Patent foramen ovale suture device and use method thereof

Abstract

The present invention relates to a patent foramen ovale suturing device and a method for using the same, comprising an outer tube and an inner tube, wherein the inner tube can slide inside the outer tube, a suture threading groove is provided at the center of the inner tube, two traction needle grooves are symmetrically provided inside the inner tube, the top of the traction needle groove is arc-shaped, a guide block is provided at the end of the inner tube, the edge of the guide block is arc-shaped and aligned with the traction needle groove, an elastic traction needle is provided in the traction needle groove, the elastic traction needle can slide along the traction needle groove and the edge of the guide block, a clamping hole corresponding to the elastic traction needle is provided on the end surface of the outer tube corresponding to the guide block, a thread hook is provided in the clamping hole, and a suture is provided on the elastic traction needle. The present invention is used for minimally invasive surgical suturing when the foramen ovale in the heart is patent, and can avoid the difficulty in operation caused by unclear suture position under cardiac angiography, and effectively improve the surgical efficiency.

Description

Technical field:

[0001] The present invention relates to the technical field of medical devices, and in particular to a patent foramen ovale suturing device and a use method thereof. Background technology:

[0002] The foramen ovale is a small hole between the left and right atrium septums in the heart. It usually closes in the first year after birth. If the foramen ovale of a child older than 3 years old still does not close, it is called patent foramen ovale. In adults, 20% to 25% of foramen ovale are not completely closed. Patent foramen ovale is the most common congenital heart abnormality in adults. The existing treatment generally uses occlusion surgery to place a large metal occluder in the body. However, since the occluder is mostly made of metal materials, long-term implantation in the heart may cause the occluder to gradually corrode due to corrosion by blood and friction caused by heartbeats, releasing toxic substances, which may increase the risk of complications. In addition, placing a metal occluder in the heart may even sound an alarm when passing through security facilities at various airports and railway stations, which is difficult for many patients to accept. Patent No. ZL201822027543.9 sets a metal suture on the openable clamping arm, uses a catheter sheath inserter to pass the clamping arm through the foramen ovale to open the clamping arm, pushes the traction needle to pull the metal suture on the clamping arm and penetrates the diaphragm, and then wraps the two ends of the metal suture together to close it. This structure can perform minimally invasive sutures on the patent foramen ovale, reducing complications caused by implantation of the occluder. However, since the suture is unfolded in the heart by pushing the clamping arm and then hooked and pulled back by the hooked needle of the traction needle, metal sutures must be used in actual surgical operations for the convenience of angiographic observation. Since the metal sutures are very thin, they are difficult to see clearly under cardiac angiography, making it difficult for the traction needle to hook them, which can easily cause difficulties in surgical operations. In addition, the metal sutures left in the heart are also prone to alarms in various security inspection situations, which are not easily accepted by patients. Summary of the invention:

[0003] 1. Technical problems solved:

[0004] The present invention aims to provide a patent foramen ovale suture device and a method of using the same, which are used for patent foramen ovale suture surgery, and solve the problems that the existing suture surgery traction needle is difficult to hook the metal suture, causing difficulty in surgical operation, and the metal suture is easy to sound an alarm in security inspection occasions and is not easily accepted by patients.

[0005] (II) Technical solution:

[0006] In order to solve the above technical problems, the present invention adopts the following technical solutions: a patent foramen ovale suture device, comprising an outer tube and an inner tube, the inner tube can slide inside the outer tube, a suture threading groove is provided at the center of the inner tube, two traction needle grooves are symmetrically provided inside the inner tube, the top of the traction needle groove is arc-shaped, and two guide blocks are symmetrically provided at the end of the inner tube, the edges of the guide blocks are arc-shaped and aligned with the traction needle grooves, an elastic traction needle is provided in the traction needle groove, and the elastic traction needle can slide along the edges of the traction needle groove and the guide block, a clamping hole corresponding to the elastic traction needle is provided on the end surface of the outer tube corresponding to the guide block, a thread hook is provided in the clamping hole, a suture is provided on the elastic traction needle, and the suture passes through the suture threading groove.

