ENDOVASCULAR SYSTEM FOR ARRESTING THE HEART

• US 20010016725A1
• Filed: 09/25/1998
• Published: 08/23/2001
• Est. Priority Date: 07/16/1991
• Status: Active Grant

• Current Assignee: Edwards Lifesciences LLC (Edwards Lifesciences Corporation)
• Original Assignee: Heartport, Inc. (Johnson & Johnson)
• Inventors: SNOW, DAVID W., ROTH, ALEX T., GIFFORD, HANSON S. III, BOYD, STEPHEN W., DONLON, BRIAN S., PETERS, WILLIAM S., FAN, SYLVIA W., MUELLER, RICHARD J. Jr., CORVI, TIMOTHY C., VALLEY, KIRSTEN L.
• Granted Patent: US 6,913,600 B2
• Time in Patent Office: Days
• US Class Current: 604/509
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/0218 for minimally invasive surgery A61B17/0281, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/0467 Instruments for cutting sutures surgical cutting instruments A61B17/32
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/06061 Holders for needles or sutures, e.g. racks, stands hand-held holding instruments A61B17/0483; holders for articles A61B50/20; racks for syringes or for hypodermic or infusion needles A61M5/008
• CPC Class Codes: A61B 17/2909 Handles
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• 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 2017/0243 for immobilizing local areas of the heart, e.g. while it beats
• CPC Class Codes: A61B 2017/047 having at least one proximally pointing needle located at the distal end of the instrument, e.g. for suturing trocar puncture wounds starting from inside the body
• CPC Class Codes: A61B 2017/0472 Multiple-needled, e.g. double-needled, instruments
• CPC Class Codes: A61B 2017/0474 Knot pushers
• CPC Class Codes: A61B 2017/0475 using sutures having a slip knot
• CPC Class Codes: A61B 2017/2943 Toothed members, e.g. rack and pinion
• CPC Class Codes: A61B 2017/306 holding by means of suction
• CPC Class Codes: A61B 2017/3405 using mechanical guide means
• CPC Class Codes: A61B 2017/3492 against the outside of the body
• CPC Class Codes: A61B 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/00232 having an irregular shape
• CPC Class Codes: A61B 2018/00261 : arranged in a line
• CPC Class Codes: A61B 2018/00291 : using suction
• CPC Class Codes: A61B 2018/00363 : Epicardium
• CPC Class Codes: A61B 2018/00392 : Transmyocardial revascularisation
• CPC Class Codes: A61B 2018/00577 : Ablation
• CPC Class Codes: A61B 2090/064 : for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 2090/306 : using optical fibres
• CPC Class Codes: A61B 90/50 : Supports for surgical instruments, e.g. articulated arms
• CPC Class Codes: A61F 2/2427 : Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61M 1/3613 : Reperfusion, e.g. of the coronary vessels, e.g. retroperfusion
• CPC Class Codes: A61M 1/3621 : Extra-corporeal blood circuits single-needle circuits A61M1/30
• CPC Class Codes: A61M 1/3653 : Interfaces between patient blood circulation and extra-corporal blood circuit
• CPC Class Codes: A61M 1/3659 : Cannulae pertaining to extracorporeal circulation
• CPC Class Codes: A61M 2025/0002 : with a pressure sensor at the distal end
• CPC Class Codes: A61M 2025/0004 : having two or more concentrically arranged tubes for forming a concentric catheter system
• CPC Class Codes: A61M 2025/0031 : characterized by lumina for withdrawing or delivering, i.e. used for extracorporeal circuit treatment
• CPC Class Codes: A61M 2025/0046 : Coatings for improving slidability
• CPC Class Codes: A61M 2025/0078 : for fluid inflow from the body into the catheter lumen
• CPC Class Codes: A61M 2025/015 : Details of the distal fixation of the movable mechanical means
• CPC Class Codes: A61M 2025/0161 : wherein the distal tips have two or more deflection regions
• CPC Class Codes: A61M 2025/028 : having a mainly rigid support structure
• CPC Class Codes: A61M 2025/1047 : having centering means, e.g. balloons having an appropriate shape
• CPC Class Codes: A61M 2025/105 : having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2025/1052 : for temporarily occluding a vessel for isolating a sector
• 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
• CPC Class Codes: A61M 2025/1077 : having a system for expelling the air out of the balloon before inflation and use
• CPC Class Codes: A61M 2025/1095 : with perfusion means for enabling blood circulation while the balloon is in an inflated state or in a deflated state, e.g. permanent by-pass within catheter shaft
• CPC Class Codes: A61M 2202/047 : cardioplegic
• CPC Class Codes: A61M 2205/11 : with means for preventing cross-contamination when used for multiple patients
• CPC Class Codes: A61M 2205/3344 : Measuring or controlling pressure at the body treatment site
• CPC Class Codes: A61M 2205/3355 : Controlling downstream pump pressure
• CPC Class Codes: A61M 2205/366 : by liquid heat exchangers
• CPC Class Codes: A61M 2210/125 : Heart
• CPC Class Codes: A61M 2210/127 : Aorta
• CPC Class Codes: A61M 25/0023 : by the form of the lumen, e.g. cross-section, variable diameter
• CPC Class Codes: A61M 25/0028 : characterized by features relating to at least one lumen located at the proximal part of the catheter, e.g. alterations in lumen shape or valves catheter hubs A61M25/0097
• CPC Class Codes: A61M 25/0032 : characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts
• CPC Class Codes: A61M 25/0041 : pre-formed, e.g. specially adapted to fit with the anatomy of body channels urethral catheters A61F2/04
• CPC Class Codes: A61M 25/0054 : with regions for increasing flexibility
• CPC Class Codes: A61M 25/0125 : Catheters carried by the bloodstream, e.g. with parachutes; Balloon catheters specially designed for this purpose
• CPC Class Codes: A61M 25/0147 : with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/0152 : with pre-shaped mechanisms, e.g. pre-shaped stylets or pre-shaped outer tubes
• CPC Class Codes: A61M 25/0155 : with hydraulic or pneumatic means, e.g. balloons or inflatable compartments
• CPC Class Codes: A61M 25/0662 : Guide tubes
• 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 25/1011 : Multiple balloon catheters
• CPC Class Codes: A61M 25/1029 : Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
• CPC Class Codes: A61M 25/1034 : Joining of shaft and balloon
• CPC Class Codes: A61M 25/1038 : Wrapping or folding devices for use with balloon catheters
• CPC Class Codes: A61M 39/0247 : Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body peritoneal dialysis catheters A61M1/285; tracheostomy devices A61M16/0465; measuring pressure within the body A61B5/03; colostomy devices A61F5/445; gastrotomy feeding tubes A61J15/0015; means for fixing a feeding tube outside of the body A61J15/0053

