Features of angiography syringes
The syringe design addresses the challenges of complex loading, visualization, and fluid leakage in medical imaging procedures by incorporating a cylindrical load support wall and radial ribs, enhancing engagement, visualization, and reducing fluid loss, thereby improving operational efficiency and safety.
Patent Information
- Application Number
- JP2023509801
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2020-09-02
- Filing Date
- 2021-08-10
- Publication Date
- 2025-03-18
- Estimated Expiration
- 2041-08-10
AI Technical Summary
Existing syringes used in medical imaging procedures face challenges such as complex loading into pressure jackets, difficulty in visualizing the syringe filling state, and issues with fluid leakage and adhesion of contrast agents, leading to contamination and operational inefficiencies.
The syringe design incorporates a cylindrical load support wall and radial ribs along the cone distal end wall, which enhance the syringe's engagement with the fluid injector, improve visualization, and reduce fluid leakage by utilizing fluid retention grooves and fluid-turning ribs to minimize air bubbles and fluid loss.
This design facilitates easier loading and engagement with the fluid injector, enhances the visualization of the syringe filling state, and significantly reduces fluid leakage and contamination, thereby improving the operational efficiency and safety of medical imaging procedures.
Smart Images

Figure 0007648739000001 
Figure 0007648739000002 
Figure 0007648739000003
Abstract
Description
[Technical field]
[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Patent Application No. 62 / 706,340, filed August 11, 2020, and U.S. Provisional Patent Application No. 63 / 073,519, filed September 2, 2020, the disclosures of which are incorporated by reference in their entireties.
[0002] The present disclosure relates generally to features associated with angiographic syringes. The features described provide strength to the distal tip, help prevent fluid leakage from the tip, improve maneuverability, and improve the visualization process. [Background technology]
[0003] Syringe injection systems are one of the medical devices that have been used in medical imaging procedures for many years. Many such syringes are operatively connected to an inner plunger and are manually operated by advancing a plunger extension to pressurize the fluid in the syringe. However, many medical injection procedures may involve precise control and / or high pressures that cannot be achieved by manual syringe operation. Therefore, several syringes and powered injectors have been developed for use in medical procedures such as angiography (CV), computed tomography (CT) and nuclear magnetic resonance imaging (NMR) / magnetic resonance imaging (MRI). For example, U.S. Pat. No. 5,383,858 discloses front-loading syringes and powered injectors in both pressure-jacketed and non-pressure-jacketed configurations, the disclosure of which is incorporated herein by reference. [Prior art documents] [Patent documents]
[0004] [Patent Document 1] U.S. Pat. No. 5,383,858 [Patent Document 2] U.S. Patent No. 6,652,489 [Patent Document 3] U.S. Patent No. 7,563,249 [Patent Document 4] U.S. Pat. No. 8,945,051 [Patent Document 5] U.S. Patent No. 9,173,995 [Patent Document 6] U.S. Pat. No. 10,507,319 [Patent Document 7] International Application No. PCT / US2021 / 018523 [Patent Document 8] International Application No. PCT / US2020 / 049885 [Patent Document 9] International Publication No. 2017 / 091636 [Patent Document 10] U.S. Patent No. 10,420,902 [Patent Document 11] International Publication No. 2017 / 0914643 Summary of the Invention [Problem to be solved by the invention]
[0005] For certain fluid injectors, such as high pressure fluid injectors that include a pressure jacket surrounding the body of the syringe to prevent syringe expansion and / or damage under high injection pressures, loading the syringe into the fluid injector can include multiple steps to properly engage the syringe with the fluid injector and pressure jacket. For example, some pressure jackets cover a large portion of the distal end of the syringe to prevent damage to the distal end under high injection pressures. 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 distal end of the syringe can make it difficult to visualize the syringe and contents to, for example, ensure that the syringe is filled with fluid and that there are no air bubbles in the fluid.
[0006] Once the syringe is engaged with the fluid injector, to fill the syringe with contrast fluid or saline, the user typically connects a fill tube or spike to the forward nozzle or outlet of the syringe while fluidly connecting the other end of the tube / spike to a bottle or bag of contrast, saline, or other fluid. The plunger of the syringe is retracted (usually by the injector piston) to aspirate the fluid into the syringe until the syringe is filled with the desired amount. After the syringe is filled, the fill tube is removed from the syringe tip. Often, small amounts of contrast or other fluids such as saline contained in the fill tube can drip therefrom onto the floor or into the injector. Fluid dripping can also occur in a multi-patient situation, where a first portion of the syringe and tubing can be used over multiple injection procedures, while a second portion can be discarded after a single use and replaced with a new single-use portion before a subsequent injection procedure. Such droplets should be minimized and avoided as they can contaminate and foul various injector components, drip onto the floor and pose a hazard to laboratory assistants and patients, and / or contaminate various surfaces within the fluid injection chamber.
[0007] After the syringe is filled with fluid, a connector or priming tube is connected to the syringe outlet, the syringe and connector tube are primed (usually by advancing the plunger within the syringe) and the air is removed from the syringe and connector tube (i.e., to prevent air from being injected into the patient). While such techniques may be effective for removing air from the tube connected to the syringe, they are not desirable for expelling fluid from the end of the tube. Often, fluid expelled from the end of the tube will contaminate the exterior surfaces of the tube, syringe, and / or injector, drip, or leak from various connections and fall onto the floor. This is particularly undesirable when working with contrast media, which is extremely viscous and therefore tends to migrate to any surfaces the operator touches after the air is expelled from the tube.
[0008] Also, in some applications, a vent spike is placed directly on top of the syringe and is used to puncture a bottle of contrast fluid or saline to be delivered to a patient. In such applications, when the bottle and spike are removed from the syringe, any fluid remaining on the spike may leak out and drip into the tip of the syringe.
[0009] There is a need for a syringe for use in imaging procedures using contrast media that is easily engaged with an injector, allows easy visualization and characterization of syringe fill status, and improves functionality by reducing the effects of contrast agent buildup and fluid dripping. [Means for solving the problem]
[0010] The present disclosure provides syringes suitable for use in powered fluid injection in imaging procedures using contrast agents, such as computed tomography (CT), angiography (CV), and magnetic resonance imaging (MRI), that include features that reduce the effects of fluid drip as described herein, and further include other features that improve syringe function.
[0011] According to one exemplary and non-limiting embodiment, a syringe may include a proximal end, a distal end, and a cylindrical sidewall extending between the proximal and distal ends, the distal end including a conical distal end wall and a fluid nozzle at a distal end of the conical distal end wall; a cylindrical load bearing wall extending axially from the cylindrical sidewall beyond the proximal end of the conical distal end wall; and a plurality of radial ribs disposed along a periphery of the conical distal end wall, the longitudinal axes of the plurality of radial ribs extending radially inward from the cylindrical load bearing wall toward the fluid nozzle across at least a portion of the conical distal end wall.
