Transitioning member for syringe suspension delivery system

Abstract

The present disclosure provides a syringe comprising a body defining a reservoir for containing a medicament, the body having a body diameter, a transitioning member in communication with the reservoir, the transitioning member having a series of gradually decreasing diameters over a transitioning length of between 3 mm and 100 mm, and a needle having a needle fluid path in communication with the transitioning member and configured to deliver the medicament to a patient's body at a needle tip.

Description

TRANSITIONING MEMBER FOR SYRINGE SUSPENSION DELIVERY SYSTEMCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 716,388, filed November 5, 2024, the entire contents of which are incorporated by reference herein.FIELD OF THE DISCLOSURE

[0002] The present disclosure relates generally to syringes and injectors. More specifically, the present disclosure relates to devices and methods for preventing clogging of needle-based syringes and injectors.BACKGROUND OF THE DISCLOSURE

[0003] Certain high concentration drug products utilize staked-in-needle or luer-lock prefilled syringe delivery devices, which may be prone to needle clogging. Certain products, like suspensions, are prone to needle clogging due to, for example, particle agglomeration within parts of the syringe. Additionally, once drug product has entered the needle fluid path there is potential for water vapor transmission to occur through the prefilled syringe rigid needle shield, which leads to drying of the drug product within the needle fluid path and causes the drug product to crystalize. As the drug product crystalizes, it forms solid-like particles which can result in needle clogging or partial occlusions.

[0004] When the needle clogging phenomenon occurs, it prevents the end user (e.g., healthcare professional, patient, etc.) from being able to administer the therapeutic dose. Inability to administer therapeutic dosage or a missed dose can have a multitude of negative implications including customer or patient annoyance, impact to therapeutic treatment plans, and increased cost of treatment. Depending on the specific drug product being administered the variety and extent of these implications may differ. Because of this, particle jamming and needle clogging represent a major challenge in the delivery' of suspension formulations.

[0005] Thus, there exists a need for devices that improve upon and advance the methods of safely using injectors and syringes, such as prefilled syringes, and to reduce the possibility of clogging during use.SUMMARY OF THE DISCLOSURE

[0006] In some examples, a syringe comprises a body defining a reservoir for containing a medicament, the body having a body diameter, a transitioning member in communication with the reser oir, the transitioning member having a series of gradually decreasing diameters over a transitioning length of between 3 and 100 mm, and a needle having a needle fluid path in communication with the transitioning member and configured to deliver the medicament to a patient’s body at a needle tip.

[0007] In some examples, a syringe comprises a body defining a reservoir for containing a medicament, the body having a body diameter, a transitioning member in communication with the reservoir, the transitioning member having a series of linearly decreasing diameters over a transitioning length, the transitioning member having a slope expressed as a difference in diameter from the first end to the second end over the transition length of between 0.1 and 2, and a needle having a needle fluid path in communication with the transitioning member and configured to deliver the medicament to a patient’s body at a needle tip.

[0008] In some examples, a method of delivering a medicament comprises: providing a syringe comprising (a) a body defining a reservoir and having a body diameter, (b) a transitioning member in communication with the reservoir, the transitioning member having a series of linearly decreasing diameters over a transitioning length, the transitioning member having a slope expressed as a difference in diameter from the first end to the second end over the transition length of between 3 and 100 mm, and (c) a needle having a needle fluid path in communication with the transitioning member and configured to deliver the medicament to a patient's body at a needle tip; filling the reservoir with the medicament, the medicament having particles with a particle density of 1.4 g / cm3, a particle size having a mean diameter of 10 pm, and a particle concentration of 5 vol%; and delivering the medicament from the reservoir through the transitioning member and the needle fluid path.BRIEF DESCRIPTION OF THE DRAWINGS

[0009] Various embodiments of the presently disclosed syringes are disclosed herein with reference to the drawings, wherein:

[0010] FIG. 1 is a schematic front view of a prefilled syringe.

