Blood vessel suturing instrument
By designing the vascular stapler and anchor assembly with cross-support trajectory, the complexity of suture of large-size interventional ports is solved, rapid and stable closure is achieved, and suture effect and reliability are improved.
Patent Information
- Application Number
- PCT/CN2024/105273
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2023-07-13
- Filing Date
- 2024-07-12
- Publication Date
- 2025-01-16
AI Technical Summary
The prior art When suturing large-size interventional ports, the suture process is complicated and requires multiple operations. It is difficult to achieve stable closure through suture crossing, and the blood flow rate of large-diameter blood vessels increases the difficulty of suture.
Design a vascular stapler, including an operating handle and at least two sets of suture components, each set of components consisting of a first tube body, a second tube body and a suture needle, and the track planes through which the suture needle intersects to ensure that the suture is at the interventional port. Naturally crossed, providing anchoring components and deformations for enhanced fixation.
The rapid and stable suture of large-size interventional ports is achieved, which reduces the complexity and time of the suture process, improves the suture effect and reliability, and ensures natural cross-closing of sutures.
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Figure CN2024105273_16012025_PF_FP_ABST
Abstract
Description
A vascular suture device
[0001] CROSS-REFERENCE TO RELATED APPLICATIONS
[0002] This application claims priority to Chinese patent application No. 202310856702.9, filed on July 13, 2023, entitled “A Vascular Stapler,” the entire contents of which are incorporated herein by reference. Technical Field
[0003] The present application relates to the technical field of interventional instruments, and in particular to a vascular suturing device. Background Art
[0004] Interventional therapy is a treatment method that uses puncture needles, catheters and other interventional equipment to introduce specific instruments into the diseased parts of the human body through natural channels or tiny incisions under the guidance and monitoring of imaging equipment such as angiography, CT, ultrasound and MRI for minimally invasive treatment.
[0005] Taking vascular interventional medicine as an example, after an interventional port is opened on the blood vessel, the interventional device is sent into the blood vessel through the interventional port and sent to the lesion for treatment. After the treatment is completed, the interventional device is retrieved and the interventional port is sutured. The advantage of this method is that the treatment can be completed with minimal damage.
[0006] The choice of interventional blood vessels and the size of the interventional port need to be selected according to the size of the interventional device. When the size of the interventional device is too large, it is necessary to select a large-diameter interventional blood vessel and increase the size of the interventional port, but this will increase the difficulty of suturing the interventional port.
[0007] Because blood flows faster in large-diameter access vessels, suturing requires a shorter time. Furthermore, large access ports require multiple suturing procedures, which can lead to suture threads crossing. Each suturing procedure requires the use of a guidewire, complicating the entire suturing process. Furthermore, manual adjustments to different angles can lead to suture threads crossing, among other issues. Therefore, existing technologies still need to be improved and enhanced.
[0008] Application Contents
[0009] In order to solve the problem of suturing large-sized interventional ports, the present application provides a vascular suturing device that can quickly suturing large-sized interventional ports through a single operation. The suturing process is simple, and the suture lines or their extended lines in the suture area naturally form a cross after the suturing is completed, thereby closing the large-sized interventional port.
[0010] The above-mentioned purpose of the present application is achieved through the following technical solutions. In the first aspect of the present application, a vascular suturing device is provided, comprising: an operating handle; and at least two groups of suturing assemblies, which are arranged at the distal end of the above-mentioned operating handle, wherein each group of the above-mentioned suturing assemblies comprises a first tube body, a second tube body matching the first tube body, and a suturing needle located in the first tube body; wherein the above-mentioned operating handle is configured to drive the suturing needle to extend out of the first tube body and then into the second tube body, and the above-mentioned suturing needle is separated from the above-mentioned first tube body, wherein the above-mentioned groups of suturing assemblies are arranged side by side, and among the planes where the suturing trajectories passed by the suturing needles of each group of the above-mentioned suturing assemblies are located, at least two planes intersect.
[0011] According to any of the aforementioned embodiments of the first aspect of the present application, in the vascular suturing device, the planes where the suturing trajectories of the suturing needles pass intersect and are collinear, so that after suturing, multiple suture lines can intersect at the same point in the extension direction of the vascular wall surface, making the intervention port suture more stable and reducing the risk of the intervention port cracking.
[0012] According to any of the aforementioned embodiments of the first aspect of the present application, the intersection of the planes on which the suture trajectories of the suture needles of at least two suture assemblies lie passes through the suture trajectories. Thus, after suturing, the sutures corresponding to the at least two suture assemblies naturally intersect at the insertion port, achieving stable suturing of larger insertion ports and improving the suturing effect.
[0013] According to any of the aforementioned embodiments of the first aspect of the present application, in the vascular suturing device, the number of the above-mentioned suturing components is two, and the angle formed by the planes where the suturing tracks provided by the two above-mentioned suturing needles are located is in the range of 45 degrees to 135 degrees.
[0014] According to any of the aforementioned embodiments of the first aspect of the present application, in the vascular suturing device, the planes of the suturing tracks provided by the two suturing needles are perpendicular to each other, thereby being more suitable for suturing large-sized interventional ports, while reducing the number of suturing tracks and improving the reliability of suturing.
