Non-invasive medical device efficiency and fault detection system and method of use - Patents.com

Abstract

A medical device efficiency detection method and system including a photoplethysmography (PPG) sensor device, a processor, a memory, and machine readable instructions that can cause the system to receive notifications at the PPG device from the medical device upon delivery of a therapeutic treatment, use the PPG device to search for a user's signal response based on the notifications within a predetermined time period to generate a response signal indicative of delivery of the therapeutic treatment, and send an alert if a response signal indicating failure to detect sufficient delivery of the therapeutic treatment is not generated within the predetermined time period. The instructions can cause the system to send an alert if a signal measurement from the PPG device at an infusion site is not within a sufficient signal range to indicate that the infusion site is insufficient for delivery of the therapeutic treatment by the medical device.

Description

[Technical field]

[0001] The present specification relates generally to a non-invasive medical device efficiency detection system and method of use, and more particularly to a non-invasive medical device efficiency and failure detection system and method of use for determining insulin failure detection, insulin site sufficiency, or a combination thereof using a closed loop connection device. [Background technology]

[0002] A medical device may be used to administer a therapy to treat a disease, such as delivering insulin to a diabetic user via insulin administration. Sometimes the medical device may contain an obstruction, such as a blockage, that prevents the delivery of insulin, but may not be detected. The medical device may still deliver a therapy at a site where an optimal amount of insulin is not administered.

[0003] Therefore, there is a need for alternative systems that efficiently deliver therapy to treat a user via medical device systems and methods of using such systems. Summary of the Invention

[0004] In one embodiment, a medical device efficacy detection system may include a photoplethysmography (PPG) sensor device, a medical device configured to administer a therapeutic treatment, a processor communicatively coupled to the PPG sensor device and the medical device, a memory communicatively coupled to the processor, and machine-readable instructions stored in the memory, which when executed by the processor, cause the medical device efficacy detection system to at least: communicatively connect the PPG sensor device and the medical device; deliver a therapeutic treatment to a user at an injection site via the medical device; receive a notification at the PPG sensor device from the medical device upon delivery of the therapeutic treatment; and use the PPG sensor device to measure a signal response of the user based on the notification within a predetermined period of time. search generating a response signal indicative of therapeutic treatment delivery; and Response If a response signal is not generated within a predetermined period of time, Indicates failure to detect adequate therapeutic treatment delivery Sending a warning.

[0005] In another embodiment, a medical device efficacy detection system may include a photoplethysmography (PPG) sensor device, a medical device configured to administer a therapeutic treatment, a processor communicatively coupled to the PPG sensor device and the medical device, a memory communicatively coupled to the processor, and machine-readable instructions stored in the memory, which when executed by the processor, cause the medical device efficacy detection system to at least: communicatively connect the PPG sensor device and the medical device, deliver the therapeutic treatment to a user at an infusion site via the medical device, receive a notification at the PPG sensor device from the medical device upon delivery of the therapeutic treatment, and use the PPG sensor device to generate a response signal indicative of delivery of the therapeutic treatment based on the notification within a predetermined period of time. search To do, and Location if no response signal is generated within the predetermined period of time, if a response signal is generated after a delay period within the predetermined period of time, if the response signal generated within the predetermined period of time is less than a threshold value, or any combination thereof; Indicates failure to detect adequate therapeutic treatment delivery Sending a warning.

[0006] In yet another embodiment, a medical device efficacy detection system may include a photoplethysmography (PPG) sensor device, a processor communicatively coupled to the PPG sensor device, a memory communicatively coupled to the processor, and machine-readable instructions stored in the memory that, when executed by the processor, may cause the medical device efficacy detection system to at least position the PPG sensor device over an infusion site of a user where the medical device will administer a therapeutic treatment, generate signal measurements from the PPG sensor device relating to tissue and vasculature underlying the infusion site, determine whether the signal measurements are within a sufficient signal range such that the infusion site is sufficient for delivery of the therapeutic treatment by the medical device, and send an alert if the signal measurements are not within a sufficient signal range to indicate that the infusion site is insufficient for delivery of the therapeutic treatment by the medical device.

[0007] These and additional features provided by the embodiments described herein will be more fully understood in consideration of the following detailed description, taken in conjunction with the drawings. [Brief description of the drawings]

[0008] The embodiments set forth in the drawings are illustrative and exemplary in nature and are not intended to limit the subject matter defined by the claims. The following detailed description of exemplary embodiments can be understood when read in conjunction with the following drawings, in which like structure is indicated with like reference numerals and in which:

[0009] [Figure 1] 1 illustrates a schematic diagram of a medical device efficiency detection system including a photoplethysmography (PPG) sensor device and an insulin delivery device for delivering insulin to a user at an injection site, according to one or more embodiments shown and described herein. [Diagram 2] 2A-2C are schematic diagrams illustrating measured physiological responses to the presence of insulin delivered by the insulin delivery device of FIG. 1 as detected by a PPG sensor device at different wavelengths. [Diagram 3] 2A-2C illustrate schematic diagrams of measured physiological responses detected by the PPG sensor device of FIG. 1 at different wavelengths when no insulin is being delivered. [Figure 4] FIG. 1 is a schematic diagram illustrating a PPG sensor device signal corresponding to underlying tissue and vasculature, according to one or more embodiments shown and described herein. [Diagram 5] 2 illustrates a schematic diagram of a system for implementing a computer and software-based method for utilizing the medical device efficiency detection system of FIG. 1 according to one or more embodiments shown and described herein. [Figure 6] 6 is a flowchart of a process for using the system of FIGS. 1 and 5 in accordance with one or more embodiments shown and described herein. [Figure 7] 6 is a flowchart of another process for using the system of FIGS. 1 and 5 in accordance with one or more embodiments shown and described herein. [Figure 8] 6 is a flowchart of yet another process for using the system of FIGS. 1 and 5 in accordance with one or more embodiments shown and described herein. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0010] With general reference to the figures, embodiments of the present disclosure relate to a medical device efficiency detection system for detecting failures (such as delivery device blockage) or insufficient or ineffective treatment delivery, and methods of using such closed-loop systems, for example, to prevent potential hyperglycemic conditions in diabetic users. A closed-loop system may refer to a system including a continuous blood glucose monitor and an insulin delivery device, such as an insulin pump, to automatically regulate a user's insulin with minimal user interaction to function as an artificial pancreas. An open-loop system may refer to a system that combines an external insulin pump with real-time continuous blood glucose monitoring via a subcutaneous sensor that transmits blood glucose readings to the external insulin pump. It is within the scope of the present disclosure that the systems described herein may be utilized with closed-loop and / or open-loop systems for diabetes management. Reference will now be made in detail to embodiments of a medical device efficiency detection system, examples of which are illustrated in the accompanying drawings. Wherever possible, the same reference numerals are used throughout the drawings to refer to the same or similar parts. Various embodiments of a medical device efficiency detection system are described in further detail herein with particular reference to the accompanying drawings.

