A valve annuloplasty ring system

Abstract

The present invention relates to an annuloplasty ring system for interventional surgery to treat tricuspid regurgitation diseases, belonging to the technical field of medical devices. It includes a clamping system for clamping the tricuspid annulus multiple times, an operating system for controlling the opening and closing of the clamping system, an annuloplasty ring system for reducing the opening of the tricuspid annulus, an adjustment system for secondarily adjusting the circumference and shape of the annuloplasty ring, a catheter delivery system, and a deflection system for adjusting the direction of the catheter; the annuloplasty ring system includes an annuloplasty ring, and a plurality of clamping systems are provided on the annuloplasty ring; the clamping system is provided with a valve annulus clip for clamping the tricuspid annulus, a locking structure, and an annuloplasty ring clip for clamping the annuloplasty ring; the locking structure includes a two-gear structure for converting the valve annulus clip to an open or closed state; the valve annulus clip can adjust its position to clamp the tricuspid annulus multiple times. The problem of tricuspid valve regurgitation is effectively solved by the present invention, and it is a relatively safe, simple, and efficient tricuspid annuloplasty ring system.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and particularly relates to an annuloplasty ring system for interventional surgery to treat tricuspid regurgitation disease. Background Art

[0002] Valve regurgitation is one of the most common heart diseases, mainly caused by a series of pathophysiological changes resulting from blood backflow caused by structural or functional changes in the ventricle, papillary muscle, annulus and leaflets, which lead to poor anastomosis of the anterior and posterior leaflets of the valve. Drug treatment can improve the symptoms of patients to a certain extent, but the long-term effect is generally average. Valve repair or valve replacement through surgical operation is considered the standard treatment method for this disease, and it has been proven to relieve the symptoms of patients and extend their lifespan. However, surgical operations generally need to be performed through thoracotomy, so they have disadvantages such as large trauma and high risks, and are particularly unsuitable for elderly patients with serious underlying diseases.

[0003] In recent years, with the continuous development and progress of minimally invasive interventional valve treatment technology, percutaneous catheter surgery to treat valve diseases has currently become one of the key research and development directions of cardiovascular medical devices at home and abroad. The existing interventional methods for treating valve regurgitation mainly involve clamping the regurgitant leaflets, and the method of using annuloplasty to treat valve regurgitation is relatively rare. Most of them use penetrating the annulus to achieve a fixation effect. For example, the contents disclosed in Chinese Patent Tricuspid Valve Repair Device (CN 104000625 A), Tissue Anchor and Percutaneous Tricuspid Valve Repair Using Tissue Anchor (CN 107427296 A), etc. Such methods are prone to risks such as stenosis of the coronary sinus ostium and cardiac penetration, and these methods require the catheter to pass through the right atrium to reach the right ventricle for operation, which will greatly increase the risk of damaging the valve itself and the operation difficulty; while the existing technologies for treating valve regurgitation using the annuloplasty scheme currently have many defects. For example, in Chinese Patent, the patent number is (CN110916851B). In this technical solution, the clip for clamping the annulus cannot be reliably opened and closed multiple times for clamping, so that after the valve is clamped, the clamped position of the valve cannot be adjusted multiple times; when it is found during the operation that the shaping effect is not ideal, the shape of the annuloplasty ring cannot be conveniently adjusted again, the surgical error tolerance rate is low, and the operation difficulty of the system is large.

[0004] In addition, most of the tricuspid annulus repair devices in the market have a single access method and are not applicable to some patients with vascular diseases, so the clinical application range is relatively narrow. Therefore, there is an urgent need in this technical field for an annuloplasty ring system with diverse surgical access methods, less trauma, high safety, and adjustable. Summary of the Invention

[0005] The object of the present invention is to solve the technical problem of how to obtain a valve annuloplasty ring system that can overcome the defects of the prior art, has various surgical approaches, less trauma, high safety, and is adjustable.

[0006] To achieve the above object, the technical solution adopted by the present invention is to provide a valve annuloplasty ring system, which includes a clamping system for clamping the tricuspid valve annulus multiple times, an operating system for controlling the opening and closing of the clamping system, an annuloplasty ring system for reducing the opening of the tricuspid valve annulus, an adjustment system for secondary adjustment of the annulus perimeter and shape, a catheter delivery system, and a deflection system for adjusting the catheter direction; the catheter delivery system includes a catheter for delivering the clamping system, the operating system, the annuloplasty ring system, and the adjustment system; the annuloplasty ring system includes an annuloplasty ring, and a plurality of clamping systems are provided on the annuloplasty ring; the clamping system is provided with a valve annulus clip for clamping the tricuspid valve annulus, a locking structure, and an annuloplasty ring clip for clamping the annuloplasty ring; the locking structure includes a two-gear structure for converting the valve annulus clip to an open or closed state; the valve annulus clip can adjust its position to clamp the tricuspid valve annulus multiple times

[0007] Preferably, the valve annulus clip is connected to the annuloplasty ring clip through the locking structure; a first guide wire for passing through and pulling and contracting the perimeter of the tricuspid valve annulus of the annuloplasty ring is threaded through the annuloplasty ring clip.

[0008] Preferably, the valve annulus clip includes two left and right clamping arms, and biomaterial felt pieces capable of increasing the friction between the valve annulus clip and the valve annulus tissue and improving the clamping firmness are respectively provided on the inner sides corresponding to the two clamping arms.

