WO2017120358A1 - Seringue à double cylindre et à soupape unique et méthode d'utilisation pour des diagnostics médicaux, utilisation thérapeutique, et confirmation de mise en place et injection dans l'espace articulaire - Google Patents

Seringue à double cylindre et à soupape unique et méthode d'utilisation pour des diagnostics médicaux, utilisation thérapeutique, et confirmation de mise en place et injection dans l'espace articulaire Download PDF

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Publication number
WO2017120358A1
WO2017120358A1 PCT/US2017/012361 US2017012361W WO2017120358A1 WO 2017120358 A1 WO2017120358 A1 WO 2017120358A1 US 2017012361 W US2017012361 W US 2017012361W WO 2017120358 A1 WO2017120358 A1 WO 2017120358A1
Authority
WO
WIPO (PCT)
Prior art keywords
barrel
hub
syringe
lumen
test indicator
Prior art date
Application number
PCT/US2017/012361
Other languages
English (en)
Inventor
Adam BENDER
Michael DOLPHIN
Original Assignee
Accuro Technologies Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Accuro Technologies Inc. filed Critical Accuro Technologies Inc.
Publication of WO2017120358A1 publication Critical patent/WO2017120358A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/19—Syringes having more than one chamber, e.g. including a manifold coupling two parallelly aligned syringes through separate channels to a common discharge assembly
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A61M2005/2403—Ampoule inserted into the ampoule holder
    • A61M2005/2407—Ampoule inserted into the ampoule holder from the rear
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/22—Valves or arrangement of valves
    • A61M39/24—Check- or non-return valves
    • A61M2039/242—Check- or non-return valves designed to open when a predetermined pressure or flow rate has been reached, e.g. check valve actuated by fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/13—General characteristics of the apparatus with means for the detection of operative contact with patient, e.g. lip sensor

Definitions

  • the present disclosure generally relates to syringes.
  • Intra-articular injections are typically administered by orthopedic surgeons, rheumatologists, and other physicians and health care professionals.
  • Intra-articular injections typically include therapeutics that assist in pain relief or treatment by administration thereof into the affected areas.
  • intra-articular injection therapeutics may be in the form of steroids.
  • steroids may have anti-inflammatory properties that can decrease inflammation of the affected joint; provide relief to patients with noninflammatory arthritis, such as osteoarthritis; or protect joint cartilage.
  • the intra-articular injection therapeutics may have properties that improve the lubrication of the joint, reduce pain, or improve range of motion.
  • the intra-articular injection therapeutics may include local anesthetic to provide a temporary analgesic affect.
  • Intra-articular injections are a complicated procedure, which requires precise positioning. A substantial portion of intra- articular injections are not effectively administered because of the complex human anatomy and precise positioning required to inject the therapeutic into the joint space. This often results in physicians and professionals using expensive, time-consuming, and complex medical imaging tools to properly administer intra-articular injection in the three-dimensional structure of a patient's joint space. Even using medical imaging tools, the physician may miss the precise location, thus failing to deliver effective treatment.
  • Such intra-articular injections may include using a delivery device, such as a syringe, for example.
  • a delivery device such as a syringe
  • Exemplary implementations of such delivery devices are shown and described in the present assignee's commonly owned U.S. Patent Application Serial No.
  • reducing the number of components in the delivery device can improve manufacturing and labor costs. Further, reducing the number of components, in particular, moving components, can avoid, limit, or mitigate cross-contamination between, for example, adjacent barrels of the syringe. Still further, reducing the number of components, in particular, moving components, can avoid, limit, or mitigate the number of parts that can malfunction and lead to cross-contamination. Consequently, new approaches to administration of intraarticular injections that reduce the number of components used in the delivery device are highly desirable. BRIEF SUMMARY
  • syringes with robust and efficient form factors enable precise placement of a needle tip and sterile administration of intra-articular injections in joint spaces.
  • the syringes can include a single slider or a single valve, which enables users, such as physicians, to effectively test for precise positioning of a needle tip in joint spaces and administer intra-articular injections in a simplified manner.
  • the various implementations of the syringes disclosed herein include a single slider that can translate between at least two positions, which can allow the user to withdraw fluids from patients to determine precise location and thereafter administer intra-articular injections.
  • the various implementations of the syringes disclosed having the single slider that moves between the withdrawal and injection configurations in response to movement of one or more plungers and which can reduce complexity as well as manufacturing and labor costs. Still further, having a syringe with a single slider can mitigate, limit, or avoid having multiple moveable parts that can malfunction and lead to cross-contamination and other types of catastrophic failure.
  • An exemplary implementation of a syringe can be summarized as including a first barrel having an interior surface that forms a first barrel lumen, a second barrel having an interior surface that forms a second barrel lumen, a hub, and a single slider.
  • the syringe can include a first plunger having a head, the head of the first plunger slideably received in the first barrel lumen for movement therein, the head of the first plunger in sealing engagement with the interior surface of the first barrel, and a second plunger having a head, the head of the second plunger slideably received in the second barrel lumen for movement therein, the head of the second plunger in sealing engagement with the interior surface of the second barrel.
