Sealing device and delivery system

FIELD: medicine.

SUBSTANCE: invention relates to medical equipment, namely to sealing device for reparation of heart defect and vessel diseases in the process of performing surgical operations for treating such diseases as patent foramen ovale (PFO) or heart stunt, vascular system diseases, etc. Sealing device contain stretchable frame ad sealing element. Frame contains multitude of wires, each of which passes from proximal end to distal end of frame. First and second segments from multitude of wires form wound proximal loop and distal loop respectively. Multitude of wires form proximal disc and distal disc when sealing devise is extended. Proximal disc and distal disc are located between proximal and distal loops. Each wire from multitude of wires forms respective petal of proximal disc and respective petal of distal disc. Respective petals form zones of overlapping and unsupported sections. Sealing element, at least, partially encapsulates extending wire frame.

EFFECT: invention has improved compatibility with heart anatomy, it is easier to extend, reposition and return into initial condition in the place of opening.

25 cl, 16 dwg

 

The technical field to which the invention relates

The present invention relates to a sealing device for repair of heart defects and diseases of blood vessels during surgical operations for the treatment of diseases such as patent foramen ovale (PFO) or shunt in the heart, vascular system, etc. and, in particular, to the obturator and delivery system of the TRANS obturator-catheter.

The level of technology

The sealing device can be used to close in the implementation of many types of surgical operations for the treatment of diseases such as cleft septum of the heart, PFO, etc.

In the implementation of surgical open-heart surgery opened the chest. To avoid injury and complications during surgical operations on open heart uses different technology TRANS-catheter closure. This technology means the delivery of the obturator through the catheter to the opening or the source of the disease. The device is located in the hearth of the disease and permanently deployed.

There are many devices for the delivery of TRANS-catheter. They include devices that require on-site Assembly opening or require suturing or buttoning buttons" elements of discrete devices. Other devices include sa�rasshirjajusheesja device. Such self-expanding device, usually difficult to visualize, they are cumbersome to load, difficult to localize and repositioning in place of the autopsy. The majority of self-expanding devices do not correspond to the anatomy of the heart, leading to erosion of tissue.

Example of a self-expanding device is a device, which includes a patch, a third tube, the guide wire, superelastic wire, a trigger mechanism, a delivery device in a protective case. Superelastic wire is attached to the trigger, and the wire, the trigger mechanism, the patch, the guide wire and the third tube are inserted into a delivery device in a protective case for transporting to the hole. After delivery, the patch is placed on the hole, and the wire is deployed on the patch. If necessary, the patch and wire repositioned, and the trigger is activated, releasing the wire.

Another example of a self-expanding device is a device that includes a set of tubular metal pipes and possibly locking device, made of fiberglass, including the hollow portion of the device. A set of metal tubes forming a medical device, a bell-shaped form, which can break down when driving through the catheter during deployment in a body of a patient�NTA.

These and other self-expanding devices designed for TRANS-catheter delivery, require Assembly either before use or during operation. They are also difficult to reposition or lead to its original state after the first deployment, and they are not consistent with the anatomy of the heart. For these reasons, it is desirable to improve the sealing device for use in TRANS-catheter technology. Such sealing device will be preferable to have improved compatibility with the anatomy of the heart and they will be easier to deploy, reposition and return to its original state in place of the autopsy.

TRANS-catheter self-expanding sealing devices may be delivered and deployed by various means. For most TRANS-catheter delivery devices choose one of the two major systems deployment device: pulling back the outer catheter to release the device or pushing the device, freeing the pusher catheter. Each of these systems use the handle to activate the mechanism during deployment of the device. This system includes a flexible pushing element for pushing the sealing device through the catheter and remotely located control means for pushing the pushing element. In da�nom example, the management tool includes a threaded hollow rod, connected to the pushing element, and manually rotating the threaded rotor mounted on the stem. Moving along the thread of the spindle, the drive rotor for its rotation at a fixed angle to promote stem and pushes the element at the fixed distance.

An example of a system that uses the pulling of the outer rod, or catheter, is the system, which includes the handle, which can selectively hold the components of the delivery system in any configuration during deployment and positioning of the device. The outer catheter of the system is drawn, and the device is released by operation of the moving lever and rotating the toothed ring on the handle of the delivery system.

Although these or other device delivery systems are designed to deploy TRANS-catheter devices during their operation requires the use of a tight rotating threaded rotor, or need to make significant efforts for the take-down of the outer catheter for use the entire length of the constrained device. Most deployment systems are either irreversible or very difficult are reversed after deployment. For these reasons, it is desirable to provide an improved delivery system of the device sealing. Such a delivery system preferably they�et arm, which can be done with one hand and which can perform multiple manipulations with minimal effort or motion.

Disclosure of the invention

The invention relates to a sealing device, which comprises: stretching the frame with lots of wires, each of which extends from a proximal end to a distal end of the frame;

the first and second segments of each of the plurality of wires forming the coiled proximal loop and a distal loop, respectively, and the multitude of wires that form the proximal disc and distal disk when deploying the sealing device,

the proximal disk and the distal disc is located between the proximal and distal loops,

and each wire of the plurality of wires forms a corresponding proximal petal disc and a corresponding distal lobe of the disk;

and the petals form a zone of overlap and unsupported sections,

and a sealing element that at least partially encapsulates the stretchable conductive frame.

The sealing device is made self-centering during deployment.

Stretchable frame may further contain coiled intermediate loop, formed by a multitude of wires and located between� proximal disk and distal disk.

Advantageously, in this case the sealing element closed proximal and distal disks and proximal, distal and intermediate loops.

Stretch the wire frame may include at least 5 wires.

Advantageously, the sealing element contains a material selected from the group consisting of polyester, polyethylene, polypropylene, fluoropolymer, polyurethane, silicone, nylon and silk.

Wherein the fluoropolymer includes polytetrafluoroethylene, which contains stretchable polytetrafluoroethylene.

Preferably, the set of wires includes nitinol.

The sealing element is attached to lots of wires.

Additionally, the device may include a distal buffer located distally relative to the distal loop.

The device further comprises a locking loop.

Many wires can pass helically from the proximal end to the distal end.

Preferably, at least one of the loops is formed in a noncircular shape.

The sealing element is attached to many wires of adhesive that can produce contain FEP.

Preferably, nitinol contains 10 wt%, platinum. Nitinol is totim a nitinol core.

In this apparatus, the first part of the petals define naru�tion proximal diameter of the disk.

The second part of the petals define the outer diameter of the distal disk.

The intermediate loop may contain a portion of each wire of the plurality of wires in a looped configuration.

Parts adjacent petals of the proximal disk can overlap.

Parts adjacent petals of the distal disk can overlap each other

The device may comprise a distal buffer located distally relative to the distal loop

The device may further comprise a locking loop

It is clear that both the foregoing General description and the following detailed description are exemplary and explanatory and are intended for further explanation of the invention.

The accompanying drawings provide a better understanding of the invention and constitute part of the present description, illustrate embodiments of and together with the description, explain the principles of the invention.

Brief description of the drawings.

Fig. 1 is a perspective view of the deployed sealing device attached to a distal end of the delivery system.

Fig. 2A to view extended frame of the sealing device.

Fig. 2B is a front view of a loop device sealing.

Fig. 2C is a front view of the frame of the sealing device.

Figs 3A-types of winding components cartridge

Fig. 4A is a side view us�incorporating the cartridge.

Fig. 4B is a top view of a winding of the cartridge.

Fig. 5A is a side view of the extended braided sealing device.

Fig. 5B is a side view partially extended braided sealing device.

Fig. 6 is a side view of a variant of implementation of the self-centering of the sealing device.

Fig. 7 is a side view of the deployed device sealing

Fig. 8 is a perspective view of the delivery system, which includes the arm is deployed and attached to the sealing device.

Fig. 9A-D is a flowchart of an algorithm describing the operation of the delivery system.

Fig. 10 is a perspective view of the handle of the deployment device sealing.

Fig. 11 is a perspective view of the handle of the deployment of the sealing device in the collection.

Fig. 12A is a top down view of a variant of implementation of the first linear actuating mechanism.

Fig. 12B is a side view of a variant of implementation of the first linear actuating mechanism.

Fig. 12C is a side view of a variant of implementation of the first linear actuating mechanism.

Fig. 12D is a side view of a variant of implementation of the first linear actuating mechanism.

Fig. 13A is a perspective view of a variant embodiment unblocking actuating mechanism.

Fig. 13C is a perspective view of a variant embodiment unlock actuator in an activated state.

Fig. 14C is a front view of a variant of implementation of the first linear actuating mechanism.

Fig. 15 is a front view of a variant of implementation of the first linear actuating mechanism with cast detail of the spring.

Fig. 16 is a perspective view of a spring mechanism.

The implementation of the invention

The first embodiment concerns a device for sealing with expanding frame formed by multiple wires extending from a proximal end to a distal end of the frame and forming a proximal and a distal loop with a sealing element at least partially encapsulating the expanding wire frame.

