INFUSION PUMP SYSTEM WITH DISPOSABLE CARTRIDGE HAVING PRESSURE VENTING AND PRESSURE FEEDBACK

• US 20110152770A1
• Filed: 07/29/2010
• Published: 06/23/2011
• Est. Priority Date: 07/30/2009
• Status: Abandoned Application

• Current Assignee: Tandem Diabetes Care Incorporated
• Original Assignee: Tandem Diabetes Care Incorporated
• Inventors: Rosinko, Mike, DiPerna, Paul M., Kruse, Geoffrey A., Dabrow, Christopher, Rieger, Kathryn, Bureson, Brian, Williamson, Mark, Ulrich, Thomas R.
• Application Number:
  US12/846,688
• Publication Number:
  US 20110152770A1
• Time in Patent Office: Days
• US Class Current: 604/151
• CPC Class Codes: A61M 2005/14268 with a reusable and a disposable component
• CPC Class Codes: A61M 2205/3389 Continuous level detection A61M2205/3393 takes precedence
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/505 Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 2230/63 Motion, e.g. physical activity
• CPC Class Codes: A61M 5/1413 Modular systems comprising interconnecting elements
• 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 5/16804 Flow controllers
• 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 5/31513 Piston constructions to improve sealing or sliding
• CPC Class Codes: F04B 43/113 the actuating fluid being controlled by at least one valve
• CPC Class Codes: F04B 53/143 Sealing provided on the piston
• CPC Class Codes: F16J 15/32 with elastic sealings, e.g. O-rings
• CPC Class Codes: F16J 15/56 Other sealings for reciprocating rods
• CPC Class Codes: G06F 3/0488 using a touch-screen or digitiser, e.g. input of commands through traced gestures
• CPC Class Codes: G16H 40/63 for local operation

Abstract

Embodiments are directed to portable infusion devices, systems, and methods of using the same for dispensing materials. In some cases, the devices, systems and methods may be used for infusing a material such as medicament, e.g., insulin, into a body in need thereof.

Claims

1. A portable infusion device configured for generating an estimate of an amount of a fluid to be delivered to a body of a user, the device comprising:

a. a processor, coupled to a memory and configured for receiving user input data from the memory and using the input data for generating an estimate of an amount of fluid to be delivered to the body;

b. a memory for receiving and storing user input data coupled to the processor and configured for communicating that data to the processor; and

c. a touch sensitive screen configured for displaying at least one request for user input, where said display is further configured for receiving user input in response to the request and communicating the input to the memory.

2. The portable infusion device of claim 1, wherein the device is further configured for delivering an amount of a fluid to a body of a user.

3. The portable infusion device of claim 2, wherein the device further comprises a reservoir, for storing the fluid, and a delivery mechanism, for effectuating the delivery of the fluid.

4. The portable infusion device of claim 3, wherein the processor is further configured for controlling one or both of the delivery mechanism and reservoir in accordance with the generated estimate of the amount of fluid to be delivered to the body.

5. The portable infusion device of claim 4, wherein the display is further configured for displaying a request for additional user interaction prior to delivering the fluid to the body.

6. The portable infusion device of claim 5, wherein the request for additional user interaction includes one or more of an acceptance of delivery, a rejection of delivery, or a request for more information.

7. The portable infusion device of claim 1, wherein the user input data includes one or more of a blood glucose level, a stress level, a physiological condition, a complexity of a meal to be ingested, an activity level, and user history.

8. The portable infusion device of claim 1, wherein the processor is further configured for receiving non-user entered data and using the non-user entered data in generating the estimate of the amount of fluid to be delivered.

9. The portable infusion device of claim 8, wherein the non-user entered data comprises sensor data.

10. The portable infusion device of claim 9, wherein the sensor data comprises pressure data, which pressure data is used by the processor to determine flow rate data.

11. A portable infusion device configured for generating an estimate of an amount of a fluid to be delivered to a body of a user, the device comprising:

a. a reservoir, for storing the fluid;

b. a delivery mechanism, for effectuating the delivery of the fluid;

c. a processor, coupled to a memory and configured for receiving user input data from the memory and using the input data for generating an estimate of an amount of fluid to be delivered to the body;

d. a memory for receiving and storing user input data coupled to the processor and configured for communicating that data to the processor; and

e. a display configured for displaying a request for a user to input data, wherein the display is further configured for receiving user input data in response to the request and communicating that data to the memory.

