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WO2023164508A2 - Ensemble aiguille stylo avec protection d'aiguille - Google Patents

Ensemble aiguille stylo avec protection d'aiguille Download PDF

Info

Publication number
WO2023164508A2
WO2023164508A2 PCT/US2023/063068 US2023063068W WO2023164508A2 WO 2023164508 A2 WO2023164508 A2 WO 2023164508A2 US 2023063068 W US2023063068 W US 2023063068W WO 2023164508 A2 WO2023164508 A2 WO 2023164508A2
Authority
WO
WIPO (PCT)
Prior art keywords
needle
needle shield
distal
proximal
shield
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/US2023/063068
Other languages
English (en)
Other versions
WO2023164508A3 (fr
Inventor
Kelly Gail DUNCAN
Paul CARSE
William Carr
Sergey Grigoryants
Paul Murray
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Embecta Corp
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 WO2023164508A2 publication Critical patent/WO2023164508A2/fr
Publication of WO2023164508A3 publication Critical patent/WO2023164508A3/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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
    • A61M5/3202—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
    • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/326—Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user
    • 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
    • A61M5/3293—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 characterised by features of the 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
    • A61M5/3205—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
    • 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
    • A61M2005/3254—Shielding of proximal needles, e.g. for pen 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
    • A61M5/178—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
    • A61M5/326—Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user
    • A61M2005/3267—Biased sleeves where the needle is uncovered by insertion of the needle into a patient's body
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/583—Means for facilitating use, e.g. by people with impaired vision by visual feedback

Definitions

  • the present disclosure is directed to medical devices for delivering and/or injecting a medication.
  • the device can be configured for the injection of a medication to a patient.
  • the device can be a pen needle including a needle hub and a distal needle shield with a distal surface where the distal needle shield is retractable during use to expose the needle.
  • a proximal needle shield is included that moves to an extended position after use.
  • the needle hub supports a needle or cannula.
  • the device has a biasing member to bias the distal needle shield in a distal direction relative to the hub.
  • a medication pen for delivering self-administered medications generally includes a pen body, which houses a medication compartment.
  • a separate pen needle can be attached to and detached from the pen body.
  • the pen needle includes a needle hub having a recess on the proximal side for receiving the pen body and a proximal (non-patient end) needle accessing the medication compartment, typically piercing the septum of a medication cartridge in the pen body.
  • the distal patient end of the pen needle includes the needle or cannula that is inserted into the injection site.
  • Injections may be performed in the intradermal (ID) region, the subcutaneous (SC) region and the intramuscular (IM) region.
  • ID intradermal
  • SC subcutaneous
  • IM intramuscular
  • the SC region is preferred for administering an injection.
  • Shorter needles such as 4 mm and 5 mm needles, are adapted to achieve injection to a specified target depth in a subcutaneous region.
  • the needle hub ensures that a needle is inserted to a desired target depth, regardless of the angle at which the user may approach the injection site with the medication pen or delivery device.
  • the cannula is supported in an axially positioned post on the needle hub. The post forms a narrow portion extending distally from the relatively wider portion in which the pen body is received.
  • a distal face of the needle hub placed against the injection site may have a slight taper at the edge. However, the edge of the needle hub engages the skin when the cannula is inserted at an angle, interfering with the injection. The slight taper is not functional during an injection, or is only at the edge of the distal face of the needle hub.
  • the present disclosure relates to a pen needle including: a housing; a needle hub received in the housing, the needle hub having a needle with a proximal end and a distal end, wherein the distal end of the needle extends from a distal end of the housing, wherein the needle hub includes: a distal end wall and one or more openings in the distal end wall of the needle hub; and a side wall and one or more notches in the side wall of the needle hub; a distal needle shield received in the housing and configured to move between an extended position of the distal needle shield to cover the distal end of the needle and a retracted position of the distal needle shield to expose the distal end of the needle; and a proximal needle shield, wherein the proximal needle shield is configured for moving relative to the housing between a retracted position of the proximal needle shield, where a proximal end of the proximal needle shield is positioned within the housing, and an extended position of the proximal needle
  • the present disclosure relates to a pen needle, wherein the proximal needle shield includes: a distal end wall; an inclined surface extending from the distal end wall of the proximal needle shield; and a locking tab extending from the distal end wall of the proximal needle shield for contacting the one or more notches of the needle hub to lock the proximal needle shield in the extended position of the proximal needle shield.
  • the present disclosure relates to a pen needle, wherein the inclined surface and the locking tab project through the one or more openings in the distal end wall of the needle hub when the proximal needle shield is in the retracted position of the proximal needle shield.
  • the present disclosure relates to a pen needle, wherein the distal needle shield includes a locking member for locking the distal needle shield in the extended position of the distal needle shield after use, wherein: the locking member is oriented for contacting the inclined surface of the proximal needle shield to rotate the distal needle shield to an angular position for locking the distal needle shield; and the locking member is received in an opening in the housing to lock the distal needle shield in the extended position of the distal needle shield.
  • the present disclosure relates to a pen needle including: a housing; a biasing member; a needle hub received in the housing, the needle hub having a needle with a proximal end and a distal end, wherein the distal end of the needle extends from a distal end of the housing, the needle hub including an end wall with one or more openings; a distal needle shield received in the housing and configured to move between an extended position of the distal needle shield to cover the distal end of the needle and a retracted position of the distal needle shield to expose the distal end of the needle, the distal needle shield having a side wall with a proximal end including an outwardly projecting flange with recessed areas and one or more locking tabs; and a proximal needle shield received in the needle hub, wherein the proximal needle shield is configured for moving relative to the needle hub between a retracted position of the proximal needle shield and an extended position of the proximal needle shield, the proximal needle
  • the present disclosure relates to a pen needle, wherein the proximal needle shield has a proximal end configured for coupling to a delivery device.
  • the present disclosure relates to a pen needle, wherein the proximal end of the needle can fluidly connect to the delivery device when the proximal needle shield is in the retracted position of the proximal needle shield.
  • the present disclosure relates to a pen needle, wherein the proximal needle shield moves relative to the needle hub between the retracted position of the proximal needle shield and the extended position of the proximal needle shield.
  • the present disclosure relates to a pen needle, wherein the distal needle shield contacts the proximal needle shield when the distal needle shield is moved from the extended position of the distal needle shield to the retracted position of the distal needle shield to rotate the distal needle shield from a first angular position to a second angular position.
