U.S. patent application number 11/586280 was filed with the patent office on 2007-03-29 for artificial urinary diversion device.
Invention is credited to Dieter Jocham, Helmut Wassermann.
Application Number | 20070073413 11/586280 |
Document ID | / |
Family ID | 27219039 |
Filed Date | 2007-03-29 |
United States Patent
Application |
20070073413 |
Kind Code |
A1 |
Wassermann; Helmut ; et
al. |
March 29, 2007 |
Artificial urinary diversion device
Abstract
An artificial urinary diversion device containing a urinary
bladder is provided including first, second and third portions
having respective cross-sectional surfaces such that the second
portion is disposed between the first and third portions, and the
first and second cross-sectional surfaces are smaller than the
third cross-sectional surfaces, and a dislocator for sensing or
controlling the artificial urinary diversion device.
Inventors: |
Wassermann; Helmut;
(Munchen, DE) ; Jocham; Dieter; (Lubeck,
DE) |
Correspondence
Address: |
LERNER, DAVID, LITTENBERG,;KRUMHOLZ & MENTLIK
600 SOUTH AVENUE WEST
WESTFIELD
NJ
07090
US
|
Family ID: |
27219039 |
Appl. No.: |
11/586280 |
Filed: |
October 24, 2006 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10101652 |
Mar 20, 2002 |
7131996 |
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11586280 |
Oct 24, 2006 |
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09936721 |
Dec 19, 2001 |
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PCT/EP00/02407 |
Mar 17, 2000 |
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10101652 |
Mar 20, 2002 |
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Current U.S.
Class: |
623/23.65 ;
600/30 |
Current CPC
Class: |
A61F 2/042 20130101;
A61F 2/02 20130101 |
Class at
Publication: |
623/023.65 ;
600/030 |
International
Class: |
A61F 2/04 20060101
A61F002/04 |
Foreign Application Data
Date |
Code |
Application Number |
Mar 18, 1999 |
DE |
199 12 218.0 |
Mar 19, 1999 |
DE |
199 12 472.8 |
Claims
1. An artificial urinary diversion device comprising a urinary
bladder, having an axial direction and comprising at least one
first portion having a plurality of first cross-sectional areas
perpendicular to said axial direction defining both the outer
surface and the inner volume of said first portion, said at least
one first portion including at least one largest first
cross-sectional area and at least one outlet, at least one second
portion having a plurality of second cross-sectional areas
perpendicular to said axial direction defining both the outer
surface and the inner volume of said second portion, said at least
one second portion including at least one largest second
cross-sectional area, and at least one third portion having a
plurality of third cross-sectional areas perpendicular to said
axial direction defining both the outer surface and the inner
volume of said at least one third portion, said at lest one third
portion including at least one largest third cross-sectional area
and at least one inlet for attachment to the renal urethra of a
patient, said at least one second portion being arranged between
said at least one first portion and said at least one third
portion, a sphincter mechanism for opening and closing said at
least one outlet and being disposed at at least one of said at
least one first, second or third portions, and control means for
controlling said opening and closing of said sphincter mechanism
for emptying said urinary bladder.
2. The artificial urinary diversion device according to claim 1
wherein said largest first cross-sectional area is larger than said
largest second cross-sectional area.
3. The artificial urinary diversion device according to claim 1
including fluid guidance means for guiding fluid from said urinary
bladder through said at least one third portion, said at least one
second portion and said at least one first portion.
4. The urinary diversion device according to claim 1 including an
actuator for actuating said urinary bladder.
5. The artificial urinary diversion device according to claim 4
wherein said actuator comprises a pump.
6. The artificial urinary diversion device according to claim 5
wherein said pump is disposed in said at least one third
portion.
7. The artificial urinary diversion device according to claim 5
wherein said pump comprises a telescopic pump device.
8. The artificial urinary diversion device according to claim 5
wherein said pump comprises a leveler pump including two
chambers.
9. The artificial urinary diversion device according to claim 5
wherein said pump comprises a screw pump.
10. The artificial urinary diversion device according to claim 1
including control means for controlling said sphincter
mechanism.
11. The artificial urinary diversion device according to claim 10
including a pump, wherein said control means controls said
pump.
12. The artificial urinary diversion device according to claim 11
including secondary batteries, and wherein said control means
controls the recharge of said secondary batteries.
13. The artificial urinary diversion device according to claim 1
including a sensor system for monitoring the filling level of said
urinary bladder.
14. The artificial urinary diversion device according to claim 13
including signal means whereby said sensor system produces a signal
when reaching a predetermined filling level of said urinary
bladder.
15. The artificial urinary diversion device according to claim 14
wherein said signal comprises an audible or a vibratory signal.
16. The artificial urinary diversion device according to claim 13
wherein said sensor system is controlled by the nerves responsible
for natural urinary bladder control.
17. The artificial urinary diversion device according to claim 1
including a power supply.
18. The artificial urinary diversion device according to claim 17
including an external recharge device whereby said external
recharge device cooperates with said power supply.
19. The artificial urinary diversion device according to claim 18
wherein said external recharge device cooperates inductively with
said power supply.
20. The artificial urinary diversion device according to claim 17
wherein said power supply comprises primary batteries integrated
into said artificial urinary diversion device.
21. The artificial urinary diversion device according to claim 1
including an actor system for executing the removal of urine from
said artificial urinary diversion device.
22. The artificial urinary diversion device according to claim 1
wherein said at least one third portion is divided into two parts
which can be separated from each other depending on the filling
level of said urinary bladder.
23. The artificial urinary diversion device according to claim 1
wherein said at least one third portion includes either one or two
inlets.