[0009] Preferably, joint mechanisms are respectively provided at the upper and lower ends of the locking structure for connecting with the valve annulus clip and the annuloplasty ring clip; a two-gear structure for closing or opening is provided in the locking structure, and when the locking structure is in the closed or open state, the valve annulus clip and the annuloplasty ring clip are controlled to close or open synchronously by driving the joint mechanism.

[0010] Preferably, the locking structure includes two corresponding working arms, a return spring for pulling the two working arms closer and a locking turntable for adjusting the distance between the two working arms are provided between the two working arms; the locking structure is in any one of the two gears of closed or open through the return spring.

[0011] Preferably, the locking turntable has two length states of long and short that alternate cyclically; the long locking turntable corresponds to the open gear of the locking structure, and the valve annulus clip and the annuloplasty ring clip are synchronously in the open state; the short locking turntable corresponds to the closed gear of the locking structure, and the valve annulus clip and the annuloplasty ring clip are synchronously in the closed state;

[0012] Preferably, the locking turntable includes locking teeth provided on one side and two types of tooth grooves provided on the other side that respectively abut against the locking teeth; the locking teeth are set to be rotatable and alternately abut against the two types of tooth grooves in a cyclic manner, and when abutting against the two types of tooth grooves, they respectively correspond to two length states of the locking turntable that alternately change in length; on one side of the tooth groove along the length direction of the locking turntable, there is a first ejector rod for overcoming the pulling force of the return spring to abut against the locking teeth and pulling apart the distance between the locking teeth and the tooth groove; the end of the first ejector rod away from the locking teeth movably penetrates through the outside of one side working arm; a second ejector rod is provided in parallel with the first ejector rod, one end of the second ejector rod is fixedly connected to the one side working arm passing through the first ejector rod, and the other end of the second ejector rod movably penetrates through the outside of the other side working arm.

[0013] Preferably, the operating system includes two clamps that can be opened and closed; there are movable connection structures between the two clamps and the two working arms of the locking structure respectively; when the two clamps are connected to the two working arms, the two clamps respectively abut against the first ejector rod and the second ejector rod.

[0014] Preferably, the adjustment system includes a second guide wire, two clips provided on the second guide wire for clamping the first forming ring guide wire, a wire tying device for tying a knot to the pulled wire in a ring shape, and an adjustment system delivery catheter; the second guide wire and the wire tying device are arranged in the adjustment system delivery catheter.

[0015] Preferably, the wire tying device is made of a metal material with plasticity and superelasticity.

[0016] Preferably, the catheter delivery system includes an outer sleeve, a middle sleeve, an inner sleeve, and a catheter inside the sleeve; the outer sleeve, the middle sleeve, and the inner sleeve are structures that are nested layer by layer.

[0017] Compared with the prior art, the present invention has the following beneficial effects:

[0018] The present invention can be applied to tricuspid valve regurgitation diseases, has various surgical access methods, and effectively solves the problem of tricuspid valve regurgitation; compared with traditional surgeries, it has obvious minimally invasive advantages. It can perform valve plasty and evaluate its effect under the guidance of imaging equipment such as echocardiogram and X-ray in a completely physiological state, facilitating surgeons to accurately and quickly treat the regurgitant valve, and at the same time avoiding postoperative complications caused by traditional surgeries to high-risk patients; compared with the prior art, the present invention only needs to operate in the right atrium without crossing the valve to enter the ventricle for operation, avoiding risks such as possible valve damage, coronary artery ostium occlusion, and cardiac rupture, and is a relatively safe, simple, and efficient tricuspid annuloplasty system. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Figure 1 is a schematic diagram of the overall structure of an embodiment of a surgical access method according to the present invention.

[0020] Figure 2 It is a schematic diagram of the overall structure of an embodiment of another surgical approach according to the present invention.

[0021] Figure 3 It is a schematic diagram of the open structure of the operating system and the clamping system according to an embodiment of the present invention.

[0022] Figure 4 It is a schematic diagram of the closed structure of the operating system and the clamping system according to an embodiment of the present invention.

[0023] Figure 5 It is a schematic diagram of the internal rotation locking structure of a locking structure according to the present invention Figure 1 .

[0024] Figure 6 It is a schematic diagram of the internal rotation locking structure of a locking structure according to the present invention Figure 2 .

[0025] Figure 7 It is a schematic diagram of the overall structure of the tricuspid annuloplasty ring system according to the present invention.

[0026] Figure 8 It is a schematic diagram of the structure of the secondary adjustment system grasping the annuloplasty ring according to an embodiment of the present invention.

[0027] Figure 9 It is a schematic diagram of the structure of the secondary adjustment system during the tightening and fastening process according to an embodiment of the present invention.

[0028] Figure 10 It is a schematic cross-sectional view of the three-layer sleeve structure according to the present invention.

