INFUSION OF DRUGS

Abstract

An at least partly implantable system for injecting a substance into the body of a patient is disclosed. The system comprises at least one infusion needle disposed at least partly within at least one housing with a tip end of the infusion needle arranged for penetrating an outer wall of the housing. The system further comprises at least one drive unit adapted to be implanted inside the body and a for advancing and retracting the tip end of the infusion needle so that the infusion needle penetrates, upon advancement, the outer wall to allow for injection of the substance.

Claims

1. An at least partly implantable system for injecting a substance into a patient's body, comprising at least one infusion needle (11) disposed at least partly within at least one housing (12) with a tip end (13) of the at least one infusion needle arranged for penetrating the at least one housing's outer wall (15), the at least one housing being adapted for implantation inside a patient's body, and at least one drive unit (D) adapted for implantation inside the patient's body, the at least one drive unit being coupled to the at least one infusion needle and arranged for advancing and retracting the tip end of the at least one infusion needle so that the at least one infusion needle penetrates, upon advancement of the tip end or ends thereof, said outer wall in at least one penetration area (14) so as to allow for injecting the substance through said at least one penetration area via the at least one infusion needle, wherein the drive unit is configured to laterally displace the tip end of at least one of said at least one infusion needle in at least two different lateral directions. SELF-SEALING MATERIAL

2. The system of claim 1, wherein at least in the penetration area or areas the outer wall is made from a material which is self-sealing in respect of penetrations resulting from said at least one infusion needle.

3. The system of claim 2, wherein the self-sealing material forms at least two window areas in said outer wall, said window areas being positioned for penetration by the tip end of the at least one infusion needle.

4. The system of either of claims 2 to 3, wherein the self-sealing material comprises a penetration membrane integrated in the outer wall by being sealingly press-fitted into the outer wall.

5. The system of any of claims 2 to 4, wherein the self-sealing material comprises at least one polymer selected from the group of materials comprising silicon and polyurethane.

6. The system of any of claims 2 to 5, wherein the self-sealing material is made from a composite material.

7. The system of claim 6, wherein the composite material comprises at least one outer shape-giving layer and a self-sealing soft material contained within the outer layer.

8. The system of claim 7, wherein the self-sealing soft material is a gel. FLAPS FORMING THE PENETRATION AREAS

9. The system of claim 1, wherein the outer wall comprises at least one flap in the penetration area or areas through which the at least one infusion needle can pass, said flap being arranged to be pushed aside by the at least one infusion needle upon advancement of said infusion needle. ACTIVELY OPENED WINDOW AREAS

10. The system of claim 1, wherein the outer wall comprises at least one door in the penetration area or areas, wherein a drive is connected to the at least one door for actively opening the door so as to allow for the at least one infusion needle to be advanced through the opened door.

11. The system of claim 10, wherein the drive connected to the door forms part of the drive unit coupled to the infusion needle.

12. The system of either of claims 10 to 11, wherein the door comprises a normally closed, resilient flap.

13. The system of any of claims 10 to 12, comprising at least one spring element urging the door into its closed position.

14. The system of any of claims 1 to 13, wherein at least two penetration areas are arranged in a single one of said at least one housing so that they can be placed either adjacent to both the right and left corpus cavernosum of the patient's penis and/or the two deep arteries of the right and left corpus cavernosum and/or adjacent to muscle tissue regulating blood flow through the right and left corpus cavernosum. NEEDLE

15. The system of any of claims 1 to 14, wherein the at least one infusion needle has a tube-like body closed at the tip end and having a laterally arranged delivery exit port. (Long flexible needles)

16. The system of any of claims 1 to 15, wherein the at least one infusion needle is flexibly bendable, wherein the tip end of each of the at least one infusion needle is arranged for penetrating the outer wall of a first housing and the other end thereof is arranged in a second housing for remote implantation inside the patient's body, the injection needle being sufficiently long to bridge the distance from the second housing for remote implantation to the first housing and further through the first housing up to the outer wall of the first housing.

17. The system of claim 16, wherein at least a part of the drive unit for advancing and retracting the tip end of the infusion needle is contained in the second housing.

18. The system of either of claims 16 to 17, wherein the drive unit for advancing and retracting the infusion needle comprises a screw drive connection.

19. The system of claim 18, wherein the screw drive connection comprises a threading on the infusion needle engaging a fixedly mounted rack.

20. The system of any of claims 16 to 19, wherein the infusion needle is guided in a sheath between the first and second housings. TWO-DIMENSIONAL PENETRATION SITES

21. The system of any of claims 1 to 20, wherein the drive unit is configured to laterally displace the tip end of at least one of said at least one infusion needle in at least two different lateral directions to different penetration sites within said at least one penetration area. TWO PENETRATION AREAS

22. The system of any of claims 1 to 21, wherein the at least one infusion needle (11) is arranged for penetrating the at least one housing's outer wall (15) in at least two different penetration areas (14).

23. The system of claim 22, wherein the system is adapted such that the at least one infusion needle penetrates said at least two different penetration areas upon a single command or single action from the patient.

24. The system of either of claims 22 to 23, wherein the at least one drive unit is adapted for advancing and retracting the tip end of the at least one infusion needle in such way that it penetrates, upon advancement of the tip end or ends thereof, said at least two different penetration areas either simultaneously or in immediate time succession.

25. The system of any of claims 22 to 24, wherein the system is adapted such that the time delay between the penetration of a first and a second of said at least two different penetration areas does not exceed 120 seconds, and preferably does not exceed 60 seconds.

26. The system of any of claims 22 to 25, wherein the system is adapted such that once the at least one infusion needle has been retracted from a first of the at least two different penetration areas, advancement of the at least one infusion needle to a second of the at least two different penetration areas is initiated. NEEDLES and DRIVE UNIT (Plurality of needles)

27. The system of any of claims 22 to 26, wherein a separate infusion needle is provided for each of said at least two different penetration areas. (Two or more needles in common housing)

28. The system of claim 27, wherein at least two infusion needles or the tip ends thereof are contained in a common one of said at least one housing in spaced apart relationship, the drive unit being configured to advance and retract the tip end of a first one of said at least two infusion needles so as to penetrate the outer wall of the common housing in a first one of said at least two different penetration areas and advance and retract the tip end of a second one of said at least two infusion needles so as to penetrate the outer wall of the common housing in a second one of said at least two different penetration areas.

29. The system of claim 28, wherein the drive unit is configured to advance and retract the tip ends of said at least two infusion needles simultaneously.

30. The system of either of claims 28 to 29, wherein the drive unit is configured to laterally displace the tip end of each of said at least two infusion needles to different penetration sites within each of said two different penetration areas.

31. The system of any of claims 28 to 30, wherein the drive unit is configured to displace the tip end of each of said at least two infusion needles in at least two different lateral directions.

32. The system of any of claims 28 to 31, wherein the drive unit is configured to displace the tip end of each of said at least two infusion needles along a three-dimensional array of penetration sites.

33. The system of either of claims 30 to 32, wherein the drive unit is configured to laterally displace the tip ends of the infusion needles simultaneously. (Single needle)

34. The system of any of claims 22 to 26, wherein the drive unit is configured to laterally displace the tip end of one infusion needle of said at least one infusion needle between two lateral positions such that said one infusion needle can penetrate the housing's outer wall in said at least two different penetration areas.

35. The system of claim 34, wherein the drive unit is configured to laterally displace the tip end of said one infusion needle to different penetration sites within each of said at least two different penetration areas.

36. The system of claim 35, wherein the drive unit is configured to displace the tip end of said one infusion needle within each of said at least two different penetration area in said at least two different lateral directions.

37. The system of any of claims 34 to 36, wherein the drive unit is configured to displace the tip end of said one infusion needle within each of said at least two different penetration area along a three-dimensional array of penetration sites.

38. The system of either of claims 35 to 36, wherein a direction of lateral displacement of the tip end of said one infusion needle within each of said at least two different penetration areas is different from, in particular perpendicular to, the direction of lateral displacement of the tip end of the infusion needle between said different penetration areas.

39. The system of claim 38, wherein a direction of lateral displacement of the tip end of said one infusion needle within each of said at least two different penetration areas is the same as the direction of lateral displacement of the tip end of the infusion needle between said different penetration areas. (Manner of needle displacement)

40. The system of any of claims 1 to 39, wherein the drive unit is configured such that said lateral displacement of the tip end of the at least one infusion needle is achieved automatically during advancement and/or retraction of the tip end of the at least one infusion needle.

41. The system of any of claims 1 to 40, wherein the drive unit comprises a movable carriage on which the at least one infusion needle is mounted for lateral displacement of the tip end of the at least one infusion needle.

42. The system of claim 41, wherein the movable carriage comprises a turntable.

43. The system of either of claims 41 to 43, wherein the movable carriage comprises a shuttle.

44. The system of claim 43, wherein the shuttle is in the form of a slide.

45. The system of any of claims 41 to 44, wherein the drive unit comprises a stepper adapted to automatically advance the movable carriage a predefined distance upon each advancement and/or retraction of the infusion needle. RESERVOIR

46. The system of any of claims 1 to 45, further comprising at least one reservoir (R.sub.1, R.sub.2) adapted for implantation inside the patient's body in fluid connection with the at least one infusion needle to supply to the infusion needle the substance to be injected into the patient's body.

