Precision low-dose low-waste syringes and ergonomic attachments thereto

Abstract

To provide precision low-dose low-waste syringe configurations for facilitating precise control and delivery of syringe contents and for reducing or eliminating residual waste.SOLUTION: Syringe attachments 1800 and syringes 1900 have particular suitability to the precision dispensing of small amounts of high viscosity materials, such as dermal fillers. An attachment may include a main body having an assist feature that includes a wheel 1840 and pinion gears 1844 on both sides of the wheel which engage respective racks 1950 on the syringe body. A mechanical advantage may be provided to the user as the wheel is rotated relative to the syringe body and the racks. The syringes and attachments may include precision position indicators viewed from multiple positions to enable a user to determine the plunger position and the amount of dispensed contents with precision.SELECTED DRAWING: Figure 18

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application is a continuation-in-part of and claims the benefit of priority to U.S. Application No. 16 / 120,122, entitled "PRECISION LOW-DOSE, LOW-WASTE SYRINGES AND ERGONOMIC ATTACHMENTS THEREFOR," filed August 31, 2018, which claims the benefit of priority to Provisional Application No. 62 / 686,915, filed June 19, 2018, all of which are incorporated herein by reference.

[0002] The present disclosure generally relates to medical devices including syringes for controlling the delivery of drugs and biological fluids to a patient. The present disclosure also relates to syringe configurations that facilitate precise delivery of very small volumes and / or doses, as well as low waste of syringe contents. The present disclosure further relates to attachments and adapters for improving the ergonomics of syringe operation and allowing users precise control over syringe actuation. [Background technology]

[0003] In some medical fields, there is a trend to deliver smaller volumes and higher concentration doses of therapeutic compounds and drugs, typically by injection with a syringe.For example, in the field of cosmetic surgery, a recent trend includes a procedure called "high-dose microfocus" or "HDMF" injection of botulinum toxin, which may involve the use of highly precise amounts of compounds or mixtures in highly focused, localized areas of human face and body, with high concentrations and relatively small delivery volumes compared to the concentrations and volumes that have typically been used for such injections in the past in cosmetic treatments.The cost of these compounds and mixtures is relatively high to begin with.As the concentration increases, the relative cost of the amount of compounds and mixtures that are wasted also increases.

[0004] Some problems in the prior art stem from the limitations of existing syringes to be adapted for precision low dose / volume applications. For example, the ability to deliver precise volumes in increments as small as 0.01 ml may typically be required in such applications. Existing syringe configurations are not easily adapted to precisely control the delivery of such small increments. A related issue is the precise control and reading of the syringe as the form factor is reduced. Yet another issue is that prior art syringe configurations may reveal structural deficiencies as their form factors are reduced. More specifically, for example, significantly reducing the plunger diameter to fit into a reduced syringe lumen may make the plunger more susceptible to buckling or bending when force is applied, thus affecting the function and accuracy of the syringe. Also, as lumen diameter and other parameters are reduced, ergonomic factors including user comfort and control as well as readability of syringe indicia and plunger position become factors.

[0005] Yet another problem is the need to reduce the residual undelivered waste that remains in the "dead space" of prior art syringes, since as the concentration of an expensive substance, such as botulinum toxin, in the delivery vehicle (solvent) increases, the cost of the amount of wasted mixture also increases. Another problem relates to the structural shortcomings of conventional syringes as the size of the form factor is reduced.

[0006] Yet another problem is the need to precisely control the dispensing of syringe contents, such as dermal fillers and other compositions, which can be relatively viscous.

[0007] Therefore, it would be advantageous to provide a device including a syringe and attachment that addresses the above-mentioned shortcomings and other shortcomings in the prior art. Summary of the Invention

[0008] According to one aspect of the present disclosure, a precision low-volume, low-waste syringe configuration is provided to facilitate precise control and delivery of syringe contents and reduce or eliminate residual waste. The syringe configuration may have a reduced diameter lumen such that a relatively long travel of the syringe plunger is made to dispense a given volume of syringe contents, thereby improving the precision with which the contents can be dispensed. The total syringe volume may be about 0.25 or 0.50 milliliters.

[0009] According to another aspect of the present disclosure, an ergonomic attachment is provided for improving control and accuracy of delivery by a syringe. The attachment may be used with a syringe, such as the low-volume low-disposal syringe described herein, or may be used with known prior art syringes to improve its accuracy and control. The body extends axially to a plunger engagement end and a syringe guide end. The plunger engagement end may include a receptacle for receiving a thumb pad at the end of the syringe plunger. The guide end includes a guide that provides a sliding engagement with the syringe barrel. The body includes a gripping surface for allowing a user to engage the attachment with their finger or thumb and move the attachment body, and therefore the syringe plunger, relative to the syringe barrel using a sliding motion between the user's thumb and finger. This mode of operation improves control of the syringe, allowing the user to grip the syringe closer to the injection point (needle end), providing stability to the syringe plunger and providing more precise control of the delivery of the syringe contents.

