A minimally invasive vessel suturing device

Abstract

The application relates to the technical field of medical devices, and particularly discloses a minimally invasive blood vessel suturing device. In order to solve the problem that the outer diameter of a conventional suturing device entering a blood vessel is relatively large, a'second expansion' is caused to the blood vessel wall, and tissue damage is aggravated, the device comprises a holding part, a sheath pipe, a fixed end head, a suturing rod, a deformation assembly and a driving mechanism, one end of the sheath pipe is fixedly connected with the holding part; the fixed end head is fixed in the inner cavity of the end of the sheath pipe away from the holding part; the suturing rod is fixedly connected with the end of the fixed end head away from the sheath pipe and extends out of the sheath pipe, the diameter of the suturing rod is smaller than that of the fixed end head, and the outer diameter of the part of the suturing rod entering the blood vessel is not greater than 7 French; the deformation assembly is arranged on the suturing rod and is used for unfolding and abutting against the inner wall of the blood vessel after the suturing rod is inserted into the blood vessel; and the driving mechanism is arranged in the holding part and is used for driving the deformation assembly to unfold or fold. The application can reduce the secondary damage to the blood vessel puncture port.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to a minimally invasive vascular suture device. Background Technology

[0002] In modern interventional procedures such as transcatheter aortic valve replacement (TAVR) and endovascular repair of the great arteries, large-diameter (typically 18-30 Fr) access devices need to be established in major blood vessels such as the femoral artery. After the procedure, the safe, effective, and rapid closure of these large-diameter puncture sites is crucial to preventing postoperative complications such as bleeding, hematoma, and pseudoaneurysm.

[0003] Currently, commonly used methods for vascular closure in clinical practice mainly include manual compression, vascular occluders, and vascular suture devices. Manual compression is time-consuming, has a poor patient experience, and carries a high risk of failure for patients with large-diameter puncture sites or those receiving anticoagulation therapy. Vascular occluders (such as collagen plugs) are passive closure methods, which have inherent drawbacks such as foreign body residue, embolism, and limited closure strength.

[0004] Vascular suture devices can actively suture the vessel wall, theoretically achieving more physiological healing. However, to achieve anchoring and suturing functions, existing suture devices typically require the integration of a drive mechanism and suture into the vessel's entry point, resulting in a relatively large outer diameter (generally greater than 8 Fr). When passing through existing puncture channels, this causes "secondary dilation" of the vessel wall, exacerbating tissue damage, increasing the risk of postoperative bleeding, and partially offsetting the benefits of minimally invasive surgery. Summary of the Invention

[0005] To reduce secondary damage to the vascular puncture site, this application provides a minimally invasive vascular suture device.

[0006] The minimally invasive vascular suture device provided in this application adopts the following technical solution:

[0007] A minimally invasive vascular suture device, comprising:

[0008] Holding part;

[0009] A sheath, one end of which is fixedly connected to the gripping part;

[0010] A fixed end is fixed in the inner cavity of the sheath at the end away from the gripping part;

[0011] A suture rod is fixedly connected to the fixed end away from the sheath and extends outside the sheath. The diameter of the suture rod is smaller than the diameter of the fixed end, and the outer diameter of the portion of the suture rod entering the blood vessel is no greater than 7 French.

[0012] A deformable component, disposed on the suture rod, is configured to unfold and abut against the inner wall of the blood vessel after the suture rod is inserted into the blood vessel; and...

[0013] A drive mechanism, disposed within the gripping portion, is used to drive the deformation component to expand or retract.

[0014] Furthermore, the deformation component includes:

[0015] Both the first and second rings can be slidably fitted onto the suture rod, with the first ring located between the fixed end and the second ring;

[0016] At least two symmetrically arranged anchoring element groups; each anchoring element group includes a first anchoring plate and a second anchoring plate whose ends are hinged to each other, the end of the first anchoring plate away from the second anchoring plate is hinged to the first collar, and the end of the second anchoring plate away from the first anchoring plate is hinged to the second collar.

