Features for angiography syringe
Patent Information
- Authority / Receiving Office
- KR · KR
- Patent Type
- Patents
- Current Assignee / Owner
- Filing Date
- 2021-08-10
- Publication Date
- 2026-08-12
Smart Images

Figure R1020247037829_ABST
Abstract
Description
Technology Field
[0001] Cross-reference regarding related applications
[0002] This application claims the benefit of U.S. Provisional Application No. 62 / 706,340 filed August 11, 2020 and U.S. Provisional Application No. 63 / 073,519 filed September 2, 2020, the full contents of which are incorporated herein by reference.
[0003] Technology field
[0004] The present disclosure relates generally to features associated with angiographic syringes. The described features provide strength to the distal end, prevent fluid leakage from the tip, improve ease of use, and improve the visualization process. Background Technology
[0005] Syringe injection systems have been one of the medical devices used in medical imaging procedures for many years. Many of these syringes are operated manually by advancing a plunger extension, which is actuated to an internal plunger, to pressurize the fluid within the syringe. However, in numerous medical injection procedures, precise control and / or high pressure may be employed that cannot be achieved through manual syringe operation. Accordingly, numerous syringes and motorized injectors have been developed for use in medical procedures such as angiography (CV), computed tomography (CT), and nuclear magnetic resonance (NMR) / magnetic resonance imaging (MRI). For example, U.S. Patent No. 5,383,858 discloses a front-loading syringe and a motorized injector in both pressure-jacketed and jacketless configurations, the details of which are incorporated herein by reference.
[0006] In certain fluid injectors, such as high-pressure fluid injectors that include a pressure jacket surrounding the syringe body to prevent syringe expansion and / or failure under high injection pressure, mounting the syringe to the fluid injector may involve multiple steps to accurately engage the syringe with the fluid injector and the pressure jacket. For example, some pressure jackets cover a large portion of the distal end of the syringe to prevent failure of the distal end under high injection pressure. This can complicate loading the syringe into the pressure jacket and subsequent engagement with the fluid injector. Similarly, the presence of a pressure jacket around the barrel and the distal end of the syringe can make it difficult to visualize the syringe and its contents, for example, to ensure that the liquid has been loaded into the syringe and that no air bubbles are present in the liquid.
[0007] When the syringe is engaged with the fluid injector, to load contrast fluid or saline into the syringe, the user typically connects the filling tube or spike to the syringe's front nozzle or discharge outlet and positions the other end of the tube / spike in fluid communication with a bottle or bag of contrast medium, saline, or other fluid. The syringe plunger is retracted (typically by the injector piston) to draw fluid into the syringe until the desired amount is loaded. After the syringe is filled, the filling tube is removed from the syringe tip. Often, a small amount of contrast or other fluid, such as saline, contained in the filling tube may drip down to the bottom or onto the injector. Fluid dripping may also occur in a multi-patient setup, where the first part of the syringe and tubing may be used over multiple infusion procedures and the second part may be discarded after a single use and replaced with a new single-use part before subsequent infusion procedures. Such fluid dripping can contaminate and dirty various injector components, cause danger to technicians and patients by dripping onto the floor, and / or contaminate various surfaces within the fluid injection product family, so it must be minimized and avoided.
[0008] After filling the syringe with liquid, a connector tube or priming tube is connected to the syringe's discharge outlet, and the syringe and connector tube are primed (typically by advancing the syringe plunger) to release air from the syringe and connector tube (i.e., to prevent air from being injected into the patient). While this technique can be effective for purging air from the piping connected to the syringe, fluid discharge from the tube ends is undesirable. Often, fluid discharged from the tube ends contaminates the outer surfaces of the piping, syringe, and / or injector, or drips or leaks from various connections onto the floor. This is particularly undesirable when handling contrast media, as the media is very viscous and tends to migrate to any surface touched by the operator after the tube has been purged.
[0009] Furthermore, in some applications, a vented spike is positioned directly on the top of the syringe. The vented spike is used to penetrate a vial of contrast fluid or saline fluid to be delivered to the patient. In these applications, if the vial and spike are removed from the syringe, fluid remaining on the spike may drip onto the syringe tip.
[0010] A syringe and improved features for use in contrast-enhanced imaging procedures are desired that easily engage with an injector, allow for easy visualization and characterization of the syringe filling status, and reduce the effects of contrast contamination and fluid dripping. means of solving the problem
[0011] The present disclosure provides a syringe suitable for use in powered fluid injection in contrast-enhanced imaging procedures such as computed tomography (CT), angiography (CV), and magnetic resonance imaging (MRI), comprising, as described herein, a feature that reduces the effect of fluid drop and further comprising other features that improve syringe capability.
[0012] According to one exemplary and non-limiting embodiment, the syringe comprises a proximal end, a distal end, and a cylindrical sidewall extending between the proximal end and the distal end—the distal end comprises a conical distal end wall and a fluid nozzle at the distal end of the conical distal end wall—; a cylindrical load-bearing wall extending axially from the cylindrical sidewall through the proximal end of the conical distal end wall; and a plurality of radial ribs positioned around the periphery of the conical distal end wall, wherein the longitudinal axis of the plurality of radial ribs extends radially inward from the cylindrical load-bearing wall toward the fluid nozzle over at least a portion of the conical distal end wall.
[0013] According to one exemplary and non-limiting embodiment, a plurality of radial ribs may define a plurality of fluid-retaining channels between adjacent radial ribs of each pair, and the plurality of fluid-retaining channels are configured to maintain a volume of liquid by capillary aggregation when the syringe is rotated from a first upward facing position to a second downward facing position. The plurality of fluid-retaining channels may be configured to maintain a liquid volume in the range of 0.1 to 0.8 milliliters. The volume of liquid maintained by the plurality of fluid-retaining channels may be determined at least partially from the distance between each adjacent pair of radial ribs, the height of each adjacent pair of radial ribs, and the distance to which each pair of radial ribs extends distally inwardly from the conical distal end wall. The plurality of radial ribs may increase the load strength of the conical distal end wall. The plurality of radial ribs may increase the load strength of the cylindrical load-bearing wall. At least one of the plurality of radial ribs may extend inwardly from the cylindrical load-bearing wall by a different radial distance across the conical distal end wall than the remaining radial ribs of the plurality of radial ribs. The cylindrical load-bearing wall may be configured to abut the retaining surface of the fluid injector's retaining arm to hold the syringe within the pressure jacket during a pressurized injection procedure. The cylindrical load-bearing wall may extend axially from the cylindrical sidewall of the syringe at an angle of 1 to 30 degrees with respect to the longitudinal axis of the syringe. The distal surface of the cylindrical load-bearing wall may be radially angled from a more proximal inner portion to a more distal outer portion with respect to the longitudinal axis of the syringe. The angle of the distal surface of the cylindrical load-bearing wall may be configured to prevent fluid entry between the cylindrical sidewall of the syringe and the pressure jacket in which the syringe is placed. The angle of the distal surface of the cylindrical load-bearing wall may be configured to increase the radially inward force on the retaining arm of the fluid injector.At least one of the cylindrical load-bearing wall and the plurality of radial ribs can enhance the refractive halo effect of electromagnetic radiation emitted from at least one electromagnetic radiation source in the piston or plunger head of the fluid injector at the distal portion of the conical distal end wall. The neck may be associated with a fluid nozzle at the distal end of the syringe, and the neck includes a fluid passage having a plurality of fluid diversion ribs extending at least partially radially inward from the inner surface of the neck into the fluid passage. The plurality of fluid diversion ribs may be configured to divert fluid flowing through the neck into the syringe so that the fluid flows along the inner surface of the conical distal end wall and the cylindrical side wall of the syringe. The plurality of fluid diversion ribs may be configured to minimize the amount of bubbles in the fluid within the syringe. The amount of bubbles in the fluid within the syringe may be minimized by the fluid flowing along the inner surface of the distal end wall and the cylindrical side wall of the syringe. At least some of the plurality of fluid diversion ribs may have different profiles. At least some of the plurality of flow diversion ribs may extend from the inner surface to the fluid passage at different distances. The plurality of radial ribs may extend along the conical distal end wall at a certain angle with respect to the longitudinal axis of the syringe such that the distance between each adjacent pair of the plurality of radial ribs tapers from the cylindrical load-bearing wall to the fluid nozzle.
