Electronic plunger assembly

A plunger assembly is configured for slidable advancement through a reservoir of a vessel containing a material to be administered. The plunger assembly includes a plunger rod having a distal end configured to be inserted into the reservoir. An elastomeric plunger extending from the distal end of the plunger rod is configured to sealingly engage a sidewall of the reservoir. At least one printed circuit board is embedded within the plunger, and at least one electronic component is electrically connected with the at least one printed circuit board.

BACKGROUND OF THE DISCLOSURE

The present disclosure is generally directed to plunger assemblies, and, more particularly, to plunger assemblies having a printed circuit board within.

Plungers that are configured for slidable advancement through a reservoir of a vessel containing a material to be administered are commonly used. Generally, plungers are formed of an elastomeric material, enabling slidable advancement of the plunger while maintaining a seal between the plunger the inner sidewall of the reservoir. One drawback of conventional plungers is that they often exhibit a relatively large footprint in return for performing the sole function of providing a seal at a proximal end of a reservoir and assist in ejecting the material from the reservoir.

Generally, the interior of the plunger defines a relatively large, otherwise unused space. Accordingly, there is a need for improved plungers.

BRIEF SUMMARY OF THE DISCLOSURE

Briefly stated, one aspect of the present disclosure is directed to a plunger assembly configured for slidable advancement through a reservoir of a vessel containing a material to be administered. The plunger assembly includes a plunger rod having a distal end configured to be inserted into the reservoir. An elastomeric plunger extending from the distal end of the plunger rod is configured to sealingly engage a sidewall of the reservoir. At least one printed circuit board is embedded within the plunger and secured to the distal end of the plunger rod, and at least one electronic component is electrically connected with the at least one printed circuit board.

Briefly stated, another aspect of the present disclosure is directed to a plunger assembly configured for slidable advancement through a reservoir of a vessel containing a material to be administered. The plunger assembly includes a plunger rod having a distal end configured to be inserted into the reservoir. An elastomeric plunger extending from the distal end of the plunger rod is configured to sealingly engage a sidewall of the reservoir. At least one printed circuit board is embedded within the plunger and at least one electronic component is electrically connected with the at least one printed circuit board. The at least one printed circuit board includes at least one of a via and a recess and at least a portion of the elastomeric plunger is disposed within at least one of the via and the recess.

Briefly stated, another aspect of the present disclosure is directed to an elastomeric plunger positioned stationary within a reservoir of a vessel containing a material to be administered. The plunger is configured to sealingly engage a sidewall of the reservoir and includes at least one printed circuit board embedded within the plunger. At least one electronic component is electrically connected with the at least one printed circuit board, and at least one channel extends through the plunger fluidly connected with the reservoir.

DETAILED DESCRIPTION OF THE DISCLOSURE

Certain terminology is used in the following description for convenience only and is not limiting. The words “lower,” “bottom,” “upper” and “top” designate directions in the drawings to which reference is made. The words “inwardly,” “outwardly,” “upwardly” and “downwardly” refer to directions toward and away from, respectively, the geometric center of the plunger assembly, and designated parts thereof, in accordance with the present disclosure. Unless specifically set forth herein, the terms “a,” “an” and “the” are not limited to one element, but instead should be read as meaning “at least one.” The terminology includes the words noted above, derivatives thereof and words of similar import.

Referring to the drawings in detail, wherein like numerals indicate like elements throughout, there is shown inFIGS. 1-6a plunger assembly10, in accordance with a first embodiment of the present disclosure, configured for slidable advancement through a reservoir of a vessel containing a material to be administered, as will be described in further detail. In one embodiment, the vessel may take the form of a syringe barrel50,150(FIGS. 1, 7) or a cartridge barrel60(FIG. 2), but the disclosure is not so limited. As should be understood by those of ordinary skill in the art, the syringe50,150includes an open proximal end52,152, respectively, having an opening52a,152a,respectively, an opposing distal end54,154, respectively and a reservoir56,156, respectively, therebetween. In one configuration, as shown inFIG. 1, the distal end54may include a connector58, e.g., without limitation, a luer connector. In an alternative configuration, as shown inFIG. 7, the distal end154may include an injection needle158in fluid communication with the reservoir156, but the disclosure is not so limited to either configuration. Similarly to the syringe50,150, and as also should be understood by those of ordinary skill in the art, a cartridge barrel60includes an open proximal end62having an opening62a,an opposing distal end64, and a reservoir66therebetween. In the illustrated configuration, the distal end64is sealed by a stopper68, but the disclosure is not so limited.

