A suturing device

Abstract

The application relates to a suturing device, which comprises a delivery tube and a puncture assembly, a first channel is formed in the delivery tube, the first channel extends along the axial direction of the delivery tube, the proximal end of the first channel penetrates the proximal end of the delivery tube, a puncture port is arranged on the side wall of the distal end of the delivery tube, and the puncture port communicates with the distal end of the first channel; the first channel comprises a first channel and a second channel which are connected with each other, the proximal end of the first channel penetrates the proximal end of the delivery tube, and the axis of the first channel is parallel to the axis of the delivery tube; the second channel gradually inclines radially outward from the proximal end to the distal end, and the distal end of the second channel communicates with the puncture port; the puncture assembly is arranged in the first channel, and the distal end of the puncture needle can penetrate out of the puncture port. The surgical difficulty can be reduced, the closure effect on the oval foramen can be improved, and the probability of complications can be reduced.

Description

Technical Field

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

[0002] Patent foramen ovale (PFO) is a congenital heart defect where the foramen ovale between the left and right atria fails to close completely during early childhood development, resulting in an abnormal passageway between the two atria. PFO is present in one-quarter of the general population and is a common congenital heart abnormality. PFO has been linked to various diseases, including cryptogenic stroke and migraine. Therefore, treating PFO is crucial for preventing these diseases.

[0003] Currently, the main treatment for patent foramen ovale (PFO) is to implant an occluder through interventional procedures to close the PFO. With the development of technology, some methods also use interventional suturing to close the PFO. However, existing PFO suturing devices all use multiple sutures tied at a single point to suture the PFO. For example, CN117426818A discloses a suturing device for interventional treatment. After multiple puncture pieces pass through the interatrial septum, the sutures are captured by the capture part on the back. After the capture part is retrieved, the sutures are tightened to close the PFO.

[0004] In the above scheme, multiple puncture devices are set in the suturing device at the same time, which makes the radial dimension of the delivery tube larger, thereby increasing the difficulty of the operation. In addition, the current method is not only complicated to operate, but also difficult to completely close the foramen ovale, resulting in residual shunting, or even causing tissue damage or new complications. Summary of the Invention

[0005] In view of this, the present invention proposes a suturing device that can reduce the difficulty of surgery, improve the sealing effect on the foramen ovale, and reduce the probability of complications.

[0006] The technical solution adopted in this invention:

[0007] A suturing device includes a delivery tube and a puncture assembly. A first channel is formed inside the delivery tube and extends axially along the delivery tube. The proximal end of the first channel penetrates the proximal end of the delivery tube. A puncture port is provided on the side wall of the distal end of the delivery tube and communicates with the distal end of the first channel.

[0008] The first channel includes a first channel and a second channel that are connected to each other. The proximal end of the first channel extends through the proximal end of the delivery tube, and the axis of the first channel is parallel to the axis of the delivery tube. From proximal to distal, the second channel gradually tilts radially outward, and the distal end of the second channel connects to the puncture site.

[0009] The puncture assembly includes a puncture needle and a suture structure. The suture structure includes a suture and at least three anchors. In the extension direction of the puncture needle, these anchors are sequentially inserted at the distal end of the puncture needle. In the length direction of the anchors, a first through hole and a second through hole are sequentially provided. The first through hole is located on the proximal side of the second through hole. From proximal to distal, these anchors are connected in series by the suture. In any two adjacent anchors, the one on the proximal side is the first anchor and the one on the distal side is the second anchor. The suture passes through the first through hole of the first anchor, the second through hole of the first anchor, the first through hole of the second anchor, and the second through hole of the second anchor.

[0010] The puncture assembly is inserted through the first channel, and the distal end of the puncture needle can exit through the puncture port.

[0011] Preferably, the puncture needle has a puncture channel formed along its axial direction, the puncture channel has a circular cross-section, and the side wall of the puncture needle is also provided with a relief groove. In the radial direction, the relief groove communicates with the puncture channel. The relief groove is located at the distal end of the puncture needle, and the distal end of the relief groove penetrates the distal end of the puncture needle. The width of the relief groove is smaller than the inner diameter of the puncture channel.

[0012] The anchoring member includes a columnar mating part and a plate-shaped limiting part. The limiting part is connected to the outer peripheral surface of the mating part, and the length direction of the limiting part is consistent with the length direction of the mating part. The thickness of the limiting part matches the width of the clearance groove. The mating part mates with the puncture channel, and the limiting part extends out of the clearance groove. The first through hole and the second through hole are located on the limiting part and are located outside the puncture needle.

[0013] Preferably, the distal end of the mating part is provided with a first cut, so that the distal end of the mating part forms a first inclined surface, and from far to near, the first inclined surface is inclined toward the side away from the limiting part; the distal end of the limiting part is provided with a second cut, so that the distal end of the limiting part forms a second inclined surface, and from far to near, the second inclined surface is inclined toward the side away from the mating part, and the first inclined surface and the second inclined surface together constitute a cone.