[0012] According to one exemplary and non-limiting embodiment, the plurality of radial ribs may define a plurality of fluid retaining grooves between each pair of adjacent radial ribs, the plurality of fluid retaining grooves configured to retain a volume of fluid by capillary adhesion when the syringe rotates from a first upward position to a second downward position. The plurality of fluid retaining grooves may be configured to retain a volume of fluid in a range of 0.1 to 0.8 milliliters. The volume of fluid retained by the plurality of fluid retaining grooves may be determined at least in part from the distance between each adjacent pair of the plurality of radial ribs, the height of each adjacent pair of the plurality of radial ribs, and the distance each pair of radial ribs extends radially inwardly distally 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 to the conical distal end wall a different radial distance than the remaining radial ribs of the plurality of radial ribs. The cylindrical load support wall may be configured to retain the syringe within the pressure jacket during a pressure injection procedure by abutting against a retention surface of the retention arm of the fluid injector. The cylindrical load support wall may extend axially from the cylindrical side wall of the syringe at an angle between 1 degree and 30 degrees relative to the longitudinal axis of the syringe. The distal surface of the cylindrical load support wall may be radially inclined from a more proximal inner portion to a more distal outer portion relative to the longitudinal axis of the syringe. The angle of the distal surface of the cylindrical load support wall may be configured to prevent fluid from flowing between the cylindrical side wall of the syringe and the pressure jacket in which the syringe is disposed. The angle of the distal surface of the cylindrical load support wall may be configured to increase a radially inward force on the retention arm of the fluid injector. At least one of the cylindrical load support wall and the plurality of radial ribs may increase a refractive halo effect at a distal portion of the conical distal end wall due to electromagnetic radiation emitted from at least one electromagnetic radiation source within the piston head or plunger head of the fluid injector.A neck may be connected to a fluid nozzle at a distal end of the syringe, the neck including a fluid passageway having a plurality of fluid diverting ribs extending at least partially radially inwardly from an inner surface of the neck into the fluid passageway. The plurality of fluid diverting ribs may be configured to divert fluid flowing through the neck into the syringe such that the fluid flows along an inner surface of the conical distal end wall and the cylindrical side wall of the syringe. The plurality of fluid diverting ribs may be configured to minimize an amount of air bubbles in the fluid in the syringe. The amount of air bubbles in the fluid in the syringe may be minimized by the fluid flowing along an inner surface of the distal end wall and the cylindrical side wall of the syringe. At least some of the plurality of fluid diverting ribs may have different shapes. At least some of the plurality of flow diverting ribs may extend different distances from the inner surface into the fluid passageway. The plurality of radial ribs may extend along the conical distal end wall at an angle relative to a longitudinal axis of the syringe such that the distance between each adjacent pair of the plurality of radial ribs gradually decreases from the cylindrical load-bearing wall to the fluid nozzle.
[0013] According to one exemplary and non-limiting embodiment, a syringe may include a proximal end, a distal end, and a cylindrical sidewall extending between the proximal and distal ends, the distal end including a conical distal end wall and a fluid nozzle at a distal end of the conical distal end wall; a plurality of fluid redirecting ribs extending inwardly from an inner surface of the fluid nozzle; and a plurality of radial ribs disposed along a periphery of the conical distal end wall, the longitudinal axes of the plurality of radial ribs extending radially inwardly from the cylindrical load bearing wall toward the fluid nozzle across at least a portion of the conical distal end wall.
[0014] According to one exemplary and non-limiting embodiment, the cylindrical load bearing wall may extend axially from the cylindrical sidewall beyond the proximal end of the conical distal end wall. The plurality of radial ribs may define a plurality of fluid retaining grooves between each pair of adjacent radial ribs, the plurality of fluid retaining grooves configured to retain a volume of fluid by capillary adhesion when the syringe rotates from a first upward position to a second downward position. The plurality of fluid retaining grooves may be configured to retain a volume of fluid in a range of 0.1 to 0.8 milliliters. The volume of fluid retained by the plurality of fluid retaining grooves may be determined at least in part from the distance between each adjacent pair of the plurality of radial ribs, the height of each adjacent pair of the plurality of radial ribs, and the distance each pair of radial ribs extends radially inwardly distally from the conical distal end wall.
[0015] According to one exemplary and non-limiting embodiment, a syringe may include a proximal end, a distal end, and a cylindrical sidewall extending between the proximal and distal ends, the distal end including a conical distal end wall and a fluid nozzle at a distal end of the conical distal end wall, and a plurality of fluid diverting ribs extending inwardly from an inner surface of the fluid nozzle, the plurality of fluid diverting ribs enhancing a refractive halo effect at a distal portion of the conical distal end wall due to electromagnetic radiation emitted from at least one electromagnetic radiation source in a piston head or plunger head of the fluid injector.
[0016] According to one exemplary and non-limiting embodiment, the cylindrical load bearing wall may extend axially from the cylindrical side wall beyond the proximal end of the conical distal end wall. A plurality of radial ribs may be disposed along a periphery of the conical distal end wall, the longitudinal axes of the plurality of radial ribs extending radially inward from the cylindrical load bearing wall toward the fluid nozzle across at least a portion of the conical distal end wall. The plurality of radial ribs may define a plurality of fluid retaining grooves between each pair of adjacent radial ribs, the plurality of fluid retaining grooves configured to retain a volume of fluid by capillary adhesion when the syringe is rotated from a first upward position to a second downward position. The plurality of fluid retaining grooves may be configured to retain a volume of fluid in a range of 0.1 to 0.8 milliliters. The volume of fluid held by the plurality of fluid retaining grooves may be determined at least in part from the distance between each adjacent pair of the plurality of radial ribs, the height of each adjacent pair of the plurality of radial ribs, and the distance each pair of radial ribs extends distally radially inward from the conical distal end wall.
[0017] In one aspect, a syringe having improved characteristics is provided in accordance with the following provisions.
[0018] Clause 1: A syringe comprising: a proximal end, a distal end, and a cylindrical side wall extending between the proximal and distal ends, the distal end including a conical distal end wall, and a fluid nozzle at a distal end of the conical distal end wall; a cylindrical load bearing wall extending axially from the cylindrical side wall beyond the proximal end of the conical distal end wall; and a plurality of radial ribs disposed along a periphery of the conical distal end wall, wherein longitudinal axes of the plurality of radial ribs extend radially inward from the cylindrical load bearing wall toward the fluid nozzle across at least a portion of the conical distal end wall.
[0019] Clause 2: A syringe as described in clause 1, wherein the plurality of radial ribs define a plurality of fluid retaining grooves between each pair of adjacent radial ribs, the plurality of fluid retaining grooves being configured to retain a volume of fluid by capillary adhesion when the syringe is rotated from a first upward position to a second downward position.
[0020] Clause 3: A syringe as described in clause 2, wherein the plurality of fluid retaining grooves are configured to hold a volume of fluid in the range of 0.1 to 0.8 milliliters.
[0021] Clause 4: A syringe as described in clause 2, wherein the volume of fluid held by the plurality of fluid retaining grooves is determined at least in part from the distance between each adjacent pair of the plurality of radial ribs, the height of each adjacent pair of the plurality of radial ribs, and the distance each pair of radial ribs extends radially inwardly distally from the conical distal end wall.
[0022] Clause 5: A syringe described in any one of clauses 1 to 4, wherein a plurality of radial ribs increase the load strength of the conical distal end wall.
[0023] Clause 6: A syringe described in any one of clauses 1 to 5, wherein a plurality of radial ribs increase the load strength of the cylindrical load-bearing wall.
[0024] Clause 7: A syringe described in any one of clauses 1 to 6, wherein at least one of the plurality of radial ribs extends inwardly from the cylindrical load-bearing wall to the conical distal end wall a different radial distance than the remaining radial ribs of the plurality of radial ribs.
[0025] Clause 8: A syringe described in any one of clauses 1 to 7, wherein the cylindrical load-supporting wall is configured to abut against a retaining surface of the retaining arm of the fluid injector to retain the syringe within the pressure jacket during a pressure injection procedure.
[0026] Clause 9: A syringe according to any one of clauses 1 to 8, wherein the cylindrical load-bearing wall extends axially from the cylindrical side wall of the syringe at an angle of between 1 degree and 30 degrees relative to the longitudinal axis of the syringe.
[0027] Clause 10: A syringe described in any one of clauses 1 to 9, wherein the distal surface of the cylindrical load-bearing wall is radially tapered from a more proximal inner portion to a more distal outer portion relative to the longitudinal axis of the syringe.
[0028] Clause 11: A syringe as described in clause 10, wherein the angle of the distal surface of the cylindrical load-bearing wall is configured to prevent fluid from flowing between the cylindrical side wall of the syringe and the pressure jacket in which the syringe is disposed.
