Universal dose verification system and method for medical syringes

Abstract

Disclosed are systems and methods for a dosage verification system that can be used by a healthcare professional or an individual self-administering an injection to create a digital record that confirms the dose of fluid medicine drawn into the syringe prior to injection. The dosage verification system includes a medical syringe and an imaging device configured to visualize, selectively capture, process, store, and transmit a digital image of the syringe, thereby enabling the volumetric dose of fluid medicine drawn into the fluid chamber of the barrel to be identified and / or verified prior to injection.

Description

[Technical Field]

[0001] The present application relates to a system and method for quickly and reliably verifying the amount of fluid dispensed into a medical syringe or other patient fluid delivery device prior to administering the fluid to a patient, and providing a visual and digital history of the amount of fluid dispensed. [Background technology]

[0002] The Joint Commission, a U.S.-based nonprofit organization that accredits over 22,000 U.S. healthcare organizations and programs, lists medication administration as one of the top 10 sentinel events. A "sentinel event" is an unexpected occurrence that results in patient death, permanent disability, serious temporary disability, or patient intervention. Identifying medical errors and reducing their occurrence is a major concern in the healthcare and insurance industries. A medical error is a preventable, undesirable effect resulting from a medical procedure, whether obvious or not, and whether or not it results in patient harm. Medication errors are a common cause of medical errors and include administering the wrong medication to a patient or administering the wrong dose of the correct medication.

[0003] Dosing errors can result from errors in calculating the recommended dose based on factors such as the patient's age, weight, and blood glucose level, or from errors in reading the drawn dose on the medical syringe's volumetric scale. Because the desired dose of a medication, such as insulin, can depend on factors such as the patient's real-time blood glucose level immediately before injection, using a factory-prefilled autoinjector to avoid dosing errors is not always practical. For small-volume syringes, such as 1.0 mL and 0.5 mL, the curvature of the barrel associated with the small diameter of a traditional cylindrical syringe makes printing and reading volumetric and related numerical markings difficult. In some cases, the volumetric and related numerical markings wrap around the syringe barrel so far that the user cannot accurately view both simultaneously. Accurately reading the drawn dose under such circumstances can be difficult or impossible for medical professionals, further increasing the likelihood of dosing errors when administering an injection. The potential for such errors is further increased when patients or non-professional personnel prepare their own doses for injections or other administrations.

[0004] Although various protocols have been instituted to reduce such medical errors, such mistakes remain a major concern. In many healthcare facilities, healthcare workers are required to have a second person visually verify the medication solution and the aspirated dose before injecting the patient. Such requirements can place additional strain on clinic and hospital staffing, especially during staffing shortages such as those experienced during the COVID-19 pandemic. Summary of the Invention

[0005] The universal dose verification system and method disclosed herein is believed to reduce the likelihood of medical errors resulting from drawing an incorrect dose of medication into a medical syringe or other needle-based patient fluid delivery device prior to injection or administration. Utilizing the present disclosure may also eliminate the need for one person to draw the dose and a second person to verify the drawn dose. The present invention is suitable for use with medical syringes of various sizes, shapes, and cross-sectional configurations, and with syringes that have a known rated capacity but have opaque barrel walls or barrel walls that lack clearly legible volumetric graduations or numerical markings.

[0006] According to certain preferred embodiments, the system and method selectively capture a digital image of a syringe containing a single dose of medicinal fluid prior to injection and perform at least one process to determine the volume of medicinal fluid in the syringe based on the digital image. As used herein, a single dose generally refers to the amount of medicinal fluid drawn into the syringe immediately prior to injection, but may also include pre-filled syringes in which it is desirable to verify the volume of the pre-filled medicinal fluid for accuracy. In some embodiments, the process of determining the volume of medicinal fluid includes comparing the position of the syringe plunger and the volume of the drawn medicinal fluid to known volumes associated with known positions of the plunger. In some embodiments, known positions of the plunger include a fully extended position relative to the barrel (a substantially full volume position) and a fully inserted position relative to the barrel (a substantially empty volume position). In other embodiments, the process of determining the volume of medicinal fluid includes comparing the position of the plunger to volume markings or volume graduations on the barrel. Various processes, as further detailed herein, may also be used in other embodiments.

[0007] According to other preferred embodiments, a digital image of the syringe containing a single dose of medical fluid may be stored before an injection is administered and may be recalled or accessed at any time in the future for review by a physician or administrative personnel, or to re-verify (or confirm the original verification) the dose drawn for a particular injection, if the need arises. In yet other embodiments, the digital image of the syringe containing the single dose of medical fluid may be linked to a digital processor that may be used to generate reports, upload image data to databases, and for online communication with other healthcare providers, records, and networks.

[0008] In another embodiment, the dose verification system includes a camera, scanner, or other digital imaging device configured to capture, record, store (at least temporarily, but optionally long-term), and optionally transmit, a digital image of a syringe containing a dose, for the purpose of establishing an accurate and reliable historical record of the dose drawn into the syringe or the dose of a filled syringe prior to administration of the medicinal fluid by injection or infusion. In one embodiment, the dose verification system is programmable with application software downloadable and installable on a mobile phone having at least one camera lens and associated programming for assessing the clarity of the image and determining when it is in sufficient focus to provide a reliable digital record confirming the dose.

[0009] In other embodiments, the dose verification system and method includes appropriate lenses, software, and ancillary components, as well as circuitry for focusing, capturing, storing, indexing, retrieving, cross-checking, analyzing, and / or transmitting digital data and images to provide an accurate historical record of the volume of medicinal fluid in the medical syringe prior to injection or infusion, as well as the date and time the dose was drawn. If desired, multiple digital images of the same medical syringe containing the same dose may be acquired and repeatedly analyzed to determine whether a statistically valid and reliable record (within an appropriate standard deviation, confidence level, or other error-checking protocol) is obtained for purposes of verifying the dose in the syringe. Optional data analysis capabilities include cross-referencing with medication records, medical histories, insurance reports, and claims, including typical doses over a period of time.

[0010] In certain embodiments, the aspirated dose of medicinal fluid is determined by directly imaging the fluid level and / or a portion of the plunger, preferably in conjunction with a clearly visible volume scale with numerical or volumetric markings printed directly on the syringe containing the aspirated dose.

[0011] In other embodiments, the level of an aspirated dose of a medicinal fluid contained in a fluid chamber of a syringe barrel having a known rated capacity and in which the barrel wall is opaque or otherwise not transparent, or in which the volumetric graduation markings and numerical indicia are not clearly visible, may be determined by imaging the position of the plunger handle relative to the barrel with the dose in the fluid chamber and calculating (e.g., by ratio / proportional calculation) the apparent volume of the aspirated dose based on known data regarding the plunger position and / or syringe configuration when the fluid chamber is full, or the plunger position when the fluid chamber is empty. In this embodiment, it is sufficient to acquire a single digital image of the syringe with the dose in the fluid chamber. In yet another embodiment, the level of an aspirated dose of a medicinal fluid contained in a fluid chamber may be determined similarly by acquiring at least two images of the syringe: (1) an image capturing the position of the plunger handle relative to the barrel with the dose in the fluid chamber, and (2) a second image capturing the position of the plunger handle relative to the barrel before or after aspirating the dose. In some embodiments, only a portion of the plunger handle may be visible to the imaging device, which may be within or extending from the barrel of the syringe, and in still other embodiments, only the plunger seal of the plunger handle may be visible to the imaging device during dose verification.

[0012] In another embodiment, index markings may be provided on the outward-facing surface of the syringe barrel to define the positions of the plunger handle and plunger seal relative to the barrel when (i) the plunger is fully inserted into the barrel (zero dose or empty) and (ii) the maximum dose (the rated capacity of the syringe) is drawn into the fluid chamber in the barrel (the plunger extends fully outside the barrel). In this embodiment, the digital imaging device of the dose verification system is configured to image the index markings to determine the position of the plunger handle and / or plunger seal relative to the barrel and the corresponding dose of medical fluid drawn into the syringe prior to injection.

[0013] In other embodiments, where the rated volume of the syringe is known (e.g., 1 mL, 0.5 mL, etc.), but the fluid level of the dose drawn into the barrel's fluid chamber is not visible due to other factors, dose verification systems and methods may be configured to image (and measure) the position of the plunger relative to the barrel when the dose is drawn and compare it to the plunger position when the fluid chamber is empty or full, thereby determining the drawn dose using a ratio / proportional calculation.

[0014] In another embodiment, a dose verification system is disclosed that includes a camera, scanner, or other digital imaging device in combination with a specially configured syringe having a flat (or substantially flat) viewing surface. The flat viewing surface allows a camera, scanner, or other digital imaging device (such as a cell phone with camera capabilities) to clearly display and capture an image of the dose drawn into the syringe and the position of the plunger relative to other components of the syringe. In a further preferred embodiment, a volumetric dose scale or volumetric numerical indicia is located on the flat (or substantially flat) viewing surface of the specially configured syringe. In this embodiment, the camera, scanner, or other digital imaging device can clearly display and capture an image of the syringe's total volumetric dose scale, the position of the plunger relative to one or more other components of the syringe, and the medication drawn into the syringe prior to administering the injection or infusion.

[0015] In other embodiments, the level of medical fluid drawn into the fluid chamber of the syringe barrel is determinable from a single viewing position through a single wall of the barrel and from individual markings and / or numbers on the syringe indicating incremental (volumetric) fluid levels within the syringe barrel. Markings and / or numbers associated with the volumetric graduations may be pad printed or molded onto the exterior surface of the syringe.

[0016] In yet other embodiments, the dosage verification system is optionally linked to a database of allowable dosages for a particular medication and patient profile, and a digital or scanned image of the syringe from which the dose was drawn is stored in the dosage verification system. In another embodiment, these digital images may be uploaded, preferably automatically, to a digitized patient record accessible to various authorized user groups, subject to appropriate security measures. Such user groups may include, for example, physicians, nurses, hospital administrators, pharmacy administrators, caregivers, and risk and insurance managers. The digitized patient record, including the uploaded digital images, may also be selectively accessible by the patient through an application downloaded to a mobile device (e.g., a cell phone or tablet) or through a healthcare provider's website.

[0017] In some embodiments, the dose verification system and method may be used with any type of syringe or medication injection device, without the need for a specially configured syringe or injection device.

[0018] In still other embodiments, the dose verification systems and methods may be used with any of the various embodiments of syringes for digital verification of drug liquid volume described herein. These syringes are specialized syringes and injection devices with various features that help facilitate the digital dose verification described herein. For example, in certain embodiments, a digital verification syringe for use with the dose verification systems and methods includes a needle retraction mechanism. The needle retraction mechanism may include a laterally offset needle retraction cavity that is substantially coextensive with the length of the fluid chamber of the syringe barrel. The needle can be selectively retracted after injection by sliding a component of the syringe to change the needle from being substantially aligned with the syringe barrel to being substantially aligned with the syringe's needle retraction cavity. This causes a spring to push the needle rearward into the needle retraction cavity, shielding the sharp leading end of the needle within the needle retraction cavity or by another component of the syringe. Preferably, the needle storage cavity has substantially the same length as the barrel to allow for the use of a longer needle, thereby increasing the range of uses and procedures that can be performed with the syringe without increasing the overall length of the syringe. Depending on the length of the needle, such uses and procedures include, for example, spinal taps, administration of epidural anesthesia, aspiration of cysts, etc., as well as administration of intradermal, subcutaneous, or intramuscular injections.

[0019] In another embodiment, a digital verification syringe for use in the dose verification systems and methods described herein includes a selectively positionable sliding needle safety device that exposes the forward, sharp tip of the syringe needle for injection and then covers it after the injection is complete. The needle safety device according to certain embodiments may include an actuation handle and a needle tip shield connected to the actuation handle. The actuation handle is preferably substantially parallel to the syringe barrel and slidable forward to position the needle tip shield over the needle tip upon completion of the injection. The needle tip shield preferably extends circumferentially around the needle and is configured to be coaxially aligned with the needle. In certain embodiments, the needle tip shield may be connected to or integrally formed with the actuation handle. Needle safety devices according to these embodiments do not require a needle retraction mechanism or cavity to protect the user from an accidental needlestick, nor do they require lateral sliding movement of the barrel relative to the needle. After using the syringe in this embodiment, manual pressure on a touch surface of the actuation handle located behind the needle and needle tip shield selectively advances the needle tip shield to protect the user from the forward-protruding needle tip. In one embodiment, the actuation handle may be slidably engaged with the syringe barrel and is slidable forward relative to the barrel from a first position in which the needle tip is uncovered to a second position in which the needle tip is surrounded by a needle tip shield and protected from accidental needle sticks.

[0020] In yet another embodiment, a digital verification syringe for use in the dose verification systems and methods described herein includes at least one laterally extending wall that extends at least partially longitudinally along or adjacent the syringe barrel and has a generally flat, outwardly facing surface. The outwardly facing surface can be used as a display surface onto which indicia such as dose graduations or numerical volumetric information can be applied using a conventional pad printing process (sometimes referred to as "tampography"); volumetric dose indicia or other markings may be embossed or molded into the generally flat display surface of the syringe. In some embodiments, the laterally extending wall extends laterally from the barrel to both sides of the barrel. In other embodiments, the laterally extending wall extends laterally from the barrel to only one side. In other embodiments, the laterally extending wall is integrally molded with the barrel. In other embodiments, the laterally extending wall, or a portion thereof, forms part of a needle storage cavity.

[0021] In yet another embodiment, a digital verification syringe for use with the dose verification systems and methods described herein includes two laterally extending walls, each having a substantially flat outwardly facing surface, and each wall extending longitudinally at least partially along or adjacent to the syringe barrel. In some embodiments, the two laterally extending walls are correspondingly opposed, laterally spaced apart, and parallel. In some embodiments, both exterior surfaces may have the same or different indicia. Embodiments with two exterior surfaces allow for pad printing without rotating the barrel, even for printing on 1 mL, 0.5 mL, or smaller syringes. The generally flat exterior surfaces also facilitate applying indicia to the syringe by other processes, such as embossing or injection molding.

[0022] In yet another embodiment with two laterally extending walls, the laterally extending walls or portions thereof form part of the needle storage cavity. In one embodiment, the first laterally extending wall forms the upper wall of the needle storage cavity, and the second laterally extending wall forms the lower wall of the needle storage cavity. In yet another embodiment, a third wall connects the outer ends of the upper and lower walls and forms part of the needle storage cavity, and a fourth inner wall forms part of the side wall of the syringe barrel. The needle storage cavity may have a non-circular cross-section.

