TECHNIQUES FOR DEPLOYMENT OF A PROSTHETIC VALVE

• US 20170333187A1
• Filed: 08/03/2017
• Published: 11/23/2017
• Est. Priority Date: 02/05/2015
• Status: Active Grant

• Current Assignee: Cardiovalve Ltd.
• Original Assignee: Mitraltech Ltd.
• Inventors: Hariton, Ilia, Harari, Boaz, Karalnik, Maxim, Iamberger, Meni
• Granted Patent: US 10,918,481 B2
• Time in Patent Office: Days
• 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 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2002/91575 connected peak to trough
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements

Abstract

A delivery tool includes a delivery capsule, disposed at a distal portion of the tool. The delivery capsule includes a proximal capsule-portion dimensioned to house a first part of an implant, and a distal capsule-portion dimensioned to house a second part of the implant; and an extracorporeal control portion, disposed at a proximal portion of the tool, the control portion including one or more controllers and one or more locks. The controllers are operatively coupled to the proximal and distal capsule-portions such that the proximal and distal capsule-portions are movable with respect to the implant via actuation of the controllers. The tool has sequential states in which movement of the proximal and distal capsule-portions is variously inhibited or facilitated.

Claims

1. Apparatus comprising an implant and a delivery tool, the tool comprising:

a delivery capsule, disposed at a distal portion of the tool, the delivery capsule comprising a proximal capsule-portion dimensioned to house a first part of the implant, and a distal capsule-portion dimensioned to house a second part of the implant; and

an extracorporeal control portion, disposed at a proximal portion of the tool, the control portion comprising one or more controllers and one or more locks, the controllers being operatively coupled to the proximal and distal capsule-portions such that the proximal and distal capsule-portions are movable with respect to the implant via actuation of the controllers,

wherein the controllers and the locks are mechanically cooperative such that;

in a state A of the tool;

a first distal movement of the distal capsule-portion up to a first distance distally with respect to the implant is facilitated,

a second distal movement of the distal capsule-portion further distally with respect to the implant is inhibited, and

a proximal movement of the proximal capsule-portion proximally with respect to the implant is facilitated; and

in a state B of the tool;

the second distal movement of the distal capsule-portion is facilitated.

2. The apparatus according to claim 1, wherein in the state A, a lock of the one or more locks is locked, and unlocking of the lock transitions the tool into the state B.

3. The apparatus according to claim 2, wherein the lock is not unlockable until the distal capsule-portion has been moved the first distance distally with respect to the implant.

4. The apparatus according to claim 2, wherein the lock is not unlockable until the proximal capsule-portion has been moved proximally with respect to the implant.

5. The apparatus according to claim 1, wherein:

the one or more controllers comprise a first controller and a second controller, and

in the state A, actuation of the first controller causes the first distal movement of the distal capsule-portion, and actuation of the second controller causes the proximal movement of the proximal capsule-portion.

6. The apparatus according to claim 5, wherein, in the state B, further actuation of the first controller causes the second distal movement of the distal capsule-portion.

7. The apparatus according to claim 5, wherein the one or more controllers further comprise a third controller, and wherein, in the state B, actuation of the third controller causes the second distal movement of the distal capsule-portion.

8. The apparatus according to claim 1, wherein the implant is for use at a native mitral valve of a subject, and wherein:

the first part of the implant comprises an upstream support portion, configured to be placed against an upstream surface of the native mitral valve,

the second part of the implant comprises a downstream end of the implant, and a plurality of flanges (i) disposed longitudinally between the upstream support portion and the downstream end, and (ii) configured to engage leaflets of the native mitral valve; and

the implant is housed by the delivery capsule such that the first distal movement of the distal capsule-portion unhouses, from the distal capsule-portion, the plurality of flanges, but not the downstream end of the implant.

9. The apparatus according to claim 8, wherein the implant is housed by the delivery capsule such that the second distal movement of the distal capsule-portion unhouses, from the distal capsule-portion, the downstream end of the implant.

10. The apparatus according to claim 8, wherein the implant is housed by the delivery capsule such that the proximal movement of the proximal capsule-portion unhouses, from the proximal capsule-portion, the upstream support portion.