[0014] Preferably, the puncture needle includes a first part and a second part connected to each other, the length of the second part being equal to the length of the clearance groove, and the clearance groove being located in the second part.

[0015] The inner wall of the second part is provided with a plurality of impact protrusions. Along the length direction of the second part, the plurality of impact protrusions are equally spaced. The number of impact protrusions is A, and the number of anchors is B, BA=1. When all the anchors are located in the second part, B anchors and A impact protrusions are staggered. Each pair of adjacent anchors is separated by an impact protrusion.

[0016] The impact protrusion has a stop portion facing distally to prevent the anchor from moving proximally along the puncture needle.

[0017] Preferably, in the second part, a U-shaped slit is formed on the side wall of the puncture needle, and the impact protrusion is formed within the U-shaped slit. The opening of the U-shape constitutes the root of the impact protrusion. On the impact protrusion, the end corresponding to the root is the free end of the impact protrusion. In the radial direction of the second part, the impact protrusion bends inward around its root, so that the free end of the impact protrusion is located within the puncture channel. On the impact protrusion, its root is located on the proximal side of its free end. A guide slope is formed on the inner surface of the impact protrusion, and the guide slope is radially inclined inward from near to far. The free end of the impact protrusion constitutes the stop portion.

[0018] As the anchor slides along the second portion toward the distal end, the anchor can press the impact protrusion outward along the guide ramp, flattening the impact protrusion and allowing the anchor to pass over the impact protrusion in one direction.

[0019] Preferably, it also includes a push rod, which passes through the puncture channel to push the anchor from the proximal side to the distal side.

[0020] Preferably, the delivery pipe is further provided with a strip-shaped auxiliary groove, the auxiliary groove extends along the axial direction of the delivery pipe, the distal end of the auxiliary groove is connected to the puncture port, and the radially inner side of the auxiliary groove extends to the first channel; the clearance groove is directly connected to the auxiliary groove, and the portion of the limiting part that extends out of the clearance groove passes through the auxiliary groove.

[0021] Preferably, a second channel is also formed inside the conveying pipe, the second channel extends along the axial direction of the conveying pipe and passes through both ends of the conveying pipe respectively, and the first channel and the second channel are not connected to each other;

[0022] The suturing device also includes a guide wire structure that passes through the second channel.

[0023] Preferably, the guide wire structure includes a guide wire body and a support member connected to the distal end of the guide wire body. The support member is made of nickel-titanium alloy wire. In its natural state, the support member is triangular. The distal end of the guide wire body is connected to one corner of the support member, and the plane of the support member is perpendicular to the extension direction of the distal end of the guide wire body.

[0024] The guide wire structure has a first state and a second state relative to the delivery tube.

[0025] In the first state, the support member is strip-shaped and is housed within the distal end of the second channel;

[0026] The guide wire structure is delivered to the distal end, causing the support member to extend beyond the distal end of the second channel, thereby switching the guide wire structure from the first state to the second state.

[0027] In the second state, the support member unfolds into a triangle, with the far end of the second channel pointing towards the center of the triangular support member.

[0028] Preferably, the number of the first channels is two or three, and these first channels are arranged at equal angles around the axis of the conveying pipe along the axial direction of the conveying pipe, and the inclination angles of the second channels of these first channels are different.

[0029] Each of the first channels corresponds to one of the puncture components;

[0030] The number of the support members is the same as the number of the first channels. These support members are evenly arranged around the distal end of the guide wire body. The size of these support members is different. In the second state, the second channels point one-to-one to the center of the triangular support members. The smaller the inclination angle of the second channel, the smaller the size of the corresponding support member.

[0031] The beneficial effects of this invention are:

[0032] The first frame has one first channel formed in the delivery tube. The puncture component is set through the first channel, which means there is also only one puncture component. Therefore, the radial dimension of the delivery tube can be controlled to be small, which facilitates the delivery of the delivery tube in the artery, facilitates the operation, and improves the safety of interventional surgery.

[0033] When closing the foramen ovale using this invention, the distal end of the delivery tube passes through the foramen ovale on the interatrial septum. At this time, the puncture assembly does not pass through the foramen ovale. Keeping the delivery tube stationary, the puncture needle is pushed distally. Due to the outward tilt of the second channel, the distal end (tip) of the puncture needle exits from the puncture site along the second channel. The tip of the puncture needle gradually moves distally and radially outward, causing the puncture needle to gradually move away from the foramen ovale radially. Therefore, the tip of the puncture needle will contact the interatrial septum surrounding the foramen ovale and puncture the interatrial septum. The puncture needle, carrying one of the distal anchors, passes through the interatrial septum. Then, the puncture needle is withdrawn proximally. The distal end of the puncture needle... Returning to the other side, as the puncture needle is withdrawn, the most distal anchor is left on the other side of the interatrial septum. The delivery tube rotates at a certain angle, causing the puncture needle to rotate at the same angle. The above actions are then repeated to implant the second anchor into the other side of the interatrial septum, so that these anchors are evenly distributed around the periphery of the foramen ovale on the other side of the interatrial septum. Since these anchors are connected by sutures, a single suture is used to suture a circle around the periphery of the foramen ovale. Then the suture is tightened, making the diameter of the circle formed by the suture smaller, thereby gradually reducing the size of the internal foramen ovale until it is closed.

