BACKGROUND

Administering a medical injection is often a high-stress emotional process which presents a number of risks and challenges for both patients (human and non-human) and healthcare professionals. These stresses may be both mental and physical, and result in part from the design and method of operation of the injector and the container in which the medicament is delivered from the manufacturer.

Injection devices (i.e., devices capable of delivering medicaments from a medication container such as a glass vial) typically fall into two categories -manually operated devices and auto-injectors, and have typically been axial in actuation force and injection insertion direction. In a manual device the user must provide the mechanical energy to drive the fluid through the needle. This is typically done by some form of piston having a bearing surface (button) that is continuously pressed by the user during the injection.

Fundamentally, common axial barrel/plunger syringes have been in service since the late 1800’s and have remain unchanged. The actuation of the plunger is distal and in the direction of insertion of the injection needle. In this disclosure we propose significant value in the actuation force not being axial to the needle insertion direction, and proximal to the injection needle, thus allowing for better needle insertion control, better injection pressure control, one hand application, less stress more intuitive operation.

Axial syringes are awkward to handle and difficult to administer with a drawn plunger being inconvenient for an administrator/user to reach and actuate, especially when the piston is fully withdrawn after filling the syringe. The combination of injection force and button arrangement, arm wrist motor function can cause trembling/shaking of the hand which in turn increases discomfort and causes tissue damage to the patient as the inserted needle moves. Actuation of the injection device axial to the direction of the injection force is problematic in both hypodermic injectors and nasal drug delivery devices.

Preparation of medicaments and administration to an individual often involves mixing of two or more components and subsequent delivery of the mixture to the individual. The mixing of components can typically involve extraction of one component in fluid form from a vial or other container and transfer of such components into a separate container which holds another component. In particular instances, only a portion of the contents of a vial or container is used for preparing the mixture prior to administering. Accordingly, the extraction and transfer may involve precise measuring of one or more components to be mixed.

Additionally, incomplete extraction or improper measurement of one or more components can result in preparation and/or administration of an improper dosage. In some instances, after a medicament is mixed, the final mixture must again be extracted from a vial or container into a syringe prior to administering to an individual. Such additional transfer can lead to additional opportunities for contamination, incomplete extraction of contents and/or inaccurate measuring of a component or the resulting medicament. In practice, there is limited availability of sterile environments for maintaining sterility during transfer and/or mixing of components, or preparation and transfer of medicaments. Additional errors can result from use of the wrong diluent to reconstitute the medication, transferring/recording medication data and validation of expiration. Finally, preparation of medicaments utilizing multiple components can be tedious and time consuming and stressful due to factors such as the need to access individually packaged items such as separate vials and/or transfer devices when attempting to comply with guidance from health agencies. In the anticipation of a necessary world-wide vaccine, the production speed, administrator and user safety concerns, high volume demand and low-cost delivery along with a human administration error reduction all have to be considered for a vaccine’s high success rate.

It is desirable to move towards self-administration devices for a world-wide vaccine however production issues, expiration of medicament in pre-filled and high cost auto injectors, along with critical temperature storage requirements for many vaccines continue to deter large scale use of these systems.

It is apparent that there is a longstanding and unmet need for an injector that features non- axial actuation proximal to the injection site, since such an injector provides better control of insertion, and better control of injection, minimizing risk and damage to tissue. There is also a need for an injector that withdraws medicament from a delivery container such as a glass vial and delivers a measured dose injection without the need for an operator to manually withdraw the proper dose or to visually confirm the volume prior to injection. There is also a need for an injector that simplifies mixing of several components in a sterile environment without the need for the operator to manually transfer each component while visually confirming the volume of one or more prior to mixing, or to transfer the final mixture from a mixing vessel to a syringe prior to injection. Finally, there is a need to provide improved safety for the operator of an injection apparatus to reduce the probability of needle-stick injury to the operator, and of tissue damage to the patient due to unintended movement of the needle after insertion.

