Quick release plunger

A syringe system and components thereof are disclosed. The system may include a syringe body having a hollow lumen, a proximal open end, and a distal end. The syringe body may be configured to house a fluid therein. The syringe system may further include a plunger positioned in the hollow lumen of the syringe body, forming a seal with an inner wall of the syringe body. The plunger may include a removable piston having a shaft extending from the distal end towards the proximal open end, a stopper removably connected to a distal portion of the shaft, and at least one coupler attached to the distal portion of the shaft. The stopper may be configured to slidably move within the hollow lumen to facilitate movement of the fluid within the syringe body. The coupler may be configured to facilitate removal and attachment of the stopper from the piston.

BACKGROUND

A number of injector-actuated syringes and powered injectors have been developed for use in medical procedures, such as, for example, angiography, computed tomography, and nuclear magnetic resonance. Numerous advances have been made in the area of injector-actuated syringes and power injectors for use therewith. Nonetheless, newly developed and developing medical procedures constantly test the limits of current injector systems. For example, some procedures require the use of high pressures but also require physiochemical properties of the syringe that make attainment of high pressures difficult. Changes in syringes to meet the requirements of the newly developed and developing medical procedures may result in necessary changes to other portions of the injector to properly operate with the syringe, which puts care providers at the disadvantage of having to obtain new and costly injectors each time a new syringe is developed.

SUMMARY

In an embodiment, a syringe system may include a syringe body having a hollow lumen, a proximal open end, and a distal end. The syringe body may be configured to house a fluid therein. The syringe system may further include a plunger positioned in the hollow lumen of the syringe body, forming a seal with an inner wall of the syringe body. The plunger may include a removable piston having a shaft extending from the distal end towards the proximal open end, a stopper removably connected to a distal portion of the shaft, and at least one coupler attached to the distal portion of the shaft. The stopper may be configured to slidably move within the hollow lumen to facilitate movement of the fluid within the syringe body. The coupler may be configured to facilitate removal and attachment of the stopper from the piston.

In an embodiment, a plunger apparatus that can be at least partially removed from a syringe may include a removable piston having a shaft extending from a distal end of the syringe towards a proximal open end of the syringe, a stopper removably connected to a distal portion of the shaft, and at least one coupler attached to the distal portion of the shaft. The stopper may be configured to slidably move within a hollow lumen of the syringe to facilitate movement of fluid within the syringe. The coupler may be configured to facilitate removal and attachment of the stopper from the piston.

In an embodiment, hydraulically-activated plunger in a fluid delivery system may include a first syringe comprising a first diameter, a proximal end, a distal end having an aperture, and a hollow lumen configured to house a fluid therein, and a stopper configured to slidably move within the hollow lumen to facilitate movement of the fluid within the hollow lumen, an internal piston having a distal end and a proximal end. The distal end may be removably attached to the stopper and configured to move the stopper within the hollow lumen of the first syringe, and the proximal end may be fluidly attached to a second syringe having a proximally positioned tip and a second diameter that is smaller than the first diameter. The plunger may further include a third syringe having a distally positioned tip and a third diameter that is smaller than the first diameter, wherein the distally positioned tip of the third syringe is in fluid communication with the proximally positioned tip of the second syringe and an external piston fluidly connected to the third syringe. The external piston may include a plunger and the second syringe and the third syringe may each contain an incompressible fluid sealed therein.

DETAILED DESCRIPTION

For purposes of the description hereinafter, the terms “upper,” “lower,” “right,” “left,” “vertical,” “horizontal,” “top,” “bottom,” “lateral,” “longitudinal,” and derivatives thereof shall relate to the orientation of embodiments disclosed in the figures. However, embodiments may assume alternative variations and step sequences, except where expressly specified to the contrary. The specific devices and processes illustrated in the attached drawings and described in the following specification, are exemplary embodiments. Hence, physical characteristics related to the embodiments disclosed herein are not to be considered as limiting.

The word “proximal” refers to a direction relatively closer to a clinician or operator using the device described herein, and the word “distal” refers to a direction relatively further from the clinician or operator. For example, the end of a syringe placed nearest the body of a patient is considered a distal end of the syringe, while the end closes to the clinician is a proximal end of the syringe. The terms “axial” or “axially” refer generally to an axis around which the particular objects being referred to are preferably formed (although not necessarily symmetrically therearound). The term “radial” refers generally to a direction normal to the axis or along a radius of an object having a circular cross-section.

