System and method for detecting pre-charge of fluid path of drug delivery device

Abstract

A drug delivery device comprises: a housing; a reservoir positioned within the housing and configured to receive a fluid; a fluid line in fluid communication with the reservoir; a delivery subsystem configured to deliver fluid from the reservoir to the fluid line; an insertion mechanism comprising a cannula in fluid communication with the fluid line, where the insertion mechanism is configured to move the cannula from a retracted position in which the cannula is positioned within the housing to an extended position in which at least a portion of the cannula is positioned outside the housing; a sensor configured to detect when air is present within the fluid line; and control electronics configured to actuate the insertion mechanism based on a signal from the sensor.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. patent application No. 17 / 860,525, filed on July 8, 2022, entitled “System and Method for Detecting Priming of a Fluid Path of a Drug Delivery Device,” the entire disclosure of which is incorporated herein by reference in its entirety.

[0003] BACKGROUND OF THE INVENTION

[0004] Field of the Invention

[0005] The present disclosure relates to systems and methods for detecting priming of a fluid path of a drug delivery device.

[0006] Description of Related Technology

[0007] The benefit of a wearable medical device, such as an auto-injector or infusion device, is to provide treatment to a patient at a location remote from a clinical facility and / or while being worn separately 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 the wearable medical device is applied to the patient's skin. After the device delivers the pharmaceutical composition to the patient, the patient can then remove and dispose of the device.

[0008] In order to achieve repeatable and accurate performance (such as accurate dosing) of a wearable medical device, the device must be primed to remove air from the fluid path. The device can be primed manually or by the patient or a medical technician as part of a series of device startup steps. Summary of the invention

[0009] In one aspect or embodiment, a drug delivery device includes: a housing; a reservoir positioned within the housing and configured to receive a fluid; a fluid line connected to the reservoir fluid; a delivery subsystem configured to deliver fluid from the reservoir to the fluid line; an insertion mechanism including a cannula connected to the fluid line fluid, wherein the insertion mechanism is configured to move the cannula from a retracted position, in which the cannula is positioned within the housing, to an extended position, in which at least a portion of the cannula is positioned outside the housing; a sensor configured to detect when air is present within the fluid line; and control electronics configured to actuate the insertion mechanism based on a signal from the sensor.

[0010] The drug delivery device may include a hydrophobic membrane in fluid communication with the fluid line, wherein the hydrophobic membrane is configured to allow air to be discharged from the fluid line. The sensor may be positioned upstream of the hydrophobic membrane. The sensor may be positioned downstream of the hydrophobic membrane. The control electronics may include a microcontroller. The cannula may include a needle and a catheter, wherein the insertion mechanism is configured to place the catheter into the patient via the needle. The sensor may include a pressure sensor. The sensor may include a fluid detection sensor. The sensor may include an electronic switch having an open position when in fluid communication with air and a closed position when in fluid communication with a liquid. The insertion mechanism may include a solenoid actuator. The insertion mechanism may include a piezoelectric actuator. The drug delivery device may also include a power supply.

[0011] In another aspect or embodiment, a method of using a drug delivery device according to any of the above aspects or embodiments includes: actuating the drug delivery device; delivering fluid from the reservoir to the fluid line; determining whether air is present in the fluid line; sending a signal to the control electronic device when the air is removed from the fluid line to a predetermined acceptable limit; and automatically actuating the insertion mechanism to move the cannula from the retracted position to the extended position.

[0012] In another aspect or embodiment, a drug delivery device includes: a housing; a fluid line; a delivery subsystem configured to deliver fluid to a patient via the fluid line; and a sensor configured to detect when air is present in the fluid line.

