WO2024131963A1 - Vascular suturing device and vascular suturing method - Google Patents

Abstract

A vascular suturing device, comprising: a suturing assembly (300), which comprises a first suturing member (310) and a second suturing member (320) arranged side-by-side, wherein the first suturing member (310) comprises a first tube body (311) and a suture needle (312), which are slidably connected to each other; the second suturing member (320) comprises a second tube body (321) and a fixing member (322), which are slidably connected to each other; the suture needle (312) is an elastic deformable member which can reset to a bent shape; the suturing assembly (300) comprises a first operating state in which the suture needle (312) is received in the first tube body (311) and deformed by force and a second operating state in which the suture needle (312) extends out of the first tube body (311) and resets to the bent shape; and a needle tip of the suture needle (312) can be in contact with and snap-fitted to the fixing member (322).

Description

Vascular suturing device and vascular suturing method

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to Chinese patent application 202211666174.2, filed on December 23, 2022, entitled “Vascular Suturing Device and Vascular Suturing Method,” the entire contents of which are incorporated herein by reference.

Technical Field

The present application belongs to the field of medical device technology, and in particular relates to a vascular suturing device and a vascular suturing method.

Background technique

In recent years, with the continuous improvement of living standards, the incidence of arteriosclerosis has gradually increased. Arteriosclerosis is a non-inflammatory disease of the arteries. It is usually caused by the deposition of lipid substances such as cholesterol on the inner wall of human blood vessels, which causes local necrosis of the blood vessel wall and accompanied by fibrous tissue hyperplasia, resulting in thickening and hardening of the arterial wall.

Surgical treatment of atherosclerosis includes surgical procedures such as recanalization, reconstruction or bypass transplantation of narrowed or occluded blood vessels. In the related art, interventional vascular suture devices are usually used to perform surgery on atherosclerosis cases. Interventional vascular suture devices can be divided into three categories: vascular suture devices based on sutures, vascular suture devices based on collagen degradable materials, and vascular suture devices based on metal degradable materials. However, when there is not enough space in the blood vessel, the vascular suture device based on sutures cannot unfold the internal mechanism and cannot suture the blood vessel wall; when the blood vessel wall is not flat enough, the vascular suture device based on collagen degradable materials and the vascular suture device based on metal degradable materials cannot be close to the blood vessel wall, making it impossible to seal and stop bleeding at the wound. Therefore, how to achieve vascular suture in surgical scenarios where existing vascular suture devices are difficult to operate has become an important research topic.

Summary of the invention

The embodiments of the present application provide a vascular suturing device and a vascular suturing method, which can flexibly and effectively achieve vascular suturing in a variety of surgical scenarios.

The embodiment of the first aspect of the present application provides a blood vessel suturing device, including a suturing assembly; the suturing assembly includes: a first suturing member, including a first tube body and a suturing needle slidably connected to the first tube body, the suturing needle is capable of resetting An elastic deformable part in a curved shape; and a second suturing part, arranged side by side with the first suturing part, the second suturing part includes a second tube body and a fixing part slidably connected to the second tube body; the suturing assembly includes a first operating state and a second operating state, in the first operating state, the suturing needle is accommodated in the first tube body and deformed by force; in the second operating state, the suturing needle extends out of the first tube body and resets to a curved shape, and the needle tip of the suturing needle can contact and engage with the fixing part.

In any of the aforementioned embodiments, the vascular suturing device also includes an anchoring assembly, which includes a third tube body, a deformable member and an acting member; the third tube body is fixedly connected to the introduction assembly, and the first suturing member and the second suturing member are slidably arranged side by side inside the third tube body; the deformable member is located at the distal end of the third tube body, and the deformable member includes a contracted state and an expanded state. In the contracted state, the deformable member does not protrude from the third tube body, and in the expanded state, the deformable member protrudes from the third tube body and abuts against the blood vessel wall; the acting member is connected to the deformable member, and the acting member is configured to act on the deformable member so that the deformable member switches between the contracted state and the expanded state.

In any of the aforementioned embodiments, the third tube body includes a first opening for the suture needle to slide through, the first opening is located at the distal end of the third tube body, at least partially penetrates the third tube body along the radial direction of the third tube body, and the deformable member is arranged at the first opening.

In any of the aforementioned embodiments, the deformable member includes a balloon, and the active member includes a balloon catheter.

In any of the aforementioned embodiments, the third tube body also includes a second opening and a third opening, the second opening is arranged on the side of the first opening away from the introduction component to allow the first suture piece to extend out or retract into the third tube body; the third opening and the second opening are arranged opposite to each other along the radial direction of the third tube body to allow the second suture piece to extend out or retract into the third tube body.

In any of the aforementioned embodiments, the suturing assembly further comprises a suture thread, one end of which is connected to the needle tail of the suture needle, and the other end of which is wound around the second tube body to form a knot that slides on the second tube body.

In any of the aforementioned embodiments, the first suturing member further comprises a first rod body, the first rod body is disposed inside the first tube body and is slidably connected to the first tube body, and the distal end of the first rod body is detachably connected to the needle tail of the suturing needle.

In any of the aforementioned embodiments, the suturing needle further includes a connecting piece, which is located at the needle tail of the suturing needle and is separable from the first rod body, and the connecting piece includes a thread hole.

In any of the aforementioned embodiments, the second suture member further includes a second rod body, which is disposed inside the second tube body and slidably connected to the second tube body, and the distal end of the second rod body is connected to the fixing member.

In any of the aforementioned embodiments, the suturing assembly further includes a third operating state. In the third operating state, the needle tail of the suturing needle is separated from the first tube body, the suturing needle is accommodated in the second tube body, and the suture thread passes through the prefabricated knot.