[0023] In another embodiment with two laterally extending walls, the two laterally extending walls form a recess configured to receive the actuation handle of the needle safety device, allowing the actuation handle to slide forward relative to the walls. In some embodiments, the inner surface of one or both walls is provided with a stop surface that prevents rearward movement of the actuation handle once it has been slid forward, thereby protecting the user from subsequent accidental exposure of the needle tip and associated needlestick injuries. In other embodiments, suitable rails, ramps, stop shoulders and detents, or other similarly effective structures are provided as part of the actuation handle and / or one or both laterally extending walls and / or barrel so that the actuation handle can be smoothly advanced without significant interference, if desired, and will not accidentally retract or slide rearward after moving forward, thereby re-exposing the sharp needle tip.

[0024] In yet other embodiments, a digital verification syringe for use with the dose verification systems and methods described herein includes at least one component colored a different color from the other components. In some embodiments, a portion of the plunger, such as the plunger seal, may be colored a different color from the rest of the syringe to facilitate differentiation of the components in captured digital images. In another embodiment, a portion of the actuation handle of the needle safety device may be colored a different color from the rest of the syringe. In another embodiment, the needle tip shield of the needle safety device may be colored a different color from the rest of the syringe. In yet another embodiment, the needle tip shield and a portion of the actuation handle of the needle safety device may be the same color (e.g., orange) that is different from the rest of the syringe (e.g., a black or blue plunger seal, black or blue volume indicators (if included), and translucent white for all other parts of the syringe).

[0025] In other embodiments, the dose verification system and method may be configured for use with a medical injector having at least one flat or substantially flat, outward-facing indicator surface on a fluid chamber within the barrel. Such an indicator surface may comprise a portion of the sidewall of the syringe's fluid chamber and be integrally molded such that the fluid within the fluid chamber is visible through a single wall rather than through multiple layers of material or wall. In syringes where the liquid level of the aspirated dose is printed or molded onto the indicator surface and is clearly visible through the single wall of the fluid chamber in relation to volume indicia located on or near at least a portion of the fluid chamber, the imaging device may be configured to capture and record the aspirated dose in relation to the corresponding value on the volume indicia.

[0026] In some aspects, the systems and methods described herein relate to an apparatus for injecting a verified dose of a fluid medication, the apparatus including an opaque barrel, a plunger handle with a plunger seal that slidably engages a fluid chamber within the barrel, a hypodermic needle, and an imaging device configured to display, selectively capture, process, store, and transmit at least one digital image of the syringe from which the volumetric dose of the fluid medication drawn into the fluid chamber can be determined.

[0027] In some aspects, the systems and methods described herein relate to a system for injecting a verified dose of a medical fluid, the system including: means for injecting the medical fluid using a syringe having an opaque barrel, a fluid chamber disposed within the barrel, a plunger slidably engaging the barrel, and a hypodermic needle; means for positioning a digital imaging device relative to the syringe; means for aspirating a dose of the medical fluid into the fluid chamber using the plunger; means for displaying, selectively capturing, and storing at least one digital image of the syringe and the medical fluid aspirated into the fluid chamber using the digital imaging device; and means for determining a volumetric dose of the medical fluid by processing the digital image.

[0028] In some aspects, the systems and methods described herein relate to a non-transitory computer-readable storage medium having embedded thereon a set of instructions that, when executed by one or more processors of a computer, cause the computer to perform operations for verifying a dose of fluid medicine drawn into a syringe, the operations including providing a syringe having an opaque barrel, a fluid chamber disposed within the barrel, a plunger slidably engaging the barrel, and a hypodermic needle; providing a digital imaging device configured to selectively display, capture, and store digital images of the syringe including the dose of fluid medicine drawn into the fluid chamber; aspirating the dose of fluid medicine into the fluid chamber; positioning the digital imaging device relative to the syringe; capturing and storing digital images of the syringe and the fluid medicine drawn into the fluid chamber; and processing the digital images to determine the dose of fluid medicine drawn into the syringe.

[0029] In some aspects, the systems and methods described herein relate to a syringe for verifying a volume of a medicinal fluid drawn into the syringe, the syringe comprising: a barrel; a fluid chamber disposed within the barrel and configured to receive a volume of the medicinal fluid drawn into the syringe; and a plunger slidably engaged with the fluid chamber, wherein a first portion of the syringe has a first component and a second portion of the syringe has a second component, the first component and the second component being distinguishable from other portions of the syringe by a processor in a digital image of the syringe to determine a position of the plunger relative to the barrel, which is indicative of the volume of the medicinal fluid drawn into the syringe.

[0030] In some aspects, the systems and methods described herein relate to a system for verifying dosage accuracy of a medicinal liquid, the system comprising: a syringe including a barrel, a fluid chamber disposed within the barrel, a plunger slidably engaging the fluid chamber, and a needle, the syringe configured to aspirate an actual dose of medicinal liquid into the fluid chamber by moving the plunger rearwardly within the fluid chamber; and a first dataset including a predetermined volume ratio of the fluid chamber between a substantially full volume when the plunger is in a fully extended position relative to the barrel and a substantially empty volume when the plunger is in a fully inserted position relative to the barrel, the first dataset configured to be stored in or accessed by a processor for use in a software application that determines the actual dose volume based on a digital image of the syringe after the actual dose has been aspirated into the fluid chamber and the position of the plunger relative to the barrel is between the fully extended position and the fully inserted position.

[0031] In some aspects, the systems and methods described herein relate to a handheld imaging device for verifying dosage accuracy of a medicinal fluid, the handheld imaging device including: a camera configured to selectively capture at least one digital image of a syringe having a barrel, a plunger slidably engaging a fluid chamber in the barrel, and an actual dose of the medicinal fluid in the fluid chamber; and a processor executing a software application configured to determine the actual dose volume of the medicinal fluid based on the at least one digital image of the syringe and provide at least one item of information regarding the actual dose volume to a user.

[0032] In some aspects, the systems and methods described herein relate to a system for verifying dosage accuracy of a medical fluid, the system including a syringe having a barrel, a plunger slidably engaging a fluid chamber within the barrel, and a hypodermic needle, the syringe configured to aspirate an actual dose of medical fluid into the fluid chamber by moving the plunger rearward within the fluid chamber; an imaging device configured to selectively capture at least one digital image of the syringe; and a processor executing a software application for determining the actual dose volume of the medical fluid based on the at least one digital image of the syringe.

[0033] In certain embodiments, a method for verifying a dose of medical fluid drawn into a medical syringe includes the steps of: (1) providing a medical syringe having a barrel, a fluid chamber disposed within the barrel, a plunger slidably engaging an interior wall of the barrel, and a hypodermic needle protruding forward from the barrel; (2) providing a digital imaging device, most preferably a dose verification system, configured to capture a digital image of the dose of medical fluid drawn into the fluid chamber of the medical syringe; (3) aspirating the medical fluid into the fluid chamber of the medical syringe; (4) selectively positioning the digital imaging device relative to the medical syringe containing the aspirated dose of medical fluid; (5) capturing a digital image of the medical syringe; and (6) processing the digital image to determine the actual volume of the aspirated dose. While other digital imaging devices may be used in methods according to embodiments herein, a dose verification system according to embodiments herein is most preferably used in the methods herein.

[0034] According to another embodiment, the method for verifying the dose of fluid medicine drawn into a medical syringe further includes the step of (7) saving the digital image to create a digital record of the dose of fluid medicine drawn. According to yet other embodiments, the method for verifying a dose of a medical fluid drawn into a medical syringe further includes one or more of the following: (8) recalling or retrieving one or more digital images from memory to visually re-verify or confirm the actual dose previously determined by the dosage verification systems and methods described herein for the syringe depicted in the one or more digital images; (9) transmitting data or information related to the actual dose determined by the dosage verification systems and methods described herein to an external device, database, or person (e.g., the user's physician); (10) transmitting the one or more digital images to an external device, database, or person (e.g., the user's physician); and / or (11) generating an alert if the actual dose determined by the dosage verification systems and methods described herein is inaccurate based on a comparison to a set of linked or stored data, which may include prescriptions, medical records, insurance information, and medical device readings (e.g., blood glucose levels measured by a blood glucose monitor).

[0035] According to some embodiments, processing the digital image to determine the actual drawn volumetric dose includes determining the position of the plunger (including the dose of medical fluid in the syringe) relative to another component of the syringe, such as the barrel, and using a predetermined volume ratio of the fluid chamber between a substantially full volume when the plunger is in a fully extended position relative to the barrel and a substantially empty volume when the plunger is in a fully inserted position relative to the barrel. This embodiment is particularly useful when the syringe does not include volume markings and / or the fluid chamber / barrel is not transparent.

[0036] In other embodiments, processing the digital image to determine the actual volumetric dose drawn includes comparing the plunger position (including the volume of the fluid dose in the syringe) to volumetric markings on the syringe (preferably on or adjacent to the barrel). In yet another preferred embodiment, this comparison is coupled using a predetermined volume ratio between the substantially full volume and the substantially empty volume of the fluid chamber based on the plunger position shown in the digital image.

[0037] Use of the dose verification systems and methods described herein reduces the possibility of medical errors resulting from drawing an incorrect dose into a medical syringe prior to injection and provides an accurate historical record in the form of a digital image of the dose drawn into the fluid chamber of the medical syringe, as well as other stored data regarding the dose.

[0038] Other benefits and advantages of the medical device of the present invention as well will become more apparent to those skilled in the art upon reading this specification in conjunction with the accompanying drawings. [Brief explanation of the drawings]

[0039] The systems and methods of the present disclosure are further described and explained in connection with the following drawings.

[0040] [Figure 1] 1 is a top perspective view of an embodiment of a component of a dose verification system according to one embodiment of the present invention, showing a mobile phone with digital imaging capabilities positioned in a use position above a medical injector having a barrel with a flat, upwardly facing outer wall through which a dose of fluid medicine drawn into a tubular fluid chamber disposed within the barrel is visible, along with corresponding volumetric graduations and associated numerical indicia disposed on the flat, upwardly facing surface of the upwardly facing outer wall.

[0041] [Figure 2]Figure 2 is an enlarged plan view of the mobile phone of the dose verification system of Figure 1. The digital image shows a portion of the volumetric scale and associated numerical indicia located on the upwardly facing surface of the outer upward wall of the syringe barrel and overlying a portion of the fluid chamber through which the drawn dose of fluid is clearly visible and indicated by shading.

[0042] [Figure 3] 3 is a top perspective view of another embodiment of components of a dose verification system according to an embodiment of the present invention, showing an adjustably mounted digital imaging device positioned in a use position above a medical injector having a barrel with a flat, upwardly facing outer wall forming an upwardly facing indicator surface having volumetric indicia and associated numerical indicia through which the dose of fluid medicine drawn into the tubular fluid chamber of the syringe barrel is visible.

[0043] [Figure 4] Figure 4 is an enlarged plan view of the digital display of the digital imaging device attached to the dose verification system of Figure 3. The digital image shows a portion of the volume scale and associated numerical markings located on the upward-facing surface of the syringe barrel and overlying the fluid chamber containing the aspirated dose of fluid medication (shown in shading).

[0044] [Figure 5] Figure 5 is a top cross-sectional view of the medical syringe of Figures 1 and 3. The plunger is partially inserted into the barrel to better show the fluid chamber within the barrel, but the injected volume of medical fluid is not shown.

[0045] [Figure 6]6 is a longitudinal side view of a conventional medical syringe having an elongated tubular barrel with a known maximum nominal volume of a cylindrical fluid chamber (e.g., 0.5 mL, 1.0 mL, 2.0 mL, although the volume scale and associated numerical markings have been omitted for ease of illustration, as explained below). The conventional medical syringe has a needle protruding forward from the barrel and a plunger with a plunger seal fully inserted within the barrel.

[0046] [Figure 7] FIG. 7 is a longitudinal cross-sectional view of the plunger of the conventional medical syringe of FIG.

[0047] [Figure 8] FIG. 8 is a side view of one embodiment of components of a dose verification system showing the conventional medical injector of FIG. 6 with a handheld imaging device positioned in a use position, with the plunger partially withdrawn, as would occur after drawing a dose of fluid into the fluid chamber, and with the field of view of the handheld imaging device adjusted to include the entire effective length of the fluid chamber within the barrel.

[0048] [Figure 9] FIG. 9 is another view of the embodiment shown in FIG. 8 except that the barrel is opaque and the handheld imaging device has been repositioned so that its field of view includes the area where the plunger handle protrudes a certain distance rearward from the barrel after the dose of fluid has been aspirated into the barrel.

[0049] [Figure 10] FIG. 10 is a schematic diagram of an embodiment of a dose verification system with an imaging device positioned at a use position above a medical injector, and also shows exemplary accompanying elements of the system arranged in a configuration useful for implementing the functions and methods of operation.

[0050] [Figure 11] FIG. 11 is a top front perspective view of a medical injector with a needle retraction mechanism according to one embodiment of the present invention.

[0051] [Figure 12] 12 is a top front perspective view of the embodiment of FIG. 11 with the needle cover removed.

[0052] [Figure 13] FIG. 13 is an exploded upper front perspective view of the embodiment of FIG.

[0053] [Figure 14] FIG. 14 is a right side view of the embodiment of FIG.

[0054] [Figure 15] FIG. 15 is a cross-sectional view taken along line 305-305 of FIG.

[0055] [Figure 16] 16 is a detailed exploded perspective view, partially cut away, of the front end attachment of the embodiment of FIG. 13, shown alongside the front of the barrel of the embodiment of FIG.

[0056] [Figure 17] 17 is an upper rear perspective view of the front end attachment of FIG. 13. FIG.

[0057] [Figure 18] FIG. 18 is a right side view of the embodiment of FIG. 14 with the plunger cap removed and the plunger retracted to the aspirated position.

[0058] [Figure 19] FIG. 19 is a cross-sectional view taken along line 309-309 of FIG.

[0059] [Figure 20] FIG. 20 is a right side view of the embodiment of FIG. 18 with the needle retracted and the plunger fully advanced into the barrel.

[0060] [Figure 21] FIG. 21 is a cross-sectional view taken along line 311-311 of FIG.

[0061] [Figure 22] FIG. 22 is a front view of the embodiment of FIG.

