Methods and devices for repair or replacement of heart valves or adjacent tissue without the need for full cardiopulmonary support

• US 20060074484A1
• Filed: 12/28/2004
• Published: 04/06/2006
• Est. Priority Date: 10/02/2004
• Status: Active Grant

• Current Assignee: Edwards Lifesciences CardiAQ LLC (Edwards Lifesciences Corporation)
• Original Assignee: Endoheart AG
• Inventors: Huber, Christoph Hans
• Granted Patent: US 8,182,530 B2
• Time in Patent Office: Days
• US Class Current: 623/2.110
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 17/22004 using mechanical vibrations, e.g. ultrasonic shock waves A61B17/225 takes precedence
• CPC Class Codes: A61B 17/2202 the ultrasound transducer being inside patient's body at the distal end of the catheter
• CPC Class Codes: A61B 17/320016 Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes A61B10/0233, A61B17/29, A61B17/3207 take precedence
• CPC Class Codes: A61B 17/32053 Punch like cutting instruments, e.g. using a cylindrical or oval knife A61B17/326 takes precedence; trepans A61B17/1695; for use on the cornea A61F9/007
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 17/3423 Access ports, e.g. toroid shape introducers for instruments or hands access sites for liquids A61M39/0247
• CPC Class Codes: A61B 17/3462 with means for changing the diameter or the orientation of the entrance port of the cannula, e.g. for use with different-sized instruments, reduction ports, adapter seals expandable cannulas A61B17/3417
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/00278 Transorgan operations, e.g. transgastric
• CPC Class Codes: A61B 2017/22024 with a part reflecting mechanical vibrations, e.g. for focusing
• CPC Class Codes: A61B 2017/22055 with three or more balloons
• CPC Class Codes: A61B 2017/3425 for internal organs, e.g. heart ports
• CPC Class Codes: A61B 2017/3441 with distal sealing means
• CPC Class Codes: A61B 2017/3488 Fixation to inner organ or inner body tissue
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61F 2/012 Multiple filtering units
• CPC Class Codes: A61F 2/014 : Retrograde blood flow filters, i.e. device inserted against the blood flow direction
• CPC Class Codes: A61F 2/07 : Stent-grafts
• CPC Class Codes: A61F 2/2403 : with pivoting rigid closure members check valves with hinged closure members in general F16K15/03
• 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 2/2433 : using balloon catheter
• CPC Class Codes: A61F 2/848 : having means for fixation to the vessel wall, e.g. barbs
• CPC Class Codes: A61F 2/856 : Single tubular stent with a side portal passage
• CPC Class Codes: A61F 2/89 : the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• CPC Class Codes: A61F 2/90 : characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2002/018 : made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61F 2002/061 : provided with means for allowing access to secondary lumens
• CPC Class Codes: A61F 2002/9534 : for repositioning of stents
• CPC Class Codes: A61F 2210/0014 : using shape memory or superelastic materials, e.g. nitinol
• 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 2230/0006 : circular
• CPC Class Codes: A61F 2230/005 : Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 : V-shaped
• CPC Class Codes: A61F 2230/0069 : cylindrical
• CPC Class Codes: A61F 2230/0078 : hyperboloidal
• CPC Class Codes: A61F 2230/008 : paraboloidal
• CPC Class Codes: A61F 2250/0003 : having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/0039 : differing in diameter
• CPC Class Codes: A61F 2250/0098 : radio-opaque, e.g. radio-opaque markers

Abstract

Methods and systems for endovascular, endocardiac, or endoluminal approaches to a patient'"'"'s heart to perform surgical procedures that may be performed or used without requiring extracorporeal cardiopulmonary bypass. Furthermore, these procedures can be performed through a relatively small number of small incisions. These procedures may illustratively include heart valve implantation, heart valve repair, resection of a diseased heart valve, replacement of a heart valve, repair of a ventricular aneurysm, repair of an arrhythmia, repair of an aortic dissection, etc. Such minimally invasive procedures are preferably performed transapically (i.e., through the heart muscle at its left or right ventricular apex).

Claims

1. A method of operating on a patient comprising:

accessing the patient'"'"'s heart;

installing an access device in a wall of the heart, the access device having means for preventing bleeding through the access device; and

performing a surgical procedure.

2. The method of claim 1 further comprising resecting a native heart valve.

3. The method of claim 1 further comprising implanting a heart valve.

4. The method of claim 1 further comprising repairing an aortic dissection.

5. The method of claim 1 further comprising repairing a heart valve.

6. The method of claim 1 wherein installing the access device in the wall of the heart further comprises installing the access device in a ventricular apex of the heart.

7. A method for implanting a heart valve comprising:

accessing a patient'"'"'s heart;

installing an access device in a wall of the heart, the access device having means for preventing bleeding through the access device;

inserting a valve delivery device through the access device; and

installing the heart valve.

8. The method of claim 7 further comprising resecting a native heart valve.

9. The method of claim 8 wherein the resecting the native heart valve is performed percutaneously and the installing the heart valve is performed transapically.

