Catheter having a distal drug delivery unit and method of using same

• US 7,686,788 B2
• Filed: 03/03/2005
• Issued: 03/30/2010
• Est. Priority Date: 03/03/2005
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Palasis, Maria, Naimark, Wendy, Freyman, Toby, Mickley, Timothy J.
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): VU, QUYNH-NHU HOANG
• Application Number:
  US11/070,190
• Publication Number:
  US 20060200083A1
• Time in Patent Office: 1,853 Days
• Field of Search: 604/96.01, 604/97.02, 604/99.01, 604/99.02, 604/118, 604/121, 604124-125, 604140-143, 604146-147, 604/151, 604/153, 604/164.01, 604/181, 604/185, 604/187, 604/212, 604/216, 604/217, 604/90, 604/93.01, 604/95.02, 604/131, 604/132, 604/133, 604/150, 604 57- 60, 604/64, 604/145, 604/410, 604/406
• US Class Current: 604/181
• CPC Class Codes: A61M 2025/0091 the single injection needle being fixed
• CPC Class Codes: A61M 25/0074 Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
• CPC Class Codes: A61M 25/0082 Catheter tip comprising a tool
• CPC Class Codes: A61M 25/0084 being one or more injection needles
• CPC Class Codes: A61M 5/14526 the piston being actuated by fluid pressure
• CPC Class Codes: A61M 5/14593 the diaphragm being actuated by fluid pressure
• CPC Class Codes: A61M 5/148 flexible, e.g. independent bagsA61M5/155 takes precedence
• CPC Class Codes: A61M 5/1483 using flexible bags externally pressurised by fluid pressure

Abstract

A catheter having a drug delivery unit at the distal end thereof. The drug delivery unit includes an actuator capable of assuming an activated and an inactivated configuration. The drug delivery unit also includes a receptacle capable of accepting a therapeutic agent. The actuator and receptacle are in communication with each other such that the actuator transmits force to the receptacle and the receptacle accepts force from the actuator in an activated configuration of the actuator. Also provided is a method of delivering a therapeutic agent to a target site using the catheter of the present invention.

Claims

1. A catheter comprising:

a hollow, flexible tube having an infusion lumen extending partially therethrough and

a drug delivery unit within a distal end of the tube and adapted to be adjacent to a target site in the body, the drug delivery unit comprising;

an actuator in fluid communication with the infusion lumen of the tube, the actuator having an un-expanded inactivated configuration and an expanded activated configuration;

a receptacle in communication with the actuator such that the actuator transmits force to the receptacle in the activated configuration, and

a retractable needle in fluid communication with a distal end of the receptacle.

2. The catheter of claim 1, wherein the receptacle is a drug delivery balloon.

3. The catheter of claim 1, wherein the drug delivery unit further comprises a drug delivery lumen extending partially therethrough, the drug delivery lumen in fluid communication with the receptacle at one end and in fluid communication with the needle at another end.

4. The catheter of claim 3, wherein a pressure-sensitive membrane is located between the receptacle and the drug delivery lumen.

5. The catheter of claim 1, wherein the actuator is a balloon.

6. The catheter of claim 1, wherein the actuator is a piston.

7. The catheter of claim 6, wherein the piston has an O-ring disposed therearound, the O-ring contacting opposing inner side surfaces of the catheter.

8. The catheter of claim 6, wherein the piston is slidably received within the catheter with a close tolerance fit between an outer surface of the piston and opposing inner side surfaces of the catheter.

9. The catheter of claim 1, wherein the actuator is a spring-loaded coil.

10. The catheter of claim 1, wherein the actuator is fabricated of a temperature-sensitive material having a transition temperature, the actuator assuming an activated configuration when the temperature-sensitive material reaches the transition temperature.

11. The catheter of claim 1, wherein the receptacle is a balloon.

12. The catheter of claim 1, wherein the receptacle is a chamber.

13. The catheter of claim 12, wherein the chamber has a front end defined by a first pressure-sensitive gate.

14. The catheter of claim 13, wherein the chamber has a back end defined by a second pressure sensitive gate.

15. The catheter of claim 12, wherein the chamber has a back end defined by a pressure sensitive gate.

16. The catheter of claim 1, wherein the actuator is a first balloon and the receptacle is a second balloon.

17. The catheter of claim 1, wherein the actuator comprises a first primary balloon and a first secondary balloon and the receptacle comprises a second balloon, the second balloon disposed between the first primary balloon and the first secondary balloon.

18. The catheter of claim 1, wherein the actuator is a plurality of balloons.

19. The catheter of claim 1, further comprising a plurality of drug delivery units.

20. The catheter of claim 19, wherein each of the drug delivery units holds a different therapeutic agent.

25. The catheter of claim 1, further comprising a therapeutic agent within the receptacle.

21. A catheter comprising:

a hollow, flexible tube comprising an inner shaft having an infusion lumen extending partially therethrough, an outer shaft disposed around the inner shaft, and a drug delivery unit within a distal end of the tube and adapted to be adjacent to a target site in the body, the drug delivery unit comprising;

an actuator in fluid communication with the infusion lumen, the actuator having an unexpanded inactivated configuration and an expanded activated configuration; and

a receptacle in fluid communication with a retractable needle, the receptacle and actuator in communication with each other, such that the actuator transmits force to the receptacle in the activated configuration.

22. A method of delivering a therapeutic agent to a target site comprising:

providing a catheter having a distal end comprising a drug delivery unit;

placing a therapeutic agent in the drug delivery unit; and

delivering the therapeutic agent to the target site.

23. The method of claim 22, wherein the catheter comprises a needle at the distal end thereof.

24. The method of claim 23, wherein placing a therapeutic agent in the drug delivery unit comprises accessing the drug delivery unit through the needle of the catheter.

26. A catheter comprising:

a flexible, hollow tube having a proximal end adapted to receive an infusion material, a distal end adapted to deliver a therapeutic to a patient, and an infusion lumen extending partially therethrough, the tube comprising;

a drug delivery unit at the distal end of the tube, the drug delivery unit comprising;

an actuator at a distal end of the infusion lumen and in fluid communication therewith, the actuator having an inactivated configuration and an activated configuration;

a therapeutic receptacle distal to the actuator,

a retractable needle at a distal end of the therapeutic receptacle,

wherein the actuator transmits force to the therapeutic receptacle in the activated configuration to deliver a therapeutic to the patient.

27. The catheter of claim 26, wherein when in use, infusion material travels through the infusion lumen to place the actuator in the activated configuration.

28. The catheter of claim 26, wherein when in use, force transmitted to the therapeutic receptacle delivers a therapeutic through the needle to a target site.

29. The catheter of claim 26, wherein an interior of the receptacle is fluidly isolated from the infusion lumen and the actuator.