WO2022261458A1 - Ensemble stylo injecteur - Google Patents

Ensemble stylo injecteur Download PDF

Info

Publication number
WO2022261458A1
WO2022261458A1 PCT/US2022/033040 US2022033040W WO2022261458A1 WO 2022261458 A1 WO2022261458 A1 WO 2022261458A1 US 2022033040 W US2022033040 W US 2022033040W WO 2022261458 A1 WO2022261458 A1 WO 2022261458A1
Authority
WO
WIPO (PCT)
Prior art keywords
needle
needle shield
housing
extended position
locking member
Prior art date
Application number
PCT/US2022/033040
Other languages
English (en)
Inventor
David POGANSKI
Eugene Prais
Original Assignee
Embecta Corp.
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 Embecta Corp. filed Critical Embecta Corp.
Publication of WO2022261458A1 publication Critical patent/WO2022261458A1/fr

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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
    • A61M5/34—Constructions for connecting the needle, e.g. to syringe nozzle or needle hub
    • 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
    • A61M5/3202—Devices for protection of the needle before use, e.g. caps
    • 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
    • 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
    • A61M5/50—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 having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile

Definitions

  • the disclosure is directed to a pen needle assembly adapted for attachment to a medication delivery device such as a medication delivery pen.
  • the pen needle assembly has a pen needle with a retractable needle shield such that the needle shield can be retracted during use and extended to a locked position after use to cover the needle.
  • Pen needles are used to attach to a medication pen and are especially useful for delivering self-administered injectable medications such as insulin.
  • Pen needles typically include a hub and a needle extending from the hub for injecting the medication into the patient.
  • the outer cover is placed over the used pen needle to assist in removing the pen needle from the delivery device and covering the used needle after use.
  • Other pen needle devices include a retractable needle shield that retracts during use and moves to an extended position after use to cover the needle and prevent inadvertent needle stick.
  • Some of the prior pen needles include a retractable needle shield that locks in place after use. Nonetheless, there is still a need in the industry for improvements to the pen needles.
  • the present disclosure relates to a pen needle including: a hub including a proximal end configured for coupling to a delivery device and a distal end including a needle extending from the distal end; a housing coupled to the hub and including an open distal end; a needle shield received in the housing and movable among a first extended position covering the needle, a retracted position exposing the needle, and a second extended position such that the needle shield locks with the housing; and a biasing member extending between the housing and the needle shield to bias the needle shield in a distal direction with respect to the hub, the biasing member expanding when the needle shield moves to the retracted position and contracts to move the needle shield to the second extended position.
  • the present disclosure relates to a pen needle, wherein the biasing member is an elastic member including a first portion coupled to the housing and a second portion coupled to the needle shield, wherein contracting of the elastic member moves the needle shield to the second extended position.
  • the biasing member is an elastic member including a first portion coupled to the housing and a second portion coupled to the needle shield, wherein contracting of the elastic member moves the needle shield to the second extended position.
  • the present disclosure relates to a pen needle, wherein the housing includes an internal collar with an engagement member, and wherein the first portion of the elastic member is coupled to the engagement member and wherein the second portion of the elastic member is coupled to the needle shield.
  • the present disclosure relates to a pen needle, wherein the needle shield includes a locking member, the locking member transitioning from a first configuration to a second configuration by contacting the hub when the needle shield moves to the retracted position, and wherein the locking member in the second configuration locks with the housing when the needle shield is in the second extended position.
  • the present disclosure relates to a pen needle, wherein the locking member bends relative to the needle shield in the second configuration, and wherein the housing includes an inner sleeve to engage a proximal end of the locking member when the needle shield is in the second extended position.
  • the present disclosure relates to a pen needle, wherein the hub includes a distally extending projection with an inclined surface configured to contact the locking member and bend the locking member outward when the needle shield moves to the retracted position.
  • the present disclosure relates to a pen needle, wherein the elastic member includes a first end coupled to a first engagement member of the housing and a second end coupled to a second engagement member of the housing, the elastic member extending between the first engagement member and the second engagement member, and wherein a proximal end of the needle shield contacts the elastic member between the first end and the second end.
  • the present disclosure relates to a pen needle, further including an engagement member projecting outward from a proximal end of the needle shield, the engagement member coupled to the second portion of the biasing member to bias the needle shield in the distal direction.
  • the present disclosure relates to a pen needle, wherein the housing includes an arm extending proximally from the open distal end of the housing, and the needle shield includes a locking member configured for locking with the arm when the needle shield is in the second extended position.
  • the present disclosure relates to a pen needle, wherein the locking member of the needle shield includes a plurality of flexible tabs, and wherein the distal end of the arm deflects the plurality of flexible tabs and the plurality of flexible tabs lock to the locking member when the needle shield moves to the second extended position.