The prior art has recognized the need for better injection systems for medicaments, and has responded with relevant innovations including, but not limited to US Patent Nos. 10,478,560; 10,737,019; 10,702,661; 9,861,555; 10,716,897; and 10,426,703. Each of these inventions lacks the combination of elements important to the success of the present invention. BRIEF DESCRIPTION OF THE INVENTION

The present invention expands new concepts in basic syringe packages. The first being an improvement to integrate the common medicament delivery vial, with a reorientation of manual actuation for superior handling and control, calibrated dosing, device arming and multiple power options. The second improves upon that syringe by adding in a secondary chamber and valved core which provides for medicament preparation process for reconstituted medicaments while minimizing human error. Third is the introduction of a retracting safety needle and one-use feature to better protect medical workers and the drug using population. The core is spring loaded and becomes armed when a needle cover is removed just prior to injection. Upon complete discharge of calibrated dose, the core/needle combination retracts from the face of syringe back into the housing and locks. The fourth embodiment includes an auto-inject option where the needle cover, once armed, collapses into the outer syringe housing when depressed onto the patient. Optionally, the outer surface of the needle cover and/or syringe housing may be treated with an anesthetic, or provided with a means to deliver an electric current or mechanical vibration as a means to desensitize the injection area prior to injection.

The integration of existing non modified glass vials (or other containers) allows for continuity in practice of medicament delivery methods and proper storage (material and temperature) with reduction in deployment risk and faster administration. Lateral actuation, precision one hand grip and an auto retracting safety needle simply provides better patient care and healthcare worker safety. When presented with auto-injector configuration, the ability to simply replace the expired medicament would provide flexibility to patients whereas updated unexpired vials could be regularly delivered in anticipation of emergency needs at a much lower cost than the present practice of replacing the entire injector upon expiration of the medicament. The invention comprises a manually actuated syringe device accommodating a luer lock hypodermic needle, and comprising a single button with spring return, or dual button actuator (for loading on the one hand, and for injection on the other) having an axis of actuation substantially normal to the axis of the hypodermic needle. The axis of actuation being normal to the axis of the needle aids in bubble management, because bubbles may be isolated. The invention optionally includes a way to visually inspect actuator position during application.

An improved embodiment comprises medicament vial integration with a secondary vial needle to reduce syringe labeling/tracking of medicament delivery. The basic aspect the invention encompasses a non-linear manual syringe device with medicament vial integration needle. The device includes a syringe body having a generally cylindrical housing and a lateral non axial chamber within the housing, and manually actuated plunger with elastomeric seal. A needle cover operably arms the device when ready to administer medicine delivery.

For medicament preparation (reconstitution) process improvement the device incorporates a fluid passageway extending through the core connecting the glass vial to a lateral chamber. The lateral chamber and core are designed to better manage bubbles and air that are introduced in the mixing process. The core is operably a valve with two ported options associated with the fluid passageway which direct flow from chamber to vial and chamber to patient needle. A needle cover protects user/administrator from the injection needle and when removed arms the auto retraction core and sets core valve position for delivery to the injection needle.

In one implementation of the invention an operable core consists of two specific needles, one to pierce the medicament vial and the other for patient injection, although other vial piercing methods could be introduced to provide access to medicament beyond the vial seal. It would be anticipated to not damage the seal in cases where a multi dose vial is desired. Throughout the reconstitution process the Patient needle remains covered (sterile), when the needle cover is removed and device is armed for vaccine or medicament delivery.

In another aspect the invention encompasses a method of preparing (reconstituting) a medication agent for administration to an individual. The method includes providing a first vial with a first component and a second component provided within a second vial. A valve is associated with a fluid passageway between the vial and the non-axial syringe chamber whereas fluid can move freely with actuation of chamber plunger or pump. The first and second components are mixed to produce the medication agent. Mixing can be facilitated by agitating, inverting and swirling the device and/or repeated actuation of the piston/chamber. The integrated vial provides visual observation of proper reconstitution.

In general, the invention includes a housing capable of receiving a medicament vial, a two- needle core with associated valve porting and lateral chamber with elastomer plunger seal. In alternative applications, manual or powered nonlinear rotary or reciprocating pumps are used to propel fluid medicament to and from chamber to core needles and vials.

In sum, the present invention is an injection apparatus for manually injecting medicament into a patient. The injection apparatus uses two hollow needles - a patient needle to inject the medicament into the patient and a separate loading needle to load the medicament into the injection apparatus. The pointed end of the loading needle penetrates the cap of a medicament vial for loading the medicament. The body of the injection apparatus supports the medicament vial during the loading process. The other end of the loading needle is in fluid communication with a lateral chamber within the body of the injection apparatus. A manual finger-operated pump, with a direction of actuation normal to the longitudinal axis of the patient needle, is configured to pump air to pressurize the lateral chamber. The user manipulates the finger-operated pump to pressurize the lateral chamber and the lateral chamber pressurizes the medicament vial through the loading needle. When the user releases the finger-operated pump the air pressure in the lateral chamber drops and the increased air pressure in the vial forces the medicament through the loading needle and into the lateral chamber. Both the patient needle and loading needle are attached to a replaceable core, which may be changed for each injection. The replaceable core includes valves to select fluid flow between the medicament vial and the lateral chamber, and alternatively to select flow from the lateral chamber to the patient needle. In preparation for injecting the medicament into the patient, the user will select the valve setting that directs the medicament from the lateral chamber and to the patient needle.

