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EP4395847A1 - Dispositifs, systèmes et procédés d'administration de substances injectables - Google Patents

Dispositifs, systèmes et procédés d'administration de substances injectables

Info

Publication number
EP4395847A1
EP4395847A1 EP22839570.3A EP22839570A EP4395847A1 EP 4395847 A1 EP4395847 A1 EP 4395847A1 EP 22839570 A EP22839570 A EP 22839570A EP 4395847 A1 EP4395847 A1 EP 4395847A1
Authority
EP
European Patent Office
Prior art keywords
delivery system
cover
transport
tubing
needle
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
EP22839570.3A
Other languages
German (de)
English (en)
Inventor
Patrick A. Haverkost
Joel N. Groff
David Raab
Scott Mcghee
Mark Steven Smith
Nachiket Gole
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.)
Boston Scientific Medical Device Ltd
Boston Scientific Scimed Inc
Original Assignee
Boston Scientific Medical Device Ltd
Boston Scientific Scimed 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 Boston Scientific Medical Device Ltd, Boston Scientific Scimed Inc filed Critical Boston Scientific Medical Device Ltd
Publication of EP4395847A1 publication Critical patent/EP4395847A1/fr
Pending legal-status Critical Current

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
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/1407—Infusion of two or more substances
    • A61M5/1409—Infusion of two or more substances in series, e.g. first substance passing through container holding second substance, e.g. reconstitution systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/16—Holders for containers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2096—Combination of a vial and a syringe for transferring or mixing their contents
    • G—PHYSICS
    • G21—NUCLEAR PHYSICS; NUCLEAR ENGINEERING
    • G21F—PROTECTION AGAINST X-RADIATION, GAMMA RADIATION, CORPUSCULAR RADIATION OR PARTICLE BOMBARDMENT; TREATING RADIOACTIVELY CONTAMINATED MATERIAL; DECONTAMINATION ARRANGEMENTS THEREFOR
    • G21F5/00—Transportable or portable shielded containers
    • G21F5/015—Transportable or portable shielded containers for storing radioactive sources, e.g. source carriers for irradiation units; Radioisotope containers

Definitions

  • the base is configured to permit ejection of the material transport device therefrom.
  • the material transport device is delivered already mounted in the cover.
  • the cover includes a priming system already mounted therein.
  • the material access device is shiftable between a position fluidly communicating with the priming system to be placed in an airless state, and a position fluidly communicating with the material transport device to deliver injectable material from the material transport device to a patient.
  • the material access device includes an inlet needle, an outlet needle, and a tubing system; and the material delivery system further includes a priming cap; wherein sharp ends of the inlet needle and the outlet needle extend into a chamber within the priming cap; and priming includes flushing a material through the inlet needle, through the chamber within the priming cap, through the outlet needle, and through the tubing system to eliminate air from within the material delivery system; and the method further includes retaining the material within the tubing system and removing the priming cap before mating the cover with the base to allow the sharp ends of the inlet needle and the outlet needle to extend into the material transport device to access the injectable material for delivery to a patient.
  • the method further includes delivering the material delivery system within the base to a medical facility at which the injectable material is to be delivered to the patient.
  • FIG. 2 illustrates a cross-sectional view along line II- II of FIG. 1.
  • FIG. 16 illustrates a perspective view of another example of an embodiment of a transport and delivery system, in a priming position / configuration.
  • proximal refers to the direction or location closest to the user (medical professional or clinician or technician or operator or physician, etc., such terms being used interchangeably herein without intent to limit, and including automated controller systems or otherwise), etc., such as when using a device (e.g., introducing the device into a patient, or during implantation, positioning, or delivery), and “distal” refers to the direction or location furthest from the user, such as when using the device (e.g., introducing the device into a patient, or during implantation, positioning, or delivery). “Longitudinal” means extending along the longer or larger dimension of an element.
  • the material access and delivery system includes delivery tubing or other delivery conduit(s) (for the sake of convenience, reference is made herein simply to delivery tubing, without intent to limit) through which the injectable material is conveyed to the patient.
