A suture head for patent foramen ovale closure surgery

Abstract

This invention provides a suture head for patent foramen ovale (PFO) closure surgery, belonging to the field of PFO closure technology. It solves the problem of increased complications associated with current closure methods. Two symmetrical insertion channels are opened at both ends of the lever, each containing a suture buckle connected by a connecting line with a pull thread at its center. Two needle tubes are symmetrically positioned on both sides inside the outer tube, each containing a push rod and an insertion tip. The ends of the needle tubes furthest from the insertion tips are connected to a first push rod for pushing the two needle tubes into the two insertion channels. The two push rods are connected to a second push rod for driving them to extend out of the two needle tubes. After the needle tubes pass through the insertion channels, the suture buckles are located within the needle tube lumens. This invention offers advantages such as minimally invasive closure of the PFO and reduced risk of complications.

Description

Technical Field

[0001] This invention belongs to the field of patent foramen ovale closure technology, and specifically relates to a suture head for patent foramen ovale closure surgery. Background Technology

[0002] The foramen ovale (PFO) typically closes within the first year of life. If it remains open in children older than three years, it is called patent foramen ovale (PFO). In adults, 20%–25% of PFOs are incompletely closed. PFO is currently the most common congenital heart defect in adults. Recent studies have shown a close link between PFO and unexplained stroke. Treating the underlying cause and closing open PFOs in high-risk individuals may reduce the incidence of these conditions. Furthermore, PFO has been associated with decompression sickness and migraines; closing the foramen ovale may be beneficial for these patients.

[0003] Currently, most procedures use occlusion surgery, which involves placing an occlusion device on each side of the foramen ovale. The occlusion devices are relatively large, and due to the complex structure inside the heart, placing the occluder inside the heart is not easy for many patients to accept, which may increase the risk of complications in the short and long term. Summary of the Invention

[0004] The purpose of this invention is to address the aforementioned problems in the prior art by providing a suture head for suturing patent foramen ovale.

[0005] The objective of this invention can be achieved through the following technical solution: A suture head for patent foramen ovale closure surgery, characterized in that it comprises an outer tube, a swing rod, and two needle tubes. A mounting bracket is provided at the first end of the outer tube. The swing rod is rotatably mounted on the mounting bracket. A driving rod is provided inside the outer tube, which is used by a person to pull the swing rod away from the end, thereby rotating the swing rod. Two through-channels are symmetrically opened at both ends of the swing rod. A suture buckle is provided in each of the two through-channels. The two suture buckles are connected by a connecting line, and a pull wire is connected to the middle of the connecting line. Two needle tubes are symmetrically arranged on both sides inside the outer tube. A push rod is provided in the lumen of each of the two needle tubes. Each tube is equipped with an insertion tip. The ends of the two needle tubes away from the insertion tips are connected to a first push rod for pushing the two needle tubes into the two insertion channels respectively. The two push rods are connected to a second push rod for driving the two push rods to extend out of the two needle tubes respectively. After the needle tube passes through the insertion channel, the suture buckle is located in the lumen of the needle tube. The end of the drive rod near the swing rod is provided with a rotating block. The swing rod near the perforation is provided with a rotating groove for accommodating the rotating block. A gap is left between the outer wall of the suture buckle and the side wall of the insertion channel for the tube wall to pass through. Both side walls of the two needle tubes are provided with clearance grooves that communicate with the lumen of the needle tube.

[0006] The working principle of this invention: The drive rod, the first push rod, the second push rod, and the pull wire all have operating ends extending from the second end of the outer tube. In use, the outer tube is inserted through the catheter insertion sheath and advanced through the patient's groin to the atrium. During this process, the pendulum and the outer tube are aligned in a straight line. Then, using angiography, the location is determined to be at the foramen ovale. The operator first pulls the drive rod to rotate and unfold the pendulum, aligning the two ends of the pendulum with the septa on both sides of the foramen ovale. Then, the operator pushes the first push rod, causing two needles to extend from the outer tube, pass through the insertion channel, and pierce the septa on both sides of the foramen ovale. Then, push the second push rod to push the two pushers until the two pushers push the two suture knots out of the two needle tubes respectively. Then, use the first and second push rods to pull the pushers and needle tubes back into the outer tube. In this way, the two suture knots are located on the other side of the septum. Pulling the suture will bring the two suture knots together and cause the septum on both sides of the foramen ovale to close. The connection between the connecting line and the suture is pre-knotted. After pulling the two suture knots together, the knot is completed. Finally, the suture is cut with a suture cutter. This achieves minimally invasive suturing of the patent foramen ovale, reduces the risk of complications, and is practical and reliable.

