Valvuloplasty devices and methods

• US 20050090846A1
• Filed: 05/27/2004
• Published: 04/28/2005
• Est. Priority Date: 07/18/2003
• Status: Active Grant

• Current Assignee: InterValve Medical, Inc.
• Original Assignee: InterValve, Inc. (Venus Medtech (Hangzhou), Inc.)
• Inventors: Brucker, Gregory G., Schwartz, Robert S., Van Tassel, Robert A., Greenhalgh, Skott E., Pedersen, Wesley
• Granted Patent: US 7,618,432 B2
• Time in Patent Office: Days
• US Class Current: 606/159
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• CPC Class Codes: A61B 17/3207 Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions A61B17/32037 takes precedence; endoscopic cutting instruments A61B17/320016
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/22051 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation A61B2017/22048, A61B2017/3486 take precedence
• CPC Class Codes: A61B 2017/22061 for spreading elements apart
• CPC Class Codes: A61B 2017/22098 Decalcification of valves
• CPC Class Codes: A61F 2/013 Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61M 2025/1059 having different inflatable sections mainly depending on the response to the inflation pressure, e.g. due to different material properties with different compartments A61M2025/1072
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/104 used for angioplasty
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

The present invention provides an aortic valvuloplasty catheter which, in one preferred embodiment, has a tapered distal balloon segment that anchors within the left ventricle outflow track of the patient'"'"'s heart and a rounded proximal segment which conforms to the aortic sinuses forcing the valve leaflets open. In addition, this embodiment of the valvuloplasty catheter includes a fiber-based balloon membrane, a distal pigtail end hole catheter tip, and a catheter sheath.

Claims

1. A device for performing valvuloplasty comprising:

a catheter having a lumen for transferring a media therethrough;

a first expandable member disposed towards a distal end of said catheter;

said expandable member in fluid communication with said lumen; and

,

said first expandable member having at least a first portion sized and shaped to be expandable to a profile substantially matching a profile of aortic root sinuses of an aorta connected to a heart.

2. The device of claim 1, wherein said first expandable member further includes a second portion located distal to said first portion, said second portion being sized and shaped to expand to a profile substantially matching a profile of a left ventricular outflow tract of said heart, and wherein said second portion expands at a first media pressure, and said first portion expands at a second media pressure.

3. The device of claim 2, wherein said first expandable member is sized and shaped such that said first media pressure is lower than said second media pressure such that said second portion expands prior to said first portion.

4. The device of claim 1, wherein said first expandable member is comprised of a variably compliant material so as to ensure expansion of said first portion into said profile substantially matching a profile of said aortic root sinuses.

5. The device of claim 1, wherein said catheter includes radiopaque markers.

6. The device of claim 1, wherein said lumen includes a port opening within said first expandable member.

7. The device of claim 1, wherein said catheter includes a screen deployable proximal to said first expandable member.

8. The device of claim 1 wherein said catheter includes a second expandable member disposed distal to said first expandable member, said second expandable member being sized and shaped to expand into a profile that substantially matches a profile of a left ventricular outflow tract of said heart.

9. The device of claim 1, wherein a perfusion passageway is disposed within said first expandable member.

10. The device of claim 1, wherein said expandable member includes axially aligned perfusion grooves.

11. The device according to claim 9, wherein said perfusion passageway extends through a longitudinal length of said first expandable member.

12. The device according to claim 11, wherein said perfusion channel includes a valve to control perfusion through said perfusion channel.

13. The device according to claim 9, wherein said perfusion passageway is comprised of at least one channel disposed at a side of said first expandable member.

14. The device according to claim 13, wherein said perfusion passageway is comprised of two channels disposed at opposite sides of said first expandable member.

15. The device according to claim 8, wherein said first expandable member includes at least one perfusion channel.

16. The device according to claim 15, wherein said at least one perfusion channel is comprised of two walls of said first expandable member spanned by a membrane connecting said two walls.

17. The device according to claim 9, wherein said perfusion passageway extends off-axis through said first expandable member.

18. The device according to claim 17, wherein said perfusion passageway includes an open channel disposed in a second portion of said expandable member, said second portion being distal to said at least a first portion.

