WO2023208002A1 - 输送装置及医疗器械系统 - Google Patents

输送装置及医疗器械系统 Download PDF

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Publication number
WO2023208002A1
WO2023208002A1 PCT/CN2023/090694 CN2023090694W WO2023208002A1 WO 2023208002 A1 WO2023208002 A1 WO 2023208002A1 CN 2023090694 W CN2023090694 W CN 2023090694W WO 2023208002 A1 WO2023208002 A1 WO 2023208002A1
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WO
WIPO (PCT)
Prior art keywords
outer sheath
handle
sheath
tube
inner sheath
Prior art date
Application number
PCT/CN2023/090694
Other languages
English (en)
French (fr)
Inventor
吴能标
李建民
Original Assignee
杭州德诺电生理医疗科技有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from CN202210462159.XA external-priority patent/CN116999111A/zh
Priority claimed from CN202221018369.1U external-priority patent/CN217338694U/zh
Application filed by 杭州德诺电生理医疗科技有限公司 filed Critical 杭州德诺电生理医疗科技有限公司
Publication of WO2023208002A1 publication Critical patent/WO2023208002A1/zh

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord

Definitions

  • This application relates to the technical field of medical devices, specifically, to a delivery device and a medical device system.
  • Percutaneous interventional therapy is a disease treatment method that has developed very rapidly in recent years, and its applicable fields are becoming more and more extensive. Among them, transcatheter interventional treatment method can place devices and/or drugs into the heart, arteries and veins, etc. of the human body.
  • Some implantable devices in the related art have two connectors spaced apart in the axial direction. After the implantable device is released in the patient's body, the sheath of the delivery device needs to be detached from the two connectors in sequence.
  • the embodiment of the present application provides a conveying device that can simplify the handle structure to solve problems existing in related technologies.
  • the present application provides a delivery device, including an outer sheath member and an inner sheath member.
  • the outer sheath member includes an outer sheath handle and an outer sheath tube at least partially disposed distal to the outer sheath handle. Assembly, the outer sheath handle and the outer sheath tube assembly both form a cavity between their respective proximal ends and distal ends, and the two cavities are connected; the outer sheath handle is used for operator operation, To drive the outer sheath assembly to move, the distal end of the outer sheath assembly is used to detachably connect with the implantable device; the inner sheath member includes an inner sheath handle and is at least partially disposed distal to the inner sheath handle.
  • the inner sheath assembly on the side is used to penetrate the two cavities, and the distal end of the inner sheath assembly is used to detachably connect with the implantable device, at least part of which The inner sheath handle is exposed from the outer sheath handle, and the inner sheath handle is used by an operator to drive the inner sheath assembly to move.
  • the present application provides a medical device system, including an implantable device and the above-mentioned delivery device.
  • the implantable device includes a first connecting piece and a second connecting piece that are spaced apart from each other; the outer sheath assembly has The distal end is used to detachably connect to the first connector, the distal end of the inner sheath assembly is used to detachably connect to the second connector; the delivery device is used to transfer the implantable device Delivered and released into the patient's body.
  • the delivery device includes an outer sheath member and an inner sheath member.
  • the outer sheath member includes an outer sheath handle and an outer sheath tube assembly connected to the outer sheath handle.
  • the inner sheath member includes The inner sheath handle and the inner sheath tube assembly connected with the inner sheath handle.
  • the outer sheath handle can be operated by the operator to drive the outer sheath assembly; at least Part of the inner sheath handle is exposed to the outer sheath handle.
  • the inner sheath handle can be operated by the operator to drive the movement of the inner sheath tube assembly.
  • the operator can then directly and independently operate either of the inner sheath handle and the outer sheath handle to drive the inner sheath tube assembly.
  • the sheath assembly and the outer sheath assembly realize relative movement, simplifying the internal driving structure of the delivery device and making it convenient for the operator to operate.
  • Figure 1 shows a schematic diagram of a medical device system according to an embodiment of the present application.
  • Figure 2 shows a schematic diagram of an implantable device according to an embodiment of the present application.
  • Figure 3 shows a schematic diagram of a conveying device according to an embodiment of the present application.
  • Figure 4 shows a schematic diagram of the outer sheath component of the embodiment of the present application.
  • Figure 5 shows a schematic diagram of the inner sheath component of the embodiment of the present application.
  • FIG. 6 shows a partial cross-sectional view of the conveying device shown in FIG. 3 along line I-I.
  • Figure 7 shows a schematic diagram of the locking member according to the embodiment of the present application.
  • Figure 8 shows a cross-sectional view of the locking member according to the embodiment of the present application.
  • Figure 9 shows a partial cross-sectional view of the outer sheath member shown in Figure 4 along line II-II.
  • Figure 10 shows a schematic diagram of the first liquid injection joint according to the embodiment of the present application.
  • Figure 11 shows an exploded schematic view of the first liquid injection joint according to the embodiment of the present application.
  • Figure 12 shows a cross-sectional view of the first liquid injection joint according to the embodiment of the present application.
  • Figure 13 shows a schematic diagram of the second base body according to the embodiment of the present application.
  • Figure 14 shows a schematic diagram of the two ends of the connecting tube connected to the outer sheath connector and the first liquid injection connector respectively according to the embodiment of the present application.
  • Figure 15 shows a partial cross-sectional view of the inner sheath component of the embodiment of the present application.
  • FIG. 16 shows a partial enlarged view of position A in FIG. 9 .
  • Outer sheath tube assembly 21. Outer sheath hose; 22. Outer conductive head; 4. Inner Sheath handle; 41, inner handle shell; 411, inner sheath interface; 412, second opening; 42, second liquid injection connector; 421, first channel; 422, second channel; 43, second conductive connector; 44. Three-way valve; 45. Guide wire port; 5. Inner sheath tube assembly; 51. Inner sheath hose; 52. Inner conductive head; 53. Guide sleeve; 54. Reinforcement tube; 6. Locking member; 61.
  • Figure 1 shows a schematic diagram of a medical device system according to an embodiment of the present application.
  • the medical device system in the embodiment of the present application includes a delivery device 10 , an implantable device 8 and a loader 7 .
  • the delivery device 10 is used to deliver and implant the implantable device 8 into the patient's body through interventional treatment.
  • the loader 7 is set on the periphery of the delivery device 10 and is used to load the implantable device 8 into the delivery device 10 .
  • the implantable device 8 may be a cardiac occluder, a blood vessel occluder, a blood vessel filter, or other types.
  • the implantable device 8 is a left atrial appendage occluder as an example. It can be understood that the implantable device 8 can also be other types of implantable devices.
  • FIG. 2 shows a schematic diagram of the implantable device 8 according to the embodiment of the present application.
  • the implantable device 8 is a left atrial appendage occluder, including an expandable body 88 and a first connecting member 83 and a second connecting member 84 provided on the expandable body 88 .
  • the first connecting piece 83 and the second connecting piece 84 are spaced apart in the axial direction of the implantable device 8 and are used to connect with the delivery device 10 .
  • first connector 83 is detachably connected to the distal end of the outer sheath assembly 2 of the delivery device 10
  • second connector 84 is detachably connected to the distal end of the inner sheath assembly 5 of the delivery device 10, which will be described in detail later. .
  • the expandable body 88 includes a sealing disk 81 and an anchoring disk 82 that are spaced apart in the axial direction of the implantable device 8 , and the sealing disk 81 is disposed at the proximal end of the anchoring disk 82 .
  • the first connecting member 83 is provided on the proximal side of the second connecting member 84 .
  • the first connecting member 83 is provided on the sealing disk 81
  • the second connecting member 84 is provided on the anchoring disk 82 .
  • distal end refers to the operation of the delivery device 10 along the delivery path during the operation. Defined by the distance of the person. Specifically, the end/side of a component that is close to the operator along the conveying path is called the "proximal end”/"near side", and the end/side that is far away from the operator along the conveying path is called the “distal end”/"far side” .
  • the implantable device 8 is released to the mouth of the left atrial appendage, and after the first connecting member 83 and the second connecting member 84 are respectively detached from the delivery device 10, the distal end of the delivery device 10 is withdrawn from the body.
  • both the first connecting piece 83 and the second connecting piece 84 can be connected to the conveying device 10 in a circumferential rotation-detachable connection relationship.
  • the first connecting piece 83 is threadedly connected to the conveying device 10
  • the second connecting piece 84 is connected to the conveying device 10 through a threaded connection.
  • the conveying device 10 is threaded.
  • first connecting member 83 and the second connecting member 84 may also have a pluggable and detachable connection relationship with the delivery device 10 .
  • first connector 83 is indirectly connected to the distal end of the outer sheath assembly 2
  • second connector 84 is indirectly connected to the distal end of the inner sheath assembly 5 .
  • the sealing disk 81 and the anchoring disk 82 can both be made of conductive materials.
  • the sealing disk 81 uses a skeleton to conduct electricity.
  • the first connector 83 is electrically connected to the skeleton of the sealing disk 81.
  • the anchoring disk 82 is provided with a conductive structure.
  • the second connector 84 is electrically connected to the electrode 821 of the anchoring plate 82 .
  • the first connecting member 83 and the second connecting member 84 are also used to transmit electrical energy.
  • a plurality of fixing parts are provided between the first connecting part 83 and the second connecting part 84 , namely the first fixing part 85 , the second fixing part 86 and the third fixing part 87 respectively.
  • These fasteners are used to connect the sealing disk 81 and the anchoring disk 82 and play an insulating role.
  • the sealing disk 81 is mesh-shaped and can be manufactured by a weaving or cutting process.
  • the first connector 83 is connected to the proximal end of the sealing disk 81 and is preferably also used to gather the proximal end of the braided wire in the sealing disk 81 .
  • the first fixing part 85 is arranged on the sealing plate The distal end of 81, preferably, the first fixing member 85 is also used to converge the distal end of the braided wire of the sealing disk 81.
  • the first fixing part 85 may be made of conductive material or insulating material.
  • a membrane is provided on the surface of the sealing disk 81 to achieve flow blocking and/or insulation functions.
  • the membrane body may be disposed on at least part of the outer surface of the sealing disk 81 , and/or disposed on at least part of the inner surface of the sealing disk 81 .
  • the anchoring plate 82 can be made by a weaving process or a cutting process. The ends of the anchoring disc 82 are bundled together and pressed between the second fixing part 86 and the third fixing part 87 . The second fixing part 86 and the third fixing part 87 are pressed together.
  • the third fixing members 87 may all be made of insulating material.
  • the second connecting member 84 is disposed at the distal end of the third fixing member 87 to ensure the insulation between the sealing disk 81 and the anchoring disk 82 and the insulation between the anchoring disk 82 and the second connecting member 84 .
  • a membrane is provided on the surface of the anchoring plate 82 to achieve flow blocking and/or insulation functions.
  • the membrane body may be disposed on at least part of the outer surface of the anchoring plate 82 , and/or disposed on at least part of the inner surface of the anchoring plate 82 .
  • the expandable body 88 includes a sealing disk 81 and an anchoring disk 82, which is a double disk structure.
  • the expandable body 88 has other structural forms, such as a single disk structure or a three-disc structure or more disk structures.
  • the expandable body 88 has a single disk structure and is plunger-shaped.
  • FIG. 2 only uses FIG. 2 as an example to illustrate how to achieve insulation between the sealing disk 81 and the anchoring disk 82 .
  • other methods are used to achieve insulation between the first connecting member 83 and the second connecting member 84 .
  • FIG. 3 shows a schematic diagram of the conveying device 10 according to the embodiment of the present application.
  • the delivery device 10 in the embodiment of the present application includes an outer sheath member 100 and an inner sheath member 200.
  • the inner sheath member 200 is movably inserted into the outer sheath member 100.
  • the distal end of the outer sheath member 100 is detachably connectable to the first connector 83 of the implantable device 8 .
  • the distal end of the inner sheath member 200 is detachably connectable to the second connector 84 of the implantable device 8 .
  • the distal end of the outer sheath member 100 and the first connector 83 may be connected by a plug-in or a circumferential rotation. When it is a circumferential rotation connection, it can be a threaded connection.
  • the distal end of the inner sheath member 200 and the second connector 84 may be connected by a plug-in or a circumferential rotation. When it is a circumferential rotation connection, it can be a threaded connection.
  • FIG. 4 shows a schematic diagram of the outer sheath member 100 according to the embodiment of the present application.
  • the outer sheath member 100 includes an outer sheath handle 1 and an outer sheath tube assembly 2 . At least part of the outer sheath tube assembly 2 is disposed distal to the outer sheath handle 1 . Both the outer sheath handle 1 and the outer sheath tube assembly 2 form a cavity between their respective proximal ends and distal ends, and the two cavities are connected.
  • the outer sheath tube assembly 2 includes an outer sheath hose 21 and an outer conductive head 22 .
  • the outer conductive head 22 is disposed at the distal end of the outer sheath hose 21 for connection with the first connector 83 .
  • the connection mode between the outer conductive head 22 and the first connecting member 83 can be a plug-in connection or a circumferential rotation connection.
  • the outer sheath tube assembly 2 can be driven to move synchronously.
  • the outer sheath handle 1 is used for the operator to operate to drive the outer sheath assembly 2 to move, for example, to drive the outer sheath assembly 2 to produce circumferential rotation and/or axial movement, so that the outer sheath member 100 is in contact with the implantable device.
  • the first connecting piece 83 of 8 realizes connection and detachment, and can be used to drive the first connecting piece 83 to move.
  • FIG. 5 shows a schematic diagram of the inner sheath component 200 according to the embodiment of the present application.
