WO2023091965A1 - Protecteur rétractable pour ensemble aiguille de stylo - Google Patents

Protecteur rétractable pour ensemble aiguille de stylo Download PDF

Info

Publication number
WO2023091965A1
WO2023091965A1 PCT/US2022/079983 US2022079983W WO2023091965A1 WO 2023091965 A1 WO2023091965 A1 WO 2023091965A1 US 2022079983 W US2022079983 W US 2022079983W WO 2023091965 A1 WO2023091965 A1 WO 2023091965A1
Authority
WO
WIPO (PCT)
Prior art keywords
needle
base
locking member
pen
shield
Prior art date
Application number
PCT/US2022/079983
Other languages
English (en)
Inventor
Kelly Gail DUNCAN
Paul CARSE
William Carr
Sergey Grigoryants
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 WO2023091965A1 publication Critical patent/WO2023091965A1/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
    • A61M5/3205—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
    • A61M5/3205—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
    • A61M5/326—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

Definitions

  • the present disclosure is directed to medical devices for injecting a medication to a patient, and in particular to pen needles with retractable shields.
  • a medication pen for delivering self-administered medications generally includes a pen body, which houses a medication compartment, and a separate pen needle which may 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.
  • 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 base having an axial passage with a proximal end having an opening and a distal end having an opening; a needle hub received in the axial passage and having a needle with a distal end extending from a distal end of the needle hub; a needle shield having an open proximal end for sliding on the base between a first position covering the distal end of the needle and a second position to expose the distal end of the needle; and a removable retaining member on the base for retaining the needle shield in the first position and where the needle shield is movable to the second position when the retaining member is removed from the pen needle.
  • the present disclosure relates to a pen needle, wherein the retaining member is positioned between a proximally facing surface of the needle shield and a distally facing surface of the base.
  • the present disclosure relates to a pen needle, wherein the removable retaining member is a removable band surrounding the base and oriented proximally of the needle shield.
  • the present disclosure relates to a pen needle, wherein the pen needle further includes a locking member received in the base, the locking member being rotatable between a first locking member position where the needle shield is movable relative to the needle hub and a second locking member position where the needle shield is retained in the first position.
  • the present disclosure relates to a pen needle, wherein the locking member has a base member with a distally extending post configured to engage the needle shield when the locking member is in the second locking member position and where the post does not engage needle shield when the locking member is in the first locking member position.
  • the present disclosure relates to a pen needle, wherein the base member of the locking member is oriented on a proximal side of the needle hub and the post extends through an opening in the needle hub to project from a distal side of the needle hub.
  • the present disclosure relates to a pen needle, wherein the locking member is rotatable relative to the base and the needle hub.
  • the present disclosure relates to a pen needle, wherein the needle hub is movable axially relative to the base from a first needle hub position where the locking member is spaced from the needle shield to a distal second needle hub position where the locking member engages the needle shield.
  • the present disclosure relates to a pen needle including: a base having an axial passage with a proximal end having an opening and a distal end having an opening; a needle hub received in the axial passage and having a needle with a distal end extending from a distal end of the needle hub; a needle shield having an open proximal end for sliding on the base between a first position covering the distal end of the needle and a second position to expose the distal end of the needle; and a locking member received in the base, the locking member rotatable between a first locking member position where the needle shield is movable axially relative to the needle hub and a second locking member position where the needle shield is retained in the first position.
  • the present disclosure relates to a pen needle, wherein the locking member has a base member with a distally extending post configured to engage the needle shield when the locking member is in the second locking member position and where the post does not engage the needle shield when the locking member is in the first locking member position.
  • the present disclosure relates to a pen needle, wherein the base member of the locking member is oriented on a proximal side of the needle hub and the post extends through an opening in the needle hub to project from a distal side of the needle hub.
  • the present disclosure relates to a pen needle, wherein the locking member is rotatable relative to the base and the needle hub.
  • the present disclosure relates to a pen needle, wherein the needle hub is movable axially relative to the base from a first needle hub position where the locking member is spaced from the needle shield to a distal second needle hub position where the locking member engages the needle shield.
