U.S. patent application number 10/203085 was filed with the patent office on 2003-07-03 for impotence treatment apparatus with energy transforming means.
Invention is credited to Peter, Forsell.
Application Number | 20030125768 10/203085 |
Document ID | / |
Family ID | 26877787 |
Filed Date | 2003-07-03 |
United States Patent
Application |
20030125768 |
Kind Code |
A1 |
Peter, Forsell |
July 3, 2003 |
Impotence treatment apparatus with energy transforming means
Abstract
A male sexual impotence treatment apparatus includes or use an
operable restriction device implantable in a male patient for
engaging a tissue portion of the penile tissue to form a
restrictable passageway for the penile exit blood flow. An energy
transmission device is provided for wireless transmission of energy
from outside the patient's body to inside the patient's body for
use in connection with the operation of the restriction device,
including temporarily contracting said tissue portion to restrict
the penile exit blood flow in the blood flow passageway to achieve
erection.
Inventors: |
Peter, Forsell; (Zug,
CH) |
Correspondence
Address: |
Nixon & Vanderhye
8th Floor
1100 North Glebe Road
Arlington
VA
22201-4714
US
|
Family ID: |
26877787 |
Appl. No.: |
10/203085 |
Filed: |
November 19, 2002 |
PCT Filed: |
February 9, 2001 |
PCT NO: |
PCT/SE01/00268 |
Current U.S.
Class: |
607/2 |
Current CPC
Class: |
A61F 5/41 20130101 |
Class at
Publication: |
607/2 |
International
Class: |
A61N 001/00 |
Claims
1. A male sexual impotence treatment apparatus, comprising an
operable restriction device implantable in an impotent patient for
engaging a tissue portion of the normal penile tissue or the
prolongation thereof to form a restrictable penile exit blood flow
passageway, characterised by an energy transmission device for
wireless transmission of energy from outside the patient's body to
inside the patient's body for use in connection with the operation
of the restriction device, including temporarily contracting said
tissue portion to restrict the penile exit blood flow in the blood
flow passageway to achieve erection.
2. An apparatus according to claim 1, wherein the energy
transmission device transmits energy of a first form and the
restriction device is operable in response to energy of a second
form, and further comprising an energy transforming device
implantable in the patient for transforming the energy of the first
form wirelessly transmitted by the energy transmission device into
the energy of the second form.
3. An apparatus according to claim 2, wherein the energy of the
second form is different than the energy of the first form.
4. An apparatus according to claim 2 or 3, wherein the energy
transforming device comprises at least one element having a
positive region and a negative region, the element is capable of
creating an energy field between the positive and negative regions
when exposed to the energy of the first form transmitted by the
energy transmission device, and the energy field produces the
energy of the second form.
5. An apparatus according to claim 4, wherein the element comprises
an electrical junction element, and the electrical junction element
is capable of inducing an electric field between the positive and
negative regions when exposed to the energy of the first form
transmitted by the energy transmission device, whereby the energy
of the second form comprises electric energy.
6. An apparatus according to claim 5, wherein the restriction
device is electrically operated, and the positive and negative
regions of the electrical junction element supply electric energy
for the operation of the restriction device.
7. An apparatus according to claim 6, further comprising electric
conductors connected to the positive and negative regions of the
electrical junction element, whereby the electrical junction
element is capable of supplying an electric current via the
conductors.
8. An apparatus according to claim 7, wherein the electrical
junction element is capable of supplying a direct current or
pulsating direct current via the conductors.
9. An apparatus according to claim 7, wherein the electrical
junction element is capable of supplying an alternating current or
a combination of a direct and alternating current via the
conductors.
10. An apparatus according to claim 6, wherein the electrical
junction element is capable of supplying a frequency or amplitude
modulated signal.
11. An apparatus according to claim 6, wherein the electrical
junction element is capable of supplying an analog or digital
signal.
12. An apparatus according to any of claims 2-11, wherein the
energy transforming device forms a flat and thin sheet, and has a
volume of less than 2000 cm.sup.3.
13. An apparatus according to claim 2 or 3, wherein the energy
transforming device is adapted to transform the energy of the first
form directly or indirectly into the energy of the second form.
14. An apparatus according to claim 13, further comprising an
implantable motor or pump for operating the restriction device,
wherein the motor or pump is powered by the energy of the second
form.
15. An apparatus according to claim 14, wherein the energy
transforming device is adapted to directly power the motor or pump
by the transformed energy, as the energy of the second form is
being transformed from the energy of the first form.
16. An apparatus according to any of claims 13-15, wherein the
wireless energy of the first form comprises sound waves and the
energy of the second form comprises electric energy.
17. An apparatus according to any of claims 2-16, wherein the
energy transforming device comprises a capacitor and the energy of
the second form comprises electric energy.
18. An apparatus according to claim 17, wherein the capacitor is
adapted to produce electric pulses from the transformed electric
energy.
19. An apparatus according to claim 18, wherein the capacitor is
adapted to produce the pulses of the electric energy, as the energy
transforming device transforms the energy of the first form
transmitted by the energy transmission device into the electric
energy of the second form.
20. An apparatus according to claim 2, further comprising an
implantable stabiliser for stabilising the energy of the second
form.
21. An apparatus according to claim 20, wherein the energy of the
second form comprises electric current and the stabiliser comprises
at least one capacitor.
22. An apparatus according to any of the preceding claims, further
comprising implantable electrical components including at least one
voltage level guard.
23. An apparatus according to any of claims 1-21, further
comprising implantable electrical components including a single
voltage level guard.
24. An apparatus according to claim 22 or 23, wherein the
electrical components are devoid of any current detector and/or
charge level detector.
25. An apparatus according to any of claims 22-24, further
comprising an implantable capacitor or accumulator, wherein the
charge or discharge of the capacitor or accumulator is controlled
by use of the voltage level guard.
26. An apparatus according to any of claims 17-19,21 and 25,
wherein the capacitor has a capacity less than 0,1 .mu.F.
27. An apparatus according to claim 1, wherein the energy
transmission device is adapted to transmit wireless energy for
direct use in connection with the operation of the restriction
device, as the wireless energy is being transmitted.
28. An apparatus according to claim 27, further comprising an
implantable motor or pump for operating the restriction device,
wherein the energy transmission device is adapted to directly power
the motor or pump with wireless energy.
29. An apparatus according to claim 28, wherein the energy
transmission device is adapted to transmit wireless energy in the
form of a magnetic field or electromagnetic waves for direct power
of the motor or pump
30. An apparatus according to claim 2, wherein the energy
transforming device is adapted to supply the energy of the second
form for direct use in connection with the operation of the
restriction device, as the energy of the first form is being
transformed into the energy of the second form.
31. An apparatus according to claim 30, further comprising an
implantable motor or pump for operating the restriction device,
wherein the energy transforming device is adapted to directly power
the motor or pump with the energy of the second form.
32. An apparatus according to claim 31, wherein the energy
transforming device directly operates the restriction device with
the energy of the second form in a non-magnetic, non-thermal or
non-mechanical manner.
33. An apparatus according to any of claims 2-12, further
comprising an implantable motor for direct or intermittent
operation of the restriction device, wherein the energy
transforming device powers the motor with the energy of the second
form.
34. An apparatus according to claim 33, wherein the restriction
device is operable to perform a reversible function and the motor
is capable of reversing said function.
35. An apparatus according to any of claims 2-27 and 30, wherein
the restriction device comprises a hydraulic restriction device,
and further comprising an implantable pump for operating the
hydraulic restriction device, the energy transforming device
supplying the energy of the second form for driving the pump.
36. An apparatus according to any of claims 28,29,31 and 35,
wherein the pump is not a plunger type of pump.
37. An apparatus according to any of the preceding claims, wherein
the energy transforming device is capable of generating as the
energy of the second form a current exceeding 1 .mu.A, when
transferring the energy of the first form transmitted by the energy
transmission device.
38. An apparatus according to any of the preceding claims, further
comprising an adjustment device for adjusting the restriction
device to change the restriction of the blood flow passageway,
wherein the adjustment device is adapted to mechanically adjust the
restriction device, or adapted to hydraulically adjust the
restriction device by using hydraulic means which is devoid of
hydraulic fluid of the kind having a viscosity that substantially
increases when exposed to heat or a magnetic field.
39. An apparatus according to any of claims 2-12, wherein the
energy transforming device comprises at least one semiconductor
type of component.
40. An apparatus according to claim 39, wherein the energy
transforming device comprises a circuitry of semiconductor
components.
41. An apparatus according to claim 39, wherein the semiconductor
component comprises a transistor or microchip or similar electronic
components excluding rectifying diodes.
42. An apparatus according to claim 40 or 41, wherein the
semiconductor component comprises at least one element having a
positive region and a negative region, the element is capable of
creating an energy field between the positive and negative regions
when exposed to the energy of the first form transmitted by the
energy transmission device, and the energy field produces the
energy of the second form.
43. An apparatus according to any of the preceding claims, further
comprising an implantable operation device for operating the
restriction device, wherein the energy transforming device powers
the operation device with the energy of the second form.
44. An apparatus according to claim 43, further comprising a
control device for controlling the operation device.