  • Delivery tubing may be coupled directly or indirectly to other components of the material delivery system as may be readily appreciated by those of ordinary skill in the art.
  • the material delivery system may further include a material impelling system configured to draw, convey, impel, or otherwise direct (such terms being used interchangeably herein without intent to limit) the materials from within the material transport device into the delivery tubing.
  • the material access device may include a first needle and a second needle, inlet tubing coupled to the first needle (which may be alternately referenced as an inlet needle without intent to limit), and outlet tubing connected to the second needle (which may be alternately referenced as an outlet needle without intent to limit).
  • Sterile injectable fluid may be injected via the inlet tubing into the first needle to push material within the material transport device into the second needle and into the outlet tubing (which may alternatively be referenced as delivery tubing).
  • a liquid such as saline (e.g., sterile saline) or other fluids approved for intravenous or intraarterial injection may be injected to fluidize the solid particles, not only to deliver the solid particles from the material transport device but also to facilitate flow of the solid particles into the patient.
  • the material delivery system is configured to maintain the delivery tubing oriented to facilitate flow of the solid particles into a microcatheter for injection into the patient.
  • a catheter mounting arm or other structure configured to support or hold the outlet tubing in a downward orientation (negative angle from horizontal) towards the patient may be associated with the delivery system to facilitate flow of the solid particles and to prevent the solid particles from catching or otherwise becoming stuck, such as within the outlet tubing and/or manifold coupling the delivery tubing to the microcatheter, etc.
  • a microcatheter herein is to be understood to include catheters, microcatheters, neurocatheters, etc., the present disclosure not being limited by the size, dimension, etc., of the catheter.
  • the priming tool covers the sharp ends of a first needle and a second needle.
  • the priming tool may comprise a cap with a septum, the first and second needle piercing through the septum to be contained within a holding area within the priming tool.
  • Such holding area may be substantially sealed.
  • priming fluid may be injected into inlet tubing, through the first needle and into the holding area within the priming tool, from the holding area into the second needle, and then into outlet tubing. Flushing the material delivery system in such manner eliminates air and any other desired materials within the material delivery system.
  • a one-way valve is not be suitable for use with outlet tubing (e.g., if the injectable material includes particles which may catch or otherwise collect along a one-way valve and not be delivered to the patient), a finger clip or a cap (e.g., tethered to the outlet tubing) or another structure for pinching or closing the outlet tubing may be provided on the outlet tubing to maintain the material delivery system as an airless primed system.
  • references to “one embodiment,” “an embodiment,” “some embodiments”, “other embodiments”, etc. in various places in the specification are not necessarily all referring to the same embodiment, nor are separate or alternative embodiments necessarily mutually exclusive of other embodiments.
  • references to “one embodiment,” “an embodiment,” “some embodiments”, “other embodiments”, etc. in various places in the specification are not necessarily all referring to the same embodiment, nor are separate or alternative embodiments necessarily mutually exclusive of other embodiments.
  • the stopper may be formed of an elastomeric material (e.g., chlorobutyl rubber), so that a portion of the stopper 144 may be configured as a septum 143 which may be pierced (e.g., by a needle) to access and to deliver the injectable material from within the vial 142.
  • the septum 143 may be formed as a separate element (e.g., with the stopper including a rigid ring holding an elastomeric septum).
  • the material transport device 140 may further include a first container 146 in which the vial 142 may be positioned.
  • the first container 146 may be formed of a material which blocks radioactive emissions (e.g., beta or gamma particles), such as lead, tungsten, or stainless steel, and therefore may be considered a radioactive shield for the vial 142 if the injectable material therein is radioactive.
  • the first container 146 may be placed within a second container 148, such as to further protect the vial 142 as well as the first container 146.
  • the second container 148 may be formed from a polymer (generally more lightweight than the material of the first container 146), such as polystyrene and may be considered a shell.
  • all components of the material transport device 140 which block radioactive emissions may be formed from a tungsten- infused polymer, such as formed by suspending tungsten powder or particles in raw material polymer pellets and molding the material into the desired component of the material transport device 140.
  • components of or the entire material transport device 140 may be reusable once the radioactive material therein has passed its half-life.
