A delivery system for a valve repair device
By designing a delivery system for the valve repair device, using the combined movement of the push assembly and multi-lumen tube, the precise adjustment of the forming ring is achieved, the problem of inaccurate position in the prior art is solved, and the safety and success rate of the surgery are improved.
Patent Information
- Application Number
- CN202210424996.3
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Filing Date
- 2022-04-21
- Publication Date
- 2025-08-05
- Estimated Expiration
- 2042-04-21
AI Technical Summary
The delivery system of the mitral annulus repair device in the prior art cannot accurately adjust when implanting the forming ring, resulting in inaccurate final position of the forming ring, which may lead to problems such as autologous leaflet tearing.
A delivery system for valve repair device is designed, including a push assembly, multi-lumen tube, outer sheath tube, tangent mechanism, wire pulling mechanism and wire pulling mechanism. Through the combined movement of the primary handle, secondary handle and tertiary handle, the precise adjustment and positioning of the valve repair device is achieved, and the rotation adjustment of the push tube and outer sheath tube is combined to ensure the optimal coordination between the forming ring and the mitral valve.
Accurate adjustment when implanting the forming ring is achieved, avoiding autologous leaflet tear, and improving the safety and success rate of the surgery.
Smart Images

Figure CN115153958B_ABST
Abstract
Description
Technical Field
[0001] The present invention relates to the technical field of medical devices, and particularly to a delivery system for a valve repair device. Background Art
[0002] Mitral annuloplasty is an important surgical method for treating mitral insufficiency. In patients with functional mitral insufficiency, due to left ventricular dilation leading to relative mitral insufficiency, such patients often do not have mitral valve lesions, and mitral annuloplasty is the main surgical method. This surgical method mainly reduces the mitral annulus opening by implanting a ring-shaped object to treat mitral insufficiency and reduce mitral regurgitation. Transcatheter mitral valvuloplasty uses a similar principle, but compared with surgical operations, transcatheter mitral valvuloplasty has the advantages of less trauma, no need for extracorporeal circulation, fewer postoperative complications, and faster postoperative recovery, but it also has its disadvantages, such as a relatively high incidence of adverse events such as myocardial infarction and coronary sinus rupture.
[0003] Since the mitral valve of the human body is not circular but D-shaped, and there are differences in the physiological structures of each person, during the transapical procedure, it is necessary to adjust the shape of the annuloplasty ring and the angle and position during implantation to ensure that the annuloplasty ring fits the autologous leaflets. In the existing technical solutions for the delivery system used in mitral valvuloplasty, during implantation, precise control cannot be achieved. However, due to the perturbations caused by cardiac pulsation, there are certain defects in whether the annuloplasty ring can finally form a predetermined semi-circular shape and whether the implants of the anchors are in place, which may lead to uneven stress and excessive stress on one or several of the anchors when finally pulling the wire to contract, resulting in tearing of the autologous leaflets. Summary of the Invention
[0004] Therefore, the technical problem to be solved by the present invention is the defect that the delivery system of the mitral annulus repair device in the prior art cannot be adjusted during the implantation of the annuloplasty ring, so as to provide a delivery system for a valve repair device.
[0005] To solve the above technical problem, the technical solution of the present invention is as follows:
[0006] A delivery system for a valve repair device, comprising:
[0007] A pushing assembly, including a primary handle, a secondary handle, and a tertiary handle arranged in sequence from proximal to distal; the secondary handle can rotate relative to the primary handle, and the tertiary handle can slide back and forth relative to the secondary handle; inside the primary handle, a multi-lumen tube fixing seat, a tangent mechanism, a wire mechanism, a pushing mechanism, and a wire pulling mechanism are arranged in sequence from distal to proximal;
[0008] The distal end of the multi-lumen tube fixing seat is connected to a multi-lumen tube, and a plurality of shaping guiding wires that pass through the inner cavity of the multi-lumen tube and are connected to the valve repair device are connected to the wire pulling mechanism;
[0009] A push button travel groove is provided on the outer wall of the primary handle; the pushing mechanism includes a pushing member disposed within the primary handle and a push rod push button connected to the pushing member and slidably connected to the push button travel groove; a pushing tube for transporting the valve repair device is fixed to the distal end of the pushing member, and the pushing tube extends distally through the multi-lumen tube fixing seat;
[0010] The wire cutting mechanism is used to cut the shaping guiding wire at the distal end of the wire pulling mechanism;
[0011] The wire pulling out mechanism is connected to a plurality of traction wires that pass through the pushing tube, and a stop pin that is sleeved on the valve repair device is connected to the traction wires;
[0012] An outer sheath tube is located on the outer periphery of the multi-lumen tube and is fixed to the distal end of the tertiary handle.
[0013] Further, a rotation groove is provided on the inner wall at the distal end of the primary handle, and a rotation boss corresponding to the rotation groove is provided on the outer side wall at the proximal end of the secondary handle, and the rotation boss can rotate on the rotation groove; a limiting block is provided on the inner wall at the distal end of the secondary handle, and a travel groove corresponding to the limiting block is provided on the inner wall at the proximal end of the tertiary handle, and the limiting block can slide on the travel groove.
[0014] Further, a main cavity and an auxiliary cavity are provided within the outer sheath tube, the multi-lumen tube is located within the main cavity, a circular cavity is provided at the center of the multi-lumen tube, and a plurality of branch cavities are provided circumferentially on the circular cavity; the pushing tube is single-lumen and is located within the circular cavity; each branch cavity allows one of the shaping guiding wires to pass through.
[0015] Further, an outer sheath fixing seat for installing the outer sheath tube is provided at the distal end of the tertiary handle, and an inner tube support seat for supporting the multi-lumen tube is provided at the proximal end of the secondary handle; the multi-lumen tube and the pushing tube extend proximally through the inner tube support seat.
[0016] Further, a connecting block is provided at the proximal end of the secondary handle, an anti-rotation boss and an eccentric hole are provided on the connecting block, a receiving groove for accommodating the connecting block is provided on the inner wall at the proximal end of the secondary handle, and a connecting groove corresponding to the anti-rotation boss is provided at the edge of the receiving groove.
[0017] Further, a multi-lumen tube blood pressure sealing piece is connected to the proximal end face of the multi-lumen tube fixing seat, and a multi-lumen tube blood sealing gasket is further provided between the multi-lumen tube fixing seat and the multi-lumen tube blood pressure sealing piece.
[0018] Further, a rivet implantation branch end is provided on the secondary handle, and a rivet fixing seat is provided at the proximal end of the rivet implantation branch end; a rivet guiding tube is provided inside the secondary handle, one end of the rivet guiding tube passes through the inner tube support seat and is connected to the outer sheath fixing seat to communicate with the auxiliary cavity; the other end of the rivet guiding tube is connected to the rivet fixing seat.
[0019] Further, a pin hole is provided at the connection between the secondary handle and the tertiary handle, and a positioning pin for locking the secondary handle and the tertiary handle is provided on the pin hole.
[0020] Further, an angle mark is provided on the outer wall at the distal end of the primary handle, and an indicating arrow for indicating the angle mark is provided on the outer wall at the proximal end of the secondary handle.
[0021] Further, the cable pulling mechanism includes:
[0022] A cable pulling sleeve, installed in the inner cavity of the primary handle, includes a first central through hole provided at the center and penetrating therethrough, and a plurality of first circumferential through holes circumferentially distributed around the first central through hole. A first wire routing channel for guiding the shaped guiding cable into the first central through hole is provided between the first central through hole and any one of the first circumferential through holes; the pushing tube is inserted into the first central through hole.
[0023] A cable guiding block, provided in the first central through hole and located at the distal end of the cable pulling sleeve, has a plurality of cable outlet holes for the shaped guiding cable to pass through, and the positions of the plurality of cable outlet holes and the plurality of first circumferential through holes are arranged in one-to-one correspondence.
[0024] Further, through cable travel grooves are provided on the side walls of the plurality of first circumferential through holes; the cable pulling mechanism further includes:
[0025] A first return spring screw, coaxially arranged in the first circumferential through hole, a cable winding disc for the shaped guiding cable to wind is connected to one end of the first return spring screw close to the cable guiding block, and a first return spring cap located at the proximal end of the cable pulling sleeve is provided at the other end of the first return spring screw.
[0026] A first screw travel nut, threadedly sleeved on the outer periphery of the first return spring screw and slidably installed on the cable travel groove; a first guiding extension block protruding outward and slidably cooperating with the cable travel groove is provided on the first screw travel nut.
[0027] The first compression spring is sleeved on the first resilient screw and is located between the first screw travel nut and the first resilient cap; the elastic force of the first compression spring drives the first screw travel nut to move towards the distal end of the first resilient screw so as to drive the first resilient screw to rotate within the first circumferential through hole, and the wire pulling turntable rotates along with the rotation of the first resilient screw so as to keep the shaping guide wire wound thereon in a tensioned state.
[0028] Further, on the cross-section perpendicular to the axial direction of the wire pulling sleeve, the connection line between the center of the first central through hole and the center of the first circumferential through hole passes through the center of the wire pulling outlet hole.
[0029] Further, a plurality of shaping guide wire outlet holes are formed in the outer wall of the first-stage handle, and a first wire locking block is arranged on the shaping guide wire outlet hole; one end of the shaping guide wire is connected to the first wire locking block and the other end is connected to the wire pulling turntable.
[0030] Further, the wire pulling mechanism includes:
[0031] A wire pulling sleeve, installed in the inner cavity of the first-stage handle, includes a second central through hole located at the center and penetrating therethrough and a plurality of second circumferential through holes circumferentially distributed around the second central through hole;
[0032] A tail-end wire splitting member, installed on the second central through hole, and one end thereof penetrates out of the second central through hole from the proximal end of the wire pulling sleeve, and a plurality of traction wire outlet holes for the traction wire to pass through are arranged thereon;
[0033] A wire pulling locking sleeve, installed on the second circumferential through hole, and one end thereof penetrates out of the second circumferential through hole from the proximal end of the wire pulling sleeve; a second wire routing channel for the traction wire inside it to extend outwards is arranged on the outer wall of the wire pulling locking sleeve; the positions of the plurality of second wire routing channels and the plurality of traction wire outlet holes are arranged in one-to-one correspondence.
[0034] Further, a through traction wire travel groove is formed in the side wall of the wire pulling locking sleeve;
[0035] A second resilient screw is coaxially arranged in the inner cavity of the wire pulling locking sleeve, a traction wire turntable for the traction wire to wind is connected to one end of the second resilient screw close to the wire pulling sleeve, and a second resilient cap located at the distal end of the wire pulling locking sleeve is arranged at the other end of the second resilient screw;
[0036] A second screw travel nut is threadedly sleeved on the outer periphery of the second resilient screw and is slidably installed in the traction wire travel groove; a traction wire guide block protruding outwards and slidably matched with the traction wire travel groove is arranged on the second screw travel nut;
[0037] A second compression spring is sleeved on the second return spring screw and is located between the second screw travel nut and the second return cap; the elastic force of the second compression spring drives the second screw travel nut to move towards the distal end of the second return spring screw so as to drive the second return spring screw to rotate in the inner cavity of the wire pulling and locking sleeve, and the traction wire turntable rotates along with the rotation of the second return spring screw so as to keep the traction wire wound thereon in a tensioned state.
[0038] Furthermore, a second central hole for the push tube to pass through is also formed in the middle of the tail end wire splitting member, and a plurality of the traction wire outlet holes are circumferentially and uniformly arranged on the outer periphery of the second central hole.
[0039] Furthermore, the tail end wire splitting member is fixed on the outer wall surface of the distal end of the wire pulling sleeve, and the traction wire outlet holes are arranged obliquely outwards from the distal end to the proximal end of the tail end wire splitting member.
[0040] Furthermore, the wire pulling and locking sleeve is slidably mounted along the axial direction of the second circumferential through hole in the second circumferential through hole, and a locking button for locking the wire pulling and locking sleeve on the second circumferential through hole is provided on the wire pulling sleeve.
[0041] Furthermore, a plurality of the traction wire outlet holes are formed in the outer wall of the first-level handle, a second wire locking block is provided on the traction wire outlet holes, and one end of the traction wire is connected to the second wire locking block and the other end is connected to the traction wire turntable.
[0042] Furthermore, the wire cutting mechanism includes:
[0043] A reinforcing tube, in which a plurality of wire passing holes extending along its axial direction are provided, and the plurality of wire passing holes are arranged along the circumferential direction of the reinforcing tube; a wire exposing groove communicated with the plurality of wire passing holes is provided on the outer peripheral wall of the reinforcing tube; a reinforcing tube central hole for the push tube to pass through is also formed in the middle of the reinforcing tube, and the plurality of wire passing holes are circumferentially and uniformly arranged on the outer periphery of the reinforcing tube central hole;
[0044] A blade fixing disc, which is fixed on the first-level handle and sleeved on the outer periphery of the reinforcing tube, and a plurality of straight guiding grooves are formed on one side edge of the blade fixing disc;
[0045] A blade turntable, which is rotatably sleeved on the outer periphery of the reinforcing tube along the axial direction of the reinforcing tube and is arranged opposite to the blade fixing disc; a plurality of arc-shaped guiding grooves are formed on the side wall of the blade turntable facing the blade fixing disc; the plurality of arc-shaped guiding grooves and the plurality of straight guiding grooves are arranged in one-to-one correspondence;
[0046] A plurality of cutting blades are located between the blade fixed disk and the blade turntable and are in the same plane as the exposed wire groove, and blade guide rods are connected thereto; one end of each blade guide rod extends into the linear guide groove and the other end extends into the corresponding arc guide groove;
[0047] During the rotation of the blade turntable, the blade guide rods of the plurality of cutting blades are simultaneously slid in the linear guide groove and the arc guide groove, so that the cutting blades approach or move away from the exposed wire groove on the reinforcing pipe.
[0048] Further, a blade edge is provided at one end of the cutting blade close to the reinforcing pipe, the blade edge is arc-shaped, and the arcs where the plurality of blade edges are located are concentrically arranged with the exposed wire groove.
[0049] Further, the cutting blade has a first arc-shaped side surface on one side of the blade edge and a second arc-shaped side surface on the other side of the blade edge; when the plurality of cutting blades extend into the exposed wire groove, the first arc-shaped side surface of the cutting blade matches the second arc-shaped side surface of an adjacent cutting blade, and the first arc-shaped side surface of the cutting blade matches the second arc-shaped side surface of another adjacent cutting blade; the cutting blade is in the shape of a propeller.
[0050] Further, a cutting button travel groove is provided on the outer wall of the first-stage handle, and a cutting button extending out of the cutting button travel groove is connected to the outer side wall of the blade turntable.
[0051] Further, the rivet guide tube is connected with a rivet implanting device; the rivet implanting device includes a rivet integral handle, a rivet pushing handle, a medical rivet, and a rivet connecting tube connected to the release buckle of the medical rivet; the rivet connecting tube extends into the rivet guide tube.
