CN111821068B

CN111821068B - Connection release structure and system thereof

Info

Publication number: CN111821068B
Application number: CN201910405371.0A
Authority: CN
Inventors: 邱克劲; 吴永健; 赵轩铖; 刘鹏飞; 昌仁操; 刘小建; 张昱昕
Original assignee: Lepu Medical Technology Beijing Co Ltd
Current assignee: Lepu Medical Technology Beijing Co Ltd
Priority date: 2019-04-16
Filing date: 2019-05-16
Publication date: 2023-05-16
Anticipated expiration: 2039-05-16
Also published as: CN111821068A

Abstract

The invention discloses a connection release structure and a connection release system, wherein the connection release structure is used for connecting a release object and is arranged on a loading sheath tube, the connection release structure comprises a connection fixing system and an unlocking sleeve system, the connection fixing system comprises a hook structure, the unlocking sleeve system comprises an unlocking sleeve, the connection fixing structure and the unlocking sleeve are movably connected with the loading sheath tube, the connection fixing structure is used for being connected with the release object, and the unlocking sleeve is used for locking the connection fixing structure and the release object. The connecting and releasing structure and the connecting and fixing system provided by the invention can accurately control the stability and coaxiality of the valve stent in the releasing process, and effectively adjust the position of the valve stent or fully recover the valve stent in the implanting process so as to ensure that the valve has a good working state after being implanted.

Description

Connection release structure and system thereof

Technical Field

The invention relates to the technical field of medical appliances, in particular to a connection release structure for implanting a prosthetic valve stent into a mammalian body passageway and a system thereof.

Background

With the continuous extension of life span and the increasing trend of global population aging, the incidence of heart valve diseases is obviously increased, and in elderly patients, the incidence of heart valve diseases including the third place is as high as 13.3 percent, which is next to hypertension and coronary heart disease. Initially aortic valve disease was only treated by drug conservation, prosthetic heart valve replacement (surgical aorticvalve replacement, SAVR) occurred in the late 20 th century, and prosthetic valves were implanted in the body by surgical chest opening, thus there was also a requirement for the physical condition of the patient, and the risk of SAVR treatment was too great for patients at risk of advanced surgery, and was listed as contraindications. With the development of medical device technology, transcatheter heart valve replacement (transcatheter aortic valve replacement, TAVR) began to be used for treatment of patients at high risk in surgery in 2002 because of its advantages of no need for chest opening, low trauma, and quick recovery. The development of TAVR applies interventional technology to the valve field, brings good news to advanced high-risk patients with surgical contraindications, achieves good effects, is more and more concerned in the fields of cardiovascular disease research and treatment, and is highly desirable for a great number of patients with surgical high-risk senile degenerative valve diseases. In the last decade, a large number of new TAVR valve products are continuously developed worldwide, and through continuous research and development innovation and product iteration update, the TAVR valves approved for use in the market at present reach more than 10 families and are treated for more than 40 thousands of patients.

There is a kind of mechanical locking valve that can be fully recovered in the market at present, its valve support is woven by nickel titanium wire, then utilize unique locking/unlocking means to lock, its advantage can observe the operating condition of valve before accomplishing the release, if implant the condition is not ideal or operating condition is bad, can carry out complete recovery and take in the sheath, implant again or change the valve, but the shortcoming is that mechanical locking is more complicated, and is axial locking, too big oppression to valve annulus and left ventricle outflow tract, very easily causes the emergence of conduction block.

Disclosure of Invention

The present invention aims to overcome the drawbacks described in the prior art and thereby provide a connection release structure and system that improves the safety and reliability of the implant of the release.

In a first aspect, a connection release structure is provided for connecting a release, including connecting fixed system and unblock cover system, connect fixed system including connecting fixed structure, connect fixed structure and loading sheath swing joint, unblock cover system includes unblock sleeve pipe, unblock sleeve pipe and loading sheath swing joint, when connecting the release structure and being used for with the release is supporting, connect fixed structure and be used for being connected with the release, unblock sleeve pipe is used for fixed or unbuckled to connect fixed structure and release.

In one embodiment, the connection fixing structure may be one or more of a hook structure, a clip structure, or a lasso structure;

in one embodiment, the side of the connecting and fixing structure close to the loading sheath is a proximal side, and the side far away from the loading sheath is a distal side;

in one embodiment, the clip structure has an open state and a clip state;

in one embodiment, the clamping structure comprises a first clamp body and a second clamp body, wherein the proximal end side of the first clamp body is fixedly connected with the proximal end side of the second clamp body, and the first clamp body and the second clamp body are used for clamping and connecting a release object; preferably, when the clamping structure is in a clamping state, the distal end side of the first clamp body is abutted against the distal end side of the second clamp body, and when the clamping structure is in a disconnecting state, the distal end side of the first clamp body is disconnected from the distal end side of the second clamp body;

in one embodiment, the lasso structure has a contracted state and an expanded state;

in one embodiment, the attachment fixture is used to release or capture a release.

In one embodiment, in the storage state, the connection release structure is used for partially or completely storing the release object in the loading sheath;

In one embodiment, in the stowed state, the connection release structure is partially or fully stowed within the loading sheath;

in one embodiment, in the storage state, the connection fixing system and the unlocking sleeve system are partially or completely stored in the loading sheath;

in one embodiment, in the storage state, the connecting and fixing system and the unlocking sleeve system are partially or completely stored in the loading sheath tube,

in one embodiment, in the storage state, the connection fixing structure and the unlocking sleeve are partially or completely stored in the loading sheath.

In one embodiment, in the first state, the connection and fixation structure is configured to connect with a release; in the second state, the connecting and fixing structure is used for being disconnected with the release object;

in one embodiment, in the first state, the unlocking sleeve is used for being arranged at the joint of the connecting and fixing structure and the release object; or in the first state, the unlocking sleeve is close to the joint of the connecting and fixing structure and the release object.

In one embodiment, in the second state, the unlocking sleeve is not located at the connection of the connection fixture and the release.

In one embodiment, in the second state, the unlocking sleeve is moved away from the connection of the connection fixture and the release.

In one embodiment, the unlocking sleeve system comprises an outer tube arranged on the loading sheath, the outer tube is movably connected with the loading sheath, the tail end of the outer tube is provided with a second finger-shaped connecting rod, and the unlocking sleeve is arranged on the second finger-shaped connecting rod;

in one of the embodiments, the outer tube is snap-fit, magnetically coupled, rotatably coupled and/or slidably coupled, most preferably slidably coupled, to the loading sheath.

In one embodiment, the connection fixing system comprises an inner tube arranged on the loading sheath, the inner tube is movably connected with the loading sheath, the tail end of the inner tube is provided with a first finger-shaped connecting rod, and the connection fixing structures are arranged on the first finger-shaped connecting rods in a one-to-one correspondence manner; in one embodiment, the clip structure includes a first clip body having a proximal side connected to the first finger link and a second clip body having a proximal side connected to the first finger link; in one embodiment, in the first state, the distal side of the first clip body abuts the distal side of the second clip body; in one embodiment, in the second state, the distal side of the first clip body is disconnected from the distal side of the second clip body;

In one of the embodiments, the inner tube is snap-fit, magnetically, rotatably and/or slidingly connected, further preferably slidingly connected, to the loading sheath;

in one embodiment, the unlocking sleeves pass through the first finger links in a one-to-one correspondence;

in one embodiment, the inner tube is slidably connected to the outer tube;

in one embodiment, the sliding direction of the outer tube is the same as the sliding direction of the inner tube;

in one embodiment, the loading sheath is provided with a first through hole, and the first through hole is matched with the outer tube;

in one embodiment, a second through hole is arranged in the outer tube, the second through hole is matched with the inner tube, and the extending direction of the first through hole is the same as that of the first through hole;

in one embodiment, the first through hole and the second through hole are coaxially arranged;

in one embodiment, the connecting and fixing structures and the unlocking sleeve are arranged in equal quantity and are 3-18 in number; preferably 3-6, most preferably 3, or preferably 9-15, most preferably 12.

