Vascular medical devices with sealing elements and procedures for the treatment of isolated vessel sections
Devices for the isolation of a selected portion of a vessel are described. In some embodiments, the device has an introducer sheath and a sealing catheter that are movable relative to each other to create an isolated volume with adjustable size and location. The methods for the treatment of vascular aneurysms using the devices are described. The treatment is achieved through the delivery of an effective amount of stabilization agent to an isolated volume that encompass the aneurysm. The device optionally has an aspiration device to improve the effectives of the treatment.
1. A device for treating an isolated portion of a blood vessel, the device comprising:
a sealing catheter comprising a proximal end, a distal end, a first sealing element, a fluid exchange lumen extending from the proximal end to at or near the distal end, and at least one fluid exchange opening in fluid communication with the fluid exchange lumen, wherein the fluid exchange lumen is in fluid communication with a port at or near the proximal end of the sealing catheter, wherein the first sealing element is attached distal to the fluid exchange opening at or near the distal end of the sealing catheter, and wherein the first sealing element comprises a first extendable element that can be transformed between a lower profile configuration and an extended configuration;
an introducer sheath comprising a proximal end, a distal end, a fitting, and a second sealing element attached at or near the distal end of the introducer sheath, wherein the second sealing element comprises a second extendable element that can be transformed between a lower profile configuration and an extended configuration, wherein the sealing catheter extends through the fitting of the introducer sheath such that the fitting allows the relative movement of the sealing catheter and the introducer sheath; and
a delivery element operably connected to the port of the sealing catheter wherein the delivery element comprises a stabilizing liquid that reacts with vessel tissue to stabilize the tissue and is in fluid communication with the fluid exchange opening through the lumen and the port of the sealing catheter, the stabilizing liquid comprising a phenolic compound having a hydrophobic core and one or more phenol groups extending from the hydrophobic core.
2. The device of claim 1 wherein the first sealing element comprises a first balloon having an interior that is inflated in the extended configuration and un-inflated in the lower profile configuration and wherein the sealing catheter comprises a first balloon lumen in fluid communication with the first balloon interior and a proximal inflation port.
3. The device of claim 1 wherein the stabilizing liquid comprises pentagalloylglucose.
4. The device of claim 1 wherein the second extendable element comprises a second balloon having an interior that is inflated in the extended configuration and un-inflated in the lower profile configuration and wherein the introducer sheath comprises a second balloon lumen in fluid communication with the second balloon interior and a proximal inflation port.
5. The device of claim 1 wherein the introducer sheath comprises a main lumen that extends between the fitting and a distal opening of the introducer sheath wherein the sealing catheter extends through the main lumen.
6. The device of claim 5 wherein a proximal aspiration port is in fluid communication with the main lumen and wherein the proximal aspiration port is operably connected to an aspiration apparatus.
7. A device for treating an isolated portion of a blood vessel, the device comprising:
a sealing catheter comprising a proximal end, a distal end, a first sealing element, a fluid exchange lumen extending from the proximal end to at or near the distal end, and at least one fluid exchange opening in fluid communication with the fluid exchange lumen, wherein the fluid exchange lumen is in fluid communication with a port at or near the proximal end of the sealing catheter, wherein the first sealing element is attached distal to the fluid exchange opening at or near the distal end of the sealing catheter, and wherein the first sealing element comprises a first extendable element that can be transformed between a lower profile configuration and an extended configuration; and
an introducer sheath comprising a proximal end, a distal end, a fitting, and a second sealing element attached at or near the distal end of the introducer sheath, wherein the second sealing element comprises a second extendable element that can be transformed between a lower profile configuration and an extended configuration, wherein the sealing catheter extends through the fitting of the introducer sheath such that the fitting allows relative movement of the sealing catheter and the introducer sheath,
wherein the first sealing element comprises a first balloon having an interior that is inflated in the extended configuration and un-inflated in the lower profile configuration, wherein the sealing catheter comprises a first balloon lumen in fluid communication with the balloon interior and a proximal inflation port and wherein the inflated first balloon has a generally cylindrical shape comprising distal and proximal ends that are concave or cupped in shape.
8. The device of claim 7 wherein the first balloon comprises a compliant polymeric material.