Suture needle, suture unit, and suture device

Abstract

The application provides a suture needle, a suture unit and a suture device, which can be sent to the foramen ovale position for suture through a small incision (such as entering the human body through the femoral vein of the human body), realize the foramen ovale implant-free suture, and do not need to switch different instruments for twice suture, the instrument operation is simple, and the operation time and the bleeding amount of the patient are reduced.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a suture needle, suture unit, and suture device. Background Technology

[0002] Patent foramen ovale (PFO) is a widespread congenital cardiovascular structural abnormality and has been proven to be a risk factor for various diseases, including cryptogenic stroke and migraine. Multiple randomized controlled clinical studies have shown that percutaneous catheter occlusion device placement offers greater benefits than drug therapy alone. However, current permanent metal implants carry risks such as occlusion-related complications and obstruction of transatrial septal access for left atrial interventional procedures. An ideal PFO closure method should leave no permanent foreign body, encompassing various non-permanent interventional treatments such as biodegradable PFO occluders, radiofrequency ablation and mechanical injury closure of the PFO, and percutaneous catheter suture of the PFO.

[0003] Direct suturing is the most primitive and ideal surgical method for closing defects, theoretically causing the least damage to tissues and the least impact on cardiac electrical activity. However, since PFO is located in the atrial cavity, surgical suturing methods with large trauma and high risk are limited. This patent achieves interventional suturing of PFO by designing an ingenious suturing system instrument.

[0004] Currently, there are three main methods for closure of the foramen ovale (PFO). The first method involves open surgery, where the surgeon performs manual suturing after opening the chest. Disadvantages include a long operation time, significant blood loss, substantial trauma to the patient, and a long recovery period. The second method uses a mainstream nickel-titanium metal occluder (containing a fluid-blocking membrane). This occluder has two large occlusion discs, with a smaller central section installed in the foramen ovale to close it. Disadvantages include the presence of a metal implant, causing a foreign body sensation in the patient, and the potential for complications such as thrombosis. The third method involves direct suturing using a suture device. Direct suturing is the most basic and ideal surgical method for closing the defect, theoretically minimizing tissue damage and impact on cardiac electrical activity. However, since the PFO is located within the atrial cavity, the high-risk and invasive surgical suturing methods are limited. Summary of the Invention

[0005] The purpose of this invention is to provide a suture needle, suture unit, and suture device to solve one or more problems existing in the prior art when performing occlusion of the foramen ovale.

[0006] To solve the above-mentioned technical problems, the present invention provides a suture needle, comprising: a needle tip and a needle body, wherein the needle tip is used to fix the end of the suture thread;

[0007] The needle includes a head section and a connecting section. The connecting section is detachably connected to the needle body. A limiting groove is provided between the head section and the connecting section. After the needle extends into a target object a predetermined distance, a portion of the target object is embedded in the limiting groove, thereby fixing the needle to the target object.

[0008] Optionally, in the suture needle, the target object has an inner cavity and a barb structure disposed in the inner cavity. The barb structure has a first end and a second end opposite to each other. The first end is fixed in the inner cavity, and the second end is a free end that is inclined inward relative to the first end in the inner cavity.

[0009] The outline dimension of the connecting segment is larger than that of the head segment. When the needle tip extends into the inner cavity to the predetermined distance, the distal end of the connecting segment abuts against the first end, and the proximal end of the head segment abuts against the second end, so that the barb structure remains embedded in the limiting groove.

[0010] Optionally, in the suture needle, the connecting segment has a proximal open receiving cavity, and the receiving cavity has a circumferentially recessed portion. The distal end of the needle body has an axially arranged incision and a circumferentially arranged protrusion. The incision allows the distal end of the needle body to be radially compressed and spring back. The protrusion and the recessed portion are matched. After the distal end of the needle body extends into the receiving cavity, the protrusion is embedded in the recessed portion, so that the needle tip and the needle body can be detachably connected.

[0011] The present invention also provides a suturing unit, comprising: a support member, a first suturing group and a second suturing group, wherein the first suturing group and the second suturing group are centrally symmetrically distributed about the support member, and both the first suturing group and the second suturing group include an extender arm and a suturing needle as described in any of the preceding claims;

[0012] The extender arm is rotatably mounted on the support and has a retractable position and a working position. When the extender arm is in the retractable position, it is stored in the support. When the extender arm is in the working position, it is opened at a set angle relative to the axis of the support. The suture needle is movably inserted through the support and can extend out of the support at a certain angle, so that the needle tip docks with the extender arm located in the working position.

[0013] Optionally, in the suturing unit, in the first suturing group and the second suturing group, the tilt angle direction of the suture needle when it extends out of the support is opposite to the opening angle direction of the arm when it is in the working position.

[0014] The present invention also provides a suturing device, comprising: a delivery tube, a first suture, a second suture, and a suturing unit as described above;

[0015] The delivery tube is used to deliver the suture unit to the target position; the support is connected to the distal end of the delivery tube, the suture needle passes through the delivery tube and the proximal end of the suture needle extends out of the proximal end of the delivery tube;

[0016] The first suture is fixed to the needle of the first suture group, and the second suture is fixed to the needle of the second suture group.

