STIMULATION OF SEXUALLY RESPONSIVE TISSUE OF THE VULVA

• US 20110288499A1
• Filed: 10/09/2009
• Published: 11/24/2011
• Est. Priority Date: 10/10/2008
• Status: Active Grant

• Current Assignee: Kirk Promotion Ltd.
• Original Assignee: Milux Holding SA
• Inventors: Forsell, Peter
• Granted Patent: US 8,926,572 B2
• Time in Patent Office: Days
• US Class Current: 604/272
• CPC Class Codes: A61F 2/26 Penis implants
• CPC Class Codes: A61M 2005/14284 with needle insertion means
• CPC Class Codes: A61M 2205/353 using mechanical means, e.g. subcutaneous pushbuttons
• CPC Class Codes: A61M 2205/3606 cooled
• CPC Class Codes: A61M 2205/3613 by body heat
• CPC Class Codes: A61M 2205/364 by chemical reaction
• CPC Class Codes: A61M 2205/366 by liquid heat exchangers
• CPC Class Codes: A61M 2205/3673 thermo-electric, e.g. Peltier effect, thermocouples, semi-conductors
• CPC Class Codes: A61M 2205/82 Internal energy supply devices
• CPC Class Codes: A61M 2205/8243 by induction
• CPC Class Codes: A61M 2209/045 for filling, e.g. for filling reservoirs
• CPC Class Codes: A61M 2210/1475 Vagina
• CPC Class Codes: A61M 39/0208 Subcutaneous access sites for injecting or removing fluids transcutaneous access sites A61M39/0247; implantable infusion devices A61M5/14276
• CPC Class Codes: A61M 5/1407 Infusion of two or more substances
• CPC Class Codes: A61M 5/14212 Pumping with an aspiration and an expulsion action
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/1428 with manual pumping action
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: A61M 5/44 having means for cooling or heating the devices or media

Abstract

A female external genitalia stimulation system, in particular clitoris erection stimulation system, comprises a fully implantable drug delivery device for delivering a drug in relation to a erectile tissue to achieve erection thereof. The drug delivery device may comprise a catheter adapted to be implanted in the corpora cavernosa of a clitoris or in close proximity thereto in order to deliver drugs through said catheter. Alternatively, one or more infusion needles may be disposed within and implanted along with one or more housings adjacent the patient'"'"'s left and right corpora cavernosa. A reservoir and a pump may also be implanted inside the patient'"'"'s body to supply the infusion needle with infusion liquid. A drive unit also adapted for implantation inside the patient'"'"'s body is arranged for advancing and retracting the tip end of the infusion needle such that it penetrates the housing at least in two different penetration areas either simultaneously or in immediate time succession, thereby injecting drugs along with the infusion liquid into the patient'"'"'s body for stimulating erectile tissue, in particular for stimulating clitoris erection.

Claims

1. A female stimulation system for stimulating sexually responsive tissue of the vulva, in particular an erection or lubrication stimulation system, comprising a fully implantable drug delivery device for delivering a drug in relation to the female'"'"'s sexually responsive tissue of the vulva to achieve sexual stimulation thereof.

2. The system of claim 1, adapted to stimulate an erectile tissue part of the sexually responsive tissue of the vulva to achieve engorgement of blood causing erection of the erectile tissue.

3. The system of claim 1, adapted to stimulate a lubrication part of the sexually responsive tissue of the vulva to achieve lubrication of sexually responsive tissue of the vulva.

4. The system of either of claims 2 to 3, adapted to stimulate the nerval system of the sexually responsive tissue of the vulva to achieve engorgement of blood causing erection of the erectile tissue or to achieve stimulation of the lubrication part of the sexually responsive tissue of the vulva causing lubrication of sexually responsive tissue of the vulva.

5. The system of any of claims 1 to 4, wherein the drug delivery device comprises at least one catheter adapted to be implanted outside the corpora cavernosa in close proximity thereto and wherein the drug delivery device is further adapted to supply drugs through the catheter.