[0011] Referring to FIG. 1, a medical device efficacy detection system 100 is shown including a photoplethysmography (PPG) sensor device 102 and a medical device 104 for delivering a treatment therapy to a user 110 at an infusion site 108. In one embodiment, the medical device 104 may be an insulin delivery device and the treatment therapy may be administration of insulin. The insulin delivery device may include and be coupled to a cradle 106 attached to the user 110 at the infusion site 108. The PPG sensor device 102 may be a wearable device separate from the medical device 104 and may be configured to be placed in an area on the user 110 detached from the infusion site 108 and the medical device 104. The PPG sensor device 102 may be a wristband, ring, finger clip, adhesive patch, toe clip, earbud-type device, earring, or forehead band, or other suitable wearable device. Alternatively, the PPG sensor device 102 may be a mobile smart device. The camera and flash of the mobile smart device may be configured to function as the photodiode and light source of the PPG sensor device 102, respectively.

[0012] In other embodiments, the PPG sensor device 102 may be integrated with a medical device. As a non-limiting example, the PPG sensor device 102 may be incorporated into a medical device 104, which may be an insulin pump adhered to the skin of the user 110. In the case of a patch pump, the PPG sensor device 102 may be integrated into a cradle 106 set against the body of the user 110 at the infusion site 108. Alternatively, the PPG sensor device 102 may be placed in a medical device 104, such as an infusion set. In embodiments, the PPG sensor device 102 may communicate via a communicative coupling with a medical device 104 associated with an insulin delivery device, such as an insulin pump, an insulin pen, an insulin inhaler, or a dedicated controller for the insulin delivery device. When blood glucose information is monitored by the medical device 104 as a blood glucose monitor for insulin disorder detection, the PPG sensor device 102 may also be directly or indirectly connected and communicatively coupled to the blood glucose monitor.

[0013] In various embodiments, the medical device efficiency detection system 100 may operate the PPG sensor device 102 to use the PPG signal to assist in efficient insulin administration for diabetic patients. The medical device efficiency detection system 100 may determine when insulin is delivered via the medical device 104 (such as via an insulin pump, insulin pen, or insulin inhaler) and may use the PPG sensor device 102 to detect the user's physiological response to the presence of delivered insulin upon notification of delivery by the medical device 104. The PPG sensor device 102 may be used to determine if and when insulin is being absorbed by the body due to the physiological response. When a user administers insulin, if a physiological response is not measured, the user may be alerted before a potentially dangerous situation occurs to prevent a potential hyperglycemic condition.

[0014] The medical device 104 may be configured to administer a therapeutic treatment, such as insulin delivery by insulin administration to the user 110. Such insulin administration may be a prescribed method for the user 110 to manage blood glucose for a diabetic patient. Insulin may be administered to the user via several types of medical device 104 forms, such as insulin pumps, insulin pens, inhaled insulin, and / or traditional shots. Such forms of medical device 104 may have blockage / obstruction issues that may reduce the efficiency of insulin delivery by the medical device 104 to the user 110. For example, a cannula associated with the medical device 104 for delivering insulin to the user 110 may become blocked such that insulin emitted by the medical device 104 is not delivered to the user 110 due to a downstream blockage. An upstream blockage may also occur, for example, between the insulin reservoir and the insulin pump if the reservoir is running low. Leaks in the insulin pump or near the infusion site 108 may also occur, resulting in interruption of insulin delivery to the user 110 and reduced effectiveness of such insulin delivery via the medical device 104.

[0015] In an embodiment configuration, the PPG sensor device 102 may be a secondary insulin failure detection mechanism for a medical device 104, which may be an insulin pump that already includes an internal failure detection sensor. Such an internal failure detection sensor may include, for example, a sensor integrated within the insulin pump device either near the reservoir, the pump motor, or downstream of the tubing and cannula, and may measure various force, volume, pressure, and optical changes within the insulin pump device system that may indicate an obstruction. However, such an internal failure detection sensor may not detect an obstruction and sound an alarm until several hours after the obstruction has occurred, which may result in the user 110 moving into a dangerously hyperglycemic state with little warning for intervention. The PPG sensor device 102 described herein may be used to verify or confirm a failure detected internally within the insulin pump, or to identify anomalies before a fault is detected within the insulin pump by the internal failure detection sensor, and to notify the user 110 via the pump controller interface to check pump function and closely monitor the user's blood glucose (bg) levels of a possible impending obstruction alarm from the insulin pump.

[0016] The PPG sensor device 102 operates to detect insulin absorption to the user 110 via the medical device 104 by detecting the resulting physiological response of the user 110 to the delivered insulin. For example, when insulin is delivered to the body, the user's body reacts with a physiological response of the vasculature of vasoconstriction or vasodilation, which changes the volumetric blood flow through the body. In particular, when insulin is released into the body, the body then produces nitric oxide (NO) and / or endothelin (ET-1) compounds. These compounds dilate or constrict the arteries of the vasculature, allowing for higher or lower volumetric blood flow, respectively. PPG is a light sensing technology used to monitor heart rate and heart rate variability, and can measure changes in volumetric blood flow. The PPG process involves shining light, such as from an LED, of one or more different wavelengths, which then measures the amount of light reflected or transmitted to a photodiode. The volumetric change in blood flow causes a change in the amount of light measured by the photodiode. These changes in volumetric blood flow are represented by a PPG signal, such as light of a specific frequency between 375 nm and 550 nm wavelength, although measurements at other frequencies are also possible.

[0017] In embodiments in which the medical device 104 is an insulin pump, the user's 110 insulin absorption may vary over time, and the infusion set wear time at the infusion site 108 may be limited to one to three days before the infusion site 108 must be changed depending on the type of cannula and other local factors. The medical device efficiency detection system 100 may be operative to determine if and when the infusion site 108 needs to be changed. Thus, the medical device efficiency detection system 100 may be operative to inform the user 110 of the infusion set wear time associated with the infusion site 108 in order to most efficiently use the infusion site 108. By advising the user of the infusion set wear time, a well-functioning set is prevented from being prematurely discarded, and further, from being worn for an excessively long period when the set may no longer be optimally performing its associated insulin delivery function.

[0018] Additionally, tissue damage, bruising, local infection, and / or lipohypertrophy (an increase in localized fat cells) may develop as a result of repeated, prolonged use of insulin pumps / infusion sets with poor site turnover. The anatomical and physiological changes present at these "overused" sites may result in decreased insulin absorption and reduced effectiveness, and ultimately unexpected, abnormal glycemic outcomes. Additionally, some sites that are not optimal for infusion placement may include areas with known scar tissue, previous surgical scars, stretch marks, adipose tissue overgrowth, previously infected areas, areas of bruising, or areas that have previously undergone liposuction, and other similar sites that have characteristics that reduce the efficiency of insulin absorption.