24. The artificial urinary diversion device according to claim 1
including at least one anti-reflux valve.
25. The artificial urinary diversion device according to claim 24
wherein said at least one anti-reflux valve is disposed in said at
least one third portion.
26. The artificial urinary diversion device according to claim 1
including a fixing element for fixing said artificial urinary
diversion device within said patient.
27. The artificial urinary diversion device according to claim 26
including a dovetail joint, and wherein said fixing element is
connected with said artificial urinary diversion device by means of
said dovetail joint.
28. The artificial urinary diversion device according to claim 26
including a guide rail means whereby said fixing element can be
removably included and locked at a predetermined position.
29. The artificial urinary diversion device according to claim 28
wherein said guide rail means is integrated into said at least one
third portion.
30. The artificial urinary diversion device according to claim 26
wherein said fixing element comprises a splay or expanding
element.
31. The artificial urinary diversion device according to claim 26
wherein said fixing element is composed of a biocompatible, elastic
material.
32. The artificial urinary diversion device according to claim 31
wherein said biocompatible, elastic material comprises
silicone.
33. An artificial organ having an axial direction and comprising at
least a first portion having a first cross-sectional surface
perpendicular to said axial direction, a second portion having a
second cross-sectional surface perpendicular to said axial
direction, and a third portion having a third cross-sectional
surface perpendicular to said axial direction, an inlet to said
artificial organ, an outlet from said artificial organ, electronic
operating means disposed within said artificial organ for operating
preselected functions of said artificial organ, and a dislocation
device for sensing or controlling said electronic operating means,
said dislocation device being disposed remotely from said
artificial organ.
34. The artificial organ according to claim 33 wherein said
dislocation device includes control means.
35. The artificial organ according to claim 34 including a pump,
and wherein said control means controls said pump.
36. The artificial organ according to claim 35 including secondary
batteries and wherein said control means controls the recharge of
said secondary batteries.
37. The artificial organ according to claim 33 including a sensor
system for monitoring said electronic operating means.
38. The artificial organ according to claim 37 including signal
means whereby said sensor system produces a signal when reaching a
predetermined parameter for said electronic operating means.
39. The artificial organ according to claim 38 wherein said signal
comprises an audible or a vibratory signal.
40. The artificial organ according to claim 33 including a power
supply.
41. The artificial organ according to claim 40 including an
external recharge device whereby said external recharge device
cooperates with said power supply.
42. The artificial organ according to claim 41 wherein said
external recharge device cooperates inductively with said power
supply.
43. The artificial organ according to claim 40 wherein said power
supply comprises secondary batteries integrated into said
artificial organ.
44. The artificial organ according to claim 40 wherein said power
supply comprises primary batteries integrated into said artificial
organ.
45. The artificial organ according to claim 41 wherein said
external recharge device is disposed within said dislocation
device.
46. The artificial organ according to claim 45 wherein said
dislocation device includes a display for indicating said
dislocation.
47. The artificial organ according to claim 46 wherein said display
includes a level indicator for a fluid level within said artificial
organ.
48. The artificial organ according to claim 33 wherein said
dislocation device comprises an abdominal bandage and includes a
separate control mechanism.
49. The artificial organ according to claim 33 wherein said
dislocation device is integrated into a garment.
50. The artificial organ according to claim 46 including an
ultrasonic transmitter and a receiver device for controlling said
display.
51. The artificial organ according to claim 50 wherein said
ultrasonic transmitter and receiver device includes external Reed
contacts, a Hall generator, and a charging current unit of
measurement or a power sensor.
52. The artificial organ according to claim 33 including an actor
system for executing the removal of a liquid from said artificial
organ.
53. The artificial organ according to claim 33 including a fixing
element for fixing said artificial organ within a patient.
54. The artificial organ according to claim 53 including a dovetail
joint, and wherein said fixing element is connected with said
artificial organ by means of said dovetail joint.
55. The artificial organ according to claim 53 including guide rail
means whereby said fixing element can be removably included and
locked at a predetermined position.
56. An artificial urinary diversion device containing a urinary
bladder, having an axial direction and comprising at least one
first portion having a first cross-sectional surface perpendicular
to said axial direction and including at least one outlet, a second
portion having a second cross-sectional surface perpendicular to
said axial direction, and a third portion having a third
cross-sectional surface perpendicular to said axial direction, and
including at least one inlet for accommodating said urinary
bladder, said second portion being arranged between said first
portion and said third portion, said first and second
cross-sectional surfaces being smaller than said third
cross-sectional surface, and a dislocation device for sensing or
controlling said artificial urinary diversion device.
57. The artificial urinary diversion device according to claim 56
including fluid guidance means for guiding a fluid from said
urinary bladder through said third portion, said second portion,
and said first portion.
58. The artificial urinary diversion device according to claim 56
including an actuator for actuating said urinary bladder.
59. The artificial urinary diversion device according to claim 58
wherein said actuator comprises a pump.
60. The artificial urinary diversion device according to claim 59
wherein said pump is disposed in said third portion.
61. The artificial urinary diversion device according to claim 56
including a sphincter mechanism.
62. The artificial urinary diversion device according to claim 61
wherein said sphincter mechanism is disposed in said first
portion.
63. The artificial urinary diversion device according to claim 56
wherein said dislocation device includes control means.
64. The artificial urinary diversion device according to claim 63
including a sphincter mechanism, and wherein said control means
controls said sphincter mechanism.
65. The artificial urinary diversion device according to claim 63
including a pump, and wherein said control means controls said
pump.
66. The artificial urinary diversion device according to claim 63
including secondary batteries, and wherein said control means
controls the recharge of said secondary batteries.
