Implant assembly, interventional medical device and interventional medical system

Abstract

The invention provides an implant assembly, an interventional medical system and an interventional medical instrument. The implant assembly comprises a slender component, a tissue anchor and a connecting component. The elongate member includes a flexible suture having an axial length; a tissue anchor disposed at the distal end of the elongate member and configured to anchor into tissue; the connecting component is arranged at the near end of the long and thin component, and a first joint part capable of being jointed is arranged on the connecting component. The flexible suture is configured to be located within the body and the connecting member is configured to be always located outside the body during implantation of the tissue anchor within the body. By means of the design of the implant assembly, the interventional medical system and the interventional medical instrument, the possibility that surgical operation is tedious, difficult and prone to failure is greatly reduced, and the treatment effect of the surgery is guaranteed.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly to an implant assembly, an interventional medical device and an interventional medical system. Background Art

[0002] Heart diseases are one of the major health threats globally, among which heart valve diseases are the most common. For heart valve diseases caused by mitral or tricuspid valve lesions, it has become increasingly common to treat the diseased location through interventional surgery. Currently, the mainstream interventional surgery options include artificial chordae tendineae implantation, edge-to-edge repair, and annuloplasty, etc. Generally, such surgeries are performed by minimally invasive catheter technology to place various implants in the patient's body, and remote control outside the patient's body needs to be completed under the guidance of medical imaging. Since the surgical process is carried out under non-direct vision conditions, it is extremely easy for the surgical operation to be cumbersome, difficult and prone to failure due to unreasonable design of the interventional system, which may lead to obstruction of the surgery, not only affecting the treatment effect of the surgery, but even endangering the patient's life safety. Summary of the Invention

[0003] The purpose of the present invention is to provide an implant assembly, an interventional medical system and an interventional medical device, and the design of the implant assembly, the interventional medical system and the interventional medical device greatly reduces the possibility of cumbersome, difficult and prone-to-failure surgical operations, and guarantees the treatment effect of the surgery.

[0004] To achieve the above purpose, in the first aspect, the present invention provides an implant assembly, which includes:

[0005] An elongated member, which includes a flexible suture having an axial length;

[0006] A tissue anchor, disposed at the distal end of the elongated member, and the tissue anchor is configured to be anchored into tissue; and

[0007] A connecting member, disposed at the proximal end of the elongated member, and a first engaging portion capable of being engaged is provided on the connecting member; during the process of implanting the tissue anchor into the body, the flexible suture is configured to be located inside the body, and the connecting member is configured to always be located outside the body.

[0008] In the second aspect, the present invention further provides an interventional medical system, which includes:

[0009] The above-mentioned implant assembly; and

[0010] A first interventional medical device, which is configured to receive the implant assembly, and the first interventional medical device includes a first catheter and a first handle disposed at the proximal end of the first catheter;

[0011] Wherein, the tissue anchor is received at the distal end of the first catheter, the elongate member extends through the first catheter and the first handle until beyond the proximal end of the first handle, and the connecting member is located outside the proximal end of the first handle.

[0012] In a third aspect, the present invention further provides an interventional medical system, the interventional medical system comprising:

[0013] The implant assembly described above;

[0014] A second implant, the second implant being provided with a wire passage;

[0015] A second interventional medical device, the second interventional medical device comprising a second catheter and a second handle provided at the proximal end of the second catheter, the second implant being carried within the second catheter; and

[0016] A lead member configured to removably engage with the first engagement portion; the lead member is used to introduce the implant assembly into the second interventional medical device and establish a connection with the wire passage.

[0017] In a fourth aspect, the present invention further provides an interventional medical device, the interventional medical device comprising:

[0018] An elongate catheter configured to at least partially receive or engage an implant;

[0019] A temporary connector extending through the elongate catheter, the temporary connector being configured to make a temporary connection with the tissue before the implant is anchored in the tissue; and

[0020] A restricting member provided on the elongate catheter, the restricting member being configured to engage with the distal end of the temporary connector to restrict the radial offset of the temporary connector at the distal end while allowing axial movement of the temporary connector relative to the elongate catheter.

[0021] By providing a connecting member in the implant assembly and the interventional medical system provided by the present invention to shorten the length of the elongate member, not only the material cost is greatly reduced, but also the defect of the risk of infection caused by the excessive length of the part exposed outside the patient's body is further avoided. In this way, the risk of cumbersome, difficult and easily failed surgical operations caused by the too long elongate member is avoided, and the surgical treatment effect is ensured. In addition, by providing a temporary connector capable of making a temporary connection with the tissue in the interventional medical device provided by the present invention, the risk of cumbersome, difficult and easily failed surgical operations caused by the deviation of the anchoring position from the target position during the process of anchoring the implant in the tissue and resulting in repeated anchoring is avoided, thereby ensuring the surgical treatment effect. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] To more clearly illustrate the technical solutions of the embodiments of the present invention, the following will briefly introduce the accompanying drawings required for use in the embodiments. Obviously, the accompanying drawings in the following description are some embodiments of the present invention. For those of ordinary skill in the art, without creative efforts, other accompanying drawings can also be obtained based on these drawings.

[0023] Figure 1-7 Shows an overall schematic diagram of an interventional medical system and an interventional process diagram in some embodiments.

[0024] Figure 8-9 Shows a three-dimensional schematic diagram of two implant components with different structures.

[0025] Figure 10-11 Shows a schematic diagram of the state of an implant in a patient's body in the prior art.

[0026] Figure 12a-15g Shows a schematic diagram of the structure and state of the removable engagement of an implant component and a lead member through a ball head engagement cavity and a ball head connection structure.

[0027] Figure 16a-16b Shows a schematic diagram of the structure and state of the removable engagement of an implant component and a lead member through a threaded connection structure.

[0028] Figure 17a-18b Shows a schematic diagram of the structure and state of the removable engagement of an implant component and a lead member through a connection structure of a closed ring and a movable locking ring tube.

[0029] Figure 19a-19b Shows Figure 9 A schematic diagram of the structure in which the rigid traction rope has at least two marks arranged at intervals.

[0030] Figure 20a-20d Shows schematic diagrams of tissue anchors with various different structures.

