EXTENSIBLE INFUSION DEVICES AND RELATED METHODS

• US 20160279336A1
• Filed: 03/26/2015
• Published: 09/29/2016
• Est. Priority Date: 03/26/2015
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Roy, Anirban
• Granted Patent: US 10,449,298 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: A61M 5/20 Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically A61M5/142 , A61M5/46 take precedence; hypodermic projectiles F42B12/54
• CPC Class Codes: A61M 5/24 Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic ampoules or carpules A61J1/06
• CPC Class Codes: A61M 5/31546 Electrically operated dose setting, e.g. input via touch screen or plus/minus buttons
• CPC Class Codes: G16H 20/17 delivered via infusion or injection

Abstract

Fluid injection devices and related systems and operating methods are provided. An exemplary injection device includes an actuation arrangement to facilitate delivering fluid from a container, a user interface element coupled to the actuation arrangement, a data storage element to maintain one or more patient-specific parameter values and historical bolus data, and a control module coupled to the actuation arrangement and the data storage element. The control module of the injection device determines a bolus amount of the fluid to be delivered based at least in part on the one or more patient-specific parameter values and the historical bolus data in response to receiving a user input indicative of a desire to administer a bolus, and the control module configures the actuation arrangement to automatically deliver the bolus amount in response to manual actuation of the user interface element.

Claims

1. An injection device comprising:

an actuation arrangement to facilitate delivering fluid from a container;

a user interface element coupled to the actuation arrangement;

a data storage element to maintain one or more patient-specific parameter values and historical bolus data; and

a control module coupled to the actuation arrangement and the data storage element to;

determine a bolus amount of the fluid based at least in part on the one or more patient-specific parameter values and the historical bolus data in response to receiving a user input indicative of a desire to administer a bolus; and

configure the actuation arrangement to automatically deliver the bolus amount in response to actuation of the user interface element.

2. The injection device of claim 1, wherein:

the actuation arrangement includes a motor operable to displace a plunger within the container;

the control module configures the actuation arrangement to automatically deliver the bolus amount by generating a command for operating the motor to deliver the bolus amount; and

the motor executes the command in response to the actuation of the user interface element.

3. The injection device of claim 1, wherein:

the actuation arrangement includes an adjustable feature to limit displacement of a plunger within the container;

the control module configures the actuation arrangement to automatically deliver the bolus amount by adjusting the adjustable feature to enable displacement of the plunger by an amount corresponding to the bolus amount in response to the actuation of the user interface element.

4. The injection device of claim 1, wherein:

the actuation arrangement includes an autoinjection mechanism; and

the control module configures the autoinjection mechanism to automatically deliver the bolus amount in response to the actuation of the user interface element.

5. The injection device of claim 1, further comprising a communications interface to receive, from a measurement device, a current measurement value for a physiological condition in a body of a patient, wherein the control module is coupled to the communications interface to determine the bolus amount based at least in part on the one or more patient-specific parameter values associated with the patient, the historical bolus data, and the current measurement value.

6. The injection device of claim 5, wherein:

the measurement device comprises a blood glucose meter;

the current measurement value comprises a blood glucose measurement value obtained via the blood glucose meter;

the fluid comprises insulin; and

the control module determines a current insulin on board in the body of the patient based at least in part on the blood glucose measurement value, and determines the bolus amount in a manner that is influenced by the current insulin on board.

7. The injection device of claim 1, the fluid influencing a physiological condition in a body of a patient associated with the one or more patient-specific parameter values, wherein the control module determines an active amount of the fluid in the body of the patient based at least in part on the one or more patient-specific parameter values and the historical bolus data and determines the bolus amount in a manner that is influenced by the active amount.

8. The injection device of claim 7, wherein the historical bolus data includes bolus delivery amounts for boluses previously delivered by the injection device and respective bolus delivery times associated with the respective bolus delivery amounts.