[0052] Further, the medical rivet has a shape memory function, including:
[0053] A puncture tip, located at the distal end of the medical rivet;
[0054] A rivet barb, located at one end of the side wall of the medical rivet close to the puncture tip;
[0055] A rivet avoidance groove, located on the outer side wall of the medical rivet and corresponding to the position of the rivet barb;
[0056] A release buckle, located at the proximal end of the medical rivet and used for connecting with the rivet connecting tube;
[0057] A reverse elastic block, provided at one end of the medical rivet close to the release buckle;
[0058] The rivet barb has an initial state in which it is expanded outward in a natural state and the barb on it is arranged toward the proximal end, and a loaded state in which it is retracted into the rivet avoidance groove under the action of an external force; the reverse spring block has an initial state in which it is bent outward in a natural state and expanded and the end away from the medical rivet is arranged toward the distal end, and a loaded state in which it is bent reversely toward the proximal end under the action of an external force.
[0059] Furthermore, the reverse spring block is integrally formed with the medical rivet; or the reverse spring block is at least two spring pieces welded to the outside of the medical rivet, or the reverse spring block is an arched spring piece passing through the middle of the medical rivet and welded and fixed to the medical rivet.
[0060] Furthermore, a rivet pressing piece is coaxially sleeved on the outer side of the medical rivet, and the rivet pressing piece is cylindrical; a plurality of spikes protruding outward are provided at the distal end of the rivet pressing piece.
[0061] Furthermore, the gap between the rivet pressing sheet and the medical rivet is suitable for a covering tube to pass through, an opening groove is provided at the distal end of the covering tube, and the inner side wall of the rivet pressing sheet is provided with a pressing boss that is limitedly matched with the opening groove.
[0062] Furthermore, the rivet integral handle includes a tube outlet end and a pushing end, and a pushing cavity is provided inside the pushing end; the front section of the rivet pushing handle extends into the pushing cavity and can move back and forth axially relative to the pushing cavity; a rivet connecting tube connecting cavity is provided inside the rivet pushing handle, and a rivet connecting tube fixing block is provided inside the rivet connecting tube connecting cavity, and the rivet connecting tube passes through the tube outlet end and the pushing end and is fixedly connected to the rivet connecting tube fixing block; a spring buckle is provided on the cavity wall of the pushing cavity, and a stopping boss that engages with the spring buckle is provided on the outer wall of the front section of the rivet pushing handle.
[0063] Furthermore, a coaxial sleeve is provided on the outer periphery of the rivet connecting tube, and a covering tube connecting cavity is also provided in the rivet pushing handle, the covering tube connecting cavity is located at the distal end of the rivet connecting tube connecting cavity, a covering tube connecting slider is provided in the covering tube connecting cavity, a rebound spring is provided between the covering tube connecting slider and the distal cavity wall of the covering tube connecting cavity, a spring fixing block and a release button are also provided in the covering tube connecting cavity, and the release button and the spring fixing block are elastically connected by a release spring; the covering tube connecting slider can slide back and forth relative to the covering tube connecting cavity; the rivet connecting tube passes through the covering tube connecting slider and is fixedly connected to the rivet connecting tube fixing block.
[0064] Further, a bending adjustment tube is coaxially sleeved on the outer periphery of the covering tube. The overall handle of the rivet further includes a first bending adjustment end and a second bending adjustment end that communicate with the outlet tube end. Both the first bending adjustment end and the second bending adjustment end are provided with bending adjustment cavities. A coaxial bending adjustment sliding guide rail is provided in the bending adjustment cavity. A bending control knob cap is provided at the proximal end of the bending adjustment cavity. The bending control knob cap is connected to the bending adjustment sliding guide rail. A bending control locking wire nut that is slidably connected to the inner wall of the bending adjustment cavity is threadedly connected to the outer periphery of the bending adjustment sliding guide rail. Rotating the bending control knob cap can drive the bending control locking wire nut to reciprocate axially along the bending adjustment sliding guide rail. A bending control guide wire is connected to the bending control locking wire nut, and the other end of the bending control guide wire is connected to the bending adjustment tube.
[0065] Further, a bending adjustment fixed seat is fixed at one end of the outlet tube end close to the first bending adjustment end and the second bending adjustment end. One end of the bending adjustment tube is fixedly connected to the bending adjustment fixed seat. The bending adjustment fixed seat is provided with a central hole of the bending adjustment fixed seat for the covering tube to pass through and a bending control guide wire groove for the bending control guide wire to pass through.
[0066] Further, the bending adjustment tube includes an outer layer, an intermediate layer, and an inner layer arranged in sequence from outside to inside. The bending control guide wire is arranged in the intermediate layer. The front section of the bending adjustment tube is provided with a first traction ring and a second traction ring. The bending control guide wire at the first bending adjustment end is connected to the first traction ring, and the bending control guide wire at the second bending adjustment end is connected to the second traction ring.
[0067] Further, it further includes a support platform for the delivery system for delivering the valve repair device, including a bottom plate, a rack slide rail arranged on the bottom plate, and a first support, a second support, and a third support slidably arranged on the rack slide rail. A first sleeve for installing the primary handle is provided on the first support, a second sleeve for installing the secondary handle is provided on the second support, and a third sleeve for installing the tertiary handle is provided on the third support. The first sleeve, the second sleeve, and the third sleeve are located on the same straight line.
[0068] Further, the side with teeth of the rack slide rail is inclined. The first sleeve and the second sleeve are located on the same straight line inclined to the horizontal line, and the included angle between the straight line and the horizontal line is the same as the inclination gradient of the rack slide rail.
[0069] Further, the rack slide rail is provided with a slider. The bottoms of the first support and the second support are fixed on the slider. A gear meshing with the rack slide rail is installed on the slider, and a locking member for tightly pressing against the rack slide rail is connected to the side wall of the slider.
[0070] Further, quick-lock bolts are provided on both the first sleeve, the second sleeve, and the third sleeve.
[0071] The technical solution of the present invention has the following advantages:
[0072] 1. For the delivery system of the valve repair device provided by the present invention, a primary handle, a secondary handle, and a tertiary handle are provided. The tertiary handle can slide back and forth relative to the secondary handle, and the secondary handle can rotate relative to the primary handle. By sliding the secondary handle back and forth and rotating the secondary handle, the distance between the valve repair device and the mitral valve can be adjusted, and the valve repair device can be adjusted when implanting the annuloplasty ring. A pushing mechanism is provided. A push tube for delivering the valve repair device is fixed at the distal end of the pusher. By pushing the pusher button, the push tube can be moved distally or proximally, thereby making the valve repair device close to or away from the mitral valve. The push tube passes through the multi-lumen tube fixing seat and extends distally and into the multi-lumen tube. An outer sheath tube fixed to the distal end of the tertiary handle is provided on the outer periphery of the multi-lumen tube. With such a design, the multi-lumen tube and the push tube can be pushed separately, and the outer sheath tube can be rotated to further adjust the matching degree between the annuloplasty ring and the mitral valve.
[0073] 2. For the delivery system of the valve repair device provided by the present invention, a rotation groove is provided on the inner wall at the distal end of the primary handle, and a rotation boss corresponding to the rotation groove is provided on the outer wall at the proximal end of the secondary handle, so that the rotation boss can rotate on the rotation groove. A limiting block is provided on the inner wall at the distal end of the secondary handle, and a travel groove corresponding to the limiting block is provided on the inner wall at the proximal end of the tertiary handle, so that the limiting block can slide on the travel groove. At the same time, through the limiting structure of the travel groove and the limiting block, when the secondary handle rotates, the tertiary handle will rotate together with the secondary handle, which can ensure the consistency of the movement of the tertiary handle and the secondary handle during adjustment and ensure the stability of the adjustment.
[0074] 3. For the delivery system of the valve repair device provided by the present invention, a main cavity and a secondary cavity are provided in the outer sheath tube. The multi-lumen tube is located in the main cavity. A circular cavity is provided in the center of the multi-lumen tube, and a plurality of branch cavities are provided circumferentially on the circular cavity. The push tube is single-lumen and is located in the circular cavity. Each branch cavity is for a shaping guide wire to pass through. With such a design, separating the multiple shaping guide wires one by one can avoid entanglement of multiple groups of shaping guide wires.
[0075] 4. For the delivery system of the valve repair device provided by the present invention, an anti-rotation boss and an eccentric hole are provided on the connecting block. A receiving groove for receiving the connecting block is provided on the inner wall at the proximal end of the secondary handle, and a connecting groove corresponding to the anti-rotation boss is provided at the edge of the receiving groove. With such a design, the eccentric hole of the multi-lumen tube connecting block can ensure that the multi-lumen tube and the push tube do not rotate when the outer sheath tube rotates.
[0076] 5. For the delivery system of the valve repair device provided by the present invention, a pin hole is provided at the connection between the secondary handle and the tertiary handle, and a positioning pin for locking the secondary handle and the tertiary handle is provided on the pin hole. With such a design, in the initial state, the positioning pin penetrates through the pin hole; before pushing the secondary handle, the positioning pin is pulled out, and then the secondary handle can be pushed, which is convenient for operation.
[0077] 6. For the delivery system of the valve repair device provided by the present invention, an angle mark is provided on the outer wall of the distal end of the primary handle, and an indicating arrow for indicating the angle mark is provided on the outer wall of the proximal end of the secondary handle. With such a design, since the mitral valve of the human body is not circular but D-shaped, and there are differences in the physiological structures of each person, during the transapical surgery, it is necessary to rotate the secondary handle to adjust the direction, and the rotation angle during the surgery can be conveniently observed through the angle mark.
[0078] 7. For the delivery system of the valve repair device provided by the present invention, by installing a wire sleeve in a handle, a through first central through hole and a plurality of first circumferential through holes circumferentially distributed around the first central through hole are provided in the wire sleeve, a first wire routing channel for guiding the shaping guide wire into the first central through hole is provided between the first central through hole and any one of the first circumferential through holes, a wire guiding block is provided in the first central through hole, and a plurality of wire outlet holes for the shaping guide wire to pass through and corresponding to the positions of the plurality of first circumferential through holes are provided on the wire guiding block. With such a design, multiple groups of shaping guide wires can be separated and selected for installation one by one, avoiding entanglement of multiple groups of shaping guide wires.
[0079] 8. The delivery system of the valve repair device provided by the present invention has through wire-drawing stroke grooves provided on the side walls of multiple first circumferential through holes. A first resilient screw is coaxially arranged within the first circumferential through holes. One end of the first resilient screw close to the wire-drawing guide block has a wire-drawing turntable for winding the shaping guide wire, and the other end has a first resilient cap. A first screw stroke nut is sleeved on the outer periphery of the first resilient screw. A first compression spring sleeved on the first resilient screw is arranged between the first screw stroke nut and the first resilient cap; one end of the shaping guide wire is fixed on the wire-drawing turntable. Due to the action of the first resilient spring, the first screw stroke nut is always subjected to a thrust force. After the first screw stroke nut is subjected to the thrust force, it drives the first resilient screw to rotate through screw engagement. The wire-drawing turntable rotates along with the rotation of the first resilient screw, thereby always tightening the shaping guide wire and keeping the shaping guide wire under a tension force all the time, avoiding the entanglement of multiple groups of shaping guide wires in a loose state. In addition, by adjusting the parameters of the wire-drawing device (such as the thread pitch between the first screw stroke nut and the first resilient screw, the diameter ratio between the first resilient screw and the wire-drawing turntable, and the elastic characteristic curve of the first resilient spring), the magnitude of the tension force received by the shaping guide wire can be changed. The first screw stroke nut has a first guiding extension block protruding outward and slidably mating with the wire-drawing stroke groove, which can enable the first screw stroke nut to move back and forth relative to the wire-drawing stroke groove without rotation.
[0080] 9. The delivery system of the valve repair device provided by the present invention has multiple shaping guide wire outlet holes provided on the outer wall of the first-stage handle. A first wire-locking pulling block is arranged on the shaping guide wire outlet holes. One end of the shaping guide wire is connected to the first wire-locking pulling block, and the other end is connected to the wire-drawing turntable. With such a design, after the shaping guide wire is used up, the unnecessary traction wire can be directly pulled out by pulling the wire-locking pulling block, and the operation is convenient.
[0081] 10. The delivery system of the valve repair device provided by the present invention has a traction wire guiding block protruding outward on the second screw stroke nut and slidably mating with the traction wire stroke groove. With such a design, the second screw stroke nut can move back and forth relative to the traction wire stroke groove without rotation.
[0082] 11. The delivery system of the valve repair device provided by the present invention has a tail-end wire-splitting member fixed on the outer wall surface at the distal end of the wire-pulling sleeve. The traction wire outlet hole is inclined outward from the distal end to the proximal end of the tail-end wire-splitting member. With such a design, the problem that the traction wire has a large resistance and is easily stuck when exiting at 90° can be avoided.
[0083] 12. The delivery system of the valve repair device provided by the present invention, the wire-pulling locking sleeve is slidably mounted along the axial direction of the second circumferential through-hole in the second circumferential through-hole, and a locking button for locking the wire-pulling locking sleeve on the second circumferential through-hole is provided on the wire-pulling sleeve. With such a design, the wire-pulling locking sleeve can be fixedly connected to the wire-pulling sleeve through the locking button.
[0084] 13. The delivery system of the valve repair device provided by the present invention, a plurality of traction wire outlet holes are provided on the outer wall of the handle, and a second wire-locking pull block is provided on the traction wire outlet holes. One end of the traction wire is connected to the second wire-locking pull block and the other end is connected to the traction wire turntable. With such a design, after the use of the traction wire, the unnecessary traction wire can be directly pulled out by pulling the wire-locking pull block, and the operation is convenient.
[0085] 14. The delivery system of the valve repair device provided by the present invention, by providing a reinforcing tube with a plurality of wire passing holes distributed axially, a wire exposing groove communicating with the plurality of wire passing holes is provided on the outer peripheral wall of the reinforcing tube, a blade fixing disc and a blade turntable are provided on the outer periphery of the reinforcing tube, a plurality of straight guiding grooves are provided on one side edge of the blade fixing disc, a plurality of arc-shaped guiding grooves are provided on the side wall of the blade turntable facing the blade fixing disc, the plurality of arc-shaped guiding grooves and the plurality of straight guiding grooves are arranged in one-to-one correspondence, a plurality of cutting blades are provided between the blade fixing disc and the blade turntable, the cutting blades and the wire exposing groove are located in the same plane, a blade guiding rod is connected to the cutting blade, one end of the blade guiding rod extends into the straight guiding groove and the other end extends into the corresponding arc-shaped guiding groove, during the relative rotation of the blade turntable and the blade fixing disc along the axis of the reinforcing tube, the plurality of cutting blades approach or move away from the wire exposing groove along with the movement of the blade turntable, and when the cutting blades rotate to the wire exposing groove, the plurality of wire ropes located at the wire exposing groove in the wire passing holes can be cut simultaneously; compared with the prior art in which the plurality of wire ropes connected to the implanting instrument are cut one by one, it avoids the situation that the implanting instrument is partially stressed and partially unstressed during the process of cutting the wire ropes, and further avoids problems such as tilting, displacement, and bending of the implanting instrument.
[0086] 15. The delivery system of the valve repair device provided by the present invention, an arc-shaped blade edge is provided at the end of the cutting blade close to the reinforcing tube, and the arcs where the plurality of blade edges are located are concentric with the wire exposing groove. With such a design, the blade edges can all abut against the wire exposing groove without gaps, ensuring that the blade edges completely cut the wire ropes at the wire exposing groove.
[0087] 16. The valve repair device delivery system provided by the present invention further comprises a cutting blade having a first curved side surface aligned with one side of the blade edge and a second curved side surface aligned with the other side of the blade edge. The first curved side surface mates with the second curved side surface of an adjacent cutting blade. This design provides a compact structure, allowing the sides of the multiple cutting blades to mate with each other when rotated to abut the wire-exposing groove, preventing interference that could result in failure to cut the pull wire.