6. The system of any of claims 1 to 4, wherein the drug delivery device comprises at least one catheter adapted to be implanted in at least one corpus cavernosum and wherein the drug delivery device is further adapted to supply drugs into the corpus cavernosum through the catheter.

7. The system of any of claims 1 to 5, wherein the drug delivery device comprises at least one infusion needle adapted to be placed outside the corpora cavernosa in close proximity thereto, and wherein the at least one infusion needle is adapted to change position outside the corpora cavernosa, when the drug delivery device is implanted, and wherein the drug delivery device is further adapted to deliver drugs through the infusion needle outside the corpora cavernosa, when the needle'"'"'s position is changed outside the corpora cavernosa.

8. The system of any of claims 1 to 6, wherein the drug delivery device comprises at least one infusion needle adapted to be placed outside the corpora cavernosa in close proximity thereto, and wherein the infusion needle is adapted to be advanced into and retracted from at least one corpus cavernosum, when the drug delivery device is implanted, and wherein the drug delivery device is further adapted to deliver drugs through the infusion needle into the corpus cavernosum, whenever the needle is advanced into the corpus cavernosum.

Needle

9. The system of either of claims 7 to 8, 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.

Needle in Housing

10. The system of any of claims 7 to 9,

wherein the at least one infusion needle is disposed at least partly within at least one housing with a tip end of the at least one infusion needle arranged for penetrating the at least one housing'"'"'s outer wall, the at least one housing being adapted for implantation inside a patient'"'"'s body, and

wherein at least one drive unit adapted for implantation inside the patient'"'"'s body is provided, the at least one drive unit being coupled to the at least one infusion needle and arranged at least 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 so as to allow for stimulation of erectile tissue by injecting the substance through said at least one penetration area via the at least one infusion needle.

Two-Dimensional Penetration Sites

11. The system of claim 10, 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

12. The system of either of claims 10 to 11, wherein the at least one infusion needle is arranged for penetrating the at least one housing'"'"'s outer wall in at least two different penetration areas.

13. The system of claim 12, 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.

14. The system of either of claims 12 to 13, 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.

15. The system of any of claims 12 to 14, 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.

16. The system of any of claims 12 to 15, 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.

Self-Sealing Material

17. The system of any of claims 10 to 16, 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.

18. The system of claim 17, 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.

19. The system of either of claims 17 to 18, wherein the self-sealing material comprises a penetration membrane integrated in the outer wall by being sealingly press-fitted into the outer wall.

20. The system of any of claims 17 to 19, wherein the self-sealing material comprises at least one polymer selected from the group of materials comprising silicon and polyurethane.

21. The system of any of claims 17 to 20, wherein the self-sealing material is made from a composite material.

22. The system of claim 21, wherein the composite material comprises at least one outer shape-giving layer and a self-sealing soft material contained within the outer layer.

23. The system of claim 22, wherein the self-sealing soft material is a gel.

Flaps Forming the Penetration Areas

24. The system of any of claims 10 to 16, 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

25. The system of any of claims 10 to 116, 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.

26. The system of claim 25, wherein the drive connected to the door forms part of the drive unit coupled to the infusion needle.

27. The system of either of claims 25 to 26, wherein the door comprises a normally closed, resilient flap.

28. The system of any of claims 25 to 27, comprising at least one spring element urging the door into its closed position.

29. The system of any of claims 10 to 28, 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 clitoris 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 and/or regulating blood flow through the bulbs of the vestibule.

Long Flexible Needles

30. The system of any of claims 10 to 21, 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.

31. The system of claim 30, 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.

32. The system of either of claims 30 to 31, wherein the drive unit for advancing and retracting the infusion needle comprises a screw drive connection.

33. The system of claim 32, wherein the screw drive connection comprises a threading on the infusion needle engaging a fixedly mounted rack.

34. The system of any of claims 30 to 33, wherein the infusion needle is guided in a sheath between the first and second housings.

