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WO2025195799A1 - Sous-ensemble d'un dispositif d'administration de médicament - Google Patents

Sous-ensemble d'un dispositif d'administration de médicament

Info

Publication number
WO2025195799A1
WO2025195799A1 PCT/EP2025/056240 EP2025056240W WO2025195799A1 WO 2025195799 A1 WO2025195799 A1 WO 2025195799A1 EP 2025056240 W EP2025056240 W EP 2025056240W WO 2025195799 A1 WO2025195799 A1 WO 2025195799A1
Authority
WO
WIPO (PCT)
Prior art keywords
spring
sub
spring sleeve
plunger rod
actuator
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/EP2025/056240
Other languages
English (en)
Inventor
Thad MILEY
Iskender Okan ATES
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.)
SHL Medical AG
Original Assignee
SHL Medical AG
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 SHL Medical AG filed Critical SHL Medical AG
Publication of WO2025195799A1 publication Critical patent/WO2025195799A1/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
    • A61M5/20—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
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M2005/206—With 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
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M2005/2073—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically preventing premature release, e.g. by making use of a safety lock
    • A61M2005/208—Release is possible only when device is pushed against the skin, e.g. using a trigger which is blocked or inactive when the device is not pushed against the skin
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/581—Means for facilitating use, e.g. by people with impaired vision by audible feedback
    • 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
    • A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/31566—Means improving security or handling thereof
    • A61M5/3157—Means providing feedback signals when administration is completed
    • 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

Definitions

  • Medicament delivery devices such as pen-type manual injectors or auto-injectors are generally known for the self-administration of a medicament by patients without formal medical training.
  • patients suffering from diabetes may require repeated injections of insulin, or patients may require regular injections of other types of medicaments, such as growth hormones.
  • the medicament delivery devices for self-administration comprise automatic functions so that even if users are without professional training or are in an emergency, the users can easily and properly use the medicament delivery devices.
  • distal direction refers to the direction pointing away from the dose delivery site during the use of the medicament delivery device.
  • distal part/end refers to the part/end of the delivery device, or the parts/ends of the members thereof, which under use of the medicament delivery device is/are located furthest away from the dose delivery site.
  • proximal direction refers to the direction pointing towards the dose delivery site during the use of the medicament delivery device.
  • proximal part/end this refers to the part/end of the delivery device, or the parts/ends of the members thereof, which under use of the medicament delivery device is/are located closest to the dose delivery site.
  • longitudinal refers to a direction extending from the proximal end to the distal end, typically along the device or components thereof in the direction of the longest extension of the device and/or component.
  • transverse refers to a direction generally perpendicular to the longitudinal direction.
  • circumference refers to a circumference or a circumferential direction relative to an axis, typically a central axis extending in the direction of the longest extension of the device and/or component.
  • radial refers to a direction extending radially relative to the axis
  • rotation refers to rotation relative to the axis.
  • a sub-assembly of a medicament delivery device comprising: a spring being compressible along a longitudinal axis between a proximal end and a distal end; a spring sleeve comprising a distally directed surface engaged with the proximal end of the spring; and a shield positioned partially between the spring sleeve and the spring in a direction transverse to the longitudinal axis such that the shield is configured to prevent a movement of the spring sleeve along the longitudinal axis relative to the shield from being blocked by the spring.
  • the sub-assembly can prevent a movement of a functional component of a medicament delivery device on one radial side of the spring from being blocked by the spring coil.
  • the spring sleeve mentioned above is a functional component (the function is dependent on the design of the medicament delivery device. Some examples of the function of the spring sleeve will be explained in detail later).
  • the functional component means that a component that is directly involved in the operation of the medicament delivery device by an end user, e.g., such as involved in a delivery member penetration operation, and/or a medicament delivery operation, and/or the delivery member retraction operation, and/or a needle shield sleeve lockout operation. As the movement of the functional component is configured to provide the designed function of such component, it would be crucial to avoid the movement of the functional component being blocked.
  • a thickness of the shield is thinner than the spring sleeve and/or the spring coil.
  • a thickness of the shield is about 0.1-0.6mm.
  • the shield is made of metal or plastic.
  • the shield body is annular around the longitudinal axis.
  • the shield comprises a proximally directed surface engaged with the distal end of the spring.
  • the shield comprises a flange extending in the direction transverse to the longitudinal axis from a shield body.
  • the flange comprises the proximally directed surface.
  • the shield comprises a proximally extending wall extending from the flange towards the proximal end of the spring such that the spring is at least partially snuggly fitted between the shield body and the proximally extending wall.
  • the spring sleeve is movable along the longitudinal axis between a proximal position and a distal position.
  • the sub-assembly of the medicament delivery device comprises a drive mechanism comprising a power source.
  • the power source when the power source is released, the power source is configured to act on a medicament container within the medicament delivery device and force a contained medicament to be expelled via a medicament delivery member connected to the medicament container.
  • the power source can be released only when the spring sleeve is in the distal position.
  • the sub-assembly of the medicament delivery device comprises a user-accessible button.
  • the power source is configured to be released when the button is moved to the proximal position and the spring sleeve is in the distal position.
  • the drive mechanism comprises a plunger rod configured to be moved into the medicament container.
