WO2024043891A1 - Aiguille de sécurité et son procédé d'utilisation - Google Patents

Aiguille de sécurité et son procédé d'utilisation Download PDF

Info

Publication number
WO2024043891A1
WO2024043891A1 PCT/US2022/041541 US2022041541W WO2024043891A1 WO 2024043891 A1 WO2024043891 A1 WO 2024043891A1 US 2022041541 W US2022041541 W US 2022041541W WO 2024043891 A1 WO2024043891 A1 WO 2024043891A1
Authority
WO
WIPO (PCT)
Prior art keywords
locking collar
needle
disposed
assembly
keyway
Prior art date
Application number
PCT/US2022/041541
Other languages
English (en)
Inventor
Maverick CISSELL
Original Assignee
ZUPPARDO, Jay Zachary
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 ZUPPARDO, Jay Zachary filed Critical ZUPPARDO, Jay Zachary
Priority to PCT/US2022/041541 priority Critical patent/WO2024043891A1/fr
Publication of WO2024043891A1 publication Critical patent/WO2024043891A1/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
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • 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
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/3245—Constructional features thereof, e.g. to improve manipulation or functioning
    • A61M2005/3247—Means to impede repositioning of protection sleeve from needle covering to needle uncovering position

Definitions

  • the invention relates to the field of retractable needles and syringes, namely an apparatus and method for quickly and safely deploying and retracting a needle to and from a pre-loaded syringe.
  • Autoinjectors or pre-loaded syringes which are selectively deployed to inject a medication into a patient, have long been used by medical professionals such as doctors, medical technicians, and first responders such as medics and firefighters.
  • medical professionals such as doctors, medical technicians, and first responders such as medics and firefighters.
  • One such autoinjector has been used to provide epinephrine to patients suffering from an acute allergic reaction under the name EpiPen®.
  • Typical autoinjectors generally include a needle housing which accommodates a plunger assembly with a pre-filled medication reservoir disposed therein.
  • the plunger assembly is coupled to the housing either directly or through an intermediate component such as a collar which allows a needle within the plunger assembly to be selectively “locked” or “unlocked” as needed by the user.
  • the needle portion is unlocked by rotating the plunger assembly relative to the housing until a pathway is cleared allowing for the needle to be deployed via actuation of the plunger assembly.
  • many autoinjectors include a spring which is compressed as the needle is deployed and then expanded to quickly retract the needle back into the housing after the medication has been injected into a patient.
  • Still other versions of autoinjectors only allow the needle to be locked into position relative to the housing afterthe needle has been deployed. Such autoinjectors therefore increase the likelihood of an inadvertent puncture from the needle, especially for those users who may be in a dynamic environment such as a moving ambulance.
  • the device should consist primarily of a housing and a removable plunger assembly.
  • the plunger assembly which is already preloaded with a dose of medication, should be easily coupled to the housing at the same time being automatically locked into a fixed position.
  • the needle and plunger assembly should comprise a means for being actuated that is safe and which does not prematurely expose the needle.
  • the current invention provides an apparatus for selectively engaging with a plunger assembly.
  • the apparatus includes a needle housing with a distal tip and a proximal end, a locking collar disposed within the needle housing, and a needle coupled to the locking collar.
  • a keyway is defined within a surface of the needle housing which includes a projection that extends towards the distal tip of the needle housing.
  • the locking collar itself comprises a key that is configured to engage with the projection.
  • the key extends in a radial direction from a substantially cylindrical body of the locking collar.
  • the keyway specifically includes a column portion which has a longitudinal length that is larger than a longitudinal length of the key disposed on the locking collar.
  • the keyway that is defined within the outer surface of the needle housing includes a first slot that is defined along a longitudinal axis of the needle housing and a second slot that is defined along a lateral surface of the needle housing, the second slot being perpendicularly orientated relative to the first slot.
  • the projection that is disposed within the keyway is specifically disposed on a proximal surface within the second slot.
  • the apparatus also has a spring that is disposed within the needle housing and coupled to the locking collar.
  • the locking collar comprises means for coupling with a distal end of the plunger assembly.
  • the key extends through the keyway that is defined within the surface of the needle housing and is further configured to traverse through the keyway.
