METHODS AND DEVICES FOR TREATMENT OF THE OSTIUM
Methods and devices for treatment of the ostium are described herein. Examples of such devices include inflatable balloons which have one or more raised pores along a distal portion which act as conduits for providing saline flow from the balloon to facilitate visualization of the contacted tissue as well as providing for a conduction path for energy delivery. The balloon may be configured in various shapes to facilitate contact of the balloon in and against the ostium.
1 . A tissue treatment device configured to treat an ostium of a vessel, comprising:
an elongate catheter;
an expandable inner membrane attached along a distal end of the catheter and in fluid communication with a first opening along the catheter;
an expandable outer membrane attached along the distal end such that the inner membrane is enclosed by the outer membrane and is in fluid communication with a second opening along the catheter, wherein the outer membrane and inner membrane form an annular space therebetween which is in fluid communication with an environment external to the outer membrane through one or more openings defined along a distal portion of the outer membrane; and,
one or more electrodes in proximity to the one or more openings such that the electrodes are in communication with the environment.
2 . The device of claim 1 further comprising an imager positioned within or along the catheter for visualizing the ostium when contacted against the outer membrane.
3 . The device of claim 1 wherein the expandable inner membrane comprises an inflatable balloon.
4 . The device of claim 1 wherein the expandable outer membrane defines one or more raised ports.
5 . The device of claim 1 wherein the one or more electrodes are positioned along an exterior of the inner membrane.
6 . The device of claim 1 wherein the one or more electrodes are positioned about the one or more openings.
7 . The device of claim 1 further comprising a conductive fluid which is introduced through the second opening and through the annular space such that the fluid contacts the one or more electrodes.
8 . The device of claim 1 wherein the outer membrane defines one or more ridges which protrude from an external surface of the outer membrane such that the one or more openings are defined along the ridges.
9 . The device of claim 8 wherein the one or more ridges are defined longitudinally or circumferentially along the external surface relative to the device.
10 . The device of claim 1 wherein the one or more openings are clustered within one or more defined patches along the outer membrane.
11 . The device of claim 1 wherein the one or more openings are defined circumferentially about the outer membrane.
12 . The device of claim 1 further comprising one or more partitions within the inner membrane.
13 . The device of claim 1 further comprising a rotatable member within the inner membrane which is selectively positionable into proximity of the one or more openings.
14 . The device of claim 1 further comprising a flexible frame within or along the device such that the frame is movable between a low-profile configuration and a deployed configuration.
15 . The device of claim 1 further comprising an inflatable occlusion balloon attached to the catheter distal to the outer membrane.
16 . The device of claim 15 wherein a portion of the catheter is adjustable in length between the occlusion balloon and outer membrane.
17 . The device of claim 1 wherein the device defines one or more channels from a distal end of the device to a proximal end of the device.
18 . A method of treating an ostium of a vessel, comprising:
expanding an inner membrane and an outer membrane enclosing the inner membrane each attached along a distal end of the catheter within or against an ostium of a vessel;
introducing a conductive fluid into an annular space defined between the inner membrane and the outer membrane such that the fluid passes through one or more openings defined along the outer membrane and into an environment external thereto;
actuating one or more electrodes positioned in proximity to the one or more openings such that energy is delivered through the fluid and into the ostium external to the outer membrane; and,
visualizing the ostium through the outer membrane.
19 . The method of claim 18 wherein expanding an inner membrane comprises inflating the inner membrane via a transparent gas or fluid.
20 . The method of claim 18 wherein expanding an inner membrane comprises expanding a flexible frame within or along the inner membrane.
21 . The method of claim 18 wherein introducing a conductive fluid comprises introducing saline fluid into the annular space.
22 . The method of claim 18 wherein introducing a conductive fluid comprises passing the fluid through one or more openings which are raised relative to a surface of the outer membrane.
23 . The method of claim 18 wherein actuating one or more electrodes comprises actuating the one or more electrodes positioned along an exterior surface of the inner membrane and in proximity to the one or more openings.
24 . The method of claim 18 wherein actuating one or more electrodes comprises actuating the one or more electrodes positioned about each of the one or more openings.
25 . The method of claim 18 wherein visualizing the ostium comprises visualizing via an imager positioned along the catheter within the inner membrane.