Ultrasound catheter having integrated drug delivery system and methods of using same

• US 5,997,497 A
• Filed: 06/18/1997
• Issued: 12/07/1999
• Est. Priority Date: 01/11/1991
• Status: Expired due to Fees

• Current Assignee: Advanced Cardiovascular Systems Incorporated
• Original Assignee: Advanced Cardiovascular Systems Incorporated
• Inventors: Nita, Henry, Siegel, Robert, Mills, Timothy
• Primary Examiner(s): Bockelman, Mark
• Application Number:
  US08/878,463
• Time in Patent Office: 902 Days
• Field of Search: 604/22, 604/280, 601/2, 607/97, 606/159
• US Class Current: 604/22
• 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 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 2017/22084 stone- or thrombus-dissolving

Abstract

An ultrasound delivery catheter equipped and configured for concurrent delivery of drugs or therapeutic agents. The catheter comprises an elongate pliable catheter body having an ultrasound delivery member or wire extending longitudinally therethrough. A drug/therapeutic agent infusion lumen also extends longitudinally through the body of the catheter and opens distally through one or more outflow apertures at or near the distal end of the catheter body. The drug/therapeutic agent outflow apertures are preferably positioned and configured to cause the drug or therapeutic agent to flow in direction(s) non-parallel to the longitudinal axis of the catheter. The delivery of ultrasound through the catheter, concurrent with infusion of drug or therapeutic agent therethrough, will cause the drug or therapeutic agent to be disseminated or dispersed by the ultrasonic vibration or movement at the distal end of the catheter.

Claims

1. An ultrasound delivery/medicament infusion catheter for delivering ultrasonic energy to a treatment location within a mammalian body concomitantly with an infusion of medicament, said catheter comprising:

an elongate flexible catheter body having a longitudinal axis, a proximal end, a distal end, an outer surface, and at least one hollow lumen extending longitudinally therethrough;

an ultrasound distal tip member disposed at the distal end of the catheter body;

an ultrasound transmission member extending longitudinally through said catheter body and being connected at the distal end thereof to the distal tip member, said ultrasound transmission member being coupleable to an ultrasound source such that ultrasonic vibration from said ultrasound source may be transmitted through said ultrasound transmission member to the ultrasonic distal tip member at the distal end of said catheter;

a medicament inlet formed near the proximal end of said catheter body for infusing a liquid medicament through a hollow lumen of said catheter; and

at least one medicament outlet aperture formed in the distal tip member and oriented radially outward in relation to the longitudinal axis of the catheter body and in fluid communication with the medicament inlet through the hollow lumen to permit medicament to flow out of said catheter generally along the radial direction;

whereby liquid medicament may be infused through said catheter, and out of said medicament outlet aperture(s), concurrently with the delivery of ultrasonic energy to the distal end of the catheter.

2. The catheter of claim 1 wherein the distal end of said ultrasound transmission member is frictionally engaged to said distal tip member.

3. The catheter of claim 1 wherein said catheter lumen has an open distal end and the distal tip member is plug-like in shape and is inserted into the distal end of said lumen and affixed to said catheter body, and further wherein said ultrasound transmission member extends through said lumen of said catheter body and is anchored to said distal tip member.

4. The catheter of claim 1 further comprising at least one medicament outlet aperture formed in the outer surface of said catheter body, adjacent the distal end thereof and oriented radially outward in relation to the longitudinal axis of the catheter body.

5. The catheter of claim 1 wherein said at least one medicament outlet aperture comprises a plurality of medicament outlet apertures formed at spaced apart locations about the outer surface of said distal tip member.

6. The catheter of claim 5 further comprises:

a plurality of medicament outlet apertures formed at spaced apart locations about the outer surface of said catheter body, adjacent said distal tip member.

7. The catheter of claim 5 wherein the plurality of medicament outlet apertures are oriented so that they face radially outward in relation to the longitudinal axis of the catheter body.

