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Publication Number
US-9999703-B2
Publication Date
2018-06-19
Expiration Date
Abstract
The present invention relates to a dry composition, which upon addition of an aqueous medium forms a substantially homogenous paste suitable for use in haemostasis procedures. The paste forms spontaneously upon addition of the liquid, hence no mechanical mixing is required for said paste to form. The invention further relates to methods of preparing said dry composition, a paste made from said dry composition and use of said paste for medical and surgical purposes.
Core Innovation
The invention relates to a dry composition suitable for use in haemostasis and wound healing. The composition comprises a frozen paste that has been freeze-dried, and includes a biocompatible polymer and from about 10% w/w to about 60% w/w of one or more polyols selected from sugar alcohols and sugars. The dry composition is obtained by providing a cross-linked biocompatible polymer in powder form, one or more polyols, and an aqueous medium, mixing to obtain a paste, and freeze-drying the paste.
The dry composition is capable of reconstituting to form a substantially homogeneous paste without mechanical mixing. The dry, freeze-dried product is configured to reconstitute upon the addition of water, while avoiding mechanical mixing during reconstitution. The cross-linked biocompatible polymer and the selected polyol component are combined in the dry formulation so that the resulting reconstituted product forms a homogeneous haemostatic paste.
The invention further covers delivery formats for haemostasis and wound healing, including a haemostatic kit with a container holding the dry composition and a container holding an aqueous medium, optionally with outer packaging. Additional embodiments include a syringe or applicator comprising the dry, freeze-dried composition for dispensing. Specific embodiments are described using crosslinked gelatine as the biocompatible polymer together with sugar alcohols and sugars as the polyols.
Claims Coverage
The document provides four groups of independent claims: a dry haemostatic composition for haemostasis and wound healing, a haemostatic kit, and syringe/applicator formats, including specific crosslinked gelatine variants. Across the independent claims, the inventive features consistently focus on a freeze-dried reconstitutable dry composition derived from a frozen paste, containing a cross-linked biocompatible polymer and a defined polyol fraction selected from sugar alcohols and sugars, with reconstitution to a substantially homogeneous paste without mechanical mixing.
Freeze-dried reconstitutable dry haemostatic paste without mechanical mixing
A dry composition suitable for use in haemostasis and wound healing comprising a frozen paste that has been freeze-dried, wherein the dry composition is capable of reconstituting to form a substantially homogeneous paste without mechanical mixing.
Cross-linked biocompatible polymer powder with polyols selected from sugar alcohols and sugars
The dry composition comprises a biocompatible polymer and from about 10% w/w to about 60% w/w of one or more polyols, wherein the one or more polyols are selected from sugar alcohols and sugars, and wherein the dry composition is obtained by providing a cross-linked biocompatible polymer in powder form, one or more polyols and an aqueous medium.
Sequential preparation by mixing to paste and freeze-drying
The dry composition is obtained by mixing the biocompatible polymer, the one or more polyols and the aqueous medium to obtain a paste, and freeze-drying the paste to produce a dry composition.
Haemostatic kit with dry container and aqueous medium container
A haemostatic kit comprising a container comprising a dry composition comprising a frozen paste that has been freeze-dried and a container comprising an aqueous medium, wherein the dry composition includes a biocompatible polymer and from about 10% w/w to about 60% w/w of one or more polyols selected from sugar alcohols and sugars and is capable of reconstituting to form a substantially homogeneous paste without mechanical mixing.
Syringe or applicator containing the reconstitutable freeze-dried dry composition
A syringe or applicator comprising a dry composition comprising a frozen paste that has been freeze-dried, wherein the dry composition includes a biocompatible polymer and from about 10% w/w to about 60% w/w of one or more polyols selected from sugar alcohols and sugars and is capable of reconstituting to form a substantially homogeneous paste without mechanical mixing.
Crosslinked gelatine with polyols selected from sugar alcohols and sugars
A dry composition suitable for use in haemostasis and wound healing comprising a frozen paste that has been freeze-dried, wherein the dry composition comprises crosslinked gelatine and from about 10% w/w to about 60% w/w of one or more polyols, wherein the one or more polyols are selected from sugar alcohols and sugars.
Haemostatic kit with cross linked gelatine dry composition and aqueous medium
A haemostatic kit comprising a container comprising a dry composition comprising a frozen paste that has been freeze-dried, wherein the dry composition comprises cross linked gelatine and from about 10% w/w to about 60% w/w of one or more polyols selected from sugar alcohols and sugars, and a container comprising an aqueous medium, optionally an outer packaging.
Syringe or applicator with cross linked gelatine and polyols selected from sugar alcohols and sugars
A syringe or applicator comprising a dry composition comprising a frozen paste that has been freeze-dried, wherein the dry composition comprises cross linked gelatine and from about 10% w/w to about 60% w/w of one or more polyols, wherein the one or more polyols are selected from sugar alcohols and sugars.
Overall, the claim coverage is centered on a freeze-dried, reconstitutable dry haemostatic composition made from a frozen paste of a cross-linked biocompatible polymer and polyols selected from sugar alcohols and sugars, where reconstitution yields a substantially homogeneous paste without mechanical mixing. Delivery formats are covered as haemostatic kits and as syringe/applicator embodiments, with additional independent coverage specifying crosslinked gelatine as the biocompatible polymer.
Stated Advantages
Reduced preparation time and handling compared with conventional multi-step mixing/kit systems.
Improved sterility and consistency.
Ability to include unstable bioactives such as thrombin pre-drying.
Documented Applications
Use in haemostasis and wound healing as a dry composition that reconstitutes to a substantially homogeneous haemostatic paste.
Use in a haemostatic kit with a container containing the freeze-dried dry composition and a container containing an aqueous medium, optionally with outer packaging.
Use in a syringe or applicator for dispensing a reconstitutable haemostatic composition.
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