WO2025207902A1 - Collier rotatif pour dispositifs d'injection - Google Patents

Collier rotatif pour dispositifs d'injection

Info

Publication number
WO2025207902A1
WO2025207902A1 PCT/US2025/021782 US2025021782W WO2025207902A1 WO 2025207902 A1 WO2025207902 A1 WO 2025207902A1 US 2025021782 W US2025021782 W US 2025021782W WO 2025207902 A1 WO2025207902 A1 WO 2025207902A1
Authority
WO
WIPO (PCT)
Prior art keywords
collar
injection device
plunger
shroud
recesses
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/US2025/021782
Other languages
English (en)
Inventor
Alexander Hee-Hanson
Thomas LEVER
Michael Parrott
Robert Wilson
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.)
Genzyme Corp
Original Assignee
Genzyme 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
Priority claimed from US18/620,210 external-priority patent/US12274866B1/en
Application filed by Genzyme Corp filed Critical Genzyme Corp
Publication of WO2025207902A1 publication Critical patent/WO2025207902A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M5/2033—Spring-loaded one-shot injectors with or without automatic needle insertion
    • 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
    • A61M5/3271—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel with guiding tracks for controlled sliding of needle protective sleeve from needle exposing to needle covering position
    • A61M5/3272—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel with guiding tracks for controlled sliding of needle protective sleeve from needle exposing to needle covering position having projections following labyrinth paths
    • 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
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M2005/2006—Having specific accessories
    • A61M2005/2013—Having specific accessories triggering of discharging means by contact of injector with patient 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
    • 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
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31501—Means for blocking or restricting the movement of the rod or piston
    • A61M2005/31508—Means for blocking or restricting the movement of the rod or piston provided on the piston-rod
    • 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