  • the present disclosure relates to a pen needle, wherein the distal needle shield contacts an inclined surface of the proximal needle shield to rotate the distal needle shield to the second angular position by axial movement of the distal needle shield.
  • the present disclosure relates to a pen needle, wherein: the distal needle shield includes a locking member; the housing includes a side wall having an opening; the locking member is axially misaligned with the opening of the housing when the distal needle shield is in the first angular position; and the locking member is axially aligned with the opening of the housing when the distal needle shield is in the second angular position.
  • the present disclosure relates to a pen needle, wherein the proximal needle shield includes a locking tab for contacting the needle hub to lock the proximal needle shield in the extended position of the proximal needle shield.
  • the present disclosure relates to a pen needle, wherein the locking tab of the proximal needle shield extends through a distal end of the needle hub when the proximal needle shield is in the retracted position of the proximal needle shield, and wherein the locking tab of the proximal needle shield contacts a surface of a notch of the needle hub to lock the proximal needle shield in the extended position of the proximal needle shield.
  • the present disclosure relates to a pen needle, wherein the distal needle shield contacts an inclined surface of the proximal needle shield when the distal needle shield moves from the extended position of the distal needle shield to the retracted position of the distal needle shield to rotate the distal needle shield to an angular position for locking the distal needle shield after use.
  • the present disclosure relates to a pen needle, wherein the inclined surface projects through one of the one or more openings in the needle hub when the proximal needle shield is in the retracted position of the proximal needle shield.
  • the present disclosure relates to a pen needle, wherein proximal needle shield includes an inclined surface, wherein the inclined surface projects through one of the one or more openings in the needle hub when the proximal needle shield is in the retracted position of the proximal needle shield, and wherein rotation of the proximal needle shield relative to the needle hub contacts the inclined surface with the needle hub to move the proximal needle shield to the extended position of the proximal needle shield.
  • the present disclosure relates to a pen needle, wherein the distal needle shield includes a locking tab for locking the distal needle shield in the extended position of the distal needle shield after use, wherein the locking tab is oriented for contacting an inclined surface of the proximal needle shield to rotate the distal needle shield to an angular position for locking the distal needle shield.
  • the present disclosure relates to a pen needle, wherein the housing includes an opening in a side wall of the housing, and the locking tab of the distal needle shield is received in the opening to lock the distal needle shield in the extended position of the distal needle shield.
  • the present disclosure relates to a pen needle, wherein the pen needle includes a single biasing member extending between the distal needle shield and the needle hub.
  • the present disclosure relates to a pen needle, wherein: the distal needle shield is configured to move from a first extended position of the distal needle shield to cover the distal end of the needle to the retracted position of the distal needle shield to expose the distal end of the needle; the distal needle shield is configured to move from the retracted position of the distal needle shield to a second extended position of the distal needle shield to cover the distal end of the needle; a distal end of the distal needle shield extends a first distance from the housing in the first extended position of the distal needle shield; and the distal end of the distal needle shield extends a second distance from the housing in the second extended position of the distal needle shield, wherein the second distance is greater than the first distance.
  • the present disclosure relates to a pen needle including: a housing having an open proximal end; a needle hub having a needle with a proximal end and a distal end, wherein the needle hub is received in an inner cavity of the housing; a distal needle shield received in the housing and configured to move between an extended position of the distal needle shield to cover the distal end of the needle and a retracted position of the distal needle shield to expose a distal end of the needle; and a proximal needle shield having a proximal end and a distal end, wherein the proximal needle shield is configured for moving relative to the needle hub between a retracted position of the proximal needle shield, where the proximal end of the needle can fluidly connect with a delivery device, and an extended position of the proximal needle shield to inhibit access to the proximal end of the needle, wherein the proximal needle shield includes a projection extending distally of the needle hub for contacting the distal
  • the present disclosure relates to a pen needle, wherein the projection extends through an opening in the needle hub for contacting and rotating the distal needle shield to the second angular position.
  • the present disclosure relates to a pen needle, wherein the projection includes an inclined surface for contacting a proximal end of the distal needle shield.
  • the present disclosure relates to a pen needle, wherein rotation of the proximal needle shield relative to the needle hub causes the inclined surface to contact a surface of the needle hub and move the proximal needle shield to the extended position of the proximal needle shield.
  • the present disclosure relates to a pen needle, wherein the proximal end of the proximal needle shield is configured for coupling to a delivery device.
  • the present disclosure relates to a pen needle, wherein the proximal needle shield includes a locking tab extending from a distal end of the needle hub when the proximal needle shield is in the retracted position of the proximal needle shield, and wherein the locking tab engages an inner surface of the needle hub when the proximal needle shield is in the extended position of the proximal needle shield to lock the proximal needle shield in the extended position of the proximal needle shield.
  • the present disclosure relates to a pen needle, wherein the needle hub includes an opening in a distal end of the needle hub that receives the locking tab and the projection when the proximal needle shield is in the retracted position of the proximal needle shield.
  • the present disclosure relates to a pen needle, wherein when the locking tab of the proximal needle shield, when withdrawn from the opening in the needle hub, is configured to spring to a position to contact the needle hub to prevent movement of the proximal needle shield relative to the needle hub.
  • the present disclosure relates to a method of dispensing fluid including: coupling a pen needle to a delivery device, the pen needle including a housing, a needle hub having a needle, a distal needle shield, and a proximal needle shield; moving the distal needle shield from a first extended position of the distal needle shield to a retracted position of the distal needle shield to expose a distal tip of the needle, wherein moving to the retracted position of the distal needle shield contacts the distal needle shield with the proximal needle shield to rotate the distal needle shield from a first angular position to a second angular position; dispensing the fluid from the needle; moving the distal needle shield distally to lock the distal needle shield in a second extended position of the distal needle shield to cover the distal tip of the needle; and moving the proximal needle shield proximally to an extended position of the proximal needle shield where the proximal needle shield extends from the housing to shield a proximal tip
  • the present disclosure relates to a method, wherein the distal needle shield is moved linearly in an axial direction from the retracted position of the distal needle shield to the second extended position of the distal needle shield to lock the distal needle shield in the second extended position of the distal needle shield.
  • the present disclosure relates to a method, wherein the proximal needle shield includes a projection extending from the needle hub when the proximal needle shield is in a retracted position of the proximal needle shield, and wherein the distal needle shield contacts the projection when moved to the retracted position of the distal needle shield to rotate the distal needle shield to the second angular position.