[0088] 17. The delivery system of the valve repair device provided by the present invention is achieved by arranging a puncture tip at the distal end of the medical rivet, arranging a rivet barb on the side wall of the medical rivet near the puncture tip, arranging a rivet avoidance groove corresponding to the position of the rivet barb on the outer wall of the medical rivet, arranging a release buckle connected to the rivet connecting tube at the proximal end of the medical rivet, and arranging a reverse spring block at the end of the medical rivet near the release buckle; the rivet barb has an initial state of the rivet barb that is naturally expanded outward and the barb thereon is arranged toward the proximal end, and a loaded state of the rivet barb that is retracted into the rivet avoidance groove under the action of external force; the reverse spring block has an initial state of the reverse spring block that is naturally bent outward and expanded and the end away from the medical rivet is arranged toward the distal end, and a loaded state of the reverse spring block that is reversely bent toward the proximal end under the action of external force. The rivet barb provides an anchoring effect on the distal surface of the surgical site, and the reverse spring provides an anchoring effect on the proximal surface of the surgical site, thereby achieving double-sided anchoring of the surgical site, thereby strengthening the riveting strength of the medical rivet, improving the fault tolerance rate, and reducing the chance of error.
[0089] 18. The valve repair device delivery system provided by the present invention features a cylindrical rivet pressure piece coaxially sleeved on the outside of the medical rivet; the distal end of the rivet pressure piece is provided with a plurality of outwardly protruding spikes. This design securely secures the area around the surgical site punctured by the medical rivet through the spikes, preventing the puncture site from expanding and tearing when the medical rivet is pulled.
[0090] 19. The delivery system for the valve repair device provided by the present invention comprises a gap between the rivet pressing plate and the medical rivet, allowing the passage of a sheathing tube. The distal end of the sheathing tube is provided with an open slot, and the inner sidewall of the rivet pressing plate is provided with a pressing plate boss that cooperates with the open slot. This design allows the distal end to be slightly opened by the open slot, facilitating the loading of the rivet into the implant device. Simultaneously, the open slot and the pressing plate boss of the rivet pressing plate form a retaining mechanism, thereby ensuring that the rivet pressing plate moves along with the sheathing tube during its advancement and that the rivet pressing plate remains at the implant site during its release, preventing it from being removed.
[0091] 20. The delivery system of the valve repair device provided by the present invention has a snap on the wall of the pushing cavity, and a stop boss that is snap-fitted with the snap is provided on the outer wall of the front section of the rivet pushing handle. By the cooperation of the snap and the stop boss, the stop state can be maintained after the rivet is implanted, avoiding the reset of the medical rivet caused by manual operation.
[0092] 21. The delivery system of the valve repair device provided by the present invention coaxially sleeved with a covering tube on the outer periphery of the rivet connecting tube. The design of the covering tube enables the medical rivet to adjust its direction along with the bending tube during the process of being delivered to the surgical site, and provides better anti-axial compression performance and bending performance during the pushing process.
[0093] 22. The delivery system of the valve repair device provided by the present invention further has a covering tube connection cavity in the rivet pushing handle. A spring fixing block and a release button are also provided in the covering tube connection cavity. The release button is elastically connected to the spring fixing block through a release spring; the covering tube connection slider can reciprocally slide relative to the covering tube connection cavity; the rivet connecting tube passes through the covering tube connection slider and is fixedly connected to the rivet connecting tube fixing block. With such a design, through the cooperation of the covering tube and the release button, after the puncture tip passes through the surgical site, the release button is pressed, the restriction of the covering tube connection slider is released, and under the action of the release spring, the covering tube connection slider slides proximally, the covering tube connection slider drives the covering tube to displace proximally, so that the puncture tip is released from the restraint of the covering tube, and at the same time, the release buckle and the rivet connecting tube are released from the clamped and locked state and separated from each other. By directly pressing the release button during release, the release process can be made faster and more convenient, avoiding the situation of misalignment of the medical rivet when releasing the medical rivet due to manual control of the stroke.
[0094] 23. The delivery system of the valve repair device provided by the present invention coaxially sleeved with a bending tube on the outer periphery of the covering tube. The overall rivet handle further includes a first bending end and a second bending end that communicate with the outlet end; bending cavities are provided in both the first bending end and the second bending end. A bending sliding guide rail is coaxially arranged in the bending cavity. A control bending knob cap connected to the bending sliding guide rail is provided at the proximal end of the bending cavity. A control bending lock wire nut that is threadedly connected to the outer periphery of the bending sliding guide rail and slides on the inner wall of the bending cavity is provided; rotating the control bending knob cap can drive the control bending lock wire nut to reciprocally move axially along the bending sliding guide rail; a control bending guide wire is connected to the control bending lock wire nut, and the other end of the control bending guide wire is connected to the bending tube. With such a design, by rotating the first bending end and the second bending end, the bending knob cap provided in the bending cavity drives the control bending lock wire nut to reciprocally move axially along the bending sliding guide rail, and further drives the control bending guide wire connected to the control bending lock wire nut to axially reciprocally move, achieving the effect of two-way bending.
[0095] 24. The delivery system for the valve repair device provided by the present invention is provided with a base plate having a rack slide rail, on which a first support and a second support are slidably provided. A first sleeve is provided on the first support and is used to mount a primary handle of the push device. A second sleeve is provided on the second support and is used to mount a secondary handle of the push device. With this design, when the rivet is implanted, the first sleeve can rotate the primary handle, and the second sleeve can restrict the secondary handle from rotating along the central axis of the second sleeve. When the second sleeve is rotated, the first sleeve will not rotate, which is beneficial for improving the success rate of the angioplasty ring implantation surgery. The first support and the second support are arranged on the rack slide rail, so that the push device slides on a straight line formed by the first support and the second support. This can ensure the stability of the angioplasty ring device during the pushing process during the angioplasty ring intervention surgery, ensure the coordination of the angioplasty ring with the human mitral valve during the intervention, and thus improve the success rate of the intervention surgery. BRIEF DESCRIPTION OF THE DRAWINGS
[0096] In order to more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the specific embodiments or the description of the prior art. Obviously, the drawings described below are some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.
[0097] Figure 1 A diagram showing the positional relationship between the shaping guide wire and the traction wire of the valve repair device provided by the present invention;
[0098] Figure 2 A three-dimensional structural diagram of the valve repair device provided by the present invention;
[0099] Figure 3 A three-dimensional structural diagram of the delivery system of the valve repair device provided by the present invention;
[0100] Figure 4 This is a three-dimensional structural diagram of the interior of the first-level handle of the present invention;
[0101] Figure 5 Schematic diagram of the positional relationship between the multi-lumen tube blood sealing piece and the multi-lumen tube blood sealing gasket in the present invention;
[0102] Figure 6 Schematic diagram of the positional relationship between the rotating groove and the rotating boss in the present invention;
[0103] Figure 7 This is a three-dimensional structural diagram of the interior of the secondary handle of the present invention;
[0104] Figure 8 Schematic diagram of the positional relationship between the connecting block and the accommodating groove in the present invention;
[0105] Figure 9 It is a three - dimensional structure diagram inside the three - stage handle in the present invention;
[0106] Figure 10 It is a schematic diagram of the positional relationship between the limiting block and the travel groove in the present invention;
[0107] Figure 11 It is a schematic diagram of the positional relationship among the outer sheath tube, the multi - cavity tube and the push tube in the present invention;
[0108] Figure 12 It is a three - dimensional structure diagram of the positional relationship among the outer sheath tube, the multi - cavity tube and the push tube in the present invention;
[0109] Figure 13 It is a diagram of the positional relationship between the wire - pulling mechanism and the wire - extracting mechanism provided by the embodiment of the present invention;
[0110] Figure 14 It is a three - dimensional structure diagram of the wire - pulling mechanism in the present invention;
[0111] Figure 15 It is a three - dimensional structure diagram of the wire - pulling sleeve in the present invention;
[0112] Figure 16 It is a three - dimensional structure diagram of the first screw travel nut in the present invention;
[0113] Figure 17 It is a three - dimensional structure diagram of the wire - pulling guide block in the present invention;
[0114] Figure 18 It is a three - dimensional structure diagram of the wire - pulling turntable in the present invention;
[0115] Figure 19 It is a three - dimensional structure diagram of the wire - extracting mechanism in the present invention;
[0116] Figure 20 It is Figure 19 an enlarged view of part A in
[0117] Figure 21 It is a three - dimensional structure diagram of the wire - extracting sleeve in the present invention;
[0118] Figure 22 It is a three - dimensional structure diagram of the end - splitting part in the present invention;
[0119] Figure 23 It is a structural schematic diagram of the end - splitting part in the present invention;
[0120] Figure 24 It is a sectional view of A - A of the end - splitting part in the present invention;
[0121] Figure 25 It is a three - dimensional structure diagram of the wire - cutting mechanism for the intervention system provided by the present invention;
[0122] Figure 26 Schematic diagram of the internal structure of the blade fixing disc in the present invention;
[0123] Figure 27 Schematic diagram of the internal structure of the blade turntable in the present invention;
[0124] Figure 28 Stereoscopic structure diagram of the reinforcing tube in the present invention;
[0125] Figure 29 Schematic diagram of the structure of the reinforcing tube in the present invention;
[0126] Figure 30 Stereoscopic structure diagram of the medical rivet and the rivet implantation device provided by the present invention in the initial state;
[0127] Figure 31 Stereoscopic structure diagram of the medical rivet and the rivet implantation device provided by the present invention in the implanted state;
[0128] Figure 32 Stereoscopic structure diagram of the medical rivet provided by the present invention in the released state;
[0129] Figure 33 Stereoscopic structure diagram of the medical rivet in the present invention;
[0130] Figure 34 Stereoscopic structure diagram of the rivet barb and the reverse elastic block in the present invention before implantation;
[0131] Figure 35 Schematic diagram of the connection relationship between the overall rivet handle and the rivet pushing handle in the present invention;
[0132] Figure 36 Cross-sectional view of the overall rivet handle A - A in the present invention;
[0133] Figure 37 Schematic diagram of the internal structure of the bending adjustment end and the rivet pushing handle in the present invention;
[0134] Figure 38 Schematic diagram of the position of the snap fastener in the present invention;
[0135] Figure 39 Schematic diagram of the position of the blood pressure sealing piece in the present invention;
[0136] Figure 40 Schematic diagram of the position of the stop boss in the present invention;
[0137] Figure 41 Schematic diagram of the position of the guide wire hole in the present invention;
[0138] Figure 42 Top view of the bending adjustment tube in the present invention;
[0139] Figure 43 It is the sectional view at the B-B position of the bending pipe in the present invention;
[0140] Figure 44 It is the sectional view at the C-C position of the bending pipe in the present invention;
[0141] Figure 45 It is the schematic structural diagram of the support platform in the present invention;
[0142] Figure 46 It is the three-dimensional structure diagram of the support platform when in use in the present invention.
[0143] Figures 1 - 2 Explanation of reference numerals in the drawings: 01, forming ring body; 02, shaping guide wire; 2, head-end metal strip; 3, fixed-end metal strip; 4, head-end metal tube; 5, fixed-end metal tube; 6, connecting part metal tube; 7, elastic shrinkage member; 8, pull-out wire of stop pin; 9, stop pin; 10, buckle assembly; 11, buckle fixed end; 12, buckle traction wire.
[0144] Figures 3 - 46Explanation of reference numerals: a1, primary handle; a101, multi-lumen tube fixing seat; a102, push button travel groove; a103, push member; a104, push rod push button; a105, push tube; a106, angle mark; a107, multi-lumen tube; a108, round cavity; a109, branch cavity; a2, secondary handle; a201, rotation groove; a202, rotation boss; a203, inner tube support seat; a204, connecting block; a205, accommodating groove; a206, anti-rotation boss; a207, connecting Connecting groove; a208, eccentric hole; a209, multi-lumen tube blood sealing plate; a210, multi-lumen tube blood sealing gasket; a212, rivet fixing seat; a213, rivet guide tube; a214, positioning pin; a3, three-level handle; a301, outer sheath tube; a302, main cavity; a303, auxiliary cavity; a304, limit block; a305, travel groove; a306, outer sheath fixing seat; a307, front section blood sealing plate; b01, wire pulling mechanism; b02, wire pulling mechanism; b1, wire pulling sleeve; b11, first Center hole; b12, first circumferential through hole; b13, first wiring channel; b14, wire travel groove; b2, wire guide block; b21, wire outlet hole; b22, first center hole; b23, wire connecting plate; b3, first rebound screw; b4, first screw travel nut; b41, first guide extension block; b5, first compression spring; b6, first rebound cap; b7, wire turntable; b71, wire groove; b72, wire fixing hole; b8, first locking wire block; b9, wire pulling sleeve; b b91, second center through hole; b92, second circumferential through hole; b93, second wiring channel; b10, wire pulling locking sleeve; b101, locking button; b102, traction line travel groove; b110, tail wire splitter; b111, traction line outlet hole; b120, second rebound screw; b130, second screw travel nut; b131, traction line guide block; b140, second rebound cap; b150, traction line turntable; b151, traction line groove; b152, traction line fixing hole; b160 , second thread lock pull block; b170, second compression spring; c00, thread cutting mechanism; c02, reinforcement tube; c021, thread hole; c022, thread groove; c023, guide cone; c024, center hole of reinforcement tube; c025, fixing element; c03, blade fixing plate; c031, linear guide groove; c04, blade rotating plate; c041, arc guide groove; c05, cutting blade; c051, blade guide rod c052, blade edge; c06, cut-off button; d00, rivet implantation device; d100, medical rivet; d110, puncture tip; d120, rivet barb; d130, rivet avoidance groove; d140, release buckle; d141, release slot; d142, release protrusion; d143, release slope; d150, reverse spring block; d160, rivet pressing piece; d161, spike; d162, pressing piece boss;d200, Rivet integral handle; d210, Tube outlet end; d211, Bending adjustment fixing seat; d212, Wire bending control groove; d213, Positioning boss; d214, Positioning groove; d220, Pushing end; d221, Pushing cavity; d230, First bending adjustment end; d250, Bending adjustment cavity; d251, Bending adjustment sliding guide rail; d252, Wire bending control locking nut; d253, Wire bending control knob cap; d254, Wire bending control wire; d256, Wire guide hole; d257, Wire bending control wire avoiding groove; d260, Blood sealing pressure piece; d261, Blood sealing pressure piece fixing hole; d270, Blood sealing gasket; d300, Rivet pushing handle; d310, Rivet connecting pipe connecting cavity; d311, Rivet connecting pipe fixing block; d320, Coated pipe connecting cavity; d321, Coated pipe connecting slider; d322, Release button; d323, Spring fixing block; d324, Release spring; d325, Rebound spring; d330, Stopping boss; d340, Elastic buckle; d341, Elastic buckle inclined surface; d400, Rivet connecting pipe; d500, Coated pipe; d510, Opening groove; d600, Bending adjustment pipe; d610, Outer layer; d620, Intermediate layer; d630, Inner layer; d640, First traction ring; d650, Second traction ring; e00, Support platform; e1, Bottom plate; e2, Rack slide rail; e3, Teeth; e4, First support; e5, Second support; e6, Third support; e7, First sleeve; e8, Second sleeve; e9, Third sleeve; e10, Slide block; e11, Gear; e12, U-shaped groove; e13, Slide rail locking screw; e14, Quick lock bolt; e15, Rear angle mark; e16, Front angle mark.; Detailed implementation mode
[0145] The technical solutions of the present invention will be clearly and completely described below in conjunction with the accompanying drawings. Obviously, the described embodiments are part of the embodiments of the present invention, rather than all of them. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts shall fall within the protection scope of the present invention.