[0014] According to one exemplary and non-limiting embodiment, the syringe comprises a proximal end, a distal end, and a cylindrical sidewall extending between the proximal end and the distal end—the distal end comprises a conical distal end wall and a fluid nozzle located at the distal end of the conical distal end wall—; a plurality of fluid diversion ribs extending inward from the inner surface of the fluid nozzle; and a plurality of radial ribs positioned around the periphery of the conical distal end wall, wherein the longitudinal axis of the plurality of radial ribs extends radially inward from the cylindrical load-bearing wall toward the fluid nozzle across at least a portion of the conical distal end wall.
[0015] According to one exemplary and non-limiting embodiment, a cylindrical load-bearing wall may extend axially from a cylindrical sidewall through the proximal end of a conical distal end wall. A plurality of radial ribs may define a plurality of fluid-retaining channels between adjacent pairs of radial ribs, and the plurality of fluid-retaining channels are configured to maintain a volume of liquid by capillary aggregation when a syringe is rotated from a first upward facing position to a second downward facing position. The plurality of fluid-retaining channels may be configured to maintain a liquid volume in the range of 0.1 to 0.8 milliliters. The volume of liquid maintained by the plurality of fluid-retaining channels may be determined at least partially from the distance between each adjacent pair of radial ribs, the height of each adjacent pair of radial ribs, and the distance at which each pair of radial ribs extends distally inwardly from the conical distal end wall.
[0016] According to one exemplary and non-limiting embodiment, the syringe comprises a proximal end, a distal end, and a cylindrical sidewall extending between the proximal end and the distal end—the distal end comprises a conical distal end wall and a fluid nozzle at the distal end of the conical distal end wall—and a plurality of fluid diversion ribs extending inwardly from the inner surface of the fluid nozzle, wherein the plurality of fluid diversion ribs enhance the refractive halo effect of electromagnetic radiation emitted from at least one electromagnetic radiation source in the piston or plunger head of the fluid injector at the distal portion of the conical distal end wall.
[0017] According to one exemplary and non-limiting embodiment, a cylindrical load-bearing wall may extend axially from a cylindrical side wall through a proximal end of a conical distal end wall. A plurality of radial ribs may be positioned around the periphery of the conical distal end wall, and the longitudinal axis of the plurality of radial ribs extends radially inward toward a fluid nozzle from the cylindrical load-bearing wall across at least a portion of the conical distal end wall. The plurality of radial ribs may define a plurality of fluid-retaining channels between each pair of adjacent radial ribs, and the plurality of fluid-retaining channels are configured to maintain a volume of liquid by capillary aggregation when the syringe is rotated from a first upward facing position to a second downward facing position. The plurality of fluid-retaining channels may be configured to maintain a liquid volume in the range of 0.1 to 0.8 milliliters. The volume of liquid maintained by a plurality of fluid-holding channels can be determined at least partially from the distance between each adjacent pair of a plurality of radial ribs, the height of each adjacent pair of a plurality of radial ribs, and the distance at which each pair of radial ribs extends radially inwardly and distally from the conical distal end wall.
[0018] In one embodiment, a syringe having improved features according to the following clause is provided.
[0019] Clause 1: A syringe comprising a proximal end, a distal end, and a cylindrical sidewall extending between the proximal end and the distal end—the distal end comprises a conical distal end wall and a fluid nozzle at the distal end of the conical distal end wall—; a cylindrical load-bearing wall extending axially from the cylindrical sidewall through the proximal end of the conical distal end wall; and a plurality of radial ribs positioned around the periphery of the conical distal end wall, wherein the longitudinal axis of the plurality of radial ribs extends radially inward from the cylindrical load-bearing wall toward the fluid nozzle across at least a portion of the conical distal end wall.
[0020] Clause 2: A syringe according to Clause 1, wherein a plurality of radial ribs define a plurality of fluid-retaining channels between adjacent radial ribs of each pair, and the plurality of fluid-retaining channels are configured to maintain the volume of liquid by capillary aggregation when the syringe is rotated from a first upward facing position to a second downward facing position.
[0021] Clause 3: A syringe according to Clause 2, wherein a plurality of fluid-holding channels are configured to maintain a liquid volume in the range of 0.1 to 0.8 milliliters.
[0022] Clause 4: A syringe according to Clause 2, wherein the volume of liquid retained by a plurality of fluid-holding channels is determined at least partially from the distance between each adjacent pair of a plurality of radial ribs, the height of each adjacent pair of a plurality of radial ribs, and the distance at which each pair of radial ribs extends distally inwardly from the conical distal end wall.
[0023] Clause 5: A syringe according to any one of Clauses 1 through 4, wherein a plurality of radial ribs increase the load strength of the conical distal end wall.
[0024] Clause 6: A syringe, wherein, in any one of Clauses 1 through 5, a plurality of radial ribs increase the load strength of a cylindrical load-bearing wall.
[0025] Clause 7: A syringe according to any one of Clauses 1 through 6, wherein at least one of the plurality of radial ribs extends inwardly from a cylindrical load-bearing wall by a different radial distance over a conical distal end wall than the remaining radial ribs of the plurality of radial ribs.
[0026] Clause 8: A syringe, wherein, in any one of Clauses 1 through 7, the cylindrical load-bearing wall is configured to abut the retaining surface of the retaining arm of the fluid injector to retain the syringe within the pressure jacket during a pressurized injection procedure.
[0027] Clause 9: A syringe according to any one of Clauses 1 through 8, wherein the cylindrical load-bearing wall extends axially from the cylindrical side wall of the syringe at an angle of 1 to 30 degrees with respect to the longitudinal axis of the syringe.
[0028] Clause 10: A syringe according to any one of Clauses 1 through 9, wherein the distal surface of the cylindrical load-bearing wall is radially angled from a more proximal inner portion to a more distal outer portion with respect to the longitudinal axis of the syringe.
[0029] Clause 11: A syringe in which, in Clause 10, the angle of the distal surface of the cylindrical load-bearing wall is configured to prevent fluid from entering between the cylindrical side wall of the syringe and the pressure jacket in which the syringe is placed.
[0030] Clause 12: A syringe in which, in Clause 10 or 11, the angle of the distal surface of the cylindrical load-bearing wall is configured to increase the radial inward force on the retaining arm of the fluid injector.
[0031] Clause 13: A syringe according to any one of Clauses 1 to 12, wherein at least one of the cylindrical load-bearing wall and a plurality of radial ribs enhances the refractive halo effect of electromagnetic radiation emitted from at least one electromagnetic radiation source in the piston or plunger head of the fluid injector at the distal portion of the conical distal end wall.
[0032] Clause 14: A syringe according to any one of Clauses 1 through 13, further comprising a neck portion associated with a fluid nozzle at the distal end of the syringe, wherein the neck portion comprises a fluid passage having a plurality of fluid diversion ribs extending at least partially radially inward from the inner surface of the neck portion into the fluid passage.
[0033] Clause 15: In Clause 14, a plurality of fluid diversion ribs are configured to divert fluid flowing through the neck to the syringe so that the fluid flows along the inner surface of the conical distal end wall and the cylindrical side wall of the syringe.
[0034] Clause 16: A syringe according to Clause 14 or 15, wherein a plurality of fluid diversion ribs are configured to minimize the amount of air bubbles in the fluid within the syringe.
[0035] Clause 17: A syringe in which, in Clause 16, the amount of fluid bubbles within the syringe is minimized by the fluid flowing along the inner surface of the distal end wall and the cylindrical side wall of the syringe.
[0036] Clause 18: A syringe according to any one of Clauses 14 through 17, wherein at least some of the plurality of fluid switching ribs have different profiles.
[0037] Clause 19: A syringe according to any one of Clauses 14 through 18, wherein at least a portion of a plurality of flow diversion ribs extends from an inner surface into a fluid passage at different distances.
