Vascular suturing device

Abstract

The application relates to the field of medical devices, in particular to a blood vessel suturing device which comprises a guide main body, an auxiliary support, a needle discharging unit and a suturing unit, the guide main body comprises a first guide part, a second connecting part and a third matching part, the diameter of the first guide part is not larger than that of the second connecting part, the auxiliary support is movably connected to the second connecting part, and the blood vessel suturing device further comprises a pulling member connected to the auxiliary support; the pulling member is pulled, the auxiliary support rotates relative to the second connecting part, and the auxiliary support is attached to a blood vessel wall; the precise needle discharging guided by the transition surface and the multi-suture line external knotting solve the problems of instability and high needle penetration failure rate in the prior art.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and more specifically to a vascular suturing device for vascular closure. Background Technology

[0002] Traditional vascular suturing relies on surgical suturing, which is complex, time-consuming, and carries a high risk of damaging the vessel wall. While some existing vascular closure devices can reduce trauma, they suffer from problems such as unstable support, suture failure due to needle exit angle deviation, and easy detachment of anchors. Therefore, there is an urgent need for a device that can precisely conform to the vessel wall, stably exit the needle, and achieve reliable suturing.

[0003] With the rapid development of interventional medical technology, Abbott's ProGlide vascular suture device has become popular in the market. However, the needle must pass through the pre-set hole of its needle foot. Since the needle needs to pass through the blood vessel wall before entering the pre-set hole, needle failure may occur, and it is impossible to verify whether the needle has turned. In addition, a special guide device is required for puncture, which requires high mechanical precision and is difficult to produce.

[0004] Patent CN202211098243.4 discloses a vascular suture device, comprising: a suture assembly, the suture assembly including a suture body, and connecting sleeves on both sides of the suture body; the connecting sleeve has a window and a baffle on its wall, the baffle extending radially inward and distally from the proximal end of the window, and a cutting portion on the outer side of the distal end of the baffle, the cutting portion being opposite to the inner wall of the connecting sleeve; a push handle assembly, with a connecting needle at the distal end of the push handle assembly, the connecting needle being capable of engaging with the connecting sleeve; and a feedback line, with a protrusion at the distal end of the feedback line disposed in the connecting sleeve, the proximal end of the feedback line extending out from the window; The connecting needle can penetrate the connecting sleeve and radially compress the baffle, causing the cutting part to embed in the window to cut the feedback line. The drawback of this solution is that: by setting a feedback line to prove that the connecting needle and the connecting sleeve are correctly engaged, the sleeve itself is small, and the window, baffle and cutting part need to be set, which is not convenient for processing. On the other hand, if the needle does not penetrate the blood vessel wall and enters the sleeve, the front or rear needle cannot be withdrawn, which means that the suture has failed.

[0005] In summary, the existing technology has the following problems that urgently need to be solved: high risk of needle insertion failure, the needle needs to accurately penetrate the blood vessel wall and enter the distal sleeve, misalignment can easily lead to suture failure; complex structure, requiring additional guiding devices, high processing precision requirements, and high cost; insufficient feedback mechanism, the needle position is verified by a feedback line, but the addition of windows, baffles and other structures increases the manufacturing difficulty, and it is difficult to retract the needle if it fails to penetrate; in addition, when encountering calcified blood vessel walls, the existing technology has limited puncture force due to complex mechanical riveting, and cannot penetrate to achieve effective suture. Summary of the Invention

[0006] This application is made in view of the above and other ideas.

[0007] One of the purposes of this application is to overcome the shortcomings of the prior art. In view of the problems of complex guiding structure and low needle insertion accuracy of the suture instrument in the prior art, a suture device that can stably support the blood vessel wall, has a large tolerance for needle insertion angle, is more conducive to needle insertion, and does not need to rely on the distal sleeve.

[0008] The objective of this invention is achieved through the following approach: A vascular suturing device includes: a guide body, an auxiliary support, a needle delivery unit, and a suturing unit. The guide body includes a first guide portion, a second connecting portion, and a third mating portion. The diameter of the first guide portion is not greater than that of the second connecting portion. The auxiliary support is movably connected to the second connecting portion and further includes a pulling member connected to the auxiliary support. Pulling the pulling member causes the auxiliary support to rotate relative to the second connecting portion, and the auxiliary support fits against the blood vessel wall. The auxiliary support includes a support body and a needle insertion area. The needle insertion area is located at both ends of the auxiliary support and has a non-closed loop shape.