[0013] The drug delivery device may also include a reservoir positioned within the housing and configured to receive a fluid, wherein the fluid line is in fluid communication with the reservoir, and wherein the delivery subsystem is configured to deliver fluid from the reservoir to the fluid line. The drug delivery device may also include an insertion mechanism comprising a cannula in fluid communication with the fluid line, wherein the insertion mechanism is configured to move the cannula from a retracted position to an extended position, wherein the cannula is positioned within the housing, and wherein at least a portion of the cannula is positioned outside the housing. The drug delivery device may also include control electronics configured to actuate the insertion mechanism based on a signal from the sensor. The sensor may be near the distal end of the fluid line. The sensor may be near the proximal end of the fluid line. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] The above and other features and advantages of the present disclosure and the manner of achieving them will become more apparent, and the present disclosure itself will be better understood by referring to the following description of embodiments of the present disclosure taken in conjunction with the accompanying drawings.

[0015] Figure 1 is a perspective view of a drug delivery device according to one aspect or embodiment of the present application.

[0016] Figure 2 yes Figure 1 A perspective view of a drug delivery device with a top cover removed.

[0017] Figure 3 yes Figure 1 Schematic diagram of a drug delivery device.

[0018] Figure 4 is a schematic diagram of a system for prefilling a fluid path of a drug delivery device according to one aspect or embodiment of the present application.

[0019] Figure 5 is a schematic diagram of a system for prefilling a fluid path of a drug delivery device according to another aspect or embodiment of the present application.

[0020] Corresponding reference numerals indicate corresponding parts throughout the several views.The exemplifications set out herein illustrate exemplary embodiments of the disclosure, and such exemplifications should not be construed as limiting the scope of the disclosure in any way. DETAILED DESCRIPTION

[0021] Spatial or directional terms (such as "left", "right", "inner", "outer", "upper", and "lower", etc.) are not to be considered limiting as the invention can assume various alternative orientations.

[0022] All numbers used in the specification and claims are to be understood as being modified in all cases by the term "about". "About" means a range of plus or minus ten percent of the value recorded. As used in the specification and claims, the singular forms "a", "an", and "the" include plural references unless the context clearly indicates otherwise. The terms "first", "second", etc. are not intended to refer to any particular order or sequence, but rather to different conditions, characteristics, or elements. "At least" means "greater than or equal to".

[0023] refer to Figures 1 to 3 , the drug delivery device 10 includes a reservoir 12, a power source 14, an insertion mechanism 16, control electronics 18, a cap 20, and a base 22. In one aspect or embodiment, the drug delivery device 10 is a wearable automatic injector, such as an insulin or bone marrow stimulant delivery device. The drug delivery device 10 can be mounted on the patient's skin and can be triggered to inject the drug composition from the reservoir 12 into the patient's body. The drug delivery device 10 can be pre-filled with the drug composition, or the drug delivery device 10 can be filled with the drug composition by the patient or a medical professional before use.

[0024] The drug delivery device 10 is configured to deliver a dose of a drug composition (e.g., any desired medicament) to a patient via subcutaneous injection at a controlled injection rate. An exemplary duration of delivery achieved by the drug delivery device 10 may be in the range of about 5 minutes to about 60 minutes, but is not limited to this exemplary range. An exemplary volume of the drug composition delivered by the drug delivery device 10 may be in the range of about 0.1 milliliters to about 10 milliliters, but is not limited to this exemplary range. The volume of the drug composition delivered to the patient may be adjusted.

[0025] Reference again Figures 1 to 3In one aspect or embodiment, the power source 14 is a direct current (DC) power source including one or more batteries. The control electronics 18 includes a microcontroller 24 that controls actuation of the drug delivery device 10, a sensing electronics 26, a pump and valve controller 28, a sensing electronics 30, and a deployment electronics 32. The drug delivery device 10 includes a fluidics sub-system that includes a reservoir 12, a volume sensor 34 for the reservoir 12, a reservoir fill port 36, and a delivery or metering sub-system 38 that includes a pump and valve actuator 40 and a pump and valve mechanism 42. The fluidics sub-system may also include an occlusion sensor 44, a deployment actuator 46, a cannula 48 for insertion into the patient's skin, and a fluid line 50 in fluid communication with the reservoir 12 and the cannula 48. In one aspect or embodiment, the insertion mechanism 16 is configured to move the cannula 48 from a retracted position fully positioned within the device 10 to an extended position in which the cannula 48 extends outside the device 10. The drug delivery device 10 may operate in the same manner as discussed in US Pat. No. 10,449,292 to Pizzochero et al., which is incorporated herein by reference.