  • the present disclosure relates to a method, wherein the projection of the proximal needle shield includes an inclined surface to engage the distal needle shield when the distal needle shield is moved to the retracted position of the distal needle shield, and wherein the inclined surface contacts the needle hub to move the proximal needle shield in a proximal direction to the extended position of the proximal needle shield by rotation of the proximal needle shield relative to the needle hub.
  • the present disclosure relates to a method, wherein the proximal needle shield includes a locking tab for engaging an inner surface of the needle hub to lock the proximal needle shield in the extended position of the proximal needle shield.
  • the present disclosure relates to an injection system, including: a delivery device including a supply of medication; and the pen needle of any one of the previous embodiments.
  • Fig. 1 is a side view a pen needle and outer cover according to some embodiments
  • Fig. 2 is a perspective view in partial cross section of a pen needle according to some embodiments.
  • Fig. 3 is a cross sectional view of a pen needle according to some embodiments;
  • Fig. 4 is a cross sectional view of the pen needle and outer cover according to some embodiments;
  • Fig. 5 is a perspective cross sectional view of the pen needle and outer cover according to some embodiments.
  • Fig. 6 is a side view of the needle hub according to some embodiments.
  • Fig. 7 is a perspective view of the needle hub according to some embodiments.
  • Fig. 8 is a cross sectional view of the needle hub according to some embodiments.
  • Fig. 9 is a side view of the proximal needle shield according to some embodiments.
  • Fig. 10 is a perspective view of the proximal needle shield according to some embodiments.
  • Fig. 11 is a cross sectional view of the proximal needle shield according to some embodiments.
  • Fig. 12 is a side view of the distal needle shield according to some embodiments.
  • Fig. 13 is perspective view of the distal needle shield according to some embodiments.
  • Fig. 14 is cross sectional view of the distal needle shield according to some embodiments.
  • Fig. 15 is a partial cross sectional view of the pen needle pre-use, according to some embodiments.
  • Fig. 16 is a partial cross sectional view of the pen needle during use, according to some embodiments.
  • Fig. 17 is a partial cross sectional view of the pen needle after use, according to some embodiments.
  • Fig. 18 is a sectional view of the internal threads of the proximal needle shield, according to some embodiments.
  • Fig. 19 is an exploded view of an exemplary delivery device according to some embodiments.
  • FIG. 19 is an exploded view of an exemplary delivery device according to some embodiments.
  • a delivery pen or delivery device is used herein to refer to a device having a medication compartment, typically containing multiple doses of medication that can be attached to a separate pen needle.
  • the “pen needle” refers to a needle-bearing assembly which can be attached to the medication pen body so that a proximal end of the pen needle assembly accesses a medication compartment and a distal end is adapted for insertion into an injection site to perform one or more injections.
  • needle and “cannula” are used herein interchangeably to refer to a hollow tubular member having a lumen and a sharpened end for insertion into an injection site on a subject.
  • distal direction is in the direction toward the injection site, and the “proximal” direction is the opposite direction.
  • Axial means along or parallel to the longitudinal axis of the needle and the “radial” direction is a direction perpendicular to the axial direction.
  • connection and “coupled” and variations thereof are not limited to physical or mechanical connections or couplings.
  • terms such as up, down, bottom, and top are relative, and are to aid illustration, but are not limiting.
  • the embodiments are not intended to be mutually exclusive so that the features of one embodiment can be combined with other embodiments as long as they do not contradict each other.
  • Terms of degree, such as “substantially”, “about” and “approximately” are understood by those skilled in the art to refer to reasonable ranges around and including the given value and ranges outside the given value, for example, general tolerances associated with manufacturing, assembly, and use of the embodiments.
  • the term “substantially” when referring to a structure or characteristic includes the characteristic that is mostly or entirely present in the structure.
  • the present disclosure is directed to a medical device such as an injection device.
  • the injection device can be a pen needle assembly for coupling to an injection pen or other delivery device.
  • the pen needle has a needle or cannula extending from a distal end of the pen needle with a movable shield covering the needle or cannula that can be retracted to expose the distal end of the needle or cannula for introducing the medication to the patient.
  • the needle or cannula can have a proximal end for piercing a septum on the injection pen where the proximal end is covered by the needle hub.
  • the pen needle assembly includes a housing, needle hub, a distal needle shield covering at least a portion of the needle and a proximal needle shield.
  • the distal needle shield moves and/or slides relative to the housing and the needle hub between a retracted position to expose the needle and an extended position covering the distal end of the needle.
  • the pen needle assembly can have a biasing member that contacts a surface of the distal needle shield to bias the shield in a distal direction.
  • the proximal needle shield moves relative to the housing and needle hub to cover or block access to the proximal end of the needle after use.
  • the pen needle has a needle hub with a needle or cannula and a housing receiving the needle hub where the needle hub is in a fixed position relative to the housing.
  • a distal needle shield and a proximal needle shield move relative to the needle hub and the housing to cover the respective ends of the needle.
  • a spring member contacts a distal face of the needle hub and a proximal surface of the distal needle shield to bias the distal needle shield in a distal direction.
  • the proximal needle shield is received in the housing and is movable relative to the needle hub to cover or block access to the proximal end of the needle after use. In some embodiments, the proximal needle shield is received in the cavity of the needle hub and is movable within the needle hub.
  • the pen needle can include a housing, a needle hub and a proximal needle shield where the proximal needle shield has an open proximal end that is configured for coupling directly to a delivery device.
  • the proximal needle shield is movable from a retracted position to an extended position to cover the proximal end of the needle after use.
  • the proximal needle shield is moved to the extended position to cover the end of the needle by the rotational movement of the proximal needle shield when the pen needle is separated from the delivery device.
  • the proximal needle shield can have a cam surface that contacts the needle hub so that rotation of the proximal needle shield moves the proximal needle shield to the extended position.
  • the cam surface of the proximal needle shield can be configured to engage a distal needle shield to rotate the distal needle shield when moved to a retracted position.
  • the distal needle shield is movable axially and rotationally relative to the housing by movement from an extended position to a retracted position.
  • the distal needle shield can be movable to an extended distal position to a locked position.
  • the proximal needle shield can be moved axially from a retracted position to an extended position when disconnected from the delivery device.
  • a spring member between the needle shield and the needle hub allows the needle shield to be retracted relative to the needle hub and the housing to expose the needle.
  • the needle shield can be moved distally by the spring member to a locked position to cover the needle after use.
  • the features of the pen needle can be attained by providing a pen needle having a housing, a needle hub, a distal needle shield and a proximal needle shield.
