Patch-sized fluid delivery systems and methods

• US 20070219480A1
• Filed: 02/09/2007
• Published: 09/20/2007
• Est. Priority Date: 02/09/2006
• Status: Active Grant

• Current Assignee: Deka Products Limited Partnership
• Original Assignee: Deka Products Limited Partnership
• Inventors: Kamen, Dean, Gray, Larry, Beavis, Russell
• Granted Patent: US 8,545,445 B2
• Time in Patent Office: Days
• US Class Current: 604/20
• CPC Class Codes: A61B 2560/0412 Low-profile patch shaped housings
• CPC Class Codes: A61B 5/0024 for multiple sensor units attached to the patient, e.g. using a body or personal area network
• CPC Class Codes: A61B 5/1427 Multiple blood sampling, e.g. at periodic or pre-established intervals
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150175 Adjustment of penetration depth
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• CPC Class Codes: A61B 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/15107 Piercing being assisted by a triggering mechanism
• CPC Class Codes: A61B 5/15117 comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
• CPC Class Codes: A61B 5/15119 comprising shape memory alloys
• CPC Class Codes: A61B 5/15121 comprising piezos
• CPC Class Codes: A61B 5/15123 comprising magnets or solenoids
• CPC Class Codes: A61B 5/15125 comprising a vacuum or compressed fluids
• CPC Class Codes: A61B 5/15186 Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
• CPC Class Codes: A61B 5/6833 Adhesive patches
• CPC Class Codes: A61J 1/20 Arrangements for transferring or mixing fluids, e.g. from vial to syringe
• CPC Class Codes: A61M 2005/1402 Priming
• 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 2005/14268 : with a reusable and a disposable component
• CPC Class Codes: A61M 2005/14506 : mechanically driven, e.g. spring or clockwork
• CPC Class Codes: A61M 2005/1581 : Right-angle needle-type devices
• CPC Class Codes: A61M 2005/1583 : Needle extractors
• CPC Class Codes: A61M 2005/1585 : Needle inserters
• CPC Class Codes: A61M 2005/1586 : Holding accessories for holding infusion needles on the body holding devices for catheters A61M25/02
• CPC Class Codes: A61M 2005/16863 : Occlusion detection
• CPC Class Codes: A61M 2005/1726 : the body parameters being measured at, or proximate to, the infusion site
• CPC Class Codes: A61M 2205/0266 : Shape memory materials
• CPC Class Codes: A61M 2205/0294 : Piezoelectric materials
• CPC Class Codes: A61M 2205/04 : implanted
• CPC Class Codes: A61M 2205/16 : with back-up system in case of failure
• CPC Class Codes: A61M 2205/18 : with alarm
• CPC Class Codes: A61M 2205/3303 : Using a biosensor
• CPC Class Codes: A61M 2205/3331 : Pressure; Flow
• 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 2205/3341 : stabilising pressure or flow to avoid excessive variation
• CPC Class Codes: A61M 2205/3368 : Temperature
• CPC Class Codes: A61M 2205/3375 : Acoustical, e.g. ultrasonic, measuring means
• CPC Class Codes: A61M 2205/3379 : Masses, volumes, levels of fluids in reservoirs, flow rates
• 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 2205/3546 : Range
• CPC Class Codes: A61M 2205/3569 : sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/3576 : with non implanted data transmission devices, e.g. using external transmitter or receiver
• CPC Class Codes: A61M 2205/3592 : using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2205/50 : with microprocessors or computers
• CPC Class Codes: A61M 2205/502 : User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/52 : with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/581 : by audible feedback
• CPC Class Codes: A61M 2205/582 : by tactile feedback
• CPC Class Codes: A61M 2205/583 : by visual feedback
• CPC Class Codes: A61M 2205/8206 : battery-operated
• CPC Class Codes: A61M 2205/8237 : Charging means
• CPC Class Codes: A61M 2206/22 : eliminating pulsatile flows, e.g. by the provision of a dampening chamber
• CPC Class Codes: A61M 2207/00 : Methods of manufacture, assembly or production
• CPC Class Codes: A61M 2209/045 : for filling, e.g. for filling reservoirs
• CPC Class Codes: A61M 2230/201 : Glucose concentration
• CPC Class Codes: A61M 5/141 : with capillaries for restricting fluid flow
• CPC Class Codes: A61M 5/1413 : Modular systems comprising interconnecting elements
• CPC Class Codes: A61M 5/142 : Pressure infusion, e.g. using pumps
• CPC Class Codes: A61M 5/14212 : Pumping with an aspiration and an expulsion action
• CPC Class Codes: A61M 5/14216 : Reciprocating piston type
• CPC Class Codes: A61M 5/14224 : Diaphragm type
• CPC Class Codes: A61M 5/14232 : Roller pumps
• CPC Class Codes: A61M 5/14244 : adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/14248 : of the skin patch type
• CPC Class Codes: A61M 5/1452 : pressurised by means of pistons
• CPC Class Codes: A61M 5/14586 : pressurised by means of a flexible diaphragm
• CPC Class Codes: A61M 5/148 : flexible, e.g. independent bagsA61M5/155 takes precedence
• CPC Class Codes: A61M 5/152 : pressurised by contraction of elastic reservoirs containers for dispensing contents by contraction of an elastic bag provided therein, in general B65D83/0061
• 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 5/162 : Needle sets, i.e. connections by puncture between reservoir and tube ; Connections between reservoir and tube in jet-action syringes A61M5/30; connectors for tubes having sealed ends and a needle for piercing them A61M39/14
• CPC Class Codes: A61M 5/168 : Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body flow control in general G05D7/00
• CPC Class Codes: A61M 5/16804 : Flow controllers
• CPC Class Codes: A61M 5/16809 : by repeated filling and emptying of an intermediate volume pressure infusion using positive displacement pumps A61M5/142
• CPC Class Codes: A61M 5/16813 : by controlling the degree of opening of the flow line
• CPC Class Codes: A61M 5/16831 : Monitoring, detecting, signalling or eliminating infusion flow anomalies low-level float-valves causing cut-off A61M5/40; indicating or recording presence, absence or direction of flow in general G01P13/0066
• CPC Class Codes: A61M 5/16886 : for measuring fluid flow rate, i.e. flowmeters
• 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 5/3287 : Accessories for bringing the needle into the body; Automatic needle insertion A61M5/20, A61M5/31525 take precedence
• CPC Class Codes: A61M 5/365 : Air detectors A61M5/1684 takes precedence; in extracorporeal blood circuits A61M1/3626
• CPC Class Codes: A61M 5/5086 : for indicating if defective, used, tampered with or unsterile
• CPC Class Codes: B23P 15/00 : Making specific metal objects by operations not covered by a single other subclass or a group in this subclass
• CPC Class Codes: F04B 43/02 : having plate-like flexible members, e.g. diaphragms F04B43/14 takes precedence
• CPC Class Codes: F04B 43/09 : Pumps having electric drive
• CPC Class Codes: F04B 43/1253 : by using two or more rollers as squeezing elements, the rollers moving on an arc of a circle during squeezing
• CPC Class Codes: F04B 7/00 : Piston machines or pumps characterised by having positively-driven valving
• CPC Class Codes: F04C 2230/60 : Assembly methods
• CPC Class Codes: G01F 22/00 : Methods or apparatus for measuring volume of fluids or fluent solid material, not otherwise provided for
• CPC Class Codes: G05B 23/02 : Electric testing or monitoring
• CPC Class Codes: G05D 7/0647 : the plurality of throttling means being arranged in series
• CPC Class Codes: G05D 7/0676 : by action on flow sources G05D7/0688, G05D7/0694 take precedence
• CPC Class Codes: G08C 17/02 : using a radio link
• CPC Class Codes: H04B 7/2609 : Arrangements for range control, e.g. by using remote antennas
• CPC Class Codes: Y10T 29/49236 : Fluid pump or compressor making
• CPC Class Codes: Y10T 29/494 : Fluidic or fluid actuated device making
• CPC Class Codes: Y10T 29/49412 : with assembly, disassembly or composite article making
• CPC Class Codes: Y10T 29/49826 : Assembling or joining
• CPC Class Codes: Y10T 29/49828 : Progressively advancing of work assembly station or assembled portion of work

