A vascular suturing device with a suturing unit

Abstract

The application relates to the field of medical devices, in particular to a blood vessel suturing device with a suturing unit, which comprises a guide main body, a pricking needle unit and a suturing unit. The suturing unit comprises an anchor and a suture connected with the anchor, the suturing unit is preassembled in the pricking needle unit, the pricking needle unit comprises a curved section arranged at a distal end and a straight section connected with the curved section, the free end of the curved section first moves towards the distal end and then bends to pass through the blood vessel tissue in the proximal direction, and after implantation, the suturing unit forms at least three fixed points with the surface of the blood vessel tissue, the anchoring effect is good, and the tension can be self-adaptively adjusted.

Description

Technical Field

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

[0002] Traditional vascular suturing relies on surgical suturing, which is complex, time-consuming, and carries a high risk of damage to the vessel wall. In interventional vascular procedures (such as cardiac interventions and peripheral vascular interventions), postoperative closure of the puncture site is a critical step. Traditional methods rely on manual suturing or pressure hemostasis, which is complex, time-consuming, and highly invasive. Existing suturing devices often use a single suture path or anchor point, which can easily lead to insecure closure or tissue tearing. Furthermore, existing devices are difficult to adapt to different vessel thicknesses and tortuosities, requiring multiple punctures and increasing the risk of complications. Therefore, there is an urgent need for a novel vascular suturing device that can provide multi-point fixation, is easy to operate, and is highly adaptable.

[0003] Patent CN202410250388.4 discloses a vascular suture device, including a suture device body, suture bases, insert needles, suture, lead wire, drive mechanism, and target tube. The target tube is located at one end of the suture device body, and at least three suture bases are provided on the target tube. The drive mechanism is located within the target tube and the suture device body, and is used to control the opening or retraction of the suture bases. A winding hole is provided on the target tube, and the lead wire is installed in the winding hole. The connector of the lead wire is engaged with several of the suture bases. At least three insert needles are located inside the suture device body, and the suture is located inside the suture device body, with the connector of the suture engaging with the tip of the insert needle. The insert needle can drive the connector of the suture to engage with the connector of the lead wire. The drawback of this solution is that suturing requires three suture bases, and the more suture bases there are, the more likely needle insertion failure will occur. Furthermore, if the needle does not penetrate the vessel wall and enters the sleeve, the front or rear needle cannot be retracted, meaning the suturing has failed.

[0004] 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; the suture has only two connection points with the tissue, which can easily cause tissue tearing. Summary of the Invention

[0005] This application is made in view of the above and other ideas.

[0006] One of the purposes of this application is to overcome the shortcomings of the prior art and to provide a vascular suturing device with a suturing unit, addressing the problems of cumbersome operation, insecure closure, and poor adaptability of existing suturing instruments.

[0007] The objective of this invention is achieved through the following solution: A vascular suturing device with a suturing unit includes: a guide body, a needle insertion unit, and a suturing unit. The suturing unit includes an anchor and a suture connected thereto. The suturing unit is pre-installed within the needle insertion unit. The needle insertion unit includes a curved section disposed at a distal end and a straight section connected to the curved section. The free end of the curved section first moves distally and then bends to pass through the vascular tissue proximally. Furthermore, after implantation, the suturing unit forms at least three fixation points with the surface of the vascular tissue.

[0008] The objective of this invention can also be further achieved through the following technical solutions: In one embodiment, the anchoring member includes a constraint member and a plurality of deformable members fixedly connected to the constraint member, the free ends of the deformable members being inserted into vascular tissue.

[0009] In one embodiment, one end of the deformable member is a free end, and the other end is fixedly connected to the constraint member.

[0010] In one implementation, the curved segments of the two needle units are punctured symmetrically.

[0011] In another embodiment, the curved sections of the two needle units are punctured at an intersecting angle.

[0012] In one embodiment, the suturing device includes at least two needle insertion units, and the curvature of the curved section exceeds 180 degrees.

[0013] In one embodiment, the curved segment is set with a preset angle.

[0014] In one embodiment, the curvature of the curved section is freely controlled by a handle.

[0015] In another embodiment, the suturing device includes three needle insertion units and three suturing units.

[0016] In one embodiment, the sutures of the suture unit converge at one point to form a fixed knot.

[0017] In one embodiment, a curved segment punctures the vascular tissue twice, and after each of the two puncture units passes through the vascular tissue, the puncture unit forms four connection points with the surface of the vascular tissue.

[0018] In one embodiment, after the needle unit is retrieved, the anchor is located at the two connection points on the outside, and the two connection points in the middle converge at one place after the suture is pulled, while the blood vessel opening closes.

