manufactured and used in accordance with certain variants of implementation of the present invention must perform some or all functions described below, and to have some or all of the following properties:
The bandage can be quickly and easily applied during surgery, immediately after surgery on the spot.
ovaska can be easily adapted for use after performing such medical or surgical manipulation, as tonsillectomy or adenoidectomy.
Bandage forms a mechanical barrier, sufficient to protect healing tissue from the friction, for example, ingestion of solid food.
The bandage has sufficient elasticity both dry and wet condition. The bandage can easily be adapted to the complex surface shapes.
The armband contains a hydrated membrane is not exposed to excessive swelling and preserving the elasticity and flexibility after bonding to the fabric.
The armband contains a film that quickly is applied and/or attached to a damp cloth and when wet remains solid and non-sticky.
The bandage is fixed in the surgical bed for a period of from 12 hours to 5 days.
The bandage should remain in place untouched for at least 48 hours.
The bandage is completely absorbed after 10-14 days.
The bandage does not swell, does not form an obstacle and does not cause discomfort.
The bandage begins to dissolve slowly without the risk of release of large pieces of material, which can cause choking or other complications.
The bandage does not hinder the healing process, and in some embodiments, the implementation can speed up the healing process.
Options for use in the oral cavity does not have an unpleasant taste. In some embodiments, application of dressings can the be even flavored.
The armband provides a sense of coolness.
The armband is made from inexpensive materials.
Embodiments of the present invention described herein may have some or all of these properties and to perform some or all of these functions.
Certain embodiments of the present invention are applied to a surgical bed as a bandage or dressing. The bandage can be made in accordance with a predetermined form and/or cut according to the size and shape defined by the customer. Options for implementation in the form of a bandage can be removed liner, which when removed reveals the adhesive layer to the fabric. The bandage can serve as a platform used to deliver drugs or to release other drugs.
In General, the bandage to the mucous tissue can perform adhesive, barrier, mechanical and/or solvent functions in different variants of implementation. In many embodiments, the implementation of the bandage fabric performs a local function, which is to alleviate pain and eliminate discomfort, reduced bleeding, reduced leakage of CSF and/or the like In some embodiments, the implementation of the bandage may alternatively or additionally perform the Central function that zaklyuche is camping in the delivery of drugs into the bloodstream or Central nervous system. In various embodiments, the implementation of the bandage can serve as a platform for the delivery of drugs with various respiratory diseases and/or diseases of ear, throat, nose (ENT diseases or pathological conditions and can be applied to the mucosal surface. In another embodiment, for example, the bandage can be used as protivoptichego barrier in the nasal cavity or paranasal sinuses to prevent fusion of the tissue after the surgery as the result of iatrogenic damage. In another embodiment, the bandage can be used on surfaces that are part of recurrent polyps, to prevent relapse as a result of mechanical impact, and due to the continuous delivery of a drug.
Figure 1 shows the perspective representation of one of the embodiments of the present invention. Bandage 100 has an adhesive surface 110 and the barrier surface 120. Adhesive surface 110 is designed for contacting and bonding to tissue, such as mucosal tissue or mucous membranes. Adhesive surface 110 may have a structure that provides adhesion to the tissue. Adhesive surface 110 may have a fibrous, porous, ribbed, grooved, or any other structure including the combined structure. The texture of the adhesive surface can be selected so as to accelerate the healing process and to facilitate the removal of the bandage 100 in certain embodiments of the implementation, where the removal is part of the treatment.
Referring to figure 1, the barrier surface 120 is designed to provide resistance to mechanical stress, for example, friction. Barrier surface 120 may also provide resistance to infiltration and penetration of substances from biological environment the place the bandage. Barrier surface 120 may be slippery to prevent adhesion of foreign particles, for example, food. Barrier surface 120 may have a texture, such as described for the adhesive surface 110 or other. The texture of the barrier surface may be selected so as to prevent sticking of materials to the bandage 100. As the texture of the barrier surface, and the texture of the adhesive surface can be selected so as to facilitate the resorption of the bandage 100 in certain embodiments of the implementation, where resorption armband is a part of treatment method.
Figure 2 presents a perspective depiction of one possible implementation of the present invention. The bandage 200 has an adhesive layer for tissue 210 and the barrier layer 220. The adhesive for fabric 210 structured is an thus, to improve adhesion to the tissue. For example, the adhesive for fabric 210 may have a porous structure, which allows better penetration of the fabric layer. In General, the contact high specific surface between two surfaces improves adhesion. Any structure that increases the contact surface area between the surgical bed and the adhesive layer 210 suitable for use.
Again refer to figure 2, an adhesive layer for fabric 210 may have a structure that allows them to adapt to the dissolution rate. Some materials, such as polyanhydride, dissolve, since the outer cover. Other materials, for example, poly(α-complex hydroxyether), dissolve, since the internal structure. As for surface-erosive and structural-erosive materials control surface area can affect the rate of dissolution. The preferred structure for the adhesive layer 210 can balance the requirements of the surface area for adhesion with the requirements for dissolution. Also, as described in detail below, the surface area can affect the profile of drug delivery dressings. The preferred structure for the adhesive layer 210 also take into account the factor of drug delivery.
Regarding figure 2, the adhesive layer fabric 210 includes SEB the adhesive surface 215, which is designed for contacting and sticking to the fabric. Adhesive surface 215 may be teksturirovanie, as described above in the commentary to 1.
Regarding figure 2, the barrier layer 220 may be structured in such a way as to improve mechanical strength and resistance to infiltration. Based on the fact that bandage certain embodiments of the present invention can be elastic, the barrier layer 220 may have a structure that provides flexibility and durability, allowing the natural tissues of the body to move if swallowed, making it possible to avoid damage during the passage of solid food. As the adhesive for fabric 210, the barrier layer may have a structure that allows them to adapt to the dissolution rate. The barrier layer 220 may be made of surface-erosive or structural-erosive material or a combination of these materials. Thus, the preferred structure for the barrier layer 220 can match the strength requirements for mechanical durability requirements of solubility. As the barrier layer 220 may also act as a reservoir for drug delivery, the preferred structure for the barrier layer 220 may factor the x delivery.
Regarding figure 2, the barrier layer 220 includes a barrier surface 225, which is designed to provide resistance to penetration by mechanical force, foreign bodies or bacteria, and infiltration components of the tissue. The barrier layer 220 and/or barrier surface 225 may have shock absorbing properties. Barrier surface 225 may have a texture, as described above in the commentary to 1.
The total thickness of the bandage may vary from 0.1 mm to 0.7 mm, the Preferred thickness of certain embodiments about 0.3 mm, the thickness of the adhesive layer may be approximately 0.1 mm and the thickness of the barrier layer is about 0.2 mm In certain embodiments of the implementation of the thickness of the bandage may be uneven. For example, in certain embodiments of the implementation of the border can be thinner than the Central portion of the bandage.
Figure 3 presents a perspective depiction of one possible implementation of the present invention. Bandage 300 consists of an adhesive layer 310 and the barrier layer 330. The connecting layer 320 connects the adhesive for fabric 310 and the barrier layer 330. The connecting layer 320 may have a structure in accordance with the above description for the adhesive and barrier layers for fabric. Thus, the connecting layer 320 can have is the structure, which is adapted to receive a certain rate of dissolution. Further, the connecting layer 320 may act as a reservoir for drug delivery. The preferred structure for the connecting layer 320 is specially selected to provide the desired dissolution rate and rate of drug delivery.
Regarding figure 3, the adhesive layer fabric 310 and the barrier layer 330 (each of them) may have a structure as described in the comments to figure 2. In certain embodiments of the exercise, in which the adhesive for fabric 310 is structured in such a way as to ensure the ability of adhesion and barrier layer 330 is structured in such a way as to provide mechanical durability, the connecting layer 320 may be structured so as to ensure reliable communication between the two layers. Thus, the structure of the adhesive layer 310 may be, for example, highly porous, whereas the structure of the barrier layer 330 may be, for example, tightly linked. The connecting layer 320 may provide structural gradient between these two different structures to create a reliable connection between the layers.
