IMPLANTABLE INFUSION DEVICES AND METHODS

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.

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.

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 claim 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 claim 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.

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.

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.

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 gastro-intestinal or urinary tract and placing the infusion device in the gastro-intestinal 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.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0052] FIG. 1 shows a strictly mechanical infusion device according to a first embodiment of the subject matter.

[0053] FIG. 2 shows the infusion device of FIG. 1 diagrammatically with some modifications.

[0054] FIG. 3 shows a cross sectional view of a strictly mechanical, completely implantable infusion device according to a second embodiment of the subject matter.

[0055] FIG. 4 shows a plan view of a part of the infusion device of FIG. 3, located adjacent a blood vessel.

[0056] FIG. 5 shows a cross sectional view of a penetration membrane made from a composite material.

[0057] FIG. 6 shows a motor-driven infusion device according to a third embodiment of the subject matter.

[0058] FIG. 7 shows a motor-driven pump unit suitable for use in connection with the embodiment shown in FIG. 6.

[0059] FIG. 8 shows a fully automatic unitary infusion device implanted subcutaneously adjacent a blood vessel.

DETAILED DESCRIPTION OF DRAWINGS

[0060] FIG. 1 shows a strictly mechanical, more exactly a hydro-mechanical, infusion device implanted subcutaneously under a patient's skin 100. The infusion device comprises a needle 1 having a tip end 2. Tip end 2 is closed at its distal end and has a lateral drug delivery exit port 3. Needle 1 is arranged for longitudinal displacement within an open-ended tube 4 upon activation by a drive unit D.

[0061] Tube 4 penetrates the skin 100 and is attached to an extracorporal pump P. Pump P is schematically shown and can be designed in many ways. In the embodiment shown in FIG. 1, reservoir R with infusion liquid to be delivered to the patient is part of pump P. Alternatively, reservoir R could be separate from pump P and connected thereto, e.g. as principally shown in FIG. 2. In the embodiment of FIG. 1, however, a piston 10 of pump P is manually displaceable by means of an actuator 11 in the form of a piston rod so as to pump the infusion liquid from reservoir R through tube 4 towards needle 1. Instead of being manually driven, the pump could be motor-driven, and the motor could be automatically controlled so as to deliver a certain amount of drugs at certain time intervals. Reservoir R, pump P and/or other components of the drug delivery system, such as the aforementioned motor, automatic control for the motor, etc., may alternatively be implanted along with infusion needle 1 and drive unit D. Other modifications are possible and will become apparent upon further consideration of the embodiments described later in reference to FIGS. 2 to 8.

[0062] In the infusion device shown in FIG. 1, as the pressure is increased in reservoir R by actuation of piston 10, this will result in a displacement of needle 1 against the force of a spring 5 of drive unit D. Thus, tip end 2 of needle 1 will penetrate any fibrosis having built up in front of the infusion device. When return spring 5 is completely compressed and the pressure exerted on the infusion liquid by means of piston 10 is further increased, a ball valve 6 will be displaced against a second return spring 7 which is stronger than the first return spring 5. That way, as long as the pressure is held at a sufficiently high level, infusion liquid will be pumped from reservoir R through tube 4, hollow needle 1 and the needle's exit port 3 into the patient's body. Upon pressure release, ball valve 6 will close due to return springs 5 and 7, and then needle 1 will be retracted to its initial position shown in FIG. 1.

[0063] The fit between the outer surface of needle 1 and the inner surface of tube 4 should be sufficiently tight to prevent any fibrosis from growing in.

[0064] It should be noted that the force acting on needle 1 to advance the same may be calculated as the product of the actual pressure and the cross section of needle 1. Since the cross section of a typical infusion needle is relatively small, high pressure will have to be exerted in order to penetrate any fibrosis and to overcome the counteracting forces of return springs 5 and 7. It is therefore advantageous to construct drive unit D such that two strictly separated chambers are formed in front of and behind the drive unit. Thus, when the chamber behind drive unit D is kept at low pressure, such as ambient pressure, the force acting on needle 1 would correspond to the product of the actual pressure and the entire cross section of drive unit D and, thus, be substantially higher.

