Implantable infusion devices and methods

• US 20070233019A1
• Filed: 11/01/2006
• Published: 10/04/2007
• Est. Priority Date: 11/02/2005
• Status: Active Grant

• Current Assignee: Prosthesica AG
• Original Assignee: Potencia Medical AG
• Inventors: Forsell, Peter
• Granted Patent: US 9,504,785 B2
• Time in Patent Office: Days
• US Class Current: 604/288.30
• CPC Class Codes: A61B 17/32 Surgical cutting instruments A61B18/042 takes precedence; suture cutters A61B17/0467; instruments for ligaturing or cutting A61B17/128; instruments for rupturing the amniotic membrane A61B17/4208; specially adapted knives for eye surgery A61F9/0133
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2005/14252 with needle insertion means
• CPC Class Codes: A61M 2005/14284 with needle insertion means
• CPC Class Codes: A61M 2025/009 the needle having a bent tip, i.e. the needle distal tip is angled in relation to the longitudinal axis of the catheter
• CPC Class Codes: A61M 2205/0211 Ceramics
• CPC Class Codes: A61M 2205/073 Syringe, piston type
• CPC Class Codes: A61M 2205/075 Bulb type
• CPC Class Codes: A61M 2205/106 reciprocating
• CPC Class Codes: A61M 2205/128 with incorporated valves
• CPC Class Codes: A61M 2205/192 Avoiding coring, e.g. preventing formation of particles during puncture
• CPC Class Codes: A61M 2205/3306 Optical measuring means
• CPC Class Codes: A61M 2205/3317 Electromagnetic, inductive or dielectric measuring means
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/3337 Controlling, regulating pressure or flow by means of a valve by-passing a pump
• CPC Class Codes: A61M 2205/3389 Continuous level detection A61M2205/3393 takes precedence
• CPC Class Codes: A61M 2205/3523 using telemetric means
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: A61M 2205/8237 Charging means
• CPC Class Codes: A61M 2210/1021 : Abdominal cavity
• CPC Class Codes: A61M 2210/1042 : Alimentary tract A61M2210/0618 takes precedence
• CPC Class Codes: A61M 2210/1078 : Urinary tract
• CPC Class Codes: A61M 2210/12 : Blood circulatory system
• CPC Class Codes: A61M 2230/20 : Blood composition characteristics
• CPC Class Codes: A61M 2230/201 : Glucose concentration
• CPC Class Codes: A61M 2230/208 : pH-value
• CPC Class Codes: A61M 25/0084 : being one or more injection needles
• CPC Class Codes: A61M 5/14224 : Diaphragm type
• CPC Class Codes: A61M 5/14276 : specially adapted for implantation
• CPC Class Codes: A61M 5/1428 : with manual pumping action
• CPC Class Codes: A61M 5/158 : Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
• CPC Class Codes: A61M 5/16818 : by changing the height of the reservoir
• CPC Class Codes: A61M 5/172 : electrical or electronic A61M5/16804, A61M5/16831 take precedence
• 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 5/3291 : Shafts with additional lateral openings

Abstract

Infusion devices and methods are provided for a drug delivery system and can include an infusion needle (1) having a tip end (2) and a drive unit (D) coupled to the infusion needle and arranged for advancing the tip end of the infusion needle to penetrate any fibrosis when the infusion device is implanted in a patient'"'"'s body. The infusion needle and drive unit are designed for implantation in a patient'"'"'s body. Other components of the drug delivery system may be part of the implantable infusion device or, alternatively, be for extracorporal use cooperating with the implanted infusion device. Preferably, the infusion needle can be advanced and retracted with each infusion cycle. Furthermore, upon each advancement and/or retraction, the needle may be moved laterally so as to vary the injection site. Needle (1) and drive unit (D) are preferably disposed within a body (15), with the infusion needle being arranged for penetrating a self-sealing penetration membrane (18).