Various embodiments are directed to plungers for syringes, including stoppers that may be connected and disconnected from the piston. In various embodiments, such plungers may be manually, hydraulically, or electrically activated. In the embodiments disclosed herein, the same injector can be used for a variety of different syringes because of the ease of attaching and removing the piston portion of the syringe to the stopper portion through the use of a coupler. Furthermore, the present disclosure provides a quick and easy solution for care providers because the piston can be inserted and connected to the stopper without a specific orientation. For example, a user may advance the piston forward until it engages with the connector by snapping into place, regardless of orientation, as will be described in greater detail herein. In addition, a simple ¼ turn twist at any orientation may allow for detachment of the two elements.

FIG. 1depicts a syringe, generally designated10, that may include a cylindrical syringe body1defining a hollow lumen4therein, an open proximal end3, and a conical shaped distal end2having an aperture5. A plunger, generally designated12, may be positioned in the hollow lumen4of the syringe body1extending from the conical shaped distal end2and towards the open proximal end3. The plunger12may include a piston100having a shaft115extending from a proximal thumb rest110to a distal stopper20. In various embodiments, an attachment may be attached to the distal end2of the syringe10to facilitate delivery and/or movement of the fluid of the syringe body1to or from, for example, a blood vessel and/or the like of a human or an animal patient. Specific examples of attachments may include, for example, needles, catheters, tubes, and/or the like.

The stopper20may generally have a circumference that is substantially equal to an inner circumference of the syringe body1and may be received by the open proximal end3of the syringe body. The stopper20may slidably move within the lumen4to facilitate movement of fluid within the syringe body1. The type of fluid is not limited by this disclosure and may include any fluids including, for example, a pharmaceutical drug, a radiopharmaceutical, a contrast agent, a radioactive contrast agent, gene therapy fluid, and/or the like. In some embodiments, the stopper20may facilitate movement of the fluid towards and through the distal end2of the syringe10. In other embodiments, the stopper20may facilitate movement of the fluid towards the proximal end3of the syringe10. In particular embodiments, as shown inFIG. 2, the stopper20may have a cylindrical body22and a protrusion tip21sized and configured to substantially fill at least a portion of the conical shaped distal end2of the syringe body1(FIG. 1).

Referring back toFIG. 1, the piston100may provide a generally reciprocal movement of the stopper20through the syringe body1. In some embodiments, movement of the stopper20and/or the piston100may allow for the fluid to be drawn into the lumen4of the syringe body1by placing the distal end2of the syringe body and/or an attachment thereto into the fluid and withdrawing the plunger12. In some embodiments, movement of the stopper20and/or the piston100may allow for the fluid to be expelled from the lumen4of the syringe body1by advancing the piston into the syringe body. In some embodiments, the stopper20may be fixedly attached to a proximal end105of the piston100. In other embodiments, the stopper20may be detachably connected to the proximal end105of the piston100, allowing the piston to be removed and used with one or more different components discussed herein, such as stoppers and the like. For example, in the case of pre-filled syringes, various components may be reused to reduce the amount of disposable materials.

As depicted inFIG. 3, the plunger12configured according to some embodiments may include, for example, a piston100having a proximal end107and a distal end105. The proximal end107may include at least a thumb rest110that may be configured to be used by an operator to move the plunger12axially forward or backward within the syringe body1(FIG. 1). In some embodiments, a coupler150may be attached to the distal end105of a piston100. Referring also toFIG. 4A, in some embodiments, a proximal end135of the coupler150may be detachably connected to a shaft115of the piston100using a fastening mechanism such as, for example, screws, snaps, rivets, and/or the like, as will be described in greater detail herein. In other embodiments, the coupler150may be fixedly attached to the shaft115using, for example, an adhesive. In still other embodiments, the coupler150may be a contiguous part of the piston100by, for example, injection molding the piston to include the coupler.