  • the current invention further provides a method for selectively deploying a needle from an apparatus.
  • the method includes connecting a plunger assembly to a needle assembly, rotating a locking collar that is disposed within the needle assembly in a first direction in order to lock the locking collar in a fixed position relative to the needle assembly, and then pressing the plunger assembly in a distal direction relative to the needle assembly.
  • the locking collar is rotated in a second direction to unlock the locking collar and a needle coupled to the locking collar is then deployed from a distal tip of the needle assembly.
  • Rotating the locking collar disposed within the needle assembly in the first direction in order to lock the locking collar in a fixed position relative to the needle assembly specifically includes rotating a portion of the locking collar past a protrusion that is disposed within a keyway defined in the needle assembly.
  • the steps of connecting the plunger assembly to the needle assembly and rotating the locking collar disposed within the needle assembly in the first direction in order to lock the locking collar in a fixed position relative to the needle assembly are performed simultaneously.
  • rotating the portion of the locking collar past the protrusion disposed within the keyway defined in the needle assembly specifically includes moving a key that is disposed on the locking collar past an angled surface of the protrusion which extends into an arc slot of the keyway.
  • the key disposed on the locking collar may then be moved into a column portion of the arc slot.
  • pressing the plunger assembly in the distal direction relative to the needle assembly includes pushing the key within the column portion of the arc slot in the distal direction past the angled surface of the protrusion.
  • rotating the locking collar in the second direction to unlock the locking collar includes moving a key that is disposed on the locking collar into a longitudinal slot of the keyway.
  • the step of pressing the plunger assembly in the distal direction relative to the needle assembly includes moving the key disposed on the locking collar through the longitudinal slot of the keyway.
  • the method also includes applying a constant positive pressure to the locking collar.
  • the method may also include retracting the needle via the constant positive pressure that is applied to the locking collar. More specifically, retracting the needle via the constant positive pressure applied to the locking collar is done by moving the plunger assembly in a proximal direction relative to the needle assembly.
  • the embodiment may also include pressing the portion of the locking collar against at least one proximal surface of the keyway.
  • the step of coupling the plunger assembly to the needle assembly includes engaging a first plurality of threads that are disposed on the plunger assembly with a second plurality of threads that are disposed on the locking collar.
  • Fig. 1 A is a plan frontal view of the autoinjector of the current invention when coupled to a plunger assembly.
  • Fig. 1 B is a cross sectional view of the autoinjector seen in Fig. 1 A.
  • Fig. 1 C is a partially transparent view of the autoinjector seen in Fig. 1A.
  • FIG. 2A is a magnified view of the distal end of the autoinjector seen in Fig. 1 A where the needle housing portion of the autoinjector is transparent so as to view the internal components therein.
  • Fig. 2B is a magnified view of the transparent needle housing portion seen in Fig. 2A highlighting the interaction between the a keyway and a locking collar portion of the autoinjector.
  • FIG. 3 is an exploded view of the autoinjector seen in Fig. 1A.
  • the autoinjector 10 comprises a needle assembly 14 and a detachable or removable plunger assembly 16 which configures means for being selectively coupled to the needle assembly 14 as detailed further below.
  • the needle assembly 14 comprises a needle housing 12 which is substantially cylindrical in shape and which tapers in width along its longitudinal axis into a distal tip 18 with an aperture defined therein.
  • a locking collar 20 Within an internal volume of the needle housing 12 and adjacent to a proximal end of the needle housing 12 is a locking collar 20.
  • a spring 22 Disposed between the locking collar 20 and the distal tip 18 is a spring 22. Coupled to the locking collar 20 and disposed coaxially with the spring 22 is a needle 24 that is encased or disposed within a protective cover 26.
  • the plunger assembly 16 comprises a plunger housing 28 which is configured to accommodate a plunger 34 and medication reservoir 36 therein.
  • the plunger housing 28 further comprises a distal end 30 which is sized and shaped for insertion into the proximal end of the needle housing 12 and encloses a proximal end of the locking collar 20 as best seen in Fig. 1B.
  • the internal surface of the distal end 30 of the plunger housing 28 comprises a thread 32 which engages with a corresponding thread 38 disposed on the external cylindrical surface of the locking collar 20.