[0007] In the aforementioned suture head for patent foramen ovale closure surgery, the mounting frame includes two mounting plates. Each mounting plate has a rotating shaft at its end away from the outer tube. The middle of the swing arm has docking holes on both sides for docking the rotating shafts. The docking holes and rotating shafts correspond one-to-one. Limiting rods are provided on both side walls of the swing arm. Limiters are provided on both rotating shafts. Each of the two limiters has an annular groove on the side facing the swing arm for inserting the limiting rod. Protrusions are provided on both side walls of the annular groove to form a limiting opening.

[0008] In the suture head for the aforementioned patent foramen ovale suture surgery, the drive rod has a receiving channel at the end furthest from the rotating block. A track block is located near the rotating block within the receiving channel. The track block has two movable channels that are used to receive two needle tubes respectively. Both sides of the drive rod have needle exit openings that communicate with the receiving channels. Both sides of the track block have needle exit holes, and both sides of the track block are respectively engaged in the two needle exit openings. The two needle exit holes communicate with the two movable channels respectively. Both sides of the outer tube have exposure grooves that allow the two needle exit holes to be exposed.

[0009] In the suture head for the above-mentioned patent foramen ovale suture surgery, both needle tubes and both push rods are made of shape memory alloy, and both needle outlets are provided with guide arc surfaces on the side near the swing rod.

[0010] In the suture head for the above-mentioned patent foramen ovale suture surgery, the first push rod is located in the receiving channel and fixed to the end of the needle tube away from the insertion tip. The first push rod is provided with a mounting channel for receiving the second push rod. The end of the second push rod near the needle tube is provided with two push posts, and the two push posts are respectively fixedly connected to two push rods.

[0011] In the suture head for the above-mentioned patent foramen ovale suture surgery, a suture groove is provided on one side of the swing rod, and the two ends of the suture groove are respectively connected to two through channels. A through hole connected to the suture groove is provided on the other side of the swing rod. The through hole is used for the pull wire to pass through. The second push rod and the track block are both provided with a pull channel for the pull wire to pass through.

[0012] In the suture head for the above-mentioned patent foramen ovale suture surgery, two docking blocks are provided on the side walls of the two passage channels, and two docking grooves are provided on the outer side walls of the two suture buckles.

[0013] Compared with existing technologies, the present invention has the advantage of achieving minimally invasive suturing of patent foramen ovale and reducing the risk of complications. Attached Figure Description

[0014] Figure 1 This is a schematic diagram of the structure of the present invention.

[0015] Figure 2 This is a schematic diagram of the pendulum in its unfolded state in this invention.

[0016] Figure 3 This is a schematic diagram of the structure of the present invention.

[0017] Figure 4 This is a schematic diagram of the hidden outer tube structure in this invention.

[0018] Figure 5 This is a schematic diagram of the structure of the hidden outer tube and drive rod in this invention.

[0019] Figure 6 This is a schematic diagram of the structure of the concealed outer tube, drive rod, first push rod, and one of the limiters in this invention.

[0020] Figure 7 This is an enlarged structural diagram of part A in this invention.

[0021] Figure 8 This is a schematic diagram of the pendulum in its unfolded state in this invention.

[0022] Figure 9 This is a schematic diagram of the limiter in this invention.

[0023] Figure 10 This is a schematic diagram of the state when the present invention is in preparation at the oval aperture.

[0024] In the diagram: 1. Outer tube; 2. Swing rod; 3. Needle tube; 4. Mounting bracket; 5. Drive rod; 6. Insertion channel; 7. Sewing fastener; 8. Connecting wire; 9. Push rod; 10. Insertion tip; 11. First push rod; 12. Second push rod; 13. Mounting plate; 14. Rotating shaft; 15. Docking hole; 16. Limiting rod; 17. Annular groove; 18. Limiting opening; 19. Rotating block; 20. Rotating groove; 22. Track block; 23. Movable channel; 24. Needle exit opening; 25. Exposed groove; 26. Guide arc surface; 27. Push column; 28. Mounting channel; 29. ​​Wire exit groove; 30. Through hole; 31. Wire pulling channel; 32. Docking block; 33. Docking groove; 34. Relief groove; 35. Limiter; 36. Needle exit hole; 37. Wire pulling. Detailed Implementation

[0025] The following are specific embodiments of the present invention, which are described in conjunction with the accompanying drawings. However, the present invention is not limited to these embodiments.

