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WO2025111337A1 - Capuchon pour stylo injecteur - Google Patents

Capuchon pour stylo injecteur Download PDF

Info

Publication number
WO2025111337A1
WO2025111337A1 PCT/US2024/056667 US2024056667W WO2025111337A1 WO 2025111337 A1 WO2025111337 A1 WO 2025111337A1 US 2024056667 W US2024056667 W US 2024056667W WO 2025111337 A1 WO2025111337 A1 WO 2025111337A1
Authority
WO
WIPO (PCT)
Prior art keywords
needle
closed end
protrusion
cap
shape
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.)
Pending
Application number
PCT/US2024/056667
Other languages
English (en)
Inventor
Raja Peter DHAYALAN
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.)
Becton Dickinson and Co
Original Assignee
Becton Dickinson and Co
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 Becton Dickinson and Co filed Critical Becton Dickinson and Co
Publication of WO2025111337A1 publication Critical patent/WO2025111337A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; 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
    • A61M5/3205Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321Means for protection against accidental injuries by used needles
    • A61M5/3213Caps placed axially onto the needle, e.g. equipped with finger protection guards
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/58Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/583Means for facilitating use, e.g. by people with impaired vision by visual feedback

Definitions

  • the present invention relates to medical devices, and more particularly, to injector pens.
  • diabetic patients may need multiple doses of insulin throughout the day.
  • Some diabetic patients may use insulin pumps, which are small computerized devices that deliver insulin throughout the day.
  • Other patients may perform self-injection of insulin by using a syringe or an injector pen.
  • An injector pen is a device for injecting medicine repeatedly over a period of time.
  • An injector pen may include a reservoir for containing medication, a pen needle, a dose selection dial, a plunger, and a plunger button.
  • pen needles There are two types of pen needles primarily used: a standard pen needle and a safety pen needle.
  • Standard pen needles include a removable outer cover, an inner cap that is removable, and a fixed needle.
  • a patient must remove both the removable outer cover and the inner cap before performing an injection.
  • Some safety pen needles include a removable outer cover, a fixed inner needle shield, and a mobile needle that extends beyond the fixed inner cover during use of the insulin pen, but is otherwise covered by the fixed inner needle shield.
  • a patient To use an injector pen with such a safety pen needle, a patient must remove the removable outer cover, but does not remove the fixed inner cover.
  • the needle cap includes a body having a closed end and an open end and a protrusion extending from the closed end for indicating that a needle will not pass through the closed end.
  • Another aspect of the present invention is to provide a system for an injection pen needle.
  • the system includes a needle assembly including a needle base and a needle fixed to and extending from the needle base.
  • the system further includes an inner needle cap removably connected to the needle base for covering the needle.
  • the inner needle cap includes a body having a closed end and an open end and a protrusion extending from the closed end for indicating that a needle will not pass through the closed end.
  • the system further includes an outer needle cover for covering the inner needle cap and the needle assembly.
  • Yet another aspect of the present invention is to provide a system for an injection pen needle.
  • the system includes a needle assembly including a needle base and a needle fixed to and extending from the needle base.
  • the system further includes an inner needle cap removably connected to the needle base for covering the needle.
  • the inner needle cap includes a body having a cylindrical shape and having a closed end having a circular shape and an open end anda protrusion extending from the closed end and over a geometric center of the closed end for indicating that a needle will not pass through the closed end.
  • the system further includes an outer needle cover for covering the inner needle cap and the needle assembly.
  • FIG. 1 is an exploded side view of a related art pen needle and inner needle cap
  • FIG. 2 is a side view of a related art inner needle cap of FIG. 1 ;
  • FIG. 3 is an exploded side view of a related art safety pen needle
  • FIGS. 4A-4D are perspective views of modified inner needle caps according to exemplary embodiments of the present invention.
  • FIGS. 5A-5D are perspective views of modified inner needle caps according to further exemplary embodiments of the present invention.
  • connection Unless limited otherwise, the terms “connected,” “coupled,” and “mounted,” and variations thereof herein are used broadly and encompass direct and indirect connections, couplings, and mountings. In addition, the terms “connected” and “coupled”” and variations thereof are not restricted to physical or mechanical connections or couplings. Further, terms such as “up,” “down,” “bottom,” “top,” “front,” “rear,” “upper,” “lower,” “upwardly,” “downwardly,” and other orientational descriptors are intended to facilitate the description of the exemplary embodiments of the present invention, and are not intended to limit the structure of the exemplary embodiments of the present invention to any particular position or orientation.
  • FIG. 1 illustrates an injector pen having a standard pen needle 22.
  • the injector pen includes, for example, a body, which may be plastic, such as polycarbonate, polypropylene, or polyethylene.
  • a front part which may be metal, such as stainless steel extends from the plastic body, and the standard pen needle extends from the front part.
  • a cartridge containing a medication may be placed at least partially within the plastic body.
  • the front part may include a clear cartridge window and an indicator scale for allowing a patient to view the cartridge and determine an amount of medication remaining in the cartridge.
  • the plastic body further includes a body window for allowing the patient to view the cartridge, a clip-on panel, a dose display indicating a dose value (i.e., a quantity of medication to be injected), an injection button for initiating injection of the medication, and a cartridge release button for releasing the cartridge for replacement.
  • a needle guard and front cap are both removably connected to the body for covering the standard pen needle 22.
  • FIG. 1 further illustrates the standard pen needle 22.
  • the standard pen needle 22 includes a needle assembly 48 connected to the front part of the injector pen.