  • an additional holding element 154 may be provided to hold the vial 142 within the first container 146.
  • the holding element 154 may be in the form of a metal wire or other low profile element configured to restrain the vial 142 from movement with respect to the first container 146.
  • the holding element 154 is insertable between the stopper 144 of the vial 142 and a shoulder 141 of the vial 142 below the stopper 144, and held with respect to the first container 146 by extending through an opening 145 in the first container 146.
  • the holding element 154 may further be held with respect to the second container 148 by extending within a groove 149 within the interior of the second container 148.
  • the holding element 154 is a U-shaped wire with the cross-portion (extending between the legs of the U- shape) extending into the groove 149 in the second container 148. It will be appreciated that in embodiments in which the material transportation device 140 is not removed from the base 110 after delivery of the contents thereof, then the holding element 154 may not be needed and may not be included.
  • the material transport device 140 is placed in a holder 112 within the base 110, as may be appreciated with reference to FIG. 2.
  • the holder 112 may be sized, shaped, configured, and dimensioned to securely contain the material transport device 140 therein.
  • the material transport device 140 is substantially immovable (e.g., can move less than at most about 0.1 mm) when within the holder 112.
  • the holder may be configured to facilitate removal of the material transport device 140 therefrom once the injectable material has been delivered to the patient.
  • an opening 113 is defined along the bottom the holder 112 through which a portion of the bottom of the material transport device 140 is accessible.
  • the medical professional may access the bottom of the material transport device 140 through the opening 113 to push the material transport device 140 out of the holder 112.
  • a holder cover 114 such as a rubber base, may be positioned over the opening 113 and may be sufficiently flexible to be pressed to push the material transport device 140 to eject the material transport device 140 out of the holder 112 (such as to allow insertion of another material transport device 140).
  • the holder cover 114 may also be suitable as a sterile barrier for the material transport device 140.
  • the base 110 may include an outer wall 116 to define a desired outer dimension and/or configuration of the base 110.
  • the base 110 may be manually held by the medical professional administering the injectable material from within the material transport device 140 to the patient.
  • the outer wall 116 may be sized, shaped, dimensioned, and configured to facilitate grasping within a medical professional’s hand, such as once mated with the cover 120.
  • the outer wall 116 may be round or rounded to facilitate grasping, such as in the example of an embodiment illustrated in FIG. 1. In other embodiments, such as illustrated in FIG. 6, FIG. 7, and FIG.
  • the base 110 may be set on a support surface, with the base 110 being sufficiently sized, shaped, dimensioned, and configured to provide sufficiently stability so the transport and delivery system 100 remains upright independently and is resistant to being knocked over or otherwise destabilized.
  • the base 110 may be configured to mate with the cover 120.
  • the outer wall 116 of the base 110 may be configured to mate with (e.g., receive) the cover 120 by having similar shapes.
  • the base 110 and the cover 120 may have engagement features for holding the base 110 and cover 120 in place with respect to each other. For instance, mating ribs, mating grooves and detents, or other engagement features may be provided on the base 110 and cover 120.
  • the cover 120 is mounted over the base 110 by being positioned over and being moved down onto the base 110.
  • engagement features e.g., axial ribs and/or engaging detents, shoulders, grooves, recesses, etc. as known to those of ordinary skill in the art, the present disclosure not being limited by a specific configuration
  • engagement features facilitate sliding axial movement between the base 110 and cover 120 to be mated together, and to be held together once positioned in their final positions with respect to each other, such as illustrated in FIG. 1 and FIG. 2. It will be appreciated that other configurations are within the scope and spirit of the present disclosure.
  • the base 110 and the cover 120 may be configured such that upon engagement of the cover 120 with the base 110, the tubing system 130 is fluidly coupled with the material transport device 140 configured to deliver injectable material from within the vial 142 to a patient, as may be appreciated with reference to FIG. 2. More particularly, mounting and engagement of the cover 120 with the base 110 aligns a material access device 160 within the cover 120 with the vial 142 in which the injectable material is contained.
