Guide wires with commissural anchors to advance a prosthetic valve

• US 9,132,009 B2
• Filed: 07/21/2010
• Issued: 09/15/2015
• Est. Priority Date: 07/21/2010
• Status: Active Grant

• Current Assignee: Cardiovalve Ltd.
• Original Assignee: Mitraltech Ltd.
• Inventors: Hacohen, Gil, Gross, Yossi, Papa, Marco
• Primary Examiner(s): Dornbusch, Dianne
• Assistant Examiner(s): LYNCH, ROBERT A
• Application Number:
  US12/840,463
• Publication Number:
  US 20120022639A1
• Time in Patent Office: 1,882 Days
• Field of Search: 623/2.1, 623/2.11, 623/2.12, 623 217- 219, 623/2.38, 623/2.4, 623/2.41
• US Class Current: 1/1
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/0647 having one single leg, e.g. tacks
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2/2487 Devices within the heart chamber, e.g. splints
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0063 Nested prosthetic parts

Abstract

Apparatus is provided, including one or more valve support guide members configured to be delivered to one or more commissures of a native atrioventricular valve of a patient, one or more valve support anchors configured to be anchored to the one or more commissures of the native valve, a prosthetic valve support advanceable toward the native valve along the one or more valve support guide members and anchored to the native valve at least the one or more commissures, and a prosthetic valve configured to be coupled to the valve support. Other applications are also described.

Claims

1. Apparatus, for use with a native atrioventricular valve of a patient, the native atrioventricular valve including leaflet tissue of at least two leaflets, the leaflets being connected to each other at one or more commissures, the apparatus comprising:

one or more sheaths, configured to be transluminally advanced to the native valve of the patient;

one or more valve support guide members, configured to be transluminally delivered via the one or more sheaths to the native atrioventricular valve;

one or more valve support anchors having at least two tissue-engaging surfaces, the valve support anchors being configured to be transluminally advanced, in a closed state thereof, to the native valve through at least one of the sheaths, to be opened to an open state thereof, at the native valve, by the tissue-engaging surfaces moving away from each other, and to subsequently be anchored to the leaflet tissue of the native valve;

a prosthetic valve support, disposable within one of the sheaths, and advanceable toward the native valve along the one or more valve support guide members, and configured to be placed at the native valve subsequently to the anchoring of the valve support anchors, and anchored to the leaflet tissue of the native valve by the valve support anchors; and

a prosthetic valve configured to be advanced to the prosthetic valve support independently of the valve support guide members, and to be coupled to the valve support subsequently to the placing of the prosthetic valve support at the native valve.

2. The apparatus according to claim 1, wherein the valve support is collapsible for transcatheter delivery and expandable to contact the native atrioventricular valve.

4. The apparatus according to claim 1, wherein the one or more valve support guide members comprises one valve support guide member that is looped through first and second commissures of the atrioventricular valve in a manner in which a looped portion of the valve support guide member is disposed in a ventricle of the patient and first and second free ends of the valve support guide member are accessible from a site outside a body of the patient.

5. The apparatus according to claim 1, wherein the one or more valve support anchors comprises first and second tissue anchors, the first and second tissue anchors being configured to be anchored to respective first and second commissures of the atrioventricular valve of the patient.

6. The apparatus according to claim 1, wherein:

the one or more valve support anchors each comprise one or more radially-expandable prongs, and

the one or more prongs are configured to be disposed within one of the sheaths in a compressed state prior to the anchoring, and exposed from within the sheath in order to expand and facilitate anchoring of the valve support anchor to the respective commissures.

7. The apparatus according to claim 1, wherein the prosthetic valve comprises two or more prosthetic leaflets.

8. The apparatus according to claim 1, wherein the native atrioventricular valve includes a mitral valve, and wherein the prosthetic valve comprises three prosthetic leaflets.

9. The apparatus according to claim 1, wherein the valve support guide members are removable from the patient following the anchoring of the prosthetic valve support at the atrioventricular valve.

10. The apparatus according to claim 1, wherein the valve support is shaped so as to define a distal portion which is configured to push aside, at least in part, native leaflets of the valve of the patient.

11. The apparatus according to claim 1, wherein the one or more valve support anchors are advanceable along the one or more valve support guide members.

12. The apparatus according to claim 1, wherein the valve support is shaped so as to define one or more holes, the one or more holes being configured to facilitate slidable passage therethrough of a respective one of the one or more valve support guide members.

13. The apparatus according to claim 1, wherein the prosthetic valve is shaped so as to define one or more snares configured to ensnare one or more of the native leaflets of the native valve of the patient.

14. The apparatus according to claim 1, wherein the one or more valve support anchors comprises one or more ventricular anchors, and wherein the apparatus further comprises one or more atrial anchors, each atrial anchor being configured to be advanced toward an atrial surface of the valve support and anchor in place the valve support in a vicinity of a respective one of the ventricular anchors.

