A suture assembly

Abstract

The present application relates to a kind of suture assembly, including suture device, suture device includes delivery tube and puncture assembly, first passage and second passage are formed in delivery tube, first passage extends along the axial direction of the delivery tube, the proximal end of first passage penetrates the proximal end of the delivery tube, the side wall of the distal end of delivery tube is provided with puncture port, and the distal end of first passage is communicated with puncture port;Second passage extends along the axial direction of the delivery tube;First passage includes primary channel and secondary channel, the proximal end of the primary channel penetrates the proximal end of the delivery tube, and the axis of the primary channel is parallel to the axis of the delivery tube;From near to far, the secondary channel gradually radially outwardly inclines, and the distal end of the secondary channel is communicated with the puncture port;The puncture assembly is arranged in the first passage, and the distal end of the puncture needle can be penetrated from the puncture port. It can reduce the difficulty of operation, improve the closure effect of foramen ovale, and reduce the probability of complication.

Description

Technical Field

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

[0002] Patent foramen ovale (PFO) is a congenital heart defect in which 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 about 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 kits all use multiple sutures tied at a single point to suture the PFO. For example, CN117426818A discloses a suturing kit for interventional treatment in which multiple puncture devices pass through the interatrial septum, and 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 suture assembly 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 suture assembly 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 assembly includes a suturing device and a guide wire assembly. The suturing device includes a delivery tube and a puncture assembly. A first channel and a second channel are formed within the delivery tube. The first channel extends axially along the delivery tube and its proximal end 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 second channel extends axially along the delivery tube and penetrates both ends of the delivery tube. The first channel and the second channel are not interconnected.

[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 connected to each other by the suture. The suture structure is disposed at the distal end of the puncture needle, which passes through the first channel. The distal end of the puncture needle can exit through the puncture site along the first channel to implant the anchors into the target location.

[0010] The guidewire assembly includes a guidewire structure, which includes a guidewire body and a support member connected to the distal end of the guidewire body. In its natural state, the support member is triangular, and there are two support members, namely a first support member and a second support member. The first support member is located on the proximal side of the second support member, and one corner of the second support member is connected to the distal end of the guidewire body. The first support member and the second support member are spaced 7-15mm apart along the axial direction of the guidewire body, and their projections overlap.

[0011] The guidewire structure passes through the second channel.

[0012] Preferably, the guidewire assembly further includes a sheath, and the guidewire structure has a first state and a second state;

[0013] In the first state, the two support members are compressed into a strip shape. The first support member is folded towards the proximal side and brought together with the guidewire body. The second support member is folded towards the distal side and parallel to the guidewire body, so that the guidewire structure in the first state can be inserted into the sheath.

[0014] After the sheath is withdrawn, the guidewire structure switches from the first state to the second state;

[0015] In the second state, the first support member and the second support member unfold into a triangle;

[0016] The second channel passes through the guide wire body to guide the distal end of the delivery tube to the target location;

[0017] When the distal end of the delivery pipe reaches the target position, the distal end of the second channel points to the central region of the first and second triangular supports.

[0018] Preferably, in the extension direction of the puncture needle, these anchors are sequentially inserted into 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 sutures. 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.

[0019] The puncture assembly is inserted through the first channel, and the distal end of the puncture needle can exit through the puncture port.

[0020] Preferably, the guide wire assembly further includes a flow-blocking membrane, which is circular and has a through hole at its center. The flow-blocking membrane is sleeved on the outside of the guide wire body through the through hole, and the flow-blocking membrane is located between the first support member and the second support member.

[0021] 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.

[0022] 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.

[0023] 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.

[0024] 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.

[0025] The impact protrusion has a stop portion facing distally to prevent the anchor from moving proximally along the puncture needle.

[0026] 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.

[0027] 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.

[0028] 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.

[0029] 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.