  • the present disclosure relates to a pen needle including: a hub including a proximal end configured for coupling to a delivery device and a distal end including a needle extending from the distal end; a housing coupled to the hub and including an open distal end; and a needle shield received in the housing, the needle shield including a locking member transitioning from a first configuration to a second configuration by engaging the hub when the needle shield moves from a first extended position covering the needle to a retracted position to expose the needle, and wherein the locking member in the second configuration locks the needle shield in a second extended position to cover the needle.
  • the present disclosure relates to a pen needle, further including a biasing member extending between the housing and the needle shield to bias the needle shield in a distal direction relative to the hub to the second extended position to cover the needle.
  • the present disclosure relates to a pen needle, wherein the biasing member is an elastic member including a first portion coupled to the housing and a second portion contacting a proximal end of the needle shield, the elastic member expanding when the needle shield moves to the retracted position and contracting when the needle shield moves to the second extended position.
  • the biasing member is an elastic member including a first portion coupled to the housing and a second portion contacting a proximal end of the needle shield, the elastic member expanding when the needle shield moves to the retracted position and contracting when the needle shield moves to the second extended position.
  • the present disclosure relates to a pen needle, wherein the elastic member includes a first end coupled to a first engagement member of the housing and a second end coupled to a second engagement member of the housing, the elastic member extending between the first engagement member and the second engagement member, and wherein a proximal end of the needle shield contacts the elastic member between the first end and the second end.
  • the present disclosure relates to a pen needle, wherein the locking member bends from the first configuration radially outward with respect to the needle shield to the second configuration by contact with the hub, and wherein the housing includes an internal collar that contacts a proximal end of the locking member when the needle shield is in the second extended position.
  • the present disclosure relates to a pen needle, wherein the housing includes a distally extending projection including an inclined surface configured to contact the locking member and bend the locking member outward when the needle shield moves to the retracted position.
  • the present disclosure relates to a pen needle including: a hub including a proximal end configured for coupling to a delivery device and a distal end including a needle extending from the distal end; a housing coupled to the hub, the housing including an open distal end; a needle shield received in the housing and movable from a first extended position covering the needle, a retracted position exposing the needle, and a second extended position covering the needle, the needle shield including a locking member configured for locking with the housing when the needle shield moves to the second extended position; and an elastic biasing member including a first end coupled to the housing and a second end coupled to the needle shield to bias the needle shield in a distal direction by contraction of the elastic biasing member.
  • the present disclosure relates to a pen needle, wherein the housing includes an arm extending in a proximal direction and including a proximal end with a distally facing surface, and the locking member on the needle shield engaging the distally facing surface of the arm when the needle shield is in the second extended position.
  • the present disclosure relates to a pen needle, wherein the locking member of the needle shield includes a plurality of flexible tabs, and wherein the distal end of the arm extends between and deflects the plurality of flexible tabs when the needle shield moves to the second extended position and couples to the locking member.
  • the present disclosure relates to a pen needle, wherein the arm contacts an outer surface of the locking member when the needle shield is in the first extended position, the arm separates from the locking member when the needle shield is in the retracted position, and the arm engages the locking member to lock the needle shield when the needle shield is in the second extended position.
  • the present disclosure relates to a pen needle, wherein the elastic member includes a first end coupled to a first engagement member of the housing and a second end coupled to a second engagement member of the housing, the elastic member extending between the first engagement member and the second engagement member, and wherein a proximal end of the needle shield contacts the elastic member between the first end and the second end.
  • the present disclosure relates to a pen needle, wherein the locking member bends relative to the needle shield in the second configuration, and wherein the housing includes an inner sleeve to engage a proximal end of the locking member when the needle shield is in the second extended position.
  • the present disclosure relates to a pen needle, wherein the hub includes a distally extending projection with an inclined surface configured to contact the locking member and bend the locking member outward when the needle shield moves to the retracted position.
