Wearable insulin dispensing device, and a combination of such a device and a programming controller

• US 9,308,319 B2
• Filed: 08/01/2014
• Issued: 04/12/2016
• Est. Priority Date: 11/05/2002
• Status: Active Grant

• Current Assignee: Insulet Corporation
• Original Assignee: Bigfoot Biomedical, Inc.
• Inventors: Lyngsie, Michael Gorm, Mernoe, Morten
• Primary Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US14/449,439
• Publication Number:
  US 20140343496A1
• Time in Patent Office: 620 Days
• Field of Search: 604 65- 67, 604/131, 128/DIG.12, 128/DIG.13
• US Class Current: 1/1
• 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.

Claims

1. A medicine dispensing system, comprising:

a wearable pump housing assembly including a lower portion for releasably coupling with a skin surface, the wearable pump housing assembly configured to house a generally cylindrical insulin reservoir in an interior space such that the generally cylindrical insulin reservoir extends in a longitudinal direction along a length of the wearable pump housing assembly;

a piston rod movably arranged in the housing assembly to dispense insulin from the generally cylindrical insulin reservoir;

a drive system to advance the piston rod toward the generally cylindrical insulin reservoir;

a bolus push button accessible along an exterior of the wearable pump housing assembly so as to activate a bolus dispensing operation in which a bolus dosage of insulin is dispensed from the generally cylindrical insulin reservoir;

a control circuit in the pump housing assembly to communicate drive signals to the drive system to cause the dispensation of the insulin, the control circuit including;

a programmable unit that stores a programmed dosage schedule, and a wireless communication receiver; and

means for wirelessly controlling the control circuit in the pump housing assembly by wirelessly communicating control signals to the control circuit in the pump housing assembly, wherein the wireless controlling means is configured to display information indicative of the programmed dosage schedule and is configured to receive user input of glucose level measurements.

2. The system of claim 1, further comprising an infusion interface catheter that is attachable to the wearable pump housing assembly, the infusion interface catheter being configured to penetrate through the skin surface, wherein the infusion interface catheter communicates insulin dispensed from the insulin reservoir.

3. The system of claim 2, further comprising an adhesive layer coupled to a lower planar surface of the lower portion of the pump housing assembly to secure the pump housing assembly to the skin surface.

4. The system of claim 3, further comprising a removable release sheet to cover the adhesive layer.

5. The system of claim 2, wherein the piston rod comprises a flexible piston rod movably arranged in the housing assembly to adjust from a curved configuration to a generally longitudinally straight configuration so as to dispense medicine from the generally cylindrical insulin reservoir, the flexible piston rod comprising rod segments connected in series by hinge elements, the rod segments having exterior threads on at least a portion of an outer surface.

6. The system of claim 1, wherein the drive system comprises a shape memory alloy wire that changes length in response to heat.

7. The system 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.

8. The system of claim 1, wherein the control circuit communicates the drive signals according to a program that indicates a sequence of a particular amount of actuations of the drive system over a period of time.

9. The system of claim 8, wherein the program indicates a sequence of actuations of the drive system that varies according to the time of day.

10. The system of claim 9, wherein the program is indicative of the programmed dosage schedule and is stored in the programmable unit of the control circuit, the program being alterable by input on a user interface of the wireless controlling means.

11. The system of claim 1, wherein the wireless controlling means comprises a portable phone device.

12. The system of claim 1, wherein the wireless controlling means comprises a personal computer device.

13. The system of claim 1, wherein the wireless controlling means comprises a laptop computer device.

14. The system of claim 1, wherein the wireless controlling means comprises a handheld computing device.

15. The system of claim 1, wherein the piston rod comprises a flexible piston rod movably arranged in the housing assembly to adjust from a curved configuration to a generally longitudinally straight configuration so as to dispense medicine from the generally cylindrical insulin reservoir, the flexible piston rod comprising rod segments connected in series by hinge elements, the rod segments having exterior threads on at least a portion of an outer surface.

16. The system of claim 15, wherein the exterior threads of the rod segments cooperate with corresponding screw threads of a component of the drive system.

17. The system of claim 15, wherein the rod segments and hinge elements are integrally molded as a unitary structure from a plastic material.

18. The system of claim 1, wherein the housing assembly provides water-tight containment for the generally cylindrical insulin reservoir.

19. The system of claim 1, further comprising the generally cylindrical insulin reservoir mounted within the housing assembly.

20. The system of claim 1, further comprising an audio speaker coupled to the wearable pump housing assembly for emitting sounds in response to actuation of the bolus push button.