12. The portable infusion device of claim 11, wherein the processor is further configured for controlling one or both of the delivery mechanism and reservoir in accordance with the generated estimate of the amount of fluid to be delivered to the body.

13. The portable infusion device of claim 11, wherein the user input data includes one or more of a blood glucose level, a stress level, a physiological condition, a complexity of a meal to be ingested, an activity level, and user history.

14. The portable infusion device of claim 11, wherein the processor is further configured for receiving non-user entered data and using the non-user entered data in generating the estimate of the amount of fluid to be delivered.

15. The portable infusion device of claim 14, wherein the non-user entered data comprises sensor data.

16. The portable infusion device of claim 11, wherein the display is further configured for displaying a request for additional user interaction prior to delivering the fluid to the body.

17. The portable infusion device of claim 16, wherein the request for additional user interaction includes one or more of an acceptance of delivery, a rejection of delivery, or a request for more information.

18. A method for delivering an amount of a fluid to a body of a user, the method comprising:

a. providing a portable infusion device, the portable infusion comprising;

1) a reservoir, for storing the fluid;

2) a delivery mechanism, for delivering the fluid;

3) a processor, for generating an estimate of an amount of fluid to be delivered to the body in response to user input data, and for controlling the delivery mechanism;

4) a data input interface for communicating with the processor, wherein the data input interface is configured for receiving user input data; and

5) a display for displaying the estimate of an amount of a fluid to be delivered;

b. inputting externally supplied values into the data input interface, wherein;

1) the data input interface receives the user input data and communicates that data to the processor;

2) the processor receives the user input data;

3) generates an estimate of an amount of a fluid to be delivered to the body of the user; and

4) communicates the estimate to the display;

c. receiving the generated estimate of an amount of fluid to be delivered on the display of the portable infusion device;

d. receiving a request for a user input on the display of the portable infusion device, wherein the request requires the user to make a selection before delivering the amount of fluid to the body of the user;

e. making a selection based on the estimate;

wherein, once the selection is made the portable infusion device delivers the quantity of fluid to the body in response to the selection.

19. The method of claim 18, wherein the user input data includes one or more of a blood glucose level, a stress level, a physiological condition, a complexity of a meal to be ingested, an activity level, a delivery profile setting, a personal profile setting, and user history.

20. A system for generating an estimate of an amount of fluid to be delivered to a body and delivering the amount of fluid to the body of a user in accordance with the generated estimate, the system comprising:

a. a remote commander, wherein the remote commander comprises;

1) a processor, for generating an estimate of an amount of fluid to be delivered to a body in response to user input data;

2) a data input interface for communicating with the processor, wherein the data input interface is configured for receiving user input data;

3) a memory coupled to the processor;

for receiving and storing user input data;

4) a display for displaying the estimate of an amount of a fluid to be delivered; and

5) a transmitter for transmitting a command to an infuser device, wherein the command instructs the infuser device to deliver an amount of fluid in accordance with the generated and confirmed estimate;

b. a portable infusion device configured for delivering an amount of a fluid to be delivered to a body of a user in accordance with a generated estimate, the device comprising;

1) a reservoir, for storing the fluid;

2) a delivery mechanism, for effectuating the delivery of the fluid;

3) a receiver for receiving the command from the transmitter of the remote commander; and

4) a processor, for instructing the reservoir and delivery mechanism to deliver the amount of fluid to the body of a user in accordance with the generated estimate.

21. A kit, the kit comprising:

a. the system of claim 20; and

b. instructions for using the system.

22. A system for facilitating instructing a user on how to operate a portable infusion device, comprising:

a portable infusion device;

a processor functionally linked to the portable infusion device;

a user-interactive touch screen display functionally linked to the processor;

processor instructions, accessible by the processor, configured to instruct the processor to;

load a program, the program file including data corresponding to an arrangement of at least one of a text and graphic, that when displayed on the user-interactive touch screen display, provides information to the user; and

at least one of the text and graphic displayed on the user-interactive touch screen display is animated.

23. The system of claim 22, wherein the information provided to a user on the user-interactive touch screen display includes one or more of an instruction for use of said portable infusion device, physiological data of a user, and data related to the delivery of a fluid from the portable infusion device.

