INJECTION SYSTEM

Abstract

A smart injection system that promotes patient safety includes, among other things, a smart stem that allows for measuring the location of the injection relative to the patient's face and/or the amount of medication injected into the patient. In addition, the smart stem has medication cartridge verification and injector verification features. The smart stem wirelessly transmits the measure data to a processing system.

Claims

1.-73. (canceled)

74. A method of automatically assessing accuracy in an injection procedure performed on a live patient, the method comprising: providing an injection system comprising: a testing tool including a syringe, wherein the syringe comprises a plunger, a syringe body, and a needle, the syringe configured to deliver a medication to the live patient at a predetermined target location, an efficacy or safety of the medication depending at least in part on an accuracy of an injection location; and a detection system coupled to the testing tool for detecting the testing tool relative to the live patient, the detection system comprising an electronics assembly that includes a position sensor; receiving and analyzing, by a processor in communication with the electronics assembly, injection performance data of an injection procedure performed on the live patient with the testing tool to deliver the medication to the live patient; and outputting warnings in response to detecting errors in the injection procedure based at least in part on the collected and analyzed data.

75. The method of claim 74, further comprising determining the needle is in an approved injection zone in the live patient.

76. The method of claim 75, wherein the error comprises the needle not being in the approved injection zone.

77. The method of claim 74, wherein the error comprises the needle being in a no-injection zone in the live patient.

78. The method of claim 74, wherein the detection system comprises a plunger displacement sensor.

79. The method of claim 78, wherein the error comprises a volume of the medication injected into the live patient being inaccurate.

80. The method of claim 78, wherein the error comprises a rate of injection of the medication or an injection force exceeding a threshold.

81. The method of claim 78, wherein the error comprises the needle being in an artery of the live patient.

82. The method of claim 81, wherein the error of the needle being in the artery is detected by determining a relationship of a measured injection force or pressure and a measured rate of plunger displacement.

83. The method of claim 74, wherein the warning comprises audio, visual, or tactile feedback, or any combinations thereof

84. An injection system configured to automatically assess accuracy in an injection procedure performed on a live patient, the system comprising: a testing tool including a syringe, wherein the syringe comprises a plunger, a syringe body, and a needle, the syringe configured to deliver a medication to the live patient at a predetermined target location, an efficacy or safety of the medication depending at least in part on an accuracy of an injection location; and a detection system coupled to the testing tool for detecting the testing tool relative to the live patient, the detection system comprising an electronics assembly that includes a position sensor, wherein the detection system is configured to be in communication with a processor and output to the processor injection performance data on the injection procedure performed on the live patient, the injection procedure being performed using the testing tool to deliver the medication to the live patient, and wherein the processor is configured to: receive and analyze the injection performance data; and output warnings in response to detecting errors in the injection procedure based at least in part on the collected and analyzed data.

85. The system of claim 84, wherein the processor is configured to determine the needle being in an approved injection zone in the live patient.

86. The system of claim 85, wherein the error comprises the needle not being in the approved injection zone.

87. The system of claim 84, wherein the error comprises the needle being in a no-injection zone in the live patient.

88. The system of claim 84, wherein the detection system comprises a plunger displacement sensor.

89. The system of claim 88, wherein the error comprises a volume of the medication injected into the live patient being inaccurate.

90. The system of claim 88, wherein the error comprises a rate of injection of the medication or an injection force exceeding a threshold.

91. The system of claim 88, wherein the error comprises the needle being in an artery of the live patient.

92. The system of claim 91, wherein the error of the needle being in the artery is detected by determining a relationship of a measured injection force or pressure and a measured rate of plunger displacement.

93. The system of claim 84, wherein the warning comprises audio, visual, or tactile feedback, or any combinations thereof

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0022] These and other features, aspects, and advantages of the present disclosure are described with reference to the drawings of certain embodiments, which are intended to schematically illustrate certain embodiments and not to limit the disclosure.

[0023] FIG. 1 is a simplified functional block diagram of an embodiment of the electronics assembly 100 of the smart syringe.

[0024] FIG. 2A illustrates an embodiment of a smart injection system with a data cap.

[0025] FIG. 2B illustrates a cross section of a proximal portion of the smart injection system of FIG. 2A.

[0026] FIG. 2C illustrates an example flowchart of displacement/rate of displacement measurement by an embodiment of a smart injection system.

[0027] FIG. 2D illustrates another embodiment of the smart injection system with a friction collar on a shaft of a smart stem.

[0028] FIG. 2E illustrates another embodiment of a smart injection system with a resistance wiper feature.

[0029] FIG. 3 illustrates stem pressure versus medication flow rate in tissue and in artery of any embodiment of a smart injection system.

[0030] FIG. 4A illustrates another embodiment of a smart injection system with features for monitoring location of an injection site relative to the patient's face.

[0031] FIG. 4B illustrates an example flowchart of location determination by an embodiment of a smart injection system.

[0032] FIG. 4C illustrates another embodiment of a smart injection system with features for monitoring location of an injection site relative to the patient's face.

