CN118203456A

CN118203456A - Protection device and medical instrument system

Info

Publication number: CN118203456A
Application number: CN202211626626.4A
Authority: CN
Inventors: 周镜明; 彭峰
Original assignee: Shenzhen Jianxin Medical Technology Co ltd
Current assignee: Shenzhen Jianxin Medical Technology Co ltd
Priority date: 2022-12-17
Filing date: 2022-12-17
Publication date: 2024-06-18

Abstract

The present invention relates to a protection device and a medical instrument system. Suitable for protecting a valve, the protection device comprising: the sleeve assembly is provided with a lumen which is used for penetrating a conveying system of the implantation instrument; the protection cover assembly can be mutually locked with the sleeve assembly, when the protection cover assembly is locked with the sleeve assembly, the protection cover assembly is provided with a containing cavity which is communicated with the lumen and used for containing the implantation instrument, and when the locking with the sleeve assembly is released, the protection cover assembly can slide along the axial direction of the sleeve assembly. The protective device always protects the valve and the conveying system in the process of conveying, storing and loading the valve into the conveying system, so that the use safety of the conveying system and the valve is improved.

Description

Protection device and medical instrument system

Technical Field

The invention relates to the technical field of medical instruments, in particular to a protection device and a medical instrument system.

Background

Interventional prostheses, such as valves, are typically implanted into the body using a delivery system, and typically, when an interventional procedure is required, the valve is loaded into the delivery system and then the delivery system is caused to implant the valve into the body. However, the valve needs to be loaded for a long time, and more devices need to be contacted in the loading process, so that bacteria and viruses are easy to infect the valve and the delivery system, the operation is influenced, and the risk of inflammation generated after the operation of a patient is increased.

Disclosure of Invention

One technical problem solved by the present invention is how to improve the safety of use of the valve.

A protective device adapted to protect an implantation instrument and a delivery system, the protective device comprising:

The cannula assembly is provided with a lumen which is used for penetrating the conveying system of the implantation instrument;

the protection cover assembly can be mutually locked with the sleeve assembly, when the protection cover assembly is locked with the sleeve assembly, the protection cover assembly is provided with a containing cavity which is communicated with the lumen and used for containing the implantation instrument, and when the protection cover assembly is unlocked from the sleeve assembly, the protection cover assembly can slide along the axial direction of the sleeve assembly.

In one embodiment, the sleeve assembly comprises a main body sleeve and a connecting sleeve, the main body sleeve comprises a fixing section and two opening and closing pieces, the two opening and closing pieces Zhang Gepian are connected with the fixing section and can be arranged at intervals to open and close each other, and when the connecting sleeve is sleeved on one end of the Zhang Gepian far away from the fixing section, the two opening and closing pieces close to form a first sliding groove in sliding fit with the protective cover assembly.

In one embodiment, the sleeve assembly comprises two opening and closing pieces, the two opening and closing pieces Zhang Gepian can be mutually opened and closed, and when the two opening and closing pieces are closed, the lumen comprises a large cylindrical cavity and a small cylindrical cavity communicated with the large cylindrical cavity, and the caliber of the large cylindrical cavity is larger than that of the small cylindrical cavity.

In one embodiment, when the two opening and closing sheets are closed, the lumen further comprises a conical cavity, the small cylindrical cavity is communicated between the large cylindrical cavity and the conical cavity, the caliber of the conical cavity is larger than or equal to that of the small cylindrical cavity, and the caliber of the conical cavity increases along the direction from the small cylindrical cavity to the conical cavity.

In one embodiment, the fixed section encloses a first cavity, when closed, two Zhang Gepian enclose a second cavity, a third cavity and a fourth cavity, the first cavity, the second cavity, the third cavity and the fourth cavity are sequentially arranged along an axial direction, the caliber of the first cavity and the caliber of the second cavity are equal, the caliber of the third cavity are smaller than the caliber of the second cavity, the caliber of the third cavity is smaller than the caliber of the fourth cavity, and the fourth cavity is smaller than the conical cavity.

In one embodiment, the fixing section is provided with a second chute extending to two ends of the fixing section, and the second chute is communicated with the first chute and is in sliding fit with the protective cover assembly.

In one embodiment, grooves are formed in the outer peripheral surfaces of the two opening and closing pieces in a recessed mode, the two grooves extend in the circumferential direction and are communicated with each other, and the protective cover assembly comprises a buckle matched with the grooves.

In one embodiment, the outer peripheral surfaces of the two opening and closing pieces are concavely provided with a clearance hole, and the clearance hole is communicated with the lumen and the first chute.

In one embodiment, the side wall surface of the clearance hole is directly connected with the side wall surface of the first chute to form an obtuse angle.

In one embodiment, the main body sleeve further comprises a boss, the boss is arranged on the outer peripheral surface of the opening and closing piece in a protruding mode, a first clamping groove and a second clamping groove which are communicated with each other are formed in the connecting sleeve, the first clamping groove extends along the axial direction, the second clamping groove extends along the circumferential direction, and the boss can be matched with the second clamping groove through the first clamping groove.

In one embodiment, a third chute which is in sliding fit with the protective cover assembly is formed in the connecting sleeve, and the third chute is communicated with the first chute and keeps a set distance from one end, far away from the fixed section, of the connecting sleeve.

In one embodiment, the connecting sleeve comprises a tightening section and a convex ring, the tightening section is sleeved on the opening and closing piece, the convex ring surrounds and protrudes to be arranged at one end, far away from the fixing section, of the tightening section, and the convex ring can be abutted with the protective cover assembly along the axial direction.

In one embodiment, the tightening section encloses a taper hole, when the connecting sleeve is sleeved on one end of the Zhang Gepian, which is far away from the fixed section, the opening and closing piece comprises a taper part, the caliber of the taper hole gradually increases along the direction from the fixed section to the opening and closing piece, and the outer diameter of the taper part gradually decreases; when the connecting sleeve is folded, the connecting sleeve and the conical part are in interference fit, and the end surfaces of the connecting sleeve and the conical part are mutually flush.

In one embodiment, the boot assembly is capable of sliding axially of the cannula assembly to radially compress the insertion instrument when unlocked from the cannula assembly.

In one embodiment, the protective cover assembly comprises a front protective cover and a rear protective cover which are detachably connected and jointly enclose the accommodating cavity, and the front protective cover is in sliding connection with the sleeve assembly when the locking with the sleeve assembly is released.

In one embodiment, the front protection cover comprises a front cover body and a protruding block, the protruding block is arranged on the outer surface of the front cover body in a protruding mode, a guide groove is formed in the inner surface of the rear protection cover in a recessed mode, and the protruding block is matched with the guide groove.

In one embodiment, the front protective cover further comprises a sliding block located in the accommodating cavity, wherein the sliding block is arranged on the inner surface of the front cover body in a protruding mode and can be connected with the sleeve assembly in a sliding mode.

In one embodiment, the front protection cover encloses into a first front cavity, a second front cavity and a third front cavity which are sequentially arranged and configured into a part of the accommodating cavity, the first front cavity and the second front cavity are both cylindrical and are provided with a step surface therebetween, the caliber of the second front cavity is larger than that of the first front cavity, the caliber of the third front cavity is larger than or equal to that of the second front cavity, the first front cavity is matched with the sleeve component, the step surface is in butt joint with the sleeve component along the axial direction, and the caliber of the third front cavity is increased along the direction pointing from the second front cavity to the third front cavity.

In one embodiment, the rear protection cover encloses and is configured as a first rear cavity and a second rear cavity of a part of the accommodating cavity, when the front protection cover is connected with the rear protection cover, the first rear cavity is further away from the front protection cover relative to the second rear cavity, the caliber of the second rear cavity is greater than or equal to that of the first rear cavity, the first rear cavity is cylindrical, and the caliber of the second rear cavity is increased along the direction from the first rear cavity to the second rear cavity.

In one embodiment, the protecting cover assembly comprises a front protecting cover and a rear protecting cover which are detachably connected and jointly enclose the accommodating cavity, the front protecting cover is provided with a front air hole communicated with the accommodating cavity, the rear protecting cover is provided with a rear air hole communicated with the accommodating cavity, and when the front protecting cover is connected with the rear protecting cover, the front air hole is aligned with the rear air hole to be communicated with each other.

A medical device system comprising an implant device and a delivery system, the medical device system further comprising a protective device according to any one of the preceding claims.

One technical effect of one embodiment of the present invention is: during the process of conveying, storing and loading the valve into the conveying system, the protecting cover assembly and the sleeve assembly always form protecting action on the valve and the conveying system, so that other appliances are prevented from contacting the far ends of the valve and the conveying system, bacteria and viruses are prevented from being infected by the valve and the conveying system, and the use safety of the conveying system and the valve is improved.

Drawings

FIG. 1 is a schematic illustration of a plan cut-away configuration of a delivery system according to one embodiment;

FIG. 2 is a schematic perspective view of a valve according to one embodiment;

FIG. 3 is an exploded view of a loading device according to one embodiment;

FIG. 4 is an exploded view of the loader assembly of the loader of FIG. 3;

FIG. 5 is a schematic perspective view of a compression member of the loading device shown in FIG. 3;

FIG. 6 is a schematic perspective view of an isolation assembly of the loader of FIG. 3;

FIG. 7 is a schematic perspective view of an isolation assembly of a loading device according to an embodiment;

FIG. 8 is a schematic plan sectional view of the isolation assembly of FIG. 7;

FIG. 9 is a schematic perspective view of an isolation assembly of a loading device according to an embodiment;

FIG. 10 is a schematic plan sectional view of the isolation assembly of FIG. 9;

FIG. 11 is a schematic perspective view of an isolation assembly of a loading device according to an embodiment;

FIG. 12 is a schematic plan sectional view of the isolation assembly of FIG. 11;

FIG. 13 is a schematic perspective view of an isolation assembly of a loading device according to an embodiment;

FIG. 14 is a schematic plan sectional view of the isolation assembly of FIG. 13;

FIG. 15 is a schematic plan sectional view of a protective device according to an embodiment;

FIG. 16 is a schematic perspective view of a sleeve assembly of the protective device of FIG. 15;

FIG. 17 is a schematic plan sectional view of the main body sleeve of the protective device of FIG. 15 when expanded;

FIG. 18 is a schematic perspective view of the main body sleeve of the protective device of FIG. 15 when opened;

FIG. 19 is a schematic view showing a perspective structure of a connecting sleeve in the protection device shown in FIG. 15;

FIG. 20 is a schematic plan sectional view of the connecting sleeve of the protective device of FIG. 15;

FIG. 21 is a schematic view of a partial plan cross-sectional structure of a front protective cover of the protective device of FIG. 15;

FIG. 22 is a schematic view of the overall plan cross-sectional structure of the front protective cover of the protective device of FIG. 15;

FIG. 23 is a schematic plan sectional view of the rear protective cover of the protective device of FIG. 15;

FIG. 24 is a schematic perspective view of a rear protective cover of the protective device of FIG. 15;

FIG. 25 is a first state diagram of the protective device and delivery system of FIG. 15 during valve preloading;

FIG. 26 is a second state diagram of the protective device and delivery system of FIG. 15 during valve preloading;

FIG. 27 is a third state diagram of the protective device and delivery system of FIG. 15 during valve preloading;

FIG. 28 is a fourth state diagram of the protective device and delivery system of FIG. 15 during valve preloading;

FIG. 29 is a fifth state diagram of the protective device and delivery system of FIG. 15 during valve preloading;

FIG. 30 is a sixth state diagram of the protective device and delivery system of FIG. 15 during valve preloading;

FIG. 31 is a view of the valve compressed by the protective device and delivery system of FIG. 15 to fully seat;

FIG. 32 is a schematic plan sectional view of a protective device according to an embodiment;

FIG. 33 is a schematic perspective view of a front protective cover of the securing apparatus shown in FIG. 32;

FIG. 34 is a schematic plan sectional view of the front protective cover of the securing apparatus shown in FIG. 32;

FIG. 35 is a schematic view showing a perspective structure of a rear protective cover in the securing apparatus shown in FIG. 32;

FIG. 36 is a schematic plan sectional view of the front and rear protective covers of the securing apparatus of FIG. 32;

FIG. 37 is a first state diagram of the protective device and delivery system of FIG. 32 during valve preloading;

FIG. 38 is a second state diagram of the protective device and delivery system of FIG. 32 during valve preloading;

FIG. 39 is a third state diagram of the protective device and delivery system of FIG. 32 during valve preloading;

FIG. 40 is a fourth state diagram of the protective device and delivery system of FIG. 32 during valve preloading;

FIG. 41 is a fifth state diagram of the protective device and delivery system of FIG. 32 during valve preloading;

FIG. 42 is a sixth state diagram of the protective device and delivery system of FIG. 32 during valve preloading;

FIG. 43 is a state diagram of the protective device and delivery system of FIG. 32 with the valve cleaned by the pump assembly;

FIG. 44 is an exploded view of a loading device according to one embodiment;

FIG. 45 is a schematic perspective view of a sleeve assembly according to one embodiment;

FIG. 46 is a schematic plan cross-sectional view of a sleeve assembly according to one embodiment;

FIG. 47 is an exploded view of the sleeve assembly of FIG. 45;

FIG. 48 is a schematic view of the structure of the folding sheet of FIG. 45;

FIG. 49 is an exploded view of a loading device according to one embodiment;

FIG. 50 is a schematic view of the loading assembly of FIG. 49;

FIG. 51 is an exploded view of the isolation assembly of FIG. 49.

Detailed Description

In order that the invention may be readily understood, a more complete description of the invention will be rendered by reference to the appended drawings. The drawings illustrate preferred embodiments of the invention. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete.

It will be understood that when an element is referred to as being "fixed to" another element, it can be directly on the other element or intervening elements may also be present. When an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. The terms "inner", "outer", "left", "right" and the like are used herein for illustrative purposes only and do not represent the only embodiment. "distal" and "proximal" are used as terms of orientation, which are terms commonly used in the art of interventional medical devices, where "distal" refers to the end of the procedure that is distal to the operator and "proximal" refers to the end of the procedure that is proximal to the operator. "axial" generally refers to the longitudinal direction of a medical device when delivered, and "radial" generally refers to the direction of the medical device perpendicular to its "axial" direction, and defines the "axial" and "radial" directions of any component of the medical device in accordance with this principle.

First embodiment

Referring to fig. 1 and 2, the loading device 30 of the present embodiment is used to compress the valve 20 to accommodate the valve 20 into the delivery system 10.

The delivery system 10 includes a delivery sheath 110 and a sheath core 120, the delivery sheath 110 may be tubular, and the sheath core 120 includes a steering section 121, a holder 122, a connecting cable 123, and a introducer 124. The manipulation section 121, the holder 122, the connecting cable 123, and the introducer 124 are sequentially arranged in the axial direction of the sheath core 120 such that the holder 122 is connected between the manipulation section 121 and the connecting cable 123, and the connecting cable 123 is connected between the connecting cable 123 and the introducer 124. The outer diameter of the handling section 121 may be larger than the outer diameter of the connecting cable 123, and the seeker 124 includes a support section 1241 and a cover section 1242, the support section 1241 being cylindrical and the cover section 1242 being tapered. From the support section 1241 toward the cover section 1242 in the axial direction of the sheath core 120, the outer diameter of the support section 1241 increases and then remains constant, and the outer diameter of the cover section 1242 gradually decreases. The cover section 1242 is disposed on the distal end surface of the support section 1241 in a protruding manner, and the support section 1241 may be inserted into the delivery lumen 111 of the delivery sheath 110, so that the support section 1241 reinforces the structural strength of the delivery sheath 110 and prevents the end of the delivery sheath 110 from deforming. The proximal end of the capping section 1242 has an outer diameter that is greater than the inner diameter of the distal port of the delivery sheath 110, so that the capping section 1242 may act as a closure to the delivery lumen 111 of the delivery sheath 110.