In any of the aforementioned embodiments, the vascular suturing device further includes an introduction component connected to the suturing component, the introduction component includes a catheter, and a guidewire cavity partially arranged along the axial direction of the catheter is opened in the introduction component.

In any of the aforementioned embodiments, the vascular suturing device further includes an operating component, which is connected to the first suturing member and the second suturing member, respectively, and is used to control the suturing component to switch from a first operating state to a second operating state.

The embodiment of the second aspect of the present application provides a vascular suturing method, which is implemented by any of the aforementioned vascular suturing devices, and the vascular suturing method includes: controlling the first suturing member and the second suturing member to extend out of the anchoring assembly; controlling the needle tip of the suturing needle to extend out of the first tube body and contact the fixing member to engage with the fixing member; controlling the needle tail of the suturing needle to separate from the first tube body, the fixing member and the suturing needle to retract into the second tube body, and allowing the suture thread to pass through the prefabricated knot.

The vascular suturing device provided in the embodiment of the present application includes a suturing assembly, which includes a first suturing member and a second suturing member arranged side by side, the first suturing member includes a first tube body and a suturing needle that are slidably connected, and the second suturing member includes a second tube body and a fixing member that are slidably connected. The suturing needle is an elastic deformable member that can be reset to a curved shape. During the suturing process, first, the suturing needle is accommodated in the first tube body and deformed under force, and the suturing assembly is in a first working state; then, the suturing needle extends out of the first tube body, resets to a curved shape, contacts and engages with the fixing member, and the suturing assembly is in a second working state. In the vascular suturing device of the embodiment of the present application, when the suturing assembly is converted from the first working state to the second working state, the suturing needle is converted from a state of being accommodated in the first tube body to a state of extending out of the first tube body, and pierces the blood vessel while resetting to a curved shape, thereby simplifying the process of vascular suturing, so that the vascular suturing device has good usability and can easily and effectively achieve vascular suturing in a variety of surgical scenarios.

BRIEF DESCRIPTION OF THE DRAWINGS

In order to more clearly illustrate the technical solution of the embodiments of the present application, the following is a brief introduction to the drawings required for use in the embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without any creative work.

FIG1 is a schematic structural diagram of a vascular suturing device provided by an embodiment of the present application;

FIG2 is a schematic diagram of the structure of a suturing assembly provided by an embodiment of the present application;

FIG3 is a schematic structural diagram of an anchor assembly provided by an embodiment of the present application;

FIG4 shows a schematic structural diagram of the third tube body in FIG3 ;

FIG5 is a schematic structural diagram showing an example of a deformable member and an action member in FIG3 ;

FIG6 is a schematic structural diagram showing another example of the deformable member and the action member in FIG3 ;

FIG7 is a schematic structural diagram showing another example of the deformable member and the action member in FIG3 ;

FIG8 is a schematic structural diagram of the first suture member in FIG2 ;

FIG9 shows a schematic structural diagram of the second suture member in FIG2 ;

FIG10 shows a cross-sectional view of an example of the connecting member in FIG8 along the axial direction;

FIG11 is a schematic structural diagram of an example of the suture needle in FIG8 ;

FIG12 is a schematic structural diagram of an example of the fixing member in FIG9 ;

FIG13 is a schematic structural diagram showing a suturing assembly in a first operating state;

FIG14 is a schematic diagram showing the structure of the suturing assembly in a second operating state;

FIG15 is a schematic structural diagram showing a suturing assembly in a third operating state;

FIG16 is a schematic diagram of the structure of an import component provided by an embodiment of the present application;

FIG17 shows a cross-sectional view of the catheter in FIG16 along the axial direction;

FIG18 shows a cross-sectional view of an example of the first portion in FIG17 along the axial direction;

FIG19 shows a cross-sectional view of an example of the second portion in FIG17 along the axial direction;

FIG20 shows a cross-sectional view along the axial direction of an example of the sealing assembly in FIG17;

FIG. 21 shows a radial cross-sectional view of an example of the sealing assembly in FIG. 22 ;

FIG22 is a schematic diagram of a scene in which a vascular suturing device provided by an embodiment of the present application is in a second surgical procedure;

FIG23 is a schematic diagram of a scene in which a vascular suturing device provided by an embodiment of the present application is in a fourth surgical procedure;

FIG24 is a schematic diagram of a flow chart of a blood vessel suturing method provided in one embodiment of the present application;

FIG. 25 shows an exemplary schematic diagram of the flow diagram shown in FIG. 24 .

In the attached figure:
1000-Vascular suture device;
100-introduction component; 110-catheter; 1101-guidewire cavity; 111-first part; 112-second part; 113-seal; 1131-tangent;
200 - anchoring assembly; 210 - third tube body; 211 - first opening; 212 - second opening; 213 - third opening;
220-deformable member; 230-acting member; a-contracted state; b-expanded state;
300- suture assembly; 310- first suture piece; 311- first tube body; 312- suture needle; 3121- connecting piece;
3122-thread hole; 3123-first matching part; 313-first rod body; 3131-first sub-rod; 3132-first sub-tube; 320-second suture piece; 321-second tube body; 322-fixing piece; 3221-second matching part; 323-second rod body; 330-suture thread; i-first working state; ii-second working state; iii-third working state;
400 - Operation component.

Detailed ways

In order to more clearly understand the above-mentioned purposes, features and advantages of the present application, the scheme of the present application will be further described below. It should be noted that the embodiments of the present application and the features in the embodiments can be combined with each other without conflict.

In the following description, many specific details are set forth to facilitate a full understanding of the present application, but the present application may also be implemented in other ways different from those described herein; obviously, the embodiments in the specification are only part of the embodiments of the present application, rather than all of the embodiments.