[0029] Reference numerals: 1. catheter delivery system; 2. deflection system; 3. clamping system; 4. operating system; 41. clamp; 42. magnetic attraction structure; 43. concave-convex component; 5. annuloplasty ring system; 51. guide wire 1; 6. adjustment system; 61. small clip; 62. guide wire 2; 63. ring tying device; 11. outer sleeve; 12. middle sleeve; 13. inner sleeve; 14. operating guide wire; 21. snake bone structure 1; 22. snake bone structure 2; 31. clip; 32. annulus clamp; 321. clamping arm 1; 322. clamping arm 2; 323. barb device; 324. opening; 325. felt sheet 1; 326. felt sheet 2; 33. locking structure; 331. return spring; 332. locking turntable; 333. locking tooth; 334. deep tooth groove; 335. shallow tooth groove; 336. ejector rod 1; 337. ejector rod 2; 338. working arm; 34. annuloplasty ring clamp; 341. high friction material. Detailed implementation manners

[0030] To make the present invention more obvious and understandable, the following is a detailed description with preferred embodiments and accompanying drawings:

[0031] As Figures 1-10As shown in the figure, the technical solution adopted by the present invention is to provide a valve annuloplasty ring system, which includes a clamping system 3 for clamping the tricuspid annulus multiple times, an operating system 4 for controlling the opening and closing of the clamping system 3, an annuloplasty ring system 5 for reducing the opening of the tricuspid annulus, an adjustment system 6 for secondarily adjusting the perimeter and shape of the annuloplasty ring, a catheter delivery system 1, and a deflection system 2 for adjusting the direction of the catheter; the catheter delivery system 1 includes a catheter for delivering the clamping system 3, the operating system 4, the annuloplasty ring system 5, and the adjustment system 6; the annuloplasty ring system 5 includes an annuloplasty ring, and a plurality of clamping systems 3 are provided on the annuloplasty ring; the clamping system 3 is provided with an annulus clip 32 for clamping the tricuspid annulus, a locking structure 33, and an annuloplasty ring clip 34 for clamping the annuloplasty ring; the locking structure 33 includes a two-gear structure for converting the annulus clip 32 to an open or closed state; the annulus clip 32 can adjust its position to clamp the tricuspid annulus multiple times. The annulus clip 32 is connected to the annuloplasty ring clip 34 through the locking structure 33; a guide wire 51 of the annuloplasty ring that can contract the perimeter of the tricuspid valve annulus by pulling is threaded through the annuloplasty ring clip 34. The annulus clip 32 includes left and right clamping arms, and biomaterial felts for increasing the friction between the annulus clip and the annulus tissue and improving the clamping firmness are respectively provided on the inner sides corresponding to the two clamping arms. Joint mechanisms are respectively provided at the upper and lower ends of the locking structure 33 to connect with the annulus clip 32 and the annuloplasty ring clip 34; a two-gear structure for closing or opening is provided in the locking structure 33. When the locking structure 33 is in a closed or open state, the annulus clip 32 and the annuloplasty ring clip 34 are controlled to close or open synchronously by driving the above-mentioned joint mechanisms. The locking structure 33 includes two corresponding working arms 338, a return spring 331 for pulling the two working arms 338 closer and a locking turntable 332 for adjusting the distance between the two working arms 338 are provided between the two working arms 338; the locking structure 33 is in either of the two gears of closed or open through the return spring 331.The locking turntable 332 is provided with two states of long and short lengths that cycle and alternate; the long locking turntable 332 corresponds to the locking structure 33 being in the open position, and the petal ring clamp 32 and the forming ring clamp 34 are synchronously in the open state; the short locking turntable 332 corresponds to the locking structure 33 being in the closed position, and the petal ring clamp 32 and the forming ring clamp 34 are synchronously in the closed state; the locking turntable 332 includes locking teeth 333 provided on one side and two types of tooth grooves provided on the other side that respectively abut against the locking teeth 333; the locking teeth 333 are set to be rotatable and cycle and alternately abut against the two types of tooth grooves, and when abutting against the two types of tooth grooves, they respectively correspond to the two alternating states of long and short lengths of the locking turntable 332; on one side of the tooth groove along the length direction of the locking turntable 332, there is a first ejector rod 336 for abutting against the locking teeth 333 to overcome the pulling force of the return spring 331 and pull open the distance between the locking teeth 333 and the tooth groove; the end of the first ejector rod 336 away from the locking teeth 333 movably passes through the outside of one side working arm; a second ejector rod 337 is provided in parallel with the first ejector rod 336, one end of the second ejector rod 337 is fixedly connected to one side working arm, and the other end movably passes through the outside of the other side working arm. The operating system 4 includes two clamps 41 that can be opened and closed; there is a movable connection structure between the two clamps 41 and the two working arms 338 of the locking structure 33 respectively; when the two clamps 41 are connected to the two working arms 338, the two clamps 41 respectively abut against the first ejector rod 336 and the second ejector rod 337. The adjustment system 6 includes a second guide wire 62, two small clips 61 provided on the second guide wire 62 for clamping the forming ring guide wire 51, a tying device 63 for tying a knot on the guide wire 51 that forms a ring after being pulled, and an adjustment system delivery catheter; the second guide wire 62 and the tying device 63 are provided in the adjustment system delivery catheter. The tying device 63 is made of a metal material with plasticity and superelasticity. The catheter delivery system includes an outer sleeve 11, a middle sleeve 12, an inner sleeve 13, and a catheter inside the sleeve; the outer sleeve 11, the middle sleeve 12, and the inner sleeve 13 are structures nested layer by layer.