[0015] According to any of the aforementioned embodiments of the first aspect of the present application, the suture needle includes a retracted state and a stretched state; in the retracted state, the suture needle is deformed by force and housed in the first tube body or the second tube body; in the stretched state, the suture needle at least partially extends out of the first tube body and returns to a curved shape.
[0016] According to any of the aforementioned embodiments of the first aspect of the present application, in the vascular suture device, the above-mentioned vascular suture device also includes an anchoring assembly, and the above-mentioned anchoring assembly includes a tube body, a deformable member and a driving member; the above-mentioned tube body, each group of the above-mentioned suturing assemblies is slidably arranged side by side inside the above-mentioned tube body; the above-mentioned deformable member is located at the distal end of the above-mentioned tube body, and the above-mentioned deformable member includes a contracted state and an expanded state. In the above-mentioned contracted state, the above-mentioned deformable member does not protrude from the above-mentioned tube body, and in the above-mentioned expanded state, the above-mentioned deformable member protrudes from the above-mentioned tube body and abuts against the blood vessel wall; the distal end of the above-mentioned driving member is connected to the above-mentioned deformable member, and the proximal end is connected to the operating handle or is a free end.
[0017] According to any of the aforementioned embodiments of the first aspect of the present application, in the vascular suturing device, the deformable member includes a balloon, and the driving member includes a balloon catheter.
[0018] According to any of the aforementioned embodiments of the first aspect of the present application, in the vascular suture device, the number of the above-mentioned deformable members and the above-mentioned suturing assembly are both two; wherein the angle formed by the plane where the suturing tracks provided by the two above-mentioned suturing needles are located is in the range of 45 degrees to 135 degrees, and the suturing tracks provided by the two above-mentioned suturing needles are divided into four areas, and the two above-mentioned deformable members are respectively located in two non-adjacent areas, so that the two deformable members can be used to fix the inner walls of the blood vessels on both sides of the intervention port respectively, and a better fixing effect can be obtained.
[0019] According to any of the aforementioned embodiments of the first aspect of the present application, the vascular suture device further includes: an introduction component, the proximal end of the introduction component is connected to the distal end of the tube body, a guidewire cavity is provided in the introduction component, and the guidewire cavity is connected to the tube body.
[0020] According to any of the aforementioned embodiments of the first aspect of the present application, in the vascular suturing device, an avoidance hole is provided on the tube wall of the tube body, and the above-mentioned avoidance hole is used for each suturing needle to pass through.
[0021] According to any of the aforementioned embodiments of the first aspect of the present application, in the vascular suturing instrument, the suturing assembly also includes: a release tube provided in the first tube body, and the above-mentioned suturing needle is slidably provided in the above-mentioned release tube; a pushing shaft, the proximal end of which is connected to the operating handle; and the distal end is detachably connected to the above-mentioned suturing needle; wherein the pushing shaft is configured to push the suturing needle out of the release tube, and then drive the suturing needle to extend from the release tube, bend and extend into the second tube body.
[0022] Overall, the vascular suture device provided herein utilizes at least two suturing assemblies to achieve single-shot suturing of large vascular access ports. During the suturing process, at least two suturing assemblies simultaneously puncture the vessel wall on both sides of the access port. The at least two suture lines remaining after the puncture are angled, allowing them to naturally intersect at the access port or along its extension. This suturing process requires fewer steps, is faster, and can rapidly seal large access ports. BRIEF DESCRIPTION OF THE DRAWINGS
[0023] The above and other features, advantages and aspects of the embodiments of the present disclosure will become more apparent with reference to the following detailed description in conjunction with the accompanying drawings. In the accompanying drawings, the same or similar reference numerals represent the same or similar elements, wherein:
[0024] FIG1 is a schematic diagram of the three-dimensional structure of a vascular suture device provided by the present application;
[0025] FIG2 is a schematic diagram of the structure of a portion of area A in FIG1 ;
[0026] FIG3 is a schematic diagram of a deformable member provided by the present application entering into a blood vessel;
[0027] FIG4 is a schematic diagram of suturing positions when suturing an interventional port provided by the present application, wherein the four dots in the diagram represent the positions of the suture needle when it passes through the blood vessel wall;
[0028] FIG5 is a schematic diagram of a suturing track of a suturing assembly provided by the present application, wherein the dotted line in the figure represents the suturing track;
[0029] FIG6 is a schematic structural diagram of a suturing assembly provided by the present application;
[0030] FIG7 is a schematic structural diagram of an anchoring assembly provided by the present application;
[0031] FIG8 is a schematic structural diagram of another deformable member provided by the present application;
[0032] FIG9 is a schematic diagram of a state in which the deformable member is deformed based on FIG8 ;
[0033] FIG10 is a schematic cross-sectional view of a tube provided by the present application;
[0034] FIG11 is a schematic structural diagram of another deformable member provided by the present application;
[0035] FIG12 is a schematic diagram of a state in which the deformable member is deformed based on FIG11 ;
[0036] FIG13 is a schematic structural diagram of an introduction component provided by the present application;
[0037] FIG14 is a schematic diagram of a suture needle provided by the present application passing through an avoidance hole and being reset;
[0038] FIG15 is a schematic diagram of a first receiving structure on a second tube provided by the present application;
[0039] FIG16 is a schematic diagram of a receiving tube provided by the present application having a second receiving structure;
[0040] FIG17 is a schematic diagram of a suture thread passing through a blood vessel wall at an intervention port provided by the present application;
[0041] FIG18 is a schematic diagram of a suture provided in the present application when knotting is completed.
