Syringe assembly detection system

Abstract

A detection system for a syringe assembly is disclosed that provides precision in monitoring the amount of fluid contained within the syringe barrel, detecting movement of the plunger within the syringe barrel, detecting the position of the plunger within the syringe barrel, and / or monitoring the volume received in or delivered by the syringe assembly. The detection system of the disclosure enables a sensor coupled to a portion of the plunger assembly to sense movement of the plunger rod relative to the syringe barrel by reading the scales bearing identifiers as the plunger rod with the sensor passes each respective scale bearing an identifier, thereby sensing the volume received in or delivered by the syringe.

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims the benefit of priority of U.S. Provisional Application No. 62 / 828,025, filed on April 2, 2019, entitled "Detection System for Syringe Assemblies", the entire disclosure of which is incorporated herein by reference.

[0002] Field of the Disclosure The present disclosure generally relates to a detection system for syringe assemblies. More specifically, the present disclosure relates to an identifier in a first portion of a syringe assembly and a sensor in a second portion of the syringe assembly that detects movement of the syringe assembly and monitors a volume received within or delivered by the syringe assembly.

Background Art

[0003] Description of Related Art Syringe assemblies, particularly subcutaneous syringes, are well-known in the medical field for dispensing fluids such as pharmaceuticals. Conventional syringes typically include a syringe barrel with an opening at one end and a plunger mechanism positioned through the opposite end. The plunger mechanism typically includes a plunger rod extending through the barrel, with a plunger head or stopper positioned at the end of the plunger rod within the syringe barrel, and a finger flange at the other end of the plunger rod extending outward from the syringe barrel. During use, the plunger rod is retracted through the syringe barrel to aspirate or fill the syringe barrel with a fluid such as a drug, and the plunger rod extends outward from the rear end of the syringe barrel. For drug delivery to the patient, the opening of the syringe barrel is adapted for fluid communication with the patient, for example, through a subcutaneous needle attached to the front end of the syringe barrel, or through a Luer-type fitting extending from the syringe barrel for attachment to the patient's fluid line. The user applies force to push the plunger rod and stopper down through the syringe barrel toward the front end, thereby pushing the contents of the syringe out of the barrel through the front opening for delivery to the patient. Such operations are well known in the medical field, and physicians are familiar with using such common fluid delivery procedures via standard syringes. [Overview of the Initiative] [Problems that the invention aims to solve]

[0004] Syringe barrels may include markings, such as graduations, on the side walls of the syringe barrel to provide an indication of the level or volume of fluid contained within the internal chamber of the syringe barrel. However, there is a need for a more accurate system for monitoring the volume of fluid contained within the syringe barrel, detecting the movement of the plunger within the syringe barrel, detecting the position of the plunger within the syringe barrel, and / or monitoring the volume received into or delivered by the syringe assembly. [Means for solving the problem]

[0005] Summary of the Invention This disclosure provides a syringe assembly detection system that provides accuracy in monitoring the amount of fluid contained in a syringe barrel, detecting the movement of a plunger in a syringe barrel, detecting the position of a plunger in a syringe barrel, and / or monitoring the amount received in or delivered by a syringe assembly.

[0006] The detection system of the present disclosure enables the detection of the movement of the plunger rod relative to the syringe barrel by a sensor connected to a portion of the plunger assembly, which directly reads the identifiers on the scales as the sensor-equipped plunger rod passes through each of the identifiers, each of which is also an identifier, thereby enabling the detection of the volume to be received in or delivered by the syringe.

[0007] According to embodiments of the present invention, the syringe assembly includes a syringe barrel having a first end, a second end, and a side wall extending between them and defining the interior; a plurality of graduations disposed on the side wall portion, each graduation containing an identifier; a plunger assembly having a plunger stopper portion slidably disposed inside the first end, the second end, and the syringe barrel, the plunger stopper portion being sized relative to the interior of the syringe barrel to provide a sealed engagement with the side wall of the syringe barrel; and a sensor connected to a portion of the plunger assembly, the sensor including a sensor that detects an identifier.

[0008] In one configuration, the sensor is located within a portion of the plunger assembly. In another configuration, the sensor is mounted on a portion of the plunger assembly. In yet another configuration, the sensor is formed as a portion of the plunger assembly. In one configuration, the scale is located on the inner portion of the sidewall. In another configuration, the syringe assembly includes a human-readable scale on the outer portion of the sidewall. In yet another configuration, the scale is located on the outer portion of the sidewall. In one configuration, the syringe assembly includes a human-readable scale on the outer portion of the sidewall. In another configuration, the identifier is part of the human-readable scale. In yet another configuration, the identifier is transparent. In one configuration, the identifier is magnetic. In another configuration, the sensor is a magnetic sensor. In yet another configuration, the identifier is IR ink. In one configuration, the sensor is an optical sensor. In another configuration, the identifier is UV ink.