[0019] The user may change the infusion set every 1-3 days, but may be instructed not to use the same infusion site 108 for at least two weeks until the infusion site 108 is fully healed. Additionally, once the cannula of the medical device 104 is inserted into one infusion site 108 as an infusion set, the user 110 is typically advised not to remove it and replace the same infusion set for another infusion site 108 due to the risk of infection. The user 110 may use an infusion site rotation pattern to avoid reusing the same site before the site has healed, such that the user 110 may gradually move the infusion site 108 along a particular path (e.g., horizontal, zigzag, curved, crisscross). However, such movements do not guarantee that the next site along the pattern will be optimal for insulin delivery, and the user 110 may make tracking errors that may cause an unreliable or otherwise inefficient site to be used. The medical device efficiency detection system 100 may operate to keep track of where the user's 110 past infusion sites 108 have been and avoid new areas that may not optimally absorb insulin. The medical device efficiency detection system 100 described herein may further operate to effectively identify efficient and appropriate locations for infusion set placement to maintain consistent and predictable insulin delivery for optimal diabetes management and reduce costs associated with poor placement and wasted infusion sets that may have to be prematurely discarded due to local site issues.

[0020] Thus, the PPG sensor device 102 may be further used, as described in more detail below, to determine when to change infusion sites 108 due to reduced insulin absorption to more effectively deliver insulin to the user at the new infusion site 108. Additionally, as described in more detail below, the medical device efficiency detection system 100 may be used to scan potential insulin infusion sites 108 and determine suitability for placing an insulin infusion set, such as the medical device 104. The medical device efficiency detection system 100 may use the PPG sensor device 102 described herein to determine whether insulin is successfully and efficiently delivered to the user 110 to treat diabetes, and may determine when insulin is delivered upon detection of a physiological response to the presence of insulin in response to notification of insulin delivery by the medical device 104. When the user 110 administers insulin via the medical device 104, if no physiological response is measured by the PPG sensor device 102 upon notification of delivery and within a predetermined period of time after notification and delivery, the user 110 may be alerted before a potentially dangerous situation occurs, thereby preventing a potential hyperglycemic condition. The medical device efficiency detection system 100 may further monitor infusion site wear time and optimally identify new infusion sites 108 using the PPG signal from the PPG sensor device 102, as described in more detail below with respect to process 600 of FIG. 8.

[0021] Referring to FIG. 2, a profile 200 of measured physiological responses to the presence of insulin delivered to a user by an insulin delivery device as the medical device 104 of FIG. 1, detected by the PPG sensor device 102 at different wavelengths, is shown. With reference to FIG. 2, the medical device 104 is an insulin pump worn by a user that delivers insulin at a basal rate of 1.15 units per hour, and one bolus of insulin is administered over a test period of 10 minutes. The wavelengths applied are red 202 at 660 nm, blue 204 at 470 nm, infrared (IR) 206 at 940 nm, green 208 at 530 nm, and tan 210. Although the wavelengths are shown in FIG. 2 at specific wavelengths with different frequencies, it is contemplated that wavelengths different from those of FIG. 2 may be utilized by the PPG sensor device 102 within the scope of the present disclosure. As a non-limiting example, the PPG sensor device 102 may transmit one or more different colors of light having wavelengths in the range of 380 nm to 1200 nm along a light spectrum toward the user 110 and measure the corresponding light reflected off a transducer component of the PPG sensor device 102, such as a photodiode, to measure the amount of absorption associated with the transmitted and reflected light. In at least one other embodiment, the PPG sensor device may transmit one or more different colors of light having wavelengths in the range of 380 nm to 1200 nm along a light spectrum toward the user 110 and measure the corresponding light transmitted through a body part to a transducer component of the PPG sensor device 102, such as a photodiode, to measure the amount of absorption associated with the transmitted light. An example of this transmission embodiment may occur at a site such as an earlobe or a fingertip. The x-axis of FIG. 2 represents units of time, and the y-axis represents the absorption of the applicable wavelength of the user's vasculature as detected by the PPG sensor device 102.

[0022] The PPG sensor device 102 is configured to be used as a non-invasive pulse oximeter device for measuring blood oxygen saturation and light absorption. As a pulse oximeter, the PPG sensor device 102 uses spectrophotometry to determine the spectral absorption of different transmitted light wavelengths corresponding to different colors on the light spectrum, and through such measurements determines oxygen concentration levels, and utilizes the PPG method to assess oxygen saturation in the pulsatile arterial blood flow of the vasculature through which light is transmitted. To measure oxygen saturation of arterial blood, the PPG sensor device 102 may filter the absorbance of the pulsatile component of blood by arterial blood as the AC component from the constant absorbance of blood by the non-pulsatile component as the DC H component, as shown in FIG. 4, which will be described in more detail below. When insulin is delivered to the vasculature, dilation of the vasculature occurs, followed by vasoconstriction, indicating the absorption of insulin in the vasculature for a period of time before more light is absorbed and more light is reflected back to the PPG sensor device 102. The PPG sensor device 102 may compare this light absorption measurement to a baseline measurement without insulin delivery, such as a baseline vasoconstriction of the vasculature for the user 110 or a baseline NO value for the user 110. If the light absorption measurement is above the baseline measurement, the PPG sensor device 102 may determine that insulin has been absorbed by the measured vasculature and thus delivered to the user 110.

[0023] With reference to FIG. 2, time period 212 reflects the delivery of 11.2 units of insulin to a user over a five minute period using an insulin pump, and time period 214 reflects a period during which the PPG sensor device 102 subsequently detects one or more measured physiological responses to the presence of insulin as one or more respective peaks 216. For example, during an insulin delivery event, spikes in the raw DC-removed and normalized PPG data or necking features of the PPG data can be seen as one or more respective peaks 216. In contrast, with reference to FIG. 3, a profile 250 of measured physiological responses over a ten minute period detected by the PPG sensor device 102 of FIG. 1 at different wavelengths when insulin is not being delivered to the user by the medical device 104 is shown. The detection of insulin delivery in at least one embodiment includes the identification of a peak 216 at at least one wavelength examined. In additional embodiments, a peak is identified at at least two wavelengths examined to indicate insulin delivery. In additional embodiments, a peak is identified at at least three wavelengths examined to indicate insulin delivery. In additional embodiments, peaks are identified at at least four wavelengths examined to indicate insulin delivery, hi additional embodiments, peaks are identified at at least five wavelengths examined to indicate insulin delivery.

[0024] Referring again to FIG. 2, each peak 216 may be determined based on the difference between two points in a time frame exceeding a threshold to indicate the presence of insulin. As a non-limiting example, two points in a 15 second time frame may have a difference that is more than a 2% increase, overcoming a threshold of a positive 2% change indicating the presence of insulin. In other embodiments, the threshold may be a positive slope change between two points that is more than 3 slope changes, and the period time frame within which the two points are located may be within a range of 10 to 40 seconds. Alternatively, in other embodiments, the threshold may be when there is a calculated value, such as an area under the curve, that exceeds a set threshold time. Additionally, the pulse width of the signal may be used to indicate the threshold.