[0029] Clause 12: A syringe as described in clause 10 or 11, wherein the angle of the distal surface of the cylindrical load-bearing wall is configured to increase the radially inward force against the retaining arm of the fluid injector.
[0030] Clause 13: A syringe described in any one of clauses 1 to 12, wherein at least one of the cylindrical load-bearing wall and the plurality of radial ribs enhances a refractive halo effect at a distal portion of the conical distal end wall due to electromagnetic radiation emitted from at least one electromagnetic radiation source within the piston head or plunger head of the fluid injector.
[0031] Clause 14: A syringe described in any one of clauses 1 to 13, further comprising a neck portion connected to a fluid nozzle at a distal end of the syringe, the neck portion including a fluid passage having a plurality of fluid diverting ribs extending at least partially radially inward from an inner surface of the neck portion into the interior of the fluid passage.
[0032] Clause 15: A syringe as described in clause 14, wherein a plurality of fluid diverting ribs are configured to divert fluid flowing through the neck portion within the syringe so that the fluid flows along the inner surfaces of the conical distal end wall and the cylindrical side wall of the syringe.
[0033] Clause 16: A syringe as described in clause 14 or 15, wherein the plurality of fluid diverting ribs are configured to minimize the amount of air bubbles in the fluid within the syringe.
[0034] Clause 17: A syringe as described in clause 16, wherein the amount of air bubbles in the fluid 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.
[0035] Clause 18: A syringe described in any one of clauses 14 to 17, wherein at least some of the plurality of fluid diverting ribs have different shapes.
[0036] Clause 19: A syringe described in any one of clauses 14 to 18, wherein at least some of the plurality of flow diverting ribs extend different distances from the inner surface into the fluid passage.
[0037] Clause 20: A syringe described in any one of clauses 1 to 19, wherein a plurality of radial ribs extend along the conical distal end wall at an angle relative to the longitudinal axis of the syringe such that the distance between each adjacent pair of the plurality of radial ribs gradually decreases from the cylindrical load-bearing wall to the fluid nozzle.
[0038] Clause 21: A syringe comprising: a proximal end, a distal end, and a cylindrical sidewall extending between the proximal and distal ends, the distal end including a conical distal end wall, and a fluid nozzle at a distal end of the conical distal end wall; a plurality of fluid redirecting ribs extending inwardly from an inner surface of the fluid nozzle; and a plurality of radial ribs disposed along a periphery of the conical distal end wall, wherein longitudinal axes of the plurality of radial ribs extend radially inwardly from the cylindrical load bearing wall toward the fluid nozzle across at least a portion of the conical distal end wall.
[0039] Clause 22: The syringe of clause 21, further comprising a cylindrical load-bearing wall extending axially from the cylindrical side wall beyond a proximal end of the conical distal end wall.
[0040] Clause 23: A syringe as described in clause 21 or 22, wherein the plurality of radial ribs define a plurality of fluid retaining grooves between each pair of adjacent radial ribs, the plurality of fluid retaining grooves being configured to retain a volume of fluid by capillary adhesion when the syringe is rotated from a first upward position to a second downward position.
[0041] Clause 24: A syringe as described in clause 23, wherein the plurality of fluid retaining grooves are configured to hold a volume of fluid in the range of 0.1 to 0.8 milliliters.
[0042] Clause 25: A syringe as described in Clause 23, wherein the volume of fluid held by the plurality of fluid retaining grooves is determined at least in part from the distance between each adjacent pair of the plurality of radial ribs, the height of each adjacent pair of the plurality of radial ribs, and the distance each pair of radial ribs extends radially inwardly distally from the conical distal end wall.
[0043] Clause 26: A syringe comprising: a proximal end, a distal end, and a cylindrical sidewall extending between the proximal and distal ends, the distal end including a conical distal end wall, and a fluid nozzle at a distal end of the conical distal end wall; and a plurality of fluid diverting ribs extending inwardly from an inner surface of the fluid nozzle, the plurality of fluid diverting ribs enhancing a refractive halo effect at a distal portion of the conical distal end wall due to electromagnetic radiation emitted from at least one electromagnetic radiation source within a piston head or plunger head of the fluid injector.
[0044] Clause 27: The syringe of clause 26, further comprising a cylindrical load-bearing wall extending axially from the cylindrical side wall beyond a proximal end of the conical distal end wall.
[0045] Clause 28: A syringe as described in Clause 26 or 27, further comprising a plurality of radial ribs arranged along a periphery of the conical distal end wall, the longitudinal axes of the plurality of radial ribs extending radially inward from the cylindrical load-bearing wall toward the fluid nozzle across at least a portion of the conical distal end wall.
[0046] Clause 29: A syringe as described in clause 28, wherein the plurality of radial ribs define a plurality of fluid retaining grooves between each pair of adjacent radial ribs, the plurality of fluid retaining grooves being configured to retain a volume of fluid by capillary adhesion when the syringe is rotated from a first upward position to a second downward position.
[0047] Clause 30: A syringe as described in clause 29, wherein the plurality of fluid retaining grooves are configured to hold a volume of fluid in the range of 0.1 to 0.8 milliliters.
[0048] Clause 31: A syringe as described in Clause 29, wherein the volume of fluid held by the plurality of fluid retaining grooves is determined at least in part from the distance between each adjacent pair of the plurality of radial ribs, the height of each adjacent pair of the plurality of radial ribs, and the distance each pair of radial ribs extends radially inwardly distally from the conical distal end wall.
[0049] The above is a summary and may include simplifications, generalizations, inclusions, and / or omissions of details, and therefore those skilled in the art will appreciate that this summary is illustrative only and is not intended to be limiting in any way. Other aspects, features, and advantages of the apparatus and / or methods described herein and / or other subject matter will become apparent from the disclosure set forth herein. In addition to the exemplary aspects and features described above, further aspects and features will become apparent by reference to the drawings and the following detailed description.
[0050] The novel features described herein are set forth with particularity in the appended claims, however, such features, both as to organization and method of operation, may be better understood by reference to the following description taken in conjunction with the accompanying drawings. [Brief description of the drawings]
[0051] [Figure 1] FIG. 1 is a perspective view of a syringe according to one embodiment of the present disclosure. [Diagram 2] FIG. 2 is a side view of the syringe of FIG. 1. [Diagram 3] 2 is a cross-sectional view of the syringe of FIG. 1 taken along line AA. [Figure 4] FIG. 2 is a top view of the syringe of FIG. 1. [Diagram 5] FIG. 13 is a perspective view of a syringe according to another embodiment of the present disclosure. [Figure 6]FIG. 13 is a perspective view of a syringe according to another embodiment of the present disclosure. [Figure 7A] FIG. 2 is a cross-sectional view of a syringe held within a holding device according to one embodiment of the present disclosure. [Figure 7B] 7B is a cross-sectional view of the syringe of FIG. 7A being inserted into a retaining device. [Figure 8] FIG. 2 is a side view of a syringe according to one embodiment of the present disclosure. [Figure 9] FIG. 9 is an enlarged side view of the distal tip of the syringe of FIG. 8. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0052] In the following detailed description, reference is made to the accompanying drawings, which form a part of this specification. The exemplary features shown and described in the detailed description, drawings, and claims are not intended to be limiting. Other features may be utilized, and other changes may be made, without departing from the scope of the subject matter presented herein.
[0053] Before describing the various aspects of the syringe assembly and its various features in detail, it should be noted that the various aspects disclosed herein are not limited in their application or use to the details of construction and arrangement of parts shown in the accompanying drawings and description. Rather, the disclosed devices may be arranged or incorporated in other devices, variations and modifications thereof, and may be implemented or performed in various ways. Thus, the aspects of the syringes and syringe features disclosed herein are exemplary in nature and are not intended to limit the scope or application thereof. Furthermore, unless otherwise indicated, the terms and expressions used herein have been selected for the purpose of describing the various aspects of the syringes and syringe features for the convenience of the reader, and are not intended to limit the scope thereof. Furthermore, it should be understood that any one or more of the components, expressions, and / or examples of the syringes and syringe features may be combined with any one or more of the other components, expressions, and / or examples thereof without limitation.
