Dry haemostatic composition

Inventors

Larsen, Kristian

Assignees

Ferrosan Medical Devices AS

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Publication Number

US-10799611-B2

Patent

Publication Date

2020-10-13

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 provides a container comprising a dry composition comprising a frozen paste that has been freeze-dried. The dry composition comprises a biocompatible polymer and from about 10% w/w to about 60% w/w of one or more polyols.

Upon adding an aqueous medium to the container, the dry composition forms a paste. The freeze-dried paste reconstitutes into a substantially homogeneous haemostatic paste without mechanical mixing, thereby enabling direct use following reconstitution.

The formed paste is applied to a wound, bone, tendon and/or tissue in an individual in need thereof. The method thereby promotes haemostasis and/or wound, bone, tendon and/or tissue healing.

Claims Coverage

The independent claim provides a method covering haemostasis and/or wound, bone, tendon and/or tissue healing using a container holding a freeze-dried frozen paste that reconstitutes into a paste upon addition of an aqueous medium, followed by application to the target site. The main inventive features include the containerized dry composition, aqueous reconstitution, and application to promote haemostasis and/or healing, with dependent refinements including polyol content, rapid reconstitution, thrombin, specified growth factors and MMPs, and syringe container form.

Freeze-dried frozen paste composition in a container

Providing a container comprising a dry composition comprising a frozen paste that has been freeze-dried; the dry composition comprises a biocompatible polymer and from about 10% w/w to about 60% w/w of one or more polyols.

Aqueous medium addition to form a paste

Adding an aqueous medium to the container, thereby forming a paste.

Application of the formed paste to promote healing

Applying the paste to a wound, bone, tendon and/or tissue, thereby promoting haemostasis and/or wound, bone, tendon and/or tissue healing.

Substantially homogeneous haemostatic paste by rapid reconstitution

The dry composition reconstitutes within less than about 30 seconds to form a substantially homogeneous paste.

Syringe container format

The method further specifies that the container used is a syringe.

Thrombin in the dry composition

The dry composition includes thrombin.

Specified growth factors and MMPs in the dry composition

The dry composition includes one or more specified growth factors and matrix metalloproteinases (MMPs).

Overall claim coverage centers on a containerized freeze-dried biocompatible polymer/polyol dry composition that is reconstituted by adding an aqueous medium to form a paste and is applied to a wound, bone, tendon and/or tissue to promote haemostasis and/or healing, with dependent refinements including rapid formation of a substantially homogeneous paste, specific polyol content constraints, optional thrombin, specified growth factors/MMPs, and a syringe container.

Stated Advantages

Promotes haemostasis and/or wound, bone, tendon and/or tissue healing.

Documented Applications

Haemostasis and/or wound healing by applying the reconstituted paste to a wound.

Bone healing by applying the reconstituted paste to bone.

Tendon healing by applying the reconstituted paste to tendon.

Tissue healing by applying the reconstituted paste to tissue.

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