[0007] The outer tube and the inner tube can be extended into the heart through the vein along the delivery sheath tube, and the elastic traction needle slides along the traction needle groove and the guide block. Under the action of the guide block, the needle head of the elastic traction needle can be aligned with the clamping hole at the end of the outer tube, and the suture passes through the suture groove and is tied to the needle head of the elastic traction needle. The elastic traction needle can shorten the distance between the inner tube and the end of the outer tube by moving the inner tube to be inserted into the clamping hole. The thread hook in the clamping hole is used to hook the suture. After the elastic traction needle withdraws from the clamping hole, the suture is hooked by the thread hook and can be pulled out of the body with the outer tube, so that it is convenient to tie a knot outside the body and then push it back into the heart through the knot pusher to suture the oval foramen. The suture is automatically hooked and clamped by the thread hook, which can avoid the difficulty of surgical operation caused by unclear visibility of the suture under cardiac angiography. The suture can also be made of metal suture, which is easy for patients to accept.

[0008] Furthermore, the elastic traction needle includes a needle head, a needle tip and a needle body, the needle head is provided with a threading hole, the needle tip is provided with a thread groove connected to the threading hole, the threading hole is used for the suture to pass through and be bound to the needle tip, the thread groove facilitates the suture to be hooked by the thread hooker, when the elastic traction needle is pulled out from the clamping hole, the suture can be pulled out along the thread groove and retained in the clamping hole, thereby preventing the suture from exiting the clamping hole along with the elastic traction needle, resulting in failure of suture traction.

[0009] Furthermore, the thread hook includes two symmetrically arranged clamping plates, which are connected to the inner wall of the clamping hole by a compression spring, and each of the two clamping plates is provided with a barb opposite to each other. The clamping plate can clamp the elastic traction needle under the action of the compression spring, and the barb is used to hook the suture to ensure that the suture is removed from the elastic traction needle by the thread hook.

[0010] Furthermore, the opposite side of the two clamping plates is conical, forming a conical clamping hole, the barb is arranged in the conical clamping hole, and a plurality of wedge-shaped scraping teeth are also arranged in the conical clamping hole. The conical clamping hole and the wedge-shaped scraping teeth can further ensure that the suture is firmly clamped and the suture is successfully pulled.

[0011] Furthermore, the elastic traction needle is made of spring steel or memory alloy to ensure that the elastic traction needle has sufficient elasticity and toughness and can turn along the traction needle groove and the guide block.

[0012] Furthermore, the suture is absorbable and does not need to be removed, and can be absorbed by the human body after the foramen ovale is closed. It does not need to be removed and will not be detected by metal detectors, thus protecting the patient's personal privacy.

[0013] The present invention also discloses a method for using a patent foramen ovale suture device, comprising the following steps:

[0014] Step 1, respectively tying the two ends of the suture to the needle tips of the two elastic traction needles, using a delivery sheath to pass through the vein into the heart, using angiography to observe and locate, delivering the outer tube along the delivery sheath to the position of the oval foramen in the heart, pushing the inner tube along the outer tube, allowing the end of the inner tube to pass through the oval foramen, so that the end of the outer tube and the end of the inner tube are respectively on both sides of the oval foramen;

[0015] Step 2, pushing the elastic traction needle so that the needle head of the elastic traction needle extends along the edge of the guide block and is aligned with the clamping hole, then pulling the inner tube so that the inner tube is retracted into the outer tube, the elastic traction needle passes through the cardiac septum on both sides of the oval foramen and is inserted into the clamping hole, and the thread hooker hooks the suture on the elastic traction needle;

[0016] Step 3, the elastic traction needle is pulled back along the traction needle groove, the elastic traction needle is withdrawn from the clamping hole and retracted into the traction needle groove, the suture is removed from the elastic traction needle by the thread hook, the outer tube is pulled to pull the two ends of the suture out of the body, the middle of the suture passes through the suture groove into the heart, and then the inner tube is pulled out, at this time, the two ends of the suture pass through the heart septum on both sides of the oval foramen respectively;

[0017] Step 4, after tying a knot at the end of the suture in vitro, use a knot pusher to push the knot along the delivery sheath to the foramen ovale, tighten the cardiac septum on both sides of the foramen ovale, and complete the closure of the foramen ovale.

