Compound injection apparatus

Abstract

An apparatus for single or compound medication injection and a method of use thereof is described herein. The injection apparatus includes a syringe including a barrel, a hub mounted to an end of the barrel, a plunger slidably mounted in the barrel. The injection apparatus includes a first cartridge and a second cartridge operably connected to one another within the barrel of the syringe. The plunger is configured to actuate the first and second cartridges by compressing the first and second cartridges from a first position to a second position. In the first position, a first fluid is contained within the first cartridge and a second fluid is contained within the second cartridge. In the second position, at least a portion of the first fluid and at least a portion of the second fluid mix and are dispensed from the syringe.

Description

COMPOUND INJECTION APPARATUSCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to US Provisional Patent Application No. 63 / 609,447, filed on December 13, 2023, incorporated herein by reference in its entirety.BACKGROUND

[0002] Drug compounding involves combining two or more medicaments to create a medication tailored to the needs of a patient. For example, to treat an inflammatory process, orthopedic surgeons often create a medication by mixing local anesthetics with non-steroid antiinflammatory medicaments and steroids. Drug compounding is practiced across all medical specialties and is performed in various locations ranging from clinics to operating rooms. Typically, each medicament is drawn from a respective vial and loaded into a single syringe, such that the medication is ready to be injected by a physician.

[0003] Previously, registered nurses and medical assistants were allowed to compound multiple medicaments into a single syringe. However, current state nursing board guidelines prevent registered nurses from compounding medication. For example, Section 2725 of the CALIFORNIA NURSING PRACTICE ACT indicates that “[n]o registered nurse shall compound drugs.” Moreover, healthcare institutions have adopted policies prohibiting compounding by medical assistants. For instance, University of California Los Angeles (UCLA) policies AMB 130 and AMB 143 indicate that “in every instance, prior to the administration of medicine by a medical assistant, a licensed physician or podiatrist, or another appropriately licensed person shall verify the correct medication and dosage. Medications may not be compounded.” In practical terms, to comply with current drug compounding guidelines, either physicians draw their own medications prior to injecting the medication, or medical assistantsand registered nurses draw each medication into separate plastic containers, after which the physician mixes all of the medicaments and places the mixture into a single syringe. In either scenario, compounding medicaments in accordance with current drug compounding guidelines is impractical and time consuming, particularly when a typical four-hour clinic may have up to 20- 30 patients receiving such injections.

[0004] Thus, there is a need in the art for improved medicament delivery systems. The present invention satisfies this need.SUMMARY

[0005] The present disclosure relates generally to injectors for medicaments and other fluids, and more particularly, to an apparatus for single or compound medication injection.

[0006] In one or more cases, a compound injection apparatus includes a syringe including a barrel, a hub mounted to an end of the barrel, a plunger slidably mounted in the barrel. In one or more cases, the compound injection apparatus includes a first cartridge and a second cartridge operably connected to one another within the barrel of the syringe. In one or more cases, the plunger is configured to actuate the first and second cartridges by compressing the first and second cartridges from a first position to a second position. In one or more cases, in the first position, a first fluid is contained within the first cartridge and a second fluid is contained within the second cartridge. In one or more cases, in the second position, at least a portion of the first fluid and at least a portion of the second fluid mix and are dispensed from the syringe.

[0007] In one or more cases, a fluid compounding system includes a first cartridge comprising a compressible body disposed between a rigid first end and a rigid second end comprising a first port. In one or more cases, the fluid compounding system includes a second cartridge comprising a compressible body disposed between a rigid third end comprising asecond port and a rigid fourth end comprising a third port. In one or more cases, the second port of the second cartridge is operably connected to the first port of the first cartridge. In one or more cases, in a first position, the first port and the second port are sealed such that a first fluid is contained within the first cartridge and a second fluid is contained within the second cartridge. In one or more cases, in a second position, the first port and the second port are open such that one or both of the first fluid and second fluid pass through the first and second ports.

[0008] A variety of additional aspects will be set forth in the description that follows. The aspects can relate to individual features and to combination of features. It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the broad inventive concepts upon which the embodiments disclosed herein are based.BRIEF DESCRIPTION OF THE DRAWINGS

[0009] The following drawings are illustrative of particular embodiments of the present disclosure and therefore do not limit the scope of the present disclosure. The drawings are not to scale and are intended for use in conjunction with the explanations in the following detailed description.

[0010] Figure 1 is a perspective view of an example compound injection apparatus.

[0011] Figure 2 is an exploded view of the compound injection apparatus of Figure 1.

[0012] Figure 3 is a perspective view of an example cartridge.

[0013] Figure 4 is a perspective view of an example cartridge stack.

[0014] Figure 5A is a side view of an example compound injection apparatus in a loaded position.

[0015] Figure 5B is a side view of the example compound injection apparatus of Figure 5A in a dispensed position.

[0016] Figure 6 is a perspective view of an example safety needle cap coupled to an example compound injection apparatus.

[0017] Figure 7A is a perspective view of an example image scanning apparatus.

[0018] Figure 7B is a perspective view of the image scanning apparatus of Figure 7A coupled with the example compound injection apparatus of Figure 5 A.

[0019] Figure 8A is a perspective view of an example cartridge.

[0020] Figure 8B is a side view of an example capsule of the example cartridge of Figure 8A.

[0021] Figure 8C is a cross-sectional view taken along section A-A of the example capsule.

[0022] Figure 8D is a top view of an example cap of the example cartridge of Figure 8A.