[0038] Clause 20: A syringe according to any one of Clauses 1 through 19, wherein a plurality of radial ribs extend along a conical distal end wall at a constant angle with respect to the longitudinal axis of the syringe such that the distance between each adjacent pair of the plurality of radial ribs tapers from a cylindrical load-bearing wall to a fluid nozzle.
[0039] Clause 21: A syringe comprising a proximal end, a distal end, and a cylindrical sidewall extending between the proximal end and the distal end—the distal end comprises a conical distal end wall and a fluid nozzle at the distal end of the conical distal end wall—; a plurality of fluid diversion ribs extending inwardly from the inner surface of the fluid nozzle; and a plurality of radial ribs positioned around the periphery of the conical distal end wall, wherein the longitudinal axis of the plurality of radial ribs extends radially inwardly toward the fluid nozzle from the cylindrical load-bearing wall across at least a portion of the conical distal end wall.
[0040] Clause 22: The syringe of Clause 21, further comprising a cylindrical load-bearing wall extending axially from a cylindrical side wall through a proximal end of a conical distal end wall.
[0041] Clause 23: A syringe according to Clause 21 or 22, wherein a plurality of radial ribs define a plurality of fluid-retaining channels between adjacent radial ribs of each pair, and the plurality of fluid-retaining channels are configured to maintain the volume of liquid by capillary aggregation when the syringe is rotated from a first upward facing position to a second downward facing position.
[0042] Clause 24: A syringe according to Clause 23, wherein a plurality of fluid-holding channels are configured to hold a liquid volume in the range of 0.1 to 0.8 milliliters.
[0043] Clause 25: A syringe according to Clause 23, wherein the volume of liquid retained by a plurality of fluid-retaining channels is determined at least partially from the distance between each adjacent pair of a plurality of radial ribs, the height of each adjacent pair of a plurality of radial ribs, and the distance to which each pair of radial ribs extends distally inwardly from the conical distal end wall.
[0044] Clause 26: A syringe comprising a proximal end, a distal end, and a cylindrical sidewall extending between the proximal end and the distal end—the distal end comprises a conical distal end wall and a fluid nozzle at the distal end of the conical distal end wall—; and a plurality of fluid diversion ribs extending inwardly from the inner surface of the fluid nozzle, wherein the plurality of fluid diversion ribs enhance a refractive halo effect of electromagnetic radiation emitted from at least one electromagnetic radiation source in the piston or plunger head of the fluid injector at the distal portion of the conical distal end wall.
[0045] Clause 27: A syringe according to Clause 26, further comprising a cylindrical load-bearing wall extending axially from a cylindrical side wall through the proximal end of a conical distal end wall.
[0046] Clause 28: A syringe according to Clause 26 or 27, further comprising a plurality of radial ribs positioned around the periphery of the conical distal end wall, wherein the longitudinal axis of the plurality of radial ribs extends radially inward toward a fluid nozzle from a cylindrical load-bearing wall over at least a portion of the conical distal end wall.
[0047] Clause 29: A syringe according to Clause 28, wherein a plurality of radial ribs define a plurality of fluid-retaining channels between adjacent radial ribs of each pair, and the plurality of fluid-retaining channels are configured to maintain the volume of liquid by capillary aggregation when the syringe is rotated from a first upward facing position to a second downward facing position.
[0048] Clause 30: A syringe according to Clause 29, wherein a plurality of fluid-holding channels are configured to hold a liquid volume in the range of 0.1 to 0.8 milliliters.
[0049] Clause 31: A syringe according to Clause 29, wherein the volume of liquid retained by a plurality of fluid-retaining channels is determined at least partially from the distance between each adjacent pair of a plurality of radial ribs, the height of each adjacent pair of a plurality of radial ribs, and the distance to which each pair of radial ribs extends distally inwardly from the conical distal end wall.
[0050] As the foregoing is a summary, it may contain simplifications, generalizations, inclusions, and / or omissions of details. Consequently, those skilled in the art will understand that the summary is merely illustrative and is not intended to be limiting in any way. Other aspects, features, and benefits of the device, and / or process, and / or other subjects described herein will become apparent from the teachings set forth in this specification. In addition to the exemplary aspects and features foregoing, further aspects and features will become apparent with reference to the drawings and the following detailed description. Brief explanation of the drawing
[0051] The novel features described in this specification are particularly set forth in the appended claims. However, these features, both in their configuration and method of operation, may be better understood by referring to the following description taken together with the accompanying drawings. FIG. 1 is a perspective view of a syringe according to one example of the present disclosure. Figure 2 is a side view of the syringe of Figure 1. Figure 3 is a cross-sectional view of the syringe of Figure 1 along line AA. Figure 4 is a plan view of the syringe of Figure 1. FIG. 5 is a perspective view of a syringe according to another example of the present disclosure. FIG. 6 is a perspective view of a syringe according to another example of the present disclosure. FIG. 7a is a cross-sectional view of a syringe held in a holding device according to one example of the present disclosure. FIG. 7b is a cross-sectional view of the syringe of FIG. 7a inserted into the retaining device. FIG. 8 is a side view of a syringe according to one example of the present disclosure. Fig. 9 is an enlarged side view of the distal tip of the syringe of Fig. 8. Specific details for implementing the invention
[0052] In the following detailed description, reference is made to the accompanying drawings, which form part of this specification. The exemplary features illustrated and described in the detailed description, drawings, and claims are not intended to be limiting. Without departing from the scope of the subject matter presented in this specification, other features may be utilized and other modifications may be made.
[0053] Before describing in detail the various embodiments of syringe assemblies and their various features, it should be noted that the various embodiments disclosed herein are not limited in their application or use to the details of the configuration and arrangement of parts illustrated in the accompanying drawings and descriptions. Rather, the disclosed devices may be positioned or integrated into other devices, variations and modifications thereof, and may be implemented or performed in various ways. Accordingly, the embodiments of syringes and syringe features disclosed herein are by nature illustrative and are not intended to limit their scope or application. Furthermore, unless otherwise stated, the terms and expressions employed herein are chosen for the convenience of the reader to describe the various embodiments of syringes and syringe features and are not intended to limit their scope. Additionally, it should be understood that any one or more of the components of syringes and syringe features, their expressions, and / or examples thereof may be combined without limitation with any one or more of the other components, their expressions, and / or examples thereof.
[0054] Furthermore, it should be understood that in the following description, terms such as anterior, posterior, internal, external, upper, and lower are for convenience only and should not be interpreted as restrictive terms. When used herein, the term "proximal" is used to describe a portion of a syringe, generally to indicate the portion of the syringe closer to the injector, and when used to describe a portion of the syringe, the term "distal" is used to describe the portion of the syringe closer to the patient (i.e., the nozzle end of the syringe). The terms used herein are not intended to be limiting, as long as the device or a portion thereof described herein may be attached or utilized in a different orientation. Various aspects of the syringe and syringe features will be described in more detail with reference to the drawings.
[0055] The present disclosure relates to the design of a syringe for use with a powered fluid injector used in medical imaging procedures. According to various embodiments, certain medical imaging procedures may include the injection of a contrast medium or a contrast agent to highlight specific features of a medical image. This process, known as contrast-enhanced medical imaging, generally involves injecting a contrast medium along with an appropriate irradiating agent, such as saline, before or during the imaging process. A powered fluid injector is used to control the injection of fluids and is typically designed with one or more syringes to hold and dispense the contrast medium, irradiating fluid, and other medical fluids administered before or during the imaging procedure. For example, U.S. Patents No. 5,383,858; No. 6,652,489; No. 7,563,249; No. 8,945,051; No. 9,173,995; and Patent No. 10,507,319 discloses front-loading syringes and motorized injectors in examples with and without pressure jackets, the contents of which are incorporated herein by reference. Common contrast-enhanced medical imaging procedures include computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET, SPECT), and angiography (CV). Due to the need to deliver contrast volume over a short period of time through viscous and small-diameter tubing sets and / or catheters, certain injection procedures may be performed at high injection pressures, such as up to 300 psi for CT and MRI, and up to 1200 psi for CV procedures, to provide a "closed bolus." The injector may be configured to inject or dispense a fluid medium contained in a first, second, and / or additional syringe in a controlled manner, which may be used in medical procedures such as angiography, CT, PET, and NMR / MRI.