[0030] Each of the first channels corresponds to one of the puncture components;

[0031] The first and second supports, which are arranged opposite to each other, constitute a support group. The number of support groups is the same as the number of the first channels. These support groups are evenly arranged around the distal end of the guide wire body and correspond one-to-one with several second channels.

[0032] Preferably, the inclination angles of the second channels of the first channels are different, and the sizes of the support groups are different. The smaller the inclination angle of the second channel, the smaller the size of the support member of the corresponding support group.

[0033] The beneficial effects of this invention are:

[0034] 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.

[0035] When closing the foramen ovale using the present invention, the guidewire assembly is first delivered along the blood vessel so that the distal end of the guidewire assembly passes through the foramen ovale and the gap between the first support and the second support crosses the foramen ovale. The sheath is then withdrawn to the proximal side, and the second support first protrudes from the sheath. The second support unfolds into a triangle, and then the first support protrudes from the sheath. Since the gap between the first support and the second support crosses the foramen ovale, the unfolded first support and the second support are located on both sides of the atrial septum tissue.

[0036] The delivery tube is advanced along the guidewire structure, with its distal end close to the first support, aligning the second channel with the center of the first support. 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 through the puncture site along the second channel and pierces the center of the first support. The tip of the puncture needle passes through the first support and pierces the interatrial septum. The puncture needle, carrying the distal anchor, passes through the interatrial septum. The puncture needle is then withdrawn proximally, and its distal end returns to the other side. During withdrawal, the distal end of the puncture needle... The first anchor is left on the other side of the atrial septum. The delivery tube is rotated 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 on the other side of the atrial septum (right atrial side). These anchors are evenly distributed around the periphery of the foramen ovale on the other side of the atrial septum. Since these anchors are connected by sutures, a single suture is used to suture around the periphery of the foramen ovale. The suture is then tightened, reducing the diameter of the suture loop and gradually shrinking the foramen ovale until it is closed.

[0037] When the puncture needle punctures the atrial septum, a second support component on the back of the atrial septum provides support, ensuring that the puncture needle can effectively penetrate the atrial septum and facilitate the implantation of the anchoring device into the right atrium of the atrial septum. When the puncture needle is withdrawn, the atrial septum deforms towards the left atrium under the action of the puncture needle. The first support component supports the atrial septum on the left atrium, ensuring that the tip of the puncture needle can be withdrawn to the left atrium, thus enabling the interventional procedure to proceed smoothly. Attached Figure Description

[0038] 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:

[0039] Figure 1 This is a schematic diagram of the stitching assembly;

[0040] Figure 2 This is a cross-sectional view of the delivery pipe;

[0041] Figure 3 This is a schematic diagram of the conveying pipe structure;

[0042] Figure 4 This is a cross-sectional view of the puncture needle;

[0043] Figure 5 This is a schematic diagram of the puncture needle;

[0044] Figure 6 This is a structural schematic diagram of the anchoring component;

[0045] Figure 7 This is a diagram illustrating how the stitches are threaded.

[0046] Figure 8 This is a schematic diagram showing the anchoring element installed on the puncture needle;

[0047] Figure 9 This is a schematic diagram of the No. 3 anchor being placed on the right atrium side;

[0048] Figure 10 This is a schematic diagram of a ring of stitches;

[0049] Figure 11 This is a schematic diagram of the suture assembly for the three first channels;

[0050] Figure 12 This is a schematic diagram of the structure of a two-loop suture ring;

[0051] Figure 13 This is a schematic diagram of a stitching assembly with a flow-blocking membrane;

[0052] Figure 14 This is a schematic diagram of the guidewire structure in the first state;

[0053] Figure 15 This is the guidewire assembly in its first state;

[0054] Figure 16 This is the guidewire assembly in its second state;

[0055] Figure 17 This is a schematic diagram of the first and second support members retracting into the sheath.