[0011] FIG. 2 is a schematic side view of one example of a syringe having a transitioning member.

[0012] FIGS. 3A-3B are schematic representations of a conventional staked-in needle and a staked-in needle having a transitioning member.

[0013] FIGS. 4A-4B are schematic representations of a conventional luer-lock needle and a luer-lock needle having a transitioning member.

[0014] FIGS. 5A-5C are illustrations showing the inner sidewall geometries of three configurations of a glass syringe with a staked-in needle, a plastic syringe with a luer-lock hub / needle attachment, and a syringe with the proposed transitioning member, respectively.

[0015] FIG. 6 are photographs of fluorescent imaging used to observe a staked-in syringe throughout injection.

[0016] FIGS. 7A-7C illustrate experimental conditions, plunger force plots and experimental summaries for glass syringes with staked-in needles.

[0017] FIGS. 8A-8C illustrate experimental conditions, plunger force plots and experimental summaries for syringes having a luer-lock plastic hub.

[0018] FIGS. 9A-9D illustrate fluorescent imaging, plunger force plots and experimental summaries for glass syringes having staked-in needles and an improved transitioning member.

[0019] FIGS. 10A-10E illustrate fluorescent imaging, plunger force plots and experimental summaries for glass syringes having luer-lock needles and an improved transitioning member.

[0020] FIGS. 11 A-l IB illustrate comparisons of a prior art stopper and a conical stopper according to one aspect of the disclosure.

[0021] Various embodiments are described below with reference to the appended drawings. It is to be appreciated that these drawings depict only some embodiments of the disclosure and are therefore not to be considered limiting of its scope.DETAILED DESCRIPTION OF THE DISCLOSURE

[0022] Despite the various improvements that have been made to injectors and syringes, such as prefdled syringes, conventional methods suffer from some shortcomings as discussed above. Therefore, there is a need for further improvements to the devices and methods used to deliver medication and prevent clogging. Among other advantages, the present disclosure may address one or more of these needs.

[0023] As used herein, the term ‘'proximal,” when used in connection with a component of a syringe or injector, refers to the end of the component closest to the user’s hands when holding the device; whereas the term “distal,” when used in connection with a component of a syringe or injector, refers to the end of the component closest to the needle insertion site during use.

[0024] Likewise, the terms “trailing” and “leading” are to be taken as relative to the operator’s fingers (e.g., physician) of the syringe or injector. “Trailing” is to be understood as relatively26029 close to the operator’s fingers, and “leading” is to be understood as relatively farther away from the operator’s fingers.

[0025] Reference is now made to FIG. 1, which shows an exemplary syringe 100 (in this specific embodiment, which is prefilled) contained within a needle safety device. It will be understood that though a needle within a safety device is shown, the disclosure is not thus limited. For example, though a prefilled syringe with a staked needle is shown, it will be understood that the principles disclosed herein are equally applicable to other types of injectors (e.g., syringes with removable needles, auto-injectors, or on-body (wearable) injectors having needles, etc.). Syringe 100 generally comprises two main portions, a plunger rod assembly 110 and a barrel 120. Plunger rod assembly 110 generally extends between a proximal end 112 and a distal end 114, and generally comprises an elongated piston 115 and a housing 116 extending between a plunger flange 117 and a stopper 130.

