System for collecting injection information

Abstract

To provide an injection system for managing injection related information.SOLUTION: A system for measuring injection of a liquid medicine includes a syringe body having proximal and distal ends, a syringe interior, and a syringe flange at the proximal end thereof. The system also includes a stopper member disposed in the syringe interior. The system further includes a plunger member coupled to the stopper member and configured to be manipulated to insert the stopper member distally in the syringe interior relative to the syringe body. Moreover, the system includes a needle coupled to the syringe body at the distal end thereof. In addition, the system includes a sensor flange removably coupled to the syringe body. The sensor flange includes a sensor to measure an injection characteristic and a processor to analyze the injection characteristic to determine an occurrence of an injection event.SELECTED DRAWING: Figure 6

Description

[Technical field]

[0001]

[0001] This application relates generally to injection systems, devices, and processes for achieving various levels of control over fluid injections, and more particularly to systems and methods relating to safety syringes in medical environments. Even more particularly, this application relates to injection systems, devices, and processes for managing injection-related information. [Background technology]

[0002]

[0002] Millions of syringes (2), as shown in FIG. 1A, are consumed daily in medical environments. A typical syringe (2) includes a tubular body (4), a plunger (6), and an injection needle (8). As shown in FIG. 1B, such syringes (2) can be utilized not only to inject liquids into patients, but also to withdraw or insert liquids from containers such as vials, bags, or other drug containment systems (10). In fact, due to regulatory constraints and concerns about maintaining sterility in some countries, such as the United States, when using a syringe (2) with a drug bottle (10), as shown in certain patient environments, the drug bottle must be used with one patient and then discarded, resulting in a large amount of medical waste of bottles and waste of remaining medicine, and also causing periodic shortages of certain important drugs.

[0003]

[0003] Referring to Figure 2A, three luer type syringes (12) are shown, each with a distally disposed luer fitting structure (14) that can be mated with other devices having a similar mating configuration, such as the luer manifold assembly (16) shown in Figure 2B. The luer manifold assembly of Figure 2B can be used to administer fluids intravenously to a patient with or without an intravenous fluid bag. The luer fittings (14) of the syringes in Figure 2A are referred to as "male" luer fittings, and the luer fittings in Figure 2B (18) are referred to as "female" luer fittings. One of the luer type interfaces can be threaded (in which case this configuration is referred to as a "luer lock" configuration), allowing the two to be mated by relative rotation, and may be combined with a compressive load. In other words, one embodiment of a luer lock may utilize rotation, possibly along with compression, to engage threads within a male fitting (14) that are configured to engage a flange of a female fitting (18) to together provide a fluid-tight connection to the device. Another embodiment may utilize a tapered interface shape to provide a luer engagement using compression without threads or rotation (such an arrangement may be referred to as a "slip-on" or "conical" luer arrangement). While such luer connections are considered relatively safe for the operator, there is a risk of spillage or leakage of medication or damage to parts during assembly of the luer connection.

[0004]

[0004] However, the use of needle injection configurations carries with it the risk of a sharp needle contacting or piercing an unwanted person or structure. For this reason, so-called "safety syringes" have been developed. One embodiment of a safety syringe (20) is shown in FIG. 3, in which a tubular shield member (22) is spring-biased to cover the needle (8) when released from a locked position relative to the syringe body (4). Another embodiment of a safety syringe (24) is shown in FIGS. 4A-4B. In such a configuration, after the plunger (6) is fully inserted relative to the syringe body (4), the retractable needle (26) is retracted (28, 26) back to a safe position within the tubular body (4), as shown in FIG. 4B. Such a configuration configured to collapse on itself may be associated with issues of blood splashing / aerosolization, safe storage of preload energy that may result in malfunction or premature activation, reduced accuracy of full dose injection due to dead space remaining within the compressed volume of the spring, and / or loss of pullback speed control resulting in pain and patient anxiety.

[0005] Further complicating the syringe market is the increasing demand for pre-filled syringe assemblies, as shown in Figures 5A and 5B. A syringe assembly generally comprises a syringe body, or "drug enclosure delivery system" (34), a plunger tip, a plug or stopper (36), and a distal seal or cap (35) that may be attached to a luer type interface (Figure 5A shows the cap 35 in place, while Figure 5B shows the cap removed to show the luer interface (14)). The drug solution resides in a volume or drug reservoir (40) between the distal seal (35) and the distal end (37) of the plunger tip (36). The plunger tip (36) comprises a standard butyl rubber material and is coated with a biocompatible lubricous coating, such as polytetrafluoroethylene ("PTFE"), to provide favorable sealing and relative motion characteristics for the associated syringe body (34) structure and material. The proximal end of the syringe body (34) of FIG. 5B has a conventional integral syringe flange (38) formed integrally with the material of the syringe body (34). The flange (38) is configured to extend radially from the syringe body (34) and may be configured to be a full or partial circumference around the syringe body (34). The partial flange is called a "clip flange" and the other is called a "full flange." The flange is used to grip the syringe with the fingers and provide support for depressing the plunger to inject. The syringe body (34) preferably has a translucent material such as glass or polymer. A plunger tip (36) may be positioned within the syringe body (34) to form a containment volume within a chamber or reservoir (40) and aid in the ejection of associated fluid through the needle. The syringe body (34) may define a substantially cylindrical shape (so that a plunger tip 36 having a circular cross-sectional shape may establish a seal with the syringe body) or may be configured to have other cross-sectional shapes, such as an ellipse.

[0006]

[0006] Such assemblies are desirable because they are standardized and produced in precise volumes by a small number of manufacturers worldwide who have the capacity to meet all of the world's ever-changing regulations regarding filling, packaging, and drug / drug interface material selection and component use. However, such simple configurations do not usually meet new global standards for disposability, safety, auto-disable, and needlestick protection. Certain suppliers are therefore moving to more "vertical" solutions, such as the system (41) shown in FIG. 5C, which attempt to meet all or at least some of the standards in one solution. Attempting to meet these standards in many different settings results in such products having significant limitations (including some of those discussed above with reference to FIGS. 3-4B) and relatively large inventory and usage costs.

[0007] Regardless of the type of injection system, collecting information related to the delivery of an injectable (e.g., medication) provides many advantages. In embodiments in which the injectable medication is self-administered by the patient, collecting information related to the delivery of the injectable medication (i.e., "injection information") can facilitate determining patient compliance. In such embodiments, the injection information can be whether an injection was administered. Because patient non-compliance increases healthcare costs, determining patient compliance can reduce healthcare costs and improve healthcare outcomes. Even in embodiments in which the injectable medication is administered by a healthcare professional, collecting injection information can increase the accuracy of tracking the injectable medication delivery, thereby reducing healthcare costs and improving healthcare outcomes (e.g., by determining whether an injection was properly delivered). By automating the collection of injection information, these advantages and many others can be obtained with minimal or no human intervention.

[0008]

[0008] Automated collection of injection information will lead to advancements in various medical fields, including but not limited to medical informatics, personalized medicine, electronic medical records, and personalization of wearable computing devices. Collected injection information can be used to assist in the management and scheduling of delivery of injectable medications. Collected injection information can also be transmitted to third parties (e.g., healthcare providers, insurance companies, etc.) to improve healthcare management and personalization.

[0009]

[0009] There is a need for an injection system that addresses the shortcomings of currently available designs. In particular, there is a need for an injection system that can automatically collect injection information while utilizing the existing, relatively well-controlled supply chain of conventionally provided syringes and cartridges. Furthermore, there is a need for an injection system that can communicate with various stakeholders (e.g., patients, healthcare providers, insurance companies, etc.) based on the collected injection information to improve healthcare outcomes and reduce healthcare costs. Summary of the Invention

[0010]

[0010] Embodiments relate to injection systems, and more particularly, to a safety injection system that transitions a needle into a protective configuration to minimize accidental user injury and contamination from used needles.

[0011] In one embodiment, an injection system includes a syringe body having a proximal end and a distal end, a syringe interior, and a syringe flange at the proximal end. The system also includes a stopper member disposed within the syringe interior. The system further includes a plunger member coupled to the stopper member and configured to be manipulated to distally insert the stopper member relative to the syringe body within the syringe interior. Additionally, the system includes a needle coupled to the syringe body at its distal end. Additionally, the system includes a sensor flange removably coupled to the syringe body at least partially distal to the syringe flange. The sensor flange includes a first sensor and a second sensor for measuring respective first and second injection characteristics. The sensor flange also includes a processor that analyzes the first and second injection characteristics to monitor an injection event.

[0012]

[0012] A preferred embodiment of the sensor flange is one that is utilized with a syringe that is pre-filled with medication by the manufacturer. Alternatively, the sensor flange can be used with a syringe that is filled by the user prior to administering an injection. In either case, the sensor flange is pre-installed on the syringe or attached to the syringe at the time of injection. Additionally, the electronics and sensor of the sensor flange can be located in or on the plunger rod.

[0013]

[0013] In one or more embodiments, the first sensor is a force sensor, the first injection characteristic is an injection back pressure, and the second sensor is a motion sensor, and the second injection characteristic is a movement of the plunger member. The injection event may be an ejection to atmosphere. The sensor flange may include an orientation sensor that measures an orientation, and the processor analyzes the orientation to confirm the ejection to atmosphere. The injection event may be a needle blockage. The injection event may be a leak in the injection system.

[0014] In one or more embodiments, the sensor flange is configured to be manipulated relative to the syringe body to distally insert the stopper member into the syringe interior, and the plunger member includes a proximal end pad that is manipulated simultaneously with the sensor flange to distally insert the stopper member into the syringe interior relative to the syringe body.

[0015] In one or more embodiments, the sensor flange also includes an attachment sensor for detecting when the sensor flange is removably coupled to the syringe body. The attachment sensor may include a mechanical switch.

[0016]

[0016] In one or more embodiments, the first and second sensors are selected from the group consisting of an acoustic sensor, a motion sensor, a proximity sensor, a temperature sensor, a force sensor, an accelerometer sensor, an orientation sensor, and an optical sensor. The motion sensor may measure a position, a velocity, or an acceleration of the plunger member. The motion sensor may be an optical sensor. The optical sensor may be an IR sensor. The plunger member may include an identifier that is read by the optical sensor. The identifier may include data selected from the group consisting of a drug name, a drug dosage, a serial number, and an expiration date. The motion sensor may be a laser motion sensor. The acoustic sensor may include an ultrasonic transducer.

[0017] In one or more embodiments, the temperature sensor may measure the temperature of the injectable substance in the syringe. The processor may calculate an approximate time for the injectable substance to reach an injection temperature based at least in part on the measured temperature. The sensor flange may also include an output device that transmits an alarm signal when the measured temperature reaches an injection temperature.

[0018]

[0018] In one or more embodiments, the sensor flange also includes a battery. The sensor flange may also include a memory module. The sensor flange may also include a wireless communication device. The wireless communication device may be a Bluetooth communication device, a WiFi communication device, a WiFi Direct communication device, and / or a cellular communication device.

[0019] In one or more embodiments, the sensor flange is configured to receive injection configuration data via the wireless communication device, which may include data selected from the group consisting of current date and time, first injection date and time, injection frequency, syringe type, viscosity, temperature, warming time, maximum shear force, multiple injection site regimen data, rewards program data, and education / marketing data.

[0020] In one or more embodiments, the sensor flange is configured to transmit post-injection data to a computing device via a wireless communication device. The post-injection data may include data selected from the group consisting of injection date and time, injection frequency, plunger force, injection elapsed time, injection error related data, viscosity, temperature, warming time, shear force, residual drug in the syringe, multiple injection site regimen data, rewards program data, and education / marketing data. The injection error may be selected from the group consisting of drug identification error, injection timing error, dosage error, shear force error, degassing error, residual drug remaining in the syringe, and multiple site injection error.

[0021] In one or more embodiments, the sensor flange also includes an output device. The output device may be a speaker. The output device may be a light source. The output device may be a display device.

[0022] In one or more embodiments, the sensor flange also includes a clock. The sensor flange may also include an output device that transmits an alarm signal. The alarm signal is delivered when an injection is due. The alarm signal may be an audible alarm signal. The alarm signal may be a visual alarm signal.

[0023]

[0023] An alarm signal may be delivered until the sensor flange is coupled to the syringe body. An alarm signal may be delivered when the sensor flange detects an injection error. The injection error may be selected from the group consisting of a drug identification error, an injection timing error, a dosage error, a shear force error, a degassing error, residual drug remaining in the syringe, and a multiple site injection error. An alarm signal may be delivered if the sensor flange is not removed from the syringe body within a predetermined time after the injection is completed.

[0024] In one or more embodiments, the sensor flange is configured to slide along the longitudinal axis of the syringe body when the sensor flange is removably coupled to the syringe body.

[0025] In another embodiment, a method of collecting information regarding an injection includes removably coupling a sensor flange to a syringe body of an injection system. The injection system includes a syringe body having a proximal end and a distal end, a syringe interior, and a syringe flange at the proximal end. The system also includes a stopper member disposed within the syringe interior. The system further includes a plunger member coupled to the stopper member. The system further includes a needle coupled to the syringe body at its distal end. The method also includes manipulating the plunger member to insert the stopper member distally into the syringe interior relative to the syringe body to perform the injection. The method further includes measuring first and second injection characteristics, respectively, using the sensor flange. The method further includes analyzing the first and second injection characteristics to monitor the injection event. The sensor flange is removably coupled to the syringe body at least partially distal to the syringe flange.

[0026]

[0026] In one or more embodiments, the sensor flange includes a clock, an output device, a wireless communication device, a memory module, first and second sensors, and a processor. Measuring the first and second injection characteristics using the sensor flange includes a first sensor measuring the first injection characteristic and a second sensor measuring the second injection characteristic. The first sensor may be a force sensor, and the first injection characteristic may be an injection backpressure. The second sensor may be a motion sensor, and the second injection characteristic may be a movement of the plunger member. The injection event may be an ejection to atmosphere, and the method also includes detecting the ejection to atmosphere when the injection backpressure is substantially zero and the movement of the plunger member is non-zero.

[0027] In one or more embodiments, the sensor flange also includes an orientation sensor for measuring orientation, and the method also includes the processor analyzing the orientation to confirm ejection to atmosphere. The injection event may be a needle occlusion, and the method may also include detecting the needle occlusion when the injection backpressure increases while the plunger member movement is substantially zero. The injection event may be a leak from the injection system, and the method may also include detecting the leak from the injection system when the injection backpressure decreases while the plunger member movement is increasing.

[0028] In one or more embodiments, the method also includes the step of the processor instructing an output device to deliver an alarm signal to indicate the injection time when the clock reaches the injection time. The alarm signal may be an audible alarm signal. The alarm signal may be a visual alarm signal.

[0029]

[0029] In one or more embodiments, the method also includes the processor instructing the output device to terminate delivery of the alarm signal in response to the sensor flange being removably coupled to the syringe body. The method may include the processor instructing the output device to terminate delivery of the alarm signal after a first predetermined time and to resume delivery of the alarm signal after a second predetermined time. The method may also include the processor instructing the output device to terminate delivery of the alarm signal and to deliver a message regarding the missed dose after the first predetermined time.

[0030] In one or more embodiments, the method also includes providing power to the wireless communication device and the wireless communication device attempting to establish a connection with the computing device. The method may also include the wireless communication device establishing a connection with the computing device. The method may also include the sensor flange receiving injection configuration data from the computing device via the wireless communication device. The injection configuration data may include data selected from the group consisting of current date and time, first injection date and time, injection frequency, syringe type, viscosity, temperature, warming time, maximum shear force, multiple injection site regimen data, rewards program data, and education / marketing data.

[0031]

[0031] In one or more embodiments, the method also includes storing the measured first and second characteristics in a memory module. The method can include the wireless communication device establishing a connection with the computing device and the sensor flange transmitting the measured characteristics to the computing device using the wireless communication device. The method can also include storing post-injection data in the memory module. The post-injection data includes data selected from the group consisting of injection date and time, injection frequency, plunger force, injection elapsed time, injection error related data, viscosity, temperature, warming time, shear force, drug remaining in the syringe, multiple injection site regimen data, rewards program data, and education / marketing data. The injection error can be selected from the group consisting of drug identification error, injection timing error, dosage error, shear force error, degassing error, residual drug remaining in the syringe, and multiple site injection error.

[0032]

[0032] In one or more embodiments, the method also includes the wireless communication device establishing a connection with the computing device and the sensor flange transmitting post-injection data to the computing device using the wireless communication device. The sensor flange may also include an attachment sensor, and the method may include the attachment sensor detecting a coupling status of the sensor flange to the syringe body. The method also includes the sensor flange detecting the injection, the clock measuring a predetermined time after the detected injection, and the processor directing the output device to output an alarm signal when the coupling status indicates that the sensor flange is coupled to the syringe body at the predetermined time.

[0033] In one or more embodiments, the method also includes placing the sensor flange in a low power mode when the coupling status indicates that the sensor flange is not coupled to the syringe body. Placing the sensor flange in the low power mode includes deactivating the output device and the wireless communication device and intermittently measuring the characteristic to determine the coupling status of the sensor flange and the syringe body.

[0034] In one or more embodiments, the method also includes the step of a processor calculating a shear force on the injectable material within the syringe based at least in part on the movement of the plunger member and the injection backpressure, and may include the step of the processor instructing an output device to output an alarm signal when the calculated shear force exceeds a predetermined maximum shear force.

[0035] In one or more embodiments, the first sensor is a motion sensor and the first injection characteristic is a velocity of the plunger member. The method may also include the step of the processor instructing an output device to issue a velocity alert when the velocity of the plunger member is outside of a predetermined range. The velocity alert may be indicative of the velocity of the plunger member being below or above the predetermined range.

[0036] In one or more embodiments, the injection event is a completion of the injection, and the method also includes the step of the processor instructing the output device to deliver a multiple site administration message. The first injection characteristic can include a sound indicating the completion of the injection.

[0037]

[0037] In one or more embodiments, the first and second sensors are selected from the group consisting of an acoustic sensor, a motion sensor, a proximity sensor, a temperature sensor, a force sensor, an accelerometer sensor, an orientation sensor, and an optical sensor. The method may also include the processor generating a force profile. The method may also include the processor determining that the injection is complete if the force profile includes a sudden increase in force. The method may also include the processor determining that the injection is successful when the measured distance traveled by the plunger rod is equal to a predetermined value.

[0038] In one or more embodiments, the method also includes the processor calculating an approximate time for the injectable substance to reach an injection temperature based at least in part on the measured temperature. The method may also include the processor directing an output device to output an alarm signal when the measured temperature reaches the injection temperature. The method may also include the processor determining that the injection is successful when the measured acceleration of the plunger member drops to substantially zero.