45. An apparatus according to claim 43 or 44, wherein the operation
device comprises a motor.
46. An apparatus according to claim 33 or 45, further comprising an
implantable gearing connected to the motor.
47. An apparatus according to claims 44 and 45, wherein the motor
comprises a rotary motor and the control device controls the rotary
motor to rotate a desired number of revolutions.
48. An apparatus according to claim 45, wherein the motor comprises
a linear motor.
49. An apparatus according to claim 44 and 45, wherein the motor
comprises a hydraulic or pneumatic fluid motor, and the control
device controls the fluid motor.
50. An apparatus according to claim 45, wherein the motor comprises
an electric motor having electrically conductive parts made of
plastics.
51. An apparatus according to claim 43, wherein the restriction
device comprises hydraulic means and the operation device is
adapted to conduct a hydraulic fluid in the hydraulic means.
52. An apparatus according to claim 51, wherein the operation
device comprises a fluid conduit connected to the hydraulic means
of the restriction device, and a reservoir for fluid, the reservoir
forming part of the conduit.
53. An apparatus according to claim 52, wherein the hydraulic means
and conduit are devoid of any non-return valve.
54. An apparatus according to claim 53, wherein the reservoir forms
a fluid chamber with a variable volume, and the operation device is
adapted to distribute fluid from the chamber to the hydraulic means
of the restriction device by reduction of the volume of the chamber
and to withdraw fluid from the hydraulic means to the chamber by
expansion of the volume of the chamber.
55. An apparatus according to claim 54, wherein the operation
device comprises an implantable motor used for reducing and
expanding the volume of the chamber.
56. An apparatus according to any of claims 51-53, wherein the
operation device comprises an implantable pump for pumping the
hydraulic fluid in the hydraulic means of the restriction
device.
57. An apparatus according to claim 44, wherein the control device
shifts polarity of the energy of the second form to reverse the
operation device.
58. An apparatus according to claim 45 or 57, wherein the operation
device comprises an electric motor and the energy of the second
form comprises electric energy.
59. An apparatus according to any of claims 1,43 and 44, wherein
the restriction device is operable to perform a reversible
function.
60. An apparatus according to claim 59, further comprising a
reversing device implantable in the patient for reversing the
function performed by the restriction device.
61. An apparatus according to claims 44 and 60, wherein the control
device controls the reversing device to reverse the function
performed by the restriction device.
62. An apparatus according to claim 60 or 61, wherein the reversing
device comprises hydraulic means including a valve for shifting the
flow direction of a fluid flow in the hydraulic means.
63. An apparatus according to claim 60 or 61, wherein the reversing
device comprises a mechanical reversing device.
64. An apparatus according to claim 63, wherein the reversing
device comprises a gearbox.
65. An apparatus according to claim 60 or 61, wherein the reversing
device comprises a switch.
66. An apparatus according to claim 65, wherein the switch is
operable by the energy of the second form.
67. An apparatus according to claim 66, wherein the control device
controls the operation of the switch by shifting polarity of the
energy of the second form.
68. An apparatus according to claim 66 or 67, wherein the switch
comprises an electric switch and the energy of the second form
comprises electric energy.
69. An apparatus according to claim 43, wherein the operation
device comprises hydraulic means and at least one valve for
controlling a fluid flow in the hydraulic means.
70. An apparatus according to claim 69, further comprising a
wireless remote control for controlling the valve.
71. An apparatus according to any one of claims 18,19 and 44,
wherein the control device is adapted to control the energy
transforming device to produce the energy of the second form in a
train of energy pulses for direct use in connection with the
operation of the restriction device.
72. An apparatus according to claim 2, further comprising an energy
storage device implantable in the patient for storing the energy of
the second form and for supplying energy in connection with the
operation of the restriction device.
73. An apparatus according to claim 72, wherein the energy storage
device comprises an accumulator.
74. An apparatus according to claim 73, wherein the energy of the
second form comprises electric energy and the energy storage device
comprises an electric accumulator.
75. An apparatus according to claim 74, wherein the electric
accumulator comprises at least one capacitor or at least one
rechargeable battery, or a combination of at least one capacitor
and at least one rechargeable battery.
76. An apparatus according to any of claims 2,65,71-75, further
comprising a switch implantable in the patient for directly or
indirectly switching the operation of the restriction device.
77. An apparatus according to claim 76, further comprising a source
of energy implantable in the patient, wherein the switch is
operated by the energy of the second form supplied by the energy
storage device to switch from an off mode, in which the source of
energy is not in use, to an on mode, in which the source of energy
supplies energy for the operation of the restriction device.
78. An apparatus according to claim 76, further comprising a source
of energy implantable in the patient, and a remote control for
controlling the supply of energy of the source of energy, wherein
the switch is operated by the energy of the second form supplied by
the energy storage device to switch from an off mode, in which the
remote control is prevented from controlling the source of energy
and the source of energy is not in use, to a standby mode, in which
the remote control is permitted to control the source of energy to
supply energy for the operation of the restriction device.
79. An apparatus according to claim 76, further comprising a source
of energy implantable in the patient for supplying energy for the
operation of the restriction device, wherein the switch is operated
by the energy of the second form supplied by the energy
transforming device to switch from an off mode, in which the source
of energy is not in use, to an on mode, in which the source of
energy supplies energy for the operation of the restriction
device.
80. An apparatus according to claim 76, further comprising a source
of energy implantable in the patient for supplying energy for the
operation of the restriction device, and a remote control for
controlling the supply of energy of the implantable source of
energy, wherein the switch is operated by the energy of the second
form supplied by the energy transforming device to switch from an
off mode, in which the remote control is prevented from controlling
the source of energy and the source of energy is not in use, to a
standby mode, in which the remote control is permitted to control
the source of energy to supply energy for the operation of the
restriction device.
81. An apparatus according to claim 76, further comprising a source
of energy implantable in the patient for supplying energy for the
operation of the restriction device, wherein the switch is operated
by the energy of the first form supplied by the energy transmission
device to switch from an off mode, in which the source of energy is
not in use, to an on mode, in which the source of energy supplies
energy for the operation of the restriction device.
82. An apparatus according to claim 76, further comprising a source
of energy implantable in the patient for supplying energy for the
operation of the restriction device, and a remote control for
controlling the supply of energy of the implantable source of
energy, wherein the switch is operated by the energy of the first
form supplied by the energy transmission device to switch from an
off mode, in which the remote control is prevented from controlling
the source of energy and the source of energy is not in use, to a
standby mode, in which the remote control is permitted to control
the source of energy to supply energy for the operation of the
restriction device.
83. An apparatus according to claim 2, wherein the restriction
device is electrically operated, and the energy of the second form
comprises electric energy.
84. An apparatus according to claim 83, further comprising electric
conductors connected to the energy transforming device, whereby the
energy transforming device is capable of supplying an electric
current via the conductors.
85. An apparatus according to claim 2, wherein the energy
transforming device is capable of supplying a frequency, amplitude
or frequency and amplitude modulated signal.
86. An apparatus according to claim 2, wherein the energy
transforming device is capable of supplying an analog, digital or a
combination of an analog and digital signal.
87. An apparatus according to claim 1, further comprising an
activatable source of energy implantable in the patient, wherein
the source of energy is activated by wireless energy transmitted by
the energy transmission device, to supply energy which is used in
connection with the operation of the restriction device.
88. An apparatus according to claim 1, wherein the energy
transmission device transmits energy by at least one wireless
signal.
89. An apparatus according to claim 88, wherein the signal contains
radiant energy.
90. An apparatus according to claim 88, wherein the signal
comprises a wave signal.
91. An apparatus according to claim 90, wherein the wave signal
comprises an electromagnetic wave signal including one of an
infrared light signal, a visible light signal, an ultra violet
light signal, a laser signal, a micro wave signal, a radio wave
signal, an x-ray radiation signal, and a gamma radiation
signal.
92. An apparatus according to claim 90, wherein the wave signal
comprises a sound or ultrasound wave signal.
93. An apparatus according to any one of claims 88-92, wherein the
signal comprises a digital or analog signal, or a combination of a
digital and analog signal.
94. An apparatus according to claim 2, wherein the energy of the
first form transmitted by the energy transmission device comprises
an electric, an electromagnetic or a magnetic field, or a
combination thereof.
95. An apparatus according to claim 94, wherein the electric,
electromagnetic or magnetic field, or the combination thereof is
transmitted in pulses or digital pulses, or a combination of pulses
and digital pulses by the energy transmission device.
96. An apparatus according to claim 2, wherein the energy of a
first form transmitted by the energy transmission device comprises
an electric, an electromagnetic or a magnetic field, or a
combination thereof.
97. An apparatus according to claim 96, wherein the electric,
electromagnetic or magnetic field, or the combination thereof is
transmitted in waves or analog pulses or a combination thereof by
the energy transmission device.
98. An apparatus according to any one of claims 1-97, wherein the
energy transmitted by the energy transmission device comprises
polarised energy.
99. An apparatus according to claim 2, wherein the energy
transforming device transforms the energy of the first form into a
direct current or pulsating direct current, or a combination of a
direct current and pulsating direct current.