  • the inner sheath member 200 includes an inner sheath handle 4 and an inner sheath tube assembly 5 . At least part of the inner sheath assembly 5 is disposed on the distal side of the inner sheath handle 4 , and the inner sheath assembly 5 is used to pass through the two cavities of the outer sheath member 100 .
  • the inner sheath handle 4 is used for the operator to operate to drive the inner sheath assembly 5 to make synchronous movements, for example, to drive the inner sheath assembly 5 to produce circumferential rotation and/or axial movement.
  • the inner sheath tube assembly 5 includes an inner sheath hose 51 and an inner conductive head 52 .
  • the inner conductive head 52 is provided at the distal end of the inner sheath hose 51 for connection with the second connector 84 .
  • the connection method between the inner conductive head 52 and the second connecting member 84 may be a plug-in connection or a circumferential rotation connection.
  • At least part of the inner sheath handle 4 is exposed from the outer sheath handle 1.
  • the inner sheath member 200 can be moved in the circumferential direction and/or axial direction relative to the outer sheath member 100 , so that the inner sheath member 200 and the second connection member 84 of the implantable device 8 can be realized. connected, detached, and can be used to drive the second connecting member 84 to move.
  • the inner sheath handle 4 and the outer sheath handle 1 are spaced apart in the axial direction. In other words, the inner sheath handle 4 is completely exposed from the outer sheath handle 1 .
  • the inner sheath handle 4 and the outer sheath handle 1 are arranged at intervals in the axial direction, there is no overlapping structure in the radial direction between the inner sheath handle 4 and the outer sheath handle 1, thereby reducing the size of the outer sheath handle 1 in the radial direction.
  • the inner sheath handle 4 is completely exposed to the outer sheath handle 1, making it more convenient for the operator to operate the inner sheath handle 4, for example, operating the inner sheath handle 4 to achieve axial movement and/or circumferential rotation.
  • the outer sheath handle 1 and the inner sheath handle 4 are arranged sequentially along the axial direction and are used to accept the operator's control.
  • the operator can hold the outer sheath handle 1 with one hand and the inner sheath handle 4 with the other hand.
  • the operator can operate the inner sheath handle 4 to generate relative movement in the axial or circumferential direction relative to the outer sheath handle 1 to control
  • the inner sheath assembly 5 and the outer sheath assembly 2 produce corresponding relative movements.
  • the distal end of the inner sheath handle 4 may be hidden within the outer sheath handle 1 , while the proximal end of the inner sheath handle 4 is exposed from the outer sheath handle 1 .
  • the operator can operate the proximal end of the inner sheath handle 4 to drive the inner sheath member 200 to move axially and/or circumferentially.
  • the inner sheath handle 4 is provided at the proximal end of the delivery device 10 , and the inner sheath tube assembly 5 can be driven by the inner sheath handle 4 to move proximally from the cavity of the outer sheath member 100 until it is completely separated from the outer sheath member 100 .
  • the inner sheath member 200 can move axially to an unlimited length relative to the outer sheath member 100 , so that the inner sheath member 200 can be completely separated from the outer sheath member 100 .
  • the method that can be adopted is: after the inner conductive head 52 of the inner sheath member 200 is detached from the second connector 84, the inner sheath member 200 is detached from the implantable device 8 directly.
  • the member 200 is withdrawn from the patient's body, that is, the inner sheath member 200 is completely withdrawn from the outer sheath member 100 from the proximal side of the outer sheath member 100 and is completely separated from the outer sheath member 100 .
  • the outer conductive head 22 of the outer sheath member 100 is detached from the first connecting member 83 .
  • the inner sheath member 200 will not affect the outer sheath during the rotational detachment process of the outer sheath member 100 .
  • the rotational movement of the member 100 makes the rotation and release of the outer sheath member 100 more convenient.
  • the advantage that the inner sheath member 200 can be completely detached from the outer sheath member 100 also applies to the plug-and-play connection between the outer sheath member 100 and the first connector 83 .
  • the inner sheath member 200 and the outer sheath member 100 are detached from the implantable device 8 in the following detachment manner: the inner conductive head 52 of the inner sheath member 200 is first detached from the second connector 84, and then Then move the inner sheath member 200 proximally a certain distance to prevent the inner sheath handle 4 from being too close to the outer sheath handle 1, making it difficult for the operator to operate the outer sheath handle 1.
  • the inner sheath tube assembly 5 in the inner sheath member 200 Also located inside the outer sheath member 100 .
  • the outer conductive head 22 of the outer sheath member 100 is detached from the first connector 83, and finally the inner sheath member 200 and the outer sheath member 100 are withdrawn from the patient's body together.
  • the delivery device 10 in the embodiment of the present application includes an outer sheath member 100 and an inner sheath member 200.
  • the outer sheath member 100 includes an outer sheath handle 1 and an outer sheath tube assembly 2 connected to the outer sheath handle 1.
  • the inner sheath member 200 includes an inner sheath.
  • the outer sheath handle 1 can be operated by the operator to drive the outer sheath assembly 2 to move, and the inner sheath handle 4 can be operated by the operator to drive the inner sheath assembly 5 to move.
  • the operator can directly operate the inner sheath handle 4 to independently control the movement of the inner sheath tube assembly 5, thereby simplifying the handle structure and making it convenient for the operator to operate.
  • FIG. 6 shows a partial cross-sectional view of the conveying device 10 according to the embodiment of the present application.
  • Figure 7 shows a schematic diagram of the locking member 6 according to the embodiment of the present application.
  • Figure 8 shows a cross-sectional view of the locking member 6 according to the embodiment of the present application.
  • the delivery device 10 also includes a locking member 6, which is connected between the outer sheath handle 1 and the inner sheath tube assembly 5.
  • the tightening member 6 is mutually convertible between a locked state and an unlocked state. In the unlocked state, the outer sheath member 100 and the inner sheath member 200 can move relative to each other. In the locked state, the locking member 6 deforms and clamps the inner sheath assembly 5, thereby preventing the inner sheath member 200 from interacting with the outer sheath member. 100 produces relative motion.
  • the inner sheath member 200 and the outer sheath member 100 can be prevented from relative movement, and the operator can avoid misoperation of the inner sheath member 200 during the delivery and release of the implantable device 8 .
  • preventing the relative movement of the inner sheath member 200 and the outer sheath member 100 includes circumferential movement and axial movement.
  • part of the locking member 6 is disposed in the cavity of the outer sheath handle 1 , and the inner sheath tube assembly 5 passes through the locking member 6 .
  • the locking member 6 includes a first locking tube 61 , a second locking tube 62 , an extrusion part 63 and a clamping part 64 .
  • the first locking tube 61 is movably disposed in the cavity of the outer sheath handle 1 along the axial direction, and the inner sheath tube assembly 5 is inserted into the first locking tube 61 .
  • the second locking tube 62 is fixed in the axial direction and rotatably connected to the sheath handle 1 in the circumferential direction.
  • the second locking tube 62 is used to drive the first locking tube 61 relative to the second locking tube 62 along the first direction.
  • the locking tube 61 moves relative to the axial direction.
  • the outer periphery of the second locking tube 62 may be provided with two first limiting portions spaced apart along the axial direction, and the inner wall of the cavity of the outer sheath handle 1 may be provided with two first limiting portions spaced apart along the axial direction.
  • the two second limiting parts respectively block the two first limiting parts, so that the two second limiting parts limit the axial displacement of the second locking tube 62 .
  • the extrusion piece 63 is provided on the first locking tube 61 , the second locking tube 62 or the sheath handle 1 .
  • the clamping member 64 is provided on the first locking tube 61 and/or the second locking tube 62.
  • the first locking tube 61 is driven along the first locking direction relative to the second locking tube 62.
  • the clamping member 64 is extruded by the extruding member 63 at least in the radial direction to deform and clamp the inner sheath assembly 5 .
  • the second locking tube 62 is sleeved on the periphery of the first locking tube 61, the clamping member 64 is provided at the proximal end of the first locking tube 61, and the extrusion member 63 is provided at the second locking tube 61.
  • the clamping member 64 and the extruding member 63 When the clamping member 64 and the extruding member 63 are in contact, the clamping member 64 is extruded by the extruding member 63 at least in the radial direction to deform and clamp the inner sheath assembly 5 . Further, the clamping member 64 and the first locking tube 61 are integrally formed, and the extrusion member 63 and the second locking tube 62 are integrally formed. It can be understood that in modified embodiments, the clamping member 64 and the first locking tube 61 may not be integrally formed, such as a fixed connection or a detachable connection; the extrusion member 63 and the second locking tube 62 may not be integrally formed. , such as fixed connection or detachable connection.
  • the extruding member 63 may also be disposed on the outer sheath handle 1 .
  • the clamping member 64 is disposed at the distal end of the first locking tube 61 , and the extruding member 63 protrudes from the inner wall surface of the cavity of the outer sheath handle 1 .
  • the first locking tube 61 can be driven to move toward the distal end along the axial direction of the first locking tube 61 relative to the second locking tube 62, so that the clamping member 64 gradually comes closer to the squeeze tube.
  • the pressing part 63 is pressed until the clamping part 64 and the extruding part 63 contact, the clamping part 64 is extruded by the extruding part 63 at least in the radial direction to deform and clamp the inner sheath assembly 5 .
  • the clamping member 64 may be provided on the second locking tube 62 and the extruding member 63 may be provided on the first locking tube 61 .
  • the first locking tube 61 is sleeved on the outer periphery of the second locking tube 62 .
  • the second locking tube 62 rotates, it can drive the first locking tube 61 to move in the axial direction, and finally the clamping member 64 is extruded by the extrusion member 63 at least in the radial direction to deform and clamp the inner sheath assembly 5 .
  • the pressing member 63 may be disposed on the distal end of the first locking tube 61 .
  • the clamping member 64 is detachably connected between the first locking tube 61 and the second locking tube 62 , and the first locking tube 61 and the second locking tube 62 are integrally formed. There is an extrusion 63 .
  • the first locking tube 61 and the second lock The 62-phase tightening tube is screwed together. Part of the clamping member 64 extends into the first locking tube 61 , and part of the clamping member 64 extends into the second locking tube 62 .
  • the clamping member 64 has perforations extending through its proximal and distal ends, and the inner sheath assembly 5 is threaded through the perforations.
  • the clamping member 64 is moved by the first locking tube 61 and the second locking tube 62
  • the extrusion members 63 are extruded together, so that the clamping member 64 is extruded by the extrusion member 63 at least in the radial direction to deform and clamp the inner sheath assembly 5 .
  • the clamping member 64 can be made of elastic material. Further, the clamping member 64 is an elastic member that elastically bends and deforms in the radial direction when being squeezed in the radial direction.
  • the elastic member is made of rubber, for example, but is not limited thereto.
  • the clamping member 64 can also be made of copper material, which can improve the wear resistance of the clamping member 64 .
  • clamping member 64 can be integrally provided on the first locking tube 61 , and the clamping member 64 can be integrally provided on the second locking tube 62 .
  • the clamping member 64 is integrally disposed on the proximal end of the first locking tube 61
  • the clamping member 64 is integrally disposed on the distal end of the second locking tube 62 .
  • the extrusion piece 63 can be integrally disposed on the first locking tube 61 , the extrusion piece 63 can be integrally disposed on the second locking tube 62 , and the extrusion piece 63 can also be integrally disposed on the outer sheath handle 1 .
  • clamping member 64 can also be detachably connected to the first locking tube 61 or the second locking tube 62 .
  • the extrusion piece 63 can also be detachably connected to the first locking tube 61 , the second locking tube 62 or the sheath handle 1 .
  • the first locking tube 61 and the second locking tube 62 may be threaded.
  • the first locking tube 61 has an external thread
  • the second locking tube 62 has an internal thread.
  • the second locking tube 62 is sleeved on the outer periphery of the first locking tube 61 and is threadedly connected.
  • the first locking tube 61 has internal threads
  • the second locking tube 62 has external threads.
  • the first locking tube 61 is sleeved on the outer periphery of the second locking tube 62 and is threadedly connected.
  • the first locking tube 61 and the second locking tube 62 are slidingly connected to the guide rail through inclined guide grooves.
  • the second locking tube 62 includes a first tube section 621 , and the first locking tube 61 passes through the first tube section 621 .
  • the inner wall of the first pipe section 621 may have internal threads, and the outer periphery of the first locking pipe 61 may have external threads.
  • the first locking pipe 61 penetrates the first pipe section 621 and is threadedly connected to the first pipe section 621 .
  • the extrusion piece 63 is disposed at the proximal end of the first tube section 621 and extends obliquely toward the axial direction of the second locking tube 62. That is, the proximal end of the extrusion piece 63 extends toward the internal space of the second locking tube 62, or squeezes.
  • the pressing member 63 is inclined, and the proximal portion of the pressing member 63 is closer to the axis of the second locking tube 62 than its distal portion.
  • the clamping part 64 is extruded by the extrusion part 63 and at least Deformation occurs in the radial direction, thereby clamping the inner sheath assembly 5 .
  • the inner wall surface of the extruded piece 63 has a first sliding surface 631.
  • the radial size of the proximal end of the first sliding surface 631 is smaller than the radial size of the distal end. That is, the proximal part of the first sliding surface 631 is Collected, it is used for slidingly fitting with the proximal end of the clamping member 64 and pressing the clamping member 64 at least in the radial direction.
  • the radial size of the first sliding surface 631 gradually decreases from the distal end to the proximal end, so that the clamping member 64 can achieve a better sliding fit with the first sliding surface 631. Between the clamping member 64 and the proximal end, During the sliding fit of the extrusion part 63, the clamping part 64 is deformed at least in the radial direction.