[0023] Figure 8E is a side view of the example cap.DETAILED DESCRIPTION

[0024] The following discussion omits or only briefly describes conventional features of injectors that are apparent to those skilled in the art. It is noted that various embodiments are described in detail with reference to the drawings, in which like reference numerals represent like parts and assemblies throughout the several views. Reference to various embodiments does not limit the scope of the claims attached hereto. Additionally, any examples set forth in this specification are intended to be non-limiting and merely set forth some of the many possible embodiments for the appended claims. Further, particular features described herein can be used in combination with other described features in each of the various possible combinations and permutations.

[0025] Unless otherwise specifically defined herein, all terms are to be given their broadest reasonable interpretation including meanings implied from the specification as well as meanings understood by those skilled in the art and / or as defined in dictionaries, treatises, etc. It is noted that, as used in the specification and the appended claims, the singular forms “a,” “an” and “the” include plural referents unless otherwise specified, and that the terms “includes” and / or “including,” when used in this specification, specify the presence of stated features, elements, and / or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof.

[0026] Relative terms such as “horizontal,” “vertical,” “up,” “down,” “top,” and “bottom” as well as derivatives thereof (e.g., “horizontally,” “downwardly,” “upwardly,” etc.) should be construed to refer to the orientation as then described or as shown in the drawing figure under discussion. These relative terms are for convenience of description and normally are not intended to require a particular orientation. Terms including “inwardly” versus “outwardly,” “longitudinal” versus “lateral” and the like are to be interpreted relative to one another or relative to an axis of elongation, or an axis or center of rotation, as appropriate. Terms concerning attachments, coupling and the like, such as “connected” and “interconnected,” refer to a relationship wherein structures are secured or attached to one another either directly or indirectly through intervening structures, as well as both movable or rigid attachments or relationships, unless expressly described otherwise. The term “operatively or operably connected” is such an attachment, coupling or connection that allows the pertinent structures to operate as intended by virtue of that relationship.

[0027] Reference throughout the specification to “one embodiment”, “an embodiment” or“some embodiments” means that a particular feature, structure, or characteristic described inconnection with an embodiment is included in at least one embodiment of the subject matter disclosed. Thus, the appearance of the phrases “in one embodiment”, “in an embodiment” or “in some embodiments” in various places throughout the specification is not necessarily referring to the same embodiment. Further, the particular features, structures or characteristics of “one embodiment”, “an embodiment” or “some embodiments” may be combined in any suitable manner with each other to form additional embodiments of such combinations. It is intended that embodiments of the disclosed subject matter cover modifications and variations thereof. Terms such as “first,” “second,” “third,” etc., merely identify one of a number of portions, components, steps, operations, functions, and / or points of reference as disclosed herein, and likewise do not necessarily limit embodiments of the present disclosure to any particular configuration or orientation.

[0028] Moreover, 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, 6, and any whole and partial increments there between. This applies regardless of the breadth of the range. As used herein, the term “about” in reference to a measurable value, such as an amount, a temporal duration, and the like, is meant to encompass the specified value and / or variations of plus or minus 20%, plus or minus 10%, plus or minus 5%, plus or minus 1%, andplus or minus 0.1% of the specified value, as such variations are appropriate. Furthermore, the terms “medicament”, “medication”, or “fluid” as used herein refers to any substance for delivery to a target. For example, these terms include anticoagulants, vaccines, biologies, saline, nonsteroidal anti-inflammatory drugs, or any other injectable fluids.

[0029] Conventional methods of compounding medication are generally cumbersome, let alone time consuming. Under current drug compounding guidelines, physicians must draw their own medications prior to injection or mix the medications into a single syringe by drawing the medications from separate containers that were previously filled by an assistant. Embodiments of the present disclosure relate generally to injectors for medicaments and other fluids, and more particularly, to a single or compound injection apparatus. The injection apparatus may be configured to hold multiple cartridges that individually contain medicament or other fluid within the respective cartridges. As such, an assistant may pre-load the injection apparatus with specific medications and dosages, without the assistant mixing or compounding the medications.

[0030] The compound injection apparatus may be configured to avoid compounding the medicaments or other fluids within the respective cartridges until the medication is dispensed via the injection apparatus. The medications within the individual cartridges remain sealed until a physician depresses the plunger of the syringe, thereby pushing on the end of the cartridges loaded into the syringe. The depressing plunger compacts the cartridges opening or rupturing the valves between cartridges due to the increased fluid pressure. As such, the medications within the cartridges begin to mix, and the physician efficiently compounds the medications consistent with current drug compounding guidelines. Embodiments of the injection apparatus are described below with reference to the Figures.

[0031] FIG. 1 is a perspective view of an example compound injection apparatus 100(hereinafter “apparatus 100”). FIG. 2 is an exploded perspective view the of the apparatus 100. The apparatus 100 includes a delivery assembly 102, a barrel assembly 104, and a plunger 108. The barrel assembly 104 is configured to house a cartridge stack 106. The cartridge stack 106 includes a plurality of cartridges, such as a first cartridge 202a, a second cartridge 202b, and a third cartridge 202c, as illustrated in FIG. 2. Each cartridge is configured to contain a fluid. At least a portion of the plunger 108 is configured to axially translate within a portion of the barrel assembly 104. For example, a plunger seal 110 may be disposed on a proximal end 201 of the plunger 108. The plunger seal 110 is configured to contact an end of the cartridge stack 106 and compress the cartridge stack 106 while axially translating within the barrel assembly 104. As the cartridge stack 106 compresses, the cartridge stack 106 provides fluid from the cartridge stack 106 to the delivery assembly 102.