  • the present disclosure relates to a pen needle, where the pen needle further includes a removable retaining member on the base for retaining the needle shield in the first position and where the needle shield is movable to the second position when the retaining member is removed from the pen needle.
  • the present disclosure relates to a pen needle, wherein the retaining member is positioned between a proximally facing surface of the needle shield and a distally facing surface of the base and where the retaining surrounds the base.
  • the present disclosure relates to a pen needle including: a base having an axial passage with a proximal end having an opening and a distal end having an opening; a needle shield having an open proximal end for sliding on the base between a first position covering a distal end of a needle and a second position to expose the distal end of the needle; and a needle hub received in the axial passage and having the needle with the distal end extending from a distal end of the needle hub, the needle hub being axially movable within the base from a first needle hub position relative to the base and the needle shield and a second needle hub position distal to the first needle hub position without rotation of the needle hub relative to the base.
  • the present disclosure relates to a pen needle, wherein the needle shield covers the distal end of the needle when the needle shield is in the first position and the needle hub is in the first needle hub position and in the second needle hub position.
  • the present disclosure relates to a pen needle, wherein the distal end of the needle extends from a distal end of the needle shield when the needle shield is in the second position and the needle hub is in the second needle hub position.
  • the present disclosure relates to a pen needle, wherein the pen needle further includes a removable retaining member on the base for retaining the needle shield in the first position and where the needle shield is movable to the second position when the retaining member is removed.
  • the present disclosure relates to a pen needle, where the removable retaining member is a removable band surrounding the base and oriented between a proximal end of the needle shield and a distally facing surface of the base.
  • the present disclosure relates to a pen needle, wherein the pen needle further includes a locking member received in the base, the locking member being rotatable between a first locking member position where the needle shield is retained in the first position and a second locking member position where the needle shield is movable to the second position.
  • the present disclosure relates to a pen needle, wherein the locking member has a base member with a distally extending post configured to engage the needle shield when the locking member is in the first locking member position and where the post does not engage the needle shield when the locking member is in the second locking member position.
  • the present disclosure relates to a pen needle, wherein the base member of the locking member is oriented on a proximal end of the needle hub and the post extends through an opening in the needle hub to project from a distal side of the needle hub.
  • the present disclosure relates to a pen needle, wherein the locking member is rotatable relative to the base and the needle hub.
  • the present disclosure relates to a pen needle, wherein an inner surface of the needle shield includes a spring member projecting toward the needle hub to bias the needle shield in a distal direction relative to the needle hub
  • the present disclosure relates to a pen needle, wherein the spring member includes a flexible pole extending from the inner surface of the needle shield.
  • the present disclosure relates to an injection system, including: a delivery device including a supply of medication; and a pen needle, including: a base having an axial passage with a proximal end having an opening and a distal end having an opening; a needle hub received in the axial passage and having a needle with a distal end extending from a distal end of the needle hub; a needle shield having an open proximal end for sliding on the base between a first position covering the distal end of the needle and a second position to expose the distal end of the needle; and a removable retaining member on the base for retaining the needle shield in the first position and where the needle shield is movable to the second position when the retaining member is removed from the pen needle.
  • the present disclosure relates to an injection system, wherein the retaining member is positioned between a proximally facing surface of the needle shield and a distally facing surface of the base.
  • the present disclosure relates to an injection system, wherein the removable retaining member is a removable band surrounding the base and oriented proximally of the needle shield.
  • the present disclosure relates to an injection system, wherein the pen needle further includes a locking member received in the base, the locking member being rotatable between a first locking member position where the needle shield is movable relative to the needle hub and a second locking member position where the needle shield is retained in the first position.
  • the present disclosure relates to an injection system, wherein the locking member has a base member with a distally extending post configured to engage the needle shield when the locking member is in the second locking member position and where the post does not engage needle shield when the locking member is in the first locking member position.
  • the present disclosure relates to an injection system, wherein the base member of the locking member is oriented on a proximal side of the needle hub and the post extends through an opening in the needle hub to project from a distal side of the needle hub.
  • the present disclosure relates to an injection system, wherein the locking member is rotatable relative to the base and the needle hub.
  • the present disclosure relates to an injection system, wherein the needle hub is movable axially relative to the base from a first needle hub position where the locking member is spaced from the needle shield to a distal second needle hub position where the locking member engages the needle shield.