  • the design in which the radial size of the first sliding surface 631 gradually decreases is more conducive to the deformation of the clamping member 64 in the radial direction.
  • the first sliding surface 631 is a tapered surface or a cambered surface.
  • the proximal end of the clamping member 64 has a second sliding surface 641.
  • the second sliding surface 641 is used to slidingly cooperate with the first sliding surface 631, so that the first sliding surface 631 can squeeze the second sliding surface 641 at least in the radial direction.
  • the clamping member 64 is deformed to clamp the inner sheath assembly 5 .
  • first sliding surface 631 and the second sliding surface 641 may be flat or curved.
  • first sliding surface 631 and the second sliding surface 641 may both be flat or curved, or one may be flat and the other may be curved.
  • both the first sliding surface 631 and the second sliding surface 641 are tapered surfaces.
  • the first sliding surface 631 and the second sliding surface 641 are disengaged from each other, and the second sliding surface 641 moves to the proximal end or proximal side of the first sliding surface 631 . In some embodiments, in the locked state, the first sliding surface 631 and the second sliding surface 641 abut each other.
  • the second locking tube 62 also includes a second tube section 622 , and the second tube section 622 is connected to the proximal end of the extrusion piece 63 . That is to say, from the distal end to the proximal end, the second locking tube 62 includes the first tube section 621, the extrusion piece 63 and the second tube section 622 in sequence.
  • the locking member 6 further includes a knob 65 , which is fixedly connected to the second locking tube 62 and exposed on the outer sheath handle 1 . The knob 65 is exposed on the outer sheath handle 1 and is used to receive the operator's circumferential rotation operation.
  • the proximal end of the first locking tube 61 is provided with a clamping member 64, and the distal end of the first locking tube 61 is provided with a limiting portion 611.
  • the limiting portion 611 is cylindrical to facilitate insertion.
  • the sheath assembly 5 is passed through.
  • the limiting portion 611 is in the shape of a square frame in a cross section perpendicular to the axial direction, and includes a top wall and a bottom wall that are opposite to each other, and two side walls that are opposite to each other and are connected between the top wall and the bottom wall.
  • the two side walls are used to limitly cooperate with the outer sheath handle 1, so that the first locking tube 61 can only move along its axial direction, but cannot rotate in the circumferential direction.
  • the top wall and the bottom wall are used to limitly cooperate with the outer sheath handle 1 so that the first locking tube 61 can only move along its axial direction but cannot rotate in the circumferential direction.
  • the clamping member 64 is provided at the proximal end of the first locking tube 61 and includes a plurality of clamping claws 642 spaced apart along the circumferential direction. There is a gap between two adjacent clamping claws 642 along the circumferential direction. Under the extrusion of the extrusion member 63 , the proximal ends of the plurality of clamping claws 642 deform and move closer to each other to clamp the inner sheath assembly 5 .
  • the above-mentioned second sliding surface 641 is provided outside the proximal end of each clamping claw 642 .
  • FIG. 9 shows a partial cross-sectional view of the outer sheath member 100 according to the embodiment of the present application.
  • the outer sheath handle 1 includes an outer handle housing 11 and a first liquid injection joint 12.
  • the outer handle housing 11 surrounds a cavity of the outer sheath handle 1.
  • the first liquid injection joint 12 is arranged in the cavity of the outer sheath handle 1, and Communicated with the proximal end of the outer sheath assembly 2.
  • the outer handle housing 11 includes an outer sheath interface portion 111.
  • the outer sheath interface portion 111 is formed with a first opening 112.
  • the cavity in the outer sheath handle 1 extends to the outer sheath interface portion 111 and penetrates to the first opening 112.
  • the injection connector 12 is provided in the outer sheath interface portion 111 and is exposed on the surface of the outer handle housing 11 through the first opening 112 for connecting with the first injection device (not shown in the figure).
  • the first injection device passes through the first injection device.
  • a filling connector 12 supplies liquid to the outer sheath assembly 2 . It can be understood that the liquid provided by the first injection device includes but is not limited to physiological saline, contrast agent, or other drugs.
  • the outer sheath handle 1 also includes a first conductive connector 13.
  • the first conductive connector 13 is provided in the cavity of the outer sheath handle 1, specifically in the outer sheath interface portion 111, and is electrically connected to the outer sheath tube assembly 2.
  • the conductive connector 13 passes through the end surface of the sheath interface portion 111 provided with the first opening 112 and is exposed on the surface of the sheath handle 1 for connection with a first external power supply (not shown in the figure).
  • the first external power supply passes through the first
  • the conductive connector 13 provides electrical energy to the outer sheath assembly 2 . It can be understood that the electrical energy provided by the first external power source can be transferred to the first connection member 83 of the implantable device 8 .
  • the outer sheath interface portion 111 is protruding from the outer wall of the outer handle housing 11 .
  • the first opening 112 is provided at an end of the outer sheath interface portion 111 away from the outer handle housing 11 .
  • the protruding direction of the outer sheath interface portion 111 is relative to the outer handle housing.
  • the axis of the body 11 is tilted with the first opening 112 towards the proximal end of the outer handle housing 11 .
  • the outer sheath interface portion 111 is protruding from the outer wall of the outer handle housing 11 , which can alleviate the problem of insufficient cavity volume of the outer sheath handle 1 .
  • the outer sheath interface portion 111 is inclined relative to the axis of the outer handle housing 11 , and the end surface of the outer sheath interface portion 111 for disposing the first opening 112 and the first conductive joint 13 faces the proximal end of the outer handle housing 11 , which makes it convenient for the operator to plug in the first injection device and the first external power supply.
  • FIG. 10 shows a schematic diagram of the first liquid injection joint 12 according to the embodiment of the present application.
  • FIG. 11 shows an exploded schematic view of the first liquid injection joint 12 according to the embodiment of the present application.
  • Figure 12 shows a cross-sectional view of the first liquid injection joint 12 according to the embodiment of the present application.
  • the first liquid injection joint 12 in the embodiment of the present application includes a valve body 14 and an opening and closing assembly 15.
  • the valve The body 14 forms a receiving channel 141 and a fluid channel 142.
  • the receiving channel 141 is connected with the first opening 112 for receiving the injection end of the first injection device.
  • the fluid channel 142 is connected with the outer sheath assembly 2 .
  • the opening and closing component 15 is formed with a cutout 151.
  • the cutout 151 runs through two opposite sides of the opening and closing component 15 in the thickness direction.
  • the opening and closing component 15 is provided between the receiving channel 141 and the fluid channel 142.
  • the injection end of the first injection device is Enter the fluid channel 142 through the cutout 151 along the receiving channel 141, and inject liquid into the fluid channel 142.
  • the liquid flows through the fluid channel 142 and enters the inner cavity of the outer sheath assembly 2.
  • the first injection connector 12 of the embodiment of the present application is disposed in the cavity of the sheath handle 1, and the receiving channel 141 of the first injection connector 12 can receive the injection end of the first injection device, and the injection end can be along the
  • the receiving channel 141 passes through the cutout 151 and enters the fluid channel 142, so that the liquid of the first injection device enters the fluid channel 142 along the receiving channel 141 through the cutout 151, and finally enters the inner cavity of the outer sheath assembly 2.
  • the first liquid injection connector 12 of this embodiment is integrated into the outer sheath handle 1, which on the one hand improves the integration of the outer sheath handle 1 On the other hand, it also facilitates the circumferential rotation and axial movement of the outer sheath member 100.
  • the opening and closing assembly 15 includes an elastic gasket 15a, and the gasket 15a is formed with a cutout 151.
  • the cutout 151 may be in a "X" shape.
  • the cutout 151 is opened, and the liquid flowing out of the injection end can flow out of the first liquid injection connector 12 through the fluid channel 142 .
  • the cutout 151 is closed in a natural state, and the receiving channel 141 and the fluid channel 142 are isolated by the gasket 15a.
  • the first liquid injection connector 12 can receive liquid from the first injection device.
  • the receiving channel 141 and the fluid channel 142 are isolated by the gasket 15a to ensure the sealing of the inner cavity of the outer sheath member 100 and prevent outside air from entering the inner cavity of the outer sheath assembly 2 from the first injection connector 12.
  • the valve body 14 includes a first seat body 143 and a second seat body 144.
  • the first seat body 143 and the second seat body 144 are detachably connected.
  • the first seat 143 is formed with a receiving channel 141.
  • the second seat 144 includes a channel portion 145 and a connecting portion 146 that are connected to each other.
  • the connecting portion 146 is detachably connected to the first seat 143.
  • the channel portion 145 and the connecting portion 146 form a receiving channel 141.
  • the opening and closing assembly 15 is sandwiched between the first base 143 and the second base 144 .
  • the connecting part 146 and the first base 143 may be connected through threads.
  • the outer periphery of the connecting part 146 has external threads
  • the inner wall of the first base 143 has external threads.
  • the connecting portion 146 can also be sleeved on the outer periphery of the first base 143 .
  • the connecting portion 146 and the first base body 143 are not limited to being connected through threads, but may be connected through at least one method such as snapping, bonding, or the like.
  • the position of the connecting portion 146 facing the receiving channel 141 forms an accommodating groove 147 that is concave in a direction away from the receiving channel 141.
  • the opening and closing assembly 15 covers the opening of the accommodating groove 147.
  • the accommodating groove 147 is used to accommodate the injection end of the first injection device.
  • the bottom surface of 147 forms an abutment surface 1471 for abutting the injection end.
  • the receiving channel 141 is an equal-diameter channel
  • the fluid channel 142 is an equal-diameter channel.
  • the equal-diameter channel is, and the radial dimensions are the same at different axial positions of the channel.
  • the injection end of the first injection device can pass through the receiving channel 141 and the fluid channel 142 against the abutment surface 1471.
  • the radial dimensions of the receiving channel 141 and the fluid channel 142 may be the same or different.
  • the injection end of the first injection device After the injection end of the first injection device is inserted into the first liquid injection connector 12, the injection end can abut against the abutting surface 1471 of the receiving groove 147 after passing through the cutout 151. When the injection end abuts against the abutting surface 1471, the operator Then you know that the injection end has been inserted into place, which improves the operator's operating feel.
  • Figure 13 shows a schematic diagram of the second base body 144 according to the embodiment of the present application.
  • the contact surface 1471 is formed with a guide groove 148 that is recessed in a direction away from the opening and closing assembly 15 , and the guide groove 148 is connected with the fluid channel 142 .
  • the guide groove 148 facilitates the flow of liquid and prevents the abutment surface 1471 from blocking the flow of liquid into the fluid channel 142 .
  • the shape of the guide groove 148 may be a "ten" shape, but is not limited to this.
  • Figure 14 shows a schematic diagram of the two ends of the connecting tube 17 connected to the outer sheath connector 16 and the first liquid injection connector 12 respectively according to the embodiment of the present application.
  • the outer sheath handle 1 also includes an outer sheath connector 16 and a connecting tube 17 .
  • the outer sheath joint 16 is disposed in the cavity of the outer handle housing 11 and is generally tubular in shape.
  • the outer sheath connector 16 has a main channel 161 and a branch channel 162 that communicate with each other.
  • the proximal end of the outer sheath assembly 2 is connected to the distal end of the outer sheath connector 16 and communicates with the main channel 161.
  • the inner sheath assembly 5 is passed through the main channel 161. In the channel 161, and passing out from both ends of the main channel 161.
  • One end of the connecting tube 17 is connected to the fluid channel 142 , and the other end is connected to the branch channel 162 .
  • the outer sheath connector 16 includes a tip 167 , a middle piece 168 and a base 169 . From the distal end to the proximal end, the end 167, the middle piece 168 and the base 169 are detachably connected in sequence. For example, the end 167 is threadedly connected to one end of the middle piece 168, and the other end of the middle piece 168 is threaded to the base 169.
  • the proximal end of the outer sheath tube 21 is fixedly connected in the outer sheath connector 16 .
  • the proximal end of the outer sheath hose 21 is fixed between the end 167 and the middle piece 168.
  • the outer sheath hose 21 is fixed between the end 167 and the middle piece 168.
  • the proximal end of 21 is inserted into the perforation of the proximal end of end 167, and the proximal end of outer sheath hose 21 is expanded, so that the proximal end of outer sheath hose 21 is deformed into a cone shape and connected with end 167
  • the shape of the hole wall of the proximal end of the perforated hole is matched, and then the middle piece 168 is assembled with the end head 167, so that the proximal end of the cone-shaped outer sheath hose 21 is clamped on the perforated hole wall of the end head 167. and the remote end of middleware 168.
  • the outer sheath connector 16 further includes an elastic sealing member 165 .
  • the sealing member 165 is disposed at the proximal end of the outer sheath connector 16 , for example, is sandwiched between the proximal end of the intermediate member 168 and the base 169 .
  • the seal 165 is provided with an opening 166 in the axial direction for the inner sheath assembly 5 to pass through.
  • the opening 166 allows the reinforcing tube 54 and the inner sheath hose 51 to pass through.
  • the outer sheath connector 16 is used to communicate with the first liquid injection connector 12 and the outer sheath tube assembly 2, and a sealing member 165 is provided to seal the proximal end of the outer sheath connector 16.
  • end 167 and the middle piece 168 are designed as detachable separate structures to facilitate the assembly of the proximal end of the sheath tube 21 .
  • the middle piece 168 and the base 169 are designed as detachable split structures to facilitate the assembly of the seal 165 .
  • the outer sheath connector 16 includes a main tube 163 and a branch tube 164.