[0034] The suturing device of the present invention enables a single suture to be sutured around the periphery of the foramen ovale. Therefore, when the suture is tightened, the tightening force of the suture around the periphery is basically the same, thereby causing the size of the foramen ovale to shrink proportionally. This avoids the situation in the prior art where multiple sutures have inconsistent tightening forces, resulting in poor local shrinkage of the foramen ovale. This ensures that the foramen ovale can be effectively closed, improving the surgical outcome. Attached Figure Description

[0035] The above and other objects, features and advantages of the present invention will become clearer from the following description of embodiments of the invention with reference to the accompanying drawings, in which:

[0036] Figure 1 This is a schematic diagram of the suturing device;

[0037] Figure 2 This is a cross-sectional view of the delivery pipe;

[0038] Figure 3 This is a schematic diagram of the conveying pipe structure;

[0039] Figure 4 This is a cross-sectional view of the puncture needle;

[0040] Figure 5 This is a schematic diagram of the puncture needle;

[0041] Figure 6 This is a structural schematic diagram of the anchoring component;

[0042] Figure 7 This is a diagram illustrating how the stitches are threaded.

[0043] Figure 8 This is a schematic diagram showing the anchoring element installed on the puncture needle;

[0044] Figure 9 This is a schematic diagram of the No. 3 anchor being placed on the right atrium side;

[0045] Figure 10 This is a schematic diagram of a ring of stitches;

[0046] Figure 11 This is a schematic diagram of a suture device with three first channels;

[0047] Figure 12 This is a schematic diagram of the structure of a two-loop suture ring;

[0048] Figure 13 This is a schematic diagram of the assembly consisting of a guidewire structure and a sheath. Figure 1 ;

[0049] Figure 14 This is a schematic diagram of the assembly consisting of a guidewire structure and a sheath. Figure 2 .

[0050] In the diagram: 1. Delivery pipe;

[0051] 11. First channel; 12. Second channel; 111. Channel 1; 112. Channel 2; 13. Puncture port; 14. Auxiliary groove;

[0052] 21. Puncture needle; 22. Anchor; 23. Suture;

[0053] 31. Guidewire body; 32. Support component; 33. Sheath;

[0054] 211. Puncture channel; 212. Tip; 213. Impact protrusion; 214. Circumvention groove;

[0055] 221. Fitting part; 222. Limiting part; 223. First through hole; 224. Second through hole; 225. Second inclined surface. Detailed Implementation

[0056] The present invention is described below based on embodiments, but the present invention is not limited to these embodiments. In the following detailed description of the present invention, some specific details are described in detail, but well-known methods, processes, procedures, and elements are not described in detail in order to avoid obscuring the essence of the present invention.

[0057] Furthermore, those skilled in the art should understand that the accompanying drawings provided herein are for illustrative purposes only and are not necessarily drawn to scale.

[0058] Unless the context explicitly requires it, the words "comprising," "including," and similar terms throughout the specification and claims should be interpreted as encompassing rather than being exclusive or exhaustive; that is, meaning "including but not limited to."

[0059] In the description of this invention, it should be understood that the terms "first," "second," etc., are used for descriptive purposes only and should not be construed as indicating or implying relative importance. Furthermore, in the description of this invention, unless otherwise stated, "a plurality of" means two or more.

[0060] In this invention, during surgery, the side furthest from the operator is called "far" (the side closer to the heart), and the side closer to the operator is called "near" (the side furthest from the heart).

[0061] See Figures 1-14 The present invention provides a suturing device, including a delivery tube 1 and a puncture assembly. A first channel 11 is formed inside the delivery tube 1. The first channel 11 extends along the axial direction of the delivery tube 1. The proximal end of the first channel 11 penetrates the proximal end of the delivery tube 1. A puncture port 13 is provided on the side wall of the distal end of the delivery tube 1. The puncture port 13 communicates with the distal end of the first channel 11.

[0062] The first channel 11 includes a first channel 111 and a second channel 112 connected to each other. The proximal end of the first channel 111 passes through the proximal end of the delivery tube 1, and the axis of the first channel 111 is parallel to the axis of the delivery tube 1. From proximal to distal, the second channel 112 gradually tilts radially outward, and the distal end of the second channel 112 connects to the puncture port 13.

[0063] The puncture assembly includes a puncture needle 21 and a suture structure. The suture structure includes a suture 23 and at least three anchors 22. In the extension direction of the puncture needle 21, these anchors 22 are sequentially inserted at the distal end of the puncture needle 21. In the length direction of the anchors 22, a first through hole 223 and a second through hole 224 are sequentially provided. The first through hole 223 is located on the proximal side of the second through hole 224. From proximal to distal, these anchors 22 are connected in series by the suture 23. In any two adjacent anchors 22, the one on the proximal side is the first anchor and the one on the distal side is the second anchor. The suture 23 passes through the first through hole 223 of the first anchor, the second through hole 224 of the first anchor, the first through hole 223 of the second anchor, and the second through hole 224 of the second anchor.