Fig. 1 shows an embodiment of a device 100 sealing. The sealing device 100 will be described in detail below. The sealing device 100 can be placed in a third tube 104. The third tube 104 includes a sealing device 100, the first tube 102 and second tube 108, the return wiring 110 and the retaining loop 111. The third tube 104 may be made of a material Pebax® or other material with appropriate biocompatible and mechanical properties. Can be selected to be impermeable to x-radiation material. The third tube 104 may be constructed with reinforcing the criss-crossing�th or without to ensure islamologist and durability of the chosen use case. The third tube 104 may also be manufactured with ringtoneprincipal marking layer or without it. Design and materials for the manufacture of the third tube 104 can be selected based on other characteristics, such as islamofascist, manageability and reducing injuries vessels. Specialist in the art are aware of the existence of a wide variety of materials that can be used to implement this invention. The third tube 104 may have any size, but it is preferable to use a tube 10fr. internal diameter approximately 0,048 mm and an outer diameter of around 0.33 mm. the Third tube 104 can be used with wire guide wire and may include a hole 103 quick replacement. The tip of the first tube 104, should preferably be curved, which helps in orienting and delivery device 100 sealing from the place of access to the nidus wire with wire or without it.

Fig. 1 also shows a first tube 102. As mentioned above, the first tube 102 may be placed in a third tube 104. First tube 102 may have any outer diameter, but preferably, the size should correspond to the inner lumen of the third tube 104. First tube 102 may be made of a material Pebax®, or from any other mA�of Arial with appropriate biocompatible and mechanical properties. First tube 102, preferably, is Trekhprudny the catheter. The openings may have any geometric shape, but preferably have a round or oval shape, or a combination. First tube 102 may be used to accommodate and facilitate the deployment device 100 sealing. First tube 102 may be used in cooperation with the second tube 108, causing the sealing device 100 of the extruded from the distal end of the third tube 104, once the sealing device 100 has reached the source of the disease. First tube 102 may also have the function of holding the device 100 sealing in the delivery system prior to final deployment of the device. First tube 102 has a hole 109 in the end position of the distal end, allowing the locking loop 111 to come forward during deployment of the device. The hole 109 and the protruding locking hinge 111 provide a connection to a water delivery device. The locking hinge 111 is shown in its expanded condition to hold it in a predetermined form. First tube 102 may have a treated surface or may be coated with a material that improves the biocompatibility or of changing or enhancing surface friction.

First tube 102 may accommodate a second tube 108. The second TRU�ka 108, substantially has canalicular design with oval cross section and may have an outer diameter approaching the inner diameter of the first tube 102. The preferred range of the outer diameter is approximately 1.27×0.68 mm with a flared distal end. A second pipe 108 may be made of any suitable biocompatible material including polymers or metals. The preferred material is REEK (polyetheretherketone). A second pipe 108 may be used to facilitate delivery and deployment device 100 sealing in the nidus. The second tube 108 is threaded through the loop of the device 100 for sealing retention device 100 of the seal in the delivery and sustainability during deployment of the device 100 sealing. Loop sealing device will be described separately.

Return 110 wiring looped through the two smallest of the inner lumen of the first tube 102 and through the proximal loop of the device 100 sealing, ensuring adherence to the delivery system and return to its original state once deployed the device sealing. Return wiring 110 continues along the entire length of the first tube 102 at the ends, which are displayed on the handle that is used to deploy the device 100 sealing. Return wiring 110 m�can be made from any biocompatible material of sufficient strength and size. The preferred material is ePTFE (expanded polytetrafluoroethylene).

As shown in Fig. 2A, the sealing device 100 is formed with a wire frame 200. When placing a delivery wire frame 200 is in the extended position to the second tube 108 and the inside of the third tube 104. The wire frame 200 may have any size suitable for the application, but the preferred end outer diameters are 15, 20, 25 or 30 mm. Wire frame 200 is formed of a closed wire construction. To create a wire frame 200 can be used any number of wires. It is preferable to use five wires. The wire frame 200 can be formed from wires that have elastic characteristics allowing the wire frame 200 to be in a compressed state for basic or thoracoscopic delivery catheter and zamorachivatsja to induced "memory" configuration, once located on the site of the disease. Elastic wire may be a spring wire or a wire made of NiTi alloy (nitinol) shape memory or superelastic wire NiTi alloy. Elastic wire may also be a wire type DFT of NiTi alloy containing various metal at the core. Preferably, the wire frame 200 may be �was established from wire type DFT, made of NiTi alloy and containing impermeable to x-radiation metal at the core. After deployment, the wire design takes the form of a deployment without permanent deformation.

The wire frame 200 and other mentioned wire construction formed from an elastic wire materials, which have an outer diameter of 0.12-0.4 mm. In a preferred embodiment the outer diameter is approximately 0.3 mm. Formed by the wire frame 200 includes a distal buffer 208, the distal loop 204, the retaining loop 206 may Central loop 203 and the proximal loop 202. Fig. 2B shows the position of the elastic wires during formation of the loops 202, 203 and 204 of the wire frame 200.

Fig. 2C shows the disk that was created when you deploy the wire frame 200. Elastic wire, forming the wire frame 200 during the expansion, have the shape of the petals 212. Preset configuration of the elastic wire wire frame 200 allows the frame to twist in time of deployment. This forms a twisting petals 212. The deployed petals 212 form a wire frame 200 with an outer diameter 214. The deployed petals 212 covered with the sealing element 106 and forming the proximal and distal disks will be described later. The petals 212 op�emaline form a zone 216 overlap to improve the quality of sealing. The radius of the petals 212 can be maximized to minimize bending of the elastic wire and reduce the size of the unsupported sections of the petals 212, which will increase the quality of the seal device, to reduce metal fatigue in the wires and bends will help to reduce the amount of force causing the load on the device. The deployed petals 212 form a disk on both sides of the Central loop 203. Detailed configuration will be described next.

Design wire frame 200 may be formed by a variety of means, including a winding mechanism with automatic tensioning wires or manual winding with load tension of each wire during the formation. Fig. 3A-C shows the key Central pin 300 and the cover 304, which can be used to assist in the creation of wire frame 200. Specialist in the art it is clear that there are many suitable materials for use in the production or equipping tool. The preferred material for use in the formation of a Central pin 300 is a high strength cobalt steel. The preferred material for use in the manufacture of plugs 304 and wound cartridge is a corrosion-resistant tool steel. The winding device of the cartridge b�children described below. Shown in Fig. 3A key Central pin 300 may have a groove 302, which can be used to secure elastic wire during the formation of the device. Key Central pin 300 may be used for guiding an elastic wire through the hole in the stub 306 304 structural elements which are shown in Fig. 3B-S. Plug 304 is preferably formed with a recess 308 in the cone for secure attachment to the winding Chuck. Elastic wire is held in the groove 302, and is inserted through the hole in the stub 306 304, forming a buffer 208 and the retaining loop 206. Key Central pin 300 is also used for loops 202, 203 and 204. During the creation of the device after formation of the buffer 208, the elastic wire may be wound around a key Central pin 300, forming a distal loop 202. Other loops 203 and 204 may be formed in a similar manner. Key Central pin 300 is inserted into the recess 304, after which the elastic wire may be inserted into the winding grooves of the holder.

Winding cartridge can be used for secure attachment and formation of elastic wires during the formation and processing of the device 100 sealing. Standard wound cartridge can be manufactured, as is usually accepted in this about�Asti equipment. The materials used for the manufacture of such winding cartridge, previously specified. A preferred embodiment of the winding of the cartridge shown in Fig. 4A and 4B. Fig. 4A shows the side view of the winding of the cartridge 400. Fig. 4B shows a top view of a preferred option winding of the cartridge 400. Winding the cartridge 400 includes an opening 402, which has the shape and size required to hold the key Central pin 300 and the plugs 304 during the formation of the device. The slots 404 in the surface of the holder is used to secure attachment and formation of elastic wires in the wings 212. The grooves 404 can be of any diameter, but the preferred size needs to accommodate the outer diameter of the elastic wire. In the embodiment shown in Fig. 5A, the winding design of the cartridge may be used to form a Central loop 203, and proximal petal loop 204. Profiled wire may be compressed when assembling the reel of the cartridge is heated and processed to give a predetermined shape, as is widely known in the art.

Fig. 5A shows an embodiment of a device 100 of the seal, which is a wire frame 200 and the sealing element 106 in the collection. The sealing element 106 may be attached to the wire frame 200 gluing�m substance. The wire frame 200 may be covered with an adhesive substance, for example, fluorinated ethylene propylene (FEP) or other suitable adhesive material. The adhesive material may be applied by contact coating, powder coating, coating by immersing, coating applied by spraying or by any other suitable means. The preferred embodiment of the bonding material is FEP, applied by electrostatic powder coating. The sealing element 106 can be made of many materials, such as DACRON®, polyester, polyethylene, polypropylene, fluoropolymers, polyurethane, foam tape, silicone, nylon, silk, sheet superproxy material, phenolic resin, polyethylene terephthalate (PET), collagen, pericardium tissue or any other biocompatible material. In embodiments, the sealing element 106 can be formed of a thin porous ePTFE (expanded polytetrafluoroethylene) substrate. The sealing element 106 is designed to enhance the sealing characteristics of the device 100 of the containment by ensuring that blocking the source of the disease and presence of increasing porous working environment.

Fig. 5A also shows the proximal, distal and Central loop (202, 203 and 204), respectively coating�s sealing element 106 and wrapped in foil. Loop 202, 203 and 204 can be wrapped in foil to enhance the adhesion of a sealing element 106 to the device. The film used for wrapping loops 202, 203 and 204 may be made from any biocompatible thin material, but the preferred material must contain many layers of thin porous ePTFE, which can be separated by one or more layers of non-porous FEP.

Fig. 5B shows an embodiment of a device 100 of the seal, which includes a sealing element 508, partially covering the wire frame 200. Partially covered, the device may have either a distal or proximal bladder is covered partially or completely sealing element 508.