[0039] In one or more embodiments, the method also includes the processor instructing the output device to deliver an alarm signal when the sensor flange detects an injection error, which may be selected from the group consisting of a drug identification error, an injection timing error, a dosage error, a shear force error, a degassing error, residual drug remaining in the syringe, and a multiple site injection error.

[0040] In one or more embodiments, the method also includes removing the sensor flange from the syringe after the injection is completed. If the sensor flange is removably coupled to the syringe body, the method may also include sliding the sensor flange along a longitudinal axis of the syringe body until the sensor flange contacts a syringe flange of the syringe body.

[0041] In yet another embodiment, a system for injection includes a syringe body having a proximal end and a distal end and a syringe interior. The system also includes a stopper member disposed within the syringe interior. The system further includes a smart plunger member coupled to the stopper member and configured to be manipulated to distally insert the stopper member into the syringe interior relative to the syringe body. Additionally, the system includes a needle coupled to the distal end of the syringe body. Additionally, the system includes an RFID tag configured to be activated upon injection.

[0042]

[0042] A preferred embodiment of the smart plunger member is one that is utilized with a syringe that is pre-filled with medication by the manufacturer. Alternatively, the smart plunger member may be used with a syringe that is filled by the administering user prior to administering the injection. In either case, the smart plunger member is either pre-attached to the syringe or attached to the syringe at the time of injection.

[0043] In one or more embodiments, the RFID tag includes an RFID processor and a shunt that shunts power from the RFID processor to reversibly deactivate the RFID tag. The smart plunger member can include a moveable proximal end pad having a cutting member configured to cut the shunt when pressure is applied to the plunger proximal end pad, thereby activating the RFID tag.

[0044] In one or more embodiments, the RFID tag includes an RFID processor and an open circuit that reversibly deactivates the RFID tag. The smart plunger member can include a moveable proximal end pad having a conductive member configured to close the open circuit when pressure is applied to the plunger proximal end pad, thereby activating the RFID tag.

[0045] In one or more embodiments, the smart plunger member includes a proximal end pad and the RFID tag includes a helical antenna disposed within the proximal end pad. The RFID tag may include an elongated antenna disposed within the plunger member. The RFID tag may include a pair of elongated antennas disposed within the plunger member.

[0046] In one or more embodiments, the RFID tag is selected from the group consisting of low frequency, high frequency, and very high frequency. The RFID tag may include a battery.

[0047] In yet another embodiment, a method of collecting information regarding an injection includes providing an injection system. The system includes a syringe body having a proximal end and a distal end and a syringe interior. The system also includes a stopper member disposed within the syringe interior. The system further includes a smart plunger member coupled to the stopper member and having a moveable proximal end pad. Additionally, the system includes a needle coupled at its distal end to the syringe body. Additionally, the system includes an RFID tag. The method also includes manipulating the proximal end pad of the plunger member to insert the stopper member distally into the syringe interior relative to the syringe body to perform the injection. Manipulating the proximal end pad of the smart plunger member to insert the stopper member moves the proximal end pad distally relative to the plunger member, thereby activating the RFID tag.

[0048] In one or more embodiments, the RFID tag includes an RFID processor and a shunt that shunts power from the RFID processor to reversibly deactivate the RFID tag. The moveable proximal end pad may include a cutting member configured such that distal movement of the proximal end pad causes the cutting member to sever the shunt, thereby activating the RFID tag.

[0049] In one or more embodiments, the RFID tag includes an RFID processor and an open circuit that reversibly deactivates the RFID tag. The movable proximal end pad may include a conductive member. Distal movement of the proximal end pad closes the open circuit, thereby activating the RFID tag.

[0050] In one or more embodiments, the RFID tag includes a helical antenna disposed on the proximal end pad. The RFID tag can include an elongated antenna disposed within the plunger member. The RFID tag can include a pair of elongated antennas disposed within the plunger member.

[0051] In one or more embodiments, the RFID tag is selected from the group consisting of low frequency, high frequency, and very high frequency. The RFID tag may include a battery.

[0052]

[0052] In one or more embodiments, the method also includes the RFID tag establishing a connection with the RFID reader. The method may also include the RFID tag transmitting injection data to the RFID reader. The injection data may include data selected from the group consisting of drug name, drug dosage, serial number, and expiration date. The method may also include the RFID tag receiving the data from the RFID reader. The method may also include the RFID tag deactivating itself in response to receiving the data from the RFID reader.

[0053]

[0053] In one or more embodiments, the sensor is a mechanical sensor and the injection characteristic is a position, velocity, or acceleration of the plunger member. The mechanical sensor may include a roller in contact with an outer surface of the plunger member and a reader. The method may also include the reader measuring rotation of the roller. The reader may be an optical or mechanical sensor. The mechanical sensor may include a contact switch. The plunger member may include a feature. The injection characteristic may be a position of the plunger member. The method may further include the feature activating the contact switch.

[0054]

[0054] In one or more embodiments, the sensor can be an optical sensor. The injection system can include a light source and a light directing optical element. The injection characteristic can be a position of the stopper member. The method can also include a light directing optical element directing light from the light source and the reflected light to the optical sensor. A sensor flange can be removably coupled to the syringe body at a location at least partially distal to the syringe flange.

[0055] In one or more embodiments, the sensor is a first sensor and the injection characteristic is a first injection characteristic. The sensor flange may also include a second sensor. The method may also include the step of the second sensor measuring a second injection characteristic.

[0056] In one or more embodiments, the method also includes manipulating the sensor flange to distally insert the stopper member into the syringe relative to the syringe body. The plunger member may include a proximal end pad. The method may also include manipulating the proximal end pad simultaneously with the sensor flange to distally insert the stopper member into the syringe relative to the syringe body.

[0057]

[0057] In one or more embodiments, the sensor flange also includes an attachment sensor. The method may also include the step of the attachment sensor detecting whether the sensor flange is removably coupled to the syringe body. The method may further include the step of the sensor flange sending an alarm when injection of the dose of the medical fluid is completed to prevent the sensor flange from being prematurely discarded. Additionally, the method may include the step of the sensor flange silencing the alarm when the attachment sensor indicates that the finger flange has been removed from the syringe body. The attachment sensor may include a mechanical switch. The sensor flange may also include one or more of a battery, a speaker, an indicator light, a clock, a calendar, a non-volatile computer memory, a tactile feedback device, and a display device.

[0058] In one or more embodiments, the method also includes the sensor flange comparing the measured force-time product to a reference force-time product to determine the occurrence of an injection event. The method may also include the sensor flange recording a time and date of the occurrence of the injection event. The reference force-time product may be predetermined based on the viscosity of the medical fluid to be injected and the size of the needle.

[0059]

[0059] In one or more embodiments, the sensor flange also includes a display, and the method further includes the display communicating information to a user administering the injection. The method may also include the display alerting the user if the injection may be too fast or too slow. The sensor flange may include a speaker, and the method further includes the speaker generating an audible sound to communicate with the user administering the injection. The method may also include the speaker alerting the user if the injection may be too fast or too slow. The sensor flange may include a calendar, a clock, and one or more output devices to deliver an audible, visual, and / or tactile alarm. The method may also include the sensor flange indicating that it is time for an injection.

[0060] In one or more embodiments, the method also includes the sensor flange communicating with a computer network communication protocol that an injection event has occurred. The method may also include the sensor flange communicating intermittently / asynchronously or constantly.

[0061]

[0061] In one or more embodiments, the sensor flange also includes a calendar and a clock, where the sensor flange stores a date and time of the occurrence of the injection event in the non-volatile memory as injection event data. The injection event data may include an F×t product, an injection execution indicator, a temperature, a speed, a pressure, and an indicator of a squirt into air / injection into the patient. The method may also include transmitting the stored injection event data when network communication is established between the sensor flange and a computer network. The method may include the sensor flange transmitting the injection event data to one or more of a smartphone, a computer, a database, a cloud computing network, a medical professional, a patient injecting at home, an electronic medical record, a smartphone app, a doctor, a nurse, a caregiver, a health insurance company, a clinical trial site, a clinical trial administrator, a pharmaceutical distribution company, and a pharmaceutical manufacturer. The sensor flange may also include an output device. The method may also include the output device generating an alarm if turbulence is detected in the injection system.

[0062]

[0062] The above and other embodiments are described in the following detailed description. [Brief description of the drawings]

[0063]

[0063] The foregoing and other features of the embodiments will be described in further detail with reference to the accompanying drawings, in which like elements in different figures are referred to by common reference numerals. [Figure 1] 1A-1B show various features of a conventional syringe configuration. [Diagram 2] 2A-2B show various features of a conventional syringe configuration. [Diagram 3] FIG. 3 illustrates various features of a conventional syringe design. [Figure 4] 4A-4B show various features of a conventional syringe configuration. [Diagram 5] 5A-5C show various features of a conventional syringe configuration. [Figure 6] FIG. 6 illustrates a sensor flange removably coupled to an injection system according to one embodiment. [Figure 7] FIG. 7 illustrates a sensor flange removably coupled to an injection system according to one embodiment. [Figure 8] FIG. 8 illustrates an optical motion sensor for use with a sensor flange according to one embodiment. [Figure 9] FIG. 9 illustrates an acoustic distance meter for use with a sensor flange according to one embodiment. [Figure 10] Figure 10A shows an injection system to which the sensor flange can be removably coupled according to one embodiment, Figures 10B-10E show a sensor flange removably coupled to an injection system according to one embodiment, and Figure 10F shows a sensor flange according to one embodiment. [Figure 11] 11A-11B illustrate methods of collecting injection information according to various embodiments. [Figure 12] FIG. 12 illustrates a method for collecting injection information according to various embodiments. [Figure 13] FIG. 13 illustrates a method for collecting injection information according to various embodiments. [Figure 14] 14A-14B illustrate a method for collecting injection information according to various embodiments. [Figure 15] FIG. 15 illustrates a method for collecting injection information according to various embodiments. [Figure 16] FIG. 16 illustrates a method for collecting injection information according to various embodiments. [Figure 17] FIG. 17 illustrates a method for collecting injection information according to various embodiments. [Figure 18] 18A and 18B show an injection system with an RFID tag according to one embodiment. [Figure 19] FIG. 19 illustrates a plunger rod for an injection system having an RFID tag according to one embodiment. [Figure 20]FIG. 20 illustrates a plunger rod for an injection system having an RFID tag according to one embodiment. [Figure 21] FIG. 21 shows an RFID tag and two antennas for use with an injection system according to one embodiment in a deactivated and activated state. [Figure 22] FIG. 22 illustrates a proximal end cap of a plunger rod for an injection system having an RFID tag according to one embodiment. [Diagram 23] 23A and 23B show a plunger rod for an injection system having an RFID tag according to one embodiment in a deactivated and activated state, respectively. [Figure 24] FIG. 24 shows an RFID tag and two antennas for use with an injection system according to one embodiment in a deactivated and activated state. [Diagram 25] FIG. 25 shows an RFID tag and helical antenna for use with an injection system according to one embodiment. [Figure 26] FIG. 26 illustrates a proximal end cap of a plunger rod for an injection system having an RFID tag according to one embodiment. [Figure 27] FIG. 27 illustrates a smartphone with an RFID receiver according to one embodiment. [Figure 28] 28A and 28B show a phone case with an RFID receiver according to one embodiment. [Figure 29] FIG. 29 illustrates a method of transmitting injection information using an RFID chip, according to one embodiment. [Diagram 30] FIG. 30 shows a sensor flange according to another embodiment. [Diagram 31] FIG. 31 is a graph showing injection force versus time, according to one embodiment. [Diagram 32] FIG. 32 illustrates a method of determining completion of injection of a given dose using an injection system, according to one embodiment. [Diagram 33] FIG. 33 is a graph showing injection force x t versus thumb force according to various embodiments. [Diagram 34] FIG. 34 shows a sensor flange according to yet another embodiment. [Diagram 35] FIG. 35 shows a sensor flange (FIG. 35) removably coupled to an injection system (FIG. 36) according to yet another embodiment. [Diagram 36] FIG. 36 shows a sensor flange (FIG. 35) removably coupled to an injection system (FIG. 36) according to yet another embodiment. [Figure 37] FIG. 37 shows a sensor flange (FIGS. 37 and 38) removably coupled to an injection system (FIGS. 39 and 40) according to another embodiment. [Figure 38] FIG. 38 shows a sensor flange (FIGS. 37 and 38) removably coupled to an injection system (FIGS. 39 and 40) according to another embodiment. [Figure 39] FIG. 39 shows a sensor flange (FIGS. 37 and 38) removably coupled to an injection system (FIGS. 39 and 40) according to another embodiment. [Diagram 40] FIG. 40 shows a sensor flange (FIGS. 37 and 38) removably coupled to an injection system (FIGS. 39 and 40) according to another embodiment. [Diagram 41] FIG. 41 shows a sensor flange (FIG. 41) removably coupled to an injection system (FIGS. 42 and 43) according to yet another embodiment. [Diagram 42] FIG. 42 shows a sensor flange (FIG. 41) removably coupled to an injection system (FIGS. 42 and 43) according to yet another embodiment. [Diagram 43] FIG. 43 shows a sensor flange (FIG. 41) removably coupled to an injection system (FIGS. 42 and 43) according to yet another embodiment. [Diagram 44] FIG. 44 illustrates a method for collecting injection information according to various embodiments. [Diagram 45] FIG. 45 illustrates a sensor proximal end pad removably coupled to an injection system, according to one embodiment.

[0064]

[0091] In order to better understand how the above and other advantages and objects of the various embodiments are achieved, a more detailed description of the embodiments is provided with reference to the accompanying drawings. It should be noted that the drawings are not drawn to scale, and elements of similar structure or function are represented by similar reference numerals throughout. It will be understood that these drawings depict only certain exemplary embodiments, and therefore should not be considered as limiting the scope of the embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0065]

[0092] Smart Sensor Flange 6 and 7, the injection system (110) includes a syringe body (112), a stopper member (114), a plunger member (116), a needle assembly (118), and a sensor flange (150) removably attached to the syringe body (112). The syringe body (112) includes an open proximal end (120) and an open distal end (122). The syringe body (112) also includes a syringe interior (124), a syringe flange (126) at its proximal end (120), and a syringe coupling member (128) at its distal end (122). In the embodiment shown in FIGS. 6 and 7, the syringe coupling member (128) is a female Luer connector. The stopper member (114) is disposed within the syringe interior (124) and coupled to a plunger member (116) that can be manipulated to distally insert the stopper member (114) to expel an injectable substance (e.g., a fluid) from the syringe interior (124) through a needle assembly (118). The needle assembly (118) includes a needle coupling member (128) at its proximal end and a needle (130) at its distal end. In the embodiment shown in Figures 6 and 7, the coupling member (128) is a female luer connector configured to form a fluid-tight connection / seal with a male luer connector (127) at the distal end (122) of the syringe body (112). The plunger member (116) includes a proximal end pad (132) for enabling manual manipulation of the plunger member (116) using one finger of the user's hand (e.g., the thumb) while providing a counterforce with one or more other fingers of the user's hand (e.g., against a body disposed distal to or on the syringe flange (126)).

[0066]

[0093] The sensor flange (150) is shown in FIGS. 6 and 7 as being removably coupled to the syringe body (112). The sensor flange (150) shown in FIGS. 6 and 7 is designed to clip onto the syringe body (112) while being free to slide along the longitudinal axis of the syringe body (112) until the syringe flange (126) contacts the flange force sensor (152) of the sensor flange (150). This mounting / force sensor design has two advantages. The force measurement by the force sensor (152) is approximately the same as the force applied by the user's thumb. Also, since the target (i.e., the syringe body (112)) is relatively large, it is easy to clip onto the sensor flange (150) and activate the mounting sensor (158, described below). The user can snap the large opening / notch (162) of the sensor flange (150) anywhere along the length of the syringe body (112).

[0067]

[0094] As shown in FIG. 6, the sensor flange (150) includes a flange force sensor (152) for detecting a force applied to the sensor flange (150) in a proximal direction. In one embodiment, the flange force sensor (152) may be a partially mechanical device that measures the force applied to compress the sensor flange (150) against the syringe flange (126). In some embodiments, the force measured by the flange force sensor (152) is equal to the force applied distally to the plunger member (116) to move the stopper member (114) distally inwardly within the syringe interior (124). In some embodiments, the force measured by the force flange sensor (152) may be recorded to generate a force profile that may be analyzed to determine the occurrence and timing of a particular injection event. For example, if the force measured in the force profile suddenly increases, a processor (not shown) in the sensor flange (150) may determine that the stopper member (114) has reached the distal end (122) of the syringe body (112) and the injection is complete. Although the flange force sensor (152) is described as a partially mechanical device, a variety of other sensors (e.g., resistance-based, etc.) can function as the flange force sensor, and the time from the start of sustained depression to the end of the injection (e.g., as measured by a clock) can be combined with the applied force information to determine the dose delivered, the backpressure exerted by the patient's tissue, the viscosity of the medication, and other key injection parameters.

[0068]

[0095] The sensor flange (150) also includes a pair of output devices for communicating with the user (e.g., delivering various messages, signals, and / or alarms). The sensor flange (150) includes a display (154) for visually communicating with the user. The display (154) can communicate with binary (i.e., on / off) signals, color signals, text signals / messages, icons, etc. In one embodiment, the display function is performed by an array of small lights. For example, the time until the next injection is represented by the number of lights in the array that are illuminated. Similarly, the compliance score can be represented by the number of lights in the array. The sensor flange (150) includes a speaker (156) for audibly communicating with the user. The speaker (156) can communicate with binary (i.e., beep) sounds, tones, spoken text signals / messages (e.g., using pre-recorded and / or computer-generated voices), etc. Although these output devices (154, 156) are described as displays and / or speakers, various other output devices (eg, haptics, etc.) can be used with the sensor flange according to other embodiments.

[0069]

[0096] The various features of the sensor flange (150) can increase user compliance through various motivational mechanisms. For example, the syringe flange (126) is typically very small and difficult to grasp and manipulate. The much larger sensor flange (150) provides a much more comfortable manipulation surface (e.g., providing a counterforce to thumb forces). The output devices (154, 156) of the sensor flange (150) can provide the user with useful reminders to inject. The sensor flange (150) may store and display compliance data that can earn the user rewards in a compliance program. The sensor flange (150) may generate a compliance score, which can motivate the user to achieve a high compliance score for more "bragging rights" to family, friends, and caregivers.