[0032] The plunger 108 includes a rigid body 218 disposed between an end fitting 216 and the plunger seal 110. The plunger seal 110 is disposed on the proximal end 201 of the body 218. The plunger seal 110 is sized to snuggly fit within a barrel 208 of the barrel assembly 104, such that the plunger seal 110 may axially translate within the barrel 208. The plunger seal 110 is sized to prevent air or other gases from entering a cavity of the barrel 208. In some cases, the plunger seal 110 may be removably coupled to the proximal end 201 of the body 218. For example, as illustrated in FIG. 2, the proximal end 201 of the body 218 may include a connecting member 220 that is rigid body configured to couple with the plunger seal 1 10. For instance, the plunger seal 110 and connecting member 220 may be press-fit onto one another. In another instance, the plunger seal 110 and connecting member 220 may be threaded onto one another. Inother cases, the plunger seal 110 may be fixed to the proximal end 201 of the body 218, such that the plunger seal 110 is permanently attached to the body 218.

[0033] The end fitting 216 is a rigid body disposed on the distal end 203 of the body 218.The end fitting 216 provides an area for a user to press against to depress the plunger 108 in the barrel assembly 104. The end fitting 216 may be formed in a variety of shapes. For instance, the end fitting 216 may be formed in a ring-like shape. In another instance, the end fitting 216 may be formed with a flanged end having a planar or curved surface. In yet another instance, the end fitting 216 may be formed to have an ergonomic shape.

[0034] In one or more cases, the barrel assembly 104 includes the barrel 208 disposed between a contact member 210 and a coupling member 212. The barrel 208 may be a rigid hollow body sized to receive at least a portion of the plunger 108, such as the plunger seal 110.In one or more cases, the barrel 208 may be formed of a transparent or semi-transparent material, such that the interior cavity of the barrel 208 is visible when viewed from the exterior of the barrel 208. The contact member 210 may be a rigid body formed in a flanged shape. The contact member 210 may provide a user with an area to grasp with the user’s fingers in order to depress the plunger 108 into the barrel 208 by pressing the end fitting 216. The coupling member 212 is configured to couple with a portion of the needle assembly 102, such as the coupling member 226. An end portion 228 of the coupling member 226 may be mated to an end portion 214 of the coupling member 212, thereby coupling the delivery assembly 102 to the barrel assembly 104. For example, the end portion 214 and the end portion 228 may be threaded onto one another.

[0035] In one or more cases, the delivery assembly 102 includes the coupling member 226, a port 227, and hub 230. The port 227 may be a hollow body disposed within the coupling member 226 to align with a port, such as port 204, of the cartridge stack 106 when the apparatus 100 isassembled. The port 227 may be configured to interface with the port 204 of the cartridge stack 106 to allow fluid to flow from the cartridge stack 106 through the hub 230. In some cases, the hub 230 is configured to receive a needle, such as the needle 224. A protective cover 222 may be removably coupled to the hub 230 and positioned over the needle 224. In other cases, the hub 230 is configured to receive a connector, such as, but not limited to, a Luer slip, Luer lock, and the like.

[0036] The cartridge stack 106 includes a plurality of cartridges, such as a first cartridge 202a, a second cartridge 202b, and a third cartridge 202c. The cartridge stack 106 is configured to contain an individual fluid within each cartridge. For instance, the first cartridge 202a contains a first fluid, the second cartridge 202b contains a second fluid, and the third cartridge 202c contains a third fluid. It is noted that the example of the cartridge stack 106 discussed herein includes three cartridges. However, it should be understood that the cartridge stack 106 may also include, for example, two cartridges or more than three cartridges. Further, it should be understood that one cartridge may be used in a same or similar manner as the cartridge stack 106 in the apparatus 100 to provide a fluid to the delivery assembly 102.

[0037] In one or more cases, the plurality of cartridges of the cartridge stack 106 may be arranged in series and operably coupled to one another, such that fluid may pass from one cartridge to another when the cartridge stack 106 is compressed. A first end cartridge, such as the first cartridge 202a, in the series of cartridges may include a port, such as port 204, configured to be operably coupled to port 227 of the delivery assembly 102. The mixture of fluids of the cartridge stack 106 may pass through the port 204 of the end cartridge and into the delivery assembly 102. A second end cartridge, such as the third cartridge 202c, is disposed on the opposite end of the cartridge stack 106 from the first end cartridge, such as the first cartridge202a. In one or more cases, the second end cartridge includes a rigid rear end 206 having a planar or substantially planar surface that is configured to interface with a portion of the plunger 108, such as the plunger seal 110.

[0038] The cartridge stack 106 is configured to mix the fluids contained within the cartridge stack 106 as the cartridge stack 106 is compressed. The cartridge stack 106 is configured to pass the mixed fluids through the delivery assembly 102. For example, when the plunger 108 is depressed within the barrel assembly 104, an end of the plunger 108, such as the plunger seal 110, contacts the rear end 206 of the cartridge stack 106, creating fluid pressure. As the plunger 108 compresses the cartridge stack 106 towards the delivery assembly 102, the fluid pressure causes the fluid within each cartridge to move towards the delivery assembly 102, thereby mixing at least a portion of the fluids contained within the cartridge stack 106. The fluid pressure causes the fluid to pass from the cartridge stack 106 through the hub 230 of the delivery assembly 102 via ports 227 and 204.

