General purpose transcatheter aortic valve release and retrieval device

Abstract

The application discloses a general type of post-release recovery device for a transcatheter aortic valve, which comprises an outer tube, an inner tube slidingly arranged in the outer tube, a middle control connecting piece movably arranged in the inner tube, a proximal end of the middle control connecting piece connected with a tightening piece, a plurality of special connecting wires evenly arranged between the outer tube and the inner tube, one end of each of the special connecting wires being clamped with an outer wall of the inner tube, and the other ends of all the special connecting wires being connected with a distal end of the middle control connecting piece; and the special connecting wire is a medical elastic metal wire with a memory function. The application has the characteristics of simple operation, low risk, use under DSA perspective, solution of clinical pain points, no modification of the original valve, and consideration of safety, universality and economy.

Description

Technical Field

[0001] This invention relates to a universal transcatheter aortic valve release and recovery device, belonging to the field of medical device technology. Background Technology

[0002] In recent years, transcatheter aortic valve replacement (TAVR) has gradually replaced surgical procedures as the main treatment for aortic stenosis. However, TAVR still faces many technical challenges. Current TAVR procedures are quite difficult to perform, patients have complex and diverse conditions, and a single deployment may not achieve the desired result or may result in valve detachment and skipping, leading to serious complications.

[0003] Currently, clinically applied TAVR valve retrieval technologies mainly fall into two categories: One is semi-retrieval technology, which can only adjust the valve's position or partially retrieve it before complete release. Once the valve is fully released and adheres to the body's original valve annulus, effective retrieval is impossible. If valve positioning is off, severe paravalvular leakage occurs, or valve function is abnormal, secondary interventional surgery, valve-in-valve or emergency surgery are required, significantly increasing patient trauma and surgical risks. The other category consists of a few fully release retrieval products, which are mostly tied to specific valve models, lacking versatility. Different manufacturers and specifications of valves require dedicated retrieval devices, making them unsuitable for other retrieval devices and increasing equipment costs for medical institutions. Furthermore, some retrieval devices can easily cause friction damage to the vascular wall during retrieval, leading to vascular complications and further limiting their clinical application. Therefore, developing a transcatheter aortic valve release retrieval device that is simple in structure, easy to operate, capable of complete valve retrieval, highly versatile, and safe has become a pressing technical problem in the TAVR field. Summary of the Invention

[0004] The technical problem to be solved by this invention is that it solves the problem of difficulty in effectively recovering the valve after complete release in transcatheter aortic valve replacement surgery, the inability of semi-recoverable technology to solve the recovery problem after complete release, and the poor versatility of existing devices, which leads to increased equipment costs and easy damage to the vascular endothelium and causes complications.

[0005] To solve the above-mentioned technical problems, the technical solution of the present invention is to provide a universal transcatheter aortic valve release and recovery device, characterized in that it includes an outer tube, an inner tube slidably disposed within the outer tube, a central control connector movably disposed within the inner tube, a tightening member connected to the proximal end of the central control connector, and multiple dedicated connecting wires evenly distributed between the outer tube and the inner tube. One end of each dedicated connecting wire is engaged with the outer wall of the inner tube, and the other end of all dedicated connecting wires is connected to the distal end of the central control connector; the dedicated connecting wires are medical elastic metal wires with memory function.

[0006] Preferably, the outer wall of the inner tube is provided with a plurality of outer cavity grooves, and one end of each special connecting wire is provided with a protrusion, the side opposite to the protrusion abutting against the inner wall of the outer tube, and the protrusion is engaged and abutting against a corresponding outer cavity groove.

[0007] Preferably, the special connecting wire between the outer tube and the inner tube is in a multi-folded state; each side of the special connecting wire in the multi-folded state has a protrusion, and the side opposite to the protrusion abuts against the inner wall of the outer tube, and the protrusion of each special connecting wire abuts against the groove of the outer cavity.

[0008] Preferably, a plurality of cylindrical partitions with side openings are provided between the outer tube and the inner tube. Each cylindrical partition is fixed on the inner wall of the outer tube, and the side opening of each cylindrical partition faces the outer wall of the inner tube. Each cylindrical partition, together with the outer tube and the inner wall of the inner tube, forms an outer cavity. The outer cavities are evenly distributed on the inner wall of the outer tube. Each cylindrical partition has an outer cavity groove at the position where the side opening faces the outer wall of the inner tube.

