CATHETERS 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 catheter shaft proximal end;
a balloon on the catheter shaft adjacent to the distal end, wherein the balloon is a compliant balloon having an inflated occlusion diameter of 4 mm to 16 mm during use within the vein;
an atraumatic tip on catheter shaft distal end;
an aspiration and injection port 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; and
a fluid lumen within the catheter shaft in fluid communication with the aspiration and injection port and a fluid port on the hub;
a pair of mechanical abrasion elements extending along the catheter shaft and over the balloon, each of the pair of the mechanical abrasion elements having a tissue contacting surface and a balloon contacting surface, wherein at least a first section of each of the pair of the mechanical abrasion elements is configured to translate axially relative to the catheter shaft, and wherein inflation of the balloon below 3 cc during use inside the vein causes at least a second section of each of the pair of the mechanical abrasion elements to extend away from the catheter shaft into contact with the vein.
2 . The device of claim 1 , wherein the first section is proximal to the balloon and each mechanical abrasion element of the pair of mechanical abrasion elements comprises a distal end coupled to the catheter shaft at a location distal to the balloon.
3 . The device of claim 1 , wherein the first section is distal to the balloon and each of the mechanical abrasion elements in the pair of mechanical abrasion elements comprises a proximal end coupled to the catheter shaft at a location proximal to the balloon.
4 . The device of claim 1 , the catheter shaft further comprising a pair of mechanical abrasion element lumens, each one of the pair of mechanical abrasion element lumens formed in a sidewall of the catheter shaft positioned and sized to receive and guide axial movement of the first section of each of the mechanical abrasion elements relative to the catheter shaft.
5 . The device of claim 4 , further comprising a pair of apertures in the catheter shaft in communication with each of the mechanical abrasion element lumens wherein in use the second section of each one of the pair of the mechanical abrasion elements extends from the balloon along the catheter shaft and into the respective aperture of each one of the pair of the mechanical abrasion element lumens.
6 . The device of claim 5 , wherein inflation of the balloon causes the first section of each of the mechanical abrasion elements positioned within the catheter shaft to slide distally and move through the aperture and outside the catheter shaft.
7 . The device of claim 5 , wherein deflation of the balloon causes the first section of each of the mechanical abrasion elements positioned outside the catheter shaft to slide proximally and move through the aperture and along the respective mechanical abrasion element lumen in the catheter shaft.
8 . The device of claim 1 , wherein the catheter shaft further comprises a pair of mechanical abrasion element lumens, each one of the lumens is sized to allow a mechanical abrasion element within the lumen to translate axially relative to the catheter shaft.
9 . The device of claim 1 , further comprising a collar fixing a distal most end of each one of the pair of the mechanical abrasion elements to the catheter shaft at a location distal to the balloon.
10 . The device of claim 1 wherein the tissue contacting surface of each one of the pair of mechanical abrasion elements includes one or more features to enhance tissue contact or engagement when the balloon is in a partially inflated condition.
11 . The device of claim 1 , wherein an external surface of the balloon has a rough surface finish.
12 . The device of claim 1 wherein inflation and deflation of the balloon causes the first section of each of the pair of the mechanical abrasion elements to translate axially relative to the catheter shaft.
13 . The device of claim 1 , the hub further comprising a connector on the inflation port and a connector on the fluid port, wherein each connector 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 catheter shaft proximal end;
a compliant balloon on the catheter shaft adjacent to the distal end, the compliant balloon sized for expanding the vein during treatment;
an atraumatic tip on catheter shaft distal end;
a single elongated rectangular aspiration and injection port in the catheter shaft positioned 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; and
a fluid lumen within the catheter shaft only in fluid communication with the single elongated rectangular aspiration and injection port in the catheter shaft and a fluid port on the hub; and
two wires extending along the catheter shaft and over the compliant balloon, wherein in use during treatment within the vein at least a section of each of the two wires is configured to deflect radially outwardly alongside the compliant balloon into contact with a portion of the vein when the compliant balloon is inflated and to deflect radially inwardly alongside the compliant balloon when the compliant balloon is deflated.
15 . The device of claim 14 , wherein the two wires are positioned on opposite sides of the catheter shaft or a first wire of the two wires is positioned around the catheter shaft at a circumferential position of between 45-135° and a second wire of the two wires is positioned around the catheter shaft at a circumferential position between 225-315°.
16 . The device of claim 14 , wherein the two wires comprise stainless steel, nitinol or a biocompatible metal.
17 . The device of claim 14 , wherein the two wires comprise a length of about 70-180 mm and a diameter of about 0.1-0.6 mm.
18 . The device of claim 14 , wherein the two wires comprise a cross-sectional shape that is generally circular, ovular, or rectangular.
