CN115005906B

CN115005906B - Vascular closure device

Info

Publication number: CN115005906B
Application number: CN202210629833.9A
Authority: CN
Inventors: 张健; 张瑾; 马彩霞; 张永凯; 程海波; 杨晨
Original assignee: Shanghai Jinkui Medical Devices Co ltd
Current assignee: Shanghai Jinkui Medical Devices Co ltd
Priority date: 2022-06-02
Filing date: 2022-06-02
Publication date: 2023-02-24
Anticipated expiration: 2042-06-02
Also published as: CN115005906A

Abstract

The utility model provides a vascular closing device, includes the diaphragm, has the closed area who corresponds the damaged position of blood vessel on the diaphragm, and vascular closing device is still including the setting element of locating closed area department, the setting element include with the spacing portion of closed area interval arrangement and be connected spacing portion and closed area's connecting portion, connecting portion are used for passing the damaged position of blood vessel so that spacing portion and diaphragm can butt respectively in the inside and outside both sides of vascular pipe wall. When the blood vessel puncture needle is used, the diaphragms connected through the limiting parts and the connecting parts are respectively abutted to the inner side and the outer side of the wall of a blood vessel, and the static friction force and the clamping force applied to the wall of the blood vessel through the limiting parts and the diaphragms and the connecting parts penetrating through damaged parts of the blood vessel realize the position limitation of the diaphragms. Therefore, the defect that the damaged part of the blood vessel cannot be closed effectively due to the displacement of the diaphragm is overcome. Simultaneously, the limiting part arranged in the blood vessel can form certain separation to blood flow, and the diaphragm is prevented from bulging outwards under the action of blood pressure to cause blood to flow out.

Description

Vascular closure device

Technical Field

The invention relates to the field of medical instruments, in particular to a vascular closure device.

Background

The number and variety of minimally invasive procedures continues to increase, in part because such techniques have more immediate advantages over more traditional, but highly invasive, surgical procedures. For example, endoscopic surgery uses an endoscope inserted through one or more small incisions to diagnose and treat disease. In particular, endovascular surgery can access many areas of the body, such as the heart, through major blood vessels. Typically, this technique involves the percutaneous introduction of a surgical instrument into a blood vessel, such as the femoral artery. Currently emerging percutaneous endovascular procedures include aortic valve replacement, mitral valve repair, tricuspid valve replacement, and abdominal and thoracic aneurysm repair. Other procedures requiring access to the femoral artery include coronary, carotid and cerebrovascular angiography procedures. Still other procedures may require intravenous access, such as intravenous antibiotic therapy, or long-term intravenous feeding to obtain nutritional support. Other instances of minimally invasive surgery include endoscopic procedures based on natural orifices, such as transgastric, transvesical, and transcolonic approaches.

One key feature of these minimally invasive surgical procedures is the creation of a temporary path to the surgical site, usually an incision or a dilated perforation. For example, in emerging percutaneous endovascular procedures, incisions, punctures, or perforations are made as temporary pathways into the target site. Various commonly used medical devices (e.g., surgical sheaths, guide wires, and catheters), as well as specialized medical devices (e.g., balloon catheters and stents), are inserted through the access site to form temporary pathways.

Currently, these access sites (e.g., large incisions, punctures, or perforations) are typically created after the vessel is cut in a minimally invasive procedure, which is very invasive at the access site and is accompanied by complications. Thus, the rapid development of percutaneous, minimally invasive endovascular surgery (such as interventional radiology and cardiology) has resulted in the need for instruments to close off the access site of the temporary access.

The existing apparatus for closing temporary access on blood vessel is a blood vessel closing device, the existing blood vessel closing device is usually a membrane covering the damaged part of the blood vessel to close the blood vessel, the existing blood vessel closing membrane is generally covered and fixed on the damaged part of the blood vessel by a surgical suture method, the operation wound is large, and the suturing time in the operation is long. If the blood retention time of the large blood vessel is too long, the large blood vessel can cause great damage to a patient and is not easy to recover.

Therefore, a membrane fixed on the surface of a blood vessel in a fitting manner is provided to solve the defects caused by the suture method, but the membrane has the following problems: the diaphragm is easy to displace, so that blood flows out from the gap between the diaphragm and the blood vessel, and the closing effect is not ideal.

Disclosure of Invention

The invention aims to solve the technical problems that in the prior art, the product design is complex, the operation is inconvenient, the membrane is easy to displace, and blood is easy to flow out under the pressure of the blood, and provides a vascular closure device.

The invention solves the technical problems through the following technical scheme:

the utility model provides a vascular closing device, includes the diaphragm, have the closed area who corresponds the damaged position of blood vessel on the diaphragm, vascular closing device is still including locating the setting element of closed area department, the setting element include with the spacing portion of closed area interval arrangement and connection the connecting portion of spacing portion and closed area, connecting portion are used for passing the damaged position of blood vessel is so that spacing portion and diaphragm can the butt respectively in the inside and outside both sides of vascular pipe wall.

