Medical accessory, medical interventional system and method for venting thereof

Abstract

The application provides a medical accessory, a medical intervention system and a method for evacuating the medical intervention system. The medical accessory comprises a first element and a second element. The first element comprises a first barrel, a tube body sealingly connected to a distal end of the first barrel, a first cap body detachably connected to a proximal end of the first barrel, a first sealing body arranged in the first barrel, and a first on-off valve sealingly connected to an inner cavity of the first barrel. The first sealing body has a first inner hole, and the first cap body can selectively extrude the first sealing body to reduce the aperture of the first inner hole. The second element comprises a second barrel and a second on-off valve sealingly connected to an inner cavity of the second barrel. A distal end of the first barrel is detachably connected to a proximal end of the second barrel. In the connected state, the tube body extends into the inner cavity of the second barrel, and a seal is formed between the tube body and the inner cavity of the second barrel. The first element can be used alone to protect and / or load a medical implant, and can also be used in combination with the second element to evacuate air in the medical intervention system in which the medical implant is located.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to a medical accessory, a medical intervention system and a method for venting exhaust. Background Technology

[0002] The mitral and tricuspid valves, among others, are one-way valves in the heart. Normal, healthy atrioventricular valves control the flow of blood from the atria to the ventricles, while preventing blood from flowing from the ventricles back to the atria. For example, the mitral valve, located between the left atrium and left ventricle, controls the flow of blood from the left atrium to the left ventricle, while preventing blood from flowing from the left ventricle back to the left atrium. The tricuspid valve, located between the right atrium and right ventricle, controls the flow of blood from the right atrium to the right ventricle, while preventing blood from flowing from the right ventricle back to the right atrium. The mitral valve consists of an anterior and posterior leaflets, while the tricuspid valve consists of an anterior leaflet, a posterior leaflet, and a septal leaflet. Under normal circumstances, when the left or right ventricle contracts, the edges of any two adjacent leaflets of the mitral or tricuspid valve completely align, preventing blood from flowing from the ventricle to the atrium. If the leaflets or related structures undergo organic or functional changes, such as partial rupture of the chordae tendineae, resulting in poor occlusion of adjacent leaflets of the mitral or tricuspid valve, the mitral or tricuspid valve cannot close completely when the left or right ventricle contracts, causing blood to flow back from the ventricle to the atrium, thus causing a series of pathophysiological changes, known as "mitral regurgitation" or "tricuspid regurgitation".

[0003] Many elderly patients with mitral or tricuspid regurgitation are not suitable for surgical repair. Interventional therapies emerged to address this, and after nearly 20 years of development, they are now widely used in the clinical treatment of heart disease, gradually becoming a focus of medical attention. In recent years, with the continuous development of interventional therapy, various medical devices have been used in the clinical treatment of mitral or tricuspid valve problems. Existing technologies have disclosed various implantable devices (valve clips) for clamping the mitral or tricuspid valves to perform edge-to-edge repair, effectively reducing or even eliminating regurgitation.

[0004] The implant needs to be placed at a predetermined site using a medical interventional system. During the transportation and preparation of the medical interventional system, the implant must be protected to prevent damage and malfunction. Before use, the entire system must be rigorously purged to prevent air from being introduced into the body and causing air embolism. Furthermore, the implant needs to be loaded during use.

[0005] However, in the existing technology, separate single-function independent components are usually configured for implant protection, system venting, and implant loading, resulting in a large number of components in the medical intervention system, which makes operation inconvenient and prolongs the operation time. Summary of the Invention

[0006] The purpose of this application is to provide a medical accessory, a medical interventional system, and a method for venting the same, wherein the medical accessory can be used to protect and / or load medical implants and to vent the medical interventional system.

[0007] To achieve the above objectives, in a first aspect, this application provides a medical accessory, including a first element and a second element. The first element includes a first cylindrical body, a tube sealingly connected to the distal end of the first cylindrical body, a first cap detachably connected to the proximal end of the first cylindrical body, a first sealing body disposed within the first cylindrical body, and a first on / off valve sealingly connected to the inner cavity of the first cylindrical body. The first sealing body has a first inner bore, and the first cap can selectively compress the first sealing body to reduce the diameter of the first inner bore. The second element includes a second cylindrical body and a second on / off valve sealingly connected to the inner cavity of the second cylindrical body. The distal end of the first cylindrical body is detachably connected to the proximal end of the second cylindrical body. In the connected state, the tube extends into the inner cavity of the second cylindrical body, and a seal is formed between the tube and the inner cavity of the second cylindrical body.

[0008] Secondly, this application provides a medical interventional system, including a medical implant, a delivery device, and medical accessories as described above. The delivery device includes a bending sheath and a delivery sheath, the delivery sheath being movably inserted within the bending sheath. The distal end of the delivery sheath is detachably connected to the medical implant. The bending sheath is provided with a first exhaust valve, and the delivery sheath is provided with a second exhaust valve. In a first state, the first element is sleeved on the distal end of the bending sheath, the distal end of the bending sheath passing through the first inner hole and being held tightly by the first sealing body. The medical implant is housed within the inner cavity of the tube body. The first element functions alone to protect the medical implant. In a second state, the first element is sleeved on the distal end of the bending sheath and connected to the second element. The distal end of the bending sheath passing through the first inner hole and being held tightly by the first sealing body. The medical implant is housed within the inner cavity of the tube body. The first element and the second element work together to expel air from the medical interventional system through the first on / off valve, the second on / off valve, the first exhaust valve, and the second exhaust valve.

[0009] Thirdly, this application also provides a method for venting the medical interventional system as described above, the method comprising at least the following operations: fitting the first element onto the distal end of the bending sheath and connecting the second element, such that the distal end of the bending sheath passes through the first inner hole and is held tightly by the first sealing body, the medical implant being housed in the inner cavity of the tube; keeping any two of the second on / off valve, the first venting valve, and the second venting valve closed, and opening the remaining one together with the first on / off valve, injecting liquid into the first on / off valve until the liquid flows out from the remaining one.

[0010] The medical accessory, medical intervention system, and venting method provided in this application include a first element and a second element detachably connected thereto. When the first element is used alone, it can be used to protect and / or load a medical implant. When the first element and the second element are assembled into a whole, the medical accessory can be used to vent air from the medical intervention system. Therefore, the medical intervention system does not need to be equipped with separate components for the protection and loading of the medical implant and the venting of the entire system, making the overall structure of the medical intervention system simple, easy to operate, and conducive to reducing surgical time. Attached Figure Description

[0011] To more clearly illustrate the technical solutions of the embodiments of this application, the drawings used in the embodiments will be briefly introduced below. Obviously, the drawings described below are some embodiments of this application. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0012] Figure 1 This is a schematic diagram of the structure of a medical interventional system provided in the first state according to an embodiment of this application.

[0013] Figure 2 yes Figure 1 An enlarged schematic diagram of part II in the diagram.

[0014] Figure 3 yes Figure 2 A cross-sectional view along the III-III direction.

[0015] Figure 4 yes Figure 1 A schematic diagram of the medical intervention system in the second state.

[0016] Figure 5 yes Figure 4 An enlarged schematic diagram of the V part in the diagram.

[0017] Figure 6 yes Figure 5 An axial sectional view of the second element in the diagram.

[0018] Figure 7 yes Figure 6 An enlarged schematic diagram of part VII in the diagram.

[0019] Figure 8 yes Figure 1 A schematic diagram of the medical intervention system in the third state.

[0020] Figure 9 yes Figure 8 A partial axial sectional view of a medical interventional system.

[0021] Figure 10 yes Figure 9 An enlarged diagram of the X part in the figure.

[0022] Figure 11 This is a front view of the first element provided in one embodiment of this application.

[0023] Figure 12 yes Figure 11 A three-dimensional exploded view of the first element in the diagram.

[0024] Figure 13 yes Figure 11 A cross-sectional view along the XIII-XIII direction.

[0025] Figure 14 yes Figure 13 A schematic diagram showing the first cap body separated from the first cylinder body.

