Device and method providing arterial blood flow for perfusion of ischemic myocardium

• US 20030181843A1
• Filed: 09/06/2002
• Published: 09/25/2003
• Est. Priority Date: 06/11/2002
• Status: Abandoned Application

• Current Assignee: Scout Medical Technologies LLC (Mpm Capital LLC)
• Original Assignee: Scout Medical Technologies LLC (Mpm Capital LLC)
• Inventors: Bibber, Richard Van, Alferness, Clifton A., Wolf, Scott, Adams, John M.
• Application Number:
  US10/236,386
• Publication Number:
  US 20030181843A1
• Time in Patent Office: Days
• US Class Current: 604/8
• 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 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 17/115 Staplers for performing anastomosis in a single operation
• CPC Class Codes: A61B 17/1155 Circular staplers comprising a plurality of staples
• 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 2017/00252 for by-pass connections, i.e. connections from heart chamber to blood vessel or from blood vessel to blood vessel
• CPC Class Codes: A61B 2017/00663 the implement being a suture
• CPC Class Codes: A61B 2017/0474 Knot pushers
• CPC Class Codes: A61B 2017/1135 End-to-side connections, e.g. T- or Y-connections Y-shaped blood vessel prostheses A61F2002/065

Abstract

The present invention generally relates to methods and apparatus for use in endovascular and intraoperative procedures providing arterial blood flow for perfusion of ischemic myocardium. Aspects of the present invention provide a conduit between a non-coronary sinus of the aorta and a coronary vein. The conduit traverses a portion of the right atrium and the coronary sinus, and is located entirely within the heart and aorta. Arterial blood flows from the aorta through the conduit and into the coronary venous circulation towards the ischemic region of the heart. All procedures described herein may be performed endovascularly, and further may be performed while the patient'"'"'s heart is beating.

Claims

1. A device that provides arterial blood flow from the aorta to a vascular structure for perfusion of cardiac tissue, the device comprising:

a connector arranged to receive arterial blood flow from the aorta;

an arterial blood conduit in fluid communication with the connector and the vascular structure, the conduit arranged for placement within a heart chamber and the vascular structure; and

a connector arranged to couple the conduit with the vascular structure.

2. The device of claim 1, wherein the device is arranged for endovascular implantation.

3. The device of claim 1, wherein the device is arranged for endovascular implantation in a beating heart.

4. A device that provides arterial blood flow from aorta to coronary venous system for venous retroperfusion of myocardium, the device comprising:

an aorta-right atrium traversing connector arranged to receive arterial blood flow from the aorta;

an arterial blood conduit in fluid communication with the traversing connector and a portion of the venous system, the conduit arranged for placement within the right atrium and the coronary sinus; and

a venous connector arranged to couple the conduit with the coronary venous system.

5. The device of claim 4, wherein the aorta-right atrium traversing connector comprises an inlet member arranged for receiving arterial blood flow from the aorta and for traversing a first aperture in an aortic wall and a second aperture in a right atrium wall, and having a channel providing fluid communication.

6. The device of claim 4, wherein the arterial blood conduit comprises a tubular member having a first end, a second end, and a lumen providing fluid communication between the ends, the tubular material comprising a flexible material.

7. The device of claim 4, wherein the arterial blood conduit comprises a member having a first end adapted to be coupled to the aorta-right atrium traversing connector, a second end adapted to be coupled to the venous connector, an intermediate portion located between the ends, a lumen providing fluid communication between the ends, a first region near the first end adapted to be placed in the right atrium and a second region near the second end adapted to be placed into a portion of the venous system, the member comprising a flexible material.

8. The device of claim 7, wherein the intermediate portion of conduit includes a self-sealing diaphragm.

9. The device of claim 4, wherein the arterial blood conduit includes a biocompatible material that comprises at least one from the group consisting of polyvinyl chloride, polyethylene, polytetrafluoroethylene (PTFE), and ePTFE.

10. The device of claim 4, wherein the arterial blood conduit includes a vascular structure.

11. The device of claim 10, wherein the vascular structure includes an autologous vein.

12. The device of claim 4, wherein the venous connector comprises:

a radially expandable elongated structure that includes a portion arranged for annular enlargement and configured for disposition around the inside of a lumen of the coronary venous system, and which, when annularly enlarged within the lumen, engages the conduit with the vascular lumen.

13. The device of claim 4, wherein the device includes arrangement for endovascular implantation.

14. The device of claim 4, wherein the device includes arrangement for endovascular implantation in a beating heart.

15. An aorta-right atrium traversing connector comprising an inlet member arranged for receiving arterial blood flow from the aorta and for traversing a first aperture in an aortic wall and a second aperture in a right atrium wall, and having a channel providing fluid communication.