[0018] (III) Beneficial effects:

[0019] Compared with the prior art, the beneficial effects of the present invention are as follows: by arranging a traction needle groove and a guide block in the inner tube, the traction needle can be turned along the traction needle groove and the guide block and inserted into the clamping hole arranged on the outer tube; a suture is arranged on the traction needle, and a thread hook for removing the suture from the traction needle is arranged in the clamping hole; after the traction needle is used to penetrate the cardiac septum on both sides of the oval foramen and insert the suture into the clamping hole, the suture on the traction needle can be removed by the thread hook and the traction needle can be retracted; the end of the suture can be pulled out of the body with the outer tube and tied, thereby realizing the closure of the oval foramen using sutures, without having to search for sutures under cardiac angiography, facilitating surgical operations, and at the same time, metal sutures can be used instead of sutures to avoid alarms in security inspection situations, which is easy for patients to accept. Description of the drawings:

[0020] In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the drawings required for use in the embodiments are briefly introduced below.

[0021] Figure 1 is a cross-sectional view of a patent foramen ovale suturing device according to an embodiment of the present invention;

[0022] Figure 2 is a transverse cross-sectional view of a patent foramen ovale suture device according to an embodiment of the present invention;

[0023] Figure 3 is a partial cross-sectional view of the patent foramen ovale suturing device according to the embodiment of the present invention when the elastic traction needle is not inserted into the clamping hole;

[0024] Figure 4 A partial cross-sectional view of the elastic traction needle of the patent foramen ovale suturing device according to an embodiment of the present invention when the elastic traction needle is inserted into the clamping hole;

[0025] Figure 5 A schematic diagram of the inner tube passing through the foramen ovale when the patent foramen ovale suturing device according to an embodiment of the present invention is used;

[0026] Figure 6 is a schematic diagram of the elastic traction needle penetrating the cardiac septum when the patent foramen ovale suturing device according to an embodiment of the present invention is used;

[0027] Figure 7 A schematic diagram of the outer tube pulling the suture when the patent foramen ovale suture device according to an embodiment of the present invention is used;

[0028] Figure 8 A schematic diagram of the patent foramen ovale suturing device according to an embodiment of the present invention when the suture is used and a knot is tied after the suture is pulled;

[0029] Fig. 9 A schematic diagram of the suture knotting when the patent foramen ovale suture device according to the embodiment of the present invention is used;

[0030] In the figure: 1, outer tube; 2, inner tube; 3, suture threading groove; 4, traction needle groove; 5, guide block; 6, elastic traction needle; 61, needle head; 62, needle tip; 63, needle body; 64, threading hole; 65, thread groove; 7, clamping hole; 8, thread hook; 81, clamping plate; 82, compression spring; 83, barb; 84, tapered clamping hole; 85, wedge-shaped scraping teeth; 9, suture; 10, delivery sheath; 11, cardiac diaphragm; 12, knot pusher Specific implementation method:

[0031] The technical solutions in the embodiments of the present invention will be described clearly and completely below in conjunction with the accompanying drawings in the embodiments of the present invention.

[0032] like Figure 1 , Figure 2 , Figure 3 , Figure 4 , Figure 5 , Figure 6 , Figure 7 , Figure 8 and Fig. 9 The foramen ovale suture device shown comprises an outer tube 1 and an inner tube 2, wherein the inner tube 2 can slide inside the outer tube 1, a suture threading groove 3 is provided at the center of the inner tube 2, two traction needle grooves 4 are symmetrically provided inside the inner tube 2, the top of the traction needle groove 4 is arc-shaped, two guide blocks 5 are symmetrically provided at the end of the inner tube 2, the edges of the guide blocks 5 are arc-shaped and aligned with the traction needle groove 4, an elastic traction needle 6 is provided in the traction needle groove 4, the elastic traction needle 6 can slide along the edges of the traction needle groove 4 and the guide blocks 5, a clamping hole 7 corresponding to the elastic traction needle 6 is provided on the end face of the outer tube 1 corresponding to the guide block 5, a thread hook 8 is provided in the clamping hole 7, a suture 9 is provided on the elastic traction needle 6, and the suture 9 passes through the suture threading groove 3.