The patient needle is oriented in a direction opposite to the loading needle and is covered by the body of the injection apparatus and/or by a safety cover until just prior the moment of injection. Upon activation of the injection apparatus by a patient using the autoinjection embodiment, a spring is released and propels the patient needle forward until the patient needle penetrates the patient, as required by the particular medicament. A safety in the form of a patient needle cover prevents premature activation of the patient needle. Once the needle cover is removed, the patient needle is armed and the spring is ready to propel the patient needle. The user then activates the finger-operated pump to pressurize the lateral chamber and to push the medicament through the patient needle and into the patient. Once the medicament is injected by full depression of the pump piston, the patient needle retracts under spring force into the body of the injection apparatus. Alternatively, a sleeve surrounding the needle may be released to retract upon actuation. As another embodiment, actuation may be by electrical or pneumatic means, with or without a spring.

BRIEF DESCRIPTION OF FIGURES

Fig 1 A - Syringe enclosure main housing

Fig IB - Dual needle core valve

Fig 1C - Dispense and load actuators with integral piston Fig 2A - Syringe enclosure with integrated vial

Fig 2B - Rotary pump syringe example Fig 2C - Pneumatic syringe example

Fig 3 A - Fluid passageway chamber to vial

Fig 3B - Fluid passageway chamber to injection needle

Fig. 3C - Armed non-axial safety syringe pre-injection position

Fig. 4A- Non-axial safety syringe post-injection arrangement Fig. 4B - Lateral non-axial fluid chamber

Fig. 4C - Non-axial safety syringe with needle post injection position section view

Fig. 5 A - Perspective view of a “mini” version of an injector of the present invention.

Fig. 5B - Section view of the injector of Fig. 5 A

Fig. 5C - Plan view showing section locations of Figs. 5B and 5D. Fig. 5D - Section view of the injector of Fig. 5 A

Fig. 5E - Section view of plane shown in Fig. 5F.

Fig. 5F - Plan view showing location of section view in Fig. 5E. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The invention disclosed may comprise a syringe enclosure inclusive of a syringe chamber, a valve needle core, vial needle, injection needle, fluid porting and fluid passageway, core retaining element, piston button with piston chamber seal, spring return cavities, retraction spring, core control raceway and locking needle cover. The syringe enclosure further comprises operable core alignment guides, needle cover locking provisions, and a core vial clip expansion void to allow insertion and removal while in locked position. An associated dispense and load button with integral piston coupled to button springs to auto return to open chamber state.

Syringe housing which includes the secondary chamber and piston seal can be manufactured for a particular application in accordance with the invention. The chamber, needle core and piston seal can be fabricated to comprise for example medical grade/approved glass or plastic material(s). Materials which can be utilized for medicament contacting component formation include but are not limited to polyethylenes, polypropylenes, polycycloolefms, polyvinyl chloride (PVC), polyamides (including aliphatic and aromatic variants), polyesters, polycarbonates, copolymer materials including but not limited to those containing ethylene- diene-propylene monomer (EPDM), polyacrylates, polyurethanes, composites, blends or combinations of such materials, or alternative composite materials.

The volume of the syringe chamber is not limited to a particular value and the syringe body may be configured to contain a maximum volume of, for example, from .5 ml to greater than 1.5 ml. Preferably, the syringe chamber volume will be calibrated and designed for specific dose applications. Alternatively, multiple smaller chambers may be used to increase the vacuum efficiency, yet maintaining the draw length.

Where the piston seal is formed as an independent structure relative to the syringe chamber and dispense piston, the plunger or piston seal may preferably comprise a relatively soft elastomeric material. Materials which can be appropriate for fabrication of the piston seal and core seal based upon manufacturability, biocompatibility and/or chemical compatibility, and ability to produce a fluid seal include elastomeric materials such as rubber, butyl, silicones, silanes, polypropylene, polypropylene-EPDM, polyurethanes, and other appropriate plastics, as well as various copolymers, blends and combinations thereof.