  • the material access device 160 illustrated in FIG. 2 and FIG. 4 includes a needle (more particularly, a pair of needles 160a, 160b), or any other type of tubular element configured to access and convey the injectable material from the vial 142.
  • the material access device 160 may include a material access device clamshell 162 configured to hold the needles 160a, 160b.
  • the needles 160a, 160b are held in offset positions, such as to create a vortex upon priming the material delivery system (described in further detail below) and/or delivering injectable material.
  • the material access device clamshell 162 may be carried by a material access device holder 122 formed within the cover 120.
  • the material access device holder 122 includes at least two spring arms 122a, 122b configured to engage or mate with the exterior of the material access device clamshell 162.
  • spring arms similar to spring arms 122a, 122b, may be provided with detents or shoulders or may be otherwise formed (such as at the free ends 121a, 121b thereof) to lock into or below grooves or shoulders in the material access device clamshell 162 (see, e.g., shoulders 163 in FIG. 4) in a manner which may be appreciated by those of ordinary skill in the art.
  • a window 123 may be provided in the cover 120 or at least portions of cover 120 may be formed of a transparent / translucent material to allow viewing of the material access device 160 and the material transportation device 140 such as to view alignment and/or to assure there are no leaks.
  • Movement of the cover 120 towards the base 110 causes the material access device 160, particularly, the sharp ends 161a, 161b of the needles 160a, 160b of the material access device 160, to pierce the septum 143 of the stopper 144 to access the injectable material within the vial 142.
  • the delivery tubing 130a of the tubing system 130 is fluidly coupled with the material access device 160 (in particular, with the delivery needle 160a) so that once the material access device 160 is fluidly coupled with the interior of the vial 142, the injectable material may be delivered to the delivery tubing 130a for delivery to a patient.
  • a mounting arm 170 may be provided on the cover 120, as illustrated in FIG. 1 and FIG. 2.
  • the mounting arm 170 may be a strut or other structure configured to maintain the delivery tubing 130a in a desired orientation.
  • the mounting arm 170 may be configured to hold the delivery end 133 of the delivery tubing 130a in a downward, nonhorizontal orientation (e.g., at least about -35° with respect to a horizontal plane, or at least about -45° with respect to a horizontal plane, up to an approximately vertical orientation, including increments of -1° from a -30° orientation to an approximately -90° orientation).
  • a downward, nonhorizontal orientation e.g., at least about -35° with respect to a horizontal plane, or at least about -45° with respect to a horizontal plane, up to an approximately vertical orientation, including increments of -1° from a -30° orientation to an approximately -90° orientation.
  • Such orientation is selected so that the injectable material readily passes out of the material delivery system (e.g., out of the delivery tubing 130a) and into the patient, leaving minimal, if any, residue behind in the delivery tubing 130a.
  • the mounting arm 170 may be formed as a separate element coupled (e.g., snapped or otherwise mated with) the outer wall 126 of the cover 120.
  • the mounting arm 170 may be in other forms or configurations than that illustrated in FIGS. 1 and 2, such as, without limitation, the form / configuration illustrated in the examples of embodiments a transport and delivery systems illustrated in FIGS. 6-20.
  • the mounting arm 170 is mounted to the cover 120 via a mounting cap 172 with mating features (e.g., clips 171 on the mounting arm 170 fitting with slots 173 in the mounting cap 172 or other suitable mating features as may be appreciated by those of ordinary skill in the art).
  • the cover 120 along with the tubing system 130 and the material access device 160 may be considered a part of a material delivery system 104.
  • the material delivery system 104 Before mating of the cover 120 with the base 110, the material delivery system 104 may be primed so that the material delivery system 104 is an airless primed system with the associated benefits known to those of ordinary skill in the art of not injecting air bubbles or pockets in the injectable material during delivery once assembled with the base 110.
  • Components of an example of an embodiment of a material delivery system 104 of a transport and delivery system 100 such as illustrated in FIG. 2 are illustrated in an exploded configuration in FIG. 4, with a priming cap 180 (shown partially in phantom).