47. The system of claim 46, wherein the reservoir comprises at least one first compartment accommodating or adapted to accommodate a first substance and at least one second compartment accommodating or adapted to accommodate a second substance.

48. The system of claim 47, wherein the at least one first compartment accommodates or is adapted to accommodate an infusion liquid and the at least one second compartment accommodates or is adapted to accommodate a drug for mixing with the infusion liquid of the first compartment.

49. The system of claim 48, wherein the drug contained in the at least one second compartment is a drug for stimulating penis erection.

50. The system of any of claims 47 to 49, further comprising a mixing chamber for mixing the substance from the at least one first compartment with the substance from one or more of the at least one second compartment.

51. The system of any of claims 47 to 50, wherein the substance contained in the at least one second compartment is in powder form.

52. The system of any of claims 47 to 51, wherein the substance contained in the at least one second compartment is in freeze-dried form.

53. The system of any of claims 47 to 52, wherein the number of the second compartments is 50 or more, in particular 100 or more.

54. The system of any of claims 47 to 53, wherein a plurality of the second compartments is liquid-tightly sealed against the at least one first compartment, wherein the system further comprises a mechanism for individually opening a connection between the second compartments and the at least one first compartment.

55. The system of claim 54, wherein the second compartments are mounted so as to open towards a first side of a plate and wherein the opening mechanism is adapted to act on the second compartments so as to open to said first side of the plate.

56. The system of claim 55, wherein the second compartments are mounted in the plate as displaceable drug containers and the opening mechanism is adapted to displace the drug containers such that they deliver their drug contents.

57. The system of claim 54, wherein the second compartments are mounted in a plate which is rotatable so as to allow the drug containers to be brought into alignment with a conduit upon rotation of the plate.

58. The system of claim 54, wherein the second compartments are mounted on a tape wound up on a reel.

59. The system of claim 58, wherein the tape is contained in a replaceable cassette.

60. The system of either of claims 56 to 59, wherein a plurality of second compartments is arranged on the tape in side-by-side relationship in a direction different to the winding direction of the tape.

61. The system of any of claims 47 to 60, wherein at least a section of a periphery of the at least one first compartment is made from a flexible material permitting volume changes of the first compartment by deformation of the flexible material as infusion liquid is filled into or drawn out of the at least one first reservoir.

62. The system of claim 61, wherein the flexible material comprises a polymer membrane.

63. The system of claim 62, wherein drawing infusion liquid from the at least one first compartment causes a negative pressure in at least part of the reservoir.

64. The system of claim 63, wherein the at least one first compartment comprises a gas chamber and an infusion liquid chamber, said chambers being separated by the polymer membrane.

65. The system of any of claims 46 to 64, wherein the reservoir has an injection port for refilling the reservoir with infusion liquid.

66. The system of claim 65, wherein the injection port comprises a material which is self-sealing in respect of penetrations caused by a replenishing needle.

67. The system of either of claims 65 to 66, wherein the injection port is adapted for subcutaneous implantation.

68. The system of any of claims 46 to 67, wherein the reservoir is adapted for implantation inside the patient's body remote from the housing. CONDUIT

69. The system of claim 68, comprising at least one conduit for connecting the reservoir with the at least one infusion needle.

70. The system of claim 69, wherein the at least one conduit has a length sufficient to bridge the distance between the patient's symphyseal bone and the inferior fascia of the patient's urogenital diaphragm.

71. The system of claim 70, wherein the at least one conduit has a length of 10 cm or more.

72. The system of any of claims 68 to 71, wherein, where a plurality of infusion needles is provided, separate conduits are provided between each of the infusion needles and the reservoir. COOLING DEVICE

73. The system of any of claims 46 to 72, further comprising a cooling device for keeping the content within at least one compartment of the reservoir at a temperature below 37? C.

74. The system of claim 73, wherein the reservoir or the at least one compartment thereof is comprised in an insulation chamber.

75. The system of either of claims 73 to 74, further comprising a heat exchanger for exchanging heat generated by the cooling device with the patient's body.

76. The system of claim 75, wherein the heat exchanger is adapted for implantation within the patient's body remote from the cooling device and is connected to the cooling device via fluid lines for conducting a heat exchange fluid.

77. The system of any of claims 73 to 76, wherein the cooling device contains at least two different chemicals reacting with each other, thereby consuming thermal energy.

78. The system of claim 77, wherein the at least two chemicals are provided in separate chambers, the system further comprising a flow control device for bringing together certain amounts of the different chemicals.

79. The system of any of claims 73 to 76, wherein the cooling device comprises at least one Peltier element.

80. The system of any of claims 73 to 76, wherein the cooling device is of a refrigerator-type construction. PUMP

81. The system of any of claims 46 to 80, further comprising at least one pump (P) adapted for implantation inside the patient's body to advance the substance from the reservoir to the at least one infusion device.

82. The system of claim 81, wherein the pump is adapted for remote implantation within the patient's body separate from the housing within which the tip end of the infusion needle is contained. MANUAL OPERATION

83. The system of either of claims 46 to 82, wherein actuating means are provided for direct manual operation of the pump and/or the drive unit.

84. The system of claim 83, wherein the actuating means are arranged for directly actuating either the pump or the drive unit, thereby simultaneously indirectly actuating the other, i.e. the drive unit or the pump. DRIVE UNIT

85. The system of any of claims 1 to 84, wherein the at least one drive unit comprises a mechanical drive element for transmitting kinetic energy from a remote location within the patient's body to the at least one infusion needle.

86. The system of claim 85, wherein the mechanical drive element comprises at least one rotating shaft directly or indirectly cooperating with the infusion needle so as to cause movement of the infusion needle upon rotation of the rotating shaft.

87. The system of claim 86, wherein the rotating shaft is in the form of a worm screw.

88. The system of either of claims 86 to 87, wherein the rotating shaft is flexibly bendable.

89. The system of any of claims 86 to 88, including claim 69, wherein the rotating shaft extends through the conduit connecting the at least one infusion needle with the at least one reservoir.

90. The system of any of claims 86 to 89, wherein turning the rotating shaft about its rotating axis causes the tip end of the at least one infusion needle to displace laterally from a first to a second of said at least two different penetration areas and/or from a first penetration site to a second penetration site within a single one of said at least two different penetration areas.

91. The system of any of claims 86 to 90, wherein turning the rotating shaft about its axis of rotation causes the infusion needle to advance and/or retract.

92. The system of any of claims 85 to 91, wherein the mechanical drive element comprises at least one wire directly or indirectly cooperating with the infusion needle so as to cause movement of the needle upon actuation of the wire.

93. The system of claim 92, including claim 69, wherein the at least one wire extends through the conduit connecting the at least one infusion needle with the at least one reservoir.

94. The system of either of claims 92 to 93, wherein pulling at least one of the at least one wire causes the tip end of the at least one infusion needle to displace laterally from a first to a second of said at least two different penetration areas and/or from a first penetration site to a second penetration site within a single one of said at least two different penetration areas.

95. The system of claim 94, wherein at least two, preferably three, pulling wires are provided and arranged for allowing a two-dimensional lateral displacement of the tip end of the infusion needle.

96. The system of any of claims 92 to 95, wherein pulling at least one of the at least one wire causes the infusion needle to advance or retract.

97. The system of any of claims 1 to 96, wherein the at least one drive unit comprises a hydraulic drive for transmitting hydraulic energy from a remote location within the patient's body to the at least one infusion needle for advancing the tip end of the infusion needle.

98. The system of claim 97, including claim 69 wherein hydraulic fluid of the hydraulic drive is guided through the conduit connecting the at least one infusion needle with the at least one reservoir.

99. The system of claim 98, wherein the system is adapted to use as the hydraulic fluid infusion liquid to be injected into the patient's body.

100. The system of claim 98, wherein the system is adapted to use as the hydraulic fluid a secondary liquid different from an infusion liquid to be injected into the patient's body.

101. The system of any of claims 1 to 100, wherein the at least one drive unit comprises as a drive at least one electric motor inside the housing accommodating the at least one infusion needle.

102. The system of claim 101, further comprising wiring for transmitting electric energy from a remote location within the patient's body to the at least one motor.

103. The system of claim 102, including claim 69, wherein the wiring is guided through the conduit connecting the at least one infusion needle with the at least one reservoir.

104. The system of any of claims 1 to 103, wherein the at least one drive unit comprises an electromagnetic drive.

105. The system of claim 104, wherein the electromagnetic drive comprises a group of electromagnets, said electromagnets comprising a plurality of laterally spaced apart electromagnet first parts and at least one electromagnet second part cooperating with an energized one or more than one of the electromagnet first parts, the electromagnet second part being fixedly connected to the at least one infusion needle.

