CN115517725B

CN115517725B - Vascular wound sealing device and method

Info

Publication number: CN115517725B
Application number: CN202211486809.0A
Authority: CN
Inventors: 刘文菁; 刘振兴; 许自远
Original assignee: Suzhou Meichuang Medical Technology Co ltd
Current assignee: Suzhou Meichuang Medical Technology Co ltd
Priority date: 2022-11-25
Filing date: 2022-11-25
Publication date: 2023-03-21
Anticipated expiration: 2042-11-25
Also published as: CN115517725A

Abstract

The embodiment of the invention provides a blood vessel wound sealing device and a method, and relates to the field of medical instruments. Aims to improve the sealing effect of the vascular wound and the problem of poor efficiency. The blood vessel wound sealing device comprises a sealing sponge, a sealing patch, a suture and a pre-tightening assembly; the sealing sponge is used for sealing the vascular wound from the outer side of the blood vessel; the sealing patch is used for sealing the vascular wound from the inner side of the blood vessel; the suture is connected with the pre-tightening component and is used for being fixed through the pre-tightening component in a suture tensioning state, so that the tight sealing patch and the sealing sponge are pulled to clamp and seal the vascular wound from the inner side and the outer side of the blood vessel respectively. The blood vessel wound sealing method is implemented by adopting the device. The inner wall of the blood vessel is attached through the sealing patch, the outer wall of the blood vessel is sealed by the sealing sponge, the suture is fixed through the pre-tightening assembly, the sealing sponge and the sealing patch are connected to form the inner side and the outer side of the wound of the whole blood vessel, the hemostatic effect is achieved, and the operation is simple, convenient and time-saving.

Description

Vascular wound sealing device and method

Technical Field

The invention relates to the field of medical equipment, in particular to a blood vessel wound sealing device and a method.

Background

With the development of the cardiovascular intracavity technology, interventional operations such as endovascular aneurysm repair (EVAR), transcatheter aortic valve replacement (TAVI), mechanical Circulatory Support (MCS), etc. gradually replace surgical operations, and become better clinical options. However, these procedures often require a large caliber vascular access, which in turn is highly associated with vascular and bleeding complications. Corresponding vascular and bleeding complications are still common despite the reduction in diameter of clinically invasive devices, with TAVI as high as 20% and EVAR as high as 12-22% reported. These adverse events result in prolonged hospital stays and increased short and long term mortality. The conventional methods of pressing, suturing, and bonding are time consuming, and tend to cause unnecessary deformation of the blood vessel, and it is difficult to achieve a good sealing effect.

Disclosure of Invention

Objects of the invention include, for example, providing a vascular wound sealing device that improves the sealing of vascular wounds and the problem of inefficiency.

The invention also aims to provide a blood vessel wound sealing method which can improve the sealing effect of the blood vessel wound and the problem of poor efficiency.

Embodiments of the invention may be implemented as follows:

the embodiment of the invention provides a blood vessel wound sealing device which is used for sealing a blood vessel wound on a blood vessel, and comprises a sealing sponge, a sealing patch, a suture and a pre-tightening assembly; the sealing patch, the sealing sponge and the pre-tightening assembly are arranged in sequence; the suture is movably arranged on the sealing sponge and the sealing patch in a penetrating way, and the suture is connected with the pre-tightening assembly; the sealing patch is used for being attached to the inner wall of the blood vessel so as to seal the blood vessel wound from the inner side of the blood vessel; the sealing sponge is used for being attached to the outer wall of the blood vessel after being expanded so as to seal the blood vessel wound from the outer side of the blood vessel; the suture is used for being fixed through the pre-tightening assembly after being tightened, and the sealing patch and the sealing sponge are tightened to clamp and seal the vascular wound from the inner side and the outer side of the blood vessel respectively.

In addition, the vascular wound sealing device provided by the embodiment of the invention can also have the following additional technical characteristics:

optionally, the two ends of the suture are a first thread end and a second thread end; the pre-tightening assembly comprises an elastic fixing knot and a fixing gasket; the elastic fixing knot is fixed on the suture, and the elastic fixing knot is positioned between the second thread end of the suture and the sealing sponge; the fixing gasket is provided with a pre-tightening hole, and the second end of the suture movably penetrates through the pre-tightening hole; the first end of the suture is used for being fixed relative to the fixing gasket under the condition that the second end of the suture is tensioned;

the elastic fixing knot is used for being positioned between the sealing sponge and the fixing gasket under the state that the second line end of the suture is not tensioned, or the elastic fixing knot is used for being extruded to penetrate through the pre-tensioning hole under the state that the second line end of the suture is tensioned so as to press and fix the fixing gasket from one side of the fixing gasket, which is far away from the sealing sponge, and thus the sealing patch and the collagen sponge are tensioned.

Optionally, the first end of the suture forms a clamping ring; the clamping ring is movably sleeved between the second wire end of the suture and the fixed gasket by bypassing the fixed gasket.

Optionally, the first end of the suture forms a clamping ring; the fixing gasket is provided with a through hole, and the clamping ring movably penetrates through the through hole and then is movably sleeved between the second line end of the suture and the fixing gasket.

Optionally, the first end of the suture is secured to the fixation pad.

Optionally, the pre-tightening hole has a first hole end and a second hole end, which are opposite to each other in position, the first hole end is far away from the sealing sponge relative to the second hole end, the aperture of the first hole end is smaller than that of the second hole end, and the aperture of the first hole end is smaller than that of the elastic fixing knot.

Optionally, the sealing sponge is provided with a first suture hole; the sealing patch is provided with second suture holes and third suture holes at intervals; the second end of the suture movably penetrates through the first suture hole, and the suture movably penetrates through the second suture hole and the third suture hole.

Optionally, the sealing sponge has a first sponge end and a second sponge end which are opposite in position; the second sponge end is used for being attached to the outer wall of the blood vessel, and the cross-sectional area of the first sponge end is larger than that of the second sponge end.

