Ultrasound catheter devices and methods

• US 7,540,852 B2
• Filed: 08/26/2004
• Issued: 06/02/2009
• Est. Priority Date: 08/26/2004
• Status: Active Grant

• Current Assignee: Flowcardia Inc. (Becton, Dickinson & Co)
• Original Assignee: Flowcardia Inc. (Becton, Dickinson & Co)
• Inventors: Nita, Henry, Spano, Richard, Sarge, Jeff
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): KOHARSKI, CHRISTOPHER
• Application Number:
  US10/927,966
• Publication Number:
  US 20060047239A1
• Time in Patent Office: 1,741 Days
• Field of Search: 604/22, 604/113, 604/264, 606/169, 606/159, 606/128, 606/28, 600/439
• US Class Current: 604/22
• CPC Class Codes: A61B 17/22004 using mechanical vibrations, e.g. ultrasonic shock waves A61B17/225 takes precedence
• CPC Class Codes: A61B 17/22012 in direct contact with, or very close to, the obstruction or concrement for removing obstructions in blood vessels by laser A61B18/245
• CPC Class Codes: A61B 17/2251 characterised by coupling elements between the apparatus, e.g. shock wave apparatus or locating means, and the patient, e.g. details of bags, pressure control of bag on patient
• CPC Class Codes: A61B 2017/00477 Coupling A61B2017/0046 takes precedence
• CPC Class Codes: A61B 2017/22014 the ultrasound transducer being outside patient's body; with an ultrasound transmission member; with a wave guide; with a vibrated guide wire not applied in A61B17/22012

Abstract

Ultrasound catheter devices and methods provide enhanced disruption of blood vessel obstructions. Generally, an ultrasound catheter device includes an elongate flexible catheter body with one or more lumens, an ultrasound transmission member extending longitudinally through the catheter body lumen and a distal head coupled with the transmission member and positioned adjacent the distal end of the catheter body for disrupting occlusions. A proximal housing of the catheter device may include one or more features for dissipating heat from the ultrasound transmission wire, such as a fluid inlet aperture for passage of fluid, use of heat conductive materials in the proximal housing, surface features to increase the housing'"'"'s surface area, heat conductive members disposed adjacent the transmission member and the like. Various irrigation fluids may be used, such as cooled, oxygen supersaturated or lubricious fluids.

Claims

1. An ultrasound catheter for disrupting occlusions in blood vessels, the ultrasound catheter comprising:

an elongate flexible catheter body having a proximal end, a distal end and at least one lumen;

an ultrasound transmission member extending longitudinally through the lumen of the catheter body and having a proximal end and a distal end;

a distal head coupled with the distal end of the ultrasound transmission member and disposed adjacent the distal end of the catheter body;

a sonic connector coupled with the proximal end of the ultrasound transmission member for coupling the ultrasound transmission member with an ultrasound transducer device; and

a proximal housing coupled with the proximal end of the catheter body and housing the sonic connector and a proximal portion of the ultrasound transmission member,

a heat absorption member disposed around the ultrasound transmission member, the heat absorption member comprising a metalized elastomer;

a first O-ring member disposed around the ultrasound transmission member, and disposed proximal to the heat absorption member; and

a second O-ring member disposed around the ultrasound transmission member, and disposed distal to the heat absorption member.

2. An ultrasound catheter as in claim 1, wherein one or more portions of the proximal housing comprise a heat conductive material.

3. An ultrasound catheter as in claim 2, wherein the heat conductive material is selected from the group consisting of metal, polymer, glass, rubber and combinations thereof.

4. An ultrasound catheter as in claim 1 or 2, wherein the proximal housing comprises multiple surface features to increase a surface area of the proximal housing.

5. An ultrasound catheter as in claim 4, wherein the surface features are selected from the group consisting of grooves, notches, waves and dips.

6. An ultrasound catheter as in claim 1 or 2, further comprising at least one conductive material disposed within the proximal housing, at least partially encircling the ultrasound transmission member, to conduct heat away from the ultrasound transmission member.

