Hemostatic agent and method
Inventors
Roberts, Keith A. • Burban, John Henry • Zia, Majid • Spearman, Michael R.
Assignees
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Publication Number
US-10744310-B2
Publication Date
2020-08-18
Expiration Date
Abstract
A sponge including one or more hemostatic agents and one or more binding agents. At least one of the hemostatic agents is a pregelatinized potato starch. The collective percentage by weight of the one or more hemostatic agents is within the range of approximately one eighth to approximately sixteen times as great as the collective percentage by weight of the one or more binding agents.
Core Innovation
The described invention is a hemostatic sponge that uses one or more hemostatic agents in which at least one hemostatic agent comprises pregelatinized potato starch. The sponge also includes one or more binding agents, and the collective percentage by weight of the hemostatic agents is constrained relative to the collective percentage by weight of the binding agents.
The invention further specifies formulation constraints that set the relative weight contributions of the hemostatic agents and binding agents. In one range, the collective percentage by weight of the one or more hemostatic agents is within approximately one eighth to approximately sixteen times as great as the collective percentage by weight of the one or more binding agents. In another formulation, the collective percentage by weight of the one or more binding agents is within approximately one quarter to approximately equal to the collective percentage by weight of the one or more hemostatic agents.
The disclosed sponge may be configured as a porous and flexible material that can be bent without cracking, and it may be attached to a wound portion of a bandage. Optional components include clotting accelerators selected from calcium chloride, prothrombin, and vitamin K, and optional medications including antibacterials, antifungals, and polyglucans.
Claims Coverage
The independent claim set includes three independent claims that center on a sponge comprising a hemostatic agent with pregelatinized potato starch and one or more binding agents, together with specific quantitative weight-percentage relationships. Across the independent claims, the binding-agent identity and optional clotting accelerator/structural features are variably incorporated, resulting in multiple inventive-feature combinations.
Pregelatinized potato starch hemostatic agent
The sponge comprises one or more hemostatic agents, wherein at least one of the hemostatic agents comprises a pregelatinized potato starch.
Hemostatic-to-binding weight ratio constraint (about 1/8 to about 16×)
The collective percentage by weight of the one or more hemostatic agents is within the range of approximately one eighth to approximately sixteen times as great as the collective percentage by weight of the one or more binding agents.
Binding-agent selection with clotting accelerator and about 1/4 to about equal ratio
The sponge includes one or more binding agents selected from polyethylene glycol, glycerol, sorbitol, erythritol, propylene glycol, pentaerythritol, glycerol esters, hydroxypropylmethyl cellulose (HPMC), hydroxypropylcellulose (HPC), hydroxypropylethylcellulose (HPEC), xanthum gum, and guar gum, and a clotting accelerator selected from calcium chloride, prothrombin, and vitamin K, wherein the collective percentage by weight of the one or more binding agents is within the range of approximately one quarter to approximately equal to the collective percentage by weight of the one or more hemostatic agents.
Binding-agent weight ratio constraint (about 1/4 to about equal)
The collective percentage by weight of the one or more binding agents is within the range of approximately one quarter to approximately equal to the collective percentage by weight of the one or more hemostatic agents.
Overall claim coverage is directed to a sponge using pregelatinized potato starch as at least one hemostatic agent, combined with specified binding agents and quantitative hemostatic/binding weight-percentage relationships. Dependent claim refinements further narrow the sponge with examples of binding-agent options, optional clotting accelerators and medications, and structural/usage characteristics such as flexibility and attachment to a bandage wound portion.
Stated Advantages
Provides a sponge that is flexible enough to be bent in half without cracking.
Improves absorption as supported by an experimental viscosity/water-absorption test.
Provides a flexible hemostatic sponge architecture intended for effective wound contact/pressure through removable covers and, in one embodiment, a pressure-applier plunger.
Documented Applications
Treatment involving wound contact, including wound exudate treatment.
Use in oral surgery gums.
Nasal bleeding treatment, including insertion into a nose.
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