Abstract

A patch-sized fluid delivery device may include a reusable portion and a disposable portion. The disposable portion may include components that come into contact with the fluid, while the reusable portion may include only components that do not come into contact with the fluid. Redundant systems, such as redundant controllers, power sources, motor actuators, and alarms, may be provided. Alternatively or additionally, certain components can be multi-functional, such a microphones and loudspeakers that may be used for both acoustic volume sensing and for other functions and a coil that may be used as both an inductive coupler for a battery recharger and an antenna for a wireless transceiver. Various types of network interfaces may be provided in order to allow for remote control and monitoring of the device.

Claims

1. Apparatus comprising:

a patch-sized housing including a reusable portion and a disposable portion that is removably engageable with the reusable portion;

wherein;

the disposable portion includes a substrate having flexible membrane material thereon and incorporating therein a fluid channel, the fluid channel being part of a fluid path in the disposable portion from a reservoir port to a cannula port and including a series of regions exposed to the flexible membrane material, at least one of such regions being a valve region; and

the reusable portion includes a control assembly having an active mechanical assembly that interacts mechanically with the regions through the membrane material in such a manner as to achieve pumping of fluid along the fluid path, the active mechanical assembly including a valve actuator operating on the valve region.

2. Apparatus according to claim 1, wherein the series of regions are exposed to a single flexible membrane of the flexible membrane material.

