WO2024046310A1 - 一种假体系统及输送装置 - Google Patents

一种假体系统及输送装置 Download PDF

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Publication number
WO2024046310A1
WO2024046310A1 PCT/CN2023/115492 CN2023115492W WO2024046310A1 WO 2024046310 A1 WO2024046310 A1 WO 2024046310A1 CN 2023115492 W CN2023115492 W CN 2023115492W WO 2024046310 A1 WO2024046310 A1 WO 2024046310A1
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WO
WIPO (PCT)
Prior art keywords
section
preset channel
connecting shaft
base
size
Prior art date
Application number
PCT/CN2023/115492
Other languages
English (en)
French (fr)
Inventor
周冠冠
李芳�
胡占明
李文思
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
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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 WO2024046310A1 publication Critical patent/WO2024046310A1/zh

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart 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
    • A61F2/2412Heart 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 with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart 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
    • A61F2/2427Devices for manipulating or deploying heart valves during implantation
    • A61F2/2439Expansion controlled by filaments
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart 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
    • A61F2/2442Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart 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
    • A61F2/2442Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2466Delivery devices therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966Instruments 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2220/00Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements

Definitions

  • the present application relates to the technical field of medical devices, and in particular to a prosthesis system and a delivery device.
  • Minimally invasive surgery has the advantages of less trauma, less pain, and faster recovery, making it popular among patients.
  • US patent document US20210145574A1 discloses a method for performing minimally invasive surgery.
  • one end of the control wire has a convex point, and the other end passes through the connecting shaft of the delivery device and is movably connected with the prosthesis and then extends to the proximal end of the delivery device.
  • the configuration of the connecting shaft and the central rod of the delivery device is limited so that the protrusion cannot pass through the connecting shaft in the direction in which the control wire extends, so that the operator can move away from the protrusion in the control wire at the proximal end of the delivery device. Operate one end to adjust the status of the prosthesis.
  • the protrusions of the control wire are likely to jump out of the connecting shaft in the direction opposite to the direction in which the control wire extends, causing the control wire to easily interact with other parts of the delivery device or certain parts of the human body.
  • the organ becomes jammed, thereby increasing the risk of surgery.
  • the purpose of this application is to provide a prosthesis system and a delivery device that can be adjusted safely and reliably. In the absence of moving parts in the prosthesis, surgical risks are reduced.
  • a prosthesis system including a delivery device and a prosthesis;
  • the delivery device includes a connecting shaft and a control wire;
  • the prosthesis includes a base and a first movable part, wherein the base and the connecting shaft Detachable coupling; preset channel, the preset channel is arranged on the connecting shaft and/or base at an angle to the axis of the connecting shaft;
  • the control wire has a first section, a second section, a third section, and a first section connected in sequence The size of any one of the third section and at least the part connected to the second section is larger than the size of the second section, the first section is used to independently drive the first movable member to move, and the second section is accommodated in the preset channel; wherein,
  • the preset channel has a first state and a second state. When the preset channel is in the first state, the first section and the third section constrain the second section to the preset channel; when the preset channel is in the second state, the control Wir
  • the embodiment of the present application also provides a delivery device for delivering a prosthesis.
  • the prosthesis includes a base and a first movable part; the delivery device includes a connecting shaft and a control wire; the connecting shaft is detachably coupled to the base; and a preset channel , the preset channel is arranged on the connecting shaft at an angle to the axis of the connecting shaft, or the preset channel is arranged on the connecting shaft at an angle to the axis of the connecting shaft and between the connecting shaft and the base;
  • the control wire has: the first section, the second section and the The third section, the size of at least the part connected to the second section of any one of the first section and the third section is larger than the size of the second section, the first section is used to independently drive the first movable member to move, and the second section accommodates In the default channel; wherein, the default channel has a first state and a second state. When the default channel is in the first state, the first segment and the third segment constrain the second segment to the default channel;
  • the prosthesis system and delivery device when performing minimally invasive implant surgery, make the preset channel in the first state to constrain the second section to the preset position through the first and third sections of the control wire.
  • the connecting shaft transports the prosthesis to the target position in the human body through the natural orifice of the human body
  • the movement of the first movable part of the prosthesis can be adjusted by controlling the first section of the wire, so that the prosthesis
  • the state changes to achieve prosthesis implantation; when it is necessary to separate the delivery device and the prosthesis, the preset channel is in the second state.
  • the control wire can be separated from the preset channel to facilitate control.
  • the wire is separated from the prosthesis, and the control wire is extracted from the human body.
  • the connecting shaft between the base of the prosthesis and the delivery device can also be disassembled, and then the connecting shaft can be easily withdrawn from the human body to complete the implantation operation.
  • the delivery device of the prosthesis system can safely and reliably adjust the movable parts in the prosthesis to change the state of the prosthesis, making the prosthesis system safer and the surgical operation safer and more reliable.
  • the preset channel in the prosthetic system provided by the embodiment of the present application has a first state and a second state, it cooperates with the control wire to complete relevant surgical operations. That is, when the preset channel is in the first state, the first section and the third section constrain the second section to the preset channel, so that the second section is always in the preset channel and cannot move relative to the preset channel, and then The connection between the first section and the third section and the second section can be made unable to move relative to the preset channel, so as to prevent the first section and the third section from jumping out like in the prior art, and thus avoid the occurrence in the prior art. “The control wire can easily get stuck with other parts of the delivery device or certain organs in the human body,” thereby reducing the risk of surgery.
  • the portion of the preset channel for accommodating the second section has a first size; the first size is smaller than any one of the first section and the third section and the third section.
  • the size of the part where the two sections are connected is greater than or equal to the size of the second section; when the preset channel is in the second state, the part of the preset channel used to accommodate the second section has a second size; the second size is greater than or equal to Equal to the dimensions of the first and/or third segment.
  • the conveying device further includes a central rod; the connecting shaft and/or the base is provided with an accommodating channel arranged axially along the connecting shaft, wherein the accommodating channel intersects with the preset channel, and the accommodating channel coincides with the preset channel.
  • the area is an overlapping area; when the central rod is placed in the accommodation channel and occupies at least part of the overlapping area, the preset channel is in the first state, and the size of the portion used to accommodate the second section in the remaining area of the preset channel is the first size; When the central rod is outside the coincidence area, the preset channel is in the second state, and the size of the portion of the preset channel used to accommodate the second section is the second size.
  • the size of the central rod occupying the overlapping area is a third size
  • the second size is greater than or equal to the sum of the third size and the second segment
  • the second size is smaller than the third size and the first segment and the second segment. The sum of the dimensions of the portions of any of the three segments connected to the second segment.
  • the preset channel is provided on the connecting shaft;
  • the accommodating channel includes a first accommodating section arranged on the connecting shaft, and the area where the first accommodating section coincides with the preset channel is the overlapping area; the central rod is placed in the first accommodating section. segments and occupy at least part of the overlapping area, so that the preset channel is in the first state.
  • the preset channel is provided on the base;
  • the accommodation channel includes a first accommodation section arranged on the connecting shaft, and a second accommodation section arranged on the base, wherein the first accommodation section and the second accommodation section The segments are connected to each other when the base and the connecting shaft are detachably coupled.
  • the area where the second accommodation segment overlaps with the preset channel is the overlap area; the central rod is placed in the first accommodation segment and the second accommodation segment and occupies at least part of the overlap area. , leaving the preset channel in the first state.
  • the preset channel is provided at the coupling point between the connecting shaft and the base; the receiving channel and the preset channel overlap at the coupling point, and form an overlapping area at the overlap point.
  • the central rod when the size of the overlapping area is equal to the second size, the central rod occupies part of the overlapping area; when the size of the overlapping area is smaller than the second size, the central bar occupies at least part of the overlapping area.
  • the preset channel is provided at the coupling between the connecting shaft and the base; when the connecting shaft and the base are coupled, the preset channel is in the first state, and the preset channel is closed; when the connecting shaft and the base are coupled After disassembly, the preset channel is in the second state and is unclosed.
  • the connecting shaft has a first contact surface; the base has a second contact surface matching the first contact surface; the first contact surface is provided with a first through groove, and the second contact surface is provided with a second through groove. ;
  • the connecting shaft and the base are coupled, the first contact surface and the second contact surface cooperate, and the first through groove and the second through groove together form a closed preset channel; after the connecting shaft and the base are disassembled, the first contact surface and the The second contact surfaces are separated from each other, making the preset channel unclosed.
  • the first contact surface includes a first distal blocking surface, a first inclined surface and a first proximal blocking surface arranged in sequence from the distal end to the proximal end.
  • the maximum vertical distance from the edge of the connecting shaft to the first inclined surface varies with the The axial distance between the first inclined surface and the first distal blocking surface becomes larger and smaller;
  • the second contact surface includes a second distal blocking surface arranged sequentially from the distal end to the proximal end, the second inclined surface and the second proximal blocking surface.
  • the maximum vertical distance from the edge of the base to the second inclined surface becomes smaller as the axial distance from the second inclined surface to the second proximal blocking surface becomes larger;
  • the first through groove is arranged on the first inclined surface, and the second through groove corresponds to is disposed on the second slope.
  • the connecting shaft has a first contact surface; the base has a second contact surface matching the first contact surface; the first contact surface or the second contact surface is provided with a third through groove; the connecting shaft and the base When coupling, the first contact surface and the second contact surface The contact surfaces cooperate, and the groove wall of the third through-slot and the opposite part of the other contact surface jointly form a closed preset channel; after the connecting shaft and the base are disassembled, the first contact surface and the second contact surface are separated from each other, so that the preset channel The channel is not closed.
  • the first contact surface includes a third distal blocking surface, a third inclined surface, and a third proximal blocking surface arranged in sequence from the distal end to the proximal end.
  • the maximum vertical distance from the edge of the connecting shaft to the third inclined surface varies with the The axial distance from the third inclined surface to the third distal blocking surface becomes larger and smaller;
  • the second contact surface includes a fourth distal blocking surface, a fourth inclined surface, a transition surface and a fourth distal blocking surface arranged in sequence from the distal end to the proximal end.
  • the proximal blocking surface the maximum vertical distance from the edge of the base to the fourth inclined surface becomes smaller as the axial distance from the fourth inclined surface to the fourth proximal blocking surface becomes larger;
  • the third through-slot is provided on the third inclined surface and is connected with the third inclined surface.
  • the transition surfaces are set correspondingly; when the connecting shaft is coupled to the base, the third through groove and the transition surface jointly form a closed preset channel. After the connecting shaft and the base are disassembled, the third through groove and the transition surface are separated from each other, making the preset channel Let the channel be unclosed.
  • the first contact surface includes a third distal blocking surface, a third inclined surface, a transition surface and a third proximal blocking surface arranged in sequence from the distal end to the proximal end.
  • the maximum length connecting the shaft edge to the third inclined surface is The vertical distance becomes smaller as the axial distance from the third inclined surface to the third distal blocking surface becomes larger;
  • the second contact surface includes a fourth distal blocking surface, a fourth inclined surface and a fourth distal blocking surface arranged in sequence from the far end to the proximal end.
  • the proximal blocking surface the maximum vertical distance from the edge of the base to the fourth inclined surface becomes smaller as the axial distance from the fourth inclined surface to the fourth proximal blocking surface becomes larger;
  • the third through-slot is provided on the fourth inclined surface and is connected with the fourth inclined surface.
  • the transition surfaces are set correspondingly; when the connecting shaft is coupled to the base, the third through groove and the transition surface jointly form a closed preset channel. After the connecting shaft and the base are disassembled, the third through groove and the transition surface are separated from each other, making the preset channel Let the channel be unclosed.
  • the prosthesis further includes a second movable part; the third section is used to independently drive the movement of the second movable part.
  • the prosthesis is a mitral valve clip, or a tricuspid valve clip.
  • the first movable member is a first clamping arm
  • the second movable member is a second clamping arm
  • the first clamping arm and the second clamping arm rotate about an axis of the base
  • the first section is movably connected to the first clamping arm
  • the second section is movably connected to the second clamping arm.
  • Figure 1 is a schematic diagram of the coupling between the distal end of the delivery device and the mitral valve clip provided by an embodiment of the present application;
  • Figure 2 is a schematic structural diagram of the clamping arm of the mitral valve clamp coupled with the delivery device provided by an embodiment of the present application when moving;
  • FIG. 3 is a schematic structural diagram of a control wire provided by an embodiment of the present application.
  • Figure 4 is a partial enlarged view of part a in Figure 3;
  • Figure 5 is a longitudinal cross-sectional view of the control wire, the center rod and the preset channel provided by an embodiment of the present application;
  • Figure 6 is a schematic structural diagram of the cooperation between the center rod and the preset channel provided by an embodiment of the present application.
  • Figure 7 is a longitudinal cross-sectional view of the control wire, the center rod and the preset channel provided by another embodiment of the present application.
  • Figure 8 is a transverse cross-sectional view of the control wire, the center rod and the preset channel provided by an embodiment of the present application;
  • Figure 9 is a transverse cross-sectional view of the control wire, the center rod and the preset channel provided by another embodiment of the present application.
  • Figure 10 is a longitudinal schematic diagram of a connecting shaft and a base that cooperate to form a preset channel according to an embodiment of the present application;
  • Figure 11 is a longitudinal schematic view of a connecting shaft and a base that cooperate to form a preset channel according to another embodiment of the present application;
  • Figure 12 is a longitudinal cross-sectional view of a connecting shaft and a base that cooperate to form a preset channel according to another embodiment of the present application;
  • Figure 13 is a schematic diagram of a mitral valve clamp clamping mitral valve leaflets provided by an embodiment of the present application.