67. The artificial urinary diversion device according to claim 56
including a sensor system for monitoring the filling level of said
urinary bladder.
68. The artificial urinary diversion device according to claim 67
including signal means whereby said sensor system produces a signal
when reaching a predetermined filling level of said urinary
bladder.
69. The artificial urinary diversion device according to claim 68
wherein said signal comprises an audible or a vibratory signal.
70. The artificial urinary diversion device according to claim 67
wherein said sensor system is controlled by the nerves responsible
for natural urinary bladder control.
71. The artificial urinary diversion device according to claim 56
including a power supply.
72. The artificial urinary diversion device according to claim 71
including an external recharge device whereby said external
recharge device cooperates with said power supply.
73. The artificial urinary diversion device according to claim 72
wherein said external recharge device cooperates inductively with
said power supply.
74. The artificial urinary diversion device according to claim 71
wherein said power supply comprises secondary batteries integrated
into said artificial urinary diversion device.
75. The artificial urinary diversion device according to claim 71
wherein said power supply comprises primary batteries integrated
into said artificial urinary diversion device.
76. The artificial urinary diversion device according to claim 72
wherein said external recharge device is disposed in said
dislocation device.
77. The artificial urinary diversion device according to claim 76
wherein said dislocation device includes a display for indicating
said dislocation.
78. The artificial urinary diversion device according to claim 77
wherein said display includes a level indicator.
79. The artificial urinary diversion device according to claim 76
wherein said dislocation device comprises an abdominal bandage and
includes a separate control mechanism.
80. The artificial urinary diversion device according to claim 56
wherein said dislocation device is integrated into a garment.
81. The artificial urinary diversion device according to claim 77
including an ultrasonic transmitter and a receiver device for
controlling said display.
82. The artificial urinary diversion device according to claim 81
wherein said ultrasonic transmitter and receiver device includes
external Reed contacts, a Hall generator, and a charging current
unit of measurement or a power sensor.
83. The artificial urinary diversion device according to claim 56
including an actor system for executing the removal of urine from
said artificial urinary diversion device.
84. The artificial urinary diversion device according to claim 56
including at least one anti-reflux valve.
85. The artificial urinary diversion device according to claim 83
wherein said actor is controlled by an encoded signal.
86. A method for implanting the artificial urinary diversion device
of claim 56 including the steps of: (a) selecting a modular unit
which has an external contour corresponding to said artificial
urinary diversion device; (b) exchanging said modular unit for one
of said first, second or third portions to obtain a matching
implantable artificial urinary diversion device; (c) assembling
said artificial urinary diversion device in correspondence with
said modular unit; and (d) implanting said assembled artificial
urinary diversion device.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is divisional of U.S. patent application
Ser. No. 10/101,652, filed Mar. 20, 2002, which is a
continuation-in-part of U.S. patent application Ser. No.
09/936,721, filed Dec. 19, 2001, which is a 371 of PCT/EP00/02407,
filed on Mar. 17, 2000.
FIELD OF THE INVENTION
[0002] The present invention relates to an artificial urinary
diversion device. More particularly, the present invention also
relates to a suitable method for implantation of a artificial
urinary diversion device.
BACKGROUND OF THE INVENTION
[0003] Among patients with urinary bladder disorder there are a
plurality of findings which require removal of the patient's
bladder. In this situation, a urinary diversion incorporating
different types of reservoirs is generally required. So-called wet
diversions are preferred, with direct urinary diversion through the
ureters, which are implanted into the abdominal wall, or by
insertion of a neutralized part of the intestine, in which the
ureters are implanted and which is for its part implanted into the
abdominal wall.
[0004] In both cases the urine is collected in a urine bag, which
is attached to the orifice.
[0005] Alternatively, the ureters are implanted into the rectum
or--more and more in the past several years--into replacement
bladders, which are made of neutralized parts of the intestine.
[0006] These replacement bladders are either connected with the
endogenous urethra or they are conducted out by creating an
appropriate self-preserving occlusion mechanism at the abdominal
skin, for example in the navel region.
[0007] Typical indicators for a replacement of the endogenous
urinary bladder are advanced tumors of the urinary bladder, but
there are also malformations, bladder impairments due to
inflammation, as well as functional obstructions, such as for
example obstructions by urinating, or development of bladder
atrophies among paraplegics.
[0008] Thus, one of the objects of the present invention is to
create an artificial urinary diversion system and a suitable method
for implanting same which is adaptable to the different shapes of
different persons, which shows the largest possible filling volume,
and which allows for easy handling.
[0009] It is another object of the present invention to create an
artificial urinary diversion system which is highly adaptable, and
which without previous direct or indirect determination of the
potentially available volume for such a system, facilitates as
effective as possible a determination of the volume available in
the patient during surgery, and thus utilization of this device
therein.
SUMMARY OF THE INVENTION
[0010] In accordance with the present invention, these and other
objects have now been realized by the invention of an artificial
urinary diversion device containing a urinary bladder, an axial
direction, and comprising at least one first portion having a first
cross-sectional surface perpendicular to the axial direction and
including at least one outlet, a second portion having a second
cross-sectional surface perpendicular to the axial direction, and a
third portion having a third cross-sectional surface perpendicular
to the axial direction, and including at least one inlet for
accommodating the urinary bladder, the second portion being
arranged between the first portion and the third portion, the first
and second cross-sectional surfaces being smaller than the third
cross-sectional surface, and a dislocation device for sensing or
controlling the artificial urinary diversion device. Preferably,
the first, second and third portions comprise modular units,
whereby each of the first, second and third portions includes a
transitional surface permitting a continuous surface transition
between the modular units.
