Steerable guide wire for balloon dilatation procedure

• US 4,545,390 A
• Filed: 09/22/1982
• Issued: 10/08/1985
• Est. Priority Date: 09/22/1982
• Status: Expired due to Fees

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Leary, James J.
• Primary Examiner(s): Truluck, Dalton L.
• Application Number:
  US06/421,315
• Time in Patent Office: 1,112 Days
• Field of Search: 128/325, 128/344, 128/348.1, 128/656-658, 128/772, 604/95, 604/96, 604/170
• US Class Current: 600/462
• CPC Class Codes: A61B 2017/22001 Angioplasty, e.g. PCTA
• CPC Class Codes: A61M 2025/09166 having radio-opaque features
• CPC Class Codes: A61M 2025/09175 having specific characteristics at the distal tip
• CPC Class Codes: A61M 25/0108 using radio-opaque or ultrasound markers
• CPC Class Codes: A61M 25/09033 with fixed mandrils, e.g. mandrils fixed to tip; Tensionable wires

Abstract

A guide wire is provided to guide a very small diameter catheter, such as a coronary dilatation catheter used in coronary angioplasty techniques. The guide wire itself is of very small diameter, (under 0.020") yet is steerable and may be visualized fluoroscopically. The major portion of the guide wire is a small diameter flexible rod. The distal region of the rod is tapered. The tapered portion is surrounded by a helically wound spring which is brazed at its proximal and distal ends, to the base and tip, respectively, of the tapered region of the rod. A shorter segment of the spring extends beyond the distal end of the rod and serves as a highly flexible bumper to assure that the distal tip of the guide wire will not cause traumatic injury to the blood vessel. The distal region of the guide can be bent manually by the surgeon to a curved shape which it will tend to assume when relaxed. The distal region is flexible and can bend from the set curve to follow the contour of the blood vessel. The distal end of the wire can be steered by manipulation and rotation of the proximal end of the guide. At least the spring portion of the guide wire is formed from a material having a high degree of radiopacity to facilitate its fluoroscopic observation. Also disclosed is a combination of such a spring guide with a coronary dilatation catheter.

Claims

1. A steerable small diameter guide wire comprising:

a main wire having a tapered distal region;

a helically wound spring at the distal region of the main wire, the tapered region of the main wire being received within the spring, the proximal end of the spring being secured to the main wire at a proximal connection adjacent to the region where the main wire begins to taper;

the distal end of the main wire terminating short of the distal end of the spring and being secured to the spring at a distal connection;

the spring having a relatively short portion which extends distally beyond the distal end of the main wire, the distally extending short portion being highly flexible and terminating in a smoothly surfaced rounded tip;

each of the main wire and the spring having an outer diameter which is no greater than about 0.020 inches, the diameter of the spring being not substantially greater than the diameter of the main wire;

the guide wire having a distal region which is adapted to be bent to a set curved configuration and to retain that set curve when the distal region of the guide wire is relaxed, said distal region of the guide wire being sufficiently flexible so as to adapt to and follow the contours of a patient'"'"'s blood vessel;

said guide wire having means sufficiently torsionally rigid along its length for transmitting to the distal end of the guide wire substantially all of the angular rotation applied to the proximal end of the guide wire thereby enabling the curved distal end of the guide wire to be controllably directed to selected branches of a patient'"'"'s vascular system.

2. A guide wire as defined in claim 1 wherein at least the spring is formed from a material having a high radiopacity.

3. A guide wire as defined in claim 2 wherein the spring is formed from an alloy which includes approximately 92% platinum and 8% tungsten.

4. A steerable small diameter guide wire as defined in claim 1 wherein the distal region of the main wire is tapered progressively toward the distal end of the wire and wherein said tapered region of the main wire extends smoothly and uniformly from the more proximal portions of the main wire and defining a smooth transition from the untapered to the tapered portion.

5. A steerable small diameter guide wire as defined in claim 1 wherein the outer diameter of each of the spring and the main wire are substantially the same.

6. A guide wire as defined in claim 1 in which only a minor portion of the overall length of the guide wire comprises the spring.

7. A guide wire as defined in claim 1 further comprising:

said guide wire being of a length of the order of 175 centimeters;

the spring and tapered region of the main wire extending over the most distal approximately 20 centimeters of the guide wire;

the distal extension of the spring being approximately one centimeter long.