7. An ultrasound catheter as in claim 6, wherein the conductive material is disposed adjacent one or more vibration absorption members surrounding the ultrasound transmission member.

8. An ultrasound catheter as in claim 7, wherein the at least one conductive material comprises multiple separate conductive members disposed between multiple vibration absorption members and at least partially encircling the ultrasound transmission member.

9. An ultrasound catheter as in claim 6, wherein the conductive material is arranged over one or more vibration absorption members surrounding the ultrasound transmission member.

10. An ultrasound catheter as in claim 1, wherein at least a portion of the proximal housing comprises a material adapted to change color when the temperature of the housing changes.

11. An ultrasound catheter as in claim 10, wherein the material comprises a thermochromic pigment.

12. An ultrasound catheter as in claim 11, wherein the thermochromic pigment changes from a first color to a second color when the temperature of the housing reaches approximately 45°

Celsius and changes from the second color to the first color when the temperature of the housing drops below approximately 45°

Celsius.

13. An ultrasound catheter for disrupting occlusions in blood vessels, the ultrasound catheter comprising:

an elongate flexible catheter body having a proximal end, a distal end and at least one lumen;

an ultrasound transmission member extending longitudinally through the lumen of the catheter body and having a proximal end and a distal end;

a distal head coupled with the distal end of the ultrasound transmission member and disposed adjacent the distal end of the catheter body;

a sonic connector coupled with the proximal end of the ultrasound transmission member for coupling the ultrasound transmission member with an ultrasound transducer device; and

a proximal housing coupled with the proximal end of the catheter body and housing the sonic connector and a proximal portion of the ultrasound transmission wire, and member; and

a plurality of O-ring members disposed around and contacting a portion of the ultrasound transmission member wherein the proximal housing comprises a fluid inlet for allowing passage of one or more heat dissipating fluids into an inner cavity of the proximal housing, and wherein the inlet is disposed along the proximal housing such that the heat dissipating fluid(s) passing through the inlet flows within the inner cavity, and across the plurality of 0-ring members in a distal direction before contacting the ultrasound transmission member.

14. An ultrasound catheter as in claim 13, wherein the inner cavity of the housing is in fluid communication with the lumen of the catheter body, such that fluid introduced into the inner cavity passes through and out a distal end of the catheter body lumen.

15. An ultrasound catheter as in claim 13, wherein the inlet is disposed along the housing such that the heat dissipating fluid(s) passing through the inlet contact the sonic connector and the portion of the ultrasound transmission member.

16. An ultrasound catheter as in claim 13, further comprising a refrigeration deyice coupled with the catheter for refrigerating a fluid to be introduced through the fluid inlet.

17. An ultrasound catheter as in claim 13, further comprising a guidewire tube extending through at least a portion of the catheter body for allowing passage of a guidewire.

18. An ultrasound catheter as in claim 17, wherein a sidewall of the guidewire tube includes a plurality of apertures for allowing fluid introduced into the lumen of the catheter body to pass into and through the guidewire tube.

19. An ultrasound catheter for disrupting occlusions in blood vessels, the ultrasound catheter comprising:

an elongate flexible catheter body having a proximal end, a distal end and at least one lumen;

an ultrasound transmission member extending longitudinally through the lumen of the catheter body and having a proximal end and a distal end;

a distal head coupled with the distal end of the ultrasound transmission member and disposed adjacent the distal end of the catheter body;

a sonic connector coupled with the proximal end of the ultrasound transmission member for coupling the ultrasound transmission member with an ultrasound transducer device;

a vibration absorption member disposed around a portion of the ultrasound transmission member; and

a proximal housing coupled with the proximal end of the catheter body and housing the sonic connector and a proximal portion of the ultrasound transmission wire;

wherein the proximal housing comprises a fluid inlet port for allowing passage of a heat dissipating fluid into an inner cavity of the proximal housing, and wherein the fluid inlet port is disposed along the proximal housing such that the heat dissipating fluid passing through the fluid inlet flows across a portion of the ultrasound transmission member proximal to the vibration absorption member, then flows across the vibration absorption member in a distal direction before contacting a portion of the ultrasound transmission member distal to the vibration absorption member.

