Intra-abdominal pressure to promote hemostasis and survival

Inventors

Rago, AdamMarini, JohnZugates, Gregory T.Helmick, MarcSharma, Upma

Assignees

Arsenal Medical Inc

Publication Number

US-10653422-B2

Publication Date

2020-05-19

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 body cavities through the application of pressure that is characterized by a rapid, transient peak followed by a steady state value. This pressure is preferably applied using an in situ forming foam, formed inside the cavity by delivering a formulation containing at least one liquid phase. The resulting foam exerts a pressure on the interior boundary of the body cavity, including at the site of injury.

A critical feature of the approach involves delivering enough pressure to achieve a high, short-lived spike (transient peak) followed by a sustained but lower (steady state) pressure. The transient peak is typically between 14 mmHg and 86 mmHg, and the steady state pressure ranges from about 12 mmHg to 28 mmHg. These pressure profiles are achieved through carefully selected foam formulations and dosages, with administration tailored to the size of the body cavity and the type of hemorrhage.

The invention addresses the problem that, although in situ forming foams have clear promise for controlling noncompressible and difficult-to-access hemorrhages, their use has been limited due to challenges in developing safe and effective formulations. Specifically, there is a need to arrest hemorrhages without causing excessive pressure and related complications such as compartment syndrome, while sustaining pressure long enough to enable patient transport to surgical care. The present invention achieves this goal by combining optimal pressure kinetics with suitable foam material properties and delivery systems.

Claims Coverage

The patent includes one independent claim, which defines the main inventive features of the kit for treating hemorrhage in a cavity.

Kit comprising a foam-forming formulation and instructions for hemorrhage treatment

The invention covers a kit designed to treat hemorrhage in a body cavity. - The kit includes a formulation comprising at least one liquid phase, which forms a foam when delivered into the cavity of a patient. - The foam, upon formation, exerts a pressure on the interior boundary of the cavity that is characterized by a transient peak value. - The kit further includes instructions instructing a user in the application of the formulation.

In summary, the inventive feature centers on a kit that combines a foam-forming formulation designed to produce a pressure profile with a transient peak, and user instructions for treating hemorrhage in a body cavity.

Stated Advantages

Provides effective treatment for noncompressible or difficult-to-visualize hemorrhages within body cavities by delivering pressure profiles that rapidly arrest bleeding and maintain hemostasis.

Permits patient survival to be extended long enough to allow evacuation to medical facilities for surgical treatment.

Foam system is portable, easily administered, does not require monitoring or feedback systems, and does not require repeated addition of material to sustain pressure.

Reduces the risks of complications such as compartment syndrome by optimizing transient peak and steady state pressures.

In situ foams expand to fill cavities, support tissues, conform to anatomy, and provide a steady, non-leaking intra-cavity pressure source.

Documented Applications

Treatment of noncompressible hemorrhages in closed body cavities, including the abdominal cavity, especially in challenging, remote, or battlefield settings.

Prevention or treatment of hemorrhage in situations where wounds are difficult to access or visualize.

Use in animal models and confirmed pressure profiles in recently deceased human subjects indicating potential for human clinical applications in similar scenarios.

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