Intra-abdominal pressure to promote hemostasis and survival
Inventors
Rago, Adam • Marini, John • Zugates, Gregory T. • Helmick, Marc • Sharma, Upma
Assignees
Publication Number
US-9820749-B2
Publication Date
2017-11-21
Expiration Date
2030-08-24
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Abstract
Systems, methods and kits for treating hemorrhages within cavities are provided. The methods utilize the application of a rapid spike of pressure to the closed cavity, followed by a steady state pressure or pressures.
Core Innovation
The invention provides systems, methods, and kits for treating hemorrhages within cavities by applying a rapid spike of pressure to a closed cavity, followed by a steady state pressure or pressures. The method includes applying pressure to an interior boundary of the cavity, including pressure to the injury itself, where the pressure is characterized by a transient peak value and at least one steady state value. Pressure may be applied by an article, such as in situ forming foam, which is formed inside the cavity by applying a formulation that includes at least one liquid phase into the cavity.
The background identifies that in situ forming polymer foams offer notable benefits for treating hemorrhage, especially in noncompressible or hard-to-access wounds, but their broad usage has been limited by technical challenges in developing suitable foaming formulations and delivering them in amounts effective for arresting hemorrhage without causing undesirable effects like compartment syndrome. There is additionally a need to extend survival times in challenging and remote settings long enough for patient evacuation. The invention addresses these problems by providing transient high pressure to quickly stop bleeding and a prolonged lower pressure to maintain hemostasis, improving clinical outcomes without inducing adverse effects such as compartment syndrome.
The inventive process also enables dose modulation and controllable pressure profiles, as both the transient spike and steady state pressures can be adjusted based on the formulation, quantity, and delivery mode. Although foam-based delivery is preferred, the invention contemplates utilizing other materials and systems capable of generating the described pressure profiles inside body cavities or by external constriction. The steady state pressure may persist long enough to allow transport and further medical intervention, thereby addressing critical needs in emergency and prehospital care.
Claims Coverage
There is one independent claim in the patent, which describes the main inventive feature of the method for treating hemorrhage within a body cavity.
Treating hemorrhage by applying pressure with in situ formed material characterized by a transient peak
The invention covers a method of treating hemorrhage within a cavity of a patient by: - Applying pressure to an interior boundary of the cavity. - The pressure is applied by an article placed into the cavity. - The pressure is characterized by a transient peak value. - The article is a material formed inside the cavity by applying a formulation comprising at least one liquid phase into the cavity. This inventive feature centers on the delivery and in situ formation of a material (such as a foam) that produces a controllable pressure profile for hemorrhage control.
The claim provides coverage for treating hemorrhage within body cavities through in situ formation of a pressure-applying material, distinguished by a transient peak pressure value achieved inside the target cavity.
Stated Advantages
Provides effective, dose-dependent hemorrhage control by rapidly raising and maintaining intra-cavity pressure to promote hemostasis and improve survival.
Reduces complications such as compartment syndrome by allowing both pressure spike and steady-state pressure to be regulated.
Does not require monitoring or feedback systems, as in situ forming foams create the desired pressure profiles automatically.
The foam system is portable and easily administered, suitable for challenging, remote, and prehospital settings.
Foam material is not readily absorbed or leaked, maintaining pressure without the need for continual material addition.
Documented Applications
Treatment of hemorrhage within body cavities, such as intra-abdominal hemorrhages.
Prevention or treatment of hemorrhage from noncompressible or difficult-to-visualize wounds.
Use in battlefield, rural, or wilderness environments where patients are far from hospital trauma centers.
Vascular embolization and treatment of conditions such as arteriovenous malformation, AV fistulas, or abdominal aortic aneurysm.
Space filling or bulking post-surgical resection or for cosmetic purposes.
Prevention of tissue adhesion, hernia repair, prevention or treatment of reflux, and temporary or permanent occlusion of body lumens for applications including sterilization and prevention of calculus migration during lithotripsy.
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