20. An ultrasound catheter as in claim 19, wherein the proximal housing compnses one or more portions constructed of a heat conductive material.

21. An ultrasound catheter as in claim 20, wherein the heat conductive material is selected from the group consisting of metal, polymer, glass, rubber and combinations thereof.

22. An ultrasound catheter as in claim 20, wherein the proximal housing further comprises multiple surface features on the proximal housing to increase a surface area of the proximal housing.

23. An ultrasound catheter as in claim 22, wherein the surface features are selected from the group consisting of grooves, notches, waves and dips.

24. An ultrasound catheter as in claim 19, further comprising at least one conductive material disposed within the proximal housing, at least partially encircling the ultrasound transmission member, to conduct heat away from the ultrasound transmission member.

25. An ultrasound catheter as in claim 24, wherein the conductive material is disposed adjacent the vibration absorption members.

26. An ultrasound catheter as in claim 25, further comprising multiple vibration absorption members, wherein the conductive material comprises multiple separate conductive members disposed between the multiple vibration absorption members and at least partially encircling the ultrasound transmission member.

27. An ultrasound catheter as in claim 24, wherein the conductive material is arranged over one or more vibration absorption members surrounding the ultrasound transmission member.

28. An ultrasound catheter as in claim 19, wherein at least a portion of the proximal housing comprises a material adapted to change color when the temperature of the housing changes.

29. An ultrasound catheter as in claim 28, wherein the material comprises a thermochromic pigment.

30. An ultrasound catheter as in claim 29, wherein the thermochromic pigment changes from a first color to a second color when the temperature of the housing reaches approximately 45°

Celsius and changes from the second color to the first color when the temperature of the housing drops below approximately 45°

Celsius.

31. An ultrasound catheter for disrupting occlusions in blood vessels, the ultrasound catheter comprising:

an elongate flexible catheter body having a proximal end, a distal end and at least one lumen;

an ultrasound transmission member extending longitudinally through the lumen of the catheter body and having a proximal end and a distal end;

a distal head coupled with the distal end of the ultrasound transmission member and disposed adjacent the distal end of the catheter body;

a sonic connector coupled with the proximal end of the ultrasound transmission member for coupling the ultrasound transmission member with an ultrasound transducer device;

an O-ring member disposed around a portion of the ultrasound transmission member; and

a proximal housing coupled with the proximal end of the catheter body and housing the sonic connector and a proximal portion of the ultrasound transmission-wi*e member;

wherein the proximal housing comprises a fluid inlet port for allowing passage of a heat dissipating fluid into an inner cavity of the proximal housing, and wherein the fluid inlet port is disposed along the proximal housing such that the heat dissipating fluid passing through the fluid inlet flows across a portion of the ultrasound transmission member proximal to the O-ring member, then flows across the O-ring member in a distal direction before contacting a portion of the ultrasound transmission member distal to the vibration absorption member.

32. An ultrasound catheter as in claim 31, wherein the inner cavity of the housing is in fluid communication with the lumen of the catheter body, such that fluid introduced into the inner cavity passes through and out a distal end of the catheter body lumen.

33. An ultrasound catheter as in claim 31, wherein the inlet is disposed along the housing such that the heat dissipating fluid(s) passing through the inlet contact a proximal portion of the ultrasound transmission member.

34. An ultrasound catheter as in claim 31, wherein the inlet is disposed along the housing such that the heat dissipating fluid passing through the inlet contact the sonic connector and the portion of the ultrasound transmission member.

35. An ultrasound catheter as in claim 31, further comprising a refrigeration device coupled with the catheter for refrigerating a fluid to be introduced through the fluid inlet.

36. An ultrasound catheter as in claim 31, further comprising a guidewire tube extending through at least a portion of the catheter body for allowing passage of a guidewire.

37. An ultrasound catheter as in claim 36, wherein a sidewall of the guidewire tube includes a plurality of apertures for allowing fluid introduced into the lumen of the catheter body to pass into and through the guidewire tube.