Introducer for accessing the coronary sinus of a heart

• US 7,462,184 B2
• Filed: 05/06/2002
• Issued: 12/09/2008
• Est. Priority Date: 05/06/2002
• Status: Expired due to Term

• Current Assignee: Pressure Products Medical Supplies Incorporated
• Original Assignee: Pressure Products Medical Supplies Incorporated
• Inventors: Kurth, Paul, Worley, Seth J.
• Primary Examiner(s): Woo; Julian W
• Application Number:
  US10/139,551
• Publication Number:
  US 20030208141A1
• Time in Patent Office: 2,409 Days
• Field of Search: 606/191, 606/194, 606/129, 606/108, 606/192, 604/264, 604/523, 604/525, 604/528, 604/532
• US Class Current: 606/129
• CPC Class Codes: A61M 2210/125 Heart
• CPC Class Codes: A61M 25/0041 pre-formed, e.g. specially adapted to fit with the anatomy of body channels urethral catheters A61F2/04

Abstract

The invention is defined as a precurved coronary sinus guiding introducer for use in a cardiomyopathic heart comprising a flexible elongated member with a proximal and distal end. The elongated member comprises a generally straight, proximal portion and a precurved distal portion. In one embodiment the proximal portion and distal portion are formed to lie is a common plane. In another embodiment the portions are angulated with respect to each other in different planes. The precurved distal portion comprises at least one curved subportion and at least one curved or straight subportion. The precurved distal subportion curves through a generally circular arc away and is defined by a chord of predetermined length. The precurved distal subportion has a predetermined height above the chord. The curved or straight subportion is the distal section of the precurved distal portion.

Claims

1. A precurved coronary sinus guiding introducer for use in a dilated cardiomyopathic heart comprising:

a flexible elongated member with a proximal and distal end, wherein the elongated member comprises a generally straight, proximal portion and a precurved distal portion, the proximal portion and distal portion formed to lie is a common plane,

wherein the precurved distal portion comprises at least one curved proximal subportion and at least one curved or straight distal subportion, the precurved distal portion curving through a generally circular arc defined by a chord of predetermined length, and wherein the precurved distal portion has a predetermined height above the chord, and the curved or straight distal subportion being the distal most section of the precurved distal portion,

wherein the distal most section of the precurved distal portion is generally oriented in a direction parallel to the straight, proximal portion;

wherein the chord of the precurved distal portion has a length measured on a perpendicular to a longitudinal axis of the proximal portion between the beginning of the precurved distal portion where it meets the longitudinal axis of the proximal portion and a longitudinal axis of the opposing end of the precurved distal portion drawn parallel to the longitudinal axis of the proximal portion, and wherein the chord has the predetermined length of approximately 3.5 to 7 inches;

wherein the predetermined height above the chord is approximately 1.5 inches to 4.0 inches, and

wherein the curved or straight distal subportion is approximately 0.5 to 4.5 inches in length; and

wherein the precurved distal portion has a minimal length of approximately 7.2 inches such that the distal end of the elongate member readily accesses the coronary sinus ostium in the dilated cardiomyopathic heart.

2. The coronary sinus guiding introducer of claim 1 further comprising a lumen extending through the member from the proximal to the distal end.

3. The coronary sinus guiding introducer of claim 1 wherein the chord has the predetermined length of approximately 4.6-7 inches.

4. The coronary sinus guiding introducer of claim 1 wherein the predetermined height above the chord is at least approximately 2.65 inches and a height from the distal tip to the precurved distal portion of at least 1.5 inches.

5. The coronary sinus guiding introducer of claim 1 wherein the curved or straight distal subportion is approximately 0.7-1.6 inches in length.

6. The introducer of claim 1 where the precurved distal portion includes one or more straight subportions.

7. The introducer of claim 6 where the precurved distal portion includes more than one arc.

8. The introducer of claim 6 where one of the straight subportions comprises a distal most straight subportion.

9. The introducer of claim 1 where the precurved distal subportion is comprised of two curved portions and two straight portions in alternating sequence with a distal one of the two straight portions leading to the distal end.

10. The introducer of claim 9 where the two curved portions comprise a proximal curved portion having a radius of curvature of approximately 2.0±

0.25 to 2.85±

0.25 inches and a distal curved portion having a radius of curvature of approximately 1.25±

0.25 to 2.0±

0.25 inches.

