WO2023124212A1 - 医用辅件、医用介入系统及其排气方法 - Google Patents

医用辅件、医用介入系统及其排气方法 Download PDF

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Publication number
WO2023124212A1
WO2023124212A1 PCT/CN2022/117616 CN2022117616W WO2023124212A1 WO 2023124212 A1 WO2023124212 A1 WO 2023124212A1 CN 2022117616 W CN2022117616 W CN 2022117616W WO 2023124212 A1 WO2023124212 A1 WO 2023124212A1
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WO
WIPO (PCT)
Prior art keywords
valve
medical
sheath
distal end
cylinder
Prior art date
Application number
PCT/CN2022/117616
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English (en)
French (fr)
Inventor
江巍
罗瑞聪
王泽涛
Original Assignee
杭州德晋医疗科技有限公司
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 CN202210199989.8A external-priority patent/CN116407361A/zh
Application filed by 杭州德晋医疗科技有限公司 filed Critical 杭州德晋医疗科技有限公司
Publication of WO2023124212A1 publication Critical patent/WO2023124212A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts

Definitions

  • the present application relates to the technical field of medical devices, in particular to a medical accessory, a medical intervention system and an exhaust method thereof.
  • Atrioventricular valves such as the mitral valve and tricuspid valve are one-way valves in the heart.
  • a normal and healthy atrioventricular valve can control the flow of blood from the atrium to the ventricle while preventing blood from flowing from the ventricle to the atrium.
  • the mitral valve is a one-way valve located between the left atrium and left ventricle of the heart, which controls blood flow from the left atrium to the left ventricle while preventing blood flow from the left ventricle to the left atrium;
  • the tricuspid valve is located in the right atrium of the heart
  • the one-way valve between the right ventricle and the right ventricle can control the flow of blood from the right atrium to the right ventricle, while preventing the flow of blood from the right ventricle to the right atrium.
  • the mitral valve includes an anterior leaflet and a posterior leaflet
  • the tricuspid valve includes an anterior leaflet, a posterior leaflet, and a septal leaflet.
  • the implant needs to be implanted at a predetermined position with the help of the medical intervention system where it is located.
  • the implants need to be protected to prevent damage and failure of the implants; before the medical interventional system is used, the entire system needs to be strictly exhausted to prevent air Substitute into the human body and cause air embolism.
  • it is also necessary to perform a loading operation on the implant.
  • the purpose of the present application is to provide a medical accessory, a medical intervention system and an exhaust method thereof, the medical accessory can be used for protecting and/or loading medical implants and the exhaust of the medical intervention system.
  • the present application provides a medical accessory, including a first element and a second element.
  • the first element includes a first cylinder, a tube sealingly connected to the distal end of the first cylinder, a first cap detachably connected to the proximal end of the first cylinder, and disposed in the first cylinder.
  • the first sealing body and the first on-off valve sealingly connected to the inner cavity of the first cylinder.
  • the first sealing body has a first inner hole, and the first cap can selectively squeeze the first sealing body so that the diameter of the first inner hole is reduced.
  • the second element includes a second cylinder and a second on-off valve sealingly connected to the inner chamber of the second cylinder.
  • the distal end of the first cylinder is detachably connected to the proximal end of the second cylinder.
  • the tube protrudes into the inner cavity of the second cylinder, and the tube A seal is formed with the inner chamber of the second cylindrical body.
  • the present application provides a medical intervention system, including a medical implant, a delivery device, and the above-mentioned medical accessories.
  • the delivery device includes a bending adjustment sheath and a delivery sheath, the delivery sheath is movably installed in the bending adjustment sheath, and the distal end of the delivery sheath is detachably connected to the medical implant, wherein the bending adjustment A first exhaust valve is provided on the sheath, and a second exhaust valve is provided on the delivery sheath.
  • the first element In the first state, the first element is sleeved on the distal end of the bending adjustment sheath, and the distal end of the bending adjustment sheath passes through the first inner hole and is tightly embraced by the first sealing body,
  • the medical implant is accommodated in the inner cavity of the tubular body, and the first element acts alone to protect the medical implant.
  • the first element is sleeved on the distal end of the bending-adjusting sheath and connected to the second element, and the distal end of the bending-adjusting sheath passes through the first inner hole and is held by the
  • the first sealing body is tightly held, and the medical implant is accommodated in the inner cavity of the tubular body; the first element and the second element act in combination to pass through the first on-off valve, the The second on-off valve, the first exhaust valve, and the second exhaust valve exhaust air in the medical interventional system.
  • the present application also provides a method for exhausting the medical interventional system as described above, the exhausting method at least includes the following operations: sleeve the first element on the distal end of the bending adjustment sheath and connect the second element, so that the distal end of the bending adjustment sheath passes through the first inner hole and is tightly embraced by the first sealing body, and the medical implant is accommodated in the tubular body In the inner cavity; keep any two of the second on-off valve, the first exhaust valve and the second exhaust valve closed, and the remaining one is opened together with the first on-off valve, Liquid is injected into the first on-off valve until the liquid flows out of the remaining one.
  • the medical accessory includes a first element and a second element detachably connected to it, and when the first element is used alone, the first The element can be used to protect and/or load a medical implant, and when the first element and the second element are assembled and used together as a whole, the medical accessory can be used to remove the air in the medical interventional system Therefore, the medical interventional system does not need to configure corresponding individual components for the protection and loading of the medical implant and the exhaust of the whole system, so that the overall structure of the medical interventional system is simple and easy to operate, which is beneficial to Reduce operation time.
  • Fig. 1 is a schematic structural diagram of a medical interventional system provided in an embodiment of the present application in a first state.
  • FIG. 2 is an enlarged schematic view of part II in FIG. 1 .
  • Fig. 3 is a sectional view along III-III direction in Fig. 2 .
  • Fig. 4 is a schematic structural diagram of the medical interventional system in Fig. 1 in a second state.
  • FIG. 5 is an enlarged schematic view of a V portion in FIG. 4 .
  • Fig. 6 is an axial sectional view of the second element in Fig. 5 .
  • FIG. 7 is an enlarged schematic view of part VII in FIG. 6 .
  • Fig. 8 is a schematic structural diagram of the medical interventional system in Fig. 1 in a third state.
  • FIG. 9 is a partial axial sectional view of the medical interventional system in FIG. 8 .
  • FIG. 10 is an enlarged schematic view of part X in FIG. 9 .
  • Fig. 11 is a front view of a first component provided by an embodiment of the present application.
  • FIG. 12 is a perspective exploded structural diagram of the first component in FIG. 11 .
  • Fig. 13 is a sectional view along XIII-XIII direction in Fig. 11 .
  • Fig. 14 is a schematic view of the first cap body in Fig. 13 separated from the first cylinder body.
  • FIG. 15 is an enlarged schematic view of part XV in FIG. 13 .
  • Fig. 16 is a partial cross-sectional view of a first barrel, a first cap and a first sealing member provided in another embodiment of the present application.
  • Fig. 17 is a front view of a second component provided by an embodiment of the present application.
  • FIG. 18 is a perspective exploded structural diagram of the second component in FIG. 17 .
  • Fig. 19 is a schematic flowchart of an exhaust method for a medical intervention system provided by an embodiment of the present application.
  • Fig. 20 is a schematic diagram of the exhaust path of the medical accessory.
  • Fig. 21 is a schematic diagram of the exhaust path of the bending sheath.
  • Figure 22 is a schematic diagram of the exhaust path of the delivery sheath.
  • proximal end and distal end in the specification of this application are customary terms in the field of interventional medicine.
  • distal end means the end away from the operator during the operation
  • proximal end means the end close to the operator during the operation.
  • the direction of the central axis of rotation of objects such as cylinders and tubes is defined as the axial direction;
  • circumferential direction is the direction around the axes of objects such as cylinders and tubes (perpendicular to the axis and perpendicular to the section radius);
  • radial is the direction along the diameter or radius.
  • the present application provides a medical intervention system 1 , including a medical implant 20 , a delivery device 40 and a medical accessory 60 .
  • the medical implant 20 may be, but not limited to, a valve clip, a vascular stent, etc.
  • the delivery device 40 is used to deliver the medical implant 20 to the patient
  • the medical accessory 60 is used to protect and/or load the medical implant 20 and Exhaust of medical intervention system 1.
  • the delivery device 40 may include a bending adjustment sheath 41 and a delivery sheath 43 .
  • the delivery sheath 43 is movably installed in the bending adjustment sheath 41 , and the distal end of the delivery sheath 43 is detachably connected to the medical implant 20 .
  • the first exhaust valve 412 and the second exhaust valve 432 are respectively provided on the bending adjustment sheath 41 and the delivery sheath 43, and the first exhaust valve 412 has a communication state with the inner chamber of the bending adjustment sheath 41 and is connected with the adjustment valve.
  • the inner chamber of the curved sheath 41 is isolated from the closed state, and the second exhaust valve 432 has a communication state communicated with the inner chamber of the delivery sheath 43 and a closed state isolated from the inner chamber of the delivery sheath 43 .
  • the bending adjustment sheath 41 includes a bending adjustment sheath tube 414 and a bending adjustment handle 416 connected to the proximal end of the bending adjustment sheath tube 414
  • the delivery sheath 43 includes a delivery sheath tube 434 and a delivery handle connected to the delivery sheath tube 434 proximal end 436.
  • the delivery sheath 434 is inserted into the bending adjustment sheath 414 from the proximal end of the bending handle 416, and the distal end of the delivery sheath 434 can protrude from the distal end of the bending adjustment sheath 414, and is detachably connected to the medical implant 20 .
  • the first exhaust valve 412 and the second exhaust valve 432 are respectively arranged on the bending adjustment handle 416 and the delivery handle 436 .
  • the bending adjustment sheath 41 and the delivery sheath 43 can adopt the bending adjustment sheath and the delivery sheath in the prior art, and the first exhaust valve 412 and the second exhaust valve 432 can both adopt the three-way valve in the prior art, and the bending adjustment sheath 41.
  • the specific structures of the delivery sheath 43, the first exhaust valve 412 and the second exhaust valve 432 will not be repeated here.
  • the medical accessory 60 includes a first element 61 and a second element 62 .
  • the first element 61 includes a first cylinder body 611 , a tube body 613 sealingly connected to the distal end of the first cylinder body 611 , and a detachably connected first cylinder body 611
  • the first cap body 615 at the proximal end, the first sealing body 617 arranged in the first cylinder body 611 and the first on-off valve 612 sealingly connected to the inner cavity of the first cylinder body 611, the first on-off valve 612 has a A connected state in which the lumen of the first element 61 communicates and a closed state in which the lumen of the first element 61 is isolated.
  • the first sealing body 617 has a first inner hole 6172
  • the first cap body 615 can selectively squeeze the first sealing body 617 to reduce the diameter of the first inner hole 6172 .
  • the second element 62 includes a second cylinder body 621 and a second on-off valve 622 that is sealingly connected to the inner cavity of the second cylinder body 621 , and the second on-off valve 622 has The connected state communicates with the lumen of the second element 62 and the closed state isolates the lumen of the second element 62 .
  • the first on-off valve 612 and the second on-off valve 622 can also adopt three-way valves in the prior art, and their specific structures will not be described here. repeat.
  • the distal end of the first cylinder 611 can be detachably connected to the proximal end of the second cylinder 621, so that the first element 61 and the second element 62 are assembled into a As a whole, in a connected state, the tube body 613 protrudes into the inner cavity of the second cylinder body 621 , and a seal is formed between the tube body 613 and the inner cavity of the second cylinder body 621 .
  • the second element 62 further includes a second cap 625 connected to the proximal end of the second cylinder 621 and a second cap disposed on the second cylinder 621 or the second cap.
  • the second sealing body 627 inside the body 625 has a second inner hole 6272 .
  • the distal end of the first barrel 611 is detachably connected to the proximal end of the second cap 625 to realize the connection between the first element 61 and the second element 62 , in the connected state
  • the distal end of the tube body 613 passes through the second inner hole 6272 and is interference-fitted with the second sealing body 627 , so that a seal is formed between the tube body 613 and the inner cavity of the second cylinder body 621 .
  • the first element 61 and the second element 62 are used in different states of the medical interventional system 1 when they are separated from each other and when they are assembled as a whole, so as to realize different functions.
  • the first element 61 is sleeved on the distal end of the bending adjustment sheath 41 (that is, the distal end of the bending adjustment sheath tube 414 ), and the bending adjustment The distal end of the sheath 41 passes through the first inner hole 6172 of the first sealing body 617 and is tightly embraced by the first sealing body 617.
  • the lumen of the tube body 613 is sleeved outside the medical implant 20, and the first element 61 acts alone , so as to protect the medical implant 20 housed in the inner cavity of the tube body 613 .
  • the medical interventional system 1 when the medical interventional system 1 is in the first state, it is mainly used for its packaging, sterilization, transportation and other processes.
  • the diameter of the first inner hole 6172 is equal to or greater than the outer diameter of the distal end of the bend-adjusting sheath 41 (specifically, the outer diameter of the distal end of the bend-adjusting sheath tube 414 ), so that the bend-adjusting sheath 41 The distal end passes through the first inner hole 6172; the inner diameter of the tubular body 613 is equal to or greater than the outer diameter of the distal end of the bending-adjusting sheath 41, so that the bending-adjusting sheath 41 passing through the first inner hole 6172 can further penetrate into the outer diameter of the tubular body 613 lumen.