Figure 3 shows a three-layer dressing. Headbands certain embodiments of the present invention can consist of more che the three layers. The adhesive for tissue specific embodiments may consist of several layers, which may be the same or different structure. Each layer in the composition of the adhesive layer may have a structure that allows you to obtain specific properties. Similarly, the connecting layer and the barrier layer can be formed of multiple layers having the same or different structure and composition. In certain embodiments implement one or more layers of bandages can be painted in order to facilitate the use and/or identification of different layers. In some embodiments, the implementation part of the bandage or dressing a whole can be painted in order to assist the physician and/or patient to make sure that the bandage is still in place, what part of the bandage dissolved, etc.
In a number of embodiments, one or more bandages for mucosal tissue may have a configuration that allows it to retain and allocate one or more drugs or other substances. For example, steroids, anesthetics, anti-inflammatory drugs, mucolytics, antibiotics and many other substances can be introduced into the layer of bandages to the mucous tissue so as to ensure the selection of these substances from the bandage to the desired speed after dressing natcan. Many diseases are localized in specific parts of the body, and the effectiveness of the treatment depends on the directed therapeutic effects on the affected area. Local delivery, provide a bandage that produce medicinal substances can afford to increase their therapeutic concentration where it is needed, and can also prevent many unwanted systemic side effects.
Directed therapeutic effect in diseases of the gastrointestinal tract, usually hampered by the mucosal surface, which cannot be processed using conventional dressings, and because of the constant flow of gastric juices that break down and wash away mucoadhesive means of drug delivery. Various embodiments of the present invention may include mucoadhesive film that can be used to deliver drugs, and the barrier layer, which allows for prolonged delivery of drugs.
A list of some diseases of the gastrointestinal tract, for which treatment can be effectively applied this method of drug delivery:
Disease or treatment of the oral cavity, for example, oral candidiasis (oral thrush), xerostomia (dry mouth), on reoperation pain and infection, oral cancer, halitosis, shipping fluoride compounds, the softening of the gums during orthodontic procedures, etc.
Disease or treatment of the throat, such as tonsillitis or post-operative care after tonsillectomy or other operations, the treatment of dysfunction of the vocal cords, for example, paralysis or polyps, cancer of the larynx, etc.
Disease or treatment of gastrointestinal tract, such as gastric ulcer, gastritis, reflux, cancer, infections caused byHelicobacter pyloridysfunction proton pump, obesity, etc.
In various embodiments, the implementation of the drug may be injected into the dressing during production or during use. The bandage can be biodegradable or non-degradable and removed as needed. One film may be incorporated one or more drugs that can be delivered on the same or on different circuits release. The bandage may be applied manually or using endoscopic instruments. The bandage can be designed to release drugs in the direction of the mucosal surface and in the direction of the mouth/throat/stomach-intestinal tract.
Delivery of drugs to slimy surfaces is difficult due to the absence of binders, which Moutafchiev contact with this fabric and held in place with sufficient time for delivery of therapy within the required period. Developed a large number of dressings for the oral cavity, for example, the patch SaliCept Oral Patch company Carrington Laboratories and Gelclair gel Oral gel company Sinclair Pharmaceuticals. These materials adhere to the mucosa of the oral cavity, but they dissolve within minutes and may not be used for prolonged drug delivery.
In various embodiments, implementation armband for mucous within the framework of the present invention can fit snugly to mucous surfaces and remain in place during the period from several days to several weeks. In some embodiments, the implementation of the bandage can be placed directly over the site of the gastrointestinal tract affected by plague, or directly over the lesion and can provide prolonged continuous delivery of drug substances to the affected area. In some embodiments, the implementation of the bandage to the mucous membrane may be placed endoscopically directly in the gastrointestinal tract.
If the dressing material is non-degradable, if necessary, the system of drug delivery can be removed, and the delivery of drugs interrupted. The bandage may include a barrier layer which prevents the dissolution of the material under the action of acid is contained in the gastrointestinal tract. Similarly, the barrier layer may prevent the bandage from interaction with food, essential nutrients or drugs that fall into the gastrointestinal tract by oral administration.
In some embodiments, the implementation of the medicinal substance can be designed to pass through the blood-brain barrier (BBB) penetration into the Central nervous system (CNS). The most important factor hindering the development of new drugs for the treatment of diseases of the Central nervous system, is GEB, which restricts the penetration of most potential drugs in the CNS. The only place where the BBB does not limit the penetration, is located on the inner surface between nazalnam epithelium and the brain. Upon delivery from the surface of the nasal epithelium concentration of the medicinal substance in the Central nervous system may exceed the concentration in the systemic plasma. Shipping from the nasal cavity to the CNS also occurs along the conduction paths of the bodies of the olfactory and the trigeminal nerve and in addition affects the lymphatic tissue associated with the nasal cavity and deep cervical lymph nodes. Thus, the delivery of drugs through the nasal mucosa may be the only way directed delivery of drugs to the Central nervous system and lymph nodes.>
Among diseases of the Central nervous system, which can affect by intranasal drugs released from the bandage to the mucous tissue of the present invention include Alzheimer's disease, Parkinson's disease, brain cancer, stroke, migraine, psychosis, epilepsy, meningitis, memory loss and other forms of neurodegenerative diseases, lymphoma, neurospin, various addictions, certain forms of obesity and other Dosage forms can include, for example, nasal sprays and mucoadhesive micro-emulsions, some of which may be developed in the future.
The bandage described in the present invention, in some embodiments, the implementation can be used to provide localized and controlled drug delivery selectively to the Central nervous system. The medicinal substance can be encapsulated in a bandage during its manufacture, or it can be added at the time of placing the bandage in the nasal cavity or on the mucous membranes of the paranasal sinuses. If necessary in some embodiments to implement the present invention additional drug substance may be added later. The bandage can be biodegradable and completely disappear so that its removal is not necessary, or it may be non-degradable; if necessary, the e can be removed for replacement or for discontinuation of treatment.
Delivery of medicinal substance to be delivered from headbands to mucosal tissue, is carried out in a targeted and localized in the place of the bandage and can be directed down into the mucous tissue, but not in the respiratory tract. Not all drugs can be made in the form of an aerosol, and dosage form, usually require the addition of auxiliary substances, potentially adverse impact especially on the mucous tissue. In the case of naselenie sprays will probably need re-introduction of sufficiently high doses to achieve therapeutic dose at site-target and for maintaining the doses within therapeutic range in the interval between administration of the drug. In contrast bandage for mucosal tissue can deliver a medicinal substance with a constant or controlled rate continuously up until you need it. In General, this allows for delivery of small doses and does not cause vibrations "from maximum to minimum concentration of drug substance over time. In some embodiments, the implementation of a reservoir for medicinal substance can be added later as needed for continuous therapy or can be removed if you need to quickly stop the treatment. Now in the process of developing the processing are new films for drug delivery, which will allow you to deliver several drugs simultaneously, but at different speeds, based on the pharmacokinetic profile of these substances.
In some embodiments, the implementation of the bandage, delivering a medicinal substance can be used for a preliminary assessment of the effectiveness of medicinal substance in the treatment of pathological conditions of the CNS before more invasive method of drug delivery. Thus, it becomes possible to test various candidate drugs on the potential efficacy of the patient before the patient will be subjected to dangerous surgery.
Previous explanations illuminate certain features, characteristics and/or properties of the dressing to the mucous tissues. Many of these properties can be used in some specific embodiments, the implementation described below.
4 shows an alternative implementation of the bandage 40 curved shape corresponding to the shape of the bed tonsils after tonsillectomy. The bandage 40 has an outer rim 42 that is configured to be placed on the surface normal, neoperabelnoy tissue surrounding the bed of the tonsils, and a concave Central portion 44 corresponding in shape box tonsils. The outer rim is to 42 may have the same thickness, as the Central part 44, or the outer rim 42 may be thinner than the Central part 44. In some embodiments, the external rim 42 may be thicker than the Central part 44. The outer rim 42 helps the bandage 40 to remain in place, providing increased surface contact with healthy tissue.
Regarding figure 4 bandage 40 may have various shapes and sizes, allowing you to adapt it for use in different patients and/or surgical boxes of various sizes. Headbands 40 can be produced in a variety of predetermined shapes and sizes. For example, the bandage 40 may have a large size range of the Central part 44, which can vary the depth, diameter and/or radius of the bend. Similarly, the outer rim 42 may have different diameters. The doctor may choose a bandage appropriate size and shape to overlay after surgery. In an alternative embodiment, the physician may give the bandage 40 form individually for surgical bed of the patient. In another alternative embodiment, the physician may combine the outer rim 42 of the specific size and shape with the Central part 44 of specific shape and size in order to create a special bandage that meets the needs of the particular patient.
