METHODS AND DEVICES FOR REPAIR OR REPLACEMENT OF HEART VALVES OR ADJACENT TISSUE WITHOUT THE NEED FOR FULL CARDIOPULMONARY SUPPORT

• US 20140107773A1
• Filed: 04/23/2013
• Published: 04/17/2014
• Est. Priority Date: 10/02/2004
• Status: Abandoned Application

• Current Assignee: Endoheart AG
• Original Assignee: Endoheart AG
• Inventors: Huber, Christoph Hans
• Application Number:
  US13/868,943
• Publication Number:
  US 20140107773A1
• Time in Patent Office: Days
• US Class Current: 623/2.18
• 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

1-45. -45. (canceled)

46. A heart valve having a longitudinal axis, the valve comprising a self-expanding stent that includes a curved tissue-engaging peak that curves away from the longitudinal axis.

47. The valve of claim 46 wherein the self-expanding stent defines:

a first circumference in a first plane perpendicular to the longitudinal axis;

a second circumference in a second plane perpendicular to the longitudinal axis; and

a third circumference in a third plane perpendicular to the longitudinal axis;

wherein;

the second circumference is between the first and third circumferences;

the first and third circumferences are greater than the second circumference; and

the tissue-engaging peak is part of the third circumference.

48. The valve of claim 47 wherein the first, second and third circumferences, together, are configured to conform to a native valve rim to secure the valve against dislodgement from the native valve rim.

49. The valve of claim 47 further comprising a securement element that is supported by the self-expanding stent, the securement element providing security against dislodgement, from heart tissue, of the self-expanding stent.

50. The valve of claim 49 wherein the securement element is a hook.

51. The valve of claim 49 wherein the securement element is configured to bite into an aortic rim.

52. The valve of claim 49 wherein the securement element is configured to bite into an aortic wall.

53. The valve of claim 49 wherein the securement element is configured to grasp an aortic rim.

54. The valve of claim 49 wherein the securement element is configured to grasp an aortic wall.

55. The valve of claim 46 wherein the self-expanding stent includes a sinusoidal structure.

56. The valve of claim 46 wherein the self-expanding stent is configured to exert radial expansion forces that are strong enough to secure the valve against dislodgment.

57. The valve of claim 46 wherein the peak is included in a plurality of peaks, the plurality including proximal peaks and distal peaks.

58. The valve of claim 57 wherein the proximal peaks and distal peaks are configured to engage a native valve annulus.

59. The valve of claim 58 wherein the proximal peaks and the distal peaks are pointed or sharpened.

60. The valve of claim 46 wherein the peak is a distal peak and is configured to engage an aortic wall.

61. The valve of claim 46 further comprising a distal mounting ring supported distal to the peak by distal ends of commissure supports, the distal mounting ring corresponding to an aortic wall extending from an aortic sino-tubular junction.

62. The valve of claim 46 further comprising a stent-like support structure supported distal to the peak by distal ends of commissure supports and corresponding to an aortic wall extending from an aortic sino-tubular junction.

63. The valve of claim 62 wherein the stent-like support structure is configured to support a distal end of the valve such that the valve is supported against the aortic wall at a location distal to coronary sinuses.

64. The valve of claim 46 wherein the self-expanding stent includes a bulge that corresponds to a natural curvature below an aortic sino-tubular junction, the bulge providing securement against dislodgement of the valve relative to the curvature.

65. The valve of claim 64 wherein the bulge mimics the natural curvature.

66. The valve of claim 64 further comprising a commissure support that has a portion that is included in the bulge.

67. The valve of claim 46 further comprising valve leaflets, wherein the stent includes a stent frame that includes commissure supports configured to support the valve leaflets.

68. The valve of claim 46 further comprising attachment points designated for attachment to corresponding retraction devices.

69. The valve of claim 68 wherein the attachment points are designated for attachment to corresponding retraction wires.

70. The valve of claim 46 wherein the self-expanding stent is configured to be mechanically attached to a delivery device.

71. The valve of claim 46 wherein the self-expanding stent is compressible.

72. The valve of claim 46 further comprising commissure supports that are configured to support, distal to the peak, valve leaflets.

73. The valve of claim 46 wherein the self-expanding stent comprises a shape-memory material.

74. The valve of claim 46 wherein the peak is a proximal peak and is configured to engage a native valve annulus.

75. The valve of claim 46 wherein the peak is included in a plurality of peaks, the plurality including proximal peaks.

76. The valve of claim 46 wherein the peak is included in a plurality of peaks, the plurality including distal peaks.

77. The valve of claim 47 wherein the second and third circumferences, together, are configured to conform to a native valve rim to secure the valve against dislodgement from the native valve rim.

78. The valve of claim 77 wherein the first circumference is configured to be deployed distal to an aortic sino-tubular junction.

79. The valve of claim 77 wherein the first circumference is configured to be deployed at an aortic sino-tubular junction.

80. The valve of claim 47 wherein the third circumference is configured to conform to a native valve rim to secure the valve against dislodgement from the native valve rim.

81. The valve of claim 80 wherein the first circumference is configured to be deployed distal to an aortic sino-tubular junction.

82. The valve of claim 80 wherein the first circumference is configured to be deployed at an aortic sino-tubular junction.

83. The valve of claim 64 wherein the bulge is configured to conform to the natural curvature.