[0026] refer to Figure 4 and Figure 5 In one aspect or embodiment of the present application, the drug delivery device 10 includes a sensor 60 configured to detect when air is present within the fluid line 50, wherein the control electronics 18 is configured to actuate the insertion mechanism 16 based on a signal from the sensor 60. In some aspects or embodiments, the sensor 60 enables automatic priming of the device 10 and subsequent automatic insertion of the cannula 48 into the subcutaneous tissue, and requires only one interactive step by the patient or medical technician.

[0027] Reference again Figure 4 and Figure 5 In one aspect or embodiment, the drug delivery device 10 includes a hydrophobic membrane 62 in fluid communication with the fluid line 50, wherein the hydrophobic membrane 62 is configured to allow air to escape from the fluid line 50. Figure 4 and Figure 5As shown, the sensor 60 can be positioned upstream of the hydrophobic membrane 62, or can be positioned downstream of the hydrophobic membrane 62. The sensor 60 can be positioned closer to the delivery subsystem 38 than to the insertion mechanism 16, or can be positioned closer to the insertion mechanism 16 than to the delivery subsystem 38. The sensor 60 can be positioned closer to the distal end of the fluid line 50 than to the proximal end of the fluid line 50, or can be positioned closer to the proximal end of the fluid line 50 than to the distal end of the fluid line 50. As described above, the control electronics 18 can include a microcontroller 24, but other processors and arrangements can be used. The cannula 48 can include a needle and / or a catheter (not shown), wherein the insertion mechanism 16 is configured to place the catheter into the patient via the needle, and then retract the needle, thereby leaving the catheter in the patient. The catheter can be a soft catheter.

[0028] refer to Figure 4 In one aspect or embodiment, the sensor 60 includes a pressure sensor 70. Air is less viscous than water and other liquids, and due to this difference in properties, air in the fluid line 50 can be detected via the pressure sensor 70 when all or substantially all of the air in the fluid line 50 has been expelled. When air is no longer detected or is at a predetermined acceptable limit, the pressure sensor 70 is configured to send a signal to the control electronics 18 and / or the insertion mechanism 16 to activate the insertion mechanism. The sensor 60 can also be or also include a fluid detection sensor, such as an optical or capacitive fluid sensor.

[0029] refer to Figure 5 In one aspect or embodiment, the sensor 60 includes an electronic switch 80 having an open position when in communication with an air fluid and a closed position when in communication with a liquid fluid. The electronic switch 80 is configured to be closed by a conductive fluid, such as a liquid medicament within the reservoir 12, which is delivered to the fluid line 50 and thereby contacts the electronic switch 80. The electronic switch 80 can be positioned in a channel 82 that is positioned away from the fluid line 50, although other suitable arrangements can also be used.

[0030] In some aspects or embodiments, the insertion mechanism 16 includes a solenoid actuator or a piezoelectric actuator (not shown). In addition, in some aspects or embodiments, the electronic signal from the sensor 60 is sent via a power cable passing through tubing of the infusion set or through a flexible printed circuit board (PCB).

[0031] In one aspect or embodiment, a method of using the drug delivery device 10 includes: actuating the drug delivery device 10; delivering fluid from the reservoir 12 to the fluid line 50; determining whether air is present within the fluid line 50; sending a signal to the control electronics 18 when air is removed from the fluid line 50; and automatically actuating the insertion mechanism 16 to move the cannula 48 from a retracted position to an extended position.

[0032] Although for the purpose of illustration, the present invention has been described in detail based on what is currently considered to be the most practical and preferred embodiments, it should be understood that such details are only for this purpose, and the present invention is not limited to the disclosed embodiments, but on the contrary, the present invention is intended to cover modifications and equivalent arrangements within the spirit and scope of the appended claims. For example, it should be understood that the present invention contemplates that, to the extent possible, one or more features of any embodiment can be combined with one or more features of any other embodiment.