9. The injection device of claim 8, wherein the control module iteratively calculates the active amount based on the respective bolus delivery amounts, the respective bolus delivery times, and the one or more patient-specific parameter values.

10. The injection device of claim 1, further comprising a second user interface element to receive a second user input indicative of a carbohydrate amount, the second user interface element being different from the user interface element, wherein the control module is coupled to the second user interface element to determine the bolus amount of the fluid based at least in part on the one or more patient-specific parameter values, the historical bolus data, and the carbohydrate amount.

11. The injection device of claim 1, wherein the user interface element comprises a delivery button.

12. A method of operating an injection pen to deliver fluid to a patient, the method comprising:

receiving user input indicative of a desire to administer a bolus using the injection pen;

after receiving the user input, determining, by the injection pen, a bolus delivery amount of the fluid based at least in part on one or more parameter values associated with the patient and historical bolus data associated with previous boluses delivered to the patient using the injection pen;

configuring, by the injection pen, an actuation arrangement of the injection pen to automatically deliver the bolus delivery amount in response to actuation of a user interface element of the injection pen.

13. The method of claim 12, further comprising storing, by the injection pen, the historical bolus data, wherein determining the bolus delivery amount comprises the injection pen:

determining an active amount of the fluid in a body of the patient based at least in part on the one or more parameter values and the historical bolus data; and

determining the bolus delivery amount in a manner that is influenced by the active amount.

14. The method of claim 12, further comprising receiving, by the injection pen from a measurement device communicatively coupled to the injection pen, a current measurement value for a physiological condition of the patient influenced by the fluid, wherein determining the bolus delivery amount comprises determining the bolus delivery amount based at least in part on the current measurement value, the one or more parameter values, and the historical bolus data.

15. The method of claim 12, wherein:

configuring the actuation arrangement comprises generating a motor command for operating a motor of the actuation arrangement that corresponds to the bolus delivery amount; and

the motor automatically executes the motor command in response to the actuation of the user interface element of the injection pen.

16. An insulin injection pen comprising:

an actuation arrangement to facilitate delivering insulin from a container to a body of a patient;

a delivery button coupled to the actuation arrangement;

a data storage element to maintain parameter values associated with the patient and historical bolus data for the patient, the parameter values including an insulin action speed and a target glucose value; and

a control module coupled to the actuation arrangement and the data storage element to;

receive a user input indicative of a desire to administer a bolus; and

in response to the user input;

determine a current insulin on board in the body of the patient based at least in part on the historical bolus data and the insulin action speed;

determine a bolus delivery amount of the insulin based at least in part on the current insulin on board and the target glucose value; and

configure the actuation arrangement to automatically deliver the bolus delivery amount of the insulin from the container in response to manual actuation of the delivery button.

17. The insulin injection pen of claim 16, the actuation arrangement including a motor configured to displace a plunger within the container, wherein:

the control module generates a motor command for operating the motor to displace the plunger by a distance corresponding to the bolus delivery amount; and

the motor executes the motor command in response to the manual actuation of the delivery button.

18. The insulin injection pen of claim 16, the actuation arrangement including an autoinjection mechanism, wherein the control module configures the autoinjection mechanism to deliver the bolus delivery amount in response to the manual actuation of the delivery button.

19. The insulin injection pen of claim 16, further comprising a communications interface to receive a current blood glucose measurement value for the patient from a blood glucose meter, wherein the control module is coupled to the communications interface to determine the bolus delivery amount based at least in part on the current insulin on board and a relationship between the target glucose value and the current blood glucose measurement value.

20. The insulin injection pen of claim 16, wherein:

the historical bolus data includes insulin delivery amounts for boluses previously delivered by the insulin injection pen and respective delivery times associated with the respective insulin delivery amounts; and

the control module iteratively calculates the current insulin on board at a time associated with the user input based on the respective insulin delivery amounts, the respective delivery times, and the insulin action speed.