[0070]

[0097] As shown in FIG. 7, the sensor flange (150) includes an attachment sensor (158) that detects when the sensor flange (150) is removably coupled to the syringe body (112). In one embodiment, the attachment sensor (158) can be a submechanical device (e.g., a switch) that has two states. The attachment sensor (158) has an "unbound" state in which the attachment sensor (158) is not depressed and protrudes from the face of the sensor flange (150) due to a biasing force (e.g., spring actuated). The attachment sensor (158) also has a "bound" state in which the attachment sensor (158) is depressed due to interaction with the exterior surface of the syringe body (112). When the attachment sensor (158) is depressed, a message is sent to a processor (not shown) within the sensor flange (150) to communicate that the sensor flange (150) is removably coupled to the syringe body (112). Although the attached sensor (158) is described as a partially mechanical device, a variety of other sensors (optical, magnetic, electrical, etc.) can also function as the attached sensor.

[0071]

[0098] The sensor flange (150) also includes a motion sensor (160) for measuring motion associated with an injection using the injection system (110). In one embodiment, the motion measured is the motion of the plunger member (116) relative to the syringe body (112). For example, the motion sensor (160) may be an optical sensor configured to trigger when a predetermined optical marker (not shown) on the plunger member (116) passes (i.e., is read) through the optical motion sensor. Such an optical motion sensor (160) may use a computer vision system, such as a barcode reader, to read the predetermined optical marker. Using such a motion sensor (160) and providing the plunger member (116) with a predetermined optical marker such that the predetermined optical marker passes through the motion sensor (160) at the end of the injection, the motion sensor (160) may be used to detect the end of the injection. A similar configuration may be used with the magnetic motion sensor (160) and a magnetic marker (not shown) on the plunger member (116). The sensor flange (150) may also include a clock that allows for measurement of the change in position over time (velocity) and / or the change in velocity over time (acceleration) of the plunger member (116) relative to the sensor flange (150).

[0072]

[0099] In other embodiments, the motion sensor (160) may continuously measure the motion of the plunger member (116), such as along the longitudinal axis of the injection system (110). The motion sensor (160) may be an optical sensor that takes a series of still pictures / images of the plunger member (116) as it moves. The series of still images is sent to an image processor (not shown) in the sensor flange (150). The image processor analyzes the series of still images to detect patterns therein and calculates a pixel shift from one image to the next. In particular, pixels may be identified at edges or other points of interest in the images. This pixel shift may be used to calculate the distance that pixel (and therefore the plunger member (116)) has traveled from one image to the next. This pixel shift and a predetermined time between image frames may be used to calculate the velocity of the plunger member (116) relative to the sensor flange (150). The optical motion sensor (160) may include optics configured to detect small visual features of the plunger member (116), such as scratches, imperfections, textures, etc. In some embodiments, the distances traveled by the plunger members (116) are summed, and the sensor flange (150) determines that the full dose has been delivered when the summed distance reaches approximately the target distance (i.e., a distance sufficient for the stopper member (114) to reach the distal end (122) of the syringe body (112).

[0073]

[0100] Such an optical motion sensor (160) is shown in Figure 8. The optical motion sensor (160) includes an LED light source (164) that directs light onto a measurement surface (166), a number of lenses (168) that focus reflected light from the measurement surface (166), a two-dimensional camera (170), and an image processor (172). The sensor flange (150) may also include a clock that allows for measurement of the change in position over time (velocity) and / or the change in velocity over time (acceleration) of the plunger member (116) relative to the sensor flange (150).

[0074]

[0101] In other embodiments, the motion sensor (160) may be a range finder (e.g., acoustic, infrared, laser, etc.) that measures the distance between the sensor flange (150) and the user's thumb. One advantage of using the range finder motion sensor (160) over other optical motion sensors is that it eliminates the need to visually distinguish multiple portions of the surface of the syringe body (112). Furthermore, writing or other user-generated markings on the syringe body (112) do not interfere with the range finder motion sensor (160). FIG. 9 illustrates an exemplary acoustic range finder that includes a narrowband ultrasonic transducer. The range finder motion sensor (160) illustrated in FIG. 9 includes a narrowband ultrasonic transducer, a transmitter, an amplifier, and a decision circuit. In some embodiments, the acoustic range finder may also emit a sound that can be detected by an acoustic sensor (described below). Since the acoustic range finder can generate an audible output, a speaker is not required. The sensor flange (150) may include a clock that allows for measurement of the change in position over time (velocity) and / or the change in velocity over time (acceleration) of the plunger member (116) relative to the sensor flange (150).

[0075]

[0102] In other embodiments, the motion sensor (160) may be an acoustic sensor that measures sounds associated with the movement of the plunger member (116). In one embodiment, completion of an injection (i.e., movement of the plunger member (116) toward the distal end (122) of the syringe body (112) generates a distinct sound. For example, in a safety needle, completion of an injection causes the needle (130) to be at least partially retracted into the plunger member (116). This needle retraction is accompanied by the release of a spring-loaded latch (not shown) and is accompanied by a distinct sound. The acoustic motion sensor (160) is triggered by this distinct sound (e.g., one or more particular frequencies and amplitudes) that indicates that the injection is complete. In other embodiments, the plunger member (116) or other components of the injection system (110) (e.g., its acoustic distance meter) can be configured to emit a variety of sounds (e.g., particular frequencies, tripping sounds, clicking sounds, "dog whistles," etc.) that can be detected by the acoustic motion sensor (160).

[0076]

[0103] 7, the sensor flange (150) includes an opening (162) configured to allow the sensor flange (150) to be snap-fitted onto the proximal end (120) of the syringe body (112) relative to the syringe flange (126). The sensor flange (150) may be retained in the syringe body (112) by an interference fit.

[0077]

[0104] Although not shown in Figures 6 and 7, the sensor flange (150) can include a power source for driving the various sensors (152, 158, 160) and output devices (154, 156). The power source can be a battery or generator operatively coupled to the injection system (110), such as the plunger member (116), that generates power from the relative motion of the various components of the injection system (110). Alternatively, the power source may utilize a photovoltaic solar cell to charge a rechargeable battery or a capacitor to store power used by the sensor flange.

[0078]

[0105] Although not shown in FIGS. 6 and 7, the sensor flange (150) may also include a communication link that allows the sensor flange (150) to exchange data with a computing device. In some embodiments, the computing device may be a user's smartphone hosting an application configured to interface with the sensor flange (150). The communication link may include a Bluetooth link, a WiFi link, a WiFi Direct link, a near field communication link, a cellular network link, and the like. The communication link provides for data exchange including injection setup data and post-injection data. The injection setup data includes, but is not limited to, current date and time, first injection date and time, injection frequency, syringe type, viscosity, temperature, warming time, maximum shear force, multiple injection site regimen data, rewards program data, and education / marketing data. The post-injection data includes, but is not limited to, the injection date and time, the measured injection parameters described above, and injection error related data. The injection errors include, but are not limited to, drug identification errors, injection timing errors, dosage errors, shear force errors, degassing errors, the amount of drug remaining in the syringe after an injection is performed, and multiple site injection errors. The post-injection data can be utilized for tracking patient compliance, facilitating reward programs, informing insurance programs, etc. Sufficient memory can be provided to store days or weeks of post-injection data. Storing the post-injection data in memory ensures that the post-injection data is not lost even if the user uploads it infrequently or not at all to other computing devices. This facilitates reliable maintenance of the post-injection data even under unfavorable (e.g., compliance) circumstances.

[0079]

[0106] Although not shown in FIGS. 6 and 7, the sensor flange (150) may further include a memory module for storing data. The stored data may include, but is not limited to, the injection setup data and post-injection data described above. Storing the injection setup data may allow the sensor flange (150) to be "programmed" (e.g., wirelessly) before an injection is performed using the injection system (100). Storing the post-injection data may allow the sensor flange (150) to download / transmit (e.g., wirelessly) the injection data to a medical practitioner in a batch operation at a convenient time. For example, the post-injection data may be downloaded in batches when the patient picks up the medication at the pharmacy. The post-injection data may be used to monitor patient compliance and improve patient care. The post-injection data may also be used to calculate compliance courses, facilitate compliance reward programs, modify insurance premiums, etc.

[0080]

[0107] Additionally, although not shown in FIGS. 6 and 7, the sensor flange (150) may include a temperature sensor for managing an injection system that is refrigerated if necessary for temperature sensitive injectable substances. Temperature sensors include physical thermocouples, infrared thermometers, and the like. Such temperature sensors may be configured to measure the temperature of the syringe body (112) and thereby determine the temperature of the injectable substance contained therein. An injection system (110) with a temperature sensor may be configured to notify a user (e.g., with an output device) when the temperature of the syringe body (112) and the injectable substance contained therein reaches a suitable range for injection. Such a system may store the measured temperature during injection. Additionally, such a system may use the measured temperature to calculate an approximate time for the syringe body (112) and the injectable substance contained therein to reach a suitable range for injection. Additionally, the temperature measurement of the agent may be used to calculate the viscosity of the agent for use in calculating the injection pressure or flow rate.

[0081]

[0108] Alternatively, the user can be instructed to wait a predetermined period of time after clipping the sensor flange (150) to allow the refrigerated medication to warm up prior to injection. An output device (e.g., speaker (156)) can then indicate when this approximate warm-up time has expired. A temperature sensor is not required for this method of indicating the expiration of the warm-up time. The injection input and injection time can be used to verify the viscosity of the medication and adjust the warm-up time for the next injection.

[0082]

[0109] Although not shown in FIGS. 6 and 7, the sensor flange (150) may further include a processor that performs various calculations and controls various sensor flange components. The processor may include a clock and may be programmed to instruct an output device to deliver an alarm signal to the user when it is time to inject. The output device may be instructed to emit an alarm signal for a predetermined time (e.g., 1 hour), then silence for a predetermined time (e.g., 1 hour), and repeat the silent alarm cycle until the sensor flange (150) is attached to the syringe body (112) for injection. The processor may also be programmed to instruct the output device to provide advice to the patient when an injection error is detected. For example, if a user is late with an injection, the processor may instruct the output device to provide advice to the user regarding the delay in injection based on the identity of the injectable substance received as part of the injection setup data.

[0083]

[0110] Although not shown in Figures 6 and 7, the sensor flange (150) may also include an orientation sensor that detects when the syringe body (112) is in an "upward" position.

[0084]

[0111] 10A-10F show another embodiment of an injection system (110) used to inject an injectable substance and collect injection information. As shown in FIG. 10A, the injection system (110) includes a syringe body (112) having proximal and distal ends (120, 122), a syringe interior (124), a syringe flange (126) at its proximal end (120), and a syringe coupling member (i.e., a luer connector) at its distal end (122). The injection system (110) also includes a stopper member (114) disposed in the syringe interior (124) and coupled to a plunger member (116). A medication may be pre-loaded in the syringe interior (124). The plunger member (116) includes a proximal end pad (132) that facilitates application of a distal force that moves the stopper member (114) distally relative to the syringe body (112). The plunger member (116) also has a marker (136) that is read by the sensor flange (see FIG. 10D). The marker (136) can include information about the injection system (110) including, but not limited to, the type of syringe, the identity of the injectable substance, and characteristics of the injectable substance such as viscosity, clarity, color, injection temperature, friction between the syringe and the stopper member, the tolerable shear force of the drug during injection, and the preferred injection speed. The marker (136) can be a line, bar code, text, 2D bar code, or other pattern that can be read by an electronic device in the sensor flange to record drug information and / or the movement of the plunger member. The marker (136) may also be provided on the syringe body (112), the syringe flange (126), or elsewhere in the injection system such that the sensor flange (150 in FIG. 10B) can read the marker at the time of or after installation. Alternatively, the injection information may be preprogrammed into the sensor flange at the time of manufacture or downloaded to the flange at a later time. The injection system (110) further includes a luer cap (134) that fluidly seals the female luer connector (128) before the needle assembly is removably coupled thereto (see FIG. 10C).

[0085]

[0112] FIG. 10B illustrates the next step in the preparation / injection process, where the sensor flange (150) is removably coupled to the syringe body (112). The sensor flange (150) includes an opening (162) configured to allow the sensor flange (150) to be snapped onto the proximal end (120) of the syringe body (112) relative to the syringe flange (126). Unlike the sensor flange (150) illustrated in FIGS. 6 and 7, which is snapped onto the syringe body (112) such that the proximal face of the sensor flange (150) abuts the distal face of the syringe flange (126), the opening (162) of the sensor flange (150) illustrated in FIG. 10B is configured such that the syringe flange (126) is disposed within the sensor flange (150) when the sensor flange (150) is attached to the syringe body (112). The sensor flange (150) may be retained in the syringe body (112) by an interference fit.

[0086]

[0113] FIG. 10C shows the sensor flange (150) removably coupled to the syringe body (112). In this configuration, the injection system (110) is ready to perform an injection while collecting information related to the injection. FIG. 10C shows a predetermined optical marker (136) on the plunger member (116). The predetermined optical marker (136) is configured to be read by an optical sensor of the sensor flange (150) as the predetermined optical marker (136) passes through the sensor flange (150). The optical sensor may read the predetermined optical marker (136) using a computer vision system such as a barcode reader. The sensor flange (150) can be used to detect the end of an injection by placing the predetermined optical marker (136) on the plunger member (116) such that the predetermined optical marker enters the sensor flange (150) and is read at the end of the injection. Although a single optical marker (136) is shown in FIG. 10C, the sensor flange (150) system may be configured with multiple optical markers to increase the fidelity and resolution of the motion sensor.

[0087]

[0114] 10D illustrates the injection system (110) after a distal force has been applied to the proximal end pad (132) of the plunger member (116). In one embodiment, a distal force can be applied to the proximal end pad (132) with the thumb of the user's hand while one or more other fingers of the user's hand are held against the distal surface of the sensor flange (150). The other fingers of the user's hand also apply a proximal force to the distal surface of the sensor flange (150) to move the plunger member (116) and its attached stopper member (114) distally within the syringe interior (124). Distal movement of the stopper member (114) within the syringe interior (124) increases pressure within the syringe interior (124), forcing the injectable substance within the syringe interior (124) out of the needle (130) and injecting the injectable substance into the tissue penetrated by the needle. In FIG. 10D, a predetermined optical marker (136) on the plunger member (116) is in a position before entering the sensor flange (150) and before reading, which corresponds to a position of the stopper member (114) near (but not yet at) the end of the injection.

[0088]

[0115] FIG. 10E illustrates the injection system (110) after the predetermined optical marker (136) has entered the sensor flange (150) and been read. The predetermined optical marker (136) may encode injection setup information that is read by an optical sensor in the sensor flange (150). The injection setup data may include, but is not limited to, first injection date and time, injection frequency, syringe type, temperature, viscosity, warming time, maximum shear force, multiple injection site regimen data, rewards program data, and education / marketing data. FIG. 10E also illustrates that the stopper member (114) is at the distal end (122) of the syringe body (112) upon completion of an injection. The predetermined optical marker (136) is provided on the plunger member (116) such that when the stopper member (114) is at the distal end (122) of the syringe body (112), the predetermined optical marker (136) is positioned within the sensor flange (150) for reading by the optical sensor. Thus, the reading of the predetermined optical marker (136) by the sensor flange (150) corresponds to an injection event of complete injection.

[0089]

[0116] After an injection is completed, the needle (130) may or may not be retracted into the syringe interior (124) and / or plunger member (116). Additionally, after an injection is completed, the sensor flange (150) may be detached from the syringe body (112) and reused in another syringe body (112) for another injection. The used syringe body (112), stopper member (114), plunger member (116), and needle assembly (118) may be safely discarded after removing the sensor flange (150). The reusability of the sensor flange (150) may reduce medical costs by reusing a relatively expensive portion of the injection system (110) (e.g., compared to the syringe body (112)).

[0090]

[0117] FIG. 10F illustrates a sensor flange (150) for use with the injection system (110) illustrated in FIGS. 10A-10E. The sensor flange (150) includes a pair of output devices (154, 156), an opening (162), and an optical sensor (160) disposed adjacent the opening (162). The output devices (154, 156) communicate with the user (e.g., deliver various messages, signals, and / or alarms to the user). The sensor flange (150) includes a display (154) for visually communicating with the user. The display (154) can communicate with binary (i.e., on / off) signals, color signals, icons, descriptive text signals / messages, and the like. In one embodiment, the display function is performed by an array of small lights. For example, the time until the next injection is represented by the number of lights that are illuminated in the array. Similarly, a compliance score can be represented by the number of lights illuminated in the array. The sensor flange (150) also includes a speaker (156) for audibly communicating with a user. The speaker (156) can communicate binary (i.e., beeps), tones, and spoken text signals / messages (e.g., using pre-recorded and / or computer-generated voices). Although the output devices (154, 156) are described as displays and / or speakers, in other embodiments, a variety of other output devices (e.g., haptics, etc.) can be used with the sensor flange.

[0091]

[0118] Having described an exemplary sensor flange, a method for gathering injection information using the sensor flange according to various embodiments will now be described.

[0092]

[0119] 11A illustrates a method (200) for collecting injection information according to one embodiment. At step (212), a sensor flange, such as the sensor flange (150) described above, is removably coupled to a syringe body of an injection system. The injection system may be similar or identical to injection system (110) described above. The sensor flange may be secured to the syringe body using an interference fit.

[0093]

[0120] At step (214), an injection is performed by manipulating a plunger member of the injection system, for example using a finger of the user's hand (e.g., thumb) to apply a force against a proximal end pad of the plunger member while one or more other fingers of the user's hand provide a counter force (e.g., against the distal side of a syringe flange or a sensor flange disposed thereon).

[0094]

[0121] In step (216), the sensor flange measures a first injection characteristic using a first sensor. Similarly, in step (218), the sensor flange measures a second injection characteristic using a second sensor. The first and second sensors may be any known type of sensor, including but not limited to acoustic sensors, motion sensors, proximity sensors, temperature sensors, force sensors, accelerometer sensors, orientation sensors, and optical sensors. The first and second sensors may be the same type of sensor or different types of sensors. The type of sensor may be selected to measure the type of injection characteristic required for method (200).

[0095]

[0122] At step (220), the sensor flange (i.e., the processor therein) analyzes the first and second injection characteristics to monitor an injection event (e.g., injection completion, plunger force, shear force, ejection error, etc.). The type of injection event monitored by method (200) determines the type of injection characteristic measured by the type of sensor in the sensor flange.

[0096]

[0123] FIG 11B illustrates a method (200') for collecting injection information according to another embodiment. The method (200') illustrated in FIG 11B is similar to the method illustrated in FIG 11A. However, rather than measuring only first and second injection characteristics (as in the method (200) illustrated in FIG 11A), the method (200') illustrated in FIG 11B measures and analyzes more than two injection characteristics.

[0097]

[0124] At step 212, a sensor flange, such as sensor flange 150 described above, is removably coupled to a syringe body of an injection system, which may be similar or identical to injection system 110 described above. The sensor flange may be secured to the syringe body using an interference fit.