As shown inFIG. 1, the plunger assembly10includes a plunger rod12and an elastomeric plunger14connected to a distal end12aof the plunger rod12(as will be described in further detail below). As should be understood, the plunger rod12is configured to be inserted into the reservoir56,156, or66of the vessel50,150, or60(via open end52a,152aor62a), and, in some configurations, to also insert the plunger14into the reservoir56,156or66. The plunger rod12is also configured to advance the plunger14through the reservoir56,156or66in a manner well understood by those of ordinary skill in the art.

As shown inFIGS. 1-6, the elastomeric plunger14may be generally tubular, but the disclosure is not so limited. The elastomeric plunger14is configured to sealingly engage the sidewall of the reservoir56,156, or66when inserted therein. For example, in one non-limiting configuration, the elastomeric plunger14may include a series of radially outwardly protruding circumferential ridges14a.An external diameter of the ridges14amay be sized to create an interference fit with the sidewall of the reservoir56,156, or66, i.e., may be slightly larger than the interior diameter of the reservoir56,156, or66such that the ridges14amay be compressed by the sidewall upon insertion of the plunger14therein to create a sliding sealed engagement. In some embodiments, the elastomeric plunger14may be constructed of a thermoplastic elastomer or a thermoset elastomer, e.g., without limitation, having a Shore A hardness of between 30 and 80. As should be understood, however, the elastomeric plunger14may be constructed of different materials, provided they are capable of performing the functions of the plunger14described herein. Additionally, materials having a low level of particulates, low bioburden/endotoxin, capable of withstanding standard transit conditions may be utilized.

Embedded within the elastomeric plunger14, as shown schematically inFIGS. 3-6, is at least one printed circuit board (“PCB”)16, e.g., multilayered, single layer or a combination thereof. The rigidity of the at least one PCB16serves as a rigid core for the elastomeric plunger14, i.e., operating as a structural backbone of the plunger14. In the illustrated embodiment, three PCBs16in series are embedded within the elastomeric plunger14, but the disclosure is not so limited. That is, one, two or more than three PCBs16may be embedded within the plunger14. In configurations with multiple PCBs16, the PCBs16may be axially spaced apart by spacers15(FIGS. 3, 4), such as, for example, by standoffs. In one embodiment, the standoffs15may be constructed of an electrically conductive material, such as, without limitation, metal, which may assist in providing power, ground or electric communication between the PCBs16. Alternatively, the standoffs15may be constructed of a non-conductive material, such as, without limitation, a polymer. Cables, wires or other conductors (not shown) may be employed to provide electric communication between the PCBs16. Alternatively, the PCBs16may be stacked directly upon one another, i.e., mounted or laminated flush with neighboring PCB(s)16(FIGS. 5, 6). As should be understood by those of ordinary skill in the art, where more than two PCBs16are embedded within the elastomeric plunger14, a combination of stacked and spaced PCBs16may be employed. As also should be understood, the PCBs16may be constructed in varying shapes and sizes with respect to one another.

As shown schematically inFIGS. 3-6, at least one electronic component18may be electrically connected with the at least one PCB16in a manner well understood by those of ordinary skill in the art. For example, without limitation, the electronic component(s)18may take the form of at least one processor, sensor, battery, signal conditioning circuit, receiver/transmitter, memory, a combination thereof, or the like. In the illustrated embodiment, some, or all, of the electronic component(s)18may also be embedded within the elastomeric plunger14. For example, an electronic component18may be mounted upon a PCB16. Alternatively, as shown best inFIGS. 4 and 6, a PCB16having an aperture16atherein, e.g., an annular PCB16, may be employed, and an electronic component18may be placed within the aperture16a.As also should be understood, where more than one PCB16is employed, the different PCBs16may be constructed in differing geometries, for example, to provide spaces for mounting electronic components18. In one non-limiting embodiment, for example, some, or all, of the PCB(s)16may be disk shaped. As also should be understood by those of ordinary skill in the art, multiple electronic components18may be mounted upon a combination of the same or different PCBs16.