[0026] A cylindrical barrel 120 extends between proximal end 122 and distal end 124 and comprises a body 125 defining a lumen 126 for accepting a portion of plunger rod assembly 110. Body 125 further comprises a barrel flange 127 adjacent proximal end 122 and defines a reservoir “R” that holds a medicament, drug, saline, or other substance for injecting into a patient's body. An internally threaded stopper 130 is disposed inside lumen 126 of body 125. In one embodiment, stopper 130 is made of an elastomeric material such as natural rubber, synthetic rubber, thermoplastic elastomers, or combinations thereof, and comprises an opening to receive and mate with a portion of plunger rod assembly 110 by advancing a portion of the plunger rod assembly inside the barrel lumen 126 and rotating at least one of coupler 119 and stopper 130 relative to the other. At distal end 124, a needle 134 is coupled to a hub 133 (in this specific embodiment, which is a plastic hub), which in turn is coupled to body 125 of barrel 120. In this example, a cap 135 is disposed over needle 134. Once cap 135 is removed, the user may pierce the patient’s skin with the needle, then push on plunger flange 117 to drive the plunger to deliver a medicament through needle 134 into the patient’s body.

[0027] Clogging may occur at various portions along the length of the syringe including clogging sites Cl and C2 as shown in Fig. 1. For example, clogging may occur at or near hub 133 (e.g., at the proximal end of needle 134) adjacent clogging site Cl when particles accumulate locally within the hub. Needle clogging results in stopping the flow through the needle, increasing hydrodynamic pressure in the syringe that is often associated with leakage at the luer- lock connection or rubber stopper interface with the syringe wall, which are signatures of injection failure and poses a major risk of compromising dose accuracy and patient safety. Particle jamming and needle clogging are key challenges in delivery7of suspension (i.e.,26029 multiphase) formulations. It is a phenomenon by which the particles (i. e.. solid phase) locally accumulate to occlude the flow, leading to injection or delivery failure.

[0028] FIG. 2 illustrates a syringe 200 having a body 205, a transitioning member 207 and a needle 209. In this example, body 205 is generally cylindrical and defines a body length BL1 and a body diameter BD1. Body 205 may define a reservoir "R” for storing a substance. In some examples, body length BL1 may be between 50 and 200 mm and body width BD1 may be between 3 and 60 mm. Body 205 may be disposed adjacent transitioning member 207, which may have a conical shape that tapers from a first larger side (i.e., adjacent the body 205) to a second smaller side (i.e.. adjacent needle 209). In the examples shown, transitioning member 207 may gradually decrease in diameter from body diameter BD1 down to 0. 1 mm to 0.3 mm (e.g., 0.22 mm), which is the inner diameter of needle 209. In some examples, this steady decrease in the diameter of transitioning member 207 may happen over a transitioning length TL1 of between 3 mm and 100 mm, or between 5 mm and 80 mm, or between 10 mm and 50 mm. or between 20 mm and 40 mm. In some examples, transitioning member 207 may have a series of gradually decreasing diameters along transitioning length TL1. This gradual decrease in diameter may be linear (as shown in Fig. 2) or non-linear (e.g., parabolic, exponential, etc.). In some examples, the extent of decrease or contraction of transitioning member 207 may be defined as a rate of change in diameter over a rate of change in transitioning member length, or as a slope of between 0.1 and 2 (e.g., 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0 or 1.5).

[0029] In some examples, transitioning member 207 and body 205 are unitarily formed as show n, and both may be formed of the same material (e.g., glass, plastic, etc.). Conversely, transitioning member 207 may be formed separate from body 205, and may be included as part of a coupleable hub that mates with the body via a coupling mechanism. Thus, the general concept of using such a transitioning member 207 may be used in two types of suspension delivery systems: glass syringes with staked-in needles, and plastic syringes with luer-lock needles. In either case, the transitioning member may enable enhanced injection of suspensions by reducing the risk of particle jamming and needle clogging. Without being bound by any particular theory, initial experiments demonstrate that the injection behavior as monitored by plunger injection force profiles were superior to conventional devices. Moreover, by tracking the particle flow and its interaction with the needle and syringe during the injection, it was demonstrated that the improved transitioning member yields a better flow profile. Thus, these transitioning members provide anew suspension delivery system with the advantage of enabling clog-free delivery of suspension formulations that would otherwise exhibit unacceptable cloggingwhen delivered through conventional syringe systems. This may be particularly useful for delivery of high-concentration and / or high-viscosity suspension formulations.

