Apparatus and methods for tracking administering of medication by medication injection devices

• US 10,518,039 B2
• Filed: 10/25/2016
• Issued: 12/31/2019
• Est. Priority Date: 04/29/2016
• Status: Active Grant

• Current Assignee: Verily Life Sciences LLC (Alphabet Inc.)
• Original Assignee: Verily Life Sciences LLC (Alphabet Inc.)
• Inventors: Mirov, Russell, Krasnow, Benjamin David, Smith, Peter Howard, Deyle, Travis, Schleicher, Brett
• Primary Examiner(s): Stiles, Amber R
• Assistant Examiner(s): Ponton, James D
• Application Number:
  US15/333,770
• Publication Number:
  US 20170312445A1
• Time in Patent Office: 1,162 Days
• CPC Class Codes: A61M 2205/33 Controlling, regulating or measuring
• CPC Class Codes: A61M 2205/3368 Temperature
• CPC Class Codes: A61M 2205/3375 Acoustical, e.g. ultrasonic, measuring means
• CPC Class Codes: A61M 2205/3553 remote, e.g. between patient's home and doctor's office
• CPC Class Codes: A61M 2205/3584 using modem, internet or bluetooth
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/587 Lighting arrangements
• CPC Class Codes: A61M 2205/6054 Magnetic identification systems
• CPC Class Codes: A61M 2205/6063 Optical identification systems
• CPC Class Codes: A61M 2207/00 Methods of manufacture, assembly or production
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 5/142 Pressure infusion, e.g. using pumps
• CPC Class Codes: A61M 5/315 Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
• 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 5/31568 Means keeping track of the total dose administered, e.g. since the cartridge was inserted
• CPC Class Codes: B23P 15/00 Making specific metal objects by operations not covered by a single other subclass or a group in this subclass
• CPC Class Codes: B29C 65/40 Applying molten plastics, e.g. hot melt using welding bar combined with hot gases B29C65/12; by moulding B29C65/70
• CPC Class Codes: B29C 65/54 between pre-assembled parts
• CPC Class Codes: G16H 20/17 : delivered via infusion or injection
• CPC Class Codes: G16H 40/40 : for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
• CPC Class Codes: G16H 40/63 : for local operation
• CPC Class Codes: Y10T 29/4998 : Combined manufacture including applying or shaping of fluent material
• CPC Class Codes: Y10T 29/49993 : Filling of opening

Abstract

Various apparatuses and methods for tracking the administration of medication by medication injection devices are provided. A plunger head for a medication injection device may include a first component that houses electronic components and a second component that couples to the first component to form the plunger head. When the plunger head is installed within a barrel of the medication injection device the second component may separate the first component from medication contained within the barrel.

Claims

1. A plunger head for a medication injection device, comprising:

a first component having a distal end and a proximal end, the distal end being configured for insertion into a barrel of the medication injection device before the proximal end, the first component housing electronic components, wherein the electronic components include;

a transducer positioned proximate to a bottom side of the distal end of the first component, the transducer being configured to emit ultrasonic signals into the barrel of the medication injection device so that the ultrasonic signals travel along the barrel to an end of the barrel and return to the transducer when the plunger head is placed within the medication injection device; and

a microcontroller coupled to the transducer and located between the transducer and the proximal end of the first component, the microcontroller being programmed with instructions to calculate data representative of a quantity of a medication dispensed from the barrel of the medication injection device in response to the ultrasonic signals returning to the transducer; and

a second component at least partially surrounding the first component and separating the first component from the medication contained within the barrel of the medication injection device.

2. The plunger head of claim 1, wherein the second component defines a bucket shape having a cavity at least partially defined by a bottom portion and a radially outer portion of the second component, wherein the first component is positioned within the cavity and the bottom portion of the second component abuts the bottom side of the distal end of the first component.

3. The plunger head of claim 1, further comprising a third component sealing the first component in the second component.

4. The plunger head of claim 1, wherein:

the first component is formed at least partially of a low temperature polymer; and

the second component is formed at least partially of a high temperature elastomer,

wherein the low temperature polymer is a polymer formed and sterilized at or below 60 degrees Celsius, and the high temperature elastomer is an elastomer formed and sterilized above about 60 degrees Celsius.

5. The plunger head of claim 1, wherein:

the first component is at least partially formed of a silicone rubber; and

the second component is formed of butyl rubber.

6. The plunger head of claim 1, wherein the first component includes a structural support system protecting the electronic components and configured to control deformation of the plunger head when a compressive force is applied to the plunger head, the structural support system including a skeleton or a frame that at least partially surrounds the electronic components.

7. The plunger head of claim 1, wherein the second component defines a cavity and the electronic components are disposed within the cavity and an elastomer is disposed in the cavity to form the first component.

