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Solid dressing for treating wounded tissue

a wound tissue and dressing technology, applied in the direction of drug compositions, extracellular fluid disorders, peptide/protein ingredients, etc., can solve the problems of unsatisfactory bleeding stopper materials and methods available in pre-hospital care (gauze dressings, direct pressure, tourniquets), occurrence of excessive bleeding or fatal hemorrhage from an accessible site, and unsatisfactory effects in the past 2000 years

Inactive Publication Date: 2008-02-07
STB LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The materials and methods available to stop bleeding in pre-hospital care (gauze dressings, direct pressure, and tourniquets) have, unfortunately, not changed significantly in the past 2000 years.
Even in trained hands they are not uniformly effective, and the occurrence of excessive bleeding or fatal hemorrhage from an accessible site is not uncommon.
The particles appear to exert their haemostatic effect by absorbing water from the blood and plasma in the wound, resulting in the accumulation and concentration of clotting factors and platelets.
In two studies of a lethal groin wound model, however, this agent showed no meaningful benefit over standard gauze dressings.
Although this agent has been used successfully in some animal studies, there remains concern about the exothermic process of fluid absorption by the particles.
This bandage has shown improved hemostasis and reduced blood loss in several animal models of arterial hemorrhage, but a marked variability was observed between bandages, including the failure of some due to inadequate adherence to the wound.
As liquids, however, these fibrin sealants have not proved useful for treating traumatic injuries in the field.
While these fibrinogen-thrombin dressings do not require the pre-mixing needed by liquid fibrin sealants, their utility for field applications is limited by a requirement for storage at 4° C. and the necessity for pre-wetting with saline solution prior to application to the wound.
These dressings are also not effective against high pressure, high volume bleeding.
While this dressing has shown great success in several animal models of hemorrhage, the bandage is fragile, inflexible, and has a tendency to break apart when handled.
To date, none of these dressings have been approved for use or are available commercially.

Method used

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  • Solid dressing for treating wounded tissue
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  • Solid dressing for treating wounded tissue

Examples

Experimental program
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Effect test

example 1

[0103] Backing material (DEXON™) was placed into 2.4×2.4 cm PETG molds. Twenty-five microliters of 2% sucrose was pipetted on top of each of the four corners of the backing material. Once completed the molds were placed in a −80° C. freezer for at least 60 minutes.

[0104] Fibrinogen (Enzyme Research Laboratories™ (ERL) lot 3114) was formulated in 100 mM Sodium Chloride, 1.1 mM Calcium Chloride, 10 mM Tris, 10 mM Sodium Citrate, 1.5% Sucrose, Human Serum Albumin (HSA) at a concentration of 80 mg / g of total protein and 15 mg / g total protein of Tween™ 80 (animal source) (Complete Fibrinogen buffer (CFB)). The fibrinogen concentration was adjusted to 37.5 mg / ml using CFB. The final pH of the fibrinogen was 7.4±0.1. Once prepared the fibrinogen was placed on ice until use.

[0105] Thrombin was formulated in 150 mM Sodium Chloride, 40 mM Calcium Chloride, 10 mM Tris and 100 mM L-Lysine with the addition of HSA at 100 ug / ml (Complete Thrombin Buffer (CTB)). The final pH of the thrombin was ...

example 2

[0107] Backing material was placed into each 1.5×1.5 cm PVC molds. Fifteen microliters of 2% sucrose was pipetted on top of each of the four corners of the backing material. A second piece of PETG plastic was fitted on top of the 1.5×1.5 molds and held in place. This formed a closed mold. The molds were then placed in a −80° C. freezer for at least 60 minutes. Fibrinogen (ERL lot 3100) was formulated in CFB. The fibrinogen concentration was adjusted to 37.5 mg / ml using CFB. The final pH of the fibrinogen was 7.4±0.1. Once prepared the fibrinogen was placed on ice until use. Thrombin was formulated in CTB. The final pH of the thrombin was 7.4±0.1. The thrombin concentrations were adjusted using CTB to deliver the following amounts 2.5, 0.25, 0.1, 0.05, 0.025, 0.016, 0.0125 and 0.01 units / mg of Fibrinogen (upon mixing), which corresponded to 624, 62.4, 25, 12.5, 6.24, 3.99, 3.12, and 2.5 Units / ml thrombin prior to mixing. Once prepared the thrombin was placed on ice until use. The tem...

