Systems and methods relating to medical applications of synthetic polymer formulations
Inventors
Donaldson, Ross I. • Fisher, Timothy • Buchanan, Oliver • Armstrong, Jon • Cambridge, John
Assignees
Publication Number
US-11207060-B2
Publication Date
2021-12-28
Expiration Date
2039-03-15
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Abstract
Systems, methods and compositions relating to delivering synthetic polymer formulations to the body are described, which can be used by a range of medical personnel including those with minimal experience and training. Under some embodiments, the present invention relates to systems and devices for delivering polymer formulations to a body cavity (e.g. peritoneal cavity) to reduce or stop bleeding. Under some embodiments, an initial percutaneous access pathway is first formed using a delivery device with a probe and needle mechanism that automatically stops the advance of the device upon insertion into a body cavity or space, thus minimizing user error and improving patient safety. The hollow probe then allows transmission of polymer, mixed with gas and/or additional substances, from a holding chamber or canister to flow through the device and hollow probe into the patient's anatomic cavity or space of interest, stopping expansion when the device senses the appropriate pressure. Once reaching the body cavity, the polymer formulation functions to reduce and/or stop bleeding.
Core Innovation
The invention provides systems, methods, and compositions for delivering synthetic polymer formulations to the body to reduce or stop bleeding, especially in body cavities such as the peritoneal cavity. The system is designed so that even minimally trained medical personnel can deploy it effectively and rapidly, increasing patient safety and minimizing user error. A key aspect includes a delivery device with a probe and needle mechanism that automatically stops advancing upon entering a body cavity, allowing for safe percutaneous access and reducing the risk of internal injury.
Once access is established, a hollow probe enables the transfer of a pressurized synthetic polymer formulation, which may be in the form of an aqueous solution, gel, or foam. This formulation can be mixed with a gas or other substances to create a stable and homogeneous solution that expands and foams upon entering the body cavity, thus exerting physical tamponade and delivering therapeutic agents. Pressure sensors or mechanical stops can automatically terminate the polymer’s delivery at a safe and therapeutically effective pressure.
The polymer formulations primarily feature copolymers of ethylene oxide and propylene oxide, such as poloxamers, which undergo a reverse phase change—remaining liquid at lower temperatures for easy delivery and forming a viscous gel at body temperature for hemostatic effect. The system addresses the challenge of effectively controlling noncompressible internal hemorrhage, particularly in pre-hospital or field environments where rapid intervention is critical and advanced surgical care may not be available. The invention also overcomes prior issues with removal and biocompatibility by enabling formulations that are resorbable or easily reversible by cooling.
Claims Coverage
There is one independent claim, which defines the primary inventive features focused on the formulation and delivery system for synthetic polymer hemostatic compositions.
Pressurized therapeutic composition with reverse phase copolymer and hydrofluorocarbon foaming agent
A pressurized therapeutic composition configured for storage and dispensing from a valved container, comprising: - An aqueous solution of a copolymer of ethylene oxide and propylene oxide at about 20–50% w/w, with the property of undergoing a reverse phase change from liquid to gel upon warming to body temperature. - A liquefied hydrofluorocarbon gas (at least 2.5% of the total mass), blended with the aqueous solution to form a stable, macroscopically homogeneous solution. - The liquefied gas causes the solution to foam upon dispensing due to evaporation after release from the container. - A testing apparatus is attachable to the pressurized valve container to permit the delivery of the therapeutic composition into a body cavity or penetrating wound.
The independent claim covers a storable, pressurized, and foaming therapeutic polymer solution suitable for body cavity or wound application, characterized by a reverse phase copolymer and hydrofluorocarbon blend, with corresponding delivery apparatus.
Stated Advantages
Enables rapid deployment by emergency personnel, including those with minimal training, to control hemorrhage in both pre-hospital and hospital environments.
Provides a safe, automatic stopping mechanism to prevent over-insertion and reduce the risk of organ injury during access to body cavities.
Formulation is resorbable or can be easily removed by cooling, eliminating the need for physical removal and minimizing complications.
Eliminates the requirement for refrigeration or external pre-cooling before use, utilizing the intrinsic cooling effect of the expanding gas for delivery.
A significantly smaller quantity of polymer is required to fill and tamponade a body cavity due to the expansive foaming, reducing heat loss and risk of hypothermia.
Allows for controlled delivery and maintenance of pressure within the treated cavity, enhancing hemostatic efficacy while minimizing risk of pressure-induced injury.
Compatible with additives such as procoagulant or antimicrobial agents, facilitating localized, potent therapy while minimizing systemic side effects.
Documented Applications
Delivery of synthetic polymer formulation to internal body cavities (such as the abdominal or peritoneal cavity) to reduce or stop bleeding, particularly from internal hemorrhage.
Use in emergency situations (including battlefield or mass casualty contexts) for rapid hemorrhage control by medical personnel with limited training.
Application for both internal and external hemorrhage management, including use in traumatic injuries, deep wounds, and body cavities.
Potential delivery of pharmaceutical agents (hemostatic, antibiotic, anesthetic, etc.) into body cavities or wounds using the synthetic polymer formulation as a carrier.
Use in various anatomical locations, including abdominal, thoracic, junctional, extremity, intravaginal, intrauterine, intracranial, intranasal, and abscess cavities.
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