10. The method of claim 7 wherein the installing the heart valve further comprises radially expanding the heart valve.

11. The method of claim 7 wherein the installing the heart valve further comprises pulling leaflets of a native heart valve downward.

12. A device for implanting a heart valve comprising:

means for radially expanding the heart valve; and

means for supplementing blood flow through the device during the implanting the heart valve.

13. The device of claim 12 further comprising means for pulling leaflets of a native valve downward.

14. The device of claim 12 wherein the radially expanding the heart valve occurs in more than one stage.

15. The device of claim 14 wherein the more than one stage is effectuated by a multi-stage balloon.

16. A method of visualizing a portion of a patient'"'"'s circulatory system comprising:

injecting a transparent oxygen-carrying fluid into the portion of the circulatory system; and

inserting an optical device into the portion of the circulatory system containing the transparent oxygen-carrying fluid.

17. The method of claim 16 further comprising temporarily exchanging all blood of the patient'"'"'s circulatory system with the transparent oxygen-carrying fluid.

18. Instrumentation for accessing a chamber of a patient'"'"'s heart, the heart having a myocardium, the instrumentation comprising:

a catheter having a proximal sealing device for sealing the catheter against a proximal surface of the myocardium; and

means for preventing bleeding through the catheter.

19. The instrumentation of claim 18 further comprising a distal sealing device for sealing the catheter against the distal surface of the myocardium.

20. An implantable heart valve comprising:

a tissue support structure; and

tissue valve leaflets, wherein the tissue valve leaflets are grown inside the tissue support structure by genetic engineering.

21. The heart valve of claim 20 wherein the tissue support structure is a stent.

22. The heart valve of claim 20 wherein the tissue support structure comprises stainless steel.

23. The heart valve of claim 20 wherein the tissue support structure comprises a self-expanding material.

24. The heart valve of claim 23 wherein the self-expanding material is nitinol.

25. A device for inserting more than one guidewire into a patient comprising:

a wire placement device; and

a guidewire attached to the wire placement device, wherein the wire placement device is configured to track an already placed guidewire.

26. The device of claim 25 wherein the guidewire is removably attached to the wire placement device.

27. The device of claim 25 wherein the wire placement device comprises a locking mechanism.

28. A method of breaking down calcification of a heart valve comprising:

inserting a catheter-based ultrasound device into a calcified heart valve; and

concentrating ultrasound radiation on the calcification of the calcified heart valve to break down the calcification.

29. The method of claim 28 further comprising inserting a reflector into the calcified heart valve to magnify the ultrasound radiation.

30. A low-profile heart valve comprising:

at least three leaflets, wherein one side of each leaflet overlaps a neighboring leaflet such that the leaflets open sequentially and close sequentially.

31. A heart valve comprising:

an inner circumference and an outer circumference, wherein the inner circumference is a circumference of an annulus formed by leaflets of the heart valve; and

the outer circumference is a circumference of a fluid-tight diaphragm, wherein the diaphragm fills a space between the inner circumference and the outer circumference.

32. A mitral valve repair device comprising:

a first head defining an operating plane; and

a second head operably attached to the first head and configured to displace a leaflet with respect to the operating plane.

33. The repair device of claim 32 wherein the first head is a U-shaped head.

34. The repair device of claim 32 wherein the first head comprises an attachment mechanism for attaching at least two portions of the leaflet.

35. The repair device of claim 32 further comprising a handle for operating the second head with respect to the first head.

36. A method of repairing an aortic dissection comprising:

accessing a patient'"'"'s heart;

installing an access device in a wall of the heart, the access device having means for preventing bleeding through the access device;

inserting a dissection repair device through the access device; and

repairing the aortic dissection.

37. A device for repairing an aortic dissection comprising:

annularly enlargeable componentry configured to be inserted into a patient'"'"'s aorta; and

means for closing a void created by the aortic dissection.

38. The device of claim 37 wherein the means for closing the void comprise injection needles for injecting a tissue sealant.

39. The device of claim 38 wherein the tissue sealant comprises a biologically compatible glue.

40. The device of claim 38 wherein the tissue sealant comprises mechanical sutures.

41. The device of claim 38 wherein the tissue sealant comprises surgical staples.

42. The device of claim 38 wherein the annularly enlargeable componentry comprises means for supplementing blood flow through the componentry during the repair.

43. A device for resecting a diseased heart valve comprising:

a first set of annularly enlargeable componentry having a first longitudinal axis and a proximal cutting edge;

a second set of annularly enlargeable componentry having a second longitudinal axis and a distal cutting edge;

wherein the device is configured to resect the diseased heart valve when the first set of componentry is enlarged on a distal side of the diseased heart valve and the second set of componentry is enlarged on a proximal side of the diseased heart valve and the sets of componentry are drawn axially together along the longitudinal axes.

44. The device of claim 43 wherein the first longitudinal axis and the second longitudinal axis are coaxial.

45. A method for implanting an endoprosthesis comprising:

accessing a patient'"'"'s heart;

installing an access device in a wall of the heart, the access device having means for preventing bleeding through the access device;

inserting an endoprosthesis delivery device through the access device; and

installing the endoprosthesis.