  • the needle assembly includes a needle base 50 and a hollow needle 52 fixed to and extending from the needle base 50.
  • a removable inner needle cap 54 is removably connected to the needle base 50 and covers the hollow needle 52 when attached.
  • the inner needle cap 54 is generally shaped as a cylinder with one end covered and the other end opened.
  • An outer needle cover 56 is removably connected to the front part of the injector pen or the needle base 50 for covering the inner needle cap 54 and the needle assembly 48.
  • both the outer needle cover 56 and the inner needle cap 54 must be removed to allow for injection of the medication in the cartridge.
  • the hollow needle 52 of the injector pen is then inserted into a patient’s body.
  • FIG. 2 shows a side view of the inner needle cap 54.
  • the inner needle cap 54 includes a cylindrical body 58, a circular closed end 60, and a circular open end 62 that may include a rim 64.
  • FIG. 3 shows a safety pen needle 70.
  • the safety pen needle 70 includes a needle assembly 72 including a needle base 74, a fixed inner needle shield 76, and needle 78 movable relative to the fixed inner needle shield 76.
  • the fixed inner needle shield 76 is generally shaped as an open cylinder.
  • An outer needle cover 80 is removably connected to the needle base 74 or another feature of an injector pen for covering the needle assembly 72.
  • the outer needle cover 80 must be removed, but the fixed inner needle shield 76 is not removed.
  • the injector pen is placed into contact with human skin and the needle 78 is actuated to extend beyond the fixed inner needle shield 76 and into a patient’s body.
  • FIGS. 4A-4D show various exemplary of inner needle caps 154 in accordance with embodiments of the present invention.
  • the inner needle caps 154 each include a cylindrical body 58, a circular closed end 60, and a circular open end 62.
  • the circular open end 62 may include a rim.
  • each of the modified inner needle caps 154 include an indicator protrusion 166 extending from the circular closed end 60 such that the protrusion extends over the geometric center of the circular closed end.
  • the indicator protrusion 166 has a semi-circular arc shape 190.
  • the indicator protrusion 166 has a torus shape 192.
  • the indicator protrusion 166 has a pillar 194 supporting an oval toroid shape 196.
  • the indicator protrusion 166 has a T-shape formed from a pillar 198 supporting a cylinder 200 perpendicular to the pillar 198.
  • the indicator protrusions 166 extending from the circular closed ends 60 provide an indication to a patient that the hollow needle 52 of the standard pen needle 22 will not pass through the circular closed end 60 of the modified inner needle caps 154, as there is clearly more solid, physical structure through which the hollow needle 52 would have to pass to perform the injection.
  • These indicator protrusions 166 thus prevent confusion in patients and prevent patients from assuming the hollow needle 52 is entering their body while the modified inner needle cap 154 is in place. As such, the patients will be more likely to receive the medication as expected, even if the patients are trained using an injector pen with a safety pen needle 70 and are later provided with an injector pen with a standard pen needle 22 with which the patients are not trained.
  • FIGS. 5A-5D show various exemplary of inner needle caps 154 in accordance with further embodiments of the present invention. Similar to the embodiments described above with respect to FIGS. 4A-4D, in the illustrated embodiments of FIGS. 5A-5D, the inner needle caps 154 each include a cylindrical body 58, a circular closed end 60, and a circular open end 62. But one skilled in the art will appreciate that embodiments of the preset invention can have other shapes without departing from the present invention’s scope.
  • the circular open end 62 includes a rim 64.
  • each of the modified inner needle caps 154 include an indicator protrusion 166 extending from the circular closed end 60 such that the protrusion extends over the geometric center of the circular closed end.
  • each of the modified inner caps 154 includes a concave cavity 65 disposed on the circular closed end 60. The concave cavity 65 advantageously provides a space for a linger of the patient to rest while more effectively holding the indicator protrusion 166.
  • the indicator protrusion 166 has a semi-circular arc shape 190.
  • the indicator protrusion 166 has a torus shape 192.
  • at a central portion of the concave cavity 65 includes a central protrusion 61.
  • the central protrusion 61 advantageously provides a tactile surface that acts as a friction surface for the finger of the patient to engage.
  • the central protrusion 61 cooperates with the indicator protrusion 166 to advantageously indicate to the patient that the hollow needle 52 of the standard pen needle 22 will not extend through the circular closed end 60.
  • the indicator protrusion 166 has a pillar 194 supporting an oval toroid shape 196.
  • the indicator protrusion 166 has a T-shape formed from a pillar 198 supporting a cylinder 200 perpendicular to the pillar 198.
  • the pillars 196, 198 in FIGS. 5C and 5D also advantageously indicate to the patient that the needle will not extend through the circular closed end 60.
  • the indicator protrusions 166 of FIGS. 5A-5D extending from the circular closed ends 60 provide an indication to a patient that the hollow needle 52 of the standard pen needle 22 will not pass through the circular closed end 60 of the modified inner needle caps 154, as there is clearly more solid, physical structure through which the hollow needle 52 would have to pass to perform the injection.
  • These indicator protrusions 166 thus prevent confusion in patients and prevent patients from assuming the hollow needle 52 is entering their body while the modified inner needle cap 154 is in place. As such, the patients will be more likely to receive the medication as expected, even if the patients are trained using an injector pen with a safety pen needle 70 and are later provided with an injector pen with a standard pen needle 22 with which the patients are not trained.
  • the present invention is not limited to the described embodiments.
  • different shapes and forms of the indicator protrusion 166 may be used.
  • the body of the modified inner needle cap 154 may be a shape other than cylindrical (e.g., a triangular prism, a rectangular prism, etc.). It will be appreciated by those skilled in the art that other changes may also be made to the disclosed embodiments without departing from the scope of the invention.
  • any of the embodiments, features and/or elements disclosed herein may be combined with one another to form various additional combinations not specifically disclosed, as long as the embodiments, features and/or elements being combined do not contradict each other.