[0011] In accordance with one embodiment of the artificial urinary
diversion device of the present invention, the first
cross-sectional surface is larger than the second cross-sectional
surface.
[0012] In accordance with another embodiment of the artificial
urinary diversion device of the present invention, the device
includes fluid guidance means for guiding fluid from the urinary
bladder through the third portion, the second portion, and the
first portion.
[0013] In accordance with another embodiment of the artificial
urinary diversion device of the present invention, the device
includes an actuator for actuating the urinary bladder. Preferably,
the actuator comprises a pump, and the pump is preferably disposed
in the third portion. In a preferred embodiment, the pump comprises
a telescopic device, and in another embodiment, the pump comprises
a lever pump including two chambers. In yet another embodiment, the
pump comprises a screw pump. Preferably, the screw pump is disposed
in the first portion. In another embodiment, the screw pump
includes at least one screw which can be moved laterally.
[0014] In accordance with another embodiment of the artificial
urinary diversion device of the present invention, the device
includes a sphincter mechanism. Preferably, the sphincter mechanism
is disposed in the first portion.
[0015] In accordance with another embodiment of the artificial
urinary diversion device of the present invention, the dislocation
device includes control means. Preferably, the device includes a
sphincter mechanism, and the control means controls the sphincter
mechanism. In another embodiment, the device includes a pump, and
the control means controls the pump. Preferably, the device
includes secondary batteries, and the control means controls the
recharge of the secondary batteries.
[0016] In accordance with another embodiment of the artificial
urinary diversion device of the present invention, the device
includes a sensor system for monitoring the filling level of the
urinary bladder. In the preferred embodiment, the device includes
signal means whereby the sensor system produces a signal when
reaching a predetermined filling level of the urinary bladder.
Preferably, the signal comprises an audible or a vibratory signal.
Preferably, the sensor system is controlled by the nerves
responsible for natural urinary bladder control.
[0017] In accordance with another embodiment of the artificial
urinary diversion device of the present invention, the device
includes a power supply. In a preferred embodiment, the device
includes an external recharge device whereby the external recharge
device cooperates with the power supply. Preferably, the external
recharge device cooperates inductively with the power supply. In
one embodiment, the power supply comprises secondary batteries
integrated into the artificial urinary diversion device. In another
embodiment, the power supply comprises primary batteries integrated
into the artificial urinary diversion device. Preferably, the
external recharge device is disposed in the dislocation device. In
a preferred embodiment, the dislocation device includes a display
for indicating the dislocation. Preferably, the display includes a
level indicator. In a preferred embodiment, the dislocation device
comprises an abdominal bandage and includes a separate control
mechanism. In accordance with one embodiment, the dislocation
device is integrated into a garment. In another embodiment, the
apparatus includes an ultrasonic transmitter and a receiver device
for controlling the display. Preferably, the ultrasonic transmitter
and receiver device includes external Reed contacts, a Hall
generator, and a charging current unit of measurement or a power
sensor.
[0018] In accordance with another embodiment of the artificial
urinary diversion device of the present invention, the device
includes an actor system for executing the removal of urine from
the artificial urinary diversion device.
[0019] In accordance with another embodiment of the artificial
urinary diversion device of the present invention, the third
portion is divided into two parts which can be separated from each
other depending on the filling level of the urinary bladder.
[0020] In accordance with another embodiment of the artificial
urinary diversion device of the present invention, the third
portion includes either one or two inlets.
[0021] In accordance with another embodiment of the artificial
urinary diversion device of the present invention, the device
includes at least one anti-reflux valve. Preferably, the at least
one anti-reflux valve is disposed in the third portion.
[0022] In accordance with another embodiment of the artificial
urinary diversion device of the present invention, the device
includes a fixing element. In a preferred embodiment, the device
includes a dovetail joint, and the fixing element is connected with
the artificial urinary diversion device by means of the dovetail
joint. In another embodiment, the device includes guide-rail means
whereby the fixing element can be removably included and locked at
a predetermined position. Preferably, the guide-rail means is
integrated into the third portion. In another embodiment, the
fixing element comprises a splay or expanding element. In
accordance with a preferred embodiment, the fixing element is
entirely included therewithin. In another embodiment, the fixing
element is composed of a biocompatible, elastic material,
preferably silicone.
[0023] In accordance with another embodiment of the artificial
urinary diversion device of the present invention, the device
includes a first outline of a shape corresponding to a polynomial
function of 6.sup.th degree, wherein
F(x)=A+a.sub.1x+a.sub.2x.sup.2+a.sub.3x.sup.3+a.sub.4x.sup.4+a.sub.5x.sup-
.5+a.sub.6x.sup.6 in which 0<A<2; 0<a.sub.1<8;
-2<a.sub.2<0; 0<a.sub.3<1; -0,1<a.sub.4<0;
0<a.sub.5<0,003; and -0,00001<a.sub.6<0, within the
domain in which 0<x<22.
[0024] In accordance with another embodiment of the artificial
urinary diversion device of the present invention, the device
includes a second outline of a shape corresponding to a polynomial
function of 6.sup.th degree, wherein
F(x)=A+a.sub.1x+a.sub.2x.sup.2+a.sub.3x.sup.3+a.sub.4x.sup.4+a.sub.5x.sup-
.5+a.sub.6x.sup.6 in which 0<A<2; 0<a.sub.1<8;
-2<a.sub.2<0; 0<a.sub.3<1; -0,1<a.sub.4<0;
0<a.sub.5<0,003; and -0,00001<a.sub.6<0 within the
domain in which 0<x<22.
[0025] In accordance with another embodiment of the artificial
urinary diversion device of the present invention, the first,
second and third portions are formed integrally. Preferably, the
third portion includes an originating electric link to a portion of
the dislocation device which is subcutaneously implanted.
