U.S. patent application number 10/463873 was filed with the patent office on 2004-02-19 for multi-material incontinence treatment constriction device.
Invention is credited to Forsell, Peter.
Application Number | 20040034275 10/463873 |
Document ID | / |
Family ID | 31188496 |
Filed Date | 2004-02-19 |
United States Patent
Application |
20040034275 |
Kind Code |
A1 |
Forsell, Peter |
February 19, 2004 |
Multi-material incontinence treatment constriction device
Abstract
An implantable constriction device for treating an incontinent
patient comprises an elongate composite structure adapted to
constrict the urethra, urine bladder, anus, colon or rectum of the
patient. The elongate composite structure is composed of a base
material, such as hard silicone, making the composite structure
self-supporting. Property improving means is provided for improving
at least one physical property of the composite structure other
than self-supporting properties, such as fatigue resistance, liquid
impermeability, aggressive body cells resistance, anti-friction
properties and lifetime.
Inventors: |
Forsell, Peter; (Zug,
CH) |
Correspondence
Address: |
NIXON & VANDERHYE, PC
1100 N GLEBE ROAD
8TH FLOOR
ARLINGTON
VA
22201-4714
US
|
Family ID: |
31188496 |
Appl. No.: |
10/463873 |
Filed: |
June 18, 2003 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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60398824 |
Jul 29, 2002 |
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Current U.S.
Class: |
600/31 |
Current CPC
Class: |
A61L 31/088 20130101;
A61L 27/34 20130101; A61L 31/10 20130101; A61L 27/306 20130101;
A61L 27/34 20130101; C08L 65/04 20130101; A61L 31/10 20130101; C08L
65/04 20130101; A61L 31/10 20130101; C08L 27/18 20130101 |
Class at
Publication: |
600/31 |
International
Class: |
A61F 002/02 |
Claims
What is claimed is:
1. An implantable constriction device for treating an incontinent
patient, comprising an elongate composite structure adapted to
constrict the urethra, urine bladder, anus, colon or rectum of the
patient, wherein said elongate composite structure is composed of a
base material making said composite structure self-supporting and
property improving means for improving at least one physical
property of said composite structure other than self-supporting
properties.
2. An implantable constriction device according to claim 1, wherein
said property improving means comprises a coating on said base
material at least along a side of said elongate composite structure
that is intended to contact the urethra, urine bladder, anus, colon
or rectum, said coating having better aggressive body fluid
resistant properties than said base material.
3. An implantable constriction device according to claim 2, wherein
said coating is selected from the group consisting of a Teflon.TM.,
Parylene.TM., and a biocompatible metal coating.
4. An implantable constriction device according to claim 3, wherein
the biocompatible metal coating is selected from the group
consisting of gold, silver and titanium.
5. An implantable constriction device according to claim 2, wherein
said property improving means comprises a core of a viscoelastic
material covered with said self-supporting base material.
6. An implantable constriction device according to claim 5, wherein
hard silicone constitutes said base material.
7. An implantable constriction device according to claim 5, wherein
said viscoelastic material is selected from the group consisting of
silicone gel, cellulose gel, and collagen gel.
8. An implantable constriction device according to claim 2, wherein
said base material forms an inflatable tubing.
9. An implantable constriction device according to claim 8, wherein
said tubing has an inner surface defining the interior of said
tubing, and said coating covers said inner surface.
10. An implantable constriction device according to claim 8,
wherein said coating is selected from the group consisting of
Teflon.TM., Parylene.TM., and a biocompatible metal coating.
11. An implantable constriction device according to claim 10,
wherein the biocompatible metal coating is selected from the group
consisting of gold, silver and titanium.
12. An implantable constriction device according to claim 8,
wherein hard silicone constitutes said base material.
13. An implantable constriction device according to claim 8,
wherein said base material forms two coaxial tubular layers and
said property improving means comprises a tubular intermediate
layer of a viscoelastic material located between said coaxial
tubular layers.
14. An implantable constriction device according to claim 13,
wherein said viscoelastic material is selected from the group
consisting of silicone gel, cellulose gel, and collagen gel.