  • Figure 14 is a schematic structural diagram of the clamping arm and the control wire in cooperation with one embodiment of the present application;
  • Figure 15 is a schematic structural diagram of the clamping arm and the control wire in cooperation with another embodiment of the present application.
  • Figure 16 is a schematic structural diagram of a clamping arm and a control wire in cooperation with another embodiment of the present application.
  • proximal end and distal side refer to the end closer to the operator and farther away from the patient; correspondingly, “distal end” and “distal side” refer to the end closer to the patient and farther away from the operator. one end.
  • parallel and perpendicular should not be narrowly understood as 0° or 90°, but should be understood as including 0° or 90° and having a certain degree of floating reasonableness on the premise of achieving technical effects. angle range.
  • the embodiment of the present application provides a prosthesis system, including a delivery device and a prosthesis;
  • the delivery device includes a connecting shaft and a control wire;
  • the prosthesis includes a base and a first movable part, wherein the base and the connecting shaft are detachably coupled;
  • the preset channel is arranged on the connecting shaft and/or the base at an angle to the axis of the connecting shaft;
  • the control wire has a first section, a second section and a third section connected in sequence, and the first section and the third section
  • the size of any one of the parts connected to at least the second section is larger than the size of the second section.
  • the first section is used to independently drive the first movable member to move, and the second section can be accommodated in the preset channel; wherein the preset channel has In the first state and the second state, when the preset channel is in the first state, the first section and the third section constrain the second section to the preset channel; when the preset channel is in the second state, the control wire can communicate with the preset channel.
  • Set up channel separation when the preset channel is in the first state, the first section and the third section constrain the second section to the preset channel; when the preset channel is in the second state, the control wire can communicate with the preset channel.
  • the prosthesis system when performing a minimally invasive implant surgery, puts the preset channel in the first state so that the second section is restricted inside the preset channel through the first and third sections of the control wire, Then, after the connecting shaft transports the prosthesis to the target position in the human body through the natural orifice of the human body and other surgical paths, the movement of the first movable part of the prosthesis can be adjusted by controlling the first section of the wire, so that the state of the prosthesis changes. Change to achieve prosthesis implantation; when the delivery device needs to be separated from the prosthesis, the preset channel is in the second state, and the control wire can be separated from the preset channel in the second state to facilitate the control wire and prosthesis.
  • the connecting shaft between the base of the prosthesis and the delivery device can also be disassembled, and then the connecting shaft can be easily withdrawn from the human body to complete the implantation operation.
  • the delivery device of the prosthesis system can safely and reliably adjust the movable parts in the prosthesis to change the state of the prosthesis, making the prosthesis system safer and the surgical operation safer and more reliable.
  • the first section and the third section constrain the second section to the preset channel, so that the second section is always in the preset channel and cannot move relative to the preset channel, and then The connection between the first segment and the third segment and the second segment cannot be moved relative to the preset channel, so as to prevent the first segment and the third segment from slipping as in the prior art. out of the preset channel, thereby avoiding the technical problem in the prior art that "the control wire is easily jammed with other parts of the delivery device or certain organs in the human body", thus reducing the risk of surgery.
  • a prosthesis system including: a delivery device 100 and a prosthesis; the delivery device 100 includes a connecting shaft 110 and a control wire 120; the prosthesis includes a base 210 and a first movable part , wherein the base 210 and the connecting shaft 110 are detachably coupled; the preset channel 300 is arranged at an angle with the axis of the connecting shaft 110 on the connecting shaft 110 and/or the base 210; the control wire 120 has a of: the first section 121, the second section 122 and the third section 123. The size of any one of the first section 121 and the third section 123 is at least larger than the size of the part connected to the second section 122.
  • One section 121 is used to independently drive the first movable member to move, and the second section 122 is accommodated in the preset channel 300; wherein, the preset channel 300 has a first state and a second state, and when the preset channel 300 is in the first state , the first section 121 and the third section 123 constrain the second section 122 in the preset channel 300; when the preset channel 300 is in the second state, the control wire 120 can be separated from the preset channel 300.
  • the preset channel 300 and the axis of the connecting shaft 110 are arranged at an angle on the connecting shaft 110 and/or the base 210 , which means that the extension direction of the preset channel 300 (ie, the axis of the preset channel 300 ) is between the axis of the connecting shaft 110 and the extension direction of the preset channel 300 .
  • the extending direction of the preset channel 300 and the axis of the connecting shaft 110 are perpendicular to each other.
  • the axis of the connecting shaft 110 is collinear with the axis of the base 210.
  • the preset channel 300 is disposed between the base 210 or the base 210 and the connecting shaft 110 , the axes of the preset channel 300 and the connecting shaft 110 are set at an angle, which means that the axes of the preset channel 300 and the base 210 are set at an angle. .
  • the size of any one of the first section 121 and the third section 123 at least the part connected to the second section 122 is larger than the size of the second section 122 means that the size of the part connected to the first section 121 and the second section 122 is larger than that of the second section 122 .
  • the size of the second section 122 , and the size of the part where the third section 123 is connected to the second section 122 is larger than the size of the second section 122 .
  • the size here refers to the cross-sectional size in its vertical extension direction.
  • the size of the second section 122 is the cross-sectional size of the second section 122 in the direction perpendicular to the extension direction of the second section 122 .
  • the size of the control wire 120 is the diameter of the cross section of the control wire 120 .
  • the size of the second section 122 is the diameter of the second section 122 .
  • the size of the control wire 120 is a size obtained according to specific rules, such as twice the distance from the geometric center of the cross-section to a certain point on the edge of the cross-section.
  • the size of the second segment 122 is the diameter of the circumscribed circle of the second segment 122 .
  • the first section 121 has the same size everywhere
  • the third section 123 has the same size everywhere. That is, the size of other parts of the first section 121 is equal to the size of the part where the first section 121 is connected to the second section 122 , and the size of other parts of the third section 123 is equal to the size of the part where the third section 123 is connected to the second section 122 .
  • the dimensions of the second section 122 may also be the same everywhere.
  • the size of the portion connecting the first section 121 and the second section 122 is larger than the size of the second section 122 , and the size of other parts of the first section 121 is smaller than that of the first section 121 and the second section 122 .
  • the size of the portion of the third section 123 connected to the second section 122 is larger than the size of the second section 122 , and the size of other parts of the third section 123 is smaller than the size of the portion of the third section 123 connected to the second section 122 . Part size.
  • the first movable component is movably disposed on the base 210 .
  • the first movable piece being movably arranged on the base 210 means that the first movable piece is directly movably connected to the base 210, or the first movable piece is movably connected to the base 210 through other components. This application does not limit this.
  • the control wire 120 is made of a material with rigidity and a large elastic modulus, such as medical stainless steel, titanium alloy, etc.
  • the mutual size configuration between the preset channel 300 and the control wire 120 is achieved so that when the preset channel 300 is in the first state, the first section 121 and the third section 123 cannot pass through the preset channel 300 and can only pass through the preset channel 300 .
  • the size of the preset channel 300 in the first state and the size of the preset channel 300 in the second state are different. Specifically, when the preset channel 300 is in the first state, the portion of the preset channel 300 used to accommodate the second section 122 has a first size; the first size is smaller than either of the first section 121 and the third section 123 The size of the part connected to the second section 122 is greater than or equal to the size of the second section 122; when the preset channel 300 is in the second state, the part of the preset channel 300 used to accommodate the second section 122 has the second size. ; The second size is larger than the size of the first section 121 and/or the third section 123.
  • "when the preset channel 300 is in the first state, the portion of the preset channel 300 for accommodating the second section 122 has a first size” means that when the preset channel 300 is in the first state, The cross-sectional size of the portion of the preset channel 300 for receiving the second section 122 of the control wire 120 in a direction perpendicular to the extension direction of the preset channel 300 .
  • "when the preset channel 300 is in the second state, the portion of the preset channel 300 used to accommodate the second section 122 has a second size” means that when the preset channel 300 is in the second state , the cross-sectional size of the portion of the preset channel 300 used to accommodate the second section 122 of the control wire 120 in a direction perpendicular to the extension direction of the preset channel 300 .
  • the first size of the preset channel 300 and the size of the control wire 120 are configured such that the first size is smaller than the size of the portion of any one of the first section 121 and the third section 123 connected to the second section 122, and is greater than or equal to The size of the second segment 122.
  • the size of the second section 122 can be smaller than or equal to the first size so that the second section 122 can be stored in the preset channel 300 in the first state; the size of the portion connecting the first section 121 and the second section 122 is greater than The first size makes it impossible for the first section 121 to pass through the preset channel 300 in the first state; the size of the part connecting the third section 123 and the second section 122 is larger than the first size so that the third section 123 cannot pass through the first state of the preset channel 300, thereby causing the second section 122 accommodated in the preset channel 300 to be constrained within the preset channel.
  • the second size of the preset channel 300 and the size of the control wire 120 are configured such that the second size is greater than or equal to the size of the first section 121 and/or the third section 123 . Therefore, the size of the first section 121 everywhere in its extension direction is smaller than the second size, and/or the size of the third section 123 everywhere in its extension direction is smaller than the second size, so that the control wire 120 can be in the third section. Move in the preset channel 300 in the second state, and then can be separated from the preset channel 300 .
  • the preset channel 300 is configured such that the second section 122 is constrained within the preset channel 300; and when the preset channel 300 is in the second state, the preset channel 300 allows the control wire 120 to detach from the preset channel 300.
  • the length of the second section 122 is the same as the length of the preset channel 300 .
  • the end of any one of the first section 121 and the third section 123 connected to the second section 122 can be disposed adjacent to a port of the preset channel, so that the first section 121 and the third section 123 are respectively stuck in the preset channel.
  • the control wire 120 facilitates precise control of the movable parts of the prosthesis.
  • the preset channel 300 is only used to accommodate the second section 122 .
  • the length of the second section 122 may also be smaller than the length of the predetermined channel 300 .
  • the connection point between at least one of the first section 121 and the third section 123 and the second section 122 can be in the preset channel 300 . That is, the preset channel 300 accommodates both the second section 122 and part of the first section 121 and/or the third section 123 .
  • the delivery device 100 further includes a center rod 130 , and the size of the preset channel 300 can be adjusted by controlling whether the center rod 130 coincides with the preset channel 300 .
  • the connecting shaft 110 and/or the base 210 is provided with an accommodating channel arranged along the axial direction of the connecting shaft 110 , wherein the accommodating channel intersects the preset channel 300 , and the area where the accommodating channel overlaps the preset channel 300 is the overlapping area.
  • the preset channel 300 When the center rod 130 is placed into the receiving channel and occupies at least part of the overlapping area, the preset channel 300 is in the first state, and the size of the portion used to accommodate the second section 122 in the remaining area of the preset channel 300 is the first size; When the central rod 130 is located outside the coincidence area, the preset channel 300 is in the second state, and the size of the portion of the preset channel 300 used to accommodate the second section 122 is the second size. In some embodiments, when the central rod 130 is located at the coupling of the connecting shaft 110 and the base 210 , the connecting shaft 110 and the base 210 remain at least radially relatively stationary.
  • the second size can be made larger than the first size, thereby satisfying the requirement that the first size is smaller than the size of the portion of any one of the first section 121 and the third section 123 connected to the second section 122, and is larger than or equal to the second size.
  • the size of segment 122, as well as the second size, is greater than the size of first segment 121 and/or third segment 123.
  • the preset channel 300 can switch from a first state to a second state. Furthermore, when it is necessary to switch the preset channel 300 from the first state to the second state, the center rod 130 only needs to be located outside the overlapping area.
  • the central rod 130 occupies a third dimension in the overlapping area, the second dimension is greater than or equal to the sum of the third dimension and the second section 122 , and the second dimension is smaller than the third dimension and the first section. 121 and the sum of the dimensions of the portion of any one of the third segment 123 connected to the second segment 122.
  • the preset channel 300 is provided on the connecting shaft 110, and the accommodating channel includes a first accommodating section 410 provided on the connecting shaft 110.
  • the area where the first accommodating section 410 coincides with the preset channel 300 is the overlapping area;
  • the central rod 130 is inserted into the first receiving section 410 and occupies at least part of the overlapping area, so that the preset channel 300 is in the first state.
  • the size of the coincident area is smaller than the second size.
  • the accommodation channel includes a first accommodation section 410 provided on the connecting shaft 110 to accommodate the center rod 130; the preset channel 300 is provided on the connecting shaft 110, and the preset channel 300 A through groove 301 is formed on the inner wall of the connecting shaft 110 , and a first wall hole 302 opposite to the through groove 301 is also formed on the connecting shaft 110 .
  • the first receiving section 410 partially overlaps with the preset channel 300, and the area corresponding to the first wall hole 302 is the overlapping area.
  • the space of the preset channel 300 at least includes the through-channel 301 and the outer surface of the center rod 130.
  • the preset channel 300 is in the second state.
  • the space of the preset channel 300 is defined by the through groove 301 and the first wall hole 302.
  • the through groove 301 and the first wall hole 302 are defined by The limited space is used to accommodate the control wire 120 .
  • the size of the overlapping area is equal to the second size.
  • the receiving channel includes a first receiving section 410 provided on the connecting shaft 110 to receive the central rod 130 ; the preset channel 300 is provided on the connecting shaft 110 .
  • the difference is that the preset channel 300 forms a second wall hole 303 on the connecting shaft 110 that penetrates the connecting shaft 110 .
  • the first accommodation section 410 coincides with the preset channel 300, and the area of the second wall hole 303 is the overlapping area.