  • the hub can have a first proximate port to which the first barrel is coupleable, a second proximate port to which the second barrel is coupleable, and a distal port to which a needle is coupleable.
  • the single slider can be slideably received by the hub for translation with respect thereto between at least a first position in which a fluidly communicative path between the distal port of the hub and the first barrel lumen is open and a fluidly communicative path between the distal port of the hub and the second barrel lumen is closed and a second position in which the fluidly communicative path between the distal port of the hub and the second barrel lumen is open and the fluidly communicative path between the distal port of the hub and the first barrel lumen is closed.
  • the single slider can move to the second position from the first position in response to a withdrawing movement of the second plunger in the second barrel lumen and which in the second position the single slider can block the fluidly communicative path between the distal port of the hub and the first barrel lumen.
  • the syringe can also include a bias member which is received by the hub and which biases the single slider toward the first position in which the single slider blocks the fluidly communicative path between the distal port of the hub and the second barrel lumen.
  • the syringe can also include a test indicator responsive to at least one characteristic of a bodily fluid, the test indicator positioned to be exposed to a sample of the bodily fluid drawn into the second barrel lumen.
  • a syringe can be summarized as including a first barrel having an interior surface that forms a first barrel lumen, a second barrel having an interior surface that forms a second barrel lumen, a hub, a slider member.
  • the syringe can include a first plunger having a head, the head of the first plunger slideably received in the first barrel lumen for movement therein, the head of the first plunger in sealing engagement with the interior surface of the first barrel and a second plunger having a head, the head of the second plunger slideably received in the second barrel lumen for movement therein, the head of the second plunger in sealing engagement with the interior surface of the second barrel.
  • the hub can have a port and at least one channel selectively fluidly communicatively coupleable alternatingly to the first barrel lumen and the second barrel lumen.
  • the slider member can be operatively coupled to the first and the second barrels and can include at least one passageway, with the slider member translating in response to withdrawing movement of the second plunger in the second barrel lumen between a withdrawal configuration in which at least a portion of the at least one passageway of the slider member is aligned with the at least one channel of the hub to open a fluidly communicative path from the port of the hub to the second barrel lumen and concurrently close a fluidly communicative path from the port of the hub to the first barrel lumen, and an injection configuration in which the at least one passageway is offset from the at least one channel of the hub to close the fluidly communicative path from the port of the hub to the second barrel lumen and concurrently open the fluidly communicative from the first barrel lumen to the port of the hub.
  • test indicator housing which is fluidly coupleable to a first barrel which forms a first barrel lumen, a second barrel which forms a second barrel lumen, and a needle which draws a sample of a bodily fluid in the first barrel lumen or the second barrel lumen
  • a distal port fluidly coupled to the needle
  • first proximate port fluidly coupled to the first barrel lumen
  • second proximate port fluidly coupled to the second barrel lumen
  • first recess sized and shaped to receive a test indicator.
  • the test indicator can be responsive to at least one characteristic of the bodily fluid, with the first recess positioned between the distal port and the first and the second proximate ports which first recess is in a fluidly communicative path of the sample of the bodily fluid drawn from the needle to the first barrel lumen or the second barrel lumen.
  • Figure 1 is a perspective view of a syringe, according to one implementation.
  • Figure 2 is an exploded view of the syringe of Figure 1.
  • Figure 3A is a cross-sectional view of the syringe of Figure 1 taken along lines A-A, illustrating the syringe in the withdrawal configuration.
  • Figure 3B is a detail view of the syringe of Figure 1 , illustrating a portion of a test indicator housing of the syringe of Figure 1.
  • Figure 4 is a cross-sectional view of the syringe of Figure 1 taken along lines B-B, illustrating the syringe in a pre-test configuration.
  • Figure 5 is a partial perspective view of the syringe of Figure 1 , partially illustrating a hub of the syringe in the pre-test configuration.
  • Figure 6 is a cross-sectional view of the syringe of Figure 1 taken along lines B-B, illustrating the syringe in a withdrawal configuration.
  • Figure 7 is a partial perspective view of the syringe of Figure 1 , partially illustrating the hub of the syringe in the withdrawal configuration.
  • Figure 8 is a cross-sectional view of the syringe of Figure 1 taken along lines B-B, illustrating the syringe in an injection configuration.
  • Figure 9 is a partial perspective view of the syringe of Figure 1 , partially illustrating the hub of the syringe in the injection configuration.
  • an implementation means that a particular feature, structure or characteristic described in connection with the implementation is included in at least one implementation.
  • the appearances of the phrases “in one implementation” or “in an implementation” in various places throughout this specification are not necessarily all referring to the same implementation.
  • the particular features, structures, or characteristics may be combined in any suitable manner in one or more implementations.
  • FIGS 1 through 3B illustrate a syringe 10, according to one example implementation.
  • the syringe 10 may, for example, be used to provide intra-articular injections.
  • the syringe 10 may be used to determine where a needle tip is currently positioned within a three-dimensional structure of a joint and to deliver an injectable fluid to a desired location, such as an intra-articular location.
  • the syringe 10 may be used to apply injections in an intrathecal space where fluid withdrawal may be required and precise positioning of the needle tip to deliver an injectable fluid may also be required.
