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WO2025071724A1 - Avancement d'aiguille de précision - Google Patents

Avancement d'aiguille de précision Download PDF

Info

Publication number
WO2025071724A1
WO2025071724A1 PCT/US2024/037558 US2024037558W WO2025071724A1 WO 2025071724 A1 WO2025071724 A1 WO 2025071724A1 US 2024037558 W US2024037558 W US 2024037558W WO 2025071724 A1 WO2025071724 A1 WO 2025071724A1
Authority
WO
WIPO (PCT)
Prior art keywords
connector body
rotary knob
injection device
cap
rotary
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/US2024/037558
Other languages
English (en)
Inventor
Anu PRABHATHACHANDRAN
Jason J. Fink
Menachem PERETZ
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.)
West Pharmaceutical Services Inc
Original Assignee
West Pharmaceutical Services Inc
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 West Pharmaceutical Services Inc filed Critical West Pharmaceutical Services Inc
Publication of WO2025071724A1 publication Critical patent/WO2025071724A1/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
    • A61M5/31—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
    • A61M5/3287—Accessories for bringing the needle into the body; Automatic needle insertion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting in contact-lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/0008—Introducing ophthalmic products into the ocular cavity or retaining products therein
    • 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
    • A61M5/46—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 having means for controlling depth of insertion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting in contact-lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F2009/0035—Devices for immobilising a patient's head with respect to the instrument
    • A61F2009/0043—Devices for immobilising a patient's head with respect to the instrument by supporting the instrument on the patient's head, e.g. head bands
    • A61F2009/0052—Devices for immobilising a patient's head with respect to the instrument by supporting the instrument on the patient's head, e.g. head bands the instrument being supported on the patient's eye
    • 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
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/06—Head
    • A61M2210/0612—Eyes