Relative to figure 4 of the outer rim 42 and the Central portion 44 can be made is of a single material, and of different materials. Materials and/or textures of the outer rim 42 can be selected to minimize irritation or damage to healthy tissue, is placed on the outer rim. Materials and/or textures of the Central part 44 can be selected in such a way as to accelerate the healing process of the surgical bed. The Central region 44 and/or the outer rim 42 may also contain a drug or other substance.
Figure 5 shows an alternative implementation of the bandage 50, where the bandage has a cylindrical shape. Cylindrical bandage 50 can also be used directly in the cylindrical cavities of the body or near them, for example, in Evstafieva pipe. The fluid in the Eustachian tubes is the most common problem, and headbands with certain characteristics, can be successfully applied in the Eustachian tubes in therapeutic purposes. For example, a cylindrical bandage 50 may be placed at the base Evstafieva pipe and can deliver one or more drugs, such as steroids or surfactants. Cylindrical bandage 50 can serve as a check valve for the outflow of liquid from Evstafieva pipe, preventing the ingress of liquid into it. Cylindrical bandage 50 can be used for fluid absorption or it may perform com is Inacio these or other functions. The choice of materials, patterns and textures for the walls of the cylindrical bandages 50 may affect the functions and properties of the bandage, as described in this document.
Figure 6 shows a variant implementation of the present invention, where the bandage adapted for use in the surgical bed. The bandage 400 has a barrier surface 410 and an additional liner 420. In certain embodiments of the implementation of the present invention, the bandage may have a liner covering the adhesive surface, the barrier surface or both surfaces. In the embodiment depicted in Fig.6, the liner 420 covers the adhesive surface (not numbered) of the bandage 400. As shown, the liner 420 has an additional tab to ensure that the liner can be removed easily. The liner serves to preserve the integrity of the adhesive surface or barrier surface prior to use. The liner prevents premature release of substances from the bandages.
Regarding 6 scissors 450 can be used to cut bandages 400 desired shape corresponding to the shape of the surgical bed. The bandage 400 may be produced in a predetermined configuration, for example, in the shape of a butterfly, flower-shape, triangular, or any other standard forms. The bandage 400 may also have a curved F. the RMU or any other form, protruding beyond the edges of the standard dressing. In addition, the bandage 400 may be plastic in order after some manipulations, the bandage 400 may maintain a desired shape. The materials selected for adhesion, barrier and patch (if any) of layers, can provide plastic properties of the dressing.
In certain embodiments of the implementation of the present invention is applied an adhesive material to cover and protect the surgical bed from friction in contact with food or other items. As the adhesive material can be applied polymer. The material is applied by spraying, rubbing, staining, or other way. Surgical bed is protected from mechanical damage or irritation. In addition, the barrier can protect the surgical bed against the penetration of pathogenic microorganisms or other malware infiltrates. The bandage can serve as a platform for drug delivery or release of other therapeutic agents.
Figure 7 presents a fabric bandage 70 and the way of its packaging. In this embodiment, the bandage 70 includes a tissue adhesive for fabric 71, which has one or more holes 72. Bandage 70 may also include an absorbent layer 73 and the barrier layer 74. The adhesive for fabric 71 has an external surface shall knost, having the ability to stick to the mucosal tissue, and the inner surface, having the ability to stick to the absorbent layer 73. The adhesive for fabric 71 is made of materials suitable for these purposes in accordance with the description presented here. The absorbent layer 73 is designed to absorb therapeutic or other agents before dressing on the surgical bed and allows these agents eluted over time. The absorbent layer 73 may have a porous structure (including macroporous, microporous and nanoporous structure) to facilitate the uptake and release agents. Certain materials unlike other materials may be preferred for use in combination with specific agents. For example, the hydrogel material may provide a suitable profile release for hydrophilic agent, whereas more hydrophobic material may provide a suitable profile release for hydrophobic agent. The barrier layer 74 can serve as a structural support for the absorbent layer 73, increase resistance to mechanical friction on the outer surface of the bandage 70, if it is applied on the surgical bed, and to serve as a barrier to the elution agent, as agent, in a preferred variant is NTE, eluted through an adhesive layer for fabric 71 (and/or through the openings 72).
Relative to Fig. 7, although all the bandage can be Packed together, in certain embodiments of the exercise of the adhesive layer fabric 71 may be Packed separately from the absorbent layer 73 and/or the barrier layer 74. In certain embodiments of the implementation, in particular, in those embodiments of the implementation, where the adhesive for fabric 71 packaged separately, the doctor may add a drug or other substance in the absorbent layer 73 and then apply the adhesive to the fabric 71 on the absorbent layer 73. Thus, individual packaging adhesive layer 71, you can choose the necessary medicinal substance, and also to adapt the dosage of this substance for a specific occasion. Drugs and other substances can be added in any suitable way, for example, by injection using a syringe, pouring from a container, spraying, etc. In alternative embodiments, the implementation of all three layers 71, 73, 74 can be separated from each other and connected by a doctor or other user. In some embodiments, implementation of the various absorbent layers 73 may be pre-packaged and contain various medicinal or other substances, thus, the physician can choose the absorbent layer 73 depending on n the needs of the specific patient. In alternative embodiments, the barrier layer 74 may be Packed separately from the adhesive layer absorbent layers 71 and 73.
In some embodiments, the implementation of whatever layer is not used, it can serve as a sealing layer for absorbing layer 73, which are injected any drugs or other substances. This seal may allow the bandage 70 to act as a fill tank, which aluinum substance over time. As noted above, the layer which is superimposed on the other layers and which comprises a substance that can be adhesive layer 71, a barrier layer 74 or even any other layer in alternatives implementation. In some embodiments, the implementation of the sealing layer may be impermeable so that the added drug or other substance (substances) must be released, passing through different layers or through one or more holes in the layer. Alternatively, the sealing layer may be permeable or semi-permeable to initially sealing contain a substance, and then over time to allow him to escape.
On figa and 8B presents alternative ways of wrapping bandages for use in accordance with certain variants of implementation. Relatively figa, multilayer fabric bandage may be arranged in a stack 80, fastened along the edge of the stack 81. The user at a time can take one fabric bandage from the stack 80 for use. Similarly, referring to figv, multilayer fabric bandages can be stored in the dispenser 85 and retrieved from it through the hole, the slit 86.
Figure 9 presents another way of packing cloth bandages for use in accordance with certain variants of implementation. Dispenser 90 includes a roll 91 fabric bandages, which can be removed and cut off the bandage the required length using a cutting edge 92. The doctor can choose the right size fabric bandage roll 91.
Figure 10 shows a variant implementation of the present invention, where the bandage is formed and superimposedin situon the surgical bed. The device 500 includes a reservoir 510, item elongated 520 and the distal end 530. The reservoir 510 contains at least one material suitable for delivery form, for example, in the form of liquid or gel. Reservoir 510 may be a cylinder of a syringe or similar device. The reservoir 510 is connected to the part elongated 520. Item elongated 520 has at least one lumen through which material contained in the reservoir 510. Item elongated 520 which may be flexible, hard or combination. The necessary flexibility or rigidity details elongated 520 depends in part on the affected area to be treated. For example, the affected area in a remote lumen of the body requires the use of flexible parts elongated, capable of providing access through tortuous anatomy.
Relative to figure 10, the material from the reservoir 510 passing through the item elongated 520, is applied to the affected area through the distal end 530. The transverse size of the distal end 530 corresponds approximately to the transverse size of the lumen details elongated 520. In an alternative embodiment, the distal end 530 may shrink or expand, thus, its dimensions are different from the size of the clearance items elongated 520. Also, the distal end 530 may have a configuration that enables the specific shape of the jet. For example, the distal end 530 may be made in the form of a cap with holes. Figure 10 the shape of the jet 550 is used to form layer 540.
Also, the distal end 530 may be plastic, so the user can pre-set the angle that the distal end 530 forms with item elongated 520 to send the application material. The distal end 530 may be adjustable, allowing the user to control e.g. the pressure spray after as the device reaches the affected area.
The distal end 530 allows you to apply the material in the form of a jet 550, and also allows you to apply the material in any way that can be applied liquid, gel or other material. For example, the liquid or gel may leak, drip, or a slow leak from the distal end 530. Among the devices that are suitable for the deposition of material, known as needles, cannulas and catheters. Can also be used, and other devices suitable for applying or rubbing of the material on the surgical bed, for example, the tampon.