8. A small diameter guide wire as defined in claim 1 further comprising:

said tapered region of the main wire beginning its taper at a location which is intermediate the proximal and distal ends of the spring.

9. A set for introducing a balloon dilatation catheter and for performing a balloon dilatation in a blood vessel comprising:

a guide wire as defined in claim 1;

a balloon dilatation catheter having a main lumen which is receptive to the guide wire, said main lumen being open at the distal end of the catheter.

10. A set as defined in claim 9 wherein the main lumen in the balloon dilatation catheter is larger in cross-section than the guide wire whereby a flow passage may be maintained within the balloon catheter for infusion of liquids and pressure measurements without requiring removal of the guide wire.

11. A set as defined in claim 10 wherein the main lumen has a different cross-sectional shape than that of the guide wire.

12. A set as defined in claim 11 wherein the guide wire is circular in cross-section and the main lumen of the catheter is D-shaped in cross-section.

13. A set as defined in claim 9 wherein the outer diameter of the dilatation catheter is not greater than of the order of 0.050 inches.

14. A set as defined in claim 10 wherein said guide wire is circular in cross-section and wherein said main lumen is non-circular in cross-section.

15. A set as defined in claim 10 wherein the cross-section defined by the guide wire is not greater than about 50% of the cross-sectional area of the main lumen in the catheter.

16. A set of a small diameter catheter and steerable guide wire for use therewith comprising:

a guide wire as defined in claim 1, and

a catheter having a lumen receptive to the guide wire, the lumen being open at the distal end of the catheter, said catheter having an outer diameter not greater than of the order of 0.050 inches.

17. A guide wire as defined in claim 1 further comprising:

the taper at the distal region of the main wire being continuous.

18. A guide wire as defined in claim 1 wherein said torsionally rigid means comprises said main wire being formed from a solid rod.

19. A guide wire as defined in claim 1 wherein said torsionally rigid means comprises said main wire being formed from a solid walled tube.

20. A guide wire as defined in claim 1 wherein the spring is formed from an alloy which includes approximately 92 percent platinum and 8 percent tungsten.

51. A guide wire as defined in claim 5 wherein the spring is formed from an alloy which includes a major proportion of platinum.

55. A guide wire as defined in claim 51 wherein the distal end of the guide wire includes a bendable safety wire within the spring, the safety wire being adapted to be bent to and retain said set curve.

21. A small diameter steerable guide wire comprising:

a main wire having a distal region;

a helically wound spring connected to the main wire at the distal region and receiving the distal region therein;

said guide wire being constructed and arranged so that the portion thereof located proximally of the distal region of the main wire is of substantially uniform flexibility along its length;

that portion of the guide wire which includes the distal region of the main wire and that portion of the helically wound spring which surrounds the distal region being of increasing flexibility in a distal direction

the spring having a distal extension which extends beyond the distal end of the main wire, the distal extension being of substantially uniform flexibility along its length, said distal extension being the most flexible of all of said portions of the guide wire;

the main wire and spring having substantially the same outer diameter, said diameter being no greater than about 0.020 inches;

that portion of the guide wire which includes the distal region of the main wire being adapted to be bent to a set curved configuration but being sufficiently flexible from said set curved configuration so as to adapt to and follow the contours of a patient'"'"'s blood vessel;

the guide wire having means sufficiently torsionally rigid along its length for transmitting to the distal end of the guide wire substantially all of the angular rotation applied to the proximal end of the guide wire thereby enabling said guide wire with a set curved configuration at its distal region to be controllably directed to selected branches of a patient'"'"'s vascular system.

22. A guide wire as defined in claim 21 further comprising:

the distal region of the main wire being constructed so that it is more flexible at its distal end than at its proximal end.

23. A guide wire as defined in claim 22 wherein the distal region of the main wire is tapered in the distal direction.

24. A guide wire as defined in claim 23 wherein the taper is substantially continuous.

25. A set for introducing a balloon dilatation catheter and for performing a balloon dilatation in a blood vessel comprising:

a guide wire as defined in claim 21; and

a balloon dilatation catheter having a main lumen which is receptive to the guide wire, said main lumen being open at the distal end of the catheter.

26. A set as defined in claim 25 wherein the main lumen in the balloon dilatation catheter is larger in cross-section than the guide wire whereby a flow passage may be maintained within the balloon catheter for infusion of liquids and pressure measurements without requiring removal of the guide wire.

