STEERABLE ULTRASOUND CATHETER

• US 20080167602A1
• Filed: 01/28/2008
• Published: 07/10/2008
• Est. Priority Date: 11/24/2003
• Status: Active Grant

• Current Assignee: Flowcardia Inc. (Becton, Dickinson & Co)
• Original Assignee: Flowcardia Inc. (Becton, Dickinson & Co)
• Inventors: Nita, Henry, Sarge, Jeff
• Granted Patent: US 8,613,751 B2
• Time in Patent Office: Days
• 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 17/2202 the ultrasound transducer being inside patient's body at the distal end of the catheter
• CPC Class Codes: A61B 17/320068 using mechanical vibrations, e.g. ultrasonic A61B17/22012 takes precedence; dental tooth drilling devices operated by vibration A61C3/03; removing intra-ocular material using mechanical vibrations A61F9/00745
• CPC Class Codes: A61B 17/3207 Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions A61B17/32037 takes precedence; endoscopic cutting instruments A61B17/320016
• CPC Class Codes: A61B 2017/00243 cardiac
• 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
• CPC Class Codes: A61B 2017/308 with suction cups
• CPC Class Codes: A61B 2017/32007 with suction or vacuum means
• CPC Class Codes: A61B 2017/320071 with articulating means for working tip
• CPC Class Codes: A61M 25/0054 with regions for increasing flexibility

Abstract

Ultrasound catheter devices and methods provide enhanced disruption of blood vessel obstructions. Ultrasound catheter devices generally include 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. Improved features of ultrasound catheters include catheter bodies and ultrasound transmission members with increasing distal flexibility, guidewire tubes allowing contact between a guidewire and an ultrasound transmission member, distal heads with improved guidewire lumens, and torquable proximal housings for enhancing disruption of blood vessel occlusions.

Claims

1. An ultrasound catheter for disrupting occlusions in blood vessels which can be guided along a guidewire from an access site on a patient'"'"'s body to a target site adjacent an occlusion, the ultrasound catheter comprising:

an elongate flexible catheter body having a proximal portion, a distal portion and at least one lumen, wherein the proximal portion has a larger cross-sectional diameter than the distal portion, the proximal portion is sufficiently stiff to push the distal portion through a blood vessel having at least one bend, and the distal portion is sufficiently flexible to pass through the bend in the blood vessel;

an ultrasound transmission member extending longitudinally through the lumen of the catheter body and having a proximal end and a distal end, wherein a cross-sectional diameter of the ultrasound transmission member is less near its distal end than near its proximal end, and a distal portion of the ultrasound transmission member is sufficiently flexible to pass through the bend in the blood vessel;

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

at least one coupling member for coupling the ultrasound transmission member with a source of ultrasound energy.

2. An ultrasound catheter as in claim 1, wherein the distal portion is sufficiently flexible to pass, without kinking, through at least 5 cm of the blood vessel, wherein the blood vessel has an inner diameter of between about 2 mm and about 5 mm, and the at least one bend has a radius of about 1.0 cm or smaller.

3. An ultrasound catheter as in claim 1, wherein a wall thickness of the catheter body is less along the distal portion than along the proximal portion.

4. An ultrasound catheter as in claim 3, wherein the wall thickness is between about 0.007 cm to about 0.020 cm along its proximal portion and about 0.005 cm to about 0.013 cm along its distal portion.

5. An ultrasound catheter for disrupting occlusions in blood vessels which can be guided along a guidewire from an access site on a patient'"'"'s body to a target site adjacent an occlusion, the ultrasound catheter comprising:

an elongate flexible catheter body having a proximal portion, a distal portion, a distally narrowing taper, and at least one lumen, wherein the proximal portion is stiffer than the distal portion, and the distal portion is more flexible near a distal end of the catheter body than near the proximal portion of the catheter body;

an ultrasound transmission member extending longitudinally through the lumen of the catheter body and having a proximal end and a distal end, and a distally narrowing taper, wherein the ultrasound transmission member is more flexible near its distal end than near its proximal end, and wherein the distal portion of the catheter body and the ultrasound transmission member are sufficiently flexible to conform concomitantly with at least one bend in a guidewire extended through the at least one lumen;

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 distal end that is flush with a distal end of the distal head; and

at least one coupling member for coupling the ultrasound transmission member with a source of ultrasound energy,

wherein the distally narrowing taper of the ultrasound transmission member extends distally beyond the distally narrowing taper of the elongate flexible catheter body.

6. An ultrasound catheter as in claim 5, wherein the distal portion of the catheter body and the ultrasound transmission wire are sufficiently flexible to conform concomitantly to multiple bends in the guidewire.

7. An ultrasound catheter as in claim 6, wherein the distal portion of the catheter body and the ultrasound transmission member are sufficiently flexible to conform concomitantly to multiple bends in a blood vessel.

8. An ultrasound catheter as in claim 7, wherein the distal portion of the catheter body, the ultrasound transmission wire and the guidewire may be passed together or sequentially through the multiple bends in the blood vessel while conforming concomitantly to the multiple bends.