11. The apparatus according to claim 8, wherein the implant comprises:

a valve frame that comprises;

a tubular portion shaped to define a lumen therethrough, and

the upstream support portion, extending from an upstream end of the tubular portion;

an outer frame that circumscribes the tubular portion, and comprises the plurality of flanges; and

a plurality of prosthetic leaflets, coupled to the tubular portion within the lumen.

12. The apparatus according to claim 11, wherein the second part of the implant comprises at least part of the tubular portion.

13. Apparatus comprising an implant and a delivery tool, the tool comprising:

a delivery capsule, disposed at a distal portion of the tool, the delivery capsule comprising a proximal capsule-portion dimensioned to house a first part of the implant, and a distal capsule-portion dimensioned to house a second part of the implant; and

an extracorporeal control portion, disposed at a proximal portion of the tool, the control portion comprising one or more controllers and one or more locks, the controllers being operatively coupled to the proximal and distal capsule-portions such that the proximal and distal capsule-portions are movable with respect to the implant via actuation of the controllers,

wherein the controllers and the locks are mechanically cooperative such that;

in a first state of the tool;

a first distal movement of the distal capsule-portion up to a first distance distally with respect to the implant is facilitated,

a second distal movement of the distal capsule-portion further distally with respect to the implant is inhibited,

a proximal movement of the proximal capsule-portion proximally with respect to the implant is inhibited, and

responsively to movement of the distal capsule-portion distally, the tool automatically unlocks a second state of the tool;

in the second state of the tool;

the proximal movement of the proximal capsule-portion is facilitated,

the second distal movement of the distal capsule-portion remains inhibited, and

responsively to movement of the proximal capsule-portion proximally, the tool automatically unlocks a third state of the tool; and

in the third state of the tool;

the second distal movement of the distal capsule-portion is facilitated.

14. The apparatus according to claim 13, wherein the tool automatically unlocks the second state responsively to the distal capsule-portion having moved the first distance.

15. The apparatus according to claim 13, wherein:

the one or more locks comprise a first lock and a second lock,

the one or more controllers comprise a first controller and a second controller,

in the first state of the tool, actuation of the first controller causes the first distal movement of the distal capsule-portion,

the tool automatically unlocks the second state by automatically making the first lock unlockable,

in the second state of the tool, actuation of the second controller causes the proximal movement of the proximal capsule-portion, and

the tool automatically unlocks the third state by automatically making the second lock unlockable.

16. The apparatus according to claim 15, wherein, in the third state of the tool, further actuation of the first controller causes the second distal movement of the distal capsule-portion.

17. The apparatus according to claim 15, wherein the one or more controllers further comprise a third controller, and wherein, in the third state of the tool, actuation of the third controller causes the second distal movement of the distal capsule-portion.

18. The apparatus according to claim 13, wherein the implant is for use at a native mitral valve of a subject, and wherein:

the first part of the implant comprises an upstream support portion, configured to be placed against an upstream surface of the native mitral valve,

the second part of the implant comprises a downstream end of the implant, and a plurality of flanges (i) disposed longitudinally between the upstream support portion and the downstream end, and (ii) configured to engage leaflets of the native mitral valve; and

the implant is housed by the delivery capsule such that the first distal movement of the distal capsule-portion unhouses, from the distal capsule-portion, the plurality of flanges, but not the downstream end of the implant.

19. The apparatus according to claim 18, wherein the implant is housed by the delivery capsule such that the second distal movement of the distal capsule-portion unhouses, from the distal capsule-portion, the downstream end of the implant.

20. The apparatus according to claim 18, wherein the implant is housed by the delivery capsule such that the proximal movement of the proximal capsule-portion unhouses, from the proximal capsule-portion, the upstream support portion.

21. The apparatus according to claim 18, wherein the implant comprises:

a valve frame that comprises;

a tubular portion shaped to define a lumen therethrough, and

the upstream support portion, extending from an upstream end of the tubular portion;

an outer frame that circumscribes the tubular portion, and comprises the plurality of flanges; and

a plurality of prosthetic leaflets, coupled to the tubular portion within the lumen.

22. The apparatus according to claim 21, wherein the second part of the implant comprises at least part of the tubular portion.

23-36. -36. (canceled)