[0042] In the various drawings, the same or corresponding reference numerals represent the same or corresponding parts; wherein the reference numerals are:
[0043] 1. Operating handle, 2. Anchoring assembly, 21. Tube body, 22. Deformable member, 221. Expandable stent, 222. Catheter, 222a. First section of catheter, 222b. Second section of catheter, 223. Pull wire, 23. Driving member, 3. Suturing assembly, 31. First tube body, 32. Second tube body, 33. Suturing needle, 34. Receiving tube, 4. Introduction assembly, 41. Catheter, 42. Guidewire cavity, 211. Avoidance hole, 35. Release tube, 36. Push shaft, 321. First receiving structure, 341. Second receiving structure, 601. Blood vessel, 602. Intervention port, 603. Guidewire channel, 604. Suture channel, 605. First tube channel, 606. Second tube channel, 607. Balloon catheter channel, 608. Calcified blood vessel, 609. Suture, 610. Suture trajectory. DETAILED DESCRIPTION
[0044] Embodiments of the present disclosure will be described in more detail below with reference to the accompanying drawings. Although certain embodiments of the present disclosure are shown in the accompanying drawings, it should be understood that the present disclosure can be implemented in various forms and should not be construed as being limited to the embodiments described herein. On the contrary, these embodiments are provided to provide a more thorough and complete understanding of the present disclosure. It should be understood that the drawings and embodiments of the present disclosure are for illustrative purposes only and are not intended to limit the scope of protection of the present disclosure.
[0045] In the description of the embodiments of the present disclosure, the term "including" and similar terms should be understood as open inclusion, i.e., "including but not limited to." The term "based on" should be understood as "based at least in part on." The term "one embodiment" or "the embodiment" should be understood as "at least one embodiment." The terms "first," "second," etc. may refer to different or the same objects. Other explicit and implicit definitions may be included below.
[0046] In addition, it should be noted that, in the description of the embodiments of this application, unless otherwise explicitly defined, "in vivo" means inside the patient's tissues and organs, and "in vitro" means outside the patient's tissues and organs. Furthermore, in the embodiments of this application, "distal" means the direction away from the physician, and "proximal" means the direction toward the physician.
[0047] In some embodiments, referring to Figures 1 to 18, the present application discloses a vascular suturing device, which is mainly composed of three parts: an operating handle 1, an anchoring assembly 2 and a suturing assembly 3. The anchoring assembly 2 is connected to the operating handle 1. As shown in Figure 2, a deformable part 22 is provided on the anchoring assembly 2, and the cross-sectional size of the deformable part 22 can be increased or decreased.
[0048] Among them, the cross-section of the deformable member 22 refers to the plane of the deformable member 22 perpendicular to the direction from the proximal end to the distal end. The cross-sectional size of the deformable member 22 can increase and decrease, which means that the deformable member 22 at least includes a contracted state and an expanded state. In the contracted state, the cross-sectional size of the deformable member 22 is relatively reduced, and in the contracted state, the cross-sectional size of the deformable member 22 is relatively increased.
[0049] Furthermore, referring to Figures 3 and 4, the function of the deformable member 22 is to abut against the inner wall of the blood vessel 601 at the access port 602, providing a foundation for subsequent suturing operations. Because when the deformable member 22 abuts against the inner wall of the blood vessel 601 at the access port 602, the deformable member 22 not only provides the operator with basic position perception, but also tightens the blood vessel walls on both sides of the access port 602, allowing the suturing assembly 3 to accurately pass through the blood vessel walls and suturing the blood vessel walls on both sides of the access port 602.
[0050] Furthermore, a channel is provided inside the anchoring assembly 2 for a guide wire to pass through. During the interventional treatment, part of the guide wire is located inside the blood vessel 601 and part is located outside the blood vessel 601. When the anchoring assembly 2 enters the blood vessel 601, the guide wire is required for guidance.
[0051] Furthermore, the guide wire located outside the blood vessel 601 first passes into the channel inside the anchoring assembly 2, and then the operator continues to push the anchoring assembly 2 toward the direction close to the blood vessel 601. During this process, the end of the anchoring assembly 2 away from the operating handle 1 will extend into the blood vessel 601 under the guidance of the guide wire.
[0052] Furthermore, when the deformable member 22 enters the blood vessel 601 through the insertion port 602 to the target position, its volume can be increased. At this time, the operator slightly pulls the operating handle 1 toward the proximal end, and the deformable member 22 will abut against the inner wall of the blood vessel 601 at the insertion port 602.
[0053] In some embodiments, there are two or more suturing assemblies 3. Among these suturing assemblies 3, the two planes on which the suturing tracks of at least two groups of suturing assemblies 3 lie intersecting, as shown in Figures 4 and 5 , which show a suturing track 610 and a suturing schematic diagram on a blood vessel 601. The suturing track refers to the path along which the suturing assembly 3 extends into the blood vessel 601 and is used to suturing the blood vessel walls on both sides of the access port 602, thereby bringing the blood vessel walls on both sides closer together.
