CN117414234A

CN117414234A - Valve frame, valve counterpoint fixed knot construct and valve recovery unit

Info

Publication number: CN117414234A
Application number: CN202311390079.9A
Authority: CN
Inventors: 陈秀敏; 蒋骏杰
Original assignee: Shanghai Aoliu Medical Technology Co ltd
Current assignee: Shanghai Aoliu Medical Technology Co ltd
Priority date: 2023-10-25
Filing date: 2023-10-25
Publication date: 2024-01-19

Abstract

An alignment fixture 100 for a replacement valve replacement structure, comprising: a ring-shaped structure 101; a centrally located guide tip 102, the guide tip 102 extending from the bottom tapering away from the annular structure 101, a recess 103 being provided in the bottom of the guide tip 102; a plurality of inner support struts 104, said inner support struts 104 extending radially outwardly from said bottom of said guide tip 102 to said annular structure 101 and being connected to said annular structure 101.

Description

Valve frame, valve counterpoint fixed knot construct and valve recovery unit

Technical Field

The present invention relates to a valve holder for replacing a valve replacement structure, a valve alignment fixing structure, and a valve recovery device.

Prior Art

Heart valves (e.g., aortic, pulmonary, tricuspid, mitral, etc.) play an important role in the cardiovascular system. These valves may be partially or fully functional lost due to congenital, inflammatory, aging, infection, etc., ultimately causing serious cardiovascular damage or death. Traditionally, open heart surgery has been used to create a significant burden on the patient.

Currently, newer transcatheter heart valve prostheses and heart valve replacement procedures have come into the general field of view, which are less invasive and more conducive to patient recovery. In this technique, a prosthetic valve is delivered to an implantation site in a compressed state and then expanded to its functional size at the site of the defective native valve, thereby repairing or replacing diseased tissue. Among them, the scheme employing valve replacement is relatively broader in indication and is therefore of greater concern.

Until the present market, the industry has adopted integrated implantation instruments for performing heart valve replacement. The scheme is that the implanted valve of the scheme inevitably generates aging and pathological changes again in the future due to the self physical condition of the patient matched with the gradually prolonged life expectancy of modern people. At this time, due to the occupation of the implantation apparatus, the replacement of the valve will have to be performed by an open heart operation, which inevitably increases the pain of the patient.

Therefore, how to improve the heart valve replacement device to prolong the service life and avoid the difficulty of replacement when the valve is damaged becomes one of the difficulties in the industry.

Disclosure of Invention

In view of this, the present invention provides an alignment fixing structure of a replacement valve replacement structure, including: a ring-shaped structure; a centrally located guide tip extending from a bottom portion, tapering away from the annular structure, the bottom portion of the guide tip being provided with a recess; and a plurality of inner support frames extending radially outwardly from the bottom of the guide tip to and connected with the annular structure.

According to one aspect of the foregoing aspect, an expandable and contractible expansion block is provided in the recess.

According to one aspect of the foregoing, a groove is provided in the annular structure.

According to one aspect of the foregoing technical solution, the alignment fixing structure is connected with an outer frame fixedly connected to the affected part.

Since the alignment fixing structure is provided with the guide tip, it is easier to fix the valve frame in alignment. A recess is provided in the bottom of the guide tip, in which a fixation hook can be received to fix the valve holder. In addition, grooves are arranged in the annular structure and can be matched with corresponding stabilizing structures on the valve frame so as to further increase the fixing strength between the alignment fixing structure and the valve frame. Finally, an expandable and contractible expansion block is provided in the recess, whereby the fixation hooks received therein can be pushed outwardly by the driven expansion of the expansion block to facilitate the removal of the valve frame from the alignment fixation structure.

The invention also provides a valve holder of a replacement valve replacement structure, comprising: the top of the central block protrudes outwards, and the bottom of the central block is provided with a sharp slot; a plurality of upper arms, one ends of which extend at an angle from the bottom of the center block; and a plurality of lower arms extending from the other ends of the upper arms at another angle, wherein a fixing hook extending towards the center is arranged at one end of the lower arms away from the upper arms.

According to one aspect of the foregoing aspect, the connection between the upper arm and the lower arm, and the connection between the upper arm and the central block are made of memory metal.

According to one aspect of the foregoing, a valve is disposed on the upper arm and/or the lower arm.

According to one aspect of the foregoing solution, a stabilizing structure is provided at the junction of the upper and lower arms.

According to one aspect of the foregoing solution, the stabilizing structure is provided with a sizing wire.

According to one aspect of the foregoing, a valve is disposed on the sizing wire.