[0031] Figure 21-22 Shows a schematic diagram of implanting an implant component into a valve leaf using a first interventional medical device.

[0032] Figure 23 Shows a schematic diagram of implanting an implant component with a helical coil into a papillary muscle.

[0033] Figure 24 Shows schematic diagrams of interventional medical devices in some other embodiments.

[0034] Figure 25-27b Shows Figure 24 Schematic diagrams of various structures of the limiting member in.

[0035] Figure 28a-28c shows Figure 27a various schematic diagrams of the middle limit protrusion.

[0036] Figure 29a-32d shows Figure 24 the overall schematic diagram and the implantation process schematic diagram of the intervention medical device and the implant in [[ ]] being cooperatively implanted with an anchor lock.

[0037] Figure 33 shows Figure 24-32d the cross-sectional schematic diagram of the proximal catheter in [[ ]] being a single-lumen catheter.

[0038] Figure 34-35 shows Figure 24-32d the cross-sectional view of the proximal catheter in [[ ]] being a multi-lumen catheter.

[0039] The following specific embodiments will further illustrate the present invention in conjunction with the above-mentioned drawings. Specific Embodiments

[0040] Next, the technical solutions in the embodiments of the present invention will be clearly and completely described in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the scope of protection of the present invention.

[0041] In addition, the descriptions of the following embodiments refer to the attached drawings for illustrating specific embodiments in which the present invention can be implemented. The directional terms mentioned in the present invention, for example, "up", "down", "front", "rear", "left", "right", "inside", "outside", "side", etc., are only with reference to the directions of the attached drawings. Therefore, the directional terms used are for better and clearer illustration and understanding of the present invention, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus cannot be construed as a limitation to the present invention.

[0042] It should be noted that, in order to more clearly describe the implant assembly, interventional medical device, and interventional medical system provided by the present invention, the defined terms "proximal end" and "distal end" described in the specification of the present invention are both common terms in the field of interventional medicine. Specifically, the "distal end" refers to the end far from the operator during the surgical operation, and the "proximal end" refers to the end close to the operator during the surgical operation; the direction of the rotation central axis of an object such as a cylinder or a tube is defined as the axial direction or the longitudinal axis; the circumferential direction is the direction around the axis of an object such as a cylinder or a tube (perpendicular to the axis and perpendicular to the cross-sectional radius at the same time); the radial direction is the direction along the diameter or the radius. It should be noted that, regardless of the "end" in words such as "proximal end", "distal end", "one end", "the other end", "the first end", "the second end", "the initial end", "the terminal end", "both ends", "the free end", "the upper end", and "the lower end", it not only refers to the end head, the end point, or the end face, but also includes the part that extends a certain axial distance and / or radial distance on the element to which the end head, the end point, or the end face belongs from the end head, the end point, or the end face. Unless otherwise defined, all technical and scientific terms used in the present invention have the same meaning as those commonly understood by those skilled in the technical field to which the present invention belongs. The common terms used in the specification of the present invention are only for the purpose of describing specific embodiments and should not be construed as a limitation to the present invention.

[0043] The present invention provides an interventional medical system 100 for safely and effectively implanting an implant into a patient's tissue to treat or repair the tissue. As Figure 1-7 shown, the interventional medical system 100 includes an implant assembly 2 for implanting into the tissue, a first interventional medical device 3, a second implant 4 for implanting into the patient's body, a lead member 5, and a second interventional medical device 6, and the lead member 5 can be removably engaged with the implant assembly 2.

[0044] Among them, the first interventional medical device 3 is configured to receive the implant assembly 2 to deliver and implant the implant assembly 2 to a first target position in the patient's tissue. Specifically, the first interventional medical device 3 includes a first catheter 31 and a first handle 32 provided at the proximal end of the first catheter 31; when the implant assembly 2 is loaded into the first interventional medical device 3, as Figure 1 shown, the distal end of the implant assembly 2 is received in the distal end of the first catheter 31, and the implant assembly 2 extends proximally through the first catheter 31 and the first handle 32 until the proximal end of the implant assembly 2 extends beyond the proximal end of the first handle 32. Then, the first catheter 31 of the first interventional medical device 3 is manipulated along a desired path, such as along the femoral vein (see Figure 2 ) to enter the interior of the patient's heart through a transcatheter path to deliver the implant assembly 2 to the heart tissue, such as a first target position on the mitral valve leaf. Once the implantation is completed, the first interventional medical device 3 is withdrawn and the implant assembly 2 is left; at this time, asFigure 2 As shown, the distal end of the implant assembly 2 is connected to the valve leaflet, and the proximal end of the implant assembly 2 extends out of the patient's body along the above-mentioned desired path and is always positioned outside the patient's body.

[0045] Next, outside the patient's body, the lead member 5 is joined to the proximal end of the implant assembly 2 in the manner as Figure 3a shown. Among them, the second interventional medical device 6 includes a second catheter 61 and a second handle 62 provided at the proximal end of the second catheter 61. The second implant 4 is pre-loaded at the distal end of the second catheter 61 and is provided with a wire passage 40 as Figure 3b shown for the lead member 5 or the implant assembly 2 to pass through. The lead member 5 is used to introduce the implant assembly 2 into the second interventional medical device 6 to establish a connection with the wire passage 40 of the second implant 4. When the lead member 5 is introduced into the second interventional medical device 6, for example, introduced from the distal end of the second catheter 61 and passed through the wire passage 40 of the second implant 4, and further extended through the second catheter 61 until the proximal end of the lead member 5 extends beyond the proximal end of the second handle 62, the lead will present the lead completion state as Figure 4 shown. Then, the second interventional medical device 6 is manipulated along the path of the lead member 5 and the implant assembly 2 into the heart. During the process of entering the heart, as Figure 5a shown, the second interventional medical device 6 will travel towards the distal end direction of the implant assembly 2, and the lead member 5 will necessarily be able to pull the implant assembly 2 through the wire passage 40 of the second implant 4 until the proximal end of the implant assembly 2 passes through and extends beyond the proximal end of the second handle 62, and then the lead member 5 is detached from the proximal end of the implant assembly 2 in the manner as Figure 5b shown. At this time, the implant assembly 2 and the second implant 4 are connected through the wire passage 40, and the distal end of the second catheter 61 is located near the second target position inside the heart for subsequent operations.