[0056] In the diagram: 1. Delivery pipe;

[0057] 11. First channel; 12. Second channel; 111. Channel 1; 112. Channel 2; 13. Puncture port; 14. Auxiliary groove;

[0058] 21. Puncture needle; 22. Anchor; 23. Suture;

[0059] 31. Guidewire body; 32. Second support member; 33. First support member; 34. Flow-blocking membrane; 35. Sheath;

[0060] 211. Puncture channel; 212. Tip; 213. Impact protrusion; 214. Circumvention groove;

[0061] 221. Fitting part; 222. Limiting part; 223. First through hole; 224. Second through hole; 225. Second inclined surface. Detailed Implementation

[0062] 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.

[0063] 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.

[0064] 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."

[0065] 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.

[0066] 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).

[0067] See Figures 1-17 The present invention provides a suturing assembly, including a suturing device and a guide wire assembly. The suturing device includes a delivery tube 1 and a puncture assembly. A first channel 11 and a second channel 12 are formed within the delivery tube 1. The first channel 11 extends axially along the delivery tube 1, and its proximal end 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, and the puncture port 13 communicates with the distal end of the first channel 11. The second channel 12 extends axially along the delivery tube 1 and penetrates both ends of the delivery tube 1. The first channel 11 and the second channel 12 are not interconnected.

[0068] 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.

[0069] 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 connected to each other by the suture 23. The suture structure is disposed at the distal end of the puncture needle 21. The puncture needle 21 passes through the first channel 11, and the distal end of the puncture needle 21 can pass through the puncture port 13 along the first channel 11 to implant the anchors 22 into the target position.

[0070] The guidewire assembly includes a guidewire structure, which includes a guidewire body 31 and a support member connected to the distal end of the guidewire body 31. In its natural state, the support member is triangular, and there are two support members, namely a first support member 33 and a second support member 32. The first support member 33 is located on the proximal side of the second support member 32, and one corner of the second support member 32 is connected to the distal end of the guidewire body 31. The first support member 33 and the second support member 32 are spaced 7-15mm apart along the axial direction of the guidewire body 31 (e.g., 7mm, 8mm, 10mm, 12mm, 15mm, etc.), and their projections overlap.

[0071] The guide wire structure is inserted through the second channel 12.

[0072] 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.

[0073] 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.

[0074] A second channel 12 is formed inside the conveying pipe 1. The second channel 12 is completely parallel to the axial direction of the conveying pipe 1. The guide wire structure passes through the second channel 12, thereby facilitating the conveying of the conveying pipe 1.

[0075] When performing surgery using the suture assembly, the guidewire structure is inserted into the sheath 35. The support of the guidewire structure is made of nickel-titanium alloy and is compressed into a strip shape, which is then housed within the sheath 35, making the entire guidewire assembly resemble a guidewire. The guidewire assembly is first delivered along the blood vessel, so that the distal end of the guidewire assembly reaches the left atrium. Then, the distal end of the guidewire assembly is controlled to pass through the foramen ovale, and the gap on the guidewire body 31 is made to cross the foramen ovale (this gap is the part of the guidewire body 31 between the connection points of the two support members and the guidewire body 31). Then, keeping the guidewire body 31 stationary, the sheath 35 is withdrawn proximally, and the second support member 32 and the first support member 33 will be exposed from the sheath 35 in sequence. Since the gap crosses the foramen ovale, the second support member 32 is located on the right atrium and the first support member 33 is located on the left atrium.

[0076] Initial puncture and release: The delivery tube 1 is inserted through its second channel 12 onto the outside of the guidewire assembly (in the guidewire assembly, the guidewire structure is inserted inside the sheath 35), allowing the delivery tube 1 to be delivered along the guidewire assembly (the guidewire body 31 and the sheath remain stationary), thereby enabling the distal end of the delivery tube 1 to reach the left atrial side, and the second channel 112 to point towards the central region of the first support 33. Keeping the delivery tube 1 stationary, the puncture needle 21 is pushed distally, exiting from the puncture port 13 and extending obliquely outward (the direction is determined by the second channel 112), so that its tip 212 is radially away from the foramen ovale, thereby passing through the first support 33 and piercing the interatrial septum tissue, delivering the most distal anchor 22 into the right atrial side. Subsequently, the puncture needle 21 is withdrawn, and the needle tip returns to the left atrial side. Figure 9 (See illustration). At this time, the atrial septum tissue blocks the anchor 22 located on the right atrial side from being withdrawn with the puncture needle 21, thus leaving it on the right atrial side.

