WO2024067828A1 - 一种假体系统 - Google Patents

一种假体系统 Download PDF

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Publication number
WO2024067828A1
WO2024067828A1 PCT/CN2023/122740 CN2023122740W WO2024067828A1 WO 2024067828 A1 WO2024067828 A1 WO 2024067828A1 CN 2023122740 W CN2023122740 W CN 2023122740W WO 2024067828 A1 WO2024067828 A1 WO 2024067828A1
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WO
WIPO (PCT)
Prior art keywords
section
limiting
coupling portion
groove
channel
Prior art date
Application number
PCT/CN2023/122740
Other languages
English (en)
French (fr)
Inventor
黄镇
潘凤洋
宫振鹏
王奔
Original Assignee
应脉医疗科技(上海)有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from CN202222625620.7U external-priority patent/CN219184341U/zh
Priority claimed from CN202211216019.0A external-priority patent/CN117796964A/zh
Application filed by 应脉医疗科技(上海)有限公司 filed Critical 应脉医疗科技(上海)有限公司
Publication of WO2024067828A1 publication Critical patent/WO2024067828A1/zh

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod

Definitions

  • the embodiments of the present application relate to the field of medical device technology, and in particular to a prosthesis system.
  • Minimally invasive surgery was developed to reduce the harm caused to patients by traditional open-chest surgery.
  • minimally invasive surgery mostly uses a delivery device to deliver the prosthesis to the target location through the natural cavity of the human body, and then indirectly controls the prosthesis by manipulating the control wire of the delivery device to change the state of the prosthesis to achieve the purpose of the surgery.
  • Chinese patent application CN111789699A discloses a mechanical structure that uses a control wire of a delivery device to control a prosthesis, thereby changing the state of the prosthesis and using the prosthesis to achieve the purpose of surgery. Furthermore, in this patent application, when configuring a control wire and a prosthesis, one end of the control wire is extended from the proximal end of the delivery device to the distal end of the delivery device, then passes through a hole on the prosthesis, and then extends to the proximal end of the delivery device. In this way, the control wire is prone to the risk of knotting, jamming, etc.
  • the purpose of the embodiments of the present application is to provide a prosthesis system that can safely and reliably adjust the state of the prosthesis while avoiding knotting and jamming of the control wire as in the prior art, thereby reducing surgical risks.
  • an embodiment of the present application provides a prosthesis system, including: a prosthesis and a conveying device; the prosthesis includes a base and a first movable part, the base has a base body and a first coupling part and a first limiting part arranged on the base body; the conveying device includes a connecting shaft and a first control wire, the connecting shaft has a shaft body and a second coupling part and a second limiting part arranged on the shaft body, the second coupling part is used to be detachably coupled with the first coupling part, the second limiting part is used to form a first limiting channel together with the first limiting part, the first control wire has a first section and a second section connected, the first section is used to independently drive the first movable part to move; the first limiting part and the second limiting part are configured so that when the first coupling part and the second coupling part are coupled, a first limiting channel in a locked state is formed between the first limiting part and the second limiting part, and
  • the prosthesis system provided in the embodiment of the present application can be connected to the connecting shaft through the first coupling part of the base during minimally invasive surgery.
  • the coupling between the first and second coupling parts enables the delivery device to be connected to the prosthesis, and the first limiting channel formed between the first limiting part and the second limiting part is in a locked state, so that the second section of the first control wire is constrained at the first limiting channel by using the first limiting channel in the locked state, so that the first control wire cannot be separated from the first limiting channel, and then the prosthesis can be delivered to the target position in the human body through the delivery device via a surgical path such as a natural cavity of the human body; when the prosthesis needs to be manipulated, the first limiting channel is still in a locked state to constrain the second section of the first control wire at the first limiting channel, so that the part extending from the first section of the first limiting channel can be used to adjust the movement of the first movable part of the prosthesis, so that the state of the prosthesis changes,
  • connection shaft between the prosthesis base and the delivery device can be disassembled to separate the delivery device from the prosthesis, and then the delivery device can be withdrawn from the human body to complete the implantation operation.
  • the first movable part in the prosthesis can be safely and reliably adjusted through the first control wire of the delivery device to achieve a change in the state of the prosthesis.
  • the first control wire and the prosthesis when configuring the first control wire and the prosthesis, it is only necessary to extend the control wire from the proximal end of the delivery device to the distal end of the delivery device and to the first limiting channel, and then the first limiting channel is locked to constrain the second section of the first control wire at the first limiting channel.
  • the first section connected to the second section can be used to control the first movable part of the prosthesis, without having to first extend from the proximal end to the distal end of the delivery device and then extend from the distal end to the proximal end of the delivery device after passing through the prosthesis as in the prior art, thereby avoiding the control wire from being easily knotted or stuck as in the prior art, thereby reducing the risk of surgery.
  • FIG1 is a schematic diagram of coupling the distal end of a delivery device with a mitral valve clip provided in some embodiments of the present application;
  • FIG2 is a schematic structural diagram of a clamping arm of a mitral valve clip coupled to a delivery device provided in some embodiments of the present application when in motion;
  • FIG3 is a schematic structural diagram of the distal end of a delivery device provided in some embodiments of the present application.
  • FIG4 is a schematic diagram of the structure of a first control wire provided in some embodiments of the present application.
  • FIG5 is a schematic diagram of the structure of the distal end of the connecting shaft provided in some embodiments of the present application.
  • FIG6 is a schematic structural diagram of another perspective of the distal end of the connecting shaft provided in some embodiments of the present application.
  • FIG7 is a structural schematic diagram of the distal end of the connecting shaft provided in some embodiments of the present application from another perspective;
  • FIG8 is a schematic structural diagram of a base of a prosthesis provided in some embodiments of the present application.
  • FIG9 is a schematic diagram of the structure of the control wire, the connecting shaft and the base provided in some embodiments of the present application when they cooperate;
  • FIG10 is a schematic diagram of the structure of the control wire, the connecting shaft and the base after they are matched according to some embodiments of the present application;
  • FIG11 is a schematic diagram of the structure of a center rod provided in some embodiments of the present application.
  • FIG12 is a cross-sectional view of a coupling portion cut along the axis of the connecting shaft when the connecting shaft is coupled to the base in a prosthesis system provided by some embodiments of the present application;
  • FIG13 is a cross-sectional view of a connecting shaft and a base provided in some embodiments of the present application cut along the axis of the connecting shaft;
  • FIG14 is a cross-sectional view of a control wire, a first limiting portion, and a second limiting portion cut along the axis of the connecting shaft when the connecting shaft is coupled to the base in a prosthesis system provided by some embodiments of the present application;
  • FIG15 is a schematic cross-sectional view of a first position-limiting channel when a connecting shaft is coupled to a base in a prosthesis system provided by some embodiments of the present application;
  • FIG16 is a schematic structural diagram of a prosthesis system provided by some embodiments of the present application, in the process of coupling a connecting shaft and a base;
  • FIG17 is a schematic diagram of the structure of a prosthesis system provided by some embodiments of the present application after the connecting shaft and the base are separated;
  • FIG18 is a schematic cross-sectional view of a first position-limiting channel when the connecting shaft is coupled to the base in the prosthesis system provided by some embodiments of the present application;
  • FIG19 is a schematic diagram of the structure of a mitral valve clip provided in some embodiments of the present application.
  • FIG20 is a schematic diagram of the structure of the clamping arm and the control wire provided in some embodiments of the present application when they cooperate;
  • FIG21 is a schematic diagram of the structure of another clamping arm and a control wire in cooperation with each other provided in some embodiments of the present application;
  • Figure 22 is a schematic diagram of the structure of another clamping arm and control wire provided in some embodiments of the present application.
  • the terms “upper”, “lower”, “left”, “right”, “front”, “back”, “top”, “bottom”, “inner”, “outer”, “middle”, “vertical”, “horizontal”, “lateral”, “longitudinal” and the like indicate positions or positional relationships based on the positions or positional relationships shown in the drawings. These terms are mainly used to better describe the present application and its embodiments, and are not used to limit the indicated devices, elements or components to have a specific orientation, or to be constructed and operated in a specific orientation.
  • install should be used in a broad sense.
  • it can be a fixed connection, a detachable connection, or an integral structure; it can be a mechanical connection, or an electrical connection; it can be a direct connection, or an indirect connection through an intermediate medium, or it can be an internal connection between two devices, elements, or components.
  • install can be a fixed connection, a detachable connection, or an integral structure; it can be a mechanical connection, or an electrical connection; it can be a direct connection, or an indirect connection through an intermediate medium, or it can be an internal connection between two devices, elements, or components.
  • first means two or more.
  • proximal end and distal side refer to the end closer to the operator and away from the patient; correspondingly, “distal end” and “distal side” refer to the end closer to the patient and away from the operator.
  • parallel and perpendicular should not be narrowly understood as 0° or 90°, but should be understood as a reasonable angle range including 0° or 90° and having a certain floating angle under the premise of achieving technical effects.
  • a prosthesis system including: a prosthesis and a conveying device; the prosthesis includes a base and a first movable part, the base has a base body and a first coupling part and a first limiting part arranged on the base body; the conveying device includes a connecting shaft and a first control wire, the connecting shaft has an axis body and a second coupling part and a second limiting part arranged on the axis body, the second coupling part is used to be detachably coupled with the first coupling part, the second limiting part is used to form a first limiting channel together with the first limiting part, the first control wire has a first section and a second section connected, the first section is used to independently drive the first movable part to move; the first limiting part and the second limiting part are configured such that when the first coupling part and the second coupling part are coupled, a first limiting channel in a locked state is formed between the first limiting part and the second limiting part, and the second
  • the prosthesis system provided in the embodiment of the present application can connect the delivery device to the prosthesis through the coupling between the first coupling portion of the base and the second coupling portion of the connecting shaft during minimally invasive surgery, and make the first limiting channel formed between the first limiting portion and the second limiting portion in a locked state, so that the second section of the first control wire can be constrained at the first limiting channel by using the first limiting channel in the locked state, so that the first control wire cannot be separated from the first limiting channel, and then the prosthesis can be delivered to the target position in the human body through the delivery device via a surgical path such as a natural cavity of the human body; when the prosthesis needs to be manipulated, the first limiting channel is still in a locked state to constrain the second section of the first control wire at the first limiting channel, so that the part extending from the first section out of the first limiting channel can be used to adjust the movement of the first movable part of the prosthesis, so that the state of the prosthesis changes, so as to realize the implantation of
  • the connecting shaft of the prosthesis base and the delivery device can be disassembled to separate the delivery device and the prosthesis, thereby facilitating the delivery device to be removed.
  • the first movable part in the prosthesis can be safely and reliably adjusted through the first control wire of the delivery device to achieve a change in the state of the prosthesis.
  • the first control wire and the prosthesis when configuring the first control wire and the prosthesis, it is only necessary to extend the control wire from the proximal end of the delivery device to the distal end of the delivery device and to the first limiting channel, and then the first limiting channel is locked to constrain the second section of the first control wire at the first limiting channel.
  • the first section connected to the second section can be used to control the first movable part of the prosthesis, without having to first extend from the proximal end to the distal end of the delivery device and then extend from the distal end to the proximal end of the delivery device after passing through the prosthesis as in the prior art, thereby avoiding the control wire from being easily knotted or stuck as in the prior art, thereby reducing the risk of surgery.
  • some embodiments of the present application provide a prosthesis system, including: a prosthesis and a delivery device 100; the prosthesis includes a base 210 and a first movable member, the base 210 having a seat body 211 and a first coupling portion 212 and a first limiting portion 213 disposed on the seat body 211; the delivery device 100 includes a connecting shaft 110 and a first control wire 120, the connecting shaft 110 having a shaft body 111 and a second coupling portion 112 and a second limiting portion 113 disposed on the shaft body 111, the second coupling portion 112 being used for detachably coupling with the first coupling portion 212, the second limiting portion 113 being used for forming a first limiting channel 300 together with the first limiting portion 213, the first control wire 120
  • the wire 120 has a first section 121 and a second section 122 connected to each other, and the first section 121 is used to independently drive the first movable part to move; the first limiting portion
  • the positions of the first coupling portion 212 and the first limiting portion 213 can be made independent of each other to simplify the difficulty of designing and manufacturing the first coupling portion 212 and the first limiting portion 213, and the positions of the second coupling portion 112 and the second limiting portion 113 can be made independent of each other to simplify the difficulty of designing and manufacturing the second coupling portion 112 and the second limiting portion 113. Further, when the first coupling portion 212 and the second coupling portion 112 are coupled, the first limiting portion 213 and the second limiting portion 113 can cooperate with each other to form the first limiting channel 300 in a locked state.
  • the first limiting channel 300 is arranged at an angle to the axis of the connecting shaft 110. Further, the extending direction of the first limiting channel 300 and the axis of the connecting shaft 110 have an angle greater than 0° and less than 180°. In some embodiments, the extending direction of the first limiting channel 300 and the axis of the connecting shaft 110 are perpendicular to each other.
  • the first coupling portion 212 and the first limiting portion 213 are spaced apart along the circumference of the seat body 211 at the proximal end of the seat body 211 ; the second coupling portion 112 and the second limiting portion 113 are correspondingly disposed along the circumference of the shaft body 111 at the distal end of the shaft body 111 .
  • the second coupling portion 112 and the second limiting portion 113 are correspondingly arranged along the circumference of the shaft body 111, which means that the second coupling portion 112 and the second limiting portion 113 are arranged in sequence along the circumference of the shaft body 111, and the second coupling portion 112 is arranged at a position corresponding to the first coupling portion 212 to form a coupling point, thereby realizing the coupling between the base 210 and the connecting shaft 110; and the second limiting portion 113 is arranged at a position corresponding to the first limiting portion 213 to form a first limiting channel 300.
  • the first coupling portion 212 or the second coupling portion 112 is arranged in an axially offset manner relative to the connecting shaft 110 ; when the offset coupling portion is driven to be arranged in the axial direction of the connecting shaft 110 , the first coupling portion 212 and the second coupling portion 112 are coupled.
  • first coupling portion 212 and the second coupling portion 112 are coupled when the offset coupling portion (the first coupling portion 212 or the second coupling portion 112 ) is driven to be arranged along the axial direction of the connecting shaft 110 .
  • one of the first coupling portion 212 and the second coupling portion 112 has a protrusion 101, and the other has a groove 102; wherein, when the first coupling portion 212 or the second coupling portion 112 is offset relative to the axial direction of the connecting shaft 110, the protrusion 101 is separated from the groove 102; when the offset coupling portion is driven to be arranged along the axial direction of the connecting shaft 110, the protrusion 101 is accommodated in the groove 102.
  • the coupling between the first coupling portion 212 and the second coupling portion 112 can be achieved by accommodating the protrusion 101 in the groove 102, thereby achieving the coupling between the connecting shaft 110 and the base 210.
  • the second coupling portion 112 further has a support member 103 biased inwardly, and the protrusion 101 is located at the distal end of the support member 103 and protrudes outwardly perpendicular to the axial direction of the support member 103;
  • the base 210 is provided with a receiving channel 104 for receiving the second coupling portion 112, and the groove 102 is provided on the inner wall surface of the receiving channel 104; when the support member 103 is driven to deflect so that the axis of the support member 103 is arranged axially along the connecting shaft 110, the protrusion 101 is accommodated in the groove 102.