  • FIG. 1 is a perspective view of an exemplary embodiment of a pen needle
  • Fig. 2 is an exploded side view showing the needle hub, housing and needle shield;
  • Fig. 3 is a perspective view showing the interior components of the pen needle;
  • Fig. 4 is a perspective view of the pen needle of Fig. 3 showing the needle shield in a retracted position;
  • Fig. 5 is a cross sectional view of the pen needle showing the needle shield in a retracted position
  • Fig. 6 is a perspective view showing the needle shield in the extended and locked position
  • Fig. 7 is a cross sectional view showing the needle shield in the locked position
  • Fig. 8A and Fig. 8B are an end view showing the transition of the locking member
  • Fig. 9 is a top perspective view of the housing of the pen needle
  • Fig. 10 is a bottom perspective side view of the housing of the pen needle
  • Fig. 11 is a cross sectional view of the housing of the pen needle taken along line 11-11 of Fig. 9;
  • Fig. 12 is a cross sectional view of the housing taken along line 12-12 of Fig. 9;
  • Fig. 13 is a perspective end view of the needle shield;
  • Fig. 14 is a bottom perspective view of the needle shield;
  • Fig. 15 is a perspective view of the pen needle showing the needle shield in the first position
  • Fig. 16 is perspective view of the pen needle of Fig. 15 showing the needle shield in the retracted position;
  • Fig. 17 is a perspective view of the pen needle showing the needle shield in the locked position
  • Fig. 18 is a perspective view of the pen needle of Fig. 15;
  • Fig. 19 is an exploded view of the pen needle of Fig. 15;
  • Fig. 20 is a cross sectional view of the pen needle
  • Fig. 21 is a cross sectional view of the housing
  • Fig. 22 is a perspective view of the adapter
  • Fig. 23 is a perspective view of the internal collar
  • Fig. 24 is a perspective view of the needle shield
  • Fig. 25 is a perspective view of an embodiment of the needle shield shown of Fig. 1;
  • Fig. 26 is a cross sectional view of the needle shield of Fig. 25.
  • the present disclosure is generally directed to a pen needle assembly having a pen needle with a retractable needle shield where the needle shield can lock in an extended position to cover the end of the needle after use.
  • the pen needle of the present disclosure can be attached to a delivery pen or other delivery device, where the pen needle includes a needle.
  • the pen needle can include a needle shield that is in an extended position before use and can retract to expose a needle or cannula during use, and then deployed after use to cover the needle or cannula and lock in an extended position to cover the distal end of the needle after use.
  • the needle shield can lock in the extended position after use by a linear movement of the needle shield without rotation of the needle shield to a locked position.
  • the needle shield can be biased outwardly by a biasing member that can be produced at a lower cost than the prior biasing members while maintaining the efficiency and simplicity of the operation of the pen needle and the deployment of the needle shield after use.
  • the biasing member is an elastic member, such as a rubber band-like member, connected to the needle shield. The biasing member expands when the needle shield is retracted and contracts to the original condition to move the needle shield to the extended position.
  • the elastic member can have a first portion attached to the housing and a second portion engaging the needle shield.
  • the elastic member is connected at both ends to opposite sides of the housing where the needle shield contacts the elastic member at a location between the ends of the elastic member.
  • the elastic member has a first end coupled to the housing and second end coupled to the inner shield to bias the needle shield to the extended position.
  • the needle shield that can be biased outwardly by a biasing member that can be produced at a lower cost than the prior biasing members while maintaining the efficiency and simplicity of the operation of the pen needle and the deployment of the needle shield after use.
  • the “distal” direction is in the direction of the injection site, and the “proximal direction” is the opposite direction.
  • the “axial” direction is along the longitudinal axis of the injection device.
  • the needle cannula is generally arranged axially in the device.
  • “Radially” is a direction perpendicular to the axial direction.
  • “radially inward” generally means closer to the needle.
  • “Circumferentially” means arranged around the circumference, so that threads are arranged circumferentially on the end of a threaded fitting.
  • the “top” view of a pen needle is looking at the pointed end of the needle.
  • the different features of the embodiments can be used in combination with and used with other embodiments as long as the combined parts are not inconsistent with or interfere with the operation of the device and assembly.
  • the term “substantially” refers to a characteristic that possessed the characteristic or mostly the characteristic, but not necessary entirely the characteristic.
  • the present disclosure provides a pen needle 10 that includes a hub 12, a housing 14, and a needle shield 16 having a biasing member 18.
  • the housing 14 can have a proximal end 20 and a distal end 22.
  • the hub 12 and the housing 14 can be formed as two members that are coupled together.
  • the housing 14 and hub 12 can be formed a single one-piece member.
  • the pen needle assembly of the disclosure includes a pen needle 10.
  • An outer cover and a seal for enclosing the pen needle 10 until ready for use can generally be included.
  • the pen needle 10 can be configured for attaching to a delivery pen in a known manner.
  • the delivery pen is not shown in the drawings for clarity.
  • the outer cover can be coupled to the distal end of the pen needle.
  • the closure or peel tab can generally be provided over the open end of the cover to maintain the needle hub assembly in a sterile condition until ready for use.
  • the delivery pen can be a typical delivery pen or other medication delivery device as known in the art for dispensing and delivering a medication or pharmaceutical such as insulin.
