Prosthesis conveying device and prosthesis system

Abstract

The invention provides a prosthesis conveying device and a prosthesis system.The prosthesis conveying device comprises a handle shell, a control wire, a moving shaft and a driving handle, the far end of the control wire is used for being connected with a prosthesis, and the moving shaft is movably contained in the handle shell and used for driving the control wire to move so as to drive the prosthesis to change the state; the driving handle can rotate relative to the handle shell so as to drive the wire clamping shaft to move and transmit external torque to the prosthesis, the driving handle comprises an overload protection assembly, and the overload protection assembly is used for transmitting torque below a threshold value to the wire clamping shaft and preventing torque above the threshold value from being transmitted to the moving shaft. According to the prosthesis conveying device, through the overload protection assembly, the problems that when the driving handle operates the prosthesis at the far end, excessive force is applied, so that a control wire is broken, the prosthesis loses efficacy and is damaged, or human tissue is injured are solved, and the reliability of a prosthesis system and the operation safety are improved.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and more specifically, relates to a prosthesis delivery device and a prosthesis system. Background Art

[0002] Minimally invasive treatment methods have the advantages of small wounds, less harm to patients, and fast postoperative recovery, so they are welcomed by the majority of patients. Prosthesis implantation is an important component of minimally invasive treatment methods. Generally speaking, the prosthesis system includes a delivery device and an implanted prosthesis located at the distal end of the delivery device. During the operation, the operator uses the delivery device to deliver the implanted prosthesis to the target location through the natural cavities of the human body such as veins. When the implanted prosthesis is released, the delivery device is separated from the implanted prosthesis, and then the delivery device is withdrawn to complete the interventional operation.

[0003] U.S. Patent No. 10076327B2 discloses a device, system and method for tissue approximation and treatment site repair. There are many problems with the technology related to this patent. For example, when the implanted prosthesis (such as a mitral valve clip) of the device is in a locked state, the unexpected rotation of the handle threaded rotor will cause the implanted prosthesis to be subjected to unexpected forces, which may easily lead to failure of the locked state or damage or popping of the implant due to the sudden release of the force when the lock is released; for another example, during the operation, the rotating handle threaded rotor exerts excessive force on the control wire (and the implanted prosthesis), causing the control wire to break, or the implanted prosthesis to fail or be damaged, or cause damage to human tissue. Summary of the invention

[0004] The purpose of the embodiments of the present invention is to provide a prosthesis delivery device and a prosthesis system to solve one or more of the above-mentioned technical problems.

[0005] To achieve the above-mentioned purpose, the technical solution adopted by the present invention is: the first aspect of the present invention provides a prosthesis delivery device, comprising: a handle shell; a control wire, the distal end of which is used to connect with the prosthesis; a movable shaft, movably accommodated in the handle shell, and used to drive the prosthesis to change state by driving the control wire to move; a driving handle, which can be rotated relative to the handle shell to drive the movable shaft to move and transmit external torque to the prosthesis, and the driving handle includes an overload protection component, and the overload protection component is configured to transmit torque below a threshold to the movable shaft, and prevent torque above the threshold from being transmitted to the movable shaft.

[0006] In one embodiment, the driving handle further includes a transmission member, the transmission member is threadedly engaged with the movable shaft to drive the movable shaft to move, and the overload protection component is sleeved on the outer side of the transmission member.

[0007] In one embodiment, the overload protection assembly comprises a support member, a passive member and an active member, wherein the passive member is circumferentially stationary relative to the transmission member and can move axially relative to the transmission member; the active member is axially stationary relative to the transmission member and can rotate circumferentially relative to the transmission member; the support member is used to keep the passive member and the active member in axial contact;

[0008] The passive component and the active component respectively include a first abutting surface and a second abutting surface, the first abutting surface and the second abutting surface are arranged correspondingly, the first abutting surface and the second abutting surface are planes at least in the abutting position, and the planes are not parallel to the axis of the driving handle.

[0009] In one embodiment, both the first abutting surface and the second abutting surface are planes perpendicular to the axis of the driving handle.

[0010] In one embodiment, the first abutting surface includes a first vertical surface, a first horizontal surface and a first inclined surface connected in sequence; the second abutting surface includes a second vertical surface, a second horizontal surface and a second inclined surface connected in sequence; the first vertical surface and the second vertical surface are both planes parallel to the axis of the driving handle, the first horizontal surface and the second horizontal surface are both planes perpendicular to the axis of the driving handle, and the first inclined surface and the second inclined surface are both planes arranged at an angle to the axis of the driving handle, and the angles are the same.

[0011] In one embodiment, the first abutting surface includes a first inclined surface and a third inclined surface connected to the first inclined surface; the second abutting surface includes a second inclined surface and a fourth inclined surface connected to the second inclined surface; the first inclined surface and the second inclined surface are both planes arranged at an angle to the axis of the driving handle, and the angles are the same, and the third inclined surface and the fourth inclined surface are both planes arranged at an angle to the axis of the driving handle, and the angles are the same.

[0012] In one embodiment, the overload protection assembly comprises a support member, a passive member and an active member, wherein the passive member is circumferentially stationary relative to the transmission member and can move axially relative to the transmission member; the active member is axially stationary relative to the transmission member and can rotate circumferentially relative to the transmission member; the support member is used to keep the passive member and the active member in axial contact;

[0013] The passive component and the active component respectively include a first abutting surface and a second abutting surface, the first abutting surface and the second abutting surface are arranged correspondingly, at least one of the first abutting surface and the second abutting surface is a curved surface at the abutting position, and the first abutting surface and the second abutting surface are circumscribed at the abutting position, and the circumscribed surface is not parallel to the axis of the driving handle.

[0014] In one embodiment, the passive component includes a first body and a first abutting portion, the first body is located at the distal end of the first abutting portion, and the first abutting surface is disposed at the proximal end surface of the first abutting portion;

[0015] The active member includes a second body and a second abutting portion, the second body is located at the proximal end of the second abutting portion, and the second abutting surface is arranged on the distal end surface of the second abutting portion.