  • the power source is a plunger rod spring engaged with the plunger rod.
  • the plunger rod spring is configured to move the plunger rod into the medicament container when the plunger rod spring is released.
  • the drive mechanism comprises the spring sleeve.
  • the spring sleeve when the spring sleeve is in the proximal position the spring sleeve is coupled to the plunger rod such that the plunger rod is axially immovable relative to the spring sleeve.
  • the spring sleeve is configured to provide the function of retaining or releasing the plunger rod.
  • the drive mechanism comprises an actuator comprising a radially flexible arm.
  • the actuator is at least partially positioned within the spring sleeve when the spring sleeve is in the proximal position such that the flexible arm is blocked by the spring sleeve from radially moving outward relative to the longitudinal axis.
  • the flexible arm of the actuator is engaged with the plunger rod when the spring sleeve is in the proximal position.
  • the flexible arm of the actuator is movable between an engaging position where the flexible arm is engaged with the plunger rod and a disengaged position where the flexible arm is disengaged from the plunger rod.
  • the arm of the actuator when the spring sleeve is in the distal position the arm of the actuator is moved from the engaged position to the disengaged position.
  • the user-accessible button is operably connected to the actuator such that when the user-accessible button is moved to the proximal position the actuator is moved towards the proximal end of the spring by the user-accessible button.
  • the arm of the actuator when the spring sleeve is in the distal position and the user-accessible button is moved to the proximal position the arm of the actuator is moved from the engaged position to the disengaged position.
  • the spring sleeve can be a needle shield sleeve of a medicament delivery device.
  • the spring sleeve is configured to cover a delivery member of the medicament delivery device.
  • the spring at least partially surrounds the delivery member of the medicament delivery device.
  • the shield positioned partially between the spring sleeve and the spring in the direction transverse to the longitudinal axis such that the movement of the spring sleeve (namely that the needle shield sleeve, in this example) can be prevented from being blocked by the spring coil.
  • a medicament delivery device comprises a generally elongated tubular housing having opposite proximal and distal ends; a needle shield sleeve slidably and coaxially arranged inside the housing and protruding a distance outside the proximal end of the housing; a syringe carrier slidably and coaxially arranged to the needle shield sleeve, wherein said syringe carrier is configured to accommodate a medicament container having a medicament and a needle; the spring sleeve slidably and coaxially arranged to the housing and connected to said needle shield sleeve (at least when the needle shield sleeve is moved towards the spring sleeve); an actuator slidaby and coaxially arranged to the spring sleeve; an user-accessible button slidably and coaxially arranged to the distal end of the housing and fixedly connected to the actuator; wherein the spring sleeve and the user-accessible button are coaxial
  • the drive mechanism comprises the plunger rod arranged to act on the syringe and the power source arranged to drive the plunger.
  • the power source is a first compression spring.
  • the actuator comprises flexible tongues having annular inwardly directed ledges
  • the plunger rod comprises a circumferential groove having a mutual shape as that of the ledges so that the ledges fit into the groove.
  • the plunger is held against a force of the first compression spring by the inwardly directed ledges of the tongues of the actuator situated in the groove of the plunger rod, and by the spring sleeve which surrounds and prevents the tongues from moving radial outwards.
  • the generally elongated tubular housing comprises a distal housing part and a proximal housing part, wherein the distal housing part comprises an annular transversal wall having a through hole which has the shape of the distal part of the actuator, such that said distal part protrudes distally through said through hole until the distal surface of radial outwardly extending stop ledges of the actuator abuts against the proximal surface of the annular transversal wall.
  • the generally elongated tubular housing can be a single-piece component.
  • the distal surface of the radial outwardly extending stop ledges of the actuator is arranged to strike against the proximal surface of the annular transversal wall for giving an audible signal indicating that the delivery has been completed.
  • the spring sleeve When pressing the needle shield sleeve, which in turn is connected to the spring sleeve, against an injection site, the spring sleeve axially moves in relation to the actuator, but not so much that the drive mechanism is released.
  • the step of releasing the drive mechanism is then performed by the user- accessible button, for example a push button at the distal end of the device, which moves the actuator axially in relation to the spring sleeve until the drive mechanism, is released and thereby the plunger rod is released to act on a stopper within the syringe.
  • the medicament delivery device is further provided with a second compression spring that urges the needle shield to an extended position surrounding the needle when the needle shield is withdrawn from a medicament delivery site after an operation of the medicament delivery, and a locking mechanism for locking the needle shield in that extended position in order to avoid accidental needle sticks after injection and subsequently after disposal.
  • the device is provided with an audible signalling mechanism for giving a signal when an injection/delivery has been completed, whereby a remaining force from the first compression spring is used to distally move the actuator such that a part of it strikes against a part of the housing.
  • the device is provided with an audible signalling mechanism for giving a signal when an injection/delivery has been completed, whereby a remaining force from both the first compression spring and the second compression spring is used to distally move the actuator such that a part of it strikes against a part of the housing.
  • the device is provided with an audible signalling mechanism for giving a signal when an injection/delivery has been completed, whereby a remaining force from the second compression spring is used to distally move the actuator such that a part of it strikes against a part of the housing.
  • the medicament delivery device of any aspect of the presented invention comprises a single-chamber syringe.