[0056] During the injection process, many potential problems that must be avoided may occur, such as, first and foremost, difficulty or slow loading of the syringe into the pressure jacket; disengagement of the syringe from the fluid injector due to deformation or failure of the syringe or high injection pressure; dripping of contrast agent or saline that may contaminate one or more surfaces on the syringe or injector components; air inhalation into the syringe and potential air injection into the patient; slow filling speeds due to bubble formation; and inability to observe the syringe contents. The syringe and features described herein mitigate or prevent one or more of these problems.
[0057] According to a first embodiment, the present disclosure provides a syringe (2) that may include a proximal end (4), a distal end (6), and a cylindrical sidewall (8) extending between the proximal end (4) and the distal end (6). The distal end (6) may include a fluid nozzle (10) at the distal end (12) of a conical distal end wall (14) as illustrated in FIGS. 1 through 3. In various embodiments of the present disclosure, the syringe (2) may include an embodiment of a tubing or spike clip (16) as described in International PCT Application PCT / US2021 / 018523, the full text of which is incorporated herein by reference. In other embodiments, the syringe may include a Luer-type connector (not shown) or other connector mechanism for connecting the syringe to a tubing set and / or spike.
[0058] According to a specific embodiment, the syringe (2) may include a cylindrical load-bearing wall (18) extending distally from a cylindrical side wall (8) through a proximal end (20) of a conical distal wall (14). The cylindrical load-bearing wall (18) may protrude along a longitudinal axis (L) and provide a distal surface (22) configured to abut against an inner proximal surface (100) of one or more retaining elements (102) at the distal end of one or more retaining arms (103) (see FIG. 7a and FIG. 7b) to retain the syringe (2) within a pressure jacket, retain the syringe (2) in a state engaged with a fluid injector, and support a load associated with pressurized fluid delivery (e.g., a load generated by the motor of the fluid injector when pressurizing fluid using an electric piston). For example, in a CT injection protocol, the cylindrical load-bearing wall (18) may be configured to support a load of at least 300 psi. According to another embodiment during a CV injection protocol, the cylindrical load-bearing wall (18) may be configured to support a load associated with the high pressure of angiographic injection. For example, in a specific angiographic injection, the fluid in the syringe (2) may be pressurized up to 1200 psi. Typically, high pressure may be required to deliver a viscous contrast agent or a less viscous saline solution through a small-diameter catheter associated with a CV injection procedure. As the cylindrical load-bearing wall (18) abuts the inner wall of the distal end of the pressure jacket, the load from the syringe (2) is transferred to one or more retaining elements (102) at the distal end of one or more retaining arms (103) and ultimately to the frame feature of the fluid injector. The cylindrical load-bearing wall (18) may be continuous or discontinuous around the circumference of the distal end (6) of the syringe (2). In a specific embodiment, the cylindrical load-bearing wall (18) is continuous around the circumference of the distal end (6) of the syringe (2).
[0059] In a specific embodiment, as illustrated in FIGS. 2 and 3, the cylindrical load-bearing wall (18) extends from the cylindrical side wall (8) toward the distal end and flares out from therefrom, so that the distal outer diameter of the load-bearing wall (18) is larger than the outer diameter of the cylindrical side wall (8). According to a specific embodiment, the cylindrical load-bearing wall (18) may flare out at an angle of 1° to 30° with respect to the longitudinal axis (L) of the syringe (2). The flared cylindrical load-bearing wall (18) allows the syringe (2) to be easily installed in the pressure jacket (104) and allows the syringe (2) and the corresponding plunger to engage with the piston of the fluid injector. For clarity, the flared surface (19) flares out from the outer surface of the cylindrical side wall (8) to the distal surface (22) of the load-bearing wall (18). For example, as illustrated in FIGS. 7a and 7b, as the syringe descends into the pressure jacket past one or more retaining elements (102), the expanding cylindrical load-bearing wall (18) can push one or more retaining elements (102) and the corresponding retaining arm (103) outward. The user may need to apply a predetermined amount of downward force to cause the one or more retaining elements (102) to move outward against the deflection restoring force (for example, the fluid injector and pressure jacket assembly may be in a vertical position with the open end of the pressure jacket facing vertically upward). When the distal end of the cylindrical load-bearing wall (18) is pushed past the inner proximal surface (100) of one or more retaining elements (102), the deflection restoring force can snap the one or more retaining elements (102) back to an initial position where the inner proximal surface (100) of one or more retaining elements (102) abuts the distal inclined surface of the cylindrical load-bearing wall (18) when the syringe (2) and the plunger are placed under load by the piston of the fluid injector.In this manner, the technician may install the syringe (2) into the injector by simply applying a downward force to the syringe until the syringe (2) snaps into the pressure jacket assembly. In certain embodiments, an audible indication, such as a click or snap-fastening sound, may be heard when one or more retaining elements snap-close to indicate that the syringe is installed correctly. The snap-fastening closure may also provide the technician with a visual indication that the syringe is installed correctly. Removal of the syringe (2) may be performed manually by the technician or by the outward movement of one or more retaining elements (102) and the corresponding retaining arm (103) by the motor of the injector. A suitable embodiment of the retaining arm mechanism is described in International PCT Application No. PCT / US2020 / 049885, the disclosure of which is incorporated herein by reference.
[0060] In various embodiments, the outer diameter of the expanding cylindrical load-bearing wall (18) may be in close contact with the side wall of the pressure jacket (104) and / or one or more retaining elements (102), and may substantially prevent any leaked medical fluid, such as contrast agent or saline, from entering between the cylindrical side wall (8) of the syringe (2) and the pressure jacket (104) (see FIG. 7a). In certain embodiments, the compliance resulting from the pressurization of the syringe (2) and the swelling of the side wall (8) and the distal end wall (14) of the syringe (2) under pressurization may further seal the cylindrical side wall (8) of the syringe (2) against the pressure jacket (104) and / or one or more retaining elements (102), thereby further increasing the sealing characteristics of the interaction. According to various embodiments, an elastomer coating or material may be placed on the inner proximal surface (100) of one or more retaining elements (102) and / or the distal surface (22) of a cylindrical load-bearing wall (18) to form a tight seal between them when a syringe comes into close contact with one or more retaining elements (102).
[0061] Referring to FIGS. 1 through 4, the distal end (6) of the syringe (2) may further include a plurality of radial ribs (24) positioned around the periphery of the conical distal end wall (14). The plurality of radial ribs (24) extend inward toward the fluid nozzle (10) from the inner edge of the cylindrical load-bearing wall (18) across at least a portion of the conical distal end wall (14). In certain embodiments, the radial ribs (24) may be provided at different lengths along the cylindrical load-bearing wall (18). In other embodiments, the plurality of radial ribs may extend only a short distance along the conical distal end wall (14), for example, less than 1.5 cm. When shorter radial ribs (24) are used, for example, when the fluid injector is in an upright vertical position and the bubbles rise toward the distal end of the conical end wall (14) due to the natural buoyancy of one or more bubbles, it may be easier for the user to identify one or more bubbles in the syringe (2) because the radial ribs (24) do not significantly obstruct the user's view of the syringe (2). According to various embodiments, a plurality of radial ribs (24) define a plurality of fluid holding channels (26) between them. Each fluid holding channel (26) may be located between each pair of adjacent radial ribs (24). The plurality of fluid holding channels (26) may be configured to hold the volume of liquid previously dropped from the fluid nozzle (10). For example, the fluid in the fluid holding channel (26) will be held in the fluid holding channel (26) when the syringe (2) is rotated from a first vertical upward facing position to a second inclined downward facing position. Capillary aggregation (also known as capillary action) and the surface tension of the fluid can cause the volume of the liquid to be maintained within a plurality of fluid-holding channels (26) against gravity. Additionally, a plurality of radial ribs (24) can be in contact with the inner wall of the cylindrical load-bearing wall (18) to further retain the fluid.For example, in a specific embodiment, the syringe (2) may be filled with a fluid, such as a contrast agent, saline, or other medical fluid, with the injector head and distal end (6) of one or more syringes (2) in an upright position to facilitate filling with fluid, for example, through a spike, and / or to control and visualize the amount of air drawn into the syringe (2) during the filling process. In a specific embodiment, during filling through a spike or fluid path, transition between the filling fluid path and the delivery fluid path, or during purging of air, for example, when the spike or fluid path is removed after filling or purging, a small amount of fluid may seep out of the fluid nozzle (10) of the syringe (2).