Optionally, the sealing sponge comprises a plurality of folding parts connected in sequence, and the folding parts are stacked in sequence along the direction from the second sponge end to the first sponge end.

Optionally, the sealing sponge comprises a plurality of disk parts with gradually increasing diameters, and the disk parts are sequentially stacked along the direction from the second sponge end to the first sponge end.

Optionally, the sealing patch is provided with a blood flow channel for blood flow within the blood vessel.

Optionally, the sealing patch has relative upper surface and lower surface in position, the upper surface be used for with the laminating of the inner wall of blood vessel, the lower surface is provided with the rib portion.

Optionally, the vascular wound sealing device further comprises an absorbable reinforcing wire mesh; the reinforcing wire mesh is disposed within the sealing patch.

Optionally, the sealing patch includes a first sealing portion, an intermediate portion and a second sealing portion connected in sequence, the first sealing portion and the second sealing portion are symmetrically disposed with respect to the intermediate portion, and an edge of the intermediate portion protrudes with respect to edges of the first sealing portion and the second sealing portion.

Optionally, the fixed gasket is provided with a first guide wire channel, the sealing sponge is provided with a second guide wire channel, the sealing patch is provided with a third guide wire channel, the first guide wire channel, the second guide wire channel and the third guide wire channel are communicated in sequence, and the first guide wire channel, the second guide wire channel and the third guide wire channel are jointly used for a guide wire to pass through.

The embodiment of the invention also provides a blood vessel wound sealing method. The method is implemented by adopting a blood vessel wound sealing device, and comprises the following steps:

operating the sealing sponge to be positioned on the outer wall of the blood vessel of the sample;

operating the sealing patch on the inner wall of the blood vessel of the sample;

operating the suture tensioning and operating the pre-tightening assembly to fix the suture, thereby tensioning the sealing patch and the sealing sponge to clamp and seal the vascular wound from the inside and the outside of the blood vessel, respectively.

The blood vessel wound sealing device and the method of the embodiment of the invention have the beneficial effects of, for example:

the blood vessel wound sealing device comprises a sealing sponge, a sealing patch, a suture and a pre-tightening assembly; the sealing patch, the sealing sponge and the pre-tightening assembly are sequentially arranged; the suture is movably arranged on the sealing sponge and the sealing patch in a penetrating way, and the suture is connected with the pre-tightening assembly; the sealing patch is used for being attached to the inner wall of the blood vessel so as to seal the blood vessel wound from the inner side of the blood vessel; the sealing sponge is used for being attached to the outer wall of the blood vessel after being expanded so as to seal the wound of the blood vessel from the outer side of the blood vessel; the suture is used for being fixed through the pre-tightening assembly after being tightened, and the tightening sealing patch and the sealing sponge clamp and seal the vascular wound from the inner side and the outer side of the blood vessel respectively.

When the sealing patch is used for sealing, the sealing patch is tightly attached to the upper wall of a blood vessel, so that the blood flow can be sealed; the sealing sponge expands when meeting blood to seal the upper wall of the blood vessel; make pretension subassembly chucking through the suture tensioning, realize the fixed of suture for sealed sponge presss from both sides tight vascular wall with the sealed paster from the inside and outside, realizes the sealed to the vascular wound. The sealing sponge does not expand and block the vascular wound, and the healing of the vascular wound is not influenced. The sealing effect is good, and the operation is more efficient. Solves the difficult problem of closing the large-caliber blood vessel puncture, and can achieve the clinical effects of safe and effective hemostasis, high stability and degradability.

The blood vessel wound sealing method is implemented by adopting the device, so that the problems of poor blood vessel wound sealing effect and poor efficiency are solved.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings required in the embodiments will be briefly described below, it should be understood that the following drawings only illustrate some embodiments of the present invention and therefore should not be considered as limiting the scope, and those skilled in the art can also obtain other related drawings based on the drawings without inventive efforts.

FIG. 1 is a schematic view of a sealing device for sealing a vascular wound according to an embodiment of the present invention;

FIG. 2 is an enlarged view of a portion of FIG. 1;

FIG. 3 is a schematic view of the overall structure of a vascular wound sealing device according to an embodiment of the present invention;

FIG. 4 is a schematic view of a suture and elastic securing knot in a vascular wound sealing device according to an embodiment of the present invention;

fig. 5 is a schematic structural view of a first fixing pad in a vascular wound sealing device according to an embodiment of the present invention;

FIG. 6 is a top plan view of the first type of mounting pad shown in FIG. 5;

FIG. 7 isbase:Sub>A cross-sectional view A-A of FIG. 6;

FIG. 8 is a schematic diagram of a second type of mounting pad in a vascular wound sealing device, according to an embodiment of the present invention;

FIG. 9 is a top view of the second type of securement pad shown in FIG. 8;

FIG. 10 is a cross-sectional view taken along line B-B of FIG. 9;

FIG. 11 is a schematic structural view of a first sealing sponge in the vascular wound sealing device according to the present invention;

FIG. 12 is a schematic structural view of a second sealing sponge in the vascular wound sealing device according to the embodiment of the present invention;

FIG. 13 is a schematic structural view of a third sealing sponge in the vascular wound sealing device according to the present invention;

FIG. 14 is a schematic structural view of a fourth sealing sponge in the blood vessel wound sealing device according to the embodiment of the present invention;

FIG. 15 is a schematic diagram of a first sealing patch in a vascular wound sealing device, according to an embodiment of the present invention;

fig. 16 is a schematic structural view of a second sealing patch in a vascular wound sealing device according to an embodiment of the present invention;

FIG. 17 is a schematic illustration of the internal structure of a second sealing patch in a vascular wound sealing device, in accordance with an embodiment of the present invention;

fig. 18 is a top view of a third sealing patch in a vascular wound sealing device according to an embodiment of the present invention;

fig. 19 is a top view of a fourth sealing patch in a vascular wound sealing device, according to an embodiment of the present invention;

FIG. 20 is a top view of a fifth sealing patch in a vascular wound sealing device according to an embodiment of the present invention;

fig. 21 is a top view of a sixth sealing patch in a vascular wound sealing device, according to an embodiment of the present invention;

FIG. 22 is a schematic view of a first configuration of a vascular wound sealing device according to an embodiment of the present invention;

FIG. 23 is a schematic structural view of a second configuration of a vascular wound sealing device according to an embodiment of the present invention;

FIG. 24 is a schematic structural view of a third configuration of a vascular wound sealing device in accordance with an embodiment of the present invention;

fig. 25 is a structural diagram of a fourth structure of the vascular wound sealing device provided by the embodiment of the invention.