[0026] Figure 15 yes Figure 13 An enlarged schematic diagram of the XV portion.

[0027] Figure 16 This is a partial cross-sectional view of the first cylinder, the first cap, and the first seal provided in another embodiment of this application.

[0028] Figure 17 This is a front view of the second element provided in one embodiment of this application.

[0029] Figure 18 yes Figure 17 A three-dimensional exploded structure diagram of the second element in the diagram.

[0030] Figure 19 This is a schematic flowchart of the air venting method for a medical interventional system provided in one embodiment of this application.

[0031] Figure 20 This is a schematic diagram of the exhaust path for medical accessories.

[0032] Figure 21 This is a schematic diagram of the exhaust path of the bending sheath.

[0033] Figure 22 This is a schematic diagram of the exhaust path of the delivery sheath. Detailed Implementation

[0034] The technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only a part of the embodiments of this application, and not all of them. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0035] Furthermore, the following descriptions of various embodiments are based on the accompanying illustrations and are used to illustrate specific embodiments that can be implemented in this application. Directional terms used in this application, such as "up," "down," "front," "back," "left," "right," "inner," "outer," and "side," are merely for reference to the accompanying illustrations. Therefore, the directional terms used are for better and clearer explanation and understanding of this application, and are not intended to indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this application.

[0036] It should be noted that, in order to more clearly describe the structure of medical accessories and interventional systems, the limiting terms "proximal" and "distal" used in this application are conventional terms in the field of interventional medicine. Specifically, for instruments used in endovascular interventional surgery, the "distal" end refers to the end furthest from the operator during the surgical procedure, while the "proximal" end refers to the end closest to the operator during the surgical procedure. Furthermore, the direction of the rotational axis of objects such as cylinders and tubes is defined as the axial direction; the circumferential direction is the direction around the axis of the object (perpendicular to the axis and also perpendicular to the cross-sectional radius); and the radial direction is along the diameter or radius.

[0037] It is worth noting that the term "end" appearing in terms such as "proximal end," "distal end," "one end," "the other end," "first end," "second end," "initial end," "end," "both ends," "head end," "upper end," and "lower end" is not limited to a head, end point, or end face, but also includes a portion extending axially and / or radially from the head, end point, or end face on the element to which the head, end point, or end face belongs. Unless otherwise defined, all technical and scientific terms used in this application have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The conventional terminology used in this application's specification is for the purpose of describing particular embodiments only and should not be construed as limiting this application.

[0038] Please combine Figures 1 to 5 This application provides a medical interventional system 1, including a medical implant 20, a delivery device 40, and a medical accessory 60. The medical implant 20 may be, but is not limited to, a valve clip, a vascular stent, etc. The delivery device 40 is used to deliver the medical implant 20 into the patient's body, and the medical accessory 60 is used to protect and / or load the medical implant 20 and the air vent of the medical interventional system 1.

[0039] Specifically, such as Figure 1 and Figure 4 As shown, in some embodiments, the delivery device 40 may include a bending sheath 41 and a delivery sheath 43. The delivery sheath 43 is movably inserted within the bending sheath 41, and the distal end of the delivery sheath 43 is detachably connected to the medical implant 20. The bending sheath 41 and the delivery sheath 43 are respectively provided with a first exhaust valve 412 and a second exhaust valve 432. The first exhaust valve 412 has a communicating state with the inner cavity of the bending sheath 41 and a closed state isolated from the inner cavity of the bending sheath 41. The second exhaust valve 432 has a communicating state with the inner cavity of the delivery sheath 43 and a closed state isolated from the inner cavity of the delivery sheath 43. More specifically, the bending sheath 41 includes a bending sheath tube 414 and a bending handle 416 connected to the proximal end of the bending sheath tube 414, and the delivery sheath 43 includes a delivery sheath tube 434 and a delivery handle 436 connected to the proximal end of the delivery sheath tube 434. The delivery sheath 434 is inserted into the bending sheath 414 by the proximal end of the bending handle 416, and the distal end of the delivery sheath 434 can extend out from the distal end of the bending sheath 414 and is detachably connected to the medical implant 20. A first exhaust valve 412 and a second exhaust valve 432 are respectively disposed on the bending handle 416 and the delivery handle 436. The bending sheath 41 and the delivery sheath 43 can be existing bending sheaths and delivery sheaths, and the first exhaust valve 412 and the second exhaust valve 432 can both be existing three-way valves. The specific structures of the bending sheath 41, the delivery sheath 43, the first exhaust valve 412, and the second exhaust valve 432 are not described in detail here.

[0040] In this application, the medical accessory 60 includes a first element 61 and a second element 62. Specifically, please refer to... Figures 1 to 3 In some embodiments, the first element 61 includes a first cylindrical body 611, a tube 613 sealingly connected to the distal end of the first cylindrical body 611, a first cap 615 detachably connected to the proximal end of the first cylindrical body 611, a first sealing body 617 disposed within the first cylindrical body 611, and a first on / off valve 612 sealingly connected to the inner cavity of the first cylindrical body 611. The first on / off valve 612 has a connected state communicating with the inner cavity of the first element 61 and a closed state isolating it from the inner cavity of the first element 61. For example, Figure 3As shown, the first sealing body 617 has a first inner hole 6172, and the first cap 615 can selectively compress the first sealing body 617 to reduce the diameter of the first inner hole 6172. (Please refer to...) Figure 4 and Figure 5 In some embodiments, the second element 62 includes a second cylinder 621 and a second on-off valve 622 that seals the inner cavity of the second cylinder 621. The second on-off valve 622 has a connected state that communicates with the inner cavity of the second element 62 and a closed state that is isolated from the inner cavity of the second element 62. Similar to the first exhaust valve 412 and the second exhaust valve 432, the first on-off valve 612 and the second on-off valve 622 can also be three-way valves as used in the prior art; their specific structures will not be described in detail here.

[0041] like Figure 5 As shown, in the medical accessory 60 provided in this application, the distal end of the first cylindrical body 611 can be detachably connected to the proximal end of the second cylindrical body 621, so that the first element 61 and the second element 621 are assembled into a whole. In the connected state, the tube 613 extends into the inner cavity of the second cylindrical body 621, and a seal is formed between the tube 613 and the inner cavity of the second cylindrical body 621. Preferably, please refer to... Figures 5 to 7 In some embodiments, the second element 62 further includes a second cap 625 connected to the proximal end of the second cylinder 621 and a second sealing body 627 disposed within the second cylinder 621 or the second cap 625, the second sealing body 627 having a second inner hole 6272. Figures 5 to 7 In the embodiment shown, the distal end of the first cylinder 611 is detachably connected to the proximal end of the second cap 625 to achieve the connection of the first element 61 and the second element 62. In the connected state, the distal end of the tube 613 passes through the second inner hole 6272 and is press-fitted with the second sealing body 627, so that a seal is formed between the tube 613 and the inner cavity of the second cylinder 621.

[0042] In this application, the first element 61 and the second element 62 are used in different states of the medical intervention system 1 when they are separated from each other and when they are assembled into a whole, thereby realizing different functions.

[0043] Specifically, please combine Figures 1 to 3 When the medical interventional system 1 is in its first state, the first element 61 is sleeved on the distal end of the bending sheath 41 (i.e., the distal end of the bending sheath tube 414). The distal end of the bending sheath 41 passes through the first inner hole 6172 of the first sealing body 617 and is held tightly by the first sealing body 617. The inner cavity of the tube body 613 is fitted outside the medical implant 20. The first element 61 functions alone to protect the medical implant 20 contained in the inner cavity of the tube body 613. In this first state, the medical interventional system 1 is mainly used for its packaging, sterilization, and transportation processes.

