System and method for delivering thermally sensitive and reverse-thermal gelation materials

• US 6,726,654 B2
• Filed: 12/02/2002
• Issued: 04/27/2004
• Est. Priority Date: 08/05/1999
• Status: Expired due to Term

• Current Assignee: BioCardia, Inc
• Original Assignee: BioCardia, Inc
• Inventors: Rosenman, Daniel C.
• Primary Examiner(s): NORMAN, MARC E
• Application Number:
  US10/308,344
• Publication Number:
  US 20030125665A1
• Time in Patent Office: 512 Days
• Field of Search: 604/113, 604/264, 606/21, 606/22, 606/23, 606/24, 606/25, 606/27, 606/28
• US Class Current: 604/113
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/005 hardenable using external energy source, e.g. laser, ultrasound
• CPC Class Codes: A61M 2025/0004 having two or more concentrically arranged tubes for forming a concentric catheter system
• CPC Class Codes: A61M 2025/0089 Single injection needle protruding axially, i.e. along the longitudinal axis of the catheter, from the distal tip
• CPC Class Codes: A61M 2205/3633 thermally insulated
• CPC Class Codes: A61M 25/0084 being one or more injection needles
• CPC Class Codes: A61M 5/44 having means for cooling or heating the devices or media

Abstract

A catheter for injecting a thermally sensitive gelation material to remote sites within a patient'"'"'s body by maintaining the thermally sensitive gelation material in a liquid state until it is delivered to a target area within the body.

Claims

1. A catheter system for injecting a therapeutic agent into a target site within the body of a patient, wherein the therapeutic agent exhibits differing viscosity at different temperatures, said catheter system comprising:

a catheter having a distal end adapted for inserting into the body and a proximal end adapted for receiving fluid from one or more reservoirs, said catheter comprising;

a first lumen extending from the proximal end of the catheter to the distal end of the catheter and communication to the exterior of the catheter near the distal end;

an outer layer and an insulating layer disposed within the outer layer, said insulating layer surrounding the first lumen; and

a layer located between the insulation layer and the catheter wall.

2. The catheter system of claim 1 wherein the insulating layer comprises:

a fluid having a high heat capacity.

3. The catheter system of claim 1 wherein the insulating layer comprises foam.

4. The catheter system of claim 1 wherein the insulating layer comprises a thermoplastic material.

5. The catheter system of claim 1 wherein the insulating layer comprises a thermosetting material.

6. The catheter system of claim 1 wherein the insulating layer comprises polyurethane foam.

7. The catheter system of claim 1 wherein the insulating layer comprises silicone foam.

8. The catheter system of claim 1 wherein the insulating layer comprises polyvinyl alcohol foam.

9. The catheter system of claim 1 wherein the insulating layer comprises paper.

10. The catheter system of claim 1 wherein the insulating layer comprises cellulose.

11. The catheter system of claim 1 wherein the insulating layer comprises windings of material having a high heat capacity.

12. The catheter system of claim 1 wherein the insulating layer comprises windings of material chosen from the group of polyurethane, silicone, polyvinyl alcohol, polyurethane foam, silicone foam, polyvinyl alcohol foam, paper, or cellulose.

13. The catheter system of claim 1 further comprising:

a reservoir of therapeutic material having a first viscosity at body temperature and a second viscosity at room temperature; and

means for injecting the therapeutic material from the reservoir into the first lumen.

14. The catheter system of claim 13 wherein the therapeutic material Comprises a thermally sensitive gelling material.

15. The catheter system of claim 13 wherein the therapeutic material comprises a reverse-thermal gel.

16. The catheter system of claim 13 wherein the therapeutic material comprises a thermal gel.

17. The catheter system of claim 13 wherein the therapeutic material comprises a thermally sensitive gelling material.

18. The catheter system of claim 13 wherein the layer located between the insulation layer and The catheter is comprised of stainless steel mesh.

19. The catheter system of claim 1 wherein:

the insulating layer comprises a second lumen located proximate the first lumen, said lumen extending from the proximal end of the catheter toward the distal end of the catheter, said lumen being adapted to receive a fluid from the proximal end of the catheter.

20. The catheter system of claim 19 further comprising:

a reservoir of the thermally insulating fluid; and

means for injecting the thermally insulating fluid from the reservoir into the second lumen.

21. The catheter system of claim 20 wherein the second lumen is coaxially disposed about the first lumen.

22. The catheter system of claim 20 wherein the second lumen is open to the exterior of the catheter near the distal end of the catheter.

23. The catheter system of claim 20 further comprising a third lumen in fluid communication with the second lumen near the distal end of the second lumen, said third lumen extending proximally to the proximal end of the catheter.

24. The catheter system of claim 23 wherein the third lumen is coaxially disposed about the first lumen.

25. The catheter system of claim 19 wherein the thermally insulating fluid reservoir is filled with saline maintained a temperature different than body temperature.

26. The catheter system of claim 19 wherein the second lumen is coaxially disposed about the first lumen.

27. The catheter system of claim 19 wherein the second lumen is open to the exterior of the catheter near the distal end of the catheter.

28. A catheter system for injecting a therapeutic agent into a target site within the body of a patient, wherein the therapeutic agent is a reverse-thermal gel, said catheter system comprising:

a catheter having a distal end adapted for inserting into the body and a proximal end adapted for receiving fluid from one or more reservoirs, said catheter comprising;

a first lumen extending from the proximal end of the catheter to the distal end of the catheter and communication to the exterior of the catheter near the distal end;

an outer layer and an insulating layer disposed within the outer layer, said insulating layer surrounding the first lumen; and

a layer located between the insulation layer and the catheter wall; and

a reservoir of therapeutic agent comprising a reverse thermal gel, said reservoir adapted for fluid communication with the first lumen.

29. The catheter system of claim 28 wherein the insulating layer comprises foam.

30. The catheter system of claim 28 wherein the insulating layer comprises a thermoplastic material.

31. The catheter system of claim 28 wherein the insulating layer comprises a thermosetting material.

32. The catheter system of claim 28 wherein the insulating layer comprises polyurethane foam.

33. The catheter system of claim 28 wherein the insulating layer comprises silicone foam.

34. The catheter system of claim 28 wherein the insulating layer comprises polyvinyl alcohol foam.

35. The catheter system of claim 28 wherein the insulating layer comprises paper.

36. The catheter system of claim 28 wherein the insulating layer comprises cellulose.

37. The catheter system of claim 28 wherein the insulating layer comprises windings of material having a high heat capacity.

38. The catheter system of claim 28 wherein the insulating layer comprises windings of material chosen from the group of polyurethane, silicone, polyvinyl alcohol, polyurethane foam, silicone foam, polyvinyl alcohol foam, paper, or cellulose.