  • the protrusion 101 is accommodated in the groove 102.
  • the second coupling portion 112 further has a support member 103 biased outward, the protrusion 101 is located at the distal end of the support member 103 and protrudes inward perpendicular to the axial direction of the support member 103; the groove 102 is provided on the outer wall surface of the base 210; when the support member 103 is driven to deflect so that the axis of the support member 103 is arranged axially along the connecting shaft 110, the protrusion 101 is accommodated in the groove 102.
  • the protrusion 101 is accommodated in the groove 102.
  • the support member 103 may be provided with a groove 102, and the base 210 may be provided with a protrusion 101 at a position corresponding to the groove 102.
  • the groove 102 on the support member 103 may accommodate the protrusion 101, thereby achieving "when the offset coupling portion is driven to be arranged axially along the shaft body 111, the protrusion 101 is accommodated in the groove 102", thereby achieving the connection between the connecting shaft 110 and the base 210.
  • the support member 103 may also be disposed on the base 210, and the protrusion 101
  • the conveying device 100 further includes: a central rod 130, and the central rod 130 is configured such that when a portion of the central rod 130 is located at the coupling portion of the first coupling portion 212 and the second coupling portion 112, the central rod 130 drives the offset coupling portion to be arranged along the axial direction of the connecting shaft 110.
  • the central rod 130 moves toward the coupling portion of the first coupling portion 212 and the second coupling portion 112 the central rod 130 pushes the offset coupling portion to deflect toward the axial direction of the connecting shaft 110, and when a portion of the central rod 130 is located at the coupling portion of the first coupling portion 212 and the second coupling portion 112, the offset coupling portion is arranged along the axial direction of the connecting shaft 110, thereby facilitating the connection between the connecting shaft 110 and the base 210.
  • the receiving channel 104 arranged along the axial direction of the connecting shaft 110 can also be arranged on the connecting shaft 110 and the base 210 at the same time, and the center rod 130 can be movably arranged in the receiving channel 104; when the center rod 130 is placed at the coupling position of the connecting shaft 110 and the base 210, the offset coupling portion can be driven to be arranged along the axial direction of the connecting shaft 110.
  • the second coupling portion 112 includes the inwardly offset support member 103 mentioned in the above embodiment.
  • the center rod 130 After the center rod 130 is placed in the receiving channel 104, when the center rod 130 moves from the proximal end to the distal end of the connecting shaft 110 and passes through the second coupling portion 112 and the first coupling portion 212, it abuts against the support member 103, so that the support member 103 is driven to deflect outward.
  • the protrusion 101 can be accommodated in the groove 102, thereby realizing the coupling of the connecting shaft 110 and the base 210.
  • the center rod 130 is a hollow rod; when the center rod 130 is sleeved at the coupling of the connecting shaft 110 and the base 210, the offset coupling portion can be driven to be arranged axially along the connecting shaft 110.
  • the second coupling portion 112 includes the above-mentioned outwardly offset support member 103.
  • the center rod 130 moves to the distal end and sleeved at the coupling of the second coupling portion 112 and the first coupling portion 212, the center rod 130 abuts against the support member 103, causing the support member 103 to be driven to deflect inward.
  • the center rod 130 may be provided with an avoidance path extending axially from the distal end to the proximal end of the center rod 130, and the avoidance path is arranged corresponding to the first limiting channel 300 in the circumferential direction of the connecting shaft 110.
  • the avoidance path is used to avoid the first control wire 120 extending from the first limiting channel 300, so as to facilitate the first control wire 120 to control the first movable part.
  • the specific method of forming the first limiting channel 300 between the first limiting portion 213 and the second limiting portion 113 is not limited.
  • one of the first limiting portion 213 and the second limiting portion 113 has a first latch 105, and the other has a first through slot 107, the first through slot 107 is arranged at an angle to the connecting shaft 110, and the first through slot 107 is provided with a first opening 106 on a side wall opposite to the first latch 105, the first latch 105 is used to be inserted into the first through slot 107 through the first opening 106 to occupy the restricted space; when the first coupling portion 212 and the second coupling portion 112 are coupled, the first latch 105 is inserted into the first through slot 107 and occupies the restricted space, and the remaining space defined by the first through slot 107 forms a locking when the first coupling portion 212 and the second coupling portion 112 are separated, the first latch 105 is located outside the first through slot 107, and the space defined by the first through slot 107 forms the first limiting channel 300 in the unlocked state.
  • the radial dimension of the second section 122 of the first control wire 120 is at least greater than the radial dimension of the portion of the first section 121 connected to the second section 122, and the space defined by the first through slot 107 is configured to accommodate the second section 122.
  • the first control wire 120 can move freely in the space defined by the first through slot 107, so that it can be separated from the first limiting channel 300.
  • the first latch 105 occupies part of the space defined by the first through slot 107 (i.e., the restricted space), and the minimum radial dimension of the remaining space is configured to be smaller than the radial dimension of the second section 122, and at least larger than the radial dimension of the first section 121 connected to the second section 122, so that the second section 122 of the first control wire 120 cannot move freely therein and is constrained in the first limiting channel 300.
  • the remaining space defined by the first through slot 107 forms the first limiting channel 300 in a locked state.
  • the first latch 105 is disengaged from the first through slot 107. Since the radial dimensions of each part of the space defined by the first through slot 107 are configured to be equal to or greater than the radial dimensions of the second section 122, so as to accommodate the second section 122. Therefore, the first control wire 120 can move freely in the space defined by the first through slot 107, and can be separated from the first limiting channel 300. At this time, the space defined by the first through slot 107 forms the first limiting channel 300 in an unlocked state.
  • the first limiting passage 300 in the locked state is a restricted space
  • the first limiting passage 300 in the unlocked state is an unrestricted space or a space with a smaller restriction. In this way, by controlling whether the first limiting passage 300 is restricted or the restricted size, the first control wire 120 is constrained or releasable.
  • first through slot 107 is arranged at an angle to the connecting shaft 110, which can be referred to as the first limiting channel 300 and the connecting shaft 110 are arranged at an angle in the above content, and will not be repeated here.
  • the extension direction of the first through slot 107 is perpendicular to the axis of the connecting shaft 110.
  • the radial dimension in this embodiment refers to the dimension of the cross section perpendicular to the extension direction.
  • the radial dimension of the first limiting channel 300 is the cross-sectional dimension of the first limiting channel 300 perpendicular to its extension direction.
  • the radial dimension of the first limiting channel 300 is the diameter of the cross section of the first limiting channel 300.
  • the radial dimension of the first limiting channel 300 is the dimension obtained according to a specific rule, such as: twice the distance from the geometric center of its cross section to a certain point on the cross section.
  • the dimension of the first limiting channel 300 is the diameter of the circumscribed circle of the cross section of the first limiting channel 300. In some embodiments, the dimension of the first limiting channel 300 is the diameter of the inscribed circle of the cross section of the first limiting channel 300. In some embodiments, the dimension of the first limiting channel 300 is twice the minimum distance value from the geometric center of its cross section to all points on the edge of the cross section. In some embodiments, the radial dimension of the first limiting channel 300 is twice the minimum distance value from the geometric center of its cross section to all points on the edge of the cross section. The size of a limiting channel 300 is twice the maximum distance value among the distances from the geometric center of its cross section to all points on the edge of the cross section. Those skilled in the art can select appropriate rules according to needs. The radial dimensions of the first control wire 120 at various locations and even the radial dimensions of other components are also agreed upon in this way, which will not be repeated here.
  • the present embodiment has no particular limitation on the shape of the second segment 122 .
  • the second segment 122 may be linear, spherical, hemispherical, spherical cap, spherical segment, or ellipsoidal.
  • the connecting shaft 110 is provided with a receiving channel 104, or the connecting shaft 110 and the base 210 are both provided with a receiving channel 104; the first through groove 107 partially intersects with the receiving channel 104 to form an overlapping space, and the overlapping space includes the above-mentioned restricted space; when the first coupling portion 212 and the second coupling portion 112 are coupled, the first latch 105 extends into the receiving channel 104 and occupies the restricted space in the overlapping space to form a first limiting channel 300 in a locked state; when the first coupling portion 212 and the second coupling portion 112 are separated, the first latch 105 is located outside the overlapping space to form a first limiting channel 300 in an unlocked state.
  • the accommodating channel 104 includes a second accommodating section 114 disposed on the connecting shaft 110, and a first accommodating section 214 disposed on the base 210.
  • the first latch 105 disposed on the connecting shaft 110 extends into the first accommodating section 214 and occupies the restricted space to form a first limiting channel 300 in a locked state; when the first coupling portion 212 and the second coupling portion 112 are separated, the first latch 105 is located outside the overlapped space to form a first limiting channel 300 in an unlocked state.
  • the first latch 105 disposed on the base 210 extends into the second accommodating section 114 and occupies the restricted space to form a first limiting channel 300 in a locked state; when the first coupling portion 212 and the second coupling portion 112 are separated, the first latch 105 is located outside the overlapped space to form a first limiting channel 300 in an unlocked state.
  • the connecting shaft 110 is provided with the above-mentioned accommodation channel 104.
  • the accommodation channel 104 includes a second accommodation section 114 disposed on the connecting shaft 110.
  • the first through groove 107 includes a first end and a second end, the first end is located on a side of the second section 122 away from the first section 121, and the second end is located on a side of the second section 122 close to the first section 121; the first end is configured to be closed to prevent the second section 122 from escaping; the first section 121 extends out of the first channel through the second end.
  • the present application does not limit the specific implementation of "the first end is configured to be closed".
  • the first end is blocked by a blocking member so that the first end is closed.
  • the first end is not opened so that the first end is closed.
  • the second section 122 can be prevented from jumping out of the first channel from the first end, thereby preventing the second section 122 from getting stuck with other parts or human tissues during surgery, thereby reducing surgical risks.
  • one of the first limiting portion 213 and the second limiting portion 113 has a second latch and the other has a second through groove
  • the second through groove is configured so that the minimum radial dimension of the space defined by the second through groove can only accommodate the first section 121 of the first control wire 120, and the second through groove extends axially in the direction toward the second latch and forms a first notch, and the second latch is used to embed into the second through groove through the first notch; when the first coupling portion 212 and the second coupling portion 112 are coupled, the second latch is embedded in the first notch of the second through groove, and the closed remaining space defined by the second through groove forms a first limiting channel 300 in a locked state; when the first coupling portion 212 and the second coupling portion 112 are separated, the second latch is located outside the second through groove, and the space defined by the second through groove forms the first limiting channel 300 in an unlocked state.
  • the radial dimension of the entire space defined by the second through groove is less than the radial dimension of the second section 122 of the first control wire, and at least greater than the radial dimension of the part of the first section 121 connected to the second section 122.
  • the entire space defined by the second through groove can only accommodate the first section 121 of the first control wire 120, and the second section 122 is located outside.
  • the first control wire 120 cannot be directly withdrawn.
  • the second through groove extends axially in a direction toward the second plug pin and forms a first notch, and the first control wire 120 can be separated from the second through groove from the first notch.
  • the connecting shaft 110 and the base 210 can be fixed to achieve the goal that no relative movement occurs between the connecting shaft 110 and the base 210, and at the same time, the second pin is embedded in the first slot of the second through groove, and the first slot is shielded by the second pin, so that the space defined by the second through groove is closed to form a first limiting channel 300 in a locked state, and the second section 122 is constrained at the first limiting channel 300, and the first control wire 120 cannot be separated from the first slot and the second through groove.
  • the space defined by the second through slot is opened to form the first limiting channel 300 in an unlocked state, and the first control wire 120 can be separated from the first slot and the second through slot.
  • the first limiting passage 300 in the locked state is a closed space
  • the first limiting passage 300 in the unlocked state is an open space. In this way, by controlling whether the first limiting passage 300 is closed, the first control wire 120 is constrained or releasable.
  • one of the first limiting portion 213 and the second limiting portion 113 has a third latch and the other has a third through slot
  • the third through slot is configured such that the space defined by the third through slot can accommodate the first control wire 120
  • the third through slot extends axially in the direction toward the third latch and forms a second notch
  • the third latch is used to be embedded in the second notch.
  • the third through slot is used to occupy the restricted space.
  • the difference from the above-mentioned second latch embodiment is that the embedding of the third latch limits the space formed by the third through slot, and the second section 122 can no longer be accommodated, but part of the first section 121 connected to the second section 122 can be accommodated, so that the second section 122 is constrained in the first limiting channel 300.
  • the third latch When the first coupling part 212 and the second coupling part 112 are coupled, the third latch is embedded in the third through slot through the second notch and occupies the restricted space, and the remaining space defined by the third through slot forms the first limiting channel 300 in a locked state; when the first coupling part 212 and the second coupling part 112 are separated, the third latch is located outside the third through slot, and the space defined by the third through slot forms the first limiting channel 300 in an unlocked state.
  • the similarity with the above-mentioned first latch embodiment is that the radial dimension of the first limiting channel 300 in the unlocked state is greater than the radial dimension of the second segment 122 of the first control wire 120, so as to at least accommodate the second segment 122 of the first control wire 120 and the part of the first segment 121 connected to the second segment 122; the minimum radial dimension of the first limiting channel 300 in the locked state is less than the radial dimension of the second segment 122 of the first control wire 120, and greater than the radial dimension of the first segment 121 of the first control wire 120.
  • the third latch limits the first limiting channel 300 in the axial direction, so that the second segment 122 is constrained in the first limiting channel 300.
  • the first limiting passage 300 in the locked state is a restricted space
  • the first limiting passage 300 in the unlocked state is an unrestricted space. In this way, by controlling whether the first limiting passage 300 is restricted, the first control wire 120 is constrained or releasable.
  • first coupling portion 212 and the first limiting portion 213 are arranged at the proximal end of the seat body 211 along the circumferential direction of the seat body 211 ; the second limiting portion 113 is arranged at the distal end of the shaft body 111 , and the second coupling portion 112 is arranged on the second limiting portion 113 .
  • one of the first coupling portion 212 and the second coupling portion 112 has a protrusion 108, and the other has a bidirectional groove 109 with an open end.
  • the extending direction of the bidirectional groove 109 is to extend in both the circumferential direction and the axial direction at the same time, or the extending direction of the bidirectional groove 109 is to extend in the axial direction first and then in the circumferential direction; the radial dimension of the protrusion 108 matches the radial dimension of the bidirectional groove 109, so that the protrusion 108 can be accommodated in the bidirectional groove 109.
  • the protrusion 108 enters the bidirectional groove 109 from the open end of the bidirectional groove 109 and moves to the other end of the bidirectional groove 109 to achieve the coupling between the first coupling portion 212 and the second coupling portion 112.
  • the protrusion 108 moves from the other end of the bidirectional groove 109 to the open end of the bidirectional groove 109 to the open end of the bidirectional groove 109 to separate from the bidirectional groove 109, so as to achieve the separation of the first coupling portion 212 from the second coupling portion 112.