[0009] Preferably, the special connecting wire is detachably connected to the valve.

[0010] Preferably, it further includes a control component for controlling the movement of the tightening member within the inner tube, the control component being connected to the proximal end of the tightening member and fixed to the proximal end of the inner tube; the outer tube is connected to a second rotary handle of the conveying system that controls its back-and-forth sliding.

[0011] Preferably, the control component includes a tightening knob and a positioning lock. An annular plate is provided on the inner wall near the end of the inner tube. An internal thread is provided on the inner wall of the inner tube near the end of the annular plate. The longitudinal cross-section of the center position of the positioning lock and the tightening knob is an I-shaped structure. The transverse cross-section of any position on the positioning lock and the tightening knob is a circular or annular structure. A through hole is provided in the middle of the positioning lock, through which the I-shaped intermediate rod passes. The I-shaped intermediate rod of the tightening knob is located in the through hole of the positioning lock, and the I-shaped intermediate rod of the tightening knob matches the through hole. The tightening knob can rotate freely in the through hole of the positioning lock. The outer side of the lower end plate of the I-shaped positioning lock is provided with an external thread that matches the internal thread on the inner tube. The lower end plate of the I-shaped tightening knob is located between the annular plate and the lower end plate of the I-shaped positioning lock. The near end of the tightening component passes through the center of the annular plate and is fixedly connected to the lower end plate of the I-shaped tightening knob. The tightening component is a spring-shaped spiral structure.

[0012] Preferably, the length of the I-shaped middle rod of the tightening knob is greater than the overall length of the positioning lock; the upper I-shaped end plate of the tightening knob and the upper I-shaped end plate of the positioning lock are both located on the near end side of the inner tube; the outer diameter of the lower I-shaped end plate of the tightening knob is greater than the inner diameter of the center of the annular plate.

[0013] Preferably, a marking block is provided on the outer wall of the outer tube or the outer wall of the inner tube, and the upper end plate of the tightening knob is a disc-shaped structure with scale markings on the circumference of the disc surface; by recording the scale before and after rotation, the rotation angle can be known, the rotation distance of the spiral structure can be obtained from the angle, and the axial movement distance of the spiral structure can be calculated by using the elastic value and material property value of the spiral structure.

[0014] Preferably, the control component further includes a handle, which is fixed to the inner tube or is the proximal portion of the inner tube.

[0015] This invention provides a transcatheter aortic valve release and recovery device, which enables complete and stable recovery of the valve after release during transcatheter aortic valve replacement surgery, simplifies the operation process, improves surgical safety and flexibility, reduces patient trauma, surgical risks and medical institution equipment investment, and meets the clinical application needs in the field of TAVR.

[0016] Compared with existing technologies, the present invention is simple to operate, has low risk, can be used under DSA fluoroscopy, solves clinical pain points, does not modify the original valve, and takes into account safety, versatility and economy. Attached Figure Description

[0017] Figure 1 This is a schematic diagram of a universal transcatheter aortic valve release and recovery device;

[0018] Figure 2 This is a schematic diagram of the cross-sections of the outer and inner tubes at their distal ends; Figure 3 This is a schematic diagram of the longitudinal section (one side wall) of the far end of the outer and inner tubes; Figure 4 This is a schematic diagram of a universal transcatheter aortic valve release recovery device in the high-position release state of the valve; Figure 5 This is a schematic diagram of a universal transcatheter aortic valve release recovery device in a low-valve release state; Figure 6 This is a schematic diagram simulating the valve release state; Figure 7 This is a schematic diagram simulating the valve recovery state; Figure 8 This is a schematic diagram showing the installation location of the control components; Figure 9 This is a schematic diagram showing the disassembled tightening knob and positioning lock; Figure 10 A schematic diagram of the top surface of the tightening knob; Figure 11 This is a schematic diagram of the structure between the special connecting wire and the inner and outer tubes, which are in a multi-folded state; Figure 12 This is a schematic diagram of the structure when the restrictive special connecting wire is removed after the outer tube is slidable. Detailed Implementation

[0019] To make the present invention more apparent and understandable, preferred embodiments are described in detail below with reference to the accompanying drawings.

