Injection information collection system

Abstract

To provide a system for measuring injection of a liquid medicine.SOLUTION: A system includes a syringe body 112 having a proximal end 120 and a distal end 122, a syringe interior 124, and a syringe flange 126 at the proximal end 120 thereof. The system also includes a stopper member 114 disposed in the syringe interior 124. The system further includes a plunger member 116 coupled to the stopper member 114 and configured to be manipulated to insert the stopper member 114 distally in the syringe interior 124 relative to the syringe body 112. Moreover, the system includes a needle 130 coupled to the syringe body at the distal end 122 thereof. In addition, the system includes a sensor flange 150 removably coupled to the syringe body 112. The sensor flange 150 includes a sensor 152 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] This application relates generally to injection systems, devices, and processes for achieving various levels of control over fluid injection, and more particularly to systems and methods related 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] Millions of syringes (2), such as those shown in FIG. 1A, are consumed daily in medical settings. A typical syringe (2) includes a tubular body (4), a plunger (6), and a needle (8). As shown in FIG. 1B, such syringes (2) can be used 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 syringes (2) are used with vials (10), as illustrated in certain patient settings, the vials must be used with a single patient and then discarded, resulting in significant medical waste of the bottles and discarded remaining medication, and contributing to periodic shortages of certain critical medications.

[0003] Referring to FIG. 2A, three luer-type syringes (12) are shown, each with a distal 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 FIG. 2B. The luer manifold assembly of FIG. 2B can be used to administer medicinal fluids intravenously to a patient, with or without an intravenous fluid bag. The luer fittings (14) on the syringes in FIG. 2A are referred to as "male" luer fittings, while the luer fittings in FIG. 2B (18) are referred to as "female" luer fittings. One of the luer 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, which 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 the male fitting (14) that are configured to engage a flange on the female fitting (18), together providing 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 a configuration may be referred to as a "slip-on" or "conical" luer configuration). 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 the risk of a sharp needle contacting or pricking 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 into 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 upon itself may be associated with issues of blood splatter / 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 compression volume of the spring, and / or loss of retraction speed control that may cause 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. Syringe assemblies generally include 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 can be attached to a luer-type interface (Figure 5A shows the cap 35 in place, while Figure 5B shows the cap removed to reveal 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 lubricious coating (e.g., polytetrafluoroethylene ("PTFE")) to provide favorable sealing and relative motion characteristics relative to the associated syringe body (34) structure and material. The proximal end of the syringe body (34) in FIG. 5B has a conventional, one-piece syringe flange (38) integrally formed with the material of the syringe body (34). This flange (38) is configured to extend radially from the syringe body (34) and may be configured to extend fully or partially around the syringe body (34). A partial flange is referred to as a "clip flange," while a full flange is referred to as a "full flange." The flange is used to provide support for gripping the syringe with the fingers and for depressing the plunger to inject. The syringe body (34) is preferably made of a translucent material, such as glass or a polymer. A plunger tip (36) can be positioned within the syringe body (34) to form a containment volume within a chamber or reservoir (40) and assist in the ejection of associated fluid through the needle. Syringe body (34) can be configured to define a substantially cylindrical shape (so that a plunger tip 36 having a circular cross-sectional shape can establish a seal with the syringe body) or to have other cross-sectional shapes, such as an oval.

[0006] Such assemblies are desirable because they are standardized and produced in precise volumes by a small number of manufacturers worldwide, allowing them 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 typically do not meet emerging global standards for disposability, safety, self-disabling, and needlestick protection. Therefore, certain suppliers are moving toward more "vertical" solutions, such as the system (41) shown in FIG. 5C, that attempt to meet all or at least some of the standards in a single 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 noncompliance 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 injectable medication delivery, thereby reducing healthcare costs and improving healthcare outcomes (e.g., by determining whether the injection was properly delivered). By automating the collection of injection information, these and many other advantages can be achieved 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 injectable medication delivery. Collected injection information can also be transmitted to third parties (e.g., healthcare providers, insurance companies) to improve healthcare management and personalization.

[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) 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 safety injection systems that transition 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. 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. The system further 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 first and second sensors 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 the user fills prior to administering the 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 sensor flange's electronics and sensor can be located in or on the plunger rod.

[0013] In one or more embodiments, the first sensor is a force sensor, the first injection characteristic is injection back pressure, and the second sensor is a motion sensor, and the second injection characteristic is plunger member movement. The injection event may be a jet to atmosphere. The sensor flange may include an orientation sensor that measures orientation, and the processor analyzes the orientation to confirm the jet 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] 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 the position, velocity, or 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 read by the optical sensor. The identifier may include data selected from the group consisting of a medication name, a medication 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 within the syringe. The processor may calculate an approximate time for the injectable substance to reach the injection temperature based at least in part on the measured temperature. The sensor flange may also include an output device that sends an alarm signal when the measured temperature reaches the injection temperature.

[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. This post-injection data may include data selected from the group consisting of injection date and time, injection frequency, plunger force, elapsed injection 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 for collecting information about 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] 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 using a first sensor to measure the first injection characteristic and a second sensor to measure the second injection characteristic. The first sensor may be a force sensor, and the first injection characteristic may be injection backpressure. The second sensor may be a motion sensor, and the second injection characteristic may be movement of the plunger member. The injection event may be a spray to atmosphere, and the method also includes detecting the spray 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 can be a needle occlusion, and the method can also include detecting the needle occlusion when the injection backpressure increases while the plunger member is moving substantially zero. The injection event can be a leak from the injection system, and the method can also include detecting the leak from the injection system when the injection backpressure decreases while the plunger member is moving increasingly.