15. An implantable constriction device according to claim 8,
wherein said base material forms an outer tubular layer, an inner
arcuate layer attached to said outer tubular layer, said outer and
inner layers defining a curved space extending longitudinally along
said tubing, and said property improving means comprises
viscoelastic material filling said space.
16. An implantable constriction device according to claim 15,
wherein said viscoelastic material is selected from the group
consisting of silicone gel, cellulose gel, and collagen gel.
17. An implantable constriction device according to claim 1,
wherein said property improving means comprises a coating on said
base material at least along a side of said elongate composite
structure that is intended to contact the urethra, urine bladder,
anus, colon or rectum, said coating having better anti-friction
properties than said base material.
18. An implantable constriction device according to claim 17,
wherein said coating is selected from the group consisting of a
Teflon.TM., Parylene.TM., and a biocompatible metal coating.
19. An implantable constriction device according to claim 18,
wherein the biocompatible metal coating is selected from the group
consisting of gold, silver and titanium.
20. An implantable constriction device according to claim 17,
wherein said property improving means comprises a core of a
viscoelastic material covered with said self-supporting base
material.
21. An implantable constriction device according to claim 20,
wherein hard silicone constitutes said base material.
22 An implantable constriction device according to claim 20,
wherein said viscoelastic material is selected from the group
consisting of silicone gel, cellulose gel, and collagen gel.
23. An implantable constriction device according to claim 17,
wherein said base material forms an inflatable tubing.
24. An implantable constriction device according to claim 23,
wherein said tubing has an inner surface defining the interior of
said tubing, and said coating covers said inner surface.
25. An implantable constriction device according to claim 23,
wherein said coating is selected from the group consisting of a
Teflon.TM., Parylene.TM., and a biocompatible metal coating.
26. An implantable constriction device according to claim 25,
wherein the biocompatible metal coating is selected from the group
consisting of gold, silver and titanium.
27. An implantable constriction device according to claim 23,
wherein hard silicone constitutes said base material.
28. An implantable constriction device according to claim 23,
wherein said base material forms two coaxial tubular layers and
said property improving means comprises a tubular intermediate
layer of a viscoelastic material located between said coaxial
tubular layers.
29. An implantable constriction device according to claim 28,
wherein said viscoelastic material is selected from the group
consisting of silicone gel, cellulose gel, and collagen gel.
30. An implantable constriction device according to claim 23,
wherein said base material forms an outer tubular layer, an inner
arcuate layer attached to said outer tubular layer, said outer and
inner layers defining a curved space extending longitudinally along
said tubing, and said property improving means comprises a
viscoelastic material filling said space.
31. An implantable constriction device according to claim 30,
wherein said viscoelastic material is selected from the group
consisting of silicone gel, cellulose gel, and collagen gel.
32. An implantable constriction device according to claim 1,
wherein said base material forms a first layer and said property
improving means comprises a second layer applied on said first
layer, said second layer being more fatigue resistant than said
first layer.
33. An implantable constriction device according to claim 32,
wherein said second layer covers said first layer of said base
material along a side of said elongate composite structure that is
intended to contact the urethra, urine bladder, anus, colon or
rectum.
34. An implantable constriction device according to claim 32,
wherein said second layer comprises a polyurethane layer.
35. An implantable constriction device according to claim 32,
wherein said property improving means comprises a coating coated on
said first layer and/or said second layer, said coating having
better aggressive body fluid resistance properties and/or better
anti-friction properties than said base material.
36. An implantable constriction device according to claim 35,
wherein said coating is selected from the group consisting of
Teflon.TM., Parylene.TM., and biocompatible metal coating.
37. An implantable constriction device according to claim 36,
wherein the biocompatible metal coating is selected from the group
consisting of gold, silver and titanium.
38. An implantable constriction device according to claim 32,
wherein hard silicone constitutes said base material.
39. An implantable constriction device according to claim 32,
wherein said first layer of said base material forms an inflatable
tubing, and said second layer covers said base material within said
tubing.
40. An implantable constriction device according to claim 1,
wherein said base material forms an inflatable tubing and said
property improving means comprises a liquid impermeable coating
coated on said base material.