[0065] This is shown in FIG. 2. Drive unit D comprises a piston 8 to which needle 1 is attached as shown in FIG. 1. Piston 8 separates a first chamber 9a in front of piston 8 and a second chamber 9b behind piston 8. While the pressure in first chamber 9a corresponds to the pressure exerted by pump P, the pressure in second chamber 9b can be kept at a lower value.

[0066] For instance, chamber 9b could be filled with a compressible gas. In that case, return spring 5 could be dispensed with as the compressed air would already create a needle retraction force.

[0067] It is, however, difficult to securely seal a gas chamber. Therefore, second chamber 9b is instead filled with liquid, such as the infusion liquid, and the liquid may be urged into a flexible volume 12. The flexible volume 12 could be of simple balloon type so as to fill up without exerting any strong counter force. Alternatively, the flexible volume 12 may comprise a gas chamber separated from the liquid of second chamber 9b by a flexible membrane. Again, return spring 5 could be dispensed with in this case.

[0068] Instead of the flexible volume 12, a conduit 13 may connect second chamber 9b with reservoir R. Thus, when needle 1 is advanced, liquid will be dispelled from second chamber 9b through conduit 13 into reservoir R, and as needle 1 is retracted by means of return spring 5, liquid will be drawn from reservoir R through conduit 13 back into second chamber 9b.

[0069] Clearly, pump P and reservoir R may be implanted into the patient's body along with drive unit D and needle 1, either remote thereof or as a single unit, if desired.

[0070] FIG. 3 shows a completely implantable, strictly mechanical infusion device to be implanted subcutaneously. The individual components of the device are contained within a unitary body 15 comprising an outer wall 16a, 16b. The volume defined by outer wall 16a, 16b is completely filled with infusion liquid. A wall portion 16a is flexible so as to allow for volume changes occurring with each injection and refill. Wall portion 16a is made from a polymer material which is self-sealing with respect to the penetration of a replenishing needle. The infusion device can thus be refilled with infusion liquid through the polymer wall portion 16a while being implanted subcutaneously.

[0071] The other wall portion 16b is rigid to provide some stability for the individual components contained within body 15. A window area 17 is formed in rigid wall portion 16b and a penetration membrane 18 is sealingly press fitted in Window area 17. Penetration membrane 18 is made from a self-sealing material in respect of penetrations resulting from infusion needle 1, which infusion needle is arranged for penetrating window area 17.

[0072] Needle 1 is connected to a piston 8 separating a first chamber 9a in front of piston 8 and a second chamber 9b behind piston 8, as discussed above in reference to FIG. 2. A return spring 5 and a ball valve 6 with a return spring 7 are also provided. Openings 19 are provided to connect second chamber 9b to reservoir R so that when the pressure is raised in first chamber 9a piston 8 may dispel infusion liquid from second chamber 9b through openings 19 into reservoir R, which reservoir R is approximately at ambient pressure.

[0073] The pressure in first chamber 9a is increased by means of a pump P comprising a piston 10 formed as a unitary piece with an actuator 11 in the form of a manually actuated push button. A return spring 20 serves to urge piston 10 into its initial position shown in FIG. 3. A flow passage 21 is formed in the piston 10 with a flow constriction 22 and an exit opening 23 arranged a short distance above a housing 24 in which piston 10 is slidably arranged.

[0074] The infusion device shown in FIG. 3 functions as follows. When arranged subcutaneously with the push button 11 facing the skin, the patient may press down the push button 11 against the spring force of return spring 20. Due to flow constriction 22 in flow passage 21, the infusion liquid contained in first chamber 9a will not flow back into reservoir R through flow passage 21 but will urge piston 8 with needle 1 towards window area 17 while expelling infusion liquid from second chamber 9b through openings 19 into reservoir R. When piston 8 is in its end position and push button 11 is pressed down further, the pressure in first chamber 9a will eventually rise to a level sufficiently high to overcome the spring force of return spring 7, thereby opening ball valve 6 and allowing infusion liquid to be discharged through hollow needle 1, the tip end 2 of which has meanwhile penetrated penetration membrane 18 and any fibrosis built up thereon. Upon pressure release, ball valve 6 will immediately close and return spring 20 will urge push button 11 back into its initial position while simultaneously drawing back piston 8 with infusion needle 1 into its retracted position. Return spring 5 could be dispensed with and merely serves as a safety means. The flow passage 21 is needed to allow push button 11 to move further up even after piston 8 has reached its starting position, thereby drawing additional infusion liquid from reservoir R into first chamber 9a, which additional infusion liquid compensates the amount of infusion liquid delivered to the patient during the injection cycle.

