PORTABLE INFUSION DEVICE WITH MEANS FOR MONITORING AND CONTROLLING FLUID DELIVERY

• US 20100145276A1
• Filed: 07/31/2008
• Published: 06/10/2010
• Est. Priority Date: 08/01/2007
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Gescheit, Iddo M., Yodfat, Ofer
• Granted Patent: US 8,641,670 B2
• Time in Patent Office: Days
• US Class Current: 604/151
• 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 2209/01 Remote controllers for specific apparatus
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 5/1413 Modular systems comprising interconnecting elements
• CPC Class Codes: A61M 5/14232 Roller pumps
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/1456 with a replaceable reservoir comprising a piston rod to be moved into the reservoir, e.g. the piston rod is part of the removable reservoir
• CPC Class Codes: A61M 5/14566 with a replaceable reservoir for receiving a piston rod of the pump

Abstract

A device (1000) for delivering a therapeutic fluid (e.g. insulin) into a body of a patient are provided. In one aspect, the device can be implemented with a help of a patch unit (10) securable to a cradle unit (20) or to the body of the patient. The patch unit can employ a driving mechanism (120), a power source (210), a processor (110), a user interface (14) and a display(12). The processor can be adapted for controlling the driving mechanism by using one or more inputs. The inputs can corresponding to a basal rate and/or a bolus profile. The display can be adapted for displaying the inputs. The user interface can be adapted for adjusting the inputs.

Claims

1-36. -36. (canceled)

37. A portable therapeutic fluid delivery device for delivering a therapeutic fluid into a body of a patient comprising:

a patch unit configured for securing to a cradle unit or to the skin of the patient, the patch unit comprising a reservoir, a pump, a power source, a processor, a user interface and a display, wherein;

the processor is configured for controlling the pump to deliver the therapeutic fluid from the reservoir to the body of the patient according to one or more inputs,

the one or more inputs corresponding to at least one of a basal rate and a bolus profile,

the user interface is configured for adjusting the one or more inputs; and

the display is configured for displaying at least one of an indication of therapeutic fluid flow, a pump operation and the one or more inputs.

38. The device of claim 37, further comprising a cover for substantially covering the display.

39. The device of claim 37, wherein the display comprises a touch sensitive screen.

40. The device of claim 37, wherein the display is operable when the patch unit is disconnected from either the cradle unit or the skin of the patient.

41. The device of claim 37, wherein the display is further configured for displaying one or more of:

a bodily analyte level, nutrition values of foods, an amount of carbohydrates, an amount of therapeutic fluid held in the reservoir and at least one of amounts and percentages of delivered therapeutic fluid.

42. The device of claim 37, wherein the display comprises a liquid crystal display.

43. The device of claim 37, wherein the patch unit includes:

a disposable part having the power source and the reservoir, and

a reusable part having at least a portion of the pump, the processor, the user interface and the display,

wherein the patch unit is operable upon connection of the reusable part and the disposable part.

44. The device of claim 43, wherein the disposable part and the reusable part are secured together either in a side by side configuration or a sandwich configuration.

45. The device of claim 37, wherein the patch unit is configured for operation by remote control.

46. The device of claim 37, wherein the patch unit is provided with at least one manual control switch for delivering the therapeutic fluid corresponding to the bolus profile.

47. The device of claim 37, wherein the pump of the patch unit includes a peristaltic mechanism or a piston for delivering the therapeutic fluid into the body of the patient.

48. The device of claim 37, wherein the therapeutic fluid comprises insulin.

49. The device of claim 37, wherein the device further includes a sensor for sensing a bodily analyte level.

50. The device of claim 49, wherein the bodily analyte comprises glucose.

51. The device of claim 37, wherein the cradle includes a well for insertion of a cannula therein.

52. The device of claim 37, wherein the cradle unit comprises:

a cradle base configured as a substantially flat sheet with an adhesive layer for adhering the cradle unit to the skin of the patient and having anchors for connection and disconnection of the patch unit thereto.

53. The device of claim 37, wherein the processor is configured for controlling the patch unit based on a position indication signal received from a position detector, wherein the signal corresponds to whether the patch unit is connected to or disconnected from the cradle unit.

54. The device of claim 37, wherein the processor is configured for programming upon disconnection of the patch unit from the cradle unit.

55. The device of claim 37, wherein the processor is configured to:

receive the one or more inputs and initiate suspending operation of the pump corresponding to the one or more inputs when the patch unit is disconnected from the cradle unit; and

executing operation of the pump upon connection of the patch unit to the cradle unit.

56. The device of claim 55, wherein the, processor is configured for notifying the patient upon execution of the corresponding operation of the pump.

57. The device of claim 37, wherein the operation of the pump corresponds to at least one of the one or more inputs.

58. The device of claim 37, wherein the user interface is configured to operate and control the patch unit.

59. The device of claim 37, wherein the user interface includes at least one of:

buttons, switches, keys, a keypad, icons, graphical objects, voice command receiver and a touch sensitive screen including one or more of the preceding.