[0017] Optionally, in the suturing device, the suturing device further includes a soft tip connected to the distal end of the support member. The soft tip has a first axial length L1, the support member has a second axial length L2, and the length of the extender arm is L3. The following conditions are satisfied between L1, L2, and L3: L3 < L2 / 2 < L1 < L2.

[0018] Optionally, in the suturing device, the surface of the delivery tube has a hydrophilic coating, or the delivery tube is fitted with a sheath having a hydrophilic coating.

[0019] Optionally, in the suturing device, the suturing device further includes a handle connected to the proximal end of the delivery tube, the handle being used to control the movement of the suture needle and drive the abductor arm to rotate.

[0020] Optionally, in the suturing device, the handle includes a first spool and a second spool, the first spool and the second spool being used for winding the first suture and the second suture, respectively.

[0021] Optionally, in the suturing device, the handle is provided with a connecting seat, at least a portion of the outer side wall of the connecting seat is interference-fitted with the inner side wall of the handle, the distal end of the connecting seat is open for insertion of the proximal end of the delivery tube to fix the delivery tube, the proximal end of the connecting seat allows multiple components inserted inside the delivery tube to pass through, and the connecting seat is provided with a first seal for preventing blood from flowing out from the proximal end of the connecting seat.

[0022] Optionally, in the stitching device, the first seal is a sealing ring with multiple through holes.

[0023] Optionally, in the suturing device, the connecting seat includes a first part and a second part with an internal cavity in communication. The first part is for inserting the delivery tube, and at least a portion of its outer side wall is interference-fitted with the inner side wall of the handle. The proximal end of the second part allows a component inserted in the delivery tube to pass through. The second part is provided with the first seal to prevent blood from flowing out from the proximal end, and the inner diameter of the second part gradually increases from the distal end to the proximal end.

[0024] Optionally, in the suturing device, the suturing device further includes a Luer connector connected to the proximal end of the handle, the Luer connector having a second seal for preventing blood from flowing out from the proximal end of the Luer connector.

[0025] Optionally, in the suturing device, the handle includes a housing, a first drive assembly, and a second drive assembly. The housing is connected to the delivery tube along the axial direction of the delivery tube. The first drive assembly and the second drive assembly are disposed in the housing and are used to drive the suture needle to move and the abductor arm to rotate, respectively.

[0026] Optionally, in the suturing device, the first driving assembly includes a first limiting rod, a first sliding member, and a second sliding member;

[0027] The first and second sliding members extend into the housing and move the suture needles of the first and second suture groups respectively by sliding.

[0028] The first limiting rod passes through the first sliding member and the second sliding member in sequence along a direction parallel to the axis of the housing, and remains relatively fixed to the housing, so as to limit the sliding direction of the first sliding member and the second sliding member to a direction parallel to the axis of the housing.

[0029] Optionally, in the suturing device, the first driving component further includes an elastic element, which is sleeved on the first limiting member. The elastic element gradually deforms as the first sliding member moves from the starting position to the distal end, and then the first limiting member returns to the starting position by rebound.

[0030] Optionally, in the suturing device, the second drive assembly includes a second limiting rod, a third sliding member, and a fourth sliding member;

[0031] Parts of the third and fourth sliding members extend into the housing and drive the extension arms of the first and second suture groups to rotate by sliding, respectively.

[0032] The second limiting rod passes through the two second sliding members in sequence along a direction parallel to the axis of the housing, and remains relatively fixed to the housing, so as to limit the sliding direction of the two second sliding members to a direction parallel to the axis of the housing.

[0033] In summary, the suture needle, suture unit, and suture device provided by the present invention can be delivered to the foramen ovale for suturing through a small incision (such as through the femoral vein), achieving implant-free suturing of the foramen ovale, without the need to switch to different instruments for two suturing sessions, simplifying instrument operation, reducing operation time and patient bleeding. Attached Figure Description

[0034] Figure 1 This is a schematic diagram showing the state of the needle tip when it is connected to the extension arm and the needle body in an embodiment of the present invention;

[0035] Figure 2 This is a schematic diagram showing the state when the needle body and needle tip are separated in an embodiment of the present invention;

[0036] Figure 3 This is a schematic diagram of the head section structure of the suture device provided in an embodiment of the present invention;

[0037] Figure 4 This is a schematic diagram of the overall structure of the suturing device provided in an embodiment of the present invention;

[0038] Figure 5 This is a schematic diagram showing that the surface of the delivery pipe has a hydrophilic coating in an embodiment of the present invention;

[0039] Figure 6 This is a schematic diagram of a sheath with a hydrophilic coating surrounding the delivery pipe in an embodiment of the present invention;

[0040] Figure 7 This is a schematic diagram of the tail structure of the suturing device provided in an embodiment of the present invention;

[0041] Figure 8 This is a schematic diagram of the overall structure of the connector in an embodiment of the present invention;

[0042] Figure 9 This is a schematic diagram of the internal structure of the connector in an embodiment of the present invention;