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

[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 the 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] 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 steps of the wireless communication device establishing a connection with a 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 can include data selected from the group consisting of injection date and time, injection frequency, plunger force, elapsed injection time, injection error-related data, viscosity, temperature, warming time, shear force, medication remaining in the syringe, multiple injection site regimen data, reward program data, and education / marketing data. The injection error can be selected from the group consisting of medication identification error, injection timing error, dosage error, shear force error, degassing error, residual medication remaining in the syringe, and multiple site injection error.

[0032] In one or more embodiments, the method also includes the steps of 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 steps of the sensor flange detecting the injection, the clock measuring a predetermined time after the detected injection, and the processor instructing 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, by 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. The method may include the step of, by 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 processor instructing an output device to issue a velocity alert when the velocity of the plunger member is outside a predetermined range. The velocity alert may indicate that the velocity of the plunger member is 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 multi-site administration message. The first injection characteristic can include a sound indicating the completion of the injection.

[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 equals 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 instructing 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 can 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 the longitudinal axis of the syringe body until the sensor flange contacts the 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 operated to distally insert the stopper member into the syringe interior relative to the syringe body. The system further includes a needle coupled to the distal end of the syringe body. The system further includes an RFID tag configured to be activated during injection.

[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 movable 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 ultra-high frequency. The RFID tag may include a battery.

[0047] In yet another embodiment, a method for collecting information about 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 movable proximal end pad. The system further includes a needle coupled at its distal end to the syringe body. The system further 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 movable 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 ultra-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 an 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 a medication name, a medication dosage, a serial number, and an 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] 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 sensor or a 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] 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 the light-directing optical element directing light from the light source and reflected light toward 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 can 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] 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 issuing an alarm when injection of the dose of the medicinal fluid is completed to prevent premature disposal of the sensor flange. 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 detached 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, non-volatile computer memory, a tactile feedback device, and a display device.

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

[0059] In one or more embodiments, the sensor flange also includes a display, and the method further includes the step of the display communicating information to a user administering the injection. The method may also include the step of 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 step of the speaker generating an audible sound to communicate with the user administering the injection. The method may also include the step of 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 alarm, a visual alarm, and / or a tactile alarm. The method may also include the step of the sensor flange indicating that it is time to inject.

[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] In one or more embodiments, the sensor flange also includes a calendar and a clock, wherein the sensor flange stores the date and time of the injection event occurrence as injection event data in the non-volatile memory. The injection event data may include an F×t product, an injection execution indicator, temperature, speed, pressure, and an indicator of airborne / patient injection. The method may also include transmitting the stored injection event data upon establishment of network communication between the sensor flange and a computer network. The method may also 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 within the injection system.

[0062]

[0062] The above and other embodiments are described in the detailed description that follows. [Brief explanation 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. [Figure 2] 2A-2B show various features of a conventional syringe configuration. [Figure 3] FIG. 3 illustrates various features of a conventional syringe configuration. [Figure 4] 4A-4B illustrate various features of a conventional syringe configuration. [Figure 5] 5A-5C illustrate 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, Figures 10B-10E show the sensor flange removably coupled to the injection system, and Figure 10F shows the sensor flange, according to one embodiment. [Figure 11] 11A-11B illustrate methods for 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 methods 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 in 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. [Figure 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 in an injection system according to one embodiment in a deactivated and activated state. [Figure 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 for transmitting injection information using an RFID chip, according to one embodiment. [Figure 30] FIG. 30 shows a sensor flange according to another embodiment. [Figure 31] FIG. 31 is a graph showing injection force versus time, according to one embodiment. [Figure 32] FIG. 32 illustrates a method for determining completion of injection of a predetermined dose using an injection system, according to one embodiment. [Figure 33] FIG. 33 is a graph showing injection force x t versus thumb force according to various embodiments. [Figure 34] FIG. 34 shows a sensor flange according to yet another embodiment. [Figure 35] FIG. 35 shows a sensor flange (FIG. 35) removably coupled to an injection system (FIG. 36) according to yet another embodiment. [Figure 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. [Figure 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. [Figure 41] FIG. 41 shows a sensor flange (FIG. 41) removably coupled to an injection system (FIGS. 42 and 43) according to yet another embodiment. [Figure 42] FIG. 42 shows a sensor flange (FIG. 41) removably coupled to an injection system (FIGS. 42 and 43) according to yet another embodiment. [Figure 43] FIG. 43 shows a sensor flange (FIG. 41) removably coupled to an injection system (FIGS. 42 and 43) according to yet another embodiment. [Figure 44] FIG. 44 illustrates a method for collecting injection information according to various embodiments. [Figure 45] FIG. 45 shows a sensor proximal end pad removably coupled to an injection system, according to one embodiment.

[0064]

[0091] 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 limiting of the scope of the embodiments. DETAILED DESCRIPTION OF THE INVENTION

