Highly efficacious hemostatic adhesive polymer scaffold
Inventors
Landolina, Joseph A. • Ahmad, Omar M.
Assignees
Publication Number
US-12016968-B2
Publication Date
2024-06-25
Expiration Date
2035-06-22
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Abstract
The invention relates to biocompatible polymer gel compositions useful in facilitating and maintaining hemostasis. The biocompatible polymeric gel composition is comprised of (a) one or more than one polyanionic polymer, (b) one or more than one polycationic polymer, and (c) a solvent. A preferred composition includes sodium alginate, chitosan, and water to produce an adhesive hemostatic device that is useful in facilitating and maintaining rapid hemostasis.
Core Innovation
The invention describes a class of biocompatible polymer gel compositions formulated to facilitate and maintain hemostasis. The primary components of the composition are one or more polyanionic polymers, one or more polycationic polymers, and a solvent. A particularly preferred embodiment utilizes sodium alginate as the polyanionic polymer, chitosan as the polycationic polymer, and water as the solvent, forming an adhesive hemostatic device that supports rapid blood clotting.
A key problem addressed by this invention is the challenge of adhesion for hemostatic devices, especially when faced with sustained or strong blood flow. Conventional dry devices may dehydrate wounds and impede healing, leading to poor adhesion and risk of premature plug or clot disengagement. This invention provides an adhesive hemostatic device that does not limit wound hydration during and after hemostasis, maintaining both strong adhesive properties and a hydrated wound environment.
The invention emphasizes that properties such as chain length, molecular weight, particle size, viscosity, and morphology of the chosen polymers, as well as the method of manufacturing and component ratio, impact the final product's performance. The compositions are characterized by high hemostatic efficiency, strong adhesion, and rapid clotting ability, and their properties and efficacy are validated by standard clotting tests and physical measurement. The composition’s effectiveness is enhanced by careful selection and formulation of sodium alginate and chitosan, and by specifically preventing simultaneous mixing of all components to ensure proper gel formation and performance.
Claims Coverage
The patent includes three independent claims, each directed to a distinct inventive feature relating to the composition, method of making, and method of use.
Polymeric composition comprising specific ratios and properties of sodium alginate, chitosan, and water
The composition includes: - About 50% to about 94% by weight of water. - About 1% to about 5% by weight of sodium alginate having a molecular weight between about 500 kDa and about 900 kDa, dissolved in water. - About 5% to about 40% by weight of solid chitosan particles with an average particle size between about 50 mesh and about 500 mesh and an average degree of deacetylation of between about 75.0% to about 99.0%. This composition is formulated to exhibit hemostatic efficacy and maintain strong adhesive properties.
Method of making the polymeric composition by sequential mixing
A process involving: 1. Mixing sodium alginate (molecular weight between about 500 kDa and about 900 kDa) in water to dissolve and form a solution. 2. Dispersing solid chitosan particles (average particle size between about 50 mesh and about 500 mesh and average degree of deacetylation between about 75.0% to about 99.0%) into the sodium alginate solution to form the polymeric composition. The method entails sequential, not simultaneous, incorporation of components to ensure homogeneity and gel efficacy.
Method of facilitating and maintaining hemostasis in a subject by applying the composition
A method for facilitating and maintaining hemostasis in a subject by applying the aforementioned polymeric composition at a bleed site. The method specifically includes use for stopping arterial, venous, dental, or oral bleeds. The subject may be a mammal, marine animal, reptile, or human, and the application methods include use via gauze, catheter, or syringe.
The inventive features provide coverage of a novel hemostatic polymeric composition with defined physical and chemical characteristics, a sequential manufacturing process to ensure product quality, and a medical method of use for rapid and effective bleeding control.
Stated Advantages
The composition facilitates and maintains rapid hemostasis, achieving faster clotting than without the composition.
It exhibits strong adhesive properties without limiting wound hydration during and after hemostasis.
The formulation produces a strong clot capable of resisting fracture and blood passage.
The composition is biocompatible and can be made sterile and suitable for humans and animals.
The gel form conforms to wound topology better than solids, aiding hemostasis and wound coverage.
Documented Applications
Facilitating and maintaining hemostasis in various wounds including external lacerations, abrasions, burns, ocular lacerations, parenchymal organ damage, internal lacerations, gastrointestinal tract lacerations, superficial cuts and scrapes, internal bleeding, arterial and venous bleeds, and dental or oral bleeds and incisions.
Application to wound sites in a range of subjects including humans, mammals, marine animals, and reptiles.
Use during surgical procedures, including dispensing via catheter in laparoscopic procedures or across gauze pads for large surface bleeds.
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