In one embodiment, spray or liquid dressings can be applied not only in the surgical bed after tonsillectomy/adenoidectomy, but also on other sites. Materials bandages used on other sites, can have properties or characteristics that are different from the properties or characteristics of the dressings applied after tonsillectomy/adenoidectomy, in order to perform the functions required in such areas. For example, liquid bandage can be applied to the operation of mucosal tissue to reduce bleeding and discharge after surgery. In another embodiment, the sprayed material may be used within a paranasal sinus to reduce or stop ciliary movement and such about what atom, for protection of medicinal substance, delivered in his bosom, from bias or from draining out sinuses in the atrial activity. Spray or liquid bandage can be used to prevent the leakage of CSF as a solid film.
On figa and 11B presents another variant of implementation of the present invention, in which the bandage is formed and superimposedin situon the surgical bed with the help of energy source. The distal portion of the device 600 includes a tubular piece elongated 620 and the elongated conductor 630. The tubular piece elongated 620 similar to the item elongated 520 so that it can be connected to the tank and used for feeding and applying material to the affected area requiring treatment. The elongated conductor 630 is shown in connection with a tubular piece elongated 620, although in certain embodiments of the implementation of the elongated conductor may be a separate device. The elongated conductor 630 is capable of conducting energy, such as ultraviolet radiation, visible radiation, infrared radiation, radio frequency energy sound waves (including ultrasonic), heat and other energy forms or their combinations. The elongated conductor 630 can also be used to ensure the Oia vacuum or air flow through the bandage to accelerate drying, structuring or adhesion of the material. The elongated conductor 630 has a distal conductive end 650, which can be used to focus or to focus the energy conducted through the conductor elongated 630. As the distal conductive end 650 may be used, for example, a lens. The energy held by the elongated conductor 630 is used for structuring material applied on the affected area, and the formation of the layer, for example, a layer of bandages 660.
Relatively figv layer bandage 660 is formed from a liquid, gel or other material applied on the affected area. In certain embodiments of the implementation of the deposited materials can be transformed from one state to another, such as from liquid to gel, from liquid to solid state, from the gel to the solid state, or any other combination thereof. Such transformation can be defined as "structuring"; they include traditionally known gelation, curing, polymerization and processes equivalent to each of these transformations. These transformations can be executed by any traditionally known manner. For example, polymerization of the liquid in the gel or solid state on the affected area may occur upon contact of coating material with the liquid on the affected phase is, as can happen in the case of N-vinyl-2-pyrrolidinone (NVP). In another case, the polymerization on the surface of the affected area can be realized by applying a curable liquid and polymersomes agent, for example, linear polyethylene oxide. Similarly, the gelation on the surface of the affected area can be realized by applying gelineau liquid (or gel) and generouse agent, such as NVP.
In certain embodiments of the implementation of the present invention, the bandage may contain drugs or active substances that can be released to the local tissue environment. Examples of suitable drugs or active substances include anti-inflammatory agents, antibiotics, analgesics and combinations of these drugs. Specific examples of suitable drugs or active substances include eucalyptus, lidocaine or steroids. Certain embodiments of the present invention may include substances that mediate tissue, for example, growth factors or RGD-peptides. Such substances that promote adhesion, preferably can be localized in the adhesive layer or the adhesive surface of the dressing. In other embodiments, implementation of the bandage may contain a drug to prevent postoperative adhesion tissue. Defined the options for implementation may contain substances preventing bacterial adhesion or colonization, or the accumulation of organic substances such as colloidal silver or microbial toxins. Such substances that prevent adhesion, preferably can be localized in the barrier layer or the barrier surface. Other embodiments of the present invention may contain a hemostatic agents, such as fibrinogen or thrombin, which contribute to the reduction of postoperative bleeding. In some embodiments, the implementation of the bandage may contain a medicinal substance, the vast growth of cells. For example, in some cases, tonsillectomy, if the tonsils are not removed completely, over time the tonsils can grow again. However, when the local application of drugs, inhibiting the growth of cells, the resumption of growth can be suppressed. If the surgery involves removal of the cancerous tissue, the bandage can be included anti-cancer drugs.
Any of the substances mentioned above, or any combination of these substances can be included in a pre-prepared options for dressings or bandages, formedin situ. In some embodiments, the implementation of two or more medicinal substances can be contained in a bandage and delivered through stand the conditions. For example, a multilayer bandage may contain different substances in each layer. Armband for mucosal tissue used for drug delivery, can be placed in any desired location in the cavity of the throat, mouth or nose, paranasal sinuses and the like, to implement the desired functions. For example, in one embodiment, small pieces of dressings containing steroids may be placed on or in nasal polyps for their reduction. In another embodiment, the bandage can be placed in the nasal cavity for drug delivery to the olfactory nerve and from there to the Central nervous system, for example, for the treatment of Alzheimer's disease, meningitis, etc.
Embodiments of the present invention described above can be performed in various ways. For various embodiments suit specific production methods and materials, regardless of whether you are dressing for a predetermined form or formedin situ. Description of the specific methods or materials in relation to specific variants of the implementation of the dressing does not exclude the use of other methods or materials for this particular variant implementation.
As materials used in a particular embodiment, may use is taken polymers. Suitable polymers can include natural and synthetic variants: polysaccharides (including, for example, polymers based on cellulose-based polymers of the alginate-based polymers of chitin and chitosan and polymers on the basis of glycosaminoglycans), protein polymers (including, for example, collagen, elastin, laminin, poly(amino acids) and pseudopolis(amino acid)), poly(α-complex oxyethira), polycaprolactones, poly(complex orthoevra), polyanhydride, polyhydroxybutyrate, polyphosphazene, polydioxanone, polyacetate, polyesters (including, for example, polyethylene glycol, polypropyleneglycol, polyethylene oxide, polypropyleneoxide), polyimide, polyurethanes, poly(vinyl alcohol) and copolymers, mixtures and composites thereof. In a more General sense, any biomaterial detecting one or more properties described herein as desired for the specific implementation may be suitable for use.
The choice of materials for use in certain embodiments of the implementation depends on their ability to form a hydrogel. The hydrogel is typically formed from a polymer network in which the dispersed high-volume water. The main chain of the polymer, as a rule, insoluble in water and may have a polar group attached to it for better interaction with water. Hydrogel is usually elastic enough and have mechanical similarities with living tissue, partly due to the high content of water.
The choice of materials may also depend on their ability to decomposition or dissolution after implantation. It is known that many of the above polymeric materials decompose or dissolvein vivo. As mentioned above, the materials may erode the surface or internally, or to have both properties. As the chemical composition and physical structure of the implanted material can affect the rate of decomposition. In various embodiments, the implementation of the surface and layers of the bandage is designed in such a way that the decomposition or dissolution occurs during the period from 48 hours to 14 days after implantation. In certain embodiments of the exercise of the adhesive layer to the tissue in contact with the saliva decomposes faster than the barrier layer.
Materials that can be used for forming the adhesive layer and/or adhesive surface may include, inter alia, polymers based on cellulose (based on ethyl cellulose, methyl cellulose, carboxymethyl cellulose, hydroxypropylmethylcellulose based or combination thereof). Other materials used for the adhesive layer or the adhesive surface may include, among other things, polyvinylpyrrolidone, polypropylenglycol, hyaluronic acid, collagen, chitin, chitosan, glycose is inopacan, proteoglycan, fibrin, fibrinogen, etc.
Materials that can be used for formation of the barrier layer or barrier surface may include, inter alia, polymers based on ethyl cellulose, methyl cellulose, polyethylene glycol and polypropylenglycol.
As mentioned above, as the adhesive surface and the barrier surface may be modified to provide adhesive or bioresistant properties. For example, the surface of the biomaterial may be chemically treated so that small molecules, peptides, proteins or functional groups associated with the surface. Such surfaces can detect significantly improved adhesive or bioresistance properties. Alternatively, for example, the surface can be processed by the bombardment of plasma or ions, or in other ways energy surface modification or equivalent methods. Such surfaces can also discover significantly improved adhesive or bioresistance properties. Moreover, the surface texture can also affect its adhesive or resistive properties. Recesses or pores can be, for example, is molded on the surface of the pressure made on the surface mechanically, chemically corroded or cut with a laser. There might also be other tech who tours or patterns
In addition, the three-dimensional structure of an adhesive layer or barrier layer may facilitate or hinder adhesion, and can also increase the mechanical strength. The porous layer may be formed by foaming with a gas, through the introduction and subsequent dissolution of pore or phase separation. Alternatively, for example, fibrous surface can be formed using the standard methods used in the textile industry, for example, tkanie or stalling. The size and shape of pores and voids between the fibers can affect the ability of adhesion and mechanical properties of the layer.