[0017] The driving mechanism is used to drive the second ring to move along the axial direction of the stitching rod, so that each anchoring component group can be expanded or retracted synchronously.

[0018] Furthermore, the drive mechanism includes:

[0019] A control handle assembly is disposed within the grip portion;

[0020] The push rod is slidably disposed within the sheath.

[0021] A plurality of tie members, one end of which is connected to the second collar and the other end of which passes through the fixed end and is connected to the distal end of the push rod;

[0022] The control handle assembly is connected to the proximal end of the push rod and is used to drive the push rod to reciprocate, thereby pulling or pushing the second collar to move through the tie member.

[0023] Furthermore, it also includes a pre-installed suture system, the system comprising:

[0024] At least two sutures are pre-placed on the suture bar; and,

[0025] A lead-out mechanism for leading out the suture and passing it through vascular tissue;

[0026] The lead-out mechanism includes a plurality of suture needles and a plurality of thread terminals of equal number. The thread terminals are used to fix the end of the suture and are releasably disposed on the suture bar, and correspond one-to-one with the suture needles.

[0027] Each of the suture needles is configured to move toward and lock onto its corresponding thread terminal so that when the suture needle is pulled back, the corresponding thread terminal and the fixed suture are pulled out from the suture bar.

[0028] Furthermore, the wire terminal is a tubular structure with at least one elastic plate on its inner wall, the elastic plate being inclined toward the interior of the tubular structure;

[0029] The distal end of the suture needle is constructed in a triangular pyramid shape;

[0030] When the distal end of the suture needle is inserted into the corresponding wire terminal, the elastic plate is stretched open and slides over the triangular cone, and rebounds at the root of the triangular cone to form a one-way locking structure that prevents the suture needle from coming out.

[0031] Furthermore, the number of sutures is two, and the number of suture terminals and suture needles is four each;

[0032] The suture rod has two suture slots, and each suture slot contains a folded suture thread;

[0033] The stitching rod has four corresponding assembly slots, and each assembly slot is provided with a wire terminal.

[0034] The suture rod has a thread hole that communicates with the thread placement groove;

[0035] The two ends of the suture thread pass through the corresponding thread holes and enter the two adjacent assembly slots, and are fixedly connected to the wire terminals provided in the assembly slots.

[0036] Furthermore, it also includes a guide assembly, which includes a guide seat fixed to the outer peripheral wall of the distal end of the sheath tube. The guide seat is provided with a plurality of curved guide tubes, which are arranged around the peripheral wall of the sheath tube and correspond one-to-one with the position of the assembly groove.

[0037] The opening direction of the proximal end of each guide tube is toward the sheath axis, and the opening direction of the distal end of each guide tube is toward the corresponding assembly groove.

[0038] The suture needle exits from the sheath wall and extends into the proximal opening of the guide tube. The suture needle passes through the guide tube and is guided to pierce the corresponding assembly groove.

[0039] Furthermore, the outer diameter of the suture rod used to enter the blood vessel portion is 6French.

[0040] Furthermore, the control handle assembly includes:

[0041] A drive handle is rotatably mounted on the grip portion;

[0042] A drive rod, one end of which is connected to the rotation shaft of the drive handle;

[0043] The sliding box is connected to the other end of the drive rod and is constrained by the positioning structure to slide only along the axial direction of the gripping part;

[0044] A sliding block is slidably disposed within the sliding box;

[0045] The positioning rod is fixedly inserted into the sliding block;

[0046] An elastic element is sleeved on the positioning rod, with one end of the elastic element abutting against the sliding block and the other end of the elastic element abutting against the inner wall of the sliding box.

[0047] The proximal end of the push rod is fixedly connected to the sliding block. Rotating the drive handle can drive the sliding box to move, and the sliding box can push or pull the sliding block and the push rod to move synchronously.

[0048] Furthermore, the grip portion is also provided with a control component, which includes a push handle connected to the proximal end of the suture needle. The push handle is movably disposed along the axial direction of the grip portion and is used to independently control the firing and retraction of the suture needle.

