Occlusion catheter system and methods of use

Inventors

Agah, RamtinNajmabadi, KamranBAGAI, Shaun R.MALEK, Reza

Assignees

RenovoRx Inc

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Publication Number

US-10099040-B2

Patent

Publication Date

2018-10-16

Expiration Date


Abstract

In some embodiments, an apparatus includes a first catheter movably disposed within a first lumen of a second catheter. The first catheter has a first occlusion member disposed at a distal end portion and the second catheter has a second occlusion member disposed at a distal end portion. A third catheter has a third occlusion member disposed at a distal end portion and is moveably disposable within a second lumen of the second catheter. The second catheter has a side port in fluid communication with the second lumen and the third catheter can be extended out of the second lumen through the side port. The first occlusion member, second occlusion member and third occlusion member can collectively isolate a target region including a portion of a first body lumen (e.g., a main vessel) and a portion of a second body lumen (e.g., a branch of the main vessel).

Core Innovation

The disclosed invention relates to a multi-occlusion endovascular catheter system that collectively defines an isolated target region spanning a first body lumen and a second body lumen. The system includes a first catheter with a first occlusion member and a second catheter with a second occlusion member, where the first catheter is movably disposed within the first lumen of the second catheter. The first occlusion member and the second occlusion member collectively define a first portion of an isolated target region in a first body lumen.

The system further includes a third catheter having a third occlusion member, where the third catheter is movable through the second lumen of the second catheter and configured to be disposed through a side port into a second body lumen outside of the second lumen. The first occlusion member, the second occlusion member, and the third occlusion member collectively define the isolated target region including a first portion in the first body lumen and a second portion in the second body lumen. The isolated target region is fluidically isolated from other portions of the first body lumen and the second body lumen.

The system also includes an infusion lumen in communication with a side infusion port to communicate an active therapeutic material into the isolated target region. The side port has an outer diameter greater than an outer diameter of the side infusion port such that the third catheter can be disposed through the side port, thereby enabling coordinated occlusion and delivery into the fluidically isolated region.

Claims Coverage

The document provides three independent claim sets that cover apparatus and method implementations of a multi-catheter, multi-occlusion fluidically isolated treatment region with treatment delivery through side ports and optional side-branch occlusion using a third occlusion member. Across the independent claims, the coverage is organized around three inventive feature clusters: a movable catheter arrangement defining a fluidically isolated region across a main lumen and a side lumen, coordinated treatment delivery via an infusion lumen/side infusion port, and an occlusion-capable third catheter passing through a side port while sealing prevents unintended material entry.

Movable multi-catheter occlusion defining a fluidically isolated target region

A first catheter having a first occlusion member disposed at a distal end portion; a second catheter having a second occlusion member disposed at a distal end portion, the second catheter defining a first lumen, a second lumen, and a side port in fluid communication with the second lumen, the first catheter being movably disposed within the first lumen of the second catheter, the first occlusion member and the second occlusion member collectively configured to define a first portion of an isolated target region in a first body lumen; and a third catheter having a third occlusion member, the third catheter being movable through the second lumen of the second catheter and configured to be disposed through the side port into a second body lumen outside of the second lumen, the first occlusion member, the second occlusion member, and the third occlusion member collectively configured to define the isolated target region including the first portion and a second portion, the isolated target region being fluidically isolated from other portions of the first body lumen and the second body lumen.

Coordinated infusion of active therapeutic material into the isolated target region via a side infusion port

One of the first catheter or the second catheter defining an infusion lumen in communication with a side infusion port, the infusion lumen and the side infusion port configured to communicate an active therapeutic material into the isolated target region.

Side-port and infusion-port outer-diameter configuration enabling third catheter passage

The side port having an outer diameter greater than an outer diameter of the side infusion port such that the third catheter can be disposed through the side port.

