WO2004010913A1 - Bandages de fibrinogènes et procédés - Google Patents

Bandages de fibrinogènes et procédés Download PDF

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Publication number
WO2004010913A1
WO2004010913A1 PCT/US2002/023607 US0223607W WO2004010913A1 WO 2004010913 A1 WO2004010913 A1 WO 2004010913A1 US 0223607 W US0223607 W US 0223607W WO 2004010913 A1 WO2004010913 A1 WO 2004010913A1
Authority
WO
WIPO (PCT)
Prior art keywords
fibrinogen
bandage
procoagulant
wound dressing
wound
Prior art date
Application number
PCT/US2002/023607
Other languages
English (en)
Inventor
Stephen W Rothwell
Chitra Krishnamurti
Thomas J. Reid, Iii
Original Assignee
Us Army Medical Research & Materiel Command
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Us Army Medical Research & Materiel Command filed Critical Us Army Medical Research & Materiel Command
Priority to PCT/US2002/023607 priority Critical patent/WO2004010913A1/fr
Priority to AU2002316755A priority patent/AU2002316755A1/en
Priority claimed from US10/202,650 external-priority patent/US6891077B2/en
Publication of WO2004010913A1 publication Critical patent/WO2004010913A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/22—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing macromolecular materials
    • A61L15/32—Proteins, polypeptides; Degradation products or derivatives thereof, e.g. albumin, collagen, fibrin, gelatin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00646—Type of implements
    • A61B2017/00659—Type of implements located only on one side of the opening
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2400/00—Materials characterised by their function or physical properties
    • A61L2400/04—Materials for stopping bleeding

Definitions

  • the present invention provides a method of increasing blood platelet counts in a subject comprising administering to the subject fibrinogen, fibrin, or both and at least one procoagulant.
  • Figure 7 is a graph comparing the number of compressions required to stop the bleeding following puncture of the femoral artery and application of each of the two bandages. Values are as compressions and show the mean ⁇ SEM. Number of animals
  • Procoagulants also include platelet-activating factors, such as thrombin, epinephrine, adenosine diphosphate, calcium, thromboxane, and the like, and cellular components, such as collagen, fibronectin, and the like.
  • platelet-activating factors such as thrombin, epinephrine, adenosine diphosphate, calcium, thromboxane, and the like
  • cellular components such as collagen, fibronectin, and the like.
  • the procoagulant, propyl gallate was used in the form of HemostatinTM, which is available from Analytical Control Systems, h e. (Fishers, LN).
  • the fibrinogen bandages of the present invention comprise a procoagulant in a therapeutic amount.
  • a "therapeutic amount" of a procoagulant is an amount that promotes blood coagulation, clot formation, or both.
  • a "therapeutic amount” of propyl gallate ranges from about 100 ⁇ g/cm 2 to about 3,000 ⁇ g/cm 2 , preferably about 250 ⁇ g/cm 2 to about 2,000 ⁇ g/cm 2 , more preferably about 500 ⁇ g/cm to about 1,000 mg/cm of the surface area of a wound.
  • One of ordinary skill in the art may readily determine the optimal therapeutic amount of a given procoagulant with routine methods in the art.
  • fibrinogen bandages comprising propyl gallate to promote coagulation and scab formation was compared to fibrinogen bandages without propyl gallate in the arterial bleeding model described in the Examples below.
  • Propyl gallate is commonly used in amounts that make it suitable as an emulsifier, preservative or antioxidant in pharmaceutical formulations. As an antioxidant, propyl gallate interferes with two critical oxygenase enzymes that produce stimulatory molecules in platelets, and thereby dampen the platelet response during clotting.
  • the artery wall was scored first with the punch and then the tissue was removed with scissors. This resulted in a well-defined hole with clear-cut edges.
  • the bandage preparation having the propyl gallate in the pouch sewn on the fibrinogen bandage was used.
  • the blood loss from this injury was slightly higher than the first trial and this higher loss began to accentuate differences between the bandage treatments.
  • the present invention provides fibrinogen bandages comprising a procoagulant such as propyl gallate (PG).
  • PG propyl gallate
  • a fibrinogen bandage comprising a procoagulant may provide substantially the same result as a bandage using a greater amount of fibrinogen only.
  • the present invention also provides methods of treating a wound comprising apply to the wound a fibrinogen bandage comprising a procoagulant.
  • the fibrinogen bandages of the present invention are useful in the treatment of wounds, hemorrhages, burns and the like.
  • wounds include those caused by lacerations, punctures, and surgery, such as those resulting from motorcycle accidents, and deep thoracic surgery.
  • the fibrinogen bandages of the present invention are useful for treating wounds having a large surface area and wounds that are difficult to suture or cauterize.
  • the fibrinogen bandages are also useful for promoting healing of tissue grafts and burns.
  • Pulse oximetry, EtCO 2 , EKG/BP and temperature (rectal) were monitored throughout the surgery.
  • An arterial catheter was placed for blood pressure monitoring and for collection of arterial blood for blood gases and for coagulation tests.
  • a venous catheter was placed for administration of resuscitation fluids.
  • the femoral artery was isolated and umbilical ties were placed proximal and distal to the arteriotomy site for vessel orientation. Bull dog clamps were placed proximal and distal to the arteriotomy site to control for bleeding. A 2 mm diameter skin biopsy punch was used to make a reproducible injury. See Figure 3 for schematic and Figure 4 of an arteriotomy preparation.
  • the punch was used only to score the arterial wall to mark a template, his scissors were then used to create the actual hole. This approach eliminated the uncertainty of holes with hanging tissue or penetration through the full thickness of the artery.
  • Hemorrhage parameters are expressed as means ⁇ SEM.
  • Platelet counts and aPPT are shown as percent initial value (tend / to x 100). Fibrinogen is shown as the concentration at the time bleeding stopped. P values for fibrinogen were not significant (NS) when calculated within groups (initial vs. final concentration) or between experimental (Fibrinogen vs PG/fibrinogen).