[0019] In another embodiment, a curved segment passes through the blood vessel opening and enters the blood vessel wall. After the two needle insertion units each pass through the blood vessel tissue, the needle insertion units form two connection points with the blood vessel tissue.

[0020] In another embodiment, after the needle insertion unit is retrieved, the two sutures are located at the blood vessel opening. Pulling the suture causes the anchors on both sides to move towards the center, closing the blood vessel opening.

[0021] In one embodiment, the needle insertion unit is pre-installed in a loading tube, and a push rod is also pre-installed in the needle insertion unit for pushing the suture unit toward the distal end.

[0022] In one embodiment, the push rod is pushed after the puncture action of the needle unit is completed.

[0023] In one embodiment, after the anchor is pushed out by the push rod, the suture can be pulled to retract the anchor into the needle insertion unit.

[0024] In one embodiment, the suture forms a fixation knot outside the blood vessel; and the fixation knot is a fisherman's knot.

[0025] In one embodiment, after the suture unit is implanted, both the fixation knot and the anchor are located outside the blood vessel.

[0026] In one embodiment, the guiding body includes a first guiding part, a second guiding part, and a third guiding part.

[0027] In one embodiment, the first guide section, the second guide section, and the third guide section are arranged sequentially from the distal end to the proximal end.

[0028] In one embodiment, the guide body has an internal channel that originates at the distal end of the first guide portion.

[0029] In one embodiment, the diameter of the second guide portion is larger than the diameter of the first guide portion, and the diameter of the second guide portion is also larger than the diameter of the third guide portion.

[0030] In one embodiment, the guide body and the loading tube are located in a cavity.

[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 reused, placing high demands on the surgeon's skill. Additionally, for large-diameter vascular suturing, multiple puncture points and repeated punctures are necessary, requiring an additional set of suturing instruments, reducing surgical efficiency and increasing the patient's financial burden. This application solves these problems by employing a "distal extension followed by reverse puncture" path in the curved segment. A single puncture can form a U-shaped or circular trajectory, replacing the traditional multiple punctures. It eliminates the need to locate specific puncture points. The U-shaped or circular trajectory ensures a certain distance between the two puncture points in a curved segment, which can be adjusted according to the required suture diameter, adapting to different puncture diameters and guaranteeing a high success rate. Furthermore, the multi-point mechanical distribution design prevents tissue tearing and ensures a more secure closure.

[0034] Unlike existing technologies, the anchoring element of this application has multiple deformable parts (such as barbs or hook-like structures) that penetrate into the vascular tissue to form a dispersed anchoring. When the suture is pulled, the middle connection point converges towards the center, and the outer anchoring element restricts displacement, forming a "three-point stable structure". The tensile strength is increased by more than 2 times. At the same time, when the blood vessel pulsates or the external pressure changes, the multi-point design can adaptively adjust the tension to avoid the failure of a single anchoring point.

[0035] Unlike existing technologies, all anchoring elements (such as metal or polymer materials) and suture fixation knots (fisherman's knots) in this application are located on the outer wall of the blood vessel, with zero foreign body residue in the blood vessel and the risk of thrombosis approaching zero; moreover, the self-locking properties of the fisherman's knot far exceed clinical requirements, avoiding secondary intervention.

[0036] Unlike existing technologies, the curved segment uses a super-elastic nickel-titanium alloy, which can automatically adjust the puncture angle according to the curvature of the blood vessel. The curved segments of the two needle units are punctured at symmetrical or cross angles. Figure 4 It covers a 270° circumferential range of the blood vessel, ensuring uniform closure.

[0037] Unlike existing technologies, the anchoring component of this application is made of biodegradable polymer material or metal material with shape memory effect. Its deformable part is claw-shaped and returns to its natural shape after being removed from the needle tube. The free end pierces into the blood vessel wall, while the suture has low hardness and is fixedly connected with the restraint component to form a "hard anchoring-soft connection" structure, which ensures anchoring strength and avoids the suture cutting the blood vessel tissue.

[0038] Unlike existing technologies, this application is simple to operate. The suture unit (including anchors and sutures) is pre-installed in the needle insertion unit. The push rod is pushed to release it. After the needle insertion unit completes the puncture, it automatically retracts, leaving only the sutures and anchors.

[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 1-4 This is a schematic diagram showing the vascular suturing device of the present invention entering a blood vessel and performing needle insertion.

[0041] Figures 5-7 This is a schematic diagram illustrating the suturing process of the vascular suturing device of the present invention.

[0042] Figure 8 This is a schematic diagram of the anchoring element of the present invention pre-installed in the needle insertion unit.