[0010] According to a further aspect, the syringe attachment is provided with an assist feature, which may be a traction wheel attached to the attachment body. The traction wheel may provide mechanical advantage, i.e., leverage, so that the user can move the attachment body, and thus the syringe plunger, with great precision. Several wheel mounting slots may be provided in the attachment body so that the user can select a comfortable position. The attachment may be provided as a kit including several wheels of various sizes so that the user can configure the attachment according to comfort and control preferences. The wheels may be attached to selectively engage with the syringe barrel. In one configuration, the body may flex when pressure is applied by the user's thumb, allowing the wheels to engage the syringe barrel. In another configuration, the wheels may be biased to a disengaged position using a spring or elastic element in the mounting slot.

[0011] According to another aspect, the attachment is provided with features to generate a tactile indication of a precise incremental amount to the user. The syringe body may be provided with raised graduations formed thereon and on a surface that is engaged by the assist feature of the attachment. As the assist feature rolls over each raised portion, the user senses a tactile event and knows that the syringe plunger has moved by one increment. In this way, more precise indication and control of even smaller movements of the syringe plunger is facilitated.

[0012] According to another aspect, optical highlighting features are provided to improve the readability of the scale and plunger position. Small scale markings indicating increments as small as 0.01 ml may be provided on the syringe barrel. A magnifying element, such as a prism or lens, may be incorporated into the attachment near the syringe guide end. A reference sight, which may be a hairline indicator incorporated into the attachment and / or the magnifying element, may be provided on the attachment guide end to indicate the position of the attachment, and thus the plunger and plunger end, relative to the scale on the syringe barrel. In this way, very fine scale markings may be shown on the syringe barrel and can be read in conjunction with the plunger position to indicate very small incremental movements of the plunger.

[0013] According to a further aspect, a syringe is provided that is particularly suitable for low-dose applications. A small bore diameter and a small plunger diameter are required for a total syringe volume of 0.25ml or 0.50ml. The syringe barrel may be provided with graduations corresponding to 0.01ml increments, with 25 graduations for 0.25ml configurations and 50 graduations for 0.50ml syringes. The syringe may be provided with thick walls for ease of handling and control. Flat areas on the syringe barrel improve the readability of the graduations and visibility of the syringe contents and plunger piston, as well as operation with optical highlights on the attachment, which may include assist features to facilitate precise control of the plunger movement.

[0014] According to another aspect, the syringe plunger arrangement and needle hub / syringe face the dead space that is eliminated. The lumen end wall extends into abutting engagement with the end face of the needle hub. The plunger piston is provided with a flat surface so that when the plunger is in the fully inserted position, the lumen is completely empty and no waste material remains except within the small needle lumen. This reduces costs.

[0015] According to another aspect, a syringe attachment and syringe are provided that are particularly adapted for precision dispensing of small amounts of high viscosity materials such as dermal fillers. The syringe may include a generally circular barrel having a flat upper surface and a pair of lateral toothed elements such as axially extending racks. The attachment may include a body having a syringe plunger engagement end for engaging and holding the syringe plunger and a guide end opposite the plunger engagement end for receiving and slidably guiding the attachment body along the syringe body. The rolling element may include a wheel having an outer traction or gripping surface and an axle rotatably mounted on a pair of journals extending from the attachment body. The rolling element may include a pinion gear on either side of the wheel that engages a respective one of the racks. The pitch diameter of the pinion gear may be smaller than the diameter of the wheel outer gripping surface so that a mechanical advantage is provided to the user as the wheel and pinion rotates relative to the syringe body and rack, thus allowing the user to use the rolling elements to precisely move the carriage relative to the syringe body. Guide elements and guide edges on the attachment body provide smooth operation.

[0016] According to another aspect, the syringe attachment and syringe may include precision position indicators that are visible from multiple positions to allow a user to precisely determine the plunger position and the amount of contents dispensed. The indicators may be provided on both the flat top surface of the syringe body and on the sides of the syringe body. The attachment body may have a viewing window with a line of sight or reticle that allows a user to precisely determine the position of the attachment relative to the syringe. The syringe body may include a transparent or translucent material that allows the syringe plunger to be viewed from a top position through the syringe body and the viewing window. The attachment may also have a lateral position indicator that indicates the position of the attachment relative to the indicators on the sides of the syringe body, thus allowing a user to control the amount of contents dispensed by viewing from a lateral position.

[0017] According to another aspect, the attachment and attachment / syringe combination may utilize an attachment that may be slidably secured to the syringe such that, for example, a user may operate the syringe from a lateral position using a sliding motion of the thumb and fingers of one hand. This configuration may be particularly suitable for self-administration of insulin injections in the extremities (i.e., arms or legs) of the human body, where one-handed operation of a conventional syringe (thumb on plunger button) does not facilitate accurate dispensing of the syringe contents. [Brief description of the drawings]