[0032] As Figures 1-10As shown in the figure, the present invention provides a valve annuloplasty ring system, comprising: a catheter delivery system 1 for delivering a clamping system 3 and an annuloplasty ring system 5, a deflection system 2 for adjusting the direction of the catheter, a clamping system 3 for clamping the tricuspid annulus, an operating system 4 for controlling the opening, closing and locking of the clamping system 3, an annuloplasty ring system 5 for reducing the opening of the tricuspid annulus, and an adjustment system 6 for secondarily adjusting the annuloplasty ring. Among them, the catheter delivery system 1 is composed of an outer sleeve 11, a middle sleeve 12 and an inner sleeve 13 and corresponding system catheters. The three layers of sleeves are nested one inside the other. Among them, the outer sleeve 11 is used to deliver the middle sleeve 12 and the inner sleeve 13 to the corresponding right atrium; there are several middle sleeves 12, which are respectively used for the delivery of the clamping system 3, the operating system 4 and the annuloplasty ring system 5; each middle sleeve 12 contains a corresponding catheter, which contains a guide wire inside, used to control the mechanical device at the distal end. The deflection system 2 is located on the outer periphery of the outer sleeve 11 and the middle sleeve 12, and is used to pass through the positions that need to be bent in the human anatomical structure. The deflection of the deflection system 2 is mainly achieved by a snake bone structure, so as to ensure that the whole system can accurately reach the specified tricuspid regurgitation ring position and complete a series of delicate operations.

[0033] The clamping system 3 includes several clips 31, which are used to clamp the regurgitant tricuspid annulus and connect the annuloplasty ring. The clip 31 includes three parts, namely, a valve annulus clip 32, a locking structure 33 and an annuloplasty ring clip 34. The valve annulus clip 32 is located at the bottom of the whole clip 31 and is used to clamp the regurgitant valve annulus; the locking structure 33 is located between the valve annulus clip 32 and the annuloplasty ring clip 34 and is used to lock the positions of the valve annulus clip 32 and the annuloplasty ring clip 34; the annuloplasty ring clip 34 is located at the top, and an annuloplasty ring is strung in the annuloplasty ring clip 34, and the annuloplasty ring is pulled to play a role in shrinking the valve annulus.

[0034] The operating system 4 is used to control the clamping system 3 and includes a set of dedicated delivery catheters and a clamp 41 at the end. The size of the clamp 41 is larger than the whole clamping system 3, and it is connected to the locking structure 33 of the clamping system 3 by magnetic attraction and concave-convex parts, and can control the position, opening and closing and locking of the clamping system 3.

[0035] The annuloplasty ring system 5 includes a nitinol guide wire 51 with a memory elastic function and a corresponding delivery catheter. Several clamping systems 3 are strung on the guide wire 51, and adjacent clamping systems 3 are pulled by the annuloplasty ring to play a role in shrinking the tricuspid annulus.

[0036] The secondary adjustment system 6 includes a guide wire 62 with two small clips 61, a corresponding delivery catheter and a tying ring device 63. When the annuloplasty ring is successfully placed and needs to be tightened again, the secondary adjustment system 6 can be used to grab the corresponding loose annuloplasty ring guide wire 51, pull the guide wire 51 to shrink the annuloplasty ring, and release the tying ring device 63, so as to play a role in tightening the annuloplasty ring.

[0037] The inner diameters of the outer, middle, and inner sleeves decrease layer by layer and can be adjusted accordingly according to specific surgical requirements. The maximum transmission distance of each layer of the sleeve can also be adjusted. The three-layer sleeve delivery system is independently controlled and does not interfere with each other.

[0038] The snake bone structure in the deflection system 2 can be adjusted to the desired position according to specific operating requirements and can be divided into a single-layer snake bone structure and a double-layer snake bone structure according to the degree of operating fineness. (For specific detailed structures, please refer to Chinese Patent: Patent Name: A Bilateral Snake Bone Structure Device, Authorization Publication Number: CN215272599U).

[0039] The inner wall of the forming ring clamp at the top of the clamping system 3 is coated with a high-friction material 341, which can firmly clamp the guide wire 51 of the forming ring after locking and will not slide anymore.

[0040] The tricuspid annulus clamp 32 at the bottom of the clamping system 3 includes two left and right clamping arms. The inner layers of the clamping arms each contain two pieces of biological material felt, which can increase the friction between the tricuspid annulus clamp and the annulus tissue and improve the firmness of clamping.

[0041] Barb-like barb devices 323 are respectively included on the clamping arms on both sides of the tricuspid annulus clamp 32, and openings 324 corresponding to the barb devices 323 are provided on the corresponding other clamping arms, which can ensure that when the tricuspid annulus clamp closes, it penetrates the tricuspid annulus and passes through the opening 324 to ensure the stability of the closure of the tricuspid annulus clamp.

[0042] Articulating mechanisms are respectively provided at the upper and lower ends of the locking structure 33 and are connected to the tricuspid annulus clamp 32 and the forming ring clamp 34 respectively. When the locking structure 33 closes or opens, the upper and lower forming ring clamp 34 and the annulus clamp 32 are indirectly controlled to close or open together by driving the articulating mechanisms.

[0043] The locking structure 33 internally includes a return spring 331 connecting the two ends and a locking turntable 332 in the middle. The return spring 331 ensures that the upper forming ring clamp 34 and the lower annulus clamp 32 are synchronously in either the open state or the closed state. The central locking turntable 332 includes locking teeth 333 on one side and two types of tooth grooves on the other side that are in different abutting positions with the locking teeth 333; a first ejector rod 336 is included inside the tooth grooves; when the two ends of the locking turntable 332 are pressed / relaxed, the locking teeth 333 will alternately slide onto one type of tooth groove; when the locking teeth 333 slide onto a deep tooth groove 334, since the length of this tooth groove is deep, the distance between the two ends of the locking turntable 332 becomes shorter, and the locking structure 33 becomes the closed state; when the two ends of the locking turntable 332 are pressed / relaxed again, the locking teeth 333 leave the original deep tooth groove 334 and enter another shallow tooth groove 335. Since the length of this tooth groove is shallow, the distance between the two ends of the locking turntable 332 becomes larger, and the locking structure 33 becomes the open state.