[0098]

[0125] At step (214), an injection is performed by manipulating a plunger member of the injection system, for example using a finger of the user's hand (e.g., thumb) to apply a force against a proximal end pad of the plunger member while one or more other fingers of the user's hand provide a counter force (e.g., against the distal side of a syringe flange or a sensor flange disposed thereon).

[0099]

[0126] At step (216), the sensor flange measures a first injection characteristic using a first sensor.

[0100]

[0127] In step (222), the sensor flange measures the second, third, fourth, etc. injection characteristic using the second, third, fourth, etc. sensors. The first, second, third, fourth, etc. sensors may be any known type of sensor, including but not limited to acoustic sensors, motion sensors, proximity sensors, temperature sensors, force sensors, accelerometer sensors, orientation sensors, and optical sensors. The first, second, third, fourth, etc. sensors may be the same type of sensor or may be different types of sensors. The type of sensor may be selected to measure the type of injection characteristic required for the method (200').

[0101]

[0128] In step (224), the sensor flange (i.e., the processor therein) analyzes the first, second, third, fourth, etc. injection characteristics to monitor (e.g., detect, measure, determine, etc.) an injection event (e.g., injection completion, plunger force, shear force, injection error, etc.). The type of injection event monitored during method (200') determines the type of injection characteristic measured by the type of sensor in the sensor flange.

[0102]

[0129] 12 illustrates a method (300) for collecting injection information according to another embodiment. At step (312), a sensor flange, such as the sensor flange (150) described above, is removably coupled to a syringe body of an injection system. The injection system may be similar or identical to the injection system (110) described above. The sensor flange may be secured to the syringe body using an interference fit.

[0103]

[0130] At step (314), an injection is performed by manipulating a plunger member of the injection system, for example using a finger of the user's hand (e.g., thumb) to apply a force against a proximal end pad of the plunger member while one or more other fingers of the user's hand provide a counter force (e.g., against the distal side of a syringe flange or a sensor flange disposed thereon).

[0104]

[0131] In step (316), as described above, the sensor flange measures the injection backpressure using a force sensor. For example, as the plunger member moves into the syringe to perform an injection, the force sensor in the sensor flange measures the proximal force on a surface of the sensor flange (distal, proximal, interior, etc.). The force on the sensor flange is approximately equal to the force applied to the plunger member at a stopper member attached to the plunger member to perform an injection. In some embodiments, the force on the sensor flange is continuously measured and a force profile is generated and stored in the memory of the sensor flange.

[0105]

[0132] In step (318), the sensor flange measures the movement of the plunger using a motion sensor, as described above. For example, the motion sensor may be an optical sensor, an IR sensor, an acoustic sensor, an ultrasonic distance finder, etc. The amount of movement (distance traveled) detected by the motion sensor can be combined with elapsed time from a clock on the sensor flange to derive the velocity and acceleration of the movement. In some embodiments, the sensor flange continuously measures the distance, velocity, and / or acceleration of the plunger and stores the measured parameters in a memory on the sensor flange.

[0106]

[0133] At step (320), the sensor flange (i.e., the processor therein) analyzes the injection backpressure and the movement of the plunger to monitor (i.e., detect) a blow-to-atmosphere event. For example, the processor in the sensor flange can be programmed to detect a blow-to-atmosphere event if the injection backpressure remains substantially low as the plunger member is moving distally. The sensor flange may use fluid equations (e.g., fluid flow through an orifice, Bernoulli's equation, Hagen-Poiseuille's equation, or other methodology) to calculate the expected hydraulic pressure difference between the injection backpressure in the syringe chamber and the pressure at the tip of the needle. The sensor flange can perform this calculation using specific parameters of the injection system (e.g., needle dimensions, syringe body dimensions, stopper member dimensions, and properties of the injectable substance (e.g., drug)). The parameters of the injection system include, but are not limited to, the inner diameter of the needle, the length of the needle, the shape of the needle tip, the diameter of the syringe body, the force on the sensor flange or the proximal end pad of the plunger member, the speed of the movement of the plunger member, the dynamic and static friction forces between the stopper member and the syringe body, the temperature and / or viscosity of the injectable substance (e.g., drug), the density of the injectable substance (e.g., drug), and / or other metrics to perform the calculation. The injection back pressure can be calculated by measuring the force on the proximal end pad / sensor flange, subtracting the friction force from the stopper member sliding inside the syringe, and dividing the result by the cross-sectional area inside the syringe. If the calculated pressure drop indicates that the pressure at the tip of the needle is about 1 atmosphere, the sensor flange determines a blow-to-air. If the calculated pressure at the tip of the needle is greater than 1 atmosphere, the sensor flange determines an injection into the patient. A blow-to-air event may or may not be an injection error depending on its duration and the orientation of the injection system during the blow-to-air event. For example, air bubbles inside a syringe can be expelled from the needle by orienting the syringe body with the needle pointing generally upwards and briefly jetting it into the atmosphere, which will push the air bubbles out of the needle as they migrate to the distal / top end of the syringe.On the other hand, if the blow-to-air event continues substantially throughout the entire injection (i.e., until the stopper member reaches the distal end inside the syringe), it indicates an error in which the injection occurred before the needle was properly positioned into the target tissue. In either case, the blow-to-air event, its timing, and duration can be stored in the memory of the sensor flange.

[0107]

[0134] In optional step (322), the sensor flange measures the orientation of the syringe flange and therefore the orientation of the syringe body coupled thereto. In optional step (324), the processor and syringe flange analyze the orientation to determine the type of blow-to-air event. If the orientation of the syringe body is generally upward and the duration of the blow-to-air event is relatively short, the processor identifies the blow-to-air event as a debubbling process. If the orientation of the syringe body is not generally upward and the blow-to-air event continues substantially throughout the injection, the processor identifies the blow-to-air event as an error. In either case, the orientation of the syringe body can be stored in a memory of the sensor flange. The sensor flange may transmit an alarm signal (e.g., visual or audible) to alert a user when an injection-to-air error event is detected.

[0108]

[0135] 13 illustrates a method (400) for collecting injection information according to yet another embodiment. At step (412), a sensor flange, such as the sensor flange (150) described above, is removably coupled to a syringe body of an injection system. The injection system may be similar or identical to the injection system (110) described above. The sensor flange may be secured to the syringe body using an interference fit.

[0109]

[0136] At step (414), an injection is performed by manipulating a plunger member of the injection system, for example using a finger of the user's hand (e.g., thumb) to apply a force against a proximal end pad of the plunger member while one or more other fingers of the user's hand provide a counter force (e.g., against the distal side of a syringe flange or a sensor flange disposed thereon).

[0110]

[0137] At step (416), the sensor flange measures the injection backpressure using a force sensor, as described above. For example, as the plunger member moves into the syringe interior to perform an injection, the force sensor in the sensor flange measures the proximal force on a surface of the sensor flange (distal, proximal, interior, etc.). The force on the sensor flange is approximately equal to the force applied to the plunger member at a stopper member attached to the plunger member to perform an injection. In some embodiments, the force on the sensor flange is continuously measured and a force profile is generated and stored in the memory of the sensor flange.

[0111]

[0138] In step (418), the sensor flange measures the movement of the plunger using a motion sensor, as described above. For example, the motion sensor may be an optical sensor, an IR sensor, an acoustic sensor, an ultrasonic distance finder, etc. The amount of movement (distance traveled) detected by the motion sensor can be combined with elapsed time from a clock on the sensor flange to derive the velocity and acceleration of the movement. In some embodiments, the sensor flange continuously measures the distance, velocity, and / or acceleration of the plunger and stores the measured parameters in a memory on the sensor flange.

[0112]

[0139] At step (420), the sensor flange (i.e., the processor therein) analyzes the injection backpressure and the movement of the plunger to monitor (i.e., detect) a needle occlusion event. For example, the processor of the sensor flange can be programmed to detect a needle occlusion event if the injection backpressure increases while the movement of the plunger member is substantially stopped. The needle occlusion event may or may not be an injection error depending on the position of the plunger member during the needle occlusion event. For example, when the plunger member and the stopper member are at the distal end inside the syringe at the end of the injection, the movement of the plunger member is essentially zero, but the force measured by the sensor flange (i.e., the injection backpressure) increases with the force applied by the user. Such a needle occlusion event is a normal part of the end of the injection. On the other hand, if the needle occlusion event occurs before the plunger member reaches the full insertion depth, the needle occlusion event may be an injection error. In that case, the needle occlusion event, its timing, and the position of the plunger member are stored in the memory of the sensor flange. The sensor flange may also transmit an alarm signal (e.g., visual or audible) to alert the user when a needle occlusion error event is detected.

[0113]

[0140] 14A illustrates a method (500) for collecting injection information according to yet another embodiment. At step (512), a sensor flange, such as the sensor flange (150) described above, is removably coupled to a syringe body of an injection system. The injection system may be similar or identical to injection system (110) described above. The sensor flange may be secured to the syringe body using an interference fit.

[0114]

[0141] At step (514), an injection is performed by manipulating a plunger member of the injection system, for example using a finger of the user's hand (e.g., thumb) to apply a force against a proximal end pad of the plunger member while one or more other fingers of the user's hand provide a counter force (e.g., against the distal side of a syringe flange or a sensor flange disposed thereon).

[0115]

[0142] At step (516), the sensor flange measures the injection backpressure using a force sensor, as described above. For example, as the plunger member moves into the syringe to perform an injection, the force sensor in the sensor flange measures the proximal force on a surface of the sensor flange (distal, proximal, interior, etc.). The force on the sensor flange is approximately equal to the force applied to the plunger member at a stopper member attached to the plunger member to perform an injection. In some embodiments, the force on the sensor flange is continuously measured and a force profile is generated and stored in the memory of the sensor flange.

[0116]

[0143] At step (518), the sensor flange measures the movement of the plunger using a motion sensor, as described above. For example, the motion sensor may be an optical sensor, an IR sensor, an acoustic sensor, an ultrasonic distance finder, etc. The amount of movement (distance traveled) detected by the motion sensor can be combined with elapsed time from a clock on the sensor flange to derive the velocity and acceleration of the movement. In some embodiments, the sensor flange continuously measures the distance, velocity, and / or acceleration of the plunger and stores the measured parameters in a memory on the sensor flange.

[0117]

[0144] At step (520), the sensor flange (i.e., the processor therein) analyzes the injection leak pressure and the movement of the plunger to monitor (i.e., detect) a system leak event. For example, the processor of the sensor flange can be programmed to detect a system leak event if the injection backpressure drops from a non-zero value to essentially zero as the plunger member is moving distally. This system leak event, its timing, and duration may be stored in the memory of the sensor flange. The sensor flange may also transmit an alarm signal (e.g., visual or audible) to alert a user upon detecting a system leak event.

[0118]

[0145] 14B illustrates a method (500') for collecting injection information according to another embodiment. At step (512), a sensor flange, such as the sensor flange (150) described above, is removably coupled to a syringe body of an injection system. The injection system may be similar or identical to the injection system (110) described above. The sensor flange may be secured to the syringe body using an interference fit.

[0119]

[0146] At step (514), an injection is performed by manipulating a plunger member of the injection system, for example using a finger of the user's hand (e.g., thumb) to apply a force against a proximal end pad of the plunger member while one or more other fingers of the user's hand provide a counter force (e.g., against the distal side of a syringe flange or a sensor flange disposed thereon).

[0120]

[0147] In step (522), the sensor flange measures the force / injection back pressure using a force sensor as described above. For example, as the plunger member moves into the syringe to perform an injection, the force sensor in the sensor flange measures the proximal force on a surface (distal, proximal, internal, etc.) of the sensor flange. The force on the sensor flange is approximately equal to the force applied to the plunger member at the stopper member attached to the plunger member to perform an injection. The difference in the method (500') shown in FIG. 14B is that the force / injection back pressure is measured over time (e.g., continuously). The difference in the method (500') shown in FIG. 14B is that the force / injection back pressure is measured over time (e.g., continuously).

[0121]

[0148] At step (524), the sensor flange generates a force profile from the measured force / injection backpressure over time.

[0122]

[0149] At step (526), ​​the sensor flange (i.e., the processor therein) analyzes the force profile to monitor (i.e., detect) an injection event. For example, the force profiles of various injection systems have characteristic "signature" shapes that reflect the physics of the injection system. A typical injection event begins with a large force "bump" as the friction of the stopper member is overcome. Then, the force drops to a lower level as the stopper member slides and the injectable substance is forced out of the syringe interior. Finally, another small force "bump" occurs as the stopper member bottoms out of the syringe body. This slide time is a function of the slide force. If the user injects quickly, the slide force will be high and the injection time will be short. These relationships fall within known limits for each combination of injectable substance and injection system. Thus, errors can be detected. For example, a squirt into air has a force profile characteristic that is clearly different from an injection into tissue.

[0123]

[0150] Figure 15 illustrates a method (600) for collecting injection information according to an embodiment similar to that shown in Figure 11A. At step (612), a sensor flange, such as the sensor flange (150) described above, is removably coupled to a syringe body of an injection system. The injection system may be similar or identical to injection system (110) described above. The sensor flange may be secured to the syringe body using an interference fit.

[0124]

[0151] At step (614), an injection is performed by manipulating a plunger member of the injection system, for example, using a finger of the user's hand (e.g., thumb) to apply a force against a proximal end pad of the plunger member while one or more other fingers of the user's hand provide a counter force (e.g., against the distal side of a syringe flange or a sensor flange disposed thereon).

[0125]

[0152] At step (616), the sensor flange measures a first injection characteristic using a first sensor. Similarly, at step (618), the sensor flange measures a second injection characteristic using a second sensor. The first and second sensors may be any known type of sensor, including, but not limited to, acoustic sensors, motion sensors, proximity sensors, temperature sensors, force sensors, acceleration sensors, orientation sensors, sensor flange attachment ("mount") sensors, and optical sensors. The first and second sensors may be the same type of sensor or different types of sensors. The type of sensor may be selected to measure the type of injection characteristic required for the method (600).

[0126]

[0153] At step (620), the sensor flange (i.e., the processor therein) analyzes the first and second injection characteristics to monitor (e.g., detect, measure, determine, etc.) an injection event (e.g., completion of injection, plunger force, shear force, ejection error, etc.). The type of injection event monitored in the method (600) determines the type of injection characteristic measured by the type of sensor in the sensor flange.

[0127]

[0154] In an optional step (622), the sensor flange stores post-injection data in the sensor flange's memory. The post-injection data includes, but is not limited to, the measured first and second injection characteristics, data regarding the monitored injection event, injection date and time, injection frequency, plunger force, injection elapsed time, injection error related data, viscosity, temperature, warming time, shear force, residual drug remaining in the syringe, multiple injection site regimen data, rewards program data, and education / marketing data. Injection errors include, but are not limited to, drug identification errors, injection timing errors, dosage errors, shear force errors, degassing errors, residual drug remaining in the syringe, and multiple site injection errors.

[0128]

[0155] In an optional step (624), the sensor flange transmits the post-injection data to a computing device. The sensor flange can be communicatively connected to the computing device using a variety of wired and / or wireless communication devices. Wireless communication devices include, but are not limited to, Bluetooth, WiFi, WiFi Direct, cellular, and near field communication. After the sensor flange establishes a communication link with the computing device, the sensor flange can download the post-injection data to the computing device. In one embodiment, the sensor flange stores the measured, collected, calculated, and generated post-injection data in a memory and then downloads the post-injection data in batches to a computing device (e.g., a user's smartphone or a pharmacy's computing device).

[0129]

[0156] 16 illustrates a method (700) for collecting injection information according to another embodiment. At step (712), a sensor flange, such as the sensor flange (150) described above, is removably coupled to a syringe body of an injection system. The injection system may be similar or identical to the injection system (110) described above. The sensor flange may be secured to the syringe body using an interference fit.

[0130]

[0157] At step (714), an injection is performed using the injection system. For example, a plunger member of the injection system may be manipulated to perform the injection. For example, a finger (e.g., thumb) of the user's hand may be used to apply a force against a proximal end pad of the plunger member, while one or more other fingers of the user's hand provide a counter force (e.g., against a distal side of a syringe flange or a sensor flange disposed thereon).

[0131]

[0158] At step (716), the sensor flange detects that the sensor flange remains coupled to the syringe body for a predetermined time after the injection is performed. In some embodiments, the predetermined time is 1 minute, 2 minutes, or 3 minutes. The sensor flange can detect that it is coupled to the syringe body using a mount sensor having a mechanical switch that is pressed when the sensor flange is coupled to the syringe body. The syringe body remaining coupled to the sensor flange after the injection is completed indicates a situation where the user has forgotten to remove the sensor flange from the syringe body. This then creates the possibility that the sensor flange may be discarded along with the used syringe body. Unintentional discarding of the syringe flange may result in loss of post-injection data and valuable equipment.

[0132]

[0159] At step (718), the sensor flange transmits an alarm signal in response to detecting the coupling of the sensor flange. The alarm may be an audible and / or visual alarm. In another embodiment, the sensor flange can communicate with a mobile computing device (e.g., a cell phone) to sound an alarm or alert with a message on the computing device. In another embodiment, the sensor flange cooperates with a sharps disposal container that does not open for disposal when the sensor flange is attached to a used syringe body, thereby forcing a user to remove the sensor flange before discarding the used syringe body.

[0133]

[0160] In step 720, the sensor flange terminates delivery of the alarm signal in response to detecting that the sensor flange has been removed from the syringe body. For example, removal of the sensor flange from the syringe body 34 causes a mechanical switch to move to a spring-loaded "out" position, indicating to the sensor flange that it is no longer attached to the syringe body. The alarm signal, its cause, and timing can be stored in a memory in the sensor flange.

[0134]

[0161] 17 illustrates a method (800) for collecting injection information according to yet another embodiment. At step (812), a sensor flange, such as the sensor flange (180) described above, is removably coupled to a syringe body of an injection system. The injection system may be similar or identical to injection system (110) described above. The sensor flange may be secured to the syringe body using an interference fit.

[0135]

[0162] At step (814), the sensor flange measures the temperature of the injectable substance inside the syringe of the injection system. The sensor flange may include a temperature sensor, including but not limited to an infrared thermometer and a thermocouple. This temperature sensor may not directly measure the temperature of the injectable substance, but rather the sensor flange (i.e., the processor therein) may estimate the temperature of the injectable substance from the measured temperature (e.g., external to the syringe body).

[0136]

[0163] In step 816, a processor in the sensor flange calculates the time until the injectable substance reaches a suitable temperature for injection. The processor may calculate the time until injection using the measured or estimated current temperature of the injectable substance, the measured room temperature, and information regarding the suitable temperature for injection.