Claims

1. An infusion device, comprising:

(a) an infusion needle having a tip end; and

(b) a drive unit coupled to the infusion needle and arranged for advancing the tip end of the infusion needle to penetrate any fibrosis when the device is implanted in a patient'"'"'s body, said infusion needle and drive unit being designed for implantation in a patient'"'"'s body.

2. The infusion device of claim 1, wherein the infusion needle is disposed within a body of the device with the tip end of the infusion needle arranged for passing through an outer wall of said body.

3. The infusion device of claim 2, wherein the infusion needle is arranged for penetrating the outer wall.

4. The infusion device of claim 3, wherein the outer wall is at least partly made from a material which is self-sealing in respect of penetrations resulting from the infusion needle.

5. The infusion device of claim 4, wherein the self-sealing material forms at least one window area in the outer wall, said window area being positioned for penetration by the tip end of the infusion needle.

6. The infusion device of claim 5, wherein the window area is formed by a penetration membrane integrated in the outer wall by being sealingly press fitted into the outer wall.

7. The infusion device of claim 5, wherein the self-sealing material is made from polymer material.

8. The infusion device of claim 7, wherein the polymer material comprises at least one polymer selected from the group of materials comprising silicon and polyurethane.

9. The infusion device of claim 4, wherein the self-sealing material is made from a composite material.

10. The infusion device of claim 9, wherein the composite material comprises at least one outer shape-giving layer and a self-sealing soft material contained within the outer layer.

11. The infusion device of claim 10, wherein the self-sealing soft material is a gel.

12. The infusion device of any of claims 1 to 11, wherein the drive unit is configured for advancing and retracting the tip end of the infusion needle.

13. The infusion device of claim 1, wherein the infusion needle is disposed within a body of the device with the tip end of the infusion needle arranged for passing through an outer wall of said body and the drive unit is entirely disposed within the body of the device.

14. The infusion device of claim 1, wherein the tip end of the infusion needle is laterally movable for variation of an injection site.

19. The infusion device of claim 12, wherein the drive unit is configured to laterally displace the tip end of the infusion needle.

20. The infusion device of claim 1, wherein the infusion needle has a tube-like body closed at the tip end and having a laterally arranged delivery exit port.

21. The infusion device of claim 1, wherein a reservoir is coupled to the infusion needle.

22. The infusion device of claim 21, wherein at least a section of a periphery of the reservoir is made from a flexible material permitting volume changes of the reservoir by deformation of the flexible material as infusion liquid is filled into or drawn out of the reservoir.

23. The infusion device of claim 21, wherein the flexible material comprises a polymer membrane.

24. The infusion device of any of claims 23, wherein drawing of liquid from the reservoir causes a negative pressure in at least part of the reservoir.

25. The infusion device of any of claims 24, wherein the reservoir comprises a gas chamber and a liquid chamber, said chambers being separated by the polymer membrane.

26. The infusion device of claim 21, wherein the reservoir has an injection port for refilling the reservoir.

27. The infusion device of claim 26, wherein the injection port comprises a material which is self-sealing in respect of penetrations caused by a replenishing needle.

28. The infusion device of claim 21, wherein the infusion needle is disposed within a body of the device with the tip end of the infusion needle arranged for passing through an outer wall of said body and the reservoir is separate from the body of the device for remote implantation within a patient'"'"'s body.

29. The infusion device of claim 21, wherein the infusion needle is disposed within a body of the device with the tip end of the infusion needle arranged for passing through an outer wall of said body and the reservoir is part of or is contained within the body of the device.

30. The infusion device of claim 29, wherein at least a section of a periphery of the reservoir at least partially constitutes the outer wall of the body of the device.

31. The infusion device of claim 21, wherein a pump is coupled to the reservoir for pumping infusion liquid from the reservoir to the infusion needle.

32. The infusion device of claim 31, wherein the pump comprises a valve device having a first and a second valve member, each of said first and second valve members having a smooth surface facing each other so as to form a sealing contact between the first and second valve members and further having different liquid channels that can be brought into alignment by displacement of the two smooth surfaces relative to one another while maintaining the sealing contact.