Abstract

Devices and methods are provided for temporarily inducing cardioplegic arrest in the heart of a patient and for establishing cardiopulmonary bypass in order to facilitate surgical procedures on the heart and its related blood vessels. Specifically, a catheter based system is provided for isolating the heart and coronary blood vessels of a patient from the remainder of the arterial system and for infusing a cardioplegic agent into the patient'"'"'s coronary arteries to induce cardioplegic arrest in the heart. The system includes an endoaortic partitioning catheter having an expandable balloon at its distal end which is expanded within the ascending aorta to occlude the aortic lumen between the coronary ostia and the brachiocephalic artery. Means for centering the catheter tip within the ascending aorta include specially curved shaft configurations, eccentric or shaped occlusion balloons and a steerable catheter tip, which may be used separately or in combination. The shaft of the catheter may have a coaxial or multilumen construction. The catheter may further include piezoelectric pressure transducers at the distal tip of the catheter and within the occlusion balloon. Means to facilitate nonfluoroscopic placement of the catheter include fiberoptic transillumination of the aorta and a secondary balloon at the distal tip of the catheter for atraumatically contacting the aortic valve. The system further includes a dual purpose arterial bypass cannula and introducer sheath for introducing the catheter into a peripheral artery of the patient.

Claims

1. A catheter device for partitioning a patient'"'"'s ascending aorta between the coronary ostia and the brachiocephalic artery, comprising:

an elongated shaft having a distal end, a proximal end, a first inner lumen extending therebetween, an opening at the distal end in fluid communication with the first inner lumen; and

an expandable means near the distal end of the shaft proximal to the opening in the first inner lumen for occluding the ascending aorta between the coronary ostia and the brachiocephalic artery so as to block substantially all systolic and diastolic blood flow therethrough, said expandable means being expandable eccentrically such that said expandable means has a first side and a second side, said first side expanding to a larger size than said second side.

2. The catheter device of

claim 1

wherein said elongated shaft has a preshaped distal portion configured to conform generally to the patient'"'"'s aortic arch such that the distal end is positionable within the ascending aorta.