100. An apparatus according to claim 2, wherein the energy
transforming device transforms the energy of the first form into an
alternating current or a combination of a direct and alternating
current.
101. An apparatus according to claim 2, further comprising an
implantable pulse generator for generating electrical pulses from
the energy of the second form produced by the energy field.
102. An apparatus according to any one of the preceding claims,
further comprising at least one implantable sensor for sensing at
least one physical parameter of the patient.
103. An apparatus according to claim 102, wherein the sensor
comprises a pressure sensor for directly or indirectly sensing as
the physical parameter the pressure in the blood flow
passageway.
104. An apparatus according to claim 102, further comprising a
control device for controlling the restriction device in response
to signals from the sensor.
105. An apparatus according to claim 104, wherein the control
device comprises an internal control unit implantable in the
patient for controlling the restriction device in response to
signals from the sensor.
106. An apparatus according to claim 105, wherein the internal
control unit directly controls the restriction device in response
to signals from the sensor.
107. An apparatus according to claim 104, wherein the control
device comprises an external control unit outside the patient's
body for controlling the restriction device in response to signals
from the sensor.
108. An apparatus according to claim 107, wherein the external
control unit stores information on the physical parameter sensed by
the sensor and is manually operated to control the restriction
device based on the stored information.
109. An apparatus according to any one of claims 102-108, further
comprising at least one implantable sender for sending information
on the physical parameter sensed by the sensor.
110. An apparatus according to any one of the preceding claims,
further comprising a wireless remote control for transmitting at
least one wireless control signal for controlling the restriction
device.
111. An apparatus according to claim 110, wherein the control
signal comprises a frequency, amplitude or frequency or amplitude
modulated signal.
112. An apparatus according to claim 110, wherein the control
signal comprises an analog or a digital signal, or a combination of
an analog and digital signal.
113. An apparatus according to any of claims 110-112, wherein the
remote control is capable of obtaining information on the condition
of the implantable restriction device and to control the
restriction device in response to the information.
114. An apparatus according to any of claims 110-113, wherein the
remote control comprises an implantable control unit for
controlling the restriction device.
115. An apparatus according to claim 114, wherein the control unit
comprises a microprocessor.
116. An apparatus according to any one of claims 110-115, wherein
the wireless remote control comprises at least one external signal
transmitter or transceiver and at least one internal signal
receiver or transceiver implantable in the patient.
117. An apparatus according to any one of claims 110-115, wherein
the wireless remote control comprises at least one external signal
receiver or transceiver and at least one internal signal
transmitter or transceiver implantable in the patient.
118. An apparatus according to any one of claims 110-117, wherein
the remote control is capable of sending information related to the
restriction device from inside the patients body to the outside
thereof.
119. An apparatus according to claim 118, wherein the remote
control controls the restriction device in response to the
information.
120. An apparatus according to any one of claims 110-119, wherein
the remote control comprises a control signal transmitter for
transmitting the wireless control signal, and the energy
transmission device comprises the control signal transmitter,
whereby energy is transmitted by the control signal.
121. An apparatus according to any one of claims 110-119, wherein
the energy transmission device transmits energy by at least one
signal separate from the control signal.
122. An apparatus according to any one of claims 110-119, wherein
the remote control transmits a carrier signal for carrying the
control signal.
123. An apparatus according to any one of claims 110-119, wherein
the energy transmission device transmits energy by at least one
signal, which is used as a carrier signal for the control signal
transmitted by the remote control.
124. An apparatus according to claim 123, wherein the carrier
signal is frequency, amplitude or frequency and amplitude
modulated.
125. An apparatus according to claim 123 or 124, wherein the
carrier signal comprises digital, analog or a combination of
digital and analog signals.
126. An apparatus according to claim 125, wherein the signals
comprise wave signals.
127. An apparatus according to any one of claims 110-126, wherein
the control signal comprises a wave signal comprising one of a
sound wave signal, an ultrasound wave signal, an electromagnetic
wave signal, an infrared light signal, a visible light signal, an
ultra violet light signal, a laser light signal, a micro wave
signal, a radio wave signal, an x-ray radiation signal and a gamma
radiation signal.
128. An apparatus according to any one of claims 110-126. wherein
the control signal comprises an electric or magnetic field, or a
combined electric and magnetic field.
129. An apparatus according to claim 112, wherein the remote
control transmits an electromagnetic carrier wave signal for
carrying the digital or analog control signal.
130. An apparatus according to claim 2, wherein the energy of the
second form used for operating the restriction device is wirelessly
transmitted by the energy transforming device.
131. An apparatus according to claim 1, further comprising an
implantable control unit for controlling the restriction
device.
132. An apparatus according to claim 131, wherein the control unit
is programmable for controlling the restriction device in
accordance with a program.
133. An apparatus according to claim 131, wherein the control unit
controls the restriction device over time in accordance with an
activity schedule program
134. An apparatus according to any one of claims 131-133, further
comprising an external wireless remote control for programming the
implantable control unit.
135. An apparatus according to claim 1, further comprising an
external data communicator and an implantable internal data
communicator communicating with the external data communicator,
wherein the internal communicator feeds data related to the
restriction device back to the external data communicator or the
external data communicator feeds data to the internal data
communicator.
136. An apparatus according to claim 135, wherein the internal data
communicator feeds data related to at least one physical signal of
the patient.
137. An apparatus according to any one of the preceding claims,
wherein the restriction device is adapted to control the
restriction of the blood flow passageway when implanted.
138. An apparatus according to any one of the preceding claims,
wherein the restriction device is non-inflatable.
139. An apparatus according to claim 2, wherein one of the energy
of the first form and the energy of the second form comprises
magnetic energy, kinetic energy, sound energy, chemical energy,
radiant energy, electromagnetic energy, photo energy, nuclear
energy or thermal energy.
140. An apparatus according to claim 2, wherein one of the energy
of the first form and the energy of the second form is
non-magnetic, non-kinetic, non-chemical, non-sonic, non-nuclear or
non-thermal.
141. An apparatus according to claim 1, wherein the energy
transmission device functions different from the energy
transforming device.
142. An apparatus according to claim 2, wherein the energy
transmission device functions similar to the energy transforming
device.
143. An apparatus according to any one of the preceding claims,
wherein the energy transforming device is designed to be implanted
subcutaneously or in the abdomen, thorax or cephalic region of the
patient.
144. An apparatus according to any one of claims 1-142, wherein the
energy transforming device is designed to be implanted in an
orifice of the patient's body and under the mucosa or intraluminar
outside the mucosa of the orifice.
145. An apparatus according to any one of claims 1-142, wherein the
energy transforming means is designed to be implanted in the
retropritoneum or in the scrotum of the patient.
146. An apparatus according to any of the preceding claims, wherein
the restriction device is embedded in a soft or gel-like
material.
147. An apparatus according to any of the preceding claims, wherein
the restriction device is embedded in a silicone material having
hardness less than 20 Shore.
148. An apparatus according to claim 102, wherein the sensor is
adapted to sense ejaculation as the physical parameter, and the
restriction device is adapted to release the penile tissue or the
prolongation thereof in response to the sensor sensing ejaculation.
Description
[0001] The present invention relates to a male sexual impotence
treatment apparatus, comprising an operable restriction device
implantable in an impotent patient for engaging a tissue portion of
the normal penile tissue or the prolongation thereof to form a
restrictable penile exit blood flow passageway.
[0002] The expression "normal penile tissue or the prolongation
thereof" should be understood to mean the penile tissue extended
inside the human body and following the pathway of the blood flow
leaving the penis i.e. one or more exit veins from the penis, the
corpus cavernosum, crura or the prolongation thereof.
[0003] Male sexual impotence is a widespread problem. Many
different solutions to this problem have been tried. A solution
currently practiced is to replace the corpus cavernosa in the penis
with a hydraulic inflatable/contractable silicon prosthesis, thus
implanted in the penis. In fluid connection with this prosthesis is
a reservoir implanted in the scrotum. By manual pumping action the
prosthesis is filled with fluid from the reservoir to effect errect
penile condition or is emptied of fluid, which returns to the
reservoir, to effect flaccid penile condition. However, there are
several more or less severe disadvantages of this solution. Above
all, the penis is more or less damaged by the operation and it is
practically impossible to reverse the operation. Another
disadvantage is that rather strong forces act against this
implanted prosthesis resulting in a significant risk of the
prosthesis being broken.
[0004] Another solution to achieve erection is to restrict the
blood flow leaving the penis. For example, U.S. Pat. Nos.
4,829,990, 4,958,630 and 5,048,511 disclose two hydraulically
operated inflatable cuffs wrapped around respective crura or veins.
A disadvantage of such a solution is that it involves complicated
surgery. Another example on this solution is U.S. Pat. No.
4,828,544, which discloses an artificial fistula system surgically
implanted and providing a primary fistula between the femoral
artery and the femoral vein and a secondary fistula for leading
blood from the the primary fistula to the penis. The inflatable
balloon engages the primary fistula between the secondary fistula
and the vein. The balloon is in fluid connection with a manually
compressible reservoir implanted in the scrotum. Again,
implantation of this artifical fistula system requires delicate
surgery. Yet another solution is to inject a substance in the
penile vein system to achieve erection. However, injections are
painful and complicated for the patient.