  • the syringe 10 may be used to implement complex procedures where minimal movement of the syringe 10 may be required along with fluid withdrawal and delivery of an injectable fluid, such as ophthalmic injections, intracerebral injections, and otolaryngological procedures.
  • the injectable fluid may include a therapeutic agent (e.g., an Active Pharmaceutical Agent, such as corticosteroid, hyaluronic acid or a biologic).
  • the injectable fluid may include a diagnostic agent, such as X-ray-contrast preparations, radioactive isotopes, and/or dyes.
  • the injectable fluid may include a combination of a therapeutic agent and a diagnostic agent.
  • the injectable fluid may further include excipients or other pharmaceutically inactive substances formulated with the therapeutic agent and/or diagnostic agents.
  • the syringe 10 includes a withdrawal chamber barrel 12 and an injectable fluid chamber barrel 14.
  • the barrels 12, 14 each have a respective interior space or lumens 17, 19.
  • the withdrawal chamber barrel 12 and the injectable fluid chamber barrel 14 may be formed of transparent or translucent materials, such as clear plastic or glass, to allow a user to view the interior of the withdrawal chamber and injectable fluid chamber barrels 12, 14.
  • the withdrawal chamber and injectable fluid chamber barrels 12, 14 may include graduation markings to allow the user to view a fluid against the graduation markings to assess the volume of fluid in the respective chamber barrels 12, 14.
  • An upper end of the withdrawal chamber barrel 12 optionally includes a finger flange 21 that extends peripherally around the upper end of the withdrawal chamber barrel 12.
  • the finger flange 21 of the withdrawal chamber barrel 12 has a substantially circular shape.
  • the finger flange 21 may have any other shape, such as elliptical, hexagonal, square, etc. The finger flange 21 assists a user by providing a gripping surface during use.
  • An upper end of the injectable fluid chamber barrel 14 optionally includes a finger flange 23 that extends peripherally around an upper end of the injectable fluid chamber barrel 14.
  • the finger flange 23 of the injectable fluid chamber barrel 14 has a substantially elliptical shape.
  • the finger flange 23 may have any other shape, such as circular, hexagonal, square, etc.
  • the finger flange 23 also assists a user by providing a gripping surface during use.
  • the syringe 10 includes a first plunger 25 and a head or plunger seal 26 at a lower end of the first plunger 25.
  • the first plunger 25 is partially received in the withdrawal chamber lumen 17 of the withdrawal chamber barrel 12.
  • the plunger seal 26 sealingly engages with an interior surface of the withdrawal chamber barrel 12 which forms the withdrawal chamber lumen 17.
  • the first plunger 25 is slideably moveable within the withdrawal chamber barrel 12 and includes a thumb rest 27.
  • the sealing engagement of the plunger seal 26 with the interior surface of the withdrawal chamber barrel 12 creates a vacuum in the withdrawal chamber barrel lumen 17 in response to movement of the first plunger 25.
  • the vacuum created in the withdrawal chamber barrel lumen 17 facilitates creating a pressure differential to draw fluid toward the withdrawal chamber barrel lumen 17 in response to distal movement of the first plunger 25.
  • the withdrawal chamber barrel 12 can be coupled to a source of fluid, such as, for example, an intra-articular joint of a patient. Distal movement of the first plunger 25 relative to the lower end of the withdrawal chamber barrel 12 creates a negative relative pressure or vacuum in the withdrawal chamber lumen 17 to draw the fluid toward the withdrawal chamber lumen 17 from the source of fluid.
  • the plunger seal 26 may, for instance, be made from rubber or a resilient, conformable polymer, such as an elastomer.
  • the syringe 10 also includes a second plunger 30 and a head or plunger seal 31 at a lower end of the second plunger 30.
  • the second plunger 30 is partially received in the injectable fluid chamber lumen 19 of the injectable fluid chamber barrel 14.
  • the plunger seal 31 sealingly engages with an interior surface of the injectable fluid chamber barrel 14 which forms the injectable fluid chamber lumen 19.
  • the second plunger 30 is slideably moveable within the injectable fluid chamber barrel 14 and includes a thumb rest 32. The sealing engagement of the plunger seal 31 with the interior surface of the injectable fluid chamber barrel 14 creates a vacuum in the injectable fluid chamber barrel lumen 19 in response to movement of the second plunger 30.
  • the vacuum created in the injectable fluid chamber barrel lumen 19 facilitates creating a pressure differential to draw fluid in the injectable fluid chamber lumen 19 in response to distal movement of the second plunger 30.
  • the injectable fluid chamber barrel 14 can be coupled to a bottle, bolus, or other source of fluid to draw the injectable fluid, such as, for example, medicant(s) contained in the bottle.
  • the injectable fluid can be pre-loaded in the injectable fluid chamber barrel 14 prior to delivery to a user, for example, a healthcare provider.
  • the medicant(s) can include a therapeutic agent (e.g. , an Active Pharmaceutical Agent, such as corticosteroid, hyaluronic acid or a biologic).
  • the injectable fluid may include a diagnostic agent, such as X-ray-contrast preparations, radioactive isotopes, and/or dyes.
  • the injectable fluid can include a combination of a therapeutic agent and a diagnostic agent.