Icon: 10-a vascular wound sealing device; 20-blood vessels; 21-upper wall of blood vessel; 22-lower vessel wall; 23-vascular wound; 30-tissue; 100-a pre-tensioning assembly; 110-a fixed shim; 111-pre-tensioning holes; 112-a reinforcing rib net; 113-punching; 120-elastic fixation knot; 200-sealing sponge; 210 — a first suture hole; 220-a fold; 230-a disc portion; 300-sealing the patch; 310-a second suture hole; 311-a third suture hole; 320-a blood flow channel; 330-reinforcing rib parts; 350-a third guidewire channel; 360-sealing the outer ring; 361-a first seal; 362-an intermediate portion; 363-a second seal; 400-suture; 410-a first wire end; 411-a clamping ring; 420-second line end.

Detailed Description

In order to make the objects, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are some, but not all, embodiments of the present invention. The components of embodiments of the present invention generally described and illustrated in the figures herein may be arranged and designed in a wide variety of different configurations.

Thus, the following detailed description of the embodiments of the present invention, presented in the figures, is not intended to limit the scope of the invention, as claimed, but is merely representative of selected embodiments of the invention. All other embodiments, which can be obtained by a person skilled in the art without inventive step based on the embodiments of the present invention, are within the scope of protection of the present invention.

It should be noted that: like reference numbers and letters refer to like items in the following figures, and thus, once an item is defined in one figure, it need not be further defined and explained in subsequent figures.

In the description of the present invention, it should be noted that if the terms "upper", "lower", "inside", "outside", etc. indicate an orientation or a positional relationship based on that shown in the drawings or that the product of the present invention is used as it is, this is only for convenience of description and simplification of the description, and it does not indicate or imply that the device or the element referred to must have a specific orientation, be constructed in a specific orientation, and be operated, and thus should not be construed as limiting the present invention.

Furthermore, the appearances of the terms "first," "second," and the like, if any, are used solely to distinguish one from another and are not to be construed as indicating or implying relative importance.

It should be noted that the features of the embodiments of the present invention may be combined with each other without conflict.

The vascular wound sealing device 10 provided in the present embodiment is described in detail below with reference to fig. 1 to 25.

Referring to fig. 1, 2 and 3, an embodiment of the present invention provides a blood vessel wound sealing device 10 for sealing a blood vessel wound 23 on a blood vessel 20, the blood vessel wound sealing device 10 including a sealing sponge 200, a sealing patch 300, a suture 400 and a pre-tightening assembly 100; the sealing patch 300, the sealing sponge 200 and the pre-tightening assembly 100 are arranged in sequence; the suture 400 is movably arranged on the sealing sponge 200 and the sealing patch in a penetrating way, and the suture 400 is connected with the pre-tightening assembly 100; the sealing patch 300 is used to adhere to the inner wall of the blood vessel 20 to seal the blood vessel wound 23 from the inside of the blood vessel 20; the sealing sponge 200 is used for being attached to the outer wall of the blood vessel 20 after being expanded so as to seal the blood vessel wound 23 from the outer side of the blood vessel 20; the suture 400 is used to be fixed by the pre-tightening assembly 100 after being tightened, and the tightening sealing patch 300 and the sealing sponge 200 clamp and seal the vascular wound 23 from the inside and the outside of the blood vessel 20, respectively.

It should be noted that: the sealing sponge 200, the sealing patch 300, the suture 400 and the pre-tightening assembly 100 are all made of absorbable materials which have good biocompatibility and are harmless to human bodies, and the absorbable materials can be gradually absorbed by the human bodies after the sealing of the vascular wound 23 is completed. The sealing sponge 200 may be a collagen sponge, or a gelatin sponge. For example, the sealing sponge 200, the sealing patch 300, the suture 400, and the pre-tightening assembly 100 may be made of polyglycolic acid (PGA), polydioxanone (PDO), polylactic-co-glycolic acid (PLGA), or the like. In other embodiments, non-absorbable materials may be used for the sealing sponge 200, sealing patch 300, suture 400, and pre-tensioning assembly 100.

Referring to fig. 1 and 2, the blood vessel 20 includes an upper blood vessel wall 21 and a lower blood vessel wall 22, blood flows between the upper blood vessel wall 21 and the lower blood vessel wall 22, and both the outer sides of the upper blood vessel wall 21 and the lower blood vessel wall 22 are tissues 30. The blood vessel wound sealing device 10 is conveyed to the position of a blood vessel wound 23 through a surgical instrument, the sealing patch 300 is positioned on the inner side of the upper wall 21 of the blood vessel, the sealing sponge 200 is positioned on the outer side of the upper wall 21 of the blood vessel, and the upper surface of the sealing patch 300 can be attached to the upper wall 21 of the blood vessel to realize hemostasis sealing; the sealing sponge 200 is expanded by blood suction to block and stop bleeding on the upper wall 21 of the blood vessel; the pre-tightening assembly 100 is tightly clamped through tightening the suture 400, the suture 400 is fixed, and the sealing patch 300 and the sealing sponge 200 are clamped and fixed, so that the sealing sponge 200 and the sealing patch 300 clamp the wall of the blood vessel 20, and the blood vessel wound 23 is sealed.