[0026] like Figures 1-10 As shown, the suture head for this patent foramen ovale suture surgery includes an outer tube 1, a swing rod 2, and two needle tubes 3. A mounting bracket 4 is provided at the first end of the outer tube 1. The swing rod 2 is rotatably mounted on the mounting bracket 4. A drive rod 5 is provided inside the outer tube 1. The drive rod 5 is used to pull the swing rod 2 away from its end, thereby rotating the swing rod 2. Two through-channels 6 are symmetrically opened at both ends of the swing rod 2. A suture buckle 7 is provided in each of the two through-channels 6. The two suture buckles 7 are connected by a connecting line 8, and a pull wire is connected to the middle of the connecting line. 37. Two needle tubes 3 are symmetrically arranged on both sides inside the outer tube 1. Each needle tube 3 has a push rod 9 in its lumen and an insertion tip 10. The ends of the two needle tubes 3 away from the insertion tip 10 are connected to a first push rod 11 for pushing the two needle tubes 3 into the two insertion channels 6 respectively. The two push rods 9 are connected to a second push rod 12 for driving the two push rods 9 to extend out of the two needle tubes 3 respectively. After the needle tubes 3 pass through the insertion channels 6, the suture buckle 7 is located in the lumen of the needle tube 3.

[0027] To elaborate further, the mounting bracket 4 includes two mounting plates 13. Each mounting plate 13 has a rotating shaft 14 at its end away from the outer tube 1. The middle of the swing arm 2 has docking holes 15 on both sides for docking with the rotating shaft 14. The docking holes 15 and the rotating shaft 14 correspond one-to-one. Limiting rods 16 are provided on both side walls of the swing arm 2. Limiters 35 are provided on both rotating shafts 14. Annular grooves 17 for the insertion of the limiting rods 16 are provided on the side of the two limiters 35 facing the swing arm 2. Protrusions are provided on both side walls of the annular grooves 17 to form limiting openings 18.

[0028] When the pendulum 2 reaches the oval aperture, the pendulum 2 is first rotated and unfolded by the drive rod 5. After unfolding, the outer tube 1 is operated to make fine adjustments so that the two ends of the pendulum 2 can respectively fit onto the diaphragms on both sides of the oval aperture. During this process, the pendulum 2 will rotate due to the fine adjustment. Therefore, a limiting port 18 is designed. The limiting rod 16 moves in the annular groove 17 as the pendulum 2 rotates. When it moves to the limiting port 18, it can no longer move. This forms a limit on the rotation angle of the pendulum 2. This angle is when the pendulum 2 is perpendicular to the outer tube 1. This design limits the rotation of the pendulum 2 and facilitates the fine adjustment operation.

[0029] To elaborate further, a rotating block 19 is provided at one end of the drive rod 5 near the swing rod 2, and a rotating groove 20 for accommodating the rotating block 19 is provided at the end of the swing rod 2 near the through hole 30;

[0030] During the process of the outer tube 1 entering the human body, the rotating block 19 is located in the rotating groove 20, thereby keeping the swing rod 2 and the outer tube 1 on the same straight line, ensuring that it can enter the human body smoothly. As shown in the attached figure, both the rotating block 19 and the rotating groove 20 are arc-shaped. When it is necessary to rotate to unfold the swing rod 2, the staff pulls the drive rod 5, and the rotating block 19 will gradually leave the rotating groove 20. Due to the arc-shaped surfaces of the rotating block 19 and the rotating groove 20, the swing rod 2 will be driven to rotate during the process of the rotating block 19 leaving, eventually making the swing rod 2 perpendicular to the outer tube 1.

[0031] To elaborate further, the drive rod 5 has a receiving channel at the end furthest from the rotating block 19. A track block 22 is provided in the receiving channel near the rotating block 19. The track block 22 has two movable channels 23 running through it. The two movable channels 23 are used to receive the two needle tubes 3 respectively. Both sides of the drive rod 5 have needle outlet openings 24 that communicate with the receiving channel. Both sides of the track block 22 have needle outlet holes 36, and both sides of the track block 22 are respectively engaged in the two needle outlet openings 24. The two needle outlet holes 36 are respectively connected to the two movable channels 23. Both sides of the outer tube 1 have exposure grooves 25, and the two exposure grooves 25 are used to expose the two needle outlet holes 36 respectively.