[0039] FIG. 3 is a perspective view of an example cartridge 300. The cartridge 300 has a compressible body 306 disposed between a base 302 and a base 304. In one or more cases, the cartridge 300 includes ports, such as ports 308 and 310, disposed on each of base 302 and base 304. In one or more other cases, the cartridge 300 includes a port only on one base of the cartridge. For example, cartridge 202c, illustrated in FIG. 4, includes a base 400 having a rigid body without a port and a base 410 that includes a port 402.

[0040] Returning to FIG. 3, in a non-compressed state, the body 306 may have, for example, but not limited to, a cylindrical shape, hexagonal shape, or other like tubular shape. The body 306 may be configured to store a fluid and allow a fluid to pass through the body 306, as described herein. As the body 306 compresses, base 302 and / or base 304 may move towards oneanother as the volume of the interior of the body 306 compresses. The body 306 may be formed from, for example, but not limited to, a plastic film or polyester film (i.e., a polyethylene terephthalate (PET) film), such as a metalized Biaxially oriented PET (BoPET), and like film. The body 306 may be transparent or semi-transparent to allow a user to see the contents within the cartridge 300. In some cases, the body 306 may be corrugated (e.g., such as the corrugated body 806 of cartridge 800 illustrated in FIGs 8A-8C). The ridges and grooves of the corrugated body 306 may extend in a parallel direction with the base 302 and base 304. The corrugated sections of the body 306 may facilitate the compression of the body 306. For example, as the volume of the interior of the body 306 compresses, the body 306 may compress at the corrugated areas of the body 306, thereby directing the base 302 and / or base 304 to move towards one another.

[0041] In one or more cases, the surface of the body 306 may be color coded and / or marked with text or another indicator, such as, but not limited to, a bar code, a quick response (QR) code 320c, and the like to provide information corresponding to the contents of the cartridge 300. For example, the surface of the body 306 may include a drug name 320a, a dosage 320b, a volume 320d, a product and lot number (not shown), expiration date (not shown), and the like. The one or more indicators allow a user, such as a physician, to visually verify a drug that is being administered, via the cartridge 300. As such, the indicators allow physicians to comply with regulations such as UCLA policies AMB 130 and AMB 143, which states “in every instance, prior to administration of medicine by a medical assistant, a licensed physician or podiatrist, or another appropriately licensed person shall verify the correct medication and dosage.”

[0042] The bar code and / or QR code 320c included on the cartridge 300 may contain a link to a product website corresponding to the drug contained within the cartridge 300. The productwebsite may include further information such as drug and ordering information. The bar code and / or QR code 320c allows the cartridge 300 to be scanned along with a dispenser and / or patient wristband to confirm the medication, time of administration, and dose of the medication that is injected. In some cases, the scanned information is automatically entered into the patient’s digital record. As such, medical staff may save time when recording the administration of the medication and assure the accuracy of the record. In some cases, a system may compare the scanned medication information against a prescriber’s orders to determine whether the correct medication is being administered, whether there is a risk of medical reaction based on the combination of medication being administered, and / or whether the patient has a history of allergic reactions to the medication being administered, thereby eliminating or reducing medical errors.

[0043] In one or more cases, the body 306 of the cartridge 300 may be tinted a specific color corresponding to one or more features of the cartridge 300. For example, the tinted color of the body 306 may indicate one or more types of fluid contained within the cartridge 300. For instance, one color may indicate that the cartridge 300 includes saline, another color may indicate that the cartridge 300 includes a first drug, and another color may indicate that the cartridge 300 includes a second drug. In another example, the tinted color of the body 306 may indicate the order of the cartridge 300 positioned within the cartridge stack 106. For instance, one color may indicate that the cartridge 300 is a flush-type cartridge that should be positioned at the end of the cartridge stack. In another instance, another color may indicate that the cartridge 300 includes a specific type of port to attach to, for example, a Luer lock.

[0044] Base 302 may be a rigid body the defines an outer end of the cartridge 300 and base304 may be a rigid body that defines another outer end of the cartridge 300. Base 302 and 304may be formed from a rigid plastic or other like material that can maintain the shape of the respective base while withstanding fluid pressure. Base 302 and base 304 may each include a port, such as port 308 and port 310, respectively, configured to retain a fluid within the cartridge 300 and to allow a fluid to pass through and / or exit the cartridge 300.

[0045] In one or more cases, the port includes a valve that is configured to control a direction of fluid flow. The valve of a port may be actuated from a closed position to an open position based on fluid pressure directed onto the port. For example, when the valve 316 of port 308 is configured in an open position, the port 308 may be configured to allow fluid to flow in direction Fi into the body 306 of the cartridge 300. In another example, when the valve 312 of port 310 is configured in an open position, the port 310 may be configured to allow fluid to flow in direction Fo out of the body 306 of the cartridge 300. In another example, when the valves 312 and 316 of ports 308 and 310 are configured in a closed position, the ports 308 and 310 are configured to contain fluid within the body 306 of the cartridge 300. In some cases, the valve may include a glued membrane that breaks open under pressure, thereby allowing fluid to flow through the port. In other cases, a port may include a spring mechanism that actuates under pressure to position the respective valve from a closed position into an open position.