  • the medicament delivery device of any aspect of the presented invention comprises a multiple-chamber syringe.
  • the barrel of the syringe is configured to accommodate the medicament to be delivered.
  • the syringe is made of glass material or plastic material.
  • the medicament delivery device of any aspect of the presented invention is an injection device, an inhalation device, or a medical sprayer.
  • the medicament delivery device of any aspect of the presented invention is an auto-injector.
  • the delivery member is an injection needle or a spray nozzle.
  • the medicament delivery devices described herein can be used for the treatment and/or prophylaxis of one or more of many different types of disorders.
  • exemplary disorders include, but are not limited to: rheumatoid arthritis, inflammatory bowel diseases (e.g. Crohn’s disease and ulcerative colitis), hypercholesterolaemia, diabetes (e.g. type 2 diabetes), psoriasis, migraines, multiple sclerosis, anaemia, lupus, atopic dermatitis, asthma, nasal polyps, acute hypoglycaemia, obesity, anaphylaxis and allergies.
  • Exemplary types of medicaments that could be included in the medicament delivery devices described herein include, but are not limited to, small molecules, hormones, cytokines, blood products, antibodies, antibody-drug conjugates, bispecific antibodies, proteins, fusion proteins, peptibodies, polypeptides, pegylated proteins, protein fragments, protein analogues, protein variants, protein precursors, chimeric antigen receptor T cell therapies, cell or gene therapies, oncolytic viruses, or immunotherapies and/or protein derivatives.
  • Exemplary medicaments that could be included in the medicament delivery devices described herein include, but are not limited to (with non-limiting examples of relevant disorders in brackets): etanercept (rheumatoid arthritis, inflammatory bowel diseases (e.g.
  • evolocumab hypercholesterolaemia
  • exenatide type 2 diabetes
  • secukinumab psoriasis
  • erenumab mimerase
  • alirocumab rheumatoid arthritis
  • methotrexate amethopterin
  • tocilizumab rheumatoid arthritis
  • interferon beta-1 a multiple sclerosis
  • sumatriptan miraines
  • adalimumab rheumatoid arthritis
  • darbepoetin alfa anaemia
  • sarilumab rheumatoid arthritis
  • semaglutide type 2 diabetes, obesity
  • dupilumab atopic dermatitis, asthma, nasal polyps, allergies
  • glucagon glucagon
  • ipilimumab nivolumab, pembrolizumab, atezolizumab, durvalumab, avelumab, cemiplimab, rituximab, trastuzumab, ado-trastuzumab emtansine, fam-trastuzumab deruxtecan-nxki, pertuzumab, transtuzumab-pertuzumab, alemtuzumab, belantamab mafodotin-blmf, bevacizumab, blinatumomab, brentuximab vedotin, cetuximab, daratumumab, elotuzumab, gemtuzumab ozogamicin, 90-Yttrium-ibritumomab tiuxetan, isatuximab
  • compositions including, but not limited to, any drug described herein are also contemplated for use in the medicament delivery devices described herein, for example, pharmaceutical formulations comprising a drug as listed herein (or a pharmaceutically acceptable salt of the drug) and a pharmaceutically acceptable carrier.
  • pharmaceutical formulations comprising a drug as listed herein (or a pharmaceutically acceptable salt of the drug) may include one or more other active ingredients, or may be the only active ingredient present.
  • Exemplary medicaments that could be included in the medicament delivery devices described herein include, but are not limited to, an immuno-oncology or bio-oncology medications such as immune checkpoints, cytokines, chemokines, clusters of differentiation, interleukins, integrins, growth factors, enzymes, signaling proteins, pro-apoptotic proteins, anti-apoptotic proteins, T-cell receptors, B-cell receptors, or costimulatory proteins.
  • an immuno-oncology or bio-oncology medications such as immune checkpoints, cytokines, chemokines, clusters of differentiation, interleukins, integrins, growth factors, enzymes, signaling proteins, pro-apoptotic proteins, anti-apoptotic proteins, T-cell receptors, B-cell receptors, or costimulatory proteins.
  • Exemplary medicaments that could be included in the medicament delivery devices described herein include, but are not limited to, those exhibiting a proposed mechanism of action, such as HER-2 receptor modulators, interleukin modulators, interferon modulators, CD38 modulators, CD22 modulators, CCR4 modulators, VEGF modulators, EGFR modulators, CD79b modulators, Trop-2 modulators, CD52 modulators, BCMA modulators, PDGFRA modulators, SLAMF7 modulators, PD-1/PD-L1 inhibitors/modulators, B-lymphocyte antigen CD19 inhibitors, B-lymphocyte antigen CD20 modulators, CD3 modulators, CTLA-4 inhibitors, TIM-3 modulators, VISTA modulators, INDO inhibitors, LAG3 (CD223) antagonists, CD276 antigen modulators, CD47 antagonists, CD30 modulators, CD73 modulators, CD66 modulators, CDw137 agonists, CD158 modulators, CD27 modulators, CD58 modulators, CD80 modulators, CD33 modulators
  • Exemplary medicaments that could be included in the medicament delivery devices described herein include, but are not limited to, a multi-medication treatment regimen such as AC, Dose-Dense AC, TCH, GT, EC, TAC, TC, TCHP, CMF, FOLFOX, mFOLFOX6, mFOLFOX7, FOLFCIS, CapeOx, FLOT, DCF, FOLFIRI, FOLFIRINOX, FOLFOXIRI, IROX, CHOP, R-CHOP, RCHOP-21 , Mini-CHOP, Maxi-CHOP, VR- CAP, Dose-Dense CHOP, EPOCH, Dose-Adjusted EPOCH, R-EPOCH, CODOX-M, IVAC, HyperCVAD, R-HyperCVAD, SC-EPOCH-RR, DHAP, ESHAP, GDP, ICE, MINE, CEPP, CDOP, GemOx, CEOP, CEPP, CHOEP, CHP, GCVP
  • Exemplary medicaments that could be included in the medicament delivery devices described herein include, but are not limited to, those used for chemotherapy, such as an alkylating agent, plant alkaloid, antitumor antibiotic, antimetabolite, or topoisomerase inhibitor, enzyme, retinoid, or corticosteroid.