16. The aorta-right atrium traversing connector of claim 15, wherein the first aperture occurs at a point proximate to a non-coronary aortic sinus.

17. The aorta-right atrium traversing connector of claim 15, wherein the inlet member includes arrangement for coupling with a conduit arranged to carry the arterial blood flow.

18. The aorta-right atrium traversing connector of claim 17, wherein the inlet member includes an annularly enlargeable structure that, when annularly enlarged within a portion of a conduit arranged to carry the arterial blood flow, couples the inlet member to the conduit.

19. The aorta-right atrium traversing connector of claim 15, wherein the inlet member includes arrangement to move from a first configuration for endovascular placement in the first and second apertures to a second configuration of implantation in the first and second apertures.

20. The aorta-right atrium traversing connector of claim 15, wherein a portion of the inlet member includes arrangement for self-annular expansion after deployment from a sheath.

21. The aorta-right atrium traversing connector of claim 15, wherein a portion of the inlet member includes arrangement for annular enlargement by expansion of an inflatable expandable structure positioned within the portion of the inlet member.

22. The aorta-right atrium traversing connector of claim 15, wherein the inlet member includes at least one element that extends radially outward and arranged to engage an interior portion of the aortic wall.

23. The aorta-right atrium traversing connector of claim 15, wherein the channel comprises a portion of arterial blood conduit arranged around a portion of the inlet member.

24. The aorta-right atrium traversing connector of claim 15, wherein the connector includes arrangement for endovascular implantation.

25. The aorta-right atrium traversing connector of claim 15, wherein the connector includes arrangement for endovascular implantation in a beating heart.

26. An aorta-right atrium traversing connector, the traversing connector comprising:

an inlet member arranged for receiving arterial blood flow from the aorta and for traversing a first aperture in an aortic wall and a second aperture in a right atrium wall, and having a channel providing fluid communication; and

a positioning member arranged to maintain the inlet member in a selected position.

27. The aorta-right atrium traversing connector of claim 26, wherein the inlet member includes arrangement for engaging the aorta.

28. The aorta-right atrium traversing connector of claim 26, wherein the positioning member includes an element for engaging an interior wall of the right atrium.

29. The aorta-right atrium traversing connector of claim 26, wherein the positioning member includes arrangement for engaging the right atrium and the inlet member.

30. The aorta-right atrium traversing connector of claim 26, wherein the positioning member includes at least one element extending radially outward, and arranged to engage an interior portion of the right-atrial wall and position the inlet member relative to the right-atrial wall.

31. The aorta-right atrium traversing connector of claim 30, wherein the radially extending element includes arrangement for moving from a first configuration for endovascular placement to a second configuration for engagement.

32. The aorta-right atrium traversing connector of claim 26, wherein a portion of the positioning member includes arrangement to resist annular enlargement.

33. The aorta-right atrium traversing connector of claim 26, wherein the inlet member further comprises an element for engaging an aortic interior wall, and the positioning member includes an element for engaging a right-atrial interior wall, and when a portion of the positioning member engages a portion of the inlet member, the inlet member engaging element and the position member engaging element are arranged to cooperatively compress tissue radial of the apertures between them.

34. The aorta-right atrium traversing connector of claim 33, wherein the compression limits blood leakage from at least one of the aorta and the right atrium.

35. An assembly of catheters having magnetically alignable lumens, the assembly comprising:

a first catheter arranged for placement into a cavity of a body structure and having a first distal tip, a first magnetic member carried proximate to the first distal tip, and a first lumen having a distal entrance;

a second catheter arranged for placement into a cavity of another body structure and having a second distal tip, a second magnetic member carried proximate to the second distal tip, and a second lumen having a distal entrance, the magnetic member of one catheter being arranged to attract and align with the magnetic member of the other catheter, such that, when the magnetic members align, the distal entrances of the first and second lumens also align.

36. The assembly of claim 35, wherein at least one cavity is a lumen of a vascular structure.

37. An assembly of catheters having alignable lumens, the assembly comprising:

a first catheter arranged for placement into a cavity of a body structure and having a first distal tip, a first alignment member carried proximate to the first distal tip, and a first lumen having a distal entrance; and

a second catheter arranged for placement into a cavity of another body structure and having a second distal tip, a second alignment member carried proximate to the second distal tip, and a second lumen having a distal entrance, the alignment member of one catheter being arranged to align with the alignment member of the other catheter, such that, when the alignment members align, the distal entrances of the first and second lumens also align.

38. The assembly of claim 37 wherein one alignment member is an electrical signal source and another alignment member is an electrical signal sensor.