Another variant of realization of the device is self-centering device 600. As shown in Fig. 6, the self-centering device comprises a wire frame 602, similar to the wire frame 200. Self-centering device 600 is a wire frame 602 and the sealing element 604 in the collection. Wire frame 602 can be formed on similar technology and material as the wire frame 200, but does not have a Central loop. Wire frame 602 contains the distal buffer 606 is covered with a distal loop 608, covered with a proximal loop 610 and the locking loop� 612. Preset configuration of the elastic wire wire frame 602 allows the frame to spin when you deploy and create a centering area 614 of the device 600 during deployment. During deployment, the centering area 614 may be centered itself on the site of the nidus forming a disk containing the petals on both sides of the centering zone 614 and the source of the disease.

Fig. 7 shows a fully expanded sealing device 100. During deployment, the third tube 104 terminates the exposure of the sealing device 100, and the device returns to its pre-defined shape. During deployment and fixation of the locking hinge 111 is released from the first pressure tube 102 and returns to a preset shape, twisting from the proximal loop 202. Thus, the device is fixed in the unfolded state. Fig. 7 also shows the position of the proximal and distal disks, elements 702 and 704, a relatively proximal, Central and distal loops 202, 203 and 204, respectively.

Fig. 8 shows a perspective view of the device 100 of the seal attached to the delivery system and comprising a first tube 102, the third tube 104 and a handle for deploying the device 100 sealing. Fig. 8 further shows a first linear�th actuator 802, the flushing port 804, the second linear actuator 806, unlock actuator 808, frame 810 and the groove 812 along the length of the frame. The first linear actuator 802 may have a different configuration, the description of which is included below.

Fig. 9A-D shows the flowchart of the algorithm that describe the movement of the various components of the delivery system and attached devices 100 of the seal during use. Loading device 100 of the seal in the delivery system prior to its use is described in Fig. 9A. Arm components of the delivery system shown in Figures 8, 10 and 11. The doctor may flush the delivery system by attaching a syringe or other suitable tool to the flushing port 804 and filling the system with saline or any other appropriate rinsing agent. Then, the first linear actuator 802 may be inserted into the groove in the frame 812 810, overcoming the resistance of the spring 1100. Spring 1100 can be manufactured, as shown, or can act as a flat spring step spring or may have any other form that is widely known in the art. Such action provides the rotation of the core of the lever 1000 control, as shown in Figure 11, around the sliding rod 1102 to the side of the frame 810. This movement frees the first line�tion actuator 802, a distal recess 1104 in the calibration box 1103 and prevents proximal and distal movement of the second tube 108. Calibration box 1103 may be manufactured from any material with suitable mechanical characteristics.

Standard arm, arm components, devices or catheters used in medical delivery devices may include well known materials such as amorphous thermoplastic materials include polymethylmethacrylate (PMMA or acrylic polymer), polystyrene (PS), acrylic nitrile-butadiene-styrene (ABS), polyvinyl chloride (PVC), modified polyethylenterephtalate (PETG), acetobutyrate cellulose (CAB), semi-crystalline plastics that include polyethylene (PE), high density polyethylene (HDPE), low density polyethylene (LDPE or LLDPE), polypropylene (PP), polymethylpentene (PMP); amorphous technical thermoplastics that include polycarbonate (PC), Polyphenylene (PPO), modified Polyphenylene (ModPPO), polyfenilen ether (RRE), modified polyfenilen ether (ModPPE), thermoplastic polyurethane (TPU), polycrystalline technical thermoplastics, which includes polyamide (PA or nylon), Polyoxymethylene (RUM or acetal), polyethylene terephthalate (PET, thermoplastic polyester), polybutylene terephthalate (PBT, thermoplastic polyester), ultrahigh molecular weight polyethylene (UHMW-PE), thermoplastics with high performance brushless�ticks, which include polyimide (PI, mediterania plastic), polyamidimide (PAI, mediterania plastic), polybenzimidazole (PBI, mediterania plastic); amorphous thermoplastics with high performance characteristics that include polysulfone (PSU), polyetherimide (PEI), polyethersulfone (PES), polyarylsulfone (PAS), semi-crystalline thermoplastics with high performance characteristics that include Polyphenylene sulfide (PPS), polyetheretherketone (REEK); and semi-crystalline thermoplastics with high performance, fluoropolymers that include fluorinated ethylene propylene (FEP), ethylene chlorotrifluorethylene (ECTFE), ethylene, ethylene-tetrafluoroethylene (ETFE), polychlorotrifluoroethylene (PCTFE), polytetrafluoroethylene (PTFE), polyvinylidene fluoride (PVDF), performcancel (PFA). Other well-known materials that are used in medicine include elastomeric organosilicon polymers, a thermoplastic elastomer or a thermoplastic copolyester (REACH) and metals such as stainless steel and nickeltitanium alloys.

Distal recess 1104 and the proximal recess 1106 in the calibration box 1103 can be used to aid in the positioning of the first linear actuating mechanism 802 in the groove of the frame 812. The distance between the two notches I 1106, consequently, it could be the length of the device 100 of the sealing, when the second light pipe 108 to loading into the delivery system. Calibration box 1103 may have a size that can accommodate multiple lengths of the device and should preferably have a size of about 22,28 cm in length with the distance between the proximal end of distal recesses 1104 and the proximal end of the proximal recess 1106 around the 6.25-13,32 see Recesses 1104 and 1106 can be any shape, but preferably rectangular.

The first linear actuator 802 is then moved to the middle position in the groove 812 in the direction of the proximal end of the frame 812. This action causes proximal movement of the first tube 102 and the proximal movement of the proximal end of the device 100 sealing, thereby pulling the sealing device 100. The first linear actuator 802 may be of any shape (lever, ball shape), but should preferably be in a form tailored to the doctor's finger. The first linear actuator 802 may be made of any material with appropriate mechanical properties, but it is preferable to use a material similar to that used in the manufacture of a calibration insert 1103. Property of the first linear by�CSOs mechanism 802 is the presence of recessed teeth formed in the upper portion of the first linear actuating mechanism 802 to secure the return of the harness 110. This property is preferred, but optional. The teeth may be any winding tract or can be of any shape necessary to create resistance for the return of harness 110 during loading, deployment or return to the original state of the device 100 sealing. Corresponding protruding teeth (not shown) may be formed in the lower surface of the latch 803 return harness. These teeth can come in gear and hold the return wiring. Other methods, well known in the art and are used to secure the bundle of small diameter, may also be used and will be described in detail below.

The first linear actuator 802 is then moved further proximally until then, until the device is loaded into the third tube 104. During this action the spring pushes 1100 first linear actuator 802 and the core of the lever 1000 management in the left wall of the chute 812 in the proximal recess 1106 in the calibration box 1103. The second tube 108 is released and is moved proximally to the sealing device 100 and the first tube 102. When the first linear fulfill�flax mechanism 802 is moved proximally, the second tube 108, the sealing device 100 and the first tube 102 slides or transferred to a third tube 104. After the first linear actuator 802 will be located in the most proximal position, the system may be again washed with a saline solution using a previously described method.

Alternative embodiments of the first linear actuating mechanism 802 shown in Fig. 12A-D. Fig. 12A shows a perspective view of an alternative first linear actuating mechanism 1108 in a fixed position harness returnable. Linear actuator 1108 structurally similar linear actuator 802, but differs in the presence of the locking ring 1110 return harness and groove 1112 return harness. Fig. 12B shows an alternative 1114 embodiment, which is made with a wheel 1116 knurled, which regulates the length of the linear actuating mechanism for ease of manipulation. The wheel 1116 knurled screws onto the threaded rod 1118, around which is wound the return wiring. Version 1114 embodiment also contains a groove 1120 return harness, through which the return wiring is routed in front of the sturdy around the threaded rod 1118. Fig. 12C shows another variant 1122 embodiment in which electrically adjustable side�ka wheel 1124 knurled, around which is wound recurrent harness, securely attached to the actuator 1122 by inserting the threaded rod 1124 in a threaded hole (not shown) in the wall of the actuating mechanism 1122. Before pulling the return of the plait around the threaded rod 1124 return harness is inserted through the slot 1126 return harness. Another option 1128 embodiment shown in Fig. 12D. Version 1128 embodiment shows a linear actuator with a cast wheel 1130 knurled. This 1130 wheel with knurled lasts a little over a linear actuating mechanism to facilitate control of a linear actuator. Return harness is inserted through the groove 1132 return harness and wrapped around the threaded rod (not shown). Cast wheel 1130 tread plate is then securely attached to the threaded rod and securely fixes the return wiring.

The deployment device 100 sealing in place of the source of the disease is shown in Fig. 9V. The first linear actuator 802 is moved distally until it stops. This movement causes the distal movement of the first tube 102 and second tube 108 inside of the third tube 104. Linear actuator 802 must then be moved to the right into the groove 812, overcoming the resistance of the spring 1100. When linear the Executive m�the mechanism 802 is moved to the right, the core of the lever 1000 control rotates on a sliding rod 1102. This action frees the linear actuator 802 from the proximal recess 1106 in the calibration box 1103. After this operation, the linear actuator 802 is further moved distally. This causes distal movement of the first tube 102 and the proximal loop 202 of the device 100 sealing. In addition, this action prevents movement of the distal end of the device 100 sealing. First tube 102 sends a device from the third tube 104 to deploy the device in place of the disease. Moving distal to the end of the chute 812, linear actuator 802 provides the full deployment of the sealing device. Specialist in the art it is clear that the implementation of the steps above could be stopped and restarted in the opposite direction at certain points, allowing optimal positioning of the device 100 sealing.