33. The infusion device of claim 32, wherein the first and second valve members are made from a ceramic material.

34. The infusion device of claim 31, wherein the pump is a membrane type pump.

35. The infusion device of claim 34, wherein the membrane type pump comprises a membrane displaceable by a piston as the piston moves, the piston being coupled to the valve device so as to slidably displace the first and second valve members relative to one another as the piston moves.

36. The infusion device of claim 31, wherein the infusion needle is disposed within a body of the device with the tip end of the infusion needle arranged for passing through an outer wall of said body and the pump is separate from the body of the device for remote implantation within a patient'"'"'s body.

37. The infusion device of claim 31, wherein the infusion needle is disposed within a body of the device with the tip end of the infusion needle arranged for passing through an outer wall of said body and the pump is contained in the body of the device.

38. The infusion device of claim 1, wherein a reservoir is coupled to the infusion needle and a pump is coupled to the reservoir for pumping infusion liquid from the reservoir to the infusion needle, and wherein actuating means are provided for direct manual actuation of at least one of the pump and the drive unit.

39. The infusion device of claim 38, wherein the actuating means comprises a pressure sensitive switch for manual operation arranged so as to be operable when the device is implanted subcutaneously in a patient'"'"'s body.

40. The infusion device of claim 38, 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.

41. The infusion device of claim 1, wherein a reservoir is coupled to the infusion needle and a pump is coupled to the reservoir for pumping infusion liquid from the reservoir to the infusion needle, and wherein at least one motor is provided for actuation of at least one of the pump the drive unit and any other energy consuming part of the infusion device.

42. The infusion device of claim 41, wherein the motor is arranged for at least one of electrically, magnetically and electro magnetically actuating the pump, the drive unit and any other energy consuming part of the infusion device, respectively.

43. The infusion device of claim 41, wherein the motor is arranged for hydraulically actuating the pump, the drive unit and any other energy consuming part of the infusion device, respectively.

44. The infusion device of claim 41, wherein the 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.

45. The infusion device of claim 41, wherein actuating means are provided for manual activation of the motor.

46. The infusion device of claim 41, wherein the infusion needle is disposed within a body of the device with the tip end of the infusion needle arranged for passing through an outer wall of said body and the motor is contained in the body of the device.

47. The infusion device of claim 41, wherein the infusion needle is disposed within a body of the device with the tip end of the infusion needle arranged for passing through an outer wall of said body and the motor is separate from the body of the device for remote implantation within a patient'"'"'s body.

48. The infusion device of claim 46, wherein coupling elements are provided for conductive energy transfer from outside the infusion device to the at least one motor.

49. The infusion device of claim 46, wherein coupling elements are provided for wireless energy transfer from outside the infusion device to the at least one motor.

50. The infusion device of claim 49, wherein the at least one motor is arranged for being driven by an external electromagnetic field.

51. The infusion device of claim 1, further comprising an energy source providing energy to at least one of the pump, the drive unit and any other energy consuming part of the infusion device.

52. The infusion device of claim 51, wherein the infusion needle is disposed within a body of the device with the tip end of the infusion needle arranged for passing through an outer wall of said body and the energy source is part of or is contained within the body of the device.

53. The infusion device of claim 51, wherein the infusion needle is disposed within a body of the device with the tip end of the infusion needle arranged for passing through an outer wall of said body and the energy source is separate from the body of the device for remote implantation within a patient'"'"'s body.

54. The infusion device of claim 51, wherein the energy source comprises energy storage means.

55. The infusion device of claim 54, wherein the energy storage means comprises a battery.

56. The infusion device of claim 54, wherein the energy storage means comprise an accumulator.

57. The infusion device of claim 56, wherein the accumulator comprises a rechargeable battery.

58. The infusion device of claim 56, wherein the accumulator comprises a capacitor.

59. The infusion device of claim 56, wherein the infusion device comprises coupling elements for conductive energy transfer from outside the device to the accumulator for charging the accumulator from outside a patient'"'"'s body, when the device is implanted in a patient'"'"'s body.