8. The plunger head of claim 7, further comprising a third component sealing the first component in the cavity of the second component.

9. The plunger head of claim 1, wherein the electronic components include:

a transceiver; and

a power source,

wherein the microcontroller is programmed with instructions to transmit data to a remote device via the transceiver.

10. The plunger head of claim 9, wherein the transducer, the transceiver, the microcontroller, and the power source are all generally disc shaped and arranged in a pancake like stack configuration, and wherein an acoustical isolation disc separates the transducer from the transceiver, the microcontroller, and the power source.

11. The plunger head of claim 9, wherein the transceiver and the microcontroller are mounted to a printed circuit board, thereby forming a printed circuit board assembly, wherein the printed circuit board is a rigid-flex circuit board.

12. The plunger head of claim 1, wherein the transducer is exposed through the bottom side of the distal end of the first component and mates flush with the second component in order to improve ultrasonic signal performance.

13. The plunger head of claim 1,

wherein the data representative of the quantity of the medication dispensed is calculated by:

measuring a first time period for the ultrasonic signals to travel through the medication in the barrel to the distal end of the barrel and return to the transducer;

calculating a distance the plunger head travels based on the first time period;

recognizing an air shot portion of the distance the plunger head travels as corresponding to an air shot; and

calculating the quantity of the medication dispensed based on the distance the plunger head travels and the air shot portion of the distance the plunger head travels.

14. The plunger head of claim 13, wherein recognizing the air shot portion of the distance the plunger head travels is based upon at least one of:

a second time period between a first dispensing event and a second dispensing event, the first dispensing event corresponding to an air shot volume, an orientation of the plunger head during the first dispensing event, or a pressure decline rate during the first dispensing event.

15. The plunger head of claim 1, wherein the second component encapsulates a portion of the electronic components, and the first component houses a power source electrically connected to the transducer.

16. The plunger head of claim 15, wherein the power source is electrically connected with at least one contact of the electronic components that protrudes from the second component into the first component.

17. The plunger head of claim 1, wherein the electronic components include a power source that is positioned within the first component such that a compressive force applied to the first component can cause the power source to electrically power the transducer.

18. The plunger head of claim 17, wherein the power source is positioned within the first component such that the compressive force applied to the first component can cause the power source to electrically power the transducer by moving the power source into electrical contact with one or more of the electronic components.

19. A medical injection device, comprising:

a barrel having a reflective surface at a barrel distal end thereof, the reflective surface being configured to reflect ultrasonic signals and to permit a medication to pass through; and

a plunger head, comprising;

a first component having a plunger distal end and a proximal end, the plunger distal end being configured for insertion into the barrel of the medication injection device before the proximal end, the first component housing electronic components, including;

a transducer positioned proximate to a bottom side of the plunger distal end of the first component, the transducer being configured to emit ultrasonic signals into the barrel of the medication injection device so that the ultrasonic signals travel along the barrel, reflect off the reflective surface, and return to the transducer; and

a microcontroller coupled to the transducer and located between the transducer and the proximal end of the first component, the microcontroller being programmed with instructions to calculate data representative of a quantity of medication dispensed from the barrel in response to the ultrasonic signals returning to the transducer; and

a second component at least partially surrounding the first component and abutting the bottom side of the plunger distal end of the first component, the second component being configured to separate the first component from a medication contained within the barrel.

20. A medical injection system, comprising:

a remote device configured for use by a medical caregiver; and

a medication injection device, comprising;

a barrel having a reflective surface at a barrel distal end thereof, the reflective surface being configured to reflect ultrasonic signals and to permit a medication to pass through; and

a plunger head configured for insertion into the barrel, the plunger head comprising;

a first component having a plunger distal end and a proximal end, the plunger distal end being configured for insertion into the barrel of the medication injection device before the proximal end, the first component housing electronic components, comprising;

a transducer positioned proximate to a bottom side of the plunger distal end of the first component, the transducer being configured to emit ultrasonic signals into the barrel of the medication injection device so that the ultrasonic signals travel along the barrel to the barrel distal end, reflect off the reflective surface, and return to the transducer;

a microcontroller coupled to the transducer and to the remote device, the microcontroller being located between the transducer and the proximal end of the first component, the microcontroller being programmed with instructions to calculate data representative of a quantity of the medication dispensed from the barrel in response to the ultrasonic signals returning to the transducer and to transmit the data to the remote device; and

a transceiver coupled to the microcontroller; and

a second component at least partially surrounding the first component and abutting the bottom side of the plunger distal end of the first component, the second component being configured to separate the first component from a medication contained within the barrel,

wherein the microcontroller is programmed with instructions to transmit data representative of the quantity of the medication dispensed to the remote device via the transceiver.