Fixation device described in the flowchart of the algorithm of Fig. 9C. The latch 803 return harness will be unfastened from the first actuating mechanism 802. The doctor controls the second linear actuator 806 attached by capturing unblocking actuating mechanism 808, feeding it forward to the middle of the frame� 810. The second linear actuator 806 may be any size or shape, but the preferred size should allow him to fit into the groove 1002 in the direction of the longitudinal axis of the frame 810. Linear actuator 806 is provided with locking actuator 808 by fitting latch. Any material attachment, such as glue or the presence of moulded construction parts, will secure attachment unlocks actuating mechanism 808 to a linear actuator 806. Materials intended for the manufacture of the second actuating mechanism 806, and the unblocking of the Executive mechanism 808 may be any material with appropriate mechanical properties, but preferably similar to those materials previously mentioned in the manufacture of components of the handle. Unblocking the actuator 808 is designed to provide a secure grip of the device by the user. Grasping can be facilitated by the presence of the projections on the sides of the locking actuating mechanism 808. These protrusions can be made of similar material as the locking actuator 808, or may be formed of a material having a high coefficient of friction or from a more suitable material, h�m medium, made of unblocking the actuator 808. These protrusions may also be manufactured in the form of a lattice, rough, textured or grooved shape in combination with the material specified above, further contributing to the capture device. These structural elements on the surface of the locking actuating mechanism 808 may also be used to aid in grasping without using challenging ledges and can be applied directly on the side surface of the second linear actuating mechanism 806. Gutter 1002 can be performed with the opportunity to have a retainer for retaining the second linear actuating mechanism 806 in the most distal position while the sealing device is unlocked. A preferred embodiment of the stopper shown in Fig. 10 and 11 and has a corrugated structure, but may also be made in the form of a mechanical stopper. Gutter 1002 may be of any length, but the preferred length must be such that is sufficient for transmission to the proximal movement across the width of the second linear actuating mechanism 806 plus approximately 3,18 see the Groove 1002 may have any shape that will allow it to accommodate the second linear actuator 806.

An alternative implementation of the second linear ISPO�enforcement mechanism 806 shown in Fig. 13A and 13C. Instead of exciting the unblocking of the Executive mechanism 808 and activating a second linear actuating mechanism 806 rotating locking actuator 1300 is grasped and rotated to unlock. Rotating locking actuator 1300 may have a gap 1302, which prevents movement forward of the first linear actuating mechanism 802. During rotation of the locking actuator 1300 performs the same actions as locking the actuator 806, shown in Figure 10.

As soon as the second linear actuator 808 will be captured, the doctor may move the second linear actuator 806 proximally. This action causes proximal movement of the third tube 104, core lever 1000 control, calibration insert 1103 and the second tube 108. The second tube 108 is moved proximally between the loops of the device. An alternative way to execute this action is the presence of torsion mechanism at the distal end of the handle instead of the second linear actuating mechanism 806. The torsion mechanism is provided with a chute that allows similar movement of the third tube 104, core lever 1000 control, calibration insert� 1103 and the second tube 108 is similar to the action of the second linear actuating mechanism 806.

Once the lock is released, the latch 803 return harness is twisted and is derived from the first linear actuating mechanism 802 and extends until the release of the reversionary harness 110 of delivery system. Return wiring 110 is attached to the latch 803 return harness at one end. Return wiring 110 may be manufactured from any material with appropriate mechanical properties, such as Kevlar®, flexible metal wire, polymers and the like. The preferred material for the manufacture of returnable harness 110 is ePTFE fiber. The latch 803 return harness can be made in different shapes and sizes. Possible the latches return harness may be in the gutter, which returns to the initial state of the linear actuating mechanism 802. In one of the layouts returnable harness is securely fixed via a chute or hole in the axis of a knurled wheel located in a linear actuator 802 and is fixed by rotation of a knurled wheel. An alternative design is the presence of the latch that captures the return wiring between the locking mechanism and the linear actuator 802, using friction. The preferred design is the presence of secure attachment returnable harness prongs fix�return of Thor harness, as shown in Figure 11.

Materials suitable for the manufacture of a latch 803 return harness, similar to those used for the frame 810 and other components of the handle. As previously mentioned, the latch 803 return bundle preferably has teeth or projections which correspond to the teeth of the linear actuator 802 to capture the return of the harness 110. The latch 803 return harness can be made in many forms to secure the return of the harness 110. The preferred configuration includes a hole through the latch 803 return harness that allows you to run through him recoil 110 wiring and tighten the knot. After twisting the lock 803 harness returnable returnable wiring 110 is removed from the delivery system by pulling.

Before performing the fourth step described in Fig. 9C, the sealing device 100 may be returned to its original state, as described in the flowchart of the algorithm of Fig. 9D. The latch 803 return harness can snap on the first linear actuator 802. This locks in place the return wiring 110. The doctor then moves the first actuator 802 in the right wall of the chute 812. The first linear actuator 802 is moved into the groove 812 to the right, compressing the spring 1100, while the core of the lever 1000�management revolves on a sliding rod 1102 to the right side of the handle. The sliding rod 1102 preferably has a round cross-section, but specialists in the art it is clear that there are many acceptable forms of cross-sections (e.g., rectangular or triangular). The sliding rod 1102 may also be made in the form of castellated spring 1400, as shown in Fig. 14A and B. the Spring could be inserted into the groove 1402 via a linear actuator, allowing you to move the linear actuator along the entire length. An alternative embodiment of a spring 1100 may be a molded spring which is an integral part 1500 of the first linear actuating mechanism 802, as shown in Fig. 15. Another variant of implementation of the spring 1100 shown in Fig. 16. In this embodiment, the spring 1600 is attached to the frame 810 and pushes the first linear actuator 802 in key positions. As mentioned above, the specialist in the art knows which relevant materials can be used for both the springs and the cast part. The first linear actuator 802 is released from the distal recesses 1104, this prevents movement of the second tube 108. The first linear actuator is moved proximally by the doctor, causing proximal movement of the first tube 102. This movement lane�comprises the proximal end of the device 100 sealing, proximally stretching device 100 and allowing him to enter into a third tube 104.

Examples

Without limiting the scope of invention examples showing the implementation and/or use different variants of implementation.

Example 1

The sealing device similar to that shown in Fig. 1, was fabricated using the following components and the build process.

Expanding polytetrafluoroethylene was obtained with the following characteristics:

the point of the beginning of boiling of methanol - 1 pound/square inch

weight/ size is 2.2 grams/sq m

longitudinal maximum load of 1.6 kg/inch

the thickness - to 0.0003 inch

tensile strength longitudinal matrix - to 92,000 pounds/square inch.

To determine the above characteristics, we used the following test methods and equipment: the start point of boiling methanol was measured by a custom-built mechanism with a base diameter of 1 inch, with a tracking speed of the load curve 0.2 psi/s, while the liquid medium consisted of methanol. The material length and width were measured with a metal ruler. Mass/area was measured using a balance (model GF-400 Top Loader Balance, ANG, San Jose A.), using a sample of 36×5 inches. Longitudinal maximum load was measured using a setup for testing of materials (MoE�spruce 5564, Instron, Grove City, PA), equipped with a weight sensor 10 kg. Length of the test part of the specimen was 1 inch, and the speed of the RAM was 25 mm/min specimen Width was 1 inch. Measurements when testing for longitudinal stretching was performed along the length of the material. The thickness was measured with calibrater (Mitutoyo Digital Indicator 547-400) in diameter at the baseinches. The values of tensile strength (MTS) of the longitudinal matrix were calculated using the following equation: Density was calculated by the formula density = mass/volume

Expanding polytetrafluoroethylene with a thin layer of FEP (fluorinated ethylene propylene) was obtained with the following characteristics: mass/area - 36.1 grams/sq. meter maximum longitudinal load - 12.6 kg/inch maximum transverse load of 0.3 kg/inch thickness - 0,0012 inch

To determine the above properties, we used the following test methods and equipment: the material was weighed on an accurate analytical balance (model GF-400 Top Loader Balance, ANG, San Jose CA.) using trial sample area 36×1 inch. The material length and width were measured with a metal ruler. The thickness of the material was measured with a digital calibration (Mitutoyo Digital Indicator 547-400) in diameter at the baseinches. M�ximalaya transverse load was measured using the installation for testing materials (model 5564, Instron, Grove City, PA), equipped with a weight sensor 10 kg sample Width was 1 inch gauge length was 1 inch, and the speed of the RAM was 25 mm/min Maximum load was measured using the installation for testing materials (Model 5564, Instron, Grove City, PA) equipped with a load cell of 200 kg. sample Width was 1 inch gauge length was 1 inch, and the speed of the RAM was 25 mm/min Measurement when tested in the longitudinal stretching was performed along the length of the material, and dimensions when tested in the transverse stretching was performed in the direction perpendicular to the length.

Distal loop was formed by obtaining a first segment of wire from drawn wire made of nitinol core with the addition of 10% platinum (Fort Wayne Metals, Fort Wayne, IN.) with a diameter of about 0.23 mm. This wire was labeled as the "first wire". The free end of the first wire was doubled, creating a loop with an open end, and this loop with the open end was inserted into the spacer. This stub was then impaled on the key Central stem. The plug has a Central hole for the placement of key Central pin and has distinguishing characteristics that allow it to stay securely fastened to the winding Chuck. Key Central pin (core�VNOM axis of about 0.51 mm, a minor axis of about 0.25 mm and a length of about 10.16 mm) was then inserted into the winding center of the cartridge. Key Central pin was made of high-strength steel Super Cobalt HSS Tool Bit, MSC#56424278, Fagersta Seco). This steel was subjected to the release according to the manufacturer's instructions at a temperature of 1475°F within one hour. Winding the cartridge and cap were made of a corrosion-resistant tool steel on its own.

