Nova Patents
EP1539044B1

Film for medical Implantation

Abstract

The present invention features soft tissue implants and methods for making same. The implants can includes a biocompatible film that is rendered porous due to the inclusion of uniformly or non-uniformly patterned cells, and the film has a thickness of less than about 0.015 inches in the event the starting material is non-porous and less than about 0.035 inches in the event the starting material is a microporous film. Multi-film implants can also be made.

EP1539044B1, drawing sheet 1
Sheet 1 of 16

Term

Term ended

Expired 17 July 2023, 3.2 years ago.

  1. Priority
  2. Filed
  3. Granted
  4. Expired
  5. Today

32 claims: 24 independent, 8 dependent

  1. 1
    A non-woven soft tissue implant comprising a porous biocompatible film having a cell pattern, the cell pattern comprising a plurality of unit cells, each unit cell including a pore and a portion of the film extending around the perimeter of the pore to define the pore, and the film having a thickness of less than about 0.381mm (0.015 inches), the porous biocompatible film comprising a non-absorbable polymer or copolymer or the porous biocompatible film comprising an absorbable polymer or copolymer, the polymer or copolymer having biaxially oriented chains, characterised in that the implant having a surface area ratio less than 1.5, where:surface area ratio = Asu/Ac, Asu = the three dimensional surface area of a unit cell, Ac = the two dimensional area of the unit cell.
  2. 4
    The non-woven soft tissue implant of any of claims 1 to 3, wherein one or more of the cells in the plurality of cells has a diameter, measured along the longest axis of the cell, of about 10µ to about 10,000µ.
  3. 7
    The non-woven soft tissue implant of any of claims 1 to 6, wherein one or more of the cells of the plurality are essentially square, rectangular, or diamond-shaped.
  4. 8
    The non-woven soft tissue implant of any of claims 1 to 6, wherein one or more of the cells of the plurality are essentially round or oval-shaped.
  5. 9
    The non-woven soft tissue implant of any of claims 1 to 8, wherein the thickness of the porous biocompatible film is less than about 0.3556mm (0.014 inches), less than about 0.3302mm (0.013 inches), less than about 0.3048mm (0.012 inches), less than about 0.2794mm (0.011 inches), less than about 0.254mm (0.010 inches), less than about 0.2286mm (0.009 inches), less than about 0.2032mm (0.008 inches), less than about 0.1778mm (0.007 inches), less than about 0.1524mm (0.006 inches), less than about 0.127mm (0.005 inches), less than about 0.1016mm (0.004 inches), less than about 0.0762mm (0.003 inches), less than about 0.0508mm (0.002 inches), or is about 0.0254mm (0.001 inch).
  6. 10
    The non-woven soft tissue implant of any of claims 1 to 9, wherein the porous biocompatible film has atraumatic edges.
  7. 11
    The non-woven soft tissue implant of any of claims 1 to 10, wherein the porous biocompatible film is at least about 2.5 cm long along a first side and no more than about 45.0 cm long along a second side.
  8. 12
    The non-woven soft tissue implant of any of claims 1 to 11, wherein the implant is flexible along two axes.
  9. 15
    The non-woven soft tissue implant of any of claims 1 to 14, wherein the cells in the plurality of cells have a diameter greater than 50p and the non-woven soft tissue implant has force displacement characteristics that do not restrict tissue movement, preferably the implant can be distended by 25% or more at 16 N/cm, preferably the pattern of the plurality of cells imparts force displacement characteristics that approximates those of the structure being repaired.
  10. 16
    The non-woven soft tissue implant of any of claims 1 to 15, wherein the porous biocompatible film is a first porous biocompatible film, and the implant comprises a second porous biocompatible film having a cell pattern, the cell pattern comprising a plurality of cells, each cell including a pore and a portion of the film extending around the perimeter of the pore to define the pore, the thickness of the implant being less than about 0.381mm (0.015 inches).
  11. 19
    The non-woven soft tissue implant of any of claims 16 to 18, wherein the first film and the second film are of substantially the same size and a surface of the first film adheres to a surface of the second film.
  12. 20
    The non-woven soft tissue implant of any of claims 16 to 19, wherein the second porous biocompatible film comprises a non-absorbable polymer or copolymer, preferably the non-absorbable polymer or copolymer comprises polypropylene, polyethylene terephthalate, polytetrafluoroethylene, polyaryletherketone, nylon, fluorinated ethylene propylene, polybutester, silicone, polyethylene, or a copolymer of polyethylene and polypropylene.
  13. 21
    The non-woven soft tissue implant of any of claims 16 to 20, wherein the second porous biocompatible film comprises an absorbable polymer or copolymer, preferably the absorbable polymer or copolymer is PGA, PLA, polycaprolactone, or polyhydroxyalkanoate.
  14. 22
    The non-woven soft tissue implant of any of claims 16 to 21, wherein the second porous biocompatible film comprises a biological material, preferably the biological material is collagen.
  15. 23
    The non-woven soft tissue implant of any of claims 16 to 22, wherein the second film comprises a cell having a diameter, measured along the longest axis of the cell, of about 10µ to about 10,000µ;of about 1,500µ, to about 5,000µ;or of about 50µ to about 100µ.
  16. 24
    The non-woven soft tissue implant of any of claims 16 to 23, wherein the second film comprises a cell that is essentially square, rectangular, or diamond-shaped.
  17. 25
    The non-woven soft tissue implant of any of claims 16 to 23, wherein the second film comprises a cell that is essentially round or oval-shaped.
  18. 26
    The non-woven soft tissue implant of any of claims 1 to 25, wherein the thickness of the implant is less than about 0.3556mm (0.014 inches), less than about 0.3302mm (0.013 inches), less than about 0.3048mm (0.012 inches), less than about 0.2794mm (0.011 inches), less than about 0.254mm (0.010 inches), less than about 0.2286mm (0.009 inches), less than about 0.2032mm (0.008 inches), less than about 0.1778mm (0.007 inches), less than about 0.1524mm (0.006 inches), less than about 0.127mm (0.005 inches), less than about 0.1016mm (0.004 inches), less than about 0.0762mm (0.003 inches), less than about 0.0508mm (0.002 inches), or is about 0.0254mm (0.001 inch).
  19. 27
    The non-woven soft tissue implant of any of claims 16 to 26, wherein the first and second films have atraumatic edges.
  20. 28
    The non-woven soft tissue implant of any of claims 1 to 27, wherein the implant is at least 2.5 cm long along a first side and no more than 30.0 cm long along a second side.
  21. 29
    The non-woven soft tissue implant of any of claims 1 to 28, further comprising a film that increases tear resistance, preferably the film that increases tear resistance is a porous biocompatible film.
  22. 30
    The non-woven soft tissue implant of any of claims 16 to 29, wherein the plurality of cells in the second biocompatible film comprises a cell pattern containing a sinusoidal element.
  23. 31
    The non-woven soft tissue implant of any of claims 16 to 30, wherein each of the cells in the plurality of cells in the second biocompatible film has a plurality of undulating elements in the form of a repeating pattern, preferably the undulating elements are in phase.
  24. 32
    The non-woven soft tissue implant of any of claims 16 to 31, wherein the cells in the plurality of cells in the second biocompatible film have a diameter greater than 50µ and the non-woven soft tissue implant has force displacement characteristics that do no restrict tissue movement when placed in a body, preferably the implant can be distended by 25% or more at 16N/cm, preferably the pattern of the plurality of cells imparts force displacement characteristics that approximates those of the structure being repaired.
Independent claims24