[0137]

[0164] In step (818), the sensor flange delivers an alarm signal in response to the injectable substance within the syringe reaching a suitable temperature for injection. The alarm signal may be an audible alarm and / or a visual alarm. The sensor flange may use a temperature sensor to detect when the injectable substance has reached a suitable temperature for injection. Alternatively, the sensor flange may transmit the alarm signal after the time to injection calculated in step (816) has elapsed.

[0138]

[0165] In step 820, the sensor flange terminates delivery of the alarm signal in response to detecting that the injection is complete. The sensor flange can detect that the injection is complete using any of the methods described herein.

[0139]

[0166] In some embodiments, the sensor flange may receive injection configuration data from the computing device via a communication connection prior to injection. The communication connection may be wired and / or wireless as described above. The injection configuration data includes, but is not limited to, current date and time, first injection date and time, injection frequency, syringe type, viscosity, temperature, warming time, maximum shear force, multiple injection site regimen data, rewards program data, and education / marketing data. The injection configuration data can be used to prepare the injection system for injection as well as to collect post-injection data.

[0140]

[0167] In some embodiments, the sensor flange has a clock, and the processor in the sensor flange may be programmed to command an output device in the sensor flange to send an alarm signal when the clock reaches a predetermined injection time (which may be received as injection setup data). The alarm signal may be an audible and / or visual alarm. An audible alarm may be a simple repeating sound (such as a beep), a tone that changes pitch, a computer generated voice, a previously recorded voice, etc. A visual alarm may be a light that changes binary (light on / off), color, texture, icon, etc. The processor in the sensor flange may be programmed to terminate delivery of the alarm signal when the sensor flange is coupled to the syringe body. The processor in the syringe flange may also be programmed to terminate delivery of the alarm signal after a predetermined time and resume delivery after another predetermined time. After yet another predetermined time, the processor in the syringe flange may be programmed to deliver a missed dose message.

[0141]

[0168] In some embodiments, the sensor flange may include a power source for powering its various components. The power source may be a battery. In other embodiments, the power source is self-generated using the injection action provided by the user. The processor may be programmed to place the sensor flange in a low power mode after the sensor flange has been unattached for a predetermined period of time. In one embodiment, the low power mode includes removing power to the output device and the wireless communication device, and intermittently powering an attachment sensor to detect whether the sensor flange has been attached to the syringe body.

[0142]

[0169] In some embodiments, the processor of the sensor flange is programmed to calculate the shear force on the injectable substance inside the syringe. For example, the shear force can be calculated from the injection back pressure and the movement of the plunger member. In such embodiments, if the calculated shear force exceeds a maximum shear force (which may be downloaded as injection setup data), the processor of the syringe flange instructs an output device to send an alarm signal (e.g., instruct the user to slow down the speed of the plunger member).

[0143]

[0170] In some embodiments, the processor of the sensor flange is programmed to instruct the output device to output an alarm signal (i.e., speed and warning) if the speed of the plunger member is outside of a predetermined range (which may be downloaded as injection setup data). In such embodiments, the alarm signal may include speed up and slow down messages in response to plunger member speed errors detected by the motion sensor as described above.

[0144]

[0171] In some embodiments, the processor of the sensor flange is programmed to deliver a multiple site administration message when a complete injection is detected as described above, including an instruction to move to the next site and an indication that the multiple site administration regimen is complete, although instructions may also be given for single site administration.

[0145]

[0172] In some embodiments, the sensor flange may be used for multi-drug combinations using a dual chamber mixing and injection system. The sensor flange can be used to monitor the position, velocity, or acceleration of the plunger rod and instruct the user on proper injection technique by sounding an alarm if mixing and / or injection is too fast or too slow.

[0146]

[0173] In some embodiments, the sensor flange includes an acoustic sensor configured to detect a sound associated with the completion of an injection, hi such embodiments, the processor of the sensor flange is programmed to record the completion of an injection when the acoustic sensor detects the sound.

[0147]

[0174] Although the clock on the sensor flange (150) has been described as providing for measurement of the change in position over time (velocity) and / or the change in velocity over time (acceleration) of the plunger rod (116) relative to the sensor flange (150), in other embodiments the clock may also be capable of measuring the change in other injection characteristics over time. For example, the clock may be used to allow measurement / calculation of changes in force / pressure, temperature, etc. over time.

[0148]

[0175] Figure 30 shows a sensor flange (1150) according to another embodiment. The sensor flange (1150) is similar to the sensor flange (150) shown in Figures 6, 7, and 10B-10F. The sensor flange (1150) includes a flange force sensor (1152), a pair of output devices (1155, 1156), an opening (1162), and an attached sensor (1158) disposed adjacent the opening (1162).

[0149]

[0176] The sensor flange (1150) is designed to attach to the syringe body (112, see FIGS. 6-7 and their descriptions) in a manner similar to the sensor flange (150) of FIGS. 6-7. The sensor flange (1150) is designed to clip onto the syringe body (112), but to slide freely along the longitudinal axis of the syringe body (112) until the load point (1180) of the flange force sensor (1152) of the sensor flange (1150) contacts the syringe flange (126, see FIGS. 6-7). When the load point (1180) contacts the syringe flange (126), the force applied to the proximal end pad (132) is transferred to the load point (1180) by the movement of the syringe flange (126) relative to the sensor flange (1150), which is held stationary by the user's finger. Load point 1180 is mechanically coupled to force sensor 1152 by lever 1182, which pivots about pivot point 1184. Load point 1180 is approximately 1 / 3 of the distance between pivot point 1184 and the far end of lever 1182 above force sensor 1152, thereby transmitting force through load point 1180 and lever 1182 to force sensor 1152, thereby reducing the force applied to force sensor 1152 (e.g., by approximately 1 / 3). In this configuration, by attenuating the force transmitted to force sensor 1152, an off-the-shelf force sensor 1152 that does not have a sensitivity suitable for this sensor flange 1150 can be utilized. The sensor flange (1150) shown in FIG. 30 includes a lever (1182) that dampens the force transmitted to the force sensor (1152), however, other sensor flanges (not shown) may have the force sensor directly underneath the load point.

[0150]

[0177] In some embodiments, the force sensor (1152) measures the force / pressure applied to the proximal end pad (132, see FIGS. 6-7) and mechanically transmitted to the force sensor (1152) as a resistance / impedance, which is processed, stored, and / or transmitted as a numerical data point. The sensor flange (1150), in some embodiments, measures the force measured according to the Hagen-Poiseuille equation: ΔΡ=8μLQ / πR 4 where ΔΡ is the pressure difference across the tubing, μ is the dynamic viscosity of the liquid being injected through the tubing, L is the length of the tubing (e.g., the length of the needle), R is the radius of the tubing (e.g., the radius of the needle), and Q is the flow rate of the liquid through the tubing. ΔΡ=force ("F") on the syringe cross-sectional area ("A"), and Q=dose ("D") over time ("t"), so the formula is ΔΡ=ΑDμL / πR 4 A, D, μ, L, and R are constants for a given dose in a given injection system, and can be expressed as ΑD8μL / πR 4 can be expressed in terms of a constant k. Thus, for two users injecting the same dose using the same injection system at different speeds, F1=k / t1 and F2=k / t2. In other words, when using the same injection system to inject the same dose, F×t is constant (i.e. = k). Thus, F1xt1=F2xt2, and doubling the force halves the injection time.

[0151]

[0178] Because a human user may not apply a constant force to the injection system (110), the processor in the sensor flange (1150) may be configured to calculate F×t for short injection intervals where the force is approximately constant. Figure 31 shows a series of such measurements in graph 1200. By integrating Fdt, the injection force can be approximated with a known cumulative sampling time to calculate F×t.

[0152]

[0179] 32 illustrates a method (1300) for determining completion of injection of a given dose using a given injection system, according to one embodiment. In step (1312), a processor in the sensor flange (1150) and / or a processor in an external computer (e.g., a smartphone) communicatively coupled to the sensor flange (1150) sets a cumulative F×t to zero. In step (1314), the processor waits one known sampling time (dt). In step (1316), the force sensor (1152) in the sensor flange (1150) measures / records an instantaneous force (F). In step (1318), the processor calculates F×dt, and in step (1320), the processor adds the calculated F×dt to the cumulative F×t. At step (1322), which does not necessarily occur after step (1320) but occurs prior to decision point (1324) described below, the processor determines or is provided with a target dose (i.e., target F×t). The target F×t is determined using the known A, D, μ, L, and R of the injection system (110). The target F×t may be affected by friction between the stopper member (114) and the syringe body (112). At decision point (1324), the processor calculates the difference between the target F×t and the accumulated F×t. If the difference is less than zero (i.e., the accumulated F×t has not yet reached the target F×t), the method (1300) returns to step (1314) to wait for another sampling time (dt). If the difference is greater than or equal to zero (i.e., the cumulative F×t reaches or exceeds the target F×t), the method (1300) proceeds to step (1326) where the processor sets the measured F×t equal to the cumulative F×t. In step (1328), the processor reports that the dose has been delivered. This dose delivery may be reported to a medical professional, a patient injecting at home, an electronic medical record, a smartphone app, a physician, a nurse, a caregiver, a health insurer, a clinical trial, a clinical trial administrator, a pharmaceutical distributor, a pharmaceutical company, etc.

[0153]

[0180] The method (1300) described above uses needle gauge (A and R) and length (L), among other system characteristics, to determine completion of dose delivery. The needle gauge and length may be entered into the processor by a user or caregiver (e.g., using a smartphone). Alternatively, the processor may empirically determine k=F×t upon first use of the injection system (110). A table of common needle sizes may be stored in the processor to facilitate this determination. In other embodiments, a manual calibration may be performed by the user to capture needle gauge and length, drug viscosity, dose, and / or other force sensor characteristics.

[0154]

[0181] The method (1300) described above uses the Hagen-Poiseuille equation to determine completion of dose delivery, which is more accurate with a needle that is free of turbulence. Thus, the sensor flange (1150) may be configured to detect / calculate injection characteristics indicative of turbulence. FIG. 33 is a graph (1400) of the force applied to the system (i.e., "thumb force") versus the total Fdt for injecting 1 cc (e.g., ml) of liquid through a half-inch, 27-gauge needle. The graph (1400) shows that if the thumb force is less than about 9 pounds, 40 lb-sec (1412) is required to complete the 1 cc injection. However, if the thumb force is greater than about 9 pounds (1414), more than 40 lb-sec (1412) is required to complete the 1 cc injection. Thus, the processor may use the instantaneous F×t calculated (e.g., as shown in method (1300)) to determine when the thumb force becomes too great and the flow becomes turbulent. Accordingly, the sensor flange (1150) may use a visual or audio indicator to indicate that the user should relax their thumb pressure to maintain non-turbulence and accuracy of the dose completion method (1300).

[0155]

[0182] The output devices (1155, 1156) communicate with the user (e.g., deliver various messages, signals, and / or alarms to the user). The sensor flange (1150) includes a display (1155) for visually communicating with the user. The display (1155) may communicate with binary (i.e., on / off) signals, color signals, etc. In other embodiments, the display function is performed by a display capable of displaying images. The sensor flange (1150) also includes a speaker (1156) for audibly communicating with the user. The speaker (1156) may communicate with binary (i.e., beep) tones, tonal tones, spoken text signals / messages (e.g., using pre-recorded and / or computer-generated voice), etc. Although the output devices (1155, 1156) are described as displays and / or speakers, various other output devices (e.g., haptics, etc.) may also be used with the sensor flange according to other embodiments. The sensor flange (1150) also includes a battery (1186) (eg, an inductively rechargeable battery) for powering its various electrical components.

[0156]

[0183] The attachment sensor (1158) may be a partially mechanical device (e.g., a switch) that has two states. The attachment sensor (1158) has an "unbound" state in which the attachment sensor (1158) is not depressed and protrudes from the surface of the sensor flange (1150) due to a biasing force (e.g., spring actuated). The attachment sensor (1158) also has a "bound" state in which the attachment sensor (1158) is depressed due to interaction with the outer surface of the syringe body (112) located in the opening (1162). The depressed attachment sensor (1158) sends a message to a processor (not shown) in the sensor flange (1150) to communicate that the sensor flange (1150) is removably coupled to the syringe body (112).

[0157]

[0184] While the sensor flange (1150) shown in FIG. 30 requires information about the injection system (110), other injection systems may determine completion of dose delivery with less information about the system. For example, the optical motion sensor (160) described above with reference to FIGS. 6-7 may include an optical system configured to detect and quantify the movement of the plunger member (116). In some embodiments, the distances traveled by the plunger member (116) are summed, and the sensor flange (150) determines that the full dose has been delivered when the summed distance is approximately the target distance (i.e., a distance sufficient for the stopper member (114) to reach the distal end (122) of the syringe body (112). In this embodiment, the only information about the injection system (110) required to determine dose delivery is the distance from the stopper member (114) to the distal end (122) of the syringe body (112).

[0158]

[0185] FIG. 34 shows an injection system (1510) according to another embodiment that also uses the travel distance of the stopper member (114) and the plunger member (116) coupled thereto to determine dose delivery completion. The injection system (1510) includes a sensor flange (1550) having an acoustic echo sensor (1588) such as the one (160) shown in FIG. 9. The acoustic echo sensor (1588) is configured to measure the distance between the acoustic echo sensor (1588) and a proximal end pad (132) coupled to the plunger member (116). When the distance between the acoustic echo sensor (1588) and the proximal end pad (132) reaches approximately the target distance (i.e., a distance sufficient for the stopper member (114) to reach the distal end (122) of the syringe body (112), the sensor flange (1550) determines that the full dose has been delivered. In this embodiment, the only information about the injection system (110) required to determine dose delivery is the distance from the stopper member (114) to the distal end (122) of the syringe body (112). Alternatively, an acoustic echo sensor (1588) may be directed toward the syringe body (112) to determine the distance to the stopper member (116). Alternatively, the function of the acoustic echo sensor (1588) may be performed by a laser range finder, a digital camera with autofocus, or a method for determining the position of the plunger member (114) and / or the stopper member (116) over time.

[0159]

[0186] Sensor flange 1550 also includes a slot 1590 configured to fixedly receive syringe flange 126 of syringe body 112 to secure sonic echo sensor 1588 relative to syringe body 112. Sensor flange 1550 also includes a display 1555 and a speaker 1556 that function as the output devices described above.

[0160]

[0187] 35 and 36 show an injection system (1610) according to yet another embodiment that also uses the distance traveled by a stopper member (114) and a plunger member (116) coupled thereto to determine dose delivery completion. The injection system (1610) includes a sensor flange (1650) having a roller sensor (1692) configured to measure the distance traveled by the plunger member (116). The sensor flange (1650) also includes slots (1690), (1655), and a speaker (1656), which are similar to the corresponding components shown in FIG. 34 and described above.

[0161]

[0188] When sensor flange (1650) is attached to syringe body (112) with syringe flange (126) in slot (1690), roller sensor (1692) contacts plunger member (116). This causes a wheel within roller sensor (1692) to rotate as plunger member (116) moves. An optical reader or mechanical sensor in roller sensor (1692) measures the rotation of the wheel therein, and a processor within or coupled to sensor flange (1650) determines the distance traveled by plunger member (116) from the measured rotation of the wheel. Although roller sensor (1692) shown in FIG. 36 is configured for use with plunger member (116) having an "X" shaped cross-section, other roller sensors may be configured for use with plunger members having other cross-sections.

[0162]

[0189] 37-40 show yet another embodiment of an injection system (1710) that also uses the travel distance of a stopper member (114) and a plunger member (116) coupled thereto to determine dose delivery completion. The injection system (1710) includes a sensor flange (1750) having a light sensor (1798) and a light directing optical element ("light pipe") (1794) configured to determine when the stopper member (114) intersects with a light beam emitted from the light sensor (1798) and passing through the light pipe (1794). The sensor flange (1750) also includes slots (1790), (1755), and a speaker (1756), which are similar to the corresponding components shown in FIG. 34 and described above.

[0163]

[0190] The optical sensor 1798 includes a light emitter and a light receiver and is optically coupled to a light pipe 1794. The light pipe 1794 includes an angled reflective surface 1796 configured to direct light in a direction perpendicular to the longitudinal axis of the syringe body 112. The optical sensor 1798 and light pipe 1794 are configured such that light from the light emitter of the optical sensor 1798 is directed toward the syringe body 112 and emitted light reflected by the syringe body 112 and the liquid contained therein is detected by the receiver of the optical sensor 1798. As shown in FIG. 39, in the pre-injection configuration, the stopper member 114 is positioned in the optical path defined by the angled reflective surface 1796. The dark color of the stopper member 114 reduces the reflected light that reaches the receiver of the optical sensor 1798. In contrast, in the post-injection configuration shown in FIG. 40 (i.e., when the stopper member (114) reaches the distal end (122) of the syringe body (112), the stopper member (114) has been moved beyond the optical path defined by the angled reflective surface (1796). As such, the amount of reflected light reaching the receiver of the optical sensor (1798) increases in the post-injection configuration. A processor in or coupled to the sensor flange (1750) can determine that the injection is complete based on this change in the intensity of the reflected light.

[0164]

[0191] 41-43 show an injection system (1810) according to yet another embodiment in which the distance traveled by the stopper member (114) and the associated plunger member (116) is also used to determine dose delivery completion. The injection system (1810) includes a sensor flange (1850) having an optical sensor (1898) configured to read / detect the marker (136), similar to the sensor (160, 1798) shown in FIGS. 8 and 38. The sensor flange (1850) also includes slots (1890), (1855), and a speaker (1856), similar to the corresponding components shown in FIG. 34 and described above.

[0165]

[0192] Similar to the optical sensor (1798) shown in FIG. 38, the optical sensor (1898) includes a light emitter and a light receiver. As shown in FIG. 42, in the pre-injection configuration, the marker (136) on the plunger member (116) is positioned away from the optical sensor (1898). In contrast, in the post-injection configuration shown in FIG. 43, the marker (136) is positioned in the optical path of the optical sensor (1898) such that the optical sensor (1898) can read the marker (136). Reading the marker (136) can include detecting differences in reflected light (e.g., see FIGS. 37-40 above) and / or optical character recognition. The marker (136) can be printed or molded into the plunger member (116) and can include injection information, such as an identifier for the injection system (1810), to enable tracking of drug delivery.

[0166]

[0193] The injection system (1810) shown in Figures 41-43 includes a sensor flange (1850) with an optical sensor (1898), however in other embodiments (not shown), the sensor may be a contact switch configured to be actuated by a rib or groove molded into the plunger member to signal / detect dose delivery completion.