[0049] In summary, this application includes at least one of the following beneficial technical effects:

[0050] 1. The instrument's gripping part guides the connected sheath and the suture rod at its tip percutaneously into the blood vessel along the guidewire. Because the suture rod's diameter is smaller than the fixed end and its outer diameter is no greater than 7 French inches, it can pass slenderly through the vascular puncture site, reducing secondary damage to the puncture site. After entering the blood vessel, the operator operates the drive mechanism within the gripping part, which unfolds the deformation component on the suture rod, bringing it against the inner wall of the blood vessel, thus providing stable internal anchoring for subsequent operations. After the operation is completed, the drive mechanism allows the deformation component to retract, facilitating the safe withdrawal of the instrument. Integrating the deformation component onto a significantly reduced-diameter, independent suture rod, rather than within a large sheath, ensures miniaturization of the instrument's entry point into the blood vessel from the design stage, laying a structural foundation for minimizing secondary dilation and physical damage to the vascular puncture site.

[0051] 2. During the suturing phase, the surgeon moves the suture needle toward the target. The needle pierces and connects to the suture terminal pre-embedded within the suture rod. Then, when the needle is pulled back, the locked suture terminal and one end of the fixed suture are pulled out of the suture rod, thus completing the crucial step of the suture passing through the vascular tissue. This revolutionizes the suturing process, simplifying it significantly and greatly enhancing its reliability. It eliminates the traditionally high-risk and difficult procedures of grasping and threading sutures within unseen vascular cavities, making suture extraction more certain and reliable, and greatly improving the success rate of the surgery.

[0052] 3. After the suture needle exits the sheath wall, it immediately enters a curved guide tube. This guide tube, like a pre-set track, forcibly deflects the needle tip path, changing its movement from axial along the sheath to radial movement precisely aimed at the corresponding mounting groove on the suture rod. This solves the ultimate problem of precise puncture and docking in the confined space of the body, ensuring that regardless of the surgeon's technique, the landing point of each suture is pre-set and symmetrical. This not only greatly improves the success rate of the operation but also makes the distribution of suture points more compact and regular, achieving "precise minimally invasive surgery".

[0053] 4. The outer diameter of the working end of the suture rod can be as low as 6 French. When used in conjunction with the pre-embedded suture technique, it almost does not cause secondary dilation of the vascular puncture site. From a physical perspective, it minimizes the risk of vascular damage and postoperative bleeding caused by the instrument itself, achieving the ultimate in minimally invasive surgery.

[0054] 5. When the drive mechanism is working, it drives the second ring to move axially along the suture rod. If the second ring is pulled closer to the first ring, it forces the first and second anchoring pieces to rotate around their hinged ends, causing each anchoring assembly to unfold outward from its closed state until its outer surface adheres to the inner wall of the blood vessel; conversely, when the second ring is pushed away from the first ring, the anchoring assembly retracts back to the surface of the suture rod.

[0055] 6. Two sutures are pre-embedded, with each suture connected to two adjacent terminals at both ends. Four needles are aligned with the four terminals. Through four symmetrical needle exit points, the surgeon can flexibly choose to perform double-line cross suture or double-line parallel suture. Only one instrument can cover most clinical closure needs, achieving multi-functionality and firm closure. Attached Figure Description

[0056] To more clearly illustrate the technical solutions in the embodiments of this application or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0057] Figure 1 This is a schematic diagram showing the overall structure of the suture device according to an embodiment of this application;

[0058] Figure 2 This is an exploded view of the gripping part according to an embodiment of this application;

[0059] Figure 3 This is a schematic diagram showing the structure of the anchor assembly retracting onto the stitching rod in an embodiment of this application;

[0060] Figure 4 This is an enlarged structural diagram of the fixed end shown in an embodiment of this application;

[0061] Figure 5 This is an enlarged structural schematic diagram showing the unfolded anchor assembly according to an embodiment of this application;

[0062] Figure 6 This is a schematic diagram showing the connection structure between the push rod and the tie member in an embodiment of this application;

[0063] Figure 7 This is a schematic diagram showing the connection structure of the positioning rod, the suture needle, and the push rod in an embodiment of this application;

[0064] Figure 8 This is a schematic diagram showing the structure of the suture needle inserted into the assembly groove according to an embodiment of this application;

[0065] Figure 9 This is a schematic diagram showing the mating structure of the suture needle and the wire terminal in an embodiment of this application;

[0066] Figure 10 This is a schematic diagram illustrating the structure of the suture rod entering the blood vessel, as shown in an embodiment of this application.

