Method and apparatus for treatment of focal disease in hollow tubular organs and other tissue lumens

• US 6,287,320 B1
• Filed: 08/26/1997
• Issued: 09/11/2001
• Est. Priority Date: 02/26/1990
• Status: Expired due to Fees

• Current Assignee: Genzyme Corporation (Sanofi )
• Original Assignee: Endoluminal Therapeutics Incorporated
• Inventors: Slepian, Marvin J.
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): LEWIS, WILLIAM W
• Application Number:
  US08/918,361
• Time in Patent Office: 1,477 Days
• Field of Search: 606/191, 606/192, 606/194, 606/95, 604/96-101
• US Class Current: 606/194
• CPC Class Codes: A61L 24/0031 Hydrogels or hydrocolloids
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2025/1095 with perfusion means for enabling blood circulation while the balloon is in an inflated state or in a deflated state, e.g. permanent by-pass within catheter shaft
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters

Abstract

The present invention provides a technique for treating diseased portions of tissue lumens by the focal introduction of at least one therapeutic agent at the diseased region. A catheter is positioned in a lumen such that first and second expansile members surround the diseased portion of tissue. The expansile members are expanded to occlude the diseased region and a therapeutic agent is introduced to the occluded diseased region via the catheter. The catheter is allowed to remain in place for a therapeutically effective period of time to allow the therapeutic agent to contact the diseased portion for such a period of time. The catheter arrangement also can be used to occlude a diseased region, remove physiological fluid from the occluded region and subsequently to disrupt the diseased region and/or apply the therapeutic agent. The therapeutic agent can be selected to suppress cell proliferation in the diseased region, and the occluded region can be treated with a medicament to promote vessel healing. The occluded region also can be paved with polymeric material. Finally, the expansile members are contracted and the catheter is removed.

Claims

1. A method for providing localized therapy with a therapeutic agent to a diseased region in a tissue lumen, comprising:

(a) introducing a catheter into the tissue lumen, said catheter comprising first and second expansile members and said catheter being positioned such that said first and second expansile members are disposed on opposite sides of the diseased region;

(b) expanding the expansile members to occlude the diseased region of the tissue lumen;

(c) introducing a therapeutic agent to the occluded diseased region via the catheter;

applying a conforming polymer coating to a surface of the tissue lumen via the catheter;

allowing the catheter to remain in place for a therapeutically effective period of time;

contracting the expansile members; and

removing the catheter.

2. A method as in claim 1, wherein the polymer coating is applied to the surface from a polymer precursor.

3. A method as in claim 2, wherein the precursor is selected from the group consisting of a monomer, a prepolymer solution, and an at least partially preformed polymer product.

4. A method as in claim 3, wherein the precursor contains the therapeutic agent.

5. A method as in claim 3, wherein the precursor is introduced as an at least partially polymerized, deformable sleeve.

6. A method as in claim 1, further comprising the step of washing the occluded region to remove body fluid after the expanding step.

7. A method as in claim 1, further comprising the step of disrupting the diseased region of a tissue lumen to loosen diseased tissue after the step of introducing the therapeutic agent.

8. A method as in claim 1, wherein the therapeutic agent is selected from the group consisting of anti-thrombotic agents, thrombolytic agents, vasodilating agents, calcium channel blocking drugs, anti-proliferative agents, intercalating agents, gross modulating factors and anti-inflammatory agents.

9. A method as in claim 1, wherein the catheter has a distal region adapted for inserting into a patient and a proximal region adapted to remain outside of the patient.

10. A method as in claim 9, wherein the step of introducing the therapeutic agent further includes the step of accessing a reservoir of therapeutic agent, the reservoir being situated at the proximal region and connected with a port at the distal region via a fluid pathway.

11. A method as in claim 10, wherein the port is located between the first and second expansile members.

12. A method for providing localized therapy with a therapeutic agent to a diseased region in a tissue lumen, comprising:

introducing an elongate tubular shaft into the tissue lumen, the shaft having a distal region adapted for inserting into a patient and a proximal region adapted to remain outside of the patient;

applying a conforming polymer coating to the diseased region; and

adding a therapeutic agent to the diseased region via the shaft for a therapeutically effective period of time, wherein the therapeutic agent is selected to influence the behavior of cells and is selected from the group consisting of anti-thrombotic agents, thrombolytic agents, vasodilating agents, calcium channel blocking drugs, anti-proliferative agents, intercalating agents, gross modulating factors and anti-inflammatory agents.

13. A method as in claim 12, comprising applying the polymer coating by adding the precursor via the shaft and curing the precursor on the diseased region.

14. A method as in claim 13, further comprising the step of occluding the diseased region prior to applying the polymer coating.

15. A method as in claim 13, further comprising the step of occluding the diseased region prior to adding the therapeutic agent.

16. A method as in claim 14, further comprising the step of removing physiological fluid from the occluded diseased region.

17. A method as in claim 16, further comprising the step of disrupting the diseased region of the tissue lumen to loosen diseased tissue after removing the physiological fluid.

18. A method as in claim 13, wherein the step of contacting the diseased region with the therapeutic agent includes the step of accessing a reservoir of therapeutic agent, the reservoir being situated at the proximal region and connected with a port at the distal region via a fluid pathway.

19. A method as in claim 18, wherein the step of occluding the diseased region involves expanding first and second occlusion elements at the distal region of the shaft.

20. A method as in claim 19, wherein the port is located between the first and second occlusion elements.