Because of the provision of the top protrusion, the bottom portion provides a central block of spike slots that can be engaged by the retrieval device to separate the valve frame, the spike slots can cooperate with the guide spikes of the alignment fixture to facilitate alignment of the alignment fixture with the valve frame. The fixing hook can extend into the concave part at the bottom of the guide tip to fix the valve frame and the alignment fixing structure together. In addition, due to the provision of the stabilizing structure, it cooperates with the slots in the annular structure of the alignment fixture structure to further increase the fixation strength between the alignment fixture structure and the valve holder. The setting wire can fix the valve better. In addition, as the connection part of the upper arm and the lower arm and the connection part of the upper arm and the central block are made of memory metal, the included angle between the upper arm and the lower arm can be changed when the temperature changes, so that the valve frame is separated from the alignment fixing structure.

The invention also provides a recovery device of the replacement valve replacement structure, which comprises: a feeding device; a connecting block, one end of which is connected to the feeding device; the other end of the connecting block is provided with a plurality of recovery hooks which are opposite to each other and extend inwards, and the connecting block is provided with a heat regulating mechanism for controlling the temperature of the connecting block.

According to one aspect of the foregoing aspect, the connection block further comprises an outwardly extending ablation device positioned to correspond to the stabilization structure of the valve holder for ablating endothelial tissue on the stabilization structure.

The heat adjusting mechanism is arranged on the connecting block, so that the temperature of the connecting block can be controlled, the connecting angle of the upper arm and the lower arm which are connected with the connecting block and comprise the memory metal part can be adjusted, and meanwhile, the heat adjusting mechanism can transfer heat to the expansion block in the concave part of the alignment fixing structure to expand the expansion block so as to eject the fixing hooks in the concave part, so that the valve can be recovered. In addition, due to the arrangement of the ablation device, the endothelial tissue around the stable structure can be ablated so as to be separated.

Drawings

FIGS. 1A and 1B show side and top views, respectively, of an alignment fixture of a replacement valve replacement structure according to the present invention;

FIGS. 2A and 2B show side and top views, respectively, of a valve holder of a replacement valve replacement structure according to the present invention;

FIG. 3 shows a top view of a replacement valve according to the present invention mounted on a valve holder;

FIGS. 4A-4C illustrate method steps for mounting a valve frame in an alignment fixture according to the present invention, respectively;

FIG. 5 is a schematic view of a recovery device according to the present invention;

FIG. 6 is a schematic view of another embodiment of a retrieval device according to the present invention, with an ablation device added, and depicting the retrieval device with the ablation device in positional relationship with a valve frame alignment fixture assembly;

fig. 7A-7F are method steps for removing a valve frame from an alignment fixture with a recovery device in accordance with the present invention.

It should be understood that the drawings are not necessarily to scale, some portions may be exaggerated to highlight structural details of the present invention.

Detailed Description

Various embodiments of the present invention are described below with reference to the accompanying drawings, which form a part hereof. It is to be understood that, although various terms indicating directions, such as "front", "rear", "upper", "lower", "left", "right", "top", "bottom", etc., may be used herein to describe various exemplary structural portions and components of the present invention, these terms are used herein for convenience of description and are determined based on the exemplary orientations shown in the drawings. Since embodiments of the present invention may be arranged in different orientations, these directional terminology is used for purposes of illustration and is in no way limiting.

Various embodiments of the present invention will now be described with reference to the accompanying drawings.

Fig. 1A and 1B show side and top views, respectively, of an alignment fixture of a replacement valve replacement structure according to the present invention. Referring to fig. 1A and 1B, the alignment fixture 100 of the replacement valve replacement structure includes: an annular structure 101, the annular structure 101 being defined by an outer ring and an inner ring, a groove 106 being defined in the annular structure 101, a guide tip 102 being provided in the centre of the annular structure 101, the guide tip 102 extending from the bottom tapering away from the annular structure 101, a recess 103 being provided in the bottom of the guide tip 102, an expandable and contractible expansion block 105 being provided in the recess 103, the expansion block 105 being expandable or otherwise changing volume or shape when heated. A number of internal support frames 104, three of which are shown extending radially outwardly from the bottom of the guide tip 102 to the annular structure 101 (and specifically to the inner ring) and connected to the annular structure 101, are shown in a preferred embodiment in which the three internal support frames are positioned from three directions for accurate positioning and to facilitate valve deployment, but it should be understood that the number of internal support frames can vary as desired. The alignment fixture 100 is connected to an outer frame (not shown) that is fixedly attached to the affected part.

