Portable, Lanyard- Attachable Pill-Popper Gadget

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S Provisional Patent Application No. 63/381,972, filed November 2, 2022, the contents of which are incorporated by reference herein in its entirety.

BACKGROUND OF THE INVENTION

Healthcare experts have identified the need for a quick and effective method for dispensing pill-form medications from various packaging. Medications are dispensed to patients frequently, and time spent opening medication packaging is significant. In many cases, healthcare workers dispense over 15-20 pills at a time, with each pill having their own unique packaging. Healthcare workers find themselves struggling to open the packaging, sometimes requiring up to 1-2 minutes of ripping and peeling per pill. In some instances, healthcare providers resort to use of implements such as pens and keys to open the packaging, which can lead to problems with medications dropping, spilling and/or sterility.

Current devices designed for opening packaged medication consist of handheld gadgets too large to carry around a healthcare facility, or industrial sized units not intended for healthcare environments. Currently, there is no device that is portable, lanyard attachable, and easy to use that can aid healthcare workers dispense packaged medication. A novel device has the potential to reduce time spent dispensing medication, reduce workplace injury, and increase healthcare productivity, safety and efficiency.

Thus, there is the need in the art for a pill-popper device for quick, safe and efficient dispensing of packaged medication. The present invention meets this need.

SUMMARY OF THE INVENTION

Aspects of the present invention relate to a cutting device including a finger cap having a proximal end and a distal end, a cutting tip positioned at the distal end of the finger cap and extending from the distal end of the finger cap, an opening at the proximal end of the finger cap forming a cavity configured to receive and engage a finger of a user, and a protective container having a proximal end and distal end and an opening at the proximal end forming a cavity with a proximal rim, the cavity sized to fit overtop and engage the finger cap.

In some embodiments, the finger cap is configured to be inserted into the protective container and shift the cutting device between a cutting configuration and a non-cutting configuration. In some embodiments, the device includes an attachment loop positioned at the distal end of the protective container.

In some embodiments, the cutting tip is a blade. In some embodiments, the cutting tip has a width between 1 mm and 5 mm. In some embodiments, the cutting tip has a length between 3 and 8 mm.

In some embodiments, the device includes a puncturing tip positioned on and extending out from the cutting tip. In some embodiments, the puncturing tip extends out a length from the cutting tip between 0.1 mm and 2.0 mm.

In some embodiments, the cavity of the finger cap comprises soft, formfitting material configured to frictionally engage the user’s inserted finger. In some embodiments, a surface of the cavity of the finger cap has smooth regions and/or textured regions. In some embodiments, the surface is configured to create a suction effect to engage and hold onto the inserted finger. In some embodiments, an engagement of the user’s finger within the interior of the finger cap is weaker than an engagement of the finger cap within the protective container.

In some embodiments, the device includes a flange on an outer surface of the finger cap that engages the proximal rim of the protective container. In some embodiments, the flange has an outer diameter that is wider than a diameter of the opening in the protective container.

In some embodiments, the device includes at least one slot in the cavity of the protective container, and at least one tab on an outer surface of the finger cap, wherein the tab is configured to engage the slot to secure the protective container and finger cap together.

In some embodiments, the protective container is configured to be removed to expose at least a portion of the finger cap and cutting tip. In some embodiments, the device includes threads in the cavity of the protective container, and threads on an outer surface of the finger cap, wherein the threads are configured to engage to secure the protective container and finger cap together. In some embodiments, the protective container is configured to rotate to expose at least a portion of the finger cap and cutting tip.

In some embodiments, the protective container further comprises a second opening positioned at the distal end. In some embodiments, at least a portion of the finger cap and/or cutting tip extend through the second opening.

BRIEF DESCRIPTION OF THE DRAWINGS

The following detailed description of embodiments of the invention will be better understood when read in conjunction with the appended drawings. It should be understood, however, that the invention is not limited to the precise arrangements and instrumentalities of the embodiments shown in the drawings.

Fig. 1A, Fig. IB, and Fig. 1C depict exemplary embodiments of a pillpopper device comprising a finger cap and a protective container according to aspects of the present invention.