[0018] The above and other attendant advantages and features of the present invention will become apparent from the following detailed description taken in conjunction with the accompanying drawings in which like reference numerals represent like elements throughout. It should be understood that the description and embodiments are intended as illustrative examples according to aspects of the present disclosure and are not intended to limit the scope of the invention as set forth in the claims appended hereto. [Figure 1] FIG. 1 is a perspective view of an exemplary attachment according to an aspect of the present disclosure assembled onto a syringe according to an aspect of the present disclosure. [Figure 2A] FIG. 2 is an exploded view of the attachment and syringe combination of FIG. 1. [Figure 2B] FIG. 2B is a detailed view of the portion of FIG. 2A shown. [Diagram 3] 2A-2C are perspective views of the attachment and syringe combination of FIG. 1 showing different positions of the attachment and syringe plunger. [Figure 4] 4 is a cross-section of the attachment and syringe combination of FIG. 3 taken along plane 4-4 of FIG. 3. [Diagram 5] 5 is a cross-section of the attachment and syringe combination of FIG. 3 taken along plane 5-5 of FIG. 3. [Figure 6] FIG. 4 is a top view of a portion of the attachment and syringe combination of FIG. 3 showing a magnified view through an optical element. [Figure 7]1 is a perspective view of a first alternative attachment configuration assembled on a syringe, where the attachment does not include an assist feature. [Figure 8A] 8A-8B are cross-sections showing an exemplary needle hub / syringe interface and plunger seal advantageous for a syringe having a total volume of about 0.25 ml, with the plunger in a slightly open position and a fully inserted position, respectively. [Figure 8B] Same as above. [Figure 9A] 9A-9B are cross-sections showing an exemplary needle hub / syringe interface and plunger seal advantageous for a syringe having a total volume of about 0.50 ml, with the plunger in a slightly open position and a fully inserted position, respectively. [Figure 9B] Same as above. [Figure 10] FIG. 13 is an exploded view of the attachment and syringe, where the attachment has an adjustable optics mounting component. [Figure 11] 13 is a perspective view of a second alternative attachment configuration assembled onto a syringe. [Figure 12] FIG. 12 is an exploded view of the alternative attachment and syringe combination of FIG. [Figure 13] FIG. 13 is a detailed perspective view of the syringe guide end of the alternative attachment of FIGS. 11 and 12. [Figure 14] FIG. 12 is a bottom perspective view of the attachment and syringe combination of FIG. 11. [Figure 15] FIG. 12 is a bottom perspective view of the attachment of FIG. 11. [Figure 16] FIG. 13 is a perspective view of a third alternative attachment and syringe combination. [Figure 17] FIG. 17 is a side view of the attachment and syringe combination of FIG. 16. [Figure 18] FIG. 13 is an exploded perspective view of a fourth alternative attachment and syringe combination. [Figure 19] FIG. 19 is a perspective view of the attachment and syringe combination of FIG. 18 assembled and shown in an extended position. [Figure 20] FIG. 19 is a perspective view showing the underside of the attachment of FIG. 18. [Figure 21] FIG. 19 is a top view of the attachment and syringe combination of FIG. 18. [Figure 22] This is a cross section taken along line 22-22 in FIG. [Diagram 23] This is a cross section taken along line 23-23 in FIG. [Figure 24] FIG. 13 is a perspective view of a combination attachment and syringe according to a fifth alternative embodiment. [Diagram 25] FIG. 25 is a perspective view of the attachment shown in FIG. 24. [Figure 26] FIG. 25 is a perspective view showing an installation step of the attachment shown in FIG. 24. [Figure 27] FIG. 1 is a perspective view of a syringe according to an aspect of the present disclosure. [Figure 28] FIG. 25 is a top view of the syringe / attachment combination of FIG. 24. [Figure 29] This is a cross section taken at 29-29 in Figure 28. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0019] The terms "cooperate," "cooperating," and "cooperating" as used herein are intended to imply an operational relationship between elements, for example, where movement of one element results in relative movement of the other element, directly or indirectly through one or more intermediate elements. Thus, a gear or pinion cooperating with a rack may include intermediate gears or other elements to cause or transmit relative motion between the gear and rack. The term "adapted to" as used herein means that an element or component includes a structure that can operate or be operated to achieve a particular result for which the element is adapted.

[0020] 1 and 2A show assembled and exploded views, respectively, of an exemplary syringe attachment 100 and syringe 200 according to an embodiment of the present disclosure. The attachment 100 may include an elongated body portion 110 extending from a syringe plunger engagement end 120 to an opposing syringe guide end 130. The body portion may include a gripping surface 112 that allows a user to apply a sliding force to the attachment using a finger and / or thumb. The syringe plunger engagement end 120 may include a receptacle or slot 122 for receiving a thumb pad or button 242 of the syringe plunger. An opening 124 may accommodate a plunger shaft 241. The receptacle 122 and / or opening 124 may be sized to provide a friction fit around the thumb pad 242 and plunger shaft 241 to hold the plunger securely against the attachment 100. 5 is a cross-sectional view further illustrating an exemplary orientation of the syringe button 242 within the syringe plunger engagement end 120 of the attachment. The syringe guide end 130 may include a generally U-shaped syringe guide 135 that is complementarily shaped to the exterior surface of the syringe barrel 210 and includes an interior surface 136 that facilitates sliding movement along the syringe barrel 210. The surface 136 may be provided with a friction reducing coating, lubricant, or surface texture. A pair of opposing retaining edges 138 may be formed within the guide end 130 to engage a flat portion of the syringe barrel to maintain the attachment aligned with the syringe barrel (and plunger) axis and prevent lateral and upward movement of the syringe barrel 210 within the guide 135.

