Systems and methods for pressure sensor-based efficient reservoir detection for
By using a pressure sensor-based system in the drug delivery device, the challenge of detecting the empty state of the flexible reservoir is solved, and successful monitoring of treatment and accurate control of dose is achieved.
Patent Information
- Application Number
- CN202380049607.6
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Priority Date
- 2022-07-07
- Filing Date
- 2023-06-27
- Publication Date
- 2025-03-04
AI Technical Summary
In drug delivery devices, it is challenging to detect the empty state of the flexible reservoir, especially in syringe-type reservoirs, where accurate detection of empty reservoirs is urgent to avoid inadequate doses and treatment disruptions.
采用基于压力传感器的系统,通过测量流体通路中的压力,利用微控制器确定贮存器中是否存在流体,并控制输出装置提供相应的指示。 该系统包括贮存器、泵和流体管线,压力传感器位于泵下游或上游,微控制器接收压力数据并进行比较以确定贮存器的状态。
Accurate detection of the empty state of the drug delivery device reservoir is achieved, ensuring the successful completion of treatment and the accuracy of dose, and avoiding the problems of treatment interruption and insufficient dose caused by premature storage emptying.
Smart Images

Figure CN119562838A_ABST
Abstract
Description
[0001] CROSS-REFERENCE TO RELATED APPLICATIONS
[0002] This application claims priority to U.S. patent application No. 17 / 859,643, filed on July 7, 2022, entitled “System and Method for Pressure Sensor Based Empty Reservoir Detection for a Drug Delivery Device,” the entire disclosure of which is incorporated herein by reference in its entirety.
[0003] BACKGROUND OF THE INVENTION
[0004] field
[0005] The present disclosure relates to devices and methods for pressure sensor based empty reservoir detection for drug delivery devices.
[0006] Description of Related Technology
[0007] The benefit of a wearable medical device, such as an auto-injector, 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 (such as after a 27-hour delay). After the device delivers the pharmaceutical composition to the patient, the patient can then remove and dispose of the device.
[0008] In the case of liquid injection or infusion, certain drugs may be prescribed for administration in a strictly controlled dosage regimen (e.g., a precise dose may be prescribed for delivery with controlled timing, etc.). Injection devices typically implement controlled flow rates and dosage regimens based on volumetric dosage, where the system applies a known volume displacement to the fluid being administered. Exemplary systems that implement volume-based dosage control are syringe pumps, oscillo-rotative pumps, systems with moving pistons, peristaltic pumps, and membrane and diaphragm pumps.
[0009] A subset of these pumps works on the basis of a "dosing chamber element" that is cyclically filled and emptied. A peculiarity of these systems is that the fluid path upstream of the pump may not be in direct communication with the path downstream of the pump, allowing different pressures to build up in these respective fluid paths.
[0010] The ability to detect when a device drug reservoir becomes empty may be desirable. This allows notification to the patient of successful completion of a therapeutic treatment. This also allows detection of possible failure modes or when the reservoir is emptied prematurely, which may result in an underdose and may negatively impact the ongoing therapeutic treatment. Precisely and accurately detecting an empty reservoir may be particularly challenging in devices with flexible reservoirs, whereas syringe-type reservoirs may more easily utilize linear motion of a syringe stop. Summary of the invention
[0011] Thus, improved systems, devices, products, apparatus and / or methods are provided for empty reservoir detection of drug delivery devices.
[0012] According to some non-limiting embodiments or aspects, a drug delivery device is provided, comprising: a fluid pathway, the fluid pathway comprising a reservoir, a pump located downstream of the reservoir, and a fluid line located downstream of the pump, wherein the reservoir is configured to receive a fluid, and wherein the pump is configured to deliver the fluid from the reservoir to the fluid line; a pressure sensor, the pressure sensor being configured to measure the pressure in the fluid pathway; and a microcontroller, the microcontroller being programmed and / or configured to: receive the pressure measured in the fluid pathway from the pressure sensor; determine whether the fluid is absent in the reservoir based on the pressure measured in the fluid pathway; and control an output device to provide an indication associated with determining whether the fluid is absent in the reservoir.
