In situ forming hemostatic form implants
Inventors
Sharma, Upma • Gitlin, Irina • Zugates, Gregory T. • Rago, Adam • Zamiri, Parisa • Busold, Rany • Freyman, Toby • Caulkins, Robert J. • Pham, Quynh P. • You, Changcheng • Carbeck, Jeffrey D.
Assignees
Publication Number
US-11786642-B2
Publication Date
2023-10-17
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 the preparation and in situ formation of polymer foams within a body cavity for preventing or limiting movement of bodily fluids, such as blood. The process involves introducing a flowable polymer formulation—often as a combination of two components—into a body cavity, followed by in situ foaming and cross-linking to create an elastomeric, often biodegradable and biocompatible, polymer foam. The resulting foam expands within the cavity and exerts pressure on internal surfaces, effectively stemming the flow of bodily fluids.
The problem addressed by the invention is the challenge of controlling internal bleeding, especially in situations where traditional hemorrhage control techniques (such as direct pressure) are impractical or impossible, such as internal wounds within tortuous or non-compressible body cavities. Previous polymer-based solutions often suffered from inadequate mechanical properties, biocompatibility, biodegradability, or were difficult to place within the body.
The invention solves these deficiencies by providing foams that can be formed in situ, conform to the geometry of the cavity, and possess tunable physical and chemical properties. These may include controlled viscosity for deployment, rapid and tailored cross-linking and foaming kinetics, custom mechanical properties, hydrophilicity or hydrophobicity, and the ability to adhere—covalently or non-covalently—to tissue, while being removable or degradable as required. The materials and methods thereby enable both the rapid control of bleeding and potential use for preventing tissue adhesions, supporting damaged organs, delivering drugs, and sealing wounds, all without requiring site-specific placement knowledge.
Claims Coverage
The patent claims cover a method of treating a patient by forming a polymer foam in situ within a body cavity for controlling the flow of a bodily fluid, comprising specific inventive features related to formulation, delivery, foaming, and functional characteristics.
In situ formation of polymer foam by combining two polymer components and blowing agent
A method where a first component comprising a first polymer is combined with a second component comprising a second polymer to form a polymer formulation, which is then introduced, together with a blowing agent, into a patient's body cavity for polymer foam formation.
Introduction and control of blowing agent during foam formation
The method includes introducing the blowing agent either separately or together with the polymer formulation into the body cavity, allowing the blowing agent to permeate the formulation and form bubbles, which are then fixed by crosslinking the polymers to generate a porous foam.
Tunable foaming and cross-linking parameters for clinical efficacy
The claimed method specifies key parameters such as volume expansion ranging from 12-fold to 40-fold, foam hydrophobicity, rise time of 150 seconds or less, cream time of 10 seconds or greater, and formulation viscosity less than 1200 cP. Crosslinking may be catalyzed by an initiator or by contact with an aqueous solution, including blood.
Formation of biodegradable polymer foams exerting mechanical pressure to limit fluid movement
The resulting foam is designed to be biodegradable and to exert pressure on the internal cavity surface, thereby at least partially limiting the movement of bodily fluids within the cavity. The polymer foam structure is characterized by the presence of a plurality of pores formed around gas bubbles.
Inclusion of formulation additives to tailor foam properties
The method allows for each polymer component to optionally include additives such as surfactants, chain extenders, plasticizers, fillers, or pore openers, enabling detailed customization of foam properties for patient-specific or clinical requirements.
Collectively, the inventive features establish a method for in situ formation of a customizable, biodegradable polymer foam in a body cavity, with control over foaming, cross-linking, and material properties to effectively limit the flow of bodily fluids and adapt the foam to specific medical needs.
Stated Advantages
The polymer foams can be deployed into a closed body cavity without requiring specific knowledge of injury site(s) while conforming to and contacting actively bleeding wounds throughout the cavity.
Foams of the invention can reach sites of injury located within tortuous body cavities, around or across anatomical features, through pooled blood, and/or against the flow of blood.
The foams are designed to not interfere with physiological functions such as respiration or cardiac output, due to their softness and compressibility.
Foams facilitate hemostasis by providing internal compression, reducing flow, and promoting blood clot formation with a structure resistant to fluid flow.
The foams may be biocompatible, bioabsorbable, can be removed with standard surgical procedures, and do not induce adhesions.
The viscosity, expansion, and kinetics of the formulation can be tailored for optimal dispersal and coverage within a body cavity.
Foams permit visualization or imaging of a body cavity by interaction with contrast agents.
Polymer foams may be used to provide support to organs or tissues damaged by trauma.
The invention allows for delivery of active agents or drugs together with the foam.
Documented Applications
Control of bleeding within internal body cavities, including the abdominal, pelvic, and cardiothoracic cavities, especially for incompressible hemorrhage where wound sites are unknown or not visualized.
Support and stabilization of organs or tissues (such as liver and spleen) damaged in blunt trauma injuries.
Filling body cavities created by loss of body tissue.
Treatment of open wounds or surgical incisions, including use in body cavities exposed to the external environment.
Prevention of tissue adhesions (such as fibrotic scars) following injury or surgical intervention in regions including the abdomen, pelvis, spine, cardiothoracic space, and joints.
Delivery of drugs such as antifibrinolytic compounds, antibiotics, anti-inflammatory compounds, analgesics, pro-coagulant compounds, growth factors, and vasoconstrictors into a body cavity.
Visualization of body cavities using polymer foams that can interact with contrast agents for imaging.
Formation of a seal at the site of injury by the foam conforming to and adhering to tissue.
Removal of foam by surgical intervention or degradation (via external stimulus such as UV, heat, or chemicals) after it has served its function.
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