Disposable, wearable insulin dispensing device, a combination of such a device and a programming controller and a method of controlling the operation of such a device

• US 20050273059A1
• Filed: 06/21/2005
• Published: 12/08/2005
• Est. Priority Date: 12/23/2002
• Status: Active Grant

• Current Assignee: Insulet Corporation, M2 Medical Group Holdings, Inc.
• Original Assignee: M2 Medical A/S
• Inventors: Lyngsie, Michael Gorm, Mernoe, Morten
• Granted Patent: US 7,785,288 B2
• Time in Patent Office: Days
• US Class Current: 604/180
• 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 2005/3109 Caps sealing the needle bore by use of, e.g. air-hardening adhesive, elastomer or epoxy resin
• CPC Class Codes: A61M 2005/31518 designed to reduce the overall size of an injection device, e.g. using flexible or pivotally connected chain-like rod members
• CPC Class Codes: A61M 2202/04 Liquids
• CPC Class Codes: A61M 2205/0238 the material being a coating or protective layer
• CPC Class Codes: A61M 2205/0266 Shape memory materials
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2205/581 by audible feedback
• 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 5/14546 Front-loading type injectors
• CPC Class Codes: A61M 5/14566 with a replaceable reservoir for receiving a piston rod of the pump
• 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 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence

Abstract

A disposable, wearable, self-contained insulin dispensing device includes a housing and an insulin source in the housing that is connected to a catheter for injecting insulin into a user. The catheter projects generally perpendicularly to a generally planar surface of the housing configured for abutting a skin surface of the user; which planar surface includes an adhesive layer for adhering the housing surface to the skin surface. A removable release sheet covers the adhesive layer for protecting the adhesive layer prior to use of the device. The release sheet is provided with a catheter protection element to enclose and protect an end portion of the catheter, such that removal of the release sheet for exposing the adhesive layer also exposes the end portion. A pump in the housing includes an actuator employing a shape memory alloy wire.

Claims

1. A disposable, wearable, self-contained medicine dispensing device comprising:

a housing,

a medicine source in said housing,

a pump means in said housing and adapted for pumping medicine from said insulin medicine source to a catheter for injection of said medicine in a user of the device, said catheter being associated with said housing and projecting generally perpendicularly to a generally planar surface of said housing intended for abutting a skin surface of a user of the device,

an adhesive layer provided on said planar surface for adhering said planar surface to said skin surface, and

a removable release sheet covering said adhesive layer for protecting said adhesive layer prior to use of said dispensing device, said release sheet being provided with catheter protection means to enclose and protect an end portion of said catheter such that removal of said release sheet for exposing said adhesive layer exposes said end portion.

2. A dispensing device according to claim 1, wherein said catheter protection means comprises an indentation in said release sheet.

13. A dispensing device according to claim 1, and further comprising:

a combined microphone and loudspeaker associated with said housing, and

recording and play back means connected to said combined microphone and loudspeaker and associated with said housing, such that verbal messages may be recorded and played back by said dispensing device.

19. A dispensing device according to any of claims 1, 3, 4, and 6, wherein the pump means comprises a piston rod for displacing a piston in a cylindrical container of said medicine to be dispensed and an actuator for displacing said piston rod, wherein said piston rod is configured such that the portion of said piston rod between said actuator and said piston is rectilinear and rest of said piston rod is arcuate.

20. A dispensing device according to claim 19, wherein the piston rod comprises elements arranged in a row and interconnected by hinge elements.

21. A dispensing device according to claim 19, wherein each element is provided with a surface spaced from said hinge element and configured to abut a corresponding surface of an adjacent element when said piston rod is rectilinear.

22. A dispensing device according to claim 20, wherein said elements are provided with screw threads on the outer surface thereof for co-operating with corresponding screw threads of the actuator.

23. A dispensing device according to claim 19, wherein the piston rod comprises a strip having an arcuate cross section taken transverse to the longitudinal direction of said strip.

24. A dispensing device according to claim 23, wherein said strip is rectilinear between said actuator and said piston while the rest of the strip is wound into a roll.