The present invention teaches a non-linear, a non-axial approach to a medical delivery device with the accommodation of a medical delivery vial to the following: syringe device, mixing syringe, safety syringe with auto retraction of needle, and auto-injector solutions. Additionally, the present invention teaches a methodology for combining and mixing to produce a mixture and encompasses device configurations to allow combination and mixing of components. In particular, the methodology of the invention involves combining and mixing components to produce an administration-ready agent such as a medicament and, in particular aspects, includes administering such agent to an individual. Accordingly, device configurations of the invention allow combination of separate components such that the combined and mixed components are ready for administration. In particular aspects the encompassed devices are additionally configured for use during administration of the administration-ready agent.

In the present non-linear approach multiple pump methods are considered, reciprocating (barrel/piston) and rotary or screw. A lateral reciprocating chamber offers some additional benefit of better bubble and air management because air bubbles float to the top of the lateral chamber and are not driven through the lower injection needle port. Additional embodiments are disclosed wherein rotary pumps are used to eliminate the syringe chamber, drawing fluid directly from a vial and driving fluid directly to the injection needle. Rotary and screw pump syringes would have the added value of incremental metering the controlled dose delivery. These pump actions may be manual or powered implementations.

Loading, injection and reconstitution actuation methods may include manual, mechanical, magnetic, pneumatic, gravity, and electrical. The preferred embodiment implements a manual actuation for medicine injection with a spring assist on the chamber load operation. Dispense operation is completed with a trigger completion indicator when the device is armed by removal of the needle cover. The industry has raised concerns about rate of injections which in this disclosure could be metered by negative mechanical advantage or port sizing to slow the injection rate of the fluid. Alternative approaches could leverage spring mechanical drivers to control the actuation of the dispense process. A pneumatic actuator could be used as already pre-charged or mechanically charged at the time of injection whereas to pressurize the medicament vial and in turn drive the medicine delivery pneumatically. This method would require volume metering to prevent introduction of air/gas to fluid passageway and therefor through the injection point. Electrical actuation may provide a means to increase ease of use and controlling the fluid delivery, however the reliability after extended shelf life and overall cost is a concern.

Ease of use for medical staff and especially for self-administration is a primary goal for syringe technology and consumer adoption. In the case of vaccination for COVID-19, demand for a worldwide distributed vaccine can be estimated to be approx. 8-1 IB doses. Important considerations for this mission include time reduction per administered dose, as well as simplicity of administration. Reduction of error is another important goal. The ability to streamline the process of reconstitution and front-line worker protection with a retracting safety needle will reduce the risk and reduce the operator stress (directly related to human error) in vaccine administration.

In instances where the present invention is used for preparation of a medicament, each of the medicament vials and displacement chamber are used to move and hold fluid being transferred between exchangeable vials. It is preferred to maintain a sterile isolated environment prior to arming for injection, and the present invention achieves this aim.

The mixing assembly comprises a first container such as a glass vial and a needle core consisting of a fluid passageway linking a second container such as a reciprocating chamber with an elastomeric sealed plunger. Once fluid is loaded from the first vial into the chamber, the first vial may be replaced by a second vial to which the loaded fluid may be forced via the needle core fluid passageway into the second vial. Continued actuation will cyclically draw and drive fluid via the fluid passageway between the chamber and glass vial. Alternatively, the once the fluid is in the second vial it may be swirled, and mixing may be visually confirmed in accordance with CDC/FDA requirements.

Although the invention employs an existing hypodermic needle, it is well suited to incorporate alternative needle technologies such as micro needles and needleless high- pressure fluid injectors or hybrids whereas a shorter hypodermic needle is used alongside high velocity, high pressure injection. An alternative embodiment employs a 45-degree angled base to allow and guide subcutaneous injections, along with optional grip surfaces to increase operator feel.

Precision grip provisions are often only associated in the prior art with dental syringes; however, the present invention provides dart/pencil-like grip options with fingertip actuation proximal to the injection needle. With this grip arrangement in conjunction with lateral actuation chamber it offers a one handed, one grip behavior where the administrator does not have to insert the needle, and then reposition his/her grip to inject. A one handed, one grip arrangement frees the other hand for stabilization of the injection target, which may be especially important in pediatric and veterinary applications.

The present invention preferably features a safety needle configuration wherein the dual needle core can fully retract into the housing and lock therein, preventing reuse. This protects administrators from unintended needle sticks, and prevents needle sharing and abuse.