[0062] In many conventional fluid injection procedures, after the upright configuration filling process, the injector head may be rotated so that the distal end (6) of one or more syringes (2) slopes downward to ensure that any air that may remain in the syringe (2) due to buoyancy rises to the proximal end (4) of the syringe (2), thereby reducing the possibility of air injection and embolism. In the case of conventional syringe designs, the volume of the injected fluid may flow below the outer surface of the syringe, potentially soiling or contaminating various surfaces of the fluid injector. In certain examples, a small amount of fluid may drip from the syringe to the bottom, posing a risk to technicians and patients and / or contaminating various surfaces within the fluid injection product family. Additionally, because many contrast agents are sticky and viscous solutions, a sticky film may accumulate on the bottom and other surfaces, potentially posing a safety hazard and increasing unnecessary contact with contrast or other medical fluids, which may require additional cleaning operations.
[0063] According to various embodiments, a plurality of fluid holding channels (26) may be configured to maintain the volume of liquid dropped from the fluid nozzle (10), for example, by capillary aggregation or action between adjacent radial ribs (24). As illustrated in FIG. 4, the gap widths between adjacent radial ribs (24) may be referred to as d1, d2, and d3, and in some embodiments, the gap widths are constant such that d1=d2=d3, and in other embodiments, the gap widths are variable such that d1≠d2≠d3. With respect to the latter embodiment, d1 <d2<d3 또는 d1> d2 > d3 or an appropriate gap width may be determined in several other ways without limitation. In various embodiments, because adjacent radial ribs (24) are arranged radially, the gap width may increase with a radial distance from the center longitudinal axis (L) of the syringe (2). Alternatively, the gap width may be kept constant by increasing the width of the radial ribs (24) with a radial distance from the center axis. According to various embodiments, the distance between two adjacent radial ribs (24) defining the gap (i.e., "d") associated with the fluid-retaining channel (26) may be in the range of 0.01 inch to 0.25 inch. Further details regarding capillary action are described in International PCT Publication No. WO 2017 / 091636, the disclosure of which is incorporated herein by reference.
[0064] According to a specific embodiment, a plurality of fluid holding channels (26) can maintain a maximum total volume of fluid in the range of 0.1 mL to 0.8 mL when the syringe (2) is rotated from a first upward facing position to a second inclined downward facing position. In another embodiment, the maximum total volume of fluid can be controlled by changing the height of a plurality of radial ribs and / or changing the distance between adjacent radial ribs. In a specific embodiment, the capillary volume of fluid that can be maintained by adjacent radial ribs (24) is determined at least partially from the distance between each adjacent pair of radial ribs (24), the height of each adjacent pair of radial ribs (24), and the distance that each adjacent pair of radial ribs (24) extends distally inwardly along the conical distal end wall (14). That is, the volume of the fluid can be determined by one or more of the distance between adjacent pairs of radial ribs (24), the depth of the fluid holding channel (26) between adjacent pairs of radial ribs (24), the length of adjacent pairs of radial ribs (24), and the related length of the fluid holding channel (26).
[0065] In a specific embodiment, at least a portion of the plurality of radial ribs (24) extend from the cylindrical load-bearing wall (18) by different distances across the conical distal end wall (14). For example, in FIG. 4, the plurality of radial ribs (24) may extend from the cylindrical load-bearing wall (18) across a portion of the conical distal end wall (14) of the syringe (2). In another embodiment, as illustrated in FIG. 5, the plurality of radial ribs (24) may extend from the cylindrical load-bearing wall (18) toward the fluid nozzle (10) of the syringe (2) over the conical distal end wall (14) of the syringe (2).
[0066] As illustrated in FIG. 5, a plurality of radial ribs (24) may extend from the cylindrical load-bearing wall (18) by different distances, and some of the radial ribs (24) may have different heights compared to other of the radial ribs (24) (see FIG. 5). As can be seen in the drawings, in various embodiments, the plurality of radial ribs (24) are in contact with the cylindrical load-bearing wall (18) of the syringe (2) to help direct medical fluid into the fluid-holding channel (26) and to form a reservoir on the distal end (6) of the syringe (2) that provides additional volume for holding fluid in a reservoir having the cylindrical load-bearing wall (18) as a fluid-holding wall.
[0067] In another embodiment, as shown in FIG. 6, a plurality of ribs (24) may be circumferential and may be arranged concentrically around the conical distal end wall (14). Concentric circumferential ribs (28) may be arranged from the cylindrical load-bearing wall (18) toward the fluid nozzle (10) of the syringe (2).
[0068] In various embodiments, including the syringe (2) illustrated in FIGS. 1 to 6, a plurality of radial ribs (24) and / or a plurality of circumferential ribs (28) may increase the load strength of the conical distal end wall (14). For example, the plurality of radial ribs (24) or circumferential ribs (28) may provide increased thickness to the conical distal end wall (14) where the radial ribs (24) or circumferential ribs (28) are located, thereby reinforcing the strength of the conical distal end wall (14). In various embodiments, the increased wall strength may help withstand and limit compliance expansion of the conical distal end wall (14) during a pressurized fluid injection procedure. According to various embodiments, an increased thickness to the conical distal end wall (14) where the radial rib (24) or circumferential rib (28) is located can reduce the need for pressure jacket reinforcement of the conical distal end wall (14). For example, as illustrated in FIG. 7a, the pressure jacket (104) may be substantially cylindrical in contact with the syringe retaining element (102), and the conical distal end wall (14) of the syringe (2) can withstand high injection pressure (up to 1200 psi) without any reinforcement from the pressure jacket (104) and / or the syringe retaining element (102). This can enable easy visualization of the conical distal end wall (14) by a user, for example, to check the liquid volume filling and the presence or absence of one or more bubbles in the syringe (2).
[0069] In a specific embodiment, a plurality of radial ribs (24) can increase the load strength of the cylindrical load-bearing wall (18). For example, a plurality of radial ribs (24) are abutted and connected to the cylindrical load-bearing wall (18). This can increase the load strength of the cylindrical load-bearing wall (18), for example, by increasing the hoop strength of the wall. The connection between the plurality of radial ribs (24) and the cylindrical load-bearing wall (18) can also increase the load strength of the cylindrical load-bearing wall (18) by preventing inward or outward deformation or bending of the cylindrical load-bearing wall (18) when a pressure load is applied to the syringe (2).