[0021] According to an embodiment of the present disclosure, the syringe 200 has a profile, i.e., outer diameter, that facilitates handling, while including features to facilitate storage and delivery of very small incremental amounts, including a small bore, plunger diameter, and plunger seal. In this regard, the barrel wall may be of increased thickness compared to prior art syringe configurations. The syringe barrel 210 may be provided with an inner bore diameter that provides a total syringe volume of approximately 0.50 ml, with 50 graduations marked on the syringe barrel, or in another configuration, with 25 graduations marked on the syringe barrel, and provides a total syringe volume of approximately 0.25 ml. For example, in a 4 inch syringe length with a 0.50 ml volume and 50 graduations, each incremental amount of 0.01 ml may require a controlled plunger movement of approximately 0.08 inches. As will be appreciated by those skilled in the art, the features of the syringe and attachment described herein above and further below facilitate small, precisely controlled movements of the syringe plunger for such small incremental amounts.

[0022] 1 and 2A, the syringe 200 may include a plunger receiving end 230 having a flange 231 extending therefrom to allow for conventional operation of the syringe 200 using two fingers, one on either side of the flange 231, and a thumb on the thumb pad 242 of the syringe. The flange 231 may include a recess 232 to accommodate the width of the attachment 100. The wall thickness and material of the syringe are selected to provide a view of the syringe plunger piston 250.1 within the lumen when viewed through the flat portion 211 of the syringe barrel 200. The needle receiving end 220 of the syringe may engage a needle hub 260 in a manner described later herein.

[0023] According to another aspect of the disclosure, the attachment 100 may be provided with an assist feature 140 to enhance control of the movement of the attachment 100, and thus the movement of the syringe plunger 241 and piston 250.1 relative to the syringe barrel 200. The assist feature 140 may be provided in the form of a traction wheel that may include a rubberized outer member 142 attached to an inner hub 144. The hub 144 may include an extending shaft that is received in slots 114.1 and 114.2 of the attachment body 110. The assist feature 140 may provide a mechanical advantage or leverage to the user during operation. More specifically, the user may use their thumb and / or fingers to rotate the assist feature 140, which may selectively and frictionally engage the flat surface 211 of the syringe body 200. The diameter of the assist feature 140 provides the user with leverage, allowing the user to incrementally move the attachment using a rolling motion. With further reference to FIG. 4, the assist feature 140 may rest in the shown released position, where the assist feature 140 is slightly above and released from the flat surface 211 of the syringe. Selective engagement of the assist feature 140 may be provided by flexibility (deformation) of the body 110 of the attachment 100. Alternatively, a spring or biasing element may be incorporated into the axis of the hub 144 or into the slots 114.1 and 114.2, such that the assist feature 140 engages the surface 211 when a slight downward force is applied to the assist feature 140 by the user, and releases from the surface 211 when the user's force is removed. FIG. 3 illustrates the operation of an exemplary syringe / attachment combination, showing the syringe plunger in a position fully inserted into the syringe lumen.

[0024] According to further aspects of the disclosure, the attachment and / or syringe may be provided with features to facilitate tactile sensing of the incremental amount and movement of the syringe plunger. For example, referring to FIG. 2B, the scale indicia 212 on the flat surface 211 of the syringe barrel may be provided as raised elements, e.g., ridges or hashes, suitably dimensioned and formed within the syringe barrel to generate a tactile event, such as a slight resistance and / or clicking sound, that can be sensed by the user, as the assist feature 140 rolls over each ridge. Alternatively, the assist feature wheel hub 144 may be provided with a sound generator, such as a toothed and reed element, that generates a clicking sound for an incremental rotation corresponding to one scale mark on the syringe surface.

[0025] With further reference to FIG. 6, in accordance with another aspect of the present disclosure, the attachment 100 may be provided with an optical element 150 to improve the user's visibility of the syringe plunger piston 250.1 and the graduations 212, and thus increase the accuracy of the syringe operation. The syringe guide end 130 of the attachment may include a pair of upwardly extending side walls 132, each having a vertical shoulder 134 and a lower horizontal shoulder 136 that define a receiving space for the optical element 150. The optical element 150 may be a magnifying prism made of an optically transparent material and having magnifying properties. As will be appreciated, the optical element 150 moves with the syringe plunger and thus remains oriented above the syringe plunger piston 250.1 as the attachment and plunger move during syringe operation, thus allowing the user to see a magnified view of the plunger piston 250.1 and the graduations 212 as the syringe contents are dispensed / administered. The reference sight or reticle 180 may be a hairline element incorporated within or adjacent to the optical element or incorporated within an attachment, for example, and may provide an accurate indication of the movement of a syringe plunger piston even when the piston is not fully visible to the user due to the wall thickness or material of the syringe. As best seen in Figures 3 and 4, the flat bottom surface of the optical element 150 rests a small distance above the flat surface 211 of the syringe barrel. As will be appreciated, this distance allows for an accurate reading of the syringe graduations and plunger movement. Additionally, this distance may be adjusted / selected to vary the level of magnification provided by the optical element.

[0026] According to yet another aspect of the present disclosure, the assist feature and optical enhancement features of the attachments and attachment / syringe combinations contemplated herein include highly customizable aspects. The attachment 100 may include two or more mounting slots 114.1 and 114.2, allowing the user to customize the assist feature location, and therefore the attachment configuration, according to a desired comfort level. In addition, the assist feature 140 may be provided as a kit of several different sizes of wheels with attachments, allowing the user to select the desired wheel size to achieve precise control for the user's hand, finger, or thumb size, or other attributes. Similarly, the optical element 150 may be removable and secured on the attachment 100 with snap elements / detents, a kit of optical elements with various magnifications may be provided to allow customization according to the user's preferences, or the optical element may be removed to allow the user / physician to use an ocular loupe or magnifier in conjunction with the use of a syringe. As will be appreciated, the mounting configuration of the assist feature and optical enhancement features allows for rapid refitting of alternative parts.