39. The assembly of claim 37, wherein one alignment member is an ultrasound source and another alignment member is an ultrasound sensor.

40. The assembly of claim 37, wherein one alignment member is a light source and another alignment member is a light sensor.

41. An assembly for use in creating a guidewire pathway between two body structures, the assembly comprising:

a first catheter arranged for placement into a cavity of a body structure and having a first distal tip, a first alignment member carried proximate to the first distal tip, and a first lumen having a distal entrance; and

a second catheter arranged for placement into a cavity of another body structure and having a second distal tip, a second alignment member carried proximate to the second distal tip, and a second lumen having a distal entrance, the alignment member of one catheter being arranged to align with the alignment member of the other catheter, such that, when the alignment members align, the distal entrances of the first and second lumens also align; and

a guidewire deployable from one lumen and receivable by the other lumen.

42. The assembly of claim 41, wherein at least one cavity includes a lumen of a vascular structure.

43. The assembly of claim 41, wherein one cavity includes a cardiac chamber.

44. The assembly of claim 41, wherein one catheter includes arrangement for transvascular placement in an arterial structure.

45. The assembly of claim 41, wherein one catheter includes arrangement for transvascular placement in a venous structure.

46. The assembly of claim 41, wherein one catheter includes arrangement for transvascular placement in an arterial structure and another catheter includes arrangement for transvascular placement in a venous structure.

47. The assembly of claim 41, wherein both alignment members are a magnetic, and are arranged to attract and align with each other.

48. The assembly of claim 41 wherein one alignment member is an electrical signal source and another alignment member is an electrical signal sensor.

49. The assembly of claim 41, wherein one alignment member is an ultrasound source and another alignment member is an ultrasound sensor.

50. The assembly of claim 41, wherein one alignment member is a light source and another alignment member is a light sensor.

51. The assembly of claim 41, wherein guidewire further includes a penetrating portion for penetrating tissue lying between the entrances to the lumens.

52. The assembly of claim 51, wherein one catheter further includes an element arranged to snare the penetrating portion.

53. The assembly of claim 51, wherein the penetrating portion includes a penetration aid selected from a group consisting of a thermal heating element, a laser energy emitter, a RF cutting device, and a vibration device.

54. The assembly of claim 51, wherein the penetrating portion includes a hollow needle and the guidewire is arranged for advancement through tissue penetrated by the hollow needle.

55. The assembly of claim 51, wherein the penetrating portion includes arrangement for penetrating between an aorta and a right-atrium.

56. The assembly of claim 41, wherein one distal tip includes a substance viewable with an imaging device.

57. The assembly of claim 41, wherein one catheter further includes an additional lumen arranged to eject a substance viewable with an imaging device.

58. An instrument for forming an aperture between cavities of two proximate body structures and deploying a connector in the aperture, the instrument comprising:

a tubular structure arranged for placement in one of the cavities and having a sheath for deploying the connector;

a tissue-cutting member arranged to form the aperture in tissue between the cavities;

a guidewire following member; and

a sheath arranged for deploying the connector in the aperture.

59. The instrument of claim 58, further including a cut tissue retention member.

60. The instrument of claim 58, further including a movement control member having an extracorporeal portion and arranged for moving the instrument along a guidewire and.

61. The instrument of claim 60, wherein the movement control member includes a radially expandable structure.

62. The instrument of claim 58, wherein the connector includes arrangement for traversing between lumens of an aorta and a right atrium.

63. The instrument of claim 58, wherein the tissue-cutting member includes a cutting aid selected from a group consisting of a thermal heating element, a laser energy emitter, a RF cutting device, and a vibration device.

64. The instrument of claim 58, wherein the guidewire following member includes arrangement for engaging a guidewire moved in a direction relative to the instrument.

65. The instrument of claim 58, wherein the instrument includes arrangement for endovascular use.

66. The instrument of claim 58, wherein the instrument includes arrangement for endovascular use in a beating heart.

67. An intra-luminal venous connector for fluid coupling a conduit placed in a cardiac vascular lumen to the vascular lumen, the connector comprising an annularly enlargeable structure that, when annularly enlarged within a portion of a conduit arranged to carry arterial blood flow, couples the conduit with the vascular lumen.

68. The venous connector of claim 67, wherein the structure includes arrangement for annular enlargement by a radially expandable structure placed within a portion of the elongated structure.

69. The connector of claim 67, wherein when the structure is annularly enlarged and coupling the conduit with the vascular lumen, blood flow from the conduit into a right atrium is limited.