[0044] In the operating system 4, a magnetic attraction structure 42 is provided between the clamp 41 and the locking structure 33, and a concave-convex component 43 for convenient positioning is provided. The clamp 41 can tightly hold the locking structure 33 of the clamping system 3 by means of magnetic attraction and the concave-convex structure. By operating the guide wire 14 to control the opening and closing of the clamp 41, the opening and closing of the clamping system 3 can be controlled, thereby indirectly controlling the clamping or releasing of the tricuspid annulus. This operation is repetitive and can ensure that the operator repeatedly adjusts the annulus clamp 32, so that the annulus clamp 32 obtains an optimal clamping position. And when the clamping of the tricuspid annulus is completed, the clamp 41 can be detached from the clamping system 3. When needed again, the magnetic attraction can be used to quickly connect to the locking structure 33 on the clamping system 3. A return spring is provided between the two clamps 41, which always provides tension to the jaws. By pulling the guide wire 14, the clamp 41 closes when it is inside the catheter, and the clamp 41 opens when it is outside the catheter.

[0045] The secondary adjustment system 6 is used to adjust the shape of the forming ring again when, after the forming ring is successfully placed and related evaluations such as postoperative echocardiography are used and it is found that the forming effect is not ideal. This system improves the fault tolerance rate of the overall system and reduces the operation difficulty of the whole set of systems.

[0046] The metal tying ring device 63 in the secondary adjustment system 6 is made of a metal material with plasticity and superelasticity, and the metal tying ring device 63 can be tightened by pliers at the end of the delivery catheter.

[0047] The maximum diameter of the entire forming ring system 5 is much smaller than the access vessel, and different combinations of delivery catheters can be made according to different access methods, which can fully meet the operations of the operator.

[0048] Embodiment 1

[0049] See Figures 1 to 10 , the present invention provides a valve forming ring system, mainly including: a catheter delivery system 1 for delivering the clamping system 3 and the forming ring system 5, a deflection system 2 for adjusting the catheter direction, a clamping system 3 for clamping the tricuspid annulus, an operating system 4 for opening and closing and locking the clamping system, a forming ring system 5 for narrowing the opening of the tricuspid annulus, and an adjustment system 6 for secondary adjustment of the forming ring. These components are described as follows:

[0050] Catheter delivery system 1:

[0051] As Figure 1 、 2, as shown in FIGS. 6 - 10, the catheter delivery system of the present invention includes an outer sleeve 11, a middle sleeve 12, an inner sleeve 13 and the catheters of the corresponding system. The three sleeves are nested one inside the other. Among them, the outer sleeve 11 is used to deliver the middle sleeve 12 and the inner sleeve 13 to the corresponding right atrium; the middle sleeve 12 includes several ones, respectively controlling the delivery of the clamping system 3, the operating system 4 and the forming ring system 5; each middle sleeve 12 contains a corresponding catheter, which contains an operating guide wire inside, used to control the mechanical device at the distal end.

[0052] The inner diameters of the above - mentioned outer sleeve 11, middle sleeve 12 and inner sleeve 13 decrease layer by layer, and can be adjusted accordingly according to the specific surgical requirements. The maximum distance of delivery for each layer of the sleeve can also be adjusted.

[0053] Similarly, the above - mentioned three - sleeve delivery systems are independently controlled and do not interfere with each other.

[0054] Deflection system 2:

[0055] As Figure 1 、 2 shown, the deflection system 2 of the present invention includes the outer periphery of the outer sleeve 11 and the middle sleeve 12, and is used to pass through the position that needs to be bent in the human anatomical structure. The deflection of the deflection system 2 is mainly realized by the snake bone structure one 21 and the snake bone structure two 22, so as to ensure that the whole system can accurately reach the designated tricuspid regurgitation ring position and complete a series of fine operations. The snake bone structure one 21 and the snake bone structure two 22 in the above - mentioned deflection system 2 can adjust their positions according to the specific operation requirements, and can be divided into a single - layer snake bone structure and a double - layer snake bone structure according to the operation fineness. (For specific detailed structures, reference can be made to Chinese Patent: Patent Name: A Bilateral Snake Bone Structure Device, Authorization Announcement Number CN215272599U).

[0056] Clamping system 3:

[0057] As Figure 1 、 2 、3, 4, 5 shown, the clamping system 3 of the present invention includes several clips 31, which are used to clamp the regurgitant tricuspid annulus and connect the forming ring. The clip 31 includes three parts, namely, the annulus clip 32, the locking structure 33 and the forming ring clip 34. The annulus clip 32 is located at the bottom of the whole clip and is used to clamp the regurgitant annulus; the locking structure 33 is located between the annulus clip 32 and the forming ring clip 34 and is used to lock the positions of the annulus clip 32 and the forming ring clip 34; the forming ring clip 34 is located at the top, and a forming ring guide wire one 51 is strung through the middle of the forming ring clip 34 to pull the forming ring so as to play a role in shrinking the annulus.