[0062] [Figure 23] FIG. 23 is a front view of the embodiment of FIG. 22 with the front end attachment repositioned relative to the barrel and the needle retracted to the position shown in FIGS. 20 and 21.

[0063] [Figure 24] FIG. 24 is a top front perspective view of a medical injector with a needle safety device, according to one embodiment of the present invention.

[0064] [Figure 25] FIG. 25 is the syringe embodiment shown in FIG. 24 with the needle cap and plunger cap removed.

[0065] [Figure 26] FIG. 26 illustrates an embodiment of the syringe shown in FIG. 25 in which the needle safety mechanism is moved forward relative to the barrel and needle, and the needle tip shield surrounds and covers the needle tip.

[0066] [Figure 27] 27 is an exploded top perspective view of the syringe embodiment of FIG. 24. FIG.

[0067] [Figure 28] 28 is a side view of the syringe embodiment of FIG. 24. FIG.

[0068] [Figure 29] 29 is a top view of the syringe embodiment of FIG. 24. FIG.

[0069] [Figure 30] FIG. 30 is a cross-sectional view taken along line 420-420 of the figure.

[0070] [Figure 31] FIG. 31 is an opposite side view of the syringe embodiment of FIG. 25 rotated 180 degrees about its longitudinal axis.

[0071] [Figure 32] 32 is a side view of the syringe embodiment of FIG. 26. FIG.

[0072] [Figure 33] 33 is a cross-sectional view taken along the longitudinal axis of the syringe needle of the embodiment of FIG. 32. FIG.

[0073] [Figure 34] FIG. 34 is a bottom view of the syringe of the embodiment of FIG. DETAILED DESCRIPTION OF THE INVENTION

[0074] The dose verification systems and methods described herein are generally useful for determining the actual amount of a dose of a medical fluid drawn by a user or pre-filled into a medical injector immediately prior to use. In the present disclosure, the medical injector used in the systems and methods described herein may be any type of syringe or injection device (also referred to as a "traditional syringe") without special features or structures, such as syringe 95 (FIG. 6), or may be a specialized syringe based on an embodiment of the present disclosure, such as syringe 11 (FIG. 1), syringe 320 (FIG. 11), or syringe 600 (FIG. 24), or may include one or more features or structures of a specialized syringe embodiment of the present disclosure.

[0075] Generally, a medical syringe, whether specialized or conventional, may include a barrel and a plunger with a plunger seal that slidably engages the generally cylindrical inner wall of the barrel to form an adjustable fluid chamber within the barrel. The medical syringe may further include a hypodermic needle disposed in fluid communication with the fluid chamber, protruding forward from the distal (or front) end of the barrel, and having a longitudinal axis generally aligned with the longitudinal axis of the barrel before and during injection. The barrel and plunger are typically made of moldable medical-grade plastic, although other materials may be used in some embodiments; for example, the barrel may be made of glass. The barrel may have volumetric markings to indicate the amount of medical fluid drawn into the syringe.

[0076] Medical injectors used with the presently disclosed dose verification systems and methods may include electronic components, although such electronic components are not required to facilitate determination of the actual dose of medicinal fluid in the injector with the presently disclosed dose verification systems and methods. The specialized injector embodiments disclosed herein are for use with dose verification systems and methods and preferably do not include electronic components.

[0077] 1, 2, and 5, one embodiment of a dosage verification system 10 is shown. The dosage verification system 10 may include a handheld imaging device 20 configured to capture a digital image of a medical injector, such as syringe 11, or a portion of a medical injector. The handheld imaging device 20 may be part of a mobile phone, tablet, or small laptop. The handheld imaging device 20 may include a camera system configured to capture a digital image of at least a portion of the medical syringe containing an actual dose volume of medical fluid (whether drawn immediately before use or pre-filled), a processor configured to process the captured digital image to determine the actual dose volume of medical fluid in the medical syringe (hereinafter referred to as the “actual volume” or “actual dosage / actual dose”), and storage / memory capabilities for optionally storing the captured digital image, application software, and other data used in processing the captured digital image to determine the actual volume of medical fluid. In some embodiments, the processor and application software are preferably further configured to alert the user if the determined actual volume does not correspond to the intended dosage based on various data (such as a prescription or blood glucose readings), In some embodiments, the alert may be visual, audible, tactile, or any combination thereof.

[0078] The handheld imaging device 20 may include a display screen or window 24 that displays an image of an object (e.g., syringe 11) within the field of view 22 of the camera lens of the handheld imaging device 20. It will be appreciated that the dimensions of the field of view 22 may vary depending on the spacing between the syringe 11 and the handheld imaging device 20, as well as the configuration, lens, focal length, and operating mode of the handheld imaging device 20. In the preferred embodiment shown in FIG. 1 , the field of view 22 covers the entire length of the volume scale 25. However, it will be appreciated that the handheld imaging device 20 and associated capture software are capable of capturing an image of the syringe 11 and accurately assessing and / or verifying a dose even when the entire syringe 11 is not within the field of view.

[0079] Preferably, the portable imaging device 20 is configured to be handheld by a user to capture digital images of the syringe. The portable imaging device 20 may be part of a wearable device, such as attached to a headband, eyeglasses, a strap / necklace, or a wrist bracelet / watch, allowing the portable imaging device 20 to capture digital images while worn by the user; however, the portable imaging device 20 is less preferably part of a wearable device that is worn or supported on a part of the user's body other than the hand during use. The portable imaging device 20 need not be part of a wearable device, as it may be carried by the user in an item of clothing, such as a pocket, and would be removed and held in the user's hand during use. Thus, in some embodiments, the portable imaging device 20 may be a mobile phone, tablet, or small laptop computer and configured to be portable. In this manner, the portable imaging device 20, and thus the dose verification system 10, can be used in a variety of locations and are not limited to a particular location.

[0080] As shown in FIG. 1 , a preferred embodiment of syringe 11 includes a wall portion extending laterally from barrel 12 and having an outward-facing indicator surface 15. Indicator surface 15 is substantially flat and may be printed, embossed, or molded with an array of volumetric markings or volume graduations 25 corresponding to the volume within the fluid chamber of syringe 11. In a preferred embodiment of syringe 11, barrel 12 is integrally molded from a transparent or translucent medical-grade polymer and includes volume graduations 25, with incremental markings 34 and associated numerical indicia 36 printed, embossed, or molded into flat, outward-facing indicator surface 15 (the opposite, flat indicator surface 17 is unmarked or unmarked in FIG. 1 ). Incremental markings 34 and associated numerical indicia 36 are positioned in overlapping relation to longitudinally extending cylindrical fluid chamber 62 (see FIG. 5 ) of barrel 12 to facilitate simultaneous visualization of the dose of medicinal fluid 26 within the fluid chamber. The rear side of the fluid chamber 62 is defined by the forward-facing surface 30 of the plunger seal 28 which is attached to a forwardly extending projection 54 on the plunger handle 50 of the plunger 14 .

[0081] Barrel 12 further includes a forwardly projecting hypodermic needle 16 coaxially disposed along cylindrical fluid chamber 62. As shown in Figures 1, 3, and 5, hypodermic needle 16 is biased rearwardly within a laterally slidable front end attachment 18 prior to injection. However, it should be understood that the disclosures herein regarding dose verification systems and methods are not limited to use with medical injectors having retractable or retractable needles and associated mechanisms, but are equally useful with medical injectors with or without other needle safety features, such as those having fixed or detachable needles.

[0082] Cylindrical fluid chamber 62 is surrounded by an inwardly facing, tubular wall of barrel 12, which is integrally molded with outwardly facing, flat indicator surfaces 15, 17. Barrel 12 is sufficiently transparent to light so that forwardly extending end 30 of plunger seal 28 and the medicament 26 drawn into fluid chamber 62 of barrel 12 are visible in conjunction with incremental markings 34 and associated numerical indicia 36 on volume scale 25 in digital image display window 24 (FIGS. 1 and 2) of handheld imaging device 20. Conventional medical syringes have fluid chambers with medium to large volumes (e.g., 5 mL; 10 mL), and the diameter and corresponding circumference of the barrel allow the volume scale markings and associated numerical indicia to be positioned so that both can be easily viewed from a single vantage point. However, for smaller volumes of medical syringes (e.g., 0.5 mL or 1.0 mL), the associated barrel diameter and circumference may be small, resulting in the volume graduation markings and associated numerical indicia wrapping around at least a portion of the barrel's circumference, making both less clearly visible from a single viewing position. This can contribute to medical error when drawing a dose of medicinal fluid into a syringe, further demonstrating the need for the syringe dose verification systems and methods disclosed herein. Printing the volume graduation markings and associated numerical indicia on the barrel of a small syringe avoids the use of pad printing methods and equipment, which are preferred for manufacturing medical syringes at the high production rates necessary to reduce their unit cost. Some syringes may lack volume graduation markings or numerical indicia. Note that syringe 11 does not contain any electronic components.

[0083] As shown in FIGS. 1 and 2, the portable imaging device 20 may be a mobile phone having a camera system and imaging capabilities, a processor, and the ability to utilize application software for processing the captured digital images. In some embodiments, the dose verification system 10 may be configured to selectively capture a digital image of the syringe 11 and display a digital readout 38 of the actual dose value drawn into the medical syringe 11 based on the captured digital image of the syringe 11. The digital readout 38 is preferably a numeric value, such as 0.46 mL. The digital readout 38 may be displayed overlaid on the display window 24 of the captured digital image of the syringe 11, may be displayed without the captured digital image being displayed, and / or may be displayed alongside the captured digital image but without obstructing the view of the captured digital image. The grayscale shading in FIGS. 1 and 2 is intended to illustrate the volume of medical fluid 26 drawn into the fluid chamber of the medical syringe 11. In the enlarged view shown in FIG. 2, the aspirated dose of medical fluid 26 is visible, and the forward-facing surface 30 of plunger seal 28 and a portion of the handle 50 of plunger 14 within barrel 12 (FIGS. 5 and 6) are also visible within digital image viewing window 24.

[0084] In some embodiments, the handheld imaging device 20 may have the capability to capture color images. As such, in some embodiments, the medical injector 11 used with the dose verification system 10 and methods disclosed herein advantageously includes one or more colored components to help image processing or application software in the handheld imaging device 20 recognize or distinguish between different components. In some embodiments, this may improve the accuracy of the dose verification system 10 and / or allow the handheld imaging device and / or associated software to more quickly capture and process digital images of the syringe 11.

[0085] In some embodiments, components associated with a safety feature may be manufactured using materials of a particular color to visually highlight the feature and help indicate its current operating state (e.g., a ready-to-use state with the needle tip exposed, or a used state with the needle tip retracted and / or covered). Such colors or color combinations also help users recognize similar components and states. The components may be any visible color and may be referred to herein simply as "RGB elements," meaning they can be more easily distinguished based on the colors used in the typical red-green-blue pixels of a digital portable imaging device 20, or the colors of the human visible spectrum (including black and white).

[0086] Different components may be selectively colored to create high visual contrast. Thus, in some embodiments, corresponding or related components of syringe 11 and / or imaged components moving relative to one another within syringe 11 may include colors that are considered opposite (or contrasting) to one another on a color wheel, such as black / white, orange / blue, red / green, yellow / purple, and combinations thereof. In some embodiments, corresponding or related components of syringe 11 and / or imaged components moving relative to one another within syringe 11 may include contrasting or distinct grayscale colors or shades. In some embodiments, corresponding or related components of syringe 11 and / or components moving relative to one another within syringe 11 may have contrasting or distinct textures.

[0087] Any number of components with different colors, shades, or textures may be used in the dosage verification system 10 (e.g., two or more different colors, two or more different shades of grayscale, or two or more different textures). Furthermore, any single component may include portions with different colors. For example, the plunger 14 may include a seal 28, a handle 50, and a cap 52, each of which may be a different color. In some embodiments, whether or not there is an array of volumetric markings 36 or volume graduations 25, or whether or not the level of medical fluid 26 in the syringe 11 is fully visible, contrasting or opposing colors can enhance the ability of the handheld imaging device 20 and / or software application to distinguish between different components to accurately verify the dose in the syringe 11. Thus, in some embodiments, the dosage verification system 10 can use the relative positions of distinguishable components to read and / or verify the dose of medical fluid 26 in the syringe 11 prior to administration of the injection.

[0088] In certain embodiments, for example, for a clear fluid in a sufficiently clear barrel 12, image processing software or application software in the dose verification system 10 may determine the actual dose based on the relative position of a portion of the plunger, e.g., seal 28, in a captured digital image of the syringe 11. In another embodiment, the verification system 10 may determine the actual dose of the medicinal fluid 26 based solely on the relative position of a portion of the plunger, e.g., seal 28, in a captured digital image of the syringe 11. Similarly, the image processing software may determine the actual dose of the medicinal fluid 26 based solely on the relative position of the cap 52 in a captured digital image. Thus, in some embodiments, the volume graduations 25 on the syringe 11 (or any syringe used with the dose verification system 10) may not be necessary to determine the actual dose of the medicinal fluid 26. However, it will be understood that in some embodiments, the volume markings 36 or the array of volume graduations 25 may be used in combination with other image features of the dose verification system 10.

[0089] In certain embodiments, for some fluids that have a distinguishable color, the contrast between the color of the fluid and the color of the barrel 12 may be a recognizable feature by the verification system 10 in determining the actual dose. In some embodiments, the plunger 14, plunger seal 28, and / or front surface 30 of the plunger seal 28 may be a different color than the barrel 12, making the position of the plunger 14 within the barrel 12 more easily recognizable in the captured digital image, regardless of the color of the fluid. If the dosage verification system 10 knows the characteristics of the syringe 11, either by identifying the syringe 11 during digital imaging or by a user selecting the particular syringe 11 via a software application on the handheld imaging device 20, the position of the plunger 14 in the captured digital image can be used to determine the actual fluid volume 62 within the barrel 12, even if the plunger 14 itself or the barrel 12 of the syringe 11 does not have volumetric markings.

[0090] In some embodiments, the barrel 12 may be a first color at the front end and a second color at the rear end, such that different portions of the barrel 12 are distinguishable in captured digital images analyzed by the dose verification system 10, regardless of the position of the plunger 14. The barrel 12 may be colored in a gradient ranging from white to black with various shades of gray along the length of the barrel 12. This allows portions of the barrel 12 in a captured digital image to be recognized and measured using image analysis tools, such as the digital imaging device 20, by the visible grayscale portions in the image. Components of the syringe 11 may be formed from materials of substantially the same color, whether homogeneous or heterogeneous. This feature may encourage users to pay more attention to portions of the syringe 11 that are marked with a different color, such as safety features.

