Modular infusion device and method

• US 20040204673A1
• Filed: 04/30/2004
• Published: 10/14/2004
• Est. Priority Date: 02/22/2001
• Status: Abandoned Application

• Current Assignee: Insulet Corporation
• Original Assignee: Insulet Corporation
• Inventors: Flaherty, J. Christopher
• Application Number:
  US10/835,770
• Publication Number:
  US 20040204673A1
• Time in Patent Office: Days
• US Class Current: 604/65
• 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 2005/1581 Right-angle needle-type devices
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2205/3546 Range
• CPC Class Codes: A61M 2205/3576 with non implanted data transmission devices, e.g. using external transmitter or receiver
• CPC Class Codes: A61M 2205/6072 Bar codes
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: A61M 2205/8237 Charging means
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 39/281 Automatic tube cut-off devices, e.g. squeezing tube on detection of air
• CPC Class Codes: A61M 5/003 Kits for diabetics
• CPC Class Codes: A61M 5/14224 Diaphragm type
• CPC Class Codes: A61M 5/14232 Roller pumps
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/1486 the bags being substantially completely surrounded by fluid
• 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 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: A61P 1/16 for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
• CPC Class Codes: A61P 21/02 Muscle relaxants, e.g. for tetanus or cramps
• CPC Class Codes: A61P 25/04 : Centrally acting analgesics, e.g. opioids
• CPC Class Codes: A61P 25/08 : Antiepileptics; Anticonvulsants
• CPC Class Codes: A61P 25/16 : Anti-Parkinson drugs
• CPC Class Codes: A61P 25/28 : for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
• CPC Class Codes: A61P 3/10 : for hyperglycaemia, e.g. antidiabetics
• CPC Class Codes: A61P 31/18 : for HIV
• CPC Class Codes: A61P 35/00 : Antineoplastic agents
• CPC Class Codes: A61P 9/10 : for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis

Abstract

A device for delivering fluid including a disposable assembly having an exit port assembly and a metering portion of a dispenser for controlling fluid flow to the exit port assembly, and a reusable assembly having a control portion of the dispenser adapted to control the metering portion of the dispenser upon attachment of the reusable assembly and the disposable assembly, a local processor connected to the dispenser and programmed to cause fluid flow to the exit port assembly through the dispenser based upon flow instructions, and a local wireless communication element connected to the local processor for receiving flow instructions from a remote wireless device. The assemblies are adapted to be removably attached, and a power source is contained in the disposable assembly for providing power to the reusable assembly upon attachment of the reusable assembly and the disposable assembly.

Claims

1. A device for delivering fluid comprising:

A) a disposable assembly including,

an exit port assembly,

a dispenser for controlling fluid flow to the exit port assembly, and

a housing containing the exit port assembly and the dispenser;

B) a reusable assembly including,

a local processor connectable to the dispenser upon attachment of the reusable assembly and the disposable assembly and programmed to cause fluid flow to the exit port assembly through the dispenser based upon flow instructions,

a local wireless communication element connected to the local processor for receiving flow instructions from a remote wireless device, and

a housing containing the local processor and the local wireless communication element and adapted to removably attach to the housing of the disposable assembly; and

C) a power source contained in the disposable assembly for providing power to the reusable assembly upon attachment of the reusable assembly and the disposable assembly.

2. A device according to claim 1, further comprising an adhesive on an outwardly facing surface of at least one of the housings for securing the device to skin of a patient.

3. A device according to claim 1, wherein the housing of the disposable assembly is flexible.

4. A device according to claim 1, wherein the housing of the reusable assembly is flexible.

5. A device according to claim 1, wherein the housing of the disposable assembly is constructed of biodegradable materials.

6. A device according to claim 1, wherein the wireless communication element communicates through radio frequency signals.

7. A device according to claim 1, wherein the housing of the reusable assembly further contains a power supply connected to the local processor.

8. A device according to claim 7, wherein the power supply of the reusable assembly is non-replacable.

9. A device according to claim 1, wherein the power supply of the disposable assembly is non-replacable.

10. A device according to claim 1, wherein the power supply of the disposable assembly is a battery.

11. The fluid device of claim 1, wherein the power supply of the disposable assembly is electrically connected to the reusable assembly through conductive contacts when the disposable assembly and reusable assembly are attached.

12. A device according to claim 11, wherein the conductive contacts are spring loaded.

13. A device according to claim 1, wherein the reusable assembly includes at least one electrical connector connected to the processor and adapted to mate with an electrical connector of the reusable assembly when the disposable assembly is attached to the reusable assembly, and wherein the electrical connector of the reusable assembly is connected to the power supply.

14. A device according to claim 1, wherein the power supply contains a predetermined amount of energy.

15. A device according to claim 1, wherein the processor includes an electrical energy storage device to power memory storage devices of the processor.