It should be noted that, unless otherwise specified, the technical terms or scientific terms used in the embodiments of the present application should have the common meanings understood by technicians in the field to which the embodiments of the present application belong.

In addition, the technical terms "first", "second", etc. are used for descriptive purposes only and cannot be understood as indicating or implying relative importance or implicitly indicating the number of the indicated technical features. In the description of the embodiments of the present application, the meaning of "multiple" is more than two, unless otherwise clearly and specifically defined.

In the description of the embodiments of the present application, unless otherwise clearly specified and limited, technical terms such as "installed", "connected", "connected", "fixed" and the like should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, and it can be the internal connection of two elements or the interaction relationship between two elements. For ordinary technicians in this field, the specific meanings of the above terms in the embodiments of the present application can be understood according to the specific circumstances.

Fig. 1 is a schematic diagram of the structure of a vascular suturing device 1000 provided in one embodiment of the present application. As shown in Fig. 1 , the vascular suturing device 1000 includes an introduction component 100, an anchoring component 200, a suturing component 300, and an operating component 400.

The introduction component 100 is configured to extend into the blood vessel along the guide wire to introduce the blood vessel suturing device 1000 to a predetermined position, the anchoring component 200 is configured to fix the relative position of the blood vessel suturing device 1000 and the blood vessel, the suturing component 300 is configured to suture the blood vessel wall, and the operating component 400 is configured to control the anchoring component 200 and related components of the suturing component 300 to perform operations in predetermined steps.

Fig. 2 is a schematic diagram of the structure of a suturing assembly 300 provided in an embodiment of the present application. As shown in Fig. 2 , the suturing assembly 300 includes a first suturing piece 310 and a second suturing piece 320 .

The first suture piece 310 is slidably disposed on the anchor assembly 200. The first suture piece 310 includes a first tube body 311 and a suture needle 312 slidably connected to the first tube body 311. The suture needle 312 is an elastic deformable member that can be reset to a curved shape. The second suture piece 320 is slidably disposed on the anchor assembly side by side with the first suture piece 310. The second suture piece 320 includes a first tube body 311 and a suture needle 312 slidably connected to the first tube body 311. The suture needle 312 is an elastic deformable member that can be reset to a curved shape. The second tube body 321 includes a second tube body 321 and a fixing member 322 slidably connected to the second tube body 321 .

When the first tube 311 and the second tube 321 are slidably connected to the anchor assembly 200, the first suture member 310 and the second suture member 320 can extend or retract from the anchor assembly 200. When the suture needle 312 and the fixing member 322 are slidably connected to the first tube 311 and the second tube 321, respectively, the suture needle 312 and the fixing member 322 can extend from the first tube 311 and the second tube 321, respectively, so as to extend from the anchor assembly 200 to suture the blood vessel.

The suturing assembly 300 includes a first operating state i and a second operating state ii. In the first operating state i, the suturing needle 312 is accommodated in the first tube body 311 and deformed under force. In the second operating state ii, the suturing needle 312 extends out of the first tube body 311 and returns to a bent shape. The needle tip of the suturing needle 312 can contact and engage with the fixing member 322.

The shape of the suture needle 312 can be an arc shape, or it can be composed of different straight line segments and arcs. In one example, the suture needle 312 is an arc shape, which is deformed into a straight line in the first working state i of the suture assembly 300, and is reset to an arc shape in the second working state ii. That is to say, during the operation, the suture needle 312 is first located in a straight line inside the first tube body 311, and at this time, the suture assembly 300 is in the first working state i. Afterwards, the suture needle 312 and the fixing member 322 are respectively extended out of the first tube body 311 and the second tube body 321, and the suture needle 312 is restored to an arc shape, and at this time, the suture assembly 300 is converted to the second working state ii. Since the positions of the suture needle 312 and the fixing member 322 correspond, the needle tip of the suture needle 312 can contact and engage with the fixing member 322.

The suture assembly 300 further includes a suture thread 330, one end of which is connected to the needle tail of the suture needle 312, and the other end is wound around the second tube 321 to form a prefabricated knot that can slide on the second tube 321. Optionally, the prefabricated knot that the suture thread 330 can form on the second tube 321 can be a fisherman's knot. After one end of the suture thread 330 connected to the needle tail of the suture needle 312 passes through the prefabricated knot, a knot can be formed for tying a blood vessel. The prefabricated knot can reduce the difficulty of the doctor's operation and improve the stability of the blood vessel suture to ensure the hemostatic effect.

It should be understood that in the embodiment of the present application, the needle tip and the needle tail of the suture needle 312 are relative to each other. The needle tip of the suture needle 312 is the end of the suture needle 312 that first extends out of the first tube body 311, including a sharp shape to pierce the blood vessel wall, and the needle tail is the other end relative to the needle tip, which is connected to the suture thread 330.

Fig. 3 is a schematic diagram of the structure of an anchor assembly 200 provided in an embodiment of the present application. As shown in Fig. 3, in some embodiments of the present application, the anchor assembly 200 includes a third tube 210, a deformable member 220 and an action member 230.

The third tube 210 is fixedly connected to the introduction assembly 100 and is at least partially hollow. During the operation, at least a portion of the third tube 210 enters the blood vessel along with the introduction assembly 100. The first suture piece 310 and the second suture piece 320 are slidably arranged side by side inside the third tube 210, that is, they can extend or retract in the third tube 210.

The deformable member 220 is located at the distal end of the third tube body 210. It should be understood that in the embodiment of the present application, the reference objects of the proximal end and the distal end are the user operating the vascular suturing device 1000, the proximal end is the end of the vascular suturing device 1000 close to the user, and the distal end is the end of the vascular suturing device 1000 away from the user.

