TWO BALLOON CATHETERS FOR ASPIRATION AND CONTROLLED DELIVERY OF CLOSURE AGENTS
Balloon based therapy devices for treatment of diseased vessels with particular applicability to veins are described. The devices are adapted for active aspiration of a closure zone, in particular aspects to an isolated 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. The devices may also include mechanical abrasion elements adapted to engage with a vessel wall, such as along a treatment zone.
1 . (canceled)
2 . A device for treatment of an incompetent vein, comprising:
a catheter shaft having a longitudinal axis, a proximal end and a distal end;
a hub coupled to the proximal end;
a distal balloon on the catheter shaft adjacent to the distal end and a proximal balloon on the catheter shaft proximal to the distal balloon;
an atraumatic tip on the distal end;
an aperture in the catheter shaft proximal to the distal balloon and distal to the proximal balloon;
an inflation lumen within the catheter shaft in fluid communication with an interior volume of the distal balloon, an interior volume of the proximal 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
at least one coil, wherein the at least one coil has a proximal terminal end and a distal terminal end, wherein the at least one coil is arranged on the distal balloon, further wherein the at least one coil has a tissue engagement zone between its distal terminal end and its proximal terminal end, wherein, in use, partial inflation of the distal balloon to a mechanical treatment volume causes the tissue engagement zone to come into contact with a vein wall of the incompetent vein, further wherein the mechanical treatment volume is less than a volume of the distal balloon in a fully inflated occlusion state.
3 . The device of claim 2 , wherein the distal terminal end is attached to the catheter shaft using a distal collar and the proximal terminal end is attached to the catheter shaft using a proximal collar.
4 . The device of claim 2 , wherein the at least one coil has a diameter between 0.08 mm and 0.2 mm.
5 . The device of claim 2 , wherein a length of the at least on coil between its proximal terminal end and its distal terminal end is between 70 mm and 180 mm.
6 . The device of claim 2 , wherein a shape of the aperture is one of a circle, an oval, a rounded rectangular, an elongated rectangular, a narrow slot, or a slit.
7 . The device of claim 2 , wherein the incompetent vein is a gonadal vein, an internal iliac vein, or veins that branch off of the internal iliac or gonadal veins.
8 . The device of claim 2 , wherein coming into contact with the vein wall of the incompetent vein comprises injuring the endothelial layer and/or loss of endothelial cells of the incompetent vein using the tissue engagement zone of the at least one coil.
9 . The device of claim 2 , wherein the tissue engagement zone comprises an undulating segment over the distal balloon.
10 . The device of claim 9 , wherein, during the partial inflation of the distal balloon, a non-linear shape of at least a portion of the undulating segment is maintained.
11 . A device for treatment of an incompetent vein, comprising:
a catheter shaft having a longitudinal axis, a proximal end and a distal end;
a hub coupled to the proximal end;
a distal balloon on the catheter shaft adjacent to the distal end and a proximal balloon on the catheter shaft proximal to the distal balloon, wherein the distal and proximal balloons are compliant balloons adapted and configured for use in the incompetent vein;
an atraumatic tip on the distal end;
an aperture in the catheter shaft proximal to the distal balloon and distal to the proximal balloon;
an inflation lumen within the catheter shaft in fluid communication with an interior volume of the distal balloon, an interior volume of the proximal 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
at least one coil, wherein the at least one coil has a proximal terminal end and a distal terminal end, wherein the at least one coil is arranged on the distal balloon, further wherein the at least one coil has a tissue engagement zone between its distal terminal end and its proximal terminal end, wherein, in use, partial inflation of the distal balloon to a mechanical treatment volume causes the tissue engagement zone to come into contact with a vein wall of the incompetent vein, further wherein the mechanical treatment volume is less than a volume of the distal balloon in a fully inflated occlusion state.
12 . The device of claim 11 , wherein the distal terminal end is attached to the catheter shaft using a distal collar and the proximal terminal end is attached to the catheter shaft using a proximal collar.
13 . The device of claim 11 , wherein the at least one coil has a diameter between 0.08 mm and 0.2 mm.
14 . The device of claim 11 , wherein a length of the at least on coil between its proximal terminal end and its distal terminal end is between 70 mm and 180 mm.
15 . The device of claim 11 , wherein a shape of the aperture is one of a circle, an oval, a rounded rectangular, an elongated rectangular, a narrow slot, or a slit.
16 . The device of claim 11 , wherein the incompetent vein is a gonadal vein, an internal iliac vein, or veins that branch off of the internal iliac or gonadal veins.
17 . The device of claim 11 , wherein coming into contact with the vein wall of the incompetent vein comprises injuring the endothelial layer and/or loss of endothelial cells of the incompetent vein using the tissue engagement zone of the at least one coil.
18 . The device of claim 11 , wherein the tissue engagement zone comprises an undulating segment over the distal balloon.
19 . The device of claim 18 , wherein, during the partial inflation of the distal balloon, a non-linear shape of at least a portion of the undulating segment is maintained.
20 . 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 distal balloon on the catheter shaft adjacent to the distal end and a proximal balloon on the catheter shaft proximal to the distal balloon;
an aperture in the catheter shaft proximal to the distal balloon and distal to the proximal balloon;
an inflation lumen within the catheter shaft in fluid communication with an interior volume of the distal balloon, an interior volume of the proximal 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
at least one coil, wherein the at least one coil has a proximal terminal end and a distal terminal end, wherein the at least one coil is arranged on the distal balloon, wherein, in use, partial inflation of the distal balloon to a mechanical treatment volume causes the at least one coil to come into contact with a vein wall, further wherein the mechanical treatment volume is less than a volume of the distal balloon in a fully inflated occlusion state.
21 . The vein treatment device of claim 20 , wherein the distal terminal end is attached to the catheter shaft using a distal collar and the proximal terminal end is attached to the catheter shaft using a proximal collar.