[0033] FIG. 5 illustrates another embodiment of the smart injection system with the electronics integrated into a stem cap.

[0034] FIG. 6A illustrates an embodiment of a smart injection system with an identification device on a syringe and an identification device reader on a stem.

[0035] FIG. 6B illustrates an example flowchart of medication/syringe verification by the smart injection system of FIG. 6A.

[0036] FIG. 6C illustrates another embodiment of a smart injection system with an identification device on a syringe and an identification device reader on a stem.

[0037] FIG. 7 illustrates an example flowchart of injector verification by an embodiment of a smart injection system.

[0038] FIG. 8A illustrates an exploded view of another embodiment of a smart injection system with the electronics integrated in a syringe flange.

[0039] FIG. 8B illustrates a side view of the syringe flange of FIG. 8A.

[0040] FIG. 9 illustrates examples of integrating features of a smart injection system.

DETAILED DESCRIPTION

[0041] Although certain embodiments and examples are described below, those of skill in the art will appreciate that the disclosure extends beyond the specifically disclosed embodiments and/or uses and obvious modifications and equivalents thereof. Thus, it is intended that the scope of the disclosure herein disclosed should not be limited by any particular embodiments described below.

[0042] Some aspects of this present disclosure are directed to a smart injection system having smart features, that can, among other things, allow for measuring the location of the injection relative to the patient's face, guide the caregiver to the last injection site, measure the amount of medication injected into the patient and/or the speed and/or force of injection, authenticate medication to be injected in the patient, and verify identification of the injection provider.

Overview of Electronic Assembly

[0043] In some embodiments, a smart injection system includes a stem, a syringe, a needle, and an electronics assembly. The smart features of the injection system can be provided by interaction of the electronic assembly with at least one of the stem, syringe, needle assembly, or the patient. The smart injection system can wirelessly transmit measured data to a processing system that processes the data and to further transmit the data to one or more remote servers. FIG. 1 illustrates schematically an example electronics assembly 100 of a smart syringe. Physical locations and configurations of components of the electronics assembly 100 can vary and will be described in detail below.

[0044] As shown in FIG. 1, the electronics assembly 100 can include one or more sensors/readers 102, a processor 106, a wireless transceiver 108, and a power source (e.g., a battery) 110. The sensors/readers 102 that can be integrated into the electronic assembly are not limiting and can be any sensor or reader known in the art. Some examples include position sensor, force/pressure sensor, proximity/displacement sensor, biometric sensor, velocity sensor, resistance reader, barcode reader, EEPROM reader, or RFID tag reader. The position sensor can be accelerometer, gyroscope and magnetometer with three-degree angular and three-degree rotational resolution, and with a sensor drift adjustment capability (pitch, yaw and roll). The force sensor can be capable of sensing up to twenty pounds (20 lbs.) of force with a 2 percent accuracy factor. The proximity/displacement sensor can be optic range sensors or acoustic sensors. One example of an optic range sensor is a time-of-flight (ToF) camera system such as the FlightSense Ranging products (STMicroelectronics, Geneva Switzerland). One example of an acoustic range sensor is an ultrasonic sensor. A skilled artisan will appreciate that numerous other sensors and readers can be used in the disclosed electronics assembly 100 without departing from the scope of the disclosure herein. In some embodiments the electronics assembly 100 communicates data by way of a wireless transceiver 108 employing, for example, a Bluetooth wireless communications protocol. Other forms of wireless communication can also be used.

[0045] In some embodiments, the stem, syringe, and needle assembly of the smart injection system can be off-the-shelf or any standard injection systems, with the electronic assembly attached to one or more of the stem, syringe, and needle assembly before use. These embodiments can advantageously promote compatibility with most standard injection systems. The standard injection systems can be disposable, which can prevent cross-contamination due to re-use of any of the needle, syringe, or stem. In other embodiments, the stem 210, syringe 220, and needle assembly 230 can be custom-made to fit the electronic assembly 100. More details of these embodiments will be described below.

Data Cap with Force/Pressure Sensor

[0046] FIG. 2A illustrates a smart injection system 200 including the electronic assembly described above, a stem 210, a syringe 220, and a needle 230. In FIG. 2A, the stem 210, syringe 220, and needle 230 can be any standard injection systems with no built-in electronic components or smart features. The electronics assembly is attached to the standard injection system. For example, the electronic assembly can be built into a data cap 240, which can be coupled with a proximal cap 212 of the stem 210, making it a smart stem 210. The data cap 240 can be battery operated or rechargeable. One non-limiting example of coupling the data cap 240 and the proximal cap 212 of the stem 210 is a snap-fit feature. More detailed structures of the data cap 240 is shown in a cross sectional view of the injection system 200 in FIG. 2B. The data cap 240 can have an integrated cap 242 sliding over a cap body 244. The cap body 244 can have a slot 246 configured to accommodate the proximal cap 212 of the stem 210. A skilled artisan will appreciate that other means of coupling can be used, such as adhesives or clips. The electronic components, such as sensor(s)/reader(s), power source, and/or wireless transmitters can be built into an enclosed space formed by the integrated cap 242 and the cap body 244.