Another embodiment captures the medication vial, which in turn secures the label which becomes a captive part of the used syringe for best practice recording of injected medication in fewer steps, presenting lower risk of human error. Because some needles retain sharpness only for one insertion, it is sometimes necessary to fill a syringe from one or more vials, and then change to a fresh needle prior to injection into a patient. Dull needles may cause discomfort, pain and degrade delivery. The need for multiple needles necessitates more packaging which leads to additional medical waste, exposes additional sterile risk, and exacerbates the potential of needle sticks and administrator injury.

The steps involved in operation of the present invention may be summarized as follows:

Basic non-linear syringe embodiment:

1. Collect vial, needle, syringe and remove from packaging.

2. Insert Luer Lock Needle

3. Remove metal cap from top of vial

4. Remove needle cover

5. While holding vial inverted pierce vial septum with needle tip.

6. Depress syringe inject button clearing syringe chamber into vial thus pressurizing to help facilitate drawing fluid back into syringe chamber when load button is depressed (opposite of Inject button)

7. Cycle buttons alternately as necessary to reduce air bubbles and release button to load material into syringe chamber

8. Remove vial.

9. Grip syringe between index finger and thumb, press needle into patient.

10. Depress syringe inject button injecting material into patient

11. Remove needle from patient

12. Apply safety needle cover or replace needle cover.

Single dose vial with syringe embodiment:

1. Collect medicament vial, syringe and remove from packaging. 2. Remove metal cap from top of vial and insert vial at the rear housing of syringe, allowing the load needle/spire to pierce vial septum until secured by retention clips of syringe core.

3. While holding upright with vial inverted, depress button pressuring vial and release button to return to its initial position, drawing liquid from the vial through the load needle into the syringe chamber.

4. Cycle button as necessary to reduce air bubbles and release to load syringe chamber

5. Remove patient injection needle cover. By removing the needle cover, the core valving changes position to ensure that the syringe chamber is no longer ported to load needle, but instead is ported to injection needle. In addition, needle auto retraction is now armed.

6. Grip syringe between Index finger and thumb and press needle into patient

7. Depress button injecting material, when plunger clears chamber the core and retained vial will retract axially and lock. Injection needle is now is a safe position, medicament vial and vial label are retained for record.

Reconstitution with syringe embodiment:

1. Collect medicament vial, diluent, syringe and remove from packaging.

2. Remove metal cap from top of diluent vial and insert diluent vial at the rear housing of syringe, allowing the load needle/spire to pierce vial septum until secured by retention clips of syringe core.

3. While holding upright with vial inverted, depress button pressuring vial and release button to return to its initial position, drawing liquid from the vial through the load needle into the syringe chamber.

4. Cycle button as necessary to reduce air bubbles

5. Remove diluent vial

6. Remove metal cap from top of medicament vial and insert vial at the rear housing of syringe, allowing the load needle/spire to pierce vial septum until secured by retention clips of syringe core. 7. While holding upright with vial inverted, depress button sending the diluent into the medicament vial.

8. Swirl or continue to cycle button to reconstitute.

9. Cycle button as necessary to reduce air bubbles and release to load syringe chamber

10. Remove patient injection needle cover. By removing the needle cover, the core valving changes position to ensure that the syringe chamber is no longer ported to the load needle but ported to injection needle. In addition, needle auto retraction is now armed.

11. Grip syringe between Index finger and thumb and press needle into patient

12. Depress button injecting material, when plunger clears chamber the core and retained vial will retract axially and lock. Injection needle is now is a safe position, medicament vial and vial label are retained for record.

In describing the above embodiments of the invention, specific terminology and simplification of data was selected for the sake of clarity and brevity. However, the invention is not intended to be limited to the specific terms so selected, and it is to be understood that each specific term includes all technical equivalents that operate in a similar manner to accomplish a similar purpose. While the invention has been described in its preferred embodiments, it is to be understood that the words which have been used are words of description rather than of limitation and that changes may be made within the purview of the appended claims without departing from the true scope and spirit of the invention in its broader aspects. Rather, various modifications may be made in the details within the scope and range of equivalents of the claims and without departing from the spirit of the invention.

The inventor further requires that the scope accorded the claims be in accordance with the broadest possible construction available under the law as it exists on the date of filing hereof (and of the application from which this application obtains priority, if any) and that no narrowing of the scope of the appended claims be allowed due to subsequent changes in the law, as such a narrowing would constitute an ex post facto adjudication, and a taking without due process or just compensation.