24. A method of using a portable infusion device to provide information to a user, comprising the steps of;

providing a user with a portable infusion device having a user-interactive touch screen display;

displaying a graphical user interface on said user-interactive touch screen display, where said user-interactive touch screen display displays at least one object relating to at least one of a text and a graphic providing information to a user; and

animating at least one object displayed on said user-interactive touch screen display.

25. The method of claim 24, wherein the information provided to a user on the user-interactive touch screen display includes one or more of an instruction for use of said portable infusion device, physiological data of a user, and data related to the delivery of a fluid from the portable infusion device.

26. A system for facilitating user error prevention of a portable infusion device, comprising:

a portable infusion device;

a processor functionally linked to the portable infusion device;

a user-interactive touch screen display functionally linked to the processor;

processor instructions, accessible by the processor, configured to instruct the processor to;

display a plurality of objects on the user-interactive touch screen display, with at least two objects representing different user input;

allow a user to select at least one displayed object as user input; and

prevent a user from selecting at least one displayed object as user input.

27. The system of claim 26, wherein objects prevented from user selection are visually distinct from displayed objects allowed for user selection, such that a user is able to visually recognize the difference between selectable and non-selectable objects.

28. The system of claim 26, wherein any one of said objects displayed on the user-interactive touch screen display represent at least one of a number, letter, symbol, pictogram, and graph.

29. A method of using a portable infusion device for facilitating user error prevention, comprising the steps of;

displaying a graphical user interface on a user-interactive touch screen display, where said user-interactive touch screen display displays a plurality of objects with at least two objects representing a different user input;

allowing a user to select at least one object as a user input; and

preventing a user from selecting at least one object as user input.

30. The method of claim 29, further comprising displaying objects prevented from user selection being visually distinct from objects allowed for user selection, such that a user is able to recognize the difference between selectable and non-selectable objects.

31. The system of claim 29, wherein any one of said objects displayed on the user-interactive touch screen display represent at least one of a number, letter, symbol, pictogram, and graph.

32. A portable infusion device, said portable infusion device comprising;

a processor functionally linked to the portable infusion device;

a user-interactive touch screen display functionally linked to the processor and having a display area that also operates as a touch input area,

a plurality of touch sensitive modifiable objects representing various information simultaneously displayed in the display area of said user-interactive touch screen display, where said user-interactive touch screen display and processor allow a user to touch any one of said touch sensitive modifiable objects for at least one of viewing, inputting, and modifying information associated with the object touched by said user.

33. The portable infusion device of claim 32, wherein any one of the various information represented by any one of the plurality of touch sensitive modifiable objects include one or more of a blood glucose level, a setting relating to a volume of fluid programmed for delivery, a physiological condition, a complexity of a meal to be ingested, an activity level, a user history, a computation, and a graphical representation of data.

34. A portable infusion device, the device comprising:

(a) a processor that executes instructions for generating an estimate of an amount of fluid for delivery to a body of a user;

(b) a touch sensitive display configured for displaying at least one display object, wherein user interaction with the display object generates a user input value; and

(c) a data interface configured for receiving the user input value from the display in response to user interaction with the display object such that the user input value is communicated from the data interface to the processor for generating the estimate.

35. The portable infusion device of claim 34,wherein the device is further configured for delivering an amount of the fluid to the body of the user.

36. The portable infusion device of claim 35, wherein the device further comprises a fluid interface that receives the fluid, and a delivery mechanism configured for effectuating the delivery of the fluid.

37. The portable infusion device of claim 36, wherein the processor is further configured for controlling one or both of the delivery mechanism and fluid interface in accordance with the generated estimate of the amount of fluid for delivery to the body.

38. The portable infusion device of claim 37, wherein the display is further configured for displaying a request for additional user interaction prior to delivery of the fluid to the body.

39. The portable infusion device of claim 38, wherein the request for additional user interaction comprises user interaction with the touch sensitive display that indicates one or more of an acceptance of delivery, a rejection of delivery, or a request for more information.

40. The portable infusion device of claim 34, wherein the received user input value includes one or more of a blood glucose level, a stress level, a physiological condition, a complexity of a meal to be ingested, an activity level, and user history.

41. The portable infusion device of claim 34, wherein the processor is further configured for receiving non-user entered data and using the non-user entered data in generating the estimate of the amount of the fluid to be delivered.

