Methods for minimally invasive, localized delivery of sclerotherapeutic agents

• US 6,726,674 B2
• Filed: 09/04/2001
• Issued: 04/27/2004
• Est. Priority Date: 09/04/2001
• Status: Expired due to Fees

• Current Assignee: Anders J. Leu
• Original Assignee: Jomed GmbH
• Inventors: Leu, Anders J.
• Primary Examiner(s): Thanh, LoAn H.
• Application Number:
  US09/944,143
• Publication Number:
  US 20030045860A1
• Time in Patent Office: 966 Days
• Field of Search: 604/500, 604/507-509, 604/96.01, 604/101-1-1, 604/103.01, 604/103.02, 604/103.06, 604/103.07, 604/915, 606/192, 606/194
• US Class Current: 604/101.01
• 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 2025/1072 having balloons with two or more compartments
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence

Abstract

Apparatus and methods are provided for localized, minimally invasive administration of sclerotherapy in the treatment of varicose veins. A treatment site within a vein is isolated from blood flow through the vain. Sclerotherapeutic agents are delivered to the isolated vessel segment. A substantial portion of the agents are then removed from the vein, and isolation is removed from the treatment site. Inflammation, clotting, scarring, and closure of the varicose vein ensues at the treatment site. In a preferred embodiment, this technique is accomplished with a catheter having an inflatable member. The inflatable member is expandable to a deployed configuration in which its central region is of reduced cross-section as compared to its proximal and distal regions. The central region comprises one or more perforations extending through the inflatable member so that sclerotherapeutic agents may be delivered through the perforations.

Claims

1. A method of administering sclerotherapy to a varicose vein, the method comprising:

isolating a segment of the varicose vein from blood flow through the vein;

delivering sclerotherapeutic agents to the isolated segment, thereby initiating occlusion of the vein;

removing from the varicose vein a substantial portion of the sclerotherapeutic agents delivered to the isolated segment; and

then

removing isolation from the vein segment.

2. The method of claim 1, wherein the substantial portion comprises a majority of the sclerotherapeutic agents delivered to the isolated segment.

3. The method of claim 1, wherein the sclerotherapeutic agents are chosen from the group consisting of hypertonic saline, sodium tetradecyl sulfate, and aethoxyskerol.

4. The method of claim 1, wherein isolating the segment of the varicose vein comprises expanding first and second inflatable members proximal and distal of the vein segment, respectively.

5. A method of administering sclerotherapy to a varicose vein, the method comprising:

providing an apparatus comprising a catheter and a inflatable member, the catheter having an inflation lumen coupled to the inflatable member;

the inflatable member reversibly expandable from a collapsed, delivery configuration to an expanded, deployed configuration, the inflatable member having proximal and distal regions, and a central region disposed therebetween;

the central region having a reduced cross-section, as compared to the proximal and distal regions, in the deployed configuration, the central region further comprising at least one perforation extending through the inflatable member;

isolating a segment of the varicose vein from blood flow through the vein by expanding the inflatable member from the delivery configuration to deployed configuration;

delivering sclerotherapeutic agents to the isolated segment through the at least one perforation, thereby initiating occlusion of the vein removing a substantial portion of the sclerotherapeutic agents delivered to the isolated segment; and

then

removing isolation from the vein segment.

6. The method of claim 5, wherein

expanding the inflatable member comprises sealingly engaging an interior surface of the varicose vein proximally and distally of the vein segment with the proximal and distal regions of the inflatable member, respectively.

7. The method of claim 5, wherein

expanding the inflatable member comprises injecting sclerotherapeutic agents through the inflation lumen of the catheter.

8. The method of claim 5, wherein

delivering sclerotherapeutic agents to the isolated segment comprises injecting an additional volume of the sclerotherapeutic agents through the inflation lumen after the inflatable member has been expanded to the deployed configuration, thereby causing a portion of the sclerotherapeutic agents to pass through the at least one perforation in the central region of the inflatable member.

9. The method of claim 5, wherein

removing isolation from the vein segment comprises collapsing the inflatable member back to the delivery configuration.

10. The method of claim 9, wherein

collapsing the inflatable member back to the delivery configuration comprises removing the sclerotherapeutic agents form the inflatable member through the inflation lumen.

11. The method of claim 9 further comprising

removing the apparatus from the varicose vein.

12. The method of claim 5 further comprising,

prior to removing isolation from the vein segment, removing from the varicose vein a substantial portion of the sclerotherapeutic agents delivered to the isolated segment.

13. The method of claim 12, wherein

removing the substantial portion of the sclerotherapeutic agents comprises removing the agents from the isolated segment through the at least one perforation and through the inflation lumen.

14. The method of claim 5, wherein the catheter further comprises a guide wire lumen, and wherein isolating the vein segment further comprises:

prior to expanding the inflatable member, advancing a guide wire to the vein segment using well-known percutaneous techniques; and

advancing the catheter over the guide wire to the vein segment via the guide wire lumen.

15. The method of claim 5, wherein the apparatus further comprises an infusion lumen coupled to the at least one perforation extending through the inflatable member, and wherein delivering sclerotherapeutic agents to the isolated segment comprises injecting sclerotherapeutic agents through the infusion lumen.

16. A The method of claim 15, wherein

removing the substantial portion of the sclerotherapeutic agents comprises removing the agents from the isolated segment through the at least one perforation and through the infusion lumen.

17. The method of claim 5, wherein the apparatus further comprises an additional lumen extending axially across the inflation lumen to allow blood to flow therethrough.

18. The method of claim 17 further comprising

maintaining blood flow through the varicose vein while the vein segment is isolated by flowing the blood through the additional lumen.