Method for preparing a haemostatic composition
Inventors
Hammershøj, Peter Lund • Larsen, Kristian • Johns, Douglas B. • Smith, Nicole • Cardinale, Michael • Ferrara, Gabriella • Zhang, Guanghui
Assignees
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Publication Number
US-11801324-B2
Publication Date
2023-10-31
Expiration Date
Abstract
The present disclosure relates to a method for preparing a haemostatic composition comprising thrombin, the method comprising the step of reconstituting a dry thrombin directly in a paste, such as a paste comprising a biocompatible polymer. The haemostatic composition comprising thrombin may be prepared from a dry thrombin composition and a paste in a single step operation and be used for treatment of a wound.
Core Innovation
The invention relates to a method of preparing a haemostatic composition in which a dry thrombin composition is provided in a first syringe and a paste comprising a biocompatible polymer is provided in a second syringe. The method connects the first syringe and the second syringe using a suitable connector and mixes the contents by transferring the contents between the syringes for 5 to 10 times.
In the described approach, dry thrombin is reconstituted directly inside the biocompatible polymer paste during the mixing step, rather than using a separate thrombin reconstitution step. The resulting haemostatic composition is specified to have a homogenous distribution of thrombin, with a variation in thrombin content throughout the haemostatic composition of less than 20%.
The described formulation constrains the biocompatible polymer content to 7% w/w to 20% w/w and specifies mixing performed by a limited number of transfers between the syringes. The disclosed examples report substantially homogeneous thrombin distribution after limited back-and-forth transfers and describe thrombin activity distribution across fractions to support the claimed homogeneity.
Claims Coverage
The document contains four independent claims that cover a method of preparing a haemostatic composition, a kit for preparing such a composition, and a method for reconstituting a dry thrombin composition using interconnectable syringes; across these claims, the composition is homogenous and thrombin-content variation is less than 20%, with mixing performed by transferring contents between syringes 5 to 10 times.
Two-syringe thrombin reconstitution mixing via connector
A method of preparing a haemostatic composition by providing a dry thrombin composition in a first syringe and a paste comprising a biocompatible polymer in a second syringe, connecting the syringes using a suitable connector, and mixing by transferring the contents between the syringes for 5 to 10 times.
Homogeneous thrombin distribution with limited variation
Producing a haemostatic composition having a homogenous distribution of thrombin and having a variation in thrombin content throughout the haemostatic composition of less than 20%.
Biocompatible polymer paste content constraint
Using a paste comprising the biocompatible polymer in a content of 7% w/w to 20% w/w in the second syringe.
Interconnectable syringes kit with instructions and variation target
A kit comprising a first syringe with a dry thrombin composition and a second syringe with a paste comprising a biocompatible polymer, optionally an outer package, and instructions for preparing a haemostatic composition by transferring contents between the syringes for 5 to 10 times to produce a haemostatic composition having a homogenous distribution of thrombin and a thrombin-content variation throughout of less than 20%.
Reconstitution of dry thrombin inside the mixed paste
A method for reconstituting a dry thrombin composition by providing a dry thrombin composition in a first syringe and a paste comprising a biocompatible polymer in a second syringe, connecting the syringes using a suitable connector, and mixing by transferring the contents between the syringes for 5 to 10 times.
Homogenous distribution of reconstituted thrombin with limited variation
Producing a haemostatic composition having a homogenous distribution of reconstituted thrombin and having a variation in thrombin content throughout the haemostatic composition of less than 20%.
Gelatin-specific biocompatible polymer embodiment
A method of preparing a haemostatic composition by providing a gelatin paste in a second syringe, wherein the paste comprises gelatin in a content of 7% w/w to 20% w/w, with a dry thrombin composition in a first syringe, connecting using a suitable connector, and mixing by transferring the contents between the syringes for 5 to 10 times.
Across the independent claims, the inventive subject matter centers on connector-based mixing between interconnectable syringes containing dry thrombin and a biocompatible polymer paste, including gelatin, using transferring the contents 5 to 10 times to obtain a haemostatic composition with homogenous thrombin distribution and thrombin-content variation less than 20%.
Stated Advantages
Faster preparation as compared to a control in an in vivo porcine spleen biopsy model, with reduced time to haemostasis (TTH).
Reduced number of steps, reduced handling/sterility risk, and cost reduction as stated in the provided patent summary.
Applicability to wound haemostasis/wound healing as described in the provided patent summary.
Documented Applications
In vivo haemostatic efficacy in a porcine spleen biopsy model, where the prepared paste is compared against a control (Surgiflo) with reported time to haemostasis (TTH).
Use for wound haemostasis/wound healing as described in the provided patent summary.
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