27. A set as defined in claim 26 wherein the main lumen has a different cross-sectional shape than that of the guide wire.

28. A set as defined in claim 27 wherein the guide wire is circular is cross-section and the main lumen of the catheter is D-shaped in cross-section.

29. A set as defined in claim 25 wherein the outer diameter of the dilatation catheter is not greater than of the order 0.050 inches.

30. A set as defined in claim 26 wherein said guide wire is circular in cross-section and wherein said main lumen is non circular in cross-section.

31. A set as defined in claim 26 wherein the cross-section defined by the guide wire is not greater than about 50 percent of the cross-sectional area of the main lumen in the catheter.

32. A small diameter steerable guide wire having a proximal end and a distal end comprising:

a main wire having a distal region which is tapered toward the distal end of the wire;

a helically wound spring at the distal region of the main wire, the tapered portion of the main wire being received within the spring, the spring having a proximal end secured to the main wire at a proximal connection adjacent to the region where the main wire begins to taper;

the distal end of the main wire being secured to the spring at a location distal of said proximal connection;

each of said main wire and spring having an outer diameter which is no greater than about 0.020 inches, the diameter of the spring being not substantially greater than the diameter of the main wire;

the distal end of the guide wire being adapted to be bent to a set curved configuration and to retain that set curved configuration when relaxed, said distal end being sufficiently flexible so as to adapt to and follow the contours of a patient'"'"'s blood vessel;

the guide wire having means sufficiently torsionally rigid along its length for transmitting to the distal end of the guide wire substantially all of the angular rotation applied to the proximal end of the guide wire thereby enabling said guide wire with prebent distal end to be controllably directed to selected branches of a patient'"'"'s vascular system.

33. A small diameter steerable guide wire as defined in claim 32 wherein the outer diameter of each of the main wire and spring are substantially the same.

34. A small diameter steerable guide wire as defined in claim 32 wherein at least the spring is formed from a material having a high radiopacity.

35. A steerable small diameter guide wire as defined in claim 32 further comprising:

said guide wire being of a length of the order of 175 centimeters;

the spring and tapered portion extending over the most distal approximately 20 centimeters of the guide wire.

36. A set of a small diameter catheter and steerable guide wire for use therewith comprising:

a guide wire as defined in claim 32; and

a catheter having a lumen receptive to the guide wire, said catheter having an outer diameter not greater than of the order of 0.050 inches.

37. A set as defined in claim 36 wherein said catheter comprises a balloon dilatation catheter.

38. A set as defined in claim 37 wherein the catheter has a main lumen which is open at the distal end of the catheter, the main lumen being larger in cross-section than the guide wire whereby a flow passage may be maintained within the balloon catheter for infusion of liquids and pressure measurement without requiring removal of the guide wire.

39. A set as defined in claim 38 wherein the main lumen has a different cross-sectional shape than that of the guide wire.

40. A set as defined in claim 39 wherein the guide wire is circular in cross-section and the main lumen of the catheter is D-shaped in cross-section.

41. A set as defined in claim 39 wherein the guide wire is circular and the lumen is non-circular.

42. A set as defined in claim 38 wherein the cross-sectional area of the guide wire is not greater than 50% of the cross-sectional area of the lumen.

43. A guide wire as defined in claim 32 wherein the taper at the distal region of the main wire is continuous.

44. A guide wire as defined in claim 32 wherein the torsionally rigid means comprises said main wire being formed from a solid rod.

45. A guide wire as defined in claim 32 wherein said torsionally rigid means comprises said guide wire being formed from a solid walled tube.

46. A guide wire as defined in claim 32 wherein said torsionally rigid means comprises said main wire being formed from a solid rod.

47. A guide wire as defined in claim 32 wherein said torsionally rigid means comprises said main wire being formed from a solid walled tube.

48. A guide wire as defined in claim 32 wherein the distal end of guide wire includes a bendable safety wire in the spring, the safety wire being adapted to be bent to said set curved configuration.

49. A guide wire as defined in claim 32 further comprising a distal spring extension at the distal end of the spring, the extension extending distally beyond the distal end of the main wire.

