Universal dose verification system and method for medical injector

Abstract

Systems and methods of a dose verification system are disclosed that can be used by a medical worker or an individual who administers an injection by himself to create a digital record to verify the dose of a pharmaceutical fluid drawn into a syringe prior to the injection. The dose verification system comprises a medical syringe and an imaging device configured to view and selectively capture, process, store and transmit digital images of the syringe from which a volumetric dose of a pharmaceutical fluid drawn into a fluid chamber of the syringe can be determined and / or verified prior to injection.

Description

Technical Field

[0001] The present application relates to a system and method for quickly and reliably verifying and providing a visual and digital history of the dose of medicinal fluid drawn into a medical syringe or other patient fluid delivery device before the medicinal fluid is administered to a patient. Background Art

[0002] The Joint Commission (a US-based non-profit organization that accredits over 22,000 US health care organizations and plans) has identified medication administration as one of the top ten adverse medical events. An "adverse medical event" is an unexpected occurrence that results in death, permanent injury, serious temporary injury, or intervention for a patient. Identifying and reducing the ways in which medical errors occur is a major concern in the healthcare and insurance industries. Medical errors are preventable side effects of medical care, whether or not they are obvious or harmful to the patient. Medication errors are a common cause of medical errors and can include administering the wrong medication to a patient, or administering the wrong dose of a correct medication.

[0003] Dosage errors may result from errors in calculating the recommended dose based on factors such as the patient's age, weight, and blood sugar level, or from errors in reading the aspirated dose on the volume scale of a medical syringe. Because the desired dose of a medicinal fluid such as insulin may depend on factors such as the patient's real-time blood sugar level before injection, it is not always feasible to use factory-preloaded automatic syringes to avoid dosage errors. For smaller volume syringes, such as 1.0 mL and 0.5 mL, the curvature of the syringe barrel associated with the small diameter of a conventional cylindrical syringe barrel makes the volume scale and the associated numerical markings difficult to print and difficult to read. In some cases, the volume scale markings and the associated numerical markings may surround the syringe barrel, making it impossible for the user to accurately see and read them at the same time. In this case, accurately reading the aspirated dose may be difficult or impossible for a medical professional, thereby further increasing the possibility of dosage errors when administering an injection. The possibility of this error is further aggravated by patients or non-professional caregivers who aspirate their own dose for injection or other administration.

[0004] Various protocols have been developed in an effort to reduce this medical error, but it remains a major concern. In many healthcare settings, healthcare providers must have another person visually verify the medication and the dose being aspirated before administering an injection to a patient. This requirement can place an additional burden on clinic or hospital staffing, especially during periods of staffing shortages, such as those experienced during the pandemic. Summary of the Invention

[0005] It is believed that the universal dose verification system and method as disclosed herein reduces the possibility of medical errors caused by drawing an incorrect dose of medicinal fluid into a medical syringe or other needle-based patient fluid delivery device prior to injection or administration. Use of the present disclosure can also avoid the need for one person to draw a dose while another person is present to verify the drawn dose. The present disclosure can be adapted for use with medical syringes of various sizes, shapes, and cross-sectional configurations, and with syringes having a known volume capacity but having barrel walls that are opaque or lack clearly readable volume graduations or numerical markings.

[0006] According to a preferred embodiment, a system and method selectively captures a digital image of a syringe containing a single dose of medicinal fluid before administering an injection, and performs at least one process to determine the volume of the medicinal fluid in the syringe based on the digital image. As used herein, a single dose generally refers to a dose of medicinal fluid drawn into a syringe shortly before injection, but may also include pre-filled syringes for which it is desirable to accurately verify the volume of the pre-filled medicinal fluid. In some embodiments, the process of determining the volume of the medicinal fluid includes comparing the position of the plunger of the syringe with the volume of the drawn medicinal fluid with a known volume associated with a known position of the plunger. In some embodiments, the known position of the plunger includes a fully extended position relative to the syringe (substantially a full volume position) and a fully inserted position relative to the syringe (substantially an empty volume position). In other embodiments, the process of determining the volume of the medicinal fluid includes comparing the position of the plunger with a volume marking or volume scale on the syringe. As further described herein, various other processes may also be used in other embodiments.

[0007] According to another preferred embodiment, a digital image of a syringe containing a single dose of a medicinal fluid can be stored prior to administering an injection and can be recalled or accessed at any future time for review by a physician or regulatory agency, or for subsequent re-verification (or confirmation of its original verification) of the dose drawn for a particular injection, if such verification is required. In further embodiments, the digital image of a syringe containing a single dose of a medicinal fluid can be linked to a digital processor that can be used to generate reports, upload the image data to a database, and communicate online with other medical providers, records, or networks.

[0008] In other embodiments, 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 of a medicinal fluid to establish an accurate and reliable history of the dose drawn into the syringe or pre-filled syringe dose prior to administration of the medicinal fluid by injection or infusion. In one embodiment, the dose verification system can be programmed using application software and associated programming that can be downloaded and installed on a cellular phone equipped with at least one camera lens to assess image clarity and determine when the image is sufficiently focused to provide a reliable digital record of the confirmed dose.

[0009] In other embodiments, the dose verification system and method can be further implemented by providing appropriate lenses, software and auxiliary components and circuitry to focus, capture, store, index, retrieve, cross-check, analyze and / or transmit digital data and images to provide an accurate historical record of the volume of medicinal fluid in a medical syringe prior to injection or infusion, in addition to the date and time the dose was withdrawn. If desired, multiple digital images of the same medical syringe containing the same dose can be captured and iteratively analyzed to determine whether a statistically valid and reliable record (within an appropriate standard deviation, confidence level, or other error checking protocol) has been achieved to verify the dose in the syringe. Optional data analysis features can include cross-matching with medication records, which include typical doses for a given time of day, medical records, insurance reports, and bills.

[0010] In one embodiment, the volume of the aspirated dose of the medicinal fluid is determined by directly imaging the fluid level and / or a portion of the plunger, which direct imaging is associated with a clearly visible volume scale printed directly on the syringe with the aspirated dose, which volume scale preferably has numerical markings or volume markings.

[0011] In another embodiment, the level of a drawn dose of a medicinal fluid disposed within the fluid chamber of a syringe barrel of known volumetric capacity, having opaque or otherwise non-transparent barrel walls or lacking clearly visible volumetric markings and numerical indicia, can be determined by imaging the position of the plunger handle relative to the barrel and the dose in the fluid chamber, and then calculating (e.g., by ratios and proportions) the apparent volume of the drawn dose based on known data related to the plunger position and / or syringe configuration when the fluid chamber is full or the plunger position when the fluid chamber is empty. In such an embodiment, only a single digital image of the syringe with the drawn dose in the fluid chamber is required. In yet another embodiment, the level of a drawn dose can be similarly determined by taking at least two images of the syringe: (1) one imaging the position of the plunger handle relative to the barrel with the dose in the fluid chamber, and (2) a second imaging the position of the plunger handle relative to the barrel before the dose is drawn or after the dose is injected. In some embodiments, only a portion of the plunger handle may be visible to the imaging device, which may be the portion within the barrel of the syringe or the portion extending from the barrel of the syringe. Furthermore, in other embodiments, only the plunger seal of the plunger handle may be visible to the imaging device to verify dosage.

[0012] In another embodiment, an indicator marking can be provided on an outwardly facing surface of the syringe barrel for defining the position of the plunger handle and plunger seal relative to the syringe barrel when (i) the plunger is fully inserted into the syringe barrel (zero dose or empty), and when (ii) a maximum dose (the nominal volume capacity of the syringe) has been drawn into the fluid chamber inside the syringe barrel (and the plunger has been fully extended out of the syringe barrel). In such an embodiment, the digital imaging device of the dose verification system is configured to image the indicator marking for determining the position of the plunger handle and / or plunger seal relative to the syringe barrel and the associated dose of medicinal fluid drawn into the syringe prior to injection.

[0013] In another embodiment, for a syringe where the nominal volume of the syringe (e.g., 1 mL, 0.5 mL, etc.) is known but the fluid level of the dose drawn into the fluid chamber of the syringe is not visible due to other factors, the dose verification system and method can be configured to determine the drawn dose in ratio and proportion by imaging (and measuring) the position of the plunger relative to the syringe for the drawn dose and comparing it to the position of the plunger when the fluid chamber is empty or full.

[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) display surface. The flat display surface enables the camera, scanner, or other digital imaging device (e.g., a cell phone with camera functionality) to clearly view and capture an image of the dose drawn into the syringe and the position of the plunger relative to one or more other components of the syringe. In yet another preferred embodiment, a volumetric dose scale or digital volume markings are provided on the flat (or substantially flat) display surface of the specially configured syringe. In this embodiment, the camera, scanner, or other digital imaging device can clearly view and capture an image of the entire volumetric dose scale of the syringe, the position of the plunger relative to one or more other components of the syringe, and the medicinal fluid drawn into the syringe prior to administering the injection or infusion.

[0015] In another embodiment, the level of medicinal fluid drawn into the fluid chamber of the syringe barrel can be determined from a single viewing location through a single wall of the barrel and from separate markings and / or numerical values ​​on the syringe indicating the incremental (volume) levels inside the syringe barrel. The markings and / or numerical values ​​associated with the volume scale can be printed (e.g., pad printed) or molded onto the outer surface of the syringe.

[0016] In another embodiment, the dose verification system is optionally linked to a database of acceptable doses for a particular medicinal fluid and the patient's profile, and a digital image or scan of the syringe with the withdrawn dose is stored in the dose verification system. In another embodiment, such a digital image can also be uploaded, preferably automatically, to a digitized patient record that is accessible with appropriate security measures for various categories of identified user groups. Such user groups can include, for example, doctors, nurses, hospital administrators, pharmacy administrators, caregivers, and risk and insurance administrators. The digitized patient record, including the uploaded digital image, can also be selectively accessed by the patient via an application loaded on a mobile device (e.g., a phone or tablet) or through a healthcare provider website.

[0017] In some embodiments, the dose verification systems and methods can be used with any type of syringe or medicinal fluid injection device, without requiring any dedicated syringe or injection device.

[0018] In further embodiments, the dose verification systems and methods can be used with any of the various embodiments of a syringe for digitally verifying a volume of a medicinal fluid described herein, which is a specialized syringe and injection device having various features that facilitate digital dose verification as described herein. For example, in one embodiment, a syringe for digital verification is used with the dose verification systems and methods described herein, the syringe comprising a needle retraction mechanism. The needle retraction mechanism can include a laterally offset needle retraction cavity that extends substantially within the same range as the length of the fluid chamber of the syringe barrel. After injection, the needle can be selectively retracted by sliding movement of a component of the syringe to shift the needle from being substantially aligned with the barrel to being substantially aligned with the needle retraction cavity, allowing a spring to push the needle rearwardly into the needle retraction cavity so that the sharp tip of the needle is protected within the needle retraction cavity or by another component of the syringe. Preferably, the needle retraction cavity is substantially the same length as the barrel to allow for the use of longer needles, which broadens 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 can include, for example, performing a spinal tap, administering an epidural, aspirating a cyst, etc., as well as for administering intradermal, subcutaneous, or intramuscular injections.

[0019] In another embodiment, a syringe for digital verification for use with the dose verification systems and methods herein includes a sliding needle safety device that can be selectively positioned to allow the sharp front end of the syringe's needle to be exposed for injection and then covered after the injection is complete. The needle safety device according to one embodiment may include an activation handle and a needle tip shield connected to the activation handle. The activation handle is preferably substantially parallel to the syringe's barrel and can slide forward to position the needle tip shield over the front end of the needle when the injection is complete. The needle tip shield is preferably configured to extend circumferentially around the needle and to be coaxially aligned with the needle. In one embodiment, the needle tip shield is connected to the activation handle or is integrally molded with the activation handle. The needle safety device according to these embodiments eliminates the need for a needle retraction mechanism and a needle retraction cavity, and does not require lateral sliding movement of the syringe relative to the needle to protect the user from accidental needle sticks. After using this embodiment of the syringe, the needle tip shield is selectively advanced to protect the user from the forwardly extending needle tip by applying manual pressure to a touch surface of the activation handle located behind the needle and needle tip shield. In one embodiment, the activation handle can slidably engage the syringe barrel and can slide 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 enclosed and protected from accidental needle sticks by the needle tip shield.