[0054] It should also be understood that in the following description, terms such as front, rear, inside, outside, top, bottom, etc. are terms of convenience and should not be construed as limiting terms. As used herein, the term "proximal" when used to describe a portion of a syringe is generally used to indicate the portion of the syringe closer to the injector, and the term "distal" when used to describe a portion of a syringe is generally used to indicate 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, inasmuch as the device described herein or portions thereof may be attached or utilized in other orientations. Various aspects of the syringe and syringe features are described in more detail with reference to the drawings.
[0055] The present disclosure relates to syringe designs for use in powered fluid injectors used in medical imaging procedures. According to various embodiments, certain medical imaging procedures may include the injection of a contrast agent or contrast medium to enhance certain features in a medical image. The process known as medical imaging with contrast medium typically involves the injection of the contrast medium with a suitable flushing medium, such as saline, before or during the imaging process. Powered fluid injectors are used to control the injection of fluids and are typically designed with one or more syringes for holding and dispensing the contrast medium, flushing fluids, and other medical fluids administered before or during the imaging procedure. For example, U.S. Patent Nos. 5,383,858, 6,652,489, 7,563,249, 8,945,051, 9,173,995, and 10,507,319 disclose front-loading syringes and powered injectors, both with and without pressure jacketing, the disclosures of which are incorporated herein by reference.Common medical imaging procedures that use contrast agents include computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET, SPECT), and angiography (CV). Due to viscosity and the need to deliver large volumes of contrast agent in a short period of time through small diameter tubing sets and / or catheters to provide a "tight bolus," 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. The injector may be configured to inject or expel the fluid medium contained in the first syringe, the second syringe, and / or the additional syringe in a controlled manner, such as may be used in medical procedures such as angiography, CT, PET, and NMR / MRI.
[0056] Many potential problems can occur during the injection process that should or must be avoided, such as difficulty or delay in loading the syringe into the pressure jacket, deformation or breakage of the syringe due to high injection pressures or disengagement of the syringe from the fluid injector, dripping of contrast or saline that can contaminate one or more surfaces of the syringe or injector components, entrapment of air in the syringe and potentially injecting it into the patient, slow fill rates due to air bubble formation, inability to see the syringe contents, among other problems. The syringes and features described herein reduce 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 shown in FIGS. 1-3. In various embodiments of the present disclosure, the syringe 2 may include an embodiment of a tube clip or spike clip 16 as described in International Application PCT / US2021 / 018523, the disclosure of which is incorporated herein by reference in its entirety. 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 certain embodiments, the syringe 2 may include a cylindrical load-bearing wall 18 extending distally from the cylindrical side wall 8 beyond the proximal end 20 of the conical distal wall 14. The cylindrical load-bearing wall 18 may project along the longitudinal axis L and provide a distal surface 22 configured to abut the inner proximal surface 100 of one or more retaining elements 102 at the distal end of one or more retaining arms 103 (see FIGS. 7A and 7B) to retain the syringe 2 within the pressure jacket, keep the syringe 2 engaged with the fluid injector, and support loads associated with the delivery of pressurized fluid (e.g., loads generated by the motor of the fluid injector when pressurizing the fluid using a motorized piston). For example, in a CT injection protocol, the cylindrical load-bearing wall 18 may be configured to support loads of at least 300 psi. According to other embodiments during a CV injection protocol, the cylindrical load-bearing wall 18 may be configured to support loads associated with the high pressures of angiographic injection. For example, in certain angiographic injections, the fluid in the syringe 2 may be pressurized up to 1200 psi. High pressure may be required to deliver viscous contrast media or low viscosity saline through small diameter catheters typically associated with CV injection procedures. When the cylindrical load-bearing wall 18 abuts against the inner wall of the distal end of the pressure jacket, the load from the syringe 2 is transferred to one or more retention elements 102 at the distal end of one or more retention arms 103 and ultimately to the frame mechanism of the fluid injector. The cylindrical load-bearing wall 18 may be continuous along the circumference of the distal end 6 of the syringe 2 or may be discontinuous. In certain embodiments, the cylindrical load-bearing wall 18 is continuous along the circumference of the distal end 6 of the syringe 2.
[0059] In certain embodiments, the cylindrical load bearing wall 18 extends from the cylindrical side wall 8 and flares toward the distal end such that the distal outer diameter of the load bearing wall 18 is greater than the outer diameter of the cylindrical side wall 8, as shown in Figures 2 and 3. According to certain embodiments, the cylindrical load bearing wall 18 may flare at an angle of 1° to 30° relative to the longitudinal axis L of the syringe 2. The flared cylindrical load bearing wall 18 may facilitate easy installation of the syringe 2 into the pressure jacket 104 and may allow the syringe 2 and corresponding plunger to engage with a piston of a fluid injector. Specifically, the flared surface 19 flares from the outer surface of the cylindrical side wall 8 to the distal surface 22 of the load bearing wall 18. For example, as shown in Figures 7A and 7B, when a syringe is lowered into the pressure jacket over the one or more retaining elements 102, the flared cylindrical load bearing wall 18 can press the one or more retaining elements 102 and corresponding retaining arms 103 outward. A user may apply a certain amount of downward force (e.g., the fluid injector and pressure jacket assembly may be in a vertical position with the open end of the pressure jacket facing vertically upward) to allow the downward force to move the one or more retaining elements 102 outward against the biasing restoring force. Once the distal-most end of the cylindrical load bearing wall 18 is pressed over the inner proximal surface 100 of the one or more retaining elements 102, the biasing restoring force may pull the one or more retaining elements 102 back to an initial position where the inner proximal surface 100 of the one or more retaining elements 102 abuts against the distal sloped surface of the cylindrical load bearing wall 18 when the syringe 2 and plunger are placed under load by the piston of the fluid injector. In this manner, a laboratory technician can load the syringe 2 into the injector by simply applying a downward force to the syringe 2 until it engages the pressure jacket assembly. In certain embodiments, an audible indication, such as a click or snap, may be provided as the one or more retention elements snap close to indicate that the syringe is properly loaded. The snap closure may also provide a visual indication to the laboratory technician that the syringe is properly loaded.Removal of the syringe 2 may be effected by outward movement of one or more holding elements 102 and corresponding holding arms 103, either manually by a laboratory technician or by a motor of the injector. Suitable embodiments of holding arm mechanisms are described in International Application PCT / US2020 / 049885, the disclosure of which is incorporated herein by this reference.
[0060] In various embodiments, the outer diameter of the flared cylindrical load bearing wall 18 tightly abuts the pressure jacket 104 and / or the sidewall of the one or more retention elements 102, which can substantially prevent leaking medical fluid, such as contrast or saline, from flowing between the cylindrical sidewall 8 of the syringe 2 and the pressure jacket 104 (see FIG. 7A). In certain embodiments, pressurization of the syringe 2 and associated compliance due to expansion of the sidewall 8 and distal end wall 14 of the syringe 2 under pressure can further secure the cylindrical sidewall 8 of the syringe 2 against the pressure jacket 104 and / or the one or more retention elements 102, further enhancing the sealing interaction. According to various embodiments, an elastomeric coating or material may be applied to the inner proximal surface 100 of the one or more retention elements 102 and / or the distal surface 22 of the cylindrical load bearing wall 18 to form a fluid-tight seal therebetween when the syringe is tightly abutted against the one or more retention elements 102.