The second section of such a wire was received from drawn wire made of nitinol core and tagged as "fifth wire". First, the fifth and three additional wires were tensioned by weights attached to the ends of the wires. The first wire and the fifth wire was then wound on the free end of the first wire rod one full turn.Three additional wires were placed in winding the cartridge, and all five wires were wound on the free end of the first wire at a height of approximately 1,98 mm.

The distal disc was then formed by the separation of the five wires and secure them by fastening in radial grooves around the peripheral edge of the winding of the cartridge. The radius was 15 mm. Each wire was formed by one petal of the distal disk. The radius of curvature of the petals was as large to minimize the sharp angle of bending of the wire.

TSE�Central loop was formed by combining wires and their rotation around the free end of the first wire and key Central pin at a height of approximately 1,98 mm. These wires were then separated and securely mounted in radial grooves around the peripheral edge of the winding of the cartridge, creating the proximal disk of radius 15 mm.

The proximal loop was again formed by combining five wires and winding them around the free end of the first wire and key Central pin at a height of approximately 1.98 mm. Five wires were then separated and securely mounted with metal plate made of stainless steel, is placed over the wires and fastened with screws. The free end of the first wire was then wound one turn around the post with a diameter of about 3.18 mm, made of stainless steel, and secured like other five Provolone.

The cartridge with the sealing device was then removed from the stabilizing fixture and placed in an oven (electric convection oven with forced air supply Blue MSPX), and these wires were heat-treated, as is customary in the art. The device and cartridge were then quenched in water. Fixed wires were disconnected from the mounting plate, and the device was cooled down and is disconnected from the cartridge and key Central pin. The device was then placed on a flat piece RAILS (peek), and aligned manually� the outer diameter of the distal loop. The locking loop was manually aligned to more than one full turn and stretched through the proximal and Central loop.

The device has been moved from the RAILS of the mandrel working on key core oval cross-section, of stainless steel. This core was made of smooth wire, made of steel (Ft. Wayne Metals, Fort Wayne, In.) with an oval cross-section for receiving the 45° angle of twist in a clockwise direction between the proximal loop and Central loop and the second 45° of twist in a clockwise direction between the Central loop and the distal loop.

Working the core and the device were then placed in a stabilizing device that was installed in the FEP installation for powder coating FEP (P-30, ElectrostaticTechnology, Inc., Bradford, CN) to obtain full coverage. Excess FEP powder was removed from the device. FEP was vacuumized from the locking loop, working core and buffer. Working the core and the device were removed from the stabilizing fixture, placed in a furnace and subjected to calcination to obtain the FEP coating known in the art.

Was taken hollow core with sheath (stainless steel outer diameter 35,99 mm and a length of 76.2 cm). Expanding polytetrafluoroethylene material with the width of the gap 22,22 mm was taken and loaded�n on the mechanism wraps by spiral winding. This mechanism was made on the spot for a wrap of PTFE (polytetrafluoroethylene) at any desired angle, with the desired tension and speed. The core was loaded on the mechanism of wraps, and the hollow core was overnet this material three times along the circumference. Then the core was overnet this material at an angle of approximately 8° along the length of the core. The direction of the wrap was reversible, the material was abortively at the same angle. The third and fourth layers were deposited by the same method with an offset seam lines. The core was removed from the mechanism with a wrap, placed in a furnace and subjected to firing at a temperature of 370°C for 45 minutes. The wrapped core was removed from the furnace and cooled to room temperature. Ready PTFE tube was removed from the core.

This PTFE tube was then cut to size approximately 140 mm and stretched manually to the desired length 155 mm PTFE tube was then stretched on a frame. PTFE tube was then compressed on the main loop and then compressed on the distal and proximal loops.

Loop, starting with the Central loop were then wrapped four times expanding polytetrafluoroethylene with a thin layer of FEP (fluorinated ethylene propylene). Wrapped loops were soldered in place by a soldering iron. PTFE tube was then heated at a temperature of 320°C in tech�of 3 minutes and aligned on the outer points of the proximal and distal loops. The device was removed from the core.

Example 2

The sealing device, like the device shown in Fig. 6, was fabricated using the following components and the build process.

Expanding polytetrafluoroethylene and expanded polytetrafluoroethylene with a thin layer of FEP (fluorinated ethylene propylene) is similar to the materials described in Example 1.

Distal loop was formed by obtaining a first segment of wire from drawn wire made of nitinol core with the addition of 10% platinum (Fort Wayne Metals, Fort Wayne, IN.) with a diameter of about 0.23 mm. This wire was labeled as the "first wire". The free end of the first wire was doubled, creating a loop with an open end, and this loop with the open end was inserted into the spacer. This stub was then impaled on the key Central stem. The plug has a Central hole for the placement of key Central pin and has distinguishing characteristics that allow it to stay securely fastened to the winding Chuck. Key Central pin (main axis approximately 5,79 mm, a minor axis of about 0.25 mm and a length of about 10.16 mm) was then inserted into the winding center of the cartridge. Key Central pin was made of high-strength steel Super Cobalt HSS Tool Bit, MSC#56424278, Fagersta Seco). Winding PA�Ron and cap were made of a corrosion-resistant tool steel on its own.

The second section of such a wire was received from drawn wire made of nitinol core and tagged as "fifth wire". First, the fifth and three additional wires were tensioned by weights attached to the ends of the wires. The first wire and the fifth wire was then wound on the free end of the first wire rod one full turn. Three additional wires were placed in winding the cartridge, and all five wires were wound on the free end of the first wire at a height of approximately 1,98 mm.

The device was then formed by the separation of the five wires and secure them by fastening in radial grooves around the peripheral edge of the winding of the cartridge. The radius was 15 mm. Each wire was wound on a complete revolution around the wound cartridge.

The proximal loop was again formed by combining five wires and winding them around the free end of the first wire and key Central pin at an altitude of about 1,981 mm. Five wires were then separated and securely mounted with metal plate made of stainless steel, is placed over the wires and fastened with screws. The free end of the first wire was then wound one turn around the post with a diameter of about 3.18 mm, made of stainless steel, and securely hook up to the air�linen like other five wires.

The cartridge with the sealing device was then removed from the stabilizing fixture and placed in an oven (electric convection oven with forced air supply Blue MSPX), and these wires were partially thermally processed, as is customary in the art. The device and cartridge were then quenched in water. Fixed wires were disconnected from the mounting plate, and the device was cooled down and is disconnected from the cartridge and key Central pin. The device was then placed on a flat piece RAILS (peek), and aligned manually on the external diameter of the distal loop. The locking loop was manually aligned to more than one full turn and stretched through the proximal and Central loop.

The device has been moved from the RAILS of the mandrel to the key core displacement oval cross-section, of stainless steel. This core was made of smooth wire, made of steel (Ft. Wayne Metals, Fort Wayne, In.) with an oval cross-section. The device was then partially removed from one end of the core displacement. The remote end of the device was twisted clockwise about 180° and repositioned on the core displacement. Device and the core of the movement were placed in the oven (electric convectio�Naya oven with forced air supply Blue MSPX), where these wires were heat treated, as known in the art.

The core displacement and the device were then placed in a stabilizing device that was installed in the FEP installation for powder coating FEP (P-30, ElectrostaticTechnology, Inc., Bradford, CN) to obtain full coverage. Excess FEP powder was removed from the device. FEP was vacuumized from the locking loop, working core and buffer. The core displacement and the device were removed from the stabilizing fixture, placed in a furnace and subjected to calcination to obtain the FEP coating known in the art.

Was taken hollow core with sheath (stainless steel outer diameter 35,99 mm and a length of 76.2 cm). Expanding polytetrafluoroethylene material with the width of the gap 22,24 mm was taken and uploaded to the mechanism wraps by spiral winding. This mechanism was made on the spot for a wrap of PTFE (polytetrafluoroethylene) at any desired angle, with the desired tension and speed. The core was loaded on the mechanism of wraps, and the hollow core was overnet this material three times along the circumference. Then the core was overnet this material at an angle of approximately 8° along the length of the core. The direction of the wrap was reversible, with materialistically at the same angle. The third and fourth layers were deposited by the same method with an offset seam lines. The core was removed from the mechanism with a wrap, placed in a furnace and subjected to firing at a temperature of 370°C for 45 minutes.The wrapped core was removed from the furnace and cooled to room temperature. Ready ePTFE tube was removed from the core.

The ePTFE tube was then cut to size approximately 140 mm and stretched manually to the desired length 155 mm ePTFE Tube was then stretched on a frame. The ePTFE tube was then compressed on the distal and proximal loops. The loops were then wrapped with ePTFE thin layer of FEP (fluorinated ethylene propylene) four times. Wrapped loops were soldered in place by a soldering iron. This ePTFE tube was then heated at a temperature of 320°C for 3 minutes and aligned on the outer points of the proximal and distal loops. The device was removed from the core.

Example 3

Arm assy, similar to the handle shown in Fig. 8 was manufactured using the following components and the build process.

Components to build arm were produced by injection molding. Parts have been manufactured by company Contour Plastics (Baldwin, WI) using Lustran® 348. This material was suitable for use in medical devices and it has stated breaking strength 48,2 MPa and modulus of elasticity at rastaje�and 2,62 GPa. Nine parts were manufactured according to the method of injection molding using Lustran® 348. The data portion includes a second linear actuator, the retainer strip wash, the first linear actuator, the latch return harness, the core of the control lever, the left wall of the frame, the alignment insert, the right wall of the frame and locking the actuator.