  • the main conduit 163 forms a main channel 161 , the distal end of the main conduit 163 is connected to the proximal end of the outer sheath tube 21 , and the main channel 161 is connected with the inner cavity of the outer sheath tube 21 for threading the inner sheath tube assembly 5 .
  • the branch pipe 164 forms a branch channel 162, and the branch channel 162 is connected to the main channel 161. 9, 14 and 16, the channel part 145 of the first liquid injection joint 12 is located on one side of the axis of the main pipe 163, and the branch pipe 164 is adjacent to the channel opening of the main pipe 163 adjacent to the channel part 145. one side of the pipe wall.
  • the axis of the branch pipe 164 and the axis of the main pipe 163 may be inclined to each other, or may be perpendicular to each other.
  • the branch pipe 164 and the main pipe 163 have a Y-shaped structure
  • the axis of the branch pipe 164 is inclined to the axis of the main pipe 163
  • the branch pipe 164 is away from one end of the main pipe 163 Extending toward the proximal end of the main conduit 163.
  • the opposite ends of the connecting pipe 17 are respectively connected to the channel opening of the channel portion 145 and the one end opening of the branch pipe 164 away from the main pipe 163 .
  • the axis of the branch pipe 164 is inclined to the axis of the main pipe 163 and the branch pipe 164 extends toward the proximal end of the main pipe 163, the two ends of the connecting pipe 17 are connected to the branch pipe 164 and the first liquid injection joint 12 respectively. After the passage portion 145 is formed, it is beneficial to increase the distance between the two ends of the connecting pipe 17 and reduce the curvature and length of the connecting pipe 17 .
  • the liquid provided by the first injection device sequentially flows through the first liquid injection connector 12, the connecting tube 17, the branch pipe 164, the main pipe 163, the proximal end of the outer sheath assembly 2, and up to the distal end of the outer sheath assembly 2.
  • the main conduit 163 of the outer sheath connector 16 may be formed by the end 167 , the middle piece 168 and the base 169 , and the branch pipe 164 may be formed in the middle piece 168 .
  • the axis of the fluid channel 142 and the axis of the receiving channel 141 are staggered from each other, so that the outer wall of the channel portion 145 forms an escape recessed in the direction of the axis of the fluid channel 142 relative to the outer wall of the connecting portion 146.
  • the outer sheath connector 16 and/or the outer sheath tube assembly 2 pass through the avoidance space 149 to prevent the channel portion 145 from interfering with the outer sheath connector 16 and/or the outer sheath tube assembly 2 .
  • the outer walls of the channel portion 145 and the connecting portion 146 jointly form a large avoidance space 149.
  • This avoidance space 149 is used for the outer sheath connector 16 and/or the outer sheath tube assembly 2 to pass through, which can further improve the integration of the outer sheath handle 1, effectively utilize the volume in the outer handle housing 11, and reduce the size of the outer sheath handle 1 size; on the other hand, the channel portion 145 of the first liquid injection joint 12 is far away from the outlet of the branch pipe 164 of the outer sheath joint 16 (that is, the pipe mouth of one end of the branch pipe 164 away from the main pipe 163), so that the connecting pipe 17 can be adjusted bending curvature and length.
  • the outer sheath handle 1 also includes a positioning structure 18.
  • the positioning structure 18 is arranged on the inner wall of the cavity of the outer sheath handle 1 and is located at the proximal end of the outer sheath handle 1 to position the connecting tube 17 on the outer sheath.
  • the positioning structure 18 may include a positioning post 181 and a positioning frame 182 .
  • the positioning frame 182 is closer to the proximal end than the positioning post 181 .
  • a section of the connecting tube 17 (the middle part in the figure) is positioned between the positioning post 181 and the positioning frame 182 .
  • the positioning frame 182 extends from the inner wall of the outer handle housing 11 to the inside of the outer handle housing 11, and also forms a positioning cavity 183.
  • the positioning cavity 183 is in a square frame shape and is used to limit the first locking tube.
  • the limiting portion 611 of the first locking tube 61 is disposed in the positioning cavity 183.
  • the limiting portion 611 can only move along the axial direction relative to the positioning frame 182, but cannot rotate circumferentially.
  • FIG. 15 shows a partial cross-sectional view of the inner sheath member 200 according to the embodiment of the present application.
  • the inner sheath handle 4 includes an inner handle housing 41 and a second liquid injection connector 42 .
  • the second liquid injection connector 42 is disposed in the inner handle housing 41 and communicates with the proximal end of the inner sheath tube assembly 5 .
  • the inner handle housing 41 includes an inner sheath interface portion 411.
  • the inner sheath interface portion 411 is formed with a second opening 412.
  • the second opening 412 is used to realize the connection between the second injection connector 42 and the second injection device (not shown in the figure).
  • the second injection device is used to provide liquid to the inner sheath assembly 5.
  • the liquid provided by the second injection device includes but is not limited to physiological saline, contrast agent, or other drugs.
  • the second injection device can be connected to the second injection joint 42 through a three-way valve 44 , one of the valve ports of the three-way valve 44 is connected to a pipeline, and the pipeline is away from one end of the three-way valve 44 It penetrates into the inner handle housing 41 through the second opening 412 to connect with the second liquid injection connector 42 (specifically, it is connected to the second channel 422 of the second liquid injection connector 42, which will be described in detail later).
  • the inner sheath handle 4 also includes a tubular guide wire opening 45 , which is connected with the inner cavity of the inner sheath tube assembly 5 .
  • One end of the guide wire port 45 is exposed on the surface of the inner sheath handle 4 , and through the guide wire port 45 , the guide wire can pass through the guide wire port 45 and enter the inner cavity of the inner sheath tube assembly 5 .
  • the second liquid injection connector 42 includes a first channel 421 and a second channel 422 that are connected.
  • the proximal end of the first channel 421 is connected to the guidewire port 45 , and the distal end of the first channel 421 is connected to the inner cavity of the inner sheath assembly 5 .
  • the proximal end of the second channel 422 is used to communicate with the second injection device, and the distal end of the second channel 422 is connected to the first channel 421.
  • the axis of the first channel 421 and the axis of the second channel 422 are arranged obliquely, and the proximal end of the second channel 422 extends toward the proximal end of the first channel 421 .
  • the inner sheath handle 4 also includes a second conductive joint 43.
  • the second conductive joint 43 is arranged in the inner handle housing 41 and is electrically connected to the inner sheath tube assembly 5.
  • the second conductive joint 43 passes through the inner sheath interface portion 411 and is provided with The end surface of the second opening 412 is exposed on the surface of the inner sheath handle 4 for connection with a second external power source (not shown in the figure).
  • the second external power source provides electrical energy to the inner sheath assembly 5 through the second conductive connector 43 .
  • the inner sheath tube assembly 5 includes an inner sheath hose 51, a reinforcing tube 54 and a guide sleeve 53.
  • the inner sheath hose 51 is threaded through the outer sheath member 100 .
  • the inner sheath hose 51 is threaded through the outer sheath tube assembly 2 , the outer sheath connector 16 and the locking member 6 .
  • the distal end of the inner sheath hose 51 extends out of the distal end of the outer sheath assembly 2 and is connected to the second connector 84 of the implantable device 8, and the proximal end of the inner sheath hose 51 extends out of the proximal end of the outer sheath handle 1, And connected with the inner sheath handle 4.
  • the proximal end of the sheath hose 51 extends into the inner handle housing 41 and is connected to the second liquid injection connector 42 .
  • the reinforcing tube 54 is sleeved on the outer periphery of the inner sheath hose 51 and is used to be inserted into the outer sheath connector 16 of the outer sheath member 100 .
  • the distal end of the reinforcing tube 54 extends out of the sheath handle 1, and the proximal end of the reinforcing tube 54 is connected to the guide sleeve 53.
  • the guide sleeve 53 is inserted into the locking member 6 of the outer sheath member 100 .
  • the guide sleeve 53 is inserted into the first locking tube 61 and the second locking tube 62 of the locking member 6 .
  • the clamping member 64 is used to clamp the outer periphery of the guide sleeve 53 .
  • the distal end of the guide sleeve 53 extends to the inner cavity of the outer sheath handle 1, and is set on the proximal periphery of the reinforcing tube 54 , the proximal end of the guide sleeve 53 extends out of the proximal end of the outer sheath handle 1 and is connected with the inner handle housing 41 .
  • the hardness of the guide sleeve 53 is greater than the hardness of the inner sheath hose 51 . Since the clamping member 64 clamps the guide sleeve 53 with higher hardness but does not clamp the inner sheath hose 51 with lower hardness, the guide sleeve 53 can protect the inner sheath hose 51 and prevent the inner sheath hose 51 from being clamped and deformed. , which affects the flow of internal liquid.
  • the hardness of the reinforcing tube 54 is greater than the hardness of the inner sheath hose 51.
  • the distal end of the guide sleeve 53 is set on the proximal periphery of the reinforcing tube 54, which facilitates the torque on one side of the inner sheath handle 4 to be transmitted to the relatively poor hardness.
  • Inner sheath hose 51 is set on the proximal periphery of the reinforcing tube 54, which facilitates the torque on one side of the inner sheath handle 4 to be transmitted to the relatively poor hardness.
  • the reinforcing tube 54 and the inner sheath hose 51 both pass through the opening 166 of the seal 165 of the outer sheath connector 16. Since the reinforcing tube 54 is sleeved on the outer periphery of the inner sheath hose 51, the outer wall of the reinforcing tube 54 is in contact with the seal. 165 direct contact.
  • the hardness of the reinforcing tube 54 is higher than that of the inner sheath hose 51, so that the material hardness of the position where the inner sheath tube assembly 5 penetrates the outer sheath connector 16 is strengthened.
  • the reinforcing tube 54 plays a role in protecting the inner sheath hose 51. This prevents the seal 165 from compressing the inner sheath hose 51, damaging the structure of the inner sheath hose 51, and affecting the axial movement and circumferential rotation of the inner sheath hose 51, as well as the liquid transmission inside it.
  • connection can be a fixed connection, a detachable connection, or an integral connection; “connection” can be Either directly or indirectly through an intermediary.
  • connection can be Either directly or indirectly through an intermediary.