[0026] In accordance with one embodiment of the artificial urinary
diversion device of the present invention, the actor is controlled
by an encoded signal.
[0027] In accordance with the present invention, a method has also
been provided for implanting the artificial urinary diversion
device discussed above, the method including the steps of selecting
a modular unit which has an external contour corresponding to the
artificial urinary diversion device; exchanging the modular unit
for one of the first, second or third portions to obtain a matching
implantable artificial urinary diversion device; assembling the
artificial urinary diversion device in correspondence with the
modular unit; and implanting the assembled artificial urinary
diversion device.
[0028] According to the present invention, the second area, which
is arranged between the first and the third area, includes a
cross-sectional surface which is smaller than the cross-sectional
surface of the third area. In this manner, a shape is provided,
which can be adapted to almost any patient, and more particularly,
the largest possible filling volume can be provided, namely by
simultaneous consideration of various medical preconditions, such
as for example the arteries and the intestine that, after the
operation, pass laterally to the second area and on which no
pressure must be put. Attention must be paid to the fact that, with
a person who is standing erect, the third area is arranged above
the second area and the first area. For example, if the first area
shows a larger cross-sectional surface than the second area, a
so-called constriction will also be provided in the second area,
which is necessary for the bypassing arteries and/or the intestine
and the kidneys, and a positional fixing with the first area is
possible, for example, at the pubic bone (Symphysis Pubica). With
the dislocation device, according to the present invention, which
may, for example, be a device for dislocation supervision or
dislocation display, handling of the device will be eased during
permanent use thereof. By utilizing the dislocation device, on the
one hand, it is possible to indicate the position for the optimal
wireless transcutaneously transfer of performance or, on the other
hand, to describe a support when correcting the positioning in case
of an initial false placing, as each dislocation leads to a loss of
performance.
[0029] With the method according to the present invention,
implantation of an artificial urinary diversion system is provided,
which, due to the provision of an element or module which possesses
the external contour of the artificial urinary diversion system,
and which can be assembled in a modular design, protection of the
patient and of the resources is possible. Therefore, in a first
step in the operating room, a plurality of sample pieces, i.e.,
modules of the element, are assembled to an optimally suited
urinary diversion system for the patient. Thus, especially with
regards to hygiene, a method is provided which only requires
sterilization of the particular modules of the element, and not, in
the case of mismatching, modules with a highly complicated
technique inside.
[0030] If the first, second and third areas are modularly
compounded or rendered modularly compoundable, and if the
respective transition surfaces between the individual areas are
coordinated in a desired manner, a continuous transition results,
and the advantage will be achieved that, according to the
respective spatial condition of the patient, the individual areas
of the urinary diversion system can be compounded and thus, it will
be possible to take optimal account of the anatomical conditions of
the patient.
[0031] If fluid guidance means are provided, which extend from the
urinary bladder to the outlet in the first area, this corresponds
to a large extent to the natural anatomy, which means, that among a
person who is standing erect, the lowest, first area can be
connected directly with the existing urethra, without using
additional connection elements between the urethra and the outlet
in the first area, which could possibly cause further medical
complications.
[0032] If an actor or an actuator or a pump is provided in the
third area, there is then no need to provide an external pump, and,
in view of the shape selected, the first and second areas are not
negatively influenced. Furthermore, in the embodiment in which an
actuator or a pump is provided in the third area, the third area,
which is optimally embodied, can now be most likely to have the
most space for the integration of a pump without greatly or
negatively influencing the shape.
[0033] If the pump is formed as a telescope device, almost the
total volume of the third area can now be advantageously used for
filling the urinary bladder. Laboratory experiments have already
shown that almost the entire urinary bladder can be emptied with a
telescope device, without leaving any sediment in the urinary
bladder.
[0034] If the pump is formed as a lever pump, no complex mechanics
are required to be integrated therein, such as for example for the
use of a telescope device in the third area.
[0035] If the pump is formed as a screw pump, another advantage is
that almost the entire volume of the third area can now be used for
the urinary bladder. In addition, by using a screw pump, the screw
pump can pulverize possible smaller urine crystals, so that these
pulverized crystals can also be passed through a stenotic
urethra.
[0036] If additionally a screw pump is also arranged, such that it
may possibly be displaced laterally to the fluid tube or duct, an
inlet and a lavage of the artificial urinary diversion system can
now be provided without difficulty, since the fluid tube can now be
opened by moving the screw. This result concerning the inlet and
the lavage of the artificial urinary diversion system can be very
important in the field of spectroscopic examinations, for
example.
[0037] If a sphincter mechanism is preferably provided in the first
area, almost total control of the urinary continency is now
possible. The control of the sphincter mechanism can, for example,
also be initiated externally.
[0038] If, in addition, a control system is provided, which
regulates the sphincter mechanism, such a control system, which is
also able to assume further procedures, can also regulate opening
and closing of the sphincter.
[0039] If, a sensor system is provided for controlling the filling
level of the urinary bladder, the patient will be given a high
degree of safety by using the artificial urinary bladders. That is,
the patient does not have to void the urinary bladder regularly and
in short intervals, but can instead integrate with everyday life in
the usual way. If either a sound signal or a seismic signal, which
will be produced at a certain filling level of the bladder, is sent
to the concerned person, the person can operate normally in
everyday life. However, it is also noted that, if at least a
security regulation is installed in the sensor system, then, if a
certain period of time, for example 8 to 12 hours, is exceeded, the
person is signaled to void the bladder, independent of the filling
level of the bladder. Furthermore, by controlling the filling level
of the artificial bladder security is provided, which is oriented
for specific physiological marginal conditions. Thus, the
artificial urinary diversion system can operate similarly to the
function of the natural urinary bladder. Thus, with this urinary
diversion system similar to the natural process, the body first
signals the person that the urinary bladder should be emptied, then
the bladder will be opened, the urine will be pressed out or
squeezed out, and the bladder will be closed again.