In a second aspect, a connection release system is provided, including connection fixed system, unblock cover system and release, connection fixed system is including connecting fixed structure, connection fixed structure and loading sheath swing joint, unblock cover system includes the unblock sleeve pipe, unblock sleeve pipe and loading sheath swing joint, connection fixed structure is connected with the release, unblock sleeve pipe locking connection fixed structure and release.

In one embodiment, in the stowed condition, the release material is partially or fully stowed within the loading sheath;

in one embodiment, in the stowed state, the connection release structure is partially or fully stowed within the loading sheath; more preferably, in the storage state, the connection fixing system and the unlocking sleeve system are partially or entirely stored in the loading sheath.

In one embodiment, in the first state, the connection fixation structure is connected with a release; in the second state, the connecting and fixing structure is disconnected from the release object;

in one embodiment, the unlocking sleeve is rectangular, circular or elliptical in cross section.

In one embodiment, the release is a self-expanding valve stent comprising a valve stent body;

In one embodiment, the self-expanding valve stent further comprises a hanging ear structure matched with the connection release system, and at least one end of the valve stent body is provided with the hanging ear structure;

in one embodiment, the valve stent body is a mesh tubular structure, and the length of the valve stent body is smaller than the diameter thereof;

in one embodiment, the valve stent body has a length of 18mm-30mm and a diameter of 18mm-35mm;

in one embodiment, part or all of the connecting and fixing structure is a hook structure, the hook structure and the hook structure are arranged in a snap fastener mode, the hook structure is omega-shaped, L-shaped, E-shaped, C-shaped or zigzag, and the shape of the hook structure is T-shaped, L-shaped, E-shaped, C-shaped or zigzag in sequence;

in one embodiment, in the second state, the unlocking sleeve is not located at the junction of the hook structure and the release;

in one embodiment, in the second state, the unlocking sleeve leaves the connection of the hook structure and the release;

In one embodiment, the length of the unlocking sleeve is greater than or equal to the length of the connection part of the hook structure and the release object;

in one embodiment, the unlocking sleeve mates or clearance fits with the release and the hook structure;

in one embodiment, in the first state, the unlocking sleeve is sleeved on the joint of the connecting and fixing structure and the release object; in one embodiment, in the first state, the unlocking sleeve is sleeved on the connection part of the hook structure and the release object, and the unlocking sleeve is matched or in clearance fit with the release object and the hook structure;

in one embodiment, part or all of the connecting and fixing structure is a lasso structure,

in one embodiment, in the first state, the hanger structure passes through the lasso structure, and the lasso structure is in a contracted state, and the lasso structure and the hanger structure are mutually clamped;

in one embodiment, in the first state, the unlocking sleeve is close to the connection of the lasso structure and the hanger structure;

in one embodiment, the lasso structure is in a contracted state;

In one embodiment, in the second state, the unlocking sleeve is far away from the connection of the lasso structure and the hanger structure; causing the lasso structure to be in an inflated state;

in one embodiment, the distal side of the lasso structure extends radially;

in one embodiment, the hanger structure is T-shaped, L-shaped, E-shaped, C-shaped or zigzag-shaped;

in one embodiment, part or all of the connecting and fixing structure is a clamping structure, and the clamping structure comprises a first clamping body and a second clamping body, and the proximal end side of the first clamping body is fixedly connected with the proximal end side of the second clamping body;

in one embodiment, in the first state, the first clamp and the second clamp a portion of the valve support body between the first clamp and the second clamp,

in one embodiment, in the first state, a first accommodating cavity is formed between the first clamp body and the second clamp body, and a part of the valve support body is positioned in the first accommodating cavity;

in one embodiment, in the second state, the first clamp body is disconnected from the second clamp body;

in one embodiment, in the second state, the distal side of the first clip body is separated from the distal side of the second clip body.

In a third aspect, a connection release system of a medical implant is provided, the connection release system is accommodated in a loading sheath, and comprises a hook system for connecting the medical implant and an unlocking sleeve system for locking or releasing the hook system and the medical implant, wherein the hook system and the unlocking sleeve system are arranged in the loading sheath in a relatively sliding manner from inside to outside, the hook system is provided with a hook structure for capturing the medical implant, and the unlocking sleeve system is provided with an unlocking sleeve, and when the hook structure is engaged with the medical implant, the unlocking sleeve is slid to a joint point to be locked under the action of external force or is slid away from the joint point to be released;

preferably, the hooking system comprises an inner tube coaxially arranged with the loading sheath, the tail end of the inner tube is provided with a first finger-shaped connecting rod, and the hooking structures are arranged on the finger-shaped connecting rods in a one-to-one correspondence manner;

preferably, the unlocking sleeve system comprises an outer tube sleeved outside the inner tube, the tail end of the outer tube is provided with a second finger-shaped connecting rod which is not less than the first finger-shaped connecting rod, and the unlocking sleeves correspondingly penetrate through the first finger-shaped connecting rod one by one and are arranged on the second finger-shaped connecting rod;

Preferably, the hook structures and the unlocking sleeve are arranged in an equal amount, and the number of the hook structures and the unlocking sleeve is 3-18.

Above-mentioned connection release structure and system thereof, when accomodating the state, accomodate in loading sheath intraductal, including connecting fixed system and unblock cover system, connect fixed system including connecting fixed structure, unblock cover system includes the unblock sleeve pipe, connect fixed structure with the unblock sleeve pipe slides and sets up on loading sheath pipe, connect fixed structure and be used for being connected with the release, the unblock sleeve pipe is used for locking connection fixed structure and release. By adopting the scheme, in the conveying process, the release object is connected with the connecting and fixing system and is locked through the unlocking sleeve, and after the release object and the connecting and fixing system reach the target position, the release object, the connecting and fixing system and the unlocking sleeve system are converted into an expansion state by moving the loading sheath tube to the near end and are supported to the target position; under the locking state of the unlocking sleeve, if the implantation position or the implantation state is found to be not ideal, the release object, the connecting and fixing system and the unlocking sleeve system can be partially or completely stored in the loading sheath again by moving the loading sheath to the far end, so that readjustment release is carried out or the whole system is withdrawn from the body, thereby providing fault tolerance opportunities for operators and improving the safety and reliability of implantation of the release object.

Drawings

In order to more clearly illustrate the embodiments of the invention or the technical solutions in the prior art, the drawings that are required in the embodiments or the description of the prior art will be briefly described, it being obvious that the drawings in the following description are only some embodiments of the invention, and that other drawings may be obtained according to these drawings without inventive effort for a person skilled in the art.