[0061] 1-4, the distal end 6 of the syringe 2 may further include a plurality of radial ribs 24 disposed along the periphery of the conical distal end wall 14. The plurality of radial ribs 24 extend inwardly 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 slightly apart along the conical distal end wall 14, for example, less than 1.5 cm apart. If shorter radial ribs 24 are used, a user may more easily identify one or more air bubbles in the syringe 2 because the radial ribs 24 do not significantly obstruct the user's view into the syringe 2 when, for example, the fluid injector is in an upright vertical position and the natural buoyancy of the one or more air bubbles causes the air bubbles to rise toward the distal end of the conical end wall 14. According to various embodiments, the plurality of radial ribs 24 define a plurality of fluid retention grooves 26 therebetween. Each fluid retention groove 26 may be disposed between each pair of adjacent radial ribs 24. The plurality of fluid retention grooves 26 may be configured to hold a volume of fluid previously dripped from the fluid nozzle 10. For example, when the syringe 2 rotates from a first vertically upward position to a second tilted downward position, the fluid within the fluid retention grooves 26 is retained within the fluid retention grooves 26. Capillary adhesion (also known as capillary action) and surface tension of the fluid may hold the volume of fluid within the plurality of fluid retention grooves 26 against gravity. Additionally, the plurality of radial ribs 24 may abut against an inner wall of the cylindrical load-bearing wall 18 to further retain the fluid. For example, in certain embodiments, the syringe 2 may be filled with a fluid, such as contrast agent, saline, or other medical fluid, with the injector head and distal end 6 of one or more syringes 2 positioned in an upright position, for example to facilitate filling the fluid via a spike and / or to control and visualize the amount of air entrapped in the syringe 2 during the injection process.In certain embodiments, a small amount of fluid may seep or drip from the fluid nozzle 10 of the syringe 2, such as during filling via the spike or fluid passage, switching between the fluid filling passage and the fluid delivery passage, or purging of air, or when the spike or fluid passage is removed after filling or purging.
[0062] In many conventional fluid injection procedures, after an injection process in an upright configuration, the injector head may be rotated such that the distal end 6 of one or more of the syringes 2 is tilted downward to ensure that any air that may remain in the syringe 2 is lifted by buoyancy to the proximal end 4 of the syringe 2, thereby reducing the risk of air injection or embolism. In conventional syringe designs, the volume of fluid that is dispensed may run down the exterior surface of the syringe and adhere to or contaminate various surfaces of the fluid injector. In certain instances, small amounts of fluid may drip from the syringe onto the floor, creating a hazard for the technician and patient, and / or contaminating various surfaces within the fluid injection chamber. Additionally, many contrast media are sticky, viscous solutions that may build up a sticky coating on floors and other surfaces, creating a safety hazard and further increasing unwanted contact with contrast media or other medical fluids, potentially requiring additional cleaning procedures.
[0063] According to various embodiments, the plurality of fluid retention grooves 26 may be configured to retain the volume of fluid dripped from the fluid nozzle 10, for example, by capillary adhesion or capillary action between adjacent radial ribs 24. As shown in FIG. 4, the gap widths between adjacent radial ribs 24 may be referred to as d1, d2, 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. For the latter embodiment, the gap width may be such that d1 < d2 < d3, or d1 > d2 > d3, or the appropriate gap width is not limited to these and may be determined in some other way. In various embodiments, since the adjacent radial ribs 24 are arranged radially, the gap width may increase as it radially separates from the longitudinal central axis L of the syringe 2. Alternatively, the gap width may remain constant by increasing the width of the radial ribs 24 as it radially separates from the central axis. According to various embodiments, the distance between two adjacent radial ribs 24 that define the gap (i.e., "d") associated with the fluid retention groove 26 may be in the range of 0.01 inches to 0.25 inches. Further details regarding capillary action are described in International Publication No. WO 2017 / 091636, the disclosure of which is incorporated herein by reference.
[0064] According to certain embodiments, the plurality of fluid retaining grooves 26 can hold a maximum flow rate of fluid in the range of 0.1 mL to 0.8 mL when the syringe 2 rotates from the first upward position to the second tilted downward position. In other embodiments, the maximum flow rate of fluid may be adjusted by varying the height of the plurality of radial ribs and / or varying the distance between adjacent radial ribs. In certain embodiments, the capillary volume of fluid held by adjacent radial ribs 24 is determined at least in part from the distance between each adjacent pair of the plurality of radial ribs 24, the height of each adjacent pair of the plurality of radial ribs 24, and the distance each adjacent pair of radial ribs 24 extends radially inwardly and distally along the conical distal end wall 14. That is, the volume of fluid may be determined by one or more of the distance between adjacent pairs of radial ribs 24, the depth of the fluid retaining groove 26 between adjacent pairs of radial ribs 24, or the length of the adjacent pairs of radial ribs 24 or the length of the associated fluid retaining groove 26.
[0065] At least a portion of the plurality of radial ribs 24 extend across the conical distal end wall 14 at different distances from the cylindrical load bearing wall 18. For example, in FIG. 4, the plurality of radial ribs 24 may extend across a portion of the conical distal end wall 14 from the cylindrical load bearing wall 18 of the syringe 2. In other embodiments, as shown in FIG. 5, the plurality of radial ribs 24 may extend from the cylindrical load bearing wall 18 of the syringe 2 to the conical distal end wall 14 toward the fluid nozzle 10 of the syringe 2.
[0066] 5, the radial ribs 24 may extend different distances from the cylindrical load-bearing wall 18, and some of the radial ribs 24 may have different heights compared to others of the radial ribs 24 (see FIG. 5). As seen in these figures, in various embodiments, the radial ribs 24 abut against the cylindrical load-bearing wall 18 of the syringe 2 to form a reservoir at the distal end 6 of the syringe 2 that helps direct medical fluid into the fluid-retaining groove 26 and, as a fluid-retaining wall, provides additional capacity for retaining fluid within the reservoir with the cylindrical load-bearing wall 18.
[0067] 6, the plurality of ribs 24 may be annular and may be concentrically disposed along the conical distal end wall 14. A concentric annular rib 28 may be disposed from the cylindrical load-bearing wall 18 of the syringe 2 toward the fluid nozzle 10.
[0068] In various embodiments, including the syringe 2 shown in FIGS. 1-6, the radial ribs 24 and / or annular ribs 28 can increase the load strength of the conical distal end wall 14. For example, the radial ribs 24 or annular rib 28 can increase the thickness of the conical distal end wall 14 where the radial ribs 24 or annular rib 28 are located, thereby increasing the strength of the conical distal end wall 14. In various embodiments, the increased wall strength can withstand and help limit increased compliance of the conical distal end wall 14 during pressurized fluid injection procedures. According to various embodiments, the increased thickness of the conical distal end wall 14 where the radial ribs 24 or annular rib 28 are located can reduce the need for pressure jacket reinforcement at the conical distal end wall 14. 7A, the pressure jacket 104 may be generally cylindrical and abut against the syringe retaining element 102, and the conical distal end wall 14 of the syringe 2 may be able to withstand high injection pressures (up to 1200 psi) without reinforcement from the pressure jacket 104 and / or the syringe retaining element 102. This allows the user to easily visualize the conical distal end wall 14, for example, to check the fill status of the fluid volume and the presence of one or more air bubbles within the syringe 2.
[0069] In certain embodiments, the plurality of radial ribs 24 can increase the load strength of the cylindrical load bearing wall 18. For example, the plurality of radial ribs 24 abut and connect 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. Also, connecting the plurality of radial ribs 24 to the cylindrical load bearing wall 18 can increase the load strength of the cylindrical load bearing wall 18 by preventing the cylindrical load bearing wall 18 from deforming or bowing inwardly or outwardly when a pressure load is applied to the syringe 2.