[0046] In one or more cases, the body of one port may protrude away from the outer surface of the respective base, such that the port resides outside of the inner cavity defined by the body 306, base 302, and base 304. For example, the body 314 of the port 310 may extend outwards from the outer surface 305 of the base 304. The body 314 of the port 310 may be, for example, but not limited to, cylindrically shaped, conically shaped, shaped as a cuboid, shaped as a cube, shaped as a hexagonal prism, and the like. In one or more cases, the body of another port may protrude from the base and into the inner cavity of the body 306, such that the port resides withinthe body 306. For example, the body 318 of port 308 may extend from the base 302 and into the inner cavity of the body 306. In one or more other cases, a portion of the body of the port or the entirety of the body of the port resides within the base of the cartridge. For example, as illustrated in FIG. 5A, port 511 of cartridge 202b resides within the base 512 of cartridge 202b.

[0047] In one or more cases, the body of the port may define a cavity sized to receive a port of another cartridge, such that the port of the other cartridge resides snuggly within the body of the port. That is, the cavity of the body 318 may be sized and shaped to receive a port of another cartridge therein. For example, as illustrated in FIG. 4, the body 402 of port 404 defines a cavity 403 within the port 404 that is sized to receive a port 405 of cartridge 202c therein.

[0048] FIG. 4 illustrates an example series of cartridges that form the cartridge stack 106. In one or more cases, the cartridge stack 106 may include any number of cartridges. For example, as illustrated in FIG. 4, the cartridge stack 106 includes three cartridges, such as cartridge 202a, cartridge 202b, and cartridge 202c. In some cases, a maximum number of cartridges within the cartridge stack 106 may correspond to a size of the barrel 208 of the barrel assembly 104 and an area of the plunger seal 110 to fit within the barrel 208 in a loaded position, as illustrated in FIGs. 1 and 5 A. In one or more cases, each cartridge within the cartridge stack 106 is configured to hold the same volume of fluid. In one or more other cases, the cartridges within the cartridge stack 106 may be sized to hold different volumes of fluid. For example, one cartridge may be sized to hold 5 mL of one medicament, and another cartridge may be sized to hold 7 mL of medicament.

[0049] A cartridge, such as cartridge 202a, at the front of the cartridge stack 106 includes a port, such as port 204, that is configured to couple to a dispensing device, such as, but not limitedto, a Luer Lock connector, a disposable safety needle, and the like. The front cartridge may be the first cartridge inserted into a barrel of an injection apparatus.

[0050] The cartridge, such as cartridge 202c, that is positioned at the rear of the cartridge stack 106 may be a flush cartridge. The flush cartridge may include one or more of the features of cartridge 300. The flush cartridge is distinguishable from other cartridges within the cartridge stack 106 in that the base 400 of flush cartridge does not include a port. Rather, the base 400 may be a rigid body that defines the outer end of the cartridge 202c and is configured to interface with a portion of the plunger 108, such as the plunger seal 110. The base 400 may be rigid enough to withstand the force of the plunger 108 being depressed within the barrel 208 of the apparatus 100 while forcing fluid within the cartridge stack 106 to the front of the cartridge stack 106. The flush cartridge may contain a saline or heparin flush to ensure that the entire contents of the remaining cartridges within the cartridge stack 106 are flushed out of the cartridge stack 106 when the plunger 108 is depressed within a barrel of the injection apparatus. The flush cartridge may be used to ensure that all fluid pressure is forced toward the front of the cartridge stack 106 and the injection apparatus. Further, the flush cartridge may be used to ensure that no fluid can escape backwards towards the rear of the apparatus 100. In one or more cases, the flush cartridge may include the smallest volume of fluid necessary to effectively flush the cartridge stack 106 while maintaining optimum performance. That is, the end flush ensures that all of the medicaments in the downstream cartridges are administered. It is noted that the examples described herein relate to the cartridge, such as cartridge 202c, containing a saline or heparin flush. However, it should be understood that the cartridge 202c may contain a medicament, for example, but not limited to, cases in which a flush operation is not allowable, such as in an intraarticular injection.

[0051] It is noted that the examples described herein relate to a cartridge stack that includes multiple cartridges. However, it should be understood that embodiments are contemplated herein in which an injection apparatus, such as the apparatus 100, uses only one cartridge. In such cases, the individual cartridge may include one or more of the same or similar features as the flush cartridge, and a description of those features is not repeated. Moreover, the individual cartridge may include an individual medicament or a mixture of medicaments.

[0052] In one or more cases, the cartridges are pre-loaded with a dosage of a medicament from a drug manufacturer. In such cases, the cartridges may be marked with text or other indicators, such as a QR code, as described herein to provide information corresponding to the contents of the respective cartridge. The pre-loaded cartridges may improve safety and sterility, in addition to ensuring traceability of the fluid within the cartridge. In one or more other cases, a licensed pharmacist or a medical assistant (MA) may load an empty cartridge using a loading apparatus. The loading apparatus may be configured to inject the appropriate volume of medicament within the cartridge and seal the cartridge such that the contents of the cartridge are sterile. The cartridges, whether loaded by a manufacturer or in-house, such as by licensed pharmacist or MA, may be sealed in a plastic wrapper to maintain sterility of the port until use.

[0053] To assemble the cartridge stack 106, each cartridge within the cartridge stack 106 locks into the adjacent cartridge within the cartridge stack 106. Adjacent cartridges may be locked into one another via the ports of the respective cartridges. For example, a port of one cartridge, such as port 405 of cartridge 202c is inserted into a port of another cartridge, such as port 402 of cartridge 202b.