[0075] The infusion device shown in FIG. 3 provides several advantages such as being strictly mechanical, not involving any gas chambers and not requiring any particular sealing of the piston elements 8 and 10.

[0076] In addition to the advancing and retracting capabilities of drive unit D, the drive unit of the infusion device shown in FIG. 3 further comprises means for laterally displacing the tip end of the infusion needle 1. In the particular embodiment of FIG. 3, a specific example of such lateral displacing means is shown. More particularly, needle 1 is mounted on a turntable 25 which is rotatably mounted in a circular groove 26 of second wall portion 16b. Furthermore, a guide pin 27 is securely mounted on the needle 1 to cooperate with a guide structure 28 securely fixed to rigid wall portion 16b of outer wall 15. Upon advancement or retraction of infusion needle 1, guide pin 27 will be guided in guide structure 28 and thereby laterally displace infusion needle 1, which lateral displacement causes rotation of turntable 25 within circular groove 26.

[0077] The principle of guide structure 28 will now be described in more detail in relation to FIG. 4. Resilient flaps 28a, 28b within guide structure 28 serve to guide pin 27 through the entire guide structure 28 upon repeated advancement and retraction of infusion needle 1. Guide structure 28 is designed to provide ten different injection sites through penetration membrane 18 into a blood vessel 200 located adjacent penetration membrane 18. Where it is desired, the trajectory of guide structure 28 may include a return path 28c for guide pin 27 to return to its starting position shown in FIG. 4. Such return action will be caused by a return spring 29 fixed to the rigid second wall portion 16b.

[0078] It should be noted that all components of the infusion device shown in FIG. 3 may be made from polymer material although it is preferable that at least infusion needle 1 and return springs 5, 7, 20, 29 be made from an inert metal.

[0079] FIG. 5 shows one aspect of penetration membrane 17 in the form of a composite material. The same material can also be used for the flexible first wall portion 16a of outer body 15 or for an infusion port that will be described below in connection with another embodiment of the subject matter. The composite material of penetration membrane 17 shown in FIG. 5 comprises an outer shape-giving layer 17a defining a volume in which a self-sealing soft material 17b is contained. Self-sealing soft material 17b can be of gel type having a viscosity such that it does not flow through any penetrations caused by infusion needle 1 during penetration of outer shape-giving layer 17a. Instead of a single outer shape-giving layer 17a, shape-giving layer 17a may comprise a plurality of layers. Outer shape-giving layer 17a preferably comprises silicon and/or polyurethane, since such materials can be produced to have self-sealing properties in respect of penetrations resulting from infusion needle 1.

[0080] FIG. 6 shows a fully automatic embodiment of the infusion device according to the present subject matter. It is to be understood, however, that manually operated elements as discussed above and automatically operating elements as discussed herein below may be combined and interchanged where this is possible. The overall drug delivery system in FIG. 6 is shown schematically, wherein all components disposed underneath the patient's skin 100 are part of the implantable infusion device whereas the components above the patient's skin 100 are needed to complete the drug delivery system.

[0081] A pump P driven by a motor M connects a reservoir R with an infusion needle 1 mounted on a drive unit D within a body 15 so as to penetrate upon advancement a penetration membrane 17 of body 15. A fluid conduit 4 is long enough to compensate for the advancement of infusion needle 1. While drive unit D may be activated hydraulically by forces generated by pump P, similar to the embodiments discussed above, a separate motor may be provided to actuate drive unit D. Alternatively, motor M may be designed to actuate drive unit D and any movement of drive unit D may cause pump P to pump.