16. A device according to claim 1, wherein the housings are removably attachable with attachment projecting members extending from one of the housing of the reusable assembly and the housing of the disposable assembly, and corresponding attachment receiving holes in the other of the reusable assembly and the disposable assembly.

17. A device according to claim 16, wherein the attachment projecting members and the attachment receiving holes are provided in one of at least two shapes and at least two sizes, to cause a specific alignment when the reusable assembly is attached to the disposable assembly.

18. A device according to claim 1, further comprising alignment projecting members extending from one of the disposable and the reusable assemblies which mate with alignment receiving holes in the other of the disposable and the reusable assemblies.

19. A device according to claim 1, wherein the housings are removably attachable with screw threads.

20. A device according to claim 1, wherein the housings are removably attachable with adhesive.

21. A device according to claim 1, further comprising a reservoir within the housing of the disposable assembly, and the metering portion of the dispenser controls fluid flow from the reservoir to the exit port assembly.

22. A device according to claim 21, wherein the reservoir contains a therapeutic fluid.

23. A device according to claim 21, wherein the disposable assembly further comprising a fill port connected to the reservoir.

24. A device according to claim 21, wherein the reservoir is pressurized.

25. A device according to claim 21, wherein the reservoir contains a therapeutic fluid comprising at least one of insulin, antibiotics, nutritional fluids, TPN, analgesics, morphine, hormones or hormonal drugs, gene therapy drugs, anticoagulants, analgesics, cardiovascular medications, AZT or chemotherapeutics.

26. A device according to claim 21, wherein the reservoir contains a therapeutic fluid for treating at least one of diabetes, cardiovascular disease, pain, chronic pain, cancer, AIDS, neurological diseases, Alzheimer'"'"'s, ALS, Hepatitis, Parkinson'"'"'s Disease or Spasticity.

27. A device according to claim 21, wherein the reservoir is made of an elastic material.

28. A device according to claim 21, wherein the reservoir is pre-filled.

29. A device according to claim 21, wherein housing of the disposable assembly includes vent ports adjacent the reservoir.

30. A device according to claim 21, wherein the reservoir is pre-filled with a predetermined volume of fluid.

31. A device according to claim 21, wherein the reusable assembly applies force on the reservoir in the disposable assembly upon attachment of the reusable and the disposable assemblies.

32. A device according to claim 1, wherein the exit port assembly includes a luer connector.

33. A device according to claim 1, wherein the exit port assembly includes a cannula.

34. A device according to claim 1, wherein the disposable assembly further comprises a flow prevention assembly adapted close the exit port assembly prior to attachment of the disposable assembly and the reusable assembly.

35. A device according to claim 1, wherein the flow prevention assembly includes a pivotal member biased against the exit port assembly, and the reusable assembly includes a projecting member adapted to pivot the pivotal member away from the exit port assembly upon attachment of the disposable assembly and the reusable assembly.

36. A device according to claim 1, wherein the dispenser includes a pump mechanism.

37. A device according to claim 36, wherein the dispenser includes a drive mechanism engagable with the pump mechanism upon attachment of the disposable assembly and the reusable assembly.

38. A device according to claim 36, wherein the pump mechanism is a rotary peristaltic.

39. A device according to claim 36, wherein the pump mechanism is a linear peristaltic.

40. A device according to claim 1, wherein the dispenser includes at least one valve.

41. A device according to claim 40, wherein the dispenser includes a valve actuator engagable with the valve upon attachment of the disposable assembly and the reusable assembly.

42. A device according to claim 41, wherein the valve actuator is a piezoelectric actuators.

43. A device according to claim 41, wherein the valve actuator is a solenoid actuators.

44. A device according to claim 41, wherein the valve actuator is a thermal actuator.

45. A device according to claim 1, wherein the dispenser includes at least one pulse chamber having a predetermined volume.

46. A device according to claim 45, wherein the dispenser includes at least one diaphragm positioned against the pulse chamber

47. A device according to claim 1, wherein the disposable assembly further includes at least one sensor.

48. A device according to claim 47, wherein the sensor monitors at least one of pressure, flow, presence of fluid, presence of air, resistance, electrical current or electrical voltage.

49. A device according to claim 47, wherein the reusable assembly includes at least one sensor monitor adapted to communicate with the sensor of the disposable assembly.

50. A device according to claim 49, wherein the assemblies include mating electrical connectors adapted to connect the sensor monitor to the sensor when the disposable assembly is attached to the reusable assembly.

51. A device according to claim 1, wherein the reusable assembly further comprises at least one sensor adapted to detect a performance parameter of the disposable assembly.

52. A device according to claim 51, wherein the sensor of the reusable assembly makes physical contact with a portion of the disposable assembly when the disposable assembly is attached to the reusable assembly.