[0044] It should be noted that, in its natural state, the diameter of the first inner hole 6172 is equal to or greater than the outer diameter of the distal end of the bending sheath 41 (specifically, the outer diameter of the distal end of the bending sheath tube 414), so that the distal end of the bending sheath 41 can pass through the first inner hole 6172; the inner diameter of the tube body 613 is equal to or greater than the outer diameter of the distal end of the bending sheath 41, so that the bending sheath 41, having passed through the first inner hole 6172, can further penetrate into the inner cavity of the tube body 613. Preferably, in some embodiments, the diameter of the first inner hole 6172 is larger than the outer diameter of the distal end of the bending sheath 41 (e.g., 2mm-7mm larger), and the inner diameter of the tube body 613 is also larger than the outer diameter of the distal end of the bending sheath 41 (e.g., 0.2mm-1mm larger), facilitating the rapid passage of the distal end of the bending sheath 41 through the first inner hole 6172 and into the inner cavity of the tube body 613. More preferably, as... Figure 3 As shown, in some embodiments, the first inner hole 6172 is a tapered hole, the inner diameter of which gradually decreases from its proximal end to its distal end. The tapered hole has a larger entry point, which makes it easier for the distal end of the bending sheath 41 to pass through.

[0045] Understandably, when the first cap 615 selectively compresses the first sealing body 617 to reduce the diameter of the first inner hole 6172, the first sealing body 617 can hold the distal end of the bending sheath 41 passing through the first inner hole 6172, thereby achieving a seal between the first element 61 and the bending sheath 41; when the first sealing body 617 is not compressed by the first cap 615, there are gaps between the first inner hole 6172 and the tube 613 and the bending sheath 41, allowing the first element 61 to move along the axial direction of the bending sheath 41 without resistance.

[0046] It should also be noted that the minimum inner diameter of the first cylindrical body 611 is greater than the maximum outer diameter of the medical implant 20, and less than or equal to the inner diameter of the tube 613. This ensures that there are no steps protruding from the inner wall of the first cylindrical body 611 between the tube 613 and the first cylindrical body 611, facilitating the smooth entry of the medical implant 20 into the tube 613 through the inner cavity of the first cylindrical body 611. Furthermore, the medical implant 20 is not subjected to radial compression within the tube 613, preventing damage to its structure. For example, in one possible embodiment, the inner diameter of the tube 613 is 3mm-8mm, which is 0.5mm-2mm larger than the maximum outer diameter of the medical implant 20, and 0.2mm-1mm larger than the minimum inner diameter of the first cylindrical body 611.

[0047] Please combine Figure 4 and Figure 5When the medical intervention system 1 is in its second state, the first element 61 is sleeved on the distal end of the bending sheath 41 and connected to the second element 62. The distal end of the bending sheath 41 passes through the first inner hole 6172 of the first sealing body 617 and is held tightly by the first sealing body 617. The medical implant 20 is housed in the inner cavity of the tube body 613. The first element 61 and the second element 62 work together to expel air from the medical intervention system 1 through the first on / off valve 612, the second on / off valve 622, the first exhaust valve 412, and the second exhaust valve 432. The second state of the medical intervention system 1 is primarily used for air venting; the specific venting method will be described in detail later.

[0048] Furthermore, please combine Figures 8 to 10 In some embodiments, the delivery device 40 further includes a guide sheath 45, which includes a guide sheath tube 454 and a guide handle 456 connected to the proximal end of the guide sheath tube 454. The guide sheath 45 is used to establish an interventional channel. The bent sheath tube 414 is movably inserted into the guide sheath tube 454 via the guide handle 456, thereby implanting the medical implant 20 into the patient's body through the interventional channel established by the guide sheath 45. That is, in some embodiments, the medical interventional system 1 also has a third state for delivering the medical implant 20 into the patient's body.

[0049] Specifically, such as Figures 8 to 10 As shown, when the medical intervention system 1 is in the third state, the first element 61 is sleeved on the distal end of the bending sheath 41, and the distal end of the bending sheath 41 passes through the first inner hole 6172 of the first sealing body 617 and is held tightly by the first sealing body 617. The medical implant 20 is housed in the inner cavity of the tube body 613. The first element 61 acts 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. Thereafter, while maintaining the relative position of the first element 61 and the guide sheath 45, the bending sheath 41 and the delivery sheath 43 are pushed synchronously. The delivery device 40 then pushes the medical implant 20 to the predetermined treatment site through the intervention channel established by the guide sheath 45. It should be noted that after the intervention channel of the guide sheath 45 is established, the medical intervention system 1 that has completed the venting needs to first disconnect the connection between the first element 61 and the second element 62, remove the second element 62, and then connect the guide sheath 45 to the first element 61 so that the first element 61 can be used alone in the third state of the medical intervention system 1.

[0050] The guide sheath 45 can be a guide sheath of the prior art, and its specific structure will not be described in detail here. Optionally, an injection valve 452 communicating with the inner cavity of the guide sheath 45 can be provided on the guide handle 456 of the guide sheath 45. Liquid (e.g., physiological saline) is injected through the injection valve 452 to expel air from the guide sheath 45, preventing air from being introduced into the patient's body and causing air embolism. The injection valve 452 can be a three-way valve of the prior art, and its details will not be elaborated here.

[0051] In summary, the medical interventional system 1 and medical accessory 60 provided in this application include a first element 61 and a second element 62 detachably connected thereto. When the first element 61 is used alone, it can be used to protect and / or load the medical implant 20. When the first element 61 and the second element 62 are assembled into a single unit, the medical accessory 60 can be used to expel air from the medical interventional system 1 containing the medical implant 20. Therefore, the medical interventional system 1 does not require separate components for the protection and loading of the medical implant 20, as well as for the venting of the entire system, resulting in a simple overall structure, convenient operation, and reduced surgical time.

[0052] It should be noted that, in this application, except for the first sealing body 617, the second sealing body 627, the first on / off valve 612, and the second on / off valve 622, the other components of the first element 61 and the second element 62 are preferably obtained from materials with excellent light transmittance through machining, injection molding, or extrusion molding. The materials with excellent light transmittance can be, but are not limited to, one or a mixture of at least two of the following: polymethyl methacrylate, polystyrene, polycarbonate, and styrene-methyl methacrylate copolymer resin. Different components of the first element 61 and the second element 62 can be made of the same material or different materials.

[0053] Preferably, in some embodiments, the other components of the first element 61 and the second element 62 described above are made of highly transparent polycarbonate material and obtained by extrusion molding. For example... Figure 2 and Figure 5As shown, due to the high transparency of the other components of the first element 61 and the second element 62, when the first element 61 is sleeved on the distal end of the bending sheath 41 and the medical implant 20 is housed within the tube 613, the operator can clearly see the specific position of the medical implant 20 within the tube 613. It is easy to understand that when the medical implant 20 is not in a safe and effective position within the tube 613, the operator can directly observe and adjust the medical implant 20 to a safe and effective position within the tube 613. It should be noted that, for the tube 613, except for a certain length (e.g., 10%) at both ends, the middle portion of the tube 613 effectively protects the medical implant 20; that is, the safe and effective position of the tube 613 refers to the middle position of the tube 613 (e.g., the position occupying approximately 80% of the axial length between the two ends of the tube 613). In order to ensure that common medical implants such as valve clips and vascular stents can be safely and effectively housed in the tube body 613, and to ensure that the tube body 613 has a certain strength, the wall thickness of the tube body 613 ranges from 0.3mm to 1.5mm, and the length ranges from 30mm to 100mm.

[0054] In this application, the first sealing body 617 and the second sealing body 627 can be made of elastic materials such as nitrile rubber, thermoplastic polyurethane, silicone, polytetrafluoroethylene, and nylon elastomer, and obtained by injection molding. Preferably, in some embodiments, the first sealing body 617 and the second sealing body 627 are made of silicone, and the hardness range of the first sealing body 617 and the second sealing body 627 is 30A-60A.

[0055] Please combine Figures 11 to 14 In some embodiments, the first cylindrical body 611 may include a threaded section 6112, a transition section 6114, and a plug section 6116 connected sequentially from the proximal end to the distal end. The threaded section 6112 is used to connect the first cap 615 and accommodate the first sealing body 617, the plug section 6116 is used to connect the tube body 613, and the transition section 6114 is used for the medical implant 20 to be transitionally inserted into the tube body 613.