[0082] Although the embodiment shown in FIG. 6 may comprise one of a great variety of reservoir types, a particular reservoir type will now be described. The volume of reservoir R shown in FIG. 6 is divided into two sections by means of a membrane 60. One section is filled with gas whereas the other section is filled with infusion liquid. An infusion port 61 allows for refilling reservoir R with infusion liquid by means of a replenishing needle. When reservoir R is in its full state, the gas section is at ambient pressure or over-pressurized. As infusion liquid is drawn from reservoir R 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 62 to prevent any back flow from pump P to reservoir R.

[0083] Motor M is wirelessly controlled by a control unit C from outside the patient's body. Control unit C determines the time period between infusion cycles as well as the amount of infusion liquid to be injected into the patient's body upon each infusion cycle. Instead of wireless communication between control unit C and motor M, galvanic contacts may be provided through the skin 100. Also, the control unit C may be implanted along with motor M. In that case, control unit C is preferably programmable from outside the patient's body, either wirelessly or through galvanic contacts, so as to allow proper configuration of the control unit according to changing demands.

[0084] In addition to or instead of control unit C, a pressure sensitive switch for activating motor M may be arranged subcutaneously.

[0085] There are various ways of providing motor M with energy. For instance, energy may be supplied from outside the patient's body either for direct use by motor M and/or for charging an accumulator A, such as a rechargeable battery and/or a capacitor. In the embodiment shown in FIG. 6, 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 accumulator A which provides secondary energy to motor M upon demand.

[0086] In general, external 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, energy transforming device T as shown in FIG. 6 may act as a solar cell, but adapted to the particular type of wave signal of primary energy source E. Energy transforming device T may also be adapted to transform temperature changes into electrical energy.

[0087] Instead of an external primary energy source E, an implantable primary energy source E may be used, such as a regular long-life battery instead of accumulator A.

[0088] The energy signal can also be used to transmit control signal of the control unit C 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.

[0089] FIG. 7 shows a cross sectional view of a motor-pump unit that could be used in connection with the arrangement shown in FIG. 6. This motor-pump unit is extensively described in WO 2004/012806 A1 and the other pump units disclosed therein may be employed in connection with the present subject matter as well. The motor-pump unit comprises a valve pump assembly, wherein a membrane pump P and a valve pump device 30 constitute two main elements of the assembly mounted in a cylindrical housing 31. Valve device 30 includes a first valve member in the form of a ceramic disc 32 stationary mounted on and fixed to housing 31, and a second valve member in the form of a ceramic disc 33 facing and touching ceramic disc 32 and rotatable relative to stationary disc 32. A motor 34 is mounted on housing 31 enclosing ceramic discs 32 and 33. Motor 34 includes a splined motor shaft coupled to corresponding splines in an under central hole in rotatable disc 33 to allow disc 33 to move somewhat in an axial direction relative to motor shaft 35, although disc 33 follows the rotation of motor 31. On motor shaft 35 is mounted a stop member 36 and a spring washer 37 that exerts a slight amount of pressure against disc 33 to urge it against stationary disc 32.

[0090] Pump P includes a pump membrane 47 that can be any kind of membrane. Preferably, membrane 47 is a metal membrane, for example a titanium membrane, or a type of coated plastic material for achieving long lifetime and avoiding diffusion of liquid through membrane 47 over time. An operation device, which in this embodiment is incorporated in the valve pump assembly, includes a cam sleeve 48 which has a cut-out groove with two opposite cam surfaces 49, a cam wheel 50, which rotates in the cut-out groove pushing against cam surfaces 49, and a pump shaft 51 connected to rotary disc 33. Cam wheel 50 is mounted via a cam wheel shaft 52 onto pump shaft 51. Pump shaft 51 rotates because it is connected to rotating disc 33 via a splined shaft 57 that is coupled to corresponding splines in an upper central hole 53 in rotatable disc 33. The described spline coupling allows disc 33 to move somewhat in an axial direction relative to pump shaft 51. Pump shaft 51 is mounted in an encapsulated ball-bearing 54 and is stationary in an axial direction with respect to ball-bearing 54. Several elongated grooves 55 on pump shaft 51 extend past ball-bearing 54 and serve as liquid flow passages between first channel 38 of stationary disc 32 and a pump chamber 56 under membrane 47.