3. Apparatus according to claim 1, wherein the fluid path includes a fluid impedance downstream of the regions so as to prevent pumping of fluid along the path at an unsafe flow rate.

4. Apparatus according to claim 3, wherein the fluid impedance is a passive fluid impedance.

5. Apparatus according to claim 3, wherein the fluid impedance includes a tortuous conduit.

6. Apparatus according to claim 5, wherein the conduit is an integral part of the fluid channel.

7. Apparatus according to claim 5, wherein the conduit comprises coiled tubing.

8. Apparatus according to claim 7, wherein the coiled tubing includes at least two turns.

9. Apparatus according to claim 5, wherein the conduit has a serpentine shape.

10. Apparatus according to claim 5, wherein the conduit has a length greater than 2 cm.

11. Apparatus according to claim 5, wherein the conduit has a length greater than a largest dimension of the housing.

12. Apparatus according to claim 5, wherein the conduit includes an effective internal diameter selected to provide a predetermined impedance based on at least one of a viscosity and a density of the fluid.

13. Apparatus according to claim 5, wherein the conduit includes a length selected to provide a predetermined impedance based on at least one of a viscosity and a density of the fluid.

14. Apparatus according to claim 5, wherein the internal diameter of the conduit is sufficiently large to prevent occlusion due to flow of a therapeutic liquid through the conduit.

15. Apparatus according to claim 1, wherein the substrate includes a dispensing chamber formed in the fluid channel of the substrate, such chamber bounded by flexible membrane material forming a dispensing chamber membrane.

16. Apparatus according to claim 15, wherein the fluid path includes a finite fluid impedance downstream of the dispensing chamber, the fluid impedance sufficiently high so as to cause the expansion of the dispensing chamber membrane in response to the pumping of fluid induced by the active mechanical assembly.

17. Apparatus according to claim 16, wherein the control assembly includes at least a first pump mode in which the dispensing chamber is permitted to substantially empty between pump strokes and a second pump mode in which the dispensing chamber is not permitted to fully empty between pump strokes.

18. Apparatus according to claim 16, wherein the reusable portion includes a resilient dispensing spring positioned atop the dispensing chamber membrane to facilitate contraction of the dispensing chamber membrane.

19. Apparatus according to claim 18, wherein the dispensing spring includes one of a spiral shape, a fan shape, and multiple helical grooves.

20. Apparatus according to claim 16, wherein the dispensing chamber membrane includes a resilient dispensing spring to facilitate contraction of the dispensing chamber membrane.

21. Apparatus according to claim 15, wherein the control assembly includes a fluid sensor in communication with the dispensing chamber for measuring fluid flow through the dispensing chamber.

22. Apparatus according to claim 21, wherein the fluid sensor is an acoustic volume sensor.

23. Apparatus according to claim 22, wherein the acoustic volume sensor includes a loudspeaker, and wherein the loudspeaker is used by the control assembly for both acoustic volume sensing and audible alarm generation.

24. Apparatus according to claim 22, wherein the acoustic volume sensor includes a microphone, and wherein the microphone is used by the control assembly for both acoustic volume sensing and monitoring pump operation.

25. Apparatus according to claim 1, wherein the disposable portion further includes a pump region, and wherein the active mechanical assembly further includes a pump actuator operating on the pump region.

26. Apparatus according to claim 25, wherein the active mechanical assembly further includes a motor for operation of at least one of the valve actuator and the pump actuator under control of the control assembly.

27. Apparatus according to claim 26, wherein the active mechanical assembly includes a plate coupled to the valve actuator, the pump actuator, and the motor for coordinated operation of the valve actuator and the pump actuator.

28. Apparatus according to claim 27, wherein the valve region is positioned between the reservoir port and the pump region, and wherein operation of the valve actuator and the pump actuator is coordinated so as to prevent backflow of fluid toward the reservoir port.

29. Apparatus according to claim 26, wherein the motor includes a shape-memory actuator.

30. Apparatus according to claim 29, wherein the motor includes at least one pulley for folding the shape-memory actuator to fit within the reusable portion.

31. Apparatus according to claim 29, wherein the shape-memory actuator is operated through changes in heat, and wherein the motor includes a heater for operating the shape-memory actuator.

32. Apparatus according to claim 29, wherein the shape-memory actuator is operated through changes in electrical current passed through at least a portion of the shape-memory actuator.

33. Apparatus according to claim 32, wherein the shape-memory actuator is electrically coupled so as to provide a plurality of electrical paths of different lengths through the shape-memory actuator.

34. Apparatus according to claim 33, wherein a shorter electrical path is used during normal operation of a pump and a longer electrical path is used during priming and air-purging of the pump.

35. Apparatus according to claim 26, wherein the motor includes a plurality of shape-memory actuators.

36. Apparatus according to claim 35, wherein the plurality of shape-memory actuators provide for redundant operation of the active mechanical assembly.