[0030] FIGS. 3A-3B and 4A-4B are schematic cross-sectional views useful for illustrating the differences in the flow channels defined between the body and the needle in several syringes. FIGS. 3A-3B illustrate the differences between a conventional syringe with a staked-in needle (FIG. 3A) and an improved syringe system having an extended contraction length within a transitioning member (FIG. 3B). In both figures, the needle is permanently affixed to the syringe by embedding (or “staking”) the base of the needle into the syringe hub. In these examples, the needle may be affixed to a metal or plastic hub using heat staking, ultrasonic staking or an adhesive. This creates a secure and stable connection that prevents the needle from becoming detached or loose during use. Staked-in needles are commonly used in disposable syringes to ensure safety, precision, and reliability. As shown in FIGS. 3A-3B, conventional syringe 300A includes a body 305a, a short hub 307a and a needle 309a. While hub 307a may appear relatively long, the inner diameter contracts suddenly from the body diameter to the needle diameter within less than the first 50% of the hub as shown by the dashed outline in FIG. 3A. Conversely, syringe 300B includes a body 305b, an extended transitioning member 307b and a needle 309b. Body 305a and body 305b may be the same size and / or shape, and needle 309a and needle 309b may be the same shape and / or size. In this example, transitioning member 307b is longer than hub 307a with a transitioning length of TL2 that is more than double the length of the contracting section of short hub 307a. It will be understood that the lengths, diameters and / or ratios (e.g., slopes) for determining the overall shape of transitioning member 307b may be set according to those described above with reference to FIG. 2.

[0031] FIGS. 4A-4B illustrate the differences between a conventional syringe with a luer-lock connection (FIG. 4A) and an improved syringe system having an extended contraction length within a transitioning member (FIG. 4B). Luer-lock needle styles are designed to provide a secure and leak-free connection between the needle and syringe and include a locking mechanism where the needle hub has a threaded or twist-on design that fits onto the corresponding threads of a luer-lock syringe body. This ensures a firm and reliable connection, minimizing the risk of accidental disconnection or leakage during procedures. Luer-lock needles are typically made from stainless steel mounted to a hub 407a having a thread that mates with a thread on a barrel of a syringe body. As shown in FIG. 4A, conventional syringe 400A includes a body 405a, a short and separable hub 407a and a needle 409a mounted on hub 407a with luer- lock connection 408a. While hub 407a is relatively long, the inner diameter contracts suddenly from the body diameter to the needle diameter within less than the first 60% of the hub as show nby the dashed outline. Conversely, syringe 400B of FIG. 4B includes a body 405b, an extended transitioning member 407b formed as part of a decouplable hub, and a needle 409b. In this example, transitioning member 407b may be integrally formed with, or defined by, a hub having a luer-lock connection 408b with body 405b. Body 405a and body 405b may be the same size and / or shape, and needle 409a and needle 409b may be the same shape and / or size. In this example, transitioning member 407b is longer than hub 407a with a length of TL3 that is more than double the length of short hub 407a. The lengths, diameters and / or ratios determining the overall shape of transitioning member 407b may be set according to those described above with reference to FIG. 2.

[0032] To further illustrate the differences between these syringes, FIGS. 5A-5C shows the inner sidewall geometries of three configurations including a glass syringe with a staked-in needle (FIG. 5A), a plastic syringe with a luer-lock hub / needle attachment (FIG. 5B) and a tapered configuration with the proposed transitioning member (FIG. 5C). For direct comparison, all three configurations have a similar needle inner diameter of about 0.22 mm. A close examination of the cross-sectional views of the devices, reveals that a glass syringe with a staked-in needle (FIG. 5A) includes a sudden and short contraction length, and this sudden contraction that abruptly transitions from the barrel inner diameter to the needle inner diameter increases the risk of particle accumulation. Likewise, a conventional plastic syringe with luer- lock hub / needle attachment (FIG. 5B) provides an extended contraction length, but subjects the flow to unnecessary contractions, expansions, and dead zones in the cavities in the region close to the needle-plastic interface. These dead zones generate vortices and flow disturbances, serving as nucleation sites for particle jamming. Conversely, the proposed syringe with an extended and tapered transitioning member includes a relatively long contraction length with a gradual, smooth taper, eliminating geometrical imperfections (FIG. 5C).EXPERIMENTS:

[0033] A series of experiments were conducted to quantify the injection performance of a reference suspension formulation for various configurations. For these comparative evaluations, silver-coated hollow glass spherical particles having a mean diameter of 10 pm and a densify of 1.4 g / cm3 (Dantec Dynamics A / S, cat. no. S-HGS-10, SKU: 80A7001, Denmark) were used. The particles were suspended in water and the formulation properties were maintained consistently among all the experiments. The only exception was that particle concentration was varied in terms of particle volume percent (vol%). Vertical injection experiments into air were conducted while monitoring the plunger force using a force sensor to detect potential clogging. Fluorescent26029 imaging was used to observe the syringes throughout injection. Fig. 6 presents exemplary snapshots of two cases. The top two images show a first case where clogging occurred (10 vol% particle concentration). Here, a steady outflow is evident at the start of injection before the onset of clogging, which is accompanied by stopped flow and visible particle build-up in the contraction region. The bottom two images show a second case where no clogging occurred (1 vol% particle concentration). Here, there was no evidence of flow disruption through to the end of injection.

[0034] FIGS. 7A-C present the results of a series of experiments with glass syringes with staked-in needles. Three distinct performance behavior zones / regions were discovered as a function of particle concentration according to experimental conditions outlined in FIG. 7A. FIG. 7B shows several plunger force plots for various particle concentrations as the variable. At 5 vol% particle concentration, clogging was observed in 5 out of 5 trials, therefore 5 vol% marked the upper limit of particle concentration. At the lower particle concentration of 2.5 vol%. we observed clogging in 5 out of 10 trials, indicating the existence of a transition zone. When particle concentration was further reduced to 1 vol%, no clogging was observed in 5 trials. Hereafter, we use the transition zone particle concentration as a metric to compare clogging performance between various syringe / needle systems. In summary, the transition zone (i.e., the zone where some, but not all clogging occurred) for glass syringes with a staked-in needle is in the range of 2.5 vol%, illustrated in FIG. 7C.

[0035] Next, a similar set of experiments was conducted to observe the effect of the extended contraction length geometry of a luer-lock hub on clogging behavior (i.e., the transition zone particle concentration) in a manner consistent with the methods of the first set of experiments shown in FIGS. 7A-7C. FIG. 8A shows that the experimental conditions and the overall results that show that the use of a plastic syringe / hub resulted in a higher transition zone (i.e., a transition zone occurred at a higher particle concentration), considering the needle inner diameter was consistent between glass and plastic delivery systems. FIG. 8B shows plunger force-time plots for various particle concentrations as the variable. The longer contraction length according to the present disclosure resulted in a transition zone at 10 vol% particle concentration (clogging occurred in 6 out of 10 trials, FIG. 8B), versus the 2.5 vol% transition zone of the glass syringe of FIG. 7C. Thus, it was observed that the plastic syringe / hub was less likely to clog and that transition zone clogging occurred at a 4-fold higher particle concentration than a similar staked- in needle. It is believed that the experiments demonstrate that hub geometry may shift the transition zone and enable successful clog-free injection of suspension formulations that would otherwise not be deliverable due to clogging under identical conditions.