[0070] As illustrated in FIGS. 3 and 8, according to one embodiment of the present disclosure, the proximal end (4) of the syringe (2) may have a wider diameter (D1) than the diameter (D2) of the rest of the cylindrical sidewall (8). In this example, the “operating zone” 7) of the syringe (2) through which the plunger (106) is pushed through the fluid passage of the cylindrical sidewall (8) may have a smaller diameter (D2) compared to the diameter (D1) of the “plunger storage zone” 5) at the proximal end (4). According to the present embodiment, the plunger storage zone (5) is the area of the syringe where the plunger is placed during manufacturing and storage, and the wider diameter (D1) prevents compression of the outer circumference of the rubber plunger cover during shipping and storage. This ensures a tight seal between the syringe sidewall (8) and the rubber cover of the plunger when the plunger is moved from the wider diameter (D1) of the storage area (5) to the narrower diameter (D2) of the working area (7) of the syringe (2). In various embodiments of the present disclosure, the fluid injector holding the syringe (2) can measure the force on the piston motor associated with pushing the plunger (106) through the fluid passage of the syringe (2), and in particular the extra force required to move the plunger (106) from the wider diameter (D1) of the storage area (5) to the narrower diameter (D2) of the working area (7) of the syringe (2). Based on the force applied to the piston by the fluid injector, the fluid injector can determine the size of the syringe (2) used in the fluid injector. For example, in a longer syringe (2) holding 200 mL of fluid, the piston can push the plunger through the proximal end (4) of the syringe (2) from the plunger holding area (5) having a diameter (D1) to the working area (7) having a diameter (D2). Since D1 is larger than D2, less force is required to push the piston through the proximal end (4) of the syringe (2) than to pass through the working area (7) of the syringe (2).Accordingly, the fluid injector can correct the piston position in the case where the plunger (106) is pushed into the operating zone (7) of the syringe (2) based on the change in force applied to the piston when moving from the storage zone (5) at the proximal end (4) having a diameter (D1) to the operating zone (7) having a diameter (D2). In the case of a longer and larger volume syringe having a larger operating area (7), the change in force applied to the piston occurs at a predetermined piston position corresponding to the proximity of the proximal end (4) of the syringe (2) to the injector head, whereas in the case of a shorter and smaller volume syringe having a smaller operating area (7) (e.g., 100 mL or 50 mL) positioned more distally from the pressure jacket (i.e., when the distal end (6) of the syringe (2) comes into contact with the syringe holding element (102), the change in force applied to the piston will occur at a predetermined piston position where the piston extends further along the piston path in correspondence with the fact that the proximal end (4) of the syringe (2) and the plunger are further away from the injector head from the initial position.
[0071] The position where the fluid injector registers the change in force applied to the piston due to moving the plunger from the storage area (5) to the operating area (7) allows the injector to determine the length and, therefore the volume, of the syringe loaded in the pressure jacket and, based on this information, make various adjustments to suit any programmed injection procedure. Additionally, if the fluid injector notes that no change in piston force has occurred, or otherwise notes a deviation from the expected position of the force change, the fluid injector may stop the fluid injection procedure and notify the technician that an error has occurred. For example, if the syringe is accidentally reused, the plunger is likely not in the initial storage area (5) and the position of the force change is not in the expected position, so the fluid injector may notify the technician to prevent the unintended reuse of the syringe. Likewise, if the plunger is accidentally moved to the operating area (7), for example, during shipping, the fluid injector will note that the force change has been missed and prevent the use of a potentially damaged syringe (e.g., the fluid seal between the plunger and the syringe sidewall may be damaged).
[0072] In another embodiment, as illustrated in FIG. 7a, the cylindrical load-bearing wall (18) may have a distal surface (22) configured to interface and abut the proximal surface (100) of the syringe holding element (102) of the syringe holding arm (103) of the fluid injector. According to a specific embodiment, the distal surface (22) of the cylindrical load-bearing wall (18) may be radially angled such that the inner circumferential edge of the distal surface (22) is proximal along the longitudinal axis to the outer circumferential edge of the distal surface (22). According to this embodiment, the corresponding proximal surface (100) of the syringe holding element (102) is radially angled in a similar direction that is complementary to the radial angle of the distal surface (22) of the cylindrical load-bearing wall (18). According to various embodiments, the angle of the distal surface (22) may be in the range of 1° to 89°, and in certain embodiments, 1° to 30°, and the angle of the corresponding proximal surface (100) is complementary. Thus, when the syringe (2) is under load during the transfer process, the radially inclined distal surface (22) of the cylindrical load-bearing wall (18) interfaces with the corresponding radially inclined proximal surface (100) of the syringe holding element (102), the two surfaces (22 and 100) interact as the pressurized syringe (2) is compressed distally along the longitudinal axis (L), and accordingly, a holding force is established on the holding arm (103) to maintain a closed configuration by compressing the holding arm (103) radially inward. In this way, the force holding the syringe (2) within the pressure jacket (104) and the holding mechanism of the fluid injector are increased during the pressurized delivery of the fluid during the contrast injection procedure. In one non-limiting example, when the syringe (2) is inserted into the fluid injector, the cylindrical load-bearing wall (18) may be configured to move the holding arm (103) outward to open the holding arm (103), thereby allowing the syringe (2) to move into the fluid injector.After the syringe (2) moves past the syringe holding element (102), the holding arm (103) can be configured to move inward so as to be close to each other to hold the syringe (2) in the fluid injector.
[0073] As described in U.S. Patent No. 10,420,902 (the disclosure thereof incorporated herein by reference) and illustrated in FIGS. 8 and 9, the presence of a small amount of air (up to 5% of the total volume of the syringe) within the syringe (2) may be visualized by the presence or absence of an illuminated halo (40a) at the conical distal end (6) of the syringe (2). For example, electromagnetic radiation may be reflected and refracted from a colored surface or may appear through a translucent or transparent plunger cap (from a light source in the piston head). When the syringe (2) is fully filled with liquid fluid, the electromagnetic radiation will be refracted / reflected against the syringe sidewall (8) and the conical distal end wall (14) to produce a refracted halo effect in the form of an illuminated halo (40a) around the circumference of the distal portion of the conical distal end (6) of the syringe (2). If a small amount of air (e.g., more than 5 mL) is present, an illuminated halo (40a) is not observed. This provides a method for a technician to visually determine whether there is air in the syringe (2), perform a purge / priming operation to remove the air, and prevent air from being injected into the patient. In certain embodiments, the visualization process may also be performed by an injector if a suitable camera and associated software are installed. According to various embodiments of the present disclosure, at least one of the cylindrical load-bearing wall (18) and a plurality of radial ribs (24) can enhance the amount of electromagnetic radiation refracted at the distal end (6) of the syringe (2) when the syringe (2) is filled with liquid. For example, the plurality of radial ribs (24) can act similarly to Fresnel lenses and increase the reflection / refraction of electromagnetic radiation to create a brighter illuminated halo around the circumference of the distal part of the conical distal end (6) of the syringe (2). In another embodiment, electromagnetic radiation may also be reflected back from the distal end of the cone to illuminate a halo (40b) around at least part of the circumference of the cylindrical load-bearing wall (18), for example, around a plurality of radial ribs (24).In a specific embodiment, electromagnetic radiation may be emitted from at least one electromagnetic radiation source located in the piston head of the fluid injector. In another embodiment, electromagnetic radiation may be reflected from at least a portion of the surface of the plunger (106) of the syringe (2).
[0074] In certain embodiments, the syringe (2) of the present disclosure may include one or more features that improve fluid flow into and out of the syringe (2) during the fluid filling and fluid delivery process. According to various embodiments, the syringe (2) may include a neck portion associated with the fluid nozzle (10) at the distal end (6) of the syringe (2). The neck portion may include a larger diameter than that of a conventional syringe to accommodate a connector element, for example, as described in International PCT Application No. PCT / US2021 / 018523. The neck portion of the syringe (2) may include a fluid passage having a plurality of fluid diversion ribs (30) extending at least partially radially inward from the inner surface of the neck portion into the fluid passage, as illustrated in FIGS. 3 and 4.