19 . The device of claim 14 , wherein the fluid lumen comprises a cross sectional area of about 0.2-0.32 mm and wherein the inflation lumen comprises a cross sectional area of about 0.2-0.32 mm.
20 . The device of claim 14 , wherein
a proximal end of the two wires is configured to translate axially along the catheter outer surface or axially along a lumen within the catheter sidewall and the distal end of the two wires is fixed to an outer surface of the catheter shaft distal to the balloon; or
a distal end of the two wires is configured to translate axially along the catheter outer surface or axially along a lumen within the catheter sidewall and the proximal end of the two wires is fixed to an outer surface of the catheter shaft proximal to the balloon.
21 . The device of claim 14 wherein the at least a section of the two wires configured to deflect radially outwardly alongside the balloon has a length of at least 20 mm.
22 . The device of claim 14 wherein a distal end of each of the two wires is coupled to the catheter shaft at a distance from 7 mm to 20 mm from a distal end of the balloon and a proximal end of each of the two wires is coupled to the catheter shaft at a distance from 12 mm to 25 mm from a proximal end of the balloon.
23 . A vein treatment device, comprising:
a catheter shaft having a proximal end and a distal end;
a hub coupled to the catheter shaft proximal end;
a compliant balloon on the catheter shaft adjacent to the distal end, the compliant balloon having a partially inflated diameter from 3 mm to 14 mm;
an atraumatic tip on catheter shaft distal end;
an opening in the atraumatic tip in communication with a guide wire lumen that extends from the opening to the hub;
an aspiration and injection port 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 aspiration and injection port and a fluid port on the hub;
a first mechanical abrasion element having a distal end, a tissue engagement portion and a proximal end;
a second mechanical abrasion element having a distal end, a tissue engagement portion and a proximal end;
a first mechanical abrasion element lumen within and extending along a sidewall of the catheter shaft and in communication with a first aperture formed in a sidewall of the catheter shaft;
a second mechanical abrasion element lumen within and extending along a sidewall of the catheter shaft and in communication with a second aperture formed in a sidewall of the catheter shaft; and
wherein inflating the compliant balloon to a pressure of less than one atmosphere transitions the compliant balloon from a deflated condition to a partially inflated condition to cause an increase in the radial spacing between the tissue engagement portion of the first mechanical abrasion element relative to the catheter shaft and the radial spacing between the tissue engagement portion of the second mechanical abrasion element relative to the catheter shaft.
24 . The device of claim 23 further wherein the transition of the compliant balloon from a deflated condition to a partially inflated condition causes translation along the catheter shaft of the distal end or the proximal end of the first mechanical abrasion element and translation along the catheter shaft of the distal end or the proximal end of the second mechanical abrasion element.
25 . The device of claim 24 wherein translation along the catheter shaft is within and along the first mechanical abrasion element lumen for the first mechanical abrasion element and within and along the second mechanical abrasion element lumen for the second mechanical abrasion element.
26 . The device of claim 23 wherein one of the proximal end or the distal end of the first mechanical abrasion element has a cross section that conforms to a cross section of the first mechanical abrasion element lumen and the other of the proximal end or the distal end of the first mechanical abrasion element has at least one surface shaped to correspond to an outer radius of the catheter shaft and wherein one of the proximal end or the distal end of the second mechanical abrasion element has a cross section that conforms to a cross section of the second mechanical abrasion element lumen and the other of the proximal end or the distal end of the second mechanical abrasion element has at least one surface shaped to correspond to an outer radius of the catheter shaft.
27 . The device of claim 23 , wherein the tissue engagement portion of the first mechanical abrasion element has an inner surface with a radius of curvature adapted to correspond to a radius of the compliant balloon in a partially inflated condition or a fully inflated condition and the tissue engagement portion of the second mechanical abrasion element has an inner surface with a radius of curvature adapted to correspond to a radius of the compliant balloon in a partially inflated condition or a fully inflated condition.
28 . The device of claim 23 the tissue engagement portion of the first mechanical abrasion element has an outer surface configured for controllable engagement with a the vein wall and the tissue engagement portion of the second mechanical abrasion element has an outer surface configured for controllable engagement with the vein wall.
29 . The device of claim 28 the outer surface of the tissue engagement portion of the first mechanical abrasion element and the outer surface of the tissue engagement portion of the second mechanical abrasion element further comprising one or more features to enhance tissue contact or engagement when the compliant balloon is in a partially inflated condition.
30 . The device of claim 23 wherein an angle between the first mechanical abrasion element lumen within and extending along a sidewall of the catheter shaft and the first aperture formed in a sidewall of the catheter shaft or an angle between the second mechanical abrasion element lumen within and extending along a sidewall of the catheter shaft and the second aperture formed in a sidewall of the catheter shaft is 90 degrees or between 10 degrees and 50 degrees.