[0009] According to another embodiment of the present invention, the syringe assembly includes a syringe barrel having a first end, a second end, and a side wall extending between them and defining the interior; a plurality of graduations arranged on the portion of the side wall, each of which graduations includes an identifier; a plunger rod having the first end and the second end; a stopper engaging with the second end of the plunger rod and slidably disposed inside the syringe barrel, the stopper being sized relative to the interior of the syringe barrel to provide a sealed engagement with the side wall of the syringe barrel; and a sensor for detecting the identifier.

[0010] In one configuration, the sensor is located within a portion of the plunger rod. In another configuration, the sensor is attached to a portion of the plunger rod. In yet another configuration, the sensor is formed as part of a portion of the plunger rod. In one configuration, the sensor is located within a portion of the stopper. In another configuration, the sensor is attached to a portion of the stopper. In yet another configuration, the sensor is formed as part of a portion of the stopper. In one configuration, the graduations are located on the inner portion of the sidewall. In another configuration, the syringe assembly includes human-readable graduations on the outer portion of the sidewall. In yet another configuration, the graduations are located on the outer portion of the sidewall. In one configuration, the syringe assembly includes human-readable graduations on the outer portion of the sidewall. In another configuration, the identifier is the portion of the human-readable graduations. In yet another configuration, the identifier is transparent. In one configuration, the identifier is magnetic. In another configuration, the sensor is a magnetic sensor. In yet another configuration, the identifier is IR ink. In one configuration, the sensor is an optical sensor. In another configuration, the identifier is UV ink.

[0011] The above and other features and advantages of this disclosure, as well as the methods for achieving them, will become more apparent and the disclosure itself will be better understood by referring to the following description of embodiments of the disclosure, which are taken into account in conjunction with the accompanying drawings. [Brief explanation of the drawing]

[0012] [Figure 1] This is an assembled perspective view of a syringe assembly in a first position, equipped with a detection system, according to an embodiment of the present invention. [Figure 2] This is an assembled perspective view of a syringe assembly in a first position, equipped with a detection system, according to another embodiment of the present invention. [Figure 3] This is an assembly drawing of a syringe assembly in a second position, equipped with a detection system, according to another embodiment of the present invention. [Figure 4]This is an assembly drawing of a syringe assembly in a second position, equipped with a detection system, according to another embodiment of the present invention. [Figure 5] This is an assembly drawing of a syringe assembly in a second position, equipped with a detection system, according to another embodiment of the present invention. [Figure 6] This is an exploded perspective view of a syringe assembly equipped with a detection system, according to another embodiment of the present invention. [Modes for carrying out the invention]

[0013] Corresponding reference figures indicate the corresponding parts through several figures. The examples described herein illustrate exemplary embodiments of the disclosure, and such examples should not be construed as limiting the scope of the disclosure in any way.

[0014] Detailed explanation The following description is provided to enable those skilled in the art to create and use the described embodiments intended for carrying out the invention. However, various modifications, equivalents, variations, and substitutes will remain readily apparent to those skilled in the art. All such modifications, variations, equivalents, and substitutes are intended to fall within the spirit and scope of the invention.

[0015] For the purposes of the following description, the terms “up,” “down,” “right,” “left,” “vertical,” “horizontal,” “peak,” “bottom,” “side,” “vertical,” and their derivatives will be relevant to the present invention as they are directed toward the drawings. However, it should be understood that the present invention may envision various alternative modifications unless expressly otherwise specified. It should also be understood that the particular devices shown in the accompanying drawings and described in the following specification are merely illustrative embodiments of the present invention. Accordingly, certain dimensions and other physical characteristics relating to the embodiments disclosed herein should not be considered limiting.

[0016] This disclosure provides detection systems for fluid containers, such as syringe assemblies, IV bags, pen syringes, and auto-injectors, which provide accuracy in monitoring the amount of fluid contained in the container, detecting the movement of a plunger within the container, and / or monitoring the amount received into or delivered by the fluid container. In one embodiment, this disclosure provides a syringe barrel detection system for detecting the movement of a plunger within the syringe barrel, detecting the position of the plunger within the syringe barrel, and / or monitoring the volume received into or delivered by the syringe assembly.

[0017] The detection system of the present disclosure enables the detection of the movement of the plunger rod relative to the syringe barrel by a sensor connected to a portion of the plunger assembly, which directly reads the markings having identifiers as the plunger rod equipped with the sensor passes each of the markings having identifiers, thereby enabling the detection of the volume to be received into or delivered by the syringe.

[0018] Referring to Figures 1-6, a fluid container such as a syringe assembly 10 having a detection system 18 includes a syringe barrel 12, a plunger rod or plunger assembly 14, and a stopper 16. The syringe assembly 10 may be adapted for dispensing and delivering fluids and / or collecting fluids. For example, the syringe assembly 10 may be used for injecting or infusing fluids such as drugs into a patient. The syringe assembly 10 is intended for use connected to a needle, for example by connecting the syringe assembly 10 to a separate needle assembly (not shown), or to an intravenous (IV) connection assembly (not shown). It should be recognized that this disclosure may be used with any type of syringe assembly. These types of syringes include conventional pre-filled syringe assemblies, metered syringes, and aspiration syringes for drawing fluids from a patient or drugs from a container. Also, as used herein, fluid containers are intended to be IV bags, pen syringes, auto-injectors, patch syringes, etc.