[0013] In some non-limiting embodiments or aspects, the pressure sensor is located downstream of the pump in the fluid pathway.
[0014] In some non-limiting embodiments or aspects, the pressure sensor is located upstream of the pump in the fluid pathway.
[0015] In some non-limiting embodiments or aspects, the microcontroller is programmed and / or configured to determine whether the fluid is absent from the reservoir by: comparing the pressure measured in the fluid pathway with a threshold pressure; and in response to the pressure measured in the fluid pathway satisfying the threshold pressure, determining that the fluid is absent from the reservoir.
[0016] In some non-limiting embodiments or aspects, the microcontroller is programmed and / or configured to determine whether the fluid is absent from the reservoir by: determining a rate of change associated with the pressure measured in the fluid pathway based on the pressure measured in the fluid pathway; comparing the rate of change associated with the pressure measured in the fluid pathway with a threshold rate of change; and determining that the fluid is absent from the reservoir in response to the rate of change associated with the pressure measured in the fluid pathway satisfying the threshold rate of change.
[0017] In some non-limiting embodiments or aspects, the pump includes a dosing chamber, and wherein the pump is configured to cyclically (i) pump the reservoir while the dosing chamber is in fluid communication with the reservoir but not in fluid communication with the fluid line and (ii) fluidly connect the dosing chamber with the fluid line.
[0018] In some non-limiting embodiments or aspects, the microcontroller is further programmed and / or configured to determine a baseline pressure based on the pressure measured in the fluid pathway prior to fluidly connecting the dose chamber with the fluid line, wherein the microcontroller is programmed and / or configured to determine whether the reservoir is empty based on the pressure measured in the fluid pathway and the baseline pressure.
[0019] In some non-limiting embodiments or aspects, the pressure sensor includes at least one of: an absolute pressure sensor, a differential pressure sensor, or any combination thereof.
[0020] According to some non-limiting embodiments or aspects, a method for pressure sensor-based empty reservoir detection for a drug delivery device is provided, the drug delivery device comprising a fluid pathway, the fluid pathway comprising a reservoir configured to receive a fluid, a pump located downstream of the reservoir, and a fluid line located downstream of the pump, the method comprising: utilizing the pump to deliver the fluid from the reservoir to the fluid line; utilizing the pressure sensor to measure the pressure in the fluid pathway; utilizing a microcontroller to receive the pressure measured in the fluid pathway; utilizing the microcontroller to determine whether the fluid is absent from the reservoir based on the pressure measured in the fluid pathway; and utilizing the microcontroller to control an output device to provide an indication associated with determining whether the fluid is absent from the reservoir.
[0021] In some non-limiting embodiments or aspects, the pressure sensor measures the pressure in the fluid pathway downstream of the pump.
[0022] In some non-limiting embodiments or aspects, the pressure sensor measures the fluid in the fluid passage upstream of the pump.
[0023] In some non-limiting embodiments or aspects, determining whether there is no fluid in the reservoir includes: comparing the pressure measured in the fluid pathway with a threshold pressure; and in response to the pressure measured in the fluid pathway satisfying the threshold pressure, determining that there is no fluid in the reservoir.
[0024] In some non-limiting embodiments or aspects, determining whether there is no fluid in the reservoir includes: determining a rate of change associated with the pressure measured in the fluid pathway based on the pressure measured in the fluid pathway; comparing the rate of change associated with the pressure measured in the fluid pathway with a threshold rate of change; and determining that there is no fluid in the reservoir in response to the rate of change associated with the pressure measured in the fluid pathway satisfying the threshold rate of change.