Fig. 2A and 2B show side and top views, respectively, of a valve holder of a replacement valve replacement structure according to the present invention. As shown in fig. 2A and 2B, the valve holder 200 of the replacement valve replacement structure includes a central block 201 with a top portion protruding outward and a bottom portion provided with a pointed slot 202 for receiving the guide point 102 of the alignment fixture 100 described previously in connection with fig. 1A and 1B to align the valve holder 200 with the alignment fixture 100. The valve holder 200 of the replacement valve replacement structure further comprises a number of upper arms 203, one end of which extends at an angle from the bottom of the central block 201; and a plurality of lower arms 204 extending from the other ends of the upper arms 203 at another angle. As shown in fig. 2B, the upper arm 203 and the lower arm 204 each have three, but the number of the upper arm 203 and the lower arm 204 in the present invention may be changed according to circumstances. At the intersection of the upper arm 203 and the lower arm 204 is provided a stabilizing structure 206, which stabilizing structure 206 may be a protruding structure to mate with the groove 106 in the ring structure 101. In one embodiment, the stabilizing structure 206 is formed as a convex tip and the slot 106 in the annular structure 101 is designed as a pointed slot, but the invention is not limited thereto. In another embodiment, as shown in FIG. 2B, a sizing wire 207 is provided on the stabilizing structures 206, forming a loop around each stabilizing structure 206. The junction of the upper arm 203 and the lower arm 204, and the junction of the upper arm 203 and the center block 201 are composed of a memory metal, which can change shape according to temperature, thereby changing the angle between the upper arm 203 and the lower arm 204. The valve holder 200 further comprises fixation hooks 205 extending towards the centre at the end of the lower arm 204 remote from the upper arm 203, these fixation hooks 205 being opposite each other.

As shown in fig. 3, the valve may be secured to the upper arm 203 and/or lower arm 204, or to a sizing wire 207 provided on the stabilizing structure 206.

Fig. 4A-4C show the method steps of mounting a valve frame according to the invention in an alignment fixture, respectively.

As shown in fig. 4A, the outer frame (not shown) is first transported and fixed to the position of the annulus by a catheter (not shown), and the outer frame is adjusted so that the alignment and fixation structure 100 thereon is properly positioned; the valve holder 200 is delivered to the top of the alignment fixture 100 such that the central gap of the opposing fixation hooks 205 of the valve holder 200 are aligned with the guide tips 102 in the middle of the alignment fixture 100.

Subsequently, as shown in fig. 4B, continued advancement of the valve holder 200 causes the fixation hooks 205 to move along the outer wall of the guide tip 102 and snap into the bottom of the guide tip 102, while causing the shape memory valve holder 200 body to deform sufficiently thermally, the operator can pull back slightly to confirm that the fixation hooks 205 are properly seated.

Subsequently, as shown in fig. 4C, the valve holder 200 is rotated so that its lower arm 204 abuts against the inner support frame 104 of the alignment fixture 100, thereby confirming the alignment accuracy; the valve holder 200 is then fully released, whereby the valve holder 200 is restored to its deformed folded state such that the stabilizing structure 206 at the intersection of the upper and lower arms 203, 204 is embedded in the groove 106 of the annular structure 101 of the alignment fixture 100, whereupon the fixture hooks 205 penetrate into the recesses 103 at the bottom of the guide tips 102, and the tip grooves 202 at the bottom of the central block 201 at the top of the valve holder 200 are fixed to the top of the guide tips 102, thereby allowing the alignment fixture 100 to be connected to the valve holder 200 at the bottom of the guide tips 102, the top of the guide tips 102, and the groove 106 of the annular structure 101, respectively.

With this method, the connection of the alignment fixture 100 to the valve frame 200 will be easier and the connection between the two will be stronger.

Fig. 5 is a schematic view of a recycling apparatus 300 according to the present invention. The recovery device 300 comprises a feeding device 301, and the feeding device 301 may be a rope or a push rod. The recovery device 300 further includes a connection block 302, one end of the connection block 302 is connected to the feeding device 301, and a plurality of recovery hooks 303 are provided at the other end of the connection block 302, and the recovery hooks 303 are opposed to each other and protrude inward. In the embodiment of fig. 5, two recovery hooks 303 are shown, but it should be understood that the number of recovery hooks 303 may vary depending on the particular situation. A heat regulating mechanism (not shown) may be provided on the connection block 302 to control the temperature of the connection block 302.

Fig. 6 shows another embodiment of a recycling apparatus 300. In this embodiment, the connection block 302 further includes an outwardly extending ablation device 304, which ablation device 304 may be an ablation block or an ablating loop. The position of the ablation device 304 corresponds to the stabilization structure 206 (e.g., the sizing wire 207) of the valve holder 200 for ablating endothelial tissue of the valve on the stabilization structure 206 for easy removal.

Fig. 7A-7B illustrate method steps for removing a valve frame from an alignment fixture with a recovery device according to the present invention.

As shown in fig. 7A, the recovery hooks 303 of the recovery device 300 are first conveyed to the top of the center block 201 and aligned.

Then, as shown in fig. 7B, the recovery hooks 303 are continuously pushed, and the recovery hooks 303 contact the top of the center block 201 and are spread outward along the outer wall of the center block 201.