[0047] The data cap 240 can incorporate a printed circuit board (PCB) 250 having a force/pressure sensor. As illustrated in FIG. 2B, the PCB 250 can be located on a flat surface under a proximal end of the integrated cap 242 of the data cap 240. More specifically, the PCB 250, and therefore the force/pressure sensor is sandwiched between the flat surface of the integrated cap 242 and a column on the cap body 244. When the caregiver pushes the stem 210 distally along the syringe shaft 224 toward the needle 230, forces applied to the integrated cap 242 are transmitted to the proximal cap 212 via the force/pressure sensor and the column. The data cap 240 can optionally have a return spring 248 biased against an expanded configuration of the data cap 240 when no force is applied on the data cap 240. Pushing onto the data cap 240 can compress the return spring 248 and cause the data cap 240 to transit to a compressed configuration. The return spring 248 can advantageously maintain a minimum height of the enclosed space, preventing the electrical components inside the enclosed space from touching an inner surface of the cap body 244.

[0048] When a shaft 214 of the stem is positioned within a syringe shaft 224 and the caregiver pushes 252 onto the data cap 240, the stem shaft 214 is constrained to move distally and proximally along a longitudinal axis of the syringe shaft 224. The force/pressure sensor can measures a force or pressure applied to the data cap 240, which is the force or pressure applied to inject medication in the syringe 220. The force/pressure sensor can communicate the measured force/pressure information to, for example, an external processing system such as an interface/display device, by way of a communications protocol. In some embodiments the force/pressure sensor communicates data by way of the wireless transceiver 208 employing, for example, a Bluetooth wireless communications protocol. In some embodiments, the force/pressure sensor communicates data by way of a USB port using a cable that has a minimal diameter and is highly compliant.

[0049] In some embodiments, warnings can be given by the smart injection system 100, or the wireless transceiver 208 when the force/pressure measured by the force/pressure sensor exceeds or falls below a predetermined range. The form of warning is non-limiting, and can be audio, visual or tactile. By way of example, a beep or buzz can alert the caregiver and the patient of an inappropriate injection force/pressure. In another example, only a flashing LED light can go off or the smart injection system 200 can send a signal to, for example, a wristwatch worn by the caregiver, to provide tactile feedback. The visual and tactile alerts will only alert the caregiver so as to not agitate the patient during the injection procedure.

[0050] An ability of the smart injection system to measure the injection force/pressure can advantageously help in training the caregiver or medical personnel in providing a steady and desired injection force/pressure. A steady and appropriate injection force/pressure can reduce discomfort to the patient and ensure patient safety. Different medications may have different viscosity and require different ranges of injection force/pressure. The information about suitable ranges of injection force/pressure for various medications can be prepopulated in a processor of the wireless transceiver 208 before using the data cap 240. The information can also be encoded in a memory device included in the body of the syringe 220 during manufacturing and read by the data cap 240. For example, it can be in the form of an RFID tag, a bar code, a resistance value or encoded in an EPROM. In one embodiment, when the stem 210 and the data cap 240 coupled to the stem 210 are connected to the syringe 220, an electrical circuit can be completed such that the data cap 240 can communicate with any wired memory device on the syringe 220.

Data Cap with Displacement Sensor

[0051] With continued reference to FIGS. 2A-B, the data cap 240 can include a displacement sensor 260 as described herein. The displacement sensor 260 can be on a distal end of the data cap 240 such as when the data cap 240 is coupled to the proximal cap 212 of the stem 210, the displacement sensor 260 is at a distal side of the proximal cap 212. As shown in FIG. 2B, the displacement sensor 260 can be located on an outer surface of the cap body 244 of the data cap and directly faces a reflecting surface of a proximal syringe flange 222.

[0052] When the caregiver pushes onto the data cap 240, and therefore the proximal cap 212 of the stem 210, the displacement sensor 260 can detect axial travel/displacement of the stem shaft 212 within the syringe shaft 224. In some embodiments, the displacement sensor 260 detects a displacement of the stem shaft 212 with respect to time. As shown in FIG. 2C, the displacement sensor 260, such as the FlightSense sensor or an ultrasound sensor, can be activated 290 in any manner known in the art. For example, the sensor can be activated by charged or when the stem 210 connects to the syringe 220. The displacement sensor can be activated when the electronic assembly of the stem is charged. The activated displacement sensor 260 can send a signal 292 toward the proximal flange 222 of the syringe 220 and receive the signal 294 when the signal returns upon hitting a reflecting surface on the proximal flange 222 facing the displacement sensor 260. The displacement sensor 260 can measure and record 296 the time taken between sending and receiving the signal. The displacement sensor 260 can then communicate the measured data to a processor or the wireless transceiver 208 in the manner described herein. The processor can calculate an instantaneous displacement or rate of displacement of the stem 210 relative to the syringe 220 by taking into account the speed of light or sound as the displacement sensor 260 repeats the steps 292, 294, 296 to provide the processor with data measured with respect to subsequent signals. A skilled artisan will appreciate any types of optic range sensor or acoustic sensors can measure the displacement or rate of displacement of the stem 210 relative to the syringe 220.