Needles and Drive Unit

(Plurality of Needles)

35. The system of any of claims 10 to 34, wherein a separate one infusion needle is provided for each of at least two different penetration areas.

(Individual Needle for Each Penetration Site)

36. The system of claim 35, wherein two or more infusion needles are provided for each of said two different penetration areas and are arranged for penetrating different penetration sites within each of said two different penetration areas.

37. The system of claim 36, wherein the drive unit is configured to advance and retract one infusion needle in each of said two different penetration areas at one time, and to advance and retract a different infusion needle in each of said two different penetration areas at a different time.

(Two or More Needles in Common Housing/Lateral Needle Displacement)

38. The system of claim 35, 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.

39. The system of claim 38, wherein the drive unit is configured to advance and retract the tip ends of said at least two infusion needles simultaneously.

40. The system of either of claims 38 to 39, wherein the drive unit is configured to laterally displace the tip end of each of said at least two the infusion needles to different penetration sites within each of said two different penetration areas.

41. The system of any of claims 38 to 40, 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.

42. The system of any of claims 38 to 41, wherein the drive unit is configured to displace the tip ends the infusion needles two-dimensionally.

43. The system of any of claims 38 to 42, 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.

44. The system of any of claims 39 to 43, wherein the drive unit is configured to displace the tip ends of the infusion needles along a curved path.

45. The system of either of claims 40 to 44, wherein the drive unit is configured to laterally displace the tip ends of the infusion needles simultaneously.

46. The system of any of claims 40 to 45, wherein a direction of lateral displacement of the tip ends of the infusion needles within each of said two different penetration areas is the same as the direction of distance between said two different penetration areas.

47. The system of any of claims 40 to 46, wherein a direction of lateral displacement of the tip ends of the infusion needles within each of said two different penetration areas is different from, in particular perpendicular to, the direction of distance between said two different penetration areas.

(Single Needle/Lateral Needle Displacement)

48. The system of any of claims 10 to 34, 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 at least two different penetration areas.

49. The system of claim 48, 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 different penetration areas.

50. The system of either of claims 48 to 49, wherein the drive unit is configured to displace the tip end of said one infusion needle in at least two different lateral directions.

51. The system of any of claims 48 to 50, wherein the drive unit is configured to displace the tip end of said one infusion needle two-dimensionally.

52. The system of any of claims 48 to 50, 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.

53. The system of any of claims 48 to 52, wherein the drive unit is configured to displace the tip end of said one infusion needle along a curved path.

54. The system of any of claims 49 to 53, 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.

55. The system of any of claims 49 to 53, wherein a direction of lateral displacement of the tip end of the infusion needle within each of said 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.

(Manner of Needle Displacement)

56. The system of any of claims 40 to 55, 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.

57. The system of any of claims 10 to 56, 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.

58. The system of claim 57, wherein the movable carriage comprises a turntable.

59. The system of either of claims 57 to 58, wherein the movable carriage comprises a shuttle.

60. The system of claim 59, wherein the shuttle is in the form of a slide.

61. The system of any of claims 57 to 60, 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

62. The system of any of claims 1 to 61, further comprising at least one reservoir adapted for implantation inside the patient'"'"'s body to store the drug to be delivered.

63. The system of claim 62, 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.

64. The system of claim 63, 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.

65. The system of claim 64, wherein the drug contained in the at least one second compartment is a drug for stimulating clitoris erection.

66. The system of any of claims 63 to 65, 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.

67. The system of any of claims 63 to 66, wherein the substance contained in the at least one second compartment is in powder form.

68. The system of any of claims 63 to 67, wherein the substance contained in the at least one second compartment is in freeze-dried form.

69. The system of any of claims 63 to 70, wherein the number of the second compartments is 50 or more, in particular 100 or more.

