Canadian Patents Database / Patent 2279902 Summary

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(12) Patent: (11) CA 2279902
(54) English Title: METHOD FOR USING TROPOELASTIN AND FOR PRODUCING TROPOELASTIN BIOMATERIALS
(54) French Title: PROCEDE POUR UTILISER LA TROPOELASTINE ET POUR PRODUIRE DES BIOMATERIAUX A BASE DE TROPOELASTINE
(51) International Patent Classification (IPC):
  • A61L 27/36 (2006.01)
  • A61L 27/14 (2006.01)
  • A61L 27/22 (2006.01)
  • A61L 27/38 (2006.01)
  • A61L 27/40 (2006.01)
  • A61L 31/04 (2006.01)
  • A61L 27/06 (2006.01)
  • A61L 31/02 (2006.01)
  • A61F 2/04 (2006.01)
  • A61F 2/82 (2006.01)
(72) Inventors (Country):
  • BAROFSKY, ANDREW D. (United States of America)
  • GREGORY, KENTON W. (United States of America)
(73) Owners (Country):
  • GREGORY, KENTON W. (United States of America)
  • PROVIDENCE HEALTH SYSTEM - OREGON (United States of America)
(71) Applicants (Country):
  • SISTERS OF PROVIDENCE IN OREGON (United States of America)
  • GREGORY, KENTON W. (United States of America)
(74) Agent: SIM & MCBURNEY
(45) Issued: 2009-01-13
(86) PCT Filing Date: 1998-02-06
(87) PCT Publication Date: 1998-08-13
Examination requested: 2000-12-06
(30) Availability of licence: N/A
(30) Language of filing: English

(30) Application Priority Data:
Application No. Country Date
08/797,770 United States of America 1997-02-07

English Abstract



It is a general object of the invention to provide a method of effecting
repair or replacement or supporting a section of a body tissue
using tropoelastin, preferably cross-linked tropoelastin and specifically to
provide a tropoelastin biomaterial suitable for use as a stent, for
example, a vascular stent, or as conduit replacement, as an artery, vein or a
ureter replacement. The tropoelastin biomaterial itself can also
be used as a stent or conduit covering or coating or lining.


French Abstract

L'objectif général de l'invention est de proposer une méthode permettant de réparer, de remplacer ou de supporter une partie d'un tissu corporel au moyen de tropoélastine, de préférence de tropoélastine réticulée. Son objectif spécifique est de proposer un biomatériau à base de tropoélastine pouvant être utilisé comme endoprothèse, endoprothèse vasculaire par exemple, ou comme substitut de conduit, artère, veine ou uretère par exemple. Le biomatériau à base de tropoélastine lui-même peut également être utilisé comme couche de protection ou comme revêtement pour une endoprothèse ou un conduit.


Note: Claims are shown in the official language in which they were submitted.


37
WHAT IS CLAIMED IS:

1. A method for producing a tropoelastin biomaterial
fused onto a tissue substrate comprising:

providing a layer of biomaterial consisting
essentially of tropoelastin having a first and second
outer major surface and a tissue substrate having a first
and second outer major surface; and

applying an energy absorbing material, which is
energy absorptive within a predetermined range of light
wavelengths, to a selected one of said first and second
outer surfaces of the tropoelastin biomaterial in an
amount which will cause fusing together of one of said
first and second outer surfaces of the tropoelastin
biomaterial and one of said first and second outer
surfaces of said tissue substrate, said energy absorbing
material penetrating into the interstices of said
tropoelastin biomaterial;
irradiating the energy absorbing material with light
energy in said predetermined wavelength range with an
intensity sufficient to fuse together one of said first
and second outer surfaces of the tropoelastin biomaterial
and the tissue substrate; and
fusing together the selected one of said first and
second outer surfaces of the tropoelastin biomaterial and
the tissue substrate.

2. The method of claim 1, wherein the step of
irradiating further comprises indirectly irradiating said
energy absorbing material by directing the light energy
first through the tropoelastin biomaterial or tissue
substrate and then to the energy absorbing material.


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3. The method of claim 1, wherein said energy absorbing
material comprises a biocompatible chromophore.

4. The method of claim 1, wherein said energy absorbing
material comprises an energy absorbing dye.

5. The method of claim 1, which further comprises a
step of substantially dissipating said energy absorbing
material when said tropoelastin biomaterial and said
tissue substrate are fused together.