  • the priming cap 180 is configured to cover the sharp ends 161a, 161b of the needles 160a, 160b of the material access device 160 (e.g., to protect against injury, accidents, inadvertent piercing, etc.) before accessing the contents of the vial 142 (see, e.g., FIG. 2) in which the injectable material is contained. Additionally, the priming cap 180 may include a septum 182 (which may be a part of the priming cap 180 or a separate element) through which the needles 160a, 160b extend. A sealed cavity or chamber may be defined within the priming cap 180, sealed by the septum 182.
  • the material delivery system 104 may be primed.
  • a flushing solution such as sterile saline, may be injected into the inlet tubing 130b of the tubing system 130 to flow into the inlet needle 160b, through the cavity created within the priming cap 180, out the outlet needle 160b, and out the delivery tubing 130a.
  • a tethered cap 132 such as illustrated in FIG. 1 and FIG. 4
  • finger clip 232 such as illustrated in FIG.
  • closure element e.g., a pinching clip or other closure element known to those of ordinary skill in the art mounted on the delivery tubing 130a or formed on the mounting arm 170, in conjunction with a one-way valve in the inlet tubing 130b may be actuated to maintain the material delivery system 104 as an airless primed system.
  • the material delivery system 104 may thereby be fluid locked on both ends so that air cannot enter the system.
  • the protective cap 150 of the material transport device 140 and the priming cap 180 over the needles 160a, 160b may be removed, and the cover 120 may be positioned over and pushed onto the base 110.
  • the material access device 160 aligns with the material transport device 140 so that the needles 160a, 160b pierce the septum 143 of the stopper 144 on the vial 142 to access the injectable material within the vial.
  • Tactile or audible feedback may confirm mating alignment.
  • FIGS. 6-20 various modifications to the cross-sectional shapes of the bases and covers of the transport and delivery system may be made, such as in the examples of embodiments illustrated in FIGS. 6-20.
  • the base 210 and the cover 220 each have substantially square cross-sectional shapes.
  • the base 310 and the cover 320 each have substantially rectangular cross- sectional shapes.
  • the internal configurations of the transport and delivery systems 200 and 300 of FIGS. 6 and 7, respectively may be substantially similar to the internal configuration of the transport and delivery system 100 of FIGS. 1, 2, and 4, with modifications to shape and size and dimension as may be readily appreciated by those of ordinary skill in the art and thus not illustrated in detail for the sake of brevity.
  • a cover with a cross-sectional shape may allow for mounting of a mounting arm 370 along a side thereof, such as illustrated in FIG. 7, rather than along the top side thereof (as in the examples of embodiments illustrated in FIGS. 1, 2, 4, and 6).
  • the mounting arm 370 may include a mounting leg 374 (mostly within and obstructed from view by the cover 320) which extends within a mounting slot 323 in the cover 320 (such as a side wall of the cover 320), similar to the mounting structure of the example of embodiment illustrated in FIGS. 1, 2, and 4.
  • a mounting leg 374 mostly within and obstructed from view by the cover 320 which extends within a mounting slot 323 in the cover 320 (such as a side wall of the cover 320), similar to the mounting structure of the example of embodiment illustrated in FIGS. 1, 2, and 4.
  • various components, features, etc. may be similar to those described above with respect to the transport and delivery system 100 illustrated in FIGS. 1, 3, and 4, and are not described further herein for the sake
  • the base portion of a transport and delivery system formed in accordance with various principles of the present disclosure may be in the form of a cartridge element smaller than the above-described base portions.
  • the cover portions of transport and delivery systems formed in accordance with various principles of the present disclosure may have smaller cross- sectional areas or dimensions than those described above, and more closely matching the cross- sectional area of the material transport device. For instance, in the examples of embodiments of transport and delivery systems 400 and 500 illustrated respectively in FIG. 8-12 and FIGS.
  • the cartridge-type base 410, 510 is insertable into a base-receiving cavity 421, 521 in the cover 420, 520 of the respective examples of embodiments of transport and delivery systems 400, 500 illustrated in FIG. 9 and FIG. 15, respectively.