[0091] Materials used for components of syringe 11 (or other syringes for digital verification used in dose verification system 10) may have different surface treatments, at least in part, to provide a slightly roughened matte or textured finish. Matte or textured surfaces can more evenly diffuse refracted light, reducing or eliminating reflections and glare that can cause inaccuracies in image analysis software applications. Furthermore, textured surfaces, similar to differentiation using color coding, can distinguish portions of syringe 11 from other portions of syringe 11, aiding in the processing of captured digital images to verify the dose within syringe 11. Thus, in some embodiments, indicator display surface 15 is transparent (or substantially transparent or translucent) and untextured, except for markings 36, while flat display surface 17 facing the opposite direction may be matte and roughened to provide a better background for a clearer view of medication 26 within syringe 11. Incremental markings 36 on volume scale 25 may be colored to enhance their contrast with the medication and barrel 12. In some embodiments, these markings 36 may be printed on laser etched lines that create slightly roughened areas to improve print transferability.

[0092] Handheld imaging device 20 may be positioned at any angle, distance, and / or orientation relative to syringe 11 and capture digital images that are processed to determine the dosage value, as long as syringe 11 is within its field of view (i.e., field of view 22). Furthermore, handheld imaging device 20 need not be positioned substantially perpendicular to syringe 11 in order to capture digital images. Software application embodiments of dosage verification system 10 are preferably configured to compensate for various camera placements (including various angles, distances, or both) relative to syringe 11 when determining the actual dosage from the captured image. Furthermore, software application embodiments may be configured to compensate for movement of handheld imaging device 20 (or the camera of handheld imaging device 20) during image capture. Thus, dosage verification system 10 is desirably configured to compensate for slight hand movements or trembling of the user's hand when using handheld imaging device 20 to capture digital images of syringe 11. These features enable the dose verification system 10 to utilize a handheld portable imaging device 20, such as a cell phone, without the need to mount the imaging device or use a specialized case or mounting device to position the syringe 11 and portable imaging device 20 in a specific spatial relationship.

[0093] While a particular spatial relationship between the handheld imaging device 20 and the syringe 11 is not necessary to capture a digital image and determine the actual dose, the dose verification system 10 may be configured to provide guidance to the user to facilitate improving the spatial relationship in order to improve the digital imaging of the syringe 11. In some embodiments, the dose verification system 10 may execute application software that presents a geometric shape in the display window 24 to assist the user in aligning the handheld imaging device 20 and the syringe 11 for image capture. The geometric shape may include the outline of the syringe 11 or the outline of another syringe similar to the syringe 11. Using the displayed geometric shape, the user can change the angle and distance of the handheld imaging device 20 relative to the syringe 11 so that the displayed geometric shape and the syringe 11 are substantially aligned to capture an improved digital image suitable for processing by the application software. In another embodiment, the displayed geometric shape may be slightly larger than the outline of the syringe 11. This allows the user to position the handheld imaging device 20 above the syringe 11 so that the image of the syringe 11 in the viewing window 24 falls substantially within the displayed geometric shape. Thus, precise alignment of the syringe 11 with the displayed geometric shape in the viewing window 24 is not required for the verification system 10 to accurately determine or verify the actual dose of the medical fluid 26 in the syringe 11.

[0094] 3 and 4 illustrate another embodiment of a dose verification system 75 in accordance with embodiments of the present disclosure. The dose verification system 75 typically includes a digital imaging device 40 that can be mounted by a mechanism such as a hinged support rod 50 to a cart or bed frame in a patient room, medical treatment area, or pharmacy, and is repositionably positioned as needed to allow a user or medical professional to utilize the dose verification system 75 to verify the actual dose of medical fluid 26 drawn into the syringe 11. As previously shown and similarly described in connection with the dose verification system 10, the medical safety syringe 11 includes a barrel 12 with a flat outwardly facing surface 15 that includes a volumetric scale 25 having individual incremental markings 34 and associated numerical indicia 36 and that is positioned overlying a fluid chamber 62 (shown in FIG. 5 ) within the barrel 12. As shown in FIGS. 3 and 4 , digital imaging device 40 includes a display 44 separated by walls 46 and displays images captured within an adjustable field of view 42 focused on an upwardly facing, flat image display surface 15 of barrel 12 of medical injector 11.

[0095] While not shown in FIG. 3 , it should be understood that digital imaging device 40 is operably connected or connectable to a laptop computer or workstation configured to acquire, process, record, store, and transmit captured digital images as needed to verify the actual dose of medical fluid 26 drawn into syringe 11 prior to injection, to activate audio, visual, or tactile alerts as needed to notify the user or a third party if the drawn dose is incorrect (e.g., too high or too low, resulting in a discernible alert), and to create an archivable record of the dose administered in the injection for future use. Thus, a user can locally or remotely access a database containing the captured images (and other data), retrieve the captured images, and verify the dose based on the volumetric scale 25 with incremental markings 34 and associated numeric indicia 36 on the syringe (e.g., barrel, plunger, or other component), with or without text or numeric values ​​as determined by image processing software. Thus, dose verification system 75 may be capable of electronically reporting doses for multiple injections without the need for manual data entry. Additionally, data obtained from the captured image, date and time information, and linked data (e.g., pharmacy records, prescriptions, etc.) may be obtained locally or remotely from an electronic device such as a mobile communication device, tablet, or computer.

[0096] The actual dose may be determined based on geometric data extracted from the captured image by accessing a first dataset containing information describing the syringe dimensions and corresponding syringe volume. The first dataset may include the name of the medication and information identifying the patient receiving the actual dose. The first dataset may include the captured image itself. A second dataset containing a predetermined dose (i.e., the appropriate dose for a particular patient) may be accessed for comparison with the actual dose. The predetermined dose may be based on medical records, including typical doses, medical history, insurance reports, claims, biometric measurements such as blood glucose levels, and / or valid prescriptions. For example, in some embodiments, data from a glucose monitor may be correlated with the predetermined dose required by a diabetic patient. If the actual dose does not match the predetermined dose or the typical dose for a particular time period, an alert may be sent to the patient.

[0097] 3 and 4 , display 44 provides a clear, focused image in a single image of the dose of medical fluid 26 drawn into fluid chamber 62 of barrel 12 forward of front surface 30 of plunger seal 28 of plunger 14. Additionally, in some embodiments, imaging device 40 may include a readout window 48 including an LCD or other display that displays a digital readout of the dose of medical fluid 26. For example, in the illustrated embodiment, imaging device 40 and its associated software application interpret the dose based on the captured digital image, and readout window 48 indicates "0.46" (mL) as the volumetric dose of medical fluid 26 drawn into barrel 12 of medical injector 11.

[0098] The structure and operation of the medical injector 11 are further described and explained in connection with FIG. 5. The medical injector 11 includes a single-piece barrel 12 having two longitudinally extending passages: a fluid chamber 62 defined by a cylindrical inwardly facing wall, and a needle storage chamber 64. The needle storage chamber 64 may be longitudinally coextensive with and laterally offset from the fluid chamber 62, or may share a common wall fluidly separating the fluid chamber 62 and the needle storage chamber 64. The plunger 14 of the medical injector 11 is shown with the plunger handle 50 and plunger seal 28 partially inserted into the barrel 12. With the protective needle cap (not shown) removed, the medical injector 11 is positioned to withdraw a dose of medical fluid 26 from a vial (not shown) into the fluid chamber 62 ( FIG. 5 ). After the hypodermic needle 16 is inserted into a vial of medication 26 or vaccine, the plunger cap 52 of the plunger 14 is pulled rearward, causing the medication 26 to enter a fluid chamber 62 in front of the front face 30 of the plunger seal 28. As shown in the embodiment of FIG. 5 , the safety feature of the syringe 11 is activated by applying lateral finger pressure to a touchpad on the front-end attachment 18 (e.g., a needle safety actuator), which causes the hypodermic needle 16 to move laterally from coaxial alignment with the fluid chamber 62 of the barrel 12 to coaxial alignment with the opening to the needle storage cavity 64. This lateral change in position expands the spring 56 that biases the needle holder 58 carrying the hypodermic needle 16 rearward, forcing the needle holder 58 rearward into the needle storage cavity 64 and also moving the tip of the hypodermic needle 16 rearward until it reaches a position where the needle tip is not exposed after injection and an accidental needle stick cannot occur.

[0099] According to another embodiment, more particularly described below with respect to Figures 6-9, a dose verification system 85 and method of use are provided that can be effectively utilized when a medical syringe 95 has a barrel 112 that does not clearly indicate the drawn dose level, when the volumetric markings or indicia on the barrel 112 are illegible or difficult to read, or even when the barrel wall is opaque. Referring to Figures 6-7, a conventional syringe 95 having a known rated capacity is shown, the syringe 95 having an optically clear barrel 112 without volumetric graduations or other visible numerical markings. In practice, pre-filled syringes exist, where the rated capacity may be displayed on the packaging rather than on the syringe itself. A hypodermic needle 116 projects forward from the barrel 112, a plunger 114 is fully inserted within the barrel 112, and a plunger seal 118 is advanced to abut the front end of the barrel 112.

[0100] Disclosed is a dose verification system 85 used to verify a dose of a medical fluid contained within a fluid chamber 120 of a transparent barrel 112 that lacks visible volumetric graduation markings or associated numerical indicia (similar to a factory-prefilled syringe). Referring to FIG. 8 , the dose verification system 85 includes a portable imaging device, in the illustrated embodiment, a mobile phone 102, equipped with a camera lens 104 and having a field of view 106 positioned to capture and store one or more digital images for recording and storing the medical fluid dose administered prior to injection. The mobile phone 102 may be configured and programmed, for example, using a downloadable software application, to capture and store the digital images and determine from the digital images the position of the plunger 114 relative to the barrel 112 and the scalar distances "A" and "B" shown in FIG. 8 . Distance "A" indicates the distance between the front face of the fluid chamber 120 and the position of the plunger seal 118 after the dose has been drawn. Distance "B" indicates the total length of fluid chamber 120 when plunger 114 is retracted to the "maximum fill position" (corresponding to the maximum rated capacity of syringe 95). Assuming that the maximum rated capacity of syringe 95 is known by the software application through access to a local or remote database, that mobile phone 102 is positioned relative to syringe 95 to bring syringe 95 within field of view 106, and that fluid chamber 120 has the same cross-sectional area over distances "A" and "B" as determined by the software application, the volume of any dose drawn into fluid chamber 120 (less than the maximum capacity) can be determined by multiplying the ratio of A:B by the maximum rated capacity of syringe 95.

[0101] The embodiment described in connection with FIG. 9 discloses a dose verification system 100 used to verify a dose of a medical fluid placed within a fluid chamber of a barrel 122 of a medical syringe 96. In some embodiments, the barrel 122 may be opaque, translucent, textured, or include markings that prevent easy reading of the fluid level inside the fluid chamber of the barrel 122. In some embodiments, the barrel 122 may not include visible volume graduation markings or associated numerical indicia, which also prevents reading of the fluid level within the fluid chamber of the barrel 122. The plunger 114 of FIG. 7 may be used with either the medical syringe 95 (FIG. 8) or the medical syringe 96 (FIG. 9), which may have the same or substantially the same maximum rated capacity.

[0102] Referring to FIG. 9, a dosage verification system 100 includes a portable imaging device, which in the illustrated embodiment includes a mobile phone 102 with a camera lens 104 having a field of view 108. The camera lens 104 is positioned to capture and store one or more digital images from which the volume of the administered dose of medical fluid can be determined and recorded prior to injection. The mobile phone 102 may be configured and programmed, for example, using downloadable application software to capture and store the digital images, from which the position of the plunger 114 relative to the barrel 112 and the scalar distances "D1" and "D2" shown in FIG. 9 can be determined. In FIG. 9, the scalar distance "D1" represents the distance from the barrel flange 126 to the thumb cap 124 of the plunger 114 when the plunger 114 is fully inserted into the barrel 122 of the syringe 96 and the volume associated with the fluid chamber within the barrel 122 is zero. In contrast, scalar distance "D2" represents the distance from barrel flange 126 to thumb cap 124 of plunger 114 when plunger 114 is retracted after aspirating the dose of medicinal fluid to be administered into barrel 122. Assuming that the maximum rated capacity of syringe 96 is known by the software application through local or remote access to a database, that mobile phone 102 is relatively positioned to bring syringe 96 within field of view 108, and that the cross-sectional area of ​​the fluid chamber within barrel 122 is the same over the distance plunger 114 is retracted prior to injection, as determined by the software application, the volume of the dose aspirated into the fluid chamber of barrel 122 is the ratio of "D2" minus "D1" ((D2-D1) / Length) to the total length of the fluid chamber of barrel 122 when it is filled to its maximum rated capacity (distance "B" described above with respect to syringe 95 of FIG. 8). FC ) by the maximum rated capacity of the syringe 96.

[0103] 10 shows a schematic diagram of a dose verification system 200. The dose verification system 200 may generally be configured to verify and create a historical record of the dose of medical fluid drawn into a fluid chamber of a medical injector prior to administering an injection. The dose verification system 200 may include a handheld imaging device 202 positioned to view and capture a digital image of the syringe 206 within a field of view defined by boundaries 208, 210, as described above for fields of view 22, 42, 106, and 108 in connection with FIGS. 1-9.

[0104] In one embodiment, the handheld imaging device 202 is configured by application software 204 to focus and capture clear images of the indicia display surface and volumetric scale (both the individual indicia and their associated numbers) on the barrel of the syringe 206 relative to the dosage of medical fluid drawn into the fluid chamber within the barrel of the syringe 206, as described above in connection with FIGS. 1-9 . The application software 204 may be downloadable to a handheld imaging device 202, such as a mobile phone, tablet, or laptop, that has digital imaging capabilities or is accessible via Wi-Fi, the Internet, or other known technologies. In one embodiment, the application software 204 may comprise a digital signal processor 205 or other known processing equipment and circuitry, which controls and processes the digital images viewed and captured by the imaging device 202 and transmits the images to a display device 216, a storage device 220, or a recording medium (any of which may be external or incorporated within the imaging device 202), or may be operatively linked by a transmitter 212 and / or a report generator 222 to a separate, archivable, indexed database.