11. The introducer of claim 1 where the precurved distal subportion is further comprised of three curved portions and the curved or straight portion leading to the distal end, the three curved portions each having a different radius of curvature with the portion having the largest radius of curvature being between the other two curved portions.

12. The coronary sinus guiding introducer of claim 1 where the elongated member is separable.

13. The coronary sinus guiding introducer of claim 1 further comprising a sidearm catheter coupled to the elongated member.

14. The coronary sinus guiding introducer of claim 11 further comprising a radioopaque marker on the distal most section of the precurved distal portion.

15. The coronary sinus guiding introducer of claim 1 where the curved or straight distal subportion is parallel to the proximal portion.

16. A coronary sinus guiding introducer for use in a dilated cardiomyopathic heart, the introducer having a precurved shape comprising:

a flexible elongated member with a proximal and distal end, wherein the elongated member comprises a generally straight, proximal portion and a precurved distal portion, the proximal portion and distal portion formed to lie in a common plane,

wherein the precurved distal portion comprises at least one curved proximal subportion and at least one curved or straight distal subportion, the precurved distal portion curving through a generally circular arc defined by a chord of predetermined length and wherein the precurved distal portion has a predetermined height from the chord, and the curved or straight distal subportion being the distal most section of the precurved distal portion which is generally oriented in a direction parallel to the straight, proximal portion; and

wherein the chord of the precurved distal portion has a length measured on a perpendicular to a longitudinal axis of the proximal portion between the beginning of the precurved distal portion where it meets the longitudinal axis of the proximal portion and a longitudinal axis of the opposing end of the precurved distal portion drawn parallel to the longitudinal axis of the proximal portion, and wherein the chord has a predetermined length of approximately 4.6 to 7 inches and height from the chord is approximately 2.5 to 4.0 inches, and wherein the precurved distal portion has a length of approximately 7.2 to 16 inches such that the distal end of the elongate member readily accesses the coronary sinus ostium in the dilated cardiomyopathic heart.

17. The coronary sinus guiding introducer of claim 16 where the elongated member is separable.

18. The coronary sinus guiding introducer of claim 16 further comprising a sidearm catheter coupled to the elongated member.

19. The coronary sinus guiding introducer of claim 16 further comprising a radioopaque marker on the distal most section of the precurved distal portion.

20. The coronary sinus guiding introducer of claim 16 where the distal most section of the precurved distal portion is parallel to the proximal portion.

21. A precurved coronary sinus guiding introducer with a distal end for use in a dilated cardiomyopathic heart comprising:

a proximal portion which is biased to be generally straight; and

a precurved distal portion biased to curve through an arc defined by a chord of predetermined length and wherein the precurved distal portion has a predetermined height above the chord, the chord of the precurved distal portion has a length measured on a perpendicular to a longitudinal axis of the proximal portion between the beginning of the precurved distal portion where it meets the longitudinal axis of the proximal portion and a longitudinal axis of the opposing end of the precurved distal portion drawn parallel to the longitudinal axis of the proximal portion, and wherein the chord has the predetermined minimal length of approximately 3.5 inches, the predetermined minimal height above the chord is approximately 1.5 inches, and the precurved distal portion has a minimal length of approximately 6 inches, such that the distal end of the precurved distal portion of the introducer is generally oriented in a direction parallel to the straight, proximal portion and readily accesses the coronary sinus ostium in the dilated cardiomyopathic heart.

22. The introducer of claim 21 where the precurved distal portion includes one or more straight subportions

23. The introducer of claim 21 where the precurved distal portion includes more than one arc.

24. The introducer of claim 22 where one of the straight subportions comprises a distal most straight subportion.

25. The coronary sinus guiding introducer of claim 21 where the proximal portion and precurved distal portion are separable.

26. The coronary sinus guiding introducer of claim 21 further comprising a sidearm catheter coupled to the proximal portion.

27. The coronary sinus guiding introducer of claim 21 further comprising a radioopaque marker on the distal end of the precurved distal portion.

28. The coronary sinus guiding introducer of claim 21 where the distal end of the precurved distal portion is parallel to the proximal portion.