Then, as shown in fig. 7C, the recovery hook 303 is advanced continuously, so that the recovery hook 303 moves into the tip groove 202 at the bottom of the center block 201 along the center block outer wall, and so that the top of the center block 201 is positioned against the corresponding position of the recovery hook 303.

Next, as shown in fig. 7D, the central block 201 is heated by the heat adjusting mechanism, and the expansion block 105 in the recess 103 at the bottom of the guide tip 102 is expanded by heat transfer to push out the fixing hook 205, and the upper and lower arms 203, 204 (original shape memory set failure) having the shape memory portions connected thereto are deformed and stretched.

Finally, as shown in fig. 7E and 7F, the recovery hook 303 and the valve frame 200 hooked by the recovery hook are lifted up, so that the valve frame 200 is smoothly separated from the alignment fixing structure 100.

When the valve fixation time is long and the endothelialization of the surface of the valve frame 200 is complete, the ablation device 304 shown in fig. 6 is used to ablate the valve tissue around the stabilizing structure 206 (such as the shaping wire 207) at the folding point of the upper and lower arms 203, 204 when the upper and lower arms 203, 204 with the shape memory parts are temperature-adjusted by the recovery hooks, so that the valve tissue is easily separated from the groove 106 on the annular structure 101 of the alignment and fixation structure 100.

While the invention has been disclosed in conjunction with the embodiments described above, various alternatives, modifications, variations, improvements, and/or substantial equivalents, whether known or that may be presently or later to be considered, will be apparent to those of ordinary skill in the art. In addition, technical effects and/or technical problems described in the present specification are exemplary and not limiting, so the disclosure of the present specification may be used to solve other technical problems and have other technical effects. Accordingly, the foregoing description of the embodiments of the invention is intended to be illustrative rather than limiting. Various changes may be made without departing from the spirit or scope of the invention. Accordingly, the present invention is intended to embrace all known or earlier developed alternatives, modifications, variations, improvements and/or substantial equivalents.

Claims

1. An alignment fixture (100) for a replacement valve replacement structure, comprising:

-an annular structure (101);

a centrally located guide tip (102), the guide tip (102) extending from the bottom away from the annular structure (101) in a tapering manner, a recess (103) being provided in the bottom of the guide tip (102);

-an inner support (104), said inner support (104) extending radially outwards from said bottom of said guiding tip (102) to said annular structure (101) and being connected to said annular structure (101).

2. The para-position fixing structure (100) of a replacement valve replacement structure according to claim 1, wherein an expansion block (105) which can expand and contract is provided in the recess (103).

3. The para-position fixation structure (100) of a replacement valve replacement structure of claim 1, wherein a groove (106) is provided in the ring structure (101).

4. The valve replacement structure alignment fixture (100) of claim 1, wherein said alignment fixture (100) is coupled to an outer frame that is fixedly coupled to the lesion.

5. A valve holder (200) for replacing a valve replacement structure, comprising:

the center block (201), the top of the center block (201) protrudes outwards, and the bottom of the center block is provided with a sharp slot (202);

an upper arm (203) having one end extending at an angle from the bottom of the central block (201);

a lower arm (204) extending from the other end of the upper arm (203) at another angle, wherein a fixing hook (205) extending toward the center is provided at an end of the lower arm (204) away from the upper arm (203).

6. The replacement valve replacement structure valve holder (200) of claim 5, wherein the junction of the upper arm (203) and the lower arm (204), the junction of the upper arm (203) and the central block (201) is comprised of a memory metal.

7. The replacement valve replacement structure valve holder (200) of claim 5, wherein a valve is provided on the upper arm (203) and/or the lower arm (204).

8. The replacement valve replacement structure valve holder (200) of claim 5, wherein a stabilizing structure (206) is provided at the intersection of the upper arm (203) and the lower arm (204).

9. The replacement valve replacement structure valve holder (200) of claim 8, wherein a sizing wire (207) is provided on the stabilizing structure (206).

10. The replacement valve replacement structure valve holder (200) of claim 9, wherein a valve is disposed on the sizing wire (207).

11. A retrieval device (300) for a replacement flap replacement structure, comprising:

a feeding device (301);

-a connection block (302), one end of the connection block (302) being connected to the feeding device (301);

the other end of the connecting block (302) is provided with a plurality of recovery hooks (303), the recovery hooks (303) are opposite to each other and extend inwards, and a heat adjusting mechanism is arranged on the connecting block (302) to control the temperature of the other end of the connecting block (302).

12. The retrieval device (300) of claim 11, wherein the connection block (302) further includes an outwardly extending ablation device (304), the ablation device (304) being positioned to correspond to the stabilization structure (206) of the valve frame (200) for ablating endothelial tissue on the stabilization structure (206).