[0043] Figures 10-15 This is a schematic diagram showing the state corresponding to each suturing step when suturing the foramen ovale using the suturing device provided in the embodiments of the present invention;

[0044] The labels in the accompanying drawings are explained as follows:

[0045] 1-Support component; 3-Push component; 4-Conveyor pipe; 5-Handle; 6-Connector; 7-Luer connector; 8-Installation pipe; 9-Soft head; 10-Rotating shaft;

[0046] 21-Arm extension; 22-Suture needle; 23-Suture thread;

[0047] 221 - Needle tip; 222 - Needle body;

[0048] 211-Connecting sleeve;

[0049] 2111 - Barbed structure;

[0050] a - First end; b - Second end;

[0051] 2211-Connecting section; 2212-Head section; 2213-Limiting groove;

[0052] 2220 - Depression; 2221 - Cut; 2222 - Protrusion;

[0053] 41-Hydrophilic coating; 42-Sheath;

[0054] 61 - First part; 62 - Second part; 63 - First seal;

[0055] 71 - Second seal;

[0056] 50 - Housing; 51 - First drive assembly; 52 - Second drive assembly; 53 - First coil; 54 - Second coil;

[0057] 511-First sliding member; 512-Second sliding member; 513-First limiting rod; 514-Elastic member;

[0058] 51a - Control unit; 51b - Support unit;

[0059] 521 - Third sliding member; 522 - Fourth sliding member; 523 - Second limiting rod;

[0060] 501 - Protrusion; 502 - Column;

[0061] 100-guidewire;

[0062] 21a - First abductor arm; 22a - First suture needle; 23a - First suture thread;

[0063] 21b - Second abductor arm; 22b - Second suture needle; 23a - Second suture thread. Detailed Implementation

[0064] To make the objectives, advantages, and features of the present invention clearer, the present invention will be described in detail below with reference to the accompanying drawings and specific embodiments. It should be noted that the drawings are all in a very simplified form and are not drawn to scale, and are only used to facilitate and clarify the illustration of the embodiments of the present invention. Furthermore, the structures shown in the drawings are often part of the actual structures. In particular, different figures may have different emphases and sometimes different scales. As used in this invention, the singular forms “a,” “an,” and “the” include plural objects; the term “or” is generally used to include the meaning of “and / or”; the term “a number” is generally used to include the meaning of “at least one”; the term “at least two” is generally used to include the meaning of “two or more”; furthermore, the terms “first,” “second,” and “third” are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of indicated technical features. Therefore, features defined with "first," "second," and "third" may explicitly or implicitly include one or at least two of those features. "One end" and "the other end," as well as "proximal" and "distal," generally refer to two corresponding parts, including not only the endpoints. The terms "proximal" and "distal" are defined herein with respect to an interventional system having one end for insertion into the human body (e.g., a bendable catheter) and a manipulator extending outside the body (e.g., a bendable handle). The term "proximal" refers to the position of the element closer to the manipulator extending outside the interventional system, and the term "distal" refers to the position of the element closer to the interventional system in the human body and therefore further away from the manipulator. Optionally, in manual or hand-operated applications, the terms "proximal" and "distal" are defined herein with respect to the operator, such as a surgeon or clinician. The term "proximal" refers to the position of the element closer to the operator, and the term "distal" refers to the position of the element closer to the interventional system and therefore further away from the operator. Furthermore, the terms "installed," "connected," and "attached," as used in this invention, and the term "set" on one element from another, should be interpreted broadly. They generally only indicate a connection, coupling, cooperation, or transmission relationship between the two elements, which can be direct or indirect through an intermediate element. They should not be construed as indicating or implying a spatial relationship between the two elements, meaning one element can be located inside, outside, above, below, or to one side of another element, unless otherwise explicitly stated. Those skilled in the art can understand the specific meaning of these terms in this invention based on the specific circumstances. Additionally, directional terms such as above, below, up, down, upward, downward, left, and right are used relative to exemplary embodiments as shown in the figures, with upward or upper directions pointing towards the top of the corresponding figure, and downward or lower directions pointing towards the bottom of the corresponding figure.

[0065] Please see Figure 1 and Figure 2 This invention provides a suture needle 22, which includes a needle tip 221 and a needle body 222. The needle tip 221 is used to fix the tip of a suture 23. There are various ways to fix the suture 23 to the needle tip 221. For example, the tip of the suture 23 can be directly glued to the needle tip 221, or the needle tip 221 is provided with a through hole, and the tip of the suture 23 is fixed by knotting or other means after passing through the through hole.

[0066] The needle 221 includes a head section 2212 and a connecting section 2211. The connecting section 2211 is detachably connected to the needle body 222. A limiting groove 2213 is provided between the head section 2212 and the connecting section 2211. After the needle 221 extends a predetermined distance into a target object, a portion of the target object is embedded in the limiting groove 2213, thereby fixing the needle 221 to the target object.