The suture 400 is "movably threaded", and the suture 400 can be freely drawn relative to the sealing sponge 200 and the sealing patch 300, so that the sealing sponge 200 and the sealing patch 300 can be conveniently tensioned together by tensioning the suture 400. "both ends of the suture 400 are located at a side of the sealing sponge 200 facing away from the sealing patch 300", referring to fig. 2, both ends of the suture 400 are located at an upper side of the sealing sponge 200. "the suture 400 is connected with the pre-tightening assembly 100 — the suture 400 is used for being fixed by the pre-tightening assembly 100 after being tightened, and the tightening sealing patch 300 and the sealing sponge 200 are used for clamping and sealing the blood vessel wound 23 from the inner side and the outer side of the blood vessel 20 respectively", the suture 400 can tighten the sealing sponge 200 and the sealing patch 300 together in a tightening state, when the suture 400 is tightened, the pre-tightening assembly 100 can fix the suture 400, so that the sealing sponge 200 and the sealing patch 300 clamp and fix the blood vessel wound 23 from the inner side and the outer side of the wall of the blood vessel 20, and after the suture 400 is fixed, the sealing sponge 200 is fixed with the sealing patch 300, so that the blood vessel wound 23 can be stably and firmly sealed. Specifically, the suture 400 is connected to the pre-tightening assembly 100, and one end of the suture 400 is used to be fixed relative to the suture 400 by the pre-tightening assembly 100 in a state that the other end of the suture 400 is tightened, so that the tight sealing patch 300 and the sealing sponge 200 are pulled to clamp and seal the blood vessel wound 23 from the inner side and the outer side of the blood vessel 20, respectively.

The pre-tightening assembly 100 realizes pre-tightening of the suture 400, and the pre-tightened suture 400 can enable the sealing patch 300 and the sealing sponge 200 to be connected into a whole, so that the stability of the sealing sponge 200 and the sealing patch 300 is guaranteed. The sealing sponge 200 performs non-expansion plugging on the blood vessel wound 23, and does not influence the healing of the blood vessel wound 23.

The suture 400 cutting position may be determined according to the surgical situation. The suture 400 is located within the skin surface and the suture 400 is sealed for absorption. Suture 400 is positioned on the outside of the skin surface to enhance the fixation of vascular wound sealing device 10 by securing suture 400 to the skin, and suture 400 may be selectively secured to the skin depending on whether the procedure is desired.

Referring to fig. 2, 3 and 4, in the present embodiment, two ends of the suture 400 are a first thread end 410 and a second thread end 420; the pretensioning assembly 100 comprises an elastic fixing knot 120 and a fixing gasket 110; the elastic securing knot 120 is secured to the suture 400 with the elastic securing knot 120 positioned between the second end 420 of the suture 400 and the sealing sponge 200; the fixing pad 110 is provided with a pre-tightening hole 111, and the second thread end 420 of the suture 400 is movably passed through the pre-tightening hole 111; the first thread end 410 of the suture 400 is used to be fixed with respect to the fixing pad 110 in a state where the second thread end 420 of the suture 400 is tensioned; the elastic fixing knot 120 is used for being located between the sealing sponge 200 and the fixing pad 110 in a state that the second string end 420 of the suture 400 is not tensioned, or the elastic fixing knot 120 is used for being pressed through the pre-tensioning hole 111 in a state that the second string end 420 of the suture 400 is tensioned, so as to press the fixing pad 110 from a side of the fixing pad 110 away from the sealing sponge 200, thereby tightening the sealing patch 300 and the sealing sponge 200.

Referring to fig. 4, the elastic fixing knot 120 is fixed to the suture 400, and in a state where the second end 420 of the suture 400 is pulled upward, the elastic fixing knot 120 is tightly clamped to the clamping ring 411, and referring to fig. 2 and 3, under the pressing action of the sealing sponge 200, the elastic fixing knot 120 is fixed in position without coming off the clamping ring 411, so that the fixation of the suture 400 can be realized, and the sealing sponge 200 and the sealing patch 300 are tightened.

The fixing pad 110 has two states, in a state that the second thread end 420 of the suture 400 is not tensioned, the fixing pad 110 is located between the elastic fixing knot 120 and the clamping ring 411, that is, the clamping ring 411, the fixing pad 110 and the elastic fixing knot 120 are arranged in sequence from top to bottom. In the state that the second end 420 of the suture 400 is tensioned, the fixing pad 110 is located between the sealing sponge 200 and the elastic fixing knot 120, that is, the suture 400 is tensioned to drive the elastic fixing knot 120 to move upwards and then to extrude through the pre-tightening hole 111, after the suture is completely tensioned, the elastic fixing knot 120 is located at the upper part of the fixing pad 110, and then the fixing pad 110, the sealing sponge 200 and the sealing patch 300 are pressed downwards to realize that the sealing device is integrated and fixed. The fixing pad 110 is tightly fastened to the elastic fixing knot 120 by tightening the suture 400.

In this embodiment, the blood vessel wound sealing device 10 further includes a pre-tightening rod, when the second thread end 420 of the suture 400 is pulled, the fixing pad 110 may be pressed downward by the pre-tightening rod to press the elastic fixing knot 120, so that the fixing pad 110 is tightly fixed between the elastic fixing knot 120 and the sealing sponge 200, and the elastic fixing knot 120 and the clamping ring 411 may be fixed.

It should be noted that: the following embodiments may be used to "fix the first thread end 410 of the suture 400 with respect to the fixing pad 110 in a state where the second thread end 420 of the suture 400 is tensioned.

First embodiment, referring to fig. 22, in this embodiment, a first thread end 410 of suture 400 forms a clamping ring 411; the clamping ring 411 is movably sleeved around the fixed gasket 110 between the second end 420 of the suture 400 and the fixed gasket 110.

Specifically, "clamp ring 411" is a ring formed by first wire end 410 being wrapped. In the case of tightening the second string end 420 of the suture 400, the clamping ring 411 is positioned above the fixing pad 110, and after the elastic fixing knot 120 is pressed through the pre-tightening hole 111, the elastic fixing knot 120 and the clamping ring 411 press and fix the sealing sponge 200 and the fixing pad 110.