[0025] Thus, in an embodiment, the PPG sensor device 102 may be placed in closed-loop communication with a medical device 104, such as an insulin delivery device. Communication between the devices may be used to provide notifications indicating when basal or bolus insulin is delivered by the medical device 104. Upon receiving the delivery notification, the connected PPG sensor device 102 may be used to monitor a raw or filtered spectral signature for a period of time that correlates with insulin activity in the user's 110 body in response to insulin delivery. In an embodiment, as shown in FIG. 2, such a specific signature may include a sharp rise in the raw PPG signal similar to a DC shift. When the signal is normalized and filtered to remove the DC portion, a narrowing or necking of the signal may occur. Such a specific signature to indicate insulin absorption in the user 110 may occur instantaneously or up to about 5 minutes after insulin delivery. If such a signature is not seen within a certain time threshold after the delivery notification, a warning may be sent to the user to alert them to the situation before a dangerous health condition is experienced. Additionally, the user 110 may be advised to monitor their blood glucose levels via a self-monitoring blood glucose device or continuous blood glucose monitor to look for increases and trends in blood glucose levels.

[0026] For example, as shown in Figure 2, there is a clear pattern in the PPG sawtooth waveform to illustrate the physiological response from the presence of vasodilators and vasoconstrictors as a result of insulin administration. For the raw PPG signal after bandpass or notch filters remove noise, a dose or release of insulin may cause a gradual increase in the DC signal, eventually returning to the normal DC baseline after about 10-40 seconds. Furthermore, when comparing the peaks of different wavelengths of light in the sawtooth waveform for the same heart attack, the time difference between the peak heights may be affected. For example, by comparing the PPG signal from red light with the PPG signal from UV light, the peaks of red light are longer than the T red The peak of UV light can be reached at T UV It can be reached by T red and T UVThe difference or delta between may change as a result of insulin being administered (e.g., released) to the user 110. Additionally, R values, such as those used in pulse oximetry calculations, may also be affected, and such R values ​​may be used to compare the AC and DC portions of one wavelength of light with another wavelength to detect insulin absorption.

[0027] For PPG signals where the DC portion of the signal has been removed, the PPG signal may show lower amplitudes or peak heights over a period of approximately 10-40 seconds after insulin administration / release. Additionally, the time difference between peak heights for different wavelengths of light may also be affected.

[0028] Since the PPG signal is susceptible to noise, the PPG signal may undergo a DC shift as a result of motion. Thus, the medical device efficiency detection system 100 may be configured to operate in closed-loop communication and indicate when a bolus is delivered by the medical device 104 and when a DC shift is detected by the PPG sensor device 102 within a predetermined period of time after delivery to ensure that the DC shift indicates insulin delivery and not motion. Additionally, an on-board accelerometer may be used to determine whether excessive motion contributes to the DC shift after an insulin administration event. Other factors that cause noise on the PPG signal of the PPG sensor device 102 may include ambient light conditions, temperature, the amount of pressure applied to the sensor surface, respiratory rate, sweating level between the skin and the device, or variable heart rate. The medical device efficiency detection system 100 may be configured to filter the PPG signal by an applied filter to reduce such noise.

[0029] FIG. 4 shows a schematic diagram 270 of an example PPG sensor device signal from the PPG sensor device 102 that may correspond to underlying tissue and vasculature. For example, as described in more detail below with respect to FIG. 8, the PPG sensor device 102 may be used to check an infusion site to determine whether it is sufficient to be used to efficiently deliver insulin. In the schematic diagram 270, the tissue, venous blood, and non-pulsatile arterial blood represent DC components of the respective PPG signals received by the PPG sensor device 102, and the pulsatile arterial blood represents AC components of the received PPG signals to indicate pulsation via contraction and expansion of the underlying blood vessels. Thus, if the PPG signal of the pulsatile arterial blood at the tested infusion site does not provide sufficient amplitude or an appropriate AC component, the medical device efficiency detection system 100 may determine that the tested infusion site is not sufficient to be used to deliver insulin (e.g., does not include sufficient underlying vasculature for insulin absorption) compared to another infusion site that may also be tested for sufficiency.

[0030] 5, a system 300 for implementing a computer and software-based method for utilizing a medical device efficiency detection system as shown in FIG. 1 is shown and may be implemented, for example, using a graphical user interface (GUI) accessible at a user workstation (e.g., computer 324). The system 300 includes a communication path 302, one or more processors 304, a memory component 306 (e.g., memory 306), a PPG sensing component 312, a storage or database 314, a treatment delivery component 316, a network interface hardware 318, a server 320, a network 322, and at least one computer 324. The various components of the system 300 and their interactions are described in detail below.

[0031] Although only one application server 320 and one user workstation computer 324 are shown, the system 300 can include multiple workstations and application servers containing one or more applications that can be located in geographically diverse locations across multiple industrial sites. In some embodiments, the system 300 is implemented using a wide area network (WAN) or network 322, such as an intranet or the Internet, or other wired or wireless communication networks that can include cloud computing-based network configurations (e.g., clouds). The workstation computer 324 can include digital systems and other devices that allow connection to and navigation of the network. Other variations of the system 300 that allow communication between various geographically diverse components are also possible. The lines shown in FIG. 5 indicate communication rather than physical connections between the various components.

[0032] As discussed above, the system 300 includes a communication path 302. The communication path 302 may be formed from any medium capable of transmitting a signal, such as, for example, a conductor wire, a conductive trace, an optical waveguide, or a combination of media capable of transmitting a signal. The communication path 302 communicatively couples the various components of the system 300. As used herein, the term "communicatively coupled" means that the coupled components can exchange data signals with each other, such as, for example, electrical signals through a conductive medium, electromagnetic signals through the air, optical signals through an optical waveguide, and the like.

[0033] As mentioned above, the system 300 includes a processor 304. The processor 304 may be any device capable of executing machine-readable instructions. Thus, the processor 304 may be a controller, an integrated circuit, a microchip, a computer, or any other computing device. The processor 304 is communicatively coupled to other components of the system 300 by a communication path 302. Thus, the communication path 302 may communicatively couple any number of processors to each other, allowing the modules coupled to the communication path 302 to operate in a distributed computing environment. In particular, each of the modules may operate as a node that may transmit and / or receive data. The processor 304 may process input signals received from the system modules and / or extract information from such signals.

[0034] As described above, the system 300 includes a memory component 306 coupled to the communication path 302 and communicatively coupled to the processor 304. The memory component 306 may be a non-transitory computer-readable medium or a non-transitory computer-readable memory and may be configured as a non-volatile computer-readable medium. The memory component 306 may include a RAM, a ROM, a flash memory, a hard drive, or any device capable of storing machine-readable instructions such that the machine-readable instructions may be accessed and executed by the processor 304. The machine-readable instructions may include, for example, logic or algorithms written in a machine language that may be directly executed by the processor, or in any programming language such as assembly language, object-oriented programming (OOP), scripting language, microcode, etc. that may be compiled or assembled into machine-readable instructions and stored in the memory component 306. Alternatively, the machine-readable instructions may be written in a hardware description language (HDL), such as logic implemented via either a field programmable gate array (FPGA) configuration or an application-specific integrated circuit (ASIC), or equivalents thereof. Thus, the methods described herein may be implemented in any conventional computer programming language, as preprogrammed hardware elements, or as a combination of hardware and software components. In an embodiment, the system 300 may include a processor 304 communicatively coupled to a memory component 306 that stores instructions that, when executed by the processor 304, cause the processor to perform one or more functions as described herein.