  • An example of a suitable delivery pen is disclosed in U.S. Patent No. 9,774,844, which is hereby incorporated by reference in its entirety.
  • the pen needle 10 can include the hub 12.
  • the hub 12 can have a needle 34 extending distally from the hub 12.
  • the hub 12 comprises a proximal end configured for coupling to a delivery device and a distal end comprising the needle 34 extending from the distal end.
  • the housing 14 is coupled to the hub 12 and the housing comprises an open distal end.
  • the pen needle 10 can include the housing 14 that can receive the hub 12 and the needle shield 16 that can move axially within the housing 14 and can move relative to the hub 12.
  • the needle shield 16 can be received in the housing 14. As shown at least in Fig.
  • the hub 12 can include a side wall comprising an inner thread 25 that can facilitate the coupling of the hub 12 to the delivery device.
  • the side wall 24 can include a flange 26 extending radially outward from a proximal end 28.
  • the hub 12 comprises the proximal end 28 configured for coupling to a delivery device.
  • the hub 12 can have a distal end 30 with projection 32 extending in a distal direction.
  • a needle 34 can extend from the distal end 30 and be received in an axial bore.
  • An adhesive 36 can be used to attach the needle to the bore.
  • a cover may be fitted over the end of the hub 12 to cover the needle 34 during storage until the pend needle 10 is ready to use.
  • the pen needle 10 can be connected to a delivery device for delivering a medication to the patient by the needle 34.
  • the needle shield 16 in the ready position can be in a first extended position, as shown at least in Fig. 3, such that the biasing member 18 retains the needle shield 16 in the first extended position.
  • the needle shield 16 that is received in the housing 14 can be movable among a first extended position covering the needle 34, a retracted position exposing the needle 34, and a second extended position such that the needle shield 16 locks with the housing 14.
  • the movable needle shield 16 can retract during use to expose the needle 34 and can be deployed by moving or sliding outwardly after use to cover the end of the needle 34 and prevent further use or accidental needle stick.
  • the needle shield 16 can be pressed against the surface of the skin of the patient so that the needle shield 16 retracts to expose the needle 34, as shown at least in Fig. 4, and the needle 34 can penetrate the skin of the patient.
  • the axial movement of the needle shield 16 to the retracted position, as shown at least in Fig. 4, can stretch the biasing member 18 to apply a biasing force against the needle shield 16 in the distal direction.
  • the needle 34 can then be withdrawn from the patient to release the force on the end of the needle shield 16 such that the biasing member 18 can bias the needle shield 16 to the second extended position.
  • the biasing member 18 expands when the needle shield 16 moves to the retracted position and contracts to move the needle shield 16 to the second extended position.
  • the biasing member 18 is provided in connection with the shield 16.
  • the biasing member 18 can be an elastic member that can stretch and contract to move the needle shield 16 relative to the housing 14.
  • the biasing member 18 can be provided between the needle shield 16 and the housing 14 to bias the needle shield 16 outwardly to cover the needle 34.
  • the biasing member 18 extends between the housing 14 and the needle shield 16 to bias the needle shield 16 in a distal direction with respect to the hub 12.
  • the biasing member 18 can be a rubber band-like member that can stretch and have sufficient memory to return to its original shape and dimension.
  • the biasing member 18 is an elastic member, such as a rubber band-like member, connected to the needle shield 16. In its original state, the biasing member 18 biases the shield 16 toward the extended position.
  • the biasing member 18 can expand when the needle shield 16 is retracted to the retracted position when a compressive force is applied to the shield, such as, for example, when the shield is pressed against the skin of the patient. Once the compressive force on the shield 16 is removed, the biasing member can contract to the original condition to move the needle shield 16 to the extended position.
  • the side wall 24 of the hub 12 can have an axial rib 38 that is received in an axial groove 40 formed on the inner surface of the housing 14.
  • An annular rib 42, as shown at least in Fig. 2, on the side wall 24 of the hub 12 can be received in an annular grove 44, as shown at least in Fig. 5, on the housing for coupling the hub 12 to the housing 14.
  • the projection can have two spaced apart projecting members 32 extending distally from the hub 12 for contacting the needle shield 16.
  • the projecting members 32 can be spaced a distance such that the needle 34 extends between the projecting member 32.
  • the projecting members 32 can have a flat distal end in the embodiment shown and inclined surfaces 48 that slope outward from the distal end 30 toward the proximal end 28 of the hub 12.
  • the housing 14 is coupled to the hub 12 and the housing 14 comprises an open distal end.
  • the housing 14 can include a side wall 50 with a distal end 52 forming an opening 54.
  • an inner sleeve 56 can be provided at the distal end 52 and spaced inwardly in a radial direction from the side wall 50.