  • the protrusion 108 is disposed at the distal end of the shaft body 111
  • the bidirectional groove 109 is disposed at the proximal end of the seat body 211.
  • the bidirectional groove 109 includes a first extension portion A and a second extension portion B.
  • the first extension portion A extends axially from the open end to the distal end
  • the second extension portion B extends circumferentially from the other end of the first extension portion A.
  • the first extension portion A and the second extension portion B form a shape similar to an "L".
  • the protrusion 108 enters the first extension portion A from the open end of the bidirectional groove 109, moves axially toward the distal end, enters the second extension portion B, and then moves in the second extension portion B to the other end of the bidirectional groove 109, thereby realizing the coupling of the first coupling portion 212 with the second coupling portion 112.
  • the second coupling portion 112 is coupled.
  • the protrusion 108 moves in the opposite direction from the other end of the bidirectional groove 109 in the second extension portion B, enters the first extension portion A, and then moves from the first extension portion A to the open end of the bidirectional groove 109 to the open end of the bidirectional groove 109 to separate from the bidirectional groove 109, so as to separate the first coupling portion 212 from the second coupling portion 112.
  • the inner wall of the seat body 211 is provided with a first shallow groove extending axially (not shown in the figure), and the outer wall of the shaft body 111 is provided with a second shallow groove extending axially (not shown in the figure).
  • the first shallow groove and the second shallow groove cooperate to form a limiting channel, which is used to accommodate the limiting wire to further prevent the circumferential relative rotation between the connecting shaft 110 and the base 210. In this way, the coupling between the first coupling portion 212 and the second coupling portion 112 is more reliable.
  • the cooperation mode of the first limiting portion 213 and the second limiting portion 113 can refer to the above-mentioned embodiment.
  • the second limiting portion 113 can be set at the distal end of the shaft body 111; the second coupling portion 112 can be set at the distal end of the shaft body 111, or can be set on the second limiting portion 113, so as to facilitate the setting of the first limiting portion 213.
  • the second limiting portion 113 is a cylindrical pin. In this way, no matter how the first coupling portion 212 rotates with the second coupling portion 112, it can be ensured that the first limiting channel in the locked state will not be converted to the unlocked state.
  • the second position-limiting portion 113 is a cylindrical first latch 105
  • the first latch 105 when the protrusion 108 enters the bidirectional groove 109, the first latch 105 is inserted into the first through groove 107 through the first opening to occupy the restricted space, so that the space defined by the first through groove 107 forms the first position-limiting channel 300 in the locked state; when the protrusion 108 is located outside the bidirectional groove 109, the first latch 105 is located outside the first through groove 107, so that the space defined by the first through groove 107 forms the first position-limiting channel 300 in the unlocked state.
  • the cross-sectional shape of the corresponding second through groove and the third through groove is also circular, and a channel opening is provided along the tangent direction to facilitate the entry of the first control wire 120.
  • a third limiting portion 215 may also be provided, and the first latch 105 and the third limiting portion 215 cooperate with each other to form a second limiting channel 400 for cooperating with the second control wire 140, wherein the cooperation mode of the first latch 105 and the third limiting portion 215 to form the second limiting channel 400 can refer to the cooperation mode of the first latch 105 and the first limiting portion 213 to form the first limiting channel 300, which will not be repeated here.
  • one first latch 105 can be used to cooperate with two limiting portions (i.e., the first limiting portion 213 and the third limiting portion 215).
  • the first control wire 120 further includes a third section, and the third section and the first section 121 are respectively located on both sides of the second section 122.
  • the first section 121 and the third section constrain the second section 122 in the first limiting channel 300; when the first coupling portion 212 and the second coupling portion 112 are separated, the first limiting channel 300 is In the unlocked state, the first control wire 120 can be separated from the first limiting channel 300 .
  • the radial dimension of the first section 121 and the third section of the first control wire 120 at least where they are connected to the second section 122 is greater than the radial dimension of the second section 122, and one of the first limiting portion 213 and the second limiting portion 113 has the above-mentioned first latch 105, and the other has the above-mentioned first through groove 107.
  • the radial dimension of the space defined by the first through groove 107 is configured to be greater than the radial dimension of the third section and the first section 121.
  • the minimum radial dimension of the first limiting channel 300 in a locked state is configured to be smaller than the radial dimension of the third section at least where it is connected to the second section 122, smaller than the radial dimension of the first section 121 at least where it is connected to the second section 122, and greater than the radial dimension of the second section 122. In this way, when the first limiting channel 300 is locked, the first section 121 and the third section can constrain the second section 122 in the first limiting channel 300 .
  • the radial dimension of the first section 121 and the third section of the first control wire 120 at least connected to the second section 122 is greater than the radial dimension of the second section 122, and one of the first limiting portion 213 and the second limiting portion 113 has a second latch and the other has a second through groove.
  • the radial dimension of the second through groove is configured to be smaller than the radial dimension of the first section 121 and the third section, and larger than the radial dimension of the second section 122. In this way, the second section 122 is constrained and cannot be withdrawn from the axial direction of the first control wire 120, and can only be separated from the first notch.
  • the first notch When the first limiting channel 300 is in an unlocked state, the first notch is open, and the second section 122 can be withdrawn from the first notch of the second through groove, so that the first control wire 120 is separated from the prosthesis.
  • the first notch When the first limiting channel 300 is in a locked state, the first notch is shielded by the second latch, and the second section 122 cannot be withdrawn from the first notch, and can only be constrained in the first limiting channel 300.
  • the prosthesis further comprises a second movable member, and the third section is used to independently drive the second movable member to move.
  • the third section is used to independently drive the second movable member to move.
  • the base 210 also has a third limiting portion 215 disposed on the base body 211;
  • the connecting shaft 110 also has a fourth limiting portion 115 disposed on the shaft body 111, and the fourth limiting portion 115 is used to form a second limiting channel 400 together with the third limiting portion 215;
  • the prosthesis also includes a second movable member;
  • the conveying device 100 also includes a second control wire 140, and the second control wire 140 has a fourth section and a fifth section connected in sequence, and the fifth section is used to independently drive the second movable member to move;
  • the positioning portion 215 and the fourth positioning portion 115 are configured such that, when the first coupling portion 212 and the second coupling portion 112 are coupled, a second positioning channel 400 in a locked state is formed between the third positioning portion 215 and the fourth positioning portion 115, and the fourth section is constrained at the second positioning channel 400; when the first coupling portion 212 and the second coupling portion 112 are
  • the configuration relationship between the second control wire 140 in this embodiment and the second limiting channel 400 formed by the third limiting portion 215 and the fourth limiting portion 115 can refer to the configuration relationship between the first control wire 120 in the above embodiment and the first limiting channel 300 formed by the first limiting portion 213 and the second limiting portion 113, and will not be repeated here.
  • the configuration relationship between the "third limiting portion 215 and the fourth limiting portion 115" and the “first coupling portion 212 and the second coupling portion 112" in this embodiment can refer to the configuration relationship between the "first limiting portion 213 and the second limiting portion 113" and the “first coupling portion 212 and the second coupling portion 112" in the above-mentioned embodiment, which will not be repeated here.
  • the first limiting portion 213 and the third limiting portion 215 are relatively arranged on both sides of the axis of the seat body 211, and the positional relationship between the second limiting portion 113 and the fourth limiting portion 115 is arranged accordingly according to the positional relationship between the first limiting portion 213 and the third limiting portion 215. In this way, it is convenient to form the first limiting portion 213 and the third limiting portion 215 on the seat body 21, and to form the second limiting portion 113 and the fourth limiting portion 115 on the shaft body 111, and it is convenient to arrange the coupling portion.
  • first limiting channel 300 formed by the first limiting portion 213 and the second limiting portion 113" and the "second limiting channel 400 formed by the third limiting portion 215 and the fourth limiting portion 115" can be arranged relatively to each other. Then, when the first limiting channel 300 constrains the second section 122, and the second limiting channel 400 constrains the fourth section, and when the first section 121 of the first control wire 120 and the fifth section of the second control wire 140 are manipulated, the force on the delivery device 100 and even the prosthesis can be made more uniform.
  • the first coupling portion 212 includes a plurality of first coupling members (such as the protrusions or grooves in the above embodiment), which are evenly arranged in the circumferential direction;
  • the second coupling portion 112 includes a plurality of second coupling members (such as the grooves or protrusions in the above embodiment), and the arrangement of the second coupling members corresponds to the arrangement of the first coupling members;
  • the first coupling member is used to be detachably coupled to the second coupling member arranged correspondingly thereto.
  • the present application does not limit the number and the location of the first coupling members.
  • first coupling members there are two first coupling members, and they are arranged symmetrically.
  • the first limit portion 213 is located between the two first coupling members, and the third limit portion 215 is arranged symmetrically therewith.
  • the first limit portion 213 is located at the angular bisector of the two first coupling members, that is, the line between the first coupling members is perpendicular to the line between the first limit portion 213 and the third limit portion 215.
  • the present embodiment has no particular limitation on the number of movable parts in the prosthesis.
  • the prosthesis may include only one movable part, namely, the first movable part mentioned above. By controlling the movement of the first movable part through the first section 121, the change of the prosthesis state can be achieved.
  • the prosthesis may also include two movable parts, namely, the first movable part and the second movable part mentioned above, and the first movable part is controlled to move by the first section 121, and the second movable part is controlled to move by the third section or the fifth section to achieve the change of the prosthesis state.
  • the prosthesis may also include more than two movable parts, and the control wire is used to control the movement of one or more of the movable parts to achieve the change of the prosthesis state.
  • the above-mentioned “change in state” may be a change in the structure, size, or shape of the entire or part of the prosthesis, such as
  • the "change of state” can be the realization of an unlocked state, a locked state, and/or mutual conversion between a locked state and an unlocked state between the prosthesis and the target tissue, between the prosthesis and the delivery system, and between the internal components of the prosthesis; the "change of state” can also be a change in the position and/or posture of the prosthesis as a whole or in part (for example, the first movable part).
  • the prosthesis includes a movable part.
  • the prosthesis can be a stent graft for treating aortic stenosis.
  • a binding wire i.e., the first movable part
  • the binding wire is released by the control wire to realize the stent graft from the compressed state to the expanded state.
  • the control wire and the left atrial appendage occluder are in a locked state. After the left atrial appendage occluder is released, the control wire is driven to separate from the left atrial appendage occluder, so that the left atrial appendage occluder is in an unlocked state.
  • a prosthesis includes two movable parts.
  • the prosthesis can be a valve clip.
  • the valve clip clamps the edge of the valve leaflet through the movement of the clamping arm and the clamping seat to treat valve regurgitation.
  • the movement of the clamping arm is controlled by the control wire to change the posture of the clamping arm.
  • a prosthesis is taken as an example of a valve clip, i.e., a mitral valve clip 200, for treating mitral valve regurgitation, for further explanation.
  • the prosthesis here is the mitral valve clip 200 for illustration only.
  • the prosthesis may also be a valve clip such as a tricuspid valve clip for treating other valve regurgitation.
  • the prosthesis is used as an interventional or implanted medical device for the treatment or diagnosis of other diseases. The present application does not limit the specific type of the prosthesis.
  • the mitral valve clip 200 includes a base 210, a clamping arm (i.e., a movable part) and a clamping seat, and the clamping arm and the clamping seat can rotate relative to the axis of the base 210.
  • the clamping arm is located at the proximal end of the base 210, and the clamping seat is located at the distal end of the base 210.
  • the clamping arm includes a first clamping arm 220 (i.e., a first movable member) and a second clamping arm 230 (i.e., a second movable member), which are symmetrically arranged about the axis of the base 210.
  • Each clamping arm includes a free end and a connecting end, and the clamping arm can rotate relative to the base 210, so that the free end can be close to or away from the base.
  • first movable part here is the first clamping arm 220
  • second movable part is the second clamping arm 230
  • the first movable part may not be the first clamping arm 220
  • the second movable part may not be the second clamping arm 230.
  • the present application does not limit the specific types of the first movable part and the second movable part.
  • the clamping seat includes a first clamping seat 240 and a second clamping seat 250, which are symmetrically arranged about the axis of the base 210 and are located on the plane where the first clamping arm 220 and the second clamping arm 230 are located, so as to better clamp the edges of the anterior and posterior leaflets of the mitral valve 500.
  • the first clamping seat 240 and the first clamping arm 220 form a first clamping area
  • the second clamping seat 250 and the second clamping arm 230 form a second clamping area.
  • the plane where the first clamping arm 220 and the second clamping arm 230 are located refers to the plane formed by the axis of the first clamping arm 220 and the axis of the second clamping arm 230; "the first clamping seat 240 and The second clamping seat 250 is located on the plane where the first clamping arm 220 and the second clamping arm 230 are located. It means that the axes of the first clamping seat 240 and the second clamping seat 250 are both located on the plane where the first clamping arm 220 and the second clamping arm 230 are located.
  • the first clamping area and the second clamping area are expanded by driving the rotation of the clamping arm and the clamping seat so that the edges of the anterior and posterior leaflets of the mitral valve fall into the clamping area, and then the clamping area is gradually reduced so that the anterior and posterior leaflets of the mitral valve 500 are clamped between the clamping arm and the clamping seat, thereby achieving the treatment of mitral valve regurgitation.
  • the first clamping arm 220 and the second clamping arm 230 are both sheet-shaped, and the connecting end of the first clamping arm 220 and the connecting end of the second clamping arm 230 are elastically connected through a transition portion 221. Further, the transition portion 221 is arranged at the distal end of the base 210. In some embodiments, the first clamping arm 220, the transition portion 221 and the second clamping arm 230 are integrally formed to form a shape similar to an inverted ⁇ . And the first clamping arm 220 and the second clamping arm 230 are in an extended state in a natural state.
  • the first clamping arm 220 When the first section 121 is pulled, the first clamping arm 220 is driven to rotate upward and close to the base 210, and the first clamping arm 220 is elastically deformed. When the first section 121 is no longer pulled and pushed, the first clamping arm 220 rotates away from the base 210 under the action of its own elastic force and returns to its original state.
  • the third section/fifth section when the third section/fifth section is pulled, the second clamping arm 230 is driven to rotate upward and move closer to the base 210, and the second clamping arm 230 is elastically deformed. When the third section/fifth section is no longer pulled, the second clamping arm 230 rotates away from the base 210 and returns to its original state.
  • the first clamping seat 240 and the second clamping seat 250 are both rotatably connected to the base 210.
  • the first clamping seat 240 and the second clamping seat 250 are rotatably connected to the base 210 via the same rotating shaft.
  • the cross-sectional shape of the first clamping seat 240 perpendicular to the axial direction is U-shaped to better wrap the first leaflet edge 510 and the first clamping arm 220 of the mitral valve 500.
  • the cross-sectional shape of the second clamping seat 250 perpendicular to the axial direction is U-shaped to better wrap the second leaflet edge 520 and the second clamping arm 230 of the mitral valve 500.
  • the first clamping seat 240 and the second clamping seat 250 are driven to rotate, and respectively squeeze the leaflet edges of the anterior and posterior leaflets of the mitral valve 500 together with the first clamping arm 220 and the second clamping arm 230, thereby achieving the clamping of the leaflets of the mitral valve 500 by the mitral valve clamp 200.