  • the injectable fluid may further include excipients or other pharmaceutically inactive substances formulated with the therapeutic agent and/or diagnostic agents.
  • Distal movement of the second plunger 30 relative to the lower end of the injectable fluid chamber barrel 14 creates a negative relative pressure or vacuum in the injectable fluid chamber lumen 19 to draw the fluid in the injectable fluid chamber lumen 19 from the bottle or other source of fluid.
  • proximal movement of the second plunger 30 relative to the lower end of the injectable fluid chamber barrel 14 creates a positive pressure to expel the fluid in the injectable fluid chamber barrel lumen 19.
  • the plunger seal 31 may, for instance, be made from rubber or a resilient, conformable polymer, such as an elastomer.
  • the withdrawal chamber barrel 12 and the injectable fluid chamber barrel 14 are detachably coupleable to a communal hub 34.
  • the syringe 10 includes coupling adapters 35, 36, for example, in the form of female and male Luer-Lock portions, which couple the withdrawal chamber and injectable fluid chamber barrels 12, 14 to the communal hub 34.
  • Male couplers for example, in the form of male Luer-Lock portions, are located at respective lower ends of the withdrawal chamber barrel 12 and the injectable fluid chamber barrel 14.
  • Female couplers for example, in the form of female Luer-Lock portions, are located at respective upper ends of the communal hub 34 proximal to an injectable fluid port 37 and a withdrawal chamber fluid port 39.
  • the male Luer-Lock portions are physically detachably coupleable to corresponding female Luer-Lock portions. In this manner, the withdrawal chamber barrel 12 and/or the injectable fluid chamber barrel 14 may each be selectively detachable from the syringe 10.
  • the communal hub 34 includes a first portion 42 and a second portion 44 that is coupled to the first portion 42.
  • the first portion 42 and the second portion 44 are generally L- shaped. In other implementations, however, other shapes and configurations of the first portion 42 and the second portion 44 are within the scope of the disclosed subject matter.
  • the first portion 42 includes a base flange 45 and a test indicator housing portion 46 that generally extends in a substantially perpendicular direction from the base flange 45 of the first portion 42.
  • the second portion 44 also includes a base flange 47 and a slider housing portion 48 that generally extends in a substantially perpendicular direction from the base flange 47 of the second portion 44.
  • the base flange 45 of the first portion 42 and the base flange 47 of the second portion 44 include mating surfaces that mate with each other to couple the first portion 42 to the second portion 44.
  • the syringe 10 optionally includes a seal, such as, for example, a gasket 50.
  • the gasket 50 in combination with the mating surfaces of the base flange 45 of the first portion 42 and the base flange 47 of the second portion 44 facilitate a sealing engagement between the first portion 42 and the second portion 44 to limit, avoid, or mitigate any leakage in the communal hub 34 as fluid is
  • the first portion 42 can be coupled to the second portion 44 via one or more fasteners 51 .
  • the first portion 42 and the second portion 44 can include one or more apertures sized and shaped to receive the one or more fasteners 51 that couple the first portion 42 to the second portion 44.
  • the first portion 42 and the second portion 44 can be coupled via other structures and techniques, for example, via welds, e.g., heat or ultrasonic welds.
  • the first portion 42 and the second portion 44 can be integrally formed to comprise a unitary communal hub 34.
  • the first portion 42 of the communal hub 34 includes a shaft portion 52 that extends from the test indicator housing portion 46 through a shaft aperture 53 located in the base flange 45 of the first portion 42.
  • the shaft portion 52 is generally cylindrically shaped and includes a shaft groove 54.
  • the shaft groove 54 is sized and shaped to receive a seal, such as, for example, an O-ring 57a.
  • the shaft portion 52 protrudes beyond the mating surface of the base flange 45 of the first portion 42 and is sized and shaped to be received by an aperture or a slider chamber 58 that is formed when the first portion 42 is coupled to the second portion 44.
  • the slider chamber 58 is sized and shaped to sealingly receive a slider 59.
  • the slider 59 is operatively coupled to the withdrawal chamber barrel 12 and/or the injectable fluid chamber barrel 14.
  • the slider 59 is moveable between at least a first position ( Figure 5) and a second position ( Figure 7).
  • the slider 59 operates as a switching device or valve that can form a fluidly communicative path between the communal hub 34 and the withdrawal chamber barrel 12 while blocking a fluidly communicative path between the communal hub 34 and the injectable fluid chamber barrel 14 in the first position.
  • the slider 59 can also form the fluidly communicative path between the communal hub 34 and the injectable fluid chamber barrel 14 while blocking the fluidly communicative path between the communal hub 34 and the withdrawal chamber barrel 12 in the second position. In this manner, the slider 59 switches between the first and second positions during use, for example, via distal movement of the first plunger 25 disposed in the withdrawal chamber barrel 12, to avoid manually moving or actuating a knob or lever of a valve or a similar device between different configurations.
  • the slider 59 can, in response to movement of one or both plungers, switch between the first and second positions in operation to open and close fluidly communicative paths from the communal hub 34 to or from the withdrawal chamber barrel 12 and the injectable fluid chamber barrel 14, the slider 59 can avoid the syringe requiring use of multiple valves.