[0054] Among them, when the number of suturing components 3 is two, the planes on which the suturing tracks of the two suturing components 3 lie intersecting. When the number of suturing components 3 is greater than two, the planes on which the suturing tracks of the respective suturing components 3 lie intersecting with each other, or further, the planes on which the suturing tracks of the respective suturing components 3 lie intersecting and collinear. It is understood that in this application, the plane on which the suturing track lies refers to the suturing track being approximately within a certain plane, and is not an absolute description. Deviations within a certain range are also within the scope of protection of this application, and this will not be elaborated on below.
[0055] It can be understood that the two planes where the suturing trajectories of at least two groups of suturing components 3 are located intersect, and the suturing trajectories of at least two groups of suturing components 3 may intersect, for example, the suturing trajectories of at least two suturing components 3 directly intersect or intersect in a spatially staggered manner, or the suturing trajectories of at least two suturing components 3 do not intersect, but in the plane where the suturing trajectories are located, the extended areas of the two suturing components outside the suturing trajectories intersect (not shown in the figure).
[0056] In some embodiments, the intersection line of the plane where the suturing trajectories of at least two groups of suturing components 3 are located passes through the above-mentioned suturing trajectories, which means that the suturing trajectories of at least two groups of suturing components 3 can directly intersect or staggeredly intersect, so that after suturing, the suture lines 609 corresponding to at least two groups of suturing components 3 can form an intersection at the insertion port 602, thereby improving the reliability of suturing.
[0057] For ease of description, the following description is made by taking as an example an example that the intersection line of the planes where the suturing tracks of at least two groups of suturing components 3 are located passes through the above suturing tracks.
[0058] In some possible implementations, the suturing track of each group of the above-mentioned suturing components 3 passes through the operating handle 1. In the present application, during the interventional treatment, it is convenient to perform positioning operations through the operating handle 1 corresponding to the intervention port 602, thereby improving the accuracy of suturing. It can be understood that the suturing track of the suturing components 3 in the present application passes through the area corresponding to the operating handle, reducing the space occupied by the entire suturing device during use. In some possible implementations, the suture line 609 after suturing each group of the above-mentioned suturing components 3 passes through the area corresponding to the operating handle 1.
[0059] In other exemplary embodiments, the number of suturing components 3 is two, and the angle formed by the planes where the suturing tracks provided by the two suturing components 3 are located is in a range of 45 degrees to 135 degrees.
[0060] In some possible implementations, the planes where the suturing tracks provided by the two suturing components 3 are located are perpendicular to each other, that is, the angle formed by the planes where the suturing tracks provided by the two suturing components 3 are located is 90 degrees.
[0061] In some embodiments, referring to Figures 2 and 6 , the suturing assembly 3 is composed of a first tube 31, a second tube 32, and a suturing needle 33. The first tube 31 and the second tube 32 are both located within the anchoring assembly 2. The first tube 31 and the second tube 32 are the same in number and are both plural. One first tube 31 and one second tube 32 are correspondingly provided to form a group.
[0062] In some possible implementations, there are two first tubes 31 and two second tubes 32 . These two groups of first tubes 31 and second tubes 32 can form an “X”-shaped suture at the insertion port 602 , as shown in FIG. 5 .
[0063] It should be noted that in some embodiments, the number of first tubes 31 can be at least two, and the at least two first tubes 31 are disposed adjacent to each other. In some embodiments, the number of second tubes 32 is the same as the number of first tubes 31, and the second tubes 32 are disposed adjacent to each other.
[0064] Furthermore, a suturing needle 33 is placed in each first tube 31. The suturing needle 33 is connected to the operating handle 1 and can be extended from the first tube 31 and extended into the second tube 32 under the drive of the operating handle 1. The operating handle 1 is also connected to the first tube 31 and the second tube 32, and can drive the first tube 31 and the second tube 32 to extend and retract from the anchor assembly 2.
[0065] It is understandable that the suture needle 33 can be directly inserted into the second tube body 32 after extending from the first tube body 31 , or it can be extended from the first tube body 31 and then pushed forward for a certain distance before being inserted into the second tube body 32 .
[0066] In some embodiments, referring to Figures 2 and 7, the anchoring assembly 2 is composed of a tubular body 21, a deformable member 22, and a driving member 23. The tubular body 21 is connected to the operating handle 1, the deformable member 22 is mounted on the tubular body 21, the first end of the driving member 23 is connected to the deformable member 22, and the second end of the driving member 23 is connected to the operating handle 1, or the second end of the driving member 23 is a free end. In this way, the operator can control the driving member 23 by operating the handle 1 or the driving member 23 to force the cross-sectional size (perpendicular to the plane of the guide wire) of the deformable member 22 to increase or decrease. Before the deformable member 22 enters the blood vessel 601 through the intervention port 602 to the target position, the deformable member 22 is accommodated in the tubular body 21 and the outer surface of the deformable member 22 does not protrude from the tubular body 21. When the deformable member 22 enters the blood vessel 601 through the intervention port 602 to the target position, its cross-sectional size can increase. At this time, the operator slightly pulls the operating handle 1 toward the proximal end, and the deformable member 22 will abut against the inner wall of the blood vessel 601 at the intervention port 602 .