The PCB(s)16and the electronic component(s)18may be constructed of materials exhibiting high purity and compatible construction materials to minimize extractable compounds. For example, lead-free solder may be utilized, but the disclosure is not so limited. Embedding the PCB(s)16and the electronic component(s)18within the elastomeric plunger14also minimizes contact with the substance/material within the reservoir56,156or66. The elastomeric plunger14, the PCB(s)16and/or the electronic component(s)18may also be coated to enable stability and substance contact compatibility. Non-limiting examples of coatings include amorphous fluoropolymers, such as CYTOP® manufactured by AGC Chemicals, or poly(p-xylylene) polymers, such as Parylene coatings manufactured by Specialty Coating Systems Inc. Alternatively, other compatible vapor deposited or liquid-based coatings, which provide moisture and/or vapor barriers, may be utilized, in order to protect the substance to be administered within the reservoir and the electronic component(s)18from one other.

The elastomeric plunger14is connected to the distal end12aof the plunger rod12via securement of the PCB(s)16to the distal end12aof the plunger rod12. For example, as shown inFIGS. 3 and 4, the plunger rod12may include at least one mounting rod projecting distally from the distal end12athereof and into engagement with at least one PCB16. In the illustrated embodiment ofFIGS. 3 and 4, the standoffs15also operate as the mounting rods, which project from the distal end12aof the plunger rod12and into engagement with the PCBs16. In one non-limiting configuration, the standoffs15may include respective hooks (seeFIGS. 8, 9) to capture the PCB(s)16and make electrical contact therewith. Alternatively, in another non-limiting configuration, the standoffs15may have deformable locking tabs (not shown) to capture the PCB(s)16. In one non-limiting configuration, the standoffs15may be integrally formed with the plunger rod12, i.e., monolithic therewith, and constructed of the same material, but the disclosure is not so limited. As should be understood, the standoffs15may be utilized to secure the plunger rod12with spaced or stacked PCBs16, or a combination thereof. Conversely, the mountings rods extending from the distal end12aof the plunger rod12and securing the PCBs16may be separate from the standoffs15spacing the PCBs16apart. Additionally, or alternatively, as shown inFIGS. 5 and 6, the PCB(s)16(stacked, spaced or a combination thereof) and/or the elastomeric plunger14may be secured directly to the distal end12of the plunger rod12, e.g., via adhesive or the like.

As should be understood by those of ordinary skill in the art, however, further forms of securement of the PCB(s)16to the plunger rod12, currently known or that later become known, may be employed. For example, a PCB16having an aperture16atherein may be employed, permitting the PCB16to assemble around the distal end12aof the plunger rod12. As other non-limiting examples, the PCB(s)16may be attached to the plunger rod12by press-fitting (not shown) or by threading (not shown). For example, an inner edge of PCBs16with apertures16amay have notches arranged in a helical orientation from board to board to allow the attached PCBs16to be threaded into female threads (not shown) of a plunger rod12. Alternatively, the PCBs16may be keyed (not shown) and slidable into a corresponding notch (not shown) of a plunger rod12.

In one embodiment, the PCB(s)16(with the attached electronic component(s)18) may be co-molded with the elastomeric plunger14, although the elastomeric plunger14may alternatively be molded separately and the PCB(s)16subsequently embedded. When multiple PCBs16are employed, and where some of the PCBs16are spaced apart, elastomer of the elastomeric plunger14may flow around, and between, the PCBs16, i.e., into the spaces between the PCBs16, during the molding process and cure, providing a robust attachment between the PCBs16and the elastomeric plunger14, e.g., prevent movement of the PCBs16relative to the elastomeric plunger14and prevent rotation of the plunger14relative to the PCBs16. As shown best inFIGS. 4 and 6, the PCB(s)16may include at least one via20, e.g., open (a through-hole or channel extending entirely through a PCB16) or blind (a recess within a PCB16having a closed end and an open end). In the illustrated embodiment, several vias20are employed, but the disclosure is not so limited. Such vias20, and/or a central aperture16a,may place the gaps/spaces between PCBs16in fluid communication with one another. In such configurations, elastomer may advantageously also flow through at least a portion of at least one of the vias20during the molding process and cure, further solidifying the securement between the PCBs16and the elastomeric plunger14, as well as potting the electronic component(s)18. That is, the electronic component(s)18may also be positioned within vias20. In alternative configurations, empty gaps/spacing between PCBs16, and/or empty vias20, may be occupied with air, providing a route to sterilize the interior of the elastomeric plunger14with a gas in a manner well understood by those of ordinary skill in the art.