[0064] The puncture assembly is inserted through the first channel 11, and the distal end of the puncture needle 21 can be inserted through the puncture port 13.

[0065] A first channel 11 is formed inside the delivery tube 1. The extension direction of most of the first channel 11 (channel 111) is consistent with the axis of the delivery tube 1. The distal part of the first channel 11 (channel 112) is radially outward and connected to the puncture port 13. The puncture needle 21 is basically straight under the action of no external force. The puncture needle 21 can bend and deform under the action of external force. After the external force is removed, it can return to the state under the action of no external force.

[0066] When the puncture needle 21 is located within the first channel 11, its shape is constrained by the channel. Therefore, the portion of the puncture needle 21 located within the first channel 111 maintains axial extension, while the distal portion located within the second channel 112 bends outward accordingly. The puncture needle 21 can move (advance or retract) along the first channel 11 under the action of an applied external force. When the puncture needle 21 is pushed distally, its tip 212 exits through the puncture port 13. The portion of the puncture needle 21 located outside the delivery tube 1 is no longer constrained by the channel, restoring its free, straight shape, and its initial direction is consistent with the axial direction of the second channel 112. Continuing to push the puncture needle 21 distally, its tip 212 moves outward and distally in this direction.

[0067] The distal end of the puncture needle 21 is provided with a suture structure, which includes multiple anchors 22, and the multiple anchors 22 are connected sequentially by sutures 23.

[0068] The connection method of the sutures 23 between the anchors 22 is as follows: taking three anchors 22 as an example, namely anchor 1, anchor 2 and anchor 3, the anchors 1, anchor 2 and anchor 3 are set on the puncture needle 21 in sequence from near to far. On each anchor 22, the first through hole is near and the second through hole is far. Along the axis of the through hole (the first through hole and the second through hole), the two sides of the anchor 22 are the first side and the second side, respectively. That is to say, the two ends of the first through hole and the second through hole are connected to the first side and the second side of the anchor 22, respectively.

[0069] See Figure 7 The thread 23 is threaded between the anchors 22 in the following manner: one end of the thread 23 passes through the first through hole of the first anchor from the first side of the first anchor, and then reaches the second side of the first anchor. It then passes through the second through hole of the first anchor from the second side of the first anchor and reaches the first side of the first anchor. Then, it passes through the first through hole of the second anchor from the first side of the second anchor and reaches the second side of the second anchor. Finally, it passes through the second through hole of the second anchor and reaches the first side of the second anchor. Similarly, the thread 23 passes through the first through hole and the second through hole of the third anchor, so that the three anchors 22 are connected in series.

[0070] Surgical application (taking patent foramen ovale closure as an example):

[0071] Positioning: The suture device is advanced along the artery (without the puncture needle 21 penetrating the puncture site 13), so that the distal end of the delivery tube 1 reaches the left atrial side of the interatrial septum. The distal end of the delivery tube 1 is then passed through the foramen ovale and positioned using the foramen ovale. At this point, the puncture site 13 is still located on the left atrial side of the interatrial septum.

[0072] Initial puncture and release: Advance the puncture needle 21 distally. The puncture needle 21 exits through the puncture site 13, extending obliquely outward (direction determined by channel 2 112), so that its tip 212 is radially away from the foramen ovale, thereby puncturing and penetrating the atrial septum tissue to reach the right atrium. Continue advancing the puncture needle 21, inserting the third anchor at its distal end into the right atrium. Then withdraw the puncture needle 21, with the needle tip returning to the left atrium. Figure 9 (See illustration). At this point, the atrial septum tissue blocked the retraction of the third anchor as the puncture needle 21 was withdrawn, thus leaving it on the right atrial side.

[0073] Rotation and Repetition: Rotate the delivery tube 1 clockwise by a certain angle (this angle = 360° / N, where N is the total number of anchors 22. For example, 120° when N=3; 90° when N=4). Since the puncture needle 21 is constrained by the first channel 11, its position relative to the foramen ovale rotates synchronously. Repeat the puncture and release process described above: push the puncture needle 21 to puncture the interatrial septum, insert the next (e.g., number two) anchor 22 into the right atrium and leave it in place; withdraw the puncture needle 21. Rotate the delivery tube 1 again by the same angle (120° or 90°), repeat the puncture and release process, and insert the remaining anchors 22 (e.g., number one) into the right atrium in sequence and leave them in place.