  • the inner sleeve 56 can be spaced from the side wall 50 to define an annular recess 58.
  • the inner sleeve 56 can be connected to the side wall 50 by radially ribs 60 extending between the side wall 50 and the inner sleeve 56.
  • the ribs 60 can engage with the biasing member 18 and support the inner sleeve 56.
  • the ribs 60 can be spaced apart in the embodiments shown to form open area between the adjacent ribs 60.
  • the biasing member 18 can be a continuous band that extends between the ribs 60 and below a proximal end of the inner sleeve 56.
  • the biasing member 18 can be stretched between the ribs 60 to apply a tension sufficient to retain the inner shield 16 in the ready position, as shown at least in Fig. 3.
  • the inner sleeve 56 can include guide ribs 62 extending in an axial direction for guiding the needle shield 16.
  • the guide ribs 62 can extend from a distal end of the inner sleeve 56 and can have a proximal end spaced distally from a proximal end of the inner sleeve 56.
  • two guide ribs 62 can be provided on opposite sides of the opening 54 in the inner sleeve 56.
  • a longitudinally extending recess 64 can be provided on the inner sleeve 56 between the adjacent guide ribs 62.
  • Two longitudinally extending recesses 64 can be provided on opposite sides of the inner sleeve 56.
  • the longitudinally extending recesses 64 can have an open end at the distal end of the inner sleeve 56 and closed end formed by a ledge 66 at a proximal end of the inner sleeve 56.
  • the ledge 66 can form a stop member for limiting the axial movement of the inner sleeve 56.
  • the needle shield 16 can have a side wall 70 with a distal end wall 72 having an opening 74 for the needle 34 to pass through the needle shield 16.
  • the side wall 70 of the needle shield 16 can have a longitudinally extending recess 76 forming a groove for mating with the longitudinally extending rib 62 for guiding the needle shield 16.
  • the proximal end of the recess 76 can have a ledge 78 forming a stop for limiting the axial movement of the needle shield 16 in a distal direction and retaining the needle shield 16 in the opening of the inner sleeve.
  • the needle shield 16 comprises the locking member 80 transitioning from the first configuration to the second configuration by engaging the hub 12 when the needle shield 16 moves from the first extended position covering the needle 34 to a retracted position to expose the needle 34.
  • the locking member 80 bends from the first configuration radially outward with respect to the needle shield 16 to the second configuration by contact with the hub 12.
  • the housing 14 can include the internal collar 116 that couples with the locking member 80 on the needle shield 16 when the needle shield 16 moves to the second extended position after use.
  • the locking member 80 in the second configuration can lock the needle shield 16 in a second extended position to cover the needle 34.
  • the locking member 80 can undergo change of state during use.
  • the locking members 80 can be formed integrally with the body of the needle shield 16.
  • the needle shield 16 and the locking members 80 can be formed from a material such that the locking members 80 can bend at the distal end of the locking members 80 and retain the shape after bending.
  • the needle shield 16 can be made of a plastic material that can bend and retain its bent shape or configuration.
  • the locking member 80 can transition or change from a first configuration, as shown at least in Fig. 8A, to a second configuration, as shown at least in Fig. 8B, such that the locking member 80 locks the needle shield 16 and prevents movement of the needle shield 16 after use.
  • the locking member 80 can be provided on the needle shield 16.
  • the locking member 80 can contact the hub 12 by retracting the needle shield 16 during use.
  • the contact with the hub 12 can bend or deform the locking member 80 outward from the needle shield 16.
  • the hub 12 comprises the distally extending projecting members 32 with the inclined surface 48 that is configured to contact the locking member 80 and bend the locking member 80 outward when the needle shield 16 moves to the retracted position.
  • the locking member 80 can transition from a first configuration to a second configuration by contacting the hub 12 when the needle shield 16 moves to the retracted position. In some embodiments, the locking member 80 can bend relative to the needle shield 16 in the second configuration. The locking member 80 can contact the hub 12 by a retracting movement of the needle shield 16 to transition the locking member 80 from the first configuration to the second configuration. [0078] In some embodiments, as shown at least in Figs. 6 and 7, the locking member 80 in the second configuration can lock with the housing 14 when the needle shield 16 is in the second extended position.
  • the locking member 80 can bend from the first configuration such that the needle shield 16 can slide axially relative to the housing 14 and the hub 12 to the second configuration such that the locking member 80 can lock the needle shield 16 in the second extended position after use to cover the needle 34.
  • the locking members 80 being in the second configuration such that the locking members 80 are angled outwardly from the needle shield 16, can slide over the ledge 66 and snap into the recess 64.
  • the needle shield 16 as shown at least in Figs. 13 and 14, can have opposite sides and a locking member 80 formed on each side.