[0046] In some embodiments, referring to Figure 3b and Figure 6 shown, the interventional medical system 100 is used to perform chordae tendineae implantation, and the second implant 4 is an anchor lock 4a having a wire passage 40a. Thus, the anchor lock 4a is anchored at the second target position of the ventricular tissue, such as the papillary muscle, by using the second interventional medical device 6, such as the internal anchoring actuator 63. Then, the proximal end of the implant assembly 2 is pulled outside the body until the mitral valve reaches the optimal valve function, and the anchor lock 4a is actuated by using the second interventional medical device 6, such as the internal locking actuator 64, to lock the anchor lock 4a in the appropriate position of the implant assembly 2. Then, after withdrawing the second interventional medical device 6, as Figure 6As shown, the anchor lock 4a will be locked to a position adjacent the distal end of the implant assembly 2, and the proximal end of the implant assembly 2 remains outside the patient's body. Finally, a cutting tool (not shown) is introduced along the path of the implant assembly 2 to cut the implant assembly 2 near the anchor lock 4a using the cutting tool. The implant assembly 2 and the anchor lock 4a will be formed between the valve leaflet and the ventricular tissue to form an artificial chordae tendineae, thereby replacing or supplementing the natural chordae tendineae inside the heart.

[0047] In some other embodiments, referring to Figure 7 , the interventional medical system 100 is used to perform edge-to-edge repair. The second implant 4 is a locking member 4b having a wire passage 40b. Thus, when at least two implant assemblies 2 are implanted into at least two valve leaflets using the first interventional medical device 3, the locking member 4b is further delivered near the valve leaflets using the second interventional medical device 6 according to the above steps. Then, the proximal ends of at least two implant assemblies 2 are respectively pulled outside the body until the mitral valve reaches the optimal valve function, and a locking driver of another structure (not shown) inside the second interventional medical device 6 is used to actuate the locking member 4b, such as a locking driver that squeezes the locking member 4b to deform, so as to lock the locking member 4b in a suitable position of the implant assembly 2, such as a position adjacent the distal end. Then, the implant assembly 2 is cut near the second implant 4 using the above cutting tool to complete the edge-to-edge repair.

[0048] Specifically, referring to Figure 8-9 As shown, the implant assembly 2 includes an elongate member 21, a tissue anchor 22, and a connecting member 23. Among them, the elongate member 21 includes a flexible suture having an axial length. The tissue anchor 22 is disposed at the distal end of the elongate member 21 and is configured to be anchored into tissue. The connecting member 23 is disposed at the proximal end of the elongate member 21 and has a first engaging portion 230 that can be engaged. During the process of implanting the tissue anchor 22 into the body, the flexible suture is configured to be located inside the body, and the connecting member 23 is configured to always be located outside the body. Among them, the flexible suture has a locking point and a cutting point, and the locking point is located on the distal side of the cutting point for the second implant 4 to lock the implant assembly 2 at the locking point and for the cutting tool to cut the flexible suture at the cutting point, thereby cutting the flexible suture into two separated segments to move the connecting member 23 out of the body. It can be understood that the locking point and the cutting point represent the positions where the flexible suture is locked and cut, such as any position on the flexible suture, rather than referring to a fixed point or a specific structure. Moreover, the flexible suture can be one, or two or more; the material of the flexible suture can include fluoropolymers, including but not limited to PTFE and / or ePTFE, nylon, polypropylene, polyester, PVDF, silk, or other similar materials.

[0049] In view of the prior art, such as Figure 10-11As shown, whether performing artificial chordae tendineae implantation or edge-to-edge repair, the length of the suture necessarily needs to add the length of the second interventional medical device 6. At this time, the total length of the suture generally needs to be set to about 3500 mm. An overly long suture will result in a relatively long part of the suture exposed outside the patient's body during the operation, which is likely to cause contamination, thereby triggering the risk of infection for the patient and ultimately leading to the obstruction or failure of the operation. However, in the implant assembly 2 of the present invention, the length of the elongated member 21 is shortened by providing the connecting member 23. The designer can determine the length of the elongated member 21 according to the actual path range of the implanted tissue, without the need to add the length of the second interventional medical device 6. Thus, it is ensured that the part of the elongated member 21 exposed outside the body when implanted into the patient can be extremely short, not only greatly reducing the material cost, but also significantly reducing the infection risk of the operation, avoiding the risks of cumbersome operation, high difficulty and easy failure in the prior art due to the overly long elongated member, and ensuring the surgical treatment effect. In addition, the implant assembly 2 of the present invention can be independently packaged, so it is not easily restricted by the sterilization methods of the functional components of the interventional device, and any sterilization method more suitable for the artificial chordae tendineae assembly can be selected.

[0050] Certainly, considering that the implant assembly 2 is implanted into the first target position inside the heart through a transcatheter approach, the length range of the elongated member 21 can be set to 1800 mm - 2500 mm. Thus, the total length of the implant assembly 2 is shortened by nearly half compared with the implant with a full length of about 3500 mm in the prior art.

[0051] In some embodiments of the present invention, as Figure 8 shown, the entire elongated member 21 is a biocompatible flexible suture, and preferably the length range is 1800 mm - 2000 mm. At this time, the flexible suture 21 can be crimped to the distal end of the connecting member 23; and both the locking point 21a and the cutting point 21b are located in the region adjacent to the distal end of the flexible suture 21, and the locking point 21a is located on the distal side of the cutting point 21b. Considering that the material of the flexible suture is relatively soft, it is not only not easy to package, but also increases the difficulty of introducing the first interventional medical device 3. Therefore, in some other embodiments of the present invention, as Figure 9As shown, the elongated member 21 includes a flexible suture 211 and a rigid traction cord 212 joined to the proximal end of the flexible suture 211. The connecting member 23 is provided at the proximal end of the rigid traction cord 212. For example, the proximal end of the rigid traction cord 212 is crimped to the distal end of the connecting member 23. To further reduce the difficulty of introducing the first interventional medical device 3 and reduce the material cost of the implant assembly 2, the length of the rigid traction cord 212 is much greater than the length of the flexible suture 211. For example, for some applications, the preferred length range of the flexible suture 211 is 50 mm - 70 mm, and the preferred length range of the rigid traction cord 212 is 1800 mm - 2000 mm. At this time, the locking point 211a and the cutting point 211b are located in the proximal region of the flexible suture 211, and the locking point 211a is located on the distal side of the cutting point 211b. At the same time, in view of the fact that the rigid traction cord 212 in the present invention is wound by multiple strands of stainless steel wire, the distal end of the rigid traction cord 212 can be welded and sealed to form a closed distal end, and the flexible suture 211 can be radially penetrated through the gaps between the multiple strands of the rigid traction cord 212 at a distance of 2 mm - 3 mm from the closed distal end to achieve joining.