25. A dispensing device according to claim 23, wherein said strip is provided with apertures, preferably transversely extending slits, evenly spaced along the length thereof for receiving corresponding projections of said actuator.

3. A disposable, wearable, self-contained medicine dispensing device comprising:

a housing,

a medicine source in said housing,

a pump means in said housing and adapted for pumping medicine from said medicine source to a catheter for injection of said medicine in a user of the device, said catheter being associated with said housing and projecting generally perpendicularly to a generally planar surface of said housing intended for abutting a skin surface of a user of the device,

an adhesive layer provided on said planar surface for adhering said planar surface to said skin surface,

a combined microphone and loudspeaker associated with said housing,

recording and play back means connected to said combined microphone and loudspeaker and associated with said housing, such that verbal messages may be recorded and played back by said dispensing device.

11. A dispensing device according to claim 3, and further comprising:

a removable release sheet covering said adhesive layer for protecting said adhesive layer prior to use of said dispensing device, said release sheet being provided with catheter protection means to enclose and protect an end portion of said catheter such that removal of said release sheet for exposing said adhesive layer exposes said end portion.

12. A dispensing device according to claim 11, wherein said catheter protection means comprises an indentation in said release sheet.

4. A disposable, wearable, self-contained medicine dispensing device comprising:

a housing,

a medicine source in said housing,

a pump means in said housing and adapted for pumping medicine from said medicine source to a catheter for injection of said medicine in a user of the device, and

an actuator for said pump means, said actuator comprising a shape memory alloy wire.

5. A dispensing device according to claim 4, wherein said actuator further comprises a pawl wheel, a pawl adapted for cooperating with said pawl wheel and connected to one end of said shape memory alloy wire and a spring means connected to said pawl, the connections between said pawl and said wire and said pawl and said spring means being such that contraction of said wire rotates said pawl wheel against the spring force of said spring means.

14. A dispensing device according to claim 4, and further comprising controlling means for controlling the operation of said actuator according to a program.

15. A dispensing device according to claim 14, wherein said program comprises a sequence of a certain amount of actuations of said actuator per 24 hour time period.

16. A dispensing device according to claim 14 and further comprising a timing means connected to said controlling means, wherein said program comprises a sequence of actuations of said actuator that varies according to the time of day.

17. A dispensing device according to claim 14 and further comprising

a timing means connected to said controlling means,

an input device for inputting data to said controlling means, said controlling means being programmable by means of said data.

18. A dispensing device according to claim 17, wherein the program of said controlling means comprises algorithms for automatically altering the sequence of actuations of said actuator according to input of data relative to at least one of the actual glucose level in the blood of the user of the device and the intake of nutrients by said user.

32. A dispensing device according to claim 4, and further comprising:

a catheter for injection of said medicine in a user of the device and, said catheter being associated with said housing and projecting generally perpendicularly to a generally planar surface of said housing intended for abutting a skin surface of a user of the device,

an adhesive layer provided on said planar surface for adhering said planar surface to said skin surface, and

a removable release sheet covering said adhesive layer for protecting said adhesive layer prior to use of said dispensing device, said release sheet being provided with catheter protection means to enclose and protect an end portion of said catheter such that removal of said release sheet for exposing said adhesive layer exposes said end portion.

33. A dispensing device according to claim 32, wherein said catheter protection means comprises an indentation in said release sheet.

36. A dispensing device according to claim 4, and further comprising:

a combined microphone and loudspeaker associated with said housing, and

recording and play back means connected to said combined microphone and loudspeaker and associated with said housing, such that verbal messages may be recorded and played back by said dispensing device.

6. A disposable, wearable, self-contained medicine dispensing device comprising

a housing,

a medicine source in said housing,

a pump means in said housing and adapted for pumping medicine from said medicine source to a catheter for injection of said medicine in a user of the device,

an actuator for said pump means, the actuator comprising a shape memory alloy wire, and

controlling means for controlling the operation of said actuator according to a program.

7. A dispensing device according to claim 6, wherein said program comprises a sequence of a certain amount of actuations of said actuator per 24 hour time periods.