When the blood vessel wall limiting device is used, the diaphragms connected through the limiting parts and the connecting parts are respectively abutted to the inner side and the outer side of the blood vessel wall, and the static friction force and the clamping force applied to the blood vessel wall through the limiting parts and the diaphragms and the connecting parts penetrating through damaged parts of the blood vessel realize the position limitation of the diaphragms. Therefore, the defect that the damaged part of the blood vessel cannot be closed effectively due to the displacement of the diaphragm is overcome. Simultaneously, the limiting part arranged in the blood vessel can form certain separation to blood flow, and the diaphragm is prevented from bulging outwards under the action of blood pressure to cause blood to flow out.

Preferably, the membrane is coated with an expandable gel at the surface facing the blood vessel, the expandable gel being capable of expanding upon absorption of a liquid to occlude the vascular lesion.

Through adopting such design, appear the gap between diaphragm and the vascular wall and cause blood to flow from gap department when, this expandable gel can contact and absorb blood with blood to volume inflation is in order to seal this gap, and then seals this damaged position of blood vessel, makes blood can not flow from damaged position of blood vessel department, and closed effect is better.

Preferably, the expandable gel is coated on the whole surface of one side of the membrane facing the blood vessel, or the expandable gel is arranged on the surface of one side of the membrane facing the blood vessel in a ring shape, and the damaged part of the blood vessel can be correspondingly positioned in the ring formed by the expandable gel.

The best sealing effect can be realized by coating the expandable gel on the whole surface of the side, facing the blood vessel, of the membrane, and the materials can be saved while the sealing effect is realized by annularly arranging the expandable gel on the surface of the side, facing the blood vessel, of the membrane.

Preferably, the diaphragm has a curvature capable of being adapted to the outer surface of the blood vessel, the diaphragm is made of a material capable of maintaining the shape of the diaphragm, and/or the limiting portion is in the shape of a sheet or a rod or a narrow band or a net, the limiting portion is flexible and bendable and capable of generating a restoring force for restoring the limiting portion when bent, and/or the connecting portion is in the shape of a rod, and the connector is connected with the diaphragm through a snare or a nut or a barb passing through a connecting hole in the diaphragm.

Preferably, the membrane has a curvature that is adapted to the outer surface of the blood vessel.

Therefore, the membrane can be better attached to the outer surface of the blood vessel, and blood is better prevented from leaking out of the gap between the membrane and the blood vessel.

Preferably, the diaphragm is made of a material capable of maintaining the shape of the diaphragm.

When the device is used, a guide wire is inserted into a blood vessel to manufacture a passage communicated with the damaged part of the blood vessel, then a sheath tube is inserted into the damaged part of the blood vessel along the guide wire, the guide wire is withdrawn, a diaphragm is folded and loaded on a loader and is conveyed to the damaged part of the blood vessel through the sheath tube, the sheath tube is withdrawn to release the limiting part of the positioning piece on the inner wall of the blood vessel, the sheath tube is continuously withdrawn to release the diaphragm on the outer wall of the blood vessel after the positioning piece to be placed at a proper position by the traction loader, the loader is withdrawn after the diaphragm is unfolded under the action of external environment or self characteristic action to be reset to an initial shape and is placed at a proper position, and the whole set of operation flow is completed. In conclusion, the membrane adopts the material capable of maintaining the shape of the membrane so as to meet the requirement of subsequent operation.

Preferably, the stopper portion is flexible and bendable, and is capable of generating a restoring force to restore the stopper portion when bent.

The positioning piece with certain flexibility is adopted, so that the problems of ulceration, inflammation and the like of a blood vessel contact part when the positioning piece is in contact friction with a blood vessel can be avoided.

Preferably, the limiting part is rod-shaped, narrow-band-shaped, sheet-shaped or net-shaped, and the positioning part is provided with through holes or anti-skid grains.

The limiting part is in a rod shape or a narrow band shape, so that the conveying sheath can be more smooth, the conveying sheath with smaller inner diameter can be used for conveying, the contact area between the limiting part and the surface of the blood vessel can be increased by adopting the limiting part in a sheet shape or a net shape, the irritation to the blood vessel is reduced, and the positioning performance of the diaphragm is improved. The through hole arranged on the positioning piece can reduce the mass of the positioning piece and simultaneously ensure that the volume of the positioning piece passing through the conveying sheath tube is smaller. The anti-slip lines arranged on the positioning piece can prevent the positioning piece from sliding relative to the surface of the blood vessel.

Preferably, the connecting part is rod-shaped, and the connecting part is fixedly connected with the diaphragm or connected with the diaphragm through a snare or a nut or a barb penetrating through a connecting hole on the diaphragm.

The connecting part is rod-shaped and is fixedly connected with the diaphragm. The length of the connecting part is set to be the wall thickness of the blood vessel so as to enable the limiting part and the diaphragm of the positioning piece to be tightly abutted to the inner side and the outer side of the tube wall of the blood vessel, and the defects that the diaphragm is easy to shift and blood flows out under the blood pressure are overcome.

