Device for promotion of hemostasis and/or wound healing
Inventors
Larsen, Kristian • Sabra, Mads
Assignees
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Publication Number
US-9533069-B2
Publication Date
2017-01-03
Expiration Date
Abstract
Disclosed is a matrix material comprising a pharmaceutical composition such as a matrix material with a pharmaceutical composition printed on the surface. In one embodiment the pharmaceutical composition comprises thrombin. Further disclosed is a method for making the matrix material with a pharmaceutical composition printed on the surface and use of said matrix material for promotion of hemostasis and/or wound healing. Also disclosed is a kit-of-parts comprising a matrix with a pharmaceutical composition and a container with a peelable lid.
Core Innovation
The invention relates to a hemostatic matrix material comprising a surface and a plurality of open and interconnected cells, wherein the matrix material comprises gelatin or collagen. The surface includes a single hemostatic composition consisting of thrombin distributed in a uniform manner, and the surface contains between 8 and 50 IU/cm2 of thrombin.
The disclosure also describes thrombin distribution constraints across area units and deposition at discrete locations on the matrix surface, including precision printing such as inkjet using droplets. In some embodiments, thrombin may be used alone or together with fibrinogen, Factor XIII, and/or tranexamic acid, and the disclosure further includes sterile storage and preparation in a container/kit.
The disclosed container/package embodiments include lid and base/container dimensional options and container/package shapes, including square and circular configurations and named examples of container shapes such as “Teacup100”, “Teacup50”, and “Teacup12-7”. The package design further specifies sealing surface configurations and material options for medical-grade plastics and specific polymer families, together with peelable and/or reclosable features for sterile field settings.
Claims Coverage
The independent claims are directed to a hemostatic matrix material and two related methods for applying the matrix to a wound to promote wound healing or promote hemostasis. Across the independent claims, the coverage centers on a gelatin or collagen open-cell matrix with a single uniformly distributed thrombin-based composition on the surface, with a defined surface thrombin loading between 8 and 50 IU/cm2.
Open-cell gelatin or collagen hemostatic matrix with defined surface
A hemostatic matrix material comprising a surface and a plurality of open and interconnected cells, the matrix material comprising gelatin or collagen.
Single uniformly distributed thrombin composition on the surface
The surface of the matrix material has a single hemostatic composition consisting of thrombin distributed in a uniform manner.
Surface thrombin loading between 8 and 50 IU/cm2
The surface of the matrix material contains between 8 and 50 IU/cm2 of thrombin.
Applying the matrix to promote wound healing
Applying to a wound a hemostatic matrix material comprising a surface and a plurality of open and interconnected cells, the matrix material comprising gelatin or collagen, wherein the surface has a single hemostatic composition consisting of thrombin distributed in a uniform manner, and the surface contains between 8 and 50 IU/cm2 of thrombin.
Applying the matrix to promote hemostasis
Applying to a wound a hemostatic matrix material comprising a surface and a plurality of open and interconnected cells, the matrix material comprising gelatin or collagen, wherein the surface has a single hemostatic composition consisting of thrombin distributed in a uniform manner, and the surface contains between 8 and 50 IU/cm2 of thrombin.
Overall, the claims coverage ties both the product and its wound application to the same core structural and compositional constraints: a gelatin or collagen matrix with open and interconnected cells; a single thrombin-based hemostatic composition on the surface; uniform thrombin distribution; and a surface loading between 8 and 50 IU/cm2.
Stated Advantages
Improved mouldability.
Post-absorption distribution of the pharmaceutical composition.
Sticky dry application effect.
Improved uniformity versus spraying.
Controlled deposition at discrete locations on the matrix surface.
Rapid droplet evaporation while avoiding swelling.
Operational/usage advantages in sterile field settings for the medical container/package embodiments.
Documented Applications
Promoting wound healing in an individual in need thereof by applying the hemostatic matrix material to a wound.
Promoting hemostasis in an individual in need thereof by applying the hemostatic matrix material to a wound.
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