[0058] The inner wall of the uppermost forming ring clip 34 of the above clamping system 3 is coated with a high-friction felt material 341, which can firmly clamp the guide wire 51 of the forming ring after being locked and will not slide anymore.

[0059] The tricuspid annulus clip 32 at the bottom of the clamping system 3 includes two left and right clamping arms, namely clamping arm 1 321 and clamping arm 2 322. The inner layers of the clamping arms respectively contain biological material felt sheets, designated as felt sheet 1 325 and felt sheet 2 326. The felt sheets can increase the friction between the tricuspid annulus clip 32 and the annulus tissue and improve the firmness of clamping.

[0060] The clamping arms 1 321 and 2 322 on both sides of the above tricuspid annulus clip 32 respectively contain barbed devices 323, and there are corresponding openings 324 on the corresponding other side, which can ensure that when the annulus clip 32 is closed, it penetrates through the tricuspid annulus and passes through the opening 324 to ensure the stability of the closure of the tricuspid annulus clip 32.

[0061] The upper and lower ends of the above locking structure 33 are respectively provided with joint mechanisms connected to the annulus clip 32 and the forming ring clip 34. When the locking structure 33 is closed or opened, the upper and lower forming ring clip 34 and annulus clip 32 are indirectly controlled to be closed or opened synchronously by driving the joint mechanism.

[0062] The locking structure 33 internally contains a return spring 331 connecting the two working arms 338 on both sides and a locking turntable 332 in the middle. The return spring 331 ensures that the upper forming ring clip 34 and the lower annulus clip 32 are synchronously in either the open state or the closed state. The locking structure 33 includes two corresponding working arms 338. A return spring 331 for pulling the distance between the two working arms 338 and a locking turntable 332 for adjusting the distance between the two working arms 338 are provided between the two working arms 338; the locking structure 33 is in either of the two gears of closed or open through the return spring 331. The locking turntable 332 is provided with two length states of long and short that change cyclically; the long locking turntable 332 corresponds to the open gear of the locking structure 33, and the annulus clip 32 and the forming ring clip 34 are synchronously in the open state; the short locking turntable 332 corresponds to the closed gear of the locking structure 33, and the annulus clip 32 and the forming ring clip 34 are synchronously in the closed state.

[0063] The locking turntable 332 includes locking teeth 333 provided on one side and two types of tooth grooves provided on the other side that respectively abut against the locking teeth 333; the locking teeth 333 are arranged as a rotatable cylindrical structure, and the tooth grooves are arranged as a fixed cylindrical structure; one end of the locking teeth 333 away from the tooth grooves is fixedly connected to a working arm on one side; one end of the tooth grooves away from the locking teeth 333 is fixedly connected to the working arm on the other side; in the natural state, the return spring 331 keeps the locking teeth 333 and the tooth grooves in an abutting state all the time; the locking teeth 333 can rotate actively and can alternately abut against the two types of tooth grooves in a cycle, and when abutting against the two types of tooth grooves, they respectively correspond to two alternating length states of the locking turntable 332, namely long and short; on one side of the tooth grooves along the length direction of the locking turntable 332, there is a first ejector rod 336 for abutting against the locking teeth 333 to overcome the pulling force of the return spring 331 and pull apart the distance between the locking teeth 333 and the tooth grooves; the first ejector rod 336 passes through the inside of the cylindrical tooth grooves; one end of the first ejector rod 336 away from the locking teeth 333 actively passes through the outside of the working arm; a second ejector rod 337 is arranged in parallel with the first ejector rod 336, one end of the second ejector rod 337 is fixedly connected to the working arm passing through the first ejector rod 336, and the other end of the second ejector rod 337 actively passes through the outside of the working arm on the other side.

[0064] The central locking turntable 332 includes locking teeth 333 on one side and two types of tooth grooves on the other side that are in different abutting positions with the locking teeth 333; the two types of tooth grooves are respectively a deep tooth groove 334 and a shallow tooth groove 335; the deep tooth groove 334 and the shallow tooth groove 335 are arranged alternately; the inside of the tooth grooves includes a first ejector rod 336; when the first ejector rod 336 and the second ejector rod 337 at both ends of the locking turntable 332 are pressed simultaneously and the ends exposed from the working arm, the locking teeth 333 are pushed open by the first ejector rod 336 and separated from the tooth grooves; when the first ejector rod 336 and the second ejector rod 337 at both ends are released and the ends exposed from the working arm, the return spring 331 pulls the working arms on both sides closer, and at the same time pulls the locking teeth 333 and the tooth grooves closer, and the locking teeth 333 will rotate and abut against one type of tooth groove; when the locking teeth 333 rotate and slide to abut against the deep tooth groove 334, since the length of this tooth groove is deep, the distance between both ends of the locking turntable 332 becomes shorter, and the locking structure becomes a closed state; when the locking turntable 332 is pressed at both ends again, the locking teeth 333 leave the original deep tooth groove 334, and when the locking turntable 332 is released again at both ends, the locking teeth 333 enter another shallow tooth groove 335, and since the length of this tooth groove is shallow, the distance between both ends of the locking turntable 332 becomes larger, and the locking structure 33 becomes an open state.