[0052] Of course, in order to ensure that the implant assembly 2 can be joined quickly and effectively to improve the convenience of the operation, generally, the radial cross-sectional dimension of the connecting member 23 is set to be larger than the radial cross-sectional dimension of the elongated member 21. For example, it is larger than the radial cross-sectional dimension of the rigid traction cord 212 joined to the connecting member 23, so that the visible dimension is larger and it is easier to set the first engaging portion 230 to achieve quick and effective assembly and disassembly with the lead member 5. Specifically, as Figure 12a-1 shown in FIG. 8, the distal end of the lead member 5 has a second engaging portion that can be removably engaged with the first engaging portion 230. Among them, the first engaging portion 230 can be, for example, Figure 12a-1 the ball head engaging cavity 230a shown in FIG. 5, Figure 16a-16b the first threaded connection portion 230b shown in FIG., or Figure 17a-18b the closed ring 230c shown in FIG. at least one of them, and the second engaging portion is correspondingly configured as Figure 12a-1 the ball head 50a shown in FIG. 5, Figure 16a-16b the second threaded connection portion 50b shown in FIG., or Figure 17a-18b the movable locking ring tube 51c shown in FIG. at least one of them. The specific structures of the first engaging portion 230 and the second engaging portion cooperating with it in multiple different embodiments will be described in detail below.

[0053] In the first embodiment, please refer to Figure 12a-12b, the connecting member 23a and the lead member 5a are removably joined by a joining method in which the ball joint cavity 230a and the ball head 50a cooperate. Among them, the connecting member 23a is generally cylindrical and is provided with a ball joint cavity 230a having at least a proximal opening and a side opening communicating with the proximal opening for the ball head 50a to be inserted and received into the ball joint cavity 230a. Specifically, the connecting member 23a is a tubular structure with a constricted proximal end. Its distal opening is used to receive the proximal end of the elongated member 21, such as the proximal end of the rigid traction rope 212, and fix it into the distal opening. The diameter D1 of its proximal opening is configured to be smaller than the inner diameter D2 of the ball joint cavity 230a. The ball head 50a can be caught by the proximal opening of the connecting member 23a and received and clamped in the ball joint cavity 230a to achieve the joining of the two. The lead member 5a includes an elongated shaft and a ball head 50a provided at the distal end of the elongated shaft. The diameter D of the ball head 50a is slightly larger than the diameter d of the elongated shaft. Further, in order to ensure that the lead member 5a can be inserted from the side opening of the ball joint cavity 230a and be caught by the proximal opening and clamped in the ball joint cavity 230a, the size of at least part of the side opening must be larger than the diameter D of the ball head 50a for the lead member 5a to be inserted into the ball joint cavity 230a as a whole from the side opening; at the same time, the diameter D of the ball head 50a is slightly smaller than the inner diameter D2 of the ball joint cavity 230a and slightly larger than the diameter D1 of the proximal opening, and the diameter d of the elongated shaft is slightly smaller than the diameter D1 of the proximal opening of the ball joint cavity 230a, so that the elongated shaft of the lead member 5a can pass through the proximal opening, and the ball head 50a is caught by the proximal opening and accommodated in the ball joint cavity 230a, thereby achieving the rapid and effective joining of the lead member 5 and the implant assembly 2. In this embodiment, the elongated shaft of the lead member 5a can be a wire.

[0054] In some embodiments, as Figure 13a shown, the number of side openings 231a of the connecting member 23a is one, and the side opening 231a is a closed opening formed by cutting from a substantially middle position of the side wall of the connecting member 23a. The closed contour formed by the closed opening can allow the ball head 50a to pass through. In use, in the manner as Figure 13b shown, the proximal end of the lead member 5a, that is, the proximal end of the elongated shaft, is inserted into the ball joint cavity 230a from the side opening 231a and passes through the proximal opening until the ball head 50a of the lead member 5a enters and is clamped into the ball joint cavity 230a to complete the rapid joining of the two. The state diagram after joining can be referred to 13c.

[0055] In other embodiments, as Figure 14a-14bAs shown, the number of side-end openings 232a of the connecting member 23a is one, and the side-end opening 232a is cut from the proximal opening of the connecting member 23a along the side wall to approximately the middle position to form an unclosed opening communicating with the proximal opening. Among them, as Figure 14b shown, the unclosed opening 232a is an irregular opening with a larger distal size and a smaller proximal size, and the unclosed contour formed by its distal size can allow the ball head 50a to pass through, while the unclosed contour formed by its proximal size can allow the slender shaft of the connecting member 23a to pass through but not the ball head 50a. In use, in accordance with Figure 14c shown, the ball head 50a of the lead member 5a is inserted into the ball head engagement cavity 230a from the distal end of the unclosed opening 232a. Then, in accordance with Figure 14d shown, after the ball head 50a is stuffed into a part of the distal end inside the ball head engagement cavity 230a, the slender shaft of the connecting member 23a is horizontally pressed into the ball head engagement cavity 230a from the unclosed opening 232a, and the ball head 50a is pulled to the proximal opening of the connecting member 23a and clamped into the ball head engagement cavity 230a to complete the engagement as Figure 14e shown.