70. The system of any of claims 63 to 71, 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.

71. The system of claim 70, 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.

72. The system of claim 71, 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.

73. The system of claim 70, 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.

74. The system of claim 70, wherein the second compartments are mounted on a tape wound up on a reel.

75. The system of claim 74, wherein the tape is contained in a replaceable cassette.

76. The system of either of claims 72 to 75, 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.

77. The system of any of claims 63 to 76, 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.

78. The system of claim 77, wherein the flexible material comprises a polymer membrane.

79. The system of claim 78, wherein drawing infusion liquid from the at least one first compartment causes a negative pressure in at least part of the reservoir.

80. The system of claim 79, wherein the at least one first compartment comprises a gas chamber and an infusion liquid chamber, said chambers being separated by the polymer membrane.

81. The system of any of claims 62 to 80, wherein the reservoir has an injection port for refilling the reservoir with infusion liquid.

82. The system of claim 81, wherein the injection port comprises a material which is self-sealing in respect of penetrations caused by a replenishing needle.

83. The system of either of claims 81 to 82, wherein the injection port is adapted for subcutaneous implantation.

84. The system of any of claims 62 to 83, wherein the reservoir is adapted for implantation inside the patient'"'"'s body remote from the housing.

Conduit

85. The system of claim 84, including any one of claims 5 to 8, comprising at least one conduit for connecting the reservoir with the at least one catheter or the at least one infusion needle, respectively.

86. The system of claim 85, 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.

87. The system of claim 86, wherein the at least one conduit has a length of 10 cm or more.

88. The system of any of claims 84 to 87, wherein, where a plurality of infusion needles is provided, separate conduits are provided between each of the infusion needles and the reservoir.

Cooling Device

89. The system of any of claims 62 to 88, further comprising a cooling device for keeping the content within at least one compartment of the reservoir at a temperature below 37°

C.

90. The system of claim 89, wherein the reservoir or the at least one compartment thereof is comprised in an insulation chamber.

91. The system of either of claims 89 to 90, further comprising a heat exchanger for exchanging heat generated by the cooling device with the patient'"'"'s body.

92. The system of claim 91, 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.

93. The system of any of claims 89 to 92, wherein the cooling device contains at least two different chemicals reacting with each other, thereby consuming thermal energy.

94. The system of claim 93, 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.

95. The system of any of claims 89 to 92, wherein the cooling device comprises at least one Peltier element.

96. The system of any of claims 89 to 92, wherein the cooling device is of a refrigerator-type construction.

Pump

97. The system of any of claims 62 to 96, further comprising at least one pump (P) adapted for implantation inside the patient'"'"'s body to advance the drug from the reservoir to the at least one drug delivery device.

98. The system of claim 97, 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

99. The system of any of claims 1 to 98, including claim 10 and/or claim 97, wherein actuating means are provided for direct manual operation of the pump of claim 97 and/or the drive unit of claim 10.

100. The system of claim 99, 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

101. The system of any of claims 10 to 100, 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.

102. The system of claim 101, 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.

103. The system of claim 102, wherein the rotating shaft is in the form of a worm screw.

104. The system of either of claims 102 to 103, wherein the rotating shaft is flexibly bendable.

105. The system of any of claims 102 to 104, including claim 85, wherein the rotating shaft extends through the conduit connecting the at least one infusion needle with the at least one reservoir.

106. The system of any of claims 102 to 105, 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.

107. The system of any of claims 102 to 106, wherein turning the rotating shaft about its axis of rotation causes the infusion needle to advance and/or retract.

108. The system of any of claims 101 to 107, 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.

109. The system of claim 108, including claim 85, wherein the at least one wire extends through the conduit connecting the at least one infusion needle with the at least one reservoir.

110. The system of either of claims 108 to 109, 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.

111. The system of claim 110, 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.

112. The system of any of claims 108 to 111, wherein pulling at least one of the at least one wire causes the infusion needle to advance or retract.

113. The system of any of claims 10 to 112, 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.

114. The system of claim 113, including claim 85, 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.

115. The system of claim 114, wherein the system is adapted to use as the hydraulic fluid infusion liquid to be injected into the patient'"'"'s body.