[0056] Specifically, such as Figures 12 to 14 As shown, 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 615 is an annular cap, which has internal threads corresponding to the external threads of the threaded section 6112 at least on its distal inner wall. The first cap 615 is detachably connected to the outside of the threaded section 6112 by means of a threaded connection. The inner cavity of the threaded section 6112 is used to accommodate the first sealing body 617 (see...). Figure 13 ).

[0057] like Figures 12 to 14As shown, the outer diameter of the insertion segment 6116 is consistent from the proximal end to the distal end and is smaller than the outer diameter of the screw-in segment 6112. The inner cavity of the insertion segment 6116 is used to insert the proximal end of the connector body 613. Optionally, as... Figure 13 As shown, in some embodiments, the inner diameter of the insertion segment 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 inner cavity of the insertion segment 6116, there is a gap between the outer wall of the tube body 613 and the inner wall of the insertion segment 6116. By injecting glue into this gap, the tube body 613 and the insertion segment 6116 can be bonded and fixed, thereby sealing the proximal end of the tube body 613 to the distal end of the first cylinder 611. For example, in one possible embodiment, the outer diameter of the tube body 613 is 0.5mm-1.5mm smaller than the inner diameter of the insertion segment 6116. The purpose is to provide sufficient glue injection space when the tube body 613 and the first cylinder 611 are inserted, ensuring the firmness of the bond between the tube body 613 and the first cylinder 611 and the sealing between them. It is easy to understand that there should be a sufficient bonding length (e.g., 0.6mm-2.0mm) between the tube body 613 and the insertion section 6116 to ensure the reliability of the bonding between them. The adhesive used can be instant adhesive, medical adhesive, or UV adhesive, etc. It should be noted that the outer contour of the tube body 613 matches the inner contour of the insertion section 6116. The tube body 613 can be, but is not limited to, a circular tube, a rectangular tube, or a polygonal tube, and the cross-sectional shape of the inner cavity of the tube body 613 can be, but is not limited to, a circle, a rectangle, or a polygon; there is no limitation on this. In the embodiments of this application, the tube body 613 is a circular tube with a circular cross-section inner cavity.

[0058] In some other embodiments, the proximal end of the tube 613 can be sealed to the distal end of the first cylinder 611 by means of threaded connection or snap-fit ​​connection. In other embodiments, the tube 613 can also be integrally formed with the first cylinder 611.

[0059] Furthermore, please combine Figure 5 , Figure 6 and Figure 13 As shown, in some embodiments, the outer wall of the insertion section 6116 is provided with external threads, and the proximal inner cavity of the second cap 625 is correspondingly provided with internal threads. The second cap 625 is fitted onto the insertion section 6116 via a threaded connection, achieving a detachable connection between the distal end of the first cylinder 611 and the proximal end of the second cap 625. Preferably, the insertion section 6116 and the second cap 625 are connected by a double-threaded connection, with the number of thread turns being 1-3 turns. Compared to a single-threaded thread with the same pitch, the double-threaded connection between the insertion section 6116 and the second cap 625 results in a travel distance of twice that of a single-threaded thread, and the thread strength is twice that of a single-threaded thread, facilitating faster operation, reducing operation time, and improving connection strength.

[0060] In other embodiments, the distal end of the first cylindrical body 611 and the proximal end of the second cap 625 can also be detachably connected by other means, such as a snap-fit ​​connection. Specifically, in one possible embodiment, the outer wall of the insertion section 6116 of the first cylindrical body 611 is provided with at least two snaps spaced apart circumferentially (preferably symmetrically distributed about the central axis of the first cylindrical body 611), and the inner wall of the proximal end of the second cap 625 is provided with at least two slots corresponding to the at least two snaps on the insertion section 6116. Each slot includes a guide portion extending axially along the second cap 625 and a stop portion communicating with the guide portion and extending circumferentially along the second cap 625, wherein the slot width of the stop portion is slightly larger than the width of the snap (e.g., 0.05mm-0.10mm larger). During use, each latch on the plug section 6116 is slowly pushed along the guide part of the corresponding slot. When the latch is pushed to the bottom of the guide part of the slot, the first cylinder 611 is rotated so that the edge of the latch reaches the edge of the stop part of the slot, and the first cylinder 611 can no longer rotate. In this way, the first cylinder 611 and the second cap 625 will not move axially due to the limiting effect of the stop part of the slot on the latch. Moreover, the width of the slot and the gap between the latch and the fit are small (only 0.05mm-0.10mm). The first cylinder 611 and the second cap 625 are not easy to rotate relative to each other without being subjected to external force, thereby realizing the detachable connection between the far end of the first cylinder 611 and the second cap 625.

[0061] like Figures 12 to 14 As shown, transition section 6114 connects between screw section 6112 and insertion section 6116. The inner cavity of transition section 6114 is used for the medical implant 20, which passes through the first sealing body 617 in screw section 6112, to transition into insertion section 6116 and further into tube body 613. Preferably, in Figures 13 to 14 In the embodiment shown, 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. The transition section 6114 can serve as a support and guide, allowing the medical implant 20 to smoothly enter the tube body 613.

[0062] like Figure 12As shown, in some embodiments, the first cylinder 611 further includes a first short pipe 6118 for connecting the first on / off valve 612. The first short pipe 6118 protrudes radially from the outer peripheral wall of the transition section 6114 and communicates with the inner cavity of the transition section 6114. The first short pipe 6118 extends along a direction perpendicular to the central axis of the first cylinder 611 and communicates with the first on / off valve 612 through a first connecting pipe (not labeled in the figure). The first connecting pipe may be made of, but is not limited to, polytetrafluoroethylene, thermoplastic polyurethane, etc., and the first short pipe 6118 and the first connecting pipe are bonded together using medical adhesive, instant adhesive, or UV adhesive. The length of the first connecting pipe is moderate, typically 4mm-10mm.

[0063] In some other embodiments, the first on / off valve 612 can be directly connected to the first short pipe 6118 of the first cylinder 611, thus eliminating the need for a first connecting pipe. In other embodiments, the first cylinder 611 may also omit the first short pipe 6118 and instead have a port directly opened on the outer peripheral wall of the transition section 6114. The first on / off valve 612 is connected to the port on the transition section 6114 via the first connecting pipe, or the first on / off valve 612 is directly connected to the port on the transition section 6114, thereby connecting the inner cavity of the first cylinder 611. No limitation is imposed on this approach.

[0064] As previously described, in some embodiments, the first sealing body 617 is disposed within the inner cavity of the threaded section 6112. Specifically, as... Figures 12 to 15 As shown, the first sealing body 617 is an annular elastic sealing body. Its proximal portion has a first inner hole 6172 in the shape of a cone, and its distal portion has a groove connecting the inner cavity of the transition section 6114 and the first inner hole 6172. It should be noted that, in its natural state, the outer diameter of the first sealing body 617 is consistent from the proximal end to the distal end and is larger than the inner diameter of the threaded section 6112. The first sealing body 617 can be elastically compressed into the inner cavity of the threaded section 6112, so that the threaded section 6112 and the entire outer peripheral wall of the first sealing body 617 are in compression contact, thereby achieving a seal between the first sealing body 617 and the first cylinder 611.