  • the size of the central rod 130 is smaller than the size of the first receiving section 410, so the central rod 130 can only occupy a part of the overlapping area.
  • the second wall hole 303 is divided into a first hole wall portion 3032 and a corresponding first hole wall portion 3032 that can occupy the space occupied by the central rod 130.
  • the second hole wall portion 3031 corresponds to the space that cannot be occupied by the center rod 130 .
  • both the first hole wall part 3032 and the second hole wall part 3031 can accommodate the control wire 120, and the space of the preset channel 300 is formed by the first hole wall part 3032 and the second hole wall part 3031.
  • the hole wall portion 3032 and the second hole wall portion 3031 define, ie, the second wall hole 303 .
  • the preset channel 300 may also be provided on the base 210 .
  • the accommodation channel includes a first accommodation section 410 arranged on the connecting shaft 110 and a second accommodation section arranged on the base 210, wherein the first accommodation section 410 and the second accommodation section can be connected between the base 210 and the connecting shaft 110.
  • the coupling is disassembled, they are connected with each other, and the area where the second accommodation section overlaps with the preset channel 300 is the overlapping area.
  • the preset channel 300 is in the first state.
  • the specific implementation manner in which the preset channel 300 is disposed on the base 210 may be the same as the specific implementation manner in which the preset channel 300 is disposed on the connecting shaft 110 in the above embodiment, and will not be described again.
  • the preset channel 300 may also be provided at the coupling between the connecting shaft 110 and the base 210 .
  • the accommodation channel and the preset channel 300 overlap at the coupling point between the connecting shaft 110 and the base 210, and form an overlapping area at the overlap point.
  • the central rod 130 is placed in the receiving channel and extends to the coupling point of the connecting shaft 110 and the base 210 and occupies at least part of the overlapping area, so that the preset channel 300 is in the first state.
  • the cross-sectional shape of the preset channel 300 in the first state is different from the cross-sectional shape of the preset channel 300 in the second state.
  • the preset channel 300 is provided at the coupling between the connecting shaft 110 and the base 210; when the connecting shaft 110 and the base 210 are coupled, the preset channel 300 is in the first state, and the preset channel 300 is closed, and the preset channel 300 is closed.
  • the size of the channel 300 matches the second section 122 to constrain the control wire 120; when the connecting shaft 110 and the base 210 are disassembled, the preset channel 300 is in the second state, and the preset channel 300 is non-closed, that is, preset It is assumed that the channel 300 has a notch through which the second section 122 can be released.
  • the first section 121 and the third section 123 can not pass through the preset channel 300, and the second section 122 is restricted within the preset channel 300;
  • the second section 122 can be separated from the preset channel 300 from the gap of the preset channel 300, so that the control wire 120 can be separated from the preset channel 300.
  • the preset channel 300 is closed means that the shape of the preset channel 300 is closed in its cross section; the preset channel 300 is non-closed means that the preset channel 300 is closed in its cross section. The shape is divided into non-closed parts.
  • the connecting shaft 110 has a first contact surface 111; the base 210 has a second contact surface 211 matching the first contact surface 111; the first contact surface 111 is provided with a first through groove 112, and the second The contact surface 211 is provided with a second through groove 212; when the connecting shaft 110 is coupled to the base 210, the first contact surface 111 and the second contact surface 211 cooperate, and the first through groove 112 and the second through groove 212 together form a closed Preset channel 300; after the connecting shaft 110 and the base 210 are disassembled, the first contact surface 111 and the second contact surface 211 are separated from each other, so that the preset channel 300 is not closed.
  • the first contact surface 111 includes a first distal blocking surface 1111, a first inclined surface 1112 and a first proximal blocking surface 1113 arranged in sequence from the distal end to the proximal end; the second contact surface 211 It includes a second distal blocking surface 2111, a second inclined surface 2112 and a second proximal blocking surface 2113 arranged in sequence from the distal end to the proximal end.
  • the first distal blocking surface 1111 can fit with the second distal blocking surface 2111 .
  • the first proximal blocking surface 1113 can fit with the second proximal blocking surface 2113 .
  • the first inclined surface 1112 may at least partially fit with the second inclined surface 2112 .
  • the maximum vertical distance h1 from the edge of the connecting shaft 110 to the first inclined surface 1112 becomes smaller as the axial distance from the first inclined surface 1112 to the first distal blocking surface 1111 becomes larger (that is, the first inclined surface 1112 is configured from the first inclined surface 1112 1112 to the proximal end of the first slope 1112, the maximum vertical distance h1 from the edge of the connecting shaft 110 to the first slope 1112 gradually decreases); the maximum vertical distance h2 from the edge of the base 210 to the second slope 2112 increases with the The axial distance between the second inclined surface 2112 and the second proximal blocking surface 2113 becomes larger and smaller (that is, the second inclined surface 2112 is configured from the proximal end of the second inclined surface 2112 to the distal end of the second inclined surface 2112.
  • the base 210 The maximum vertical distance h2 from the edge to the second slope 2112 gradually decreases).
  • the maximum vertical distance from the edge of the connecting axis 110 to the first inclined surface 1112 refers to the maximum of all vertical distances on the same cross section between each point on the edge of the connecting axis 110 and the intersection line formed by the intersection of the first inclined surface 1112 and the cross section. vertical distance.
  • the maximum vertical distance from the edge of the base 210 to the second slope 2112 refers to the largest of all vertical distances on the same cross section between each point on the edge of the base 210 and the intersection line formed by the intersection of the second slope 2112 and the cross section. vertical distance.
  • the contact portion of the second contact surface 211 and the first contact surface 111 enables the connecting shaft 110 to be constrained in the radial direction of the connecting shaft 110 relative to the base 210 when the connecting shaft 110 moves axially away from the base 210 . move. Therefore, the constraint connection shaft 110 can be moved along its axial direction relative to the base 210, which can be converted into only needing to constrain the connection shaft 110 to move along its radial direction relative to the base 210, which facilitates the realization of the connection between the connection shaft 110 and the base 210. coupling between. In conjunction with the above embodiments, coupling between the connecting shaft 110 and the base 210 can be achieved by using the central rod 130 to keep the connecting shaft 110 and the base 210 at least radially relatively stationary.
  • first through-slot 112 is provided on the first slope 1112 close to the first proximal blocking surface 1113 .
  • the second through groove 212 is provided on the second inclined surface 2112 close to the second proximal end blocking surface 2113.
  • the first through-slot 112 includes a first slot wall and a first slot opening.
  • the second through-slot 212 includes a second slot wall and a second slot opening.
  • the second section 122 may be disengaged from the first channel 112 and/or may be disengaged from the second channel 212 .
  • Both the first groove wall and the second groove wall have arc-shaped cross sections. Further, the cross-sections of the first groove wall and the second groove wall are arc-shaped.
  • the first distal blocking surface 1111 and the second distal blocking surface 2111 are in contact with each other, the first inclined surface 1112 and the second inclined surface 2112 are in contact with each other, and the first proximal end blocking surface 1113 and the second distal blocking surface 1113 are in contact with each other.
  • Two proximal blocking surfaces 2113 fit.
  • the first through groove 112 and the second through groove 212 form a preset channel 300 in a closed state.
  • the first groove wall of the first through groove 112 and the second groove of the second through groove 212 The walls constitute the side walls of the preset channel 300 in the closed state.
  • the connecting shaft 110 and the base 210 are disassembled, the first through groove 112 and the second through groove 212 are separated, so that the first notch of the first through groove 112 and the second notch of the second through groove 212 are no longer in contact with each other.
  • the first groove wall of the first through groove 112 constituting the side wall of the preset channel 300 is separated from the second groove wall of the second through groove 212, so that the preset channel 300 is in an unclosed state.
  • the second section 122 may be separate from the preset channel 300 .
  • the connecting shaft 110 has a first contact surface 111; the base 210 has a second contact surface 211 matching the first contact surface 111; the first contact surface 111 or the second contact surface 211 is provided with a third contact surface 111.
  • Three-way groove 113 when the connecting shaft 110 is coupled with the base 210, the first contact surface 111 and the part of the second contact surface 211 fit together, and the groove wall of the third through-slot 113 and the opposite part of the other contact surface jointly surround A closed preset channel 300 is formed; after the connecting shaft 110 and the base 210 are disassembled, the first contact surface 111 and the second contact surface 211 are separated from each other, making the preset channel 300 non-closed.
  • the difference from the above embodiment is that the first contact surface 111 or the second contact surface 211 is provided with a through groove.
  • the first contact surface 111 includes a third distal blocking surface 1114, a third inclined surface 1115 and a third proximal blocking surface 1116 arranged in sequence from the distal end to the proximal end;
  • the second contact surface 211 It includes a fourth distal blocking surface 2114, a fourth inclined surface 2115, a transition surface 2117 and a fourth proximal blocking surface 2116 arranged in sequence from the distal end to the proximal end. That is, the transition surface 2117 is provided between the fourth inclined surface 2115 and the fourth proximal blocking surface 2116.
  • the third distal blocking surface 1114 may be aligned with the fourth distal blocking surface 2114 .
  • the third proximal blocking surface 1116 may be aligned with the fourth proximal blocking surface 2116 .
  • the third inclined surface 1115 may at least partially fit with the fourth inclined surface 2115 .
  • the maximum vertical distance h3 from the edge of the connecting shaft 110 to the third inclined surface 1115 becomes smaller as the axial distance from the third inclined surface 1115 to the third distal blocking surface 1114 becomes larger (that is, the third inclined surface 1115 is configured from the third inclined surface 1115 to the third inclined surface 1114. 1115 to the proximal end of the third slope 1115, the maximum vertical distance h3 from the edge of the connecting shaft 110 to the third slope 1115 gradually decreases).
  • the maximum vertical distance h4 from the edge of the base 210 to the fourth inclined surface 2115 becomes smaller as the axial distance from the fourth inclined surface 2115 to the fourth proximal blocking surface 2116 becomes larger (that is, the fourth inclined surface 2115 is configured from the fourth inclined surface 2115 to the fourth inclined surface 2116.
  • the maximum vertical distance h4 from the proximal end of 2115 to the distal end of the fourth inclined surface 2115 and the edge of the base 210 to the fourth inclined surface 2115 gradually decreases).
  • the third through groove 113 is provided on the third slope 1115 close to the third proximal end blocking surface 1114, corresponding to the transition surface 2117.
  • the third through-slot 113 includes a third slot wall and a third slot opening.
  • the second section 122 can be separated from the third slot 113 from the third slot.
  • the cross section of the third groove wall is arc-shaped. Further, the cross section of the third groove wall is arc-shaped.
  • the third groove wall of the third through groove 113 and the transition surface 2117 form the side walls of the preset channel 300 in a closed state.
  • the connecting shaft 110 and the base 210 are disassembled, the third through groove 113 is separated from the transition surface 2117, so that the third notch of the third through groove 113 no longer fits the transition surface 2117, forming a side of the preset channel 300.
  • the third groove wall of the third channel 113 of the wall is separated from the transition surface 2117 , whereby the channel 300 is preset to be non-closed.
  • the second segment 122 may be separate from the preset channel 300 .
  • the transition surface 2117 in FIG. 11 may also be provided on the first contact surface 111 , such as between the third inclined surface 1115 and the third proximal blocking surface 1116 .
  • the third through groove 113 can also be provided on the second contact surface 211, such as between the fourth inclined surface 2115 and the fourth proximal blocking surface 2116. That is, the positions of the transition surface 2117 and the third through groove 113 in FIG. 11 can be exchanged, and the exchanged transition surface and the third through groove are arranged correspondingly.
  • the connecting shaft 110 is coupled with the base 210
  • the fourth through groove and the transition surface form the preset channel 300 in a closed state.
  • the connecting shaft 110 and the base 210 are disassembled, the fourth through groove is separated from the transition surface, and the preset channel 300 is formed. Channel 300 is not closed.
  • the connecting shaft 110 includes a first coupling portion 114 and the base 210 includes a second coupling portion 213.
  • the first coupling portion 114 or the second coupling portion 213 is arranged axially offset.
  • the first coupling portion When the first coupling portion When the first coupling part 114 or the second coupling part 213 is driven to be arranged in the axial direction, the first coupling part 114 and the second coupling part 213 are coupled, and the first contact surface 115 is located on the side of the first coupling part 114 facing the second coupling part 213,
  • the second contact surface 214 is located on the side of the second coupling part 213 facing the first coupling part 114 .
  • the through grooves constituting the preset channel 300 there may be two through grooves constituting the preset channel 300, which are respectively provided on the first contact surface 115 and the second contact surface 214; the through grooves constituting the preset channel 300 are also There may be one, which is provided on the first contact surface 115 or the second contact surface 214 .
  • one of the first coupling part 114 and the second coupling part 214 includes a protrusion 116 and the other includes a groove 215; wherein the first coupling part 114 or the second coupling part 213 is arranged axially offset, so as to The protrusion 116 is separated from the groove 215; when the first coupling part 114 or the second coupling part 213 is driven to be arranged in the axial direction, the protrusion 116 is received in the groove 215.
  • the through groove constituting the preset channel 300 is one and is provided on the first contact surface 115 for description.
  • the first coupling part 114 further includes an inwardly biased support member 117 and a fifth through-slot 118 .
  • the protrusion 116 is located at the distal end of the support member 117 and is perpendicular to the support member 117 Extending in the axial direction, the fifth through groove 118 is provided on the support member 117, and the fifth through groove 118 includes a fifth groove opening and a fifth groove wall; the groove 215 is provided on the inner wall of the base 210; the conveying device 100 also includes The central rod 130 is movably disposed in the connecting shaft 110.