29. A precurved coronary sinus guiding introducer with a distal end for use in a dilated cardiomyopathic heart comprising:

a flexible elongated member with a proximal and distal end, wherein the elongated member comprises

a proximal portion biased to be generally straight, and

a precurved distal portion biased to curve through an arc defined by a chord of predetermined length and wherein the precurved distal portion has a predetermined height above the chord, the chord of the precurved distal portion has a length measured on a perpendicular to a longitudinal axis of the proximal portion between the beginning of the precurved distal portion where it meets the longitudinal axis of the proximal portion and a longitudinal axis of the opposing end of the precurved distal portion drawn parallel to the longitudinal axis of the proximal portion, and wherein the chord has the predetermined length of approximately 3.5 to 7 inches, the predetermined height above the chord is approximately 1.5 inches to 4.0 inches such that the distal end of the introducer is generally oriented in a direction parallel to the straight, proximal portion and readily accesses the coronary sinus ostium in the dilated cardiomyopathic heart.

30. The introducer of claim 29 where the precurved distal portion includes one or more straight subportions.

31. The introducer of claim 30 where the precurved distal portion includes more than one arc.

32. The introducer of claim 31 where one of the straight subportions comprises a distal most straight subportion.

33. The introducer of claim 29 where the precurved distal portion has a length of approximately 5-16 inches.

34. The coronary sinus guiding introducer of claim 29 where the elongated member is separable.

35. The coronary sinus guiding introducer of claim 29 further comprising a sidearm catheter coupled to the elongated member.

36. The coronary sinus guiding introducer of claim 29 further comprising a radioopaque marker on the distal end of the introducer.

37. The coronary sinus guiding introducer of claim 29 where the distal end of the introducer is parallel to the proximal portion.

38. A precurved coronary sinus guiding introducer for use in a dilated cardiomyopathic heart comprising:

a flexible elongated member with a proximal and distal end, wherein the elongated member comprises a generally straight, proximal portion which assumes a general direction and a precurved distal portion, the proximal portion and distal portion formed to lie is a common plane,

wherein the precurved distal portion comprises at least one curved proximal subportion and at least one curved or straight distal subportion, the precurved distal portion curving through a generally circular arc defined by a chord of predetermined length and wherein the precurved distal portion has a predetermined height above the chord, and the curved or straight distal subportion being the distal most section of the precurved distal portion,

wherein the chord of the precurved distal portion has a length measured on a perpendicular to a longitudinal axis of the proximal portion between the beginning of the precurved distal portion where it meets the longitudinal axis of the proximal portion and a longitudinal axis of the opposing end of the precurved distal portion drawn parallel to the longitudinal axis of the proximal portion, and wherein the chord has the predetermined length of approximately 3.5 to 7 inches,

wherein the predetermined height above the chord is approximately 1.5 inches to 4.0 inches, and

wherein the curved or straight distal subportion is approximately 0.5 to 4.5 inches in length and is oriented to extend in a direction approximating the general direction of the proximal portion; and

wherein the precurved distal portion has a minimal length of approximately 7.2 inches such that the distal end of the elongate member readily accesses the coronary sinus ostium in the dilated cardiomyopathic heart.

39. The coronary sinus guiding introducer of claim 38 further comprising a lumen extending through the member from the proximal to the distal end.

40. The coronary sinus guiding introducer of claim 38 wherein the chord has the predetermined length of approximately 4.6-7 inches.

41. The coronary sinus guiding introducer of claim 38 wherein the predetermined height above the chord is at least approximately 2.65 inches and a height from the distal tip to the maximum extending portion of the precurved distal portion is at least 1.5 inches.

42. The coronary sinus guiding introducer of claim 38 wherein the curved or straight distal subportion is approximately 0.7-1.6 inches in length.

43. The introducer of claim 38 where the precurved distal portion includes one or more straight subportions.

44. The introducer of claim 43 where one of the straight subportions comprises a distal most straight subportion.

45. The coronary sinus guiding introducer of claim 38 where the elongated member is separable.

46. The coronary sinus guiding introducer of claim 38 further comprising a sidearm catheter coupled to the elongated member.

47. The coronary sinus guiding introducer of claim 38 further comprising a radioopaque marker on the distal most section of the precurved distal portion.

48. The coronary sinus guiding introducer of claim 38 where the curved or straight distal subportion is parallel to the proximal.

49. The introducer of claim 38 where the precurved distal portion includes more than one arc.

50. The introducer of claim 38 where the precurved distal subportion is comprised of two curved portions and two straight portions in alternating sequence with a distal one of the two straight portions leading to the distal end.

