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 9,295,777 B2
• Filed: 06/09/2014
• Issued: 03/29/2016
• Est. Priority Date: 11/05/2002
• Status: Active Grant

• Current Assignee: Insulet Corporation
• Original Assignee: Bigfoot Biomedical, Inc.
• Inventors: Mernoe, Morten, Lyngsie, Michael Gorm
• Primary Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US14/299,183
• Publication Number:
  US 20140323957A1
• Time in Patent Office: 659 Days
• Field of Search: 604/131, 604 65- 67, 128/DIG.12, 128/DIG.13
• US Class Current: 1/1
• 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 wearable insulin dispensing device has features and operation characteristics supporting and easing compliance by the users of the device. For example, the device may provide capabilities of rendering a very specific and well-tuned dosage which may be altered according to the specific development of the individual user.

Claims

1. A pump system for dispensing insulin, comprising:

(a) a disposable pump device, comprising;

a wearable pump housing that defines a space to receive an insulin container having a perforatable dispensing end;

a piston rod 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, the piston rod comprising threads on an outer surface portion;

a drive system to advance the piston rod toward the perforatable dispensing end of the insulin container when the insulin container is received in the pump housing, wherein the drive system comprises a toothed wheel, a pawl arranged to engage at least one tooth of the toothed wheel, a spring device for moving the pawl to rotate the toothed wheel, and a battery-powered actuator for creating a spring effect in the spring device, wherein the threads on the outer surface portion of the piston rod mesh with interior threads along an interior circumferential surface of the drive system; and

a battery to supply electrical power for operation of the battery-powered actuator, the battery being positioned inside the wearable pump housing,

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

(b) a controller device that communicates signals to the disposable pump device for controlling a dosage rate of insulin, the controller device having a display, wherein the controller provides closed-loop, fuzzy logic control to cause a new dosage rate of insulin in response to receiving information indicative of glucose level measurements.

2. The pump system of claim 1, wherein the disposable pump device communicates with the controller device via wireless communication signals.

3. The pump system of claim 1, 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.

4. The pump system of claim 1, wherein the disposable pump device further comprises a catheter to communicate the insulin dispensed from the insulin container into a user.

5. The pump system of claim 4, 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.

6. The pump system of claim 5, wherein the disposable pump device further comprises 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.

7. The pump system of claim 1, wherein the battery-powered actuator comprises a shape memory alloy wire that changes length in response to heat.

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

9. The pump system of claim 1, wherein the pump housing is water-tight when the insulin container is received in the is received in the pump housing.

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

11. The pump system of claim 1, further comprising the insulin container that is insertable into the space defined by the wearable pump housing.

12. The pump system of claim 1, wherein the controller device comprises a handheld controller device, and 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 the handheld controller device having said buttons and said display communicates with the disposable pump device.

13. The device of claim 12, 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.

14. The device of claim 13, wherein the insulin container is viewable through the generally transparent window disposed on the wearable pump housing when the disposable pump device dispenses insulin to the user via the catheter tube.

15. The device of claim 14, wherein the handheld controller device is connectable to a computer for transmission of data.

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