[0067] Furthermore, the deformable member 22 is located at the distal end of the tube body 21 and has two states: a contracted state and an expanded state. In the contracted state, the deformable member 22 does not protrude from the tube body 21; in the expanded state, the deformable member 22 protrudes from the tube body 21 and abuts against the inner wall of the blood vessel 601.
[0068] In some alternative embodiments, the deformable member 22 and the driving member 23 have the following structural forms:
[0069] In the first embodiment, as shown in FIG7 , the deformable member 22 comprises a balloon, and the driving member 23 comprises a balloon catheter with a valve. The balloon catheter communicates with the interior of the balloon. Injecting gas or liquid (such as saline or contrast fluid) into the balloon through the balloon catheter increases the balloon's volume; expelling the gas or liquid from the balloon decreases the balloon's volume. By adjusting the balloon's volume and thus its cross-sectional dimensions, the balloon can be adapted to the different inner walls of blood vessels 601.
[0070] Furthermore, the change in the volume of the balloon will cause the cross-sectional dimensions of the balloon (in the plane perpendicular to the guidewire) to change synchronously. The first end of the balloon catheter is connected to the balloon, and the second end passes through the passage in the tube body 21 and extends from the operating handle 1 or the tube body 21 near the operating handle 1.
[0071] Furthermore, when the valve is opened, the second end of the balloon catheter changes from a closed state to an open state, and at this time, liquid can be injected into the balloon or the liquid in the balloon can be removed through the pipeline.
[0072] Furthermore, when the volume of the balloon increases and rests against the inner wall of the blood vessel 601 to be sutured, it can play a certain sealing role, reducing the amount of blood outflow from the blood vessel 601 from the sutured area, and even at this time the blood in the blood vessel 601 will not flow out from the intervention port 602.
[0073] In the second embodiment, please refer to Figure 8, the deformable member 22 is composed of an expansion bracket 221, two sections of catheters 222 and a section of traction wire 223. The two sections of catheters are respectively fixed at both ends of the expansion bracket. The difference is that the first section of catheter 222a is fixed on the outer wall of the tube body 21, and there is a gap between the second section of catheter 222b and the outer wall of the tube body 21.
[0074] In some implementations, the end of the traction wire 223 is connected to the second section of the catheter 222b, and can pull the second section of the catheter 222b closer to or away from the first section of the catheter 222a. There is a gap between the second section of the catheter 222b and the outer wall of the tube body 21 to reduce the interference between the second section of the catheter 222b and the outer wall of the tube body 21, making it easier for the traction wire 223 to pull the second section of the catheter 222b to move relative to the first section of the catheter 222a.
[0075] In some embodiments, when the second section of the catheter 222b moves toward the first section of the catheter 222a, the deformable member 22 is deformed, and the diameter of the deformable member 22 increases, that is, the diameter of the expandable stent increases, as shown in FIG9 .
[0076] In some embodiments, when the second section of the catheter 222b moves away from the first section of the catheter 222a, the diameter of the expanded stent decreases.
[0077] In some embodiments, the number of the above-mentioned deformable parts 22 and the above-mentioned suturing components 3 is two, and the two deformable parts 22 and the two suturing components 3 are alternately arranged around the axis of the tube body 21, that is, there is a suturing component 3 between the two deformable parts 22, and there is a deformable part 22 between the two suturing components 3.
[0078] In another embodiment, the number of the above-mentioned deformable members 22 and the above-mentioned suturing components 3 are both two, and the suturing components 3 are divided into four areas by the provided suturing trajectory, and the two deformable members 22 are respectively located in two non-adjacent areas. For example, at this time, there are: two first tubes 31 and two second tubes 32, and the axes of the first tubes 31 and the second tubes 32 are perpendicular to the paper. For example, the axes of the two first tubes 31 and the two second tubes 32 can be connected to form four intersecting areas, that is, the two first tubes 31 and the two second tubes 32 are divided into four areas by the provided suturing trajectory. At this time, one deformable member 22 is set in the left area of the paper adjacent to the two first tubes 31, and the other deformable member 22 is set in the right area of the paper adjacent to the two second tubes 32, that is, the two deformable members 22 are respectively located in two non-adjacent areas.
[0079] Taking the insertion port 602 as a reference, the two deformable members 22 are respectively used to fix the inner walls of the blood vessel 601 on both sides of the insertion port 602, which can achieve a better fixing effect.
[0080] Furthermore, the first end of the traction wire is connected to the second section of the catheter, and the second end is connected to the operating handle 1 after passing through the channel in the tube body 21, or the tube body 21 extends close to the operating handle 1. When the traction wire is pulled by the operating handle 1 or directly pulled, the second section of the catheter will be driven to move toward or away from the first section of the catheter.
[0081] In some embodiments, the expandable stent in the second structural form can be made of memory alloy.
[0082] In the third embodiment, please refer to Figures 11 and 12, the expansion stent in the second structure is replaced by a section of elastic catheter, and the side walls of the catheter are evenly distributed with grooves. The traction wire passes through the second section of the catheter to deform this section of the elastic catheter, and the diameter of the catheter increases at this time; when the force on the traction wire disappears, the length of this section of the elastic catheter will be restored, and the diameter of the catheter will decrease at the same time.