Other materials necessary for Assembly of the handle, were purchased. Was ordered a tube of the catheter is formed with the overlay process known in the art, (Teleflex Medical, Jaffrey, NH) internal diameter. 0,048 mm and an outer diameter of 0.33 mm and with a platinum-iridium marker layer placed near the distal end of the tip. The main part of the catheter tube was a tube made of Pebax® 7233 with liner PTFE braided stainless steel (65 PPI), and the highest point of the distal 20,32 mm catheter tube contained 6333 Pebax® (inner diameter of 0.027 mm and the outer diameter 0,033 mm) and the arc at the distal end (radius 39,98 mm). Wire guide wire of the catheter formed by the laser was placed in proximal marking layer catheter tube. Wash the gasket or the gasket is U-shaped cross-section, made of silicone (depth 22,99 mm, tapered inner diameter from 2,89 mm to 1.85 mm, Kononovich�th inner diameter from 6,71 mm to 7.75 mm) was ordered from Apple Rubber of Lancaster, NY. Was taken the flushing port (Merit Medical, South Jordan, UT), with approximately six-inch flexible tube made of PVC (polyvinyl chloride), with female Luer lock connection type outside diameter of 3.18 mm. Cyanoacrylate adhesive instant adhesion was supplied from our own resources. The proximal part of the type Hypotube made of stainless steel, were ordered from Small Parts, Inc. (the outer diameter of 1.45 mm, the inner diameter of 1.30 mm, a length of 30.48 cm). Sliding rods (PTFE coated proximal Hypotube section, type, outer diameter 3.18 mm, inner diameter of 1.65 mm, length 33,02 cm) were purchased from Applied Plastics. Spring management (PTFE-coated flat spring, made of stainless steel, thickness 0.10 mm, the smallest flange length is 5.33 mm, overall length flange 10,11 mm, total length 15.88 mm) were ordered from Incodema of Ithaca, NY.

The remaining components were supplied from our warehouse or have been manufactured in-house. All trehproudnyi tubes were made of Pebax® 7233 with 20% barium sulfate. Both trehproudnyi tube had an outer diameter of 0.25 mm. One trekhprovodnaya tube had gaps round shape with two internal diameters of 0.035 mm and an inner diameter of 0.15 mm. One trekhprovodnaya tube had one lumen with an oval cross section with two internal diameters of 0.036 mm and an inner diameter 0,127×,07 mm. Working the core is made of stainless steel and coated with PTFE (polytetrafluoroethylene), were manufactured on our own production. One working core had a cross-sectional shape that transitions from a round shape (the outer diameter 0.16 mm) oval (outer diameter of 0.14×0.07 mm). PTFE-coated wire, made of stainless steel of an external diameter of 0.03 mm, was supplied with own warehouse. Standard Luer lock fittings type were obtained from our own warehouse. Extruded SLATS (peek), a second pipe with an oval cross-section an outer diameter of 1.27×0.69 mm was obtained from its warehouse.

The first tube was manufactured as follows. One trekhprovodnaya extruded tube with the lumen round shape was obtained. Another trekhprovodnaya extruded tube was obtained with a single lumen with an oval cross-section. Working the core, made of stainless steel and having a cross-section changes from circular (outer diameter 1.52 mm) oval (outer diameter of 1.39×0.81 mm diameter), was also obtained. Both extruded tubes were loaded in the core, which was inserted through a wide opening on both tubes. Two small wires made of stainless steel and PTFE, were inserted through small holes in both estudiaban Tr�bkah. The core and the tube was inserted into the RF (radio frequency) head (inner diameter 2,51 mm, length of 4.45 mm) made of D2 tool steel. The connection of the two catheters were placed in the center of the RF head. RF head and the core were placed in the middle of the RF coil high frequency welding machine (Hot ShotI, Ameritherm Inc., Scottsville, NY) and is welded, as is well known in the art. When the components were melted, pressure was applied to each end of the extruded tubing to connect them. The head was then cooled compressed air and was impaled detail, made of Pebax®. Extruded tube and head were extracted from high-frequency welding machine, and extruded tube was removed from the head. Working the core and wire gaps were removed from the extruded tube.

The second tube can be put lubricating coating. Silicone anti-adhesive lubricant (Nix StixX-9032A, Dwight Products, Inc., Lyndhurst NJ) was sprayed about 30 cm of distal second tube and then dried at room temperature under a ventilation device.

Pre-Assembly of the third tube was carried out as follows. The catheter tube was cut in half with a razor approximately 6.35 cm from the proximal end of the catheter in the presence of a�. Covered and covering linear connector Lyaskovo type (Qosina, Edgewood, NY) were taken and drilled with an internal diameter of 3.45 mm. the UV curing Adhesive (Loctite 3041) was applied to the ends of the bisected catheter tube, and were joined drilled fittings Lyaskovo type. The adhesive was block is hardened according to the manufacturer's instructions, and fittings Lyaskovo type were connected by screws.

Pre-Assembly of the second linear actuating mechanism was carried out as follows. Were taken the second linear actuator, the flushing port, the retainer strip wash and silicon wash strip. Wash the gasket was inserted into the end of the second actuating mechanism of the U-shaped part washing the gasket in the distal direction. The retainer strip wash was attached to the upper portion of the inner side of the second actuating mechanism. Cyanoacrylate glue was applied over the anchor strip to hold the retainer strip in place. The flushing port was placed in the hole in the second linear actuator, and a UV curing adhesive was applied and block is hardened according to the manufacturer's instructions.

Was received first tube, and cyanoacrylate glue was applied to the outer p�the surface of circular cross-section of the inner diameter of the catheter strip of 2.54 cm from the end. Then into the distal end of the control Shuttle was inserted into the catheter so that the catheter was located flush with the rear portion of the control Shuttle. The catheter was oriented so that the two smallest of the lumen were horizontal and were on top of a round cavity. The latch return harness was recorded on the control Shuttle.

Pre-Assembly of the second tube was performed as follows. Four-inch cut nitinol wire with a diameter of 0,033 mm was inserted into the second tube is manufactured by extrusion. A second pipe is manufactured by extrusion with an inserted wire, was inserted into the detail of the Hypotube. The distal end of the Hypotube be compressed manually three times.

The distal end of the first tube is extended through the upper part of the core of the control lever and through the upper part of the hole at the distal end of the core of the control lever. The distal end of the second tube is extended into the proximal end of the control catheter. The second tube was inserted in the first tube approximately 4 inches details Hypotube, protruding from the end of the control catheter. Cyanoacrylate glue was applied to the proximal end of the Hypotube for a distance of about 12.7 mm. The segment was inserted into the hole in the proximal end of the core of the control lever� flush with the rear of the core of the control lever. The distal end of the first tube was stretched at the proximal end of the second linear actuator. The second linear actuator was displaced to the maximum in the opposite direction on the control catheter.

Then the calibration insert was inserted into the left wall of the housing. Calibration insert was oriented so that the groove in the calibration box came to orienting the ledge in the left wall of the housing. Pre-assembled catheter was placed in the left part of the body so that the core of the control lever fit in the calibration insert, and a second linear actuator walked into the groove in the distal end of the left side of the hull. The sliding rod was inserted through the holes in the calibration insert, the core of the control lever, the control hook the second linear actuator. The sliding rod has been manufactured so that it rests on two supports in the left part of the body. The control spring was inserted into the right side of the housing, so that it came to the opposite teeth. The right part of the body was then placed in the left part of the housing and the two parts were connected. Two screws (No. 4-24 x1/2inch with plokhotnichenko head) were inserted into the existing holes in the left side of the hull and screwed Locking actuator was snapped on the right foot of the second linear actuating mechanism with a minor amount of cyanoacrylate adhesive for secure attachment.

A second linear actuator that controls the Shuttle and the core of the control lever was moved forward to their maximum positions. The second linear actuator was retracted and then returned to its forward position. The distal end of the first tube was cleaned manually with a blade on 1.27 mm from the tip of the third tube. Calibration box was pushed all the way forward.

A second pipe was cleaned manually using a blade at a length of about 0.76 mm from the upper distal end of the control catheter. Was taken about a four-inch cut notinvolve wire (diameter 0.30 mm). Cyanoacrylate glue was applied to the tip of the second tube with the use of an elongated applicator. Nitinol wire was inserted into the tip of the latch, and another cut nitromojo wire length of about 2 mm was inserted into the second tube. Cyanoacrylates block is hardened glue was.

The second linear actuator was moved backward, and the control catheter was extruded out of the groove. The groove had a width approximately equal to the width of the small axis of the oval lumen of the catheter. For cutting the end portion of the trough approximately 19,05 mm were used blade. The second linear actuator and calibration insert were then moved to the forward position.

Were taken to be repaid�wide wiring length of approximately 3.05 m (PTFE filament outer diameter 0.25 mm) and mailowy cord length 1.52 m (outer diameter 0.15 mm). Nitinol wire was inserted into one of the gaps of 0.04 mm in the first tube and stretched before his appearance in the handle. For grabbing the wires and pulling out of the groove in the handle was used micropine.Pigtail length of about 76.2 mm protrudes from the distal end of the control catheter. Loop was formed in the wire by inserting the free end into the same lumen at the distal end of the control catheter. Cut the return wiring length of about 76.2 mm and then was extended through the finished loop. Nitinol wire is routed through the catheter until the return of harness in the handle.