[0016] In one embodiment, the diameter of the first abutting portion is greater than the diameter of the first body, and a first blocking shoulder is formed at a connection between the first abutting portion and the first body, and the first blocking shoulder is used to abut against the support member.

[0017] In one embodiment, the overload protection assembly also includes a accommodating seat, which is fixedly sleeved on the outside of the transmission member, and the support member, the active member and the passive member are coaxially sleeved on the outer surface of the accommodating seat; the accommodating seat includes a distal part, a middle part and a proximal part; the radial dimension of the distal part is larger than the radial dimension of the middle part, forming a distal shoulder, the radial dimension of the middle part is larger than the radial dimension of the proximal part, forming a proximal shoulder, the distal shoulder is used to support the support member, and the proximal shoulder is used to abut the passive member to prevent the passive member from moving too far toward the distal end.

[0018] In one embodiment, the support member is a spring, one end of the spring abuts against the distal shoulder, and the other end of the spring abuts against the first blocking shoulder.

[0019] In one embodiment, a first anti-rotation groove is provided on the first body of the passive component, and a first anti-rotation pin is provided on the outer surface of the proximal portion, and the first anti-rotation pin is axially movably accommodated in the first anti-rotation groove.

[0020] In one embodiment, the overload protection assembly further includes a transmission housing, which is coaxially sleeved on the outside of the active member to receive external torque and transmit it to the active member, and the active member is configured to remain circumferentially stationary relative to the transmission housing.

[0021] In one embodiment, a second anti-rotation groove is provided on the second body of the active member, and a second anti-rotation pin is provided on the inner wall of the transmission housing, and the second anti-rotation pin is axially movably accommodated in the second anti-rotation groove.

[0022] In one embodiment, the overload protection assembly further includes a accommodating cover, the distal end of the accommodating cover having an axially extending coupling portion, the proximal end of the accommodating cover having a circumferentially extending blocking portion, the coupling portion being coupled to the proximal end of the accommodating seat to removably fix the accommodating cover to the accommodating seat, and the blocking portion being used to keep the active member axially stationary relative to the transmission member.

[0023] In one embodiment, the handle shell includes an inner cavity, the proximal end of the handle shell is provided with an opening, the distal end of the transmission member is provided at the opening, and the transmission member is configured to be able to rotate only relative to the handle shell.

[0024] In one embodiment, the transmission member has a limiting protrusion located at the distal end and a limiting ridge located at the proximal end of the limiting protrusion, the limiting protrusion is circumferentially arranged on the transmission member and located inside the handle housing, the limiting ridge is circumferentially arranged on the transmission member and located outside the handle housing, and the limiting protrusion and the limiting ridge form an open groove;

[0025] The opening is contracted to form an opening shoulder, and the opening shoulder is accommodated in the opening groove.

[0026] A second aspect of the present invention provides a prosthesis system, comprising the prosthesis delivery device and a prosthesis as described above.

[0027] The prosthesis delivery device provided by the present invention includes a handle housing, a control wire, a movable shaft and a driving handle, wherein the distal end of the control wire is used to connect with the prosthesis, the movable shaft is movably accommodated in the handle housing, and is used to drive the prosthesis to change state by driving the control wire to move, the driving handle can rotate relative to the handle housing to drive the movable shaft to move, and transmit external torque to the prosthesis, and the driving handle includes an overload protection component, and the overload protection component is used to transmit torque below a threshold to the movable shaft, and prevent torque above a threshold from being transmitted to the movable shaft. The prosthesis delivery device solves the problem of excessive force applied by the driving handle to operate the distal prosthesis, resulting in breakage of the control wire, failure or damage of the prosthesis, or damage to human tissue, through the overload protection component, thereby improving the reliability of the prosthesis system and the safety of operation. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0029] Figure 1A schematic diagram of the partial structure of the proximal end of a prosthesis delivery device provided by one embodiment of the present invention;

[0030] Figure 2 A structural cross-sectional view of a driving handle in a prosthesis delivery device provided by one embodiment of the present invention;

[0031] Figure 3 A schematic diagram of the cooperation between the passive component and the active component in the prosthesis delivery device provided by one embodiment of the present invention;

[0032] Figure 4 A schematic diagram of the structure of a passive component in a prosthesis delivery device provided in one embodiment of the present invention;

[0033] Figure 5 A schematic diagram of assembling active components and passive components in a prosthesis delivery device provided in one embodiment of the present invention;

[0034] Figure 6 A schematic diagram of the structure of a passive component, an active component and a receiving seat of a prosthesis delivery device provided by an embodiment of the present invention after being assembled;

[0035] Figure 7 A schematic diagram of the structure of an overload protection assembly of a prosthesis delivery device provided in one embodiment of the present invention;

[0036] Figure 8 A schematic diagram of the torque transmission principle of a prosthesis delivery device provided by one embodiment of the present invention;

[0037] Fig. 9 A schematic structural diagram of a mitral valve clip provided by one embodiment of the present invention;

[0038] Fig.10 A schematic diagram of the structure of a mitral valve clip provided by an embodiment of the present invention when the clip arms are closed;

[0039] Fig.11 A schematic diagram of the structure of a mitral valve clip when the clip arms are deployed, provided in one embodiment of the present invention. DETAILED DESCRIPTION

[0040] In order to make the purpose, technical solution and advantages of the embodiments of the present invention clearer, the technical solution in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0041] In the description of the present invention, it should be understood that the terms "including" and "having" and any variations thereof used herein are intended to cover non-exclusive inclusions. For example, a process, method, system, product or apparatus comprising a series of steps or units is not necessarily limited to those steps or units explicitly listed, but may include other steps or units not explicitly listed or inherent to these processes, methods, products or apparatuses.

[0042] In addition, in the present application, unless otherwise clearly stipulated and limited, the terms "connect", "connected", "fixed", "installed", etc. should be understood in a broad sense. For example, it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium; it can be the internal connection of two elements or the interaction relationship between two elements. Unless otherwise clearly defined, ordinary technicians in this field can understand the specific meanings of the above terms in this application according to the specific circumstances.