  • the diameter of the first inner hole 6172 is larger than the outer diameter of the distal end of the bending-adjusting sheath 41 (for example, 2mm-7mm larger), and the inner diameter of the tubular body 613 is also larger than that of the bending-adjusting sheath 41.
  • the outer diameter of the distal end is large (for example, 0.2 mm-1 mm larger), so that the distal end of the bending adjustment sheath 41 can quickly pass through the first inner hole 6172 and penetrate into the lumen of the tubular body 613 . Further preferably, as shown in FIG.
  • the first inner hole 6172 is a tapered hole, the inner diameter of the tapered hole gradually decreases from its proximal end to its distal end, and the tapered hole has a larger penetration opening, It is more convenient for the distal end of the bending sheath 41 to pass through.
  • the first cap body 615 can selectively squeeze the first sealing body 617 so that the diameter of the first inner hole 6172 is reduced, the first sealing body 617 can be tightly passed through the first inner hole 6172 The distal end of the bending adjustment sheath 41, thereby realizing the sealing between the first element 61 and the bending adjustment sheath 41; when the first sealing body 617 is not squeezed by the first cap body 615, the first inner hole 6172 and the tube body There is a gap between 613 and the bend-adjusting sheath 41 , so that the first element 61 can move on the bend-adjusting sheath 41 along the axial direction of the bend-adjusting sheath 41 without resistance.
  • the minimum inner diameter of the lumen of the first cylindrical body 611 is larger than the maximum outer diameter of the medical implant 20 and less than or equal to the inner diameter of the tubular body 613 , so that the gap between the tubular body 613 and the first cylindrical body 611 There will be no steps protruding from the inner wall of the first cylinder 611, which is conducive to the smooth passage of the medical implant 20 into the tube body 613 through the lumen of the first cylinder 611, and the medical implant 20 is placed in the tube body 613. The inside will not be subjected to radial extrusion, preventing damage to the structure of the medical implant 20.
  • the inner diameter of the tubular body 613 is 3mm-8mm
  • the inner diameter of the tubular body 613 is 0.5mm-2mm larger than the maximum outer diameter of the medical implant 20
  • the inner diameter of the tubular body 613 is larger than the maximum outer diameter of the medical implant 20
  • the inner diameter of the tubular body 613 is larger than the maximum outer diameter of the medical implant 20.
  • the minimum inner diameter of a cylinder 611 is 0.2mm-1mm larger.
  • the delivery device 40 further includes an introducer sheath 45
  • the introducer sheath 45 includes an introducer sheath 454 and a guide connected to the proximal end of the guide sheath 454.
  • the handle 456, the introducer sheath 45 is used to establish the intervention channel.
  • the bend-adjusting sheath 414 is movably threaded inside the guide sheath 454 through the guide handle 456 , so that the medical implant 20 is implanted into the patient's body through the intervention channel established by the guide sheath 45 . That is to say, in some embodiments, the medical interventional system 1 also has a third state for delivering the medical implant 20 into the patient's body.
  • the first element 61 is sleeved on the distal end of the bending adjustment sheath 41 , and the distal end of the bending adjustment sheath 41 passes through the first
  • the first inner hole 6172 of the sealing body 617 is tightly embraced by the first sealing body 617
  • the medical implant 20 is accommodated in the inner cavity of the tube body 613
  • the first element 61 works alone, and the tube body 613 is inserted into the guide sheath 45, so that the medical implant 20 is loaded into the guide sheath 45, after that, keep the relative position of the first element 61 and the guide sheath 45, push the bending adjustment sheath 41 and the delivery sheath 43 synchronously, and the delivery device 40 just passes through
  • the intervention channel established by the introducer sheath 45 pushes the medical implant 20 to a predetermined treatment site.
  • the exhausted medical interventional system 1 needs to first release the connection between the first element 61 and the second element 62, and then remove the second element 62, and then the The introducing sheath 45 is sleeved with the first element 61 so that the first element 61 can be used alone in the third state of the medical interventional system 1 .
  • the introducer sheath 45 can adopt the introducer sheath in the prior art, and the specific structure will not be repeated here.
  • an injection valve 452 communicating with the inner chamber of the guide sheath 45 can be provided, and a liquid (such as physiological saline) can be injected through the injection valve 452 to get rid of the air in the guide sheath 45 , to avoid bringing air into the patient's body and causing air embolism.
  • the liquid injection valve 452 can be a three-way valve in the prior art, which will not be repeated here.
  • the medical accessory 60 includes a first element 61 and a second element 62 detachably connected thereto.
  • the first element 61 can be used to protect and/or carry the medical implant 20 .
  • the medical accessory 60 can be used to remove air in the medical interventional system 1 where the medical implant 20 is located. Therefore, the medical interventional system 1 does not need to configure corresponding separate components for the protection and loading of the medical implant 20 and the exhaust of the whole system, so that the overall structure of the medical interventional system 1 is simple, easy to operate, and helps to reduce operation time.
  • the first sealing body 617, the second sealing body 627, the first on-off valve 612 and the second on-off valve 622 is preferably obtained from a material with excellent light-transmitting properties through machine addition molding, injection molding or extrusion molding.
  • the material with excellent light transmission performance can be, but not limited to, one or at least two of materials such as polymethyl methacrylate, polystyrene, polycarbonate, styrene-methyl methacrylate copolymer resin, etc. mixture.
  • Different parts of the first element 61 and the second element 62 can be made of the same material, or can be made of different materials.
  • first element 61 and second element 62 are made of highly transparent polycarbonate material and obtained by extrusion molding.
  • first element 61 and the second element 62 have high transparency, the first element 61 is sleeved on the distal end of the bending adjustment sheath 41, and the medical implant 20 can accommodate
  • the operator can clearly see the specific position of the medical implant 20 in the tube body 613 . It is not difficult to understand that when the medical implant 20 is not in the safe and effective position of the tube body 613 , the operator can directly observe and adjust the medical implant 20 to the safe and effective position in the tube body 613 .
  • the middle part of the tube body 613 can effectively protect the medical implant 20, that is, the tube body 613
  • the safe and effective position of refers to the middle position of the tube body 613 (for example, the position between the two ends of the tube body 613 occupying about 80% of the axial length).
  • the wall thickness of the tubular body 613 ranges from 0.3 mm to 1.5mm, the length range is 30mm-100mm.
  • the first sealing body 617 and the second sealing body 627 can be obtained by injection molding using but not limited to elastic materials such as nitrile rubber, thermoplastic polyurethane, silica gel, polytetrafluoroethylene, and nylon elastomer.
  • the first sealing body 617 and the second sealing body 627 are made of silica gel, and the hardness of the first sealing body 617 and the second sealing body 627 ranges from 30A to 60A.
  • the first barrel 611 may include a threaded section 6112 , a transition section 6114 and an inserting section 6116 sequentially connected from the proximal end to the distal end.
  • the threaded section 6112 is used for connecting the first cap body 615 and accommodating the first sealing body 617
  • the inserting section 6116 is used for connecting the tube body 613
  • the transition section 6114 is used for the medical implant 20 to transition into the tube body 613 .
  • the outer diameter of the threaded section 6112 is consistent from the proximal end to the distal end, and its outer peripheral wall is provided with external threads.
  • the first cap body 615 is a ring-shaped nut, at least on the inner wall of the distal end is provided with an internal thread corresponding to the external thread of the threaded section 6112, and the first cap body 615 is detachably connected to the threaded section 6112 by threaded connection. external.
  • the inner cavity of the threaded section 6112 is used to accommodate the first sealing body 617 (see FIG. 13 ).
  • the outer diameter of the inserting section 6116 is consistent from the proximal end to the distal end, and is smaller than the outer diameter of the threaded section 6112 .
  • the lumen of the insertion section 6116 is used to insert the proximal end of the tube body 613 .
  • the inner diameter of the insertion section 6116 is slightly larger than the outer diameter of the tube body 613 , so that after the proximal end of the tube body 613 is inserted into the lumen of the insertion section 6116 , the tube body There is a gap between the outer wall of 613 and the inner wall of the insertion section 6116, and by injecting glue into the gap, the tube body 613 and the insertion section 6116 can be bonded and fixed, thereby sealingly connecting the proximal end of the tube body 613 to the first The distal end of the barrel 611.
  • the outer diameter of the tube body 613 is 0.5mm-1.5mm smaller than the inner diameter of the inserting section 6116, so that there is enough injection when the tube body 613 and the first cylinder body 611 are inserted.
  • the glue space ensures the firmness of bonding between the pipe body 613 and the first cylinder body 611 and the sealing between the two. It is not difficult to understand that there should be a sufficient bonding length between the pipe body 613 and the insertion section 6116 (for example, 0.6mm-2.0mm), so as to ensure the reliability of the adhesion between the pipe body 613 and the insertion section 6116 .
  • the glue can be instant dry glue, medical glue or UV glue.
  • the outline of the tube body 613 is adapted to the inner cavity profile of the plug-in section 6116, the tube body 613 can be but not limited to a circular tube, a rectangular tube, a polygonal tube, and the cross-sectional shape of the inner cavity of the tube body 613 It can be, but not limited to, a circle, a rectangle, or a polygon, and it is not limited thereto.
  • the tube body 613 is a circular tube with a circular cross-section lumen.
  • the proximal end of the tube body 613 can be sealed and connected to the distal end of the first cylinder body 611 through threaded connection or snap connection. In other other embodiments, the tube body 613 can also be integrally formed with the first cylinder body 611 .
  • the outer wall of the insertion section 6116 is provided with external threads, and the inner cavity at the proximal end of the second cap body 625 is correspondingly provided with internal threads.
  • the second cap body 625 is sheathed on the inserting section 6116 through threaded connection, so as to realize the detachable connection between the distal end of the first cylinder body 611 and the proximal end of the second cap body 625 .
  • the connection between the inserting section 6116 and the second cap body 625 is through a double thread thread, and the number of turns of the thread can be 1-3 turns.
  • the inserting section 6116 and the second cap body 625 adopt a double-thread thread, and the stroke of the two relative rotations is twice the stroke of the single-thread thread, and the thread strength is twice that of the single-thread thread. It is more convenient and quick to operate, reduce operation time and improve connection strength.
  • the distal end of the first cylinder body 611 and the proximal end of the second cap body 625 may also be detachably connected in other ways, such as snap-fit connection.
  • the outer wall of the plug-in section 6116 of the first cylinder 611 is provided with at least two buckles at intervals along the circumference (preferably distributed symmetrically with respect to the central axis of the first cylinder 611),
  • the inner wall of the proximal end of the second cap body 625 corresponds to at least two buckles on the inserting section 6116 to provide at least two card slots, and each card slot includes a guide portion extending along the axial direction of the second cap body 625 and is compatible with the second cap body 625.
  • the guide part communicates with the stopping part extending along the circumferential direction of the second cap body 625 , wherein the groove width of the stopping part is slightly larger than the buckle width (for example, 0.05mm-0.10mm larger).
  • the stop portion of the slot acts to limit the buckle, and the first cylinder 611 and the second cap 625 will not move axially, and the gap between the width of the slot and the fit of the buckle is small (only 0.05mm-0.10mm). Relative rotation takes place, thereby realizing the detachable connection between the distal end of the first barrel 611 and the second cap 625 .
  • the transition section 6114 is connected between the threaded section 6112 and the inserting section 6116, and the inner cavity of the transition section 6114 is used for medical treatment passing through the first sealing body 617 in the threaded section 6112.
  • the implant 20 transitions through the insertion section 6116 and further into the tubular body 613 .
  • the inner diameter of the transition section 6114 gradually decreases from the proximal end to the distal end to be equal to or slightly smaller than the diameter of the tube body 613, and the transition section 6114 can serve as a receiving and guiding function, so that the medical implant 20 enters the tube body 613 smoothly.
  • the first cylinder 611 further includes a first short tube 6118 for connecting the first on-off valve 612 , and the first short tube 6118 protrudes radially from the outer circumference of the transition section 6114
  • the wall communicates with the lumen of the transition section 6114.
  • the first short pipe 6118 extends along a direction perpendicular to the central axis of the first barrel 611 and communicates with the first on-off valve 612 through a first connecting pipe (not labeled in the figure).
  • the first connecting pipe can be made of but not limited to polytetrafluoroethylene, thermoplastic polyurethane and other materials, and the first short pipe 6118 and the first connecting pipe are bonded together by medical glue, instant adhesive or UV glue. Wherein, the length of the first connecting pipe is moderate, usually 4mm-10mm.
  • the first on-off valve 612 can be directly connected to the first short pipe 6118 of the first cylinder 611, so that no first connecting pipe is required.
  • the first cylinder 611 may not be provided with the first short pipe 6118, but a port is directly opened on the outer peripheral wall of the transition section 6114, and the first on-off valve 612 is connected to the transition section through the first connecting pipe.
  • the port on the section 6114 or the first on-off valve 612 is directly connected to the port on the transition section 6114 so as to communicate with the inner cavity of the first barrel 611 , which is not limited.
  • the first sealing body 617 is disposed in the inner cavity of the threaded section 6112 .
  • the first sealing body 617 is a ring-shaped elastic sealing body, its proximal part is provided with a first inner hole 6172 in the shape of a tapered hole, and its distal part is provided with a connecting transition The lumen of segment 6114 and the groove of first bore 6172.