41. An implantable constriction device according to claim 40,
wherein said tubing has an external surface of said base material
and an internal surface of said base material defining the interior
of said tubing, said coating being coated on said external surface
and/or internal surface.
42. An implantable constriction device according to claim 40,
wherein said coating is selected from the group consisting of
Parylene.TM. and a biocompatible metal coating.
43. An implantable constriction device according to claim 42,
wherein the biocompatible metal coating is selected from the group
consisting of gold, silver and titanium.
44. An implantable constriction device according to claim 40,
wherein hard silicone constitutes said base material.
45. An implantable constriction device according to claim 40,
wherein said base material forms two coaxial tubular layers and
said property improving means comprises a tubular intermediate
layer of a viscoelastic material located between said coaxial
tubular layers.
46. An implantable constriction device according to claim 44,
wherein said viscoelastic material comprises silicone gel,
cellulose gel or collagen gel.
47. An implantable constriction device according to claim 40,
wherein said base material forms an outer tubular layer and an
inner arcuate layer attached to said outer tubular layer, said
outer and inner layers defining a curved space extending
longitudinally along said tubing, and said property improving means
comprises viscoelastic material filling said space.
48. An implantable constriction device according to claim 47,
wherein said viscoelastic material is selected from the group
consisting of silicone gel, cellulose gel, and collagen gel.
49. An implantable constriction device according to claim 1,
wherein said property improving means comprises gas contained in a
multiplicity of cavities formed in said base material to improve
the flexibility of said composite structure.
50. An implantable constriction device according to claim 49,
wherein said cavities are defined by net structures of said base
material.
51. An implantable constriction device according to claim 49,
wherein Teflon.TM. constitutes said base material.
52. An implantable constriction device according to claim 49,
wherein said composite structure forms an inflatable tubing.
53. An implantable constriction device for treating an incontinent
patient, comprising an elongate composite structure adapted to
constrict the urethra, urine bladder, anus, colon or rectum of the
patient, wherein the composite structure includes an elongate
biocompatible self-supporting base material having surfaces exposed
to aggressive body cells, when the constriction device is implanted
in the patient, and a cell barrier coating coated on said surfaces
to prevent body cells from breaking down the base material.
54. An implantable constriction device according to claim 53,
wherein said barrier coating is selected from the group consisting
of Parylene.TM. and a biocompatible metal coating.
55. An implantable constriction device according to claim 54,
wherein the biocompatible metal coating is selected from the group
consisting of gold, silver and titanium.
56. An implantable constriction device for treating an incontinent
patient, comprising: elongate means for constricting the urethra,
urine bladder, anus, colon or rectum of the patient, the
constricting means including means for making the constricting
means self-supporting, and means for improving at least one
physical property of said constricting means other than
self-supporting properties.
57. An implantable constriction device according to claim 56,
wherein said property improving means improves the resistance to
aggressive body cells or the anti-friction properties of said
constricting means.
58. An implantable constriction device according to claim 57,
wherein said property improving means comprises a coating on said
self-supporting means at least along a side of said elongate
constricting means that is intended to contact the urethra, urine
bladder, anus, colon or rectum.
59. An implantable constriction device according to claim 58,
wherein said coating is selected from the group consisting of a
Teflon.TM., Parylene.TM., and a biocompatible metal coating.
60. An implantable constriction device according to claim 59,
wherein the biocompatible metal coating is selected from the group
consisting of gold, silver and titanium.
61. An implantable constriction device according to claim 56,
wherein said property improving means improves the flexibility of
said constricting means.
62. An implantable constriction device according to claim 61,
wherein said property improving means comprises a core of a
viscoelastic material covered with said self-supporting base
material.
63. An implantable constriction device according to claim 62,
wherein hard silicone constitutes said self-supporting means.
64. An implantable constriction device according to claim 62,
wherein said viscoelastic material is selected from the group
consisting of silicone gel, cellulose gel, and collagen gel.
65. An implantable constriction device according to claim 61,
wherein said property improving means comprises gas contained in a
multiplicity of cavities formed in said self-supporting means to
improve the flexibility of said constricting means.
66. An implantable constriction device according to claim 65,
wherein said cavities are defined by net structures of said
self-supporting means.