[0074] Tightening suture 23: At this point, all (N) anchors 22 are positioned on the right atrial side of the atrial septum and evenly distributed circumferentially around the foramen ovale (the more anchors 22 there are, the closer the distribution is to a circle). The suture segment 23 connecting the anchors 22 passes through the atrial septum tissue, located on the left atrial side, forming a suture loop around the foramen ovale. Tightening this suture 23 shortens the suture segment 23 between any two adjacent anchors 22, causing all anchors 22 to move towards the center (foramen ovale). This results in a uniform reduction in the size of the foramen ovale region surrounded by the anchors 22, ultimately achieving effective closure.

[0075] In the above process, the three anchors 22 are connected by the same suture 23. Therefore, when tightening the suture 23, the tightening force at various points on the suture 23 is basically the same. That is to say, the tightening force exerted by each anchor 22 on the intraatrial septum is basically the same, i.e., the tightening force acting around the foramen ovale is evenly and symmetrically distributed, ensuring that the foramen ovale closes evenly and reliably. Compared with the prior art method of tightening multiple sutures 23 simultaneously, each suture 23 is relatively independent during tightening, and the tightening force of each suture 23 on the foramen ovale is not the same. This leads to insufficient local tightening force on the foramen ovale after tightening, resulting in incomplete closure of the foramen ovale. The tightening suture of the present invention can tighten around the periphery of the foramen ovale, solving the problem of uneven tightening force when tightening multiple sutures 23.

[0076] This invention Figure 10 Fourteen anchors 22 are shown. In actual application, there are usually 3-5 anchors 22. On the one hand, the more anchors 22 there are, the more times the puncture needle 21 punctures the interatrial septum tissue, which will increase the operation time. On the other hand, too many anchors 22 will make the structure of the puncture assembly more complicated and make the operation inconvenient.

[0077] Furthermore, in the prior art, multiple puncture needles 21 are simultaneously inserted into the delivery tube 1, with each puncture needle 21 corresponding to a suture 23. The arrangement of multiple puncture needles 21 places higher demands on the radial dimensions of the delivery tube 1. In contrast, the suturing device of the present invention has only one suture 23, which means there is only one puncture needle 21. This not only reduces the processing difficulty of the first channel 11, but more importantly, the smaller diameter delivery tube 1 is easier to deliver within blood vessels, thus improving the feasibility and safety of interventional surgery.

[0078] Anchor 22 may be made of biodegradable materials, such as PDO (polydioxanone).

[0079] The puncture needle 21 has a puncture channel 211 formed inside it along its axial direction. The cross-section of the puncture channel 211 is circular. The side wall of the puncture needle 21 is also provided with a relief groove 214. In the radial direction, the relief groove 214 communicates with the puncture channel 211. The relief groove 214 is located at the distal end of the puncture needle 21. The distal end of the relief groove 214 penetrates the distal end of the puncture needle 21. The width of the relief groove 214 is smaller than the inner diameter of the puncture channel 211.

[0080] The anchoring member 22 includes a columnar mating part 221 and a plate-shaped limiting part 222. The limiting part 222 is connected to the outer peripheral surface of the mating part 221, and the length direction of the limiting part 222 is consistent with the length direction of the mating part 221. The thickness of the limiting part 222 matches the width of the clearance groove 214. The mating part 221 mates with the puncture channel 211, and the limiting part 222 extends out of the clearance groove 214. The first through hole 223 and the second through hole 224 are located on the limiting part 222 and are located outside the puncture needle 21.

[0081] The specific structure of the anchor 22 allows it to slide in conjunction with the puncture channel 211. Specifically, the columnar mating part 221 mates with the puncture channel 211, and the outer diameter of the mating part 221 matches the inner diameter of the puncture channel 211, so the mating part 221 can slide along the puncture channel 211. The side wall of the puncture needle 21 is provided with a relief groove 214, and a limiting part 222 is connected to the mating part 221. The limiting part 222 passes through the relief groove 214, meaning that the limiting part 222 can only slide along the relief groove 214. Therefore, the entire anchor 22 can only slide along the puncture channel 211, specifically within the relief groove 214. At the same time, when the anchor 22 is confined within the puncture channel 211, its limiting part 222 will extend out from the relief groove 214.

[0082] The anchor 22 slides into the puncture channel 211 of the puncture needle 21 via its columnar mating portion 221, while its plate-shaped limiting portion 222 extends out from the clearance groove 214 on the side wall of the puncture needle 21. When the puncture needle 21 carrying the anchor 22 passes through the interatrial septum, a puncture hole is formed in the tissue. Subsequently, when the puncture needle 21 is withdrawn, the limiting portion 222 of the anchor 22 is blocked by the interatrial septum tissue because its size is larger than the puncture hole, and it cannot be withdrawn with the needle. At the same time, since the distal end of the clearance groove 214 penetrates the tip 212 of the puncture needle 21, the anchor 22 can move distally along the clearance groove 214, and finally detach from the puncture needle 21 at the distal end of the clearance groove 214, thus being stably placed on the right atrial side of the interatrial septum.