  • the sides of the needle shield 16 can be substantially flat.
  • Each locking member 80 can have a proximal end 82 at a proximal end 84 of the needle shield 16. As shown, the proximal end 82 of the locking member 80 can be spaced distally from the proximal end 84 of the needle shield 16.
  • the locking members 80 can move from a first configuration such that the needle shield 16 can slide in a proximal direction with respect to the inner sleeve 56 and the housing 14, as shown at least in Fig. 3, to a second configuration, as shown at least in Fig, 4, such that the proximal end 82 of the locking members 80 are spaced radially outward from the needle shield 16.
  • the biasing member 18 can be stretched between the ribs 60 and engage the proximal end 84 of the needle shield 16.
  • the proximal end 82 of the locking members 80 can engage the ledge 66 to prevent movement of the needle shield 16 in the proximal direction after use and lock the needle shield 16 in the second extended position.
  • the pen needle 10 in the deployed state can prevent further movement of the needle shield 16 after use.
  • the housing 14 comprises the inner sleeve 56 to engage the proximal end 82 of the locking member 80 when the needle shield 16 is in the second extended position.
  • the proximal end 82 of the locking member 80 can engage the inner sleeve 56 of the housing 14 when the needle shield 16 moves to the second extended position such that the needle shield 16 is locked to prevent retracting after use.
  • the inner sleeve 56 can include the recess 64 or a shoulder that receives the proximal end 82 of the locking member 80 when the needle shield 16 is moved to the second extended position after use.
  • the locking member 80 can have a substantially flat end surface 90 and an inclined surface 92 on an inner face of the locking member 80.
  • a slot 86 may be provided to facilitate the movement of the locking member 80.
  • the locking member 80 can contact the incline surface 92 on the needle hub 12 when the needle shield 16 retracts during use. The retracting movement of the needle shield 16 can bring the inclined surface 92 of the locking member 80 into engagement with the inclined surface 48 of the extension members 46 to bend the locking members 80 outwardly with respect to the needle shield 16.
  • the proximal end 84 of the needle shield 16 can have recesses 94 between the locking members 80 for receiving the biasing member 18.
  • the ribs 60 can form an engagement member and can include a notch 96 for receiving the biasing member 18.
  • the housing 14 can have a side wall 110 with an open proximal end 112 and a distal end wall 114.
  • the housing 14 comprises an internal collar 116 with one or more engagement members 126.
  • the one or more engagement members 126 can be lugs.
  • the housing 14 can have an internal collar 116 on the inner surface of the distal end wall 114 for receiving the needle shield 16 and allowing the needle shield 16 to slide axially relative to the housing 14 and the internal collar 116.
  • the housing 14 comprises an arm 118 extending proximally from the open distal end of the housing 14.
  • the internal collar 116 on the housing 14 can include a proj ecting member, such as the flexible arms 118, extending in a proximal direction that cooperates with the locking member 80 on the needle shield 16.
  • the internal collar 116 can include the arms 118 extending in a proximal direction.
  • the arms 118 are flexible.
  • the needle shield 16 can be initially in a first extended position to cover the needle 34.
  • the arms 118 can be initially in a first position contacting an outer surface of the locking member 80.
  • the arm 118 contacts an outer surface of the locking member 80 when the needle shield 16 is in the first extended position. Moving the needle shield 16 to the retracted position, as shown in Fig. 16, can separate the arms 118 so that the needle shield 16 can slide to the retracted position. In some embodiments, the arm 118 separates from the locking member 80 when the needle shield 16 is in the retracted position. The needle shield 16 can be pressed against the skin of the patient to retract the needle shield 16 to expose the needle 34 so that the needle pierces the skin of the patient.
  • the arms 118 can have a projection 122 extending outwardly from the arm 118 and forming a locking member of the housing 14.
  • the projection 122 can have a distally facing surface forming a ledge 124 and an inclined proximal surface 120 that converges to the proximal end.
  • the housing 14 includes the arm 118 extending in a proximal direction and comprising a proximal end with a distally facing surface.
  • the housing 14 comprises the distally extending projection 122 comprising the inclined proximal surface 120 configured to contact the locking member 80 and bend the locking member 80 outward when the needle shield 16 moves to the retracted position.
  • the internal collar 116 can include one or more engagement members 126 oriented on opposite sides and forming a hook-like configuration.
  • the needle shield 16 can have a body 128, as shown at least in Fig. 19 and Fig. 24, having one or more engagement members 130 projecting outward in a radial direction.
  • the one or more engagement members 130 can be lugs, hooks, or ledges.
  • the one or more engagement members 130 project outwards from the proximal end 82 of the needle shield 16.
