Wearable, self-contained drug infusion device

• US 6,589,229 B1
• Filed: 07/31/2000
• Issued: 07/08/2003
• Est. Priority Date: 07/31/2000
• Status: Expired due to Term

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Powell, Kenneth G., Shermer, Charles D., Connelly, Robert I.
• Primary Examiner(s): Denion, Thomas
• Assistant Examiner(s): CORRIGAN, JAIME W
• Application Number:
  US09/629,977
• Time in Patent Office: 1,072 Days
• Field of Search: 604/21, 604/890.1, 604/65, 604/66, 604/67, 604/117, 604/132, 604/141, 604/138, 604/154, 604/156, 604/179, 600/561
• US Class Current: 604/890.1
• 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 2205/0294 Piezoelectric materials
• CPC Class Codes: A61M 2209/01 Remote controllers for specific apparatus
• CPC Class Codes: A61M 5/14224 Diaphragm type
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/16881 Regulating valves on-off valves, e.g. clamps A61M39/28
• CPC Class Codes: A61M 5/16886 for measuring fluid flow rate, i.e. flowmeters
• CPC Class Codes: Y10S 977/906 Drug delivery

Abstract

A wearable, self contained drug infusion device is disclosed that is capable of achieving the precise flow rate control needed for dose-critical drugs such as insulin. In preferred embodiments of the device, piezoelectrically-actuated valve or pump structures are used in combination with thermal flow sensors and closed-loop control circuits for providing the desired flow rate control. The device has a two-part construction in which the more expensive electronic components are housed in a reusable portion and the fluid delivery components are housed in a separable disposable portion. The invention may also utilize a wireless unit for controlling the operation of the drug infusion device.

Claims

1. A wearable self-contained device for delivering a liquid medication by continuous infusion into a patient, comprising:

a disposable portion comprising a housing, a reservoir in said housing for containing a supply of said liquid medication and for delivering said liquid medication under pressure wherein said reservoir comprises at least one Belleville spring element for pressurizing the liquid medication contained in said reservoir, a delivery cannula carried by said housing, and a flow channel for conducting said liquid medication from said reservoir to said delivery cannula;

a reusable portion removably connected to said disposable portion, said reusable portion comprising a closed loop control circuit for maintaining a predetermined flow of said liquid medication through said flow channel;

a flow control valve in at least one of said disposable and reusable portions for controlling the flow of said liquid medication through said flow channel from said reservoir to said delivery cannula;

an actuator in at least one of said disposable and reusable portions for actuating said flow control valve, said actuator being electrically connectable to said closed loop control circuit; and

a flow sensor in at least one of said disposable and reusable portions for sensing the flow of said liquid medication through said flow channel, said flow sensor being electrically connectable to said closed loop control circuit.

2. A device as claimed in claim 1, wherein said flow control valve comprises a fixed obstruction in said flow channel and a flexible membrane that is held in contact with said obstruction by said actuator to prevent liquid flow through said flow channel except when said actuator is energized by said control circuit.

3. A device as claimed in claim 2, wherein said actuator comprises a piezoelectric element which, when energized by said control circuit, flexes to allow said membrane to separate from said obstruction so that said liquid medication can flow through said flow channel.

4. A device as claimed in claim 3, wherein said piezoelectric element is energized in a pulsatile manner by said control circuit, so that said flow control valve is repeatedly opened and closed with a duty cycle that maintain said predetermined flow of said liquid medication through said flow channel.

5. A device as claimed in claim 1, wherein said flow sensor comprises a thermal emitter and a thermal detector in thermal contact with the liquid medication flowing in said flow channel, said thermal emitter being located upstream of said thermal detector relative to the direction of liquid flow in said flow channel.

6. A device as claimed in claim 1, wherein at least one wall of said flow channel comprises a flexible membrane which forms an exposed face of said disposable portion that is brought into contact with said reusable portion when said disposable and reusable portions are connected together, and wherein said actuator and said flow sensor are contained in said reusable portion and operate through said flexible membrane of said disposable portion so that said flow channel can remain sealed when said reusable portion is disconnected from said disposable portion.

7. A wearable, self-contained device for delivering a liquid medication by continuous infusion into a patient, comprising:

a disposable portion comprising a housing, a reservoir in said housing for containing a supply of said liquid medication, a deli very cannula carried by said housing, and a flow channel for conducting said liquid medication from said reservoir to said delivery cannula;

a reusable portion removably connected to said disposable portion, said reusable portion comprising a closed loop control circuit for maintaining a predetermined flow of said liquid medication through said flow channel;

a pump in at least one of said disposable and reusable portions for pumping said liquid medication through said flow channel from said reservoir to said delivery cannula, said pump being electrically connectable to said closed loop control circuit; and

a flow sensor in at least one of said disposable and reusable portions for sensing the flow of said liquid medication through said flow channel, said flow sensor being electrically connectable to said closed loop control circuit wherein said flow sensor comprises a thermal emitter and a thermal detector in thermal contact with the liquid medication flowing in said flow channel, said thermal emitter being located upstream of said thermal detector relative to the direction of liquid flow in said flow channel.

8. A device as claimed in claim 7, wherein said pump comprises a diaphragm pump in said disposable portion that is driven by an actuator in at least one of said disposable and reusable portion.

9. A device as claimed in claim 8, wherein said actuator comprises a piezoelectric element.

10. A device as claimed in claim 9, wherein said piezoelectric element comprises a cantilevered piezoelectric element.

11. A device as claimed in claim 8, wherein said diaphragm pump comprises at least one check valve for restricting liquid flow to a single direction.

12. A device as claimed in claim 7 wherein at least one wall of said flow channel comprises a flexible membrane which forms an exposed face of said disposable portion that is brought into contact with said reusable portion when said disposable and reusable portions are connected together, and wherein said flow sensor is contained in said reusable portion and operates through said flexible membrane of said disposable portion so that said flow channel can remain sealed when said reusable portion is disconnected from said disposable portion.

13. A system for delivering a liquid medication by continuous infusion into the skin of a patient, comprising:

a disposable portion comprising a housing, a reservoir in said housing for containing a supply of said liquid medication wherein said reservoir comprises at least one Belleville spring element for pressurizing the liquid medication contained in said reservoir, a delivery cannula carried by said housing, and a flow channel for conducting said liquid medication from said reservoir to said delivery cannula;

a reusable portion removably connected to said disposable portion, said reusable portion containing electrical flow control circuitry for controlling the flow of said liquid medication in said flow channel in response to wireless control signs, said reusable and disposable portions when connected to each other constituting a wearable, self-contained infusion device; and

a wireless unit separate from said reusable and disposable portions for transmitting wireless control signals to said reusable portion to control the flow of said liquid medication in said flow channel of said disposable portion.

14. A system as claimed in claim 13, wherein said wireless unit transmits radio frequency control signals to said reusable portion.

15. A system as claimed in claim 13, wherein said wireless unit transmits optical control signals to said reusable portion.

16. A system as claimed in claim 13, wherein said wireless unit includes a keypad and a display device.

17. A system as claimed in claim 13, wherein said wireless unit receives and displays status information transmitted by said reusable portion.

18. A system as claimed in claim 17, wherein said status information is selected from the group consisting of a flow rate of said liquid medication, an amount of time remaining until said reservoir becomes empty, a quantity of liquid medication remaining in said reservoir, a warning of an incorrect flow rate of said liquid medication, and an indication of a battery condition in said reusable portion.