[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) and 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 operation of the plunger member (116) using one finger of the user's hand (e.g., the thumb) while one or more other fingers of the user's hand provide a counter force (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 measured by the force sensor 152 is approximately the same as that applied by the user's thumb; and the relatively large size of the target (i.e., the syringe body 112) makes it 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 inward within the syringe interior (124). In some embodiments, the force measured by the force flange sensor (152) can be recorded to generate a force profile that can be analyzed to determine the occurrence and timing of specific injection events. For example, if the force measured in the force profile suddenly increases, a processor (not shown) in the sensor flange (150) can determine that the stopper member (114) has reached the distal end (122) of the syringe body (112) and that the injection is complete. Although the flange force sensor (152) is described as a partially mechanical device, various other sensors (e.g., resistance-based) can also function as a flange force sensor. Additionally, the time from the start of sustained depression to the end of injection (e.g., as measured by a clock) can be combined with 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 via 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 lit lights in the array. Similarly, a 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 via binary (i.e., beep) sounds, tones, spoken text signals / messages (e.g., using pre-recorded and / or computer-generated voice), etc. Although these output devices (154, 156) are described as displays and / or speakers, various other output devices (e.g., 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 counterforce against thumb pressure). The output devices (154, 156) of the sensor flange (150) can provide useful reminders to the user 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" with 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 may 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 actuation). The attachment sensor 158 also has a “bound” state in which the attachment sensor 158 is depressed due to interaction with the outer 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 indicate 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, various 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 measured motion is the movement 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 through (i.e., is read by) 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 a predetermined optical marker on the plunger member 116 such that the predetermined optical marker passes through the motion sensor 160 at the end of the injection, the motion sensor 160 can 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 (velocity) over time and / or the change in velocity (acceleration) over time 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 captures a series of still photographs / images of the plunger member 116 as it moves. The series of still images is transmitted to an image processor (not shown) within the sensor flange 150. The image processor analyzes the series of still images to detect patterns therein and calculates the pixel shift from one image to the next. Pixels can be identified, particularly at edges or other points of interest in the images. This pixel shift can be used to calculate the distance traveled by that pixel (and thus the plunger member 116) from one image to the next. This pixel shift and a predetermined time between image frames can 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, or texture. In some embodiments, the distances traveled by the plunger member (116) are summed, and 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), the sensor flange (150) determines that the full dose has been delivered.

[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), multiple lenses (168) that focus the light reflected 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 measurement of the change in position (velocity) and / or the change in velocity (acceleration) over time of the plunger member (116) relative to the sensor flange (150).

[0074]

[0101] In other embodiments, the motion sensor (160) may be a rangefinder (e.g., acoustic, infrared, laser, etc.) that measures the distance between the sensor flange (150) and the user's thumb. One advantage of using a rangefinder 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 rangefinder motion sensor (160). FIG. 9 shows an exemplary acoustic rangefinder including a narrowband ultrasonic transducer. The rangefinder motion sensor (160) shown in FIG. 9 includes a narrowband ultrasonic transducer, a transmitter, an amplifier, and a decision circuit. In some embodiments, the acoustic rangefinder can also emit a sound that can be detected by an acoustic sensor (described below). Because the acoustic rangefinder can produce 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 a completed injection. 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 various 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, sensor flange 150 includes an opening 162 configured to allow sensor flange 150 to be snap-fit ​​onto proximal end 120 of syringe body 112 relative to syringe flange 126. Sensor flange 150 may be retained in syringe body 112 by an interference fit.

[0077]

[0104] 6 and 7, the sensor flange (150) may include a power source for driving the various sensors (152, 158, 160) and output devices (154, 156). The power source may 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 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 communications 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 communications link may include a Bluetooth link, a WiFi link, a WiFi Direct link, a near-field communication link, a cellular network link, or the like. The communications link facilitates the exchange of data, including injection setup data and post-injection data. Injection setup data includes, but is not limited to, the current date and time, the date and time of the first injection, the injection frequency, the syringe type, the viscosity, the temperature, the warming time, the maximum shear force, the multiple injection site regimen data, the rewards program data, and educational / marketing data. Post-injection data includes, but is not limited to, the injection date and time, the measured injection parameters described above, and data related to injection errors. 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. Post-injection data can be used to track patient compliance, drive reward programs, notify insurance programs, etc. Sufficient memory can be provided to store days or weeks of post-injection data. Storing post-injection data in memory ensures that 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 post-injection data even under unfavorable conditions (e.g., compliance).

[0079]

[0106] Although not shown in FIGS. 6 and 7, the sensor flange (150) may further include a memory module for storing data. Stored data includes, but is not limited to, the injection setup data and post-injection data described above. Storing the injection setup data allows 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 allows the sensor flange (150) to download / transmit (e.g., wirelessly) the injection data to a healthcare professional in a batch operation at a convenient time. For example, post-injection data may be downloaded in batches when a patient picks up their medication at a pharmacy. Post-injection data can be used to monitor patient compliance and improve patient care. Post-injection data can also be used to calculate compliance courses, facilitate compliance reward programs, modify insurance premiums, and the like.

[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 a temperature sensor 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) equipped with a temperature sensor may be configured to alert the user (e.g., via an output device) when the temperature of the syringe body (112) and the injectable substance contained therein reaches a range appropriate for injection. Such a system may store the measured temperature during injection. Furthermore, such a system may use the measured temperature to calculate the approximate time until the syringe body (112) and the injectable substance contained therein reaches a range appropriate for injection. Furthermore, the temperature measurement of the drug may be used to calculate the viscosity of the drug for use in calculating injection pressure or flow rate.

[0081]

