DEVICE AND METHOD FOR TEMPORARY OR PERMANENT SUSPENSION OF AN IMPLANTABLE SCAFFOLDING CONTAINING AN ORIFICE FOR PLACEMENT OF A PROSTHETIC OR BIO-PROSTHETIC VALVE

• US 20120203336A1
• Filed: 02/03/2012
• Published: 08/09/2012
• Est. Priority Date: 04/10/2009
• Status: Active Grant

• Current Assignee: Lon Sutherland Annest
• Original Assignee: Lon Sutherland Annest
• Inventors: ANNEST, Lon Sutherland
• Granted Patent: US 9,011,522 B2
• Time in Patent Office: Days
• US Class Current: 623/2.36
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/00349 Needle-like instruments having hook or barb-like gripping means, e.g. for grasping suture or tissue A61B17/06066 takes precedence
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0427 having anchoring barbs or pins extending outwardly from the anchor body
• CPC Class Codes: A61B 2017/0441 the shaft being a rigid coil or spiral
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• 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 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• 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 2220/0008 Fixation appliances for connecting prostheses to the body
• 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 2250/0006 : for adjusting angular orientation
• CPC Class Codes: A61F 2250/006 : modular

Abstract

In a surgical method for improving cardiac function, an implantable scaffold Or valve support device is inserted inside a patient'"'"'s heart and attached to the heart in a region adjacent to a natural mitral or other heart valve. The scaffold or valve support device defines an orifice and, after the attaching of the scaffold or valve support device to the heart, or temporary support while native valve leaflets and/or subvalvular structures are captured, a prosthetic or bio-prosthetic valve seated in the orifice, and the native valve may be retracted into the scaffold/replacement assembly to create a gasket for sealing the complex.

Claims

1. A surgical method for improving cardiac function, comprising:

inserting an implantable scaffold or valve support device inside a patient;

after the inserting of said scaffold or valve support device inside the patient, attaching said scaffold or valve support device to the patient, said scaffold or valve support device defining an orifice; and

after the inserting of said scaffold or valve support device inside the patient, seating a prosthetic or bio-prosthetic valve in said orifice.

2. The method of claim 1 wherein the inserting of said scaffold or valve support device includes disposing said scaffold or valve support device inside an atrium, ventricle, or aorta of the patient'"'"'s heart, and wherein the attaching of said scaffold or valve support device includes attaching said scaffold or valve support device to a natural cardiac structure taken from the group consisting of a wall of said atrium and leaflets of a native valve.

3. The method of claim 2 wherein the attaching of said scaffold of valve support includes operatively securing said scaffold of valve support device at least indirectly to chordae tendineae of the heart.

4. The method of claim 3 wherein the securing of said scaffold or valve support device to the chordae tendineae includes attaching said scaffold or valve support device to the leaflets or subvalvular structures of said native valve.

5. The method of claim 4 wherein the inserting of said scaffold or valve support device inside the patient includes inserting said scaffold or valve support device inside the patient through a catheter and wherein the attaching of said scaffold of valve support to the patient includes:

manipulating a multiplicity of tethers or suspension elements extending through said catheter, to position said scaffold or valve support device in apposition to said native valve suspending or supporting said scaffold or support device in the patient proximately to said native valve; and

after the seating of said prosthetic or bio-prosthetic valve in said orifice, coupling said scaffold or valve support device and indirectly said prosthetic or bio-prosthetic valve at least indirectly to said native valve so that said scaffold or valve support device is in effective force-transmitting and effective fluid-sealing contact with said native valve and substantially fixedly attached to the patient.

6. The method of claim 5 wherein said scaffold or support device is provided with one or more tensile coupling elements, the suspending or supporting of said scaffold or support device including attaching ends of said one or more tensile coupling elements to a cardio-vascular wall proximate said native valve.

8. The method of claim 5 wherein the suspending or supporting of said scaffold or support device includes suspending said scaffold or heart valve support device temporarily by said tethers or suspension elements while said prosthetic or bio-prosthetic valve is deployed and said scaffold or valve support device is affixed at least indirectly to said native valve.

