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-11246964-B2
Publication Date
2022-02-15
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 for forming polymer foams in situ within a body cavity to control the movement of bodily fluids, such as blood. The core innovation lies in introducing a flowable polymer formulation—comprised of physically separated components—into a body cavity, where the components are mixed, resulting in cross-linking and foaming to form an elastomeric, biocompatible, and optionally biodegradable polymeric foam or gel. This foam is capable of expanding within the cavity, conformally contacting tissues and wound sites, and providing hemostasis by limiting the movement or flow of bodily fluids even when the wound site is not directly visualized.
The problem addressed by the invention is the difficulty in treating internal wounds or body cavities when traditional means—such as direct manual pressure—are impossible to apply, particularly in situations where surgical intervention may be delayed or unavailable. Existing wound treatment polymers are hindered by skin and tissue irritation, insufficient biodegradability, inadequate mechanical properties, poor injectability, and lack of conformability to complex internal anatomical spaces.
The system achieves deployment by providing physically separated polymer compositions (such as poly(glycol sebacate) or polyurethane precursors) that are brought into contact by a mechanism (such as a syringe plunger or mixing nozzle) and then introduced through an introducer into the body. There, the compositions mix, crosslink, and foam in situ, creating a gel or foam that can exert pressure, block or reduce fluid movement, and conformally seal to tissues. The foam's properties—including viscosity, expansion ratio, hydrophilicity/hydrophobicity, and curing time—are specifically engineered to optimize hemostasis, prevent tissue adhesions, and ensure removal when required.
Claims Coverage
There is one independent claim that defines the core inventive features of the system for forming medical implants to limit bodily fluid movement.
System with physically separated compositions and in situ mixing mechanism
A system comprising a first composition and a second composition, physically separated until use, and a mechanism (selected from a syringe plunger, a static mixing nozzle, a dynamic mixing nozzle, and an impeller) that brings the two compositions together to form a polymeric material. The mechanism enables mixing of the compositions and subsequent formation of the polymeric material. The system includes an introducer configured for insertion into a patient's body, permitting the flow of the mixed compositions into a body cavity. Upon introduction, the mixture crosslinks and forms a gel. The resulting gel limits the movement of a bodily fluid within the body cavity.
The inventive features claim a system that enables in situ mixing and formation of a crosslinked polymeric gel or foam within a body cavity, specifically to limit bodily fluid movement, utilizing physically separated components and defined mixing and delivery mechanisms.
Stated Advantages
The polymers can be deployed into a closed body cavity without requiring specific knowledge of injury sites, while still achieving conformal contact with injuries throughout the cavity.
Delivery of polymer directly to and permeation throughout a body cavity is enabled, allowing for rapid formation of an expanding elastomeric foam that fills the cavity.
Mechanical and chemical properties (such as viscosity and wetting) of the polymers are tunable, facilitating injection, expansion, and conformal sealing.
Polymer foams can be designed to be biocompatible and/or biodegradable, supporting internal use and safe removal.
Formulations can be tailored to prevent tissue adhesions by forming coatings or barriers between tissues after injury or surgery.
Foams of the invention are soft and compressible, minimizing interference with physiological functions such as respiration or venous return.
Expansion and in situ formation enable the foam to reach and seal tortuous or inaccessible sites of injury within body cavities.
Formulations can facilitate imaging of the body cavity by interacting with contrast agents.
Documented Applications
Treatment of incompressible hemorrhage in body cavities where injuries may be unknown or unvisualized, such as abdominal, pelvic, and cardiothoracic cavities.
Providing support and stabilizing bodily fluid loss from damaged organs, including the liver and spleen, due to trauma.
Filling a body cavity created by loss of body tissue, including in open wounds or surgical incisions.
Prevention of tissue adhesions by placing foam or gel between tissues after injury or surgery in regions such as the abdomen, pelvis, spine, cardiothoracic space, and joints.
Sealing of wound sites to limit fluid flow, block digestive fluid movement, or stabilize blood clots within internal cavities.
Removing foam after use through surgical intervention or degradation by external stimuli (e.g., UV light, heat, chemical agents).
Use for external wounds, including the treatment of burns.
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