[0020] In yet another embodiment, a syringe for digital verification for use with the dose verification systems and methods herein includes at least one laterally extending wall that extends at least partially longitudinally along or adjacent to the barrel of the syringe and includes a substantially flat, outwardly facing surface. The outer surface can serve as a display surface to which markings such as dose graduations or digital volume information can be applied using a conventional pad printing process (sometimes referred to as "gravure printing") for applying volumetric dose markings or other markings to a substantially flat display surface of a syringe, or by embossing or molding. In one embodiment, the laterally extending wall extends laterally from the barrel to both sides of the barrel. In another embodiment, the laterally extending wall extends laterally from the barrel to only one side. In another embodiment, the laterally extending wall is integrally molded with the barrel. In yet another embodiment, the laterally extending wall or a portion thereof forms part of the needle retraction cavity.

[0021] In another embodiment, a syringe for digital verification for use with the dose verification systems and methods of the present invention includes two laterally extending walls, each having a substantially flat outwardly facing surface, and each laterally extending wall extending at least partially along the longitudinal direction of the syringe's barrel or extending adjacent to the longitudinal direction of the syringe's barrel. In one embodiment, the two laterally extending walls are oppositely facing, laterally spaced apart from each other, and parallel. In one embodiment, the two outer surfaces can have the same markings or can have different markings. Embodiments with two outer surfaces can be pad printed without having to rotate the syringe, even when printing on 1 mL, 0.5 mL, or smaller syringes. Having a substantially flat outer display surface also facilitates applying markings to the syringe by other processes (e.g., embossing and injection molding).

[0022] In another embodiment having two laterally extending walls, the laterally extending wall or a portion thereof forms a portion of the needle retraction chamber. In one embodiment, the first laterally extending wall forms an upper wall of the needle retraction chamber, and the second laterally extending wall forms a lower wall of the needle retraction chamber. In another embodiment, a third wall connects the outer ends of the upper and lower walls to form a portion of the needle retraction chamber, and the fourth inner wall comprises a portion of a side wall of the syringe barrel. The needle retraction chamber may have a non-circular cross-section.

[0023] In another embodiment having two laterally extending walls, the two laterally extending walls form a recess configured to receive an activation handle of the needle safety device to allow the activation handle to slide forward relative to the laterally extending walls. In one embodiment, an inner surface on one or both walls includes a stop surface that prevents the activation handle from subsequently moving backward once the activation handle has been slid forward, thereby protecting the user from subsequent accidental exposure of the needle tip and associated needle stick injuries. In other embodiments, suitable tracks, ramps, stop shoulders, and detents, or other similar effective structures, are provided as part of the activation handle and / or one or both of the laterally extending walls and / or the syringe, so that the activation handle can be smoothly advanced without significant interference when needed, and will not accidentally retract or slide backward after moving forward to re-expose the sharp needle tip.

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

[0025] In another embodiment, a dose verification system and method are adapted for use with a medical syringe having at least one flat, or substantially flat, outwardly facing, indicia display surface overlying a fluid chamber within the interior of the syringe barrel. Such a display surface may comprise a portion of a sidewall of the fluid chamber of the syringe that is integrally molded such that fluid within the fluid chamber is visible through a single wall, rather than through multiple layers of material or wall layers. In a syringe in which the fluid level of an aspirated dose is clearly visible through the single wall of the fluid chamber relative to a volume scale, an imaging device may be configured to capture and record the aspirated dose in relation to a corresponding value on the volume scale, wherein the volume scale is printed on or molded into the display surface and overlies or is adjacent to at least a portion of the fluid chamber.

[0026] In some aspects, the systems and methods described herein relate to a device for injecting a verified dose of a medicinal fluid, the device comprising: a syringe having an opaque barrel, a plunger handle, and a hypodermic needle, the plunger handle having a plunger seal that slidably engages a fluid chamber within the barrel; and an imaging device configured to view and selectively capture, process, store, and transmit at least one digital image of the syringe, from which a volumetric dose of the medicinal fluid 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 medicinal fluid, the system comprising: a device for injecting the medicinal fluid using a syringe, the syringe having an opaque barrel, a fluid chamber disposed within the barrel, a plunger slidably engaged with the barrel, and a hypodermic needle; a device for positioning a digital imaging device relative to the syringe; a device for drawing a dose of the medicinal fluid into the fluid chamber using the plunger; a device for viewing and selectively capturing and storing at least one digital image of the syringe and the medicinal fluid drawn into the fluid chamber using the digital imaging device; and a device for determining a volumetric dose of the medicinal 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 a set of instructions embedded therein that, when implemented by one or more processors of a computer, cause the computer to implement operations for verifying a dose of a medicinal fluid drawn into a syringe, the operations comprising: 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 view, capture, and store a digital image of the syringe containing the drawn dose of medicinal fluid; drawing a dose of medicinal fluid into the fluid chamber; positioning the digital imaging device relative to the syringe; capturing and storing a digital image of the syringe and the medicinal fluid drawn into the fluid chamber; and processing the digital image to determine the drawn dose of the medicinal fluid.

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

[0030] In some aspects, the systems and methods described herein relate to a system for verifying the accuracy of a dose of a medicinal fluid, the system comprising: a syringe comprising a syringe, a fluid chamber disposed within the syringe, a plunger slidably engaged with the fluid chamber, and a needle, the syringe configured to draw an actual dose of the medicinal fluid into the fluid chamber by rearward movement of the plunger in the fluid chamber; and a first data set comprising a pre-determined volumetric proportion of the fluid chamber, the pre-determined volumetric proportion being a ratio between a substantially full volume when the plunger is in a fully extended position relative to the syringe and a substantially empty volume when the plunger is in a fully inserted position relative to the syringe, the first data set being configured to be saved to or accessed by a processor for use in a software application to determine the volume of the actual dose based on a digital image of the syringe after the actual dose is drawn into the fluid chamber and the position of the plunger relative to the syringe 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 comprising: a camera configured to selectively capture at least one digital image of a syringe and an actual dose of medicinal fluid in a fluid chamber, wherein the syringe has a syringe and a plunger slidably engaged with the fluid chamber within the syringe; and a processor implementing a software application configured to determine a volume of the actual dose of the medicinal fluid based on the at least one digital image of the syringe and provide at least one piece of information regarding the volume of the actual dose to a user.

[0032] In some aspects, the systems and methods described herein relate to a system for verifying the accuracy of a dose of a medicinal fluid, the system comprising: a syringe having a barrel, a plunger slidably engaged with a fluid chamber within the barrel, and a hypodermic needle, the syringe configured to draw an actual dose of the medicinal fluid into the fluid chamber by rearward movement of the plunger in the fluid chamber; and an imaging device configured to selectively capture at least one digital image of the syringe, and a processor implementing a software application to determine the volume of the actual dose of the medicinal fluid based on the at least one digital image of the syringe.

[0033] In one embodiment, a method for verifying a dose of a medicinal fluid drawn into a medical syringe comprises: (1) providing a medical syringe having a barrel, a fluid chamber disposed within the barrel, a plunger slidably engaged with an inner wall of the barrel, and a hypodermic needle extending forward from the barrel; (2) providing a digital imaging device, and most preferably, a dose verification system, configured to capture a digital image of a dose of medicinal fluid drawn into the fluid chamber of the medical syringe; (3) drawing a dose of medicinal fluid into the fluid chamber of the medical syringe; (4) selectively positioning the digital imaging device relative to the medical syringe containing the drawn dose of medicinal fluid; (5) capturing a digital image of the medical syringe; and (6) processing the digital image to determine the actual volume of the drawn dose. Although other digital imaging devices may be used in methods according to embodiments herein, most preferably, a dose verification system according to embodiments herein is used with the methods herein.

[0034] According to another embodiment, a method for verifying a dose of a medicinal fluid drawn into a medical syringe further comprises: (7) storing a digital image to create a digital record of the drawn dose of the medicinal fluid. According to another embodiment, a method for verifying a dose of a medicinal fluid drawn into a medical syringe further comprises one or more of the following steps: (8) recalling or retrieving one or more digital images from memory to visually re-verify or confirm the actual dose as previously determined by the dose verification system and method 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 dose verification system and method described herein to an external device, database, or person (e.g., a user's physician); (10) transmitting one or more digital images to an external device, database, or person (e.g., a user's physician); and / or (11) generating an alert when the actual dose determined by the dose verification system and method described herein is inaccurate based on a comparison with a set of linked or stored data, which set of linked or stored data may include prescriptions, medical records, insurance information, medical device readings (e.g., blood glucose levels determined by a glucose monitor).

[0035] According to some embodiments, processing the digital image to determine the actual volumetric dose aspirated includes determining the position of the plunger relative to another component of the syringe (e.g., the barrel) (in the case of a syringe with a dose of medicinal fluid) and utilizing a predetermined volume ratio of the fluid chamber, the predetermined volume ratio being the ratio of a substantially full volume when the plunger is in a fully extended position relative to the barrel to a substantially empty volume when the plunger is in a fully inserted position relative to the barrel. This embodiment is particularly useful if the syringe does not include volume markings and / or the fluid chamber / barrel is opaque.

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

[0037] Use of the dose verification systems and methods herein can reduce the likelihood of medical errors due to drawing an incorrect dose into a medical syringe prior to injection and will provide an accurate historical record in the form of a digital image of the dose drawn into the fluid chamber of the medical syringe and other stored data regarding the dose.

[0038] Other benefits and advantages of the medical device of the present invention will also become more apparent to those of ordinary skill in the art after reading this disclosure in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0039] The systems and methods of the present disclosure will be further described and explained with reference to the following drawings, in which:

[0040] Figure 1 is a top perspective view of an embodiment of components of a dose verification system showing a cellular telephone with digital imaging capabilities positioned in a use position above a medical syringe according to embodiments herein, wherein the medical syringe has a syringe with a flat, upwardly facing outer wall, a dose of medicinal fluid drawn through the syringe into a tubular fluid chamber disposed within the syringe being visible through the upwardly facing outer wall, the dose of medicinal fluid being associated with volumetric graduations and associated numerical indicia disposed on the flat, upwardly facing surface of the upwardly facing outer wall;

[0041] Figure 2 yes Figure 1 an enlarged top plan view of a cell phone of a dose verification system for a syringe, wherein the digital image shows a portion of a volume scale and associated numerical indicia disposed on an upwardly facing surface of an upwardly facing outer wall of a syringe barrel and overlying a portion of a fluid chamber through which a withdrawn dose of medicinal fluid is clearly visible and indicated by shading in the drawing;

[0042] Figure 3is a top perspective view of another embodiment of a component of a dose verification system showing an adjustably mounted digital imaging device disposed in a use position above a medical syringe according to embodiments herein, wherein the medical syringe has a barrel with a flat, upwardly facing outer wall forming an upwardly facing indicia display surface carrying volumetric graduations and associated numerical indicia through which a dose of medicinal fluid drawn into a tubular fluid chamber of the syringe barrel is visible.

[0043] Figure 4 yes Figure 3 an enlarged top plan view of a digital display portion of a mounted digital imaging device of a dose verification system, wherein the digital image shows a portion of a volume scale and associated numerical indicia disposed on an upwardly facing surface of a syringe barrel and overlying a fluid chamber containing a withdrawn dose of medicinal fluid (shaded in the figure);

[0044] Figure 5 yes Figure 1 and Figure 3 a cross-sectional plan view of a medical syringe with the plunger partially inserted into the barrel but without any aspirated dose of medicinal fluid to better illustrate the fluid chamber within the barrel;

[0045] Figure 6 is a longitudinal side view of a conventional medical syringe having an elongated tubular barrel with a cylindrical fluid chamber of known maximum rated volume capacity (e.g., 0.5 mL; 1.0 mL, 2.0 mL, but for simplicity of illustration, as explained in the following description, without volume graduations and associated numerical markings), wherein the conventional medical syringe has a needle and a plunger, the needle extending forwardly from the barrel, and the plunger having a plunger seal fully inserted into the barrel;

[0046] Figure 7 yes Figure 6 A longitudinal side view of a plunger of a conventional medical syringe;

[0047] Figure 8 is a side view of an embodiment of components of a dose verification system, showing the Figure 6 a portable imaging device with a conventional medical syringe disposed in a use position, wherein the plunger is partially withdrawn after a dose of medicinal fluid is drawn into the fluid chamber and the field of view of the portable imaging device is adjusted to include the full functional length of the fluid column within the syringe;

[0048] Figure 9 Yes Figure 8another view of the same embodiment as in, except that the syringe is opaque and the portable imaging device is repositioned to adjust the field of view to include an area through which the plunger handle extends rearwardly from the syringe after a dose of medicinal fluid is drawn into the syringe;

[0049] Figure 10 is a schematic diagram of an embodiment of a dose verification system with an imaging device disposed in a position of use above a medical syringe and also illustrating exemplary auxiliary elements of the system disposed in a configuration for carrying out the functions and methods of operation;

[0050] Figure 11 is a perspective view from the front and top of a medical syringe with a needle retraction mechanism according to an embodiment of the present invention;

[0051] Figure 12 yes Figure 11 A front top perspective view of an embodiment of wherein the needle cover is removed;

[0052] Figure 13 yes Figure 11 An exploded perspective view from the front upper side of an embodiment of the present invention;

[0053] Figure 14 yes Figure 12 A side view from the right side of an embodiment of the invention;

[0054] Figure 15 It is along Figure 14 A cross-sectional view taken along line 305-305;

[0055] Figure 16 yes Figure 13 A partially broken away, detailed perspective view of the front attachment of an embodiment of Figure 13 The front portion of the syringe of the embodiment is shown in juxtaposition;

[0056] Figure 17 yes Figure 13 A rear-superior perspective view of the front attachment;

[0057] Figure 18 yes Figure 14 a right side perspective view of an embodiment of the invention with the plunger cap removed and the plunger retracted to the aspiration position;

[0058] Figure 19 It is along Figure 18 A cross-sectional view taken along line 309-309;

[0059] Figure 20 yes Figure 18 a right side perspective view of an embodiment of the present invention with the needle retracted and the plunger fully advanced within the barrel;

[0060] Figure 21 It is along Figure 20 A cross-sectional view taken along line 311-311 in FIG.