Both the manipulation section 121 and the connecting cable 123 may be threaded into the delivery lumen 111 of the delivery sheath 110, and the holder 122 may also be received in the delivery lumen 111 of the delivery sheath 110. When the valve 20 is received in the delivery system 10, the end of the valve 20 is detachably connected to the holder 122, the holder 122 acts as an axial stop for the valve 20, and the connecting cable 123 is threaded through the valve 20 such that the valve 20 is located between the handling section 121 and the introducer 124. The manipulation section 121 is reciprocally slidable within the delivery lumen 111 of the delivery sheath 110 to move the anchor 122 and the connecting cable 123 relative to the delivery sheath 110. When the holder 122 is positioned in the delivery lumen 111 of the delivery sheath 110, a portion of the valve 20 will be received in the delivery lumen 111 of the delivery sheath 110, and when the support section 1241 of the introducer 124 is fully positioned in the delivery lumen 111 and the cover section 1242 occludes the delivery lumen 111, the entire valve 20 will be fully received in the delivery lumen 111 of the delivery sheath 110 for implantation of the valve 20 into the body through the delivery system 10.

Referring to fig. 3,4, 5 and 6, the loading device 30 includes a loading assembly 200, an isolation assembly 300 and a pressing member 400. The loading assembly 200 includes a receiving structure including a receiving cavity 220 and a compression port in communication with the receiving cavity 220. The accommodating structure includes two or three loading portions 210, and when the number of loading portions 210 is two, the two loading portions 210 may be detachably connected and jointly enclose the accommodating cavity 220, and in other embodiments, two or more loading portions 210 may be detachably connected, for example, two or more loading portions 210 may be connected and integrally formed, or may be separately manufactured and then fixedly connected together. The loading part 210 includes a loading unit 211 and a protrusion part 212, the loading unit 211 is used to enclose a receiving cavity 220, the receiving cavity 220 may be tapered, the compressing port is directed from the compressing member 400 along the axial direction of the loading device 30, and the caliber of the receiving cavity 220 may be gradually reduced to communicate with the compressing port. The protrusion 212 is convexly provided on the outer side surface of the loading unit 211 such that the protrusion 212 protrudes a certain length in the radial direction of the loading unit 211 with respect to the loading unit 211 and is located outside the receiving chamber 220. The boss 212 defines a receptacle 2121 into which the isolation assembly 300 can be inserted to mate with the receptacle 2121. The protruding portion 212 is further provided with a first thread, and the pressing member 400 is provided with a second thread, so that the protruding portion 212 and the pressing member 400 can be connected through the first thread and the second thread.

The two loading parts 210 are respectively denoted as a first loading part and a second loading part, the first loading part further comprising a hanger 213, the hanger 213 being disposed at an end of the first loading part where the loading unit 211 is remote from the pressing member 400 such that the hanger 213 and the boss 212 are disposed at intervals in an axial direction of the loading part 210. The second loading part further includes a catching protrusion 214, and the hanging hook 213 is disposed at an end of the loading unit 211 of the second loading part, which is far away from the pressing member 400, and the catching protrusion 214 protrudes a certain length with respect to a radial direction of the loading unit 211 and is located outside the receiving cavity 220. When the two loading parts 210 are connected to each other to form the accommodating cavity 220, the locking protrusion 214 may be locked in the hook 213, so as to limit the two loading parts 210 along the axial direction and the circumferential direction of the loading parts 210, and prevent the two loading parts 210 from sliding and rotating relatively. In this embodiment, two pairs of mutually cooperating snap-tabs 214 and hooks 213 are provided in the loading assembly 200, and the two pairs of mutually cooperating snap-tabs 214 and hooks 213 are radially opposed, in other embodiments, one or more pairs of mutually cooperating snap-tabs 214 and hooks 213 may be provided in the loading assembly 200, or in other embodiments, the snap-tabs 214 and hooks 213 may be omitted.

The loading units 211 have abutment surfaces 2111, and when the two loading portions 210 are connected to each other, the two abutment surfaces 2111 on the two loading units 211 will abut against each other to form an abutment relationship. The abutment surface 2111 of the first loading portion may be provided with a counter bore 2112, and the second loading portion may further include a stopper 215, where the stopper 215 is disposed on the abutment surface 2111 in a protruding manner. When the two abutment surfaces 2111 abut each other, the stop block 215 will be inserted into the counterbore 2112 to mate with the counterbore 2112. Through the cooperation of counter bore 2112 and stopper 215, can play the effect of improving the installation accuracy, also further carry out spacing to two loading portions 210 along loading portion 210's axial and circumference, prevent that two loading portions 210 from producing relative slip and rotation. In other embodiments, the number of stop blocks 215 and counter bores 2112 may be one or more than two pairs, or in other embodiments, stop blocks 215 and counter bores 2112 may be omitted.

The loading assembly 200 includes a tip section 2113 and a connecting section 2114 in the axial direction, with both the tip section 2113 and the connecting section 2114 being coaxially disposed or not coaxially disposed, the boss 212 being disposed on the connecting section 2114, and the hanger 213 and the catch 214 being disposed on the tip section 2113. The connection section 2114 may be cylindrical and the tip section 2113 may be similarly tapered, pointing from the connection section 2114 to the tip section 2113 in the axial direction of the loading unit 211, the outer diameter of the connection section 2114 remaining constant and the outer diameter of the tip section 2113 gradually decreasing. In other embodiments, the connecting segment 2114 and the tip segment 2113 may be other shapes, for example, the connecting segment 2114 may be tapered, the tip segment 2113 may be cylindrical, or both the connecting segment 2114 and the tip segment 2113 may be cylindrical, regardless of the shape, as long as the caliber of the receiving chamber 220 may gradually decrease from the compression member 400 toward the compression port in the axial direction of the loading device 30.

In some embodiments, isolation assembly 300 is removably coupled to loading portion 210 and defines an isolation chamber 310, and receiving chamber 220 and isolation chamber 310 are in communication with one another and are configured to receive valve 20. Referring to fig. 6, the isolation assembly 300 includes an isolation plate 320, a surrounding cylinder 330, and positioning blocks 340, the surrounding cylinder 330 may be cylindrical, and an end portion of the surrounding cylinder 330 is connected to a periphery of the isolation plate 320, such that the surrounding cylinder 330 surrounds the isolation plate 320, the isolation plate 320 has an isolation surface 321, the isolation surface 321 is one surface of the isolation plate 320 in a thickness direction, the isolation surface 321 and the surrounding cylinder 330 together enclose a first limiting cavity 361, the first limiting cavity 361 is configured to form the isolation cavity 310, the number of the positioning blocks 340 may be two (in other embodiments, the number of the positioning blocks 340 may be one or more than two), the positioning blocks 340 are connected to an end of the surrounding cylinder 330 away from the isolation plate 320, and the two positioning blocks 340 are respectively inserted into insertion holes 2121 of the two protruding portions 212, so that the isolation assembly 300 may be connected to the loading assembly 200 on one hand, and the loading portion 210 may also be positioned circumferentially to prevent relative rotation. The isolation plate 320 is provided with a through hole 322, the through hole 322 communicates with the outside and the isolation cavity 310, and the sheath core 120 of the delivery system 10 can be simultaneously inserted into the isolation cavity 310 and the through hole 322, for example, one end of the through hole 322 can directly penetrate through the isolation surface 321.

Referring to fig. 7 and 8, in other embodiments, the isolation surface 321 is recessed by a certain depth to form a second spacing cavity 362, and the second spacing cavity 362 and the first spacing cavity 361 may be coaxially disposed, so that the first spacing cavity 361 and the second spacing cavity 362 are jointly configured as the isolation cavity 310, the caliber of the second spacing cavity 362 is smaller than that of the first spacing cavity 361, a bottom wall surface (a surface opposite to the surface of the second spacing cavity 362 that is open in the axial direction) of the isolation assembly 300 is spaced from the isolation surface 321 along the axial direction of the isolation assembly 300, and one end of the through hole 322 penetrates through the bottom wall surface of the second spacing cavity 362, so that the through hole 322 is directly communicated with the second spacing cavity 362.

Referring to fig. 9 and 10, in other embodiments, the isolation assembly 300 further includes a constraining cylinder 350, where the constraining cylinder 350 may also be cylindrical, the constraining cylinder 350 is convexly disposed on a bottom wall surface of the second limiting cavity 362, the constraining cylinder 350 encloses a third limiting cavity 363, the third limiting cavity 363 is coaxially disposed with the second limiting cavity 362, and the first limiting cavity 361, the second limiting cavity 362 and the third limiting cavity 363 are jointly configured as the isolation cavity 310. Obviously, the caliber of the third limiting cavity 363 is smaller than that of the second limiting cavity 362, and the bottom wall surface of the third limiting cavity 363 (the surface opposite to the opening of the third limiting cavity 363 in the axial direction) is spaced from the isolation surface 321 along the axial direction of the isolation assembly 300, and one end of the through hole 322 penetrates through the bottom wall surface of the third limiting cavity 363, so that the through hole 322 is directly communicated with the third limiting cavity 363. The end of the positioning block 340, which is far away from the surrounding barrel 330, is taken as a reference end 341, and the bottom wall surface of the third limiting cavity 363 is closer to the reference end 341 than the isolating surface 321, which can be understood as that the bottom wall surface of the third limiting cavity 363 is located above the isolating surface 321.

Referring to fig. 11 and 12, in other embodiments, the restraining barrel 350 is disposed on the isolation surface 321 in a protruding manner, the restraining barrel 350 encloses a second limiting cavity 362, and the second limiting cavity 362 is disposed coaxially with the first limiting cavity 361 and is configured as the isolation cavity 310 (refer to fig. 6). The bottom wall surface of the second spacing cavity 362 is disposed along the axial direction of the isolation assembly 300 and spaced from the isolation surface 321, and one end of the through hole 322 penetrates through the bottom wall surface of the second spacing cavity 362, so that the through hole 322 is directly communicated with the second spacing cavity 362. The bottom wall surface of the second limiting cavity 362 is closer to the reference end 341 than the isolating surface 321, which can be generally understood that the bottom wall surface of the second limiting cavity 362 is located above the isolating surface 321.

Referring to fig. 13 and 14, in other embodiments, for the restraining cylinder 350 that is convexly disposed on the isolation surface 321 and encloses the second limiting cavity 362, a third limiting cavity 363 is concavely formed on the bottom wall surface of the second limiting cavity 362 of the restraining cylinder 350, and the first limiting cavity 361, the second limiting cavity 362 and the third limiting cavity 363 are jointly configured as the isolation cavity 310 (refer to fig. 6). Obviously, the caliber of the third limiting cavity 363 is smaller than that of the second limiting cavity 362, the bottom wall surface of the third limiting cavity 363 is arranged at intervals from the isolating surface 321 along the axial direction of the isolating assembly 300, and one end of the through hole 322 penetrates through the bottom wall surface of the third limiting cavity 363, so that the through hole 322 is directly communicated with the third limiting cavity 363. The bottom wall surface of the third limiting cavity 363 is closer to the reference end 341 than the isolating surface 321, which can be generally understood as the bottom wall surface of the third limiting cavity 363 is located above the isolating surface 321.

Referring to fig. 3 and 5, in some embodiments, the compressing member 400 includes a gland 410 and a side cylinder 420, and the side cylinder 420 may be cylindrical, with one end of the side cylinder 420 connected with an edge of the gland 410 such that the side cylinder 420 is disposed around the gland 410. An internal thread is provided on the inner surface of the side barrel 420 for engagement with an external thread on the boss 212 to achieve a threaded connection of the side barrel 420 with the boss 212. The side cylinder 420 can be sleeved on the surrounding cylinder 330, the gland 410 can be stacked on the isolation plate 320 of the isolation assembly 300 along the axial direction of the loading device 30, and when the side cylinder 420 is rotated to enable the internal threads and the external threads to be meshed with each other, the gland 410 can gradually move close to the loading part 210, so that the gland 410 can apply an axial pushing force to the isolation plate 320, thereby pushing the isolation plate 320 to move close to the loading part 210, and the positioning block 340 is gradually inserted into the insertion hole 2121. The gland 410 is provided with a through hole 411, and the through hole 411 can be coaxially arranged with the through hole 322 on the isolation plate 320, so that the sheath core 120 can be simultaneously penetrated in the accommodating cavity 220, the through hole 322 and the through hole 411. After the entire loading device 30 is assembled, the isolation assembly 300 isolates the receiving chamber 220 from the isolation chamber 310, so that the receiving chamber 310 and the isolation chamber are spaced apart from the pressing member 400, and the valve 20 in the isolation chamber 310 and the receiving chamber 220 cannot contact the pressing member 400.

For convenience of description, the loading device 300 will be described by taking the example that the loading device 30 includes the isolation assembly 300 configured to form the isolation chamber 310 through only the first limiting chamber 361, i.e., the loading device 30 employs the isolation assembly 300 shown in fig. 6. When it is desired to compress the valve 20 by the loading device 30, referring to fig. 3 and 26, there may be the following operational steps:

first, the valve 20 is first sleeved outside the sheath core 120, the valve 20 is placed in the middle of the two loading parts 210, the two loading parts 210 are closed, so that the two pressing surfaces 2111 are contacted with each other, the buckle 723 on the first loading part is clamped in the hook 213 of the second loading part, the counter bore 2112 on the first loading part is matched with the limiting block 215 on the second loading part, thus the initial assembly of the loading assembly 200 is realized, the accommodating cavity 220 is formed, a part of the valve 20 is positioned in the accommodating cavity 220, and the fixer 122 on the sheath core 120 is positioned near one end with smaller caliber of the accommodating cavity 220.

In a second step, the stopper 215 of the isolation assembly 300 is inserted into the insertion hole 2121 of the boss 212 so that the valve 20 is received in the isolation cavity 310 formed by the receiving cavity 220 and the first stopper cavity 361.

Third, the side cylinder 420 of the pressing member 400 is sleeved on the surrounding cylinder 330 of the isolation assembly 300, and the side cylinder 420 is rotated so that the side cylinder 420 is screwed with the boss 212. During rotation, the gland 410 will push the spacer 320 progressively closer to the loading portion 210, such that the spacer 320 progressively pushes the valve 20 away from the end of the holder 122 progressively closer to the smaller bore end of the receiving chamber 220. In view of the conical shape of the receiving chamber 220, the loading portion 210 will radially compress the valve 20 during movement of the valve 20 relative to the receiving chamber 220, thereby reducing the outer diameter of the valve 20. In fact, the loading portion 210 mainly compresses the end of the valve 20 close to the holder 122 to interconnect the end of the valve 20 with the holder 122.

