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 7,887,511 B2
• Filed: 05/04/2005
• Issued: 02/15/2011
• Est. Priority Date: 11/05/2002
• Status: Active Grant

• Current Assignee: Insulet Corporation, M2 Medical Group Holdings, Inc.
• Original Assignee: Asante Solutions, Inc
• Inventors: Lyngsie, Michael Gorm, Mernøe, Morten
• Primary Examiner(s): Mendez; Manuel A
• Application Number:
  US11/121,708
• Publication Number:
  US 20050245878A1
• Time in Patent Office: 2,113 Days
• Field of Search: 604/890.1, 604 65- 67, 604/131, 128/DIG.12, 128/DIG.13
• US Class Current: 604/131
• 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 2205/0266 Shape memory materials
• CPC Class Codes: A61M 2205/3553 remote, e.g. between patient's home and doctor's office
• CPC Class Codes: A61M 2205/3576 with non implanted data transmission devices, e.g. using external transmitter or receiver
• CPC Class Codes: A61M 2205/3584 using modem, internet or bluetooth
• CPC Class Codes: A61M 5/14248 of the skin patch type
• 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: G16H 20/17 delivered via infusion or injection

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 pump device for dispensing insulin, comprising:

a wearable pump housing that defines a space to receive a separate container;

an insulin container that is insertable into the space defined by the wearable pump housing, the insulin container having a perforatable dispensing end through which insulin is to be dispensed;

a piston rod comprising screw threads on an outer surface portion, the piston rod being movably arranged in the wearable pump housing to dispense the insulin from the insulin container when the insulin container is inserted in the wearable pump housing;

a drive system to advance the piston rod toward the insulin container and thereby dispense the insulin when the insulin container is inserted in the wearable pump housing; and

a battery to supply electrical power for operation of the disposable pump device, the battery being positioned inside the wearable pump housing,

wherein the entire pump device is disposable and non-reusable.

2. The device of claim 1, wherein the disposable pump device communicates with a controller device having buttons and a display.

3. The device of claim 2, wherein the disposable pump device communicates with a controller device via wireless communication signals.

4. The device of claim 2, wherein the controller device comprises at least one of a cellular phone device, a personal computer device, a laptop computer device, or a handheld computer device.

5. The device of claim 1, further comprising a button interface associated with the wearable pump housing that is configured to activate a bolus operation for dispensing the insulin from the insulin container.

6. The device of claim 1, wherein the wearable pump housing is water-tight when the insulin container is inserted in the is received in the wearable pump housing.

7. The device of claim 1, further comprising a catheter to communicate the insulin dispensed from the insulin container into a user.

8. The device of claim 7, wherein the catheter projects generally perpendicular to a generally planar surface of the pump housing, further comprising an adhesive layer coupled to the generally planar surface of the pump housing to adhere the pump housing to skin of the user.

9. The device of claim 8, further comprising a removable release sheet to cover the adhesive layer, the release sheet including a catheter protection structure that at least partially encloses an end portion of the catheter when the release sheet covers the adhesive layer.

10. The device of claim 1, wherein the drive system comprises a gear wheel, a pawl arranged to engage at least one tooth of the gear wheel, and a spring device coupled to the pawl so as to urge the pawl to rotate the gear wheel.

11. The device of claim 1, wherein the drive system includes a shape memory alloy actuator.

12. The device of claim 1, wherein the wearable pump housing is wearable on the skin of a user.

13. The device of claim 1, further comprising a transparent window portion arranged on the wearable pump housing to view the insulin container when the insulin container is inserted in the wearable pump housing.

14. The device of claim 1, wherein the wearable pump housing of the disposable pump device is wearable on a user'"'"'s body and dispenses insulin to the user via a catheter tube while a handheld controller device having a user-interface buttons and a display communicates with the disposable pump device.

15. The device of claim 14, wherein the wearable pump housing is water-tight when the insulin container received the wearable pump housing outputs insulin through the catheter tube to the user.

16. The device of claim 15, wherein the insulin container is viewable through a generally transparent window portion disposed on the wearable pump housing when the disposable pump device dispenses insulin to the user via the catheter tube.

17. The device of claim 16, wherein the handheld controller device receives user input indicative of glucose level measurement results.

18. The device of claim 1, wherein the wearable pump housing defines the space to slidably receive a generally cylindrical container through an opening in the wearable pump housing, wherein the piston rod comprises a generally cylindrical body portion having the screw threads on the outer surface portion of the generally cylindrical body portion, wherein the drive system is positioned inside the wearable pump housing, and wherein the wearable pump housing includes one or more structures that hinder removal of the insulin container and connection with a subsequent insulin container.