  • This embodiment has no particular restrictions on the way in which the first section 121 controls the movement of the first movable part and the third section/fifth section controls the movement of the second movable part.
  • the first section 121 is movably connected to the first clamping arm 220.
  • the first clamping arm 220 can rotate with the movement of the first section 121; on the other hand, when the conveying device 100 needs to be separated from the mitral valve clip 200, the first control wire 120 can be separated from the first clamping arm 220.
  • the relationship between the third section/fifth section and the second movable part i.e., the third section/fifth section and the second clamping arm 230) is the same and will not be repeated.
  • the first section 121 extends from the first limiting channel 300 to the distal end, and after extending to the position where the first clamping arm 220 is located, extends in the reverse direction toward the proximal end of the delivery device 100 . Therefore, the first section 121 forms a bent portion at the position where the first clamping arm 220 is located, and the bent portion interpenetrates with the first clamping arm 220 or an accessory disposed on the first clamping arm 220 to facilitate controlling the rotation of the first clamping arm 220 .
  • the second section 122 is configured to be detachable from the first clamping arm 220. In this way, when the first control wire 120 needs to be pulled away from the first clamping arm 220, it can be ensured that the second section 122 can be pulled away from the first clamping arm 220.
  • the accessory is a fixing wire 222 , which is arranged on the first clamping arm 220 by bundling, knotting, etc., and forms a fixing wire body 223 for interpenetrating with the curved portion of the first section 121 .
  • the fixing wire body 223 is annular to form a first through hole for interpenetrating with the above-mentioned curved portion
  • the fixing wire 222 also has a fixing knot 224 connected to the fixing wire body 223, and the fixing knot 224 is arranged on the first clamping arm 220.
  • the curved portion of the first section 121 passes through the first through hole to interpenetrate with the fixing wire body 223.
  • the first clamping arm 220 is provided with a second through hole 225 on its surface, the fixing wire body 223 passes through the second through hole 225 from the side of the first clamping arm 220 away from the base 210, and the fixing knot 224 is arranged on the side of the first clamping arm 220 away from the base 210, and the fixing knot 224 is configured to be unable to pass through the second through hole 225.
  • the fixing knot 224 of the fixing wire 222 is wrapped around the second through hole 225 to be fixedly connected with the first clamping arm 220 .
  • two third through holes 226 are provided on the first clamping arm 220, and one end of the first section 121 away from the second section 122 passes through one third through hole 226 from the side of the first clamping arm 220 away from the first clamping seat 240, that is, the side away from the first clamping area, and then passes through another third through hole 226 from the side of the first clamping arm 220 close to the first clamping seat 240, that is, the side facing the first clamping area, and then extends in the opposite direction toward the proximal end of the conveying device 100.
  • the curved portion of the first section 121 can be formed, that is, the curved portion of the first section 121 can be made to interpenetrate with the first clamping arm 220.
  • the first clamping arm 220 is provided with an even number of third through holes 226 greater than two, and one end of the first section 121 away from the second section 122 alternately passes through the third through holes 226 and then extends in the opposite direction toward the proximal end of the delivery device 100.
  • a curved portion of the first section 121 can also be formed, and the curved portion interpenetrates with the first clamping arm 220.
  • a protrusion 227 is provided on the first clamping arm 220, and a fourth through hole 228 is provided on the protrusion 227 on the first clamping arm 220, and an end of the first section 121 away from the second section 122 passes through the fourth through hole 228.
  • a curved portion of the first section 121 can also be formed, and the curved portion interpenetrates with the first clamping arm 220.
  • the extension direction of the fourth through hole 228 is the same as the extension direction of the first clamping arm 220.
  • connection method between the third section/fifth section and the second clamping arm 230 can refer to the connection method between the first section 121 and the first clamping arm 220 mentioned above, which will not be repeated here.
  • the fourth section can also be configured to be detachable from the second clamping arm 230. When the fourth section is pulled away from the second clamping arm 230 , it is ensured that the fourth section can be pulled away from the second clamping arm 230 .
  • the mitral valve clip 200 further includes: an actuating assembly, which is used to control the rotation of the first clamping seat 240 and the second clamping seat 250 .
  • the actuating assembly includes a first connecting rod 261, a second connecting rod 262 and a slider 263.
  • the proximal end of the first connecting rod 261 is rotatably connected to the first clamping seat 240, and the distal end is rotatably connected to the slider 263, and the slider 263 can move axially relative to the base 210.
  • the first connecting rod 261, the first clamping seat 240, the base 210 and the slider 263 form a motion mechanism similar to a crank slider mechanism.
  • the first clamping seat 240 is driven to rotate.
  • the proximal end of the second connecting rod 262 is rotatably connected to the second clamping seat 250, and the distal end is rotatably connected to the slider 263.
  • the second connecting rod 262, the second clamping seat 250, the base 210 and the slider 263 also form a motion mechanism similar to the above-mentioned crank slider mechanism. When the slider 263 is driven to approach or move away from the base 210, the second clamping seat 250 is driven to rotate.
  • the slider 263 is in a "T" shape, that is, the slider 263 includes a horizontal part and a vertical part.
  • the first base 210 is a hollow structure, and the vertical part of the slider 263 is movably accommodated in the first base 210.
  • the two ends of the horizontal part of the slider 263 are respectively rotatably connected to the first connecting rod 261 and the second connecting rod 262, and the vertical part of the slider 263 is detachably connected to the center rod 130, such as a threaded connection. In this way, the slider 263 can be driven by the center rod 130 to move relatively, so that the first clamping seat 240 and the second clamping seat 250 rotate.
  • the first connecting rod 261 and the second connecting rod 262 are symmetrically arranged about the axis of the base 210. In this way, when the slider 263 drives the first clamping seat 240 and the second clamping seat 250 to move, the rotation angle of the first clamping seat 240 is the same as the rotation angle of the second clamping seat 250.