  • the outer diameter of the first sealing body 617 in the natural state is consistent from the proximal end to the distal end and is larger than the inner diameter of the threaded section 6112, and the first sealing body 617 can be elastically squeezed inside the threaded section 6112 In the cavity, the threaded section 6112 is pressed into contact with the entire peripheral wall of the first sealing body 617 to realize the sealing between the first sealing body 617 and the first cylindrical body 611 .
  • the proximal inner wall of the first cylinder 611 (that is, the inner wall of the screwed section 6112 ) is provided with a stopper 6119 , and the stopper 6119 is specifically formed on the screw
  • the step at the joint between the connecting section 6112 and the transition section 6114 (that is, the inner diameter of the screw section 6112 is at least larger than the inner diameter of the part where the transition section 6114 connects the screw section 6112)
  • the first cap body 615 is provided with abutment 6159, and the abutment 6159 It includes a connection section (not numbered in the figure) that is connected to the proximal end of the first cap body 615 and extends radially inward along the first cap body 615, and is connected to the side of the central axis of the connection section close to the first cap body 615
  • the first cap body 615 can move axially and distally relative to the first cylinder body 611 while rotating relative to the first cylinder body 611, so that The abutting section of the abutting portion 6159 compresses the proximal end of the first sealing body 617 in the axial direction, because the outer peripheral wall of the first sealing body 617 is bound by the inner wall of the threaded section 6112 of the first barrel 611, and the first sealing The distal end of the body 617 is abutted by the stop portion 6119, and the first sealing body 617 will be deformed radially toward the central axis of the first inner hole 6172 while being squeezed in the axial direction, thereby making the first inner hole
  • the 6172 has a reduced inside diameter.
  • the connection between the proximal end of the threaded section 6112 and the connecting section of the abutting portion 6159 There is a long enough axial distance between them, so that the abutment portion 6159 can move a long enough distance in the axial direction to the distal end, so that the abutment section of the abutment portion 6159 can produce sufficient axial extrusion on the first sealing body 617 pressure (such as 0.5mm-2.5mm), so as to ensure that the first sealing body 617 has a sufficient interference extrusion amount between the first sealing body 617 and the bending adjustment sheath 41 in the radial direction (for example, the unilateral extrusion amount of the first sealing body 617 is 0.5mm-1mm), to ensure that the aperture of the first inner hole 6172 can be reduced to hug the distal end
  • the outer diameter of the first sealing body 617 from the proximal end to the distal end may not be consistent, and the first sealing body 617 is a fixed part of a ring structure from the distal end (not numbered in the figure). It is composed of an extruding part (not labeled in the figure) with a truncated cone structure at the proximal end.
  • the outer diameter of the fixing part in a natural state is consistent and larger than the inner diameter of the screw-connection section 6112, and the outer diameter of the extruding part gradually increases from the proximal end to the distal end.
  • the fixing part is elastically squeezed in the inner cavity of the threaded section 6112 , so that the threaded section 6112 presses into contact with the outer peripheral wall of the fixing part of the first sealing body 617 to form a seal.
  • the outer peripheral wall of the extrusion part of the first sealing body 617 has a first tapered surface 6177, and the radial distance between the first tapered surface 6177 and the axis of the first sealing body 617 is from the proximal end of the first tapered surface 6177 to the first
  • the distal end of the tapered surface 6177 gradually increases, and the abutting portion 6159 of the first cap body 615 has a second tapered surface 6157 opposite to and adapted to the first tapered surface 6177 .
  • the taper of the first tapered surface 6177 and the second tapered surface 6157 can be consistent, that is, the first tapered surface 6177 and the second tapered surface 6157 are parallel, and the minimum radial dimension of the second tapered surface 6157 (that is, the proximal end of the top 6159 inner diameter) is smaller than the smallest radial dimension of the first tapered surface 6177 (that is, the outer diameter of the proximal end of the first sealing body 617). It can be understood that, in the embodiment shown in FIG.
  • the first cap body 615 can move axially and distally relative to the first cylinder body 611 while rotating relative to the first cylinder body 611 , so that the abutting portion 6159
  • the second tapered surface 6157 gradually squeezes the first tapered surface 6177 of the first sealing body 617. Since the first tapered surface 6177 and the second tapered surface 6157 are parallel to each other, the abutting top 6159 exerts pressure on the first sealing body 617.
  • the first cap body 615 can move axially relative to the first cylinder body 611 while rotating relative to the first cylinder body 611, and then compress the first sealing body 617 in the axial direction and/or radial direction, so as to The diameter of the first inner hole 6172 is reduced, so as to achieve tightness and sealing between the first sealing body 617 and the bending adjustment sheath 41 .
  • the first cap body 615 may be configured to rotate relative to the first cylinder 611 or to move axially relative to the first cylinder 611 so as to squeeze the first seal in the axial direction and/or radial direction.
  • the body 617 can also realize the tightness and sealing between the first sealing body 617 and the bending adjustment sheath 41, which will not be described in detail.
  • the first cap 615 detachably connected to the proximal end of the first cylinder 611 can be set to rotate and/or move axially relative to the first cylinder 611, and And/or radially squeeze the first sealing body 617 in the first cylindrical body 611, so that the diameter of the first inner hole 6172 is reduced, so as to realize the tightness and tightness between the first sealing body 617 and the bending adjustment sheath 41 seal.
  • the first element 61 is not connected to the second element. 62.
  • the first element 61 is sleeved on the distal end of the bending adjustment sheath 41 (specifically, the distal end of the bending adjustment sheath tube 414). Specifically, as shown in FIGS.
  • the distal end of the delivery sheath 43 (specifically, the distal end of the delivery sheath 434 ) is detachably connected to the medical implant 20 and the medical implant 20 exposes the bending sheath 414
  • the operator needs to retract the medical implant 20 into the lumen of the tubular body 613 of the first element 61, before the medical implant 20 enters the safe and effective position in the tubular body 613, the screw cap
  • the first cap body 615 of the structure is in the initial non-tightened state, that is, the first cap body 615 has not rotated relative to the first cylinder body 611.
  • the first sealing body 617 is not subjected to extrusion force in the axial direction, and the first sealing body 617
  • the first inner hole 6172 remains unchanged, the first sealing body 617 does not hold the bending adjustment sheath 414 tightly, and the first element 61 can move on the bending adjustment sheath 414 without resistance.
  • the body 611 moves axially to the distal end, and the first cap body 615 squeezes the first sealing body 617 to reduce the diameter of the first inner hole 6172, so that the first sealing body 617 hugs the adjustable bending sheath tube 414, thereby
  • the first element 61 is fixed on the distal end of the bending adjustment sheath 414, and the medical implant 20 is accommodated in the safe and effective position of the tube body 613, and the tube body 613 can effectively protect the medical implant 20 in all links before the operation No damage.
  • the second cylindrical body 621 is a hollow tubular body with a circular cross-section inner cavity, and its inner diameter is larger than the outer diameter of the tubular body 613 ( For example, larger than 0.5mm-3.5mm), so that the tube body 613 can be inserted into the inner cavity of the second cylinder body 621 .
  • the axial length of the second cylindrical body 621 is longer than the axial length of the portion of the tubular body 613 exposed to the first cylindrical body 611 (for example, 3mm-15mm long), so that the portion of the tubular body 613 exposed to the first cylindrical body 611 can be It is completely accommodated in the inner cavity of the second cylinder 621 .
  • the distal end of the second cylindrical body 621 is provided with a second short tube (not labeled in the figure) communicating with its inner cavity, and the second short tube is connected to the second connecting tube (not labeled in the figure)
  • the second on-off valve 622 communicates.
  • the second on-off valve 622 can also be directly connected to the distal end of the second cylinder body 621 or other reasonable positions, so that there is no need to set a second connecting pipe;
  • the cylinder body 621 may also not be provided with a second short tube, and a connection port may be directly provided at its distal end or other reasonable positions, and the second on-off valve 622 is connected to the port or the second on-off valve 622 through a second connecting tube. It is directly connected to the port so as to communicate with the inner chamber of the second cylinder 621 , which is not limited.
  • the second sealing body 627 can be an annular elastic sealing body, and the second sealing body 627 is arranged in the inner cavity of the proximal end of the second cylinder body 621 middle.
  • the second sealing body 627 in the natural state has the same outer diameter from the proximal end to the distal end and is larger than the inner diameter of the proximal inner cavity of the second barrel 621, and the second sealing body 627 can be elastically squeezed on the second barrel In the inner cavity of the proximal end of the body 621, the second cylindrical body 621 is pressed into contact with the outer peripheral wall of the second sealing body 627 to form a seal.
  • the diameter of the second inner hole 6272 of the second sealing body 627 is smaller than the outer diameter of the tube body 613 , for example, it may be 1mm-3mm smaller.
  • the resistance of the tube body 613 entering the second cylinder body 621 will not be too large , and when the tube body 613 is inserted into the second cylinder body 621 and passes through the second inner hole 6272, there is an interference fit between the tube body 613 and the second sealing body 627, thereby ensuring that the second sealing body 627 has a positive impact on the tube body 613. Has a good sealing effect.
  • the inner wall of the proximal end of the second cylinder 621 is provided with an annular avoidance groove, and the annular escape groove is along the groove bottom of the second cylinder 621 in the axial direction.
  • the second cap 625 includes a nut at the proximal end and a cannula connected to the distal end of the nut, and the second cap 625 is connected to the second barrel 621, the distal end of the intubation tube is accommodated in the annular avoidance groove at the proximal end of the second cylinder 621, and the distal end of the intubation tube abuts against the proximal end of the second sealing body 627, thereby preventing the second sealing body from 627 moves axially proximally.
  • the opposite ends of the second sealing body 627 are respectively abutted by the stopper step of the second cylinder body 621 and the insertion tube of the second cap body 625, which limits the movement of the second sealing body 627 in the axial direction, which is beneficial to improve the second sealing body 627.
  • the stability of the sealing body 627 disposed in the second cylindrical body 621 further ensures the sealing reliability between the second sealing body 627 and the tube body 613 .
  • the inner diameter of the annular escape groove of the second cylindrical body 621 is larger than the outer diameter of the intubation tube of the second cap body 625, and the circumferential side of the annular escape groove There is a gap between the wall and the outer peripheral wall of the intubation tube, and the second cylinder 621 and the second cap 625 are bonded together by injecting glue into the gap, thereby connecting the second cap 625 to the second cylinder 621 the proximal end.
  • the second sealing body 627 can also be bonded together with the second cylinder body 621 and/or the second cap body 625 by glue, which can improve the stability of the second sealing body 627 .
  • the glue can be instant dry glue, medical glue or UV glue.
  • the outer peripheral wall of the distal end of the cannula is provided with an annular receiving groove
  • the proximal end of the second sealing body 627 is provided with an annular tongue edge.
  • the circumferential side wall of the annular avoidance groove can be provided with internal threads, and the outer peripheral wall of the cannula can be provided with external threads correspondingly, and the second cap body 625 can be connected to the proximal end of the second cylinder body 621 by threaded connection.
  • the terminal is preferably connected by a double-wire thread, the threaded connection is convenient for disassembly, and the disassembly speed is faster.
  • the second sealing body 627 can also be arranged in the intubation tube of the second cap body 625 by means of bonding, etc., and the second sealing body 627 and the second inner hole can also be realized.
  • the seal between the tube bodies 613 of 6272 will not be described in detail.
  • the first element 61 and the second element 62 act in combination, through the first on-off valve 612, the second on-off valve 622, the first exhaust valve 412 and the second exhaust
  • the combined use of the valve 432 can remove the air in the medical interventional system 1 before the operation, so as to avoid air embolism caused by the air in the medical interventional system 1 entering the blood vessel.
  • the present application also provides a method for exhausting the medical interventional system 1 , which includes steps S1 and S2 , which are described in detail as follows.
  • Step S1 As shown in Figure 4 and Figure 5, the first element 61 is sleeved on the distal end of the bending adjustment sheath 41 (specifically, the distal end of the bending adjustment sheath 414) and connected to the second element 62, so that the bending adjustment The distal end of the sheath 41 passes through the first inner hole 6172 and is tightly embraced by the first sealing body 617 , and the medical implant 20 is accommodated in the inner cavity of the tube body 613 .
  • the tube body 613 extends into the inner cavity of the second cylinder body 621, and is detachably connected to the distal end of the delivery sheath 43 (specifically
  • the medical implant 20 that is the distal end of the delivery sheath tube 434) is also located in the second cylinder body 621 with the tube body 613, and a seal is formed between the tube body 613 and the inner chamber of the second cylinder body 621, so that the second cylinder body 621
  • the lumen of the cylinder body 621 i.e. the lumen of the second element 62
  • the lumen of the first cylinder body 611 i.e. the lumen of the first element 61
  • the lumen of the bending adjustment sheath 41 and the lumen of the delivery sheath 43 Seal connection.
  • Step S2 Keep the second on-off valve 622 sealingly connected to the inner cavity of the second element 62, the first exhaust valve 412 sealingly connected to the inner cavity of the bending adjustment sheath 41, and the second exhaust valve 432 sealingly connected to the inner cavity of the delivery sheath 43 Any two of them are closed, and the remaining one is opened together with the first on-off valve 612 that is sealingly connected to the inner cavity of the first element 61, and liquid (not limited to physiological saline) is injected into the first on-off valve 612 until the liquid is released from the first on-off valve 612. The remaining one of the above flows out.