Definitions

  • This disclosure relates generally to methods and systems for penetration devices with medical applications, and more particularly direct to systems and methods for precise needle advancement into an injection site.
  • Penetration devices such as needles are often used to inject medicine into or drain bodily cavities.
  • the suprachoroidal space (SCS) has been explored as a potential site for drug delivery to target the posterior segment of the eye.
  • the posterior segment has several associated diseases that benefit from drug treatment, and drug delivery via the SCS has been shown to be more effective than direct intravitreal injections to the posterior segment.
  • the present inventors recognize that issues arise when the individual using a needle is unable to confirm the needle's entrance into a cavity. Solid precise access to micrometerscale tissue layers using needles is a challenging problem in precision delivery of drugs, such as to the SCS. Determining needle entrance to tissue is critical to the success of the drug treatment, and manual advancement of the needle into sub-millimeter tissue layers while stabilizing the injection is very difficult based on tissue resistance feed-back alone.
  • An aspect of the present disclosure is directed to an injection device having: a connector body configured to be releasably attached to a syringe; a needle attached to a needle hub; and a rotary knob configured to be rotated relative to the connector body to advance and/or retract the needle hub.
  • the injection device may include one or more of the following features.
  • the rotary knob may be configured to advance and/or retract the needle hub in discrete steps.
  • the injection device may further include at least one pin connecting the needle hub and the rotary knob, wherein the rotary knob includes at least one rotary slot receiving the at least one pin, and the at least one pin rotationally fixes the needle hub relative to connector body.
  • the at least one rotary slot may include a distal surface forming a plurality of steps to enable the needle hub to be advanced and/or retracted in discrete steps.
  • the plurality of steps may be connected with angled surfaces to allow for retraction of the needle.
  • the injection device may further include a spring configured to bias the at least pin distally in the at least one rotary slot.
  • the injection device may further include a sleeve received in a lumen of the spring, wherein the sleeve has a distal surface disposed between the spring and the at least one pin.
  • the rotary knob may include a flexible arm having a radial protrusion, the connector body includes a flange having a plurality of radial grooves, and the radial protrusion is received in one of the plurality of radial grooves for each of discrete steps.
  • the connector body may be longitudinally fixed to the rotary knob.
  • the injection device may further include at least one locking member, wherein the connector body includes a flange, and the at least one locking member engages the flange to prevent proximal withdrawal of the connector body from the rotary knob.
  • the connector body may have a proximal portion including a first Luer connector configured to releasably attach to a second Luer connector on a distal portion of the syringe.
  • the connector body may include a lumen configured to receive a tip on a distal portion of the syringe, and the rotary knob may include a lumen configured to receive the distal portion of the syringe.
  • the injection device may include an elastomeric ring between the needle hub and the connector body.
  • the injection device may include a cap disposed over a distal portion of the rotary knob.
  • the cap may be configured to be rotationally fixed to the rotary knob when attached, such that rotation of the cap rotates the rotary knob.
  • the cap may include at least one projection, and the rotary knob may include at least one aperture configured to receive the at least one projection to rotationally fix the cap to the rotary knob.
  • the cap may have a first position where the at least one projection extends through the at least one aperture and into at least one channel of the connector body, rotationally fixing the cap, the rotary knob, and the connector body, and the cap may have a second position where the at least one projection extends through the at least one aperture rotationally fixing the cap and the rotary knob and allowing relative rotation of the cap with respect to the connector body.
  • the first position may be defined by an inner rib or groove of the cap being engaged with a first groove or rib of the connector body
  • the second position may be defined by the inner rib or groove of the cap being engaged with a second groove or
  • Another aspect of the present disclosure is directed to a system including: the injection device; and a syringe releasably attachable to the injection device.
  • Yet another aspect of the present disclosure is directed to a method of assembling the injection device.
  • the method may include: fixing the needle to the needle hub; assembling the needle hub into the connector body; inserting the at least one rotary pin into the at least one rotary slot to rotationally fix the needle hub to the connector body; assembling the spring and the sleeve onto the connector body; assembling the connector body into the rotary knob; longitudinally fixing the connector body inside of the rotary knob; and assembling the cap onto the rotary knob.
  • FIG. 1 illustrates an isometric view of a system including a syringe and injection device puncturing tissue of an eye, according to the present disclosure.
  • FIG. 2 illustrates a cross-section view of the system puncturing the tissue of the eye of FIG. 1.
  • FIG. 3 illustrates an exploded view of the injection device of FIGS. 1 and 2.