[0009] The objective of this invention can also be further achieved through the following technical solutions: In one embodiment, the auxiliary support rotates to fit tightly against the blood vessel wall, preventing blood vessel displacement during suturing.

[0010] In one embodiment, the needle insertion area is U-shaped.

[0011] In one embodiment, the support body includes a rotating main body and a single-sided support portion, and the needle insertion area is shaped like a 7 or a J.

[0012] In one embodiment, the first guide portion forms a first angle with the second connecting portion in its natural state, the needle insertion area includes a first area and a second area, the area of ​​the first area is not greater than the area of ​​the second area, and the first area is located on the inclined side of the first guide portion after the auxiliary support is pulled.

[0013] In one embodiment, the guide body has a channel that begins at the distal end of the first guide portion and extends to the proximal end of the second connecting portion or the distal portion of the third mating portion.

[0014] In one implementation, after a thrombus collection procedure or other interventional procedure is performed on the blood vessel, the guide wire is still inside the blood vessel. The guide body passes through the guide wire into the blood vessel via a channel to repair the blood vessel.

[0015] In one embodiment, the support body is provided with a connecting hole, and the pulling member is connected to the connecting hole; furthermore, the connecting hole is positioned away from the center of the support body to ensure that a torque is generated when pulled, thereby achieving stable rotation.

[0016] In one embodiment, the pulling element is a flexible wire.

[0017] In one embodiment, the pull member includes a distal metal wire and a proximal flexible wire.

[0018] In one embodiment, the needle dispensing unit includes a loading tube, a needle insertion tube, and a push rod pre-installed in the needle insertion tube.

[0019] In one embodiment, the loading tube is pre-installed to fit the third mating part, the diameter of the third mating part being no greater than the diameter of the second connecting part; and it also includes a cavity that encloses the guide body and the loading tube.

[0020] In one embodiment, a transition surface is provided at the proximal end of the second connecting portion, and the needle tube exits the needle along the surface of the transition surface; and the transition surface is conical or trapezoidal.

[0021] In one embodiment, the transition surface guides the needle tube to penetrate the blood vessel wall at a preset angle, without relying on a distal sleeve.

[0022] In one embodiment, the suture unit includes an anchor and a suture thread, both pre-installed in the needle tube, and the anchor includes a deformable claw and a constraint member, the constraint member being pushed towards the distal end by the push rod.

[0023] In one embodiment, the deformable claw returns to its natural shape once it leaves the needle tube, and the free end of the deformable claw is embedded in the inner wall of the blood vessel.

[0024] In one implementation, each anchor has two, three, or four deformable claws.

[0025] In one embodiment, the suture is fixedly connected to the constraint member.

[0026] In one embodiment, both the anchor and the suture can be made of biodegradable materials.

[0027] In one embodiment, the hardness of the anchor is greater than the hardness of the suture.

[0028] In one embodiment, the suturing device includes at least two needle delivery units, and the sutures of several suturing units form a fixed knot outside the blood vessel; and the fixed knot is a fisherman's knot.

[0029] In one embodiment, the second connecting portion is connected to the auxiliary support body through the connecting hole.

[0030] In one implementation, for calcified or less elastic blood vessels, the auxiliary support disperses the support force through an asymmetrical needle insertion area to avoid damaging the blood vessel wall; the trapezoidal design of the transition surface further optimizes the needle exit angle to ensure accurate penetration of the anchor.

[0031] In one embodiment, a cutting device is also included, which cuts off excess stitching after the fixed knot is formed.

[0032] In one embodiment, the suturing device can be widely used in cardiac procedures such as coronary intervention, radiofrequency ablation, structural heart disease, and cardiopulmonary bypass.