[0005] The object of the present invention is to provide a simple
male sexual impotence treatment apparatus, which is conveniently
controlled by the patient.
[0006] This object is obtained by an apparatus of the kind stated
initially characterised by an energy transmission device for
wireless transmission of energy from outside the patient's body to
inside the patient's body for use in connection with the operation
of the restriction device, including temporarily contracting said
tissue portion to restrict the penile exit blood flow in the blood
flow passageway to achieve erection.
[0007] As a result, the advantage is achieved that the impotence
treatment apparatus of the invention provides simple and effective
energy transmission which ensures an extended and reliable
functionality of the apparatus, possibly for the rest of the
patient's natural life, and at least many years.
[0008] The restriction device preferably controls the
cross-sectional area of the passageway through which blood flow
leaves the penis, which gives the advantage that the patient is
enabled to adjust the restriction device to acheive the desired
erection without feeling pain. This advantage should not be
underestimated, because fine adjustments to restrict the
cross-sectional area of the passageway, will allow maximal erection
with minimum of restriction.
[0009] Generally, the apparatus comprises an energy transforming
device implantable in the patient for transforming the energy
wirelessly transmitted by the energy transmission device from a
first form into a second form, preferably different than the first
form.
[0010] The energy transforming device may comprise at least one
semiconductor type of component or a circuitry of such
semiconductor components. The semiconductor component may comprise
a transistor or microchip or similar electronic components.
However, the semiconductor component may not comprise rectifying
diodes.
[0011] In accordance with a main embodiment of the invention, the
energy transforming device comprises at least one element having a
positive region and a negative region and adapted to create an
energy field between the positive and negative regions when exposed
to the energy of the first form transmitted by the energy
transmission device, so that the energy field provides the energy
of the second form. Typically, the above-mentioned semiconductor
component may include such an element.
[0012] In accordance with a preferred embodiment of the invention,
the element comprises an electrical junction element capable of
inducing an electric field between the positive and negative
regions when exposed to the energy of the first form transmitted by
the energy transmission device, whereby the energy of the second
form comprises electric energy.
[0013] Consequently, the restriction device suitably is
electrically operated, whereby the positive and negative regions of
the electrical junction element supply electric energy for the
operation of the restriction device. The apparatus suitably
comprises implantable electric conductors connected to the positive
and negative regions of the electrical junction element, whereby
the electrical junction element is capable of supplying an electric
current, such as a direct current, a pulsating direct current, a
combination of a direct and pulsating direct current, an
alternating current or a combination of a direct and alternating
current, via the conductors. Furthermore, the electrical junction
element may be capable of supplying a frequency, amplitude, or
frequency and amplitude modulated analog, digital, or a combination
of analog and digital signal, which is used in connection with
control of the restriction device.
[0014] The element, preferably in the form of an electrical
semiconductor junction element, should be designed to generate an
output current exceeding 1 .mu.A when exposed to the energy of the
first form transmitted by the energy transmission device. Suitably
the electrical junction element forms a flat and thin sheet and has
a volume of less than 2000 cm.sup.3 to be suited for subcutaneous
implantation, so that the electrical junction element can be
located just behind the skin of the patient. Alternatively, it
would be possible to implant the element in the thorax or cephalic
region of the patient, or in an orifice of the patient's body and
under the mucosa or intraluminar outside the mucosa of the orifice.
Of course, all the components of the energy transforming device
including the electrical junction element in contact with the
patient's body should be of biocompatible material.
[0015] For in vitro appliances, a particular type of an electrical
semiconductor junction element has been commonly used, namely a
so-called p-n (positive/negative) junction element, typically in
the form of solar cells. A solar cell transfers solar energy in the
form of visible light into electric energy in the form of direct
current. For example, a p-n junction element may comprise two
layers of semiconductor, one p-type (positive) and the other n-type
(negative), sandwiched together to form a "p-n junction". This p-n
junction induces an electric field across the element when
absorbing quanta of light (photons).
[0016] To be more precise, the quanta of light transfer their
energy to some of the semiconductor's electrons, which are then
able to move about through the material. For each such negatively
charged electron, a corresponding positive charge--a "hole"--is
created. In an ordinary semiconductor, these electrons and holes
recombine after a short time and their energy is wasted as heat.
However, when the electrons and holes are swept across the p-n
junction in opposite directions by the action of the electric
field, the separation of charge induces a voltage across the p-n
junction element. By connecting the p-n junction element to an
external circuit, the electrons are able to flow thereby creating a
current.
[0017] Surprisingly, it has been proved that although both the skin
and subcutis absorb energy from an external light beam directed
against the skin portion behind which a properly designed p-n
junction element is located, the light energy transmitted through
the skin can induce a current from the p-n junction element strong
enough (minimum 1 .mu.A) to enable the operation of the
electrically operated restriction device. Thus, such a p-n junction
element is now for the first time used for in vivo
applications.
[0018] The apparatus may comprise an implantable pulse generator
for generating electrical pulses from the energy of the second form
produced by the energy field.
[0019] Generally, the energy transforming device is adapted to
transform the energy of the first form directly or indirectly into
the energy of the second form.
[0020] In accordance with a preferred embodiment of the invention,
the energy of the second form comprises electric energy and the
energy transforming device comprises a capacitor, which may be
adapted to produce electric pulses from the transformed electric
energy. Preferably, the capacitor may be adapted to produce the
pulses as the energy transforming device transforms the energy of
the first form transmitted by the energy transmission device into
the electric energy of the second form. The capacitor should be
small to facilitate implantation thereof; i.e. its capacity may not
be more than 0,1 .mu.F.
[0021] The apparatus may comprise an implantable stabiliser for
stabilising the energy of the second form. Where the energy of the
second form comprises electric current the stabiliser may comprise
at least one capacitor of the type described above.
[0022] In most embodiments of the invention, the apparatus
comprises implantable electrical components. Where the electrical
components include a capacitor of the type described above or an
accumulator, at least one, preferably a single, voltage level guard
may advantageously be provided, wherein the charge and discharge of
the capacitor or accumulator is controlled by use of the voltage
level guard. As a result, there is no need for any implanted
current detector and/or charge level detector for the control of
the capacitor, which makes the apparatus simple and reliable.
[0023] In a particular embodiment of the invention, the wireless
energy of the first form comprises sound waves and the energy of
the second form comprises electric energy, wherein the energy
transforming device is adapted to directly transform the sound
waves into electric energy.
[0024] The apparatus may comprise an implantable motor or pump for
operating the restriction device, wherein the motor or pump is
powered by the transformed energy.
[0025] In accordance with a main aspect of the invention, the
energy transmission device may be adapted to transmit wireless
energy for direct use in connection with the operation of the
restriction device, as the wireless energy is being transmitted.
The advantage of directly using energy as it is transmitted is that
the apparatus can be of a very simple design and the few components
involved makes the apparatus extremely reliable. For example, the
energy transmission device may be adapted to directly power the
motor or pump with wireless energy. The wireless energy may
comprise a magnetic field or electromagnetic waves, suitably in the
form of a signal, for direct power of the motor or pump. All the
various functions of the motor and associated components described
in the present specification may be used where applicable.
[0026] As an alternative to the above-noted main aspect of the
invention, the energy transforming device may be adapted to supply
the energy of the second form for direct use in connection with the
operation of the restriction device, as the energy of the first
form is being transformed into the energy of the second form.
Consequently, the energy transforming device may be adapted to
directly power the motor or pump with the energy of the second
form.
[0027] Generally, the energy transforming device directly operates
the restriction device with the energy of the second form in a
non-magnetic, non-thermal or non-mechanical manner.
[0028] Where the apparatus comprises a motor, which may be adapted
to directly or intermittently operate the restriction device, the
energy transforming device may power the motor with the energy of
the second form. Suitably, the restriction device is operable to
perform a reversible function and the motor is capable of reversing
said function.
[0029] In accordance with another embodiment of the invention, the
restriction device comprises a hydraulic restriction device, and
the apparatus comprises an implantable pump for operating the
hydraulic restriction device, wherein the energy transforming
device supplies the energy of the second form for driving the pump.
Preferably, the pump is not a plunger type of pump, but may
comprise a peristaltic or membrane pump.
[0030] The energy transforming device preferably is capable of
generating as the energy of the second form a current exceeding 1
.mu.A, when transferring the energy of the first form transmitted
by the energy transmission device.
[0031] The apparatus may comprise an implantable adjustment device
for adjusting the restriction device to change the restriction of
the faecal passageway. In accordance with a first alternative the
adjustment device is adapted to mechanically adjust the restriction
device. In accordance with a second alternative the adjustment
device is adapted to hydraulically adjust the restriction device by
using implanted hydraulic means. Such hydraulic means may not use
hydraulic fluid of the kind having a viscosity that substantially
increases when exposed to heat or a magnetic field.
[0032] The apparatus of the present invention is not limited to the
use of visible light for the wireless transmission of energy. Thus,
in accordance with a broad aspect of the invention, the energy
transmission device transmits energy by at least one wireless
signal, preferably containing radiant energy.