[0065] Operating system 4:

[0066] Such as Figure 3 、 4As shown in the figure, the operating system 4 of the present invention is used to control the clamping system 3, which includes a set of dedicated delivery catheters and a clamp 41 at the end. The size of the clamp 41 is larger than the entire clamping system 3, and it is connected to the locking structure 33 of the clamping system 3 by a magnetic attraction structure 42 and a concave-convex component 43, and can control the position, opening and closing, and locking of the clamping system 3.

[0067] In the operating system 4, a magnetic attraction structure 42 is provided between the clamp 41 and the locking structure 33, and a concave-convex component 43 for convenient positioning is provided. The clamp 41 can tightly hold the locking structure 33 of the clamping system 3 by magnetic attraction and the concave-convex structure. By operating the guide wire 14 to control the opening and closing of the clamp 41, the opening and closing of the clamping system 3 can be controlled, thereby indirectly controlling the clamping or releasing of the tricuspid annulus. This operation is repetitive and can ensure that the operator repeatedly adjusts the annulus clamp 32 to obtain an optimal clamping position for the annulus clamp 32. And when the clamping of the tricuspid annulus is completed, the clamp 41 can be detached from the clamping system 3, and when needed again, it can be quickly connected to the locking structure 33 on the clamping system 3 by magnetic attraction. A return spring is provided between the two clamps 41, which always provides tension to the jaws. By pulling the guide wire 14, the clamp 41 closes when it is inside the catheter, and the clamp 41 opens when it is outside the catheter.

[0068] Forming ring system 5

[0069] As Figure 3 、 4 、7, 8, 9 shown, the forming ring system 5 of the present invention includes a nitinol guide wire one 51 with a memory elastic function and a corresponding delivery catheter. A number of clamping systems 3 are strung on the guide wire one 51, and adjacent clamping systems 3 are pulled by forming rings to reduce the tricuspid annulus.

[0070] Adjustment system 6

[0071] As Figure 8 、 9 shown, the secondary adjustment system 6 of the present invention includes a guide wire two 62 with two small clips 61, a corresponding delivery catheter, and a tying ring device 63. When the forming ring is successfully placed and needs to be tightened again, the secondary adjustment system can be used to grab the corresponding loose forming ring guide wire one 51, pull the guide wire one 51 to shrink the forming ring, and release the tying ring device 63, thereby achieving the effect of tightening the forming ring.

[0072] The above secondary adjustment system 6 is based on the situation that after the forming ring is successfully placed and after relevant evaluations such as postoperative echocardiogram are used and it is found that the forming effect is not ideal. At this time, the secondary adjustment system 6 can be used to adjust the shape of the forming ring again. This system improves the fault tolerance rate of the overall system and reduces the operation difficulty of the whole set of systems.

[0073] The metal tie-ring device 63 in the above-mentioned secondary regulation system 6 is made of a metal material with plasticity and superelasticity, and the tie-ring device 63 can be tightened at the end of the transmission catheter by pliers.

[0074] Usage process:

[0075] See Figures 1-10 As shown, the operator uses echocardiogram or DSA (Digital Subtraction Angiography) as a guide, and uses a catheter delivery system 1 with a three-layer catheter including an outer cannula 11, a middle cannula 12, and an inner cannula 13 to deliver the entire system into the right atrium through various approaches including the internal jugular vein, femoral artery, and apical approach, etc., reaching above the regurgitant tricuspid valve. During the approach process, the deflection system 2 can be used to adjust the direction in a timely manner. If the approach adjustment angle is too large, the double-layer snake bone structure can be used to further adjust the catheter direction. When reaching the designated position, release the clip 31 in the clamping system 3. A guide wire 51 forming a forming ring passes through the clip 31; through the operation of the clamp 41 in the operating system 4, using the felt piece 325 and the barb device 323 at the end of the annuloplasty clip 32, the tricuspid annulus can be clamped better.

[0076] When it is determined that the position is appropriate, the clamp 41 in the operating system 4 clamps the locking structure 33, and presses the ejector rod 336 and the ejector rod 337 at both ends of the locking turntable 332 in the locking structure 33; so that the locking teeth 333 in the locking turntable 332 enter the deep tooth groove 334. At this time, the locking structure 33 is locked, and the annuloplasty clip 32 and the forming ring clip 34 are closed synchronously and clamped. The high-friction material 341 inside the forming ring clip 34 can ensure that the clip 31 will not slide back and forth on the forming ring. Then, a new clamping system 3 is delivered down by using the delivery catheter and sleeved on the guide wire 51 of the forming ring system. Then, the tricuspid annulus is clamped by the same method, and the clamping quantity is adjusted according to the intraoperative ultrasound situation, and finally a tricuspid annuloplasty ring is formed to play a role in reducing the tricuspid annulus.

[0077] When it is found that the clamping position is inappropriate during the operation process, the clamp 41 of the operating system 4 can be used to grab the locking structure 33 again. The magnetic attraction structure 42 and the concave-convex component 43 on both sides of the clamp 41 can quickly combine with the locking structure 33. Press / relax the ejector rod 336 and the ejector rod 337 at both ends of the locking turntable 332 in the locking structure 33 again. At this time, the locking teeth 333 in the locking turntable 332 enter from the deep tooth groove 334 into the shallow tooth groove 335. At this time, the clamping system 3 is in an open state, and the annuloplasty clip 32 and the forming ring clip 34 are opened, and the position can be adjusted. The clip 31 is adjusted to the appropriate tricuspid annulus position, and the above process can be repeated again to clamp and lock the tricuspid annulus.