19. The device according to claim 18, wherein said perfusion passageway includes a tubular channel above said open channel.

20. A method of performing aortic valvuloplasty comprising:

providing a catheter having an expandable member;

advancing said catheter towards an aortic valve;

securing said catheter in place; and

,

urging leaflets of said aortic valve into an open state by expanding at least a first portion of said expandable member to a profile that substantially matches a profile of the aortic root sinuses of an aorta.

21. A method as set forth in claim 20, wherein securing said catheter in place includes expanding at least a second portion of said expandable member against the walls of a left ventricular outflow tract associated with said aortic valve.

22. A method as set forth in claim 20, wherein said providing of a catheter includes providing a catheter having an expandable member that also includes a second portion, and wherein said securing of said catheter includes expanding said second portion against the walls of a left ventricular outflow tract associated with said aortic valve.

23. A method as set forth in claim 22, wherein the expanding of said first portion occurs after the expanding said second portion.

24. A method as set forth in claim 20, further comprising, allowing perfusion of blood past said expandable member during and after the securing of said catheter in place.

25. A method as set forth in claim 20, further comprising measuring a pressure proximal and distal to said aortic valve.

26. A method as set forth in claim 20, further comprising depositing an anti-restenosis agent in a region of said aortic valve.

27. The method according to claim 20, further comprising:

providing a sheath movable over said catheter such that movement of said sheath controls exposure of said expandable member; and

,

stabilizing said expandable member with said sheath after expanding said expandable member.

28. A device for treating a heart valve comprising:

a sheath;

a ring;

said ring being movable between a compressed state within said sheath and an expanded state outside of said sheath;

said ring being sized to receive at least a portion of each leaflet of said heart valve;

an expandable member movable between a first position within said sheath and a second position outside of said sheath and within said ring; and

said expandable member being sized and shaped to pinch said leaflets against said ring when said expandable member is in an expanded state.

29. The device according to claim 28, wherein said ring and said expandable member are sized and shaped such that hinge points are created on said leaflets when said expandable member pinches said leaflets against said ring.

30. The device according to claim 28, wherein said expandable member is a balloon.

31. The device according to claim 28, further comprising at least one additional ring;

said ring being interchangeable with said ring;

said additional ring being of a different size than said ring.

32. The device according to claim 28, wherein said ring is attached to a control rod movably disposed with said sheath.

33. A method of treating of heart valve comprising:

identifying a diseased heart valve having calcified leaflets placing a ring member against said leaflets; and

,

pinching said leaflets against said ring member so as to create a hinge region on at least one leaflet removing said ring member.

34. The method as set forth in claim 33, wherein said pinching includes introducing an expandable member into said ring such that said leaflets are captured between said ring and said expandable member;

and expanding said expandable member.

35. The method as set forth in claim 33, further comprising placing a second ring against said leaflets and pinching said leaflets against said second ring so as to form multiple hinge regions on said leaflets.

36. A device for treating a heart valve comprising:

a sheath;

a catheter movably disposed within said sheath;

an expandable member disposed towards a distal end of said catheter;

a plurality of wires disposed adjacent said expandable member, said wires extending substantially the length of said expandable member; and

,

said wires contacting said heart valve when said expandable member is in an expanded state.

37. The device according to claim 36, wherein said plurality of wires are fixed at a distal end of said catheter and are movable relative to said catheter at a proximal end.

38. The device according to claim 36, wherein said plurality of wires comprises three wires evenly spaced from each other around said expandable member.

39. The device according to claim 36, wherein said expandable member is a balloon member.

40. A method of treating a heart valve comprising:

identifying a diseased valve having stenosis;

delivering an expandable member to said diseased valve;

expanding said expandable member against leaflets of said stenosed valve; and

,

substantially preventing slippage of said expandable member by urging a plurality of wires against said diseased valve during the expanding of said expandable member.

41. A method as set forth in claim 40, wherein said urging of said plurality of wires includes urging there wires equally spaced around the circumference of said expandable member.

42. A method as set forth in claim 40, wherein said expanding of said expandable member includes expanding a balloon member.

43. A method as set forth in claim 40, further comprising, urging said plurality of wires against said leaflets such that each of said wires create a focal point of force concentration against said leaflets.