19. The device of claim 18, wherein the disposable pump device communicates with a controller device having buttons and a display.

20. The device of claim 18, wherein the disposable pump device dispenses insulin to the user at a new dosage rate in response to user input indicative of glucose level measurement results.

21. The device of claim 18, further comprising a button interface associated with the wearable pump housing that is configured to activate a bolus operation for dispensing the insulin from the insulin container.

22. The device of claim 18, wherein the drive system comprises a gear wheel, a pawl arranged to engage at least one tooth of the gear wheel, and a spring device coupled to the pawl so as to urge the pawl to rotate the gear wheel.

23. The device of claim 18, wherein the wearable pump housing of the disposable pump device is wearable on a user'"'"'s body and dispenses insulin to the user via a catheter tube while a handheld controller device having a user-interface buttons and a display communicates with the disposable pump device, wherein the insulin container is viewable through a generally transparent window portion disposed on the wearable pump housing when the disposable pump device dispenses insulin to the user via the catheter tube.

24. A disposable pump device for dispensing insulin, comprising:

a wearable pump housing that defines a space to receive a separate container;

an insulin container that is insertable into the space defined by the wearable pump housing, the insulin container having a perforatable dispensing end through which insulin is to be dispensed;

a piston rod comprising screw threads on an outer surface portion, the piston rod being movably arranged in the wearable pump housing to dispense the insulin from the insulin container when the insulin container is inserted in the wearable pump housing;

a drive system to advance the piston rod toward the insulin container and thereby dispense the insulin when the insulin container is inserted in the wearable pump housing; and

a battery to supply electrical power for operation of the disposable pump device, the battery being positioned inside the wearable pump housing,

wherein the entire pump device is disposable and non-reusable,

wherein the wearable pump housing of the disposable pump device is wearable on a user'"'"'s body and dispenses insulin to the user via a catheter tube while a handheld controller device having a user-interface buttons and a display communicates with the disposable pump device,

wherein the wearable pump housing is water-tight when the insulin container received the wearable pump housing outputs insulin through the catheter tube to the user,

wherein the insulin container is viewable through a generally transparent window portion disposed on the wearable pump housing when the disposable pump device dispenses insulin to the user via the catheter tube, and

wherein the handheld controller device that is connectable to a computer for transmission of data.

25. The device of claim 24, further comprising a button interface associated with the wearable pump housing that is configured to activate a bolus operation for dispensing the insulin from the insulin container.

26. The device of claim 24, wherein the drive system comprises a gear wheel, a pawl arranged to engage at least one tooth of the gear wheel, and a spring device coupled to the pawl so as to urge the pawl to rotate the gear wheel.

27. A disposable pump device for dispensing insulin, comprising:

a wearable pump housing that defines a space to receive a separate container;

an insulin container that is insertable into the space defined by the wearable pump housing, the insulin container having a perforatable dispensing end through which insulin is to be dispensed;

a piston rod comprising screw threads on an outer surface portion, the piston rod being movably arranged in the wearable pump housing to dispense the insulin from the insulin container when the insulin container is inserted in the wearable pump housing;

a drive system to advance the piston rod toward the insulin container and thereby dispense the insulin when the insulin container is inserted in the wearable pump housing; and

a battery to supply electrical power for operation of the disposable pump device, the battery being positioned inside the wearable pump housing,

wherein the entire pump device is disposable and non-reusable,

wherein the wearable pump housing of the disposable pump device is wearable on a user'"'"'s body and dispenses insulin to the user via a catheter tube while a handheld controller device having a user-interface buttons and a display communicates with the disposable pump device,

wherein the wearable pump housing is water-tight when the insulin container received the wearable pump housing outputs insulin through the catheter tube to the user,

wherein the insulin container is viewable through a generally transparent window portion disposed on the wearable pump housing when the disposable pump device dispenses insulin to the user via the catheter tube,

wherein the handheld controller device receives user input indicative of glucose level measurement results, and

wherein the disposable pump device dispenses insulin to the user at a new dosage rate in response to the user input indicative of glucose level measurement results.

28. The device of claim 27, further comprising a button interface associated with the wearable pump housing that is configured to activate a bolus operation for dispensing the insulin from the insulin container.

29. The device of claim 27, wherein the drive system comprises a gear wheel, a pawl arranged to engage at least one tooth of the gear wheel, and a spring device coupled to the pawl so as to urge the pawl to rotate the gear wheel.