[0078] When the tricuspid annulus is still relatively large, in order to further reduce the tricuspid annuloplasty ring, the secondary adjustment system 6 can be utilized. This system is delivered to the corresponding position by a delivery catheter, and two small clips 61 are released by the corresponding catheter to clamp both ends of a section of the annuloplasty guide wire one 51. Then, it is pulled by the guide wire two 62 to lift a section of the annuloplasty guide wire one 51. Subsequently, the metal ligature ring device 63 is released by the catheter to ligate the lifted part, thereby reducing the annuloplasty system 5 and ultimately eliminating valvular regurgitation.

[0079] As described above, the above are only the preferred embodiments of the present invention, and do not impose any formal or substantial limitations on the present invention. It should be noted that for those of ordinary skill in the art of this technology, without departing from the premise of the present invention, several improvements and supplements can still be made, and these improvements and supplements should also be regarded as the protection scope of the present invention. Those skilled in the art, without departing from the spirit and scope of the present invention, when making some equivalent changes such as slight modifications, decorations, and evolutions using the technical content disclosed above, are all equivalent embodiments of the present invention; at the same time, any equivalent changes, modifications, and evolutions made to the above embodiments based on the substantial technology of the present invention still fall within the scope of the technical solutions of the present invention.

Claims

1. A valve annuloplasty ring system, characterized in that, It includes a clamping system that can clamp the tricuspid annulus multiple times, an operating system for controlling the opening and closing of the clamping system, a forming ring system for reducing the opening of the tricuspid annulus, an adjustment system for secondarily adjusting the circumference and shape of the forming ring, a catheter delivery system, and a deflection system for adjusting the direction of the catheter; the catheter delivery system includes a catheter for delivering the clamping system, the operating system, the forming ring system, and the adjustment system; the forming ring system includes a forming ring, and a plurality of clamping systems are provided on the forming ring; the clamping system is provided with an annulus clip for clamping the tricuspid annulus, a locking structure, and a forming ring clip for clamping the forming ring; the locking structure includes a two-gear structure for converting the annulus clip to an open or closed state; the annulus clip can adjust its position to clamp the tricuspid annulus multiple times; the annulus clip is connected to the forming ring clip through the locking structure; a first guide wire for the forming ring that can contract the circumference of the tricuspid valve annulus by pulling is threaded through the forming ring clip; joint mechanisms are respectively provided at the upper and lower ends of the locking structure, and the locking structure is connected to the annulus clip and the forming ring clip through the joint mechanisms respectively; a two-gear structure for closing or opening is provided in the locking structure, and when the locking structure is in the closed or open state, the annulus clip and the forming ring clip are controlled to close or open synchronously by driving the joint mechanisms. The locking structure includes two corresponding working arms, a return spring for pulling the two working arms closer and a locking turntable for adjusting the distance between the two working arms are provided between the two working arms; the locking structure is in either of the two gears of closing or opening through the return spring. The locking turntable has two length states of long and short that alternate cyclically; the long locking turntable corresponds to the open gear of the locking structure, and the annulus clip and the forming ring clip are both in the open state synchronously; the short locking turntable corresponds to the closed gear of the locking structure, and the annulus clip and the forming ring clip are both in the closed state synchronously. The locking turntable includes locking teeth provided on one side and two types of tooth grooves provided on the other side that respectively abut against the locking teeth; the locking teeth are set to be rotatable and alternately abut against the two types of tooth grooves cyclically, and when abutting against the two types of tooth grooves, they respectively correspond to the two length states of long and short that alternate in the locking turntable; a first ejector rod for overcoming the pulling force of the return spring to abut against the locking teeth and pulling the distance between the locking teeth and the tooth grooves is provided along the length direction of the locking turntable on one side of the tooth groove; the end of the first ejector rod away from the locking teeth is movably threaded through the outside of one working arm; a second ejector rod is provided parallel to the first ejector rod, one end of the second ejector rod is fixedly connected to the working arm passing through the first ejector rod, and the other end of the second ejector rod is movably threaded through the outside of the other working arm.

2. The valvuloplasty annulus system according to claim 1, characterized in that The annulus clip includes two left and right clamping arms, and biomaterial felts for increasing the friction between the annulus clip and the annulus tissue and improving the clamping firmness are respectively provided on the inner sides corresponding to the two clamping arms.

3. A valve annuloplasty ring system according to claim 1, wherein The operating system includes two openable and closable clamps; movable connection structures are respectively provided between the two clamps and the two working arms of the locking structure; when the two clamps are connected to the two working arms, the two clamps respectively abut against the first ejector rod and the second ejector rod.

4. A valve annuloplasty ring system according to claim 1, wherein, The adjustment system includes a second guide wire, two clips provided on the second guide wire for clamping the first forming ring guide wire, a wire tying device for tying a knot in the first guide wire that forms a ring after being pulled, and an adjustment system delivery catheter; the second guide wire and the wire tying device are arranged in the adjustment system delivery catheter.

5. The valvuloplasty annulus system according to claim 4, characterized in that, The wire tying device is made of a metal material with plasticity and superelasticity.

6. The valvuloplasty annulus system according to claim 1, wherein The catheter delivery system includes an outer sleeve, a middle sleeve, an inner sleeve, and a catheter inside the sleeves; the outer sleeve, the middle sleeve, and the inner sleeve are structures that are nested layer by layer.

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