Retrograde coronary sinus catheter

• US 5,620,418 A
• Filed: 12/07/1994
• Issued: 04/15/1997
• Est. Priority Date: 04/27/1992
• Status: Expired due to Term

• Current Assignee: Terumo Cardiovascular Systems Corporation (Terumo Corporation)
• Original Assignee: Minnesota Mining and Manufacturing Co (3M Company)
• Inventors: O'Neill, William G., Carpenter, Walter L., Huldin, Nelson L., Hanson, Sheila J.
• Primary Examiner(s): MCDERMOTT, CORRINE MARIE
• Application Number:
  US08/350,649
• Time in Patent Office: 860 Days
• Field of Search: 604/96-101, 604/103, 606/191, 606/192, 606/194
• US Class Current: 604/103.08
• CPC Class Codes: A61M 2025/0002 with a pressure sensor at the distal end
• CPC Class Codes: A61M 2025/0003 having an additional lumen transmitting fluid pressure to the outside for measurement
• CPC Class Codes: A61M 2025/0081 Soft tip
• CPC Class Codes: A61M 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 2202/0472 cryo-cardioplegic
• CPC Class Codes: A61M 2230/50 Temperature
• CPC Class Codes: A61M 25/0023 by the form of the lumen, e.g. cross-section, variable diameter
• CPC Class Codes: A61M 25/0068 Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/0102 Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• 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 25/10182 Injector syringes
• CPC Class Codes: A61M 25/10186 One-way valves
• CPC Class Codes: A61M 25/1025 Connections between catheter tubes and inflation tubes

Abstract

A coronary sinus catheter for the retrograde infusion of cardioplegia solutions into the coronary sinus. The catheter is adapted for improved retention in the coronary sinus. The catheter comprises a catheter tube having infusion, pressure-sensing and balloon-inflation lumens, an inflatable balloon and a pressure sensor tube in fluid communication with the balloon-inflation lumen for sensing pressure in the inflatable balloon. The internal volume of the pressure sensor tube is relatively non-expansible relative to the internal volume of the inflation balloon in normal operation of the catheter. The balloon includes a plurality of segmented annular ribs.

Claims

1. A coronary sinus catheter for the retrograde infusion of cardioplegia solution into the coronary sinus of a patient'"'"'s heart, the catheter comprising:

a flexible, elongate catheter tube having proximal and distal ends and an outer diameter, and including at least an infusion lumen extending longitudinally through the tube, at least one infusion lumen outlet generally adjacent the distal end of the catheter tube, and means adjacent the proximal end of the catheter tube for connecting a source of cardioplegia solution to the catheter; and

an inflatable balloon on the catheter tube generally adjacent the distal end of the catheter tube proximally of the infusion lumen outlet, the inflatable balloon being expandable as the balloon is inflated from an un-inflated diameter, generally equal to the outer diameter of the catheter tube for introducing the catheter into the coronary sinus, to an inflated diameter, substantially greater than the outer diameter of the catheter tube for securing the distal end of the catheter in the coronary sinus;

the inflatable balloon having a plurality of outwardly-facing, spaced-apart, segmented, annular ribs or lands for frictionally engaging the coronary sinus, each segmented annular rib or land comprising a plurality of solid, raised, generally elongate rib portions separated by non-raised portions extending annularly around the periphery of the balloon in alternating fashion, the non-raised portions preferentially stretching in comparison to the raised rib portions as the balloon is inflated to its inflated diameter, the balloon, including the ribs or lands, being integrally molded of generally uniform elastomeric material; and

the raised rib portions of adjacent ribs or lands being staggered such that the raised rib portions of one rib or land are generally longitudinally aligned with the non-raised portions of the adjacent rib or land.

2. A coronary sinus catheter according to claim 1 wherein:

the plurality of segmented ribs or lands comprises three to seven segmented ribs or lands;

each segmented rib or land having the same number of raised rib portions and non-raised portions as the other ribs or lands; and

the raised rib portions having a generally asymetrical profile along the longitudinal direction of the catheter, the raised rib portions having an upper surface sloping smoothly and gradually forwardly to the surface of the balloon, and a back surface extending from the upper surface more steeply to the surface of the balloon than the upper surface slopes to the surface of the balloon.