[0033] The wireless signal may comprises a wave signal, for example
an electromagnetic wave signal, such as an infrared light signal, a
visible light signal, an ultra violet light signal, a laser signal,
a micro wave signal, a radio wave signal, an x-ray radiation
signal, and a gamma radiation signal. Where applicable, one or more
of the above signals may be combined. Alternatively, the wave
signal may comprise a sound wave signal, such as an ultrasonic
signal. Generally, the wireless signal may comprise a digital,
analog or a digital and analog signal.
[0034] The energy of the first form transmitted by the energy
transmission device may comprise an electric or magnetic field
transmitted in pulses, for example digital pulses. Furthermore, the
energy transforming device may transform the energy of the first
form, which may comprise polarised energy, into a direct current,
pulsating direct current, a combination of a direct and pulsating
direct current, an alternating current or a combination of a direct
and alternating current. Alternatively, the energy of the first
form may comprise kinetic energy.
[0035] The energy of the second form may comprise a frequency,
amplitude or frequency and amplitude modulated analog, digital or
combined analog and digital signal.
[0036] The restriction device may be non-inflatable, i.e. with no
hydraulic fluid involved for the adjustments of the restriction
device. This eliminates problems with fluid leaking from the
restriction device.
[0037] The apparatus suitably comprises implantable electric
conductors connected to the energy transforming device, whereby the
energy transforming device is capable of supplying an electric
current, such as direct current, a pulsating direct current, a
combination of a direct and pulsating direct current, an
alternating current or a combination of a direct and alternating
current, via the conductors. Furthermore, the energy transforming
device may be capable of supplying a frequency, amplitude, or
frequency and amplitude modulated analog, digital, or a combination
of analog and digital signal, which is used in connection with
control of the restriction device.
[0038] In accordance with a main embodiment of the invention, the
apparatus comprises an implantable operation device for operating
the restriction device and a control device for controlling the
operation device, wherein the energy transforming device powers the
operation device with the energy of the second form. The operation
device preferably comprises a motor, for example an electric linear
motor or an electric rotary motor that is controlled by the control
device to rotate a desired number of revolutions. Optionally, an
implantable gearing may be connected to the motor. The electric
motor may have electrically conductive parts made of plastics.
Alternatively, the motor may comprise a hydraulic or pneumatic
fluid motor, wherein the control device controls the fluid flow
through the fluid motor. Motors currently available on the market
are getting smaller and smaller. Furthermore, there is a great
variety of control methods and miniaturised control equipment
available. For example, the number of revolutions of a rotary motor
may be analysed by a Hall-element just a few mm in size.
[0039] In accordance with another embodiment of the invention, the
restriction device comprises hydraulic means and the operation
device is adapted to conduct a hydraulic fluid in the hydraulic
means. The operation device comprises a fluid conduit connected to
the hydraulic means of the restriction device, and a reservoir for
fluid, wherein the reservoir forms part of the conduit. The
reservoir may form a fluid chamber with a variable volume, and the
operation device may be adapted to distribute fluid from the
chamber to the hydraulic means of the restriction device by
reduction of the volume of the chamber and to withdraw fluid from
the hydraulic means to the chamber by expansion of the volume of
the chamber. The operation device suitably comprises an implantable
motor used for reducing and expanding the volume of the chamber.
Also, the operation device may comprise a pump for pumping the
hydraulic fluid in the hydraulic means of the restriction device.
All of the hydraulic components involved are preferably devoid of
any non-return valve. This is of great advantage, because with
valves involved there is always a risk of malfunction due to
improperly working valves, especially when long time periods passes
between valve operations.
[0040] The control device may be adapted to reverse the operation
device by shifting polarity of the energy of the second form. Where
the operation device comprises an electric motor the energy of the
second form suitably comprises electric energy.
[0041] In accordance with yet another embodiment of the invention,
the restriction device is operable to perform a reversible
function, such as enlarging and restricting the blood flow
passageway, and there is a reversing device implanted in the
patient for reversing the function performed by the restriction
device. Such a reversing function preferably involves enlarging and
restricting the blood flow passageway by the restriction device,
suitably in a stepless manner. In this connection, the control
device suitably controls the reversing device, which may include a
switch, to reverse the function performed by the restriction
device. The reversing device may comprise hydraulic means including
a valve for shifting the flow direction of a fluid in the hydraulic
means. Alternatively, the reversing device may comprise a
mechanical reversing device, such as a switch or a gearbox.
[0042] Where the reversing device comprises a switch it may be
operable by the energy of the second form. In this case, the
control device suitably controls the operation of the switch by
shifting polarity of the energy of the second form supplied to the
switch. The switch may comprise an electric switch and the source
of energy may supply electric energy for the operation of the
switch.
[0043] In accordance with an advantageous embodiment of the
invention, the apparatus further comprises an energy storage device
implanted in the patient for storing the energy of the second form
and for supplying energy in connection with the operation of the
restriction device. The implanted energy storage device preferably
comprises an electric source of energy, such as an accumulator, a
rechargeable battery or a combination of an accumulator and
rechargeable battery.
[0044] The apparatus may further comprise a switch implantable in
the patient for switching the operation of the restriction device
and a source of energy implantable in the patient. This embodiment
is particularly suited for applications where the energy
transmission efficiency of the apparatus is insufficient, i.e.
where the implanted restriction device is to perform more advanced
operations. Such a source of energy preferably is a battery.
Alternatively, the source of energy is an accumulator that also may
store the energy of the second form.
[0045] In accordance with a first alternative, the switch is
operated by the energy of the second form supplied by the energy
storage device to switch from an off mode, in which the source of
energy is not in use, to an on mode, in which the source of energy
supplies energy for the operation of the restriction device. In
this case, the implanted source of energy may comprise a battery,
preferably having a lifetime of at least 10 years, or an
accumulator. However, other kinds of sources are also conceivable,
such as a nuclear source of energy or a chemical source of energy
(fuel cells).
[0046] In accordance with a second alternative, the apparatus
further comprises a remote control for controlling the supply of
energy of the implanted source of energy, wherein the switch is
operated by the energy of the second form supplied by the energy
storage device to switch from an off mode, in which the remote
control is prevented from controlling the source of energy and the
source of energy is not in use, to a standby mode, in which the
remote control is permitted to control the source of energy to
supply energy for the operation of the restriction device.
[0047] In accordance with a third alternative, the energy storage
device is omitted, wherein the switch is operated by the energy of
the second form supplied by the energy transforming device to
switch from an off mode, in which the remote control is prevented
from controlling the source of energy and the source of energy is
not in use, to a standby mode, in which the remote control is
permitted to control the source of energy to supply energy for the
operation of the restriction device.
[0048] In accordance with a fourth alternative, also the remote
control is omitted, wherein the switch is operated by the energy of
the second form supplied by the energy transforming device to
switch from an off mode, in which the source of energy is not in
use, to an on mode, in which the source of energy supplies energy
for the operation of the restriction device. Where applicable, in
the described embodiments the switch may switch when the energy
transmission device is transmitting wireless energy, preferably
while the transferred energy of the second form is stabilised by an
implanted capacitor, which may temporarily (for a few seconds)
store the energy of the second form.
[0049] In the above noted third and fourth alternatives, the energy
transmission device may be substituted for the energy transforming
device, whereby the switch is operated by the energy of the first
form.
[0050] The switch mentioned above may comprise an electronic switch
or, where applicable, a mechanical switch.
[0051] The advantage of using a switch above all is increased
control safety; i.e. interfering signals in the patient's
surroundings cannot affect the implanted restriction device.
Furthermore, the lifetime of the implanted source of energy will be
significantly prolonged, since the energy consumption of the
apparatus will be reduced to a minimum. During the above-mentioned
standby mode, the remote control uses energy from the implanted
source of energy. By means of the energy transmission device energy
may be transmitted to activate the switch to connect the implanted
source of energy only when energy is required in connection with
the operation of the restriction device.
[0052] All of the above embodiments may be combined with at least
one implantable sensor for sensing at least one physical parameter
of the patient, wherein the control device may control the
restriction device in response to signals from the sensor.
Advantageously, the sensor may sense ejaculation, and the
restriction device may release said tissue portion in response to
the sensor sensing ejaculation.
[0053] The control device may comprise an internal control unit
implantable in the patient for, preferably directly, controlling
the restriction device in response to signals from the sensor. In
response to signals from the sensor, for example signals related to
pressure, the patient's position or any other important physical
parameter, the internal control unit may send information thereon
to outside the patient's body. The control device may also
automatically control the restriction device in response to signals
from the sensor. For example, the control device may control the
restriction device to further restrict the blood flow passageway in
response to the sensor sensing that the patients blood flow and
blood pressure are increasing, or enlarge the blood flow passageway
in response to the sensor sensing an abnormally high pressure
against the restriction device or sensing ejaculation.
[0054] Alternatively, the control device may comprise an external
control unit outside the patient's body for, suitably directly,
controlling the restriction device in response to signals from the
sensor. The external control unit may store information on the
physical parameter sensed by the sensor and may be manually
operated to control the restriction device based on the stored
information. In addition, there may be at least one implantable
sender for sending information on the physical parameter sensed by
the sensor.