6. The method of claim 1, wherein the step of applying
said energy absorbing material further comprises staining
the first or second surface of said tropoelastin
biomaterial with said energy absorbing material.

7. The method of claim 1, which further comprises the
step of applying said energy absorbing material to one of
said outer surfaces of said biomaterial by doping a
separate tropoelastin layer with an energy absorbing
material, and then fusing the doped separate tropoelastin
layer to the tropoelastin biomaterial.

8. The method of claim 1, wherein the energy absorbing
material is substantially uniformly applied to a selected
one of said first and second outer surfaces of the
tropoelastin biomaterial.

9. The method of claim 1, which further comprises a
step of substantially covering the outer surface of the
tropoelastin biomaterial with the energy absorbing
material.


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10. The method of claim 1, which further comprises the
step of irradiating the energy absorbing material with
light energy at a localized temperature of from about 40
to 600 °C for a period of time sufficient to cause fusing
together of one of said first and second outer surfaces
of the tropoelastin biomaterial and one of said first and
second outer surfaces of said tissue substrate.

11. The method of claim 1, wherein the tissue substrate
is a live tissue substrate.

12. The method of claim 1, wherein the average thickness
of the energy absorbing material which penetrates into
the interstices of the tropoelastin biomaterial is from
about 0.5 to 300 microns.

13. The method of claim 1, which further comprises a
step of arranging the magnitude of the wavelength,
absorption, and light intensity during irradiation with
light energy of the energy absorbing material, and the
concentration of the energy absorbing material, so that
localized temperature at the interface of said first and
second outer surfaces of the tropoelastin biomaterial and
the tissue substrate are maintained at from about 40 to
600 °C, thereby fusing together the tropoelastin
biomaterial and the tissue substrate.

14. The method of claim 1, wherein the tissue substrate
is selected from a group consisting of bladders,
intestines, tubes, esophagus, ureters, arteries, veins,
stomachs, lungs, hearts, colons, skins and a cosmetic
implant.


40
15. The method of claim 1, which further comprises a
step of forming a tropoelastin into a three-dimensional
support structure wherein said tropoelastin material is
combined with a stromal support matrix populated with
actively growing stromal cells.

16. The method of claim 15, wherein the stromal support
matrix comprises fibroblasts.

17. The method of claim 1, which further comprises a
step of forming a cellular lining of human cells on one
of said first and second outer surfaces of said
tropoelastin layer.

18. The method of claim 17, wherein said cells which are
employed to form the lining are at least one of
endothelial cells, epithelial cells and urothelial cells.
19. The method of claim 1, which further comprises a
step of forming a tropoelastin biocompatible inner lining
for mechanical human structures to ensure their continued
internal use in a human body.

20. The method of claim 19, which further comprises the
step of forming a tropelastin biocompatible inner lining
in at least one of heart valves, heart implants, dialysis
equipment, and oxygenator tubing for heart-lung by-pass
systems.

21. The method of claim 1, which further comprises a
step of introducing a drug into said biomaterial.


41
22. A method for using a tropoelastin biomaterial as a
tissue-fusible layer, comprising:

providing a layer of biomaterial consisting
essentially of tropoelastin having a first and second
outer major surface which is for use as a tissue-fusible
material;
providing a tissue substrate having a first and
second outer major surface; and

using said tropoelastin biomaterial as a heat
fusible material by applying an energy absorbing
material, which is energy absorptive within a
predetermined range of light wavelengths, to one of said
first and second outer surfaces of the tropoelastin
biomaterial in an amount which will make said
tropoelastin biomaterial tissue-fusible, and which will
cause fusing together of one of said first and second
outer surfaces of the tropoelastin biomaterial and one of
said first and second outer surfaces of said tissue
substrate, said energy absorbing material being applied
so that it will penetrate into the interstices of said
tropoelastin biomaterial,
irradiating the energy absorbing material with light
energy in said predetermined wavelength range with an
intensity being sufficient to fuse together one of said
first and second outer surfaces of the tropoelastin
biomaterial and the tissue substrate.

