In situ forming hemostatic foam implants
Inventors
Sharma, Upma • Gitlin, Irina • Zugates, Gregory T. • Rago, Adam • Zamiri, Parisa • Busold, Rany • Caulkins, Robert J. • Freyman, Toby • Pham, Quynh • You, Changcheng • Carbeck, Jeffrey
Assignees
Publication Number
US-10307515-B2
Publication Date
2019-06-04
Expiration Date
2030-08-24
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Abstract
Systems and methods related to polymer foams are generally described. Some embodiments relate to compositions and methods for the preparation of polymer foams, and methods for using the polymer foams. The polymer foams can be applied to a body cavity and placed in contact with, for example, tissue, injured tissue, internal organs, etc. In some embodiments, the polymer foams can be formed within a body cavity (i.e., in situ foam formation). In addition, the foamed polymers may be capable of exerting a pressure on an internal surface of a body cavity and preventing or limiting movement of a bodily fluid (e.g., blood, etc.).
Core Innovation
The invention provides systems and methods for forming polymer foams in situ within a body cavity. These foams are created by introducing a flowable polymer formulation, such as a mixture of a polyol and a multifunctional isocyanate, into a body cavity, then allowing the formulation to undergo foaming and cross-linking, resulting in the formation of an elastomeric polyurethane foam. This foam is capable of exerting pressure against internal surfaces and can be tailored to specific mechanical and physicochemical properties by modifying formulation components and reaction conditions.
The core problem addressed by the invention is the early stabilization of body fluid loss, especially for internal wounds where traditional treatments are difficult to implement. Previous wound treatment materials using polymers have faced problems such as tissue irritation, lack of biodegradability, inadequate mechanical properties, and difficulty of delivery to the wound site, particularly within body cavities. The present invention aims to overcome these limitations by providing biocompatible and, in some cases, biodegradable foams with adjustable properties suitable for application inside the body.
Key aspects of the invention include the ability to deploy the polymer foams into closed body cavities without requiring precise knowledge of the injury location, as the expanding foam creates conformal contact throughout the cavity. The formulations can be tailored for viscosity, expansion ratio, hydrophilicity, and other attributes to optimize performance in diverse clinical scenarios. Furthermore, the system includes devices for delivering the separated polymer components and mixing them at the point of application, enabling controlled in situ formation of the foam implant.
Claims Coverage
The independent claim defines a system for forming a medical implant with three main inventive features.
Separated polyol and multifunctional isocyanate compositions
The system includes a first composition comprising a polyol and a second composition comprising a multifunctional isocyanate. The first and second compositions are physically separated before use, which facilitates controlled mixing and prevents premature reaction.
Mechanism for in situ formation of elastomeric polyurethane foam
A mechanism is provided that brings the separated compositions into contact, resulting in the formation of an elastomeric polyurethane foam. This foam is designed to undergo greater than 12 times expansion when introduced into a body cavity.
Delivery device for flow into a body cavity
The system includes a device that is insertable into a patient’s body and configured to permit flow of the mixture of the first and second compositions into a body cavity, enabling in situ formation of the foam implant to limit bodily fluid movement.
Overall, the inventive features cover the combination of separated reactive components, means for controlled mixing and expansion to form a medical polyurethane foam implant, and a delivery system for direct application into a body cavity.
Stated Advantages
The polymers can be deployed into a closed body cavity without requiring specific knowledge of injury sites, enabling conformal contact with actively bleeding injuries throughout the cavity.
The polymer foams can limit or prevent movement of bodily fluids and reduce bleeding compared to untreated conditions.
Formulations can be tailored for viscosity, expansion, density, softness, and hydrophilicity or hydrophobicity to optimize performance for different medical situations.
Foams of the invention are biocompatible, and can be made biodegradable for safe use within the body.
Foams provide mechanical support to internal tissues without interfering with physiological functions such as respiration or cardiac output.
Delivery systems enable easy and efficient transport of the components and formation of the foam in situ, including in tortuous or difficult-to-access spaces.
Documented Applications
Providing hemostasis in internal body cavities, such as abdominal, pelvic, or cardiothoracic cavities, by preventing or limiting bleeding from organs and tissues.
Filling body cavities created by tissue loss, for example due to trauma or surgery, to stabilize and support internal tissues or organs.
Preventing tissue adhesions, such as fibrotic scars, between internal tissues following injury or surgical intervention in regions including the abdomen, pelvis, spine, cardiothoracic space, and joints.
Treating external wounds and burns by forming a protective foam or gel coating.
Interested in licensing this patent?