53. A device according to claim 52, wherein the sensor assembly makes physical contact with a fluid path component of the disposable assembly.

54. A device according to claim 1, wherein the housings are free of user input components for providing flow instructions to the local processor.

55. A system including a fluid delivery device according to claim 1, and further comprising a remote control device separate from the fluid delivery device and including:

a remote processor;

user interface components connected to the remote processor for allowing a user to provide flow instructions to the remote processor; and

a transmitter connected to the remote processor for transmitting the flow instructions to the wireless communication element of the fluid delivery device.

56. A system including a fluid delivery device according to claim 1, and further comprising a remote control device separate from the fluid delivery device and including:

a remote processor;

user output components connected to the remote processor for allowing a user to receive flow information; and

a receiver connected to the remote processor for receiving the flow information from the wireless communication element of the fluid delivery device.

57. A device according to claim 1, wherein the reusable assembly further comprises a sensor adapted to measure a physiologic parameter of a patient.

58. A device according to claim 57, wherein the physiologic parameter is blood glucose.

59. A device according to claim 57, wherein the sensor comprises a glucometer.

60. A device according to claim 57, wherein the sensor is remotely located from the reusable assembly and the disposable assembly and the reusable assembly includes a communication element for communicating with the sensor.

61. A device according to claim 60, wherein the remote sensor is subcutaneously implantable in a patient.

62. A device according to claim 60, wherein the remote sensor and the communication element communicate wirelessly.

63. A device according to claim 57, wherein the physiologic parameter measured by the sensor is provided to the local processor, which is further programmed to cause fluid flow to the exit port assembly through the dispenser based upon the flow instructions and the measurements provided by the physiologic parameter sensor.

64. A device according to claim 1, wherein the disposable assembly further comprises a sensor adapted to measure a physiologic parameter of a patient.

65. A device according to claim 64, wherein the physiologic parameter is blood glucose.

66. A device according to claim 64, wherein the sensor comprises a glucometer.

67. A device according to claim 64, wherein the sensor is remotely located from the disposable assembly and the reusable assembly and the disposable assembly includes a communication element for communicating with the sensor.

68. A device according to claim 67, wherein the remote sensor is subcutaneously implantable in a patient.

69. A device according to claim 67, wherein the remote sensor and the communication element communicate wirelessly.

70. A device according to claim 64, wherein the physiologic parameter measured by the sensor is provided to the local processor, which is further programmed to cause fluid flow to the exit port assembly through the dispenser based upon the flow instructions and the measurements provided by the physiologic parameter sensor.

71. A diabetes management system comprising:

a disposable assembly including a power source;

a sensor adapted to measure a physiologic parameter of a patient; and

a reusable assembly including,

a data communication assembly for receiving the physiologic parameter measured by the sensor of the disposable assembly,

a local wireless communication element for receiving flow instructions from a remote wireless device,

a local processor connected to the data communication assembly and the local wireless communication element and adapted to receive power from the power source of the disposable assembly upon attachment of the reusable assembly and the disposable assembly, and programmed to modify the flow instructions based upon the measured physiologic parameter, and

a housing containing the local processor, the local wireless communication element and the data communication assembly and adapted to removably attach to a housing of the disposable assembly.

72. A system according to claim 71, wherein the physiologic parameter is blood glucose.

73. A system according to claim 71, wherein the sensor comprises a glucometer.

74. A system according to claim 71, wherein the sensor is subcutaneously implantable in a patient.

75. A system according to claim 71, wherein the sensor is located in the disposable assembly.

76. A system according to claim 71, wherein the sensor wirelessly communicates with the data communication assembly.

77. A device according to claim 71, wherein the assemblies include mating electrical connectors adapted to connect the data communication assembly to the sensor when the disposable assembly is attached to the reusable assembly.

78. A system according to claim 71, wherein the wireless communication element communicates through radio frequency signals.

79. A system according to claim 71, wherein the power supply of the disposable assembly is electrically connected to the reusable assembly through conductive contacts when the disposable assembly and the reusable assembly are attached.

80. A system according to claim 71, wherein the housings are removably attachable with attachment projecting members extending from one of the housing of the reusable assembly and the housing of the disposable assembly, and corresponding attachment receiving holes in the other of the reusable assembly and the disposable assembly.

81. A system according to claim 71, further comprising a reservoir within the housing of the disposable assembly.

82. A system according to claim 81, wherein the reservoir contains insulin.

83. A system according to claim 71, wherein the exit port assembly includes a cannula.

84. A system according to claim 71, wherein the housings are free of user input components for providing flow instructions to the local processor.

85. A system according to claim 71, further comprising a remote control device including:

user interface components for allowing a user to input information;

a remote processor connected to the user interface components and programmed to calculate flow instructions based on the input information; and

a transmitter connected to the remote processor for transmitting the flow instructions to the wireless communication element of the reusable assembly.