Fig. 2A and Fig. 2B depict an exemplary embodiment of a finger cap according to aspects of the present invention. Fig. 2A depicts a front perspective view of an exemplary finger cap. Fig. 2B depicts a side view of an exemplary finger cap.

Fig. 2C depicts an exemplary embodiment of a finger cap device having a cutting tip. Fig. 2D depicts an exemplary embodiment of a finger cap having a cutting tip with a distal puncturing tip.

Fig. 3A depicts a side view of an exemplary embodiment of a protective container according to aspects of the present invention. Fig. 3B depicts a bottom perspective view of an exemplary embodiment of a protective container according to aspects of the present invention.

Fig. 4A and Fig. 4B depicts an exemplary embodiment of a pill-popper device worn on a finger of a user according to aspects of the present invention. Fig. 4A shows the finger cap partially inserted into the protective container. Fig. 4B shows the finger cap partially removed from the protective container. Fig. 5 shows medication packaging opened with a pill popper device according to aspects of the present invention.

Fig. 6 shows the results of a survey.

DETAILED DESCRIPTION

It is to be understood that the figures and descriptions of the present invention have been simplified to illustrate elements that are relevant for a clear understanding of the present invention, while eliminating, for the purpose of clarity many other elements found in the field of the present invention. Those of ordinary skill in the art may recognize that other elements and/or steps are desirable and/or required in implementing the present invention. However, because such elements and steps are well known in the art, and because they do not facilitate a better understanding of the present invention, a discussion of such elements and steps is not provided herein. The disclosure herein is directed to all such variations and modifications to such elements and methods known to those skilled in the art.

Definitions

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention pertains. Although any methods and materials similar or equivalent to those described herein can be used in the practice for testing of the present invention, exemplary materials and methods are described herein. In describing and claiming the present invention, the following terminology will be used.

It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting.

The articles “a” and “an” are used herein to refer to one or to more than one (i.e., to at least one) of the grammatical object of the article. By way of example, “an element” means one element or more than one element.

“About” as used herein when referring to a measurable value such as an amount, a temporal duration, and the like, is meant to encompass variations of ±20%, ±10%, ±5%, ±1%, or ±0.1% from the specified value, as such variations are appropriate. The terms “patient,” “subject,” “individual,” and the like are used interchangeably herein, and refer to any animal amenable to the systems, devices, and methods described herein. The patient, subject or individual may be a mammal, and in some instances, a human.

Ranges: throughout this disclosure, various aspects of the invention can be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as from 1 to 6 should be considered to have specifically disclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6 etc., as well as individual numbers within that range, for example, 1, 2, 2.7, 3, 4, 5, 5.3, and 6. This applies regardless of the breadth of the range.

Pill-Popper Device

The disclosed pill popper device, in some examples referred to as a cutting device, provides a safe and user-friendly device that can be easily attached to a lanyard and carried by a person, such as by a healthcare provider in a hospital or clinic setting where medication is being dispensed.

Referring now to Fig. 1A, Fig. IB, and Fig. 1C, shown are various exemplary embodiments of a pill popper device or cutting device 100 according to aspects of the present invention. Device 100 generally includes a finger cap 10 and a protective container 20, however in some embodiments, device 100 may comprise only a finger cap 10. Further, although finger cap 10 and protective container 20 are shown as being formed as separate units or components, it should be appreciated that finger cap 10 and protective container 20 may be formed as a single unit or component.

Referring now to Fig. 2A and Fig. 2B, an exemplary finger cap 10 is shown. Finger cap 10 includes a body 12 having a proximal end 13 and a distal end 14, a flange region 15 extending from the proximal end 13 of body 12 and forming a ridge 16, and a cutting tip 18 attached to, and extending from the distal end 14 of body 12. Finger cap 10 also includes a cavity or opening 17 at the proximal end 13 of body 12 forming an interior surface and an exterior surface of body 12. It should be appreciated that opening 17 is sized to fit securely overtop a person’s finger.