3. The catheter device of

claim 2

wherein said preshaped distal portion of said elongated shaft has a curvature with an inner side of the curve and an outer side of the curve and wherein said expandable means is oriented on said catheter shaft such that the larger first side of said expandable means is oriented toward the outer side of the curve and the second side of said expandable means is oriented toward the inner side of the curve.

4. The catheter device of

claim 3

wherein the curvature of said preshaped distal portion of said elongated shaft subtends an angle of about 135°

to about 225°

.

5. The catheter device of

claim 1

wherein said expandable means comprises an inflatable elastomeric balloon.

6. The catheter device of

claim 5

wherein said elongated shaft has a a second inner lumen in fluid communication with an interior space within said inflatable elastomeric balloon.

7. The catheter device of

claim 5

wherein the second side of said inflatable elastomeric balloon is more resistant to expansion than the first side of said inflatable elastomeric balloon.

8. The catheter device of

claim 7

wherein the second side of said inflatable elastomeric balloon has a balloon wall thickness which is greater than the balloon wall thickness of the first side of said inflatable elastomeric balloon.

9. The catheter device of

claim 1

wherein said expandable means comprises an inflatable inelastic balloon.

10. The catheter device of

claim 5

wherein said elongated shaft has a a second inner lumen in fluid communication with an interior space within said inflatable elastomeric balloon.

11. The catheter device of

claim 1

wherein said expandable means comprises an inflatable balloon having at least a portion of the second side of the inflatable balloon attached to said elongated shaft thereby restricting expansion of the second side of the inflatable balloon.

12. The catheter device of

claim 1

wherein said elongated shaft comprises a third inner lumen in fluid communication with a second opening in said elongated shaft distal to said expandable means.

13. A catheter device for partitioning a patient'"'"'s ascending aorta between the coronary ostia and the brachiocephalic artery, comprising:

an elongated shaft having a distal end, a proximal end, a first inner lumen extending therebetween, and an opening at the distal end in fluid communication with the first inner lumen; and

an expandable means near the distal end of the shaft proximal to the opening in the first inner lumen for occluding the ascending aorta between the coronary ostia and the brachiocephalic artery so as to block substantially all systolic and diastolic blood flow therethrough, said expandable means having a distal occlusive means for occluding the ascending aorta and a proximal stabilizing means for stabilizing said expandable means in a desired position within the ascending aorta.

14. The catheter device of

claim 13

wherein said proximal stabilizing means does not occlude the ascending aorta.

15. The catheter device of

claim 13

wherein said proximal stabilizing means does not block blood flow from the ascending aorta into the brachiocephalic artery.

16. The catheter device of

claim 13

wherein said expandable means comprises an inflatable balloon.

17. The catheter device of

claim 16

wherein said distal occlusive means comprises a distal portion of said inflatable balloon of sufficient diameter to occlude the ascending aorta and said proximal stabilizing means comprises a proximal portion of said inflatable balloon having means for contacting an inner surface of the ascending aorta for stabilizing said expandable means in a desired position within the ascending aorta and at least one blood flow passage for allowing blood flow from the ascending aorta into the brachiocephalic artery.

18. The catheter device of

claim 16

wherein said distal occlusive means comprises a distal portion of said inflatable balloon of sufficient diameter to occlude the ascending aorta and said proximal stabilizing means comprises a proximal portion of said inflatable balloon of sufficient diameter to contact an inner surface of the ascending aorta.

19. The catheter device of

claim 18

wherein said inflatable balloon further comprises a region of reduced diameter between said distal portion and said proximal portion of said inflatable balloon.

20. A catheter device for partitioning a patient'"'"'s ascending aorta between the coronary ostia and the brachiocephalic artery, comprising:

an elongated shaft comprising an inner tubular member within an outer tubular member, said inner tubular member having a distal end, a proximal end, a first inner lumen extending therebetween, and an opening at the distal end in fluid communication with the first inner lumen, a flow passage between said inner tubular member and said outer tubular member and

an inflatable balloon near the distal end of the shaft proximal to the opening in the first inner lumen for occluding the ascending aorta between the coronary ostia and the brachiocephalic artery so as to block substantially all systolic and diastolic blood flow therethrough, an interior space within said inflatable balloon being in fluid communication with said flow passage.

21. The catheter device of

claim 20

wherein said inflatable balloon has a distal end attached to said inner tubular member and a proximal end attached to said outer tubular member.

22. The catheter device of

claim 20

further comprising a pressure transducer means for measuring fluid pressure mounted on said elongated shaft distal to said expandable means.

23. The catheter device of

claim 22

further comprising a second pressure transducer means for measuring fluid pressure mounted on said elongated shaft within said expandable means.