  • chemotherapy such as an alkylating agent, plant alkaloid, antitumor antibiotic, antimetabolite, or topoisomerase inhibitor, enzyme, retinoid, or corticosteroid.
  • Exemplary chemotherapy medicaments include, by way of example but not limitation, 5-fluorouracil, cisplatin, carboplatin, oxaliplatin, doxorubicin, daunorubicin, idarubicin, epirubicin, paclitaxel, docetaxel, cyclophosphamide, ifosfamide, azacitidine, decitabine, bendamustine, bleomycin, bortezomib, busulfan, cabazitaxel, carmustine, cladribine, cytarabine, dacarbazine, etoposide, fludarabine, gemcitabine, irinotecan, leucovorin, melphalan, methotrexate, pemetrexed, mitomycin, mitoxantrone, temsirolimus, topotecan, valrubicin, vincristine, vinblastine, or vinorelbine.
  • Fig. 1 shows a perspective view of the device comprised in the present disclosure
  • Fig. 2 shows a perspective view of the device without the elongated housing comprised in the present disclosure
  • Fig. 3 shows an exploded view of the distal part of the device comprised in the present disclosure
  • Fig. 4 shows an exploded view of the proximal part of the device comprised in the present disclosure
  • Fig. 5 shows a perspective is a cross-sectional side view of the embodiment of Fig. 1 ;
  • Fig. 6 shows a perspective is a cross-sectional side view of the embodiment of Fig. 1 in a plane taken 90° in relation to Fig. 1 ;
  • Fig. 7 is a cross-sectional side view of the embodiment of Fig. 1 in a plane taken 90° in relation to Fig. 1 ;
  • Fig. 8 is a cross-sectional side view of the embodiment of Fig. 1 ;
  • Fig. 9 is a cross-sectional side view of the embodiment of Fig. 1 when the needle shield has been activated
  • Fig. 10 is a cross-sectional side view of the embodiment of Fig. 1 in a plane taken 90° in relation to Fig. 1 , when the needle shield has been activated;
  • Fig. 11 is a cross-sectional side view of the embodiment of Fig. 1 , when the push button has been activated;
  • Fig. 12 is a cross-sectional side view of the embodiment of Fig. 1 in a plane taken 90° in relation to Fig. 1 , when the push button has been activated;
  • Fig. 13 is a cross-sectional side view of the embodiment of Fig. 1 in a plane taken 90° in relation to Fig. 1 , when both the needle shield and the push button have been activated;
  • Fig. 14 is a cross-sectional side view of the embodiment of Fig. 1 , when both the needle shield and the push button have been activated;
  • Fig. 15 is a cross-sectional side view of the embodiment of Fig. 1 , after an injection has been performed;
  • Fig. 16 is a cross-sectional side view of the embodiment of Fig. 1 in a plane taken 90° in relation to Fig. 1 , after an injection has been performed;
  • Fig. 17 shows a perspective view of a spring sleeve, a spring, and a shield of a sub-assembly of the invention
  • Fig. 18 shows a perspective view of the sub-assembly of the invention in another embedment
  • Fig. 19 shows a cross-section view of the sub-assembly of Fig. 17;
  • Figs 20-21 show perspective view of the sub-assembly of Fig. 17;
  • Fig. 22 shows a cross-section view of the sub-assembly of Fig. 18.
  • Figs 1-22 illustrate a sub-assembly of a medicament delivery device and a medicament delivery device comprising the sub-assembly.
  • the sub-assembly comprises a spring 122 being compressible along a longitudinal axis L between a proximal end and a distal end; a spring sleeve 110 comprising a distally directed surface engaged with the proximal end of the spring 122; and a shield 5; 5’ positioned partially between the spring sleeve 110 and the spring 122 in a direction transverse to the longitudinal axis L such that the shield 5; 5’ is configured to prevent a movement of the spring sleeve 110 along the longitudinal axis L relative to the shield 5; 5’ from being blocked by the spring 122.
  • the shield 5; 5’ is thin, e.g., the thinnest component of the medicament delivery device.
  • the shield 5; 5’ is made of metal such that the shield can be easily formed as a thin component.
  • the medicament delivery device with the sub-assembly is more suitable to be assembled by a fullautomatic assembling machine. It is common that the full-automatic assembling machines are designed to bundle multiple machines providing multiple functions respectively to be one main machines. Usually, the full-automatic assembling machine comprises multiple material input ports to receive different materials/components respectively and a main output port to deliver assembled devices/sub-assemblies.