If the isolation assembly 300 were not provided, the gland 410 of the compression member 400 would directly contact the end of the valve 20 such that the gland 410 directly pushed the valve 20 to slide in the receiving chamber 220 to be compressed. When the valve 20 slides along the axial direction of the loading device 30 relative to the accommodating cavity 220, the gland 410 rotates along the radial direction of the loading device 30 relative to the valve 20, namely, the valve 20 rotates relative to the gland 410, so that a large friction force is generated between the valve 20 and the gland 410, on one hand, the valve 20 is damaged under the action of the large friction force, on the other hand, one end of the valve 20, which is contacted with the gland 410, is relatively sharp, the valve 20 is scratched relatively to the gland 410, then, the chip material which is detached from the gland 410 due to scratching is adhered to the valve 20, and the chip material enters into a blood vessel along with the valve 20 implanted in a human body, thereby embolizing the blood vessel to form harm to the human body, and the use safety of the valve 20 is affected.

With the loading device 30 in the above embodiment, the valve 20 located in the accommodating cavity 220 and the isolation cavity 310 cannot be contacted with the pressing member 400 due to the isolation action of the isolation assembly 300, so that friction between the pressing cover 410 and the valve 20 can be effectively avoided, abrasion of the valve 20 can be avoided, and generation of debris material can be effectively prevented. In fact, during the movement of the gland 410 pushing the valve 20 in the receiving chamber 220 through the isolation assembly 300, the isolation assembly 300 always moves synchronously with the valve 20, i.e. the isolation assembly 300 and the valve 20 do not move relatively, so that the abrasion between the isolation assembly 300 and the valve 20 due to friction is eliminated. Meanwhile, although the valve 20 rubs against the inner wall surface of the receiving chamber 220, the pressure between the loading part 210 and the valve 20 is small, and the friction between the valve 20 and the loading part 210 will not be enough for the valve 20 to form a lesion. Further, after the valve 20 is completely compressed, the threaded connection between the pressing member 400 and the loading portion 210 may be released, so that the pressing member 400 is unloaded; the positioning block 340 of the isolation assembly 300 is then pulled out of the receptacle 2121 to unload the isolation assembly 300; finally, the stopper 215 is disengaged from the counterbore 2112 and the catch 723 and the hook 213 are snapped to release the connection of the two loading portions 210, allowing the entire loading device 30 to be unloaded from the delivery system 10 and valve 20.

When the loading device 30 employs the isolation assembly 300 shown in fig. 7 and 8, the aperture of the second limit is smaller than that of the first limit cavity 361, and the bottom wall surface of the second limit cavity 362 is located above the isolation surface 321. In the case of compressing the valve 20, when the valve 20 is longer and the outer diameter is smaller, the end of the valve 20 may be received in the second limiting chamber 362; when the valve 20 is of a smaller length and of a larger outer diameter, the end of the valve 20 may be received in the first restraining lumen 361. Depending on the type of valve 20, the ends of the valve 20 may be received in two different restraining lumens, so the loading device 30 may be adapted to compress two different types of valves 20.

When the device employs the isolation assembly 300 shown in fig. 9 and 10, the aperture of the third spacing chamber 363 is smallest in view of the largest aperture of the first spacing chamber 361, the second spacing chamber 362 and the third spacing chamber 363, and the bottom wall surface of the third spacing chamber 363 is located above the isolation surface 321. In the case of compressing the valve 20, the end of the valve 20 may be received in the first spacing cavity 361 when the valve 20 is of moderate length and of maximum outer diameter, the end of the valve 20 may be received in the second spacing cavity 362 when the valve 20 is of moderate length and of intermediate outer diameter, and the end of the valve 20 may be received in the third spacing cavity 363 when the valve 20 is of minimum length and of minimum outer diameter. Depending on the type of valve 20, the ends of the valve 20 may be received in three different restraining lumens, so the loading device 30 may be adapted to compress three different types of valves 20.

With reference to the associated description of the spacer assembly 300 of fig. 7 and 8, the loading device 30 may be adapted to compress two different types of valves 20 when the loading device 30 employs the spacer assembly 300 of fig. 11 and 12. With reference to the associated description of the spacer assembly 300 shown in fig. 9 and 10, the loading device 30 may be adapted to compress three different types of valves 20 when the loading device 30 employs the spacer assembly 300 shown in fig. 13 and 14.

The first limiting cavity 361, the second limiting cavity 362 and the third limiting cavity 363 can radially limit the valve 20 during the process of compressing the valve 20 by the loading device 30, so as to reduce the risk of deformation caused by radial expansion of the uncompressed end of the valve 20 when one end is compressed.

Second embodiment

Referring to fig. 15, the protection device 40a provided by the second embodiment can be used to protect the delivery system 10 and the valve 20, and is suitable for use with a "dry valve" valve 20, so as to reduce the risk of damage to the delivery system 10 during loading of the valve 20 into the delivery system 10, and further to avoid contamination or damage to the valve 20 during transportation and storage. The second embodiment provides a protective device 40a comprising a sleeve assembly 401 and a protective cover assembly 402, the sleeve assembly 401 comprising a body sleeve 500 and a connection sleeve 600; the boot assembly 402 includes a front boot 700 and a rear boot 800.

Referring to fig. 15, 16, 17 and 18, in some examples, the body sleeve 500 includes a fixed section 510 and two expansion pieces 520, one end of each of the two expansion pieces 520 being connected to the fixed section 510, and the other ends of the two expansion pieces 520 being capable of opening and closing with each other. The fixing section 510 may be a cylindrical tubular structure, and the fixing section 510 may be a circumferential closed structure, so that the fixing section 510 does not have a closed state and an open state, and in other embodiments, the fixing section 510 may not be a circumferential closed structure, so long as the fixing section can serve to connect one ends of the two folding pieces 520. When the two folding pieces 520 are folded, the two folding pieces 520 that are folded with each other may be spliced to form a tubular structure, and a main body portion of the tubular structure may be cylindrical or any other suitable shape. The stent-graft 520 may be elastically coupled to the fixed segment 510 such that when a pressing force is applied to the stent-graft 520 in a radial direction of the main body sheath 500, the stent-graft 520 is closed to each other to be in a closed state, and when the pressing force is gradually reduced until the stent-graft is completely withdrawn, a distance between the stent-graft 520 is gradually increased until the stent-graft is maximized to be in a completely opened state. In other examples, two stent-graft sheets 520 may be joined to form a tubular structure identical to the anchor segment 510, the tubular structure and anchor segment 510 also not having an open and closed state-changing relationship.

The cannula assembly 401 includes a coaxially disposed large cylindrical lumen 4011, a small cylindrical lumen 4012, and a tapered lumen 4013. The large cylindrical cavity 4011, the small cylindrical cavity 4012 and the conical cavity 4013 are configured as a pipe cavity 4014 of the sleeve component 401, the small cylindrical cavity 4012 is communicated between the large cylindrical cavity 4011 and the conical cavity 4013, the diameters of the large cylindrical cavity 4011 and the small cylindrical cavity 4012 are uniformly arranged along the axial direction of the sleeve component 401, the diameters of the conical cavity 4013 are unevenly arranged, the diameter of the large cylindrical cavity 4011 is larger than the diameter of the small cylindrical cavity 4012, the diameter of the conical cavity 4013 is larger than or equal to the diameter of the small cylindrical cavity 4012, the diameter of the conical cavity 4013 is increased along the axial direction of the sleeve component 401 from the small cylindrical cavity 4012 to the conical cavity 4013.

The fixing section 510 includes a first cavity 511, and when in a closed state, the two opening-closing sheets 520 include a second cavity 522, a third cavity 523 and a fourth cavity 524, and the first cavity 511, the second cavity 522, the third cavity 523 and the fourth cavity 524 are sequentially arranged along the axial direction of the main body sleeve 500, and two ends of the lumen 4014 are respectively located on the first cavity 511 and the fourth cavity 524. The first chamber 511 and the second chamber 522 have the same caliber and are both configured as the above-described large cylindrical chamber 4011, the third chamber 523 is smaller than the caliber of the second chamber 522 and is configured as the above-described small cylindrical chamber 4012, and the fourth chamber 524 is configured as the above-described tapered chamber 4013.

In view of the fact that the apertures of both the first cavity 511 and the second cavity 522 are substantially equal, such that the inner wall surfaces of both the first cavity 511 and the second cavity 522 are substantially flush with each other, the aperture of the third cavity 523 is smaller than the aperture of the second cavity 522, such that the inner wall surfaces of the third cavity 523 and the second cavity 522 are not flush, and such that the opening-closing sheet 520 has a first stop surface 525 located between the second cavity 522 and the third cavity 523, for the delivery sheath 110 penetrating into the first cavity 511 and the second cavity 522, when the end of the delivery sheath 110 abuts against the first stop surface 525, the delivery sheath 110 will stop sliding close to the third cavity 523, such that the delivery sheath 110 cannot enter into the third cavity 523, and the first stop surface 525 will play a limiting role on the movement of the delivery sheath 110, ensuring that the delivery sheath 110 can only penetrate into the first cavity 511 and the second cavity 522. Of course, for the sheath core 120 to be threaded in the delivery lumen 111 of the delivery sheath 110, the sheath core 120 may be threaded in the first lumen 511, the second lumen 522, the third lumen 523, and the fourth lumen 524 simultaneously. The caliber of the delivery lumen 111 of the delivery sheath 110 may be equal to the caliber of the third lumen 523, when the end of the delivery sheath 110 abuts against the first stop surface 525, the inner wall surfaces of the delivery lumen 111 and the third lumen 523 are substantially flush, and in the process that the sheath core 120 drives the holder 122 to enter the delivery lumen 111, the valve 20 with the end connected with the holder 122 is prevented from contacting with the distal end surface and the outer wall of the delivery sheath 110, so as to avoid the resistance of the distal end of the delivery sheath 110 to the valve 20 in motion, and the valve 20 end hooks the distal end of the delivery sheath 110 to cause damage and sheath insertion failure of the delivery sheath 110, so that the valve 20 can be ensured to enter the delivery lumen 111 smoothly, and the damage probability of the delivery sheath 110 can be reduced.

In view of the fact that the fourth chamber 524 is tapered in a horn shape, the caliber of the end of the fourth chamber 524 that is in direct communication with the third chamber 523 is substantially equal to the caliber of the third chamber 523, and the caliber of the other portion of the fourth chamber 524 is larger than the caliber of the third chamber 523. In the process that the sheath core 120 drives the valve 20 to slide so that the valve 20 enters the fourth cavity 524, the fourth cavity 524 can form a progressive compression effect on the valve 20, so that the friction resistance of the valve 20 entering the third cavity 523 is reasonably reduced, and the valve 20 is prevented from being damaged under the condition of overlarge friction resistance.

When the two opening and closing pieces 520 are closed, a first slide groove 521 is formed between the two opening and closing pieces 520, the first slide groove 521 extends along the axial direction of the main body sleeve 500, and the first slide groove 521 may be formed at a position where the two opening and closing pieces 520 are closed and opened to each other. In other words, for the tubular structure formed by splicing the two folded Zhang Gepian s 520, the first chute 521 is formed by a recess set depth on the outer peripheral surface of the tubular structure, and the depth of the recess is smaller than the thickness of the folding piece 520, so that the first chute 521 is not communicated with the second chamber 522, the third chamber 523 and the fourth chamber 524. For example, the number of first slide grooves 521 may be two, and the two first slide grooves 521 may be spaced apart 180 ° in the circumferential direction of the main body sleeve 500. As another example, the number of first runners 521 may be one or two or more, and the plurality of first runners 521 may be uniformly spaced apart in the circumferential direction of the body sleeve 500. The fixed section 510 is provided with a second sliding groove 512, the second sliding groove 512 extends along the axial direction of the main body sleeve 500, and the second sliding groove 512 extends to two ends of the fixed section 510. The second sliding groove 512 is formed by a recess of a set depth of the outer circumferential surface of the fixed section 510, the depth of the recess being smaller than the thickness of the fixed section 510, so that the second sliding groove 512 is a blind groove that does not communicate with the first cavity 511. The number of the second sliding grooves 512 is equal to that of the first sliding grooves 521, the first sliding grooves 521 and the second sliding grooves 512 form a one-to-one correspondence, and the first sliding grooves 521 and the second sliding grooves 512 are communicated with each other. The first runner 521 and the second runner 512 are each adapted to slidably mate with the front boot 700.

Grooves 526 are concavely formed on the outer circumferential surfaces of the two opening and closing pieces 520, and the two grooves 526 extend in the circumferential direction of the main body sleeve 500, so that the ends of the two grooves 526 are communicated with each other, and the two grooves 526 are ensured to form a mutually abutting relationship. In other words, for the tubular structure formed by splicing the two folded Zhang Gepian s 520, the groove 526 is formed by recessing the outer circumferential surface of the tubular structure by a set depth, and the depth of the recessing is smaller than the thickness of the folding piece 520, so that the groove 526 is not communicated with the lumen 4014 of the main body sleeve 500. The groove 526 is configured to cooperate with the front protective cover 700 such that the front protective cover 700 and the snap tab 520 form a snap-fit relationship, thereby limiting sliding movement of the front protective cover 700 relative to the body sleeve 500.

The outer peripheral surfaces of the two opening and closing sheets 520 are also concavely provided with a clearance hole 527, and the depth of the recess of the outer peripheral surfaces is equal to the thickness of the opening and closing sheets 520, so that the clearance hole 527 is communicated with the second cavity 522, and meanwhile, the clearance hole 527 is also communicated with the first chute 521. By providing the clearance holes 527, the two opening and closing pieces 520 are easy to elastically deform in the opening and closing process, so that the opening and closing pieces 520 can be opened or closed quickly. The side wall surface of the clearance hole 527 is directly connected with the side wall surface of the first chute 521, and the two side wall surfaces can be connected to form an obtuse angle.

Zhang Gepian 520 further includes a tapered portion 528, and an end of the opening and closing sheet 520 that is disposed away from the fixing section 510 is located at the tapered portion 528, so that one end of the tapered portion 528 is an end of the entire opening and closing sheet 520. When the two tabs 520 are fully closed, the two tapered portions 528 may be spliced to form a tapered tubular structure. The outer diameter of the tapered portion 528 may gradually decrease in the direction from the fixed segment 510 toward the stent-graft 520 along the axial direction of the entire body sleeve 500, i.e., the outer diameter of the tapered portion 528 near the end of the fixed segment 510 is greatest and the outer diameter of the tapered portion 528 far from the end of the fixed segment 510 is smallest. The taper 528 is for insertion into the connection sleeve 600.

The main body sleeve 500 further includes bosses 529, the number of bosses 529 may be two, the bosses 529 being protrusively provided on the outer circumferential surface of the tapered portion 528 such that the bosses 529 protrude a certain length in the radial direction of the main body sleeve 500 with respect to the outer circumferential surface of the tapered portion 528. The two ribs may be spaced circumferentially about the body sleeve 500 and the two bosses 529 may be spaced 180 apart. The boss 529 is for engagement with the connection sleeve 600 to position the connection sleeve 600 in the circumferential direction of the body sleeve 500.

Referring to fig. 15, 16, 19 and 20, in some examples, the connection sleeve 600 includes a tightening section 610 and a convex ring 620, the tightening section 610 is sleeved on the tapered portion 528 of the opening and closing piece 520, the convex ring 620 is disposed around the tightening section 610, and the convex ring 620 is disposed at one end of the tightening section 610 such that the convex ring 620 protrudes a certain length along a radial direction of the tightening section 610 relative to the tightening section 610, in other words, an outer diameter of the convex ring 620 is larger than an outer diameter of the tightening section 610. With reference to the tightening segment 610 being sleeved on the tapered portion 528, the collar 620 is disposed on an end of the tightening segment 610 remote from the fixed segment 510. The collar 620 is configured to abut the front boot 700 to limit the front boot 700 in the axial direction of the body sleeve 500.