[0065] Preferably, in Figures 12 to 15In the illustrated embodiment, the proximal inner wall of the first cylindrical body 611 (i.e., the inner wall of the threaded section 6112) is provided with a stop portion 6119. Specifically, the stop portion 6119 is a step formed at the connection between the threaded section 6112 and the transition section 6114 (i.e., the inner diameter of the threaded section 6112 is at least larger than the inner diameter of the portion of the transition section 6114 connecting the threaded section 6112). The first cap 615 is provided with a top abutment 6159. The top abutment 6159 includes a connecting section (not labeled in the figure) connected to the proximal end of the first cap 615 and extending radially inward along the first cap 615, and a top abutment section (not labeled in the figure) connected to the connecting section near the central axis of the first cap 615 and extending axially distally along the first cap 615. A radial gap exists between the top abutment section and the proximal inner wall of the first cap 615. Figure 13 and Figure 15 As shown, when the first sealing body 617 is housed in the inner cavity of the proximal end of the first cylindrical body 611 (i.e., the inner cavity of the threaded section 6112) and the first cap 615 is connected to the proximal end of the first cylindrical body 611, the proximal portion of the threaded section 6112 is located within the gap between the abutting section of the abutment top 6159 and the inner wall of the first cap 615, and the first sealing body 617 is located between the stop portion 6119 and the abutment top 6159. It can be understood that, in Figure 13 and Figure 15In the embodiment shown, the first cap 615 can rotate relative to the first cylinder 611 and move axially toward the distal end relative to the first cylinder 611, so that the abutting section of the abutting top 6159 presses the proximal end of the first sealing body 617 in the axial direction. Since the outer peripheral wall of the first sealing body 617 is bound by the inner wall of the threaded section 6112 of the first cylinder 611, and the distal end of the first sealing body 617 is abutted by the stop part 6119, the first sealing body 617 will deform radially toward the central axis of the first inner hole 6172 while being pressed in the axial direction, thereby reducing the inner diameter of the first inner hole 6172. It should be noted that when the proximal portion of the threaded section 6112 is located within the gap between the abutment section of the abutment top 6159 and the inner wall of the first cap 615, there is a sufficiently long axial distance between the proximal end of the threaded section 6112 and the connecting section of the abutment top 6159, so that the abutment top 6159 can move a sufficiently long distance axially to the distal end, thereby enabling the abutment section of the abutment top 6159 to generate sufficient axial compression on the first sealing body 617 (e.g., 0.5mm-2.5mm), thus ensuring that the first sealing body 617 has sufficient interference compression between itself and the bending sheath 41 in the radial direction (e.g., the single-sided compression of the first sealing body 617 is 0.5mm-1mm), ensuring that the diameter of the first inner hole 6172 can be reduced to tightly grip the distal end of the bending sheath 41 passing through the first inner hole 6172. It is easy to understand that when the first cap 615 rotates in the opposite direction relative to the first cylinder 611 so that the first cap 615 moves towards the proximal end of the first cylinder 611 in the axial direction, the axial compression of the top section on the first sealing body 617 gradually decreases, and the radial deformation of the first sealing body 617 gradually decreases, so that the diameter of the first inner hole 6172 gradually increases until the diameter of the first inner hole 6172 increases to the point that it no longer contacts the bending sheath 41, and the first sealing body 617 no longer holds the bending sheath 41 tightly.

[0066] Please combine Figure 16In other embodiments, the outer diameter of the first sealing body 617 may be inconsistent from the proximal end to the distal end. The first sealing body 617 consists of a fixing part (not labeled in the figure) with a circular structure at the distal end and a pressing part (not labeled in the figure) with a frustum-shaped structure at the proximal end. In its natural state, the outer diameter of the fixing part is consistent and larger than the inner diameter of the threaded section 6112, while the outer diameter of the pressing part gradually increases from the proximal end to the distal end. The fixing part is elastically pressed into the inner cavity of the threaded section 6112, causing the threaded section 6112 to press against the outer peripheral wall of the fixing part of the first sealing body 617 to form a seal. The outer peripheral wall of the pressing part of the first sealing body 617 has a first conical surface 6177. The radial distance between the first conical surface 6177 and the axis of the first sealing body 617 gradually increases from the proximal end to the distal end of the first conical surface 6177. The abutment 6159 of the first cap 615 has a second conical surface 6157 that is opposite to and adapted to the first conical surface 6177. The taper of the first conical surface 6177 and the second conical surface 6157 can be the same, meaning they are parallel. Furthermore, the minimum radial dimension of the second conical surface 6157 (i.e., the inner diameter near the top 6159) is smaller than the minimum radial dimension of the first conical surface 6177 (i.e., the outer diameter near the first sealing body 617). It is understood that in... Figure 16 In the illustrated embodiment, the first cap 615 rotates relative to the first cylinder 611 while moving axially to the distal end relative to the first cylinder 611, so that the second conical surface 6157 of the top 6159 gradually presses the first conical surface 6177 of the first sealing body 617. Since the first conical surface 6177 and the second conical surface 6157 are parallel conical surfaces, the top 6159 applies a pressing force perpendicular to the first conical surface 6177 to the first sealing body 617. Under the action of this pressing force, the top 6159 simultaneously presses the pressing part of the first sealing body 617 in both the axial and radial directions, causing the first sealing body 617 to deform simultaneously in both the axial and radial directions, thereby reducing the diameter of the first inner hole 6172. This allows the first sealing body 617 to tightly hold the bending sheath 41 passing through the first inner hole 6172, achieving a sealing effect.

[0067] In the above embodiment, the first cap 615 can rotate relative to the first cylinder 611 while moving axially relative to the first cylinder 611, thereby squeezing the first sealing body 617 in the axial and / or radial directions, so as to reduce the diameter of the first inner hole 6172, thereby achieving the clamping and sealing between the first sealing body 617 and the bending sheath 41.

[0068] In other embodiments, the first cap 615 may be configured to rotate relative to the first cylinder 611 or move axially relative to the first cylinder 611, thereby pressing the first sealing body 617 in the axial and / or radial directions, which can also achieve the clamping and sealing between the first sealing body 617 and the bending sheath 41, which will not be described in detail.

[0069] In other words, in this application, the first cap 615, which is detachably connected to the proximal end of the first cylinder 611, can be configured to rotate and / or move axially relative to the first cylinder 611 and press the first sealing body 617 inside the first cylinder 611 in the axial and / or radial directions, thereby reducing the diameter of the first inner hole 6172 to achieve the clamping and sealing between the first sealing body 617 and the bending sheath 41.

[0070] Please refer to it again. Figures 1 to 3 In this application, when the medical interventional system 1 is in its first state, i.e., during the packaging, sterilization, and transportation of the medical interventional system 1, the first element 61 is not connected to the second element 62, and the first element 61 is sleeved on the distal end of the bending sheath 41 (specifically, the distal end of the bending sheath tube 414). Specifically, as... Figures 1 to 3 As shown, the distal end of the delivery sheath 43 (specifically the distal end of the delivery sheath tube 434) is detachably connected to the medical implant 20, and after the medical implant 20 is exposed outside the distal end of the bending sheath tube 414, the operator needs to retract the medical implant 20 into the inner cavity of the tube body 613 of the first element 61. Before the medical implant 20 enters the safe and effective position inside the tube body 613, the first cap 615 of the nut structure is in the initial untightened state, that is, the first cap 615 is not rotated relative to the first cylinder 611. At this time, the first sealing body 617 is not subjected to axial compressive force, the first inner hole 6172 of the first sealing body 617 does not change, the first sealing body 617 does not hold the bending sheath tube 414 tightly, and the first element 61 can move on the bending sheath tube 414 without resistance. After the first element 61 is slowly moved so that the medical implant 20 is retracted into a safe and effective position in the tube 613, the first cap 615 is controlled to rotate relative to the first cylinder 611 so that the first cap 615 moves axially distally relative to the first cylinder 611. The first cap 615 squeezes the first sealing body 617, thereby reducing the diameter of the first inner hole 6172. This causes the first sealing body 617 to grip the bending sheath 414, thereby fixing the first element 61 on the distal end of the bending sheath 414. The medical implant 20 is accommodated in a safe and effective position in the tube 613, and the tube 613 can effectively protect the medical implant 20 from damage in all stages before the operation.