  • a medicament delivery device formed by a rear sub-assembly and a front sub-assembly such that the medicament can be positioned between the rear sub-assembly and the front sub-assembly in a manufacturing site that is closer to the market of the medicament delivery device.
  • the both the rear sub-assembly and the front sub-assembly can be assembled by the full-automatic assembling machine.
  • the full-automatic assembling machine comprises a spring winding function, namely that by providing a roll of metal wire, the full-automatic assembling machine can wind the metal wire to a spring with a predetermined number of coils.
  • the process of making the spring might cause the spring to have uneven diameters among coils, e.g., by an induction heating process.
  • some of the spring coils might block a movement of a functional component of the medicament delivery device.
  • the product containing a spring having the spring coils being able to block any movement of any functional component of the medicament delivery device can easily be detected between two stations or two manual steps.
  • the full-automatic assembling machine is designed to output a fully packed device or a sub-assembly packed with multiple components, most of time, the spring is invisible in the output products of the full-automatic assembling machine. Thus, it is hard and costly to detect an output product of the full-automatic assembling machine that contains a spring having the spring coils being able to block any movement of any functional component of the medicament delivery device.
  • the sub-assembly of the present disclosure provides the thin shield 5; 5’ positioned between the spring 122 and the spring sleeve 110; thus, the shield 5; 5’ prevents the movement of the spring sleeve 110 from being blocked by the uneven spring coils.
  • the shield 5 comprises a proximally directed surface 51a engaged with the distal end of the spring 122.
  • the shield 5; 5’ comprises a flange 51 ; 51 ’ extending in the direction transverse to the longitudinal axis L from a shield body 50; 50’.
  • the flange 51 ; 5T comprises the proximally directed surface 51a.
  • the shield 5’ comprises a proximally extending wall 52’ extending from the flange 5T towards the proximal end of the spring 122 such that the spring 122 is at least partially snuggly fitted between the shield body 50’ and the proximally extending wall 52’, as shown in Fig. 22.
  • the proximally directed surface 51a of the shield is configured to support the distal end edge of a distal- most coil of the spring 122. As a result, the distal end edge of the distal-most coil of the spring 122 can be prevented from being accidentally bent.
  • the shield 5’ comprises the proximally extending wall 52’ extending from the flange 51 ’ towards the proximal end of the spring 122
  • the shield body 50’ and the proximally extending wall 52’ are configured to support the spring from both radial sides.
  • the shield 5; 5’ is annular around the longitudinal axis L. Furthermore, as the spring is shielded from both lateral sides by the shield, movements of functional components on both lateral sides of the spring can be prevented from being blocked by the spring.
  • the shield 5; 5’ can be positioned at least partially within the spring sleeve. Alternatively, the shield 5; 5’ can be positioned at least partially within the spring 122.
  • the spring sleeve 110 is movable along the longitudinal axis L between a proximal position and a distal position.
  • the sub-assembly of the medicament delivery device comprises a drive mechanism P, as shown in Fig. 3, comprising a power source 63 (as shown in Fig. 19).
  • the power source 63 is released, the power source 63 is configured to act on a medicament container 16 within the medicament delivery device and force a contained medicament to be expelled via a medicament delivery member of the medicament delivery device.
  • the power source 63 can be released only when the spring sleeve 110 is in the distal position.
  • the sub-assembly of the medicament delivery device comprises a user-accessible button 1O2.
  • the power source 63 is configured to be released when the button 102 is moved to a proximal position relative to the spring sleeve 110 and the spring sleeve 110 is in the distal position.
  • the drive mechanism P comprises a plunger rod 60 configured to be moved into the medicament container 16.
  • the power source 63 is a plunger rod spring 63 engaged with the plunger rod 60.
  • the plunger rod spring 63 is configured to move the plunger rod 60 into the medicament container 16 when the plunger spring 63 is released.
  • the plunger rod spring 63 is positioned at least partially within the plunger rod 60 as shown in Fig. 19.
  • the plunger rod spring can partially enclose the plunger rod.
  • the power source can be pneumatic power source, e.g., a gas canister, a piezo pump, an electrochemical pump, a memory alloy, or a motor.
  • the drive mechanism P comprises the spring sleeve 110. When the spring sleeve 110 is in the proximal position the spring sleeve 110 is coupled to the plunger rod 60 such that the plunger rod 60 is axially immovable relative to the spring sleeve 110.
  • the drive mechanism P comprises an actuator 80 comprising a radially flexible arm 84.
  • the actuator 80 is at least partially positioned within the spring sleeve 110 when the spring sleeve 110 is in the proximal position such that the flexible arm 84 is blocked by the spring sleeve 110 from radially moving outward relative to the longitudinal axis L.
  • the flexible arm 84 of the actuator 80 is engaged with the plunger rod 60 when the spring sleeve 110 is in the proximal position.
  • the flexible arm 84 of the actuator 80 is movable between an engaging position where the flexible arm 84 is engaged with the plunger rod 60 and a disengaged position where the flexible arm 84 is disengaged from the plunger rod 60.