FIG. 1 is a schematic diagram of a connection release system and a release object of the present invention;

FIG. 2 is a schematic diagram of the structure of the present invention connecting the release system with the release locked state;

FIG. 3 is a schematic view of the configuration of a hooking system of one embodiment of the connection release system of the present invention;

FIG. 4 is a schematic diagram of the configuration of an unlocking sleeve system of one embodiment of the connection release system of the present invention;

FIG. 5 is a schematic illustration of the structure of a valve stent in one embodiment of the present invention;

FIG. 6 is a schematic illustration of the structure of a valve stent in another embodiment of the present invention;

FIG. 7 is a schematic illustration of one attachment form of the hanger structure to the hook structure of the present invention;

FIG. 8 is a schematic view of another connection between the hanger structure and the hook structure in accordance with the present invention;

FIG. 9 is a schematic view of yet another connection of the hanger structure to the hook structure of the present invention;

FIG. 10 is a schematic view of yet another connection of the hanger structure to the hook structure of the present invention;

FIG. 11 is a schematic view of yet another connection of the hanger structure to the hook structure of the present invention;

FIG. 12 is a schematic illustration of one form of attachment (not clamped) of the clip structure to the valve holder body of the present invention;

FIG. 13 is a schematic view of a connection (clamped) of the clip structure to the valve holder body of the present invention;

FIG. 14 is a schematic view of a connection (not clamped) between the clip structure and the valve holder body of the present invention;

FIG. 15 is a schematic view of a connection (clamped) of the clip structure to the valve holder body of the present invention;

FIG. 16 is a partial schematic view of one form of attachment of the lasso structure to the hanger structure (contracted state) of the present invention;

FIG. 17 is a partial schematic view of one form of attachment of the lasso structure to the hanger structure (expanded state) of the present invention;

FIG. 18 is a schematic illustration of one form of attachment of the lasso structure to the hanger structure (contracted state) of the present invention;

FIG. 19 is a schematic view of a connection between a lasso structure and a hanger structure (expanded state) according to the present invention;

FIG. 20 is a schematic view of a valve stent of the present invention partially open when implanted in a body via the apical path;

FIG. 21 is a schematic view of the valve holder of FIG. 20 fully open;

FIG. 22 is a schematic view of the valve stent after withdrawal and release of the unlocking sleeve system of FIG. 20;

FIG. 23 is a schematic view of the connection release system of FIG. 20 disengaged from the valve holder;

FIG. 24 is a schematic view of the valve holder of FIG. 20 secured in position in an annulus;

FIG. 25 is a schematic view of a valve stent of the present invention partially open when implanted in a body via the femoral artery path;

FIG. 26 is a schematic view of the valve holder of FIG. 25 fully open;

FIG. 27 is a schematic view of the valve stent of FIG. 25 after withdrawal of the unlocking sleeve system;

FIG. 28 is a schematic view of the attachment release system of FIG. 25 detached from the valve stent;

fig. 29 is a schematic view of the valve holder of fig. 25 secured in position in the annulus.

The marks in the figure are as follows: 100. a release; 101. a valve stent body; 102. a hanging ear structure; 104. an inflow end of the valve stent; 105. an outflow end of the valve stent; 200. a connection release structure; 201. connecting a fixing system; 2011. connecting and fixing the structure; 2012. a first finger link; 2013. an inner tube; 202. an unlocking sleeve system; 2021. unlocking the sleeve; 2022. a second finger link; 2023. an outer tube; 300. loading a sheath; 401. an annulus position; 402. original leaflet; 403. a left ventricle; 404. apex of heart; 406. the aorta.

Detailed Description

The following description of the embodiments of the present invention will be made apparent and fully in view of the accompanying drawings, in which some, but not all embodiments of the invention are shown. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.

In the description of the present invention, it should be noted that the directions or positional relationships indicated by the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc. are based on the directions or positional relationships shown in the drawings, are merely for convenience of describing the present invention and simplifying the description, and do not indicate or imply that the devices or elements referred to must have a specific orientation, be configured and operated in a specific orientation, and thus should not be construed as limiting the present invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance.

In the description of the present invention, it should be noted that, unless explicitly specified and limited otherwise, the terms "mounted," "connected," and "connected" are to be construed broadly, and may be either fixedly connected, detachably connected, or integrally connected, for example; can be mechanically or electrically connected; can be directly connected or indirectly connected through an intermediate medium, and can be communication between two elements. The specific meaning of the above terms in the present invention will be understood in specific cases by those of ordinary skill in the art.

In addition, the technical features of the different embodiments of the present invention described below may be combined with each other as long as they do not collide with each other.

As used in this disclosure and the appended claims, the singular forms "a," "an," and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It should also be understood that the term "and/or" as used herein refers to and encompasses any or all possible combinations of one or more of the associated listed items.

In this disclosure and the appended claims, "plurality" and "plurality" refer to two or more unless otherwise specified.

Example 1

One embodiment of a connection release structure 200 is shown in fig. 1-2 for connecting a release 100, more precisely, for capturing and releasing the release 100. The unlocking sleeve system 202 comprises an unlocking sleeve 2021, the unlocking sleeve 2021 is movably connected with the loading sheath 300, when the connection and release structure is used for being matched with a release, the connection and fixation structure 2011 is used for being connected with the release 100, and the unlocking sleeve 2021 is used for locking the connection and fixation structure 2011 and the release 100.

Although the connection fixing structure is a hook structure in the present embodiment, it may be one or more of a lasso structure, a clip structure, or a hook structure.

In one possible embodiment, in the stowed state, the release 100 is partially or fully stowed within the loading sheath 300; in one possible embodiment, in the stowed state, the connection release structure is partially or fully stowed within the loading sheath 300; in one possible embodiment, in the storage state, the connection fixing system 201 and the unlocking sleeve system 202 are partially or completely stored in the loading sheath.

By adopting the above scheme, the release 100 can be captured by the connection fixing structure 2011 of the connection fixing system 201, then the sleeve in the unlocking sleeve system 202 is moved to the connection position of the connection fixing structure 2011 and the release 100 under the action of external force, the connection fixing structure 2011 and the release 100 are locked to avoid separation of the connection fixing structure 2011 and the release 100 due to the action of external force, the locked connection fixing structure 2011 and the release 100 can be fixed together, the release 100, such as a prosthetic heart valve, is conveyed to a designated area, such as an aortic valve 406 valve area, to be opened by the femoral artery through the transcatheter technology, the release 100, such as a prosthetic heart valve, is connected with the connection fixing system 201 and is tightly sleeved by the unlocking sleeve 2021 in the unlocking sleeve system 202 in the conveying process, so that the locked connection fixing structure 2011 and the release 100 can be adjusted multiple times without causing separation of the connection fixing structure 2011 and the release 100 (namely, the release 100 can be unfolded multiple times to release the release 100, so as to obtain the most suitable unfolding mode and implantation position), the release position) is improved, the release position of the release 100, such as an artificial heart valve is conveyed to the designated area, such as an aortic valve is opened, and the release position is exactly by the release sleeve, and the release position can be adjusted by pulling the release sleeve, and the release position is released by the release position.

In one possible embodiment, in the storage state, the connection fixing system 201 and the unlocking sleeve system 202 are partially or completely stored in the loading sheath 300, and more preferably, in the storage state, the connection fixing structure 2011 and the unlocking sleeve 2021 are partially or completely stored in the loading sheath 300. Because the connection release structure 200 can be stored in the loading sheath 300, even if the release 100 cannot be placed at a proper position due to various factors, the connection release structure 200 (i.e., the connection fixing structure 2011 and the unlocking sleeve 2021 can be partially or completely stored in the loading sheath 300, and meanwhile, the release 100 connected with the connection fixing structure 2011 can be changed into a contracted state and can be partially or completely stored in the loading sheath 300, so that the recovery of the loading sheath 300 is not hindered, the complete recovery of the loading sheath 300 is facilitated, fault tolerance opportunities are provided for operators, and the safety and reliability of the implantation of the release 100 are improved.

In one possible embodiment, the attachment fixture is used to release or capture a release.

Specifically, in the first state, the connection fixing structure 2011 is configured to connect with the release object 100, and the unlocking sleeve 2021 is sleeved on a connection position between the connection fixing structure 2011 and the release object 100; in the second state, the connection fixation structure 2011 is configured to be disconnected from the release 100. More specifically, in the second state, the unlocking sleeve 2021 is not located at the connection of the connection fixation structure 2011 and the release 100; more precisely, in the second state, the unlocking sleeve 2021 is separated from the connection between the connection fixing structure 2011 and the release object 100, and the connection fixing structure 2011 and the release object 100 are not locked, so that the connection fixing structure 2011 can be disconnected from the release object 100 under the action of external force, and the release object 100 is released.