[0167]

[0194] 44 illustrates a method (1900) of collecting injection information according to yet another embodiment. At step (1912), a sensor flange, such as the sensor flanges (150, 1150, 1650, 1750, 1850) described above, is removably coupled to a syringe body of an injection system. The injection system may be similar or identical to the injection systems (110, 1110, 1610, 1710, 1810) described above. The sensor flange may be secured to the syringe body using an interference fit.

[0168]

[0195] At step 1914, an injection is performed by manipulating a plunger member of the injection system, for example, using a finger of the user's hand (e.g., thumb) to apply a force against a proximal end pad of the plunger member while one or more other fingers of the user's hand provide a counter force (e.g., against the distal side of a syringe flange or a sensor flange disposed thereon).

[0169]

[0196] In step (1916), the sensor flange measures the injection characteristic using a sensor. The sensor can be any known type of sensor, including but not limited to acoustic sensors, motion sensors, proximity sensors, temperature sensors, force sensors (including sensor damping), acceleration sensors, orientation sensors, optical sensors, roller sensors, sonic echo sensors, and light sensors. The type of sensor can be selected to measure the type of injection characteristic required for method (1900).

[0170]

[0197] At step (1918), the sensor flange measures the time of the injection ("injection time"). The sensor flange may include an internal clock for measuring the injection time. The injection time may include the time duration of the injection and / or the time the injection begins and / or is completed.

[0171]

[0198] In step (1920), the sensor flange (i.e., a processor therein or coupled thereto) analyzes the injection characteristics and injection time to monitor (e.g., detect, measure, determine, etc.) an injection event (e.g., injection completion, plunger force, shear force, ejection error, etc.). The type of injection event monitored during method (1900) determines the type of injection characteristic measured by the type of sensor in the sensor flange.

[0172]

[0199] At step (1922), the sensor flange stores the post-injection data in the sensor flange's memory. The post-injection data includes, but is not limited to, measured injection characteristics and injection time, data related to the monitored injection event, F×t values ​​(cumulative and instantaneous), injection date and time, injection frequency, plunger force, time elapsed since injection, injection error related data, viscosity, temperature, warming time, shear force, residual drug remaining in the syringe, multiple injection site regimen data, rewards program data, and education / marketing data. Injection errors include, but are not limited to, drug identification errors, injection timing errors, dosage errors, shear force errors, degassing errors, residual drug remaining in the syringe, and multiple site injection errors.

[0173]

[0200] At step (1924), the sensor flange transmits the post-injection data to the computing device. The sensor flange may be communicatively connected to the computing device using a variety of communication devices, wired and / or wireless. Wireless communication devices include, but are not limited to, Bluetooth, WiFi, WiFi Direct, cellular, and near field communication. After the sensor flange establishes a communication link with the computing device, the sensor flange may download the post-injection data to the computing device. In one embodiment, the sensor flange stores the measured, collected, calculated, and generated post-injection data in memory and then downloads the post-injection data to the computing device in a batch / asynchronous manner. Computing devices that receive the post-injection data from the sensor flange include, but are not limited to, smartphones, computers, databases, cloud computing networks. The computing devices may be associated with medical professionals, home injection patients, electronic medical records, smartphone applications, doctors, nurses, caregivers, health insurance companies, clinical trials, clinical trial administrators, pharmaceutical distribution companies, pharmaceutical companies, and the like.

[0174] Smart Proximal Pad / Thumb Pad

[0201] 45 illustrates an injection system (2010) including a sensor proximal end pad ("thumb pad") (2074) for detecting injection characteristics and monitoring an injection event, as described above. The injection system (2010) also includes a syringe body (112), a stopper member (114), and a plunger member (116). The syringe body (112) includes an open proximal end (120) and an open distal end (122). The syringe body (112) also includes a syringe interior (124), a syringe flange (126) at its proximal end (120), and a coupling member (128) at its distal end (122) (e.g., for releasably attaching a second coupling member connected to a needle assembly or an IV bag). The stopper member (114) is disposed within the syringe interior (124) and coupled to a plunger member (116) that can be manipulated to distally insert the stopper member (114) and expel an injectable substance (e.g., a medical solution) from the syringe interior (124) through a coupling member (128). In the embodiment shown in FIG. 45, the coupling member (128) is a female luer connector capped with a luer cap (134) that is configured to form a fluid-tight connection / seal with a male luer connector (not shown). The plunger member (116) has a proximal end pad (132) for facilitating manual manipulation of the plunger member (116) using a finger (e.g., thumb) of a user's hand, with one or more other fingers of the user's hand providing a counter force (e.g., against the distal side of a syringe flange or a sensor flange disposed thereon).

[0175]

[0202] The sensor thumb pad (2074) is removably coupled to the proximal end pad (132) of the plunger member (116). The sensor thumb pad (2074) includes a force sensor (2076) configured to measure an injection force applied to the sensor thumb pad (2074) during an injection with the injection system (2010). The sensor thumb pad (2074) may also include a processor and / or a communication device (neither shown) for monitoring an injection event (e.g., complete injection of a dose) as described above. The sensor thumb pad (2074) may include other features as described above for the sensor flange, including, but not limited to, a display, a speaker, attachment sensors, and the like. The sensor thumb pad (2074) may include alternative and / or additional sensors, such as acoustic sensors, motion sensors, proximity sensors, temperature sensors, damping force sensors, acceleration sensors, orientation sensors, optical sensors, sonic echo sensors, light sensors, and the like.

[0176] Smart Plunger Rod

[0203] 18A and 18B show an injection system (910) having a one-way communication mode with a computing device. The injection system (910) includes a syringe body (912), a stopper member (914), a plunger member (916), and a needle assembly (918). The syringe body (912) includes an open proximal end (920) and an open distal end (922). The syringe body (912) also includes a syringe interior (924) and a syringe flange (926) at its proximal end (920). The stopper member (914) is disposed within the syringe interior (924) and is coupled to a plunger member (916) that can be manipulated to insert the stopper member (914) distally into the syringe interior and expel an injectable substance (e.g., a fluid) from the syringe interior (924) through a needle assembly (918). The needle assembly (918) is configured to be fixed to a distal end (922) of the syringe body (912). Alternatively, a user-attachable luer needle may be used. The needle assembly (918) has a needle (930) at its distal end. The plunger member (916) has a proximal end pad (932) that facilitates manual manipulation of the plunger member (916) using a finger of the user's hand (e.g., thumb) while one or more other fingers of the user's hand provide a counter force (e.g., against the distal side of or above the syringe flange (926)).

[0177]

[0204] The plunger member (916) also includes an RFID chip (938) (see FIGS. 21 and 22) and a pair of antennas (940). Prior to injection, the RFID chip (938) is deactivated, but upon injection, the RFID chip (938) activates and transmits post-injection information to an RFID receiver (see FIGS. 27-28B). This post-injection information may include, but is not limited to, information identifying the injection system (910) and indicating that an injection using the injection system (910) has been completed. Alternatively, the RFID chip (938) may communicate bidirectionally with a computing device. Upon injection, the computing device scans for the presence of an activated RFID chip to identify an injection completion event. The RFID chip (938) is then instructed by the computing device to deactivate / self-destruct, thereby preventing the RFID chip (938) from being accidentally read a second time by the computing device.

[0178]

[0205] Figures 19 and 20 show the plunger member (916) of the injection system (910) shown in Figures 18A and 18B. Figure 19 shows that an antenna (940) is disposed within the plunger member (916). Figure 20 shows that the antenna (940) is physically and functionally coupled to an RFID chip (938) disposed at the proximal end of the plunger member (916) and covered by a proximal end pad (932).

[0179]

[0206] Figure 21 shows an RFID chip (938) and antenna (940) combination according to one embodiment that can be used in the injection system shown in Figures 18A-20. The antenna (940) is electrically and operably coupled to the RFID chip (938). Because electricity tends to flow along the path of least resistance, the RFID chip (938) includes a shunt (942) that diverts power from the RFID chip (938). Diverting power from the RFID chip (938) deactivates the chip.

[0180]

[0207] Figure 22 shows the inside of the proximal end cap (932) of the plunger member (916) for use with the RFID chip (938) and antenna (940) combination shown in Figure 21. The proximal end cap (932) includes a cutting member (944) configured to sever the shunt (942) when a force is applied to the proximal end (932) to move the plunger member (916) in a distal direction. Cutting the shunt (942) activates the RFID chip (938) by directing power to the chip. The activated RFID chip (938) can transmit data to an RFID receiver as previously described.

[0181]

[0208] Figures 23A and 23B show that the proximal end cap (932) of the plunger member (916) shown in Figure 22 is movable along the longitudinal axis of the plunger member (916). Figure 23A shows the proximal end cap (932) in a pre-injection position where the cutting member (944) does not contact the shunt (942) within the RFID chip (938). Figure 23B shows the proximal end cap (932) in a post-injection position where the cutting member (944) cuts the shunt (942), thereby activating the RFID chip (938). Figure 24 shows an activated RFID chip (938) with the shunt (942) cut.

[0182]

[0209] Figure 25 shows an RFID chip (938) and corresponding helical antenna (940), which is configured to be placed at the proximal end (932) of the plunger member (916) for use with the injection systems shown in Figures 18A-20. The RFID chip (938) includes a gap (946) that prevents power from being supplied to the RFID chip (938) until the gap (946) is bridged to complete a circuit.

[0183]

[0210] FIG. 26 shows the inside of a proximal end cap (932) of a plunger member (916) for use with the RFID chip (938) and helical antenna (940) combination shown in FIG. 25. The proximal end cap (932) includes a conductive member (948) configured to bridge a gap (946) when a force is applied to the proximal end (932) to move the plunger member (916) in a distal direction. Bridging the gap (946) activates the RFID chip (938) by providing power to the chip. The activated RFID chip (938) can transmit data to an RFID receiver as previously described. The proximal end cap (932) of the plunger member (916) shown in FIG. 26 is movable along the longitudinal axis of the plunger member (916) as shown in FIGS. 23A and 23B.

[0184]

[0211] Figure 27 shows a smartphone including RFID receiver functionality and applications. Figures 28A and 28B show a phone cover having an RFID receiver configured to be operatively coupled to a smartphone within the phone cover.

[0185]

[0212] Figure 29 illustrates a method (1000) for transmitting injection information using an RFID chip according to one embodiment. At step (1012), an injection system is provided, such as that shown in Figures 18A-28B, which includes an RFID chip in an inactive state.

[0186]

[0213] At step (1014), the plunger member of the injection system is manipulated to perform the injection, for example, using a finger of the user's hand (e.g., thumb) to exert a force on the proximal end pad of the plunger member while one or more other fingers of the user's hand provide a counter force (e.g., against the distal side of a syringe flange or a sensor flange disposed thereon).

[0187]

[0214] At step 1016, the proximal end pad is moved distally relative to the plunger member. As shown in Figures 23A and 23B, applying a distal force to the proximal end pad can cause the proximal end pad to move distally.

[0188]

[0215] In step (1018), the RFID tag is activated. In the embodiment shown in Figures 18A-24, the RFID tag is activated by breaking the shunt. In the embodiment shown in Figures 25 and 26, the RFID tag is activated by filling the gap. However, other methods of activating a previously deactivated RFID tag are also included in this step (1018).

[0189]

[0216] At step (1020), the activated RFID tag communicates with the RFID receiver to communicate post-injection information to the RFID receiver and a computing device operatively coupled thereto. This post-injection information may include, but is not limited to, information identifying the injection system (910) and indicating that an injection was completed using the injection system (910). The post-injection information may be used to track patient compliance, facilitate reward programs, inform insurance programs, etc.

[0190]

[0217] The present invention also relates to the following items / embodiments:

[0191]

[0218] 1. A system for metering an injection of a medical solution, comprising:

[0219] a syringe body having a proximal end and a distal end, a syringe interior, and a syringe flange at the proximal end;

[0220] a stopper member disposed inside the syringe;

[0221] a plunger member coupled to the stopper member and configured to be manipulated relative to the syringe body to insert the stopper member distally into the syringe interior;

[0222] a needle coupled to a distal end of the syringe body;

[0223] and a sensor flange removably coupled to the syringe body, the sensor flange comprising:

[0224] a sensor for measuring an injection characteristic;

[0225] and a processor that analyzes the injection characteristics to determine the occurrence of an injection event.

[0192]

[0226] 2. The system of embodiment 1, wherein the injection event is an injection of a dose of a medical solution.

[0193]

[0227] 3. The system of embodiment 2, wherein the sensor is a force sensor and the injection characteristic is a force applied to the plunger member.

[0194]

[0228] 4. The system of embodiment 3, wherein the processor calculates the force-time product of the injection of the dose of the medical solution.

[0195]

[0229] 5. The system of embodiment 2, wherein the sensor is an optical sensor and the injection characteristic is a position, velocity, or acceleration of a plunger member.

[0196]

[0230] 6. The system of embodiment 5, wherein the optical sensor is an IR sensor.

[0197]

[0231] 7. The system of embodiment 5, wherein the plunger member includes a visual feature that is read by an optical sensor.

[0198]

[0232] 8. The system of embodiment 2, wherein the sensor is an acoustic sensor and the injection characteristic is a position, velocity, or acceleration of a plunger member.

[0199]

[0233] 9. The system of embodiment 8, wherein the acoustic sensor is an acoustic reflection sensor configured to measure the distance from the sensor to a proximal end pad of the plunger member.

[0200]

[0234] 10. The system of embodiment 8, wherein the acoustic sensor is an acoustic reflection sensor configured to measure a distance from the sensor to the stop member.

[0201]

[0235] 11. The system of embodiment 2, wherein the sensor is a mechanical sensor and the injection characteristic is a position, velocity, or acceleration of a plunger member.

[0202]

[0236] 12. The system of embodiment 11, wherein the mechanical sensor is:

[0237] a roller in contact with an outer surface of the plunger member;

[0238] and a reader for measuring the rotation of the roller.

[0203]

[0239] 13. The system of embodiment 12, wherein the reader is an optical sensor or a mechanical sensor.

[0204]

[0240] 14. In the system of embodiment 11,

[0241] the mechanical sensor comprises a contact switch;

[0242] The plunger member includes a mechanism for actuating a contact switch;

[0243] The injection characteristic is a position of a plunger member.

[0205]

[0244] 15. The system of embodiment 2, wherein the sensor is an optical sensor, and the system further comprises:

[0245] A light source;

[0246] a light guiding optical element for guiding light from the light source and reflected light to an optical sensor;

[0247] The injection characteristic is a position of a stopper member.

[0206]

[0248] 16. The system of embodiment 1, wherein the sensor flange is removably coupled to the syringe body at least partially distal to the syringe flange.

[0207]

[0249] 17. The system of embodiment 1, wherein the sensor is a first sensor and the injection characteristic is a first injection characteristic;

[0250] The system, wherein the sensor flange further comprises a second sensor for measuring a second injection characteristic.

[0208]

[0251] 18. The system of embodiment 1, wherein the sensor flange is configured to be manipulated relative to the syringe body to insert a stopper member distally into the syringe interior.

[0209]

[0252] 19. The system of embodiment 18, wherein the plunger member includes a proximal end pad that is manipulated simultaneously with the sensor flange to insert the stopper member distally into the syringe interior relative to the syringe body.

[0210]

[0253] 20. The system of embodiment 2, wherein the sensor flange further includes an attachment sensor for detecting when the sensor flange is removably coupled to the syringe body;

[0254] the sensor flange is configured to generate an alarm upon completion of injection of a dose of medical fluid to prevent premature disposal of the sensor flange;

[0255] A system where an alarm is silenced if an attachment sensor indicates that the finger flange has been removed from the syringe body.

[0211]

[0256] 21. The system of embodiment 20, wherein the attached sensor comprises a mechanical switch.

[0212]

[0257] 22. The system of embodiment 1, wherein the sensor flange further includes one or more of a battery, a speaker, an indicator light, a clock, a calendar, non-volatile computer memory, a tactile feedback device, and a display device.

[0213]

[0258] 23. The system of embodiment 4, wherein the sensor flange is configured to compare a measured force-time product to a reference force-time product to identify the occurrence of an injection event.

[0214]

[0259] 24. The system of embodiment 23, wherein the sensor flange is configured to record the date and time of an injection event.

[0215]

[0260] 25. The system of embodiment 23, wherein the reference force-time product is predetermined based on the viscosity of the medicinal solution to be injected and the size of the needle.

[0216]

[0261] 26. The system of embodiment 1, wherein the sensor flange further includes a display for communicating information to a user administering an injection.

[0217]

[0262] 27. The system of embodiment 26, wherein the display warns the user if the injection is performed too quickly or too slowly.

[0218]

[0263] 28. The system of embodiment 1, wherein the sensor flange further includes a speaker that generates an audible sound to communicate with a user administering an injection.

[0219]

[0264] 29. The system of embodiment 28, wherein the speaker alerts the user if the injection is performed too quickly or too slowly.

[0220]

[0265] 30. The system of embodiment 1, wherein the sensor flange further comprises one or more output devices that deliver a calendar, a clock, and an audible, visual, and / or tactile alarm to indicate when it is time for an injection.

[0221]

[0266] 31. The system of embodiment 1, wherein the sensor flange is configured with a computer network communication protocol for communicating that an injection event has occurred.

[0222]

[0267] 32. The system of embodiment 31, wherein the sensor flanges communicate intermittently / asynchronously or constantly.

[0223]

[0268] 33. The system of embodiment 1, wherein the sensor flange further comprises a calendar and clock, and wherein the sensor flange stores the date and time of the occurrence of an injection event in non-volatile memory as injection event data.

[0224]

[0269] 34. The system of embodiment 33, wherein the injection event data further includes F×t product, injection execution indicator, temperature, speed, pressure, and ejection into air / injection into patient indicator.

[0225]

[0270] 35. The system of embodiment 33, wherein the stored injection event data is transmitted when network communication is established between the sensor flange and a computer network.

[0226]

[0271] 36. The system of embodiment 31, wherein the sensor flange transmits injection event data to one or more of a smartphone, a computer, a database, a cloud computing network, a medical professional, a home injection patient, an electronic medical record, a smartphone application, a doctor, a nurse, a caregiver, a health insurance company, a clinical trial, a clinical trial administrator, a pharmaceutical distribution company, and a pharmaceutical manufacturer.

[0227]

[0272] 37. The system of embodiment 1, wherein the sensor flange further comprises an output device that generates an alarm when turbulence is detected in the system.

[0228]

[0273] 38. A method for measuring an injection of a liquid medicine, comprising:

[0274] Removably coupling the sensor flange to a syringe body of an injection system, the syringe body having proximal and distal ends, a syringe interior, and a syringe flange at its proximal end, the injection system comprising:

[0275] A stopper member disposed inside the syringe;

[0276] a plunger member connected to the stopper member;

[0277] a needle coupled at its distal end to the syringe body;

[0278] the sensor flange including a sensor and a processor;

[0279] manipulating the plunger member to insert a stopper member distally into the syringe body to perform an injection;

[0280] measuring an injection characteristic using a sensor on the sensor flange;

[0281] and analyzing an injection characteristic using a processor in the sensor flange to monitor an injection event.

