WO2022197775A1 - Seringue de sécurité non axiale - Google Patents

Seringue de sécurité non axiale Download PDF

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Publication number
WO2022197775A1
WO2022197775A1 PCT/US2022/020508 US2022020508W WO2022197775A1 WO 2022197775 A1 WO2022197775 A1 WO 2022197775A1 US 2022020508 W US2022020508 W US 2022020508W WO 2022197775 A1 WO2022197775 A1 WO 2022197775A1
Authority
WO
WIPO (PCT)
Prior art keywords
syringe
needle
pump
vial
injection needle
Prior art date
Application number
PCT/US2022/020508
Other languages
English (en)
Inventor
Andrew Schwartz
Original Assignee
B9 Injectors Llc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by B9 Injectors Llc filed Critical B9 Injectors Llc
Publication of WO2022197775A1 publication Critical patent/WO2022197775A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/14212—Pumping with an aspiration and an expulsion action
    • A61M5/1424—Manually operated pumps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A61M2005/2403—Ampoule inserted into the ampoule holder
    • A61M2005/2407—Ampoule inserted into the ampoule holder from the rear
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/1407—Infusion of two or more substances
    • A61M5/1409—Infusion of two or more substances in series, e.g. first substance passing through container holding second substance, e.g. reconstitution systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/14212—Pumping with an aspiration and an expulsion action
    • A61M5/14236—Screw, impeller or centrifugal type pumps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/3159—Dose expelling manners
    • A61M5/31593—Multi-dose, i.e. individually set dose repeatedly administered from the same medicament reservoir
    • A61M5/31595—Pre-defined multi-dose administration by repeated overcoming of means blocking the free advancing movement of piston rod, e.g. by tearing or de-blocking

Definitions

  • 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
  • Injection devices typically fall into two categories -manually operated devices and auto-injectors, and have typically been axial in actuation force and injection insertion direction.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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 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.
  • 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 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.
  • 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.
  • 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.
  • the Patient needle remains covered (sterile), when the needle cover is removed and device is armed for vaccine or medicament delivery.
  • 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.
  • 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.
  • manual or powered nonlinear rotary or reciprocating pumps are used to propel fluid medicament to and from chamber to core needles and vials.
  • 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.
  • 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.
  • 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.
  • the patient needle retracts under spring force into the body of the injection apparatus.
  • a sleeve surrounding the needle may be released to retract upon actuation.
  • actuation may be by electrical or pneumatic means, with or without a spring.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • device configurations of the invention allow combination of separate components such that the combined and mixed components are ready for administration.
  • the encompassed devices are additionally configured for use during administration of the administration-ready agent.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

Landscapes

  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L'invention concerne une seringue comprenant : un corps ; au moins un réservoir de fluide ; une aiguille d'injection montée sur le corps ; au moins une pompe située à l'intérieur du corps, en communication fluidique avec l'aiguille d'injection, la pompe étant conçue pour modifier la pression dans le réservoir de fluide à partir de la pression atmosphérique ambiante jusqu'au-dessus ou au-dessous de la pression atmosphérique ambiante, l'actionnement de la pompe étant sollicité par un élément de sollicitation et au niveau d'une extrémité distale de celui-ci est présente une surface pour un contact avec un doigt humain.
PCT/US2022/020508 2021-03-17 2022-03-16 Seringue de sécurité non axiale WO2022197775A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202163162209P 2021-03-17 2021-03-17
US63/162,209 2021-03-17

Publications (1)

Publication Number Publication Date
WO2022197775A1 true WO2022197775A1 (fr) 2022-09-22

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ID=83321120

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2022/020508 WO2022197775A1 (fr) 2021-03-17 2022-03-16 Seringue de sécurité non axiale

Country Status (1)

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WO (1) WO2022197775A1 (fr)

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3395704A (en) * 1964-11-19 1968-08-06 Frey Max Power operated syringe
US20090112155A1 (en) * 2007-10-30 2009-04-30 Lifescan, Inc. Micro Diaphragm Pump
US9872962B2 (en) * 2012-12-20 2018-01-23 Merck Sharp & Dohme Corp. Dual chamber mixing syringes and methods of using same
US10213556B2 (en) * 2011-12-08 2019-02-26 Unl Holdings Llc Accurate dose control mechanisms and drug delivery syringes

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3395704A (en) * 1964-11-19 1968-08-06 Frey Max Power operated syringe
US20090112155A1 (en) * 2007-10-30 2009-04-30 Lifescan, Inc. Micro Diaphragm Pump
US10213556B2 (en) * 2011-12-08 2019-02-26 Unl Holdings Llc Accurate dose control mechanisms and drug delivery syringes
US9872962B2 (en) * 2012-12-20 2018-01-23 Merck Sharp & Dohme Corp. Dual chamber mixing syringes and methods of using same

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