Vascular ablation apparatus and method

• US 7,862,575 B2
• Filed: 12/17/2003
• Issued: 01/04/2011
• Est. Priority Date: 05/21/2003
• Status: Active Grant

• Current Assignee: Yale University
• Original Assignee: Yale University
• Inventors: Tal, Michael G.
• Primary Examiner(s): Jackson; Gary
• Assistant Examiner(s): NGUYEN, VI X
• Application Number:
  US10/736,535
• Publication Number:
  US 20050055040A1
• Time in Patent Office: 2,575 Days
• Field of Search: 604/96.01, 604/508, 604/101.1, 604/509, 606/159, 606/192, 606/194, 606/170, 606/139, 606/153, 128/898
• US Class Current: 606/159
• CPC Class Codes: A61B 17/00008 Vein tendon strippers tube strippers A61M1/83
• CPC Class Codes: A61B 17/3207 Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions A61B17/32037 takes precedence; endoscopic cutting instruments A61B17/320016
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 17/320758 with a rotating cutting instrument, e.g. motor driven A61B17/320725, A61B17/32075 and A61B17/320783 take precedence; for removing intra-ocular material A61F9/00763; endoscopic rotatable cutting instruments A61B17/32002
• CPC Class Codes: A61B 2017/00778 Operations on blood vessels A61B2017/22097, A61B2017/320741 take precedence
• CPC Class Codes: A61B 2017/320004 abrasive
• CPC Class Codes: A61B 2017/320012 Brushes
• CPC Class Codes: A61B 2017/320733 with a flexible cutting or scraping element, e.g. with a whip-like distal filament member

Abstract

An apparatus for the treatment of venous stasis includes an elongated intraluminal member shaped and dimensioned for passage through vessels of a subject. The intraluminal member includes a proximal end and a distal end. A conduit extends from proximate the proximal end of the intraluminal member to proximate the distal end of the intraluminal member. The conduit is shaped and dimensioned for fluid communication between the proximal end of the intraluminal member and the distal end of the intraluminal member. The distal end of the intraluminal member includes disruption means proximate thereto for ablating a predetermined vessel wall. A method is also provided for the treatment of venous stasis. The method is achieved by advancing an elongated intraluminal member through a vein to a treatment site, activating the intraluminal member for ablation of the treatment site and injecting sclerosant into the vein at the treatment site.

Claims

1. A method for permanently occluding a vein through the combined disruption of a vein vessel wall and application of a sclerosant, comprising the following steps:

advancing an elongated intraluminal member from an access site and into the vein, wherein the intraluminal member has a portion thereof configured to produce damage to an inner vessel wall of the vein under user control when performing a defined movement;

damaging the inner vessel wall by performing the defined movement of the portion of the intraluminal member configured to produce damage against the vein'"'"'s endothelium to disrupt the endothelium and ensure it is damaged and rendered susceptible to sclerosant; and

injecting sclerosant into the vein and onto the damaged inner vessel wall;

wherein the steps of damaging and injecting damages an extended portion of the inner vessel wall and exposes the extended portion to the sclerosant; and

wherein the damage to the inner vessel wall comprises destruction and disruption of the endothelium sufficient to;

(1) enhance the effect of the sclerosant, (2) facilitate the destruction of the vein, and (3) increase the likelihood of permanent vein occlusion from the injected sclerosant.

2. The method according to claim 1, wherein the step of moving comprises scraping the intraluminal member against the endothelium.

3. The method of claim 2, wherein the sclerosant is injected during scraping.

4. The method according to claim 1, wherein the intraluminal member comprises a hollow infusion wire, and the sclerosant is injected into the vein through the hollow infusion wire.

5. The method according to claim 1, wherein the elongated intraluminal member is a balloon catheter.

6. The method of claim 1, further comprising withdrawing the intraluminal member through the vein toward the access site while damaging the inner vessel wall and injecting sclerosant.

7. The method of claim 1, wherein the intraluminal member is advanced through a sheath, and the sclerosant is injected into the vein through an annular space between the intraluminal member and the sheath.

8. The method of claim 1, wherein the vein has a size of 2-10 mm.

9. The method of claim 1, wherein the defined movement comprises rotating the intraluminal member in the vein under the control of a motor so that a portion of the intraluminal member engages the endothelium.

10. The method of claim 9, wherein the portion of the intraluminal member that engages the endothelium is sharpened.

11. The method of claim 1, wherein the intraluminal member curves at a distal end.

12. The method of claim 1, wherein the intraluminal member is simultaneously rotated and moved longitudinally.

13. The method of claim 1, wherein the sclerosant is injected during the defined movement.

14. The method of claim 13, wherein the intraluminal member is rotated and moved longitudinally during scraping.

15. The method of claim 13, wherein the endothelium of the vein is disrupted without perforating the vein.

16. The method of claim 1, comprising moving the intraluminal member longitudinally.