3. A coronary sinus catheter according to claim 1 wherein the segmented ribs or lands are integrally molded with the balloon of silicone material constituting the elastomeric material.

4. A coronary sinus catheter according to claim 3 wherein:

the balloon has a wall thickness when not inflated of approximately 0.33-0.48 millimeters.

6. A coronary sinus catheter according to claim 1 wherein the raised rib portions of adjacent ribs or lands are generally aligned along the longitudinal direction of the catheter.

5. A coronary sinus catheter for the retrograde infusion of cardioplegia solution into the coronary sinus of a patient'"'"'s heart, the catheter comprising:

a flexible, elongate catheter tube having proximal and distal ends and an outer diameter, and including at least an infusion lumen extending longitudinally through the tube, at least one infusion lumen outlet generally adjacent the distal end of the catheter tube, and means adjacent the proximal end of the catheter tube for connecting a source of cardioplegia solution to the catheter; and

an inflatable balloon on the catheter tube generally adjacent the distal end of the catheter tube proximally of the infusion lumen outlet, the inflatable balloon being expandable as the balloon is inflated from an un-inflated diameter, generally equal to the outer diameter of the catheter tube for introducing the catheter into the coronary sinus, to an inflated diameter, substantially greater than the outer diameter of the catheter tube for securing the distal end of the catheter in the coronary sinus;

the inflatable balloon having a plurality of outwardly-facing, spaced-apart, segmented, annular ribs or lands for frictionally engaging the coronary sinus, each segmented annular rib or land comprising a plurality of solid, raised, generally elongate rib portions separated by non-raised portions extending annularly around the periphery of the balloon in alternating fashion, the non-raised portions preferentially stretching in comparison to the raised rib portions as the balloon is inflated to its inflated diameter, the balloon, including the ribs or lands, being integrally molded of generally uniform elastomeric material; and

the generally elongate raised rib portions having a direction of elongation extending generally circumferentially along the balloon.

7. A coronary sinus catheter according to claim 5 wherein the raised rib portions have a length along their direction of elongation longer than the distance between adjacent raised rib portions along the non-raised portion separating the adjacent raised rib portions.

8. A coronary sinus catheter according to claim 7 wherein the raised rib portions of one segmented rib or land each have a length along their direction of elongation generally equal to the other raised rib portions of that segmented rib or land.

9. A coronary sinus catheter according to claim 8 wherein the non-raised portions of one segmented rib or land each define a distance between adjacent raised rib portions generally equal to the distance between raised rib portions defined by the other non-raised portions of that segmented rib or land.

10. A coronary sinus catheter according to claim 9 wherein the catheter tube further defines a pressure lumen having lumen outlet generally adjacent the distal end of the catheter tube.

11. A coronary sinus catheter according to claim 10 wherein the balloon is formed of polymeric material having a Shore A hardness of between approximately 20 and 35.

12. A coronary sinus catheter according to claim 11 wherein the balloon is formed of silicone material.

13. A coronary sinus catheter for the retrograde infusion of cardioplegia solution into the coronary sinus of a patient'"'"'s heart, the catheter comprising:

a flexible, elongate catheter tube having proximal and distal ends and an outer diameter, and including at least an infusion lumen extending longitudinally through the tube, at least one infusion lumen outlet generally adjacent the distal end of the catheter tube, and means adjacent the proximal end of the catheter tube for connecting a source of cardioplegia solution to the catheter; and

an inflatable balloon on the catheter tube generally adjacent the distal end of the catheter tube proximally of the infusion lumen outlet, the inflatable balloon being expandable as the balloon is inflated from an un-inflated diameter, generally equal to the outer diameter of the catheter tube for introducing the catheter into the coronary sinus, to an inflated diameter, substantially greater than the outer diameter of the catheter tube for securing the distal end of the catheter in the coronary sinus;

the inflatable balloon having a plurality of outwardly-facing, spaced-apart, segmented, annular ribs or lands for frictionally engaging the coronary sinus, each segmented annular rib or land comprising a plurality of solid, raised, generally elongate rib portions separated by non-raised portions extending annularly around the periphery of the balloon in alternating fashion, the non-raised portions preferentially stretching in comparison to the raised rib portions as the balloon is inflated to its inflated diameter, the balloon, including the ribs or lands, being integrally molded of generally uniform elastomeric material; and

the raised rib portions having a generally asymmetrical profile along the longitudinal direction of the catheter, the raised rib portions having an upper surface sloping smoothly and gradually in the distal direction to the surface of the balloon, and a proximal surface extending from the upper surface more steeply to the surface of the balloon than the upper surface slopes to the surface of the balloon.

