Electronic injector

• US 8,979,799 B1
• Filed: 12/19/2013
• Issued: 03/17/2015
• Est. Priority Date: 10/14/2013
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Askarinya, Mohsen, Brown, Richard L., Chong, Colin A., Schulhauser, Randal, Kinzie, Patrick W., Cherry, Jeff M., Stevenson, Tyler S.
• Primary Examiner(s): Stigell, Theodore
• Assistant Examiner(s): STILES, AMBER R.
• Application Number:
  US14/134,787
• Time in Patent Office: 453 Days
• Field of Search: 604131-132, 604/151, 604/153, 604180-181, 604/183, 604/185, 604/214, 604/246, 604/513, 604/174
• US Class Current: 604/151
• CPC Class Codes: A61M 2005/14506 mechanically driven, e.g. spring or clockwork
• CPC Class Codes: A61M 2005/1585 Needle inserters
• CPC Class Codes: A61M 2005/1586 Holding accessories for holding infusion needles on the body
• CPC Class Codes: A61M 2205/825 using mechanical generation of electricity, e.g. hand cranked generators
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/145 using pressurised reservoirs, e.g. pressurised by means of pistons

Abstract

An electronic injector including an electronic on-body injector for use with a patient to deliver a fluid through an injection device. The electronic on-body injector includes a fluid reservoir; a MEMS pump; a bolus injection needle, the bolus injection needle having a bolus injection needle tip aligned with the injection port, the bolus injection needle being slideably biased away from the injection port to define a gap; and a bolus needle button operably connected to the bolus injection needle to slide the bolus injection needle along the injection axis. The bolus needle button is operable to advance the bolus injection needle tip to close the gap and advance the bolus injection needle tip into the injection port to form a bolus injection flow path. The bolus needle button is further operable to activate the MEMS pump to deliver a predetermined bolus volume.

Claims

1. An electronic on-body injector for use with a patient to deliver a fluid through an injection device having an injection port in fluid communication with a delivery tube, the injection port lying on an injection axis, the electronic on-body injector comprising:

a fluid reservoir operable to hold the fluid;

a MEMS pump in fluid communication with the fluid reservoir;

a bolus injection needle in fluid communication with the MEMS pump, the bolus injection needle having a bolus injection needle tip aligned with the injection port, the bolus injection needle being slideably biased away from the injection port to define a gap between the bolus injection needle tip and the injection port; and

a bolus needle button operably connected to the bolus injection needle to slide the bolus injection needle along the injection axis;

wherein the bolus needle button is operable to advance the bolus injection needle tip to close the gap and advance the bolus injection needle tip into the injection port to form a bolus injection flow path from the fluid reservoir, through the MEMS pump, through the bolus injection needle, through the delivery tube, and into the patient; and

wherein the bolus needle button is further operable to activate the MEMS pump to deliver a predetermined bolus volume to the patient through the bolus injection flow path in response to a bolus pump drive signal.

2. The electronic on-body injector of claim 1 wherein the MEMS pump is further in fluid communication with the delivery tube to form a basal injection flow path from the fluid reservoir, through the MEMS pump, through the delivery tube, and into the patient, the MEMS pump being further operable to deliver a basal injection to the patient through the basal injection flow path in response to a basal pump drive signal.

3. The electronic on-body injector of claim 1 further comprising:

a battery having a DC power output;

a regulator operably connected to the battery to convert the DC power output to the bolus pump drive signal in response to a regulator control signal; and

a microcontroller operably connected to the regulator to provide the regulator control signal;

wherein the MEMS pump is responsive to the bolus pump drive signal to control flow of the fluid from the MEMS pump through the bolus injection flow path.

4. The electronic on-body injector of claim 1 wherein the MEMS pump is a piezoelectric MEMS pump comprising:

a case defining a working chamber, the working chamber having a piezoelectric wall responsive to a first pump drive signal voltage and a second pump drive signal voltage;

a one way inlet valve operable to permit flow of the fluid from the fluid reservoir to the working chamber and to block reverse flow of the fluid from the working chamber to the fluid reservoir; and

a one way outlet valve operable to permit flow of the fluid from the working chamber to the bolus injection needle and to block reverse flow of the fluid from the bolus injection needle to the working chamber;

wherein the piezoelectric wall increases volume of the working chamber in response to the first pump drive signal voltage to draw the fluid from the fluid reservoir through the one way inlet valve to the working chamber; and

wherein the piezoelectric wall decreases the volume of the working chamber in response to the second pump drive signal voltage to force the fluid from the working chamber through the one way outlet valve to the bolus injection needle.

5. The electronic on-body injector of claim 1 wherein the MEMS pump is selected from the group consisting of a bimetallic pump, an electrostatic pump, a thermopneumatic pump, an electromagnetic pump, and a phase change pump.

6. The electronic on-body injector of claim 1 wherein the bolus pump drive signal is a sine wave having a predetermined duration.