[0077] Rotation and Repetition: Rotate the delivery tube 1 clockwise by a certain angle (the guidewire structure also rotates by the same 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 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 into the right atrium in sequence and leave them in place.

[0078] The guidewire structure is withdrawn, allowing the second support 32 to return to the left atrial side, thus preventing the foramen ovale from gripping the guidewire structure when the suture 23 is tightened later, which would prevent the guidewire structure from being withdrawn.

[0079] 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.

[0080] Since the second support 32 was already located on the left atrial side before the suture 23 was tightened, the guidewire assembly did not pass through the foramen ovale, thus allowing the guidewire assembly and suture device to be withdrawn smoothly.

[0081] Specifically, the guidewire structure can be pulled proximally (keeping the sheath 35 in place) so that the first support 33 and the second support 32 of the guidewire structure enter the sheath in sequence (both the first support 33 and the second support 32 are folded distally, see...). Figure 17 The sheath 35 compresses the first support 33 and the second support 32 into a strip shape, and then the suture device and the guide wire assembly are withdrawn in sequence.

[0082] During the above process, when the puncture needle 21 punctures the atrial septum tissue, the second support member 32 on the back of the atrial septum tissue provides support for the atrial septum tissue, ensuring that the puncture needle 21 can effectively penetrate the atrial septum tissue, facilitating the implantation of the anchoring member 22 into the right atrial side of the atrial septum; when the puncture needle 21 is withdrawn, the atrial septum tissue will deform towards the left atrial side under the action of the puncture needle 21, and the first support member 33 supports the atrial septum tissue on the left atrial side, ensuring that the tip 212 of the puncture needle 21 can be withdrawn back to the left atrial side, thus enabling the interventional procedure to proceed smoothly.

[0083] In addition, the thickness of the atrial septum is generally around 5-12mm. The specific value of this interval should be determined according to the actual thickness of the atrial septum in the patient. The interval between the first support 33 and the second support 32 should be slightly larger than the actual thickness of the atrial septum (for example, 1-2mm larger than the actual thickness of the atrial septum), so that the first support 33 and the second support 32 can be located on both sides of the atrial septum and provide effective support for the atrial septum, which facilitates the smooth implementation of the surgery.

[0084] The guidewire assembly also includes a sheath 35, and the guidewire structure has a first state and a second state;

[0085] See Figure 14 and Figure 15 In the first state, the two support members are compressed into a strip shape. The first support member 33 is folded towards the proximal side and joined to the guide wire body 31. The second support member 32 is folded towards the distal side and parallel to the guide wire body 31, so that the guide wire structure in the first state can be inserted into the sheath tube 35.

[0086] See Figure 16 After the sheath 35 is pulled out, the guidewire structure switches from the first state to the second state;

[0087] In the second state, the first support member 33 and the second support member 32 unfold into a triangle;

[0088] The second channel 12 passes through the guide wire body 31 to guide the distal end of the delivery tube 1 to the target position;

[0089] When the distal end of the delivery tube 1 reaches the target position (left atrial side), the distal end of the second channel 112 points to the central region of the first triangular support 33 and the second triangular support 32.