  • the present disclosure relates to an injection system, including: a delivery device including a supply of medicament; and a pen needle according to any one of the prior embodiments.
  • Fig. 1 is a side view a pen needle assembly according to some embodiments
  • FIG. 2 is a bottom perspective view of the pen needle assembly of Fig. 1;
  • Fig. 3 is a cross section view of the pen needle assembly in the initial position
  • Fig. 4 is an exploded view of the pen needle
  • Fig. 5 is a cross sectional view of the pen needle showing the needle shield in the initial position
  • Fig. 6 is a cross sectional view of the pen needle assembly showing the needle shield in the ready position
  • Fig. 7 is a cross sectional view of the needle shield
  • Fig. 8 is a bottom perspective view of the needle shield
  • Fig. 9 is an elevational sectional view of the base of the pen needle
  • Fig. 9A is a perspective view of the base
  • Fig. 10 is a cross sectional view of the base
  • Fig. 11 is a perspective sectional view of the base
  • Fig. 12 is a bottom perspective view of the locking member
  • Fig. 13 is top perspective view of the locking member
  • Fig. 14 is a top perspective view of the needle hub
  • Fig. 15 is a bottom perspective view of the needle hub
  • Fig. 16 is cross sectional side view of the pen needle in the initial position
  • Fig. 17 is a cross sectional side view of the pen needle attached to a delivery device;
  • Fig. 18 is cross sectional side view showing the needle shield and locking member rotated with respect to each other;
  • Fig. 19 is a cross sectional side view showing the retaining member removed from the base
  • Fig. 20 is a cross sectional side view showing the pen needle in the activated position
  • Fig. 21 is a cross sectional side view showing the pen needle in the locked position; and [0040] Fig. 22 is an exploded view of an exemplary delivery device according to some embodiments.
  • FIG. 22 is an exploded view of an exemplary delivery device according to some embodiments.
  • a medication pen or delivery device is used herein to refer to a device having a medication compartment, typically containing multiple doses of medication, and a separate pen needle.
  • 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.
  • the present disclosure is generally directed to a medical device such as an injection device.
  • the injection device can be a pen needle for coupling to an injection pen or other delivery device for delivering a medication.
  • the device can have a shield with patient-contacting surface or skin shaping surface, a hub supporting a cannula, or the needle, an inner sleeve and a locking member.
  • the pen needle hub can be installed on a medication injection pen to administer medications to the patient.
  • the pen needle in some embodiments, 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 for introducing the medication to the patient.
  • the needle can have a proximal end for piercing a septum on the injection pen.
  • the proximal end may be covered by a retractable sleeve on the needle hub that retracts when the needle hub is attached to the injection pen.
  • the pen needle in some embodiments, includes a needle hub, a needle shield covering at least a portion of the needle, and a base receiving the needle hub.
  • the needle shield slides on the base between a first position and a second position proximally of the first position.
  • a removable member can be positioned between the base and the needle shield to prevent movement of the needle shield until ready for use.
  • the removable retaining member is separated from the needle shield and/or the base where the needle shield can move axially to expose the distal end of the needle.
  • the pen needle hub assembly in some embodiments, has a needle hub with a needle or cannula, a base receiving the needle hub, a locking member received in the base, and a needle shield that moves or slides on the base.
  • the needle hub is movable from a first position within the base to a second position distal to the first position.
  • another feature of the needle hub includes a locking member that is rotatable relative to the needle shield between a first position where a needle shield is retained in an extended first position and second position where the needle shield is movable to a retracted position to expose a distal end of the needle.
  • the locking member in the first position contacts or engages the needle shield to prevent proximal movement of the needle shield relative to the base.
  • the locking member in the second position relative to the needle shield does not contact or engage the needle shield in a manner that interferes with the movement of the needle shield so that needle shield can move to a retracted position.
  • the features are basically attained by providing a pen needle comprising a base having an axial passage with a proximal end having an opening and a distal end having an opening.
  • a needle hub is received in the axial passage and has a needle with a distal end extending from a distal end of the needle hub.
  • a needle shield has an open proximal end for sliding on the base between a first position covering a distal end of the needle and a second position to expose the distal end of the needle.