[0053] Information about the displacement and/or the rate of displacement of the stem 210 can be valuable. For example, the information can be used to inform the medical personnel and/or the patient that the injection speed is too high or too low. In addition, as an inner cross sectional area of the syringe shaft 220 can be known, the displacement of the stem 210 inside the syringe shaft 224 can be used to calculate a volume of the medication being injected into the patient. In some embodiments, the information about the volume of injected medication can be available to the caregiver, patient, and or manufacturers of the medication real time. In some embodiments, the information can be automatically sent to the patient, manufacturer, medical professional, or a repository. This information can provide assurance to the patient that an appropriate amount of medication has been provided. The information can incentivize the caregiver to comply with injection procedure because detailed information about how the injection procedure is performed can be recorded and be part of the patient's medical record. The information also provides the medication manufacturers with a tool for inventory keeping and for predicting future sales. Current technology allows the manufacturers to only keep track of the amount of medication sold, but not of the amount of medication actually used.

[0054] Alternative embodiments of the injection system capable of measuring displacement and/or displacement rate of the stem 210 relative to the syringe 220 will now be described. FIG. 2D illustrates an optional friction slide collar 270, which can have a surface with reflective property facing the proximal cap 212 of the stem. This surface can function as a reflecting surface instead of the syringe flange 222. The collar can move axially along the stem shaft 214 and can advantageously provide more fine-tuned resolution for axial displacement or rate of displacement of the stem 210 relative to the syringe 220 as the collar does not move or wobble when the stem 210 is moved axially into the syringe.

[0055] FIG. 2E illustrates another method of measuring displacement and/or displacement rate of the stem 210 relative to the syringe 220. In this embodiment, the syringe 220 has a spring wiper 226 at or near a proximal end of the syringe 220. For example, the wiper 226 can be located right above the syringe flange 222. The stem shaft 214 has a strip of variable resistor 216 along a longitudinal axis of the stem shaft 214. The resistor 216 can be electrically wired to the wireless communication components on the stem 210 and can provide measured resistance values to the wireless transceiver 208. The measured resistance values can inform on the axial displacement or displacement rate of the stem 210 relative to the syringe 220. Further, any combination of the above-described displacement sensors can be used in a single device.

Data Cap with Force/Pressure and Displacement Sensors

[0056] Turning to FIG. 3, a method of an embodiment of a smart injection system having both a force/pressure sensor and a displacement sensor disclosed herein will now be described. A risk during an injection procedure is when the needle hits an artery, because the medication injected can lead to artery occlusion, and can potentially cause blindness in the patient. One or more processors, such as one on a remote server, in communication with the smart injection system or included as part of the smart injection system, can process measured data from included sensors. For example, the one or more processors can analyze pressure applied to the stem in relation to a mediation flow rate. The flow rate can be calculated from the displacement rate data as described above. The relationships of the pressure applied on the stem and the medication flow rate when the needle is placed in the tissue and inside an artery are illustrated in FIG. 3. The processor can analyze the medication flow rate when the pressure measured by the force/pressure sensor is within a nominal range. As shown in FIG. 3, the flow rate is significantly higher in the artery than in the tissue for the same range of nominal pressure because blood has less resistance than tissues.

[0057] Using this information, the processor can output a warning in any manner as described herein when the flow rate during the nominal range of measured pressure indicated that the current injection site is an artery instead of tissue. This will warn a physician to stop the injection immediately and can provide immediate instructions for applying a dissolving agent. The immediate alert can also allow the physician to leave the needle in place and swap the currently injected substance for a dissolving agent without changing the injection site. In some embodiments, when the needle is still inside the artery, the syringe containing the medication can be replaced with a syringe containing a clot-dissolving agent. A non-limiting example of a clot-dissolving agent is hyaluronidase.

Data Cap with Angular & Relative Positioning

[0058] Returning to FIGS. 2A-B, the data cap 240 can include 3-axis gyroscope, 3-axis accelerometer, and 3-axis magnetometer (a 9-axis Inertia Motion Sensor (IMS)) as described herein. The 9-axis IMS can measure angular position and rotation of the data cap 240, and therefore of the proximal cap 212 of the stem 210. As shown in FIG. 2B, the 9-axis IMS can be located on the PCB 250, although a skilled artisan will recognize that the 9-axis IMS can be located in any appropriate part of the data cap 240.