  • the flexible arm 84 comprises an inwardly directed ledge 86 configured to engage with a distally directed surface of the plunger rod 60.
  • the arm 84 of the actuator 80 is moved from the engaged position to the disengaged position.
  • the plunger rod 60 is moved towards the medicament container by the plunger rod spring 63.
  • the sub-assembly comprises the user-accessible button 102
  • the user-accessible button 102 is operably connected to the actuator 80 such that when the user-accessible button is moved to the proximal position the actuator 80 is moved towards the proximal end of the spring 122 by the user- accessible button 102.
  • the user-accessible button 102 is directly engaged with the actuator 80.
  • the user-accessible button is directly engaged with the plunge rod 60; in this example, as the plunger rod is engaged with the actuator, when the user manually moves the plunger rod in the proximal direction, the plunger rod drags the actuator to move in the proximal direction until the flexible arm of the actuator moves out from the spring sleeve.
  • the medicament delivery device comprises a generally elongated tubular housing 10, 12 having opposite proximal and distal ends.
  • a needle shield sleeve 20 is slidably and coaxially arranged inside the housing 10, 12 and protrudes a distance outside the proximal end of the housing 10, 12.
  • a syringe carrier 36 is slidable and coaxial to the needle shield sleeve 20.
  • the syringe carrier 36 is configured to accommodate the medicament container 16, e.g., a syringe 16 having a medicament and a medicament delivery member, e.g., a needle.
  • the spring sleeve 110 is slidably and coaxially arranged to the housing 10, 12 and connected to the needle shield sleeve 20.
  • the medicament delivery device further comprises the actuator 80 slidable and coaxial to the spring sleeve 110.
  • the user-accessible button 102 is slidable and coaxial arranged to the distal end of the housing 10, 12 and operably connected to the actuator 80.
  • the elongated housing 10, 12 comprises a proximal housing part 12 and a distal housing part 10.
  • an elongated opening 14 is arranged in a wall of the proximal housing part 12 such that the medicament can be viewed from the outside of the housing 10, 12.
  • the distal end of the proximal housing part 12 comprises an engagement member, e.g., as an annular recess on its inner surface adapted to interface with corresponding engagement member on e.g. the proximal outer surface of the distal housing part 10.
  • the housing can be one single component.
  • the needle shield sleeve 20 as shown in Fig. 2 and Fig. 4, comprises a first proximal part 22 having a certain diameter and a second distal part 24 having a diameter larger than the proximal part, where these parts are joined by an intermediate conical part 26.
  • an elongated slot 28 extends along the needle shield sleeve 20 for viewing the medicament, Fig. 2.
  • a circumferential ledge 30 is arranged, Fig. 4.
  • an opening 32 is arranged at the distal end of the needle shield sleeve 20 arranged.
  • an inwardly projecting, flexible, tongues 34 extends into the opening 32, Fig. 4.
  • the syringe carrier 36 which is slidably and coaxially arranged inside the needle shield 20 has the form of a general tubular body, Fig. 4.
  • the proximal part of the syringe carrier is arranged with a neck portion 38 dimensioned narrower in the direction transverse to the longitudinal axis L relative to the rest the syringe carrier, Fig. 4.
  • a guide surface is provided adjacent the neck portion. The surface is configured to cooperate with corresponding shapes of the inner surface of the needle shield sleeve in order to obtain a stop mechanism against rotation of the syringe carrier relative the needle shield.
  • the distal end of the syringe carrier is arranged with two distally extending tongues 42, where each tongue is arranged with an opening 44 and an inwardly directed ledge on the distal edge of each opening, Fig. 4.
  • the syringe carrier is further arranged with radial inwardly directed flanges on its inner surface in order to obtain a space between the syringe carrier wall and a syringe to be placed inside.
  • the medicament delivery device further comprises a holding member 68, as shown in Fig. 3.
  • each tongue 78 is arranged with radial inwardly directed ledges 74, as shown in Fig. 6.
  • the spring sleeve 110 which is slidably and coaxially arranged to the housing 10, 12 and connected to the needle shield sleeve 20.
  • the spring sleeve 110 comprises a sleeve body.
  • the sleeve body is tubular shaped.
  • the sleeve body comprises a proximal end with a conical part ending in a ledge 114 on an outer surface of the sleeve body, Fig. 3.
  • a first annular ring 116 is arranged on the outer surface, Fig. 3.
  • a second annular ring 118 is also arranged a further distance from the ledge 114, Fig. 3.
  • the distal end of the spring sleeve 110 is arranged with a cut-out 120 of a generally rectangular shape. Further, the distal end of the spring sleeve 110 is also arranged with at least two oppositely arranged guide members 121 extending in the distal direction of the device, Fig. 3.
  • the actuator 80 which is slidaby and coaxially arranged to the spring sleeve 110 has a mainly tubular shape.
  • a number of longitudinally directed cut-outs 88 are arranged at the front part of the actuator so as to form flexible tongues 90, Fig. 3.
  • the proximal end of each flexible tongue 90 has an inclined transition surface 82 which meets with a flexible arm 84 with enlarged diameter, Fig. 3.
  • the inwardly directed ledge 86 is arranged on the inner surface adjacent the transition surface 82 .
  • the inwardly directed ledge 86 is annularly arranged around the longitudinal axis L.