  • the slider 59 has a main body 60 with a shaft chamber 61 extending at least partially through the main body 60 to define a wall 62 and a base 63.
  • the shaft chamber 61 is sized and shaped to slideably receive the shaft portion 52. In this manner, the slider 59 translates with respect to the communal hub 34 between the first position ( Figure 5) and the second position ( Figure 7). Further, as discussed above, the shaft portion 52 sealingly engages the shaft chamber 61 .
  • the shaft groove 54 in cooperation with the O-ring 57a provides a sealing engagement between the shaft portion 52 and the wall 62 of the slider 59.
  • the slider 59 further includes a plurality of spaced apart slider grooves 65.
  • the slider grooves 65 extend around a periphery of an outer surface of the wall 62.
  • the slider grooves 65 are sized and shaped to receive seal devices, such as, for example, O-rings 57b.
  • the slider grooves 65 in cooperation with the O-rings 57b provide a sealing engagement between the slider 59 and the slider chamber 58 for slideable movement of the slider 59 with respect to the shaft portion 52.
  • the main body 60 of the slider 59 further includes a slider passage 67 that extends through the wall 62 of the main body 60 to provide a fluidly communicative path to or from the communal hub 34 to the withdrawal chamber barrel 12 and injectable fluid chamber barrel 14 as discussed in more detail below.
  • a single, unitary slider 59 may be provided which is formed of a cast silicone rubber, equivalent elastomer, or other suitable materials, in lieu of having multiple components, such as a main body, O-rings, etc.
  • the syringe 10 includes a bias member 69 that is disposed in the slider chamber 58.
  • the bias member 69 generally selectively biases the slider 59 toward the first position ( Figure 5).
  • the bias member 69 may comprise a helical spring, e.g., a compression spring.
  • the syringe 10 may include other bias members, such as, for example, washers (e.g., Belleville washers), hydraulic units, pneumatic units, or other resilient members which have suitable moduli of elasticity to bias or urge the slider 59 toward the first position.
  • the bias member 69 is disposed in the slider chamber 58 and includes a first end that is coupled to an exterior surface of the test indicator housing portion 46 and a second end that is coupled to the exterior surface of the wall 62 of the slider 59.
  • the test indicator housing portion 46 of the second portion 44 of the communal hub 34 includes a test indicator housing body 73.
  • the test indicator housing body 73 includes a first recess 74 that extends partially through the test indicator housing body 73 to define a test indicator receiving region 75.
  • the test indicator receiving region 75 is sized and shaped to receive a test indicator 77.
  • the test indicator 77 typically provides a visual indication (e.g., appearance of line, change of color) when contacted by a defined substance.
  • the test indicator 77 is located in the test indicator receiving region 75 so as to be contacted by fluid drawn into the withdrawal chamber lumen 17 via operation of the first plunger 25.
  • the test indicator 77 may take the form of a test strip that is removably received in the test indicator receiving region 75.
  • the test indicator 77 shown in Figures 1 through 3B takes the form of a rectangular shaped test strip of material (e.g., lateral flow strip) with one or more substances (e.g., reagents) that react in a defined manner (e.g., change color) in the presence of defined substances (e.g., glucose).
  • the test indicator 77 includes a first test strip portion 78 and a second test strip portion 79.
  • the first test strip portion 78 may be responsive to a defined substance, such as, for example, a protein
  • the second test strip portion 79 may be responsive to another defined substance, such as, for example, glucose, or vice versa.
  • the test indicator 77 is visible from an exterior of the syringe 10 and is in sealing engagement with the communal hub 34.
  • the test indicator housing body 73 may include a second recess 80 that partially extends through the test indicator housing body 73 and which surrounds the first recess 74.
  • the second recess 80 partially extends through the test indicator housing body 73 a certain distance that is less than the distance the first recess 74 extends through the test indicator housing body 73 to define a cover receiving surface 81 and a test fluid opening 82.
  • the cover receiving surface 81 is sized and shaped to receive a cover 84 with an optional test strip seal device 85, for example, a test strip gasket, sandwiched therebetween.
  • the cover 84 can comprise transparent or translucent materials, such as clear glass, plastic, or other materials that have suitable properties to be visible from the exterior of the syringe 10.
  • the cover 84 and the test strip seal device 85 are coupleably received in the test indicator housing portion 46 and are in sealing engagement with the test indicator housing portion 46.
  • the test indicator housing portion 46 includes one or more passageways formed in the test indicator housing body 73 which form a fluidly communicative path from the communal hub 34 and ports thereof to the withdrawal chamber barrel 12.
  • the test indicator housing portion 46 includes a first passage 87 and a second passage 88 that partially extends through the test indicator housing body 73 proximal to the test indicator receiving region 75.
  • the test indicator housing body 73 also includes a first test barrel channel 89 that extends from the test indicator housing body 73 through the shaft portion 52 in a longitudinal direction of the syringe 10.
  • the first passage 87 extends from the test indicator receiving region 75 to the first test barrel channel 89 in a direction that is generally perpendicular to the
  • test fluid opening 82, the first passage 87, and the first test barrel channel 89 form, at least in part, a fluidly communicative path in the communal hub 34 to one or more ports thereof.