As surface texture, and three-dimensional layer structure of certain embodiments may affect the profile of drug delivery dressings. For example, when using dressings with high specific surface area of the drug or active substance is released from the inner layer structure and passing through the surface, can be delivered faster than using comparable in size bandages with a lower specific surface area. Similarly, high internal porosity headbands entails an increase in the speed of diffusion. Of course, on the profile of drug delivery implant is, including the solubility of the drug in the polymer carrier and the solubility of the drug substance in a biological environment, is influenced by many other parameters.
On Fig presents a method of using a variant implementation of the present invention, where the pre-formed bandage is placed on the surgical bed. The 700 patient has a postoperative plot 710, which was damaged mucosa tissue. After surgery, the user can impose a pre-formed bandage 730 on postoperative plot 710 using tweezers 720. As previously noted, the user can cut pre-shaped bandage 730 or to give it its own form, specific surgical bed, or dressing can be ready to use and have a shape and size corresponding to the specific surgical bed. In certain embodiments of the implementation of the bandage can be applied in a dry condition and for wetting the bandage and/or surgical bed can be used with saline.
On Fig presents a method of using a variant implementation of the present invention, in which the bandage is formedin situon the surgical bed. The patient 800 has polioviral the config section 810, which was damaged mucosa tissue. After completion of the surgical operation, the user can insert the distal portion of the delivery device 820 such that the distal end of the delivery device 820 was near the postoperative area 820. Material can be delivered through the delivery device 820. The material can form layers as described above. Finally deposited material formsin situbandage 830.
The devices and methods described above in relation to the different variants of implementation, in some cases belong to the mucous tissues in connection with surgical operations on the tonsils and adenoids. However, application of dressings may be considered for treatment of mucosal tissues in connection with surgical procedures in the area of the nasal sinuses, nasal shell, jaw, cheeks, pharynx, esophagus, stomach, intestines or anus.
In some embodiments, the implementation of the bandage can be used as a reference structure, or as added masses for pieces of fabric for the implementation of specific functions. For example, on Fig presents the results of repair of the nasal septum 1400 using reference patterns for fabrics 1410. In the surgical correction of a deviated septum, the doctor usually uses the t splint or similar device to support the restored partition. In the embodiment presented on Fig, the supporting structure for tissue 1410 is placed on the inner part or at least partially on the inner part of the restored nasal septum 1400. Unlike print, which is rather difficult to introduce and implement them manipulation, and later he requires removal of the cured walls, the supporting structure for tissue 1410 helps to strengthen the structure of the restored partition is partly due to the fact that she is glued to the fabric. The supporting structure for tissue 1410 may contain medicines, analgesic, anesthetic, or other means. The supporting structure for tissue 1410 may degrade over time, thereby eliminating the need for subsequent removal.
On Fig presents another example implementation in which a support film for fabric 1500 is attached to the back of the tongue 1510 in order to make this part of the language 1510 greater rigidity. There is evidence that the cause of sleep apnea can be Zapadnye language back during sleep and that rigid fabric on the back of the tongue can prevent Zapadnye. In some embodiments, the implementation of the supporting film 1500 placed on the back of the tongue, thereby thickening it, may have a longitudinal slit for easier breathing. Alternatively, domestic the bandage, in which you have entered lidocaine or another anesthetic that can be applied to the operated area after traditional surgical treatment of sleep apnea. As with other variants of implementation materials, patterns and textures supporting film 1500 you can choose based on the given features of these embodiments.
In other embodiments, implementation of the bandage can be used for other purposes. For example, the bandage can be used as a swab, for example, to stop the CSF leakage after surgery for skull base, as mentioned above. The bandage can also be used to close the puncture site through Klykova hole in the maxillary sinus. Such punctures sometimes do, for example, to provide access to the maxillary sinus to perform surgery. The bandage can be applied in oral and maxillofacial surgery or dental extractions to stop or reduce bleeding.
In another embodiment, film dressing for mucosal tissue can be used as a lining for iontophoresis for drug delivery to tissue or through it. The iontophoresis, in General, involves the promotion of a substance through the fabric under the influence of electric energy and the promotion of the substance towards the receiver of electrical energy. what one embodiment, the film may be applied as such to promote substance through any tissue membrane in the ear, the nose, throat and mouth.
In this example, the bandages were made from films consisting of modified cellulose.
The way - all the raw materials are produced in the form of solutions in certain concentrations, respectively; then the solutions individually or in a mixture, is applied to the PTFE sheet in one or two layers to get different films.
1. Raw materials
Polypropylenglycol (BCP), manufacturer: Alfa Aesar, catalog number 40811, lot number K28Q011 used immediately upon receipt.
Deionized water is prepared on the spot with the help of a deionization water.
The following source materials prepared for use in the form of solutions.
Ethanol producer Aldrich, No. cat. 493546-1L, batch No. 06862EH.
Ethylcellulose (EC), the manufacturer of the Spectrum, no cat. ET110, batch No. UT0371.
Methyl cellulose (MC), manufacturer Aldrich, No. cat. M0555-100G, batch No. 037K00611.
The hypromellose (HPMC), manufacturer Aldrich, No. cat. H3785-100G, batch No. 086K0115.
2. Preparation of solutions
Preparation of ethyl cellulose solution
Composition: 20% by weight ethyl cellulose (EC) in ethanol Pharmacopoeia of the United States.
Example: 37,5 g EC on 150 g of ethanol.
Preparation: weigh the desired amount of EC and ethanol, combine the ingredients in the container for storing stir the solution using a vortex mixer, before use, leave the solution on for 2-3 days.
Preparation of the solution of methylcellulose
Composition: 5% by weight of methylcellulose (MC) in ethanol/deionized water of the United States Pharmacopeia (1/1 by weight).
Example: 32 g MC 300 g of ethanol/300 g deionized water.
Preparation: weigh out the required amount MC, ethanol and deionized water, combine the ingredients in the container for storage, then add deionized water, stir the solution using a vortex mixer before use to leave the solution on for 2-3 days.
Preparation of the solution of hydroxypropylmethylcellulose
Composition: 7% by weight of hydroxypropylmethylcellulose (HPMC) in ethanol/deionized water of the United States Pharmacopeia (1/1 by weight).
Example: 28.6 g GPMC on 190 g of ethanol/190 g of deionized water.
Preparation: weigh out the required amount GPMC, ethanol and deionized water; place a weighted GPMC in the container for storage, put the ethanol in the tank to store and mix the solution, to give a powder GPMC evenly disperse in ethanol; add weighted deionized water in the tank in the mixing process to completion; to mix the solution before use to leave the solution on for 2-3 days.
3. Equipment or tools
Vacuum furnace: manufacturer Lab-Line Instruments model # 3608, is used for drying the film.p> Dryer gel: manufacturer Bio-Rad, model No. 583, used for drying and the alignment film.
Shaker: manufacturer New Brunswick Scientific, model # Classic C1, is used for mixing mortar.
The PTFE sheet: thickness 1.0 mm, dimensions: 6×6, 6×12, 6×18 cm2is used as the substrate for film coating.
Tray with PTFE coating: the size of the bottom: 10×20 cm2is used as the substrate for film coating.
Spatula stainless steel: used for film coating.
Wide neck reagent bottles 500 ml: used for storage solutions.
Analytical glasses: 250 ml, used for mixing solutions for film coating.
Disposable pipettes are used for liquid BCPs.
Aluminum foil: used for covering the deposited films.
4. Preparation of film
The thickness of the prepared film, first of all, depends on several factors, among which the bulk density of the material, the surface area of the substrate, the amount of solution of the material deposited on the substrate. To determine the thickness of cooked dry film you can apply the following formula:
where W is the number of solution of the material used for the casting of the film; C - dry residue of the solution material percentage by weight; D - about the roadways to the density of the material; A is the surface area of the substrate. PTFE and PE sheets or plates, or PTFE trays can be used as a substrate for casting films.