8. The catheter of claim 1 wherein said elongate flexible catheter body comprises:

an outer tube having a proximal end a distal end an a hollow lumen extending longitudinally therethrough; and

an inner tube having a proximal end, a distal end and a hollow lumen extending longitudinally therethrough;

said inner tube being longitudinally disposed within the lumen of said outer tube.

9. The catheter of claim 8 wherein the distal tip member is affixed to the distal ends of said inner and outer tubes.

10. The catheter of claim 9 wherein:

said outer tube has an inner diameter and an outer diameter; and

,

said inner tube has an inner diameter and an outer diameter;

the outer diameter of said inner tube being smaller than the inner diameter of said outer tube such that a medicament infusion space exists between the outer surface of said inner tube and the inner surface of said outer tube; and

wherein said medicament inlet port and said medicament outlet aperture(s) are in fluid communication with said space to facilitate infusion of liquid medicament therethrough.

11. The catheter of claim 10 wherein said medicament outlet aperture(s) comprises:

a plurality of apertures formed in said distal tip member around the periphery thereof and oriented radially outward such that medicament flowing through said space will pass out of said medicament outlet apertures.

12. The catheter of claim 1 further comprising:

a hollow guidewire passage bore extending longitudinally through the distal end of said catheter.

13. A system for delivering ultrasonic energy along with a flow of liquid medicament to a treatment location within a mammalian body, said system comprising:

the catheter of claim 1 in combination with;

an electrical signal generator for generating an electrical wave form signal;

an ultrasound transducer connected to said signal generator for converting said electrical signal to ultrasonic energy; and

said ultrasound transducer being coupled to the proximal end of the ultrasound transmission member of said catheter.

14. The catheter of claim 12 wherein said guidewire passage bore is located separately from the lumen so that it is not in fluid communication with the lumen;

whereby cooling fluid may be applied through the guidewire passage bore while medicament is simultaneously applied through the lumen.

15. The catheter of claim 14 comprising a plurality of apertures formed at spaced-apart locations about the outer surface of the catheter body, adjacent the distal end thereof.

16. The catheter of claim 15 comprising a plurality of medicament outlet apertures formed at spaced-apart locations about the outer surface of the distal tip member and oriented radially outward.

17. An ultrasound catheter for delivering ultrasonic energy and fluid concomitantly to a treatment location within a mammalian body, said catheter comprising:

an elongate flexible catheter body having a longitudinal axis, a proximal end, a distal end, an outer surface, and a first lumen extending longitudinally therethrough;

an ultrasound distal tip member disposed at the distal end of the catheter body;

a solid ultrasound transmission member extending longitudinally through said catheter body and being connected at the distal end thereof to the distal tip member, said ultrasound transmission member being coupleable to an ultrasound source such that ultrasonic vibration from said ultrasound source may be transmitted through said ultrasound transmission member to the ultrasonic distal tip member at the distal end of said catheter;

a fluid inlet formed near the proximal end of said catheter body for infusion of a fluid through a hollow lumen of said catheter; and

a fluid outlet aperture formed in the distal tip of said catheter and oriented radially outward in relation to the longitudinal axis of the catheter body to permit the fluid to flow out of said catheter generally along the radial direction;

whereby a fluid may be infused through said catheter, and out of said outlet aperture concurrently with the delivery of ultrasonic energy to the distal end of the catheter.

18. The catheter of claim 17 wherein the medicament outlet aperture is formed in the distal tip member and oriented radially outward in relation to the tip and in fluid communication with the medicament inlet through the hollow lumen to permit medicament to flow out of said catheter.

19. The catheter of claim 18 further comprising a plurality of medicament outlet apertures disposed in spaced-apart locations about the outer surface of the catheter body adjacent the distal end thereof.

20. The catheter of claim 19 comprising a plurality of medicament outlet apertures disposed in the distal tip member at spaced-apart locations and oriented radially outward.

21. The catheter of claim 20 further comprising a guidewire lumen disposed in the catheter body separate from the first lumen so that the lumina are not in fluid communication with each other;

wherein fluid may be infused through the guidewire lumen and different fluid may be infused through the first lumen.