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Abstract

本申请提供输送装置以及包括所述输送装置的医疗器械系统，输送装置包括外鞘构件和内鞘构件。外鞘构件包括外鞘手柄和至少部分设置于外鞘手柄远侧的外鞘管组件，外鞘手柄和外鞘管组件均在各自的近端与远端之间形成空腔，两个空腔相连通；外鞘手柄用于供操作者操作，以带动外鞘管组件运动，外鞘管组件的远端用于与可植入装置可拆卸连接；内鞘构件包括内鞘手柄以及至少部分设置于内鞘手柄远侧的内鞘管组件，内鞘管组件用于穿设于两空腔，且内鞘管组件的远端用于与可植入装置可拆卸连接，至少部分内鞘手柄外露于外鞘手柄，内鞘手柄用于供操作者操作，以带动内鞘管组件运动。

Description

输送装置及医疗器械系统
本申请要求2022年04月28日提交至中国专利局、申请号为202210462159X、申请名称为“输送装置及医疗器械系统”的中国专利申请的优先权，同时要求2022年04月28日提交至中国专利局、申请号为2022210183691、申请名称为“输送装置及医疗器械系统”的中国专利申请的优先权，其全部内容通过引用结合在本申请中。
技术领域
本申请涉及医疗器械技术领域，具体而言，涉及一种输送装置及医疗器械系统。
背景技术
经皮介入疗法是近年来发展非常迅速的疾病治疗手段，并且该疗法适用的领域也越来越广泛。其中采用经导管介入治疗方法可以放置器械和/或药物到人体的心脏、动静脉血管等部位。
相关技术中的部分可植入装置，具有两个在轴向间隔设置的连接件，可植入装置在患者体内释放后，输送装置的鞘管需要与两个连接件依次解脱。
然而，相关技术中的输送装置在输送以及释放可植入装置的过程中，每个鞘管的不同运动方式分别需要一套控制组件来驱动，导致具有多连接件的可植入装置配套的输送装置整体结构复杂，输送装置组装工艺繁琐，无形中提高了成本。
发明内容
本申请实施方式提供一种能够简化手柄结构的输送装置，以解决相关技术中存在的问题。
为实现上述目的，一方面，本申请提供一种输送装置，包括外鞘构件和内鞘构件，所述外鞘构件包括外鞘手柄和至少部分设置于所述外鞘手柄远侧的外鞘管组件，所述外鞘手柄和所述外鞘管组件均在各自的近端与远端之间形成空腔，两个所述空腔相连通；所述外鞘手柄用于供操作者操作，以带动所述外鞘管组件运动，所述外鞘管组件的远端用于与可植入装置可拆卸连接；所述内鞘构件包括内鞘手柄以及至少部分设置于所述内鞘手柄远侧的内鞘管组件，所述内鞘管组件用于穿设于两所述空腔，且所述内鞘管组件的远端用于与所述可植入装置可拆卸连接，至少部分所述内鞘手柄外露于所述外鞘手柄，所述内鞘手柄用于供操作者操作，以带动所述内鞘管组件运动。
另一方面，本申请提供一种医疗器械系统，包括可植入装置和上述的输送装置，可植入装置包括相互间隔设置的第一连接件与第二连接件；所述外鞘管组件的远端用于与所述第一连接件可拆卸连接，所述内鞘管组件的远端用于与所述第二连接件可拆卸连接；所述输送装置用于将所述可植入装置输送并释放至患者体内。
本申请实施方式提供的输送装置及医疗器械系统中，所述输送装置包括外鞘构件和内鞘构件，外鞘构件包括外鞘手柄以及与外鞘手柄连接的外鞘管组件，内鞘构件包括内鞘手柄以及与内鞘手柄连接的内鞘管组件。外鞘手柄可供操作者操作，以带动外鞘管组件运动；至少 部分内鞘手柄外露于外鞘手柄，内鞘手柄可供操作者操作，以带动内鞘管组件运动，进而操作者可直接单独操作内鞘手柄与外鞘手柄中的任意一个，从而可以带动内鞘管组件以及外鞘管组件实现相对运动，简化了输送装置的内部驱动结构，并且方便操作者操作。
附图说明
图1示出的是本申请实施例的医疗器械系统的示意图。
图2示出的是本申请实施例的可植入装置的示意图。
图3示出的是本申请实施例的输送装置的示意图。
图4示出的是本申请实施例的外鞘构件的示意图。
图5示出的是本申请实施例的内鞘构件的示意图。
图6示出的是图3所示输送装置沿I-I线的局部剖视图。
图7示出的是本申请实施例的锁紧构件的示意图。
图8示出的是本申请实施例的锁紧构件的剖视图。
图9示出的是图4所示外鞘构件沿I I-I I线的局部剖视图。
图10示出的是本申请实施例的第一注液接头的示意图。
图11示出的是本申请实施例的第一注液接头的分解示意图。
图12示出的是本申请实施例的第一注液接头的剖视图。
图13示出的是本申请实施例的第二座体的示意图。
图14示出的是本申请实施例的连接管的两端分别连接外鞘接头和第一注液接头的示意图。
图15示出的是本申请实施例的内鞘构件的局部剖视图。
图16示出的是图9中A处的局部放大图。
其中，附图标记说明如下：
10、输送装置；100、外鞘构件；200、内鞘构件；1、外鞘手柄；11、外手柄壳体；111、
外鞘接口部；112、第一开口；12、第一注液接头；13、第一导电接头；14、阀体；141、接收通道；142、流体通道；143、第一座体；144、第二座体；145、通道部；146、连接部；147、容纳槽；1471、抵接面；148、导流槽；149、避让空间；15、启闭组件；15a、垫片；151、切口；16、外鞘接头；161、主通道；162、支通道；163、主管道；164、支管道；165、密封件；166、开孔；167、端头；168、中间件；169、底座；17、连接管；18、定位结构；181、定位柱；182、定位框；183、定位腔；2、外鞘管组件；21、外鞘软管；22、外导电头；4、内鞘手柄；41、内手柄壳体；411、内鞘接口部；412、第二开口；42、第二注液接头；421、第一通道；422、第二通道；43、第二导电接头；44、三通阀；45、导丝口；5、内鞘管组件；51、内鞘软管；52、内导电头；53、导套；54、加强管；6、锁紧构件；61、第一锁紧管；611、限位部；62、第二锁紧管；621、第一管段；622、第二管段；63、挤压件；631、第一滑动面；64、夹持件；641、第二滑动面；642、夹爪；65、旋钮；7、装载器；8、可植入装置；81、密封盘；82、锚定盘；821、电极；83、第一连接件；84、第二连接件；85、第一固定件；86、第二固定件；87、第三固定件；88、可膨胀体。
具体实施方式
现在将参考附图更全面地描述示例实施方式。然而，示例实施方式能够以多种形式实施， 且不应被理解为限于在此阐述的实施方式；相反，提供这些实施方式使得本申请将全面和完整，并将示例实施方式的构思全面地传达给本领域的技术人员。图中相同的附图标记表示相同或类似的结构，因而将省略它们的详细描述。
如图1所示，图1示出的是本申请实施例的医疗器械系统的示意图。本申请实施例的医疗器械系统包括输送装置10、可植入装置8和装载器7。输送装置10用于通过介入治疗的方式将可植入装置8输送并植入至患者体内。装载器7套设在输送装置10的外围，用于将可植入装置8载入输送装置10。
可以理解的是，本申请实施例中的术语“包括”和“具有”以及它们任何变形，意图在于覆盖不排他的包含。例如包含了一系列步骤或单元的过程、方法、系统、产品或设备没有限定于已列出的步骤或单元，而是可选地还包括没有列出的步骤或单元，或可选地还包括对于这些过程、方法、产品或设备固有的其它步骤或组件。
可植入装置8可以是心脏封堵器、血管封堵器、血管滤器等类型。本申请中以可植入装置8为左心耳封堵器为例进行说明，可以理解的是，可植入装置8还可以是其他类型可植入装置。
如图2所示，图2示出的是本申请实施例的可植入装置8的示意图。作为一示例，可植入装置8为左心耳封堵器，包括可膨胀体88以及设置于可膨胀体88上的第一连接件83和第二连接件84。第一连接件83和第二连接件84在可植入装置8的轴向方向上间隔设置，且用于与输送装置10连接。例如，第一连接件83与输送装置10的外鞘管组件2的远端可拆卸连接，第二连接件84与输送装置10的内鞘管组件5的远端可拆卸连接，后续将详细说明。
可膨胀体88包括密封盘81和锚定盘82，密封盘81和锚定盘82在可植入装置8的轴向方向上间隔设置，并且密封盘81设置在锚定盘82的近端。第一连接件83设置在第二连接件84的近侧，具体的，第一连接件83设置在密封盘81上，第二连接件84设置在锚定盘82上。
需要说明的是，在本申请实施例中，术语“远端”、“远侧”、“近端”、“近侧”是以在手术过程中沿着输送路径相对于操作输送装置10的操作者的远近来界定。具体来说，某一部件沿着输送路径靠近操作者的一端/侧为“近端”/“近侧”，沿着输送路径远离操作者的一端/侧为“远端”/“远侧”。
作为一示例，可植入装置8被释放至左心耳口部，第一连接件83和第二连接件84分别与输送装置10解脱后，输送装置10的远端撤离体外。举例来说，第一连接件83和第二连接件84均可以与输送装置10为周向旋转解脱的连接关系，例如第一连接件83与输送装置10为螺纹连接，第二连接件84与输送装置10为螺纹连接。
当然，在一些实施方式中，第一连接件83和第二连接件84与输送装置10之间还可以是插拔解脱的连接关系。在一些实施方式中，第一连接件83与外鞘管组件2的远端间接连接，及/或第二连接件84与内鞘管组件5的远端间接连接。
在本实施方式中，密封盘81与锚定盘82可以均由导电材料制成，密封盘81采用骨架导电，第一连接件83与密封盘81骨架电连接，锚定盘82设置有用于导电的电极821，第二连接件84与锚定盘82的电极821电连接。第一连接件83与第二连接件84还都用于传输电能。
作为一示例，如图2所示，第一连接件83与第二连接件84之间还设置有多个固定件，分别为第一固定件85、第二固定件86和第三固定件87。这些固定件用于连接密封盘81与锚定盘82，并起到绝缘作用。
具体来说，密封盘81呈网状，可以由编织或切割工艺制造，第一连接件83连接于密封盘81的近端，优选地还用于收束密封盘81中编织丝的近端。第一固定件85设置于密封盘 81的远端，优选地，第一固定件85还用于收束密封盘81编织丝的远端。第一固定件85可以由导电材料制成也可以由绝缘材料制成。在一些实施方式中，密封盘81表面设置有膜体用于实现阻流、及/或绝缘等作用。膜体可以设置于密封盘81的至少部分外侧表面，及/或设置于密封盘81的至少部分内表面。
锚定盘82可以由编织工艺或切割工艺制成，锚定盘82的端部收束在一起，并压紧在第二固定件86和第三固定件87之间，第二固定件86和第三固定件87可以均由绝缘材料制成。第二连接件84设置在第三固定件87的远端，从而保证密封盘81与锚定盘82之间的绝缘，以及锚定盘82与第二连接件84之间的绝缘。在一些实施方式中，锚定盘82表面设置有膜体用于实现阻流、及/或绝缘等作用。膜体可以设置于锚定盘82的至少部分外侧表面，及/或设置于锚定盘82的至少部分内表面。
可以理解的是，上述描述仅仅以图2为示例来说明可膨胀体88，图2中可膨胀体88包括密封盘81、锚定盘82，为双盘结构。在其他实施方式中，可膨胀体88为其他结构形式，比如为单盘结构或者是三盘结构或者更多盘结构，比如可膨胀体88为单盘结构并呈柱塞状。
上述描述仅仅以图2为示例来说明密封盘81、锚定盘82之间如何实现绝缘。当然，在其他实施方式中，第一连接件83与第二连接件84之间还采用其他的方式实现绝缘。
如图3所示，图3示出的是本申请实施例的输送装置10的示意图。本申请实施例的输送装置10，包括外鞘构件100和内鞘构件200，内鞘构件200可活动地穿设于外鞘构件100内。外鞘构件100的远端能够与可植入装置8的第一连接件83可拆卸地连接。内鞘构件200的远端能够与可植入装置8的第二连接件84可拆卸地连接。
在一实施方式中，外鞘构件100的远端与第一连接件83之间可以为插拔连接或周向旋转连接。当为周向旋转连接时，可以为螺纹连接。内鞘构件200的远端与第二连接件84之间可以为插拔连接或周向旋转连接。当为周向旋转连接时，可以为螺纹连接。
如图4所示，图4示出的是本申请实施例的外鞘构件100的示意图。外鞘构件100包括外鞘手柄1和外鞘管组件2。至少部分的外鞘管组件2设置于外鞘手柄1远侧。外鞘手柄1和外鞘管组件2均在各自的近端与远端之间形成空腔，两个空腔相连通。外鞘管组件2包括外鞘软管21和外导电头22，外导电头22设置在外鞘软管21的远端，用于与第一连接件83连接。外导电头22与第一连接件83的连接方式可以为插拔连接或周向旋转连接。当操作者操作外鞘手柄1时，能够带动外鞘管组件2做同步运动。外鞘手柄1用于供操作者操作，以带动外鞘管组件2运动，例如带动外鞘管组件2产生周向旋转运动和/或轴向移动，以使外鞘构件100与可植入装置8的第一连接件83实现连接、解脱，并能够用于带动第一连接件83移动。
如图5所示，图5示出的是本申请实施例的内鞘构件200的示意图。内鞘构件200包括内鞘手柄4和内鞘管组件5。至少部分的内鞘管组件5设置于内鞘手柄4远侧，内鞘管组件5用于穿设于外鞘构件100的两空腔。内鞘手柄4用于供操作者操作，以带动内鞘管组件5做同步运动，例如带动内鞘管组件5产生周向旋转运动和/或轴向移动。内鞘管组件5包括内鞘软管51和内导电头52，内导电头52设置在内鞘软管51的远端，用于与第二连接件84连接。内导电头52与第二连接件84的连接方式可以为插拔连接或周向旋转连接。当操作者操作内鞘手柄4时，能够带动内鞘管组件5运动。