Abstract

La présente invention a trait à des bandages comportant un constituant fibrinogène et au moins un agent procoagulant tel que le gallate de propyle en une quantité thérapeutique. L'invention a également trait à des procédés de traitement de plaies, conduisant à l'augmentation d'une quantité ou du taux de coagulation sanguine dans une plaie, l'augmentation d'une quantité ou du taux de formation de caillots sur une plaie, l'augmentation du nombre de plaquettes, l'activation du système de coagulation, l'augmentation de la concentration plasmatique de fibrinogène, et la réduction partielle de la durée d'activation de thromboplastine. L'invention a également trait à un modèle de saignement artériel et des procédés d'observation de saignement artériel.
PCT/US2002/023607 2001-07-25 2002-07-25 Bandages de fibrinogènes et procédés WO2004010913A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
PCT/US2002/023607 WO2004010913A1 (fr) 2001-07-25 2002-07-25 Bandages de fibrinogènes et procédés
AU2002316755A AU2002316755A1 (en) 2001-07-25 2002-07-25 Fibrinogen bandages and methods

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US30735501P 2001-07-25 2001-07-25
US10/202,650 US6891077B2 (en) 2001-07-25 2002-07-25 Fibrinogen bandages and arterial bleeding models and methods of making and using thereof
PCT/US2002/023607 WO2004010913A1 (fr) 2001-07-25 2002-07-25 Bandages de fibrinogènes et procédés

Publications (1)

Publication Number Publication Date
WO2004010913A1 true WO2004010913A1 (fr) 2004-02-05

Family

ID=32329690

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2002/023607 WO2004010913A1 (fr) 2001-07-25 2002-07-25 Bandages de fibrinogènes et procédés

Country Status (1)