[0036] Next, experiments were carried out to compare the performance of a syringe having a transitioning member according to FIG. 2 with a staked-in syringe. To eliminate differences due to manufacturing techniques, a 3D-printed mock-up of a stock SCHOTT® syringe with a stakedin needle was compared to a 3D-printed glass prototype of a staked-in needle according to the current disclosure. Fluorescent imaging snapshots during injection experiments are shown in FIG. 9A where the top is the stock SCHOTT® staked-in needle, the middle image shows the 3D- printed mocked-up of the staked-in syringe, and the bottom shows a 3D-printed syringe with the improved transitioning member. For these glass designs, the 3D-printed control geometry' mimicking the stock SCHOTT® syringe with staked-in needle, performed similarly to the stock needle, with a matching transition zone behavior concentration at 2.5 vol% and clogging zone concentration of 5 vol%, as evident in the plunger force plots of FIGS. 9B-9C.

[0037] Specifically , FIGS. 9B-9C show plunger force plots showing a reduction in clogging behavior under identical particle concentrations. Specifically, using the 3D-printed proposed configurations with the extended transitioning member under these identical conditions, the previous transition zone case at 2.5 vol% was transformed to a no-clogging zone (clogged in 0 / 5 injections), and the clogging zone case at 5 vol % was altered to transition zone behavior (FIG. 9B-9C), highlighting a key improvement in both cases where an identical suspension was not otherwise deliverable, limited by injectability issues. Fig. 9D are phase diagrams highlighting the ability of the proposed configuration with the extended transitioning member to reduce clogging risk, and visually shows the measurable transition zone alteration toward improved suspension syringeability'.

[0038] Next, experiments were carried out to compare the performance of a syringe having a transitioning member according to FIG. 2 with a luer-lock syringe. To eliminate differences due to manufacturing techniques, a 3D-printed mock-up of a plastic syringe with a luer-lock needle was compared to a 3D-printed prototy pe of a luer-lock needle having a transitioning member according to the instant disclosure. Fluorescent imaging snapshots during injection experiments are shown in FIG. 10A where the top is a stock BD LUER-LOK ® needle, the middle image shows the 3D-printed mock-up of the LUER-LOK ® needle, and the bottom shows a 3D-printed syringe with the improved transitioning member. In this example, the 3D-printed control geometry exhibited higher clogging risk as compared to a stock BD syringe with BD LUER- LOK ® needle. In other words, a particle concentration of 10 vol% corresponded to clogging zone behavior (e.g., clogging in 5 / 5 trials) (FIG. 10B). We attribute this difference to manufacturing sample-to-sample geometrical variations. Using the 3D-printed tapered configuration with the proposed transitioning member under these identical conditions, theclogging zone case at 10 vol% was transformed to a no-clogging zone (clogged in 0 / 5 injections, Fig. 10C) and an extreme clogging zone case at 20 vol% was altered to transition zone behavior (Fig. 10D), highlighting a profound reduction in clogging risk in cases where the suspension had previously clogged in every attempt. FIG. 10E visually shows the measurable transition zone alteration toward improved suspension syringeability for the proposed luer-lock configurations.

[0039] FIGS. 1 1A-1 IB illustrate comparisons of a conventional stopper and a conical stopper according to one aspect of the disclosure. As shown in FIG. 11 A, a syringe 1100 according to the present disclosure may have a generally cylindrical body 1105, a conical transitioning member 1107 and a needle 1109. Conventional stoppers, such as stopper 1150 are generally cylindrical and when used with syringe 1100, they will not be able to reach the distal end of the transitioning member 1107 due to the series of decreasing inner diameters of the transitioning member. This will result in dead space between the stopper and the distal end of the transitioning member. Conversely, Fig. 1 IB shows the same syringe 1100 but with a modified stopper 1160 that has a complementary shape to the transitioning member 1107. Specifically, modified stopper 1160 may include a short cylindrical base 1162 and a conical nose 1164. Conical nose 1164 may have a size, shape and / or slope that corresponds to the inner geometry of transitioning member 1107 so that the distal end of the conical nose 1164 can reach the distal end of the transitioning member, eliminating dead space within the transitioning member when it is longitudinally or axially advanced between position Pl within body 1105 to position P2 within the transitioning member.