[0067] Figure 11 This is a schematic diagram illustrating the structure of the deformable component changing from a contracted to an expanded state within a blood vessel, according to an embodiment of this application.

[0068] Figure 12 This is a schematic diagram illustrating the structure of the present application embodiment showing how pressing and pushing the handle drives the sewing needle into the corresponding assembly slot;

[0069] Figure 13 This is an enlarged cross-sectional view of the insertion of a suture needle into the assembly groove, as shown in an embodiment of this application.

[0070] Explanation of reference numerals in the attached drawings: 1. Grip; 11. Top shell; 12. Bottom shell; 13. Limiting plate; 2. Sheath; 3. Fixed end; 31. Relief groove; 4. Stitching rod; 41. Thread placement groove; 42. Assembly groove; 43. Thread hole; 5. Deformation assembly; 51. First collar; 52. Second collar; 53. Anchoring assembly; 531. First anchoring piece; 532. Second anchoring piece; 6. Drive mechanism; 61. Control handle assembly; 611. Drive handle; 6 12. Drive rod; 613. Sliding box; 614. Sliding block; 615. Positioning rod; 6151. Slide groove; 6152. Passage groove; 616. Elastic element; 62. Push rod; 63. Tie element; 7. Pre-placed suture system; 71. Suture thread; 72. Lead-out mechanism; 721. Suture needle; 722. Thread terminal; 723. Elastic plate; 8. Guide assembly; 81. Guide seat; 82. Guide tube; 9. Control assembly; 91. Push handle. Detailed Implementation

[0071] To make the objectives, technical solutions, and advantages of the embodiments of this application clearer, the technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only a part of the embodiments of this application, not all of them. Therefore, the detailed description of the embodiments of this application provided in the accompanying drawings is not intended to limit the scope of the claimed application, but merely to represent selected embodiments of this application. All other embodiments obtained by those skilled in the art based on the embodiments of this application without inventive effort are within the scope of protection of this application.

[0072] It should be noted that in the field of interventional medical devices, the end of the medical device that is closer to the clinician inside the body is generally called the proximal end, and the end that is farther from the clinician is called the distal end. Based on this principle, the proximal and distal ends of any part of the interventional device are defined. The axial direction generally refers to the length of the medical device, and the radial direction generally refers to the direction perpendicular to the axial direction.

[0073] The following combination Figures 1 to 13 This application will be described in further detail.

[0074] This application discloses a minimally invasive vascular suture device, referring to... Figures 1 to 9 It includes a gripping part 1, a sheath 2, a fixed end 3, a suture rod 4, a deformation assembly 5, a drive mechanism 6, and a pre-placed suture system 7.

[0075] Reference Figure 1 and Figure 2 The grip 1 is an ergonomically designed handle shell, composed of a top shell 11 and a bottom shell 12, and houses the drive mechanism 6 inside. (See reference...) Figure 3 and Figure 4 The sheath 2 is a slender, rigid or semi-rigid hollow tube. The proximal end of the sheath 2 is fixedly connected to the gripping part 1, and the fixing end 3 is fixed in the lumen of the distal end of the sheath 2. The proximal end of the suture rod 4 is fixedly connected to the fixing end 3 and extends distally out of the sheath 2. The diameter of the suture rod 4 is significantly smaller than that of the fixing end 3. The outer diameter of the portion of the suture rod 4 entering the blood vessel is no greater than 7 French. In this embodiment, the outer diameter of the portion of the suture rod 4 entering the blood vessel is 6 French. The secondary expansion generated by the suture rod 4 with an outer diameter of 6 French when passing through the puncture site is almost negligible, minimizing the risk of vascular wall damage and postoperative bleeding caused by the passage of the instrument itself.