51. The introducer of claim 50 where the two curved portions comprise a proximal curved portion having a radius of curvature of 2.0±

0.25 to 2.85±

0.25 inches and a distal curved portion having a radius of curvature of 1.25±

0.25 to 2.0±

0.25 inches.

52. The introducer of claim 38 where the precurved distal subportion is further comprised of three curved portions and the curved or straight portion leading to the distal end, the three curved portions each having a different radius of curvature with the portion having the largest radius of curvature being between the other two curved portions.

53. A coronary sinus guiding introducer for use in a dilated cardiomyopathic heart, the introducer having a precurved shape comprising:

a flexible elongated member with a proximal and distal end, wherein the elongated member comprises a generally straight, proximal portion which assumes a general direction and a precurved distal portion, the proximal portion and distal portion formed to lie in a common plane,

wherein the precurved distal portion comprises at least one curved proximal subportion and at least one curved or straight distal subportion, the precurved distal portion curving through a generally circular arc defined by a chord of predetermined length and wherein the precurved distal portion has a predetermined height from the chord, and the curved or straight distal subportion being the distal most section of the precurved distal portion and being oriented to extend in a direction approximating the general direction of the proximal portion; and

wherein the chord of the precurved distal portion has a length measured on a perpendicular to a longitudinal axis of the proximal portion between the beginning of the precurved distal portion where it meets the longitudinal axis of the proximal portion and a longitudinal axis of the opposing end of the precurved distal portion drawn parallel to the longitudinal axis of the proximal portion. and wherein the chord has a predetermined length of approximately 4.6 to 7 inches and height from the chord is approximately 2.5 to 4.0 inches, and wherein the precurved distal portion has a length of approximately 7.2 to 16 inches such that the distal end of the elongate member readily accesses the coronary sinus ostium in the dilated cardiomyopathic heart.

54. The coronary sinus guiding introducer of claim 53 where the elongated member is separable.

55. The coronary sinus guiding introducer of claim 53 further comprising a sidearm catheter coupled to the elongated member.

56. The coronary sinus guiding introducer of claim 53 further comprising a radioopaque marker on the distal most section of the precurved distal portion.

57. The coronary sinus guiding introducer of claim 53 where the distal most section of the precurved distal portion is parallel to the proximal portion.

58. A precurved coronary sinus guiding introducer with a distal end for use in a dilated cardiomyopathic heart comprising:

a proximal portion which is biased to be generally straight and assumes a general direction, and

a precurved distal portion biased to curve through an arc defined by a chord of predetermined length and wherein the precurved distal portion has a predetermined height above the chord, the chord of the precurved distal portion has a length measured on a perpendicular to a longitudinal axis of the proximal portion between the beginning of the precurved distal portion where it meets the longitudinal axis of the proximal portion and a longitudinal axis of the opposing end of the precurved distal portion drawn parallel to the longitudinal axis of the proximal portion. and wherein the chord has the predetermined minimal length of approximately 3.5 inches, the predetermined minimal height above the chord is approximately 1.5 inches, and the precurved distal portion has a minimal length of approximately 6 inches, such that the distal end of the precurved distal portion of the introducer is oriented to extend in a direction approximating the direction of the proximal portion and readily accesses the coronary sinus ostium in the dilated cardiomyopathic heart.

59. The introducer of claim 58 where the precurved distal portion includes one or more straight subportions.

60. The introducer of claim 59 where the precurved distal portion includes more than one arc.

61. The introducer of claim 59 where one of the straight subportions comprises a distal most straight subportion.

62. The coronary sinus guiding introducer of claim 58 where the proximal portion and precurved distal portion are separable.

63. The coronary sinus guiding introducer of claim 58 further comprising a sidearm catheter coupled to the proximal portion.

64. The coronary sinus guiding introducer of claim 58 further comprising a radioopaque marker on the distal end of the precurved distal portion.

65. The coronary sinus guiding introducer of claim 58 where the distal end of the precurved distal portion is parallel to the proximal portion.