[0054] The ports 402 and 405 may be configured to lock to one another, thereby coupling the cartridge 202c and cartridge 202b to one another. When coupled together, the locked ports forma sterile watertight seal. As such, when fluid passes through the cartridges, via the locked ports, and exits a delivery assembly, the fluid does not enter or leak into the body of the injection apparatus. In some cases, the ports 402 and 405 may lock with one another via a twist and lock mechanism. For example, one of the ports 402 and 405 may include one or more detents and the other of ports 402 and 405 may include one or more ramps for receiving the detents. The port 405 may be inserted into the port 402, such that the one or more detents are inserted into the one or more ramps. One or both of the ports 402 and 405 may be rotated allowing the detents to move within their respective ramps to a locked position. In some other cases, the ports 402 and 405 may lock with one another via a screw fit. For example, one of ports 402 and 405 may include a male threaded end and the other of ports 402 and 405 may include a female threaded end sized to receive the male threaded end. The port having the male threaded end may be inserted into the port having a female threaded end by rotating one or both ports until the ports are threaded onto one another. In some other cases, the ports 402 and 405 fastened together via a pressed fit after the ports 402 and 405 are pushed together.

[0055] It is noted that although the examples described herein relate to coupling ports 402 and 405, it should be understood that the examples may apply to any of the ports within the cartridge stack 106, such as ports 406 and 408 of cartridges 202b and 202a. Further, in one or more cases, although the ports are coupled to one another, the valves of each port may remain in a closed position until the valves are actuated into an open position based on fluid pressure directed onto the valve from an upstream cartridge. That is, the ports may remain sealed, and the contents of the cartridges may remain within the respective cartridges and unmixed until a plunger of the syringe is depressed creating fluid pressure that actuates the valves of the cartridge stack 106.

[0056] FIG. 5A is a side view of an example compound injection apparatus 500 (hereinafter“apparatus 500”) configured in a loaded position. FIG. 5B is a side view of the apparatus 500 configured in a dispensed position. The apparatus 500 is illustrated as a conventional syringe that includes a plunger 508, a plunger seal 502, a barrel 504, a hub 510, and a needle 506. Although illustrated with the needle 506 coupled to the hub 510, it should be understood that the apparatus 500 may alternatively be coupled to a Luer lock connector of IV tubing, via a Luer lock tip attached to the hub 510 and / or port 204 of the cartridge stack 106. Further, it is noted that although the process of loading and dispensing fluid of the cartridge stack 106 is described with respect to the apparatus 500, it should be understood that the process of loading and dispensing the fluid of the cartridge stack 106 may be equally applied to the apparatus 100. As such, a description of such process utilizing the cartridge stack 106 with apparatus 100 is not repeated.

[0057] In one or more cases, having loaded and locked the cartridges, such as cartridges 202a, 202b, and 202c, together to form the cartridge stack 106, a user inserts the cartridge stack 106 into the plunger end 516 of the barrel 504 of the apparatus 500. Further, the user may insert the plunger seal 502 of the plunger 508 into the barrel 504. The plunger seal 502 may be pressed against the rear end 206 of the cartridge stack 106 until the insertion end 418 of the cartridge stack 106 interfaces with the inside of the dispensing end 518 of the barrel 504. When loaded into the barrel 504, the port 504 of the front cartridge 202a protrudes outside of the dispensing end 518 of the barrel 504. The user may fasten the hub 510 to the protruded portion of the port 204 such that the dispensing end 518 of the barrel 504 is sandwiched between the insertion end 418 of the cartridge stack 106 and the hub 510. As such, the cartridge stack 106 may be locked together with the barrel 504 of the apparatus 500.

[0058] The hub 510 may be a disposable coupling member that is configured to couple to a port of a cartridge in a same or similar manner as a port of one cartridge being coupled to a port of another cartridge. For example, the hub 510 may be configured to couple with the port 204 via one of a twist and lock mechanism, a screw fit, or a pressed fit. In one or more cases, the hub 510 may include a filter to collect any debris that passes from the cartridge stack 106 and / or barrel 504 to the needle 506. The needle 506 may be coupled to the hub 506.

[0059] In one or more cases, a safety needle cap 600, as illustrated in FIG. 6, may be positioned over the needle 506. The needle cap 600 may include a coupling member 602 and a protective cap 604. The coupling member 602 may be configured to snap onto the hub 510. The protective cap 604 may be configured to translate along the needle 506 as the user presses against a rotatable arm 606. When the protective cap 604 reaches the tip 608 of the needle 506, the protective cap 604 slides over the tip 608 of the needle 506.

[0060] Returning to FIG. 5B, in one or more cases, having configured the apparatus 500 in the loaded position, a user may insert the needle 506 into, for example, a body of a patient. The user may depress the plunger 508 in the direction DI. As the plunger 508 is depressed in the barrel 504 and against the cartridge stack 106, the cartridges 202a, 202b, and 202c begin to compact. The fluid pressure of the compacted cartridges actuates the valves of the ports into an open position. As the valves are opening and being configured in the open position, the fluid contained within the cartridges begins to mix. The fluid pressure forces the fluid within the cartridges to move downstream through the hub 510 and exit the needle in direction D2 (e.g., into the body of the patient). The hub 510 may filter the fluid that passes through the hub 510. The cartridge 202c may be the flush cartridge that flushes the fluids within the downstream cartridges out of the apparatus 500. As such, the cartridge 202c is used, for example, to ensurethat all the medicament stored within the downstream cartridges are delivered into the body of the patient. Upon completion of the injection, a user may slide the protective cap 604 over the tip 608 of the needle 506 and dispose of the entire apparatus 500.