[0105] According to some embodiments of the dosage verification system 200, the digital image viewed and captured by the imaging device 202 is optionally analyzed with respect to predetermined parameters by a comparator 214 or other similarly effective device or circuitry (with or without transmission to an external device) configured to generate a visual, audible, or tactile alert 218 informing the user that the dose of medicinal fluid drawn into the syringe 206 is correct. In some embodiments, the dosage verification system 200 may be configured to generate a visual, audible, or tactile alert 218 informing the user if the dose of medicinal fluid drawn into the syringe 206 is more or less than the prescribed or scheduled dose. Similarly, the dosage verification system 200 may be configured to image the dose in the same syringe 206 multiple times consecutively within a short period of time to ensure that the dose of medicinal fluid determined from the captured images is accurate, reproducible, and consistent within acceptable limits. In some embodiments, the dosage verification system 200 may record the date, time, and / or location at which the injection was administered along with the dosage information. In some embodiments, the captured digital images may be stored locally on the digital imaging device 200 and / or uploaded to a cloud computing system or other database, allowing for selective retrieval of the data in the future for dosage verification or treatment history review.

[0106] In general, when components of the described technology are implemented in whole or in part using software in one aspect, these software elements may be implemented to operate in conjunction with a computing component or one or more processing components capable of performing the described functions. Even when various functions or elements are individually described or claimed as separate components, those skilled in the art will understand that these features and functionality may be shared among one or more common software and hardware elements. Thus, imaging device 202 is an exemplary computer component that may in fact represent multiple such components.

[0107] The application software 204 may be executed by computing or processing capabilities present in, for example, a desktop, laptop, notebook computer, handheld computing device (such as a personal digital assistant (PDA), smartphone, cell phone, palmtop, etc.), mainframe, supercomputer, workstation, server, or other type of special-purpose computing device desired or appropriate for a particular application or environment. The processing may be implemented using a special-purpose processing engine, such as, for example, a microprocessor, controller, or other control logic. Such processing may also include one or more memory components, such as a random access memory (RAM) or other dynamic memory, for storing information and instructions executed by the processor.

[0108] Thus, storage 220 may include any fixed or removable media that is read, written, or accessed by application 204. As these examples illustrate, storage 220 may include non-transitory computer-readable storage media having computer software or data stored or embedded therein. The terms “computer program medium” and “computer usable medium” are used generally to refer to media such as storage 220. This and various other forms of computer program medium or computer usable media may be used to carry one or more sequences of one or more instructions to a processor for execution. Such instructions embodied in a medium are commonly referred to as “computer program code” or a “computer program product” (which may also be grouped in the form of a computer program or other grouping). When executed, such instructions may cause system 200 to perform the features or functions of the disclosed technology as described herein.

[0109] Referring to FIG. 11 , a medical injector 320 according to one embodiment of the present invention is shown. The medical injector 320 includes a needle retraction mechanism and includes a needle cover 326 (including a locking member 340) and a plunger end cap 330 mounted in a position that allows the syringe 320 to be safely packaged, shipped, and stored. In this configuration, the locking member 340 of the needle cover 326 may limit lateral sliding movement of the front end attachment 324 relative to the barrel 322 prior to use. The syringe 320 may include a barrel 322 including a generally flat viewing surface 323, a front end attachment 324, an outer wall 325 of a fluid chamber 375 (shown in FIG. 19 ), a selectively removable needle cover 326, an array of volumetric indicia 327, a finger flange 328, a removable plunger cap 330, and the locking member 340. As shown in FIG. 11 , primary volumetric indicia 327 are applied to the generally flat viewing surface 323 and include, for example, at least a number identifying the number of fluid units and an associated primary measurement indicator. However, it will be understood that the accompanying figures are for illustrative purposes only, and that the placement of some features, such as the secondary unit markings 327, relative to the generally flat viewing surface 323 may vary from the placement shown. At least a portion of the secondary unit markings 327 may begin at or near an edge of the generally flat viewing surface 323, and may optionally continue at least a short distance onto the curved outer wall 325 of the fluid chamber. Such placement is understood to be within the capabilities of known pad printing technology and is presently within the understanding of one of ordinary skill in the art.

[0110] In some embodiments, an adhesive sticker (not shown) may be applied to the front of the barrel 322 or to a portion of the flat display surface 323 (described below with respect to FIG. 19 ) extending laterally from the barrel 322 without interfering with dose volume measurement. The sticker may contain information about the medication, such as a pharmacy label, or a QR code for remote access to that information. In some embodiments, the flat portion extending from the side of the barrel 322 may be laser etched to create a slightly roughened area, which improves sticker adhesion. The roughened area may better retain ink for printing the secondary unit markings 327. Indications printed on the flat display surface 323 may be useful in some embodiments to ensure proper orientation of the barrel 322 and front end attachment 324 during manufacturing, or for proper connection of a separate needle connected to the barrel 322 during use.

[0111] In FIG. 11 , the front end attachment 324 of the syringe 320 is shown in a “pre-use” configuration. Before use, the needle cover 326 and locking member 340 are positioned to prevent the front end attachment 324 from moving laterally relative to the barrel 322, as pressure may inadvertently be applied to the textured touchpad 346 or the opposite surface of the barrel 322. To prevent the plunger (not shown) from being accidentally withdrawn from the barrel 322 and to prevent inadvertent contamination within the rear opening of the barrel 322 or around the rearwardly extending handle portion of the plunger (see FIG. 19 ), a removable plunger cap 330 is provided behind the finger flange 328, as described below. The finger flange 328 includes a flat portion that helps keep the syringe 320 positioned horizontally on a surface without rolling when an image is being captured.

[0112] 12, 14-15, and 22, the barrel 322 and front end attachment 324 of the syringe 320 are shown in the same position as in FIG. 11, except that the needle cover 326 (with locking member 340) has been removed. The front opening of the needle storage cavity 392 is shown, and the needle 334 projects forwardly from the needle support member 332 of the front end attachment 324. A plurality of circumferentially spaced, axially tapered ribs 333 are disposed around the needle support member 332 to provide a surface for frictional engagement with the inner surface of the needle cover 326 prior to removal. In FIG. 12, the needle 334 is coaxially aligned with a longitudinal axis passing through the fluid chamber 375 (FIG. 19).

[0113] 13, the needle cap 326 of the syringe 320 further includes a forward-facing, inwardly tapering, generally cylindrical sidewall having a front end 336, a rearward-facing annular collar 338, and a locking member 340 projecting rearwardly from the annular collar 338. The front end attachment 324 further includes a forwardly projecting, generally tubular needle support member 332 having a front opening 342, an upper guide member 344, a lower guide member 345 (see FIG. 17), and a laterally projecting textured touch pad 346.

[0114] Syringe 320 includes a needle 334 having a forward-facing, beveled needle tip 348 and a needle retraction mechanism including a compression coil spring 350 and a needle holder 352. Needle holder 352 includes an elongated shaft 354 with a tubular bore 358 into which the rear of spring 350 can be inserted. The diameter of a head 356 of needle holder 352 is sufficiently larger than the inner diameter of spring 350 so that spring 350 is held in a compressed state by head 356 when front end attachment 324 slidably engages front portion 64 of barrel 322, as described below in connection with Figures 16 and 17. The rear end of needle 334 is insertable into tubular bore 358 of needle holder 352 and is fixedly attached to the interior of elongated shaft 354 by any suitable means, such as adhesive. While the needle retraction mechanism disclosed herein is sufficient for use within the syringe 320, it will be understood that other similar elements and mechanisms may be used that provide a similar effect and are useful for biasing the needle 334 rearward within the syringe 320.

[0115] 13, an annular polymeric fluid seal 60 having a tubular bore 362 is insertable into a recess 66 in the front portion 364 of the barrel 322. When the needle retraction mechanism is disposed within the front end attachment 324 and the front end attachment 324 is slidably engaged with the front portion 364 of the barrel 322, the forward-facing end of the seal 360 abuts the rearward-facing head 356 of the needle holder 352. During manufacture, when the front end attachment 324 of the syringe 320 is assembled to the front portion 364 of the barrel 322, a continuous, generally linear fluid flow path is formed through the needle 334, the needle holder 352, and the annular fluid seal 360 and into a tubular, longitudinally extending fluid chamber 375 (see FIG. 19).

[0116] In addition to the front portion 364, the barrel 322 further includes a generally flat display surface 323, a curved outer wall surface 325, a finger flange 328, and a rearwardly projecting annular collar 370. To assemble the syringe 320, an elastomeric plunger seal 376 is placed on a forwardly projecting boss 374 at the front end of the plunger handle 372 opposite the rearwardly facing plunger thumb pad 378, and the plunger handle 372 is then inserted into the rearwardly facing opening defined by the annular collar 370. Assembly of the syringe 320 is completed by attaching a generally cylindrical plunger cap 330 to the rearwardly facing end of the barrel 322. The plunger cap 330 further includes an open front end 380, a cylindrical bore 382, ​​and a closed rear end 384. The plunger cap 330 fits around the plunger thumb pad 378 and frictionally engages the outer wall of the annular collar 370. Volumetric indicia 327, as described in connection with FIG. 11, are also found on the generally flat viewing surface 323 and the outwardly facing portion of the curved outer wall surface 325.

[0117] 13, 16 and 21 further illustrate the forward opening into needle storage cavity 392 relative to the front 364 of barrel 322. Needle storage cavity 392 has a closed rear end adjacent finger flange 328 and is bounded by side wall 390, side wall 395, bottom wall 394, and top wall, which also includes the upwardly facing, generally flat, viewing surface 323 of barrel 322.

[0118] The assembly of the front-end attachment 324 to the front portion 364 of the barrel 322 of the syringe 320 will be further described with reference to FIGS. 16 and 17. Referring to FIG. 16, first, the annular fluid seal 360 (see FIG. 13) is inserted into the recess 366 in the front portion 364 of the barrel 322. The front portion 364 further includes upper and lower rails 368, 369 extending laterally, which are disposed transversely relative to a longitudinal axis passing through the fluid chamber 375 ( FIG. 19 ) of the barrel 322. Rounded mounting guides 396, 398 are disposed forward of the upper and lower rails 368, 369, respectively, and the front-end attachment 324 is configured to be assembled to the front portion 364 of the barrel 322 by passing the upper and lower arms connected to the textured touchpad 346 up and down to the rear surface of the front-end attachment 324.

[0119] 17, an annular opening 412 is provided in the rear of front end attachment 324 to allow for the insertion of spring 350 and needle holder 352, as described with respect to FIG. 13. Spring 350 is compressed between annular shoulders (see FIG. 21) within front opening 342 and is held compressed behind head 356 of needle holder 352 while front end attachment 324 moves front portion 364 of barrel 322 into sliding engagement. Front end attachment 324 further includes upper guide 344 having a downwardly facing, laterally extending recess 400 and lower guide 345 having an upwardly facing, laterally extending recess 402. The upper ramp portion 404 and the lower ramp portion 406 of the front end attachment 324 each have blocking shoulders 377, 379 and are configured to slide over two sets of laterally spaced, opposing ramp portions (the lower set is not visible in FIG. 16).

[0120] 16, sliding the front-end attachment 324 onto the front 364 of the barrel 322 causes the laterally extending upper and lower rails 368, 369 of the front 364 of the barrel 322 to cooperatively engage with the upper and lower recesses 400, 402, respectively. When pressure is applied to the textured touch surface 346, the front-end attachment 324 moves along the rails 368, 369, and the upper and lower blocking shoulders 408 of the upper guide 344 pass through and then face the upper and lower blocking shoulders 377. At this time, the needle support member 332 and the needle holder 352 (not shown in FIGS. 16 and 17) are coaxially aligned with the longitudinal axis of the fluid chamber 375 (see FIG. 19). Because the upper and lower blocking shoulders 377 of the front section 364 face and contact the upper and lower blocking shoulders 408, 410 of the front end attachment 324, any attempt to return the front end attachment 324 to the separated position (FIG. 16) will not return.

[0121] 14 and 15 show the syringe 320 of FIG. 12 with the needle cover removed, the plunger cap 330 in place, and the textured touch surface 346 in the initial position described above relative to the barrel 322. The needle 334 is disposed in an inner bore 358 of a needle holder 352 mounted within the needle support member 332 of the front-end attachment 324, with a spring 350 compressed between the head 356 (FIG. 13) of the needle holder 352. The needle holder 352 and needle 334 are biased rearward by the spring 350, which urges them against and abuts the front face of an annular fluid seal 360. This establishes a coaxially aligned fluid passageway through the needle 334, needle holder 352, and fluid seal 360 to a fluid chamber 375 (see FIG. 19) in the generally cylindrical barrel 322. As shown in FIGS. 14 and 15, plunger seal 376 is pushed fully forward into the generally cylindrical fluid chamber 375 of barrel 322 .

[0122] 18-19, the syringe 320 is configured for fluid aspirating, with the textured touchpad 346 in the initial position described above. The plunger cap 330 (see FIGS. 12, 14-15) has been removed, and the plunger handle 372 is retracted, as if for aspirating fluid into the fluid chamber 375. In FIG. 19, the needle storage cavity 392 is approximately the same length as the fluid chamber 375. This allows the volumetric indicia 327 to be positioned on a substantially flat surface 323 (see FIG. 13), thereby fully utilizing the volume of the fluid chamber 375 and also permitting the retraction of needles, such as biopsy needles, that are significantly longer than the needle 334 (seen in the needle storage cavity 392 in FIG. 21). Once fluid has been aspirated into the fluid chamber 375, the fluid can be injected into a patient or expelled from the fluid chamber 375 by pressing the plunger thumb pad 378 forward and applying digital pressure against the forward-facing surface of the flange 328.

[0123] 20-21 and 23, the plunger handle 372 and plunger seal 376 are pushed forward to empty the fluid chamber 375. To initiate needle retraction, pressure is applied to the textured touch pad 346, which moves the front end attachment and aligns the needle support member 332 with the needle storage cavity 392. Because the front opening of the needle storage cavity 392 is larger than the head 356 of the repositioned needle holder 352, the needle holder 352 is pushed rearward by the biasing force of the compression spring 350, and the needle holder 352 and needle 334 are advanced into the distal end of the needle storage cavity 392.