60. The infusion device of claim 56, wherein the infusion device comprises coupling elements for wireless energy transfer from outside the device to the accumulator for charging the accumulator from outside a patient'"'"'s body, when the device is implanted in a patient'"'"'s body.

61. The infusion device of claim 51, wherein the energy source comprises coupling elements for conductive energy supply to an energy consuming part of the infusion device.

62. The infusion device of claim 51, wherein the energy source comprises coupling elements for wireless energy supply to an energy consuming part of the infusion device.

63. The infusion device of claim 1, wherein at least one control unit is provided for controlling an amount of infusion liquid to be delivered to the patient'"'"'s body through the injection needle.

64. The infusion device of claim 41, wherein a control unit is provided for controlling at least one of the pump, the drive unit, any other energy consuming part of the infusion device and, where the infusion device includes an internal or external energy source, said energy source.

65. The infusion device according claim 64, wherein the control unit is adapted to actuate the energy consuming part or energy source, respectively, at predetermined time intervals.

66. The infusion device of claim 63, wherein the device has a data transfer port for data transfer between an external data processing device and the control unit.

67. The infusion device of claim 66, wherein the data transfer port is a wireless data transfer port for the data transfer.

68. The infusion device of claim 63, wherein the control unit is programmable.

69. The infusion device of claim 63, wherein the control unit is contained in the body of the device.

70. The infusion device of claim 63, wherein the control unit is separate from the body of the device for remote implantation within a patient'"'"'s body.

71. The infusion device of claim 1, wherein at least one feedback sensor is provided for detecting parameters relevant for the treatment of a patient.

72. The infusion device according claim 71, wherein the at least one feedback sensor is adapted to sense one or more of at least one of physical parameters of the patient and process parameters of the infusion device.

73. The infusion device according claim 72, wherein the at least one feedback sensor is adapted to sense one or more parameters of a group of parameters relating to:

kind of blood cells, drug level, glucose level, oxygen level, ph level and flow volume in a blood vessel.

74. The infusion device according claim 72, 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.

75. The infusion device of claim 71, wherein the at least one feedback sensor is adapted to sense at least one of the parameters by spectrophotometry.

76. The infusion device of claim 71, wherein a reservoir is coupled to the infusion needle and a pump is coupled to the reservoir for pumping infusion liquid from the reservoir to the infusion needle and at least one control unit is provided for controlling an amount of infusion liquid to be delivered to the patient'"'"'s body through the infusion needle, wherein the at least one feedback sensor is connected to the control unit.

77. The infusion device according claim 76, further comprising at least one motor for actuation of at least one of the pump, the drive unit and any other energy consuming part of the infusion device, and a control program for controlling the at least one motor in response to one or more signals of the at least one feedback sensor.

83. The drug delivery system of claim 78, comprising as the at least one external component an external data processing device for use outside the patient'"'"'s body, said data processing device being configured for transferring data between the data processing device and the data transfer port of the control unit of the infusion device as defined in claim 66.

84. The drug delivery system of claim 83, wherein the external data processing device has a wireless data transfer port for the data transfer.

85. The drug delivery system of claim 83, wherein the external data processing device is adapted for programming the control unit.

15. The infusion device of 14, wherein the drive unit comprises a movable carriage on which the infusion needle is mounted for lateral displacement of the tip end of the infusion needle.

16. The infusion device of claim 15, wherein the movable carriage comprises a turntable.

17. The infusion device of claim 15, wherein the movable carriage comprises a shuttle.

18. The infusion device of claim 17, wherein the shuttle is in the form of a slide.

78. A drug delivery system comprising an implantable infusion device, said infusion device comprising an infusion needle having a tip end and a drive unit coupled to the infusion needle and arranged for advancing the tip end of the infusion needle to penetrate any fibrosis when the device is implanted in a patient'"'"'s body, wherein said infusion needle and drive unit are designed for implantation in a patient'"'"'s body, said drug delivery system further comprising at least one external component for cooperation with the infusion device from outside a patient'"'"'s body, when the infusion device is implanted in a patient'"'"'s body.