[0033] Compared with the prior art, the advantages of the technical solution of this application include at least the following: Existing vascular suturing devices require the needle to penetrate the vessel wall before entering the designated hole, which can lead to needle failure. Furthermore, the needle cannot be retrieved or retried multiple times, placing high demands on the surgeon's skill. This application solves these problems. The auxiliary support's needle insertion area features a non-closed-loop design, offering high fault tolerance. It allows the needle to retract freely even if it hasn't fully penetrated the vessel wall, avoiding the "locking failure" caused by the needle accidentally entering the sleeve in traditional devices. Simultaneously, the distal metal wire of the pull component provides rigid transmission, while the proximal flexible wire adapts to the vessel's curvature, ensuring controllable deployment force of the auxiliary support. During surgery, tactile feedback allows the surgeon to perceive the contact state between the support and the vessel wall. The non-closed-loop needle insertion area and the force feedback characteristics of the pull component form a dual fault-tolerance mechanism, allowing the surgeon to adjust the needle depth based on feel. Combined with visual penetration confirmation from the anchor (such as ultrasound imaging), this significantly reduces the risk of secondary punctures.

[0034] Unlike existing technologies, the auxiliary support in this application has non-closed-loop puncture areas (such as U-shaped, 7-shaped, or J-shaped) at both ends of the support body. Combined with the preset angle between the first guide part and the second connecting part, when the flexible line is pulled, the auxiliary support rotates around the second connecting part. The small area of ​​the first region in the puncture area is located on the inclined side of the guide part, forming an asymmetrical support structure. Since the second connecting part and the first region form an acute angle, the first region is closer to the opening of the blood vessel, and the second region is set to be larger to accommodate blood vessels with large openings. At the same time, the connecting hole of the pulling part avoids the center of the support body, and an eccentric torque is generated when pulling, causing the auxiliary support to adhere to the inner wall of the blood vessel with a non-uniform force distribution. This is especially suitable for calcified or less elastic blood vessels, avoiding blood vessel damage caused by local stress concentration.

[0035] Unlike existing technologies, the second connecting part of this application features a conical or trapezoidal transition surface at its proximal end. The needle tube slides along this surface to exit the vessel, and the axial thrust is converted into radial puncture force through the geometric inclined surface, ensuring that the needle penetrates the vessel wall at a preset angle and avoiding needle failure due to angle deviation. Simultaneously, the anchoring element is made of biodegradable polymer material or metal material with shape memory effect. Its deformable claws (two or more) recover their natural shape after being removed from the needle tube, with the free end piercing the outer wall of the vessel. The suture has low hardness and is fixedly connected to the restraint element, forming a "hard anchoring-soft connection" structure, which ensures anchoring strength while preventing the suture from cutting the vessel tissue. In summary, the geometric design of the transition surface combined with the elastic recovery characteristics of the anchoring element's deformable claws ensures that the anchoring element unfolds immediately after the needle penetrates the vessel wall, and the multi-claw structure forms multi-point anchoring to resist blood flow impact. At the same time, the flexible characteristics of the suture combined with the fisherman's knot create a dynamic tension balance outside the vessel, preventing the knot from loosening.

[0036] Unlike existing technologies, the anchoring element and suture of this application use materials with differentiated degradation cycles, which not only meet the initial anchoring strength requirements, but also avoid long-term foreign body residue; the unilateral support part of the support body (such as 7-shaped / J-shaped) can adjust the support strategy for different vascular anatomy (such as bifurcation vessels).

[0037] Unlike existing technologies, this invention constructs a complete "support-puncture-anchoring-ligation" solution through the deep coupling of technologies such as dynamic fitting of auxiliary support components, geometric guidance of transition surfaces, multi-claw elastic recovery of anchor components, and self-tightening closure of fisherman's knots. Its core lies in replacing traditional complex guiding structures with mechanical design. Through the mechanical transmission and morphological adaptation between components, it achieves precision, minimally invasiveness, and high reliability in vascular suturing. In particular, it addresses clinical pain points such as high needle failure rates, structural redundancy, and feedback lag, demonstrating significant clinical application value.

[0038] Unlike existing technologies, the cavity of this application encloses the guide body and loading tube, maintaining the pre-loaded state and preventing component displacement during the operation; the guide body has a channel that can reuse existing guide wires and directly insert them along the interventional surgical path without additional puncture, significantly shortening the operation time; and at least two needle exit units are symmetrically arranged. After the anchor is pushed, the suture is withdrawn to the outside to weave a fisherman's knot, and the excess suture is removed by the cutting device to form a closed loop.

