Process of making flowable hemostatic compositions and devices containing such compositions

a technology of compositions and hemostatic compositions, which is applied in the direction of aerosol delivery, bandages, other domestic articles, etc., can solve the problems of compromising the sterility of the delivered product, the need to mix powder and liquid, and time-consuming manipulations

Active Publication Date: 2010-09-16
ETHICON INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The solution provides a sterile, pre-filled hemostatic composition that is physically stable and easy to use, maintaining hemostatic properties and reducing preparation time, while minimizing the risk of sterility compromise and environmental contamination.

Problems solved by technology

The main disadvantage of this approach is the need to mix the powder with the liquid, knead it into a paste and back-fill it into the delivery device of choice, all at the time of need and at the point of use.
The manipulations are time consuming and potentially may compromise the sterility of the delivered product depending on the environment of use.

Method used

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  • Process of making flowable hemostatic compositions and devices containing such compositions
  • Process of making flowable hemostatic compositions and devices containing such compositions
  • Process of making flowable hemostatic compositions and devices containing such compositions

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0060] A total of ten samples were prepared as follows. One gram of dry Surgifoam® powder was placed in a plastic container and mixed with 4 ml of saline. The container was capped and the contents were shaken until a substantially homogenous paste of uniform consistency was obtained. The paste was formed into a cylindrical shape and placed into a 10 cc BD polypropylene disposable luer syringe. The syringes were then capped and five of the filled syringes were sterilized by gamma irradiation at a dose of 25 kGy. The Peak Expression Force was determined and presented in Table 1. Unsterilized samples are designated as 1a and sterilized samples are designated as 1b.

[0061] At total of 10 samples were prepared as follows. 1 gm of dry Surgifoam® powder was placed in a plastic container and mixed with 4 ml of saline. The container was capped and the contents were shaken until a substantially homogenous paste of uniform consistency was obtained. The paste was formed into a cylindrical shape...

example 2

[0062] A total of ten samples were prepared as follows. A saline solution containing 0.005% by weight of benzalkonium chloride and 5% weight of glycerol was prepared. This solution was used to prepare homogenous gelatin-powder pastes as described in Example 1. The paste was formed into a cylindrical shape and placed into a 10 cc BD polypropylene disposable luer syringe. The syringes were then capped and five of the filled syringes were sterilized by irradiation at a dose of 25kGy. The Peak Expression Force was determined and presented in Table 1. Unsterilized samples are designated as 2a and sterilized samples are designated as 2b.

[0063] A total of ten samples were prepared as follows. A saline solution containing 0.005% by weight of benzalkonium chloride and 5% by weight of glycerol was prepared. This solution was used to prepare homogenous gelatin-powder pastes as described in Example 1. A second 10 cc BD luer syringe containing 3 ml of nitrogen then was connected to the syringe ...

example 3

[0065] 25 grams of Surgifoam® gelatin powder were mixed with 125 ml of normal saline containing 0.005% benzalkonium chloride and 5% glycerol, based on weight of saline, until a uniform paste was formed. The resulting paste was loaded into a ½ pint Donvier mixer fitted with a mixing paddle. A tube connected to a nitrogen source was fitted through the lid of the mixer and the system “closed” to the environment by wrapping in a film. The system was purged with nitrogen for 20 minutes. The paste was then mixed to homogenously incorporate the nitrogen by rotating the paddle rapidly by hand. Mixing was terminated when the composition filled the available volume, indicating homogeneous distribution of the gas phase. The composition was loaded into a 60 cc syringe and subsequently dispensed into 10 cc BD luer syringes via a two-way luer connector. The density of the composition was approximately 0.7-0.75 grams / ml. The syringes were then capped and some of the filled syringes were sterilized...

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Abstract

The present invention is directed to processes of making flowable hemostatic compositions and devices that include the flowable hemostatic composition disposed therein, where a volume of a biocompatible liquid, a volume of a biocompatible gas, and an amount of solid particles of a biocompatible polymer are mixed together to form a substantially homogenous composition including a discontinuous gas phase and the solid particles substantially homogenously dispersed throughout a continuous liquid phase to form a flowable hemostatic composition, and the composition then transferred into a device suitable for applying the flowable hemostatic composition to a site of a body requiring hemostasis under conditions effective to maintain the substantially homogeneous dispersion of the gas phase and the solid particles throughout the liquid phase, wherein said transfer of said substantially homogenous hemostatic composition is conducted at an angle.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] The subject matter of this application is related to U.S. application Ser. No. 10 / 896647 filed Jul. 22, 2004, U.S. application Ser. No. 10 / 896454 filed Jul. 22, 2004, U.S. application Ser. No. 10 / 768335 filed Jan. 30, 2004 and U.S. Provisional Application Ser. No. 60 / 493116 filed Aug. 7, 2003.FIELD OF THE INVENTION [0002] The present invention relates to methods of making flowable hemostatic compositions and devices containing such compositions. BACKGROUND OF THE INVENTION [0003] Gelatin-based hemostats, both in solid sponge or powder form, are commercially available and are used in surgical procedures. Gelatin powder, when mixed with fluid, can form a paste or slurry that is useful as a flowable, extrudable and injectable hemostat for diffuse bleeding, particularly from uneven surfaces or hard to reach areas. The conventional slurry is prepared at the point of use by mechanical agitation and mixing of the powder and liquid to provide u...

Claims

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Application Information

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Patent Type & AuthorityApplications(United States)
IPC IPC(8): B27N3/00A61K9/70
CPCA61K9/12A61K9/0019
InventorGABEL, JONATHAN B.LOONEY, DWAYNE L.GUGLIELMO, MICHAEL E.
OwnerETHICON INC