The deformable member 220 includes a contracted state a and an expanded state b. In the contracted state a, the deformable member 220 does not protrude from the third tube body 210, for example, the deformable member 220 can be accommodated inside the third tube body 210. In the expanded state b, the deformable member 220 protrudes from the third tube body 210 and abuts against the blood vessel wall. The deformable member 220 is located at the end where the third tube body 210 is connected to the introduction component 100. In the case where the third tube body 210 at least partially enters the blood vessel with the introduction component 100, the deformable member 220 can also enter the blood vessel. In the process of entering the blood vessel, in order to avoid hindering the third tube body 210, the deformable member 220 does not protrude from the third tube body 210, that is, it is in the contracted state a. After entering the blood vessel, the deformable member 220 protrudes from the third tube 210, that is, it is in the expanded state b. At this time, the volume of the deformable member 220 increases, and the anchoring assembly 200 is moved toward the proximal end, so that the deformable member 220 adjusts its position and abuts against the blood vessel wall. At this time, the anchoring assembly 200 cannot be withdrawn from the puncture hole, so it can play a better anchoring role. In addition, while anchoring the blood vessel, the abutted blood vessel can be tensioned, so that the suture needle 312 can puncture the blood vessel more easily. The deformable member 220 shown in FIG. 8 is in the expanded state b.

The action member 230 is connected to the deformable member 220, and the action member 230 is configured to act on the deformable member 220, so that the deformable member 220 switches between the contracted state a and the expanded state b. Since the deformable member 220 switches from the contracted state a to the expanded state b only after entering the blood vessel, and needs to switch from the expanded state b to the contracted state a after the operation is completed, so as to stop anchoring and be withdrawn from the blood vessel, it is necessary to enable the deformable member 220 to switch between the two states from outside the body. Therefore, the action member 230 can pass through the other end of the third tube 210, and be connected to the deformable member 220 from the inside of the third tube 210, so as to operate the deformable member 220.

Fig. 4 is a schematic diagram of the structure of the third tube body 210 in Fig. 3. As shown in Fig. 4, the third tube body 210 includes a first opening 211, which is located at the distal end of the third tube body 210 and at least partially penetrates the third tube body 210 along the radial direction of the third tube body 210, and the deformable member 220 is disposed at the first opening 211.

In order to enable the deformable member 220 to enter the blood vessel, the third tube 210 is provided with a first opening 211. When the third tube 210 has not entered the blood vessel, the deformable member 220 is arranged inside the first opening 211 in a contracted state a. In the case where the third tube 210 enters the blood vessel along with the introduction component 100, the first opening 211 arranged at one end of the third tube 210 close to the introduction component 100 also enters the blood vessel, and therefore, the deformable member 220 is also located inside the blood vessel. Afterwards, the action member 230 acts on the deformable member 220 to convert it to an expanded state b, so that it protrudes from the third tube 210 through the first opening 211 and abuts against the blood vessel wall. In some optional embodiments, the first opening 211 radially penetrates the third tube 210 so that The deformable member 220 can protrude from the third tube body 210 from both sides in the expanded state b, so as to prevent the deformable member 220 from protruding from the third tube body 210 only from one side, thereby pushing the third tube body 210 onto the blood vessel wall and causing damage to the blood vessel wall.

Referring again to FIG. 1 , in some embodiments of the present application, an angle β is formed between the third tube 210 and the catheter 110. In one example, the angle β can be formed by the third tube 210, that is, the end of the third tube 210 connected to the catheter 110 is bent and forms a certain angle β with the other parts of the third tube 210. When the third tube 210 part enters the blood vessel with the catheter 110, the third tube 210 is connected to the catheter 110 at a certain angle β, which can adapt to the blood vessel environment and facilitate the operation of the components accommodated in the third tube 210 during subsequent surgical procedures. Optionally, the angle β can be any angle between 0° and 180°, and there is no angle restriction on the vascular suturing, and the vascular suturing operation can be achieved under the conditions of various angles.

FIG5 is a schematic structural diagram of an example of the deformable member 220 and the action member 230 in FIG3. As shown in FIG5, in some optional embodiments, the deformable member 220 includes a balloon, and the action member 230 includes a balloon catheter. The volume of the balloon can be adjusted by filling the balloon with liquid or gas, or extracting the liquid or gas in the balloon through the balloon catheter. In the contracted state a, the balloon can be folded and accommodated in the first opening 211, and in the expanded state b, the balloon can be expanded by the action of filling the balloon catheter with liquid or gas, and protrude from the first opening 211.

Optionally, the balloon includes at least one valve. Optionally, in the expanded state b, the balloon may be hemispherical, or may have an undulating shape on the spherical surface to allow blood to flow through. Optionally, the multi-valve balloon may be connected to multiple balloon catheters, or may be shunted to the multi-valve balloon through one balloon catheter. The embodiments of the present application do not limit any feasible settings.

FIG6 shows a schematic structural diagram of another example of the deformable member 220 and the action member 230 in FIG3 . As shown in FIG6 , in other optional embodiments, the deformable member 220 includes a deformable stent structure, and the action member 230 includes a traction wire. The stent structure can connect the front and rear parts of the third tube 210, and it can be imagined that at this time, the third tube 210 may not include the first opening 211. In the contraction state a, the stent structure is arranged in the third tube 210 in the initial state, and in the expansion state b, the traction wire pushes the rear part of the third tube 210, so that the stent structure increases in radial dimension and decreases in axial dimension to abut against the blood vessel wall, thereby playing an anchoring role. In the case where the deformable member 220 is a stent structure, even if the deformable member 220 is in the expansion state b, blood flow can pass through between the stents. Optionally, the stent structure can be made of memory alloy. The deformable member 220 shown in FIG11 is in the contraction state a.