[0027] 7 shows an alternative attachment configuration 700 in which the assist feature is omitted and the relative lateral (sliding motion) of the user's thumb and fingers is used to facilitate actuation of the syringe. The body 710 includes a gripping surface 712 to allow the user to engage their finger or thumb with the attachment and move the attachment body, and therefore the syringe plunger, relative to the syringe barrel, using a sliding motion between the user's thumb and fingers. This mode of actuation improves control of the syringe, allowing the user to grip the syringe closer to the injection point (needle end), providing stability to the syringe plunger and providing more precise control of the delivery of the syringe contents.

[0028] According to yet another aspect, the present disclosure provides a low waste syringe / needle interface and syringe plunger piston configuration. Figures 8A and 8B are cross-sections showing an exemplary needle hub / syringe interface and plunger seal advantageous for a syringe having a total volume of about 0.25 ml, with the plunger in a slightly open position and a fully inserted position, respectively. The needle hub 260 includes a needle 262 mounted therein and an end face 264 on which the end of the needle 262 is mounted flush. The needle hub 260 includes a male threaded base that engages with female threads on the syringe. The syringe 200 includes a lumen inner wall extension 242 having an end 243 that extends into the interior of the needle hub 260 and forms a sealing interface with the hub end face 264. The syringe plunger piston 250.2 includes an interior space for receiving the barbed end 245 of the plunger 240. The syringe plunger piston 250.2 also includes a flat end surface 252.2. As can be seen with further reference to FIG. 8B, when the piston is fully inserted into the syringe lumen, the piston end surface 252.2 abuts the end surface 264 of the needle hub, thus eliminating any dead space in the needle hub, thus completely emptying the lumen of the syringe contents. This can significantly reduce the cost of the expensive syringe contents. For delivery of the syringe contents, the needle 262 can be a 30 gauge needle, which is of small size and reduces pain and tissue damage during injection. Furthermore, one method of operating the devices contemplated herein is to utilize a larger (smaller gauge) needle of standard low-cost configuration on the syringe, such as a standard 20 gauge needle, to facilitate rapid withdrawal of the material (i.e., neurotoxin) into the syringe. Once the syringe is filled, a 30 gauge needle with low waste features described herein can be installed on the syringe and used for delivery.

[0029] 9A and 9B are cross-sections showing an exemplary needle hub / syringe interface and plunger seal advantageous for a syringe having a total volume of about 0.50 ml, with the plunger in a slightly open position and a fully inserted position, respectively. In this configuration, the syringe lumen has an enlarged diameter compared to the configuration of FIGS. 8A and 8B. The syringe piston 250.1 may include a first portion 253.1 having a diameter suitable for forming a seal with the lumen. The first portion 253.1 may taper to a smaller diameter portion 254.1 that fits within the lumen end wall, which may be of standard dimensions to fit a standard needle hub 260.

[0030] 10 is an exploded view of an alternative attachment configuration 1000 showing an alternative optical element mounting configuration. The attachment guide end 1030 can include a pair of circular mounting tubes 1032 (pair shown in FIG. 10) formed therein that receive respective mounting rods 1152 of a lens mounting frame 1154. A magnifying lens 1150 can be mounted within the lens mounting frame. This configuration can provide further magnification of the syringe scale and reference sight 1080 and can be adjusted to suit the user's preferences.

[0031] FIG. 11 is a perspective view of the assembled alternative attachment 1100 and syringe 200 according to the alternative attachment configuration 1100. FIG. 12 is an exploded view of the same embodiment. In this embodiment, the magnification element 1150 is oriented in a different direction than the embodiment of FIG. 1, with the flat side 1152 of the magnification element 1150 facing the assist feature 1140. This configuration provides additional clearance for the user's thumb when engaging the assist feature 1140 and provides a viewing angle of the magnified region of the syringe (the region below the magnification element 1150) that may be ergonomically advantageous, i.e., allowing the user to view the magnified region of the syringe from a direction closer to the focal region, toward the needle end of the syringe, as the user performs the injection.

[0032] FIG. 14 is a bottom perspective view of the attachment / syringe combination of FIG. 11 with the attachment shown in a "zero" position where the contents of the syringe are completely emptied. As can be seen, the reference sight or reticle 1180 is coincident with a scale 1402 that represents the "zero" or completely emptied position of the syringe. As will be appreciated, the "zero" scale may be offset from the zero position of the syringe plunger (i.e., when it bottoms out against the end wall of the lumen) so that the reticle 1180 and zero scale 1402 can accurately indicate to the user the completely emptied position of the attachment. With further reference to FIG. 15, the reticle 1180 may include a filament coated with a conspicuous color, such as red, to provide a sharp contrast when the user views the magnified syringe area within the field of view of the magnifying element 1150, allowing the user to see the exact location of the plunger (and the location of the attachment relative to the syringe). To further enhance visibility and accuracy, the attachment may include lateral reference shoulders 1182.1 and 1182.2 that coincide with the reference line or reticle 1180 to allow a user to view the position of the reticle 1180 from the side of the syringe. The reference shoulders 1182.1 and 1182.2 may include a coating of a conspicuous color, such as red, to further define the reference line on the attachment. As seen in FIG. 14, the reference shoulder 1182.2 aligns with the "zero" mark when the syringe plunger, and therefore the attachment, have reached their full travel distance relative to the syringe.