1) Preparing a single-layer film
A General method of execution
a) Based on the above formula, to weigh (or blend) of a certain quantity of a solution of the material (or solutions, if you are using a mixture of solutions).
b) Apply a weighted solution (or mixture of solutions) to the surface of the existing substrate (sheet or plate).
c) Placing the substrate (sheet or plate) coated with a coating in a chemical Cabinet or vacuum oven for slow drying.
d) After complete drying of the film, you should remove it from the surface of the substrate, to weigh and to measure the thickness.
An example of a single-layer film
Preparation of single-layer films of HPMC on the PTFE sheet size 6×18 square see
Specified thickness: 0.3 mm, the density of dry film: 0,85 g/cm3.
After weighing sheet PTFE (24,16 d) and weighing 39,36 g 7% by weight solution GPMC applied to the PTFE sheet, evenly distribute viscous solution GPMC across the sheet, place it in the tray with a covering layer of foil and then place the tray in a vacuum oven for slow drying (about 65 hours).
Weigh and measure the thickness of the dried film.
2) Preparation of two-layer film
General procedures the
a) First apply a protective layer in accordance with PPA, 1b and 1c.
b) After partial drying of the protective layer (drying for 1-2 hours depending on the specified film thickness. The degree of drying can be identified by the disappearance of wet areas on the coated surface). To start the application of the top layer.
c) Apply the top layer in accordance with PA, 1b and 1c.
d) After full drying of the double-layer film should remove it from the surface of the substrate, to weigh and to measure the thickness.
Example two-layer film
Preparation of two-layer films of HPMC on the PTFE sheet size 6×18 square see
The structure of the film: EC:MC:BCP/GPMC:BCP = 4:4:2/8:2 (by weight).
a) a Protective layer
Specified thickness: 0.1 mm, the density of the dry layer: 0,67 g/cm3.
Weigh sheet PTFE (24,58 g).
Weigh empty chemical glass and reset the scale. Weighing 1.86 g of 20% by weight solution of EC, 7.5 g of 5% by weight solution of the MC and 0,186 g BCPs, place in a chemical glass, mix the mortar until a homogeneous state (7,11 g of this mixture will be used for applying the layer on the PTFE sheet size 6×18 square cm, based on the fact that the solvent evaporates absent). Again weigh the formula for calculating the weight loss of solvent, then put the mixture in a weight equivalent to theoretically required quantity 7,11 g on the PTFE sheet. Evenly distribution is th mixture over the entire surface of the sheet, and then put it in the chemical Cabinet for evaporation of solvent.
b) an Adhesive layer for fabric
Specified thickness: 0.2 mm, the density of the dry layer: 0,85 g/cm3.
Weigh sheet coated with a protective layer and to control the rest of the weight over time.
Weigh and reset empty chemical glass. Weigh 30 g of 7% by weight solution GPMC and 0,502 g BCPs and place in chemical beaker to mix the mortar until smooth (20,92 g of this mixture will be used for applying a layer to a previously applied protective layer, on the assumption that the solvent evaporates absent); when the remaining percentage by weight of the applied protective layer will be about 25% by weight, again weigh the formula for calculating the weight loss of solvent, then put the mixture in a weight equivalent to theoretically required quantity of 20,92 g on the protective layer. Evenly distribute the mixture over the entire surface of the sheet, and then place it in a chemical Cabinet, vacuum furnace and dryer for gel for slow drying, for example, for Cabinet - 30 min, 50°C for oven for 3 hours, 35°C for oven - 17 hours, 50°C for oven - 4 hours, 70°C, dryer for gel - 2 hours.
Weigh and measure the thickness of the dried film. For example, 2.5 g and 0.31 mm for film CMT1114-1a.
An example of a multilayer film
Preparation of two-layer film of the MC on the sheet PTFE R is Merom 6×18 cm 2.
The structure of the film: EC:MC:BCP/MC:BCP = 4:4:2/8:2 (by weight).
a) a Protective layer
Specified thickness: 0.1 mm, the density of the dry layer: 0,67 g/cm3.
Weigh sheet PTFE (24,62 g).
Weigh empty chemical glass and reset the scale. Weighing 1.86 g of 20% by weight solution of EC, 7.5 g of 5% by weight solution of the MC and 0,186 g BCPs and place in chemical beaker to mix the mortar until smooth (7,12 g of this mixture will be used for the coating layer consisting of a sheet of PTFE 6×18 square cm, and assuming that the solvent evaporates absent); again to weigh the formula for calculating the weight loss of solvent, then put the mixture in a weight equivalent to theoretically required quantity 7,11 g on the PTFE sheet. Evenly distribute the mixture over the entire surface of the sheet, and then place it in a chemical Cabinet for evaporation of solvent.
b) an Adhesive layer for fabric
Specified thickness: 0.2 mm, the density of the dry layer: 0,85 g/cubic cm
Weigh sheet coated with a protective layer and to control the rest of the weight over time.
Weigh empty chemical glass and reset the scale. Weigh 40 g of 5% by weight solution of MC and 0.5 g of BCP and place in chemical beaker to mix the mortar until smooth (29,39 g of this mixture will be used for applying a layer to a previously applied protective layer, based on the fact that isarene the solvent is absent); when the remaining percentage by weight of the applied protective layer will be about 25% by weight, again weigh the mixture in order to calculate the weight loss of solvent, then put the mixture in a weight equivalent to theoretically required quantity of 29,39 g on the protective layer. Evenly distribute the mixture over the entire surface of the sheet, and then place it in a chemical Cabinet, vacuum furnace and dryer for gel for slow drying, for example, 35°C oven - 15 hours, 50°C oven for 8 hours, 35°C oven - 15 hours, 70°C dryer gel - 2 hours.
Weigh and measure the thickness of the dried film, for example, 2,22 g and 0,29 mm film CMT1114-4.
5. The composition of films
|The adhesive for fabric GPMC||The adhesive for tissue MC||The protective layer|
|Weight HPMC (g)||Weight BCP (g)||Weight MC (g)||Weight BCP (g)||Weight EC (g)||Weight MC (g)||Weight BCP (g)|
|GPMC single-layer film 6×18 cm2||was 2.76||N/a||N/A||N/A||N/A||N/A||N/A|
|GPMC two-layer film 6×18 cm2||the 1.44||0,36||N/A||N/A||0,28||0,28||0,14|
|MC double-layer film 6×18 cm2||N/A||N/A||1,45||0,36||0,28||0,28||0,14|
1) preparation of the solution
Preparation of solutions of these solutions leave for a few days to make sure that the solution became homogeneous. If the solutions nehomogenih, the films made from these solutions will be uneven.
2) the Storage and use solutions
Prepared solutions should be weighed, and then well sealed to avoid evaporation of the solvent. The loss of solvent due to evaporation can be calculated by weighing the solution after and before use. If there is a loss of solvent, not bhodemon to increase the number of solvent, specified in the recipe. The loss of solvent may cause changes in the concentration of the solution, which makes it difficult to control the film thickness.
3) Drying of the protective layer
Drying of the protective layer is important for the application of the adhesive layer. If the adhesive layer of fabric is applied to the protective layer, which has not dried up, both layers can be blended, so it can lead to the destruction of the two-layer structure. If the adhesive layer of fabric is applied on the protective layer, which was dried up, both layers can be easily separated from each other during subsequent use.
Factor that allows to determine the degree of drying is the residual weight percentage of the applied protective layer, which can be calculated using the following equation.
The residual weight % = (Wt-Ws)/(Wi-Ws)×100%,
where Wt is the weight covered with a layer of PTFE sheet after drying for a certain period of time, Ws is the weight of the PTFE sheet without coating and Wi is the initial weight of coated sheet of PTFE. If the residual weight percentage is in the range of 15-30%, or in the preferred embodiment, is 25%, should immediately apply the adhesive to the tissue protective.
4) Drying the adhesive layer
In the process of drying the adhesive layer (including a single-layer film) may be a number of problems, particularly when manufacturing is no thick layer. Typically, cracks, Sheibani, waves, folds, bubbles and uneven thickness appears in the case, if there is no proper control of the drying conditions.