[0043] It should be understood that the orientation or position relationship indicated by terms such as "length", "width", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside" and "outside" are based on the orientation or position relationship shown in the drawings, and are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operate in a specific orientation, and therefore cannot be understood as a limitation on the present invention.

[0044] In addition, the terms "first" and "second" are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of the indicated technical features. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of the features. In the description of the present invention, unless otherwise specified, "plurality" means two or more.

[0045] A prosthesis delivery device provided by one embodiment of the present invention includes a handle housing, a control wire, a movable shaft and a driving handle; the distal end of the control wire is used to connect to the prosthesis; the movable shaft is movably accommodated in the handle housing, and is used to drive the prosthesis to change its state by driving the control wire to move; the driving handle can be rotated relative to the handle housing to drive the movable shaft to move and transmit external torque to the prosthesis, and the driving handle includes an overload protection component, which is configured to transmit torque below a threshold to the movable shaft and prevent torque above the threshold from being transmitted to the movable shaft.

[0046] The prosthesis delivery device in this embodiment solves the problem of excessive force applied by the driving handle to operate the distal prosthesis, resulting in breakage of the control wire, failure or damage of the prosthesis, or injury to human tissue through the overload protection component, thereby improving the reliability of the prosthesis system and the safety of operation.

[0047] An embodiment of the present invention provides a prosthesis system comprising the above-mentioned prosthesis delivery device and a prosthesis.

[0048] In the following embodiments, the prosthesis is described in detail by taking a mitral valve clip for treating mitral valve regurgitation as an example to explain the prosthesis delivery device and prosthesis system provided by the present invention. Among them, the prosthesis is a leaflet clamping device for treating mitral valve regurgitation, which does not constitute a limitation on the protection scope of the present invention. The prosthesis can also be a tricuspid valve clip, an abdominal aortic stent, a thoracic aortic stent, a left atrial appendage occluder or an intracranial coil, etc.

[0049] In various embodiments of the present invention, the term "distal end" refers to the end away from the operator during the surgical operation, and the term "proximal end" refers to the end close to the operator during the surgical operation. Unless otherwise defined, all technical and scientific terms used in the present invention have the same meanings as those commonly understood by those skilled in the art to which the present invention belongs. The terms used in the specification of the present invention are only for the purpose of describing specific embodiments and are not intended to limit the present invention.

[0050] Figure 1 A schematic diagram of the partial structure of the proximal end of a prosthesis delivery device provided by an embodiment of the present invention. Figure 2 A schematic diagram of the structure of a driving handle in a prosthesis delivery device provided in one embodiment of the present invention. Fig. 9 This is a schematic diagram of the structure of the mitral valve clip provided by an embodiment of the present invention. Figure 1 , Figure 2 , Fig. 9 The prosthesis system provided in this embodiment includes a prosthesis delivery device 1 and a prosthesis 2. In this embodiment, the prosthesis 2 is a mitral valve clip.

[0051] See also Figure 1 , 2 The delivery device 1 provided in this embodiment includes a handle shell 11, a control wire 12, a movable shaft 13 and a driving handle 14. The distal end of the control wire 12 is used to connect with the prosthesis. The movable shaft 13 is movably accommodated in the handle shell 11, and is used to drive the prosthesis to change its state by driving the control wire 12 to move. The driving handle 14 can rotate relative to the handle shell 11 to drive the movable shaft 13 to move and transmit external torque to the prosthesis. The driving handle 14 includes an overload protection component 141. The overload protection component 141 is configured to transmit torque below a threshold to the movable shaft 13 and prevent torque above a threshold from being transmitted to the movable shaft 13.

[0052] Here, the state change of the prosthesis may refer to the change of the shape, size, and posture relationship of the prosthesis as a whole, for example, the stent changes from a compressed state to a released state. Exemplarily, a binding wire is set on the abdominal aortic stent and the thoracic aortic stent to bind the abdominal aortic stent and the thoracic aortic stent to maintain a compressed state. When the abdominal aortic stent and the thoracic aortic stent are implanted in the target position, the control wire 12 pulls the binding wire and separates the abdominal aortic stent and the thoracic aortic stent to make the abdominal aortic stent and the thoracic aortic stent become a released state. The state change of the prosthesis may refer to the change of the connection relationship between the prosthesis and the delivery device and the target tissue, for example, from a connected state to a separated state. Exemplarily, when delivering a left atrial appendage occluder and an intracranial coil, the control wire 12 is in a connected state with the left atrial appendage occluder and the intracranial coil. After the left atrial appendage occluder and the intracranial coil are released, the control wire 12 is driven to separate from the left atrial appendage occluder and the intracranial coil, and the left atrial appendage occluder and the intracranial coil are in a released state. The state change of the prosthesis may also be a change in the shape or size of some components, parts or parts of the prosthesis, or a change in position relative to the rest of the prosthesis. For example, in this embodiment, the axial movement of the control wire 12 drives the clamp arm 22 of the mitral valve clip to swing.

[0053] When the delivery device of this embodiment is used in surgery to treat mitral regurgitation, the prosthetic delivery device 1 transmits torque below the threshold to the movable shaft 13 through the overload protection component 141, and prevents torque above the threshold from being transmitted to the movable shaft 13. This can solve the problem of excessive force applied by the driving handle 14 to open or close the distal mitral valve clip, and prevent the force from being transmitted to the distal mitral valve clip, which may cause the control wire 12 to break, or cause the opening angle or closing angle of the clamp arm 22 in the mitral valve clip to exceed the physical limit, causing the mitral valve clip to be damaged or fail, and may even break the edges of the anterior and posterior lobes of the mitral valve, causing damage to the mitral valve leaflets.

