Stabilizers for hemostatic products

Inventors

Olson, Curtis E. • Messina, Philip A.

Assignees

St Teresa Medical Inc

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Publication Number

US-8697118-B2

Patent

Publication Date

2014-04-15

Expiration Date


Abstract

A hemostatic product that includes a dextran support, at least one hemostatic agent and at least one hemostatic agent stabilizer. The at least one hemostatic agent is selected from the group consisting of thrombin and fibrinogen. The at least one hemostatic agent is associated with the dextran support. The at least one hemostatic agent stabilizer is associated with the at least one hemostatic agent.

Core Innovation

The invention relates to hemostatic products that include a dextran support. A hemostatic agent stabilizer mixture is provided, and the hemostatic agent stabilizer mixture comprises sucrose and dextran. A hemostatic mixture that comprises at least one hemostatic agent selected from thrombin and fibrinogen is applied to the dextran support.

The hemostatic agent stabilizer mixture is described as being used to stabilize thrombin and/or fibrinogen, including by reducing breakdown and improving shelf life. The description further addresses resistance to elevated temperature and radiation, and includes a solubility-enhancing agent associated with the stabilizer mixture, including non-ionic surfactant Pluronic and detergent.

The hemostatic product is described in connection with dextran as a dissolvable support for releasing active agents at a wound site. The description discusses support/backing materials and structures configured to direct release into deep penetrating wounds, including hemostatic particulate/protective formulations and support/backing materials.

Claims Coverage

The partial content provides one independent claim. The independent claim covers a dextran support with a sucrose/dextran hemostatic agent stabilizer mixture and a hemostatic mixture including thrombin and/or fibrinogen applied to the dextran support.

Dextran support with sucrose/dextran stabilizer

A dextran support; and a hemostatic agent stabilizer mixture comprising sucrose and dextran.

Hemostatic mixture applied to dextran support

A hemostatic mixture comprising the hemostatic agent stabilizer mixture and at least one hemostatic agent selected from thrombin and fibrinogen, wherein the hemostatic mixture is applied to the dextran support.

The claim coverage is centered on combining a dextran support with a sucrose/dextran hemostatic agent stabilizer mixture and applying a hemostatic mixture containing thrombin and/or fibrinogen to that dextran support.

Stated Advantages

Reduces breakdown of thrombin and/or fibrinogen and improves shelf life.

Provides resistance to elevated temperatures and radiation.

Enables rapid dissolution of dextran at wound sites to release active agents.

Demonstrates faster hemostasis and fewer additional compressions versus TACHOSIL in swine liver injury model comparisons.

Documented Applications

Hemostatic use in a swine liver injury model, compared against TACHOSIL, with reported faster hemostasis and fewer additional compressions.

Hemostatic efficacy evaluation for clot strength/clot efficacy using an in vitro Rheostress rheometer comparison.

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