Systems and methods for delivery of annuloplasty rings

• US 10,166,100 B2
• Filed: 03/17/2014
• Issued: 01/01/2019
• Est. Priority Date: 03/15/2013
• Status: Active Grant

• Current Assignee: ValCare Medical, Inc.
• Original Assignee: ValCare, Inc.
• Inventors: Yellin, Nadav, Shaolian, Samuel M., Dumontelle, Jeffrey P.
• Primary Examiner(s): Fishback, Ashley
• Application Number:
  US14/775,735
• Publication Number:
  US 20160022419A1
• Time in Patent Office: 1,751 Days
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/0641 having at least three legs as part of one single body
• CPC Class Codes: A61F 2/2448 D-shaped rings
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0033 made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2230/0034 D-shaped
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2250/0001 Means for transferring electromagnetic energy to implants
• CPC Class Codes: A61F 2250/0004 adjustable
• CPC Class Codes: A61F 2250/0006 for adjusting angular orientation
• CPC Class Codes: A61F 2250/0007 for adjusting length

Abstract

Systems and methods for percutaneous, transcatheter heart valve repair are disclosed. A system may include a catheter, an adjustable ring, and a stabilizer. The adjustable ring may include a body member that is transitionable from an insertion geometry to an operable geometry. The insertion geometry may be configured to allow percutaneous passage of the ring into the heart. The operable geometry may have an expanded state to conform to an annulus of a target valve and a contracted state to reduce a diameter of the annulus. The adjustable ring may also include a plurality of anchors deployable in the operable geometry to engage the annulus. The stabilizer may include a plurality of prongs configured to engage the ring in the operable geometry within the heart to enable percutaneous manipulation of the ring to orient and position the ring in intimate contact with the annulus.

Claims

1. A system for percutaneous, transcatheter heart valve repair, the system comprising:

a catheter configured to provide percutaneous access into a heart of a patient;

an adjustable annuloplasty ring comprising;

a body member that is transitionable from an elongate insertion geometry to an annular operable geometry, the elongate insertion geometry configured to allow percutaneous passage of the annuloplasty ring, via the catheter, into the heart of a patient, and the annular operable geometry having an expanded state to conform to an annulus of a target valve of the heart and a contracted state to reduce a diameter of the annulus of the target valve,

a plurality of anchors deployable in the annular operable geometry to engage the annulus of the target valve; and

a stabilizer comprising a plurality of prongs configured to engage the annuloplasty ring after the body member has transitioned into the annular operable geometry within the heart to enable percutaneous manipulation of the ring to orient and position the ring in intimate contact with the annulus of the target valve.

2. The system of claim 1, wherein the stabilizer comprises an insertion geometry and an operable geometry, the insertion geometry including the plurality of prongs drawn together to allow percutaneous passage of the stabilizer, via the catheter, into the heart, the operable geometry including the plurality of prongs radiating outward to engage an annuloplasty ring in the annular operable geometry at a plurality of points.

3. The system of claim 1, wherein the stabilizer comprises two prongs to engage the annuloplasty ring at two points of contact.

4. The system of claim 3, further comprising a shuttle configured to releasably couple to the annuloplasty ring and provide a third point of contact in cooperation with the stabilizer to manipulate the annuloplasty ring.

5. The system of claim 1, wherein the stabilizer comprises three prongs to engage the annuloplasty ring at three points of contact.

6. The system of claim 1, wherein the stabilizer is configured for a retrograde approach through the target valve to engage the annuloplasty ring and pull the annuloplasty ring into intimate contact with the annulus of the target valve.

7. The system of claim 1, wherein the stabilizer is configured to engage the annuloplasty ring within the heart from above to push the annuloplasty ring into intimate contact with the annulus of the target valve.

8. The system of claim 1, further comprising a deployment handle configured to percutaneously manipulate the stabilizer when the stabilizer is positioned within the heart.

9. The system of claim 8, wherein the deployment handle is further configured to percutaneously deploy the adjustable annuloplasty ring within the heart.

10. The system of claim 8, wherein the deployment handle comprises:

a ring closure knob configured to close the annuloplasty ring, transitioning the annuloplasty ring from the elongate insertion geometry to the annular operable geometry;

a ring snap knob configured to snap together a first end and a second end of the annuloplasty ring;

an anchor deployment knob configured to deploy the plurality of anchors to fasten the annuloplasty ring to the annulus of the target heart valve;

an intimate contact adjustment knob configured to manipulate the stabilizer to manipulate the annuloplasty ring; and

a ring release knob configured to release the annuloplasty ring from the system.

11. The system of claim 1, further comprising an expansion tool deliverable through the catheter to the heart of the patient and configured to expand the annuloplasty ring in the annular operable geometry to an expanded state.

12. A method for percutaneous, transcatheter heart valve repair, the method comprising:

inserting a distal end of a catheter into a target valve;

guiding, via a delivery system, an annuloplasty ring in an elongate geometry from a proximal end of the catheter to the distal end such that the annuloplasty ring transitions to an annular operable geometry upon exiting the distal end of the catheter;

orienting, via a stabilizer portion of the delivery system, the annuloplasty ring in intimate contact with the annulus of the target valve prior to deploying a plurality of anchors, wherein the stabilizer portion of the delivery system engages the annuloplasty ring after transitioning into the annular operable geometry; and

deploying a plurality of anchors from the annuloplasty ring to engage an annulus of the target valve.

13. The method of claim 12, wherein orienting comprises:

manipulating the stabilizer via a stabilizer knob on a deployment handle of the delivery system to orient the annuloplasty ring.

14. The method of claim 12, further comprising:

expanding, via an expansion tool portion of the delivery system, the annuloplasty ring to an expanded state to conform to the annulus of the target valve.

15. The method of claim 14, wherein expanding comprises:

manipulating the expansion tool via an expansion tool knob on a deployment handle of the delivery system to expand the annuloplasty ring.

16. The method of claim 12, wherein guiding comprises:

manipulating a ring closure knob on a deployment handle of the delivery system to cause the annuloplasty ring to transition from the elongate geometry to the annular operable geometry.

17. The method of claim 12, further comprising:

manipulating a ring snap knob on a deployment handle of the delivery system to cause a first end and a second end of the annuloplasty ring to snap together after the annuloplasty knob transitions to the annular operable geometry.

18. The method of claim 12, further comprising:

releasing, via a ring release knob on a deployment handle of the delivery system, the annuloplasty ring from the delivery system.