As should be understood by those of ordinary skill in the art, the flow of elastomer between the PCBs16may be accomplished through a variety of traditional processes. Some non-limiting examples include over-molding, injection molding, compression molding, and dip-coating in a low-viscosity polymer mixture (curable or solvent-cast). Alternatively, the PCBs16may be formed into a plunger mold. Additionally, the electronic component(s)18may be assembled into a pre-formed elastomer matrix and rely on either pre-shaped components capable of interpenetrating, or viscoelastic flow of the cured/solidified material into those spaces. To preserve the cleanliness requirements of the finished components, aseptic assembly conditions may be required. As one non-limiting example, the elastomeric component may need to be washed/sterilized separately from the PCB/electronic component and then be assembled prior to use. As should be understood, sterilization options may be selected depending on the PCB(s)16and electronic component(s)18employed. For example, a temperature sensitive PCB(s)16and/or electronic component(s)18may require a compatible sterilization method, such as the use of gamma radiation or ethylene oxide gas rather than steam sterilization.

FIG. 7illustrates a second embodiment of an elastomeric plunger114. The reference numerals of the second embodiment are distinguishable from those of the above-described first embodiment (FIGS. 1-6) by a factor of one-hundred (100), but otherwise indicate the same elements as indicated above, except as otherwise specified. The elastomeric plunger114of the present embodiment is substantially similar to that of the earlier embodiment. Therefore, the description of certain similarities and modes of operation between the embodiments may be omitted herein for the sake of brevity and convenience, and, therefore, is not limiting.

One difference of the elastomeric plunger114shown inFIG. 7over the elastomeric plunger14is that the elastomeric plunger114is not secured or otherwise connected to a plunger rod12. Rather, the elastomeric plunger114may be positioned stationary, i.e., at a fixed location, within the reservoir156of the vessel150. Similarly to the elastomeric plunger14, the elastomeric plunger114is also configured to sealingly engage the sidewall of the reservoir156when inserted therein and includes at least one PCB116embedded within and at least one electronic component118electrically connected with the at least one PCB116. In the illustrated configuration ofFIG. 7, the PCBs116are spaced apart by spacers115, but the disclosure is not so limited (as described with respect to PCBs16). As shown inFIG. 7, the elastomeric plunger114further includes at least one through-channel122, extending through the elastomeric plunger114, fluidly connecting a portion of the reservoir156on one side of the plunger114with a portion of the reservoir156on the opposing side of the plunger114. Rigidity of the plunger114, e.g., provided by the at least one PCB116operating as a rigid core of the plunger114, assists in preventing collapse of the through-channel122due to the pressure within the reservoir156during use.

In one embodiment, an electronic component118of the plunger114may take the form of a flow sensor to capture information on the quantity of material, e.g., medicament, administered, as well as to assist in determining the duration of administration. Non-limiting examples of flow sensors include turbine meters, paddle wheel meters, differential pressure meters (e.g. venturi meter), thermal mass flow meters, elastic filament flow meters and coriolis flow meters or the like. Turbine meters may advantageously provide potential power generation which may be utilized for other electronic components. Electronic sensors, such as elastic filament meters, advantageously lack moving parts, which minimizes potential for malfunction. Elastic filament velocimetry (EFV) may also be advantageous due to the insensitivity of the surface chemistry, thereby being compatible with a variety of coatings/treatments, as well as being low cost and miniature using existing semiconductor fabrication techniques. As should be understood, the flow sensor may be mounted on a PCB116as an inline flow meter (relative to the channel122) or as a side-mounted flow meter (relative to the channel122).

In one configuration, as shown inFIG. 7, the elastomeric plunger114may take the form of a second plunger located within the reservoir156between the plunger14at the distal end12aof the plunger rod12and the distal end of the vessel150, e.g., proximate the distal end of the reservoir156, which, advantageously, is a highly tamper resistant location. The electronic component(s)18of the elastomeric plunger14secured to the distal end of the plunger rod12may be configured to electronically communicate with the electronic component(s)118of the plunger114. For example, as shown inFIG. 7, the electronic component(s)118may operate as a fixed-location component, i.e., positioned within the stationary plunger114, configured to interact with either the moving electronic component(s)18within the plunger14or with external devices (not shown). Generally, the distance therebetween may be calculated as a function of transmitted energy, such as, for example, via magnetic fields, radio frequency, acoustic waves, photons, a combination thereof, or the like. For example, changes in inductance, resonant power transfer, magnetic sensing (e.g., magnet/magnetic material/reed switch in the different plungers14,114), and absorbance differences may be correlated to distance changes, but the disclosure is not so limited. The calculated distance measurement may then be correlated to dosing, for example. In other non-limiting examples, the electronic components18,118may take the form of accelerometers in order to derive spatial information. Employing electronic components18,118, in the two plungers14,114, respectively, enables optical spectroscopy therebetween, i.e., placement of an electronic component operating as a source and another operating as a detector. Advantageously, such configuration may improve signal to noise ratios by decreasing the path length as compared to a system relying on reflection (when utilizing a single plunger). Alternatively, or additionally, optical spectroscopy may be employed within the same plunger. For example, electronic components118may be placed on opposite sides of the channel122of the plunger114and communication as source and detector.