  • the central rod 130 moves distally and passes through the first coupling part 114 and the second coupling part 213.
  • the two coupling portions 213 are configured so that the support member 114 is driven to deflect until the axis of the support member 114 is parallel to the axis of the connecting shaft 110, and the protrusion 116 is accommodated in the groove 215.
  • the fifth through groove 118 and the inner wall of the second coupling part 213 form a closed preset channel 300, that is, the fifth groove 118 is attached to the inner wall of the second coupling part 213, and the fifth groove wall 118 and the second coupling part 213
  • the inner wall of the portion 213 forms the side wall of the preset channel 300 .
  • the prosthesis includes one movable part, namely a first movable part.
  • the "change in state” can be a change in the structure, size, or shape of the entire or part of the prosthesis.
  • a prosthesis changes from a compressed state to an expanded state, such as a stent graft used to treat aortic stenosis.
  • a binding wire i.e., the first movable member is used to bind the stent graft in the compressed state during the delivery process.
  • the binding wire is pulled away from the stent graft through the control wire, so that the stent graft changes from a compressed state to an expanded state.
  • the "change of state” here can also be the realization of an unlocking state or a locking state between the prosthesis and the target tissue, between the prosthesis and the delivery system, or between the internal components of the prosthesis, and/or between the locking state and the unlocking state. mutual transformation between. For example, when delivering the left atrial appendage occluder, the control wire and the left atrial appendage occluder are in a locked state.
  • the "change in state” may also be a change in the position and/or posture of the entire prosthesis or part (eg, the first movable part).
  • a mitral valve clamp used to treat mitral valve regurgitation uses a control wire to control the relative rotation of the clamping arms (ie, the first movable member) in the mitral valve clamp to clamp the mitral valve leaflets.
  • the prosthesis includes two movable parts, namely a first movable part and a second movable part, the movement of the first movable part is controlled by the first section 121 , and the movement of the second movable part is controlled by the third section 123 , to realize the change of prosthesis status.
  • the preset channel 300 can be in the second state, so that the control wire 120 can be detached from the preset channel 300, so as to facilitate the extraction of the control wire 120 from the human body and the control wire 120. 120 is separated from the prosthesis.
  • one control wire 120 can be used to control the movement of the two movable parts (ie, the first movable part and the second movable part) of the prosthesis.
  • the prosthesis is a mitral valve clip 200 for treating mitral regurgitation. It should be emphasized that the prosthesis here being the mitral valve clip 200 is only an example. In other embodiments, the prosthesis may not be the mitral valve clip 200 . This application does not limit the specific type of the prosthesis.
  • the mitral valve clamp 200 includes a base 210, a clamping arm (ie, a movable part), and a clamping seat.
  • 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
  • the clamping seat is located at the distal end of the base 210 .
  • the clamping arm includes a first clamping arm 220 (ie, the first movable member) and a second clamping arm 230 (ie, the second movable member), both of which are arranged symmetrically about the axis of the base 210 .
  • first movable component here is the first clamping arm 220 and the second movable component is the second clamping arm 230.
  • first movable member may not be the first clamping arm 220
  • second movable member may not be the second clamping arm 230 .
  • This application describes the first movable member and the second movable member. The specific type is not limited.
  • the clamping base includes a first clamping base 240 and a second clamping base 250 , which are symmetrically arranged about the axis of the base 210 and located in the plane where the first clamping arm 220 and the second clamping arm 230 are located. on, to better clamp the edges of the anterior and posterior leaflets of the mitral valve 400.
  • 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 are located on the plane where the first clamping arm 220 and the second clamping arm 230 are located” means that the axes of the first clamping seat 240 and the second clamping seat 250 are both located on the first clamping arm 220 and the second clamping arm 230.
  • the rotation of the clamping arm and the clamping seat is driven to clamp the front and rear leaflets of the mitral valve 400 between the clamping arm and the clamping seat.
  • the replacement of a mitral valve clamp with a tricuspid valve clamp to treat tricuspid regurgitation is also applicable.
  • the first clamping arm 220 and the second clamping arm 230 are both sheet-shaped, and the first clamping arm 220 and the second clamping arm 230 pass through a transition portion. 102 elastic connection. Further, the transition portion 102 is provided at the distal end of the base 210 . Furthermore, the first clamping arm 220 , the transition portion 102 and the second clamping arm 230 are integrally formed to form a similar inverted ⁇ shape. And the first clamping arm 220 and the second clamping arm 230 are in an extended state in a natural state. As shown in FIG. 2 , when the first section 121 is pulled, the first clamping arm 220 is driven to rotate upward and toward the base 210 .
  • the first clamping arm 220 undergoes elastic deformation.
  • the first clamping arm 220 rotates away from the base 210 and returns to its original state.
  • the third section 123 is pulled, the second clamping arm 230 is driven to rotate upward and toward the base 210 , and the second clamping arm 230 undergoes elastic deformation.
  • the third section 123 is no longer pulled, the second clamping arm 230 rotates away from the base 210 and returns to its original state.
  • both the first clamping seat 240 and the second clamping seat 250 are rotatably connected to the base 210 . Furthermore, the first clamping seat 240 and the second clamping seat 250 are rotatably connected to the base 210 through the same rotating shaft.
  • the cross-sectional shape of the first clamping seat 240 perpendicular to the axis direction is U-shaped to better wrap the first mitral valve leaflet edge 401 with the first clamping arm 220 .
  • the cross-sectional shape of the second clamping seat 250 perpendicular to the axis direction is U-shaped to better wrap the second mitral valve leaflet edge 402 with the second clamping arm 230 .
  • the first clamping seat 240 and the second clamping seat 250 are driven to rotate and squeeze the first clamping arm 220 and the second clamping arm 230 respectively.
  • the edges of the mitral valve leaflets realize the clamping of the mitral valve leaflets by the mitral valve clip 200.
  • the first section 121 controls the movement of the first movable component and the third section 123 controls the movement of the second movable component.
  • the first section 121 is movably connected to the first clamping arm 220.
  • the first clamping arm 220 can rotate along with the movement of the first section 121; on the other hand, when the delivery device 100 needs to be separated from the mitral valve clamp 200, the control wire 120 can engage with the first clamping arm 220. Detachment of arm 220.
  • the relationship between the third section 123 and the second clamping arm 230 is the same and will not be described again.
  • the first section 121 extends distally from the preset channel 300 , and after extending to the position where the first clamping arm 220 is located, the delivery device 100 is reversed. Proximal extension. In this way, the first section 121 will form a curved portion at the position where the first clamping arm 220 is located, and the curved portion interpenetrates the first clamping arm 220 or an accessory provided on the first clamping arm 220 to facilitate control. The rotation of the first clamping arm 220 is controlled.
  • both the second section 122 and the third section 123 are configured to be detachable from the first clamping arm 220 . In this way, when the control wire 120 needs to be pulled away from the first clamping arm 220, it can be ensured that the third section 123 and the second section 122 can be pulled away from the first clamping arm 220.
  • the connection point between the third section 123 and the second section 122 is a first transition portion 124 , and the cross-sectional area of the first transition portion 124 in the direction from the second section 122 to the third section 123 gradually increases. big.
  • the third section 123 can also be connected to at least the second section 122
  • the size at the position is larger than the first size, so that the third section 123 cannot pass through the preset channel 300 in the first state, and the connection between the second section 122 and the third section 123 is the first transition portion 124 with a smooth transition. , so that there is no obvious bulge at the connection point between the second section 122 and the third section 123 .
  • the control wire 120 when the control wire 120 is retracted and the entire control wire 120 is pulled away from the first clamping arm 220, the second section 122 and the third section 123 can be smoothly and sequentially removed from the first clamping arm 220.
  • the first clamping arm 220 is pulled away to avoid affecting the attitude and/or position of the first clamping arm 220 .
  • the control wire 120 when the control wire 120 is withdrawn, the control wire 120 can be prevented from getting stuck on other components of the prosthetic system, and the control wire 120 can also be prevented from being worn, thereby causing the control wire 120 to be prevented from being worn. The possibility of breakage of the control wire 120 is reduced.
  • the above-mentioned accessory is a fixed wire 223, and the fixed wire 223 is bundled, tied A knot or the like is provided on the first clamping arm 220 , and the fixing wire 223 forms a body 226 for interpenetrating with the curved portion of the first section 121 .
  • the body 226 is annular to form a first through hole for interpenetrating with the above-mentioned curved portion.
  • the fixing wire 223 also has a fixing knot 225 connected to the body 226.
  • the fixing knot 225 is provided on the first clamping arm 220. That is, the fixed line 223 forms a knot-like structure.
  • the curved portion of the first section 121 passes through the first through hole to interpenetrate with the body 226 .
  • first clamping arm 220 is provided with a second through hole 224 on its surface, the body 226 passes through the second through hole 224 from the side of the first clamping arm 220 away from the base 210, and the fixing knot 225 is provided on the first clamping arm 220.
  • the clamping arm 220 is away from the side of the base 210 , and the fixing knot 225 is configured so as not to pass through the second through hole 224 .
  • the fixing knot 225 of the fixing wire 223 is wrapped around the second through hole 224 to be fixedly connected with the first clamping arm 220 .
  • the first clamping arm 220 is provided with two third through holes 221, and one end of the first section 121 away from the second section 122 (ie, one end of the curved portion) is connected from the first clamping arm 220.
  • the side of the clamping arm 220 away from the first clamping base 240 passes through a third through hole 221, and then the side of the first clamping arm 220 close to the first clamping base 240 passes through another third through hole 221. .
  • the curved portion of the first section 121 and the first clamping arm 220 can interpenetrate.
  • the first clamping arm 220 is provided with more than two even numbers of third through holes 221 , and one end of the first section 121 away from the second section 122 (ie, one end of the curved portion) alternately passes through these third through holes 221 . Through hole 221. In this way, the curved portion of the first section 121 and the first clamping arm 220 can also interpenetrate.
  • the first clamping arm 220 is provided with a protrusion 101
  • the protrusion 101 on the first clamping arm 220 is provided with a fourth through hole 227
  • the first section 121 is away from the third One end of the second section 122 (ie, one end of the curved portion) passes through the fourth through hole 227 .
  • the curved portion of the first section 121 and the first clamping arm 220 can also interpenetrate.
  • the extending direction of the fourth through hole 227 is in the same direction as the extending direction of the first clamping arm 220 .
  • connection method between the third section 123 and the second clamping arm 230 can refer to the above-mentioned connection method between the first section 121 and the first clamping arm 220, which will not be described again here.
  • connection point between the first section 121 and the second section 122 may be a second transition part 125 that has the same function as the first transition part 124, which will not be described again here.
  • both the first section 121 and the second section 122 can also be configured to be detachable from the second clamping arm 230 . In this way, when the control wire 120 needs to be pulled away from the second clamping arm 230, it can be ensured that the first section 121 and the second section 122 can be pulled away from the second clamping arm 230.
  • the mitral valve clamp 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 link 261 , a second link 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.
  • the slider 263 can move axially relative to the base 210. Therefore, the first connecting rod 261, the first clamping seat 240, the base 210 and the slider 263 form a kinematic 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 A kinematic mechanism similar to the crank-slider mechanism is also formed. When the slider 263 is driven toward or 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 base 210 is a hollow structure, and the vertical part of the slider 263 is movably received in the base 210 .
  • Both ends of the horizontal part of the slider 263 are rotatably connected to the first link 261 and the second link 262 respectively, 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 to move through the center rod 130, so that the first clamping seat 240 and the second clamping seat 250 rotate.
  • first connecting rod 261 and the second connecting rod 262 are arranged symmetrically with respect to 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 and the rotation angle of the second clamping seat 250 are the same.
  • the delivery device 100 further includes: a conduit 140 sleeved on the connecting shaft 110 , the conduit 140 is provided with two second channels extending axially along the conduit 140 ; the first section 121 is away from the second section 122 One end passes through the second channel from the distal end of a second channel and extends to the proximal end of the second channel. The end of the third section 123 away from the second section 122 passes through the second channel from the distal end of the other second channel and extends to The second channel is proximal.
  • any other suitable method can also be used, such as the methods shown in Figures 5A and 5B of the description in US Patent Document US20210145574A1, and Figures 6A and 5B of the description in US Patent Document US20210145574A1.
  • the method of 6B can also be the method of Figures 82A and 82B of the description in the Chinese patent document CN102395331B, or the method of Figure 84 of the description of the Chinese patent document CN102395331B, etc.
  • some other embodiments of the present application also provide a delivery device 100 for delivering a prosthesis.
  • the prosthesis includes a base 210 and a first movable part.
  • the delivery device 100 includes a connecting shaft 110 and a control unit. Wire 120; the connecting shaft 110 and the base 210 are detachably coupled; the preset channel 300 is arranged at an angle to the axis of the connecting shaft 110, or the preset channel 300 and the axis of the connecting shaft 110 are arranged at an angle.
  • the angle is set between the connecting shaft 110 and the base 210; the control wire 120 has a first section 121, a second section 122 and a third section 123 connected in sequence, and any one of the first section 121 and the third section 123 is at least
  • the size of the part connected to the second section 122 is larger than the size of the second section 122.
  • the first section 121 is used to independently drive the first movable member to move.
  • the second section 122 is accommodated in the preset channel 300; wherein, the preset channel 300 Having a first state and a second state, when the preset channel 300 is in the first state, the first section 121 and the third section 123 constrain the second section 122 in the preset channel 300; when the preset channel 300 is in the third state In the second state, the control wire 120 can be separated from the preset channel 300.