[0054] Fig. 9 A schematic diagram of the structure of a mitral valve clip provided by an embodiment of the present invention, Fig.10 A schematic diagram of the structure of a mitral valve clip when the clip arms are closed according to an embodiment of the present invention. Fig.11 This is a schematic diagram of the structure of the mitral valve clip provided by one embodiment of the present invention when the clip arms are deployed. Figure 9-11The prosthesis 2 of this embodiment, i.e., the mitral valve clip, includes a central base 21, a clamp arm 22, and a clamp 23. The clamp arm 22 and the clamp 23 can respectively perform opening and closing movements (i.e., change states) around the axis of the central base 21 to clamp or release the leaflets 3 of the mitral valve. The clamp arm 22 of the mitral valve clip of this embodiment includes a first clamp arm 221 and a second clamp arm 222, and the first clamp arm 221 and the second clamp arm 222 are symmetrically arranged about the axis of the central base 21. Correspondingly, the clamp 23 of the mitral valve frame of this embodiment includes a first clamp 231 and a second clamp 232, and the first clamp 231 is used to cooperate with the first clamp arm 221 to clamp one leaflet in the mitral valve, and the second clamp 232 is used to cooperate with the second clamp arm 222 to clamp another leaflet in the mitral valve. In this embodiment, the central base 21 is detachably connected to the distal end of the delivery device. This embodiment does not limit the specific implementation method of the detachable connection.

[0055] Further, the prosthesis 2 also includes an actuating assembly 24, which is used to drive the clamping arm 22 to open and close around the central base 21 under the drive of the control wire 12, so that the clamping arm 22 and the clamping arm connecting rod 23 clamp or release the valve leaf 3. Specifically, the actuating assembly 24 of this embodiment includes a first connecting rod 241, a second connecting rod 242 and a base 243, wherein one end of the first connecting rod 241 is rotatably connected to the first clamping arm 221, and the other end is rotatably connected to the base 243; one end of the second connecting rod 242 is rotatably connected to the second clamping arm 222, and the other end is rotatably connected to the base 243, and the base 243 includes a horizontal part and a vertical part, and the two ends of the horizontal part are respectively connected to the first connecting rod 241 and the second connecting rod 242, and the vertical part is accommodated in the hollow central base 21 and can move relative to the central base 21. Specifically, the base 243 of this embodiment is in a "T" shape, and the two ends of the horizontal part of the base 243 are respectively connected to the first connecting rod 241 and the second connecting rod 242, and the vertical part is accommodated in the central base 21 and can move relative to the central base 21. For example, the first connecting rod 241, the second connecting rod 242, the first clamping arm 221, the second clamping arm 222, the base 243, and the central base 21 form a connecting rod structure in a pin-shaft connection manner, and the vertical part is detachably connected to the control wire 12. Under the action of the control wire 12, the base 243 moves relative to the central base 21, thereby causing the first clamping arm 221 and the second clamping arm 222 to rotate to achieve clamping of the edge of the leaflet 3.

[0056] Exemplarily, the distal end of the control wire 12 has an external thread, and correspondingly, the vertical portion has an internal thread matching therewith, and the control wire 12 and the vertical portion of the base 243 are detachably connected by the threaded cooperation of the external thread and the internal thread. Of course, in other alternative embodiments, the distal end of the control wire 12 may be provided with an internal thread, and the vertical portion of the base 243 may be provided with an external thread matching therewith.

[0057] Continue reading Figure 1 and Figure 2 In this embodiment, the moving shaft 13 is configured to be able to move axially only relative to the handle housing 11, and the driving handle 14 is configured to be able to make rotational motion only relative to the handle housing 11, and the axial movement of the moving shaft 13 is driven by the rotational motion of the driving handle 14. Specifically, the handle housing 11 includes an inner cavity, and the proximal end of the handle housing 11 is provided with an opening, which is retracted to form an opening shoulder 111. The driving handle 14 includes a hollow transmission member 142, and the distal end of the transmission member 142 is provided with an opening groove 1423 extending circumferentially, and the opening shoulder 111 is accommodated in the opening groove 1423, so that the driving handle 14 is restricted and can only rotate relative to the handle housing 11. Furthermore, the transmission member 142 has a limiting protrusion 1421 at the distal end, the limiting protrusion 1421 is circumferentially arranged on the transmission member 142 and located inside the handle housing 11; on the proximal side of the limiting protrusion 1421, the transmission member 142 is provided with a limiting ridge 1422, the limiting ridge 1422 is circumferentially arranged on the transmission member 142 and located outside the handle housing 11. In this way, the limiting protrusion 1421 and the limiting ridge 1422 form the above-mentioned opening groove 1423.

[0058] On the other hand, the distal end of the movable shaft 13 enters the inner cavity of the handle housing 11 through the proximal opening, and the distal end of the movable shaft 13 passes through the transmission member 142. Further, a first limiting member is provided on the outer side of the distal end of the movable shaft 13, and a second limiting member is provided at a corresponding position of the handle housing 11. The first limiting member and the second limiting member are configured to be connected along the axial movement of the driving handle 14, so that the movable shaft 13 is restricted and can only move axially relative to the driving handle 14. The inner wall of the transmission member 142 is provided with an internal thread, and correspondingly, the outer wall of the movable shaft 13 is provided with an external thread. Through the threaded fit, the axial movement of the movable shaft 13 is driven by the rotation of the driving handle 14.

[0059] As described above, in this embodiment, the control wire 12 and the movable shaft 13 remain relatively stationary in the axial direction, and the torque applied to the movable shaft 13 is transmitted to the mitral valve clip connected to the control wire 12 at the distal end, so as to realize the opening and closing of the clamp arms in the mitral valve clip (i.e., the change of the state of the mitral valve clip). In other embodiments, the movement of the control wire 12 realizes the release of the prosthesis 2 from the delivery device 1, or realizes the adjustment of the position of the prosthesis 2, or realizes the change of the loading of the prosthesis 2 (e.g., from a compressed state to an expanded state), etc. The control wire 12 of this embodiment can be made of metal wire, such as nickel titanium or stainless steel.