67. An implantable constriction device according to claim 65,
wherein Teflon.TM. constitutes said self-supporting means.
68. An implantable constriction device according to claim 56,
wherein said property improving means improves the fatigue
resistance of said constricting means.
69. An implantable constriction device according to claim 68,
wherein said self-supporting means forms a first layer and said
property improving means comprises a second layer applied on said
first layer, said second layer being more fatigue resistant than
said first layer.
70. An implantable constriction device according to claim 69,
wherein said second layer covers said first layer of said
self-supporting means along a side of said elongate constricting
means that is intended to contact the urethra, urine bladder, anus,
colon or rectum.
71. An implantable constriction device according to claim 69,
wherein said second layer comprises a polyurethane layer.
72. An implantable constriction device according to claim 56,
wherein said property improving means improves the liquid
impermeability of said constricting means.
73. An implantable constriction device according to claim 72,
wherein said self-supporting means forms an inflatable tubing and
said property improving means comprises a liquid impermeable
coating coated on said self-supporting means.
74. An implantable constriction device according to claim 73,
wherein said tubing has an external surface of said self-supporting
means and an internal surface of said self-supporting means
defining the interior of said tubing, said coating being coated on
said external surface and/or internal surface.
75. An implantable constriction device according to claim 73,
wherein said coating is selected from the group consisting of
Parylene.TM. and a biocompatible metal coating.
76. An implantable constriction device according to claim 75,
wherein the biocompatible metal coating is selected from the group
consisting of gold, silver and titanium.
77. An implantable constriction device according to claim 55,
wherein hard silicon constitutes said self-supporting means.
78. An implantable constriction device for treating an incontinent
patient, comprising: an elongate composite structure adapted to
constrict the urethra, urine bladder, anus, colon or rectum of the
patient, a base material of said composite structure making said
composite structure self-supporting, and a coating on said base
material at least along a side of said elongate composite structure
that is intended to contact the urethra, urine bladder, anus, colon
or rectum, said coating having better aggressive body fluid
resistant properties than said base material.
79. An implantable constriction device for treating an incontinent
patient, comprising: an elongate composite structure adapted to
constrict the urethra, urine bladder, anus, colon or rectum of the
patient, a base material of said composite structure making said
composite structure self-supporting, and a coating on said base
material at least along a side of said elongate composite structure
that is intended to contact the urethra, urine bladder, anus, colon
or rectum, said coating having better anti-friction properties than
said base material.
80. An implantable constriction device for treating an incontinent
patient, comprising: an elongate composite structure adapted to
constrict the urethra, urine bladder, anus, colon or rectum of the
patient, a base material of said composite structure making said
composite structure self-supporting, said base material forming a
first layer, and a second layer applied on said first layer, said
second layer being more fatigue resistant than said first
layer.
81. An implantable constriction device for treating an incontinent
patient, comprising: an elongate composite structure adapted to
constrict the urethra, urine bladder, anus, colon or rectum of the
patient, a liquid semi-permeable base material of said composite
structure forming an inflatable tubing and making said composite
structure self-supporting, and a liquid impermeable coating coated
on said base material.
82. An implantable constriction device for treating an incontinent
patient, comprising: an elongate composite structure adapted to
constrict the urethra, urine bladder, anus, colon or rectum of the
patient, and a base material of said composite structure making
said composite structure self-supporting, said base material
forming a multiplicity of gas-containing cavities to improve the
flexibility of said composite structure.
Description
[0001] This application claims the benefit of Provisional
Application No. 60/398,824, filed Jul. 29, 2002, the entire
contents of which is hereby incorporated by reference in this
application.
BACKGROUND OF THE INVENTION
[0002] The present invention relates to an implantable constriction
device for constricting the urethra, urine bladder, anus, colon or
rectum of an incontinent patient.
[0003] This kind of constriction device, in the form of a banding
device in which a band encircles and adjustably constricts a
portion of a patient's urethra, urine bladder, anus, colon or
rectum, has been used in surgery for treating anal and urinary
incontinence. In practice, the band is made of silicone, which is a
material approved and widely used for implantation. Moreover, the
silicone band has an acceptable tensile strength and is fairly
resistant to aggressive body fluids. Where the band is
hydraulically adjusted, the hydraulic fluid used typically is an
isotonic salt solution mixed with other conventional materials.