FIG7 shows a schematic diagram of another example of the structure of the deformable member 220 and the action member 230 in FIG3. As shown in FIG7, in some other optional embodiments, the deformable member 220 includes a plurality of deformable diaphragms, and the action member 230 includes a traction wire. The diaphragms can connect the front and rear parts of the third tube 210. It can be imagined that at this time, the third tube 210 is also The first opening 211 may not be included. In the contracted state a, the diaphragm is arranged in the initial state on the third tube body 210, and in the expanded state b, the traction wire pushes the rear part of the third tube body 210, so that multiple diaphragms protrude radially outward to abut against the blood vessel wall, thereby playing an anchoring role. In the case where the deformable member 220 is a diaphragm, blood flow can pass between multiple diaphragms. Optionally, the diaphragm structure can be cut from a polymer material. The deformable member 220 shown in FIG. 12 is in the contracted state a.

Referring to Figure 4 again, in some embodiments of the present application, the third tube body 210 also includes a second opening 212 and a third opening 213. The second opening 212 is arranged on the side of the first opening 211 relative to the introduction component 100 to allow the first suture piece 310 to extend out or retract into the third tube body 210. The third opening 213 is radially arranged on the tube wall of the third tube body 210 opposite to the second opening 212 to allow the second suture piece 320 to extend out or retract into the third tube body 210.

That is, the first suture member 310 and the second suture member 320 can extend out of the third tube 210 from the second opening 212 and the third opening 213 respectively. In order to allow the suture needle 312 and the fixing member 322 to contact each other and engage with each other, the second opening 212 and the third opening 213 are oppositely arranged along the radial direction of the third tube 210, adjacent to the first opening 211.

Since the second opening 212 and the third opening 213 are arranged at positions close to the first opening 211, when the suture needle 312 extends out of the second opening 212, so that the suture assembly 300 enters the second operation state ii, the suture needle 312 restores the bent shape and moves toward the first opening 211, and passes through the first opening 211 to contact the fixing member 322 extending out of the third opening 213. Therefore, the deformable member 220 may include a gap for the suture needle 312 to pass through in the expanded state b, and the gap corresponds to the first opening 211, so that the suture needle 312 can pass through the first opening 211, or the suture needle 312 can bypass the deformable member 220 to pass through the first opening 211. In some optional embodiments, the deformable member 220 is a balloon, and the balloon includes at least one petal. In one example, the balloon includes multiple petals. In the expanded state b, the multiple petals of the balloon include gaps for the suture needle 312 to pass through. In another example, the balloon includes one petal, and the suture needle 312 bypasses the balloon to pass through the first opening 211.

FIG8 is a schematic diagram showing the structure of the first suture piece 310 in FIG2 . FIG9 is a schematic diagram showing the structure of the second suture piece 320 in FIG2 . As shown in FIG8 and FIG9 , in some embodiments of the present application, the first suture piece 310 further includes a first rod 313, the first rod 313 is disposed inside the first tube 311 and is slidably connected to the first tube 311, and the distal end of the first rod 313 is detachably connected to the needle tail of the suture needle 312. The second suture piece 320 further includes a second rod 323, the second rod 323 is disposed inside the second tube 321 and is slidably connected to the second tube 321, and the distal end of the second rod 323 is connected to the fixing member 322.

The first rod 313 and the second rod 323 are slidably connected to the first tube 311 and the second tube 321 respectively. The suture needle 312 and the fixing member 322 can be pushed or pulled to extend or retract into the first tube body 311 and the second tube body 321 .

Fig. 10 shows an axial cross-sectional view of an example of the connecting member 3121 in Fig. 8. As shown in Fig. 10, in some embodiments of the present application, the suture needle 312 includes a connecting member 3121, which is located at the needle tail of the suture needle 312 and is detachable from the first rod 313.

In order to enable the suture needle 312 to be connected to the first rod 313, a connector 3121 is provided at the needle tail of the suture needle 312. In some examples, the connector 3121 can be engaged with the first rod 313, and when the fixing member 322 pulls the suture needle 312, the engagement with the first rod 313 fails, so as to be separated from the first rod 313.

In some embodiments of the present application, the connecting piece 3121 includes a thread hole 3122 , and the suture thread 330 is passed through the thread hole 3122 .

In some optional embodiments, the first rod body 313 may include a first sub-rod 3131 and a first sub-tube 3132, the first sub-rod 3131 is disposed inside the first sub-tube 3132 and is slidably connected to the first sub-tube 3132, the needle tail is connected to the first sub-tube 3132 and is detachable from the first sub-tube 3132, and the first sub-rod 3131 is against the needle tail.

After the needle tip of the suture needle 312 contacts and is connected with the fixing member 322, the suture needle 312 needs to be separated from the first tube 311, that is, separated from the end of the first rod 313, so that it can enter the second tube 321 with the fixing member 322. The first rod 313 includes a first sub-rod 3131 and a first sub-tube 3132. When the suture needle 312 is connected to the first sub-tube 3132, the suture needle 312 can be separated from the end of the first sub-tube 3132 by pushing the suture needle 312 through the first sub-rod 3131 inside the suture needle 312. Optionally, when the suture needle 312 includes a connecting member 3121, the connecting member 3121 can be engaged with the first sub-tube 3132, and the engagement with the first sub-tube 3132 fails under the push of the first sub-rod 3131, so as to be separated from the first sub-tube 3132.

Fig. 11 is a schematic structural diagram of an example of the suture needle 312 in Fig. 8. Fig. 12 is a schematic structural diagram of an example of the fixing member 322 in Fig. 9. As shown in Figs. 11 and 12, in some embodiments of the present application, the suture needle 312 includes a first matching portion 3123 located at the needle tip, and the fixing member 322 includes a second matching portion 3221. In the second operating state ii of the suture assembly 300, the first matching portion 3123 and the second matching portion 3221 are in contact with each other and fixedly connected.

