US-12623016-B2 - Pressure management method for a drug delivery device

Abstract

A method of pressure management for a drug delivery device including a pump, a fluid line, and a power source, includes: delivering fluid through the fluid line via the pump; determining a parameter indicative of pressure within the fluid line; determining whether the parameter indicative of pressure within the fluid line exceeds a pressure threshold level; pausing the delivery of fluid through the fluid line until a predetermined condition is satisfied; and resuming the delivery of the fluid through the fluid line after the predetermined condition is satisfied.

Inventors

• Jean-Marc Volle
• Steve Beguin
• Simon O'Reilly
• Raphael Marcelpoil
• Cedrick Orny

Assignees

• BECTON, DICKINSON AND COMPANY

Dates

Publication Date

20260512

Application Date

20211116

Claims (20)

1. 1 . A method of pressure management for a drug delivery device comprising a pump, a fluid line, and a power source, the method comprising: a) delivering fluid through the fluid line via the pump; b) determining a parameter indicative of pressure within the fluid line; c) determining whether the parameter is indicative of pressure within the fluid line exceeds a pressure threshold level; d) pausing the delivery of fluid through the fluid line until a predetermined condition is satisfied; and e) resuming the delivery of the fluid through the fluid line after the predetermined condition is satisfied, wherein the parameter indicative of pressure within the fluid line is determined by measuring a current of the drug delivery device during actuation of the pump, and wherein the measuring of the current of the drug delivery device comprises subtracting a reference current value from a peak current value during an actuation cycle of the pump to determine a stroke current value.
2. 2 . The method of claim 1 , further comprising terminating the delivery of fluid through the fluid line when the delivery of fluid has been paused for a maximum delay period.
3. 3 . The method of claim 2 , wherein the maximum delay period is at least 30 seconds.
4. 4 . The method of claim 1 , wherein the predetermined condition comprises a predetermined pressure level within the fluid line.
5. 5 . The method of claim 1 , wherein the predetermined condition comprises a predetermined period of time.
6. 6 . The method of claim 1 , further comprising: initially delivering fluid through the fluid line via the pump at a first flow rate; and subsequently delivering fluid through the fluid line via the pump at a second flow rate, wherein the first flow rate is lower than the second flow rate.
7. 7 . The method of claim 6 , wherein the initial delivery of fluid through the fluid line via the pump at the first flow rate is configured to deliver 15-50 μL of fluid.
8. 8 . The method of claim 6 , wherein the initial delivery of fluid through the fluid line via the pump at the first flow rate comprises pausing the delivery of fluid for a predetermined delay period between delivery boluses.
9. 9 . The method of claim 6 , wherein the first flow rate corresponds to a maximum acceptable flow rate assuming a fully occluded condition.
10. 10 . The method of claim 9 , wherein the initial delivery of fluid through the fluid line via the pump at the first flow rate is configured to deliver a maximum of 20 μL of fluid.
11. 11 . The method of claim 1 , wherein at least one of b) through e) are performed using a microcontroller comprising at least one processor.
12. 12 . A drug delivery device comprising: a power source; a reservoir configured to receive a fluid; a fluid line in fluid communication with the reservoir; a pump configured to deliver the fluid from the reservoir to the fluid line; and a microcontroller comprising at least one processor programmed or configured to cause the device to: deliver fluid through the fluid line via the pump; determine a parameter indicative of pressure within the fluid line; determine whether the parameter indicative of pressure within the fluid line exceeds a pressure threshold level; pause the delivery of fluid through the fluid line until a predetermined condition is satisfied; and resume the delivery of the fluid through the fluid line after the predetermined condition is satisfied, wherein the parameter indicative of pressure within the fluid line is determined by measuring a current of the drug delivery device during actuation of the pump, and wherein the measuring of the current of the drug delivery device comprises subtracting a reference current value from a peak current value during an actuation cycle of the pump to determine a stroke current value.
13. 13 . The device of claim 12 , wherein the at least one processor is further programmed or configured to: initially deliver fluid through the fluid line via the pump at a first flow rate; and subsequently delivery fluid through the fluid line via the pump at a second flow rate, wherein the first flow rate is lower than the second flow rate.
14. 14 . The device of claim 13 , wherein the at least one processor is further programmed or configured to pause the delivery of fluid for a predetermined delay period between delivery boluses.
15. 15 . The device of claim 13 , wherein the first flow rate corresponds to a maximum acceptable flow rate assuming a fully occluded condition.
16. 16 . A computer program product for a method of pressure management for a drug delivery device comprising a microcontroller, a reservoir, a pump, a fluid line, and a power source, the computer program product comprising at least one non-transitory computer-readable medium including program instructions that, when executed by the microcontroller, cause the drug delivery device to: deliver fluid through the fluid line via the pump; determine a parameter indicative of pressure within the fluid line; determine whether the pressure within the fluid line exceeds a pressure threshold level; pause the delivery of fluid through the fluid line until a predetermined condition is satisfied; and resume the delivery of the fluid through the fluid line after the predetermined condition is satisfied, wherein the parameter indicative of pressure within the fluid line is determined by measuring a current of the drug delivery device during actuation of the pump, and wherein the measuring of the current of the drug delivery device comprises subtracting a reference current value from a peak current value during an actuation cycle of the pump to determine a stroke current value.
17. 17 . The computer program product of claim 16 , wherein the at least one non-transitory computer-readable medium further includes program instructions that, when executed by the microcontroller, cause the microcontroller to: initially deliver fluid through the fluid line via the pump at a first flow rate; and subsequently delivery fluid through the fluid line via the pump at a second flow rate, wherein the first flow rate is lower than the second flow rate.
18. 18 . The computer program product of claim 17 , wherein the at least one non-transitory computer-readable medium further includes program instructions that, when executed by the microcontroller, cause the microcontroller to pause the delivery of fluid for a predetermined delay period between delivery boluses.
19. 19 . The computer program product of claim 17 , wherein the first flow rate corresponds to a maximum acceptable flow rate assuming a fully occluded condition.
20. 20 . The computer program product of claim 16 , wherein the parameter indicative of pressure threshold level comprises a threshold, range, and/or rate of pressure increase.