[0071] Please combine Figures 5 to 7 , Figure 17 as well as Figure 18In some embodiments, the second cylindrical body 621 is a hollow tube with a circular cross-section cavity, the inner diameter of which is larger than the outer diameter of the tube 613 (e.g., 0.5mm-3.5mm larger), so that the tube 613 can be inserted into the cavity of the second cylindrical body 621. The axial length of the second cylindrical body 621 is longer than the axial length of the portion of the tube 613 exposed above the first cylindrical body 611 (e.g., 3mm-15mm longer), so that the portion of the tube 613 exposed above the first cylindrical body 611 can be completely accommodated within the cavity of the second cylindrical body 621. Figure 6 As shown, the distal end of the second cylinder 621 is provided with a second short pipe (not labeled in the figure) that communicates with its inner cavity. The second short pipe is connected to the second on-off valve 622 through a second connecting pipe (not labeled in the figure). In other embodiments, similar to the first on-off valve 612, the second on-off valve 622 can also be directly connected to the distal end of the second cylinder 621 or other reasonable location, thus eliminating the need for a second connecting pipe; alternatively, the second cylinder 621 may not have a second short pipe and can directly open a connection port at its distal end or other reasonable location. The second on-off valve 622 can be connected to this port through the second connecting pipe or directly connected to this port, thereby communicating with the inner cavity of the second cylinder 621. This is not limited.

[0072] exist Figures 5 to 7 , Figure 17 as well as Figure 18 In the illustrated embodiment, the second sealing body 627 can be an annular elastic sealing body, and the second sealing body 627 is disposed in the proximal inner cavity of the second cylinder 621. In its natural state, the outer diameter of the second sealing body 627 is consistent from the proximal end to the distal end and is larger than the inner diameter of the proximal inner cavity of the second cylinder 621. The second sealing body 627 can be elastically compressed into the proximal inner cavity of the second cylinder 621, causing the outer peripheral wall of the second cylinder 621 to press against the outer wall of the second sealing body 627 to form a seal. Furthermore, the diameter of the second inner hole 6272 of the second sealing body 627 is smaller than the outer diameter of the tube 613, for example, it can be 1mm-3mm smaller. By designing the difference between the diameter of the second inner hole 6272 and the outer diameter of the tube body 613 to be within a reasonable range (such as the aforementioned 1mm-3mm), the resistance of the tube body 613 entering the second cylinder 621 will not be too great. When the tube body 613 is inserted into the second cylinder 621 and passes through the second inner hole 6272, the tube body 613 and the second sealing body 627 are in an interference fit, thereby ensuring that the second sealing body 627 has a good sealing effect on the tube body 613.

[0073] Preferably, such as Figure 6 and Figure 7As shown, in some embodiments, an annular clearance groove is formed on the proximal inner wall of the second cylinder 621. A stop step is formed at the bottom of the annular clearance groove along the axial direction of the second cylinder 621. When the second sealing body 627 is disposed inside the second cylinder 621, the stop step abuts against the distal end of the second sealing body 627, thereby preventing the second sealing body 627 from moving axially to the distal end. Further, in Figure 6 and Figure 7 In the illustrated embodiment, the second cap 625 includes a nut at its proximal end and a tube connected to the distal end of the nut. When the second cap 625 is connected to the proximal end of the second cylinder 621, the distal end of the tube is received within an annular clearance groove at the proximal end of the second cylinder 621, and the distal end of the tube abuts against the proximal end of the second sealing body 627, thereby preventing the second sealing body 627 from moving axially towards the proximal end. The opposite ends of the second sealing body 627 are respectively abutted by the stop step of the second cylinder 621 and the tube of the second cap 625, restricting the axial movement of the second sealing body 627. This helps to improve the stability of the second sealing body 627 within the second cylinder 621, thereby ensuring the sealing reliability between the second sealing body 627 and the tube body 613.

[0074] Among them, such as Figure 6 and Figure 7 As shown, in some embodiments, the inner diameter of the annular clearance groove of the second cylinder 621 is larger than the outer diameter of the insertion tube of the second cap 625. A gap exists between the circumferential sidewall of the annular clearance groove and the outer circumferential wall of the insertion tube. By injecting adhesive into the gap, the second cylinder 621 and the second cap 625 are bonded together, thereby connecting the second cap 625 to the proximal end of the second cylinder 621. Preferably, the second sealing body 627 can also be bonded to the second cylinder 621 and / or the second cap 625 together with adhesive, which can improve the stability of the second sealing body 627. The adhesive can be instant adhesive, medical adhesive, or UV adhesive, etc. More preferably, an annular receiving groove is formed on the outer peripheral wall of the distal end of the cannula, and an annular tongue is provided on the proximal end of the second sealing body 627. When the distal end of the cannula abuts against the proximal end of the second sealing body 627, the annular tongue overlaps the outer peripheral wall of the distal end of the cannula and is received in the annular receiving groove. In this way, the bonding area between the second sealing body 627 and the second cap 625 is increased, which is beneficial to improving the bonding reliability between the second sealing body 627 and the second cap 625.

[0075] In other embodiments, the circumferential sidewall of the annular clearance groove may be provided with internal threads, and the outer circumferential wall of the insertion tube may be provided with external threads. The second cap 625 may be connected to the near end of the second cylinder 621 by means of threaded connection, preferably by double thread connection. Threaded connection is convenient for disassembly and disassembly and assembly are faster.

[0076] It is understood that in other embodiments, the second sealing body 627 can also be disposed inside the insertion tube of the second cap 625 by means of bonding or other methods, which can also achieve the sealing between the second sealing body 627 and the tube 613 passing through the second inner hole 6272. This will not be elaborated further.

[0077] As mentioned above, in some embodiments, when the first element 61 and the second element 62 work together, the air in the medical intervention system 1 can be removed before the operation by the coordinated use of the first on / off valve 612, the second on / off valve 622, the first exhaust valve 412 and the second exhaust valve 432, so as to avoid the air in the medical intervention system 1 from entering the blood vessels and causing air embolism.

[0078] Specifically, please combine Figure 4 , Figure 5 and Figure 19 This application also provides a method for venting air from a medical interventional system 1, which includes steps S1 and S2, as detailed below.

[0079] Step S1: As Figure 4 and Figure 5 As shown, the first element 61 is sleeved onto the distal end of the bending sheath 41 (specifically, the distal end of the bending sheath tube 414) and connected to the second element 62, so that the distal end of the bending sheath 41 passes through the first inner hole 6172 and is held tightly by the first sealing body 617, and the medical implant 20 is housed in the inner cavity of the tube body 613. Wherein, as... Figure 4 and Figure 5 As shown, when the first element 61 is detachably connected to the second element 62, the tube 613 extends into the inner cavity of the second cylinder 621. The medical implant 20, which is detachably connected to the distal end of the delivery sheath 43 (specifically the distal end of the delivery sheath tube 434), is also located inside the second cylinder 621 along with the tube 613. A seal is formed between the tube 613 and the inner cavity of the second cylinder 621, so that the inner cavity of the second cylinder 621 (i.e., the inner cavity of the second element 62), the inner cavity of the first cylinder 611 (i.e., the inner cavity of the first element 61), the inner cavity of the bending sheath 41, and the inner cavity of the delivery sheath 43 are sealed and connected.

[0080] Step S2: Keep any two of the following closed: the second on / off valve 622 sealing the inner cavity of the second element 62, the first exhaust valve 412 sealing the inner cavity of the bending sheath 41, and the second exhaust valve 432 sealing the inner cavity of the delivery sheath 43. Open the remaining valve together with the first on / off valve 612 sealing the inner cavity of the first element 61, and inject liquid (not limited to physiological saline) into the first on / off valve 612 until the liquid flows out from the remaining valve. It should be noted that in some embodiments, the operator sequentially opens the first on / off valve 612 together with the second on / off valve 622, the first exhaust valve 412, and the second exhaust valve 432 to act as the liquid injection valve and outflow valve, respectively, thereby sequentially expelling air from the medical accessory 60, the bending sheath 41, and the delivery sheath 43.

[0081] More specifically, please combine Figures 20 to 22 In some embodiments, step S2 of the venting method of the medical intervention system 1 sequentially includes the following venting operations.