9. The method of claim 5 wherein said scaffold or valve support device carries at least one expandable member, the coupling of said scaffold or valve support device and said prosthetic or bio-prosthetic valve at least indirectly to said native valve including affixing said scaffold or valve support device to valve leaflets of said native valve, further comprising expanding said at least one expandable member to effectuate closure of a gap between said valve leaflets and thereby at least reduce peri-valvular leakage.

10. The method of claim 5 wherein the coupling of said scaffold or valve support device and said prosthetic or bio-prosthetic valve at least indirectly to said native valve includes affixing said scaffold or valve support device to valve leaflets or subvalvular structures of said native valve, further comprising deploying at least one approximation element into a plurality of mutually adjacent ones of said valve leaflets to effectuate closure of a gap between said valve leaflets and thereby at least reduce peri-valvular leakage and facilitate minimizing systolic anterior motion of the mitral leaflets.

11. The method of claim 5 wherein the coupling of said scaffold or valve support device to said native valve includes attaching distal ends of one or more coupling elements to said valve leaflets, said one or more coupling elements being coupled to said scaffold or valve support device, the coupling of said scaffold or valve support device to said native valve further including thereafter maintaining force on said one or more coupling elements while moving said scaffold or valve support member towards said native valve, thereby moving said scaffold or valve support device on the one hand and said valve leaflets on the other hand towards one another.

12. The method of claim 11 wherein the moving of said scaffold or valve support member and said prosthetic or bio-prosthetic valve on the one hand and said native valve on the other hand towards one another includes exerting a distally directed force on one or more elongate sleeves that surround respective ones of said one or more coupling elements and that extend through said catheter to said scaffold or valve support member.

13. The method of claim 12 wherein said one or more sleeves comprise respective ones of said tethers or suspension elements.

14. The method of claim 13, further comprising separating said tethers or suspension elements from said scaffold or valve support device and removing said tethers or suspension elements from the patient after coupling of said scaffold or valve support device and indirectly said prosthetic or bio-prosthetic valve to said valve leaflets.

15. The method of claim 14, further comprising separating proximal end portion and a distal end portion of each of said one or more coupling elements from one another and removing one of said proximal end portion and said distal end portion of each of said one or more coupling elements from the patient after coupling of said scaffold or valve support device and indirectly said prosthetic or bio-prosthetic valve to said valve leaflets or subvalvular structures, the other of said proximal end portion and said distal end portion of each of said one or more coupling elements remaining affixed to said scaffold or valve support device and said valve leaflets or subvalvular structures.

16. The method of claim 11, further comprising operating an incremental advancement device to prevent moving of said scaffold or valve support device away from said native valve during the coupling of said scaffold or valve support device and indirectly said prosthetic or bio-prosthetic valve to said valve leaflets.

17. The method of claim 5 wherein said scaffold or valve support device includes a plurality of affixation tension members, the coupling of said scaffold or valve support device and indirectly said prosthetic or bio-prosthetic valve to said valve leaflets including attaching said affixation tension members to said valve leaflets or subvalvular structures.

18. The method of claim 5 wherein the contact between said scaffold or valve support device and said valve leaflets is such as to generate a substantial seal between said scaffold or valve support device and said valve leaflets.

19. The method of claim 5 wherein the coupling of said scaffold or valve support device to said valve leaflets or subvalvular structures includes incrementally advancing said scaffold or valve support device relative to valve leaflets.

20. The method of claim 5 wherein said prosthetic or bio-prosthetic valve and said scaffold or valve support device are attached to the patient solely at said valve leaflets or subvalvular structures.

21. The method of claim 5 wherein said prosthetic or bio-prosthetic valve and said scaffold or valve support device are attached to the patient solely at said valve leaflets or subvalvular structures and to a cardiovascular wall via a plurality of elongate suspension elements.