Basically the slow process of drying, and in particular the slow evaporation of solvent from the surface of the film help to avoid the above mentioned problems and to improve the quality of the drying film. Meanwhile, the formation of waves on the surface can be avoided by using a dryer for gel when the film is almost completely dried up.
Check the adhesion strength of the film
To evaluate the adhesion strength of the samples of film wound dressings for use in the oral cavity was configured apparatus that can be used to evaluate adhesion properties of the film samples. By means of this apparatus it is possible to measure two types of adhesive strength, namely tensile strength and peel resistance.
1. Equipment for testing the adhesion strength and technique
The adhesion strength of the film in the gap, glued to fresh pork steak, can be tested by measuring the vertical force and the time of release. The test apparatus 1600 is installed as shown in Fig. Tests are performed at room temperature, 23°C. the Technique below.
1) Clean the Dimo cut the sample film 1610 certain size, for example, 15×15 mm2.
2) For fixation of fresh pork steak without the bone 1620 at the bottom of the plates used superglue.
3) For securing the cord in the centre of the sample (for single-layer film or the protective layer of the sample (for a two-layer film) is used adhesive tape. For additional fixing of the tape on the sample, you can use a small amount of superglue on the condition that the glue will not penetrate the sample and will not affect its adhesive properties.
4) Apply the adhesive to the tissue sample on the surface of fresh pork steak 1620, to press the film to give it to stick to the surface of the steak and leave on for 5 minutes (the processing time).
6) After 5 minutes to enable the timer and begin to add water in the cargo bowl 1630 gradually drop by drop until, until you come off the film or not will be filled Cup;
7) Mark the time of separation of the film from the surface of the steak.
8) If the film was cut out, measure the weight of the bowl 1630, filled with water, and mark the weight as the adhesive strength of the sample in the gap.
9) If the cargo bowl 1630 filled to the limit, and the film is still in place, record the time of separation. In this case, the adhesive strength is reported as the time of adhesion at full load.
2. Equipment for testing the adhesion strength at peeling the method execution
The adhesion strength of the film, glued to fresh pork steak, peeling can be tested by measuring the angle (45 degrees) and time of the trip. The test apparatus 1700 is installed as shown in Fig. Tests are performed at room temperature of 23°C. the Technique below.
1) You want to cut a sample film 1710 certain size, for example, 15×15 mm2.
2) For fixation of fresh pork steak without the bone 1720 at the bottom of the plates used superglue.
3) For fixing the rope on the edge of the sample (for a single-layer film or the protective layer of the sample (for a two-layer film) is used adhesive tape. For additional fixing of the tape on the sample, you can use a small amount of superglue, provided that the glue will not penetrate the sample and will not affect its adhesive properties.
4) Apply the adhesive to the tissue sample on the surface of fresh pork steak 1720 and push the film to give it to stick to the surface of the steak and leave it on for 5 minutes (the processing time).
6) After 5 minutes, turn the timer and immediately start to add water in the cargo bowl 1730 gradually drop by drop until, until you peel off the film or not will be filled bowl.
7) Stop the timer and note the time of detachment of the film from the surface of the steak.
8) which, after detachment of the film measure the weight of the bowl 1730, filled with water, and check the weight as the adhesive strength of the sample peel.
9) If the cargo bowl 1730 filled to the limit, and the film is still in place, then register the time of detachment. In this case, the adhesive peel strength is reported as the time of adhesion at full load.
In this example, the films were tested for properties required for bandages. In the process of testing for each adhesive film was measured by a specified time or the time required for making a hydrogel of the required form. Carboxylmethylcellulose showed better results than the hypromellose, which, in turn, was better than the methylcellulose. All adhesive film and the barrier film showed good ductility and lack of swelling. All adhesive film and the barrier film remained intact after the interaction with artificial saliva. When tested for solubility in 5 days karboksimetilcelljuloza film was dissolved in 70%dissolution hydroxypropylcellulose film was 40%, methylcellulose film - 25%, and the barrier film is dissolved by 15%. All values are given by weight.
As the invention is described with reference to certain embodiments of specialists in this field it is clear that there is a possibility of different is izmenenii and equivalent substitutions, not beyond the scope of the claims and do not affect its essence. In addition, there is the possibility of implementing various modifications to adapt a particular situation or material to the methods of the invention without leaving the scope of the claims and without affecting its essence. Based on the above, it is assumed that the invention is not limited to the specific embodiment described herein, and includes all variations falling within the claims.
1. Precast floor containing barrier material and the adhesive material, where the barrier material and the adhesive material adapted for simultaneous or sequential postoperative overlay on the mucous tissue to provide a multilayer film dressings that contain the specified layer of barrier material and a layer of the specified adhesive material in contact with the barrier material and the mucous tissue
the bandage remains in place in pristine condition for at least 48 h after postoperative overlay multilayer films on the mucous tissue, and
bandage resolves within 14 days;
when this multilayer film dressing has an outer bezel to surround the bed of the tonsils and a concave Central portion to match the shape of the box tonsils.
2. Modular floor according to claim 1, where the defence is RNA material, adhesive material, or both comprise a polymer.
3. Modular floor according to claim 1, where the barrier material, adhesive material, or both include a hydrogel.
4. Modular floor according to claim 1, where the barrier material, adhesive material, or both include a polysaccharide.
5. Modular floor according to claim 1, where the barrier material, adhesive material, or both materials include cellulose, modified cellulose or combinations thereof.
6. Modular floor according to claim 1, where the barrier material, adhesive material, or both materials include ethylcellulose, methylcellulose, carboxymethyl cellulose, hypromellose, or combinations thereof.
7. Modular floor according to claim 2, where the barrier material, adhesive material, or both materials additionally contain glycolic polymer.
8. Modular floor according to claim 2, where the barrier material, adhesive material, or both materials also include polypropylenglycol, polyethylene glycol, or both.
9. Modular floor according to any one of claims 1 to 8, optionally containing a therapeutic agent.
10. Modular floor according to claim 9, where therapeutic agent includes an anti-inflammatory agent, an anesthetic, an antibiotic, an analgesic or a combination of both.
11. Modular floor according to claim 1, made in the form of pre-formed multilayer film, tereasa the specified layer of adhesive material, in contact with the layer of barrier material.
12. Modular floor according to claim 11, where the total thickness of the bandage in the range from about 0.1 mm to about 0.7 mm
13. Precast floor on section 12, where the total thickness of the bandage is approximately 0.3 mm
14. Modular floor according to any one of § § 11-13, where the thickness of the adhesive layer of the fabric is approximately 0.1 mm
15. Modular floor according to any one of § § 11-13, where the thickness of the layer, resistant to abrasion, is about 0.2 mm
16. Modular floor according to any one of § § 11-13, where the adhesive for tissue dissolves in saliva faster than the layer resistant to abrasion.
17. Modular floor according to any one of § § 11-13, where the layer resistant to abrasion, has shock absorbing properties.
18. Modular floor according to any one of § § 11-13, where one or more layers have a color.
19. Modular floor according to any one of § § 11-13, where the border is thinner than the Central portion of the dressing.
SUBSTANCE: present invention refers to medicine, particularly to a method for making hydrogel wound dressings of polyvinylpyrrolidone or its monomer, agar, distilled water, ethylene or propylene, polyglycols, silver using ionising radiation wherein a complex of cationic polysaccharide, preferably chitosan, and silver is prepared by mixing AgNO3 with chitosan powder characterised by an average molecular weight of 40000 to 200000, previously degraded by irradiation with beam energy 10 MeV; the deposition is filtered, washed with distilled water and added to a mixture consisting of, wt %: 2-10% of polyvinylpyrrolidone or monomer, max. 5% of agar, at least 75% of distilled water and 1-3% of ethylene or propylene polyglycols, and gel prepared thereby is cross-linked by ionizing radiation of a dose of 20-30 kGy, preferentially 25 kGy.
EFFECT: provided high biological activity and long effective use of surgical dressings.
3 cl, 6 ex
SUBSTANCE: invention refers to pharmaceutical industry and medicine. An antimicrobial, haemostatic and wound healing agent is created for healing wounds and burns, and contains wt %: polyvinyl pyrrolidone 2.0-10.0; agar 1.0-3.0; polyethylene oxide 1.0-3.0; myramistine- 0.01-1.0; aminocaproic acid 0.01-5.0; water - the rest. The agent is prepared by medical polymers cross-linking under ionising radiation.