[0090] When the guidewire structure is inserted into the sheath 35 to form the guidewire assembly, the guidewire structure is located in the sheath 35 in the first state. The second support member 32 is folded distally, so that the folding direction of the second support member 32 is away from the first support member 33. The first support member 33 is folded proximally, so that the folding direction of the first support member 33 is away from the second support member 32. This prevents the two from overlapping. Therefore, when the sheath 35 is withdrawn, the second support member 32 unfolds first, flips proximally, and approaches the right side of the atrial septum. Similarly, the first support member 33 unfolds later, flips distally, and approaches the left side of the atrial septum. This allows the two to effectively clamp the atrial septum and ensure the smooth progress of the operation.

[0091] In the first state, the two supports fold away from each other so that they do not overlap, and therefore they do not affect each other when switching from the first state to the second state.

[0092] In the extension direction of the puncture needle 21, these anchoring elements 22 are sequentially inserted into the distal end of the puncture needle 21. In the length direction of the anchoring element 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 anchoring elements 22 are connected in series by sutures 23. In any two adjacent anchoring elements 22, the one on the proximal side is the first anchoring element and the one on the distal side is the second anchoring element. The sutures 23 pass through the first through hole 223 of the first anchoring element, the second through hole 224 of the first anchoring element, the first through hole 223 of the second anchoring element, and the second through hole 224 of the second anchoring element.

[0093] 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.

[0094] 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.

[0095] 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 in sequence on the puncture needle 21 from near to far. On each anchor 22, the first through hole 223 is near and the second through hole 224 is far. Along the axis of the through holes (first through hole 223 and second through hole 224), 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 223 and the second through hole 224 are connected to the first side and the second side of the anchor 22, respectively.

[0096] See Figure 7The thread 23 is threaded between the anchors 22 in the following manner: one end of the thread 23 passes through the first through hole 223 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 224 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 223 of the second anchor from the first side of the second anchor, and reaches the second side of the second anchor. It then passes through the second through hole 224 of the second anchor, and reaches the first side of the second anchor. Similarly, the thread 23 passes through the first through hole 223 and the second through hole 224 of the third anchor, so that the three anchors 22 are connected in series.

[0097] 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.

[0098] 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 suture assembly 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.

[0099] Anchor 22 may be made of biodegradable materials, such as PDO (polydioxanone).

[0100] The guide wire assembly also includes a flow-blocking membrane 34, which is circular and has a through hole at its center. The flow-blocking membrane 34 is sleeved on the outside of the guide wire body 31 through the through hole, and the flow-blocking membrane 34 is located between the first support member 33 and the second support member 32.

[0101] In some cases, after tightening the suture 23, the foramen ovale may not be completely closed due to its excessive size, thus failing to achieve the surgical objective. The present invention provides a flow-blocking membrane 34 in the first support member 33 and the second support member 32. The perforation of the flow-blocking membrane 34 is slightly larger than the outer diameter of the guidewire body 31. When the puncture needle 21 punctures the interatrial septum tissue, the puncture needle 21 also passes through the flow-blocking membrane 34, causing the flow-blocking membrane 34 and the interatrial septum to be sutured together. Furthermore, the perforation on the flow-blocking membrane 34 is precisely aligned with the foramen ovale. Therefore, when the suture 23 is tightened, the flow-blocking membrane 34 is also tightened, causing the perforation to shrink. Since the perforation is much smaller than the size of the foramen ovale, the tightened suture 23 can easily close the perforation, thereby achieving the purpose of closing the foramen ovale through the flow-blocking membrane 34.

[0102] 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.

[0103] 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.

[0104] 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.

[0105] 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.

[0106] 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.

[0107] 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.

[0108] 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.

[0109] 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.

[0110] The impact protrusion 213 has a stop portion facing distally to prevent the anchor 22 from moving proximally along the puncture needle 21.

[0111] 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).

[0112] 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.

[0113] 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.

[0114] Structural implementation of impact protrusion 213:

[0115] 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.

[0116] One-way limit mechanism:

[0117] 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.

[0118] Key role in surgery:

[0119] 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.

[0120] 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.

[0121] 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.

[0122] 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.

[0123] 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.