[0061] Figure 22 yes Figure 12 A front elevation view of an embodiment of the invention;

[0062] Figure 23 yes Figure 22 Front elevational view of an embodiment of the present invention wherein the front attachment is repositioned relative to the barrel and the needle is retracted Figure 20 and Figure 21 The location shown;

[0063] Figure 24 is a perspective view from the front upper side of a medical syringe with a needle safety device according to an embodiment of the present invention;

[0064] Figure 25 Yes Figure 24 The syringe embodiment is shown with the needle cap and plunger cap removed;

[0065] Figure 26 Yes Figure 25 The illustrated embodiment of the syringe wherein the needle safety device is moved forward relative to the barrel and needle, and the needle tip shield surrounds and covers the needle tip;

[0066] Figure 27 yes Figure 24 An exploded top perspective view of an embodiment of a syringe;

[0067] Figure 28 yes Figure 24 A side view of an embodiment of a syringe;

[0068] Figure 29 yes Figure 24 A top plan view of an embodiment of a syringe;

[0069] Figure 30 It is along Figure 29 A cross-sectional view taken along line 420-420;

[0070] Figure 31 Yes Figure 25 Another side view of the illustrated embodiment of the syringe, but rotated 180° about the longitudinal axis;

[0071] Figure 32 Yes Figure 26 a side view of the illustrated embodiment of the syringe;

[0072] Figure 33 It is along the Figure 32a side cross-sectional view of the illustrated syringe embodiment taken along the longitudinal axis of the needle; and

[0073] Figure 34 Yes Figure 28 A bottom plan view of the illustrated embodiment of the syringe. DETAILED DESCRIPTION

[0074] The dose verification systems and methods herein are generally used to determine the actual volume of a dose of a medicinal fluid that is drawn or pre-filled by a user into a medical syringe prior to use. For the purposes of this disclosure, a medical syringe for use with the systems and methods herein may be any type of syringe or injection device (also referred to as a conventional syringe) that does not have any specialized features or structures, such as syringe 95 ( Figure 6 ), or may be a dedicated syringe according to an embodiment of the present invention, such as syringe 11 ( Figure 1 )、Syringe 320( Figure 11 ) or syringe 600( Figure 24 ), or having one or more features or structures of the dedicated syringe embodiments herein.

[0075] Typically, whether a dedicated or conventional medical syringe can include a syringe and a plunger having a plunger seal that slidably engages the generally cylindrical inner wall of the syringe to form an adjustable fluid chamber in the syringe. The medical syringe can also include a hypodermic needle that is arranged to be in fluid communication with the fluid chamber, extends forward from the distal end (or front end) of the syringe, and has its longitudinal axis roughly aligned with the longitudinal axis of the syringe before and during injection. The syringe and plunger are typically made of moldable medical grade plastic, but in some embodiments, other materials can be used, for example, the syringe can be made of glass. The syringe can also have volume markings to indicate the amount of medicinal fluid drawn into the syringe.

[0076] Medical syringes for use with the dose verification systems and methods herein may include electronic components, but such electronic components are not required to facilitate determining the actual dose of the medicinal fluid in the syringe using the dose verification systems and methods herein. Embodiments of the dedicated syringes disclosed herein for use with the dose verification systems and methods herein preferably do not include any electronic components.

[0077] refer to Figure 1 、 Figure 2 and Figure 5, shows one embodiment of a dose verification system 10. The dose verification system 10 may include a mobile imaging device 20 configured to capture a digital image of a medical syringe (such as syringe 11) or at least a portion of the medical syringe. The mobile imaging device 20 may be part of a cellular phone, a tablet computer, or a small laptop computer. The mobile imaging device 20 may include: a camera system configured to capture a digital image of at least a portion of the medical syringe having an actual dose of medicinal fluid, the volume of which is drawn or pre-filled prior to use; a processor configured to process the captured digital image to determine the volume of the actual dose of medicinal fluid in the medical syringe (referred to herein as the "actual volume," "actual dose," or "actual amount"); and storage / memory capabilities to optionally store the captured digital image, application software, and other data used in processing the captured digital image to determine the actual volume of the medicinal 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 an expected dose based on various data (e.g., a prescription or blood glucose reading). In some embodiments, the alert may be visual, audible, tactile, or any combination thereof.

[0078] The mobile imaging device 20 may include a display screen or window 24 that displays an image of an object (e.g., syringe 11) within a field of view 22 of the camera lens of the mobile imaging device 20. It should be understood that the size of the field of view 22 can vary depending on the spacing between the syringe 11 and the mobile imaging device 20, as well as the configuration, lens, focal length, and operating mode of the mobile imaging device 20. Figure 1 In the preferred embodiment shown, the field of view 22 covers the full length of the volume scale 25. However, it will be appreciated that the mobile imaging device 20 and associated capture software can capture images of the syringe 11 and correctly assess and / or verify the dose when the entire syringe 11 is not within the field of view.

[0079] The mobile imaging device 20 is preferably configured to be handheld by the user to capture a digital image of the syringe. Although the mobile imaging device 20 can be part of a wearable device such as mounted on a headband, glasses, lanyard / necklace, or wristband / watch (which allows the mobile imaging device 20 to capture digital images when worn by the user), the mobile imaging device 20 is most preferably not part of a wearable device that is attached to or supported by any part of the user's body other than the hand during use. The mobile imaging device 20 can be carried by the user in an item of clothing, such as a pocket, rather than being part of a wearable device because it will be removed and handheld during use. Thus, in some embodiments, the mobile imaging device 20 can be a cellular phone, tablet computer, or small laptop computer, and is configured to be portable. As such, the mobile imaging device 20, and therefore the dose verification system 10, can be used in a variety of locations and is not limited to any particular location.

[0080] like Figure 1 As shown, a preferred embodiment of the syringe 11 includes a wall extending laterally from the barrel 12, the wall having an outwardly facing indicia display surface 15 that is substantially flat and allows for an array of volume markings or volume graduations 25 to be printed, embossed, or molded thereon that correspond to the volumes in the fluid chamber of the syringe 11. In one preferred embodiment of the syringe 11, the barrel 12 is integrally molded from a transparent or translucent medical grade polymer and includes a volume graduation 25 having incremental markings 34 and accompanying numerical markings 36 that are printed, embossed, or molded on the flat, outwardly facing indicia display surface 15 (at the bottom). Figure 1 Incremental markings 34 and accompanying numerical markings 36 overlie the fluid chamber of the syringe and facilitate simultaneous viewing of the longitudinally extending cylindrical fluid chamber 62 ( Figure 5 ) contains a dose of medicinal fluid 26, the fluid chamber being defined at the rear by the forwardly facing surface 30 of the plunger seal 28 mounted on a forwardly extending extension 54 of the plunger handle 50 of the plunger 14.

[0081] The barrel 12 also includes a forwardly projecting hypodermic needle 16 that is coaxially aligned with the longitudinally extending cylindrical fluid chamber 62. Figure 1 、 Figure 3 and Figure 5As shown, the hypodermic needle 16 is biased rearwardly prior to injection within the laterally slidable front attachment 18. However, it should be understood that the dose verification systems and methods disclosed herein are not limited to use with medical injectors having retractable or retractable needles and associated mechanisms, and may similarly be used with medical injectors having, for example, fixed or attachable needles and with or without other needle safety features.

[0082] The cylindrical fluid chamber 62 is defined by the inwardly facing tubular wall portion of the syringe 12, which is integrally molded with the outwardly facing flat indicia display surfaces 15, 17. The syringe 12 is sufficiently transmissive to light that the forwardly extending end 30 of the plunger seal 28 and the medicinal fluid 26 drawn into the fluid chamber 62 of the syringe 12 are visible relative to the digital image display window 24 ( Figure 1 and Figure 2 ) are visible. For conventional medical syringes having fluid chambers of medium to large volume capacities (e.g., 5 mL; 10 mL), the diameter of the barrel diameter and its corresponding circumference generally allow for easy viewing of the placement of both the volume scale markings and the associated numerical markings from a single viewing position. However, for medical syringes having lower volume capacities (e.g., 0.5 mL; 1.0 mL), the smaller relative barrel diameter and circumference may result in the volume scale markings and the associated numerical markings encircling at least a portion of the barrel circumference, such that both are not clearly visible from a single viewing position, which may lead to medical errors when a dose of medicinal fluid is drawn into the syringe, further demonstrating the need for the syringe dose verification system and method disclosed herein. Moreover, printing the volume scale markings and the associated numerical markings on smaller syringe barrels may be an obstacle to the use of pad printing methods and equipment, which are preferably used to manufacture such products at the desired high production rates to reduce the unit cost of medical syringes. Some syringes may not have volume scale markings or numerical markings. It should be noted that the injector 11 does not contain any electronic components.

[0083] like Figure 1 and Figure 2As depicted in FIG, the mobile imaging device 20 can be a cellular phone having a camera system and imaging capabilities, a processor, and the ability to process captured digital images using application software. In some embodiments, the dose verification system 10 can be configured to selectively capture a digital image of the syringe 11 and display a digital readout 38 of the actual dose value withdrawn in the medical syringe 10 based on the captured digital image of the syringe 11. The digital readout 38 is preferably a numerical value, such as "0.46" mL. The digital readout 38 can be superimposed on the display window 24 displaying the captured digital image of the syringe 11, can be displayed on the display window 24 without displaying the captured digital image, and / or can be displayed on the display window 24 without interfering with the captured digital image. Figure 1 and Figure 2 The gradient grey shading in is intended to show a volume of medicinal fluid 26 being drawn into the fluid chamber of the medical syringe 11 for illustrative purposes. Figure 2 In the enlarged view depicted in FIG, the aspirated dose of medicinal fluid 26 is visible, wherein the forward-facing surface 30 of the plunger seal 28 and the handle 50 ( Figure 5 and Figure 6 ) The portion inside the syringe 12 is also visible in the digital image display window 24.

[0084] In some embodiments, the mobile imaging device 20 can be capable of capturing color images. Thus, in some embodiments, a medical syringe 11 used with the dose verification system 10 and method disclosed herein can advantageously include one or more colored components to assist image processing software or application software in the mobile imaging device 20 in identifying or distinguishing between different components. In some embodiments, this can enhance the accuracy of the dose verification system 10 and / or can enable the mobile 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 the security feature may also be manufactured using a material of a given color to visually emphasize the feature and help indicate its current operational state (e.g., ready for use with an exposed needle tip, or previously used with a retracted and / or covered needle tip). Such a color or color combination may also assist human users in making similar component and state identifications. The components may be of any visible color and may be referred to herein simply as "RGB elements," indicating that they may be more easily distinguished based on the colors used in the typical red-green-blue pixels of the digital mobile imaging device 20 or the colors of the human visible spectrum (including black and white).

[0086] Different components can be selectively colored to produce high visual contrast. Thus, in some embodiments, corresponding or related components of the syringe 11 to be imaged and / or components of the syringe 11 that move relative to each other can include colors that are considered to be opposite to each other on a color wheel (or contrasting colors), such as black / white, orange / blue, red / green, yellow / purple, and combinations thereof. In some embodiments, corresponding or related components of the syringe 11 to be imaged and / or components of the syringe 11 that move relative to each other can include gradient gray colors or shades that contrast or are distinguishable from each other. In some embodiments, corresponding or related components of the syringe 11 to be imaged and / or components of the syringe 11 that move relative to each other can include textures that contrast or are distinguishable from each other.