  • the test indicator housing portion 46 also includes a second test barrel channel 90 that extends from the test indicator housing body 73 to the withdrawal chamber fluid port 39 in the longitudinal direction of the syringe 10.
  • the second passage 88 extends from the test indicator receiving region 75 to the second test barrel channel 90 in a direction that is generally perpendicular to the longitudinal direction of the syringe 10.
  • the test fluid opening 82, the second passage 88, and the second test barrel channel 90 form, at least in part, a fluidly communicative path in the communal hub 34 to the withdrawal chamber barrel 17. More particularly, the first test barrel channel 89, the first passage 87, the test fluid opening 82, the second passage 88, and the second test barrel channel 90 cooperate to form a fluidly
  • the test fluid opening 82 is sized and shaped to limit, reduce, or restrict the volume of fluid that may be drawn from a patient during operation.
  • the reduced sectional area of the test fluid opening 82 can limit the volume of fluid drawn and provide early indication of the reaction of the fluid with the test indicator 77 in the specifically defined manner.
  • the communal hub 34 includes one or more ports.
  • a lower portion of the communal hub 34 includes one or more needle ports 91 through which a needle 92 is coupled to the communal hub 34.
  • the one or more needle ports 91 may be formed by or part of a Luer-Lock connector or coupler.
  • the needle port 91 may be part of a male Luer-Lock portion and the needle 92 may include a female Luer-Lock portion that detachably rotatingly couples with the male Luer-Lock portion. While the implementation illustrated in Figures 1 through 3B includes a Luer-Lock connection, in other
  • the communal hub 34 may include a slip-tip, an eccentric tip, or other types of needle adapters to couple the communal hub 34 to the needle 92.
  • the needle 92 includes a needle hub 93 and a needle shaft 94.
  • the needle shaft 94 includes a beveled end or point or tip 95, and includes a lumen extending therethrough.
  • the needle 92 is fluidly communicatively coupled to the syringe 10 to withdraw or expel fluid when administering to a patient.
  • the syringe 10 is operable in at least three configurations, namely, pre-test configuration, withdrawal configuration, and injection configuration.
  • Figures 4 and 5 illustrate the syringe 10 in the pre-test configuration.
  • Figure 5, more specifically, illustrates a partial perspective view of the communal hub 34 with certain components removed for clarity.
  • the injectable fluid chamber barrel 14 includes a fluid, such as the medicant(s) discussed above, in the injectable fluid chamber lumen 19.
  • a user may withdraw the second plunger 30 to draw fluid, e.g., medicant(s), from a bottle, bolus, or other source of fluid to receive the fluid in the injectable fluid chamber lumen 19.
  • the user may directly inject the fluid, e.g., medicant(s), to a patient when the syringe 10 is in the pre-test
  • the slider 59 disposed in the slider chamber 58 is in the first position.
  • the bias member 69 e.g., the spring is positioned to apply a biasing force so that the slider 59 is biased or urged to the first position.
  • a wall 100 of the slider housing portion 48 of the second portion 44 blocks the slider passage 67 to block the fluidly
  • the second portion 44 of the communal hub 34 includes a groove that defines an injection barrel passage 101 which extends from the injectable fluid port 37 to the slider chamber 58.
  • the slider housing portion 48 of the second portion 44 also includes fluid passageway 102 that extends through the wall 100 of the slider housing portion 48 to the slider chamber 58.
  • the injectable fluid port 37, the injection barrel passage 101 , and the fluid passageway 102 cooperate to form a fluidly communicative path from the injectable fluid barrel lumen 19 to the needle port 91 when the slider 59 is in the first position, while the slider 59 concurrently blocks a fluidly communicative path from the withdrawal chamber barrel lumen 17 to the needle port 91 as the slider passage 67 is blocked.
  • a user in some implementations may optionally inject the fluid, e.g., medicant(s), contained in the injectable fluid barrel lumen 19 to a user when the syringe 10 is in the pre-test configuration.
  • Figures 6 and 7 illustrate the syringe 10 in the testing, withdrawing, or withdrawal configuration.
  • Figure 7, more specifically, illustrates a partial perspective view of the communal hub 34 with certain components removed for clarity.
  • the withdrawal chamber barrel 12 may contain a fluid, which is known to be found in joint spaces.
  • joints of a body include bursae, which are filled with synovial fluid.
  • Synovial fluids have a high concentration of glucose that provides essential nutrition to the synovium.
  • the user may withdraw the first plunger 25 to withdraw fluid, e.g., fluid found in joint spaces, and receive at least some of such fluid in the withdrawal chamber barrel lumen 17.
  • fluid e.g., fluid found in joint spaces
  • other applications such as, for example, injections into an intrathecal space, ophthalmic injections, intracerebral injections, and otolaryngological procedures are also within the scope of the disclosed subject matter.
  • the pressure differential created in the withdrawal chamber barrel lumen 17 and the communal hub 34— in particular, the negative relative pressure or vacuum in the withdrawal chamber barrel lumen 17— causes the slider 59 to translate from the first position to the second position in the slider chamber 58 and draw the fluid from a patient, e.g., fluid known to be found in joint spaces.
