Variable length catheter for drug delivery

Inventors

Solar, Ronald J. • Shaked, Yoav • Lieber, Glen

Assignees

ThermopeutiX Inc

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Publication Number

US-8721592-B2

Patent

Publication Date

2014-05-13

Expiration Date


Abstract

A system and method for localized delivery of a therapeutic or diagnostic agent within a vessel is provided. The system and method provide for adjustability of the length of the treatment area and for reducing of pressure within the treatment area. A catheter system includes an inner elongated element, an outer elongated element positioned coaxially with respect to the inner elongated element, and a blood-release element at a distal end of the inner elongated element. A proximal occlusion element is positioned at the distal end of the outer elongated element, proximal to an outlet port. A distal occlusion element is positioned at a distal end of the inner elongated element. The distal end of the inner elongated element is distal to and movable with respect to the outer elongated element distal end.

Core Innovation

The invention provides a catheter system that includes an outer elongated element and an inner elongated element arranged coaxially to define a delivery lumen between them. The outer elongated element includes an outer elongated element lumen extending from a proximal end to a distal end and an outlet port at the distal end, with a proximal occlusion element located at the outer elongated element distal end and proximal to the outlet port.

The inner elongated element includes an inner elongated element proximal end and an inner elongated element distal end, with a distal occlusion element located at the inner elongated element distal end. The inner elongated element is positioned within the outer elongated element lumen, and the distal end of the inner elongated element is distal to and movable with respect to the outer elongated element distal end. The inner elongated element further comprises a blood-release element at the inner elongated element distal end, enabling delivery of a substance to a vessel through the delivery lumen and through the outlet port.

A guidewire is positioned through the blood-release element such that the blood-release element remains at least partially open to blood-flow while the guidewire is positioned through it. In embodiments, blood-release is supported by a clearance between the blood-release element and the guidewire, and the treatment zone length varies according to relative positioning of the inner and outer elements. The disclosures also include hubs and ports for introducing a substance and inflation fluid, pressure monitoring, optional supply or auxiliary coaxial elements, and deployment with cyclic delivery and removal while maintaining blood flow, including retrograde access and various occlusion and anchoring configurations.

Claims Coverage

The document includes one independent claim (clm-00001) defining the overall coaxial catheter system architecture and the key blood-flow enabling feature when a guidewire is present. The independent claim is further narrowed by dependent claims specifying structural details of the occlusion/blood-release components and additional catheter interfaces and configurations.

Coaxially arranged inner and outer elongated elements with delivery lumen and outlet port

An outer elongated element with an outer elongated element lumen and an outlet port, and an inner elongated element positioned within the outer lumen in a coaxial arrangement that provides a delivery lumen for delivery of a substance to a vessel through the delivery lumen and through the outlet port.

Movable inner elongated element distal end relative to outer elongated element distal end for variable delivery zone

The inner elongated element distal end is distal to and movable with respect to the outer elongated element distal end such that a proximal and distal occlusion configuration defines a treatment zone whose length varies based on relative positioning.

Blood-release element at the inner elongated element distal end with guidewire positioned therethrough

The inner elongated element comprises a blood-release element at the inner elongated element distal end, and a guidewire is positioned through the blood-release element.

Blood-release element remains at least partially open to blood-flow when guidewire is positioned therethrough

When the guidewire is positioned through the blood-release element, the blood-release element remains at least partially open to blood-flow.

Across the independent claim and its dependents, the inventive coverage centers on a coaxial catheter that delivers a substance to a vessel via a delivery lumen and outlet port while a distal blood-release/blood-flow opening remains at least partially open during guidewire presence. Dependent refinements specify clearance and particular blood-release/occlusion structures, and further add catheter interfaces such as hubs for substance and inflation fluid.

Stated Advantages

Maintains blood-flow by keeping the blood-release element at least partially open to blood-flow when a guidewire is positioned through the blood-release element.

Enables localized delivery of a substance to a vessel through a delivery lumen and outlet port while using proximal and distal occlusion elements to define a treatment zone.

Allows the treatment zone length to vary based on relative movement of the inner and outer elongated elements.

Documented Applications

Localized therapeutic or diagnostic delivery to a vessel using a catheter system with a coaxial delivery lumen and outlet port.

Blood removal / pressure management during delivery by providing blood-flow through a blood-release element that remains at least partially open when a guidewire is present.

Use of hubs/ports enabling delivery and inflation fluid introduction related to occlusion elements during deployment with cyclic delivery and removal while maintaining blood flow, including retrograde access.

Perfusion or delivery of thermally treated blood using optional supply or auxiliary coaxial elements and an associated heating/cooling control unit [procedural detail omitted for safety].

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