As contemplated herein, body 12 may be any desired shape provided opening 17 is sized to permit the insertion of a person’s finger and body 12 fits securely overtop the inserted finger, such that finger cap 10 does not slip off the inserted finger during use. For example and without limitation, body 12 may be cylindrical, cuboidal, spherical, hemispherical, pyramidal, ovoidal, ellipsoidal or any other desired shape. In some embodiments, body 12 is shaped like a sewing thimble. In some embodiments, the proximal end 13 of body 12 may include an opening, such that at least a portion of a person’s finger when inserted into opening 17 may pass through the proximal opening. The exterior surface of body 12 may be smooth, textured, or combinations of smooth regions and textured regions. Example exterior surface textures may include, without limitation, grooves, ridges, threads, bumps, divots and the like. Likewise, the interior surface of body 12 may be smooth, textured, or combinations of smooth regions and textured regions. Example interior surface textures may include, without limitation, grooves, ridges, threads, bumps, divots and the like.

In some embodiments, body 12 may be rigid, flexible, elastic, or combinations thereof, such that portions of body 12 are rigid while other portions are flexible and/or elastic. Body 12 may be composed of any material having these characteristics, including for example any organic or inorganic polymers, plastics, silicon, rubber, metal, magnetic materials, polylactic acid (PLA), nylon, thermoplastic polyurethane (TPU), and the like. In some embodiments, body 12 may have an exterior surface that is more rigid, while the inner surface is more soft. For example, the inner surface may include a soft silicon material to create a form fitting, friction hold on a person’s finger when inserted through opening 17. Further, the exterior surface may include a rigid plastic configured to securely attach cutting tip 18 and further capable of releasably engaging protective container 20. In other embodiments, the inner surface is more rigid, while the exterior surface is more soft and pliable.

In some embodiments, body 12 has a length of about 0.5” to 1.5” (about 10 mm to 40 mm). In some embodiments, body 12 has a length of about 1.5” to 2.5” (about 35 mm to 65 mm). In some embodiments, body 12 has a length of about 2.5” to 3” (about 65 mm to 80 mm). In some embodiments, body 12 has a width or diameter of about 0.5” to 1.5” (about 10 mm to 40 mm). In some embodiments, body 12 has a width or diameter of about 0.75” to 1.25” (about 15 mm to 30 mm). In some embodiments, body 12 has a width or diameter of about 1.00” to 1.5” (about 25 mm to 40 mm).

Finger cap 10 may optionally include a flange region 15 at the proximal end 13 of body 12. In some embodiments, flange region 15 extends radially outward from body 12, such that flange region 15 has a larger outer diameter than body 12. In some embodiments, flange region 15 thus forms a ridge 16, which may be of any desired size and angle extending from the outer surface of body 12. Ridge 16 may serve as a stop for the proximal rim 26 of protective container 20 to make contact with when protective container 20 is fit overtop finger cap 10. In some embodiments, ridge 16 of flange region 15 may optionally include other features, such as a recess configured to engage rim 26, or any other textured surface feature suitable for engaging rim 26 of protective container 20. Flange region 15 may form a single unit with body 12, or it may be separate component that is attachable to body 12. Flange region 15 may be rigid, flexible, elastic, or any combinations thereof. The exterior surface of flange region 15 may be smooth, textured, or combinations of smooth regions and textured regions. Example exterior surface textures may include, without limitation, grooves, ridges, bumps, divots and the like. Likewise, the interior surface of flange region 15 may be smooth, textured, or combinations of smooth regions and textured regions. Example interior surface textures may include, without limitation, grooves, ridges, bumps, divots and the like.

Cutting tip 18 extends from a region of the exterior surface of body 12 and is generally sturdy, such that when a person’s finger is inserted into opening 17 and cutting tip 18 is positioned on a medication packaging surface, the person can apply a pushing force to cut the medication packaging. Cutting tip 18 may be configured in various orientations to provide a distal puncturing, cutting or piercing tool for finger cap 10. For example, cutting tip 18 may extend upward from the distal end 14 of body 12. In other embodiments, cutting tip 18 may extend outward from a distal region of body 12 at any desired angle. In some embodiments, cutting tip 18 forms a single unit with body 12, while in other embodiments cutting tip 18 is a separate component and is separately attachable to body 12.