example 3

[0108] Backing material was placed into 2.4×2.4 cm PVC molds. Twenty-five microliters of 2% sucrose was pipetted on top of each of the four corners of the backing material. Once completed the molds were placed in a −80° C. freezer for at least 60 minutes. Fibrinogen (ERL lot 3100) was formulated in CFB. The fibrinogen concentration was adjusted to 37.5 mg / ml using CFB. The final pH of the fibrinogen was 7.4±0.1. Once prepared the fibrinogen was placed on ice until use. Thrombin was formulated in CTB. The final pH of the thrombin was 7.4±0.1. Using CTB, the thrombin concentrations were adjusted to deliver the following amounts 0.125, 0.025, 0.0125, 0.00625 and 0.0031 units / mg of Fibrinogen upon mixing, which corresponded to 31.2, 6.24, 3.12, 1.56 and 0.78 Units / ml thrombin prior to mixing. Once prepared the thrombin was placed on ice until use. The temperature of the fibrinogen and thrombin prior to dispensing was 4° C.±2° C. The molds were removed from the −80° C. freezer and placed...

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Abstract

Disclosed are solid dressings for treated wounded tissue in mammalian patients, such as a human, comprising a haemostatic layer consisting essentially of a fibrinogen component and thrombin, wherein the thrombin is present in an amount between 0.250 Units / mg of fibrinogen component and 0.062 Units / mg of fibrinogen component. Also disclosed are methods for treating wounded tissue.

Description

FIELD OF THE INVENTION [0001] The present invention relates to a solid dressing for treating wounded tissue in a mammalian patient, such as a human. BACKGROUND OF THE INVENTION [0002] The materials and methods available to stop bleeding in pre-hospital care (gauze dressings, direct pressure, and tourniquets) have, unfortunately, not changed significantly in the past 2000 years. See L. Zimmerman et al., Great Ideas in the History of Surgery (San Francisco, Calif.: Norman Publishing; 1993), 31. Even in trained hands they are not uniformly effective, and the occurrence of excessive bleeding or fatal hemorrhage from an accessible site is not uncommon. See J. M. Rocko et al., J. Trauma 22:635 (1982). [0003] Mortality data from Vietnam indicates that 10% of combat deaths were due to uncontrolled extremity hemorrhage. See SAS / STAT Users Guide, 4th ed. (Cary, N.C.: SAS Institute Inc; 1990). Up to one third of the deaths from ex-sanguination during the Vietnam War could have been prevented b...

Claims

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Application Information

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IPC IPC(8): A61F13/00
CPCA61F13/00012A61F13/00017A61L26/0052A61L26/0042A61L15/32A61F13/00021A61F13/00034A61F13/00063A61F13/00068A61F13/00991A61F2013/00106A61F2013/00174A61F2013/00472A61F2013/00536A61F2013/0054A61F2013/0091A61F2013/00931A61L15/225C08L89/00A61F13/0226A61F13/0246A61L2400/04A61K38/363A61K38/4833C12Y304/21005A61P17/02A61P7/04A61F13/01017A61F13/01021A61F13/01034A61F13/01012A61F13/05A61F13/01029A61L26/0066A61L26/009A61L2300/252A61L2300/254A61L2300/418A61F13/02A61L15/44A61L15/64A61L15/38A61L15/58A61L15/18A61L15/26A61L15/28A61L15/325A61L2300/10A61L2300/604A61L2300/606A61L2300/608
Inventor MACPHEE, MARTINBEALL, DAWSON
Owner STB LTD
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