106. The system of claim 105, wherein at least some of the plurality of electromagnet first parts are arranged in a first plane and the electromagnet second part is movable in front of or behind the first plane.

107. The system of claim 105, wherein the plurality of electromagnet first parts are arranged so as to face each other, thereby defining a first plane, and the electromagnet second part is movable within the first plane.

108. The system of any of claims 105 to 107, wherein the electromagnet first parts each include a magnetic coil.

109. The system of any of claims 85 to 108, wherein the drive of the at least one drive unit is arranged for advancing and/or retracting the tip end of the infusion needle.

110. The system of any of claims 85 to 109, wherein the drive of the at least one drive unit is arranged for displacing the tip end of the infusion needle in at least one lateral direction.

111. The system of claim 110, wherein the drive of the at least one drive unit is arranged for displacing the tip end of the infusion needle in two or more lateral directions.

112. The system of claim 110, wherein the drive of the at least one drive unit is arranged for displacing the tip end of the infusion needle in at least one lateral direction and for advancing and retracting the infusion needle.

113. The system of claim 110, wherein the drive of the at least one drive unit is arranged for displacing the tip end of the infusion needle in two or more lateral directions and for advancing and retracting the infusion needle. MOTOR

114. The system of any of claims 1 to 113, wherein at least one motor (M, M.sub.2) is provided for actuating at least one of the pump (P) of claim 81, the drive unit (D) and any other implantable energy consuming part of the system.

115. The system of claim 114, wherein the at least one motor is arranged for actuating either the pump or the drive unit, thereby simultaneously indirectly actuating the other, i.e. the drive unit or the pump.

116. The system of either of claims 114 to 115, wherein activating means are provided for direct manual operation by the patient thereby setting into operation the at least one motor.

117. The system of claim 116, wherein said activating means comprise a pressure sensitive switch so as to be manually operable by the patient when the switch is implanted subcutaneously in a patient's body.

118. The system of any of claims 114 to 117, wherein the at least one motor is adapted for remote implantation within the patient's body separate from the housing within which the tip end of the infusion needle is contained.

119. The system of any of claims 114 to 118, wherein separate motors are provided for separate functions of the system. ENERGY SUPPLY

120. The system of any of claims 1 to 119, wherein coupling elements are provided for conductive energy transfer from outside the patient's body directly or indirectly to the at least one motor, as defined in any of claims 114 to 119, or to any other energy consuming part of the system.

121. The system of any of claims 1 to 120, wherein coupling elements are provided for wireless energy transfer from outside the patient's body directly or indirectly to the at least one motor, as defined in any of claims 114 to 119, or to any other energy consuming part of the system. ENERGY SOURCE

122. The system of any of claims 1 to 121, further comprising an energy source (E) for providing energy to at least one of the pump of claim 81, the drive unit and the motor of claim 114, and any other energy consuming part of the system.

123. The system of claim 122, wherein the energy source is separate from the housing for remote implantation within a patient's body.

124. The system of either of claims 122 to 123, wherein the energy source comprises energy storage means for long term storage of energy.

125. The system of any of claims 122 to 124, wherein the system comprises coupling elements for conductive energy transfer from outside the patient's body to the energy storage means for charging the energy storage means from outside a patient's body, when the energy storage means is implanted in a patient's body.

126. The system of any of claims 122 to 125, wherein the system comprises coupling elements (T) for wireless energy transfer from outside the patient's body to the energy storage means for charging the energy storage means from outside a patient's body, when the energy storage means is implanted in a patient's body. CONTROL UNIT

127. The system of any of claims 1 to 126, wherein at least one control unit (C) is provided for controlling an amount of the substance to be infused into the patient's body via the at least one injection needle.

128. The system of any of claims 1 to 127, wherein a control unit (C) is provided for controlling at least one of the pump of claim 81, the drive unit and the motor of claim 114, any other energy consuming part of the system and, where the system includes an internal or external energy source, said energy source.

129. The system of either of claims 127 to 128, wherein the control unit is separate from the housing for remote implantation within a patient's body.

130. The system of any of claims 127 to 129, wherein the system has a data transfer port for data transfer between an external data processing device and the control unit.

131. The system of claim 130, wherein the data transfer port is a wireless data transfer port for the data transfer.

132. The system of any of claims 127 to 131, wherein the control unit is programmable.

133. The system of any of claims 127 to 132, wherein the control unit comprises an external component for wireless remote control from outside the patient's body.

134. The system of claim 133, wherein the external component of the control unit is adapted for manual operation by the patient for setting into operation the control unit.

135. The system of any of claims 127 to 133, wherein activating means are provided for direct manual operation by the patient for setting into operation the control unit.

136. The system of claim 135, wherein said activating means comprise a pressure sensitive switch so as to be manually operable by the patient when the switch is implanted subcutaneously in a patient's body. FEEDBACK

137. The system of any of claims 1 to 136, wherein at least one feedback sensor (F) is provided and adapted to sense one or more physical parameters of the patient and/or process parameters of the system.

138. The system according claim 137, wherein the at least one feedback sensor is adapted to sense one or more parameters of a group of parameters relating to: drug level, flow volume in a blood vessel.

139. The system of either of claims 137 to 138, wherein the at least one feedback sensor is adapted to sense one or more parameters of the group of parameters comprising: pressure, electrical parameters, distension, distance.

140. The system of any of claims 137 to 139, wherein the at least one feedback sensor is connected to the control unit as defined in any of claims 127 to 136.

141. The system according claim 140, including claim 114, further comprising a control program for controlling the at least one motor in response to one or more signals from the at least one feedback sensor.

142. The system of either of claims 140 to 141, including claim 126, comprising a feedback subsystem adapted to wirelessly send feedback information relating to the energy to be stored in the energy storage means from inside the human body to the outside thereof, wherein the system is adapted to use the feedback information for adjusting the amount of wireless energy transmitted by the energy transmitter.

143. The system of claim 142, wherein the feedback information relates to an energy balance which is defined as the balance between an amount of wireless energy received inside the human body and an amount of energy consumed by the at least one energy consuming part.

144. The system of claim 142, wherein the feedback information relates to an energy balance which is defined as the balance between a rate of wireless energy received inside the human body and a rate of energy consumed by the at least one energy consuming part. INJECTION INTO TUBE

145. The system of any of claims 1 to 144, further comprising at least one tube for injecting thereinto the substance to be injected by means of the at least one injection needle.

146. The system of claim 145, wherein the exit end of the tube has an open area sufficiently large to prevent growth of fibrosis from spanning over the open area.

147. The system of either of claims 145 to 146, wherein the open area has an opening width of 3 mm or more.

148. The system of any of claims 146 to 147, wherein the length of the tube is between 4 mm and 30 mm. METHOD OF IMPLANTATION

149. A method of treating a human being or an animal by implanting at least part of the system of any of claims 1 to 148 in a patient's body, comprising the steps of cutting the skin, dissecting free at least one area within the patient's body, placing the at least one housing accommodating the at least one infusion needle within said dissected area such that the tip end of the at least one infusion needle, when penetrating the housing's outer wall, can penetrate into the patient's tissue so as to allow for injecting a substance via the at least one infusion needle, and closing at least the skin after implantation of at least parts of the system.

150. The method of claim 149, wherein the housing is placed such that the at least one infusion needle penetrates, when penetrating the housing's outer wall, into the left and right corpus cavernosum and/or the two deep arteries of the right and left corpus cavernosum and/or into muscle tissue regulating blood flow through the patient's left and right corpus cavernosum and/or into another kind of tissue in close proximity to the patient's left and right corpus cavernosum.

151. The method of claim 150, comprising the step of securing the corpus cavernosum to the housing by means of a holder connected to the housing.

152. The method of any of claims 149 to 151, comprising the further steps of dissecting free a second area remote from the first area and placing the at least one reservoir in the patient's body in the remote second area, with a conduit connecting the reservoir with the at least one infusion needle accommodated in the at least one housing.

153. The method of claim 152, wherein the reservoir is placed adjacent the patient's symphyseal bone.

154. The method of any of claims 149 to 153, further comprising the steps of placing one or more of the following elements within the patient's body remote from the housing accommodating the at least one needle: at least part of the drive unit D), a reservoir, a pump (P), at least one motor (M, M.sub.2) for actuation of the drive unit (D) or a drive driving the drive unit, and/or the pump (P) or any other energy consuming part of the system, energy storage means (A) for providing the at least one motor with energy, galvanic coupling elements between either an external energy source (E) or the energy storage means (A) and the motor (M, M.sub.2) for transmitting energy to the motor in contacting fashion, wireless coupling elements adapted to connect either the motor (M, M.sub.2) or the energy storage means (A) or both to an extracorporal primary energy source for transmitting energy to either the motor or the energy storage means or both in non-contacting fashion, a control unit (C.sub.1) for controlling the motor (M, M.sub.2), a data transmission interface for wirelessly transmitting data from an external data processing device (C.sub.2) to the control unit (C.sub.1), a feedback sensor (F), wireless energy transforming means, an injection port for refilling the reservoir (R.sub.1), and at least one tube for injecting thereinto a substance to be injected by means of the at least one injection needle. REPLENISHMENT OF RESERVOIR

155. A method of treating a human being or an animal by means of the system of any of claims 1 to 148, comprising the step of replenishing the implanted reservoir (R.sub.1) by penetrating a replenishing needle through the patient's skin and injecting infusion liquid through the replenishing needle directly or indirectly into the reservoir. METHOD OF USE

156. A method of treating a patient by means of the system of any of claims 1 to 148, with the at least one housing accommodating the at least one infusion needle being implanted in the patient's body, comprising the steps of: advancing the tip end of the at least one infusion needle through the at least one housing's outer wall in at least one penetration area thereof, delivering the substance through the advanced tip end of the infusion needle into the patient's body, retracting the tip end of the at least one infusion needle, and laterally displacing the tip end of at least one of the at least one infusion needle for variation of an injection site, wherein upon successive lateral displacements of the tip end of said at least one infusion needle, said tip end is displaced in at least two different lateral directions to different penetration sites.