  • FIG. 4 illustrates a cross-section view of the system of FIGS. 1-3.
  • FIG. 5 illustrates a partially transparent isometric view of the injection device of FIGS. 1-4.
  • FIG. 6 illustrates a longitudinal view of a connector body of the injection device of FIGS. 1-5.
  • FIG. 7 illustrates a side view of the injection system of FIGS. 1-6.
  • FIG. 8 illustrates a flow chart for a method of assembling the injection device of FIGS. 1-7.
  • the rotation may be controlled by a cap that may have a first position rotationally fixing the cap and the rotary knob with respect to the connector body, and a second position allowing relative rotation of the cap and the rotary knob with respect to the connector body.
  • a syringe may be attached to the injection device for injection of a medicament through the needle into the tissue and/or aspiration of a substance from the tissue through the needle.
  • the rotary knob may be turned back in the opposite direction to retract the needle and/or recapped to prevent inadvertent sticking.
  • the change in injection depth may be pre-set to a very precise distance increments, as small as in about 0.05 mm up to 0.2 mm increments, but not limited to this range and depends on the application and the tissue characteristics such as stiffness, thickness, etc.
  • the syringe barrel may be substantially tubular (e.g., cylindrical) having an inner surface extending along the longitudinal direction to define a chamber 108.
  • the chamber 108 may be configured to receive, store, and/or mix a medicament for dispensing through a distal opening of the syringe tip 104.
  • the syringe 100 may be filled with the medicament and packaged as a prefilled syringe ready to be used after unpackaging.
  • the medicament may include one or more of small molecules, biologies or biologicals not limited to peptide, protein or monoclonal antibodies, or antibody drug conjugates, gene therapies.
  • the medicament may be for viral vector-based gene therapies and not limited to adeno-viral, lentiviral or other carrier-based therapies such as Lipid Nanoparticle (LNP), microparticle, hydrogel, aqueous and non-aqueous vehicle-based therapies, and cell-based drug products.
  • LNP Lipid Nanoparticle
  • microparticle microparticle
  • hydrogel aqueous and non-aqueous vehicle-based therapies
  • cell-based drug products cell-based drug products.
  • the medicament may be distinct types of cells (CAR-T, neurons, retinal pigment epithelial cells, epidermal cells, fibroblasts, myoblasts, cardiomyoblasts, iPSCs, adipose derived stem cells, mesenchymal stem cells) or to their stage of differentiation or their source of production.
  • Cell-based drug products could also include exosomes, or other cell-derived drug products, extracellular matrix (ECM) and ECM components (laminin, collagen, heparin sulfate proteoglycans, actin) or cellular assemblies or aggregates, scaffolds and tissue engineered medicinal product.
  • ECM extracellular matrix
  • ECM components laminin, collagen, heparin sulfate proteoglycans, actin
  • the medicament may be Lucentis®, Eylea®, Eylea® HD, Syfovre®, Vabysmo®, RGX-314, Izervay®, Lytenava®, or Beovu® or ones in clinical pipeline such as Axitinib, RGX-314, ALK-001, AVD-104, ATSN-201, OPT-302.
  • the syringe body may be composed of a cyclic olefin polymer, such as Crystal Zenith® manufactured by Daikyo Seiko, Ltd.
  • the eye 300 is composed of a number of layers, including the sclera 302, the choroid 304, and the retina 306.
  • a suprachoroidal space (SCS) 308 is disposed between the sclera 302 and the choroid 304.
  • the present invention is directed to the injection of the medicant into a sub-anatomical space, such as the SCS 308 to achieve chorioretinal concentrations 10 times greater than with traditional intravitreal injections.
  • the injection may have retinal, choroidal, gene therapy, and/or ocular oncology applications.
  • the injection into the SCS 308 has the potential to mitigate impact on the anterior segment and thus reduce the rate of intraocular pressure (IOP) increase.
  • IOP intraocular pressure
  • the delivery system 10 is readily applicable to any number of injection and/or aspiration treatments, for example, where precise needle translation may be necessary and/or a differential tissue stiffness exists across adjacent layers.
  • the SCS 308 is a smaller space relative to the sclera 302 and some other portions of the eye 300, and accurately delivering a medicament dose into the SCS 308 is difficult.
  • An advantage of the aspects described throughout this application is the improved control of drug delivery into the desired location in the eye 300 via precise targeting of the SCS 308.
  • the injection device 200 may include a rotary knob 202, a connector body 204, a needle hub 206, a needle 208, and a cap 210.
  • the rotary knob 202 may be rotated relative to the connector body 204 to longitudinally translate the needle hub 206 relative to the connector body 204 to advance and/or retract the needle 208.
  • the rotary knob 202 may have a lumen 203 that receives the connector body 204.
  • the needle hub 206 may be received in a lumen 205 of the connector body 204, and the needle 208 may be fixed to the needle hub 206.
  • the needle hub 206 may have a lumen 207 in communication with the lumen 205 of the connector body 204.
  • the needle 208 may be fixed rotationally and longitudinally to the needle hub 206 inside of the lumen 207, for example, with an adhesive.
  • the connector body 204 may have a distal portion 212 having an aperture 214 through which the needle 208 may extend by rotation of the rotary knob 202.
  • the distal portion 212 end of the connector body 204 may extend distally out of the lumen
  • the distal portion 212 of the connector body 204 may be frustoconical to facilitate handling and/or contact with the skin.