8. A dispensing device according to claim 6 and further comprising a timing means connected to said controlling means, wherein said program comprises a sequence of actuations of said actuator that varies according to the time of day.

9. A dispensing device according to claim 6 and further comprising

a timing means connected to said controlling means,

an input device for inputting data to said controlling means, said controlling means being programmable by means of said data.

10. A dispensing device according to claim 9, wherein the program of said controlling means comprises algorithms for automatically altering the sequence of actuations of said actuator according to input of data relative to at least one of the actual glucose level in the blood of the user of the device and the intake of nutrients by said user.

26. A combination of a dispensing device according to claim 6 and a programming controller, said dispensing device and said programming controller comprising cooperating data communication means for mutual communication of data.

27. A combination according to claim 26, wherein said programming controller is selected from the group consisting of at least one of a cellular telephone a personal computer, a laptop computer, and a hand held computer.

34. A dispensing device according to claim 6, and further comprising:

a catheter for injection of said medicine in a user of the device and, said catheter being associated with said housing and projecting generally perpendicularly to a generally planar surface of said housing intended for abutting a skin surface of a user of the device,

an adhesive layer provided on said planar surface for adhering said planar surface to said skin surface, and

a removable release sheet covering said adhesive layer for protecting said adhesive layer prior to use of said dispensing device, said release sheet being provided with catheter protection means to enclose and protect an end portion of said catheter such that removal of said release sheet for exposing said adhesive layer exposes said end portion.

35. A dispensing device according to claim 34, wherein said catheter protection means comprises an indentation in said release sheet.

37. A dispensing device according to claim 6, and further comprising:

a combined microphone and loudspeaker associated with said housing, and

recording and play back means connected to said combined microphone and loudspeaker and associated with said housing, such that verbal messages may be recorded and played back by said dispensing device.

28. A method of controlling the operation of a disposable, wearable, self-contained medicine dispensing device comprising:

a housing,

a medicine source in said housing,

a pump means in said housing and adapted for pumping medicine from said medicine source to a catheter for injection of said medicine in a user of the device,

an actuator for said pump means, the actuator comprising a shape memory alloy wire, and

controlling means for controlling the operation of said actuator according to a program,

said method comprising the step of;

providing said controlling means with data for use in said program during a period beginning prior to and ending after initiation of use of said dispensing device.

29. A method of controlling the operation of a disposable, wearable, self-contained medicine dispensing device comprising;

a housing,

a medicine source in said housing,

a pump means in said housing and adapted for pumping medicine from said medicine source to a catheter for injection of said medicin in a user of the device, said catheter being associated with said housing and projecting generally perpendicularly to a generally planar surface of said housing intended for abutting a skin surface of a user of the device,

an adhesive layer provided on said planar surface for adhering said planar surface to said skin surface,

a combined microphone and loudspeaker associated with said housing,

recording and play back means connected to said combined microphone and loudspeaker and associated with said housing, such that verbal messages may be recorded and played back by said dispensing device, and

manual operating means for manually controlling the operation of said dispensing device, said method comprising the steps of;

recording verbal instructions in said recording means for instructing the user of the device in the operation of said dispensing device, and

playing back said verbal instructions.

30. A method of controlling the operation of a disposable, wearable, self-contained medicine particularly insulin dispensing device comprising:

a housing,

a medicine source in said housing,

a pump means in said housing and adapted for pumping medicine from said medicine source to a catheter for injection of said medicine in a user of the device, said catheter being associated with said housing and projecting generally perpendicularly to a generally planar surface of said housing intended for abutting a skin surface of a user of the device,

an adhesive layer provided on said planar surface for adhering said planar surface to said skin surface,

a combined microphone and loudspeaker associated with said housing,

a programmable computing means associated with said housing, and

signal conversion means connected to said combined microphone and loudspeaker and associated with said housing, and adapted for converting received audio signals into input signals for said computing means and for converting output signals from said computing means to audio signals,

said method comprising the steps of;

transmitting audio signals to said microphone for controlling the operation of said dispensing device, and

receiving audio signals from said loudspeaker for evaluating the operation of said dispensing device.

31. (canceled)