  • the conveying device 100 also includes: a catheter 150 sleeved on the connecting shaft 110, the catheter 150 is provided with two channels extending axially along the catheter 150; the end of the first section 121 away from the second section 122 passes through the channel from the distal end of one channel and extends to the proximal end of the channel; the end of the third section away from the second section 122 passes through the channel from the distal end of the other channel and extends to the proximal end of the channel, or the end of the fifth section away from the fourth section passes through the channel from the distal end of the other channel and extends to the proximal end of the channel.
  • the first limiting channel 300 and the second limiting channel 400 are adjusted to the unlocked state, and the operator pulls the end of the first section 121 away from the second section 122 at the proximal end of the catheter 150, and pulls the end of the third section or the fifth section away from the fourth section, thereby separating the first control wire 120 and the second control wire 140 from the mitral valve clip 200.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Cardiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Transplantation (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

一种假体系统，假体包括基座(210)和第一活动件，基座(210)具有座体(211)、第一耦合部(212)和第一限位部(213)；输送装置(100)包括连接轴(110)和具有第一段(121)和第二段(122)的第一控制丝(120)，连接轴(110)具有轴体(111)、第二耦合部(112)和第二限位部(113)；第一耦合部(212)和第二耦合部(112)耦合时，第一限位部(213)与第二限位部(113)之间形成呈锁定状态的第一限位通道(300)，第二段(122)被约束在第一限位通道(300)处；第一耦合部(212)和第二耦合部(112)分离后，第一限位部(213)与第二限位部(113)之间形成呈解锁状态的第一限位通道(300)，第一控制丝(120)可与第一限位通道(300)分离。假体系统，在能够安全可靠地调整假体的状态的情况下，可避免控制丝(120)如在先技术般易出现打结、卡塞以降低手术风险。

Description

一种假体系统
相关申请的交叉引用
本申请基于申请号为“202222625620.7”的申请日为2022年09月30日的中国专利申请以及申请号为“202211216019.0”的申请日为2022年09月30日的中国专利申请提出，并要求这些中国专利申请的优先权，这些中国专利申请的全部内容在此以引入方式并入本申请。
技术领域
本申请实施例涉及医疗器械技术领域，特别涉及一种假体系统。
背景技术
为了降低传统的开胸外科手术对患者造成的伤害，微创手术应用而生。目前，微创手术多是利用输送装置将假体经由人体自然腔道等路径输送至目标位置后，通过操控输送装置的控制丝来间接操控假体，而使假体的状态发生变化以利用假体实现手术目的。
中国专利申请CN111789699A公开了一种利用输送装置的控制丝操控假体，而使得假体的状态发生变化以利用假体实现手术目的的机械结构。进一步，在该专利申请中，在配置一根控制丝与假体时，是将该控制丝的一端自输送装置近端延伸至输送装置远端，再穿过假体上的孔，然后延伸至输送装置近端。如此，会致使该控制丝易出现打结、卡塞等风险。
发明内容
本申请实施例的目的在于提供一种假体系统，在能够安全可靠地调整假体的状态的情况下，避免控制丝如在先技术般易出现打结、卡塞以降低手术风险。
为解决上述问题，本申请实施例提供一种假体系统，包括：假体和输送装置；假体包括基座和第一活动件，基座具有座体以及设置于座体的第一耦合部和第一限位部；输送装置包括连接轴和第一控制丝，连接轴具有轴体以及设置于轴体的第二耦合部和第二限位部，第二耦合部用于与第一耦合部可拆卸地耦合，第二限位部用于与第一限位部共同形成第一限位通道，第一控制丝具有相连的第一段和第二段，第一段用于独立地驱动第一活动件运动；第一限位部和第二限位部被配置为，当第一耦合部和第二耦合部耦合时，第一限位部与第二限位部之间形成呈锁定状态的第一限位通道，第二段被约束在第一限位通道处；当第一耦合部和第二耦合部分离后，第一限位部与第二限位部之间形成呈解锁状态的第一限位通道，第一控制丝可与第一限位通道分离。
本申请实施例提供的假体系统，在实施微创手术时，可通过基座的第一耦合部与连接轴 的第二耦合部之间的耦合使得输送装置与假体连接，并使得第一限位部与第二限位部之间形成的第一限位通道呈锁定状态，以利用锁定状态的第一限位通道将第一控制丝的第二段约束在第一限位通道处，使得第一控制丝无法与第一限位通道分离，继而可通过输送装置经由人体自然腔道等手术路径将假体输送至人体内的目标位置；当需操控假体时，第一限位通道仍处于锁定状态以将第一控制丝的第二段约束于第一限位通道处，从而可利用从第一段延伸出第一限位通道的部分来调整假体的第一活动件运动，而使得假体的状态发生变化，以实现假体的植入，进而达到治疗、诊断的目的；当假体植入后，需要将输送装置与假体分离，可使得第一耦合部和第二耦合部分离，第一限位通道呈解锁状态，第二段不再受到第一限位通道的约束，从而第一控制丝可与第一限位通道分离，以使第一控制丝与假体分离。进一步，还可使假体的基座与输送装置的连接轴拆卸，以将输送装置和假体分离，继而便于将输送装置从人体中撤回，以完成植入手术。如此，在实施微创手术的过程中，需操控假体时，可通过输送装置的第一控制丝安全可靠地调整假体中的第一活动件，实现假体状态的改变。
在本申请实施例中，在配置第一控制丝与假体时，仅需将控制丝自输送装置近端延伸至输送装置远端并伸至第一限位通道处，再使得第一限位通道处于锁定状态将第一控制丝的第二段约束在第一限位通道处，即可利用与第二段相连的第一段来操控假体的第一活动件，而无需如在先技术般需先从输送装置近端延伸至远端且在穿过假体后再从输送装置远端延伸至输送装置近端，从而避免控制丝如在先技术般易出现打结、卡塞以降低手术风险。
附图说明
一个或多个实施例通过与之对应的附图中的图片进行示例性说明，这些示例性说明并不构成对实施例的限定，附图中具有相同参考数字标号的元件表示为类似的元件，除非有特别申明，附图中的图不构成比例限制。
图1为本申请一些实施例提供的输送装置远端与二尖瓣夹子耦合的示意图；
图2为本申请一些实施例提供的与输送装置耦合的二尖瓣夹子的夹合臂活动时的结构示意图；
图3为本申请一些实施例提供的输送装置远端的结构示意图；
图4为本申请一些实施例提供的第一控制丝的结构示意图；
图5为本申请一些实施例提供的连接轴远端的结构示意图；
图6为本申请一些实施例提供的连接轴远端的另一视角的结构示意图；
图7为本申请一些实施例提供的连接轴远端的又一视角的结构示意图；
图8为本申请一些实施例提供的假体的基座的结构示意图；
图9为本申请一些实施例提供的控制丝、连接轴与基座配合时的结构示意图；
图10为本申请一些实施例提供的控制丝、连接轴与基座配合后的结构示意图；
图11为本申请一些实施例提供的中心杆的结构示意图；
图12为本申请一些实施例提供的假体系统中，连接轴与基座耦合时耦合处沿连接轴轴线剖切的剖视图；
图13为本申请一些实施例提供的连接轴与基座沿连接轴轴线剖切的剖视图；
图14为本申请一些实施例提供的假体系统中，连接轴与基座耦合时，控制丝、第一限位部与第二限位部沿连接轴轴线剖切的剖视图；
图15为本申请一些实施例提供的假体系统中，连接轴与基座耦合时，位于第一限位通道处的横截面示意图；
图16为本申请一些实施例提供的假体系统中，连接轴与基座耦合过程中的结构示意图；
图17为本申请一些实施例提供的假体系统中，连接轴与基座分离后的结构示意图；
图18为本申请一些实施例提供的假体系统中，连接轴与基座耦合时，位于第一限位通道处的横截面示意图；
图19为本申请一些实施例提供的二尖瓣夹子的结构示意图；
图20为本申请一些实施例提供的夹合臂与控制丝配合时的结构示意图；
图21为本申请一些实施例提供的又一种夹合臂与控制丝配合时的结构示意图；
图22为本申请一些实施例提供的再一种夹合臂与控制丝配合时的结构示意图。
具体实施方式
为使本申请实施例的目的、技术方案和优点更加清楚，下面将结合附图对本申请的各实施例进行详细的阐述。然而，本领域的普通技术人员可以理解，在本申请各实施例中，为了使读者更好地理解本申请而提出了许多技术细节。但是，即使没有这些技术细节和基于以下各实施例的种种变化和修改，也可以实现本申请所要求保护的技术方案。
在本申请实施例中，术语“上”、“下”、“左”、“右”、“前”、“后”、“顶”、“底”、“内”、“外”、“中”、“竖直”、“水平”、“横向”、“纵向”等指示方位或位置关系为基于附图所示的方位或位置关系。这些术语主要是为了更好地描述本申请及其实施例，并非用于限定所指示的装置、元件或组成部分必须具有特定方位，或以特定方位进行构造和操作。
并且，上述部分术语除了可以用于表示方位或位置关系以外，还可能用于表示其他含义，例如术语“上”在某些情况下也可能用于表示某种依附关系或连接关系。对于本领域普通技术人员而言，可以根据具体情况理解这些术语在本申请中的具体含义。
此外，术语“安装”、“设置”、“设有”、“开设”、“连接”、“相连”应做广义 理解。例如，可以是固定连接，可拆卸连接，或整体式构造；可以是机械连接，或电连接；可以是直接相连，或者是通过中间媒介间接相连，又或者是两个装置、元件或组成部分之间内部的连通。对于本领域普通技术人员而言，可以根据具体情况理解上述术语在本申请中的具体含义。
此外，术语“第一”、“第二”等主要是用于区分不同的装置、元件或组成部分(具体的种类和构造可能相同也可能不同)，并非用于表明或暗示所指示装置、元件或组成部分的相对重要性和数量。除非另有说明，“多个”的含义为两个或两个以上。
在本申请各实施例中，“近端”，“近侧”是指更加靠近操作者，远离患者的一端；相应的，“远端”，“远侧”是指更加靠近患者，远离操作者的一端。在本申请各实施例中，“平行”，“垂直”不应狭隘的理解为0°或者90°，而应理解为在实现技术效果前提下包括与0°或者90°并具有一定浮动的合理角度范围。
本申请一些实施例提供一种假体系统，包括：假体和输送装置；假体包括基座和第一活动件，基座具有座体以及设置于座体的第一耦合部和第一限位部；输送装置包括连接轴和第一控制丝，连接轴具有轴体以及设置于轴体的第二耦合部和第二限位部，第二耦合部用于与第一耦合部可拆卸地耦合，第二限位部用于与第一限位部共同形成第一限位通道，第一控制丝具有相连的第一段和第二段，第一段用于独立地驱动第一活动件运动；第一限位部和第二限位部被配置为，当第一耦合部和第二耦合部耦合时，第一限位部与第二限位部之间形成呈锁定状态的第一限位通道，第二段被约束在第一限位通道处；当第一耦合部和第二耦合部分离后，第一限位部与第二限位部之间形成呈解锁状态的第一限位通道，第一控制丝可与第一限位通道分离。
本申请实施例提供的假体系统，在实施微创手术时，可通过基座的第一耦合部与连接轴的第二耦合部之间的耦合使得输送装置与假体连接，并使得第一限位部与第二限位部之间形成的第一限位通道呈锁定状态，以利用锁定状态的第一限位通道将第一控制丝的第二段约束在第一限位通道处，使得第一控制丝无法与第一限位通道分离，继而可通过输送装置经由人体自然腔道等手术路径将假体输送至人体内的目标位置；当需操控假体时，第一限位通道仍处于锁定状态以将第一控制丝的第二段约束于第一限位通道处，从而可利用从第一段延伸出第一限位通道的部分来调整假体的第一活动件运动，而使得假体的状态发生变化，以实现假体的植入，进而达到治疗、诊断的目的；当假体植入后，需要将输送装置与假体分离，可使得第一耦合部和第二耦合部分离，第一限位通道呈解锁状态，第二段不再受到第一限位通道的约束，从而第一控制丝可与第一限位通道分离，以使第一控制丝与假体分离。进一步，还可使假体的基座与输送装置的连接轴拆卸，以将输送装置和假体分离，继而便于将输送装置 从人体中撤回，以完成植入手术。如此，在实施微创手术的过程中，需操控假体时，可通过输送装置的第一控制丝安全可靠地调整假体中的第一活动件，实现假体状态的改变。
在本申请实施例中，在配置第一控制丝与假体时，仅需将控制丝自输送装置近端延伸至输送装置远端并伸至第一限位通道处，再使得第一限位通道处于锁定状态将第一控制丝的第二段约束在第一限位通道处，即可利用与第二段相连的第一段来操控假体的第一活动件，而无需如在先技术般需先从输送装置近端延伸至远端且在穿过假体后再从输送装置远端延伸至输送装置近端，从而避免控制丝如在先技术般易出现打结、卡塞以降低手术风险。
为使本申请实施例的目的、技术方案和优点更加清楚，下面将结合附图对本申请的各实施例进行详细的阐述。
参见图1至图22，本申请一些实施例提供的假体系统，包括：假体和输送装置100；假体包括基座210和第一活动件，基座210具有座体211以及设置于座体211的第一耦合部212和第一限位部213；输送装置100包括连接轴110和第一控制丝120，连接轴110具有轴体111以及设置于轴体111的第二耦合部112和第二限位部113，第二耦合部112用于与第一耦合部212可拆卸地耦合，第二限位部113用于与第一限位部213共同形成第一限位通道300，第一控制丝120具有相连的第一段121和第二段122，第一段121用于独立地驱动第一活动件运动；第一限位部213和第二限位部113被配置为，当第一耦合部212和第二耦合部112耦合时，第一限位部213与第二限位部113之间形成呈锁定状态的第一限位通道300，第二段122被约束在第一限位通道300处；当第一耦合部212和第二耦合部112分离后，第一限位部213与第二限位部113之间形成呈解锁状态的第一限位通道300，第一控制丝120可与第一限位通道300分离。
如此，可使得第一耦合部212与第一限位部213的位置相互独立以简化第一耦合部212与第一限位部213的设计与制造的难度，同样使得第二耦合部112与第二限位部113的位置相互独立以简化第二耦合部112与第二限位部113的设计与制造的难度。进一步，可实现在第一耦合部212与第二耦合部112耦合时，第一限位部213与第二限位部113能够相互配合以形成呈锁定状态的第一限位通道300。
在一些实施例中，第一限位通道300与连接轴110轴线呈角度设置。进一步，第一限位通道300的延伸方向与连接轴110轴线之间具有大于0°且小于180°的夹角。在一些实施例中，第一限位通道300的延伸方向与连接轴110轴线相互垂直。
参见图6至图10，在一些实施例中，第一耦合部212与第一限位部213沿座体211周向间隔设置于座体211的近端；第二耦合部112与第二限位部113沿轴体111周向对应地设置于轴体111的远端。
进一步，第二耦合部112与第二限位部113沿轴体111周向对应地设置是指，第二耦合部112与第二限位部113沿轴体111周向依次设置，第二耦合部112设置在与第一耦合部212对应的位置，以形成耦合处，从而实现基座210与连接轴110之间的耦合；且第二限位部113设置在与第一限位部213对应的位置，以形成第一限位通道300。
在一些实施例中，第一耦合部212或第二耦合部112相对于连接轴110的轴向偏置布置；当偏置布置的耦合部被驱使沿连接轴110的轴向布置时，第一耦合部212和第二耦合部112耦合。
需要说明的是，本申请对当偏置布置的耦合部(第一耦合部212或第二耦合部112)被驱使沿连接轴110的轴向布置时，第一耦合部212与第二耦合部112耦合的具体方式不做限定。
进一步，第一耦合部212和第二耦合部112中的一者具有凸起101、另一者具有凹槽102；其中，当第一耦合部212或第二耦合部112相对于连接轴110的轴向偏置时，凸起101与凹槽102分离；当偏置的耦合部被驱使沿连接轴110的轴向布置时，凸起101容纳于凹槽102中。如此，即可利用凸起101容纳与凹槽102中，来实现第一耦合部212与第二耦合部112之间的耦合，进而实现连接轴110与基座210之间的耦合。