  • a distal sleeve 132 can extend from a distal end of the body 128.
  • the locking member 80 can project outwardly from opposite sides of the body 128, as shown at least in Fig. 19 and Fig. 24.
  • the locking member 80 of the needle shield 16 includes a plurality of flexible tabs 136.
  • the plurality of flexible tabs 136 can couple with the one or more engagement members 130 of the housing 14.
  • the distal end of the arms 118 deflect the plurality of flexible tabs 136.
  • the locking members 80 can be formed by the plurality of flexible tabs 136 that converge toward each other at a proximal end 84 of the needle shield 16 to define a gap 138 between the ends of the plurality of flexible tabs 136.
  • releasing the insertion force on the pen needle 10 to withdraw the needle 34 from the patient can allow the needle shield 16 to slide to the second extended position, as shown at least in Fig. 17.
  • the distal end of the arm 118 extends between and deflects the plurality of flexible tabs 136 when the needle shield 16 moves to the second extended position and couples to the locking member 80. Moving the needle shield 16 to the second extended position forces the end of the arms 118 between the flexible tabs 136 so that the ledge 124 of the arms 118 can hook onto the ends of the flexible tabs 136.
  • the locking member 80 on the needle shield 16 engages the distally facing surface of the arm 118 when the needle shield 16 is in the second extended position.
  • the arm 118 engages the locking member 80 to lock the needle shield 16 when the needle shield 16 is in the second extended position.
  • the housing 14 includes the internal collar 116 that contacts the proximal end 84 of the locking member 80 when the needle shield 16 is in the second extended position.
  • the needle shield 14 comprises the flexible tabs 136 configured for locking with the arms 118 when the needle shield 16 is in the second extended position.
  • the plurality of flexible tabs 136 lock to the locking member 80 when the needle shield 16 moves to the second extended position. The flexible tabs 136 can lock the needle shield 16 to the internal collar 116 to lock the needle shield 16 in the second extended position to cover the needle 34 and prevent re-use of the pen needle 10.
  • the biasing member 18 extends between the housing 14 and the needle shield 16 to bias the needle shield 34 in a distal direction relative to the hub 12 to the second extended position to cover the needle 34.
  • the biasing member 18 can be an elastic member 140 that can be provided to bias the needle shield 16 distally with respect to the housing 14
  • the elastic member 140 is an elastic band.
  • the elastic member 140 can be a continuous elastic member.
  • the elastic member 140 can be connected at both ends to opposite sides of the housing 14 such that the needle shield 16 contacts the elastic member 140 at a location between the ends of the elastic member 140.
  • the elastic member 140 comprises a first end coupled to a first engagement member 126 of the housing 14 and a second end coupled to a second engagement member 126 of the housing 14.
  • the elastic member 140 extends between the first engagement member 126 and the second engagement member 126.
  • the proximal end 84 of the needle shield 16 can contact the elastic member 140 between the first end and the second end.
  • the elastic member 140 can have a first portion attached to the housing 14 and a second portion that can engage the needle shield 16.
  • the elastic member 140 can have a first end coupled to the housing 14 and a second end coupled to the needle shield 16 to bias the needle shield 14 to the extended position.
  • the elastic biasing member 140 comprises a first end coupled to the housing 14 and a second end coupled to the needle shield 16 to bias the needle shield 16 in a distal direction by contraction of the elastic biasing member 140.
  • the elastic member 140 comprises a first portion coupled to the housing 14 and a second portion coupled to the needle shield 16.
  • the elastic member 140 comprises a first portion coupled to the housing 14 and a second portion contacting the proximal end 84 of the needle shield 16.
  • the pen needle 10 can be assembled, as shown in Fig. 15, such that the needle shield 16 is connected to the internal collar 116 by the elastic member 140 in the ready position.
  • the elastic member 140 has the first portion coupled to the one or more engagement members 126 of the internal collar 116 and the second portion coupled to the needle shield 16.
  • the elastic member 140 has the first portion connected to the engagement member 126 of the internal collar 116 and the second portion connected to the engagement member 130 of the needle shield 16.
  • the one or more engagement members 130 can be coupled to the second portion of the elastic member 140 to bias the needle shield 16 in the distal direction.
  • the elastic member 140 can have a memory that is sufficient to expand when the needle shield 16 moves to the retracted position and returns to the original position. In some embodiments, the elastic member 140 expands when the needle shield 16 moves to the retracted position and contracts when the needle shield 16 moves to the second extended position. In some embodiments, contracting of the elastic member 140 moves the needle shield 16 to the first extended position or the second extended position.
  • the housing 14 can have an open proximal end for receiving an adapter 144 for connecting the pen needle 10 to a delivery device.