[0056] In other embodiments, as Figure 15a-15c shown, the number of side-end openings of the connecting member 23a is two, including a first side-end opening 233a and a second side-end opening 234a which are oppositely arranged. As Figure 15b shown, the first side-end opening 233a is a closed opening formed by cutting from a position adjacent to the proximal end of the side wall of the connecting member 23a, and the closed contour formed by the closed opening can allow the ball head 50a to pass through. As Figure 15c shown, the second side-end opening 234a is formed on the opposite side wall of the connecting member 23a and is cut from the proximal opening of the connecting member 23a along the side wall to approximately the middle position to form an unclosed opening communicating with the proximal opening. Among them, the unclosed opening 234a is an irregular opening with a larger distal size and a smaller proximal size, and the unclosed contour formed by it can allow the slender shaft of the connecting member 23a to pass through but not the ball head 50a. In use, in accordance with Figure 15d shown, the proximal end of the lead member 5a, that is, the proximal end of the slender shaft, is inserted through the first side-end opening 233a and out of the second side-end opening 234a to vertically pass through the connecting member 23a until the ball head 50a is received into the ball head engagement cavity 230a, as Figure 15e shown. Then, with the ball head 50a as the rotation center and in accordance with Figure 15f shown, the slender shaft of the lead member 5a is horizontally pressed into the ball head engagement cavity 230a from the second side-end opening 234a. Finally, the ball head 50a is pulled to the proximal opening of the connecting member 23a and clamped into the ball head engagement cavity 230a to complete the engagement as Figure 15gThe joint shown.

[0057] In the second embodiment, refer to Figure 16a-16b , the connecting member 23b and the lead member 5b are removably joined by the engagement of the first threaded connection portion 230b and the second threaded connection portion 50b. Specifically, the first threaded connection portion 230b is an external thread formed at the proximal end of the connecting member 23b, and the second threaded connection portion 50b is an internal thread formed at the distal end of the lead member 5b. The external thread and the internal thread cooperate to achieve a removable joint. Of course, the first threaded connection portion 230b can also be an internal thread, and the second threaded connection portion 50b can be an external thread, which will not be elaborated here. In this embodiment, the slender shaft of the lead member 5b can be a stainless steel wire rope.

[0058] In the third embodiment, refer to Figure 17a-18b shown, the connecting member 23c and the lead member 5c are removably joined by the cooperation of the closed loop 230c and the open loop 50c, and a movable locking loop tube 51c is used to switch between the locking loop and the disengaging loop to achieve the removable joint. Specifically, as Figure 17a shown, the connecting member 23c includes a cylindrical metal connecting body 231c and a closed loop 230c formed at the proximal end of the connecting body 231c. For example, the closed loop 230c is fixedly connected to the proximal end of the connecting body 231c by folding a metal wire in half and then crimping, welding or gluing the two free ends. Of course, for some applications, the connecting member 23c may not include the connecting body 231c, but directly form a closed loop 230c and directly fixedly connect it to the proximal end of the slender member 21. As Figure 17b shown, the lead member 5c includes a slender shaft 52c and a braided wire 53c connected to the distal end of the slender shaft 52c. Among them, the slender shaft 52c is a stainless steel wire rope. In view of the fact that the braided wire 53c is wound by multiple thin wires, the stainless steel wire rope 52c can be inserted into the braided wire 53c and glued to fix the two. And, the movable locking loop tube 51c is a PI tube or other polymer tube; preferably, as Figure 17c shown, the movable locking loop tube 51c is sleeved outside the lead member 5c and can axially move relative to the lead member 5c. Of course, in other embodiments, the movable locking loop tube 51c is sleeved outside the implant assembly 2 and can axially move relative to the implant assembly 2. When in use, as Figure 18a shown, first pass the braided wire 53c at the distal end of the lead member 5c into the closed loop 230c of the connecting member 23c and fold it in half to form an open loop 50c, and then push the movable locking loop tube 51c distally to squeeze the open loop 50c formed after folding, and then lock it into the movable locking loop tube 51c under the frictional force of the movable locking loop tube 51c, as Figure 18bAs shown. Preferably, the movable locking ring tube 51c has a certain axial length to wrap at least most of the connecting member 23c and the braided wire 53c, so as to reduce the frictional force. Withdraw the movable locking ring tube 51c proximally to completely expose the squeezed open ring 50c from within the movable locking ring tube 51c to complete the disassembly and separation of the two.

[0059] Furthermore, please refer to Figure 19a-19b , in order to ensure that the doctor can observe the adjustment condition of the implant assembly 2 through medical images during the operation, at least two marks are spaced on the rigid traction rope 212 of the present invention, such as Figure 19a shown as at least two radio-opaque marks 214a (i.e., imaging marks) spaced at the distal end of the rigid traction rope 212, and Figure 19b shown as at least two visual marks 214b spaced at the proximal end of the rigid traction rope 212. Specifically, the radio-opaque marks 214a can be formed by the method of crimping the imaging ring, while the visual marks 214b can be formed by the method of laser marking.

[0060] In particular, please refer to Figure 20a-20d , the tissue anchor 22 comprises a biocompatible material, such as stainless steel 316LVM. For some applications, the tissue anchor 22 can be Figure 20a shown as the metal tubular member 22a as shown in Figure 20b the barbed expandable anchor 22b as shown in Figure 20c the braided expandable anchor 22c as shown in Figure 20d the spiral anchor 22d as shown in

[0061] Figure 21 Figure 21As shown, the metal tubular member 22a will be received at the distal end of the first catheter 31, and the elongate member 21 extends through the first catheter 31 and the first handle 32 until it extends beyond the proximal end of the first handle 32. Moreover, the connecting member 23 extends beyond the proximal end of the first handle 32 and is located outside the proximal end of the first handle 32. Specifically, the first interventional medical device 3 further includes a puncture needle 33, which is carried within the first catheter 31 and extends through the first catheter 31 until the first handle 32, and the implant assembly 2 will be carried within the puncture needle 33. Of course, in order to push out the metal tubular member 22a from the puncture needle 33, a push tube 34 is also carried within the puncture needle 33. The push tube 34 is positioned on the proximal side of the metal tubular member 22a and has a hollow channel for the axial passage of the elongate member 21. When the puncture needle 33 pierces the valve leaflet in the manner as Figure 22 shown, the push tube 34 is further driven to push out the distal end of the metal tubular member 22a from the puncture needle 33. For some other applications, for example, first use the first interventional medical device 3 to anchor the spiral anchor 22d to the papillary muscle inside the heart (see Figure 23 ), and then use the second implant 4 to fix the other end of the implant assembly 2 to the valve leaflet inside the heart to form an artificial chordae tendineae. At this time, an anchoring actuator for driving the spiral advancement of the spiral anchor 22d (not shown in the figure) is configured within the first interventional medical device 3.