157. The method of claim 156, comprising the steps of: advancing the tip end of the at least one infusion needle through the at least one housing's outer wall in two different penetration areas either simultaneously or in succession, delivering the substance through the advanced tip end of the infusion needle into the patient's body, and retracting the tip end of the at least one infusion needle, whenever stimulation of penis erection is desired.

158. The method of either of claims 156 to 157, further comprising the step of laterally moving the tip end of the at least one infusion needle in at least two different lateral directions to different penetration sites within at least one penetration area.

159. The method of any of claims 156 to 158, further comprising the step of laterally moving the tip end of the at least one infusion needle between two different penetration areas.

160. The method of any of claims 156 to 159, wherein said at least one housing is implanted adjacent the patient's left and right corpus cavernosum and/or the two deep arteries of the right and left corpus cavernosum and/or adjacent the patient's muscle tissue regulating blood flow through the patient's left and right corpus cavernosum.

161. The method of any of claims 156 to 160, comprising the step of directly or indirectly controlling at least one element of the system from outside the patient's body by means of an extracorporal data processing device.

162. The method of any of claims 156 to 161, comprising the step of directly or indirectly controlling at least one element of the system from inside the patient's body by means of an implanted control unit.

163. The method of claim 162, comprising the step of transferring data between an external data processing device and a data transfer port of the control unit.

164. The method of claim 163, comprising the step of programming the control unit via the data transfer port.

165. The method of either of claims 163 to 164, comprising transferring feedback data from the control unit to the external data processing device.

166. The method of any of claims 163 to 165, comprising the steps of transferring a feedback signal from a feedback sensor to the control unit, and controlling the system in relation to the feedback signal.

167. The method of any of claims 163 to 166, comprising the steps of transferring a feedback signal from a feedback sensor to the control unit, transferring feedback data from the control unit to an external data processing device, and programming the control unit by means of the external data processing device in relation to the feedback data.

168. The method of any of claims 165 to 167, wherein the feedback signal comprises feedback information relating to wireless energy to be stored in an energy storage means, further comprising the step of adjusting the amount of wireless energy transmitted by an energy transmitter in relation to the feedback information.

169. The method of claim 168, wherein the feedback information relates to an energy balance which is defined as the balance between an amount of wireless energy received inside the human body and an amount of energy consumed by the at least one energy consuming part.

170. The method of claim 168, wherein the feedback information relates to an energy balance which is defined as the balance between a rate of wireless energy received inside the human body and a rate of energy consumed by the at least one energy consuming part.

171. The method of any of claims 156 to 170, comprising the steps of mixing a first substance from a first compartment of a reservoir with a second substance from one or more second compartments of the reservoir in a mixing chamber of the system to obtain the infusion liquid to be injected.

172. The method of claim 171, wherein the first substance is an infusion liquid and the second substance is a drug.

173. The method of either of claims 171 to 172, wherein the second substance provided in the second compartments is in powder form.

174. The method of any of claims 171 to 173, wherein the second substance provided in the second compartments is freeze-dried.

175. The method of any of claims 171 to 174, further comprising the step of individually opening a connection between the second compartments and the first compartment whenever the second substance is to be injected into the patient's body.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0076] FIG. 1 shows the muscles of the perineum,

[0077] FIG. 2 shows a cross-section through the penis,

[0078] FIG. 3 shows a top view of a first embodiment of the invention including a single needle,

[0079] FIG. 4 shows a top view of a second embodiment of the invention including a single needle and a motor accommodated in a common housing,

[0080] FIG. 5 shows a top view of a third embodiment of the invention including two needles in a common housing,

[0081] FIG. 6 shows a plan view of a part of the infusion device of FIGS. 4 and 5,

[0082] FIG. 7 shows a cross-sectional view through a penetration membrane made from a composite material,

[0083] FIG. 8 shows a cross-sectional view through the outer wall with flaps in the penetration area,

[0084] FIG. 9 shows a cross-sectional view through the outer wall with an actively openable door in the penetration area,

[0085] FIG. 10 shows a cross-sectional view through the outer wall with an actively openable door according to another embodiment,

[0086] FIG. 11 shows a side view of a fourth embodiment of the invention comprising a single needle which is laterally and vertically displaceable,

[0087] FIG. 12 shows a side view of a fifth embodiment of the invention similar to the fourth embodiment, but with more steps for laterally displacing the needle,

[0088] FIG. 13 shows a sixth, spherical embodiment of the invention for obtaining a three-dimensional array of penetration sites,

[0089] FIG. 14 shows a side view of a seventh embodiment of the invention comprising two needles in a common housing which are laterally and vertically displaceable,

[0090] FIG. 15 shows an eighth embodiment with a principle of advancing and retracting an infusion needle by means of a pull wire,

[0091] FIG. 16 shows a ninth embodiment with a principle of laterally displacing an infusion needle by means of pull wires,

[0092] FIG. 17 shows a tenth embodiment with a principle of advancing and retracting a needle and laterally displacing a needle by means of rotating shafts,

[0093] FIG. 18 shows the overall system of the invention implanted in a patient's body according to a first variation,

[0094] FIG. 19 shows the overall system of the invention implanted in the patient's body according to a second variation,

[0095] FIG. 20 shows the overall system of the invention implanted in the patient's body according to a third variation,

[0096] FIG. 21 shows drug compartments as part of the reservoir of the system according to a first principle,

[0097] FIG. 22 shows drug compartments mounted on a tape wound on a reel in a replaceable cassette as part of the reservoir of the system according to a second principle,

[0098] FIG. 23 shows a part of the tape of FIG. 28 in greater detail,

[0099] FIG. 24 shows the principle of operation of the replaceable cassette of FIG. 22,

[0100] FIG. 25 shows drug compartments as part of the reservoir of the system according to a third principle,

[0101] FIG. 26 shows a cross-sectional view of the drug compartments of FIG. 25 including an insulation chamber and cooling device,

[0102] FIG. 27 shows the principle of the cooling device of FIG. 26 in combination with a heat exchanger,

[0103] FIG. 28 shows a specific embodiment for the cooling device of FIG. 26,

[0104] FIG. 29 shows a part of the system implanted in the patient's body comprising separate needles for the right and the left corpus cavernosum,

[0105] FIG. 30 diagrammatically shows the system of FIG. 29,

[0106] FIG. 31 shows a part of the system of FIG. 30, including a tube into which the needle can be advanced,

[0107] FIGS. 32A to 32C show a first and second embodiment for electromagnetically displacing the infusion needle in a plurality of lateral directions, and

[0108] FIGS. 33A and 33B show a third embodiment for electromagnetically displacing the infusion needle in a plurality of lateral directions.

DETAILED DESCRIPTION OF THE DRAWINGS

[0109] FIG. 1 shows the muscles of the perineum of a male. Reference numerals 1, 2 and 3 designate the ischiocavernosus muscles, bulbospongiosus muscles and superficial transverse perineal muscles, respectively. The bulbospongiosus muscle surrounds lateral aspects of the bulb of the penis at the most proximal part of the body of the penis inserting into the perineal membrane, and further surrounds the dorsal aspect of the corpus spongiosum 4 surrounding the urethra 5 and the left and right corpora cavernosa 6, 7. The ischiocavernosus 1 embraces the crus of the penis, inserting onto the inferior and medial aspects of the crus and to the perineal membrane medial to the crus. While the bulbospongiosus muscle assists the erection by compressing outflow via the deep perineal vein and by pushing blood from the bulb into the body of the penis, the ischiocavernosus muscle 1 maintains erection of the penis by compressing outflow veins and pushing blood from the root of the penis into the body of the penis. FIG. 2 is a cross-sectional view through the penis. As can be seen, the penis is composed of three cylindrical bodies of erectile cavernous tissue: the paired corpora cavernosa 6, 7 dorsally and the single corpus spongiosum ventrally. Deep arteries 9, 10 run distally near the center of the corpora cavernosa, supplying the erectile tissue in these structures. The deep arteries of the penis are the main vessels of the cavernous spaces in the erectile tissue of the corpora cavernosa and are therefore involved in the erection of the penis. They give off numerous branches that open directly into the cavernous spaces. When the penis is flaccid, these arteries are coiled, restricting blood flow.