[0082] First step, such as Figure 20 In the exhaust path A1-A2 shown, with the first shut-off valve 612, the second shut-off valve 622, the first exhaust valve 412, and the second exhaust valve 432 all closed, the second shut-off valve 622 is placed in the highest position (the highest position in the direction of gravity), the first shut-off valve 612 and the second shut-off valve 622 are opened, and liquid is injected into the first shut-off valve 612 until the liquid flows out from the second shut-off valve 622 to expel the air in the medical accessory 60, that is, to expel the air in the first element 61 and the second element 62.

[0083] It should be noted that before performing the first step, the operator needs to control the rotation of the first cap 615 relative to the first cylinder 611 to tighten the first cap 615, causing the first cap 615 to compress the first sealing body 617 inside the first cylinder 611, thereby reducing the diameter of the first inner hole 6172. This ensures that the first sealing body 617 tightly grips the distal end of the bending sheath 41, while the second sealing body 627 seals the outer periphery of the tube 613. Furthermore, after the liquid flows out from the second shut-off valve 622, the operator needs to close the second shut-off valve 622 first and then close the first shut-off valve 612. Liquid injection can only be stopped after confirming that the first shut-off valve 612 is closed. This prevents air from being introduced into the inner cavity of the medical accessory 60.

[0084] Understandably, since all other components of the medical accessory 60, except for the first sealing body 617 and the second sealing body 627, are made of materials with excellent light transmission properties, after completing the first step of the venting operation, the operator can observe whether there is still residual air in the tube 613 used to accommodate the medical implant 20. If there are still air bubbles attached to the inner surface of the tube 613, the first cylinder 611 and the tube 613 can be gently tapped to make the air bubbles gather together, and the first step of the venting operation can be repeated until liquid flows out of the second shut-off valve 622 and no air bubbles appear, ensuring that the air in the inner cavity of the medical accessory 60 is completely vented.

[0085] The second step, as Figure 21 As shown in the B1-B2 venting path, after completing the first venting operation, with the first shut-off valve 612, the second shut-off valve 622, the first venting valve 412, and the second venting valve 432 all closed, the first venting valve 412 is placed in its highest position. The first shut-off valve 612 and the first venting valve 412 are then opened, and liquid is injected into the first shut-off valve 612 until it flows out, thus expelling air from the bending sheath 41. After the liquid flows out of the first venting valve 412, the operator must first close the first venting valve 412 and then close the first shut-off valve 612. Liquid injection can only be stopped after confirming that the first shut-off valve 612 is closed. This prevents air from being carried into the inner cavity of the bending sheath 41.

[0086] Generally, the bending handle 416 is also equipped with a transparent part. Therefore, after completing the second step of the venting operation, the operator can observe through the transparent part of the bending handle 416 whether there are still residual air bubbles in the inner cavity of the bending handle 416. If there are still air bubbles on the inner surface 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 the second step of the venting operation can be repeated until liquid flows out of the first venting valve 412 and no air bubbles appear, thereby ensuring that the air in the inner cavity of the bending sheath 41 is completely vented.

[0087] The third step, as Figure 22 As shown in the C1-C2 venting path, after completing the second venting operation, with the first on-off valve 612, the second on-off valve 622, the first venting valve 412, and the second venting valve 432 all closed, place the second venting valve 432 in its highest position, open the first on-off valve 612 and the second venting valve 432, and inject liquid into the first on-off valve 612 until the liquid flows out from the second venting valve 432 to expel the air from the delivery sheath 43. When the liquid flows out from the second venting valve 432, the operator must first close the second venting valve 432 and then close the first on-off valve 612. Liquid injection can only be stopped after confirming that the first on-off valve 612 is closed. This prevents air from being carried into the inner cavity of the delivery sheath 43.

[0088] like Figure 22 As shown, the conveying handle 436 is usually provided with an observation window 4361 made of transparent material. After completing the third step of the venting operation, the operator can observe through the observation window 4361 whether there are still residual air bubbles in the inner cavity of the conveying handle 436. If there are still air bubbles attached to the inner surface of the conveying handle 436, the outer shell of the conveying handle 436 can be lightly flicked to make the air bubbles gather together, and the third step of the venting operation can be repeated until liquid flows out of the second venting valve 432 and no air bubbles appear, thereby ensuring that the air in the inner cavity of the conveying sheath 43 is completely vented.

[0089] After completing the above venting process, the operator can observe whether there are any residual air bubbles in the medical accessory 60, the bending handle 416, and the delivery handle 436. If there are still residual air bubbles, the above three-step venting operation needs to be repeated until the air in the cavity of the medical intervention system 1 is completely vented.

[0090] It is understood that in other embodiments, when the first sealing body 617 holds the distal end of the bending sheath 41, step S2 in the venting method of the medical intervention system 1 can also vent the air in the medical accessory 60, the bending sheath 41 and the delivery sheath 43 in other orders. For example, the air in the bending sheath 41 can be vented first, then the air in the delivery sheath 43 can be vented, and finally the air in the medical accessory 60 can be vented. As long as the air in the cavity of the medical intervention system 1 is vented by repeating several venting operations, there is no limitation on this.

[0091] Furthermore, please combine again Figures 8 to 10 As mentioned above, in some embodiments, after the medical intervention system 1 completes the venting, the operator can disconnect the first element 61 from the second element 62 and remove the second element 62. Then, the guide sheath 45 is sleeved with the first element 61 so that the medical implant 20 is loaded into the guide sheath 45. The operator can push the medical implant 20 to the predetermined treatment site through the intervention channel established by the guide sheath 45 of the delivery device 40.

[0092] Specifically, such as Figures 8 to 10 As shown, when the guide sheath 45 is sleeved with the first element 61, the distal end of the tube body 613 is inserted into the proximal inner cavity of the guide sheath 45, and the medical implant 20 housed within the tube body 613 also enters the proximal inner cavity of the guide sheath 45. Wherein, as Figure 9 and Figure 10As shown, in some embodiments, the guide sheath 45 includes a sealing gasket 451 and a transition member 453. The sealing gasket 451 is made of an elastic material (e.g., but not limited to silicone) and has a cut (which may be, but is not limited to, a cross-shaped cut or a circular cut). The sealing gasket 451 is used to allow the tube body 613 to pass through and to seal the outer periphery of the tube body 613, thereby achieving a sealed connection between the tube body 613 and the guide sheath 45. The transition member 453 is located on the distal end of the sealing gasket 451 and is used to abut against the distal end of the tube body 613, thereby serving a limiting function. Preferably, as shown... Figure 10 As shown, the transition member 453 has a tapered hole, the diameter of which 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. The distal end of the tube body 613 extends into the transition member 453 from the proximal end of the tapered hole and abuts against the inner wall of the transition member 453. The tube body 613 can easily extend into the transition member 453 through the tapered hole, and a buffered contact can be achieved between the tube body 613 and the transition member 453, thereby avoiding hard contact and protecting the tube body 613.

[0093] like Figures 8 to 10 As shown, after establishing an interventional channel through the guide sheath 45, the second element 62 in the medical interventional system 1, after venting, is removed from the distal end of the first element 61. The tube 613 containing the medical implant 20 is passed through the incision position of the sealing gasket 451, and the first element 61 is pushed forward until the distal end of the tube 613 reaches the position of the transition piece 453 inside the guide sheath 45. At this time, the first element 61 establishes a safe channel for the medical implant 20 to enter the inner cavity of the guide sheath 45. Afterward, the first cap 615 of the first element 61 can be slightly loosened to appropriately reduce the size of the first sealing body 617. The clamping force of the curved sheath 414 allows it to move relative to the first sealing body 617 while maintaining a seal. The medical implant 20 is driven by the curved sheath 41 and the delivery sheath 43 and smoothly enters the inner cavity of the guide sheath 45. Then, along the channel established by the first element 61 and the guide sheath 45, the medical implant 20 is smoothly delivered to the designated location (e.g., the left atrium) in the patient's body through the delivery sheath 43 and the curved sheath 41. Then, by manipulating the various handles, the medical implant 20 is released and left in the patient's body, thereby completing the corresponding interventional surgery (e.g., mitral valve edge-to-edge repair).