  • the connector body 204 may have a flange 216 and a proximal portion 218 configured to releasably attach to the syringe body.
  • the rotary knob 202 may be rotated relative to the connector body 204 in discrete steps.
  • the rotary knob 202 may be part of a ratcheting assembly to facilitate movement of the rotary knob 202 in one rotational direction relative to the connector body
  • the rotary knob 202 may include a flexible arm 220 and the flange 216 of the connector body 204 may have an outer periphery with a plurality of radial grooves 222 defining teeth therebetween, as illustrated in FIG. 6.
  • the flexible arm 220 may have a fixed end attached to the rotary knob 202 and a free end with a radial protrusion 224 received in one of the radial grooves 222.
  • the flexible arm 220 may extend circumferentially around the longitudinal axis of the injection device 200 in a circumferential slot 221 through the thickness of the rotary knob 202.
  • Rotation of the rotary knob 202 relative to the connector body 204 may deflect the flexible arm 220 radially outward relative to the longitudinal axis, such that the radial protrusion 224 rides over the teeth between the radial grooves 222 on the outer surface of the flange 216.
  • the number of radial grooves 222 may correspond to the discrete steps of advancing the needle 208.
  • the injection device 200 may include any number of flexible arms 220 around the circumference of the rotary knob 202 and corresponding sets of radial grooves 222. A predetermined force may be required to radially deflect the flexible arm 220 to release the radial protrusion 224 from the radial grooves 222.
  • This predetermined force provides tactile feedback on the position of the rotary knob 202 and to avoid continuous rotation causing an uncontrolled extension and/or retraction of the needle 208.
  • the flexible arm 220 may, additionally or alternatively, be configured to generate an audible feedback of an elastic return force of the radial protrusion 224 contacting, for example, the inner surface of the radial grooves 222.
  • the radial protrusion 224 may provide a controlled rotation of the rotary knob 202 relative to the connector body 204 and extension and/or retraction of the needle 208 with feedback to the user.
  • At least one rotary pin 230 may extend from the needle hub 206 through the connector body 204 and into at least one rotary slot 232 in the rotary knob 202.
  • the at least one rotary pin 230 may rotationally fix the needle hub 206 to the connector body 204, and movement of the at least one rotary pin 230 in the at least one rotary slot 232 may allow the needle hub 206 to longitudinally translate through the lumen 205 of the connector body 204 for extension of the needle 208.
  • the connector body 204 may have at least one elongated channel 234 with a longitudinal length and a lateral length, where the longitudinal length is greater than the lateral length.
  • the longitudinal length may be 4 or 5 times a diameter of the at least rotary pin 230, and the lateral width may approximate the diameter of the at least one rotary pin 230.
  • the longitudinal length of the at least one elongated channel 234 may allow longitudinal translation of each rotary pin 230 relative to the connector body 204, and the lateral length of the at least one elongated channel 234 may prevent relative rotational movement of each rotary pin 230 relative to the connector body 204.
  • the at least one rotary pin 230 may be formed as a separate component from the needle hub 206, and the needle hub 206 may include at least one hub slot 236 configured to receive the at least rotary pin 230.
  • the at least one hub slot 236 may be sized to approximate the outer diameter of the at least one rotary pin 230 to fix the at least one rotary pin 230 to the at least one hub slot 236.
  • the at least one rotary pin 230 may be fixed inside of the needle hub 206 with an adhesive.
  • the at least one rotary pin 230 may be monolithically formed with the needle hub 206 as one-piece component, for example, through injection molding (obviating the at least one hub slot 236).
  • the at least one rotary pin 230 may include two rotary pins 230 on opposing lateral sides of the needle hub 206 and the needle 208.
  • the at least one hub slot 236 may include two hub slots 236 on opposing lateral sides of the needle hub 206, each receiving one of the rotary pins 230.
  • the at least one elongated channel 234 may include two elongated channels 234 on opposing lateral sides of the connector body 204, each receiving one of the rotary pins 230.
  • the at least one rotary channel 232 may include two rotary channels 232 on opposing lateral sides of the rotary knob 202.
  • a seal 238 may be disposed between the needle hub 206 and the connector body 204 to seal the lumen 205 of the connector body 204, and to allow the linear movement of the needle hub 206.
  • the seal 238 may be an elastomeric ring that is received in a circumferential channel 239 in the needle hub 206 and engage an inner surface of the connector body 204.
  • the at least one rotary slot 232 may have a variable longitudinal dimension around a circumference of the rotary knob 202 to guide a longitudinal translation of the at least one rotary pin 230 as the rotary knob 202 is rotated relative to the connector body 204.
  • the at least one rotary slot 232 may have a distal surface forming a plurality of steps to enable the needle hub 206 to be advanced and/or retracted in discrete increments.
  • a spring 240 may apply a biasing distal force to the at least one rotary pin 230 to abut the distal surface of the at least one rotary slot 232.
  • the spring 240 may be a helical coil spring.
  • a sleeve 242 may be positioned around the connector body 204 and be received in a lumen of the spring 240.