[0124] 16 and 17, when further force is applied to the textured touch surface 346 of the front end attachment 324 relative to the barrel 322 described with reference to FIGS. 20-21, the front end attachment 324 and the front portion 364 of the barrel 322 slide relative to each other. This movement causes the upper and lower sloped surfaces 404, 406 to slide past the second set of opposing ramps and blocking shoulders 379, so that the upper and lower blocking shoulders 408, 410 abut against the upper and lower blocking shoulders 379. This prevents the front end attachment 324 from returning to the use position relative to the barrel 322.

[0125] 24-34 generally, and 24-27 specifically, a syringe 600 according to one embodiment of the present invention is shown. The syringe 600 is shown with a needle safety device 612. The syringe 600 may include a barrel 610, a needle safety device 612, a needle cap 614, and a plunger cap 616. In FIG. 24, the syringe 600 is shown with the needle cap 614 and plunger cap 616 both installed, as they appear when the syringe 600 is first removed from its packaging. The barrel 610 includes at least one longitudinally extending, generally planar indicator surface 620 with easily readable volumetric indicia. In one embodiment, the barrel 610 includes two opposing, generally planar indicator surfaces 620, 636 (FIG. 26). Removing needle cap 614 and plunger cap 616 (FIG. 24) from the device reveals a forwardly projecting needle 625 and a rearwardly projecting plunger 624 (FIG. 25). Needle 625 is coaxially aligned with plunger 624 and is fixedly held in a narrow bore 650 inside nose 634 (FIGS. 26, 27, 30) at the forward end of barrel 610. (Alternatively, it will be appreciated that needle 625 and nose 634 may be cooperatively configured, with needle 625 removably attached to nose 634, if desired, to allow needles of various sizes to be used with barrel 610.)

[0126] The bore 650 places the needle 625 in fluid communication with a fluid reservoir located within the tubular barrel 658 between the nose 634 and a plunger seal 660 at the forward end of the plunger handle 640. When the plunger handle 640 is pushed fully forward against the rear end of the nose 634 of the barrel 610 before ( FIG. 30 ) or after ( FIG. 33 ), the fluid chamber is not visible. As will be described below, when the syringe 600 is primed for injection, the fluid reservoir is the space (not visible in these views) within the tubular portion 658, which is between the rear of the nose 634 and the front of the plunger seal 660 when fluid is drawn into the syringe 600.

[0127] Referring to FIG. 27, the needle safety device 612 also includes an actuation handle 628 and a needle tip shield 632. The actuation handle 628 further includes a rear end 668, a touch pad 626, and a pair of longitudinally extending channels 627 located on either side of the actuation handle 628. The function of the channels 627 will be described below in connection with its sliding engagement with the barrel 610. The needle tip shield 632 further includes an inner bore 648 that is coaxially aligned with the needle 625 and with the nose 634 of the barrel 610. The needle tip shield 632 has an inner diameter that allows the needle tip shield 632 to slide around the coaxially aligned nose 634 when in the position shown in FIGS. 25 and 31, and is long enough to safely cover the tip of the needle 625 when moved forward as shown in FIGS. 26 and 32-33. A slight frictional engagement between the inner wall of the needle tip shield 632 and the nose 634 may be provided to hold the needle safety device 612 in an axially stable position relative to the barrel 610 during use of the syringe 600. The needle safety device 612 is unitarily molded from a polymeric material and cooperatively sized and configured to slidably engage with the barrel 610, taking into account the range of needle lengths intended for use with the syringe 600. In certain embodiments, the needle safety device 612 is made from a brightly colored (e.g., red) material to highlight its presence and state of use to the user.

[0128] Referring again to FIG. 27, barrel 610 further includes a coaxially aligned nose 634 having an internal bore 650 and a tubular portion 658 extending rearwardly from nose 634 to fingertip flange 618. The rearward end of tubular portion 658 is open and communicates with the interior of a cylindrical, rearwardly extending collar 630, to which plunger cap 616 is removably attached. Opposite indicia display surfaces 620, 636 (FIG. 26) are preferably parallel, longitudinally extending, substantially flat, printable surfaces, each having opposing volumetric graduations with appropriate indicia disposed adjacent tubular portion 658 to allow a user to easily read the liquid level within tubular portion 658. A longitudinally extending rail 656 having an inwardly protruding retention edge 654 is provided on the inward-facing wall of each of the outwardly facing indicia display surfaces 620, 636. The longitudinally extending rails 656 are cooperatively sized to provide a smooth, slidable interface along each of the aligned channels 627 of the needle safety device 612. The barrel 610 is molded from a medical-grade polymeric material and is sufficiently transparent to allow a user to clearly view the level of fluid drawn into the tubular portion 658 of the syringe 600. Additionally, with reference to FIG. 27 , the plunger 624 further comprises a thumb cap 638, a plunger handle 640, a plunger seal retainer body 666, and an annular recess 664.

[0129] The cooperatively configured structural elements and operation of the needle safety device 612 relative to the barrel 610 of the syringe 600 are further described and illustrated in connection with Figures 25-27, 30, and 32-33. During assembly of the syringe 600, the actuation handle 628 of the needle safety device 612 is aligned with and inserted over the tubular portion 658 of the barrel 610, with the rail 656 engaging the channel 627. As the needle safety device 612 moves rearwardly relative to the barrel 610, the needle tip shield 632 surrounds the nose 634 of the barrel 610 and the rear end 668 of the needle safety device 612 frictionally engages the oppositely disposed rear stop 646. The sliding stop 642 has a ramp portion 644 and a stop shoulder 652, which are located rearward of the rail 656 and forward of the rear stop 646. Oppositely disposed ramps 644 allow the actuation handle 628 to slide forward relative to the barrel 610 to a position where the needle tip shield 632 covers and protects the tip of the needle 625 after use of the syringe 600. After the tip of the needle 625 is covered, oppositely facing stop shoulders 652 prevent the actuation handle 628 from moving rearward relative to the barrel 610 and re-exposing the needle tip.

[0130] 25 and 30-31 relative to the barrel 610 and needle 625 (referred to as the "first stop position"), the needle tip shield 632 surrounds the nose 634 of the barrel and a portion of the needle 625. When the needle safety device 612 of the syringe 600 is in the first stop position, the tip of the needle 625 can be inserted through the stopper of a medicine vial (e.g., an insulin bottle) and the plunger 624, which slidably engages the inner wall of the tubular portion 658, can be pulled rearward to aspirate medication into a fluid reservoir located within the tubular portion 658 of the barrel 610 (FIGS. 27 and 30).

[0131] Following an injection or other use of the syringe 600, the syringe 600 can be reconfigured to a "safe" configuration in which the needle tip is covered and protected from inadvertent contact with a healthcare professional or patient by selectively moving the needle safety device 612 forward to the position shown in Figures 26 and 32-33 (the "second stop position"). When the syringe 600 is configured with the needle safety device 612 in the second stop position, the tip of the needle 625 is circumscribed by the needle tip shield 632, and the front end of the needle tip shield 632 extends well forward of the tip of the needle 625 (as shown in Figures 26 and 33), preventing a person from suffering an unintentional needlestick injury even if the front end of the syringe 600 is pressed against the skin.

[0132] In various embodiments herein, an imaging device or camera can be used to capture images of a syringe with an aspirated dose without requiring a fixed stage area for the syringe or a camera stand to hold the camera at a fixed or selected distance or angle relative to the syringe. Furthermore, the surface on which the syringe with the aspirated dose is placed does not need to have any special shape or markings to capture the image. A substantially flat surface, such as a tabletop, is sufficient. The syringe to be imaged for dose verification may be held in the user's hand, and the imaging device may be held in the other hand. Images for dose verification may be acquired without the need for special lighting, such as specific wavelengths or colored lighting, or special camera filters, such as polarizing filters. Sufficient images may be captured using only ambient light, a cell phone's built-in flashlight, or camera hardware commonly found in commercially available smartphones.

[0133] The embodiments described herein with respect to doses drawn into a syringe may also be applied to prefilled doses. While prefilled doses are generally accurate, it may be desirable to utilize a dose verification system or method according to embodiments herein to confirm the accuracy of the prefilled dose and / or to confirm that the particular prefilled syringe selected for injection or administration is the correct syringe based on the prescribed dosage or patient medical data (e.g., to detect when a user mistakenly selects a 1 mL prefilled syringe when the prescribed dose is 2 mL and a 2 mL prefilled syringe should have been selected). In such embodiments, the syringe containing the prefilled dose may not include a needle, but may be configured to have a needle attached to the syringe using various methods disclosed herein or other methods known in the art.

[0134] Ancillary components of the dosage verification systems and methods according to various embodiments herein may include a digital processor, digital storage media, report generation software, and radio frequency, Bluetooth, and / or Wi-Fi transmitters.

[0135] It will be understood that the systems and methods disclosed herein may include one or more of the following embodiments, alone or in combination with other embodiments.

[0136] Embodiment 1. A syringe for verifying a volume of medicinal liquid drawn into the syringe, the syringe comprising: a barrel; a fluid chamber disposed within the barrel and configured to receive the volume of medicinal liquid in the syringe; and a plunger slidably engaged with the fluid chamber, wherein a first portion of the syringe has a first component and a second portion of the syringe has a second component, the first component and the second component being distinguishable from other portions of the syringe in a digital image of at least a portion of the syringe by a processor to determine a position of the plunger relative to the barrel that is indicative of the volume of medicinal liquid drawn into the syringe.

[0137] Embodiment 2. The syringe of embodiment 1, wherein the barrel does not have volumetric markings.

[0138] Embodiment 3. A syringe of any one of embodiments 1 to 2, wherein the plunger does not have volume markings.

[0139] Embodiment 4. The syringe of any of embodiments 1 to 3, wherein the first component and the second component are RGB components.

[0140] Embodiment 5. The syringe of embodiment 4, wherein the first and second components are in contrast to the remainder of the syringe.

[0141] Embodiment 6. The syringe of any of embodiments 1 to 5, wherein the first component is a first color and the second component is a second color.

[0142] Embodiment 7. The syringe of embodiment 6, wherein the first color contrasts with the second color.

[0143] Embodiment 8. The syringe of any of embodiments 6 to 7, wherein the first color and the second color contrast with the rest of the syringe.

[0144] Embodiment 9. The syringe of embodiment 6, wherein the first color and the second color are substantially the same.

[0145] Embodiment 10. The syringe of any one of embodiments 6 to 9, wherein the first color is red.

[0146] Embodiment 11. The syringe of any one of embodiments 6 to 9, wherein the first color is orange.

[0147] Embodiment 12. The syringe of any one of embodiments 6 to 11, wherein the first color is different from the second color.

[0148] Embodiment 13. The syringe of any of embodiments 6 to 9 or 12, wherein one of the first color and the second color is orange.

[0149] Embodiment 14. The syringe of embodiment 13, wherein the other of the first color or the second color is blue.

[0150] Embodiment 15. The syringe of any one of embodiments 1 to 14, wherein the barrel is opaque.

[0151] Embodiment 16. The syringe of embodiment 15, wherein the barrel has no volumetric markings.

[0152] Embodiment 17. The syringe of any one of embodiments 1 to 16, wherein the first portion comprises the front end of the barrel and the second portion is disposed at the rear end of the barrel.

[0153] Embodiment 18. The syringe of any of embodiments 1 to 17, further comprising: a first wall extending laterally from the barrel; a second wall extending laterally from the barrel and parallel to the first wall; a channel formed between the first wall and the second wall; a needle safety device configured to slide from a first rearward position to a second forward position and including an actuation handle at least partially disposed within the channel; and a needle tip shield connected to the actuation handle, wherein when the actuation handle is in the first rearward position, the needle tip shield surrounds the nose of the barrel, and when the actuation handle is in the second forward position, the needle tip shield surrounds the front end of the needle connected to the nose, and the second portion is a rear portion of the actuation handle.

[0154] Embodiment 19. The syringe of embodiment 18, wherein at least one of the first wall or the second wall has a substantially flat outer surface that allows the syringe to be placed on a surface without rolling.

[0155] Embodiment 20. The syringe of embodiment 19, further comprising a plurality of volumetric markings disposed on the generally flat outer surface and adjacent the barrel.

[0156] Embodiment 21. The syringe of embodiment 20, wherein the barrel is sufficiently transparent to allow the medicinal liquid to be seen through the barrel.

[0157] Embodiment 22. The syringe of embodiment 1, wherein the barrel is colored with a partially transparent gradient scale.

[0158] Embodiment 23. The syringe of embodiment 22, wherein the barrel is grayscale.

[0159] Embodiment 24. The syringe of embodiment 1, wherein the first portion of the exterior surface of the barrel is textured to diffuse light refraction.

[0160] Embodiment 25. The syringe of embodiment 1, further comprising a generally flat wall extending laterally from the barrel, and a plurality of volumetric markings disposed on the generally flat wall.

[0161] Embodiment 26. The syringe of embodiment 25, wherein the generally flat wall has a textured surface to enhance adhesion of volumetric markings and stickers.

[0162] Embodiment 27. The syringe of embodiment 26, wherein the sticker has printed thereon at least one of descriptive information about the liquid medicine, a QR code for accessing the descriptive information about the liquid medicine, and pharmacy information.

[0163] Embodiment 28. A syringe of any of embodiments 25 to 27, wherein the substantially flat wall is textured using laser etching.

[0164] Embodiment 29. A syringe of any of embodiments 25 to 28, wherein the multiple volume markings aid in orienting the needle during manufacturing.

[0165] Embodiment 30. The syringe of any of embodiments 25 to 29, wherein at least a portion of the barrel has a textured outer surface to diffuse light refraction.

[0166] Embodiment 31. The syringe of embodiment 30, wherein the generally flat wall has substantially no texture other than the plurality of volumetric markings.

[0167] Embodiment 32. The syringe of embodiment 1, wherein at least a portion of the syringe has a textured surface to diffuse light refraction.

[0168] Embodiment 33. A syringe of any of embodiments 1 to 32, further comprising a laterally offset needle storage cavity integrally molded with the barrel, substantially coextensive longitudinally with the barrel, separated from the fluid chamber by a common wall, and a front-end attachment slidably engaging with the front of the barrel in a direction transverse to the longitudinal axis of the plunger, the front-end attachment having a forwardly protruding, rearwardly biased needle mounted therein, the needle being selectively retractable into the needle storage cavity after use.

[0169] Embodiment 34. A syringe of any one of embodiments 1 to 33, wherein the syringe does not have an electronic circuit.