[0076] Reference Figure 4 The outer wall of the fixed end 3 is provided with several clearance grooves 31. The bottom surface of the clearance grooves 31 is flush with the outer wall of the sewing rod 4, which is used to provide a smooth passage for the tie piece 63 and the like.

[0077] Reference Figure 3 and Figure 5 The deformation assembly 5 includes a first collar 51, a second collar 52, and two symmetrically arranged anchoring member groups 53. The first collar 51 and the second collar 52 are slidably fitted onto the stitching rod 4, with the first collar 51 close to the fixed end 3. Each anchoring member group 53 consists of a first anchoring piece 531 and a second anchoring piece 532. The ends of the first anchoring piece 531 and the second anchoring piece 532 are hinged to each other via a hinge shaft. The end of the first anchoring piece 531 away from the second anchoring piece 532 is hinged to the first collar 51, and the end of the second anchoring piece 532 away from the first anchoring piece 531 is hinged to the second collar 52.

[0078] Reference Figure 3 and Figure 5 The drive mechanism 6 controls the deformation assembly 5. The drive mechanism 6 includes a control handle assembly 61 disposed within the grip portion 1, a push rod 62 slidably disposed within the sheath tube 2, and a plurality of tie members 63. In this embodiment, the number of tie members 63 is four, and they are equidistantly spaced around the periphery of the stitching rod 4. In other embodiments, the number of tie members 63 can be any number greater than two. (Refer to...) Figure 6 The tie member 63 is a slender flexible metal strip. One end of the tie member 63 is connected to the second ring 52, and the other end of the tie member 63 passes through the relief groove 31 on the fixed end 3 and then converges and connects to the far end of the push rod 62.

[0079] Reference Figure 2 and Figure 7The control handle assembly 61 includes a drive handle 611, a drive rod 612, a sliding box 613, a sliding block 614, a positioning rod 615, and an elastic element 616. Two parallel limiting plates 13 are provided on both the top shell 11 and the bottom shell 12. The limiting plates 13 are arranged along the axial direction of the grip portion 1. The sliding box 613 is located between the two limiting plates 13, and the limiting plates 13 restrict the sliding box 613 from moving along the axial direction of the grip portion 1. The sliding block 614 is located in the inner cavity of the sliding box 613, and the two opposite side walls of the sliding block 614 abut against the two side walls of the limiting box. The positioning rod 615 passes through the sliding block 614 and is fixedly connected to it. Through holes are provided at both ends of the sliding box 613 for the positioning rod 615 to pass through. In this embodiment, the elastic element 616 is a spring. The elastic element 616 is sleeved on the positioning rod 615, with one end abutting against the sliding block 614 and the other end abutting against the inner wall of the sliding box 613. The rotating shaft of the drive handle 611 is rotatably disposed within the gripping part 1. One end of the drive rod 612 is connected to the rotating shaft of the drive handle 611, and the other end of the drive rod 612 is fixedly connected to the sliding box 613. A groove 6151 is provided on the outer wall of the positioning rod 615 for the push rod 62 to slide. The end of the push rod 62 away from the tie member 63 extends into the gripping part 1 and passes through the groove 6151, where it is fixed to the sliding block 614.

[0080] During operation, rotating the drive handle 611 causes the sliding box 613 to move axially along the grip part 1 via the drive rod 612. The sliding box 613 pushes or pulls the sliding block 614 via the elastic element 616. The sliding block 614 drives the push rod 62 and the tie element 63 to move, ultimately driving the second ring 52 to move closer to or away from the first ring 51, thereby controlling the unfolding and retraction of the anchoring assembly 53. The elastic element 616 plays a crucial buffering role. When the anchoring piece is fully attached to the blood vessel wall, if the handle is continued to be rotated, the elastic element 616 is compressed, which can prevent the transmission of excessive mechanical force from damaging the blood vessel intima.