[0055] An external data communicator may be provided outside the
patient's body and an internal data communicator may be implanted
in the patient for communicating with the external communicator.
The internal communicator may feed data related to the patient, or
related to the restriction device, back to the external
communicator. Alternatively or in combination, the external
communicator may feed data to the internal communicator. The
internal communicator may suitably feed data related to at least
one physical signal of the patient.
[0056] The apparatus may further comprise an implantable
programmable control unit for controlling the restriction device,
preferably over time in accordance with an activity schedule
program. This will advance the apparatus and make possible an
adaptation of the apparatus to the individual patients.
[0057] Many of the above embodiments are suitably remote
controlled. Thus, the apparatus advantageously comprises a wireless
remote control transmitting at least one wireless control signal
for controlling the restriction device. With such a remote control
it will be possible to adapt the function of the apparatus to the
patient's need. The control signal may comprise a frequency,
amplitude or frequency or amplitude modulated signal. Furthermore,
the control signal may comprise an analog or a digital signal, or a
combination of an analog and digital signal.
[0058] The wireless remote control may be capable of obtaining
information on the condition of the implanted restriction device
and of controlling the restriction device in response to the
information. Also, The remote control may be capable of sending
information related to the restriction device from inside the
patient's body to the outside thereof.
[0059] In a particular embodiment of the invention, the wireless
remote control comprises at least one external signal transmitter
or transceiver and at least one internal signal receiver or
transceiver implantable in the patient. In another particular
embodiment of the invention, the wireless remote control comprises
at least one external signal receiver or transceiver and at least
one internal signal transmitter or transceiver implantable in the
patient.
[0060] The wireless remote control may transmit a carrier signal
for carrying the control signal, wherein the carrier signal is
frequency, amplitude or frequency and amplitude modulated. The
carrier signal may also comprise digital, analog or a combination
of digital and analog signals. Such signals may comprise wave
signals. Also the control signal used with the carrier signal may
be frequency, amplitude or frequency and amplitude modulated, and
be digital, analog or combined digital and analog.
[0061] The control signal may comprise a wave signal, for example,
a sound wave signal, such as an ultrasound wave signal, an
electromagnetic wave signal, such as an infrared light signal, a
visible light signal, an ultra violet light signal, a laser signal,
a micro wave signal, a radio wave signal, an x-ray radiation
signal, or a gamma radiation signal. Where applicable, two or more
of the above signals may be combined.
[0062] The control signal may be digital or analog, and may
comprise an electric or magnetic field. Suitably, the wireless
remote control may transmit an electromagnetic carrier wave signal
for carrying the digital or analog control signal. For example, use
of an analog carrier wave signal carrying a digital control signal
would give safe communication. The control signal may be
transmitted in pulses by the wireless remote control.
[0063] The energy transmission device may function different from
or similar to the energy transforming device. For example, the
energy transmission and transforming devices function differently
when the energy transmission device comprises a coil used for
transmitting the energy of the first form and the energy
transforming device comprises an electrical junction element for
transforming the transmitted energy into the energy of the second
form. The energy transmission and transforming devices function
similar to each other when the energy transmission device comprises
a coil used for transmitting the energy of the first form and the
energy transforming device also comprises a coil for transforming
the transmitted energy into the energy of the second form.
[0064] In accordance with an alternative embodiment of the
invention, the apparatus comprises an activatable source of energy
implantable in the patient, wherein the source of energy is
activated by wireless energy transmitted by the energy transmission
device, to supply energy which is used in connection with the
operation of the restriction device.
[0065] The implantable restriction device suitably is embedded in a
soft or gel-like material. For example, a silicone material having
hardness less than 20 Shore.
[0066] All the above described various components, such as the
motor, pump and capacitor, may be combined in the different
embodiments where applicable. Also the various functions described
in connection with the above embodiments of the invention may be
used in different applications, where applicable.
[0067] All the various ways of transferring, transforming and
controlling energy presented in the present specification may be
practised by using all of the various components and solutions
described.
[0068] The present invention also provides methods for implanting
the apparatus of the invention, and for treating impotence.
[0069] Accordingly, there is provided an implanting method,
comprising the steps of: providing an impotence treatment apparatus
as described above, cutting an opening in a patient's mucosa in the
orifice of the patient's body, and implanting the energy
transforming means in the patient's body through the opening.
Alternatively, the cutting step may comprise cutting the opening in
the patient's skin and the implanting step may comprise implanting
the energy transforming means in the patient's body through the
opening.
[0070] There is also provided a laparascopical implanting method,
comprising the steps of: providing the impotence treatment
apparatus as desribed above, placing at least two laparascopic
cannula within a patient's body, and implanting the energy
transforming means in the patient's body by using the at least two
laparascopic cannula.
[0071] In accordance with another alternative there is provided a
laparascopical surgical method of implanting the impotence
treatment apparatus, comprising the steps of: a) Providing the
impotence treatment apparatus as desribed above. b) Placing at
least two laparoscopic trocars within the patient's body. c) Using
a dissecting tool inserted through the laparoscopic trocars,
dissecting the region of the penile tissue or the prolongation
thereof. d) Introducing the operable restriction device of the
apparatus through the trocars. e) Placing the restriction device in
engagement with the penile tissue or the prolongation thereof to
create a stoma through which blood flow leaves the penis. And f)
implanting the energy transforming means of the apparatus in the
patient for transforming wireless energy into energy of a form
suited for operating the restriction device to reduce the stoma to
restrict the blood flow therethrough. The method as recited in
(a)-(f) may further comprise adjusting the reduced stoma in a
non-invasive procedure.
[0072] There is also provided a method of treating an impotent male
comprising: (a) Surgically implanting in a male patient a
restriction device engaging the male's penile tissue or the
prolongation thereof to form a restrictable passageway in which
blood flow leaves the penis. (b) Surgically implanting in the male
the operation device which can adjust the restricted passageway in
response to supplied energy. And (c) in a non-invasive
post-operative procedure, from time to time, supplying energy to
the operation device so as to restrict the passageway to reduce the
blood flow leaving the male's penis to achieve erection. In the
method (c) may be practised by the patient whenever he desires.
[0073] The invention is described in more detail in the following
with reference to the accompanying drawings, in which
[0074] FIGS. 1 to 12 are schematic block diagrams illustrating
twelve embodiments, respectively, of the male sexual impotence
treatment apparatus of the invention, in which wireless energy is
transmitted from outside a patient's body to energy consuming
components of the apparatus implanted in the patient;
[0075] FIG. 13 is a schematic block diagram illustrating
conceivable combinations of implanted components for achieving
various communication options;
[0076] FIG. 14 illustrates an electrical junction element for use
in the apparatus of the present invention; and
[0077] FIG. 15 illustrates the apparatus in accordance with the
invention implanted in a patient.
[0078] FIG. 16 is a block diagram illustrating remote control
components of an embodiment of the invention, in which wireless
energy is transmitted by the use of electromagnetic signals;
and
[0079] FIG. 17 is a schematic view of exemplary circuitry used for
the components of the block diagram of FIG. 16.
[0080] Referring to the drawing figures, like reference numerals
designate identical or corresponding elements throughout the
several figures.
[0081] FIG. 1 schematically shows a very simple embodiment of the
impotence apparatus of the invention having some parts implanted in
a patient and other parts located outside the patient's body. Thus,
in FIG. 1 all parts placed to the right of the patient's skin 2 are
implanted and all parts placed to the left of the skin 2 are
located outside the patient's body.
[0082] The apparatus of FIG. 1 comprises an implanted operable
restriction device 4, which engages penile tissue or the
prolongation thereof to form a restrictable passageway for blood
flow leaving the penis. The restriction device 4 is capable of
performing a reversible function, i.e. to enlarge and restrict the
passageway, so that the restriction device 4 works as an artificial
sphincter. The implanted energy transforming means 6 is adapted to
supply energy consuming components of the restriction device 4 with
energy via a power supply line 12. The external energy transmission
means 10 includes a wireless remote control transmitting a wireless
signal which is received by a signal receiver incorporated in the
implanted energy transforming means 6. The implanted energy
transforming means 6 transforms energy from the signal into
electric energy which is supplied via the power supply line 12 to
the restriction device 4, which energy causes portions of the
device 4 to move and thus adjust the opening.
[0083] FIG. 2 shows an embodiment of the invention identical to
that of FIG. 1, except that a reversing device in the form of an
electric switch 14 also is implanted in the patient for reversing
the restriction device 4. The wireless remote control of the
external energy transmission means 10 transmits a wireless signal
that carries energy and the implanted energy transforming means 6
transforms the wireless energy into a current for operating the
switch 14. When the polarity of the current is shifted by the
energy transforming means 6 the switch 14 reverses the function
performed by the restriction device 4.
[0084] FIG. 3 shows an embodiment of the invention identical to
that of FIG. 1, except that the operation device in the form of a
motor 15 for operating the restriction device 4 also is implanted
in the patient. The motor 15 is powered with energy from the energy
transforming means 6, as the remote control of the external energy
transmission means 10 transmits a wireless signal to the receiver
of the energy transforming means 6.
