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US 12,420,071 B2Granted
Catheters and related methods for the aspiration controlled delivery of closure agents
AssigneeSolvein, Inc.
InventorAli Golshan
Life of this patent
Estimating the term…
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.
Claims30
A vein treatment device, comprising:
- a catheter shaft having a longitudinal axis, a proximal end and a distal end;
- a hub coupled to the proximal end;
- a balloon on the catheter shaft adjacent to the distal end;
- an aperture in the catheter shaft proximal to the balloon;
- an inflation lumen within the catheter shaft in fluid communication with an interior volume of the balloon and an inflation port on the hub;
- a fluid lumen within the catheter shaft in fluid communication with the aperture and a fluid port on the hub;
- and
- four mechanical abrasion coils, wherein each of the four mechanical abrasion coils has a proximal terminal end and a distal terminal end, wherein each of the four mechanical abrasion coils has a diameter between 0.08 mm and 0.2 mm, wherein the four mechanical abrasion coils are arranged circumferentially around the balloon with each of the distal terminal ends attached to the catheter shaft using a distal collar and each of the proximal terminal ends attached to the catheter shaft using a proximal collar, wherein each of the distal terminal ends is in line with its respective proximal terminal end in a direction of the longitudinal axis, further wherein each of the four mechanical abrasion coils has a tissue engagement zone between its distal terminal end and its proximal terminal end, wherein, in use, partial inflation of the balloon to a mechanical treatment volume causes each of the four tissue engagement zones to come into contact with a vein wall of a vein, further wherein the mechanical treatment volume is less than a volume of the balloon in a fully inflated occlusion state.
5 more elements
A vein treatment device, comprising:
- a catheter shaft having a longitudinal axis, a proximal end and a distal end;
- a hub coupled to the proximal end;
- a compliant balloon on the catheter shaft adjacent to the distal end;
- an aperture in the catheter shaft proximal to the compliant balloon;
- an inflation lumen within the catheter shaft in fluid communication with an interior volume of the compliant balloon and an inflation port on the hub;
- a fluid lumen within the catheter shaft in fluid communication with the aperture and a fluid port on the hub;
- and
- four mechanical abrasion coils, wherein each of the four mechanical abrasion coils has a proximal terminal end and a distal terminal end, wherein the four mechanical abrasion coils are arranged around the compliant balloon with each of the distal terminal ends attached to the catheter shaft and each of the proximal terminal ends attached to the catheter shaft, wherein each of the distal terminal ends is in line with its respective proximal terminal end in a direction of the longitudinal axis, further wherein, in use, partial inflation of the compliant balloon to a mechanical treatment volume causes a portion of each of the mechanical abrasion coils to come into contact with a vein wall of a vein being treated with the vein treatment device, further wherein the mechanical treatment volume is less than a volume of the compliant balloon in a fully inflated occlusion state.
5 more elements
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 vein treatment device having a catheter shaft with a longitudinal axis, a compliant balloon on the catheter shaft, and four mechanical abrasion coils, wherein each of the four mechanical abrasion coils has a proximal terminal end and a distal terminal end, wherein the four mechanical abrasion coils are arranged circumferentially around the compliant balloon with each of the distal terminal ends attached to the catheter shaft using a distal collar and each of the proximal terminal ends attached to the catheter shaft using a proximal collar, wherein each of the distal terminal ends is in line with its respective proximal terminal end in a direction of the longitudinal axis;
- advancing the vein treatment device into a portion of the diseased vein;
- forming a proximal end of a closure zone in the diseased vein by partially inflating the compliant balloon to a mechanical treatment volume for engagement of a tissue engagement zone of each of the four mechanical abrasion coils between its distal terminal end and its proximal terminal end with an inner wall of the diseased vein;
- while maintaining the compliant balloon at the mechanical treatment volume, advancing the vein treatment device along the diseased vein to a distal end of the closure zone;
- inflating the compliant 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.
6 more elements
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 vein treatment device having a catheter shaft with a longitudinal axis, a compliant balloon on the catheter shaft, and four mechanical abrasion coils, wherein each of the four mechanical abrasion coils has a proximal terminal end and a distal terminal end, wherein the four mechanical abrasion coils are arranged around the compliant balloon with each of the distal terminal ends attached to the catheter shaft distal to the compliant balloon and each of the proximal terminal ends attached to the catheter shaft proximal to the compliant balloon, wherein each distal terminal end is in line with its respective proximal terminal end in a direction of the longitudinal axis, wherein each of the four mechanical abrasion coils has a tissue engagement zone between its distal terminal end and its proximal terminal end;
- advancing the vein treatment device into a portion of the diseased vein;
- partially inflating the compliant balloon to a mechanical treatment volume at a proximal end of a closure zone for engagement of each of the four tissue engagement zones with an inner wall of the diseased vein, such that each of the four tissue engagement zones engages an inner wall of the diseased vein;
- while maintaining the compliant balloon at the mechanical treatment volume, advancing the vein treatment device along the diseased vein to a distal end of the closure zone;
- inflating the compliant 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 the portion of the fluid within the closure zone;
- and
- continuing to occlude the diseased vein with the compliant balloon until a closure agent dwell time has elapsed.
5 more elements
Dependencies are inferred from the claim text.