  • a removable retaining member is included on the base for retaining the needle shield in the first position and where the needle shield is movable to the second position when the retaining member is removed.
  • a pen needle comprising a base having an axial passage with a proximal end having an opening and a distal end having an opening and a needle hub received in the axial passage and having a needle with a distal end extending from the distal end of the needle hub.
  • a needle shield has an open proximal end for sliding on the base between a first position covering a distal end of the needle and a second position to expose the distal end of the needle.
  • a locking member is received in the base, where the locking member is rotatable between a first position where the needle shield is retained in the first position and a second position where the needle shield is movable to the second position.
  • the pen needle in some embodiments, can have a convex distal axial surface for shaping the axial face of the needle shield and for shaping the indentation of the surface of the skin during needle insertion and drug delivery.
  • the needle shield can have an axial face with a surface area of about 5- 50 mm 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, which typically comprises a dose knob/button, a body and a cap.
  • the body typically includes a threaded end for coupling with pen needle hub.
  • a dose knob/button allows a user to set the dosage of medication to be injected.
  • the body is gripped by the user when injecting medication.
  • the cap may 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 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 may 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 can be a double-ended cannula beveled and sharpened at both ends for coupling to the pen needle assembly 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 24 is depicted according to some embodiments.
  • the delivery device 24 may be disposable.
  • the delivery device 24 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 24 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 24.
  • 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 24.
  • 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 24.
  • 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 24.
  • the driving and delivery mechanisms of the delivery device 24 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 24 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 16 (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 16 (Fig. 3) located within the pen needle 10 (Fig. 3).
  • the pen needle 10 (Fig. 1) may 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 24, and other designs for the delivery device 24 are contemplated herein.
  • FIG. 1 is a side view a pen needle assembly.
  • Fig. 2 is a bottom perspective view of the pen needle assembly.
  • Fig. 3 is a cross section view of the pen needle assembly.
  • Fig. 4 is an exploded view of the pen needle.
  • Fig. 5 is a cross sectional view of the pen needle showing the needle shield in the initial position.
  • Fig. 6 is a cross sectional view of the pen needle assembly showing the needle shield in the ready position.
  • Fig. 7 is a cross sectional view of the needle shield.
  • Fig. 8 is a bottom perspective view of the needle shield.
  • Fig. 9 is an elevational sectional view of the base of the pen needle.
  • Fig. 1 is a side view a pen needle assembly.
  • Fig. 2 is a bottom perspective view of the pen needle assembly.
  • Fig. 3 is a cross section view of the pen needle assembly.
  • Fig. 4 is an exploded view of the pen needle.
  • Fig. 5 is a cross
  • FIG. 9A is a perspective view of the base.
  • Fig. 10 is a cross sectional view of the base.
  • Fig. 11 is a perspective sectional view of the base.
  • Fig. 12 is a bottom perspective view of the locking member.
  • Fig. 13 is top perspective view of the locking member.
  • Fig. 14 is a top perspective view of the needle hub.
  • Fig. 15 is a bottom perspective view of the needle hub.
  • Fig. 16 is cross sectional side view of the pen needle in the initial position.
  • Fig. 17 is a cross sectional side view of the pen needle attached to a delivery device.
  • Fig. 18 is cross sectional side view showing the needle shield rotated.
  • Fig. 19 is a cross sectional side view showing the retaining member removed from the base.
  • Fig. 20 is a cross sectional side view showing the pen needle in the activated position.
  • Fig. 21 is a cross sectional side view showing the pen needle in the locked position.
  • the pen needle 10 as shown in the drawings includes a base 12, a needle hub 14 having a needle 16, and a needle shield 18.
  • the needle shield 18 is configured for moving axially to expose the needle 16 during use and to cover the needle 16 after use.
  • the base 12 of the pen needle 10 (Fig. 1) is depicted.
  • the base 12 of the pen needle 10 may have a substantially cylindrical wall 20 having an axial passage 26 with an open proximal end 28 and an open distal end 30.
  • the wall 20 has an inner surface with internal threads 22 for coupling with a delivery device 24, as shown in Figs. 16-21.
