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 20100256565A1
• Filed: 06/18/2010
• Published: 10/07/2010
• Est. Priority Date: 12/23/2002
• Status: Active Grant

• Current Assignee: Insulet Corporation
• Original Assignee: Asante Solutions, Inc
• Inventors: Lyngsie, Michael Gorm, Mernøe, Morten
• Granted Patent: US 8,469,920 B2
• Time in Patent Office: Days
• US Class Current: 604/152
• 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 for releasably coupling with a skin surface, the wearable pump housing defining an opening to slideably receive a generally cylindrical insulin cartridge in an interior space such that the generally cylindrical insulin cartridge extends along a substantial majority of a length of the wearable pump housing when received in the interior space of the pump housing;

a piston rod movably arranged in the housing to dispense insulin from the generally cylindrical insulin cartridge when the cartridge is when received in the interior space of the pump housing;

a drive actuator to advance the piston rod toward the generally cylindrical insulin cartridge when the cartridge is when received in the interior space of the pump housing;

a bolus push button arranged on the wearable pump housing so as to activate a bolus dispensing operation in which a bolus dosage of insulin is dispensed from the generally cylindrical insulin cartridge;

an audio speaker coupled to the wearable pump housing for emitting sounds upon manipulation of the bolus push button;

a control circuit in the pump housing to communicate drive signals to the drive actuator to cause the dispensation of the medicine, the control circuit including;

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

a wireless controller to communicate signals to the control circuit in the pump housing indicative of the programmed dosage schedule, wherein the wireless controller includes a user interface having a display screen and a plurality of buttons 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 after the generally cylindrical insulin cartridge is received in the interior space of the pump housing, the infusion interface catheter being adhesively attachable to the skin surface, wherein the infusion interface catheter communicates insulin dispensed from the insulin cartridge.

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

4. The system of claim 3, 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.

5. The system of claim 2, wherein the piston rod comprises a flexible piston rod movably arranged in the housing to adjust from a curved configuration to a rigid configuration so as to dispense medicine from the generally cylindrical insulin cartridge when the cartridge is received in the interior space of the pump housing, 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 actuator comprises a shape memory alloy wire that changes length in response to heat.

7. The system of claim 1, wherein the drive actuator 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 actuator over a period of time.

9. The system of claim 8, wherein the program indicates a sequence of actuations of the drive actuator 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 the user interface of the wireless controller.

11. The system of claim 1, wherein the wireless controller comprises a cellular phone device.

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

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

14. The system of claim 1, wherein the wireless controller comprises a handheld computer device.

15. The system of claim 1, wherein the piston rod comprises a flexible piston rod movably arranged in the housing to adjust from a curved configuration to a rigid configuration so as to dispense medicine from the generally cylindrical insulin cartridge when the cartridge is received in the interior space of the pump housing, 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 actuator.

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 pump housing is water-tight when the carpule is received in the is received in the pump housing.