[0061] FIG. 7A is a perspective view of an example image scanning apparatus 700. FIG. 7B is a perspective view of the image scanning apparatus 700 coupled to the apparatus 500.

[0062] In one or more cases, the image scanning apparatus 700 may include one or more cameras positioned on a front surface 710 of the image scanning apparatus 700, and a coupling member 704 attached to the rear surface 712 of the image scanning apparatus 700. The coupling member 704 may include flexible arms 706 and 708 configured to couple the image scanning apparatus 700 to one or more portions of apparatus 100 or apparatus 500. For example, the flexible arms 706 and 708 may be configured to snap onto the barrel 504 of the apparatus 500, such that the one or more cameras 702 face the barrel 504, as illustrated in FIG. 7B.

[0063] The image scanning apparatus 700 may be configured to capture images of one or more indicators or text provided on a cartridge that corresponds to the contents or other features of the respective cartridge. The image scanning apparatus 700 may be configured to convert the captured images into digital information and provide the digital information to a computer for further processing and analysis. For example, the image scanning apparatus 700 may be configured to capture images of a bar code and / or a QR code, such as QR codes 714a, 714b, and 714c provided on the surfaces of cartridges 202c, 202b, and 202a, respectively. Additionally or alternatively, the image scanning apparatus 700 may be configured to capture images of text such as a drug name, dosage, volume of fluid within the cartridge, a product and lot number, an expiration date, and the like.

[0064] The image scanning apparatus 700 may be configured to perform image processing techniques, such as optical character recognition processes or QR image recognition processes, to convert the captured image into digital information. The digital information may be provided to an application that records the fluids of the cartridge stack 106 that was administered via the apparatus 500. In one or more cases, the digital information (i.e., the fluids and information associated with the cartridges) may be associated with digital information associated with the patient who received the injection. For instance, digital information associated with the cartridges may be uniquely linked to digital information associated with a patient’s wristband or chart in addition to or in the alternative to the individual who filled the cartridges and / or the individual who administered and / or prescribed the injection.

[0065] In one or more cases, during the loading process, the user may attach the image scanning apparatus 700 to the barrel 504 of the apparatus 500. The user may align the text or other indicators, such as QR codes 714a, 714b, and 714c, of the cartridge stack 106 with the field of view of the one or more cameras 702 of the image scanning apparatus 700. As the cartridge stack 106 is inserted into the barrel 504 in the direction D3, the cameras 702 capture images, for example, of the QR codes 714a, 714b, and 714c. The image scanning apparatus 700 converts and records the digital information of the captured images to be associated with the patient receiving the injection and the patient’s medical records. After the medication is dispensed, the image scanning apparatus 700 is removed from the apparatus 500, and the apparatus 500 is disposed. It is noted that although the image scanning apparatus 700 is described as being an attachable image scanning apparatus 700, it should be understood that the image scanning apparatus 700 may be a stand-alone device allowing the user to scan the cartridge stack 106 without having the image scanning apparatus 700 interfere during the injection. Additionally, a stand-alone imagescanning apparatus allows the cartridges to be scanned before being assembled into the cartridge stack 106 or before the cartridge stack 106 is loaded into the apparatus 500.

[0066] FIG. 8 is a perspective view of an example cartridge 800. The cartridge 800 includes the same or similar features as cartridge 300 of FIG. 3. For example, cartridge 800 includes a compressible body 806 disposed between a base 802 and a base 804, similar to that of cartridge 300. Further, the cartridge 800 includes ports, such as ports 808 and 810 disposed on each of base 802 and 804, similar to that of cartridge 300. As such, a description of these same or similar features is not repeated. Cartridge 800 is distinguishable from cartridge 300 in that the cartridge 800 is formed from a cap 810 and a capsule 803.

[0067] Capsule 803 may include the body 806 disposed between base 802 and a rigid body805. The body 818 of port 808 may include a receiving end 817 and a neck 819. In some cases, the receiving end 817 may be a luer lock that is sized to receive and couple with a luer lock connector. Additionally or alternatively, the receiving end 817 may be sized to receive a port of another cartridge. In one or more cases, at least a portion of the neck 819 resides within the body806. The portion 821 of the body 806 that surrounds the neck 819 may be sealed off from the remaining portion 823 of the body 806 such that liquid is prevented from collecting around the portion 821 of the body 806 that surrounds the neck 819. In one or more cases, the surface of the base 802 be color coded and / or marked with text or another indicator, such as, but not limited to, a bar code, a QR code, and the like to provide information corresponding to the contents of the cartridge 800.

[0068] The rigid body 805 of the capsule 803 defines an outer end of the compressible body 806 and is rigid enough to maintain the outer shape of the body 806. The body 805 may be formed from a rigid plastic or other like material. The body 805 is sized to receive a portion ofthe cap 810 therein to form the base 804. For example, the cap 810 includes a body 815 having a neck 824 that protrudes from one side of the body 815 and a body 814 of the port 810 protruding from an opposite side of the body 815. The neck 824 may have a diameter that is smaller than the diameter of the body 815 and is sized to fit within at least a portion of the body 805. When the cap 810 is coupled to the capsule 803, the body 815 of the cap 810 and the body 805 of the capsule 803 interface with one another to form the base 804.