14. A coronary sinus catheter for the retrograde infusion of cardioplegia solution into the coronary sinus of a patient'"'"'s heart, the catheter comprising:

a flexible, elongate catheter tube having proximal and distal ends and an outer diameter, and including at least an infusion lumen extending longitudinally through the tube, at least one infusion lumen outlet generally adjacent the distal end of the catheter tube, and means adjacent the proximal end of the catheter tube for connecting a source of cardioplegia solution to the catheter; and

an inflatable balloon on the catheter tube generally adjacent the distal end of the catheter tube proximally of the infusion lumen outlet;

the inflatable balloon having a plurality of outwardly-facing, spaced-apart, segmented, annular ribs or lands for engaging the coronary sinus, each segmented annular rib or land comprising a plurality of solid, raised rib portions separated by non-raised portions extending annularly around the periphery of the balloon in alternating fashion;

wherein the raised rib portions have a generally asymmetrical profile along the longitudinal direction of the catheter, the raised rib portions having an upper surface sloping smoothly and gradually in the distal direction to the surface of the balloon, and a proximal surface extending from the upper surface more steeply to the surface of the balloon than the upper surface slopes to the surface of the balloon.

15. A coronary sinus catheter according to claim 14 wherein the raised rib portions are generally elongate having a direction of elongation extending generally circumferentially along the balloon.

16. A coronary sinus catheter according to claim 15 wherein the raised rib portions have a length along their direction of elongation longer than the distance between adjacent raised rib portions along the non-raised portion separating the adjacent raised rib portions.

17. A coronary sinus catheter according to claim 16 wherein the raised rib portions of one segmented rib or land each have a length along their direction of elongation generally equal to the other raised rib portions of that segmented rib or land.

18. A coronary sinus catheter according to claim 17 wherein the non-raised portions of one segmented rib or land each define a distance between adjacent raised rib portions generally equal to the distance between raised rib portions defined by the other non-raised portions of that segmented rib or land.

19. A coronary sinus catheter according to claim 18 wherein the catheter tube further defines a pressure lumen having lumen outlet generally adjacent the distal end of the catheter tube.

20. A coronary sinus catheter according to claim 19 wherein the balloon and rib portions are integrally formed of elastomeric material having a Shore A hardness of between approximately 20 and 35.

21. A coronary sinus catheter according to claim 20 wherein the balloon and rib portions are integrally formed of silicone material.

22. A coronary sinus catheter according to claim 15 wherein the raised rib portions of adjacent ribs or lands are staggered such that the raised rib portions of one rib or land are generally longitudinally aligned with the non-raised portions of the adjacent rib or land.

23. A coronary sinus catheter according to claim 15 wherein each segmented rib or land has the same number of raised rib portions and non-raised portions as the other ribs or lands.

24. A coronary sinus catheter according to claim 15 wherein the plurality of segmented ribs or lands comprises three to seven segmented ribs or lands.

25. A coronary sinus catheter according to claim 16 wherein the raised rib portions of adjacent ribs or lands are staggered such that the raised rib portions of one rib or land are generally longitudinally aligned with the non-raised portions of the adjacent rib or land.

26. A coronary sinus catheter according to claim 17 wherein the raised rib portions of adjacent ribs or lands are staggered such that the raised rib portions of one rib or land are generally longitudinally aligned with the non-raised portions of the adjacent rib or land.

27. A coronary sinus catheter according to claim 14 wherein the raised rib portions are generally elongate each having a length along its direction of elongation longer than the distance between adjacent raised rib portions along the non-raised portion separating the adjacent raised rib portions.

28. A coronary sinus catheter according to claim 27 wherein the raised rib portions of one segmented rib or land each have a length along their direction of elongation generally equal to the other raised rib portions of that segmented rib or land.

29. A coronary sinus catheter according to claim 28 wherein the non-raised portions of one segmented rib or land each define a distance between adjacent raised rib portions generally equal to the distance between raised rib portions defined by the other non-raised portions of that segmented rib or land.