Received the sealing device. The needle normally used for sewing was used to return the harness, and the needle was inserted through the PTFE package opposite the fixing device loop and through the lumen of the proximal loop of the sealing device. Nitinol wire was then routed via the remaining free space of the lumen in the first tube the size of 0.04 mm with loop end of the wire, localized distally. The needle was displaced from the return wiring, and wiring is routed through the loop on the nitinol wire. Return wiring was then routed through a catheter in the manner described earlier.

Managing the Shuttle has been moved back by approximately 12.7 mm. the Second tube is then b�La stretched across the hinge device. Was used micropine to capture the return of the harness and pulling it to the outer side of the handle. A loop was formed at the site of small diameter nitinol wire. This loop was inserted through the opening in the distal portion of the upper part of the control Shuttle.

Return wiring is routed through the loop and pulled out through the opening in the distal portion of the control Shuttle. The latch return harness was removed from the Manager of the Shuttle, and one free end of the reversionary harness was inserted through the hole in the locking mechanism of the return wiring from the bottom. Four knots were tied into a bundle. The excess harness was cut by hand and the latch return harness was returned to the control Shuttle.

Remaining free of recurrent harness was stretched to alleviate sagging. The remaining free end of the return wiring was inserted into the hole in the front upper part of the control Shuttle. Return the harness was stretched prior to tension, and was recorded the latch harness returnable. This harness was manually cropped to a size of approximately 20,32 cm

A second pipe was flared by use of a soldering iron with a pointed tip and heated to about 500°F. soldering tip was inserted into the second tube until its expansion approximately 1.39 mm in diameter. The locking hinge device�e was chilled.

1. The sealing device containing:
stretchable frame containing multiple wires, each of which extends from a proximal end to a distal end of the frame;
the first and second segments of each of the plurality of wires forming the coiled proximal loop and a distal loop, respectively, and the multitude of wires that form the proximal disc and distal disk when deploying the sealing device,
the proximal disk and the distal disc is located between the proximal and distal loops,
and each wire of the plurality of wires forms a corresponding proximal petal disc and a corresponding distal lobe of the disk;
and the petals form a zone of overlap and unsupported sections,
and a sealing element that at least partially encapsulates the stretchable conductive frame.

2. The device according to claim 1, wherein the sealing device is made self-centering during deployment.

3. The device according to claim 1, wherein the stretchable frame further comprises a coiled intermediate loop, formed by a multitude of wires and located between the proximal disk and distal disk.

4. Apparatus according to claim 3, wherein the sealing element closes the proximal and distal d�ski and proximal the distal and intermediate loops.

5. Apparatus according to claim 1, wherein the stretchable wire frame includes at least 5 wires.

6. The device according to claim 1, wherein the sealing element comprises a material selected from the group consisting of polyester, polyethylene, polypropylene, fluoropolymer, polyurethane, silicone, nylon and silk.

7. Apparatus according to claim 6, wherein the fluoropolymer includes polytetrafluoroethylene.

8. The device according to claim 7, wherein the polytetrafluoroethylene contains stretchable polytetrafluoroethylene.

9. The device according to claim 1, wherein the set of wires includes nitinol.

10. The device according to claim 1, wherein the sealing element is attached to lots of wires.

11. The device according to claim 1, further comprising a distal buffer located distally relative to the distal loop.

12. The device according to claim 11, further comprising a locking loop.

13. The device according to claim 1, wherein multiple wires are helically from the proximal end to the distal end.

14. The device according to claim 1, wherein at least one of the loops is formed in a noncircular shape.

15. The device according to claim 10, wherein the sealing element is attached to lots of wires by an adhesive.

16. The device according to claim 15 in which the adhesive contains FEP.

17. The device according to claim 9, in which Latino� contains 10 wt.%, platinum.

18. The device according to claim 17, wherein the nitinol is totim a nitinol core.

19. The device according to claim 1, wherein the first part of the petals define the outer diameter of the proximal disk.

20. The device according to claim 19, in which the second part of the petals define the outer diameter of the distal disk.

21. The device according to claim 3, in which the intermediate loop includes a portion of each wire of the plurality of wires in a looped configuration.

22. The device according to claim 1, wherein the neighboring petals proximal disk overlap.

23. The device according to claim 22, in which parts adjacent petals of the distal disk overlap.

24. The device according to claim 13, further comprising a distal buffer located distally relative to the distal loop.

25. The device according to claim 24, further comprising a locking loop.



 

Same patents:

FIELD: chemistry.

SUBSTANCE: invention refers to medicine, namely surgery, and can be used for treating aseptic pancreonecrosis. Intra-organic pulseless pancreatic segments are localised and removed. To cover the pancreas, a greater omentum is incised into two portions - 1/3 from the left and 2/3 from the right up to a base of the greater omentum. Segments with pulse oscillation amplitude not less than 3.0 mm in the left 1/3 of the greater omentum and not less than 2.0 mm in the right 2/3 of the greater omentum are localised. The left portion in the distal segment is anchored with U-sutures to peripancreatic subcutaneous fat, whereas the right portion in the distal segment is anchored to a right hepatic lobe.

EFFECT: method enables arresting the disease progression and preventing infected pancreatic necrosis, improving pancreatic tissue blood supply by detecting the intra-organic pulse, removing all necrotic portions of the pancreas and using the greater omentum to cover the pancreas.

3 dwg, 2 ex

FIELD: medicine.

SUBSTANCE: distal pancreas resection is performed. That involves transecting a parenchyma to the right from a superior mesenteric vein. That is followed by a resection of an anterior surface of the pseudocysts of the head of pancreas. A Roux pancreatocystojejunoanastomosis with isolated enteric loop is created.

EFFECT: reduced intraoperative injuries and risk of postoperative complications, lower extent of the operation, preserved portion of the pancreatic parenchyma and physiological passage of food and bile in the gastrointestinal tract by the distal pancreas resection and created pancreatocystojejunoanastomosis with the cyst walls and the anterior surface of the head of pancreas.

1 ex

FIELD: medicine.

SUBSTANCE: invention refers to systems for applying a filling material onto a working surface and can be used for applying a multicomponent compound, such as a surgical filling material for a tissue mass. A mixture feed device comprises a Luer mandrel sub-assembly, a cannula and a nozzle atomiser sub-assembly. The Luer mandrel sub-assembly is formed to contact at least two containers and forms the first and second fluid pipes of the mandrel for facilitating the flow of the first and second components. The cannula comprises the first and second cavities carrying the fluid. Each cavity is fluid connected to one of the first or second fluid pipes of the mandrel. The nozzle atomiser sub-assembly is arranged at the end of the cannula and involves at least a part of a nozzle insert placed into a nozzle cap. The nozzle cap has an end wall with an outlet therein. The nozzle insert and nozzle cap form at least three feed channels and are configured to limit at least three fluid passages in three respective feed channels. Each of the three feed channels is fluid connected to the fluid passage.

EFFECT: more effective mixing of the components, prevented cross-contamination of the components and facilitated fluid feed.

12 cl, 25 dwg

FIELD: medicine.

SUBSTANCE: invention refers to traumatology and orthopaedics and is applicable for joint drainage in revision endoprosthesis replacement. A drain tube is inserted into a wound with implanting a bone cement spacer containing an antibiotic. Within the first 24-48 postoperative hours, the fluid content is actively gradually evacuated from the postoperative wound every hour for 10-15 minutes.

EFFECT: method enables increasing the antibacterial effect.

FIELD: medicine.

SUBSTANCE: invention refers to medicine, namely to otorhinolaryngology, and can be used in myringoplasty, for repairing partially lost anatomic structures, such as tympanic membrane. The surgery is performed with local or general anaesthesia. A tympanic membrane defect is closed with a thinned prepared alloplant in the form of an allogeneic cartilage plate. Before implanting, the alloplant is fragmented up to 0.2-0.3 mm thick and 0.8-0.9 cm in diameter that is followed by placing the plate into a bottle with a fixing fluid. The final stage of the operation involves placing the alloplant on the edges of the tympanic membrane defect. The cartilage plate is supposed to be more by 1.0-1.5 mm in size with the plate edges to be ovelapped with the acoustic meatus skin. The acoustic meatus is packed.

EFFECT: method provides the reliable fixation of the alloplant, preventing its postoperative dislocation and retraction, audiological characteristics of the alloplant as close to the characteristics of the normal tympanic membrane as possible, the absence of implant rejection and pronounced immune response, proteolytic enzyme stability, necessary rigidity of the cartilage plate, reduced length of the intervention, the absence of a cosmetic auricle defect.

1 dwg

FIELD: medicine.

SUBSTANCE: surgical management of colon cancer is required in low colonic obstruction. A midline laparotomy and abdominal organs inspection is followed by colon mobilisation. A colonic segment with a tumour is resected. The segmented intestine is decompressed with an electric suction machine. The rectal stump is stitched with a stapling apparatus. A superposed segment of the segmented intestine is mobilised to be brought down. A tunnel is formed behind the rectal stump from the side of the anus as close as possible to the oral end of the stump. A hole is formed along the posterior wall with an electric knife and used to bring down the mobilised segmented intestine by means of a guide. The intestine is fixed to the hole borders with four stitches. The excessive intestine is brought out through the anus and fixed to the perineal skin. A dioxidine solution is administered into the abdominal cavity. The rectal stump is daily washed with antiseptic solutions until the excessive brought out intestine is dissected away on the 10-14th day.