Description

CROSS-REFERENCE TO RELATED APPLICATION The present application claims priority to U.S. Provisional Application Ser. No. 63/114,894, filed Nov. 17, 2020, entitled “Pressure Management Method for a Drug Delivery Device”, the entire disclosure of which is hereby incorporated by reference in its entirety. BACKGROUND OF THE INVENTION Field of the Invention The present disclosure relates to a method of pressure management for a drug delivery device. Description of Related Art Wearable medical devices, such as automatic injectors, have the benefit of providing therapy to the patient at a location remote from a clinical facility and/or while being worn discretely under the patient's clothing. The wearable medical device can be applied to the patient's skin and configured to automatically deliver a dose of a pharmaceutical composition within a predetermined time period after applying the wearable medical device to the patient's skin, such as after a 27 hour delay. After the device delivers the pharmaceutical composition to the patient, the patient may subsequently remove and dispose of the device. In certain circumstances, due to the medium the liquid is being injected, the flow of fluid leaving the device may be impaired, which can lead to increased pressure in the fluid line of the device. When the pressure rises above a certain threshold, the integrity of the fluid path may be compromised causing a leak within the device and a failure to deliver the full dose of medicament. A fluid leak within the device may also cause damage to the device and subsequent system failures as well as potential contamination concerns due to contact between the fluid and the device. Human subcutaneous tissue is composed of various cell types, extracellular matrix (ECM) constituents, microstructures, and macroscopic arrangement of cells and ECM. Those elements contribute to the mechanical properties of the tissue. The tissue may also include the lymphatic system, blood vessels, and has intrinsic fluid absorption and retention properties. These characteristics vary among individuals, location within the body, and over time may cause variable degrees of resistance to the infusion of fluids at the site of injection. When the resistance of the tissue is too high or the absorption rate is too low for a given delivery flow rate from the device, the pressure may build up and reach valves above the threshold where the fluid line and other components may be compromised. SUMMARY OF THE INVENTION In one aspect or embodiment, a method of pressure management for a drug delivery device a pump, a fluid line, and a power source, includes: delivering fluid through the fluid line via the pump; determining a parameter indicative of pressure within the fluid line; determining whether the parameter indicative of pressure within the fluid line exceeds a pressure threshold level; pausing the delivery of fluid through the fluid line until a predetermined condition is satisfied; and resuming the delivery of the fluid through the fluid line after the predetermined condition is satisfied. The method may be performed using a microcontroller comprising at least one processor. The method may include terminating the delivery of fluid through the fluid line when the delivery of fluid has been paused for a maximum delay period. The maximum delay period may be at least 30 seconds. In another configuration, the maximum delay period may be at least 4 minutes. The predetermined condition may be a predetermined pressure level within the fluid line. The predetermined condition may be a predetermined period of time. The pressure within the fluid line may be determined by measuring a parameter indicative of pressure, such as a current of the drug delivery device, during actuation of the pump. The measuring of the current of the drug delivery device may include subtracting a reference current value from a peak current value during an actuation cycle of the pump to determine a stroke current value. The predetermined condition may be an input from a sensor in the drug delivery device or an input from a user. The method may further include initially delivering fluid through the fluid line via the pump at a first flow rate, and subsequently delivering fluid through the fluid line via the pump at a second flow rate, where the first flow rate is lower than the second flow rate. The initial delivery of fluid through the fluid line via the pump at the first flow rate may be configured to deliver 15-50 μL of fluid. The initial delivery of fluid through the fluid line via the pump at the first flow rate may include pausing the delivery of fluid for a predetermined delay period between delivery boluses. The first flow rate may correspond to a maximum acceptable flow rate assuming a fully occluded condition. The initial delivery of fluid through the fluid line via the pump at the first flow rate may be configured to deliver a maximum of 20 μL of fluid. In a further aspect or embodiment, a