  • the thread 38 disposed on the locking collar 20 is a male thread
  • the thread 32 disposed in the distal end 30 of the plunger housing 28 is a matching or corresponding female thread
  • the thread 38 disposed on the locking collar 20 is a female orientated or configured thread
  • the thread 32 on the distal end 30 of the plunger housing 28 is a male orientated or configured thread.
  • neither the distal end 30 of the plunger housing 28 nor the locking collar 20 comprise any threads at all and instead are configured to form a tight friction or snap fit with one another when the proximal end of the locking collar 20 is inserted into the distal end 30 of the plunger housing 28.
  • the locking collar 20 is preferably comprised of soft plastic, rubber, or other lightweight, resilient or semi-rigid material known in the art.
  • the locking collar 20 further comprises at least one tab or key 40 which extends or protrudes from the substantially cylindrical shape of the locking collar 20 in a radial direction as best seen in Fig. 2B.
  • the key 40 extends radially from the locking collar 20 through an aperture or keyway 42 defined through the surface of the needle housing 12.
  • the keyway 42 in one embodiment specifically comprises a longitudinal slot or pathway 44 and an arc slot 46.
  • the arc slot 46 is perpendicularly orientated relative to the longitudinal slot or pathway 44 and is joined together with the longitudinal slot or pathway 44 at its corresponding proximal end.
  • the arc slot 46 portion of the keyway 42 further comprises an inclined or contoured surface or projection 48 along at least one internal edge of the arc slot 46.
  • the inclined projection 48 comprises a sloped or angled surface which gradually protrudes or extends from the inside surface of the arc slot 46 until terminating at a right angle.
  • Disposed adjacent to the inclined projection 48 within the arc slot 46 is a substantially rectangular shaft or column 50 which comprises a slightly longer longitudinal length than a longitudinal length of the key 40.
  • the key 40 traverses the arc slot 46 as well as the longitudinal slot 44 via the rotation of the locking collar 20 and the longitudinal movement of the locking collar 20, respectively, as detailed further below.
  • the autoinjector 10 may be used by first aligning the plunger assembly 16 with the needle assembly 14 as seen in Fig. 2A and then inserting the distal end 30 of the plunger housing 28 into the proximal end of the needle housing 12. Specifically, the distal end 30 of the plunger housing 28 is placed over and then coupled to a proximal end of the locking collar 20 by engaging their respective threads 32, 38 and then rotating the plunger housing 28 in a first direction relative to the locking collar 20. After the plunger housing 28 and locking collar 20 have been coupled together, the locking collar 20 will begin to rotate along with the plunger housing 28 within the internal volume of the needle housing 12.
  • the key 40 disposed within the keyway 42 will also rotate through the arc slot 46 until making contact with the inclined projection 48.
  • the key 40 presses against the surface of the inclined projection 48 and because the key 40 is comprised of resilient or semi-rigid material, begins to gradually deform more and more as the key 40 slides against the increasing inclined projection 48.
  • the key 40 continues to move along the surface of the inclined projection 48 until reaching its terminus at which point the key 40 then moves past the inclined projection 48 into the shaft or column 50.
  • the resilient material comprising the key 40 then relaxes, allowing it to return to its original, substantially rectangular shape.
  • the spring force of the spring 22 coupled to the distal portion of the locking collar 20 ensures that the key 40 remains within the shaft or column 50 portion of the arc slot 46, specifically with the key 40 pressed against the most proximal inside edge of the arc slot 46.
  • the key 40 With the key 40 firmly held in place within the arc slot 46 by the spring 22 and the projection 48, any further rotational movement of the locking collar 20 and the plunger housing 28 is prevented and the coupling process between the needle assembly 14 and the plunger assembly 16 is complete.
  • the spring 22 continuously applies a positive pressure against the locking collar 20, and because the shape of the inclined projection 48 effectively blocks or stops rotational movement of the key 40, any further rotational movement between the plunger assembly 16 and the needle assembly 14 is prevented without further user input.
  • the distal movement of the locking collar 20 also slides the key 40 disposed in the arc slot 46 in the distal direction, namely with the key 40 moving toward the opposing inner edge of the shaft or column 50.
  • the user may then rotate the plunger housing 28 coupled to the locking collar 20 in an opposing or second direction so as to rotate the key 40 past the inclined projection 48 and into the proximal most portion of the longitudinal slot 44 of the keyway 42 as seen in Fig. 2B.
