Devices and Methods for Treating Cardiomyopathy

• US 20110015476A1
• Filed: 10/14/2009
• Published: 01/20/2011
• Est. Priority Date: 03/04/2009
• Status: Abandoned Application

• Current Assignee: Tendyne Holdings Inc. (Abbott Laboratories Incorporated)
• Original Assignee: Tendyne Holdings Inc. (Abbott Laboratories Incorporated)
• Inventors: Franco, Jeff
• Application Number:
  US12/589,544
• Publication Number:
  US 20110015476A1
• Time in Patent Office: Days
• US Class Current: 600/37
• 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 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/0412 having anchoring barbs or pins extending outwardly from suture anchor body
• CPC Class Codes: A61B 2017/0427 having anchoring barbs or pins extending outwardly from the anchor body
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61F 2/2487 Devices within the heart chamber, e.g. splints
• CPC Class Codes: A61F 2002/3055 for adjusting length
• CPC Class Codes: A61F 2250/0007 for adjusting length

Abstract

This application relates to cardiac medical devices, and specifically to adjustable tensioning devices for tissue anchors, to the intraventricular cardiac anchoring or banding devices themselves, to devices and methods for controlling the depth of penetration of tissue anchors, to devices and methods for the joining of both papillary muscles to the mitral valve, to devices and methods for non-invasive “sling” or “loop” tethering of papillary muscles, to devices and methods for establishing suction prior to and during tissue anchor implant, to a double-barreled needle delivery device, and to a method of remodelling the heart muscle by implanting one or more tethers, and then periodically reducing the tether distance over time.

Claims

1. An adjustable in vivo tensioning actuator for connecting at least two implantable tissue tethers, comprising:

a housing having one or more apertures capable of accepting an implantable tissue tether or a tissue tether comprising a band or sling, and an adjustment mechanism that attaches to each tissue tether during an in vivo endoscopic procedure and secures the tether to define the length of the tether and thereby the distance between the tissue attachments, wherein the tensioning actuator is reversibly adjustable without need for reattachment of the tethers to the tissues being manipulated.

2. The adjustable in vivo tensioning actuator of claim 1, further comprising wherein the adjustment mechanism comprises an axially disposed screw within said housing, wherein said tissue tether winds about said axially disposed screw and said screw operates as a rotary shaft.

3. The adjustable in vivo tensioning actuator of claim 1, further comprising wherein the adjustment mechanism comprises a common spring-loaded spooling mechanism attached to the housing by a lateral axle, wherein the tissue tethers are fed into the housing via separate opposing apertures and the tissue tethers wind about the common spring-loaded spooling mechanism.

4. The adjustable in vivo tensioning actuator of claim 1, further comprising wherein the adjustment mechanism comprises a reversible clamp.

5. The adjustable in vivo tensioning actuator of claim 1, further comprising wherein there are three or more tissue tethers, each of said tethers attached to a tissue anchor.

6. An adjustable tether implant, comprising:

at least two elongated pieces of a medically appropriate implantable material for mechanically connecting two or more tissues together at a predefined distance, at least one tissue anchor attached to each of said elongated pieces, and the adjustable tensioning actuator of claim 1 connected to the at least two elongated pieces for adjusting the distance between the tissue anchors, wherein the tensioning actuator is reversibly adjustable without need for reinstallation of the tether implant.

7. The adjustable tether implant of claim 6, further comprising wherein the adjustment mechanism comprises an axially disposed screw within said housing, wherein said implantable tissue tether winds about said axially disposed screw and said screw operates as a rotary shaft.

8. The adjustable tether implant of claim 6, further comprising wherein the adjustment mechanism comprises a common spring-loaded spooling mechanism attached to the housing by a lateral axle, wherein the implantable tissue tethers are fed into the housing via separate opposing apertures and the implantable tissue tethers wind about the common spring-loaded spooling mechanism.

9. The adjustable tether implant of claim 6, further comprising wherein the adjustment mechanism comprises a reversible clamp.

10. The adjustable tether implant of claim 6, further comprising wherein there are three or more implantable tissue tethers, each of said tethers attached to a tissue anchor.

20. The method of claim 19, further comprising the steps of:

threading the sling or band of medically implantable material between the papillary muscle and the ventricle wall to create a loop, cinching said loop in front of the papillary muscle using a clamp or similar crimping device, and allowing it to interact with the adjustable tensioning device of claim 1.