In various embodiments, the coupler150may include a substantially circumferential groove140(or140′ inFIG. 4C) at a distal end130of the piston100. In some embodiments, the groove140(or140′) may be continuous for the entire length of the coupler150. In other embodiments, the circumferential groove140(or140′) may contain one or more gaps therein. In some embodiments, the groove140(or140′) may have at one or more extensions (element147inFIG. 4Bor147′ inFIG. 4C)) extending radially from the groove. In particular embodiments, the groove140may include about 1 to about 8 extensions. In other particular embodiments, the groove140may include 2 extensions, 3 extensions, 4 extensions, 5 extensions, 6 extensions, or 8 extensions. The extensions147(or147′) may extend outwardly from the groove140(or140′) at least to an outer circumference of the piston100. In some embodiments, the extensions147(or147′) may extend beyond the outer circumference of the piston100. The extensions147(or147′) may have a substantially triangular shape, such as, for example, a substantially equilateral triangle, a substantially isosceles triangle, a right triangle, and the like. In some embodiments, the extensions147may include at least one or more notches155on one or more sides of the extensions on an outermost portion of each extension. The notches155may have any cross-sectional shape such as, for example, a square (as shown inFIG. 4B), a rectangle, a triangle, a circle, an ellipse, and/or the like. In various embodiments, the notches155may or may not be symmetrical. In some embodiments, the extensions147and the notches155may intersect in a flat170(FIG. 4A) such that the flat is substantially tangential to the outer surface of the extension.

In some embodiments, as illustrated inFIG. 4D, the notches155′ may extend from the surface of the extension147′. The notches155′ may have, for example, a triangular cross-section having straight and/or curved sides, or any other shape (not shown). In some embodiments, the notches155′ may or may not be symmetrical. In various embodiments, an outermost edge of the notches155′ may extend beyond the outermost circumference of a tapered flange145′. In some embodiments, the notches155′ may be angled to extend from the proximal end of the extensions147′ distally towards the tapered flange145′ forming a helical ridge. In some embodiments, the notches155′ may be tapered distally along the circumferential surface of the extensions147′. Various embodiments may have one or more notches155′, such as, for example, two notches.

In some embodiments, the coupler150may include the tapered flange (145inFIG. 3or145′ inFIG. 4C) extending distally from the groove140(or140′). In some embodiments, a maximum radius of the tapered flange145(or145′) may be equal to or shorter than the radius of the piston100. In some embodiments, one or more deflectors157(FIG. 4A) may be disposed as one or more protuberances on the outer surface of the tapered flange145and may be axially distal to the notches155. The shape of the deflectors is not limited by this disclosure, and may include any shape. Specific examples of deflector shapes may include conical shapes, hemispherical shapes, triangular shapes, and/or the like.

In various embodiments, the proximal end of the piston100may be detachably connected to one or more actuating mechanisms (not shown) such as, for example, a hydraulic assembly and/or an electric motor to aid the motion of the piston.

Referring to FIGS.5and6A-6C, the distal portion of the piston100and/or the coupler150may be configured to engage the stopper20(FIG. 1) as described herein. In some embodiments, the stopper20(FIG. 1) may include at least a base200including one or more capture members220protruding rearwardly beyond the rear surface255of the base by an amount sufficient to capture and retain the tapered flange145of the coupler150. The capture members220may be constructed of a flexible material such that the capture members flex outwardly when contacted by the tapered flange145and subsequently snap back to an original position after passing the tapered flange to engage the circumferential groove140. While embodiments having two capture members220are shown and described here, embodiments having more than two capture members are also envisioned, depending on, among other things, the shape of the coupler and/or the number of extensions147. The capture members220may include inwardly facing shoulders215that may be sized and designed to engage the circumferential groove140extending from each capture member on a proximal end of the capture member. In certain embodiments, the capture members220may further include extensions225extending proximally beyond the inwardly facing shoulders215. In various embodiments, the base200may or may not be detachable from the stopper20(FIG. 1). In embodiments where the base200is detachable from the stopper20, the base may have one or more helical threads260at its distal end270that may be configured to be screwed into an opening in the proximal end25of the stopper (FIG. 1).

As shown inFIG. 6A, in operation, the piston100may be positioned to contact the base200and engage the tapered flange145. As the piston100is pushed against the base200, the inwardly facing shoulders215may be forced outwardly until the tapered flange145passes beyond the shoulders of the capture members220, as described in greater detail herein. This design may allow the piston100to stably engage with the stopper20(FIG. 1) at any axial position of the plunger12along the syringe axis without substantially dislocating the stopper from its position along the syringe axis. In some embodiments, the shoulders215may be aligned to engage the circumferential groove140when the stopper20(FIG. 1) is properly mounted in the syringe body1. In some embodiments where the circumferential groove140contains one or more gaps as described herein, the gaps may allow the shoulders215to release up with a deflector to prevent the shoulders from being loaded in the gap. In embodiments having deflectors disposed on the tapered flange145as previously described herein, the deflectors may deflect the capture members220to prevent the capture members from lining up with the notches155.

