EP-4734877-A1 - CARDIAC ANCHORING STENT, VALVE SYSTEM AND A METHOD FOR DEPLOYING SAME

Abstract

A prosthetic cardiac valve system is disclosed comprising a stent comprising a flexible tubular element having an upstream mesh section, a downstream mesh section, and a radially deformable intermediate section extending therebetween. The upstream mesh section is configured with a plurality of upstream tissue engaging spikes, and/or the downstream mesh section is configured with a plurality of downstream tissue engaging spikes. The upstream tissue engaging spikes and the downstream tissue engaging spikes are made of memory shape material and are configured, at a closed position to be coplanar with an outside surface of the stent, and at an expanded deployed position of the stent, after being introduced in situ and reaching a predefined temperature to deform to their memory shape to project radially outwards from an outside surface of the stent to their radially outwards deformed position, controlled by the inflation of the downstream inflatable tubular element. An upstream elastic sleeve may extend over at least a portion of the upstream mesh section. The upstream elastic sleeve can have an upstream inflatable tubular element disposed axially upstream of the upstream mesh section or downstream of the upstream mech section. A prosthetic cardiac valve can be configured to be secured within the upstream elastic sleeve after the stent is positioned in situ and the upstream inflatable tubular element of the upstream elastic sleeve is inflated. The prosthetic valve leaflets can be integrated as one piece within the prosthetic cardiac valve system.

Inventors

• BURG, Shira
• ELISHA, Elad
• TUBISHEVITZ, AMIT

Assignees

• SYMBIOSIS C.M. LTD

Dates

Publication Date

20260506

Application Date

20240628

Claims (20)

1. 1. A prosthetic cardiac valve system, comprising: a stent comprising a flexible tubular element having an upstream mesh section, a downstream mesh section, and a radially deformable intermediate section extending therebetween, wherein the upstream mesh section is configured with a plurality of upstream tissue engaging spikes, and/or the downstream mesh section is configured with a plurality of downstream tissue engaging spikes; wherein said upstream tissue engaging spikes and said downstream tissue engaging spikes are made of memory shape material and are configured, at a closed position to be coplanar with an outside surface of the stent, and at an expanded deployed position of the stent, after being introduced in situ and reaching a predefined temperature to deform to their memory shape to project radially outwards from an outside surface of the stent to their radially outwards deformed position; an upstream elastic sleeve extending over at least a portion of said upstream mesh section, said upstream elastic sleeve having an upstream inflatable tubular element disposed axially upstream of said upstream mesh section; and a prosthetic cardiac valve secured within one or more of the mesh sections of said stent, after said stent is positioned in situ and the upstream and downstream inflatable tubular elements of said upstream and downstream elastic sleeves are inflated.
2. 2. The prosthetic cardiac valve system of claim 1, wherein the prosthetic cardiac valve is integrated with the stent.
3. 3. The prosthetic cardiac valve system of claim 1, comprising valve leaflets attached to the upstream elastic sleeve and/or one or more of the mesh sections.
4. 4. The prosthetic cardiac valve system of any one of the preceding claims, wherein the stent is configured for positioning and securing within a cardiac valve cavity, wherein at its deployed, expanded position the upstream inflatable tubular element is configured for bearing over the annulus of a native cardiac valve, to thereby seal and prevent blood flow external to the sleeve.
5. 5. The prosthetic cardiac valve system of any one of the preceding claims, wherein the stent is configurable for positioning and securing within a cardiac valve cavity, and wherein when the stent assumes its expanded shape and bears against the native annulus, the inflated upstream inflatable tubular element bears over the annulus of a native cardiac valve, and functions as a seal to prevent blood flow external to the sleeve.
6. 6. The prosthetic cardiac valve system of claim 5, wherein at the deployed position, when the upstream inflatable tubular element is inflated, it serves as an annular seal disposed radially, surrounding the prosthetic cardiac valve, to restrict blood flow only through said prosthetic cardiac valve.
7. 7. The prosthetic cardiac valve system according to any one of the preceding claims, wherein the upstream mesh section and a downstream mesh section define between them a flow path in direction from the upstream mesh section to the downstream mesh section, in correspondence with normal hemodynamics.
8. 8. The prosthetic cardiac valve system according to any one of the preceding claims, wherein a prosthetic cardiac valve is secured within the upstream mesh section of the stent, said cardiac valve being configured and operable for blood flow administration along the flow path, in direction from the upstream mesh section to the downstream mesh section in direction corresponding with normal hemodynamics.
9. 9. The prosthetic cardiac valve system according to any one of the preceding claims, wherein the stent further comprises a downstream elastic sleeve extending over at least a portion of an inside face of the intermediate mesh section, said downstream elastic sleeve having a downstream inflatable tubular element axially and radially disposed in overlap over at least an inside portion of the intermediate mesh section and the portion of the downstream mesh section.
10. 10. The prosthetic cardiac valve system of claim 9, wherein the upstream elastic sleeve and the downstream elastic sleeve are a homogeneous sleeve or independent sleeves.
11. 11. The prosthetic cardiac valve system of claim 9 or 10, wherein each of the upstream elastic sleeve and the downstream elastic sleeve are secured to either an inside face of stent, or to an outside face thereof.
12. 12. The prosthetic cardiac valve system of any one of claims 9 to 11, wherein the sleeve member is a continuous sleeve member comprising an intermediate portion extending between the upstream elastic sleeve and the downstream elastic sleeve.
13. 13. The prosthetic cardiac valve system according to any one of the preceding claims, wherein the inflatable tubular element is configured with an inflating mechanism for inflating and pressure regulating of the volume and pressure within the inflatable tubular element.
14. 14. The prosthetic cardiac valve system according to any one of the preceding claims, wherein the inflatable tubular element is associated with an inflation/deflation port.
15. 15. The prosthetic cardiac valve system according to any one of the preceding claims, wherein the inflatable tubular element is disposed within an annular pouch of the sleeve.
16. 16. The prosthetic cardiac valve system according to any one of the preceding claims, wherein the inflatable tubular element is inflatable with a fluid comprising a puncture sealing agent.
17. 17. The prosthetic cardiac valve system according to any one of claims 9 to 16, wherein the upstream inflatable tubular element and the downstream inflatable tubular element are received within an enveloping portion of the upstream elastic sleeve and a downstream elastic sleeve, respectively.
18. 18. The prosthetic cardiac valve system according to any one of claims 9 to 17, wherein the upstream inflatable tubular element and the downstream inflatable tubular element are configured as an annular pocket of the sleeve, accommodating an inflatable supra and sub-annular balloon.
19. 19. The prosthetic cardiac valve system according to any one of the preceding claims, wherein the upstream tissue engaging spikes face towards a downstream side of the stent and the downstream tissue engaging spikes face towards an upstream side of the stent.
20. 20. The prosthetic cardiac valve system according to any one of the preceding claims, wherein the intermediate mesh section is configured and operable as an undulating section, axially extending between the upstream mesh section and the downstream mesh section.

