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-12059141-B2
Publication Date
2024-08-13
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 relates to systems, methods, and compositions for delivering synthetic polymer formulations to the body, particularly for reducing or stopping bleeding in body cavities such as the peritoneal cavity. The system includes a pressurized therapeutic composition made of an aqueous solution of copolymers of ethylene oxide and propylene oxide (e.g., poloxamers), which undergo a reverse phase change from liquid to gel upon warming, combined with a liquefied hydrofluorocarbon gas serving as a propellant to create a foam when dispensed. The composition is stored in a valved, pressurized container and delivered through an apparatus to targeted areas.
The core problem solved relates to the inability to rapidly and safely stop severe internal bleeding, especially in environments lacking specialized medical personnel or facilities. Existing methods either require skilled surgical intervention, present risks of further tissue injury (such as naked needle insertion), cannot be applied in certain trauma types (like blunt abdominal trauma), or use solidifying agents with difficult removability and potential complications. There is also a need for a hemostatic system that can be effectively deployed by personnel with minimal training in both in-hospital and out-of-hospital settings, including battlefield and mass casualty scenarios.
The innovation addresses these deficiencies by providing a polymer formulation that is easily and safely deliverable via a system that minimizes user error and maximizes patient safety through automated mechanisms. The polymer, mixed with liquefied gas, is dispensed as a foam that rapidly fills the desired cavity to provide physical tamponade and hemostasis. The system can include controls to regulate pressure and volume, preventing injury from over-pressurization. The formulation is resorbable or easily removable by cooling, does not require chemical reaction with body fluids, and can incorporate additional therapeutic agents such as procoagulants or antimicrobials for enhanced effect.
Claims Coverage
There are two independent claims, each covering the main technical compositions and delivery characteristics of the invention.
Therapeutic composition with reverse phase copolymer and liquefied hydrofluorocarbon gas forming foam
A pressurized therapeutic composition designed for storage in a valved container, consisting of: - An aqueous solution of a copolymer of ethylene oxide and propylene oxide (over about 5% w/w) that undergoes a reverse phase change from liquid to gel upon warming. - A liquefied hydrofluorocarbon gas (at least 2.5% of total mass) blended with the aqueous solution to create a stable, macroscopically homogeneous solution. - Upon dispensing from the pressurized container, the liquefied gas evaporates, causing the solution to foam. - An apparatus is configured to attach to the container for delivery to an external wound or area.
Variation in therapeutic composition concentration range and delivery
A pressurized therapeutic composition comprising: - An aqueous solution of a copolymer of ethylene oxide and propylene oxide between about 20% and 50% w/w. - A liquefied hydrofluorocarbon gas comprising at least 2.5% of the composition's mass, blended into a stable, homogeneous solution. - The composition foams upon dispensing due to gas evaporation. - An apparatus attachable to the pressurized container is configured to deliver the composition to an external wound or area.
The independent claims are directed to a foaming, pressurized therapeutic composition based on a copolymer solution and liquefied hydrofluorocarbon propellant, configured for safe and controlled delivery to external wounds or body areas through a specialized apparatus.
Stated Advantages
The polymer formulation can be rapidly and safely administered to control bleeding without requiring skilled surgical personnel.
The system minimizes user error and risk of injury by employing automated mechanisms that stop device advancement upon cavity entry and regulate expansion pressure.
The composition is resorbable or can be easily removed by cooling, eliminating the need for surgical removal of solid agents.
Foam expands to fill a cavity using propellant rather than a chemical reaction with body components, facilitating rapid and effective hemostasis.
Treatment can be deployed by minimally trained personnel in field conditions, including battlefield and mass casualty scenarios.
The required quantity of polymer solution is reduced compared to non-foaming versions, decreasing thermal load on patient tissues.
The system and formulation can incorporate high local concentrations of additional hemostatic or antimicrobial agents for enhanced localized therapeutic effect.
The foam's reverse phase change properties allow it to flow as a liquid during delivery and gel within the body, enhancing tamponade and removability.
The system is stable without refrigeration and suited for field adaptation, including compatibility with medical field kits and extreme environments.
Documented Applications
Delivery of synthetic polymer foam into body cavities, such as the peritoneal cavity, to reduce or stop internal bleeding.
Use in both out-of-hospital and in-hospital environments, including by emergency and battlefield personnel.
Use for treating non-compressible hemorrhage (e.g., intra-abdominal, thoracic, junctional areas).
Application for external bleeding by administering the composition to external wounds or areas.
Delivery of additional bioactive substances, such as clotting agents or antibiotics, directly to affected body cavities or wounds.
Potential use in large-volume body cavities, and adaptation of system for other anatomical spaces, including thoracic cavity, junctional wounds, intravaginally, intrauterine, intracranially, intranasally, and abscesses.
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