79. The drug delivery system of claim 78 comprising as the at least one external component an external energy source for use outside the patient'"'"'s body, said energy source being configured for transferring energy from outside the patient'"'"'s body to the infusion device.

80. The drug delivery system of claim 79, wherein galvanic coupling elements are provided for conductive energy transfer to the infusion device.

81. The drug delivery system of claim 79, wherein coupling elements are provided for wireless energy transfer to the infusion device.

82. The drug delivery system of claim 81, wherein the external energy source is 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.

86. The drug delivery system of claim 78, comprising a reservoir coupled to the infusion needle, a pump coupled to the reservoir for pumping infusion liquid from the reservoir to the infusion needle, and at least one motor for actuation of at least one of the pump, the drive unit and any other energy consuming part of the infusion device, the drug delivery system further comprising as the at least one external component an external control unit provided for controlling the at least one motor.

87. The drug delivery system of claim 86, wherein the control unit is adapted to actuate the at least one motor at predetermined time intervals.

88. The drug delivery system of claim 86, wherein the control unit is adapted for wireless remote control of the at least one motor.

89. The drug delivery system of claim 86, wherein the control unit is programmable.

90. The drug delivery system of claim 78, comprising as the at least one external component an external reservoir to be coupled to the infusion needle from outside the patient'"'"'s body.

91. The drug delivery system of claim 90, comprising as the at least one external component an external pump for being coupled to the external reservoir for pumping infusion liquid from the external reservoir to the infusion needle.

92. The drug delivery system of claim 91, comprising as the at least one external component an external motor for actuation of the external pump.

93. The drug delivery system of claim 91, comprising as the at least one external component actuating means for direct manual actuation of the external pump.

94. The drug delivery system of claim 78, comprising as the at least one external component a replenishing needle for replenishing an infusion liquid reservoir.

95. A method of treating a human being or an animal by implanting an infusion device in a patient'"'"'s body, said infusion device comprising an infusion needle having a tip end and a drive unit coupled to the infusion needle and arranged for advancing the tip end of the infusion needle to penetrate any fibrosis when the device is implanted in a patient'"'"'s body, wherein the method comprises the steps of:

(a) cutting the skin;

(b) free-dissecting a proper location for implantation of the infusion device within the patient'"'"'s body;

(c) placing the infusion device at said proper location; and

(d) closing at least the skin after placement of the infusion device.

96. The method of claim 95, wherein the step of placing the infusion device at the proper location comprises placing the infusion device or part thereof subcutaneously in the patient'"'"'s body.

97. The method of claim 95, wherein the step of placing the infusion device at the proper location comprises placing the infusion device or part thereof within fat tissue of the patient.

98. The method of claim 95, wherein the step of placing the infusion device at the proper location comprises placing the infusion device or part thereof intramuscularly within the patient'"'"'s body.

99. The method of claim 95, wherein the step of free-dissecting a proper location for implantation comprises free-dissecting a blood vessel of the patient.

100. The method of claim 99, wherein the step of placing the infusion device at the proper location comprises placing the infusion device or part thereof adjacent the blood vessel.

101. The method of claim 100, comprising the step of securing the blood vessel to the infusion device by means of a holder connected to the infusion device.

102. The method of claim 95, wherein the steps of free-dissecting a proper location for implantation and placing the infusion device at said proper location comprise opening the patient'"'"'s gastrointestinal or urinary tract and placing the infusion device in the gastrointestinal or urinary tract.