  • the operator sequentially opens the first on-off valve 612 and the second on-off valve 622, the first exhaust valve 412, and the second exhaust valve 432 together to serve as liquid
  • the injection valve and the outflow valve can sequentially discharge the air in the medical accessory 60 , the bending adjustment sheath 41 and the delivery sheath 43 .
  • step S2 in the exhaust method of the medical interventional system 1 includes the following exhaust operations in sequence.
  • the first step the exhaust path of A1-A2 as shown in Figure 20, when the first on-off valve 612, the second on-off valve 622, the first exhaust valve 412 and the second exhaust valve 432 are all closed , place the second on-off valve 622 at the highest position (the highest position in the direction of gravity), open the first on-off valve 612 and the second on-off valve 622, and inject liquid into the first on-off valve 612 until the liquid
  • the second on-off valve 622 flows out to discharge the air in the medical accessory 60 , that is, to remove the air in the first element 61 and the second element 62 .
  • the operator needs to control the rotation of the first cap 615 relative to the first cylinder 611 to tighten the first cap 615 so that the first cap 615 squeezes the first cylinder
  • the first sealing body 617 in the body 611 further reduces the aperture of the first inner hole 6172 to ensure that the first sealing body 617 hugs the distal end of the bending adjustment sheath 41 tightly, while the second sealing body 627 seals the outer periphery of the tube body 613 .
  • the operator needs to close the second on-off valve 622 first and then close the first on-off valve 612, and stop injecting the liquid only after confirming that the first on-off valve 612 is closed. Air can be prevented from being carried into the interior of the medical accessory 60 .
  • the operation The operator can observe whether there is residual air in the tube body 613 for accommodating the medical implant 20. If air bubbles are still attached to the surface of the inner cavity of the tube body 613, the first tube body 611 and the tube body 613 can be lightly flicked, Make the air bubbles gather together, and repeat the exhaust operation of the first step until the liquid flows out from the second on-off valve 622 and no air bubbles appear, so as to ensure that the air in the inner cavity of the medical accessory 60 is completely exhausted.
  • the second step the exhaust path of B1-B2 as shown in Figure 21, after completing the exhaust operation of the first step, the first on-off valve 612, the second on-off valve 622, the first exhaust valve 412 and When the second exhaust valves 432 are all closed, place the first exhaust valve 412 at the highest position, open the first on-off valve 612 and the first exhaust valve 412, and inject liquid into the first on-off valve 612 until The liquid flows out from the first exhaust valve 412 to exhaust the air in the bending adjustment sheath 41 .
  • the operator when the liquid flows out from the first exhaust valve 412, the operator needs to close the first exhaust valve 412 first and then close the first on-off valve 612, and then stop injecting the liquid after confirming that the first on-off valve 612 is closed. Air can be prevented from being brought into the inner cavity of the bending adjustment sheath 41 .
  • the bending handle 416 is also provided with a transparent part, therefore, after completing the exhaust operation of the second step, the operator can observe whether the inner cavity of the bending handle 416 has residual Air bubbles, if there are air bubbles attached to the surface of the inner cavity of the bending handle 416, the outer shell of the bending handle 416 can be lightly flicked to make the air bubbles gather together, and repeat the exhaust operation of the second step until the first exhaust valve 412 There is liquid flowing out and no air bubbles appear, thereby ensuring that the air in the cavity of the bending adjustment sheath 41 is completely exhausted.
  • the third step the exhaust path of C1-C2 as shown in Figure 22, after completing the exhaust operation of the second step, after the first on-off valve 612, the second on-off valve 622, the first exhaust valve 412 and When the second exhaust valves 432 are all closed, place the second exhaust valve 432 at the highest position, open the first on-off valve 612 and the second exhaust valve 432, and inject liquid into the first on-off valve 612 until Fluid flows out of the second exhaust valve 432 to expel the air within the delivery sheath 43 .
  • the operator when the liquid flows out from the second exhaust valve 432, the operator needs to close the second exhaust valve 432 first and then close the first on-off valve 612, and then stop injecting the liquid after confirming that the first on-off valve 612 is closed.
  • the entrainment of air into the lumen of the delivery sheath 43 can be avoided.
  • an observation window 4361 made of a transparent material is usually provided on the delivery handle 436.
  • the operator can observe whether the inner cavity of the delivery handle 436 is still intact through the observation window 4361. If there are residual air bubbles, if there are air bubbles attached to the surface of the inner cavity of the delivery handle 436, lightly flick the outer shell of the delivery handle 436 to make the air bubbles gather together, and repeat the exhaust operation in the third step until the second exhaust valve 432 has The liquid flows out without the appearance of air bubbles, thereby ensuring that the lumen of the delivery sheath 43 is purged of air.
  • the operator can observe whether there are residual air bubbles in the medical accessory 60, the bending handle 416, and the delivery handle 436. If there are residual air bubbles, the above three-step exhaust operation needs to be repeated until the medical interventional system 1 The inner cavity air is exhausted.
  • the step S2 in the exhaust method of the medical interventional system 1 can also discharge the medical aids in other order.
  • the air in the bending sheath 41 and the delivery sheath 43 for example, the air in the bending sheath 41 can be discharged first, then the air in the delivery sheath 43 can be discharged, and finally the air in the medical auxiliary part 60 can be discharged, as long as it can be passed repeatedly Several exhaust operations are enough to ensure that the air in the inner cavity of the medical interventional system 1 is exhausted, and there is no limitation on this.
  • the operator can release the connection between the first element 61 and the second element 62 and remove the Lower the second element 62, and then socket the introducer sheath 45 with the first element 61, so that the medical implant 20 is loaded into the introducer sheath 45, and the operator establishes it through the introducer sheath 45 of the delivery device 40
  • the intervention channel can push the medical implant 20 to the predetermined treatment site.
  • the introducer sheath 45 when the introducer sheath 45 is socketed with the first element 61 , the distal end of the tube body 613 is inserted into the proximal lumen of the introducer sheath 45 and accommodated in the tube body
  • the medical implant 20 in 613 also enters the proximal lumen of the introducer sheath 45 .
  • a sealing gasket 451 and a transition piece 453 are provided inside the introducer sheath 45 .
  • the sealing gasket 451 is made of an elastic material (such as but not limited to silicone), and has a slit (which may be but not limited to a cross-shaped incision or a circular slit), and the sealing gasket 451 is used for the tube body 613 to pass through and The outer circumference of the tube body 613 is sealed, so as to realize the sealed connection between the tube body 613 and the introducing sheath 45 .
  • the transition piece 453 is disposed on the distal side of the gasket 451 and is used for abutting against the distal end of the tube body 613 so as to limit the position.
  • the transition piece 453 is provided with a tapered hole, the diameter of the tapered hole gradually decreases from the proximal end to the distal end, and the minimum diameter of the tapered hole is smaller than the outer diameter of the tube body 613, and the distal end of the tube body 613 The end extends into the transition piece 453 from the proximal end of the taper hole and abuts against the inner wall of the transition piece 453 .
  • the pipe body 613 can conveniently extend into the transition piece 453 through the tapered hole, and can achieve buffer contact with the transition piece 453 , so as to avoid hard contact and help protect the pipe body 613 .
  • the second element 62 in the exhausted medical intervention system 1 is removed from the distal end of the first element 61, and the The tube body 613 of the medical implant 20 passes through the incision position of the sealing gasket 451, and continues to push the first element 61 forward until the distal end of the tube body 613 reaches the position of the transition piece 453 in the guide sheath 45.
  • the first element 61 establishes a safe channel for the medical implant 20 to enter the inner cavity of the introducer sheath 45, after which the first cap body 615 of the first element 61 can be slightly loosened to properly reduce the first sealing body 617
  • the tightness of the bending adjustment sheath 414 enables the bending adjustment sheath 414 to move relative to the first sealing body 617 under the premise of maintaining the seal, and the medical implant 20 is driven by the bending adjustment sheath 41 and the delivery sheath 43 and enters smoothly.
  • the medical implant 20 is smoothly delivered to the designated position in the patient's body (such as the left atrium) through the delivery sheath 43 and the bending sheath 41 ), and then by manipulating each handle, the medical implant 20 is released and placed in the patient's body, thereby completing the corresponding interventional operation (such as mitral valve edge-to-edge repair).
  • each sheath tube which can be connected to the first on-off valve 612 by connecting a A negative pressure device (not limited to a syringe) applies a negative pressure to each sheath to extract excess air in each sheath.
  • the lumen of the first cylinder 611 communicates with the lumen of the guide sheath 45, and the distal end of the guide sheath 45 is located in a designated position (such as the left atrium, aorta) in the patient's body, and can pass through the first on-off valve 612
  • a designated position such as the left atrium, aorta
  • the patient's physiological parameters can be monitored during the operation, such as intravascular blood pressure or the heart's atrial-ventricular pressure difference, and the medical implant 20 can be judged according to the patient's physiological parameters implantation effect.
  • the introducer sheath 45 also has other components, such as an end cap 458 that is detachably connected (such as but not limited to threaded connection) to the proximal end of the guide handle 456 (see FIG. 10 ), and the O-rings provided between the sealing gasket 451 and the transition piece 453, etc., wherein the end cover 458 is provided with a through hole for the pipe body 613 to pass through, which will not be repeated here.
  • an end cap 458 that is detachably connected (such as but not limited to threaded connection) to the proximal end of the guide handle 456 (see FIG. 10 ), and the O-rings provided between the sealing gasket 451 and the transition piece 453, etc., wherein the end cover 458 is provided with a through hole for the pipe body 613 to pass through, which will not be repeated here.
  • the medical accessory 60 includes a first element 61 and a second element 62 detachably connected thereto.
  • the first element 61 can be used to protect and/or carry the medical implant 20 .
  • the medical accessory 60 can be used to remove air in the medical interventional system 1 where the medical implant 20 is located. Therefore, the medical interventional system 1 does not need to configure corresponding separate components for the protection and loading of the medical implant 20 and the exhaust of the whole system, so that the overall structure of the medical interventional system 1 is simple, easy to operate, and helps to reduce operation time.