[0170] Embodiment 35. A system for verifying the dosage accuracy of a medicinal liquid, the system comprising: a syringe having a barrel, a fluid chamber disposed within the barrel, a plunger slidably engaging the fluid chamber, and a needle, the syringe being configured to aspirate an actual dose of the medicinal liquid into the fluid chamber by moving the plunger rearward within the fluid chamber; and a first dataset including a predetermined volume ratio of the fluid chamber between a substantially full volume when the plunger is in a fully extended position relative to the barrel and a substantially empty volume when the plunger is in a fully inserted position relative to the barrel, the first dataset being configured to be stored in or accessed by a processor for use by a software application to determine the volume of the actual dose based on a digital image of at least a portion of the syringe after the actual dose has been aspirated into the fluid chamber and the position of the plunger relative to the barrel is between the fully extended position and the fully inserted position.

[0171] Embodiment 36. The system of embodiment 35, wherein the barrel is opaque.

[0172] Embodiment 37. The system of any of embodiments 35 to 36, wherein the barrel has no volumetric markings.

[0173] Embodiment 38. The system of embodiment 36, wherein at least a rear portion of the barrel has a first color, and when the plunger is in a fully inserted position, the rear portion of the plunger is disposed rearward of the barrel, and the rear portion of the plunger has a second color that contrasts with the first color.

[0174] Embodiment 39. The system of any of embodiments 35 to 38, further comprising a second dataset, the second dataset including predetermined dosage amounts based on at least one of pharmaceutical records, medical history, insurance reports, claims, biometrics, and prescriptions, and the second dataset is configured to be stored in or accessed by the processor for use in a software application to determine the accuracy of the actual dosage amount and compare it to the actual dosage volume.

[0175] Embodiment 40. The system of embodiment 39, wherein the biometric measurement is blood glucose level.

[0176] Embodiment 41. The system of any of embodiments 35 to 40, wherein a first portion of the syringe has a first color and a second portion of the syringe has a second color, and the first color and the second color are distinguishable from other portions of the syringe by the processor to determine the position of the plunger in the digital image.

[0177] Embodiment 42. The system of embodiment 41, wherein the first color is red.

[0178] Embodiment 43. The system of any of embodiments 41 to 42, wherein the first portion is positioned at or near the forward end of the barrel and the second portion is positioned at or near the rear end of the barrel.

[0179] Embodiment 44. The system of embodiment 43, wherein the barrel is sufficiently transparent so that the medicinal liquid in the fluid chamber can be seen through the barrel.

[0180] Embodiment 45. The system of embodiment 44, wherein the barrel is colored with a partially transparent gradient scale.

[0181] Embodiment 46. The system of embodiment 45, wherein the barrel is grayscale.

[0182] Embodiment 47. The system of any of embodiments 44 to 46, wherein the syringe further comprises a plurality of volumetric markings disposed on the outer surface of the barrel.

[0183] Embodiment 48. The system of embodiment 47, wherein the syringe comprises a first wall extending laterally from the barrel, a second wall extending laterally from the barrel and parallel to the first wall, a channel formed between the first wall and the second wall, a needle safety device configured to slide from a first rearward position to a second forward position and comprising an actuation handle at least partially disposed within the channel, and a needle tip shield connected to the actuation handle, wherein when the actuation handle is in the first rearward position, the needle tip shield surrounds the nose of the barrel, and when the actuation handle is in the second forward position, the needle tip shield surrounds the front end of the needle connected to the nose, and the second portion is a rear portion of the actuation handle.

[0184] Embodiment 49. The system of embodiment 43, further comprising a second dataset, the second dataset including a predetermined dosage based on at least one of pharmaceutical records, medical history, insurance reports, claims, biometrics, and prescriptions, the second dataset being configured to be stored in or accessed by the processor for use by a software application to compare with the actual dosage volume to determine accuracy of the actual dosage.

[0185] Embodiment 50. The system of embodiment 49, wherein the biometric measurement is blood glucose level.

[0186] Embodiment 51. The system of embodiment 49, wherein the first color is orange.

[0187] Embodiment 52. The system of embodiment 51, wherein the second color is orange.

[0188] Embodiment 53. The syringe of embodiment 50 or 52, wherein one of the first color and the second color is orange, and the other of the first color and the second color is blue.

[0189] Embodiment 54. The system of any of embodiments 49 to 51, wherein the first color and the second color are substantially identical.

[0190] Embodiment 55. The system of embodiment 43, wherein the first color is orange.

[0191] Embodiment 56. The system of embodiment 43 or 55, wherein the second color is orange.

[0192] Embodiment 57. The system of embodiment 43, wherein one of the first color and the second color is orange, and the other of the first color and the second color is blue.

[0193] Embodiment 58. The system of any of embodiments 43, or 55-56, wherein the first color and the second color are substantially identical.

[0194] Embodiment 59. A system of any of embodiments 35 to 47 or 55 to 58, comprising a needle storage cavity integrally molded with the barrel, substantially coextensive longitudinally with the barrel, separated from the fluid chamber by a common wall, and offset laterally; and a front-end attachment slidably engaging with the front of the barrel in a direction transverse to the longitudinal axis of the plunger, wherein a needle mounted therein projects forward, is biased rearward, and can be selectively stored in the needle storage cavity after use.

[0195] Embodiment 60. A method for verifying the accuracy of a dose of a medicinal liquid, the method comprising the steps of: aspirating an actual dose of the medicinal liquid into a fluid chamber of a barrel of a syringe, the syringe having a plunger slidably engaged with the barrel and a hypodermic needle; positioning a digital imaging device relative to the syringe, the digital imaging device comprising a camera, a processor, and a software application executed by the processor and configured to selectively view, capture, and store digital images of the syringe; capturing a digital image of the syringe; and processing the digital image to determine the volume of the actual dose of the medicinal liquid based on a predetermined volume ratio of the fluid chamber between a substantially full volume when the plunger is in a fully extended position relative to the barrel and a substantially empty volume when the plunger is in a fully inserted position and the position of the plunger relative to the barrel.

[0196] Embodiment 61. The method of embodiment 60, wherein the digital imaging device is a portable device.

[0197] Embodiment 62. The method of any of embodiments 60 to 61, wherein the digital imaging device is a mobile phone.

[0198] Embodiment 63. The method of any of embodiments 60 to 62, wherein the plunger has a plunger seal disposed at its front end, and the treatment is based on the position of the plunger seal within the fluid chamber.

[0199] Embodiment 64. The method of any of embodiments 60 to 63, wherein the barrel is not transparent.

[0200] Embodiment 65. The method of any of embodiments 60 to 62 or 64, wherein the plunger has a plunger cap disposed at its rear end, and the processing is based on the position of the plunger cap outside the fluid chamber.

[0201] Embodiment 66. The method of any of embodiments 60 to 62 or 64 to 65, wherein when the plunger is in the fully inserted position, the rear of the plunger is positioned at the rear of the barrel, and the processing is based on the position of the rear of the plunger.

[0202] Embodiment 67. The method of any of embodiments 60 to 66, further comprising the step of generating an alert to notify the user when a digital image of the syringe has been saved.

[0203] Embodiment 68. The method of embodiment 67, wherein the alert is at least one of an audible alert, a visual alert, and a tactile alert.

[0204] Embodiment 69. The method of any of embodiments 60 to 68, further comprising the steps of comparing the actual dose from the process with a predetermined dose of the medicinal solution, and generating an alert to notify the user if the actual dose is above or below the predetermined dose.

[0205] Embodiment 70. The method of embodiment 69, wherein the predetermined dosage is determined by cross-matching (1) at least one of the actual dosage, the name of the medication, or information identifying the patient receiving the actual dosage with (2) at least one of pharmaceutical records, medical history, insurance reports, claims, and prescriptions.

[0206] Embodiment 71. The method of any of embodiments 69 to 70, wherein the processing generates a first alert to notify the user if the actual dose exceeds a predetermined dose and generates a second alert to notify the user if the actual dose is below the predetermined dose, and the first alert is distinguishable from the second alert.

[0207] Embodiment 72. The method of any of embodiments 60 to 71, wherein the syringe has no external volumetric markings.

[0208] Embodiment 73. The method of any of embodiments 60 to 72, wherein at least a portion of the plunger is colored a different color than at least a portion of the barrel.

[0209] Embodiment 74. The method of any of embodiments 60 to 73, wherein the plunger has a first color and the barrel has a second color different from the first color.

[0210] Embodiment 75. The method of embodiment 74, wherein the first color and the second color are contrasting.

[0211] Embodiment 76. The method of any of embodiments 60 to 62, wherein the first portion of the syringe has a first RGB element that is distinguishable from other portions of the syringe, and the position of the plunger relative to the barrel is determined, at least in part, by distinguishing the first RGB element from other portions of the syringe.

[0212] Embodiment 77. The method of embodiment 76, wherein the barrel further comprises a plurality of volumetric markings, and the digital image comprises the plurality of volumetric markings.

[0213] Embodiment 78. The method of embodiment 77, wherein the multiple volume markings are not used in the process to determine the actual dose volume.

[0214] Embodiment 79. The method of embodiments 77 to 78, wherein the first RGB element includes a plurality of volumetric markings, and the plurality of markings are used in processing to determine the actual dose volume.

[0215] Embodiment 80. The method of embodiments 77 to 79, wherein the second portion of the syringe has a second RGB element.

[0216] Embodiment 81. The method of embodiments 77-80, wherein the first portion of the syringe is positioned at or near the front end of the barrel and the second portion of the syringe is positioned at or near the rear end of the barrel.

[0217] Embodiment 82. The method of embodiments 80 to 81, wherein the first RGB element is a first color and the second RGB element is a second color that is substantially different from the first color.

[0218] Embodiment 83. The method of embodiments 80 to 81, wherein the first RGB component is substantially identical to the second RGB component.

[0219] Embodiment 84. The method of embodiments 60 to 62, wherein the barrel is colored with a partially transparent gradient scale.

[0220] Embodiment 85. The method of embodiments 60 to 62, wherein the barrel is grayscale.

[0221] Embodiment 86. A method for injecting a verified dose of a medicinal fluid, the method comprising the steps of: providing a syringe having an opaque barrel, a fluid chamber disposed within the barrel, and a plunger slidably engaged with the barrel; providing a digital imaging device configured to selectively display, capture, and store digital images of the syringe; aspirating a dose of the medicinal fluid into the fluid chamber; positioning the digital imaging device relative to the syringe; capturing and storing digital images of the syringe and the medicinal fluid aspirated into the fluid chamber; and processing the digital images to determine the dose of the aspirated medicinal fluid.

[0222] Embodiment 87. The method of embodiment 86, wherein the imaging device is controlled using application software installed on the imaging device.

[0223] Embodiment 88. The method of embodiment 87, wherein the application software is configured to generate an alert to notify the user when a digital image of the syringe is saved.

[0224] Embodiment 89. The method of embodiment 88, wherein the alert is at least one of an audible alert, a visual alert, and a tactile alert.

[0225] Embodiment 90. The method of any of embodiments 87 to 89, wherein the application software is configured to notify the user if an incorrect fluid dose is aspirated into the syringe.

[0226] Embodiment 91. The method of embodiment 90, wherein the incorrect fluid dose is determined by matching the aspirated dose with at least one of pharmaceutical records, medical history, insurance reports, and claims.

[0227] Embodiment 92. The method of any of embodiments 86 to 91, wherein at least one of a comparator and a digital signal processor performs the processing.

[0228] Embodiment 93. The method of any of embodiments 86 to 92, wherein the processing is configured to determine the aspirated dose from a digital image of the position of the plunger handle relative to the barrel.

[0229] Embodiment 94. The method of any of embodiments 86 to 93, wherein the processing is configured to determine the aspirated dose from a digital image of the numerical markings on the barrel.

[0230] Embodiment 95. The method of any of embodiments 86 to 94, wherein the processing is configured to determine the aspirated dose from a plurality of digital images.

[0231] Embodiment 96. A system for verifying the accuracy of a dose of a medicinal liquid, the system comprising: a syringe having a barrel and a plunger slidably engaging a fluid chamber inside the barrel, the syringe configured to aspirate an actual dose of the medicinal liquid into the fluid chamber by moving the plunger rearward within the fluid chamber; an imaging device configured to selectively capture at least one digital image of a portion of the syringe; and a processor executing a software application for determining the volume of the actual dose of the medicinal liquid based on the at least one digital image of the portion of the syringe.

[0232] Embodiment 97. The system of embodiment 96, wherein the barrel is opaque and the processor is configured to determine the actual dose volume of the medicinal liquid based on a predetermined volume ratio of the fluid chamber between a substantially full volume when the plunger is in a fully extended position relative to the barrel and a substantially empty volume when the plunger is in a fully inserted position, and the position of the plunger relative to the barrel.

[0233] Embodiment 98. The system of embodiment 97, wherein at least a portion of the plunger is colored a different color than at least another portion of the barrel.

[0234] Embodiment 99. The system of any of embodiments 96 to 98, wherein the plunger has a first color and the barrel has a second color different from the first color.

[0235] Embodiment 100. The system of embodiment 99, wherein the first color and the second color are contrasting.

[0236] Embodiment 101. The system of embodiment 98, wherein part of the plunger is a plunger cap positioned at the rear end of the plunger, and the processor is configured to determine the actual dose based on the position of the plunger cap outside the fluid chamber.

[0237] Embodiment 102. The system of embodiment 98, wherein when the plunger is in the fully inserted position, a portion of the plunger is positioned rearward of the barrel, and the processor is configured to determine the actual dose based on the position of that portion of the plunger.

[0238] Embodiment 103. The system of any of embodiments 96 to 102, wherein the barrel has a set of volumetric markings along the length of the fluid chamber, and at least a portion of the barrel adjacent to the set of volumetric markings is sufficiently transparent so that the actual dose of the medicinal fluid can be seen through that portion of the barrel.

[0239] Embodiment 104. The system of embodiment 103, wherein the processor is configured to determine the actual dose volume based on the set of volume markings and the position of a seal disposed at the front end of the plunger within the fluid chamber.

[0240] Embodiment 105. The system of embodiment 103, wherein the processor is configured to determine the actual dose volume based on a set of volumetric markings and differences in coloration of the drug solution and the barrel.

[0241] Embodiment 106. The system of any of embodiments 96 to 105, wherein the processor is further configured to compare the actual dose volume of the medicinal fluid with the predetermined dose volume of the medicinal fluid and generate an alert to notify the user if the actual dose volume is above or below the predetermined dose volume.