After retention of the coupler150(FIG. 3) by the capture members220, the stopper20may resist disconnection from the piston100upon rearward movement of the piston. In some embodiments, the capture members220may be designed such that forces exerted on the capture members upon rearward movement of the piston100substantially prevent radially outward movement of the capture members. In some embodiments, shoulders215of the capture members220may be positioned such that the load experienced upon rearward movement of the piston100is at a position equal to or greater in radial distance relative to axis B than one or more anchors250where the capture members are attached to the base200. Thus, a bending movement created by a rearward movement of the piston100may cause the capture members220to deflect radially inward and assist in preventing disconnection of the stopper20(FIG. 1) from the piston100.

When the piston100is twisted about its axis B, the extensions147(or147′) may push the capture members220radially outward as the radial distance of the groove140surface increases allowing the piston to be disengaged from the stopper20upon rearward movement of the piston while it is twisted. In embodiments having notches155extending from the extensions147, the notches may act as position indicators and/or twist-stops to stop the piston100from further twisting. In some embodiments, the flats170may provide positions at which the piston100may be disengaged from the stopper20(FIG. 1). This design may allow for detachment of the piston100from the stopper20with a twist of the piston that depends on the number of extensions147or the number of capture members220. In particular embodiments, the twist of the piston100may be less than 180°, less than 120°, less than 90°, less than 72°, less than 60°, or less than 45°.

In embodiments such as those depicted in inFIGS. 4D and 6C, the piston100may be twisted about its axis B in such a manner that the notches155′ extending from the extensions147′ may push the beveled edges210(FIG. 5) of the capture members220. In some embodiments, the beveled edges210(FIG. 5) may be pushed axially forward in a direction forward of the outer circumference of the tapered flange145′. In some embodiments, the beveled edges210(FIG. 5) may be pushed such that the inwardly facing shoulders215of the base200are disengaged from the tapered flange145′. This movement may disconnect the stopper20(FIG. 1) from the piston100when the stopper20is connected to the base200. Additionally, in embodiments in which the notches155′ are formed as distally angled helical ridges on the extension147′ surface, twisting the piston100may result in pushing the beveled edges210radially outward by the extension surface and axially forward by the notches. As such, the inwardly facing shoulders215of the capture members220may clear the tapered flange145′ while the piston100is being twisted. In embodiments where a user attempts to attach the piston100in an orientation where the notches155extending from the extension147′ line up with the beveled edges210, the one or more deflectors157(FIG. 4A) may push the beveled edges to either side of the deflector so that the beveled edges do not get stuck in the notches.

In various embodiments, as depicted inFIGS. 7A and 7B, one or more cantilevered capture members320may be disposed at the distal end of the piston300anchored from the distal wall310of the piston and disposed around a central extension340of the piston. In such embodiments, the capture members may have outwardly extending shoulders325and beveled surfaces327at the distal end of the capture members320. In some embodiments, the piston300may have at least two capture members320. In some embodiments, the piston300may have 2, 3, 4, 5, 6, or 8 capture members320. In some embodiments, the piston300may have capture members320that may be symmetrically disposed around the central extension340.

In various embodiments, the stopper350may have one or more retainer arms360. In other embodiments, a base (not shown) having retainer arms360may be fabricated to fit into a stopper20for retrofitting one or more commercially available stoppers. As the piston300is moved forward through an opening355provided by the retainer arms360of in the stopper350, the beveled edges327may tend to push the capture members320radially inward. Upon passing the retainer arms360of the stopper350, the capture members320may snap back to engage the shoulders325, thereby preventing the piston300from detaching from the stopper upon rearward movement of the piston. In various embodiments, the capture members320may be placed around the piston head340such that a rearward movement of the piston300pushes the capture members radially outward.

As depicted inFIG. 8, some embodiments may include a piston500having a coupler that is an angled flange510contiguously connected to the piston500via a hinge525such that a distal surface535of the angled flange may form an angle θ, with the axis D of piston500. In particular embodiments, the angle θ may be acute. In some embodiments, the hinge525may have an open position wherein the radially outermost portion of the distal surface535of the angled flange510extends no further than the outer wall530of the piston500. In some embodiments, the hinge525of the angled flange510may have a closed position wherein the angled flange510tilts about the hinge at an increased angle θ.

In some embodiments, the plunger12may be operated by moving the piston100forward and twisting it. The angled flange510may engage with one or more threads555disposed on an inner wall of the stopper550. Upon further forward movement, the angled flange510may tilt about the hinge525, thereby placing the hinge in the closed position, and further engaging with the threads555. This may prevent the piston500from detaching from the stopper550when moved in a rearward direction. Likewise, twisting in an opposite direction may disengage the angled flange510from the threads555, thereby placing the hinge in the open position and allowing the piston500to be detached from the stopper550. Such a design may allow for an easy engagement and/or detachment of the piston500from the stopper550in, for example, pre-filled syringes. Such a design may also allow for an easy engagement and/or detachment of any axial position of the stopper550without substantially dislocating the stopper from its axial position.