[0019] Referring to FIGS. 1-6, the syringe barrel 12 generally includes a barrel body or sidewall 30 that extends between a first or distal end 32 and a second or proximal end 34. The sidewall 30 includes an outer surface or outer portion 44 and an inner surface or inner portion 46. The proximal end 34 of the syringe barrel 12 defines a proximal opening 35 (FIG. 6). The sidewall 30 defines an elongated opening or internal chamber 36 of the syringe barrel 12. In one embodiment, the internal chamber 36 can extend the extent of the syringe barrel 12, and the syringe barrel 12 can be cannulated along its entire length. In one embodiment, the syringe barrel 12 is of a general shape of a hypodermic syringe and can be of a general form of an elongated cylindrical barrel, as is known in the art. In an alternative embodiment, the syringe barrel 12 can be of other forms for containing a fluid for delivery, such as, for example, a general form of an elongated rectangular barrel. The syringe barrel 12 can be formed of glass or injection molded from a thermoplastic material such as polypropylene and polyethylene, according to techniques known to those skilled in the art, it should be recognized that the syringe barrel 12 can be made from other suitable materials and according to other applicable techniques. In certain configurations, the syringe barrel 12 can include a flange 40 that extends outwardly around at least a portion of the proximal end 34. The flange 40 can be configured for easy gripping by a physician.

[0020] The distal end 32 of the syringe barrel 12 includes an outlet opening 38 that is in fluid communication with the chamber 36. The outlet opening 38 may be sized and adaptable for engagement with a separate device, such as a needle assembly or an IV connection assembly, and may therefore include a conventionally known engagement mechanism. For example, the distal end 32 may include a tapered Luer tip 42 for engagement with an optional separate tapered Luer structure (not shown) for mounting to such a separate device. In one configuration, both the tapered Luer tip 42 and the separate tapered Luer structure may be provided on the syringe assembly 10. In such a configuration, the separate tapered Luer structure may be fitted with a mounting mechanism, such as a threaded engagement, for corresponding engagement with the separate device (not shown). In another configuration, the tapered Luer tip 42 may be provided for direct engagement with the separate device (not shown). Furthermore, the mechanism for locking the engagement between them may also comprise at least one of the tapered luer tips 42 and / or a separate tapered luer structure such as a luer collar or luer lock including an internal thread. Such luer connection and luer locking mechanisms are well known in the art.

[0021] The proximal end 34 of the syringe barrel 12 is generally an open end, but is intended to be closed off from the external environment. For example, in one embodiment, the proximal end 34 of the syringe barrel 12 defines a proximal opening 35 (Figure 6).

[0022] The syringe assembly 10 may be useful as a pre-filled syringe and thus may be provided for final use with a fluid such as a drug or medicament contained within the internal chamber 36 of the syringe barrel 12 pre-filled by a manufacturer. In this way, the syringe assembly 10 is manufactured, pre-filled with the medicament, sterilized for delivery and storage, and can be used by an end user without the need for the end user to fill the syringe with the medicament from a separate vial prior to use. In such an embodiment, the syringe assembly 10 may include a protective cap disposed over the outlet opening 38 at the distal end 32 of the syringe barrel 12 to seal a fluid F such as a medicament within the internal chamber 36 of the syringe barrel 12. The syringe assembly 10 may also include additional packaging and sealing to contain the syringe assembly 10 for sealing and protecting the fluid F such as a drug within the internal chamber 36 of the syringe barrel 12.

[0023] The syringe assembly 10 may also be used to fill the syringe barrel 12 with a medicament from a separate vial prior to use. For example, the syringe assembly 10 may be used with an unfilled dosing kit such as a diabetes treatment kit or other dosing kit.

[0024] Referring to Figures 1-6, in one embodiment, the syringe assembly 10 includes a stopper 16 that is movably or slidably positioned within an internal chamber 36 and engages with the internal surface of the side wall 30 of the syringe barrel 12. The stopper 16 is sized relative to the interior of the syringe barrel 12 and provides a seal engagement with the internal surface 46 of the side wall 30 of the syringe barrel 12. In a pre-filled syringe assembly, the stopper 16 also provides a first seal to prevent liquid or drug from leaking out of the syringe barrel 12. Furthermore, in one embodiment, the stopper 16 may include one or more annular ribs 48 extending around the stopper 16 to increase the seal engagement between the stopper 16 and the internal surface 46 of the side wall 30 of the syringe barrel 12. In an alternative embodiment, a single or multiple O-rings may be circumferentially positioned around the stopper 16 to increase the seal engagement with the internal surface of the side wall 30.