  • the sleeve 242 may have a transverse distal wall 244 in the form of a circumferential distal flange positioned between a distal portion of the spring 240 and the at least one rotary pin 230.
  • the spring 240 may be compressed between the flange 216 of the connector 204 and the distal wall 244 of the sleeve 242.
  • the distal wall 244 of the sleeve 242 may distribute the distal, extension force applied by the spring 240 to the at least one rotary pin 230.
  • the sleeve 242 may precisely slide and press the at least one rotary pin 230 so that the uneven structure of the spring 240 does not affect the force distributed to the at least one rotary pin 230.
  • the rotational position of the steps relative to the at least one rotary pin 230 may correspond with the rotational position of the radial protrusion 224 relative to the radial grooves 222 to perform the controlled stepped advancement of the needle 208.
  • the steps of the at least one rotary slot 232 may be rotationally joined by angled surfaces or ramps to allow the needle hub 206 to be retracted by rotation of the rotary knob 202 in an opposite direction against the bias of the spring 240. For example, by turning the rotary knob
  • the needle 208 may move out and increasing an effective length.
  • the movement of the rotary knob 202 may be in five identical steps, each step may advance the needle 208 increasing the effective length of the needle 208 by 0.1 mm.
  • the spring 240 may advance the at least one rotary pin 230 to a new step of the at least one rotary slot 232, and the spring 240 may continuously press the at least one rotary pin 230 on the step.
  • the needle hub 206 may thus advance to a height of the step, so the needle 208 exits to a new extent from the connector body 204 corresponding to the rotational position of the at least one rotary pin 230 relative to the steps.
  • the total outward movement of the needle 208 may be about 0.5 mm.
  • the movement of the needle may be exactly 0.015- mm.
  • the needle advancement in each step can be as low as 0.05mm up to 0.2mm, but not limited to this range and depends on the application and the tissue characteristics such as stiffness, thickness etc.
  • the rotary knob 202 may be rotated back clockwise to shorten the effective length of the needle 208 in identical steps.
  • the injection device 200 can only advance the needle 208 in the forward direction.
  • the connector body 204 may be longitudinally fixed inside of the rotary knob 202.
  • the connector body 204 may be inserted into the lumen 203 of the rotary knob 202 until a distal surface of the flange 216 engages a proximal surface of a rim 248 on the rotary knob 202, as illustrated in FIG. 4.
  • the rim 248 may be defined by a differential diameter between a wider proximal portion of the rotary knob 202 configured to receive the distal portion of the syringe body and a narrower distal portion configured to be covered by the cap 210.
  • At least one locking member 246 may engage a proximal surface of the flange 216 to prevent proximal withdrawal of the connector body 204 from the rotary knob 202.
  • the one locking member 246 may be at least one locking pin 246 inserted into a hole 250 of the rotary knob 202 into the lumen 203 of the rotary knob 202 to engage the flange 216.
  • Sufficient space and/or frictional contact may be provided between the locking member 246 and the rim 248 to allow rotation of the connector body 204 inside the lumen
  • the syringe 100 may be releasably attached to the injection device 200 through a rotary connection.
  • the injection device 200 may have a male Luer connector on the proximal portion 218 of the connector body 204 configured to engage a female Luer connector on the syringe tip 104.
  • the male Luer connector may include an outer thread on the proximal portion 218 of the connector body 204, and the female Luer connector may include an internal thread on the syringe tip 104, as illustrated in FIG. 4.
  • the connector body 204 may be attached to the syringe tip 104 with other releasable and/or fixed attachment mechanisms.
  • An inner portion of the syringe tip 104 may be inserted into the lumen 205 of the connector body 204 when connected to place the chamber 108 of the syringe body into fluid communication with the lumen 207 of the needle hub 206 and the needle 208.
  • the lumen 203 of the rotary knob 202 may receive the syringe tip 104 when connected to the connector body 204 for additional security.
  • the cap 210 may be releasably attached to the rotary knob 202 to enclose one or more of distal portion of one or more of the rotary knob 202, the connector body 204, and/or the needle 208.
  • the cap 210 may include one or more inner ribs 258 configured to be received in (e.g., be snapped into) one or more outer grooves 252, 253 on the rotary knob 202 to longitudinally secure the cap 210 to the rotary knob 202.
  • the one or more grooves 252, 253 may extend circumferentially around the rotary knob 202.
  • the cap 210 may include at least one projection 254 extending from a proximal portion, and the rotary knob 202 may include at least one aperture 256 in the rim 248 configured to receive the projection 254 to rotational fix the cap 210 to the rotary knob 202.
  • the cap 210 may include a plurality of (e.g., two) projections 254 and the rotary knob 202 may include the same number of apertures 256.
  • the at least one projection 254 may extend longitudinally to enable insertion into at least one aperture 256 when the cap 210 is received over the distal portion of the rotary knob 202.
  • the at least one projection 254 may be configured to extend into the lumen 203 of the rotary knob 202 and be received into at least one channel 226 (e.g., two channels 226) in the outer periphery of the flange 216 of the connector body 204, as illustrated in FIG. 6.