[0004] A problem with traditional silicone bands, however, is that
the silicone material gives the band certain inadequate properties,
such as poor fatigue resistance and poor endurance of static
bending forces, which over time might result in breakage of the
band. Furthermore, silicone is a material that is semi-permeable by
liquid, which is a drawback to hydraulic silicone bands, because
hydraulic fluid can escape by diffusing through the silicone
material. As a result, accurate adjustments of a hydraulic band are
difficult to perform because of the loss of hydraulic fluid and the
need for the patient to regularly visit a doctor to add hydraulic
fluid to and calibrate the constriction device. These inadequate
properties are serious, considering that the band is implanted for
the rest of the patient's life. Another problem is that the band
somewhat restrains the dynamic movements of adjacent organs
necessary for the transportation of urine or fecal matter. As a
consequence, the band might erode, and over time injure the
urethra, urine bladder, anus, colon or rectum.
SUMMARY OF THE INVENTION
[0005] The object of the present invention is to provide a new
implantable constriction device for treating urinary and anal
incontinence having improved properties as compared to traditional
constriction devices.
[0006] Accordingly, the present invention provides an implantable
constriction device for treating an incontinent patient, the device
comprising an elongate composite structure adapted to constrict the
urethra, urine bladder, anus, colon or rectum of the patient,
wherein the elongate composite structure is composed of a base
material making the composite structure self-supporting and
property improving means for improving at least one physical
property of the composite structure other than self-supporting
properties.
[0007] In accordance with a first embodiment of the invention, the
property improving means comprises a coating on the base material
at least along a side of the elongate composite structure that is
intended to contact the urethra, urine bladder, anus, colon or
rectum, wherein the coating has better aggressive body fluid
resistance than the base material. Such a coating may comprise a
Teflon.TM. or Parylene.TM. coating, or a biocompatible metal
coating such as gold, silver or titanium. As a result, the
constriction device can be protected from damaging influences of
aggressive body fluids, possibly for the rest of the patient's
life.
[0008] Where traditional silicone material constitutes the base
material, a Teflon.TM. or Parylene.TM. coating also provides the
composite structure with better anti-friction properties than the
base material. Good anti-friction properties of the composite
structure reduce the risk of the elongate composite structure
eroding the urethra, urine bladder, anus, colon or rectum. This is
proven by tests, in which the surface of traditional silicone bands
has been polished before use. Accordingly, the test results
indicate significant improvements in avoiding erosion of the
urethra, urine bladder, anus, colon or rectum.
[0009] Furthermore, the Teflon.TM., Parylene.TM. or metal coating
also makes the composite structure, in which the base material is
made of silicone, stronger than the traditional silicone band. A
stronger band reduces the risk of fracture.
[0010] In one alternative to the first embodiment, the elongate
composite structure is designed for mechanical adjustment, such as
the mechanical solutions disclosed in International Application No.
WO 01/45486. In this alternative, the property improving means
comprises a core of a soft viscoelastic material, such as silicone
gel, typically having a hardness less than 20 Shure, cellulose gel
or collagen gel. Where silicone gel is chosen, it may be "Med
3-6300" manufactured by Nusil. Hard silicone constitutes the base
material, typically having a hardness of at least 60 Shure, and
covers the soft core of viscoelastic material. The soft core makes
the implanted elongate composite structure less injurious to the
urethra, urine bladder, anus, colon or rectum, and reduces the
injury of such organs. Furthermore, the soft core of viscoelastic
material may be formed to enclose and protect mechanical adjustment
components and other components of the composite structure, whereby
fibrosis is prevented from growing into such components.
[0011] In another alternative to the first embodiment, the elongate
composite structure is designed for hydraulic adjustment, such as
the hydraulic solutions disclosed in International Application No.
WO 01/50833. In this alternative, the base material forms a closed
tubing, which can be inflated by adding hydraulic fluid to the
interior of the tubing and deflated by withdrawing hydraulic fluid
from the interior of the tubing. The coating of Teflon.TM.,
Parylene.TM. or metal may cover the inner surface of the tubing.
