On-body injector and method of use

• US 9,539,386 B2
• Filed: 01/15/2016
• Issued: 01/10/2017
• 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., Kinzie, Patrick W., Schulhauser, Randal, Cherry, Jeff M., Stevenson, Tyler S.
• Primary Examiner(s): Stigell, Theodore
• Assistant Examiner(s): STILES, AMBER R.
• Application Number:
  US14/997,068
• Publication Number:
  US 20160129178A1
• Time in Patent Office: 361 Days
• US Class Current: 1/1
• CPC Class Codes: A61M 2005/14252 with needle insertion means
• 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 2005/1726 the body parameters being measured at, or proximate to, the infusion site
• CPC Class Codes: A61M 2039/0205 for injecting media
• CPC Class Codes: A61M 2205/0244 Micromachined materials, e.g. made from silicon wafers, microelectromechanical systems [MEMS] or comprising nanotechnology
• CPC Class Codes: A61M 2205/0294 Piezoelectric materials
• CPC Class Codes: A61M 2205/825 using mechanical generation of electricity, e.g. hand cranked generators
• CPC Class Codes: A61M 39/02 Access sites
• CPC Class Codes: A61M 39/0247 Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body peritoneal dialysis catheters A61M1/285; tracheostomy devices A61M16/0465; measuring pressure within the body A61B5/03; colostomy devices A61F5/445; gastrotomy feeding tubes A61J15/0015; means for fixing a feeding tube outside of the body A61J15/0053
• 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
• CPC Class Codes: A61M 5/1483 using flexible bags externally pressurised by fluid pressure
• CPC Class Codes: A61M 5/152 pressurised by contraction of elastic reservoirs containers for dispensing contents by contraction of an elastic bag provided therein, in general B65D83/0061
• 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 5/16804 Flow controllers
• CPC Class Codes: A61M 5/16813 by controlling the degree of opening of the flow line
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence
• CPC Class Codes: A61M 5/31511 Piston or piston-rod constructions, e.g. connection of piston with piston-rod A61M5/5066 takes precedence
• CPC Class Codes: A61M 5/3287 Accessories for bringing the needle into the body; Automatic needle insertion A61M5/20, A61M5/31525 take precedence
• CPC Class Codes: A61M 5/484 : Regulating injection pressure

Abstract

An on-body injector and method of use including an on-body injector for use with an injection device. The on-body injector includes a bolus reservoir; a bolus injection needle in fluid communication with the bolus reservoir, 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 button operably connected to the bolus injection needle to slide the bolus injection needle along the injection axis. The 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. The button is further operable to advance a plunger through the bolus reservoir to deliver a predetermined bolus volume to the patient through the injection flow path.

Claims

1. 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;

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;

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;

the electronic injector further comprising;

an injection port in fluid communication with a delivery tube, the injection port lying on an injection axis;

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

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

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

wherein the 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 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 injector of claim 1, wherein the housing has a pen form factor.

4. The electronic injector of claim 1, wherein the housing has a card form factor.

5. The electronic injector of claim 1, further comprising an adhesive patch operable to secure the housing to the patient.

6. 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;

wherein the injection needle is detachable from the needle fitting;

the electronic injector further comprising;

an injection port in fluid communication with a delivery tube, the injection port lying on an injection axis;

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

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

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

wherein the 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.

7. The electronic injector of claim 6, 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.

8. The electronic injector of claim 6, wherein the housing has a pen form factor.

9. The electronic injector of claim 6, wherein the housing has a card form factor.

10. The electronic injector of claim 6, further comprising an adhesive patch operable to secure the housing to the patient.

11. 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;

wherein the pump drive signal is a sine wave having a predetermined duration;

the electronic injector further comprising;

an injection port in fluid communication with a delivery tube, the injection port lying on an injection axis;

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

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

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

wherein the 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.

12. The electronic injector of claim 11, 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.

13. The electronic injector of claim 11, wherein the housing has a pen form factor.

14. The electronic injector of claim 11, wherein the housing has a card form factor.

15. The electronic injector of claim 11, further comprising an adhesive patch operable to secure the housing to the patient.