42. The portable infusion device of claim 41, wherein the non-user entered data comprises sensor data.

43. The portable infusion device of claim 42, wherein the sensor data comprises pressure data, which pressure data is used by the processor to determine flow rate data for the estimate of the amount of the fluid to be delivered.

44. A portable infusion device configured for delivery of a fluid to a body of a user, the device comprising:

(a) a fluid interface for receiving the fluid;

(b) a delivery mechanism for effectuating the delivery of the fluid;

(c) a processor that executes instructions for generating an estimate of an amount of the fluid for delivery;

(d) a touch sensitive display configured for displaying at least one display object, wherein user interaction with the display object generates a user input value; and

(e) a data interface configured for receiving the user input value from the touch sensitive display in response to user interaction with the display object such that the received user input value is communicated from the data interface to the processor for generating the estimate.

45. The portable infusion device of claim 44, wherein the processor is further configured for controlling one or both of the delivery mechanism and fluid interface in accordance with the generated estimate of the amount of fluid to be delivered to the body.

46. The portable infusion device of claim 44, wherein the received user input value includes one or more of a blood glucose level, a stress level, a physiological condition, a complexity of a meal to be ingested, an activity level, and user history.

47. The portable infusion device of claim 44, wherein the processor is further configured for receiving non-user entered data and using the non-user entered data in generating the estimate of the amount of fluid to be delivered.

48. The portable infusion device of claim 47, wherein the non-user entered data comprises sensor data.

49. The portable infusion device of claim 44, wherein the display is further configured for displaying a request for additional user interaction prior to delivering the fluid to the body.

50. The portable infusion device of claim 49, wherein the request for additional user interaction includes one or more of an acceptance of delivery, a rejection of delivery, or a request for more information.

51. A method for delivering an amount of a fluid to a body of a user, the method comprising:

(a) receiving user interaction from a touch sensitive display configured for displaying at least one display object, wherein user interaction with the display object generates a user input value;

(b) generating an estimate of an amount of fluid to be delivered to the body in response to the user input value;

(c) displaying a confirmation display object on the touch sensitive display, wherein the confirmation display object requests a confirmation input from the user for confirmation before delivery of the amount of fluid to the body of the user; and

(d) initiating delivery of the fluid in response to receiving the confirmation input.

52. The method of claim 51, wherein receiving user interaction comprises:

(1) detecting user interaction with a touch screen surface of the touch sensitive display;

(2) determining the user input value in response to the detected user interaction;

(3) providing the determined user input value to a processor for generating the estimate.

53. The method of claim 51, wherein the received user input value includes one or more of a blood glucose level, a stress level, a physiological condition, a complexity of a meal to be ingested, an activity level, a delivery profile setting, a personal profile setting, and user history.

54. A system for generating an estimate of an amount of fluid to be delivered to a body and delivering the amount of fluid to the body of a user in accordance with the generated estimate, the system comprising:

(a) a remote commander comprising;

(1) a display configured for displaying at least one display object, wherein the display object indicates a value such that user interaction with the display object generates a user input value;

(2) a data interface configured for receiving the user input value from the display in response to user interaction with the display;

(3) a processor that receives the user input value from the data interface and generates an estimate of the amount of fluid to be delivered to the body, wherein the processor provides the estimate to the data interface for display of the estimate on the display, and the processor generates an infusion command in response to receiving a confirmation input from the data interface, the confirmation input comprising a user interaction with the display in response to display of a confirmation display object on the display, wherein the confirmation display object requests a confirmation input from the user for confirmation before delivery of the amount of fluid to the body of the user;

(4) a transmitter that transmits the infusion command, the infusion command comprising an instruction for delivery of the amount of the fluid in accordance with the generated estimate and confirmation input;

(b) an infusion device comprising;

(1) a fluid interface configured for receiving the fluid;

(2) a delivery mechanism configured for effectuating the delivery of the fluid;

(3) a receiver configured for receiving the infusion command from the transmitter of the remote commander; and

4) a processor that receives the infusion command from the receiver and initiates delivery of the amount of the fluid from the fluid interface to the body of the user in accordance with the generated estimate.

55. A kit, the kit comprising:

a. the system of claim 54; and

b. instructions for using the system.