[0025] In some non-limiting embodiments or aspects, the pump includes a dosing chamber, and delivering the fluid from the reservoir to the fluid line includes cyclically (i) drawing the reservoir while the dosing chamber is in fluid communication with the reservoir but not in fluid communication with the fluid line and (ii) fluidly connecting the dosing chamber to the fluid line.
[0026] In some non-limiting embodiments or aspects, the method further comprises: determining, using the microcontroller, a baseline pressure based on the pressure measured in the fluid pathway before fluidly connecting the dose chamber with the fluid line, wherein determining whether the reservoir is empty is based on the pressure measured in the fluid pathway and the baseline pressure.
[0027] In some non-limiting embodiments or aspects, the pressure sensor includes at least one of: an absolute pressure sensor, a differential pressure sensor, or any combination thereof.
[0028] According to some non-limiting embodiments or aspects, a computer program product for pressure sensor-based empty reservoir detection for a drug delivery device is provided, the drug delivery device comprising a microcontroller, a pressure sensor, and a fluid pathway, the fluid pathway comprising a reservoir configured to receive a fluid, a pump located downstream of the reservoir, and a fluid line located downstream of the pump, the computer program product comprising at least one non-transitory computer-readable medium, the at least one non-transitory computer-readable medium comprising program instructions that, when executed by the microcontroller, cause the microcontroller to: control the pump to deliver the fluid from the reservoir to the fluid line; control the pressure sensor to measure the pressure in the fluid pathway; receive the pressure measured in the fluid pathway; determine whether the fluid is absent from the reservoir based on the pressure measured in the fluid pathway; and control an output device to provide an indication associated with determining whether the fluid is absent from the reservoir.
[0029] In some non-limiting embodiments or aspects, the microcontroller controls the pressure sensor to measure the pressure in the fluid pathway downstream of the pump.
[0030] In some non-limiting embodiments or aspects, the pump includes a dosing chamber, wherein the pump delivers the fluid from the reservoir to the fluid line by cyclically (i) drawing from the reservoir while the dosing chamber is in fluid communication with the reservoir but not in fluid communication with the fluid line and (ii) fluidly connecting the dosing chamber to the fluid line.
[0031] In some non-limiting embodiments or aspects, the microcontroller controls the pressure sensor to measure the pressure in the fluid passage upstream of the pump. BRIEF DESCRIPTION OF THE DRAWINGS
[0032] 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 in conjunction with the accompanying drawings.
[0033] Figure 1 is a perspective view of a drug delivery device according to one aspect or embodiment of the present application;
[0034] Figure 2 for Figure 1 A perspective view of a drug delivery device with a top cover removed;
[0035] Figure 3 for Figure 1 Schematic diagram of a drug delivery device;
[0036] Figure 4 A schematic diagram of a system for empty reservoir detection based on a pressure sensor according to one aspect or embodiment of the present application;
[0037] Figure 5 for Figure 1 Example pressure signature diagram of a drug delivery device;
[0038] Figure 6 for Figure 1 Another example pressure signature diagram of a drug delivery device;
[0039] Figure 7 for Figure 1 A graph of example pressure signatures and motor current signatures for a drug delivery device of FIG. 1 ; and
[0040] Figure 8 Flow chart of a process of pressure sensor-based empty reservoir detection for a drug delivery device according to one aspect or embodiment of the present application.
[0041] 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
[0042] Spatial or directional terms (such as "left", "right", "inner", "outer", "upper", and "lower", etc.) should not be considered limiting, as aspects or embodiments of the present disclosure may assume various alternative orientations.
[0043] 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".
[0044] 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 cover 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 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.
[0045] 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 slow, 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.