[0025] Referring to Figures 1-6, the syringe assembly 10 further includes a plunger rod 14 which provides a mechanism for distributing the fluid contained in the internal chamber 36 of the syringe barrel 12 through the outlet opening 38.

[0026] The plunger rod 14 is adapted to advance the stopper 16. In one embodiment, the plunger rod 14 is sized to move within the internal chamber 36 of the syringe barrel 12 and generally includes a first or distal end 60 that can engage with a portion of the stopper 16, a second or proximal end 62 generally opposite the first end 60, a plunger rod body 64 extending between the first end 60 and the second end 62, and a flange 66 positioned adjacent to the second end 62.

[0027] Referring to Figures 1-6, in one embodiment, the plunger rod 14 includes a stabilizing rib 74 extending between the distal end 60 and the proximal end 62 of the plunger rod 14. In one embodiment, the stabilizing rib 74 extends along the longitudinal axis of the plunger rod 14. In other embodiments, the stabilizing rib 74 may include one or more annular ribs extending around the plunger rod 14. The stabilizing rib 74 provides means for stabilizing and guiding the plunger rod 14 within the syringe barrel 12 during its movement within the internal chamber 36 of the syringe barrel 12.

[0028] Referring to Figures 1-6, the plunger rod 14 includes a first end 60 that can engage with a portion of the stopper 16. In one embodiment, the plunger rod 14 and the stopper 16 may include an engaging portion for securing the plunger rod 14 to the stopper 16. For example, the engaging portion may include a corresponding threaded portion for securing the plunger rod 14 to the stopper 16. In other embodiments, the engaging portion may include a snap-fit ​​mechanism, a press-fit mechanism, a ball detent, a locking tab, a spring-loaded locking mechanism, a latch, an adhesive, or other similar mechanism. In another embodiment, the plunger rod 14 and the stopper 16 may be co-molded by co-extrusion or the like. The plunger rod 14 is locked to the stopper 16, i.e., significant relative movement between the plunger rod 14 and the stopper 16 is prevented, and the movement of the plunger rod 14 may be transferred to the stopper 16, causing the stopper 16 to slide between positions within the syringe barrel 12. In other embodiments, the plunger rod 14 and the stopper 16 may be formed integrally as a plunger assembly.

[0029] All components of the syringe assembly 10 may be made of any known material, preferably a medical-grade polymer.

[0030] This disclosure provides a detection system 18 for a syringe assembly 10 that provides accuracy in monitoring the amount of fluid contained in a syringe barrel 12, detecting the movement of a plunger 14 in the syringe barrel 12, detecting the position of the plunger 14 in the syringe barrel 12, and / or monitoring the volume received in or delivered by the syringe assembly 10. Referring to Figures 1-6, in one embodiment, the detection system 18 for a syringe assembly 10 includes an identifier 80 which is part of a first part of the syringe assembly 10 and a sensor or sensing device 82 which is part of a second part of the syringe assembly 10. The detection system 18 of the present disclosure enables a sensor 82 connected to a portion of the syringe assembly 10 and / or plunger assembly 14 to sense the movement of the plunger 14 relative to the syringe barrel 12 by directly reading the scale 84 having identifiers 80 as the plunger rod 14 equipped with the sensor 82 passes each of the scales 84, each having an identifier 80, thereby enabling the system to sense the volume to be received into or delivered by the syringe 10.

[0031] In one embodiment, the syringe barrel 12 includes a first set of markings or scales 84 positioned on a portion of the side wall 30 of the syringe barrel 12 to provide an indication of the level or volume of fluid contained in the internal chamber 36 of the syringe barrel 12 and to provide an indication of additional information as described herein. Such markings 84 may be provided on the outer surface or outer portion 44 of the side wall 30, the inner surface or inner portion 46 of the side wall 30, or integrally formed, or otherwise provided within the side wall 30 of the syringe barrel 12. In other embodiments, alternatively or in addition, the markings 84 may also provide other identifying information known in the art, such as a description of the contents of the syringe or the maximum and / or minimum filling lines.

[0032] Each of the multiple markings or scales 84 may include an identifier 80 detectable by a sensor 82. For example, in one embodiment, the identifier 80 includes a scale marking 84 printed on the syringe barrel 12 using magnetic ink. In such an embodiment, part of the syringe assembly 10 or plunger rod 14 includes a sensor 82, for example, a magnetic sensing sensor, which is detectable by each of the identifiers 80, i.e., the sensor 82 detects the magnetic ink forming the scale marking 84. In this way, the identifiers 80 and the sensor 82 form a detection system 18 that provides accuracy in monitoring the amount of fluid contained in the syringe barrel, detecting the movement of the plunger in the syringe barrel, detecting the position of the plunger in the syringe barrel, and / or monitoring the volume supplied by the syringe assembly.