In the first embodiment, the first end 410 of the suture 400 may or may not pass through the sealing sponge 200. Referring to fig. 22, in the present embodiment, a suture 400 is passed through the sealing sponge 200. A first end 410 of the suture 400 is threaded through the sealing sponge 200. Referring to fig. 23, the suture 400 does not pass through the sealing sponge 200. The first end 410 of the suture 400 bypasses the sealing sponge 200 and the fixed gasket 110 is movably sleeved between the second end 420 of the suture 400 and the fixed gasket 110. It is achieved that the first end 410 of the suture 400 is secured relative to the fixation pad 110 with the second end 420 of the suture 400 taut.

Second embodiment, referring to fig. 24, in this embodiment, a first thread end 410 of suture 400 forms a clamping ring 411; the fixed shim 110 is provided with a through hole 113, and the clamping ring 411 is movably sleeved between the second thread end 420 of the suture 400 and the fixed shim 110 after movably passing through the through hole 113.

In the second embodiment, the first thread end 410 of the suture 400 may or may not pass through the sealing sponge 200.

Third embodiment referring to fig. 25, in this embodiment, a first thread end 410 of a suture 400 is secured to a fixation pad 110. It is also possible that the first thread end 410 of the suture 400 forms a clamping ring 411, the clamping ring 411 being fixed to the fixation washer 110. Likewise, in the third embodiment, the first thread end 410 of the suture 400 may or may not pass through the sealing sponge 200.

Referring to fig. 5, 6 and 7, in the present embodiment, the pre-tightening hole 111 has a first hole end and a second hole end opposite to each other, the first hole end is far away from the sealing sponge 200 relative to the second hole end, the hole diameter of the first hole end is smaller than that of the second hole end, and the hole diameter of the first hole end is smaller than that of the elastic fixing knot 120.

Specifically, the pre-tightening hole 111 has a tapered structure. The elastic fixing knot 120 has elasticity, and the elastic fixing knot 120 is pressed into the pre-tightening hole 111 from the second hole end, pressed out from the first hole end, and then clamped and fixed between the first hole end and the clamping ring 411. Because the diameter of the first hole end is smaller than that of the elastic fixing knot 120, the first hole end can prevent the elastic fixing knot 120 from dislocating, and simultaneously can tightly fix the fixing gasket 110 between the sealing sponge 200 and the elastic fixing knot 120 to prevent the sealing sponge 200 from dislocating.

Referring to fig. 5, in the present embodiment, the upper surface and the lower surface of the fixing gasket 110 are respectively provided with the reinforcing ribs, so as to improve the strength of the fixing gasket 110 and ensure the structural strength of the fixing gasket 110.

Referring to fig. 8, 9 and 10, in the present embodiment, the vascular wound sealing device 10 further includes a reinforcing rib net 112, and the reinforcing rib net 112 is disposed in the fixing pad 110, so as to enhance the strength of the fixing pad 110. Specifically, the number of the reinforcing mesh 112 is plural, each reinforcing mesh 112 is in a hollow cylindrical shape, and the plurality of reinforcing meshes 112 in a hollow cylindrical shape are arranged in the fixing pad 110 at intervals. The strength of the fixing pad 110 is improved.

Referring to fig. 11, in the present embodiment, the sealing sponge 200 has a first sponge end and a second sponge end opposite to each other; the second sponge end is adapted to engage the outer wall of the blood vessel 20, and the cross-sectional area of the first sponge end is greater than the cross-sectional area of the second sponge end.

Referring to the relative position in fig. 11, the upper end of the sealing sponge 200 is a first sponge end, and the lower end of the sealing sponge 200 is a second sponge end. The sealing sponge 200 is of a trapezoidal structure, and the width of the second sponge end of the sealing sponge 200 is small, so that the blood vessel wound 23 can be sealed, the wound is not squeezed, and the healing of the blood vessel wound 23 is not affected; the wider first sponge end of the sealing sponge 200 can be matched with the tissue 30, and referring to fig. 2, a larger blood flow plugging area is realized, the hemostatic area is increased, and the plugging effect is improved. The gradually-wide gradient design can improve the plugging volume and the hemostatic effect while plugging the blood vessel wound 23.

Referring to fig. 11, in the present embodiment, the sealing sponge 200 includes a plurality of folding portions 220 connected in sequence, and the plurality of folding portions 220 are sequentially stacked in a direction from the second sponge end to the first sponge end. The sealing sponge 200 is of a trapezoidal multilayer structure, is formed by sequentially stacking a plurality of sequentially connected folding parts 220, is convenient to process, and is simple in manufacturing process.

Referring to fig. 12, in other embodiments, the sealing sponge 200 has a trapezoidal structure, and the sealing sponge 200 has a trapezoidal vertical section. Referring to fig. 13, in other embodiments, the sealing sponge 200 has a circular truncated cone shape, that is, the cross section of the sealing sponge 200 has a circular shape.

Referring to fig. 14, in other embodiments, the sealing sponge 200 includes a plurality of disc portions 230 having a gradually increasing diameter, and the plurality of disc portions 230 are sequentially stacked in a direction from the second sponge end to the first sponge end. The number of the disc parts 230 can be increased or decreased as required to adjust the size of the sealing sponge 200, so that the sealing sponge is suitable for treating more vascular wounds 23 and meets different clinical requirements.

In other embodiments, the sealing sponge 200 may have a structure with the same width from the first sponge end to the second sponge end. Namely, the collagen with the same width is stacked, the collagen with the same width is flaky, cylindrical and circular.

Referring to fig. 15, in the present embodiment, the sealing patch 300 is provided with a blood flow channel 320, and the blood flow channel 320 is used for the blood flow in the blood vessel 20.