EFFECT: agent exhibits elasticity, tensile strength, wound effluent sorption properties, transparency that allows following up a course of a wound process, painless removal with a wound surface, creates an optimum wound microclimate (humidity, temperature), provides antimicrobial, haemostatic and wound healing effects, keeps structure under ionising radiation.
SUBSTANCE: invention discovers the application of a liquid composition for preparing a drug for open wounds and burns. The composition contains a component specified in the salts containing An+ cations and anions formed by halogen oxides according to general formula [OmX] - where A represents lithium, sodium, potassium or calcium, X represents halogen atom, m=1, n=1 or 2, a component specified in the oxygen donors, and a liquid binding agent. In addition, the composition can contain a stabilising agent for the oxygen donors. Said composition promotes tissue cell growth in a wound, thereby providing better tissue regeneration and wound healing.
EFFECT: invention also concerns a wound bandage containing said composition.
28 cl, 3 tbl, 5 ex
SUBSTANCE: invention refers to haemostatic agents and can be applied successfully as a local haemostatic. The haemostatic preparation on the basis of zeolite includes calcium compound, pulverised calcium carbonate being contained as calcium compound, and also nanoparticles of boehmite and polysaccharide and/or lignin.
EFFECT: preparation allows for reducing exothermic effect of hydration and does not cause painful sensations and a corrosive burn of open tissues.
4 dwg, 2 tbl
SUBSTANCE: described bandaging material contains non-volatile silicone fluid mixed with colloidal silicon dioxide, volatile solvent and silicone elastomer. Material is improved composition applied for specific tissue area amenable to pathogenic infections and/or scarring.
EFFECT: has improved composition.
33 cl, 4 tbl, 7 ex
SUBSTANCE: the present composition includes nonvolatile, a silicone, fluid substance in the mixture with finely divided silicon dioxide and antibacterial active substance. Pharmaceutically active substance is a nondecomposing one and manifests physical stability in the composition.
EFFECT: higher efficiency.
31 cl, 5 ex, 2 tbl
FIELD: medicine, in particular experimental and clinical surgery and transplantation methods.
SUBSTANCE: claimed wound coat in form of sponge, gel, colloid solution, film contains chitosan with deacetylation ratio of 0.95-0.99 and molecular weight of 10-1000 kDa in form of chitosan ascorbate containing (in 1 g of dry chitosan): ascorbic acid 1.8 g; as well as chondroitinsulfuric acid 500-100 mg; hyaluronic acid 10-100 mg; heparin 2.5-5 mg, and serum cattle growth factor 11-220 mum. Wound of present invention is useful in reduction of skin wound defects.
EFFECT: more effective method for reduction of skin wound defects.
2 tbl, 1 ex, 1 dwg
SUBSTANCE: disclosed is a respirator, having a laminate capable of reversible adhesion to human skin, having a substrate; an organosilicon mixture attached to the substrate; and an organosilicon adhesive film attached to the organosilicon mixture. The organosilicon mixture is essentially homogeneous and contains a hot-melt organosilicon adhesive with high adhesive power such as Bio-PSA-7-4560, which is solid at room temperature, and a low adhesive power organosilicon adhesive such as Bio-PSA-7-4101, which is a liquid low adhesive power organosilicon material. Also disclosed is a version of the respirator and method of making said respirator.
EFFECT: enabling reversible adhesion of the article to the skin of the user and reliable bonding of the base of the article and the organosilicon mixture.
9 cl, 3 tbl, 6 ex
SUBSTANCE: invention refers to medicine. What is described is an adhesion cover comprising a body of the adhesion cover with its substrate and adhesion layer on the substrate, wherein the body of the adhesion cover comprises a periphery, a centre and an intermediate portion between the periphery and the centre with the intermediate portion of the body of the adhesion cover having a thickness greater than that of the centre the body of the adhesion cover and the centre of the body of the adhesion cover having a thickness greater than that of the periphery of the body of the adhesion cover; what is also presented is a method for making it. The cover has the adhesion layer retaining its original shape.
EFFECT: improved usability.
10 cl, 1 tbl, 8 ex
SUBSTANCE: invention refers to medicine. What is described is an adhesion cover having a substrate, and an adhesion cover formed at least on one surface of the substrate, wherein the adhesion cover has a periphery and a centre; the adhesion layer has voids; the voids in the adhesion layer are localised in the periphery; the adhesion layer in the centre substantially has no voids, while the periphery of the adhesion layer preferentially comprises the voids in the average number of 2.0 to 100 voids/mm3.
EFFECT: adhesion cover is highly resistant to skin separation; there is no easy protrusion of the component of the adhesion layer from an edge of the adhesion cover when stored in a package; inhibited adhesion of the adhesion cover to the inner surface of the package; the adhesion cover can be easily removed from the package and avoided rise of the edges of the adhesion cover caused by cold plastic flow during adhesion to skin.
8 cl, 6 dwg, 1 tbl, 4 ex
SUBSTANCE: invention refers to medicine. What is described is a surgical barrier which includes a wound-facing polymeric coating comprising an enteric polymer, and at least one flexible substrate wherein at least one mentioned flexible substrate having at least one exterior surface with said polymeric coating is applied on at least one mentioned flexible substrate so that substantially cover at least one exterior surface thereof. There are also described a method for inhibiting the formation of adhesions in a patient who has undergone a surgical procedure, and a method for repairing a gastric or duodenal perforation.
EFFECT: reduced probability or prevention of the formation of adhesions associated with the surgical intervention.
27 cl, 4 tbl, 7 ex
SUBSTANCE: invention refers to medicine, more specifically to chemical-pharmaceutical industries and medical equipment. What is described is a fixer representing an adhesive tape consisting of paper base 45-55 g/m and a pressure sensitive adhesive coating one of the base sides. The adhesive layer is protected by siliconised paper.
EFFECT: agent provides higher adhesive properties, better vapour permeability, does not irritate skin, possess higher viability.
5 cl, 2 tbl
FIELD: medicine, pharmaceutics.
SUBSTANCE: invention refers to medical equipment and may be used in producing adhesive elements for colo-, ileo- and urostomy bags and urine collection bags. The composition contains, wt %: acrylate copolymer 10-20, polyisobutylene 15-35, castor oil 10-20, hydrocolloids 20-30, and a target additive 0.1-30.
EFFECT: invention aims at preparing the adhesive polymeric composition having improved adhesion to polyolefines and natural latex, and also has a therapeutic and preventive action on skin, causes no irritations and erythemas.
4 cl, 1 tbl, 5 ex
SUBSTANCE: present invention refers to medicine, more specifically to a gel composition for a medical material or a hygienic material which contains a liquid rubber ingredient having a functional group able to create cross linkages, in a molecule, and 90 weight parts or more and 1250 weight parts or less of an organic liquid ingredient in relation to 100 weight parts of the rubber ingredient with the gel composition being cross-linked.
EFFECT: composition for the medical material or the hygienic material contains a great amount of the organic liquid ingredient, has sufficient elasticity and can hold its shape.
7 cl, 4 tbl
SUBSTANCE: invention refers to medicine. What is described is a bandage for pain region processing. The bandage provides cooling and delivery of therapeutic formulations to this region. The bandage comprises a bearing carrier, an interpenetrating network of gel-type dope of polyvinyl alcohol and a cross-linking agent wherein the interpenetrating network is located in the bearing carrier, and at least one additional therapeutic agent.
EFFECT: bandage may be applicable many times on various body parts.
21 cl, 4 dwg, 3 ex
SUBSTANCE: invention refers to medicine. There are described methods for preparing biomaterials to be used as a woven sealant, complete sets containing precursors for preparing the biomaterials, and the resultant biomaterials. The biomaterials are prepared of the composition containing at least molecules of the first and second precursors, wherein: i) a molecule of the first precursor is a polymer of poly(ethylene glycol) having x nucleophilic groups specified in a group consisting of thiol or amine groups, wherein x is equal to 2 or more, preferentially 3, 4, 5, 6, 7 or 8; ii) a molecule of the second precursor is described by general formula: A-[(C3H6O)n-(C2H4O)m-B]i, wherein m and n represent integers within the range 1 to 200, i is more than 2, preferentially 3, 4, 5, 6, 7 or 8, A represents a junction point, B represents a conjugated unsaturated group.
EFFECT: biomaterials are able to glue tissue surfaces together quickly without complication of common therapy.
1 tbl, 10 ex