Nova Patents
EP1547626A2

Carrier with solid fibrinogen and solid thrombin

Abstract

The present invention relates to a solid composition useful for tissue gluing, tissue sealing and haemostasis consisting essentially of a) a carrier which has at least one of the following physical properties: elasticity module in the range of 5-100 N/cm, density of 1-10 mg/cm3, chamber diameter of more than 0.75 mm and less than 4 mm and/or having a chamber diameter average below 3 mm and evenly distributed and fixed upon said carrier, b) solid fibrinogen, and c) solid thrombin. The carrier is a biodegradable polymer such as a polyhyaluronic acid, polyhydroxy acid, e.g. lactic acid, glucolic acid, hydroxybutanoic acid, a cellulose, gelatine or collagen, such as a collagen sponge, e.g. a collagen sponge consisting essentially of collagen type I fibres. The fibrinogen and thrombin are preferably human, purified from a natural source, or transgenic or recombinant human fibrinogen and/or thrombin. In a preferred embodiment the composition does not comprise any antifibronolytic agent such as aprotinin, ε-aminocaproic acid or α2-antiplasmin,

EP1547626A2, drawing sheet 1
Sheet 1 of 12

Term

Term ended

Projected expiry passed 25 January 2022, 4.7 years ago.

  1. Priority
  2. Filed
  3. Published
  4. Projected expiry
  5. Today

23 claims: 21 independent, 2 dependent

  1. 1
    A solid composition consisting essentially of a) a carrier which has at least one of the following physical properties:elasticity module in the range of 5-100 N/cm,density of 1-10 mg/cm3,chamber diameter of more than 0.75 mm and less than 4 mm and/or having a chamber diameter average below 3 mm and evenly distributed and fixed upon said carrierb) solid fibrinogen, andc) solid thrombin.
  2. 4
    A composition according to any of claims 1-3 wherein the carrier has one or more active sides wherein fibrinogen is present in an amount of 2-10 mg//cm2, such as 4.3-6.7 mg/cm2, preferably about 5.5 mg/cm2, and thrombin is present in an amount of 1.5-5.5 IU/cm2, preferably about 2.0 IU/cm2.
  3. 5
    A composition according to any of claims 1-4 wherein the fibrinogen is human, purified from a natural source, or transgenic or recombinant human fibrinogen.
  4. 6
    A composition according to any of claims 1-5 wherein the fibrinogen is purified from a natural source.
  5. 7
    A composition according to any of claims 1-5 wherein the fibrinogen is transgenic or recombinant.
  6. 8
    A composition according to any of claims 1-7 wherein the thrombin is human, purified from a natural source, or transgenic or recombinant human thrombin.
  7. 9
    A composition according to any of claims 1-8 wherein the thrombin is purified from a natural source.
  8. 10
    A composition according to any of claims 1-8 wherein the thrombin is transgenic or recombinant.
  9. 11
    A material for haemostasis, tissue sealing and tissue gluing which contains a flexible carrier which has at least one of the following physical properties:elasticity module in the range of 5-100 N/cm,density of 1-10 mg/cm3,chamber diameter of more than 0.75 mm and less than 4 mm and/or having a chamber diameter average below 3 mm and which further comprisessolid fibrinogenand solid thrombinand does not comprise any antifibronolytic agent such as aprotinin, ε-aminocaproic acid or α2-antiplasmin, the solid fibrinogen and solid thrombin being fixed to the carrier in a manner so that the abrasion is less than 1.0 mg/cm2 when a sample of the coated material is shaken on a Vibrofix shaker at a frequence of about 1000 rpm for 2 minutes and if the coated carrier material is inserted into an endoscopic equipment and thereafter removed, the material is substantially unchanged and has a cast of coating material less than 20% as an indication of the flexibility of the carrier and the solid adhesion of the solid fibrinogen and solid thrombin said material being substantially air tight and liquid tight and having an elasticity factor of at least 1.25 as determined by a test comprising fixation of the coated carrier to a Latex sheet, expansion of the Latex by pressure three times and at the third time measuring the area of the coated carrier at the highest point of Latex sheet expansion and comparing the expanded area of the coated carrier with the starting area of the coated area.
  10. 12
    Use of a carrier having at least one of the following physical properties:an elasticity module in the range of 5-100 N/cm,a density of 1-10 mg/cm3,chamber diameter of more than 0.75 mm and less than 4 mm and/or having a chamber diameter average below 3 mm and a sufficient amount of fibrinogen and a sufficient amount of thrombin for the preparation of a product for tissue sealing.
  11. 13
    Use of a carrier having at least one of the following physical properties:an elasticity module in the range of 5-100 N/cm,a density of 1-10 mg/cm3,chamber diameter of more than 0.75 mm and less than 4 mm and/or having a chamber diameter average below 3 mm and a sufficient amount of fibrinogen and a sufficient amount of thrombin for the preparation of a product for haemostasis.
  12. 14
    Use of a carrier having at least one of the following physical properties:an elasticity module in the range of 5-100 N/cm,a density of 1-10 mg/cm3,chamber diameter of more than 0.75 mm and less than 4 mm and/or having a chamber diameter average below 3 mm and a sufficient amount of fibrinogen and a sufficient amount of thrombin for the preparation of a product for tissue sealing.
  13. 15
    Use according to any of claims 12-14 for surgical interventions in the gastrointestinal system, such as the oesophagus, stomach, small intestine, large intestine, rectum, on parenchymal organs, such as liver, spleen, pancreas, kidneys, lungs, adrenal glands, thyroid and lymph nodes, cardiovascular surgery, thoracic surgery including surgery on the trachea, bronchi and lungs, surgical interventions in the ear, nose and throat (ENT) area including dental surgery, gynaecological, urological, vascular, bone (e.g. spongiosa resection), and emergency surgery, neurological surgery, lymphatic, biliary, and cerebrospinal (CSF) fistulae, and air leakages during thoracic and pulmonal surgery.
  14. 16
    Use according to any of claims 12-15 wherein the carrier is a biodegrable polymer such as a polyhyaluronic acid, polyhydroxy acid, e.g. lactic acid, glucolic acid, hydroxybutanoic acid, a cellulose, gelatine or collagen, such as a collagen sponge, e.g. a collagen sponge consisting essentially of collagen type I fibres.
  15. 17
    Use according to any of claims 12-16 wherein the carrier and has one or more active sides wherein fibrinogen is present in an amount of 2-10 mg//cm2, such as 4.3-6.7 mg/cm2, preferably about 5.5 mg/cm2, and thrombin is present in an amount of 1.5-2.5 IU/cm2, preferably 2.0 IU/cm2
  16. 18
    Use according to any of claims 12-17 wherein the fibrinogen is human, purified from a natural source, or transgenic or recombinant human fibrinogen.
  17. 19
    Use according to any of claims 12-18 wherein the fibrinogen is purified from a natural source.
  18. 20
    Use according to any of claims 12-18 wherein the fibrinogen is transgenic or recombinant.
  19. 21
    Use according to any of claims 12-20 wherein the thrombin is human, purified from a natural source, or transgenic or recombinant human thrombin.
  20. 22
    Use according to any of claims 12-21 wherein the thrombin is purified from a natural source.
  21. 23
    A composition according to any of claims 12-21 wherein the thrombin is transgenic or recombinant.
Independent claims21