[0059] Methods of using a smart injection system 400 having a 9-axis IMS for locating approved and/or prohibited injection zone(s) will be described with reference to FIGS. 4A-C. As shown in FIG. 4A, two landmarks 401, 402 on a patient's face can be provided on a pair of glasses and a third landmark 403 can be identified provided a bite block on a patient's mouth to define a patient's face. A skilled artisan will appreciate that any suitable landmarks of any combination can be used to define the patient's face. In some embodiments, additional or secondary landmarks can be provided on the patient's face, such as by a marker pen, stickers (shown in FIG. 4B) and/or face masks. These additional landmarks can be used instead of or in combination with the three landmarks 401, 402, 403 or other suitable landmarks. Information about the landmarks 401, 402, 403 and other landmarks can be preloaded on a processor in communication with the smart injection system 200. The 9-axis IMS can communicate with the wireless transceiver 408 in any manner described above to provide angular and rotational position of a stem 410 coupled to a syringe 420 and a needle 430.

[0060] As shown in FIG. 4C, the processor can receive 490 data measured by the 9-axis IMS from the wireless transceiver 408 and compare 492 the measured data with the preloaded landmarks information in order to calculate the location and position of the injection system 400 relative to the patient's face. The processor can check 494 if the location is in an approved injection zone. If the injection system is in an approved zone, the processor can output an indication 495 that the caregiver can proceed with the injection at the current location and position of the injection system. If the injection system is not in an approved zone, the processor can check 496 if the injection system is in a no-injection zone. If the injection system is in a no-injection zone, the processor can output a warning 497 in any manner described herein. If the injection is in neither an approved nor a no-inject zone, the processor can output an instruction 498 to the caregiver to move the injection system.

[0061] In some embodiments, the processor can output an indication of the relative position of the injection system 400 to the patient's face by green and red LED lights. For example, a green light indicates that the injection system 400 is targeting an approved injection zone 405 and a red light indicates that the injection system 400 is targeting a no-inject zone 407. In another example, the processor can display the position of the injection system 400 relative to the patient's face on a display screen. Details of the display systems and methods are described in U.S. Provisional Application No. 62/303,251, filed Mar. 3, 2016 and entitled GUIDED NEEDLE, the entirety of which is incorporated by reference herein and should be considered a part of this disclosure.

Integrated Smart Stem

[0062] Turning to FIG. 5, another embodiment of a smart injection system 500 will be described. The injection system 500 has the same features as the injection system 200, 400 except as described below. Accordingly, features of the injection system 200, 400 can be incorporated into features of the injection system 500 and features of the injection system 500 can be incorporated into features of the injection system 200, 400. The smart injection system 500 also has a stem 510, a syringe 520, and a needle 530. The syringe 520 and needle 530 may be standard off-the-shelf syringe and needle and be disposable. However, the stem 510 includes one or more electronic components as described above that are integrated into a proximal cap 512 of the stem 510. The stem 510 can be battery operated or rechargeable. Examples of the electronic components include but are not limited to force/pressure sensor, displacement sensor, 9-axis IMS, biometric sensor, power source and wireless transmitters. In this embodiment, the stem 510 is designed to be reusable. For example, some electronic components can be sealed within the proximal cap 512 so that the stem 510 can be sterilized without affecting those electronic components or any exposed sensors/readers can be directly sterilized. A skilled artisan will recognize that any method of using the injection system having the data cap 240 can be performed by the injection system 500 with the integrated proximal cap 512.

Smart Injection System with Medication Verification

[0063] Turning to FIG. 6A, a smart injection system 600 capable of verifying authenticity of a syringe containing certain medications will be described. The injection system 600 has the same features as the injection system 200, 400, 500 except as described below. Accordingly, features of the injection system 200, 400, 500 can be incorporated into features of the injection system 600 and features of the injection system 600 can be incorporated into features of the injection system 200, 400, 500.

[0064] In this embodiment, the syringe 620 can have a manufacturer's identification device 625 on the syringe shaft 624. The manufacturer's identification device 625 can be one or more of an EEPROM, a barcode, a RFID tag, or a resistor. The identification device 625 can be embedded in a wall of the syringe shaft 620, located on an inner or outer surface of the syringe shaft 624, or located at a top lip of the shaft, for example, as shown in FIG. 6C. Exact location of the identification device 625 on the syringe 220 is not limiting. The stem 610 has a corresponding identification device reader 615 on the stem shaft 614. For example, the corresponding identification device reader 615 can be an EEPROM reader, a bar code reader, an RFID tag reader or a resistance reader.

[0065] When an authentic syringe 620 prefilled with medication by the manufacturer is used with the stem 610, the identification device reader 615 on the stem 610 will interact with or read the identification device 625 on the syringe 620. For example, an RFID tag as the identification device 625 can be encoded by the manufacturer so that only an authentic prefilled syringe 620 will result in a positive reading. The identification device reader 615 on the stem 610 can be electrically wired to the wireless transmitter on the stem 210 and can provide a reading result to a wireless transceiver, which can forward the data to one or more remote servers. The injection system 600 or the wireless transceiver can provide a warning or indication of authenticity in any manner described above. The manufacturer can access information sent to the remote server receive to be informed when its medication is used and be alerted when a counterfeit prefilled syringe is detected by the stem 610.