The sealing patch 300 is provided with a blood flow channel 320, the blood flow channel 320 is a pressure reduction channel, blood pressure in an artery can flow through the blood flow channel 320, the impact of blood flow in the blood vessel 20 on the sealing patch 300 is reduced, and the pressure on the sealing patch 300 is reduced; meanwhile, the influence of blood flow in the blood vessel 20 on the position stability of the sealing patch 300 is reduced, and the sealing patch 300 is ensured to be stably and firmly attached to the inner wall of the blood vessel 20.

Referring to fig. 2 and 15, in the present embodiment, the sealing sponge 200 is provided with a first suture hole 210; the sealed patch 300 is provided with a second suture hole 310 and a third suture hole 311 at intervals; the second end 420 of the suture 400 is movably inserted through the first suture hole 210, and the suture 400 is movably inserted through the second suture hole 310 and the third suture hole.

Referring to fig. 15, in particular, the second suture hole 310 and the third suture hole 311 are symmetrically disposed with respect to the middle of the sealing patch 300, which can ensure that the sealing patch 300 can be balanced without bending when the suture 400 is in a tensioned state.

Referring to fig. 15, in particular, the sealing patch 300 has an upper surface and a lower surface that are opposite in position, the upper surface being configured to engage the inner wall of the blood vessel 20. The upper surface of the sealed patch 300 is provided with a first handle and a second handle at intervals, the first handle is provided with a second suture hole 310, the second handle is provided with a third suture hole 311, and a suture 400 sequentially passes through the second suture hole 310 and the third suture hole 311 to connect the sealed patch 300.

Referring to fig. 16 and 17, in another embodiment, the sealing patch 300 is provided with a first U-shaped hole and a second U-shaped hole at intervals, two ends of the first U-shaped hole form two second suture holes 310 on the upper surface of the sealing patch 300, two ends of the second U-shaped hole form two third suture holes 311 on the upper surface of the sealing patch 300, and the suture 400 sequentially passes through the first U-shaped hole and the second U-shaped hole.

In other embodiments, the sealing patch 300 is provided with a U-shaped suture 400 channel, both ends of the U-shaped suture 400 channel form a second suture hole 310 and a third suture hole 311 on the upper surface of the sealing patch 300, and the suture 400 passes through the U-shaped suture 400 channel from the second suture hole 310 and out from the third suture hole 311.

Referring to fig. 15, in the present embodiment, the sealing patch 300 has an upper surface and a lower surface opposite to each other, the upper surface is used for adhering to the inner wall of the blood vessel 20, and the lower surface is provided with a reinforcing rib portion 330.

Specifically, the upper surface is a smooth plane, so that better fitting with the upper wall 21 of the blood vessel can be realized, and the blood outflow is reduced. Because of in the process of shutoff vascular wound 23, need carry out the pretension to sealed paster 300 through suture 400, make the better laminating blood vessel 20 inner wall of sealed paster 300, lower surface design strengthening rib portion 330 can improve the intensity of sealed paster 300, when guaranteeing that suture 400 draws closely sealed paster 300, sealed paster 300 can not be bent the damage, leads to sealed inefficacy.

Referring to fig. 16, in this embodiment, the vascular wound sealing device 10 further includes an absorbable reinforcing wire mesh; a reinforcing wire mesh is provided within the sealing patch 300. By providing an absorbable reinforcing wire mesh inside the sealing patch 300, the strength of the sealing patch 300 is improved. The reinforcing wire mesh is a mesh structure woven from absorbable reinforcing wires, and is arranged inside the sealing patch 300, which can improve the strength of the sealing patch 300.

Referring to fig. 18, in the present embodiment, the sealing patch 300 includes a first sealing portion 361, an intermediate portion 362 and a second sealing portion 363 which are sequentially connected, the first sealing portion 361 and the second sealing portion 363 are symmetrically disposed with respect to the intermediate portion 362, and an edge of the intermediate portion 362 is protruded with respect to edges of the first sealing portion 361 and the second sealing portion 363.

Specifically, the middle portion 362 is in the shape of a strip, and the first sealing portion 361 and the second sealing portion 363 are both in the shape of a semicircle. The edge protrusion setting of the relative first sealing 361 of both ends of intermediate portion 362 and second sealing 363, sealing patch 300 when laminating with blood vessel 20 inner wall, the laminating area of intermediate portion 362 and blood vessel 20 inner wall is bigger, can provide better support effect to improve the effect of sealed laminating, thereby improve the sealed effect of blood vessel wound 23.

Specifically, the outer edges of the first sealing portion 361, the middle portion 362 and the second sealing portion 363 all smoothly transition to avoid scratching the inner wall of the blood vessel 20.

Specifically, the sealing patch 300 further includes a sealing outer ring 360, wherein the first sealing portion 361, the middle portion 362 and the second sealing portion 363 are integrally formed, and the sealing outer ring 360 is disposed along outer edges of the first sealing portion 361, the middle portion 362 and the second sealing portion 363.

The outer sealing ring 360, the first sealing portion 361, the middle portion 362 and the second sealing portion 363 may be made of absorbable materials with the same strength, or absorbable materials with different strengths, which may include, but are not limited to: polylactic acid, polydioxanone, polyglycolide-L-lactide, collagen, gelatin protein, vegetable protein, etc., and can achieve a better effect of coating the blood vessel 20.

The "absorbable materials with different strengths are used for the seal outer ring 360, the first seal portion 361, the middle portion 362 and the second seal portion 363" includes but is not limited to the following cases:

first, the sealing outer ring 360 is a high-strength supporting part, and is realized by changing the material type or thickness, and the first sealing part 361, the middle part 362 and the second sealing part 363 are pasting parts, so that a good supporting effect is realized.

Second, the middle portion 362 is a high strength support portion that provides support to prevent the sealing patch 300 from pulling out of the vascular opening 23. The seal outer ring 360, the first seal portion 361, and the second seal portion 363 are low-strength adhesive portions.

Thirdly, the sealing outer ring 360 and the middle part 362 are high-strength supporting parts, and double supporting can be applied to the case that the vascular wound 23 is large. The first sealing part 361 and the second sealing part 363 are low-strength adhesive parts.

