Percutaneous transcatheter repair of heart valves via trans-apical access

• US 9,402,721 B2
• Filed: 02/15/2012
• Issued: 08/02/2016
• Est. Priority Date: 06/01/2011
• Status: Active Grant

• Current Assignee: ValCare Medical, Inc.
• Original Assignee: ValCare, Inc.
• Inventors: Buchbinder, Maurice, Shaolian, Samuel M.
• Primary Examiner(s): Sharma, Yashita
• Assistant Examiner(s): Preston, Rebecca
• Application Number:
  US13/397,545
• Publication Number:
  US 20120310330A1
• Time in Patent Office: 1,630 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/8855 inflatable, e.g. kyphoplasty balloons
• CPC Class Codes: A61B 2017/0474 Knot pushers
• CPC Class Codes: A61B 2018/0025 Multiple balloons
• CPC Class Codes: A61F 2/2433 using balloon catheter
• 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 2/2448 D-shaped rings
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2210/0023 operated at different temperatures whilst inside or touching the human body, heated or cooled by external energy source or cold supply
• CPC Class Codes: A61F 2210/0033 electrically, e.g. heated by resistor
• CPC Class Codes: A61F 2210/0066 shrinkable
• 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 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/0008 elliptical or oval
• CPC Class Codes: A61F 2250/001 : for adjusting a diameter
• CPC Class Codes: A61M 2025/1047 : having centering means, e.g. balloons having an appropriate shape
• CPC Class Codes: A61M 2025/1061 : having separate inflations tubes, e.g. coaxial tubes or tubes otherwise arranged apart from the catheter tube
• CPC Class Codes: A61M 2025/1072 : having balloons with two or more compartments
• CPC Class Codes: A61M 25/1011 : Multiple balloon catheters

Abstract

Apparatus, systems, and methods are provided for repairing heart valves through percutaneous transcatheter delivery and fixation of annuloplasty rings to heart valves via a trans-apical approach to accessing the heart. A guiding sheath may be introduced into a ventricle of the heart through an access site at an apex of the heart. A distal end of the guiding sheath can be positioned retrograde through the target valve. An annuloplasty ring arranged in a compressed delivery geometry is advanced through the guiding sheath and into a distal portion of the guiding sheath positioned within the atrium of the heart. The distal end of the guiding sheath is retracted, thereby exposing the annuloplasty ring. The annuloplasty ring may be expanded from the delivery geometry to an operable geometry. Anchors on the annuloplasty ring may be deployed to press into and engage tissue of the annulus of the target valve.

Claims

1. A method for percutaneous transcatheter repair of a target valve in a heart via trans-apical access, the method comprising:

introducing a distal end of a guiding sheath into a ventricle of the heart through an access site at an apex of the heart;

positioning the distal end of the guiding sheath retrograde through the target valve, wherein the target valve is positioned between the ventricle and an atrium of the heart, and wherein the distal end and a distal portion of the guiding sheath are positioned within the atrium of the heart;

inserting an annuloplasty ring arranged in a compressed delivery geometry into the guiding sheath;

advancing the annuloplasty ring through the guiding sheath and into the distal portion of the guiding sheath positioned within the atrium of the heart;

retracting the distal end of the guiding sheath back through the target valve and into the ventricle of the heart, thereby exposing the annuloplasty ring;

expanding the annuloplasty ring from the compressed delivery geometry to an operable geometry;

deploying anchors of the annuloplasty ring, the anchors configured to be pressed into and engage tissue of an annulus of the target valve; and

retracting the guiding sheath from the access site of the heart,

wherein the annuloplasty ring is segmented and in the compressed delivery geometry around a balloon assembly, the balloon assembly comprising;

an upper balloon, a lower balloon, and a recess configured to accommodate the annuloplasty ring in the compressed delivery geometry, the upper balloon defining an upper surface of the recess and the lower balloon defining a lower surface of the recess, and wherein expanding the annuloplasty ring comprises inflating the upper balloon and the lower balloon of the balloon assembly,

wherein the balloon assembly further comprises a double lumen shaft coupling together the upper balloon and the lower balloon, the double lumen shaft having a first lumen coupled to and configured to direct a fluid or gas into the upper balloon from outside the heart and having a second lumen coupled to and configured to direct a fluid or gas into the lower balloon from outside the heart, wherein the method further comprises;

inflating, at least partially, the upper balloon of the balloon assembly to a diameter larger than a diameter of the annulus of the target valve;

retracting the balloon assembly to position the annuloplasty ring planar to a plane of the annulus of the target valve above an atrial surface of the annulus, the inflated upper balloon pressing against the annulus of the target valve to guide positioning of the annuloplasty ring; and

inflating the lower balloon of the balloon assembly to at least partially expand the annuloplasty ring from the compressed delivery geometry to the operable geometry.

2. The method of claim 1, wherein

the upper balloon is configured to inflate to restrict distal shifting of the annuloplasty ring relative to the recess as a delivery assembly is advanced and positioned in the target valve,

the lower balloon is configured to inflate to restrict proximal shifting of the annuloplasty ring relative to the recess as the delivery assembly is advanced and positioned in the target valve;

wherein the upper balloon and the lower balloon of the balloon assembly are more pliant than the recess of the balloon assembly to inflate and expand more readily than the recess.

3. The method of claim 1, further comprising further inflating both the upper balloon and the lower balloon to further expand a diameter of the annuloplasty ring in the operable geometry and drive the anchors into tissue of the annulus such that the anchors engage the annulus.

4. The method of claim 1, further comprising decreasing a diameter of the annuloplasty ring after the anchors are engaging tissue of the annulus, thereby decreasing a diameter of the annulus of the target valve.

5. The method of claim 4, wherein decreasing the diameter of the annuloplasty ring comprises drawing together free ends of the annuloplasty ring to snap the free ends together and draw the annuloplasty ring into a closed configuration forming a complete ring.

6. The method of claim 5, wherein drawing together the free ends is accomplished by pulling a suture, connected to the ring through the guiding sheath, to couple the ends of the ring together and cinch the target valve annulus to a desired size.

7. The method of claim 4, wherein the annuloplasty ring comprises shape memory material, and wherein decreasing the diameter of the annuloplasty ring comprises activating a heating element to heat the shape memory material of the annuloplasty ring.

8. The method of claim 7, wherein cinching is accomplished by activating a cinching mechanism configured to cinch the annuloplasty ring and reduce the diameter of the annuloplasty ring.

9. The method of claim 4, wherein decreasing the diameter of the annuloplasty ring comprises using induction to activate a mechanism to decrease the diameter of the annuloplasty ring.

10. The method of claim 1, wherein the annuloplasty ring in the compressed delivery geometry is compressed within a plane transverse to a longitudinal axis of the guiding sheath.

11. The method of claim 1, wherein deploying the anchors of the annuloplasty ring includes pulling one or more sutures, the one or more sutures are connected to the annuloplasty ring through the guiding sheath, to deploy the anchors from the annuloplasty ring as the annuloplasty ring is pressed against the target valve annulus.

12. The method of claim 11, wherein each of the anchors includes a superelastic shape memory material that self-propels the anchors into the tissue of the annulus of the target valve.