[0032] When the drive rod 5 is pulled back to extend the swing arm 2, the drive rod 5 will remain retracted to ensure that it does not interfere with the swing arm 2. The function of the exposed groove 25 is to ensure that the needle hole 36 can be exposed and not blocked by the outer tube 1. Even if the drive rod 5 is retracted, the needle hole 36 can still be exposed, so that the needle tube 3 can extend normally.

[0033] To elaborate further, both needle tubes 3 and both push rods 9 are made of shape memory alloy, and both needle outlet holes 36 are provided with guide arc surfaces 26 on the side near the swing rod 2.

[0034] The shape memory alloy is made of nickel-titanium alloy. Both needle tubes 3 are bent outwards, and both insertion channels 6 are tilted to form an inverted "V" shape. When the needle is withdrawn, the first push rod 11 is pushed, and the needle tube 3 smoothly extends out of the needle hole 36 under the action of the guide arc surface 26 and its own restorative deformation. The original shape of the two needle tubes 3 can ensure that they are accurately inserted into the insertion channel 6. After passing through the insertion channel 6, the two needle tubes 3 are inserted into the septa on both sides of the oval hole and finally pass out of the septa, thus opening up the two channels. Then, the second push rod 12 is pushed so that the two push rods 9 push the two suture buckles 7 out to the other side of the septum along the needle tubes 3. Finally, the needle tubes 3 and push rods 9 are retracted.

[0035] To elaborate further, the first push rod 11 is located within the receiving channel and fixed to the end of the needle tube 3 away from the insertion tip 10. The first push rod 11 is provided with a mounting channel 28 for receiving the second push rod 12. The end of the second push rod 12 near the needle tube 3 is provided with two push posts 27, and the two push posts 27 are respectively fixedly connected to two push rods 9.

[0036] This design reduces space usage and makes operation easier.

[0037] To elaborate further, a wire outlet groove 29 is provided on one side of the swing rod 2, and the two ends of the wire outlet groove 29 are respectively connected to two through channels 6. A through hole 30 is provided on the other side of the swing rod 2, which is connected to the wire outlet groove 29. The through hole 30 is used for the pull wire 37 to pass through. The second push rod 12 and the track block 22 are both provided with a pull channel 31 for the pull wire 37 to pass through.

[0038] Before the surgery, the pull thread 37 will be passed through the threading channel of the second push rod 12 and the track block and then through the hole 30 to connect the pull thread 37 with the connecting line 8. During suturing, the pull thread 37 can be pulled from the outside and then cut.

[0039] To elaborate further, two docking blocks 32 are provided on the side walls of both of the two through channels 6, and two docking grooves 33 are provided on the outer side walls of both of the two sewing buckles 7.

[0040] The docking block 32 and the docking groove 33 correspond one-to-one. When installing the sewing buckle 7, simply align the two docking grooves 33 on the sewing buckle 7 with the docking block 32 and insert it. The operation is simple. Moreover, the direction of the docking groove 33 is the same as the direction of the through-channel 6, which can fix the sewing buckle 7 without interfering with the push rod 9 pushing out the sewing buckle 7.

[0041] To elaborate further, each of the two needle tubes 3 has a relief groove 34 on its side wall that communicates with the lumen of the needle tube 3;

[0042] Because of the docking block 32, a clearance groove 34 is designed. The position of the clearance groove 34 corresponds to the docking block 32 to ensure that the tube wall of the needle tube 3 will not interfere with the docking block 32, so that the needle tube 3 can pass smoothly through the insertion channel 6.

[0043] To elaborate further, a gap is left between the outer wall of the sewing buckle 7 and the side wall of the through-channel 6 for the tube wall of the needle tube 3 to pass through.

[0044] This configuration ensures that when the needle tube 3 passes through the insertion channel 6, the suture buckle 7 will be located inside the lumen of the needle tube 3 and will not be pushed out by the needle tube 3, thus not affecting the subsequent passage of the needle tube 3 through the diaphragm.

[0045] The specific embodiments described herein are merely illustrative of the spirit of the invention. Those skilled in the art to which this invention pertains may make various modifications or additions to the described specific embodiments or use similar methods to substitute them, without departing from the spirit of the invention or exceeding the scope defined by the appended claims.

[0046] Although this document uses a large number of technical terms, the possibility of using other terms is not excluded. These terms are used merely for the convenience of describing and explaining the essence of the invention; interpreting them as any additional limitation would be contrary to the spirit of the invention.

