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-11944724-B2
Publication Date
2024-04-02
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 provides systems and methods relating to polymer foams that can be formed in situ within a body cavity. These systems involve the introduction of flowable polymer formulations, composed of physically separated components, into body cavities, where the components are mixed and undergo a chemical reaction resulting in both cross-linking and foaming. The resulting elastomeric polymer foam expands in volume to fill the cavity, exerts pressure on internal surfaces, and serves to prevent or limit the movement of bodily fluids such as blood at wound sites.
This approach addresses issues with traditional polymer materials and hemostatic methods, which may cause tissue irritation, lack appropriate biodegradability, be either too stiff or too soft, or prove difficult to position properly within complex internal anatomy. The present invention overcomes these drawbacks by enabling in situ delivery and formation of polymer foams that are biocompatible and can be tailored for optimal viscosity, expansion, density, and mechanical properties to efficiently control bleeding and support tissues.
Specifically, the system comprises separate components that are mixed immediately prior to or during administration, such as a polyol and a polyisocyanate, forming a polymer that expands volumetrically by at least 12-fold upon reaction. This expansion can conformally contact and appose to wounds—even those that are not visualized—providing internal compression against tissue, and is achievable through various delivery devices, including static and dynamic mixing nozzles, or syringe plungers.
Claims Coverage
There is one independent claim defining the main inventive features of the system for in situ forming medical implants to limit movement of bodily fluids.
System comprising physically separated compositions and a mixing mechanism for in situ foam formation
The system includes: - A first composition and a second composition, which are physically separated until use. - A mechanism configured to mix these compositions to form a mixture having a first volume. - A device that is insertable into a patient's body and allows the mixture to flow into a body cavity. Upon mixing and delivery, the mixture forms a polymeric material that undergoes a volume expansion of at least 12× compared to its initial volume, enabling the formation of a medical implant designed to limit the movement of a bodily fluid.
The inventive feature centers on the system architecture that involves two physically separated components, an in situ mixing mechanism, and a device for the controlled formation and delivery of an expanding polymeric material within a body cavity for fluid movement limitation.
Stated Advantages
The polymer foam can be deployed within a closed body cavity without requiring specific knowledge of injury site location, providing conformal contact with actively bleeding injuries.
Polymer foams of the invention are biocompatible and, in some embodiments, biodegradable, making them suitable for internal use.
The systems allow for easy injection and delivery throughout a body cavity, even accessing difficult-to-reach or tortuous spaces due to the low viscosity and expanding nature of the formulations.
Foams expand rapidly and provide internal compression to control bleeding and stabilize tissues without interfering with physiological functions.
The viscosity, expansion, density, and mechanical properties of the foams can be tailored for specific therapeutic needs and anatomical locations.
Foams may provide support to organs or stabilize fluid loss in non-compressible hemorrhage situations where traditional methods are ineffective.
The foams can be visualized using contrast agents, aiding in clinical management and localization.
Documented Applications
Use of the polymer foam to control and limit bleeding within internal body cavities, especially in the treatment of wounds with non-compressible hemorrhage.
Providing support to and/or stabilizing bodily fluid loss from organs such as the liver and spleen, particularly in blunt trauma scenarios.
Filling body cavities created by loss of body tissue to limit the movement of bodily fluids such as blood, bile, digestive fluids, or interstitial fluid.
Formation of a barrier between tissues to prevent tissue adhesions, including use after surgical interventions to reduce fibrotic scars and associated complications.
Treatment of burns and other external wounds by application of polymer foam outside body cavities.
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