23. A method for producing a tropoelastin biomaterial
fused onto a tissue substrate comprising:
providing a layer of biomaterial consisting
essentially of tropoelastin having a first and second
outer major surface and a tissue substrate having a first
and second outer major surface;


42
applying an energy absorbing material, which is

energy absorptive within a predetermined range of light
wavelengths, to one of said first and second outer
surfaces of the tropoelastin biomaterial in an amount
which will cause fusing together of one of said first and
second outer surfaces of the tropoelastin biomaterial and
one of said outer surface of said tissue substrate, said
energy absorbing material penetrating into the
interstices of said tropoelastin biomaterial;
indirectly irradiating the energy absorbing material
by directing the light energy first through the
tropoelastin biomaterial or tissue substrate and then to
the energy absorbing material, said light energy being in
said predetermined wavelength range with an intensity
sufficient to fuse together one of said first and second
outer surfaces of the tropoelastin biomaterial and the
outer surface of said tissue substrate; and
fusing together one of said first and second outer
surfaces of the tropoelastin biomaterial and the outer
surface of said tissue substrate and substantially
dissipating said energy absorbing material when said
tropoelastin biomaterial and said tissue substrate are
fused together.

24. A prosthetic device comprising:
a support member comprising one of a stent, a
conduit and a scaffold; and
a layer of a biomaterial consisting essentially of
tropoelastin located on said support member.

25. The prosthetic device of claim 24, wherein the layer
of said tropoelastin biomaterial completely surrounds
said support member.


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26. The prosthetic device of claim 24, wherein said
support member is formed of a metal.

27. The prosthetic device of claim 24, wherein said
support member is formed of a synthetic material.
28. The prosthetic device of claim 27, wherein said
synthetic material comprises a polymeric material.
29. The prosthetic device of claim 28, wherein said
polymeric material is selected from a group consisting of
polyethylene terepthalate (Dacron)TM, Goretex TM, teflon TM,
polyolefin copolymer, polyurethane and polyvinyl alcohol.
30. The prosthetic device of claim 24, wherein said
support member is formed from a hybrid polymer comprising
a synthetic polymeric material and a natural polymeric
material comprising tropoelastin.

31. The prosthetic device of claim 24, wherein said
support member is formed from a biological material.
32. The prosthetic device of claim 31, wherein said
biological material comprises collagen.

33. The prosthetic device of claim 24, wherein the layer
of tropoelastin material comprises one of a covering, a
coating, and a lining for said support member.

34. The prosthetic device of claim 24 for use as an
implant within at least one of a vessel, an artery, a




44


vein, an esophagus, a liver, an intestine, a colon, a
ureter, a urethra, and a fallopian tube.


35. A method for producing a prosthetic device
comprising:
providing a layer consisting essentially of
tropoelastin biomaterial and a support member comprising
one of a stent, a conduit and scaffold; and
applying said layer consisting essentially of
tropoelastin biomaterial to said support member to form
said prosthetic device.


36. The method of claim 35, which comprises the step of
applying the layer of said tropoelastin biomaterial so
that it surrounds said support member.


37. The method of claim 35, which comprises the step of
forming said tropoelastin biomaterial by polymerization.

38. The method of claim 35, which comprises a step of
molding said tropoelastin biomaterial of a suitable size
and shape.


39. The method of claim 37, which further comprises a
step of cross-linking the polymerized tropoelastin
biomaterial by cross-linking using gamma radiation or
through the use of a cross-linking agent.


40. The method of claim 35, which comprises the step of
forming said tropoelastin biomaterial into a sheet or
tube, and then covering said support member with said
sheet or tube.





45


41. The method of claim 40, which comprises a step of
attaching said sheet to said support by grafting.


42. The method of claim 40, which comprises a step of
attaching said sheet to said support by mechanical
bonding.


43. The method of claim 40, which comprises a step of
attaching said sheet to said support by laser bonding.

44. The method of claim 35, which comprises a step of
incorporating a drug into said layer of tropoelastin
material.


45. The method of claim 35, wherein said support member
comprises one of titanium, tantalum, stainless steel and
nitinol.TM..


46. A method for producing a tropoelastin biomaterial,
which comprises:

providing a monomer consisting essentially of
tropoelastin;
polymerizing said tropoelastic monomer to form a
polymer consisting essentially of tropoelastin; and
forming a biocompatible tropoelastin biomaterial
from said tropoelastin polymer.