In some embodiments, cutting tip 18 has a length extending from body 12 of about 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, or about 10 mm. In some embodiments, cutting tip 18 has a width of about 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, or about 10 mm, or between 1 mm and 5 mm. In some embodiments, cutting tip 18 has a total length of about 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, or about 10 mm, or between 3 mm and 8 mm.

It should be appreciated that cutting tip 18 may be straight, curved or any desired shape, or comprise one or more puncturing features or tips extending out from the cutting tip. For example, referring now to Fig. 2C and Fig. 2D, in some embodiments cutting tip 18 may include a puncturing tip 30 extending out from the distal end of cutting tip 18. In some embodiments, puncturing tip 30 extends out from cutting tip 18 about 0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1 mm, 1.1 mm, 1.2 mm, 1.3 mm, 1.4 mm, 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, or 2.0 mm. In some embodiments, puncturing tip 30 may be straight, curved or any desired shape. For example, in some embodiments, puncturing tip 30 extends out straight from cutting tip 18 about 1.0 mm and is at least partially formed in a round shape.

In some embodiments, cutting tip 18 may be retractable within body 12 or within cutting tip 18. In some embodiments, puncturing tip 30 is slidably inserted into cutting tip 18, and a portion of puncturing tip 30 extends out from cutting tip 18 when a finger is placed into the opening of finger cap 10, or when pressure is applied to cutting tip 18, and puncturing tip 30 recedes back into cutting tip 18 when the finger is removed, or when pressure is released. In some embodiments, cutting tip 18 and puncturing tip 30 are connected via a plunger and spring mechanism positioned in the distal end of body 12. In some embodiments, cutting tip 18 may be hingedly attached to body 12 in a manner such that cutting tip 18 includes a cutting position and a non-cutting position. Cutting tip 18 may be composed of any material suitable for forming a sturdy, sharp tip. Exemplary materials include, without limitation, metals, polymers, plastics and the like.

Referring to Fig. 3A and Fig. 3B, shown is an exemplary embodiment of a protective container 20 according to aspects of the present invention. Protective container 20 includes a body 22 having a proximal end 24 and a distal end 23, a distal attachment mechanism 25, a proximal rim 26, and a cavity or opening 27 forming an inner surface and outer surface of body 22. It should be appreciated that opening 27 is sized to fit securely overtop of finger cap 10.

As contemplated herein, body 22 may be any desired shape provided opening 27 is sized to permit the insertion of finger cap 10 when stored, such that cutting tip 18 of finger cap 10 is sufficiently covered and prohibited from unintentional cutting. For example, and without limitation, body 22 may be cylindrical, cuboidal, spherical, hemispherical, pyramidal, ovoidal, ellipsoidal or any other desired shape. In some embodiments, body 22 is the same shape as body 12. In some embodiments, body 22 is a different shape than body 12. The exterior surface of body 22 may be smooth, textured, or combinations of smooth regions and textured regions. Example exterior surface textures may include, without limitation, grooves, ridges, threads, bumps, divots and the like. Likewise, the interior surface of body 22 may be smooth, textured, or combinations of smooth regions and textured regions. Example interior surface textures may include, without limitation, grooves, ridges, threads, bumps, divots and the like.

In some embodiments, body 22 may be rigid, flexible, elastic, or combinations thereof, such that portions of body 22 are rigid while other portions are flexible and/or elastic. Body 22 may be composed of any material having these characteristics, including for example any organic or inorganic polymers, plastics, silicon, rubber, metal, magnetic materials, polylactic acid (PLA), nylon, thermoplastic polyurethane (TPU), and the like. In some embodiments, body 22 may have an exterior surface that is more rigid, while the inner surface is more soft. For example, the inner surface may include a soft silicon material to create a form fitting, friction hold on finger cap 10 when inserted through opening 27. In other embodiments, the inner surface is more rigid, while the exterior surface is more soft and pliable.