[0081] Reference Figure 4 and Figure 8 The outer wall of the suture rod 4 has two suture grooves 41 along the axial direction. The outer peripheral wall of the suture rod 4 has four assembly grooves 42 evenly distributed. Each pair of assembly grooves 42 forms a group. The two groups of assembly grooves 42 are located at different points on the axis of the suture rod 4. The two suture grooves 41 are located between the assembly grooves 42 in each group. The suture rod 4 also has a suture hole 43 that communicates with the suture grooves 41.

[0082] Reference Figure 8 and Figure 9The pre-installed suture system 7 includes two sutures 71 and an extraction mechanism 72 for leading the sutures 71 out and through vascular tissue. The extraction mechanism 72 includes four wire terminals 722. The two sutures 71 are folded in half and housed in two suture slots 41, and the four wire terminals 722 are placed in four assembly slots 42. The two ends of each suture 71 pass through a suture hole 43 inside the suture rod 4, enter two adjacent assembly slots 42, and are securely fixed to the corresponding wire terminal 722 by knotting, gluing, or crimping. The wire terminal 722 is made of a thin metal tube by laser cutting. In this embodiment, the tube wall of the wire terminal 722 has two symmetrically arranged through holes, and an elastic plate 723 inclined towards the center of the tube is connected to the inner wall of the through holes. In other embodiments, the number of elastic plates 723 can be different.

[0083] Reference Figure 8 and Figure 9 The lead-out mechanism 72 also includes the same number of suture needles 721 as the wire terminals 722. The distal end of the suture needle 721 is machined into a triangular cone shape, and a locking shoulder is formed behind the cone. When the triangular cone-shaped distal end of the suture needle 721 is inserted into the corresponding wire terminal 722, the elastic plate 723 is stretched open and slides over the triangular cone. The elastic plate 723 abuts against the locking shoulder, forming a one-way locking structure to prevent the suture needle 721 from coming out. Thus, when the suture needle 721 is withdrawn, the wire terminal 722 and the suture 71 can be pulled out of the assembly groove 42 together.

[0084] Reference Figure 3 and Figure 4 To ensure that the suture needle 721 can accurately and repeatedly puncture and lock the wire terminal 722, four guide seats 81 are fixed to the outer periphery of the distal end of the sheath 2. Each guide seat 81 has a pre-formed curved guide tube 82 embedded in it, and each guide tube 82 corresponds to the position of the mounting groove 42. The proximal inlet of each guide tube 82 faces the axis of the sheath 2 and is inserted into the sheath 2 to receive the suture needle 721 that passes through the side wall of the sheath 2. The opening of the distal end of each guide tube 82 faces the center of the corresponding mounting groove 42.

[0085] Reference Figure 1 and Figure 2The grip 1 also includes a control component 9, which controls the firing and retraction of each suture needle 721. The control component 9 includes a push handle 91 connected to the proximal end of the four suture needles 721. One end of the push handle 91 inside the grip 1 is positioned between two limiting plates 13, thereby limiting the movement direction of the push handle 91 towards the axial direction of the grip 1. The outer wall of the positioning rod 615 also has four passage slots 6152 for the suture needles 721 to pass through. One end of the four suture needles 721 enters the grip 1 from the suture rod 4 and passes through the passage slots 6152 to be fixedly connected to one end of the push handle 91. The other end of the push handle 91 exits from the end of the grip 1 away from the sheath 2, facilitating operation by medical personnel.

[0086] The implementation principle of a minimally invasive vascular suture device according to an embodiment of this application is as follows: After completing the interventional procedure and removing the large sheath 2, the guidewire is retained. The sheath 2 and suture rod 4 of this suture device are inserted along the guidewire until the deformation component 5 is completely inserted into the vascular lumen, and the fixed end 3 is placed against the outside of the vascular puncture site (e.g., Figure 10 (As shown). At this time, the instrument is in its initial state, with both the deformation component 5 and the suture needle 721 in the retracted state. Rotate the drive handle 611 on the grip 1 clockwise (as shown). Figure 10 (As shown). The drive mechanism 6 smoothly pulls the second ring 52 towards the first ring 51 via the tie member 63, forcing the two anchoring assemblies 53 to unfold outwards synchronously. The outer arc surface of the first anchoring piece 531 fits against the inner wall of the blood vessel over a large area, forming a stable internal support and reliably anchoring the device in the blood vessel (as shown). Figure 11 (As shown).