  • the cap 210 may have a first proximal position where the inner rib 258 is received in a first groove 252, as illustrated in FIG. 4.
  • the at least one projection 254 may extend through the at least one aperture 256 and into the at least one channel 226, rotationally fixing the cap 210, the rotary knob 202, and the connector body 204.
  • the rotational fixation allows the injection device 200 to be fastened to the syringe 100 through rotation which seals the connection between the connector body 204 and the syringe 100 with preload between the Luer threads.
  • the connection between the at least one projection 254, the at least one aperture 256, and into the at least one channel 226 when the cap 210 is in the first position enable the transfer of torque to preload these members, preventing unwanted rotation of the rotary knob 202 prior to the connector body 204 becoming fully secured on the syringe 100.
  • the cap 210 may have a second position distal of the first position where the inner rib 258 is received in a second groove 253. In the second position, the at least one projection 254 may still extend through the at least one aperture 256, rotationally fixing the cap 210 and the rotary knob 202.
  • the at least one projection 254 may be pulled distally of the at least one channel 226 allowing relative rotation between the cap 210/the rotary knob 202 and the connector body 204.
  • the second position of the cap 210 may allow for advancement of the needle 208 while the needle 208 is still capped, preventing inadvertent sticks or contamination.
  • the inner protrusion 258 on the cap 210 may instead be a groove, and the first and second grooves 252, 253 on the rotary knob 202 may instead be a protrusion.
  • the first position of the cap 210 may be defined by an inner rib or groove 258 of the cap 210 engaged with a first groove or rib 252 of the connector body 204
  • the second position of the cap 210 may be defined by the inner rib or groove 258 of the cap 210 engaged with a second groove or rib 253 of the connector body 204.
  • the cap 210 may then be removed from the rotary knob 202 for insertion of the needle 208 into tissue.
  • the rotary knob 202 may include an elongated slot or window (not shown) and the connector body 204 may include a plurality of indicia (e.g., numbers, not shown) indicating a depth of the needle 208, such that rotation of the rotary knob 202 relative to the connector body 204 may selectively reveal indicia indicating to the user the present depth of the needle 208.
  • indicia e.g., numbers, not shown
  • FIG. 8 illustrates a flow chart for a method 500 of assembling the injection device 200.
  • the needle 208 may be inserted into the lumen 207 of the needle hub 206 and fixed to the needle hub 206.
  • the needle 208 may be fixed to the needle hub 206, for example, with an adhesive.
  • the seal 238 may be assembled to the needle hub 206, for example, by being inserted into the circumferential channel 239.
  • the needle hub 206 may be inserted into the connector body 204. When inserted, the seal 238 may extend between the needle hub 206 and the connector body 204 to provide a fluid sealing interface.
  • the hub slot(s) 236 and the elongated channel(s) 234 may be aligned.
  • the alignment may be performed by a tool (not shown) being inserted into a slot (not shown) in a proximal portion of the needle hub 206.
  • the slot may have a linear or cross shape, and the tool may correspondingly have a flat head or Philips-head end effector to be able to rotate the needle hub 206 and/or the connector body 204 and facilitate the alignment.
  • the rotary pin(s) 230 may then be inserting into the elongated channel 234 and the hub slot 236 to rotationally fix the connector body 204 and the needle hub 206.
  • the spring 240 and the sleeve 242 may be assembled onto the connector body 204.
  • the spring 240 may be inserted over the sleeve 242 and abut the distal wall 244.
  • the connector body 204 may be inserted into a lumen of the sleeve 242, such that the spring 240 and the sleeve 242 are positioned on top of the rotary pin(s) 230 and the distal wall 244 of the sleeve 242 contacts the rotary pin(s) 230.
  • the connector body 204, the spring 240, and the sleeve 242 may be assembled into the lumen 203 of the rotary knob 202.
  • the connector body 204 may be inserted into the rotary knob 202 until the distal surface of the flange 216 engages the proximal surface of the rim 248 on the rotary knob 202.
  • the rotary pin(s) 230 may be inserted into the rotary channel(s) 232 to provide the rotary connection between the rotary knob 202 and the connector body 204.
  • the rotary pin(s) may be inserted into the hub slot(s) 236, the elongated channel(s) 234, and rotary channel(s) 232 simultaneously after the connector body 204 is assembled into the lumen 203 of the rotary knob 202.
  • the connector body 204 may be longitudinally fixed inside of the rotary knob 202.
  • the at least one locking pin 246 may be inserted into the rotary knob 202 to longitudinally fix the connector body 204 inside of the rotary knob 202.
  • the at least one locking pin 246 may be inserted into the hole 250 and contact the proximal portion of the flange 216.
  • the at least one locking pin 246 may allow rotation of the rotary knob 202 relative to the connector body 204 but prevent proximal retraction of the connector body 204.
  • the function of the at least one locking pin 246 may be replaced by other mechanisms, such as a snap fit.
  • the cap 210 may be assembled on to the rotary knob 202.
  • the projection(s) 254 may be inserted into the aperture(s) 256 and the channel(s) 226 to rotationally fix the cap 210, rotary knob 202, and the connector body 204 in the first position.
  • the cap 210 may be retracted into the second position and/or be removed during use.