[0124] 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.

[0125] The number of the first channels 11 is two or three, and these first channels 11 are arranged at equal angles around the axis of the conveying pipe 1 in the axial direction of the conveying pipe 1.

[0126] Each of the first channels 11 corresponds to one of the puncture components;

[0127] The first support member 33 and the second support member 32, which are arranged opposite to each other, constitute a support group. The number of the support groups is the same as the number of the first channels 11. These support groups are evenly arranged around the distal end of the guide wire body 31 and correspond one-to-one with several second channels 112.

[0128] The inclination angles of the second channels 112 of the first channel 11 are different, and the dimensions of these support groups are different. The smaller the inclination angle of the second channel 112, the smaller the size of the support component of the corresponding support group (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).

[0129] 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.

[0130] 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 suture assembly, characterized in that, The device includes a suturing apparatus and a guide wire assembly. The suturing apparatus includes a delivery tube and a puncture assembly. A first channel and a second channel are formed within the delivery tube. The first channel extends axially along the delivery tube and its proximal end 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 second channel extends axially along the delivery tube and penetrates both ends of the delivery tube. The first channel and the second channel are not interconnected. 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 connected to each other by the suture. The suture structure is disposed at the distal end of the puncture needle, which passes through the first channel. The distal end of the puncture needle can exit through the puncture site along the first channel to implant the anchors into the target location. The guidewire assembly includes a guidewire structure, which includes a guidewire body and a support member connected to the distal end of the guidewire body. In its natural state, the support member is triangular, and there are two support members, namely a first support member and a second support member. The first support member is located on the proximal side of the second support member, and one corner of the second support member is connected to the distal end of the guidewire body. The first support member and the second support member are spaced 7-15 mm apart along the axial direction of the guidewire body, and their projections overlap. The guidewire structure passes through the second channel.

2. The suture assembly according to claim 1, characterized in that, The guidewire assembly further includes a sheath, and the guidewire structure has a first state and a second state; In the first state, the two support members are compressed into a strip shape. The first support member is folded towards the proximal side and brought together with the guidewire body. The second support member is folded towards the distal side and parallel to the guidewire body, so that the guidewire structure in the first state can be inserted into the sheath. After the sheath is withdrawn, the guidewire structure switches from the first state to the second state; In the second state, the first support member and the second support member unfold into a triangle; The second channel passes through the guide wire body to guide the distal end of the delivery tube to the target location; When the distal end of the delivery pipe reaches the target position, the distal end of the second channel points to the central region of the first and second triangular supports.

3. The suture assembly according to claim 2, characterized in that, In the extension direction of the puncture needle, these anchors are sequentially inserted into 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 sutures. 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 sutures pass 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 exit through the puncture port.

4. The suture assembly according to claim 3, characterized in that, The guide wire assembly also includes a flow-blocking membrane, which is circular and has a through hole at its center. The flow-blocking membrane is sleeved on the outside of the guide wire body through the through hole, and is located between the first support member and the second support member.

5. The suture assembly according to claim 4, characterized in that, 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.

6. The suture assembly according to claim 5, characterized in that, 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.

7. The suture assembly according to claim 6, 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.

8. The suture assembly according to any one of claims 5-7, 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.

9. The suture assembly according to any one of claims 1-7, characterized in that, The number of the first channels is two or three, and the two or three first channels are arranged at equal angles around the axis of the conveying pipe along the axial direction of the conveying pipe; Each of the first channels corresponds to one of the puncture components; The first and second supports, which are arranged opposite to each other, constitute a support group. The number of support groups is the same as the number of the first channels. Two or three support groups are evenly arranged around the distal end of the guide wire body and correspond one-to-one with two or three second channels.

10. The suture assembly according to claim 9, characterized in that, The inclination angles of the two or three first channels are different, and the sizes of the two or three support groups are different. The smaller the inclination angle of the second channel, the smaller the size of the support component of the corresponding support group.

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