[0040] If the sensor system is controlled by the nerves responsible
for the urinary bladder, an almost natural feeling will be given to
the concerned person by means of this neurological solution, and
therefore an exogenous signal, such as that produced by a sound
signal, or a seismic signal, will not be necessary.
[0041] If a power supply is additionally provided in the urinary
diversion system, a compact urinary diversion device can be
provided, which can, for example, first be integrated into the
artificial urinary diversion system. However, the power supply can
also be arranged separately, near the urinary diversion system in
the patient, if, for reasons of space, a third area must be used
which does not allow for an additional power supply.
[0042] If an external recharge device provides the power supply,
the urinary diversion system can be provided with power for almost
a lifelong period. Charging of the counterpart of the external
recharge device can be effected by the adapted counterpart, which
is charging wireless transcutaneously at an adapted main support
location, which is implanted subcutaneously.
[0043] A simple power transfer can, for example, be achieved by the
recharge device cooperating inductively with its counterpart, with
power being transferred inductively at frequencies which are
tolerated by the body, for example 30 kHz.
[0044] If the power supply is composed of secondary batteries, the
urinary diversion system will optimally cooperate with the recharge
device.
[0045] If the power supply is comprised of primary batteries, which
are integrated into the urinary diversion device, the urinary
diversion device will work without any continuing maintenance and
the person concerned does not have to worry about the power
supply.
[0046] If the dislocation unit is integrated into the recharge
device, handling is simplified and, when the recharge device is out
of place, such false placement will be documented. This is quite
important, because, in case of inductive, capacitive or other
wireless transmission of performance data from the outside into the
human body, the external and internal transmitter components must
be optimally led together in the appropriate position. In this
manner, direct positioning can be shown digitally by means of a
yes/no display or an optimal/non-correct display.
[0047] If the dislocation unit includes a display unit for
indicating dislocation, preferably a level display, the extent of
longitudinal dislocation and the extent of rotational dislocation,
particularly by means of a level display, are shown.
[0048] If the dislocation unit is developed as an abdominal bandage
with a separate operating element, a compact system is provided,
which can be worn partially invisibly and permanently correctly
positioned.
[0049] If the dislocation unit is integrated into a garment, the
user can comply with his habits, without being visibly singled
out.
[0050] Identification of improper positioning can be effected
alternatively, or it can be combined by means of an ultrasonic
transmitter and receiver with an attaching telemetric data-signal
transmission from the body, or an external reed contact, which
react with a subcutaneously implanted magnetic field of, for
example, at least two permanent magnets, or by means of a Hall
generator or an agitated Hall sensor, which reacts with implanted
magnetic or field-producing components, or by means of a
charging-current measurement, whose correct positioning of the
transmission media results in a maximum charging current, as
lateral deviations in any direction and in rotation diminish the
ideal position of the charging current, whereby by measuring and
indicating the charging current correct positioning can be
determined, or this can be done by means of a current sensor.
[0051] If an actor system is also integrated into the urinary
diversion device, once again a completely independent system can be
provided, which only needs to be connected at the inlets or outlets
with functional structures of the patient's urinary diversion
system, and which can be implanted as one compact part.
[0052] It is also pointed out that where necessary the power for
the actor system and/or the sensor system can be transferred
wirelessly transcutaneously by placing a suitable transfer device
onto the skin. However, it is also necessary in that case that
controlling and providing can also be executed by primary batteries
as an additional power source. It is also possible that the total
control and sensor system can be interrogated, and initiated
externally telemetrically.
[0053] If the third area is constructed bipartite or in two-part
form and dependent on the filling level of the urinary bladder, one
part is able to move away from the other part, it is also possible
to flexibly adjust the size of the urinary bladder and the filling
level, in accordance with the patient's requirements.
[0054] If the urinary diversion device includes two inlets in the
third area, so that each ureter can be connected with the
artificial urinary diversion system, it will not be necessary to
provide a further separate additional element, for example in a
Y-shape, which can be used if it is advantageous that the urinary
diversion device only has one inlet.
[0055] By providing one or more anti-reflux valves in the third
area, reflux of the urine into the kidney can be stopped. This also
prevents possible ascent of bacteria from the bladder up to the
kidney.
[0056] If a fixing element is provided, it is then easy to arrange
and fix it in the human body.
[0057] If the fixing element is connected with the urinary
diversion device by means of a dovetail joint, a tight or
leak-proof connection can be constructed, and the fixing element
can be retained in the body, in order to be later connected at the
right place with the urinary diversion device.
[0058] If the fixing element is movably fixed by means of a
guidance system, the urinary diversion device can, according to the
anatomy of the person concerned, be optimally arranged and fixed.
If the guide-rail system is also integrated into the third area,
there are no rails available that are protruding from the third
area, which could possibly adversely influence arrangement in the
human body, or cause any functional or spatial inconvenience.
[0059] If the fixing element includes a splay or expanding element,
which may, for example, widen after implanting into the guide
rails, the possibility of a simple connection is provided,
guarantying a particular compatibility by the complete integration
of the splay element into the fixing element.
[0060] If the fixing element is formed with a biocompatible
material, such as silicone, a well-tolerated material is provided,
and in addition the elasticity of the silicone and other such
materials are utilized due to the splay movements of the splay
element.