  • the user may then apply additional distal pressure against the plunger housing 28 which in turn will move the locking collar 20 distally through the needle housing 12 with the key 40 likewise moving distally through the longitudinal slot 44 of the keyway 42.
  • the spring 22 continues to be compressed as the needle 24 and protective cover 26 move distally through the needle housing 12 and emerge from the tapered distal tip 18 of the needle assembly 14.
  • the needle 24 and protective cover 26 are pushed through the distal tip 18 where the user may remove the protective cover 26 manually and then inject the patient by applying the needle 24 to the patient and actuating the plunger 34 to dispense the medication from the medication reservoir 36.
  • the protective cover 26 may comprise an angled opening, aperture, or cannula tip so that when a maximum position is reached, the needle 24 continues to move in the distal direction until emerging from both the protective cover 26 and the distal tip 18 of the needle housing 12 where it then can be applied to the patient as discussed above.
  • the protective cover 26 remains stationary so that the needle 24 must first push through or pierce the protective cover 26 before emitted from the distal tip 18.
  • the protective cover 26 helps ensure that the needle 24 is not prematurely exposed from the needle assembly 12 without direct, user initiated actuation.
  • the user relaxes the pressure placed on the plunger 34 and plunger housing 28. With pressure no longer being applied, the now fully compressed spring 22 is allowed to expand which then quickly pushes the locking collar 20, and by extension the needle 24 coupled to the locking collar 20, in the proximal direction. As the locking collar 20 moves in the proximal direction, the needle 24 is withdrawn back through the distal tip 18 and into the internal volume of the needle housing 12.
  • the key 40 disposed on the locking collar 20 slides back through the longitudinal slot 44 of the keyway 42 until making abrupt contact with the most proximal edge of the longitudinal slot 44 as seen in Fig. 2B.
  • the autoinjector 10 provides a means to quickly “snap” or retract the needle 24 into the needle housing 12.
  • the locking collar 20 is once again rotated in the first direction by the user rotating the plunger 28, thereby pushing the key 40 past the protruded shape of the inclined projection 48 and returning the key 40 to the shaft of column 50 portion of the arc slot 46.
  • the key 40 disposed within the correspondingly shaped shaft or column 50 and behind the inclined projection 48 further rotation of the locking collar 20 is once again prevented without further distal actuation of the plunger assembly 16 by the user.
  • the spring 22 will always expand until the key 40 is pressed against the proximal most inner or inside edge of whichever surface the key 40 is adjacent too, whether it be the proximal end of the longitudinal slot 44 as seen in Fig. 2B, the inclined projection 48, or the proximal end of the shaft or column 50 portion of the arc slot 46.
  • the constant positive pressure provided by the spring 22, in addition to the inclined projection 48 and the tangential orientation of the arc slot 46 relative to the longitudinal slot 44, helps ensure that the needle 24 is not inadvertently exposed by the user prematurely.
  • the user may decouple and remove the plunger assembly 16 from the needle assembly 14.
  • the key 40 With the key 40 firmly disposed within arc slot 46 behind the protruded edge of the inclined projection 48, the user grips and rotates the plunger housing 28 in the second direction relative to the needle housing 12. The rotational movement of the key 40 in the second direction is prevented by the inclined projection 48 which in turn provides the resistance necessary to loosen and then disengage the threads 38 disposed on the locking collar 20 from the threads 32 disposed on the inside surface of the distal end 30 of the plunger housing 28 as the user continues to rotate the plunger housing 28.
  • the plunger assembly 16 Once the plunger housing 28 is fully disengaged or decoupled from the locking collar 20, the plunger assembly 16 may be separated from the needle assembly 14. A new or different plunger assembly comprising a pre-filled medication reservoir may then be coupled to the needle assembly 14 in the same manner disclosed above in order to administer a new medication or a second dose of a prior medication to the patient.
  • either or both of the needle assembly 14 and plunger assembly 16 may be properly disposed of after they have been decoupled.
  • Many alterations and modifications may be made by those having ordinary skill in the art without departing from the spirit and scope of the embodiments. Therefore, it must be understood that the illustrated embodiment has been set forth only for the purposes of example and that it should not be taken as limiting the embodiments as defined by the following embodiments and its various embodiments.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Environmental & Geological Engineering (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