47. The method of claim 46, wherein the tropoelastin
biomaterial is fusible onto a tissue substrate, wherein
the tissue substrate is selected from a group consisting
of bladders, intestines, tubes, esophagus, ureters,
arteries, veins, stomachs, lungs, hearts, colons, skins
and a cosmetic implant.





46


48. The method of claim 46, which further comprises the
step of forming a tropoelastin into a three-dimensional
support structure wherein said tropoelastin material is
combined with a stromal support matrix populated with
actively growing stromal cells.


49. The method of claim 48, wherein the stromal support
matrix comprises fibroblasts.


50. The method of claim 46, which further comprises the
step of forming a cellular lining of human cells on one
of the major surfaces of said biocompatible tropoelastin
biomaterial.


51. The method of claim 50, wherein said human cells are
selected from a group consisting of endothelial cells,
epithelial cells and urothelial cells.


52. The method of claim 46, which further comprises the
step of forming a tropoelastin biocompatible inner lining
for mechanical human structures to ensure their continued
internal use in a human body.


53. The method of claim 46, which further comprises the
step of forming a tropelastin biocompatible inner lining
in at least one of heart valves, heart implants, dialysis
equipment, and oxygenator tubing for heart-lung by-pass
systems.


54. The method of claim 46, which comprises a step of
introducing a drug into said biomaterial.





47


55. A method for using a tropoelastin polymer, which
comprises:

providing a monomer consisting essentially of
tropoelastin;
polymerizing said tropoelastic monomer to form said
tropoelastin polymer;

forming a biocompatible tropoelastin biomaterial
from said tropoelastin polymer; and
using said biocompatible tropoelastin biomaterial in
biomedical applications.


56. Use of the tropoelastin material of claim 55 for
replacement or repair of at least one of bladders,
intestines, tubes, esophagus, ureters, arteries, veins,
stomachs, lungs, hearts, colons, skins and a cosmetic
implant.


57. The method of claim 55, which further comprises the
step of forming a tropoelastin into a three-dimensional
support structure wherein said tropoelastin material is
combined with a stromal support matrix populated with
actively growing stromal cells.


58. The method of claim 57, wherein said stromal support
matrix comprise fibroblasts.


59. The method of claim 55, wherein said biocompatible
tropoelastin biomaterial is a tropoelastin layer having a
first and second outer major surface, the method further
comprising the step of forming a cellular lining of human
cells on one of the first and second outer major surfaces
of said tropoelastin layer.




48

60. The method of claim 59, wherein said cells which are
employed to form the lining are at least one of
endothelial cells, epithelial cells and urothelial cells.

61. The method of claim 55, which further comprises the
step of forming a tropoelastin biocompatible inner lining
for mechanical human structures to ensure their continued
internal use in a human body.


62. The method of claim 61, wherein the biocompatible
inner lining is employed in at least one of heart valves,
heart implants, dialysis equipment, and oxygenator tubing
for heart-lung by-pass systems.


63. The method of claim 55, which comprises a step of
incorporating a drug into said biomaterial.


64. A tropoelastin biomaterial and tissue composite
product, which comprises:
a layer of biomaterial consisting essentially of
tropoelastin having a first and second outer major
surface;
a tissue substrate having a first and second outer
major surface; and
an energy absorbing material, which is energy
absorptive within a predetermined range of light
wavelengths, disposed on one of said first and second
outer surfaces of the tropoelastin biomaterial in an
amount which will cause fusing together of one of said
first and second outer surfaces of the tropoelastin
biomaterial and one of said first and second outer
surfaces of said tissue substrate,





49


one of said first and second outer surfaces of the
tropoelastin biomaterial and the tissue substrate being
fused together by said energy absorbing material which
penetrates into the interstices of said tropoelastin
biomaterial.


65. Use of the tropoelastin biomaterial of claim 64 for
replacement or repair of at least one of bladders,
intestines, tubes, esophagus, ureters, arteries, veins,
stomachs, lungs, hearts, colons, skins and a cosmetic
implant.


66. The method of claim 64, which further comprises the
step of forming a tropoelastin into a three-dimensional
support structure wherein said tropoelastin biomaterial
is combined with a stromal support matrix populated with
actively growing stromal cells.


67. The method of claim 66, wherein said stromal support
matrix comprise fibroblasts.


68. The method of claim 64, which further comprises the
step of forming a cellular lining of human cells on one
of said first and second outer major surfaces of said
tropoelastin layer.