[0108] Alternatively, the user can be instructed to wait a predetermined period of time after clipping on the sensor flange 150 to allow the refrigerated medication to warm prior to injection. An output device (e.g., speaker 156) can then indicate when this approximate warming time has expired. This method of indicating the expiration of the warming time does not require a temperature sensor. The injection input and injection time can be used to verify the viscosity of the medication and adjust the warming 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 be programmed to instruct an output device to deliver an alarm signal to the user when it is time for injection. The output device may be instructed to emit an alarm signal for a predetermined period of time (e.g., one hour), then silence for a predetermined period of time (e.g., one hour), repeating 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's injection is late, the processor may instruct the output device to provide the user with advice regarding the delayed 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 illustrate 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-filled 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 rate. The marker (136) can be a line, barcode, text, a 2D barcode, or other pattern that can be read by an electronic device in the sensor flange to record drug information and / or plunger member movement. The marker (136) can also be provided on the syringe body (112), syringe flange (126), or elsewhere in the injection system so that the sensor flange (150 in FIG. 10B) can read the marker during or after installation. Alternatively, injection information can be preprogrammed into the sensor flange during manufacture or downloaded to the flange at a later time. The injection system (110) further includes a luer cap (134) that fluid-tightly 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, in which 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 snap onto the proximal end 120 of the syringe body 112 relative to the syringe flange 126. Unlike the sensor flange 150 shown in FIGS. 6 and 7, which snap 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 shown in FIG. 10B is configured so that the syringe flange 126 is positioned 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 also 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 on 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 positioning the predetermined optical marker 136 on the plunger member 116 so 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 Figure 1OC, 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, causing the plunger member 116 and its attached stopper member 114 to move 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 substance into the tissue punctured by the needle. In Figure 10D, the predetermined optical marker (136) on the plunger member (116) is in a position before it enters the sensor flange (150) and before the reading, which corresponds to the position of the stopper member (114) near (but not yet at) the end of the injection.

[0088]

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

[0089]

[0116] After the injection is completed, the needle 130 may or may not be retracted into the syringe interior 124 and / or plunger member 116. Additionally, after the injection is completed, the sensor flange 150 can be removed 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 can be safely disposed of after removing the sensor flange 150. The reusability of the sensor flange 150 can 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) shown in FIGS. 10A-10E. The sensor flange (150) includes a pair of output devices (154, 156), an opening (162), and an optical sensor (160) positioned adjacent to 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 via binary (i.e., on / off) signals, color signals, icons, descriptive text signals / messages, 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 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). While the output devices (154, 156) are described as displays and / or speakers, in other embodiments, various other output devices (e.g., tactile, 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. In 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 to or identical to the 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 the plunger member of the injection system, for example, using a finger (e.g., thumb) of the user's hand to apply a force to 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 the 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] In 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 in 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 to 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 the plunger member of the injection system, for example, using a finger (e.g., thumb) of the user's hand to apply a force to 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 the syringe flange or a sensor flange disposed thereon).

[0099]

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

[0100]

[0127] In step (222), the sensor flange measures second, third, fourth, etc. injection characteristics using 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 different types of sensors. The type of sensor may be selected to measure the type of injection characteristic required for 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. In 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 to 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 the plunger member of the injection system, for example, using a finger (e.g., thumb) of the user's hand to apply a force to 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 the 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 (distal, proximal, interior, etc.) of the sensor flange. 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), as described above, the sensor flange measures the movement of the plunger using a motion sensor. For example, the motion sensor may be an optical sensor, an IR sensor, an acoustic sensor, an ultrasonic distance meter, or the like. 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 the sensor flange's memory.

[0106]

[0133] At step 320, the sensor flange (i.e., the processor therein) analyzes the injection backpressure and plunger movement 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 moves distally. The sensor flange may use fluid equations (e.g., fluid flow through an orifice, Bernoulli's equation, Hagen-Poiseuille equation, or other methodologies) 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)). Injection system parameters include, but are not limited to, the needle inner diameter, needle length, needle tip geometry, syringe body diameter, force applied to the sensor flange or plunger member proximal end pad, speed of plunger member movement, dynamic and static friction forces between the stopper member and syringe body, temperature and / or viscosity of the injectable substance (e.g., drug), density of the injectable substance (e.g., drug), and / or other metrics for performing calculations. Injection backpressure can be calculated by measuring the force applied to 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 of ​​the syringe interior. If the calculated pressure drop indicates that the pressure at the needle tip is approximately 1 atmosphere, the sensor flange determines a jet to atmosphere. If the calculated pressure at the needle tip exceeds 1 atmosphere, the sensor flange determines an injection to the patient. A jet to atmosphere event may or may not be an injection error, depending on its duration and the orientation of the injection system during the jet to atmosphere 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 ejecting it into the atmosphere, which will push the air bubbles that have migrated to the distal / top end of the syringe out of the needle.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 to it. In optional step (324), the processor and syringe flange analyze the orientation to determine the type of spray-to-air event. If the syringe body is oriented generally upward and the duration of the spray-to-air event is relatively short, the processor identifies the spray-to-air event as a degassing operation. If the syringe body is not oriented generally upward and the spray-to-air event continues substantially throughout the injection, the processor identifies the spray-to-air event as an error. In either case, the orientation of the syringe body can be stored in the sensor flange's memory. The sensor flange may transmit an alarm signal (e.g., visual or audible) to alert the 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 to 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 the plunger member of the injection system, for example, using a finger (e.g., thumb) of the user's hand to apply a force to 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 the syringe flange or a sensor flange disposed thereon).

[0110]

[0137] In 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 to perform an injection, the force sensor on the sensor flange measures the proximal force on a surface (distal, proximal, interior, etc.) of the sensor flange. 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), as described above, the sensor flange measures the movement of the plunger using a motion sensor. For example, the motion sensor may be an optical sensor, an IR sensor, an acoustic sensor, an ultrasonic distance meter, or the like. The amount of motion (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 the sensor flange's memory.

[0112]

[0139] In step 420, the sensor flange (i.e., the processor therein) analyzes the injection backpressure and plunger movement 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 plunger member movement is substantially stopped. A 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 stopper member are at the distal end inside the syringe at the end of the injection, the plunger member movement 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 a needle occlusion event occurs before the plunger member reaches its 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 sensor flange's memory. 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. In 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 to or identical to the 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 the plunger member of the injection system, for example, using a finger (e.g., thumb) of the user's hand to apply a force to 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 the syringe flange or a sensor flange disposed thereon).