[0083] In some embodiments, the expandable stent in the third structural form can be cut using molecular materials or mixed with polymer materials.
[0084] Further, referring to FIG. 1 , in some embodiments, an introduction component 4 is added, and the introduction component 4 is detachably fixedly connected to the anchoring component 2 , for example, plugged in.
[0085] 13 , a guidewire cavity 42 is provided in the introduction component 4 and is communicated with the tubular body 21 . The guidewire mentioned above first enters the guidewire cavity 42 in the introduction component 4 and then enters the tubular body 21 through the guidewire cavity 42 .
[0086] Furthermore, because the introduction component 4 is elastic, it moves along the guidewire and deforms after entering the blood vessel 601 through the intervention port 602. As the contact length between the introduction component 4 and the guidewire increases, the anchoring component 2 located behind the introduction component 4 can also smoothly pass through the intervention port 602 and enter the blood vessel 601.
[0087] Furthermore, the introduction component 4 is composed of a catheter 41 , and the guidewire cavity 42 is located inside the catheter 41 .
[0088] Referring to Figure 2, in some embodiments, the tube body 21 is provided with an escape hole 211 that matches the first tube body 31. The escape hole 211 is used to guide one end of the suture needle 33 to extend into the second tube body 32. The escape hole 211 can correct or guide the movement trajectory of the suture needle 33, and its purpose is to ensure that one end of each suture needle 33 can extend into the corresponding second tube body 32 during a suturing process.
[0089] Furthermore, the suturing needle 33 includes an elastic deformable member capable of restoring a bent shape.
[0090] Specifically, the suture needle 33 includes a retracted state and a stretched state. In the retracted state, the suture needle 33 is deformed by force and accommodated in the first tube body 31 or the second tube body 32. In the stretched state, the suture needle 33 at least partially extends out of the first tube body 31 and returns to a curved shape.
[0091] In the initial state, the suture needle 33 is in the storage state, and it is housed in the first tube body 31 and deformed by force. After the suture needle 33 extends out of the first tube body 31, it is restored to the stretched state. The suture needle 33 is bent in shape, passes through the avoidance hole 211, and enters. After the suture needle 33 is housed in the second tube body 32, it is deformed by force and converted into the storage state.
[0092] During the above process, the suture needle 33 will penetrate the blood vessel wall on one side of the intervention port 602, and then pass through the blood vessel wall on the other side of the intervention port 602. When the end of the suture needle 33 passes through the blood vessel wall on the other side of the intervention port 602, it will extend into the corresponding second tube body 32.
[0093] Furthermore, the shape of the portion of the suture needle 33 located in the second tube body 32 will change again, and the curvature will decrease. At this time, the end of the suture needle 33 will be pressed against the inner wall of the second tube body 32.
[0094] Optionally, the suture thread 609 is passed through the thread hole on the suture needle 33 .
[0095] During the above process, the suture needle 33 will be moved out of the blood vessel 601 that needs to be sutured, and both ends of the suture thread 609 carried by the suture needle 33 are located outside the blood vessel 601 that needs to be sutured and are respectively located on both sides of the intervention port 602, and a part of the middle part of the suture thread 609 is located inside the blood vessel 601 that needs to be sutured.
[0096] Because there are at least two suture needles 33 , multiple suture lines 609 will appear simultaneously at the access port 602 on the blood vessel 601 during one operation, as shown in FIG. 5 .
[0097] The vascular suture device provided in each embodiment of the present disclosure is mainly used to suture large-caliber vascular wounds. Currently, such large-caliber vascular wounds are sutured multiple times. The difficulty of this suturing method is that during a complete suturing process, a portion of the suturing device needs to be delivered into the blood vessel. Each suturing will shorten the usable length of the vascular wound, that is, the subsequent suture may damage the previous suture, and there is also the risk of secondary trauma to the vascular wound. In some application scenarios, the vascular suture device provided in each embodiment of the present application can be used to suture large-caliber calcified blood vessel 608 wounds.
[0098] Furthermore, blood seepage during the suturing process can affect the operator's vision, requiring cleaning of the blood before continuing the suturing process, which obviously prolongs the suturing time. Multiple suturing of blood vessels during the suturing process can also increase the difficulty of suturing.
[0099] It should be noted that, taking the example of two sutures, after the first suture 609 is passed through the blood vessel walls on both sides of the access port 602, this suture 609 cannot be tied. Then, the second suture 609 needs to be placed. When placing the second suture 609, the position of the first suture 609 needs to be used to determine the angle of the second suture 609. This is inherently difficult because when the suturing device enters and exits the access port 602 multiple times, blood will flow out of the access port 602 and the shape of the access port 602 will also change. These actual situations require the operator to repeatedly confirm and operate multiple times.
[0100] In some possible implementations, the second tube 32 is provided with a first receiving structure 321 for securing the suture needle 33 (see FIG15 ), such as a fixing hole, so that the suture needle 33 can be retained in the second tube 32 by the first receiving structure 321. The primary function of the first receiving structure 321 is to enhance the temporary connection strength between the suture needle 33 and the second tube 32, thereby preventing the suture needle 33 from falling off the second tube 32 as it moves with the second tube 32. This is because if the suture needle 33 falls off, it is very likely to be pulled back into the blood vessel 601.