Description

CARDIAC ANCHORING STENT, VALVE SYSTEM AND A METHOD FOR DEPLOYING SAME TECHNOLOGICAL FIELD The present disclosure is concerned with a cardiac valve, a personalized anchoring and sealing mechanism therefor, and a method for deploying and anchoring same. BACKGROUND ART Cardiac valve replacement may be necessary in cases where the valve is severely damaged or diseased. Replacement of a cardiac valve can often involve complications related with anatomic differences such as variable outlines and borders at the valve site. References considered to be relevant as background to the presently disclosed subject matter: WO22201158; WO2017151566; US8,556,881; US2022241071; WO2022201158; US2009088836; WO2017151566. Acknowledgement of the above references herein is not to be inferred as meaning that these are in any way relevant to the patentability of the presently disclosed subject matter. BACKGROUND WO22201158 discloses a supporting structure for accommodating a prosthetic valve aimed at replacing valve, a prosthetic valve system, a method for sealing between a native tissue and a prosthetic implant, a kit for implanting a prosthetic valve and a medium to be used with a supporting structure. The technique provides an implant structure with high compatibility with various anatomies while allowing optimal sealing and tissue anchoring, thus implementing personalized valve replacement procedures. This technique provides an accurate fitting for optimal sealing and anchoring to various complex anatomies necessitating a prosthesis. WO2017151566 discloses methods, devices, and systems for anchoring and/or sealing a heart valve prosthesis and, in particular, a mitral valve prosthesis, wherein inflatable elements are used to seal and anchor the mitral valve prosthesis and/or other elements associated with repairing a native mitral valve. US2022104940 discloses prosthesis configured to grasp intraluminal tissue when deployed within a body cavity and prevent axial flow of fluid around an exterior of the prosthesis. The prosthesis can include an expandable frame configured to radially expand and contract for deployment within the body cavity and a valve body. The expandable frame can include a frame body and a supplemental frame. The valve body can include a plurality of leaflets and one or more intermediate components. The one or more intermediate components can couple at least a portion of the leaflets to the expandable frame. The prosthesis can include an annular flap positioned around an exterior of the expandable frame. Acknowledgement of the above references herein is not to be inferred as meaning that these are in any way relevant to the patentability of the presently disclosed subject matter. GENERAL DESCRIPTION A first aspect of the disclosure is directed to a support structure for supporting a prosthetic cardiac valve, said support structure comprising a flexible tubular stent having an upstream mesh section and a downstream mesh section, with a radially deformable intermediate mesh section extending therebetween, and wherein the upstream mesh section is configured with a plurality of upstream tissue engaging spikes and/or the downstream mesh section is configured with a plurality of downstream tissue engaging spikes; wherein at an expanded position of the stent said upstream tissue engaging spikes and said downstream tissue engaging spikes project radially outwards from an outside surface of the stent; and an upstream elastic sleeve extending over at least a portion of said upstream mesh section; said upstream elastic sleeve having an upstream inflatable tubular element disposed axially upstream of said upstream mesh section. The terms ‘ upstream ’ and ‘ downstream ’ as used herein in the specification and claims, correspond with normal hemodynamics flow directions, respectively. Accordingly, when considering a mitral valve blood flows in direction from the upstream left atrium towards the downstream left ventricle; when considering a tricuspid valve blood flows in direction from the upstream right atrium towards a downstream right ventricle; when discussing the aortic valve blood flows in direction from the upstream left ventricle towards the downstream aorta, and; and when discussing the pulmonary valve blood flows in direction from the upstream right ventricle towards the downstream pulmonary artery. The term ‘valve ’ as used herein the specification and claims denotes a prosthetic valve engageable within the elastic sleeve, and configurable as a one-way valve, facilitating blood flow in correspondence with hemodynamics flow directions. The prosthetic valve is inherent with a carrier stent, wherein a nominal diameter of the stent of the prosthetic valve, at its deployed position, is greater than a nominal diameter of the stent at its deployed position, hence once deployed, the prosthetic valve is engageable within the elastic sleeve. However, according to another example, the prosthetic valve can be directly secur