24. The catheter device of

claim 20

wherein said inner tubular member comprises a third inner lumen in fluid communication with a second opening in said inner tubular member distal to said expandable means.

25. The catheter device of

claim 21

wherein said inner tubular member is axially movable with respect to said outer tubular member.

26. The catheter device of

claim 25

further comprising a locking means for selectively locking said inner tubular in a desired position with respect to said outer tubular member.

27. The catheter device of

claim 25

wherein said catheter device has a collapsed position in which said inflatable balloon is deflated and said outer tubular member is withdrawn proximally with respect to said inner tubular member thereby collapsing said inflatable balloon around said inner tubular member.

28. The catheter device of

claim 25

wherein said catheter device has a deployed position in which said inflatable balloon is inflated and said outer tubular member is advanced distally with respect to said inner tubular member.

29. The catheter device of

claim 28

when said catheter device is in said deployed position said inflatable balloon has a length-to-diameter ratio of less than about 1.

30. The catheter device of

claim 25

wherein said catheter device has a first deployed position in which said outer tubular member is advanced distally to an intermediate position with respect to said inner tubular member and said inflatable balloon is inflated to a generally spherical shape, and a second deployed position in which said outer tubular member is advanced distally with respect to said inner tubular member and said inflatable balloon is inflated to a generally toroidal shape.

31. The catheter device of

claim 25

wherein said catheter device is selectively deployable by advancing said outer tubular member distally to a selected position with respect to said inner tubular member and inflating said inflatable balloon whereby said balloon is selectively deployed to have a length-to-diameter ratio of less than 1, equal to about 1, or greater than 1.

32. The catheter device of

claim 24

wherein said inner tubular member is rotatable with respect to said outer tubular member.

33. The catheter device of

claim 32

wherein said catheter device has a collapsed position in which said inflatable balloon is deflated and said outer tubular member is rotated with respect to said inner tubular member thereby twisting said inflatable balloon around said inner tubular member.

34. The catheter device of

claim 21

wherein said inner tubular member is rotatable and axially movable with respect to said outer tubular member.

35. The catheter device of

claim 34

wherein said catheter device has a collapsed position in which said inflatable balloon is deflated and said outer tubular member is withdrawn proximally and rotated with respect to said inner tubular member thereby collapsing and twisting said inflatable balloon around said inner tubular member.

36. A catheter device for partitioning a patient'"'"'s ascending aorta between the coronary ostia and the brachiocephalic artery, comprising:

an elongated shaft having a distal end, a proximal end, a first inner lumen extending therebetween, and an opening at the distal end in fluid communication with the first inner lumen; and

an expandable means near the distal end of the shaft proximal to the opening in the first inner lumen for occluding the ascending aorta between the coronary ostia and the brachiocephalic artery so as to block substantially all systolic and diastolic blood flow therethrough; and

a pressure transducer means for measuring fluid pressure mounted on said elongated shaft.

37. The catheter device of

claim 36

wherein said pressure transducer means is mounted on said elongated shaft distal to said expandable means.

38. The catheter device of

claim 36

wherein said pressure transducer means is mounted on said elongated shaft within said expandable means.

39. The catheter device of

claim 38

further comprising a second pressure transducer means for measuring fluid pressure mounted on said elongated shaft distal to said expandable means.

40. A balloon catheter comprising:

an elongated shaft comprising an inner tubular member within an outer tubular member, said inner tubular member having a distal end, a proximal end, a first inner lumen and a second inner lumen extending therebetween, a first opening at the distal end in fluid communication with the first inner lumen, and a second opening at the distal end in fluid communication with the second inner lumen; and

an inflatable balloon near the distal end of the shaft, an interior space within said inflatable balloon being in fluid communication with an inflation lumen defined by a space between said inner tubular member and said outer tubular member.

41. The catheter device of

claim 40

wherein said inflatable balloon has an inflated diameter sufficient for occluding the ascending aorta between the coronary ostia and the brachiocephalic artery so as to block substantially all systolic and diastolic blood flow therethrough

42. A catheter device for partitioning a patient'"'"'s ascending aorta between the coronary ostia and the brachiocephalic artery, comprising:

an elongated shaft having a distal end, a proximal end, a first inner lumen extending therebetween, and an opening at the distal end in fluid communication with the first inner lumen;

a first expandable means near the distal end of the shaft proximal to the opening in the first inner lumen for occluding the ascending aorta between the coronary ostia and the brachiocephalic artery so as to block substantially all systolic and diastolic blood flow therethrough; and

a second expandable means near the distal end of the shaft distal to the first expandable means for protecting the distal end of the shaft from contact with an inner surface of the ascending aorta.