Coaxial first and second catheters with adjustable distance occlusion to form an isolated arterial segment and fluidically isolated treatment region

A first catheter including a first occlusion member disposed at a distal end portion thereof; a second catheter including a second occlusion member disposed proximally of the first occlusion member at a distal end portion of the second catheter and at a spaced distance from the first occlusion member; at least one of the first catheter or the second catheter defining a first lumen in fluid communication with a first side port and a second lumen in fluid communication with a second side port; the first catheter and the second catheter being configured to be inserted into an artery with the first occlusion member and the second occlusion member each in a collapsed configuration, the first occlusion member and the second occlusion member each being movable to an expanded configuration within the artery to define a isolated segment of the artery; the second catheter defining a third lumen, the first catheter being movably disposed within the third lumen of the second catheter such that the first catheter and the second catheter are coaxial and a distance between the first occlusion member and the second occlusion member can be adjusted; the first lumen and the first side port configured to communicate an active treatment material to the isolated segment of the artery; and the second lumen and the second side port configured to receive the third catheter such that the third occlusion member can be disposed through the second side port and into a side branch in fluid communication with the artery and located between the first occlusion member and the second occlusion member, the third occlusion member configured to occlude the side branch such that the first occlusion member, the second occlusion member, and the third occlusion member collectively define a fluidically isolated segment including the isolated segment of the artery and a portion of the side branch proximal to the third occlusion member.

Sealing element covering a side port to permit third catheter exit while preventing outside material entry

A sealing element covering the second side port, the sealing element configured to permit the third catheter to exit the second side port, the sealing element configured to prevent material from entering the second side port from outside of the second lumen when the third catheter is not disposed in the second side port.

Method of isolating a main artery segment and an occluded side branch treatment region with active treatment material introduction

Inserting into an artery a first catheter having a first occlusion member disposed at a distal end portion thereof and a second catheter having a second occlusion member disposed proximally of the first occlusion member and at a spaced distance from the first occlusion member, the second catheter defining (i) a first side port and a first lumen in fluid communication with the first side port and (ii) a second side port and a second lumen in fluid communication with the second side port, the first side port disposed distal to and radially offset from the second side port, the first occlusion member and the second occlusion member each being in a collapsed configuration when the first catheter and the second catheter are inserted into the artery, the second catheter defining a third lumen, the first catheter being movably disposed within the third lumen of the second catheter such that the first catheter and the second catheter are coaxial and a distance between the first occlusion member and the second occlusion member can be adjusted; moving each of the first occlusion member and the second occlusion member to an expanded configuration within the artery to define an isolated segment of the artery; inserting through the second lumen and the second side port a treatment device having a third occlusion member that can be disposed through the second side port and into a side branch in fluid communication with the artery; occluding the side branch with the third occlusion member such that the first occlusion member, the second occlusion member, and the third occlusion member collectively define a fluidically isolated treatment region including the isolated segment of the artery and a portion of the side branch between the artery and the third occlusion member; and introducing through the first lumen and the first side port an active treatment material to the fluidically isolated treatment region.

Across the independent claims, the inventive concept is implemented by a multi-catheter system (including an optional third catheter) whose multiple occlusion members cooperate to fluidically isolate a treatment region spanning a main vessel segment and a side branch, while an active treatment material is introduced through a lumen/side port into the isolated region and a sealing/port diameter relationship enables third catheter passage and controlled side-port behavior.

Stated Advantages

Fluidically isolate the isolated target region from other portions of the first body lumen and the second body lumen.

Communicate an active therapeutic material or active treatment material into the fluidically isolated target region or fluidically isolated treatment region.

Enable the third catheter to be disposed through the side port via an outer diameter configuration relative to the side infusion port.

Prevent material from entering the side port from outside of the second lumen when the third catheter is not disposed in the side port.

Documented Applications

Pancreatic artery targeting, including isolating an area spanning a main vessel and a side branch within pancreatic-related anatomy (e.g., splenic artery, celiac artery, dorsal pancreatic artery, pancreatic magnum artery).

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