  • the needle hub supports a needle and is positioned in the housing.
  • the needle has a distal end projecting from a distal end of the housing.
  • the distal needle shield is received in the housing and is configured to move between a distal position covering the distal end of the needle and retracted position to expose the distal end of the needle.
  • the proximal needle shield has a proximal end configured for coupling to a delivery device and for moving relative to the needle hub between a retracted position where a proximal end of the needle can communicate with a delivery device and an extended position to cover the proximal end of the needle.
  • the features of the pen needle are also attained by providing pen needle that includes a housing having an open distal end, a needle hub received in a proximal end of the housing, a distal needle shield and a proximal needle shield.
  • the needle hub supports a needle and is received in the housing.
  • the needle has a distal end and a proximal end.
  • the distal needle shield is received in the housing and is configured to move between a distal position to cover the distal end of the needle and a retracted position to expose a distal end of the needle.
  • the proximal needle shield is movable relative to the needle hub between a retracted position where a proximal end of the needle is accessible and an extended position to cover the proximal end of the needle.
  • the proximal needle shield has a projection extending distally of the needle hub for contacting the distal needle shield when the distal needle shield is moved from the distal position to the retracted position and to rotate the distal needle shield from a first angular position to a second angular position where the distal needle shield locks when moved from the retracted position to the distal position.
  • the features are also provided by a method of dispensing a fluid comprising coupling a pen needle to a delivery device where the pen needle has a housing, a needle coupled to a needle hub, a distal needle shield and a proximal needle shield.
  • the proximal needle shield is coupled to the delivery device.
  • the distal needle shield is retracted to expose the needle where the distal needle shield contacts the proximal needle shield to rotate the distal needle shield to a position for locking when the distal needle shield moves to the distal position.
  • the delivery device dispenses the medication and is separated from the proximal needle shield, which rotates and moves the proximal needle shield to an extended position.
  • the pen needle in various embodiments can have a convex distal axial surface for shaping the axial face of the distal needle shield and shape the indentation of the surface of the skin during needle insertion and drug delivery.
  • the needle hub can have an axial face with a surface area of about 5-50 nun 2 .
  • the surface of the axial face in one embodiment can have a convex configuration with a height of about of 0.3 to 0.7 mm and a surface area of 1-4 mm 2 .
  • the delivery device is a pen needle delivery device or injector pen, which typically comprises a dose knob/button, a body and a cap.
  • the body can include a threaded end for coupling with a pen needle.
  • a dose knob/button can allow a user to set the dosage of medication to be injected.
  • the body can be gripped by the user when injecting medication.
  • the cap can be used by the user to securely hold the pen needle device in a shirt pocket or other suitable location and provide cover/protection from accidental needle injury.
  • a medicament cartridge is typically attached to a standard pen injector housing by a known attachment mechanism.
  • the distal movement of a plunger or stopper within the medicament cartridge causes medication to be forced into the reservoir housing.
  • the medicament cartridge is sealed by a septum and punctured by a septum penetrating needle cannula located within a reservoir or housing.
  • the reservoir housing can be screwed onto the medicament cartridge although, other attachment mechanism can be used.
  • the pen needle delivery device can be a standard pen delivery device known in the industry so that the pen needle delivery device is not shown in detail.
  • the cannula of the pen needle can be a double-ended cannula beveled and/or sharpened at both ends for coupling to the delivery device and for penetrating the skin of the patient.
  • the cannula has a lumen with a diameter sufficient to inject the medication into the patient.
  • a delivery device 200 is depicted according to some embodiments.
  • the delivery device 200 may be disposable.
  • the delivery device 200 may include an outer sleeve 213.
  • the outer sleeve 213 may contain at least some of the driving mechanisms of the delivery device 200 within.
  • the outer sleeve 213 may contain medication supply to be administered to a patient.
  • the outer sleeve 213 may provide a gripping surface for a user to grip when administering medication to a patient.
  • the delivery device 200 includes a dose knob 224 positioned at a proximal end 231 of the outer sleeve 213.
  • the dose knob 224 may be rotatable with respect to the outer sleeve 213 of the delivery device 200.
  • the user may rotate the dose knob 224 to selectively set a desired volume of a dose of medication to be injected to a patient.
  • rotation of the dose knob 224 in a first direction may axially translate the dose knob 224 away from the proximal end 231 of the outer sleeve 213, thereby increasing the volume of a dose of medication to be administered with the delivery device 200.
  • rotation of the dose knob 224 in a second direction may axially translate the dose knob 224 toward the proximal end 231 of the outer sleeve 213, thereby decreasing the volume of a dose of medication to be administered with the delivery device 200.
  • a button 240 may be coupled to a proximal end of the dose knob 224. A user may apply an axial force to the button 240 to depress the button 240 and dose knob 224 axially toward the proximal end 231 of the outer sleeve 213, thereby activating the driving mechanism to administer a dose of medication from the delivery device 200.
  • the driving and delivery mechanisms of the delivery device 200 should be understood by a person having ordinary skill in the art and are, therefore, not discussed in detail herein.
  • depression of the button 240 and dose knob 224 in the distal direction injects the dosed medication via a lead screw 207 and a plunger 215 through a medicament cartridge 212, which is attached to the delivery device 200 through a lower housing 217.
  • the distal movement of the plunger 215 within the medicament cartridge 212 causes medication to be forced into a needle 14 (Fig. 3) of the pen needle 10 (Fig. 3).
  • the medicament cartridge 212 may be sealed by a septum 216, which may be punctured by the needle 14 (Fig. 3) located within the pen needle 10 (Fig. 3).
  • the pen needle 10 (Fig. 3) can be screwed onto the lower housing 217, although other attachment means may be used. It should be appreciated that the foregoing description is merely one representative example of the delivery device 200, and other designs for the delivery device 200 are contemplated herein.
  • FIG. 1 is a side view a pen needle and outer cover according to some embodiments.
  • Fig. 2 is a perspective view in partial cross section of a pen needle according to some embodiments.
  • Fig. 3 is a cross sectional view of a pen needle according to some embodiments.
  • Fig. 4 is a cross sectional view of the pen needle and outer cover according to some embodiments.
  • Fig. 5 is a perspective cross sectional view of the pen needle and outer cover according to some embodiments.
  • Fig. 6 is a side view of the needle hub according to some embodiments.
  • Fig. 7 is a perspective view of the needle hub according to some embodiments.