[0020] This invention provides a universal transcatheter aortic valve release and retrieval device, such as... Figure 1 As shown, it includes an outer tube 4, a central control connector 1, a special connecting wire 2, a tightening component 3, and an inner tube 6, thus forming an independent retrieval assembly. It is not pre-integrated with the valve 5, and is temporarily connected during use and can be completely separated after surgery. The outer tube 4 contains the inner tube 6.

[0021] In this embodiment, multiple cylindrical partitions with side openings are provided between the outer tube 4 and the inner tube 6. Each cylindrical partition is fixed to the inner wall of the outer tube 4, and the side opening of each cylindrical partition faces the outer wall of the inner tube 6. Each cylindrical partition, the outer tube 4, and the inner tube 6 form an outer cavity 411. The outer cavities 411 are evenly distributed on the inner wall of the outer tube 4, and each outer cavity 411 has an outer cavity groove 61 on its inner wall (i.e., each cylindrical partition has an outer cavity groove 61 at the position where the side opening faces the outer wall of the inner tube 6). Figure 2 As shown, all the outer cavities 411 form an assembly ring 41. A central control connector 1 is provided inside the inner tube 6. The proximal end of the central control connector 1 is connected to a tightening member 3. Each outer cavity 411 is connected to one end of a dedicated connecting wire 2 at its location on the inner tube 6. The other end of all dedicated connecting wires 2 is connected to the distal end of the central control connector 1. Simultaneously, the dedicated connecting wires 2 at the ends of the outer cavities 411 are arranged in a multi-folded manner and are located within the outer cavities 411. Figure 3 As shown. When not in use (initial state) or just before reaching the lesion location, the special connecting wire 2 at the end of the outer cavity 411 is in a multi-folded state, and the central control connector 1 is located at the distal end of the outer tube 4.

[0022] like Figure 11As shown, the central control latching structure includes an outer cavity groove 61 located on the inner wall surface of the outer cavity 411. Each side of the multi-folded (rotary structure) dedicated connecting wire 2 has a protrusion, and each protrusion of the dedicated connecting wire 2 is located within the outer cavity groove 61. The outer cavity groove 61 locks the dedicated connecting wire 2 in place. When not in use or when the central control connector 1 is withdrawn, the dedicated connecting wire 2 is well-limited and locked, preventing it from dislodging from the outer cavity 411. The outer tube 4 can slide back and forth via the second rotating handle of the delivery system (existing valve delivery systems, such as VenusA-Plus transcatheter aortic valve delivery system from Qiming Medical, or VitaFlow Liberty Flex transcatheter valve delivery system from MicroPort CardioFlow). If the valve is successfully released, rotating the second rotating handle causes the outer tube 4 to slide backward. Figure 12 As shown, this causes the special connecting wire 2 to disengage from the outer cavity groove 61 and separate from the valve corolla. The central control connector 1 is then pulled back further, and the special connecting wire 2 is completely retracted into the inner tube 6. The special connecting wire 2 is a medical elastic metal wire with memory function.

[0023] In this embodiment, the special connecting wire 2 is made of nickel-titanium wire. Through the elasticity of the nickel-titanium wire and the pressure exerted by the multiple folds of the nickel-titanium wire on the outer tube 4 and the inner tube 6, the protruding part of the nickel-titanium wire is stuck in the outer cavity groove 61 and cannot be removed. The central control connector 1 is a cylindrical structure, and the outer diameter of the cylinder matches the inner diameter of the inner tube 6.

[0024] The invention also includes a control component connected to the rear side of the valve delivery system and to the proximal end of the tightening member 3. The control component includes a handle, a tightening knob 63, a positioning lock 62, and a tension adjustment scale, forming an independent control unit that works in conjunction with the recovery component to achieve a unified control logic for all compatible valves 5.