43. The catheter device of

claim 42

wherein said first expandable means comprises a first inflatable balloon.

44. The catheter device of

claim 42

wherein said second expandable means comprises a second inflatable balloon.

45. The catheter device of

claim 44

wherein said second inflatable balloon has a distal end which is inverted and attached to said shaft proximate said distal end of the shaft.

46. A catheter device for partitioning a patient'"'"'s ascending aorta between the coronary ostia and the brachiocephalic artery, comprising:

an elongated shaft having a distal end, a proximal end, a first inner lumen extending therebetween, an opening at the distal end in fluid communication with the first inner lumen, and a preshaped distal portion having a curvature which subtends an angle of about 225°

to about 315°

; and

expandable means near the distal end of the shaft proximal to the opening in the first inner lumen for occluding the ascending aorta between the coronary ostia and the brachiocephalic artery so as to block substantially all systolic and diastolic blood flow therethrough.

47. The catheter device of

claim 46

wherein said expandable means comprises an inflatable balloon.

48. The catheter device of

claim 46

wherein said preshaped distal portion has a first segment contiguous with a proximal portion of the shaft, said first segment having a first radius of curvature, and a second segment contiguous with said first segment, said second segment having a second radius of curvature less than said first radius of curvature.

49. The catheter device of

claim 48

wherein said preshaped distal portion is configured such that when said catheter device is inserted into the patient'"'"'s aorta the distal end resides in the ascending aorta, the second segment extends from the ascending aorta over the aortic arch and the first segment resides in the descending aorta.

50. The catheter device of

claim 48

wherein said preshaped distal portion further comprises a generally straight third segment contiguous with said second segment.

51. The catheter device of

claim 50

wherein said third segment is angled relative to said second segment.

52. The catheter device of

claim 50

wherein said third segment is skewed relative to said proximal portion of the shaft.

53. The catheter device of

claim 46

wherein said preshaped distal portion has a distal segment which is skewed relative to a proximal portion of the shaft.

54. The catheter device of

claim 46

further comprising means for straightening the distal portion of the shaft to facilitate introducing the shaft into an artery downstream of the patient'"'"'s ascending aorta.

55. A catheter device for partitioning a patient'"'"'s ascending aorta between the coronary ostia and the brachiocephalic artery, comprising:

an elongated shaft having a distal end, a proximal end, and an inflation lumen extending therebetween; and

an inflatable balloon near the distal end of the shaft for occluding the ascending aorta between the coronary ostia and the brachiocephalic artery so as to block substantially all systolic and diastolic blood flow therethrough, an interior space within said inflatable balloon being in fluid communication with said inflation lumen, said inflation lumen being configured to allow inflation of said interior space of said inflatable balloon to a volume of about 40 cc with an aqueous inflation medium in a time of less than about 40 seconds.

56. The catheter device of

claim 55

wherein said inflation lumen is configured to allow inflation of said interior space of said inflatable balloon to a volume of about 40 cc with an aqueous inflation medium in a time of less than about 20 seconds.

57. The catheter device of

claim 55

wherein said elongated shaft has a length sufficient to allow said distal end to be positioned in the patient'"'"'s ascending aorta with said proximal end extending out of a peripheral artery of the patient.

58. The catheter device of

claim 57

wherein said elongated shaft has a length of at least 80 cm to facilitate transluminal positioning from a femoral artery to the ascending aorta.

59. The catheter device of

claim 55

wherein said inflatable balloon is inflatable to a volume of about 40 cc with an aqueous inflation medium in a time of less than about 40 seconds with an inflation pressure not exceeding 35 psi measured at the proximal end of said inflation lumen.

60. The catheter device of

claim 55

wherein said elongated shaft further comprises an infusion lumen extending between the proximal end and the distal end of the shaft, and an opening in said shaft distal to said inflatable balloon in fluid communication with the infusion lumen.

61. The catheter device of

claim 55

wherein said inflation lumen has a cross sectional area of at least 0.5 mm².

62. The catheter device of

claim 55

wherein said inflatable balloon is inflatable to a volume of about 40 cc with an aqueous inflation medium containing a radiopaque contrast agent in a time of less than about 40 seconds.