44. A method as set forth in claim 43, wherein said urging of said plurality of wires against said leaflets introduces greater flexibility into said leaflets.

45. A method as set forth in claim 43, wherein said urging of said plurality of wires against said leaflets causes separation of at least one point of commissural fusion of said leaflets.

46. A device for treating a heart valve comprising:

a tube;

a first expandable member disposed toward a distal end of said tube;

a second expandable member disposed toward a distal end of said tube and being laterally adjacent said first expandable member;

a first inflation media port disposed within said tube and communicating with said first expandable member; and

,

a second inflation media port disposed within said tube and communicating with said second expandable member.

47. A device according to claim 46, wherein said first and second expandable members collectively form a first portion that substantially conforms to the shape of a left ventricular outflow tract of a heart when said first and second expandable members are each in an expanded condition.

48. A method of treating a heart valve comprising:

identifying a diseased valve having calcified leaflets;

interposing an expandable member against said leaflets;

radially expanding a first side of said expandable member; and

,

radially expanding a second side of said expandable member in substantially the same longitudinal region as the radially expanded first side of said expandable member.

49. A method according to claim 48, further comprising expanding an upper region of said expandable member following radially expanding both the first and second side of said expandable member.

50. A method according to claim 49, wherein the expanding of said upper region includes expanding said upper region so that it substantially conforms to a profile of aortic root sinuses of an aorta proximal to said heart valve.

51. A device for performing valvuloplasty in an aorta comprising:

a catheter having a lumen for transferring a media therethrough;

a first expandable member disposed towards a distal end of said catheter;

said expandable member in fluid communication with said lumen; and

said first expandable member having a first portion sized and shaped to be expandable to a conic profile having a section that substantially presses against an area immediately distal to an aortic valve when said first expandable member is in its expanded state.

52. A device according to claim 51, wherein said first expandable member includes a second portion disposed proximal to said first portion;

said second portion sized and shaped so as to push leaflets of said aortic valve towards an aortic wall when said second portion is in an expanded state.

53. A device according to claim 52, wherein said second portion is sized and shaped so as to push leaflets into the aortic root sinuses of said aorta.

54. A device according to claim 52, wherein said expandable member is a balloon.

55. A device according to claim 54, wherein said expandable member is a variably compliant balloon such that expansion of said first portion occurs before expansion of said second portion.

56. A method of treating a heart valve comprising:

identifying a target heart valve having diseased leaflets;

delivering an expandable member at said diseased leaflets; and

,

engaging a lower conical portion of said expandable member against an underside of said leaflets so as to thereby secure said expandable member in place.

57. A method according to claim 56, further comprising expanding a higher portion of said expandable member against said leaflets and thereby pushing said leaflets against a wall of said aorta.

58. A method according to claim 57, wherein the expanding of said higher portion includes pushing said leaflets into the aortic root sinuses of said aorta.

59. A method according to claim 57, wherein said engaging of said lower conical portion and said expanding of a higher portion leads to treatment of said heart valve.

60. A device for performing valvuloplasty in an aorta comprising:

a sheath;

a catheter movably disposed within said sheath, said catheter having a lumen for transferring a media therethrough;

at least one arm member sized and shaped to deploy from said sheath and engage an aortic sinus wall; and

,

an expandable member attached to said catheter;

said expandable member being in fluid communication with said lumen and positioned to expand against said at least one arm member.

61. A device according to claim 60, wherein said device includes three arm members and a distal end of each arm member sized and shaped to contact said aortic sinus wall substantially at a junction of said aortic sinus wall and leaflets of said aorta.

62. A device according to claim 60, wherein said expandable member is a balloon.

63. A device according to claim 60, wherein said at least one arm member is shaped into a petal-like shape.

64. A device according to claim 60, wherein at least one stress risers is disposed on said at least one arm member.

65. A method of treating a valve comprising:

identifying a valve having diseased leaflets;

delivering at least one arm member to contact an aortic sinus wall at the junction of said wall with at least one of said diseased leaflets and thereby stabilize said at least one arm member; and

,

moving said leaflets outwardly so as to contact said arm members.

66. A method according to claim 65, wherein said delivering at least one arm member includes delivering at least one petal shaped arm member.