[0110] For reasons of simplification, the following figures only display the corpora cavernosa 6, 7. FIG. 3 shows a top view of a part of the system according to a first embodiment. More specifically, a single infusion needle 11 is arranged in a housing 12 with a tip end 13 of the needle 11 being positioned such that it can be advanced and retracted through a self-sealing window area 14 in the housing's 12 outer wall 15 in a longitudinal direction 16, so as to pierce the corpus cavernosum 6 or 7 located adjacent the window area 14.

[0111] Two window areas 14 are provided in the outer wall 15 of the housing 12, one adjacent each of the two corpora cavernosa 6, 7. The infusion needle is displaceable in a lateral direction 17 between the two window areas 14 by means of a drive unit D. The same drive unit D or a different drive unit may cause the infusion needle 11 to be advanced and retracted. For this purpose, the infusion needle 11 is mounted on a slide 18 for longitudinal advancement and retraction. A conduit 19 is connected to one end of the infusion needle 11 to supply infusion liquid through the infusion needle 11 to the tip end 13 thereof.

[0112] In operation, the infusion needle 11 will first be advanced with the tip end 13 thereof to penetrate one of the two self-sealing penetration windows 14, injection fluid containing a drug for stimulation of penis erection will be injected into the corpus cavernosum 7 through the infusion needle 11 and, thereafter, the infusion needle 11 will be retracted again. Upon retraction of the infusion needle, the infusion needle will be laterally displaced along the direction 17 so that the tip end 13 thereof comes to lie in front of the other of the two self-sealing window areas 14, the infusion needle 11 will be advanced again so that infusion liquid can be injected through the tip end 13 thereof into the other corpus cavernosum 7 and then the infusion needle 11 will be retracted again. At the end of this procedure, the infusion needle 11 will return to its initial position shown in FIG. 3 or close thereto. The next injection cycle or cycles will occur through penetration sites laterally offset from the penetration sites of the previous injection cycle, as will be explained in more detail in relation to FIGS. 11 and 12.

[0113] The structure of the system shown in FIG. 3 may be purely mechanical. For instance, as will be described in more detail below, the pressure with which the infusion liquid is advanced through the conduit 19 towards the needle 11 may in cooperation with spring elements cause the needle 11 to be advanced, retracted and laterally displaced to the other window area 14. Thus, after two pulses of injection fluid advanced through the conduit 19 towards the needle 11, the needle 11 will automatically return to its starting position shown in FIG. 3 or close thereto.

[0114] However, it is likewise possible to incorporate a motor M or a plurality of motors M within the housing 15 in order to achieve the desired needle displacement by means of the drive unit D. This is schematically shown in FIG. 4. Of course, the motor M will have to be provided with energy and will need to be controlled in an appropriate manner so as to obtain the desired effect. This is not specifically shown in FIG. 4. The energy is preferably transmitted to the motor M from an energy source either remotely implanted inside the patient's body or provided externally of the patient's body.

[0115] The drive D may be configured such that after each penetration cycle (consisting of two injections) the infusion needle 11 stops at a position different from the starting position so that the tip end 13 thereof penetrates the window areas 14 in the next following injection cycle at different sites as compared to the foregoing injection cycle.

[0116] FIG. 5 shows a top view of a third embodiment which differs from the first and second embodiments in that it comprises two infusion needles 11 contained in the housing 15. Thus, when infusion liquid is guided through the conduit 19 towards the two infusion needles 11, both needles are advanced and retracted simultaneously along the direction 16, so that injection of infusion liquid occurs at exactly the same time. The drive unit D or a separate drive unit may be used to turn the turntable 20 on which the infusion needles 11 are mounted, stepwise in the direction 17 so that the window areas 14 will be penetrated by the tip end of the infusion needle 11 at different penetration sites during the next following injection cycle. Again, one or more motors M, not shown in FIG. 5, may be used for driving one or more of the components of the drive unit D. In addition, as will be explained in more detail in relation to FIG. 14, after a number of injection cycles the infusion needle 11 will be displaced laterally upward or downward so that the next number of injection cycles will occur through penetration sites laterally offset from the penetration sites of the previous number of injection cycles.

[0117] The principle of a guide structure for laterally displacing the infusion needle will now be described in context with FIG. 6. Such guide structure may be used e.g. for each of the two infusion needles 11 shown in FIG. 5 or may also be used slightly modified for the lateral displacement of the infusion needle 11 shown in FIGS. 3 and 4.

[0118] The guide structure 28 is securely fixed adjacent the self-sealing window area 14 which itself is implanted adjacent the patient's corpus cavernosum 7. The guide structure 28 comprises a guide pin 27 securely connected to the infusion needle 11 (not shown) such that the infusion needle 11 cooperates with the guide structure 28. Upon advancement or retraction of the infusion needle 11, the guide pin 27 will be guided in the guide structure 28 and thereby laterally displace the infusion needle 11, which lateral displacement causes rotation of the turntable 20 (not shown in FIG. 6). Resilient flaps 28a, 28b within the guide structure 28 serve to guide the guide pin 27 through the entire guide structure 28 upon repeated advancement and retraction of the infusion needle 11. The guide structure 28 is designed to provide different penetration sites through the self-sealing window area 14 into the corpus cavernosum 7. Where it is desired, the trajectory of guide structure 28 may include a return path 28c for the guide pin 27 to return to its starting position shown in FIG. 6. Such return action will be caused by a return spring 29 which is permanently fixed to a rigid part of the housing 15.

[0119] The same structure can likewise be used in the embodiments shown in FIGS. 3 and 4 to displace the single infusion needle 11 laterally between the two window areas 14. Of course, the structure would have to be slightly adapted to accommodate for the larger distance to be overcome between the two window areas 14.

[0120] FIG. 7 shows a preferred embodiment of a penetration membrane to be used as the self-sealing window area 14 in the outer wall 15 of the housing 12. The penetration membrane 30 is made from a composite material. The same material can also be used for other flexible wall portions or for an infusion port that will be described below in connection with another embodiment. The composite material of penetration membrane 30 shown in FIG. 7 comprises an outer shape-giving layer 30a defining a volume in which a self-sealing soft material 30b is contained. Self-sealing soft material 30b can be of gel type having a viscosity such that it does not flow through any penetrations caused by the infusion needle 11 during penetration of the outer shape-giving layer 30a. Instead of a single outer shape-giving layer 30a, the shape-giving layer 30a may comprise a plurality of layers. The outer shape-giving layer 30a preferably comprises silicone and/or polyurethane, since such materials can be produced to have self-sealing properties in respect of penetrations resulting from the infusion needle 11.

[0121] Instead of a self-sealing membrane, the window area 14 in the outer wall 15 of the housing 12 may be formed by one or more flaps, as shown in FIG. 8. Two flaps 30 being made from a resilient, biocompatible material are arranged so as to form a slit which is normally closed and through which the infusion needle 11 can pass when it is advanced. Upon advancement of the infusion needle 11, the needle will push aside the normally closed flaps 30, and when the needle 11 is retracted again, the flaps 30 will return to their normally closed position so as to form a seal against ingression of body liquid.

[0122] FIG. 9 shows a different embodiment. In this case, the self-sealing window 14 in the outer wall 15 comprises a door 30 which can be opened by mechanical action. In the embodiment shown, the door is formed by a flap made from a resilient, biocompatible material which keeps the window area 14 closed in its normal position. A pull wire 300 is attached to one end of the door 30 in order to allow for opening the door by pulling the pull wire 300. The pull wire 300 or any other drive connected to the door 30 forms part of the drive unit coupled to the infusion needle 11. For instance, as is shown in FIG. 10, the pull wire 300 may be attached directly to the infusion needle 11 so that advancement of the infusion needle 11 will simultaneously cause the door 30 to be lifted up so that the infusion needle 11 can pass underneath the door 30 and thus penetrate the outer wall 15 easily. Due to the resiliency of the door material, the door 30 will automatically close when the force, such as the pulling force exerted via the pull wire 300, is released. Instead or in addition, the closing action may be supported by at least one spring element urging the door into its closed position.

[0123] FIG. 11 shows a side view of a fourth embodiment based on the first and second embodiments shown in FIGS. 3 and 4. Accordingly, the single infusion needle 11 is not only laterally displaceable in the direction 17 between the two penetration areas 14 but also laterally displaceable between different penetration sites 21 within the same penetration area 14. More specifically, the direction of lateral displacement of the tip end of the infusion needle 11 within each of said different penetration areas 14 is perpendicular to the direction of lateral displacement between the different penetration areas 14. To achieve this result, the drive unit D is configured to longitudinally advance and retract the infusion needle 11 along a direction 16, to pivot the infusion needle 11 by means of a turntable 20 between the two penetration areas 14 along a pivoting direction 17 and to raise or lower the infusion needle 11 along a third direction 22 perpendicular to the longitudinal direction 16. A suitable purely mechanical construction may perform this function. However, one or more motors may also be provided to perform one and/or the other of these functions.