参见图6至图12，第二耦合部112还具有向内偏置的支撑件103，凸起101位于支撑件103的远端、且垂直于支撑件103的轴线方向向外凸伸；基座210设有用于容纳第二耦合部112的容纳道104，凹槽102设置于容纳道104的内壁面；当支撑件103被驱使偏转以使支撑件103的轴线沿连接轴110轴向布置时，凸起101容纳于凹槽102中。如此，即可实现“当偏置的耦合部被驱使沿轴体111轴向布置时，凸起101容纳于凹槽102中”，从而实现连接轴110与基座210之间的连接。
替代性的，第二耦合部112还具有向外偏置的支撑件103，凸起101位于支撑件103的远端、且垂直于支撑件103的轴线方向向内凸伸；凹槽102设置在基座210的外壁面；当支撑件103被驱使偏转以使支撑件103的轴线沿连接轴110轴向布置时，凸起101容纳于凹槽102中。如此，也可实现“当偏置的耦合部被驱使沿轴体111轴向布置时，凸起101容纳于凹槽102中”，从而实现连接轴110与基座210之间的连接。
需要说明的是，在另外一些替代性例子中，也可由支撑件103上设有凹槽102，而在基座210对应凹槽102的位置设有凸起101。如此，当支撑件103偏转时，可使得支撑件103上的凹槽102容纳凸起101，从而实现“当偏置的耦合部被驱使沿轴体111轴向布置时，凸起101容纳于凹槽102中”，进而实现连接轴110与基座210之间的连接。
还需说明的是，在再一些替代性例子中，支撑件103也可设置在基座210上，凸起101 以及凹槽102的配置方式可参考前述实施例中记载的内容，在此不再赘述。
本申请中，对如何实现驱使偏置布置的耦合部沿连接轴110的轴向布置的具体方式不做限定。
在一些实施例中，输送装置100还包括：中心杆130，中心杆130被配置为当中心杆130中的部分位于第一耦合部212与第二耦合部112的耦合处时，中心杆130驱使偏置布置的耦合部沿连接轴110的轴向布置。进一步，当中心杆130向第一耦合部212与第二耦合部112的耦合处移动时，中心杆130推动偏置布置的耦合部，使得偏置布置的耦合部向连接轴110的轴向偏转，中心杆130中的部分位于第一耦合部212与第二耦合部112的耦合处时实现偏置布置的耦合部沿连接轴110的轴向布置，进而利于连接轴110与基座210之间的连接。
参见图12至图14，沿连接轴110的轴向布置的容纳道104还可以同时设置在连接轴110和基座210，中心杆130可移动地设置于容纳道104；当中心杆130置于连接轴110和基座210的耦合处时，即可驱使偏置布置的耦合部沿连接轴110轴向布置。在此例子中，第二耦合部112包括上述实施例中提及的向内偏置的支撑件103，中心杆130置入容纳道104后，中心杆130从连接轴110近端向远端移动并穿过第二耦合部112和第一耦合部212时，与支撑件103抵接，而使支撑件103被驱使向外偏转，待支撑件103的轴线与连接轴110的轴线平行时，即可使得凸起101容纳于凹槽102中，从而实现连接轴110与基座210耦合。
替代性的，中心杆130为中空杆；当中心杆130套设在连接轴110和基座210的耦合处时，即可驱使偏置布置的耦合部沿连接轴110轴向布置。在此例子中，第二耦合部112包括上述提及的向外偏置的支撑件103，中心杆130向远端移动并套设在第二耦合部112和第一耦合部212耦合处时，中心杆130与支撑件103抵接，而使支撑件103被驱使向内偏转，待支撑件103的轴线与连接轴110的轴线平行时，即可使得凸起101容纳于凹槽102中，从而实现连接轴110与基座210连接。进一步，中心杆130可设有从中心杆130的远端至近端轴向延伸的避让道，避让道在连接轴110周向上与第一限位通道300对应设置，避让道用于避让从第一限位通道300处伸出的第一控制丝120，以利于第一控制丝120控制第一活动件。
本申请中，对第一限位部213与第二限位部113之间形成第一限位通道300的具体方式不做限定。
参见图13至图15，在一些实施例中，第一限位部213与第二限位部113中的一者具有第一插销105、另一者具有第一通槽107，第一通槽107与连接轴110呈角度布置，且第一通槽107在与第一插销105相对的侧壁设有第一开口106，第一插销105用于经由第一开口106插入第一通槽107以占据限制空间；当第一耦合部212和第二耦合部112耦合时，第一插销105插入第一通槽107并占据限制空间，第一通槽107所限定的剩余部分的空间形成呈锁定 状态的第一限位通道300；当第一耦合部212和第二耦合部112分离后，第一插销105位于第一通槽107外部，第一通槽107所限定的空间形成解锁状态的第一限位通道300。
进一步，第一控制丝120的第二段122的径向尺寸至少大于与第二段122相连的部分第一段121的径向尺寸，第一通槽107所限定的空间被配置为可以容纳第二段122。由此，第一控制丝120可以在第一通槽107所限定的空间中自由移动，从而可以从第一限位通道300中分离。当第一耦合部212和第二耦合部112耦合时，可使得连接轴110与基座210固定，以实现连接轴110与基座210之间无法产生相对移动，同时第一插销105通过第一开口106插入第一通槽107内。由此，第一插销105占据了第一通槽107所限定的部分空间(即限制空间)，而剩余部分的空间的最小径向尺寸被配置为小于第二段122的径向尺寸，且至少大于与第二段122相连的部分第一段121的径向尺寸，以使第一控制丝120的第二段122无法在其中自由移动，被约束在第一限位通道300中。此时，第一通槽107所限定的剩余部分的空间形成呈锁定状态的第一限位通道300。
当第一耦合部212和第二耦合部112拆卸后，第一插销105脱离第一通槽107。由于，第一通槽107所限定的空间各部分的径向尺寸被配置为均等于或大于第二段122的径向尺寸，以容纳第二段122。所以，第一控制丝120可以在第一通槽107所限定的空间中自由移动，从而可以从第一限位通道300中分离。此时，第一通槽107所限定的空间形成解锁状态的第一限位通道300。
在本实施例中，锁定状态的第一限位通道300为受限的空间，解锁状态的第一限位通道300为不受限的空间或者受限较小的空间。如此实现，通过控制第一限位通道300是否受限或者受限大小，实现第一控制丝120被约束或可释放。
需要说明的是，第一通槽107与连接轴110呈角度布置，可参考前述内容中的第一限位通道300与连接轴110呈角度布置，在此不再赘述。在一些实施例中，第一通槽107的延伸方向与连接轴110轴线相互垂直。
本实施例中的径向尺寸，是指垂直于延伸方向的截面的尺寸。如第一限位通道300的径向尺寸为第一限位通道300在垂直于其延伸方向上的截面尺寸。当第一限位通道300的截面为圆形通道时，则第一限位通道300的径向尺寸为第一限位通道300的截面的直径。而当第一限位通道300为非圆形通道时，则第一限位通道300的径向尺寸为按照特定规则得出的尺寸，如：从其截面的几何中心到截面上某点的距离的两倍。在一些实施例中，第一限位通道300的尺寸为第一限位通道300截面的外接圆的直径。在一些实施例中，第一限位通道300的尺寸为第一限位通道300截面的内切圆的直径。在一些实施例中，第一限位通道300的尺寸为其截面的几何中心到截面边缘所有点的距离中最小距离值的两倍。在一些实施例中，第 一限位通道300的尺寸为其截面的几何中心到截面边缘所有点的距离中最大距离值的两倍。本领域技术人员可以根据需求选择合适的规则。第一控制丝120各处的径向尺寸乃至于其他零部件的径向尺寸亦是如此约定，在此不再赘述。
本实施例对第二段122的形状没有特别的限制，例如第二段122可以为线状、球状、半球状、球冠状、球缺状或者椭圆体状。
在一些例子中，如上所述，连接轴110设有容纳道104，或连接轴110和基座210均设有容纳道104；第一通槽107与容纳道104部分相交形成重合空间，重合空间包括上述的限制空间；当第一耦合部212和第二耦合部112耦合时，第一插销105伸至容纳道104内且占据重合空间中的限制空间，以形成锁定状态的第一限位通道300；当第一耦合部212和第二耦合部112分离时，第一插销105位于重合空间外部，以形成解锁状态的第一限位通道300。
在一个例子中，容纳道104包括设置在连接轴110上的第二容纳段114，以及设置在基座210上的第一容纳段214。此时，当第一耦合部212和第二耦合部112耦合时，设置在连接轴110上的第一插销105伸至第一容纳段214内且占据限制空间，以形成锁定状态的第一限位通道300；当第一耦合部212和第二耦合部112分离时，第一插销105位于重合空间外部，以形成解锁状态的第一限位通道300。替代性地例子中，当第一耦合部212和第二耦合部112耦合时，设置在基座210上的第一插销105伸至第二容纳段114内且占据限制空间，以形成锁定状态的第一限位通道300；当第一耦合部212和第二耦合部112分离时，第一插销105位于重合空间外部，以形成解锁状态的第一限位通道300。
在又一个例子中，当第一通槽107设置在第二限位部113上时，连接轴110设有上述的容纳道104。进一步，容纳道104包括设置在连接轴110上的第二容纳段114。此时，当第一耦合部212和第二耦合部112耦合时，第一插销105伸至第二容纳段114内且占据限制空间，以形成锁定状态的第一限位通道300；当第一耦合部212和第二耦合部112分离时，第一插销105位于重合空间外部，以形成解锁状态的第一限位通道300。
更进一步的，在一些例子中，第一通槽107包括第一端和第二端，第一端位于第二段122远离第一段121的一侧，第二端位于第二段122靠近第一段121的一侧；第一端被配置为封闭的，以防止第二段122窜出；第一段121通过第二端延伸出第一通道。
需要说明的是，本申请对“第一端被配置为封闭的”的具体实现方式不做限定。示范性的，第一端通过封堵件进行封堵而使得第一端为封闭的。替代性的，在形成第一通道时，第一端不开口，而使得第一端为封闭的。
通过使得第一端配置为封闭的，可避免第二段122从第一端处窜出第一通道，进而避免第二段122在实施手术时与其他零部件或人体组织卡塞，以降低手术风险。
在一些替代性实施例中，第一限位部213与第二限位部113中的一者具有第二插销、另一者具有第二通槽，第二通槽被配置为第二通槽所限定的空间的最小径向尺寸处只能容纳第一控制丝120的第一段121，且第二通槽在朝向第二插销的方向轴向延伸、且形成第一槽口，第二插销用于通过第一槽口嵌入第二通槽；当第一耦合部212和第二耦合部112耦合时，第二插销嵌入第二通槽的第一槽口，第二通槽所限定的封闭的剩余部分空间形成呈锁定状态的第一限位通道300；当第一耦合部212和第二耦合部112分离后，第二插销位于第二通槽的外部，第二通槽所限定的空间形成解锁状态的第一限位通道300。
与上述实施例的区别在于，在本实施例中，第二通槽所限定的空间中，只有远离第二段122的部分空间的径向尺寸大于第一控制丝120的第一段121的径向尺寸，而其余部分空间的径向尺寸小于第一控制丝的第二段122的径向尺寸，同时至少大于与第二段122连接的部分第一段121的径向尺寸。如此，第二通槽所限定的空间只有部分可以容纳第一控制丝120的第二段122，而其余部分只能容纳第一段121。又或者，第二通槽所限定的全部空间的径向尺寸小于第一控制丝的第二段122的径向尺寸，同时至少大于与第二段122相连接的部分第一段121的径向尺寸。如此，第二通槽所限定的全部空间都只能容纳第一控制丝120的第一段121，第二段122则位于外部。此时，第一控制丝120都无法直接抽出。同时，第二通槽在朝向第二插销的方向轴向延伸、且形成第一槽口，第一控制丝120可以从第一槽口与第二通槽分离。
如此，当第一耦合部212和第二耦合部112耦合时，可使得连接轴110与基座210固定，以实现连接轴110与基座210之间无法产生相对移动，同时将第二插销嵌入第二通槽的第一槽口内，第一槽口被第二插销遮蔽，而使得第二通槽所限定的空间封闭形成呈锁定状态的第一限位通道300，第二段122被约束在所述第一限位通道300处，第一控制丝120无法从第一槽口与第二通槽分离。
当第一耦合部212和第二耦合部112分离，同时使第二插销够脱离第一槽口，第二通槽所限定的空间开放，形成解锁状态的第一限位通道300，第一控制丝120可以从第一槽口与第二通槽分离。
在本实施例中，锁定状态的第一限位通道300为封闭的空间，解锁状态的第一限位通道300为开放的空间。如此实现，通过控制第一限位通道300是否封闭，实现第一控制丝120被约束或可释放。
在一些替代性实施例中，第一限位部213与第二限位部113中的一者具有第三插销、另一者具有第三通槽，第三通槽被配置为第三通槽所限定的空间能容纳第一控制丝120，第三通槽在朝向第三插销的方向轴向延伸，且形成第二槽口，而第三插销用于通过第二槽口嵌入 第三通槽，以占据限制空间。与上述第二插销的实施例区别在于，第三插销的嵌入使第三通槽所形成的空间受限，不能再容纳第二段122，可容纳与第二段122相连接的部分第一段121，而使第二段122被约束在第一限位通道300。当第一耦合部212和第二耦合部112耦合时，第三插销通过第二槽口嵌入第三通槽并占据所述限制空间，第三通槽所限定的剩余部分空间形成呈锁定状态的第一限位通道300；当第一耦合部212和第二耦合部112分离后，第三插销位于第三通槽的外部，第三通槽所限定的空间形成解锁状态的第一限位通道300。
与上述第一插销的实施例的类似之处在于，处于解锁状态的第一限位通道300的径向尺寸大于第一控制丝120的第二段122的径向尺寸，以至少容纳第一控制丝120的第二段122以及与第二段122相连接的部分第一段121；处于锁定状态的第一限位通道300的最小径向尺寸小于第一控制丝120的第二段122的径向尺寸，大于第一控制丝120的第一段121的径向尺寸。与上述实施例的区别在于，在本实施例中，第三插销在轴向方向上限制第一限位通道300，以使第二段122被约束在第一限位通道300。
在本实施例中，锁定状态的第一限位通道300为受限的空间，解锁状态的第一限位通道300为不受限的空间。如此实现，通过控制第一限位通道300是否受限，实现第一控制丝120被约束或可释放。
在另一些实施例中，第一耦合部212与第一限位部213沿座体211周向间隔设置于座体211的近端；第二限位部113设置于轴体111的远端，第二耦合部112设置于第二限位部113上。
在一些例子中，第一耦合部212和第二耦合部112中的一者具有凸出108、另一者具有设置有开口端的双向槽109。其中，双向槽109的延伸方向为同时周向和轴向延伸，或者双向槽109的延伸方向为先轴向延伸再周向延伸；凸出108的径向尺寸与双向槽109的径向尺寸相匹配，以使凸出108能容纳于双向槽109。凸出108从双向槽109的开口端进入双向槽109内，并移动至双向槽109的另一端，以实现第一耦合部212与第二耦合部112耦合。凸出108从双向槽109的另一端向双向槽109的开口端移动至脱离双向槽109的开口端，以实现第一耦合部212与第二耦合部112分离。
在一个例子中，如图16至图18所示，凸出108设置于轴体111的远端，双向槽109设置于座体211的近端。双向槽109包括第一延伸部分A和第二延伸部分B，第一延伸部分A从开口端沿轴向向远端延伸，第二延伸部分B从第一延伸部分A的另一端开始周向延伸，第一延伸部分A和第二延伸部分B形成类似“L”形状。当第一耦合部212与第二耦合部112耦合时，凸出108从双向槽109的开口端进入第一延伸部分A，并轴向向远端移动，进入第二延伸部分B后再在第二延伸部分B中移动至双向槽109的另一端，实现第一耦合部212与 第二耦合部112耦合。另一方向，凸出108从双向槽109的另一端在第二延伸部分B中反向移动，进入第一延伸部分A再在第一延伸部分A向双向槽109的开口端移动至脱离双向槽109的开口端，以实现第一耦合部212与第二耦合部112分离。在一些实施例中，座体211的内壁设有轴向延伸的第一浅槽(图中未示出)，轴体111的外壁设有轴向延伸的第二浅槽(图中未示出)。当凸出108与双向槽109耦合时，第一浅槽和第二浅槽配合形成限制通道，限制通道用于容纳限制丝，以进一步阻止连接轴110和基座210之间周向相对转动。如此，使得第一耦合部212与第二耦合部112之间的耦合更加可靠。
在本实施例中，第一限位部213和第二限位部113的配合方式可以参考上述的实施例。但是在本实施例中，由于第一耦合部212在与第二耦合部112耦合过程中需要两者相对轴向运动。因此，第二限位部113可以设置在轴体111的远端；第二耦合部112可以设置于轴体111的远端，也可以设置于第二限位部113上，以便于第一限位部213的设置。同时，由于第一耦合部212在与第二耦合部112耦合过程中需要两者相对周向运动，在一些实施例中，第二限位部113为圆柱形插销。如此，不论第一耦合部212在与第二耦合部112如何旋转，都能保证处于锁定状态的第一限位通道不会转换为解锁状态。
进一步，当第二限位部113为圆柱形的第一插销105时，当凸出108进入双向槽109，第一插销105通过第一开口插入第一通槽107内以占据限制空间，使得第一通槽107所限定的空间形成锁定状态的第一限位通道300；当凸出108位于双向槽109外部时，第一插销105位于第一通槽107外部，以使得第一通槽107所限定的空间形成解锁状态的第一限位通道300。当第二限位部113为圆柱形的第二插销或者第三插销时，相应的第二通槽、第三通槽的横截面形状也为圆形，且延切线方向设有通道开口，以便于第一控制丝120进入。
需要说明的是，在此实施例中，还可设有第三限位部215，第一插销105与第三限位部215之间相互配合形成用于与第二控制丝140配合的第二限位通道400，其中，第一插销105与第三限位部215形成第二限位通道400的配合方式可参考第一插销105与第一限位部213形成第一限位通道300的配合方式，在此不再赘述。如此，即可利用一个第一插销105与两个限位部(即第一限位部213以及第三限位部215)配合。