  • the internal threads 22 are spaced from the proximal end 28 so that the delivery device 24 (Figs. 16-21) is inserted into the axial passage 26 at the open proximal end 28 of the base 12.
  • the open proximal end 28 has an outwardly extending flange and an inner surface with a first portion having an inner diameter greater than a second portion distal to the first portion to assist in placing the base 12 on the delivery device 24 (Figs. 16-21) to thread the end of the delivery device 24 into the base 12.
  • the outer surface of the wall 20 has longitudinally extending ribs 32 projecting radially outward for guiding the needle shield 18 (Figs. 1- 8).
  • the wall 20 includes a first recess in the form of an open slot 34 spaced proximally from the distal end of the base 12 and a second recess in the form of a notch or slot 36 at the distal end of the base 12, as shown in Figs. 9A and 10.
  • the inner surface of the wall 20 includes pairs of longitudinally extending ribs 38 where each pair of ribs 38 form a guide groove 40 between the ribs 38.
  • the pairs of ribs 38 and the guide grooves 40 are spaced around the periphery of the inner surface of the wall 20.
  • the needle shield 18 has a side wall 42 with an open proximal end 44 and an end wall 46 at a distal end 48.
  • a centrally oriented opening 50 in the end wall 46 is provided for the needle 16 (Fig. 3) to pass through when the needle shield 18 is in the retracted position relative to the base 12 (Figs. 9-11).
  • the outer surface of the side wall 42 has axially extending ribs 52 to assist the user for gripping the pen needle.
  • the inner surface of the side wall 42 has axially extending grooves 54 complementing the ribs 32 (Figs. 9A-11) on the base 12 for guiding the needle shield 18 on the base 12 in an axial direction.
  • the needle shield 18 moves axially on the base 12 (Figs. 9-11) between a retracted position and an extended position.
  • grooves 54 provide for axial movement or sliding on base 12 (Figs. 9-11) so that the needle shield 18 is rotationally fixed relative to the base 12 so that the needle shield 18 does not rotate on the base 12.
  • the inner face of the end wall 46 includes axially extending posts 56 that extend in a proximal direction.
  • the posts 56 are oriented on opposite sides of the centrally oriented opening 50 and extend axially a distance less than an axial length of the side wall 42.
  • the posts 56 are oriented to contact the posts 108 (Figs. 12 and 13) when the needle shield 18 is locked in extended position after use.
  • the needle hub 14 has a body 60 with a substantially cylindrical shape to move within the base 12 (Figs. 9-11).
  • the body 60 is formed by a side wall 62 extending axially from an end wall 64.
  • the outer surface of the side wall 62 includes a plurality of axially extending ribs 66 that are spaced around the periphery of the side wall 62.
  • the ribs 66 are oriented to align with the internal guide grooves 40 (Figs. 9A-11) of the base 12 (Figs.
  • a proximal end of the side wall 62 is provided with a series of radially oriented ribs 68.
  • the end wall 64 is spaced distally from the proximal end ofthe side wall 62 to form a recess 101.
  • arcuate shaped openings 118 extend through the end wall 64 of the needle hub 14.
  • a biasing member such as a spring, is included to bias the needle shield 18 in a distal extended direction relative to the base 12.
  • a spring member 120 is formed with the needle hub 14 and is configured to engage an inner surface of the needle shield 18 to bias the needle shield 18 to the extended position with respect to the base 12.
  • the spring member 120 is in the form of a flexible and resilient pole extending axially from the distal end ofthe needle hub 14 a distance to contact the needle shield 18.
  • the spring member 120 deflects and bends when the needle shield 18 is moved to the retracted position.
  • the spring member 120 is sufficiently resilient to bias the needle shield 18 to the extended position by releasing the retracting force on the needle shield 18.
  • the biasing member can be a separate spring member 120 positioned between the needle hub 14 and the needle shield 18.
  • a latching member 70 is included with the needle hub 14 at the distal end and extends distally relative to the needle hub 14.
  • the latching member 70 is formed by an axially extending leg 72 with a hook member 74 projecting radially outward with respect to the side wall 62 and the leg 72.
  • the leg 72 is sufficiently flexible to bend inwardly and spring back to the original position.