[0124] FIG. 12 shows a side view of a fifth embodiment similar to the fourth embodiment shown in FIG. 11. In contrast to FIG. 11, the infusion needle 11 is not only laterally displaceable between different penetration sites 21 within the same penetration area 14 in a direction perpendicular to the direction of lateral displacement between the two penetration areas 14, but is also laterally displaceable within the same penetration area 14 in a direction parallel to the direction of lateral displacement between the different penetration areas 14. In other words, the tip end of the infusion needle 11 is laterally displaceable in two dimensions within the same penetration area 14.

[0125] FIG. 13 shows a sixth embodiment which enables the infusion needle 11 to be moved along a three-dimensional, spherically curved array of penetration sites. In this embodiment, a part of the housing 12, more specifically the window area 14, is spherically curved and the needle 11 is mounted in a sphere so that upon rotation of the sphere along the directions 17a and 17b the tip end 13 of the needle 11 can be moved to any position in front of the window area 14. Once an appropriate position has been adjusted for the tip end 13, the needle 11 can be advanced on the slide 18 so as to penetrate the window area 14. Instead of accommodating the slide inside the sphere, it may likewise be mounted on the outer surface of the sphere. Similarly, the infusion needle 11 itself can be mounted on the outer surface of the sphere. The mechanism for moving the sphere along the directions 17a, 17b can be of many different types, such as mechanical by means of rollers or magnetic.

[0126] FIG. 14 shows a seventh embodiment based on the third embodiment shown in FIG. 5. That is, two needles 11 are provided in a common housing so as to be longitudinally movable in order to advance and retract the tip ends thereof through the penetration areas 14. The infusion needles 11 are mounted on a turntable 20, as in the third embodiment of FIG. 5, so as to change the injection sites 22 within a penetration area 14 upon each injection cycle. In addition, the two injection needles can be raised and lowered along a direction 22, similar to the fourth and fifth embodiment described above in relation to FIGS. 11 and 12. Again, the result is that the direction of lateral displacement of the tip ends of the two infusion needles 11 within each of the two different penetration areas 14 is perpendicular to the direction of distance between the two different penetration areas 14. Therefore, in this embodiment as in the fifth embodiment shown in FIG. 12, the tip ends of the two infusion needles 11 are laterally displaceable in two dimensions within the same penetration area 14.

[0127] FIG. 15 shows an eighth embodiment with a principle of advancing and retracting the infusion needle 11 by means of a pull wire 101. The pull wire 101 is redirected about a pin 102 such that by pulling the wire 101 at an end remotely located somewhere in the patient's body the tip end of the infusion needle 11 will be advanced through the window of the housing 12. A helical spring provides a counterforce so that the infusion needle 11 will be retracted once the pulling force on the pull wire 101 is released. This principle can be combined with other embodiments described hereinbefore and hereinafter. Instead of the helical spring 104, a second pull wire may be provided to retract the infusion needle 11. It is even possible to use a single pull wire 101 running around two pins 102 in a loop, so that pulling the wire 101 in the one direction or in the other direction will cause advancement or retraction of the infusion needle 11.

[0128] The pull wire 101 and the conduit 19 for the infusion liquid are guided in a common sheath 103. The common sheath 103 has various functions. First, it gives support to the pull wire 101 in bending sections. Second, it facilitates implantation of the conduit 19 along with the pull wire 101. Third, it protects the pull wire 101 against any build-up of fibrosis.

[0129] FIG. 16 shows a ninth embodiment which involves remotely actuated pull wires 105, 106 guided within a common sheath 103 along with the conduit 19 for the infusion liquid. The pull wires 105 and 106 are directly attached to the infusion needle 11 on opposite sides thereof so that the infusion needle 11 which is mounted on a turntable 20 will be laterally displaced in the one direction or in the other direction depending on whether the wire 105 or the wire 106 is pulled.

[0130] Instead of using two wires 105, 106, one of the wires may be replaced with a pretensioning means, such as the helical spring 104 in FIG. 15. In addition, a further wire, in particular third wire (not shown), may be provided for lateral displacement of the infusion needle 11 in a further direction, so that a two-dimensional lateral displacement can be achieved by pulling the appropriate wires.

[0131] The pull wires may alternatively be attached to an element other than the infusion needle 11, provided that the infusion needle 11 is connected to such other element, so that when the other element is moved or turned by pulling one or more of the wires the tip end of the infusion needle 11 will be displaced accordingly.

[0132] In the case that a long, flexibly bendable needle is provided with the tip end thereof being arranged in a first housing for penetrating the outer wall of the first housing and the other end is arranged in a remotely implanted second housing, one can dispense with the turntable 20 and achieve accurate lateral displacement of the tip end of the needle by pulling the appropriate one of three pull wires which are attached either directly or indirectly to the circumference of the front end of the infusion needle at regularly spaced intervals.

[0133] FIG. 17 shows a tenth embodiment with a different principle of advancing and retracting the tip end of the infusion needle, on the one hand, and laterally displacing the tip end of the infusion needle 11, on the other hand. Instead of pull wires, rotating shafts 107, 108 are provided. The drive for driving the rotating shafts 107, 108 is remotely located somewhere in the patient's body. The front ends of the rotating shafts have a threading 109, 110, e.g. in the form of a worm screw, meshing with the teeth of a rack 111, 112 formed either directly or indirectly on the infusion needle 11 and on the turntable 20, respectively. Thus, by turning the rotating shaft 107, the infusion needle 11 will advance or retract, as the case may be, due to the cooperation of the worm screw 109 and the rack 111. Similarly, by turning the rotating shaft 108, the infusion needle 11 will be displaced laterally in the one or the other direction due to the cooperation of the worm screw 110 and the rack 112 of the turntable 20. Again, the rotating shafts 107, 108 are guided in a common sheath 103 along with the conduit 119 for the infusion liquid.

[0134] In FIGS. 16 and 17, the action of the pull wires 105, 106 and the rotating shaft 108 make it possible to laterally displace the tip end of the infusion needle 11 between two different penetration areas and/or from a first penetration site to a second penetration site within a single penetration area.

[0135] FIG. 18 shows a first variation of an overall system comprising any one of the first to tenth embodiment described above. Specifically shown in the variation shown in FIG. 18 is a housing 12 with a single infusion needle 11 and a drive unit D as described in relation to FIG. 11. The housing 12 is implanted with its windows areas 14 positioned adjacent the corpora cavernosa 6, 7, of which window areas 14 only one is shown in FIG. 18. A motor M is contained in the housing 12 for driving the drive unit D. The motor M within the housing 12 is controlled by means of a control unit C.sub.2 constituting the implantable part of a control system which further comprises an external data processing device C.sub.1 by which commands and any other kind of data can be sent to the control unit C.sub.2. For instance, the external data processing device C.sub.1 may be used to initiate an injection cycle from outside the patient's body, this being done wirelessly as indicated by arrow 23. The implanted control unit C.sub.2 not only controls the motor M inside the housing 12 but also controls the energy supply from an accumulator A to the motor M inside the housing 12.

[0136] The external data processing device C.sub.1 may likewise be used to program the implanted control unit C.sub.2. Also, a data transfer port for transferring data between the external data processing device C.sub.1 and the implanted control unit C.sub.2 may be adapted to transfer data in both directions.

[0137] A feedback sensor F implanted inside the patient's penis is shown here as being connected to the motor M inside the housing 12 and may likewise be connected to the implantable control unit C.sub.2. The feedback sensor F can sense one or more physical parameters of the patient, such as the drug level inside the corpora cavernosa, the flow volume through the corpora cavernosa, the pressure inside the corpora cavernosa and the like. Other feedback sensors may be provided at a different location so as to sense process parameters of the system, such as electrical parameters, distention, distance and the like.

[0138] The conduit 19 connecting the needle 11 with a reservoir comprising compartments R.sub.1 and R.sub.2 and the wiring 24 for transmitting electric energy from the energy source A to the motor M inside the housing 12 are guided through a common conduit 25.

[0139] In the variation of the entire system shown in FIG. 18, the reservoir comprises a first compartment R.sub.1 with e.g. a saline solution included therein, and a second compartment R.sub.2 with e.g. a drug in powder form or freeze-dried form included therein. A pump P driven by a second motor M.sub.2 is arranged to pump infusion liquid from the reservoir R.sub.1 to the infusion needle 11. The infusion liquid pumped by the pump P will pass through a mixing chamber 26 into which drugs will be released from the reservoir R.sub.2 in appropriate time coordination. The motor M.sub.2 or a different motor may cause the drugs to be released from the second reservoir R.sub.2. The motor M.sub.2 is also controlled by the control unit C.sub.2. Thus, infusion liquid pumped via the pump P from the relatively large first reservoir R.sub.1 through the mixing chamber 26, in which it is mixed with the drugs released from the second reservoir R.sub.2, will reach the infusion needle 11 which has meanwhile penetrated the self-sealing window area 14 of the housing 12 and will flow into the corpus cavernosum 7.

