Ultrasound catheter devices and methods

• US 8,790,291 B2
• Filed: 04/22/2009
• Issued: 07/29/2014
• 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, Sarge, Jeff, Spano, Richard
• Primary Examiner(s): Price, Nathan R
• Application Number:
  US12/428,183
• Publication Number:
  US 20090216246A1
• Time in Patent Office: 1,924 Days
• Field of Search: 604/22, 604/113, 604/264, 606/28, 606/128, 606/159, 606/169, 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 system for disrupting occlusions in blood vessels, the system comprising:

an ultrasound catheter device, 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 guidewire tube having a proximal end, a distal end, at least one lumen, and at least one aperture, the at least one aperture being disposed between the proximal end and the distal end of the guidewire tube and within 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 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, wherein the housing includes at least one fluid inlet for allowing passage of one or more heat dissipating fluids into an inner cavity of the housing, and wherein the lumen of the catheter body is in fluid communication with the lumen of the guidewire tube such that at least a portion of the heat dissipating fluid(s) introduced into the cavity passes through and out of the distal end of the guidewire lumen;

an ultrasound generator removably coupled with the ultrasound catheter device; and

a fluid cooling device removably coupled with the ultrasound catheter device for cooling the heat dissipating fluid(s).

2. A system as in claim 1, wherein one or more portions of the housing are constructed of a heat conductive material.

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

4. A system as in claim 2, wherein the housing further comprises multiple surface features to increase a surface area of the housing.

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

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

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

8. A system 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. A system as in claim 6, wherein the conductive material is arranged over one or more vibration absorption members surrounding the ultrasound transmission member.

10. A system as in claim 1, wherein the inner cavity of the housing is in fluid communication with the lumen of the catheter body, such that at least a portion of the fluid introduced into the inner cavity passes through and out the distal end of the catheter body lumen.

11. A system as in claim 1, wherein the inlet is disposed along the housing such that the heat dissipating fluid(s) passing through the inlet contact at least one vibration absorption member disposed over the ultrasound transmission member.

12. A system as in claim 1, wherein the inlet is disposed along the housing such that the heat dissipating fluid(s) passing through the inlet contact the sonic connector and a portion of the ultrasound transmission member.

13. A system 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.

14. A system as in claim 13, wherein the material comprises a thermochromic pigment.

15. A system as in claim 14, 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.

16. A system as in claim 11, wherein the inlet is disposed along the housing such that the heat dissipating fluid(s) passing through the inlet contact the sonic connector and a portion of the ultrasound transmission member.

17. A system as in claim 1, further comprising a fluid container containing the heat dissipating fluid(s), the heat dissipating fluid(s) flowing through fluid cooling device before entering the proximal housing.

18. A system as in claim 1, wherein the heat dissipating fluid(s) comprises a lubricious fluid.

19. A system as in claim 1 further comprising a guidewire disposed within the guidewire lumen, the guidewire lumen being sized to allow the heat dissipating fluid(s) to lubricate the guidewire.

20. A system as in claim 19, wherein at least a portion of the guidewire passes through the distal end of the guidewire tube.

21. An ultrasound catheter comprising:

an elongate body having at least one lumen;

an ultrasound transmission member extending longitudinally through the at least one lumen of the body; and

a guidewire tube having a proximal end, a distal end, at least one lumen, and at least one aperture, the at least one aperture being disposed between the proximal end and the distal end of the guidewire tube and within the body so that the at least one lumen of the body is in fluid communication with the at least one lumen of the guidewire tube.

22. A catheter as in claim 21 further comprising a housing coupled with the body, the housing having at least one fluid inlet for allowing passage of one or more heat dissipating fluids into an inner cavity of the housing, the inner cavity being in fluid communication with the at least one lumen of the body.

23. A catheter as in claim 21 further comprising a distal head coupled to the ultrasonic transmission member, at least a portion of the guidewire tube passing through the distal head.

24. A catheter as in claim 21 further comprising a guidewire disposed within the guidewire tube, the guidewire tube being sized larger than the guidewire to allow a fluid to flow around the guidewire.

25. A system as in claim 21 further comprising a fluid cooling device removably coupled with the ultrasound catheter.

26. An 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;

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

a guidewire tube having a proximal end, a distal end, at least one lumen, and at least one aperture, the at least one aperture being disposed between the proximal end and the distal end of the guidewire tube and within the catheter body; and

a proximal housing coupled with the catheter body and housing a portion of the ultrasound transmission member, the housing having at least one fluid inlet in fluid communication with the at least one lumen of the catheter body,

wherein the at least one lumen of the catheter body is in fluid communication with the at least one lumen of the guidewire tube via the at least one aperture.