In some embodiments, body 22 has a length of about 0.5” to 1.5” (about 10 mm to 40 mm). In some embodiments, body 22 has a length of about 1.5” to 2.5” (about 35 mm to 65 mm). In some embodiments, body 22 has a length of about 2.5” to 3” (about 65 mm to 80 mm). In some embodiments, body 12 has a width or diameter of about 0.5” to 1.5” (about 10 mm to 35 mm). In some embodiments, body 22 has a width or diameter of about 0.75” to 1 .0” (about 15 mm to 25 mm). In some embodiments, body 22 has a width or diameter of about 0100” to 1.5” (about 25 mm to 40 mm).

In some embodiments, protective container 20 may optionally include a distal attachment mechanism 25. Distal attachment mechanism 25 may include, without limitation, a ring extension, a handle, one or more holes, or any other structure suitable for attaching a string, lanyard, ID card, door pass, key chain or other device for convenient portability.

Opening 27 forms a proximal rim 26 on body 22. Proximal rim 26 is sized such that it may engage ridge 16 of flange region 15 of finger cap 10. In some embodiments, and as shown in Figs. 4A and 4B, ridge 16 simply forms a stop, such that when rim 26 hits ridge 16, protective container 20 cannot advance any further overtop finger cap 10. In other embodiments, rim 26 and ridge 16 may include an engagement mechanism to releasably secure protective container 20 overtop finger cap 10 in a stored configuration. Exemplary engagement mechanisms include, without limitation, a friction fit, depressible buttons, detents, screw threads, magnets and the like.

In some embodiments, the interior surface of body 12 of finger cap 10 may be a soft, form-fitting material that frictionally engages a person’s inserted finger and/or creates a suction effect to engage and hold onto the inserted finger. Further, the inner diameter of opening 27 and the inner surface of body 22 of protective container 20 is slightly larger than the outer diameter of body 12 of finger cap 10, thereby forming a friction fit of finger cap 10 within protective container 20. With this configuration, the engagement of a person’s finger within the interior of finger cap 10 is stronger than the engagement of finger cap 10 within protective container 20, thereby permitting a person to insert their finger into finger cap 10 when finger cap 10 is stored within protective container 20, and pull away such that finger cap 10 disengages from protective cap 20 while finger cap 10 remains on the person’s finger. Likewise, the person can reinsert finger cap 10 into protective container 20 while finger cap 10 is still engaged on the person’s finger, and simply hold the protective container 20 and flange region 15 of finger cap 10 to disengage their finger from finger cap 10, thereby returning finger cap 10 to its stored position within protective container 20. In other embodiments, the engagement of a person’s finger within the interior of finger cap 10 is weaker than the engagement of finger cap 10 within protective container 20. For example, finger cap 10 when inserted into protective container 20 may engage via threads or a pin and groove. Accordingly, a person can insert their finger into finger cap 10 when finger cap 10 is stored within protective container 20, and initiate a quarter or half turn to disengage protective cap 10 and pull out from protective container 20. Likewise, the person can reinsert finger cap 10 into protective container 20 while finger cap 10 is still engaged on the person’s finger, and simply initiate the quarter or half turn to reengage protective cap and pull their finger out, leaving finger cap 10 again in the stored position.

Referring now to Fig. IB, shown is an exemplary embodiment of device 100 wherein the device includes a pin and groove structure for fixedly and removably attaching the finger cap and the protective container. Referring now also to Fig. 2C and Fig. 2D, flange region 15 may comprise one or more protrusions 19 extending outward from the exterior surface of body 12 forming the pins for the pin and groove structure. In some embodiment, each protrusion of the one or more protrusions 19 are equally spaced around the exterior surface of body 12. Protrusions 19 can be any shape, for example spherical, hemispherical, cubic, cuboidal and the like. In some embodiments, protrusions 19 are made of the same material as body 12, and in other embodiments, protrusions 19 can be made of a different material from body 12. For example, protrusions 19 may be more rigid, stiff or smooth when compared to the rest of body 12 or flange region 15. Protrusions 19 can be made of any material that can easily slide through a rigid groove, including but not limited to plastic, metal, organic and non-organic polymers and the like.