  • the hook member 74 as shown has a substantially flat proximal surface 76 and an inclined distal surface 78.
  • the end wall 64 ofthe needle hub 14 has a central opening extending through the end wall 64 for receiving and supporting the needle 16.
  • the needle 16 can be coupled to the needle hub 14 by an adhesive or other attachment mechanism.
  • the needle 16, as shown has a distal end 80 extending from the distal end of the needle hub 14 and a proximal end 82 extending from the proximal end of the needle hub 14.
  • the distal end 80 of the needle 16 has a length to extend from the needle shield 18 (Fig. 3) a distance to expose the needle 16 when the needle shield 18 is retracted relative to the base 12 (Fig. 3) for delivering the medication to a patient.
  • the proximal end 82 of the needle 16 has a length to pierce a septum of the delivery device 24 (Figs. 16-21) to receive the medication.
  • the pen needle 10 includes a locking member 84 received in the axial passage 26 (Figs. 9 and 9A) of the base 12 as shown in Figs. 3 and 6.
  • the locking member 84 is oriented on a proximal side of the needle hub 14 and is movable axially with the needle hub 14 and rotatable a limited amount relative to the needle hub 14.
  • the locking member 84 includes a base member 86 with a distal surface 88 and a proximal surface 90.
  • the base member 86 in some embodiments, has a circular shape with a diameter corresponding substantially to an inner diameter of the side wall 62 (Figs. 14 and 15) of the needle hub 14 (Figs. 14 and 15).
  • the proximal end of the base member 86 has a radially extending lip 92 with an outer diameter corresponding substantially to an outer diameter of the needle hub 14.
  • the distal face of the lip 92 has a series of spaced apart ribs 94 complementing the ribs 68 (Fig.
  • a side surface 96 of the base member 86 includes outwardly extending projections 98 for mating with a complementing recess 100 (Fig. 15) on the inner surface of the side wall 62 (Fig. 15) of the needle hub 14 (Fig. 15) at the proximal end of the needle hub 14 to couple the locking member 84 to the needle hub 14.
  • the proximal surface 90 of the base member 86 has an annular ring 102 extending axially in the proximal direction and spaced radially inward from a peripheral edge of the radial lip 92.
  • arcuate shaped members 104 project proximally from the proximal surface 90 of the base member 86 on opposite sides of a central opening 106.
  • two axially extending posts 108 project from the distal surface 88 of the base member 86 of the locking member 84 on opposite sides of the central opening 106.
  • the posts 108 are oriented to extend through the arcuate openings 118 (Fig. 15) in the needle hub 14 (Fig. 15) and to align with the posts 56 (Figs. 7 and 8) on the needle shield 18 (Figs. 7 and 8).
  • the posts 108 have a length to engage the posts 56 (Figs. 7 and 8) of the needle shield 18 (Figs. 7 and 8) when the respective posts are aligned and the needle shield 18 is in the extended position.
  • the posts 108 have a dimension less than a dimension of the arcuate openings 118 (Fig. 15) in the needle hub 14 (Fig. 15) to allow limited rotational movement of the locking member 84 relative to the needle hub 14.
  • the pen needle 10 includes a retaining member 110 on the base 12 that is oriented proximally of the needle shield 18.
  • the retaining member 110 is a removable member that can retain the needle shield 18 in a first extended position shown in Fig. 5 and Fig. 16, and when the retaining member 110 is removed, allows the needle shield 18 to retract relative to the base 12 and the needle hub 14.
  • the retaining member 110 in some embodiments, is a plastic flexible band that surrounds the outer surface of the base 12 to block the proximal movement of the needle shield 18 relative to the base 12.
  • the terminal ends of the retaining member 110 can be coupled by a frangible line that can be broken or tom to remove the retaining member 110 from the base 12.
  • a tab 112 can be provided on one end of the retaining member 110 to assist the user in breaking the frangible line and for removing the retaining member 110.
  • the retaining member 110 is positioned between a proximally facing surface 114 of the needle shield 18 and a distally facing surface 116 of the base 12.
  • the retaining member 110 can be coupled to the needle shield 18 by a frangible line.
  • the retaining member 110 can be coupled to the base 12 by a frangible line.
  • the retaining member 110 is a separate band-like member around the base 12.