[0025] In this embodiment, as Figures 8-10As shown, the control component is located near the end of the inner tube 6, and the handle is fixed to the inner tube 6. An annular plate 64 is provided on the inner wall near the end of the inner tube 6. An internal thread is provided on the inner wall of the inner tube 6 near the end of the annular plate 64. The longitudinal cross-sections at the center of the positioning lock 62 and the tightening knob 63 are both I-shaped structures. The transverse cross-sections at any position on the positioning lock 62 and the tightening knob 63 are either circular or annular structures. A through hole is provided in the center of the positioning lock 62, penetrating the I-shaped intermediate rod. The I-shaped intermediate rod of the tightening knob 63 is located within the through hole of the positioning lock 62, and the I-shaped intermediate rod of the tightening knob 63 matches the through hole, allowing the tightening knob 63 to rotate freely within the through hole of the positioning lock 62. The outer side of the lower end plate of the I-shaped positioning lock 62 has an external thread that matches the internal thread on the inner tube 6. The length of the I-shaped intermediate rod of the tightening knob 63 is greater than the overall length of the positioning lock 62 (in the length direction of the I-shaped intermediate rod). Both the upper I-shaped plate of the tightening knob 63 and the upper I-shaped plate of the positioning lock 62 are located near the proximal end of the inner tube 6. The lower I-shaped plate of the tightening knob 63 is located between the annular plate 64 and the lower I-shaped plate of the positioning lock 62, and the outer diameter of the lower I-shaped plate of the tightening knob 63 is larger than the inner diameter of the center of the annular plate 64. The proximal end of the tightening member 3 passes through the center of the annular plate 64 and is fixedly connected to the lower I-shaped plate of the tightening knob 63. The tightening member 3 has a spring-like spiral structure. By rotating the tightening knob 63, the spiral structure is tightened and unfolded, thereby causing the tightening member 3 to move backward or forward. If the valve is implanted low, to avoid applying additional tension to the valve, the tightening knob 63 can be rotated in the opposite direction to dislodge the tightening member 3. If the valve needs to be retrieved, the tightening knob 63 should be rotated in the forward direction to tighten the spiral structure, causing the tightening member 3 to retract into the inner tube 6, and pulling back the nickel-titanium wire to retrieve the valve. After the tightening knob 63 adjusts the tightening member 3 to the required position, the positioning lock 62 is rotated so that the lower end plate of the positioning lock 62 presses the I-shaped lower end plate of the tightening knob 63 against the annular plate 64, thereby restricting the rotation of the tightening knob 63 and acting as a lock.

[0026] In the second embodiment, a marking block is also welded to the outer wall of the outer tube 4 or the outer wall of the inner tube 6. The upper end plate of the tightening knob 63 is a disc-shaped structure with scale markings on the circumference of the disc surface. By recording the scale before and after rotation, the angle of rotation can be known. The distance of rotation of the spiral structure can be obtained through the angle. The axial movement distance of the spiral structure can be calculated through the elastic value and material property value of the spiral structure.

[0027] In the third embodiment, the control component is provided with a rotation drive and a locking part, which can drive the tightening member to rotate in three circumferential directions and lock it in position after rotation; the overall structure, transmission and locking method of the control component are consistent with the rotation locking component of the VenusA-Plus transcatheter aortic valve delivery system of Qiming Medical.

[0028] The tightening element 3 is a spring-shaped spiral structure. The tightening element 3 is connected to the first rotating handle of the external delivery system. The first rotating handle can tighten and unfold the spiral structure. If the valve is implanted in a low position, in order not to apply additional tension to the valve, the first rotating handle of the delivery system can be rotated in the opposite direction to dislodge the tightening element 3. If the valve needs to be retrieved, the first rotating handle of the delivery system needs to be rotated in the forward direction to tighten the spiral structure. The tightening element 3 retracts into the inner tube 6 and is pulled back with the nickel-titanium wire to retrieve the valve.

[0029] In the fourth embodiment, the control component is a conventional part in the art, and its structure is consistent with the rotation locking structure of the VitaFlow Liberty Flex transcatheter valve delivery system. During operation, the control component drives the tightening member 3 to rotate. After adjusting to the target position, the control component automatically locks, restricting the rotation of the tightening member 3, thus completing the positioning and fixation.