[0033] Referring to Figure 1, in one embodiment, the syringe barrel 12 may include a first identifier 100, which includes a graduation marking 84 printed on the syringe barrel 12 using magnetic ink; a second identifier 102, which includes a graduation marking 84 printed on the syringe barrel 12 using magnetic ink; a third identifier 104, which includes a graduation marking 84 printed on the syringe barrel 12 using magnetic ink; a fourth identifier 106, which includes a graduation marking 84 printed on the syringe barrel 12 using magnetic ink; a fifth identifier 108, which includes a graduation marking 84 printed on the syringe barrel 12 using magnetic ink; and a sixth identifier 110, which includes a graduation marking 84 printed on the syringe barrel 12 using magnetic ink. In some embodiments, an additional identifier 80, which includes a graduation marking 84 printed on the syringe barrel 12 using magnetic ink, may be included on the syringe barrel 12 for a particular application. In other embodiments, fewer identifiers 80 may be included in the syringe barrel 12 for other applications, including graduated markings 84 printed on the syringe barrel 12 using magnetic ink. It is assumed that the detection system 18 of the present disclosure can be adapted to include any number of identifiers 80 in any particular pattern for various different applications.

[0034] In this way, as the plunger rod 14 moves from the fully retracted position shown in Figure 3 toward the distal end 32 of the syringe barrel 12 in a direction approximately along arrow B (Figure 3), the sensor 82 can determine the movement along the syringe barrel 12 by detecting the printed patterns of magnetic ink in identifiers 100, 102, 104, 106, 108, and 110. Furthermore, in this manner, the detection system 18 of the present disclosure also provides accuracy in monitoring the amount of fluid contained in the syringe barrel, detecting the movement of the plunger within the syringe barrel, detecting the position of the plunger within the syringe barrel, and / or monitoring the volume supplied by the syringe assembly.

[0035] In other words, the detection system 18 of the present disclosure enables the detection of the movement of the plunger rod 14 relative to the syringe barrel 12 by a sensor 82 connected to a portion of the syringe assembly 10 or the plunger rod 14, which directly reads the scale 84 having identifiers 80 as the plunger rod 14, equipped with the sensor 82, passes each of the scales 84, each having an identifier 80, thereby enabling the detection of the volume received into or delivered by the syringe 10.

[0036] Referring to Figure 1, in one embodiment, the weights of the lines for identifiers 100, 102, 104, 106, 108, and 110 are varied so that the intensity of the signal detected by the sensor 82 provides information about the absolute position of the plunger rod 14 relative to the syringe barrel 12.

[0037] As described above, in one embodiment, the detection system 18 of the Disclosure includes a magnetic sensor 82 paired with a magnetic ink identifier 80. In other embodiments, the detection system 18 of the Disclosure may include other pairs of sensors 82 with the identifier 80.

[0038] For example, referring to Figure 2, in another embodiment, the identifier 80 includes a graduation marking 84 printed on the syringe barrel 12 using UV-reflective ink. In such an embodiment, a portion of the syringe assembly 10 or plunger rod 14 includes a sensor 82 capable of detecting each of the identifiers 80, i.e., the sensor 82 detects the UV-reflective ink forming the graduation marking 84. In this way, the identifiers 80 and the sensor 82 form a detection system 18 that provides accuracy in monitoring the amount of fluid contained in the syringe barrel, detecting the movement of the plunger in the syringe barrel, detecting the position of the plunger in the syringe barrel, and / or monitoring the volume supplied by the syringe assembly. In such an embodiment, the sensor 82 can more easily read information regarding the syringe graduation by an enhanced signal provided to the sensor 82 by the UV-reflective ink. In such an embodiment, UV or other invisible optically active inks may be used to enhance the function of the sensor 82 and the generated signal. In this specification, identifier 80 is also intended to include other information that would otherwise be printed on a label applicable to the device, such as the type of fluid container and / or the contents of the fluid container. By including this type of information within identifier 80, the information that would otherwise be printed on the label will not interfere with or interfere with the user's normal use of the visible markings, contents, or volume of the syringe.

[0039] In another embodiment, the identifier 80 includes a graduation marking 84 printed on the syringe barrel 12 using IR ink. In such an embodiment, a portion of the plunger rod 14 includes a sensor 82, for example, an optical sensor, capable of detecting each of the identifiers 80, i.e., the sensor 82 detects the IR ink forming the graduation marking 84. In this way, the identifiers 80 and the sensor 82 form a detection system 18 that provides accuracy in monitoring the amount of fluid contained in the syringe barrel, detecting the movement of the plunger in the syringe barrel, detecting the position of the plunger in the syringe barrel, and / or monitoring the volume supplied by the syringe assembly.