[0040] It is to be understood that the embodiments described herein are merely illustrative of the principles and applications of the present disclosure. For example, the shape and type of transducer(s) used may be varied as well as the type of coupler. Moreover, certain steps are optional, and the disclosure contemplates various configurations and combinations of the steps disclosed herein. It is therefore to be understood that numerous modifications may be made to the illustrative embodiments and that other arrangements may be devised without departing from the spirit and scope of the present disclosure as defined by the appended claims.

[0041] In some examples, a syringe may include a body defining a reservoir for containing a medicament, the body having a body diameter, a transitioning member in communication with the reservoir, the transitioning member having a series of gradually decreasing diameters over a transitioning length of between 3 and 100 mm, and a needle having a needle fluid path in communication with the transitioning member and configured to deliver the medicament to a patient’s body at a needle tip.26029

[0042] In some examples, any of the features recited in the disclosure may be combinable with others. For example, the syringe may have a transitioning length between 3 and 20 mm; and / or the series of gradually decreasing diameters may show a linear decrease from a first end to a second end; and / or the linear decrease has a slope expressed as a difference in diameter from the first end to the second end over the transition length of between 0. 1 and 2; and / or the series of gradually decreasing diameters shows a non-linear decrease from a first end to a second end; and / or the series of gradually decreasing diameters decrease from a first inner diameter of between 3 and 60 mm to a second inner diameter of between 0. 1 and 0.3 mm; and / or the body and the transitioning member are unitarily formed; and / or the body and the transitioning member are separately formed; and / or the transitioning member and the needle are secured to one another; and / or the transitioning member is formed as part of a hub with a luer-lock coupler; and / or the needle is a staked-in needle permanently affixed to the end of the transitioning member; and / or the transitioning member comprises glass or plastic; and / or the syringe further includes a stopper having a conical shape that complements a shape of the transitioning member.

[0043] In some examples, a syringe includes a body defining a reservoir for containing a medicament, the body having a body diameter, a transitioning member in communication with the reservoir, the transitioning member having a series of linearly decreasing diameters over a transitioning length, the transitioning member having a slope expressed as a difference in diameter from the first end to the second end over the transition length of between 3 and 100 mm, and a needle having a needle fluid path in communication with the transitioning member and configured to deliver the medicament to a patient’s body at a needle tip.

[0044] In some examples, any of the features recited in the claims are combinable with others. For examples, the series of linearly decreasing diameters may decrease from a first inner diameter of between 3 and 60 mm to a second inner diameter of between 0.1 and 0.3 mm; and / or the body and the transitioning member are unitarily formed; and / or the body and the transitioning member are separately formed; and / or the transitioning member and the needle are secured to one another; and / or the transitioning member is formed as part of a hub with a luer-lock coupler; and / or the needle is a staked-in needle permanently affixed to the end of the transitioning member.

[0045] In some examples, a method of delivering a medicament comprises; providing a syringe comprising (a) a body defining a reservoir and having a body diameter, (b) a transitioning member in communication with the reservoir, the transitioning member having a series of linearly decreasing diameters over a transitioning length, the transitioning member having a slope expressed as a difference in diameter from the first end to the second end over the transition26029 length of between 3 and 100 mm, and (c) a needle having a needle fluid path in communication with the transitioning member and configured to deliver the medicament to a patient’s body at a needle tip; filling the reservoir with the medicament, the medicament having particles with a particle density of 1.4 g / cm3, a particle size having a mean diameter of 10 pm, and a particle concentration of 5 vol%; and delivering the medicament from the reservoir through the transitioning member and the needle fluid path.

[0046] In some examples, any of the features recited in the claims or disclosed herein are combinable with others. For example, the needle may be a staked-in needle permanently affixed to the end of the transitioning member.