[0067] Preferably, the target object has an inner cavity and a barb structure 2111 disposed within the inner cavity. The barb structure 2111 has a first end a and a second end b, the first end a being fixed within the inner cavity, and the second end b being a free end that is inclined inward relative to the first end a within the inner cavity. The barb structure 2111 can be formed by providing a connecting sleeve 211 within the inner cavity, with a portion of the connecting sleeve 211 curving inward. The outline dimension of the connecting segment 2211 is larger than the outline dimension of the head segment 2212. When the needle tip 221 extends into the inner cavity to the predetermined distance, the distal end of the connecting segment 2211 abuts against the first end a, and the proximal end of the head segment 2212 abuts against the second end b, so that the barb structure 2111 remains embedded within the limiting groove 2213.

[0068] In the specific application scenario of this embodiment, the target object can be understood as the extender arm 21 used to engage with the suture needle 22, and a portion of the target object can be understood as the barb structure 2111 within the extender arm 21. Therefore, in the further description of the suture needle 22 below, for the sake of convenience, the target object is directly replaced by the extender arm 21, and a detailed description of the extender arm 21 is provided below. It should be understood that in other application scenarios, the target object can also be a structure that needs to be used in conjunction with the suture needle 22 for suturing.

[0069] Due to the presence of the barb structure 2111 and the limiting groove 2213, the needle 221 can be inserted into the extender arm 21 and remain fixedly connected to the extender arm 21 at all times, preventing it from falling out of the extender arm 21 and causing the risk of complications. This preferred embodiment facilitates the anchoring of the needle 221 in the extender arm 21 and facilitates the fixed connection between the needle and the extender arm 21. Other embodiments that enable docking between the suture needle 22 and the extender arm 21 and prevent the needle 221 from falling out of the extender arm 21 are also within the scope of protection of this application.

[0070] In this embodiment, the connecting segment 2211 has a accommodating cavity with a proximal opening, and a recessed portion 2220 is provided circumferentially inside the accommodating cavity. The distal end of the needle body 222 has an axially arranged cutout 2221 and a circumferentially arranged protrusion 2222. The cutout 2221 allows the distal end of the needle body 222 to be radially compressed and springback. The protrusion 2222 and the recessed portion 2220 are matched. After the distal end of the needle body 222 extends into the accommodating cavity, the protrusion 2222 is embedded in the recessed portion 2220, so that the needle tip 221 and the needle body 222 can be detachably connected.

[0071] Since the needle body 222 is separated from the needle tip 221, it can be withdrawn after the connection with the needle tip 221 is released. Since the tip of the suture 23 is fixed to the needle tip 221, the needle tip 221 is then withdrawn from the body along with the extension arm 21, thus completing one suture.

[0072] As mentioned above, in order to embed the barb structure 2111 into the limiting groove 2213, the connecting segment 2211 that abuts against the first end a has a larger profile size than the head segment 2212 that abuts against the second end b. Therefore, the connecting segment 2211 has a relatively large size to set the receiving cavity. Thus, it can be understood that in this embodiment, the needle tip 221 of the suture needle 22 adopts a structure design with a small head and a large tail, and the needle body 222 adopts a compressible structure design. This is beneficial for the fixed connection between the needle tip 221 and the extension arm 21, and also for the separable connection between the needle tip 221 and the needle body 222.

[0073] like Figure 3 As shown, this embodiment of the invention also provides a suturing unit, which includes: a support member 1, a first suturing group and a second suturing group. The first suturing group and the second suturing group are centrally symmetrically distributed about the support member 1. Both the first suturing group and the second suturing group include an extender arm 21 and a suturing needle 22 as described in this embodiment.

[0074] The extender arm 21 is rotatably mounted on the support member 1, and the extender arm 21 has a retracted position and a working position. When in the retracted position, the extender arm 21 is retracted into the support member 1, and when in the working position, the extender arm 21 is opened at a set angle relative to the axis of the support member 1. The suture needle 22 is movably inserted into the support member 1 and can extend out of the support member 1 at a certain angle, so that the needle tip 221 engages with the extender arm 21 located in the working position. In this embodiment, the extender arm 21 and the support member 1 are specifically connected by a rotating shaft 10, which is arranged perpendicular to the axial direction of the support member 1, so that the extender arm 21 opens and closes relative to the axis of the support member 1.

[0075] The suturing unit provided in this embodiment can be delivered to the foramen ovale for suturing through a small incision (such as through the femoral vein). Since the first suturing group and the second suturing group can suture the two sides of the foramen ovale respectively, there is no need to switch to different instruments for two suturing sessions. Therefore, the operation is simple, the operation time is controlled, and there is no large amount of bleeding.

[0076] Preferably, in the first and second suture groups, the tilt angle of the suture needle 22 extending beyond the support member 1 is opposite to the opening angle of the extended arm 21 in the working position. Here, the tilt angle can be understood as the opening direction of the angle formed by the suture needle 22 gradually deviating from the axis of the support member 1 towards the distal end, and the opening angle can be understood as the opening direction of the angle formed between the extended arm 21 and the axis of the support member 1 in the working position. If one of the tilt angle and the opening angle is towards the proximal end, then the other is towards the distal end. Thus, the suture unit has a needle direction that matches the opening orientation of the oval aperture, facilitating suture placement.