Realize linking to each other of connecting portion and diaphragm through snare or nut or through the flexible barb that can one-way pass the connecting hole to make spacing portion and the diaphragm of setting element closely butt in the inside and outside both sides of pipe wall of blood vessel. The snare or nut or barb is equivalent to a simplified fixing device, and no fixing device is needed to be additionally arranged, so that the operation steps can be simplified, and the operation time can be reduced.

Preferably, the membrane and the positioning piece are made of degradable materials, and the degradable materials are any one of the following materials: polylactide, polyglycolide, polycaprolactone, polydioxanone, polyhydroxybutyrate, polyhydroxyalkanoate, polyanhydride, polyphosphoester, polyamino acid, cellulose, collagen, chitosan, polyurethane, and polycarbonate, or a derivative of any of the above-listed materials, or a copolymer of monomers of any at least two of the above-listed materials, or a blend of any at least two of the above-listed materials.

The diaphragm and the positioning piece are made of degradable materials, and the diaphragm and the positioning piece made of the degradable materials can be gradually degraded along with healing of blood vessels of a patient and are absorbed by a human body or discharged from the body without being taken out through a secondary operation, so that the life quality of the patient is improved, and the pain of the patient is reduced.

Preferably, the blood vessel patch further comprises a fixing device matched with the membrane patch, and the fixing device is used for attaching the membrane patch to the blood vessel.

The membrane is tightly attached to the outer wall of the blood vessel through the fixing device, blood cannot leak, and the closing effect is better.

Preferably, the fixing device is attached to the outer surface of the membrane and arranged around the blood vessel, the fixing device is at least partially overlapped with the membrane in the axial direction, and the axial direction is the extending direction of the blood vessel.

The fixing device is attached to the outer surface of the membrane so that the membrane is tightly attached to the outer surface of the blood vessel to completely block the damaged part of the blood vessel, and the membrane is fixed on the blood vessel through the fixing device annularly arranged on the blood vessel. The fixing device is at least partially overlapped with the diaphragm in the axial direction, so as to play an effective fixing role of the fixing device on the diaphragm. The axial direction is the extending direction of the blood vessel, and is the direction of arranging the related parts of the apparatus by taking the blood vessel as a reference object.

Preferably, the securing means at least partially overlaps the enclosed region.

By adopting the structure, when the diaphragm swells under the action of blood pressure, the fixing device can provide certain support for the diaphragm to avoid the swelling of the diaphragm, thereby further improving the attachment stability of the diaphragm.

Preferably, the fixing device is a strap, or the fixing device is a fixing ring.

Therefore, the membrane can be well fixed on the blood vessel, and the membrane is simple to manufacture and convenient to operate.

Preferably, the two ends of the binding band are connected through a fixing structure, the fixing structure is a binding band knot tying the two ends of the binding band together, or the fixing structure is a buckle fixing the two ends of the binding band together, or the fixing structure is a snare fixing the two ends of the binding band together, or the fixing structure is a first magnetic attraction piece fixing the two ends of the binding band together in an adsorbing manner.

The fixing structure is a binding band knot, a hasp, a snare or a first magnetic suction piece, and two ends of the fixing structure can be stably combined together, so that the membrane is stably attached to the surface of the blood vessel.

Preferably, the diaphragm is for can encircle the cyclic annular that the blood vessel was arranged, fixing device is for locating the piece is inhaled to the second magnetism of diaphragm both ends department, two the piece is inhaled to the second magnetism and is inhaled the mutual adsorption of overlap joint in order to realize magnetic adsorption, perhaps, two the piece is inhaled to the second magnetism's mutual actuation of side end face.

The structure is simple in design and convenient to operate, the arrangement and the conveying of a fixing device are omitted, and the membrane can be stably attached to the surface of a blood vessel. The blood vessel is fixed in a surrounding way by adopting a magnetic suction way, so that the operation can be effectively simplified, the operation time is shortened, and the harm to a patient is reduced.

The positive progress effects of the invention are as follows:

the product of the invention has simpler design and operation, the limiting part of the positioning piece is erected on the inner wall of the blood vessel at the edge of the damaged part of the blood vessel, and the connecting part of the positioning piece is used for penetrating through the damaged part of the blood vessel, so that the limiting part and the membrane can be respectively and tightly abutted against the inner side and the outer side of the wall of the blood vessel, the membrane is prevented from shifting, and the membrane is stably positioned at the damaged part of the blood vessel. Therefore, the blood can be prevented from flowing out of the damaged part of the blood vessel due to inaccurate positioning of the membrane, and a better closing effect can be obtained. For the blood vessel interventional operation, the operation of a doctor can be effectively simplified, and the operation time is shortened without sewing, so that the injury to a patient is reduced. Meanwhile, the limiting part arranged in the blood vessel can form certain separation to blood flow, and the diaphragm is prevented from bulging outwards under the action of blood pressure to cause blood to flow out. The diaphragm with the setting element adopts degradable material, along with the healing of patient's blood vessel, degradable material's diaphragm and setting element can degrade gradually, are absorbed or get rid of extracorporeally by the human body, do not have the residual foreign matter, and need not take out by the secondary operation to improve patient's quality of life, reduce patient's misery.