The base material may form two coaxial tubular layers of hard
silicon, and the property improving means may comprise a tubular
intermediate layer of a soft viscoelastic material located between
the coaxial tubular layers. Alternatively, the base material may
form an outer tubular layer and an inner arcuate layer attached to
the outer tubular layer, the outer and inner layers defining a
curved space extending longitudinally along the tubing. The
property improving means may comprise a viscoelastic material
filling the space. The tubing is applied around the urethra, urine
bladder, anus, colon or rectum so that the space with viscoelastic
material is located closest to the urethra, urine bladder, anus,
colon or rectum. The viscoelastic material gives the advantages
that erosion of the urethra, urine bladder, anus, colon or rectum
is reduced and the risk of hydraulic fluid leaking from the tubing
is decreased.
[0012] In accordance with a second embodiment of the invention, the
base material forms a first layer and the property improving means
comprises a second layer applied on the first layer, wherein the
second layer is more fatigue resistant than the first layer. The
first layer preferably is comprised of hard silicone, whereas the
second layer preferably is comprised of a polyurethane layer. In a
traditional silicone band, especially the tubular type, that is
formed in a loop to constrict the urethra, urine bladder, anus,
colon or rectum, the inner surface of the band loop that contacts
the urethra, urine bladder, anus, colon or rectum forms bulges and
creases that repeatedly change as the band is subjected to dynamic
movements from the urethra, urine bladder, anus, colon or rectum
and when the size of the band is adjusted. As a consequence, the
implanted traditional silicone band has the drawback that it may
crack after some time due to fatigue of the silicone material. With
the elongate composite structure of the invention, in which hard
silicone may constitute the base material and a fatigue resistant
polyurethane layer covers the silicone material on the side of the
elongate composite structure that contacts the urethra, urine
bladder, anus, colon or rectum, this drawback is eliminated.
[0013] The property improving means suitably comprises a coating
that may be coated on the layer of hard silicone and/or the layer
of polyurethane, wherein the coating has better aggressive body
fluid resistance properties and/or better anti-friction properties
than hard silicone. As described above in connection with the first
embodiment, the coating may comprise a Teflon.TM. or Parylene.TM.
coating, or a biocompatible metal coating.
[0014] The layer of hard silicone may form an inflatable tubing and
the layer of polyurethane may cover the hard silicone layer within
the tubing.
[0015] In accordance with a third embodiment of the invention, the
base material forms an inflatable tubing and the property improving
means comprises a liquid impermeable coating coated on the base
material. The coating may be coated on the external and/or internal
surface of the tubing. Preferably, the liquid impermeable coating
comprises a Parylener.TM. coating, or a biocompatible metal
coating. Where hard silicone, which is a liquid semi-permeable
material, constitutes the base material, the coating of
Parylene.TM. or metal gives the advantage that the tubing may be
inflated by hydraulic fluid under pressure without risking fluid
diffusing through the silicone wall of the tubing.
[0016] Also, in the third embodiment, the base material may form
two coaxial tubular layers of hard silicon, and the property
improving means may comprise a tubular intermediate layer of a soft
viscoelastic material located between the coaxial tubular layers.
Alternatively, the base material may form an outer tubular layer of
hard silicone and an inner arcuate layer of silicone attached to
the outer tubular layer. The outer and inner layers define a curved
space extending longitudinally along the tubing and filled with the
viscoelastic material. The tubing is intended to be applied around
the urethra, urine bladder, anus, colon or rectum so that the space
with viscoelastic material is located closest to the urethra, urine
bladder, anus, colon or rectum.
[0017] In accordance with a fourth embodiment of the invention, the
property improving means comprises gas, such as air, contained in a
multiplicity of cavities formed in the base material to improve the
flexibility of the composite structure. In this case, Teflon.TM.
advantageously constitutes the base material. The cavities may be
defined by net structures of the Teflon.TM. material. Thus, the
resulting composite structure of Teflon.TM. and cavities filled
with gas is strong, flexible and aggressive body fluid resistant,
and has good tensile strength and good anti-friction properties.