Claims

1. A drug delivery device, comprising: case; a reservoir positioned within the housing and configured to receive a fluid; a fluid line in fluid communication with the reservoir; a delivery subsystem configured to deliver fluid from the reservoir to the fluid line; an insertion mechanism including a cannula in fluid communication with the fluid line, the insertion mechanism configured to move the cannula from a retracted position in which the cannula is positioned within the housing to an extended position in which at least a portion of the cannula is positioned outside of the housing; a sensor configured to detect when air is present within the fluid line; as well as Control electronics configured to actuate the insertion mechanism based on the signal from the sensor. 2 . The drug delivery device of claim 1 , further comprising a hydrophobic membrane in fluid communication with the fluid line, the hydrophobic membrane being configured to allow air to escape from the fluid line.

3. The drug delivery device according to claim 2, wherein: The sensor is positioned upstream of the hydrophobic membrane.

4. The drug delivery device according to claim 2, wherein: The sensor is positioned downstream of the hydrophobic membrane.

5. The drug delivery device according to any one of claims 1 to 4, wherein: The control electronics include a microcontroller.

6. The drug delivery device according to any one of claims 1 to 5, wherein: The cannula includes a needle and a catheter, and the insertion mechanism is configured to place the catheter into the patient's body via the needle.

7. The drug delivery device according to any one of claims 1 to 6, wherein: The sensor comprises a pressure sensor.

8. The drug delivery device according to any one of claims 1 to 6, wherein: The presence of air is determined by evaluating the pressure drop between the pump and the cannula when fluid is pumped in the fluid line and comparing the value to a threshold value.

9. The drug delivery device according to any one of claims 1 to 6, wherein: The presence of air is determined by evaluating the pressure drop when fluid is pumped in the cannula and comparing the value to a threshold value.

10. The drug delivery device according to any one of claims 1 to 6, wherein: The sensor includes a fluid detection sensor.

11. The drug delivery device according to any one of claims 1 to 6, wherein: The sensor includes an electronic switch having an open position when in fluid communication with air and a closed position when in fluid communication with liquid.

12. The drug delivery device according to any one of claims 1 to 11, wherein: The insertion mechanism includes a solenoid actuator.

13. The drug delivery device according to any one of claims 1 to 12, wherein: The insertion mechanism includes a piezoelectric actuator.

14. A drug delivery device according to any one of claims 1 to 13, further comprising a power source.

15. A method of using a drug delivery device according to any one of claims 1 to 14, the method comprising: actuating the drug delivery device; transferring fluid from the reservoir to the fluid line; determining whether air is present in the fluid line; sending a signal to the control electronics when air is removed from the fluid line to a predetermined acceptable limit; as well as The insertion mechanism is automatically actuated to move the cannula from the retracted position to the extended position.

16. A drug delivery device comprising: case; Fluid pipelines; a delivery subsystem configured to deliver fluid to a patient via the fluid line; as well as A sensor is configured to detect when air is present in the fluid line.

17. The drug delivery device of claim 16, further comprising a reservoir positioned within the housing and configured to receive a fluid, wherein: The fluid line is in fluid communication with the reservoir, and wherein the delivery subsystem is configured to deliver fluid from the reservoir to the fluid line.

18. The drug delivery device of claim 17, further comprising an insertion mechanism comprising a cannula in fluid communication with the fluid line, the insertion mechanism being configured to move the cannula from a retracted position, wherein the cannula is positioned within the housing, to an extended position, wherein at least a portion of the cannula is positioned outside the housing.

19. The drug delivery device of claim 17, further comprising control electronics configured to actuate an insertion mechanism based on a signal from the sensor.

20. The drug delivery device of claim 13, wherein: The sensor is proximate the distal end of the fluid line.

21. The drug delivery device of claim 13, wherein: The sensor is proximate the proximal end of the fluid line.

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