In some examples, the first mating portion 3123 and the second mating portion 3221 can be formed as a block and a slot, respectively, which are engaged when in contact with each other to connect the suture needle 312 and the fixing member 322. It should be understood that since the first mating portion 3123 is located at the needle tip of the suture needle 312, the first mating portion 3123 should include a tip capable of piercing the blood vessel wall.

Optionally, the fixing member 322 may be integrally formed with the second rod body 323, that is, the end of the second rod body 323 may be The fixing member 322 is directly formed to be connectable to the suture needle 312 .

In order to tighten the suture thread 330 wound around the tail of the suture needle 312 and the second tube 321, in some embodiments of the present application, the suture assembly 300 also includes a third operating state iii, in which the tail of the suture needle 312 is separated from the first tube, the suture needle 312 is accommodated in the second tube 321 and deformed under force, and the suture thread 330 is accommodated in the prefabricated knot to form a knot for suture blood vessels. Optionally, the prefabricated knot can also be pushed toward the distal end of the second tube 321 to form a knot for suture blood vessels with the suture piece 330.

In the second working state ii of the suturing assembly 300, the suturing needle 312 contacts the fixing member 322 and is engaged with the fixing member 322, and the connecting member 3121 of the suturing needle 312 is pushed to separate from the first sub-tube 3132 by the first sub-rod 3131, that is, the suturing needle 312 is completely separated from the first tube body 311. Afterwards, the second rod body 323 is pulled so that the suturing needle 312 is retracted into the second tube body 321 along with the fixing member 322, and the suturing needle 312 is located inside the second tube body 321 and deformed by force, extending in a straight line. At this time, the suturing assembly 300 is in the third working state iii.

Therefore, the two ends of the suture thread 330 , namely the fisherman's knot located at the tail of the suture needle 312 and the second tube body 321 , can be knotted when the suture needle 312 enters the second tube body 321 .

FIG. 13 is a schematic diagram showing the structure of the suture assembly 300 when it is in the first working state i. FIG. 14 is a schematic diagram showing the structure of the suture assembly 300 when it is in the second working state ii. FIG. 15 is a schematic diagram showing the structure of the suture assembly 300 when it is in the third working state iii. Based on the above description, FIG. 13, FIG. 14 and FIG. 15 show the suture process of the suture assembly 300.

FIG. 16 is a schematic diagram of the structure of an introduction component 100 provided in an embodiment of the present application. FIG. 17 shows a cross-sectional view of the catheter 110 in FIG. 16 along the axial direction. As shown in FIG. 16 and FIG. 17, the introduction component 100 includes a catheter 110. A guidewire cavity 1101 partially arranged along the axial direction of the catheter 110 is provided in the catheter 110, and the guidewire cavity 1101 extends from the distal end of the catheter 110 to the wall of the proximal end of the catheter 110.

The guidewire is a thin and long metal wire that is inserted into the blood vessel through a puncture hole in the skin to perform diagnostic and therapeutic operations on the lesion location of the blood vessel. The guidewire can guide the catheter 110 so that the catheter 110 slides along the guidewire into the blood vessel. During the operation, the guidewire is first used to insert into the blood vessel. After the guidewire operation is completed, the catheter 110 is placed on the guidewire and enters the blood vessel through the internal guidewire cavity 1101. After the catheter 110 enters the blood vessel, the guidewire can be pulled out from the guidewire cavity 1101 of the catheter 110.

The two ends of the guidewire cavity 1101 are opened, one at the end of the catheter 110 away from the anchor assembly 200, and the other at the wall of the catheter 110 close to the anchor assembly 200. That is, a part of the guidewire cavity 1101 extends along the axial direction of the catheter 110, while the other part is at a certain angle to the former, so that when the catheter 110 and the anchor assembly 200 are connected to each other, This facilitates the guide wire to be withdrawn from the catheter 110.

In some optional embodiments, the catheter 110 includes a first portion 111 and a second portion 112 , and the first portion 111 , the second portion 112 are sequentially connected to the third tube body 210 of the anchor assembly 200 .

FIG18 shows an axial cross-sectional view of an example of the first portion 111 in FIG17 . As shown in FIG18 , in one example, the radial dimension of the first portion 111 gradually increases from the distal end to the proximal end, that is, the first portion 111 is a reducer. In another example, the radial dimension of a portion of the first portion 111 does not change, and the other portion gradually increases from the distal end to the proximal end, that is, at least part of the first portion 111 is a reducer. In the process of the catheter 110 entering the blood vessel along the guide wire, the end of the first portion 111 with a smaller diameter enters the blood vessel first, which can improve the efficiency of the catheter 110 entering the blood vessel.

FIG. 19 shows a cross-sectional view of an example of the second part 112 in FIG. 17 along the axial direction. As shown in FIG. 19, in one example, a portion of the guidewire cavity 1101 in the second part 112 extends along the axial direction of the catheter 110, and another portion extends toward the tube wall of the catheter 110, forming an opening for the guidewire to be extracted on the tube wall. In other words, to facilitate the extraction of the guidewire from the guidewire cavity 1101, a portion of the guidewire cavity 1101 is at a certain angle α with another portion, and optionally, the value range of the angle α can be between 100° and 170°. Further, a chamfer can be set between the two portions at an angle α to each other, so that the guidewire cavity 1101 is smoothly transitioned, thereby improving the efficiency of the process of extracting the guidewire from the catheter 110.

Fig. 20 shows an axial cross-sectional view of an example of the sealing assembly in Fig. 17. As shown in Fig. 20, in some embodiments of the present application, the catheter 110 further includes a sealing member 113, which is disposed inside the guidewire cavity 1101.

