CATHETERS AND RELATED METHODS FOR THE ASPIRATION CONTROLLED DELIVERY OF CLOSURE AGENTS
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.
1 . A vein treatment device, comprising:
a catheter shaft having 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, wherein the distal balloon is a compliant balloon;
an aperture in the catheter shaft proximal to the distal balloon;
an inflation lumen within the catheter shaft in fluid communication with an interior volume of the distal 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
a plurality of mechanical abrasion elements spaced about the surface of the catheter shaft and extending along the distal balloon, each mechanical abrasion element of the plurality of mechanical abrasion elements comprises a tissue contacting surface and a distal balloon contacting surface, a proximal terminal end and a distal terminal end wherein the proximal terminal end of each of the mechanical abrasion elements is coupled to the catheter shaft proximal to the aperture in the catheter shaft proximal to the distal balloon and the distal terminal end of each of the mechanical abrasion elements is coupled to the catheter shaft distal to a distal most end of the distal balloon.
2 . The vein treatment device of claim 1 , wherein the plurality of mechanical abrasion elements is arranged circumferentially around the distal balloon.
3 . The vein treatment device of claim 2 , wherein the plurality of mechanical abrasion elements is arranged evenly around the distal balloon.
4 . The vein treatment device of claim 1 , wherein each mechanical abrasion element forms a curve from a proximal end of the distal balloon to a distal end of the distal balloon.
5 . The vein treatment device of claim 1 , wherein the plurality of mechanical abrasion elements comprises a plurality of coils, wherein each coil extends from a proximal end of the balloon to a distal end of the distal balloon.
6 . The vein treatment device of claim 5 , wherein each coil is a partial coil.
7 . The vein treatment device of claim 1 , wherein the plurality of mechanical abrasion elements comprises a plurality of rings, wherein each ring extends from a proximal end of the distal ballon to a distal end of the distal balloon.
8 . The vein treatment device of claim 1 , further comprising a proximal collar arranged around the catheter shaft to secure each of the proximal terminal ends of each of the plurality of mechanical abrasion elements to the catheter shaft and a distal collar arranged around the catheter shaft to secure each of the distal terminal ends of each of the plurality of mechanical abrasion elements to the catheter shaft.
9 . The vein treatment device of claim 1 , wherein each mechanical abrasion element further comprises an undulating segment extending along the distal balloon.
10 . The vein treatment device of claim 1 , wherein the number of individual mechanical abrasion elements in the plurality of mechanical abrasion elements is 3, 4, 5, 6, 7 or 8.
11 . The vein treatment device of claim 1 , wherein each mechanical abrasion element of the plurality of mechanical abrasion elements has a diameter between 0.1 mm to 0.6 mm.
12 . The vein treatment device of claim 1 , wherein the length of the distal balloon is from 16 mm to 30 mm or from 18 mm to 28 mm or from 20 mm to 26 mm.
13 . The vein treatment device of claim 1 , the hub further comprising a standard medical connector on the inflation port and a standard medical connector on the fluid port, wherein each of the standard medical connectors is one of a Luer connector, a screw on connector or a locking valve.
14 . A vein treatment device, comprising:
a catheter shaft having 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
a plurality of mechanical abrasion elements arranged about the compliant balloon, each of the mechanical abrasion elements comprising a distal terminal end, a proximal terminal end and a tissue engagement zone directly adjacent to an outer surface of the compliant balloon, wherein in use a partial inflation of the compliant balloon causes the tissue engagement zone of each of the plurality of mechanical abrasion elements to come into contact with a vein wall of the vein, further wherein the length of each one of the plurality of the mechanical abrasion elements has a length between the proximal terminal end and the distal terminal end of between 70 mm and 180 mm.
15 . The vein treatment device of claim 14 , wherein each tissue engagement zone of each of the plurality of mechanical abrasion elements further comprises a non-straight segment over the compliant balloon between each proximal terminal end and each distal terminal end.
16 . The vein treatment device of claim 14 , wherein each tissue engagement zone of each of the plurality of mechanical abrasion elements further comprises a curved segment over the compliant balloon.
17 . The vein treatment device of claim 16 , wherein, during the partial inflation of the compliant balloon, at least a portion of the curved segment is maintained.
18 . The vein treatment device of claim 14 , wherein each tissue engagement zone of each of the plurality of mechanical abrasion elements further comprises an undulating segment over the compliant balloon.
19 . The vein treatment device of claim 18 , wherein, during partial inflation of the compliant balloon, at least a portion of the undulating segment is maintained.
20 . The vein treatment device of claim 14 , wherein each distal terminal end of each mechanical abrasion element is attached to the catheter shaft distal to a distal most portion of the compliant balloon.
21 . The vein treatment device of claim 14 , wherein each proximal terminal end of each mechanical abrasion element is attached to the catheter shaft proximal to a proximal most portion of the compliant balloon.
22 . The vein treatment device of claim 14 , wherein the number of individual mechanical abrasion elements in the plurality of mechanical abrasion elements is 3, 4, 5, 6, 7 or 8.
23 . The vein treatment device of claim 14 , wherein each mechanical abrasion element of the plurality of mechanical abrasion elements has a diameter between 0.1 mm to 0.6 mm and the length of the complaint balloon is from 16 mm to 30 mm or from 18 mm to 28 mm or from 20 mm to 26 mm.
24 . The vein treatment device of claim 14 , wherein the number of individual mechanical abrasion elements in the plurality of mechanical abrasion elements is 4 and each individual mechanical abrasion element is a coil.