此外，本申请对连接轴110和基座210可拆卸地耦合的具体方式不限于上述描述的实施例。除了上述实施例中提供的方式之外，还可以为其他任一合适的方式。例如，中国专利文献CN102395331B说明书附图中的图84至图88以及说明书中相关文字所示的耦合方式等。
在一些实施例中，第一控制丝120还包括第三段，第三段与第一段121分别位于第二段122的两侧。当第一限位通道300呈锁定状态时，第一段121和第三段使第二段122被约束于第一限位通道300内；当第一耦合部212和第二耦合部112分离时，第一限位通道300呈 解锁状态，所述第一控制丝120可与所述第一限位通道300分离。
在一个例子中，第一控制丝120的第一段121、第三段至少与第二段122相连处的径向尺寸大于第二段122的径向尺寸，而第一限位部213与第二限位部113中的一者具有上述的第一插销105、另一者具有上述的第一通槽107。第一通槽107所限定空间的径向尺寸被配置为大于第三段、第一段121的径向尺寸。如此，可确保当第一限位通道300呈解锁状态时，第三段、第一段121能从第一限位通道300中抽出，以便于将第一控制丝120与假体分离。同时，呈锁定状态的第一限位通道300的最小径向尺寸被配置为小于第三段至少与第二段122相连处的径向尺寸，小于第一段121至少与第二段122相连处的径向尺寸，大于第二段122的径向尺寸。如此，当第一限位通道300锁定时，第一段121、第三段可以使第二段122被约束于第一限位通道300中。
在又一个例子中，第一控制丝120的第一段121、第三段至少与第二段122相连处的径向尺寸大于第二段122的径向尺寸，而第一限位部213与第二限位部113中的一者具有第二插销、另一者具有第二通槽。第二通槽的径向尺寸被配置为小于第一段121、第三段的径向尺寸，且大于第二段122的径向尺寸。如此，第二段122被约束无法从第一控制丝120的轴向抽出，只能从第一槽口分离。当第一限位通道300呈解锁状态时，第一槽口处于开放，第二段122能从第二通槽的第一槽口中抽出，实现第一控制丝120与假体分离。而当第一限位通道300呈锁定状态时，第一槽口被第二插销遮蔽，第二段122无法从第一槽口抽出，只能被约束于第一限位通道300中。
进一步的，假体还包括第二活动件，第三段用于独立地驱动第二活动件运动。如此，即可实现利用一根控制丝(即第一控制丝120)控制两个活动件(即第一活动件以及第二活动件)运动。
继续参见图1至图22，进一步的，基座210还具有设置于座体211的第三限位部215；连接轴110还具有设置于轴体111的第四限位部115，第四限位部115用于与第三限位部215共同形成第二限位通道400；假体还包括第二活动件；输送装置100还包括第二控制丝140，第二控制丝140具有依次相连的第四段和第五段，第五段用于独立地驱动第二活动件运动；第三限位部215和第四限位部115被配置为，当第一耦合部212和第二耦合部112耦合时，第三限位部215与第四限位部115之间形成呈锁定状态的第二限位通道400，第四段被约束在第二限位通道400处；当第一耦合部212和第二耦合部112分离后，第三限位部215与第四限位部115之间形成呈解锁状态的第二限位通道400，第二控制丝140可与第二限位通道400分离。
需要说明的是，此实施例中的第二控制丝140的第四段与第五段之间的配置关系，可参 考上述实施例中的第一控制丝120的第一段121与第二段122之间的配置关系，在此不在赘述。
还需说明的是，此实施例中的第二控制丝140同由第三限位部215和第四限位部115形成的第二限位通道400之间的配置关系，可参考上述实施例中的第一控制丝120同由第一限位部213和第二限位部113形成的第一限位通道300之间的配置关系，在此不在赘述。
此外，此实施例中的“第三限位部215与第四限位部115”和“第一耦合部212与第二耦合部112”之间的配置关系，可参考上述实施例中的“第一限位部213与第二限位部113”和“第一耦合部212与第二耦合部112”之间的配置关系，在此不在赘述。
在一些实施例中，第一限位部213与第三限位部215相对设置在座体211轴线的两侧，第二限位部113与第四限位部115的位置关系根据第一限位部213与第三限位部215的位置关系相应地设置。如此，可便于在座体21上形成第一限位部213与第三限位部215，在轴体111上形成第二限位部113与第四限位部115，并且便于耦合部的设置。
此外，还可使得“第一限位部213与第二限位部113形成的第一限位通道300”和“第三限位部215与第四限位部115形成的第二限位通道400”相对设置，继而当第一限位通道300约束第二段122，以及第二限位通道400约束第四段，且在操控第一控制丝120的第一段121以及第二控制丝140的第五段时，可使得输送装置100乃至于假体的受力较为均匀。
更进一步的，第一耦合部212中包含多个第一耦合件(例如上述实施例中的凸起或凹槽)，且周向均匀布置，第二耦合部112中包含的多个第二耦合件(例如上述实施例中的凹槽或凸起)，第二耦合件的布置与第一耦合件的布置相对应；第一耦合件用于和与其对应布置的第二耦合件可拆卸地耦合。
本申请对第一耦合件的数量以及设置位置不做限定。例如，图3、5、7、9、10、12所示，第一耦合件为两个，且对称布置。第一限位部213位于两个第一耦合件之间，第三限位部215与之对称布置。在一些实施例中，第一限位部213位于两个第一耦合件的角平分线处，即第一耦合件之间的连线同第一限位部213与第三限位部215的连线垂直。
本实施例对假体中活动件的数量没有特别的限制。假体可以只包括一个活动件，即包括上述的第一活动件。通过第一段121控制第一活动件运动，可以实现假体状态的变化。
假体还可以包括两个活动件，即包括上述的第一活动件和第二活动件，通过第一段121控制第一活动件运动，并通过第三段或第五段控制第二活动件运动，来实现假体状态的变化。当然，假体还可以包括两个以上活动件，通过控制丝来控制活动件中一个或多个运动，以来实现假体状态的变化。
上述的“状态的变化”可以是假体整体或部分的结构、尺寸、形状的变化，例如假体从压 缩态变为展开态；上述的“状态的变化”可以是实现假体与目标组织之间、假体与输送系统之间、假体内部部件之间的解锁状态、锁定状态，和/或，锁定状态与解锁状态之间的相互转化；“状态的变化”还可以是假体整体或者部分(例如第一活动件)的位置和/或姿态的变化。
以假体包括一个活动件举例来说，假体可为用于治疗主动脉狭窄的覆膜支架，一般在输送过程中采用束缚丝(即第一活动件)束缚处于压缩状态的覆膜支架，当覆膜支架定位到目标位置后，通过控制丝释放束缚丝，以实现覆膜支架从压缩状态转变为展开状态。又例如，在输送左心耳封堵器时，控制丝与左心耳封堵器之间处于锁定状态，在左心耳封堵器释放后，驱动控制丝与左心耳封堵器分离，使左心耳封堵器处于解锁状态。
以假体包括两个活动件举例来说，假体可为瓣膜夹子，瓣膜夹子通过夹合臂、夹合座的运动来实现对瓣叶边缘的夹持，来治疗瓣膜逆流。在瓣膜夹子夹持瓣叶边缘的过程中，通过控制丝来控制夹合臂的运动，改变夹合臂的姿态。
参见图19，以假体为用于治疗二尖瓣返流的瓣膜夹子即二尖瓣夹子200为例，做进一步的解释说明。需要强调的是，这里的假体为二尖瓣夹子200仅是举例说明。在其他的一些实施例中，假体也可是三尖瓣夹子等用于治疗其他瓣膜反流的瓣膜夹子。在另外的一些实施例中，假体用于其他疾病的治疗、诊断的介入或植入医疗器械。本申请对假体的具体类型不做限定。
在一些实施例中，二尖瓣夹子200包括基座210、夹合臂(即活动件)以及夹合座，夹合臂和夹合座可以相对于基座210的轴线转动。夹合臂位于基座210的近端，夹合座位于基座210的远端。
进一步，夹合臂包括第一夹合臂220(即第一活动件)和第二夹合臂230(即第二活动件)，两者关于基座210的轴线对称布置。每个夹合臂都包括自由端和连接端，夹合臂可相对于基座210转动，进而使自由端可靠近或远离基座。
仍需强调的是，这里的第一活动件为第一夹合臂220，以及第二活动件为第二夹合臂230也仅是在假体为二尖瓣夹子200的情况下进行的举例说明，在其他的实施例中，第一活动件也可不为第一夹合臂220，以及第二活动件也可不为第二夹合臂230，本申请对第一活动件以及第二活动件的具体类型也不做限定。
同样，夹合座包括第一夹合座240和第二夹合座250，两者关于基座210的轴线对称布置，且位于第一夹合臂220和第二夹合臂230所在的平面上，以更好的夹合二尖瓣500前后瓣叶的边缘。如此，第一夹合座240与第一夹合臂220形成了第一夹合区域；第二夹合座250与第二夹合臂230形成了第二夹合区域。这里，“第一夹合臂220和第二夹合臂230所在的平面”是指第一夹合臂220的轴线和第二夹合臂230的轴线所形成的平面；“第一夹合座240和 第二夹合座250位于第一夹合臂220和第二夹合臂230所在的平面上”，是指第一夹合座240和第二夹合座250的轴线均位于第一夹合臂220和第二夹合臂230所在的平面。在二尖瓣夹子200输送到二尖瓣500目标位置后，通过驱动夹合臂和夹合座的转动，扩大第一夹合区域和第二夹合区域，以使二尖瓣前后瓣的边缘落入夹合区域，然后逐渐减小夹合区域，以将二尖瓣500的前后瓣叶夹持在夹合臂和夹合座之间，实现对二尖瓣返流的治疗。
继续参见图1至图3，以及图19，在一个例子中，第一夹合臂220与第二夹合臂230均为片状，且第一夹合臂220的连接端与第二夹合臂230的连接端通过过渡部221弹性连接。进一步，过渡部221设置在基座210的远端。在一些实施例中，第一夹合臂220、过渡部221与第二夹合臂230一体成型，形成类似倒置的Ω形状。且第一夹合臂220与第二夹合臂230在自然状态下呈伸展状态。当在提拉第一段121时，第一夹合臂220被驱动发生转动以向上并向基座210靠拢，且第一夹合臂220发生弹性形变。而不再提拉推送第一段121时，在自身弹性力作用下第一夹合臂220转动以远离基座210，恢复原状。相应地，如图2所示，在提拉第三段/第五段时，第二夹合臂230被驱动发生转动以向上并向基座210靠拢，且第二夹合臂230发生弹性形变。而当不再提拉第三段/第五段时，第二夹合臂230转动以远离基座210，恢复原状。
继续参见图1至图3，以及图19，第一夹合座240和第二夹合座250均与基座210可转动连接。在一些实施例中，第一夹合座240和第二夹合座250通过同一转轴与基座210可转动连接。在一些实施例中，第一夹合座240垂直于轴线方向的横截面形状为U形，以更好地包裹二尖瓣500的第一瓣叶边缘510和第一夹合臂220。同样，第二夹合座250垂直于轴线方向的横截面形状为U形，以更好地包裹二尖瓣500的第二瓣叶边缘520和第二夹合臂230。当二尖瓣夹子200夹持二尖瓣500的瓣叶时，第一夹合座240和第二夹合座250被驱动转动，并分别和第一夹合臂220、第二夹合臂230并挤压二尖瓣500的前后瓣的瓣叶边缘，实现二尖瓣夹子200对二尖瓣500的瓣叶的夹持。
本实施例对第一段121控制第一活动件运动，第三段/第五段控制第二活动件运动的方式没有特别的限制。对于二尖瓣夹子200而言，只需第一段121可移动地连接于第一夹合臂220即可。如此，一方面，第一夹合臂220可以随着第一段121的运动而转动；另外一方面，当输送装置100需要与二尖瓣夹子200分离时，第一控制丝120可以与第一夹合臂220的分离。第三段/第五段与第二活动件(即第三段/第五段与第二夹合臂230)的关系同样如此，不再赘述。
在一些实施例中，继续参见图1，结合图20至图22，第一段121从第一限位通道300向远端延伸，在延伸至第一夹合臂220所处的位置处后，反向朝向输送装置100近端延伸。如 此，第一段121则会在第一夹合臂220所处的位置处形成弯曲部分，弯曲部分与第一夹合臂220或设置于第一夹合臂220的附件互穿，以便于控制第一夹合臂220的转动。
在此实施例中，第二段122被配置为可脱离第一夹合臂220。如此，当需将第一控制丝120从第一夹合臂220上抽离时，可确保第二段122可从第一夹合臂220上抽离。
参见图20，在一些实施例中，上述的附件为固定线222，固定线222通过捆扎、打结等方式设置于第一夹合臂220，并且固定线222形成了用于与第一段121的弯曲部分互穿的固定线本体223。
进一步，固定线本体223呈环状以形成用于与上述的弯曲部分互穿的第一通孔，固定线222还具有与固定线本体223连接的固定结224，固定结224设置在第一夹合臂220上。其中，第一段121的弯曲部分穿过第一通孔以与固定线本体223互穿。
进一步，第一夹合臂220在其表面设有第二通孔225，固定线本体223从第一夹合臂220远离基座210的一侧穿过第二通孔225，固定结224设置于第一夹合臂220远离基座210的一侧，且固定结224被配置为无法穿过第二通孔225。
替代性地，固定线222的固定结224缠绕在第二通孔225周围，以与第一夹合臂220固定连接。
参见图21，在又一些实施例中，第一夹合臂220上设有两个第三通孔226，第一段121远离第二段122的一端从第一夹合臂220远离第一夹合座240的一侧，即背离第一夹合区域的一侧，穿过一第三通孔226，然后从第一夹合臂220的靠近第一夹合座240的一侧，即面对第一夹合区域的一侧，穿过另一第三通孔226，然后反向朝向输送装置100近端延伸。如此，即可形成第一段121的弯曲部分，即可使得第一段121的弯曲部分与第一夹合臂220互穿。
替代性地，第一夹合臂220上设有多于两个的偶数个第三通孔226，第一段121远离第二段122的一端交替穿过这些第三通孔226，然后反向朝向输送装置100近端延伸。如此，亦可形成第一段121的弯曲部分，并且弯曲部分与第一夹合臂220互穿。
参见图22，在再一些实施例中，第一夹合臂220上设有凸块227，第一夹合臂220上的凸块227上设有第四通孔228，第一段121远离第二段122的一端穿过第四通孔228。如此，亦可形成第一段121的弯曲部分，并且弯曲部分与第一夹合臂220互穿。在一些实施例中，第四通孔228的延伸方向与第一夹合臂220的延伸方向同向。
需要说明的是，第三段/第五段与第二夹合臂230之间的连接方式可参考上述第一段121与第一夹合臂220之间的连接方式，在此不再赘述。
另外，第四段也可均被配置为可脱离第二夹合臂230。如此，当需将第二控制丝140从 第二夹合臂230上抽离时，可确保第四段可从第二夹合臂230上抽离。
进一步，二尖瓣夹子200还包括：致动组件，致动组件用于控制第一夹合座240和第二夹合座250的转动。
继续参考图1至图3，致动组件包括第一连杆261、第二连杆262以及滑块263。其中，第一连杆261近端与第一夹合座240可转动连接，远端与滑块263可转动连接，滑块263可以相对于基座210轴向移动。由此，第一连杆261，第一夹合座240，基座210以及滑块263形成类似于曲柄滑块机构的运动机构。当滑块263被驱动靠近或远离基座210时，第一夹合座240被驱动发生转动运动。同样，第二连杆262近端与第二夹合座250可转动连接，远端与滑块263可转动连接。同样，第二连杆262，第二夹合座250，基座210以及滑块263也形成类似于上述的曲柄滑块机构的运动机构。当滑块263被驱动靠近或远离基座210时，第二夹合座250被驱动发生转动运动。
进一步，滑块263呈“T”字形，即滑块263包括水平部分和竖直部分。第一基座210为中空结构，滑块263的竖直部分可移动地容纳于第一基座210中。滑块263的水平部分的两端分别与第一连杆261和第二连杆262转动连接，滑块263的竖直部分与中心杆130可拆卸连接，例如螺纹连接。如此，可以通过中心杆130驱动滑块263相对移动，以使第一夹合座240，第二夹合座250转动。在一些实施例中，第一连杆261、第二连杆262关于基座210的轴线对称布置。如此，在滑块263带动第一夹合座240以及第二夹合座250移动时，第一夹合座240的转动角度与第二夹合座250的转动时转动角度相同。
在一些实施例中，输送装置100还包括：套设在连接轴110上的导管150，导管150设有沿导管150轴向延伸的两个通道；第一段121远离第二段122的一端自一个通道远端穿过通道并延伸至该通道近端；第三段远离第二段122的一端自另一个通道远端穿过通道并延伸至该通道近端，或第五段远离第四段的一端自另一个通道远端穿过通道并延伸至该通道近端。
如此，可便于操作者在导管150近端提拉第一段121远离第二段122的一端以调整第一夹合臂220的转动角度，以及便于操作者在导管150近端提拉第三段或第五段远离第四段的一端以调整第二夹合臂230的转动角度，防止其他部件乃至人体组织的干涉。
当需要将第一控制丝120以及第二控制丝140与二尖瓣夹子200分离时，将第一限位通道300以及第二限位通道400均调整至解锁状态，操作者在导管150近端抽拉第一段121远离第二段122的一端，以及抽拉第三段或第五段远离第四段的一端，实现第一控制丝120以及第二控制丝140与二尖瓣夹子200的分离。
以上对本申请实施例提供的假体系统进行了详细地介绍，本文中应用了具体个例对本申请的原理及实施例进行了阐述，以上实施例的说明只是用于帮助理解本申请的思想，在具体 实施例及应用范围上均会有改变之处，综上所述，本说明书的内容不应理解为对本申请的限制。

Claims (29)

  1. 一种假体系统，其特征在于，包括：假体和输送装置(100)；
    所述假体包括基座(210)和第一活动件，所述基座(210)具有座体(211)以及设置于所述座体(211)的第一耦合部(212)和第一限位部(213)；