15. The apparatus according to claim 1, further comprising one or more delivery tubes, slidable over a respective one of the valve support guide members, wherein:

each one of the one or more valve support anchors is removably coupled to a distal end of a respective one of the delivery tubes,

each delivery tube is configured to push the respective anchor through the at least one of the sheaths, and along the respective guide member, and

each delivery tube is decouplable from the respective anchor following the anchoring of the anchor to the leaflet tissue.

16. The apparatus according to claim 15, wherein the one or more valve support guide members are removable from the body of the patient following the pushing of the one or more anchors through the at least one of the sheaths.

17. The apparatus according to claim 15, wherein:

the valve support is shaped so as to define one or more holes,

the one or more holes are configured to facilitate slidable passage therethrough of a respective one of the one or more delivery tubes, and

the one or more delivery tubes are decoupleable from the respective valve support anchor following the anchoring of the valve support to the leaflet tissue.

18. The apparatus according to claim 17, wherein the one or more delivery tubes are removable from the body of the patient following the anchoring of the valve support to the leaflet tissue.

19. The apparatus according to claim 1, wherein the valve support comprises an annular element and a generally cylindrical element coupled to the annular element, the generally cylindrical element being configured to push aside the native leaflets of the native valve, and wherein the cylindrical element has first and second ends and a cylindrical body that is disposed between the first and second ends.

20. The apparatus according to claim 19, further comprising one or more annular element tissue anchors, wherein the annular element has an upper surface and a lower surface, and wherein the lower surface is coupled to the one or more annular element tissue anchors, the one or more annular element tissue anchors being configured to puncture tissue of a native annulus of the native valve of the patient.

21. The apparatus according to claim 20, wherein the one or more annular element tissue anchors comprises a plurality of annular element tissue anchors positioned around the lower surface of the annular element.

22. The apparatus according to claim 20, wherein the one or more annular element tissue anchors comprises a first commissural anchor configured to puncture tissue of the native valve at a first commissure thereof, and a second commissural anchor configured to puncture tissue of the native valve at a second commissure thereof.

23. The apparatus according to claim 20, wherein each anchor of the one or more annular element tissue anchors comprises a distal pointed tip and one or more radially-expandable prongs, the prongs being configured to expand and facilitate anchoring of the anchor and restrict proximal motion of the annular element tissue anchor.

24. The apparatus according to claim 19, further comprising one or more prosthetic valve guide members reversibly couplable to the cylindrical element in a vicinity of the second end of the cylindrical element, the prosthetic valve guide members being configured to facilitate advancement of the prosthetic valve therealong and toward the valve support.

25. The apparatus according to claim 24, wherein:

the first end of the cylindrical element is coupled to the annular element,

during a first period, the second end of the cylindrical element is disposed above the annular element in a manner in which the body of the cylindrical element is disposed above the annular element, and

the cylindrical element is invertible in a manner in which, during a second period, the second end of the cylindrical element is disposed below the annular element and the body of the cylindrical element is disposed below the annular element.

26. The apparatus according to claim 25, wherein:

the native valve has an annulus, and is disposed between an atrium of a heart of the patient, and a ventricle of the heart of the patient,

the valve support is configured such that, when the valve support is disposed at the native valve, during the first period, the second end of the cylindrical element is disposed in the atrium of the heart of the patient and the annular element is positioned along the annulus of the native valve,

the prosthetic valve is advanceable along the one or more prosthetic valve guide members into the ventricle of the heart of the patient, and

the apparatus is configured such that, in automatic response to the advancement of the prosthetic valve into the ventricle, the one or more prosthetic valve guide members are pulled into the ventricle and pull the second end and the body of the cylindrical element into the ventricle to invert the cylindrical element.

27. The apparatus according to claim 1, further including a guidewire, configured to be transluminally advanced to the native valve subsequently to the anchoring of the prosthetic valve support to the leaflet tissue, and configured to facilitate advancing of the prosthetic valve toward the prosthetic valve support.

28. The apparatus according to claim 1, wherein the valve support guide members are decouplable from the prosthetic valve support following the anchoring of the prosthetic valve support at the atrioventricular valve, and wherein the prosthetic valve is configured to be transluminally advanced to the native valve subsequently to decoupling of the valve support guide members from the prosthetic valve support.

29. The apparatus according to claim 1, wherein the one or more valve support anchors are generally blunt.

30. The apparatus according to claim 1, wherein the prosthetic valve is configured to be coupled to the prosthetic valve support by being expanded while a portion of the prosthetic valve is disposed within the prosthetic valve support, such that the prosthetic valve is held in place with respect to the prosthetic valve support responsively to radial forces acted upon the prosthetic valve support by the prosthetic valve.

3. The apparatus according to cairn 1, wherein the one or more valve support anchors are configured to be anchored to the leaflet tissue from ventricular surfaces thereof.