Landscapes

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

Abstract

Un dispositif d'injection comprend un corps de connecteur fixé de manière amovible à une seringue, une aiguille fixée à une embase d'aiguille et un bouton rotatif. Le bouton rotatif tourne par rapport au corps de connecteur pour faire avancer et/ou rétracter l'embase d'aiguille. Le bouton rotatif peut être conçu pour faire avancer et/ou rétracter l'embase d'aiguille dans des étapes discrètes. Au moins une broche peut relier l'embase d'aiguille et le bouton rotatif, et le bouton rotatif peut comprendre au moins une fente rotative recevant l'au moins une broche, et l'au moins une broche peut fixer en rotation l'embase d'aiguille par rapport au corps de connecteur. Un système comprenant le dispositif d'injection et une seringue pouvant être fixée de manière amovible au dispositif d'injection est également décrit. Un procédé d'assemblage du dispositif d'injection est en outre décrit.
PCT/US2024/037558 2023-09-27 2024-07-11 Avancement d'aiguille de précision Pending WO2025071724A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202363540880P 2023-09-27 2023-09-27
US63/540,880 2023-09-27

Publications (1)

Publication Number Publication Date
WO2025071724A1 true WO2025071724A1 (fr) 2025-04-03

Family

ID=92106565

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2024/037558 Pending WO2025071724A1 (fr) 2023-09-27 2024-07-11 Avancement d'aiguille de précision

Country Status (1)

Country Link
WO (1) WO2025071724A1 (fr)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9180047B2 (en) * 2013-05-03 2015-11-10 Clearside Biomedical, Inc. Apparatus and methods for ocular injection
US20160296715A1 (en) * 2013-11-14 2016-10-13 Hahn-Schickard-Gesellschaft Fuer Angewandte Forschung E.V. Access device
US9656027B2 (en) * 2011-05-18 2017-05-23 Becton, Dickinson And Company Single-use injector of low cost
US20170266045A1 (en) * 2014-11-28 2017-09-21 Visionisti Oy Ocular therapeutics tool
US10973681B2 (en) * 2016-08-12 2021-04-13 Clearside Biomedical, Inc. Devices and methods for adjusting the insertion depth of a needle for medicament delivery

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9656027B2 (en) * 2011-05-18 2017-05-23 Becton, Dickinson And Company Single-use injector of low cost
US9180047B2 (en) * 2013-05-03 2015-11-10 Clearside Biomedical, Inc. Apparatus and methods for ocular injection
US20160296715A1 (en) * 2013-11-14 2016-10-13 Hahn-Schickard-Gesellschaft Fuer Angewandte Forschung E.V. Access device
US20170266045A1 (en) * 2014-11-28 2017-09-21 Visionisti Oy Ocular therapeutics tool
US10973681B2 (en) * 2016-08-12 2021-04-13 Clearside Biomedical, Inc. Devices and methods for adjusting the insertion depth of a needle for medicament delivery

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