In one possible embodiment, as shown in fig. 4, the unlocking sleeve system 202 includes an outer tube 2023 disposed on the loading sheath 300, the outer tube 2023 being slidably connected to the loading sheath 300, the outer tube 2023 having a second finger link 2022 at a distal end thereof, and the unlocking sleeve 2021 being disposed on the second finger link 2022. Specifically, as shown in fig. 4, the unlocking sleeve system 202 has an unlocking sleeve 2021, the guiding portion of the unlocking sleeve system 202 is substantially the same as that of the connection fixing system 201, that is, a guiding portion is formed by an outer tube 2023 and a second finger link 2022, the outer tube 2023 is sleeved outside the inner tube 2013 and can be received in the loading sheath 300, the second finger link 2022 sequentially combines the unlocking sleeve 2021 and the outer tube 2023 into a whole, wherein the number of the second finger links 2022 is greater than or equal to that of the first finger links 2012, and the unlocking sleeve 2021 penetrates the first finger links 2012 one by one and is disposed on the second finger links 2022. That is, the solution can introduce the release into the body through the loading sheath, and by applying a force to the end of the outer tube away from the unlocking sleeve, the unlocking sleeve is slid, so that the unlocking sleeve 2021 no longer locks the connection fixing structure 2011 with the release 100.

In one possible embodiment, to enable the unlocking sleeve system 202 to be partially or fully received into the loading sheath 300, the unlocking sleeve system 202 may be received into the loading sheath 300 in a manner that allows the unlocking sleeve system 202 to move relative to the loading sheath 300. More specifically, a second connector is provided between the second finger link 2022 and the outer tube 2023, which may be received into the loading sheath 300 in a manner that allows the unlocking sleeve system 202 to move relative to the loading sheath 300. For example, in some embodiments, the second connector may be configured to allow the second finger link 2022 to rotate relative to the outer tube 2023 about the connector. In some embodiments, the second connector may provide a rotational connection between the second finger link 2022 and the outer tube 2023. In some embodiments, the second connector may provide a flexible attachment between the second finger link 2022 and the outer tube 2023. As described herein with reference to various embodiments of the prosthetic valve, the second connector can be of various different types and configurations. For example, the second connector may include a living hinge, a flexible member, a suture wrapped through an opening, a pin or tab inserted through an opening, or any combination thereof. In some embodiments, the second connector is a memory metal or alloy.

In one possible embodiment, the connection fixing system 201 includes an inner tube 2013 disposed on the loading sheath 300, the inner tube 2013 is slidably connected to the loading sheath 300, the end of the inner tube 2013 has a first finger link 2012, the connection fixing structure 2011 is disposed on the first finger link 2012 in a one-to-one correspondence, and the unlocking sleeve 2021 passes through the first finger link 2012 in a one-to-one correspondence, specifically, the inner tube 2013 is slidably connected to the outer tube 2023, and the sliding direction of the outer tube 2023 is the same as the sliding direction of the inner tube 2013. Specifically, as shown in fig. 3, which is a schematic structural diagram of the connection fixing system 201, the connection fixing system 201 is formed by sequentially combining a connection fixing structure 2011, a first finger-shaped connecting rod 2012 and an inner tube 2013 coaxially arranged with the loading sheath 300, the inner tube 2013 is used as a stress collecting point, and is more easily accommodated in the loading sheath 300, and the connection fixing structure 2011 is connected to the inner tube 2013 by the rigid first finger-shaped connecting rod 2012, so that the coaxiality of the inner tube 2013 and the connection fixing structure 2011 can be ensured, the subsequent transmission and release can be completed better, and finally the stable butt joint between the connection fixing structure 2011 and the release 100 can be performed. In the above-described aspect, the connecting fixing structure may be slid by applying a force to an end of the inner tube remote from the connecting fixing structure, so that the connecting fixing structure 2011 is disconnected from the release material 100, thereby releasing the release material.

In one possible embodiment, to enable the connection fixation system 201 to be partially or fully received into the loading sheath 300, the connection fixation system 201 may be received into the loading sheath 300 in a manner that allows the connection fixation system 201 to move relative to the loading sheath 300. More specifically, a first connector is provided between the first finger link 2012 and the inner tube 2013, which can be received into the loading sheath 300 in a manner that allows the first finger link 2012 to move relative to the loading sheath 300. For example, in some embodiments, the first connector may be configured to allow the first finger link 2012 to rotate about the connector relative to the inner tube 2013. In some embodiments, a first connector may provide a rotational connection between first finger link 2012 and inner tube 2013. In some embodiments, the connector may provide a flexible attachment between the second finger link 2022 and the inner tube 2013. As described herein with reference to various embodiments of the prosthetic valve, the first connector can be of various different types and configurations. For example, the first connector may include a living hinge, a flexible member, a suture wrapped through an opening, a pin or tab inserted through an opening, or any combination thereof. In some embodiments, the first connector is a memory metal or alloy.

In one possible embodiment, the inner tube 2013 is slidably connected to the outer tube 2023, and preferably, the sliding direction of the outer tube 2023 is the same as the sliding direction of the inner tube 2013. More precisely, the loading sheath 300 is provided with a first through hole, which is matched with the outer tube 2023, while the outer tube 2023 is provided with a second through hole, which is matched with the inner tube 2013, and which extends in the same direction as the first through hole. The sliding direction of the outer tube 2023 and the sliding direction of the inner tube 2013 are set to be the same, so that coaxiality between the connecting and fixing structure 2011 and the unlocking sleeve 2021 in the sliding process is guaranteed, stability of the valve stent in the releasing process is guaranteed, the valve stent can be better unfolded and released, and the situation that the valve stent part is fully stretched and the other part cannot be fully unfolded is avoided. Meanwhile, since the outer tube 2023 and the inner tube 2013 are both disposed in the loading sheath 300, the operator can conveniently pull the inner tube 2013 and the outer tube 2023 to partially or completely receive the unlocking sleeve system 202 and the connection fixing system 201 in the loading sheath 300.

It should be appreciated that in some embodiments, the unlocking sleeve 2021 is snap-fit, rotation, or magnetic with the loading sheath 300. In some embodiments, the unlocking sleeve system 202 comprises an outer tube 2023 disposed on the loading sheath 300, the outer tube 2023 is movably connected to the loading sheath 300, a second finger link 2022 is disposed at the end of the outer tube 2023, and the unlocking sleeve 2021 is disposed on the second finger link 2022. The outer tube 2023 is snap-fit, rotationally or magnetically connected to the loading sheath 300. As in some embodiments, the loading sheath 300 is provided with several snap features for securing the outer tube 2023, by which the user may choose to secure the outer tube 2023 in different positions. Alternatively, in some embodiments, the loading sheath 300 and the outer tube 2023 are provided with mating threads, and the loading sheath 300 and the outer tube 2023 are screwed together.

In some embodiments, the unlocking sleeve 2021 is snap-fit, rotation, or magnetic with the loading sheath 300.

The connection fixing system 201 includes an inner tube 2013 disposed on the loading sheath 300, the inner tube 2013 is movably connected to the loading sheath 300, a first finger link 2012 is disposed at an end of the inner tube 2013, the connection fixing structure 2011 is disposed on the first finger link 2012 in a one-to-one correspondence, and the unlocking sleeve 2021 passes through the first finger link 2012 in a one-to-one correspondence. The inner tube 2023 is snap-fit, rotatably connected, or magnetically connected to the loading sheath 300. More precisely, in the present embodiment, the inner tube 2023 is movably connected to the outer tube 2013, and the outer tube 2013 is movably connected to the loading sheath 300, so that the inner tube 2023 is movably connected to the loading sheath 300. As in some embodiments, the outer tube 2023 is provided with several snap features for securing the inner tube 2013, by which a user may choose to secure the inner tube 2013 in different positions.