[0040] Referring to Figures 4 and 5, in some embodiments, the sensor 82 is located within a portion of the plunger rod 14 or stopper 16 and detects an identifier 80 that forms a scale marking 84, and determines the position of the plunger rod 14 based on this detection. In other embodiments, the sensor 82 may be connected to other portions of the plunger rod 14 and / or stopper 16. For example, in other embodiments, the sensor 82 may be attached to a portion of the plunger rod 14, the sensor 82 may be formed as part of a portion of the plunger rod 14, the sensor 82 may be located within a portion of the stopper 16, the sensor 82 may be attached to a portion of the stopper 16, or the sensor 82 may be formed as part of a portion of the stopper 16. For example, referring to Figures 2 and 3, in some embodiments, the sensor or sensing device 82 may be connected to a portion of the plunger assembly 14 and located outside the syringe barrel 12. In some embodiments, referring to Figure 6, the sensor 82 may be part of the stopper 16.

[0041] In one embodiment, the syringe barrel 12 may include a first set of markings or scales 84 having an identifier 80, and a second set of markings or scales 86 having a human-readable scale.

[0042] Referring, for example, to Figure 5, in one exemplary embodiment, a first set of markings, or scales 84, having an identifier 80, is located on the inner portion 46 of the side wall 30 of the syringe barrel 12, and a second set of markings, or scales 86, having human-readable scales, is located on the outer portion 44 of the side wall 30 of the syringe barrel 12. In this way, the detection system 18 of the present disclosure prints the identifier 80 from the human-readable scales 86 located on the outer portion 44 to the opposite side of the syringe barrel 12, for example, the inner portion 46. Such a configuration leaves the outer portion 44 of the syringe barrel 12 free from user observation, while utilizing the inner portion 46 of the syringe barrel 12 for detection and sensing functions. This configuration also provides the additional advantage of human-readable scales 86 located on the outer portion 44 of the syringe barrel 12 and accessible by a normally intended line of sight. Furthermore, in one embodiment, the identifier 80 on the syringe barrel 12 is transparent to prevent confusion for the user when reading the human-readable scale 86.

[0043] Referring to Figures 3 and 4, in another exemplary embodiment, a first set of markings, or scales 84, having an identifier 80, is located on the outer portion 44 of the side wall 30 of the syringe barrel 12, and a second set of markings, or scales 86, having human-readable scales, is located on the outer portion 44 of the side wall 30 of the syringe barrel 12. In one such embodiment, the identifier 80 may be part of the human-readable scales 86. For example, the identifier 80 may be added to each portion of the human-readable scales 86. In another such embodiment, the identifier 80 may be separated from the human-readable scales 86.

[0044] As described above, in some embodiments, the plunger rod 14 and the stopper 16 may be integrally formed as a plunger assembly. The integrally formed plunger assembly 14 includes a first end 60, a second end 62, and a plunger stopper portion, for example, a stopper 16 integrally formed with the plunger rod 14, the plunger stopper portion being slidably positioned within the interior 36 of the syringe barrel 12. The plunger stopper portion is sized for the interior 36 of the syringe barrel 12 and provides a sealed engagement with the side wall 30 of the syringe barrel 12. In such embodiments, the sensor 82 of the detection system 18 of the present disclosure is connected to a portion of the plunger assembly 14. For example, the sensor 82 may be located within a portion of the plunger assembly 14, the sensor 82 may be attached to a portion of the plunger assembly 14, or the sensor 82 may be formed as part of the plunger assembly 14. Referring to Figures 2 and 3, in some embodiments, the sensor or sensing device 82 may be connected to a portion of the plunger assembly 14 and located outside the syringe barrel 12. In such embodiments, various different configurations of the detection system 18 of the present disclosure are assumed, as described in detail above.

[0045] Referring here to Figures 1-6, the use of a syringe assembly 10 equipped with a detection system 18 of the present disclosure for filling the syringe barrel 12 with a drug from another vial before use will be described. When it is desired to draw a fluid, such as a drug, into the chamber 36 of the syringe barrel 12, with the syringe assembly 10 in the position shown in Figures 1 and 2, and the needle assembly locked to the distal end 32 of the syringe barrel 12 and positioned in communication with the fluid-containing vial, the user moves the plunger rod 14 generally in the direction along arrow A (Figure 2) until the desired amount of fluid is drawn into the chamber 36 of the syringe barrel 12. In this way, the movement of the stopper 16 via the plunger rod 14 generally in the direction along arrow A (Figure 2) creates a vacuum in the chamber 36 of the syringe barrel 12. The user moves the stopper 16 via the plunger rod 14 from the position shown in Figure 2 to the position shown in Figure 3, thereby actively increasing the volume in the chamber 36 of the syringe barrel 12. The stopper 16 is sized relative to the syringe barrel 12 to provide a sealed engagement with the inner wall 46 of the syringe barrel 12, as described above, and the needle assembly, locked to the distal end 32 of the syringe barrel 12, is placed in a vial containing fluid, so that air cannot enter the chamber 36 of the syringe barrel 12. Therefore, when the user actively increases the volume in the chamber 36, the same number of air molecules are placed in the chamber 36. This reduces the pressure inside the chamber 36 of the syringe barrel 12 compared to the air pressure outside the syringe barrel 12. Thus, a vacuum, i.e., a space of lower air pressure, is created, drawing fluids such as drugs into the chamber 36 of the syringe barrel 12.

