Drug Coated Balloon Catheter

• US 20090254063A1
• Filed: 02/13/2009
• Published: 10/08/2009
• Est. Priority Date: 07/13/2007
• Status: Active Grant

• Current Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories)
• Original Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories)
• Inventors: Ehrenreich, Kevin J., Yribarren, Travis R., Webler, William E. JR., Newhauser, Richard R., Oepen, Randolf von
• Granted Patent: US 8,617,114 B2
• Time in Patent Office: Days
• US Class Current: 604/509
• CPC Class Codes: A61M 2025/1015 having two or more independently movable balloons where the distance between the balloons can be adjusted, e.g. two balloon catheters concentric to each other forming an adjustable multiple balloon catheter system
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2025/1081 having sheaths or the like for covering the balloon but not forming a permanent part of the balloon, e.g. retractable, dissolvable or tearable sheaths
• CPC Class Codes: A61M 25/1006 Balloons formed between concentric tubes

Abstract

The present invention relates to balloon catheters for treating a luminal system of a patient. Specifically, the invention relates to catheters having a flexible membrane positioned at a distal portion of the catheter, the flexible membrane retained in a substantially unexposed conformation prior to deployment. Preferably the flexible membrane is capable of delivering a therapeutic agent to a localized environment when deployed to an exposed conformation.

Claims

1. A balloon catheter comprising:

an inner shaft member having a proximal end portion, a distal end portion, and a length therebetween;

an outer shaft member movable relative to the inner shaft member having a proximal end portion, a distal end portion, and a length therebetween;

an annular flow passage disposed between the inner and outer shaft members;

a flexible membrane extending between the distal end portion of the inner shaft member and the distal end portion of the outer shaft member;

wherein the flexible membrane includes an inner surface and an outer surface, the inner surface configured in fluid communication with the annular flow passage; and

wherein the flexible membrane includes a therapeutic agent disposed thereon.

2. The balloon catheter of claim 1 wherein the outer shaft member is axially movable relative to the inner shaft member.

3. The balloon catheter of claim 2 including a bellows component disposed at the proximal end portion of the outer shaft member to maintain a sealed environment of the annular flow passage during movement of the outer shaft relative to the inner shaft.

4. The balloon catheter of claim 2 including a dynamic seal disposed between the inner shaft member and the outer shaft member to maintain a sealed environment of the annular flow passage during movement of the outer shaft relative to the inner shaft.

5. The balloon catheter of claim 1 wherein the outer shaft member and the inner shaft member define a chamber configured to receive the flexible membrane therein.

6. The balloon catheter of claim 5 wherein the outer surface of the flexible membrane is attached to the inner surface of the outer shaft member and the outer surface of the flexible membrane is attached to the outer surface of the inner shaft member.

7. The balloon catheter of claim 1 wherein the outer shaft member is rotatably movable relative to the inner shaft member.

8. The balloon catheter of claim 7 including a dynamic seal disposed between the inner shaft member and the outer shaft member to maintain a sealed environment of the annular flow passage during movement of the outer shaft relative to the inner shaft.

9. The balloon catheter of claim 7 wherein, in a pre-deployed condition, the flexible membrane includes spiral formations.

10. The balloon catheter of claim 1 including a retrieval element attached to the inner shaft member.

11. A balloon catheter comprising:

an inner shaft member having a proximal end portion, a distal end portion, and a length therebetween;

an outer shaft member movable relative to the inner shaft member having a proximal end portion, a distal end portion, and a length therebetween;

an annular flow passage disposed between the inner and outer shaft members;

a flexible membrane extending between the distal end portion of the inner shaft member and the distal end portion of the outer shaft member;

wherein the flexible membrane includes an inner surface and an outer surface, the inner surface configured in fluid communication with the annular flow passage; and

wherein the flexible membrane includes at least one driver segment and a delivery segment, wherein the driver segment defines at least a portion of a chamber configured to receive the delivery segment; and

wherein the driver segment is constructed of a material having different compliance than that of the delivery segment.

12. The balloon catheter of claim 11 wherein the flexible membrane includes a proximal driver segment, a distal driver segment, and a delivery segment therebetween.

13. The balloon catheter of claim 12 wherein the proximal driver segment and the distal driver segment enfold the delivery segment to define the chamber configured to receive the delivery segment.

14. A method of treating a luminal system of a patient comprising:

providing a balloon catheter including;

an inner shaft member having a proximal end portion, a distal end portion, and a length therebetween;

an outer shaft member movable relative to the inner shaft member having a proximal end portion, a distal end portion, and a length therebetween, with an annular flow passage disposed between the inner and outer shaft members;

a flexible membrane extending between the distal end portion of the inner shaft member and the distal end portion of the outer shaft member, the flexible membrane having an inner surface and an outer surface with the inner surface in fluid communication with the annular flow passage; and

a therapeutic agent disposed on the flexible membrane;

positioning the balloon catheter at a desired deployment site;

moving the outer shaft member relative to the inner shaft member; and

introducing inflation fluid into the annular flow passage, simultaneously or sequentially with said relative movement, to deploy the flexible membrane into an expanded configuration to treat the luminal system of a patient.

15. The method of claim 14 wherein initial deployment of the flexible membrane at least partially occludes the luminal system of the patient prior to full expansion of the flexible membrane.

16. The method of claim 14 wherein the flexible membrane, in a pre-deployment state, includes spiral formations and deployment is accomplished by rotational movement of the outer shaft member relative to the inner shaft member.

17. The method of claim 14 wherein the flexible membrane is collapsed after deployment and treatment of the luminal system of the patient.

18. The method of claim 17 wherein the flexible membrane is collapsed by withdrawing inflation fluid from the annular flow passage

19. The method of claim 17 wherein the flexible membrane is collapsed by movement of the outer shaft member axially relative to the inner shaft member.

20. The method of claim 17 wherein the flexible membrane is repositioned upon collapse into a chamber configured to receive the flexible membrane, wherein the chamber is defined by the outer shaft member and the inner shaft member.