  • the conveying device 100 provided in this embodiment is the same as the partial conveying device 100 provided in the other embodiments mentioned above (the partial conveying device 100 here refers to the conveying device 100 including the connecting shaft 110 with a preset channel, or Bag
  • the conveying device 100 (containing a preset channel between the connecting shaft 110 and the base 210) has the same structure and beneficial effects, which will not be described again here.

Landscapes

  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Engineering & Computer Science (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,包括输送装置(100)和假体。输送装置(100)包括连接轴(110)和控制丝(120)。假体包括基座(210)和第一活动件。预设通道(300)设置于连接轴(110)和/或基座(210);控制丝(120)具有依次相连的:第一段(121)、第二段(122)以及第三段(123),第一段(121)和第三段(123)中任一者至少与第二段(122)连接的部分的尺寸大于第二段(122)的尺寸,第二段(122)容纳于预设通道(300)。预设通道(300)处于第一状态时,第一段(121)与第三段(123)使第二段(122)约束于预设通道(300);预设通道(300)处于第二状态时,控制丝(120)可与预设通道(300)分离。本申请提供的假体系统,使得输送装置(100)能够安全可靠地调整假体中的活动件,降低手术风险。

Description

一种假体系统及输送装置
交叉引用
本申请基于申请号为“2022110574844”、申请日为2022年08月29日的中国专利申请提出,并要求该中国专利申请的优先权,该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
本申请涉及医疗器件技术领域,特别涉及一种假体系统及输送装置。
背景技术
随着科学技术的发展进步,微创手术已深入到外科的各种领域。由于微创手术具有创伤小、疼痛轻、恢复快的优越性,使得微创手术的收到广大患者的欢迎。
现有的微创手术多采用输送装置通过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,之后利用与假体活动连接的控制丝来调整假体的状态,最终通过植入人体内的假体来实现手术的目的。
美国专利文献US20210145574A1公开了一种用于实施微创手术的方式。在美国专利文献US20210145574A1中,控制丝的一端具有凸点、另一端穿过输送装置的连接轴并与假体活动连接后再延伸至输送装置的近端。此时,凸点通过输送装置的连接轴与中心杆的配置被限制为在控制丝延伸的方向上无法穿过连接轴,从而使得操作者可在输送装置近端对控制丝中远离其凸起的一端进行操作以调整假体的状态。
然而,此种方式在实施手术的过程中,控制丝的凸点容易沿控制丝延伸的方向相反的方向窜出连接轴,从而使得控制丝易与输送装置的其他零部件或人体内的某些器官卡塞,继而增大了手术风险。
发明内容
本申请的目的在于提供一种假体系统及输送装置,在输送装置能够安全可靠地调整 假体中的活动件的情况下,降低手术风险。
为解决上述问题,本申请实施方式提供一种假体系统,包括输送装置和假体;输送装置包括连接轴和控制丝;假体包括基座和第一活动件,其中,基座与连接轴可拆卸的耦合;预设通道,预设通道与连接轴轴线呈角度设置于连接轴和/或基座;控制丝具有依次相连的:第一段、第二段以及第三段,第一段和第三段中任一者至少与第二段连接的部分的尺寸大于第二段的尺寸,第一段用于独立地驱动第一活动件运动,第二段容纳于预设通道;其中,预设通道具有第一状态和第二状态,当预设通道处于第一状态时,第一段与第三段使第二段约束于预设通道;当预设通道处于第二状态时,控制丝可与预设通道分离。
本申请实施方式还提供一种输送装置,用于输送假体,假体包括基座和第一活动件;输送装置包括连接轴和控制丝;连接轴与基座可拆卸的耦合;预设通道,预设通道与连接轴轴线呈角度设置于连接轴,或者预设通道与连接轴轴线呈角度设置于连接轴和基座之间;控制丝具有依次相连的:第一段、第二段以及第三段,第一段和第三段中任一者至少与第二段连接的部分的尺寸大于第二段的尺寸,第一段用于独立地驱动第一活动件运动,第二段容纳于预设通道;其中,预设通道具有第一状态和第二状态,当预设通道处于第一状态时,第一段与第三段使第二段约束于预设通道;当预设通道处于第二状态时,控制丝可与预设通道分离。
本申请实施方式提供的假体系统和输送装置,在实施微创植入手术时,使得预设通道处于第一状态以通过控制丝的第一段与第三段使第二段约束在预设通道内部,继而在连接轴将假体经由人体自然腔道等手术路径输送至人体内的目标位置后,可通过控制丝的第一段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,以实现假体植入;当需要将输送装置和假体分离时,使得预设通道处于第二状态,在第二状态下,控制丝可与预设通道分离,以便于控制丝与假体分离,进而从人体内抽出控制丝。此时,还可使得假体的基座与输送装置的连接轴拆卸,继而便于将连接轴从人体中撤回,以完成植入手术。如此,假体系统的输送装置能够安全可靠地调整假体中的活动件,实现假体状态的改变,使得假体系统能够更加安全,使得手术操作更加安全可靠。
同时,由于本申请实施方式提供的假体系统中的预设通道具有第一状态和第二状态,来配合控制丝完成相关手术操作。即,在预设通道处于第一状态时,第一段与第三段使第二段约束于预设通道,从而使得第二段一直处于预设通道内而无法相对于预设通道移动,继而可使得第一段以及第三段与第二段的相连处无法相对于预设通道移动,以避免第一段以及第三段会像在先技术中窜出,继而避免出现在先技术中的“控制丝易与输送装置的其他零部件或人体内的某些器官卡塞”,从而降低手术风险。
在一些实施例中,当预设通道处于第一状态时,预设通道中用于容纳第二段的部分具有第一尺寸;第一尺寸小于第一段和第三段中任一者与第二段相连的部分的尺寸,且大于或等于第二段的尺寸;当预设通道处于第二状态时,预设通道中用于容纳第二段的部分具有第二尺寸;第二尺寸大于或等于第一段和/或第三段的尺寸。
在一些实施例中,输送装置还包括中心杆;连接轴和/或基座设有沿连接轴轴向布置的容纳道,其中,容纳道与预设通道相交,容纳道与预设通道重合的区域为重合区域;当中心杆置入容纳道并占据至少部分重合区域时,预设通道处于第一状态,预设通道剩余部分区域中用于容纳第二段的部分的尺寸为第一尺寸;当中心杆在重合区域外部时,预设通道处于第二状态,预设通道中用于容纳第二段的部分的尺寸为第二尺寸。
在一些实施例中,中心杆占据重合区域的尺寸为第三尺寸,第二尺寸大于或等于第三尺寸与第二段的尺寸之和,且第二尺寸小于第三尺寸与第一段和第三段中任一者与第二段相连的部分的尺寸之和。
在一些实施例中,预设通道设置于连接轴;容纳道包括设置在连接轴上的第一容纳段,第一容纳段与预设通道重合的区域为重合区域;中心杆置入第一容纳段并占据至少部分重合区域,而使预设通道处于第一状态。
在一些实施例中,预设通道设置于基座;容纳道包括设置在连接轴上的第一容纳段,以及设置在基座上的第二容纳段,其中,第一容纳段与第二容纳段在基座与连接轴可拆卸的耦合时相互连通,第二容纳段与预设通道重合的区域为重合区域;中心杆置入第一容纳段以及第二容纳段内并占据至少部分重合区域,而使预设通道处于第一状态。
在一些实施例中,预设通道设置于连接轴与基座的耦合处;容纳道与预设通道在耦合处重合,并在重合处形成重合区域。
在一些实施例中,当重合区域的尺寸等于第二尺寸时,中心杆占据部分重合区域;当重合区域的尺寸小于第二尺寸时,中心杆占据至少部分重合区域。
在一些实施例中,预设通道设置于连接轴和基座的耦合处;当连接轴和基座耦合时,预设通道处于第一状态,预设通道为闭合的;当连接轴和基座拆卸后,预设通道处于第二状态,预设通道为非闭合的。
在一些实施例中,连接轴具有第一接触面;基座具有与第一接触面相匹配的第二接触面;第一接触面设有第一通槽,第二接触面设有第二通槽;连接轴与基座耦合时,第一接触面与第二接触面相配合,第一通槽与第二通槽共同形成闭合的预设通道;连接轴与基座拆卸后,第一接触面与第二接触面相互分离,使预设通道为非闭合的。
在一些实施例中,第一接触面包括由远端到近端依次设置的第一远端阻挡面,第一斜面和第一近端阻挡面,连接轴边缘到第一斜面的最大垂直距离随第一斜面到第一远端阻挡面的轴向距离变大而变小;第二接触面包括由远端到近端依次设置的第二远端阻挡面,第二斜面和第二近端阻挡面,基座边缘到第二斜面的最大垂直距离随第二斜面到第二近端阻挡面的轴向距离变大而变小;第一通槽设置在第一斜面上,第二通槽对应地设置在第二斜面上,当连接轴与基座耦合时,第一通槽和第二通槽共同形成闭合的预设通道,连接轴与基座拆卸后,第一通槽和第二通槽相互分离,使预设通道为非闭合的。
在一些实施例中,连接轴具有第一接触面;基座具有与第一接触面相匹配的第二接触面;第一接触面或第二接触面设有第三通槽;连接轴与基座耦合时,第一接触面与第二接 触面相配合,第三通槽的槽壁与另一接触面相对的部分共同形成闭合的预设通道;连接轴与基座拆卸后,第一接触面与第二接触面相互分离,使预设通道为非闭合的。
在一些实施例中,第一接触面包括由远端到近端依次设置的第三远端阻挡面、第三斜面和第三近端阻挡面,连接轴边缘到第三斜面的最大垂直距离随第三斜面到第三远端阻挡面的轴向距离变大而变小;第二接触面包括由远端到近端依次设置的第四远端阻挡面、第四斜面、过渡面和第四近端阻挡面,基座边缘到第四斜面的最大垂直距离随第四斜面到第四近端阻挡面的轴向距离变大而变小;第三通槽设置在第三斜面上,并与过渡面对应设置;当连接轴与基座耦合时,第三通槽和过渡面共同形成闭合的预设通道,连接轴与基座拆卸后,第三通槽和过渡面相互分离,使预设通道为非闭合的。
在一些实施例中,第一接触面包括由远端到近端依次设置的第三远端阻挡面、第三斜面、过渡面和第三近端阻挡面,连接轴边缘到第三斜面的最大垂直距离随第三斜面到第三远端阻挡面的轴向距离变大而变小;第二接触面包括由远端到近端依次设置的第四远端阻挡面、第四斜面和第四近端阻挡面,基座边缘到第四斜面的最大垂直距离随第四斜面到第四近端阻挡面的轴向距离变大而变小;第三通槽设置在第四斜面上,并与过渡面对应设置;当连接轴与基座耦合时,第三通槽和过渡面共同形成闭合的预设通道,连接轴与基座拆卸后,第三通槽和过渡面相互分离,使预设通道为非闭合的。
在一些实施例中,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。
在一些实施例中,所述假体为二尖瓣夹子,或三尖瓣夹子。
在一些实施例中,第一活动件为第一夹合臂,第二活动件为第二夹合臂,第一夹合臂和第二夹合臂关于基座的轴线转动,且,所述第一段可移动地连接于第一夹合臂,第二段可移动地连接于第二夹合臂。
附图说明
图1为本申请一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为本申请一实施例提供的控制丝的结构示意图;
图4为图3中a部的局部放大图;
图5为本申请一实施例提供的控制丝、中心杆与预设通道配合的纵向剖视图;
图6为本申请一实施例提供的中心杆与预设通道配合的结构示意图;
图7为本申请另一实施例提供的控制丝、中心杆与预设通道配合的纵向剖视图;
图8为本申请一实施例提供的控制丝、中心杆与预设通道配合的横向剖视图;
图9为本申请另一实施例提供的控制丝、中心杆与预设通道配合的横向剖视图;
图10为本申请一实施例提供的连接轴与基座配合形成预设通道的纵向示意图;
图11为本申请另一实施例提供的连接轴与基座配合形成预设通道的纵向示意图;
图12为本申请另一实施例提供的连接轴与基座配合形成预设通道的纵向剖视图;
图13为本申请一实施例提供的二尖瓣夹子夹持二尖瓣瓣叶的简要示意图;
图14为本申请一实施例提供的夹合臂与控制丝配合时的结构示意图;
图15为本申请另一实施例提供的夹合臂与控制丝配合时的结构示意图;
图16为本申请另一实施例提供的夹合臂与控制丝配合时的结构示意图。
具体实施方式
本领域的普通技术人员可以理解,在本申请各实施方式中,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,基于以下各实施方式的种种变化和修改,也可以实现本申请所要求保护的技术方案。
在本申请各实施方式中,“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。在本申请各实施方式中,“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。
本申请实施方式提供一种假体系统,包括输送装置和假体;输送装置包括连接轴和控制丝;假体包括基座和第一活动件,其中,基座与连接轴可拆卸的耦合;预设通道,预设通道与连接轴轴线呈角度设置于连接轴和/或基座;控制丝具有依次相连的:第一段、第二段以及第三段,第一段和第三段中任一者至少与第二段连接的部分的尺寸大于第二段的尺寸,第一段用于独立地驱动第一活动件运动,第二段可容纳于预设通道;其中,预设通道具有第一状态和第二状态,当预设通道处于第一状态时,第一段与第三段使第二段约束于预设通道;当预设通道处于第二状态时,控制丝可与预设通道分离。
本申请实施方式提供的假体系统,在实施微创植入手术时,使得预设通道处于第一状态以通过控制丝的第一段与第三段使第二段限制在预设通道内部,继而在连接轴将假体经由人体自然腔道等手术路径输送至人体内的目标位置后,可通过控制丝的第一段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,以实现假体植入;当需要将输送装置与假体分离时,使得预设通道处于第二状态,在第二状态下控制丝可与预设通道分离,以便于控制丝与假体分离,进而从人体内抽出控制丝。此时,还可使得假体的基座与输送装置的连接轴拆卸,继而便于将连接轴从人体中撤回,以完成植入手术。如此,假体系统的输送装置能够安全可靠地调整假体中的活动件,实现假体状态的改变,使得假体系统更加安全,使得手术操作更加安全可靠。