Further advantageously, stationary placement of the elastomeric plunger114within the reservoir156of the vessel150, e.g. a plunger114having a “chevron” shaped cross-section, placed at a distal end of the reservoir156, may also be configured to reduce dead-space within the reservoir156and maximize dosage. For example, as shown inFIG. 7, the proximal end of the elastomeric plunger114is configured, e.g., shaped, to mate with the distal surface of the elastomeric plunger14to minimize dead-space therebetween. Alternatively, without limitation, the proximal end of the elastomeric plunger114and the distal end of the elastomeric plunger14may both be generally planar. Additionally, the distal end of the elastomeric plunger114may also be configured to mate with the distal end of the reservoir156, to further minimize dead-space. Additional advantages of the stationary placement of the elastomeric plunger114include the ability to utilize larger reservoirs156with smaller dosages due to the presence of the plunger114.

FIGS. 8-9illustrate a plunger assembly210according to a third embodiment. The reference numerals of the third embodiment are distinguishable from those of the above-described first embodiment (FIGS. 1-6) by a factor of two-hundred (200), but otherwise indicate the same elements as indicated in the first embodiment, except as otherwise specified. The plunger assembly210of the present embodiment is substantially similar to that of the first embodiment. Therefore, the description of certain similarities and modes of operation between the embodiments may be omitted herein for the sake of brevity and convenience, and, therefore, is not limiting.

One difference of the plunger assembly210shown inFIGS. 8 and 9over the plunger assembly10is that PCB216may take the form of an elongated flexible circuit board. In the illustrated embodiment, the PCB216is foldable onto itself, e.g., in an accordion-like manner, and attachable to the mounting rods215of the plunger rod212. As shown, the mounting rods215may extend through apertures or open vias220that are positioned to become axially aligned when the PCB216is folded. In the illustrated embodiment, the mounting rods215include distal hooks217to capture the PCB216, but the disclosure is not so limited. Other means, currently known or that later become known, may additionally or alternatively be employed to secure the mounting rods215with the PCB216and/or the elastomeric plunger214. As also should be understood by those of ordinary skill in the art, the PCB216may be otherwise wrapped around the distal end of the plunger rod212. Similarly to the elastomeric plunger14, the elastomeric plunger214also includes at least one electronic component218electrically connected with the flexible PCB216.

It will be appreciated by those skilled in the art that changes could be made to the embodiments described above without departing from the broad inventive concepts thereof. For example, the PCB(s) and attached electronic component(s) may be embedded in a tip-cap (not shown), needle shield (not shown), or needle shield cover (not shown). By including these electronic components into drug-contact-components, other than plungers, additional functionality can be realized. For example, for anti-tamper/anti-counterfeit purposes, electronic components in the stopper/tip cap/needle shield could assist by serialization of those components, and, thereafter, record tampering (e.g. attempted refill through the needle/connector), prevent removal from the syringe (e.g. prevent administration), and/or disable the cap for future use (e.g. prevent re-use). Employing the electronic components in an easy-to-access location on the exterior of a syringe may also be advantageous in certain applications. For example, PCB(s) placed in a needle shield or tip cap are generally stabilized at a pre-defined location. Consistent location would facilitate integration with an external device. Such integration could allow for the identification of the drug product, transfer information such as the intended patient, and/or cause a general-purpose administration device to perform a specific administration routine. Additionally, with the electronic components being located on the exterior of a syringe or cartridge, this provides an easier means of power/data transfer (e.g. via exposed contacts). The PCB(s) and attached electronic component(s) may also be embedded in a stopper, and used as an indicator of pharmaceutical integrity (e.g. spectroscopy), and the quality of the environment (e.g. oxygen concentration). It is understood, therefore, that this invention is not limited to the particular embodiments disclosed, but it is intended to cover modifications within the spirit and scope of the present disclosure, as set forth in the appended claims.