[0062] In addition, whether it is the implant assembly 2 or the second implant 4, they are hereinafter collectively referred to as the implant 1. In view of the fact that during the process of anchoring the implant 1 into the tissue, it is extremely easy to slip out of the target position due to the tissue being too smooth, which may lead to the deviation of the anchoring position from the target position, resulting in risks such as cumbersome surgical operations, high difficulty, and easy failure caused by repeated anchoring. In order to avoid the above risks and effectively ensure the surgical effect, as Figure 24 shown, the present invention further provides an interventional medical device 7, which includes an elongate catheter 71, a temporary connector 72 extending through the elongate catheter 71, and a restricting member 73 provided on the elongate catheter 71. Among them, the elongate catheter 71 is configured to at least partially receive or engage the implant 1, and the size of the elongate catheter 71 is suitable for insertion into a blood vessel. The temporary connector 72 is configured to make a temporary connection with the tissue before the implant 1 is anchored into the tissue. Specifically, the restricting member 73 is configured to at least engage with the distal end of the temporary connector 72 to restrict the radial offset of the temporary connector 72 at the distal end, while allowing the axial movement of the temporary connector 72 relative to the elongate catheter 71. Thus, before the implant 1 is anchored into the tissue, the temporary connector 72 is driven to axially move distally relative to the elongate catheter 71 until it extends beyond the distal end of the elongate catheter 71 and makes a temporary connection with the tissue. After the implant 1 is anchored into the tissue, the temporary connector 72 is further driven to axially move proximally to retract into the distal end of the elongate catheter 71. It can be understood that Figure 24The implant 1 shown does not constitute a limitation on the specific structure of the implant 1. In some embodiments, the temporary connector 72 is an elongated positioning needle having a certain axial length, and the implant 1 has a helical coil. The temporary connection of the temporary connector 72 can also resist the rotational force transmitted from the elongated catheter 71 during the anchoring of the helical coil, so as to maintain the position of the helical coil, thereby ensuring the stability when the helical coil is anchored.

[0063] Specifically, as Figure 25-26 shown, the limiting member 73 includes a first limiting member 73a and a second limiting member 73b respectively disposed on the distal tube wall of the elongated catheter 71. The first limiting member 73a and the second limiting member 73b both have an axial length and are axially connected. At the same time, the first limiting member 73a and the second limiting member 73b enclose an axially extending limiting channel 730, for example, enclose a limiting channel 730 having at least two different cross-sections, so as to allow the distal end of the temporary connector 72 to be received to limit the radial offset of the temporary connector 72, but can axially move beyond or retract into the limiting channel 730. Of course, for some applications, such as Figure 26 , the limiting member 73 further includes a hollow tube 73c fixedly disposed at least distally in the limiting channel 730, and the temporary connector 72 is movably inserted through the hollow tube 73c. Among them, the temporary connector 72 extends through the hollow tube 73c and is radially limited by the hollow tube 73c but can axially move relative to the hollow tube 73c. Specifically, the distal end of the hollow tube 73c is fixedly bonded to the limiting channel 730 by glue and further extends through the elongated catheter 71 to the proximal end. Generally, the limiting member 73 is provided with one. For the sake of clearly showing each component of the limiting member 73, Figure 26 two limiting members 73 are shown, which does not constitute a limitation on the number of limiting members 73. In some embodiments, the hollow tube 73c is made of a polymer material, such as a polyimide tube, that is, a PI tube.

[0064] In some embodiments, the limiting member 73 is disposed at the distal end of the elongated catheter 71. For example, the elongated catheter 71 includes an elongated proximal catheter 71a and a distal catheter 71b with both inner and outer diameters increasing, and the limiting member 73 is disposed on the distal catheter 71b. For some applications, the limiting member 73 extends from the distal opening 710 of the distal catheter 71b (that is, the distal opening 710 of the elongated catheter 71) along the tube wall to a position adjacent to the middle. For other applications, the limiting member 73 extends from the distal opening 710 of the distal catheter 71b along the tube wall to a position adjacent to the proximal end.

[0065] Furthermore, as Figure 27aAs shown, the first limiting member 73a includes a slot 731a formed in the distal wall of the elongated catheter 71, such as the distal catheter 71b. The proximal end of the second limiting member 73b is connected to the distal end of the slot 731a. The second limiting member 73b includes a groove 731b formed by recessing outward from the inner wall of the elongated catheter 71. The groove 731b communicates with the slot 731a and the distal opening 710 of the elongated catheter 71. In some embodiments, the groove 731b is designed as a C-shaped groove, and the axial length of the C-shaped groove is 3 mm. It is formed in the distal thickened end of the distal catheter 71b. For example, the thickness of the distal thickened end is 0.40 mm. That is, the outer diameter of the elongated catheter 71 provided with the groove 731b (i.e., the distal catheter 71b) is greater than the outer diameter of the elongated catheter 71 provided with the slot 731a (i.e., the proximal catheter 71a), so that the hollow tube 73c will not be axially misaligned or displaced when fixed to the limiting member 73. The slot 731a is designed as a hollow elongated slot, and its axial length is 12.5 mm. The distal end of the hollow tube 73c is fixed to the C-shaped groove and the hollow elongated slot by glue, so that the hollow tube 73c can be fixed in the limiting channel 730. Of course, in order to ensure that the hollow tube 73c can be safely and stably fixed, for some applications, the first limiting member 73a further includes a limiting protrusion 732a radially protruding from the inner wall of the slot 731a. The axial length of the limiting protrusion 732a is less than the axial length of the slot 731a, and there are gaps between the distal and proximal ends of the slot 731a, such as the proximal gap S1 and the distal gap S2. The distal end of the hollow tube 73c can pass through the proximal gap S1 out of the elongated catheter 71 and enter through the distal gap S2 to extend through the first limiting member 73a. Then the end of the hollow tube 73c will be positioned within the second limiting member 73b. Thus, the distal end of the hollow tube 73C will be bonded to the outside of the limiting protrusion 732a within the slot 731a and within the C-shaped groove. After the fixation is completed, the outermost distal end of the hollow tube 73c is flush with the outermost distal end of the elongated catheter 71. At this time, please refer to Figure 27b , the fixation of the hollow tube 73c to the first limiting member 73a will deviate outward from the elongated catheter 71 under the limitation of the limiting protrusion 732a. Even if the glue of the hollow tube 73c comes off, it still cannot affect the inner space of the elongated catheter 71, thereby avoiding interference with the implant 1 in the inner space and affecting the implantation effect.