请继续参阅图3，至少部分的内鞘手柄4外露于外鞘手柄1。通过操作内鞘手柄4，可使内鞘构件200相对于外鞘构件100在周向和/或轴向上产生运动，以使内鞘构件200与可植入装置8的第二连接件84实现连接、解脱，并能够用于带动第二连接件84移动。
在本实施例中，内鞘手柄4和外鞘手柄1在轴向上间隔设置。换言之，内鞘手柄4完全显露于外鞘手柄1。通过内鞘手柄4和外鞘手柄1在轴向上间隔设置，可使内鞘手柄4和外鞘手柄1在径向上不存在重叠结构，进而减小外鞘手柄1在径向上的尺寸。另外，内鞘手柄4完全显露于外鞘手柄1，更加方便操作者操作内鞘手柄4，例如操作内鞘手柄4实现轴向移动和/或周向旋转。
外鞘手柄1以及内鞘手柄4沿轴向依次设置，用于接受操作者的操控。操作者可以一只手握持外鞘手柄1，另一只手握持内鞘手柄4，操作者可以操作内鞘手柄4相对于外鞘手柄1产生轴向或者周向上的相对运动，以控制内鞘管组件5与外鞘管组件2产生相应的相对运动。
当然，在一些实施方式中，内鞘手柄4的远端可以隐藏在外鞘手柄1内，而内鞘手柄4的近端显露于外鞘手柄1。操作者可操作内鞘手柄4的近端，从而驱动内鞘构件200沿轴向和/或周向运动。
内鞘手柄4设置在输送装置10的近端，内鞘管组件5能够在内鞘手柄4的带动下，从外鞘构件100的空腔中向近侧移动直至与外鞘构件100完全脱离。换句话说，内鞘构件200相对于外鞘构件100在轴向上能够产生不限长度的轴向移动，使得内鞘构件200能够与外鞘构件100完全脱离。通过这样的设计，更加方便后续外鞘构件100与可植入装置8的旋转解脱，避免外鞘构件100与可植入装置8的旋转解脱的过程中，外鞘手柄1需要克服其近端穿出的内鞘手柄4以及内鞘管组件5带来的阻力。
具体来说，内鞘构件200、外鞘构件100与可植入装置8解脱时，可以采用的方式是：内鞘构件200的内导电头52与第二连接件84解脱之后，直接将内鞘构件200从患者体内撤出，即内鞘构件200从外鞘构件100的近侧完全抽离外鞘构件100，与外鞘构件100完全脱离。接着再将外鞘构件100的外导电头22与第一连接件83解脱。在外鞘构件100与第一连接件83的解脱过程中，由于内鞘构件200与外鞘构件100已完全脱离，故在外鞘构件100的旋转解脱过程中，内鞘构件200并不会影响外鞘构件100的旋转运动，使得外鞘构件100的旋转解脱更加便捷。
当然，内鞘构件200能够与外鞘构件100完全脱离的优点同样适用于外鞘构件100与第一连接件83为插拔的连接方式。
在其他实施方式中，内鞘构件200、外鞘构件100与可植入装置8解脱，还可以采用如下的解脱方式：内鞘构件200的内导电头52先与第二连接件84解脱，之后再将内鞘构件200向近侧移动一段距离，避免内鞘手柄4距离外鞘手柄1太近，导致操作者不容易操作外鞘手柄1，此时内鞘构件200中的内鞘管组件5还位于外鞘构件100内部。接着再将外鞘构件100的外导电头22与第一连接件83解脱，最后内鞘构件200和外鞘构件100一同从患者体内撤出。
本申请实施例的输送装置10，包括外鞘构件100和内鞘构件200，外鞘构件100包括外鞘手柄1以及与外鞘手柄1连接的外鞘管组件2，内鞘构件200包括内鞘手柄4以及与内鞘手柄4连接的内鞘管组件5。外鞘手柄1可供操作者操作，以带动外鞘管组件2运动，内鞘手柄4可供操作者操作，以带动内鞘管组件5运动。通过至少部分内鞘手柄4外露于外鞘手柄1的设计，使得操作者可直接操作内鞘手柄4，从而单独控制内鞘管组件5的运动，进而简化了手柄结构，并且方便操作者操作。
如图6至图8所示，图6示出的是本申请实施例的输送装置10的局部剖视图。图7示出的是本申请实施例的锁紧构件6的示意图。图8示出的是本申请实施例的锁紧构件6的剖视图。输送装置10还包括锁紧构件6，锁紧构件6连接在外鞘手柄1与内鞘管组件5之间，锁 紧构件6能够在锁紧状态和解锁状态之间相互转换。在解锁状态下，外鞘构件100和内鞘构件200能够产生相对运动，在锁紧状态下，锁紧构件6产生形变并夹紧内鞘管组件5，从而阻止内鞘构件200与外鞘构件100产生相对运动。
当锁紧构件6处于锁紧状态下时，能够阻止内鞘构件200与外鞘构件100产生相对运动，在可植入装置8的输送以及释放时，能够避免操作者误操作内鞘构件200。
可以理解的是，阻止内鞘构件200与外鞘构件100的相对运动包括周向运动和轴向运动。
在一实施方式中，部分锁紧构件6设置于外鞘手柄1的空腔中，内鞘管组件5穿设于锁紧构件6。
锁紧构件6包括第一锁紧管61、第二锁紧管62、挤压件63和夹持件64。第一锁紧管61沿轴向可移动地设置在外鞘手柄1的空腔内，内鞘管组件5穿设于第一锁紧管61内。第二锁紧管62沿轴向固定且沿周向可旋转地连接于外鞘手柄1，第二锁紧管62用于带动第一锁紧管61相对于第二锁紧管62沿第一锁紧管61的轴向产生相对移动。作为一示例，第二锁紧管62的外周可以凸设有沿轴向间隔设置的两个第一限位部，外鞘手柄1的空腔的内壁设有沿轴向间隔设置的两个第二限位部，两个第二限位部分别与两个第一限位部相止挡，使得两个第二限位部限制第二锁紧管62沿轴向的位移。
挤压件63设置在第一锁紧管61、第二锁紧管62或外鞘手柄1上。夹持件64设置在第一锁紧管61和/或第二锁紧管62上，在第二锁紧管62旋转带动第一锁紧管61相对于第二锁紧管62沿第一锁紧管61的轴向产生相对移动的过程中，夹持件64至少在径向上受挤压件63挤压产生形变而夹持内鞘管组件5。
在本实施例中，第二锁紧管62套设于第一锁紧管61的外围，夹持件64设置在第一锁紧管61的近端，挤压件63设置于第二锁紧管62的内壁表面。当第二锁紧管62旋转时，能够带动第一锁紧管61相对于第二锁紧管62沿第一锁紧管61的轴向向近端移动，使得夹持件64逐渐靠近挤压件63。当夹持件64和挤压件63接触时，夹持件64至少在径向上受挤压件63挤压产生形变而夹持内鞘管组件5。进一步地，夹持件64与第一锁紧管61为一体成型，挤压件63与第二锁紧管62为一体成型。可以理解的是，在变更实施方式中，夹持件64与第一锁紧管61可以不是一体成型，比如固定连接或者可拆卸连接；挤压件63与第二锁紧管62可以不是一体成型，比如固定连接或者可以可拆卸连接。
当然，在一些实施方式中，当夹持件64设置在第一锁紧管61时，挤压件63还可以设置在外鞘手柄1上。举例来说，夹持件64设置在第一锁紧管61的远端，挤压件63凸设在外鞘手柄1的空腔的内壁面。当第二锁紧管62旋转时，能够带动第一锁紧管61相对于第二锁紧管62沿第一锁紧管61的轴向并向远端移动，使得夹持件64逐渐靠近挤压件63，直至夹持件64和挤压件63接触时，夹持件64至少在径向上受挤压件63挤压产生形变而夹持内鞘管组件5。
此外，在一些实施方式中，夹持件64可以设置在第二锁紧管62，挤压件63设置在第一锁紧管61。第一锁紧管61套设于第二锁紧管62的外周。当第二锁紧管62旋转时，能够带动第一锁紧管61沿轴向移动，最终实现夹持件64至少在径向上受挤压件63挤压产生形变而夹持内鞘管组件5。
可以理解的是，当夹持件64设置在第二锁紧管62时，挤压件63可以设置在第一锁紧管61的远端。
当然，在一些实施方式中，夹持件64以可拆卸地方式连接于第一锁紧管61和第二锁紧管62之间，第一锁紧管61和第二锁紧管62一体成型有挤压件63。第一锁紧管61和第二锁 紧管62相螺接。部分的夹持件64伸入第一锁紧管61内，部分的夹持件64伸入第二锁紧管62内。夹持件64具有贯穿其近端和远端的穿孔，内鞘管组件5穿装于该穿孔。当第一锁紧管61相对于第二锁紧管62沿第一锁紧管61的轴向向近端移动时，夹持件64被第一锁紧管61和第二锁紧管62上的挤压件63共同挤压，使得夹持件64至少在径向上受挤压件63挤压产生形变而夹持内鞘管组件5。
可以理解的是，夹持件64可以采用弹性材料制成。进一步地，夹持件64为在径向上被挤压时沿径向弹性弯曲变形的弹性件，该弹性件例如由橡胶制成，但不以此为限。夹持件64还可以由铜材料制成，这样可提高夹持件64的耐磨性。
需要说明的是，夹持件64可以一体设置于第一锁紧管61上，夹持件64可以一体设置于第二锁紧管62上。例如，夹持件64一体设置于第一锁紧管61的近端，夹持件64一体设置于第二锁紧管62的远端。
挤压件63可以一体设置于第一锁紧管61上，挤压件63可以一体设置于第二锁紧管62上，挤压件63还可以一体设置于外鞘手柄1。
当然，夹持件64还可以可拆卸地连接于第一锁紧管61或第二锁紧管62。挤压件63也可以可拆卸地连接于第一锁紧管61、第二锁紧管62或外鞘手柄1。
第一锁紧管61和第二锁紧管62可以螺纹连接。第一锁紧管61具有外螺纹，第二锁紧管62具有内螺纹，第二锁紧管62套设于第一锁紧管61的外周，且螺纹连接。在一些实施方式中，第一锁紧管61具有内螺纹，第二锁紧管62具有外螺纹，第一锁紧管61套设于第二锁紧管62的外周，且螺纹连接。在一些实施方式中，第一锁紧管61和第二锁紧管62通过倾斜设置的导槽与导轨实现滑动连接。
请继续参阅图6至图8，第二锁紧管62包括第一管段621，第一锁紧管61穿设于第一管段621。第一管段621的内壁面可以具有内螺纹，第一锁紧管61的外周具有外螺纹，第一锁紧管61穿设于第一管段621，并与第一管段621螺纹连接。
挤压件63设置在第一管段621的近端，且倾斜向第二锁紧管62的轴线方向延伸，即挤压件63的近端向第二锁紧管62内部空间延伸，或者说挤压件63是倾斜的，挤压件63的近侧部分相对于其远侧部分距离第二锁紧管62的轴线更近。由于挤压件63倾斜向第二锁紧管62的轴线方向延伸，故当第一锁紧管61沿其轴向向近端移动时，夹持件64受到挤压件63的挤压而至少在径向上产生形变，进而夹持内鞘管组件5。
挤压件63的内壁面具有第一滑动面631，第一滑动面631的近端的径向尺寸相较于其远端的径向尺寸较小，即第一滑动面631中近侧部分是收拢的，用于与夹持件64的近端滑动配合，且至少在径向上挤压夹持件64。
在本实施例中，第一滑动面631的径向尺寸由远端至近端逐渐减小，使得夹持件64能够与第一滑动面631实现较好的滑动配合，在夹持件64和挤压件63滑动配合的过程中，夹持件64至少在径向上产生形变。第一滑动面631的径向尺寸逐渐缩小的设计，更有利于夹持件64在径向上产生形变。在一些实施方式中，第一滑动面631为锥面或弧面。
夹持件64的近端具有第二滑动面641，第二滑动面641用于与第一滑动面631滑动配合，使得至少在径向上第一滑动面631能够挤压第二滑动面641，以使夹持件64产生形变而夹持内鞘管组件5。
可以理解的是，第一滑动面631和第二滑动面641可以为平面或曲面。举例来说，第一滑动面631和第二滑动面641可以均为平面，也可以均为曲面，还可以是一个为平面，另一个为曲面。
在本实施例中，第一滑动面631和第二滑动面641均为锥面。
在一些实施方式中，在锁紧状态下，第一滑动面631和第二滑动面641相互脱离，且第二滑动面641移动至第一滑动面631的近端或近侧。在一些实施方式中，在锁紧状态下，第一滑动面631和第二滑动面641相互抵接。
第二锁紧管62还包括第二管段622，第二管段622连接在挤压件63的近端。也就是说，由远端至近端，第二锁紧管62依次包括第一管段621、挤压件63和第二管段622。锁紧构件6还包括旋钮65，旋钮65固定连接于第二锁紧管62，并显露于外鞘手柄1。旋钮65外露于外鞘手柄1，用于接收操作者的周向旋转操作。
请继续参阅图7与图8，第一锁紧管61的近端设有夹持件64，第一锁紧管61的远端设有限位部611，限位部611呈筒状，便于内鞘管组件5从中穿设。限位部611在垂直于轴向的横截面上呈方框状，包括相对设置的顶壁与底壁，以及连接在顶壁与底壁之间的两个相对设置的侧壁。该两侧壁用于与外鞘手柄1限位配合，使得第一锁紧管61仅能够沿其轴向移动，而不能沿周向旋转。在其他实施方式中，该顶壁与底壁用于与外鞘手柄1限位配合，使得第一锁紧管61仅能够沿其轴向移动，而不能沿周向旋转。
夹持件64设置于第一锁紧管61的近端，其包括多个沿周向间隔设置的夹爪642，沿周向方向，相邻的两个夹爪642之间具有间隙。在挤压件63的挤压作用下，多个夹爪642的近端产生形变相互靠拢，而夹持内鞘管组件5。每个夹爪642的近端外侧设置有上述第二滑动面641。
如图4和图9所示，图9示出的是本申请实施例的外鞘构件100的局部剖视图。外鞘手柄1包括外手柄壳体11和第一注液接头12，外手柄壳体11围成外鞘手柄1的空腔，第一注液接头12设置在外鞘手柄1的空腔内，且与外鞘管组件2的近端连通。外手柄壳体11包括外鞘接口部111，外鞘接口部111形成有第一开口112，外鞘手柄1中的空腔延伸至外鞘接口部111，并贯通至第一开口112，第一注液接头12是设置于外鞘接口部111中，通过第一开口112显露于外手柄壳体11表面，用于与第一注射装置(图中未示出)连接，第一注射装置通过第一注液接头12向外鞘管组件2提供液体。可以理解的是，第一注射装置提供的液体包括但不限于生理盐水、显影剂或者是其他的一些药物等。
外鞘手柄1还包括第一导电接头13，第一导电接头13设置在外鞘手柄1的空腔内，具体是设置于外鞘接口部111中，且与外鞘管组件2电连接，第一导电接头13穿出外鞘接口部111设有第一开口112的端面而显露于外鞘手柄1表面，用于与第一外部电源(图中未示出)连接，第一外部电源通过第一导电接头13向外鞘管组件2提供电能。可以理解的是，第一外部电源提供的电能能够传递至可植入装置8的第一连接件83。