[0083] The distal end of the mating part 221 is provided with a first cut, so that the distal end of the mating part 221 forms a first inclined surface. From far to near, the first inclined surface is inclined toward the side away from the limiting part 222. The distal end of the limiting part 222 is provided with a second cut, so that the distal end of the limiting part 222 forms a second inclined surface 225. From far to near, the second inclined surface 225 is inclined toward the side away from the mating part 221. The first inclined surface and the second inclined surface 225 together constitute a cone.

[0084] The tapered design allows the anchor 22 to smoothly transition through the tissue puncture: as the tip 212 of the puncture needle 21 continues to advance the anchor 22 after passing through the puncture, its distal tapered portion (especially the second inclined surface 225 of the limiting portion 222 protruding from the outside of the puncture needle 21) can progressively expand the puncture, thereby significantly reducing the resistance of the anchor 22 and ensuring its smooth passage through the tissue.

[0085] The puncture needle 21 includes a first part and a second part connected to each other. The length of the second part is equal to the length of the clearance groove 214, and the clearance groove 214 is located in the second part.

[0086] The inner wall of the second part is provided with a plurality of impact protrusions 213. Along the length direction of the second part, the plurality of impact protrusions 213 are equally spaced. The number of impact protrusions 213 is A, and the number of anchoring members 22 is B, BA=1. When all the anchoring members 22 are located in the second part, B anchoring members 22 and A impact protrusions 213 are staggered. Each pair of adjacent anchoring members 22 is separated by an impact protrusion 213.

[0087] The impact protrusion 213 has a stop portion facing distally to prevent the anchor 22 from moving proximally along the puncture needle 21.

[0088] During the surgical procedure, the stop portion of the impact protrusion 213 provides proximal restraint to the anchor 22: as the puncture needle 21, carrying the anchor 22, continues to advance after passing through the tissue puncture hole, the stop portion abuts against the proximal surface of the anchor 22, forcing the anchor 22 to move distally synchronously with the puncture needle 21. For example, the distal impact protrusion 213 prevents the third anchor from retracting proximally, ensuring that it completely passes through the puncture hole and reaches the target position (such as the right atrial side of the interatrial septum).

[0089] In the second part, a U-shaped slit is formed on the side wall of the puncture needle 21, and the impact protrusion 213 is formed within the U-shaped slit. The opening of the U-shape constitutes the root of the impact protrusion 213. On the impact protrusion 213, the end corresponding to the root is the free end of the impact protrusion 213. In the radial direction of the second part, the impact protrusion 213 bends inward around its root, so that the free end of the impact protrusion 213 is located within the puncture channel 211. On the impact protrusion 213, its root is located on the proximal side of its free end. A guide slope is formed on the inner surface of the impact protrusion 213. The guide slope is radially inclined inward from near to far. The free end of the impact protrusion 213 constitutes the stop portion.

[0090] As the anchor 22 slides along the second portion toward the distal end, the anchor 22 can press the impact protrusion 213 outward along the guide ramp, so that the impact protrusion 213 is flattened, allowing the anchor 22 to pass over the impact protrusion 213 in one direction.

[0091] Structural implementation of impact protrusion 213:

[0092] On the second part of the sidewall, an impact protrusion 213 is formed by a U-shaped cut. The open end of the U-shape forms the root of the impact protrusion 213, and its opposite side is the free end. In its natural state, the impact protrusion 213 bends around the root into the puncture channel 211, so that the free end extends into the channel to form a stop.

[0093] One-way limit mechanism:

[0094] The inner surface of the impact protrusion 213 is provided with a guide slope that is radially inward from the proximal end to the distal end. When the anchor 22 slides to the distal end, it presses against the guide slope, forcing the impact protrusion 213 to elastically deform to be flush with the inner wall of the puncture needle 21, allowing the anchor 22 to pass through in one direction; when the anchor 22 moves in the opposite direction, the free end forms a rigid stop.

[0095] Key role in surgery:

[0096] If the anchor 22 (such as anchor 1) is blocked by tissue and cannot be retracted, it will move distally relative to the puncture needle 21. At this time, the anchor 22 slides along the guide ramp, flattens and passes over the distal impact protrusion 213, ensuring that it can only be disengaged from the puncture needle 21 in one direction.

[0097] It also includes a push rod that passes through the puncture channel 211 to push the anchor 22 from the proximal side to the distal side.

[0098] Taking three anchors 22 as an example, after the third anchor is released, the puncture needle 21 retracts to the initial position; the first anchor is pushed to the distal end by the push rod, so that it passes the distal impact protrusion 213; the first anchor pushes the second anchor to move synchronously, and the two reach the original positions of the second and third anchors respectively; when puncturing again, the puncture needle 21 only needs to reach the original depth to implant the currently distal second anchor into the target tissue.

[0099] The push rod design enables sequential and progressive positioning of the anchor 22, avoiding repeated adjustments to the puncture depth, significantly shortening the operation time and reducing the risk of tissue damage.

[0100] The delivery pipe 1 is also provided with a strip-shaped auxiliary groove 14, which extends along the axial direction of the delivery pipe 1. The distal end of the auxiliary groove 14 is connected to the puncture port 13, and the radial inner side of the auxiliary groove 14 extends to the first channel 11. The clearance groove 214 is directly connected to the auxiliary groove 14, and the portion of the limiting part 222 that extends out of the clearance groove 214 passes through the auxiliary groove 14.