7. An electronic on-body injector for use with a patient to deliver a fluid through an injection device having a delivery tube, the electronic on-body injector comprising:

a fluid reservoir operable to hold the fluid; and

a MEMS pump in fluid communication with the fluid reservoir and the delivery tube to form a basal injection flow path from the fluid reservoir, through the MEMS pump, through the delivery tube, and into the patient;

wherein the MEMS pump is operable to deliver a basal injection to the patient through the basal injection flow path in response to a basal pump drive signal; and

wherein the MEMS pump is a piezoelectric MEMS pump comprising;

a case defining a working chamber, the working chamber having a piezoelectric wall responsive to a first pump drive signal voltage and a second pump drive signal voltage;

a one way inlet valve operable to permit flow of the fluid from the fluid reservoir to the working chamber and to block reverse flow of the fluid from the working chamber to the fluid reservoir; and

a one way outlet valve operable to permit flow of the fluid from the working chamber to the delivery tube and to block reverse flow of the fluid from delivery tube to the working chamber;

wherein the piezoelectric wall increases volume of the working chamber in response to the first pump drive signal voltage to draw the fluid from the fluid reservoir through the one way inlet valve to the working chamber; and

wherein the piezoelectric wall decreases the volume of the working chamber in response to the second pump drive signal voltage to force the fluid from the working chamber through the one way outlet valve to the delivery tube.

8. The electronic on-body injector of claim 7 wherein the injection device further comprises an injection port in fluid communication with the delivery tube, the injection port lying on an injection axis, the electronic on-body injector further comprising:

a bolus injection needle in fluid communication with the MEMS pump, the bolus injection needle having a bolus injection needle tip aligned with the injection port, the bolus injection needle being slideably biased away from the injection port to define a gap between the bolus injection needle tip and the injection port; and

a bolus needle button operably connected to the bolus injection needle to slide the bolus injection needle along the injection axis;

wherein the bolus needle button is operable to advance the bolus injection needle tip to close the gap and advance the bolus injection needle tip into the injection port to form a bolus injection flow path from the fluid reservoir, through the MEMS pump, through the bolus injection needle, through the delivery tube, and into the patient; and

wherein the bolus needle button is further operable to activate the MEMS pump to deliver a predetermined bolus volume to the patient through the bolus injection flow path in response to a bolus pump drive signal.

9. The electronic on-body injector of claim 7 further comprising:

a battery having a DC power output;

a regulator operably connected to the battery to convert the DC power output to the basal pump drive signal in response to a regulator control signal; and

a microcontroller operably connected to the regulator to provide the regulator control signal;

wherein the MEMS pump is responsive to the basal pump drive signal to control flow of the fluid from the MEMS pump through the basal injection flow path.

10. The electronic on-body injector of claim 7 wherein the MEMS pump is selected from the group consisting of a bimetallic pump, an electrostatic pump, a thermopneumatic pump, an electromagnetic pump, and a phase change pump.

11. The electronic on-body injector of claim 7 wherein the basal pump drive signal is a continuous basal pump drive signal.

12. An electronic injector for use with a patient to deliver a fluid, the electronic injector comprising:

a fluid reservoir operable to hold the fluid;

a MEMS pump in fluid communication with the fluid reservoir;

a needle fitting adapted to receive an injection needle, the needle fitting being in fluid communication with the MEMS pump;

a battery having a DC power output;

a regulator operably connected to the battery to convert the DC power output to a pump drive signal in response to a regulator control signal;

a microcontroller operably connected to the regulator to provide the regulator control signal; and

a housing to enclose the battery, the regulator, the microcontroller, the fluid reservoir, and the MEMS pump;

wherein the MEMS pump is responsive to the pump drive signal to control flow of the fluid from the fluid reservoir, through the MEMS pump, through the injection needle, and into the patient; and

wherein the housing has a pen form factor.

13. The electronic injector of claim 12 further comprising an adhesive patch operable to secure the housing to the patient.

14. The electronic injector of claim 12 wherein the MEMS pump is a piezoelectric MEMS pump comprising:

a case defining a working chamber, the working chamber having a piezoelectric wall responsive to a first pump drive signal voltage and a second pump drive signal voltage;

a one way inlet valve operable to permit flow of the fluid from the fluid reservoir to the working chamber and to block reverse flow of the fluid from the working chamber to the fluid reservoir; and

a one way outlet valve operable to permit flow of the fluid from the working chamber to the needle fitting and to block reverse flow of the fluid from the needle fitting to the working chamber;

wherein the piezoelectric wall increases volume of the working chamber in response to the first pump drive signal voltage to draw the fluid from the fluid reservoir through the one way inlet valve to the working chamber; and

wherein the piezoelectric wall decreases the volume of the working chamber in response to the second pump drive signal voltage to force the fluid from the working chamber through the one way outlet valve to the needle fitting.

15. The electronic injector of claim 12 wherein the MEMS pump is selected from the group consisting of a bimetallic pump, an electrostatic pump, a thermopneumatic pump, an electromagnetic pump, and a phase change pump.

16. The electronic injector of claim 12 wherein the injection needle is detachable from the needle fitting.

17. The electronic injector of claim 12 wherein the pump drive signal is a sine wave having a predetermined duration.