[0087] Any number of differently colored, shaded, or textured components can be used in the dose verification system 10 (e.g., two or more different colors, two or more different gradient shades of gray, or two or more different textures). Furthermore, any single component can have multiple portions that are each a different color; for example, the plunger 14 can include a seal 28, a handle 50, and a cap 52, each of which can be a different color. In some embodiments, contrasting or opposing colors can enhance the ability of the mobile imaging device 20 and / or software application to distinguish between different components to accurately verify a dose in the syringe 11, where the array of volume markings 36 or volume graduations 25 or the level of the medicinal fluid 26 in the syringe 11 is or is not fully visible. Thus, in some embodiments, the dose verification system 10 can use the relative positions of the distinguishable components to read and / or verify the dose of the medicinal fluid 26 in the syringe 11 before administering the injection.

[0088] In one embodiment, for example, for a transparent fluid in a sufficiently transparent syringe 12, the image processing software or application software in the dose verification system 10 can 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 dose verification system 10 can 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 can determine the actual dose of the medicinal fluid 26 based solely on the relative position of the cap 52 in the captured digital image. Therefore, in some embodiments, the volume scale 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 should be understood that in some embodiments, the volume markings 36 or an array of volume scales 25 can be used in conjunction with other imaging features of the dose verification system 10.

[0089] In one embodiment, for some fluids having distinguishable colors, the contrast between the color of the fluid and the color of the syringe 12 can be an identifiable feature for determining the actual dose by the dose verification system 10. In some embodiments, the plunger 14, the plunger seal 28, and / or the front surface 30 of the plunger seal 28 can be a different color than the syringe 12 so that the position of the plunger 14 within the syringe 12 can be more easily identified in the captured digital image, regardless of the fluid color. In the event that the dose verification system 10 knows the characteristics of the syringe 11 by identifying the syringe 11 during digital imaging or by selecting a particular syringe 11 by a user through a software application that moves the imaging device 20, the position of the plunger 14 in the captured digital image can be used to determine the actual fluid volume 62 in the syringe 12, even though the plunger 14 of the syringe 11 itself or even the syringe 12 may not bear volume markings.

[0090] In some embodiments, the syringe 12 can have a first color at the front end and a second color at the rear end, so that different portions of the syringe 12 can be identified in a captured digital image and analyzed by the dose verification system 10 regardless of the position of the plunger 14. The syringe 12 can also be colored in a gradient manner, such as from white to black with varying shades of gray along the length of the syringe 12, so that a portion of the syringe 12 in a captured digital image can be identified and measured by an image analysis tool, such as a digital imaging device 20, through the visible portions of the gradient gray in the image. Components of the syringe 11 can also be made of substantially the same colored materials, whether those materials are the same or different; this feature can direct the user's attention to any differently colored portions of the syringe 11, such as safety features.

[0091] The materials used in the components of the syringe 11 (or any other syringe used with the dose verification system 10 for digital verification) can have at least portions subjected to different surface treatments to produce a slightly roughened matte finish or a textured finish. By more evenly diffusing refracted light, the matte or textured surface can reduce or completely eliminate reflections or glare that can cause inaccuracies in image analysis software applications. Additionally, the textured surface can also distinguish one portion of the syringe 11 from the rest of the syringe 11 to aid in processing captured digital images, similar to the use of coloring to distinguish and verify the dose in the syringe 11. Thus, in some embodiments, the indicia display surface 15 can be transparent (or substantially transparent or translucent) and unroughened, excluding the markings 36, while the oppositely facing flat display surface 17 can be roughened to a matte finish to provide a better background, which results in a clearer view of the medicinal fluid 26 within the syringe 11. The incremental markings 36 on the volume scale 25 can be colored to enhance the contrast with the medicinal fluid and the syringe 12. In some embodiments, these markings 36 may also be printed over lines that have been laser etched to create a slightly roughened area where the print will transfer better.

[0092] To capture the digital image to be processed to determine the dose value, the mobile imaging device 20 can be positioned at any angle, distance, and / or orientation relative to the syringe 11, as long as the syringe 11 is within the field of view (i.e., field of view 22). Furthermore, the mobile imaging device 20 does not have to be positioned substantially perpendicular to the syringe 11 to capture the digital image. Embodiments of the software application in the dose verification system 10 are preferably configured to compensate for different camera positions (including different angles, distances, or both) relative to the syringe 11 when determining the actual dose volume from the captured image. Furthermore, embodiments of the software application can be configured to compensate for movement of the mobile imaging device 20 (or the camera of the mobile imaging device 20) during image capture. Thus, the dose verification system 10 can preferably be configured to compensate for slight hand movements or hand tremors of the user when using the mobile imaging device 20 to capture the digital image of the syringe 11. These features help allow the dose verification system 10 to utilize a handheld mobile imaging device 20, such as a cell phone, without requiring the imaging device to be mounted or requiring the use of a dedicated housing or mounting device to position the syringe 11 and the mobile imaging device 20 in any specific spatial relationship.

[0093] While a specific spatial relationship between the mobile imaging device 20 and the syringe 11 is not required for capturing a digital image and processing it to determine the actual dose, the dose verification system 10 can be configured to provide guidance to the user to promote an improved spatial relationship, thereby enhancing the digital imaging of the syringe 11. In some embodiments, the dose verification system 10 can implement an application that presents a geometric shape on the display window 24 to assist the user in aligning the mobile imaging device 20 and the syringe 11 for image capture. The geometric shape can include the outline of the syringe 11 or a different syringe similar to the syringe 11. The user can use the displayed geometric shape to modify the angle and distance of the mobile imaging device 20 relative to the syringe 11 so that the displayed geometric shape and the syringe 11 are substantially aligned, allowing for the capture of an improved digital image suitable for processing by the application. In another embodiment, the displayed geometric shape can be slightly larger than the outline of the syringe 11. This can allow the user to position the mobile imaging device 20 over the syringe 11 so that the image of the syringe 11 on the display window 24 is substantially contained within the displayed geometric shape. Thus, precise alignment of any displayed geometric shape on the display window 24 with the syringe 11 is not required for the dose verification system 10 to accurately determine or verify the actual dose of the medicinal fluid 26 in the syringe 11 .

[0094] refer to Figure 3 and Figure 4 , shows another embodiment of a dose verification system 75 according to an embodiment of the present disclosure. The dose verification system 75 can generally include a digital imaging device 40 that can be mounted to a cart or bed frame in a patient room, medical area or pharmacy via a device such as an articulated support rod 50 and adjustably positioned as needed to allow a user or medical caregiver to utilize the dose verification system 75 to verify the actual dose of the medicinal fluid 26 drawn into the syringe 11. As previously shown, and similar to the description of the dose verification system 10, the medical safety syringe 11 includes a syringe 12 that also includes an outwardly facing flat surface 15 having a volume scale 25 with individual incremental markings 34 and accompanying numerical markings 36 that cover a fluid chamber 62 (at Figure 5 As can be seen in Figure 3 and Figure 4 As shown, the digital imaging device 40 includes a display screen 44 defined by walls 46 and depicting an image captured within an adjustable field of view 42 focused on the upward facing flat image display surface 15 of the barrel 12 of the medical syringe 11 .

[0095] Although not in Figure 3, but it should be understood that the digital imaging device 40 can be operatively connected or connectable to a laptop computer or workstation configured to capture, process, record, store, and transmit the captured digital images as needed to verify the actual dose of medicinal fluid 26 drawn into the syringe 11 prior to injection, trigger an audible, visual, or tactile alarm as needed to notify the user or a third party if the drawn dose of medicinal fluid 26 is incorrect (e.g., too high or too low, generating a distinguishable alarm), and generate an archivable record of the dose administered in the injection for possible future use. In this way, the user can locally or remotely access a database containing the captured images (in addition to other data) and retrieve the captured images to view the dose associated with the volume scale 25 with incremental markings 34 and the accompanying digital marking 36 on the syringe (e.g., barrel, plunger, or other component), with or without text or numerical values ​​determined by image processing software. Thus, the dose verification system 75 can be capable of electronically reporting the dose of multiple injections without the need for manual data entry. Additionally, data derived from the captured image, time and date information, and linked data (eg, pharmacy records, prescriptions, etc.) can be retrieved locally or remotely from an electronic device such as a mobile communication device, tablet, or computer.

[0096] A first data set including information describing the syringe size and the corresponding syringe volume can be accessed to determine the actual dose volume based on geometric data extracted from the captured image. The first data set may also include the name of the medicinal fluid or information identifying the patient who received the actual dose. The first data set may also include the captured image itself. A second data set including a predetermined dose volume (i.e., the appropriate dose for a particular patient) may also be accessed for comparison with the actual dose volume. The predetermined dose volume can be based on medical records, including typical doses, medical records, insurance reports, bills, biometric readings such as blood glucose levels, and / or valid prescriptions. For example, in some embodiments, data from a glucose monitor can be associated with the predetermined dose volume required for a diabetic patient. If the actual dose volume is inconsistent with the predetermined dose volume or the typical dose volume for a given time of day, an alert can be provided to the patient.

[0097] Reference again Figure 3 and Figure 4, the display 44 provides a clear and focused view in a single image of the dose of medicinal fluid 26 drawn into the fluid chamber 62 of the barrel 12 in front of the front surface 30 of the plunger seal 28 of the plunger 14. Additionally, in some embodiments, the imaging device 40 can include a readout window 48 comprising a liquid crystal display or other display that can display a digital numerical readout of the dose of the medicinal fluid 26. For example, in the illustrated embodiment, the readout window 48 shows "0.46" (mL) as the volumetric dose of the medicinal fluid 26 drawn into the barrel 12 of the medical syringe 11 when the imaging device 40 and its associated software application interpret the dose based on the captured digital image.

[0098] Combine Figure 5 The structure and operation of the medical syringe 11 are further described and explained. The medical syringe 11 includes an integrally molded barrel 12 having two longitudinally extending passages: a fluid chamber 62 defined by cylindrical, inwardly facing walls; and a needle retraction chamber 64 extending longitudinally coextensive with and laterally offset from the fluid chamber 62 and sharing a common wall fluidically separating the fluid chamber 62 from the needle retraction chamber 64. The plunger 14 of the medical syringe 11 is depicted with the plunger handle 50 and plunger seal 28 partially inserted into the barrel 12. The protective needle cap (not shown) is removed to place the medical syringe 11 in a position for withdrawing a dose of medicinal fluid 26 from a vial (not shown) into the fluid chamber 62 ( Figure 5 ) state. After the hypodermic needle 16 has been inserted into the vial of medicinal fluid 26 or vaccine, when the plunger cap 52 of the plunger 14 is pulled back, the medicinal fluid 26 can enter the fluid chamber 62 in front of the front surface 30 of the plunger seal 28. Figure 5 As shown in the embodiment of the syringe 11, the safety feature of the syringe 11 is activated by applying lateral finger pressure to a touch pad (e.g., a needle safety actuator) of the front attachment 18, thereby causing 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 into the needle retraction cavity 64. This lateral repositioning allows the spring 56 that rearwardly biases the needle holder 58 containing the hypodermic needle 16 to expand, driving the needle holder 58 rearward into the needle retraction cavity 64 and also urging the sharpened front end of the hypodermic needle 16 rearward to a position where the needle tip is no longer exposed and will not cause an accidental needle stick after an injection.

[0099] According to the following Figures 6 to 9Another embodiment discussed in more detail provides a dose verification system 85 and method of use that can be effectively used with a medical syringe 95 having a syringe 112 where the level of the withdrawn dose is not clearly visible, or where the syringe 112 has illegible or difficult to read volume markings or indicia, or even when the syringe wall is opaque. Figures 6 and 7 , depicts a conventional syringe 95 of known nominal volume capacity having an optically clear barrel 112 without volume graduations or other visible numerical markings. In practice, some syringes are prefilled, and the volume capacity is sometimes incorporated into the packaging of such syringes rather than the syringe itself. A hypodermic needle 116 extends forwardly from the barrel 112, and a plunger 114 is fully inserted into the barrel 112, with the plunger seal 118 advanced into contact with the front end of the barrel 112.