[0046] Reference again Figures 1 to 3In one aspect or embodiment, the power source 14 is a direct current (DC) power source that includes one or more batteries. The control electronics 18 include a microcontroller 24 that controls actuation of the drug delivery device 10, sensing electronics 26, a pump and valve controller 28, sensing electronics 30, and deployment electronics 32. The drug delivery device 10 includes a fluid subsystem that includes a reservoir 12, a volume sensor 34 for the reservoir 12, a reservoir fill port 36, and a metering system 38 that includes a pump and valve actuator 40 and a pump and valve mechanism 42. The fluid subsystem 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 occlusion sensor 44 includes a pressure sensor, such as described herein with respect to Figure 4 The pressure sensor 54 is described in more detail. In one aspect or embodiment, the insertion mechanism 16 is configured to move the cannula 48 from a retracted position completely within the drug delivery device 10 to an extended position in which the cannula 48 extends outside the drug delivery device 10. The drug delivery device 10 can operate in the same manner as discussed in U.S. Patent No. 10,449,292 to Pizzochero et al., which is incorporated herein by reference.
[0047] In one aspect or embodiment, the fluid pathway is formed by the reservoir 12, the pump and valve mechanism 42 located downstream of the reservoir 12, and the fluid line 50 located downstream of the pump and valve mechanism 42. For example, the reservoir 12 can be configured to receive a fluid, and the pump and valve mechanism 42 can be configured to deliver the fluid from the reservoir 12 to the fluid line 50.
[0048] refer to Figure 4In one aspect or embodiment, the pump and valve mechanism 42 includes a dosing chamber 52. The pump and valve mechanism 42 can be configured to cyclically (i) draw the reservoir 12 while the dosing chamber 52 is in fluid communication with the reservoir 12 but not in fluid communication with the fluid line 50 and (ii) fluidly connect the dosing chamber 52 with the fluid line 50 (e.g., while the dosing chamber 52 is not in fluid communication with the reservoir 12, etc.). For example, the pump and valve mechanism 42 can draw the reservoir 12 while the dosing chamber 52 is in fluid communication with the reservoir 12 but not in fluid communication with the fluid line 50 to fill the dosing chamber 52 with fluid from the reservoir 12, and the pump and valve mechanism 42 can connect the dosing chamber 52 with the fluid line 50 to empty the fluid in the dosing chamber 52 and deliver the fluid to the fluid line 50 (e.g., while the dosing chamber 52 is not in fluid communication with the reservoir 12, etc.). In this manner, fluid paths upstream of the pump and valve mechanism 42 (eg, upstream of the dosing chamber 52, etc.) may not be in direct fluid communication with fluid paths downstream of the pump and valve mechanism 42, thereby allowing different pressures to be established in these respective upstream and downstream fluid paths.
[0049] Still refer to Figure 4 , the drug delivery device 10 may include a pressure sensor 54. The pressure sensor 54 may be configured to measure the pressure in a fluid path formed by the reservoir 12, the pump and valve mechanism 42 located downstream of the reservoir 12, and the fluid line 50 located downstream of the pump and valve mechanism 42. The pressure sensor 54 may be located downstream of the pump and valve mechanism 42 in the fluid path and / or upstream of the pump and valve mechanism 42 in the fluid path. For example, the pressure sensor 54 may be configured to measure the pressure in the fluid path downstream of the pump and valve mechanism 42 (e.g., downstream of the dosing chamber 52, etc.) and / or the pressure in the fluid path upstream of the pump and valve mechanism 42 (e.g., upstream of the dosing chamber 52, etc.). The pressure sensor 54 may include at least one of the following: an absolute pressure sensor, a differential pressure (e.g., a gauge pressure) sensor, or any combination thereof. The pressure sensor 54 may be miniaturized, may have high resolution, may be cost-effective, and / or may be optimized for low power consumption.
[0050] The microcontroller 24 may be programmed and / or configured to: receive the pressure measured in the fluid pathway from the pressure sensor 54; determine whether there is no fluid in the reservoir 12 based on the pressure measured in the fluid pathway; and / or control an output device (e.g., a display, a light emitting diode (LED), a speaker, etc.) to provide an indication associated with determining whether there is no fluid in the reservoir 12. The output device may be included in and / or integrated with the drug delivery device 10, and / or the output device may be included in and / or integrated with an external device located outside the drug delivery device 10 and in communication (e.g., wireless and / or wireless communication, etc.) with the drug delivery device 10, such as a remote computing device and / or wireless controller (WC) 500 discussed in U.S. Pat. No. 10,449,292 to Pizzochero et al., which is incorporated herein by reference.