[0094] It should be noted that during the process of the medical implant 20 entering the guide sheath 45 and reaching the designated position in the patient's body, a small amount of air may be introduced into each sheath. This excess air can be extracted by connecting a negative pressure device (not limited to a syringe) to the first shut-off valve 612 to apply negative pressure to each sheath. Furthermore, the inner cavity of the first cylinder 611 is connected to the inner cavity of the guide sheath 45. The distal end of the guide sheath 45 is located in the designated position in the patient's body (such as the left atrium or aorta). By connecting a corresponding monitoring device (not limited to a blood pressure monitoring device) to the first shut-off valve 612, the patient's physiological parameters, such as intravascular blood pressure or the atrioventricular pressure gradient, can be monitored during the procedure, and the implantation effect of the medical implant 20 can be determined based on these physiological parameters.

[0095] It should be noted that, similar to existing guide sheaths, guide sheath 45 also has other components, such as an end cap 458 that is detachably connected (e.g., but not limited to, threaded connection) to the proximal end of guide handle 456 (see...). Figure 10 The end cap 458 has a through hole for the tube body 613 to pass through, and the O-ring is provided between the sealing gasket 451 and the transition piece 453. This will not be described in detail here.

[0096] In summary, the medical accessory 60, the medical interventional system 1, and the venting method provided in this application include a first element 61 and a second element 62 detachably connected thereto. When the first element 61 is used alone, it can be used to protect and / or load the medical implant 20. When the first element 61 and the second element 62 are assembled into a single unit, the medical accessory 60 can be used to vent air from the medical interventional system 1 containing the medical implant 20. Therefore, the medical interventional system 1 does not require separate components for the protection and loading of the medical implant 20, or for venting the entire system, resulting in a simple overall structure, convenient operation, and reduced surgical time.

[0097] In the description of this specification, the references to terms such as "some embodiments," "illustrative embodiments," "examples," "specific examples," or "some examples," etc., indicate that a specific feature, structure, material, or characteristic described in connection with that embodiment or example is included in at least one embodiment or example of this application. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples.

[0098] Although embodiments of this application have been shown and described, those skilled in the art will understand that various changes, modifications, substitutions and variations can be made to these embodiments without departing from the principles and spirit of this application, the scope of which is defined by the claims and their equivalents.

Claims

1. A medical interventional system, characterized in that, This includes medical implants, delivery devices, and medical accessories; The medical accessory includes 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, a first sealing body disposed within the first cylinder, and a first on / off valve sealingly connected to the inner cavity of the first cylinder; wherein, the first sealing body has a first inner hole, and the first cap can selectively compress the first sealing body to reduce the diameter of the first inner hole; the second element includes a second cylinder and a second on / off valve sealingly connected to the inner cavity of the second cylinder; the distal end of the first cylinder and the proximal end of the second cylinder are detachably connected, and in the connected state, the tube extends into the inner cavity of the second cylinder, and a seal is formed between the tube and the inner cavity of the second cylinder; The delivery device includes a bending sheath and a delivery sheath, the delivery sheath being movably inserted inside the bending sheath, and the distal end of the delivery sheath being detachably connected to the medical implant; wherein, the bending sheath is provided with a first exhaust valve, and the delivery sheath is provided with a second exhaust valve; In the first state, the first element is sleeved on the distal end of the bending sheath, the distal end of the bending sheath passes through the first inner hole and is held tightly by the first sealing body, the medical implant is housed in the inner cavity of the tube, and the first element functions alone to protect the medical implant. In the second state, the first element is sleeved on the distal end of the bending sheath and connected to the second element. The distal end of the bending sheath passes through the first inner hole and is held tightly by the first sealing body. The medical implant is housed in the inner cavity of the tube. The first element and the second element work together to remove air from the medical intervention system through the first on / off valve, the second on / off valve, the first exhaust valve, and the second exhaust valve.

2. The medical interventional system as described in claim 1, characterized in that, The conveying device also includes a guide sheath; In the third state, the first element is sleeved on the distal end of the bending sheath, the distal end of the bending sheath passes through the first inner hole and is held tightly by the first sealing body, and the medical implant is housed in the inner cavity of the tube body. The first element functions alone, with the tube inserted into the guide sheath, allowing the medical implant to be loaded into the guide sheath.

3. The medical interventional system as described in claim 2, characterized in that, In its natural state, the diameter of the first inner hole is equal to or greater than the outer diameter of the distal end of the bending sheath; the inner diameter of the tube body is greater than the outer diameter of the bending sheath.

4. The medical interventional system as described in claim 2, characterized in that, The guide sheath is provided with a sealing gasket and a transition piece. The sealing gasket allows the tube body to pass through and seals the outer periphery of the tube body. The transition piece is located on the distal end of the sealing gasket and is used to abut the distal end of the tube body.

5. The medical interventional system as described in claim 1, characterized in that, The minimum inner diameter of the first cylindrical body is greater than the maximum outer diameter of the medical implant, and less than or equal to the inner diameter of the tube.

6. The medical interventional system as described in claim 1, characterized in that, The first cap can rotate and / or move axially relative to the first cylinder, and compress the first sealing body in the axial and / or radial direction.

7. The medical interventional system as described in claim 6, characterized in that, The first cylinder has a stop portion on its proximal inner wall and a top abutment on its first cap; the first sealing body is housed in the proximal cavity of the first cylinder and is located between the stop portion and the top abutment.

8. The medical interventional system as described in claim 7, characterized in that, The first inner hole is a tapered hole, and the inner diameter of the tapered hole gradually decreases from its proximal end to its distal end.

9. The medical interventional system as described in claim 7, characterized in that, The outer peripheral wall of the first sealing body has a first conical surface, and the radial distance between the first conical surface and the axis of the first sealing body gradually increases from the proximal end of the first conical surface to the distal end of the first conical surface. The abutment has a second conical surface that is opposite to and adapted to the first conical surface.

10. The medical interventional system as described in any one of claims 1 or 5-9, characterized in that, The second element further includes a second cap and a second sealing body disposed in the second cylinder or the second cap, the second cap being connected to the proximal end of the second cylinder, and the second sealing body having a second inner hole; The distal end of the first cylinder is detachably connected to the proximal end of the second cap. In the connected state, the distal end of the tube passes through the second inner hole and is press-fitted with the second sealing body, so that a seal is formed between the inner cavity of the tube and the second cylinder.

11. The medical interventional system as described in claim 10, characterized in that, The distal end of the first cylinder can be detachably connected to the proximal end of the second cap by means of threaded connection or snap-fit ​​connection.

12. The air venting method of the medical interventional system as described in any one of claims 1-11, characterized in that, At least the following operations are included: The first element is sleeved on the distal end of the bending sheath and connected to the second element, so that the distal end of the bending sheath passes through the first inner hole and is held tightly by the first sealing body, and the medical implant is housed in the inner cavity of the tube body. Keep any two of the second on / off valve, the first vent valve, and the second vent valve closed, and open the remaining one together with the first on / off valve, injecting liquid into the first on / off valve until the liquid flows out from the remaining one.

13. The air venting method of the medical interventional system as described in claim 12, characterized in that, include: With the first shut-off valve, the second shut-off valve, the first exhaust valve, and the second exhaust valve all closed, the second shut-off valve is placed in the highest position, the first shut-off valve and the second shut-off valve are opened, and liquid is injected into the first shut-off valve until the liquid flows out from the second shut-off valve to expel the air in the medical accessory. With the first on / off valve, the second on / off valve, the first exhaust valve, and the second exhaust valve all closed, the first exhaust valve is placed in the highest position, the first on / off valve and the first exhaust valve are opened, and liquid is injected into the first on / off valve until the liquid flows out from the first exhaust valve to expel the air in the bending sheath. as well as With the first on / off valve, the second on / off valve, the first exhaust valve, and the second exhaust valve all closed, the second exhaust valve is placed in the highest position, the first on / off valve and the second exhaust valve are opened, and liquid is injected into the first on / off valve until the liquid flows out from the second exhaust valve to expel the air in the delivery sheath.

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