[0077] Please see Figure 4 and combined Figure 3 This invention also provides a suturing device, which includes a delivery tube 4, a suture 23, and a suturing unit as described in this embodiment. The delivery tube 4 is used to deliver the suturing unit to a target position. A support member 1 is connected to the distal end of the delivery tube 4, and a suture needle 22 passes through the delivery tube 4 with its proximal end extending beyond the proximal end of the delivery tube 4. The first suturing group and the second suturing group each guide a suture 23 to complete one suture. For details, please refer to... Figures 11-14The suturing device includes a first suture 23a and a second suture 23b; the tip of the first suture 23a is fixed to the needle 221 of the first suture group, and the tip of the second suture 23b is fixed to the needle 221 of the second suture group.

[0078] Preferably, the conveying pipe 4 and the support member 1 are connected by a fusion method, and as shown in the figure Figure 5 As shown, the surface of the conveying pipe 4 has a hydrophilic coating, or as... Figure 6 As shown, the conveying pipe 4 is fitted with a sheath tube with a hydrophilic coating, which can increase the smoothness of the conveying system and reduce the resistance during the propulsion process.

[0079] Please continue reading Figure 4 The suturing device provided in this embodiment may further include a handle 5, which is connected to the proximal end of the delivery tube 4. The handle 5 is used to control the movement of the suture needle 22 and drive the abductor arm 21 to rotate. The suture needle 22 is movably inserted through the delivery tube 4, with its distal end extending out of the support member 1 and docking with the corresponding abductor arm 21, and its proximal end connected to the handle 5. The handle 5 can be connected to the abductor arm 21 via a pusher 3. By controlling the movement of the pusher 3, the abductor arm 21 can be driven to rotate. Specifically, the abductor arms 21 of the first suture group and the second suture group are connected to the handle 5 via two different pushers 3. Each pusher 3 is movably inserted through the delivery tube 4, with its distal end connected to the abductor arm 21 and its proximal end connected to the handle 5.

[0080] Preferably, the delivery tube 4 is a multi-cavity tube, with different suture needles 22 and different pushers 3 passing through different cavities in the delivery tube 4 to avoid mutual interference during movement.

[0081] For a better option, please refer to Figure 7 The handle 5 is provided with a connecting seat 6. At least part of the outer side wall of the connecting seat 6 is press-fitted with the inner side wall of the handle 5. The distal end of the connecting seat 6 is open, allowing the proximal end of the delivery tube 4 to be inserted to fix the delivery tube 4. The proximal end of the connecting seat 6 allows components passing through the delivery tube 4 to exit. The components passing through the delivery tube 4 include, as described above in this embodiment, the suture needle 22, suture 23, pusher 3, and guide wire 100, etc., as described below. Figure 8 As shown, the proximal end of the connecting seat 6 can be a base with multiple dispersed through holes. This base allows components to pass through while guiding them to connect to the corresponding drive assembly from different positions. A description of the drive assembly is provided below. Furthermore, as... Figure 9As shown, the connecting seat 6 is provided with a first sealing element 63, which is used to prevent blood from flowing out from the proximal end of the connecting seat 6. The first sealing element 63 forms the base of the connecting seat 6, or the first sealing element 63 has a plurality of through holes corresponding to the through holes on the base, for each component to pass through. The first sealing element 63 is preferably a sealing ring, which has a plurality of through holes for each component to pass through. The through holes of the sealing ring are in a self-closing state when no component passes through, thus meeting the need for guide wire replacement in the interventional state of the suture device. Since there is an interference fit between the connecting seat 6 and the inner sidewall of the handle 5, blood will not flow into the handle 5 from between the two. And since the proximal end of the connecting seat 6 is sealed, blood will not flow out from the proximal end of the connecting seat 6 or the amount of blood flowing out is very small, thus improving the seal.

[0082] Furthermore, the connecting seat 6 includes a first portion 61 and a second portion 62 with interconnected internal cavities. The first portion 61 is used for insertion of the delivery tube 4, and at least part of its outer side wall has an interference fit with the inner side wall of the handle 5. The proximal end of the second portion 62 allows components inserted within the delivery tube 4 to pass through. Correspondingly, the proximal end of the second portion 62 can be designed as a base with multiple dispersed through holes as described above. The second portion 62 is provided with the first sealing element 63 to prevent blood from flowing out from the proximal end, and the inner diameter of the second portion 62 gradually increases from the distal end to the proximal end. The first portion 61 can be designed with a uniform outer diameter. To achieve an interference fit with the inner side wall of the handle 5, a protrusion 501 can be designed on the inner side wall of the handle 5 to match the outer diameter of the first portion 61. The inner diameter of the second portion 62 increases sequentially, so that multiple components within the delivery tube 4 have sufficient passage space when passing through the proximal end of the second portion 62 without interfering with each other.