[0101] The auxiliary groove 14 serves as an extension channel of the clearance groove 214, ensuring that the anchor 22 on the puncture needle 21 (especially the part extending outward from the puncture needle 21) can slide smoothly.

[0102] A second channel 12 is also formed inside the conveying pipe 1. The second channel 12 extends along the axial direction of the conveying pipe 1 and passes through both ends of the conveying pipe 1. The first channel 11 and the second channel 12 are not connected to each other.

[0103] The suturing device also includes a guide wire structure, which passes through the second channel 12.

[0104] The guidewire structure facilitates the guidance of the delivery tube 1 into the target location (heart).

[0105] The guide wire structure includes a guide wire body 31 and a support member 32 connected to the distal end of the guide wire body 31. The support member 32 is made of nickel-titanium alloy wire. In its natural state, the support member 32 is triangular. The distal end of the guide wire body 31 is connected to one corner of the support member 32, and the plane of the support member 32 is perpendicular to the extension direction of the distal end of the guide wire body 31.

[0106] The guide wire structure has a first state and a second state relative to the delivery tube 1.

[0107] In the first state, the support member 32 is strip-shaped and is housed in the distal end of the second channel 12;

[0108] The guide wire structure is delivered to the distal end, so that the support member 32 extends out of the distal end of the second channel 12, and the guide wire structure is switched from the first state to the second state.

[0109] In the second state, the support member 32 unfolds into a triangle, and the far end of the second channel 112 points to the center of the triangular support member 32.

[0110] During the procedure, the assembly consisting of the guidewire and sheath 33 is passed through the foramen ovale to the right atrium. Figure 13 (As shown); retract the sheath 33, and the support 32 automatically unfolds into a triangle ( Figure 14(As shown); the distal end of the delivery tube 1 is inserted into the foramen ovale along the guidewire. At this time, the distal end of the second channel 112 is precisely aligned with the geometric center of the triangular support 32. When the puncture needle 21 penetrates the interatrial septum, the triangular support 32 provides reverse support force to the tissue on the opposite side, ensuring the accuracy and safety of the puncture.

[0111] The number of first channels 11 is two or three. Along the axial direction of the conveying pipe 1, these first channels 11 are arranged at equal angles around the axis of the conveying pipe 1. The inclination angles of the second channels 112 of these first channels 11 are different (for example, the number of first channels 11 is three, and the angles are 15°, 30° and 45° respectively).

[0112] Each of the first channels 11 corresponds to one of the puncture components;

[0113] The number of the support members 32 is the same as the number of the first channels 11. These support members 32 are evenly arranged around the distal end of the guide wire body 31. The size of these support members 32 is different. In the second state, the second channels 112 point one-to-one to the center of the triangular support members 32. The smaller the inclination angle of the second channel 112, the smaller the size of the corresponding support member 32 (e.g., a 15° channel is paired with a triangle with a side length of 6mm, and a 45° channel is paired with a triangle with a side length of 10mm).

[0114] Several first channels 11 are simultaneously set, and the inclination angle of each second channel 112 is different. Therefore, each puncture component can independently form a suture ring around the outside of the foramen ovale. The larger the inclination angle of the second channel 112, the larger the diameter of the suture ring. Figure 12 The embodiment shown forms a double suture loop to ensure a sealing effect on the oval foramen.

[0115] It should be understood that the above embodiments are merely exemplary and not restrictive. Various obvious or equivalent modifications or substitutions that can be made by those skilled in the art regarding the above details without departing from the basic principles of the present invention will be included within the scope of the claims of the present invention.