  • the slider 59 moves from the first position to the second position relative to the shaft portion 52.
  • a fluidly communicative path indicated by reference numeral 103 is open from the needle port 91 to the withdrawal chamber barrel lumen 17 while a fluidly communicative path from the needle port 91 to the injectable fluid barrel lumen 19 is blocked.
  • the slider passage 67 is at least partially aligned with the fluid passageway 102 to allow the fluid to flow therethrough and into the first test barrel channel 89, and thereafter to the test indicator housing portion 46 for testing of the fluid.
  • the testing may be for synovial fluids that may react in a defined manner when in contact with the test indicator 77.
  • the injection barrel passage 101 is blocked by the wall 62 of the slider 59 to prevent, block, or restrict expulsion of the fluid, e.g., medicant(s), contained in the injectable fluid chamber lumen 19.
  • the bias member 69 overcomes the initial biasing force of the bias member 69.
  • the bias member 69 is sized (e.g., via a spring constant of a spring) to exert a bias force that is larger than a drag force of the plunger seal 26 of the withdrawal chamber barrel 12.
  • the biasing force of the bias member 69 causes the slider 59 to return to the first position ( Figure 5).
  • Figure 9 more specifically, illustrates a partial perspective view of the communal hub 34 with certain components removed for clarity.
  • the second plunger 30 is depressed to expel fluid, e.g., medicant(s), from the injectable fluid chamber lumen 19 to the patient.
  • the slider 59 disposed in the slider chamber 58 is in the first position.
  • the wall 100 of the slider housing portion 48 of the second portion 44 blocks the slider passage 67 to block the fluidly
  • the injection barrel passage 101 which extends from the injectable fluid port 37 to the slider chamber 58, and the fluid passageway 102 cooperate to form a fluidly communicative path from the injectable fluid barrel lumen 19 to the needle port 91 , as indicated by reference numeral 104.
  • the fluidly communicative path from the injectable fluid chamber barrel lumen 19 to the needle port 91 is open while the fluidly communicative path from the needle port 91 to the withdrawal chamber barrel 17 is blocked because the slider passage 67 is not aligned with the fluid passageway 102.
  • the user may inject the fluid, e.g., medicant(s), contained in the injectable fluid barrel lumen 19 to the patient when the syringe 10 is in the injection configuration.
  • the user may initially fill the injectable fluid chamber lumen 19 with fluid, e.g., medicant(s), from a bottle or other source of medicant(s).
  • fluid e.g., medicant(s)
  • the user may then withdraw fluid from the affected joints.
  • the user may insert the tip 95 of the needle 92 at the affected joints.
  • Distal movement of the first plunger 25 creates negative relative pressure or vacuum in the withdrawal chamber barrel 12 allowing the user to withdraw fluid from the patient's joint space and moving the slider 59 from the first position to the second position to open the fluidly communicative path from the needle port 91 to the withdrawal chamber barrel lumen 17.
  • the test indicator 77 is positioned in the test indicator housing portion 46 of the communal hub 34, the withdrawn fluid may not reach the withdrawal chamber barrel lumen 17.
  • a chemical reaction between the fluid and a substance (e.g., reagent) carried by the test indicator 77 may provide an indication (e.g., visually perceptible change) of the presence of fluids which are known to be found in joint spaces, such as, for example, bursae, which are filled with synovial fluid.
  • a substance e.g., reagent
  • synovial fluids have a high concentration of glucose that provides essential nutrition to the synovium.
  • the test indicator 77 may comprise a reagent strip or other strips which use glucose oxidase, hexokinase, or cupric sulfate, for example, to determine the glucose content or presence.
  • the test indicator 77 may indicate presence of glucose colorimetrically, which may be read visually or in some implementations through a reflectance photometer.
  • the user may, for example, release the force applied to the first plunger 25 to cease creating the vacuum effect in the withdrawal chamber barrel lumen 17.
  • the biasing force of the bias member 69 urges the bias member 69 to return to the first position.
  • the user may then precisely apply the injectable fluid (e.g., an Active Pharmaceutical Agent, such as corticosteroid, hyaluronic acid or a biologic), by proximally moving or depressing the second plunger 30, which will create a positive pressure in the injectable fluid chamber barrel 14, thus expelling the injectable fluid into the joint via the tip 95 of the needle 92.
  • the injectable fluid e.g., an Active Pharmaceutical Agent, such as corticosteroid, hyaluronic acid or a biologic
  • kits may, for example, include a communal hub with a test indicator.
  • the test indicator may include a material with one or more substances (e.g., reagents) that react in a defined manner (e.g., change color) in the presence of defined substances.
  • the communal hub may include a mechanism, such as, for example, the various implementations of the slider and bias members described herein, that are operable to
  • the communal hub may include adapters such that the communal hub is coupleable to a needle and chamber barrels.
  • the kit may also include withdrawal chamber and injectable fluid chamber barrels to precisely confirm and administer injectable fluids to the affected areas. Alternatively, the kit may only include a communal hub, test indicator, and a withdrawal chamber barrel.
  • the injectable fluid barrel may be supplied by the user.
  • the kit may also include injectable fluids or medicant(s) that are being administered at the affected areas and needles.