[0061] If the actor is controlled by an encoded signal, a
malfunction of different artificial urinary diversion systems is
impossible, thus avoiding any unintentional voiding of different
artificial urinary diversion systems.
BRIEF DESCRIPTION OF THE DRAWINGS
[0062] Referring to the following detailed description, which
refers to the drawings, the artificial urinary diversion system of
the present invention is described in detail, as follows:
[0063] FIG. 1 is a side, perspective, schematic view of the
artificial urinary diversion system of the present invention;
[0064] FIG. 2 is side, elevational, a sectional view of the
artificial urinary diversion system shown in FIG. 1, taken along
line II-II thereof;
[0065] FIG. 3 is a top, elevational, view of the urinary diversion
system shown in FIG. 1;
[0066] FIG. 4 is a bottom, elevational view of the urinary
diversion system shown in FIG. 1;
[0067] FIG. 5 is a side, perspective, fragmented view of the
urinary diversion system shown in FIG. 1 separated into single
areas;
[0068] FIG. 6 is a side, elevational, sectional view of the
arrangement of the urinary diversion system of the present
invention in a human body;
[0069] FIG. 7 is a front, elevational view of the urinary diversion
system shown in FIG. 6;
[0070] FIG. 8 is a top, elevational view of the urinary diversion
system shown in FIG. 7, taken along line VII-VII thereof;
[0071] FIG. 9 is a graphical representation showing one executed
polynomial function of 6.sup.th degree regarding the top surface
outline of the urinary diversion system in accordance with FIG.
1;
[0072] FIG. 10 is a graphical representation showing the top-view
silhouette of the urinary diversion system shown in FIG. 1,
relating to the polynomial function of 6.sup.th degree referred to
in FIG. 9;
[0073] FIG. 11 is a side, elevational, schematic view of an
embodiment of the fixing element used in accordance with the
present invention;
[0074] FIG. 12 is a schematic view of the dislocation unit of the
present invention; and;
[0075] FIG. 13 is a side, perspective view of one embodiment of the
dislocation unit of the present invention.
DETAILED DESCRIPTION
[0076] A preferred embodiment of the urinary diversion system
explained in FIG. 1 includes a first area A, a second area B and a
third area C, with the cross-sectional surfaces (illustrated
hatched) that are perpendicular to the axial alignment of the
urinary diversion device of the first, second and third areas,
being constructed such that the cross-sectional surface Q1 of the
first area A is larger than the cross-sectional surface Q2 of the
second area B and the cross-sectional surface Q3 of the third area
C is in each case larger than the cross-sectional surfaces of the
first and second areas. In addition, the first area A includes an
outlet 3 and the third area C includes two inlets 5 for the
urethras, which come from the respective kidneys.
[0077] The first area A of the urinary diversion system includes at
its bottom surface 7 an increasing area D, with the shape possibly
being linear, arched, concave or convex, dependent upon the
patient's anatomical conditions for the urinary diversion system
hereof. In FIG. 1 it can clearly be seen that the second area B,
which is arranged between the first area and the third area, is to
be regarded as a constriction, with arteries being led by laterally
to its surfaces 9. The third area C, which comprises a urinary
bladder, is shaped voluminously enough to allow for filling as much
as possible. The two inlets for the renal urethra are provided at
the front side of the third area.
[0078] FIG. 2 illustrates a lateral sectional view according to
intersection II-II of FIG. 1. With this sectional view it can
clearly be seen that the urinary diversion device 1 presented in
FIG. 2 shows the top-side of a first outline K1. Here, in contrast
to FIG. 1, the elevation of the second area B to the bottom surface
7 of the first area A is more clearly seen. In this embodiment, a
curved or curvilinear elevation is shown. This curved elevation
serves to be brought into contact, for example, with the pubic bone
and thus makes positional fixing possible. It can also be seen in
FIG. 2 that below the third area so-called guide rails 13 are
provided, in which a fixing element (not shown) can be inserted. At
this point, special attention should be drawn to the fact that a
protruding of the guide rails may, for example, be avoided by
complete integration into the third area.
[0079] FIG. 3 illustrates a top view of the urinary diversion
system 1 and a second outline K2 in accordance with FIG. 1, with
the constriction caused by the second area B being clearly visible,
such that the arteries can be led by laterally of the side surfaces
9. The relative proportions, which are shown between the first, the
second and the third area, are also clearly visible.
[0080] FIG. 4 shows a bottom view of the urinary diversion system
1. The provided guide rails 13 for the fixing element are clearly
indicated.
[0081] FIG. 5 illustrates the urinary diversion system 1, with its
individual areas, i.e. first, second and third area, illustrated
separately.
[0082] At this point it should be noted that the division or
sectioning into a first area, a second area and a third area sets
forth a preferred embodiment hereof. The urinary diversion system
can also be provided with only two areas or as an integral entity.
On the other hand, it is also possible to provide more than three
areas, which can be divided separately with more areas of the
increased adapting variation being taken into account.
[0083] FIG. 6 illustrates, for example, arranging of the urinary
diversion system. The first area A borders on the pubic bone, with
the fixing element, which is moveably includable in the guide
rails, being fixed, for example, at the respective places in the
abdominal cavity.
[0084] FIG. 7 shows a front view for further illustration of
arranging of the urinary diversion system hereof.
[0085] FIG. 8 is a top view, with the body section being above the
section of said urinary diversion system.
[0086] FIG. 9 is, for example, a fit curve of the polynomial form
f(x)=a.sub.6x.sup.6+a.sub.5x+a.sub.4x.sup.4+a.sub.3x.sup.3+a.sub.2x.sup.2-
+a.sub.1x+a, i.e., a polynomial of 6.sup.th degree, which has been
adapted to the first outline. The parameters used for this
adaptation are a.sub.6=-910.sup.6; a.sub.5=0,006; a.sub.4=-0,014;
a.sub.3=0,1638; a.sub.2=-0,9319; a.sub.1=2,6778 and a=0,8452.