[0030] The core technical features of this invention revolve around "independent adaptability," "corona connection adaptability," "ease of operation," and "safety and reliability." It features adaptability: the device of this invention is an independent valve retrieval system, not integrated with any manufacturer or specification of transcatheter aortic valve. It is core-adaptable to the common structure of all manufacturers' transcatheter aortic valves—the valve corona—requiring no structural modification to the original valve 5. A stable connection is achieved solely through the invention's dedicated connection structure (i.e., the aforementioned central control connector 1 and dedicated connecting wire 2) with the corona portion of various valves 5. This breaks the limitation of existing retrieval devices being bound to specific valves 5, enabling universal retrieval of valves 5 across manufacturers and specifications. The compatibility range covers all models of transcatheter aortic valves currently used clinically (including but not limited to products from manufacturers such as Qiming, Peijia, Medtronic, and MicroPort).

[0031] The process of using this invention is as follows: Take the device of the present invention, along with the valve 5, to the desired position. like Figure 4 As shown, at this time, the valve 5 is in a high-position release state. In order to ensure that the recovery device of the present invention does not exert additional force on the valve 5, the central control connector 1 is adjusted in height according to the position of the valve 5 by the action of the tightening member 3.

[0032] like Figure 5 As shown, at this time, valve 5 is in a low-position release state. The tightening member 3 pushes the central control connector 1 out of the outer tube 4, so that valve 5 is stable.

[0033] like Figure 6 As shown, when valve 5 is in the released state, the central control connector 1 extends and adjusts with the position of valve 5.

[0034] After valve 5 is successfully released, when the special connecting wire 2 needs to be removed, the outer tube 4 retracts, and the folded-back special connecting wire 2 disengages from the outer cavity 411, as follows: Figure 4 As shown, the inner tube 6 is unfolded and simultaneously retracted. Using the tightening member 3 within the inner tube 6, the position of the central control connector 1 remains unchanged (to prevent applying additional force to the valve 5), causing the special connecting wire 2 to completely exit from the assembly ring 41 of the outer cavity 411. Figure 5 , Figure 6 As shown.

[0035] like Figure 7 As shown, if valve 5 needs to be retrieved, the inner tube 6 remains stationary, the inner layer tightening member 3 is retrieved, and the central control connector 1 is pulled back under the action of the tightening member 3, causing the special connecting wire 2 to drive valve 5 to be retrieved, thereby gradually bringing valve 5 back and compressing it into the inner tube 6, as shown. Figure 7 As shown.

[0036] This connection method is compatible with valve 5 models from different manufacturers. The surface of the dedicated connecting wire 2 is smoothly polished and treated with a biocompatible coating. Its length can be flexibly adjusted according to the release position of the valve 5 through the tightening component 3, ensuring uniform transmission of tension during retrieval. The tightening component 3 connects to the inner layer of the central control unit and adopts a gear transmission structure or a threaded transmission structure. It precisely matches the dedicated connecting wire 2, enabling uniform and controllable tightening of the dedicated connecting wire 2, avoiding damage to the corolla or detachment of the valve 5 due to sudden changes in tension.

[0037] The special connecting wire 2 of this invention is connected at one end to the central control connector 1 inside the inner tube 6, and at the other end is located inside the outer cavity 411 of the outer tube 4. This allows the nickel-titanium wire (i.e., the special connecting wire 2) connecting the valve to be completely retrievable after successful valve release. Furthermore, this invention is compatible with all brands of valves on the market, functioning as a standalone system.

Claims

1. A universal transcatheter aortic valve release and retrieval device, characterized in that, It includes an outer tube (4), an inner tube (6) that slides inside the outer tube (4), a central control connector (1) that moves inside the inner tube (6), a tightening member (3) that is connected to the proximal end of the central control connector (1), and multiple special connecting wires (2) that are evenly distributed between the outer tube (4) and the inner tube (6). One end of each special connecting wire (2) is snapped into the outer wall of the inner tube (6), and the other end of all special connecting wires (2) is connected to the distal end of the central control connector (1). The special connecting wires (2) are medical elastic metal wires with memory function.

2. The universal transcatheter aortic valve release and retrieval device as described in claim 1, characterized in that, The outer wall of the inner tube (6) is provided with multiple outer cavity grooves (61). Each special connecting wire (2) has a protrusion at one end, and the side opposite to the protrusion abuts against the inner wall of the outer tube (4). The protrusion is engaged and abuts against a corresponding outer cavity groove (61).