同时,在预设通道处于第一状态时,第一段与第三段使第二段约束于预设通道,从而使得第二段一直处于预设通道内而无法相对于预设通道移动,继而可使得第一段以及第三段与第二段的相连处无法相对于预设通道移动,以避免第一段以及第三段会像在先技术中窜 出预设通道,继而避免出现在先技术中“控制丝易与输送装置的其他零部件或人体内的某些器官卡塞”的技术问题,从而降低手术风险。
为使本申请的目的、技术方案和优点更加清楚,下面将结合附图对本申请的实施方式进行详细的阐述。
参见图1至图16,本申请一些实施例提供的假体系统,包括:输送装置100和假体;输送装置100包括连接轴110和控制丝120;假体包括基座210和第一活动件,其中,基座210与连接轴110可拆卸的耦合;预设通道300,预设通道300与连接轴110的轴线呈角度设置于连接轴110和/或基座210;控制丝120具有依次相连的:第一段121、第二段122以及第三段123,第一段121和第三段123中任一者至少与第二段122连接的部分的尺寸大于第二段122的尺寸,第一段121用于独立地驱动第一活动件运动,第二段122容纳于预设通道300;其中,预设通道300具有第一状态和第二状态,当预设通道300处于第一状态时,第一段121与第三段123使第二段122被约束在预设通道300内;当预设通道300处于第二状态时,控制丝120可与预设通道300分离。
这里,预设通道300与连接轴110的轴线呈角度设置于连接轴110和/或基座210是指,预设通道300的延伸方向(即预设通道300的轴线)与连接轴110轴线之间具有大于0°且小于180°的夹角,且预设通道300设置于连接轴110和/或基座210。在一些实施例中,预设通道300的延伸方向与连接轴110轴线相互垂直。由于基座210与连接轴110耦合时,连接轴110的轴线与基座210的轴线共线。当预设通道300设置于基座210或者基座210与连接轴110之间时,预设通道300与连接轴110的轴线呈角度设置即为预设通道300与基座210的轴线呈角度设置。
第一段121和第三段123中任一者至少与第二段122连接的部分的尺寸大于第二段122的尺寸是指,第一段121与第二段122相连的部分的尺寸大于第二段122的尺寸,且第三段123与第二段122相连的部分的尺寸大于第二段122的尺寸。其中,这里的尺寸是指在其垂直延伸方向上的截面尺寸,如第二段122的尺寸为第二段122在垂直于第二段122延伸方向上的截面尺寸。控制丝120的横截面为圆形时,则控制丝120的尺寸为控制丝120的横截面的直径。在一实施例中,第二段122的尺寸为第二段122的直径。而当控制丝120的横截面为非圆形时,则控制丝120的尺寸为按照特定规则得出的尺寸,如:从横截面的几何中心到横截面边缘上某点的距离的两倍。在另一实施例中,第二段122的尺寸为第二段122的外接圆的直径。
如图8,在一些实施例中,为了便于制造控制丝120,第一段121各处的尺寸相同,第三段123各处的尺寸相同。即第一段121其他部分的尺寸等于第一段121与第二段122相连的部分的尺寸,第三段123其他部分的尺寸等于第三段123与第二段122相连的部分的尺寸。进一步,第二段122各处的尺寸也可相同。
如图9,在又一些实施例中,第一段121与第二段122相连的部分的尺寸大于第二段122的尺寸,而第一段121其他部分的尺寸小于第一段121与第二段122相连的部分的尺寸。 在另外一些实施例中,第三段123与第二段122相连的部分的尺寸大于第二段122的尺寸,而第三段123其他部分的尺寸小于第三段123与第二段122相连的部分的尺寸。
在一些实施例中,第一活动件活动设置在基座210上。其中,第一活动件活动设置在基座210上是指,第一活动件直接与基座210活动连接,或者,第一活动件通过其他零部件与基座210活动连接。本申请对此不做限定。
在一些实施例中,由于第一段121需控制第一活动件运动,故控制丝120由刚性、且弹性模量较大的材料制备而成,例如医用不锈钢,钛合金等。
进一步,预设通道300和控制丝120之间通过相互的尺寸配置,来实现当预设通道300处于第一状态时,第一段121和第三段123无法穿过预设通道300,只能邻接于预设通道300,而第二段122被限制在预设通道300内;当预设通道300处于第二状态时,控制丝120可与预设通道300分离。
在一些实施例中,预设通道300在第一状态时的尺寸和预设通道300在第二状态时的尺寸是不同的。具体而言,当预设通道300处于第一状态时,预设通道300用于容纳第二段122的部分具有第一尺寸;第一尺寸小于第一段121和第三段123中任一者与第二段122相连的部分的尺寸,且大于或等于第二段122的尺寸;当预设通道300处于第二状态时,预设通道300用于容纳第二段122的部分具有第二尺寸;第二尺寸大于第一段121和/或第三段123的尺寸。
在一些实施例中,“预设通道300处于第一状态时,预设通道300中用于容纳第二段122的部分具有的第一尺寸”是指,预设通道300处于第一状态时,预设通道300中用于收容控制丝120的第二段122的部分在垂直于预设通道300的延伸方向上的截面尺寸。在另外一些实施例中,“预设通道300处于第二状态时,预设通道300中用于容纳第二段122的部分具有的第二尺寸”是指,预设通道300处于第二状态时,预设通道300中用于收容控制丝120的第二段122的部分在垂直于预设通道300的延伸方向上的截面尺寸。
由于预设通道300的第一尺寸和控制丝120的尺寸被配置为第一尺寸小于第一段121和第三段123中任一者与第二段122相连的部分的尺寸,且大于或等于第二段122的尺寸。因此,可利用第二段122的尺寸小于或等于第一尺寸而使得第二段122可收纳于第一状态的预设通道300内;第一段121与第二段122相连的部分的尺寸大于第一尺寸而使得第一段121无法穿过第一状态的预设通道300;第三段123与第二段122相连的部分的尺寸大于第一尺寸而使得第三段123无法穿过第一状态的预设通道300,进而使得容纳于预设通道300的第二段122约束于预设通道内。
预设通道300的第二尺寸和控制丝120的尺寸被配置为第二尺寸大于或等于第一段121和/或第三段123的尺寸。因此,第一段121在其延伸方向上各处的尺寸均小于第二尺寸,和/或第三段123在其延伸方向上各处的尺寸均小于第二尺寸,使得控制丝120可以在第二状态下的预设通道300中移动,进而可以从预设通道300中分离。
如此,即可实现当预设通道300处于第一状态时,第一段121、第三段123无法穿过 预设通道300,而使得第二段122被约束在预设通道300内;且当预设通道300处于第二状态时,预设通道300允许控制丝120从预设通道300中脱离。
在一些实施例中,第二段122的长度与预设通道300的长度相同。如此,可使得第一段121以及第三段123中任一者与第二段122相连的一端邻近预设通道的一端口设置,使得第一段121和第三段123分别被卡在预设通道300的两端外,便于控制丝120对假体的活动件精确控制。此时,预设通道300仅用于容纳第二段122。
替代性的,第二段122的长度也可小于预设通道300的长度。此时,第一段121和第三段123中至少一者与第二段122的相连处可处于预设通道300内。即预设通道300既容纳第二段122,又容纳部分第一段121和/或第三段123。
在一些实施例中,输送装置100还包括中心杆130,通过控制中心杆130与预设通道300是否重合,以调整预设通道300的尺寸。具体而言,连接轴110和/或基座210设有沿连接轴110轴向布置的容纳道,其中,容纳道与预设通道300相交,容纳道与预设通道300重合的区域为重合区域;当中心杆130置入容纳道并占据至少部分重合区域时,预设通道300处于第一状态,预设通道300剩余部分区域中用于容纳第二段122的部分的尺寸为第一尺寸;当中心杆130位于重合区域外部时,预设通道300处于第二状态,预设通道300中用于容纳第二段122的部分的尺寸为第二尺寸。在一些实施例中,当中心杆130位于连接轴110与基座210的耦合处时,连接轴110与基座210至少保持径向相对静止。
如此,即可使得第二尺寸大于第一尺寸,从而便于满足第一尺寸小于第一段121和第三段123中任一者与第二段122相连的部分的尺寸、且大于或等于第二段122的尺寸,以及第二尺寸大于第一段121和/或第三段123的尺寸。
在一些实施例中,预设通道300可从第一状态切换为第二状态。进一步,当需使得预设通道300从第一状态切换为第二状态时,仅需使中心杆130位于重合区域外部即可实现。
在一些实施例中,中心杆130占据重合区域的尺寸为第三尺寸,第二尺寸大于或等于第三尺寸与第二段122的尺寸之和,且第二尺寸小于第三尺寸与第一段121和第三段123中任一者与第二段122相连的部分的尺寸之和。
在一些实施例中,预设通道300设置在连接轴110上,容纳道包括设置在连接轴110上的第一容纳段410,第一容纳段410与预设通道300重合的区域为重合区域;中心杆130置入第一容纳段410并占据至少部分重合区域,而使预设通道300处于第一状态。
在一些实施例中,重合区域的尺寸小于第二尺寸。
参见图5与图6,在一个例子中,容纳道包括设置在连接轴110上的第一容纳段410,以容纳中心杆130;预设通道300设置在连接轴110上,且预设通道300在连接轴110的内壁上形成直通槽301,还在连接轴110上形成了与直通槽301相对的第一壁孔302。第一容纳段410与预设通道300部分重合,第一壁孔302对应的区域为重合区域。当中心杆130置入第一容纳段410并占据至少部分重合区域,使预设通道300处于第一状态,预设通道300的空间至少包括由直通槽301和中心杆130的外表面中与直通槽301对应的部分所限定的空 间。当中心杆130没有占据重合区域时,预设通道300处于第二状态,此时预设通道300的空间由直通槽301和第一壁孔302所限定,直通槽301和第一壁孔302所限定的空间都用于容纳控制丝120。
在又一实施例中,重合区域的尺寸等于第二尺寸。
参见图7,在一个例子中,也与上述实施例类似,容纳道包括设置在连接轴110上的第一容纳段410,以容纳中心杆130;预设通道300设置在连接轴110上。区别在于,预设通道300在连接轴110上形成贯穿连接轴110的第二壁孔303。第一容纳段410与预设通道300重合,第二壁孔303区域为重合区域。中心杆130的尺寸小于第一容纳段410的尺寸,所以中心杆130只能占据部分重合区域,由此,第二壁孔303分为可由中心杆130占据空间对应的第一孔壁部分3032和不能被中心杆130占据的空间所对应的第二孔壁部分3031。当中心杆130置入第一容纳段410并占据部分重合区域,使预设通道300处于第一状态,预设通道300的空间由第二孔壁部分3031和中心杆130外表面对应部分所限定。当中心杆130没有占据重合区域时,预设通道300处于第二状态,此时第一孔壁部分3032和第二孔壁部分3031都可以容纳控制丝120,预设通道300的空间由第一孔壁部分3032和第二孔壁部分3031限定,即第二壁孔303所限定。
替代性地,预设通道300也可以设置在基座210上。容纳道包括设置在连接轴110上的第一容纳段410,以及设置在基座210上的第二容纳段,其中,第一容纳段410与第二容纳段在基座210与连接轴110可拆卸的耦合时相互连通,第二容纳段与预设通道300重合的区域为重合区域。当中心杆130置入第一容纳段410以及第二容纳段内并占据至少部分重合区域时,预设通道300处于第一状态。需要说明的是,预设通道300设置在基座210上的具体实施方式与上述实施例中预设通道300设置在连接轴110上的具体实施方式可相同,在此不再赘述。
替代性地,预设通道300还可以设置在连接轴110与基座210的耦合处。在一些实施例中,容纳道与预设通道300在连接轴110与基座210的耦合处重合,并在重合处形成重合区域。中心杆130置入容纳道内且伸至连接轴110与基座210的耦合处并占据至少部分重合区域,使预设通道300处于第一状态。
在一些实施例中,预设通道300在第一状态时的截面形状和预设通道300在第二状态时的截面形状不同。进一步,预设通道300设置于连接轴110和基座210的耦合处;当连接轴110和基座210耦合时,预设通道300处于第一状态,预设通道300为闭合的,闭合的预设通道300的尺寸与第二段122相匹配,以约束控制丝120;当连接轴110和基座210拆卸后,预设通道300处于第二状态,预设通道300为非闭合的,即预设通道300具有可以使第二段122脱离的缺口。
如此,当预设通道300处于第一状态时,可使得第一段121、第三段123无法穿过预设通道300,而使得第二段122被限制在预设通道300内;而当预设通道300处于第二状态时,第二段122能从预设通道300的缺口处与预设通道300分离,而使得控制丝120脱离预 设通道300的限制。
需要说明的是,预设通道300为闭合的是指,预设通道300在其横截面上的形状是闭合的;预设通道300为非闭合的是指,预设通道300在其横截面上的形状分成了非闭合的多个部分。
在一些实施例中,连接轴110具有第一接触面111;基座210具有与第一接触面111相匹配的第二接触面211;第一接触面111设有第一通槽112,第二接触面211设有第二通槽212;连接轴110与基座210耦合时,第一接触面111与第二接触面211相配合,第一通槽112与第二通槽212共同形成闭合的预设通道300;连接轴110与基座210拆卸后,第一接触面111与第二接触面211相互分离,使预设通道300为非闭合的。