[0100] A dose verification system 85 is disclosed for verifying the dose of a medicinal fluid disposed within a fluid chamber 120 of a transparent syringe 112 (as in a factory pre-filled syringe) that has no visible volume graduation markings or associated numerical indicia. Figure 8 The dose verification system 85 includes a mobile imaging device, which in the illustrated embodiment includes a cell phone 102 including a camera lens 104 having a field of view 106, the cell phone being positioned to capture and store one or more digital images from which the volume of the administered fluid dose can be recorded and stored prior to injection. The cell phone 102 can be configured and programmed, for example, using a downloadable software application to capture and store digital images from which the position of the plunger 114 relative to the syringe 112 and the volume of the administered fluid dose can be determined. Figure 8 Scale distances "A" and "B" are shown. Distance "A" represents the distance between the front of the fluid chamber 120 and the position of the plunger seal 118 after a dose is aspirated. Distance "B" represents the full length of the fluid chamber 120 when the plunger 114 is withdrawn to the "maximum fill position" (corresponding to the maximum rated volume capacity of the syringe 95). Assuming that the maximum rated volume capacity of the syringe 95 is known, the database is accessed locally or remotely by the software application, and the cell phone 102 is positioned relative to the syringe 95 so as to frame the syringe 95 within the field of view 106, and further assuming that the fluid chamber 120 has the same cross-sectional area at distances "A" and "B", as determined by the software application, the volume measurement of any lesser aspirated dose within the fluid chamber 120 can be determined by multiplying the ratio of A:B by the maximum rated volume capacity of the syringe 95.

[0101] In About Figure 9In the depicted embodiment, a dose verification system 100 is disclosed for verifying a dose of a medicinal fluid disposed within a fluid chamber of a syringe 122 of a medical syringe 96. In some embodiments, the syringe 122 may be opaque, translucent, textured, or include markings that prevent easy reading of the fluid level within the fluid chamber of the syringe 122. In some embodiments, the syringe 122 may not include visible volumetric graduation markings or associated numerical markings, which also hinders reading of the fluid level within the fluid chamber of the syringe 122. Figure 7 The plunger 114 can be used for a medical syringe 95 ( Figure 8 ) or medical syringe 96( Figure 9 ) which may include the same or substantially similar maximum rated volume capacity.

[0102] refer to Figure 9 The dose verification system 100 includes a mobile imaging device, which in the illustrated embodiment includes a cell phone 102 including a camera lens 104 having a field of view 108, the cell phone being positioned to capture and store one or more digital images from which the volume of the administered fluid dose can be determined and recorded prior to injection. The cell phone 102 can be configured and programmed, for example, using a downloadable application software, to capture and store digital images from which the position of the plunger 114 relative to the syringe 112 and the volume of the administered fluid dose can be determined. Figure 9 The scale distances shown are "D1" and "D2". Figure 9 108 , the graduated 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 associated volume of the fluid chamber within the syringe 122 is zero. By comparison, the graduated distance "D2" represents the distance from the barrel flange 126 to the thumb cap 124 of the plunger 114 when the plunger 114 is withdrawn after an injectable dose of medicinal fluid has been drawn into the syringe 122. Assuming that the maximum volumetric capacity of the syringe 96 is known, the database is accessed locally or remotely by the software application, and the cell phone 102 is positioned relative to the syringe 96 so as to frame the syringe 96 within the field of view 108, and further assuming that the fluid chamber within the syringe 122 has the same cross-sectional area over the distance the plunger 114 is withdrawn prior to injection as determined by the software application, when the fluid chamber of the syringe 122 is filled to the maximum rated volumetric capacity (as described above with respect to FIG. 108 ), the fluid chamber of the syringe 122 is filled to the maximum rated volumetric capacity (as described above with respect to FIG. 108 ). Figure 8 The volume measurement of the dose drawn within the fluid chamber of the syringe 122 can be determined by multiplying the maximum rated volume capacity of the syringe 96 by the ratio of "D2" minus "D1" to the total length of the fluid chamber ((D2-D1) / total length of the fluid chamber).

[0103] Figure 10 A schematic diagram of a dose verification system 200 is shown. The dose verification system 200 can generally be configured to verify and create a history of the dose of a medicinal fluid drawn into a fluid chamber of a medical syringe before administering an injection. The dose verification system 200 can include a portable imaging device 202 positioned to view and capture a digital image of a syringe 206 within a field of view defined by boundaries 208, 210, as previously described with respect to FIG. Figures 1 to 9 Fields of view 22 , 42 , 106 and 108 are further described.

[0104] In some embodiments, the portable imaging device 202 is configured by the application software 204 to focus on and capture a clear image of the marking display surface and volume scale (both the markings alone and with accompanying numbers) of the barrel of the syringe 206 associated with the dose of medicinal fluid drawn into the fluid chamber of the barrel of the syringe 206, as previously described with respect to the above Figures 1 to 9 The application software 204 may be downloaded to a mobile imaging device 202, such as a cell phone, tablet, or laptop computer that has digital imaging capabilities or is accessible via Wi-Fi, the Internet, or other known technologies. In some embodiments, the application software 204 may be configured via a digital signal processor 205 or other conventional, known processing devices and circuits to control, process, and transmit digital images viewed and captured by the imaging device 202 to a display 216, a storage device 220, or a medium (each of which may be external or contained within the imaging device 202), or operatively linked to another database that may be archived and indexed by the transmitter 212 and / or the report generator 222.

[0105] According to some embodiments of the dose verification system 200, the digital image viewed and captured by the imaging device 202 is optionally analyzed relative to predetermined parameters by a comparator 214 or other similarly effective device or circuit (with or without transmission to an external device), which is configured to generate a visual, audible, or tactile alarm 218 notifying the user that the dose of medicinal fluid drawn into the syringe 206 is correct. In some embodiments, the dose verification system 200 can also be configured to generate a visual, audible, or tactile alarm 218 notifying the user that the dose of medicinal fluid drawn into the syringe 206 is greater than or less than the prescribed or expected dose. Similarly, the dose verification system 200 can be configured to sequentially image the dose in the same syringe 206 multiple times 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 an acceptable range. In some embodiments, the dose verification system 200 can also record the date, time, and / or location of the dose with information regarding when the injection was administered. In some embodiments, the captured digital images can be stored locally on the digital imaging device 200 and / or uploaded to a cloud computing system or other database, which can allow for selective retrieval of the data in the future to verify dosage, review treatment history, etc.

[0106] In general, where components of the described techniques are implemented in whole or in part using software in one aspect, these software elements can be implemented to operate in conjunction with a computing component or one or more processing components capable of performing the described functionality. Even though various features or elements of functionality may be described or claimed separately as separate components, it will be understood by those skilled in the art that these features and functionality may be shared between one or more common software and hardware components. Thus, imaging device 202 is an exemplary computing component that may, in practice, represent a plurality of such components.

[0107] Application software 204 may also be implemented by computing or processing capabilities such as found in desktop computers, laptop computers and notebook computers, handheld computing devices (personal digital assistants (PDAs), smartphones, cellular phones, palmtops, etc.), mainframes, supercomputers, workstations or servers, or any other type of special-purpose computing device as may be desired or appropriate for a given application or environment. Processing may be implemented using a special-purpose processing engine, such as a microprocessor, controller, or other control logic. Such processing may also involve one or more memory components, such as random access memory (RAM) or other dynamic storage for storing information and instructions to be executed by the processor.

[0108] Thus, storage device 220 may include any fixed or removable media that is read, written, or accessed by application 204. As shown in these embodiments, storage device 220 may include a non-transitory computer-readable storage medium having stored or embedded computer software or data. The terms "computer program medium" and "computer-usable medium" are used to generally refer to media such as, for example, storage device 220. This and various other forms of computer program media or computer-usable media may involve sending one or more sequences of one or more instructions to a processing device for implementation. Such instructions contained on the medium are often referred to as "computer program code" or "computer program product" (which may be grouped in the form of a computer program or other grouping). When implemented, such instructions may enable system 200 to perform features or functions of the disclosed technology as discussed herein.

[0109] refer to Figure 11 , shows a medical syringe 320 according to an embodiment of the present disclosure. The medical syringe 320 includes a needle retraction mechanism and includes a needle cover 326 (including a locking member 340) and a plunger end cap 330, which are mounted in a position so that the syringe 320 can be safely packaged, shipped and stored. In this configuration, the locking member 340 of the needle cover 326 can limit lateral sliding of the front attachment 324 relative to the syringe barrel 322 before use. The syringe 320 can include a syringe barrel 322, which includes a substantially flat display surface 323, a front attachment 324, an outer wall 325 of a fluid chamber 375 (at Figure 19 ), a selectively removable needle cover 326, an array of volume measurement indicia 327, a finger flange 328, a removable plunger cap 330, and a locking member 340. Figure 11 As shown, primary volume measurement indicia 327 is applied to the substantially planar display surface 323, for example, including at least a number identifying the number of fluid cells and an associated primary measurement indicia. However, it should be understood that the drawings of these figures are for illustrative purposes, and the location of some features, such as the location of the secondary cell indicia 327 relative to the substantially planar display surface 323, may vary from the location shown. At least a portion of the secondary cell indicia 327 may begin on the substantially planar display surface 323 or be located proximate an edge of the substantially planar display surface 323, and optionally continue at least a short distance onto the curved outer wall of the fluid chamber 325. Such a location is understood to be within the operational capabilities of conventional pad printing techniques within the capabilities of one of ordinary skill in the art.

[0110] In some embodiments, an adhesive sticker (not shown) may be attached to the front of the syringe 322 or to a flat display surface 323 extending laterally from the syringe 322 (described later in detail). Figure 19The sticker may include information about the medicinal fluid, such as a medication label, or may include a QR code to provide remote access to the information. In some embodiments, the flat portion extending from the side of the syringe 322 may be laser etched to create a slightly roughened area, which may enhance adhesion of the sticker. The roughened area may also better retain ink, such as for printing auxiliary unit markings 327. In some embodiments, having printed indicia on the flat display surface 323 may help ensure proper orientation of the syringe 322 relative to the front attachment 324 during manufacturing, or help properly connect a separate needle connected to the syringe 322 when in use.

[0111] like Figure 11 , the syringe 320 has a front attachment 324 shown in a "before use" configuration with a needle cover 326 and a locking member 340 in place to prevent the front attachment 324 from translating laterally relative to the barrel 322 prior to use due to pressure inadvertently applied to the textured touchpad 346 or to the other side of the barrel 322. A removable plunger cap 330 is also mounted behind the finger flange 328 to prevent the plunger (not visible) from being accidentally withdrawn from the barrel 322 and to prevent inadvertent contamination of the interior of the rear opening of the barrel 322 or around the rearwardly extending handle portion of the plunger, as shown. Figure 19 As shown, which will be discussed below, the finger flange 328 includes a flat portion that can help keep the syringe 320 flat on the surface and not roll when the image is taken.

[0112] refer to Figure 12 、 Figures 14 and 15 and Figure 22 , the syringe 320's barrel 322 and front attachment 324 are shown in the same position as Figure 11 Same position, except the needle cover 326 (and locking member 340) are removed. The front opening into the needle retraction cavity 392 can be more clearly viewed, and the needle 334 is also visible, extending forwardly from the needle support member 332 of the front attachment 324. Circumferentially spaced axial tapered ribs 333 are provided around the needle support member 332 and provide a surface for frictionally engaging the inner surface of the needle cover 326 prior to removal. Figure 12 In the embodiment, the needle 334 and the fluid chamber 375 ( Figure 19 )'s longitudinal axes are coaxially aligned.

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

[0114] The syringe 320 includes a needle 334 with a forward-facing, angled needle tip 348 and a needle retraction mechanism, the needle retraction mechanism further comprising a helical compression spring 350 and a needle holder 352. The needle holder 352 also includes an elongated shaft 354 having a tubular bore 358 that is insertable into the rear portion of the spring 350. The diameter of the head 356 of the needle holder 352 is sufficiently greater than the inner diameter of the spring 350 so that the spring 350 can be held compressed by the head 356 when the front attachment 324 is slidably engaged with the front portion 64 of the syringe 322, as described below with respect to FIG. Figure 16 and Figure 17 The rear end of the needle 334 can be inserted into the tubular bore 358 of the needle holder 352 and can be attached in a fixed relationship to the interior of the elongated shaft 354 by any suitable, commercially available means, such as an adhesive. While the needle retraction mechanism as disclosed herein is satisfactory for use in the syringe 320, it should be understood that other similarly effective elements and mechanisms can be used that are useful for biasing the needle 334 rearwardly within the syringe 320.