22. The method of claim 5 wherein

the inserting of said scaffold or valve support device inside the patient includes inserting said scaffold or valve support device inside the patient through a catheter, said scaffold or valve support device being connected to a multiplicity of tethers;

and

the attaching of said scaffold of valve support to the patient includes;

manipulating said tethers or suspension elements to move said scaffold or valve support device into a desired position in the heart chamber or vessel;

guiding a plurality of fixation devices or fastener elements over or along said tethers into respective positions about a margin of said scaffold or valve support device;

deploying said fixation devices or fastener elements into a heart chamber or vessel wall to attach said scaffold or valve support device to the heart chamber or vessel wall;

after deployment of said fixation devices or fastener elements, removing said tethers from the patient; and

after the inserting of said scaffold or valve support device inside the patient, seating a prosthetic or bio-prosthetic valve in an orifice of said scaffold or valve support device.

23. The method of claim 22 wherein the inserting of said scaffold or valve support device includes disposing said scaffold or valve support device inside an atrium or ventricle of the patient'"'"'s heart, or a vessel adjacent to a valve, atrium, or ventricle, further comprising attaching a valve leaflet to said scaffold or valve support device or to said prosthetic or bio-prosthetic valve.

24. The method of claim 23 wherein said valve leaflet is part of a natural valve, the attaching of said valve leaflet or subvalvular structure, including inserting a capture device though said natural valve and, upon a closure of said natural valve, operating said capture device to catch and entrain said valve leaflet or subvalvular structure.

25. The method of claim 24 wherein the inserting of said capture device and the operating of said capture device includes expanding said capture device from a closed of collapsed insertion configuration to an expanded deployment configuration.

26. The method of claim 22 wherein said fixation devices or fastener elements are slidably supported or otherwise guided on or by said tethers or suspension elements, the guiding of said fixation devices or fastener elements including sliding same along respective ones of said tethers or suspension elements.

27. The method of claim 22 wherein said fixation devices or fastener elements are separably attached to respective ones of said tethers, further comprising separating said fixation devices or fastener elements from said tethers prior to removal of said tethers or suspension elements from the patient.

7. The method of said 6 wherein the attaching of said ends of said one or more tensile coupling elements includes manipulating one or more tethers or elongate positioning members to position said ends of said one or more tensile coupling elements relative to said heart or cardio-vascular wall.

28. An implantable device for use in valve placement in a subject, the device comprising:

a main body member defining an orifice for receiving or seating a prosthetic or bio-prosthetic valve; and

at least one fastener connected at least indirectly to said main body member for attaching said annular member to leaflets of a native valve.

29. The device of claim 28 wherein said at least one fastener includes one or more tensile coupling elements connected to said main body member for attaching same to the leaflets of said native valve, each said coupling element having a distal end with a hook, clip, barb, or other entrainment component for puncturing, capturing, or otherwise attaching to a valve leaflet or subvalvular structure of a native valve, said coupling components being disposed at intervals around a circumference of said orifice, said coupling elements being configurable to attach said main body member to the valve leaflets of said native valve so that said main body member is in fluid-tight contact with said valve leaflets and substantially fixedly attached thereto, further comprising a system of tether elements removably connected to said main body member for manipulating, positioning, and fixating of said main body member to the native valve.

30. The device of claim 29, further comprising at least one leakage-control element for closing a gap between adjacent ones of said valve leaflets, thereby at least reducing peri-valvular leakage, if necessary.

31. The device of claim 30 wherein said at least one leakage-control element is taken from the group consisting of (a) a flexible expandable member mounted to said main body member and an inflation tube connected to said expandable member for delivering a fluid thereto and (b) an approximation clip.

32. The device of claim 29 wherein said coupling elements are distal end portions of respective elongate tensile members having proximal end portions removably coupled to said distal end portions.

33. The device of claim 32, wherein said tether elements are in the form of elongate tubular members or sleeves each surrounding a respective one of said proximal end portions and in operative or effective engagement at a distal end with said main body member for pushing said main body member in a distal direction relative to said distal end portions of said tensile members, whereby said main body member is movable into engagement with the valve leaflets of said native valve.

