IP Library Patent Application 18588474
Patent Application
App. No. 18/588,474

CATHETERS AND RELATED METHODS FOR THE ASPIRATION CONTROLLED DELIVERY OF CLOSURE AGENTS

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Quick Facts
Patent No.
US None
App. No.
18/588,474
Abstract

Balloon based therapy devices for treatment of diseased vessels are described. The devices are adapted for active aspiration of a closure zone prior to delivery of a closure agent. The devices may be used for treatment of diseased veins in the lower limbs and pelvis.

Claims (59)

1 . A method for closing a portion of a diseased vein in a patient, comprising:

accessing a portion of a venous vasculature of the patient with a balloon therapy device;

advancing the balloon therapy device into a portion of the diseased vein;

forming a proximal end of a closure zone in the diseased vein by partially inflating the balloon to a mechanical treatment volume for engagement with an inner wall of the diseased vein;

while maintaining the balloon at the mechanical treatment volume, advancing the balloon therapy device along the diseased vein to a distal end of a closure zone;

inflating the balloon to occlude the diseased vein;

while occluding the diseased vein, aspirating a portion of fluid from within the closure zone;

injecting a closure agent into the closure zone; and

maintaining occlusion in the diseased vein until a closure agent dwell time has elapsed.

2 . The method of claim 1 , further comprising:

deflating the balloon; and

withdrawing the balloon therapy device from the patient.

3 . The method of claim 1 , wherein advancing the balloon therapy device along the diseased vein to a distal end of the closure zone comprising injuring the endothelial layer and/or loss of endothelial cells of the diseased vein along the closure zone.

4 . (canceled)

5 . The method of claim 1 , wherein after the step of injecting a closure agent into the closure zone performing a step of applying a force from outside of the treatment zone to distribute the closure agent along the treatment zone.

6 . (canceled)

7 . The method of claim 5 , wherein the step of applying a force from outside of the treatment zone distributes the closure agent towards the proximal end of the closure zone and across at least one incompetent vein.

8 . The method of claim 1 , wherein after the step of inflating the balloon to a mechanical treatment volume at least one mechanical abrasion element is positioned between a surface of the balloon and a surface of the diseased vein.

9 . (canceled)

10 . A method for closing a portion of a diseased vein in a patient, comprising:

accessing a portion of a venous vasculature of the patient with a balloon therapy device;

advancing the balloon therapy device into a portion of the diseased vein;

forming a proximal end of a closure zone in the diseased vein by partially inflating the balloon to a mechanical treatment volume for engagement with an inner wall of the diseased vein, wherein when the balloon is filled to the mechanical treatment volume within the diseased vein a length of the balloon along the diseased vein is greater than the width of the balloon across the diseased vein;

while maintaining the balloon at the mechanical treatment volume, advancing the balloon therapy device along the diseased vein to a distal end of the closure zone;

inflating the balloon to an occlusion volume causing the balloon to occlude the diseased vein at a distal end of a closure zone;

while maintaining the balloon at the occlusion volume, aspirating a portion of fluid from within the closure zone;

injecting a closure agent into the closure zone; and

maintaining the balloon at the occlusion volume until a closure agent dwell time has elapsed.

11 . The method of claim 10 , further comprising:

deflating the balloon; and

withdrawing the balloon therapy device from the patient.

12 . The method of claim 10 , wherein advancing the balloon therapy device along the diseased vein to a distal end of the closure zone comprises injuring only a portion of an endothelium of the diseased vein along the closure zone.

13 . (canceled)

14 . A method for closing a portion of a diseased vein in a patient, comprising:

accessing a portion of a venous vasculature of the patient with a balloon therapy device, wherein the balloon is compliant;

advancing the balloon therapy device into a portion of the diseased vein;

inflating the balloon into a cylindrical shape at a proximal end of a closure zone to transition a mechanical abrasion structure from a stowed configuration into a partially deployed configuration in contact with a wall of the diseased vein;

while maintaining the mechanical abrasion structure in the partially deployed configuration, advancing the balloon therapy device along the diseased vein to a distal end of a closure zone;

inflating the balloon to occlude the diseased vein while aspirating a portion of fluid from within the closure zone;

injecting a closure agent into the closure zone after aspirating a portion of the fluid within the closure zone; and

continuing to occlude the diseased vein with the balloon until a closure agent dwell time has elapsed.

15 . The method of claim 14 , further comprising:

deflating the balloon to return the mechanical abrasion structure to a stowed configuration; and

withdrawing the balloon therapy device from the patient.

16 . (canceled)

17 . (canceled)

18 . The method of claim 14 , wherein when the mechanical abrasion structure is in the partially deployed configuration one or more tissue engagement elements contact a wall of the diseased vein.

19 . The method of claim 14 , wherein the closure agent dwell time is from 2-5 minutes and the elapsed time from performing the step of advancing the balloon therapy device into a portion of the diseased vein to completing the step of withdrawing the balloon therapy device from the patient is less than 10 minutes.

20 . (canceled)

21 . The method of claim 14 , wherein advancing the balloon therapy device along the diseased vein to a distal end of a closure zone comprises injuring the endothelial layer and/or loss of endothelial cells of the diseased vein along the closure zone.

22 . The method of claim 14 , wherein the step of aspirating a portion of fluid from within the closure zone is performed using an aperture proximal to the balloon.

23 . The method of claim 22 , wherein the step of injecting a closure agent into the closure zone is performed using the aperture.

24 . (canceled)

25 . The method of claim 14 , further comprising performing the injecting a closure agent step using a connector.

26 . The method of claim 14 , wherein the closure zone is within a vein in a leg of the patient.

27 . (canceled)

28 . (canceled)

29 . The method of claim 14 , wherein inflating the balloon to transition a mechanical abrasion structure from a stowed configuration into a partially deployed configuration comprises moving a portion of at least one mechanical abrasion element of the mechanical abrasion structure proximally along a dedicated mechanical abrasion element lumen of the balloon therapy device.

30 . The method of claim 14 , wherein advancing the balloon therapy device along the diseased vein to a distal end of a closure zone comprises advancing the balloon therapy device past at least one incompetent valve in the diseased vein.

Assignments (2)
CHANGE OF NAME Recorded Mar 4, 2025
From: CONTROLLED DELIVERY SYSTEM, INC.
To: SOLVEIN INC.
Reel/Frame 070403/0304 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 29, 2024
From: GOLSHAN, ALI
To: CONTROLLED DELIVERY SYSTEMS, INC.
Reel/Frame 069063/0699 →