37. Apparatus according to claim 35, wherein different numbers of shape-memory actuators are used to provide different actuation forces or stroke lengths.

38. Apparatus according to claim 35, wherein the plurality of shape-memory actuators includes shape-memory actuators of at least two different lengths.

39. Apparatus according to claim 38, wherein a shorter shape-memory actuator is used during normal operation of a pump and a longer shape-memory actuator is used during priming and air-purging of the pump.

40. Apparatus according to claim 35, wherein the plurality of shape-memory actuators includes shape-memory actuators of at least two different gauges.

41. Apparatus according to claim 1, wherein the substrate and the flexible membrane material of the disposable portion constitute a fluidic assembly, and wherein the disposable portion further includes a disposable base into which the fluidic assembly fits.

42. Apparatus according to claim 41, further comprising an adhesive pad coupled to a bottom of the disposable base.

43. Apparatus according to claim 1, wherein the reservoir port includes a reservoir interface for coupling with a fluid reservoir.

44. Apparatus according to claim 43, wherein the reservoir interface includes a cannulated needle for introduction into the fluid reservoir so as to provide fluid communication between the fluid reservoir and the fluid path.

45. Apparatus according to claim 43, wherein the reservoir interface includes a septum for penetration by a fluid reservoir cannulated needle so as to provide fluid communication between the fluid reservoir and the fluid path.

46. Apparatus according to claim 1, wherein at least one of the reusable portion and the disposable portion includes a recess for receiving a fluid reservoir.

47. Apparatus according to claim 46, wherein the fluid reservoir is eccentrically shaped, and wherein the recess is similarly shaped so as to prevent incorrect orientation of the fluid reservoir within the housing.

48. Apparatus according to claim 1, wherein the reusable portion and the disposable portion include a latching mechanism for permitting selective engagement and disengagement of the reusable and disposable portions.

49. Apparatus according to claim 48, wherein the reusable portion includes at least one latch actuator for permitting selective coupling and decoupling of the reusable and disposable portions.

50. Apparatus according to claim 1, wherein the control assembly includes an electrical power source for providing electrical power to electronics in at least one of the reusable portion and the disposable portion.

51. Apparatus according to claim 50, wherein the electrical power source is a rechargeable battery.

52. Apparatus according to claim 51, wherein the control assembly further includes a battery recharging circuit for recharging the battery.

53. Apparatus according to claim 52, wherein the control assembly further includes a coil for inductively coupling the battery recharging circuit with an external power source for recharging the rechargeable battery.

54. Apparatus according to claim 50, wherein the control assembly further includes a backup electrical power source.

55. Apparatus according to claim 54, wherein the backup electrical power source includes at least one of a battery and a supercapacitor.

56. Apparatus according to claim 1, wherein the disposable portion includes an electrical power source for providing electrical power to electronics in at least one of the reusable portion and the disposable portion.

57. Apparatus according to claim 56, wherein the electrical power source includes at least one of a battery and a supercapacitor.

58. Apparatus according to claim 1, wherein the control assembly further includes a network interface for communication with a remote controller.

59. Apparatus according to claim 58, wherein the network interface includes a wireless transceiver for wireless communication with the remote controller.

60. Apparatus according to claim 59, wherein the control assembly further includes a coil coupled to the wireless transceiver for conveying radio frequency signals to and from the wireless transceiver.

61. Apparatus according to claim 60, wherein the control assembly further includes a battery recharging circuit for recharging a rechargeable battery, wherein the coil is further coupled to the battery recharging circuit for inductively coupling the battery recharging circuit with an external power source.

62. Apparatus according to claim 58, wherein the network interface includes a communication interface for wired communication with the remote controller.

63. Apparatus according to claim 58, wherein the control assembly receives configuration information from the remote controller and sends status information to the remote controller via the network interface.

64. Apparatus according to claim 1, further comprising a speaker disposed in one of the reusable portion and the disposable portion for audible alarm generation.

65. Apparatus according to claim 1, further comprising a vibrating mechanism disposed in the reusable portion for at least one of audible and tactile alarm generation.

66. Apparatus according to claim 1, further comprising a vibrating mechanism disposed in the disposable portion for at least one of audible alarm generation, tactile alarm generation, and insertion of a needle.

67. Apparatus according to claim 1, further comprising a microphone disposed in one of the reusable portion and the disposable portion for monitoring operation of the active mechanical assembly.

68. Apparatus according to claim 1, further comprising a temperature sensor disposed in one of the reusable portion and the disposable portion for providing temperature information to the control assembly.

69. Apparatus according to claim 68, wherein the temperature sensor is one of an ambient temperature sensor and a skin temperature sensor.

70. Apparatus according to claim 1, wherein the control assembly is operably coupled to generate an alarm to indicate an operational condition.