[0091] When motor 34 is rotating, membrane 47 moves up and down. As membrane 47 moves up and down, rotatable disc 33 connects first channel 38 alternately to second and third channels 40 and 41 so that liquid is either transmitted from second channel 40 or third channel 41 to pump chamber 56 or received from pump chamber 52 by second channel 40 or third channel 41, respectively. In FIG. 7, first channel 38 is shown as being connected to second channel via opened channel 46 so that second channel 40 receives liquid through first channel 38 from chamber 56.

[0092] The particular material selected for discs 32 and 33 is important because the selected material must be able to function using very fine tolerances without such discs sticking to one another over time. There are several materials available on the market that are suitable for this purpose, e. g. ceramic or ceramic mixed with other materials, such as carbon fiber.

[0093] FIG. 8 shows a third embodiment of the present subject matter with the infusion device being automatically driven and all components of the infusion device being contained within an outer body 15. The device is substantially disc-shaped with a lateral extension with a holder 90 for blood vessel 200 to maintain blood vessel 200 proximate the body 15. The infusion device shown in FIG. 8 is seen through a window in the patient's skin 100 while being implanted subcutaneously. Skin 100 covers the flat surface of the disc-shaped device.

[0094] Infusion needle 1 is mounted on a turntable which is part of drive unit D. Upon rotation of the turntable, the tip end of infusion needle 1 will move laterally along window 18 which is positioned proximate blood vessel 200. More particularly, infusion needle 1 is mounted on the turntable so as to be axially movable thereon back and forth such that its tip end will pass through window 18 at an inclined angle. Due to the inclination angle, the tip end of infusion needle 1 will not penetrate the opposite boundary of blood vessel 200 when it is advanced through window 18 into blood vessel 200. Holder 90 supports blood vessel 200 during penetration and injection by the needle.

[0095] Again, the interior of body 15 may serve as reservoir R. Alternatively, reservoir R may be provided as a confined chamber either within body 15 or, preferably, with a section of its periphery constituting a part of the outer wall of the body 15. If such peripheral section is made from a flexible material, such flexibility could compensate for any volume changes in reservoir R. However, at least an injection port 61 should be provided to allow for refilling reservoir R.

[0096] A pump P connects reservoir R with an infusion needle 1 which is mounted on a drive unit D for both longitudinal and lateral displacement.

[0097] Pump P is driven by a first motor M and drive unit D is driven by a separate, second motor M. Alternatively, a single motor M may be used to drive both pump P and drive unit D. Also, as described above, actuation of pump P may simultaneously cause actuation of drive unit D. Alternatively, actuation of drive unit D may cause actuation of pump P.

[0098] A long-life battery B is provided to supply the two motors M with energy. Alternatively, an accumulator, such as a rechargeable battery, may be used instead of long-life battery B.

[0099] Furthermore, a control unit C is provided to control the two motors M. In the embodiment shown in FIG. 8, control unit C is programmable from outside the patient's body by means of an external data processing device 80. Data exchange between the data processing device 80 and control unit C is preferably wireless through an implanted data transmission interface for wirelessly transmitting data from outside the patient's body to the control unit C, but can be by wire through the patient's skin, if desired. Furthermore, data exchange is preferably bidirectional so as to also allow data transmission from control unit C to data processing device 80. Such data may include data on the performance of the device, number of infusion cycles performed, filling status of reservoir R and the like.

[0100] The infusion device in FIG. 8 further includes a feedback sensor F whichin the embodiment shown in FIG. 8is placed in a blood vessel 200 to detect physiological parameters. Such parameters are fed to control unit C and might be used by a corresponding control program to prompt an infusion cycle. Alternatively or in addition, the physiological parameters may be transferred to external data processing device 80 and help the doctor in making a proper diagnosis. Eventually, the doctor will then use the data processing device 80 to adapt control unit C in accordance with the physiological parameters provided by feedback sensor F. Any kind of physical parameters of the patient or process parameters of the infusion device may be sent back to the control unit and the control unit may control the infusion device according to the results.