As depicted inFIG. 9, some embodiments of the piston400may include a plurality of axially-stacked detachable couplers410,410A,410B. In various embodiments, the plurality of couplers410,410A,410B may be stacked on a spring loaded platform420in an axially disposed cavity430within the piston400. Retainer arms425at the opening of the cavity430may prevent the end coupler410from receding back into the cavity430. When using the piston400, the end coupler410may be removed or detached from the piston after using the piston with a first syringe. Another coupler410A (or410B) may replace the removed end coupler410and become the new end coupler for using the piston400with a second (or a subsequent) syringe. In various embodiments, the end coupler410may be removed by any means of removal now known or later developed, such as, for example, twisting the piston400, detaching the piston using the various quick-release mechanisms described herein, or breaking the end coupler off. In some embodiments, any number of couplers410may be loaded inside the cavity430for use, where the number of piston heads is only limited by the size of the cavity and/or the storage capability of the cavity. A specific number of piston heads may be, for example about 1 piston head to about 10 piston heads. In some embodiments, the detachable coupler410may reduce cross-contamination, such as, for instance, when a single piston400is used with multiple syringes, where one of the detachable couplers may be removed and disposed of after each use.

In some embodiments, the piston may be part of a hydraulically activated or an electrically activated assembly. In some embodiments, for example, as depicted inFIG. 10, an internal piston620may have a hydraulic assist so as to reduce the force required by an operator using the syringe assembly600to deliver the contents of the syringe. A first syringe605portion of the syringe assembly600may have a diameter D3. The internal piston620may be connected to both the first syringe605and a second syringe625having a diameter D2. The diameter D2of the second syringe625may generally be smaller than the diameter D3of the first syringe605. In some embodiments, the internal piston620may be connected to the first syringe605in such a manner that a proximal end615of the internal piston engages a first stopper610located in the first syringe. In some embodiments, the internal piston620may be connected to the second syringe625in such a manner that a distal end617of the piston engages a second stopper630located in the second syringe. A first tip631of the second syringe625may be connected to a second tip632of a third syringe635. The third syringe635may have a diameter D1that may be generally smaller than the diameter D2of the second syringe625.

In some embodiments, a lumen of the second syringe625and a lumen of the third syringe635may each be filled with an incompressible fluid675. In particular embodiments, the incompressible fluid675may be sealed within the respective lumens of the second syringe625and the third syringe635. An external piston650connected to the third syringe635may engage a plunger640. When the external piston650is moved forward, the fluid675pushes the internal piston620which further pushes the first stopper610. In some embodiments, because the fluid675is incompressible, the force placed upon the internal piston620is amplified by a factor of (D2)2/(D1)2as the external piston650is moved forward. The diameters of various syringes605,625,635may be optimized by a skilled artisan depending on particular requirements for particular embodiments and/or usage thereof.

In any of the various embodiments disclosed herein, it may be desirable to determine the total volume delivered using a plurality of syringes. Pistons of some embodiments may have a sliding scale or a marker system for indicating and/or measuring the volume of fluid disposed out of or collected into the syringe before the piston is detached. For example, as illustrated inFIG. 11, a piston725may have at least a measuring scale730configured to indicate a volume displaced by the plunger710after the piston725is engaged with the plunger and moved forward through the syringe700. In some embodiments, the scale730may be detachably affixed to an O-ring750such that the O-ring detaches from the scale when piston725engages with the plunger710and attaches to the piston marking an initial volume. As the piston725is moved forward through the syringe700, the scale730may slide along the O-ring750, thus indicating the volume being delivered or removed. A user of the syringe700may determine the volume of a particular fluid delivered or removed by observing the scale730marked on the syringe. The O-ring750may indicate a total volume delivered at the end of delivery by the syringe700, including the volume delivered from other syringes.

Although various embodiments have been described in detail for the purpose of illustration, it is to be understood that such detail is solely for that purpose and that the disclosure is not limited to the disclosed embodiments, but, on the contrary, is intended to cover modifications and equivalent arrangements. For example, it is to be understood that this disclosure contemplates that, to the extent possible, one or more features of any embodiment can be combined with one or more features of any other embodiment.