The high strength support portion may be formed of non-absorbable material, nitinol, stainless steel, titanium alloy, or the like.

Referring to fig. 19, the outer edges of the first sealing portion 361, the intermediate portion 362 and the second sealing portion 363 are smoothly transitioned. Referring to fig. 20, both ends of the middle portion 362 are arc-shaped and smoothly transition with the outer edges of the first sealing portion 361 and the second sealing portion 363. Referring to fig. 21, the protrusion of the intermediate portion 362 from the first and

second sealing portions

361 and 363 is larger than the protrusion of the intermediate portion 362 from the first and

second sealing portions

361 and 363 in fig. 20.

The sealing patch 300 may be 1-3mm larger in diameter size on one side than the vascular wound 23. The size of the fixing pad 110 is smaller than that of the sealing patch 300 and may be 1/4-1/2 of that of the sealing patch 300. Alternative configurations for the sealing patch 300 and the mounting pad 110 are designed to be circular, elliptical, rectangular, etc.

Referring to fig. 2 again, in this embodiment, the fixing gasket 110 is provided with a first guide wire channel, the sealing sponge 200 is provided with a second guide wire channel, the sealing patch 300 is provided with a third guide wire channel 350, the first guide wire channel, the second guide wire channel and the third guide wire channel 350 are sequentially communicated, and the first guide wire channel, the second guide wire channel and the third guide wire channel 350 are commonly used for a guide wire to pass through.

In the operation process, the guide wire can be drawn out from the first guide wire channel, the second guide wire channel and the third guide wire channel 350 after the sealing is finished, the guide wire in the operation is ensured to pass, the requirements of a clinician are met, and the operation safety is improved.

In order to prevent the guide wire passing through the fixing pad 110 from interfering with the elastic fixing knot 120 pressed through the pre-tightening hole 111, the present embodiment provides the following solutions.

In the first scheme, the first guide wire channel and the pre-tightening hole 111 are a hole, a guide groove which is communicated up and down is arranged on the inner wall of the pre-tightening hole 111, the elastic fixing knot 120 extrudes and penetrates through the pre-tightening hole 111, the guide wire penetrates through the guide groove, and the elastic fixing knot 120 and the guide wire are not interfered with each other.

In the second scheme, a notch is formed in a side portion of the elastic fixing knot 120, and the notch is used for forming a conduction channel between the notch and the pre-tightening hole 111 in a state that the elastic fixing knot 120 is extruded into the pre-tightening hole 111, and a guide wire passes through the conduction channel. Or the side of the elastic fixing knot 120 has a conducting side wall, and a conducting channel is formed between the conducting side wall and the pre-tightening hole 111 when the elastic fixing knot 120 is pressed into the pre-tightening hole 111, and the guide wire passes through the conducting channel. The elastic fixing knot 120 and the guide wire do not interfere with each other.

In the second scheme, the first guide wire channel and the pre-tightening hole 111 are a hole, the elastic fixing knot 120 is provided with a fourth guide wire channel, the guide wire movably passes through the fourth guide wire channel and the first guide wire channel, and the elastic fixing knot 120 and the guide wire are not interfered with each other in the process that the elastic fixing knot 120 extrudes and passes through the pre-tightening hole 111.

Specifically, the second guide wire channel and the first suture hole 210 are one hole.

Specifically, the third guide wire channel 350 is disposed in the middle of the sealing patch 300, and the third guide wire channel 350 is located between the second suture hole 310 and the third suture hole 311.

In this embodiment, the sealing patch 300 has a circular shape. The center of the second wire guide channel coincides with the center of the sealing patch 300.

According to the blood vessel wound sealing device 10 provided by the embodiment, the working principle of the blood vessel wound sealing device 10 is as follows: the sealing patch 300 is tightly attached to the inner wall of the blood vessel 20 under the action of the blood pressure in the blood vessel 20, the sealing sponge 200 expands when meeting blood volume, and can absorb the blood exuded from the blood vessel wound 23, after the operation is finished, the peripheral tissue 30 can press the sponge to form tight sealing, so that the blood in the blood vessel 20 is prevented from flowing out; the pre-tightening assembly 100 clamps and fixes the sealing patch 300, the sealing sponge 200 and the wall of the blood vessel 20, so as to realize stable hemostasis. The volume of the sealing sponge 200 after blood suction expands to be larger than the size of the blood vessel wound 23, so that fixation is realized.

The blood vessel wound sealing device 10 provided by the embodiment has at least the following advantages:

the sealing patch 300 seals the inner wall of the blood vessel 20, the sealing sponge 200 seals the outer wall of the blood vessel 20, the pre-tightening component 100 is pre-tightened above, and the suture 400 connects the sealing patch 300 and the sealing sponge 200 into a whole, so that the effect of sealing the blood vessel 20 is realized, and the operation is simple and time-saving.

Embodiments of the present invention also provide a method of sealing a vascular wound 23. The method for sealing the vascular wound 23 is implemented by using the vascular wound sealing device 10, and comprises the following steps: the sealing sponge 200 is operated to be positioned on the outer wall of the blood vessel 20 of the sample; manipulating the sealing patch 300 to locate the inner wall of the blood vessel 20 of the sample; the suture 400 is manipulated to be tightened and the pretensioning assembly 100 is manipulated to secure the suture 400, thereby pulling the sealing patch 300 and sealing sponge 200 to pinch-seal the vessel wound 23 from the inside and outside of the vessel 20, respectively.

The sealing sponge 200 is attached to the inner wall of the blood vessel 20 through the sealing patch 300, the outer wall of the blood vessel 20 is sealed by the sealing sponge 200, the suture 400 is fixed through the pre-tightening assembly 100, the sealing sponge 200 and the sealing patch 300 are connected to form the inner side and the outer side of the blood vessel wound 23 which are integrally sealed, and the hemostatic effect is achieved.

