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Publication Number
US-9265858-B2
Publication Date
2016-02-23
Expiration Date
Abstract
Disclosed is 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. Further disclosed are 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 dry composition includes a cross-linked biocompatible polymer in powder form and one or more polyols selected from sugar alcohols and sugars, and is produced so that, upon addition of an aqueous medium, it is capable of reconstituting to form a substantially homogeneous paste without mechanical mixing.
The preparation involves providing the cross-linked biocompatible polymer in powder form, the one or more polyols, and an aqueous medium, then mixing to obtain a paste. The paste is freeze-dried to produce the dry composition, which comprises from 10% w/w to 60% w/w of one or more polyols, and the reconstituted paste forms without the need for mechanical mixing.
A reconstitution method is also described, where the dry composition prepared by freeze-drying is combined with an aqueous medium to form a paste without mechanical mixing. In the dry composition, the cross-linked biocompatible polymer and the one or more polyols selected from sugar alcohols and sugars are present, and the aqueous medium is added to achieve a substantially homogeneous paste.
Claims Coverage
The document contains two independent claims covering a method of preparing a dry haemostasis and wound-healing composition and a method of reconstituting that dry composition into a substantially homogeneous paste without mechanical mixing. The inventive features include freeze-drying of a paste formed from a cross-linked biocompatible polymer, one or more polyols selected from sugar alcohols and sugars, an aqueous medium, and a defined polyol content range.
Freeze-drying to form a dry composition reconstitutable without mechanical mixing
A method of preparing a dry composition suitable for use in haemostasis and wound healing, comprising providing a cross-linked biocompatible polymer in powder form, one or more polyols selected from sugar alcohols and sugars, and an aqueous medium, mixing to obtain a paste, and freeze-drying the paste to produce a dry composition that reconstitutes to form a substantially homogeneous paste without mechanical mixing.
Polyol content of 10% w/w to 60% w/w
The dry composition comprises from 10% w/w to 60% w/w of one or more polyols selected from sugar alcohols and sugars.
Reconstitution by adding aqueous medium without mechanical mixing
A method for reconstituting a dry composition suitable for use in haemostasis and wound healing, comprising providing a cross-linked biocompatible polymer in powder form, one or more polyols selected from sugar alcohols and sugars, and an aqueous medium, mixing to obtain a paste, freeze-drying the paste to produce a dry composition that reconstitutes to form a substantially homogeneous paste without mechanical mixing, and adding an aqueous medium to the dry composition thereby forming a paste without the need for mechanical mixing.
Overall claim coverage centers on producing and using a freeze-dried haemostatic and wound-healing dry composition that contains 10% w/w to 60% w/w polyols and reconstitutes into a substantially homogeneous paste without mechanical mixing upon aqueous addition.
Stated Advantages
Reduced preparation time.
Improved sterility/consistency.
Maintaining thrombin activity.
Documented Applications
Use in haemostasis and wound healing.
A haemostatic kit or medical/surgical use in connection with a dry haemostatic composition capable of being reconstituted into a paste without mechanical mixing.
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