103. The method of claim 95, wherein the steps of free-dissecting a proper location for implantation and placing the infusion device at said proper location comprise free-dissecting the patient'"'"'s gastro-intestinal or urinary tract and placing the infusion device or part thereof adjacent the gastro-intestinal or urinary tract.

104. The method of claim 103, comprising the step of securing the gastro-intestinal or urinary tract to the infusion device by means of a holder connected to the infusion device.

105. The method of claim 95, wherein the step of placing the infusion device at the proper location comprises placing the infusion device or part thereof in the patient'"'"'s thorax.

106. The method of claim 95, wherein the step of placing the infusion device at the proper location comprises placing the infusion device or part thereof in the patient'"'"'s abdomen.

107. The method of claim 95, wherein the steps of cutting the skin, free-dissecting the proper location for implantation and placing the infusion device at said proper location comprise:

(a) where the infusion device is implanted in the patient'"'"'s thorax or abdomen, inserting a Varess needle or another type of gas inflation needle into the abdomen or thorax cavity and filling the abdomen or thorax cavity with a gas;

(b) cutting a key-hole;

(c) inserting at least one trocar through the key-hole towards the proper location;

(d) advancing one or more medical instruments and a camera through the at least one trocar towards said location;

(e) dissecting said location; and

(f) supplying the infusion device or part thereof to said location through the at least one trocar or through a separate incision.

108. The method of claim 95, wherein the steps of free-dissecting a proper location for implantation and placing the infusion device at said proper location comprise opening the patient'"'"'s thorax and placing the infusion device or part thereof in the patient'"'"'s thorax.

109. The method of claim 95, wherein the steps of free-dissecting a proper location for implantation and placing the infusion device at said proper location comprise opening the patient'"'"'s abdominal wall and placing the infusion device or part thereof in the patient'"'"'s abdomen.

110. The method of claim 108, wherein the step of closing at least the skin comprises suturing in layers.

111. The method of claim 95, further comprising placing within the patient'"'"'s body one or more of the following elements remote from at least the drive unit and infusion needle:

(a) a motor for actuation of the drive unit,

(b) energy storage means to provide the motor with energy, comprising at least one of a battery, a capacitor and a rechargeable battery,

(c) 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,

(d) 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,

(e) a control unit for controlling the motor,

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

(g) a feedback sensor,

(h) wireless energy receiving means,

(i) wireless energy transmission means,

(j) an infusion liquid reservoir for holding the infusion liquid, and

(k) an injection port for refilling the reservoir.

112. A method of treating a human being or an animal by means of an infusion device implanted in a patient'"'"'s body, said infusion device comprising an infusion needle having a tip end and a drive unit coupled to the infusion needle and arranged for advancing the tip end of the infusion needle to penetrate any fibrosis in the patient'"'"'s body, wherein the method comprises the step of advancing the tip end of the infusion needle when infusion liquid is to be delivered into the patient'"'"'s body.

113. The method of claim 112, wherein the step of advancing the tip end of the infusion, needle comprises advancement through any fibrosis.

114. The method of claim 112, wherein the step of advancing the tip end of the infusion needle comprises advancement into a patient'"'"'s blood vessel.

115. The method of claim 112, wherein the step of advancing the tip end of the infusion needle comprises advancement into the patient'"'"'s gastro-intestinal or urinary tract.

116. The method of claim 112, wherein the infusion needle is disposed within a body of the device with the tip end of the infusion needle arranged for passing through an outer wall of said body and wherein the step of advancing the tip end of the infusion needle comprises advancement through the outer wall of the body of the device.

117. A method of treating a human being or an animal by means of an infusion device implanted in a patient'"'"'s body, said infusion device comprising an infusion needle having a tip end and a drive unit coupled to the infusion needle and arranged for advancing the tip end of the infusion needle to penetrate any fibrosis in the patient'"'"'s body, wherein the method comprises the steps of:

(a) advancing the tip end of the infusion needle;

(b) delivering the infusion liquid through the advanced tip end of the infusion needle; and

(c) retracting the tip end of the infusion needle,

whenever infusion liquid is to be delivered into the patient'"'"'s body.