[0035] 5, as described above, the system 300 includes a display, such as a GUI on a screen of the computer 324 for providing visual output, such as information, graphic reports, messages, or combinations thereof. The computer 324 may include one or more computing devices across platforms, or may be communicatively coupled to devices across platforms, such as mobile smart devices, including smartphones, tablets, laptops, and the like, or medical devices, such as blood glucose meters, insulin pumps, continuous blood glucose monitors, and the like. The display on the screen of the computer 324 is coupled to the communication path 302, which is communicatively coupled to the processor 304. Thus, the communication path 302 communicatively couples the display to other modules of the system 300. The display may include any medium capable of transmitting an optical output, such as, for example, a cathode ray tube, a light emitting diode, a liquid crystal display, a plasma display, and the like. Additionally, it is noted that the display or the computer 324 may include at least one of the processor 304 and the memory component 306. Although the system 300 is shown in FIG. 5 as a single integrated system, in other embodiments, the system may be a separate system.

[0036] The system 300 includes a PPG sensing component 312, such as a PPG sensor device 102 described herein, and a treatment delivery component 316, such as a medical device 104 configured to administer a treatment therapy described herein. The PPG sensing component 312 and the treatment delivery component 316 are coupled to a communication path 302 and communicatively coupled to a processor 304. As described in further detail below, the processor 304 may process input signals received from system modules and / or extract information from such signals.

[0037] The system 300 includes network interface hardware 318 for communicatively coupling the system 300 to a computer network, such as network 322. The network interface hardware 318 is coupled to the communication path 302 such that the communication path 302 communicatively couples the network interface hardware 218 to other modules of the system 300. The network interface hardware 318 may be any device capable of transmitting and / or receiving data over a wireless network. Thus, the network interface hardware 318 may include a communication transceiver for transmitting and / or receiving data according to any wireless communication standard. For example, the network interface hardware 318 may include a chipset (e.g., antenna, processor, machine-readable instructions, etc.) for communicating over wired and / or wireless computer networks, such as, for example, Wireless Fidelity (Wi-Fi), WiMax, Bluetooth, IrDA, Wireless USB, Z-Wave, ZigBee, etc.

[0038] 5, data from various applications running on computer 324 can be provided to system 300 from computer 324 via network interface hardware 318. Computer 324 can be any device having hardware (e.g., a chipset, processor, memory, etc.) for communicatively coupling with network interface hardware 318 and network 322. In particular, computer 324 can include an input device having an antenna for communicating over one or more of the wireless computer networks described above.

[0039] The network 322 may include any wired and / or wireless network, such as, for example, a wide area network, a metropolitan area network, the Internet, an intranet, a cloud 323, a satellite network, etc. Thus, the network 322 may be utilized as a wireless access point by the computer 324 to access one or more servers (e.g., the server 320). The server 320 and any additional servers, such as a cloud server, generally include a processor, memory, and chipset for delivering resources over the network 322. The resources may include, for example, providing processing, storage, software, and information from the server 320 to the system 300 over the network 322. It should further be noted that the server 320 and any additional servers may share resources with each other over the network 322, such as, for example, over a wired portion of the network, a wireless portion of the network, or a combination thereof.

[0040] 6-7, processes 400, 500, respectively, are shown for using the medical device efficiency detection system 100 of FIG. 1 with the system 300 of FIG. 5 to implement processes 400, 500 described herein. In an embodiment, the medical device efficiency detection system 100 includes a PPG sensor device 102, a medical device 104 configured to administer a therapeutic treatment, a processor 304 communicatively coupled to the PPG sensor device and the medical device, a memory 306 communicatively coupled to the processor 304, and machine-readable instructions stored in the memory 306. The machine-readable instructions, when executed by the processor 304, may cause the medical device efficiency detection system 100 to perform the processes 400, 500.

[0041] With respect to the process 400, in block 402, the PPG sensor device 102 is communicatively coupled to the medical device 104. In block 404, the PPG sensor device 102 can be connected to a user 110.

[0042] At block 406, the medical device 104 may be an insulin delivery device connected to the user 110, and an insulin bolus may be delivered to the user via the medical device 104. Upon delivery of the insulin bolus, the medical device 104 may send a notification of the delivery to the PPG sensor device 102. Thus, at block 406, the system 300 may be configured to deliver a therapeutic treatment to the user at the infusion site 108 via the medical device 104, and receive a notification at the PPG sensor device 102 from the medical device 104 upon delivery of the therapeutic treatment.

[0043] In block 408, the PPG sensor device 102 is used to measure a signal response at the user 110 within a predetermined period of time based on the received notification. search Thus, in block 406, the system 300 may use the PPG sensor device 102 to monitor the signal response of the user 110 to generate a response signal indicative of a therapeutic treatment delivery by the medical device 104 within a predetermined time period based on the delivery notification sent by the medical device 104. search The device may be configured to:

[0044] At block 410, the user 110 may be notified when a response signal indicative of insulin absorption is not generated within a predetermined period of time, thereby notifying the user 110 of a failure by the PPG sensor device 102 to detect sufficient insulin delivery to the user 110 by the medical device 104. In an embodiment, the system 300 generates a response signal indicative of delivery of a therapeutic treatment. Where If it is not generated within the specified period , indicating that sufficient therapeutic treatment delivery could not be detected. It may be configured to send an alert.

[0045] In embodiments, the system 300 may be further configured to transmit an alert when the response signal is generated after a delay period within a predetermined period. Additionally or alternatively, the system 300 may be configured to transmit an alert if the response signal generated within a predetermined period is below a threshold. If the response signal generated is below a threshold, the alert may include instructions to move the infusion site 108 to another location on the user 110.

[0046] With respect to process 500, process steps 502-508 correspond to process steps 402-408 of process 400. However, in block 510, process 500 differs from process 400 in that the user 110 may be notified not only when a response signal indicative of insulin absorption is not generated within a predetermined period of time, but also when a delayed or reduced response signal indicative of a failure to detect sufficient insulin delivery is generated by the PPG sensor device 102. Thus, either no detection by the medical device 104 or reduced (e.g., below an acceptable threshold indicative of sufficient insulin absorption) or delayed detection notifies the user 110 of a failure by the PPG sensor device 102 to detect sufficient insulin delivery to the user 110. In an embodiment, the system 300 ,Response if a response signal is not generated by the PPG sensor device 102 within a predetermined period of time, if a response signal is generated after a delay period within the predetermined period of time, if the response signal generated within the predetermined period of time is below a threshold value, or any combination thereof. Indicates failure to detect adequate therapeutic treatment delivery It may be configured to send an alert.