[0033] To further aid the user in viewing the location of the syringe plunger and plunger / contents interface, the bottom surface 214 of the syringe 200 may be provided with an opaque coating, which may be a color that provides a sharp contrast with the syringe contents and the syringe plunger. The opaque coating may substantially cover the bottom half of the barrel or may include a pattern that enhances the user's visibility of the syringe contents and plunger location. For example, an axially extending break may be provided in the opaque coating just below the lumen, and the translucency of the syringe barrel allows light to transmit from the underside of the syringe barrel to the inside of the lumen, thereby enhancing the user's visibility of the syringe contents and plunger location.

[0034] 16 and 17 show another alternative configuration of the syringe attachment and syringe. This configuration may be useful for precision dispensing of more viscous syringe contents, such as dermal fillers. In this configuration, the assist feature 1640 may include one or more toothed elements 1642.1 and 1642.2, such as pinion gears formed on the hub of a circular element, such as a wheel, that is rotatably mounted to the attachment body in a manner as described above with respect to elements 142 and 144 of FIGS. 1 and 2A. The pinion gears 1642.1 and 1642.2 cooperate with respective geared rack elements 1280.1 and 1280.2 formed on the flat portion 1211 of the syringe barrel 1210. This configuration provides positive actuation (i.e., no slippage) function of the syringe attachment relative to the syringe, as will be appreciated. The rubber gripping surface 1644 may enhance the user's ability to rotate the assist feature 1640. Additionally, the assist feature 1640 may be mounted such that it can rotate freely (i.e., the pinion is not engaged with the rack) without any lateral pressure (downward in FIG. 16) on the assist feature. This may be accomplished by a spring element supporting the wheel 1644 within the mounting slot 1614 (FIG. 17) on the attachment, or by making the body of the attachment sufficiently flexible such that lateral pressure on the assist feature 1640 causes deformation of the attachment body, resulting in the pinion gear engaging with the rack. In this way, inadvertent actuation of the plunger can be avoided; that is, the user must apply lateral pressure to the assist feature before rotating it to dispense the syringe contents. The pitch and profile of the pinion and rack teeth may be designed such that each incremental engagement of the teeth corresponds to each graduation on the syringe or a predetermined volume of material to be dispensed. Additionally, the profile of the pinion and rack teeth may provide interference or may include protrusions or other features that provide tactile and audible feedback to the user, i.e., a clicking sensation or sound that corresponds to known incremental dispense volumes or graduations on a syringe.

[0035] 18-23 show a syringe and attachment combination that may be particularly suitable for precise, low waste dispensing of relatively small amounts of high viscosity materials, such as dermal fillers. This combination provides not only positive control of the syringe attachment, and therefore plunger position, relative to the syringe body, but also a mechanical advantage that reduces the force a user must apply to dispense highly viscous contents. The attachment 1800 may include a body 1810 having a top wall 1811 and two side walls 1814, a plunger engagement end 1820, and a guide end 1835 for receiving the syringe 1900 and facilitating guided movement therealong. The body 1810 may include a viewing window 1850 (see FIGS. 18, 20, and 21) defined therein for viewing the syringe top surface, indicators thereon, and the syringe plunger end (viewed through the transparent or translucent syringe body). The guide ends 1835 may include opposing guide extensions 1837 that may resiliently deform outwardly to allow installation of the attachment 1800 onto the syringe 1900. The guide extensions 1837 may include guide surfaces 1839 that may engage the lower curved syringe barrel 1910 to facilitate sliding movement of the attachment relative thereto. The guide extensions 1837 include lateral position indicators 1838 that match with lateral indicators 1913 on the sides of the syringe body to pinpoint the position of the attachment, and therefore the syringe plunger, when the system is viewed laterally from either side (see also FIG. 20 ).

[0036] 20 and 23, a pair of guide rails 1832 may be formed on the inside of the sidewall 1814 to engage the top surface 1912 (FIGS. 18 and 19) of the syringe 1900 and allow sliding movement of the attachment relative thereto. The guide rails 1832 combine with guide surfaces 1839 on the guide extensions 1837 to provide a snug fit of the attachment 1800 onto the syringe 1900 while allowing sliding movement. To this end, the guide rails and guide surfaces 1839 may be provided with a friction reducing coating, treatment, or fused material to further enhance manipulation and sliding movement and prevent binding of the attachment to the syringe 1900.

[0037] 20, the attachment plunger engagement end 1820 may include a plunger button retention feature 1821 that may include a first protrusion 1822 that forms a groove 1823 for receiving the top end of the plunger button 1942 (FIG. 20). A second protrusion 1824 may provide a snap-fit ​​retention of the plunger button 1942 on the attachment plunger engagement end 1820.