[0066] In some embodiments, the identification device 625 can store information related to authenticity or product type, as well as optionally store information specific about the particular batch of medication or the syringe. Non-limiting examples of such information include serial and/or lot number, expiration date of the medication, and prior use of the syringe 620. Serial/Lot numbers can provide easy identification of the manufacturer and aid the manufacturer in keeping track of medication that has been injected into patients. Expiration date of the medication can ensure that patients are not injected with expired or unsafe products. Information about prior use of the syringe 620 can inform the caregiver and/or the patient that the medication in the syringe may have been tampered with and prevent cross-contamination caused by multiple uses of the syringe 620. The information can also be used for tracking inventory and aiding in product recalls.

[0067] FIG. 6B illustrates a flowchart of processing activities of one or more processors. The processor first determines from the data sent by the identification device reader 615 if an identification device is present on the syringe 620 in step 690. In some embodiments, the identification device reader is powered by the electronic assembly of the injection system. In some embodiments, if no identification device is present, the processor will deactivate any sensors or readers on the electronic assembly so that no data about the counterfeit product is collected in step 691. The processor can also alert the patient, caregiver, and/or the manufacturer about counterfeit products in the step 691. In an embodiment, sensors can continue to operate, but the data is not provided to the physician. It can be kept for later analysis by the manufacturer. In other embodiments, only an alert is provided, but the processor and sensors continue to operate as normal. If an identification device is present and can be read, the processor can optionally decode 692 any encoded information on the identification device. Once the information has been decoded, the processor can access a manufacturer's database 693 containing information about its prefilled syringes to compare the decoded information with information on the database. If there is a match between the data on the syringe and information on the database, the processor can output for display 694 the information about the prefilled syringe, such as the manufacturer information, serial and lot numbers, product types, instructions for use, indications, etc., and output an indication that the prefilled syringe is an authentic product. If there is no match, the processor can repeat the warning step 691. The processor can optionally further determine if the medication has expired based on its date of production 695, or if the syringe has been previously used 696, which suggests that the syringe and the medication in the syringe has been tampered with. The processor can then output either an indication that the prefilled syringe is safe for use 694 or a warning 691 accordingly.

Smart Stem with Injector Verification

[0068] In some embodiments, the smart injection system described herein can optionally include a biometric sensor. The biometric sensor can be included on the data cap 240, for example, on the PCB 250, or on the integrated proximal cap 512 of the stem 510. A non-limiting example of biometric sensors is a fingerprint reader, although a skilled artisan will recognize that other biometric sensors known in the art can be used. The biometric sensor can detect information about the person performing the injection procedure. The biometric sensor can transmit measured data about the person performing the injection procedure to the wireless transceiver 208, 508, which can in turn send the measured data to a processor in communication with the wireless transceiver. In some embodiments, the processor can be on a remote server, which can also store or have access to a database of qualified personnel.

[0069] As shown in FIG. 7, the processor can first determine if any data is read 790 by the biometric sensor after the smart injection system has been activated. The processor can output a warning 792 if the biometric sensor cannot read any data and/or stop all measuring activities as described herein. In some embodiments, the processor can also deactivate all sensors of the electronic assembly so that no data about the injection procedure is measured in the warning step 792. In some embodiments, the warning step 792 can further include a warning to the medical certification board that the clinic or hospital where the injection took place is likely allowing unqualified personnel to perform the injection. If biometric data about the injector is received, the processor compares it with the database of qualified personnel 794 to look for a match. If the data collected about the person performing the injection does not match one in the database, the processor can repeat the alert step 792 described herein. If there is a match, the processor can output an indication that the injector is qualified to perform the injection 796. Collecting data about the caregiver can deter clinics/hospitals from hiring untrained staff to perform the injections, thereby improving safety of the patients and accountability of the medical professionals.

Integrated Syringe Flange

[0070] Turning to FIGS. 8A-B, another embodiment of a smart injection system 800 will be described. The injection system 800 has the same features as the injection system 200, 400, 500, 600, except as described below. Accordingly, features of the injection system 200, 400, 500, 600, can be incorporated into features of the injection system 800 and features of the injection system 800 can be incorporated into features of the injection system 200, 400, 500, 600. The smart injection system 800 has a stem 810, a flange 822, and a syringe 820 with a syringe lip 823 and a syringe shaft 824. A needle can be coupled to the syringe shaft 824 at a distal end of the syringe shaft 824.

[0071] FIG. 8A-8B illustrate an example mechanism for removably coupling the flange 822 to the syringe 820. As shown, the flange 822 has a slot 827 sized to fit the syringe lip 823. Sliding the syringe lip 823 into the slot 827 allows the flange 822 to be attached to the syringe 820. A skilled artisan will recognize that other means of coupling the flange 822 to the syringe 820 known in the art, for example, clips, adhesives, and the like, can be used without departing from the scope of the disclosure herein.