[0083] The suturing device provided in this embodiment can be positioned under the guidance of the sheath and guidewire. Please continue reading. Figure 4 and combined Figure 7 The suturing device further includes a Luer connector 7, which is connected to the proximal end of the handle 5. The Luer connector 7 has a second seal 71, which prevents blood from flowing out from the proximal end of the Luer connector 7. The Luer connector 7 and the second seal 71 are used to allow a guidewire to pass through from the proximal end. The second seal 71 is preferably a sealing ring with a through-hole for the guidewire to pass through. This through-hole is in a self-closing state when the guidewire is not passing through, thus meeting the need for guidewire replacement during intervention.

[0084] The handle 5 is also provided with an installation tube 8. The distal end of the installation tube 8 is connected to the delivery tube 4, and the proximal end is connected to the Luer connector 7. When the guide wire 100 is assembled with the suturing device, it enters from the distal end of the suturing device, and then passes through the support member 1, the delivery tube 4, and the installation tube 8 in sequence before exiting from the Luer connector 7. When the delivery tube 4 adopts a multi-cavity design, the channel for the guide wire 100 to pass through can be designed to be located in its axial direction.

[0085] To prevent tissue damage after the suturing device is inserted into the human body, the suturing device preferably includes a soft tip 9, which is axially connected to the distal end of the support member 1. When the guide wire 100 is assembled with the suturing device, it passes through the soft tip 9 and exits through the Luer connector 7. The soft tip 9 has a first axial length L1, the support member 1 has a second axial length L2, and the extension arm 21 has a length L3. Preferably, L1, L2, and L3 satisfy the following relationship: L3 < L2 / 2 < L1 < L2. This design minimizes the length of the distal portion of the suturing device, reducing the risk of puncture into the inner wall of the heart during suturing.

[0086] Please see Figure 4 The handle 5 includes a housing 50, a first drive assembly 51, and a second drive assembly 52. ​​The housing 50 is connected to the delivery pipe 4 along the axial direction of the delivery pipe 4. The first drive assembly 51 and the second drive assembly 52 are disposed in the housing 50 and are used to drive the suture needle 22 and the extension arm 21 to move, respectively.

[0087] For further details, please see Figure 7The first driving assembly 51 includes a first slider 511 and a second slider 512; portions of the first slider 511 and the second slider 512 extend into the housing 50 and are respectively connected to the proximal ends of the suture needles 22 of the first suture group and the second suture group, so as to drive the corresponding suture needles 22 to move by sliding. Specifically, a through groove penetrating the side wall of the housing 50 can be formed on the housing 50, and the extending direction of the through groove is parallel to the axis of the housing 50, so as to initially define the sliding direction of the first slider 511 and the second slider 512 as a direction parallel to the axis of the housing 50. To further control the accuracy of the sliding direction of the first sliding member 511 and the second sliding member 512, preferably, the first driving assembly 51 further includes a first limiting rod 513. The first limiting rod 513 passes sequentially through the first sliding member 511 and the second sliding member 512 in a direction parallel to the axis of the housing 50, and remains relatively fixed to the housing 50, so as to further limit the sliding direction of the first sliding member 511 and the second sliding member 512 to be parallel to the axis of the housing 50. The two ends of the first limiting rod 513 can be fixed by two protruding pillars 502 on the inner sidewall of the housing 50.

[0088] Specifically, both the first sliding member 511 and the second sliding member 512 include a control part 51a and a support part 51b. In both the first sliding member 511 and the second sliding member 512, the control part 51a is located outside the housing 50. One end of the support part 51b is perpendicularly connected to the control part 51a, and the other end extends into the housing 50 and connects to the proximal end of the suture needle 22. When the first limiting rod 513 passes through the first sliding member 511 and the second sliding member 512, it passes through the support part 51b in a direction perpendicular to the support part 51b.

[0089] Further preferably, the first driving component 51 also includes an elastic element 514, such as a spring, which is sleeved on the first limiting rod 513. The elastic element 514 gradually deforms as the first sliding member 511 moves from the starting position to the distal end, and then drives the first limiting rod 513 back to the starting position by rebounding.

[0090] Similarly, the second drive assembly 52 includes a second limiting rod 523, a third sliding member 521, and a fourth sliding member 522. Parts of the third sliding member 521 and the fourth sliding member 522 extend into the housing 50 and are respectively connected to the proximal ends of the two push members 3, so as to drive the extension arms 21 of the first suture group and the second suture group to rotate via sliding. The second limiting rod 523 passes sequentially through the third sliding member 521 and the fourth sliding member 522 in a direction parallel to the axis of the housing 50, and remains relatively fixed to the housing 50, thereby limiting the sliding direction of the third sliding member 521 and the fourth sliding member 522 to be parallel to the axis of the housing 50. The specific fixing method / structural design of the second limiting rod 523 can be similar to that of the first limiting rod 513, and the specific fixing method / structural design of the third sliding member 521 / the fourth sliding member 522 can be similar to that of the first sliding member 511 / the second sliding member 512, and will not be described in detail here.

[0091] Preferably, the handle 5 includes a first thread reel 53 and a second thread reel 54, the first thread reel 53 and the second thread reel 54 being used for winding the first suture 23a and the second suture 23b respectively, which can prevent the first suture 23a and the second suture 23b from interfering with each other during use.