[0070] As shown in FIGS. 3 and 8, according to one embodiment of the present disclosure, the proximal end 4 of the syringe 2 may have a diameter D1 that is wider than the diameter D2 of the remaining portion of the cylindrical sidewall 8. In this example, the "working area" 7 of the syringe 2, where the plunger 106 is forced through the fluid passageway of the cylindrical sidewall 8, may have a smaller diameter D2 compared to the diameter D1 of the "plunger receiving area" 5 of the proximal end 4. According to this embodiment, the plunger receiving area 5 is the area of the syringe where the plunger is placed during manufacturing and storage, and the wider diameter D1 prevents the outer periphery of the plunger's rubber cover from being compressed during shipping and storage. This ensures a fluid-tight seal between the syringe sidewall 8 and the plunger's rubber cover as the plunger moves from the wider diameter D1 of the receiving 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 in which the syringe 2 is held can measure the force on the piston motor associated with moving the plunger 106 through the fluid passage of the syringe 2, specifically the additional force required to move the plunger 106 from the wider diameter D1 of the containment area 5 to the narrower diameter D2 of the working area 7 of the syringe 2. The fluid injector can measure the size of the syringe 2 being used in the fluid injector based on the force applied by the fluid injector to the piston. For example, for 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 containment area 5 having a diameter D1 to the working area 7 having a diameter D2. Because D1 is greater than D2, less force is required to move the piston through the proximal end 4 of the syringe 2 than through the working area 7 of the syringe 2. Thus, the fluid injector may calibrate the piston position when the plunger 106 is pressed into the working area 7 of the syringe 2 based on the change in force applied to the piston as it moves from the receiving area 5 of diameter D1 at the proximal end 4 to the working area 7 of diameter D2.For a longer, larger capacity syringe having a wider working area 7, the change in force applied to the piston will occur at a given piston position depending on the proximity of the proximal end 4 of the syringe 2 to the injector head, whereas for a shorter, smaller capacity syringe (e.g., 100 mL or 50 mL) having a narrower working area 7 located further distally within the pressure jacket (i.e., when the distal end 6 of the syringe 2 abuts the syringe retaining element 102), the change in force applied to the piston will occur at a given piston position when the piston extends further along the piston passage, which corresponds to the fact that the proximal end 4 of the syringe 2 and the plunger are spaced farther away from the injector head in the initial position.
[0071] The fluid injector records the location where the force applied to the piston changes due to the plunger moving from the containment area 5 to the actuation area 7, allowing the injector to measure the length, and therefore the volume, of the syringe loaded in the pressure jacket and make various adjustments to any injection procedure set up according to this information. Furthermore, if the fluid injector determines that no change in the piston force has occurred or that there is a deviation in the location where the force change is expected to occur, the fluid injector can stop the fluid injection procedure and notify the laboratory technician that an error has occurred. For example, if a syringe is inadvertently reused, the fluid injector can notify the laboratory technician to prevent inadvertent reuse of the syringe, since the plunger is likely not in the initial containment area 5 and is not in the location where the force change is expected to occur. Similarly, if the plunger is unintentionally moved into the actuation area 7, for example during shipping, the fluid injector can determine that no change in force has occurred and prevent use of a syringe that may have been damaged (e.g., the fluid seal between the plunger and the syringe sidewall may be compromised).
[0072] In other embodiments, as shown in FIG. 7A, the cylindrical load bearing wall 18 may have a distal surface 22 configured to interface and abut a proximal surface 100 of a syringe-holding element 102 of a syringe-holding arm 103 of a fluid injector. According to certain embodiments, the distal surface 22 of the cylindrical load bearing wall 18 may be radially angled such that an inner periphery of the distal surface 22 is proximal along the longitudinal axis relative to an outer periphery of the distal surface 22. According to this embodiment, the corresponding proximal surface 100 of the syringe-holding element 102 is radially angled in approximately the same direction as a complementary 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 range from 1° to 89°, and in certain embodiments may range from 1° to 30°, with the angle of the corresponding proximal surface 100 being complementary. Thus, when 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 retaining element 102 when the syringe 2 is under load during the delivery process, the two surfaces 22 and 100 interact as the pressurized syringe 2 is urged distally along the longitudinal axis L, thereby establishing a retention force on the retaining arms 103 that urges the retaining arms 103 radially inward to maintain the closed configuration. Thus, the force retaining the syringe 2 within the pressure jacket 104 and the retention mechanism of the fluid injector increases during pressurized delivery of fluid during a contrast injection procedure. In one non-limiting example, the cylindrical load bearing wall 18 may be configured to move the retaining arms 103 outward when the syringe 2 is inserted into the fluid injector, thereby opening the retaining arms 103 and allowing the syringe 2 to move into the fluid injector. After the syringe 2 has passed through the syringe retaining element 102, the retaining arms 103 may be configured to move inwardly closer to one another to retain the syringe 2 within the fluid injector.
[0073] As described in U.S. Pat. No. 10,420,902, the disclosure of which is incorporated by reference herein and shown 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 can be visualized by the presence or absence of halo illumination 40a at the conical distal end 6 of the syringe 2. For example, electromagnetic radiation may be reflected off a colored surface or shown through a translucent or transparent plunger cap (from a light source within the piston head). When the syringe 2 is completely filled with liquid fluid, electromagnetic radiation refracts off the syringe sidewall 8 and the conical distal end wall 14 to show a refractive halo effect in the form of halo illumination 40a occurring near the periphery of the distal portion of the conical distal end 6 of the syringe 2. In the presence of a small amount of air (e.g., up to 5 mL or more), no halo illumination 40a is observed. This provides a way for the technician to visually determine if air is present in the syringe 2 and perform a purging / priming operation to remove the air and prevent the injection of air into the patient. In certain embodiments, the visualization process may also be performed by the injector if equipped with an appropriate camera and associated software. According to various embodiments of the present disclosure, at least one of the cylindrical load-bearing wall 18 or the plurality of radial ribs 24 may increase the amount of electromagnetic radiation that refracts at the distal end 6 of the syringe 2 when the syringe 2 is filled with fluid. For example, the plurality of radial ribs 24 may function similarly to a Fresnel lens, increasing the reflection and refraction of electromagnetic radiation to create a brighter halo illumination near the outer periphery of the distal portion of the conical distal end 6 of the syringe 2. In other embodiments, electromagnetic radiation may also reflect from the conical distal end to illuminate a halo 40b near at least a portion of the cylindrical load-bearing wall 18, such as near the plurality of radial ribs 24. In certain embodiments, the electromagnetic radiation may be emitted from at least one electromagnetic radiation source in the piston head of the fluid injector, hi other embodiments, the electromagnetic radiation may be reflected from at least a portion of a 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 the flow of fluid into and out of the syringe 2 during fluid injection and delivery processes. According to various embodiments, the syringe 2 may include a neck connected to a fluid nozzle 10 at a distal end 6 of the syringe 2. The neck may include a larger diameter than a conventional syringe, for example to include a connector element as described in International Application PCT / US2021 / 018523. The neck of the syringe 2 may include a fluid passageway having a plurality of fluid diverting ribs 30 extending at least partially radially inwardly from an inner surface of the neckway into the interior of the fluid passageway, as shown in FIGS. 3 and 4.