71. Apparatus according to claim 70, wherein the alarm includes at least one of an audible alarm, a visual alarm, a tactile alarm, and a wireless alarm signal.

72. Apparatus according to claim 70, wherein the operational condition includes at least one of a power on condition, proper operation of the control assembly, and proper delivery of fluid within a predetermined set of parameters.

73. Apparatus according to claim 1, wherein the control assembly is operably coupled to generate an alarm to indicate a fault condition.

74. Apparatus according to claim 73, wherein the alarm includes at least one of an audible alarm, a visual alarm, a tactile alarm, and a wireless alarm signal.

75. Apparatus according to claim 73, wherein the fault condition includes at least one of a low power level, a low fluid level, an abnormal temperature level, a problem with a primary or backup power supply, detection of an occlusion, detection of an air bubble, detection of a fluid leak, decoupling of the reusable portion and the disposable portion, communication failure between the reusable portion and the disposable portion, expiration of the disposable portion, attempted re-use of the disposable portion, detection of abnormal vibration from the pump, and detection of lack of vibration from the pump.

76. Apparatus according to claim 1, wherein the disposable portion includes a processor for at least one of continuing device operation in the event of a failure, generating an alarm to indicate that a failure has occurred, and providing status information to the control assembly.

77. Apparatus according to claim 76, wherein the status information includes at least one of operational history of the disposable portion, characteristics of the disposable portion, and usage information.

78. Apparatus according to claim 76, wherein the control assembly is operably coupled to selectively prevent operation of the active mechanical assembly and generate an alarm based on the status information received from the processor.

79. Apparatus according to claim 1, wherein the control assembly includes a user input, operable from outside of the housing, for actuating the mechanical assembly to deliver a predetermined quantity of fluid.

80. Apparatus according to claim 79, wherein the predetermined quantity is programmable.

81. Apparatus according to claim 79, wherein the predetermined quantity is delivered as a single bolus.

82. Apparatus according to claim 79, wherein the predetermined quantity is delivered as a plurality of pulses.

83. Apparatus according to claim 79, wherein the user input includes a manual control, accessible from outside of the housing, for manual actuation of the mechanical assembly.

84. Apparatus according to claim 79, wherein the user input includes a network interface for remote actuation of the mechanical assembly from a remote controller.

85. Apparatus according to claim 79, wherein the control assembly is operably coupled to generate an alert upon attempted actuation of the mechanical assembly via the user input and to require a user confirmation before actuating the mechanical assembly to deliver the predetermined quantity of fluid.

86. Apparatus according to claim 85, wherein the alert includes at least one of an audible alert, a visual alert, a tactile alert, and a query provided from a remote controller.

87. Apparatus according to claim 79, wherein the control assembly is operably coupled to generate an alert after completing delivery of the predetermined quantity of fluid.

88. Apparatus according to claim 1, wherein the disposable portion is configured to support a cannulus in fluid communication with the fluid path and an analyte sensor in communication with the control assembly.

89. Apparatus according to claim 88, wherein interconnection between the control assembly and the analyte sensor is established upon engagement of the reusable portion and the disposable portion.

90. Apparatus according to claim 89, wherein the control assembly includes an analyte sensor interface for direct interconnection with the analyte sensor.

91. Apparatus according to claim 1, further comprising at least one pad for situation between an underside of the disposable portion and a patient'"'"'s skin so as to provide separation between the disposable portion and a patent'"'"'s skin.

92. Apparatus according to claim 91, wherein the at least one pad is secured to the underside of the disposable portion.

93. Apparatus according to claim 92, wherein the at least one pad includes adhesive for securing the disposable portion to the patient'"'"'s skin.

94. Apparatus according to claim 91, wherein the at least one pad is placed loosely between the underside of the disposable portion and the patient'"'"'s skin.

95. Apparatus according to claim 91, wherein the at least one pad is configured to provide for air flow to a portion of the patient'"'"'s skin covered by the disposable portion when placed on the patient.

96. Apparatus according to claim 95, wherein air flow is provided by at least one of passageways through the pad, passageways between pads, and construction of the at least one pad from a porous material.

97. Apparatus according to claim 1, further comprising an adhesion system for affixation of the housing to a human body, the system comprising:

a first set of three or more members, each member including an adhesive material on at least one side so as to attach to the body upon application of pressure, the members disposed around a central region; and

a second set of three or more members, each member including an adhesive material on at least one side so as to attach to the body upon application of pressure, the members disposed around the central region,

wherein the members of the first set are spaced to allow the members of the second set to attach to the body in spaces provided between the members of the first set, and wherein the members of the second set spaced to allow members of the first set to detach from the body without detaching the members of the second set.

98. Apparatus according to claim 97, wherein at least one member is perforated so as to allow facile tearing off of the member.