外鞘接口部111凸设于外手柄壳体11的外壁，第一开口112设置于外鞘接口部111远离外手柄壳体11的一端，外鞘接口部111的凸伸方向相对于外手柄壳体11的轴线倾斜，第一开口112朝向外手柄壳体11的近端。
外鞘接口部111凸设于外手柄壳体11的外壁，可缓解外鞘手柄1的空腔体积不足的问题。此外，外鞘接口部111相对于外手柄壳体11的轴线倾斜设置，且外鞘接口部111的用于设置第一开口112及第一导电接头13的端面朝向外手柄壳体11的近端，这样方便操作者插接第一注射装置以及第一外部电源。
如图10至图12所示，图10示出的是本申请实施例的第一注液接头12的示意图。图11示出的是本申请实施例的第一注液接头12的分解示意图。图12示出的是本申请实施例的第一注液接头12的剖视图。本申请实施例的第一注液接头12包括阀体14和启闭组件15，阀 体14形成接收通道141和流体通道142，接收通道141与第一开口112连通，用于接收第一注射装置的注射端，流体通道142与外鞘管组件2连通。启闭组件15形成有切口151，切口151贯穿启闭组件15的厚度方向的两个相对的侧面，启闭组件15设于接收通道141与流体通道142之间，第一注射装置的注射端用于沿着接收通道141穿过切口151进入流体通道142，并向流体通道142注射液体，液体流经流体通道142进入外鞘管组件2的内腔。
可以理解的是，本申请实施例的第一注液接头12设置在外鞘手柄1的空腔内，第一注液接头12的接收通道141能够接收第一注射装置的注射端，注射端能够沿着接收通道141穿过切口151进入流体通道142，从而使第一注射装置的液体沿着接收通道141穿过切口151进入流体通道142，最终进入外鞘管组件2的内腔。相比于相关技术中采用外接的三通阀向外鞘管组件2供给液体的方式，本实施例的第一注液接头12集成在外鞘手柄1中，一方面提高了外鞘手柄1的集成度，另一方面也方便外鞘构件100的周向旋转以及轴向运动。
启闭组件15包括弹性的垫片15a，垫片15a形成有切口151。在一实施方式中，切口151可以为“十”字型。当第一注射装置的注射端插入切口151时，切口151被撑开，注射端流出的液体能够经过流体通道142从第一注液接头12流出。切口151在自然状态下呈关闭状态，接收通道141与流体通道142被垫片15a隔离。
当切口151被撑开时，第一注液接头12能够接收第一注射装置的液体。当切口151关闭时，接收通道141与流体通道142被垫片15a隔离，确保外鞘构件100内腔的密封性，避免外界空气从第一注液接头12进入到外鞘管组件2内腔。
阀体14包括第一座体143和第二座体144，第一座体143与第二座体144可拆卸连接。第一座体143形成有接收通道141，第二座体144包括相互连接的通道部145和连接部146，连接部146与第一座体143可拆卸地连接，通道部145与连接部146形成有流体通道142。启闭组件15夹设在第一座体143和第二座体144之间。
在一实施方式中，连接部146与第一座体143可以通过螺纹连接，例如连接部146的外周具有外螺纹，第一座体143的内壁具有外螺纹。当然，还可以是连接部146套设于第一座体143的外周。
通过连接部146与第一座体143的螺纹连接的设计，可方便拆装第一座体143和第二座体144，从而方便组装以及更换垫片15a。在其他实施方式中，连接部146与第一座体143不限于通过螺纹连接，比如通过卡接，粘接等至少一种方式进行连接。
连接部146正对接收通道141的位置形成向远离接收通道141方向凹陷的容纳槽147，启闭组件15覆盖容纳槽147的开口，容纳槽147用于容纳第一注射装置的注射端，容纳槽147的底面形成用于抵接注射端的抵接面1471。接收通道141为等径通道，流体通道142为等径通道，等径通道为，通道的不同轴向位置处，径向尺寸相同，第一注射装置的注射端可以经由接收通道141以及流体通道142抵触抵接面1471。接收通道141与流体通道142的径向尺寸可以相同或不同。
第一注射装置的注射端插入第一注液接头12后，注射端穿过切口151后能够与容纳槽147的抵接面1471相抵接，当注射端与抵接面1471抵接后，操作者则知晓注射端已插接到位，提高了操作者的操作手感。
如图12和图13所示，图13示出的是本申请实施例的第二座体144的示意图。抵接面1471形成有向远离启闭组件15方向凹陷的导流槽148，且导流槽148与流体通道142连通。当第一注射装置的注射端与容纳槽147的抵接面1471抵接后，液体可通过导流槽148流入流体通道142。导流槽148的设计有利于液体流通，避免抵接面1471阻碍液体流入流体通道142。
在一实施方式中，导流槽148的形状可以为“十”形，但不以此为限。
如图6、图9和图14所示，其中图14示出的是本申请实施例的连接管17的两端分别连接外鞘接头16和第一注液接头12的示意图。外鞘手柄1还包括外鞘接头16和连接管17。外鞘接头16设置在外手柄壳体11的空腔中，且整体大致呈管状。外鞘接头16具有相互连通的主通道161和支通道162，外鞘管组件2的近端连接于外鞘接头16的远端，并与主通道161连通，内鞘管组件5穿设于主通道161中，并从主通道161的两端穿出。连接管17的一端与流体通道142连通，另一端与支通道162连通。
外鞘接头16包括端头167、中间件168和底座169。由远端至近端，端头167、中间件168和底座169依次可拆卸连接，如端头167与中间件168的一端螺纹连接，中间件168的另一端与底座169螺纹连接。
外鞘软管21的近端固定连接在外鞘接头16中。作为一示例，外鞘软管21的近端固定在端头167和中间件168之间，具体来说，外鞘软管21、端头167和中间件168的组装过程中，外鞘软管21的近端穿装在端头167的近端的穿孔内，并对外鞘软管21的近端进行扩口，使外鞘软管21的近端变形为锥筒状，并与端头167的近端穿孔的孔壁形状相适配，之后再将中间件168与端头167组装，使得呈锥筒状的外鞘软管21的近端被夹紧在端头167的穿孔的孔壁和中间件168的远端之间。
外鞘接头16还包括具有弹性的密封件165，密封件165设置在外鞘接头16的近端，例如夹设在中间件168的近端和底座169之间。密封件165的轴向上设置有供内鞘管组件5穿过的开孔166，例如开孔166可供加强管54和内鞘软管51穿过。
作为一示例，外鞘接头16用于连通第一注液接头12和外鞘管组件2，还通过设置密封件165以密封外鞘接头16的近端。
在本实施例中，端头167与中间件168设计为可拆卸的分体结构，便于外鞘软管21的近端的组装。中间件168与底座169设计为可拆卸的分体结构，便于密封件165的组装。
外鞘接头16包括主管道163和支管道164。主管道163形成主通道161，主管道163的远端连接外鞘软管21的近端，且主通道161连通外鞘软管21的内腔，以用于穿设内鞘管组件5。支管道164形成支通道162，且支通道162连通主通道161。其中，请结合图9、图14及图16，第一注液接头12的通道部145位于主管道163的轴线的一侧，支管道164旁接于主管道163的邻近通道部145的通道口的一侧管壁。可选地，支管道164的轴线与主管道163的轴线可以相互倾斜，也可以相互垂直。如图9及图14所示，作为一示例，支管道164和主管道163呈Y字型结构，支管道164的轴线与主管道163的轴线倾斜设置，且支管道164远离主管道163的一端向主管道163的近端延伸。连接管17的相对两端分别连通于通道部145的通道口以及支管道164的远离主管道163的一端管口。通过支管道164的轴线与主管道163的轴线倾斜设置，且支管道164向主管道163的近端延伸的设计，使得连接管17的两端分别连接支管道164和第一注液接头12的通道部145后，有利于增大连接管17两端之间的距离，减小连接管17的曲率与长度。
第一注射装置提供的液体依次流经第一注液接头12、连接管17、支管道164、主管道163、外鞘管组件2的近端，直至外鞘管组件2的远端。
在本实施例中，外鞘接头16的主管道163可以由端头167、中间件168和底座169共同形成，支管道164可以形成在中间件168。
请继续参阅图10、图12和图14，流体通道142的轴线和接收通道141的轴线相互错开，以使通道部145的外壁相对于连接部146的外壁形成一向流体通道142轴线方向凹陷的避让 空间149。外鞘接头16及/或外鞘管组件2穿过避让空间149，避免通道部145与外鞘接头16及/或外鞘管组件2相干涉。
在本实施例中，通过流体通道142的轴线和接收通道141的轴线相互错开的设计，一方面，使得通道部145和连接部146的外壁共同形成一空间较大的避让空间149，该避让空间149用于供外鞘接头16及/或外鞘管组件2穿过，这样可进一步提高外鞘手柄1的集成度，有效利用外手柄壳体11内的体积，减小了外鞘手柄1的尺寸；另一方面，第一注液接头12的通道部145远离外鞘接头16的支管道164的出口(即支管道164的远离主管道163的一端的管口)，进而可调节连接管17的弯曲曲率与长度。
如图14所示，外鞘手柄1还包括定位结构18，定位结构18设置在外鞘手柄1的空腔的内壁，且位于外鞘手柄1的近端，用以将连接管17定位于外鞘手柄1的近端侧。
在一实施方式中，定位结构18可以包括定位柱181和定位框182。定位框182相较于定位柱181靠近近端。连接管17的一个区段(在图中为其中间部分)被定位在定位柱181和定位框182之间。
需要说明的是，定位框182从外手柄壳体11的内壁向外手柄壳体11的内部延伸，还形成一定位腔183，该定位腔183呈方框状，用于限制第一锁紧管61的限位部611(具体为其两侧壁)的周向移动。具体来说，第一锁紧管61的限位部611设置在定位腔183内，限位部611仅能够相对于定位框182沿着轴向移动，而不能周向旋转。
如图5和图15所示，图15示出的是本申请实施例的内鞘构件200的局部剖视图。内鞘手柄4包括内手柄壳体41和第二注液接头42，第二注液接头42设置在内手柄壳体41内，且与内鞘管组件5的近端连通。内手柄壳体41包括内鞘接口部411，内鞘接口部411形成有第二开口412，第二开口412用于实现第二注液接头42与第二注射装置(图中未示出)之间的连接，第二注射装置用于向内鞘管组件5提供液体。第二注射装置提供的液体包括但不限于生理盐水、显影剂或者是其他的一些药物等。可选地，在一实施方式中，第二注射装置可以通过三通阀44连接第二注液接头42，三通阀44的其中一阀口连接有管道，该管道远离三通阀44的一端通过第二开口412穿入内手柄壳体41内，从而与第二注液接头42进行连接(具体为连接于第二注液接头42的第二通道422，后文有详细描述)。
内鞘手柄4还包括呈管状的导丝口45，导丝口45与内鞘管组件5的内腔连通。导丝口45的一端显露于内鞘手柄4的表面，通过该导丝口45，可供导丝穿过导丝口45而进入内鞘管组件5的内腔。
第二注液接头42包括相连通的第一通道421和第二通道422。第一通道421的近端连通导丝口45，第一通道421的远端连通内鞘管组件5的内腔。第二通道422的近端用于与第二注射装置连通，第二通道422的远端连通第一通道421。第一通道421轴线和第二通道422的轴线倾斜设置，且第二通道422的近端向第一通道421的近端延伸。
内鞘手柄4还包括第二导电接头43，第二导电接头43设置在内手柄壳体41内，且与内鞘管组件5电连接，第二导电接头43穿出内鞘接口部411设有第二开口412的端面而显露于内鞘手柄4表面，用于与第二外部电源(图中未示出)连接，第二外部电源通过第二导电接头43向内鞘管组件5提供电能。
请继续参阅图5、图6和图15，内鞘管组件5包括内鞘软管51、加强管54和导套53。内鞘软管51穿装于外鞘构件100，具体来说，内鞘软管51穿装于外鞘管组件2、外鞘接头16和锁紧构件6。内鞘软管51的远端伸出外鞘管组件2的远端，并与可植入装置8的第二连接件84连接，内鞘软管51的近端伸出外鞘手柄1的近端，并与内鞘手柄4连接。同时，内 鞘软管51的近端伸入内手柄壳体41内，并与第二注液接头42连接。加强管54套设于内鞘软管51的外周，用于穿装于外鞘构件100的外鞘接头16中。在外鞘手柄1与内鞘手柄4之间的间距满足一定范围内的情况下(比如在外鞘手柄1和内鞘手柄4轴向间距最小的情况下，两者间距在0-5cm范围内的情况下，或其他输送与释放封堵装置过程中两手柄之间的其他间距范围)，加强管54的远端伸出外鞘手柄1，加强管54的近端与导套53连接。导套53穿装于外鞘构件100的锁紧构件6，具体来说，导套53穿装于锁紧构件6的第一锁紧管61和第二锁紧管62。当锁紧构件6处于锁紧状态时，夹持件64用于夹持导套53的外周。并且在外鞘手柄1与内鞘手柄4之间的间距满足一定范围内的情况下(比如在外鞘手柄1和内鞘手柄4轴向间距最小的情况下，两者间距在0-5cm范围内的情况下，或其他输送与释放封堵装置过程中两手柄之间的其他间距范围)，导套53的远端延伸至外鞘手柄1的内腔，且套设在加强管54的近端外周，导套53的近端伸出外鞘手柄1的近端，且与内手柄壳体41连接。