It should be appreciated that in addition to the embodiment described above in which the loading sheath 300 is sleeved over the outer tube 2023, the outer tube 2023 may be sleeved over the inner tube 2013, other designs may be provided in which the outer tube 2023 is sleeved over the loading sheath 300, the inner tube 2013 may be sleeved over the outer tube 2023, and so on. As long as it is satisfied that both the inner tube 2013 and the outer tube 2023 are movably provided on the loading sheath 300.

In one embodiment, the unlocking sleeve 2021 is provided with a third through hole that mates with the first finger link 2012 such that the unlocking sleeve 2021 can slide along the first finger link 2012. More precisely, the unlocking sleeve 2021 as shown in fig. 4 is a hollow sleeve whose cross-sectional shape is rectangular, circular and oval, preferably rectangular, to better control the stability and coaxiality of the above-described solution transmissions.

In one possible embodiment, the number of the connection fixing structures 2011 is 3-18, which is equal to the number of the unlocking sleeves 2021. When 3, three connection fixing structures 2011 are uniformly connected at the periphery of the release 100 to form a stable triangle structure, so that the stability and the coaxiality of the transmission of the invention are ensured, the number of the connection fixing structures 2011 is set to be not more than 18 in consideration of the limitation of the femoral artery diameter and the convenience of operation, the number of the connection fixing structures 2011 is most preferably 12 according to the multiple practices of the inventor, and naturally, the number of the first finger-shaped connecting rods 2012 and the connection fixing structures 2011 are always equal because the first finger-shaped connecting rods 2012 play a role of connecting the connection fixing structures 2011 and the inner tube 2013. While the second finger link 2022 functions to connect the unlocking sleeve 2021 and the outer tube 2023, the number of the second finger links 2022 and the unlocking sleeve 2021 and the connection fixing structure 2011 are always equal. The unlocking sleeve 2021 of the unlocking sleeve system 202 shown in fig. 4 is a hollow sleeve having a cross-sectional area shaped as a rectangle, a circle, and an oval, preferably a rectangle, to better control the stability and coaxiality of the inventive transmission.

Example 2

Unlike embodiment 1, this embodiment provides a connection release system comprising a connection fixing system 201, an unlocking sleeve system 202 and a release 100, wherein the connection fixing system 201 comprises a connection fixing structure 2011, the connection fixing structure 2011 is movably connected, preferably slidingly connected, with the loading sheath 300, and the unlocking sleeve system 202 comprises an unlocking sleeve 2021, and the unlocking sleeve 2021 is movably connected, preferably slidingly connected, with the loading sheath 300; the connecting and fixing structure 2011 is connected with the release 100, and the unlocking sleeve 2021 locks the connecting and fixing structure 2011 with the release 100.

In some embodiments, the unlocking sleeve 2021 is snap-fit, magnetically, or slidingly coupled to the loading sheath 300.

In some embodiments, the unlocking sleeve 2021 is snap-fit, magnetically, or slidingly coupled to the loading effect 300.

In one possible embodiment, in the first state, the connection fixing structure 2011 is connected to the release object 100, and the unlocking sleeve 2021 is sleeved on a connection part between the connection fixing structure 2011 and the release object 100; in the second state, the connection fixation structure 2011 is disconnected from the release 100.

In one possible embodiment, in the second state, the unlocking sleeve 2021 is not located at the connection between the connection fixing structure 2011 and the release object 100, and the connection fixing structure 2011 and the release object 100 are not locked;

in one possible embodiment, in the second state, the unlocking sleeve 2021 is separated from the connection of the connection fixation structure 2011 and the release 100.

In one possible embodiment, in the storage state, the connection fixing system 201 and the unlocking sleeve system 202 are partially or completely stored in the loading sheath 300, and more preferably, in the storage state, the connection fixing structure 2011 and the unlocking sleeve 2021 are partially or completely stored in the loading sheath 300.

In one possible embodiment, the length of the unlocking sleeve 2021 is greater than or equal to the length of the connection portion between the connection fixing structure 2011 and the release 100.

In one possible embodiment, the unlocking sleeve 2021 is in clearance fit with the release 100 and the connecting fixation structure 2011;

in one possible embodiment, in the first state, the unlocking sleeve 2021 is sleeved on the connection between the connection fixing structure 2011 and the release object 100, and the unlocking sleeve 2021 is in clearance fit with the release object 100 and the connection fixing structure 2011.

In one possible embodiment, the unlocking sleeve 2021 is rectangular, circular, or oval in cross-section.

In one possible embodiment, the release 100 is a self-expanding valve stent, which comprises a valve stent body 101 and a hanging structure 102 cooperating with the connection release system, at least one end of the valve stent body 101 is provided with the hanging structure 102.

In one possible embodiment, the valve stent body 101 is a mesh-like structure, and the length of the valve stent body 101 is smaller than the diameter thereof.

In one possible embodiment, the valve stent body 101 has a length of 18mm-30mm and the valve stent body 101 has a diameter of 18mm-35mm.

In one possible embodiment, the ear hanging structure 102 and the connecting and fixing structure 2011 are arranged in a snap-fastener manner, the connecting and fixing structure 2011 is in an Ω -shape, an L-shape, an E-shape, a C-shape or a zigzag shape, and the shape of the ear hanging structure 102 is in a T-shape, an L-shape, an E-shape, a C-shape or a zigzag shape in sequence.

In one possible embodiment, as shown in fig. 5, the structure of the first release article 100 in this embodiment is a schematic view, in this embodiment, the release article 100 is preferably a valve stent, preferably a self-expanding valve stent, that is, the valve stent has a contracted state and an expanded state, the valve stent in the expanded state is formed by cutting a super-elastic alloy material or a shape memory alloy material, the valve stent includes a valve stent body 101 and a hanging ear structure 102, the valve stent body 101 is in a webmaster structure, the webmaster structure is formed by connecting a plurality of diamond-shaped grid structures, at least one end of each diamond-shaped grid is provided with a hanging ear structure 102 matched with a connection release system, the hanging ear structure 102 of the valve stent is formed by extending the tail end of each diamond-shaped grid, and in the embodiment shown in fig. 5, the hanging ear structure 102 of the valve stent is an extension of the webmaster structure at the outflow end 105 of the valve stent, and can be implanted through a femoral artery path by connecting with a connection fixing structure 2011 of the connection release system.

In one embodiment, the second configuration of the valve stent 100 can be as shown in fig. 6, where the hanging structure 102 of the valve stent 100 is an extension of the mesh tubular structure 101 at the inflow end 104 of the valve stent, and the transapical path implantation can be achieved by connecting with a connecting fixation structure of the connection release system 200.

In one embodiment, the valve stent is preferably 18mm-30mm in length, 18mm-35mm in diameter, and less than it is, to ensure that the valve stent used with the connection release system does not occlude the coronary ostium after implantation and does not significantly cause conduction block.

In one embodiment, as shown in fig. 7-11, a schematic view of various connection forms of the valve stent tab structure 102 and the connection fixation structure 2011 of the connection fixation system 201. It can be understood by those skilled in the art that, in order to realize the matching hooking function of the connection fixing structure 2011 and the hanging structure 102, the connection fixing structure 2011 and the hanging structure may be formed as a whole in the form of a snap fastener, and the shapes of the connection fixing structure and the hanging structure include, but are not limited to, for example, fig. 7 shows the connection form of the T-shaped hanging structure 102 and the Ω -shaped connection fixing structure 2011, fig. 8 shows the connection form of the L-shaped hanging structure 102 and the L-shaped connection fixing structure 2011, fig. 9 shows the connection form of the E-shaped hanging structure 102 and the E-shaped connection fixing structure 2011, fig. 10 shows the connection form of the C-shaped hanging structure 102 and the C-shaped connection fixing structure 2011, and fig. 11 shows the connection form of the zigzag hanging structure 102 and the zigzag connection fixing structure 2011.

