Methods, devices and systems for filling body cavities
Inventors
Zugates, Gregory T. • Lomakin, Joseph • Mortensen, Jennifer • Groom, II, Jeffrey • Marini, John • Webber, Stephanie
Assignees
Publication Number
US-11207074-B2
Publication Date
2021-12-28
Expiration Date
2035-09-22
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Abstract
In various aspects, present disclosure is directed to methods, devices and systems whereby one or more low viscosity fluids may be introduced into a catheter and whereby the one or more low viscosity fluids may be converted into a high viscosity fluid in the catheter, which high viscosity fluid may be delivered from an exit port of the catheter.
Core Innovation
The present disclosure describes methods, devices, and systems for introducing one or more low viscosity fluids into a catheter and converting them to a high viscosity fluid within the catheter, with the high viscosity fluid then delivered from an exit port of the catheter. The catheter system can operate with a single low viscosity fluid that undergoes an increase in viscosity when exposed to heat or light, or with two low viscosity fluids that are mixed together in the catheter to form the high viscosity fluid prior to exit.
This innovation addresses the clinical problem of safely and effectively filling or partially filling body cavities, vessels, or other internal spaces with materials, where prior methods risk unwanted material movement outside the intended treatment zone, potentially leading to complications such as reduced efficacy or increased morbidity. Specifically, material migration during the treatment of aneurysms and other vascular or tumorous conditions is a key concern addressed by this invention.
The disclosed systems enable the formation of a high viscosity material near the catheter's exit port, often within 5 cm, which facilitates the use of low profile (small diameter) catheters while still delivering materials that remain localized in the treatment area. Additionally, the high viscosity fluid can be formulated to further cure into a solid material after placement, aiding retention and conforming to the body cavity's shape. Various chemical formulations and activation mechanisms are described to controllably achieve the desired viscosity and subsequently, if needed, curing.
Claims Coverage
The patent contains several independent claims that disclose distinct inventive features related to systems for converting low viscosity fluids into high viscosity fluids or solids within catheters for filling body cavities.
System with catheter and controlled in situ viscosity transition via energy activation
A system comprising: - A catheter with a first lumen having a proximal end to receive a low viscosity fluid and a distal end with an exit port proximal to the distal end. - A source of thermal energy, radiofrequency energy, or light configured to expose the low viscosity fluid to the respective energy and convert it to a high viscosity fluid. - The system is specifically configured to form the high viscosity fluid only at the distal end of the catheter within 5 cm of the exit port.
System for photoinitiated viscosity increase with specific chemical composition
A system comprising: - A catheter with a first lumen and an exit port proximal to the distal end. - A source of light to expose a low viscosity fluid to light, converting it to a high viscosity fluid within 5 cm of the exit port. - The low viscosity fluid specifically comprises an acrylate and a diacrylate and is converted by exposure to UV light.
System for light-activated viscosity increase with photoinitiator
A system comprising: - A catheter with a first lumen and exit port proximal to the distal end. - A source of light configured to expose a light-activated formulation to light and convert it to a high viscosity fluid within 5 cm of the exit port. - The low viscosity fluid includes an acrylate, a diacrylate, and a photoinitiator.
System for heat-activated viscosity increase with silicone triisocyanate and specific amine catalyst
A system comprising: - A catheter with a first lumen and exit port proximal to the distal end. - A source of thermal energy, radiofrequency energy, or light to convert the low viscosity fluid to high viscosity within 5 cm of the exit port. - The low viscosity fluid consists of a heat-activated formulation including a multi-functional isocyanate (specifically, a silicone triisocyanate) mixed with an amine catalyst (specifically, 1,8-diazabicycloundec-7-ene).
Dual lumen catheter system with in situ mixing and powered mixing element
A system comprising: - A catheter with proximal and distal ends, including first and second lumens, at least one terminating in an exit port proximal to the distal end. - A mixing element located at the distal end, fluidly communicating with the lumens. - A power source delivering mixing energy (mechanical, acoustic, electromechanical, or radiofrequency). - The catheter receives first and second low viscosity fluids at respective proximal ends and mixes them between the exit port and the mixer. - The mixed fluids are configured to form a high viscosity fluid.
The independent claims collectively cover systems and catheter designs for precise conversion and delivery of fluids with controllable viscosity and curing profiles, using specific energy sources or mixing mechanisms, enabling effective filling or treating of body cavities.
Stated Advantages
Enables the use of low profile catheters for delivery of high viscosity materials to a target body cavity.
Allows for repeated stopping and starting of flow through such catheters.
Facilitates delivery of high viscosity materials that are retained within a target body cavity.
Permits delivery of materials that conform to, take the shape of, and may be compliant with a target body cavity.
Documented Applications
Controlling hemorrhage, preventing aneurysm growth or risk of rupture, treating tumors, and managing respiratory disorders where filling or partially filling a body space is required.
Treatment of aneurysms, including those in the abdominal aorta and the brain.
Filling arteriovenous malformations.
Blockage of feeder arteries for tumors in the treatment of malignant and benign tumors such as kidney lesions, liver lesions (typically hepatocellular carcinoma), and uterine fibroids.
Vascular embolization procedures, particularly those where local control is important.
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