[0039] The embodiments of this application can achieve other advantageous technical effects not listed one by one, which may be partially described below; and these other technical effects can be expected and understood by those skilled in the art after reading this application. Attached Figure Description

[0040] The above-described features and advantages of these embodiments, as well as other features and advantages, and the ways in which they are implemented, will become more apparent from the following description in conjunction with the accompanying drawings; and embodiments of this application can be better understood, in which: Figures 1-9 This is a schematic diagram illustrating the process of the vascular suturing device of the present invention entering the blood vessel, inserting a needle, and completing the suturing.

[0041] Figure 10 and Figure 11 This is a structural schematic diagram of the auxiliary support member of the present invention and a schematic diagram showing the position of its connecting holes.

[0042] Figure 12 This is a schematic diagram of the anchoring component of the present invention pre-installed in the needle tube.

[0043] Figure 13 This is a schematic diagram of the constraint member being pushed out and the deformable claw returning to its natural state according to the present invention.

[0044] Figure 14 and 15 This is another embodiment of the auxiliary support component of the vascular suture device of the present invention.

[0045] The features represented by the numbers in the attached diagram are as follows: 1-Guide body, 11-First guide part, 12-Second connecting part, 121-Transition surface, 13-Third mating part, 2-Auxiliary support, 21-Support body, 211-Connecting hole, 212-Rotating body, 213-Single-sided support, 22-Hollowed area, 221-First area, 222-Second area, 3-Needle outlet unit, 31-Loading tube, 32-Needle insertion tube, 33-Top rod, 4-Suturing unit, 41-Anchoring part, 411-Deformable claw, 412-Constraint part, 42-Suturing thread, 5-Pull part. Detailed Implementation

[0046] The details of one or more embodiments of this application will be set forth in the following description of the accompanying drawings and specific embodiments. Other features, objects, and advantages of this application will become clear from these descriptions, drawings, and claims.

[0047] It should be understood that the phrases and terms used in this document are for descriptive purposes and should not be considered restrictive. The use of “including,” “contains,” or “has,” and their variations, in this document is intended to include, in an open-ended manner, the items listed thereafter, their equivalents, and any additional items.

[0048] The present application will now be described in more detail with reference to various embodiments and examples of several aspects thereof.

[0049] In this application, the terms "proximal" or "proximal" refer to the end or side closer to the surgeon, and "distal" or "distal" refer to the end or side farther from the surgeon. Example 1

[0050] like Figure 1 As shown, the present invention, when used for vascular closure, illustrates a vascular suturing device according to an embodiment of this application, comprising: a guide body 1, an auxiliary support 2, a needle delivery unit 3, and a suturing unit 4. The guide body 1 includes a first guide portion 11, a second connecting portion 12, and a third mating portion 13. The diameter of the first guide portion 11 is not greater than that of the second connecting portion 12. The auxiliary support 2 is movably connected to the second connecting portion 12. Furthermore, it includes a pull member 5 connected to the auxiliary support 2. Pulling the pull member 5 causes the auxiliary support 2 to rotate relative to the second connecting portion 12, and the auxiliary support 2 adheres to the vascular wall.

[0051] The objective of this invention can also be further achieved through the following technical solutions: In this first embodiment, the auxiliary support 2 includes a support body 21 and a needle insertion area 22, wherein the needle insertion area 22 is disposed at both ends of the auxiliary support 2, as shown below. Figure 10 As shown, the needle insertion area 22 is non-closed-loop in shape. The non-closed-loop design facilitates providing sufficient space for needle insertion and allows for easy retrieval of the auxiliary support 2 after the anchor 41 passes through the blood vessel wall, without causing interference.

[0052] In this first embodiment, the auxiliary support 2 rotates and fits tightly against the blood vessel wall, such as... Figure 2 As shown, this is to avoid vascular displacement during suturing.

[0053] In this first embodiment, the needle insertion area 22 is U-shaped.

[0054] In this first embodiment, the acupuncture area 22 includes a first area 221 and a second area 222, where the area of ​​the first area 221 is equal to the area of ​​the second area 222. Figure 11 As shown.