  • Fig. 1 is a side view a pen needle and outer cover according to some embodiments.
  • Fig. 3 is a cross sectional view of a pen needle according to some embodiments.
  • Fig. 4 is a cross sectional view of the pen needle and outer cover according to some embodiments.
  • Fig. 5 is a perspective cross sectional view
  • Fig. 8 is a cross sectional view of the needle hub according to some embodiments.
  • Fig. 9 is a side view of the proximal needle shield according to some embodiments.
  • Fig. 10 is a perspective view of the proximal needle shield according to some embodiments.
  • Fig. 11 is a cross sectional view of the proximal needle shield according to some embodiments.
  • Fig. 12 is a side view of the distal needle shield according to some embodiments.
  • Fig. 13 is perspective view of the distal needle shield according to some embodiments.
  • Fig. 14 is cross sectional view of the distal needle shield according to some embodiments.
  • Fig. 15 is a partial cross sectional view of the pen needle pre-use, according to some embodiments.
  • Fig. 16 is a partial cross sectional view of the pen needle during use, according to some embodiments.
  • Fig. 17 is a partial cross sectional view of the pen needle after use, according to some embodiments.
  • Fig. 18 is a sectional view of the internal threads of the proximal needle shield, according to some embodiments.
  • the pen needle 10 includes a needle hub 12 having a needle 14.
  • the needle 14 includes a distal end, or distal tip, and a proximal end, or proximal tip.
  • the pen needle 10 includes a housing 18.
  • the pen needle 10 can include a distal needle shield 16.
  • the distal needle shield 16 can be, at least partially, received in the housing 18.
  • the distal needle shield 16 and the housing 18, together, can form a shell of the pen needle 10.
  • the pen needle 10 can include a proximal needle shield 20.
  • the distal needle shield 16 and the proximal needle shield 20 are configured to move and/or slide relative to the housing 18 during use. In some embodiments, the distal needle shield 16 and the proximal needle shield 20 are configured to move and/or slide relative to the needle hub 12 during use.
  • the distal needle shield 16 is configured to cover the distal end of the needle 14 and can be referred to as a patient end needle shield.
  • the proximal needle shield 20 is configured to cover or inhibit access to the proximal end of the needle 14 and can be referred to as a non-patient end needle shield.
  • inhibiting access to the proximal end of the needle 14 can include blocking the proximal end of the needle 14 such that the proximal end of the needle 14 cannot be accessed by a user. In some embodiments, inhibiting access to the proximal end of the needle 14 can include partially blocking the proximal end of the needle 14 such that the proximal end of the needle 14 is difficult to access by a user. In some embodiments, inhibiting access to the proximal end of the needle 14 can include positioning the proximal needle shield 20 such that the proximal end of the needle 14 cannot be brought into fluid communication with a delivery device (e.g. with a medication compartment of the delivery device).
  • the components of the pen needle 10 can be made of a suitable plastic material.
  • the distal needle shield 16 is made of a transparent plastic material to enable visualizing the needle 14 within the pen needle 10.
  • the distal end of the needle 14 projects in a distal direction from the needle hub 12 with a length for injecting a medication into a patient.
  • the proximal end of the needle 14 has a proximal end projecting into an inner cavity of the needle hub 12 and an inner cavity of the proximal needle shield 20 for piercing a septum of the delivery device.
  • the proximal end of the needle 14 is oriented within the open end of the needle hub 12 and can be spaced a distance from the proximal end of the needle hub 12 to inhibit inadvertent needle stick.
  • the proximal end of the proximal shield 20 is open to receive and couple to a delivery device.
  • the pen needle 10 is initially enclosed in an outer cover 22 having a removable seal 24 to retain the pen needle 10 in a clean and sterile state during shipping and prior to use.
  • the seal 24 is removed and the pen needle 10 is attached to a delivery device, such as an injection pen as known in the art.
  • the outer cover 22 has an inner dimension to receive the pen needle 10.
  • the outer surface of the outer cover 22 can include ribs 26 or other gripping surfaces to assist the user in connecting the pen needle 10 to the delivery device after the seal 24 is removed from the outer cover 22.
  • the open bottom end of the outer cover 22 has a radially extending flange 28 for supporting the seal 24.
  • the housing 18 has a distal end with a distal opening 30 and a proximal end with a proximal opening 32.
  • the distal opening 30 has a dimension to receive the distal needle shield 16.
  • the distal opening 30 is sized such that the distal needle shield 16 can move axially within the distal opening 30 between an extended position shown in Fig. 2-5, 15, and 17 and a retracted position shown in Fig. 16.
  • the distal needle shield 16 can move axially within the distal opening 30 from a first extended position (e.g.
  • the distal needle shield 16 can move axially from the retracted position to a second extended position (e.g. a post-use extended position) shown in Fig. 17.
  • the distal end of the distal needle shield 16 can extend a greater distance from the distal opening 30 of the housing 18 in the second extended position than in the first extended position.
  • the housing 18 has a side wall 34 with an internal dimension to receive the needle hub 12. As shown in Fig. 2, in some embodiments, the inner surface of the side wall 34 has a coupling feature for mating with the needle hub 12.
  • the coupling is a recess 36 around the circumference of the inner surface toward the proximal opening 32.
  • the distal end of the side wall 34 includes one or more windows, shown as openings 39 (Fig. 17) for providing visual indication of the position (e.g. locked or unlocked) of the distal needle shield 16.
  • the needle hub 12 supports the needle 14.
  • the needle 14 can be attached to the needle hub 12 by any suitable mechanism, such as by an adhesive.
  • the needle hub 12 has a side wall 38 with an outer surface complementing the inner surface of the side wall 34 of the housing 18 and forming an internal cavity with a dimension for receiving the proximal needle shield 20.
  • the side wall 38 has a substantially cylindrical configuration with a distal end 40 and a proximal end 42.
  • the proximal end 42 has an outwardly projecting annular rib 44 configured for mating with the recess 36 on the inner surface of the side wall 34 of the housing 18 for coupling the needle hub 12 to the housing 18.
  • the inner surface of the side wall 38 of the needle hub 12 has a radially inward extending rib 46 at or near the proximal end 42 of the side wall 38.
  • the side wall 38 has one or more openings or notches 48 in the side wall 38 of the needle hub 12. In some embodiments, the one or more notches 48 extend from the proximal end 42 of the side wall 38 toward the distal end 40.
  • the outer surface of the side wall 38 of the needle hub 12 has recesses 49 on opposite sides of the needle hub 12.