[0146] In the description of the present invention, it should be noted that the orientation or positional relationship indicated by the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc. is based on the orientation or positional relationship shown in the accompanying drawings. "Distal end" and "proximal end" refer to the end far from or close to the operator. It is only for the convenience of describing the present invention and simplifying the description, 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 therefore should not be construed as a limitation of the present invention. In addition, the terms "first", "second", and "third" are only used for descriptive purposes and cannot be construed as indicating or implying relative importance.
[0147] In the description of the present invention, it should be noted that unless otherwise clearly specified and defined, the terms "installation", "connection", and "coupling" should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be directly connected or indirectly connected through an intermediate medium, and it can be the communication inside two components. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific situations.
[0148] In addition, the technical features involved in different embodiments of the present invention described below can be combined with each other as long as they do not conflict with each other.
[0149] For the sake of easy understanding, a valve repair device for implementing the delivery system in the present invention is provided below. It should be noted that this valve repair device is only for facilitating the description of the present invention, rather than indicating or implying that the present invention can only be used to implement this valve repair device.
[0150] As Figure 1 、 2 shown, a valve repair device includes a forming ring body 01. The forming ring body 01 includes at least a head-end metal strip 2, a fixed-end metal strip 3, head-end metal tubes 4 and fixed-end metal tubes 5 respectively sleeved on the ends of the two metal strips, a commissural metal tube 6 sleeved between adjacent two metal strips, and an elastic shrinkage member 7; wherein, there is a shrinkage interval between the commissural metal tube 6 and the two metal tubes;
[0151] The head-end metal strip 2, the fixed-end metal strip 3, the head-end metal tube 4, the fixed-end metal tube 5 and the commissural metal tube 6 are all wound with a shaping guide wire 02. By tightening the shaping guide wire 02, the forming ring body 01 obtains auxiliary shaping and fits the surface of the autologous valve leaf of the human body, so as to facilitate the operation of implanting rivets by the delivery device;
[0152] The traction wire includes a stop pin pull-out wire 8 and a buckle traction wire 12. Specifically:
[0153] A stop pin 9 is penetrated through the commissural metal tube 6, and a stop pin pull-out wire 8 is penetrated through the stop pin 9. By pulling out the stop pin 9 through the stop pin pull-out wire 8, the size of the forming ring body 01 continuously becomes smaller under the action of the elastic shrinkage member 7, and the covering substrate extension part on the forming ring body 01 also pulls the autologous valve leaf to shrink together through the rivet, thereby realizing the repair and shaping of the autologous valve leaf.
[0154] Two metal tubes are connected by a buckle assembly 10. The buckle assembly 10 includes a buckle head end and a buckle fixed end 11 respectively connected to the head-end metal tube 4 and the fixed-end metal tube 5. The buckle head end is located inside the buckle fixed end 11. A buckle traction wire 12 is inserted between the buckle head end and the buckle fixed end 11, and both ends of the buckle traction wire 12 extend out of the fixed-end metal tube 5. By pulling the buckle traction wire 12, the buckle head end is inserted into the buckle fixed end 11 and automatically locked under the action of the specific structures of the buckle head end and the buckle fixed end 11, forming a complete ring.
[0155] As Figures 3 - 12 shown, a delivery system for a valve repair device includes: a pushing assembly, a multi-lumen tube a107, a pushing tube a105, an outer sheath tube a301, a tangent mechanism c00, a wire pulling mechanism b01, a pushing mechanism, and a wire pulling-out mechanism b02. The pushing assembly includes a primary handle a1, a secondary handle a2, and a tertiary handle a3 sequentially arranged from the proximal end to the distal end; the secondary handle a2 can rotate relative to the primary handle a1, and the tertiary handle a3 can slide back and forth relative to the secondary handle a2; inside the primary handle a1, a multi-lumen tube fixing seat a101, a tangent mechanism c00, a wire pulling mechanism b01, a pushing mechanism, and a wire pulling-out mechanism b02 are sequentially arranged from the distal end to the proximal end. The multi-lumen tube a107 is connected to the distal end of the multi-lumen tube fixing seat a101, and multiple shaping guiding wires connected to the valve repair device are connected to the wire pulling mechanism b01 and pass through the inner cavity of the multi-lumen tube a107. A push button travel groove a102 is formed on the outer wall of the primary handle a1; the pushing mechanism includes a pushing member a103 arranged inside the primary handle a1 and a push rod push button a104 connected to the pushing member a103 and slidably connected to the push button travel groove a102; the distal end of the pushing member a103 is fixed with a pushing tube a105 for delivering the valve repair device, and the pushing tube a105 passes through the multi-lumen tube fixing seat a101 and extends towards the distal end. The tangent mechanism c00 is used to cut the shaping guiding wire at the distal end of the wire pulling mechanism b01. The wire pulling-out mechanism b02 is connected with multiple traction wires passing through the pushing tube a105, and a retaining pin inserted on the valve repair device is connected to the traction wires. The outer sheath tube a301 is located on the outer periphery of the multi-lumen tube a107 and is fixed to the distal end of the tertiary handle a3.
[0156] The delivery system of this valve repair device is provided with a primary handle a1, a secondary handle a2, and a tertiary handle a3. The tertiary handle a3 can slide back and forth relative to the secondary handle a2, and the secondary handle a2 can rotate relative to the primary handle a1. By sliding the secondary handle a2 back and forth and rotating the secondary handle a2, the distance between the valve repair device and the mitral valve can be adjusted, and the valve repair device can be adjusted when implanting the annuloplasty ring. A pushing mechanism is provided. At the distal end of the pusher a103, a push tube a105 for delivering the valve repair device is fixed. By pushing the pusher button a104, the push tube a105 can be driven to move distally or proximally, and thus the valve repair device can be brought closer to or farther away from the mitral valve. The push tube a105 passes through the multi-lumen tube fixing seat a101 and extends distally and into the multi-lumen tube a107. An outer sheath tube a301 fixed to the distal end of the tertiary handle a3 is provided on the outer periphery of the multi-lumen tube a107. With such a design, the multi-lumen tube a107 and the push tube a105 can be pushed separately, and the outer sheath tube a301 can be rotated to further adjust the matching degree between the annuloplasty ring and the mitral valve.
[0157] In this embodiment, a rotation groove a201 is provided on the inner wall at the distal end of the primary handle a1, and a rotation boss a202 corresponding to the rotation groove a201 is provided on the outer wall at the proximal end of the secondary handle a2. The rotation boss a202 can rotate on the rotation groove a201. A limiting block a304 is provided on the inner wall at the distal end of the secondary handle a2, and a travel groove a305 corresponding to and cooperating with the limiting block a304 is provided on the inner wall at the proximal end of the tertiary handle a3. The limiting block a304 can slide on the travel groove a305. By providing the rotation groove a201 on the inner wall at the distal end of the primary handle a1 and the rotation boss a202 corresponding to the rotation groove a201 on the outer wall at the proximal end of the secondary handle a2, the rotation boss a202 can rotate on the rotation groove a201. By providing the limiting block a304 on the inner wall at the distal end of the secondary handle a2 and the travel groove a305 corresponding to and cooperating with the limiting block a304 on the inner wall at the proximal end of the tertiary handle a3, the limiting block a304 can slide on the travel groove a305. At the same time, through the limiting structure of the travel groove a305 and the limiting block a304, when the secondary handle a2 rotates, the tertiary handle a3 will rotate together with the secondary handle a2, which can ensure the consistency of the movement of the tertiary handle a3 and the secondary handle a2 during adjustment and ensure the stability of the adjustment.
[0158] In this embodiment, a main cavity a302 and a secondary cavity a303 are provided inside the outer sheath tube a301. The multi-lumen tube a107 is located inside the main cavity a302. A circular cavity a108 is provided at the center of the multi-lumen tube a107, and a number of branch cavities a109 are provided in the circumferential direction of the circular cavity a108. The push tube a105 is single-lumen and is located inside the circular cavity a108. Each branch cavity a109 allows a shaped guiding wire to pass through. The design of the main cavity a302 and the secondary cavity a303 can limit the distal ends of the push tube a105 and the multi-lumen tube a107, and at the same time can ensure that the different wire paths passing through the push tube a105 and the multi-lumen tube a107 are consistent, thereby ensuring the consistency and stability of the adjustment of different wires. The design of a number of branch cavities a109 in the circumferential direction of the circular cavity a108 can separately arrange multiple shaped guiding wires one by one, avoiding entanglement of multiple groups of shaped guiding wires.
[0159] Specifically, an outer sheath fixing seat a306 is provided at the distal end of the tertiary handle a3. The outer sheath tube a301 is fixedly installed on the outer sheath fixing seat a306. The proximal end face of the outer sheath fixing seat a306 is connected with a front-segment blood pressure pressing piece a307. An inner tube support seat a203 for supporting the multi-lumen tube a107 is provided at the proximal end of the secondary handle a2. The multi-lumen tube a107 and the push tube a105 pass through the inner tube support seat a203 and extend proximally.
[0160] In this embodiment, a connection block a204 is installed at the proximal end of the secondary handle a2. An anti-rotation boss a206 and an eccentric hole a208 are provided on the connection block a204. A receiving groove a205 for receiving the connection block a204 is provided on the inner wall at the proximal end of the secondary handle a2. A connection groove a207 corresponding to and cooperating with the anti-rotation boss a206 is provided at the edge of the receiving groove a205. Specifically, the eccentric hole a208 on the connection block a204 is coaxially arranged with the secondary handle a&. The multi-lumen tube a107 is located inside the eccentric hole a208. The proximal end face of the multi-lumen tube fixing seat a101 is connected with a multi-lumen tube blood pressure pressing piece d260. A multi-lumen tube blood pressure gasket d270 is also provided between the multi-lumen tube fixing seat a101 and the multi-lumen tube blood pressure pressing piece d260. With such a design, it can be ensured that when the outer sheath tube a301 rotates, the multi-lumen tube a107 and the push tube a105 inside the multi-lumen tube a107 will not rotate, and thus when delivering the medical rivet d100, the valve repair device can be prevented from being displaced.
[0161] In this embodiment, an angle mark is provided on the outer wall at the distal end of the primary handle a1, and an indicating arrow for indicating the angle mark is provided on the outer wall at the proximal end of the secondary handle a2. Since the mitral valve of the human body is not circular but D-shaped, and there are differences in the physiological structures of each person, during the transapical surgery, it is necessary to rotate the secondary handle a2 to adjust the direction, and the angle mark can facilitate the observation of the rotation angle during the surgery.
[0162] In this embodiment, a pin hole is provided at the connection between the secondary handle a2 and the tertiary handle a3, and a positioning pin a214 for locking the secondary handle a2 and the tertiary handle a3 is provided on the pin hole. In the initial state, the positioning pin a214 is inserted into the pin hole; before pushing the secondary handle a2, the positioning pin a214 is pulled out, and then the secondary handle a2 can be pushed, which is convenient to operate.
[0163] In this embodiment, as Figures 13 - 24 shown, the wire pulling mechanism b01 is located in the distal inner cavity of the primary handle a1 and includes a wire pulling sleeve b1 and a wire pulling guide block b2. Among them, the wire pulling sleeve b1 is installed in the inner cavity of the primary handle a1 and includes a first central through hole b11 that is located at the center and runs through, and a plurality of first circumferential through holes b12 that are circumferentially distributed around the first central through hole b11. A first wire routing channel b13 for guiding the shaped guiding wire into the first central through hole b11 is provided between the first central through hole b11 and any one of the first circumferential through holes b12. The wire pulling guide block b2 is arranged in the first central through hole b11 and is located at the distal end of the wire pulling sleeve b1. A plurality of wire pulling outlet holes b21 for the shaped guiding wire to pass through are provided thereon, and the positions of the plurality of wire pulling outlet holes b21 and the plurality of first circumferential through holes b12 are arranged in one-to-one correspondence.
[0164] The design of the wire pulling mechanism b01 is such that by installing the wire pulling sleeve b1 in the primary handle a1, a through first central through hole b11 is provided at the center in the wire pulling sleeve b1 and a plurality of first circumferential through holes b12 are circumferentially distributed around the first central through hole b11. A first wire routing channel b13 for guiding the shaped guiding wire into the first central through hole b11 is provided between the first central through hole b11 and any one of the first circumferential through holes b12. The wire pulling guide block b2 is arranged in the first central through hole b11, and a plurality of wire pulling outlet holes b21 for the shaped guiding wire to pass through and whose positions are arranged in one-to-one correspondence with the plurality of first circumferential through holes b12 are provided on the wire pulling guide block b2. With such a design, multiple groups of shaped guiding wires can be separated and selected for installation one by one, avoiding entanglement of multiple groups of shaped guiding wires.
[0165] In this embodiment, six first circumferential through holes b12 are provided, six wire pulling outlet holes b21 are correspondingly provided, and six groups of shaped guiding wires are provided. Specifically, through wire pulling travel grooves b14 are provided on the side walls of the six first circumferential through holes b12, and the wire pulling travel grooves b14 are arranged along the radial direction of the first central through hole b11. In the cross-section perpendicular to the axial direction of the wire pulling sleeve b1, the connection line between the center of the first central through hole b11 and the center of the first circumferential through hole b12 passes through the center of the wire pulling outlet hole b21.
[0166] In this embodiment, a first resilient screw b3 is coaxially arranged in the first circumferential through hole b12. One end of the first resilient screw b3 close to the wire guiding block b2 is connected with a wire winding disc b7 for winding the shaping guiding wire. The wire winding disc b7 is provided with a wire groove b71 for accommodating the shaping guiding wire, and a through wire fixing hole b72 is formed at the bottom of the wire groove b71. The shaping guiding wire wound on the wire winding disc b7 enters the wire outlet hole b21 of the wire guiding block b2 through the first wire channel b13.
[0167] In this embodiment, the other end of the first resilient screw b3 is provided with a first resilient cap b6 located at the proximal end of the wire sleeve b1. The outer periphery of the first resilient screw b3 is further sleeved with a first screw travel nut b4 installed on the wire travel groove b14. A first compression spring b5 is further sleeved on the first resilient screw b3 and located between the first screw travel nut b4 and the first resilient cap b6. Specifically, the first screw travel nut b4 is provided with a first guiding extension block b41 protruding outward and slidably engaged with the wire travel groove b14. Designed in this way, the first screw travel nut b4 can move back and forth relative to the wire travel groove b14 without rotation.