[0075] According to various embodiments, a plurality of fluid diversion ribs (30) may divert fluid flowing through the fluid nozzle (10) during the filling procedure to the syringe (2) so that the fluid flows along the inner surface of the conical distal end wall (14) and the cylindrical side wall (8) of the syringe (2). In certain embodiments, the plurality of fluid diversion ribs (30) may include ribs extending radially inward for different distances (compare ribs (30 and 31) in FIG. 4) and / or may extend for different lengths along the longitudinal axis (L) of the fluid nozzle (10). Although no intention is to limit the interpretation, the diversion of fluid flow through the syringe fluid nozzle (10) is believed to be a result of the Coanda effect, wherein the fluid diversion ribs (30) result in the fluid adhering to the inner side wall of the conical distal end wall (14) and the cylindrical side wall (8) of the syringe (2). For example, capillary aggregation of the fluid against the wall of the fluid diversion rib (30) can cause surface tension to hold the fluid against the inner sidewall of the neck and continue to the inner sidewall of the conical distal end wall (14) and the cylindrical sidewall (8). Instead of allowing the fluid to flow into the syringe without contacting the inner sidewall, allowing the fluid to flow under the inner sidewall of the syringe results in fewer bubbles in the fluid during the filling procedure. In contrast, in the case of a conventional syringe without the fluid diversion rib (30), the fluid may flow / drop down the middle of the syringe fluid nozzle (10) and drop into the plunger (106), forming bubbles in the fluid. These bubbles can adhere to the plunger (106) and the sidewall surface and are typically difficult to remove during the priming sequence. The resulting bubbles can increase the risk of air embolism by introducing small amounts of air, particularly in angiography procedures. As mentioned, especially in the case of high-pressure CV imaging procedures, any air bubbles must be avoided in the syringe and / or fluid pathway to prevent air embolism.According to these embodiments, the fluid diversion rib (30) minimizes the amount of bubbles in the fluid within the syringe (2). Previous research has shown that a fluid diverter located in the middle of the flow path passing through the nozzle reduces bubble formation during filling (e.g., see International PCT Publication No. WO 2017 / 091643, the disclosure incorporated herein by reference). The described fluid diversion rib (30) provides a similar effect without requiring a fluid diverter feature in the flow path, thereby simplifying the manufacture and injection molding of the syringe (2). The amount of bubbles in the fluid within the filled syringe (2) can be minimized by the fluid flowing along the inner surface of the distal end wall (14) and the cylindrical side wall (8) of the syringe (2), rather than flowing directly from the syringe fluid nozzle (10) to the plunger surface. In one embodiment of the present disclosure, the fluid diversion rib (30) may also increase the illuminated circumferential halo effect described herein to identify whether bubbles are present in the syringe (2). As observed in the plurality of radial ribs (24), the fluid diversion rib (30) may amplify and further reflect / refract incident electromagnetic radiation, thereby increasing the brightness of the illuminated halo observed around the circumference of the distal portion of the conical distal end (6) of the syringe (2). In a specific embodiment, at least some of the plurality of fluid diversion ribs (30) may have different cross-sectional profiles. In another embodiment, at least some of the plurality of fluid diversion ribs (30) may extend from the inner surface of the fluid nozzle (10) for different distances to the distal portion of the conical distal end (6) of the syringe (2).
[0076] According to various embodiments, a plurality of fluid switching ribs (30) may also allow for a potentially increased filling speed due to more laminar flow of fluid into the syringe (2) as the fluid passes through the fluid switching ribs (30), for example. Thus, the time between procedures may be significantly reduced because the syringe can be filled faster than a conventional syringe. Additionally, the filling speed may be increased because bubble formation during filling is reduced, resulting in a smaller prime volume and a lower generation of waste fluid associated with a larger prime volume.
[0077] According to various embodiments, the features described herein can increase the ease of injection molding of the syringe (2). For example, the syringe (2) may be formed from medical-grade plastics such as PET, polycarbonate, polyethylene, and mixtures thereof, and may be formed into a syringe shape by an injection molding process. During injection molding, features may cause problems while removing the article from the mold, such as having undercuts due to the features. Additionally, certain features may require specific and expensive mold configurations that can still result in a high rejection rate. According to various embodiments of the syringe (2) and the features described therein, the configuration of a plurality of radial ribs (24), fluid diversion ribs (30), and cylindrical load-bearing walls (18) can eliminate undercuts from the injection mold for injection molding the syringe (2).
[0078] A number of beneficial features for the syringe (2) are described in this disclosure. It should be noted that various combinations of the described features may be incorporated into the syringe as required by the intended use of the syringe and the features of the fluid injector. For example, the syringe may include at least one of the features and, as needed, various other described features. For example, according to an embodiment, the syringe may include a plurality of radial ribs (24) and a cylindrical load-bearing wall (22) around the periphery of the conical distal end wall (14) as described herein, but may not include a plurality of fluid diversion ribs (30). According to another embodiment, the syringe may include a plurality of radial ribs (24), a cylindrical load-bearing wall (22), and a plurality of fluid diversion ribs (30) around the periphery of the conical distal end wall (14) as described herein. According to another embodiment, the syringe may include a cylindrical load-bearing wall (22) and a plurality of fluid-transferring ribs (30), but may not include a plurality of radial ribs (24) as described herein. Accordingly, the various embodiments described in detail herein and illustrated in the accompanying drawings are merely illustrative and do not in any way limit the features incorporated into the syringe.
[0079] Although various embodiments and features of syringe assemblies have been described in relation to syringes for powered medical injectors, the syringe assemblies and features described herein may also be incorporated into handheld syringes to deliver fluid at low injection pressures. For example, in many medical settings where fluid must be injected by a handheld syringe, a physician may draw fluid from a corresponding fluid container, such as a vial, into the syringe, and then prime or purge any air from the syringe by holding the syringe in a vertical position and pressurizing the plunger assembly to deliver a small amount of fluid along with any air contained within the syringe. The released fluid may drip down the side of the needle and the bottom of the syringe body, potentially exposing the physician to contact with the medical fluid. The syringe assemblies and features described herein may be utilized in handheld syringes to prevent fluid dripping released during the priming process or fluid dripping during the injection process from coming into contact with the physician or falling onto surfaces. Handheld syringes comprising various embodiments and features of syringe assemblies are within the scope of this disclosure.
[0080] Another aspect of the present disclosure relates to other medical devices comprising the syringe assembly and various features described herein. For example, any medical device delivering fluid, which may include leaking or dripping a small amount of fluid from a fluid opening to its surface, may benefit from the fluid wicking flange of the present disclosure. Examples of such medical devices include, but are not limited to, catheters (e.g., a distal end or a portion positioned immediately outside the patient's body), tubing sets, IV lines, tubing connectors and clips, shunts, fluid manifolds, valves, suction tubing, surgical instruments, pump fluid outputs, etc., and all of these may be modified to include the various features described herein.
[0081] It is worth noting that any reference to "one embodiment" or "one embodiment" implies that a specific feature, structure, or characteristic described in relation to the embodiment is included in at least one embodiment. Therefore, the appearance of the phrases "in one embodiment" or "in one embodiment" at various locations throughout the specification does not necessarily refer to the same embodiment. Furthermore, a specific feature, structure, or characteristic may be combined in any appropriate manner in one or more embodiments.
[0082] Those skilled in the art will recognize that the components (e.g., operations), devices, objects, and accompanying descriptions described herein are used as examples for conceptual clarity and that various configuration modifications are considered. Consequently, when used herein, the specific examples and accompanying descriptions are intended to represent a more general class. In general, the use of any specific example is intended to represent that class and should not be taken as a limitation the non-inclusion of specific components (e.g., operations), devices, and objects.
[0083] With respect to the use of any plural and / or singular terms in this specification, those skilled in the art may translate from plural to singular and / or singular to plural as appropriate to the context and / or application. Various singular / plural permutations are not explicitly stated in this specification for the sake of clarity.
[0084] The subject matter described herein sometimes exemplifies different components that are included within or connected to other different components. It should be understood that the architectures illustrated are merely illustrative and that many other architectures may be implemented to achieve the same function. Conceptually, any arrangement of components to achieve the same function is effectively "related" so that the desired function is achieved. Accordingly, any two components combined in this specification to achieve a specific function may be considered "related" to each other so that the desired function is achieved, regardless of the architecture or intermediate components. Likewise, any two components thus related may be considered "operably connected" or "operably coupled" to each other to achieve the desired function, and any two components that may be so related may also be considered "operably coupled" to each other to achieve the desired function. Specific examples of operable coupling include, but are not limited to, physically matable and / or physically interacting components, and / or wirelessly interacting and / or wirelessly interacting components, and / or logically interacting and / or logically interacting components.
[0085] Some modalities may be described using the expressions "combined" and "connected" in conjunction with derivatives. It should be understood that these terms are not intended to be synonyms for one another. For example, some modalities may be described using the term "connected" to indicate that two or more elements are in a state of direct physical or electrical contact with each other. In other examples, some modalities may be described using the term "combined" to indicate that two or more elements are in a state of direct physical or electrical contact with each other. However, the term "combined" may also mean that two or more elements are not in direct contact with each other but still cooperate or interact with each other.
[0086] In some examples, one or more components may be referred to herein as “configured to,” “operating,” “adapted,” etc. Those skilled in the art will recognize that, unless otherwise required by the context, “configured to” may generally include active components and / or inactive components and / or standby components.