Drawings

FIG. 1 is a perspective view of embodiment 1;

FIG. 2 is a view showing the diaphragm and the positioning member in accordance with embodiment 1;

FIG. 3 is a side view showing the fitting relationship between the diaphragm and the positioning member in embodiment 1;

FIG. 4 is a perspective view of a stopper structure according to embodiment 1;

FIG. 5 is a perspective view showing a structure of a connecting portion in embodiment 1;

FIG. 6 is a perspective view showing another structure of a connecting portion in embodiment 1;

FIG. 7 is a perspective view of another stopper structure according to embodiment 1;

FIG. 8 is a perspective view of a fixing device according to embodiment 2;

fig. 9 is a partial enlarged view of a portion a in fig. 8;

FIG. 10 is a perspective view of a fixing device according to embodiment 3;

fig. 11 is a partial enlarged view of portion B of fig. 10;

description of the reference numerals:

diaphragm 100

Enclosed region 110

First end face 120

Second end face 130

Third end face 140

Connecting hole 150

Keeper 200

Position limiting part 210

Connecting part 220

Barb 221

Fastening device 300

Strap 310

Hasp 320

Second magnetic attraction piece 400

Blood vessel 500

Detailed Description

The invention is further illustrated by the following examples, which are not intended to limit the invention thereto.

Example 1

As shown in FIG. 1, a vascular closure device is provided at a lesion in the surface of a blood vessel 500 to prevent blood from flowing out of the blood vessel 500. The vascular closure device includes a membrane 100 having a closed region 110 corresponding to a vascular injury site on the membrane 100. The blood vessel damage site referred to herein is an incision, puncture, perforation, or the like created in the blood vessel 500 for invasive surgery such as minimally invasive surgery. The membrane 100 is used to be attached to the surface of the blood vessel 500, and the closed region 110 of the membrane 100 is correspondingly covered on the damaged portion to prevent the blood in the blood vessel 500 from flowing out. The closed area 110 is generally located at the center of the diaphragm 100 for good sealing. Of course, the membrane 10 is suitable for the actual needs of the operation0A plurality of closed areas 110 may be included, and the closed areas 110 may be located at other positions of the diaphragm 100 instead of being centered in the diaphragm 100. But the sealed area 110 is spaced from the edge of the membrane 100 to prevent blood in the vessel 500 from flowing directly out of the edge of the membrane 100.

As shown in fig. 2, 3, 4 and 5, the blood vessel closing device further includes a positioning member 200 disposed at the closed region 110, the positioning member 200 includes a position-limiting portion 210 spaced apart from the closed region 110 and a connecting portion 220 connecting the position-limiting portion 210 and the closed region 110, the connecting portion 220 is configured to penetrate through the damaged portion of the blood vessel so that the position-limiting portion 210 and the membrane 100 can be respectively abutted against the inner side and the outer side of the wall of the blood vessel 500.

With this structure, the position of the diaphragm can be limited by the static friction force and the clamping force applied to the inner and outer walls of the blood vessel by the limiting portion 210 and the diaphragm 100, and the connection portion 220 passing through the damaged portion of the blood vessel. Thus, the diaphragm 100 connected with the limiting part 210 and the connecting part 220 can be tightly abutted against the inner side and the outer side of the vessel wall of the blood vessel 500, so that the blood vessel closing device can be firmly limited on the blood vessel 500, and the defect that the damaged part of the blood vessel 500 cannot be effectively closed due to the displacement of the diaphragm 100 is overcome.

Meanwhile, the limiting part 210 arranged in the blood vessel 500 can form certain obstruction to the blood flowing outwards, and the defect that the diaphragm 100 bulges outwards under the action of the blood pressure to cause a gap to be formed between the diaphragm 100 and the outer tube wall of the blood vessel 500 to cause the blood to flow out is overcome. In addition, compared with the scheme of suturing the blood vessel 500 by an operation, the product also has the advantages of convenience in operation and simplicity in product design.

In this embodiment, the membrane 100 is coated with an expandable gel at a side surface facing the blood vessel 500, which expandable gel is capable of expanding upon absorption of a liquid to close the site of the blood vessel 500 injury.

By adopting the design, when a gap is formed between the diaphragm 100 and the wall of the blood vessel 500 so that blood flows out from the gap, the expandable gel can contact with the blood and absorb the blood so that the volume of the expandable gel expands to close the gap, and further close the damaged part of the blood vessel 500, and the blood can not flow out from the damaged part of the blood vessel 500.

Specifically, in the present embodiment, the expandable gel is coated on the entire surface of the side of the membrane 100 facing the blood vessel 500, and the expandable gel corresponding to the position of the slit of the membrane 100 can expand and close the slit no matter where the blood leaks out, thereby providing the best leakage prevention effect.