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Abstract

一种医用辅件（60）、医用介入系统（1）及其排气方法，医用辅件（60）包括第一元件（61）及第二元件（62）；第一元件（61）包括第一筒体（611）、密封连接第一筒体（611）远端的管体（613）、可拆卸连接第一筒体（611）近端的第一帽体（615）、设于第一筒体（611）内的第一密封体（617）以及密封连接第一筒体（611）内腔的第一通闭阀（612）；第一密封体（617）具有第一内孔（6172），第一帽体（615）可选择性地挤压第一密封体（617），以使第一内孔（6172）的孔径减小；第二元件（62）包括第二筒体（621）及密封连接第二筒体（621）内腔的第二通闭阀（622）；第一筒体（611）的远端与第二筒体（621）的近端可拆卸连接，在连接状态下，管体（613）伸入第二筒体（621）的内腔中，且管体（613）与第二筒体（621）的内腔之间形成密封；第一元件（61）可单独使用以保护和/或装载医用植入件（20），也能够和第二元件（62）组合使用以排除医用植入件（20）所在的医用介入系统（1）内的空气。

Description

医用辅件、医用介入系统及其排气方法
本申请要求于2021年12月31日提交中国专利局、申请号为2021116800558、申请名称为“医用辅件、医用介入系统及其排气方法”的中国专利申请的优先权，同时要求于2022年3月1日提交中国专利局、申请号为2022101999898、申请名称为“医用辅件、医用介入系统及其排气方法”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，尤其涉及一种医用辅件、医用介入系统及其排气方法。
背景技术
二尖瓣、三尖瓣等房室瓣是心脏内的单向阀，正常健康的房室瓣可以控制血液从心房流到心室，同时避免血液从心室流到心房。例如：二尖瓣是位于心脏左心房与左心室之间的单向阀，可以控制血液从左心房流到左心室，同时避免血液从左心室流到左心房；三尖瓣是位于心脏右心房与右心室之间的单向阀，可以控制血液从右心房流到右心室，同时避免血液从右心室流到右心房。二尖瓣包括前叶与后叶，三尖瓣包括前叶、后叶以及隔叶。在正常情况下，左心室或者右心室收缩时，二尖瓣或者三尖瓣的任意相邻两片瓣叶的边缘完全对合，避免血液从心室流到心房。若瓣叶或其相关结构发生器质性改变或功能性改变，如腱索部分断裂，造成二尖瓣或三尖瓣的相邻瓣叶对合不良，当左心室或右心室收缩时，二尖瓣或三尖瓣便不能完全关闭，导致血液从心室反流至心房，从而引起一系列的病理生理改变，称为“二尖瓣反流”或“三尖瓣反流”。
许多出现“二尖瓣反流”或者“三尖瓣反流”的高龄患者不适用于外科手术进行修复治疗，介入治疗的手术方法应运而生，并经过近20年的发展，介入治疗被广泛用于心脏疾病临床治疗中，该治疗方法逐渐成为医学上关注的焦点。近年来，随着介入治疗的不断发展，各式各样的医疗器械被用于二尖瓣或者三尖瓣的临床治疗中。现有技术中已公开了多种植入心脏、用于夹持二尖瓣或者三尖瓣以实施缘对缘修复的植入件(瓣膜夹)，能够有效减轻甚至消除反流。
植入件需要借助其所在的医用介入系统达到预定位点实施植入。在医用介入系统的运输以及准备过程中，需要对植入件进行保护，以防止植入件受损失效；在医用介入系统使用之前，需要对整个系统进行严格的排气操作，以防止将空气代入人体内进而引发空气栓塞。此外，在医用介入系统使用过程中，还需要对植入件进行装载操作。
然而，现有技术中，通常是为植入件保护、系统排气、及植入件装载分别配置相应的单功能独立部件，导致医用介入系统的整体部件较多，操作不便，而且会延长手术时间。
发明内容
本申请的目的在于提供一种医用辅件、医用介入系统及其排气方法，该医用辅件可用于保护和/或装载医用植入件以及医用介入系统的排气。
为实现上述目的，第一方面，本申请提供一种医用辅件，包括第一元件及第二元件。所述第一元件包括第一筒体、密封连接所述第一筒体远端的管体、可拆卸连接所述第一筒体近端的第一帽体、设于所述第一筒体内的第一密封体以及密封连接所述第一筒体的内腔的第一通闭阀。其中，所述第一密封体具有第一内孔，所述第一帽体可选择性地挤压所述第一密封体，以使得所述第一内孔的孔径减小。所述第二元件包括第二筒体及密封连接所述第二筒体的内腔的第二通闭阀。所述第一筒体的远端与所述第二筒体的近端可拆卸连接，在连接状态下，所述管体伸入所述第二筒体的内腔中，且所述管体与所述第二筒体的内腔之间形成密封。
第二方面，本申请提供一种医用介入系统，包括医用植入件、输送装置及如上所述的医用辅件。所述输送装置包括调弯鞘与输送鞘，所述输送鞘活动穿设于所述调弯鞘内，所述输送鞘的远端可拆卸连接所述医用植入件，其中，所述调弯鞘上设有第一排气阀，所述输送鞘上设有第二排气阀。第一状态下，所述第一元件套接于所述调弯鞘的远端上，所述调弯鞘的远端穿过所述第一内孔且被所述第一密封体抱紧，所述医用植入件容置于所述管体的内腔中，所述第一元件单独作用，以保护所述医用植入件。第二状态下，所述第一元件套接于所述调弯鞘的远端上并连接所述第二元件，所述调弯鞘的远端穿过所述第一内孔且被所述第一密封体抱紧，所述医用植入件容置于所述管体的内腔中；所述第一元件与所述第二元件组合作用，以通过所述第一通闭阀、所述第二通闭阀、所述第一排气阀及所述第二排气阀排除所述医用介入系统内的空气。
第三方面，本申请还提供一种如上所述的医用介入系统的排气方法，所述排气方法至少包括以下操作：将所述第一元件套接于所述调弯鞘的远端上并连接所述第二元件，使所述调弯鞘的远端穿过所述第一内孔且被所述第一密封体抱紧，所述医用植入件容置于所述管体的内腔中；保持所述第二通闭阀、所述第一排气阀及所述第二排气阀中的任意两者关闭，剩余的一者与所述第一通闭阀一起打开，向所述第一通闭阀注入液体，直至所述液体从所述剩余的一者流出。
本申请提供的医用辅件、医用介入系统及其排气方法中，所述医用辅件包括第一元件及与其可拆卸连接的第二元件，所述第一元件单独使用时，所述第一元件可以用于保护和/或装载医用植入件，所述第一元件和所述第二元件装配成一个整体组合使用时，所述医用辅件可以用于排除所述医用介入系统内的空气，因此，所述医用介入系统不需要为所述医用植入件的保护、装载以及整个系统的排气分别配置相应的单独部件，使得所述医用介入系统的整体结构简单，操作方便，有利于减少手术时间。
附图说明
图1是本申请一实施方式提供的医用介入系统在第一状态下的结构示意图。
图2是图1中的II部分的放大示意图。
图3是图2中沿III-III方向的剖视图。
图4是图1中的医用介入系统在第二状态下的结构示意图。
图5是图4中的V部分的放大示意图。
图6是图5中的第二元件的轴向剖视图。
图7是图6中的VII部分的放大示意图。
图8是图1中的医用介入系统在第三状态下的结构示意图。
图9是图8中的医用介入系统的局部轴向剖视图。
图10是图9中的X部分的放大示意图。
图11是本申请一实施方式提供的第一元件的主视图。
图12是图11中的第一元件的立体分解结构示意图。
图13是图11中沿XIII-XIII方向的剖视图。
图14是图13中的第一帽体与第一筒体分离后的示意图。
图15是图13中的XV部分的放大示意图。
图16是本申请另一实施方式提供的第一筒体、第一帽体及第一密封件的局部剖视图。
图17是本申请一实施方式提供的第二元件的主视图。
图18是图17中的第二元件的立体分解结构示意图。
图19是本申请一实施方式提供的医用介入系统的排气方法的流程示意图。
图20是医用辅件的排气路径示意图。
图21是调弯鞘的排气路径示意图。
图22是输送鞘的排气路径示意图。
具体实施方式
下面将结合本申请实施方式中的附图，对本申请实施方式中的技术方案进行清楚、完整地描述，显然，所描述的实施方式仅仅是本申请的一部分实施方式，而不是全部的实施方式。基于本申请中的实施方式，本领域普通技术人员在没有付出创造性劳动的前提下所获得的所有其他实施方式，都属于本申请保护的范围。
此外，以下各实施方式的说明是参考附加的图示，用以例示本申请可用以实施的特定实施方式。本申请中所提到的方向用语，例如，“上”、“下”、“前”、“后”、“左”、“右”、“内”、“外”、“侧面”等，仅是参考附加图示的方向，因此，所使用的方向用语是为了更好、更清楚地说明及理解本申请，而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作，因此不能理解为对本申请的限制。
需要说明的是，为了更加清楚地描述医用辅件及医用介入系统的结构，本申请在说明书中所述的限定术语“近端”及“远端”为介入医疗领域的惯用术语。具体地，对于腔内介入手术使用的器械来说，其“远端”表示手术操作过程中远离操作者的一端，而其“近端”表示手术操作过程中靠近操作者的一端。再者，将柱体、管体等一类物体的旋转中心轴的方向定义为轴向；周向为围绕柱体、管体等一类物体的轴线的方向(垂直于轴线，同时垂直于截面半径)；径向就是沿直径或者半径的方向。
值得注意的是，无论“近端”、“远端”、“一端”、“另一端”、“第一端”、“第二端”、“初始端”、“末端”、“两端”、“头端”、“上端”、“下端”等词语中所出现的“端”，并不仅限于端头、端点或者端面，也包括自端头、端点、或者端面在端头、端点、或者端面所属元件上延伸一段轴向距离和/或径向距离的部位。除非另有定义，本申请所使用的所有的技术和科学术语与属于本申请的技术领域的技术人员通常理解的含义相同。本申请在说明书中所使用的惯用术语只是为了描述具体实施方式的目的，并不能理解为对本申请的限制。
请结合图1至图5，本申请提供一种医用介入系统1，包括医用植入件20、输送装置40以及医用辅件60。医用植入件20可以是但不限于瓣膜夹、血管支架等，输送装置40用于将医用植入件20输送至患者体内，医用辅件60用于保护和/或装载医用植入件20以及医用介入系统1的排气。
具体地，如图1及图4所示，在一些实施方式中，输送装置40可包括调弯鞘41和输送鞘43。输送鞘43活动穿设于调弯鞘41内，输送鞘43的远端可拆卸连接医用植入件20。其中，调弯鞘41和输送鞘43上分别设有第一排气阀412和第二排气阀432，第一排气阀412具有与调弯鞘41的内腔连通的连通状态以及与调弯鞘41的内腔隔绝的关闭状态，第二排气阀432具有与输送鞘43的内腔连通的连通状态以及与输送鞘43的内腔隔绝的关闭状态。更具体地，调弯鞘41包括调弯鞘管414及连接于调弯鞘管414近端的调弯手柄416，输送鞘43包括输送鞘管434及连接于输送鞘管434近端的输送手柄436。输送鞘管434自调弯手柄416的近端穿入调弯鞘管414，且输送鞘管434的远端可自调弯鞘管414的远端伸出，并可拆卸连接医用植入件20。第一排气阀412和第二排气阀432分别设置于调弯手柄416和输送手柄436上。调弯鞘41和输送鞘43可以采用现有技术中的调弯鞘和输送鞘，第一排气阀412及第二排气阀432均可以采用现有技术中的三通阀，调弯鞘41、输送鞘43、第一排气阀412及第二排气阀432的具体结构在此不作赘述。
在本申请中，医用辅件60包括第一元件61以及第二元件62。具体地，请结合图1至图3，在一些实施方式中，第一元件61包括第一筒体611、密封连接第一筒体611远端的管体613、可拆卸连接第一筒体611近端的第一帽体615、设于第一筒体611内的第一密封体617以及密封连接第一筒体611的内腔的第一通闭阀612，第一通闭阀612具有与第一元件61的内腔连通的连通状态以及与第一元件61的内腔隔绝的关闭状态。其中，如图3所示，第一密封体617具有第一内孔6172，第一帽体615可选择性地挤压第一密封体617，以使得第一内孔6172的孔径减小。请结合图4及图5，在一些实施方式中，第二元件62包括第二筒体621以及密封连接第二筒体621的内腔的第二通闭阀622，第二通闭阀622具有与第二元件62的内腔连通的连通状态以及与第二元件62的内腔隔绝的关闭状态。其中，与第一排气阀412以及第二排气阀432类似，第一通闭阀612和第二通闭阀622同样可以采用现有技术中的三通阀，其具体结构在此也不作赘述。
如图5所示，本申请提供的医用辅件60中，第一筒体611的远端能够与第二筒体621的近端可拆卸连接，使得第一元件61与第二元件62装配成一个整体，在连接状态下，管体613伸入第二筒体621的内腔中，且管体613与第二筒体621的内腔之间形成密封。优选地，请结合图5至图7，在一些实施方式中，第二元件62还包括连接于第二筒体621近端的第二帽体625及设于第二筒体621或第二帽体625内的第二密封体627，第二密封体627具有第二内孔6272。在图5至图7所示的实施方式中，第一筒体611的远端与第二帽体625的近端可拆卸连接以实现第一元件61和第二元件62的连接，在连接状态下，管体613的远端穿过第二内孔6272并与第二密封体627过盈配合，使得管体613与第二筒体621的内腔之间形成密封。
在本申请中，第一元件61与第二元件62相互分离时和装配成一个整体时分别用于医用介入系统1的不同状态中，从而实现不同的功能。
具体地，请结合图1至图3，医用介入系统1处于第一状态时，第一元件61套接于调弯鞘41的远端(即调弯鞘管414的远端)上，调弯鞘41的远端穿过第一密封体617的第一内孔6172且被第一密封体617抱紧，管体613的内腔套设于医用植入件20外，第一元件61单独作用，以保护容置于管体613内腔中的医用植入件20。其中，医用介入系统1处于第一状态时主要用于其包装、灭菌及运输等过程。