63. A catheter device for partitioning a patient'"'"'s ascending aorta between the coronary ostia and the brachiocephalic artery, comprising:

an elongated shaft having a distal end, a proximal end, a first inner lumen extending therebetween, an opening at the distal end in fluid communication with the first inner lumen, and a preshaped distal portion configured to conform generally to the patient'"'"'s aortic arch such that the distal end is positionable within the ascending aorta with the distal end of the elongated shaft in proximity to an anterior wall of the ascending aorta; and

an expandable means near the distal end of the shaft proximal to the opening in the first inner lumen for occluding the ascending aorta between the coronary ostia and the brachiocephalic artery so as to block substantially all systolic and diastolic blood flow therethrough.

64. A method of partitioning a patient'"'"'s ascending aorta between the patient'"'"'s coronary ostia and the patient'"'"'s brachiocephalic artery, comprising:

introducing a distal end of a shaft of an aortic partitioning device into a blood vessel downstream of the patient'"'"'s ascending aorta;

transluminally positioning the shaft so that the distal end of the shaft is in the ascending aorta and an expandable occluding member attached to the shaft near the distal end is disposed between the coronary ostia and the brachiocephalic artery; and

expanding the occluding member eccentrically about the shaft of the aortic partitioning device within the ascending aorta to completely block blood flow therethrough.

65. The method of

claim 64

wherein the occluding member is eccentrically expanded about the shaft of the aortic partitioning device with a larger side of the occluding member oriented toward the outside of the greater curvature of the patient'"'"'s aortic arch.

66. The method of

claim 64

wherein the shaft of the aortic partitioning device is positioned with a curved portion of the shaft within the patient'"'"'s aortic arch.

67. The method of

claim 66

wherein the curved portion of the shaft conforms generally to the curve of the patient'"'"'s aortic arch and the occluding member is eccentrically expanded about the shaft of the aortic partitioning device with a larger side of the occluding member oriented the outside of the greater curvature of the patient'"'"'s aortic arch.

68. The method of

claim 64

further comprising the step of infusing a cardioplegic agent through a lumen within the shaft having an opening distal to the occluding member.

69. A method of partitioning a patient'"'"'s ascending aorta between the patient'"'"'s coronary ostia and the patient'"'"'s brachiocephalic artery, comprising:

introducing a distal end of a shaft of an aortic partitioning device into a blood vessel downstream of the patient'"'"'s ascending aorta;

transluminally positioning the shaft so that the distal end of the shaft is in the ascending aorta and an expandable occluding member attached to the shaft near the distal end is disposed between the coronary ostia and the brachiocephalic artery and a nonocclusive stabilizing member is positioned downstream of the occluding member; and

expanding the occluding member within the ascending aorta to completely block blood flow therethrough and expanding the stabilizing member to contact an inner wall of the aorta.

70. The method of

claim 69

wherein the step of expanding the occluding member and the stabilizing member comprises the substep of inflating an expandable balloon having the occluding member located on a distal portion of the balloon and the stabilizing member located on a proximal portion of the balloon.

71. The method of

claim 69

wherein the expandable occluding member is expanded in a position immediately upstream of the brachiocephalic artery.

72. The method of

claim 69

wherein the stabilizing member is expanded without the stabilizing member occluding the patient'"'"'s ascending aorta.

73. The method of

claim 69

further comprising the step of positioning a blood flow passage within the stabilizing member to allow blood flow from the ascending aorta into the brachiocephalic artery.

74. A method of partitioning a patient'"'"'s ascending aorta between the patient'"'"'s coronary ostia and the patient'"'"'s brachiocephalic artery, comprising:

introducing a distal end of a shaft of an aortic partitioning device into a blood vessel downstream of the patient'"'"'s ascending aorta, the shaft comprising an inner tubular member within an outer tubular member;

transluminally positioning the shaft so that the distal end of the shaft is in the ascending aorta and an expandable occluding member attached to the shaft near the distal end is disposed between the coronary ostia and the brachiocephalic artery; and

expanding the occluding member within the ascending aorta to completely block blood flow therethrough.

75. The method of

claim 74

wherein the expandable occluding member comprises an inflatable balloon having a distal end attached to said inner tubular member and a proximal end attached to said outer tubular member and wherein the step of expanding the occluding member comprises the substep of inflating the balloon by passing an inflation fluid through a flow passage between the inner tubular member and the outer tubular member.

76. The method of

claim 75

further comprising the step of measuring pressure within the inflatable balloon with a pressure transducer within the inflatable balloon.