Preferably, the expandable gel is disposed in a ring shape on a side surface of the membrane 100 facing the blood vessel 500, and the damaged portion of the blood vessel 500 can be located in the ring formed by the expandable gel. With this configuration, blood leaking from the slit must contact the expandable gel, causing the expandable gel to expand in volume and close the gap between the membrane 100 and the blood vessel 500 after absorbing the blood. By adopting the structure, the material of the expandable gel can be effectively saved, and the cost is reduced.

The expandable gel is a material that expands upon contact with a liquid. The material which can expand when meeting liquid is a material which can expand in volume when meeting human body fluid or water, such as hydrogel material, and can be selected from one or more of polyvinyl alcohol, polyethylene glycol dimethacrylate, poly (ethylene glycol) diacrylate, hydroxyethyl methacrylate, polyoxyethylene-polyoxypropylene-polyoxyethylene, polyurethane, polyvinylpyrrolidone, vinylpyrrolidone-acrylic acid copolymer, polyacrylamide, polyvinyl caprolactam, polyacrylate, polyamino acid, carboxymethyl cellulose, polymethyl acrylate, alginate, polyhydroxyethyl methyl acrylate, acrylamide, polyacrylic acid, hydrolyzed polyacrylonitrile, polyethyleneimine, ethoxylated polyethyleneimine polyallylamine, hyaluronic acid, methacrylated hyaluronic acid, chitosan, collagen, gelatin, fibrin, dextran, and agarose.

The expandable gel is coated on the inner surface of the membrane 100 by one or more of spraying, brushing, die filling coating, dipping, roll coating, spin coating, molding, electrodeposition and vacuum vapor deposition, and is fixed on the inner surface of the membrane 100 by one or more of air oxidation curing, solvent volatilization curing, thermal or chemical reaction curing, radiation curing (including ultraviolet curing and electron beam curing), melt curing and infrared catalytic thermal reaction curing, preferably by a photocuring method with high bonding strength.

In this embodiment, the membrane 100 has a curvature that can fit the outer surface of the blood vessel 500, and such a structure can make the membrane 100 better fit the outer surface of the blood vessel 500, thereby preventing blood from leaking out of the gap between the membrane 100 and the blood vessel 500 due to the overlarge gap between the membrane 100 and the blood vessel 500.

In this embodiment, the diaphragm 100 is made of a material capable of maintaining the shape of the diaphragm 100. Specifically, the material used for the membrane 100 is a shape memory material or an elastic material. The shape memory material is a material that can be restored to an original shape at a body temperature or in a body fluid environment. The elastic material is a material with certain flexibility and can be restored to an original shape after being deformed under the action of external force.

As shown in fig. 2, 3, 4, 5, 6 and 7, in the present embodiment, the position-limiting portion 210 has a rod shape, a narrow band shape, a sheet shape or a net shape. Narrow strip as referred to herein means a rectangle having a large aspect ratio. The stopper portion 210 is flexible and bendable, and generates restoring force for restoring the stopper portion 210 when bent. In addition, the projection of the outward surface of the limiting part 210 facing the direction of the blood vessel wall at least partially overlaps with the blood vessel wall, i.e. at least part of the area of the limiting part 210 can be lapped on the inner tube wall at the edge of the damaged part of the blood vessel to realize the limiting effect.

The limiting part 210 is in a rod shape or a narrow band shape, so that the conveying sheath can be more smooth, the conveying sheath with smaller inner diameter can be used for conveying, the contact area between the limiting part 210 in a sheet shape or a net shape and the surface of the blood vessel can be increased by adopting the limiting part 210 in a sheet shape or a net shape, and the irritation to the blood vessel 500 is reduced, and meanwhile, the positioning performance of the diaphragm 100 is improved.

In order to allow the pharmaceutical composition carried on the membrane 100 to smoothly enter the blood. The positioning piece is also preferably provided with a through hole structure to improve the permeability of the medicine components. The through holes are preferably arranged perpendicular to the membrane 100 to obtain a shorter pitch, although the invention is not limited to having the through holes perpendicular to the membrane 100, as it is equally feasible to have an angle between the direction of extension of the through holes and the direction of extension of the membrane 100.

In this embodiment, in order to reduce the stimulation of the blood vessel 500 caused by the sliding between the positioning member and the surface of the blood vessel 500, the positioning member is further provided with anti-slip lines, so that the friction between the blood vessel 500 and the positioning member is increased, the relative sliding between the positioning member and the surface of the blood vessel 500 is reduced, and the stimulation of the blood vessel 500 is reduced. This anti-skidding line can only set up the edge at the both ends of bar-like or narrow banding setting element and netted or slice setting element, also can all set up this anti-skidding line on whole setting element.

In this embodiment, the connecting portion 220 is rod-shaped, and the connecting portion 220 is fixedly connected to the membrane 100, or can be connected to the membrane 100 through a snare or a nut or a barb 221 penetrating through the connecting hole 150 of the membrane 100, so that the stopper 210 and the membrane 100 are tightly abutted against the inner and outer walls of the blood vessel, and the membrane 100 is stably fixed and tightly attached to the outer surface of the blood vessel.