99. Apparatus according to claim 97, further including at least one peelable backing strip.

100. Apparatus according to claim 97, wherein the members of the first set are a first color and the members of the second set are a second color different from the first color.

101. Apparatus according to claim 1, further comprising a plurality of tethers coupled to the housing and a plurality of adhesive members for securing the tethers to a patient'"'"'s skin.

102. A disposable unit for a patch-sized fluid delivery device, the disposable unit removably engageable with a corresponding reusable unit, the disposable unit including a substrate having flexible membrane material thereon and incorporating therein a fluid channel, the fluid channel being part of a fluid path in the disposable unit from a reservoir port to a cannula port and including a series of regions exposed to the flexible membrane material, at least one of such regions being a valve region, so that an active mechanical assembly in the resusable portion can interact mechanically with the regions through the membrane material in such a manner as to achieve pumping of fluid along the fluid path, the active mechanical assembly including a valve actuator operating on the valve region.

103. A disposable unit according to claim 102, wherein the series of regions are exposed to a single flexible membrane of the flexible membrane material.

104. A disposable unit according to claim 102, further including a fluid impedance in the fluid path downstream of the regions to as to prevent pumping of fluid along the fluid path at an unsafe flow rate.

105. A disposable unit according to claim 104, wherein the fluid impedance includes at least one of a tortuous conduit that is an integral part of the fluid channel and tubing that is in fluid communication with the fluid channel.

106. A disposable unit according to claim 102, wherein the substrate includes a dispensing chamber formed in the fluid channel of the substrate, such chamber bounded by flexible membrane material forming a dispensing chamber membrane.

107. A disposable unit according to claim 106, wherein the dispensing chamber membrane includes a resilient dispensing spring to facilitate contraction of the dispensing chamber membrane.

108. A disposable unit according to claim 102, further including a pump region for operation by a corresponding pump actuator in the reusable unit through the flexible membrane material.

109. A disposable unit according to claim 102, wherein the substrate and the flexible membrane material constitute a fluidic assembly, and wherein the disposable unit further includes a disposable base into which the fluidic assembly fits.

110. A disposable unit according to claim 109, further comprising an adhesive pad coupled to a bottom of the disposable base.

111. A disposable unit according to claim 102, wherein the reservoir port includes a reservoir interface for coupling with a fluid reservoir, the reservoir port including one of a needle for introduction into the fluid reservoir and a septum for penetration by a fluid reservoir needle so as to provide fluid communication between the fluid reservoir and the fluid path.

112. A disposable unit according to claim 102, further including a latching mechanism for permitting selective engagement and disengagement with the reusable unit.

113. A disposable unit according to claim 102, further including an electrical power source for providing electrical power to electronics in at least one of the reusable unit and the disposable unit.

114. A disposable unit according to claim 102, further including at least one output selected from the group consisting of an audible output, a visual output, a tactile output, and a wireless output.

115. A disposable unit according to claim 102, configured for at least one of inserting and supporting a cannulus for fluid communication with the fluid path and an analyte sensor for communication with a control assembly of the reusable unit.

116. A disposable unit according to claim 102, further including a mechanism for attaching the disposable unit to a patient.

117. A disposable unit according to claim 116, further including a processor for at least one of continuing device operation in the event of a failure, generating an alarm to indicate that a failure has occurred, and providing status information to the reusable portion.

118. A reusable unit for a patch-sized fluid delivery device, the reusable unit removably engageable with a corresponding disposable unit including a substrate having a flexible material thereon and incorporating a fluid channel, the reusable unit including a control assembly having an active mechanical assembly that interacts mechanically with regions of the fluid channel in the substrate, including a valve region, through the flexible membrane material in such a manner as to achieve pumping of fluid along a fluid path including the fluid channel, the active mechanical assembly including a valve actuator for operating on the valve region.

119. A reusable unit according to claim 118, wherein the disposable unit includes a dispensing chamber bounded by flexible membrane material, and wherein the reusable unit includes a fluid sensor for communication with the dispensing chamber for measuring fluid flow through the dispensing chamber.

120. A reusable unit according to claim 119, further including a resilient dispensing spring positioned so as to facilitate contraction of the dispensing chamber membrane.

121. A reusable unit according to claim 119, wherein the fluid sensor is an acoustic volume sensor.

122. A reusable unit according to claim 121, wherein the acoustic volume sensor includes a loudspeaker, and wherein the loudspeaker is used by the control assembly for both acoustic volume sensing and audible alarm generation.

123. A reusable unit according to claim 121, wherein the acoustic volume sensor includes a microphone, and wherein the microphone is used by the control assembly for both acoustic volume sensing and monitoring pump operation.

124. A reusable unit according to claim 118, wherein the disposable unit includes a pump region bounded by flexible membrane material, and wherein the reusable unit includes a pump actuator for operating on the pump region through the flexible membrane material.