[0242] Embodiment 107. The system of embodiment 106, wherein the predetermined dosage is determined by matching (1) at least one of the actual dosage, the name of the medication, or information identifying the patient receiving the actual dosage with (2) at least one of a pharmaceutical record, a medical history, an insurance report, a claim, and a prescription.

[0243] Embodiment 108. The system of any of embodiments 106 to 107, wherein the processor is configured to generate a first alert to notify the user when the actual dose volume exceeds the predetermined dose volume and to generate a second alert to notify the user when the actual dose volume is below the predetermined dose volume, and the first alert is distinguishable from the second alert.

[0244] Embodiment 109. A system of any of embodiments 96 to 102, wherein the syringe does not have external volume markings.

[0245] Embodiment 110. The system of any of embodiments 96 to 109, wherein the imaging device displays the actual dose volume numerically.

[0246] Embodiment 111. The system of any of embodiments 96 to 110, wherein the imaging device adds date and time data to at least one digital image.

[0247] Embodiment 112. The system of any of embodiments 96 to 111, wherein the imaging device is a handheld imaging device.

[0248] Embodiment 113. The system of embodiment 112, wherein the portable imaging device is a mobile phone.

[0249] Embodiment 114. The system of embodiment 112, wherein the mobile imaging device is a digital scanner.

[0250] Embodiment 115. The system of any of embodiments 96 to 114, wherein the imaging device is controlled using application software installed on the imaging device.

[0251] Embodiment 116. The system of embodiment 115, wherein the application software is configured to generate an alert to notify the user when at least one digital image of the syringe is saved.

[0252] Embodiment 117. The system of any of embodiments 96 to 116, further comprising a comparator configured to generate an alert to notify a user of an incorrect fluid dose drawn into the syringe.

[0253] Embodiment 118. The system of embodiment 117, wherein the alert is at least one of an audible alert, a visual alert, and a tactile alert.

[0254] Embodiment 119. A system of any of embodiments 96 to 118, wherein the syringe further comprises at least one needle safety feature configured to protect the user or a third party from an accidental needlestick injury.

[0255] Embodiment 120. The system of embodiment 119, wherein at least one needle safety feature includes a mechanism for selectively retracting the hypodermic needle after use.

[0256] Embodiment 121. A system of any of embodiments 96 to 120, wherein the syringe does not include numerical markings.

[0257] Embodiment 122. A system of any of embodiments 96 to 120, wherein the syringe includes empty and full plunger position indicators.

[0258] Embodiment 123. A system of any of embodiments 96 to 122, wherein the syringe has a known rated capacity.

[0259] Embodiment 124. A system of any of embodiments 96 to 123, wherein the imaging device is configured to determine the volumetric dose from a digital image of the position of the plunger handle relative to the barrel.

[0260] Embodiment 125. The system of embodiment 124, wherein the imaging device determines the volumetric dose using plunger position ratio calculations.

[0261] Embodiment 126. The system of embodiment 124, wherein the imaging device is configured for use with a syringe having an opaque barrel.

[0262] Embodiment 127. The system of embodiment 124, wherein the imaging device is configured for use with a syringe having a translucent barrel.

[0263] Embodiment 128. The system of embodiment 96, wherein the imaging device is configured to determine the inhaled dose from a digital image of the numerical markings on the barrel.

[0264] Embodiment 129. A system of any of embodiments 96 to 128, wherein the barrel has an outward wall integrally molded with the inward wall, the outward wall having volumetric markings and numerical markings disposed on a flat display surface longitudinally coextensive with the fluid chamber, whereby the complete volumetric markings and numerical markings are visible in relation to the plunger seal of the plunger.

[0265] Embodiment 130. A syringe of any of embodiments 96 to 129, wherein the portion of the syringe includes a portion of the plunger disposed within the fluid chamber of the barrel and at least a portion of the barrel.

[0266] Embodiment 131. A syringe of any of embodiments 96 to 129, wherein the portion of the syringe includes a plunger seal disposed around the plunger and engaging with the fluid chamber of the barrel, and at least a portion of the barrel.

[0267] Embodiment 132. A syringe of any of embodiments 96 to 129, wherein the portion of the syringe includes a portion of the plunger extending from the fluid chamber of the barrel and at least a portion of the barrel.

[0268] Embodiment 133. A system for injecting a verified dose of a medicinal liquid, the system comprising: means for injecting the medicinal liquid using a syringe having an opaque barrel, a fluid chamber disposed within the barrel, a plunger slidably engaging the barrel, and a hypodermic needle; means for positioning a digital imaging device relative to the syringe; means for aspirating a dose of the medicinal liquid into the fluid chamber using the plunger; means for displaying, selectively capturing, and storing at least one digital image of the syringe and the medicinal liquid aspirated into the fluid chamber using the digital imaging device; and means for determining a volumetric dose of the medicinal liquid by processing the digital image.

[0269] Embodiment 134. A method for injecting a verified dose of a medicinal fluid, the method comprising the steps of: providing a syringe having an opaque barrel, a fluid chamber disposed within the barrel, a plunger slidably engaged with the barrel, and a hypodermic needle; providing a digital imaging device configured to selectively display, capture, and store digital images of the syringe; aspirating a dose of the medicinal fluid into the fluid chamber; positioning the digital imaging device relative to the syringe; capturing and storing digital images of the syringe and the medicinal fluid aspirated into the fluid chamber; and processing the digital images to determine the dose of the aspirated medicinal fluid.

[0270] Embodiment 135. A non-transitory computer-readable storage medium having embedded therein a set of instructions that, when executed by a computer, cause the computer to perform operations for verifying a dose of medicinal fluid drawn into a syringe, the operations including: providing a syringe having an opaque barrel, a fluid chamber disposed within the barrel, a plunger slidably engaging with the barrel, and a hypodermic needle; providing a digital imaging device configured to selectively display, capture, and store a digital image of the syringe containing the dose of medicinal fluid drawn into the fluid chamber; aspirating the dose of medicinal fluid into the fluid chamber; positioning the digital imaging device relative to the syringe; capturing and storing digital images of the syringe and the medicinal fluid drawn into the fluid chamber; and processing the digital image to determine the dose of the aspirated medicinal fluid.

[0271] The present disclosure may, however, be embodied in many different forms and should not be construed as limited to any specific structure or function presented throughout this disclosure. Rather, these aspects are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the disclosure to those skilled in the art. Based on the teachings herein, those skilled in the art will understand that the scope of the present disclosure is intended to encompass any aspect of the disclosure described herein, whether implemented independently of or in combination with other aspects of the disclosure. For example, an apparatus may be implemented or a method may be practiced using any number of the aspects described herein. Furthermore, the scope of the present disclosure is intended to encompass such apparatus or methods that are implemented using other structure, functions, or structures and functions in addition to or other than the various aspects of the disclosure described herein.

[0272] It should be understood that any aspect of the disclosure described herein may be embodied by one or more elements of a claim. The word "exemplary" is used herein to mean "serving as an example, instance, or illustration." Any aspect described herein as "exemplary" is not necessarily to be construed as preferred or advantageous over other aspects. While particular aspects have been described herein, many variations and modifications of these aspects are within the scope of the disclosure. While certain benefits and advantages of the preferred aspects have been mentioned, the scope of the disclosure is not intended to be limited to any particular advantage, application, or objective. The detailed description and drawings are merely illustrative rather than limiting, the scope of the invention being defined by the appended claims and their equivalents.

[0273] Terms and phrases used herein, and variations thereof, unless expressly stated otherwise, should be construed as open-ended and not limiting. For example, the term "including" should be construed as meaning "including, without limitation," and the term "example" is used to indicate examples of the subject matter, not as an exhaustive or limiting list. The term "a" or "an" should be construed as meaning "at least one" or "one or more." Furthermore, adjectives such as "conventional," "traditional," "normal," "standard," and "known" should not be construed to limit the subject matter to a particular point in time or to items available at that time, but should be construed to encompass conventional, traditional, usual, and standard technology that may be available or known at any time now or in the future. Similarly, when this specification refers to technology that would be apparent or known to those of ordinary skill in the art, such technology includes technology that will be apparent or known to those of ordinary skill in the art now or at any time in the future. The occasional presence of broad words or phrases such as "one or more," "at least," "but not limited to," or other similar phrases should not be interpreted as implying that a narrower case would be intended or required in the absence of such broader phrase. The use of the term "component" does not imply that all components or functionality described or claimed as a component are configured in a common package. Indeed, some or all of the various components of a component, whether control logic or other components, may be combined in a single package, maintained separately, or even distributed across multiple groups or packages or locations.

[0274] Other variations and modifications of the present disclosure will similarly become apparent to those skilled in the art upon reading this specification in light of the accompanying drawings, and it is intended that the scope of the disclosure disclosed herein be limited only by the broadest interpretation of the appended claims that legally entitled.

[0275] References herein to the front or forward direction, etc., generally refer to the direction toward a patient when the syringe or other medical device herein is in use, or the direction from the thumb cap or thumb flange of the plunger toward the nose of the barrel. References herein to "rear," "back," "backward," "dorsal," etc., refer to directions substantially opposite to "front," "forward," etc.

[0276] Any component, feature, or step indicated herein as preferred or preferred may be used alone or in any combination with other preferred or preferred components, features, or steps. Any component, feature, or step described herein with respect to any embodiment may be used in any other embodiment even if not specifically described in such embodiment, unless specifically stated to be excluded from use in such embodiment.

Claims

1. 1. A syringe for verifying the volume of a liquid medicine drawn into the syringe, comprising: Barrel and a fluid chamber disposed inside the barrel and configured to receive a medical solution in the syringe; a plunger slidably engaging the fluid chamber; It is equipped with a first portion of the syringe including a first component; a second portion of the syringe including a second component; The first and second components are distinguishable from other portions of the syringe by a processor in a digital image of at least a portion of the syringe to determine a position of the plunger relative to the barrel indicative of a volume of the medicinal liquid drawn into the syringe.

2. 10. The syringe of claim 1, wherein the barrel, the plunger, or a combination thereof is free of volumetric markings.

3. 10. The syringe of claim 1, wherein the first component and the second component are RGB components.

4. 4. The syringe of claim 3, wherein the first and second components are in contrast to other portions of the syringe.

5. 10. The syringe of claim 1, wherein the first component is a first color and the second component is a second color.

6. 6. The syringe of claim 5, wherein the first color contrasts with the second color.

7. 6. The syringe of claim 5, wherein the first color and the second color contrast with other portions of the syringe.

8. 6. The syringe of claim 5, wherein the first color is different from the second color.

9. 9. The syringe of claim 8, wherein one of the first color and the second color is orange.

10. 10. The syringe of claim 9, wherein the other of the first color and the second color is blue.

11. 10. The syringe of claim 1, wherein the barrel is opaque.

12. 2. The syringe of claim 1, wherein the first portion includes a front end of the barrel and the second portion is disposed at a rear end of the barrel.

13. 10. The syringe of claim 1, wherein the barrel is colored with a partially transparent graduated scale.

14. 14. The syringe of claim 13, wherein the barrel is grayscale.

15. 10. The syringe of claim 1, wherein at least a portion of the syringe has a textured surface for diffusing light refraction.

16. In a system for verifying the accuracy of drug solution dosage, a syringe having a barrel and a plunger slidably engaging a fluid chamber within the barrel, the syringe configured to draw an actual dose of the medical fluid into the fluid chamber by moving the plunger rearwardly within the fluid chamber; an imaging device configured to selectively capture at least one digital image of a portion of the syringe; and a processor executing a software application for determining an actual dose volume of the medical solution based on the at least one digital image of the portion of the syringe. A system comprising:

17. 17. The system of claim 16, wherein the processor is configured to determine an actual dose volume of the medicinal fluid based on a predetermined volume ratio of the fluid chamber between a substantially full volume when the plunger is in a fully extended position relative to the barrel and a substantially empty volume when the plunger is in a fully inserted position relative to the barrel and a position of the plunger relative to the barrel.

18. 17. The system of claim 16, wherein the portion of the syringe includes at least a portion of the barrel and at least one of: (1) a portion of a plunger disposed within the fluid chamber of the barrel; (2) a plunger seal disposed around the plunger and engaging the fluid chamber of the barrel; and (3) a portion of the plunger extending from the fluid chamber of the barrel and at least a portion of the barrel; and wherein the processor is configured to determine the actual dose volume based on a position of the plunger relative to the barrel.

19. 17. The system of claim 16, wherein the processor is configured to determine the actual dose volume based on a difference in coloration between the medication and the barrel.

20. 17. The system of claim 16, wherein the processor is configured to compare an actual dose volume of the medical fluid to a predetermined dose volume of the medical fluid and generate an alert to notify a user if the actual dose volume is above, below, or equal to the predetermined dose volume.

21. 21. The system of claim 20, wherein the predetermined dosage is determined by matching (1) at least one of the actual dosage, the name of the medicinal solution, or information identifying the patient receiving the actual dosage with (2) at least one of pharmaceutical records, medical history, insurance reports, claims, and prescriptions.

22. The system of claim 16 , wherein the imaging device is controlled using application software installed on the imaging device.

23. 1. A method for verifying the dosage of a drug solution, comprising: providing a syringe having an opaque barrel, a fluid chamber disposed within the barrel, and a plunger slidably engaging the barrel; providing a digital imaging device configured to selectively display, capture, and store digital images of the syringe; aspirating the dose of fluid into the fluid chamber; positioning the digital imaging device relative to the syringe; capturing a digital image of the syringe and the fluid drawn into the fluid chamber; processing the digital image to determine the dose of the aspirated medical fluid; A method comprising:

24. 24. The method of claim 23, wherein the imaging device is controlled using application software installed on the imaging device.

25. 25. The method of claim 24, wherein the application software is configured to generate an alert to notify a user when a digital image of the syringe has been saved.

26. 26. The method of claim 25, wherein the alert is at least one of an audible alert, a visual alert, and a tactile alert.

27. 25. The method of claim 24, wherein the application software is configured to notify a user if an incorrect fluid dose is drawn into the syringe.

28. 28. The method of claim 27, wherein the incorrect fluid dose is determined by checking the aspirated dose against at least one of a pharmaceutical record, a medical history, an insurance report, and a claim.

29. 24. The method of claim 23, wherein the processing is configured to determine the drawn dose from a digital image of the position of a plunger handle relative to the barrel.

30. 24. The method of claim 23, wherein the processing is configured to determine the aspirated dose from a plurality of digital images.

Images