  • the actuator 80 is also provided with a stop ledge 92 directed radially outwards from the outer surface of the actuator 80.
  • the widths of said stop ledge 92 correspond to the width of the cut-out 120 of the spring sleeve, Fig. 3.
  • the actuator is further provided with a ledge 91 directed radially outwards from the outer surface forming a longitudinally extending guide track 94.
  • the guide track is arranged to mate each guide member 121 of the spring sleeve, Fig. 3.
  • the actuator 80 is also provided with a transversal distal end wall 100 and with two distally extending engagement member 101.
  • the medicament delivery device comprises the plunger rod 60 arranged to act on a stopper of the syringe and a plunger rod spring 63 arranged to drive the plunger rod.
  • the plunger rod 60 is formed as a tube with an outer diameter somewhat smaller than the inner diameter of the syringe body to be used.
  • the plunger 60 is arranged with a circumferential groove 62 with a certain width.
  • the distally directed surface of the plunger rod 60 is defined at the edge of the groove 62.
  • the inwardly directed ledge 86 of the actuator 80 and the radial inwardly directed ledges 74 of the holding member fits into, Fig. 3.
  • the plunger rod spring is arranged to the plunger rod e.g. inside the plunger rod.
  • a guide rod 66 is arranged inside the first compression spring, Fig. 3.
  • the plunger rod spring can be a torsion spring or a band spring.
  • the user-accessible button 102 is arranged to be fixedly attached to the distally extending engagement member 101 of the actuator 80 by corresponding engagement member arranged on the inner surface of a transversal distal wall. Further, the user-accessible button has a distal portion protruding distally from the distal housing part.
  • the user-accessible button 102 also comprises a first tongues 104 and a second tongue 103 directed towards the proximal direction of the device.
  • the first tongue 104 has a radial inwardly extending ledge 105, Fig. 3.
  • the user-accessible button 102 comprises two first tongues and two second tongues.
  • the device further comprises a spring 122 coaxially arranged on the spring sleeve 110.
  • the proximal end of the spring 122 is positioned on the second annular ring 118 of the spring sleeve 110.
  • the distal end of the spring 122 is positioned on the proximal surface of the stop ledges 92 of the actuator 80, Fig. 2.
  • the distal end of the spring 122 is positioned on the proximally directed surface 51a of the shield 5; 5’, as shown in Figs 20-21.
  • the device also comprises interfacing member arranged on the inner surface of the distal housing part 10.
  • the interfacing means comprises an annular transversal wall 200 having a through hole 201 which has the shape of the distal part of the actuator 80, such that said distal part protrudes distally through said through hole 201 until the distal surface of the stop ledges 92 of the actuator abuts against the proximal surface of the annular transversal wall 200.
  • the shape of the through hole 201 allows also the guide members 121 of the spring sleeve to pass through.
  • the interfacing member further comprises at least two distally and longitudinally extending ledges 202 adjacent to the annular distal surface of the transversal wall 200, wherein each ledge comprises an inclination at its distal end. Also, in front of each ledge 202 and at a predetermined distance, a distally extending protrusion 203 protrudes from the distal surface of the annular transversal wall 200.
  • the plunger is held against the force of the plunger rod spring 63 by the inwardly directed ledges 86 of the flexible arm 84 of the actuator 80 situated in the groove 62 of the plunger 60, and by the spring sleeve 110 which surrounds and prevents the flexible arm 84 from moving radially outwards, Fig. 5. Further the ledges 74 of the holding member are also arranged in the groove 62, Fig. 6.
  • the medicament container 16, the syringe carrier 36, and the needle shield 20 are coaxially placed in the proximal housing part, such that a portion of the front end of the needle shield sleeve 20 projects proximally through the front end of the proximal housing part, Fig. 5.
  • the inwardly directed ledge on the distal edge of the opening 44 of the syringe carrier 36 pass the distal end surface of the annular ledge 72 of the holding member 68, and at the same time the tongue 34 of the needle shield sleeve 20 fits the distal surface of the ledge 114 of the spring sleeve 110, Fig. 7 and 8.
  • Each radial inwardly extending ledge 105 of the user-accessible button 102 abuts the ledge 91 of the actuator 80 and the proximal end of the first tongue 104 of the user-accessible button 102 abuts the inclined surface of the guide member 121 of the spring sleeve 110, Fig. 5.
  • the proximal surface of the second tongue 103 of the user-accessible button 102 faces the inclined surfaces of each longitudinally extending ledge 202 on the inner surface of the distal housing part and adjacent to the annular distal surface of the transversal wall 200, Fig. 7.
  • the spring sleeve 110 and the user-accessible button 102 are arranged to co-act independent of the sequence.
  • the power source can be released by the spring sleeve is firstly activated (the spring sleeve is moved to the distal position) and the user-accessible button is subsequently activated (the user-accessible button is moved to the proximal position).
  • the power source can be released by the user-accessible button 102 is firstly activated (being moved to the proximal position) and the spring sleeve is subsequently activated (being moved to the distal position).
  • the user-accessible button is pushed proximally, Figs. 11 and 12, the first tongue 104 of the user-accessible button 102 comes over the guide member121 of the spring sleeve 110.
