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-10980920-B2
Publication Date
2021-04-20
Expiration Date
2030-08-24
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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 relates to systems and methods for the preparation and use of polymer foams that are able to form in situ within a body cavity, such as the abdominal or pelvic regions. The polymer foams can be applied as a flowable or injectable fluid which, upon introduction into a body cavity, expands and solidifies to form an elastomeric foam that conforms to the internal cavity’s shape. The foamed polymers may exert pressure on internal surfaces and are designed to prevent or limit movement of bodily fluids, such as blood.
This technology addresses the challenge of stabilizing body fluid loss—particularly hemorrhage—in situations where rapid surgical intervention is not available and where traditional techniques like direct pressure are difficult or impossible due to the location or nature of the internal wounds. Previous polymer-based treatments suffered from disadvantages such as tissue irritation, inadequate biodegradability, and poor mechanical properties for internal applications, as well as difficulty in placement within the body cavity.
The core innovation involves delivering a polymer formulation that is flowable and able to be foamed and cross-linked within the body cavity, creating a conformal and potentially tissue-adhering foam that serves to compress wounds, seal tissue, and control hemorrhage. The materials and delivery systems allow for use without precise knowledge of injury locations, as the expanding foam can make conformal contact throughout the cavity, providing stabilization and support. The foam formulation can be tailored for desired mechanical and physical properties, including the kinetics of foam formation, viscosity, softness, and expansion, as well as targeted functionalities such as tissue adhesion or prevention of tissue adhesion.
Claims Coverage
There are two independent claims in the patent, each defining a key inventive feature relating to the treatment of hemorrhage using in situ forming foams or gels.
In situ formation of expanding foam or gel for hemostasis
A method involves depositing a fluid configured to form a foam or gel in situ within a body cavity at or near a hemorrhage site in a patient. The fluid expands upon deposition, thereby applying pressure to the walls of the body cavity to provide hemostasis. This approach enables the fluid to be delivered as a single phase or mixture that transitions to a solid expanded foam or gel after application, resulting in internal compression and hemostasis at the bleeding site.
Two-component system for in situ foam formation in pelvic hemorrhage
A method for treating a pelvic hemorrhage comprises mixing a first composition containing a multifunctional isocyanate with a second composition comprising a polyol with up to 50 wt % polyethylene oxide, up to 10 pphp of an amine catalyst, and up to 20 pphp of water. This mixture is deposited within the pelvic cavity, where it forms a foam in situ that achieves close apposition to the wound site and applies pressure to the hemorrhage, thereby limiting blood flow. The formulation is specifically designed for in situ reaction and expansion tailored to pelvic trauma.
The independent claims define both a broad method of in situ foam or gel formation for hemorrhage control and a more specific implementation using a dual-component system for in situ foam formation in pelvic hemorrhage. Both inventive features focus on applying controlled internal pressure through foam expansion for hemostasis.
Stated Advantages
The polymer foam can be deployed in a closed body cavity and forms conformal contact with actively bleeding injuries throughout the cavity without requiring specific knowledge of injury locations.
Formulations allow for delivery and permeation throughout tortuous body cavities and through pooled blood, achieving effective contact with the wound site.
Physical characteristics such as viscosity, softness, density, and expansion can be tailored for optimal performance and compatibility with tissue and bodily fluids.
Foams are biocompatible and, in some embodiments, biodegradable, allowing for eventual safe removal or absorption.
Internal compression is provided in situ which may be critical for treating incompressible hemorrhages or wounds that are unable to be directly visualized.
Foams can be formulated to minimize interference with bodily functions (e.g., respiration, cardiac output) due to their compressibility and mechanical properties.
Foams facilitate hemostasis by reducing blood flow, supporting clot stabilization, and creating mechanical barriers at sites of injury.
The technology also allows for removal of foam via standard surgical procedures or controlled degradation.
Documented Applications
Treatment of hemorrhage in body cavities, including abdominal and pelvic hemorrhage, particularly where wounds are incompressible or not easily visualized.
Formation of in situ foams or gels to achieve internal pressure and hemostasis at wound sites resulting from blunt trauma or surgical intervention.
Support and stabilization of bodily fluid loss from organs such as the liver or spleen.
Filling body cavities resulting from tissue loss, such as from open wounds or surgical incisions.
Prevention of tissue adhesions post-surgery or following tissue damage by placing a polymer foam between tissues.
Use in both enclosed body cavities and on external wounds, including treatment of burns.
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