需要说明的是，自然状态下，第一内孔6172的孔径等于或者大于调弯鞘41的远端的外径(具体为调弯鞘管414的远端外径)，以供调弯鞘41的远端穿过第一内孔6172；管体613 的内径等于或者大于调弯鞘41的远端的外径，以供穿过第一内孔6172的调弯鞘41进一步穿入管体613的内腔。优选地，在一些实施方式中，第一内孔6172的孔径要比调弯鞘41的远端的外径大(例如大2mm-7mm)，管体613的内径也要比调弯鞘41的远端的外径大(例如大0.2mm-1mm)，便于调弯鞘41的远端快速穿过第一内孔6172并穿入管体613的内腔。进一步优选地，如图3所示，在一些实施方式中，第一内孔6172为锥孔，锥孔的内径自其近端至其远端逐渐减小，锥孔具有较大的穿入口，更方便于调弯鞘41的远端穿过。
可以理解的是，当第一帽体615可选择性地挤压第一密封体617以使得第一内孔6172的直径减小时，第一密封体617即可抱紧穿过第一内孔6172的调弯鞘41的远端，从而实现第一元件61与调弯鞘41之间的密封；当第一密封体617未被第一帽体615挤压时，第一内孔6172和管体613均与调弯鞘41之间存在间隙，使得第一元件61能够在调弯鞘41上无阻力地沿着调弯鞘41的轴向移动。
还需要说明的是，第一筒体611的内腔的最小内径大于医用植入件20的最大外径，且小于或者等于管体613的内径，使得管体613与第一筒体611之间不会出现凸出于第一筒体611的内壁的台阶，有利于医用植入件20顺畅地经由第一筒体611的内腔进入管体613内，并且医用植入件20在管体613内不会受到径向挤压，防止损坏医用植入件20的结构。例如，在一种可能的实施方式中，管体613的内径为3mm-8mm，管体613的内径比医用植入件20的最大外径大0.5mm-2mm，且管体613的内径比第一筒体611的最小内径大0.2mm-1mm。
请结合图4及图5，医用介入系统1处于第二状态时，第一元件61套接于调弯鞘41的远端上并连接第二元件62，调弯鞘41的远端穿过第一密封体617的第一内孔6172且被第一密封体617抱紧，医用植入件20容置于管体613的内腔中，第一元件61与第二元件62组合作用，以通过第一通闭阀612、第二通闭阀622、第一排气阀412及第二排气阀432排除医用介入系统1内的空气。其中，医用介入系统1处于第二状态时主要用于其排气的过程，具体的排气方法在后续内容中会进行详细描述。
进一步地，请结合图8至图10，在一些实施方式中，输送装置40还包括导引鞘45，导引鞘45包括导引鞘管454及连接于导引鞘管454近端的导引手柄456，导引鞘45用于建立介入通道。调弯鞘管414经导引手柄456活动穿设于导引鞘管454内，从而通过导引鞘45建立的介入通道将医用植入件20植入患者体内。也即是说，在一些实施方式中，医用介入系统1还具有用于将医用植入件20输送至患者体内的第三状态。
具体地，如图8至图10所示，医用介入系统1处于第三状态时，第一元件61套接于调弯鞘41的远端上，并且调弯鞘41的远端穿过第一密封体617的第一内孔6172且被第一密封体617抱紧，医用植入件20容置于管体613的内腔中，第一元件61单独作用，管体613穿插入导引鞘45内，使得医用植入件20装载入导引鞘45内，此后，保持第一元件61与导引鞘45的相对位置，同步推送调弯鞘41及输送鞘43，输送装置40便通过导引鞘45建立的介入通道将医用植入件20推送至预定治疗位点。需要说明的是，当导引鞘45的介入通道建立完毕后，完成排气的医用介入系统1需要先解除第一元件61与第二元件62的连接，取下第二元件62，然后才能将导引鞘45与第一元件61进行套接，以使第一元件61在医用介入系统1的第三状态中单独使用。
其中，导引鞘45可以采用现有技术中的导引鞘，具体结构在此不作赘述。可选地，导引鞘45的导引手柄456上可以设置连通导引鞘45内腔的注液阀452，通过注液阀452注入液体(例如生理盐水)以排除导引鞘45内的空气，避免将空气带入患者体内引发空气栓塞。注液阀452可以选用现有技术中的三通阀，对此不作赘述。
综上，本申请提供的医用介入系统1及医用辅件60中，医用辅件60包括第一元件61及与其可拆卸连接的第二元件62。当第一元件61单独使用时，第一元件61可以用于保护和/或装载医用植入件20。当第一元件61和第二元件62装配成一个整体组合使用时，医用辅件60可以用于排除医用植入件20所在的医用介入系统1内的空气。因此，医用介入系统1不需要为医用植入件20的保护、装载以及整个系统的排气分别配置相应的单独部件，使得医用介入系统1的整体结构简单，操作方便，有利于减少手术时间。
需要说明的是，在本申请中，除第一密封体617、第二密封体627、第一通闭阀612及第二通闭阀622外，第一元件61与第二元件62的其它部件优选由透光性能优良的材质通过机加成型或注塑成型或挤出成型的方式获得。其中，透光性能优良的材质可以是但不限于聚甲基丙烯酸甲酯、聚苯乙烯、聚碳酸脂、苯乙烯-甲基丙烯酸甲酯共聚物树脂等材料中的一种或至少两种的混合物。第一元件61与第二元件62的不同部件可以选用相同材质，也可以分别选用不同的材质。
优选地，在一些实施方式中，上述的第一元件61与第二元件62的其它部件采用具有高度透明性的聚碳酸酯材质，并通过挤出成型方法获得。如图2及图5所示，由于第一元件61与第二元件62的其它部件具有高度透明性，第一元件61套接于调弯鞘41的远端上，且医用植入件20容置于管体613内时，操作者可以清晰地看到医用植入件20在管体613中的具体位置。不难理解，当医用植入件20没在管体613的安全有效位置时，操作者可以直接通过肉眼观察并把医用植入件20调整到管体613中的安全有效位置。其中，需要说明的是，对于管体613而言，除了管体613在两端的一定长度(例如10％)外，管体613中间的部分均能有效保护医用植入件20，即管体613的安全有效位置是指管体613的中间位置(例如是管体613两端之间的占据轴向长度约80％的位置)。为了使瓣膜夹、血管支架等常见的医用植入件20均可以容置于管体613内的安全有效位置，且保证管体613具有一定的强度，管体613的壁厚范围为0.3mm-1.5mm，长度范围为30mm-100mm。
在本申请中，第一密封体617和第二密封体627可以采用但不限于丁腈橡胶、热塑性聚氨酯、硅胶、聚四氟乙烯、尼龙弹性体等弹性材料并通过注塑成型的方式获得。优选地，在一些实施方式中，第一密封体617和第二密封体627采用硅胶制成，第一密封体617和第二密封体627的硬度范围为30A-60A。
请结合图11至图14，在一些实施方式中，第一筒体611可包括自近端至远端依次连接的螺接段6112、过渡段6114和插接段6116。螺接段6112用于连接第一帽体615以及容置第一密封体617，插接段6116用于连接管体613，过渡段6114用于供医用植入件20过渡穿入管体613中。
具体地，如图12至图14所示，螺接段6112自近端至远端的外径一致，其外周壁设有外螺纹。第一帽体615为环状的螺帽，其至少在远端内壁设置对应螺接段6112的外螺纹的内螺纹，第一帽体615通过螺纹连接的方式可拆卸连接于螺接段6112的外部。螺接段6112的内腔用于容置第一密封体617(见图13)。
如图12至图14所示，插接段6116自近端至远端的外径一致，并且小于螺接段6112的外径。插接段6116的内腔用于插接管体613的近端。可选地，如图13所示，在一些实施方式中，插接段6116的内径略大于管体613的外径，使得管体613的近端插入插接段6116的内腔后，管体613的外壁与插接段6116的内壁之间具有间隙，通过向该间隙内注入胶水，可以使管体613与插接段6116粘接固定，从而将管体613的近端密封连接于第一筒体611的远端。例如，在一种可能的实施方式中，管体613的外径比插接段6116的内径小0.5mm-1.5mm， 目的是为了管体613和第一筒体611插接时有足够的注胶空间，保证管体613和第一筒体611粘接的牢固性及二者之间的密封性。不难理解，管体613与插接段6116之间应具有足够粘接长度(例如可以是0.6mm-2.0mm)，以保证管体613与插接段6116的粘接可靠性。其中，胶水可以采用瞬干胶、医用胶或者UV胶等。需要说明的是，管体613的外形轮廓与插接段6116的内腔轮廓适配，管体613可以是但不限于圆形管、矩形管、多边形管，管体613的内腔的截面形状可以但不限于是圆形、矩形、多边形，对此不作限定。在本申请的实施方式中，管体613为具有圆形截面内腔的圆形管。
在其他的一些实施方式中，管体613的近端可以通过螺纹连接或者卡合连接等方式密封连接于第一筒体611的远端。在其他的另一些实施方式中，管体613也可以与第一筒体611一体成型。
进一步地，请结合图5、图6及图13所示，在一些实施方式中，插接段6116的外壁设置有外螺纹，第二帽体625的近端内腔对应设置有内螺纹，第二帽体625通过螺纹连接的方式套设于插接段6116上，实现第一筒体611的远端与第二帽体625的近端的可拆卸连接。优选的，插接段6116与第二帽体625之间通过双线螺纹连接，螺纹的圈数可以是1-3圈。和单线相同螺距的螺纹相比，插接段6116与第二帽体625采用双线螺纹，二者相对转动一圈的行程是单线螺纹行程的两倍，且螺纹强度是单线螺纹的两倍，更便于快捷操作、减少操作时间以及提高连接强度。
在其他实施方式中，第一筒体611的远端与第二帽体625的近端还可以通过其他的方式实现可拆卸连接，例如卡合连接。具体地，在一种可能的实施方式中，第一筒体611的插接段6116的外壁沿周向间隔设置有至少两个卡扣(优选关于第一筒体611的中心轴线对称分布)，第二帽体625的近端内壁对应插接段6116上的至少两个卡扣开设有至少两个卡槽，每一卡槽包括沿第二帽体625的轴向延伸的导引部及与导引部连通并沿第二帽体625的周向延伸的止位部，其中，止位部的槽宽比卡扣的宽度略大(例如大0.05mm-0.10mm)。使用过程中，插接段6116上的每一卡扣沿着对应的卡槽的导引部缓慢推进，当卡扣推送到卡槽的导引部底部时，旋转第一筒体611，使得卡扣的边缘到达卡槽的止位部的边缘，第一筒体611不能继续旋转为止，这样，通过卡槽的止位部对卡扣的限位作用，第一筒体611和第二帽体625不会发生轴向移动，且卡槽的宽度和卡扣的配合的间隙较小(只有0.05mm-0.10mm)，第一筒体611和第二帽体625在不受到外力的情况下不易发生相对转动，从而实现第一筒体611的远端与第二帽体625之间的可拆卸连接。
如图12至图14所示，过渡段6114连接于螺接段6112和插接段6116之间，过渡段6114的内腔用于供穿过螺接段6112内的第一密封体617的医用植入件20过渡穿入插接段6116并进一步进入管体613。优选地，在图13至图14所示的实施方式中，过渡段6114自近端至远端的内径逐渐减小至等于或者略小于管体613的直径，过渡段6114可以起到承接及引导的作用，使得医用植入件20顺畅进入管体613内。
如图12所示，在一些实施方式中，第一筒体611还包括用于连接第一通闭阀612的第一短管6118，第一短管6118径向凸设于过渡段6114的外周壁且与过渡段6114的内腔连通。第一短管6118沿垂直于第一筒体611的中心轴线的方向延伸，并通过第一连接管(图中未标号)与第一通闭阀612进行连通。第一连接管可以采用但不限于聚四氟乙烯、热塑性聚氨酯等材质制成，并通过医用胶、瞬干胶或者UV胶把第一短管6118和第一连接管粘接为一体。其中，第一连接管的长度适中，通常为4mm-10mm。
在其他的一些实施方式中，第一通闭阀612可以直接连接于第一筒体611的第一短管 6118，从而不需要设置第一连接管。在其他的另一些实施方式中，第一筒体611也可以不设置第一短管6118，而直接在过渡段6114的外周壁开设端口，第一通闭阀612通过第一连接管连接于过渡段6114上的端口或者第一通闭阀612直接连接于过渡段6114上的端口，从而连通第一筒体611的内腔，对此不作限定。
如前所述，在一些实施方式中，第一密封体617设置于螺接段6112的内腔中。具体地，如图12至图15所示，第一密封体617为环状的弹性密封体，其近端部分设有为锥孔形的第一内孔6172，其远端部分设有连通过渡段6114的内腔和第一内孔6172的凹槽。需要说明的是，自然状态下的第一密封体617自近端至远端的外径一致并且大于螺接段6112的内径，第一密封体617可被弹性挤压于螺接段6112的内腔中，使得螺接段6112与第一密封体617的整个外周壁挤压接触，以实现第一密封体617与第一筒体611之间的密封。