[0055] In this first embodiment, the guide body 1 is provided with a channel that starts at the distal end of the first guide part 11 and extends to the proximal end of the second connecting part 12 or the distal part of the third mating part 13.

[0056] In this first embodiment, after the blood vessel has undergone thrombus collection surgery or other interventional procedures, the guide wire is still inside the blood vessel. The guide body 1 passes through the guide wire and enters the blood vessel through the channel to repair the blood vessel.

[0057] In this first embodiment, the support body 21 is provided with a connecting hole 211, and the pulling member 5 is connected to the connecting hole 211; furthermore, the connecting hole 211 is positioned away from the center of the support body 21 to ensure that a torque is generated when pulling, thereby achieving stable rotation.

[0058] In this first embodiment, the pulling element 5 is a flexible wire.

[0059] In this first embodiment, the needle dispensing unit 3 includes a loading tube 31, a needle piercing tube 32, and a push rod 33 pre-installed in the needle piercing tube 32.

[0060] In this first embodiment, the loading tube 31 is pre-installed and fits into the third mating part 13. The diameter of the third mating part 13 is not greater than the diameter of the second connecting part 12. It also includes a cavity that encloses the guide body 1 and the loading tube 31.

[0061] In this first embodiment, a transition surface 121 is provided at the proximal end of the second connecting part 12, and the needle tube extends out along the surface of the transition surface 121; and the transition surface 121 is conical or trapezoidal.

[0062] In this first embodiment, the transition surface 121 guides the needle tube 32 to penetrate the blood vessel wall at a preset angle, without relying on the distal sleeve.

[0063] In this first embodiment, the suture unit 4 includes an anchor 41 and a suture 42, as follows: Figure 12 and 13 As shown, both are pre-installed in the needle tube 32, and the anchor 41 includes a deformable claw 411 and a constraint member 412, which moves toward the distal end by being pushed by the top rod 33.

[0064] In this embodiment, once the deformable claw 411 leaves the needle tube 32, it returns to its natural shape, and the free end of the deformable claw 411 is inserted into the inner wall of the blood vessel.

[0065] In this first embodiment, each anchor 41 has two, three, or four deformable claws 411.

[0066] In this first embodiment, the suture 42 is fixedly connected to the constraint member 412.

[0067] In this first embodiment, both the anchor 41 and the suture 42 are made of biodegradable materials.

[0068] In this first embodiment, the hardness of the anchor 41 is greater than the hardness of the suture 42.

[0069] In this first embodiment, the suturing device includes at least two needle delivery units 3, and the sutures 42 of several suturing units 4 form a fixed knot outside the blood vessel; and the fixed knot is a fisherman's knot.

[0070] In this first embodiment, the second connecting part 12 is connected to the auxiliary support body 21 through the connecting hole 211.

[0071] The exemplary operation procedure of the vascular suturing device in this embodiment is as follows: (1) Insertion device: The guide body 1 is inserted into the blood vessel through the puncture point, such as... Figure 1 The cavity shown protects the internal components; (2) Deploy the support member: Pull the pulling member 5, and the auxiliary support member 2 rotates around the second connecting part 12. Its hollow area 22 adapts to the curvature of the blood vessel and fits tightly against the inner wall, such as Figure 2 As shown; (3) Needle withdrawal and anchoring: Push the needle insertion tube 32 out of the loading tube 31 and through the blood vessel wall along the transition surface 121, as shown. Figure 3 and 4 As shown, the push rod 33 then pushes out the anchor 41, as... Figure 5 As shown, the guide body 1 is retrieved, as... Figure 6 As shown, the needle tube 32 is retrieved, as... Figure 7 As shown, the suture 42 is pulled and moved proximally, as... Figure 8 As shown; (4) External knotting: The sutures of the symmetrical needle exit units are woven into a fisherman's knot externally, and then tightened to close the puncture point, such as... Figure 9 As shown. Example 2

[0072] Example 2 is largely the same as Example 1, except that the first region 221 and the second region 222 are asymmetrically arranged, such as... Figure 14 and 15 As shown.