116. The system of claim 114, 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.

117. The system of any of claims 10 to 116, 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.

118. The system of claim 117, further comprising wiring for transmitting electric energy from a remote location within the patient'"'"'s body to the at least one motor.

119. The system of claim 118, including claim 85, wherein the wiring is guided through the conduit connecting the at least one infusion needle with the at least one reservoir.

120. The system of any of claims 10 to 119, wherein the at least one drive unit comprises an electromagnetic drive.

121. The system of claim 120, 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.

122. The system of claim 121, 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.

123. The system of claim 121, 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.

124. The system of any of claims 121 to 123, wherein the electromagnet first parts each include a magnetic coil.

125. The system of any of claims 101 to 124, wherein the drive of the at least one drive unit is arranged for advancing and/or retracting the tip end of the infusion needle.

126. The system of any of claims 101 to 125, 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.

127. The system of claim 126, 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.

128. The system of claim 126, 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.

129. The system of claim 126, 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.

130. The system of any of claims 101 to 129, wherein at least the drive of the drive unit is adapted to be implanted at a location remote from the housing accommodating the infusion needle.

Motor

131. The system of any of claims 1 to 130, wherein at least one motor is provided for actuating at least one of the pump of claim 97, the drive unit (D) of claim 7 and any other implantable energy consuming part of the system.

132. The system of claim 131, 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.

133. The system of either of claims 131 to 132, wherein activating means are provided for direct manual operation by the patient thereby setting into operation the at least one motor.

134. The system of claim 133, 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.

135. The system of any of claims 131 to 134, 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.

136. The system of any of claims 131 to 135, wherein separate motors are provided for separate functions of the system.

Energy Supply

137. The system of any of claims 1 to 136, wherein coupling elements are provided for conductive energy transfer from outside the patient'"'"'s body directly or indirectly to the at least one motor of claim 131 or to any other energy consuming part of the system.

138. The system of any of claims 1 to 137, wherein coupling elements are provided for wireless energy transfer from outside the patient'"'"'s body directly or indirectly to the at least one motor, of claim 131 or to any other energy consuming part of the system.

Energy Source

139. The system of any of claims 1 to 138, further comprising an energy source for providing energy to at least one of the pump of claim 97, the drive unit of claim 10, the motor of claim 131 and any other energy consuming part of the system.

140. The system of claim 139, wherein the energy source comprises an internal power supply for implantation within a patient'"'"'s body remote from the housing accommodating the infusion needle.

141. The system of either of claims 139 to 140, wherein the internal power supply comprises energy storage means for long term storage of energy.

142. The system of claim 141, wherein the energy source comprises an external power supply for charging the energy storage means from outside the patient'"'"'s body.

143. The system of any of claims 139 to 142, wherein the system comprises coupling elements for conductive energy transfer from the external power supply 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.

144. The system of any of claims 139 to 143, wherein the system comprises coupling elements for wireless energy transfer from the external power supply 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

145. The system of any of claims 1 to 144, wherein at least one control unit is provided for controlling an amount of the drug to be delivered into the patient'"'"'s body.

146. The system of any of claims 1 to 145, wherein a control unit is provided for controlling at least one of the pump of claim 97, the drive unit of claim 10, the motor of claim 131, any other energy consuming part of the system and, where the system includes an internal or external energy source, said energy source.

147. The system of either of claims 145 to 146, wherein the control unit is separate from the housing for remote implantation within a patient'"'"'s body.

148. The system of any of claims 145 to 147, wherein the system has a data transfer port for data transfer between an external data processing device and the control unit.

149. The system of claim 148, wherein the data transfer port is a wireless data transfer port for the data transfer.

150. The system of any of claims 145 to 149, wherein the control unit is programmable.

151. The system of any of claims 145 to 150, wherein the control unit comprises an external component for controlling the system from outside the patient'"'"'s body and an implantable control unit adapted to receive a signal from the external control unit.