[0092] The following describes the suturing process of suturing the foramen ovale using the suturing device provided in the embodiments of the present invention. For ease of description, the first suturing group and the second suturing group are distinguished as follows: The first suturing group includes a first suture needle 22a and a first abductor arm 21a; the second suturing group includes a second suture needle 22b and a second abductor arm 21b; the first sliding member 511 is connected to the proximal end of the first suture needle 22a; the second sliding member 512 is connected to the proximal end of the second suture needle 22b; the third sliding member 521 is connected to the first abductor arm 21a via a pusher 3; and the fourth sliding member 522 is connected to the second abductor arm 21b via another pusher 3. The two sides of the foramen ovale are distinguished as the first side and the second side. The suturing process of suturing the foramen ovale using the suturing device provided in the embodiments of the present invention is as follows:

[0093] (1) such as Figure 10 As shown, the tip 2212 of the suture device is inserted into the foramen ovale of the heart via a sheath (not shown) and guide wire 100 puncture.

[0094] (2) such as Figure 11As shown, the third slider 521 is pushed to move to the distal end, so that the first extension arm 21a opens to the working position, and the first slider 511 is pushed to move to the distal end, so that the first suture needle 22a passes through the first side of the oval aperture. After the first suture needle 22a passes through the first side of the oval aperture, its needle tip 221 is anchored by the first extension arm 21a, so that the first suture 23a remains passing through the first side of the oval aperture.

[0095] (3) such as Figure 12 As shown, the first slider 511 is pushed to move proximally to retract the needle body 222 of the first suture needle 22a, and the third slider 521 is pushed to move proximally so that the first extension arm 21a carries the needle tip 221 of the first suture needle 22a back to the retrieval position;

[0096] (4) such as Figure 13 As shown, the fourth slider 522 is pushed to move distally, causing the second extension arm 21b to open to the working position, and the second slider 512 is pushed to move distally, causing the second suture needle 22b to pass through the second side of the oval aperture. After the second suture needle 22b passes through the second side of the oval aperture, its needle tip 221 is anchored by the second extension arm 21b, so that the second suture 23b remains passing through the second side of the oval aperture.

[0097] (5) such as Figure 14 As shown, the second slider 512 is pushed to move proximally to retract the needle body 222 of the second suture needle 22b, and the fourth slider 522 is pushed to move proximally so that the second extension arm 21b carries the needle tip 221 of the second suture needle 22b back to the retraction position;

[0098] (6) For example Figure 15 As shown, the suturing device is removed from the body, the first suture 23a and the second suture 23b are knotted or tightened, the excess part of the suture 23 ends is cut off, and the ovoid foramen suture is finally completed.

[0099] As can be seen from the above suturing process, the suturing device provided in this embodiment of the invention can suture two stitches with a single input, reducing operation time and patient bleeding. In addition, the suturing device provided in this embodiment of the invention can suture in two directions, which can perfectly match the structural requirements on both sides of the foramen ovale, and can ensure that the suture needle will not be inserted into empty spaces.

[0100] In summary, the suture needle, suture unit, and suture device provided by the present invention can be delivered to the foramen ovale for suturing through a small incision (such as through the femoral vein), achieving implant-free suturing of the foramen ovale, without the need to switch to different instruments for two suturing sessions, simplifying instrument operation, reducing operation time and patient bleeding.

[0101] It should be further noted that although the suturing device provided by the present invention is designed for suturing the foramen ovale, it should be understood that the suturing device provided by the present invention can also be applied to other scenarios that require suturing. Its application in sealing the foramen ovale does not constitute a limitation on the suturing device provided by the present invention.

[0102] Furthermore, it should be understood that although the present invention has been disclosed above with reference to preferred embodiments, these embodiments are not intended to limit the present invention. For any person skilled in the art, many possible variations and modifications can be made to the technical solutions of the present invention based on the disclosed technical content, or equivalent embodiments with equivalent changes, without departing from the scope of the present invention. Therefore, any simple modifications, equivalent changes, and modifications made to the above embodiments based on the technical essence of the present invention without departing from the content of the present invention shall still fall within the scope of protection of the present invention.

Claims

1. A suturing device, characterized in that, include: The suture unit comprises a delivery tube, a first suture, a second suture, and a suture unit; the delivery tube is used to deliver the suture unit to a target position; the suture unit includes a support member, a first suture group, and a second suture group, the first suture group and the second suture group being centrally symmetrically distributed about the support member, and both the first suture group and the second suture group including an extender arm and a suture needle; The suture needle includes: a needle tip and a needle body, wherein the needle tip is used to fix the tip of the suture thread; The needle includes a head section and a connecting section. The connecting section is detachably connected to the needle body. A limiting groove is provided between the head section and the connecting section. After the needle extends into a target object a predetermined distance, a portion of the target object is embedded in the limiting groove, thereby fixing the needle to the target object. The target object is a structure used in conjunction with the suture needle for suturing, including the extendable arm. The extender arm is rotatably mounted on the support and has a retractable position and a working position. When the extender arm is in the retractable position, it is stored in the support. When the extender arm is in the working position, it is opened at a set angle relative to the axis of the support. The suture needle is movably inserted through the support and can extend out of the support at a certain angle, so that the needle tip docks with the extender arm located in the working position. The support is connected to the distal end of the delivery tube, and the suture needle is inserted into the delivery tube with its proximal end extending beyond the proximal end of the delivery tube. The first suture is fixed to the needle of the first suture group, and the second suture is fixed to the needle of the second suture group; The suturing device further includes a handle connected to the proximal end of the delivery tube. The handle is used to control the movement of the suture needle and drive the abductor arm to rotate. The handle includes a first suture reel and a second suture reel, which are used for winding the first suture and the second suture, respectively.