[0168] In this embodiment, the elastic force of the first compression spring b5 drives the first screw travel nut b4 to move towards the distal end of the first resilient screw b3 to drive the first resilient screw b3 to rotate in the first circumferential through hole b12, and the wire winding disc b7 rotates with the rotation of the first resilient screw b3 to keep the shaping guiding wire wound thereon in a tensioned state. Designed in this way, when the first screw travel nut b4 is subjected to a thrust, it drives the first resilient screw b3 to rotate through thread fit. The wire winding disc b7 rotates with the rotation of the first resilient screw b3. The first resilient screw b3 is always subjected to a rotational force through the thread fit of the first screw travel nut b4, so that the wire winding disc b7 always tightens the shaping guiding wire, and the shaping guiding wire always maintains a tension force, avoiding entanglement of the six groups of shaping guiding wires in a loose state. In addition, by adjusting the parameters of the wire drawing device (such as the thread pitch between the first screw travel nut b4 and the first resilient screw b3, the diameter ratio between the first resilient screw b3 and the wire winding disc b7, and the elastic force characteristic curve of the first resilient spring d325), the magnitude of the tension force received by the shaping guiding wire can be changed.
[0169] In this embodiment, a first central hole b22 for the push tube a105 to pass through is further formed in the middle of the wire guiding block b2, and six wire outlet holes b21 are circumferentially and uniformly arranged on the outer periphery of the first central hole b22. The distal end of the wire guiding block b2 is integrally connected with a wire connecting plate b23, and the wire connecting plate b23 is fixed on the outer wall of the distal end of the wire sleeve b1.
[0170] In this embodiment, six shaping guide wire outlet holes are further formed on the outer wall of the primary handle a1. A first wire-locking pull block b8 is provided on the shaping guide wire outlet hole. One end of the shaping guide wire is connected to the first wire-locking pull block b8, and the other end is connected to the wire-pulling turntable b7.
[0171] In this embodiment, the wire-pulling mechanism b02 is arranged in the proximal inner cavity of the primary handle a1 and is located at the proximal end of the wire-pulling sleeve b1. Specifically, the wire-pulling mechanism b02 includes a wire-pulling sleeve b9, a tail-end wire-splitting member b110, and a wire-pulling locking sleeve b10.
[0172] The wire-pulling sleeve b9 is installed in the proximal inner cavity of the primary handle a1 and includes a second central through-hole b91 that is located at the center and runs through, and three second circumferential through-holes b92 that are circumferentially distributed around the second central through-hole b91.
[0173] The tail-end wire-splitting member b110 is installed on the second central through-hole b91, and one end passes through the second central through-hole b91 from the proximal end of the wire-pulling sleeve b9. Three traction wire outlet holes b111 for the traction wire to pass through are provided thereon. The wire-pulling locking sleeve b10 is installed on the second circumferential through-hole b92, and one end passes through the second circumferential through-hole b92 from the proximal end of the wire-pulling sleeve b9. A second wire-walking channel b93 for the traction wire inside it to extend outward is provided on the outer wall of the wire-pulling locking sleeve b10. The positions of the three second wire-walking channels b93 and the three traction wire outlet holes b111 are arranged in one-to-one correspondence.
[0174] Specifically, a through traction wire travel groove b102 is formed on the side wall of the wire-pulling locking sleeve b10, and the traction wire travel groove b102 is arranged radially along the second central through-hole b91.
[0175] In this embodiment, a second return screw b120 is coaxially arranged in the inner cavity of the wire-pulling locking sleeve b10. A traction wire turntable b150 for the traction wire to wind around is connected to one end of the second return screw b120 close to the wire-pulling sleeve b9, and a second return cap b140 located at the distal end of the wire-pulling locking sleeve b10 is provided at the other end. Specifically, a traction wire groove b151 for accommodating the traction wire is provided on the traction wire turntable b150, and a through traction wire fixing hole b152 is formed at the bottom of the traction wire groove b151.
[0176] In this embodiment, a second central hole for the pushing tube a105 to pass through is further formed in the middle of the tail-end wire-splitting member b110. The three traction wire outlet holes b111 are circumferentially and evenly arranged on the outer periphery of the second central hole. Specifically, the tail-end wire-splitting member b110 is fixed on the outer wall surface at the distal end of the wire-pulling sleeve b9, and the traction wire outlet holes b111 are inclined outward from the distal end to the proximal end of the tail-end wire-splitting member b110. Designed in this way, the problem that the traction wire has a large resistance and is easily stuck when exiting at 90° can be avoided.
[0177] In this embodiment, a second screw travel nut b130 is sleeved on the outer periphery of the second resilient screw b120 and is slidably mounted on the traction wire travel groove b102. A traction wire guide block b131 that protrudes outward and is slidably engaged with the traction wire travel groove b102 is provided on the second screw travel nut b130. With such a design, the second screw travel nut b130 can move back and forth relative to the traction wire travel groove b102 without rotation.
[0178] In this embodiment, a second compression spring b170 is also sleeved on the second resilient screw b120 and is located between the second screw travel nut b130 and the second resilient cap b140. Specifically, the elastic force of the second compression spring b170 drives the second screw travel nut b130 to move towards the distal end of the second resilient screw b120, so as to drive the rotation of the second resilient screw b120 to keep the traction wire wound thereon in a tensioned state.
[0179] In this embodiment, the wire-pulling locking sleeve b10 is slidably mounted along the axial direction of the second circumferential through-hole b92 in the second circumferential through-hole b92, and a locking button b101 for locking the wire-pulling locking sleeve b10 on the second circumferential through-hole b92 is provided on the wire-pulling sleeve b9. With such a design, the wire-pulling locking sleeve b10 can be fixedly connected to the wire-pulling sleeve b9 through the locking button b101.
[0180] In this embodiment, three traction wire outlet holes b111 are provided on the outer wall of the primary handle a1, and a second wire-locking pull block b160 is provided on the traction wire outlet holes b111. One end of the traction wire is connected to the second wire-locking pull block b160 and the other end is connected to the traction wire turntable b150. With such a design, after the use of the traction wire, the unnecessary traction wire can be directly pulled out by pulling the second wire-locking pull block b160, and the operation is convenient.
[0181] In an alternative embodiment, the first circumferential through-hole b12 can be provided with four or eight or ten, the wire outlet holes b21 are correspondingly provided with four or eight or ten, the number of the shaping guide wires and the shaping guide wire outlet holes is the same as the number of the first circumferential through-holes b12, and the number of the second circumferential through-holes b92, the shaping guide wire outlet holes, the traction wires, and the traction wire outlet holes b111 are all half of the number of the first circumferential through-holes b12.
[0182] In an alternative embodiment, either the wire pulling guide block b2 and the end wire splitting member b110 in the wire pulling mechanism b01 or those in the wire extracting mechanism b02 can be arbitrarily used; either the wire pulling sleeve b1 or the wire extracting sleeve b9 can also be used; the only difference is that the combination of the locking lock button b101 and the wire extracting locking sleeve b10 can achieve the wire extracting effect. To adapt to the effects of the wire pulling mechanism b01 and the wire extracting mechanism b02, the first rebound cap b6 of the wire pulling mechanism b01 can be provided with an internal hexagonal head, and the second rebound cap b140 of the wire extracting mechanism b02 can be provided with a flat head.
[0183] In this embodiment, the difference between the wire extracting mechanism b02 and the wire pulling mechanism b01 is as follows: during the use of the wire pulling mechanism b01, the wire pulling tension is provided by the wire pulling mechanism b01. After the implantation of the implanting device is completed, it is directly cut off. Part of it is recovered by the wire pulling mechanism b01, and the other part is extracted by the first wire locking pull block b8; during the use of the wire extracting mechanism b02, the locking element (stop pin) of part of the implanting device needs to be extracted together with the wire.
[0184] Therefore, the wire extracting mechanism b02 needs to first pull out the locking button b101 inserted on the wire extracting locking sleeve b10, then clamp the handle of the second rebound cap b140, and directly pull out the wire extracting locking sleeve b10 from the wire extracting sleeve b9. The wire extracting mechanism b02 can also produce the same effect as the wire pulling mechanism b01 (i.e., cutting the wire), that is, manually cutting the traction wire at the second wire locking pull block b160 and pulling out the wire extracting locking sleeve b10.
[0185] In this embodiment, as Figures 25 - 29As shown, the tangent mechanism c00 is installed at the distal end of the first-level handle a1, and includes a reinforcing tube c02, a blade fixing disk c03, a blade rotating disk c04, and multiple cutting blades c05. Specifically, multiple wire passing holes c021 extending along the axial direction of the reinforcing tube c02 are provided inside the reinforcing tube c02, and the multiple wire passing holes c021 are arranged along the circumferential direction of the reinforcing tube c02; a wire exposing groove c022 communicating with the multiple wire passing holes c021 is provided on the outer peripheral wall of the reinforcing tube c02. The blade fixing disk c03 is fixed on the first-level handle a1 and sleeved on the outer periphery of the reinforcing tube c02, and multiple linear guiding grooves c031 are formed on one side edge of the blade fixing disk c03. The blade rotating disk c04 is rotatably sleeved on the outer periphery of the reinforcing tube c02 along the axial direction of the reinforcing tube c02 and is arranged opposite to the blade fixing disk c03; multiple arc-shaped guiding grooves c041 are formed on the side wall of the blade rotating disk c04 facing the blade fixing disk c03; the multiple arc-shaped guiding grooves c041 and the multiple linear guiding grooves c031 are arranged in one-to-one correspondence. The multiple cutting blades c05 are located between the blade fixing disk c03 and the blade rotating disk c04 and are on the same plane as the wire exposing groove c022, and a blade guiding rod c051 is connected thereto; one end of the blade guiding rod c051 extends into the linear guiding groove c031, and the other end extends into the corresponding arc-shaped guiding groove c041. During the rotation of the blade rotating disk c04, the blade guiding rods c051 of the multiple cutting blades c05 are simultaneously slid in the linear guiding groove c031 and the arc-shaped guiding groove c041, so that the cutting blades c05 approach or move away from the wire exposing groove c022 on the reinforcing tube c02.
[0186] Design of the tangent mechanism c00: By providing a reinforcing tube c02 with multiple wire passing holes c021 axially distributed, a wire exposing groove c022 communicating with the multiple wire passing holes c021 is provided on the outer peripheral wall of the reinforcing tube c02 to facilitate the exposure of the shaping guide wire in the reinforcing tube c02; a blade fixing disk c03 and a blade rotating disk c04 are provided on the outer periphery of the reinforcing tube c02. A plurality of linear guide grooves c031 are formed on one side edge of the blade fixing disk c03. A plurality of arc-shaped guide grooves c041 are formed on the side wall of the blade rotating disk c04 facing the blade fixing disk c03. The plurality of arc-shaped guide grooves c041 and the plurality of linear guide grooves c031 are arranged in one-to-one correspondence. A plurality of cutting blades c05 are provided between the blade fixing disk c03 and the blade rotating disk c04. The cutting blades c05 and the wire exposing groove c022 are located in the same plane. A blade guide rod c051 is connected to the cutting blade c05. One end of the blade guide rod c051 extends into the linear guide groove c031 and the other end extends into the corresponding arc-shaped guide groove c041. During the relative rotation of the blade rotating disk c04 and the blade fixing disk c03 along the axis direction of the reinforcing tube c02, the plurality of cutting blades c05 approach or move away from the wire exposing groove c022 following the movement of the blade rotating disk c04. When the cutting blade c05 rotates to the wire exposing groove c022, a plurality of shaping guide wires located at the wire exposing groove c022 in the wire passing hole c021 can be cut simultaneously; compared with the prior art in which the multiple shaping guide wires connected to the implanting device are cut one by one, it avoids the situation that the implanting device is partially stressed and partially unstressed during the wire cutting process, thereby preventing problems such as tilting, displacement, and bending of the implanting device.
[0187] In this embodiment, six linear guide grooves c031 are circumferentially and evenly formed on the side of the blade fixing disk c03 close to the blade rotating disk c04. The guiding directions of the six linear guide grooves c031 are all set in the reverse radial direction of the blade fixing disk c03, and are not perpendicular to the radial direction of the blade fixing disk c03.
[0188] In this embodiment, six arc-shaped guide grooves c041 are circumferentially formed on the side of the guiding rotating disk close to the blade fixing disk c03. The six linear guide grooves c031 and the six arc-shaped guide grooves c041 are arranged in one-to-one correspondence. The distances from the two ends of the arc-shaped guide groove c041 to the center of the blade rotating disk c04 are not equal.
[0189] In this embodiment, the reinforcing tube c02 is fixedly connected to the blade turntable c04. A fixing element c025 is connected to the proximal end of the reinforcing tube c02. The fixing element c025 is sleeved on the outer periphery of the reinforcing tube c02 and is used to fix the blade fixing disc c03 in the primary handle a1. The fixing element c025 protrudes outward to form a clamping block and is clamped in the primary handle a1, thereby fixing the blade fixing disc c03 in the primary handle a1. Six wire passing holes c021 are circumferentially provided on the reinforcing tube c02. A reinforcing tube central hole c024 for the pushing tube a105 to pass through is also provided in the middle of the reinforcing tube c02. The six wire passing holes c021 are circumferentially and uniformly arranged on the outer periphery of the reinforcing tube central hole c024. An exposed wire groove c022 is provided in the middle of the reinforcing tube c02, and a guiding conical surface c023 is also provided on the exposed wire groove c022. With such a design, the blade edge c052 of the cutting blade c05 can more accurately abut against the exposed wire groove c022, and the shearing effect can be improved by the incision between the blade edge c052 and the guiding conical surface c023.
[0190] In this embodiment, six cutting blades c05 are provided and are in a spiral shape. Blade guiding rods c051 are integrally formed on both ends of the six cutting blades c05. The two ends of the blade guiding rods c051 on the six cutting blades c05 are respectively inserted into six linear guiding grooves c031 and six arc-shaped guiding grooves c041 one by one.
[0191] Specifically, one end of the cutting blade c05 close to the reinforcing tube c02 is provided with an arc-shaped blade edge c052. The arcs of the multiple blade edges c052 are concentric with the exposed wire groove c022. With such a design, all the blade edges c052 can abut against the exposed wire groove c022 without gaps, ensuring that the blade edges c052 completely cut the shaped guiding wire at the exposed wire groove c022.
[0192] Specifically, the cutting blade c05 has a first arc-shaped side on one side of the blade edge c052 and a second arc-shaped side on the other side of the blade edge c052. When the multiple cutting blades c05 extend into the exposed wire groove c022, the first arc-shaped side of the cutting blade c05 matches the second arc-shaped side of an adjacent cutting blade c05, and the first arc-shaped side of the cutting blade c05 matches the second arc-shaped side of another adjacent cutting blade c05. With such a design, the structural compactness is good, and when the multiple cutting blades c05 rotate to abut against the exposed wire groove c022, the sides can just be matched and docked, avoiding mutual interference and resulting in the inability to cut the shaped guiding wire.
[0193] In this embodiment, a cutting button travel groove is provided on the outer wall of the primary handle a1, and a cutting button c06 extending outside the cutting button travel groove is connected to the outside of the blade turntable c04.
[0194] In this embodiment, asFigure 3 、 Figures 30 - 44 As shown, the secondary handle a2 is provided with a rivet implantation branch end, and the proximal end of the rivet implantation branch end is provided with a rivet fixing seat a212; the interior of the secondary handle a2 is provided with a rivet guide tube a213, one end of the rivet guide tube a213 passes through the inner tube support seat a203 and is connected to the outer sheath fixing seat a306 and communicates with the sub-cavity a303; the other end of the rivet guide tube a213 is connected to the rivet fixing seat a212.