Country Link
WO (1) WO2004010913A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2056756A2 (fr) * 2006-08-04 2009-05-13 Stb Lifesaving Technologies, Inc. Pansement solide pour le traitement de lésion tissulaire
US10772767B2 (en) 2013-06-28 2020-09-15 3M Innovative Properties Company Fibrin-coated wound dressing

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4453939A (en) * 1981-02-16 1984-06-12 Hormon-Chemie Munchen Gmbh Composition for sealing and healing wounds
US4973466A (en) * 1988-06-21 1990-11-27 Chiron Ophthalmics, Inc. Wound-healing dressings and methods
US5202118A (en) * 1987-12-18 1993-04-13 Immunex Corporation Method for promoting wound healing using IL-1

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4453939A (en) * 1981-02-16 1984-06-12 Hormon-Chemie Munchen Gmbh Composition for sealing and healing wounds
US5202118A (en) * 1987-12-18 1993-04-13 Immunex Corporation Method for promoting wound healing using IL-1
US4973466A (en) * 1988-06-21 1990-11-27 Chiron Ophthalmics, Inc. Wound-healing dressings and methods

Cited By (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2056756A2 (fr) * 2006-08-04 2009-05-13 Stb Lifesaving Technologies, Inc. Pansement solide pour le traitement de lésion tissulaire
EP2059205A2 (fr) * 2006-08-04 2009-05-20 Stb Lifesaving Technologies, Inc. Procédé de production de pansement solide pour le traitement de lésion tissulaire
EP2063831A2 (fr) * 2006-08-04 2009-06-03 Stb Lifesaving Technologies, Inc. Pansement solide pour le traitement de lésion tissulaire
EP2063832A2 (fr) * 2006-08-04 2009-06-03 Stb Lifesaving Technologies, Inc. Pansement solide pour le traitement de lésion tissulaire
JP2009545424A (ja) * 2006-08-04 2009-12-24 エスティービー ライフセービング テクノロジーズ インコーポレイテッド 創傷組織を治療するための固体包帯材
JP2009545423A (ja) * 2006-08-04 2009-12-24 エスティービー ライフセービング テクノロジーズ インコーポレイテッド 創傷組織を治療するための固体包帯材
JP2009545422A (ja) * 2006-08-04 2009-12-24 エスティービー ライフセービング テクノロジーズ インコーポレイテッド 創傷組織を治療するための固体包帯材
JP2009545421A (ja) * 2006-08-04 2009-12-24 エスティービー ライフセービング テクノロジーズ インコーポレイテッド 創傷組織を治療するための固体包帯材の製造方法
EP2063831A4 (fr) * 2006-08-04 2010-10-06 Stb Lifesaving Technologies In Pansement solide pour le traitement de lésion tissulaire
EP2063832A4 (fr) * 2006-08-04 2010-10-06 Stb Lifesaving Technologies In Pansement solide pour le traitement de lésion tissulaire
EP2059205A4 (fr) * 2006-08-04 2010-10-06 Stb Lifesaving Technologies In Procédé de production de pansement solide pour le traitement de lésion tissulaire
EP2056756A4 (fr) * 2006-08-04 2010-10-06 Stb Lifesaving Technologies In Pansement solide pour le traitement de lésion tissulaire
US8445009B2 (en) 2006-08-04 2013-05-21 Stb, Ltd Processes for the production of solid dressings for treating wounded tissue
AU2007281996B2 (en) * 2006-08-04 2013-06-27 Stb, Ltd Solid dressing for treating wounded tissue
JP2014023956A (ja) * 2006-08-04 2014-02-06 Stb Ltd 創傷組織を治療するための固体包帯材
JP2014073424A (ja) * 2006-08-04 2014-04-24 Stb Ltd 創傷組織を治療するための固体包帯材
JP2014148541A (ja) * 2006-08-04 2014-08-21 Stb Ltd 創傷組織を治療するための固体包帯材の製造方法
US10772767B2 (en) 2013-06-28 2020-09-15 3M Innovative Properties Company Fibrin-coated wound dressing

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