Also, in the fourth embodiment, the elongate composite structure
may comprise an inflatable tubing.
[0018] The present invention also provides an implantable
constriction device for treating an incontinent patient, comprising
an elongate composite structure adapted to constrict the urethra,
urine bladder, anus, colon or rectum of the patient, wherein the
composite structure includes an elongate biocompatible
self-supporting base material having surfaces exposed to aggressive
body cells, when the constriction device is implanted in the
patient, and a cell barrier coating on the surfaces to prevent body
cells from breaking down the base material, which is typically
silicone. If the base material were broken down by such body cells,
typically macrophages or killer cells, histological particles would
be spread in the human body.
[0019] The barrier coating may comprise a Parylene.TM. coating or a
biocompatible metal coating.
[0020] Alternatively, the barrier coating may comprise a composite
of different materials to achieve the cell-barrier protection as
described above. There are several examples of such composite
materials on the market, for example a composite of polyurethane
and silicone called Elaston.TM..
BRIEF DESCRIPTION OF THE DRAWINGS:
[0021] FIG. 1 is a front view of a mechanical constriction device
according to the present invention.
[0022] FIG. 2 is an enlarged cross-section along the line 11-11 in
FIG. 1.
[0023] FIGS. 3 and 4 are modifications of the embodiment shown in
FIG. 2.
[0024] FIG. 5 is a front view of a hydraulic constriction device of
the invention.
[0025] FIG. 6 is an enlarged cross-section along the line VI-VI in
FIG. 5.
[0026] FIGS. 7-10 are modifications of the embodiment shown in FIG.
6.
[0027] FIG. 11 is a modification of the embodiment shown in FIG.
2.
[0028] Referring to the drawing figures, like reference numerals
designate identical or corresponding elements throughout the
several figures.
DETAILED DESCRIPTION OF THE INVENTION
[0029] FIG. 1 illustrates a mechanical constriction device 2
according to the invention comprising an elongate composite
structure 4 adapted to extend around and constrict the urethra,
urine bladder, anus, colon or rectum of a patient. Referring to
FIG. 2, the elongate composite structure 4 comprises a strong band
6 of nylon or the like, a tubular layer 8 of hard silicone, in
which the band 6 slides, a soft layer 10 of a viscoelastic
material, here a silicone gel having a hardness not more than 20
Shure, encircling the hard silicone layer 8, and a tubular layer 12
of a self-supporting base material of hard silicone having a
hardness of at least 60 Shure, surrounding the soft silicon layer
10. A coating 14 of Teflon.TM., Parylene.TM. or a biocompatible
metal, such as gold, silver or titanium, is coated on the outer
hard silicone layer 12 to make the composite structure resistant to
aggressive body fluids and to give the composite structure good
anti-friction properties. A coating of Teflon.TM., Parylene.TM. or
metal may also be coated on the internal surface of the inner
tubular hard silicone layer 8 to reduce the friction between the
nylon band 6 and the layer 8. The constriction device 2 has an
adjustment means 16 that can displace the end portions of the nylon
band 6 relative to each other to either increase or decrease the
constriction of the urethra, urine bladder, anus, colon or
rectum.
[0030] FIG. 3 shows an elongate composite structure 18 similar to
that of FIG. 2, except that a layer 20 of a fatigue resistant
material, here polyurethane, is applied on the hard silicone layer
12 along the inner side of the structure 18 that is intended to
contact the urethra, urine bladder, anus, colon or rectum.
Alternatively, the layer 20 may be tubular and surround the layer
12.
[0031] FIG. 4 shows a cross-section of an elongate composite
structure 22 of an embodiment of the invention, in which Teflon.TM.
constitutes the self-supporting base material, which is formed with
a longitudinal cavity in which a strong nylon band 24 slides.
Property improving means in the form of a gas, here air, contained
in a multiplicity of cavities 26 are formed in the base material to
improve the flexibility thereof.