Specifically, connecting portion 220 and diaphragm 100 fixed connection, the length of connecting portion 220 generally sets up to the wall thickness of blood vessel, and the diaphragm 100 that enables spacing portion 210 and connecting portion 220 to link to each other like this closely butts in the inside and outside both sides of blood vessel 500 pipe wall, and then makes the blood vessel closing device can be firm spacing on blood vessel 500, has solved because of diaphragm 100 appears shifting easily and has leaded to effectively closing the defect that blood vessel 500 damaged position and blood flowed out under blood pressure easily.

Specifically, in the scheme that the connecting portion 220 is connected with the membrane 100 through the snare, when the limiting portion 210 of the positioning member is placed at a proper position on the inner wall of the blood vessel 500, the membrane 100 is unfolded to an initial shape, the membrane 100 is gradually attached to the outer wall of the blood vessel 500 by pushing the membrane 100 and pulling the connecting portion 220, the connecting portion 220 protruding out of the membrane 100 is tied through the snare, and the membrane 100 is fixed and tightly attached to the outer surface of the blood vessel 500.

Specifically, in the scheme of using the screw connection between the membrane 100 and the connection portion 220, the outer surface of the connection portion 220 is provided with a screw thread, and then the membrane 100 is locked and attached to the outer wall of the blood vessel 500 by a nut. The design structure is simple, the use is more convenient, and the operation is more simple and convenient.

Specifically, the connection part 220 is connected to the diaphragm 100 through the barb 221 penetrating through the connection hole 150 of the diaphragm 100, as follows: the connecting portion 220 is provided with a plurality of sets of umbrella-shaped barbs 221 along the axial direction, the barbs 221 are formed by a plurality of flexible barbs extending obliquely towards the direction of the limiting portion 210, and the flexible barbs are uniformly arranged at intervals along the radial direction of the connecting portion 220 and are umbrella-shaped. The diaphragm 100 is correspondingly provided with a connecting hole 150, and the barb 221 can be flexibly deformed to pass through the connecting hole 150 when being inserted into the connecting hole 150, and can be restored after passing through the connecting hole 150 to prevent the barb 221 from being pulled out of the connecting hole 150. The plurality of umbrella-shaped barbs 221 are arranged along the axial direction, so that the diaphragm can stay at the corresponding axial position to control the distance between the limiting part 210 and the diaphragm 100, and the diaphragm 100 and the limiting part 210 can correspondingly abut against two sides of the tube wall of the blood vessel 500. When the blood vessel 500 is used, when the limiting part 210 of the positioning piece is placed at a proper position on the inner wall of the blood vessel 500, the membrane 100 is unfolded to be in an initial shape, the membrane 100 is gradually attached to the outer wall of the blood vessel 500 by pushing the membrane 100 and pulling the connecting part 220, and the membrane 100 is fixed and tightly attached to the outer surface of the blood vessel 500 through the barbs 221 on the connecting part 220. The design structure is simple, the use is more convenient, and the operation is more simple and convenient.

In the embodiment, the positioning member 200 is made of a homogeneous material with a certain flexibility, so that the positioning member 200 is not easy to damage the blood vessel 500 when contacting and rubbing the surface of the blood vessel 500, and the problems of ulceration, inflammation and the like at the contact part of the blood vessel 500 are avoided. In addition, the positioning member 200 can be bent along with the shape of the sheath when passing through the sheath, so that the positioning member can more easily pass through the sheath. Moreover, the membrane 100 can be positioned effectively and the displacement of the membrane 100 can be avoided because the membrane can spontaneously recover the original shape after being bent.

Of course, the above is only one embodiment adopted by the present invention, and the positioning member can also be composed of a flexible skin layer and a rigid core, where the rigid core is referred to as the core material having a rigidity greater than that of the skin material, but the core material still has flexibility to be able to bend under an external force and to recover after the external force is released.

The above are specific structures of the positioning element 200 and the membrane 100, when in use, a guide wire is inserted into a blood vessel to make a passage communicated with the damaged part of the blood vessel 500, then the sheath of the sheath is inserted into the damaged part of the blood vessel 500 along the guide wire, the guide wire is withdrawn, the membrane 100 is folded and loaded on a loader and conveyed to the damaged part of the blood vessel 500 through the sheath, the sheath is withdrawn to release the limiting part of the positioning element on the inner wall of the blood vessel 500, after the positioning element is placed at a proper position by drawing the loader, the sheath is continuously withdrawn to release the membrane 100 on the outer wall of the blood vessel 500, after the membrane 100 is stretched and reset to an initial shape at body temperature or in a body fluid environment and is placed at a proper position by drawing the loader, the loader is withdrawn, and the whole set of operation process is completed, so that the installation of the blood vessel closing device is realized. It can be seen that the diaphragm 100 is made of a material capable of maintaining the shape of the diaphragm 100 to meet the subsequent operation requirements.