  • the cartridge-type bases 410, 510 may be retained in the respective base-receiving cavity 421, 521 in any of a variety of manners known to those of ordinary skill in the art, such as a frictional engagement (e.g., with one or more friction inducing features on either element, shape / tolerancing, etc.), a snap lock engagement, a Luer-type lock, a locking groove and detent engagement (such as in FIG. 3), clip features (such as any known in the art), etc., the present disclosure not being limited in this regard.
  • a frictional engagement e.g., with one or more friction inducing features on either element, shape / tolerancing, etc.
  • a snap lock engagement e.g., with one or more friction inducing features on either element, shape / tolerancing, etc.
  • Luer-type lock e.g., Luer-type lock
  • a locking groove and detent engagement such as in FIG. 3
  • clip features such as any known in the art
  • the overall cross-sectional areas or dimensions of the cartridge-type bases 410, 510, and the portions of the respective covers 420, 520 in which the cartridge-type bases 410, 510 are retained in the examples of embodiments of transport and delivery systems 400, 500 illustrated in FIGS. 8 and 9, and FIGS. 14 and 15, respectively, may be reduced relative to the dimensions of the transport and delivery systems 100, 200, 300 described above with respect to FIGS. 1, 6, and 7, respectively. As such, the transport and delivery systems 400, 500 may be more readily manually grasped by and held in the hand of a medical professional.
  • the transport and delivery systems 400, 500 each have a tubing system 430, 530 generally similar to the tubing system 130 of the transport and delivery system 100 illustrated in FIG. 1 and FIG. 2. Additionally, in accordance with various principles of the present disclosure, the transport and delivery systems 400, 500 each have a material access device 460, 560 generally similar to the material access device 160 of the transport and delivery system 100 illustrated in FIG. 1, FIG. 2, and FIG. 4. Accordingly, for the sake of brevity, and without intent to limit, reference is made to the above descriptions of details of a tubing system and a material access device as applicable to the examples of embodiments of transport and delivery systems 400, 500 illustrated in FIGS. 8- 12 and FIGS. 13-15, respectively.
  • covers 420, 520 along with the tubing systems 430, 530 and the material access devices 460, 560 may be considered a part of a material delivery system 404, 504 of the respective transport and delivery systems 400, 500, such as illustrated in FIG. 9 and FIG. 15, respectively.
  • the mounting arm 470 of the illustrated transport and delivery system 400 may have a passage 471 defined therein through which a delivery tubing 430a of the tubing system 430 of the material delivery system 404 may be guided. More particularly, the mounting arm 470 of the example of an embodiment of a transport and delivery system 400 illustrated in FIGS. 8-12 generally guides the delivery tubing 430a downwardly to facilitate delivery of injectable material from the material transport device 440 by the material delivery system 404 and into a patient. As may be appreciated with reference to FIG. 9, FIG. 11, and FIG.
  • a port 473 may be defined in the mounting arm 470 configured to hold the delivery end 433 of the delivery tubing 430a. Additionally, the port 473 may be configured to be coupled with a microcatheter provided to deliver the injectable material to a patient, and to fluidly communicate the delivery tubing 430a with such microcatheter.
  • the delivery end 533 of the delivery tubing 530a may connect in a downward direction with the microcatheter seated within the holder 572, forming a fluid path from the delivery tubing 530a to the microcatheter to direct injectable material transported from the material transport device 540 by the material delivery system 504 into a patient.
  • the connection between the delivery tubing 530a and the microcatheter e.g., via a female Luer-type lock fitting associated therewith
  • an adapter 534 such as a male Luer-type lock fitting, that is operatively associated with the delivery end 533 (e.g., the terminal end) of the delivery tubing 530a.
  • the holder 572 may be configured to hold the microcatheter in place relative to the mounting arm 570.
  • the mounting arm 570 includes an insertion slot 575 for insertion of a microcatheter therethrough to be mounted / held therein. It will be appreciated that the location of the holder 572 along the mounting arm 570 and/or the specific configuration may be modified as may be appreciated by of ordinary skill in the art, the present disclosure not being limited by the specific configuration, location, etc., of these elements.
  • the respective material delivery systems 404, 504 may be primed so that the material delivery systems 404, 504 are airless primed system with the associated benefits known to those of ordinary skill in the art of not injecting air bubbles or pockets in the injectable material during delivery.