  • the body of the housing 14 can include threads 142 for coupling the adapter 144 to the housing 14.
  • the threads 142 can include an axial portion 146 and an inclined portion 148.
  • the adapter 144 can include circumferentially extending flexible arms 150 at the distal end.
  • the free ends of the flexible arms 150 can have one or more tabs 152 with an inclined surface.
  • the one or more tabs 152 can be outwardly projecting tabs.
  • the one or more tabs 152 can slide in the threads 142 to couple the adapter to the housing 14.
  • the tabs 152 may have a triangular shape with an inclined surface 154.
  • the internal collar 116 can be coupled to the distal end wall 114 of the housing 14 by hooked tabs 156 that can extend through the open end of the internal collar 116.
  • the internal collar 116 can be integrally formed with the housing 14 as a one-piece member.
  • the needle shield 16 can have a configuration for sliding in the inner sleeve 56 of the housing 14.
  • the locking member 80 on the needle shield 16 can move in a direction transverse to the axial dimension of the pen needle 10 and the needle shield 16.
  • the locking members 80 as shown in Figs. 25 and 26, can be formed by a plurality of legs 162 (e.g., two legs) having a tapered surface 166 terminating in a bottom end 164 of the legs 162 that contact the inclined surface of the projecting member 32 of the hub 12 to bend the plurality of legs 162 from a first configuration, as shown in Fig. 25, to a second configuration such that the plurality of legs 162 can be bent outward to engage the recess of the locking members 80.
  • the components of the hub and outer cover can be injection molded plastic, such as acrylonitrile butadiene styrene (ABS), polypropylene, or the like while the cannula is surgical grade stainless steel.
  • ABS acrylonitrile butadiene styrene
  • the hub assembly may be constructed with the needle separately, with adhesive applied in the interface area to secure the cannula to the hub, and this sub-assembly may then be assembled with an inner shield (optionally, depending on the embodiment), and fit by interference into an outer cover.

Abstract

La présente divulgation concerne un stylo injecteur comprenant un raccord comprenant une extrémité proximale conçue pour être accouplée à un dispositif de distribution et une extrémité distale comprenant une aiguille s'étendant à partir de l'extrémité distale et un boîtier accouplé au raccord et comprenant une extrémité distale ouverte. Un protecteur d'aiguille est reçu dans le boîtier et est mobile entre une première position étendue recouvrant l'aiguille, une position rétractée exposant l'aiguille, et une seconde position étendue de telle sorte que le protecteur d'aiguille se verrouille par rapport au boîtier. Un élément de sollicitation s'étend entre le boîtier et le protecteur d'aiguille pour solliciter le protecteur d'aiguille dans une direction distale par rapport au raccord, l'élément de sollicitation se dilatant lorsque le protecteur d'aiguille se déplace vers la position rétractée et se contracte pour déplacer le protecteur d'aiguille vers la seconde position étendue.
PCT/US2022/033040 2021-06-11 2022-06-10 Ensemble stylo injecteur WO2022261458A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202163209695P 2021-06-11 2021-06-11
US63/209,695 2021-06-11

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WO2022261458A1 true WO2022261458A1 (fr) 2022-12-15

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WO (1) WO2022261458A1 (fr)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5658259A (en) * 1995-10-19 1997-08-19 Meridian Medical Technologies, Inc. Dental cartridge assembly auto-injector with protective needle cover
EP2090326B1 (fr) * 2008-02-13 2013-09-18 ARTSANA S.p.A. Aiguille-stylo d'injection de sécurité avec élément protecteur de l'aiguille
US20160228654A1 (en) * 2013-09-30 2016-08-11 Htl-Strefa Spolka Akcyjna Safety needle device
US20170259009A1 (en) * 2016-03-11 2017-09-14 Arta Plast Ab Safety injection needle device
US20200215272A1 (en) * 2016-12-13 2020-07-09 Becton, Dickinson And Company Safety Needle Device

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5658259A (en) * 1995-10-19 1997-08-19 Meridian Medical Technologies, Inc. Dental cartridge assembly auto-injector with protective needle cover
EP2090326B1 (fr) * 2008-02-13 2013-09-18 ARTSANA S.p.A. Aiguille-stylo d'injection de sécurité avec élément protecteur de l'aiguille
US20160228654A1 (en) * 2013-09-30 2016-08-11 Htl-Strefa Spolka Akcyjna Safety needle device
US20170259009A1 (en) * 2016-03-11 2017-09-14 Arta Plast Ab Safety injection needle device
US20200215272A1 (en) * 2016-12-13 2020-07-09 Becton, Dickinson And Company Safety Needle Device

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