125. A reusable unit according to claim 124, wherein the active mechanical assembly further includes a motor for operation of at least one of the valve actuator and the pump actuator under control of the control assembly, the motor including at least one shape-memory actuator.

126. A reusable unit according to claim 118, further including a latching mechanism for permitting selective engagement and disengagement with the disposable unit.

127. A reusable unit according to claim 118, wherein the control assembly includes at least one electrical power source for providing electrical power to electronics in at least one of the reusable unit and the disposable unit.

128. A reusable unit according to claim 127, wherein the control assembly further includes a battery recharging circuit for recharging a battery and a mechanism for providing electrical power to the battery recharging circuit.

129. A reusable unit according to claim 118, wherein the control assembly further includes a network interface for communication with a remote controller.

130. A reusable unit according to claim 118, wherein the control assembly further includes at least one alarm output selected from the group consisting of an audible output, a visual output, a tactile output, and a wireless output.

131. A reusable unit according to claim 118, wherein the control assembly further includes a temperature sensor capable of sensing at least one of ambient temperature and skin temperature.

132. A reusable unit according to claim 118, wherein the control assembly includes a user input for user actuation of the mechanical assembly to deliver a predetermined quantity of fluid.

133. A reusable unit according to claim 118, wherein the control assembly is operably coupled to selectively prevent operation of the active mechanical assembly and generate an alarm based on a status of the disposable portion.

134. Apparatus comprising a patch-sized housing and an active mechanical assembly disposed within the housing, the active mechanical assembly including a mechanical pump and a motor for operation of the mechanical pump, the motor including a plurality of actuators, each capable of operating the pump independently of the other actuators so as to provide for redundancy in the event of failure an actuator.

135. Apparatus according to claim 134, wherein the redundant actuators include at least one shape-memory actuator.

136. Apparatus according to claim 135, wherein the motor includes at least one pulley for folding the shape-memory actuator to fit within the reusable portion.

137. Apparatus according to claim 135, wherein the shape-memory actuator is operated through changes in heat, and wherein the motor includes a heater for operating the shape-memory actuator.

138. Apparatus according to claim 135, wherein the shape-memory actuator is operated through changes in electrical current passed through at least a portion of the shape-memory actuator.

139. Apparatus according to claim 138, wherein the shape-memory actuator is electrically coupled so as to provide a plurality of electrical paths of different lengths through the shape-memory actuator.

140. Apparatus according to claim 139, wherein a shorter electrical path is used during normal operation of a pump and a longer electrical path is used during priming and air-purging of the pump.

141. Apparatus according to claim 135, wherein the at least one shape-memory actuator includes a plurality of shape-memory actuators.

142. Apparatus according to claim 141, wherein different numbers of shape-memory actuators are used to provide different actuation forces or stroke lengths.

143. Apparatus according to claim 141, wherein the plurality of shape-memory actuators includes shape-memory actuators of at least two different lengths.

144. Apparatus according to claim 143, wherein a shorter shape-memory actuator is used during normal operation of a pump and a longer shape-memory actuator is used during priming and air-purging of the pump.

145. Apparatus according to claim 141, wherein the plurality of shape-memory actuators includes shape-memory actuators of at least two different gauges.

146. Apparatus comprising a patch-sized housing enclosing a fluid delivery assembly and a plurality of electrical power sources for providing electrical power to the fluid delivery assembly.

147. Apparatus according to claim 146, wherein the housing includes a reusable portion and a disposable portion that is removably engageable with the reusable portion, and wherein the plurality of electrical power sources are disposed in the reusable portion.

148. Apparatus according to claim 146, wherein the housing includes a reusable portion and a disposable portion that is removably engageable with the reusable portion, and wherein the plurality of electrical power sources are disposed in the disposable portion.

149. Apparatus according to claim 146, wherein the housing includes a reusable portion and a disposable portion that is removably engageable with the reusable portion, and wherein each portion includes at least one electrical power source.

150. Apparatus according to claim 146, wherein the plurality of electrical power sources include a primary electrical power source and a backup electrical power source.

151. Apparatus according to claim 150, wherein the primary electrical power source is a rechargeable battery, and wherein the backup electrical power source is one of a battery and a supercapacitor.

152. Apparatus comprising a patch-sized housing enclosing a fluid delivery system, the fluid delivery system including a controller and a plurality of outputs in communication with the controller, the controller operably coupled generate an alarm through actuation of the plurality of outputs.

153. Apparatus according to claim 152, wherein the plurality of outputs are selected from the group consisting of an audible output, a visual output, a tactile output, and a wireless output.

154. Apparatus according to claim 152, wherein the alarm indicates at least one of an operational condition and a fault condition.

155. Apparatus according to claim 154, wherein the operational condition includes at least one of a power on condition, proper operation of the control assembly, and proper delivery of fluid within a predetermined set of parameters.