[0060] In this embodiment, the movable shaft 13 is provided with a receiving cavity, and the control wire 12 is fixedly received in the receiving cavity, so that the control wire 12 and the movable shaft 13 remain relatively stationary in the axial direction. In an alternative embodiment, the prosthesis delivery device also includes a wire clamping shaft, which is used to fix the control wire 12, and the wire clamping shaft is rotatably received in the receiving cavity of the movable shaft 13. When the movable shaft 13 drives the control wire 12 to move axially, the wire clamping shaft and the movable shaft are fixed by fixing parts such as a latch. Further, the overload protection component 141 is sleeved on the outer side of the transmission member 142, and the overload protection component 141 is used to transmit torque below the threshold to the transmission member 142, and prevent torque above the threshold from being transmitted to the transmission member 142. In this embodiment, the torque applied to the overload protection component 141 is transmitted to the movable shaft 13 through the transmission member 142, and then transmitted to the mitral valve clip through the control wire 12 to realize the opening and closing of the clamp arm.

[0061] See also Figure 2-Figure 5 The overload protection assembly 141 includes a support member 41, a passive member 42 and an active member 43. The passive member 42 remains circumferentially stationary relative to the transmission member 142 and can move axially relative to the transmission member 142; the active member 43 remains axially stationary relative to the transmission member 142 and can rotate circumferentially relative to the transmission member 142; the support member 41 is used to keep the passive member 42 and the active member 43 in axial contact. In this embodiment, the passive member 42 and the active member 43 respectively include a first contact surface A and a second contact surface B, and the first contact surface A and the second contact surface B are correspondingly arranged, and the first contact surface A and the second contact surface B are planes at least in the contact portion, and the planes are not parallel to the axis of the driving handle 14. For example, the first contact surface A and the second contact surface B are both planes perpendicular to the axis of the driving handle 14. For another example, as Figure 4As shown, the first abutting surface A includes a first vertical surface, a first horizontal surface and a first inclined surface connected in sequence, and the first vertical surface, the first horizontal surface and the first inclined surface define a first meshing tooth with a right-angled trapezoidal cross-section. At the corresponding position, the second abutting surface B includes a second vertical surface, a second horizontal surface and a second inclined surface connected in sequence, and the second vertical surface, the second horizontal surface and the second inclined surface define a second meshing tooth with a right-angled trapezoidal cross-section, wherein the first vertical surface and the second vertical surface are both planes parallel to the axis of the driving handle 14, the first horizontal surface and the second horizontal surface are both planes perpendicular to the axis of the driving handle 14, the first inclined surface and the second inclined surface are both planes arranged at an angle to the axis of the driving handle 14, and the angles are the same, the first vertical surface can abut against the second vertical surface, the first horizontal surface can abut against the second horizontal surface, and the first inclined surface can abut against the second inclined surface. When the first abutting surface A and the second abutting surface B of this embodiment abut, the first meshing teeth of the right-angled trapezoidal shape mesh with the second meshing teeth of the right-angled trapezoidal shape, when the passive member 42 and the active member 43 rotate in one direction, the first horizontal plane abuts with the second horizontal plane, and the first inclined plane abuts with the second inclined plane, which can prevent overload; when the passive member 42 and the active member 43 rotate in another direction, the first vertical plane abuts with the second vertical plane, which cannot prevent overload. See the following description for details. For another example, the first abutting surface A includes a first inclined surface and a third inclined surface connected to the first inclined surface, the first inclined surface and the third inclined surface are connected to define a first meshing tooth with a triangular cross section, and at a corresponding position, the second abutting surface B includes a second inclined surface and a fourth inclined surface connected to the second inclined surface, the second inclined surface and the fourth inclined surface are connected to define a second meshing tooth with a triangular cross section, wherein the first inclined surface and the second inclined surface are both planes arranged at an angle to the axis of the driving handle 14, and the angles are the same, the third inclined surface and the fourth inclined surface are both planes arranged at an angle to the axis of the driving handle 14, and the angles are the same, the first inclined surface can abut against the second inclined surface, and the third inclined surface can abut against the fourth inclined surface. In this way, when the first abutting surface A and the second abutting surface B abut, the triangular first meshing tooth and the triangular second meshing tooth mesh, and when the passive component 42 and the active component 43 rotate in two directions, the first inclined surface abuts against the second inclined surface, or the third inclined surface abuts against the fourth inclined surface, both of which can prevent overload. In addition to surface contact, the first abutting surface A and the second abutting surface B can also be line contact or point contact. In an alternative embodiment, the first abutting surface A and the second abutting surface B are arranged correspondingly, and at least one of the first abutting surface A and the second abutting surface B is a curved surface at the abutting position, and the first abutting surface A and the second abutting surface B are circumscribed at the abutting position, and the circumscribed surface is not parallel to the axis of the driving handle 14. For example, the first abutting surface A is in the shape of an arc, and the second abutting surface B is also in the shape of an arc, and the radii of the two are equal. For another example, the shapes of the first abutting surface A and the second abutting surface B can refer to the shape of the gear teeth in the externally meshing gear set. Preferably, the first abutting surface A and the second abutting surface B are sandblasted to increase the surface roughness.

[0062] For details, please continue to see Figure 2-5 , the passive member 42 is a hollow structure and is located at the proximal end of the transmission member 142. The passive member includes a first body 421 and a first abutting portion 422, and the first body 421 is located at the distal end of the first abutting portion 422. The first abutting surface A is arranged at the proximal end face of the first abutting portion 422. Further, the diameter of the first abutting portion 422 is greater than the diameter of the first body 421, so that the contact area of ​​the first abutting surface A can be increased, and a first blocking shoulder 423 can be formed at the connection between the first abutting portion 422 and the first body 421, and the first blocking shoulder 423 is used to abut the support member 41. Correspondingly, the active member 43 is also a hollow structure and is located at the proximal end of the passive member. The active member includes a second body 431 and a second abutting portion 432, and the second body 431 is located at the proximal end of the second abutting portion 432. The second abutting surface B is arranged at the distal end face of the second abutting portion 432.

[0063] Furthermore, the overload protection component 141 also includes a accommodating seat 44, which is a hollow structure and is fixedly sleeved on the outer side of the transmission member 142. As the basis of the overload protection component 141, the support member 41, the passive member 42 and the active member 43 are all sleeved on the outer surface of the accommodating seat 44. And at least the active member 43 can rotate circumferentially relative to the accommodating seat 44. The accommodating seat 44 of this embodiment is fixedly connected to the transmission member 142 by welding, bonding, etc. In other embodiments, the accommodating seat 44 can be integrally formed with the transmission member 142.