[0043] Figure 9 This is a schematic diagram of the constraint member being pushed out and the deformed member returning to its natural claw shape.

[0044] Figure 10 and 11 This is another embodiment of the vascular suturing device of the present invention.

[0045] The features represented by the numbers in the attached diagram are as follows: 1-Guiding body, 11-First guiding part, 12-Second guiding part, 13-Third guiding part, 2-Needling unit, 21-Bent section, 22-Straight section, 3-Suturing unit, 31-Anchoring component, 311-Deformable component, 312-Constraint component, 32-Suture line, 321-Fixing knot, 4-Loading tube, 5-Top rod. 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 and Figure 4 As shown, the present invention, when used for vascular closure, illustrates a vascular suturing device with a suturing unit 3 according to an embodiment of this application, comprising: a guide body 1, a needle insertion unit 2, and a suturing unit 3. The suturing unit 3 includes an anchor 31 and a suture 32 connected thereto. The suturing unit 3 is pre-installed within the needle insertion unit 2. The needle insertion unit 2 includes a curved section 21 disposed at a distal end and a straight section 22 connected to the curved section 21. The free end of the curved section 21 first moves distally and then bends to pass through the vascular tissue proximally. Furthermore, after implantation, the suturing unit 3 forms at least three fixation points with the surface of the vascular tissue, such as... Figure 7 As shown.

[0051] The objective of this invention can also be further achieved through the following technical solutions: In this first embodiment, the anchoring member 31 includes a constraint member 312 and a plurality of deformable members 311 fixedly connected to the constraint member 312. The free ends of the deformable members 311 are at least partially embedded in vascular tissue, such as... Figure 8 and Figure 9 As shown.

[0052] In this first embodiment, one end of the deformable member 311 is a free end, and the other end is fixedly connected to the constraint member 312.

[0053] In this first embodiment, the curved segments 21 of the two needle-piercing units 2 are punctured symmetrically, such as... Figure 2 and Figure 3 As shown.

[0054] In this embodiment, the suturing device includes two needle-piercing units 2, and the curvature of the curved section 21 exceeds 180 degrees.

[0055] In this first embodiment, the curved segment 21 is set with a preset angle.

[0056] In this first embodiment, the sutures 32 of the suture unit 3 converge at one point to form a fixed knot 321, such as... Figure 7 As shown.

[0057] In this first embodiment, a curved segment 21 punctures the vascular tissue twice. After the two puncture units 2 pass through the vascular tissue, the puncture unit 2 forms four connection points with the surface of the vascular tissue.

[0058] In this first embodiment, the blood vessel wall has four puncture holes, such as Figure 6 As shown.

[0059] In this first embodiment, after the needle unit 2 is retrieved, the anchor 31 is located at the two connection points on the outside, and the two connection points in the middle converge at one place after the suture 32 is pulled, and the blood vessel opening closes at the same time.

[0060] In this first embodiment, the needle insertion unit 2 is pre-installed in the loading tube 4, and the needle insertion unit 2 is also pre-installed with a push rod 5, which is used to push the suture unit 3 to move toward the distal end.

[0061] In this first embodiment, after the puncture action of the needle unit 2 is completed, the push rod 5 is pushed.

[0062] In this embodiment, after the anchor 31 is pushed out by the top rod 5, the suture piece can be pulled to retract the anchor 31 into the needle insertion unit 2.

[0063] In this first embodiment, the suture 32 forms a fixing knot 321 outside the blood vessel; and the fixing knot 321 is a fisherman's knot.

[0064] In this first embodiment, after the suture unit 3 is implanted, both the fixation knot 321 and the anchor 31 are located outside the blood vessel.

[0065] In this first embodiment, the guiding body 1 includes a first guiding part 11, a second guiding part 12, and a third guiding part 13.

[0066] In this first embodiment, the first guide part 11, the second guide part 12 and the third guide part 13 are arranged sequentially from the far end to the near end.

[0067] In this first embodiment, the guide body 1 has a channel inside, which starts from the far end of the first guide part 11.

[0068] In this first embodiment, the diameter of the second guide part 12 is larger than the diameter of the first guide part 11, and the diameter of the second guide part 12 is also larger than the diameter of the third guide part 13.

[0069] In this first embodiment, during pre-installation, the loading tube 4 is attached to the third guide part 13, and the distal end of the loading tube 4 does not contact the second guide part 12.

[0070] In this first embodiment, the guide body 1 and the loading tube 4 are located in the same cavity.

[0071] In this first embodiment, a cutting device is also included. After the fixed knot 321 is formed, the cutting device cuts off the excess stitching 32.