[0101] While FIG. 8 shows the third embodiment of the present subject matter with the infusion device being automatically driven and all components of the infusion device being contained within outer body 15, it should be understood that one or more of the various components may be implanted separate from outer body 15, such as battery B, or even outside the patient's body, such as control device C. Also, pump P and/or reservoir R may be connected separately to outer body 15, preferably attached thereto in close proximity. Components not specifically shown in FIG. 8 might be those as described in respect of the foregoing embodiments or might be different.

[0102] A method of treating a human being or an animal by implanting any one of the above described infusion devices in a patient's body comprises the steps of: [0103] (a) cutting the skin; [0104] (b) free-dissecting a proper location for implantation of the infusion device within the patient's body; [0105] (c) placing the infusion device at said proper location; and [0106] (d) closing at least the skin after placement of the infusion device.

[0107] Closing the skin may for instance include suturing, taping and other suitable techniques. The infusion device may be placed subcutaneously in the patient's body or within fat tissue or intramuscularly. In case it is placed adjacent a blood vessel (200) for injecting the infusion liquid directly into the circulating blood, the step of free-dissecting a proper location for implantation comprises free-dissecting the respective blood vessel and placing the infusion device adjacent the blood vessel. The blood vessel may then be secured to the infusion device by means of the holder 90 connected to the infusion device.

[0108] Alternatively, the infusion device may be placed within or adjacent the patient's gastro-intestinal or urinary tract. In the case of placing it adjacent the tract, again, it may be secured to the gastro-intestinal or urinary tract by means of a holder connected to the infusion device. As a further alternative, the infusion device may be placed in the patient's thorax or in the patient's abdomen.

[0109] Where the infusion device is placed adjacent a blood vessel or adjacent or within the patient's gastro-intestinal or urinary tract or within the patient's thorax or abdomen, the steps of cutting the skin, free-dissecting the proper location for implantation and placing the infusion device at said proper location may comprise: [0110] (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; [0111] (b) cutting a key-hole; [0112] (c) inserting at least one trocar through the key-hole towards the proper location; [0113] (d) advancing one or more medical instruments and a camera through the at least one trocar towards said location; [0114] (e) dissecting said location; and [0115] (f) supplying the infusion device or part thereof to said location through the at least one trocar or through a separate incision in the skin.

[0116] For instance, the reservoir R may be placed in the abdomen or thorax cavity in the way described above. Alternatively, the infusion device or part thereof, such as the reservoir R, may be implanted by open surgery, in which case the thorax or abdominal wall is opened for placing the infusion device at the proper location within the patient's thorax or abdomen and, afterwards, the skin and other layers of tissue are closed, such as by suturing, and are preferably sutured in layers.

[0117] Replenishing of the reservoir R preferably comprises the step of injecting a volume of infusion liquid through an injection port connected to and/or integrated in the periphery of the reservoir.

[0118] One or more of the following elements of the infusion device may be implanted remote from at least drive unit D and infusion needle 1: [0119] (a) motor M for actuation of drive unit D; [0120] (b) energy storage means B to provide motor M with energy, comprising at least one of a battery, a capacitor and a rechargeable battery; [0121] (c) galvanic coupling elements 90 between either external energy source E or energy storage means B and motor M for transmitting energy to motor M in contacting fashion; [0122] (d) wireless coupling elements adapted to connect either motor M or energy storage means B or both to extracorporal primary energy source E for transmitting energy to either motor M or energy storage means B or both in non-contacting fashion; [0123] (e) control unit C for controlling motor M; [0124] (f) wireless energy transmission or receiving means; [0125] (g) the data transmission interface for wirelessly transmitting data from external data processing device 80 to control unit C; [0126] (h) feedback sensor F; [0127] (i) reservoir R for holding the infusion liquid; and [0128] (j) injection port 61 for refilling the reservoir. It will be understood that various details of the presently disclosed subject matter may be changed without departing from the scope of the presently disclosed subject matter. Furthermore, the foregoing description is for the purpose of illustration only, and not for the purpose of limitation.