其中，导套53的硬度大于内鞘软管51的硬度。由于夹持件64夹持硬度较大的导套53，而未夹持硬度较小的内鞘软管51，使得导套53能够保护内鞘软管51，防止内鞘软管51被夹变形，而影响内部液体的流动。
此外，加强管54的硬度大于内鞘软管51的硬度，导套53的远端套设在加强管54的近端外周，这样便于内鞘手柄4一侧的力矩传递至相对硬度较差的内鞘软管51。
加强管54和内鞘软管51均穿设于外鞘接头16的密封件165的开孔166，由于加强管54套设在内鞘软管51的外周，故加强管54的外壁与密封件165直接接触。加强管54的硬度相较于内鞘软管51较高，使得内鞘管组件5穿置外鞘接头16的位置的材料硬度得到加强，加强管54起到保护内鞘软管51的作用，避免密封件165压迫内鞘软管51，破坏内鞘软管51的结构，影响内鞘软管51的轴向移动和周向旋转，以及其内部的液体传输。
可以理解的是，本申请提供的各个实施例/实施方式在不产生矛盾的情况下可以相互组合，此处不再一一举例说明。
在发明实施例中，术语“第一”、“第二”、“第三”仅用于描述的目的，而不能理解为指示或暗示相对重要性；术语“多个”则指两个或两个以上，除非另有明确的限定。术语“安装”、“相连”、“连接”、“固定”等术语均应做广义理解，例如，“连接”可以是固定连接，也可以是可拆卸连接，或一体地连接；“相连”可以是直接相连，也可以通过中间媒介间接相连。对于本领域的普通技术人员而言，可以根据具体情况理解上述术语在发明实施例中的具体含义。
发明实施例的描述中，需要理解的是，术语“上”、“下”、“左”、“右”、“前”、“后”等指示的方位或位置关系为基于附图所示的方位或位置关系，仅是为了便于描述发明实施例和简化描述，而不是指示或暗示所指的装置或单元必须具有特定的方向、以特定的方位构造和操作，因此，不能理解为对发明实施例的限制。
在本说明书的描述中，术语“一个实施例”、“一些实施例”、“具体实施例”等的描述意指结合该实施例或示例描述的具体特征、结构、材料或特点包含于发明实施例的至少一个实施例或示例中。在本说明书中，对上述术语的示意性表述不一定指的是相同的实施例或实例。而且，描述的具体特征、结构、材料或特点可以在任何的一个或多个实施例或示例中以合适的方式结合。
以上仅为发明实施例的优选实施例而已，并不用于限制发明实施例，对于本领域的技术人员来说，发明实施例可以有各种更改和变化。凡在发明实施例的精神和原则之内，所作的任何修改、等同替换、改进等，均应包含在发明实施例的保护范围之内。

Claims (29)

  1. 一种输送装置，其特征在于，包括：
    外鞘构件，包括外鞘手柄和至少部分设置于所述外鞘手柄远侧的外鞘管组件，所述外鞘手柄和所述外鞘管组件均在各自的近端与远端之间形成空腔，两个所述空腔相连通；所述外鞘手柄用于供操作者操作，以带动所述外鞘管组件运动，所述外鞘管组件的远端用于与可植入装置可拆卸连接；
    内鞘构件，包括内鞘手柄以及至少部分设置于所述内鞘手柄远侧的内鞘管组件，所述内鞘管组件用于穿设于两所述空腔，且所述内鞘管组件的远端用于与所述可植入装置可拆卸连接，至少部分所述内鞘手柄外露于所述外鞘手柄，所述内鞘手柄用于供操作者操作，以带动所述内鞘管组件运动。
  2. 根据权利要求1所述的输送装置，其特征在于，所述内鞘手柄和所述外鞘手柄在轴向上间隔设置。
  3. 根据权利要求1所述的输送装置，其特征在于，所述内鞘手柄设置在所述输送装置的近端，所述内鞘管组件能够在所述内鞘手柄的带动下，从所述外鞘构件的两所述空腔中向近侧移动直至与所述外鞘构件完全脱离。
  4. 根据权利要求1所述的输送装置，其特征在于，
    所述外鞘手柄能够带动所述外鞘管组件相对于所述内鞘构件在轴向上移动，或者在周向上旋转；及/或
    所述内鞘手柄能够带动所述内鞘管组件相对于所述外鞘构件在轴向上移动，或者在周向上旋转。
  5. 根据权利要求1至4任一项所述的输送装置，其特征在于，所述输送装置还包括锁紧构件，所述锁紧构件连接在所述外鞘手柄与所述内鞘管组件之间，所述锁紧构件能够在锁紧状态和解锁状态之间相互转换；
    在解锁状态下，所述外鞘构件和所述内鞘构件能够产生相对运动；
    在锁紧状态下，所述锁紧构件产生形变并夹紧所述内鞘管组件，从而阻止所述内鞘构件与所述外鞘构件产生相对运动。
  6. 根据权利要求5所述的输送装置，其特征在于，部分所述锁紧构件设置于所述外鞘手柄的空腔中，所述内鞘管组件穿设于所述锁紧构件。
  7. 根据权利要求6所述的输送装置，其特征在于，所述锁紧构件包括：
    第一锁紧管，沿轴向可移动地设置在所述外鞘手柄的空腔内，所述内鞘管组件穿设于所述第一锁紧管内；
    第二锁紧管，沿轴向固定且沿周向可旋转地连接于所述外鞘手柄，所述第二锁紧管用于带动所述第一锁紧管相对于所述第二锁紧管沿所述第一锁紧管的轴向产生相对移动；
    挤压件，设置在所述第一锁紧管、所述第二锁紧管或所述外鞘手柄上；以及
    夹持件，设置在所述第一锁紧管和/或所述第二锁紧管上，在所述第二锁紧管旋转带动所述第一锁紧管相对于所述第二锁紧管沿所述第一锁紧管的轴向产生相对移动的过程中，所述夹持件至少在径向上受所述挤压件挤压产生形变而夹持所述内鞘管组件。
  8. 根据权利要求7所述的输送装置，其特征在于，所述第一锁紧管和所述第二锁紧管螺纹连接。
  9. 根据权利要求7所述的输送装置，其特征在于，所述第二锁紧管套设于所述第一锁紧 管的外围，所述夹持件设置在所述第一锁紧管的近端；所述挤压件设置于所述第二锁紧管的内壁表面。
  10. 根据权利要求9所述的输送装置，其特征在于，所述第二锁紧管包括第一管段，所述第一锁紧管穿设于所述第一管段；
    所述挤压件设置在所述第一管段的近端，且倾斜向所述第二锁紧管的轴线方向延伸。
  11. 根据权利要求10所述的输送装置，其特征在于，所述挤压件的内壁面具有第一滑动面，所述第一滑动面的远端相对于近端的径向尺寸较小，所述第一滑动面用于与所述夹持件的近端滑动配合，且至少在径向上挤压所述夹持件。
  12. 根据权利要求11所述的输送装置，其特征在于，所述夹持件包括多个沿周向间隔设置的夹爪，所述夹爪的近端设置有第二滑动面，所述第二滑动面用于与所述第一滑动面滑动配合，使得至少在径向上所述第一滑动面能够挤压所述第二滑动面，以使多个所述夹爪至少在其近端产生形变相互靠拢，从而夹持所述内鞘管组件。
  13. 根据权利要求10所述的输送装置，其特征在于，所述第二锁紧管还包括第二管段，所述第二管段设置在所述挤压件的近端；所述锁紧构件还包括旋钮，所述旋钮固定连接于所述第二锁紧管，并显露于所述外鞘手柄表面。
  14. 根据权利要求6所述的输送装置，其特征在于，所述内鞘管组件包括导套与内鞘软管，所述导套的近端与所述内鞘手柄连接，所述导套套设于所述内鞘软管的外围，所述导套的硬度大于所述内鞘软管的硬度，所述锁紧构件用于夹紧所述导套的外周。
  15. 根据权利要求1所述的输送装置，其特征在于，所述外鞘手柄包括外手柄壳体和第一注液接头，所述外手柄壳体围成所述外鞘手柄的空腔，所述外手柄壳体包括外鞘接口部，所述外鞘接口部形成有第一开口，所述外鞘手柄中的空腔延伸至所述外鞘接口部，并贯通至所述第一开口，所述第一注液接头设置于所述外鞘接口部，通过所述第一开口显露于所述外手柄壳体表面，用于与第一注射装置连接，所述第一注射装置用于通过所述第一注液接头向所述外鞘管组件提供液体；
    所述内鞘手柄包括内手柄壳体和第二注液接头，所述第二注液接头设置在所述内手柄壳体内，且与所述内鞘管组件的近端连通；所述内手柄壳体包括内鞘接口部，所述内鞘接口部形成有第二开口，所述第二注液接头设置于所述内鞘接口部，通过所述第二开口显露于所述内手柄壳体表面，用于与第二注射装置连接，所述第二注射装置用于向所述内鞘管组件提供液体。
  16. 根据权利要求15所述的输送装置，其特征在于，所述外鞘手柄还包括第一导电接头，所述第一导电接头设置在所述外鞘接口部，且与所述外鞘管组件电连接，所述第一导电接头通过所述第一开口显露于所述外鞘手柄，用于与第一外部电源连接，所述第一外部电源通过所述第一导电接头向所述外鞘管组件提供电能；和/或，
    所述内鞘手柄还包括第二导电接头，所述第二导电接头设置在所述内鞘接口部，且与所述内鞘管组件电连接，所述第二导电接头通过所述第二开口显露于所述内鞘手柄，用于与第二外部电源连接，所述第二外部电源通过所述第二导电接头向所述内鞘管组件提供电能。
  17. 根据权利要求15所述的输送装置，其特征在于，所述外鞘接口部凸设于所述外手柄壳体的外壁，所述第一开口设置于所述外鞘接口部远离所述外手柄壳体的一端，所述外鞘接口部的凸伸方向相对于所述外手柄壳体的轴线倾斜，所述第一开口朝向所述外手柄壳体的近端。
  18. 根据权利要求15至17任一项所述的输送装置，其特征在于，
    所述第一注液接头包括阀体和启闭组件，所述阀体形成接收通道和流体通道，所述接收通道与所述第一开口连通，用于接收所述第一注射装置的注射端，所述流体通道与所述外鞘管组件连通；所述启闭组件形成有切口，所述切口贯穿所述启闭组件的厚度方向的两个相对的侧面，所述启闭组件设于所述接收通道与流体通道之间，所述第一注射装置的注射端用于沿着所述接收通道穿过所述切口进入所述流体通道，并向所述流体通道注射液体，所述液体流经所述流体通道进入所述外鞘管组件的内腔。
  19. 根据权利要求18所述的输送装置，其特征在于，所述启闭组件包括具有弹性的垫片，所述垫片形成有所述切口；
    当所述第一注射装置的注射端插入所述切口时，所述切口撑开，所述注射端流出的液体能够经过所述流体通道从所述第一注液接头流出；
    所述切口在自然状态下呈关闭状态，所述接收通道与所述流体通道被所述垫片隔离。
  20. 根据权利要求18所述的输送装置，其特征在于，所述阀体包括：
    第一座体，所述第一座体形成有所述接收通道；以及
    第二座体，包括相互连接的通道部和连接部，所述连接部与所述第一座体可拆卸地连接；所述通道部与所述连接部形成有所述流体通道；
    其中，所述启闭组件夹设在所述第一座体和所述第二座体之间。
  21. 根据权利要求20所述的输送装置，其特征在于，所述连接部正对所述接收通道的位置形成向远离所述接收通道方向凹陷的容纳槽，所述启闭组件覆盖于所述容纳槽的开口，所述容纳槽用于容纳所述第一注射装置的注射端，所述容纳槽的底面形成用于抵接所述注射端的抵接面。
  22. 根据权利要求21所述的输送装置，其特征在于，所述抵接面形成有向远离所述启闭组件方向凹陷的导流槽，且所述导流槽与所述流体通道连通。
  23. 根据权利要求20所述的输送装置，其特征在于，所述通道部的外壁相对于所述连接部的外壁形成一向所述流体通道轴线方向凹陷的避让空间；所述外鞘构件包括外鞘接头，所述外鞘接头用于连接所述第一注液接头的流体通道和所述外鞘管组件；所述外鞘接头及/或所述外鞘管组件穿过所述避让空间。
  24. 根据权利要求23所述的输送装置，其特征在于，所述流体通道的轴线和所述接收通道的轴线相互错开。
  25. 根据权利要求18所述的输送装置，其特征在于，所述外鞘手柄还包括：
    外鞘接头，设置在所述外手柄壳体的空腔中，且具有相互连通的主通道和支通道，所述外鞘管组件的近端连接于所述外鞘接头的远端，并与所述主通道连通，所述内鞘管组件穿设于所述主通道的两端；
    连接管，所述连接管的一端与所述流体通道连通，另一端与所述支通道连通。
  26. 根据权利要求25所述的输送装置，其特征在于，所述外鞘接头包括：
    主管道，形成所述主通道；所述主管道的远端连接所述外鞘管组件的近端，所述内鞘管组件穿设于所述主管道；以及
    支管道，形成所述支通道，且连接于所述主管道；所述支管道的轴线相对于所述主管道的轴线倾斜设置，且所述支管道远离所述主管道的一端向所述主管道的近端延伸。
  27. 根据权利要求25所述的输送装置，其特征在于，所述内鞘管组件包括：
    内鞘软管，所述内鞘软管的远端与所述可植入装置连接；
    加强管，套设于所述内鞘软管的外周；所述加强管的硬度大于所述内鞘软管的硬度；
    其中，所述外鞘接头呈管状，所述外鞘接头的近端设置有弹性的密封件，所述密封件的轴向上设置有供所述加强管以及所述内鞘软管穿过的开孔。
  28. 根据权利要求25所述的输送装置，其特征在于，所述外鞘手柄还包括用于对所述连接管进行定位的定位结构，所述定位结构设置在所述外鞘手柄的空腔的内壁，且位于所述外鞘手柄的近端。
  29. 一种医疗器械系统，其特征在于，包括：
    可植入装置，包括相互间隔设置的第一连接件与第二连接件；以及
    如权利要求1至28任一项所述的输送装置，所述外鞘管组件的远端用于与所述第一连接件可拆卸连接，所述内鞘管组件的远端用于与所述第二连接件可拆卸连接；所述输送装置用于将所述可植入装置输送并释放至患者体内。
PCT/CN2023/090694 2022-04-28 2023-04-25 输送装置及医疗器械系统 WO2023208002A1 (zh)

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