[0046] The detection system 18 of the present disclosure allows a sensor 82 connected to a portion of the syringe assembly 10 or the plunger rod 14 to sense the movement of the plunger rod 14 relative to the syringe barrel 12 by directly reading the scales 84 having identifiers 80 as the plunger rod 14 passes each of the scales 84, each having identifiers 80, when the user moves the plunger rod 14 in a direction generally along arrow A (Figure 2) until a desired amount of fluid is drawn into the chamber 36 of the syringe barrel 12. In this way, the detection system 18 of the present disclosure provides accuracy in monitoring the amount of fluid contained in the syringe barrel, detecting the movement of the plunger in the syringe barrel, and / or detecting the position of the plunger in the syringe barrel.

[0047] The syringe assembly 10 equipped with the detection system 18 of this disclosure may also be used in pre-filled syringe assemblies and / or injectable syringe assemblies. In this way, the need for the user to fill the device before injection is eliminated, thereby saving time and maintaining a constant amount for delivery.

[0048] Referring to Figure 3, the use of a syringe assembly 10 equipped with a detection system 18 of the present disclosure for discharging a fluid, such as a drug, contained within the chamber 36 of the syringe barrel 12 will now be described. Referring to Figure 3, the fluid F is contained within the chamber 36 of the syringe barrel 12. In one embodiment, the fluid F is contained within the chamber 36 between the stopper 16 and the distal end 32 of the syringe barrel 12. The user can then attach the tip 42 of the syringe barrel 12 to a separate needle assembly or IV connection assembly and fixatively engage the needle assembly or IV connection assembly with the tip 42 of the syringe barrel 12 in a known manner. Any air trapped within the chamber 36 of the syringe barrel 12 before dispensing any drug can be discharged in a known manner.

[0049] When it is desired to discharge or deliver the drug contained in the syringe barrel 12, the syringe assembly 10 is grasped by the user's thumb on the flange 66 of the plunger rod 14 and the user's fingers extending around the flange 40 of the syringe barrel 12. In this way, the syringe assembly 10 is grasped by the user in a well-known and familiar manner. The user then performs a compressive motion between their thumb on the flange 66 of the plunger rod 14 and the four fingers grasping the flange 40 of the syringe barrel 12, thereby causing the stopper 16 to move via the plunger rod 14 in a direction generally along arrow B (Figure 3). In this way, the movement of the stopper 16 via the plunger rod 14, generally in a direction generally along arrow B, forces the fluid F contained in the chamber 36 of the syringe barrel 12 to be pushed out through the outlet opening 38. The fluid can be discharged from the syringe barrel 12 through the outlet opening 38 into a separate needle assembly or IV assembly and to the patient.

[0050] Advantageously, using the detection system 18 of the present disclosure, when the plunger rod 14 moves from a fully retracted position, as shown in Figure 3, toward the distal end 32 of the syringe barrel 12, generally in the direction along arrow B (Figure 3), the sensor 82 can determine the movement along the syringe barrel by detecting printed patterns of magnetic ink at identifiers 100, 102, 104, 106, 108, 110 (Figure 1). Furthermore, in this manner, the detection system 18 of the present disclosure also provides accuracy in monitoring the amount of fluid contained in the syringe barrel, detecting the movement of the plunger within the syringe barrel, detecting the position of the plunger within the syringe barrel, and / or monitoring the amount delivered by the syringe assembly.

[0051] In other words, the detection system 18 of the present disclosure enables the detection of the movement of the plunger rod 14 relative to the syringe barrel 12 by a sensor 82 connected to a portion of the plunger rod 14, which directly reads the scales 84 having identifiers 80 as the plunger rod 14, equipped with the sensor 82, passes each of the scales 84, each having an identifier 80, thereby enabling the detection of the volume delivered by the syringe 10.

[0052] In one exemplary embodiment, the detection system of the present disclosure integrates the addition of an additive that functions as an identifier to human-readable ink on a portion of the syringe barrel to provide accuracy in monitoring the amount of fluid contained in the syringe barrel, detecting the movement of the plunger in the syringe barrel, detecting the position of the plunger in the syringe barrel, and / or monitoring the volume received in or delivered by the syringe assembly. In another exemplary embodiment, the detection system of the present disclosure introduces an additive that functions as an identifier from the human-readable ink to the opposite side of the syringe barrel to leave the outer portion with the human-readable ink free from observation, while utilizing the inner portion with the identifier for detection and sensing capabilities.