Un auto-injecteur réutilisable contenant des mesures améliorées pour empêcher un déploiement dangereux d'une aiguille contenue dans celui-ci. L'auto-injecteur comprend un ensemble aiguille et un ensemble piston amovible. L'ensemble piston est accouplé au boîtier en même temps qu'il est automatiquement verrouillé dans une position fixe. Les ensembles aiguille et piston comprennent des moyens pour être actionnés qui sont sans danger et qui n'exposent pas prématurément l'aiguille. L'ensemble aiguille comprend un collier de verrouillage avec une clé disposée à l'intérieur d'un trajet défini qui peut être "verrouillé" ou "déverrouillé" lors de l'actionnement de l'utilisateur. Une fois que le médicament a été injecté dans un patient, l'aiguille peut se rétracter instantanément dans le boîtier par l'expansion d'un ressort interne. L'ensemble piston doit ensuite être retiré en faisant tourner à nouveau l'ensemble afin de "verrouiller" le collier de verrouillage en position, permettant à l'ensemble piston d'être libéré de celui-ci.
PCT/US2022/041541 2022-08-25 2022-08-25 Aiguille de sécurité et son procédé d'utilisation WO2024043891A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/US2022/041541 WO2024043891A1 (fr) 2022-08-25 2022-08-25 Aiguille de sécurité et son procédé d'utilisation

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/US2022/041541 WO2024043891A1 (fr) 2022-08-25 2022-08-25 Aiguille de sécurité et son procédé d'utilisation

Publications (1)

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WO2024043891A1 true WO2024043891A1 (fr) 2024-02-29

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ID=90013766

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PCT/US2022/041541 WO2024043891A1 (fr) 2022-08-25 2022-08-25 Aiguille de sécurité et son procédé d'utilisation

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20130226084A1 (en) * 2012-02-23 2013-08-29 Unitract Syringe Pty Ltd Retractable needle safety syringes
US20150133870A1 (en) * 2013-11-14 2015-05-14 Ansell Limited Safety syringe
US20170056600A1 (en) * 2012-06-20 2017-03-02 Safety Syringes, Inc. Contact Trigger Release Needle Guard with Elastic Spring

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20130226084A1 (en) * 2012-02-23 2013-08-29 Unitract Syringe Pty Ltd Retractable needle safety syringes
US20170056600A1 (en) * 2012-06-20 2017-03-02 Safety Syringes, Inc. Contact Trigger Release Needle Guard with Elastic Spring
US20150133870A1 (en) * 2013-11-14 2015-05-14 Ansell Limited Safety syringe

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