[0229]

[0282] 39. The method of embodiment 38, wherein the injection event is the injection of a dose of a medical solution.

[0230]

[0283] 40. The method of embodiment 39, wherein the sensor is a force sensor and the injection characteristic is a force applied to a plunger member.

[0231]

[0284] 41. The method of embodiment 40, further comprising the step of the processor calculating a force-time product of injection of a dose of the medicinal solution.

[0232]

[0285] 42. The method of embodiment 39, wherein the sensor is an optical sensor and the injection characteristic is a position, velocity, or acceleration of a plunger member.

[0233]

[0286] 43. The method of embodiment 42, wherein the optical sensor is an IR sensor.

[0234]

[0287] 44. The method of embodiment 42, wherein the plunger member is provided with a visual feature, and further comprising the step of the optical sensor reading the visual feature.

[0235]

[0288] 45. The method of embodiment 39, wherein the sensor is an acoustic sensor and the injection characteristic is a position, velocity, or acceleration of a plunger member.

[0236]

[0289] 46. ​​The method of embodiment 45, wherein the acoustic sensor is an acoustic reflective sensor, and further comprising the step of the acoustic reflective sensor measuring a distance from the sensor to a proximal end pad on the plunger member.

[0237]

[0290] 47. The method of embodiment 45, wherein the acoustic sensor is an acoustic reflective sensor, and further comprising the step of the acoustic reflective sensor measuring a distance from the sensor to a stop member.

[0238]

[0291] 48. The method of embodiment 39, wherein the sensor is a mechanical sensor and the injection characteristic is a position, velocity, or acceleration of a plunger member.

[0239]

[0292] 49. The method of embodiment 48, wherein the mechanical sensor comprises:

[0293] a roller in contact with an outer surface of the plunger member;

[0294] Equipped with leaders,

[0295] The method further comprising the step of the reader measuring rotation of the roller.

[0240]

[0296] 50. The method of embodiment 49, wherein the reader is an optical sensor or a mechanical sensor.

[0241]

[0297] 51. In the method of embodiment 48,

[0298] the mechanical sensor includes a contact switch;

[0299] the plunger member includes a feature;

[0300] the injection characteristic being a position of a plunger member;

[0301] The method further comprising the step of the feature activating the contact switch.

[0242]

[0302] 52. In the method of embodiment 39,

[0303] the sensor is an optical sensor;

[0304] The injection system further comprises

[0305] A light source;

[0306] A light-guiding optical element;

[0307] the injection characteristic being a position of a stopper member;

[0308] The method further includes the step of the light directing optical element directing light from a light source and reflected light to a light sensor.

[0243]

[0309] 53. The method of embodiment 38, wherein the sensor flange is removably coupled to the syringe body at least partially distal to the syringe flange.

[0244]

[0310] 54. In the method of embodiment 38,

[0311] the sensor is a first sensor and the injection characteristic is a first injection characteristic;

[0312] the sensor flange further includes a second sensor;

[0313] The method further includes the step of the second sensor measuring a second injection characteristic.

[0245]

[0314] 55. The method of embodiment 38, further comprising the step of manipulating the sensor flange to insert a stopper member distally into the syringe interior relative to the syringe flange.

[0246]

[0315] 56. The method of embodiment 55, wherein the plunger member includes a proximal end pad, and further comprising the step of manipulating the proximal end pad simultaneously with the sensor flange to distally insert the stopper member into the syringe interior relative to the syringe body.

[0247]

[0316] 57. The method of embodiment 39, wherein the sensor flange further includes an attached sensor, and the method further comprises:

[0317] the attachment sensor detecting that a sensor flange is removably coupled to a syringe body;

[0318] the sensor flange issues an alarm when the injection of the drug solution is completed to prevent the sensor flange from being prematurely discarded;

[0319] and the sensor flange silencing an alarm when the attachment sensor indicates that a finger flange has been removed from the syringe body.

[0248]

[0320] 58. The method of embodiment 57, wherein the attached sensor includes a mechanical switch.

[0249]

[0321] 59. The method of embodiment 38, wherein the sensor flange further comprises one or more of a battery, a speaker, an indicator light, a clock, a calendar, non-volatile computer memory, a tactile feedback device, and a display device.

[0250]

[0322] 60. The method of embodiment 41, further comprising the step of the sensor flange comparing a measured force-time product to a reference force-time product to determine the occurrence of an injection event.

[0251]

[0323] 61. The method of embodiment 60, wherein the sensor flange further comprises a step of recording the time and date of the occurrence of an injection event.

[0252]

[0324] 62. The method of embodiment 60, wherein the reference force-time product is predetermined based on the viscosity of the medicinal solution to be injected and the size of the needle.

[0253]

[0325] 63. The method of embodiment 38, wherein the sensor flange further comprises a display, the display further comprising the step of conveying information to a user administering an injection.

[0254]

[0326] 64. The method of embodiment 63, further comprising the step of the display alerting the user if the injection is performed too quickly or too slowly.

[0255]

[0327] 65. The method of embodiment 38, wherein the sensor flange further includes a speaker, and the method further includes the step of the speaker generating an audible sound for communication with a user performing an injection.

[0256]

[0328] 66. The method of embodiment 65, comprising a step in which the speaker alerts the user if the injection is performed too quickly or too slowly.

[0257]

[0329] 67. The method of embodiment 38, wherein the sensor flange further comprises one or more output devices for emitting a calendar, a clock, and an audible, visual, and / or tactile alarm, and the method includes a step in which the sensor flange indicates when it is time for an injection.

[0258]

[0330] 68. The method of embodiment 38, further comprising the step of the sensor flange communicating with a computer network communication protocol that an injection event has occurred.

[0259]

[0331] 69. The method of embodiment 68, further comprising the step of the sensor flange communicating intermittently / asynchronously or constantly.

[0260]

[0332] 70. The method of embodiment 38, wherein the sensor flange further includes a calendar and clock, and wherein the sensor flange stores the date and time of the occurrence of an injection event in non-volatile memory as injection event data.

[0261]

[0333] 71. The method of embodiment 70, wherein the injection event data further includes an F×t product, an injection execution indicator, temperature, speed, pressure, and a spray-into-air / injection-into-patient indicator.

[0262]

[0334] 72. The method of embodiment 70, further comprising the step of transmitting stored injection event data when network communication is established between the sensor flange and a computer network.

[0263]

[0335] 73. The method of embodiment 68, further comprising a step in which the sensor flange transmits the injection event data to one or more of a smartphone, a computer, a database, a cloud computing network, a medical professional, a home injection patient, an electronic medical record, a smartphone application, a doctor, a nurse, a caregiver, a health insurance company, a clinical trial, a clinical trial administrator, a drug distribution company, or a pharmaceutical company.

[0264]

[0336] 74. The method of embodiment 38, wherein the sensor flange further comprises an output device, and the method further comprises the step of the output device generating an alarm when turbulence is detected within the injection system.

[0265]

[0337] 75. In the injection system,

[0338] a syringe body having a proximal end and a distal end, a syringe interior, and a syringe flange at the proximal end;

[0339] a stopper member disposed inside the syringe;

[0340] a plunger member coupled to the stopper member and configured to be manipulated relative to the syringe body to distally insert the stopper member into the syringe interior;

[0341] a needle coupled to a distal end of the syringe body;

[0342] a sensor flange removably coupled to the syringe body at least partially distal to the syringe flange, the sensor flange comprising:

[0343] a first sensor and a second sensor for measuring a first injection characteristic and a second injection characteristic, respectively;

[0344] and a processor that analyzes the first and second injection characteristics to monitor an injection event.

[0266]

[0345] 76. In the system of embodiment 75,

[0346] the first sensor is a force sensor and the first injection characteristic is an injection back pressure;

[0347] The system, wherein the second sensor is a motion sensor and the second injection characteristic is a movement of a plunger member.

[0267]

[0348] 77. The system of embodiment 76, wherein the injection event is an ejection into air.

[0268]

[0349] 78. The system of embodiment 77, wherein the sensor flange further comprises an orientation sensor for measuring orientation, and the processor analyzes the orientation to identify the ejection into the air.

[0269]

[0350] 79. The system of embodiment 76, wherein the injection event is needle occlusion.

[0270]

[0351] 80. The system of embodiment 76, wherein the injection event is a leak from the injection system.

[0271]

[0352] 81. The system of embodiment 75, wherein the sensor flange is configured to be manipulated to distally insert the stopper member into the syringe interior relative to the syringe body.

[0272]

[0353] 82. The system of embodiment 81, wherein the plunger member includes a proximal end pad that is operated simultaneously with the sensor flange to insert the stopper member distally into the syringe interior relative to the syringe body.

[0273]

[0354] 83. The system of embodiment 75, wherein the sensor flange further includes an attachment sensor for detecting when the sensor flange is removably coupled to the syringe body.

[0274]

[0355] 84. The system of embodiment 83, wherein the attached sensor includes a mechanical switch.

[0275]

[0356] 85. The system of embodiment 75, wherein the first and second sensors are selected from the group consisting of an acoustic sensor, a motion sensor, a proximity sensor, a temperature sensor, a force sensor, an accelerometer sensor, an orientation sensor, and an optical sensor.

[0276]

[0357] 86. The system of embodiment 85, wherein the motion sensor measures the position, velocity, or acceleration of the plunger member.

[0277]

[0358] 87. The system of embodiment 85, wherein the motion sensor is an optical sensor.

[0278]

[0359] 88. The system of embodiment 87, wherein the optical sensor is an IR sensor.

[0279]

[0360] 89. The system of embodiment 87, wherein the plunger member includes an identifier that is read by an optical sensor.

[0280]

[0361] 90. The system of embodiment 89, wherein the identifier includes data selected from the group consisting of drug name, drug dosage, serial number, and expiration date.

[0281]

[0362] 91. The system of embodiment 85, wherein the motion sensor is a laser motion sensor.

[0282]

[0363] 92. The system of embodiment 85, wherein the acoustic sensor includes an ultrasonic transducer.

[0283]

[0364] 93. The system of embodiment 85, wherein the temperature sensor measures the temperature of the injectable substance inside the syringe.

[0284]

[0365] 94. The system of embodiment 93, wherein the processor calculates an approximate time for the injectable substance to reach an injection temperature based at least in part on the measured temperature.

[0285]

[0366] 95. The system of embodiment 93, wherein the sensor flange further comprises an output device that emits an alarm signal when the measured temperature reaches the injection temperature.

[0286]

[0367] 96. The system of embodiment 75, wherein the sensor flange further comprises a battery.

[0287]

[0368] 97. The system of embodiment 75, wherein the sensor flange further includes a memory module.

[0288]

[0369] 98. The system of embodiment 75, wherein the sensor flange further includes a wireless communication device.

[0289]

[0370] 99. The system of embodiment 98, wherein the wireless communication device is a Bluetooth communication device.

[0290]

[0371] 100. The system of embodiment 98, wherein the wireless communication device is a WiFi or WiFi Direct communication device.

[0291]

[0372] 101. The system of embodiment 98, wherein the wireless communication device is a cellular communication device.

[0292]

[0373] 102. The system of embodiment 98, wherein the sensor flange is configured to receive injection setting data via a wireless communication device.

[0293]

[0374] 103. The system of embodiment 102, wherein the injection setting data includes data selected from the group consisting of current date and time, first injection date and time, injection frequency, syringe type, viscosity, temperature, warming time, maximum shear force, multi-injection site regimen data, rewards program data, and education / marketing data.

[0294]

[0375] 104. The system of embodiment 98, wherein the sensor flange is configured to transmit post-injection data to a computing device via a wireless communication device.

[0295]

[0376] 105. The system of embodiment 104, wherein the post-injection data includes data selected from the group consisting of injection date and time, injection frequency, plunger force, injection elapsed time, injection error related data, viscosity, temperature, warming time, shear force, residual drug remaining in the syringe, regimen data for multiple injection sites, reward program data, and education / marketing data.

[0296]

[0377] 106. The system of embodiment 105, wherein the injection error is selected from the group consisting of drug identification error, injection timing error, dosage error, shear force error, degassing error, residual drug remaining in the syringe, and multiple site injection error.

[0297]

[0378] 107. The system of embodiment 75, wherein the sensor flange further includes an output device.

[0298]

[0379] 108. The system of embodiment 107, wherein the output device is a speaker.

[0299]

[0380] 109. The system of embodiment 107, wherein the output device is a light source.

[0300]

[0381] 110. The system of embodiment 107, wherein the output device is a display device.

[0301]

[0382] 111. The system of embodiment 75, wherein the sensor flange further includes a clock.

[0302]

[0383] 112. The system of embodiment 111, wherein the sensor flange further comprises an output device that delivers an alarm signal.

[0303]

[0384] 113. The system of embodiment 112, wherein the alarm signal is delivered when an injection is due.

[0304]

[0385] 114. The system of embodiment 113, wherein the alarm signal is an audible alarm signal.

[0305]

[0386] 115. The system of embodiment 113, wherein the alarm signal is a visible alarm signal.

[0306]

[0387] 116. The system of embodiment 112, wherein an alarm signal is delivered until the sensor flange is coupled to the syringe body.

[0307]

[0388] 117. The system of embodiment 112, wherein an alarm signal is sent when the sensor flange detects an injection error.

[0308]

[0389] 118. The system of embodiment 117, wherein the injection error is selected from the group consisting of drug identification error, injection timing error, dosage error, shear force error, degassing error, residual drug remaining in the syringe, and multiple site injection error.

[0309]

[0390] 119. The system of embodiment 112, wherein an alarm signal is delivered if the sensor flange is not removed from the syringe body within a predetermined time after the injection is completed.

[0310]

[0391] 120. The system of embodiment 75, wherein the sensor flange is configured to slide along the longitudinal axis of the syringe body when the sensor flange is removably coupled to the syringe body.

[0311]

[0392] 121. In a method for collecting information about injections,

[0393] Removably coupling the sensor flange to a syringe body of an injection system, the injection system comprising:

[0394] a syringe body having a proximal end and a distal end, a syringe interior, and a syringe flange at the proximal end;

[0395] A stopper member disposed inside the syringe;

[0396] a plunger member connected to the stopper member;

[0397] a needle coupled to a distal end of the syringe body;

[0398] Manipulating the plunger member to insert a stopper member distally within the syringe relative to the syringe body to perform an injection.

[0399] measuring first and second injection characteristics, respectively, using the sensor flange;

[0400] and analyzing the first and second injection characteristics to monitor the injection event;

[0401] The method, wherein the sensor flange is removably coupled to a syringe body at least partially distal to the syringe flange.

[0312]

[0402] 122. The method of embodiment 121, wherein the sensor flange is:

[0403] Clock and

[0404] An output device;

[0405] A wireless communication device;

[0406] A memory module;

[0407] First and second sensors;

[0408] a processor;

[0409] The method, wherein measuring first and second injection characteristics using the sensor flange includes a first sensor measuring a first injection characteristic and a second sensor measuring a second injection characteristic.

[0313]

[0410] 123. In the method of embodiment 122,

[0411] the first sensor is a force sensor and the first injection characteristic is an injection back pressure;

[0412] The method, wherein the second sensor is a motion sensor and the second injection characteristic is a movement of a plunger member.

[0314]

[0413] 124. The method of embodiment 123, wherein the injection event is a squirt into air, and the method further comprises the step of detecting the squirt into air when the injection backpressure is substantially zero when the movement of the plunger member is non-zero.

[0315]

[0414] 125. The method of embodiment 124, wherein the sensor flange further comprises an orientation sensor for measuring orientation, and the method further comprises the step of the processor analyzing the orientation to identify an ejection into the air.

[0316]

[0415] 126. The method of embodiment 123, wherein the injection event is needle occlusion, and the method further comprises the step of detecting needle occlusion when injection backpressure increases while the movement of the plunger member is substantially zero.

[0317]

[0416] 127. The method of embodiment 123, wherein the injection event is a leak from the injection system, and the method further comprises the step of detecting a leak from the injection system when the injection backpressure is decreasing as the movement of the plunger member is increasing.

[0318]

[0417] 128. In the method of embodiment 122,

[0418] the clock reaching an injection time;

[0419] and the processor instructing an output device to output an alarm signal indicative of the time of injection.

[0319]

[0420] 129. The method of embodiment 128, wherein the alarm signal is an audible alarm signal.

[0320]

[0421] 130. The method of embodiment 128, wherein the alarm signal is a visible alarm signal.

[0321]

[0422] 131. The method of embodiment 128, further comprising a processor that instructs an output device to terminate delivery of the alarm signal in response to the sensor flange being removably coupled to the syringe body.

[0322]

[0423] 132. The method of embodiment 128, further comprising the step of the processor instructing the output device to terminate delivery of the alarm signal after a first predetermined time and to resume delivery of the alarm signal after a second predetermined time.

[0323]

[0424] 133. The method of embodiment 128, further comprising the step of the processor instructing an output device to terminate delivery of the alarm signal and deliver a message regarding the missed dose after a first predetermined time.

[0324]

[0425] 134. In the method of embodiment 122,

[0426] providing power to a wireless communication device;

[0427] and the wireless communication device attempting to establish a connection with a computing device.

[0325]

[0428] 135. The method of embodiment 134, further comprising the step of the wireless communication device establishing a connection with a computing device.

[0326]

[0429] 136. The method of embodiment 135, further comprising a step in which the sensor flange receives injection setting data from a computing device via a wireless communication device.

[0327]

[0430] 137. The method of embodiment 136, wherein the injection setting data includes data selected from the group consisting of current date and time, first injection date and time, injection frequency, syringe type, viscosity, temperature, warming time, maximum shear force, multi-injection site regimen data, rewards program data, and education / marketing data.

[0328]

[0431] 138. The method of embodiment 122, further comprising storing the measured first and second characteristics in a memory module.

[0329]

[0432] 139. In the method of embodiment 138,

[0433] establishing a connection with a computing device by the wireless communication device;

[0434] the sensor flange transmitting the measured characteristic to a computing device using a wireless communication device.

[0330]

[0435] 140. The method of embodiment 122, further comprising the step of storing post-injection data in a memory module.

[0331]

[0436] 141. The method of embodiment 140, wherein the post-injection data includes data selected from the group consisting of injection date and time, injection frequency, plunger force, injection elapsed time, injection error related data, viscosity, temperature, warming time, shear force, residual drug remaining in the syringe, multiple injection site regimen data, rewards program data, and education / marketing data.