  • This application relates to an injector device for delivery of a medicament, particularly to an auto-injector device.
  • An auto-injector may be described as a device which completely or partially replaces the activities involved in parenteral drug delivery from a standard syringe. Typically, these include removal of the protective syringe cap, insertion of the needle, injection of drug and possibly removal and shielding of the used needle. Administering an injection is a process which presents several risks and challenges, both mental and physical. The use of an auto-injector can bring many benefits for the user and healthcare professional.
  • the activation or hold force is too high or has a certain profile, it can lead to use issues such as incorrectly thinking the device is not working, inadvertent early removal or a wet injection site. Some users have difficulty applying this hold force during the full drug delivery time. This results in pain, discomfort, a wet injection site, early device removal and partial drug delivery.
  • an injection device includes: an injection device body; a plunger including one or more plunger recesses; biasing means for applying a biasing force to bias the plunger in a distal direction of the injection device; a casing at least partially enclosing the plunger, the casing including one or more toothed beams each including a tooth engageable with a corresponding plunger recess of the one or more plunger recesses; and a rotatable collar at least partially enclosing the casing and including one or more collar recesses on an inner surface of the rotatable collar; and wherein: each of the one or more plunger recesses is shaped to urge a tooth of the corresponding toothed beam outwards when the biasing force is applied to the plunger in a pre-use configuration; and the one or more collar recesses are shaped to cooperate with a tooth of a corresponding toothed beam to apply a torque to the rotatable collar when the corresponding toothed
  • the rotatable collar may further include a cam track on an outer surface of the rotatable collar.
  • the injection device may further include a needle shroud retractable into the injection device and including a shroud pin engageable with the cam track of the rotatable collar.
  • the cam track is shaped to guide the shroud pin from an initial position to a hold position and cause the collar to rotate relative to the injection device body during retraction of the needle shroud.
  • the cam track may include an initial portion aligned with the biasing force direction and including a retaining edge arranged to contact the shroud pin in the pre-use position to prevent rotation of the collar with respect to the plunger and/or casing.
  • the cam track may include an angled portion arranged to contact the shroud pin for at least a part of the retraction of the needle shroud, thereby applying a torque to the rotatable collar during retraction of the needle shroud.
  • the cam track may further include a final portion for guiding the shroud pin from the hold position to a final position, the final portion including a locking mechanism to prevent retraction of needle shroud after the shroud pin has reached the final position.
  • the one or more teeth of the one or more toothed beams may be chamfered in the distal direction.
  • Each tooth may extend inwardly in a radial direction from the respective toothed beam.
  • An outside surface of each tooth may be chamfered in an axial direction to form a tooth contact surface for contacting the recess in a pre-use configuration.
  • the one or more collar recesses may each include a collar contact surface for contacting the tooth contact surface of the respective tooth in the pre-use configuration.
  • Each collar contact surface may include a curved surface that has a radial depth that increases in the opposite direction to the rotation direction of the collar.
  • the one or more plunger recesses may include a curved edge at a proximal end of the plunger recess.
  • the one or more plunger recesses may include a plurality of plunger recesses arranged evenly around the plunger in an angular/azimuthal direction.
  • the one or more toothed beams may include a corresponding plurality of toothed beams arranged evenly around the casing in the angular/azimuthal direction.
  • the one or more collar recesses may include a corresponding plurality of collar recesses arranged evenly around the inside surface of the collar in the angular/azimuthal direction.
  • the injection device may further include a needle for expelling medicament from a medicament cartridge.
  • the injection device may further include a medicament cartridge containing a medicament.
  • a tubular collar for an injection device includes: an outer surface; an inner surface; one or more collar recesses on the inner surface of the tubular collar, the one or more collar recesses are shaped to cooperate with a tooth of a corresponding toothed beam of an injection device casing to apply a torque to the tubular collar when the corresponding toothed beam is urged outwards; and a cam track on the outer surface of the rotatable collar wherein the cam track is shaped to guide a shroud pin of a needle shroud from an initial position to a hold position and apply a torque to the tubular collar during retraction of the needle shroud.
  • the cam track may include an initial portion aligned with the biasing force direction and including a retaining edge arranged to contact the shroud pin in the pre-use position to prevent rotation of the collar with respect to the plunger and/or casing.
  • the cam track may include an angled portion arranged to contact the shroud pin for at least a part of the retraction of the needle shroud, thereby applying a torque to the rotatable collar during retraction of the needle shroud.
  • the cam track may further include a final portion for guiding the shroud pin from the hold position to a final position, the final portion including a locking mechanism to prevent retraction of needle shroud after the shroud pin has reached the final position.
  • the one or more collar recesses may each include a collar contact surface for contacting the tooth contact surface of the respective tooth of a corresponding toothed beam in the pre-use configuration.
  • Each collar contact surface may include a curved surface that has a radial depth that increases in the opposite direction to the rotation direction of the collar.
  • a drug delivery device may be configured to inject a medicament into a subject.
  • delivery could be sub-cutaneous, intra-muscular, or intravenous.
  • Such a device could be operated by a subject or care-giver, such as a nurse or physician, and can include various types of safety syringe, pen-injector, or auto-injector.
