Adjustable self-locking papillary muscle band

• US 10,548,732 B2
• Filed: 10/22/2018
• Issued: 02/04/2020
• Est. Priority Date: 10/23/2017
• Status: Active Grant

• Current Assignee: Cardiac Success Ltd.
• Original Assignee: Cardiac Success Ltd.
• Inventors: Neustadter, David
• Primary Examiner(s): Ganesan, Suba
• Application Number:
  US16/166,291
• Publication Number:
  US 20190117399A1
• Time in Patent Office: 470 Days
• CPC Class Codes: A61F 2/2442 Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2454 Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2/246 Devices for obstructing a leak through a native valve in a closed condition
• 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 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2230/0065 toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2250/001 for adjusting a diameter

Abstract

Embodiments of the present disclosure include a device for repositioning papillary muscles. The device may comprise a band configured to encircle a cluster of papillary muscles. The cluster of papillary muscles may have an outer peripheral boundary defined by the encircling band, and the band may comprise a first end and a second end. The device may further comprise an adjustable clasp coupled to a location proximate the first end of the band. The clasp may be configured to transition from an open configuration to a closed configuration to connect the second end of the band to the first end of the band, thereby forming a loop. The clasp may be selectively actuatable to adjust a length of the loop.

Claims

1. A cardiac device, comprising:

a band configured to form a loop within a heart, the band defining a lumen extending at least partially therethrough along an elongated axis of the band, wherein the band includes a first end, a second end configured to be received within the lumen via a first opening in the first end, and a side wall opening between the first end and the second end, the side wall opening providing access to the lumen; and

an actuatable clasp configured to transition from an open configuration to a closed configuration for forming a fixed length loop after the second end is inserted into the first end, and wherein the clasp is configured for actuation via a catheter passing through the side wall opening,

wherein the actuatable clasp is configured to be held in the open configuration by a clasp retainer associated with the clasp; and

wherein the actuatable clasp is configured such that retraction of the clasp retainer from the clasp results in the clasp returning to its closed configuration.

2. The cardiac device of claim 1, wherein:

the actuatable clasp includes a plurality of spikes protruding radially inward such that, in the closed configuration, the spikes are configured to grasp the band therebetween.

3. The cardiac device of claim 2, wherein the actuatable clasp is formed from a cut nitinol tube, and the spikes of the clasp are biased radially inwards towards the closed configuration.

4. The cardiac device of claim 1, wherein the actuatable clasp includes metal.

5. The cardiac device of claim 1, wherein:

the loop is configured to encircle a cluster of papillary muscles, the cluster having an outer peripheral boundary defined by the encircling band, and an inner region on sides of the papillary muscles opposite the outer peripheral boundary; and

the band is configured to pull the papillary muscles toward each other such that the band contacts the outer peripheral boundary of the papillary muscles without contacting the inner region and such that the inner region is devoid of any portion of the band.

6. The cardiac device of claim 5, wherein:

the band is further configured to pull the papillary muscles toward each other, thereby decreasing a distance between opposing surfaces of the papillary muscles; and

the clasp is selectively actuatable to adjust a length of the loop.

7. The cardiac device of claim 5, wherein the cluster of papillary muscles includes two or more papillary muscles within a ventricle of the heart.

8. The cardiac device of claim 1, wherein a length of the loop is adjustable over a range of at least 8 mm.

9. The cardiac device of claim 1, wherein:

the band includes a plurality of graspable elements proximate the second end of the band, forming protrusions between which the clasp is configured to lock when in its closed configuration, the graspable elements being configured for passage through the clasp in both a first direction and a second direction opposite the first direction when the clasp is in its open configuration, and being configured to prevent passage through the clasp in the second direction when the clasp is in its closed configuration.

10. The cardiac device of claim 1, wherein a width of the band varies along different portions of a length of the band.

11. The cardiac device of claim 1, wherein the actuatable clasp is further configured to be actuated within a heart, via a catheter, from outside of a body.

12. The cardiac device of claim 1, wherein the band is further configured to be passed through a plurality of spaces among trabeculae between the papillary muscles and a wall of a ventricle.

13. The cardiac device of claim 1, wherein the actuatable clasp is located within the lumen.

14. A cardiac device, comprising:

a band configured to form a loop within a heart, the band defining a lumen extending at least partially therethrough along an elongated axis of the band, wherein the band includes a first end, a second end configured to be received within the lumen via a first opening in the first end, and a side wall opening between the first end and the second end, the side wall opening providing access to the lumen; and

an actuatable clasp configured to transition from an open configuration to a closed configuration for forming a fixed length loop after the second end is inserted into the first end, and wherein the clasp is configured for actuation via a catheter passing through the side wall opening,

wherein the clasp is selectively actuatable to enable adjustment of a length of the loop,

wherein the actuatable clasp is configured to be held in the open configuration by a clasp retainer associated with the clasp; and

wherein the clasp is configured such that retraction of the clasp retainer from the clasp results in the clasp returning to its closed configuration.

15. The cardiac device of claim 14, wherein the length of the loop is adjustable over a range of at least 8 mm.

16. The cardiac device of claim 14, wherein:

the actuatable clasp includes a plurality of spikes protruding radially inward such that, in the closed configuration, the spikes are configured to grasp the band therebetween.

17. The cardiac device of claim 14, wherein:

the loop is configured to encircle a cluster of papillary muscles, the cluster having an outer peripheral boundary defined by the encircling loop, and an inner region on sides of the papillary muscles opposite the outer peripheral boundary; and

the band is configured to pull the papillary muscles toward each other such that the band contacts the outer peripheral boundary of the papillary muscles without contacting the inner region and such that the inner region is devoid of any portion of the band.

18. The cardiac device of claim 14, wherein the band is further configured to be passed through a plurality of spaces among trabeculae between the papillary muscles and a wall of a ventricle.

19. A cardiac device, comprising:

a band configured to form a loop within a heart, the band defining a lumen extending at least partially therethrough along an elongated axis of the band, wherein the band includes a first end, a second end configured to be received within the lumen via a first opening in the first end, and a side wall opening between the first end and the second end, the side wall opening providing access to the lumen; and

an actuatable clasp configured to transition from an open configuration to a closed configuration for forming a fixed length loop after the second end is inserted into the first end, and wherein the clasp is configured for actuation via a catheter passing through the side wall opening,

wherein the band includes a plurality of graspable elements proximate the second end of the band, forming protrusions between which the clasp is configured to lock when in its closed configuration, the graspable elements being configured for passage through the clasp in both a first direction and a second direction opposite the first direction when the clasp is in its open configuration, and being configured to prevent passage through the clasp in the second direction when the clasp is in its closed configuration.