As shown in fig. 1, a schematic diagram of a state of conversion after the connection fixing structure 2011 in the connection release system 200 is connected to the hanging tab structure 102 of the valve stent 100 is shown in fig. 2, a schematic diagram of a state of conversion after the valve stent 100 is locked by the unlocking sleeve system 202 in the connection release system 100, and the valve stent 100 and the connection release system 200 in this embodiment of the invention can be stored in the loading sheath 300 in a storage state after being connected.

In order to ensure that the unlocking sleeve 2021 covers the hanging ear structure 102 and the connection fixing structure 2011 in the length direction, in one possible embodiment, the length of the unlocking sleeve is greater than or equal to the length of the connection fixing structure and the release object. It should be appreciated that in a particular implementation, the cross-sectional size and length of the unlocking sleeve 2011 may be adjusted and preferred according to the cross-sectional size and length of the hanger structure 102 and the connection fixation structure 2011.

In one possible embodiment, the unlocking sleeve 2021 mates with or is clearance fit with the release 100 and the connection securement structure 201;

in one possible embodiment, in the first state, the unlocking sleeve 2021 is sleeved on the connection between the connection fixing structure 201 and the release object 100, the unlocking sleeve 2021 is matched or clearance-matched with the release object 100 and the connection fixing structure 201, more precisely, the third through hole of the unlocking sleeve 2021 is matched with the hanging structure 102 and the connection fixing structure 201.

By setting the cross-sectional area size of the unlocking sleeve 2021 (third through hole) to be equal to or larger than the cross-sectional area size of the joint formed by the hooking of the hanging lug structure 102 in the valve stent 100 and the connecting fixing structure 2011 in the connecting fixing system 201, it is ensured that the unlocking sleeve 2021 can cover the joint of the hanging lug structure 102 and the connecting fixing structure 2011, and meanwhile, when the unlocking sleeve 2021 is positioned at the joint, the two are tightly matched, so that the unlocking sleeve 2021 can cover the hanging lug structure 102 and the connecting fixing structure 2011, and shaking in the cross-section direction of the unlocking sleeve 2021 does not occur at the same time.

As shown in fig. 20-24, the present invention provides a schematic representation of a procedure for implanting a valve stent and a connection release system via a transapical approach:

the method comprises the following steps: the first valve stent 100 and the connection release system 200 are connected and then loaded into the loading sheath 300, and the loaded valve stent is delivered to the annular position 401 via the left ventricle 403 by opening the apex 404, and the loading sheath 300 is slowly pulled back to release a portion of the valve stent 100, so that the valve stent 100 expands the original valve leaflet 402 due to the superelastic and shape memory properties of the valve stent material, as shown in fig. 20. The loading sheath 300 is then continued to be withdrawn, and the valve stent 100 and the connection release system 200 are fully released open, assuming an expanded state, as shown in fig. 21. At this point the valve holder 100 fully supports the annulus position 401, at which point the operator can observe the implantation site, operation, etc. of the prosthetic valve in the body. When the operator determines that the implantation position is appropriate and the working condition is good, the operator controls the outer tube 2023 of the unlocking sleeve system 202, so that the outer tube 2023 moves proximally relative to the inner tube 2013 of the connection fixing system 201, and the outer tube 2023 drives the unlocking sleeve 2021 to also move proximally through the unlocking sleeve connecting rod 2022, so that the hanging tab structure 102 of the valve stent 100 and the connection fixing structure 2011 of the connection fixing system 201 are exposed, and at this time, the hanging tab structure 102 and the connection fixing system 2011 are not covered by the unlocking sleeve 2021 any more, as shown in fig. 22. The attachment release system 200 and the post-implantation valve stent 100 are then secured in the annulus position 401 by gently rotating or rocking the attachment release system 200, as shown in fig. 23. The connection release system 200 is then withdrawn from the body and the valve stent 100 is fully implanted, as shown in fig. 24. It should be understood that the proximal end is the end of the outer tube remote from the unlocking sleeve.

Conversely, after the implantation process has proceeded to, for example, fig. 21, the operator may find out an improper implantation site or an undesirable operation before the unlocking sleeve system 202 is moved proximally, at which time the valve holder 100 may be readjusted to the implantation site or the valve replaced by controlling the relative movement of the connection release system 200 and the loading sheath 300 to readjust the valve holder into the loading sheath 300.

As shown in fig. 25-29, the present invention also provides a schematic representation of a procedure for implanting a valve stent and a connection release system via the femoral artery path:

specifically: the second valve stent 100 and the connection release system 200 are first loaded into the loading sheath 300, and after the loaded valve is delivered to the annulus position 401 via the aorta 406, the loading sheath 300 is slowly retracted back to release a portion of the valve stent 100, and the valve stent 100 struts the original leaflets 402 due to the superelastic and shape memory properties of the valve stent material, as shown in fig. 25. The loading sheath 300 is then continued to be withdrawn, and the valve stent 100 and the connection release system 200 are fully released open, assuming an expanded state, as shown in fig. 26. At this point the valve holder 100 fully supports the annulus position 401, at which point the operator can observe the implantation site, operation, etc. of the prosthetic valve in the body. When the operator determines that the implantation position is appropriate and the working condition is good, the operator controls the outer tube 2023 of the unlocking sleeve system 202, so that the outer tube 2023 moves proximally relative to the inner tube 2013 of the connection fixing system 201, and the outer tube 2023 drives the unlocking sleeve 2021 to also move proximally through the unlocking sleeve connecting rod 2022, so that the hanging tab structure 102 of the valve stent 100 and the connection fixing structure 2011 of the connection fixing system 201 are exposed, and at this time, the hanging tab structure 102 and the connection fixing system 2011 are not covered by the unlocking sleeve 2021 any more, as shown in fig. 27. The attachment release system 200 and the post-implantation valve stent 100 are then secured in the annulus position 401 by gently rotating or rocking the attachment release system 200, as shown in fig. 28. The connection release system 200 is then withdrawn from the body and the valve stent is fully implanted, as shown in fig. 29. Conversely, after the implantation process has been performed as shown in fig. 26, if the operator finds that the implantation site is not suitable or is not operating properly before the unlocking sleeve system 202 is moved proximally, the operator can also readjust the implantation site or replace the valve by controlling the relative movement of the connection release system 200 and the loading sheath 300 to re-receive the valve stent 100 into the loading sheath 300.

Example 3

In this embodiment, the connecting and fixing structure 2011 is a lasso structure, and the connecting and fixing structure 2011 will be replaced by a lasso structure, it should be understood that the side of the connecting and fixing structure 2011 close to the loading sheath 300 is the proximal side of the connecting and fixing structure 2011 (lasso structure), and the side far from the loading sheath 300 is the distal side of the connecting and fixing structure 2011 (lasso structure);

in the first state, the connecting and fixing structure 2011 (lasso structure) is connected to the release 100; in the second state, the connecting and fixing structure 2011 (lasso structure) is disconnected from the release 100;

in one embodiment, in the first state, the hanger structure 102 passes through the lasso structure, and the lasso structure is in a contracted state, and the lasso structure and the hanger structure 102 are clamped with each other;

in one embodiment, in the first state, the unlocking sleeve 2021 is proximate to the junction of the lasso structure and the hanger structure 102 such that the lasso structure is in a contracted state;

in one embodiment, in the second state, the unlocking sleeve 2021 is distal from the junction of the lasso structure and the hanger structure 102; causing the lasso structure to be in an inflated state;

In one embodiment, the distal side of the lasso structure extends radially; since the distal side of the lasso structure extends radially, when the unlocking sleeve 2021 is moved distally, it will rest on the distal side of the lasso structure, will not directly disengage the lasso structure, and may also be brought into a contracted state.

In one embodiment, the ear structures 102 are T-shaped, L-shaped, E-shaped, C-shaped, or zigzag shaped.

In one embodiment, some or all of the lasso structure has superelastic and shape memory properties.