[0332]

[0437] 142. The system of embodiment 141, wherein the injection error is selected from the group consisting of drug identification error, injection timing error, dosage error, shear force error, degassing error, residual drug remaining in the syringe, and multiple site injection error.

[0333]

[0438] 143. In the method of embodiment 140,

[0439] establishing a connection with a computing device by the wireless communication device;

[0440] and the sensor flange transmitting post-injection data to a computing device using a wireless communication device.

[0334]

[0441] 144. The method of embodiment 122, wherein the sensor flange further comprises an attachment sensor, and the attachment sensor further comprises detecting a coupling status of the sensor flange to the syringe body.

[0335]

[0442] 145. In the method of embodiment 144,

[0443] a sensor flange detecting an injection;

[0444] a clock measuring a predetermined time after the detected injection;

[0445] and when a coupling condition indicates that the sensor flange is coupled to a syringe body at a predetermined time, the processor instructs an output device to output an alarm signal.

[0336]

[0446] 146. The method of embodiment 144, further comprising the step of placing the sensor flange in a low power mode if the coupling status indicates that the sensor flange is not coupled to the syringe body.

[0337]

[0447] 147. The method of embodiment 146, wherein the step of placing the sensor flange in a low power mode includes the step of shutting off output devices and wireless communication devices and intermittently measuring characteristics to identify the coupling status of the sensor flange to the syringe body.

[0338]

[0448] 148. The method of embodiment 123, further comprising the processor calculating a shear force on the injectable material within the syringe based at least in part on the movement of the plunger member and the injection backpressure.

[0339]

[0449] 149. The method of embodiment 148, further comprising a processor that instructs an output device to send an alarm signal when the calculated shear force exceeds a predetermined maximum shear force.

[0340]

[0450] 150. The method of embodiment 122, wherein the first sensor is a motion sensor and the first injection characteristic is a velocity of the plunger member.

[0341]

[0451] 151. The method of embodiment 150, further comprising the step of a processor instructing an output device to issue a speed warning when the speed of the plunger member is outside a predetermined range.

[0342]

[0452] 152. The method of embodiment 151, wherein the speed warning indicates that the speed of the plunger member is below a predetermined range.

[0343]

[0453] 153. The method of embodiment 151, wherein the speed warning indicates that the speed of the plunger member is outside a predetermined range.

[0344]

[0454] 154. The method of embodiment 122, wherein the injection event is completion of an injection, and the method further comprises the step of the processor instructing an output device to deliver a message of administration to multiple sites.

[0345]

[0455] 155. The method of embodiment 154, wherein the first injection characteristic includes a sound indicating completion of the injection.

[0346]

[0456] 156. The method of embodiment 122, wherein the first and second sensors are selected from the group consisting of an acoustic sensor, a motion sensor, a proximity sensor, a temperature sensor, a force sensor, an accelerometer sensor, an orientation sensor, and an optical sensor. Sensor.

[0347]

[0457] 157. The method of embodiment 156, further comprising the step of the processor generating a force profile.

[0348]

[0458] 158. The method of embodiment 157, further comprising the processor determining that the injection is complete if the force profile includes a sudden increase in force.

[0349]

[0459] 159. The method of embodiment 156, further comprising the step of the processor determining that the injection was successful if the measured distance traveled by the plunger rod is equal to a predetermined value.

[0350]

[0460] 160. The method of embodiment 156, further comprising the step of the processor calculating an approximate time for the injectable substance to reach an injection temperature based at least in part on the measured temperature.

[0351]

[0461] 161. The method of embodiment 160, further comprising the step of the processor instructing an output device to send an alarm signal when the measured temperature reaches the injection temperature.

[0352]

[0462] 162. The method of embodiment 156, wherein the processor determines that the injection is successful when the measured acceleration of the plunger member falls to substantially zero.

[0353]

[0463] 163. The method of embodiment 122, further comprising the step of the processor instructing an output device to send an alarm signal when the sensor flange detects an injection error.

[0354]

[0464] 164. The method of embodiment 163, wherein the injection error is selected from the group consisting of drug identification error, injection timing error, dosage error, shear force error, degassing error, residual drug remaining in the syringe, and multiple site injection error.

[0355]

[0465] 165. The method of embodiment 122, further comprising the step of removing the sensor flange from the syringe after the injection is completed.

[0356]

[0466] 166. The method of embodiment 121, further comprising the step of sliding the sensor flange along the longitudinal axis of the syringe body until the sensor flange contacts the syringe flange of the syringe body when the sensor flange is removably coupled to the syringe body.

[0357]

[0467] 167. In the injection system,

[0468] a syringe body having a proximal end and a distal end and a syringe interior;

[0469] A stopper member disposed inside the syringe;

[0470] a plunger member coupled to the stopper member and configured to be manipulated relative to the syringe body to distally insert the stopper member into the syringe interior;

[0471] a needle coupled to a distal end of the syringe body;

[0472] and an RFID tag configured to be activated during an injection.

[0358]

[0473] 168. The system of embodiment 167, wherein the RFID tag is:

[0474] An RFID processor;

[0475] a shunt that diverts power from the RFID processor to reversibly deactivate the RFID tag.

[0359]

[0476] 169. The system of embodiment 168, wherein the plunger member includes a movable proximal end pad having a cutting member configured to sever the shunt and activate the RFID tag when pressure is applied to the plunger proximal end pad.

[0360]

[0477] 170. The RFID tag is:

[0478] An RFID processor;

[0479] The system of embodiment 167, further comprising an open circuit that reversibly deactivates the RFID tag.

[0361]

[0480] 171. The system of embodiment 170, wherein the plunger member includes a movable proximal end pad having a conductive member configured to close an open circuit and activate an RFID tag when pressure is applied to the plunger proximal end pad.

[0362]

[0481] 172. In the system of embodiment 167,

[0482] the plunger member including a proximal end pad;

[0483] The system wherein the RFID tag includes a helical antenna disposed on a proximal end pad.

[0363]

[0484] 173. The system of embodiment 167, wherein the RFID tag comprises an elongated antenna disposed on the plunger member.

[0364]

[0485] 174. Embodiment 173, wherein the RFID tag comprises a pair of elongated antennas disposed on the plunger member.

[0365]

[0486] 175. The system of embodiment 167, wherein the RFID tag is selected from the group consisting of low frequency, high frequency, and ultra-high frequency.

[0366]

[0487] 176. The system of embodiment 167, wherein the RFID tag includes a battery.

[0367]

[0488] 177. A method for collecting information about injections, the method comprising:

[0489] Providing an injection system, the system comprising:

[0490] a syringe body having a proximal end and a distal end and a syringe interior;

[0491] a stopper member disposed inside the syringe;

[0492] a plunger member connected to the stopper member and having a moveable proximal end pad;

[0493] a needle coupled to a distal end of the syringe body;

[0494] and

[0495] and manipulating a proximal end pad of the plunger member to distally insert the stopper member into the syringe relative to the syringe body to perform an injection.

[0496] The method, wherein the step of manipulating the proximal end pad of the plunger member to insert a stopper member moves the proximal end pad distally relative to the plunger member, thereby activating an RFID tag.

[0368]

[0497] 178. The method of embodiment 177, wherein the RFID tag comprises:

[0498] An RFID processor;

[0499] and a shunt that diverts power from the RFID processor to reversibly deactivate the RFID tag.

[0369]

[0500] 179. The method of embodiment 178, further comprising a cutting member configured on the movable proximal end pad;

[0501] The method wherein moving the proximal end pad distally causes a cutting member to cut the shunt, thereby activating the RFID tag.

[0370]

[0502] 180. The method of embodiment 177, wherein the RFID tag comprises:

[0503] An RFID processor;

[0504] and opening a circuit to reversibly deactivate the RFID tag.

[0371]

[0505] 181. The method of embodiment 180, wherein the movable proximal end pad includes a conductive member;

[0506] The method wherein moving the proximal end pad in a distal direction closes an open circuit, thereby activating the RFID tag.

[0372]

[0507] 182. The method of embodiment 177, wherein the RFID tag includes a helical antenna disposed on a proximal end pad.

[0373]

[0508] 183. The method of embodiment 177, wherein the RFID tag includes an elongated antenna disposed on the plunger member.

[0374]

[0509] 184. The method of embodiment 183, wherein the RFID tag includes a pair of elongated antennas disposed on the plunger member.

[0375]

[0510] 185. The method of embodiment 177, wherein the RFID tag is selected from the group consisting of low frequency, high frequency, and ultra-high frequency.

[0376]

[0511] 186. The method of embodiment 177, wherein the RFID tag includes a battery.

[0377]

[0512] 187. The method of embodiment 177, further comprising the step of the RFID tag establishing a connection with the RFID reader.

[0378]

[0513] 188. The method of embodiment 187, further comprising the step of the RFID tag transmitting injection data to an RFID reader.

[0379]

[0514] 189. The method of embodiment 188, wherein the injection data includes data selected from the group consisting of drug name, drug dosage, serial number, and expiration date.

[0380]

[0515] 190. The method of embodiment 187, further comprising the step of the RFID tag receiving data from an RFID reader.

[0381]

[0516] 191. The method of embodiment 190, further comprising the step of the RFID tag deactivating itself in response to receiving data from an RFID reader.

[0382]

[0517]

[0518] Although the various systems and methods described herein refer to injection systems having a manually actuated plunger member, the systems and methods for collecting injection data described herein function equally well with automatic or semi-automatic injection systems, such as injection pens.

[0383]

[0519] Various exemplary embodiments are described herein. These examples are referred to in a non-limiting sense. They are provided to illustrate the more broadly applicable embodiments. Various changes can be made to the described embodiments, and equivalents can be substituted without departing from the true spirit and scope of the embodiments. In addition, many modifications can be made to adapt a particular situation, material, composition of matter, process, process acts or steps to the objective, intent or scope of the present embodiments. Moreover, those skilled in the art will understand that each of the individual variations described and illustrated herein have distinct components and features that can be easily separated or combined with the features of some other embodiments without departing from the scope or intent of the present embodiments. All such modifications are intended to be within the scope of the embodiments related to this disclosure.

[0384]

[0520] Any of the devices described for performing procedures for collecting subject injection information may be provided in packaged combinations for use in performing such interventions. These supply "kits" may further include instructions for use and / or may be packaged in sterile trays or containers commonly used for such purposes.

[0385]

[0521] The above embodiments include methods that may be performed using the subject apparatus. These methods may include the act of providing such a suitable device. Such providing may be performed by an end user. In other words, the act of "providing" may simply be the act of obtaining, accessing, approaching, locating, configuring, initiating, powering on, or otherwise, of an end user providing the necessary device for a subject method. The methods recited herein may be performed in any order of the recited events that is logically possible, not just the order of the recited events.

[0386]

[0522] Exemplary embodiments are described above with details regarding material selection and manufacture. Other details of the embodiments will be understood in conjunction with the above-referenced patents and publications and are generally known or recognized by those skilled in the art. For example, those skilled in the art will understand that one or more lubricious coatings (e.g., hydrophilic polymers such as polyvinylpyrrolidone-based compositions, fluoropolymers such as tetrafluoroethylene, hydrophilic gels or silicones) can be used in conjunction with various parts of the device, such as relatively large interfaces of movably connected parts, for example, to facilitate low-friction manipulation or advancement of such objects relative to other parts of the instrument or nearby tissue structures, as needed. The same may be true with respect to method-based features of the embodiments with respect to additional actions generally or logically taken.

[0387]

[0523] Furthermore, while the above embodiments have been described with reference to several examples that optionally incorporate various features, these embodiments are not limited to those described or illustrated as contemplated for each variation of the embodiments. Various modifications can be made to the described embodiments, and equivalents (whether listed herein or not included for brevity) can be substituted without departing from the true spirit and scope of the embodiments. Furthermore, when a range of values ​​is provided, it will be understood that every intervening value between the upper and lower limits of that range and any other stated or intervening value within that range is included in the above embodiments.

[0388]

[0524] It is also to be understood that any feature of the described inventive variation may be described and claimed independently or in combination with any one or more of the features described herein. Reference to a single item includes the presence of a plurality of the same items. More specifically, the singular forms "a," "an," "said," and "the," as used herein and in the claims related thereto, include plural referents unless otherwise indicated. In other words, the use of the above terms may refer to "at least one" of the subject matter items of the claims related to the above description and this disclosure. It is further noted that such claims may be written to exclude any element. As such, this description is intended to serve as a prerequisite for the use of exclusive terms such as "only," "only," and the like in connection with the recitation of claim elements and the use of "negative" limitations.

[0389]

[0525] Without using such exclusive language, the term "comprising" in the claims associated with this disclosure allows for the addition of additional elements or features that are believed to change the nature of the elements recited in those claims, regardless of whether a specific number of elements are recited in such claims. Unless otherwise defined herein, all technical and scientific terms used herein are to be given the broadest possible commonly understood meaning while maintaining the validity of the claims.

[0390]

[0526] The breadth of the present invention is not limited to the specific examples and / or subject matter provided, but rather is limited only by the scope of the claims associated with this disclosure.

Claims

1. 1. A system for measuring an injection of a medical solution, comprising: a syringe body having a proximal end and a distal end, a syringe interior, and a syringe flange at the proximal end; A stopper member disposed inside the syringe; a plunger member coupled to the stopper member and configured to be manipulated to insert the stopper member distally into the syringe interior relative to the syringe body; a needle coupled to a distal end of the syringe body; a sensor flange removably coupled to the syringe body, the sensor flange comprising: a sensor for measuring an injection characteristic; and a processor that analyzes the injection characteristics to determine the occurrence of an injection event.

2. The system of claim 1 , wherein the injection event is an injection of a dose of a medical fluid.

3. The system of claim 2 , wherein the sensor is a force sensor and the injection characteristic is a force applied to the plunger member.

4. The system of claim 3 , wherein the processor calculates a force-time product of injection of the dose of the medical solution.

5. The system of claim 2 , wherein the sensor is an optical sensor and the injection characteristic is a position, a velocity, or an acceleration of the plunger member.

6. The system of claim 5 , wherein the optical sensor is an IR sensor.

7. The system of claim 5 , wherein the plunger member includes a visual feature that is read by the optical sensor.

8. The system of claim 2 , wherein the sensor is an acoustic sensor and the injection characteristic is a position, a velocity, or an acceleration of the plunger member.

9. The system of claim 8 , wherein the acoustic sensor is an acoustic reflective sensor configured to measure a distance from the sensor to a proximal end pad on the plunger member.

10. The system of claim 8 , wherein the acoustic sensor is an acoustic reflective sensor configured to measure a distance from the sensor to the stop member.

11. The system of claim 2 , wherein the sensor is a mechanical sensor and the injection characteristic is a position, a velocity, or an acceleration of the plunger member.

12. The mechanical sensor includes: a roller in contact with an outer surface of the plunger member; and a reader for measuring rotation of the roller.

13. The system of claim 12 , wherein the reader is an optical sensor or a mechanical sensor.

14. the mechanical sensor comprises a contact switch; the plunger member includes a mechanism for actuating the contact switch; The system of claim 11 , wherein the injection characteristic is a position of the plunger member.

15. the sensor is an optical sensor, and the system further comprises: A light source; a light guiding optical element that guides the light from the light source and the reflected light to the optical sensor; The system of claim 2 , wherein the injection characteristic is a position of a stopper member.

16. The system of claim 1 , wherein the sensor flange is removably coupled to the syringe body at least partially distal to the syringe flange.

17. the sensor is a first sensor and the injection characteristic is a first injection characteristic; The system of claim 1 , wherein the sensor flange further includes a second sensor for measuring a second injection characteristic.

18. The system of claim 1 , wherein the sensor flange is configured to be manipulated relative to the syringe body to distally insert the stopper member into the syringe interior.

19. 20. The system of claim 18, wherein the plunger member includes a proximal end pad that is manipulated simultaneously with the sensor flange to insert the stopper member distally into the syringe interior relative to the syringe body.

20. the sensor flange further comprising an attachment sensor for detecting when the sensor flange is removably coupled to the syringe body; the sensor flange is configured to generate an alarm when injection of the dose of medical solution is complete to prevent premature disposal of the sensor flange; 3. The system of claim 2, wherein the alarm is silenced when the attachment sensor indicates that a finger flange has been removed from the syringe body.

21. The system of claim 20 , wherein the attachment sensor comprises a mechanical switch.

22. The system of claim 1 , wherein the sensor flange further includes one or more of a battery, a speaker, an indicator light, a clock, a calendar, non-volatile computer memory, a tactile feedback device, and a display device.

23. 5. The system of claim 4, wherein the sensor flange is configured to compare a measured force-time product with a reference force-time product to identify the occurrence of the injection event.

24. 24. The system of claim 23, wherein the sensor flange is configured to record a date and time of occurrence of the injection event.

25. 24. The system of claim 23, wherein the reference force-time product is predetermined based on a viscosity of a medical solution to be injected and a size of the needle.

26. The system of claim 1 , wherein the sensor flange further comprises a display for communicating information to a user administering an injection.

27. 27. The system of claim 26, wherein the display alerts the user if the injection is too fast or too slow.

28. The system of claim 1 , wherein the sensor flange further comprises a speaker that generates an audible sound for communicating with a user administering the injection.

29. 30. The system of claim 28, wherein the speaker alerts the user if an injection is performed too quickly or too slowly.

30. 10. The system of claim 1, wherein the sensor flange further comprises one or more output devices for delivering a calendar, a clock, and an audible, visual, and / or tactile alarm to indicate when it is time for an injection.

31. The system of claim 1 , wherein the sensor flange is configured with a computer network communication protocol for communicating that the injection event has occurred.

32. 32. The system of claim 31, wherein the sensor flanges communicate intermittently / asynchronously or constantly.

33. 10. The system of claim 1, wherein the sensor flange further comprises a calendar and clock, the sensor flange storing a date and time of the occurrence of an injection event as injection event data in non-volatile memory.

34. 34. The system of claim 33, wherein the injection event data further comprises F x t product, injection execution indicator, temperature, rate, pressure, and spray into air / inject into patient indicator.

35. 34. The system of claim 33, wherein stored injection event data is transmitted when network communication is established between the sensor flange and a computer network.

36. 32. The system of claim 31, wherein the sensor flange transmits the injection event data to one or more of a smartphone, a computer, a database, a cloud computing network, a medical professional, a home injection patient, an electronic medical record, a smartphone application, a doctor, a nurse, a caregiver, a health insurance company, a clinical trial, a clinical trial administrator, a pharmaceutical distribution company, and a pharmaceutical manufacturer.

37. The system of claim 1 , wherein the sensor flange further comprises an output device that generates an alarm when turbulence is detected in the system.

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