Method for preparing a haemostatic composition

Patent metadata

Field	Value
Publication number	US-11801324-B2
Application number	US-201916407503-A
Country	US
Kind code	B2
Filing date	May 9, 2019
Priority date	May 9, 2018
Publication date	Oct 31, 2023
Grant date	Oct 31, 2023

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.

First claim

The invention claimed is:

1. A method of preparing a haemostatic composition, the method comprising:
a) providing a dry thrombin composition in a first syringe;
b) providing a paste comprising a biocompatible polymer in a second syringe wherein the paste comprises the biocompatible polymer in a content of 7% w/w to 20% w/w;
c) connecting the first syringe and the second syringe using a suitable connector; and
d) mixing the contents of the syringes by transferring the contents between the syringes for 5 to 10 times, to produce a haemostatic composition having a homogenous distribution of thrombin and having a variation in thrombin content throughout the haemostatic composition of less than 20%.

2. The method according to claim 1 , wherein the homogenous distribution of thrombin is characterized by a variation in thrombin content throughout the haemostatic composition of less than 10%.

3. The method according to claim 1 , wherein the haemostatic composition is a paste suitable for use in haemostasis and/or wound healing.

4. The method according to claim 1 , wherein the haemostatic composition is a flowable composition.

5. The method according to claim 1 , wherein the dry thrombin composition is prepared by spray-drying or freeze-drying.

6. The method according to claim 1 , wherein the biocompatible polymer consists of powder particles which are substantially insoluble in an aqueous medium.

7. The method according to claim 1 , wherein the biocompatible polymer is cross-linked.

8. The method according to claim 1 , wherein the biocompatible polymer is gelatine, collagen, chitin, chitosan, alginate, cellulose, oxidised cellulose, polyglycolic acid, or polyacetic acid, or combinations thereof.

9. The method according to claim 1 , wherein the biocompatible polymer comprises or consists of gelatine.

10. The method according to claim 1 wherein the haemostatic composition comprises one or more hydrophilic compound(s).

11. The method according to claim 1 , wherein the haemostatic composition comprises one or more further bioactive agents capable of stimulating haemostasis, wound healing, bone healing, tissue healing and/or tendon healing.

12. The method according to claim 1 , wherein the haemostatic composition further comprises one or more extrusion enhancer(s).

13. The method according to claim 1 , wherein the first syringe is a glass syringe or wherein the first syringe comprises a glass insert comprising the dry thrombin composition.

14. A kit comprising:
a) a first syringe comprising a dry thrombin composition;
b) a second syringe comprising a paste comprising a biocompatible polymer, wherein the paste comprises the biocompatible polymer in a content of 7% w/w to 20% w/w;
c) optionally an outer package, and
d) instructions for using the kit for preparing a haemostatic composition wherein the two syringes are interconnectable to allow for transferring the contents between the syringes for 5 to 10 times, to produce a haemostatic composition having a homogenous distribution of thrombin and having a variation in thrombin content throughout the haemostatic composition of less than 20%.

15. A method for reconstituting a dry thrombin composition, the method comprising:
a) providing a dry thrombin composition in a first syringe;
b) providing a paste comprising a biocompatible polymer in a second syringe, wherein the paste comprises the biocompatible polymer in a content of 7% w/w to 20% w/w;
c) connecting the first syringe and the second syringe using a suitable connector; and
d) mixing the contents of the syringes by transferring the contents between the syringes for 5 to 10 times, to produce 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%.

16. The method according to claim 1 , wherein the number of transfers is between 6 and 10 times.

17. The method according to claim 1 , wherein the thrombin concentration in the haemostatic composition is in the range of 50 IU/mL to 1000 IU/mL.

18. A method of preparing a haemostatic composition, the method comprising:
a) providing a dry thrombin composition in a first syringe;
b) providing a gelatin paste in a second syringe, wherein the paste comprises gelatin in a content of 7% w/w to 20% w/w;
c) connecting the first syringe and the second syringe using a suitable connector; and
d) mixing the contents of the syringes by transferring the contents between the syringes for 5 to 10 times, to produce a haemostatic composition having a homogenous distribution of thrombin and having a variation in thrombin content throughout the haemostatic composition of less than 20%.

Assignees

• Ferrosan Medical Devices As
• Ethicon Inc

Inventors

• Hammershøj Peter Lund
• Larsen Kristian
• Johns Douglas B
• Smith Nicole
• Cardinale Michael
• Ferrara Gabriella
• Zhang Guanghui

Classifications

• A61L24/043 Primary

  Mixtures of macromolecular materials · CPC title

• A61B17/12186

  liquid materials adapted to be injected · CPC title

• A61L24/0042

  Materials resorbable by the body · CPC title

• A61B2017/00495

  for two-component glue · CPC title

• A61L2400/04

  Materials for stopping bleeding · CPC title