优选地，在图12至图15所示的实施方式中，第一筒体611的近端内壁(即螺接段6112的内壁)设有止挡部6119，止挡部6119具体为形成于螺接段6112与过渡段6114连接处的台阶(即螺接段6112的内径至少大于过渡段6114连接螺接段6112的部分的内径)，第一帽体615上设有抵顶部6159，抵顶部6159包括连接于第一帽体615的近端且沿第一帽体615的径向向内延伸的连接段(图中未标号)、及连接于连接段靠近第一帽体615的中轴线一侧的且沿第一帽体615的轴向向远端延伸的抵顶段(图中未标号)，抵顶段与第一帽体615的近端内壁之间具有径向间隙。如图13及图15所示，当第一密封体617收容于第一筒体611的近端的内腔(即螺接段6112的内腔)中且第一帽体615连接于第一筒体611的近端时，螺接段6112的近端部分位于抵顶部6159的抵顶段与第一帽体615内壁之间的间隙内，第一密封体617位于止挡部6119与抵顶部6159之间。可以理解的是，在图13及图15所示的实施方式中，第一帽体615相对于第一筒体611旋转的同时可相对第一筒体611沿轴向向远端移动，以使抵顶部6159的抵顶段在轴向上挤压第一密封体617的近端，由于第一密封体617的外周壁被第一筒体611的螺接段6112的内壁束缚，并且第一密封体617的远端被止挡部6119抵顶，第一密封体617在轴向上被挤压的同时会在径向上向第一内孔6172的中轴线方向发生形变，进而使得第一内孔6172的内径减小。需要说明的是，螺接段6112的近端部分位于抵顶部6159的抵顶段与第一帽体615内壁之间的间隙内时，螺接段6112的近端与抵顶部6159的连接段之间具有足够长的轴向间距，以使抵顶部6159能够在轴向上向远端移动足够长的距离，进而使得抵顶部6159的抵顶段能够对第一密封体617产生足够的轴向挤压量(例如0.5mm-2.5mm)，从而保证第一密封体617在径向上与调弯鞘41之间具有足够的过盈挤压量(例如第一密封体617的单边挤压量为0.5mm-1mm)，确保第一内孔6172的孔径可以减小至抱紧穿过第一内孔6172的调弯鞘41的远端。不难理解，当第一帽体615相对于第一筒体611反向旋转以使得第一帽体615相对第一筒体611沿轴向逐渐向近端移动的过程中，抵顶段对第一密封体617的轴向挤压量逐渐减小，第一密封体617在径向上的形变量随之逐渐减小，使得第一内孔6172的孔径逐渐增大，直至第一内孔6172的孔径增大至不与调弯鞘41接触，第一密封体617即不再抱紧调弯鞘41。
请结合图16，在其他的实施方式中，第一密封体617自近端至远端的外径可不一致，第一密封体617由远端呈圆环结构的固定部(图中未标号)和近端呈锥台结构的挤压部(图中未标号)组成。自然状态下的固定部的外径一致且大于螺接段6112的内径，挤压部自近端至远端的外径逐渐增大。固定部被弹性挤压于螺接段6112的内腔中，使得螺接段6112与第一密封体617的固定部的外周壁挤压接触以形成密封。第一密封体617的挤压部的外周壁具有第一锥面6177，第一锥面6177与第一密封体617的轴线之间的径向距离自第一锥面6177的 近端至第一锥面6177的远端逐渐增大，第一帽体615的抵顶部6159具有与第一锥面6177相对且适配的第二锥面6157。其中，第一锥面6177和第二锥面6157的锥度可以一致，即第一锥面6177和第二锥面6157平行，并且第二锥面6157的最小径向尺寸(即抵顶部6159近端的内径)小于第一锥面6177的最小径向尺寸(即第一密封体617近端的外径)。可以理解的是，在图16所示的实施方式中，第一帽体615相对于第一筒体611旋转的同时可相对第一筒体611轴向向远端移动，以使抵顶部6159的第二锥面6157逐渐挤压第一密封体617的第一锥面6177，由于第一锥面6177和第二锥面6157为互相平行的锥面，抵顶部6159会对第一密封体617施加一个垂直于第一锥面6177的挤压力，在该挤压力的作用下，抵顶部6159同时在轴向和径向上挤压第一密封体617的挤压部，使得第一密封体617同时在轴向和径向上发生形变，进而使得第一内孔6172的孔径变小，从而能够使第一密封体617抱紧穿过第一内孔6172的调弯鞘41，实现密封的作用。
在上述实施方式中，第一帽体615相对第一筒体611旋转的同时可相对第一筒体611轴向移动，进而在轴向上和/或径向上挤压第一密封体617，以使得第一内孔6172的孔径减小，从而实现第一密封体617与调弯鞘41之间的抱紧和密封。
在其他实施方式中，第一帽体615可以被设置为相对于第一筒体611旋转或者相对于第一筒体611轴向移动，从而在轴向上和/或径向上挤压第一密封体617，同样可以实现第一密封体617与调弯鞘41之间的抱紧和密封，对此不作赘述。
也即是说，在本申请中，可拆卸连接于第一筒体611近端的第一帽体615可以被设置为相对第一筒体611旋转和/或轴向移动，并在轴向上和/或径向上挤压第一筒体611内的第一密封体617，从而使第一内孔6172的孔径减小，以实现第一密封体617与调弯鞘41之间的抱紧和密封。
请再次参阅图1至图3，在本申请中，在医用介入系统1处于第一状态时，即医用介入系统1的包装、灭菌、运输等过程中，第一元件61未连接第二元件62，第一元件61套接于调弯鞘41的远端(具体为调弯鞘管414的远端)。具体地，如图1至图3所示，输送鞘43的远端(具体为输送鞘管434的远端)可拆卸连接医用植入件20且医用植入件20外露出调弯鞘管414的远端后，操作者需要把医用植入件20回撤到第一元件61的管体613的内腔中，在医用植入件20进入到管体613内的安全有效位置之前，螺帽结构的第一帽体615处于初始的非拧紧状态，即第一帽体615未相对第一筒体611旋转，此时，第一密封体617轴向没受到挤压力，第一密封体617的第一内孔6172未发生变化，第一密封体617未抱紧调弯鞘管414，第一元件61能无阻力在调弯鞘管414上移动。缓慢移动第一元件61，使得医用植入件20回撤到管体613中的安全有效位置后，控制第一帽体615相对第一筒体611旋转以使第一帽体615相对第一筒体611沿轴向向远端移动，第一帽体615挤压第一密封体617而使第一内孔6172的孔径减小，使得第一密封体617抱紧调弯鞘管414，从而把第一元件61固定在调弯鞘管414远端上，医用植入件20容纳于管体613的安全有效位置内，管体613能有效地保护医用植入件20在手术前的所有环节中不受到损伤。
请结合图5至图7、图17以及图18，在一些实施方式中，第二筒体621为具有圆形截面内腔的中空管体，其内径要比管体613的外径大(例如大0.5mm-3.5mm)，以便于管体613穿插入第二筒体621的内腔。第二筒体621的轴向长度比管体613外露于第一筒体611的部分的轴向长度长(例如长3mm-15mm)，以便于管体613外露于第一筒体611的部分能够完全容纳于第二筒体621的内腔中。如图6所示，第二筒体621的远端端部设有连通其内腔的第二短管(图中未标号)，第二短管通过第二连接管(图中未标号)与第二通闭阀622进行连通。 在其他实施方式中，类似于第一通闭阀612，第二通闭阀622也可以直接连接于第二筒体621的远端或者其他合理位置，从而不需要设置第二连接管；第二筒体621也可以不设置第二短管，并直接在其远端端部或者其他合理位置开设连接端口，第二通闭阀622通过第二连接管连接于该端口或者第二通闭阀622直接连接于该端口，从而连通第二筒体621的内腔，对此不作限定。
在图5至图7、图17以及图18所示的实施方式中，第二密封体627可以为环状的弹性密封体，第二密封体627设置于第二筒体621的近端内腔中。其中，自然状态下的第二密封体627自近端至远端的外径一致并且大于第二筒体621的近端内腔的内径，第二密封体627能够被弹性挤压于第二筒体621的近端内腔中，使得第二筒体621与第二密封体627的外周壁挤压接触以形成密封。再者，第二密封体627的第二内孔6272的孔径比管体613的外径小，例如可以小1mm-3mm。通过将第二内孔6272的孔径与管体613的外径之差设计为合理数值范围(如前述的1mm-3mm)内，可以使管体613进入第二筒体621的阻力不会过大，且管体613插入第二筒体621内并穿过第二内孔6272时，管体613与第二密封体627之间为过盈配合，从而能够保证第二密封体627对管体613具有良好的密封效果。
优选地，如图6及图7所示，在一些实施方式中，第二筒体621的近端内壁开设有环状避让槽，环状避让槽沿第二筒体621轴向上的槽底开设有一圈止挡台阶，第二密封体627设置于第二筒体621内时，止挡台阶抵顶第二密封体627的远端，从而防止第二密封体627沿轴向向远端移动。进一步地，在图6及图7所示的实施方式中，第二帽体625包括位于近端的螺帽以及连接于螺帽远端的插管，第二帽体625连接于第二筒体621的近端时，插管的远端收容于第二筒体621近端的环状避让槽内，且插管的远端抵顶第二密封体627的近端，从而防止第二密封体627沿轴向向近端移动。第二密封体627的相对两端分别被第二筒体621的止挡台阶和第二帽体625的插管抵顶，限制了第二密封体627沿轴向的移动，有利于提高第二密封体627设置于第二筒体621内的稳固性，进而保证第二密封体627与管体613之间的密封可靠性。
其中，如图6及图7所示，在一些实施方式中，第二筒体621的环状避让槽的内径大于第二帽体625的插管的外径，环状避让槽的周向侧壁与插管的外周壁之间具有间隙，通过向间隙内注入胶水，使第二筒体621与第二帽体625粘接为一体，从而将第二帽体625连接于第二筒体621的近端。优选地，第二密封体627也可以通过胶水与第二筒体621和/或第二帽体625粘接于一体，可提高第二密封体627的稳固性。其中，胶水可以采用瞬干胶、医用胶或者UV胶等。进一步优选地，插管的远端外周壁开设环状收容槽，第二密封体627的近端设有环状舌边，插管的远端抵顶第二密封体627的近端时，环状舌边搭接于插管的远端外周壁并收容于环状收容槽内，如此，增大了第二密封体627与第二帽体625的胶接面积，有利于提高第二密封体627与第二帽体625的粘接可靠性。
在其他实施方式中，环状避让槽的周向侧壁可以设置内螺纹，插管的外周壁对应设置外螺纹，第二帽体625可以通过螺纹连接的方式连接于第二筒体621的近端，优选通过双线螺纹连接，螺纹连接方便拆卸，拆装速度更快。
可以理解的是，在其他实施方式中，第二密封体627还可以通过粘接等方式设置于第二帽体625的插管内，同样可以实现第二密封体627与穿过第二内孔6272的管体613之间的密封，对此不作赘述。
如前所述，在一些实施方式中，第一元件61与第二元件62组合作用时，通过第一通闭阀612、第二通闭阀622、第一排气阀412及第二排气阀432的配合使用可以在术前排除医用 介入系统1内的空气，以避免医用介入系统1内的空气进入血管内造成空气栓塞。
具体地，请结合图4、图5及图19，本申请还提供一种医用介入系统1的排气方法，其包括步骤S1及S2，详细介绍如下。
步骤S1：如图4及图5所示，将第一元件61套接于调弯鞘41的远端(具体为调弯鞘管414的远端)上并连接第二元件62，使调弯鞘41的远端穿过第一内孔6172且被第一密封体617抱紧，医用植入件20容置于管体613的内腔中。其中，如图4及图5所示，第一元件61可拆卸连接第二元件62时，管体613伸入第二筒体621的内腔中，可拆卸连接于输送鞘43远端(具体为输送鞘管434的远端)的医用植入件20也即和管体613位于第二筒体621内，并且管体613与第二筒体621的内腔之间形成密封，使得第二筒体621的内腔(即第二元件62的内腔)、第一筒体611的内腔(即第一元件61的内腔)、调弯鞘41的内腔以及输送鞘43的内腔密封连通。
步骤S2：保持密封连接第二元件62内腔的第二通闭阀622、密封连接调弯鞘41内腔的第一排气阀412及密封连接输送鞘43内腔的第二排气阀432中的任意两者关闭，剩余的一者与密封连接第一元件61内腔的第一通闭阀612一起打开，向第一通闭阀612注入液体(不限于生理盐水)，直至液体从所述剩余的一者流出。需要说明的是，在一些实施方式中，操作者依次将第一通闭阀612与第二通闭阀622、第一排气阀412及第二排气阀432一起打开，以分别作为液体的注入阀和流出阀，即可依次排出医用辅件60、调弯鞘41和输送鞘43内的空气。
更具体地，请结合图20至图22，在一些实施方式中，医用介入系统1的排气方法中的步骤S2依序包括以下几个排气操作。
第一步，如图20所示的A1-A2的排气路径，在第一通闭阀612、第二通闭阀622、第一排气阀412及第二排气阀432均关闭状态下，将第二通闭阀622置于最高位置(重力方向上的最高位置)，打开第一通闭阀612和第二通闭阀622，并向第一通闭阀612注入液体，直至液体从第二通闭阀622流出，以排出医用辅件60内的空气，也即排除第一元件61和第二元件62内的空气。
其中，需要说明的是，在进行第一步前，操作者需要控制第一帽体615相对第一筒体611转动以旋紧第一帽体615，使第一帽体615挤压第一筒体611内的第一密封体617，进而使第一内孔6172的孔径减小，保证第一密封体617抱紧调弯鞘41的远端，同时第二密封体627密封管体613的外周。此外，当液体自第二通闭阀622流出后，操作者需要先关闭第二通闭阀622再关闭第一通闭阀612，确认第一通闭阀612关闭后才可以停止注入液体，如此可以避免空气带入医用辅件60的内腔中。
可以理解的是，由于医用辅件60除第一密封体617和第二密封体627之外的其他部件均采用透光性能优良的材质制成，在完成第一步的排气操作之后，操作者可以观察用于容置医用植入件20的管体613内是否还有残留空气，如果管体613的内腔表面还附着有气泡，可以通过轻弹第一筒体611与管体613，使气泡汇集在一起，并重复第一步的排气操作，直至第二通闭阀622有液体流出且无气泡出现，确保医用辅件60的内腔空气被排净。
第二步，如图21所示的B1-B2的排气路径，完成第一步的排气操作后，在第一通闭阀612、第二通闭阀622、第一排气阀412及第二排气阀432均关闭状态下，将第一排气阀412置于最高位置，打开第一通闭阀612和第一排气阀412，并向第一通闭阀612注入液体，直至液体从第一排气阀412流出，以排出调弯鞘41内的空气。其中，当液体自第一排气阀412流出后，操作者需要先关闭第一排气阀412再关闭第一通闭阀612，确认第一通闭阀612关 闭后才可以停止注入液体，如此可以避免空气带入调弯鞘41的内腔中。
一般来说，调弯手柄416也会设置透明部件，因此，在完成第二步的排气操作之后，操作者可以通过调弯手柄416的透明部件观察调弯手柄416的内腔是否还有残留气泡，如果调弯手柄416的内腔表面还附着有气泡，可以通过轻弹调弯手柄416的外壳，使气泡汇集在一起，并重复第二步的排气操作，直至第一排气阀412有液体流出且无气泡出现，从而确保调弯鞘41的内腔空气被排净。