[0195] In this embodiment, the rivet implantation device d00 is connected to the proximal end of the rivet guide tube a213, and includes a rivet integral handle d200, a rivet pushing handle d300, a medical rivet d100, and a rivet connecting tube d400 connected to the release buckle d140 of the medical rivet d100; the rivet connecting tube d400 extends into the rivet guide tube a213; the medical rivet d100 has a shape memory function. Specifically, the medical rivet d100 includes a puncture tip d110, a rivet barb d120, a rivet avoidance groove d130, a release buckle d140 and a reverse spring block d150, wherein the puncture tip d110 is located at the distal end of the medical rivet d100; the rivet barb d120 is located at one end of the side wall of the medical rivet d100 close to the puncture tip d110; the rivet avoidance groove d130 is located on the outer wall of the medical rivet d100 and is arranged corresponding to the position of the rivet barb d120; the release buckle d140 is located at the proximal end of the medical rivet d100, and is used to be connected to the rivet connecting tube d400; the reverse spring block d150 is arranged at one end of the medical rivet d100 close to the release buckle d140. The rivet barb d120 has an initial state in which it is expanded outward in a natural state and the barb thereon is arranged toward the proximal end, and a loaded state in which the rivet barb d120 is retracted into the rivet avoidance groove d130 under the action of an external force; the reverse spring block d150 has an initial state in which it is bent outward in a natural state and expanded and its end away from the medical rivet d100 is arranged toward the distal end, and a loaded state in which the reverse spring block d150 is bent in the reverse direction toward the proximal end under the action of an external force.
[0196] The design of the medical rivet d100 provides an anchoring effect on the distal end face of the surgical site by setting rivet barbs d120 on the side wall of the medical rivet d100 near the puncture tip d110. The rivet avoidance groove d130 is provided to accommodate the rivet barbs d120 during loading, thereby reducing the conveying diameter of the conveying system. The reverse elastic block d150 is arranged at one end of the medical rivet d100 near the release buckle d140. In the natural state, the reverse elastic block d150 expands outwards, and the barbs thereon face the distal end. Under the action of the shape memory function, after the medical rivet d100 is implanted, the reverse elastic block d150 naturally expands outwards to provide an anchoring effect on the proximal end face of the surgical site, thereby cooperating with the rivet barbs d120 to achieve double-sided anchoring of the surgical site, so as to enhance the riveting strength of the medical rivet d100, improve the error tolerance rate, and reduce the probability of mistakes. In addition, compared with the medical rivet d100 in the prior art, this medical rivet d100 has a shorter overall length under the same anchoring effect, and during the mitral valve opening and closing movement, it avoids the problems of piercing the myocardium due to the excessive length of the medical rivet d100, resulting in myocardial injury and inflammatory reactions.
[0197] In this embodiment, the reverse elastic block d150 is integrally formed on both sides of the medical rivet d100. In an alternative embodiment, the reverse elastic block d150 is two elastic pieces respectively outside the medical rivet d100. In an alternative embodiment, the reverse elastic block d150 is an arched elastic piece penetrating through the middle of the medical rivet d100 and welded and fixed on the medical rivet d100.
[0198] In this embodiment, a rivet pressing piece d160 is also coaxially sleeved outside the medical rivet d100. The rivet pressing piece d160 is cylindrical, and several outwardly protruding spikes d161 are provided at the distal end of the rivet pressing piece d160. With such a design, the spikes d161 can firmly fix the periphery of the surgical site punctured by the medical rivet d100, and avoid the problem of enlarged tearing at the puncture site when the medical rivet d100 is pulled.
[0199] In this embodiment, the gap between the rivet pressing piece d160 and the medical rivet d100 can allow the coating tube d500 to pass through. An opening groove d510 is provided at the distal end of the coating tube d500, and a pressing piece boss d162 for limiting cooperation with the opening groove d510 is provided on the inner side wall of the rivet pressing piece d160. With such a design, the distal end can be slightly opened through the opening groove d510 to facilitate loading the rivet into the implant device; at the same time, the opening groove d510 and the pressing piece boss d162 of the rivet pressing piece d160 can form a stop mechanism, so as to ensure that the rivet pressing piece d160 moves together during the pushing process of the coating tube d500, and ensure that the rivet pressing piece d160 can stay at the implant site and will not be taken out together during the release process.
[0200] In this embodiment, the implant device includes a rivet integral handle d200, a rivet pushing handle d300, a medical rivet d100, and a rivet connecting tube d400 connected to a release buckle d140 of the medical rivet d100. Specifically, a release slot d141 and a release protrusion d142 located at the proximal end of the release buckle d140 are provided on the release buckle d140. A release inclined surface d143 located between the release protrusion d142 and the release slot d141 is provided at the proximal end of the release slot d141; a fastening structure adapted to the release slot d141 and the release inclined surface d143 is provided at the distal end of the rivet connecting tube d400, and the rivet connecting tube d400 is tightly connected to the release buckle d140 through the release protrusion d142 and the release slot d141.
[0201] In this embodiment, the rivet integral handle d200 includes a tube outlet end d210 located at the distal end and a pushing end d220 located at the proximal end. A pushing cavity d221 is provided inside the pushing end d220. The front section of the rivet pushing handle extends into the pushing cavity d221 and can reciprocate axially relative to the pushing cavity d221. A rivet connecting tube connecting cavity d310 is provided inside the rivet pushing handle d300, and a rivet connecting tube fixing block d311 is provided inside the rivet connecting tube connecting cavity d310. The proximal end of the rivet connecting tube d400 passes through the tube outlet end d210 and the pushing end d220 and is fixedly connected to the rivet connecting tube fixing block d311; a spring buckle d340 is provided on the cavity wall of the pushing cavity d221, a spring buckle inclined surface d341 is provided at the proximal end of the spring buckle d340, and a stop boss d330 adapted to be snap-fitted with the spring buckle d340 is provided on the outer wall of the front section of the rivet pushing handle d300. Designed in this way, through the cooperation of the spring buckle d340 and the stop boss d330, the stop boss d330 moves toward the proximal end and slides across the spring buckle inclined surface d341 of the spring buckle d340. After the stop boss d330 passes over the spring buckle d340, it is stopped by the spring buckle d340 after the spring buckle d340 automatically resets. The rivet pushing handle d300 remains in a stopped state after the medical rivet d100 is implanted, avoiding the return of the medical rivet d100 caused by manual operation.
[0202] In this embodiment, a covering tube d500 is coaxially sleeved on the outer periphery of the rivet connecting tube d400. The design of the covering tube d500 enables the medical rivet d100 to accompany the bending tube d600 to adjust the direction during the process of delivering the medical rivet d100 to the surgical site, and provides better axial compression resistance and bending performance during the pushing process.
[0203] In this embodiment, a covering tube connection cavity d320 is further provided inside the rivet pushing handle d300. The covering tube connection cavity d320 is located at the distal end of the rivet connection tube connection cavity d310. A covering tube connection slider d321 is provided inside the covering tube connection cavity d320. A return spring d325 is provided between the covering tube connection slider d321 and the distal cavity wall of the covering tube connection cavity d320. A spring fixing block d323 and a release button d322 are further provided inside the covering tube connection cavity d320. The release button d322 is elastically connected to the spring fixing block d323 through a release spring d324; the covering tube connection slider d321 can slide reciprocally relative to the covering tube connection cavity d320; the rivet connection tube d400 passes through the covering tube connection slider d321 and is fixedly connected to the rivet connection tube fixing block d311. With such a design, through the cooperation of the covering tube d500 and the release button d322, after the puncture tip d110 penetrates through the surgical site, by pressing the release button d322, the restriction of the covering tube connection slider d321 is released. Under the action of the release spring d324, the covering tube connection slider d321 slides towards the proximal end, driving the covering tube d500 to displace towards the proximal end, so that the puncture tip d110 is released from the constraint of the covering tube d500. At the same time, the release buckle d140 and the rivet connection tube d400 are released from the locked and clamped state and separate from each other. By directly pressing the release button d322 during release, the release process can be made faster and more convenient, avoiding the situation of misalignment of the medical rivet d100 caused by manual control of the stroke when releasing the medical rivet d100.
[0204] In this embodiment, a bending adjustment tube d600 is coaxially sleeved on the outer periphery of the covering tube d500. The overall rivet handle d200 further includes a first bending adjustment end d230 and a second bending adjustment end that communicate with the tube outlet end d210; bending adjustment cavities d250 are provided inside both the first bending adjustment end d230 and the second bending adjustment end. Coaxial bending adjustment sliding guide rails d251 are provided inside the bending adjustment cavities d250. A bending control knob cap d253 is provided at the proximal end of the bending adjustment cavity d250. The bending control knob cap d253 is connected to the bending adjustment sliding guide rail d251. A bending control lock wire nut d252 that is threadedly connected to the outer periphery of the bending adjustment sliding guide rail d251 and slides on the inner wall of the bending adjustment cavity d250 is provided; by rotating the bending control knob cap d253, the bending control lock wire nut d252 can be driven to reciprocate axially along the bending adjustment sliding guide rail d251; a bending control guide wire d254 is connected to the bending control lock wire nut d252, and the other end of the bending control guide wire d254 is connected to the bending adjustment tube d600. Specifically, a guide wire hole d256 is provided on the bending control lock wire nut d252, and one end of the bending control guide wire d254 is fixedly connected to the guide wire hole d256. With such a design, by rotating the first bending adjustment end d230 and the second bending adjustment end, the bending control knob cap provided inside the bending adjustment cavity d250 drives the bending control lock wire nut d252 to reciprocate axially along the bending adjustment sliding guide rail d251, and further drives the bending control guide wire d254 connected to the bending control lock wire nut d252 to perform axial reciprocating movement, so as to achieve the effect of two-way bending adjustment.
[0205] In this embodiment, the bending tube d600 includes an outer layer d610, an intermediate layer d620, and an inner layer d630 arranged in sequence from outside to inside. Specifically, the outer layer d610 of the bending tube d600 is made of a PA and PEbax mixed material, the intermediate layer d620 is made of stainless steel or nickel-titanium alloy, and the inner layer d630 is made of PDFE or PTFE. The front section of the bending tube d600 is provided with a first traction ring d640 and a second traction ring d650. The bending control wire d254 at the first bending end d230 is connected to the first traction ring d640, and the bending control wire d254 at the second bending end is connected to the second traction ring d650.
[0206] In this embodiment, a bending fixing seat d211 is fixedly arranged at one end of the tube outlet d210 close to the first bending end d230 and the second bending end. One end of the bending tube d600 is fixedly connected to the bending fixing seat d211. The bending fixing seat d211 is provided with a central hole of the bending fixing seat for the covering tube d500 to pass through and a bending control wire groove d212 for the bending control wire d254 to pass through. Specifically, one section of the bending control wire d254 is fixed in the wire guide hole d256, and the other end passes through the bending control wire groove d212 arranged in the bending fixing seat d211 and finally extends into the intermediate layer d620 of the bending tube d600.
[0207] In this embodiment, a blood sealing pressure piece d260 is connected to the proximal end of the bending fixing seat d211. The distal end of the blood sealing pressure piece d260 extends into the bending fixing seat d211. The blood sealing pressure piece d260 is provided with a blood sealing pressure piece fixing hole d261 and a bending control wire avoiding groove d257. The blood sealing pressure piece d260 is fixedly connected to the bending fixing seat d211 by a screw passing through the blood sealing pressure piece fixing hole d261. A blood sealing gasket d270 is also padded inside the bending fixing seat d211 at the distal end of the blood sealing pressure piece d260. A positioning boss d213 is arranged on the inner side wall of the bending fixing seat d211, and a positioning groove d214 corresponding to the position of the positioning boss d213 is arranged on the inner wall of the rivet integral handle d200. Designed in this way, the stability of the bending fixing seat d211 in the rivet integral handle d200 can be ensured.
[0208] Usage principle of the rivet implantation device d00: When loading the medical rivet d100, in cooperation with the opening groove d510 on the covering tube d500, the opening groove d510 can be slightly pried open, the reverse elastic block d150 and the rivet barb d120 are pressed by fingers and inserted into the opening groove d510, and finally, through the cooperation of the pressing piece boss d162 and the opening groove d510, the rivet pressing piece d160 is sleeved outside the covering tube d500 to complete the loading of the medical rivet d100.
[0209] After loading is completed, the medical rivet d100 is delivered to a location where the medical rivet d100 needs to be implanted through an implantation device.
[0210] During the delivery process, if the bending needs to be adjusted, the bending control knob cap d253 of the first bending adjustment end d230 and the second bending adjustment end can be rotated to make the bending adjustment tube d600 bend accordingly to adapt to the delivery path.
[0211] After reaching the predetermined position, push the rivet pushing handle d300 to make the medical rivet d100 move distally. At this time, the covering tube d500 and the rivet connecting tube d400 move distally synchronously. The covering tube d500 and the medical rivet d100 puncture the surgical site together through the puncture tip d110.
[0212] After the puncture tip d110 passes through the surgical site, press the release button d322, and the covering tube connecting slider d321 will immediately release the fixed restriction. The medical rivet d100 slides toward the proximal end under the action of the rebound spring d325, and at the same time drives the covering tube d500 to move toward the proximal end. After the medical rivet d100 is freed from the constraint of the covering tube d500, the rivet barb d120 on the medical rivet d100 automatically unfolds under the action of the shape memory function and hooks the distal surface of the surgical site. The reverse spring block d150 of the medical rivet d100 can automatically rebound under the action of the shape memory function and based on its reverse setting of the bending shape. While rebounding, it presses the rivet pressing sheet d160 so that the rivet pressing sheet d160 fits tightly to the proximal surface of the surgical site. Since the distal surface of the rivet pressing piece d160 is provided with a micro-nail d161 that can slightly penetrate near the circumference of the puncture site, it can avoid the occurrence of spreading tearing at the puncture site of the medical rivet d100 when the medical rivet d100 is subjected to force.
[0213] After the sheath tube d500 moves proximally past the release buckle d140, the release buckle d140 of the medical rivet d100 and the rivet connecting tube d400 release their locked state and disengage from each other. In this released state, the medical rivet d100 has been implanted and remains perfectly in the surgical site where it was implanted.
[0214] In this embodiment, if Figures 45 - 46 The device also includes a delivery system e00 for transporting a valve repair device, comprising a base plate e1, a rack rail e2 secured to the base plate e1, and a first support e4 and a second support e5 slidably mounted on the rack rail e2. The first support e4 is provided with a first sleeve e7 for mounting the primary handle a1 of the pusher device, while the second support e5 is provided with a second sleeve e8 for mounting the secondary handle a2 of the pusher device.
[0215] Design of the support table e00. By providing a bottom plate e1 with a rack slide rail e2, a first support e4 and a second support e5 are slidably arranged on the rack slide rail e2. A first sleeve e7 is provided on the first support e4, and the first sleeve e7 is used to install the primary handle a1 of the pushing device. A second sleeve e8 is provided on the second support e5, and the second sleeve e8 is used to install the secondary handle a2 of the pushing device. With such a design, when implanting the rivet, the first sleeve e7 can position the primary handle a1, and the second sleeve e8 can restrict the secondary handle a2 from rotating along the central axis of the second sleeve e8. When rotating the second sleeve e8, the first sleeve e7 will not rotate, which is beneficial to improving the success rate of the forming ring implantation surgery. The first support e4 and the second support e5 are arranged on the rack slide rail e2, enabling the pushing device to slide on a straight line formed by the first support e4 and the second support e5, which can ensure the stability of the forming ring device during the pushing process in the forming ring intervention surgery, guarantee the cooperation between the forming ring and the human mitral valve during the intervention, and thus improve the success rate of the intervention surgery.