[0115]

[0142] In 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 on the sensor flange measures the proximal force on a surface (distal, proximal, interior, etc.) of the sensor flange. 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] In step (518), as described above, the sensor flange measures the movement of the plunger using a motion sensor. For example, the motion sensor may be an optical sensor, an IR sensor, an acoustic sensor, an ultrasonic distance meter, or the like. 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 the sensor flange's memory.

[0117]

[0144] In step (520), the sensor flange (i.e., the processor therein) analyzes the injection leak pressure and plunger movement 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 sensor flange's memory. The sensor flange may also transmit an alarm signal (e.g., visual or audible) to alert the user upon detecting a system leak event.

[0118]

[0145] 14B illustrates a method 500' for collecting injection information according to another embodiment. In 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 to 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 the plunger member of the injection system, for example, using a finger (e.g., thumb) of the user's hand to apply a force to 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 the syringe flange or a sensor flange disposed thereon).

[0120]

[0147] In step 522, the sensor flange measures the force / 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 on the sensor flange measures the proximal force on a surface (distal, proximal, interior, etc.) of the sensor flange. 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. The difference in method 500' shown in FIG. 14B is that the force / injection backpressure is measured over time (e.g., continuously). The difference in method 500' shown in FIG. 14B is that the force / injection backpressure is measured over time (e.g., continuously).

[0121]

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

[0122]

[0149] In 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. Therefore, errors can be detected. For example, a squirt into air will have a force profile characteristic that is distinctly different from an injection into tissue.

[0123]

[0150] Figure 15 shows a method 600 for collecting injection information according to an embodiment similar to that shown in Figure 11A. In 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 to 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 the plunger member of the injection system, for example, using a finger (e.g., thumb) of the user's hand to apply force to 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 the syringe flange or a sensor flange disposed thereon).

[0125]

[0152] In step (616), the sensor flange measures a first injection characteristic using a first sensor. Similarly, in 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-mounted ("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 can be selected to measure the type of injection characteristic required for this method (600).

[0126]

[0153] In 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., injection completion, plunger force, shear force, ejection error, etc.). The type of injection event monitored in this manner (600) determines the type of injection characteristic measured by the type of sensor in the sensor flange.

[0127]

[0154] In optional step (622), the sensor flange stores post-injection data in its memory. The post-injection data may include, but is not limited to, measured first and second injection characteristics, data related to monitored injection events, injection date and time, injection frequency, plunger force, elapsed injection time, injection error-related data, viscosity, temperature, warming time, shear force, residual drug remaining in the syringe, multiple injection site regimen data, reward program data, and education / marketing data. Injection errors may 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 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 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. In 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 to 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 to 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 the syringe flange or a sensor flange disposed thereon).

[0131]

[0158] In step 716, the sensor flange detects that it remains coupled to the syringe body for a predetermined time after the injection is performed. In some embodiments, this predetermined time is one minute, two minutes, or three minutes. The sensor flange can detect that it is coupled to the syringe body using a mounted 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 in which the user forgot to detach the sensor flange from the syringe body. This, in turn, creates the possibility that the sensor flange may be discarded along with the used syringe body. Unintentional disposal of the syringe flange can result in the loss of post-injection data and valuable equipment.

[0132]

[0159] In 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 prompting 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, removing the sensor flange from the syringe body 34 causes a mechanical switch to move to a spring-biased "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 the sensor flange's memory.

[0134]

[0161] 17 illustrates a method 800 for collecting injection information according to yet another embodiment. In 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 to or identical to the injection system 110 described above. The sensor flange may be secured to the syringe body using an interference fit.

[0135]

[0162] In 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 temperature suitable 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 about the temperature suitable 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 temperature suitable 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 temperature suitable 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 a computing device via a communications connection prior to injection. The communications connection may be wired and / or wireless, as described above. The injection configuration data may include, 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 may 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 includes a clock, and the processor within the sensor flange may be programmed to command an output device within 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 (e.g., a beep), a tone with varying pitch, a computer-generated voice, a previously recorded voice, etc. A visual alarm may be a light that changes binary (light on / off), a color, a texture, an icon, etc. The processor within 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 of 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 within 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 a predetermined period of time has elapsed while the sensor flange is unattached. 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 is 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 material inside the syringe. For example, the shear force can be calculated from the injection backpressure and the movement of the plunger member. In such embodiments, if the calculated shear force exceeds a maximum shear force (which can be downloaded as injection setup data), the processor of the syringe flange instructs the 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 plunger member speed 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 multi-site administration message when a complete injection is detected as described above. The multi-site administration message includes instructions to move to the next site and an indication that the multi-site administration regimen is complete. Instructions may also be given for single-site administration.

[0145]

[0172] In some embodiments, the sensor flange may be used in combination with a dual chamber mixing and injection system to monitor the position, velocity, or acceleration of the plunger rod and provide an alarm if the mixing and / or injection is too fast or too slow, thereby instructing the user on proper injection technique.

[0146]

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

[0147]

[0174] Although the clock on the sensor flange (150) has been described as providing a measurement of the change in position (velocity) and / or change in velocity (acceleration) over time of the plunger rod (116) relative to the sensor flange (150), in other embodiments the clock may also measure changes in other injection characteristics over time. For example, the clock may be used to measure / calculate 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 to the opening 1162.