152. The system of claim 151, wherein the external component is adapted for wireless remote control from outside the patient'"'"'s body.

153. The system of claim 152, wherein the external component of the control unit is adapted for manual operation by the patient for setting into operation the control unit.

154. The system of any of claims 145 to 152, wherein activating means are provided for direct manual operation by the patient for setting into operation the control unit.

155. The system of claim 154, 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

156. The system of any of claims 1 to 157, wherein at least one feedback sensor is provided and adapted to sense one or more physical parameters of the patient and/or process parameters of the system.

157. The system according claim 156, 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.

158. The system of either of claims 156 to 157, 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.

159. The system of any of claims 156 to 158, wherein the at least one feedback sensor is connected to the control unit as defined in any of claims 145 to 155.

160. The system according claim 159, including claim 131, 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.

161. The system of any of claims 1 to 160, including claim 142, comprising a feedback subsystem adapted to send a feedback information signal including information on a parameter related to the charging process from inside the patient'"'"'s body to the external power supply for controlling the charging process.

162. The system of any of claims 159 to 161, wherein the feedback subsystem is adapted to wirelessly send the feedback information.

163. The system of either of claims 161 to 162, 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.

164. The system of either of claims 161 to 162, 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.

165. The system of either of claims 163 to 164, wherein the consumed energy includes the energy that is consumed by the process of charging the implantable power supply.

Injection into Tube

166. The system of any of claims 1 to 165, including claim 10, further comprising at least one tube for injecting thereinto the substance to be injected by means of the at least one injection needle.

167. The system of claim 166, wherein the exit end of the tube has an open area sufficiently large to prevent growth of fibrosis from spanning over the open area.

168. The system of either of claims 166 to 167, wherein the open area has an opening width of 3 mm or more.

169. The system of any of claims 167 to 168, wherein the length of the tube is between 4 mm and 30 mm.

Method of Implantation

170. A method of treating a human being or an animal by implanting at least part of a system according to any one of claims 5 to 169 in a patient'"'"'s body, comprising the steps of

cutting the skin,

dissecting free the left and right corpus cavernosum,

placing the drug delivery device within said dissected area with the a least one catheter ending in the left and right corpus cavernosum and/or the two deep arteries of the right and left corpus cavernosum and/or the bulbs of the vestibule and/or muscle tissue regulating blood flow through the patient'"'"'s left and right corpus cavernosum and/or regulating blood flow through the bulbs of the vestibule, and/or another kind of tissue in close proximity to the clitoris, labia minora and/or bulbs of the vestibule, so as to allow for stimulation of erectile tissue by delivering a drug through said at least one catheter, and

closing at least the skin after implantation of at least parts of the system.

171. A method of treating a human being or an animal by implanting at least part of a system according to any one of claims 6 to 169 in a patient'"'"'s body, comprising the steps of

cutting the skin,

dissecting free an area near the left and right corpus cavernosum,

placing the drug delivery device within said dissected area with the a least one catheter arranged next to the left and right corpus cavernosum and/or next to the two deep arteries of the right and left corpus cavernosum and/or next to the bulbs of the vestibule, so as to allow for stimulation of erectile tissue by delivering a drug through said at least one catheter, and

closing at least the skin after implantation of at least parts of the system.

172. A method of treating a human being or an animal by implanting at least part of a system according to claim 10 in a patient'"'"'s body, comprising the steps of

cutting the skin,

dissecting free an 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 can penetrate, when penetrating the housing'"'"'s outer wall, into the patient'"'"'s tissue so as to allow for stimulation of erectile tissue by injecting a substance through said at least one penetration area via the at least one infusion needle, and

closing at least the skin after implantation of at least parts of the system.

173. The method of claim 172, the at least one housing accommodating the at least one infusion needle is placed within said dissected area such that the tip end of the at least one infusion needle penetrates, when penetrating the housing'"'"'s outer wall, into at least one of the left and right corpus cavernosum and/or into at least one of the two deep arteries of the right and left corpus cavernosum and/or into at least one of the bulbs of the vestibule.