In this embodiment, both the membrane 100 and the positioning member 200 are made of degradable material, and the degradable material is any one of the following materials: polylactide, polyglycolide, polycaprolactone, polydioxanone, polyhydroxybutyrate, polyhydroxyalkanoate, polyanhydride, polyphosphoester, polyamino acid, cellulose, collagen, chitosan, polyurethane, and polycarbonate, or a derivative of any of the above-listed materials, or a copolymer of monomers of any at least two of the above-listed materials, or a blend of any at least two of the above-listed materials.

The following is that a specific raw material component of the membrane 100 is polydioxanone;

in the following, one specific raw material component of the positioning member 200 in the examples is polydioxanone.

In this embodiment, the vascular closure device further comprises a fixation device 300 cooperating with the membrane 100, the fixation device 300 being adapted to attach the membrane 100 to the blood vessel 500. Specifically, the fixing device 300 is attached to the outer surface of the membrane 100 and disposed around the blood vessel 500, and the fixing device 300 and the membrane 100 at least partially overlap in the axial direction, which is the extending direction of the blood vessel 500. Thus, the fixation device 300 is capable of applying pressure to the membrane 100 towards the outer surface of the blood vessel 500 to fix the membrane 100 at a given position on the blood vessel 500. Preferably, the fixation device 300 is made of a degradable material.

More preferably, the fixation device 300 preferably partially overlaps the sealing region 110 of the membrane 100 corresponding to the rupture of the blood vessel 500. Thus, when the diaphragm 100 is subjected to the positive blood pressure, the fixing device 300 can provide a force for preventing the diaphragm 100 from bulging to the diaphragm 100, so that the diaphragm 100 does not bulge under the blood pressure, and the attachment stability between the diaphragm 100 and the blood vessel 500 is further improved.

Specifically, the overlapping portion of the fixing device 300 and the closed area 110 on the membrane 100 is preferably located right in the middle of the closed area 110, so as to avoid local bulging of the membrane 100 due to uneven force.

Referring to fig. 1, in this embodiment, the fixing device 300 is in the form of a ring, which may be a band 310, and when in use, a channel is established around the blood vessel 500 by the guide wire and the sheath, then the guide wire is removed, the band 310 is loaded on the loader through the sheath around the blood vessel 500, and then the loader and the sheath are removed, and the two ends of the band 310 are fixed by the fixing structure, so as to bind the membrane 100.

The strap 310 is preferably wide in the middle and narrow at both ends (not shown). The wider middle part is adopted, so that the membrane 100 can be better pressed, the pressure on the blood vessel 500 can be reduced, and the stimulation on the wall of the blood vessel 500 is reduced; the use of thinner end portions facilitates the tying of the knot by the operator and facilitates the passage of the band 310 through the sheath. Of course, straps 310 having a uniform width may also be used for smaller membrane 100 sizes.

In this embodiment, the fixing structure may also be a buckle 320 for connecting the two ends of the strap 310 together, and the connection and fixation of the two ends of the strap 310 are realized by inserting the strap 310 into the buckle 320. This arrangement helps to reduce the technical requirements on the operator while the connection is more reliable.

Alternatively, the fixing structure for fixing the two ends of the band 310 may be a knot (not shown) for tying the two ends of the band 310, and the knot may be a square knot, a triple knot or a surgical knot, and the operator may tie the knot of the band 310 by an instrument operation (e.g., snare) or directly by hand after transporting the band 310 to a designated position. This construction has the advantage of being simple, but requires a high level of skill on the part of the operator.

As another alternative, the fixing structure may also be a first magnetic member (not shown) that fixes the two ends of the binding band 310 together in an attracting manner, and the first magnetic member is made of degradable magnetic polymer material and is disposed at the two ends of the binding band 310. During the operation, the operator only needs to be close to bandage 310 both ends and can realize magnetic adsorption, and the operation is more simple convenient.

As a further alternative, the fixation device 300 may be a fixation ring (not shown), wherein the fixation ring according to the present invention may be formed by two half rings hinged together, and wherein the two half rings are operatively connected to the non-hinged ends of the two half rings, thereby achieving circumferential fixation of the fixation device 300 to the membrane 100 on the blood vessel 500. In addition, the fixing ring may be a hoop with a notch, and during operation, the hoop is hooped on the blood vessel 500 by using the deformation of the ring itself, so as to realize the surrounding and fixing of the membrane 100 on the blood vessel 500.

Example 2

As shown in fig. 8 and 9, the vascular closure device in this embodiment differs from the vascular closure device in embodiment 1 in that: in embodiment 2, the membrane 100 is in a ring shape capable of being disposed around the blood vessel 500, the fixing device 300 is a second magnetic member 400 disposed at two ends of the membrane 100, and the two ends of the membrane 100 are attracted by the second magnetic member 400 so that the membrane 100 can be attached to the surface of the blood vessel 500.

Specifically, both ends of the diaphragm 100 have a first end surface 120 as an outer surface, a second end surface 130 as an inner surface, and a third end surface 140 as a side surface. Here, the outer surface is the surface of the second magnetic element 400 facing away from the blood vessel 500, the inner surface is the surface of the second magnetic element 400 facing toward the blood vessel 500, and the side surface is the side surface of the second magnetic element 400 at one end.