[0066] It can be understood that, in order to avoid interference between the hollow tube 73c and the implant 1 and further reduce the interference of the hollow tube 73c on instruments or tissues other than the elongated catheter 71, please refer to again Figure 26-27. The radial thickness of the limiting protrusion 732a is less than that of the slot 731a, and the limiting protrusion 732a is disposed adjacent to the inner side of the slot 731a and does not extend beyond the outer side of the slot 731a. Wherein, the radial thickness of the slot 731a is the wall thickness of the distal catheter 71b, for example, 0.25 mm. In addition, the number of the limiting protrusions 732a can be one, two or more. For example, in the embodiment as shown in Figure 28a a limiting protrusion 7321a is formed at the middle position of the slot 731a and connected to the upper side wall and the lower side wall of the slot 731a. In the embodiment as shown in Figure 28b-28c at least two limiting protrusions are formed on the opposite inner walls of the slot 731a symmetrically or offset from each other. Specifically, in the embodiment as shown in Figure 28b two limiting protrusions 7322a are symmetrically formed at the approximate middle positions of the upper and lower side walls of the slot 731a. At this time, the axial length of each limiting protrusion 7322a is 6.65 mm and the radial thickness is 0.08 mm. While in the embodiment as shown in Figure 28c three limiting protrusions 7323a are formed at the approximate middle positions of the upper and lower side walls of the slot 731a offset from each other. At this time, the axial length of each limiting protrusion 7323a is 2 mm and the radial thickness is 0.08 mm.

[0067] As shown in Figure 29a-31 in this embodiment, the implant 1 is taken as an example of the anchor lock member for illustration. At this time, the interventional medical device 7 can correspond to the second interventional medical device 6. The interventional medical device 7 further includes a handle 74 (corresponding to the second handle 62), an anchoring actuator 75 (corresponding to the anchoring actuator 63) and a locking actuator 76 (corresponding to the locking actuator 64). The anchor lock member 1 has an anchoring portion 11 and a wire locking portion 12. The implant assembly 2 can be threaded through the wire passing channel of the wire locking portion 12 through the lead member 5 and extend proximally through the elongate catheter 71 and then be coupled to the wire adjusting drive mechanism 741 of the handle 74; while, the distal end of the temporary connector 72 can be removably engaged to the limiting member 73, and its proximal end extends through the elongate catheter 71 and then is coupled to the positioning pin drive mechanism 742 of the handle 74. At the same time, the distal end of the anchoring actuator 75 can be removably engaged to the proximal end of the implant 1, for example, engaged to the proximal end of the anchoring portion 11. The proximal end of the anchoring actuator 75 extends through the elongate catheter 71 and then is coupled to the anchoring drive mechanism 743 of the handle 74; while, the distal end of the locking actuator 76 can be removably engaged to the wire locking portion 12, and its proximal end extends through the elongate catheter 71 and then is coupled to the locking drive mechanism 744 of the handle 74. Of course, the interventional medical device 7 also has a bending adjustment function, and it uses a bending adjustment drive mechanism 745 to adjust the bending of the distal portion of the elongate catheter 71.

[0068] Then, as shown in Figure 32aAs shown, after the distal end of the slender catheter 71 has been brought into contact with the tissue, first, the positioning needle driving mechanism 742 is manipulated to drive the temporary connector 72 to move axially along the slender catheter 71 to extend out of its distal opening 710 and penetrate into the tissue such as the papillary muscle for positioning. Then, as Figure 32b shown, the anchoring driving mechanism 743 is manipulated to activate the anchoring actuator 75, and then drive the anchoring portion 11 to screw and extend out of the distal opening 710 of the slender catheter 71 to be anchored into the tissue. Once the anchoring is completed, as Figure 32c shown, the positioning needle driving mechanism 742 is manipulated again to retract the temporary connector 72 into the slender catheter 71. Then, the wire adjusting driving mechanism 741 is manipulated to adjust the implant assembly 2, i.e., the artificial chordae tendineae, to achieve the optimal valve function. After that, as Figure 32d shown, the locking driving mechanism 744 is manipulated to activate the movement of the locking actuator 76, and then drive the wire locking portion 12 to lock the flexible suture at the locking point 211a of the implant assembly 2.

[0069] In addition, for some applications, as Figure 33 shown, the proximal catheter 71a is a single-lumen catheter, and the inner lumen of the single-lumen catheter can simultaneously accommodate the temporary connector 72, the anchoring actuator 75, the locking actuator 76, and the implant assembly 2 or the lead member 5. Among them, the temporary connector 72, the locking actuator 76, and the implant assembly 2 are each provided with a hollow tube for them to be respectively accommodated in the hollow tube and extend side by side through the proximal catheter 71a, thereby effectively avoiding mutual interference between them. For other applications, as Figure 34-35 shown, the proximal catheter 71a is provided as a multi-lumen catheter to reduce the mutual interference between the above components, that is, the proximal catheter 71a includes at least two spaced-apart channels, namely a central channel 711a located at the central position of the proximal catheter 71a and at least one peripheral channel 712a circumferentially spaced around the central channel 711a, for respectively accommodating the temporary connector 72, the anchoring actuator 75, the locking actuator 76, and the implant assembly 2 or the lead member 5. Among them, the number of the peripheral channels 712a is 1 - 4, the cross-section of the peripheral channel 712a can be circular, square, or other irregular shapes, etc., and the arrangement of the peripheral channels 712a can be defined according to requirements. In this embodiment, the peripheral channel 712a is preferably a circular channel, the anchoring actuator 75 is accommodated in the central channel 711a, and the temporary connector 72, the locking actuator 76, and the implant assembly 2 are either accommodated in the central channel 711a together with the anchoring actuator 75 according to the number of channels of the peripheral channel 712a, or separately accommodated in the peripheral channel 712a. Given that the locking actuator 76 is a folded traction rope, two parallel peripheral channels 712a can be provided to respectively accommodate the two folded traction ropes.