70. The connector of claim 67, wherein the connector includes arrangement for endovascular implantation.

71. The connector of claim 67, wherein the connector includes arrangement for endovascular implantation in a beating heart.

72. An assembly for use in implanting an aorta-right atrium traversing connector, the assembly comprising:

a guidewire path creation subassembly arranged for creating a guidewire pathway between an aorta and a right atrium, the subassembly including a first catheter having a distal tip arranged for placement into a cavity of a body structure and a lumen, a second catheter having a distal tip arranged for placement into a cavity of a body structure and a lumen, and a guidewire deployable from one catheter lumen and receivable by another catheter lumen and having a tissue penetrating element arranged to create a guidewire pathway by penetrating tissue between the lumens; and

a guidewire guided instrument arranged for creating an aperture in response to the guidewire pathway between the aorta and the right atrium, and deploying a connector in the aperture.

73. The assembly of claim 72, wherein the guidewire guided instrument includes a tubular structure arranged for endovascular placement, a sheath arranged for carrying and deploying the traversing connector, a tissue-cutting element, and a guidewire following member.

74. The assembly of claim 72, wherein the guidewire guided instrument includes a movement control member for moving the instrument along a guidewire and having an extracorporeal portion.

75. The assembly of claim 72, further including a device arranged to provide arterial blood flow from the aorta to coronary venous system for venous retroperfusion of myocardium, the device including:

an aorta-right atrium traversing connector arranged to receive arterial blood flow from the aorta;

an arterial blood conduit in fluid communication with the traversing connector and a portion of the venous system, the conduit arranged for placement within the right atrium and the coronary sinus; and

a venous connector that couples the conduit to the coronary venous system.

76. The assembly of claim 72, wherein the assembly includes arrangement for use in a beating heart.

77. The assembly of claim 72, wherein the assembly includes arrangement for endovascular use.

78. A method of providing venous retroperfusion of myocardium, the method including the steps of:

acquiring arterial blood flow from an aorta;

conveying the arterial blood flow through a right atrium, through a coronary sinus, and into a portion of a coronary venous system; and

discharging the arterial blood flow in a portion of the coronary venous system for venous retroperfusion of a myocardium.

79. The method of claim 78, wherein the arterial blood flow is acquired from the non-coronary aortic sinus.

80. The method of claim 78, wherein the step of acquiring the arterial blood flow includes the further step of directing the blood flow into an arterial blood conduit.

81. The method of claim 78, wherein the step of conveying the arterial blood flow includes the further step of routing an arterial blood conduit from acquisition in the aorta to a point of discharge in the coronary venous system.

82. The method of claim 78, wherein the step of providing the arterial blood flow includes the further step of coupling an arterial blood conduit with a lumen of the coronary venous system.

83. The method of claim 78, wherein the step of discharging arterial blood flow includes normal cardiac arterial blood flow phasing.

84. The method of claim 78, wherein the discharged arterial blood flow includes normal cardiac arterial blood pressure.

85. The method of claim 78, wherein the steps are performed in a beating heart.

86. The method of claim 78, wherein the steps are performed endovascularly.

87. A method of implanting a device that provides arterial blood flow from an aorta to a portion of a coronary venous system for venous retroperfusion of myocardium, the method including the steps of:

placing an arterial catheter in the non-coronary aortic sinus at a position proximate to an aortic wall;

placing a venous catheter in the right atrium at a position proximate to an atrium wall, and in approximate opposition to the arterial catheter;

passing an arterial guidewire between the venous catheter and the arterial catheter, the guidewire passing through both the aortic wall and the atrium wall and having a proximal end;

placing a distal end of a venous guidewire into a lumen of the coronary venous system, the venous guidewire having a proximal end located adjacent to the proximal end of the arterial guidewire;

mounting portions of a lumen of the device moveably over the adjacent proximal ends of the venous guidewire and the arterial guidewire, a first portion being mounted on the arterial guidewire and the second portion being mounted on the venous guidewire;

moving the mounted device along the guidewires into the right atrium;

deploying the aorta-right atrium connector in the pathway and in fluid communication with the aorta; and

deploying the venous connector in the selected portion of the venous system.

88. The method of claim 87, wherein the device includes an arterial blood flow conduit having a first portion with an aorta-right atrium traversing connector arranged to receive arterial blood from the aorta mounted on one end and second portion with a venous connector arranged to couple the conduit into a lumen of the coronary venous system mounted on a second end.

89. A device that provides venous retroperfusion of myocardium, the device comprising:

means for acquiring an arterial blood flow from an aorta;

means for conveying the acquired arterial blood flow through a right atrium and into a coronary sinus; and

means for discharging the arterial blood flow into a portion of a coronary venous system.