  • the recesses 49 are formed at the distal end 40 of the needle hub and extend toward the proximal end 42 of the side wall 38.
  • the recesses 49 cooperate with corresponding radially inward extending ribs 149 (Fig. 2) on the inner surface of the side wall 34 of the housing 18 to limit or prevent rotation of the needle hub 12 relative to the housing 18.
  • the needle hub 12 includes a distal end wall 50 with a distally facing surface.
  • one or more openings 52 are provided in the end wall 50.
  • the one or more openings 52 have an arcuate shape extending around at least a portion of the circumference of the end wall 50 and spaced radially inward from the peripheral edges of the needle hub 12.
  • a tower 54 extends from the end wall 50 for supporting the needle 14.
  • the tower 54 has a side wall 56 spaced radially inward from the outer peripheral edge of the end wall 50.
  • the tower 54 projects toward the distal end of the pen needle 10.
  • the side wall 56 of the tower 54 has a substantially cylindrical shape with an outer surface, an inner surface and a distal end wall 58.
  • the end wall 58 has an inner surface with a post 60 extending proximally from the inner surface and an outer distal surface 62.
  • the distal surface 62 has a well 65 for receiving an adhesive to fix the needle 14 to the needle hub.
  • the post 60 has an axial length sufficient to support the needle 14 to resist bending of the needle 14 when the needle 14 pierces the septum of the delivery device.
  • the distal surface 62 of the end wall 58 has a raised inner ring 64 surrounding the well 65 so that the distal surface 62 has a convex curvature.
  • the proximal needle shield 20 is configured to be received in the cavity of the needle hub 12.
  • the proximal needle shield 20 is movable relative to the needle hub 12 between a retracted position and an extended position.
  • the proximal needle shield 20 has an outer dimension and configuration to fit within the cavity of the needle hub 12.
  • the proximal needle shield 20 has a side wall 66 with an open proximal end 68 and distal end 70.
  • a flange 72 projects radially outward from the proximal end of the side wall 66 of the proximal needle shield 20 to guide the proximal needle shield 20 in the open proximal end 42 of the needle hub 12.
  • the side wall 66 of the proximal needle shield 20 has an inner surface with threads 73 for coupling with a threaded end of the delivery device.
  • the end wall 74 is provided at the distal end 70 of the side wall 66 of the proximal needle shield 20.
  • a central opening 76 is provided in the end wall 74.
  • the central opening 76 is surrounded by a collar 78 projecting in the distal direction from the end wall 74 and projecting in the proximal direction from the end wall 74.
  • the opening 76 has dimensions to allow the proximal end of the needle 14 to pass therethrough so that the proximal needle shield 20 can move axially with respect to the needle hub 12 and the housing 18. In some embodiments, the opening 76 has a dimension to receive the post 60.
  • one or more projections 80 extend distally from the end wall 74 of the proximal needle shield 20. In some embodiments, two projections 80 are provided on opposite sides of the end wall 74. In some embodiments, the projections 80 have a curved shape corresponding to the curvature of the side wall 66 of the needle hub 12. In some embodiments, the projections 80 have a curved shape corresponding to a curvature of the openings 52 (Figs. 7 and 8) of the needle hub 12. In some embodiments, the projections 80 have an axial length to extend distally of the needle hub 12 through the openings 52 (Figs. 7 and 8) of the needle hub 12 to engage the distal needle shield 16 during use.
  • the projections 80 extend radially outward of the side wall 66 forming a proximally facing ledge 71.
  • the projections 80 have an inclined surface 82.
  • the inclined surface 82 may be referred to as a cam surface.
  • the proximal needle shield 20 includes one or more locking tabs 84 extending distally from the end wall 74.
  • the locking tabs 84 are flexible.
  • the locking tabs 84 and oriented between the projections 80.
  • the locking tabs 84 extend radially outwardly from the end wall 74 at an angle relative the longitudinal axis of the proximal needle shield 20.
  • the locking tabs 84 have a distal end surface 86 and side surfaces 87. In some embodiments, the distal end surface 86 and/or the side surfaces 87 of the locking tabs 84 engage a surface of the needle hub 12 for locking the proximal needle shield 20 in an extended position of the proximal needle shield 20. In some embodiments, the distal end surface 86 and/or the side surfaces 87 of the locking tabs 84 engage an edge of the notches 48 of the needle hub 12 for locking the proximal needle shield 20 in an extended position of the proximal needle shield 20. In some embodiments, the locking tabs 84 engage the inwardly extending ribs 46 (Fig. 8) of the needle hub 12 for locking the proximal needle shield 20 in the extended position.
  • the ledge 71 engages the inwardly extending ribs 46 (Fig. 8) for locking the proximal needle shield 20 in the extended position.
  • the proximal needle shield 20 includes a crush rib 77 positioned in the internal threads 73 that increases friction between the proximal needle shield 20 and a delivery device coupled to the proximal needle shield 20 via the threads 73.
  • the distal needle shield 16 has a shape and configuration to move relative to the housing 18 between an extended position of the distal needle shield 16 and a retracted position of the distal needle shield 16.
  • the distal needle shield 16 has a shape and configuration to move relative to the needle hub 12 between an extended position of the distal needle shield 16 and a retracted position of the distal needle shield 16.
  • the distal needle shield 16 has a side wall 88 with an open proximal end 90 and a distal end wall 92.
  • the distal end wall 92 has an opening 94 to allow the needle 14 to pass therethrough during the retracting movement of the distal needle shield 16 in the proximal direction to expose a portion of the needle 14 sufficient to pierce and penetrate the skin of the patient as predetermined depth.
  • the end wall 92 has a distally outer surface forming a skin contact surface of the pen needle 10 during an injection.
  • the end wall 92 has an outer raised ring 96 and an inner raised ring 98 forming an annular recess 100 therebetween.
  • the inner ring 98 is positioned distally of the outer ring 96 to define a substantially convex skin contact surface to control the deformation of the skin surface and depth of penetration of the distal end of the needle 14.
  • the proximal end of the side wall 88 has an outwardly projection flange 102.
  • the flange 102 includes recessed areas 104 on opposite sides of the distal needle shield 16.
  • the outer diameter of the flange 102 interacts with a radially inward extending rib 19 of the housing 18 to retain the distal needle shield 16 in the first (e.g. preuse) extended position.
  • the recessed areas 104 can be aligned with and pass over the radially inward extending rib 19 of the housing 18 to allow the distal needle shield 16 to advance to the second (e.g. post-use) extended position.