In one example, the seal 113 may be interference fit with the guidewire cavity 1101 in the circumferential direction. The seal 113 is arranged inside the guidewire cavity 1101, which can prevent blood from gushing out of the guidewire cavity 1101 when the catheter 110 enters the blood vessel. Optionally, the seal 113 can be arranged at any position of the guidewire cavity 1101, such as at the first part 111, or the second part 112, or between the first part 111 and the second part 112, as long as the sealing effect can be achieved, and the embodiment of the present application does not limit this.

Fig. 21 shows a radial cross-sectional view of an example of the sealing assembly in Fig. 22. As shown in Fig. 21, the sealing member 113 includes a tangent line 1131 for the guide wire to pass through. In the case where the sealing member 113 has a certain thickness, due to consideration of the surface tension of the sealing member 113, the extremely thin tangent line 1131 will not destroy the sealing property of the sealing member 113, and the guide wire can pass through the sealing member 113 through the tangent line 1131 and be slidably connected with the catheter 110.

The tangent line 1131 may be arranged in a variety of ways. In one example, at least one tangent line 1131 extends in a straight line along the radial direction of the seal 113 . In another example, the tangent line 1131 extends in a zigzag manner along the radial direction of the seal 113 .

Based on the above description, it can be imagined that in some embodiments of the present application, the operating assembly 400 and the first suture member The first suture member 310 and the second suture member 320 are respectively connected to each other, and are used to control the first suture member 310 and the second suture member 320 to extend from the tube wall of the third tube body 210 or retract into the third tube body 210. The operating assembly 400 can also control the suture needle 312 to extend out of the first tube body 311 and be connected to the fixing member 322, and control the fixing member 322 to pull the suture needle 312 to retract into the second tube body 321. In other words, the operating assembly 400 can control the suture assembly 300 to perform the suture process shown in Figures 13, 14 and 15.

In actual application, the blood vessel suturing method of the embodiment of the present application includes multiple surgical procedures.

During the first operation, the introduction component 100 enters the blood vessel along the guide wire, and the third tube body 210 partially enters the blood vessel along with the introduction component 100. In this process, the introduction component 100 and the third tube body 210 can be pushed into the blood vessel to a predetermined position.

FIG22 is a schematic diagram of a scene in which a vascular suturing device 1000 provided by an embodiment of the present application is in a second surgical procedure. As shown in FIG22 , during the second surgical procedure, the deformable member 220 in the first opening 211 of the third tube 210 is acted on by the action member 230, so that the deformable member 220 is converted from the contracted state a to the expanded state b. In this process, after the deformable member 220 is deformed, the third tube 210 can be moved proximally so that the deformable member 220 adjusts its angle and position to more closely fit against the inner wall of the blood vessel.

During the third operation, the first tube 311 and the second tube 321 extend out of the third tube 210 from the second opening 212 and the third opening 213 respectively. At this time, the suturing assembly 300 is in the first operation state i.

FIG23 is a schematic diagram of a scene in which the vascular suturing device 1000 provided by an embodiment of the present application is in a fourth surgical procedure. As shown in FIG23 , in the fourth surgical procedure, the suturing needle 312 extends out of the first tube 311, so that the suturing assembly 300 enters the second operating state ii, passes through the gap of the deformable member 220 and the first opening 211, and is engaged with the fixing member 322.

During the fifth operation, the tail of the suture needle 312 is separated from the first tube 311 , and the fixing member 322 and the suture needle 312 are pulled into the second tube 321 , so that the suture assembly 300 enters the third operation state iii.

At this point, it can be considered that the blood vessel suturing device 1000 has completed suturing the blood vessel. Optionally, the operating component 400 may also be used to control the first tube body 311 and the second tube body 321 to retract into the third tube body 210, and to trim the suture thread 330. After the trimming is completed, the action member 230 may act on the deformable member 220 again to convert the deformable member 220 from the expanded state b to the contracted state a, and the third tube body 210 and the introduction component 100 are sequentially withdrawn from the blood vessel. The embodiment of the present application is not limited to this.

Based on the above description, the embodiment of the present application further provides a blood vessel suturing method. Figure 24 is a flow chart of a blood vessel suturing method provided by an embodiment of the present application. As shown in Figure 24, the blood vessel suturing method includes the following steps.

S100 , controlling the first suture member 310 and the second suture member 320 to extend out of the anchor assembly 200 .

S200 , controlling the needle tip of the suture needle 312 to extend out of the first tube 311 and contact the fixing member 322 , so as to be engaged with the fixing member 322 .

S300, controlling the needle tail of the suture needle 312 to separate from the first tube body 311, retracting the fixing member 322 and the suture needle 312 into the second tube body 321, and passing the suture thread 330 through the prefabricated knot.

Fig. 25 shows an exemplary schematic diagram of the flow diagram shown in Fig. 24. As shown in Fig. 25, optionally, the blood vessel suturing method may further include the following steps.

Before step S100 , the blood vessel suturing method may further include the following steps.

S10, pushing the introduction component 100 and a portion of the third tube 210 into the blood vessel.

S20, controlling the deformation member 220 to transform from the contraction state a to the expansion state b.

After step S300 , the blood vessel suturing method may further include the following steps.

S400 , controlling the first tube 311 and the second tube 321 to retract into the anchoring assembly 200 .

S500 , controlling the deformation member 220 to transform from the expansion state b to the contraction state a.

S600, withdraw the third tube 210 and the introduction assembly 100 from the blood vessel.