  • the actuator is also proximally moved a distance “D” whereby a portion of the flexible arm 84 comes out from the surrounding of the spring sleeve 110, Fig. 12.
  • the inclined transition distal surface 82 of the actuator 80 rests against the proximal end surface of the ledge 114 of the spring sleeve 110, holding the distal surface of the of the stop ledge 92 of the actuator the distance “D” from the proximal surface of the annular transversal wall 200 of the distal housing part.
  • the ledge 74 of the holding member 68 are also moved out of the groove because the arms 78 of the holding member are no longer held in place by the flexible arm of the actuator 80.
  • the force of the plunger rod spring 63 urges the plunger rod 60 to push on the stopper of the medicament container 16. But because of the friction between the stopper and the medicament container wall and incompressibility of liquid in the syringe and the very small flow passage through the needle, the force will push proximally the syringe and the syringe carrier, and thereby the needle penetrates the skin of the patient. The penetration stops when the proximal surface of the syringe carrier surrounding the neck portion abuts a ledge arranged inside the needle shield.
  • the force from the plunger rod spring 63 now moves proximally the stopper inside the syringe and the liquid medicament is injected into the patient until the stopper reaches the inner proximal end of the syringe.
  • the tongue 90 is radially moved inwards.
  • the actuator is distally moved the distance “D” inside the spring sleeve, whereby the distal surface of the of the stop ledge 92 of the actuator 80 strikes against the proximal surface of the annular transversal wall 200 of the distal housing part giving an audible signal to the patient indicating that the delivery e.g. the medicament delivery operation has been completed and that the device can be safely removed from the injection site.
  • the audible signal can be generated regardless of the user-accessible button is pressed by the user as long as the medicament delivery operation is completed.
  • the user-accessible button is directly contact with the plunger rod.
  • the plunger rod 60 is released.
  • the medicament delivery operation will be completed with or without the user continuously pressing on the button to the proximal position.
  • the tongue 104 is arranged with a tapered proximal end having a chamfered surface.
  • the housing 10 comprises a narrower section lined up with the tongue 104 when the user-accessible button is not yet in the proximal position and offset from the tongue 104 when the user-accessible button is in the proximal position.
  • the tongue 104 will be pushed radially aside by the actuator.
  • the actuator is able to move distally and generate the audible signal.
  • the users might be encouraged to keep their thumb on the button during the entire medicament delivery operation process so that the when the actuator 80 strikes against the proximal surface of the annular transversal wall 200 of the distal housing part 10 the users can be provided with a tactile indication as a completed signal of the medicament delivery operation.
  • the force of the spring 122 pushes proximally the spring sleeve and thus the needle shield connected to it, whereby the needle shield is proximally pushed out of the front end of the proximal housing part and surrounds the needle.
  • the movement of the spring sleeve causes the flexible arm 84 of the actuator 80 to pass ribs 111 arranged on the inner surface of the spring sleeve, Fig 16. These ribs prevent any attempts to push the needle shield distally into the device because the ribs will abut the front end of the flexible arm 84 of the actuator 80. The needle shield is thus locked, which prevents unintentional needle sticks.
  • both the user-accessible button and thus the actuator as well as the needle shield sleeve and thus the spring sleeve in order to release the drive mechanism. If the user-accessible button is depressed but the needle shield is not pressed against an injection site, then the penetration and injection action is not released. Also, if the needle shield is pressed against an injection site but the user-accessible button is not depressed, then the penetration and injection action is not released.
  • the housing of the medicament delivery device may be provided with (i.e., molded in, molded with) a compound featuring persistently antimicrobial, antifungal, and/or antiviral properties.
  • a compound featuring persistently antimicrobial, antifungal, and/or antiviral properties may be applied to the molded (i.e., finished) components through secondary processes (e.g., chemical vapor deposition), spraying, or dipping processes.

Landscapes

  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (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 sous-ensemble d'un dispositif d'administration de médicament, le sous-ensemble comprenant : un ressort compressible le long d'un axe longitudinal entre une extrémité proximale et une extrémité distale ; un manchon de ressort comprenant une surface dirigée de manière distale en prise avec l'extrémité proximale du ressort ; et un blindage positionné partiellement entre le manchon de ressort et le ressort dans une direction transversale à l'axe longitudinal de telle sorte que le blindage est conçu pour empêcher le blocage par le ressort d'un mouvement du manchon de ressort sur l'axe longitudinal par rapport au blindage.
PCT/EP2025/056240 2024-03-22 2025-03-07 Sous-ensemble d'un dispositif d'administration de médicament Pending WO2025195799A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US202463568476P 2024-03-22 2024-03-22
US63/568,476 2024-03-22
EP24178487.5 2024-05-28
EP24178487 2024-05-28

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Publication Number Publication Date
WO2025195799A1 true WO2025195799A1 (fr) 2025-09-25

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3011989B1 (fr) * 2009-07-07 2020-05-06 SHL Medical AG Dispositif d'injection
US20210268190A1 (en) * 2018-07-20 2021-09-02 Shl Medical Ag Medicament delivery device

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3011989B1 (fr) * 2009-07-07 2020-05-06 SHL Medical AG Dispositif d'injection
US20210268190A1 (en) * 2018-07-20 2021-09-02 Shl Medical Ag Medicament delivery device

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