[0115] Still refer to Figure 13 362 is insertable into the recess 66 in the front portion 364 of the barrel 322 such that when the needle retraction mechanism is installed within the front attachment 324 and the front attachment 324 is attached in slidable engagement with the front portion 364 of the barrel 322, the forward-facing end of the seal 360 is positioned in abutting contact with the rearward-facing head 356 of the needle holder 352. When the front attachment 324 of the syringe 320 is assembled to the front portion 364 of the barrel 322 during manufacture, access to the tubular longitudinally extending fluid chamber 375 (at Figure 19 Continuous, substantially straight fluid flow path (as seen in FIG).

[0116] In addition to the front portion 364, the syringe 322 also includes a substantially flat display surface 323, a curved outer wall surface 325, a finger flange 328, and a rearwardly extending annular collar 370. During assembly of the syringe 320, an elastomeric plunger seal 376 is installed on a forwardly extending boss 374 on 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 then completed by installing a substantially cylindrical plunger cap 330 on the rearwardly facing end of the syringe 322. The plunger cap 330 also includes an open front end 380, a cylindrical bore 382, ​​and a closed rear end 384. The plunger cap 330 is installed around the plunger thumb pad 378 and is frictionally engaged with the outer wall of the annular collar 370. As described with respect to Figure 11 Volume measurement indicia 327 applied as discussed also appear on the substantially flat display surface 323 and the outwardly facing portion of the curved outer wall surface 325 .

[0117] Figure 13 、 Figure 16 and Figure 21 Also disclosed is a forward-facing opening to a needle retraction chamber 392 relative to the front portion 364 of the syringe 322. The needle retraction chamber 392 has a closed rearward end adjacent the finger flange 328 and is defined by side walls 390, 395, a bottom wall 394, and a top wall that also includes the upward-facing, substantially flat display surface 323 of the syringe 322.

[0118] refer to Figure 16 and Figure 17 The assembly of the front portion 364 of the barrel 322 of the syringe 320 and the front attachment 324 is further described and explained. Figure 16 , annular fluid seal 360 (in Figure 13 The syringe 322 is first inserted into the recess 366 of the front portion 364 of the syringe 322. The front portion 364 also includes a top track 368 and a bottom track 369 extending laterally relative to the fluid chamber 375 ( Figure 19 ). Rounded attachment guides 396, 398 are disposed forward of the top rail 368 and the bottom rail 369, respectively, and are configured to facilitate assembly of the front attachment 324 to the front portion 364 of the barrel 322 by passing over and under arms connecting the textured touchpad 346 to the rear side of the front attachment 324.

[0119] refer to Figure 17 , an annular opening 412 is provided in the rear side of the front attachment 324 to facilitate insertion of the spring 350 and the needle holder 352, as described above with reference to Figure 13discussed, and the spring 350 is compressed at the front opening 342 (at Figure 21 377, 379 and is held in compression behind the head 356 of the needle holder 352 while the front attachment 324 is moved into sliding engagement with the front portion 364 of the syringe 322. The front attachment 324 also includes an upper guide 344 having a downwardly facing, laterally extending recess 400 and a lower guide 345 having an upwardly facing, laterally extending recess 402. The upper and lower ramps 404, 406 of the front attachment 324 are respectively configured to slide on two sets of laterally spaced opposing ramps having stop shoulders 377, 379 (at Figure 16 The lower group is not visible in the image).

[0120] When the front attachment 324 and the front portion 364 are as Figure 16 In the illustrated position, by sliding the front attachment 324 onto the front portion 364 of the syringe 322, the laterally extending top and bottom rails 368, 369 of the front portion 364 of the syringe 322 matingly engage the upper and lower recesses 400, 402, respectively. When pressure is applied to the textured touch surface 346, the front attachment 324 moves along the rails 368, 369 until the top and bottom stop shoulders 408 of the upper guide 344 pass over and then descend into confronting relation with the upper and lower stop shoulders 377. At this point, the needle support member 332 and the needle holder 352 ( Figure 16 and Figure 17 Not shown) is coaxially aligned with the longitudinal axis of the fluid chamber 75 (at Figure 9 Any movement of the front attachment 24 back to the Figure 6 Any attempt at the disengaged position shown would be hindered by the confronting and abutting contact between the upper and lower stop shoulders 377 of the front portion 364 and the top and bottom stop shoulders 408 , 410 of the front attachment 324 .

[0121] Figure 14 and Figure 15 Depicts Figure 12 320 with the needle cover removed and the plunger cap 330 still in place, and the textured touch surface 346 in the initial position relative to the barrel 322 as described above. The needle 334 is mounted within the aperture 358 of the needle holder 352, which is seated within the needle support member 332 of the front attachment 324, with the spring 350 compressed against the head 356 ( Figure 13The spring 350 applies a rearwardly directed biasing force to the needle holder 352 and the needle 334, and the needle holder is urged by the spring 350 to face and abut against the front surface of the annular fluid seal 60, thereby establishing a fluid chamber 375 (at the bottom) that passes through the needle 334, the needle holder 352 and the fluid seal 360 and enters the syringe 322. Figure 19 (as can be seen in the coaxial alignment of the fluid paths). Figure 14 and Figure 15 As shown, the plunger seal 376 is pushed fully forward into the substantially cylindrical fluid chamber 375 of the barrel 322.

[0122] refer to Figures 18 and 19 , the syringe 320 is configured so that fluid can be drawn into the syringe with the textured touchpad 46 again in the same initial position as previously described. Figure 12 、 Figures 14 and 15 ) is removed and the plunger handle 372 is withdrawn, drawing fluid into the fluid chamber 375. Figure 19 As can be seen in FIG, the needle retraction cavity 392 is substantially coextensive in length with the fluid chamber 375, thereby facilitating placement of the volume measurement indicia 327 on a substantially flat surface 323 (in FIG. Figure 13 ), which facilitates full utilization of the volume of fluid chamber 375 and also facilitates retraction of needles that are typically much longer than needle 334, such as biopsy needles (see below). Figure 21 After the fluid is drawn into the fluid chamber 375, the fluid can also be injected into the patient or expelled from the fluid chamber 375 by pushing the plunger thumb pad 378 forward while applying finger pressure to the forward-facing side of the flange 328.

[0123] refer to Figures 20 to 21 and Figure 23 , the plunger handle 372 and plunger seal 376 have been 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 attachment to a position where the needle support member 332 is aligned with the needle retraction cavity 392. Because the needle retraction cavity 392 has a larger front opening than the head 356 of the repositioned needle holder 352, the biasing force of the compression spring 352 pushes the needle holder 352 rearward and causes the needle holder 352 and needle 334 to be pushed into the distal end of the needle retraction cavity 392.

[0124] Reference again Figure 16 and Figure 17 , as referenced above Figures 20 to 21As depicted, further force is applied to the textured touch surface 346 of the front attachment 324 relative to the syringe 322, resulting in relative sliding movement between the front attachment 324 and the front portion 364 of the syringe 322. This movement causes the upper and lower ramps 404, 406 to slide over the second set of opposing ramps and the blocking shoulders 379, such that the top and bottom blocking shoulders 408 are placed in facing and abutting contact with the upper and lower blocking shoulders 379, thereby preventing the front attachment 324 from returning to the use position relative to the syringe 322.

[0125] Overall reference Figures 24 to 34 , specific reference Figures 24 to 27 , shows a syringe 600 according to an embodiment of the present invention. The syringe 600 is shown with a needle safety device 612. The syringe 600 may include a syringe barrel 610, a needle safety device 612, a needle cap 614, and a plunger cap 616. Figure 24 , the syringe 600 is shown with both the needle cap 614 and the plunger cap 616 in place, as they would be when the syringe 600 is first removed from its packaging. The syringe barrel 610 includes at least one longitudinally extending, substantially planar indicia display surface 620 marked with easily readable volume graduations. In one embodiment, the syringe barrel 610 includes two oppositely facing, substantially planar indicia display surfaces 620, 636 ( Figure 26 ). After removing the needle cap 614 and plunger cap 616 from the device ( Figure 24 ) after which the needle 625 extending forward and the plunger 624 extending backward ( Figure 25 ) becomes visible. The needle 625 is coaxially aligned with the plunger 624 and is held in fixed relation with the narrow hole 650 inside the nose 634 at the front end of the barrel 610 ( Figure 26 、 Figure 27 、 Figure 30 (Alternatively, it will be appreciated that needle 625 and nose 634 can be cooperatively configured such that needle 625 can be releasably attached to nose 634 if desired to allow different sized needles to be used with syringe 634.)

[0126] The hole 650 places the needle 625 in fluid communication with a fluid reservoir which is disposed within the tubular barrel 658 between the nose 634 and the plunger seal 660 on the front end of the plunger handle 640. Figure 30 ) or after injection ( Figure 33) The fluid chamber is not visible when the plunger handle 640 is pushed fully forward against the rear of the nose 634 of the barrel 610. When the syringe 600 is ready for an injection, as discussed below, when fluid is drawn into the syringe 600, the fluid reservoir is the space within the tubular segment 658 (not visible in these views) between the rear of the nose 634 and the front of the plunger seal 660.

[0127] refer to Figure 27 The needle safety device 612 further includes an activation handle 628 and a needle tip shield 632. The activation handle 628 further includes a rear end 668, a touch pad 626, and a pair of longitudinally extending channels 627 disposed on opposite sides of the activation handle 628. The function of the channels 627 is discussed below with respect to the sliding engagement with the syringe 610. The needle tip shield 632 further includes an inner bore 648 coaxially aligned with the needle 625 and the nose 634 of the syringe 610. The inner diameter of the needle tip shield 632 will allow the needle tip shield 632 to be positioned in a position where the needle 625 is positioned. Figure 25 、 Figure 31 The position shown slides over and around the coaxially aligned nose 634, and the needle tip shield 632 is long enough to slide over and around the nose 634 in the coaxially aligned position ... Figure 26 、 Figures 32 to 33 625 when moved forward as shown. A slight frictional engagement can be provided between the inner wall of the needle tip shield 632 and the nose 634 to help maintain the needle safety device 612 in a stable axial position relative to the syringe 610 during use of the syringe 600. The needle safety device 612 is integrally molded from a polymer material and is sized and configured to slidably engage the syringe 610 while also taking into account the range of needle lengths intended for use with the syringe 600. In one embodiment, the needle safety device 612 is made of a brightly colored material (e.g., red) to highlight its presence and intended use to the user.

[0128] Reference again Figure 27 The syringe 610 further includes a nose portion 634 coaxially aligned with the inner bore 650 and a tubular section 658 extending rearwardly from the nose portion 634 to the fingertip flange 618. The rear end of the tubular section 658 is open and communicates with the interior of the cylindrical, rearwardly extending collar 630 to which the plunger cap 616 is releasably attached. Figure 26) are parallel, longitudinally extending, substantially flat printable surfaces, each having oppositely facing volume scales including appropriate markings located adjacent the tubular segment 658 to facilitate easy reading of the liquid level within the tubular segment 658 by a user. A longitudinally extending track 656 having an inwardly projecting retainer edge 654 is disposed on the inwardly facing wall of each outwardly facing marking display surface 620, 636. The longitudinally extending track 656 is sized and configured to cooperatively engage each aligned channel 627 of the needle safety device 612 and provide a smooth, slidable interface along the channel. The syringe 610 is molded from a medical grade polymer material and is sufficiently transparent to allow a user to clearly view the level of liquid drawn into the tubular segment 658 of the syringe 600. Still referring to Figure 27 , the plunger 624 also includes a thumb cap 638 , a plunger handle 640 , a plunger seal retainer body 666 , and an annular recess 664 .

[0129] refer to Figures 25 to 27 、 Figure 30 、 Figures 32 to 33 The structural elements and operation of the mating arrangement of the needle safety device 612 relative to the barrel 610 of the syringe 600 are further described and explained. During assembly of the syringe 600, the activation handle 628 of the needle safety device 612 is aligned with and inserted over the tubular section 658 of the barrel 610, with the track 656 engaging the channel 627. The needle safety device 612 is moved rearward relative to the barrel 610 until 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. Sliding stops 642, each having a beveled surface 644 and a stop shoulder 652, are positioned rearward of the track 656 and forward of the rear stop 646. The opposing and facing beveled surfaces 644 allow the activation handle 628 to slide forward relative to the barrel 610 to a point where the needle tip shield 632 covers and protects the tip of the needle 625 after the syringe 610 is used. After the tip of the needle 625 is covered, the opposing and facing stop shoulders 652 prevent the activation handle 628 from moving rearwardly relative to the barrel 610 to re-expose the needle tip.