30. A coronary sinus catheter according to claim 14 wherein the raised rib portions of one segmented rib or land are generally elongate, each rib portion having a length along its direction of elongation generally equal to the other raised rib portions of that segmented rib or land.

31. A coronary sinus catheter according to claim 30 wherein the plurality of segmented ribs or lands comprises three to seven segmented ribs or lands.

32. A coronary sinus catheter according to claim 30 wherein the non-raised portions of one segmented rib or land each define a distance between adjacent raised rib portions generally equal to the distance between raised rib portions defined by the other non-raised portions of that segmented rib or land.

33. A coronary sinus catheter according to claim 14 wherein the non-raised portions of one segmented rib or land each define a distance between adjacent raised rib portions generally equal to the distance between raised rib portions defined by the other non-raised portions of that segmented rib or land.

34. A coronary sinus catheter according to claim 33 wherein the raised rib portions of adjacent ribs or lands are staggered such that the raised rib portions of one rib or land are generally longitudinally aligned with the non-raised portions of the adjacent rib or land.

35. A coronary sinus catheter according to claim 14 wherein the catheter tube further defines a pressure lumen having lumen outlet generally adjacent the distal end of the catheter tube.

36. A coronary sinus catheter according to claim 35 wherein the balloon and rib portions are integrally formed of elastomeric material having a Shore A hardness of between approximately 20 and 35.

37. A coronary sinus catheter according to claim 35 wherein the raised rib portions of adjacent ribs or lands are staggered such that the raised rib portions of one rib or land are generally longitudinally aligned with the non-raised portions of the adjacent rib or land.

38. A coronary sinus catheter according to claim 14 wherein the balloon and rib portions are integrally formed of elastomeric material having a Shore A hardness of between approximately 20 and 35.

39. A coronary sinus catheter according to claim 14 wherein the balloon and rib portions are integrally formed of silicone material.

40. A coronary sinus catheter according to claim 14 wherein the plurality of segmented ribs or lands comprises three to seven segmented ribs or lands.

41. A coronary sinus catheter according to claim 40 wherein the plurality of segmented ribs or lands comprises six segmented ribs or lands.

42. A coronary sinus catheter according to claim 14 wherein each segmented rib or land has the same number of raised rib portions and non-raised portions as the other ribs or lands.

43. A coronary sinus catheter according to claim 14 wherein the raised rib portions of adjacent ribs or lands are staggered such that the raised rib portions of one rib or land are generally longitudinally aligned with the non-raised portions of the adjacent rib or land.

44. A coronary sinus catheter according to claim 14 wherein the balloon comprises a molded balloon having two tubular extensions that are glued to the catheter tube to mount the balloon on the catheter tube.

45. A coronary sinus catheter for the retrograde infusion of cardioplegia solution into the coronary sinus of a patient'"'"'s heart, the catheter comprising:

a flexible, elongate catheter tube having proximal and distal ends and an outer diameter, and including at least an infusion lumen extending longitudinally through the tube, at least one infusion lumen outlet generally adjacent the distal end of the catheter tube, and means adjacent the proximal end of the catheter tube for connecting a source of cardioplegia solution to the catheter; and

an inflatable balloon on the catheter tube generally adjacent the distal end of the catheter tube proximally of the infusion lumen outlet, the inflatable balloon being expandable as the balloon is inflated from an un-inflated diameter, generally equal to the outer diameter of the catheter tube for introducing the catheter into the coronary sinus, to an inflated diameter, substantially greater than the outer diameter of the catheter tube for securing the distal end of the catheter in the coronary sinus;

the inflatable balloon having a plurality of outwardly-facing, spaced-apart, segmented, annular ribs or lands for engaging the coronary sinus, each segmented annular rib or land comprising a plurality of solid, raised, generally elongate rib portions separated by non-raised portions extending annularly around the periphery of the balloon in alternating fashion;

wherein the raised rib portions have a generally asymmetrical profile along the longitudinal direction of the catheter, the raised rib portions having an upper surface sloping smoothly and gradually in the distal direction to the surface of the balloon, and a proximal surface extending from the upper surface more steeply to the surface of the balloon than the upper surface slopes to the surface of the balloon.

46. A coronary sinus catheter according to claim 45 wherein the plurality of segmented ribs or lands comprises three to seven segmented ribs or lands.