[0149]

[0176] The sensor flange 1150 is designed to attach to the syringe body 112 (see FIGS. 6-7 and their accompanying descriptions) in a manner similar to the sensor flange 150 of FIGS. 6-7. The sensor flange 1150 clips onto the syringe body 112 but is designed 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). Once the load point 1180 contacts the syringe flange 126, movement of the syringe flange 126 relative to the sensor flange 1150, which is held stationary by a user's finger, transfers a force applied to the proximal end pad 132 to the load point 1180. Load point 1180 is mechanically coupled to force sensor 1152 by lever 1182, which pivots about pivot point 1184. Load point 1180 is located approximately one-third 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 and reducing the force applied to force sensor 1152 (e.g., by approximately one-third). This configuration allows the use of off-the-shelf force sensors 1152 that do not have the appropriate sensitivity for this sensor flange 1150 by attenuating the force transmitted to force sensor 1152. The sensor flange (1150) shown in FIG. 30 includes a lever (1182) that dampens the force transmitted to the force sensor (1152), but other sensor flanges (not shown) may have the force sensor directly below 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 / 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 / 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 then converted into a numerical data point. 4 where ΔP is the pressure difference between the two ends of 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. ΔP = force ("F") on the syringe cross-sectional area ("A"), and Q = dose ("D") over time ("t"), so the formula is ΔP = ΔDμL / 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 injecting the same dose using the same injection system, F x t is constant (i.e., = k). Therefore, F1 x t1 = F2 x t2, 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 can be configured to calculate F×t over 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 using 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 before 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 cumulative F×t. If the difference is less than zero (i.e., the cumulative 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), 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 healthcare 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, a clinical trial administrator, a drug 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 the 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). To facilitate this determination, a table of common needle sizes may be stored in the processor. 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 complete dose delivery, which is more accurate with a needle that does not have turbulence. Therefore, the sensor flange 1150 can be configured to detect / calculate injection characteristics indicative of turbulence. FIG. 33 shows a graph 1400 of the total 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 indicates 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. Therefore, the processor can use the instantaneous F×t calculated (e.g., as shown in method 1300) to determine when the thumb force becomes large enough to cause turbulence. 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 via 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) can communicate via binary (i.e., beep) tones, tonal tones, spoken text signals / messages (e.g., using pre-recorded and / or computer-generated voice), etc. While the output devices (1155, 1156) are described as a display and / or speaker, various other output devices (e.g., tactile, etc.) can 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 mounting sensor 1158 may be a partially mechanical device (e.g., a switch) that has two states. The mounting sensor 1158 has an “unbound” state in which the mounting sensor 1158 is not depressed and protrudes from the surface of the sensor flange 1150 due to a biasing force (e.g., spring actuation). The mounting sensor 1158 also has a “bound” state in which the mounting sensor 1158 is depressed due to interaction with the outer surface of the syringe body 112 located in the opening 1162. The depressed mounting sensor 1158 sends a message to a processor (not shown) within the sensor flange 1150 to indicate 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 dose delivery completion 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 distance traveled by the plunger member (116) is 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] Figure 34 shows an injection system (1510) according to another embodiment that also determines dose delivery completion using the distance traveled by the stopper member (114) and the plunger member (116) coupled thereto. The injection system (1510) includes a sensor flange (1550) having an acoustic echo sensor (1588) such as the one (160) shown in Figure 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 necessary to determine dose delivery is the distance from the stopper member 114 to the distal end 122 of the syringe body 112. Alternatively, the ultrasonic echo sensor 1588 may be aimed at the syringe body 112 to determine the distance to the stopper member 116. Alternatively, the function of the ultrasonic echo sensor 1588 may be performed by a laser rangefinder, 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 slot 1590 configured to fixedly receive syringe flange 126 of syringe body 112 to secure ultrasonic echo sensor 1588 relative to syringe body 112. Sensor flange 1550 also includes display 1555 and speaker 1556, which function as the output devices described above.

[0160]

[0187] 35 and 36 show yet another embodiment of an injection system (1610) that also uses the distance traveled by a stopper member (114) and a plunger member (116) coupled thereto to determine dose 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 the sensor flange 1650 is attached to the syringe body 112 with the syringe flange 126 in the slot 1690, the roller sensor 1692 contacts the plunger member 116. This causes a wheel within the roller sensor 1692 to rotate as the plunger member 116 moves. An optical reader or mechanical sensor in the roller sensor 1692 measures the rotation of the wheel within, and a processor within or coupled to the sensor flange 1650 determines the distance traveled by the plunger member 116 from the measured wheel rotation. While the roller sensor 1692 shown in FIG. 36 is configured for use with a 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 illustrate yet another embodiment of an injection system (1710) that also uses the travel distance of a stopper member (114) and a coupled plunger member (116) to determine dose completion. The injection system (1710) includes a sensor flange (1750) having an optical sensor (1798) and a light-guiding optical element ("light pipe") (1794) configured to determine when the stopper member (114) intersects with a light beam emitted from the optical 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 a sloped 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 from the syringe body 112 and the liquid contained therein is detected by the light 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 sloped reflective surface 1796. The dark color of the stopper member 114 reduces the reflected light reaching the light 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 inclined reflective surface (1796). As a result, 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 yet another embodiment of an injection system (1810) that also determines dose completion using the distance traveled by the stopper member (114) and associated plunger member (116). The injection system (1810) includes a sensor flange (1850) having an optical sensor (1898) configured to read / detect the marker (136), similar to the sensors (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 within the optical path of the optical sensor (1898), allowing the optical sensor (1898) to read the marker (136). Reading the marker (136) may include detecting a difference in reflected light (e.g., see FIGS. 37-40 above) and / or optical character recognition. The marker (136) may be printed or molded into the plunger member (116) and may include injection information, such as an identifier for the injection system (1810), to enable tracking of medication 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 for 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 to 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 the plunger member of the injection system, for example, using a finger (e.g., thumb) of the user's hand to apply a force to 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 the 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 of any known type, 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] In step 1918, the sensor flange measures the time of 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 started and / or 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] In step 1922, the sensor flange stores post-injection data in its memory. The post-injection data includes, but is not limited to, measured injection characteristics and injection time, data related to monitored injection events, 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, reward 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 injection site errors.