11. A tissue anchor for implantable tethers, comprising:

an anchor housing having a tip end, a wire-access end, and a tether fastening means, said housing defining an external shell and an inner cavity, at least one channel within said inner cavity, said at least one channel having a release wire partially disposed therein, said release wire having at one terminus a release loop located outside the anchor housing, and at the other release wire terminus the release wire is attached to a slidable filament core within said inner cavity, said slidable filament core having one or more filaments moveably attached thereto and extending from said inner cavity to outside the anchor housing for mechanical interaction with the tissue such that when the one or more moveable filaments are in a fully-extended open position they operate to secure the anchor to the tissue and when the one or more moveable filaments are in a folded closed position they do not securely engage the tissue, the slidable filament core having a disengagable locking mechanism such that when the release wire is pulled away from the anchor housing the slidable filament core slides within said inner cavity and the moveable filaments retract to a folded closed position enabling removal of the tissue anchor.

12. The tissue anchor of claim 11, further comprising wherein the moveable filaments have a tapered shape.

13. The tissue anchor of claim 11, further comprising wherein the slidable filament core is attached to a spring which is mounted within the tip of the inner cavity.

14. The tissue anchor of claim 11, further comprising wherein the inner cavity comprises two channels each channel having a branch wire from a split release wire comprised of a single external release wire at the release loop terminus and two internal branches of the release wire attached to the slidable filament core.

15. The tissue anchor of claim 11, further comprising wherein the slidable filament core has a limiting mechanism wherein the filaments cannot rotate away from the tissue anchor housing beyond 90 degrees from the folded closed position when the tissue anchor is in the secure fully-extended open position.

16. A method for placing an anchor device within tissue, comprising the step of:

inserting the tissue anchor of claim 11 into the target tissue wherein the tissue anchor is in a deployed position such that the tissue engaging filaments extend from the anchor housing in a manner to secure the tissue anchor to the tissue.

17. A method for standardizing the depth of penetration of an anchor device within tissue, comprising the step of:

providing a rim or collar device around the housing of the tissue anchor of claim 11, wherein the rim or collar is located behind the tissue engaging filaments to prohibit the anchor from penetrating the tissue beyond a preset depth.

18. A method of removing an anchor device from within tissue, comprising the steps of:

pulling the release wire of the tissue anchor of claim 11 to retract the tissue engaging filaments from the tissue and removing the anchor from said tissue.

19. A method of tethering cardiac papillary muscles, comprising the step of:

threading a sling or band made of medically implantable material around a papillary muscle, wherein said threading allows tethering of said papillary muscle, either to another papillary muscle or to other tissue within the ventricle, wherein said threading provides tethering without requiring implantation anchors or other elements requiring the piercing of muscle tissue.

21. An anchor system for allowing synchronous movement of tethered tissue, comprising:

two or more medically implantable tissue anchors in combination, wherein said tissue anchors have one or more hook or drawstring elements attached thereby allowing each tissue anchor to become interjoined with at least one opposing tissue anchor, wherein said one or more hook or drawstring elements allow the tissue to completely join together, allowing the tissue to move in a synchronous manner.

22. The anchor system of claim 21, further comprising wherein the tethered tissue is papillary tissue within the left ventricle.

23. A medically implantable tissue anchor that forms a circle or semi circle upon implantation, wherein the tissue anchor possesses barbs that form a full 360 degree circle, wherein there is no part of the barb exposed to inside of the heart or tissue should a partial implant be the result of the implantation procedure.

24. An anchor system for reduction of mitral regurgitation, comprising:

at least two tethers that are attached using tissue anchors to the posterior and the anterior papillary muscle, and a third anchor attached to the top of the left ventricle between the aortic valve and the mitral valve or across the left ventricle to the septum, and an adjustor on that third tether that allows the papillary muscle tethers to be drawn toward the mitral valve, wherein the reduction in papillary to mitral valve distance reduces/eliminates mitral regurgitation.

25. A method of implanting a tissue anchor using suction to verify target muscle and reduce damage to surrounding tissue, comprising:

providing suction within the implantation canula of an endoscopy system during a cardiac tethering procedure, wherein the suction provides enhanced muscle contact with the implantation canula.

26. An adjustable tether implant, with a slidable core, adjustable whether by tensioning or loosing, that is implanted for 30-45 days prior to tightening to allow for the formation of adequate fibrous tissue, increasing the tensile strength of the anchor, that is adjustable in 1 mm increments via an adjustor mechanism on subsequent procedures for the purpose of tightening or loosening the tensile strength of the device, for the purpose of resisting diastolic pressure on the heart.

27. The adjustable tether implant of claim 26, further comprising wherein the slidable core has 2, 3 or four layers of slidable filament, so allow for maximum tightening that can be ratcheted, tightening or loosening the tensioning element or tendon via small, incremental rachets within the slidable filament.

28. The adjustable tether implant of claim 27, further comprising wherein one or more anchors can be released after implant or by abandoning the procedure, leaving the anchor permanently implanted in the heart.