[0069] In one or more cases, one or both of the cap 810 and capsule 803 are formed via, for example, three-dimensional (3D) printing, blow molding, other like methods, or a combination thereof. In some cases, the cap 810 and capsule 803 are permanently coupled to one another, such that the cap 810 cannot be removed from the capsule 803. The cap 810 and capsule 803 may be permanently coupled to one another via a bonding process, such as being glued or fused to one another. In other cases, the cap 810 and capsule 803 are removably coupled to one another, such that the cap 810 and capsule 803 may be separated from one another. For example, the cap 810 and capsule 803 may be separated from one another to clean the interior of the body 806 and to refill the cartridge 800 for subsequent use. In some cases, the cap 810 and capsule 803 are coupled to one another via, for example, a press fit, such that the cap 810 and capsule 803 may be separated from one another.

[0070] The various embodiments described above are provided by way of illustration only and should not be construed to limit the claims attached hereto. Those skilled in the art will readily recognize various modifications and changes that may be made without following the example embodiments and applications illustrated and described herein, and without departing from the spirit and scope of the following claims.

Claims

CLAIMSWhat is claimed is:

1. A compound injection apparatus, comprising: a syringe comprising a barrel, a hub mounted to an end of the barrel, a plunger slidably mounted in the barrel; and a first cartridge and a second cartridge operably connected to one another within the barrel of the syringe, the plunger being configured to actuate the first and second cartridges by compressing the first and second cartridges from a first position to a second position, wherein, in the first position, a first fluid is contained within the first cartridge and a second fluid is contained within the second cartridge, and wherein, in the second position, at least a portion of the first fluid and at least a portion of the second fluid mix and are dispensed from the syringe.

2. The compound injection apparatus of claim 1, wherein the first cartridge and second cartridge are comprised of a film.

3. The compound injection apparatus of claim 1, wherein the first cartridge and second cartridge are operably connected to one another via ports coupled to one another.

4. The compound injection apparatus of claim 3, wherein in the first position, the ports are configured in a closed position such that the first fluid is contained within the first cartridge and the second fluid is contained within the second cartridge.

5. The compound injection apparatus of claim 3, wherein in the second position, the ports are actuated into an open position such that the one or both of the first fluid and second fluid pass through the ports.

6. The compound injection apparatus of claim 3, wherein the ports are locked to one another forming a watertight seal, the ports being locked to one another via one of a twist and lock mechanism, a press fit, or a screw fit.

7. The compound injection apparatus of claim 1, wherein the first cartridge comprises a compressible body disposed between a rigid first end configured to interface with the plunger and a rigid second end comprising a port operably connected to a port of the second cartridge.

8. The compound injection apparatus of claim 7, wherein the first fluid of the first cartridge comprises a flush solution or a first medicament and the second fluid of the second cartridge comprises a second medicament.

9. The compound injection apparatus of claim 7, wherein the first cartridge is configured to direct a flow of fluid towards the hub of the syringe.

10. The compound injection apparatus of claim 1 , wherein the second cartridge comprises a compressible body disposed between a rigid first end comprising a first port operably connected to a port of the first cartridge and a rigid second end comprising a second port operably connected to a port of a third cartridge or the hub of the syringe.

11. The compound injection apparatus of claim 1, wherein a body of the first cartridge comprises an indicator corresponding to the first fluid contained within the first cartridge.

12. The compound injection apparatus of claim 1, further comprising an image scanning apparatus coupled to the barrel of the syringe, wherein the image scanning apparatus is configured to capture one or more images of one or more indicators disposed on the first and second cartridges.

13. A fluid compounding system, comprising: a first cartridge comprising a compressible body disposed between a rigid first end and a rigid second end comprising a first port; and a second cartridge comprising a compressible body disposed between a rigid third end comprising a second port and a rigid fourth end comprising a third port, wherein the second port of the second cartridge is operably connected to the first port of the first cartridge, wherein, in a first position, the first port and the second port are sealed such that a first fluid is contained within the first cartridge and a second fluid is contained within the second cartridge, and wherein, in a second position, the first port and the second port are open such that one or both of the first fluid and second fluid pass through the first and second ports.

14. The fluid compounding system of claim 13, wherein the rigid second end of the first cartridge comprises a cap that is coupled to a rigid proximal end of the compressible body of the first cartridge, and wherein at least a portion of the cap is positioned within the proximal end when the cap and compressible body of the first cartridge are coupled to one another.

15. The fluid compounding system of claim 13, wherein the first port and the second port are locked to one another forming a watertight seal, and wherein the first port and the second port are locked to one another via one of a twist and lock mechanism, a press fit, or a screw fit.

16. The fluid compounding system of claim 13, wherein the first fluid of the first cartridge comprises a flush solution or a first medicament and the second fluid of the second cartridge comprises a second medicament.

17. The fluid compounding system of claim 13, wherein the body of the first cartridge comprises an indicator corresponding to the first fluid contained within the first cartridge.

18. The fluid compounding system of claim 13, wherein the fluid compounding system is sized to fit within a barrel of a syringe that is configured to actuate the fluid compounding system from the first position to the second position.

19. The fluid compounding system of claim 18, wherein the rigid first end of the first cartridge is configured to interface with a plunger of the syringe.

20. The fluid compounding system of claim 18, wherein the third port of the second cartridge is operably coupled with a hub of the syringe.

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