  • the needles 460a, 460b of the material access device 460 of the illustrated example of an embodiment of a transport and delivery system 400 extend into a priming cap 480.
  • the priming caps 480, 580 may be removed.
  • the priming caps 480, 580 may include one or more finger grips 484, 584 respectively extending downwardly therefrom, such as shown in FIGS. 10-12 and FIG. 13, to facilitate grasping thereof to remove the priming caps 480, 580.
  • the example of an embodiment of a transport and delivery system 600 illustrated in FIG. 16, FIG. 17, FIG. 18, and FIG. 19 includes a mounting arm 670 carrying the material access device 660.
  • the mounting arm 670 is movable to shift the material access device 660 between a position / configuration in which the material access device 660 is operatively engaged (e.g., in fluid communication) with the priming system 680, as illustrated in FIG. 16 and FIG. 17, and a position / configuration in which the material access device 660 is operatively engaged (e.g., in fluid communication) with the material transport device 640, as illustrated in FIG. 18 and FIG. 19.
  • elements shown as integrally formed may be constructed of multiple parts or elements shown as multiple parts may be integrally formed, the operation of elements may be reversed or otherwise varied, the size or dimensions of the elements may be varied.
  • operations or actions or procedures are described in a particular order, this should not be understood as requiring such particular order, or that all operations or actions or procedures are to be performed, to achieve desirable results.
  • other implementations are within the scope of the following claims. In some cases, the actions recited in the claims can be performed in a different order and still achieve desirable results.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Hematology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biomedical Technology (AREA)
  • Anesthesiology (AREA)
  • Vascular Medicine (AREA)
  • Physics & Mathematics (AREA)
  • General Engineering & Computer Science (AREA)
  • High Energy & Nuclear Physics (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L'invention concerne un système de transport et d'administration qui peut être utilisé pour des substances injectables tels que des produits injectables radioactifs. Le système comprend une base configurée pour contenir un dispositif de transport de substance contenant la substance injectable, et un couvercle comprenant un système d'administration de substance et un dispositif d'accès à une substance. Le couvercle est configuré pour être accouplé à la base afin d'obtenir l'alignement du dispositif d'accès à une substance avec le dispositif de transport de substance pour permettre au système d'administration de substance d'administrer les substances injectables de l'intérieur du dispositif de transport de substance à un patient. Le couvercle peut comprendre une poignée pouvant être saisie dans la main d'un adulte pour faciliter la préhension/manipulation du système. Un capuchon d'amorçage peut être prévu pour permettre l'amorçage du système d'administration de substance et au dispositif d'accès à la substance d'être sensiblement sans air.
EP22839570.3A 2022-11-22 2022-11-22 Dispositifs, systèmes et procédés d'administration de substances injectables Pending EP4395847A1 (fr)

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PCT/US2022/050684 WO2024112329A1 (fr) 2022-11-22 2022-11-22 Dispositifs, systèmes et procédés d'administration de substances injectables

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EP4395847A1 true EP4395847A1 (fr) 2024-07-10

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Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR1484669A (fr) * 1966-02-23 1967-06-16 Commissariat Energie Atomique Réceptacle pour le transport et le transfert de liquide radioactif
WO2010085870A1 (fr) * 2009-01-30 2010-08-05 Mds (Canada) Inc. Procédé pour accroître la résistance aux fuites dans un système fermé sous pression comportant un récipient fermé par un opercule
EP2938389B1 (fr) * 2012-12-27 2018-02-21 Medi-Physics, Inc. Récipient de transport
CA2991440C (fr) * 2015-07-17 2024-01-09 Np Medical Inc. Dispositif de raccordement et stabilisation d'un catheter et ses procedes d'utilisation
US11224555B2 (en) * 2018-04-23 2022-01-18 Hospira, Inc. Access and vapor containment system for a drug vial and method of making and using same
JP2024507869A (ja) * 2021-02-22 2024-02-21 バード・ペリフェラル・バスキュラー・インコーポレーテッド 微粒子材料送達のための管構成要素および形成の方法

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