[0064] The accommodating seat 44 of this embodiment includes a distal portion 442, a middle portion 441 and a proximal portion 443. The radial dimension of the distal portion 442 is greater than the radial dimension of the middle portion 441, forming a distal shoulder; the radial dimension of the middle portion 441 is greater than the radial dimension of the proximal portion 443, forming a proximal shoulder. Among them, the distal shoulder is used to support the support member 41. The proximal shoulder is used to abut the passive member 42 to prevent the passive member 42 from moving too far to the distal end. The distal shoulder of this embodiment can provide support for the support member 41, and the support member 41 elastically supports the passive member, providing axial movement limit for the passive member 42 and the active member 43. Preferably, the distal portion 442 is fixedly connected to the limiting ridge 1421 to increase the fixing effect between the accommodating seat 44 and the transmission member 142. Here, "radial" does not mean that the distal portion 442, the middle portion 441 and the proximal portion 443 must be circular outer surfaces. For non-circular surfaces, it refers to the vertical direction from the edge to the axis.

[0065] Preferably, see Figure 2The support member 41 is a compression spring, one end of which abuts against the distal shoulder of the accommodating seat 44, and the other end of which abuts against the first blocking shoulder 423 of the passive member 42. The support member 41 of this embodiment is a compression spring, which is easy to obtain and has low cost.

[0066] See also Figure 3-Figure 6 , an axially extending first anti-rotation groove 4211 is provided on the first body 421 of the passive component 42, and a first anti-rotation pin 4411 is provided on the outer surface of the proximal portion 443, and the first anti-rotation pin 4411 is configured to be axially movably accommodated in the first anti-rotation groove 4211. In this way, the passive component 42 of this embodiment can remain circumferentially stationary relative to the accommodating seat 44, and can move axially relative to the accommodating seat 44. Since the accommodating seat 44 is fixedly connected to the transmission component 142, the passive component 42 can remain circumferentially stationary relative to the transmission component 142, and can move axially relative to the transmission component 142.

[0067] Please continue reading Figure 2 The overload protection assembly 141 also includes a transmission housing 45, which is coaxially sleeved on the outside of the active member 43 to receive external torque and transmit it to the active member 43. Preferably, the transmission housing 45 also covers the passive member 42, the receiving seat 44, etc. to prevent foreign matter from entering. The active member 43 is configured to remain circumferentially stationary relative to the transmission housing 45. The active member 43 and the transmission housing 45 of this embodiment rotate synchronously. The operator drives the active member 43 to rotate by driving the transmission housing 45. The passive member 42 abuts against the active member 43, and the active member 43 drives the passive member 42 to rotate. The passive member 42 synchronously drives the receiving seat 44 and the transmission member 142 to rotate. Preferably, please refer to Figure 7 The outer surface of the transmission housing 45 is provided with an anti-skid structure 452, which can increase the friction force when the operator applies torque to the transmission housing 45 to prevent slipping.

[0068] Please continue reading Figures 2 to 7 , an axially extending second stop groove 4311 is provided on the second body 431 of the active member 43, and a second stop pin 451 is provided on the inner wall of the transmission housing 45, and the second stop pin 451 is axially movably accommodated in the second stop groove 4311. In this embodiment, by providing the second stop groove 4311 on the second body 431 and the second stop pin 451 on the inner wall of the transmission housing 45, the second stop groove 4311 and the second stop pin 451 cooperate to achieve that the active member 43 and the transmission housing 45 remain relatively stationary in the circumferential direction and rotate synchronously, and the implementation method is simple. In other alternative embodiments, the active member 43 can also be fixedly connected to the transmission housing 45.

[0069] Preferably, the number of the first anti-rotation groove 4211 and the first anti-rotation pin 4411 are both multiple, and the first anti-rotation groove 4211 is evenly spaced in the circumferential direction of the first body 421; the number of the second anti-rotation groove 4311 and the second anti-rotation pin 451 are both multiple, and the second anti-rotation groove 4311 is evenly spaced in the circumferential direction of the second body 431. In this embodiment, the number of the first anti-rotation groove 4211 and the first anti-rotation pin 4411, as well as the number of the second anti-rotation groove 4311 and the second anti-rotation pin 451 are both multiple, which can improve the overall structural strength of the overload protection component 141. In this embodiment, the specific number of the first anti-rotation groove 4211 and the first anti-rotation pin 4411, as well as the specific number of the second anti-rotation groove 4311 and the second anti-rotation pin 451 are not particularly limited. Preferably, the number of the first anti-rotation groove 4211 and the first anti-rotation pin 4411 in this embodiment is both two, and the two first anti-rotation grooves 4211 are symmetrically arranged about the central axis of the passive component 42. In this embodiment, the number of the second anti-rotation groove 4311 and the second anti-rotation pin 451 are both two, and the two second anti-rotation grooves 4311 are symmetrically arranged about the central axis of the active member 43.

[0070] Please continue reading Figure 2 The overload protection assembly 141 further includes a housing cover 46, the distal end of the housing cover 46 has a coupling portion 461, the proximal end of the housing cover 46 has a blocking portion 462, the coupling portion 461 is coupled with the proximal end of the housing seat 44 to detachably fix the housing cover 46 to the housing seat 44, and the blocking portion 462 is used to keep the active member 43 axially stationary relative to the transmission member 142. Specifically, the housing cover 46 of this embodiment and the housing seat 44 are connected by a snap connection or a threaded connection. Figure 2 As shown, the coupling portion 461 is provided with an external thread, and the proximal portion of the accommodating seat 44 is provided with an internal thread. The radial dimension of the blocking portion 462 of this embodiment is greater than the radial dimension of the second body 431 of the active member 43, thereby forming a second blocking shoulder. When the coupling portion 461 is threadedly connected with the proximal portion, the second blocking shoulder abuts against the proximal end of the second body 431, so that the blocking portion 462 can prevent the active member 43 and the transmission housing 45 from axially moving.