  • the device can include a cartridge-based system that requires piercing a sealed ampule before use. Volumes of medicament delivered with these various devices can range from about 0.5 ml to about 2 ml.
  • the cam track 342 further includes an angled portion 342B (also referred to herein as a “second portion”) that is angled with respect to the longitudinal axis of the injection device.
  • the angled portion 342B is configured to apply a rotation force to the rotatable collar when contacted by the shroud pin 340 during retraction of the needle shroud 318, i.e., to convert a force from the shroud pin 340 in the proximal direction into a torque on the rotatable collar 308. This may be achieved by a ramped surface of the cam track 342.
  • the second trace 504 maintains a relatively flat profile throughout the retraction of the needle shroud.
  • the initial user force required to retract the needle shroud is slightly increased with respect to the first trace 502, since the user has to overcome both the control spring and friction between the shroud pin and the edge of the cam track.
  • the user force required to cause rotation of the collar is significantly reduced due to the rotation force applied by the biased plunger via the toothed beams of the rear casing.
  • the maximum force i.e., the peak force
  • a shroud pin of the needle shroud is guided from an initial position to a hold position using the first portion and an angled/ramped portion of the cam track, the guiding causing the rotatable collar to rotate relative to an injection device body.
  • the rotation of the rotatable collar causes one or more collar recesses to align with the respective one or more teeth of the toothed beam, providing space for the toothed beams to flex outwards, thereby releasing the plunger.
  • drug or “medicament” are used synonymously herein and describe a pharmaceutical formulation containing one or more active pharmaceutical ingredients or pharmaceutically acceptable salts or solvates thereof, and optionally a pharmaceutically acceptable carrier.
  • An active pharmaceutical ingredient (“API”) in the broadest terms, is a chemical structure that has a biological effect on humans or animals. In pharmacology, a drug or medicament is used in the treatment, cure, prevention, or diagnosis of disease or used to otherwise enhance physical or mental well-being. A drug or medicament may be used for a limited duration, or on a regular basis for chronic disorders.
  • a drug or medicament can include at least one API, or combinations thereof, in various types of formulations, for the treatment of one or more diseases.
  • API may include small molecules having a molecular weight of 500 Da or less; polypeptides, peptides and proteins (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes); carbohydrates and polysaccharides; and nucleic acids, double or single stranded DNA (including naked and cDNA), RNA, antisense nucleic acids such as antisense DNA and RNA, small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids may be incorporated into molecular delivery systems such as vectors, plasmids, or liposomes. Mixtures of one or more drugs are also contemplated.
  • the drug or medicament may be contained in a primary package or “drug container” adapted for use with a drug delivery device.
  • the drug container may be, e.g., a cartridge, syringe, reservoir, or other solid or flexible vessel configured to provide a suitable chamber for storage (e.g., short- or long-term storage) of one or more drugs.
  • the chamber may be designed to store a drug for at least one day (e.g., 1 to at least 30 days).
  • the chamber may be designed to store a drug for about 1 month to about 2 years. Storage may occur at room temperature (e.g., about 20°C), or refrigerated temperatures (e.g., from about - 4°C to about 4°C).
  • the drug container may be or may include a dual-chamber cartridge configured to store two or more components of the pharmaceutical formulation to-be-administered (e.g., an API and a diluent, or two different drugs) separately, one in each chamber.
  • the two chambers of the dual-chamber cartridge may be configured to allow mixing between the two or more components prior to and/or during dispensing into the human or animal body.
  • the two chambers may be configured such that they are in fluid communication with each other (e.g., by way of a conduit between the two chambers) and allow mixing of the two components when desired by a user prior to dispensing.
  • the two chambers may be configured to allow mixing as the components are being dispensed into the human or animal body.
  • the drugs or medicaments contained in the drug delivery devices as described herein can be used for the treatment and/or prophylaxis of many different types of medical disorders.
  • disorders include, e.g., diabetes mellitus or complications associated with diabetes mellitus such as diabetic retinopathy, thromboembolism disorders such as deep vein or pulmonary thromboembolism.
  • Further examples of disorders are acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and/or rheumatoid arthritis.
  • APIs and drugs are those as described in handbooks such as Rote Liste 2014, for example, without limitation, main groups 12 (anti-diabetic drugs) or 86 (oncology drugs), and Merck Index, 15th edition.
  • the term ..derivative refers to a polypeptide which has a molecular structure which formally can be derived from the structure of a naturally occurring peptide, for example that of human insulin, in which one or more organic substituent (e.g., a fatty acid) is bound to one or more of the amino acids.
  • one or more amino acids occurring in the naturally occurring peptide may have been deleted and/or replaced by other amino acids, including non-codeable amino acids, or amino acids, including non-codeable, have been added to the naturally occurring peptide.
  • insulin analogues examples include Gly(A21), Arg(B31), Arg(B32) human insulin (insulin glargine); Lys(B3), Glu(B29) human insulin (insulin glulisine); Lys(B28), Pro(B29) human insulin (insulin lispro); Asp(B28) human insulin (insulin aspart); human insulin, wherein proline in position B28 is replaced by Asp, Lys, Leu, Vai or Ala and wherein in position B29 Lys may be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.
  • insulin derivatives are, for example. B29-N-myristoyl-des(B30) human insulin, Lys(B29) (N- tetradecanoyl)-des(B30) human insulin (insulin detemir, Levemir®); B29-N-palmitoyl-des(B30) human insulin; B29-N- myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoyl LysB28ProB29 human insulin; B28-N-palmitoyl- LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N- palmitoyl- ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-gamma-glutamyl)-des(B30) human insulin, B29-N-omega-carboxypentadecanoyl-gamma-L-g
