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-9999427-B2
Publication Date
2018-06-19
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 filling body cavities by introducing one or more low viscosity fluids into a catheter, where these fluids are converted within the catheter into a high viscosity fluid that is then delivered from the catheter's exit port. The system can operate by either subjecting a single low viscosity fluid to activation conditions, such as exposure to light or heat, or by mixing two low viscosity fluids, such as a multifunctional isocyanate and a nucleophilic species, to trigger rapid polymerization or curing reactions near the catheter tip.
A primary problem addressed by the invention lies in the challenge of delivering high viscosity or solidifying materials into targeted spaces within the body, such as blood vessels or cavities, particularly when using minimally invasive catheters with small diameters. High viscosity materials are difficult to push through small catheters due to increased pressure requirements, and unwanted movement of such materials outside the treatment zone can cause complications. The disclosed solution utilizes low viscosity fluids for easy delivery and then rapidly increases viscosity or induces curing only near the catheter exit, improving localization and retention of the treatment material.
The system includes catheters with one or more lumens that can accommodate the introduction and mixing of separate fluid components. Mixing or activation is achieved within a specified short segment (such as within 5 cm of the exit port), and the resulting high viscosity fluid can further cure into a solid after deployment, conforming to the shape of the target cavity or vascular site. Various combinations of chemical reagents, including polyisocyanates, diamines, diglycidyl ethers, divinyl sulfone, or hydride siloxanes, may be used depending on the specific formulation required for a given clinical procedure.
Claims Coverage
There are three independent claims in the patent, each providing a distinct inventive feature related to delivering high viscosity fluids from low viscosity precursors using catheters.
System for mixing low viscosity fluids in a catheter to form and deliver a high viscosity fluid
A system comprising: - A catheter with proximal and distal ends, having first and second lumens, at least one of which terminates in an exit port proximal to the distal end. - A mixing element located at the distal catheter portion proximal to the exit port and in fluid communication with both lumens. - First and second low viscosity fluids supplied to the respective lumens. - The catheter is configured to receive the fluids at the proximal ends, mix them between the exit port and the mixing element, and expel a high viscosity fluid (100,000 to 1,000,000 cP as measured by a parallel plate rheometer at a shear rate between 1 and 10 s⁻¹).
Method for treating a patient by in-catheter mixing of low viscosity fluids to deliver high viscosity fluid
A method comprising the steps of: 1. Inserting into a patient a catheter with first and second lumens and a mixing element located at the distal end proximal to the exit port. 2. Flowing first and second low viscosity fluids through the respective lumens and over the mixing element. 3. Mixing the fluids between the exit port and the mixing element, thereby forming and expelling a high viscosity fluid (100,000 to 1,000,000 cP as measured by a parallel plate rheometer at a shear rate between 1 and 10 s⁻¹) into the body of the patient.
Method for treating a patient with a system using polyisocyanate and water plus multifunctional alcohol to form high viscosity fluid
A method comprising: - Inserting a catheter (having first and second lumens, and a mixing element at the distal end proximal to the exit port) into the patient's body. - Flowing a first low viscosity fluid containing a polyisocyanate through the first lumen and a second low viscosity fluid containing water and a multifunctional alcohol through the second lumen, with mixing over the mixing element. - Forming and expelling a high viscosity fluid (100,000 to 1,000,000 cP as measured by a parallel plate rheometer at a shear rate between 1 and 10 s⁻¹) into the patient's body.
The inventive features collectively address systems and methods for the conversion and delivery of high viscosity fluids formed from low viscosity fluids via in-catheter mixing or activation, as well as specific material combinations used in the formation process.
Stated Advantages
Enables the use of low profile catheters for the delivery of high viscosity materials to a target body cavity.
Provides the ability to repeatedly stop and start the flow of high viscosity materials through such catheters.
Allows delivery of high viscosity materials that are retained within a target body cavity.
Facilitates delivery of materials that conform to or take the shape of, and may be compliant with, a target body cavity.
Documented Applications
Filling aneurysms that contain blood flow from inlet/outlet blood vessels, such as abdominal aortic aneurysms.
Vascular embolization procedures, particularly those where local control is important.
Filling arteriovenous malformations.
Blockage of feeder arteries for tumors, including treatment of malignant and benign tumors such as kidney lesions, liver lesions (typically hepatocellular carcinoma), and uterine fibroids.
Controlling hemorrhage, preventing aneurysm growth or risk of rupture, and treating tumors.
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