    所述输送装置(100)包括连接轴(110)和第一控制丝(120)，所述连接轴(110)具有轴体(111)以及设置于所述轴体(111)的第二耦合部(112)和第二限位部(113)，所述第二耦合部(112)用于与所述第一耦合部(212)可拆卸地耦合，所述第二限位部(213)用于与所述第一限位部(213)共同形成第一限位通道(300)，所述第一控制丝(120)具有相连的第一段(121)和第二段(122)，所述第一段(121)用于独立地驱动所述第一活动件运动；
    所述第一限位部(213)和所述第二限位部(113)被配置为，当所述第一耦合部(212)和所述第二耦合部(112)耦合时，所述第一限位部(213)与所述第二限位部(113)之间形成呈锁定状态的所述第一限位通道(300)，所述第二段(122)被约束在所述第一限位通道(300)处；当所述第一耦合部(212)和所述第二耦合部(112)分离后，所述第一限位部(213)与所述第二限位部(113)之间形成呈解锁状态的所述第一限位通道(300)，所述第一控制丝(120)可与所述第一限位通道(300)分离。
  2. 根据权利要求1所述的假体系统，其特征在于，所述第一耦合部(212)与所述第一限位部(213)沿所述座体(211)周向间隔设置于所述座体(211)的近端；所述第二耦合部(112)与所述第二限位部(113)沿所述轴体(111)周向对应地设置于所述轴体(111)的远端；
    或者，
    所述第一耦合部(212)与所述第一限位部(213)沿所述座体(211)周向间隔设置于所述座体(211)的近端；所述第二限位部(113)设置于所述轴体(111)的远端，所述第二耦合部(112)设置于所述第二限位部上(113)。
  3. 根据权利要求1所述的假体系统，其特征在于，
    所述第一耦合部(212)或所述第二耦合部(112)相对于所述连接轴(110)的轴向偏置布置；
    当偏置布置的所述耦合部被驱使沿所述连接轴(110)的轴向布置时，所述第一耦合部(212)和所述第二耦合部(112)耦合。
  4. 根据权利要求3所述的假体系统，其特征在于，
    所述第一耦合部(212)和所述第二耦合部(112)中的一者具有凸起(101)、另一者具 有凹槽(102)；
    其中，当所述第一耦合部(212)或所述第二耦合部(112)相对于所述连接轴(110)的轴向偏置时，所述凸起(101)与所述凹槽(102)分离；当偏置的所述耦合部被驱使沿所述连接轴(110)的轴向布置时，所述凸起(101)容纳于所述凹槽(102)中。
  5. 根据权利要求4所述的假体系统，其特征在于，
    所述第二耦合部(112)还具有向内偏置的支撑件(103)，所述凸起(101)位于所述支撑件(103)的远端、且垂直于所述支撑件(103)的轴线方向向外凸伸；所述基座(210)设有用于容纳所述第二耦合部(112)的容纳道(104)，所述凹槽(102)设置于所述容纳道(104)的内壁面；当所述支撑件(103)被驱使偏转以使所述支撑件(103)的轴线沿所述连接轴(110)轴向布置时，所述凸起(101)容纳于所述凹槽(102)中；
    或者，
    所述第二耦合部(112)还具有向外偏置的支撑件(103)，所述凸起(101)位于所述支撑件(103)的远端、且垂直于所述支撑件(103)的轴线方向向内凸伸；所述凹槽(102)设置在所述基座(210)的外壁面；当所述支撑件(103)被驱使偏转以使所述支撑件(103)的轴线沿所述连接轴(110)轴向布置时，所述凸起(101)容纳于所述凹槽(102)中。
  6. 根据权利要求3所述的假体系统，其特征在于，
    所述输送装置(100)还包括：中心杆(130)，所述中心杆(130)被配置为当所述中心杆(130)中的部分位于所述第一耦合部(212)与所述第二耦合部(112)的耦合处时，所述中心杆(130)驱使偏置布置的所述耦合部沿所述连接轴(110)的轴向布置。
  7. 根据权利要求1所述的假体系统，其特征在于，
    所述第一耦合部(212)和所述第二耦合部(112)中的一者具有凸出(108)、另一者具有设置有开口端的双向槽(109)；
    其中，所述双向槽(109)的延伸方向为同时周向和轴向延伸，或所述双向槽(109)的延伸方向为先轴向延伸再周向延伸；
    所述凸出(108)的径向尺寸与所述双向槽(109)的径向尺寸相匹配，以使所述凸出(108)能容纳于所述双向槽(109)；
    所述凸出(108)从所述双向槽(109)的开口端进入所述双向槽(109)内，并移动至所述双向槽(109)的另一端，以实现所述第一耦合部(212)和所述第二耦合部(112)耦合；
    所述凸出(108)从所述双向槽(109)的另一端向所述双向槽(109)的开口端移动至脱离所述双向槽(109)的开口端，实现所述第一耦合部(212)和所述第二耦合部(112)分离。
  8. 根据权利要求1所述的假体系统，其特征在于，
    所述第一限位部(213)与所述第二限位部(113)中的一者具有第一插销(105)、另一者具有第一通槽(107)，所述第一通槽(107)与所述连接轴(110)呈角度布置，且所述第一通槽(107)在与所述第一插销(105)相对的侧壁设有第一开口(106)，所述第一插销(105)用于经由所述第一开口(106)插入所述第一通槽(107)以占据限制空间；
    当所述第一耦合部(212)和所述第二耦合部(112)耦合时，所述第一插销(105)插入所述第一通槽(107)并占据所述限制空间，所述第一通槽(107)所限定的剩余部分空间形成呈锁定状态的所述第一限位通道(300)；
    当所述第一耦合部(212)和所述第二耦合部(112)分离后，所述第一插销(105)位于所述第一通槽(107)外部，所述第一通槽(107)所限定的空间形成解锁状态的第一限位通道(300)。
  9. 根据权利要求8所述的假体系统，其特征在于，
    所述连接轴(110)设有容纳道(104)，或所述连接轴(110)和所述基座(210)设有容纳道(104)；
    所述第一通槽(107)与所述容纳道(104)部分相交形成重合空间，所述重合空间包括所述限制空间；
    当所述第一耦合部(212)和所述第二耦合部(112)耦合时，所述第一插销(105)伸至所述容纳道(104)内且占据所述重合空间中的所述限制空间，以形成锁定状态的所述第一限位通道(300)；
    当所述第一耦合部(212)和所述第二耦合部(112)分离时，所述第一插销(105)位于所述重合空间外部，以形成解锁状态的所述第一限位通道(300)。
  10. 根据权利要求9所述的假体系统，其特征在于，
    所述第一通槽(107)包括第一端和第二端，所述第一端位于所述第二段(122)远离所述第一段(121)的一侧，所述第二端位于所述第二段(122)靠近所述第一段(121)的一侧；所述第一端被配置为封闭的，以防止所述第二段(122)窜出；所述第一段(121)通过所述第二端延伸出所述第一通槽(107)。
  11. 根据权利要求8至10任一项所述的假体系统，其特征在于，
    所述第一插销(105)为圆柱形插销；所述第二耦合部(112)具有凸出(108)，所述第一耦合部(212)具有双向槽(109)；
    当所述凸出(108)与所述双向槽(109)耦合时，所述第一插销(105)通过所述第一开口(106)插入所述第一通槽(107)内以占据限制空间，使得所述第一通槽(107)所限定的空间形成锁定状态的所述第一限位通道(300)；
    当所述凸出(108)与所述双向槽(109)分离时，所述第一插销(105)位于所述第一通槽(107)外部，以使得所述第一通槽(107)所限定的空间形成解锁状态的所述第一限位通道(300)。
  12. 根据权利要求1所述的假体系统，其特征在于，
    所述第一限位部(213)与所述第二限位部(113)中的一者具有第二插销、另一者具有第二通槽，所述第二通槽被配置为所述第二通槽所限定的空间的最小径向尺寸处只能容纳所述第一控制丝(120)的第一段(121)，且所述第二通槽在朝向所述第二插销的方向轴向延伸、且形成第一槽口，所述第二插销用于通过所述第一槽口嵌入所述第二通槽；
    当所述第一耦合部(212)和所述第二耦合部(112)耦合时，所述第二插销嵌入所述第二通槽的第一槽口，所述第二通槽所限定的封闭的剩余部分空间形成呈锁定状态的所述第一限位通道(300)；
    当所述第一耦合部(212)和所述第二耦合部(112)分离后，所述第二插销位于所述第二通槽的外部，所述第二通槽所限定的空间形成解锁状态的第一限位通道(300)。
  13. 根据权利要求12所述的假体系统，其特征在于，
    所述第二插销为圆柱形插销，所述第二通槽的横截面形状为圆形；所述第二耦合部(112)具有凸出(108)，所述第一耦合部(212)具有双向槽(109)；
    当所述凸出(108)与所述双向槽(109)内耦合时，所述第二插销通过所述第一槽口插入所述第二通槽内以占据限制空间，使得所述第二通槽所限定的空间形成锁定状态的所述第一限位通道(300)；
    当所述凸出(108)与所述双向槽(109)分离时，所述第二插销位于所述第二通槽外部，以使得所述第二通槽所限定的空间形成解锁状态的所述第一限位通道(300)。
  14. 根据权利要求1所述的假体系统，其特征在于，
    所述第一限位部(213)与所述第二限位部(113)中的一者具有第三插销、另一者具有第三通槽，所述第三通槽被配置为所述第三通槽所限定的空间能容纳所述第一控制丝(120)，所述第三通槽在朝向所述第三插销的方向轴向延伸，且形成第二槽口，所述第三插销用于通过所述第二槽口嵌入所述第三通槽，以占据限制空间；
    当所述第一耦合部(212)和所述第二耦合部(112)耦合时，所述第三插销通过所述第二槽口嵌入所述第三通槽并占据所述限制空间，所述第三通槽所限定的剩余部分空间形成呈锁定状态的所述第一限位通道(300)；
    当所述第一耦合部(212)和所述第二耦合部(112)分离后，所述第三插销位于所述第三通槽的外部，所述第三通槽所限定的空间形成解锁状态的所述第一限位通道(300)。
  15. 根据权利要求14所述的假体系统，其特征在于，
    所述第三插销为圆柱形插销，所述第三通槽的横截面形状为圆形；所述第二耦合部(112)具有凸出(108)，所述第一耦合部(212)具有双向槽(109)；
    当所述凸出(108)与所述双向槽(109)耦合时，所述第三插销通过所述第二槽口插入所述第三通槽内以占据限制空间，使得所述第三通槽所限定的空间形成锁定状态的所述第一限位通道(300)；
    当所述凸出(108)与所述双向槽(109)分离时，所述第三插销位于所述第三通槽外部，以使得所述第三通槽所限定的空间形成解锁状态的所述第一限位通道(300)。
  16. 根据权利要求8或9所述的假体系统，其特征在于，
    所述第一控制丝(120)还包括第三段，所述第三段与所述第一段(121)分别位于所述第二段(122)的两侧；
    当所述第一限位通道(300)呈锁定状态时，所述第一段(121)和所述第三段使所述第二段(122)被约束于所述第一限位通道(300)内；
    当所述第一耦合部(212)和所述第二耦合部(112)分离时，所述第一限位通道(300)呈解锁状态，所述第一控制丝(120)可与所述第一限位通道(300)分离。
  17. 根据权利要求16所述的假体系统，其特征在于，
    所述第一控制丝(120)的所述第一段(121)、所述第三段至少与所述第二段(122)相连处的径向尺寸大于所述第二段(122)的径向尺寸；
    所述第一通槽(107)所限定空间的径向尺寸被配置为大于所述第三段、所述第一段(121)的径向尺寸；
    呈锁定状态的所述第一限位通道(300)的最小径向尺寸被配置为小于所述第三段至少与所述第二段(122)相连处的径向尺寸，小于所述第一段(121)至少与所述第二段(122)相连处的径向尺寸，大于所述第二段(122)的径向尺寸。
  18. 根据权利要求17所述的假体系统，其特征在于，
    所述假体还包括第二活动件，所述第三段用于独立地驱动所述第二活动件运动。
  19. 根据权利要求12所述的假体系统，其特征在于，
    所述第一控制丝(120)还包括第三段，所述第三段与所述第一段(121)分别位于所述第二段(122)的两侧；
    当所述第一限位通道(300)呈锁定状态时，所述第一段(121)和所述第三段使所述第二段(122)被约束于所述第一限位通道(300)内；
    当所述第一耦合部(212)和所述第二耦合部(112)分离时，所述第一限位通道(300) 呈解锁状态，所述第一控制丝(120)可与所述第一限位通道(300)分离。
  20. 根据权利要求19所述的假体系统，其特征在于，
    所述第一控制丝(120)的所述第一段(121)、所述第三段至少与所述第二段(122)相连处的径向尺寸大于所述第二段(122)的径向尺寸；
    所述第二通槽的径向尺寸被配置为小于所述第一段(121)、所述第三段的径向尺寸，且大于所述第二段(122)的径向尺寸；
    当所述第一限位通道(300)呈解锁状态时，所述第一槽口处于开放，所述第二段(122)能从所述第二通槽的所述第一槽口中抽出；
    而当所述第一限位通道(300)呈锁定状态时，所述第一槽口被所述第二插销遮蔽，所述第二段(122)无法从所述第一槽口抽出，只能被约束于所述第一限位通道(300)中。
  21. 根据权利要求20所述的假体系统，其特征在于，
    所述假体还包括第二活动件，所述第三段用于独立地驱动所述第二活动件运动。
  22. 根据权利要求14所述的假体系统，其特征在于，
    所述第一控制丝(120)还包括第三段，所述第三段与所述第一段(121)分别位于所述第二段(122)的两侧；
    当所述第一限位通道(300)呈锁定状态时，所述第一段(121)和所述第三段使所述第二段(122)被约束于所述第一限位通道(300)内；
    当所述第一耦合部(212)和所述第二耦合部(112)分离时，所述第一限位通道(300)呈解锁状态，所述第一控制丝(120)可与所述第一限位通道(300)分离。
  23. 根据权利要求22所述的假体系统，其特征在于，
    所述第一控制丝(120)的所述第一段(121)、所述第三段至少与所述第二段(122)相连处的径向尺寸大于所述第二段(122)的径向尺寸；
    所述第三通槽所限定空间的径向尺寸被配置为大于所述第三段、所述第一段(121)的径向尺寸；
    呈锁定状态的所述第一限位通道(300)的最小径向尺寸被配置为小于所述第三段至少与所述第二段(122)相连处的径向尺寸，小于所述第一段(121)至少与所述第二段(122)相连处的径向尺寸，大于所述第二段(122)的径向尺寸。
  24. 根据权利要求23所述的假体系统，其特征在于，
    所述假体还包括第二活动件，所述第三段用于独立地驱动所述第二活动件运动。
  25. 根据权利要求8、9、10、12或14所述的假体系统，其特征在于，
    所述基座(210)还具有设置于所述座体(211)的第三限位部(215)；
    所述连接轴(110)还具有设置于所述轴体(111)的第四限位部(115)，所述第四限位部(115)用于与所述第三限位部(215)共同形成第二限位通道(400)；
    所述假体还包括第二活动件；
    所述输送装置(100)还包括第二控制丝(140)，所述第二控制丝(140)具有依次相连的第四段和第五段，所述第五段用于独立地驱动所述第二活动件运动；
    所述第三限位部(215)和所述第四限位部(115)被配置为，当所述第一耦合部(212)和所述第二耦合部(112)耦合时，所述第三限位部(215)与所述第四限位部(115)之间形成呈锁定状态的所述第二限位通道(400)，所述第四段被约束在所述第二限位通道(400)处；当所述第一耦合部(212)和所述第二耦合部(112)分离后，所述第三限位部(215)与所述第四限位部(115)之间形成呈解锁状态的所述第二限位通道(400)，所述第二控制丝(140)可与所述第二限位通道(400)分离。
  26. 根据权利要求25所述的假体系统，其特征在于，
    所述第一限位部(213)与所述第三限位部(215)相对设置在所述座体(211)的轴线的两侧，所述第二限位部(113)与所述第四限位部(115)的位置关系根据所述第一限位部(213)与所述第三限位部(215)的位置关系相应地设置。
  27. 根据权利要求25所述的假体系统，其特征在于，
    所述第一耦合部(212)为两个，且对称布置；
    所述第一限位部(213)位于两个所述第一耦合部(212)之间，所述第三限位部(215)与之对称布置。
  28. 根据权利要求1所述的假体系统，其特征在于，
    所述假体为瓣膜夹子。
  29. 根据权利要求28所述的假体系统，其特征在于，
    所述第一活动件为第一夹合臂(220)，所述第一夹合臂(220)关于所述座体(211)的轴线转动，所述第一段(121)可移动地连接于所述第一夹合臂(220)。
PCT/CN2023/122740 2022-09-30 2023-09-28 一种假体系统 WO2024067828A1 (zh)

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