[0075] According to various embodiments, the plurality of fluid diverting ribs 30 may divert fluid flowing through the fluid nozzle 10 during an injection procedure into the syringe 2 such that the fluid flows along the inner surface of the conical distal end wall 14 and cylindrical side wall 8 of the syringe 2. In certain embodiments, the plurality of fluid diverting ribs 30 may include ribs that extend radially inwardly at different distances (compare rib 30 and rib 31 in FIG. 4 ) and / or extend different lengths along the longitudinal axis L of the fluid nozzle 10. While not intending to be limited by any interpretation, it is believed that the redirection of fluid flow through the syringe fluid nozzle 10 is the result of the Coanda effect, where the fluid diverting ribs 30 cause the fluid to adhere to the inner sidewall of the conical distal end wall 14 and cylindrical side wall 8 of the syringe 2. For example, capillary adhesion of the fluid to the walls of the fluid diverting ribs 30 may cause the fluid to be held against the inner sidewall of the neck by surface tension and continue into the inner sidewall of the conical distal end wall 14 and cylindrical sidewall 8. Having the fluid flow down along the inner sidewall of the syringe instead of flowing into the syringe without contacting the inner sidewall results in fewer air bubbles being generated in the fluid during the injection procedure. In contrast, in a conventional syringe without the fluid diverting ribs 30, the fluid may flow / drip down the center of the syringe fluid nozzle 10 and then drip onto the plunger 106 forming air bubbles in the fluid. These air bubbles may adhere to the plunger 106 and sidewall surfaces and are typically difficult to remove during the priming procedure. The resulting air bubbles may increase the risk of air embolism from small amounts of air injection, especially in angiography procedures. As mentioned above, air bubble formation within the syringe and / or fluid passageways must be avoided to prevent air embolism, especially during high pressure CV imaging procedures. According to these embodiments, the fluid diverting ribs 30 minimize the amount of air bubbles in the fluid within the syringe 2. Previous work has shown that a fluid diverter in the center of the flow path through the nozzle reduces air bubble formation during filling, see, for example, WO 2017 / 0914643, the disclosure of which is incorporated herein by reference.The described fluid diverting ribs 30 provide a similar effect without the need for a fluid diverter mechanism in the flow path, thereby simplifying the manufacturing and injection molding of the syringe 2. The amount of air bubbles in the fluid in the filled syringe 2 may be minimized by having the fluid flow along the inner surface of the distal end wall 14 and cylindrical side wall 8 of the syringe 2, rather than dripping / flowing directly from the syringe fluid nozzle 10 onto the plunger surface. In one embodiment of the present disclosure, the fluid diverting ribs 30 may also identify the presence of air bubbles in the syringe 2 by enhancing the circumferential halo lighting effect described herein. As observed with the plurality of radial ribs 24, the fluid diverting ribs 30 may spread and further reflect / refract the incident electromagnetic radiation, increasing the brightness of the halo lighting observed near the periphery of the distal portion of the conical distal end 6 of the syringe 2. In certain embodiments, at least some of the plurality of fluid diverting ribs 30 may have different cross-sectional shapes. In other embodiments, at least some of the plurality of fluid diverting ribs 30 may extend different distances from the inner surface of the fluid nozzle 10 into the distal portion of the conical distal end 6 of the syringe 2 .
[0076] According to various embodiments, the plurality of fluid diverting ribs 30 may also increase the fill speed, potentially due to increased laminar flow of fluid into the syringe 2 as the fluid passes through the fluid diverting ribs 30. As a result, the syringe may be filled more quickly than a conventional syringe, which may substantially reduce the time between procedures. Additionally, the fill speed may be increased due to reduced bubble formation during filling, which may result in a reduced prime volume and therefore less waste fluid generated with larger prime volumes.
[0077] According to various embodiments, the features described herein can enhance the ease of injection molding of the syringe 2. For example, the syringe 2 can be formed from medical grade plastics such as PET, polycarbonate, polyethylene, and blends thereof, and can be formed into a syringe shape by an injection molding process. During injection molding, the features can cause problems during removal of the article from the mold, such as processing undercuts due to the features. Furthermore, certain features can require expensive mold configurations specific to those features that can still result in high reject rates. According to various embodiments of the syringe 2 and the features described therein, the configuration of the plurality of radial ribs 24, the fluid diverting ribs 30, and the cylindrical load bearing wall 18 can eliminate processing undercuts from the injection mold for injection molding the syringe 2.
[0078] Several beneficial features of the syringe 2 are described in this disclosure. However, various combinations of the described features may be incorporated into the syringe as required by the intended use of the syringe and the characteristics of the fluid injector. For example, the syringe may include at least one of these features and may include various other features as desired. For example, according to one embodiment, the syringe may include a plurality of radial ribs 24 along the periphery of the conical distal end wall 14 and a cylindrical load bearing wall 18, but may not include a plurality of fluid diverting ribs 30, as described herein. For example, according to one embodiment, the syringe may include a plurality of radial ribs 24 along the periphery of the conical distal end wall 14 and a cylindrical load bearing wall 18, but may not include a plurality of fluid diverting ribs 30, as described herein. For example, according to one embodiment, the syringe may include a plurality of cylindrical load bearing wall 18 and a plurality of fluid diverting ribs 30, but may not include a plurality of radial ribs 24, as described herein. Accordingly, the various embodiments detailed herein and illustrated in the accompanying drawings are intended to be illustrative only and in no way limiting of the features incorporated in the present syringe.
[0079] Although the various aspects and features of the syringe assembly are described in connection with a syringe for a medical power injector, the syringe assembly and various features described herein may also be incorporated into a handheld syringe that delivers fluids at low injection pressures. For example, in many medical settings where fluids are injected by handheld syringes, a physician may aspirate fluid into the syringe from a corresponding fluid container, such as a vial, and then prime or purge the syringe by holding the syringe in a vertical position and depressing the plunger assembly to deliver a small amount of fluid along with any air contained within the syringe. The ejected fluid may drip down the sides of the needle and syringe body, thus potentially bringing the physician into contact with the medical fluid. The syringe assembly and various features described herein may be utilized on handheld syringes to prevent fluid from dripping and contacting the physician or dripping onto surfaces, whether dripping of ejected fluid during the priming process or dripping of fluid during the injection process. Various embodiments of the present syringe assembly and handheld syringes comprising various features are within the scope of this disclosure.
[0080] Yet another aspect of the present disclosure relates to other medical devices that include the syringe assemblies and various features described herein. For example, any medical device that delivers fluid that may include small amounts of fluid leakage or dripping from a fluid opening onto its surface can benefit from the fluid wicking flanges of the present disclosure. Examples of such medical devices include, but are not limited to, catheters (such as the distal end or the portion placed just outside the patient's body), tubing sets, intravenous lines, tube connectors and tube clips, shunts, fluid manifolds, valves, suction tubing, surgical instruments, fluid pump outputs, and the like, all of which may be modified to include various features described herein.
[0081] It is worth pointing out that reference to "one aspect" or "an aspect" means that the particular features, structures, or characteristics described in connection with that aspect are included in at least one aspect. Thus, the appearances of the phrases "in one aspect" or "in an aspect" in various places throughout this specification are not necessarily all referring to the same aspect. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more aspects.
[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 to clarify concepts, and various configuration variations are contemplated. Thus, as used herein, the specific examples described and the accompanying descriptions are intended to represent their more general classification. In general, the use of any specific example is intended to represent that classification, and should not be construed as limiting by not including specific components (e.g., operations), devices, and objects.
[0083] When any plural and / or singular terms are used herein, those of skill in the art can convert from plural to singular and / or from singular to plural as appropriate to the context and / or application. The various singular / plural permutations have not been explicitly set forth herein for the sake of brevity.
[0084] The subject matter described herein may depict different components contained within or connected with other different components. It should be understood that the architectures depicted are merely exemplary, and that in fact many other architectures that achieve the same functionality may be implemented. In a conceptual sense, any arrangement of components that achieves the same functionality is effectively "associated" such that the desired functionality is achieved. Thus, any two components herein that are combined to achieve a particular functionality may be considered to be "associated with" one another such that the desired functionality is achieved, regardless of the architecture or intermediate components. Similarly, any two components so associated may also be considered to be "operably connected" or "operably coupled" to one another to achieve the desired functionality, and any two components that can be so associated may also be considered to be "operably couplable" to one another to achieve the desired functionality. Examples of operably coupleable include, but are not limited to, physically matable and / or physically interacting components, and / or wirelessly interactable and / or wirelessly interacting components, and / or logically interactable and / or logically interacting components.