77. The method of

claim 74

wherein the step of introducing the distal end of the shaft into a blood vessel is preceded by the step of withdrawing the outer tubular member proximally with respect to the inner tubular member to reduce the profile of the occluding member on the shaft of the aortic partitioning device.

78. The method of

claim 74

wherein the step of introducing the distal end of the shaft into a blood vessel is preceded by the step of rotating the outer tubular member with respect to the inner tubular member to reduce the profile of the occluding member on the shaft of the aortic partitioning device.

79. The method of

claim 74

further comprising the step of measuring aortic pressure distal to the occluding member.

80. The method of

claim 74

further comprising the step of measuring aortic pressure distal to the occluding member with a pressure transducer nearthe distal end of the shaft.

81. The method of

claim 74

further comprising the step of measuring aortic pressure distal to the occluding member with a pressure transducer nearthe distal end of the shaft.

82. A method of partitioning a patient'"'"'s ascending aorta between the patient'"'"'s coronary ostia and the patient'"'"'s brachiocephalic artery, comprising:

introducing a distal end of a shaft of an aortic partitioning device into a blood vessel downstream of the patient'"'"'s ascending aorta, the shaft comprising an inner tubular member within an outer tubular member;

advancing the shaft so that the distal end of the shaft is in the aorta and expanding a distal expandable member attached to the shaft near the distal end of the shaft to protect the distal end of the shaft from contact with an inner surface of the aorta; and

transluminally positioning the shaft so that the distal end of the shaft is in the ascending aorta and an expandable occluding member attached to the shaft proximal to the distal expandable member is disposed between the coronary ostia and the brachiocephalic artery; and

expanding the occluding member within the ascending aorta to completely block blood flow therethrough.

83. The method of

claim 82

wherein the step of transluminally positioning the shaft so that the distal end of the shaft is in the ascending aorta includes the substep of advancing the shaft until the expanded distal expandable member contacts the patient'"'"'s aortic valve.

84. A method of partitioning a patient'"'"'s ascending aorta between the patient'"'"'s coronary ostia and the patient'"'"'s brachiocephalic artery, comprising:

introducing a distal end of a shaft of an aortic partitioning device into a blood vessel downstream of the patient'"'"'s ascending aorta;

transluminally positioning the shaft so that the distal end of the shaft is in the ascending aorta with the distal end of the elongated shaft in proximity to a wall of the ascending aorta which is most elevated and an expandable occluding member attached to the shaft near the distal end is disposed between the coronary ostia and the brachiocephalic artery; and

expanding the occluding member within the ascending aorta to completely block blood flow therethrough.

85. The method of

claim 84

further comprising the step of venting the ascending aorta through a lumen connecting with the distal end of the shaft.

86. The method of

claim 85

including the step of placing the patient supine so that the wall of the ascending aorta which is most elevated is an anterior wall of the ascending aorta and the distal end of the elongated shaft is in proximity to the anterior wall so that any air within the ascending aorta is withdrawn through the lumen of the aortic partitioning device in the venting step.

87. A cannula adapted to permit passage therethrough of a catheter for percutaneous insertion in the body of a patient, said cannula comprising:

a cannula body having a proximal end, a distal end and a cannula lumen,

a first leg connected to said proximal end of said cannula body, said first leg having a blood flow lumen in fluid communication with said cannula lumen,

a second leg having a proximal end and a distal end, said distal end of said second leg being connected to said proximal end of said cannula body, said second leg having a catheter insertion lumen in fluid communication with said cannula lumen,

a first hemostasis means for selectively preventing fluid flow between said cannula lumen and said catheter insertion lumen, and

a second hemostasis means for preventing fluid flow from the proximal end of said catheter insertion lumen, said second hemostasis means being spaced apart from said first hemostasis means to create a catheter insertion chamber within said catheter insertion lumen.

88. The cannula of

claim 87

wherein said second hemostasis means comprises a resilient sealing member having an opening therethrough, and a compression means for compressing said resilient sealing member to selectively occlude said opening.

89. The cannula of

claim 87

wherein said first hemostasis means has an open position which allows free passage of a catheter from said catheter insertion lumen into said cannula lumen.

90. The cannula of

claim 89

wherein said first hemostasis means comprises a flexible tubular member intermediate said proximal end and said distal end of said second leg and an external clamp means for clamping said flexible tubular member to occlude said catheter insertion lumen.

91. The cannula of

claim 87

wherein said second hemostasis means has a closed position which prevents fluid flow from the proximal end of said catheter insertion lumen, and an open position which allows insertion of a catheter through said second hemostasis means into said catheter insertion lumen.