  • the distal needle shield 16 includes one or more locking tabs 106.
  • the one or more locking tabs 106 are provided on opposite sides of the distal needle shield 16.
  • the one or more locking tabs 106 extend in a proximal direction from the flange 102.
  • the locking tabs 106 have an end face 108 facing in the proximal direction, an inclined radial outer face 110 and a substantially flat radially inner face 112.
  • the locking tabs 106 have a recess 114 formed in the inclined face 110.
  • a biasing member 118 is provided in the housing 18 to bias the distal needle shield 16 in a distal direction with respect to the housing 18 and the needle hub 12.
  • the biasing member 118 is a spring.
  • the biasing member 118 can be a coil or torsion spring having a proximal end contacting the needle hub 12 and a distal end contacting the distal needle shield 16.
  • the biasing member 118 can extend between the end wall 50 (Fig. 7) of the needle hub 12 and the proximal surface of the flange 102 (Fig. 12) of the distal needle shield 16.
  • the proximal end of the biasing member 118 can be positioned on the end wall 50 (Fig. 7) of the needle hub 12 radially inward of the openings 52 (Fig. 7) of the needle hub 12.
  • the pen needle 10 is assembled as shown in Figs. 2-5, 15, and 16.
  • the needle hub 12 is provided in the cavity of the housing 18 where the rib 44 (Fig. 6) of the needle hub 12 snaps into the recess 36 of the housing 18 to retain the needle hub 12 in a fixed position relative to the housing 18.
  • the ribs 149 of the housing 18 are positioned within the recesses 49 (Fig. 7) of the needle hub 12 to retain the needle hub fixed rotationally relative to the housing 18.
  • the proximal needle shield 20 fits within the cavity of the needle hub 12 where the projections 80 and locking tabs 84 extend, and project distally, through the opening 52 in the end wall 50 of the needle hub 12.
  • the distal needle shield 16 is received in the housing 18 where the distal end of the distal needle shield 16 projects through the open distal end 30 of the housing 18.
  • the penneedle lO is depicted in a ready, or pre-use, position inFigs. 2, 3, and 15.
  • the distal needle shield 16 In the ready position of the pen needle 10, the distal needle shield 16 is in the extended position of the distal needle shield 16 to cover the distal tip of the needle 14.
  • the biasing member 118 can provide a distal biasing force on the distal needle shield 16 to maintain the distal needle shield 16 in the extended position of the distal needle shield 16.
  • the distal needle shield 16 In the extended position, the distal needle shield 16 extends distally beyond the housing 18 and covers the distal end of the needle 14 to prevent inadvertent needle pricks with the distal end of the needle 14.
  • the distal needle shield 16 in the ready position, is in the first extended position, where the distal needle shield 16 extends a first distance beyond the housing 18.
  • the outer dimension of the flange 102 (Fig. 13) can be aligned with and contact the retention rib 19 extending inward from the housing 18 to limit the distal advancement of the distal needle shield under the biasing force of the biasing member and maintain the distal needle shield 16 in the first extended position pre-use.
  • the proximal needle shield 20 is in the retracted position of the proximal needle shield 20.
  • the proximal needle shield 20 is positioned within the needle hub 12 and the housing 18 such that the proximal end 68 of the proximal needle shield 20 does not extend proximally beyond the proximal end 42 of the needle hub 12 and the proximal opening 32 of the housing 18.
  • the proximal end of the needle 14 is positioned within the cavity of the proximal needle shield 20 ready to fluidly connect to a delivery device.
  • the proximal needle shield 20 is maintained in the retracted position, at least in part, by frictional forces between the collar 78 of the proximal needle shield 20 and the post 60 of the needle hub 12 positioned within the collar 78. In some embodiments, the proximal needle shield 20 is maintained in the retracted position, at least in part, due to contact forces between the locking tabs 84 of the proximal needle shield 20 and the end wall 50 (Fig. 8) of the needle hub 12. Particularly, with the locking tabs extending distally through the openings 52 (Fig.
  • the radially outward bend of the locking tabs 84 can prevent the locking tabs 84 from sliding axially through the openings 52 in a proximal direction, and therefore prevent the proximal needle shield 20 from moving axially in the proximal direction to the extended position of the proximal needle shield 20.
  • the proximal needle shield 20 is maintained in the retracted position, at least in part, by contact forces between the locking tab 106 (Fig. 12) of the distal needle shield 16 and the projections 80. Particularly, with the distal needle shield 16 in the first extended position of the distal needle shield 16, the locking tabs 106 (Fig.
  • the distal needle shield 16 can be aligned with the distal ends of the projections 80 to contact the projections 80 and prevent inadvertent rotation of the proximal needle shield 20. Still referring to the pen needle 10 in the ready position, the locking tabs 106 (Fig. 12) of the distal needle shield 16 are axially aligned with the inclined surfaces 82 (Fig. 10) of the projections 80 (Fig. 10).
  • a delivery device 200 such as an injection pen, is connected to the pen needle 10.
  • the delivery device 200 can be connected to the proximal end of the pen needle 10.
  • the internal threads 73 (Fig. 11) of the proximal needle shield 20 are threaded onto a threaded end of the delivery device 200 as shown in Fig. 16.
  • the pen needle 10, and particularly the end wall 92 of the distal needle shield 16 is pressed against the skin of the patient to move the distal needle shield 16 proximally from the extended position of the distal needle shield 16 shown in Fig. 15 to the retracted position of the distal needle shield 16 shown in Fig.
  • the contact force between the distal needle shield 16 and the skin of the patient overcomes the distal biasing force of the biasing member 118 to move the distal needle shield 16 proximally into the retracted position of the distal needle shield 16.
  • the proximal movement of the distal needle shield 16 into the retracted position of the distal needle shield 16 causes the proximal end of the locking tabs 106 to contact the inclined surfaces 82 of the projections 80 to rotate the distal needle shield 16 relative to the needle hub 12 and housing 18.
  • axial movement of the distal needle shield 16 in the proximal direction causes the locking tabs 106 to contact the distal ends of the inclined surfaces 82 of the projections 80.
  • Further proximal movement of the distal needle shield 16 causes the locking tabs 106 to ride the inclined surfaces 82 proximally toward the end wall 50 of the needle hub 12. Therefore, proximal movement of the distal needle shield 16 from the extended position of the distal needle shield 16, shown in Fig.