  • GLP-1 , GLP-1 analogues and GLP-1 receptor agonists are, for example, Lixisenatide (Lyxumia®), Exenatide (Exendin-4, Byetta®, Bydureon®, a 39 amino acid peptide which is produced by the salivary glands of the Gila monster), Liraglutide (Victoza®), Semaglutide, Taspoglutide, Albiglutide (Syncria®), Dulaglutide (Trulicity®), rExendin-4, CJC-1134-PC, PB-1023, TTP-054, Langlenatide / HM-11260C (Efpeglenatide), HM-15211 , CM-3, GLP-1 Eligen, GRMD-0901 , NN-9423, NN-9709, NN- 9924, NN-9926, NN-9927, Nodexen, Viador-GLP-1 , CVX-096, ZYOG-1 , ZYD-1 ,
  • oligonucleotide is, for example: mipomersen sodium (Kynamro®), a cholesterol-reducing antisense therapeutic for the treatment of familial hypercholesterolemia or RG012 for the treatment of Alport syndrom.
  • DPP4 inhibitors are Linagliptin, Vildagliptin, Sitagliptin, Denagliptin, Saxagliptin, Berberine.
  • hormones include hypophysis hormones or hypothalamus hormones or regulatory active peptides and their antagonists, such as Gonadotropine (Follitropin, Lutropin, Choriongonadotropin, Menotropin), Somatropine (Somatropin), Desmopressin, Terlipressin, Gonadorelin, Triptorelin, Leuprorelin, Buserelin, Nafarelin, and Goserelin.
  • Gonadotropine Follitropin, Lutropin, Choriongonadotropin, Menotropin
  • Somatropine Somatropin
  • Desmopressin Terlipressin
  • Gonadorelin Triptorelin
  • Leuprorelin Buserelin
  • Nafarelin Nafarelin
  • Goserelin Goserelin.
  • polysaccharides include a glucosaminoglycane, a hyaluronic acid, a heparin, a low molecular weight heparin or an ultra-low molecular weight heparin or a derivative thereof, or a sulphated polysaccharide, e.g. a poly-sulphated form of the above-mentioned polysaccharides, and/or a pharmaceutically acceptable salt thereof.
  • a pharmaceutically acceptable salt of a poly-sulphated low molecular weight heparin is enoxaparin sodium.
  • An example of a hyaluronic acid derivative is Hylan G-F 20 (Synvisc®), a sodium hyaluronate.
  • antibody refers to an immunoglobulin molecule or an antigenbinding portion thereof.
  • antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab')2 fragments, which retain the ability to bind antigen.
  • the antibody can be polyclonal, monoclonal, recombinant, chimeric, de-immunized or humanized, fully human, non-human, (e.g., murine), or single chain antibody.
  • the antibody has effector function and can fix complement.
  • the antibody has reduced or no ability to bind an Fc receptor.
  • the antibody can be an isotype or subtype, an antibody fragment or mutant, which does not support binding to an Fc receptor, e.g., it has a mutagenized or deleted Fc receptor binding region.
  • the term antibody also includes an antigen-binding molecule based on tetravalent bispecific tandem immunoglobulins (TBTI) and/or a dual variable region antibody-like binding protein having cross-over binding region orientation (CODV).
  • TBTI tetravalent bispecific tandem immunoglobulins
  • CODV cross-over binding region orientation
  • fragment refers to a polypeptide derived from an antibody polypeptide molecule (e.g., an antibody heavy and/or light chain polypeptide) that does not comprise a full-length antibody polypeptide, but that still comprises at least a portion of a full-length antibody polypeptide that is capable of binding to an antigen.
  • Antibody fragments can comprise a cleaved portion of a full length antibody polypeptide, although the term is not limited to such cleaved fragments.
  • Antibody fragments that are useful in the present invention include, for example, Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments such as bispecific, trispecific, tetraspecific and multispecific antibodies (e.g., diabodies, triabodies, tetrabodies), monovalent or multivalent antibody fragments such as bivalent, trivalent, tetravalent and multivalent antibodies, minibodies, chelating recombinant antibodies, tribodies or bibodies, intrabodies, nanobodies, small modular immunopharmaceuticals (SMIP), binding-domain immunoglobulin fusion proteins, camelized antibodies, and VHH containing antibodies. Additional examples of antigenbinding antibody fragments are known in the art.
  • SMIP small modular immunopharmaceuticals
  • CDR complementarity-determining region
  • framework region refers to amino acid sequences within the variable region of both heavy and light chain polypeptides that are not CDR sequences, and are primarily responsible for maintaining correct positioning of the CDR sequences to permit antigen binding.
  • framework regions themselves typically do not directly participate in antigen binding, as is known in the art, certain residues within the framework regions of certain antibodies can directly participate in antigen binding or can affect the ability of one or more amino acids in CDRs to interact with antigen.
  • antibodies are anti PCSK-9 mAb (e.g., Alirocumab), anti IL-6 mAb (e.g., Sarilumab), and anti IL-4 mAb (e.g., Dupilumab).
  • PCSK-9 mAb e.g., Alirocumab
  • anti IL-6 mAb e.g., Sarilumab
  • anti IL-4 mAb e.g., Dupilumab
  • Pharmaceutically acceptable salts of any API described herein are also contemplated for use in a drug or medicament in a drug delivery device.
  • Pharmaceutically acceptable salts are for example acid addition salts and basic salts.
  • An example drug delivery device may involve a needle-based injection system as described in Table 1 of section 5.2 of ISO 11608-1 :2014(E). As described in ISO 11608- 1 :2014(E), needle-based injection systems may be broadly distinguished into multi-dose container systems and single-dose (with partial or full evacuation) container systems.
  • the container may be a replaceable container or an integrated non-replaceable container.
  • a multi-dose container system may involve a needle-based injection device with a replaceable container. In such a system, each container holds multiple doses, the size of which may be fixed or variable (pre-set by the user).
  • Another multi-dose container system may involve a needle-based injection device with an integrated non-replaceable container. In such a system, each container holds multiple doses, the size of which may be fixed or variable (pre-set by the user).
  • a single-dose container system may involve a needle-based injection device with a replaceable container.
  • each container holds a single dose, whereby the entire deliverable volume is expelled (full evacuation).
  • each container holds a single dose, whereby a portion of the deliverable volume is expelled (partial evacuation).
  • a single-dose container system may involve a needlebased injection device with an integrated non-replaceable container.
  • each container holds a single dose, whereby the entire deliverable volume is expelled (full evacuation).
  • each container holds a single dose, whereby a portion of the deliverable volume is expelled (partial evacuation).