[0085] FIG. 4 shows an embodiment of the invention identical to
that of FIG. 1, except that an assembly 16 including a motor/pump
unit 18 and a fluid reservoir 20 also is implanted in the patient.
In this case the restriction device 4 is hydraulically operated,
i.e. hydraulic fluid is pumped by the motor/pump unit 18 from the
reservoir 20 through a conduit 22 to the restriction device 4 to
restrict the passageway, and hydraulic fluid is pumped by the
motor/pump unit 18 back from the restriction device 4 to the
reservoir 20 to enlarge the cross-sectional area. The implanted
energy transforming means 6 transforms wireless energy into a
current, for powering the motor/pump unit 18 via the electric power
supply line 24.
[0086] FIG. 5 shows an embodiment of the invention comprising the
external energy transmission means 10 with its wireless remote
control, the restriction device 4, in this case hydraulically
operated, and the implanted energy transforming means 6, and
further comprising an implanted hydraulic fluid reservoir 30, an
implanted motor/pump unit 32 and an implanted reversing device in
the form of a hydraulic valve shifting device 34. The motor of the
motor/pump unit 32 is the electric motor. In response to a control
signal from the wireless remote control of the external energy
transmission means 10, the implanted energy transforming means 6
powers the motor/pump unit 32 with energy from the energy carried
by the control signal, whereby the motor/pump unit 32 distributes
hydraulic fluid between the reservoir 30 and the restriction device
4. The remote control of the energy transmission means 10 controls
the shifting device 34 to shift the hydraulic fluid flow direction
between one direction in which the fluid is pumped by the
motor/pump unit 32 from the reservoir 30 to the restriction device
4 to reduce the passageway, and another opposite direction in which
the fluid is pumped by the motor/pump unit 32 back from the
restriction device 4 to the reservoir 30 to enlarge the
cross-sectional area.
[0087] FIG. 6 shows an embodiment of the invention identical to
that of FIG. 1, except that a control unit 36 controlled by the
wireless remote control of the external energy transmission means
10, an accumulator 38 and a capacitor 40 also are implanted in the
patient. The control unit 36 stores electric energy received from
the energy transforming means 6 in the accumulator 38, which
supplies energy to the restriction device 4. In response to a
control signal from the wireless remote control of the energy
transmission means 10, the control unit 6 either releases electric
energy from the accumulator 38 and transfers the released energy
via power lines 42 and 44, or directly transfers electric energy
from the energy transforming means 6 via a power line 46, the
capacitor 40, which stabilises the electric current, a power line
48 and the power line 44, for the operation of the restriction
device 4.
[0088] In accordance with one alternative, the capacitor 40 in the
embodiment of FIG. 6 may be omitted. In accordance with another
alternative, the accumulator 38 in this embodiment may be
omitted.
[0089] FIG. 7 shows an embodiment of the invention identical to
that of FIG. 1, except that a battery 50 for supplying energy for
the operation of the restriction device 4 and an electric switch 52
for switching the operation of the restriction device 4 also are
implanted in the patient. The switch 52 is operated by the energy
supplied by the energy transforming means 6 to switch from an off
mode, in which the battery 50 is not in use, to an on mode, in
which the battery 50 supplies energy for the operation of the
restriction device 4.
[0090] FIG. 8 shows an embodiment of the invention identical to
that of FIG. 7, except that a control unit 36 controllable by the
wireless remote control of the external energy transmission means
10 also is implanted in the patient. In this case, the switch 52 is
operated by the energy supplied by the energy transforming means 6
to switch from an off mode, in which the wireless remote control is
prevented from controlling the control unit 36 and the battery 50
is not in use, to a standby mode, in which the remote control is
permitted to control the control unit 36 to release electric energy
from the battery 50 for the operation of the restriction device
4.
[0091] FIG. 9 shows an embodiment of the invention identical to
that of FIG. 8, except that the accumulator 38 is substituted for
the battery 50 and the implanted components are interconnected
differently. In this case, the accumulator 38 stores energy from
the energy transforming means 6. In response to a control signal
from the wireless remote control of the external energy
transmission means 10, the implanted control unit 36 controls the
switch 52 to switch from an off mode, in which the accumulator 38
is not in use, to an on mode, in which the accumulator 38 supplies
energy for the operation of the restriction device 4.
[0092] FIG. 10 shows an embodiment of the invention identical to
that of FIG. 9, except that the battery 50 also is implanted in the
patient and the implanted components are interconnected
differently. In response to a control signal from the wireless
remote control of the external energy transmission means 10, the
implanted control unit 36 controls the accumulator 38 to deliver
energy for operating the switch 52 to switch from an off mode, in
which the battery 50 is not in use, to an on mode, in which the
battery 50 supplies electric energy for the operation of the
restriction device 4.
[0093] Alternatively, the switch 52 may be operated by energy
supplied by the accumulator 38 to switch from an off mode, in which
the wireless remote control is prevented from controlling the
battery 50 to supply electric energy and the battery 50 is not in
use, to a standby mode, in which the wireless remote control is
permitted to control the battery 50 to supply electric energy for
the operation of the restriction device 4.
[0094] FIG. 11 shows an embodiment of the invention identical to
that of FIG. 7, except that a motor 15, a mechanical reversing
device in the form of a gearbox 54 and a control unit 36 for
controlling the gearbox 54 also are implanted in the patient. The
implanted control unit 36 controls the gearbox 54 to reverse the
function performed by the restriction device 4 (mechanically
operated).
[0095] FIG. 12 shows an embodiment of the invention identical to
that of FIG. 10 except that the implanted components are
interconnected differently. Thus, in this case the battery 50
powers the control unit 36 when the accumulator 38, suitably a
capacitor, activates the switch 52 to switch to an on mode. When
the switch 52 is in its on mode the control unit 36 is permitted to
control the battery 50 to supply, or not supply, energy for the
operation of the restriction device 4.
[0096] FIG. 13 schematically shows conceivable combinations of
implanted components of the apparatus for achieving various
communication options. Basically, there are the implanted
restriction device 4, control unit 36 and motor/pump unit 18, and
the external energy transmission means 10 including the external
wireless remote control. As already described above the wireless
remote control transmits a control signal which is received by the
implanted control unit 36, which in turn controls the various
implanted components of the apparatus.
[0097] A sensor 56 may be implanted in the patient for sensing a
physical parameter of the patient, such as the pressure in the
passageway. The implanted control unit 36, or alternatively the
external wireless remote control of the energy transmission means
10, may control the restriction device 4 in response to signals
from the sensor 56. A transceiver may be combined with the sensor
56 for sending information on the sensed physical parameter to the
external wireless remote control. The wireless remote control may
comprise a signal transmitter or transceiver and the implanted
control unit 36 may comprise a signal receiver or transceiver.
Alternatively, the wireless remote control may comprise a signal
receiver or transceiver and the implanted control unit 36 may
comprise a signal transmitter or transceiver. The above
transceivers, transmitters and receivers may be used for sending
information or data related to the restriction device 4 from inside
the patient's body to the outside thereof.
[0098] Where the motor/pump unit 18 and battery 50 for powering the
motor/pump unit 18 are implanted, the battery 50 may be equipped
with a transceiver for sending information on the condition of the
battery 50.
[0099] Those skilled in the art will realise that the above various
embodiments according to FIGS. 1-13 could be combined in many
different ways. For example, the energy operated switch 14 could be
incorporated in any of the embodiments of FIGS. 3,6-12, the
hydraulic shifting device 34 could be incorporated in the
embodiment of FIG. 4, and the gearbox 54 could be incorporated in
the embodiment of FIG. 3.
[0100] FIG. 14 shows the energy transforming means in the form of
an electrical junction element 58 for use in any of the above
embodiments according to FIGS. 1-13. The element 58 is a flat p-n
junction element comprising a p-type semiconductor layer 60 and an
n-type semiconductor layer 62 sandwiched together. A light bulb 64
is electrically connected to opposite sides of the element 58 to
illustrate how the generated current is obtained. The output of
current from such a p-n junction element 58 is correlated to the
temperature. See the formula below.
I=I0(exp(qV/kT)-1)
[0101] where
[0102] I is the external current flow,
[0103] I0 is the reverse saturation current,
[0104] q is the fundamental electronic charge of 1.602.times.10-19
coulombs,
[0105] V is the applied voltage,
[0106] k is the Boltzmann constant, and
[0107] T is the absolute temperature.
[0108] Under large negative applied voltage (reverse bias), the
exponential term becomes negligible compared to 1.0, and I is
approximately -I0. I0 is strongly dependent on the temperature of
the junction and hence on the intrinsic-carrier concentration. I0
is larger for materials with smaller bandgaps than for those with
larger bandgaps. The rectifier action of the diode, that is, its
restriction of current flow to only one direction, is in this
particular embodiment the key to the operation of the p-n junction
element 58.