[0032] FIGS. 5 and 6 show a hydraulic constriction device 28
according to the invention comprising an elongate composite
structure in the form of an inflatable tubing 30, in which the base
material of hard silicone forms an outer tubular layer 32 and an
inner coaxial layer 34. A viscoelastic material, here soft silicone
gel, forms an intermediate layer 36 located between the tubular
layers 32 and 34. Four longitudinal partition walls 38 between the
tubular layers 32 and 34 divide the intermediate layer 36 into four
sections to prevent the silicone gel from displacing in the
circumferential direction of the tubing 30. (Also, the embodiments
according to FIGS. 2 and 3 may be provided with such longitudinal
partition walls.) The outer layer 32 is coated with a coating 40 of
Teflon.TM., Parylener.TM. or metal. Also, the inner layer 34 may be
coated with a coating of Teflon.TM., Parylene.TM. or metal. If a
Parylene.TM. or metal coating is chosen the composite structure
will be completely liquid impermeable.
[0033] FIG. 7 shows a tubing 42 similar to that of FIG. 6, except
that an inner arcuate layer 44 is substituted for the inner tubular
layer 34. The arcuate layer 44 is attached to the outer tubular
layer 32, so that the outer tubular layer 32 and the arcuate layer
44 define a curved space extending longitudinally along the tubing
42. A viscoelastic material, here silicone gel 46, fills the space.
In this embodiment there is no need for partition walls of the kind
shown in the embodiment shown in FIG. 6. The tubing 42 is intended
to be applied around the urethra, urine bladder, anus, colon or
rectum so that the space with the protecting soft silicone gel 46
is located close to the urethra, urine bladder, anus, colon or
rectum.
[0034] As taught by the embodiment of FIG. 7, in the composite
structures shown in FIGS. 2 and 3, the soft silicone gel may
alternatively be applied in a longitudinal space close to the inner
side of the elongate composite structure 4 and 18, respectively,
that is intended to contact the urethra, urine bladder, anus, colon
or rectum.
[0035] In the same manner as described above in connection with the
embodiment of FIG. 3, a layer of a fatigue resistant material, here
polyurethane, may be applied on the outer tubular layer 32 of hard
silicone of the tubing 30 and 42, respectively, along the side of
the tubing 30 and 42, respectively, that is intended to contact the
urethra, urine bladder, anus, colon or rectum, when the tubing 30
and 42, respectively, encircles the urethra, urine bladder, anus,
colon or rectum.
[0036] FIG. 8 shows a cross-section of an elongate composite
structure 48 of an embodiment of the invention, in which Teflon.TM.
constitutes the self-supporting base material, which is formed to
an inflatable tubing 50. Property improving means in the form of
gas contained in a multiplicity of cavities 26 are formed in the
base material to improve the flexibility of the tubing 50.
[0037] FIG. 9 shows a cross-section of a tubular composite
structure of an embodiment of the invention, in which the
self-supporting base material 52 is made of a polymer material
suited for implantation, for example silicone or polyurethane. A
property improving coating 54, for example made of Parylener.TM.,
Teflon.TM. or metal, is applied on the external surface or on both
the external and internal surfaces of the tubular structure
[0038] FIG. 10 shows the same embodiment as FIG. 9, except that the
base material comprises a layer 56 of polyurethane surrounded by a
layer 58 of silicone.
[0039] FIG. 11 shows a cross-section of a mechanical constriction
device of another embodiment of the invention, comprising a double
walled tubing 60, an external wall 62 and an internal wall 64
spaced from the external wall 62, of a self-supporting base
material of hard silicone. The tubing 60 has partition walls 66
dividing the space between the external and internal walls 62 and
64, respectively, of the tubing 60 into longitudinal cells 68,
which are filled with a soft viscoelastic material, for example
silicone gel. The internal wall 64 is coated with a friction
reducing coating 70, for example made of Teflon.TM. or the like. A
strong band 72 of nylon or the like slides in the tubing 60 on the
friction reducing coating 70 to enable adjustment of the
constriction device in the same manner as described above in
connection with the embodiment according to FIGS. 1 and 2.
[0040] Although the present invention has been described in terms
of particular embodiments, it is not intended that the invention be
limited to those embodiments. Modifications of the embodiments
within the spirit of the invention will be apparent to those
skilled in the art. The scope of the invention is defined by the
claims that follow.
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