[0051] In this way, and also with reference to Figures 5 to 7 When the dosing chamber 52 of the pump and valve mechanism 42 creates a void volume after drawing out the empty reservoir 12 and becomes in fluid communication with a downstream fluid path (e.g., fluid line 50, etc.), the drug delivery device 10 may recognize a pressure drop as a sign of an empty reservoir 12. For example, vacuum pressure created in an upstream fluid path upstream of the dosing chamber 52 may create a recognizable pressure signature in a downstream fluid path downstream of the dosing chamber 52.
[0052] In one aspect or embodiment, the microcontroller 24 is programmed and / or configured to determine whether there is no liquid in the reservoir 12 by comparing the pressure measured in the fluid pathway to a threshold pressure, and in response to the pressure measured in the fluid pathway satisfying the threshold pressure, determining that there is no fluid in the reservoir 12. For example, the microcontroller 24 may compare the pressure drop achieved when the dosing chamber 52 of the pump and valve mechanism 42 is connected to a downstream fluid path (e.g., to the fluid line 50, etc.) to the threshold pressure, and in response to the pressure drop satisfying the threshold pressure, determine that there is no fluid in the reservoir 12.
[0053] In one aspect or embodiment, the microcontroller 24 is programmed and / or configured to determine whether there is no fluid in the reservoir 12 by: determining a rate of change associated with the pressure measured in the fluid pathway based on the pressure measured in the fluid pathway; comparing the rate of change associated with the pressure measured in the fluid pathway with a threshold rate of change; and in response to the rate of change associated with the pressure measured in the fluid pathway satisfying the threshold rate of change, determining that there is no fluid in the reservoir 12. For example, the microcontroller 24 may compare the rate of change associated with the pressure measured in the fluid pathway during the draw (e.g., rate of pressure increase, rate of pressure decrease, rate of rate of pressure increase, rate of rate of pressure decrease, etc.) with the threshold rate of change, and in response to the measured rate of change satisfying the threshold rate, determine that there is no fluid in the reservoir 12.
[0054] In one aspect or embodiment, the microcontroller 24 is further programmed and / or configured to: determine a baseline pressure based on a pressure measured in the fluid pathway before fluidly connecting the dosing chamber 52 to the fluid line 50; and determine whether the reservoir 12 is empty based on the pressure measured in the fluid pathway and the baseline pressure. For example, the pressure marker measured in the fluid pathway can be offset by a baseline pressure marker defined by a pressure value measured before connecting the dosing chamber 52 to the downstream fluid path.
[0055] In one aspect or embodiment, the indication associated with determining whether the reservoir 12 is empty of fluid includes a notification of successful completion of treatment or a notification of a failure mode and / or premature emptying of the reservoir. For example, the microcontroller 24 can be further programmed and / or configured to compare the time and / or pump cycles (e.g., using a clock and / or counter of the microcontroller 24, etc.) at which the reservoir 12 is determined to be empty with a threshold time and / or pump cycles, and based on this, determine that the treatment has been successfully completed or a failure mode has been detected or the reservoir has been emptied prematurely. As an example, in response to the time and / or pump cycles meeting the threshold time and / or pump cycles, the microcontroller 24 can determine that the treatment has been successfully completed. As an example, in response to the time and / or pump cycles failing to meet the threshold time and / or pump cycles, the microcontroller 24 can determine that the drug delivery device 10 is in a failure mode and / or the reservoir 12 has been emptied prematurely, which may result in insufficient dosage and / or may negatively affect the ongoing therapeutic treatment.