[0101] Furthermore, when part of the suture needle 33 enters the second tube body 32, its end will be pressed on the inner wall of the second tube body 32. When the end of the suture needle 33 moves to the first receiving structure 321, the end of the suture needle 33 will directly enter the first receiving structure 321. At this time, the temporary connection strength between the suture needle 33 and the second tube body 32 will increase.
[0102] Further, referring to Figures 6 and 16, the suturing assembly 3 also adds a receiving tube 34, which is arranged in the second tube body 32, and one end of the receiving tube 34 extends from the second tube body 32, and the other end is connected to the operating handle 1, and the operating handle 1 is configured to drive the receiving tube 34 to extend and retract from the second tube body 32.
[0103] Because the second tube body 32 needs to move synchronously with the first tube body 31, this means that the telescopic range of the second tube body 32 is limited, and the suture needle 33 may need to be pulled multiple times before it can be put into place due to insufficient pulling distance.
[0104] In the embodiment of the present application, after the receiving tube 34 is added, when the end of the suture needle 33 is inserted into the receiving tube 34, the suture needle 33 can be completely or mostly pulled into the second tube body 32 through the receiving tube 34. At this time, after the anchoring component 2 and the blood vessel 601 are pulled out of contact, only the suture thread 609 remains at the intervention port 602. At this time, the suture thread 609 is manually knotted and the knot is pushed to the blood vessel wall, so that the intervention port 602 can be closed.
[0105] Furthermore, referring to FIG. 16 , a second receiving structure 341 for fixing the suture needle 33 is added to the receiving tube 34 . The function of the second receiving structure 341 is the same as that of the first receiving structure 321 , and will not be described in detail here.
[0106] Referring to Figures 6 and 16, in other embodiments, the suturing assembly may further include a release tube 35 and a push shaft 36. The release tube 35 may be located within the first tubular body 31, and the suturing needle 33 may be located within the release tube 35. The suture thread 609 carried by the suturing needle 33 has one end connected to the suturing needle 33 and the other end located between the first tubular body 31 and the tubular body 21. Furthermore, the suturing needle 33 may be an elastically deformable member capable of restoring a curved shape, and the suturing needle 33 may be connected to the push shaft 36 in a detachable manner.
[0107] Furthermore, the first end of the push shaft 36 is connected to the operating handle 1, and the second end is detachably connected to the suture needle 33, for example, by adhesive bonding, tight fitting, or crimping with low connection strength. The operating handle 1 can drive the push shaft 36 to push the suture needle 33 out of the release tube 35. The suture needle 33 extends from the release tube 35, bends, and extends into the second tube body 32.
[0108] It should be noted that in some other embodiments, after the vascular suturing device reaches the target position and the anchor assembly 2 tightens the blood vessel 601, the operator pushes the push shaft 36 via the operating handle 1. At this time, the push shaft 36 pushes the suture needle 33 to gradually move out of the release tube 35. During this process, the suture needle 33 also extends from the first tube 31. After the suture needle 33 extends from the release tube 35, the restraining force on the portion of the suture needle 33 located outside the release tube 35 disappears, and this portion of the suture needle 33 begins to bend.
[0109] Here, taking the deformable member 22 as a balloon as an example, a complete suturing process is illustrated, as shown in Figures 1 to 18.
[0110] Insert one end of the guide wire into the catheter 41 , and then push the vascular suture device until the deformable member 22 passes through the intervention port 602 and enters the blood vessel 601 ;
[0111] Remove the guidewire and adjust the positions of the operating handle 1 and the anchoring assembly 2;
[0112] The volume of the deformable member 22 is adjusted by the driving member so as to increase the volume of the deformable member 22;
[0113] Slightly pull the operating handle 1 proximally to adjust the position so that the deformable member 22 rests against the inner wall of the blood vessel 601;
[0114] Push each set of first tubes 31 and second tubes 32 out of the tube body 21 , so that the first tubes 31 and second tubes 32 rest as much as possible against the outer wall of the blood vessel 601 at the insertion port 602 ;
[0115] The suture needle 33 is pushed out of the first tube body 31 by the push shaft 36. At this time, the suture needle 33 located outside the first tube body 31 switches from the storage state to the stretched state and begins to bend. The end of the bent suture needle 33 passes through the avoidance hole 211 and extends into the receiving tube 34 of the second tube body 32. After the end of the suture needle 33 enters the receiving tube 34, it is stuck in the second receiving structure 341 of the receiving tube 34.
[0116] Pull the receiving tube 34, and the receiving tube 34 drives the suture needle 33 into the second tube body 32, and the suture needle 33 switches from the stretched state to the retracted state;
[0117] The first tube body 31 and the second tube body 32 are retracted into the tube body 21. At this time, the suture 609 passes through the blood vessel walls on both sides of the intervention port 602, as shown in FIG17 ;
[0118] cutting redundant sutures 609;
[0119] draining the liquid in the deformable member 22 and removing the portion of the vascular suture device located in the blood vessel 601;
[0120] The thread ends are tied in pairs and the knots are pushed to the blood vessel wall to close the access port 602 , and the thread ends of the excess suture thread 609 are trimmed again, as shown in FIG. 18 .