Landscapes

  • 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 un capuchon d'aiguille pour un stylo injecteur comprenant un corps ayant une extrémité fermée et une extrémité ouverte et une saillie s'étendant à partir de l'extrémité fermée pour indiquer qu'une aiguille ne passe pas à travers l'extrémité fermée.
PCT/US2024/056667 2023-11-22 2024-11-20 Capuchon pour stylo injecteur Pending WO2025111337A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202363601991P 2023-11-22 2023-11-22
US63/601,991 2023-11-22

Publications (1)

Publication Number Publication Date
WO2025111337A1 true WO2025111337A1 (fr) 2025-05-30

Family

ID=95827417

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2024/056667 Pending WO2025111337A1 (fr) 2023-11-22 2024-11-20 Capuchon pour stylo injecteur

Country Status (1)

Country Link
WO (1) WO2025111337A1 (fr)

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9757524B2 (en) * 2012-07-30 2017-09-12 Ucb Biopharma Sprl Auto-injector
US10441728B2 (en) * 2013-11-28 2019-10-15 Sanofi-Aventis Deutschland Gmbh Needle safety device and drug delivery device
US10661024B2 (en) * 2016-03-23 2020-05-26 West Pharmaceutical Services, Inc. Two piece needle shield puller
US20230310754A1 (en) * 2015-12-08 2023-10-05 Becton Dickinson France S.A.S. Cap for Medical Injector

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9757524B2 (en) * 2012-07-30 2017-09-12 Ucb Biopharma Sprl Auto-injector
US10441728B2 (en) * 2013-11-28 2019-10-15 Sanofi-Aventis Deutschland Gmbh Needle safety device and drug delivery device
US20230310754A1 (en) * 2015-12-08 2023-10-05 Becton Dickinson France S.A.S. Cap for Medical Injector
US10661024B2 (en) * 2016-03-23 2020-05-26 West Pharmaceutical Services, Inc. Two piece needle shield puller

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