Specifically, initially, the lasso structure is in an expanded state, the front end of the hanger structure 102 may pass through the lasso structure, then the operator may control the outer tube 2023 of the unlocking sleeve system 202 to move the outer tube 2023 distally relative to the inner tube 2013 of the connection fixing system 201, and the outer tube 2023 drives the unlocking sleeve 2021 to move distally through the unlocking sleeve connecting rod, that is, the unlocking sleeve 2021 approaches to the connection between the lasso structure and the hanger structure 102, so that the lasso structure is in a contracted state, and the front end of the hanger structure 102 cannot pass back through the lasso structure, thereby the hanger structure 102 is clamped with the lasso structure. (i.e. the first state)

After the operator completes the implantation of the valve and determines that the implantation position is proper and the working condition is good, the operator can control the outer tube 2023 of the unlocking sleeve system 202 to enable the outer tube 2023 to move proximally relative to the inner tube 2013 connected with the fixing system 201, and the outer tube 2023 drives the unlocking sleeve 2021 to also move proximally through the unlocking sleeve connecting rod, namely the unlocking sleeve 2021 is far away from the joint of the lasso structure and the hanging lug structure 102; as a result of no further force being applied to the unlocking sleeve 2021, the contracted lasso structure expands back such that it is in an expanded state. At this point (i.e., the second state), the front end of the suspension loop structure 102 may be passed back through the lasso structure, and then the connection release system and the implanted valve stent may be completely unloaded and secured in the annulus position 401 by gently rotating or rocking the connection release system.

Example 4

To better illustrate how the connection and fixation structure 2011 is connected and fixed with the release 100 when the connection and fixation structure 2011 is a clip structure, the applicant also provides this embodiment. In this embodiment, the connection fixing structure 2011 is a clip structure; the connection fixing structure 2011 will be replaced with a clip structure hereinafter.

The side of the connecting and fixing structure 2011, which is close to the loading sheath 300, is a proximal side, and the side, which is far away from the loading sheath 300, is a distal side;

preferably, the clamping structure has an off state and a clamping state;

preferably, the clamping structure comprises a first clamping body and a second clamping body, wherein the proximal end side of the first clamping body is fixedly connected with the proximal end side of the second clamping body, and the first clamping body and the second clamping body are used for clamping and connecting the release object 100; it should be understood that the meaning of the proximal side and the distal side of the first clip body and the second clip body is the same as the meaning of the proximal side and the distal side of the connection fixing structure 2011, and the side close to the loading sheath 300 is the proximal side and the side far from the loading sheath 300 is the distal side; preferably, when the clamping structure is in a clamping state, the distal end side of the first clamp body is abutted against the distal end side of the second clamp body, and when the clamping structure is in a disconnecting state, the distal end side of the first clamp body is disconnected from the distal end side of the second clamp body;

preferably, in the first state, the first clamp and the second clamp a part of the valve support body 101 between the first clamp and the second clamp;

preferably, in the first state, a first cavity is formed between the first clamp body and the second clamp body, and a part of the valve support body 101 is located in the first cavity; it should be understood that the valve support body 101 is a mesh tube structure, on which there are several strips for forming the mesh tube structure, and the first cavity is matched with the strips.

Preferably, in the second state, the first clamp body is disconnected from the second clamp body;

preferably, in the second state, the distal end side of the first clip body is separated from the distal end side of the second clip body.

In one embodiment, the partial or complete clip structure has superelastic and shape memory properties, in some embodiments a memory metal or alloy.

Specifically, at first, the first clamp body and the second clamp body in the clamping structure are disconnected, the strip-shaped object in the valve support body 101 may be placed in the first clamp body and the second clamp body, then the operator may control the outer tube 2023 of the unlocking sleeve system 202 to make the outer tube 2023 move distally relative to the inner tube 2013 of the connection fixing system 201, and the outer tube 2023 drives the unlocking sleeve 2021 to move distally through the unlocking sleeve connecting rod, that is, the unlocking sleeve 2021 approaches to the connection position between the clamping structure and the valve support body 101, so that the clamping structure is in a clamped state, and the distal end side of the first clamp body abuts against the distal end side of the second clamp body, so that the valve support body 101 (strip-shaped object) is clamped between the first clamp body and the second clamp body, and the valve support body 101 is clamped together with the connection fixing structure 2011. (i.e. the first state)

After the operator completes the implantation of the valve and determines that the implantation position is proper and the working condition is good, the operator can control the outer tube 2023 of the unlocking sleeve system 202 to enable the outer tube 2023 to move proximally relative to the inner tube 2013 connected with the fixing system 201, and the outer tube 2023 drives the unlocking sleeve 2021 to also move proximally through the unlocking sleeve connecting rod, namely the unlocking sleeve 2021 is far away from the connection part of the clamping structure and the valve bracket body 101; as a result of no longer being subjected to the force of the unlocking sleeve 2021, the distal end side of the first clip body no longer abuts against the distal end side of the second clip body, so that the clip structure is in a disconnected state, i.e. the distal end side of the first clip body is separated from the distal end side of the second clip body; . At this point (i.e., the second state), the valve stent body 101 (the strip) is no longer clamped, and then the connection release system and the post-implantation valve stent can be held in the annulus position 401 by gently rotating or rocking the connection release system to complete the unloading.

It should be appreciated that in this embodiment, the valve stent need not be provided with the tab structure 102.

Example 5

A medical implant connection release system, which is accommodated in a loading sheath 300 and comprises a connection fixing system 201 for connecting the medical implant and an unlocking sleeve system 202 for locking or releasing the connection fixing system 201 and the medical implant, wherein the connection fixing system 201 and the unlocking sleeve system 202 are arranged in the loading sheath 300 in a relatively sliding manner from inside to outside, wherein the connection fixing system 201 is provided with a connection fixing structure 2011 for capturing the medical implant, the unlocking sleeve system 202 is provided with an unlocking sleeve 2021, and when the connection fixing structure 2011 is engaged with the medical implant, the unlocking sleeve 2021 is locked at a joint point under the action of external force or is released by sliding away from the joint point;

Although the connecting and fixing structure 2011 is a hook structure in the present embodiment, it may be one or more of a lasso structure, a clip structure, or a hook structure.

In one possible embodiment, the connection and fixation system 201 includes an inner tube 2013 coaxially disposed with the loading sheath 300, the end of the inner tube 2013 has a first finger link 2012, and the connection and fixation structures 2011 are disposed on the finger links in a one-to-one correspondence;

in one possible embodiment, the unlocking sleeve system 202 includes an outer tube 2023 sleeved outside the inner tube 2013, the end of the outer tube 2023 has a second finger link 2022 that is not less than the first finger link 2012, and the unlocking sleeve 2021 passes through the first finger link 2012 in a one-to-one correspondence and is disposed on the second finger link 2022;

in one possible embodiment, the number of the connection fixing structures 2011 is 3-18, which is equal to the number of the unlocking sleeves 2021.

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 foregoing is merely illustrative of the present invention, and the present invention is not limited thereto, and any changes or substitutions easily contemplated by those skilled in the art within the scope of the present invention should be included in the scope of the present invention. Therefore, the protection scope of the present invention shall be subject to the protection scope of the claims.