156. Apparatus according to claim 154, wherein the fault condition includes at least one of a low power level, a low fluid level, an abnormal temperature level, a problem with a primary or backup power supply, detection of an occlusion in the fluid path, detection of an air bubble in the fluid path, detection of a fluid leak, decoupling of the reusable portion and the disposable portion, communication failure between the reusable portion and the disposable portion, expiration of the disposable portion, attempted re-use of the disposable portion, detection of abnormal vibration from the pump, and detection of lack of vibration from the pump.

157. Apparatus comprising a patch-sized housing including a reusable portion and a disposable portion that is removably engageable with the reusable portion, the reusable portion including a control assembly having an active mechanical assembly for use in pumping fluid along a fluid path, the disposable portion including at least one attribute discernable by the control assembly, wherein the control assembly is operably coupled to selectively prevent operation of the active mechanical assembly and generate an alarm based on the at least one attribute.

158. Apparatus according to claim 157, wherein the attribute includes at least one of an operational history of the disposable portion, a characteristic of the disposable portion, and an attribute for usage of the disposable portion.

159. Apparatus according to claim 157, wherein the disposable portion includes a processor for providing attribute information to the control assembly.

160. Apparatus comprising a patch-sized housing including a reusable portion and a disposable portion that is removably engageable with the reusable portion, the reusable portion including a main controller, the disposable portion including a backup controller capable of at least one of continuing an operation normally provided by the main controller and generating an alarm to indicate a failure of the main controller.

161. Apparatus comprising a patch-sized housing enclosing a fluid delivery system, the fluid delivery system including a controller and a user interface in communication with the controller, wherein the controller is operably coupled to control delivery of fluid to a patient and to test and report responsiveness of the patient via the user interface.

162. A wearable device for parenteral delivery of fluid, the device having at least a reservoir, a pump having a motor, and an exit assembly, and separable reusable and disposable portions, wherein the motor resides in the disposable portion.

163. A device according to claim 162 wherein all wetted parts reside in the disposable portion.

164. A device according to claim 162 wherein the motor uses a shape-memory material to convert a source of potential energy into kinetic energy.

165. A system for pumping fluid to a subject, the system comprising:

a first separable component including

an inlet fluid path in communication with a fluid source;

a pumping chamber for receiving fluid from the inlet fluid path;

a dispensing chamber for receiving fluid from the pumping chamber;

an outlet fluid path for carrying fluid from the dispensing chamber to an exit assembly; and

a second separable component including

a force application assembly for compressing the pumping chamber, and

means for sensing flow conditions through the line.

166. A system according to claim 165, wherein the force application assembly causes flow of fluid to the pumping chamber from the inlet fluid path to be restricted while urging fluid from the pumping chamber to the dispensing chamber.

167. A system according to claim 165, wherein the first separable component further includes a reservoir as a fluid source.

168. A base sled for holding separable components of a device for delivery of a therapeutic fluid, the device comprising:

a bottom adapted for adhesion to the skin of a patient;

a fluidic path portion having a pumping chamber and an outlet; and

a groove for securely receiving one or more of a fluid cannula and a probe cannula,

wherein the sled is adapted to receive a disposable insulin cartridge and a reusable portion.

169. A sled according to claim 168 further including three or more adhesive members for adhesive attachment to the skin of the patient, the members disposed around a central region;

and an attachment means for joining the adhesive members to the device.

170. A sled according to claim 168, wherein the reusable portion include a component selected from the group consisting of:

a flow sensor, an assembly for application of force to the pumping chamber, a power source, transceiver electronics, a microprocessor, and an alarm.

171. A sled according to claim 168, further including a mating feature for the attachment of a fluid reservoir.

172. A sled according to claim 171, wherein the mating feature is a septum.

173. A sled according to claim 171, wherein the mating feature is a needle

174. A sled according to claim 168, further including leads for the establishment of signal communication between a probe attached to the probe cannula and the reusable portion.

175. An irregularly shaped fluid reservoir adapted for holding a supply of a therapeutic fluid within a patch-sized housing having a correspondingly shaped reservoir holding chamber, the fluid reservoir having a cavity defined by a rigid reservoir body and a flexible reservoir membrane that is sealingly attached to the rigid reservoir body around the periphery of the cavity, the flexible reservoir membrane including at least one portion that collapses as therapeutic fluid is withdrawn, the irregular shapes of the fluid reservoir and the corresponding reservoir holding chamber providing for proper orientation of the fluid reservoir within the reservoir holding chamber.

176. A reservoir according to claim 175, further including a port through which the reservoir can be placed in fluid communication with a corresponding fluid path in the housing.

177. A reservoir according to claim 176, wherein the port includes one of a septum for penetration by a fluid path needle and a needle for introduction into the fluid path for providing fluid communication between the reservoir and the fluid path.

178. A reservoir according to claim 176, wherein the port is seated in a neck extending from a reservoir body.