[0173]

[0200] In step 1924, the sensor flange transmits the post-injection data to a computing device. The sensor flange may 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 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, and 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, etc.

[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 injection events, 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 removably 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 the 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 using 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 described above for the sensor flange, including, but not limited to, a display, a speaker, attachment sensors, etc. The sensor thumb pad (2074) may include alternative and / or additional sensors, such as an acoustic sensor, a motion sensor, a proximity sensor, a temperature sensor, a damping force sensor, an acceleration sensor, an orientation sensor, an optical sensor, an acoustic echo sensor, a light sensor, etc.

[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 coupled to a plunger member 916 that can be manipulated to distally insert the stopper member 914 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 the 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 (e.g., a thumb) of a user's hand, while one or more other fingers of the user's hand provide a counteracting force (e.g., against the distal side of the syringe flange 926 or the body thereon).

[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; 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) was completed. Alternatively, the RFID chip (938) may communicate bidirectionally with a computing device. During injection, the computing device scans for the presence of an activated RFID chip to identify the 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) located 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 systems 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 force is applied to the proximal end (932) to move the plunger member (916) distally. 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 described above.

[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, in which 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, in which the cutting member (944) cuts the shunt (942), thereby activating the RFID chip (938). Figure 24 shows the activated RFID chip (938) with the shunt (942) cut.

[0182]

[0209] Figure 25 shows an RFID chip (938) and corresponding helical antenna (940). This RFID chip (938) and helical antenna (940) combination is configured to be placed on the proximal end (932) of the plunger member (916) for use in 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 the circuit.

[0183]

[0210] Figure 26 shows the inside of the proximal end cap (932) of the plunger member (916) used with the RFID chip (938) and helical antenna (940) combination shown in Figure 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) distally. Bridging the gap (946) provides power to the chip, activating the RFID chip (938). 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 Figure 26 is movable along the longitudinal axis of the plunger member (916), as shown in Figures 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. In step 1012, an injection system, such as that shown in Figures 18A-28B, is provided. The injection system includes an RFID chip in an deactivated state.

[0186]

[0213] At step 1014, the plunger member of the injection system is manipulated to perform the injection, for example, using a finger (e.g., thumb) of the user's hand to apply force to 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 the syringe flange or a sensor flange disposed thereon).

[0187]

[0214] In 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 embodiments shown in Figures 18A-24, the RFID tag is activated by cutting the shunt. In the embodiments 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] In step 1020, the activated RFID tag communicates with the RFID receiver to communicate post-injection information to the RFID receiver and to a computing device operably 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, notify 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 the distal end of the syringe body;

[0223] 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 the 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:

[0237] a roller in contact with the 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 includes a contact switch;

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

[0243] The system wherein 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 and

[0246] a light-guiding optical element that guides light from the light source and reflected light to the 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 operated 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 emit an alarm upon completion of injection of a dose of medical fluid to prevent premature disposal of the sensor flange;

[0255] A system in which an alarm is silenced when an attached 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 with 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 comprises 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 comprises 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 the 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 an F×t product, an injection execution indicator, a temperature, a speed, a pressure, and a spray into air / injection into patient indicator.

[0225]

[0270] 35. The system of embodiment 33, wherein 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 a proximal end and a distal end, a syringe interior, and a syringe flange at the proximal end thereof, the injection system comprising:

[0275] a stopper member disposed inside the syringe;

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

[0277] a needle connected 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 injection characteristics using a processor in the sensor flange to monitor injection events.

[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 the force-time product of the injection of the 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 the 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 comprises 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 the position, velocity, or acceleration of a plunger member.

[0236]

[0289] 46. ​​The method of embodiment 45, wherein the acoustic sensor is an acoustic reflection sensor, and further comprising the step of the acoustic reflection 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 reflection sensor, and further comprising the step of the acoustic reflection 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 the position, velocity, or acceleration of a plunger member.

[0239]

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

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

[0294] Equipped with leaders,

[0295] Additionally, the method further includes the step of the reader measuring the 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 is a position of a plunger member;

[0301] The method further comprises 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 and

[0306] a light-guiding optical element;

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

[0308] The method further includes the step of the light-directing optical element directing light from the 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 comprises 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 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 the sensor flange is removably coupled to the syringe body;

[0318] the sensor flange issuing an alarm when the injection of the chemical solution is complete to prevent the sensor flange from being discarded prematurely;

[0319] and wherein the sensor flange silences 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 the measured force-time product with a reference force-time product to determine the occurrence of an injection event.

[0251]

[0323] 61. The method of embodiment 60, further comprising the step of the sensor flange 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 comprises a speaker, and the method further comprises the step of the speaker generating an audible sound to communicate with a user administering an injection.

[0256]

[0328] 66. The method of embodiment 65, including 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 alarm, a visual alarm, and / or a 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 as injection event data in non-volatile memory.

[0261]

[0333] 71. The method of embodiment 70, wherein the injection event data further includes an F×t product, an injection execution indicator, a temperature, a speed, a 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 the step of 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 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;

[0341] a needle coupled to the 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 a squirt into the 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 relative to the syringe body to distally insert the stopper member into the syringe interior.

[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 material to reach 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 comprises 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, reward 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, elapsed injection time, injection error-related data, viscosity, temperature, warming time, shear force, residual drug remaining in the syringe, multiple injection site regimen data, 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 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.

[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 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.

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

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

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

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

[0312]

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

[0403] The 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 flanges includes using a first sensor to measure the first injection characteristic and a second sensor to measure the 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 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 a jet into the air.