[0140] In addition to or instead of the control unit C.sub.2, a pressure sensitive switch for activating the motor M inside the housing 12 and/or the motor M.sub.2 may be arranged subcutaneously.

[0141] Although the embodiment shown in FIG. 18 may comprise one of a great variety of reservoir types, a particular reservoir type will now be described. The volume of the reservoir R.sub.1 is divided into two sections by means of a membrane 31. One section is filled with gas whereas the other section is filled with the infusion liquid (saline solution). An infusion port 32 allows for refilling the reservoir R.sub.1 with infusion liquid by means of a replenishing needle. When the reservoir R.sub.1 is in its full state, the gas section is at ambient pressure or over-pressurized. As infusion liquid is drawn from the reservoir R.sub.1 by means of the pump P upon each infusion cycle, the pressure in the gas section will decrease below ambient pressure, i.e. to a negative relative value. Depending upon the particular type of pump P, it may be advantageous to provide a single acting ball valve to prevent any backflow from the pump P to the reservoir R.sub.1.

[0142] There are various ways of providing the motors M and M.sub.2 with energy. In the variation shown in FIG. 18, energy is supplied from outside the patient's body either for direct use by the motors and/or for charging the accumulator A, which may be in the form of a rechargeable battery and/or a capacitor. An extracorporal primary energy source E transmits energy of a first form through the patient's skin 100 to an energy transforming device T which transforms the energy of the first form into energy of a second form, such as electric energy. The electric energy is used to recharge the accumulator A which provides secondary energy to the motor M upon demand.

[0143] The external primary energy source E may be adapted to create an external field, such as an electromagnetic field, magnetic field or electrical field, or create a wave signal, such as an electromagnetic wave or sound wave signal. For instance, the energy transforming device T as shown in FIG. 19 may act as a solar cell, but adapted to the particular type of wave signal of the primary energy source E. The energy transforming device T may also be adapted to transform temperature changes into electrical energy.

[0144] Instead of the external primary energy source E, an implantable primary energy source E may be used, such as a regular long-life battery instead of the accumulator A.

[0145] The energy signal may also be used to transmit signals from the external data processing device C.sub.1 by appropriate modulation of the energy signal, regardless of whether the energy is transmitted wirelessly or by wire, the energy signal thereby serving as a carrier wave signal for the digital or analog control signal. More particularly, the control signal may be a frequency, phase and/or amplitude modulated signal.

[0146] FIG. 19 shows a second variation of the entire system which basically differs from the system of FIG. 18 only in that the motor M inside the housing 12 is dispensed with. Instead, the motor M.sub.2 is used to drive the drive unit D. This is achieved by means of a rotating shaft 33 in the form of an elastically bendable worm screw, the rotating shaft 30 replacing the wiring 24 of the system shown in FIG. 18.

[0147] FIG. 20 shows a third variation of the entire system which operates purely mechanically. The reservoir R.sub.1 containing the infusion liquid, i.e. the saline solution, is of balloon type, thereby functioning both as a reservoir and as a pump if it is compressed manually from outside the patient's body. The pressure generated in the reservoir R.sub.1 will act on the reservoir R.sub.2 containing the drug. Upon a certain pressure, the drug will be released from the reservoir R.sub.2 into the mixing chamber 26 and upon further increase of the pressure the infusion liquid will be allowed to enter the mixing chamber 26, mix with the drug released from the reservoir R.sub.2, flow towards the infusion needle 11, and build up pressure in the infusion needle 11 such that the drive unit D is caused to advance the infusion needle 11 through the self-sealing window area 14 into the patient's corpus cavernosum. Once the pressure is released, the infusion needle 11 will retract automatically due to mechanical spring forces or the like and move into a different position in which it can penetrate the second of the two self-sealing window areas 14 when the reservoir R.sub.1 is compressed again. Where two infusion needles 11 are provided in the housing 12, a single compressing action on the reservoir R.sub.1 would be sufficient to inject the drug into both the left and right corpora cavernosa.

[0148] FIG. 21 shows a first principle of how drugs within a plurality of compartments 34 of the reservoir R.sub.2 can be released one at a time by a purely hydromechanical solution. As the infusion liquid is urged from the reservoir R.sub.1 towards the conduit 19 leading to the infusion needle or needles, it is first blocked by a spring-loaded ball valve 34 which opens only when a certain pressure is exceeded. The pressure building up in front of the ball valve 34 is guided by means of a stepper valve V sequentially onto one of a plurality of compartments 35. The compartments are each formed as a cavity 35 within a piston 36. Once a certain pressure is exceeded, the piston 36 will be pushed into a position where the compartment 35 is in flow communication with a mixing chamber 26. In the state shown in FIG. 21, three pistons 36 have already been pushed into such position. When the pressure in the reservoir R.sub.1 is further increased, the spring force of the ball valve 34 will be overcome and the infusion liquid urged from the reservoir R.sub.1 towards the conduit 19 will take with it the drug that has been released into the mixing chamber 26.

[0149] FIGS. 22 to 24 show a second principle of realizing the reservoir R.sub.2 comprising a plurality of small drug compartments 35, 35a, 35b. The drug compartments are integrally formed in a tape 201 which is wound on a first reel 202 and can be unwound from said first reel 202 onto a second reel 203. The reels 202, 203 and the tape 201 are contained in a cassette 200 which may be inserted in the entire system so as to form part of the reservoir. The cassette 200 is preferably replaceable.

[0150] As can be seen in FIG. 23, the compartments 35, 35a, 35b containing the drug e.g. in powder form or freeze-dried form are arranged in a plurality of rows as seen in the transporting direction (indicated by the arrow). However, the compartments 35 of one row are a certain distance offset in the transporting direction from the compartments 35a and 35b of the other rows. Thus, when the tape 201 is wound from reel 202 to reel 203, it is guided through a conduit 204 forming part of the cassette 200 through which the infusion liquid is pumped from the reservoir R.sub.1 to the infusion needle or needles, and the compartments 35, 35a, 35b will enter the conduit 204 one after the other.

[0151] While it is conceivable to open one of the compartments 35, 35a, 35b that has entered the conduit 204 by mechanical action, such as a hammer or piercing element, the opening of the compartments 35 in the embodiment shown in FIGS. 22 to 24 needs no further action other than winding the tape 201 onto the reel 203. That is, as can be seen from FIG. 24, when the tape 201 enters the conduit 204 through a first slit 205, the compartments 35 will not be damaged due to the fact that the slit 205 is relatively wide and is closed by two soft sealing lips 206. However, when the tape 201 exits the conduit 204 on the other side thereof, it will have to pass a narrower second slit 207 with front edges 208 that are not resilient. The compartments 35 will therefore burst on their way out of the conduit 204 when they slip between the edges 208 of the narrow slit 207. Soft seals 209 in the slit 207 prevent liquid from leaking from the conduit 204.

[0152] The entry 210 and the exit 211 of the conduit 204 within the cassette 200 each include a valve that automatically closes when the cassette 200 is removed from the system and automatically opens when the cassette 200 is installed in the system. This allows for replacement of the cassette 200 without adversely affecting the remaining components of the overall system.

[0153] FIGS. 25 and 26 show a third principle of realizing the reservoir R.sub.2 comprising a plurality of small drug compartments 35. While FIG. 25 shows a cross-sectional plan view according to section BB in FIG. 26, FIG. 26 shows a cross-sectional side view thereof according to section AA in FIG. 25. The compartments 35 containing the drug in powder form or freeze-dried form are arranged in a rotatable plate 37. A motor M.sub.2 is provided to rotate the plate 37 about an axis 38. The motor M.sub.2 is controlled to advance the plate 37 stepwise so as to bring one compartment 35 at a time in line with the conduit 39 connecting the reservoir R.sub.1 containing the saline solution with the infusion needle or needles. Energy is supplied to the motor M.sub.2 from the accumulator A via the control unit C.sub.1.

[0154] The rotatable plate 37 is mounted in a fixed base plate 39 which itself is fixedly mounted in a housing 40 insulating the base plate 39 and the rotatable plate 37 thermally against an outer housing 42. A cooling device 41 is provided to cool a liquid surrounding the base plate 39 and rotatable plate 37 down to a temperature below 37? C. This serves to protect the drugs inside the compartment 36 from degrading too quickly. The accumulator A supplies the cooling device 41 with energy.

[0155] FIG. 27 shows a general principle of cooling the reservoir R.sub.2 containing the drug to be cooled. The cooling device 41 may be an electrothermal cooler, i.e. based on the Peltier effect consuming electric energy, or may be of the refrigerator type. Accordingly, the cold part of the cooler 41 is placed on the side to be cooled whereas the warm part of the cooling device 41 is placed on the other side so that the heat energy can be dissipated to the outside. An increased surface 41a on the warm side of the cooling device 41 serves to increase heat dissipation. Furthermore, a heat exchanging fluid may be passed through a conduit 41b along the increased surface 41a to transfer the dissipated heat energy to a remote location within the patient's body where the heat is dissipated into the patient's body through a specific heat exchanging surface 41c.