  • the end wall 46 of the needle shield 18 can have, in some embodiments, a convex outer surface for contacting the skin of the patient during an injection and deforming the surface of the skin to a predetermined shape when pressed against the skin.
  • the convex surface can have a width or diameter of greater than 3.0 mm and typically about 5.0 to 8.0 mm and a height of about 0.5 to about 1.5 mm measured from the outer peripheral edge of the surface to the outermost center portion of the surface surrounding the needle 16 (Fig. 3) and spaced axially from the peripheral edge.
  • the convex surface has a radius of curvature of about 5.0 to 8.0 mm.
  • the convex surface has a height of about 1.0 mm and a diameter of about 7.0 mm. In some embodiments, the convex surface can have a radius of curvature of 6.0 to 16.0 mm. In some embodiments, the convex surface has a radius of curvature of 6.0 to 9.0 mm. In some embodiments, the convex surface can have a radius of curvature of 6.0 to 7.0 mm. In some embodiments, the convex surface has a radius of curvature equal to or greater than the diameter of the convex surface. In some embodiments, the radius curvature can be about 1 to 1 1/2 times the diameter of the convex surface.
  • the ratio of the diameter (D) to the height (H) of the convex surface influences the depth of penetration of the needle 16 (Fig. 3) on insertion into the skin. Generally, the larger the ratio provides more surface area of the needle shield 18 that will contact the skin and provide greater control of the depth of penetration. A smaller ratio D:H provides a smaller surface area that can compress the skin on insertion of the needle 16 (Fig. 3) and result in a deeper penetration of the needle 16.
  • the ratio of the diameter to the height of the convex surface can range from about 2: 1 to 10:1. In some embodiments, the ratio can range from about 5:1 to 8:1.
  • the shape and contour of the axial face of the post controls the shape and contour of the end wall of the sleeve when pressed against the surface of the skin.
  • the pen needle 10 is assembled as shown in Figs. 1-6 where the needle hub 14 is positioned in the axial passage 26 (Figs. 9 and 9A) of the base 12.
  • the axial ribs 66 (Figs. 14 and 15) on the outer surface of the needle hub 14 slide within the guide grooves 40 (Figs. 9-11) formed on the inner surface of the base 12.
  • the ribs 66 (Figs. 14 and 15) and the corresponding guide grooves 40 (Figs. 9-11) limit rotational movement of the needle hub 14 relative to the base 12 while allowing axial movement of the needle hub 14 relative to the base 12.
  • the hook member 74 (Figs. 14 and 15) of the needle hub 14 is received in the slot 34 in the wall 20 (Fig.
  • the needle shield 18 is positioned on an outer surface of the base 12 where the axially extending ribs 32 (Figs. 9A-11) of the base 12 are received in the grooves 54 (Figs. 7 and 8) of the needle shield 18. The needle shield 18 is able to move and/or slide axially on the base 12.
  • the pen needle 10 as shown in Fig. 5 and Fig 16 has the needle hub 14 and the locking member 84 in the proximal position within the base 12 where the hook member 74 (Figs. 14 and 15) of the needle hub 14 is received in the slot 34.
  • the locking member 84 is oriented on a proximal side of the needle hub 14 with the posts 108 extending through the arcuate openings 118 (Figs. 14 and 15) in the end wall 64 of the needle hub 14.
  • the posts 56 of the needle shield 18 are spaced axially from the posts 108 and misaligned with the posts 108 so that the needle shield 18 is able to move axially relative to the needle hub 14 and the locking member 84.
  • the posts 56 of the needle shield 18 are spaced axially from the posts 108 of the locking member 84 and misaligned with the posts 108 such that the posts 56 of the needle shield 18 do not engage the posts 108 of the locking member 84.
  • the base 12 is coupled to the end of the delivery device 24 where the delivery device 24 contacts the proximal end of the locking member 84 to move the locking member 84 and the needle hub 14 distally to the position shown in Fig. 17.
  • the axial force applied to the locking member 84 and needle hub 14 separates the hook member 74 from the first slot 34 so that the needle hub 14 and locking member 84 slide distally to a second position shown in Fig. 6 where the hook member 74 is received in the second slot 36 to retain the needle hub 14 and the locking member 84 in an extended distal position relative to the base 12.
