METHODS, SYSTEMS AND DEVICES FOR CARDIAC VALVE REPAIR

• US 20110066233A1
• Filed: 01/19/2010
• Published: 03/17/2011
• Est. Priority Date: 02/07/2005
• Status: Active Grant

• Current Assignee: Evalve, Inc. (Abbott Laboratories Incorporated)
• Original Assignee: Evalve, Inc. (Abbott Laboratories Incorporated)
• Inventors: Sarabia, Jaime E., Dell, Kent D., Ellis, Kristin E., Chakravarthy, Jayanth, Tyler, Steven A., Thornton, Troy L., Goldfarb, Eric A.
• Granted Patent: US 8,470,028 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• 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 17/08 Wound clamps or clips, i.e. not or only partly penetrating the tissue suture bridges A61B17/0466; Devices for bringing together the edges of a wound
• CPC Class Codes: A61B 17/083 Clips, e.g. resilient
• CPC Class Codes: A61B 17/29 Forceps for use in minimally invasive surgery
• CPC Class Codes: A61B 17/295 combined with cutting implements
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00477 Coupling A61B2017/0046 takes precedence
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/00876 magnetic
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0412 having anchoring barbs or pins extending outwardly from suture anchor body
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening lateral eyelet for attaching suture to needle A61B2017/06019
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0419 H-fasteners
• CPC Class Codes: A61B 2017/0427 : having anchoring barbs or pins extending outwardly from the anchor body
• CPC Class Codes: A61B 2017/0435 : the barbs being separate elements mechanically linked to the anchor, e.g. by pivots
• CPC Class Codes: A61B 2017/0441 : the shaft being a rigid coil or spiral
• CPC Class Codes: A61B 2017/0445 : cannulated, e.g. with a longitudinal through-hole for passage of an instrument
• CPC Class Codes: A61B 2017/0454 : the anchor being crimped or clamped on the suture
• CPC Class Codes: A61B 2017/0464 : for soft tissue
• CPC Class Codes: A61B 2017/048 : for reducing heart wall tension, e.g. sutures with a pad on each extremity
• CPC Class Codes: A61B 2017/0496 : for tensioning sutures
• CPC Class Codes: A61B 2017/0647 : having one single leg, e.g. tacks
• CPC Class Codes: A61B 2017/12018 : Elastic band ligators
• CPC Class Codes: A61B 2017/22044 : with a pointed tip
• CPC Class Codes: A61F 2/2412 : with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• 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 2/2463 : Implants forming part of the valve leaflets
• CPC Class Codes: A61F 2/2487 : Devices within the heart chamber, e.g. splints
• CPC Class Codes: A61F 2002/249 : Device completely embedded in the heart wall
• CPC Class Codes: A61F 2002/30079 : magnetic
• CPC Class Codes: A61F 2210/009 : magnetic
• CPC Class Codes: A61F 2220/0016 : with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2250/0003 : having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/0007 : for adjusting length

Abstract

Disclosed are devices and methods for treating regurgitation through a valve in the heart. The devices can include an expandable, fluid-tight bladder configured to be deployed between valve leaflets of the heart valve. The bladder can include an upper portion that extends into the atrium of the heart; a lower portion that extends into the ventricle of the heart; and a middle portion positionable within the line of valve leaflet coaptation that provides a sealing surface for one or more of the leaflets.

Claims

1. A device for treating regurgitation through a valve in a heart, the heart having an atrium fluidically coupled to a ventricle by the valve, the valve including at least two leaflets which coapt along a line of coaptation, the device comprising:

an expandable, fluid-tight bladder configured to be deployed between valve leaflets of the heart valve, the bladder comprising;

an upper portion that extends into the atrium of the heart;

a middle portion positionable within the line of valve leaflet coaptation, wherein the middle portion provides a sealing surface for one or more of the leaflets;

a lower portion that extends into the ventricle of the heart,

wherein the upper portion and lower portions expand and contract passively upon changes in heart chamber pressure differential; and

a proximal anchoring mechanism comprising;

at least one pair of angled clamping wires coupled to and extending proximally from a proximal end region of the bladder; and

a sliding sleeve having an inner diameter that is smaller than an outer diameter of the bladder in an expanded configuration, wherein the pair of angled clamping wires extend through the inner diameter of the sliding sleeve.

2. The device of claim 1, wherein the upper portion of the bladder blocks a valve leaflet from flailing into the atrium.

3. The device of claim 1, wherein the bladder is fluid-filled.

4. The device of claim 1, wherein the bladder further comprises one or more anchors securing the bladder to a location in the heart that is distal to an annulus of the valve.

5. The device of claim 1, wherein the bladder further comprises one or more anchors securing the bladder to an annulus of the valve.

6. The device of claim 5, wherein the one or more anchors secure the middle portion in a stationary position to the annulus of the valve.

7. The device of claim 1, wherein expansion of the bladder moves the sliding sleeve in a proximal direction and the inner diameter of the sliding sleeve urges the pair of angled clamping wires towards one another.

8. The device of claim 7, wherein the pair of angled clamping wires removably capture at least a portion of the atrial wall between them.

9. The device of claim 1, wherein the expandable bladder further comprises a valve for selectively filling and depleting filling material into and out of the bladder such that the device can be repositioned, redeployed and removed.

10. A device for treating regurgitation through a gap in a valve in a heart, the heart having an atrium fluidically coupled to a ventricle by the valve, the valve including at least two leaflets which coapt along a line of coaptation, the device comprising:

a frame sized to fit within a heart chamber;

a pair of arms moveably coupled to the frame, the arms being moveable between a fluid flow-blocking position during systole into a fluid flow-allowing position during diastole;

an anchoring mechanism having a tether and an expandable portion positioned in the coronary sinus, wherein the tether interconnects the frame to the expandable portion; and

a compliant membrane covering the frame and at least a portion of the pair of arms.