[0073] In this second embodiment, a vascular suturing device is introduced, including: a guide body 1, an auxiliary support 2, a needle delivery unit 3, and a suturing unit 4. The guide body 1 includes a first guide part 11, a second connecting part 12, and a third mating part 13. The diameter of the first guide part 11 is not greater than that of the second connecting part 12. The auxiliary support 2 is movably connected to the second connecting part 12. Furthermore, it also includes a puller 5 connected to the auxiliary support 2. Pulling the puller 5 causes the auxiliary support 2 to rotate relative to the second connecting part 12, and the auxiliary support 2 fits against the blood vessel wall.

[0074] In this second embodiment, the support body 21 includes a rotating main body 212 and a single-sided support part 213, and the needle insertion area 22 is 7-shaped or J-shaped.

[0075] In this second embodiment, the first guide part 11 forms a first angle with the second connecting part 12 in its natural state. The needle insertion area 22 includes a first area 221 and a second area 222. The area of ​​the first area 221 is not greater than the area of ​​the second area 222. After the auxiliary support 2 is pulled, the first area 221 is located on the inclined side of the first guide part 11.

[0076] In this first embodiment, the pulling member 5 includes a distal metal wire and a proximal flexible wire.

[0077] In this regard, the relevant construction and concept of Embodiment 2 are similar to those of Embodiment 1, and therefore will not be described again here.

[0078] The foregoing description of several embodiments of this application has been provided for illustrative purposes. This foregoing description is not intended to be exhaustive, nor is it intended to limit the application to the precise configurations, constructions, and / or steps disclosed; obviously, many modifications and variations can be made in light of the teachings above. The scope of the invention and all its equivalents are intended to be defined by the appended claims.

Claims

1. A vascular suture device, characterized in that, include: The system comprises a guide body, an auxiliary support, a needle insertion unit, and a suturing unit. The guide body includes a first guide portion, a second connecting portion, and a third mating portion. The diameter of the first guide portion is not greater than that of the second connecting portion. The auxiliary support is movably connected to the second connecting portion and also includes a pulling member connected to the auxiliary support. Pulling the pulling member causes the auxiliary support to rotate relative to the second connecting portion, and the auxiliary support fits against the blood vessel wall. The auxiliary support includes a support body and a needle insertion area. The needle insertion area is located at both ends of the auxiliary support and has a non-closed-loop shape.

2. The vascular suture device according to claim 1, characterized in that, In its natural state, the first guide portion forms a first angle with the second connecting portion. The needle insertion area includes a first area and a second area. The area of ​​the first area is not greater than the area of ​​the second area. When the auxiliary support is pulled, the first area is located on the inclined side of the first guide portion.

3. The vascular suture device according to claim 1 or 2, characterized in that, The support body is provided with a connecting hole, and the pulling member is connected to the connecting hole; and the connecting hole is located away from the center of the support body.

4. The vascular suture device according to claim 1, characterized in that, The needle dispensing unit includes a loading tube, a needle insertion tube, and a top rod pre-installed in the needle insertion tube.

5. The vascular suture device according to claim 4, characterized in that, The loading tube is pre-installed to fit the third mating part, the diameter of the third mating part being no greater than the diameter of the second connecting part; and it also includes a cavity, in which the third mating part and the loading tube are pre-installed.

6. The vascular suture device according to claim 4 or 5, characterized in that, The proximal end of the second connecting part is provided with a transition surface, and the needle tube exits the needle along the surface of the transition surface; and the transition surface is conical or trapezoidal.

7. The vascular suture device according to claim 4, characterized in that, The suture unit includes an anchor and a suture thread, both of which are pre-installed in the needle tube. The anchor includes a deformable claw and a constraint member, which moves toward the distal end under the push of the top rod.

8. The vascular suture device according to claim 4, characterized in that, The suturing device includes at least two needle delivery units, and the sutures of several suturing units form a fixed knot outside the blood vessel; and the fixed knot is a fisherman's knot.

9. The vascular suture device according to claim 4, characterized in that, The second connecting part is connected to the auxiliary support body through the connecting hole.

10. The vascular suturing device according to claim 1, characterized in that... The support body includes a rotating main body and a single-sided support part, and the needle insertion area is 7-shaped or J-shaped.

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