The tightening segment 610 encloses the tapered hole 614, and the diameter of the tapered hole 614 gradually decreases from the axial direction of the main body sleeve 500 to the direction of the opening and closing piece 520 from the fixing segment 510, with reference to the sleeving of the tightening segment 610 on the tapered portion 528, so that the diameter of the tapered hole 614 near the end of the fixing segment 510 is the largest, and the diameter of the tapered hole 614 far from the end of the fixing segment 510 is the smallest. In the process of mounting the connection sleeve 600 to the main body sleeve 500, first, the end of the tapered portion 528 having the smallest outer diameter is inserted into the end of the tapered hole 614 having the largest caliber, so that the tapered portion 528 can smoothly enter into the tapered hole 614; then, the taper 528 is gradually inserted into the taper 614 such that the greater the length of the portion of the taper 528 located in the taper 614; finally, when the end with the smallest outer diameter of the tapered portion 528 reaches the end with the smallest diameter of the tapered hole 614, the end with the largest outer diameter of the tapered portion 528 forms an interference fit with the end with the largest diameter of the tapered hole 614, so that the end surface of the connecting sleeve 600, which is far away from the fixed section 510, is substantially flush with the end surface of the tapered portion 528, which is far away from the fixed section 510.

The tightening section 610 is provided with a first clamping groove 611 and a second clamping groove 612, and the first clamping groove 611 and the second clamping groove 612 are mutually communicated. The first clamping groove 611 and the second clamping groove 612 penetrate through the outer surface and the inner surface of the tightening section 610, so that the first clamping groove 611 and the second clamping groove 612 are communicated with the taper hole 614, the first clamping groove 611 extends along the axial direction of the connecting sleeve 600, one end of the first clamping groove 611 extends to the end with the largest caliber of the taper hole 614, and the other end of the first clamping groove 611 keeps a certain distance with the end with the smallest caliber of the taper hole 614 and the convex ring 620. The second clamping groove 612 extends a certain length in the circumferential direction of the connection sleeve 600, and the segment ends of the first clamping groove 611 and the second clamping groove 612 are butted and communicated with each other, so that the first clamping groove 611 and the second clamping groove 612 generally form one L-shaped groove. During installation of the connection sleeve 600 onto the body sleeve 500, when the tapered portion 528 is inserted into the tapered bore 614 by a certain length, the connection sleeve 600 is rotated by a certain angle relative to the tapered portion 528, and then the boss 529 on the tapered portion 528 enters the first clamping groove 611; continuing to insert the tapered portion 528 into the tapered hole 614, the boss 529 moves relative to the first clamping groove 611, and when the boss 529 reaches the communication position between the first clamping groove 611 and the second clamping groove 612, the connecting sleeve 600 is rotated by a certain angle relative to the tapered portion 528 again, so that the boss 529 reaches one end of the second clamping groove 612 away from the first clamping groove 611, at this time, the connecting sleeve 600 cannot rotate relative to the tapered portion 528 continuously, and the end with the largest outer diameter of the tapered portion 528 and the end with the largest caliber of the tapered hole 614 form interference fit. In other examples, boss 529, first and second detents 611 and 612 may not be provided, such that connection sleeve 600 is threadably coupled to taper 528.

Therefore, by the engagement of the boss 529 with the second catching groove 612, on one hand, the coupling sleeve 600 can be positioned in the circumferential direction of the coupling sleeve 600, preventing the coupling sleeve 600 from rotating in a specific direction relative to the tapered portion 528, and on the other hand, the tight tube can be positioned in the axial direction of the coupling sleeve 600, preventing the coupling sleeve 600 from moving in the axial direction of the coupling sleeve 600 relative to the tapered portion 528, so that the boss 529 performs double positioning of the coupling sleeve 600 in the axial and circumferential directions. Further, the interference fit of taper 528 with taper 614 may also provide a degree of dual axial and circumferential positioning of connection sleeve 600. Meanwhile, in the process of gradually inserting the tapered portion 528 into the tapered hole 614, the two opening and closing pieces 520 are gradually close under the action of the connecting sleeve 600, when the end with the largest outer diameter of the tapered portion 528 and the end with the largest caliber of the tapered hole 614 form interference fit, the two opening and closing pieces 520 are in a fully closed state, under the action of the mutual fit of the boss 529 and the second clamping groove 612, the stability and reliability of the closed state of the opening and closing pieces 520 can be improved, and the connecting sleeve 600 is prevented from moving relative to the opening and closing pieces 520 under the action of smaller external force, so that the closed state of the opening and closing pieces 520 is damaged.

The tightening section 610 is further provided with third sliding grooves 613, the third sliding grooves 613 extend along the axial direction of the tightening section 610, and the number of the third sliding grooves 613 is equal to that of the second sliding grooves 512, so that the third sliding grooves 613 and the second sliding grooves 512 form a one-to-one correspondence, and the third sliding grooves 613 and the second sliding grooves 512 are mutually communicated. The third sliding groove 613 is formed by a set depth of recess of the outer circumferential surface of the tightening section 610, which is smaller than the thickness of the tightening section 610, so that the third sliding groove 613 is not communicated with the tapered hole 614, and the third sliding groove 613 is spaced from the first clamping groove 611 and the second clamping groove 612 by a certain distance along the circumferential direction of the tightening section 610. One end of the third sliding groove 613 extends to one end of the connection sleeve 600 away from the convex ring 620, and the other end of the third sliding groove 613 is spaced apart from the convex ring 620. When the adapter sleeve 600 is mounted to the main body sleeve 500, the first slide groove 521, the second slide groove 512 and the third slide groove 613 are communicated with each other and are positioned on the same line, and together form a groove structure in sliding fit with the front protection cover 700.

Both the front protective cover 700 and the rear protective cover 800 are detachably connected and together enclose a receiving chamber 4021, which receiving chamber 4021 can be used to receive the valve 20 such that the entire protective cover assembly 402 provides protection to the valve 20.

Referring to fig. 21 and 22, in some examples, the front boot 700 includes a front boot body 710, a tab 721, a slider 722, and a catch 723. The front cover 710 encloses a first front chamber 711, a second front chamber 712, a third front chamber 713, and a fourth front chamber 714, which are arranged in this order in the axial direction of the front cover 710, and the first front chamber 711, the second front chamber 712, the third front chamber 713, and the fourth front chamber 714 are configured as a part of the above-described housing chamber 4021. The first front chamber 711 and the fourth front chamber 714 are disposed near both ends of the front cover 710. The first front chamber 711, the second front chamber 712 and the fourth front chamber 714 are cylindrical chambers, and the diameters of the three chambers are all constant and uniformly arranged along the axial direction of the front cover 710. The third front cavity 713 is tapered, so that the caliber of the third front cavity 713 is unevenly arranged along the axial direction of the front cover 710, the caliber of the third front cavity 713 is gradually increased along the axial direction of the front cover 710 from the second front cavity 712 to the third front cavity 713, so that the caliber of one end of the third front cavity 713 near the second front cavity 712 is equal to the caliber of the second front cavity 712, and the calibers of other parts of the third front cavity 713 are all larger than the caliber of the second front cavity 712. The caliber of one end of the third front cavity 713 near the fourth front cavity 714 is equal to the caliber of the fourth front cavity 714, and the caliber of other parts of the third front cavity 713 is smaller than the caliber of the fourth front cavity 714. The apertures of the portions of the second front cavity 712 are all larger than the apertures of the first front cavity 711, so that the front protective cover 700 has a step surface 715 between the first front cavity 711 and the second front cavity 712, and the step surface 715 can abut against the convex ring 620 on the connecting sleeve 600, thereby limiting the sliding movement of the front protective cover 700 relative to the entire sleeve assembly 401.

A slider 722 may be disposed on an inner wall surface of the first front chamber 711, the slider 722 protruding a certain length in a radial direction of the first front chamber 711 with respect to the inner wall surface such that the slider 722 is disposed in the first front chamber 711, the slider 722 being adapted to be in sliding engagement with the first slide groove 521, the second slide groove 512 and the third slide groove 613, thereby preventing the front protection cover 700 from sliding with respect to the sleeve assembly 401 in a circumferential direction; in addition, relative movement between the front boot 700 and the ferrule assembly 401 in the circumferential direction is prevented. The portion of the front housing 710 that encloses the fourth front cavity 714 may be cylindrical. The boss 721 may be provided protruding on the outer surface of the front cover 710 for enclosing part of the fourth front cavity 714, the boss 721 being for cooperation with the rear protection cover 800. The front cover 710 may further be provided with a front air hole 716 on a portion surrounding the fourth front cavity 714, the front air hole 716 is communicated with the fourth front cavity 714, and the front air hole 716 is used for introducing sterilizing gas into the accommodating cavity 4021. The clasp 723 is connected to the end of the front housing 710 that encloses the portion of the first front cavity 711, and the clasp 723 is adapted to cooperate with the groove 526 on the tab 520 to form a snap-fit connection, thereby providing a limit to the sliding movement of the front boot 700 relative to the main body sleeve 500. The outer diameter of the delivery sheath 110 is smaller than the bore of the primary anterior chamber 711 so that the delivery sheath 110 may be threaded into the primary anterior chamber 711, and obviously the entire delivery system 10 may also be threaded into the secondary anterior chamber 712, the tertiary anterior chamber 713 and the quaternary anterior chamber 714.

Referring to fig. 23 and 24, in some examples, the rear protective cover 800 encloses a first rear chamber 810, a second rear chamber 820, and a third rear chamber 830 that are sequentially arranged in an axial direction of the rear protective cover 800, and the first rear chamber 810 and the second rear chamber 820 may be configured as a part of the above-described accommodating chamber 4021 such that the first front chamber 711, the second front chamber 712, the third front chamber 713, the fourth front chamber 714, the first rear chamber 810, and the second rear chamber 820 collectively form the accommodating chamber 4021. The first rear chamber 810 is further away from the front protection cover 700 than the second rear chamber 820, and the first rear chamber 810 and the third rear chamber 830 are each cylindrical, so that the calibers of the first rear chamber 810 and the third rear chamber 830 are maintained to be constantly and uniformly arranged along the axial direction of the rear protection cover 800. The second rear cavity 820 is tapered, so that the caliber of the second rear cavity 820 is unevenly arranged along the axial direction of the rear protection cover 800, the caliber of the second rear cavity 820 gradually increases along the axial direction of the rear protection cover 800 from the first rear cavity 810 to the second rear cavity 820, and the caliber of one end of the second rear cavity 820 close to the first rear cavity 810 is equal to the caliber of the first rear cavity 810, and the calibers of other parts of the second rear cavity 820 are all larger than the caliber of the first rear cavity 810; the caliber of one end of the second rear cavity 820 close to the third rear cavity 830 is equal to the caliber of the third rear cavity 830, and the caliber of other parts of the second rear cavity 820 is smaller than the caliber of the third rear cavity 830. The part of the front cover 710 for enclosing the fourth chamber 524 may be inserted into the third rear chamber 830, and the guide groove 841 is concavely formed on the inner wall surface of the third rear chamber 830, and when the front cover 710 is inserted into the third rear chamber 830, the protrusion 721 on the front protection cover 700 will cooperate with the guide groove 841 on the rear protection cover 800, thereby mainly preventing rotation between the rear protection cover 800 and the front protection cover, and improving the connection stability of the front protection cover 700 and the rear protection cover 800. In other embodiments, the front protection cover 700 and the rear protection cover 800 may be cooperatively connected in other manners, for example, the front protection cover 700 may be sleeved outside the rear protection cover 800, the bump 721 may be disposed on the rear protection cover 800, the guide slot 841 may be disposed on the front protection cover 700, and the bump 721 and the guide slot 841 may also be capable of realizing connection between the front protection cover 700 and the rear protection cover 800; as another example, the front protective cover 700 and the rear protective cover 800 may be detachably connected by a threaded connection or the like.

The portion of the rear protection cover 800 used for enclosing the third rear cavity 830 may also be cylindrical, where a rear air hole 842 is formed on the portion, where the rear air hole 842 is communicated with the third rear cavity 830, and the number of the rear air holes 842 and the number of the front air holes 716 may be equal, and the two may form a one-to-one correspondence relation, in other embodiments, the number of the rear air holes 842 and the number of the front air holes 716 may be unequal, and the front air holes 716 may be disposed at any other position of the front protection cover 700, and the rear air holes 842 may also be disposed at any other position of the rear protection cover 800, so long as the communication with the accommodating cavity 4021 can be achieved. When the rear and front shields 800, 700 are connected to each other, the rear and front air holes 842, 716 are radially aligned with each other such that the rear and front air holes 842, 716 communicate with each other, which in turn causes the rear and front air holes 842, 716 to both communicate with the receiving chamber 4021. When the sterilizing gas is introduced into the receiving chamber 4021 through the rear air hole 842 and the front air hole 716, the sterilizing gas can sterilize the valve 20 positioned in the receiving chamber 4021 to realize sterilization.

In the use process of the protection device 40a provided in this second embodiment, the following steps mainly exist:

Referring to fig. 25, in a first step, the entire delivery system 10 is threaded into the first, second, third and fourth front lumens 711, 712, 713 and 714 of the front protective cover 700, and the delivery sheath 110 is threaded into the lumen 4014 of the body sleeve 500 such that the distal end of the delivery sheath 110 abuts the first stop surface 525 of the body sleeve 500, thereby axially positioning the delivery sheath 110 such that the delivery sheath 110 is threaded into the first and second lumens 511, 522, and the sheath core 120 is threaded into the delivery lumen 111 of the delivery sheath 110 such that the manipulation section 121 and delivery lumen 111 are mated, and the sheath core 120 is also threaded into the third and fourth lumens 523, 524 of the body sleeve 500, exposing the anchor 122 outside the lumen 4014 of the body sleeve 500, and the end of the body sleeve 500 distal from the front protective cover 700 is located between the anchor 122 and the front protective cover 700. The connection sleeve 600 is then threaded over the tapered portion 528 (see fig. 18) of the tab 520, and the connection sleeve 600 is in an interference fit relationship with the tapered portion 528 such that the two tabs 520 are fully closed. By the engagement of the boss 529 with the second engaging groove 612 (see fig. 18 and 19), the coupling sleeve 600 can be positioned axially and circumferentially, and the third sliding groove 613 and the second sliding groove 512 can be aligned with each other in the circumferential direction, so that the third sliding groove 613 and the second sliding groove 512 are engaged and communicate with each other.

Through setting Zhang Gepian and connecting sleeve 600, in the process of threading delivery system 10 into lumen 4014, opening and closing piece 520 can be in an open state, so that large friction resistance generated between introducer 124 of sheath core 120 and the inner wall surface of third lumen 523 is avoided, friction resistance generated in the threading process of delivery system 10 is reduced, delivery system 10 is ensured to be fast threaded into lumen 4014, and abrasion generated in the threading process of delivery sheath 110 is also avoided.

Referring to fig. 26, in a second step, the loading device 30 is sleeved outside the valve 20, the end of the valve 20 to be compressed is close to the holder 122, the valve 20 is located in the accommodating cavity 220 and the isolation cavity 310 (refer to fig. 3-6), the sheath core 120 is simultaneously inserted into the isolation cavity 310 and the through hole 322, and the guide head 124 is inserted out of the through hole 322 and is located at the axial end of the through hole 322 far away from the holder 122; the loading device 30 is operated to compress the valve 20 at an end adjacent the holder 122, with the compressed end of the valve 20 extending from the opening of the loading assembly 200 at an end adjacent the holder 122, and when the valve 20 is compressed to a desired size at the end, the compressed end of the valve 20 is connected to the holder 122.