47. A coronary sinus catheter according to claim 46 wherein each segmented rib or land has the same number of raised rib portions and non-raised portions as the other ribs or lands.

48. A coronary sinus catheter according to claim 45 wherein the raised rib portions of adjacent ribs or lands are staggered such that the raised rib portions of one rib or land are generally longitudinally aligned with the non-raised portions of the adjacent rib or land.

49. A coronary sinus catheter for the retrograde infusion of cardioplegia solution into the coronary sinus of a patient'"'"'s heart, the catheter comprising:

a flexible, elongate catheter tube having proximal and distal ends and an outer diameter, and including at least an infusion lumen extending longitudinally through the tube, at least one infusion lumen outlet generally adjacent the distal end of the catheter tube, and means adjacent the proximal end of the catheter tube for connecting a source of cardioplegia solution to the catheter; and

an inflatable balloon on the catheter tube generally adjacent the distal end of the catheter tube proximally of the infusion lumen outlet, the inflatable balloon being expandable as the balloon is inflated from an un-inflated diameter, generally equal to the outer diameter of the catheter tube for introducing the catheter into the coronary sinus, to an inflated diameter, substantially greater than the outer diameter of the catheter tube for securing the distal end of the catheter in the coronary sinus;

the inflatable balloon having a plurality of outwardly-facing, spaced-apart, segmented, annular ribs or lands for engaging the coronary sinus, each segmented annular rib or land comprising a plurality of solid, raised, generally elongate rib portions separated by non-raised portions extending annularly around the periphery of the balloon in alternating fashion;

the balloon comprising a molded balloon having two tubular extensions that are glued to the catheter tube to mount the balloon on the catheter tube; and

the tubular extensions including annular ribs extending radially inwardly adjacent the expandable portion of the balloon to provide an even glue line adjacent the expandable portion of the balloon.

50. A coronary sinus catheter according to claim 49 wherein the raised rib portions have a generally asymmetrical profile along the longitudinal direction of the catheter, the raised rib portions having an upper surface sloping smoothly and gradually in the distal direction to the surface of the balloon, and a proximal surface extending from the upper surface more steeply to the surface of the balloon than the upper surface slopes to the surface of the balloon.

51. A coronary sinus catheter according to claim 50 wherein the plurality of segmented ribs or lands comprises three to seven segmented ribs or lands.

52. A coronary sinus catheter according to claim 51 wherein each segmented rib or land has the same number of raised rib portions and non-raised portions as the other ribs or lands.

53. A coronary sinus catheter according to claim 51 wherein the raised rib portions of adjacent ribs or lands are staggered such that the raised rib portions of one rib or land are generally longitudinally aligned with the non-raised portions of the adjacent rib or land.

54. A coronary sinus catheter according to claim 49 wherein the raised rib portions of adjacent ribs or lands are staggered such that the raised rib portions of one rib or land are generally longitudinally aligned with the non-raised portions of the adjacent rib or land.

55. A coronary sinus catheter for the retrograde infusion of cardioplegia solution into the coronary sinus of a patient'"'"'s heart, the catheter comprising:

a flexible, elongate catheter tube having proximal and distal ends and an outer diameter, and including at least an infusion lumen extending longitudinally through the tube, at least one infusion lumen outlet generally adjacent the distal end of the catheter tube, and means adjacent the proximal end of the catheter tube for connecting a source of cardioplegia solution to the catheter; and

an inflatable balloon on the catheter tube generally adjacent the distal end of the catheter tube proximally of the infusion lumen outlet, the inflatable balloon being expandable as the balloon is inflated from an un-inflated diameter, generally equal to the outer diameter of the catheter tube for introducing the catheter into the coronary sinus, to an inflated diameter, substantially greater than the outer diameter of the catheter tube for securing the distal end of the catheter in the coronary sinus;

the inflatable balloon having a plurality of outwardly-facing, spaced-apart, segmented, annular ribs or lands for engaging the coronary sinus, each segmented annular rib or land comprising a plurality of solid, raised, generally elongate rib portions separated by non-raised portions extending annularly around the periphery of the balloon in alternating fashion;

wherein the generally elongate raised rib portions have a direction of elongation extending generally circumferentially along the balloon, the raised rib portions having a length along their direction of elongation longer than the distance between adjacent raised rib portions along the non-raised portion separating the adjacent raised rib portions;