[0071] Combine the following Figure 2-Figure 8 The overload protection principle of the overload protection component in the prosthesis delivery device of this embodiment is described as follows:

[0072] The external torque is transmitted to the active member 43 through the cooperation of the second stop pin 451 and the second stop groove 4311, and then transmitted to the passive member 42 through the cooperation of the first abutting surface A with a right-angled trapezoidal cross section and the second abutting surface B with a right-angled trapezoidal cross section. The passive member 42 transmits the torque to the accommodating seat 44 through the cooperation of the first stop pin 4411 and the first stop groove 4211, and then the accommodating seat 44 transmits the torque to the transmission member 142. The transmission member 142 rotates, and through the threaded transmission, the movable shaft 13 and the control wire 12 move axially toward the distal end (or proximal end).

[0073] 1) When a counterclockwise torque is applied to the transmission housing 45 (such as Figure 5 , Figure 7 As shown, observed from the proximal end to the distal end), the first vertical surface in the first abutting surface A of the passive component 42 and the second vertical surface in the second abutting surface B of the active component 43 abut against each other. Since the first vertical surface and the second vertical surface are parallel to the axis, that is, perpendicular to the tangential direction of the passive component 42 and the active component 43, no matter how large the torque is transmitted, the force direction of the passive component 42 is always along the tangential direction without axial force, and the passive component 42 and the active component 43 will never rotate relative to each other (that is, "slipping"). Therefore, the overload protection component 141 with a first meshing tooth of a right-angled trapezoid and a second meshing tooth with a right-angled trapezoidal cross-section has no overload protection function when transmitting a counterclockwise torque.

[0074] 2) When a clockwise torque is applied to the transmission housing 45, the second inclined surface of the second abutting surface B of the active member 43 abuts the first inclined surface of the first abutting surface A of the passive member 42, or the second horizontal surface of the second abutting surface B of the active member 43 abuts the first horizontal surface of the first abutting surface A of the passive member 42. Figure 8 As shown, the active member 43 transmits torque to the passive member 42 through the contact between the second inclined surface and the first inclined surface. 扭力 is the torque corresponding to the external moment, F 压力 Because the passive member 42 abuts against the active member 43 under the action of the supporting member, the active member 43 exerts a reaction pressure on the passive member 42. 扭力-1 F 扭力 Component along the first slope, F 扭力-2 F is perpendicular to the first slope 扭力 Component force. F 压力-1 F 压力 Component along the first slope, F 压力-2 F 压力 The component of force perpendicular to the direction of the first inclined plane.

[0075] When the torque is below the threshold, F 扭力-1 With F 压力-1 The resultant force is lower than the static friction between the passive member 42 and the active member 43, that is, F扭力-1 -F 压力-1 <(F 扭力-2 +F 压力-2 )×f, where f is the static friction coefficient. At this time, the passive member 42 and the active member 43 remain in meshing and transmit the torque to the receiving seat 44 and the transmission member 142 until the rotational motion is converted into the linear motion of the moving shaft 13 and the control wire 12.

[0076] When the torque is higher than the threshold, F 扭力-1 With F 压力-1 The resultant force exceeds the maximum static friction between the passive member 42 and the active member 43, that is, F 扭力-1 -F 压力-1 ≥(F 扭力-2 +F 压力-2 )×f, where f is the static friction coefficient. At this time, the passive component 42 and the active component 43 produce relative motion in the circumferential direction, and the active component 43 cannot transmit the torque to the passive component 42, and idle rotation and "slipping" occur, and the corresponding moving shaft 13 and the control wire 12 are no longer controlled and move, thereby achieving the purpose of overload protection.

[0077] The prosthesis delivery device provided by the embodiment of the present invention includes a handle housing, a control wire, a movable shaft and a driving handle, wherein the distal end of the control wire is used to connect with the prosthesis, the movable shaft is movably accommodated in the handle housing, and is used to drive the prosthesis to change state by driving the control wire to move, the driving handle can rotate relative to the handle housing to drive the movable shaft to move, and transmit external torque to the prosthesis, and the driving handle includes an overload protection component, and the overload protection component is used to transmit torque below the threshold to the movable shaft, and prevent torque above the threshold from being transmitted to the movable shaft. The prosthesis delivery device solves the problems of excessive force applied by the driving handle to the distal end of the prosthesis, resulting in breakage of the control wire, failure or damage of the prosthesis, or damage to human tissue, through the overload protection component, thereby improving the reliability of the prosthesis system and the safety of operation.

[0078] In the above description, the description with reference to the terms "an embodiment", "some embodiments", "example", "specific example" and the like means that the specific features, structures, materials or characteristics described in conjunction with the embodiment or example are included in at least one embodiment or example of the present invention. In this specification, the schematic representations of the above terms do not necessarily refer to the same embodiment or example. Moreover, the specific features, structures, materials or characteristics described may be combined in any one or more embodiments or examples in a suitable manner. In addition, those skilled in the art may combine and combine the different embodiments or examples described in this specification and the features of the different embodiments or examples, without contradiction.

[0079] The above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit the same. Although the present invention has been described in detail with reference to the above embodiments, those skilled in the art should understand that the technical solutions described in the above embodiments may still be modified, or some or all of the technical features may be replaced by equivalents. However, these modifications or replacements do not deviate the essence of the corresponding technical solutions from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. A prosthesis delivery device, characterized in that: include: Handle housing; A control wire, the distal end of which is used to connect with the prosthesis; A moving shaft, movably accommodated in the handle housing, and used to drive the prosthesis to change state by driving the control wire to move; The driving handle can be rotated relative to the handle housing to drive the movable shaft to move and transmit the external torque to the prosthesis. The driving handle includes an overload protection component, which is configured to transmit torque below a threshold to the movable shaft and prevent torque above a threshold from being transmitted to the movable shaft.

2. The prosthesis delivery device according to claim 1, characterized in that: The driving handle also includes a transmission member, which is threadably matched with the moving shaft to drive the moving shaft to move, and the overload protection component is sleeved on the outer side of the transmission member.