Referring to fig. 27, in a third step, the delivery system 10 is actuated such that the delivery sheath 110 and the entire sleeve assembly 401 are moved toward the loading device 30, and when the loading device 30 abuts the end of the sleeve assembly 401, a portion of the holder 122 and valve 20 will enter the third lumen 523 and the fourth lumen 524. In other embodiments, the delivery sheath 110 and cannula assembly 401 may also be held stationary, but rather the sheath core 120 is pulled proximally relative to the cannula assembly 401.

In view of the tapered shape of the fourth chamber 524, the inner wall surface of the fourth chamber 524 may provide a good guide for the retainer 122 during the process of the retainer 122 entering the fourth chamber 524 and the third chamber 523, thereby reducing friction and collision resistance of the retainer 122 entering the lumen 4014, reducing abrasion of the retainer 122, and also allowing the retainer 122 to smoothly enter the lumen 4014.

Referring to fig. 28, in a fourth step, the loading device 30 is unloaded from the sheath core 120, and the handling section 121 of the sheath core 120 is pulled, such that the holder 122 enters the delivery lumen 111 of the delivery sheath 110, which in turn causes a portion of the valve 20 to be received in the delivery lumen 111 as well.

In view of the tapered shape of the fourth lumen 524, during the process of the retainer 122 entering the fourth lumen 524, the third lumen 523 and the delivery lumen 111, the inner wall surface of the fourth lumen 524 may perform a good guiding and pre-compression function for the valve 20, reducing friction and collision resistance of the valve 20 into the lumen 4014 and the delivery lumen 111, so that the valve 20 smoothly enters the lumen 4014 and the delivery lumen 111.

Referring to fig. 29, in a fifth step, the front protection cover 700 is moved close to the connection sleeve 600, and during the movement of the front protection cover 700 close to the connection sleeve 600, the slider 722 of the front protection cover 700 is first engaged with the second sliding groove 512, then enters the first sliding groove 521 from the second sliding groove 512, and then enters the third sliding groove 613 from the first sliding groove 521 (refer to fig. 16). When the step surface 715 of the front protection cover 700 abuts against the convex ring 620 of the connection sleeve 600, the front protection cover 700 stops moving continuously, at this time, the buckle 723 on the front protection cover 700 cooperates with the groove 526 on the opening and closing piece 520 to form a clamping relationship, and the slide block 722 is located in the first slide groove 521 and the third slide groove 613 at the same time, so that the slide block 722 further limits the connection sleeve 600 in the circumferential direction, and the connection sleeve 600 is prevented from rotating relative to the main body sleeve 500. A portion of the valve 20 is located within the delivery lumen 111 and lumen 4014 (see fig. 15), another portion of the valve 20 is located within the second and third anterior lumens 712 and 713 of the anterior boot 700, and the other portion may also be located within the fourth anterior lumen 714.

In view of the fact that the side wall surface of the clearance hole 527 is directly connected with the side wall surface of the first chute 521 to form an obtuse angle α, so that the clearance hole 527 forms a shape with a large middle and a small two ends (i.e., an axial middle area is wider and two axial ends are narrower), during the sliding process of the sliding block 722 in the first chute 521, when the sliding block 722 passes through the clearance hole 527, the side wall of the clearance hole 527 plays a good guiding role facing the sliding block 722, so that the sliding block 722 is prevented from deviating from a sliding track defined by the first chute 521, the sliding block 722 is ensured to be always matched with the first chute 521, and the shaking or jamming phenomenon generated during the sliding process of the whole front protection cover 700 relative to the sleeve assembly 401 is avoided.

Referring to fig. 30, in a sixth step, the portion of the front protective cover 700 for enclosing the fourth front cavity 714 is engaged with the third rear cavity 830 of the rear protective cover 800, and the protrusion 721 on the front protective cover 700 is engaged with the guide groove 841 on the rear protective cover 800 (refer to fig. 22 and 23), so that the connection relationship between the front protective cover 700 and the rear protective cover 800 can be realized, so that the two enclose the accommodating cavity 4021. The valve 20 will be received within the delivery lumen 111, lumen 4014 and receiving lumen 4021, so the sleeve assembly 401 and the protective cap assembly 402 will provide good protection for the valve 20, with the delivery system 10 pre-loading or semi-loading the valve 20, i.e., the valve 20 is in a pre-loaded or semi-loaded state with respect to the delivery system 10, given that a portion of the valve 20 is located within the delivery lumen 111 and another portion is located outside of the delivery lumen 111. Also, a portion of the delivery sheath 110 will be received in lumen 4014 of cannula assembly 401 such that cannula assembly 401 protects delivery sheath 110. The housing lumen 4021 is then passed through the anterior and posterior vents 716, 842 with a sterilizing gas that will sterilize the valve 20 in the housing lumen 4021, lumen 4014 and delivery lumen 111 to effect a sterilization process. After sterilization of the valve 20, the entire protective device 40a, delivery system 10 and valve 20 may be packaged as a unitary kit for shipping and storage, and the protective device 40a will always provide protection to the delivery system 10 and valve 20 during shipping and storage to prevent damage to or contamination by viruses from the delivery system 10 and valve 20.

Referring to fig. 31, before a procedure is required, the protective device 40a, delivery system 10 and valve 20 as a packaged device may be removed, the snap 723 and groove 526 disengaged, and the entire protective cover assembly 402 moved closer to the fixed segment 510 of the body sleeve 500, e.g., such that the slider 722 slides out of the third and first runners 613, 521 into the second runner 512. During movement of the rear boot 800 toward the fixed segment 510, the sheath core 120 will gradually penetrate into the first rear lumen 810. In view of the tapered shape of the second rear chamber 820, the second rear chamber 820 will compress and guide the valve 20 such that the compressed valve 20 will smoothly enter the first rear chamber 810. Finally, the manipulation section 121 is pulled at a reasonable rate so that the valve 20 compressed in the first rear lumen 810 smoothly enters the delivery lumen 111 of the delivery sheath 110 so that the entire valve 20 will be fully compressed and housed in the delivery lumen 111, at which point the valve 20 is in a fully loaded state relative to the delivery system 10. In general, the delivery system 10 may be configured to implant the valve 20 in a fully loaded state into the body during surgery.

If the mode of independent transport and storage of the delivery system 10 and the valve 20 is adopted, the valve 20 needs to be fully loaded into the delivery lumen 111 of the delivery system 10 before the operation is performed, so that the valve 20 is in a fully loaded state, which on the one hand will take a long time to load the valve 20, thereby affecting the timing of the operation. On the other hand, the instruments used during loading will cause bacterial or viral infection to the valve 20 and delivery system 10, affecting the safety of the procedure. Again, if a mode is employed in which the entire valve 20 is fully received and loaded into the delivery system 10 for shipping and storage, although reloading of the valve 20 is not required prior to surgery, the valve 20 will be plastically deformed or damaged due to the valve 20 being compressed within the delivery system 10 for a long period of time, thereby affecting the normal function and service life of the valve 20.

With the protection device 40a in the second embodiment, the protection device 40a can make the valve 20 in the half-loading state, and before the operation, the valve 20 in the half-loading state is converted into the full-loading state, so that on one hand, the loading time of the valve 20 can be greatly reduced, and the operation can be performed in a timely manner, so that the patient can be quickly rescued. On the other hand, the protection device 40a protects the valve 20 which is sterilized, and the protection device 40a can convert the valve 20 into a fully loaded state, so that bacterial and viral infections of the valve 20 and the delivery system 10 caused by other auxiliary devices used in the loading process are avoided, and the safety of the valve 20 and the delivery system 10 is improved. On the other hand, in view of the fact that only a small portion of the valve 20 in the half-loaded state is compressed and located in the delivery chamber 111, and a large portion of the valve 20 is not compressed and located in the receiving chamber 4021, plastic deformation or damage of the valve 20 due to long-time compression can be effectively avoided, the service life of the valve 20 is prolonged, and normal use functions of the valve 20 implanted in the body can be guaranteed.

Third embodiment

Referring to fig. 32, the third embodiment provides a protection device 40b for protecting the delivery system 10 and the valve 20, which is suitable for use with a "wet-valve" valve 20, and which reduces the risk of damage to the delivery system 10 during loading of the valve 20 into the delivery system 10, and which also prevents contamination or damage to the valve 20 during shipping and storage. The third embodiment provides a protective device 40b comprising a sleeve assembly 401, a protective cover assembly 402 and an end cap 403, the sleeve assembly 401 comprising a body sleeve 500 and a connection sleeve 600; the boot assembly 402 includes a front boot 700 and a rear boot 800.

The cannula assembly 401 encloses a coaxially disposed large cylindrical lumen 4011, a small cylindrical lumen 4012, and a tapered lumen 4013. The large cylindrical cavity 4011, the small cylindrical cavity 4012 and the conical cavity 4013 are configured as a pipe cavity 4014 of the sleeve component 401, the small cylindrical cavity 4012 is communicated between the large cylindrical cavity 4011 and the conical cavity 4013, the diameters of the large cylindrical cavity 4011 and the small cylindrical cavity 4012 are uniformly arranged along the axial direction of the sleeve component 401, the diameters of the conical cavity 4013 are unevenly arranged, the diameter of the large cylindrical cavity 4011 is larger than the diameter of the small cylindrical cavity 4012, the diameter of the conical cavity 4013 is larger than or equal to the diameter of the small cylindrical cavity 4012, the diameter of the conical cavity 4013 is increased along the axial direction of the sleeve component 401 from the small cylindrical cavity 4012 to the conical cavity 4013.

In some examples, the body sleeve 500 may be a cylindrical tubular structure, the body sleeve 500 enclosing a first lumen 510 and a second lumen 520, the first lumen 510 configured as a large cylindrical lumen 4011, the bore of the first lumen 510 being greater than the bore of the second lumen 520, such that the body sleeve 500 has a stop surface 530 located between the first lumen 510 and the second lumen 520. For the delivery sheath 110 penetrating into the first cavity 510, when the end of the delivery sheath 110 abuts against the stop surface 530, the delivery sheath 110 will stop sliding close to the second cavity 520, so that the delivery sheath 110 cannot enter into the second cavity 520, and the stop surface 530 will limit the movement of the delivery sheath 110, so as to ensure that the delivery sheath 110 can only penetrate into the first cavity 510. When the end of the delivery sheath 110 abuts against the stop surface 530, the inner wall surfaces of the delivery lumen 111 and the second lumen 520 are substantially flush with each other, so that the valve 20 with the end connected to the retainer 122 is prevented from contacting the distal end surface and the outer wall of the delivery sheath 110 in the process of the sheath core 120 driving the retainer 122 to enter the delivery lumen 111, the valve 20 is prevented from generating resistance to the moving valve 20 by the distal end of the delivery sheath 110, and the valve 20 is prevented from hooking the distal end of the delivery sheath 110 to cause damage and sheath insertion failure of the delivery sheath 110, so that the valve 20 can be ensured to enter the delivery lumen 111 smoothly and completely without damage, and the damage probability of the delivery sheath 110 can be reduced. The section of the body sleeve 500 disposed adjacent to the second lumen 520 is provided with external threads for threaded connection with the connection sleeve 600.

An external thread for screw-coupling with the front protection cap 700 is provided on the outer circumferential surface of the coupling sleeve 600. The connection sleeve 600 encloses a third chamber 630, a fourth chamber 640 and a fifth chamber 650, the body sleeve 500 is inserted in the fifth chamber 650, an internal thread is provided on an inner wall surface of the fifth chamber 650, and the body sleeve 500 may be inserted in the fifth chamber 650 such that the internal thread and the external thread are engaged with each other, and thus the body sleeve 500 and the connection sleeve 600 are screw-coupled. A seal, such as a gasket (not shown), may also be provided in the fifth chamber 650, the gasket being pressed between the end of the body sleeve 500, which is the end of the body sleeve 500 inserted into the connection sleeve 600, and the connection sleeve 600, thereby sealing the gap between the body sleeve 500 and the connection sleeve 600. The third chamber 630 is connected between the fourth chamber 640 and the fifth chamber 650, the diameters of the second chamber 520 and the third chamber 630 are equal and are commonly configured as the small cylindrical chamber 4012, and the diameter of the fifth chamber 650 is larger than the diameter of the third chamber 630.

The fourth chamber 640 is configured as the tapered chamber 4013, and the caliber of the end of the fourth chamber 640 directly communicating with the third chamber 630 is equal to the caliber of the third chamber 630, and the caliber of the other part of the fourth chamber 640 is larger than the caliber of the third chamber 630. In the process that the sheath core 120 drives the valve 20 to slide so that the valve 20 enters the fourth cavity 640, the fourth cavity 640 can form a progressive compression effect on the valve 20, so that the friction resistance of the valve 20 entering the third cavity 630 is reasonably reduced, and the valve 20 is prevented from being damaged under the condition of overlarge friction resistance.

Referring to fig. 32, 33 and 34, in some examples, the front protection cover 700 includes a baffle 710 and a front cover 720, the front cover 720 is disposed around the baffle 710, a first front cavity 711 is formed on the baffle 710, the front cover 720 encloses a second front cavity 722, a third front cavity 723 and a fourth front cavity 724, and the first front cavity 711, the second front cavity 722, the third front cavity 723 and the fourth front cavity 724 are coaxially disposed and configured as a part of the accommodating cavity 4021. The first front cavity 711 and the fourth front cavity 724 are disposed near both ends of the entire front protection cover 700. The first front chamber 711, the second front chamber 722 and the fourth front chamber 724 are cylindrical chambers, and the diameters of the three chambers are all kept constant and uniformly arranged along the axial direction of the front protection cover 700. The third front chamber 723 is tapered such that the caliber of the third front chamber 723 is unevenly disposed in the axial direction of the front boot 700, pointing from the second front chamber 722 to the third front chamber 723 in the axial direction of the front boot 700, the caliber of the third front chamber 723 gradually increases such that the caliber of one end of the third front chamber 723 near the second front chamber 722 is approximately equal to the caliber of the second front chamber 722, and the calibers of the other parts of the third front chamber 723 are all larger than the caliber of the second front chamber 722. The caliber of one end of the third front cavity 723 near the fourth front cavity 724 is approximately equal to the caliber of the fourth front cavity 724, and the caliber of other parts of the third front cavity 723 is smaller than the caliber of the fourth front cavity 724. The caliber of each part of the second front cavity 722 is larger than that of the first front cavity 711, and the inner wall surface of the baffle 710 can be propped against the end part of the connecting sleeve 600, so that the front protective cover 700 is axially limited relative to the whole sleeve assembly 401.

The bore of the first front cavity 711 is substantially equal to the outer diameter of the body sleeve 500 such that the first front cavity 711 and the body sleeve 500 can form a sliding fit relationship. The bore of the second front lumen 722, the third front lumen 723 and the fourth front lumen 724 are larger than the outer diameter of the main body sleeve 500. The portion of the front housing 720 for enclosing the fourth front chamber 724 may be cylindrical, and an external thread is provided on the outer circumference of the portion, and the external thread is used for being screwed with the rear protection cover 800. The bore of the second front chamber 722 is substantially equal to the outer diameter of the coupling sleeve 600, and the inner wall surface of the second front chamber 722 is provided with an internal thread, so that when the internal thread is engaged with an external thread on the outer circumferential surface of the coupling sleeve 600, a screw-coupling relationship between the front boot 700 and the coupling sleeve 600 can be achieved. A sealing ring may also be disposed within the second front chamber 722 and may be pressed against between the baffle 710 and the end of the connection sleeve 600 to seal the gap between the connection sleeve 600 and the front boot 700.