  • the distal end of the needle 16 is positioned within the needle shield 18, and the posts 56 of the needle shield 18 are misaligned with the posts 108 of the locking member 84.
  • the proximal end of the needle 16 pierces the septum of the delivery device 24 to supply the medication to the needle 16.
  • the retaining member 110 may then be separated from the pen needle 10 to allow the needle shield 18 to move proximally where the posts 56 of the needle shield 18 move past the posts 108 of the locking member 84.
  • the pen needle 10 is pressed against the skin of the patient where the needle shield 18 is able to move to a retracted position shown in Fig. 20 to expose the distal end of the needle 16 for delivering the medication to the patient.
  • the pen needle 10 is withdrawn from the patient where the spring member 120 or other biasing member moves the needle shield 18 distally to cover the distal end of the needle 16.
  • the arcuate members 104 (Fig.
  • the locking member 84 engages the distal end of the delivery device 24 with sufficient frictional force so that when the delivery device 24 is unscrewed from the pen needle 10, the locking member 84 rotates relative to the needle hub 14 within the limits of the arcuate shaped openings 118 (Figs. 14 and 15) to a position where the distal ends of the posts 108 and the proximal ends of the posts 56 are aligned to prevent further proximal movement of the needle shield 18 relative to the base 12.
  • the pen needle 10 can then be discarded with the distal end 80 of the needle 16 protected by the needle shield 18 locked in the extended position and the proximal end 82 of the needle 16 recessed within the open proximal end of the base 12 a distance to prevent inadvertent needle stick.

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

Abstract

L'invention concerne une aiguille de stylo comprenant une base ayant un passage axial avec une extrémité proximale ayant un dégagement et une extrémité distale ayant une ouverture, un raccord d'aiguille reçu dans le passage axial et ayant une aiguille ayant une extrémité distale s'étendant à partir d'une extrémité distale du raccord d'aiguille, et un protecteur d'aiguille ayant une extrémité proximale ouverte pour coulisser sur la base entre une première position recouvrant l'extrémité distale de l'aiguille et une seconde position pour exposer l'extrémité distale de l'aiguille. L'aiguille de stylo comprend également un élément de retenue amovible sur la base pour retenir le protecteur d'aiguille dans la première position. Le protecteur d'aiguille est mobile vers la seconde position lorsque l'élément de retenue est retiré de l'aiguille de stylo.
PCT/US2022/079983 2021-11-17 2022-11-16 Protecteur rétractable pour ensemble aiguille de stylo WO2023091965A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202163280410P 2021-11-17 2021-11-17
US63/280,410 2021-11-17

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WO2023091965A1 true WO2023091965A1 (fr) 2023-05-25

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5041088A (en) * 1988-08-23 1991-08-20 Medimech International Ltd. Multiple chamber automatic injector
US20050283115A1 (en) * 2000-08-02 2005-12-22 Lucio Giambattista Pen needle and safety shield system
US20120277724A1 (en) * 2000-05-31 2012-11-01 Novo Nordisk A/S Disposable Double Point Injection Needle and an Insulin Injection System Comprising a Disposable Double Point Injection Needle
US20170021110A1 (en) * 2013-12-04 2017-01-26 Becton, Dickinson And Company Pen Needle Attachment Mechanisms
US20200030548A1 (en) * 2008-08-15 2020-01-30 Becton, Dickinson And Company Safety pen needle assembly

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5041088A (en) * 1988-08-23 1991-08-20 Medimech International Ltd. Multiple chamber automatic injector
US20120277724A1 (en) * 2000-05-31 2012-11-01 Novo Nordisk A/S Disposable Double Point Injection Needle and an Insulin Injection System Comprising a Disposable Double Point Injection Needle
US20050283115A1 (en) * 2000-08-02 2005-12-22 Lucio Giambattista Pen needle and safety shield system
US20200030548A1 (en) * 2008-08-15 2020-01-30 Becton, Dickinson And Company Safety pen needle assembly
US20170021110A1 (en) * 2013-12-04 2017-01-26 Becton, Dickinson And Company Pen Needle Attachment Mechanisms

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