In situ forming hemostatic foam implants
Inventors
Sharma, Upma • Gitlin, Irina • Zugates, Gregory T. • Rago, Adam • Zamiri, Parisa • Busold, Rany • Freyman, Toby • Caulkins, Robert J. • Pham, Quynh P. • You, Changchen • Carbeck, Jeffrey D.
Assignees
Publication Number
US-9700656-B2
Publication Date
2017-07-11
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 for the control of bodily fluids such as blood. The core approach involves introducing a flowable polymer formulation into a body cavity, where it then undergoes a foaming and cross-linking reaction to form an elastomeric polymer foam directly at the site. This foam is capable of exerting pressure on tissue and internal surfaces, thereby preventing or limiting the movement of bodily fluids within the body cavity relative to the absence of the foam.
Problems with traditional wound treatment methods include the difficulty of stabilizing internal wounds when immediate surgical access is unavailable, as well as drawbacks in existing polymers such as tissue irritation, inadequate biodegradability, mechanical unsuitability, and challenges in precisely placing materials within body cavities. The present invention addresses these problems by formulating and delivering biocompatible, optionally biodegradable, and mechanically optimized polymers that can flow into and expand within complex or poorly visualized body cavities, forming conformal contact with injured tissues.
The invention describes multiple chemistries and formulation strategies for achieving in situ foam formation, including the use of polyols with isocyanates or condensation polymers of polyols and polyacids. The expansion and solidification of the foam are tailored to ensure optimal coverage, suitable pressure application, and support of internal tissues, with additional functionalities such as controlled degradation, drug delivery capabilities, and targeted tissue adhesion or non-adhesion.
Claims Coverage
There are two independent claims in this patent, each describing a method of forming a polymer foam within a body cavity to control the flow of bodily fluid with specified inventive features.
Formation of a crosslinked, gas-foamed polymer within a body cavity
A polymer formulation is created by combining a first component comprising a first polymer and a second component comprising a second polymer. The formulation is introduced into a body cavity, where it reacts to generate a gas, causing the formulation to foam. At least a portion of the first and second polymers crosslink in situ, resulting in a polymer foam. The process ensures a volume expansion of the polymer formulation greater than 12× upon foaming.
Method utilizing a polyol, water, and multifunctional isocyanate to form foamed polymer in situ
A method in which a first component containing a polyol and water is combined with a second component containing a multifunctional isocyanate to form a polymer formulation. Upon introduction into the body cavity, the water and multifunctional isocyanate react to generate carbon dioxide gas, thereby foaming the formulation. The polyol crosslinks in the presence of the multifunctional isocyanate, forming the polymer foam in situ. The polymer formulation undergoes a volume expansion greater than 12× upon foaming.
The inventive features focus on in situ generation of an expanding crosslinked polymer foam within a body cavity, employing either general crosslinking polymers or specific polyol-isocyanate chemistries, with the critical attribute of significant volume expansion and foaming to control bodily fluid movement.
Stated Advantages
The polymers can be deployed into a closed body cavity without requiring specific knowledge of the injury site while creating conformal contact with bleeding injuries located throughout the cavity.
The formulations enable delivery and distribution of polymer directly to and throughout a body cavity, allowing for complete and rapid coverage even in tortuous or poorly accessible spaces.
Physical characteristics such as hydrophilicity, hydrophobicity, expansion, density, softness, and viscosity can be tailored for optimal performance in limiting bodily fluid movement.
Foams are biocompatible, optionally biodegradable, and can be removed via surgical procedures or designed to degrade under external stimuli such as UV radiation or heat.
Foams can provide internal compression and support to tissues and organs without interfering with essential physiological functions such as respiration or cardiac output.
Foams can be functionalized to either adhere to tissues or minimize adhesion, supporting wound healing or preventing post-surgical tissue adhesions.
Documented Applications
Use of in situ formed polymer foams to control hemorrhage and stabilize bodily fluid loss in internal cavities, including abdominal, pelvic, and cardia thoracic cavities.
Treatment of incompressible hemorrhage from wound sites that are unknown or unable to be visualized within body cavities.
Providing internal support to organs or tissues such as the liver and spleen, especially in the treatment of damage from blunt trauma injury.
Filling body cavities created by the loss of body tissue or after surgical incisions.
Prevention of tissue adhesions (for example, to prevent fibrotic scars following surgery or injury in the abdomen, pelvis, spine, cardiothoracic space, and joints).
Drug delivery within or near wound sites via incorporation of drug-loaded objects in the foam or gel during administration.
Potential use to treat burns and other external wounds.
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