the raised rib portions of one segmented rib or land each have a length along their direction of elongation generally equal to the other raised rib portions of that segmented rib or land;

the non-raised portions of one segmented rib or land each defining a distance between adjacent raised rib portions generally equal to the distance between raised rib portions defined by the other non-raised portions of that segmented rib or land;

the catheter tube further defining a pressure lumen having lumen outlet generally adjacent the distal end of the catheter tube;

the balloon and rib portions are integrally formed of elastomeric silicone material having a Shore A hardness of between approximately 20 and 35;

wherein the raised rib portions have a generally asymmetrical profile along the longitudinal direction of the catheter, the raised rib portions having an upper surface sloping smoothly and gradually in the distal direction to the surface of the balloon, and a proximal surface extending from the upper surface more steeply to the surface of the balloon than the upper surface slopes to the surface of the balloon;

the plurality of segmented ribs or lands comprising three to seven segmented ribs or lands;

the balloon comprising a molded balloon having two tubular extensions that are glued to the catheter tube to mount the balloon on the catheter tube; and

the tubular extensions including annular ribs extending radially inwardly adjacent the expandable portion of the balloon to provide an even glue line adjacent the expandable portion of the balloon.

56. A coronary sinus catheter assembly for the retrograde infusion of cardioplegia solution into the coronary sinus of a patient'"'"'s heart, the catheter assembly comprising:

a catheter comprising;

a flexible, elongate catheter tube having proximal and distal ends and an outer diameter, and including at least an infusion lumen extending longitudinally through the tube, at least one infusion lumen outlet generally adjacent the distal end of the catheter tube, and means adjacent the proximal end of the catheter tube for connecting a source of cardioplegia solution to the catheter; and

an inflatable balloon on the catheter tube generally adjacent the distal end of the catheter tube proximally of the infusion lumen outlet;

the inflatable balloon having a plurality of outwardly-facing, spaced-apart, segmented, annular ribs or lands for engaging the coronary sinus, each segmented annular rib or land comprising a plurality of solid, raised rib portions separated by non-raised portions extending annularly around the periphery of the balloon in alternating fashion, the raised rib portions of adjacent ribs or lands are staggered such that the raised rib portions of one rib or land are generally longitudinally aligned with the non-raised portions of the adjacent rib or land; and

a stylet removably received in the infusion lumen of the catheter.

57. A coronary sinus catheter assembly according to claim 56 wherein the raised rib portions are generally elongate having a direction of elongation extending generally circumferentially along the balloon.

58. A coronary sinus catheter assembly according to claim 57 wherein the raised rib portions have a length along their direction of elongation longer than the distance between adjacent raised rib portions along the non-raised portion separating the adjacent raised rib portions.

59. A coronary sinus catheter assembly according to claim 58 wherein the raised rib portions of one segmented rib or land each have a length along their direction of elongation generally equal to the other raised rib portions of that segmented rib or land.

60. A coronary sinus catheter assembly according to claim 59 wherein the non-raised portions of one segmented rib or land each define a distance between adjacent raised rib portions generally equal to the distance between raised rib portions defined by the other non-raised portions of that segmented rib or land.

61. A coronary sinus catheter assembly according to claim 60 wherein the catheter tube further defines a pressure lumen having lumen outlet generally adjacent the distal end of the catheter tube.

62. A coronary sinus catheter assembly according to claim 61 wherein the balloon and rib portions are integrally formed of elastomeric material having a Shore A hardness of between approximately 20 and 35.

63. A coronary sinus catheter assembly according to claim 61 wherein the raised rib portions have a generally asymmetrical profile along the longitudinal direction of the catheter, the raised rib portions having an upper surface sloping smoothly and gradually in the distal direction to the surface of the balloon, and a proximal surface extending from the upper surface more steeply to the surface of the balloon than the upper surface slopes to the surface of the balloon.

64. A coronary sinus catheter assembly according to claim 56 wherein the catheter tube further defines a pressure lumen having lumen outlet generally adjacent the distal end of the catheter tube.

65. A coronary sinus catheter assembly according to claim 56 wherein the balloon and rib portions are integrally formed of elastomeric material having a Shore A hardness of between approximately 20 and 35.