9. An ultrasound catheter for disrupting occlusions in blood vessels which can be guided along a guidewire from an access site on a patient'"'"'s body to a target site adjacent an occlusion, the ultrasound catheter comprising:

an elongate flexible catheter body having a proximal portion, a distal portion having at least one bend, and at least one lumen, wherein the proximal portion is stiffer than the distal portion, and the distal portion is more flexible near a distal end of the catheter body than near the proximal portion of the catheter body;

an ultrasound transmission member extending longitudinally through the lumen of the catheter body and having a proximal end and a distal end, wherein the ultrasound transmission member is more flexible near its distal end than near its proximal end, wherein the ultrasound transmission member conforms to the at least one bend in the distal portion of the catheter body, and wherein the distal portion of the catheter body and the ultrasound transmission member are sufficiently flexible to conform concomitantly to at least one bend in a guidewire extended through the at least one lumen;

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

at least one coupling member for coupling the ultrasound transmission member with a source of ultrasound energy.

10. An ultrasound catheter as in claim 9, wherein the distal portion of the catheter body and the ultrasound transmission wire are sufficiently flexible to conform concomitantly to multiple bends in the guidewire.

11. An ultrasound catheter as in claim 10, wherein the distal portion of the catheter body and the ultrasound transmission member are sufficiently flexible to conform concomitantly to multiple bends in a blood vessel.

12. An ultrasound catheter as in claim 11, wherein the distal portion of the catheter body, the ultrasound transmission wire and the guidewire may be passed together or sequentially through the multiple bends in the blood vessel while conforming concomitantly to the multiple bends.

13. An ultrasound catheter for disrupting occlusions in blood vessels which can be guided from an access site on a patient'"'"'s body to a target site adjacent an occlusion, the ultrasound catheter comprising:

an elongate flexible catheter body having a proximal portion, a distal portion, at least one lumen, and a guidewire tube disposed within the lumen, wherein the proximal portion is stiffer than the distal portion;

an ultrasound transmission member extending longitudinally through the lumen of the catheter body;

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

at least one coupling member for coupling the ultrasound transmission member with a source of ultrasound energy;

wherein the guidewire tube includes at least one opening within the catheter body for providing contact between a guidewire extending through the guidewire tube and the ultrasound transmission member, and wherein the ultrasound transmission member passes through the guidewire tube via the at least one opening to contact the guidewire.

14. An ultrasound catheter as in claim 13, wherein the distal portion of the catheter body is more flexible near a distal end of the catheter body than near the proximal portion of the catheter body.

15. An ultrasound catheter as in claim 13, wherein the ultrasound transmission member comprises a proximal end and a distal end, and wherein the ultrasound transmission member is more flexible near its distal end than near its proximal end.

16. An ultrasound catheter as in claim 13, wherein the at least one opening provides for contact between the guidewire and ultrasound transmission wire nearer the distal end of the catheter body than a proximal end of the catheter body.

17. An ultrasound catheter as in claim 13, wherein the at least one opening provides for contact between the guidewire and the ultrasound transmission wire nearer a proximal end of the catheter body than the distal end of the catheter body.

18. An ultrasound catheter as in claim 13, wherein the at least one opening provides for contact between the guidewire and the ultrasound transmission wire near the middle of the catheter body.

19. An ultrasound catheter for disrupting occlusions in blood vessels which can be guided from an access site on a patient'"'"'s body to a target site adjacent an occlusion, the ultrasound catheter comprising:

an elongate flexible catheter body having a proximal portion, a distal portion and at least one lumen, wherein the proximal portion is stiffer than the distal portion;

an ultrasound transmission member extending longitudinally through the lumen of the catheter body;

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

a guidewire aperture in a center of a distal end of the distal head; and

a guidewire lumen extending through the distal head, the guidewire lumen having a different longitudinal axis than a longitudinal axis of the catheter body; and

at least one coupling member for coupling the ultrasound transmission member with a source of ultrasound energy.

20. An ultrasound catheter as in claim 19, wherein the distal portion of the catheter body is more flexible near a distal end of the catheter body than near the proximal portion of the catheter body.

21. An ultrasound catheter as in claim 19, wherein the ultrasound transmission member comprises a proximal end and a distal end, and wherein the ultrasound transmission member is more flexible near its distal end than near its proximal end.

22. An ultrasound catheter as in claim 19, wherein the guidewire lumen includes a cavity in which a distal end of a guidewire tube of the catheter body is disposed.

23. An ultrasound catheter as in claim 22, wherein the cavity extends through the distal end of the distal head, such that the distal end of the guidewire tube is flush with the distal end of the distal head.

24. An ultrasound catheter as in claim 22, wherein the cavity extends partially through the distal head, such that the distal end of the guidewire tube is disposed proximal to the distal end of the distal head.

25. An ultrasound catheter for disrupting occlusions in blood vessels which can be guided from an access site on a patient'"'"'s body to a target site adjacent an occlusion, the ultrasound catheter comprising:

an elongate flexible catheter body having a proximal portion, a distal portion and at least one lumen, wherein the proximal portion is stiffer than the distal portion, and the distal portion is more flexible near a distal end of the catheter body than near the proximal portion of the catheter body;

an ultrasound transmission member extending longitudinally through the lumen of the catheter body and having a proximal end and a distal end, wherein the ultrasound transmission member is more flexible near its distal end than near its proximal 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 that extends partially through the distal head, the guidewire tube having a distal end that is proximal to a distal end of the distal head; and

at least one coupling member for coupling the ultrasound transmission member with a source of ultrasound energy, the at least one coupling member comprising a housing fixedly coupled with the proximal end of the catheter body such that torque applied to the housing is transmitted along the catheter body to its distal portion,

wherein the guidewire tube comprises a longitudinal axis that is different from a longitudinal axis of the catheter body.