Methods for delivery of therapeutic materials to treat pancreatic cancer

Inventors

Agah, RamtinQURESHI, Imtiaz L.Najmabadi, KamranBAGAI, Shaun R.

Assignees

RenovoRx Inc

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Publication Number

US-10512761-B2

Patent

Publication Date

2019-12-24

Expiration Date


Abstract

Disclosed is a localized method for treatment of cancer including the steps of providing a drug delivery catheter; navigating the catheter to the bile duct; and delivering a therapeutic agent into the bile duct. According to one aspect of the method, the drug delivery catheter is a multi-occlusion balloon catheter. The multi-occlusion balloon catheter may include at least two balloons. The multi-occlusion balloon catheter may optionally include a pressure transducer between the balloons to optimize delivery technique.

Core Innovation

The invention provides a kit for localized pancreatic cancer therapy that includes a chemotherapeutic agent and a catheter device that can deliver the chemotherapeutic agent into a segment of a vessel. The catheter device includes an inner catheter defining an inner catheter lumen configured to receive a guidewire, and a first occlusion element coupled to the inner catheter at a first axial location along the catheter device. The catheter device also includes an outer catheter with a side wall defining an infusion aperture, where the outer catheter defines a first lumen in fluid communication with the infusion aperture and a second lumen in which a portion of the inner catheter is slidably disposed.

A second occlusion element is coupled to the outer catheter at a second axial location spaced apart from the first axial location such that the infusion aperture is between the first occlusion element and the second occlusion element. The first occlusion element and the second occlusion element are configured to isolate a segment of a vessel, thereby defining a delivery region around the infusion aperture. An adapter coupled to the outer catheter includes a first port and a second port, where the first port is in fluid communication with the first lumen through which the chemotherapeutic agent can be conveyed to the isolated segment, while the second port is in fluid communication with the second lumen.

In further embodiments, the system includes configurations for monitoring and control of delivery using pressure monitoring and an optional pressure sensor coupled to the catheter device to monitor infusion pressure within the segment isolated by the occlusion elements. The catheter device also incorporates sealing features on the outer catheter to prevent a chemotherapeutic agent from entering the second lumen of the outer catheter. The device further supports occlusion elements and catheter structures that enable isolated segment delivery, including configurations in which the first occlusion element and the second occlusion element are spaced apart by a distance and may transition between collapsed and expanded configurations.

Claims Coverage

Two independent claims are present. The claims define a chemotherapeutic agent kit with a multi-occlusion catheter system and adapter-based fluid routing, with inventive features centered on vessel isolation around an infusion aperture and pressure monitoring compatibility.

Multi-occlusion catheter with infusion aperture between occlusion elements

A catheter device including an inner catheter with an inner catheter lumen configured to receive a guidewire; a first occlusion element coupled to the inner catheter at a first axial location; an outer catheter with a side wall defining an infusion aperture, a first lumen in fluid communication with the infusion aperture, and a second lumen in which a portion of the inner catheter is slidably disposed; and a second occlusion element coupled to the outer catheter at a second axial location spaced apart from the first axial location such that the infusion aperture is between the first occlusion element and the second occlusion element, the first occlusion element and the second occlusion element configured to isolate a segment of a vessel.

Adapter routing chemotherapeutic agent to isolated segment while maintaining second-lumen communication

An adapter coupled to the outer catheter including a first port and a second port, the first port in fluid communication with the first lumen through which the chemotherapeutic agent can be conveyed to the segment of the vessel isolated by the first occlusion element and the second occlusion element, and the second port in fluid communication with the second lumen.

Pressure-sensor compatible isolated-vessel delivery configuration

A catheter device where an inner catheter includes a first occlusion element and defines an inner catheter lumen and an opening at a distal end in fluid communication with the inner catheter lumen and an environment exterior to the inner catheter and the first occlusion element; an outer catheter includes a second occlusion element and a side wall defining an infusion aperture, the outer catheter defines a first lumen in fluid communication with the infusion aperture and a second lumen within which a first portion of the inner catheter is slidably received, the second occlusion element spaced apart from the first occlusion element by a distance such that the first occlusion element and the second occlusion element isolate a segment of a vessel; and an adapter coupled to the outer catheter including a first port and a second port where the first port is in fluid communication with the first lumen through which the chemotherapeutic agent can be conveyed to the isolated segment, and the second port is configured to receive a second portion of the inner catheter.

Infusion pressure monitoring within isolated segment

The catheter device configured to be coupled to a pressure sensor to monitor an infusion pressure within the segment of the vessel isolated by the first occlusion element and the second occlusion element.

Across the independent claims, the kit centers on a catheter device that isolates a vessel segment using first and second occlusion elements positioned to flank an infusion aperture, and an adapter that routes a chemotherapeutic agent to the isolated segment while maintaining defined fluid communication with a second lumen. One independent claim further emphasizes a pressure-sensor compatible configuration to monitor infusion pressure within the isolated vessel segment.

Stated Advantages

Not explicitly described in patent.

Documented Applications

Not explicitly described in patent.

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