[0087] Although specific aspects of the subject matter described herein have been illustrated and described, it will be apparent to those skilled in the art that, based on the teachings of this specification, changes and modifications may be made without departing from the subject matter described herein and its broader aspects, and thus the appended claims must include within the scope of all such changes and modifications that fall within the scope of the subject matter described herein. Generally, those skilled in the art will understand that the terms used in this specification, particularly in the appended claims (e.g., the body of the appended claims), are generally intended to be "open" terms (e.g., the term "comprising" should be interpreted as "comprising but not limited thereto," the term "having" as "at least having," the term "comprising" as "comprising but not limited thereto," etc.). Where a specific number of introduced claim references are intended, such intention will be explicitly cited in the claims, and it will be further understood by those skilled in the art that where such references are absent, such intention does not exist. For example, for the sake of understanding, the following appended claims may include the use of introductory phrases such as “at least one” and “one or more” to introduce claim citations. However, the use of such phrases, even if the same claim includes the introductory phrases “one or more” or “at least one” and an indefinite article such as “a” or “an” (e.g., “a” and / or “an” should be interpreted as meaning “at least one” or “one or more”), the introduction of a claim citation by the indefinite article “a” or “an” must not be interpreted to mean that any particular claim containing such introduced claim citation is limited to a single claim containing such citation; the same applies to the use of the definite article used to introduce claim citations.
[0088] Furthermore, even if a specific number of introduced claim citations is explicitly cited, a person skilled in the art will recognize that such citations should be interpreted to mean at least the number cited (e.g., a bare recitation of “two citations” without other modifiers typically means at least two citations or two or more citations). Moreover, in such cases where conventions similar to “at least one of A, B, and C, etc.” are used, such constructions are generally intended to be understood by a person skilled in the art in the sense that they understand such convention (e.g., “a system having at least one of A, B, and C” includes, but is not limited to, systems having only A, only B, only C, A and B together, A and C together, B and C together, and / or A, B, and C together, etc.). In such cases where conventions similar to “at least one of A, B, or C, etc.” are used, such structure is generally intended to be understood by a person skilled in the art as such convention (e.g., “a system having at least one of A, B, or C” includes, but is not limited to, systems having only A, only B, only C, A and B together, A and C together, B and C together, and / or A, B, and C together, etc.). Furthermore, it will be understood by a person skilled in the art that any typically disjunctional words and / or phrases providing two or more alternative terms, whether in the detailed description, claims, or drawings, should be understood to include the possibility of one of the terms, either of the terms, or both, unless the context otherwise indicates. For example, the phrase “A or B” will be understood to include the possibility of “A” or “B” or “A and B”.
[0089] In summary, numerous advantages resulting from adopting the concepts described herein have been explained. The foregoing disclosures are provided for illustrative and illustrative purposes only. They are not intended to obscure or limit the exact form disclosed. Modifications or variations are possible in light of the teachings above. The claims set forth herein are intended to limit the full scope of the disclosures.
Claims
Claim 1 A syringe comprising a proximal end, a distal end, and a cylindrical sidewall extending between the proximal end and the distal end—the distal end comprises a conical distal end wall, a neck containing a fluid passage, and a fluid nozzle at the distal end of the conical distal end wall—; a plurality of longitudinal fluid diversion ribs extending at least partially radially inward from the inner surface of the neck into the fluid passage; and a plurality of radial ribs positioned around the periphery of the conical distal end wall, wherein the longitudinal axis of the plurality of radial ribs extends radially inward from the cylindrical load-bearing wall toward the fluid nozzle across at least a portion of the conical distal end wall. Claim 2 A syringe according to claim 1, further comprising a cylindrical load-bearing wall extending axially from a cylindrical side wall through the proximal end of a conical distal end wall. Claim 3 A syringe according to claim 1, wherein a plurality of radial ribs define a plurality of fluid-retaining channels between adjacent radial ribs of each pair, and the plurality of fluid-retaining channels are configured to maintain the volume of liquid by capillary aggregation when the syringe is rotated from a first upward facing position to a second downward facing position. Claim 4 A syringe according to paragraph 3, wherein a plurality of fluid holding channels are configured to maintain a volume of liquid in the range of 0.1 to 0.8 milliliters. Claim 5 A syringe according to paragraph 3, wherein the volume of liquid maintained by a plurality of fluid-holding channels is determined at least partially from the distance between each adjacent pair of a plurality of radial ribs, the height of each adjacent pair of a plurality of radial ribs, and the distance at which each pair of radial ribs extends distally inwardly inward from the conical distal end wall. Claim 6 A syringe according to claim 1, wherein a plurality of radial ribs increase the load strength of the conical distal end wall. Claim 7 In paragraph 2, a plurality of radial ribs increase the load strength of a cylindrical load-bearing wall, a syringe. Claim 8 A syringe according to claim 1, wherein a plurality of longitudinal fluid diversion ribs are configured to divert fluid flowing through the neck to the syringe so that the fluid flows along the inner surface of the conical distal end wall and the inner surface of the cylindrical side wall. Claim 9 A syringe according to claim 8, wherein a plurality of longitudinal fluid switching ribs are configured to minimize the amount of air bubbles in the fluid within the syringe. Claim 10 In paragraph 9, a syringe in which the amount of fluid bubbles within the syringe is minimized by the fluid flowing along the inner surface of the distal end wall and the inner surface of the cylindrical side wall. Claim 11 A syringe according to claim 1, wherein at least some of the plurality of longitudinal fluid switching ribs have different profiles. Claim 12 A syringe according to claim 1, wherein at least some of the plurality of longitudinal fluid switching ribs extend from an inner surface into a fluid passage at different distances. Claim 13 In paragraph 2, the syringe, wherein the cylindrical load-bearing wall is configured to abut the retaining surface of the retaining arm of the fluid injector to retain the syringe within the pressure jacket during a pressurized injection procedure. Claim 14 A syringe according to paragraph 2, wherein the distal surface of the cylindrical load-bearing wall is radially angled from a more proximal inner part to a more distal outer part with respect to the longitudinal axis of the syringe. Claim 15 A syringe according to claim 14, wherein the angle of the distal surface of the cylindrical load-bearing wall is configured to prevent fluid from entering between the cylindrical side wall of the syringe and the pressure jacket on which the syringe is placed. Claim 16 A syringe according to claim 14, wherein the angle of the distal surface of the cylindrical load-bearing wall is configured to increase the radial inward force on the retaining arm of the fluid injector. Claim 17 A syringe according to claim 1, wherein at least one of a plurality of longitudinal fluid switching ribs and a plurality of radial ribs is configured to enhance a refractive halo effect in the distal portion of the conical distal end wall of electromagnetic radiation emitted from at least one electromagnetic radiation source in the piston or plunger head of the fluid injector. Claim 18 A syringe comprising a proximal end, a distal end, and a cylindrical sidewall extending between the proximal end and the distal end—the distal end comprises a conical distal end wall, a neck including a fluid passage, and a fluid nozzle at the distal end of the conical distal end wall—; a cylindrical load-bearing wall extending axially from the cylindrical sidewall through the proximal end of the conical distal end wall—the cylindrical load-bearing wall extends axially from the cylindrical sidewall of the syringe—; and a plurality of fluid diversion ribs extending inwardly from the inner surface of the fluid nozzle, wherein the plurality of fluid diversion ribs enhance the refractive light effect of electromagnetic radiation emitted from at least one electromagnetic radiation source in the piston or plunger head of the fluid injector at the distal portion of the conical distal end wall, and the cylindrical load-bearing wall extending radially outwardly from the cylindrical sidewall of the syringe at an angle of 1 to 30 degrees with respect to the longitudinal axis of the syringe. Claim 19 A syringe according to claim 18, further comprising a plurality of radial ribs positioned around the periphery of a conical distal end wall, wherein the longitudinal axis of the plurality of radial ribs extends radially inward toward a fluid nozzle from a cylindrical load-bearing wall across at least a portion of the conical distal end wall.
Citation Information
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