66. A coronary sinus catheter assembly according to claim 65 wherein the balloon and rib portions are integrally formed of silicone material.

67. A coronary sinus catheter assembly according to claim 66 wherein the raised rib portions have a generally asymmetrical profile along the longitudinal direction of the catheter, the raised rib portions having an upper surface sloping smoothly and gradually in the distal direction to the surface of the balloon, and a proximal surface extending from the upper surface more steeply to the surface of the balloon than the upper surface slopes to the surface of the balloon.

68. A coronary sinus catheter assembly according to claim 56 wherein the balloon and rib portions are integrally formed of silicone material.

69. A coronary sinus catheter assembly according to claim 56 wherein the raised rib portions have a generally asymmetrical profile along the longitudinal direction of the catheter, the raised rib portions having an upper surface sloping smoothly and gradually in the distal direction to the surface of the balloon, and a proximal surface extending from the upper surface more steeply to the surface of the balloon than the upper surface slopes to the surface of the balloon.

70. A coronary sinus catheter assembly according to claim 69 wherein the plurality of segmented ribs or lands comprises three to seven segmented ribs or lands.

71. A coronary sinus catheter assembly according to claim 70 wherein each segmented rib or land has the same number of raised rib portions and non-raised portions as the other ribs or lands.

72. A coronary sinus catheter assembly according to claim 56 wherein the plurality of segmented ribs or lands comprises three to seven segmented ribs or lands.

73. A coronary sinus catheter assembly according to claim 56 wherein each segmented rib or land has the same number of raised rib portions and non-raised portions as the other ribs or lands.

74. A coronary sinus catheter assembly according to claim 56 wherein the balloon comprises a molded balloon having two tubular extensions that are glued to the catheter tube to mount the balloon on the catheter tube.

75. A coronary sinus catheter assembly for the retrograde infusion of cardioplegia solution into the coronary sinus of a patient'"'"'s heart, the catheter assembly comprising:

a catheter comprising;

a flexible, elongate catheter tube having proximal and distal ends and an outer diameter, and including at least an infusion lumen extending longitudinally through the tube, at least one infusion lumen outlet generally adjacent the distal end of the catheter tube, and means adjacent the proximal end of the catheter tube for connecting a source of cardioplegia solution to the catheter; and

an inflatable balloon on the catheter tube generally adjacent the distal end of the catheter tube proximally of the infusion lumen outlet, the inflatable balloon being expandable as the balloon is inflated from an un-inflated diameter, generally equal to the outer diameter of the catheter tube for introducing the catheter into the coronary sinus, to an inflated diameter, substantially greater than the outer diameter of the catheter tube for securing the distal end of the catheter in the coronary sinus;

the inflatable balloon having a plurality of outwardly-facing, spaced-apart, segmented, annular ribs or lands for engaging the coronary sinus, each segmented annular rib or land comprising a plurality of solid, raised, generally elongate rib portions separated by non-raised portions extending annularly around the periphery of the balloon in alternating fashion, the raised rib portions of adjacent ribs or lands being staggered such that the raised rib portions of one rib or land are generally longitudinally aligned with the non-raised portions of the adjacent rib or land; and

a stylet removably received in the infusion lumen of the catheter.

76. A coronary sinus catheter assembly according to claim 75 wherein the raised rib portions have a generally asymmetrical profile along the longitudinal direction of the catheter, the raised rib portions having an upper surface sloping smoothly and gradually in the distal direction to the surface of the balloon, and a proximal surface extending from the upper surface more steeply to the surface of the balloon than the upper surface slopes to the surface of the balloon.

77. A coronary sinus catheter assembly for the retrograde infusion of cardioplegia solution into the coronary sinus of a patient'"'"'s heart, the catheter assembly comprising:

a catheter comprising;

a flexible, elongate catheter tube having proximal and distal ends and an outer diameter, and including at least an infusion lumen extending longitudinally through the tube, at least one infusion lumen outlet generally adjacent the distal end of the catheter tube, and means adjacent the proximal end of the catheter tube for connecting a source of cardioplegia solution to the catheter; and