[0109] The alternative way to design a p-n junction element is to
deposit a thin layer of semiconductor onto a supporting material
which does not absorb the kind of energy utilised in the respective
embodiments. For use with wirelessly transmitted energy in terms of
light waves, glass could be a suitable material. Various materials
may be used in the semiconductor layers such as but not limited to
cadmium telluride, copper-indium-diselenide and silicon. It is also
possible to use a multilayer structure with several layers of p and
n-type materials to improve efficiency.
[0110] The electric energy generated by the p-n junction element 58
could be of the same type as generated by solar cells, in which the
negative and positive fields create a direct current.
Alternatively, the negative and positive semiconductor layers may
change polarity following the transmitted waves, thereby generating
the alternating current.
[0111] The p-n junction element 58 is designed to make it suited
for implantation. Thus, all the external surfaces of the element 58
in contact with the human body are made of a biocompatible
material. The p-n junction semiconductors are designed to operate
optimally at a body temperature of 37.degree. C. because the
current output, which should be more than 1 .mu.A, is significantly
depending on temperature as shown above. Since both the skin and
subcutis absorb energy, the relation between the sensitivity or
working area of the element 58 and the intensity or strength of the
wireless energy transmission is considered. The p-n junction
element 58 preferably is designed flat and small. Alternatively, if
the element 58 is made in larger sizes it should be flexible, in
order to adapt to the patient's body movements. The volume of the
element 58 should be kept less than 2000 cm.sup.3.
[0112] FIG. 15 generally illustrates how any of the above-described
embodiments of the impotence treatment apparatus of the invention
may be implanted in a male patient. Thus, a restriction device 4
implanted in a patient engages penile tissue or the prolongation
thereof to form an artificial sphincter around the passageway
through which the blood flow leaves the penis. An implanted
operation device 68, which may also be referred to as an adjustment
device, such as an electric motor or a motor/pump assembly,
operates the restriction device 4 through a transmission member 70,
such as a mechanical transmission cord or a fluid tube. The energy
transforming means in the form of the element 6 having a positive
region and a negative region, as described above in more detail, is
placed underneath the skin of the patient. The external energy
transmission means 10 is adapted to transmit wireless energy to the
implanted element 6. A wireless remote control includes an external
control unit incorporated in the energy transmission means 10, and
an implanted control unit 71 connected to the element 6 and the
operation device 68.
[0113] Wireless energy carried by a signal transmitted by the
wireless remote control of the external energy transmission means
10 at least partly penetrates the patient's skin and hits the
element 6. The energy thus hitting the element 6 is transformed
into energy of a different form that is suited for powering the
operation device 68. For example, where the operation device 68 is
an electric motor the element 6 comprises an electric p-n junction
element that transforms the wireless energy into an electric
current for powering the electric motor. Where the operation device
68 comprises a pump, the element 6 may transform the wireless
energy into kinetic energy for powering the pump.
[0114] The transformed energy may be utilised for directly
operating the restriction device 4 or, where the restriction device
4 is electrically operated, for storage in a capacitor and/or an
accumulator for later or parallel use. Preferably (but not
necessarily) the element 6 is controlled by a microprocessor. The
wireless remote control of the external energy transmission means
10 is used to control the utilisation of the transmitted energy and
any function or command to/from the implanted restriction device
4.
[0115] FIG. 16 shows the basic parts of a wireless remote control
of the apparatus of the invention including an electric motor 128
for operating a restriction member, for example of the type
illustrated in FIG. 15. In this case, the remote control is based
on the transmission of electromagnetic wave signals, often of high
frequencies in the order of 100 kHz-1 gHz, through the skin 130 of
the patient. In FIG. 15, all parts placed to the left of the skin
130 are located outside the patient's body and all parts placed to
the right of the skin 130 are implanted. Any suitable remote
control system may be used.
[0116] An external signal transmitting antenna 132 is to be
positioned close to a signal receiving antenna 134 implanted close
to the skin 130. As an alternative, the receiving antenna 134 may
be placed for example inside the abdomen of the patient. The
receiving antenna 134 comprises a coil, approximately 1-100 mm,
preferably 25 mm in diameter, wound with a very thin wire and tuned
with a capacitor to a specific high frequency. A small coil is
chosen if it is to be implanted under the skin of the patient and a
large coil is chosen if it is to be implanted in the abdomen of the
patient. The transmitting antenna 132 comprises a coil having about
the same size as the coil of the receiving antenna 134 but wound
with a thick wire that can handle the larger currents that is
necessary. The coil of the transmitting antenna 132 is tuned to the
same specific high frequency as the coil of the receiving antenna
134.
[0117] An external control unit 136 comprises a microprocessor, a
high frequency electromagnetic wave signal generator and a power
amplifier. The microprocessor of the control unit 136 is adapted to
switch the generator on/off and to modulate signals generated by
the generator to send digital information via the power amplifier
and the antennas 132,134 to an implanted control unit 138. To avoid
that accidental random high frequency fields trigger control
commands, digital signal codes are used. A conventional keypad
placed on the external control unit 136 is connected to the
microprocessor thereof. The keypad is used to order the
microprocessor to send digital signals to either contract or
enlarge the restriction device. The microprocessor starts a command
by applying a high frequency signal on the antenna 132. After a
short time, when the signal has energised the implanted parts of
the control system, commands are sent to contract or enlarge the
restriction device in predefined steps. The commands are sent as
digital packets in the form illustrated below.
1 Start pattern, Command, Count, Checksum, 8 bits 8 bits 8 bits 8
bits
[0118] The commands are sent continuously during a rather long time
period (e.g. about 30 seconds or more). When a new contract or
enlarge step is desired the Count byte is increased by one to allow
the implanted control unit 138 to decode and understand that
another step is demanded by the external control unit 136. If any
part of the digital packet is erroneous, its content is simply
ignored.
[0119] Through a line 140, an implanted energiser unit 126 draws
energy from the high frequency electromagnetic wave signals
received by the receiving antenna 134. The energiser unit 126
stores the energy in an energy storage device, such as a large
capacitor, powers the control unit 138 and powers the electric
motor 128 via a line 142.
[0120] The control unit 138 comprises a demodulator and a
microprocessor. The demodulator demodulates digital signals sent
from the external control unit 136. The microprocessor of the
control unit 138 receives the digital packet, decodes it and,
provided that the power supply of the energiser unit 126 has
sufficient energy stored, sends a signal via a signal line 144 to
the motor 128 to either contract or enlarge the restriction device
depending on the received command code.
[0121] Alternatively, the energy stored in the energy storage
device of the energiser unit may only be used for powering a
switch, and the energy for powering the motor 128 may be obtained
from another implanted energy source of relatively high capacity,
for example a battery. In this case the switch is adapted to
connect said battery to the control unit 138 in an on mode when
said switch is powered by the energy storage device and to keep the
battery disconnected from the control unit in a standby mode when
the switch is not powered.
[0122] With reference to FIG. 17, the remote control schematically
described above will now be described in accordance with a more
detailed embodiment. The external control unit 136 comprises a
microprocessor 146, a signal generator 148 and a power amplifier
150 connected thereto. The microprocessor 146 is adapted to switch
the signal generator 148 on/off and to modulate signals generated
by the signal generator 148 with digital commands that are sent to
implanted components of the apparatus. The power amplifier 150
amplifies the signals and sends them to the external signal
transmitting antenna 132. The antenna 132 is connected in parallel
with a capacitor 152 to form a resonant circuit tuned to the
frequency generated by the signal generator 148.
[0123] The implanted signal receiving antenna coil 134 forms
together with a capacitor 154 a resonant circuit that is tuned to
the same frequency as the transmitting antenna 132. The signal
receiving antenna coil 134 induces a current from the received high
frequency electromagnetic waves and a rectifying diode 160
rectifies the induced current, which charges a storage capacitor
158. A coil 156 connected between the antenna coil 134 and the
diode 160 prevents the capacitor 158 and the diode 160 from loading
the circuit of the signal receiving antenna 134 at higher
frequencies. Thus, the coil 156 makes it possible to charge the
capacitor 158 and to transmit digital information using amplitude
modulation.
[0124] A capacitor 162 and a resistor 164 connected in parallel and
a diode 166 forms a detector used to detect amplitude modulated
digital information. A filter circuit is formed by a resistor 168
connected in series with a resistor 170 connected in series with a
capacitor 172 connected in series with the resistor 168 via ground,
and a capacitor 174, one terminal of which is connected between the
resistors 168,170 and the other terminal of which is connected
between the diode 166 and the circuit formed by the capacitor 162
and resistor 164. The filter circuit is used to filter out
undesired low and high frequencies. The detected and filtered
signals are fed to an implanted microprocessor 176 that decodes the
digital information and controls the motor 128 via an H-bridge 178
comprising transistors 180,182,184 and 186. The motor 128 can be
driven in two opposite directions by the H-bridge 178.
[0125] The microprocessor 176 also monitors the amount of stored
energy in the storage capacitor 158. Before sending signals to
activate the motor 128, the microprocessor 176 checks whether the
energy stored in the storage capacitor 158 is enough. If the stored
energy is not enough to perform the requested operation, the
microprocessor 176 waits for the received signals to charge the
storage capacitor 158 before activating the motor 128.
* * * * *