In summary, the vascular suturing device 1000 provided in the embodiment of the present application includes an introduction component 100, an anchoring component 200, a suturing component 300 and an operating component 400. The third tube 210 of the anchoring component 200 is connected to the introduction component 100 and at least part of it enters the blood vessel with the introduction component 100. The suturing component 300 is located inside the third tube 210. During the suturing process, first, the first tube 311 and the second tube 321 of the first suturing member 310 and the second suturing member 320 extend out of the third tube 210 respectively, and the suturing needle 312 is accommodated in the first tube 311. The assembly 300 is in the first operating state i, and then the suture needle 312 extends out of the first tube 311 to pierce the blood vessel, and the suture assembly 300 is restored from the first operating state i to the second operating state ii, and the suture needle 312 contacts and engages with the fixing member 322, and then the suture needle 312 is pulled into the second tube 321 by the fixing member 322, and the suture assembly 300 enters the third operating state iii from the second operating state ii, so that the suture thread 330 connected to the needle tail passes through the prefabricated knot on the second tube 321 to form a knot for the blood vessel, thereby completing the suturing of the blood vessel. The blood vessel suturing device 1000 of the embodiment of the present application is easy to use, flexible, and has good usability.

It should be noted that, in this article, relational terms such as "first" and "second" are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any actual relationship or order between these entities or operations. Moreover, the term "include" or any other variation thereof is intended to cover non-exclusive inclusion, so that a process, method, article or device including a series of elements The term "comprising a device" refers to a process, method, article, or apparatus that includes not only those elements, but also other elements not explicitly listed, or elements inherent to such process, method, article, or apparatus. In the absence of further limitations, an element defined by the phrase "comprising a ..." does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes the element.

Claims (13)

1. A blood vessel suturing device, comprising a suturing assembly;

   The suturing assembly comprises:

   A first suturing member comprises a first tube body and a suturing needle slidably connected to the first tube body, wherein the suturing needle is an elastic deformable member capable of being reset to a bent shape; and

   A second suturing member, arranged side by side with the first suturing member, the second suturing member comprising a second tube body and a fixing member slidably connected to the second tube body;

   The suturing assembly includes a first operating state and a second operating state. In the first operating state, the suturing needle is accommodated in the first tube body and deformed under force; in the second operating state, the suturing needle extends out of the first tube body and is reset to a bent shape, and the needle tip of the suturing needle can contact and engage with the fixing member.
2. The vascular suturing device according to claim 1, wherein the vascular suturing device further comprises an anchoring assembly, wherein the anchoring assembly comprises a third tube, a deforming member, and an acting member;

   The third tube is fixedly connected to the introduction assembly, and the first suture piece and the second suture piece are slidably arranged side by side inside the third tube;

   The deformable member is located at the distal end of the third tube body, and the deformable member includes a contracted state and an expanded state. In the contracted state, the deformable member does not protrude from the third tube body, and in the expanded state, the deformable member protrudes from the third tube body and abuts against the blood vessel wall;

   The action member is connected to the deformable member, and is configured to act on the deformable member so that the deformable member switches between the contracted state and the expanded state.
3. The vascular suturing device according to claim 2, wherein the third tube body includes a first opening for the suturing needle to slide through, the first opening is located at the distal end of the third tube body, at least partially penetrates the third tube body along the radial direction of the third tube body, and the deformable member is arranged at the first opening.
4. The vascular suturing device according to claim 2, wherein the deformable member comprises a balloon, and the active member comprises a balloon catheter.
5. The vascular suturing device according to claim 3, wherein the third tube body further comprises a second opening and a third opening, the second opening being arranged on a side of the first opening away from the introduction component so that the first suturing piece can be extended out or retracted into the third tube body; the third opening and the second opening are arranged opposite to each other along the radial direction of the third tube body so that the second suturing piece can be extended out or retracted into the third tube body.
6. The vascular suturing device according to claim 1, wherein the suturing assembly further comprises a suture thread, one end of which is connected to the needle tail of the suture needle, and the other end of which is wound around the second tube body to form a preformed knot that slides on the second tube body.
7. The vascular suturing device according to claim 1, wherein the first suturing member further comprises a first rod body, the first rod body is disposed inside the first tube body and is slidably connected to the first tube body, and the distal end of the first rod body is detachably connected to the needle tail of the suturing needle.
8. The vascular suturing device according to claim 7, wherein the suturing needle further comprises a connecting piece, the connecting piece is located at the needle tail of the suturing needle and is separable from the first rod body, and the connecting piece comprises a thread hole.
9. The vascular suturing device according to claim 1, wherein the second suturing member further comprises a second rod body, the second rod body is disposed inside the second tube body and is slidably connected to the second tube body, and the distal end of the second rod body is connected to the fixing member.
10. The vascular suturing device according to claim 6, wherein the suturing assembly further includes a third operating state, in which the needle tail of the suturing needle is separated from the first tube body, the suturing needle is accommodated in the second tube body, and the suture thread passes through the preformed knot.
11. The vascular suturing device according to claim 1, wherein the vascular suturing device also includes an introduction component, the introduction component is connected to the suturing component, the introduction component includes a catheter, and a guidewire cavity is partially arranged along the axial direction of the catheter.
12. The vascular suturing device according to claim 1, wherein the vascular suturing device further comprises an operating component, wherein the operating component is respectively connected to the first suturing member and the second suturing member, and is used to control the suturing component to switch from the first operating state to the second operating state.
13. A blood vessel suturing method, wherein the blood vessel suturing device according to any one of claims 1 to 12 is used for implementation, and the blood vessel suturing method comprises:

    Controlling the first suture member and the second suture member to extend out of the anchor assembly;

    Controlling the needle tip of the suturing needle to extend out of the first tube and contact the fixing member so as to be engaged with the fixing member;

    The needle tail of the suturing needle is controlled to separate from the first tube body, the fixing member and the suturing needle are retracted into the second tube body, and the suture thread is passed through the prefabricated knot.