2. The suturing device as claimed in claim 1, characterized in that, The target object has an inner cavity and a barbed structure disposed in the inner cavity. The barbed structure has a first end and a second end opposite to each other. The first end is fixed in the inner cavity, and the second end is a free end that is inclined inward relative to the first end in the inner cavity. The outline dimension of the connecting segment is larger than that of the head segment. When the needle tip extends into the inner cavity to the predetermined distance, the distal end of the connecting segment abuts against the first end, and the proximal end of the head segment abuts against the second end, so that the barb structure remains embedded in the limiting groove.

3. The suturing device as described in claim 1, characterized in that, The connecting section has a accommodating cavity that is open at its proximal end, and the accommodating cavity has a recessed portion along the circumferential direction. The distal end of the needle body has an axially arranged cut and a circumferentially arranged protrusion. The cut allows the distal end of the needle body to be radially compressed and spring back. The protrusion and the recessed portion are matched. After the distal end of the needle body extends into the accommodating cavity, the protrusion is embedded in the recessed portion, so that the needle tip and the needle body can be detachably connected.

4. The suturing device as claimed in claim 1, characterized in that, In the first suture group and the second suture group, the tilt angle of the suture needle when it extends out of the support is opposite to the opening angle of the arm when it is in the working position.

5. The suturing device as claimed in claim 1, characterized in that, The suture device further includes a soft tip connected to the distal end of the support member. The soft tip has a first axial length L1, the support member has a second axial length L2, and the length of the extender arm is L3. The following conditions are satisfied between L1, L2, and L3: L3 < L2 / 2 < L1 < L2.

6. The suturing device as claimed in claim 1, characterized in that, The surface of the delivery pipe has a hydrophilic coating, or the delivery pipe is fitted with a sheath having a hydrophilic coating.

7. The suturing device as claimed in claim 1, characterized in that, The handle is provided with a connector, at least a portion of the outer side wall of the connector is press-fitted with the inner side wall of the handle, the distal end of the connector is open for insertion of the proximal end of the delivery tube to fix the delivery tube, the proximal end of the connector allows multiple components inserted inside the delivery tube to pass through, and the connector is provided with a first seal to prevent blood from flowing out from the proximal end of the connector.

8. The suturing device as claimed in claim 7, characterized in that, The first sealing element is a sealing ring with multiple through holes.

9. The suturing device as claimed in claim 7, characterized in that, The connector includes a first part and a second part with an internal cavity. The first part is for inserting the delivery tube, and at least part of its outer side wall is press-fitted with the inner side wall of the handle. The proximal end of the second part allows a component inserted in the delivery tube to pass through. The second part is provided with the first seal to prevent blood from flowing out from the proximal end, and the inner diameter of the second part gradually increases from the distal end to the proximal end.

10. The suturing device as claimed in claim 1, characterized in that, The suturing device also includes a Luer connector connected to the proximal end of the handle, and the Luer connector has a second seal for preventing blood from flowing out from the proximal end of the Luer connector.

11. The suturing device as claimed in claim 1, characterized in that, The handle includes a housing, a first drive assembly, and a second drive assembly. The housing is connected to the delivery tube along the axial direction of the delivery tube. The first drive assembly and the second drive assembly are disposed in the housing and are used to drive the suture needle to move and the arm to rotate, respectively.

12. The suturing device as claimed in claim 11, characterized in that, The first driving component includes a first limiting rod, a first sliding member, and a second sliding member; The first and second sliding members extend into the housing and move the suture needles of the first and second suture groups respectively by sliding. The first limiting rod passes through the first sliding member and the second sliding member in sequence along a direction parallel to the axis of the housing, and remains relatively fixed to the housing, so as to limit the sliding direction of the first sliding member and the second sliding member to a direction parallel to the axis of the housing.

13. The suturing device as claimed in claim 12, characterized in that, The first driving component further includes an elastic element, which is sleeved on the first limiting element. The elastic element gradually deforms as the first sliding element moves from the starting position to the distal end, and then the first limiting element is driven back to the starting position by the rebound.

14. The suturing device as claimed in claim 12, characterized in that, The second drive assembly includes a second limiting rod, a third sliding member, and a fourth sliding member; Parts of the third and fourth sliding members extend into the housing and drive the extension arms of the first and second suture groups to rotate by sliding, respectively. The second limiting rod passes through the two second sliding members in sequence along a direction parallel to the axis of the housing, and remains relatively fixed to the housing, so as to limit the sliding direction of the two second sliding members to a direction parallel to the axis of the housing.

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