[0085] Some embodiments may be described using the terms "coupled" and "connected," along with their derivatives. It should be understood that these terms are not intended as synonyms for each other. For example, some embodiments may be described using the term "connected" to indicate that two or more elements are in direct physical or electrical contact with each other. In another example, some embodiments may be described using the term "coupled" to indicate that two or more elements are in direct physical or electrical contact with each other. However, the term "coupled" 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 being "configured to," "operative," or "adapted." Those skilled in the art will recognize that "configured to" may generally encompass active components, and / or inactive components, and / or standby components, unless the context requires otherwise.
[0087] Although specific aspects of the subject matter described herein have been shown and described, it will be apparent to one skilled in the art that, based on the disclosure herein, changes and modifications may be made without departing from the subject matter described herein and its broader aspects, and therefore, the appended claims encompass within their scope all such changes and modifications that are within the scope of the subject matter described herein. In general, it will be understood by one skilled in the art that the terms used in this specification, and particularly in the appended claims (e.g., the body of the appended claims), are generally intended as open terms (e.g., the term "including" should be interpreted as "including but not limited to", the term "having" should be interpreted as "having at least", and the term "include" should be interpreted as "include but not limited to"). It will be further understood by one skilled in the art that if the inclusion of a specific number of claim recitations is intended, such intention will be expressly set forth in the claims, and that in the absence of such recitations, no such intention is present. For example, to aid in understanding, the following appended claims may include the use of the introductory phrases "at least one" and "one or more" to introduce claim recitations.However, the use of such phrases should not be construed as meaning that introducing a claim recitation with the indefinite article "a" or "an" limits any particular claim that includes such an introduced claim recitation to claims that include only one of such recitations, even when the same claim includes the introductory phrase "one or more" or "at least one" and an indefinite article such as "a" or "an" (e.g., "a" and / or "an" should typically be construed to mean "at least one" or "one or more"), and the same applies to the use of definite articles used to introduce claim recitations.
[0088] In addition, even if a particular number of claim recitations is explicitly stated, one of ordinary skill in the art will recognize that such a statement should typically be interpreted to mean at least the number recited (e.g., "two recitations" without other modifiers is a straightforward recitation and typically means at least two recitations, or two or more recitations). Furthermore, when a phrase similar to "at least one of A, B, and C, etc." is used, such a configuration is generally contemplated in the sense that one of ordinary skill in the art would understand the phrase (e.g., "a system having at least one of A, B, and C" includes, but is not limited to, a system 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, when phrases similar to "at least one of A, B, and C, etc." are used, such a configuration is generally contemplated in the sense that one of skill in the art would understand the phrase (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.). It will be further understood by those of skill in the art that disjunctive words and / or phrases, whether in the specification, claims, or drawings, which typically present two or more alternative terms, should be understood to consider the possibility of including one of the terms, either of the terms, or both terms, unless the context dictates otherwise. For example, the phrase "A or B" is understood to include the possibility of "A" or "B" or "A and B."
[0089] In summary, many advantages have been described that arise from using the concepts described herein. The above disclosure has been presented for purposes of illustration and description. It is not intended to be exhaustive or limited to the precise form disclosed. Modifications or variations are possible in light of the above disclosure. It is intended that the claims presented herewith define the entire scope of the present disclosure. [Explanation of symbols]
[0090] 2 Pressure Syringes 4 Proximal end 5 Plunger Receiving Area 6 Conical Distal End 7 Syringe Working Area 8 Cylinder side wall, syringe side wall 10 Syringe Fluid Nozzle 12 Distal end 14 Conical Distal End Wall 16 Tube clips or spike clips 18 Cylindrical load-bearing wall 19 Flare Surface 20 Proximal end 22 Distal surface 24 Radial Ribs 26 Fluid retention groove 28 Circular Rib 30 Fluid Diversion Rib 31 Fluid Diversion Rib 40a Halo Lighting 40b Hello 100 Medial proximal surface 102 Syringe Retaining Element 103 Syringe holding arm 104 Pressure Jacket 106 Plunger D1 diameter D2 diameter d1 Gap width d2 Gap width d3 Gap width L Longitudinal axis (longitudinal central axis)
Claims
1. a proximal end, a distal end, and a cylindrical sidewall extending between the proximal end and the distal end, the distal end including a conical distal end wall and a fluid nozzle at a distal end of the conical distal end wall; a cylindrical load bearing wall extending axially from the cylindrical side wall beyond the proximal end of the conical distal end wall, the cylindrical load bearing wall extending axially from the cylindrical side wall of the syringe and extending radially outward from the cylindrical side wall of the syringe at an angle between 1 degree and 30 degrees relative to a longitudinal axis of the syringe; a plurality of radial ribs disposed along a periphery of the conical distal end wall, the longitudinal axes of the radial ribs extending radially inward from the cylindrical load bearing wall toward the fluid nozzle across at least a portion of the conical distal end wall; A syringe comprising:
2. 2. The syringe of claim 1, wherein the plurality of radial ribs define a plurality of fluid retention grooves, a fluid retention groove of the plurality of fluid retention grooves disposed between each pair of adjacent radial ribs of the plurality of radial ribs, and the plurality of fluid retention grooves configured to hold a volume of fluid by capillary adhesion.
3. 3. The syringe of claim 2, wherein the volume of fluid held by the plurality of fluid retaining grooves is between 0.1 and 0.8 milliliters.
4. The syringe of claim 1 , wherein the plurality of radial ribs increase the load strength of the conical distal end wall.
5. The syringe of claim 1 , wherein the plurality of radial ribs increase the load strength of the cylindrical load bearing wall.
6. 10. The syringe of claim 1, wherein the cylindrical load-bearing wall is configured to abut a retention surface of a retention arm of a fluid injector to retain the syringe within a pressure jacket during a pressure injection procedure.
7. 2. The syringe of claim 1, wherein a distal surface of the cylindrical load-bearing wall is radially tapered from a more proximal inner portion to a more distal outer portion relative to a longitudinal axis of the syringe.
8. 8. The syringe of claim 7, wherein the angle of the distal surface of the cylindrical load-bearing wall is radially inclined, whereby the distal surface is complementary to a retaining surface of a retaining arm of a fluid injector such that the distal surface abuts the retaining surface, and the syringe is configured to prevent fluid from flowing between a cylindrical side wall of the syringe and a pressure jacket in which the syringe is disposed.
9. 8. The syringe of claim 7, wherein the angle of the distal surface of the cylindrical load bearing wall is configured to provide a large radially inward force against a retaining arm of a fluid injector.
10. 2. The syringe of claim 1, wherein at least one of the cylindrical load-bearing wall and the plurality of radial ribs enhances a refractive halo effect at a distal portion of the conical distal end wall due to electromagnetic radiation emitted from at least one electromagnetic radiation source within a piston or plunger head of a fluid injector.
11. 2. The syringe of claim 1, further comprising a neck connected to the fluid nozzle at a distal end of the conical distal end wall, the neck including a fluid passage having a plurality of longitudinal fluid diverting ribs extending at least partially radially inward from an inner surface of the neck into an interior of the fluid passage.
12. 12. The syringe of claim 11, wherein the plurality of longitudinal fluid redirecting ribs are configured to redirect fluid flowing through the neck passageway within the syringe such that the fluid flows along an inner surface of the conical distal end wall and an inner surface of the cylindrical side wall of the syringe.
13. The syringe of claim 12 , wherein at least some of the plurality of longitudinal fluid diverting ribs have different shapes.
14. The syringe of claim 12 , wherein at least some of the plurality of longitudinal fluid diverting ribs extend different distances from an inner surface of the neck into the fluid passageway.
15. 2. The syringe of claim 1, wherein the plurality of radial ribs extend along the conical distal end wall at an angle relative to a longitudinal axis of the syringe such that the distance between each adjacent pair of the plurality of radial ribs decreases from the cylindrical load-bearing wall toward the fluid nozzle.
Citation Information
Patent Citations
Syringe for use with medicine injector
JP2012045396A
Syringe and connector system
JP2018535023A
US10,420,902
US10,507,319
Front-loading medical injector and syringe for use therewith
US5383858A