[0072] 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 As shown; (2) Needle dispensing: Pushing the needle insertion unit 2, as shown Figure 2 As shown, each curved segment 21 passes through the vascular tissue twice, as... Figure 3 As shown; (3) Anchoring: Push the top rod 5 to push out the anchoring member 31, as shown. Figure 4 As shown, the needle insertion unit 2 is retrieved, as... Figure 5 As shown, when the suture 32 is pulled towards the proximal end, the opening gradually decreases, as... Figure 6 As shown; (4) External knotting: The suture 32 is woven into a fisherman's knot externally, and then tightened to close the puncture point, such as Figure 7 As shown. Example 2

[0073] Example 2 is largely the same as Example 1, except that a curved segment 21 passes through the opening of the blood vessel and enters the blood vessel wall, and each curved segment 21 punctures the blood vessel tissue only once.

[0074] In this second embodiment, as Figure 10 and 11 As shown, a vascular suturing device with a suturing unit 3 is introduced, comprising: a guide body 1, a needle insertion unit 2, and a suturing unit 3. The suturing unit 3 includes an anchor 31 and a suture 32 connected thereto. The suturing unit 3 is pre-installed in the needle insertion unit 2. The needle insertion unit 2 includes a curved section 21 disposed at the distal end and a straight section 22 connected to the curved section 21. The free end of the curved section 21 first moves distally and then bends to pass through the vascular tissue in a proximal direction. Furthermore, after implantation, the suturing unit 3 forms at least three fixation points with the surface of the vascular tissue.

[0075] In this second embodiment, a curved segment 21 passes through the blood vessel opening and enters the blood vessel wall. After the two needle insertion units 2 pass through the blood vessel tissue, the needle insertion unit 2 and the blood vessel tissue form two connection points.

[0076] In this second embodiment, after the needle insertion unit 2 is retrieved, the two sutures are located at the blood vessel opening. Pulling the suture 32 causes the anchors 31 on both sides to move towards the center, closing the blood vessel opening.

[0077] In this second embodiment, there are two puncture sites on the blood vessel wall.

[0078] In this second embodiment, the vascular suturing device is used to suture large-diameter vascular openings.

[0079] In this second embodiment, the curvature of the curved section 21 is freely controlled by the handle.

[0080] In this second embodiment, after the curved section 21 enters the blood vessel, the handle can be operated to make the entire needle insertion unit 2 move axially.

[0081] 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.

[0082] 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 suturing device with a suturing unit, characterized in that, include: The device comprises a guide body, a needle insertion unit, and a suture unit. The suture unit includes an anchor and a suture connected thereto. The suture unit is pre-installed within the needle insertion unit. The needle insertion unit includes a curved section located at the distal end and a straight section connected to the curved section. The free end of the curved section first moves distally and then bends to pass through the vascular tissue proximally. Furthermore, after implantation, the suture unit forms at least three fixation points with the surface of the vascular tissue.

2. The vascular suture device according to claim 1, characterized in that, The anchoring element includes a constraint element and several deformable elements fixedly connected to the constraint element, with the free ends of the deformable elements inserted into the vascular tissue.

3. The vascular suture device according to claim 1, characterized in that, The suturing device includes at least two needle insertion units, and the curvature of the curved section exceeds 180 degrees.

4. The vascular suture device according to claim 1, characterized in that, A curved segment punctures the vascular tissue twice. After each of the two puncture units passes through the vascular tissue, the puncture unit forms four connection points with the surface of the vascular tissue.

5. The vascular suture device according to claim 4, characterized in that, After the needle unit is retrieved, the anchor is located at the two connection points on the outside, and the two connection points in the middle converge at one place after the suture is pulled, and the blood vessel opening closes at the same time.

6. The vascular suture device according to claim 1, characterized in that, A curved segment passes through the opening of the blood vessel and enters the blood vessel wall. After the two needle insertion units each pass through the blood vessel tissue, the needle insertion units and the blood vessel tissue form two connection points.

7. The vascular suture device according to claim 6, characterized in that, After the needle insertion unit is retrieved, the two suture pieces are located at the blood vessel opening. Pulling the suture line causes the anchors on both sides to move towards the center, closing the blood vessel opening.

8. The vascular suture device according to claim 1, characterized in that, The needle insertion unit is pre-installed in the loading tube, and the needle insertion unit is also pre-installed with a push rod, which is used to push the suture unit to move distally.

9. The vascular suture device according to claim 1, characterized in that, The suture forms a fixation knot outside the blood vessel; and the fixation knot is a fisherman's knot.

10. The vascular suture device according to claim 1, characterized in that, After the suture unit is implanted, both the fixation knot and the anchor are located outside the blood vessel.

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