[0156] FIG. 28 shows a different principle of cooling the drugs contained in the reservoir R.sub.2. In this embodiment, two chemicals X1 and X2 are contained separate from each other in respective compartments of the cooling device 41. When the chemicals X1 and X2 are brought together, they will react with each other and such reaction will consume energy which is absorbed as thermal energy from the surroundings. By means of two pistons 41d, 41e, the chemicals X1, X2 are dispensed into a cooling line 41f in a controlled manner, which cooling line is preferably in contact with the housing 40 containing the reservoir R.sub.2. The chemical mixture X1-X2 displaced within the cooling line 41f will flow back into the chamber containing the chemicals X1, X2, but onto the other side of the pistons 41d, 41e.

[0157] A further embodiment is shown in FIG. 29. In this embodiment, again, two separate needles are provided, one needle for each of the left and right corpora cavernosa. However, unlike the previously discussed embodiments, the two needles each have their own housing 12 implanted in the patient's body with their respective self-sealing window area 14 adjacent the left and right corpora cavernosa, respectively. This principle is shown in FIG. 30 in more detail with respect to one of the two needles. The drive unit D comprises a piston 50, to which the hollow infusion needle 11 is attached. The piston 50 separates a first chamber 51a in front of the piston 50 and a second chamber 51b behind the piston 50. While the pressure in the first chamber 51a corresponds to the pressure exerted by the pump P, the pressure in the second chamber 51b can be kept at a lower value. The second chamber 51b may be filled with a liquid, such as the infusion liquid, and the liquid may be urged into a flexible volume 52. The flexible volume 52 could be of simple balloon type so as to fill up without exerting any strong counterforce.

[0158] Instead of the flexible volume 52, a conduit 53 may connect the second chamber 51b with the reservoir R.sub.1. Thus, when the needle 11 is advanced, liquid will be dispelled from the second chamber 51b through the conduit 53 into the reservoir R.sub.1, and as the needle 11 is retracted by means of a return spring 55, liquid will be drawn from the reservoir R.sub.1 through the conduit 53 back into the second chamber 51b.

[0159] The injection process is carried out as follows. As the pressure is increased in the first chamber 51a by means of the pump P, the needle 11 will be displaced against the force of the spring 55 of the drive unit B. Thus, the tip end 13 of the infusion needle 11 will penetrate through the self-sealing window area 14 press-fitted into the wall 15 of the housing 12 and will further penetrate any fibrosis having built up in front of the housing. When the return spring 55 is completely compressed and the pressure built up by the pump P is further increased, a ball valve 56 will be displaced against a second return spring 57 which is stronger than the first return spring 55. That way, as long as the pressure is held at a sufficiently high level, infusion liquid will be pumped from the reservoir R.sub.1 through the conduit 19, the hollow infusion needle 11 and the needle's laterally arranged exit port into the patient's body. Upon pressure release, the ball valve 56 will close due to the return springs 55 and 57, and then the needle 11 will be retracted to its initial position shown in FIG. 21.

[0160] It may be advantageous not to pierce any living tissue by means of the injection needle 11 once it is advanced through the outer wall 15 of the housing 12. Therefore, as shown in FIG. 31, a tube 58 may be placed in front of the window area 14. The cross sectional form of the tube 58 may be adapted to the cross-sectional form of the window area 14, i.e. where the window area 14 is rectangular, the tube 58 likewise has a rectangular cross-section.

[0161] The exit end of the tube 58 has an open area 59 sufficiently large to prevent growth of fibrosis from spanning over the open area. Fibrosis will slowly grow into the tube along the tube's inner surface, before it reaches the window area 14 after a relatively long time. The tip end 13 of the needle 11 will therefore not have to penetrate any fibrosis during the first while after implantation of the system. Preferably, the open area 59 has an opening width of at least 3 mm. The length of the tube 58 may be in the range of 4 mm to 30 mm. The opening width 59 and the length of the tube 58 should be adjusted such that the substance injected into the tube 58 can safely seep into the patient's body. Thus, the longer the tube is, the larger the opening width thereof should be.

[0162] FIGS. 32A and 32B show a first embodiment for displacing the tip end of the infusion needle 11 in two or more different directions, i.e. a two-dimensional displacement. More specifically, FIG. 32A shows a plan view, whereas FIG. 32B shows a side elevational view schematically. As can be seen, a plate 60 to which the infusion needle 11 is fixedly mounted has a projection 61 extending into a frame 62 within which the projection 61 is free to move in any direction. Electromagnetic coils 63 are mounted on the sides of the frame 62 and are individually energizable. The electromagnetic coils 63 constitute the first part of an electromagnetic drive whereas the projection 61 is configured to constitute the second part of the electromagnetic drive. Thus, when one or more of the electromagnetic coils are energized, an electromagnetic field is created in the frame 62 and the electromagnet second part, i.e. the projection 61, will adjust its position within such field accordingly. Due to the fact that the infusion needle 11 is fixedly mounted to the plate 60, the infusion needle 11 will move along with the projection 61. This way, the infusion needle 11 can be advanced and retracted and can also be displaced laterally.

[0163] Of course, the infusion needle 11 may be attached to the electromagnetic drive in a different manner, e.g. perpendicular to the plane defined by the electromagnetic coils 63 (rather than in parallel as in FIG. 32B). As a result, the infusion needle would be laterally displaceable in a plurality of directions (rather than being advanceable and retractable).

[0164] Alternatively, the electromagnetic drive may be such as to displace the infusion needle in any lateral direction and, in addition, to advance and retract the infusion needle. This can be achieved e.g. with a structure as schematically shown in FIG. 32C relating to a second embodiment for displacing the tip end of the infusion needle 11. FIG. 32C shows an elevational side view similar to FIG. 32B, but the electromagnetic coils 63 do not define a single plane, but rather a plurality of planes is defined one above the other by providing additional electromagnetic coils 63 in a vertical direction. The top plan view would be similar to FIG. 32A. This way, the electromagnet second part 61 fixedly connected to the needle 11 moves within a three-dimensional frame 62 depending on the energization of respective ones of the magnetic coils 63.

[0165] FIGS. 33A and 33B shows a plan view and a side view of a third embodiment of an electromagnetic drive for moving the infusion needle 11 in a plurality of directions. In this embodiment, the electromagnetic coils 63 constituting the electromagnet first parts are arranged in a first plane and the electromagnet second part constituted by the protrusion 61 fixedly connected to the infusion needle 11 via the plate 60 is movable in a plane in front of or behind the plane defined by the electromagnet first parts. However, the electromagnetic coils 63 are oriented differently in this third embodiment. Again, depending upon the energization of the individual electromagnetic coils, the electromagnet second part, i.e. the protrusion 61, will adjust its position in the created electromagnetic field within the frame 62.

[0166] A method of treating a human being (or an animal) by implanting at least part of the system in the patient's body comprises the steps of cutting the skin, dissecting free a first area near the left and right corpus cavernosum, placing the at least one housing accommodating the at least one infusion needle within said dissected area such that the tip end of the at least one infusion needle, when penetrating the housing's outer wall, can penetrate into the left and right corpus cavernosum and/or the two deep arteries of the right and left corpus cavernosum and/or into muscle tissue regulating blood flow to the patient's left and right corpus cavernosum and/or into another kind of tissue in close proximity to the patient's left and right corpus cavernosum allowing stimulation of erection of the two corpora cavernosa, and finally closing at least the skin after implantation of at least parts of the system.

[0167] Where parts of the system are implanted remote from the corpora cavernosa, a second area remote from the first area may be dissected free in order to place e.g. the at least one reservoir in the patient's body at the remote second area, with a conduit connecting the reservoir with the at least one infusion needle accommodated in the at least one housing. In this case, it is preferable to place the reservoir adjacent the patient's symphyseal bone.

[0168] One or more of the following elements may be placed within the patient's body remote from the housing or housings accommodating the at least one needle: [0169] a reservoir for supplying to the infusion device a substance to be injected into the patient's body, [0170] a pump (P) for advancing the substance from the reservoir to the at least one infusion needle, [0171] at least one motor (M, M.sub.2) for actuation of the drive unit (D) or a drive driving the drive unit, and/or the pump (P) or any other energy consuming part of the system, [0172] energy storage means (A) for providing the at least one motor with energy, [0173] galvanic coupling elements between either an external energy source (E) or the energy storage means (A) and the motor (M, M.sub.2) for transmitting energy to the motor in contacting fashion, [0174] wireless coupling elements adapted to connect either the motor (M, M.sub.2) or the energy storage means (A) or both to an extracorporal primary energy source for transmitting energy to either the motor or the energy storage means or both in non-contacting fashion, [0175] control unit (C1) for controlling the motor (M, M.sub.2), [0176] a data transmission interface for wirelessly transmitting data from an external data processing device (C.sub.2) to the control unit (C.sub.1), [0177] the feedback sensor (F), [0178] wireless energy transforming means, and [0179] the injection port (32) for refilling the reservoir (R.sub.1).