3. A universal transcatheter aortic valve release and retrieval device as described in claim 2, characterized in that, The special connecting wire (2) between the outer tube (4) and the inner tube (6) is in a multi-folded state; each side of the special connecting wire (2) in the multi-folded state forms a protrusion, and the side opposite to the protrusion abuts against the inner wall of the outer tube (4), and the protrusion of each special connecting wire (2) abuts against the outer cavity groove (61).

4. A universal transcatheter aortic valve release and retrieval device as described in claim 2, characterized in that, Multiple cylindrical partitions with side openings are provided between the outer tube (4) and the inner tube (6). Each cylindrical partition is fixed on the inner wall of the outer tube (4). The side opening of each cylindrical partition faces the outer wall of the inner tube (6). Each cylindrical partition, together with the inner walls of the outer tube (4) and the inner tube (6), forms an outer cavity (411). The outer cavities (411) are evenly distributed on the inner wall of the outer tube (4). Each cylindrical partition has an outer cavity groove (61) at the position where the side opening faces the outer wall of the inner tube (6).

5. A universal transcatheter aortic valve release recovery device as described in claim 1, characterized in that, The special connecting wire (2) is detachably connected to the valve (5).

6. A universal transcatheter aortic valve release and retrieval device as described in claim 1, characterized in that, It also includes a control assembly for controlling the movement of the tightening member (3) within the inner tube (6), the control assembly being connected to the proximal end of the tightening member (3) and fixed to the proximal end of the inner tube (6); the outer tube (4) is connected to a second rotary handle of the conveying system that controls its back-and-forth sliding.

7. A universal transcatheter aortic valve release recovery device as described in claim 6, characterized in that, The control components include a tightening knob (63) and a positioning lock (62). An annular plate (64) is provided on the inner wall near the end of the inner tube (6). An internal thread is provided on the inner wall of the inner tube (6) near the end of the annular plate (64). The longitudinal cross-sections of the positioning lock (62) and the tightening knob (63) at their center positions are both I-shaped structures. The transverse cross-sections of any position on the positioning lock (62) and the tightening knob (63) are both circular or annular structures. A through hole is provided in the middle of the positioning lock (62) through the I-shaped intermediate rod. The I-shaped intermediate rod of the tightening knob (63) is located at the center. The position lock (62) is located in the through hole, and the I-shaped middle rod of the tightening knob (63) matches the through hole. The tightening knob (63) rotates freely in the through hole of the position lock (62). The outer side of the I-shaped lower end plate of the position lock (62) is provided with an external thread that matches the internal thread on the inner tube (6). The I-shaped lower end plate of the tightening knob (63) is located between the annular plate (64) and the I-shaped lower end plate of the position lock (62). The near end of the tightening member (3) passes through the center of the annular plate (64) and is fixedly connected to the I-shaped lower end plate of the tightening knob (63). The tightening member (3) is a spring-shaped spiral structure.

8. A universal transcatheter aortic valve release recovery device as described in claim 7, characterized in that, The length of the I-shaped middle rod of the tightening knob (63) is greater than the overall length of the positioning lock (62); the upper I-shaped plate of the tightening knob (63) and the upper I-shaped plate of the positioning lock (62) are both located on the near end side of the inner tube (6); the outer diameter of the lower I-shaped plate of the tightening knob (63) is greater than the inner diameter of the center of the annular plate (64).

9. A universal transcatheter aortic valve release recovery device as described in claim 7 or 8, characterized in that, Marking blocks are provided on the outer wall of the outer tube (4) or the outer wall of the inner tube (6). The upper end plate of the tightening knob (63) is a disc-shaped structure with scale markings on the circumference of the disc surface. By recording the scale before and after rotation, the angle of rotation can be known. The distance of rotation of the spiral structure can be obtained by the angle. The axial movement distance of the spiral structure can be calculated by the elastic value and material property value of the spiral structure.

10. A universal transcatheter aortic valve release and retrieval device as described in claim 6, characterized in that, The control assembly also includes a handle, which is fixed to the inner tube (6) or is the proximal part of the inner tube (6).

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