60. A method for delivering a therapeutic fluid into a body of a patient using a therapeutic fluid delivery device comprising:

providing a patch unit securable to a cradle unit or to the skin of the patient, the patch unit comprising a reservoir, a pump, a power source, a processor, a user interface and a display;

receiving one or more inputs from the user interface, the one or more inputs corresponding to at least one of a basal rate and a bolus profile;

displaying at least one of an indication of therapeutic fluid flow, a pump operation and the one or more inputs on a display of the patch unit; and

controlling and/or operating the pump according to the one or more inputs.

61. The method of claim 60, wherein the patch unit further includes a cover for substantially covering the display.

62. The method of claim 60, wherein the display is touch sensitive.

63. The method of claim 60, wherein the patch unit includes:

a disposable part having the power source and the reservoir, and

a reusable part having at least a portion of the pump, the processor, the user interface and the display; and

wherein control and/or operation of the pump is established upon coupling the reusable part and the disposable part.

64. The method of claim 60, wherein the cradle unit includes a well for insertion of a cannula therein, a cradle base configured as a substantially flat sheet with an adhesive layer for adhering the cradle unit to the skin of the patient and anchors for connection and disconnection of the patch unit to the cradle unit.

65. The method of claim 60, further comprising receiving an additional input comprising a level of a bodily analyte.

66. The method of claim 60, wherein the display is configured for operation upon the disconnection of the patch unit from the cradle unit and/or the skin of the patient.

67. The method of claim 60, further comprising displaying one or more of:

a bodily analyte level, nutrition values of foods, an amount of carbohydrates, an amount of therapeutic fluid held in the reservoir and at lease one of an amount and percentage of delivered therapeutic fluid.

68. The method of claim 60, wherein the display comprises a liquid crystal display.

69. The method of claim 60, further comprising controlling the patch unit based on a position indication signal received from a position detector, wherein the signal corresponds to whether the patch unit is connected to or disconnected from the cradle unit.

70. The method of claim 60, further comprising programming the processor when the patch unit is disconnected from the cradle unit

71. The method of claim 60, further comprising:

receiving the one or more inputs and suspending operation of the pump corresponding to the one or more inputs when the patch unit is disconnected from the cradle unit; and

executing operation of the pump upon connection of the patch unit to the cradle unit.

72. The method of claim 71, further comprising notifying the patient upon execution of the corresponding operation of the pump.

73. The method of claim 60, wherein the user interface comprises one or more of:

buttons, switches, keys, a keypad, icons, graphical objects, voice command receiver and touch sensitive screen having one or more of the preceding.

74. A method for controlling and/or operating a portable ambulatory, therapeutic fluid delivery device, the method comprising:

providing a patch unit securable to a cradle unit or to the skin of a patient, the patch unit comprising a reservoir, a pump, a power source, a processor, a user interface and a display;

disconnecting the patch unit from the cradle or from the skin of the patient;

displaying on the display at least one of an indication of therapeutic fluid flow and operation of the pump when the patch unit is disconnected from at least one of the cradle unit and from the skin of the patient;

connecting the patch unit to the cradle unit or to the skin of the patient for delivering the therapeutic fluid into the body.

75. The method of claim 74, further comprising programming the processor for controlling the patch unit by using the user interface when the patch unit is disconnected from the cradle unit or from the skin of the patient.

76. The method of claim 75, wherein upon connecting the patch unit, initiating therapeutic fluid delivery in accordance with the programming of the processor.

77. The method of claim 76, comprising notifying the user of initiating therapeutic fluid delivery.

78. The method of claim 77, wherein notifying the user comprises generating at least one of an audible or vibrational notification.

79. The method of claim 75, further comprising suspending fluid delivery when the patch unit is disconnected from at least one of the cradle unit and from the skin of the patient.

80. The method of claim 74, wherein displaying further includes displaying one or more of:

a bodily analyte level, nutrition values of foods, an amount of carbohydrates, an amount of therapeutic fluid held in the reservoir and at least one of an amount and percentage of delivered therapeutic fluid.

81. The method of claim 75, wherein the display comprises a touch sensitive screen, and wherein the touch sensitive screen is used to program the processor.

82. The device of claim 75, wherein the user interface comprises one or more of:

buttons, switches, keys, a keypad, icons, graphical objects, voice command receiver and touch sensitive screen having one or more of the preceding.

83. The method of claim 74, wherein the device further comprises a cover for substantially covering the display.

84. The method of claim 74, wherein connecting the patch unit to at least one of the cradle unit and to the skin of the patient results in the display facing the cradle unit or the skin of the patient.

85. The method of claim 74, further comprising receiving an indication from a position sensor whether the patch unit is connected to or disconnected from the cradle unit or skin of the patient.

86. The method of claim 74, further comprising controlling the patch unit by using a remote control unit.

87. The method of claim 74, wherein the patch unit includes:

a disposable part having the power source and the reservoir, and a reusable part including at least a portion of the pump, the processor, the user interface and the display,

and wherein coupling of the disposable part and reusable part allows operation of at least the display and user interface.