Intra-abdominal pressure to promote hemostasis and survival
Inventors
Rago, Adam • Marini, John • Zugates, Gregory T. • Helmick, Marc • Sharma, Upma
Assignees
Publication Number
US-10293076-B2
Publication Date
2019-05-21
Expiration Date
2031-08-12
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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 addresses the need for effective treatment of hemorrhages within body cavities, particularly noncompressible or difficult-to-access wounds, by providing systems, methods, and kits that utilize the application of a rapid spike of pressure to a closed cavity, followed by a steady state pressure. The key innovation is to apply a transient high pressure that acts quickly and directly at the injury site, succeeded by a lower, sustained pressure to maintain hemostasis and promote survival. The method can be performed by introducing a material, such as in situ forming foams, gels, elastomeric solids, or reverse thermosensitive polymer materials, into the cavity.
The problem identified in the background is that while in situ forming polymer foams have shown potential in controlling hemorrhage, their use has been limited by challenges related to achieving sufficient efficacy without causing negative side effects, such as excessive pressure leading to compartment syndrome. Additionally, the need exists for systems capable of prolonging patient survival long enough for surgical intervention, especially in challenging environments like battlefields or remote areas.
This invention overcomes previous limitations by generating temporal pressure profiles consisting of a rapid transient spike (between 14 mmHg and 86 mmHg) and an extended steady state pressure (between 12 mmHg and 28 mmHg), using selected materials able to expand and conform to the cavity. The method may use in situ forming foams, which provide immediate physical pressure, are portable, and can be tailored in dose and formulation for the specific patient and application. Kits are also disclosed that include a suitable material and instructions for use, enabling practical implementation for hemorrhage control in various settings.
Claims Coverage
There are two independent claims in this patent, covering a method for treating a hemorrhage within a cavity and a kit for treating hemorrhage in a cavity of a patient.
Method for treating a hemorrhage within a cavity using pressure profiles
This inventive feature is based on a method for treating a hemorrhage within a cavity by applying a pressure to the interior boundary of the cavity. - The pressure is applied by introducing a material to the interior boundary of the cavity. - The material is selected from the group consisting of a gel, an elastomeric solid, a pre-formed foam, combination of a foam and liquid, combination of a foam and gas, and reverse thermosensitive polymer materials. - The pressure is characterized by a transient peak value and at least one steady state value.
Kit for treating hemorrhage in a cavity with pressure-inducing material and instructions
This inventive feature is a kit for treating hemorrhage in a cavity of a patient, comprising: - A material configured to apply pressure to an interior boundary of a body cavity. - The material is selected from the group consisting of a gel, an elastomeric solid, a pre-formed foam, combination of a foam and liquid, combination of a foam and gas, and reverse thermosensitive polymer materials. - Instructions for performing a method of applying the material to produce a transient peak pressure followed by at least one steady state pressure.
In summary, the claims cover both the method of treating hemorrhage in a cavity using specific pressure profiles via application of selected materials, and a kit enabling this method with both the pressure-inducing material and instructions for its use.
Stated Advantages
Provides a rapid, transient application of high pressure to effectively stop hemorrhage, followed by a lower steady-state pressure to maintain hemostasis.
Enables treatment of noncompressible or difficult-to-access hemorrhages in challenging settings such as the battlefield or remote locations.
Foam systems are portable, easily administered, and do not require monitoring or feedback systems.
Foam material does not readily leak or get absorbed, allowing sustained pressure without the need for additional material.
May be tailored in dose and formulation to suit different applications and patient anatomies.
Documented Applications
Treatment of hemorrhage within closed body cavities, including abdominal cavity, junctional hemorrhage, pelvic hemorrhage, or pseudocavities.
Prehospital or emergency treatment of noncompressible or difficult-to-visualize wounds to bridge time until surgical intervention.
Use in military, wilderness, or rural settings where immediate surgical treatment is not available.
Space filling and bulking after surgical resection or for cosmetic purposes.
Prevention of tissue adhesion and hernia repair.
Prevention or treatment of reflux and temporary or permanent occlusion of body lumens, including applications such as sterilization or prevention of calculus migration during lithotripsy.
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