[0047] Thus, the PPG sensor device 102 may act as a mechanism to alert the user 110 when it is time to change the infusion site 108. Thus, the associated infusion set wear time at the infusion site 108 may be personalized to the user 110 based on the effectiveness of insulin absorbed over time, as monitored by the PPG sensor device 102. For example, the signal may be monitored during the entire wear time, and the PPG sensor device 102 may detect changes in the signal response, such as the timing at which a response is seen, the amplitude of the response, the area under the curve, and / or the lack of a specified signal response. search The device may be configured to:

[0048] When a new infusion set is placed, the PPG sensor device 102 may generate, store, and monitor how long after an insulin administration event communicated from the connected medical device 104 a peak 216 can be detected, as well as associated peak amplitude and / or area under the curve of the peak. Such parameters may be recorded for each subsequent programmed insulin dose, and the medical device efficiency detection system 100 may be configured to monitor for changes to indicate a decrease in efficiency of insulin delivery to the user 110. Such changes may include a delay in the insulin dose peak (e.g., an increase in time to peak), a decrease in amplitude for a given dose, or an area under the curve for a given dose below a certain threshold (e.g., a 5 second delay from the original administration event to the peak, 80% of the original peak amplitude / area under the curve). Detection of such changes may operate to trigger an alarm condition by the medical device efficiency detection system 100 to inform the user 110 that the infusion set for the monitored infusion site 108 is approaching or has passed the associated operational wear time and should be changed soon. It should be understood that the thresholds applied and monitored may vary from patient to patient depending on user 110 patient factors such as the level of control the patient requires and the patient's ability to adjust basal and bolus rates to counter the wearing of the infusion set.

[0049] In an embodiment of the process 400, 500, the medical device 104 may be an insulin delivery device and the therapeutic treatment may include an insulin bolus. The insulin delivery device may be one of an insulin pump, an insulin injection pen, an insulin inhaler, or an insulin shot. If the insulin administration is from an insulin injection pen, the insulin injection pen may be a wirelessly connected pen configured to transmit the dosage and timing to a monitoring device where other disease-related data is captured. The insulin event may be captured from a sensor in the insulin injection pen configured to track part of the mechanical movement of the injection action or insulin level change in the cartridge of the insulin injection pen. However, such mechanical movement action may be indistinguishable from the priming of the insulin injection pen after a new cartridge is inserted into the insulin injection pen. The PPG sensor device 102 may be used to distinguish such priming events and confirm the delivery of insulin via the insulin injection pen rather than a priming action to avoid giving a false positive for an insulin event, thus more accurately verifying the actual injection of insulin by the medical device 104 before the data is shared with the monitoring device.

[0050] Thus, if the medical device 104 is an insulin injection pen, the communicatively connected PPG sensor device 102 located on the user 110 may monitor the spectral signal for a predetermined period of time following the detected pen injection action. The PPG sensor device 102 may thus be used to determine whether insulin was actually injected into the user or whether the monitored action was rather a priming air shot injection action, in which case the system 300 may be configured to record the monitored action as a priming action (rather than an insulin delivery action) on the monitoring device, or may be configured to not record the determined priming action at all. In embodiments where the insulin injection pen is not a smart pen or wirelessly connected pen, the communicatively connected PPG sensor device 102 may be used to identify an insulin injection event as described herein and send a notification signal of the identified insulin injection event to the monitoring device. At the monitoring device, upon receiving the notification signal, the user 110 may be prompted to provide additional input, such as confirming the injection and providing specific information such as the number of units, type of insulin, injection time, and similar injection details.

[0051] Furthermore, as mentioned above, the system 300 may be configured to filter the signal response by an applied filter. The applied filter may be a bandpass filter or a notch filter to reduce noise. A bandpass filter may be configured to allow frequencies within a determined band to pass those frequencies and reject other frequencies below or above those allowed frequencies. A notch filter may be configured to act as a bandstop filter to alternatively reject frequencies within the determined band while accepting other frequencies below or above the rejected frequencies. The signal response may be normalized and scaled and the applied filter may remove the corresponding DC portion.

[0052] In an embodiment, the PPG sensor device 102 may be used with the medical device efficacy detection system 100 to determine the suitability of the tissue underlying the infusion site 108 before the infusion set of the medical device 104 is inserted and set up at the infusion site 108. Using the PPG sensor device 102, the user 110 may analyze the blood flow at the desired infusion site 108 before the medical device 104 is inserted to determine whether the infusion site 108 contains undesirable abnormalities that affect its sufficiency as an infusion site 108 for efficient treatment delivery, such as scar tissue. Based on the PPG characteristics and signal quality detected by the PPG sensor device 102 and further described below in FIG. 8, a determination may be made of the suitability of the infusion site 108 for insulin infusion before the infusion site 108 is placed, or even whether other more suitable infusion sites 108 may be available.

[0053] 8, a process 600 is shown for using the medical device efficiency detection system 100 of FIG. 1 with the system 300 of FIG. 5 implementing the process 600 described herein to test whether the infusion site 108 is sufficient for insulin delivery. In an embodiment, the medical device efficiency detection system 100 may include a PPG sensor device 102, a processor 304 communicatively coupled to the PPG sensor device 102, a memory 306 communicatively coupled to the processor 304, and machine readable instructions stored in the memory 306. The machine readable instructions, when executed by the processor 304, may cause the medical device efficiency detection system 100 to perform the process 600.

[0054] With respect to process 600, at block 602, an infusion site 108 is determined for use by the medical device 104, such as to deliver insulin as an insulin delivery device to a user 110 at the infusion site 108. The infusion site 108 may be tested for sufficiency of insulin delivery prior to delivering insulin to the user 110 via process 600.

[0055] At block 604, the PPG sensor device 102 is connected to the user 110 above the determined infusion site 108 for testing. In an embodiment, the system 300 is configured to use a PPG sensor device 102 positioned above the tested infusion site 108 of the user 110, the infusion site 108 being the location of the user 110 where the medical device 104 is to administer a therapeutic procedure.

[0056] In block 606, measurements from the PPG sensor device 102 for the underlying tissue and vasculature at the tested infusion site 108 may be generated, for example, via the underlying tissue and vasculature signals shown in diagram 270 of Figure 4. Thus, the system 300 may be configured to generate signal measurements from the PPG sensor device 102 for the tissue and vasculature underlying the infusion site 108 being tested for sufficiency.

[0057] At block 608, the response signal generated by the PPG sensor device 102 may be analyzed to determine the sufficiency of the tested infusion site 108 for insulin delivery. Thus, the system 300 may be configured to determine whether the signal measurements are within a sufficient signal range such that the infusion site 108 being tested is sufficient for delivery of a therapeutic treatment by the medical device 104.

[0058] At block 610, the user 110 may be notified when the response signal indicates that the infusion site 108 being tested is not sufficient for insulin delivery, whereby a different infusion site 108 is analyzed for sufficiency through the process 600 until an infusion site 108 sufficient for insulin delivery is tested. Thus, in an embodiment, the system 300 may be configured to send a warning when the signal measurement is not within a sufficient signal range to indicate that the infusion site 108 being tested is insufficient for delivery of a therapeutic treatment by the medical device 104.

[0059] If the infusion site signal measurement is not within a sufficient signal range, the PPG sensor device 102 may be positioned over one or more other infusion sites 108 to analyze the respective signal measurements until one of the one or more other infusion site signal measurements is within a sufficient signal range. The medical device efficacy detection system 100 for implementing the process 600 may further include a medical device 104 configured to administer a therapeutic treatment, and the processor 304 may be communicatively coupled to the PPG sensor device 102 and the medical device 104.