[0087] Applying a pushing force to the push handle 91, the suture needle 721 is pushed out of the side wall of the sheath 2 and enters the curved guide tube 82. Under the precise guidance and constraint of the guide tube 82, the path of the suture needle 721 is deflected, accurately piercing the blood vessel wall, and finally inserted into the corresponding mounting groove 42 on the suture rod 4 (e.g., Figure 12 and Figure 13 (As shown). The triangular cone-shaped front end of the suture needle 721 opens the elastic plate 723 inside the wire terminal 722 and inserts it completely. When the root of the cone passes the elastic plate 723, the elastic plate 723 quickly rebounds and locks behind the locking shoulder, forming a firm one-way lock.

[0088] Pulling the push handle 91 backward causes the suture needle 721 to retract. Since the needle end is locked, the pull action pulls the suture terminal 722 out of the assembly slot 42, and one end of the suture 71 fixed thereto is pulled out, passing through the blood vessel wall tissue, and finally retracts with the suture needle 721 to the vicinity of the external puncture point.

[0089] Turn the drive handle 611 counterclockwise to retract the deformation component 5, making it completely conform to the outer wall of the suture rod 4. Gently withdraw the entire suture device along the guide wire. At this point, all four ends of the two sutures 71 are outside the body. Depending on the puncture site, the surgeon can pull the sutures and choose to perform a cross-stitch or double-thread parallel suture placement, tying a knot inside the puncture tract or subcutaneously. After cutting the sutures, a secure and aesthetically pleasing closure of the vascular puncture site is achieved.

[0090] The above description is merely a preferred embodiment of this application and is not intended to limit this application. Various modifications and variations can be made to this application by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this application should be included within the protection scope of this application.

Claims

1. A minimally invasive vascular suture device, characterized in that, include: Holding part (1); Sheath (2), one end of which is fixedly connected to the grip (1); Fixed end (3), the fixed end (3) is fixed in the inner cavity of the sheath (2) away from the grip (1); The suture rod (4) is fixedly connected to the end of the fixed end (3) away from the sheath (2) and extends outside the sheath (2). The diameter of the suture rod (4) is smaller than the diameter of the fixed end (3). A deformable component (5), disposed on the suture rod (4), is used to unfold and abut against the inner wall of the blood vessel after the suture rod (4) is inserted into the blood vessel; and, A drive mechanism (6) is disposed within the gripping part (1) and is used to drive the deformation component (5) to unfold or retract. The deformation component (5) includes: The first ring (51) and the second ring (52) can be slidably sleeved on the suture rod (4), and the first ring (51) is located between the fixed end (3) and the second ring (52); At least two symmetrically arranged anchoring element groups (53); each anchoring element group (53) includes a first anchoring piece (531) and a second anchoring piece (532) with their ends hinged together, the end of the first anchoring piece (531) away from the second anchoring piece (532) being hinged to the first collar (51), and the end of the second anchoring piece (532) away from the first anchoring piece (531) being hinged to the second collar (52); The driving mechanism (6) is used to drive the second ring (52) to move axially along the stitching rod (4), so that each anchoring assembly (53) can be opened or closed synchronously. It also includes a pre-installed suture system (7), the system comprising: At least two sutures (71) are pre-placed on the suture bar (4); and, A lead-out mechanism (72) is used to lead out the suture (71) and pass it through the vascular tissue; The lead-out mechanism (72) includes a plurality of suture needles (721) of equal number and a plurality of thread terminals (722). The thread terminals (722) are used to fix the end of the suture (71) and are releasably disposed on the suture bar (4), and correspond one-to-one with the suture needles (721). Each of the suture needles (721) is configured to move toward and lock onto its corresponding thread terminal (722) so that when the suture needle (721) is pulled back, the corresponding thread terminal (722) and the fixed suture thread (71) are pulled out from the suture bar (4). The suture rod (4) has an outer diameter of 6French for entering the blood vessel portion.