Claims

1. A suture head for suturing patent foramen ovale, characterized in that, Includes an outer tube (1), a swing rod (2), and two needle tubes (3). A mounting bracket (4) is provided at the first end of the outer tube (1). The swing rod (2) is rotatably mounted on the mounting bracket (4). A drive rod (5) is provided inside the outer tube (1). The drive rod (5) is used to allow a person to pull the swing rod (2) away from the end, thereby rotating the swing rod (2). Two through-holes (6) are symmetrically opened at both ends of the swing rod (2). Each through-hole (6) is equipped with a sewing fastener (7), and the two sewing fasteners (7) are connected by a connecting line (…). 8) Connection: A pull wire (37) is connected to the middle of the connecting line (8). Two needle tubes (3) are symmetrically arranged on both sides inside the outer tube (1). A push rod (9) is provided in the lumen of each of the two needle tubes (3). Each of the two needle tubes (3) is provided with an insertion tip (10). The end of each of the two needle tubes (3) away from the insertion tip (10) is connected to a first push rod (11) for pushing the two needle tubes (3) into the two through channels (6) respectively. The two push rods (9) are connected to a device for driving the two push rods (9) to move from their respective positions. The second push rod (12) extends out from the two needle tubes (3). After the needle tube (3) passes through the insertion channel (6), the suture buckle (7) is located in the cavity of the needle tube (3). The drive rod (5) is provided with a rotating block (19) at one end near the swing rod (2). A thread outlet groove (29) is opened on one side of the swing rod (2). The two ends of the thread outlet groove (29) are respectively connected to the two insertion channels (6). A through hole (30) is opened on the other side of the swing rod (2) to connect to the thread outlet groove (29). The through hole (30) is used for The second push rod (12) and the track block (22) are both provided with a pull wire channel (31) for the pull wire (37) to pass through. The swing rod (2) is provided with a rotating groove (20) for accommodating the rotating block (19) near the through hole (30). A gap is left between the outer wall of the sewing buckle (7) and the side wall of the through channel (6) for the tube wall of the needle tube (3) to pass through. The side walls of the two needle tubes (3) are provided with a relief groove (34) that communicates with the lumen of the needle tube (3).

2. The suture head for patent foramen ovale closure surgery according to claim 1, characterized in that, The mounting bracket (4) includes two mounting plates (13). Each of the two mounting plates (13) has a rotating shaft (14) at the end away from the outer tube (1). The middle of the swing rod (2) has docking holes (15) on both sides for docking the rotating shaft (14). The docking holes (15) and the rotating shaft (14) correspond one-to-one. Limiting rods (16) are provided on both sides of the swing rod (2). Limiters (35) are provided on both rotating shafts (14). Annular grooves (17) for the insertion of the limiting rods (16) are provided on the side of the two limiters (35) facing the swing rod (2). Protrusions are provided on both sides of the annular grooves (17) to form limiting openings (18).

3. The suture head for patent foramen ovale closure surgery according to claim 2, characterized in that, The drive rod (5) has a receiving channel at one end away from the rotating block (19). A track block (22) is provided in the receiving channel near the rotating block (19). The track block (22) has two movable channels (23) through it. The two movable channels (23) are used to receive the two needle tubes (3). The drive rod (5) has needle outlet openings (24) on both sides that communicate with the receiving channel. The track block (22) has needle holes (36) on both sides and the two sides of the track block (22) are respectively engaged in the two needle outlet openings (24). The two needle holes (36) are respectively connected to the two movable channels (23). The outer tube (1) has exposure grooves (25) on both sides of its sidewalls. The two exposure grooves (25) are used to expose the two needle holes (36).

4. The suture head for suturing a patent foramen ovale according to claim 3, characterized in that, Both needle tubes (3) and both push rods (9) are made of shape memory alloy, and both needle holes (36) are provided with guide arc surfaces (26) on the side near the swing rod (2).

5. The suture head for suturing a patent foramen ovale according to claim 3, characterized in that, The first push rod (11) is located in the receiving channel and fixed to the end of the needle tube (3) away from the insertion tip (10). The first push rod (11) is provided with an installation channel (28) for receiving the second push rod (12). The end of the second push rod (12) near the needle tube (3) is provided with two push posts (27). The two push posts (27) are fixedly connected to the two push rods (9) respectively.

6. The suture head for suturing a patent foramen ovale according to claim 1, characterized in that, Two connecting blocks (32) are provided on the side walls of the two through channels (6), and two connecting grooves (33) are provided on the outer side walls of the two sewing buckles (7).

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