[0060] The system 300 may be configured to send a command to place the medical device 104 at the sufficient infusion site when the signal measurement of the infusion site 108 or one of the signal measurements of one or more other infusion sites 108 is within a sufficient signal range indicating a sufficient infusion site. A treatment therapy may then be delivered to the user 110 at the sufficient infusion site 108 using the medical device 104. For example, at block 612, the medical device 104 may be an insulin delivery device placed at the infusion site 108 or another tested infusion site 108 determined to be sufficient for insulin delivery via process 600 upon such determination of site sufficiency.

[0061] In an embodiment, the handheld PPG sensor device 102 may be incorporated into the medical device 104, which may be an infusion set or pump, or may be incorporated into a separate dedicated infusion set placement sensor. Prior to placing a new infusion set at the infusion site 108, the handheld PPG sensor device 102 may pass over potential infusion sites 108 of the user 110, such as the abdomen, back arm, chest, thigh, or other suitable infusion area, to identify an optimal infusion site 108. Furthermore, calibration of the PPG sensor device 102 may be performed at least upon first use by the user 110 to determine the particular tissue characteristics of the user 110 and establish a spectral baseline before an optimal site can be detected as the infusion site 108. By way of example and not by way of limitation, the user 110 may be instructed to scan with the PPG sensor device 102 an area on the abdomen where the user 110 has a predictable and consistent insulin delivery experience, and then scan other areas where suboptimal insulin absorption is expected, such as areas with more fat or denser tissue, to calibrate the PPG sensor device 102 and help the PPG sensor device 102 identify areas as sufficient or insufficient.

[0062] The PPG sensor device 102 may be placed over the tested infusion site 108 for a period of time, such as a few seconds, to collect signals representative of the tissue and vasculature local to the tested infusion site 108 before providing a direct indication to either the handheld PPG sensor device 102 or another connected device of the suitability of the tested infusion site 108 as described herein. The indication may be binary, as a text or other visual signal (e.g., good or bad, green or red light), or a high resolution indication indicating the degree to which the site is suitable for optimal insulin delivery (e.g., a visual indication of low, medium, high, 1-10, or similar rank-based indication). After identifying the infusion site 108 as a suitable infusion site, the user may proceed to place a new infusion set as the medical device 104 at the infusion site 108 and deliver insulin to the user 110 via the medical device 104.

[0063] Thus, the medical device efficiency detection system 100 and system 300 described herein may be configured to non-invasively detect when insulin is not properly delivered by the medical device 104 to the user 110 for a diabetic patient, provide algorithms and control loops to compare responses from multiple inputs to determine whether insulin was actually delivered, and provide inter-device communication to exchange data to determine whether insulin was delivered. Additionally, the medical device efficiency detection system 100 and system 300 may be configured to implement a control loop to compare insulin absorption effects over time and create individual infusion site wear times for the infusion sites 108 in order to more efficiently and effectively use the infusion sites 108 to deliver insulin. The medical device efficiency detection system 100 and system 300 may further be configured to be used to scan tissue areas before the infusion set of the medical device 104 is inserted into the infusion site 108 to determine an infusion site 108 suitable for insulin infusion based on subcutaneous and non-visible characteristics analyzed as described herein by the PPG sensor device 102 of the medical device efficiency detection system 100.

[0064] Item Enumeration

[0065] Item 1. A medical device efficiency detection system may include a PPG sensor device, a medical device configured to administer a therapeutic treatment, a processor communicatively coupled to the PPG sensor device and the medical device, a memory communicatively coupled to the processor, and machine-readable instructions stored in the memory. The machine-readable instructions, when executed by the processor, cause the medical device efficiency detection system to at least: communicatively connect the PPG sensor device and the medical device; deliver a therapeutic treatment to a user at an infusion site via the medical device; receive a notification at the PPG sensor device from the medical device upon delivery of the therapeutic treatment; and use the PPG sensor device to measure a signal response of the user based on the notification within a predetermined period of time. search generating a response signal indicative of therapeutic treatment delivery; and Response If a response signal is not generated within a predetermined period of time, Indicates failure to detect adequate therapeutic treatment deliverySending a warning.

[0066] Item 2. The medical device efficiency detection system of item 1, wherein the machine-readable instructions further include instructions for transmitting an alert if the response signal is generated after a delay period within a predetermined period.

[0067] Item 3. The medical device efficiency detection system of item 1 or 2, wherein the machine-readable instructions further include instructions for sending an alert if the response signal generated within a predetermined period of time is below a threshold value.

[0068] Item 4. The medical device efficacy detection system of item 3, wherein if the generated response signal is below a threshold value, the alert includes instructions to move the injection site to another position on the user.

[0069] Item 5. The medical device efficiency detection system of any one of items 1 to 4, wherein the medical device is an insulin delivery device and the therapeutic treatment is an insulin bolus.

[0070] Item 6. The medical device efficiency detection system of item 5, wherein the insulin delivery device is one of an insulin pump, an insulin injection pen, an insulin inhaler, or an insulin shot.

[0071] Item 7. The medical device efficiency detection system of any one of items 1 to 6, wherein the machine-readable instructions further include instructions for filtering the signal response with the applied filter.

[0072] Item 8. The medical device efficiency detection system according to item 7, wherein the applied filter includes one of a band pass filter and a notch filter for reducing noise.

[0073] Item 9. A medical device efficiency detection system according to any one of items 1 to 8, wherein the signal response is normalized and an applied filter removes the corresponding DC portion.

[0074] Item 10. A medical device efficiency detection system as described in any one of items 1 to 9, wherein the PPG sensor device is a separate wearable device configured to be placed in an area of ​​the user away from the injection site.

[0075] Item 11. The medical device efficacy detection system of Item 10, wherein the PPG sensor device is a wristband, a ring, a finger clip, an adhesive patch, a toe clip, an earbud-type device, an earring, or a forehead band.

[0076] Item 12. The medical device efficacy detection system of Item 10, wherein the PPG sensor device is a mobile smart device, and a camera and a flash of the mobile smart device are configured to function as a photodiode and a light source, respectively, of the PPG sensor device.

[0077] Item 13. A medical device efficiency detection system according to any one of items 1 to 9, wherein the PPG sensor device is integrated with the medical device.

[0078] Item 14. A medical device efficiency detection system may include a PPG sensor device, a medical device configured to administer a therapeutic treatment, a processor communicatively coupled to the PPG sensor device and the medical device, a memory communicatively coupled to the processor, and machine-readable instructions stored in the memory. The machine-readable instructions, when executed by the processor, cause the medical device efficiency detection system to at least: communicatively connect the PPG sensor device and the medical device; deliver the therapeutic treatment to a user at an infusion site via the medical device; receive a notification at the PPG sensor device from the medical device upon delivery of the therapeutic treatment; and use the PPG sensor device to generate a response signal indicative of delivery of the therapeutic treatment based on the notification within a predetermined period of time. search To do, and Location if no response signal is generated within the predetermined period of time, if a response signal is generated after a delay period within the predetermined period of time, if the response signal generated within the predetermined period of time is less than a threshold value, or any combination thereof; Indicates failure to detect adequate therapeutic treatment delivery Sending a warning.