Referring now also to Fig. 3A and Fig. 3B, shown is an exemplary embodiment of a protective container 20 comprising grooves for the pin and groove structure. In some embodiments, protective container 20 comprises one or more grooves 29 on the inside surface of body 22, each groove having a proximal opening, and a distal stop. It should be appreciated that the position of each proximal opening of grooves 29 aligns with each protrusion 19 of finger cap 12. Grooves 29 may be equally spaced around the circumference of body 22, similar to protrusions 19 on body 12. Grooves 29 can be made of the same material as body 22, or grooves 29 can be made of a different material from body 22. For example, grooves 29 may be more firm and slick when compared to the rest of body 22. In another example, grooves 29 may be composed of the same material as protrusions 19. Grooves 29 can be made of any rigid material that will allow protrusions 19 to easily slide within the groove, between the proximal opening and distal stop.

Again referring to Fig. IB, the shown device 100 comprises an exemplary retention mechanism (e.g., slot and groove) for finger cap 10 and protective container 20. In some embodiments, the retention mechanism fixedly and releasably secures the cap and container together using protrusions 19 and grooves 29. In an exemplary method of use, when a user wishes to secure finger cap 10 into protective container 20, the user inserts their finger into finger cap 10 and aligns the protrusions 19 to the proximal openings of grooves 29. The user slides finger cap 10 into protective container 20 such that each protrusion 19 slides into its respective groove. Once finger cap 10 is inserted into protective container 20, the user then rotates protective container 20 in a counterclockwise direction, in order to slide protrusions 19 laterally within grooves 29. Finger cap 10 is locked within protective container 20 when protrusions 19 make contact with the distal stops of grooves 29. In order to remove finger cap 10 from protective container 20, the user again inserts their finger into finger cap 10, and rotates protective container 20 clockwise, and then pulls proximally on finger cap 10 to disengage finger cap 10 from protective container 20.

In another embodiment and referring back to Fig. 1C, protective container 20 includes a slit or opening 28 that cutting tip 18 can pass through. In some embodiments, finger cap 10 can be inserted into protective container 20 and then shift between a cutting position and a non-cutting position. For example, finger cap 10 can be in the stored, noncutting position when it is shifted proximally within protective container 20. In this stored, non-cutting position, cutting tip 18 is hidden inside distal end 23 of protective container 20. To shift into a cutting position, a person inserts their finger into finger cap 10, pushes distally, and cutting tip 18 advances through opening 28 and is in the distal cutting position because finger cap 10 is shifted distally within protective container 20.

When the person is done cutting the medicine packaging, they pull their finger out, which shifts finger cap 10 proximally and holds in place, allowing the finger to be pulled out of finger cap 10. The shift between the proximal, non-cutting position and the distal, cutting position may proceed by an insert and twist motion. Then by twisting the finger cap, you can disengage it entirely to wash it or replace the cutting tip, etc. EXPERIMENTAL EXAMPLES

The invention is further described in detail by reference to the following experimental examples. These examples are provided for purposes of illustration only, and are not intended to be limiting unless otherwise specified. Thus, the invention should in no way be construed as being limited to the following examples, but rather, should be construed to encompass any and all variations which become evident as a result of the teaching provided herein.

Without further description, it is believed that one of ordinary skill in the art can, using the preceding description and the following illustrative examples, make and utilize the present invention and practice the claimed methods. The following working examples therefore are not to be construed as limiting in any way the remainder of the disclosure.

Example 1 : Dispensing Packaged Medication

Now referring to Fig. 5, medication packages for 3 different pills were opened with device 100. The device punctures the pill packaging with the sharp edge of a cutting tip. The edge of the cutting tip may also be used to pop or scoop out the desired pill. Fig. 5 displays the results of using the cutting tip of an exemplary device 100 to puncture and/or cut the foil backing of a pill packaging.

Example 2: Survey Results

Healthcare experts frequently dispensing medication were surveyed with questions to determine the clinical need of a medication packaging cutting device. Now referring to Fig. 6, shown are the results of the survey.

The disclosures of each and every patent, patent application, and publication cited herein are hereby each incorporated herein by reference in their entirety. While this invention has been disclosed with reference to specific embodiments, it is apparent that other embodiments and variations of this invention may be devised by others skilled in the art without departing from the true spirit and scope of the invention. The appended claims are intended to be construed to include all such embodiments and equivalent variations.