2. The minimally invasive vascular suture device according to claim 1, characterized in that, The drive mechanism (6) includes: A control handle assembly (61) is disposed within the grip portion (1); The push rod (62) is slidably disposed inside the sheath (2); A plurality of tie members (63), one end of which is connected to the second collar (52) and the other end passes through the fixed end (3) and is connected to the far end of the push rod (62); The control handle assembly (61) is connected to the proximal end of the push rod (62) to drive the push rod (62) to reciprocate, thereby pulling or pushing the second collar (52) to move through the tie member (63).

3. The minimally invasive vascular suture device according to claim 1, characterized in that, The wire terminal (722) is a tubular structure, and its inner wall is provided with at least one elastic plate (723), the elastic plate (723) being inclined toward the interior of the tubular structure; The distal end of the suture needle (721) is constructed in a triangular pyramid shape; When the distal end of the triangular cone of the suture needle (721) is inserted into the corresponding wire terminal (722), the elastic plate (723) is stretched open and slides over the triangular cone, and rebounds at the root of the triangular cone to form a one-way locking structure that prevents the suture needle (721) from coming out.

4. The minimally invasive vascular suture device according to claim 1, characterized in that, The number of sutures (71) is two, and the number of suture terminals (722) and suture needles (721) is four each; The suture rod (4) has two suture grooves (41), and each suture groove (41) contains a folded suture thread (71). The stitching rod (4) is provided with four mounting slots (42), and each mounting slot (42) is provided with a wire terminal (722). The suture rod (4) has a suture hole (43) that communicates with the suture groove (41). The two ends of the suture (71) pass through the corresponding wire holes (43) and enter the two adjacent assembly slots (42), and are fixedly connected to the wire terminals (722) provided in the assembly slots (42).

5. A minimally invasive vascular suture device according to claim 4, characterized in that, It also includes a guide assembly (8), which includes a guide seat (81) fixed to the outer peripheral wall of the distal end of the sheath (2). The guide seat (81) is provided with a plurality of curved guide tubes (82), which are arranged around the peripheral wall of the sheath (2) and correspond one-to-one with the position of the assembly groove (42). The proximal opening of each guide tube (82) faces the axis of the sheath tube (2), and the distal opening of each guide tube (82) faces the corresponding mounting groove (42). The suture needle (721) passes through the wall of the sheath (2) and extends into the proximal opening of the guide tube (82). The suture needle (721) passes through the guide tube (82) and is guided to pierce the corresponding assembly groove (42).

6. A minimally invasive vascular suture device according to claim 2, characterized in that, The control handle assembly (61) includes: A drive handle (611) is rotatably mounted on the grip (1); A drive rod (612), one end of which is connected to the rotation shaft of the drive handle (611); The sliding box (613) is connected to the other end of the drive rod (612) and is constrained by the positioning structure to slide only along the axial direction of the grip (1); A sliding block (614) is slidably disposed within the sliding box (613); The positioning rod (615) is fixedly inserted through the sliding block (614). An elastic element (616) is sleeved on the positioning rod (615). One end of the elastic element (616) abuts against the sliding block (614), and the other end of the elastic element (616) abuts against the inner wall of the sliding box (613). The proximal end of the push rod (62) is fixedly connected to the sliding block (614). Rotating the drive handle (611) can drive the sliding box (613) to move, and the sliding box (613) can push or pull the sliding block (614) and the push rod (62) to move synchronously.

7. The minimally invasive vascular suture device according to claim 1, characterized in that, The grip (1) is also provided with a control component (9), which includes a push handle (91) connected to the proximal end of the suture needle (721). The push handle (91) is movably disposed along the axial direction of the grip (1) and is used to independently control the firing and retraction of the suture needle (721).

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