[0130] When the needle safety device 612 and the needle tip shield 632 are positioned relative to the syringe 610 and the needle 625 Figure 25 、 Figures 30 to 31 In the position shown (referred to as the "first stop position"), the needle tip shield 632 surrounds the nose 634 of the syringe and a portion of the needle 625. When the needle safety device 612 of the syringe 600 is in the first stop position, the front tip of the needle 625 can be inserted through the stopper of a medicine bottle (e.g., an insulin bottle), and by pulling back the plunger 624, which slidably engages the inner wall of the tubular section 658, the medicine can be drawn into the tubular section 658 ( Figure 27 、 Figure 30 ) in a fluid reservoir within.

[0131] After an injection or other use of the syringe 600, the needle safety device 612 is selectively moved forward to Figure 26 、 Figures 32 to 33 In the position shown, i.e., the "second stop position," the syringe 600 can be reconfigured to a "safe" position in which the needle tip is covered and prevented from inadvertent contact with a healthcare provider or patient. When the syringe 600 is configured with the needle safety device 612 in the second stop position, the front tip of the needle 625 is circumferentially surrounded by the needle tip shield 632 and (as shown in FIG. Figure 26 、 Figure 33 The front end of the needle tip shield 632 (shown) extends sufficiently forward of the tip of the needle 625 so that an individual will not suffer an accidental needle stick if the front end of the syringe 600 is pushed against his or her skin.

[0132] In various embodiments herein, an imaging device or camera can be used to capture an image of a syringe with a drawn dose without the need for a fixed staging area for the syringe or a mount for the camera to hold the camera at a fixed or selected distance above the syringe or at an angle relative to the syringe. Additionally, no specific geometry or markings are required for the surface on which the syringe with the drawn dose rests for capturing the image. A generally flat surface, such as a tabletop, is sufficient. The syringe to be imaged for dose verification can also be held in one hand of the user, with the imaging device held in the other hand. Images can be acquired to verify the dose without the need for specific or dedicated lighting, such as colored lighting or lighting of a specific wavelength, or specific or dedicated camera filters, such as a polarization filter. Adequate images can be captured using ambient lighting or the built-in flash on a cellular phone and only the camera hardware typically included in off-the-shelf smartphones.

[0133] The embodiments described herein with respect to the withdrawn dose in the syringe can also be applied to pre-filled doses. While pre-filled doses are generally accurate, it may be desirable to utilize a dose verification system or method according to embodiments herein to verify that the pre-filled dose is accurate and / or to verify that the particular pre-filled syringe selected for injection or administration is the correct syringe based on the patient's prescribed dose or medical data (e.g., to detect whether a user mistakenly selected a 1 mL pre-filled syringe when the prescribed dose is 2 mL and should have selected a 2 mL pre-filled syringe). In such embodiments, the syringe comprising the pre-filled dose may not include a needle, but may be configured with a needle attached to the syringe using various methods disclosed herein or other methods known in the art.

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

[0135] It should 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 the volume of a medicinal fluid drawn into a syringe, the syringe comprising: a syringe barrel; a fluid chamber disposed within the syringe barrel and configured to receive a volume of medicinal fluid in the syringe; and a plunger slidably engaged with the fluid chamber; wherein a first portion of the syringe has a first element; wherein a second portion of the syringe has a second element; and wherein the first element and the second element 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 syringe barrel, the position indicating the volume of the medicinal fluid drawn into the syringe.

[0137] Embodiment 2. The syringe of embodiment 1, wherein the barrel has no volume markings.

[0138] Embodiment 3. The syringe of any one of embodiments 1 to 2, wherein the plunger is devoid of volume markings.

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

[0140] Embodiment 5. The syringe of embodiment 4, wherein the first element and the second element contrast with the rest of the syringe.

[0141] Embodiment 6. The syringe of any one of Embodiments 1 to 5, wherein the first element is a first color, and wherein the second element 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 one of Embodiments 6 to 7, wherein the first color and the second color contrast with other portions 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 one 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 is devoid of volume markings.

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

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

[0154] Embodiment 19. The syringe of embodiment 18, wherein at least one of the first wall or the second wall comprises a substantially flat outer surface to allow the syringe to rest on a surface without rolling.

[0155] Embodiment 20. The syringe of embodiment 19 further comprising: a plurality of volume markings disposed on the substantially planar outer surface and adjacent the barrel.

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

[0157] Embodiment 22. The syringe of embodiment 1, wherein the barrel is colored in 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 outer surface of the barrel is textured to diffuse light refraction.

[0160] Embodiment 25. The syringe of embodiment 1 further comprising: a substantially planar wall extending laterally from the barrel; and a plurality of volume markings disposed on the substantially planar wall.

[0161] Embodiment 26. The syringe of embodiment 25, wherein the substantially planar wall comprises a textured surface to enhance adhesion of the at least one volume marking and the sticker.

[0162] Embodiment 27. The syringe of embodiment 26, wherein the sticker is printed with at least one of descriptive information about the medicinal fluid, a QR code for accessing the descriptive information about the medicinal fluid, and pharmacy information.

[0163] Embodiment 28. The syringe of any one of Embodiments 25 to 27, wherein the substantially planar wall is textured using laser etching.

[0164] Embodiment 29. The syringe of any one of Embodiments 25 to 28, wherein the plurality of volume markings assist in orienting the needle during manufacturing.

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

[0166] Embodiment 31. The syringe of embodiment 30, wherein the substantially planar wall is substantially free of texture other than the plurality of volume markings.

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

[0168] Embodiment 33. The syringe of any one of embodiments 1 to 32, further comprising: a laterally offset needle retraction cavity integrally molded with the barrel and extending longitudinally substantially to the same extent as the barrel and separated from the fluid chamber by a common wall; and a front attachment slidably engaged with a front portion of the barrel in a direction transverse to the longitudinal axis of the plunger, wherein a needle extending forwardly and biased rearwardly is disposed, the needle being selectively retractable into the needle retraction cavity after use.

[0169] Embodiment 34. The syringe of any one of Embodiments 1 to 33, wherein the syringe is free of electronic circuitry.

[0170] Embodiment 35. A system for verifying the accuracy of a dose of a medicinal fluid, the system comprising: a syringe comprising a syringe, a fluid chamber disposed within the syringe, a plunger slidably engaged with the fluid chamber, and a needle, the syringe being configured to draw an actual dose of medicinal fluid into the fluid chamber by moving the plunger backward in the fluid chamber; and a first data set comprising a predetermined volume ratio of the fluid chamber, the predetermined volume ratio being between a substantially full volume when the plunger is in a fully extended position relative to the syringe and a substantially empty volume when the plunger is in a fully inserted position relative to the syringe, the first data set being configured to be saved to a processor or accessed by the processor for use in a software application, thereby determining the volume of the actual dose based on a digital image of at least a portion of the syringe after the actual dose is drawn into the fluid chamber and the position of the plunger relative to the syringe is between the fully extended position and the fully inserted position.

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

[0172] Embodiment 37. The system of any one of embodiments 35 to 36, wherein the syringe is devoid of volume markings.

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

[0174] Embodiment 39. The system of any one of Embodiments 35 to 38, further comprising: a second data set comprising a predetermined dose volume based on at least one of a medication record, a medical history, an insurance report, a bill, a biometric reading, and a prescription, the second data set being configured to be saved to or accessed by the processor for use in a software application to compare with the volume of the actual dose to determine the accuracy of the actual dose.

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

[0176] Embodiment 41. A system according to any one of embodiments 35 to 40, wherein a first portion of the syringe has a first color, wherein a second portion of the syringe has a second color, and wherein the first color and the second color in the digital image can be distinguished from other portions of the syringe by a processor to determine the position of the plunger.

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

[0178] Embodiment 43. The system of any one of Embodiments 41 to 42, wherein the first portion is disposed on or near the front end of the syringe and the second portion is disposed on or near the rear end of the syringe.

[0179] Embodiment 44. The system of embodiment 43, wherein the syringe is sufficiently transparent to allow viewing of the medicinal fluid in the fluid chamber through the syringe.

[0180] Embodiment 45. The system of embodiment 44, wherein the syringe is colored in a partially transparent gradient color.

[0181] Embodiment 46. The system of embodiment 45, wherein the syringe is a gradient gray color.

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

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

[0184] Embodiment 49. The system of embodiment 43 further comprises: a second data set comprising a predetermined dose volume based on at least one of a medication record, a medical history, an insurance report, a bill, a biometric reading, and a prescription, the second data set being configured to be saved to or accessed by the processor for use in a software application to compare with the volume of the actual dose to determine the accuracy of the actual dose.

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

[0186] Embodiment 51. The system of any one of Embodiments 49 to 50, wherein the first color is orange.

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

[0188] Embodiment 53. The system of any one of embodiments 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 one of Embodiments 49 to 51, wherein the first color and the second color are substantially the same.

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

[0191] Embodiment 56. The system of any one of embodiments 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. A system according to any one of embodiments 43 or 55 to 56, wherein the first color and the second color are substantially the same.

[0194] Embodiment 59. A system according to any one of embodiments 35 to 47 or 55 to 58, further comprising: a laterally offset needle retraction chamber integrally molded with the syringe and extending longitudinally substantially to the same extent as the syringe and separated from the fluid chamber by a common wall; and a front attachment slidably engaged with the front portion of the syringe in a direction transverse to the longitudinal axis of the plunger, wherein a needle disposed therein extends forwardly and is biased rearwardly and is selectively retractable into the needle retraction chamber after use.

[0195] Embodiment 60. A method for verifying the accuracy of a dosage of a medicinal fluid, the method comprising: drawing an actual dose of the medicinal fluid into a fluid chamber of a syringe barrel, into a slidably engaged syringe, and into a subcutaneous needle; positioning a digital imaging device relative to the syringe, wherein the digital imaging device includes a camera, a processor, and a software application implemented by the processor, the software application configured to selectively view, capture, and store a digital image 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 fluid based on a position of the plunger relative to the syringe and a predetermined volume ratio between a substantially full volume of the fluid chamber when the plunger is in a fully extended position relative to the syringe and a substantially empty volume when the plunger is in a fully inserted position relative to the syringe.

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

[0197] Embodiment 62. A method according to any one of embodiments 60 to 61, wherein the digital imaging device is a cellular telephone.

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

[0199] Embodiment 64. The method of any one of embodiments 60 to 63, wherein the syringe is opaque.

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

[0201] Embodiment 66. A method according to any one of embodiments 60 to 62 or 64 to 65, wherein the rear portion of the plunger is disposed behind the barrel when the plunger is in the fully inserted position, and wherein the processing is based on the position of the rear portion of the plunger.

[0202] Embodiment 67. The method of any one of Embodiments 60 to 66, further comprising generating an alert to notify the user if a digital image of the syringe has already been stored.

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

[0204] Embodiment 69. The method of any one of Embodiments 60 to 68, further comprising: comparing the actual dose from the process with a predetermined dose of the medicinal fluid; and generating an alarm 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 dose is determined by cross-matching at least one of (1) the actual dose, the name of the medicinal fluid, or information identifying the patient to receive the actual dose with (2) at least one of a medication record, a medical record, an insurance report, a bill, and a prescription.

[0206] Embodiment 71. A method according to any one of embodiments 69 to 70, wherein the generating step generates a first alarm to notify the user if the actual dose is higher than the predetermined dose, and generates a second alarm to notify the user if the actual dose is lower than the predetermined dose; wherein the first alarm is distinguishable from the second alarm.

[0207] Embodiment 72. The method of any one of Embodiments 60 to 71, wherein the syringe does not have any external volume markings.

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

[0209] Embodiment 74. The method of any one 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 form a contrast.

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

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

[0213] Embodiment 78. The method of embodiment 77, wherein the plurality of volume markers are not used in determining the volume of the actual dose.

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

[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 to 80, wherein the first portion of the syringe is disposed at or near the front end of the barrel and the second portion of the syringe is disposed 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 substantially different from the first color.

[0218] Embodiment 83. The method of embodiments 80 to 81, wherein the first RGB element and the second RBG element are substantially identical.

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

[0220] Embodiment 85. The method of embodiments 60 to 62, wherein the syringe is a gradient gray color.

[0221] Embodiment 86. A method for injecting a verified dose of a medicinal fluid, the method comprising: 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 view, capture, and store a digital image of the syringe; drawing a dose of medicinal fluid into the fluid chamber; positioning the digital imaging device relative to the syringe; capturing and storing a digital image of the syringe and the medicinal fluid drawn into the fluid chamber; and processing the digital image to determine the dose of the drawn 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 if a digital image of the syringe has already been stored.