34. The device of claim 29, further comprising a plurality of flexible elongate suspension elements connected to said main body member at intervals along a circumference thereof for attaching said main body member to a cardio-vascular wall proximate to said native valve.

35. The device of claim 34, wherein said tether elements are primary tether elements, further comprising a plurality of secondary tether elements extending to distal or free ends of said suspension elements for positioning said distal or free ends and fixing said distal or free ends to a cardio-vascular wall proximate to said native valve.

36. The device of claim 35 wherein:

said secondary tether elements can each be used to deliver a fastener which contains an orifice allowing the fastener to be advanced over or around the respective one of said secondary tether elements; and

each said secondary tether element being provided with a surrounding sleeve, or other advanceable component, slidably movable relative to the respective secondary tether element for advancing the respective said fastener,

distal ends of said secondary tether elements being removably attached to said distal or free ends of said suspension elements.

37. The device of claim 29 wherein said coupling elements are movably attached to said main body member initially for motion alternately in a distal direction and a proximal direction relative to said main body member.

38. The device of claim 37 wherein said coupling elements and said main body member are provided with cooperating ratchet components for preventing the hooks, barbs, or other entrainment components at the distal ends of said coupling elements from moving away from said main body member once said main body member is advanced a predetermined distance over said coupling elements towards the hooks, barbs, or other entrainment components, whereby said main body member is locked into position and cannot be separated from said valve leaflets upon engagement of said main body member with the valve leaflets.

39. The device of claim 37 wherein said tether elements are tubular and coaxially surround proximal end portions of said coupling elements, said tether elements being incrementally advanceable in concert with a proximally directed retraction force exertable on said coupling elements, to induce said main body member and captured native valve leaflets to move towards and into contact with each other.

40. The device of claim 28 wherein said main body member has an outer margin, further comprising:

a plurality of tethers or support members each attached at distal or free ends to said margin, said tethers or support members being spaced from one another about said margin; and

a plurality of fixation devices or fastener elements spaced from one another about said margin and associated with respective ones of said tethers or support members, said fixation devices or fastener elements being configured for at least partial insertion into organic tissue to attach said margin of said main body to a heart chamber or vessel wall.

41. The device of claim 40 wherein said fixation devices or fastener elements are each provided with at least one prong and a cap or head, said prong extending from said cap or head, said cap of head being connected to the respective one of said tethers or support members.

42. The device of claim 41 wherein said fixation devices or fastener elements each include at least two prongs or legs extending from the respective cap or head.

43. The device of claim 42 wherein said prongs or legs are helical.

44. The device of claim 41 wherein said fixation devices or fastener elements are movable over or along said respective ones of said tethers or support members into respective positions about said margin.

45. The device of claim 41 wherein said fixation devices or fastener elements are removably attached to said respective ones of said tethers or support members.

46. The device of claim 40 wherein said cap or head is provided with an orifice traversed by the respective one of said tethers or support members.

47. The device of claim 40 wherein said fixation devices or fastener elements are movable over or along said respective ones of said tethers or support members into respective positions about said margin.

48. The device of claim 40 wherein said fixation devices or fastener elements are removably attached to said respective ones of said tethers or support members.

49. The device of claim 40 wherein said respective ones of said tethers or support members are provided with sleeves engageable with the respective ones of said fixation devices or fastener elements for pushing same into organic tissue of a patient.

50. The device of claim 40 wherein said fixation devices or fastener elements each include a double helix element for penetrating a heart or blood vessel wall, said fixation devices or fastener elements each including a cap or head element configured for straddling a portion of said body member.

51. The device of claim 40 wherein said fixation devices or fastener elements are each provided with an orifice or lumen traversed by the respective one of said tethers or support members, whereby said fixation devices or fastener elements are slidable on said respective ones of said tethers or support members to come into contact with the heart or blood vessel wall at said margin.

52. The device of claim 40 wherein said fixation devices or fastener elements each include a catch element taken from the group consisting of a pin and a spring-loaded barb, for inhibiting unintended dislodgement of said fixation devices or fastener elements from said heart chamber or vessel wall.