118. The method of claim 117, wherein the steps of advancing and retracting the tip end of the infusion needle comprise advancement and retraction through any fibrosis.

119. The method of claim 117, wherein the steps of advancing and retracting the tip end of the infusion needle comprises advancement into and retraction out of a patient'"'"'s blood vessel.

120. The method of claim 117, wherein the step of advancing and retracting the tip end of the infusion needle comprises advancement into and retraction out of the gastro-intestinal or urinary tract of the patient'"'"'s body.

121. The method of claim 117, wherein the infusion needle is disposed within a body of the device with the tip end of the infusion needle arranged for passing through an outer wall of said body and wherein the steps of advancing and retracting the tip end of the infusion needle comprises advancement and retraction through the outer wall of the body of the device.

122. The method of claim 117, wherein the tip end of the infusion needle is laterally movable for variation of an injection site, the method comprising the step of laterally moving the tip of the injection needle within the body of the device for variation of an injection site.

123. A method of treating a human being or an animal by means of an infusion device implanted in a patient'"'"'s body, said infusion device comprising an infusion needle having a tip end and a drive unit coupled to the infusion needle and arranged for advancing the tip end of the infusion needle to penetrate any fibrosis in the patient'"'"'s body, wherein the method comprises the step of replenishing an implanted infusion liquid reservoir of the infusion device by means of penetrating an infusion liquid replenishing needle through the patient'"'"'s skin and injecting infusion liquid through the replenishing needle into direct or indirect into the reservoir.

124. The method of claim 123, wherein the step of replenishing the reservoir comprises injecting a volume of infusion liquid through an injection port connected to or integrated in a periphery of the reservoir.

125. The method of claim 123, wherein the step of replenishing the reservoir comprises injecting into the reservoir a volume of infusion liquid of a predetermined dose.

126. A method of treating a human being or an animal by means of an infusion device implanted in a patient'"'"'s body, said infusion device comprising an infusion needle having a tip end and a drive unit coupled to the infusion needle and arranged for advancing the tip end of the infusion needle to penetrate any fibrosis in the patient'"'"'s body, wherein the method comprises the step of adapting the infusion device such that infusion liquid is delivered into the patient'"'"'s body at predetermined time intervals or in predetermined amounts or at predetermined time intervals in predetermined amounts.

127. The method of claim 126, comprising the step of controlling the infusion device from outside the patient'"'"'s body by means of an extracorporal control unit.

128. The method of claim 126, wherein a reservoir is coupled to the infusion needle, a pump is coupled to the reservoir for pumping infusion liquid from the reservoir to the infusion needle, at least one control unit is provided for controlling an amount of infusion liquid to be delivered to the patient'"'"'s body through the injection needle, said control unit being either contained in the body of the device or remotely implanted within the patient'"'"'s body separate from the body of the device, wherein the method comprises the step of controlling the infusion device from inside the patient'"'"'s body by means of the control unit of the infusion device.

129. The method of claim 128, wherein the infusion device has a data transfer port for data transfer between an external data processing device and the control unit, wherein the method comprises the step of transferring data between the external data processing device and the data transfer port of the control unit.

130. The method of claim 129, comprising the step of programming the control unit.

131. The method of claim 129, comprising transferring feedback data from the control unit to the external data processing device.

132. The method of claim 128, comprising the steps of:

(a) transferring a feedback signal from a feedback sensor to the control unit; and

(b) controlling the infusion device in relation to the feedback signal.

133. The method of claim 128, comprising the steps of:

(a) transferring a feedback signal from a feedback sensor to the control unit;

(b) transferring feedback data from the control unit to an external data processing device; and

(c) programming the control unit by means of the external data processing device to control the infusion device in relation to the feedback data.

134. The method of claim 128, comprising at least one motor for actuation of at least one of the pump, the drive unit and any other energy consuming part of the infusion device.