[0033] Preferably, the elastic traction needle 6 includes a needle head 61, a needle tip 62 and a needle body 63. The needle head 61 is provided with a threading hole 64, and the needle tip 62 is provided with a thread groove 65 connected to the threading hole 64. The threading hole 64 is used for the suture 9 to pass through and be bound to the needle tip 61. The thread groove 65 facilitates the suture 9 to be hooked by the thread hook 8. When the elastic traction needle 6 is pulled out from the clamping hole 7, the suture 9 can be pulled out along the thread groove 65 and retained in the clamping hole 7, thereby preventing the suture 9 from withdrawing from the clamping hole 7 along with the elastic traction needle 6, resulting in failure in traction of the suture 9.

[0034] Preferably, the thread hook 8 includes two symmetrically arranged clamping plates 81, which are connected to the inner wall of the clamping hole 7 by a compression spring 82. A barb 83 is provided opposite to each other on the two clamping plates 81. The clamping plates 81 can clamp the elastic traction needle 6 under the action of the compression spring 82, and the barb 83 is used to hook the suture 9 to ensure that the suture 9 is removed from the elastic traction needle 6 by the thread hook 8.

[0035] Preferably, the opposite side of the two clamping plates 81 is conical, forming a conical clamping hole 84, and the barb 83 is arranged in the conical clamping hole 84. A plurality of wedge-shaped scraping teeth 85 are also provided in the conical clamping hole 84. The conical clamping hole 84 and the wedge-shaped scraping teeth 85 can further ensure that the suture 9 is firmly clamped and the suture 9 is successfully pulled.

[0036] Preferably, the elastic traction needle 6 is made of spring steel or memory alloy to ensure that the elastic traction needle 6 has sufficient elasticity and toughness and can turn along the traction needle groove 4 and the guide block 5 .

[0037] Preferably, the suture 9 is absorbable and non-removable, which can be absorbed by the human body after the foramen ovale is closed. It does not need to be removed and will not be detected by metal detectors, thus protecting the patient's privacy.

[0038] The outer tube 1 and the inner tube 2 can be extended into the heart through the vein along the delivery sheath 10, and the elastic traction needle 6 slides along the traction needle groove 4 and the guide block 5. Under the action of the guide block 5, the needle head 61 of the elastic traction needle 6 is aligned with the clamping hole 7 at the end of the outer tube 1. The suture 9 passes through the suture threading groove 3 and is tied to the needle head 61 on the elastic traction needle 6 through the threading hole 64. The elastic traction needle 6 can be inserted into the clamping hole 7 by moving the inner tube 2 to shorten the distance between the inner tube 2 and the end of the outer tube 1. The clamping hole The thread hook 8 in 7 is used to hook the suture 9. After the elastic traction needle 6 withdraws from the clamping hole 7, the suture 9 is hooked by the barb 83 and the wedge-shaped scraper 95 in the thread hook 8 and can be pulled out of the body along with the outer tube 1, so that it is convenient to tie a knot outside the body and then push it back into the heart through the knot pusher 12 to suture the oval foramen. The suture 9 is automatically hooked and clamped by the thread hook 8, which can avoid the difficulty of surgical operation caused by unclear visibility of the suture 9 under cardiac angiography. The suture 9 uses absorbable suture-free sutures, which do not need to be removed and are easy for patients to accept.