66. A precurved coronary sinus guiding introducer with a distal end for use in a dilated cardiomyopathic heart comprising:

a flexible elongated member with a proximal and distal end, wherein the elongated member comprises

a proximal portion biased to be generally straight and which assumes a general direction, and

a precurved distal portion biased to curve through an arc defined by a chord of predetermined length and wherein the precurved distal portion has a predetermined height above the chord, the chord of the precurved distal portion has a length measured on a perpendicular to a longitudinal axis of the proximal portion between the beginning of the precurved distal portion where it meets the longitudinal axis of the proximal portion and a longitudinal axis of the opposing end of the precurved distal portion drawn parallel to the longitudinal axis of the proximal portion, and wherein the chord has the predetermined length of approximately 3.5 to 7 inches, the predetermined height above the chord is approximately 1.5 inches to 4.0 inches such that the distal end of the introducer is oriented to extend in a direction approximating the general direction of the proximal portion and readily accesses the coronary sinus ostium in the dilated cardiomyopathic heart.

67. The introducer of claim 66 where the precurved distal portion includes one or more straight subportions.

68. The introducer of claim 67 where the precurved distal portion includes more than one arc.

69. The introducer of claim 67 where one of the straight subportions comprises a distal most straight subportion.

70. The introducer of claim 66 where the precurved distal portion has a length of approximately 5-16 inches.

71. The coronary sinus guiding introducer of claim 66 where the elongated member is separable.

72. The coronary sinus guiding introducer of claim 66 further comprising a sidearm catheter coupled to the elongated member.

73. The coronary sinus guiding introducer of claim 66 further comprising a radioopaque marker on the distal end of the introducer

74. The coronary sinus guiding introducer of claim 66 where the distal end of the introducer is parallel to the proximal portion.

75. A precurved coronary sinus guiding introducer for use in a dilated cardiomyopathic heart comprising:

a flexible elongated member with a proximal and distal end, wherein the elongated member comprises a generally straight, proximal portion and a precurved distal portion, the proximal portion and precurved distal portion formed to lie is a common plane, wherein the precurved distal portion comprises an arc or a combination of arcs and/or straight segments, the precurved distal portion defined by a chord of predetermined length and a predetermined height above the chord, the distal most section of the precurved distal portion being generally oriented in a direction parallel to the straight, proximal portion;

wherein the chord of the precurved distal portion has a length measured on a perpendicular to a longitudinal axis of the proximal portion between the beginning of the precurved distal portion where it meets the longitudinal axis of the proximal portion and a longitudinal axis of the opposing end of the precurved distal portion drawn parallel to the longitudinal axis of the proximal portion, and wherein the chord has the predetermined length of approximately 3.5to 7 inches,

wherein the predetermined height above the chord is approximately 1.5 inches to 4.0 inches, and

wherein the precurved distal portion has a minimal length of approximately 7.2inches such that the distal end of the elongate member readily accesses the coronary sinus ostium in the dilated cardiomyopathic heart.

76. The precurved coronary sinus guiding introducer of claim 75 where the distal most section of the precurved distal portion extends in a direction between 156°

to 227°

with respect to the proximal portion, where 180°

is parallel to the proximal portion.

77. A precurved coronary sinus guiding introducer for use in a dilated cardiomyopathic heart comprising:

a flexible elongated member with a proximal and distal end, wherein the elongated member comprises a generally straight, proximal portion and a precurved distal portion, the proximal portion and precurved distal portion formed to lie is a common plane, wherein the precurved distal portion comprises an arc or a combination of arcs and/or straight segments, the precurved distal portion defined by a chord of predetermined length and a predetermined height above the chord, the distal most section of the precurved distal portion being generally oriented in a direction parallel to the straight, proximal portion;

wherein the chord of the precurved distal portion has a length measured on a perpendicular to a longitudinal axis of the proximal portion between the beginning of the precurved distal portion where it meets the longitudinal axis of the proximal portion and a longitudinal axis of the opposing end of the precurved distal portion drawn parallel to the longitudinal axis of the proximal portion, and

wherein the chord has the predetermined length of approximately 3.5 to 7 inches,

wherein the predetermined height above the chord is approximately 1.5 inches to 4.0 inches, and

wherein the precurved distal portion has a minimal length of approximately 7.2 inches such that the distal end of the elongate member readily accesses the coronary sinus ostium in the dilated cardiomyopathic heart.

78. The precurved coronary sinus guiding introducer of claim 77 where the distal most section of the precurved distal portion extends in a direction between 156°

to 227°

with respect to the proximal portion, where 180°

is parallel to the proximal portion.