[0216] In this embodiment, there are two rack slide rails e2. Both the first support e4 and the second support e5 have two legs. Sliders e10 are connected to the legs on the same side of the first support e4 and the second support e5 respectively. The two rack slide rails e2 are slidably mated with the corresponding sliders e10. The side of the rack slide rail e2 with a gear e11 is inclined. The first sleeve e7 and the second sleeve e8 are located on the same straight line inclined to the horizontal line, and the angle between the straight line and the horizontal line is the same as the inclination gradient of the rack slide rail e2.
[0217] In this embodiment, the bottoms of the first support e4 and the second support e5 are fixed on the same slider e10. A gear e11 meshing with the rack slide rail e2 is installed on the slider e10. Specifically, a U-shaped groove e12 is formed in the slider e10, and the gear e11 is installed between the opposite side walls of the U-shaped groove e12. The lower end of the slider e10 is slidably connected to the part of the rack slide rail e2 without teeth e3. A locking member for tightly pressing the rack slide rail e2 is also connected to the side wall of the slider e10. The locking member is specifically a slide rail locking screw e13.
[0218] In this embodiment, a rear angle mark e15 for recording the initial angle of the primary handle a1 is provided on the first sleeve e7. A front angle mark e16 for recording the rotation angle of the secondary handle a2 is provided on the second sleeve e8. The design of the rear angle mark e15 can adjust the matching degree between the forming ring and the "D"-shaped mitral valve by observing the angle indicated by the primary handle a1 and the rear angle mark e15. The design of the front angle mark e16 can observe the rotation angle of the secondary handle a2 relative to the primary handle a1 through the front angle mark e16, which is convenient for implanting the rivet when the secondary handle a2 rotates to the corresponding degree.
[0219] In this embodiment, a third support e6 is further provided on the bottom plate e1, and a third sleeve e9 for installing the three-stage handle a3 of the pushing device is provided on the third support e6; the first sleeve e7, the second sleeve e8, and the third sleeve e9 are all on the same straight line. Quick-lock bolts e14 are provided on the first sleeve e7, the second sleeve e8, and the third sleeve e9.
[0220] Usage method of the support platform e00:
[0221] In the step of implanting the forming ring, the three-stage sleeves of the first support e4, the second support e5, and the third support e6 are respectively matched with the first-stage handle a1, the second-stage handle a2, and the three-stage handle a3. The corresponding actions of the support platform e00 are:
[0222] Before implantation, the quick-lock bolts e14 of the first support e4, the second support e5, and the third support e6 need to be tightened. When implanting, the slide rail locking screw e13 is released, so that the first support e4 and the second support e5 on the rack slide rail e2 slide towards the distal end. After implantation, the slide rail locking screw e13 is screwed in again to keep the support platform e00 stationary.
[0223] Then rotate the quick-lock bolts e14 of the first support e4, the second support e5, and the third support e6 to slightly loosen the three-stage sleeves. After fine adjustment, the quick-lock bolts e14 are tightened again. By observing the angle indicated by the first-stage handle a1 and the rear angle mark e15, it is convenient to adjust the matching degree between the forming ring and the "D" shape of the human mitral valve. Keep it stationary after reaching the accurate implantation position. When removing the device that does not need to remain in place, rotate the quick-lock bolts e14 of the second support e5 and the third support e6 to loosen the second sleeve e8 and the third sleeve e9, but keep the first support e4 in the locked state, so that the second-stage handle a2 and the three-stage handle a3 can rotate relative to the first-stage handle a1 and return to the original position. The rotation angle can be judged by observing the second-stage handle a2 and the front angle mark e16. Keep it stationary after returning to the original position, and then open all the quick-lock bolts e14, and move the handle as a whole towards the proximal end to withdraw the delivery system.
[0224] Usage principle of the valve repair device:
[0225] The valve repair device includes a forming ring body with shape memory function, a snap head end located at one end of the forming ring body, and a snap fixing end located at the other end of the forming ring body. The initial state of the valve repair device before delivery is linear and is placed in the main cavity a302 of the outer sheath tube a301. The snap fixing end of the valve repair device abuts against the distal end face of the multi-lumen tube a107. Six shaping guide wires are inserted into six sub-cavities a303 of the multi-lumen tube a107, and two stop pin pull-out wires and one traction wire are inserted into the push tube a105.
[0226] When the outer sheath a301 is passed through the apex of the heart to the vicinity of the mitral valve, delivery begins:
[0227] Step 1: Push the secondary handle a2 distally relative to the primary handle a1 to push the annuloplasty repair paper out of the outer sheath a301. The annuloplasty ring body automatically forms a ring shape under the characteristics of the memory alloy and the tension of the shaping guide wire.
[0228] Step 2: Toggle push rod button a104 to move push tube a105 distally. The distal end of push tube a105 presses against the surface of the valve repair device's snap assembly. As the traction wire passes through push tube a105 and connects to the wire extraction mechanism b02, it pulls the traction wire against the snap assembly, effectively snapping the snap assembly into place. This closes the snap assembly, and the forming ring body forms a closed annular shape. (At this point, the traction wire can be cut, and the corresponding wire extraction locking sleeve in the wire extraction mechanism b02 can be removed.)
[0229] Step 3: (Fine adjustments may be required) Fine-tune the secondary handle a2 (push and rotate). The secondary handle a2 and the tertiary handle a3 are locked and rotated synchronously, so that the coating substrate on the annuloplasty ring body fits the upper surface of the native valve leaflet and the D-shape of the annuloplasty ring body matches the D-shape of the human mitral valve.
[0230] Step 4: Insert the medical rivet d100 and rivet implantation device d00 through the rivet guide tube a213. The medical rivet d100 is inserted from the lower surface of the native valve leaflet, passing through the native valve leaflet, the lower PET mesh (lower covering), the nickel-titanium alloy mesh (mesh substrate), and the upper PET mesh (upper covering). The rivet barbs d120 are then padlocked to the upper PET mesh. The rivet pressure piece d160 compresses the lower surface of the native valve leaflet. Micro-thorns d161 on the rivet pressure piece d160 prevent propagation of tearing. After implanting the medical rivet d100, the rivet implantation device d00 is withdrawn.
[0231] Step 5: Operate the secondary handle a2. At this time, the secondary handle a2 rotates relative to the primary handle a1, causing the outer sheath a301 and the rivet guide tube a213 to rotate a certain angle, and then insert the medical rivet d100 and its implantation device through the rivet guide tube a213 again. Repeat this several times.
[0232] Step 6: After completing the implantation of all medical rivets d100, turn the cutting button c06 to cut off all 6 shaping guide wires at one time through the cutting mechanism c00.
[0233] Step 7: Pull out the locking button b101 of the wire pulling sleeve b9, and then pull out the wire pulling sleeve b9, and pull out the two stop pins of the valve repair shaping device together with the two stop pins.
[0234] Step Eight: After the two stop pins are pulled out, the forming ring body automatically completes contraction under its own shape memory function. During the contraction process, the forming ring body pulls and wraps the base material, and the wrapped base material pulls the autologous leaflets through the medical rivets d100, finally achieving the contraction repair of the autologous leaflets.
[0235] Obviously, the above embodiments are only examples given for clear illustration, rather than limitations on the implementation manners. For those of ordinary skill in the art, other different forms of changes or alterations can be made based on the above description. It is not necessary and impossible to exhaustively list all implementation manners here. And the obvious changes or alterations derived therefrom still fall within the protection scope of this invention.
Claims
1. A delivery system for a valve repair device, characterized in that: include: The pushing assembly comprises a primary handle (a1), a secondary handle (a2), and a tertiary handle (a3) arranged in sequence from the proximal end to the distal end; the secondary handle (a2) can rotate relative to the primary handle (a1), and the tertiary handle (a3) can slide back and forth relative to the secondary handle (a2); the primary handle (a1) is provided with a multi-lumen tube fixing seat (a101), a tangent mechanism (c00), a wire pulling mechanism (b01), a pushing mechanism, and a wire pulling mechanism (b02) in sequence from the distal end to the proximal end; The distal end of the multi-lumen tube fixing seat (a101) is connected to a multi-lumen tube (a107), and the pull wire mechanism (b01) is connected to a plurality of fixed guide pull wires that pass through the inner cavity of the multi-lumen tube (a107) and are connected to the valve repair device; A push button travel groove (a102) is provided on the outer wall of the first-level handle (a1); the pushing mechanism comprises a pushing member (a103) disposed in the first-level handle (a1), and a push rod push button (a104) connected to the pushing member (a103) and slidably connected to the push button travel groove (a102); a pushing tube (a105) for conveying a valve repair device is fixed to the distal end of the pushing member (a103), and the pushing tube (a105) passes through the multi-lumen tube fixing seat (a101) and extends toward the distal end; The wire cutting mechanism (c00) is used to cut the shaped guide wire at the distal end of the wire pulling mechanism (b01); The wire pulling mechanism (b02) is connected to a plurality of traction wires passing through the push tube (a105), and the traction wires are connected to stop pins passing through the delivery valve repair device; An outer sheath (a301), located on the periphery of the multi-lumen tube (a107) and fixed to the distal end of the third-level handle (a3); The wire pulling mechanism (b01) comprises: A wire pulling sleeve (b1) is installed in the inner cavity of the first-level handle (a1), comprising a first central through hole (b11) located in the center and extending therethrough, and a plurality of first circumferential through holes (b12) distributed circumferentially around the first central through hole (b11), wherein a first routing channel (b13) is provided between the first central through hole (b11) and any one of the first circumferential through holes (b12) for allowing the shaped guide wire to enter the first central through hole (b11); the pushing tube (a105) is passed through the first central through hole (b11); The wire guide block (b2) is arranged in the first central through hole (b11) and is located at the distal end of the wire sleeve (b1). It is provided with a plurality of wire outlet holes (b21) for the shaped guide wire to pass through. The positions of the plurality of wire outlet holes (b21) and the plurality of first circumferential through holes (b12) are arranged in a one-to-one correspondence.
2. The delivery system of the valve repair device according to claim 1, characterized in that: A rotating groove (a201) is provided on the inner wall of the distal end of the first-level handle (a1), and a rotating boss (a202) corresponding to the rotating groove (a201) is provided on the outer wall of the proximal end of the second-level handle (a2), and the rotating boss (a202) can rotate on the rotating groove (a201); a limiting block (a304) is provided on the inner wall of the distal end of the second-level handle (a2), and a travel groove (a305) corresponding to the limiting block (a304) is provided on the inner wall of the proximal end of the third-level handle (a3), and the limiting block (a304) can slide on the travel groove (a305).
3. The delivery system of the valve repair device according to claim 1, characterized in that: The outer sheath tube (a301) is provided with a main cavity (a302) and a secondary cavity (a303); the multi-cavity tube (a107) is located in the main cavity (a302); a circular cavity (a108) is provided in the center of the multi-cavity tube (a107); and a plurality of branch cavities (a109) are provided circumferentially of the circular cavity (a108); the push tube (a105) is a single cavity and is located in the circular cavity (a108); each branch cavity (a109) is for one of the fixed guide wires to pass through.
4. The delivery system of the valve repair device according to claim 3, characterized in that: The distal end of the tertiary handle (a3) is provided with an outer sheath fixing seat (a306) for mounting the outer sheath tube (a301), and the proximal end of the secondary handle (a2) is provided with an inner tube support seat (a203) for supporting the multi-lumen tube (a107); the multi-lumen tube (a107) and the push tube (a105) extend toward the proximal end through the inner tube support seat (a203).
5. The delivery system of the valve repair device according to claim 1, characterized in that: A connecting block (a204) is provided at the proximal end of the secondary handle (a2), and an anti-rotation boss (a206) and an eccentric hole (a208) are provided on the connecting block (a204). A receiving groove (a205) for receiving the connecting block (a204) is provided on the inner wall of the proximal end of the secondary handle (a2), and a connecting groove (a207) corresponding to the anti-rotation boss (a206) is provided on the edge of the receiving groove (a205).
6. The delivery system of the valve repair device according to claim 1, characterized in that: The proximal end surface of the multi-lumen tube fixing seat (a101) is connected to a multi-lumen tube blood sealing plate (d260), and a multi-lumen tube blood sealing gasket (d270) is further provided between the multi-lumen tube fixing seat (a101) and the multi-lumen tube blood sealing plate (d260).
7. The delivery system of the valve repair device according to claim 4, characterized in that: The secondary handle (a2) is provided with a rivet implantation branch end, and the proximal end of the rivet implantation branch end is provided with a rivet fixing seat (a212); a rivet guide tube (a213) is provided inside the secondary handle (a2), one end of the rivet guide tube (a213) passes through the inner tube support seat (a203) and is connected to the outer sheath fixing seat (a306) and communicates with the secondary cavity (a303); the other end of the rivet guide tube (a213) is connected to the rivet fixing seat (a212).
8. The delivery system of the valve repair device according to claim 1, characterized in that: A pin hole is provided at the connection between the secondary handle (a2) and the tertiary handle (a3), and a positioning pin (a214) for locking the secondary handle (a2) and the tertiary handle (a3) is provided on the pin hole.
9. The delivery system of the valve repair device according to claim 1, characterized in that: An angle mark (a106) is provided on the outer wall of the distal end of the primary handle (a1), and an indicating arrow for indicating the angle mark (a106) is provided on the outer wall of the proximal end of the secondary handle (a2).
10. The delivery system of the valve repair device according to claim 9, characterized in that: The side walls of the plurality of first circumferential through holes (b12) are each provided with a through-going wire drawing travel groove (b14); the wire drawing mechanism (b01) further comprises: A first rebound screw (b3) is coaxially arranged in the first circumferential through hole (b12); one end of the first rebound screw (b3) close to the wire guide block (b2) is connected to a wire turntable (b7) for winding the shaped guide wire; the other end of the first rebound screw (b3) is provided with a first rebound cap (b6) located near the proximal end of the wire sleeve (b1); A first screw stroke nut (b4) is threadedly sleeved on the outer periphery of the first rebound screw (b3) and slidably mounted on the wire drawing stroke groove (b14); a first guide extension block (b41) is provided on the first screw stroke nut (b4) and protrudes outward and slidably engages with the wire drawing stroke groove (b14); The first compression spring (b5) is sleeved on the first rebound screw (b3) and is located between the first screw stroke nut (b4) and the first rebound cap (b6); the elastic force of the first compression spring (b5) drives the first screw stroke nut (b4) to move toward the distal end of the first rebound screw (b3) to drive the first rebound screw (b3) to rotate in the first circumferential through hole (b12), and the wire pull turntable (b7) rotates with the rotation of the first rebound screw (b3) to keep the shaped guide wire wound thereon in a tensioned state.
11. The delivery system of the valve repair device according to claim 9, characterized in that: On a cross section perpendicular to the axial direction of the wire pulling sleeve (b1), a line connecting the center of the first central through hole (b11) and the center of the first circumferential through hole (b12) passes through the center of the wire pulling outlet hole (b21).
12. The delivery system of the valve repair device according to claim 10, characterized in that: A plurality of shaping guide wire outlet holes are provided on the outer wall of the first-level handle (a1), and a first locking wire pull block (b8) is provided on the shaping guide wire outlet holes. One end of the shaping guide wire is connected to the first locking wire pull block (b8), and the other end is connected to the wire pull turntable (b7).