Referring to fig. 32, 35 and 36, the rear cover 800 encloses a first rear chamber 810, a second rear chamber 820 and a third rear chamber 830, and the first rear chamber 810 and the second rear chamber 820 may be configured as a part of the accommodating chamber 4021 described above, so that the first front chamber 711, the second front chamber 722, the third front chamber 723, the fourth front chamber 724, the first rear chamber 810 and the second rear chamber 820 together form the accommodating chamber 4021. The first rear chamber 810 is further away from the front protection cover 700 than the second rear chamber 820, and the first rear chamber 810 and the third rear chamber 830 are each cylindrical, so that the calibers of the first rear chamber 810 and the third rear chamber 830 are maintained to be constantly and uniformly arranged along the axial direction of the rear protection cover 800. The second rear cavity 820 is tapered, so that the caliber of the second rear cavity 820 is unevenly arranged along the axial direction of the rear protection cover 800, the caliber of the second rear cavity 820 gradually increases along the axial direction of the rear protection cover 800 from the first rear cavity 810 to the second rear cavity 820, and the caliber of one end of the second rear cavity 820 close to the first rear cavity 810 is approximately equal to the caliber of the first rear cavity 810, and the calibers of other parts of the second rear cavity 820 are all larger than the caliber of the first rear cavity 810; the apertures of the third rear cavity 830 are all larger than the aperture of the second rear cavity 820; the cylindrical portion of the front cover 720 for enclosing the fourth front chamber 724 may be inserted into the cylindrical third rear chamber 830, and the inner wall surface of the third rear chamber 830 is provided with an internal thread engaged with an external thread on the cylindrical portion of the front cover 720 for enclosing the fourth front chamber 724, thereby achieving a threaded connection relationship between the front protection cover 700 and the rear protection cover 800. The portion of the rear protection cover 800 that encloses the third rear chamber 830 may also be cylindrical, and a gasket may also be placed in the third rear chamber 830, and the gasket abuts between the end of the front protection cover 700 and the bottom wall surface of the rear second rear chamber 820, so as to seal the gap between the front protection cover 700 and the rear protection cover 800. In other embodiments, the front protective cover 700 and the rear protective cover 800 may be cooperatively connected in other manners, for example, the front protective cover 700 may be sleeved outside the rear protective cover 800, external threads may be provided on the rear protective cover 800, and internal threads may be provided on the front protective cover 700, so as to realize threaded connection between the front protective cover 700 and the rear protective cover 800; for another example, the front protective cover 700 and the rear protective cover 800 may be detachably connected by a snap connection or the like.

An input port 811 is formed at an end of the first rear chamber 810 remote from the second rear chamber 820, and a sterilizing liquid can be introduced into the housing chamber 4021 through the input port 811, so that the valve 20 positioned in the housing chamber 4021 is sterilized and stored. The end cap 403 is detachably connected to the rear boot 800, for example, the end cap 403 is screwed to the rear boot 800. End cap 403 can seal the input port 811. A gasket is provided between the end cap 403 and the rear boot 800, which gasket will seal the gap between the end cap 403 and the rear boot 800.

Referring to fig. 43, the protector 40b further includes a pump assembly 900, the pump assembly 900 including a pump housing 910, a piston 920, and an infusion tube 930. Pump housing 910 encloses pump chamber 911, and pump housing 910 is last to be seted up first drain hole 912, and first drain hole 912 communicates pump chamber 911. The portion of rear boot 800 that is used to enclose first rear chamber 810 may be inserted into pump chamber 911 such that input port 811 is in communication with pump chamber 911. The outer circumferential surface of the portion of the rear protection cover 800 used to enclose the first rear chamber 810 may be provided with external threads, and the inner wall surface of the pump chamber 911 may be provided with internal threads, so that when the external threads are engaged with the internal threads, the screw connection relationship between the rear protection cover 800 and the pump housing 910 may be achieved. A gasket may be provided in the pump chamber 911, which abuts the end of the rear protection cover 800 and the pump case 910, thereby sealing a gap between the pump case 910 and the rear protection cover 800. The piston 920 is disposed through the pump chamber 911 such that the piston 920 is in sliding engagement with the pump chamber 911. The front cover 720 (refer to fig. 40) may be provided with a second liquid guiding hole 725, the second liquid guiding hole 725 may be communicated with the third front cavity 723 (refer to fig. 34), the infusion tube 930 is connected between the first liquid guiding hole 912 and the second liquid guiding hole 725, for example, two ends of the infusion tube 930 may be respectively screwed with the front protection cover 700 and the pump casing 910, so that liquid can flow between the first liquid guiding hole 912 and the second liquid guiding hole 725 through the infusion tube 930. The number of the first drain holes 912, the number of the second drain holes 725, and the number of the infusion tubes 930 are equal, for example, two may be used. When the piston 920 is pushed to reciprocate in the pump cavity 911, liquid enters the infusion tube 930 through the first liquid guide hole 912, and then enters the accommodating cavity 4021 from the infusion tube 930 through the second liquid guide hole 725; or enters the infusion tube 930 through the second liquid guide hole 725 and then enters the accommodating cavity 4021 from the infusion tube 930 through the first liquid guide hole 912, so that the liquid in the accommodating cavity 4021 is stirred.

Referring to fig. 41 and 42, the protective device 40b further includes a sealing cap 404, wherein the sealing cap 404 is removably coupled to the front protective cover 700, such as sealing the threaded connection with the front protective cover 700. The sealing cover 404 can seal the second pilot hole 725. A gasket is provided between the sealing cover 404 and the front protection cover 700, and seals a gap between the sealing cover 404 and the front protection cover 700. The second fluid delivery port 725 may be closed by a sealing cap 404 when the fluid delivery tube 930 is unloaded from the front cover 700.

In the use process of the protection device 40b provided in this second embodiment, the following steps mainly exist:

Referring to fig. 37, in a first step, the body sleeve 500 is inserted into the fifth chamber 650 such that the body sleeve 500 and the coupling sleeve 600 are threadedly coupled to form the sleeve assembly 401, and a sealing ring is disposed in the fifth chamber 650 of the coupling sleeve 600. The sleeve assembly 401 is then threaded into the front boot 700 such that the first front cavity 711 is a sliding fit with the body sleeve 500 and the second front cavity 722 of the front boot 700 is provided with a sealing ring. Finally, the delivery system 10 is threaded into the lumen 4014 of the cannula assembly 401 such that the end of the delivery sheath 110 abuts the stop surface 530 (see fig. 32) and the anchor 122 of the sheath core 120 is located outside the lumen 4014 and the end of the connection cannula 600 distal from the front boot 700 is located between the anchor 122 and the front boot 700. In addition, the sealing ring at the fifth chamber 650 also tightly encloses the sheath core 120 to achieve a seal between the third chamber 630 and the fifth chamber 650, preventing the sterilizing liquid in the eighth step from entering the delivery sheath 110.

Referring to fig. 38, in a second step, the loading device 30 (not shown, refer to fig. 26) is sleeved outside the valve 20, the end of the valve 20 to be compressed is close to the holder 122, the valve 20 is located in the accommodating cavity 220 and the isolation cavity 310 (refer to fig. 3-6), the sheath core 120 is simultaneously inserted into the isolation cavity 310 and the through hole 322, and the guide head 124 is inserted out of the through hole 322 and is located at the axial end of the through hole 322 far away from the holder 122; the loading device 30 is operated to compress the valve 20 at an end adjacent the holder 122, with the compressed end of the valve 20 extending from the opening of the loading assembly 200 at an end adjacent the holder 122, and when the valve 20 is compressed to a desired size at the end, the compressed end of the valve 20 is connected to the holder 122.

Third, the delivery system 10 is driven such that the delivery sheath 110 and the entire cannula assembly 401 are moved toward the loading device 30, and the holder 122 is just proximal to the end of the fourth lumen 640 when the loading device 30 abuts the end of the cannula assembly 401. In other embodiments, the delivery sheath 110 and cannula assembly 401 may also be held stationary, but rather the sheath core 120 is pulled proximally relative to the cannula assembly 401.

Referring to fig. 39, in a fourth step, the loading device 30 is unloaded from the sheath core 120, and the handling section 121 of the sheath core 120 is pulled, such that the holder 122 passes through the fourth lumen 640 into the third lumen 630, which in turn causes a portion of the valve 20 to be received in both the third lumen 630 and the fourth lumen 640.

In view of the tapered shape of the fourth chamber 640, the inner wall surface of the fourth chamber 640 may provide good guiding and pre-compression of the retainer 122 and the valve 20 during the entry of the retainer 122 into the fourth chamber 640 and the third chamber 630, reducing friction and collision resistance of the valve 20 and the retainer 122 into the third chamber 630 and the fourth chamber 640, and allowing the retainer 122 and the valve 20 to smoothly enter the third chamber 630 and the fourth chamber 640.

Referring to fig. 40, in a fifth step, the front protection cover 700 is moved close to the connection sleeve 600, at this time, the main body sleeve 500 slides with respect to the first front cavity 711 of the front protection cover 700, and when the front protection cover 700 contacts with the connection sleeve 600, the front protection cover 700 is rotated, so that the internal thread in the front protection cover 700 is engaged with the external thread of the connection sleeve 600, thereby realizing the threaded connection relationship between the front protection cover 700 and the connection sleeve 600, so that the front protection cover 700 is fixedly arranged on the sleeve assembly 401, and of course, the sealing ring placed in the second front cavity 722 of the front protection cover 700 is abutted with the connection sleeve 600.

Referring to fig. 41, in a sixth step, the rear protection cover 800 is rotated, so that a portion of the front protection cover 700 surrounding the fourth front cavity 724 is inserted into the third rear cavity 830 of the rear protection cover 800, a sealing ring is disposed in the third rear cavity 830, and external threads on the front protection cover 700 are engaged with internal threads in the third cavity 630 of the rear protection cover 800, thereby realizing a threaded connection relationship between the rear protection cover 800 and the front protection cover 700, and also enabling the sealing ring to be pressed between the end of the front protection cover 700 and the rear protection cover 800. Such that a portion of valve 20 is received in lumen 4014 and another portion of valve 20 is received in receiving lumen 4021 (see fig. 32), sleeve assembly 401 and protective cap assembly 402 cooperate to provide protection to valve 20, i.e., delivery system 10 pre-loads or semi-loads valve 20, while valve 20 is in a pre-loaded or semi-loaded state relative to delivery system 10. Moreover, the entire delivery system 10 is threaded into the cannula assembly 401 and the boot assembly 402 such that the cannula assembly 401 and the boot assembly 402 also cooperate to provide protection to the delivery system 10.

Referring to fig. 41, in a seventh step, the sealing cover 404 is fixed on the front protection cover 700, and a sealing ring is arranged between the sealing cover 404 and the front protection cover 700, and the sealing ring is pressed between the sealing cover 404 and the front protection cover 700, so as to seal the second liquid guide hole 725 by the sealing cover 404.

Referring to fig. 42, in an eighth step, a sterilizing liquid is injected into the accommodating chamber 4021 through the input port 811, so that the sterilizing liquid sterilizes and disinfects the valve 20 located in the accommodating chamber 4021, then, the end cover 403 is fixed on the rear protection cover 800, a sealing ring is arranged between the end cover 403 and the rear protection cover 800, and the sealing ring is pressed between the end cover 403 and the rear protection cover 800, so that the end cover 403 seals the input port 811. At this point, the entire protector 40b, delivery system 10 and valve 20 may be packaged as a unitary packaged instrument for shipping and storage, and protector 40b will always provide protection to delivery system 10 and valve 20 during shipping and storage, preventing damage to or contamination by viruses from delivery system 10 and valve 20.

Referring to fig. 43, prior to performing the procedure, protective device 40b, delivery system 10, and valve 20, which are a packaged device, may be removed, and end cap 403 removed to open input port 811, such that the sterilizing fluid in housing lumen 4021 is exhausted from input port 811. When cleaning of the cleaning liquid remaining on the valve 20 is required, physiological saline may be injected into the receiving chamber 4021 from the input port 811, and then the sealing cover 404 is unloaded from the front protective cover 700 to open the second fluid guide 725. A sealing ring is then placed in the pump chamber 911 of the pump housing 910, and the pump housing 910 is screwed with the rear protection cover 800, so that the rear protection cover 800 is inserted into the pump chamber 911. The two ends of the infusion tube 930 are then screwed together with the front boot 700 and the pump housing 910, so that the infusion tube 930 is connected between the first and second fluid guide holes 912 and 725. The piston 920 is pushed to slide back and forth in the pump cavity 911, so that the physiological saline in the accommodating cavity 4021 flows back and forth through the first liquid guide hole 912, the second liquid guide hole 725 and the infusion tube 930, thereby stirring the physiological saline in the accommodating cavity 4021, and finally cleaning the sterilizing liquid remained on the valve 20 by the physiological saline. When the sterilizing liquid remaining on the valve 20 is not required to be washed, the step of injecting the physiological saline into the receiving chamber 4021 can be omitted, and obviously, the step of stirring the physiological saline by the pump assembly 900 can be omitted.

After the valve 20 is washed by physiological saline; the entire pump assembly 900 may be unloaded from the boot assembly 402, followed by rotation of the front boot 700; alternatively, the front protector 700 may be rotated directly after the sterilizing fluid is exhausted from the valve 20 without washing with physiological saline. By rotating the front boot 700 to release the threaded connection between the front boot 700 and the connection sleeve such that the stop 710 of the front boot 700 moves away from the connection sleeve, the body sleeve 500 will slide relative to the first front cavity 711 and the rear boot 800 will follow the synchronous movement of the front boot 700. During movement of the baffle 710 of the front boot 700 away from the connecting sleeve (movement of the front boot 700 may refer to fig. 31), the sheath core 120 will gradually penetrate into the first rear chamber 810, whereas the second rear chamber 820 is tapered, the second rear chamber 820 will compress and guide the valve 20 such that the compressed valve 20 smoothly enters the first rear chamber 810. Finally, the manipulation section 121 is pulled at a reasonable rate so that the valve 20 compressed in the first rear lumen 810 smoothly enters the delivery lumen 111 of the delivery sheath 110 so that the entire valve 20 will be fully compressed and housed in the delivery lumen 111, at which point the valve 20 is in a fully loaded state relative to the delivery system 10. In general, the delivery system 10 may be configured to implant the valve 20 in a fully loaded state into the body during surgery.

The protection device 40b can make the valve 20 in a half-loading state, and before performing an operation, the valve 20 in the half-loading state is converted into a full-loading state, so that on one hand, the loading time of the valve 20 can be greatly reduced, and the operation can be performed in a time point so as to rapidly rescue a patient. On the other hand, the protection device 40b protects the valve 20 which has been subjected to the sterilization and cleaning process, and the protection device 40b can convert the valve 20 into a fully loaded state, so that bacterial and viral infections of the valve 20 and the delivery system 10 caused by other auxiliary devices used in the loading process are avoided, and the safety of the valve 20 and the delivery system 10 is improved. On the other hand, in view of the fact that only a small portion of the valve 20 in the half-loaded state is compressed and located in the delivery chamber 111, and a large portion of the valve 20 is not compressed and located in the receiving chamber 4021, plastic deformation or damage of the valve 20 due to long-time compression can be effectively avoided, the service life of the valve 20 is prolonged, and normal use functions of the valve 20 implanted in the body can be guaranteed.