[0121] In addition, in another embodiment, as shown in Figure 10, a cross-sectional schematic diagram of a tubular body 21 is shown. In this illustrated embodiment, the tubular body 21 includes a guidewire channel 603 at its center, and a suture channel 604, a first tubular body channel 605, a second tubular body channel 606, and a balloon catheter channel 607 are arranged around the central guidewire channel 603. In particular, as shown in Figure 10, it includes two suture channels 604, which are symmetrically arranged relative to the center point of the guidewire channel 603. On this basis, a line is formed with the center point of the guidewire channel 603 and the center point of the two suture channels 604, and the two balloon catheter channels 607 are symmetrically arranged relative to the line. On this basis, the line connecting the center points of the two suture channels 604 and the line connecting the center points of the two balloon catheter channels 607 intersect at the center point of the guidewire channel 603, and the plane is divided into four areas, and two first tube body channels 605 and two second tube body channels 606 are arranged in the four areas, where as shown in the figure, the two first tube body channels 605 are in the upper two plane areas, and the two second tube body channels 606 are in the lower two plane areas.
[0122] While various embodiments of the present disclosure have been described above, the foregoing description is intended to be illustrative, non-exhaustive, and not limited to the disclosed embodiments. Many modifications and variations will be apparent to those skilled in the art without departing from the scope and spirit of the described embodiments. The terminology used herein is selected to best explain the principles of the embodiments, their practical applications, or technological improvements in the marketplace, or to enable others skilled in the art to understand the embodiments disclosed herein.
[0123] The foregoing description is merely an optional embodiment of the present disclosure and is not intended to limit the present disclosure. Those skilled in the art will readily appreciate that the present disclosure is susceptible to various modifications and variations. Any modifications, equivalent substitutions, or improvements made within the spirit and principles of the present disclosure shall be included within the scope of protection of the present disclosure.
Claims
1. A vascular suture device, wherein: include: Operating handle; as well as At least two groups of suturing assemblies are arranged at the distal end of the operating handle, wherein each group of the suturing assemblies comprises a first tube body, a second tube body matching the first tube body, and a suturing needle located in the first tube body; The operating handle is configured to drive the suture needle to extend from the first tube body and then extend into the second tube body, and the suture needle is separated from the first tube body. The suturing components of each group are arranged side by side, and among the planes where the suturing tracks passed by the suturing needles of each group of suturing components are located, at least two planes intersect.
2. The vascular suture device according to claim 1, wherein: The planes where the suture tracks passed by the suture needles intersect and are collinear.
3. The vascular suture device according to claim 1, wherein: The intersection line of the planes where the suturing tracks of the suturing needles of at least two groups of the suturing assemblies are located passes through the above-mentioned suturing track.
4. The vascular suture device according to claim 1, wherein: The number of the suturing assemblies is two, and the angle formed by the planes where the suturing tracks provided by the two suturing needles are located is in the range of 45 degrees to 135 degrees.
5. The vascular suture device according to claim 4, wherein: The planes where the suturing tracks provided by the two suturing needles are located are perpendicular to each other.
6. The vascular suture device according to claim 1, wherein: The suture needle includes a stowed state and an extended state; In the storage state, the suturing needle is deformed by force and is accommodated in the first tube body or the second tube body; In the expanded state, the suture needle at least partially extends out of the first tube and returns to a bent shape.
7. The vascular suture device according to claim 1, wherein: The vascular suture device further comprises an anchoring assembly, wherein the anchoring assembly comprises a tube body, a deformable member and a driving member; The tube body, each group of the suturing components is slidably arranged side by side inside the tube body; The deformable member is located at the distal end of the 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 tube body, and in the expanded state, the deformable member protrudes from the tube body and can abut against the blood vessel wall; The distal end of the driving member is connected to the deformable member, and the proximal end is connected to the operating handle or is a free end.
8. The vascular suture device according to claim 7, wherein: The deformable member includes a balloon, and the driving member includes a balloon catheter.
9. The vascular suture device according to claim 7, wherein: The number of the deformable member and the number of the suturing assembly are both two; wherein the angle formed by the planes where the suturing tracks provided by the two suturing needles are located is in the range of 45 degrees to 135 degrees, The suturing tracks provided by the two suturing needles are divided into four areas, and the two deformable members are respectively located in two non-adjacent areas.
10. The vascular suture device according to claim 7, wherein: Also includes: An introduction component, the proximal end of which is connected to the distal end of the tube body, a guide wire cavity is provided in the introduction component, and the guide wire cavity is communicated with the tube body.
11. The vascular suture device according to claim 7, wherein: The tube wall of the tube body is provided with an avoidance hole, and the avoidance hole is used for each suture needle to pass through.
12. The vascular suture device according to claim 1, wherein: The suturing kit also includes: a release tube disposed in the first tube body, wherein the suturing needle is slidably disposed in the release tube; A push shaft, the proximal end of which is connected to the operating handle, and the distal end of which is detachably connected to the suturing needle; Wherein, the pushing shaft is configured to push the suture needle out of the release tube, thereby driving the suture needle to extend out of the release tube, bend and extend into the second tube body.
Citation Information
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