[0070] The above is the implementation manner of the embodiment of the present invention. It should be noted that for those of ordinary skill in the art, without departing from the principle of the embodiment of the present invention, several improvements and refinements can still be made, and these improvements and refinements are also regarded as the protection scope of the present invention. The above is the implementation manner of the embodiment of the present invention. It should be noted that for those of ordinary skill in the art, without departing from the principle of the embodiment of the present invention, several improvements and refinements can still be made, and these improvements and refinements are also regarded as the protection scope of the present invention.

Claims

1. An implant component, characterized in that, Comprising: An elongated member including a flexible suture having an axial length; A tissue anchor disposed at a distal end of the elongated member, the tissue anchor being configured to be anchored into tissue; And A connection member disposed at a proximal end of the elongated member, the connection member having a first engaging portion that can be engaged; During the process of implanting the tissue anchor into the body, the flexible suture is configured to be located within the body, and the connection member is configured to always be located outside the body.

2. The implant assembly according to claim 1, wherein The length of the elongated member ranges from 1800 mm to 2500 mm.

3. The implant assembly according to claim 1, wherein, The radial cross-sectional dimension of the connection member is larger than the radial cross-sectional dimension of the elongated member.

4. The implant assembly according to claim 1, wherein The flexible suture has a locking point and a cutting point, and the locking point is located on the distal side of the cutting point.

5. The implant assembly according to claim 1, wherein, The first engaging portion is at least one of a ball head engaging cavity, a first threaded connection portion, or a closed ring.

6. The implant assembly according to claim 1, wherein, The elongated member further includes a rigid traction cord joined to the proximal end of the flexible suture, and the connection member is disposed at the proximal end of the rigid traction cord.

7. The implant assembly according to claim 6, wherein The length of the rigid traction cord is greater than the length of the flexible suture; the length of the flexible suture ranges from 50 mm to 70 mm, and the length of the rigid traction cord ranges from 1800 mm to 2000 mm.

8. The implant assembly according to claim 6, wherein, At least two marks are spaced apart on the rigid traction cord.

9. The implant assembly according to claim 8, wherein, The at least two marks include at least one of at least two radio-opaque marks spaced apart at the distal end of the rigid traction cord and at least two visible marks spaced apart at the proximal end of the rigid traction cord.

10. An interventional medical system, characterized in that, Comprising: The implant assembly according to any one of claims 1-9; And A first interventional medical device configured to receive the implant assembly, the first interventional medical device including a first catheter and a first handle disposed at the proximal end of the first catheter; Wherein, the tissue anchor is received in the distal end of the first catheter, the elongated member extends through the first catheter and the first handle until beyond the proximal end of the first handle, and the connection member is located outside the proximal end of the first handle.

11. The interventional medical system according to claim 10, wherein The first interventional medical device further includes a puncture needle carried within the first catheter and extending through the first catheter to the first handle for carrying the implant assembly.

12. The interventional medical system according to claim 11, wherein The first interventional medical device further includes a push tube carried within the puncture needle, the push tube being positioned on the proximal side of the tissue anchor and having a hollow channel for the elongated member to pass through.

13. An interventional medical system, characterized in that, Comprising: The implant assembly according to any one of claims 1-9; A second implant having a wire passage; A second interventional medical device including a second catheter and a second handle disposed at the proximal end of the second catheter, the second implant being carried within the second catheter; And A lead member configured to be removably engaged with the first engaging portion; the lead member is used to introduce the implant assembly into the second interventional medical device and connect it to the wire passage.

14. The interventional medical system according to claim 13, wherein, The distal end of the lead member has a second engaging portion removably engageable with the first engaging portion, and the second engaging portion is at least one of a ball head, a second threaded connection portion, or a movable locking ring tube.

15. An interventional medical device, characterized in that, Comprising: An elongate catheter configured to at least partially receive or engage an implant; A temporary connector extending through the elongate catheter and configured to make a temporary connection with the tissue before the implant is anchored in the tissue; And A restricting member disposed on the elongate catheter and configured to engage with the distal end of the temporary connector to restrict radial displacement of the temporary connector at the distal end while allowing axial movement of the temporary connector relative to the elongate catheter.

16. The interventional medical device according to claim 15, wherein, The restricting member includes a first restricting member and a second restricting member respectively disposed on the distal end wall of the elongate catheter, and both the first restricting member and the second restricting member have an axial length and are axially connected.

17. The interventional medical device according to claim 16, wherein, The first restricting member and the second restricting member enclose to form a restricting channel having at least two different cross-sections.

18. The interventional medical device according to claim 17, wherein The restricting member further includes a hollow tube fixedly disposed at least distally in the restricting channel, and the temporary connector is movably inserted through the hollow tube.

19. The interventional medical device according to claim 16, wherein The first restricting member includes a slot formed in the distal end wall of the elongate catheter, and the proximal end of the second restricting member is connected to the distal end of the slot.

20. The interventional medical device according to claim 19, wherein, The second restricting member includes a groove formed by recessing outward from the inner wall of the elongate catheter, and the groove communicates with the slot and the distal opening of the elongate catheter.

21. The interventional medical device according to claim 19, wherein, The first restricting member further includes a limiting protrusion radially protruding from the inner wall of the slot, and the axial length of the limiting protrusion is less than the axial length of the slot, and gaps are formed between the limiting protrusion and both the distal end and the proximal end of the slot.

22. The interventional medical device according to claim 21, wherein, At least two of the limiting protrusions are formed symmetrically or offset from each other on opposite inner walls of the slot, and the radial thickness of each limiting protrusion is less than the radial thickness of the slot.

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