[0053] Furthermore, the application of the detection system and syringe identification by scale detection of this disclosure may include mechanical advantages over external operation and function via a collaborative device. The ink additive serves as a feature of the method for detecting specific mechanical adaptations. The ink additive also serves as an auxiliary mechanism for sensing dosing, such that the stopper of the plunger assembly generates greater contrast when the stopper and / or plunger assembly passes each of the scales, each having an identifier. The ink additive may also include sensing-assist properties to improve function, including (1) optical, e.g., sparsely arranged arrays with optical arrays, optical scanners or linear scanners, pattern matching; (2) RF-based antennas; (3) IR / ultrasonic TOF; (4) inductive encoders or LVDTs; (5) interferometry; (6) magnetic encoders, digital image correlation, or dark-field laser tracking, as in the case of optical mice; (7) capacitive; or (8) resistive-based. Furthermore, the use of functional inks enables the printing of patterns onto syringes, providing a means of absolute position detection through the unique patterns of ink or the distance between markings, which allow for specific changes in the signal received by the sensor.

[0054] Adding magnetic particles to the syringe markings, or other optical elements, creates a greater contrast between the plunger rod and the syringe markings for enhanced observation by a sensor. Furthermore, the addition of magnetic particles to the syringe markings, or other optical elements, helps a sensor attached to the plunger rod itself to sense the movement of the plunger rod by directly reading the syringe markings as the plunger rod passes through them, thereby sensing the amount being delivered by the syringe. The sensor in the detection system can also be manufactured as part of the plunger assembly, for example, as an addition to or modification of a stopper. The type of sensor and markings can be any of a variety of techniques.

[0055] Additional applications of the ink and detection system of this disclosure may be used in other means of fluid transfer in medical settings. The ink may be added to other medical containers such as pen syringes and IV bags to track consumption. It may also be applied to diagnostic applications for sample tracking and processing, and to robotic applications for filling or transferring liquids such as pharmaceutical formulations.

[0056] Although this disclosure has been described as having exemplary designs, this disclosure may be further modified in spirit and scope. Therefore, this application is intended to cover any variation, use, or application of the disclosure using its general principles. Furthermore, this application is intended to cover any deviations from this disclosure that fall within the scope of known or customary practices in the art relating to and within the scope of the appended claims.

Claims

1. A container barrel having a first end, a second end, and side walls extending between them and defining the interior, A plurality of scales arranged on the side wall portion, wherein each of the plurality of scales includes an identifier, the identifier is formed of magnetic ink, and the weight of the line of each identifier is different from the weight of the line of each identifier of the plurality of scales, A plunger assembly having a first end, a second end, and a plunger stopper portion slidably disposed within the interior of the container barrel, wherein the plunger stopper portion is sized relative to the interior of the container barrel and provides a sealed engagement with the side wall of the container barrel. A sensor connected to the plunger assembly, wherein the sensor detects the weight of the lines of each identifier, determines the position of the plunger assembly relative to the container barrel, and the sensor includes a magnetic sensor, A fluid container assembly characterized by including the following:

2. A fluid container assembly according to claim 1, wherein the fluid container is a syringe, and the container barrel is a syringe barrel.

3. A fluid container assembly according to claim 1, wherein the sensor is disposed within the plunger assembly.

4. A fluid container assembly according to claim 1, wherein the sensor is attached to the plunger assembly.

5. A fluid container assembly according to claim 1, wherein the sensor is formed as part of the plunger assembly.

6. A fluid container assembly according to claim 1, wherein the scale is arranged on the inner portion of the side wall.

7. A fluid container assembly according to claim 6, further characterized in that the outer portion of the side wall includes a human-readable scale.

8. A fluid container assembly according to claim 1, wherein the scale is arranged on the outer portion of the side wall.

9. A fluid container assembly according to claim 8, further characterized in that the outer portion of the side wall includes a human-readable scale.

10. A fluid container assembly according to claim 9, wherein the identifier is the portion of the human-readable scale.

11. Syringe assembly, A syringe barrel having a first end, a second end, and a side wall extending between them and defining the interior, A plurality of scales arranged on the side wall portion, each of the plurality of scales including an identifier, each identifier formed with magnetic ink, and the weight of the line of each identifier being different from the weight of the respective lines of the other identifiers on the plurality of scales, A plunger rod having a first end and a second end, A stopper that engages with the second end of the plunger rod and is slidably disposed within the interior of the syringe barrel, wherein the stopper is sized relative to the interior of the syringe barrel and provides a sealing engagement with the side wall of the syringe barrel, A sensor that detects the weight of the line for each identifier and provides information regarding the position of the plunger rod relative to the syringe barrel, wherein the sensor is a magnetic sensor, A syringe assembly characterized by including the following:

12. A syringe assembly according to claim 11, wherein the sensor is disposed within the plunger rod.

13. A syringe assembly according to claim 11, wherein the sensor is attached to a plunger rod.

14. A syringe assembly according to claim 11, wherein the sensor is formed as part of the plunger rod.

15. A syringe assembly according to claim 11, wherein the sensor is disposed within the stopper.

16. A syringe assembly according to claim 11, wherein the sensor is attached to the stopper.

17. A syringe assembly according to claim 11, wherein the sensor is formed as part of the stopper.

18. A syringe assembly according to claim 11, wherein the scale is arranged on the inner portion of the side wall.

19. A syringe assembly according to claim 11, wherein the scale is arranged on the outer portion of the side wall.

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