  • the needle 14 is then withdrawn from the patient and the pen needle 10 enters the after-use configuration shown in Fig. 17.
  • the distal biasing force from the biasing member 118 moves the distal needle shield 16 axially in the distal direction to the extended position of the distal needle shield 16.
  • the recessed areas 104 (Fig. 13) of the flange 102 (Fig. 13) are aligned with the retention rib 19 (Fig.
  • the locking tabs 106 of the distal needle shield 16 snap or spring outwardly into the openings 39 of the housing 18 when the distal needle shield 16 moves from the retracted position of the distal needle shield 16 to the extended position of the distal needle shield 16. Interaction between the locking tabs 106 and the openings 39 can lock the distal needle shield 16 in the distal position of the distal needle shield 16 to prevent further use of the pen needle 10.
  • the locking tabs 106 When the locking tabs 106 are engaged with the openings 39, the locking tabs 106 are visible to a user through the openings 39 to provide a visual indication to the user that the pen needle 10 has been used and locked so that the pen needle 10 cannot be re-used.
  • the distal needle shield 16 When the distal needle shield 16 is in the second extended position, extending further distally outward than in the first extended position, a user can visually recognize the distal position of the distal needle shield 16 and determine that the pen needle 10 cannot be re-used.
  • the pen needle 10 is separated from the delivery device 200 by rotation of the delivery device 200 relative to the pen needle 10.
  • the friction between the delivery device 200 and the proximal needle shield 20 rotates the proximal needle shield 20 relative to the needle hub 12.
  • the friction between the delivery device 200 and the proximal needle shield 20 can overcome the friction forces between the collar 78 (Fig. 3) and the post 60 (Fig. 3) to move the proximal needle shield from the retracted position of the proximal needle shield 20.
  • the locking tabs 106 (Fig. 12) of the distal needle shield 16 no longer contact the projections 80 to restrict the rotation of the proximal needle shield 20.
  • the rotation of the proximal needle shield 20 causes the inclined surfaces 82 of the projections 80 to contact the end surfaces or edges of the opening 52, which moves the proximal needle shield 20 axially in a proximal direction.
  • the end surfaces of the openings 52 can contact the entire length of the inclined surfaces 82 of the projections 80 to direct the projections 80 proximally such that the projections 80 no longer extend distally from the openings 52 of the needle hub 12.
  • the simultaneous proximal movement and rotation of the proximal needle shield 20 can also direct the locking tabs 84 through the openings 52 of the needle hub 12.
  • proximal movement of the proximal needle shield 20 from the retracted position of the proximal needle shield 20 (shown in Figs. 15 and 16) to the extended position of the proximal needle shield 20 (shown in Fig. 17) coincides with movement of the proximal needle shield 20 from a first angular position to a second angular position.
  • the locking tabs 84 can be axially misaligned with the notches 48 (Fig. 7) of the needle hub 12.
  • the locking tabs 84 can be axially aligned with the notches 48.
  • the locking tabs 84 can move proximally through the openings 52 of the proximal needle shield 20 and contact an inner surface of the side wall 38 and flex radially inward.
  • one or more locking tabs 84 can be aligned with the notches 48 such that the locking tabs 84 deflect radially outward through the notches 48.
  • One or more surfaces of the locking tabs 84 therefore contacts the edges of the notches 48, such that the forces between the notches 48 and locking tabs 84 lock the proximal needle shield 20 in the extended position of the proximal needle shield 20 (e.g. prevent further rotational and axial movement of the proximal needle shield 20 and maintain connection between the proximal needle shield 20 and the needle hub 12).
  • one or more locking tabs 84 in the second angular position, can deflect radially outward to contact the inward extending rib 46 (Fig. 8) of the needle hub 12 to prevent further proximal axial movement of the proximal needle shield 20 beyond the extended position of the proximal needle shield 20 (i.e.
  • the proximally facing ledge 71 of the proximal needle shield 20 can contact the inward extending rib 46 (Fig. 8) to prevent to prevent further proximal axial movement of the proximal needle shield 20 beyond the extended position of the proximal needle shield 20 (i.e. to maintain connection between the proximal needle shield 20 and the needle hub 12).
  • the proximal end 68 of the proximal needle shield 20 extends proximally beyond the proximal end 32 of the housing 18 and the proximal end 42 of the needle hub 12.
  • the proximal needle shield 20 covers the proximal end of the needle 14 to inhibit user access to the proximal end of the needle 14 to prevent accidental needle pricks with the proximal end of the needle 14. Due to the relative positions of the threads 73 of the proximal needle shield 20 and the proximal end of the needle 14 when the proximal needle shield 20 is in the extended position, the proximal needle shield 20 can prevent a delivery device 200 from again being coupled to the proximal needle shield 20 and fluidly connecting to the needle 14.

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Abstract

L'invention concerne une aiguille stylo comprenant un logement et un raccord d'aiguille reçu dans le logement, le raccord d'aiguille ayant une aiguille pourvue d'une extrémité proximale et d'une extrémité distale. Le raccord d'aiguille comprend une paroi d'extrémité distale et une ou plusieurs ouvertures dans la paroi d'extrémité distale du raccord d'aiguille. L'aiguille stylo comprend également une protection d'aiguille distale reçue dans le logement et conçue pour se déplacer entre une position étendue pour recouvrir l'extrémité distale de l'aiguille et une position rétractée pour exposer l'extrémité distale de l'aiguille. L'aiguille stylo comprend également une protection d'aiguille proximale, la protection d'aiguille proximale étant conçue pour se déplacer par rapport au logement entre une position rétractée, une extrémité proximale de la protection d'aiguille proximale étant positionnée à l'intérieur du logement, et une position étendue, l'extrémité proximale de la protection d'aiguille proximale s'étendant depuis le logement.
PCT/US2023/063068 2022-02-22 2023-02-22 Ensemble aiguille stylo avec protection d'aiguille Ceased WO2023164508A2 (fr)

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US202263312700P 2022-02-22 2022-02-22
US63/312,700 2022-02-22

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WO2023164508A2 true WO2023164508A2 (fr) 2023-08-31
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Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2001280762A1 (en) * 2000-08-02 2002-02-13 Becton, Dickinson And Company Pen needle and safety shield system
US7144389B2 (en) * 2001-03-14 2006-12-05 Tyco Healthcare Group, Lp Safety shield for medical needles
US8491535B2 (en) * 2011-04-28 2013-07-23 Becton, Dickinson And Company Safety pen needle assembly

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