[0047] It will be appreciated that the various dependent claims and the features set forth therein can be combined in different ways than presented in the initial claims. It will also be appreciated that the features described in connection with individual embodiments may be shared with others of the described embodiments.

Claims

CLAIMS1. A syringe comprising: a body defining a reservoir for containing a medicament, the body having a body diameter; a transitioning member in communication with the reservoir, the transitioning member having a series of gradually decreasing diameters over a transitioning length of between 3 mm and 100 mm; and a needle having a needle fluid path in communication with the transitioning member and configured to deliver the medicament to a patient’s body at a needle tip.

2. The syringe of claim 1, wherein the transitioning length is between 3 mm and 20 mm.

3. The syringe of any one of claims 1-2, wherein the series of gradually decreasing diameters shows a linear decrease from a first end to a second end.

4. The syringe of claim 3, wherein the linear decrease has a slope expressed as a difference in diameter from the first end to the second end over the transition length of between 0. 1 and 2.

5. The syringe of any one of claims 1-4, wherein the series of gradually decreasing diameters shows a non-linear decrease from a first end to a second end.

6. The syringe of any one of claims 1-5, wherein the series of gradually decreasing diameters decrease from a first inner diameter of between 3 and 60 mm to a second inner diameter of between 0.1 and 0.3 mm.

7. The syringe of any one of claims 1-6, wherein the body and the transitioning member are unitarily formed.

8. The syringe of any one of claims 1-6. wherein the body and the transitioning member are separately formed.

9. The syringe of any one of claims 1-6, wherein the transitioning member and the needle are secured to one another.

10. The syringe of any one of claims 1-6, wherein the transitioning member is formed as part of a hub with a luer-lock coupler.

11. The syringe of any one of claims 1-6, wherein the needle is a staked-in needle permanently affixed to the end of the transitioning member.

12. The syringe of any one of claims 1-11, wherein the transitioning member comprises glass or plastic.

13. The syringe of any one of claims 1-12, further comprising a stopper having a conical shape that complements a shape of the transitioning member.

14. A syringe comprising: a body defining a reservoir for containing a medicament, the body having a body diameter; a transitioning member in communication with the reservoir, the transitioning member having a series of linearly decreasing diameters over a transitioning length, the transitioning member having a slope expressed as a difference in diameter from the first end to the second end over the transition length of between 3 and 100 mm; and a needle having a needle fluid path in communication with the transitioning member and configured to deliver the medicament to a patient’s body at a needle tip.

15. The syringe of claim 14, wherein the series of linearly decreasing diameters decrease from a first inner diameter of between 3 and 60 mm to a second inner diameter of between 0.1 and 0.3 mm.

16. The syringe of any one of claims 14-15, wherein the transitioning member and the needle are secured to one another.

17. The syringe of any one of claims 14-16, wherein the transitioning member is formed as part of a hub with a luer-lock coupler.

18. The syringe of any one of claims 14-17, wherein the needle is a staked-in needle permanently affixed to the end of the transitioning member.

19. A method of delivering a medicament, comprising: providing a syringe comprising (a) a body defining a reservoir and having a body diameter, (b) a transitioning member in communication with the reservoir, the transitioning member having a series of linearly decreasing diameters over a transitioning length, the transitioning member having a slope expressed as a difference in diameter from the first end to the second end over the transition length of between 3 and 100 mm, and (c) a needle having a needle fluid path in communication with the transitioning member and configured to deliver the medicament to a patient’s body at a needle tip; filling the reservoir with the medicament, the medicament having particles with a particle density of 1.4 g / cm3, a particle size having a mean diameter of 10 pm, and a particle concentration of 5 vol%; and delivering the medicament from the reservoir through the transitioning member and the needle fluid path20. The method of claim 19, wherein the needle is a staked-in needle permanently affixed to the end of the transitioning member.

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