The above description is only for the specific embodiments of the present invention, but the scope of the present invention is not limited thereto, and any changes or substitutions that can be easily conceived by those skilled in the art within the technical scope of the present invention are included in the scope of the present invention. Therefore, the protection scope of the present invention shall be subject to the protection scope of the claims.

Claims

1. A vascular wound sealing device for sealing a vascular wound (23) on a blood vessel (20), the vascular wound sealing device comprising:

a sealing patch (300), a sealing sponge (200), a suture (400), an elastic fixing knot (120) and a fixing gasket (110); the sealing patch (300), the sealing sponge (200) and the fixing gasket (110) are sequentially arranged, and the fixing gasket (110) is provided with a pre-tightening hole (111);

the sealing patch (300) is used for being attached to the inner wall of the blood vessel (20) so as to seal the blood vessel wound (23) from the inner side of the blood vessel (20); the sealing sponge (200) is used for adhering to the outer wall of the blood vessel (20) after being expanded so as to seal the blood vessel wound (23) from the outer side of the blood vessel (20);

the two ends of the suture (400) are respectively a first line end (410) and a second line end (420); the suture (400) is movably arranged on the sealing patch (300), and the second line end (420) movably penetrates out of the sealing patch (300) and movably passes through the sealing sponge (200) and the pre-tightening hole (111); the first thread end (410) movably penetrates out of the sealing patch (300) and is arranged on one side of the fixing gasket (110) far away from the sealing sponge (200), and the first thread end (410) is used for being fixed relative to the fixing gasket (110) under the condition that the second thread end (420) of the suture (400) is tensioned;

the elastic fixing knot (120) is fixed on the suture (400), the elastic fixing knot (120) is located between the fixing gasket (110) and the sealing sponge (200), and the elastic fixing knot (120) is used for being extruded to pass through the pre-tightening hole (111) under the state that the second line end (420) of the suture (400) is tensioned so as to press and fix the fixing gasket (110) from one side of the fixing gasket (110) far away from the sealing sponge (200), so that the sealing patch (300) and the sealing sponge (200) are tensioned to clamp and seal the blood vessel wound (23) from the inner side and the outer side of the blood vessel (20) respectively.

2. The vascular wound sealing device of claim 1, wherein:

the first thread end (410) of the suture (400) forming a clamping ring (411); the clamping ring (411) is movably sleeved around the fixed gasket (110) between the second end (420) of the suture (400) and the fixed gasket (110).

3. The vascular wound sealing device of claim 1, wherein:

the first thread end (410) of the suture (400) forming a clamping ring (411); the fixing gasket (110) is provided with a through hole (113), and the clamping ring (411) movably penetrates through the through hole (113) and then is movably sleeved between the second line end (420) of the suture (400) and the fixing gasket (110).

4. The vascular wound sealing device of claim 1, wherein:

the first end (410) of the suture (400) is secured with the fixation pad (110).

5. The vascular wound sealing device of claim 1, wherein:

the pre-tightening hole (111) is provided with a first hole end and a second hole end which are opposite in position, the first hole end is far away from the sealing sponge (200) relative to the second hole end, the aperture of the first hole end is smaller than that of the second hole end, and the aperture of the first hole end is smaller than that of the elastic fixing knot (120).

6. The vascular wound sealing device of claim 1, wherein:

the sealing sponge (200) is provided with a first suture hole (210); the sealing patch (300) is provided with a second suture hole (310) and a third suture hole (311) at intervals; the second end (420) of the suture (400) movably penetrates through the first suture hole (210), and the suture (400) movably penetrates through the second suture hole (310) and the third suture hole.

7. A vascular wound sealing device according to any of claims 1 to 6, wherein:

the sealing sponge (200) is provided with a first sponge end and a second sponge end which are opposite; the second sponge end is used for being attached to the outer wall of the blood vessel (20), and the cross-sectional area of the first sponge end is larger than that of the second sponge end.

8. The vascular wound sealing device of claim 7, wherein:

the sealing sponge (200) comprises a plurality of folding parts (220) which are connected in sequence, and the folding parts (220) are sequentially stacked in the direction from the second sponge end to the first sponge end.

9. The vascular wound sealing device of claim 7, wherein:

the sealing sponge (200) comprises a plurality of disc parts (230) with gradually increased diameters, and the disc parts (230) are sequentially stacked along the direction from the second sponge end to the first sponge end.

10. A vascular wound sealing device according to any of claims 1 to 6, wherein:

the sealing patch (300) is provided with a blood flow channel (320), the blood flow channel (320) being for the flow of blood within the blood vessel (20).

11. A vascular wound sealing device according to claim 10, wherein:

the sealing patch (300) is provided with an upper surface and a lower surface which are opposite in position, the upper surface is used for being attached to the inner wall of the blood vessel (20), and the lower surface is provided with a reinforcing rib part (330).

12. A vascular wound sealing device according to claim 10, wherein:

the vascular wound sealing device further comprises an absorbable reinforcing wire mesh; the reinforcing wire mesh is disposed within the sealing patch (300).

13. A vascular wound sealing device according to claim 10, wherein:

the sealing patch (300) comprises a first sealing part (361), an intermediate part (362) and a second sealing part (363) which are sequentially connected, wherein the first sealing part (361) and the second sealing part (363) are symmetrically arranged relative to the intermediate part (362), and the edge of the intermediate part (362) is convexly arranged relative to the edges of the first sealing part (361) and the second sealing part (363).

14. A vascular wound sealing device according to any of claims 1 to 6, wherein:

the utility model discloses a seal structure, including fixed gasket (110), sealed sponge (200), sealed paster (300), first seal structure, second seal structure, first seal structure, fixed gasket (110) are provided with first seal structure, sealed sponge (200) are provided with second seal structure, sealed paster (300) are provided with third seal structure (350), first seal structure second seal structure and third seal structure (350) communicate in proper order, first seal structure second seal structure and third seal structure (350) are used for supplying the seal wire to pass jointly.