[0316]

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

[0419] and wherein the processor instructs an output device to output an alarm signal indicating time for 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, wherein the processor further comprises 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 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 c) 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 the step of the sensor flange receiving injection setting data from a computing device via a wireless communication device.

[0327]

[0430] 137. The method of embodiment 136, wherein said injection setting data comprises 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, reward 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] the wireless communication device establishing a connection with a computing device;

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

[0330]

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

[0331]

[0436] 141. The method of embodiment 140, wherein said post-injection data comprises 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, reward 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 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.

[0333]

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

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

[0440] 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 if a coupling status 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 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 down the output device and wireless communication device 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 a completion of 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.

[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, based at least in part on the measured temperature, an approximate time for the injectable material to reach an injection 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 an 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 drops 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 said injection error is 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.

[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;

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

[0472] and an RFID tag configured to be activated at the time of injection.

[0358]

[0473] 168. In the system of embodiment 167, the RFID tag:

[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 cut 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] 168. The system of embodiment 167, 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 the 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 movable proximal end pad;

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

[0494] and a RFID tag.

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

[0498] an RFID processor;

[0499] 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] Distal movement of the proximal end pad 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:

[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 distally 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 illustrate injection systems having manually actuated plunger members, 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 embodiments of greater general applicability. Various modifications may be made to the described embodiments, and equivalents may be substituted without departing from the true spirit and scope of the embodiments. In addition, many modifications may be made to adapt a particular situation, material, composition of matter, process, process acts, or steps to the objective, spirit, or scope of the embodiments. Moreover, those skilled in the art will recognize that each of the individual variations described and illustrated herein has distinct components and features that can be readily separated or combined with the features of some other embodiments without departing from the scope or spirit of the embodiments. All such variations are intended to be within the scope of the embodiments associated with 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 provisioning may be performed by an end user. In other words, the act of "providing" may simply be the act of an end user obtaining, accessing, approaching, locating, configuring, activating, powering on, or otherwise performing an action to provide the necessary equipment for the 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, along with details regarding material selection and manufacturing. Other details of the embodiments will be understood in connection with the above-referenced patents and publications and will be 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 connection with various portions of the device, such as relatively large interfaces of movably coupled parts, to facilitate low-friction manipulation or advancement of such objects relative to other portions of the instrument or nearby tissue structures, as needed. The same may be true with respect to method-based features of the embodiments, as well as with respect to additional actions commonly or logically taken.

[0387]

[0523] Furthermore, while the above embodiments have been described with reference to several examples optionally incorporating various features, these embodiments are not limited to those described or illustrated as contemplated with respect to each variation of the embodiments. Various modifications may be made to the described embodiments, and equivalents (whether recited herein or not included for brevity) may be substituted without departing from the true spirit and scope of the embodiments. Furthermore, when a range of values ​​is provided, it is 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 embodiment.

[0388]

[0524] It should also be understood that any feature of the described inventive variations may be set forth and claimed independently or in combination with any one or more of the features described herein. References to a singular item include the presence of a plurality of the same items. More specifically, as used in this specification and the claims relating thereto, the singular forms "a," "an," "said," and "the" include plural referents unless expressly stated otherwise. In other words, the use of such terms requires "at least one" of the subject item of the claim relating to the above description and this disclosure. It should be further noted that such claims may be written to exclude any element. As such, this description is intended to serve as a prerequisite for using exclusive terminology, such as "only," "only," etc., in connection with the recitation of claim elements or the use of "negative" limitations.

[0389]

[0525] The term "comprising" in claims related to this disclosure that do not use such exclusive language allows for the addition of additional elements or features that are considered to transform 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 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 including a proximal end pad configured to be manipulated relative to the syringe body to insert the stopper member distally into the syringe interior; a needle coupled to a distal end of the syringe body; a sensor flange slidably coupled to the syringe body, the sensor flange comprising: a force sensor for measuring a distal force applied to the proximal end pad; a processor that analyzes the measured distal force to determine the occurrence of an injection event; the sensor flange further comprises a load point configured to receive a distal force applied to the proximal end pad; The system, wherein the sensor flange is configured to slide freely along the syringe body and to transmit the distal force applied to the proximal end pad to the load point of the sensor flange.

2. The system described in claim 1, characterized in that the proximal end pad of the plunger member is configured to be operated simultaneously with the sensor flange to insert the stopper member distally inside the syringe relative to the syringe body.

3. The system described in claim 1, characterized in that the sensor flange has an external housing, and the external housing defines an opening for the load point to protrude from inside the sensor flange to outside the sensor flange.

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

5. The system described in claim 4, wherein the processor is configured to calculate the product of the distal force and the injection time of the dose of medicinal solution to derive a calculated force-time product.

6. The system described in claim 5, wherein the processor is configured to compare the calculated force-time product with a target force-time product to determine the occurrence of the injection event.

7. The system of claim 6 , wherein the target force-time product is predetermined based on at least a viscosity of the medical solution to be injected and a size of the needle.

8. The system of claim 6 , wherein the processor is configured to record a date and time of the occurrence of the injection event.

9. The force sensor measuring the distal force as a resistance or impedance; processing, storing, or transmitting said resistance or impedance as a numerical data point; The system of claim 1 configured to:

10. The system of claim 1, wherein the processor is configured to calculate cumulative force over time.

11. The processor, comparing the calculated cumulative force over time to a target force over time; determining that the injection event has occurred when the calculated cumulative force over time is equal to or greater than the target force over time; The system of claim 10 configured to:

12. The system described in claim 11, wherein the target force over time is a function of the cross-sectional area of ​​the syringe, the target dose, the dynamic viscosity of the drug solution, the length of the needle, and the radius of the needle.

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