11. The device of claim 10, wherein the pair of arms are coupled to the frame by a hinge.

12. The device of claim 10, wherein the frame further comprises a stationary portion coupled to a proximal portion of the pair of arms, wherein the stationary portion is positioned above the level of the annulus and wherein the stationary portion has a long axis oriented orthogonal to the line of coaptation.

13. The device of claim 12, wherein the tether connects to a region of the stationary portion near an outer edge of the gap.

14. The device of claim 12, wherein the long axis of the stationary portion has a length sufficient to contact an anterior and posterior annulus.

15. The device of claim 10, wherein the device can be repositioned in the heart, redeployed in the heart and removed from the heart.

16. A device for treating regurgitation through a gap in a valve in a heart, the heart having an atrium fluidically coupled to a ventricle by the valve, the valve including at least two leaflets which coapt along a line of coaptation, the device comprising:

a frame sized to fit within a heart chamber;

a pair of arms moveably coupled to the frame, the arms being moveable between a fluid flow-blocking position during systole into a fluid flow-allowing position during diastole;

an anchoring mechanism having a tether and an anchor positioned in a wall of the ventricle, wherein the tether interconnects the frame to the anchor; and

a compliant membrane covering the frame and at least a portion of the pair of arms.

17. The device of claim 16, wherein the pair of arms are coupled to the frame by a hinge.

18. The device of claim 16, wherein the frame further comprises a stationary portion coupled to a proximal portion of the pair of arms, wherein the stationary portion is positioned above the level of the annulus and wherein the stationary portion has a long axis oriented orthogonal to the line of coaptation.

19. The device of claim 18, wherein the tether connects to the frame at a lower surface of the stationary portion.

20. The device of claim 18, wherein the long axis of the stationary portion has a length sufficient to contact an anterior and posterior annulus.

21. The device of claim 16, wherein the device can be repositioned in the heart, redeployed in the heart and removed from the heart.

22. A method for treating regurgitation through a valve in a heart, the heart having an atrium fluidically coupled to a ventricle by the valve, the valve including at least two leaflets which coapt along a line of coaptation, the method comprising:

introducing percutaneously a medical device system into a patient'"'"'s heart to a vicinity of a gap within the line of coaptation of the valve, the medical device system comprising;

a steerable guide catheter configured for delivery through the patient'"'"'s vasculature to the vicinity of the gap;

a retractable sheath moveably disposed over a blocker comprising an expandable, fluid-tight bladder, wherein the blocker is configured to be compressed by the sheath into a delivery configuration;

using the guide catheter to position a middle portion of the blocker within the gap along the line of coaptation, an upper portion of the blocker extending into the atrium of the heart; and

a lower portion of the blocker extending into the ventricle of the heart;

retracting the sheath to release the blocker from compressive forces maintaining the blocker in the delivery configuration;

expanding the blocker such that the middle portion of the blocker provides a sealing surface for one or more of the valve leaflets, wherein the upper portion and lower portions expand and contract passively upon changes in heart chamber pressure differential;

detaching the blocker from the catheter; and

retracting the catheter and the sheath from the heart.

23. The method of claim 22, wherein the upper portion blocks a valve leaflet from flailing into the atrium.

24. The method of claim 22, further comprising deploying one or more anchors configured to secure the blocker to one or more locations in the heart that are proximal to, distal to or at the level of the valve annulus.

25. The method of claim 24, wherein the one or more locations are positioned distal to an annulus of the valve.

26. The method of claim 25, wherein the one or more locations are positioned on the exterior of the heart near the apex.

27. The method of claim 25, wherein the one or more anchors comprise a screw-type anchor coupled to the blocker and wherein deploying the one or more anchors comprises rotating the catheter to advance the screw-type anchor into the one or more locations.

28. The method of claim 24, wherein the one or more locations are positioned on an annulus of the valve.

29. The method of claim 28, wherein the one or more anchors secure the middle portion in a stationary position to the annulus of the valve.

30. The method of claim 24, wherein the one or more locations are positioned proximal to an annulus of the valve.

31. The method of claim 30, wherein the one or more anchors comprises:

at least one pair of angled clamping wires coupled to and extending proximally from the upper portion of the blocker; and

a sliding sleeve having an inner diameter that is smaller than an outer diameter of the upper portion of the blocker when the blocker is in an expanded configuration, wherein the pair of angled clamping wires extend through the inner diameter of the sliding sleeve.

32. The method of claim 31, wherein deploying one or more anchors comprises expanding the expandable region of the blocker and moving the sliding sleeve in a proximal direction, the inner diameter of the sliding sleeve urging the pair of angled clamping wires towards one another.

33. The method of claim 32, wherein the pair of angled clamping wires removably captures at least a portion of the atrial wall between them.

34. The method of claim 30, wherein the one or more locations are positioned on the septum between the left and right atria.

35. The method of claim 22, wherein retracting the sheath to release the expandable region of the blocker expands the expandable region.

36. The method of claim 22, wherein expanding the blocker comprises filling the blocker with a fluid.

37. The method of claim 36, wherein filling the blocker with a fluid comprises extending the catheter through a flow restriction mechanism in a neck region of the blocker to selectively fill the blocker with filling material delivered through the catheter.

38. The method of claim 37, wherein the flow restriction mechanism comprises a one-way valve and wherein detaching the blocker from the catheter comprises withdrawing the catheter from the one-way valve.

39. The method of claim 37, wherein the flow restriction mechanism comprises a snap ring surrounding the neck region of the blocker and wherein detaching the blocker from the catheter comprises withdrawing the catheter from the neck region and releasing the snap ring to compress the neck region of the blocker.