参见图10,在一个例子中,第一接触面111包括由远端到近端依次设置的第一远端阻挡面1111,第一斜面1112和第一近端阻挡面1113;第二接触面211包括由远端到近端依次设置的第二远端阻挡面2111,第二斜面2112和第二近端阻挡面2113。第一远端阻挡面1111可以与第二远端阻挡面2111贴合。第一近端阻挡面1113可以与第二近端阻挡面2113贴合。第一斜面1112可以至少部分与第二斜面2112贴合。连接轴110的边缘到第一斜面1112的最大垂直距离h1随第一斜面1112到第一远端阻挡面1111的轴向距离变大而变小(即第一斜面1112被配置成自第一斜面1112的远端到第一斜面1112的近端,连接轴110的边缘到第一斜面1112的最大垂直距离h1逐渐减小);基座210的边缘到第二斜面2112的最大垂直距离h2随第二斜面2112到第二近端阻挡面2113的轴向距离变大而变小(即第二斜面2112被配置成自第二斜面2112的近端到第二斜面2112的远端,基座210的边缘到第二斜面2112的最大垂直距离h2逐渐减小)。这里,连接轴110边缘到第一斜面1112的最大垂直距离是指在同一横截面上,连接轴110边缘上各个点到第一斜面1112与横截面相交形成的交线之间所有垂直距离中最大的垂直距离。基座210的边缘到第二斜面2112的最大垂直距离是指在同一横截面上,基座210边缘上各个点到第二斜面2112与横截面相交形成的交线之间所有垂直距离中最大的垂直距离。如此,第二接触面211与第一接触面111的接触部分使得当连接轴110沿连接轴110轴向远离基座210移动时,连接轴110被约束相对于基座210在连接轴110径向上移动。因此,可以将约束连接轴110沿其轴向相对于基座210移动,转化为仅需约束连接轴110沿其径向相对于基座210移动即可,便于实现连接轴110与基座210之间的耦合。结合上述实施例,通过利用中心杆130使得连接轴110与基座210至少保持径向相对静止,即可实现连接轴110与基座210之间的耦合。进一步,第一通槽112设置在靠近第一近端阻挡面1113的第一斜面1112上。第二通槽212设置在靠近第二近端阻挡面2113的第二斜面2112上。第一通槽112包括第一槽壁和第一槽口。第二通槽212包括第二槽壁和第二槽口。第二段122可以从第一槽口脱离第一通槽112和/或可以从第二槽口脱离第二通槽212。第一槽壁和第二槽壁的横截面均为弧形。进一步地,第一槽壁和第二槽壁的横截面为圆弧形。当连接轴110与基座210耦合时,第一远端阻挡面1111和第二远端阻挡面2111贴合,第一斜面1112和第二斜面2112贴合,第一近端阻挡面1113和第二近端阻挡面2113 贴合。第一通槽112与第二通槽212形成了闭合状态的预设通道300。
这样一来,当第一通槽112的第一槽口与第二通槽212的第二槽口贴合时,第一通槽112的第一槽壁和第二通槽212的第二槽壁构成了闭合状态的预设通道300的侧壁。当连接轴110与基座210拆卸后,第一通槽112与第二通槽212分离,而使得第一通槽112的第一槽口与第二通槽212的第二槽口不再贴合,构成预设通道300的侧壁的第一通槽112的第一槽壁与第二通槽212的第二槽壁相分离,由此,预设通道300处于非闭合的状态。第二段122可以与预设通道300分离。
在又一些实施例中,连接轴110具有第一接触面111;基座210具有与第一接触面111相匹配的第二接触面211;第一接触面111或第二接触面211设有第三通槽113;连接轴110与基座210耦合时,第一接触面111与第二接触面211的部分相贴合,第三通槽113的槽壁与另一接触面相对的部分共同围成闭合的预设通道300;连接轴110与基座210拆卸后,第一接触面111与第二接触面211相互分离,使预设通道300为非闭合的。与上述实施例的区别在于,第一接触面111或第二接触面211上设有通槽。
参见图11,在一个例子中,第一接触面111包括由远端到近端依次设置的第三远端阻挡面1114,第三斜面1115和第三近端阻挡面1116;第二接触面211包括由远端到近端依次设置的第四远端阻挡面2114,第四斜面2115,过渡面2117和第四近端阻挡面2116。即过渡面2117设置在第四斜面2115和第四近端阻挡面2116之间。第三远端阻挡面1114可以与第四远端阻挡面2114贴合。第三近端阻挡面1116可以与第四近端阻挡面2116贴合。第三斜面1115可以至少部分与第四斜面2115贴合。连接轴110的边缘到第三斜面1115的最大垂直距离h3随第三斜面1115到第三远端阻挡面1114的轴向距离变大而变小(即第三斜面1115被配置成自第三斜面1115的远端到第三斜面1115的近端,连接轴110的边缘到第三斜面1115的最大垂直距离h3逐渐减小)。基座210的边缘到第四斜面2115的最大垂直距离h4随第四斜面2115到第四近端阻挡面2116的轴向距离变大而变小(即第四斜面2115被配置为自第四斜面2115的近端到第四斜面2115的远端,基座210的边缘到第四斜面2115的最大垂直距离h4逐渐减小)。第三通槽113设置在靠近第三近端阻挡面1114的第三斜面1115上,与过渡面2117对应。第三通槽113包括第三槽壁和第三槽口。第二段122可以从第三槽口脱离第三通槽113。第三槽壁的横截面为弧形。进一步地,第三槽壁的横截面为圆弧形。当连接轴110与基座210耦合时,第三远端阻挡面1114和第四远端阻挡面2114贴合,第三斜面1115和第四斜面2115贴合,第三近端阻挡面1116和第四近端阻挡面2116贴合。第三通槽113与过渡面2117形成了闭合状态的预设通道300。
这样一来,当第三通槽113的第三槽口贴合于过渡面2117时,第三通槽113的第三槽壁和过渡面2117构成了闭合状态的预设通道300的侧壁。当连接轴110与基座210拆卸后,第三通槽113与过渡面2117分离,而使得第三通槽113的第三槽口不再贴合于过渡面2117,构成预设通道300的侧壁的第三通槽113的第三槽壁与过渡面2117相分离,由此,预设通道300为非闭合的。第二段122可以与预设通道300分离。
替代地,在又一个例子中,图11中的过渡面2117也可设置在第一接触面111上,如位于第三斜面1115和第三近端阻挡面1116之间。此时,第三通槽113也可以设置在第二接触面211上,如位于第四斜面2115和第四近端阻挡面2116之间。即可将图11中的过渡面2117与第三通槽113的位置进行调换,且调换后的过渡面与第三通槽对应设置。当连接轴110与基座210耦合时,第四通槽与过渡面形成了闭合状态的预设通道300,当连接轴110与基座210拆卸后,第四通槽与过渡面分离,预设通道300为非闭合的。
在又一替代性实施例中,连接轴110包括第一耦合部114,基座210包括第二耦合部213,第一耦合部114或第二耦合部213轴向偏置布置,当第一耦合部114或第二耦合部213被驱使沿轴向设置时,第一耦合部114和第二耦合部213耦合,第一接触面115位于第一耦合部114面向第二耦合部213的一侧,第二接触面214位于第二耦合部213面向第一耦合部114的一侧。在此实施例中,如上述实施例所示,构成预设通道300的通槽可以为两个,分别设置在第一接触面115和第二接触面214;构成预设通道300的通槽也可以为一个,设置在第一接触面115或第二接触面214上。
进一步,第一耦合部114、第二耦合部214中的一者包括凸起116、另一者包括凹槽215;其中,第一耦合部114或第二耦合部213轴向偏置布置,以使凸起116与凹槽215分离;当第一耦合部114或第二耦合部213被驱使沿轴向设置时,凸起116容纳于凹槽215中。
以构成预设通道300的通槽为一个,且设置在第一接触面115上为例进行说明。如图12所示,在一个例子中,第一耦合部114还包括向内偏置的支撑件117和第五通槽118,凸起116位于支撑件117的远端,且垂直于支撑件117的轴线方向延伸,第五通槽118设置于支撑件117上,且第五通槽118包括第五槽口和第五槽壁;凹槽215设置于基座210的内壁;输送装置100还包括中心杆130,中心杆130可移动的设置于连接轴110内,当第一耦合部114需和第二耦合部213耦合时,中心杆130向远端移动并穿过第一耦合部114和第二耦合部213,以使支撑件114被驱使偏转直至支撑件114的轴线与连接轴110的轴线平行时,凸起116容纳于凹槽215中。此时,第五通槽118与第二耦合部213的内壁形成闭合的预设通道300,即第五槽口118贴合于第二耦合部213的内壁,第五槽壁118和第二耦合部213的内壁形成预设通道300的侧壁。当连接轴110与基座210拆卸后,第五通槽118与第二耦合部213的内壁分离,预设通道300为非闭合的。
在一些实施例中,假体包括一个活动件,即第一活动件。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。这里的“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,如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)束缚处于压缩态的覆膜支架,当覆膜支架定位到目标位置后,通过控制丝从覆膜支架上抽离束缚丝,以使得覆膜支架从压缩态转变为展开态。这里的“状态的变化”还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。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。“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。例如,用于治疗二尖瓣返流的二尖瓣夹子,通过控制丝控制二尖瓣夹子中的夹合臂(即第一活动件)相对转动来实现对二尖瓣瓣叶的夹持。
在另外一些实施例中,假体包括两个活动件,即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123控制第二活动件运动,来实现假体状态的变化。当需要将输送装置100与假体分离时,可使得预设通道300处于第二状态,从而使得控制丝120能够从预设通道300中脱离,以便于从人体内抽出控制丝120且使控制丝120与假体分离。这样一来,即可实现利用一根控制丝120控制假体的两个活动件(即第一活动件和第二活动件)运动。
在一些实施例中,假体为用于治疗二尖瓣返流的二尖瓣夹子200。需要强调的是,这里的假体为二尖瓣夹子200仅是举例说明,在其他的实施例中,假体也可不为二尖瓣夹子200,本申请对假体的具体类型不做限定。
如图13所示,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。在本实施例中,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。
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。
类似地,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400前后瓣叶的边缘。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输送到二尖瓣目标位置后,通过驱动夹合臂和夹合座的转动,以将二尖瓣400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。这里,二尖瓣夹子替代为三尖瓣夹子以治疗三尖瓣返流同样适用。
参见图1、图2和图15,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与第二夹合臂230通过过渡部102弹性连接。进一步,过渡部102设置在基座210的远端。更进一步,第一夹合臂220、过渡部102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。如图2所示,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。不再提拉第一段121时,第一夹合臂220转动以远离基座210,恢复原状。相应地,在提拉第三段123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。不再提拉第三段123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和图2,第一夹合座240和第二夹合座250均与基座210可转动连接。进一步,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,以更好地和第一夹合臂220包裹二尖瓣第一瓣叶边缘401。同样,第二夹合座250垂直于轴线方向的横截面形状为U形,以更好地和第二夹合臂230包裹二尖瓣第二瓣叶边缘402。当二尖瓣夹子200夹持二尖瓣瓣叶时,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挤压二尖瓣瓣叶边缘,实现二尖瓣夹子200对二尖瓣瓣叶的夹持。
本实施例对第一段121控制第一活动件运动,第三段123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,控制丝120可以与第一夹合臂220的分离。第三段123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,如图2、3所示,第一段121从预设通道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,以便于控制控制第一夹合臂220的转动。
在此实施例中,第二段122和第三段123均被配置为可脱离第一夹合臂220。如此,当需将控制丝120从第一夹合臂220上抽离时,可确保第三段123以及第二段122可从第一夹合臂220上抽离。
在一些实施例中,第三段123与第二段122的相连处为第一过渡部124,第一过渡部124在第二段122指向第三段123的方向上的横截面的面积逐渐增大。如此,在使得第二段122的尺寸小于或等于第一尺寸而使得第二段122可置于第一状态的预设通道300内时,还可使得第三段123至少与第二段122相连处的尺寸大于第一尺寸,而使第三段123无法穿过第一状态的预设通道300,并使得第二段122与第三段123的相连处为呈平滑过渡的第一过渡部124,以使第二段122与第三段123的相连处不存在明显凸起。
这样一来,在回撤控制丝120,而使得整个控制丝120从第一夹合臂220上抽离的过程中,可使得第二段122与第三段123能够较为顺畅依次从第一夹合臂220上抽离,而避免对第一夹合臂220的姿态和/或位置造成影响。而且,通过设置呈平滑过渡的第一过渡部124,在回撤控制丝120时,可避免控制丝120卡塞在假体系统的其他零部件上,同时还可避免控制丝120被磨损,继而减小控制丝120产生断裂的可能性。
参见图14,在一些实施例中,上述的附件为固定线223,固定线223通过捆扎、打 结等方式设置于第一夹合臂220,并且固定线223形成了用于与第一段121的弯曲部分互穿的本体226。
本体226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223还具有与本体226连接的固定结225,固定结225设置在第一夹合臂220上。即固定线223形成类似绳结的结构。其中,第一段121的弯曲部分穿过第一通孔以与本体226互穿。