Claims

1. A suturing device, characterized in that, The device includes a delivery tube and a puncture assembly. A first channel is formed inside the delivery tube, and the first channel extends along the axial direction of the delivery tube. The proximal end of the first channel penetrates the proximal end of the delivery tube. A puncture port is provided on the side wall of the distal end of the delivery tube, and the puncture port communicates with the distal end of the first channel. The first channel includes a first channel and a second channel that are connected to each other. The proximal end of the first channel extends through the proximal end of the delivery pipe, and the axis of the first channel is parallel to the axis of the delivery pipe. From near to far, the second channel gradually tilts radially outward, and the distal end of the second channel connects to the puncture site; The puncture assembly includes a puncture needle and a suture structure. The suture structure includes a suture and at least three anchors. In the extension direction of the puncture needle, these anchors are sequentially inserted at the distal end of the puncture needle. In the length direction of the anchors, a first through hole and a second through hole are sequentially provided. The first through hole is located on the proximal side of the second through hole. From proximal to distal, these anchors are connected in series by the suture. In any two adjacent anchors, the one on the proximal side is the first anchor and the one on the distal side is the second anchor. The suture passes through the first through hole of the first anchor, the second through hole of the first anchor, the first through hole of the second anchor, and the second through hole of the second anchor. The puncture assembly is inserted through the first channel, and the distal end of the puncture needle can be inserted through the puncture port. The puncture needle has a puncture channel formed along its axial direction. The cross-section of the puncture channel is circular. The side wall of the puncture needle is also provided with a relief groove. In the radial direction, the relief groove communicates with the puncture channel. The relief groove is located at the distal end of the puncture needle. The distal end of the relief groove penetrates the distal end of the puncture needle. The width of the relief groove is smaller than the inner diameter of the puncture channel. The anchoring member includes a columnar mating part and a plate-shaped limiting part. The limiting part is connected to the outer peripheral surface of the mating part, and the length direction of the limiting part is consistent with the length direction of the mating part. The thickness of the limiting part matches the width of the clearance groove. The mating part mates with the puncture channel, and the limiting part extends out of the clearance groove. The first through hole and the second through hole are located on the limiting part and are located outside the puncture needle. The distal end of the mating part is provided with a first cut, so that the distal end of the mating part forms a first inclined surface. From far to near, the first inclined surface is inclined toward the side away from the limiting part; the distal end of the limiting part is provided with a second cut, so that the distal end of the limiting part forms a second inclined surface. From far to near, the second inclined surface is inclined toward the side away from the mating part. The first inclined surface and the second inclined surface together constitute a cone. The puncture needle includes a first part and a second part connected to each other, the length of the second part being equal to the length of the clearance groove, and the clearance groove being located in the second part. The inner wall of the second part is provided with a plurality of impact protrusions. Along the length direction of the second part, the plurality of impact protrusions are equally spaced. The number of impact protrusions is A, and the number of anchors is B, BA=1. When all the anchors are located in the second part, B anchors and A impact protrusions are staggered. Each pair of adjacent anchors is separated by an impact protrusion. The impact protrusion has a stop portion facing distally to prevent the anchor from moving proximally along the puncture needle.

2. The suturing device according to claim 1, characterized in that, In the second part, a U-shaped slit is formed on the side wall of the puncture needle, and the impact protrusion is formed within the U-shaped slit. The opening of the U-shape constitutes the root of the impact protrusion. On the impact protrusion, the end corresponding to the root is the free end of the impact protrusion. In the radial direction of the second part, the impact protrusion bends inward around its root, so that the free end of the impact protrusion is located within the puncture channel. On the impact protrusion, its root is located on the proximal side of its free end. A guide slope is formed on the inner surface of the impact protrusion. The guide slope is radially inclined inward from proximal to distal. The free end of the impact protrusion constitutes the stop portion. As the anchor slides along the second portion toward the distal end, the anchor can press the impact protrusion outward along the guide ramp, flattening the impact protrusion and allowing the anchor to pass over the impact protrusion in one direction.

3. The suturing device according to any one of claims 1-2, characterized in that, It also includes a push rod that passes through the puncture channel to push the anchor from the proximal side to the distal side.

4. The suturing device according to any one of claims 1-2, characterized in that, The delivery pipe is also provided with a strip-shaped auxiliary groove, which extends along the axial direction of the delivery pipe. The distal end of the auxiliary groove is connected to the puncture port, and the radially inner side of the auxiliary groove extends to the first channel. The clearance groove is directly connected to the auxiliary groove, and the portion of the limiting part that extends out of the clearance groove passes through the auxiliary groove.

5. The suturing device according to any one of claims 1-2, characterized in that, A second channel is also formed inside the conveying pipe. The second channel extends along the axial direction of the conveying pipe and passes through both ends of the conveying pipe. The first channel and the second channel are not connected to each other. The suturing device also includes a guide wire structure that passes through the second channel.

6. The suturing device according to claim 5, characterized in that, The guide wire structure includes a guide wire body and a support member connected to the distal end of the guide wire body. The support member is made of nickel-titanium alloy wire. In its natural state, the support member is triangular. The distal end of the guide wire body is connected to one corner of the support member, and the plane of the support member is perpendicular to the extension direction of the distal end of the guide wire body. The guide wire structure has a first state and a second state relative to the delivery tube. In the first state, the support member is strip-shaped and is housed within the distal end of the second channel; The guide wire structure is delivered to the distal end, causing the support member to extend beyond the distal end of the second channel, thereby switching the guide wire structure from the first state to the second state. In the second state, the support member unfolds into a triangle, with the far end of the second channel pointing towards the center of the triangular support member.

7. The suturing device according to claim 6, characterized in that, The number of the first channels is two or three. Along the axial direction of the conveying pipe, these first channels are arranged at equal angles around the axis of the conveying pipe, and the inclination angles of the second channels of these first channels are different. Each of the first channels corresponds to one of the puncture components; The number of the support members is the same as the number of the first channels. These support members are evenly arranged around the distal end of the guide wire body. The size of these support members is different. In the second state, the second channels point one-to-one to the center of the triangular support members. The smaller the inclination angle of the second channel, the smaller the size of the corresponding support member.

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