  • the kit may also include a set of instructions for effective use of the syringe.
  • a method to use the various implementations of the syringes described herein may include filling an injectable fluid chamber lumen of an injectable fluid chamber barrel with a medicant(s).
  • the injectable fluid chamber barrel may then be coupled to a communal hub, according to one or more implementations of the communal hubs described herein, via coupling adapters, for example, Luer Locks.
  • the method may include coupling an empty withdrawal chamber barrel to the communal hub via coupling adapters, for example, Luer Locks.
  • a plunger of the withdrawal chamber barrel may be in a fully or at least partially depressed position.
  • the method may include coupling a needle to the communal hub via, for example, Luer Locks.
  • the method may further include inserting a needle into bodily tissue of a patient, for example, at intra-articular locations.
  • the method may include withdrawing the plunger of the withdrawal chamber barrel to draw fluid from the patient, for example, synovial fluid, so the fluid is drawn into a chamber disposed in the communal hub that houses a test indicator.
  • the operator of the syringe may wait to observe if the test indicator responds in a defined manner. In some implementations, if no response is observed the operator may remove and discard the withdrawal chamber barrel and couple another withdrawal chamber barrel. In some implementations, the operator may continue manipulating the syringe until a response of the test indicator is observed.
  • the operator may depress the plunger of the injectable fluid chamber barrel to inject the medicant(s).
  • the method may further include removing the syringe from the patient. In some implementations, the removed syringe may be discarded or disposed.

Landscapes

  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L'invention concerne une seringue possédant un moyeu doté d'un orifice, un premier et un second cylindre présentant des surfaces intérieures pour former des lumières respectives, une glissière unique, un indicateur de test, et un élément de sollicitation. Les premier et second cylindres reçoivent de façon coulissante des premier et deuxième pistons respectifs de manière que ces derniers se déplacent dans ceux-ci. La glissière unique est opérationnelle pour former une voie de communication fluidique entre l'orifice du moyeu et les lumières des premier et second cylindres. L'indicateur de test est réactif à au moins une caractéristique d'un fluide corporel, l'indicateur de test étant positionné de manière à être exposé à un fluide corporel quelconque aspiré dans la lumière du premier cylindre et visible depuis l'extérieur du premier cylindre.
PCT/US2017/012361 2016-01-06 2017-01-05 Seringue à double cylindre et à soupape unique et méthode d'utilisation pour des diagnostics médicaux, utilisation thérapeutique, et confirmation de mise en place et injection dans l'espace articulaire WO2017120358A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201662275422P 2016-01-06 2016-01-06
US62/275,422 2016-01-06

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WO2017120358A1 true WO2017120358A1 (fr) 2017-07-13

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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2017184755A1 (fr) * 2016-04-22 2017-10-26 Accuro Technologies Inc. Seringue à double cylindre et à coulisseau unique et procédé d'utilisation pour des diagnostics médicaux, utilisation thérapeutique, et confirmation de mise en place et injection dans l'espace articulaire
CN113518630A (zh) * 2018-12-28 2021-10-19 爱思帕全球制造有限公司 用于指示处理的物品、系统和方法
WO2021209721A1 (fr) * 2020-04-15 2021-10-21 Syrengy Seringue d'injection
WO2024046764A1 (fr) * 2022-08-31 2024-03-07 Shl Medical Ag Ensemble d'administration sélective de médicament à activation fluidique

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007149980A2 (fr) * 2006-06-21 2007-12-27 C K Dalebout Enterprise Llc SystÈmes, procÉdÉs et dispositifs pour Échantillonner un fluide corporel
US20150112248A1 (en) * 2013-10-21 2015-04-23 Accuro Technologies Inc. Double barrel syringe and method to use same for placement confirmation and joint space injection

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007149980A2 (fr) * 2006-06-21 2007-12-27 C K Dalebout Enterprise Llc SystÈmes, procÉdÉs et dispositifs pour Échantillonner un fluide corporel
US20150112248A1 (en) * 2013-10-21 2015-04-23 Accuro Technologies Inc. Double barrel syringe and method to use same for placement confirmation and joint space injection

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2017184755A1 (fr) * 2016-04-22 2017-10-26 Accuro Technologies Inc. Seringue à double cylindre et à coulisseau unique et procédé d'utilisation pour des diagnostics médicaux, utilisation thérapeutique, et confirmation de mise en place et injection dans l'espace articulaire
US10328212B2 (en) 2016-04-22 2019-06-25 Accuro Technologies Inc. Single slider double barrel syringe and method to use same for medical diagnostics, therapeutic use, and placement confirmation and joint space injection
CN113518630A (zh) * 2018-12-28 2021-10-19 爱思帕全球制造有限公司 用于指示处理的物品、系统和方法
CN113518630B (zh) * 2018-12-28 2024-01-26 爱思帕全球制造有限公司 用于指示处理的物品、系统和方法
WO2021209721A1 (fr) * 2020-04-15 2021-10-21 Syrengy Seringue d'injection
WO2024046764A1 (fr) * 2022-08-31 2024-03-07 Shl Medical Ag Ensemble d'administration sélective de médicament à activation fluidique

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