174. The method of claim 172, wherein the at least one housing accommodating the at least one infusion needle is placed within said dissected area such that the tip end of the at least one infusion needle penetrates, when penetrating the housing'"'"'s outer wall, into muscle tissue regulating blood flow through at least one of the patient'"'"'s left and right corpus cavernosum and/or regulating blood flow through the bulbs of the vestibule, and/or into another kind of tissue in close proximity to the clitoris, labia minora and/or bulbs of the vestibule.

175. The method of either of claims 173 to 174, comprising the step of securing the corpus cavernosum to the housing by means of a holder connected to the housing.

176. The method of any of claims 173 to 175, comprising the further steps of dissecting free a second area remote from the first area and placing 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.

177. The method of claim 176, wherein the reservoir is placed adjacent the patient'"'"'s symphyseal bone.

178. The method of any of claims 171 to 177, 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 a drive unit,

a reservoir,

a pump,

at least one motor for actuation of the drive unit or a drive driving the drive unit, and/or the pump or any other energy consuming part of the system,

energy storage means for providing the at least one motor with energy,

galvanic coupling elements between either an external energy source or the energy storage means and the motor for transmitting energy to the motor in contacting fashion,

wireless coupling elements adapted to connect either the motor or the energy storage means 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 for controlling the motor,

a data transmission interface for wirelessly transmitting data from an external data processing device to the control unit,

a feedback sensor,

wireless energy transforming means,

an injection port for refilling the reservoir, 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

179. A method of treating a human being or an animal by means of the system of claim 62, comprising the step of replenishing the implanted reservoir by penetrating a replenishing needle through the patient'"'"'s skin and injecting a substance through the replenishing needle directly or indirectly into the reservoir.

Method of Use

180. A method of treating a patient by means of the system of any of claims 1 to 169, with the drug delivery device being implanted in the patient'"'"'s body, comprising the step of injecting—

by means of the system—

a substance into the patient'"'"'s body in predetermined amounts, thereby stimulating sexually responsive tissue of the vulva.

181. The method of claim 180, wherein said at least one housing is implanted adjacent the patient'"'"'s left and right corpus cavernosum and/or adjacent the two deep arteries of the right and left corpus cavernosum and/or the bulbs of the vestibule and/or adjacent the patient'"'"'s muscle tissue regulating blood flow through the patient'"'"'s left and right corpus cavernosum and/or regulating blood flow through the bulbs of the vestibule.

182. The method of claim 181, 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.

183. The method of claim 180, 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.

184. The method of claim 183, comprising the step of transferring data between an external data processing device and a data transfer port of the control unit.

185. The method of claim 184, comprising the step of programming the control unit via the data transfer port.

186. The method of either of claims 184 to 185, comprising transferring feedback data from the control unit to the external data processing device.

187. The method of any of claims 184 to 187, 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.

188. The method of any of claims 184 to 187, 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.

189. The method of any of claims 186 to 188, 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.

190. The method of claim 189, 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.

191. The method of claim 189, 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.

192. The method of either of claims 180 to 191, comprising the steps of:

advancing the tip end of the at least one infusion needle through the housing'"'"'s outer wall in two different areas thereof 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 erectile tissue is desired.

193. The method of claim 192, further comprising the step of laterally moving the tip end of the at least one infusion needle within the housing for variation of an injection site within the two different areas of the housing'"'"'s outer wall.

194. The method of any of claims 180 to 193, comprising the steps of mixing a first substance from a first compartment of the 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.

195. The method of claim 194, wherein the first substance is an infusion liquid and the second substance is a drug.

196. The method of either of claims 194 to 195, wherein the second substance provided in the second compartments is in powder form.

197. The method of any of claims 194 to 196, wherein the second substance provided in the second compartments is freeze-dried.

198. The method of any of claims 194 to 197, 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.