[0056] refer to Figure 8In one aspect or embodiment, a process 800 for pressure sensor-based empty reservoir detection for a drug delivery device 10 includes: receiving a fluid in a reservoir 12 (step 802); determining, using a microcontroller 24, a baseline pressure based on a pressure measured in a fluid pathway (e.g., by a pressure sensor 54, etc.) (step 804); delivering the fluid from the reservoir 12 to the fluid line 50 using a pump and valve mechanism 42 (step 806); measuring the pressure in the fluid pathway using the pressure sensor 54 (step 808); receiving, using the microcontroller 24, the pressure measured in the fluid pathway (step 810); determining, using the microcontroller 24, whether there is no fluid in the reservoir 12 based on the pressure measured in the fluid pathway (step 812); and controlling, using the microcontroller 24, an output device to provide an indication associated with determining whether there is no fluid in the reservoir 12 (step 814).
[0057] Thus, non-limiting embodiments or aspects of the present application may provide a drug delivery device that has low manufacturing costs, extremely low power consumption, is compact in size, and / or has low computing power requirements, which may utilize hardware that may be present in an extraction system and / or may be used with flexible reservoir bags, rigid containers, and / or syringe-like containers.
[0058] Although for the purpose of illustration, various aspects or embodiments have been described in detail based on what are currently considered to be the most practical and preferred embodiments, it should be understood that such details are only for this purpose, and the various aspects or embodiments of the present disclosure are not limited to the disclosed embodiments, but on the contrary, the various aspects or embodiments of the present disclosure are 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 disclosure 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: a fluid pathway comprising a reservoir, a pump downstream of the reservoir, and a fluid line downstream of the pump, wherein the reservoir is configured to receive a fluid, and wherein the pump is configured to deliver the fluid from the reservoir to the fluid line; a pressure sensor configured to measure pressure in the fluid passage; and A microcontroller, the microcontroller being programmed and / or configured to: receiving the pressure measured in the fluid passage from the pressure sensor; determining whether the reservoir is empty of the fluid based on the pressure measured in the fluid pathway; and An output device is controlled to provide an indication associated with determining whether the reservoir is empty of the fluid.
2. The drug delivery device according to claim 1, wherein: The pressure sensor is located in the fluid pathway downstream of the pump.
3. The drug delivery device according to claim 1, wherein: The pressure sensor is located in the fluid pathway upstream of the pump.
4. The drug delivery device according to claim 1, wherein: The microcontroller is programmed and / or configured to determine whether the fluid is absent from the reservoir by: comparing the pressure measured in the fluid passage to a threshold pressure; as well as In response to the pressure measured in the fluid pathway satisfying the threshold pressure, it is determined that the reservoir is free of the fluid.
5. The drug delivery device according to claim 1, wherein: The microcontroller is programmed and / or configured to determine whether the fluid is absent from the reservoir by: determining, based on the pressure measured in the fluid pathway, a rate of change associated with the pressure measured in the fluid pathway; comparing the rate of change associated with the pressure measured in the fluid passageway to a threshold rate of change; as well as In response to the rate of change associated with the pressure measured in the fluid pathway satisfying the threshold rate of change, it is determined that there is no fluid in the reservoir.
6. The drug delivery device according to claim 1, wherein: The pump includes a dosing chamber, and wherein the pump is configured to cyclically: (i) draw from the reservoir while the dosing chamber is in fluid communication with the reservoir but not in fluid communication with the fluid line and (ii) fluidly connect the dosing chamber with the fluid line.
7. The drug delivery device according to claim 6, wherein: The microcontroller is further programmed and / or configured to: Prior to fluidly connecting the dose chamber with the fluid line, a baseline pressure is determined based on the pressure measured in the fluid pathway, wherein the microcontroller is programmed and / or configured to determine whether the reservoir is empty based on the pressure measured in the fluid pathway and the baseline pressure.
8. The drug delivery device according to claim 1, wherein: The pressure sensor includes at least one of the following: an absolute pressure sensor, a differential pressure sensor, or any combination thereof.