第三步，如图22所示的C1-C2的排气路径，完成第二步的排气操作后，在第一通闭阀612、第二通闭阀622、第一排气阀412及第二排气阀432均关闭状态下，将第二排气阀432置于最高位置，打开第一通闭阀612和第二排气阀432，并向第一通闭阀612注入液体，直至液体从第二排气阀432流出，以排出输送鞘43内的空气。其中，当液体自第二排气阀432流出后，操作者需要先关闭第二排气阀432再关闭第一通闭阀612，确认第一通闭阀612关闭后才可以停止注入液体，如此可以避免空气带入输送鞘43的内腔中。
如图22所示，输送手柄436上通常会设置由透明材料制成的观察窗口4361，在完成第三步的排气操作之后，操作者可以通过观察窗口4361观察输送手柄436的内腔是否还有残留气泡，如果输送手柄436的内腔表面还附着有气泡，通过轻弹输送手柄436的外壳，使气泡汇集在一起，并重复第三步的排气操作，直至第二排气阀432有液体流出且无气泡出现，从而确保输送鞘43的内腔空气被排净。
完成上述排气过程后，操作者可以观察医用辅件60、调弯手柄416、输送手柄436内是否有残留气泡，如还有残留气泡，需重复上述三步排气操作，直至医用介入系统1的内腔空气被排净。
可以理解的是，在其他的实施方式中，当第一密封体617抱紧调弯鞘41的远端时，医用介入系统1的排气方法中的步骤S2也可以按照其他的顺序排出医用辅件60、调弯鞘41和输送鞘43内的空气，例如可以先排出调弯鞘41内的空气、再排出输送鞘43内的空气、最后排出医用辅件60内的空气，只要可通过重复几个排气操作以确保医用介入系统1的内腔空气被排净即可，对此不作限定。
进一步地，请再次结合图8至图10，如前所述，在一些实施方式中，当医用介入系统1完成排气之后，操作者可解除第一元件61与第二元件62的连接并取下第二元件62，然后将导引鞘45与第一元件61进行套接，以使医用植入件20装载入导引鞘45内，操作者通过输送装置40的导引鞘45建立的介入通道即可将医用植入件20推送至预定治疗位点。
具体地，如图8至图10所示，导引鞘45与第一元件61进行套接时，管体613的远端穿插入导引鞘45的近端内腔中，容置于管体613内的医用植入件20也即进入导引鞘45的近端内腔。其中，如图9及图10所示，在一些实施方式中，导引鞘45内设有密封垫片451及过渡件453。密封垫片451由弹性材料(例如是但不限于硅胶)制成，并开设有切口(可以是但不限于十字形切口或者圆形切口)，密封垫片451用于供管体613穿过并密封管体613的外周，从而实现管体613与导引鞘45之间的密封连接。过渡件453设于密封垫片451的远端侧，用于抵触管体613的远端，从而起到限位的作用。优选地，如图10所示，过渡件453开设有锥孔，锥孔自近端至远端的直径逐渐减小，且锥孔的最小直径小于管体613的外径，管体613的远端自锥孔近端伸入过渡件453并抵顶于过渡件453的内壁。管体613可以方便地通过锥孔伸入过渡件453，并且可以与过渡件453之间实现缓冲性接触，从而避免硬接触，有利于保护管体613。
如图8至图10所示，当通过导引鞘45建立介入通道后，将完成排气的医用介入系统1 中的第二元件62自第一元件61的远端取下，把容置有医用植入件20的管体613穿过密封垫片451的切口位置，继续把第一元件61往前推送，直到管体613的远端到达导引鞘45内的过渡件453的位置，此时，第一元件61为医用植入件20进入导引鞘45内腔建立了一个安全通道，此后可略旋松第一元件61的第一帽体615，以适当减小第一密封体617对调弯鞘管414的抱紧力，使得在保持密封的前提下，调弯鞘管414能够相对第一密封体617运动，医用植入件20被调弯鞘41及输送鞘43带动并顺利进入导引鞘45内腔，之后沿着第一元件61和导引鞘45建立的通道，通过输送鞘43及调弯鞘41将医用植入件20顺利输送至患者体内的指定位置(例如左心房)，然后再通过操控各个手柄，把医用植入件20释放并留置于患者体内，从而完成相应的介入手术(例如二尖瓣缘对缘修复术)。
需要说明的是，在医用植入件20进入导引鞘45内以及到达患者体内指定位置的过程中，可能会带入少量空气进入各鞘管内，可通过在第一通闭阀612上连接一个负压装置(不限于注射器)，对各鞘管内施加一个负压，即可将各鞘管内的多余空气抽出。此外，第一筒体611内腔和导引鞘45内腔相通，导引鞘45远端位置在患者体内指定位置(如左心房、主动脉)内，可通过在第一通闭阀612上连接相应的监测设备(不限于血压监测设备)，即可在手术过程中监测患者的生理参数，例如血管内血压或者是心脏的心房室压差，并根据患者的生理参数判断医用植入件20的植入效果。
需要说明的是，和现有的导引鞘类似，导引鞘45还具有其他的部件，例如可拆卸连接(例如是但不限于螺纹连接)于导引手柄456近端的端盖458(见图10)、以及设于密封垫片451和过渡件453之间的O型密封圈等，其中，端盖458开设有供管体613穿过的通孔，在此不作赘述。
综上，本申请提供的医用辅件60、医用介入系统1及其排气方法中，医用辅件60包括第一元件61及与其可拆卸连接的第二元件62。当第一元件61单独使用时，第一元件61可以用于保护和/或装载医用植入件20。当第一元件61和第二元件62装配成一个整体组合使用时，医用辅件60可以用于排除医用植入件20所在的医用介入系统1内的空气。因此，医用介入系统1不需要为医用植入件20的保护、装载以及整个系统的排气分别配置相应的单独部件，使得医用介入系统1的整体结构简单，操作方便，有利于减少手术时间。
在本说明书的描述中，参考术语“一些实施方式”、“示意性实施方式”、“示例”、“具体示例”、或“一些示例”等的描述意指结合该实施方式或示例描述的具体特征、结构、材料或者特点包含于本申请的至少一个实施方式或示例中。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方式或示例。而且，描述的具体特征、结构、材料或者特点可以在任何的一个或多个实施方式或示例中以合适的方式结合。
尽管已经示出和描述了本申请的实施方式，本领域的普通技术人员可以理解：在不脱离本申请的原理和宗旨的情况下可以对这些实施方式进行多种变化、修改、替换和变型，本申请的范围由权利要求及其等同物限定。

Claims (16)

  1. 一种医用辅件，其特征在于，包括第一元件及第二元件；
    所述第一元件包括第一筒体、密封连接所述第一筒体远端的管体、可拆卸连接所述第一筒体近端的第一帽体、设于所述第一筒体内的第一密封体以及密封连接所述第一筒体的内腔的第一通闭阀；其中，所述第一密封体具有第一内孔，所述第一帽体可选择性地挤压所述第一密封体，以使得所述第一内孔的孔径减小；
    所述第二元件包括第二筒体及密封连接所述第二筒体的内腔的第二通闭阀；
    所述第一筒体的远端与所述第二筒体的近端可拆卸连接，在连接状态下，所述管体伸入所述第二筒体的内腔中，且所述管体与所述第二筒体的内腔之间形成密封。
  2. 如权利要求1所述的医用辅件，其特征在于，所述第一元件单独使用时，所述管体的内腔套设于医用植入件外，以保护和/或装载所述医用植入件。
  3. 如权利要求2所述的医用辅件，其特征在于，所述管体的内腔容置有所述医用植入件，且所述第一筒体的远端与所述第二筒体连接后，所述第一元件和所述第二元件组合使用，以用于排除所述医用植入件所在的医用介入系统内的空气。
  4. 如权利要求2所述的医用辅件，其特征在于，所述第一筒体的内腔的最小内径大于所述医用植入件的最大外径，且小于或者等于所述管体的内径。
  5. 如权利要求1所述的医用辅件，其特征在于，所述第一帽体可相对所述第一筒体旋转和/或轴向移动，并在轴向上和/或径向上挤压所述第一密封体。
  6. 如权利要求5所述的医用辅件，其特征在于，所述第一筒体的近端内壁上设有止挡部，所述第一帽体上设有抵顶部；所述第一密封体收容于所述第一筒体的近端的内腔中，且位于所述止挡部与所述抵顶部之间。
  7. 如权利要求6所述的医用辅件，其特征在于，所述第一内孔为锥孔，所述锥孔的内径自其近端至其远端逐渐减小。
  8. 如权利要求6所述的医用辅件，其特征在于，所述第一密封体的外周壁具有第一锥面，所述第一锥面与所述第一密封体的轴线之间的径向距离自所述第一锥面的近端至所述第一锥面的远端逐渐增大，所述抵顶部具有与所述第一锥面相对且适配的第二锥面。
  9. 如权利要求1-8任一项所述的医用辅件，其特征在于，所述第二元件还包括第二帽体及设于所述第二筒体或者所述第二帽体内的第二密封体，所述第二帽体连接所述第二筒体的近端，所述第二密封体具有第二内孔；
    所述第一筒体的远端与所述第二帽体的近端可拆卸连接，连接状态下，所述管体的远端穿过所述第二内孔并与所述第二密封体过盈配合，使得所述管体与所述第二筒体的内腔之间形成密封。
  10. 如权利要求9所述的医用辅件，其特征在于，所述第一筒体的远端通过螺纹连接或者卡合连接的方式可拆卸连接于所述第二帽体的近端。
  11. 一种医用介入系统，其特征在于，包括医用植入件、输送装置及如权利要求1-10任一项所述的医用辅件；
    所述输送装置包括调弯鞘与输送鞘，所述输送鞘活动穿设于所述调弯鞘内，所述输送鞘的远端可拆卸连接所述医用植入件；其中，所述调弯鞘上设有第一排气阀，所述输送鞘上设有第二排气阀；
    第一状态下，所述第一元件套接于所述调弯鞘的远端上，所述调弯鞘的远端穿过所述第 一内孔且被所述第一密封体抱紧，所述医用植入件容置于所述管体的内腔中，所述第一元件单独作用，以保护所述医用植入件；
    第二状态下，所述第一元件套接于所述调弯鞘的远端上并连接所述第二元件，所述调弯鞘的远端穿过所述第一内孔且被所述第一密封体抱紧，所述医用植入件容置于所述管体的内腔中；所述第一元件与所述第二元件组合作用，以通过所述第一通闭阀、所述第二通闭阀、所述第一排气阀及所述第二排气阀排除所述医用介入系统内的空气。
  12. 如权利要求11所述的医用介入系统，其特征在于，所述输送装置还包括导引鞘；
    第三状态下，所述第一元件套接于所述调弯鞘的远端上，所述调弯鞘的远端穿过所述第一内孔且被所述第一密封体抱紧，所述医用植入件容置于所述管体的内腔中；
    所述第一元件单独作用，所述管体穿插入所述导引鞘内，使得所述医用植入件装载入所述导引鞘。
  13. 如权利要求12所述的医用介入系统，其特征在于，自然状态下，所述第一内孔的孔径等于或者大于所述调弯鞘的远端的外径；所述管体的内径大于所述调弯鞘的外径。
  14. 如权利要求12所述的医用介入系统，其特征在于，所述导引鞘内设有密封垫片及过渡件，所述密封垫片供所述管体穿过并密封所述管体的外周，所述过渡件设于所述密封垫片的远端侧，用于抵触所述管体的远端。
  15. 如权利要求11-14任一项所述的医用介入系统的排气方法，其特征在于，至少包括以下操作：
    将所述第一元件套接于所述调弯鞘的远端上并连接所述第二元件，使所述调弯鞘的远端穿过所述第一内孔且被所述第一密封体抱紧，所述医用植入件容置于所述管体的内腔中；
    保持所述第二通闭阀、所述第一排气阀及所述第二排气阀中的任意两者关闭，剩余的一者与所述第一通闭阀一起打开，向所述第一通闭阀注入液体，直至所述液体从所述剩余的一者流出。
  16. 如权利要求15所述的医用介入系统的排气方法，其特征在于，包括：
    在所述第一通闭阀、所述第二通闭阀、所述第一排气阀及所述第二排气阀均关闭状态下，将所述第二通闭阀置于最高位置，打开所述第一通闭阀和所述第二通闭阀，并向所述第一通闭阀注入液体，直至所述液体从所述第二通闭阀流出，以排出所述医用辅件内的空气；
    在所述第一通闭阀、所述第二通闭阀、所述第一排气阀及所述第二排气阀均关闭状态下，将所述第一排气阀置于最高位置，打开所述第一通闭阀和所述第一排气阀，并向所述第一通闭阀注入液体，直至液体从所述第一排气阀流出，以排出所述调弯鞘内的空气；以及
    在所述第一通闭阀、所述第二通闭阀、所述第一排气阀及所述第二排气阀均关闭状态下，将所述第二排气阀置于最高位置，打开所述第一通闭阀和所述第二排气阀，并向所述第一通闭阀注入液体，直至液体从所述第二排气阀流出，以排出所述输送鞘内的空气。
PCT/CN2022/117616 2021-12-31 2022-09-07 医用辅件、医用介入系统及其排气方法 WO2023124212A1 (zh)

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CN204500900U (zh) * 2015-02-28 2015-07-29 杨房 一种新型先天性心脏病介入治疗的外科输送装置
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Publication number Priority date Publication date Assignee Title
US20090287182A1 (en) * 2008-05-14 2009-11-19 Onset Medical Corporation Expandable iliac sheath and method of use
CN204500900U (zh) * 2015-02-28 2015-07-29 杨房 一种新型先天性心脏病介入治疗的外科输送装置
US20210196929A1 (en) * 2018-09-06 2021-07-01 Harmony Medical Limited Introducer sheath
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