56. A system for facilitating instructing a user on how to operate a portable infusion device, the system comprising:

a touch sensitive display configured for displaying at least one display object, such that user interaction with the touch sensitive display generates a user input value;

a processor functionally linked to the touch sensitive display and configured for receiving the user input value; and

a program file for execution by the processor, the program file including data corresponding to an arrangement of at least one of a text and a graphic, such that when the program file is executed by the processor, the at least one of the text and graphic is displayed on the touch sensitive display and provides information to the user about operation of the portable infusion device, wherein the at least one of the text and graphic is animated;

wherein the processor executes the program file in response to the user input value corresponding to a request for the information.

57. The system of claim 56, wherein the information provided to a user on the touch sensitive display includes one or more of an instruction for use of said portable infusion device, physiological data of a user, and data related to the delivery of a fluid from the portable infusion device.

58. A method of providing information to a user of a portable infusion device, the method comprising:

displaying at least one display object on a touch sensitive display of the portable infusion device, the at least one display object relating to at least one of a text and a graphic providing information to the user about the portable infusion device;

detecting user interaction with the touch sensitive display;

responsive to the detected user interaction, animating the at least one display object displayed on the touch sensitive display.

59. The method of claim 58, wherein the information provided to a user on the touch sensitive display includes one or more of an instruction for use of said portable infusion device, physiological data of the user, and data related to the delivery of a fluid from the portable infusion device.

60. A system for facilitating user error prevention of a portable infusion device, comprising:

a touch sensitive display configured for displaying at least one display object, such that user interaction with the display generates a user input value;

a processor functionally linked to the display and configured for receiving the user input value; and

processor instructions, accessible by the processor, configured to instruct the processor to;

display a plurality of objects on the touch sensitive display, the plurality of objects including at least two objects, each of which represents a different user input value;

receive a user selection of one displayed object, the user selection corresponding to a represented user input value;

ignore the received user selection if the represented user input value is not an acceptable value for operation of the portable infusion device, and otherwise accept the received user selection as a user input value for operation of the portable infusion device.

61. The system of claim 60, wherein the processor instructions are further configured to instruct the processor to display at least one of the plurality of objects as a prevented object such that the prevented object is displayed visually distinct from objects that are not a prevented object, wherein a prevented object corresponds to a represented user input value is not an acceptable value for operation of the portable infusion device, such that a user is able to visually recognize a difference between a prevented object and an object that is not a prevented object.

62. The system of claim 60, wherein any one of said objects displayed on the user-interactive touch screen display represent at least one of a number, letter, symbol, pictogram, and graph.

63. A method of using a portable infusion device for facilitating user error prevention, the method comprising:

displaying a plurality of objects on a touch sensitive display of the portable infusion device, the plurality of objects including at least two objects, each of which represents a different user input value;

receiving a user selection of one displayed object on the touch sensitive display, the user selection corresponding to a represented user input value;

ignoring the received user selection if the represented user input value is not an acceptable value for operation of the portable infusion device, and otherwise accepting the received user selection as a user input value for operation of the portable infusion device.

64. The method of claim 63, wherein displaying the plurality of objects further comprises displaying at least one of the plurality of objects as a prevented object such that the prevented object is displayed visually distinct from objects that are not a prevented object, wherein a prevented object corresponds to a represented user input value is not an acceptable value for operation of the portable infusion device, such that a user is able to visually recognize a difference between a prevented object and an object that is not a prevented object.

65. The system of claim 63, wherein any one of said objects displayed on the touch sensitive display represent at least one of a number, letter, symbol, pictogram, and graph.

66. A portable infusion device comprising;

a processor;

a touch screen display functionally linked to the processor and having a display area that operates as a touch input area that detects user interaction therewith,

a plurality of modifiable objects displayed on the touch screen display, the plurality of modifiable objects representing various information simultaneously displayed in the touch input area of said touch screen display, where said touch screen display and processor respond to a user touch to any one of said modifiable objects on the touch screen display for at least one of viewing, inputting, and modifying information associated with the object touched by said user.

67. The portable infusion device of claim 66, wherein any one of the various information represented by any one of the plurality of touch sensitive modifiable objects include one or more of a blood glucose level, a setting relating to a volume of fluid programmed for delivery, a physiological condition, a complexity of a meal to be ingested, an activity level, a user history, a computation, and a graphical representation of data.