9. A method for pressure sensor-based empty reservoir detection for a drug delivery device, the drug delivery device comprising a fluid pathway, the fluid pathway comprising a reservoir configured to receive a fluid, a pump located downstream of the reservoir, and a fluid line located downstream of the pump, the method comprising: delivering the fluid from the reservoir to the fluid line using the pump; Measuring the pressure in the fluid passage using a pressure sensor; receiving, with a microcontroller, the pressure measured in the fluid passage; determining, using the microcontroller, whether the reservoir is empty of the fluid based on the pressure measured in the fluid pathway; as well as Using the microcontroller, an output device is controlled to provide an indication associated with determining whether the reservoir is empty of the fluid.
10. The method according to claim 9, wherein: The pressure sensor measures the pressure in the fluid passage downstream of the pump.
11. The method according to claim 9, wherein: The pressure sensor measures the fluid in the fluid passage upstream of the pump.
12. The method according to claim 9, wherein: Determining whether the reservoir is empty of fluid comprises: comparing the pressure measured in the fluid passage to a threshold pressure; and In response to the pressure measured in the fluid pathway satisfying the threshold pressure, it is determined that the reservoir is free of the fluid.
13. The method according to claim 9, wherein: Determining whether the reservoir is empty of fluid comprises: determining, based on the pressure measured in the fluid pathway, a rate of change associated with the pressure measured in the fluid pathway; comparing the rate of change associated with the pressure measured in the fluid pathway to a threshold rate of change; and In response to the rate of change associated with the pressure measured in the fluid pathway satisfying the threshold rate of change, it is determined that there is no fluid in the reservoir.
14. The method according to claim 9, wherein: The pump comprises a dosing chamber, and wherein delivering the fluid from the reservoir to the fluid line comprises: Cyclicly: (i) drawing the reservoir while the dosing chamber is in fluid communication with the reservoir but not in fluid communication with the fluid line and (ii) fluidly connecting the dosing chamber with the fluid line.
15. The method according to claim 14, further comprising: Prior to fluidly connecting the dosing chamber with the fluid line, determining, with the microcontroller, a baseline pressure based on the pressure measured in the fluid pathway, wherein determining whether the reservoir is empty is based on the pressure measured in the fluid pathway and the baseline pressure.
16. The method according to claim 9, wherein: The pressure sensor includes at least one of the following: an absolute pressure sensor, a differential pressure sensor, or any combination thereof.
17. A computer program product for pressure sensor based empty reservoir detection for a drug delivery device, the drug delivery device comprising a microcontroller, a pressure sensor, and a fluid pathway, the fluid pathway comprising a reservoir configured to receive a fluid, a pump located downstream of the reservoir, and a fluid line located downstream of the pump, the computer program product comprising at least one non-transitory computer readable medium, the at least one non-transitory computer readable medium comprising program instructions that, when executed by the microcontroller, cause the microcontroller to: controlling the pump to deliver the fluid from the reservoir to the fluid line; controlling the pressure sensor to measure the pressure in the fluid passage; receiving the pressure measured in the fluid passage; determining whether the reservoir is empty of the fluid based on the pressure measured in the fluid pathway; and An output device is controlled to provide an indication associated with determining whether the reservoir is empty of the fluid.
18. The computer program product of claim 17, wherein: The microcontroller controls the pressure sensor to measure the pressure in the fluid passage downstream of the pump.
19. The computer program product of claim 18, wherein: The pump comprises a dosing chamber, wherein the pump delivers the fluid from the reservoir to the fluid line by: Cyclicly: (i) drawing the reservoir while the dosing chamber is in fluid communication with the reservoir but not in fluid communication with the fluid line and (ii) fluidly connecting the dosing chamber with the fluid line.
20. The computer program product of claim 17, wherein: The microcontroller controls the pressure sensor to measure the pressure in the fluid passage upstream of the pump.
Citation Information
Patent Citations
Plate with integral fluid path channels
US10449292B2