EFFECT: method enables applying the primary stitch-free colorectal anastomosis, requires no rehabilitation stage of treating colon cancer by the natural formation of the anastomosis and prevention of its leakage; it also reduces the length of disability and improves the patient's quality of life.

1 ex, 2 dwg

FIELD: medicine.

SUBSTANCE: axial line of two enclosing incisions is marked by connecting the centres of outer mouths of fistula sequentially from up to down by a wavy line. That is followed by making two wavy enclosing incisions parallel with the axis: right and left at 20 mm from the axial line. The left incision starts 15 mm above the proximal outer mouth of fistula, and ends 15 mm below the distal outer mouth of fistula, whereas the right incision starts at the level of the proximal outer mouth of fistula and ends at the level of the distal outer mouth of fistula. Thereafter, RPF is excised in the radial direction. Two L-sutures relaxation incisions are made. The upper relaxation incision originates from the point at the beginning of the right enclosing incision and extended to the point at the beginning of the left enclosing incision and 20 mm further, turned at a right angle 25 mm upwards, and an upper triangular adipocutaneous flap is formed. The lower relaxation incision originates from the point at the end of the left enclosing incision and extended to the point at the end of the right enclosing incision and 20 mm further, turned at a right angle 25 mm downwards, and a lower triangular adipocutaneous flap is formed. That is followed by closing a wound defect by adipocutaneous repair by shifting the formed upper and lower triangular adipocutaneous flaps onto the wound defect and fixing them with interrupted sutures. The lower edge of the upper adipocutaneous flap is fixed to the right enclosing incision, and its upper edge - to the left enclosing incision. The lower edge of the lower adipocutaneous flap is fixed to the left enclosing incision, and its upper edge - to the right enclosing incision; thereafter, the wavy s are closed.

EFFECT: more effective surgical management of recurrent pilonidal fistulas, reduced number of complications and recurrences and improved aesthetic effect of the operation.

1 ex

FIELD: medicine.

SUBSTANCE: own finger artery, dorsal vein and own finger nerve of the fifth finger are cut and bandaged. A common finger artery of the transplant is sutured with own finger artery of the third finger stump. The dorsal vein of the transplant is sutured with the dorsal vein of the stump. Own finger nerve of the transplant is sutured with own finger nerve of the stump.

EFFECT: method improves results of treatment due to the correspondence of dimensions of the transplanted finger vessels to the dimensions of the vessels of the recipient area.

5 dwg

FIELD: medicine.

SUBSTANCE: tumour is removed by a laryngectomy within the boundaries of health tissue together with an underlying part of a thyroid cartilage. The upper and lower parts of the thyroid cartilage not involved into the tumour process are presented on the involved side in the form of horizontal plates 6.0-8.0 mm wide. A skin flap is cut out on the neck 0.4 cm more than the width of the created larynx defect, while its length is supposed to be equal to the one of the defect. The skin flap is thrown over the preserved fragments of the thyroid cartilage. That provides restoring the removed part of the larynx. The flap is anchored with single sutures to the intact mucosa of the preserved parts of the larynx along the perimeter of the defect. A lumen of the newly formed larynx is packed. A laryngostoma and a tracheostoma is formed. A tracheostomic tube No. 5-6 is inserted into the tracheostoma. A dressing is applied.

EFFECT: method provides performing the functionally conservative surgery, preserving the natural respiratory and vocal functions, reducing postoperative inflammatory complications, preventing a laryngeal lumen stenosis and rehabilitating its functions, reducing a rate of intraoperative injuries and a length of staying in hospital, improving the patient's quality of life, making it possible to start a radiation therapy by preserving the intact upper and lower parts of the thyroid cartilage and repairing a laryngeal side wall with the thrown-over skin flap cut out on the neck.

4 dwg, 1 ex

FIELD: medicine.

SUBSTANCE: oesophagus is separated. Oesophageal wall injuries are detected. A through drain tube with perforations is delivered through the defects in the oesophageal walls. One through drain tube is delivered through two oesophageal defects simultaneously. The drain tube holes are placed in the oesophageal lumen. The oesophageal defects are closed up to the drain tube. The tube is delivered through pedicle grafts pre-excised of proper tissues. The above grafts are used to fasten suture lines on the oesophagus. The drain tube - through counter apertures.

EFFECT: method for transoesophageal through drainage reduces the length of treatment by adequate sanitation of a mediastinal septum and oesophageal defect and conditions for their independent healing.

1 dwg

FIELD: medicine.

SUBSTANCE: method involves applying one or two parallel through draining tubes having lateral perforations. Flow lavage of the retroperitoneal space with antiseptic solutions is carried out via the perforations at room temperature and cooled solutions are administered concurrently with vacuum suction. Omental bursa is concurrently drained using the two parallel through draining tubes. Flow lavage of the omental bursa is carried out using these tubes.

EFFECT: enhanced effectiveness of treatment in healing pyo-inflammation foci.

5 cl, 1 dwg

FIELD: medicine.

SUBSTANCE: method involves carrying out left-side laparophrenotomy. Esophagus and stomach stump extirpation is carried out. Large intestine is conducted in the posterior mediastinum. Distal end-to-end anastomosis of transplant and the duodenum is created using atraumatic sutures.

EFFECT: enhanced effectiveness of plastic repair in the cases of resected stomach cancer.

1 dwg

FIELD: medicine.

SUBSTANCE: method involves carrying out hernia removal in intralaminar way. Posterior longitudinal ligament defect is covered with Tacho-Comb plate after having done disk cavity curettage. Subcutaneous fat fragment on feeding pedicle is brought to dorsal surface of radix and dural sac.

EFFECT: enhanced effectiveness of treatment; reduced risk of traumatic complications.

1 dwg

FIELD: medical engineering.

SUBSTANCE: device has thread knitted into fabric. Fabric for tamponing wound and removing it by pulling the thread is connected to internal film surface with collagen gel. The film overlaps fabric area and has opening equal to two-lumen draining tube canal connected to external film surface and having one canal longer than the other one. Distal end of the shorter canal is connected to opening in the film and distal end of the longer one is brought outside of its boundary. Proximal ends are connectable to vacuum receiver. Fabric thread is brought to the shorter canal from the internal wall and fixed on the external shorter canal wall.

EFFECT: reliability in stopping hemorrhages and retaining patient mobility.

2 dwg

FIELD: medicine.

SUBSTANCE: method involves applying sling urethropexy. Pneumoextraperitoneum is created by means of trocar introduced under the pubis. Then, longitudinal perineotomy and paraurethral tissue dissection is carried out to the right and to the left towards the descending branches of pubic bones to pelvic fascia. The urethra is moved to its left. TVT needle is introduced under descending branch of pubic bone to the right of the urethra. The pelvic fascia is perforated in away that needle tip enters retropubic space laterally with respect to the prostate and in front of the urinary bladder. The needle is brought along the posterior pubic bone surface and exits via abdominal wall outside pulling one end of polypropylene ribbon. The like manipulations are accomplished at the left side to form a loop around the urethra tightly adjacent to bulbocavernous muscles. Final ribbon fixation is carried out after having eliminated the pneumoextraperitoneum and having removed the trocar.

EFFECT: simplified operation; avoided intra- and postoperative complications and recidivation.

FIELD: medicine.

SUBSTANCE: method involves evaginating duodenum stump with polypotomy loop into organ wall followed by electric surgical excision.

EFFECT: stable hemostasis; provided aseptic conditions in sealing the stump.

3 dwg 1 tbl

FIELD: medicine.

SUBSTANCE: method involves carrying out rein performing pancreaticoduodenal resection. Cholecystoenteroanastomosis is built. Anastomosis application takes place between the right hepatic duct and gallbladder neck near its flexure.

EFFECT: prevented biliary hypertension.

FIELD: medicine, surgery.

SUBSTANCE: one should perform incisions of parietal peritoneum by leaving 2 cm against inferior and superior edges of patient's pancreas being of 1.5 cm length to apply them in checkered order for the purpose to prevent vascular lesion.

EFFECT: higher efficiency of decompression.

1 ex

FIELD: medicine, surgery.

SUBSTANCE: the method is applied for the purpose to correct combined deformations of external nose due to oral-vestibular operative access. The method deals with dissecting mucosal membrane and periosteum in oral vestibule followed by separating soft tissues of the upper lip. Then one should perform internal incision along the edge of alar cartilages to connect two incisions together. Then comes final tissue separation at subsequent correction of the shape, size of external nose structures and its septum. The method enables to achieve wide access to all the structures of external nose and provide optimal cosmetic result.

EFFECT: higher efficiency of correction.

4 dwg

FIELD: medicine, urology.

SUBSTANCE: the present innovation deals with affecting the sclera and applying deformation-correcting sutures at the background of medicinal erection. Along lateral surfaces of cavernous bodies symmetrically from both sides one should make incisions of scleral surface layer. Then comes manual derotation, moreover, at the side of derotation incision's lower edge should be shifted downwards and backwards, its upper edge - upwards and to the front, and at contralateral side the lower edge is shifted downwards and to the front, and the upper edge - upwards and backwards. After manual penile derotation one should apply sutures onto the edges of dissected scleral layer in incision area by shifting needle's puncture out towards the side being opposite to shift direction of the lower edge against incision's perpendicular axis. The quantity of incisions should be calculated by the following formula: Q = N/n, where Q - the desired quantity of incisions, N - the angle of total initial rotation, n - the angle of derotation achieved after applying sutures onto the first pair of incisions. The method enables to decrease the risk for development of either new or residual penile deformation in postoperational period.

EFFECT: higher efficiency of correction.

3 dwg, 1 ex

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