50. A steerable small diameter guide wire having a proximal end and a distal end comprising:

a main wire having a proximal end and a distal region;

a helically wound spring connected to the distal region of the main wire, the length of the spring comprising a relatively short portion of the overall length of the guide wire and the main wire comprising the major portion of the overall length of the guide wire;

the spring being formed at least in part from a material having a high radiopacity;

each of said main wire and spring having a maximum diameter which does not exceed 0.020 inches;

the distal end of the guide wire being constructed to be bendable to a set curved configuration and to retain that set curve when relaxed, said bendable distal end being sufficiently flexible so as to adapt to and follow the contours of a patient'"'"'s blood vessel;

the guide wire having means sufficiently torsionally rigid along its length for transmitting to the distal end of the guide wire substantially all of the angular rotation applied to the proximal end of the guide wire thereby enabling the guide wire with prebent distal end to be controllably directed to selected branches of a patient'"'"'s vascular system.

52. A guide wire as defined in claim 50 wherein said torsionally rigid means comprises said main wire being formed from a solid rod.

53. A guide wire as defined in claim 50 wherein said torsionally rigid means comprises:

said main wire being formed from a solid walled tube.

54. A guide wire as defined in claim 50 wherein the outer diameter of each of the main wire and spring are substantially the same.

56. A guide wire as defined in claim 50 further comprising a distal spring extension at the distal end of the spring, the extension extending beyond the distal end of the main wire.

57. A set for introducing a balloon dilatation catheter and for performing a balloon dilatation in a blood vessel comprising:

a guide wire as defined in claim 50; and

a balloon dilatation catheter having a main lumen which is receptive to the guide wire, said main lumen being open at the distal end of the catheter.

58. A set as defined in claim 57 wherein the main lumen in the balloon dilatation catheter is larger in cross-section than the guide wire whereby a flow passage may be maintained within the balloon catheter for infusion of liquids and pressure measurements without requiring removal of the guide wire.

59. A set as defined in claim 58 wherein the main lumen of the catheter has a different cross-sectional shape than that of the guide wire.

60. A set as defined in claim 59 wherein the guide wire is circular in cross-section and the main lumen of the catheter is D-shaped in cross-section.

61. A set as defined in claim 57 wherein the outer diameter of the dilatation catheter is not greater than of the order of 0.050 inches.

62. A set as defined in claim 58 wherein said guide wire is circular in cross-section and wherein said main lumen is non circular in cross-section.

63. A set as defined in claim 58 wherein the cross-section defined by the guide wire is not greater than about 50 percent of the cross-sectional area of the main lumen in the catheter.

64. A set of a small diameter catheter and steerable guide wire for use therewith comprising:

a guide wire as defined in claim 50; and

a catheter having a lumen receptive to the guide wire, the lumen being open at the distal end of the catheter, said catheter having an outer diameter not greater than of the order of 0.050 inches.

65. A steerable small diameter guide wire having a proximal end and a distal end comprising:

a main wire having a proximal end and a distal region;

a helically wound spring connected to the distal region of the main wire, the length of the spring comprising a relatively short portion of the overall length of the guide wire and the main wire comprising the major portion of the overall length of the guide wire;

each of said main wire and spring having a maximum diameter which does not exceed 0.020 inches;

the distal end of the guide wire being constructed to be bendable to a set curved configuration and to retain that set curve when relaxed, said bendable distal end being sufficiently flexible so as to adapt to and follow the contours of a patient'"'"'s blood vessel;

the guide wire having means sufficiently torsionally rigid along its length for transmitting to the distal end of the guide wire substantially all of the angular rotation applied to the proximal end of the guide wire thereby enabling the guide wire with prebent distal end to be controllably directed to selected branches of the vascular system.

66. A guide wire as defined in claim 65 wherein the torsionally rigid means comprises:

said meain wire being formed from a solid rod.

67. A guide wire as defined in claim 65 wherein the torsionally rigid means comprises:

said main wire being formed from a solid walled tube.

69. A set for introducing a balloon dilatation catheter and for performing a balloon dilatation in a blood vessel comprising:

a guide wire as defined in claim 65; and

a balloon dilatation catheter having a main lumen which is receptive to the guide wire, said main lumen being open at the distal end of the catheter.

70. A set of a small diameter catheter and steerable guide wire for use therewith comprising:

a guide wire as defined in claim 65, and

a catheter having a lumen receptive to the guide wire, the lumen being open at the distal end of the catheter, said catheter having an outer diameter not greater than of the order of 0.050 inches.

68. A guide wire as defined in claim 68 wherein the outer diameter of each of the main wire and spring are substantially the same.