The protection device 40b provided in this second embodiment may also be used to protect the valve 20 that has been treated with sterilizing gas during actual use, so that the protection device 40b provided in this second embodiment may be applicable not only to "wet lobes" but also to "dry lobes".

Third embodiment

The present embodiment provides a loading device 30a for compressing the valve 20 to receive the valve 20 into the delivery system 10. The specific structure of the conveying system 10 may refer to the description of the first embodiment, and this embodiment will not be repeated.

Referring to fig. 44, the loading device 30a includes a loading assembly 200, an isolation assembly 300, and a pressing member 400. The loading assembly 200 includes a receiving structure including a receiving cavity 220 and a compression port in communication with the receiving cavity 220. The housing structure further includes a loading portion 210, and the number of loading portions 210 may be one, and in other embodiments, the number of loading portions 210 may be plural. The loading part 210 includes a loading unit 211 and a boss 212, the loading unit 211 encloses a receiving cavity 220, the receiving cavity 220 may be tapered, and the diameter of the receiving cavity 220 may be gradually reduced to communicate with the compression port from the compressing member 400 toward the compression port in the axial direction of the loading device 30. The protrusion 212 is convexly provided on the outer side surface of the loading unit 211 such that the protrusion 212 protrudes a certain length in the radial direction of the loading unit 211 with respect to the loading unit 211 and is located outside the receiving chamber 220. The boss 212 defines a receptacle 2121 into which the isolation assembly 300 can be inserted to mate with the receptacle 2121. The protruding portion 212 is further provided with a first thread, and the pressing member 400 is provided with a second thread, so that the protruding portion 212 and the pressing member 400 can be connected through the first thread and the second thread. In the present embodiment, two protrusions 212 are provided on the loading unit 211 at intervals, and the two protrusions 212 are symmetrically provided in the radial direction. In other embodiments, the number of protrusions 212 may be one or more than two, and may also be used to interact with the spacer assembly 300 and the compression member 400.

The loading unit 211 includes a tip section 2113 and a connecting section 2114, the connecting section 2114 being disposed circumferentially outside the tip section 2113 and connected to the tip section 2113, for example, the tip section 2113 and the connecting section 2114 being fixedly connected to each other at an axial end thereof remote from the compression port. Both the tip section 2113 and the connecting section 2114 may be coaxially disposed or may be non-coaxially disposed. The boss 212 is disposed on the connection segment 2114. The connection section 2114 is cylindrical, the tip section 2113 is similarly tapered, and the outer diameter of the connection section 2114 is kept constant from the connection section 2114 toward the tip section 2113 in the axial direction of the loading unit 211, and the outer diameter of the tip section 2113 gradually decreases. In other embodiments, the connecting segment 2114 and the tip segment 2113 may be other shapes, for example, the connecting segment 2114 may be tapered, the tip segment 2113 may be cylindrical, or both the connecting segment 2114 and the tip segment 2113 may be cylindrical, regardless of the shape, as long as the caliber of the receiving chamber 220 may gradually decrease from the compression member 400 toward the compression port in the axial direction of the loading device 30.

In this embodiment, the outer surface of the tip section 2113 may be further provided with an anti-slip unit 2115, and the anti-slip unit 2115 includes an anti-slip groove 2116 extending along the length direction of the tip section 2113, and the anti-slip groove 2116 is recessed from the outer surface of the tip section 2113 toward the direction approaching the receiving cavity 220. The number of the anti-slip grooves 2116 may be one or more, for example, the number of the anti-slip grooves 2116 may be six. When the plurality of anti-slip grooves 2116 are provided, the plurality of anti-slip grooves 2116 may be circumferentially spaced along the tip section 2113, for example, equally spaced or non-equally spaced. The anti-slip unit 2115 may act as an anti-slip when the operator holds the tip section 2113. In other embodiments, the anti-slip grooves 2116 may be replaced with anti-slip ribs, or the anti-slip unit 2115 includes both anti-slip grooves 2116 and anti-slip ribs. In other embodiments, the anti-slip unit 2115 may be omitted.

A gap is formed between the outer surface of the tip section 2113 and the inner surface of the connecting section 2114, in which gap the reinforcing ribs 2117 may be provided, and the number of the reinforcing ribs 2117 may be one or more, for example, six reinforcing ribs 2117 may be provided at intervals. The rib 2117 has a sheet shape, and one end is connected to the outer surface of the tip portion 2113 and the other end is connected to the inner surface of the connecting portion 2114. It will be appreciated that the stiffener 2117 described above may be omitted.

The shape and structure of the isolation assembly 300 and the pressing member 400 are substantially the same as those of the first embodiment, and the description of the first embodiment will be omitted herein, wherein the isolation assembly 300 of the present embodiment further includes a limiting unit 331, and the limiting unit 331 is used for limiting the valve 20 located in the isolation chamber 310 from moving relative to the isolation assembly 300 in the axial direction, so as to prevent a part of the valve 20 having an outer diameter larger than the inner diameter of the isolation chamber 310 from being ejected from the isolation chamber 310 when the valve 20 is placed in the isolation chamber 310. The limiting unit 331 is connected to the surrounding tube 330, and protrudes from the surrounding tube 330 into the isolation cavity 310, and a space exists between the limiting unit 331 and the isolation plate 320. The whole limit unit 331 may extend along the circumferential direction of the surrounding tube 330, and the number of the limit units 331 may be one or more, for example, when the limit unit 331 is one, the limit unit 331 may surround the inner wall of the surrounding tube 330 for better limit effect, and when the limit unit 331 is two or more than two, the limit units 331 are approximately curved and are arranged at intervals. It is understood that the above-described limiting unit 331 may be omitted.

Referring to fig. 45-48, the present embodiment also provides a sleeve assembly 401a, the sleeve assembly 401a including a main body sleeve 500, a connection sleeve 600, and a fixing tube 501. In some examples, the body sleeve 500 includes two tabs 520, one end of each of the two tabs 520 being connected to the fixed tube 501, e.g., the fixed tube 501 is sleeved outside one end of the two tabs 520 and threadably connected to the two tabs 520, and the other ends of the two tabs 520 being capable of opening and closing with respect to each other. The fixing tube 501 may have a cylindrical tubular structure, and the fixing tube 501 may have a circumferential closed structure or a circumferential non-closed structure, so long as it can serve to connect one ends of the two opening and closing pieces 520. When the two folding pieces 520 are folded, the two folding pieces 520 that are folded with each other may be spliced to form a tubular structure, and a main body portion of the tubular structure may be cylindrical or any other suitable shape. In a natural state in which the main body sleeve 500 does not cooperate with the coupling sleeve 600 and the fixing tube 501, the entirety of the opening and closing piece 520 is curved, that is, the opening and closing piece 520 is not linear. When the body sleeve 500 is fitted with the fixing tube 501 but not with the coupling sleeve 600, one ends of the two opening and closing pieces 520 are connected with the fixing tube 501, and the other ends of the two opening and closing pieces 520 are spaced apart from each other to be opened. The stent-graft 520 itself has a certain deformability, and when a pressing force is applied to the stent-graft 520 in the radial direction of the main body sheath 500, the stent-graft 520 is closed to be in a closed state, and when the pressing force is gradually reduced until the stent-graft is completely withdrawn, the distance between the ends of the stent-graft 520 distant from the fixed tube 501 is gradually increased until the stent-graft is restored to the fully opened state. In other examples, two of the tabs 520 may be interconnected to form a tubular structure without having a changing relationship between open and closed states.

The cannula assembly 401 includes a coaxially disposed large cylindrical lumen 4011, a small cylindrical lumen 4012, and a tapered lumen 4013. The large cylindrical cavity 4011, the small cylindrical cavity 4012 and the conical cavity 4013 are configured as a lumen 4014 of the casing assembly 401, the small cylindrical cavity 4012 is communicated between the large cylindrical cavity 4011 and the conical cavity 4013, the caliber of the conical cavity 4013 is unevenly arranged along the axial direction of the casing assembly 401, the caliber of the large cylindrical cavity 4011 is larger than the caliber of the small cylindrical cavity 4012, the caliber of the conical cavity 4013 is larger than or equal to the caliber of the small cylindrical cavity 4012, the conical cavity 4013 is pointed from the small cylindrical cavity 4012 to the conical cavity 4013 along the axial direction of the casing assembly 401, and the caliber of the conical cavity 4013 is increased.

The fixing tube 501 comprises a first cavity 511, and when in a closed state, the two opening and closing sheets 520 comprise a second cavity 522, a third cavity 523 and a fourth cavity 524, the second cavity 522, the third cavity 523 and the fourth cavity 524 are sequentially arranged along the axial direction of the main body sleeve 500, and two ends of the tube cavity 4014 are respectively positioned on the first cavity 511 and the fourth cavity 524. The caliber of the first chamber 511 is larger than the caliber of the second chamber 522, both the first chamber 511 and the second chamber 522 are configured as the above-described large cylindrical chamber 4011, or the second chamber 522 is configured as the above-described large cylindrical chamber 4011, the third chamber 523 is smaller than the caliber of the second chamber 522 and configured as the above-described small cylindrical chamber 4012, and the fourth chamber 524 is configured as the above-described tapered chamber 4013.

In view of the fact that the caliber of the third cavity 523 is smaller than that of the second cavity 522, the inner wall surfaces of the third cavity 523 and the second cavity 522 are not flush, and then the opening and closing piece 520 is provided with a first stop surface 525 located between the second cavity 522 and the third cavity 523, for the delivery sheath 110 penetrating into the first cavity 511 and the second cavity 522, when the end of the delivery sheath 110 abuts against the first stop surface 525, the delivery sheath 110 stops sliding close to the third cavity 523, so that the delivery sheath 110 cannot enter into the third cavity 523, and the first stop surface 525 plays a limiting role on the movement of the delivery sheath 110, so that the delivery sheath 110 can only penetrate into the first cavity 511 and the second cavity 522. Of course, for the sheath core 120 to be threaded in the delivery lumen 111 of the delivery sheath 110, the sheath core 120 may be threaded in the first lumen 511, the second lumen 522, the third lumen 523, and the fourth lumen 524 simultaneously. The caliber of the delivery lumen 111 of the delivery sheath 110 may be equal to the caliber of the third lumen 523, when the end of the delivery sheath 110 abuts against the first stop surface 525, the inner wall surfaces of the delivery lumen 111 and the third lumen 523 are substantially flush, and in the process that the sheath core 120 drives the holder 122 to enter the delivery lumen 111, the valve 20 with the end connected with the holder 122 is prevented from contacting with the distal end surface and the outer wall of the delivery sheath 110, so as to avoid the resistance of the distal end of the delivery sheath 110 to the valve 20 in motion, and the valve 20 end hooks the distal end of the delivery sheath 110 to cause damage and sheath insertion failure of the delivery sheath 110, so that the valve 20 can be ensured to enter the delivery lumen 111 smoothly, and the damage probability of the delivery sheath 110 can be reduced.

The main body sleeve 500 sequentially includes a first segment 520a, a second segment 520b, and a third segment 520c in an axial direction, wherein the first segment 520a is used for being connected with the fixing tube 501, the fixing tube 501 can be sleeved outside the first segment 520a, the third segment 520c is used for being connected with the connection sleeve 600, and the connection sleeve 600 is detachably sleeved outside the third segment 520 c. When the two opening and closing pieces 520 are folded, a second stop surface is formed between the outer walls of the second section 520b and the third section 520c of the main body sleeve 500, for example, the outer diameter of the third section 520c is smaller than that of the second section 520b, so that the end, close to the third section 520c, of the second section 520b forms a second stop surface, and when the connecting sleeve 600 is sleeved on the third section 520c, the second stop surface can play a limiting role, so that the end, far away from the fixed pipe 501, of the two opening and closing pieces 520 is located in the connecting sleeve 600, and the problem that the folding form of the two opening and closing pieces 520 is poor due to the fact that the opening and closing pieces 520 extend out from the end, far away from the fixed pipe 501, of the connecting sleeve 600 is avoided, and the conveying system 10 cannot be well protected is solved. Further, in order to better fasten the two opening and closing pieces 520 and better protect the delivery system 10 by the connection sleeve 600, the strength of the connection sleeve 600 is greater than that of the opening and closing pieces 520 (the strength may be tensile strength), for example, the connection sleeve 600 is made of a metal material such as stainless steel or nitinol, and the Zhang Gepian is made of a polymer material such as polycarbonate. In other embodiments, the connection sleeve 600 and the stent 520 may be made of a metal material with higher hardness, or made of a polymer material.

In this embodiment, the first section 520a and the fixing tube 501 are detachably connected, for example, by a threaded connection manner, the outer wall of the first section 520a is provided with an external thread, the inner wall of the fixing tube 501 is provided with an internal thread matching with the external thread of the first section 520a, or the outer wall of the first section 520a is provided with an internal thread, and the inner wall of the fixing tube 501 is provided with an external thread matching with the internal thread of the first section 520 a. In other embodiments, the first segment 520a and the fixed pipe 501 may be detachably connected by a snap fit, etc., and in other embodiments, the first segment 520a and the fixed pipe 501 may be non-detachably connected by adhesion, welding, hot melt connection, etc. Compared with the scheme that one ends of the two folding pieces 520 are connected with the fixing section 510 in the first embodiment, in this embodiment, the first section 520a and the fixing tube 501 are detachably connected, and the fixing tube 501 is sleeved outside the first section 520a, so that the problem that the two folding pieces 520 far away from one end of the connecting sleeve 600 in the first embodiment are prone to stress concentration and possibly damaged in the production and use processes is well solved. Further, the outer surface of the fixing tube 501 is provided with one or more anti-slip ribs 501a, which play a role in preventing slipping. In other embodiments, non-slip ridge 501a may be omitted.

The main body sleeve 500 further comprises a limiting portion 502, the limiting portion 502 comprises a limiting projection 5021 and a limiting groove, the limiting projection 5021 is arranged on the circumferential side wall of one opening and closing piece 520, and the limiting groove is correspondingly arranged on the circumferential side wall of the other opening and closing piece 520. When the two folding pieces 520 are folded, the limit protrusion 5021 of one folding piece 520 is embedded into the limit groove 5022 of the other folding piece 520, so that the two folding pieces 520 can be prevented from moving mutually in the axial direction. In this embodiment, the main body sleeve 500 includes two limiting portions 502, the two limiting portions 502 are disposed at intervals in the circumferential direction, and the two circumferential sides of each opening and closing sheet 520 are respectively provided with a limiting bump 5021 and a limiting groove 5022, wherein the limiting bump 5021 of one opening and closing sheet 520 and the limiting groove 5022 of the other opening and closing sheet 520 cooperate with each other to realize axial limiting. In other embodiments, one of the opening and closing sheets 520 is provided with a limiting protrusion 5021 on each of two circumferential sides, and the other opening and closing sheet 520 is provided with a limiting groove 5022 on each of two circumferential sides. In other embodiments, the body sleeve 500 may also be provided with one or more stops 502.