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

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

[0226] Embodiment 91. The method of embodiment 90, wherein the incorrect fluid dosage is determined by cross-matching the aspirated dose with at least one of a medication record, a medical record, an insurance report, and a bill.

[0227] Embodiment 92. A method according to any one 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 one 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 syringe.

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

[0230] Embodiment 95. A method according to any one 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 fluid, the system comprising: a syringe having a barrel and a plunger slidably engaged with a fluid chamber within the barrel, the syringe configured to draw an actual dose of medicinal fluid into the fluid chamber by moving the plunger backward in the fluid chamber; and an imaging device configured to selectively capture at least one digital image of a portion of the syringe; and a processor implementing a software application to determine the volume of the actual dose of the medicinal fluid based on the at least one digital image of the portion of the syringe.

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

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

[0234] Embodiment 99. The system of any one of embodiments 96 to 98, wherein the plunger has a first color and the syringe 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 contrast.

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

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

[0238] Embodiment 103. A system according to any one of embodiments 96 to 102, wherein the syringe includes a set of volume markings along the length of the fluid chamber, and at least a portion of the syringe adjacent the set of volume markings is sufficiently transparent to allow the actual dose of the medicinal fluid to be viewed through that portion of the syringe.

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

[0240] Embodiment 105. The system of embodiment 103, wherein the processor is configured to determine the volume of the actual dose based on the set of volume markings and a color difference between the medicinal fluid and the syringe.

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

[0242] Embodiment 107. A system according to embodiment 106, wherein the predetermined dose volume is determined by cross-matching at least one of (1) the actual dose, the name of the medicinal fluid, or information identifying the patient to receive the actual dose with (2) at least one of a medication record, a medical record, an insurance report, a bill, and a prescription.

[0243] Embodiment 108. A system according to any one of Embodiments 106 to 107, wherein the processor is configured to generate a first alarm to notify a user if the volume of the actual dose is higher than the predetermined dose volume, and to generate a second alarm to notify the user if the volume of the actual dose is lower than the predetermined dose volume, and wherein the first alarm is distinguishable from the second alarm.

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

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

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

[0247] Embodiment 112. A system according to any one of embodiments 96 to 111, wherein the imaging device is a mobile imaging device.

[0248] Embodiment 113. A system according to embodiment 112, wherein the mobile imaging device is a cellular telephone.

[0249] Embodiment 114. A system according to embodiment 112, wherein the mobile imaging device is a digital scanner.

[0250] Embodiment 115. A system according to any one 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 if the at least one digital image of the syringe has been stored.

[0252] Embodiment 117. The system of any one of Embodiments 96 to 116, further comprising: a comparator configured to generate an alarm to notify a user that an incorrect fluid dose has been drawn into the syringe.

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

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

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

[0256] Embodiment 121. The system of any one of embodiments 96 to 120, wherein the syringe is devoid of numerical markings.

[0257] Embodiment 122. The system of any one of Embodiments 96 to 120, wherein the syringe comprises an empty plunger position marking and a full plunger position marking.

[0258] Embodiment 123. The system of any one of embodiments 96 to 122, wherein the syringe has a known nominal volume capacity.

[0259] Embodiment 124. The system of any one 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 syringe.

[0260] Embodiment 125. The system of embodiment 124, wherein the imaging device uses a plunger position ratio calculation to determine the volumetric dose.

[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 aspirated dose from a digital image of the digital markings on the syringe.

[0264] Embodiment 129. A system according to any one of embodiments 96 to 128, wherein the syringe includes an outward-facing wall integrally molded with the inward-facing wall, the outward-facing wall having volume scales and numerical markings disposed on a flat display surface, the flat display surface extending longitudinally to the same extent as the fluid chamber so that the entire volume scale and numerical markings are visible relative to the plunger seal of the plunger.

[0265] Embodiment 130. The syringe of any one 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. The syringe of any one of Embodiments 96 to 129, wherein the portion of the syringe includes a plunger seal disposed about the plunger and engaged with the fluid chamber of the barrel and at least a portion of the barrel.

[0267] Embodiment 132. The syringe of any one 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 fluid, the system comprising: a device for injecting the medicinal fluid using a syringe, the syringe having an opaque barrel, a fluid chamber disposed within the barrel, a plunger slidably engaged with the barrel, and a subcutaneous needle; a device for positioning a digital imaging device relative to the syringe; a device for using the plunger to draw a dose of the medicinal fluid into the fluid chamber; a device for using the digital imaging device to view and selectively capture and store at least one digital image of the syringe and the medicinal fluid drawn into the fluid chamber; and a device for determining a volumetric dose of the medicinal fluid by processing the digital image.

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

[0270] Embodiment 135. A non-transitory computer-readable storage medium having a set of instructions embedded therein that, when implemented by one or more processors of a computer, causes the computer to implement an operation for verifying a dose of a medicinal fluid drawn into a syringe, the operation comprising: providing a syringe having an opaque barrel, a fluid chamber disposed within the barrel, a plunger slidably engaged with the barrel, and a subcutaneous needle; providing a digital imaging device configured to selectively view, capture, and store a digital image of the syringe containing the drawn dose of medicinal fluid; drawing a dose of medicinal fluid into the fluid chamber; positioning the digital imaging device relative to the syringe; capturing and storing a digital image of the syringe and the medicinal fluid drawn into the fluid chamber; and processing the digital image to determine the drawn dose of medicinal fluid.

[0271] However, the present disclosure can be implemented in many different forms and should not be interpreted as being limited to any specific structure or function presented throughout the present disclosure. On the contrary, these aspects are provided to make the present disclosure more thorough and complete, and the scope of the present disclosure will be fully conveyed to those skilled in the art. Based on the teachings herein, it will be understood by those skilled in the art that the scope of the present disclosure is intended to cover any aspect of the disclosure disclosed herein, whether it is realized independently of any other aspect of the present disclosure or realized in combination with any other aspect of the present disclosure. For example, any number of aspects set forth herein can be used to realize equipment or practice methods. In addition, the scope of the present disclosure is intended to cover such equipment or methods that are practiced using other structures, functions, or structures and functions other than the various aspects of the present disclosure set forth herein or that are different from the various aspects of the present disclosure set forth herein.

[0272] It should be understood that any aspect of the disclosure disclosed herein may be embodied by one or more elements of the claims. The word "exemplary" is used herein to mean "serving as an embodiment, instance or illustration". Any aspect described herein as "exemplary" is not necessarily to be construed as preferred or advantageous over other aspects. Although specific aspects are described herein, many variations and permutations of these aspects fall within the scope of the present disclosure. Although some benefits and advantages of preferred aspects are mentioned, the scope of the present disclosure is not intended to be limited to specific benefits, uses or purposes. The detailed description and drawings are merely illustrative of the present disclosure and are not limiting, and the scope of the present disclosure is defined by the appended claims and their equivalents.

[0273] Unless otherwise expressly stated, the terms and phrases used in this document and their variations should be interpreted as open-ended and non-restrictive. As an example, the term "including" should be interpreted as "including, but not limited to," etc.; the term "embodiment" is used to provide an illustrative example of the items being discussed, rather than an exhaustive or limiting list thereof; the terms "a" or "an" should be interpreted as meaning "at least one," "one or more," etc.; and terms such as "conventional," "traditional," "normal," "standard," "known," and similar meanings should not be interpreted as limiting the items described to a given time period or to items available at a given time, but should be interpreted as covering conventional, traditional, normal, or standard technology available or known at any time now or in the future. Similarly, where this document refers to technology that would be understood or known to one of ordinary skill in the art, such technology covers those technologies that would be understood or known to one of ordinary skill in the art at any time now or in the future. In some cases, the presence of expansion words and phrases such as "one or more," "at least," "but not limited to," or other similar phrases should not be interpreted as meaning that a narrower context is intended or required where such expansion phrases may not be present. The use of the term "component" does not imply that the components or functionality described or claimed as part of the component are all arranged in a common package. In fact, any or all of the various components of the component, whether control logic or other components, can be combined in a single package or maintained separately, and can be further distributed among multiple groups or packages or across multiple locations.

[0274] Other variations and modifications to the disclosure will also become apparent to those skilled in the art after reading this specification and viewing the drawings, and the scope of the disclosure herein is intended to be limited only by the broadest interpretation of the appended claims to which the inventor is legally entitled.

[0275] References herein to the front or forward, etc., generally refer to the direction toward the patient when using the syringe or other medical device herein, or to the direction from the plunger thumb cap or thumb flange toward the barrel nose. References herein to the rear or rearward or rearward or rearward, etc., refer to the direction substantially opposite to the front or forward, etc.

[0276] Any component, feature, or step indicated as preferred or preferred herein 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 with any other embodiment, even if not specifically described with such embodiment, unless it is specifically described as excluded from use with such embodiment.

Claims

1. A syringe for verifying the volume of a medicinal fluid drawn into the syringe, the syringe comprising: syringe; a fluid chamber disposed within the barrel and configured to receive a volume of medicinal fluid in the syringe; as well as a plunger slidably engaging the fluid chamber; wherein the first portion of the syringe comprises a first element; wherein the second portion of the syringe has a second element; and wherein, in a digital image of at least a portion of the syringe, the first element and the second element are distinguishable from other portions of the syringe by a processor to determine a position of the plunger relative to the barrel, the position of the plunger relative to the barrel indicating a volume of medicinal fluid drawn into the syringe.

2. The syringe according to claim 1, wherein There are no volume markings on the syringe, the plunger, or a combination thereof.

3. The syringe according to claim 1, wherein The first element and the second element are RGB elements.

4. The syringe according to claim 3, wherein The first element and the second element contrast with the rest of the syringe.

5. The syringe according to claim 1, wherein The first element is a first color, and wherein the second element is a second color.

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

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

8. The syringe according to claim 5, wherein The first color is different from the second color.

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

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

11. The syringe according to claim 1, wherein The syringe is opaque.

12. The syringe according to 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. The syringe according to claim 1, wherein The syringe is colored in a partially transparent gradient color.

14. The syringe according to claim 13, wherein The syringe is gradient gray.

15. The syringe according to claim 1, wherein At least a portion of the syringe includes a textured surface to diffuse light refraction.

16. A system for verifying dosage accuracy of a medicinal fluid, the system comprising: a syringe having a barrel and a plunger, the plunger slidably engaging a fluid chamber within the barrel, the syringe being configured to draw an actual dose of a medicinal fluid into the fluid chamber by rearward movement of the plunger in the fluid chamber; as well as An imaging device is configured to selectively capture at least one digital image of a portion of the syringe, and a processor implements a software application to determine a volume of an actual dose of medicinal fluid based on the at least one digital image of the portion of the syringe.

17. The system according to claim 16, wherein: The processor is configured to determine the volume of an actual dose of the medicinal fluid based on the position of the plunger relative to the barrel and a predetermined volume ratio of the fluid chamber, the predetermined volume ratio being a volume ratio 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.

18. The system according to 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 the plunger disposed within the fluid chamber of the barrel, (2) a plunger seal disposed about 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 volume of an actual dose based on the position of the plunger relative to the barrel.

19. The system according to claim 16, wherein: The processor is configured to determine the volume of the actual dose based on a color difference between the medicinal fluid and the syringe.

20. The system of claim 16, wherein: The processor is configured to compare the volume of an actual dose of the medicinal fluid with the volume of a predetermined dose of the medicinal fluid and generate an alarm to notify a user if the volume of the actual dose is higher, lower, or equal to the volume of the predetermined dose.

21. The system of claim 20, wherein: The volume of the predetermined dose is determined by cross-matching at least one of (1) the actual dose, the name of the medicinal fluid, or information identifying the patient to receive the actual dose with at least one of (2) a medication record, a medical history, an insurance report, a bill, and a prescription.

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

23. A method for verifying a dosage of a medicinal fluid, comprising: 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 view, capture, and store a digital image of the syringe; drawing a dose of a medicinal fluid into the fluid chamber; positioning the digital imaging device relative to the syringe; capturing a digital image of the syringe and the medicinal fluid drawn into the fluid chamber; as well as The digital image is processed to determine the dose of the medicinal fluid withdrawn.

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

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

26. The method according to claim 25, wherein The alarm is at least one of an audible alarm, a visual alarm, and a tactile alarm.

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

28. The method according to claim 27, wherein The incorrect fluid dosage is determined by cross-matching the aspirated dosage with at least one of a medication record, a medical record, an insurance report, and a bill.

29. The method according to claim 23, wherein The process is configured to determine the dose aspirated from a digital image of the position of the plunger handle relative to the syringe.

30. The method of claim 23, wherein: The process is configured to determine a dose drawn from the plurality of digital images.

Images