However, it turned out that within a domain of
0.ltoreq.X.ltoreq.22, the coefficients a.sub.1 to a.sub.6 in the
domains 0<A<2; 0<a.sub.1<8; -2<a.sub.2<0;
0<a.sub.3<1; -0,1<a.sub.4<0; 0<a.sub.5<0,003 and
-0,00001<a.sub.6<0 within a domain of 0<x<22 can be
taken.
[0087] FIG. 10 illustrates a top view of the half of a second
outline, which has also been approximated with a polynomial of
6.sup.th degree. The parameters used for this were
a.sub.6=110.sup.-5; a.sub.5=0,008; a.sub.4=-0,0198; a.sub.3=0,221;
a.sub.2=-1,2703; a.sub.1=3,9521 and A=1,2557. It has also been
determined that these coefficients can also be taken in the domains
0<A<2; 0<a.sub.1<8; -2<a.sub.2<0;
0<a.sub.3<1; -0,1<a.sub.4<0; 0<a.sub.5<0,003; and
-0,00001<a.sub.6<0 within a domain of 0<x<22, for
adapting the respective second outline. To illustrate that FIG. 10
is a top view, the first outline and the fitted curve have been
reflected at y=0 at the x-axis of the diagram.
[0088] FIG. 11 illustrates a fixing element 15 with a front area F,
which can be introduced into the guide rails of the urinary
diversion system, and an end area E, which can, for example, be
pressed by hand.
[0089] Inside of the fixing element 15 there is a splay element
(illustrated dashed), which is, due to the upright side surfaces
19A to 19D, taken along with the elastically formed fixing element
15 so that, for example, when impacting on the end area, the arms
of the splay element 17 in the front area also move towards each
other, and take the elastic material of the fixing element 15 with
them.
[0090] Thus, the fixing element 15 can be narrowed such that it can
be included between the two guide rails 13. After introduction, the
fixing element 15 will be released, so that, due to the elasticity
of fixing element 15, the front area F will return to its original
shape, and a press fit/tight fit may be achieved with the side
surfaces of the guide rails. If the fixing element 15 shall now be
moved within the guide rail 13, it is only necessary to re-press or
re-contract the end area E, in order to open the press fit of the
side surfaces of the front area F. The slots or openings 21 in the
fixing element 13 serve for being tightly led by the guide rails
when the position of the fixing element is to be re-aligned.
[0091] Thus, with this fixing element 15 the urinary diversion
device can be suitably arranged before its final arranging and the
fixing element can be fixed at the corresponding position in the
abdominal cavity.
[0092] Due to this additional provision, which is providing a
fixing element that is separate from the urinary diversion system,
it is also possible to pre-fix the fixing element at places
difficult to access for fixing a fixing element, and to then
introduce it into the urinary diversion device.
[0093] Instead of the screw pump, the pump using a telescope
device, and the lever pump, all other types of pumps are imaginable
for squeezing the urine, particularly a membrane pump or a gear
pump.
[0094] The cross-sectional surfaces Q1, Q2 and Q3 can be different
geometrical surfaces, such as quadratic, rectangular, trapezoidal,
round, oval, elliptical or any other combination thereof.
[0095] Exemplary for the block diagram, FIG. 12 shows electrical
circuitry for the urinary diversion system with an external
recharge unit and a dislocation unit. On the left side of the
separating line A, the components of the recharge unit of the
external power supply or of the dislocation unit are illustrated.
On the right side of the separating line A, the components, which
are linked to or integrated into the urinary diversion device are
shown. In this embodiment, display of the dislocation is effected
by an electronic evaluation of the Hall sensors, which are
connected with the charging connection by means of a subcutaneous
coil. The display of the charge status can, if possible, be
effected optically or acoustically. The subcutaneously arranged
components contain a charging connection, which is connected to the
accumulator, when it is signalized by means of a control system
signaling that the voltage has, for example, decreased for more
than 6 volts, or it is signalized by means of a separate
charge-status signal that the charging shall be effected. The
charging connection is connected with a data-sender provider, which
can, for example, indicate by means of the charging current if a
dislocation is present. The control system particularly controls
the status, when the consumer requires energy.
[0096] FIG. 13 shows an embodiment of a dislocation unit as an
abdominal bandage with separate control, with the control
containing a display for the longitudinal dislocation and for
example a display for the rotational dislocation, preferably a
level indicator. Basically, the control contains a longitudinal and
rotational mobility possibility, which is relative to the fixing
element, in this case a belt, in order to optimally position the
dislocation unit. Furthermore, the control contains interrogation
keys, by means of which it is possible to interrogate the recent
operating state of the subcutaneously contained component.
Furthermore, there is an LED display for the interrogation keys,
with additional fix display modes being able to be made by means of
the LED display.
[0097] Finally, concerning the spectroscopic examinations, it is
noted that for the urinary diversion system, an emergency supply
must be provided among all solutions of pumps, valves and anti-fix
valves. This means that all artificial system components, such as
valves, pumps, etc. have to be opened easily and to be easily
movable or evadable. With this measure, the urinary diversion
system will meet current medical standards.
[0098] Although the invention herein has been described with
reference to particular embodiments, it is to be understood that
these embodiments are merely illustrative of the principles and
applications of the present invention. It is therefore to be
understood that numerous modifications may be made to the
illustrative embodiments and that other arrangements may be devised
without departing from the spirit and scope of the present
invention as defined by the appended claims.
* * * * *