[0038] According to an embodiment of the present disclosure, the attachment 1800 may include an assist feature that may comprise a rolling element or wheel 1840 that may include an outer traction or gripping surface 1841, a central axle 1842, and one or more pinion gears 1844 (shown in FIG. 18 with the understanding that another gear is hidden from view on the opposite side of the wheel 1840). The wheels 1840 may be mounted for rotation within a pair of opposing journals 1816 extending upwardly from the attachment body 1810. The journals 1816 may include tapered receiving slots extending into circular recesses that may define snap joints on each side of the axle 1842 for ease of assembly and reliable operation. As will be appreciated, the pinion gears 1844 may engage and be integrally formed with respective toothed racks 1950 extending upwardly from the syringe body 1900.

[0039] As will be appreciated, the relationship between the wheel diameter DW (FIG. 23) and the pitch diameter PW of the pinion gear provides a mechanical advantage to the user such that the force applied to the outer traction surface of the wheel (i.e., by the user's thumb during operation) multiplies the force applied to the rack by the pinion gear, and thus a multiplied force is applied to the syringe plunger, facilitating the dispensing of more viscous materials with reduced user effort. Additionally, the wheel and pinion configuration reduces the distance traveled by the attachment relative to the syringe for a given degree of rotation of the wheel, thereby providing the user with more precise control of the plunger movement and dispensing of the syringe contents.

[0040] According to aspects of the present disclosure, attachment kits may be provided with wheels of different sizes and different pinion pitch diameters, allowing for on-site customization by the user for a given syringe content. Additionally, the present disclosure contemplates different modes of cooperation of the pinion gears and rack, including the use of intermediate gear elements (i.e., one or more intermediate gears between the pinion and rack) to achieve desired operating characteristics, mechanical advantages, and attachment motion characteristics.

[0041] Similar to the above example, a haptic event feature may be incorporated into the assist feature to provide a tactile sensation to the user for each incremental movement of the attachment relative to the syringe body. This may be accomplished, for example, by providing a protrusion on the wheel journal that partially engages one or more teeth of the pinion to produce a clicking sound and tactile sensation each time a pinion tooth passes, so the user knows exactly when an incremental rotation of the wheel occurs.

[0042] The features described in the above examples for improving visibility of the syringe plunger, such as providing a highly visible color on the seal at the plunger end and providing an opaque bottom surface on the syringe through which the plunger can be seen, can also be applied to the examples of Figures 18-23.

[0043] 24-29 show an attachment and attachment / syringe combination according to another embodiment of the present disclosure. This configuration provides an attachment that can be slidably secured to a syringe, for example, so that a user can operate the syringe from a lateral position using a sliding motion of the thumb and fingers of one hand. This configuration may be particularly suitable for self-administration of insulin injections in the extremities (i.e., arms or legs) of the human body, where one-handed operation of a conventional syringe (thumb on plunger button) does not facilitate accurate dispensing of the syringe contents.

[0044] The exemplary attachment 2400 may include an elongated body 2410 having a syringe plunger engagement end 2410 and a guide end 2435. The syringe plunger engagement end 2410 may include a first fixed wall 2422 extending generally perpendicularly from the body 2410 and including a recess formed therein for receiving and retaining the shaft of a syringe plunger 2542 in a snap-fit ​​manner (FIG. 26). A second wall 2424 may extend from the body 2410 for abutting the plunger button 2541 and may form a plunger button receiving recess or groove 2425 therein for receiving and retaining the plunger button. A viewing window 2450 (FIGS. 24, 26 and 28) may be formed in the attachment body to provide for viewing of the top planar surface of the syringe, indicia thereon, and, if the syringe is made of a transparent or translucent material, of the syringe plunger moving within the syringe lumen. Additionally, a lateral position indicator 2438 (FIGS. 24-26) may match lateral markings on the side of the syringe body to provide a precise indication of attachment position, plunger position and therefore dosage in use.

[0045] The guide end 2435 may include a continuous guide ring 2436 that extends across two lateral guide extensions 2437 extending from the attachment body 2410. The lateral guide extensions 2437 and the guide ring 2436 may include guide surfaces on their inner walls to engage the syringe body and facilitate sliding movement of the attachment relative thereto. The attachment 2400 may include a thumb-engaging protrusion 2440 having a generally semicircular shape and including a gripping or non-slip surface 2441. Located on the underside of the attachment body 2410 and near or coincident with the thumb-engaging protrusions may be a pair of guiding protrusions 2445 (FIGS. 25 and 29) that may have circular surfaces for engaging a flat surface 2512 of the syringe 2500. The attachment 2500 may also include a pair of guide rails 2432 for engaging the syringe top flat surface 2512. The guiding projections 2445, guide rails 2432, and guiding surfaces of the guiding extensions 2437 and guiding rings 2435 provide a stable and smooth movement of the attachment relative to the syringe.

[0046] Figure 26 shows an installation step for installing the attachment 2400 onto a syringe 2500 whereby the needle end of the syringe is first inserted through the attachment guide end 2435. The attachment plunger engagement end is then rotated downward (clockwise in Figure 26) until the plunger shaft snaps into the first wall, thus retaining the syringe plunger therein.