67. A method according to claim 66, wherein said delivering at least one petal shaped arm member includes delivering three petal shaped arm members.

68. A method according to claim 65, wherein the moving of said leaflets outwardly includes delivering an expandable member to said leaflets and expanding said leaflets against said petal shaped arm members.

69. A method according to claim 65, wherein the moving of said leaflets outwardly includes moving said leaflets against stress risers disposed on said leaflets.

70. A device for treating a heart valve comprising:

a catheter having a lumen;

a mesh anchoring disk disposed towards a distal region of said catheter;

an expandable member disposed on said catheter proximal to said anchoring disk; and

,

said expandable member sized and shaped to open said valve when said expandable member is in an expanded state.

71. A device according to claim 70, wherein said mesh anchoring disk is self expanding.

72. A device according to claim 70, wherein said mesh anchoring disk is movable between a compressed state and an expanded state.

73. A device according to claim 72, wherein said mesh anchoring disk extends longitudinally along said catheter when in said compressed state.

74. A device according to claim 70, wherein said mesh anchoring disk is comprised of a plurality of semi-rigid, elongated elements.

75. A method of treating a heart valve comprising:

identifying a diseased valve;

delivering an expandable member to said diseased valve;

deploying a mesh anchoring disk such that a periphery of said disk engages walls in a region of said diseased valve and thereby secures said expandable member in place in said valve; and

,

expanding said expandable member to open said diseased valve.

76. A method according to claim 75, wherein the deploying of said mesh anchoring disk includes allowing said mesh anchoring disk to self expand.

77. A method according to claim 75, wherein the deploying of said mesh anchoring disk includes actively expanding said mesh anchoring disk.

78. A method according to claim 75, further comprising allowing blood to perfuse through said mesh after deployment of said mesh anchoring disk.

79. A method according to claim 75, further comprising delivering a prosthetic valve with said mesh anchoring disk.

80. A method according to claim 79, further comprising delivering a prosthetic valve having drug eluting properties.

81. A device for delivering a drug to a heart valve comprising:

a sheath;

a ring member movable within said sheath;

an in situ treatment mechanism disposed on said ring member;

said ring member being detachable from said device; and

,

said ring member being sized and shaped for placement in a left ventricular outflow tract of an aorta.

82. The device according to claim 81, wherein said in situ treatment mechanism includes a decalcification agent.

83. The device according to claim 81, wherein said in situ treatment mechanism includes an anti-fibrotic agent.

84. The device according to claim 81, wherein said in situ treatment mechanism includes an anti-restenotic agent.

85. The device according to claim 81, wherein said in situ treatment mechanism includes an agent to stabilize a stenosis of said heart valve.

86. The device according to claim 81, wherein said in situ treatment mechanism includes an agent to reverse a stenosis of said heart valve.

87. The device according to claim 81, wherein said in situ treatment mechanism includes a plurality of drug eluting fingers disposed around said ring member, said fingers extending into contact with leaflets of a valve.

88. The device according to claim 81, wherein said in situ treatment mechanism includes a plurality of drug eluting pods disposed on said ring member.

89. The device according to claim 88, wherein said drug eluting pods are T-shaped.

90. The device according to claim 88, wherein said drug eluting pods are L-shaped.

91. A device for treating a heart valve comprising:

a post;

an in situ treatment agent disposed on said post;

a retention barb disposed on said post; and

,

said post sized and shaped for placement in a leaflet of said heart valve.

92. A method of treating a diseased valve comprising:

performing a valvuloplasty on said diseased valve; and

placing an implant in the region of said diseased valve, said implant having an in situ treatment agent disposed thereon.

93. A method of performing aortic valvuloplasty comprising:

providing a catheter having an expandable member;

advancing said catheter towards an aortic valve;

securing said catheter in place; and

,

urging leaflets of said aortic valve into an open state by expanding at least a first portion of said expandable member; and

,

applying external beam radiation therapy to said aortic valve.

94. A method according to claim 93, wherein applying external beam radiation therapy includes applying a total dosage of around 12-18 Gy in fractions over a period of about 3 to 5 days.

95. A method according to claim 93, wherein applying external beam radiation therapy includes applying said therapy in a confined region of a thoracic space.