13. The delivery system of the valve repair device according to claim 1, characterized in that: The wire pulling mechanism (b02) comprises: A wire pulling sleeve (b9) is installed in the inner cavity of the first-level handle (a1), comprising a second central through hole (b91) located in the center and extending therethrough, and a plurality of second circumferential through holes (b92) distributed circumferentially around the second central through hole (b91); The tail end wire splitter (b110) is mounted on the second center through hole (b91), and one end of the tail end wire splitter (b110) passes through the second center through hole (b91) from the proximal end of the wire pulling sleeve (b9), and is provided with a plurality of traction wire outlet holes (b111) for the traction wire to pass through; The wire pulling locking sleeve (b10) is installed on the second circumferential through hole (b92), and one end passes through the second circumferential through hole (b92) from the proximal end of the wire pulling sleeve (b9); the outer wall of the wire pulling locking sleeve (b10) is provided with a second wiring channel (b93) for the traction wire inside it to extend outward; the positions of multiple second wiring channels (b93) and multiple traction wire outlet holes (b111) are arranged in a one-to-one correspondence.
14. The delivery system of the valve repair device according to claim 13, characterized in that: A through-going pulling wire travel groove (b102) is provided on the side wall of the wire pulling locking sleeve (b10); A second rebound screw (b120) is coaxially arranged in the inner cavity of the wire pulling locking sleeve (b10); one end of the second rebound screw (b120) close to the wire pulling sleeve (b9) is connected to a traction wire turntable (b150) for winding the traction wire; the other end of the second rebound screw (b120) is provided with a second rebound cap (b140) located at the far end of the wire pulling locking sleeve (b10); A second screw stroke nut (b130) is threadedly sleeved on the outer periphery of the second rebound screw (b120) and slidably mounted in the traction line stroke groove (b102); a traction line guide block (b131) is provided on the second screw stroke nut (b130) and protrudes outward and slidably engages with the traction line stroke groove (b102); The second compression spring (b170) is sleeved on the second rebound screw (b120) and is located between the second screw stroke nut (b130) and the second rebound cap (b140); the elastic force of the second compression spring (b170) drives the second screw stroke nut (b130) to move toward the distal end of the second rebound screw (b120) to drive the second rebound screw (b120) to rotate in the inner cavity of the wire pulling locking sleeve (b10), and the traction wire turntable (b150) rotates with the rotation of the second rebound screw (b120) to keep the traction wire wrapped thereon in a tensioned state.
15. The delivery system of the valve repair device according to claim 13, characterized in that: A second center hole for the push tube (a105) to pass through is also provided in the middle of the tail end wire dividing piece (b110), and a plurality of the pulling line outlet holes (b111) are evenly arranged circumferentially on the outer periphery of the second center hole.
16. The delivery system of the valve repair device according to claim 15, characterized in that: The tail end wire splitting piece (b110) is fixed on the outer wall surface of the distal end of the wire pulling sleeve (b9), and the traction wire outlet hole (b111) is arranged to be inclined outward from the distal end to the proximal end of the tail end wire splitting piece (b110).
17. The delivery system of the valve repair device according to claim 13, wherein: The wire pulling locking sleeve (b10) is slidably installed in the second circumferential through hole (b92) along the axial direction of the second circumferential through hole (b92), and the wire pulling sleeve (b9) is provided with a locking button (b101) for locking the wire pulling locking sleeve (b10) on the second circumferential through hole (b92).
18. The delivery system of the valve repair device according to claim 14, characterized in that: A plurality of traction line outlet holes (b111) are provided on the outer wall of the first-level handle (a1), and a second locking line pull block (b160) is provided on the traction line outlet hole (b111). One end of the traction line is connected to the second locking line pull block (b160), and the other end is connected to the traction line turntable (b150).
19. The delivery system of the valve repair device according to claim 1, characterized in that: The tangent mechanism (c00) comprises: A reinforcing tube (c02) is provided with a plurality of wire holes (c021) extending along its axial direction, and the plurality of wire holes (c021) are arranged along the circumference of the reinforcing tube (c02); a wire-exposing groove (c022) communicating with the plurality of wire holes (c021) is provided on the outer peripheral wall of the reinforcing tube (c02); a reinforcing tube center hole (c024) for the push tube (a105) to pass through is also provided in the middle of the reinforcing tube (c02), and the plurality of wire holes (c021) are evenly arranged circumferentially around the outer periphery of the reinforcing tube center hole (c024); A blade fixing plate (c03) is fixed on the first-level handle (a1) and sleeved on the outer circumference of the reinforcement tube (c02), and a plurality of linear guide grooves (c031) are provided on one side of the blade fixing plate (c03); The blade rotating disk (c04) is sleeved on the outer periphery of the reinforcing tube (c02) along the axial rotation of the reinforcing tube (c02) and is arranged opposite to the blade fixing disk (c03); a plurality of arc-shaped guide grooves (c041) are provided on a side wall of the blade rotating disk (c04) facing the blade fixing disk (c03); the plurality of arc-shaped guide grooves (c041) and the plurality of linear guide grooves (c031) are arranged in a one-to-one correspondence; A plurality of cutting blades (c05) are located between the blade fixing disk (c03) and the blade rotating disk (c04) and are located on the same plane as the wire exposure groove (c022), and are connected to a blade guide rod (c051); one end of the blade guide rod (c051) extends into the linear guide groove (c031), and the other end extends into the corresponding arc guide groove (c041); During the rotation of the blade turntable (c04), the blade guide rods (c051) of the plurality of cutting blades (c05) are driven to slide simultaneously in the linear guide groove (c031) and the arc guide groove (c041), so that the cutting blades (c05) are moved closer to or away from the wire-exposing groove (c022) on the reinforcing tube (c02).
20. The delivery system of the valve repair device according to claim 19, characterized in that: The cutting blade (c05) is provided with a blade edge (c052) at one end close to the reinforcing tube (c02), and the blade edge (c052) is arc-shaped. The arcs where the multiple blade edges (c052) are located are all arranged concentrically with the wire-exposing groove (c022).
21. The delivery system of the valve repair device according to claim 20, characterized in that: The cutting blade (c05) has a first curved side surface located on one side of the blade edge (c052) and a second curved side surface located on the other side of the blade edge (c052); when multiple cutting blades (c05) extend into the wire exposure groove (c022), the first curved side surface of the cutting blade (c05) matches the second curved side surface of an adjacent cutting blade (c05), and the first curved side surface of the cutting blade (c05) matches the second curved side surface of another adjacent cutting blade (c05); the cutting blade (c05) is propeller-shaped.
22. The delivery system of the valve repair device according to claim 19, wherein: The outer wall of the first-level handle (a1) is provided with a cut-off button travel groove, and the outer side wall of the blade turntable (c04) is connected with a cut-off button (c06) extending out of the cut-off button travel groove.
23. The delivery system of the valve repair device according to claim 7, characterized in that: The rivet guide tube (a213) is connected to a rivet implantation device (d00); the rivet implantation device (d00) includes an integral rivet handle (d200), a rivet pushing handle (d300), a medical rivet (d100), and a rivet connecting tube (d400) connected to a release buckle (d140) of the medical rivet (d100); the rivet connecting tube (d400) extends into the rivet guide tube (a213).
24. The delivery system of the valve repair device according to claim 23, wherein: The medical rivet (d100) has a shape memory function, comprising: a puncture tip (d110), located at the distal end of the medical rivet (d100); a rivet barb (d120), located at one end of the side wall of the medical rivet (d100) close to the puncture tip (d110); A rivet avoidance groove (d130) is located on the outer wall of the medical rivet (d100) and is arranged corresponding to the position of the rivet barb (d120); A release buckle (d140), located at the proximal end of the medical rivet (d100), and used for connecting to the rivet connecting tube (d400); A reverse spring block (d150) is arranged at one end of the medical rivet (d100) close to the release buckle (d140); The rivet barb (d120) has an initial state in which the rivet barb (d120) is expanded outward in a natural state and the barb thereon is arranged toward the proximal end, and a loaded state in which the rivet barb (d120) is retracted into the rivet avoidance groove (d130) under the action of an external force; the reverse spring block (d150) has an initial state in which the reverse spring block (d150) is bent outward in a natural state and the end thereof away from the medical rivet (d100) is arranged toward the distal end, and a loaded state in which the reverse spring block (d150) is bent in the reverse direction toward the proximal end under the action of an external force.
25. The delivery system of the valve repair device according to claim 24, characterized in that: The reverse spring block (d150) is integrally formed with the medical rivet (d100); or the reverse spring block (d150) is at least two spring pieces welded to the outside of the medical rivet (d100); or the reverse spring block (d150) is an arched spring piece that passes through the middle of the medical rivet (d100) and is welded and fixed to the medical rivet (d100).
26. The delivery system of the valve repair device according to claim 24, characterized in that: A rivet pressing piece (d160) is coaxially sleeved on the outer side of the medical rivet (d100), and the rivet pressing piece (d160) is cylindrical; a plurality of outwardly protruding spikes (d161) are provided at the distal end of the rivet pressing piece (d160).
27. The delivery system of the valve repair device according to claim 26, wherein: The gap between the rivet pressing sheet (d160) and the medical rivet (d100) allows the covering tube (d500) to pass through, the distal end of the covering tube (d500) is provided with an opening groove (d510), and the inner side wall of the rivet pressing sheet (d160) is provided with a pressing sheet boss (d162) that is limitedly engaged with the opening groove (d510).
28. The delivery system of the valve repair device according to claim 23, wherein: The rivet integral handle (d200) includes a tube outlet end (d210) and a push end (d220), and a push cavity (d221) is provided inside the push end (d220); the front section of the rivet push handle (d300) extends into the push cavity (d221) and can reciprocate relative to the axial direction of the push cavity (d221); the rivet push handle (d300) is provided with a rivet connecting pipe connection cavity (d310), and the rivet connecting pipe connection cavity (d310) is provided inside the rivet pushing handle (d300). A rivet connecting tube fixing block (d311) is provided in the cavity (d310), and the rivet connecting tube (d400) passes through the tube outlet end (d210) and the pushing end (d220) and is fixedly connected to the rivet connecting tube fixing block (d311); a spring buckle (d340) is provided on the cavity wall of the pushing cavity (d221), and a stop boss (d330) that snaps into engagement with the spring buckle (d340) is provided on the outer wall of the front section of the rivet pushing handle (d300).
29. The delivery system of the valve repair device according to claim 28, wherein: The outer periphery of the rivet connecting tube (d400) is coaxially sleeved with a covering tube (d500), and the rivet pushing handle (d300) is further provided with a covering tube connecting cavity (d320), the covering tube connecting cavity (d320) is located at the distal end of the rivet connecting tube connecting cavity (d310), the covering tube connecting cavity (d320) is provided with a covering tube connecting slider (d321), and a rebound spring (d325) is provided between the covering tube connecting slider (d321) and the distal cavity wall of the covering tube connecting cavity (d320). ), a spring fixing block (d323) and a release button (d322) are further provided in the sheathed tube connection cavity (d320), and the release button (d322) and the spring fixing block (d323) are elastically connected via a release spring (d324); the sheathed tube connection slider (d321) can slide back and forth relative to the sheathed tube connection cavity (d320); the rivet connection tube (d400) passes through the sheathed tube connection slider (d321) and is fixedly connected to the rivet connection tube fixing block (d311).
30. The delivery system of the valve repair device according to claim 29, wherein: The outer periphery of the sheathing tube (d500) is coaxially sleeved with a bending adjustment tube (d600), and the integral rivet handle (d200) further comprises a first bending adjustment end (d230) and a second bending adjustment end connected to the tube outlet end (d210); the first bending adjustment end (d230) and the second bending adjustment end are both provided with a bending adjustment cavity (d250), a coaxial bending adjustment sliding guide rail (d251) is provided in the bending adjustment cavity (d250), and a bending control knob cap (d253) is provided at the proximal end of the bending adjustment cavity (d250), and the bending control knob cap (d253) is connected to the bending adjustment cavity (d250). The bending adjustment sliding guide rail (d251) is connected, and the outer periphery of the bending adjustment sliding guide rail (d251) is threadedly connected to a bending control lock wire nut (d252) that is slidably connected to the inner wall of the bending adjustment cavity (d250); rotating the bending control knob cap (d253) can drive the bending control lock wire nut (d252) to move back and forth along the axial direction of the bending adjustment sliding guide rail (d251); a bending control guide wire (d254) is connected to the bending control lock wire nut (d252), and the other end of the bending control guide wire (d254) is connected to the bending adjustment tube (d600).
31. The delivery system of the valve repair device according to claim 30, characterized in that: A bending adjustment fixing seat (d211) is fixed to one end of the pipe outlet end (d210) close to the first bending adjustment end (d230) and the second bending adjustment end, and one end of the bending adjustment pipe (d600) is fixedly connected to the bending adjustment fixing seat (d211). The bending adjustment fixing seat (d211) is provided with a bending adjustment fixing seat center hole for the covering pipe (d500) to pass through and a bending control guide wire groove (d212) for the bending control guide wire (d254) to pass through.
32. The delivery system of the valve repair device according to claim 31, wherein: The bending adjustment tube (d600) includes an outer layer (d610), an intermediate layer (d620) and an inner layer (d630) arranged in sequence from the outside to the inside, and the bending control guide wire (d254) is arranged in the intermediate layer (d620); the front section of the bending adjustment tube (d600) is provided with a first traction ring (d640) and a second traction ring (d650), the bending control guide wire (d254) of the first bending adjustment end (d230) is connected to the first traction ring (d640), and the bending control guide wire (d254) of the second bending adjustment end is connected to the second traction ring (d650).
33. The delivery system of the valve repair device according to claim 1, wherein: It also includes a support platform (e00) of a delivery system for conveying a valve repair device, including a base plate (e1), a rack slide (e2) arranged on the base plate (e1), and a first support (e4), a second support (e5), and a third support (e6) slidably arranged on the rack slide (e2), the first support (e4) being provided with a first sleeve (e7) for mounting the first-level handle (a1), the second support (e5) being provided with a second sleeve (e8) for mounting the second-level handle (a2), and the third support (e6) being provided with a third sleeve (e9) for mounting the tertiary handle (a3); the first sleeve (e7), the second sleeve (e8), and the third sleeve (e9) being located on the same straight line.
34. The delivery system of the valve repair device according to claim 33, wherein: The rack slide rail (e2) has a side of the gear teeth (e3) that is inclined, the first sleeve (e7) and the second sleeve (e8) are located on the same straight line inclined to the horizontal line, and the angle between the straight line and the horizontal line is the same as the inclination gradient of the rack slide rail (e2).
35. The delivery system of the valve repair device according to claim 34, wherein: The rack slide rail (e2) is provided with a slider (e10), the bottoms of the first support (e4) and the second support (e5) are fixed on the slider (e10), a gear (e11) meshing with the rack slide rail (e2) is installed on the slider (e10), and a locking member for pressing against the rack slide rail (e2) is connected to the side wall of the slider (e10).
36. The delivery system of the valve repair device according to claim 33, wherein: The first sleeve (e7), the second sleeve (e8) and the third sleeve (e9) are all provided with quick-locking bolts (e14).
Citation Information
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