For convenience of description, the loading device 30a will be described by taking the example that the loading device 30a includes the isolation assembly 300 configured to form the isolation chamber 310 through only the first limiting chamber 361, i.e., the loading device 30a employs the isolation assembly 300 shown in fig. 6. When it is desired to compress the valve 20 by means of the loading device 30, the following operative steps may be present:

In a first step, the delivery sheath 110 is threaded into the lumen 4014 of the body sleeve 500 such that the distal end of the delivery sheath 110 abuts the first stop surface 525 of the body sleeve 500, thereby axially positioning the delivery sheath 110 such that the delivery sheath 110 is threaded into the first and second lumens 511, 522, while the sheath core 120 is threaded into the delivery lumen 111 of the delivery sheath 110 such that the manipulation section 121 and the delivery lumen 111 are mated, and the sheath core 120 is also threaded into the third and fourth lumens 523, 524 of the body sleeve 500, and exposing the retainer 122 out of the lumen 4014 of the body sleeve 500. Then, the connecting sleeve 600 is inserted through the opening and closing piece 520, and the connecting sleeve 600 is matched with the third section 520c, so that the two opening and closing pieces 520 are completely closed.

In the second step, the loading assembly 200 of the loading device 30a is sleeved outside the sheath core 120, so that the compression port of the loading assembly 200 faces the direction of the fixing tube 501, and then the valve 20 is sleeved outside the sheath core 120, a part of the valve 20 is located in the accommodating cavity 220, and the fixer 122 on the sheath core 120 is located near the end with smaller caliber of the accommodating cavity 220.

Third, the stopper 215 of the isolation assembly 300 is inserted into the insertion hole 2121 of the boss 212 so that the valve 20 is received in the receiving chamber 220 and the isolation chamber 310.

Fourth, the side cylinder 420 of the pressing member 400 is sleeved on the surrounding cylinder 330 of the isolation assembly 300, and the side cylinder 420 is rotated so that the side cylinder 420 is screwed with the boss 212. During rotation, the gland 410 will push the spacer 320 progressively closer to the loading portion 210, such that the spacer 320 progressively pushes the valve 20 away from the end of the holder 122 progressively closer to the smaller bore end of the receiving chamber 220. In view of the conical shape of the receiving chamber 220, the loading portion 210 will radially compress the valve 20 during movement of the valve 20 relative to the receiving chamber 220, thereby reducing the outer diameter of the valve 20. In fact, the loading portion 210 mainly compresses the end of the valve 20 close to the holder 122 to interconnect the end of the valve 20 with the holder 122.

Fifth, the delivery system 10 is actuated such that the delivery sheath 110 and the entire sleeve assembly 401 are moved toward the loading device 30 to load the valve 20 into the delivery sheath 110. In other embodiments, the delivery sheath 110 and the sleeve assembly 401 may also be held stationary, but rather the sheath core 120 is pulled to move proximally relative to the sleeve assembly 401 to load the valve 20 into the delivery sheath 110. After the valve 20 is loaded, the loading device 30a and the sleeve assembly 401 are removed.

The outer diameter of the end of the loading device 30a adapter sleeve 600 distal from the stationary tube 501 is smaller than the inner diameter of the compression port of the loading device 30a such that the adapter sleeve 600 can be threaded into the loading device 30a from the compression port of the device 30a and the loading device 30a can be slid a distance over the adapter sleeve 600. During the fifth step, the loading device 30a may be sleeved onto the connection sleeve 600 to facilitate the operator's view of the loading of the valve 20.

The loading device 30a in the above embodiment makes the valve 20 located in the accommodating cavity 220 and the isolation cavity 310 unable to contact with the pressing member 400 through the isolation action of the isolation assembly 300, so that friction between the pressing cover 410 and the valve 20 can be effectively avoided, on one hand, abrasion of the valve 20 can be avoided, and on the other hand, generation of debris material can be effectively prevented. In fact, during the movement of the valve 20 in the housing cavity 220 pushed by the pressing member 400 through the isolation assembly 300, the isolation assembly 300 always moves synchronously with the valve 20, i.e. the isolation assembly 300 and the valve 20 do not move relatively, so that the abrasion between the isolation assembly 300 and the valve 20 due to friction is eliminated. Meanwhile, although the valve 20 rubs against the inner wall surface of the receiving chamber 220, the pressure between the loading part 210 and the valve 20 is small, and the friction between the valve 20 and the loading part 210 will not be enough to damage the valve 20.

Fourth embodiment

Referring to fig. 49-51, the loading device 30b provided in this embodiment is used to compress the valve 20 to accommodate the valve 20 within the delivery system 10. The specific structure of the conveying system 10 may refer to the description of the first embodiment, and this embodiment will not be repeated.

The loading device 30b of the present embodiment is substantially the same as the third embodiment, and the differences are that the structure and the position of the anti-slip unit 2115 of the loading device 30b of the present embodiment and the connection manner of the isolation plate 320 and the surrounding tube 330 in the isolation assembly 300 are not repeated.

In this embodiment, the anti-slip unit 2115 is coupled to a coupling segment 2114 of the loading assembly 200. The anti-slip unit 2115 includes a grip 2118 and an anti-slip groove 2116 provided on an outer surface of the grip 2118. The grip 2118 may be in the form of a sheet or any other suitable shape, with the grip 2118 being connected to the connecting section 2114 and extending in a direction toward the compression port. The number of gripping members 2118 may be two (in other embodiments, the number of gripping members 2118 may be one or more than two), and two gripping members 2118 are disposed opposite each other on opposite sides of the tip section 2113 for convenient gripping by an operator. The grip 2118 is circumferentially spaced from the boss 212 of the loader assembly 200, and a finger placed on the grip 2118 by an operator interferes with the positioning block 340 inserted in the boss 212. The number of anti-slip grooves 2116 on the grip 2118 may be one or more, for example, the number of anti-slip grooves 2116 may be five. When the plurality of anti-slip grooves 2116 are provided, the plurality of anti-slip grooves 2116 may be spaced apart, for example, at equidistant intervals, or at non-equidistant intervals. The anti-slip unit 2115 may function as an anti-slip when the operator holds the grip 2118. In other embodiments, the anti-slip grooves 2116 may be replaced with anti-slip ribs, or the anti-slip unit 2115 includes both anti-slip grooves 2116 and anti-slip ribs. In other embodiments, the anti-slip unit 2115 may be omitted.

Further, the anti-slip unit 2115 may further include a support 2119, the support 2119 being provided between the grip 2118 and the tip section 2113, and connecting the grip 2118 and the tip section 2113, respectively. The support members 2119 provide radial support to the grip member 2118, which is advantageous for improving the mechanical strength of the grip member 2118 and avoiding damage to the grip member 2118 due to radial forces during operation. In other embodiments, the support 2119 may connect only one of the grip 2118 and the tip section 2113, and not necessarily connect both the grip 2118 and the tip section 2113 at the same time, so long as the support 2119 can abut between both the grip 2118 and the tip section 2113 when the grip 2118 is radially compressed and limit continued radial deformation of the grip 2118. It will be appreciated that in other embodiments, the support 2119 may be omitted.

In this embodiment, the spacer 320 of the spacer assembly 300 is detachably connected to the surrounding cylinder 330. For example, an engaging unit 370 is disposed between the isolation board 320 and the surrounding tube 330, where the engaging unit 370 includes a first engaging member 371 and a second engaging member 372 that can be mutually engaged and fixed and detachable, and the first engaging member 371 is disposed on the isolation board 320, for example, the first engaging member 371 is a hook with a certain elasticity, and is fixedly connected to an outer peripheral edge of the isolation board 320 and extends toward the surrounding tube 330. The second engaging member 372 is disposed on the surrounding cylinder 330, for example, the second engaging member 372 is an engaging groove formed on an outer peripheral edge of the surrounding cylinder 330, and can be engaged and fixed when the hook is engaged with the engaging groove, and released and separated when the hook is disengaged from the engaging groove. In other embodiments, the first engaging member 371 may be an engaging groove, and the second engaging member 372 may be a hook. The number of the engaging units 370 may be one or more, for example, four, and when a plurality of engaging units 370 are provided, the plurality of engaging units 370 may be disposed at intervals in the circumferential direction of the isolation assembly 300, for example, may be disposed at equidistant intervals, or may be disposed at non-equidistant intervals, and when disposed at equidistant intervals, the isolation plate 320 and the surrounding cylinder 330 may be more firmly connected to each other. In other embodiments, the spacer 320 and the surrounding canister 330 may be removably coupled by a threaded connection or the like. The isolation plate 320 and the surrounding cylinder 330 in this embodiment are detachably connected, so that on one hand, the processing is convenient, and on the other hand, the replacement of the isolation plate 320 can be realized, so that the valve 20 with various specifications can be suitable.

It will be appreciated that the loading device, sleeve assembly and protection device of the present invention may also be adapted for use with other implantation devices than valves, such as interventional medical devices like vascular stents, provided that the implantation device has a compressed state loaded in the delivery system and a deployed state released from the delivery system.

The present invention provides a medical instrument system comprising any of the loading devices described above and/or any of the protection devices described above. Wherein the implantation instrument comprises a valve, a stent, etc.

The invention provides a medical instrument system, which comprises an implantation instrument, a conveying system, any loading device and/or any protecting device. Wherein the implantation instrument comprises a valve, a stent, etc.

The present invention provides a medical instrument system comprising any of the loading devices described above and/or any of the cannula assemblies described above.

The invention provides a medical instrument system, which comprises an implantation instrument and a conveying system, and further comprises any loading device and/or any sleeve assembly. Wherein the implantation instrument comprises a valve, a stent, etc.

The technical features of the above-described embodiments may be arbitrarily combined, and all possible combinations of the technical features in the above-described embodiments are not described for brevity of description, however, as long as there is no contradiction between the combinations of the technical features, they should be considered as the scope of the description.

The above examples illustrate only a few embodiments of the invention, which are described in detail and are not to be construed as limiting the scope of the invention. It should be noted that it will be apparent to those skilled in the art that several variations and modifications can be made without departing from the spirit of the invention, which are all within the scope of the invention. Accordingly, the scope of protection of the present invention is to be determined by the appended claims.

Claims

1. A protective device adapted to protect an implantation instrument and a delivery system, the protective device comprising:

2. The protective device according to claim 1, wherein the sleeve assembly comprises a main sleeve and a connecting sleeve, the main sleeve comprises a fixed section and two opening and closing pieces, the two Zhang Gepian are connected with the fixed section and can be arranged at intervals to open and close each other, and when the connecting sleeve is sleeved on one end of the Zhang Gepian far away from the fixed section, the two opening and closing pieces are closed and form a first sliding groove which is in sliding fit with the protective cover assembly.

3. The protective device of claim 1, wherein the sleeve assembly comprises two open-close pieces, the two Zhang Gepian being capable of opening and closing with each other, the lumen comprising a large cylindrical cavity and a small cylindrical cavity in communication with the large cylindrical cavity when the two open-close pieces are closed, the large cylindrical cavity having a larger caliber than the small cylindrical cavity.

4. A protective device according to claim 3, wherein when the two opening and closing sheets are closed, the lumen further includes a tapered cavity, the small cylindrical cavity is communicated between the large cylindrical cavity and the tapered cavity, the caliber of the tapered cavity is equal to or larger than that of the small cylindrical cavity, and the caliber of the tapered cavity increases in a direction from the small cylindrical cavity toward the tapered cavity.

5. The protective device according to claim 2, wherein the fixed section is provided with a second chute extending to two ends of the fixed section, and the second chute is communicated with the first chute and is in sliding fit with the protective cover assembly.

6. The protective device according to claim 2, wherein grooves are concavely formed on the outer peripheral surfaces of the two opening and closing pieces, the two grooves extend along the circumferential direction and are communicated with each other, and the protective cover assembly comprises a buckle matched with the grooves.

7. The protection device according to claim 2, wherein a clearance hole is concavely formed on the outer peripheral surfaces of the two opening and closing pieces, and the clearance hole is communicated with the lumen and the first chute.

8. The protective device of claim 7, wherein a sidewall surface of the clearance hole is directly connected to a sidewall surface of the first chute to form an obtuse angle.

9. The protection device according to claim 2, wherein the main body sleeve further comprises a boss, the boss is arranged on the outer peripheral surface of the opening and closing piece in a protruding mode, a first clamping groove and a second clamping groove which are communicated with each other are formed in the connecting sleeve, the first clamping groove extends along the axial direction, the second clamping groove extends along the circumferential direction, and the boss can be matched with the second clamping groove through the first clamping groove.

10. The protective device according to claim 2, wherein a third chute slidingly engaged with the protective cover assembly is formed in the connecting sleeve, and the third chute communicates with the first chute and maintains a set distance from an end of the connecting sleeve remote from the fixed section.

11. The protective device according to claim 2, wherein the connecting sleeve comprises a tightening segment and a convex ring, the tightening segment is sleeved on the opening and closing piece, the convex ring is arranged around and protrudes from one end of the tightening segment away from the fixing segment, and the convex ring can be abutted with the protective cover assembly along the axial direction.

12. The protector according to claim 11 wherein the tightening segment defines a tapered bore, the opening and closing piece including a tapered portion, the tapered bore having a gradually increasing diameter and the tapered portion having a gradually decreasing outer diameter in a direction from the fixed segment toward the opening and closing piece when the connecting sleeve is sleeved on an end of the Zhang Gepian remote from the fixed segment; when the connecting sleeve is folded, the connecting sleeve and the conical part are in interference fit, and the end surfaces of the connecting sleeve and the conical part are mutually flush.

13. The protective device of claim 1, wherein the protective cover assembly is slidable in an axial direction of the cannula assembly to radially compress the insertion instrument when the locking with the cannula assembly is released.

14. The protective device of claim 1, wherein the protective cover assembly comprises a front protective cover and a rear protective cover removably connected and collectively enclosing the receiving cavity, the front protective cover slidably connected to the sleeve assembly when unlocked from the sleeve assembly.

15. The protective apparatus of claim 14, wherein the front protective cover includes a slider within the receiving cavity, the slider protruding from an inner surface of the front cover and slidably engaging the sleeve assembly.

16. The protective device according to claim 14, wherein the front protective cover encloses a first front cavity, a second front cavity and a third front cavity which are sequentially arranged and configured as part of the accommodating cavity, the first front cavity and the second front cavity are both cylindrical and have a step surface therebetween, the caliber of the second front cavity is larger than that of the first front cavity, the caliber of the third front cavity is larger than or equal to that of the second front cavity, the first front cavity is matched with the sleeve component, the step surface is abutted with the sleeve component along the axial direction, and the caliber of the third front cavity is increased along the direction from the second front cavity to the third front cavity.

17. The protective device of claim 14, wherein the rear boot encloses and is configured as a first rear chamber and a second rear chamber of a portion of the receiving chamber, the first rear chamber being farther from the front boot than the second rear chamber when the front boot and rear boot are connected, the second rear chamber having a bore that is equal to or greater than a bore of the first rear chamber, the first rear chamber being cylindrical, the bore of the second rear chamber increasing in a direction from the first rear chamber toward the second rear chamber.

18. The protective device of claim 1, wherein the protective cover assembly comprises a front protective cover and a rear protective cover which are detachably connected and jointly enclose the accommodating cavity, a front air hole communicated with the accommodating cavity is formed in the front protective cover, a rear air hole communicated with the accommodating cavity is formed in the rear protective cover, and when the front protective cover and the rear protective cover are connected, the front air hole and the rear air hole are aligned and communicated with each other.

19. A medical device system comprising an implant device and a delivery system, wherein the medical device system further comprises a protective device according to any one of claims 1 to 18.