进一步,第一夹合臂220在其表面设有第二通孔224,本体226从第一夹合臂220远离基座210的一侧穿过第二通孔224,固定结225设置于第一夹合臂220远离基座210的一侧,且固定结225被配置为无法穿过第二通孔224。
替代性地,固定线223的固定结225缠绕在第二通孔224周围,以与第一夹合臂220固定连接。
参见图15,在又一些实施例中,第一夹合臂220上设有两个第三通孔221,第一段121远离第二段122的一端(即弯曲部分的一端)从第一夹合臂220远离第一夹合座240的一侧穿过一第三通孔221,然后从第一夹合臂220的靠近第一夹合座240的一侧穿过另一第三通孔221。如此,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221,第一段121远离第二段122的一端(即弯曲部分的一端)交替穿过这些第三通孔221。如此,亦可使得第一段121的弯曲部分与第一夹合臂220互穿。
参见图16,在再一些实施例中,第一夹合臂220上设有凸起101,第一夹合臂220上的凸起101上设有第四通孔227,第一段121远离第二段122的一端(即弯曲部分的一端)穿过第四通孔227。如此,亦可使得第一段121的弯曲部分与第一夹合臂220互穿。进一步地,第四通孔227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123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。在一些实施例中,第一段121与第二段122的相连处可为与第一过渡部124具有相同作用的第二过渡部125,在此也不再赘述。
在另外一个例子中,第一段121和第二段122也可均被配置为可脱离第二夹合臂230。如此,当需将控制丝120从第二夹合臂230上抽离时,可确保第一段121以及第二段122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、图2,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。基座210为中空结构,滑块263的竖直部分可移动地容纳于基座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移动,以使第一夹合座240,第二夹合座250转动。更进一步地,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140,导管140设有沿导管140轴向延伸的两个第二通道;第一段121远离第二段122的一端自一个第二通道远端穿过第二通道并延伸至该第二通道近端,第三段123远离第二段122的一端自另一个第二通道远端穿过第二通道并延伸至该第二通道近端。如此,可便于操作者在导管140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140近端提拉第三段123远离第二段122的一端以调整第二夹合臂230的转动角度。当需要将控制丝120与二尖瓣夹子200分离时,将预设通道调整至第二状态,操作者在导管140近端抽拉第一段121远离第二段122的一端或者抽拉第三段123远离第二段122的一端,实现控制丝120与二尖瓣夹子200的分离。
需要说明的是,本申请对连接轴110和基座210可拆卸地耦合的具体实施方式不做限定。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,如美国专利文献US20210145574A1中说明书附图图5A、5B的方式,又如美国专利文献US20210145574A1中说明书附图图6A、6B的方式,亦如中国专利文献CN102395331B中说明书附图图82A、82B的方式,还可如中国专利文献CN102395331B中说明书附图图84的方式等。
继续参见图1至图16,本申请的另外一些实施例还提供一种输送装置100,用于输送假体,假体包括基座210和第一活动件,输送装置100包括连接轴110和控制丝120;连接轴110与基座210可拆卸的耦合;预设通道300,预设通道300与连接轴110的轴线呈角度设置于连接轴110,或者预设通道300与连接轴110的轴线呈角度设置于连接轴110和基座210之间;控制丝120具有依次相连的:第一段121、第二段122以及第三段123,第一段121和第三段123中任一者至少与第二段122连接的部分的尺寸大于第二段122的尺寸,第一段121用于独立地驱动第一活动件运动,第二段122容纳于预设通道300;其中,预设通道300具有第一状态和第二状态,当预设通道300处于第一状态时,第一段121与第三段123使第二段122被约束在预设通道300内;当预设通道300处于第二状态时,控制丝120可与预设通道300分离。
事实上,此实施例提供的输送装置100与上述其他实施例提供的部分的输送装置100(这里的部分的输送装置100是指,包括设有预设通道的连接轴110的输送装置100,或包 含的连接轴110与基座210之间设置有预设通道的输送装置100)具有相同的结构和有益效果,在此不再赘述。
本领域的普通技术人员可以理解,上述各实施方式是实现本申请的具体实施例,而在实际应用中,可以在形式上和细节上对其作各种改变,而不偏离本申请的精神和范围。任何本领域技术人员,在不脱离本申请的精神和范围内,均可作各自更动与修改,因此本申请的保护范围应当以权利要求限定的范围为准。

Claims (18)

  1. 一种假体系统,其中,包括输送装置和假体;
    所述输送装置包括连接轴和控制丝;
    所述假体包括基座和第一活动件,其中,所述基座与所述连接轴可拆卸的耦合;
    预设通道,所述预设通道与所述连接轴轴线呈角度设置于所述连接轴和/或所述基座;
    所述控制丝具有依次相连的:第一段、第二段以及第三段,所述第一段和所述第三段中任一者至少与所述第二段连接的部分的尺寸大于所述第二段的尺寸,所述第一段用于独立地驱动所述第一活动件运动,所述第二段容纳于所述预设通道;
    其中,所述预设通道具有第一状态和第二状态,当所述预设通道处于所述第一状态时,所述第一段与所述第三段使所述第二段约束于所述预设通道;当所述预设通道处于所述第二状态时,所述控制丝可与所述预设通道分离。
  2. 根据权利要求1所述的假体系统,其中,
    当所述预设通道处于所述第一状态时,所述预设通道中用于容纳所述第二段的部分具有第一尺寸;所述第一尺寸小于所述第一段和所述第三段中任一者与所述第二段相连的部分的尺寸,且大于或等于所述第二段的尺寸;
    当所述预设通道处于所述第二状态时,所述预设通道中用于容纳所述第二段的部分具有第二尺寸;所述第二尺寸大于所述第一段和/或所述第三段的尺寸。
  3. 根据权利要求2所述的假体系统,其中,
    所述输送装置还包括中心杆;
    所述连接轴和/或所述基座设有沿所述连接轴轴向布置的容纳道,其中,所述容纳道与所述预设通道相交,所述容纳道与所述预设通道重合的区域为重合区域;
    当所述中心杆置入所述容纳道并占据至少部分所述重合区域时,所述预设通道处于所述第一状态,所述预设通道剩余部分区域中用于容纳所述第二段的部分的尺寸为所述第一尺寸;
    当所述中心杆在所述重合区域外部时,所述预设通道处于所述第二状态,所述预设通道中用于容纳所述第二段的部分的尺寸为所述第二尺寸。
  4. 根据权利要求3所述的假体系统,其中,
    所述中心杆占据所述重合区域的尺寸为第三尺寸,所述第二尺寸大于或等于所述第三尺寸与所述第二段的尺寸之和,且所述第二尺寸小于所述第三尺寸与所述第一段和所述第三段中任一者与所述第二段相连的部分的尺寸之和。
  5. 根据权利要求3所述的假体系统,其中,
    所述预设通道设置于所述连接轴;
    所述容纳道包括设置在所述连接轴上的第一容纳段,所述第一容纳段与所述预设通道重合的区域为所述重合区域;
    所述中心杆置入所述第一容纳段并占据至少部分所述重合区域,而使所述预设通道处于所述第一状态。
  6. 根据权利要求3所述的假体系统,其中,
    所述预设通道设置于所述基座;
    所述容纳道包括设置在所述连接轴上的第一容纳段,以及设置在所述基座上的第二容纳段,其中,所述第一容纳段与所述第二容纳段在所述基座与所述连接轴可拆卸的耦合时相互连通,所述第二容纳段与所述预设通道重合的区域为所述重合区域;
    所述中心杆置入所述第一容纳段以及所述第二容纳段内并占据至少部分所述重合区域,而使所述预设通道处于所述第一状态。
  7. 根据权利要求3所述的假体系统,其中,
    所述预设通道设置于所述连接轴与所述基座的耦合处;
    所述容纳道与所述预设通道在所述耦合处重合,并在重合处形成所述重合区域。
  8. 根据权利要求3-7任一项所述的假体系统,其中,
    当所述重合区域的尺寸等于所述第二尺寸时,所述中心杆占据部分所述重合区域;
    当所述重合区域的尺寸小于所述第二尺寸时,所述中心杆占据至少部分所述重合区域。
  9. 根据权利要求1所述的假体系统,其中,
    所述预设通道设置于所述连接轴和所述基座的耦合处;
    当所述连接轴和所述基座耦合时,所述预设通道处于所述第一状态,所述预设通道为闭合的;
    当所述连接轴和所述基座拆卸后,所述预设通道处于所述第二状态,所述预设通道为非闭合的。
  10. 根据权利要求9所述的假体系统,其中,
    所述连接轴具有第一接触面;
    所述基座具有与所述第一接触面相匹配的第二接触面;
    所述第一接触面设有第一通槽,所述第二接触面设有第二通槽;
    所述连接轴与所述基座耦合时,所述第一接触面与所述第二接触面相配合,所述第一通槽与所述第二通槽共同形成闭合的所述预设通道;
    所述连接轴与所述基座拆卸后,所述第一接触面与所述第二接触面相互分离,使所述预设通道为非闭合的。
  11. 根据权利要求10所述的假体系统,其中,
    所述第一接触面包括由远端到近端依次设置的第一远端阻挡面,第一斜面和第一近端阻挡面,所述连接轴边缘到所述第一斜面的最大垂直距离随所述第一斜面到所述第一远端阻挡面的轴向距离变大而变小;
    所述第二接触面包括由远端到近端依次设置的第二远端阻挡面,第二斜面和第二近端阻挡面,所述基座边缘到所述第二斜面的最大垂直距离随所述第二斜面到所述第二近端阻挡面的轴向距离变大而变小;
    所述第一通槽设置在所述第一斜面上,所述第二通槽对应地设置在所述第二斜面上,当所述连接轴与所述基座耦合时,所述第一通槽和所述第二通槽共同形成闭合的所述预设通道,所述连接轴与所述基座拆卸后,所述第一通槽和所述第二通槽相互分离,使所述预设通道为非闭合的。
  12. 根据权利要求9所述的假体系统,其中,
    所述连接轴具有第一接触面;
    所述基座具有与所述第一接触面相匹配的第二接触面;
    所述第一接触面或所述第二接触面设有第三通槽;
    所述连接轴与所述基座耦合时,所述第一接触面与所述第二接触面相配合,所述第三通槽的槽壁与另一接触面相对的部分共同形成闭合的所述预设通道;
    所述连接轴与所述基座拆卸后,所述第一接触面与所述第二接触面相互分离,使所述预设通道为非闭合的。
  13. 根据权利要求12所述的假体系统,其中,
    所述第一接触面包括由远端到近端依次设置的第三远端阻挡面、第三斜面和第三近端阻挡面,所述连接轴边缘到所述第三斜面的最大垂直距离随所述第三斜面到所述第三远端阻挡面的轴向距离变大而变小;
    所述第二接触面包括由远端到近端依次设置的第四远端阻挡面、第四斜面、过渡面和第四近端阻挡面,所述基座边缘到所述第四斜面的最大垂直距离随所述第四斜面到所述第四近端阻挡面的轴向距离变大而变小;
    所述第三通槽设置在所述第三斜面上,并与所述过渡面对应设置;
    当所述连接轴与所述基座耦合时,所述第三通槽和所述过渡面共同形成闭合的所述预设通道,所述连接轴与所述基座拆卸后,所述第三通槽和所述过渡面相互分离,使所述预设通道为非闭合的。
  14. 根据权利要求12所述的假体系统,其中,
    所述第一接触面包括由远端到近端依次设置的第三远端阻挡面、第三斜面、过渡面和第三近端阻挡面,所述连接轴边缘到所述第三斜面的最大垂直距离随所述第三斜面到所述第三远端阻挡面的轴向距离变大而变小;
    所述第二接触面包括由远端到近端依次设置的第四远端阻挡面、第四斜面和第四近端阻挡面,所述基座边缘到所述第四斜面的最大垂直距离随所述第四斜面到所述第四近端阻挡面的轴向距离变大而变小;
    所述第三通槽设置在所述第四斜面上,并与所述过渡面对应设置;
    当所述连接轴与所述基座耦合时,所述第三通槽和所述过渡面共同形成闭合的所述预设通道,所述连接轴与所述基座拆卸后,所述第三通槽和所述过渡面相互分离,使所述预设通道为非闭合的。
  15. 根据权利要求1-14任一项所述的假体系统,其中,
    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。
  16. 根据权利要求15所述的假体系统,其中,
    所述假体为二尖瓣夹子,或三尖瓣夹子。
  17. 根据权利要求16所述的假体系统,其中,
    所述第一活动件为第一夹合臂,所述第二活动件为第二夹合臂,所述第一夹合臂和所述第二夹合臂关于所述基座的轴线转动,且,
    所述第一段可移动地连接于所述第一夹合臂,所述第二段可移动地连接于所述第二夹合臂。
  18. 一种输送装置,用于输送假体,所述假体包括基座和第一活动件,其中,
    所述输送装置包括连接轴和控制丝;
    所述连接轴与所述基座可拆卸的耦合;
    预设通道,所述预设通道与所述连接轴轴线呈角度设置于所述连接轴,或者所述预设通道与所述连接轴轴线呈角度设置于所述连接轴和所述基座之间;
    所述控制丝具有依次相连的:第一段、第二段以及第三段,所述第一段和所述第三段中任一者至少与所述第二段连接的部分的尺寸大于所述第二段的尺寸,所述第一段用于独立地驱动所述第一活动件运动,所述第二段容纳于所述预设通道;
    其中,所述预设通道具有第一状态和第二状态,当所述预设通道处于所述第一状态时,所述第一段与所述第三段使所述第二段约束于所述预设通道;当所述预设通道处于所述第二状态时,所述控制丝可与所述预设通道分离。
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