[0039] A method for using a patent foramen ovale suture device according to an embodiment of the present invention comprises the following steps:

[0040] Step 1: Pass the suture 9 through the suture threading groove 3, and the two ends of the suture 9 are respectively passed through the threading holes 64 and bound to the needle heads 61 of the two elastic traction needles 6. Use the delivery sheath 10 to pass through the vein into the heart, and with the help of angiography observation and positioning, the outer tube 1 is delivered to the position of the oval foramen in the heart along the delivery sheath 10, and the inner tube 2 is pushed along the outer tube 1, so that the end of the inner tube 2 passes through the oval foramen, so that the end of the outer tube 1 and the end of the inner tube 2 are respectively on both sides of the oval foramen;

[0041] Step 2: Push the elastic traction needle 6 so that the needle head 61 of the elastic traction needle 6 extends along the edge of the guide block 5 and is aligned with the clamping hole 7. Then pull the inner tube 2 to retract the inner tube 2 into the outer tube 1. The elastic traction needle 6 passes through the cardiac septum 11 on both sides of the oval foramen and is inserted into the clamping hole 7. The thread hook 8 hooks the suture 9 on the elastic traction needle 6.

[0042] Step 3: Pull back the elastic traction needle 6 along the traction needle groove 4, the elastic traction needle 6 withdraws from the clamping hole 7 and retracts into the traction needle groove 4, the clamping plate 81 and the barb 83 on the thread hook 8 remove the suture 9 from the elastic traction needle 6, pull the outer tube 1 to pull the two ends of the suture 9 out of the body, and the middle of the suture 9 enters the heart through the suture threading groove 3, and then pull out the inner tube 2, at this time, the two ends of the suture 9 pass through the heart septum 11 on both sides of the oval foramen respectively;

[0043] Step 4, after tying a knot at the end of the suture 9 in vitro, use a knot pusher 12 to push the knot along the delivery sheath 10 to the foramen ovale, tighten the cardiac septum 11 on both sides of the foramen ovale, and complete the closure of the foramen ovale.

[0044] In summary, the patent foramen ovale suture device and the use method thereof provided by the present invention are used for suture surgery of patent foramen ovale, which solves the problems that the existing suture surgery traction needle is difficult to hook the metal suture, causing difficulty in surgical operation, and the metal suture is easy to sound an alarm in security inspection occasions and is not easily accepted by patients.

[0045] The present invention is described above by way of examples, but the present invention is not limited to the above specific embodiments, and any changes or modifications made based on the present invention belong to the scope of protection claimed by the present invention.

Claims

1. A patent foramen ovale suture device, characterized in that: The invention comprises an outer tube and an inner tube, wherein the inner tube can slide inside the outer tube, a suture threading groove is arranged at the center of the inner tube, two traction needle grooves are symmetrically arranged inside the inner tube, the top of the traction needle groove is arc-shaped, two guide blocks are symmetrically arranged at the end of the inner tube, the edges of the guide blocks are arc-shaped and aligned with the traction needle grooves, an elastic traction needle is arranged in the traction needle groove, and the elastic traction needle can slide along the edges of the traction needle groove and the guide blocks, a clamping hole corresponding to the elastic traction needle is arranged on the end surface of the outer tube corresponding to the guide block, and a thread hook is arranged in the clamping hole, The elastic traction needle is provided with a suture, and the suture passes through the suture groove. The elastic traction needle includes a needle head, a needle tip and a needle body. The needle head is provided with a threading hole, and the needle tip is provided with a thread groove connected to the threading hole. The thread hook includes two symmetrically arranged clamping plates, and the clamping plates are connected to the inner wall of the clamping hole by a compression spring. A barb is provided on each of the two clamping plates opposite to each other, and the opposite sides of the two clamping plates are conical to form a conical clamping hole. The barb is arranged in the conical clamping hole, and a plurality of wedge-shaped scraping teeth are also provided in the conical clamping hole.

2. A patent foramen ovale suture device according to claim 1, characterized in that: The elastic traction needle is made of spring steel or memory alloy.

3. The patent foramen ovale suture device according to claim 1, characterized in that: The sutures are absorbable and non-removable.

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