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Clay-based hemostatic agents and devices for the delivery thereof

a technology of hemostasis and hemostasis agent, which is applied in the direction of antibacterial agents, drug compositions, extracellular fluid disorder, etc., can solve the problems of insufficient immediate availability of equipment and trained personnel, insufficient stanch blood flow, and insufficient hemostasis promoting effect, so as to facilitate the use of components, reduce discomfort and/or further injury to patients, and eliminate heat generation

Inactive Publication Date: 2009-07-23
TELEFLEX LIFE SCI LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

"The present invention relates to devices and methods for promoting blood clotting to control bleeding. The invention includes a clay material in particle form or retained in a receptacle with openings, a gauze substrate with openings, or a bandage with a mesh and clay material. The clay material comes into contact with blood through the openings, causing the hemostatic effect. The invention also includes a hemostatic sponge and other forms of hemostatic devices. The advantage of the invention is that the clay material does not generate heat and can be used in a variety of devices and on different surfaces. The invention is easy to apply to open wounds and can be readily removed from sterilized packaging and placed at the points from which blood emanates to cause clotting."

Problems solved by technology

Often bleeding is associated with such wounds.
Unfortunately, however, in other circumstances substantial bleeding can occur.
If such aid is not readily available, excessive blood loss can occur.
When bleeding is severe, sometimes the immediate availability of equipment and trained personnel is still insufficient to stanch the flow of blood in a timely manner.
Moreover, severe wounds can often be inflicted in remote areas or in situations, such as on a battlefield, where adequate medical assistance is not immediately available.
Although these materials have been shown to be somewhat successful, they are sometimes not effective enough for traumatic wounds and tend to be expensive.
Furthermore, these materials are sometimes ineffective in some situations and can be difficult to apply as well as remove from a wound.
Additionally, or alternatively, the previously developed materials can produce undesirable side effects.
Oftentimes excess material is unnecessarily poured onto a wound, which can exacerbate the exothermic effects.
Depending upon the specific attributes of the material, the resulting exothermia may be sufficient to cause discomfort to or even burn the patient.
Although some prior art patents specifically recite the resulting exothermia as being a desirable feature that can provide clotting effects to the wound that are similar to cauterization, there exists the possibility that the tissue at and around the wound site may be undesirably impacted.
If an amount of material is administered that causes discomfort or burning, the wound may require immediate flushing.
In instances where a wounded person or animal has not yet been transported to a facility capable of providing the needed irrigation, undesirable effects or over-treatment of the wound may result.
Bleeding can also be a problem during surgical procedures.
However, when the bleeding becomes excessive, these measures may not be sufficient to stop the blood flow.
Moreover, any highly exothermic bleed-control material may damage the tissue surrounding the bleed site and may not be configured for easy removal after use.

Method used

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  • Clay-based hemostatic agents and devices for the delivery thereof
  • Clay-based hemostatic agents and devices for the delivery thereof
  • Clay-based hemostatic agents and devices for the delivery thereof

Examples

Experimental program
Comparison scheme
Effect test

example 1

The Effect of Slurry Temperature on the Ability of Cotton Gauze to Retain Kaolin Clay

[0073]Temperatures of kaolin / water slurries were varied to assess the ability of cotton gauze to retain kaolin clay. Slurries of water and EPK were prepared in which the kaolin was 40% of the total weight of the slurry. Three sponges were made (one from each piece of gauze) by immersing the cotton gauzes into the slurries of varying temperatures, rolling the wet sponges under pressure, and drying. The Table below indicates the parameters for each slurry and the results obtained.

Slurry Temp.AgitationStarting Gauzegauze weight% kaolinSample(degrees C.)methodweight (grams)after (grams)(wt. %)122Stir 13.1395.5944minute290Stir 13.0645.86848minute3100Boil 13.0856.48152minute

[0074]The gauze weight after is the weight of the gauze after rolling and drying. It was noted that the elevated slurry temperature increased the amount of retained kaolin. One theory for this is that the cotton fiber structure of the ...

example 2

Application of Dry Kaolin to Dry Cotton Gauze to Form Hemostatic Device

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Abstract

A device for promoting the clotting of blood comprises a clay material in particle form and a receptacle for containing the clay material. At least a portion of the receptacle is defined by a mesh. Another device comprises a gauze substrate and a clay material disposed on the gauze substrate. Another device is a bandage comprising a substrate, a mesh mounted on the substrate, and particles of a clay material retained in the mesh. A hemostatic sponge comprises a substrate, a hemostatic material disposed on a first surface of the substrate, and a release agent disposed on a second surface of the substrate. The release agent is disposed on the wound-contacting surface of the substrate. When treating a bleeding wound, application of the hemostatic sponge causes at least a portion of the hemostatic material to come into contact with blood through the release agent and through the substrate.

Description

CROSS REFERENCE TO RELATED APPLICATIONS[0001]This application is a continuation of U.S. patent application Ser. No. 11 / 590,427, filed Oct. 30, 2006, which claims priority to U.S. Provisional Patent Application Ser. No. 60 / 808,618, filed May 26, 2006, entitled “Blood Clotting Compound” and U.S. Provisional Patent Application Ser. No. 60 / 810,447, filed Jun. 1, 2006, entitled “Hemostatic Device with Oxidized Cellulose Pad”; the contents of all of the above-referenced applications being incorporated herein by reference in their entireties.TECHNICAL FIELD[0002]The present invention relates generally to agents and devices for promoting hemostasis and, more particularly, to clay-based hemostatic agents and devices incorporating such agents for the delivery thereof to bleeding wounds.BACKGROUND OF THE INVENTION[0003]Blood is a liquid tissue that includes red cells, white cells, corpuscles, and platelets dispersed in a liquid phase. The liquid phase is plasma, which includes acids, lipids, s...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K9/70A61K33/34A61K33/38A61P17/02
CPCA61L15/18A61L15/44A61L2300/102A61L2300/402A61F13/534A61L2300/41A61L2300/418A61L2400/04A61L2300/404A61P17/02A61P29/00A61P31/00A61P31/04A61P31/10A61P7/04
Inventor HUEY, RAYMONDLO, DENNYBURNS, DANIEL J.
Owner TELEFLEX LIFE SCI LTD
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