69. The method of claim 68, wherein said cells which are
employed to form such a lining are at least one of
endothelial cells, epithelial cells and urothelial cells.

70. The method of claim 64, which further comprises the
step of forming a tropoelastin biocompatible inner lining




50


for mechanical human structures to ensure their continued
internal use in a human body.


71. The method of claim 70, wherein the biocompatible
inner lining is employed in at least one of heart valves,
heart implants, dialysis equipment, and oxygenator tubing
for heart-lung by-pass systems.


72. The method of claim 64, which comprises a step of
incorporating a drug into said biomaterial.


73. A method for producing a biomaterial consisting
essentially of tropoelastin for fusion onto a tissue
substrate comprising:

providing a layer of biomaterial consisting
essentially of tropoelastin having a first and second
outer major surface; and
applying an energy absorbing material, which is
energy absorptive within a predetermined range of light
wavelengths, to a selected one of said first and second
outer surfaces of the tropoelastin biomaterial in an
amount which will cause fusing together of one of said
first and second outer surfaces of the tropoelastin
biomaterial and an outer surface of said tissue
substrate, said energy absorbing material penetrating
into the interstices of said tropoelastin biomaterial,
the selected one of said first and second outer
surfaces of the tropoelastin biomaterial being capable of
fusing together with the outer surface of the tissue
substrate by irradiating the energy absorbing material
with light energy in a predetermined wavelength range
with an intensity sufficient to facilitate said fusing
together.




51



74. A tropoelastin biomaterial for fusion onto a tissue
substrate comprising:
a layer of biomaterial consisting essentially of
tropoelastin having a first and second outer major
surface; and
an energy absorbing material, which is energy
absorptive within a predetermined range of light
wavelengths, applied to a selected one of said first and
second outer surfaces of the tropoelastin biomaterial in
an amount which will cause fusing together of one of said
first and second outer surfaces of the tropoelastin
biomaterial and an outer surface of said tissue
substrate, said energy absorbing material penetrating
into the interstices of said tropoelastin biomaterial,

the selected one of said first and second outer
surfaces of the tropoelastin biomaterial being capable of
fusing together with the outer surface of the tissue
substrate by irradiating the energy absorbing material
with light energy in a predetermined wavelength range
with an intensity sufficient to facilitate said fusing
together.



A single figure which represents the drawing illustrating the invention.

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Admin Status

Title Date
(86) PCT Filing Date 1998-02-06
(87) PCT Publication Date 1998-08-13
(85) National Entry 1999-08-06
Examination Requested 2000-12-06
(45) Issued 2009-01-13
Lapsed 2015-02-06

Payment History

Fee Type Anniversary Year Due Date Amount Paid Paid Date
Registration of Documents $100.00 1999-08-06
Filing $300.00 1999-08-06
Maintenance Fee - Application - New Act 2 2000-02-07 $100.00 1999-08-06
Registration of Documents $50.00 2000-06-09
Request for Examination $400.00 2000-12-06
Maintenance Fee - Application - New Act 3 2001-02-06 $100.00 2001-01-22
Maintenance Fee - Application - New Act 4 2002-02-06 $100.00 2002-01-30
Registration of Documents $100.00 2002-11-12
Maintenance Fee - Application - New Act 5 2003-02-06 $150.00 2003-01-30
Maintenance Fee - Application - New Act 6 2004-02-06 $200.00 2004-02-04
Maintenance Fee - Application - New Act 7 2005-02-07 $200.00 2005-02-04
Maintenance Fee - Application - New Act 8 2006-02-06 $200.00 2006-02-03
Maintenance Fee - Application - New Act 9 2007-02-06 $200.00 2007-01-30
Maintenance Fee - Application - New Act 10 2008-02-06 $250.00 2008-02-01
Final $300.00 2008-10-24
Maintenance Fee - Patent - New Act 11 2009-02-06 $250.00 2009-02-02
Maintenance Fee - Patent - New Act 12 2010-02-08 $250.00 2010-02-05
Maintenance Fee - Patent - New Act 13 2011-02-07 $450.00 2011-02-17
Maintenance Fee - Patent - New Act 14 2012-02-06 $450.00 2012-06-18
Maintenance Fee - Patent - New Act 15 2013-02-06 $450.00 2013-01-17

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