Claims

1. The connection release structure is used for connecting a release object and is characterized by comprising a connection fixing system and an unlocking sleeve system, wherein the connection fixing system comprises a connection fixing structure which is movably connected with a loading sheath, the unlocking sleeve system comprises an unlocking sleeve which is movably connected with the loading sheath, when the connection release structure is used for being matched with the release object, the connection fixing structure is used for being connected with the release object, the unlocking sleeve is used for fixing or releasing the connection fixing structure and the release object, and when the connection fixing structure is in a first state, the connection fixing structure is used for being connected with the release object; in the second state, the connecting and fixing structure is used for being disconnected with the release object;

in the first state, the unlocking sleeve is sleeved on the connection part of the connection fixing structure and the release object so as to lock the connection fixing structure and the release object;

In the second state, the unlocking sleeve is not positioned at the joint of the connecting and fixing structure and the release object, and the connecting and fixing structure and the release object are not locked;

in the storage state, the connection release structure is used for partially or completely storing the release object in the loading sheath;

the loading sheath tube is retracted, the valve stent and the connection release system are completely released and opened, and the valve stent and the connection release system are in an expanded state;

wherein, unlocking sleeve pipe matches or clearance fit with release and couple structure.

2. The connection release structure according to claim 1, wherein a side of the connection fixing structure close to the loading sheath is a proximal side, and a side remote from the loading sheath is a distal side.

3. The connection release structure of claim 1, wherein the connection fixation structure is used to release or capture a release.

4. A connection release arrangement according to claim 1, wherein in the stowed condition the connection release arrangement is partially or wholly stowed within the loading sheath.

5. The connection release arrangement of claim 1, wherein in the stowed condition, the connection securing system and the unlocking sleeve system are partially or fully stowed within the loading sheath.

6. The connection release mechanism of claim 5, wherein in the stowed condition, the connection securing mechanism and the unlocking sleeve are partially or fully stowed within the loading sheath.

7. The connection release arrangement of claim 1, wherein in the second state, the unlocking sleeve is clear of the connection fixation arrangement and the release.

8. The connection release arrangement of claim 1, wherein the unlocking sleeve system comprises an outer tube disposed on the loading sheath, the outer tube being movably connected to the loading sheath, the outer tube having a second finger link at a distal end thereof, the unlocking sleeve being disposed on the second finger link.

9. The connection release arrangement of claim 8, wherein the outer tube is snap-fit, magnetically connected, rotationally connected and/or slidably connected to the loading sheath.

10. The connection release mechanism of claim 8, wherein the connection fixation system comprises an inner tube disposed on the loading sheath, the inner tube being movably coupled to the loading sheath, the end of the inner tube having a first finger link, the connection fixation mechanism being disposed on the first finger link in a one-to-one correspondence.

11. The connection release arrangement of claim 10, wherein the inner tube is snap-fit, magnetically connected, rotationally connected and/or slidably connected to the loading sheath.

12. The connection release arrangement of claim 10, wherein the unlocking sleeves pass through the first finger links in a one-to-one correspondence.

13. The connection release structure of claim 10, wherein the inner tube is slidably connected to the outer tube.

14. The connection release structure according to claim 13, wherein a sliding direction of the outer tube is the same as a sliding direction of the inner tube.

15. The connection release arrangement of claim 14, wherein the loading sheath is provided with a first through hole, the first through hole being mated with the outer tube.

16. The connection release structure according to claim 15, wherein a second through hole is provided in the outer tube, the second through hole is matched with the inner tube, and the first through hole extends in the same direction as the first through hole.

17. The connection release structure of claim 16, wherein the first and second through holes are coaxially disposed.

18. The connection release structure according to claim 1, wherein the number of the connection fixing structures is 3 to 18, which are arranged in equal amounts to the unlocking sleeve.

19. The connection release structure of claim 18, wherein the number of the connection fixing structure and the unlocking sleeve is 3-6.

20. The connection release structure according to claim 19, wherein the number of the connection fixing structure and the unlocking sleeve is 3.

21. The connection release structure according to claim 18, wherein the number of the connection fixing structure and the unlocking sleeve is 9 to 15.

22. The connection release structure according to claim 21, wherein the number of the connection fixing structure and the unlocking sleeve is 12.

23. The connection release system is characterized by comprising a connection fixing system, an unlocking sleeve system and a release object, wherein the connection fixing system comprises a connection fixing structure, the connection fixing structure is movably connected with a loading sheath, the unlocking sleeve system comprises an unlocking sleeve, the unlocking sleeve is movably connected with the loading sheath, the connection fixing structure is connected with the release object, the unlocking sleeve is locked to connect the connection fixing structure with the release object, and in a first state, the connection fixing structure is connected with the release object; in the second state, the connecting and fixing structure is used for being disconnected with the release object;

24. A connection release system according to claim 23, wherein in the stowed condition, the connection release structure is partially or wholly stowed within the loading sheath.

25. The connection release system of claim 24, wherein in the stowed condition, the connection securing system and the unlocking sleeve system are partially or fully stowed within the loading sheath.

26. A connection release system according to claim 23, wherein the connection fixation arrangement is used to release or capture a release.

27. The connection release system of claim 23, wherein the unlocking sleeve is rectangular, circular or oval in cross-section.

28. The connection release system of claim 24, wherein in the stowed state, the connection securing structure and the unlocking sleeve are partially or fully stowed in the loading sheath.

29. The connection release system of claim 23, wherein the release is a self-expanding valve stent comprising a valve stent body.

30. The connection release system of claim 29, wherein the self-expanding valve stent further comprises a tab structure mated with the connection release system, the tab structure being provided at least one end of the valve stent body.

31. The connection release system of claim 29, wherein a side of the connection fixation structure proximal to the loading sheath is a proximal side and a side distal to the loading sheath is a distal side.

32. The connection release system of claim 29, wherein the valve stent body is a mesh-like structure, the valve stent body having a length less than a diameter thereof.

33. The connection release system of claim 32, wherein the valve stent body is 18mm-30mm in length and 18mm-35mm in diameter.

34. The connection release system according to claim 30, wherein part or all of the connection fixing structures are hook structures, the hanger structures and the hook structures are arranged in a snap fastener, the hook structures are omega-shaped, L-shaped, E-shaped, C-shaped or zigzag-shaped, and the shapes of the hanger structures are T-shaped, L-shaped, E-shaped, C-shaped or zigzag-shaped in sequence.

35. The connection release system of claim 23, wherein in the second state, the unlocking sleeve is clear of a connection of the hook structure and the release.

36. The connection release system of claim 23, wherein the length of the unlocking sleeve is greater than or equal to the length of the connection of the hook structure to the release.

37. The connection release system of claim 23, wherein in the first state, the unlocking sleeve is positioned over the connection of the catch structure and the release, the unlocking sleeve matching or being in clearance fit with the release and the catch structure.

38. The connection release system of claim 30, wherein the tab structure is T-shaped, L-shaped, E-shaped, C-shaped, or zigzag-shaped.

39. A connection release system of a medical implant, which is accommodated in a loading sheath and is characterized by comprising a hook system for connecting the medical implant and an unlocking sleeve system for locking or releasing the hook system and the medical implant, wherein the hook system and the unlocking sleeve system are arranged in the loading sheath in a relatively sliding way from inside to outside, the hook system is provided with a hook structure for capturing the medical implant, the unlocking sleeve system is provided with an unlocking sleeve, when the hook structure is engaged with the medical implant, the unlocking sleeve is slid to a joint point to be locked under the action of external force or is slid away from the joint point to be released, and in the accommodating state, the connection release structure is used for accommodating the release in the loading sheath partially or completely; the loading sheath tube is retracted, the valve stent and the connection release system are completely released and opened, and the valve stent and the connection release system are in an expanded state;

40. The connection release system of claim 39, wherein the hooking system comprises an inner tube coaxially disposed with the loading sheath, the end of the inner tube having a first finger link, the hooking structures being disposed on the finger links in a one-to-one correspondence.

41. The connection release system of claim 40, wherein the unlocking sleeve system comprises an outer tube that is sleeved outside the inner tube, wherein the end of the outer tube has a second finger link that is not less than the first finger link, and wherein the unlocking sleeve passes through the first finger link and is disposed on the second finger link in a one-to-one correspondence.

42. The connection release system of claim 41, wherein the hook structures are provided in equal amounts to the unlocking sleeve, each of 3-18.