an inflatable balloon on the catheter tube generally adjacent the distal end of the catheter tube proximally of the infusion lumen outlet, the inflatable balloon being expandable as the balloon is inflated from an un-inflated diameter, generally equal to the outer diameter of the catheter tube for introducing the catheter into the coronary sinus, to an inflated diameter, substantially greater than the outer diameter of the catheter tube for securing the distal end of the catheter in the coronary sinus;

the inflatable balloon having a plurality of outwardly-facing, spaced-apart, segmented, annular ribs or lands for engaging the coronary sinus, each segmented annular rib or land comprising a plurality of solid, raised, generally elongate rib portions separated by non-raised portions extending annularly around the periphery of the balloon in alternating fashion; and

a stylet removably received in the infusion lumen of the catheter;

the balloon comprising a molded balloon having two tubular extensions that are glued to the catheter tube to mount the balloon on the catheter tube; and

the tubular extensions including annular ribs extending radially inwardly adjacent the expandable portion of the balloon to provide an even glue line adjacent the expandable portion of the balloon.

78. A coronary sinus catheter assembly according to claim 77 wherein the raised rib portions of adjacent ribs or lands are staggered such that the raised rib portions of one rib or land are generally longitudinally aligned with the non-raised portions of the adjacent rib or land.

79. A cardiovascular catheter comprising:

a flexible, elongate catheter tube having proximal and distal ends and an outer diameter, and including at least an infusion lumen extending longitudinally through the tube, at least one infusion lumen outlet generally adjacent the distal end of the catheter tube, and means adjacent the proximal end of the catheter tube for connecting a source of fluid to the catheter; and

an inflatable balloon on the catheter tube generally adjacent the distal end of the catheter tube proximally of the infusion lumen outlet;

the inflatable balloon having a plurality of outwardly-facing, spaced-apart, segmented, annular ribs or lands for engaging the internal walls of a blood vessel, each segmented annular rib or land comprising a plurality of solid, raised, generally elongate rib portions separated by non-raised portions extending circumferentially around the periphery of the balloon in alternating fashion, the raised rib portions having a direction of elongation extending generally circumferentially along the balloon, the balloon, including the ribs or lands, being integrally molded of generally uniform elastomeric material.

80. A cardiovascular catheter according to claim 79 wherein each raised rib portion has a length along its direction of elongation longer than the distance between adjacent raised rib portions along the non-raised portion separating the adjacent raised rib portions.

81. A cardiovascular catheter according to claim 80 further comprising a pressure sensing lumen within the catheter tube separate from the infusion lumen.

82. A cardiovascular catheter according to claim 80 further comprising two separate lumens in addition to the infusion lumen, one of the separate lumens comprising a balloon inflation lumen in fluid communication with the balloon to inflate and deflate the balloon.

83. A cardiovascular catheter according to claim 82 wherein the raised rib portions of adjacent ribs or lands are staggered such that the raised rib portions of one rib or land are generally longitudinally aligned with the non-raised portions of the adjacent rib or land.

84. A cardiovascular catheter according to claim 83 wherein the raised rib portions have a generally asymmetrical profile along the longitudinal direction of the catheter, the raised rib portions having an upper surface sloping smoothly and gradually in the distal direction to the surface of the balloon, and a proximal surface extending from the upper surface more steeply to the surface of the balloon than the upper surface slopes to the surface of the balloon.

85. A cardiovascular catheter comprising:

a flexible, elongate catheter tube having proximal and distal ends and an outer diameter, and including at least an infusion lumen extending longitudinally through the tube, at least one infusion lumen outlet generally adjacent the distal end of the catheter tube, and means adjacent the proximal end of the catheter tube for connecting a source of fluid to the catheter; and

an inflatable balloon on the catheter tube generally adjacent the distal end of the catheter tube proximally of the infusion lumen outlet, the inflatable balloon having a plurality of outwardly-facing, spaced-apart, segmented, annular ribs or lands for engaging the internal walls of a blood vessel, each segmented annular rib or land comprising a plurality of solid, raised rib portions separated by non-raised portions extending annularly around the periphery of the balloon in alternating fashion;

the balloon comprising an expandable portion and two tubular extensions extending from opposite ends of the expandable portion, the tubular extensions being glued to the catheter tube to mount the expandable portion of the balloon on the catheter tube, the tubular extensions including annular ribs extending radially inwardly adjacent the expandable portion of the balloon to provide an even glue line adjacent the expandable portion of the balloon.