[0072] The stem 810 and the syringe 820 may be standard off-the-shelf parts, and be disposable. The flange 822 includes one or more electronic components as described above that are integrated into the flange 822 and is designed to be reusable. In this embodiment, for example, some electronic components can be sealed within the flange 822 so that the flange 822 can be sterilized without affecting those electronic components or any exposed sensors/readers can be directly sterilized.

[0073] Examples of the electronic components include but are not limited to a velocity sensor, a 9-axis IMS, biometric sensor, an identification device reader, a power source (for example, disposable or rechargeable batteries), and wireless transmitters. For example, the velocity sensor can be any velocity sensor known in the art and can measure the displacement and/or rate of displacement of the stem 810 relative to the syringe 820. Information about the speed of injection and volume of medication injected into the patient can be determined with the data measured by the velocity sensor as described above. In addition, the injection pressure can be calculated based on the measured data and known constants, including but not limited to viscosity and drag. A skilled artisan will recognize that the velocity sensor can be implemented in the data cap 240 and/or the integrated stem 510. A skilled artisan will also recognize that any method of using the injection system having the data cap 240 or the integrated stem proximal cap 512 can be performed by the injection system 800 with the integrated flange 822. It is to be understood that only one, more than one, or all of the above listed sensors and other sensors known in the art can be integrated into and used with flange 822.

[0074] In some embodiments, an identification device 825 as described above can be placed on the syringe lip 823, as shown in FIG. 8A. When the flange 822 connects to the syringe lip 823, an identification device reader 826 on the flange 823 can read the information on the identification device 825 in any manner described herein and perform verification of the medication prefilled in the syringe 820 and/or the syringe 820.

Combination and/or Subcombination Embodiments

[0075] Although features of the smart injection system are described individually in various embodiments herein, a skilled artisan will appreciate that any one or more of those features described herein can be implemented on a smart injection system.

[0076] An example combination of features and the advantages thereof are illustrated in FIG. 9. The injection system can have an electronic assembly configured to measure a variety of information, including but not limited to force of injection and/or travel of the stem information, angular and relative position of the stem relative to a patient's face, verify authenticity and other product information of a prefilled syringe, and verify identity of an injector, in the manners described above. The information measured by the electronic assembly can be transmitted to one or more processors located locally or remotely. In some embodiments, the measured data can cause the one or more processors to generate local alerts/alarms on the injection system or in the room where the patient receives the injection. In some embodiments, data transmission can be performed wirelessly and the one or more processors can be located on one or more remote servers (the Cloud). In response to the measured data, the processor can output instructions to the injection system. Examples of the instructions include information about whether the injector is an authorized/licensed medical professional, whether the procedure is in compliance with protocols, whether the medication being injected is safe and/or authentic, and the like. In response to the measured data, the processor can also output alerts and/or data to the manufacturer, including but not limited to information about medication usage for inventory control, monitoring of injectors' qualification, and injection quality data. In some embodiments, the processor can make the alerts and/or data available for retrieval by the manufacturer. In other embodiments, the processor can automatically send the alerts and/or data to the manufacturer.

[0077] In addition, an augment to the alarms/alerts on the injection system can provide audio, visual or tactile feedback confirming the correct injection technique. This continuous feedback contributes to a more perfect injection than threshold alarms that are triggered only at the limits of acceptable operation.

[0078] It is to be understood that the various sensor and electronics, as well as the techniques and processes described with respect to each embodiment disclosed herein can be used with and integrated to other embodiments disclosed herein as would be readily understood by a person of skill in the art reading the present disclosure.

Terminology

[0079] Conditional language used herein, such as, among others, can, could, might, may, e.g., and the like, unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to convey that certain embodiments include, while other embodiments do not include, certain features, elements and/or steps. Thus, such conditional language is not generally intended to imply that features, elements and/or steps are in any way required for one or more embodiments or that one or more embodiments necessarily include logic for deciding, with or without other input or prompting, whether these features, elements and/or steps are included or are to be performed in any particular embodiment. The terms comprising, including, having, and the like are synonymous and are used inclusively, in an open-ended fashion, and do not exclude additional elements, features, acts, operations, and so forth. Also, the term or is used in its inclusive sense (and not in its exclusive sense) so that when used, for example, to connect a list of elements, the term or means one, some, or all of the elements in the list.

[0080] Conjunctive language such as the phrase at least one of X, Y, and Z, unless specifically stated otherwise, is otherwise understood with the context as used in general to convey that an item, term, etc. may be either X, Y, or Z. Thus, such conjunctive language is not generally intended to imply that certain embodiments require the presence of at least one of X, at least one of Y, and at least one of Z.