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

Abstract

La présente demande concerne un dispositif injecteur pour l'administration d'un médicament, en particulier un dispositif auto-injecteur. Selon un premier aspect de la présente invention, l'invention concerne un dispositif d'injection comprenant : un corps de dispositif d'injection ; un piston comprenant un ou plusieurs évidements de piston ; des moyens de sollicitation destinés à appliquer une force de sollicitation afin de solliciter le piston dans un sens distal du dispositif ; un boîtier entourant au moins partiellement le piston, le boîtier comprenant un ou plusieurs profilés dentés comprenant chacun une dent pouvant venir en prise avec un évidement de piston correspondant du ou des évidements de piston ; et un collier rotatif entourant au moins partiellement le boîtier et comprenant un ou plusieurs évidements de collier sur une surface interne du collier rotatif. Chacun du ou des évidements de piston est façonné afin de pousser une dent du profilé denté correspondant vers l'extérieur lorsque la force de sollicitation est appliquée au piston dans une configuration de préutilisation. Le ou les évidements de collier sont façonnés afin de coopérer avec une dent d'un profilé denté correspondant afin d'appliquer un couple au collier rotatif lorsque le profilé denté correspondant est poussé vers l'extérieur dans la configuration de préutilisation.
PCT/US2025/021782 2024-03-28 2025-03-27 Collier rotatif pour dispositifs d'injection Pending WO2025207902A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US18/620,210 US12274866B1 (en) 2024-03-28 2024-03-28 Rotatable collar for injection devices
US18/620,210 2024-03-28
EP24167305 2024-03-28
EP24167305.2 2024-03-28

Publications (1)

Publication Number Publication Date
WO2025207902A1 true WO2025207902A1 (fr) 2025-10-02

Family

ID=95395075

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2025/021782 Pending WO2025207902A1 (fr) 2024-03-28 2025-03-27 Collier rotatif pour dispositifs d'injection

Country Status (1)

Country Link
WO (1) WO2025207902A1 (fr)

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20170239427A1 (en) * 2014-08-10 2017-08-24 Antares Pharma, Inc. A syringe shock absorber for use in an injection device
US20210093796A1 (en) * 2019-09-30 2021-04-01 Amgen Inc. Drug delivery device
WO2023151957A1 (fr) * 2022-02-09 2023-08-17 Shl Medical Ag Système de rotation pour dispositif d'administration de médicament
US20230338662A1 (en) * 2020-02-24 2023-10-26 Shl Medical Ag Sub-assembly for medicament delivery device, and medicament delivery device comprising the sub-assembly

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20170239427A1 (en) * 2014-08-10 2017-08-24 Antares Pharma, Inc. A syringe shock absorber for use in an injection device
US20210093796A1 (en) * 2019-09-30 2021-04-01 Amgen Inc. Drug delivery device
US20230338662A1 (en) * 2020-02-24 2023-10-26 Shl Medical Ag Sub-assembly for medicament delivery device, and medicament delivery device comprising the sub-assembly
WO2023151957A1 (fr) * 2022-02-09 2023-08-17 Shl Medical Ag Système de rotation pour dispositif d'administration de médicament

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