92. The cannula of

claim 91

wherein said second hemostasis means provides an open passage for insertion of a catheter through said second hemostasis means when said second hemostasis means is in said open position.

93. The cannula of

claim 91

wherein said open passage has a diameter of at least 5 mm when said second hemostasis means is in said open position.

94. The cannula of

claim 91

wherein said second hemostasis means provides a sliding hemostatic seal around a shaft of a catheter inserted through said second hemostasis means when said second hemostasis means is in said open position.

95. The cannula of

claim 91

wherein said second hemostasis means has an intermediate position which creates a seal against an external surface of said catheter to prevent fluid flow from the proximal end of said catheter insertion lumen when said catheter is inserted through said second hemostasis means.

96. The cannula of

claim 95

wherein said second hemostasis means provides a sliding hemostatic seal around a shaft of a catheter inserted through said second hemostasis means when said second hemostasis means is in said intermediate position.

97. The cannula of

claim 95

wherein said second hemostasis means is selectively movable between said open position, said closed position and said intermediate position.

98. The cannula of

claim 87

further comprising a third hemostasis means for selectively preventing fluid flow through said cannula lumen.

99. The cannula of

claim 98

wherein said third hemostasis means comprises a flexible tubular member intermediate said proximal end and said distal end of said cannula body and an external clamp means for clamping said flexible tubular member to occlude said cannula lumen.

100. The cannula of

claim 87

further comprising a lubricious coating on an interior surface of said cannula lumen and an interior surface of said catheter insertion lumen.

101. The cannula of

claim 87

further comprising a lubricious coating on an exterior surface of at least a distal portion of said cannula body.

102. The cannula of

claim 87

wherein said cannula body has a tapered distal portion having a distal external diameter which is smaller than a proximal external diameter of said cannula body.

103. The cannula of

claim 87

wherein at least a distal portion of said cannula body is reinforced with a coiled wire embedded in a wall of said cannula body.

104. The cannula of

claim 87

in combination with an aortic partitioning catheter means for occluding a patient'"'"'s ascending aorta between the coronary ostia and the brachiocephalic artery, said aortic partitioning catheter means having a distal end dimensioned for passage through said catheter insertion lumen.

105. An adapter for proximal attachment to a cannula for placement in a blood vessel comprising:

a first leg having a proximal end, a distal end and a first lumen therebetween;

a second leg having having a proximal end, a distal end and a second lumen therebetween, the distal end of the second arm being attached to the first arm such that the second lumen is in fluid communication with the first lumen;

a first hemostasis means in a distal portion of the first arm for selectively preventing fluid flow through the first lumen;

a second hemostasis means in a proximal portion of the first arm for selectively preventing fluid flow through the first lumen; and

means for attaching the adapter to a proximal end of the cannula.

106. A repositionable securing device for securing an elongated medical instrument in a selected position, said repositionable securing device comprising:

a tubular member having a lumen therethrough to slidably receive said elongated medical instrument therein, said lumen having a high friction material on an inner surface of said lumen; and

means for compressing said tubular member around said elongated medical instrument to frictionally secure said tubular member to said elongated medical instrument.

107. The repositionable securing device of

claim 106

wherein said tubular member has a longitudinal slot communicating with said lumen along at least a portion of said tubular member which renders said tubular member more easily compressible around said elongated medical instrument.

108. The repositionable securing device of

claim 106

wherein said high friction material comprises particles adhered to the inner surface of said lumen to increase friction between said inner surface and said elongated medical instrument.

109. The repositionable securing device of

claim 106

wherein said means for compressing said tubular member around said elongated medical instrument comprises a suture or ligature tied around an exterior surface of said tubular member.

110. The repositionable securing device of

claim 106

wherein said exterior surface of said tubular member further comprises a means for securing said suture or ligature to said tubular member.

111. The repositionable securing device of

claim 106

wherein said means for securing said suture or ligature to said tubular member comprises at least one circumferential groove in the exterior surface of said tubular member.

112. The repositionable securing device of

claim 106

wherein said tubular member has a longitudinal slot communicating with said lumen along at least a portion of said tubular member which renders said tubular member more easily compressible around said elongated medical instrument, said high friction material comprises particles adhered to the inner surface of said lumen to increase friction between said inner surface and said elongated medical instrument, said means for compressing said tubular member around said elongated medical instrument comprises a suture or ligature tied around an exterior surface of said tubular member, and said tubular member further comprises at least one circumferential groove in said exterior surface of said tubular member for securing said suture or ligature to said tubular member.