[0079] Item 15. The medical device efficacy detection system of item 14, wherein if the generated response signal is below a threshold value, the alert includes instructions to move the injection site to another position on the user.

[0080] Item 16. The medical device efficacy detection system of item 14 or item 15, wherein the PPG sensor device is a separate wearable device configured to be placed in an area of ​​the user away from the injection site.

[0081] Item 17. A medical device efficiency detection system according to item 14 or 15, wherein the PPG sensor device is integrated with the medical device.

[0082] Item 18. A medical device efficiency detection system may include a PPG sensor device, a processor communicatively coupled to the PPG sensor device, a memory communicatively coupled to the processor, and machine-readable instructions stored in the memory. The machine-readable instructions, when executed by the processor, may cause the medical device efficiency detection system to at least: position a PPG sensor device over an infusion site of a user where the medical device administers a therapeutic treatment; generate signal measurements from the PPG sensor device related to tissue and vasculature underlying the infusion site; determine whether the signal measurements are within a sufficient signal range such that the infusion site is sufficient for delivery of the therapeutic treatment by the medical device; and send an alert if the signal measurements are not within a sufficient signal range to indicate that the infusion site is insufficient for delivery of the therapeutic treatment by the medical device.

[0083] Item 19. The medical device efficiency detection system of item 18, wherein the machine-readable instructions further include instructions for, if the signal measurement at the infusion site is not within a sufficient signal range, positioning the PPG sensor device over one or more other infusion sites and analyzing each of the signal measurements until one of the signal measurements at the one or more other infusion sites falls within a sufficient signal range.

[0084] Item 20. The medical device efficacy detection system of item 19, further comprising a medical device configured to administer a therapeutic treatment, the medical device further comprising a processor communicatively coupled to the PPG sensor device and the medical device. The machine readable instructions further comprise instructions for placing the medical device at a sufficient infusion site and using the medical device to deliver a therapeutic treatment to the user at the sufficient infusion site when the infusion site signal measurement or one of the one or more other infusion site signal measurements is within a sufficient signal range indicating a sufficient infusion site.

[0085] It should be noted that the enumeration herein of components of the present disclosure that are "configured" or "programmed" in a particular way to embody certain properties or to function in a particular manner is a structural enumeration, as opposed to a enumeration of intended use. More specifically, references herein to the manner in which a component is "configured" or "programmed" refer to the existing physical state of the component, and thus should be interpreted as an explicit enumeration of the structural characteristics of the component.

[0086] It should be noted that the terms "substantially" and "about" and "approximately" may be utilized herein to express the inherent degree of uncertainty that may result from any quantitative comparison, value, measurement, or other representation. The terms "substantially" and "about" are also utilized herein to express the degree to which a quantitative representation can vary from the stated basis without resulting in a change in the basic functionality of the subject matter in question.

[0087] While particular embodiments have been illustrated and described herein, it should be understood that various other variations and modifications may be made without departing from the spirit and scope of the claimed subject matter. Moreover, although various aspects of the claimed subject matter have been described herein, such aspects need not be utilized in combination. It is therefore intended that the appended claims cover all such variations and modifications that are within the scope of the claimed subject matter.

Claims

1. 1. A medical device efficiency detection system, comprising: a photoplethysmography (PPG) sensor device; a medical device configured to administer a therapeutic treatment; a processor communicatively coupled to the PPG sensor device and the medical device; a memory communicatively coupled to the processor; The machine-readable instructions stored in the memory, when executed by the processor, cause the medical device efficiency detection system to: communicatively connecting the PPG sensor device and the medical device; delivering the therapeutic treatment to a user at an injection site via the medical device; receiving a notification at the PPG sensor device from the medical device upon delivery of the therapeutic treatment; using the PPG sensor device to look for a signal response of the user based on the notification within a period of time and generate a response signal indicative of a therapeutic treatment delivery; and and if the response signal is not generated within the time period, transmitting an alert indicating a failure to detect sufficient therapeutic treatment delivery. the machine readable instructions further comprising instructions for transmitting the alert if the response signals generated within the time period are below a threshold; A medical device efficiency detection system, wherein if the generated response signal is below the threshold, the alert includes instructions to move the injection site to another location on the user.

2. The medical device efficiency detection system of claim 1 , wherein the machine-readable instructions further comprise instructions for transmitting the alert when the response signal is generated after a delay period within the period.

3. The medical device efficiency detection system of claim 1 , wherein the medical device comprises an insulin delivery device and the therapeutic treatment comprises an insulin bolus.

4. 4. The medical device efficiency detection system of claim 3, wherein the insulin delivery device comprises one of an insulin pump, an insulin injection pen, an insulin inhaler, or an insulin shot.

5. The medical device efficiency detection system of claim 1 , wherein the machine-readable instructions further comprise instructions for filtering the signal response with an applied filter.

6. The medical device efficiency detection system of claim 5 , wherein the applied filter comprises one of a bandpass filter and a notch filter for reducing noise.

7. The medical device efficiency detection system of claim 5 , wherein the signal response is normalized and the applied filter removes a corresponding DC portion.

8. The medical device efficacy detection system of claim 1 , wherein the PPG sensor device comprises a separate wearable device configured to be placed in an area of ​​the user remote from the injection site.

9. The medical device efficacy detection system of claim 8 , wherein the PPG sensor device comprises a wristband, a ring, a finger clip, an adhesive patch, a toe clip, an earbud type device, an earring, or a forehead band.

10. 10. The medical device efficiency detection system of claim 8, wherein the PPG sensor device comprises a mobile smart device, a camera and a flash of the mobile smart device configured to function as a photodiode and a light source, respectively, of the PPG sensor device.

11. The medical device efficiency detection system of claim 1 , wherein the PPG sensor device is integrated with the medical device.

12. 1. A medical device efficiency detection system, comprising: a photoplethysmography (PPG) sensor device; a medical device configured to administer a therapeutic treatment; a processor communicatively coupled to the PPG sensor device and the medical device; a memory communicatively coupled to the processor; The machine-readable instructions stored in the memory, when executed by the processor, cause the medical device efficiency detection system to: communicatively connecting the PPG sensor device and the medical device; delivering the therapeutic treatment to a user at an injection site to which the medical device is connected; receiving a notification at the PPG sensor device from the medical device upon delivery of the therapeutic treatment; using the PPG sensor device to look for a signal response of the user based on the notification within a period of time and generate a response signal indicative of a therapeutic treatment delivery; and sending an alert indicating failure to detect sufficient therapeutic treatment delivery if the response signal is not generated within the period of time, if the response signal is generated after a delay period within the period of time, if the response signal generated within the period of time is below a threshold, or a combination thereof; A medical device efficiency detection system, wherein if the generated response signal is below the threshold, the alert includes instructions to move the injection site to another location on the user.

13. The medical device efficacy detection system of claim 12 , wherein the PPG sensor device comprises a separate wearable device configured to be placed in an area of ​​the user remote from the injection site.

14. The medical device efficiency detection system of claim 12 , wherein the PPG sensor device is integrated with the medical device.

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