[0047] FIG. 27 shows further details of an exemplary syringe suitable for use with the attachments described herein. The rear flange 2531 of the syringe may include a recess 2532 to accommodate the attachment body 2410 and allow sliding movement of the attachment 2400 relative to the syringe 2500. The top flat surface 2512 provides a stable guiding surface for engaging the attachment's guide protrusion 2445 (FIG. 25) and guide rail 2432 (FIG. 25) while facilitating reading of the indicia thereon. It should further be appreciated that the physical dimensions of the syringe 2500 are particularly advantageous for self-administration of insulin and other materials in low-dose applications. More specifically, the syringe comprises a relatively small lumen and a relatively large syringe body outer dimension (round portion width and diameter) such that the width and length of the syringe reduce the possibility of mishandling and injury. Additionally, the smaller bore diameter results in a longer plunger travel distance for a small volume, thus providing greater visibility of smaller graduations and more precise control of the dosage by the user based on the sliding movement of the attachment.

[0048] According to one embodiment of the disclosure, the attachment described above with respect to Figs. 24-29 may include a tactile event feature to indicate incremental movement to the user in a tactile and / or audible manner. For example, the indicia 2515 on the flat surface 2512 may include major graduations (i.e., every 0.1 cc) that extend laterally across the flat surface and are uneven compared to the flat surface. The guide projections 2445 (Fig. 25) may be positioned to encounter the uneven graduations as the attachment slides against the syringe body and generate a tactile sensation and / or clicking noise that is sensed by the user. This enhances the precise control available to the user. As a further alternative, a rolling ball or element may be provided on the underside of the attachment to roll over the uneven graduations as the attachment moves against the syringe body.

[0049] While the practice of the invention has been described with reference to certain exemplary embodiments, it will be apparent that various changes and modifications can be made to these embodiments without departing from the broader spirit and scope of the invention as set forth in the appended claims. The specification and drawings are therefore to be regarded in an illustrative rather than a restrictive sense.

Claims

1. An attachment for a syringe, the syringe comprising a syringe body and a plunger, the attachment comprising: a body having a plunger engagement end adapted to engage the plunger; An attachment comprising: an assist feature cooperatively associated with the body and having a rolling element adapted to rotate relative to the attachment body and cooperate with the syringe body, wherein rotation of the rolling element causes movement of the attachment and the plunger relative to the syringe body.

2. 2. The attachment of claim 1, wherein the assist feature rolling element comprises at least one attachment toothed component adapted to engage with at least one syringe body toothed component on the syringe body.

3. 3. The attachment of claim 2, wherein the at least one attachment toothed component is a pinion gear on the rolling element.

4. The attachment of claim 2 , wherein the toothed component of the at least one syringe body comprises at least one rack of teeth extending axially along the syringe body.

5. The attachment of claim 1 , wherein the rolling elements provide a mechanical advantage for moving the attachment body relative to the syringe body.

6. 4. The attachment of claim 3, wherein the rolling elements have outer contact surfaces, the outer contact surfaces being a radial distance from an axis of rotation of the rolling elements greater than the pitch radius of the pinion gear.

7. The attachment of claim 4 , wherein the at least one toothed rack is integrally formed with the syringe body.

8. The attachment of claim 1 , wherein the attachment body further comprises a guide end for receiving the syringe body to movably support the attachment relative to the syringe body.

9. The attachment of claim 8 , wherein the guide end includes a pair of laterally extending guide extensions for engaging the syringe body.

10. 2. The attachment of claim 1, wherein the attachment body includes a viewing window formed therein to allow a user to view the syringe body when the attachment is placed thereon.

11. 1. A system for manipulating a syringe, comprising: a syringe comprising a syringe body and a plunger; A system comprising an attachment comprising: a body having a plunger engagement end adapted to engage with the plunger; and an assist feature cooperatively associated with the body and having a rolling element adapted to rotate relative to the attachment body and cooperate with the syringe body, wherein rotation of the rolling element causes movement of the attachment and the plunger relative to the syringe body.

12. The system of claim 11 , wherein the assist feature rolling element comprises at least one attachment toothed component adapted to engage with at least one syringe body toothed component on the syringe body.

13. The system of claim 12 , wherein the toothed component of the at least one attachment is a pinion gear on the rolling element.

14. The system of claim 2 , wherein the toothed component of the at least one syringe body comprises at least one rack of teeth extending axially along the syringe body.

15. The system of claim 1 , wherein the syringe body has a flat surface and the attachment includes at least one guide rail for guiding the attachment along the flat surface.

16. The system of claim 1 , wherein the attachment body includes a viewing window formed therein to allow a user to view the flat surface of the syringe body.

17. 1. A system for manipulating a syringe, comprising: a syringe comprising a syringe body and a plunger, the syringe body having an axially extending flat surface; An attachment, a plunger engagement end adapted to engage the plunger; and a guide end adapted to receive and support the attachment for sliding movement on the syringe body. a thumb engagement projection for enabling a user to apply a force to the attachment to cause axial movement relative to the syringe body; a viewing window formed in the body to allow a user to view a flat surface of the syringe; and a pair of guide rails on the body for supporting the attachment for sliding movement over a flat surface of the syringe.

18. 18. The attachment of claim 17, further comprising at least one guide protrusion disposed proximate the thumb engagement protrusion for supporting the attachment for sliding movement over a flat surface of the syringe body.

19. 20. The system of claim 17, further comprising a tactile indicator for generating a tactile event to the user as the body moves relative to the syringe body.

20. 18. The attachment of claim 17, wherein the guide end of the attachment body includes a U-shaped extension for receiving the syringe body.

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