3. The prosthesis delivery device according to claim 2, characterized in that: The overload protection assembly comprises a support member, a passive member and an active member, wherein the passive member is circumferentially stationary relative to the transmission member and can move axially relative to the transmission member; The active member is axially stationary relative to the transmission member, and can rotate circumferentially relative to the transmission member; The support member is used to keep the passive member and the active member in axial contact; The passive component and the active component respectively include a first abutting surface and a second abutting surface, the first abutting surface and the second abutting surface are arranged correspondingly, the first abutting surface and the second abutting surface are planes at least in the abutting position, and the planes are not parallel to the axis of the driving handle.

4. The prosthesis delivery device according to claim 3, characterized in that: The first abutting surface and the second abutting surface are both planes perpendicular to the axis of the driving handle.

5. The prosthesis delivery device according to claim 3, characterized in that: The first abutting surface includes a first vertical surface, a first horizontal surface and a first inclined surface connected in sequence; the second abutting surface includes a second vertical surface, a second horizontal surface and a second inclined surface connected in sequence; the first vertical surface and the second vertical surface are both planes parallel to the axis of the driving handle, the first horizontal surface and the second horizontal surface are both planes perpendicular to the axis of the driving handle, and the first inclined surface and the second inclined surface are both planes arranged at an angle to the axis of the driving handle, and the angles are the same.

6. The prosthesis delivery device according to claim 3, characterized in that: The first abutting surface includes a first inclined surface and a third inclined surface connected to the first inclined surface; the second abutting surface includes a second inclined surface and a fourth inclined surface connected to the second inclined surface; the first inclined surface and the second inclined surface are both planes arranged at an angle to the axis of the driving handle, and the angles are the same, and the third inclined surface and the fourth inclined surface are both planes arranged at an angle to the axis of the driving handle, and the angles are the same.

7. The prosthesis delivery device according to claim 2, characterized in that: The overload protection assembly comprises a support member, a passive member and an active member, wherein the passive member is circumferentially stationary relative to the transmission member and can move axially relative to the transmission member; The active member is axially stationary relative to the transmission member, and can rotate circumferentially relative to the transmission member; The support member is used to keep the passive member and the active member in axial contact; The passive component and the active component respectively include a first abutting surface and a second abutting surface, the first abutting surface and the second abutting surface are arranged correspondingly, at least one of the first abutting surface and the second abutting surface is a curved surface at the abutting position, and the first abutting surface and the second abutting surface are circumscribed at the abutting position, and the circumscribed surface is not parallel to the axis of the driving handle.

8. The prosthesis delivery device according to claim 3 or 7, characterized in that: The passive component comprises a first body and a first abutting portion, the first body is located at the distal end of the first abutting portion, and the first abutting surface is arranged at the proximal end surface of the first abutting portion; The active member includes a second body and a second abutting portion, the second body is located at the proximal end of the second abutting portion, and the second abutting surface is arranged on the distal end surface of the second abutting portion.

9. The prosthesis delivery device according to claim 8, characterized in that: The diameter of the first abutting portion is greater than the diameter of the first body. A first blocking shoulder is formed at a connection between the first abutting portion and the first body. The first blocking shoulder is used to abut against the support member.

10. The prosthesis delivery device according to claim 9, characterized in that: The overload protection component also includes a accommodating seat, which is fixedly sleeved on the outside of the transmission member, and the support member, the active member and the passive member are coaxially sleeved on the outer surface of the accommodating seat; the accommodating seat includes a distal part, a middle part and a proximal part; the radial dimension of the distal part is larger than the radial dimension of the middle part, forming a distal shoulder, the radial dimension of the middle part is larger than the radial dimension of the proximal part, forming a proximal shoulder, the distal shoulder is used to support the support member, and the proximal shoulder is used to abut the passive member to prevent the passive member from moving too far toward the distal end.

11. The prosthesis delivery device according to claim 10, characterized in that: The supporting member is a spring, one end of the spring abuts against the distal shoulder, and the other end of the spring abuts against the first preventing shoulder.

12. The prosthesis delivery device according to claim 10, characterized in that: A first anti-rotation groove is arranged on the first body of the passive component, and a first anti-rotation pin is arranged on the outer surface of the proximal portion. The first anti-rotation pin is axially movably accommodated in the first anti-rotation groove.

13. The prosthesis delivery device according to claim 10, characterized in that: The overload protection assembly further comprises a transmission housing, which is coaxially sleeved on the outside of the active member to receive external torque and transmit it to the active member, and the active member is configured to remain circumferentially stationary relative to the transmission housing.

14. The prosthesis delivery device according to claim 13, characterized in that: A second anti-rotation groove is arranged on the second body of the active member, and a second anti-rotation pin is arranged on the inner wall of the transmission housing. The second anti-rotation pin is axially movably accommodated in the second anti-rotation groove.

15. The prosthesis delivery device according to claim 10, characterized in that: The overload protection assembly also includes a accommodating cover, the distal end of the accommodating cover has an axially extending coupling portion, the proximal end of the accommodating cover has a circumferentially extending blocking portion, the coupling portion is coupled to the proximal end of the accommodating seat to detachably fix the accommodating cover to the accommodating seat, and the blocking portion is used to keep the active member axially stationary relative to the transmission member.

16. The prosthesis delivery device according to claim 2, characterized in that: The handle shell comprises an inner cavity, the proximal end of the handle shell is provided with an opening, the distal end of the transmission member is provided at the opening, and the transmission member is configured to be only able to rotate relative to the handle shell.

17. The prosthesis delivery device according to claim 16, characterized in that: The transmission member has a limiting protrusion located at the distal end and a limiting ridge located at the proximal end of the limiting protrusion, the limiting protrusion is circumferentially arranged on the transmission member and located inside the handle housing, the limiting ridge is circumferentially arranged on the transmission member and located outside the handle housing, and the limiting protrusion and the limiting ridge form an open groove; The opening is contracted to form an opening shoulder, and the opening shoulder is accommodated in the opening groove.

18. A prosthesis system, characterized in that: The invention comprises a prosthesis delivery device and a prosthesis as described in any one of claims 1 to 17.

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