In this embodiment, the second magnetic element 400 is disposed on the first end surface 120 of one end of the diaphragm 100 and the second end surface 130 of the other end of the diaphragm 100. So that the inner surface of one end of the diaphragm 100 and the outer surface of the other end of the diaphragm 100 are attracted to each other to fix the diaphragm 100.

The second magnetic element 400 is made of degradable magnetic polymer material, and can exist in the form of a coating layer coated on the first end surface 120, the second end surface 130, or the third end surface 140 of the diaphragm 100, or exist in the form of particles infiltrated into the first end surface 120, the second end surface 130, or the third end surface 140 of the diaphragm 100.

The structure of the embodiment can not only help to simplify the structure of the vascular closing device, but also reduce the technical requirements on operators, and the design is more convenient to use.

Example 3

As shown in fig. 10 and 11, the blood vessel closing device in the present embodiment is different from that in embodiment 2 in that:

in this embodiment, the second magnetic member 400 is disposed on the third end surface 140 (i.e. the side surface) of the two ends of the membrane 100, so that the side surfaces of the two ends of the membrane 100 can be mutually attracted to form a ring shape arranged around the blood vessel 500.

The structure of the embodiment can also help to simplify the structure of the vascular closing device, and can also reduce the technical requirements on operators, and the design is more convenient to use.

While specific embodiments of the invention have been described above, it will be appreciated by those skilled in the art that this is by way of example only, and that the scope of the invention is defined by the appended claims. Various changes and modifications to these embodiments may be made by those skilled in the art without departing from the spirit and scope of the invention, and these changes and modifications are within the scope of the invention.

Claims

1. A vascular closure device comprising a membrane having an enclosed area thereon corresponding to a site of vascular disruption, wherein: the blood vessel closing device further comprises a positioning piece arranged at the closed area, the positioning piece comprises a limiting part arranged at an interval with the closed area and a connecting part connected with the limiting part and the closed area, and the connecting part is used for penetrating through the damaged part of the blood vessel so that the limiting part and the diaphragm can be respectively abutted against the inner side and the outer side of the wall of the blood vessel;

the membrane is coated with an expandable gel at the surface of the side facing the blood vessel, the expandable gel being capable of expanding upon absorption of a liquid to occlude the vascular lesion;

the vascular closure device further comprises a fixing device matched with the membrane, and the fixing device is used for attaching the membrane to a blood vessel.

2. The vasculature closure device of claim 1, wherein: the expandable gel is coated on the whole surface of one side, facing the blood vessel, of the membrane, or the expandable gel is annularly arranged on the surface of one side, facing the blood vessel, of the membrane, and the damaged part of the blood vessel can be correspondingly positioned in the ring formed by the expandable gel.

3. The vasculature closure device of claim 1, wherein: the diaphragm has the radian that can the adaptation blood vessel surface, the diaphragm adopts and to maintain the material of diaphragm shape is made, and/or, spacing portion has the pliability and can be crooked to can produce when crooked and make the restoring force that spacing portion recovers, and/or, spacing portion is bar-shaped or narrow band form or slice or netted, be equipped with through-hole or anti-skidding line on the setting element, and/or, connecting portion are the bar-shaped, connecting portion with diaphragm fixed connection or through snare or nut or pass the barb of connecting hole links to each other on the diaphragm.

4. The vascular closure device according to any of claims 1 to 3, wherein: the diaphragm and the positioning piece are made of degradable materials, and the degradable materials are any one of the following materials: polylactide, polyglycolide, polycaprolactone, polydioxanone, polyhydroxybutyrate, polyhydroxyalkanoate, polyanhydride, polyphosphoester, polyamino acid, cellulose, collagen, chitosan, polyurethane, and polycarbonate, or a derivative of any of the above-listed materials, or a copolymer of monomers of any at least two of the above-listed materials, or a blend of any at least two of the above-listed materials.

5. The vasculature closure device of claim 1, wherein: the fixing device is attached to the outer surface of the membrane and arranged around the blood vessel, at least part of the fixing device is overlapped with the membrane in the axial direction, the axial direction is the extending direction of the blood vessel, and/or at least part of the fixing device is overlapped with the closed area.

6. The vasculature closure device of claim 5, wherein: the fixing device is a binding band, or the fixing device is a fixing ring.

7. The vasculature closure device of claim 6, wherein: the two ends of the binding band are connected through a fixing structure, the fixing structure is a binding band knot tying the two ends of the binding band together, or the fixing structure is a buckle fixing the two ends of the binding band together, or the fixing structure is a snare fixing the two ends of the binding band together, or the fixing structure is a first magnetic attraction piece fixing the two ends of the binding band together in an adsorbing mode.

8. The vasculature closure device of claim 1, wherein: the piece is inhaled to the second magnetism of diaphragm both ends department, two the piece is inhaled to the second magnetism is inhaled the mutual overlap joint in order to realize magnetic adsorption, perhaps, two the side end face mutual actuation of piece is inhaled to the second magnetism.