[0081] Language of degree used herein, such as the terms approximately, about, generally, and substantially as used herein represent a value, amount, or characteristic close to the stated value, amount, or characteristic that still performs a desired function or achieves a desired result. For example, the terms approximately, about, generally, and substantially may refer to an amount that is within less than 10% of, within less than 5% of, within less than 1% of, within less than 0.1% of, and within less than 0.01% of the stated amount. As another example, in certain embodiments, the terms generally parallel and substantially parallel refer to a value, amount, or characteristic that departs from exactly parallel by less than or equal to 15 degrees, 10 degrees, 5 degrees, 3 degrees, 1 degree, 0.1 degree, or otherwise.

[0082] Any methods disclosed herein need not be performed in the order recited. The methods disclosed herein include certain actions taken by a practitioner; however, they can also include any third-party instruction of those actions, either expressly or by implication. For example, actions such as inserting the testing tool include instructing insertion of a testing tool.

[0083] All of the methods and tasks described herein may be performed and fully automated by a computer system. The computer system may, in some cases, include multiple distinct computers or computing devices (e.g., physical servers, workstations, storage arrays, cloud computing resources, etc.) that communicate and interoperate over a network to perform the described functions. Each such computing device typically includes a processor (or multiple processors) that executes program instructions or modules stored in a memory or other non-transitory computer-readable storage medium or device (e.g., solid state storage devices, disk drives, etc.). The various functions disclosed herein may be embodied in such program instructions, and/or may be implemented in application-specific circuitry (e.g., ASICs or FPGAs) of the computer system. Where the computer system includes multiple computing devices, these devices may, but need not, be co-located. The results of the disclosed methods and tasks may be persistently stored by transforming physical storage devices, such as solid state memory chips and/or magnetic disks, into a different state. In some embodiments, the computer system may be a cloud-based computing system whose processing resources are shared by multiple distinct business entities or other users.

[0084] Depending on the embodiment, certain acts, events, or functions of any of the processes or algorithms described herein can be performed in a different sequence, can be added, merged, or left out altogether (e.g., not all described operations or events are necessary for the practice of the algorithm). Moreover, in certain embodiments, operations or events can be performed concurrently, e.g., through multi-threaded processing, interrupt processing, or multiple processors or processor cores or on other parallel architectures, rather than sequentially.

[0085] The various illustrative logical blocks, modules, routines, and algorithm steps described in connection with the embodiments disclosed herein can be implemented as electronic hardware (e.g., ASICs or FPGA devices), computer software that runs on general purpose computer hardware, or combinations of both. Various illustrative components, blocks, and steps have been described above generally in terms of their functionality. Whether such functionality is implemented as specialized hardware versus software running on general-purpose hardware depends upon the particular application and design constraints imposed on the overall system. The described functionality can be implemented in varying ways for each particular application, but such implementation decisions should not be interpreted as causing a departure from the scope of the disclosure.

[0086] Moreover, the various illustrative logical blocks and modules described in connection with the embodiments disclosed herein can be implemented or performed by a machine, such as a general purpose processor device, a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field programmable gate array (FPGA) or other programmable logic device, discrete gate or transistor logic, discrete hardware components, or any combination thereof designed to perform the functions described herein. A general purpose processor device can be a microprocessor, but in the alternative, the processor device can be a controller, microcontroller, or state machine, combinations of the same, or the like. A processor device can include electrical circuitry configured to process computer-executable instructions. In another embodiment, a processor device includes an FPGA or other programmable device that performs logic operations without processing computer-executable instructions. A processor device can also be implemented as a combination of computing devices, e.g., a combination of a DSP and a microprocessor, a plurality of microprocessors, one or more microprocessors in conjunction with a DSP core, or any other such configuration. Although described herein primarily with respect to digital technology, a processor device may also include primarily analog components. For example, some or all of the rendering techniques described herein may be implemented in analog circuitry or mixed analog and digital circuitry. A computing environment can include any type of computer system, including, but not limited to, a computer system based on a microprocessor, a mainframe computer, a digital signal processor, a portable computing device, a device controller, or a computational engine within an appliance, to name a few.

[0087] The elements of a method, process, routine, or algorithm described in connection with the embodiments disclosed herein can be embodied directly in hardware, in a software module executed by a processor device, or in a combination of the two. A software module can reside in RAM memory, flash memory, ROM memory, EPROM memory, EEPROM memory, registers, hard disk, a removable disk, a CD-ROM, or any other form of a non-transitory computer-readable storage medium. An exemplary storage medium can be coupled to the processor device such that the processor device can read information from, and write information to, the storage medium. In the alternative, the storage medium can be integral to the processor device. The processor device and the storage medium can reside in an ASIC. The ASIC can reside in a user terminal. In the alternative, the processor device and the storage medium can reside as discrete components in a user terminal.

[0088] While the above detailed description has shown, described, and pointed out novel features as applied to various embodiments, it can be understood that various omissions, substitutions, and changes in the form and details of the devices or algorithms illustrated can be made without departing from the spirit of the disclosure. As can be recognized, certain embodiments described herein can be embodied within a form that does not provide all of the features and benefits set forth herein, as some features can be used or practiced separately from others. The scope of certain embodiments disclosed herein is indicated by the appended claims rather than by the foregoing description. All changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope.