Drug priming package

Abstract

An injection device preparation tray includes a collection reservoir configured to receive a distal end of a needle and a portion of the injection substance conveyed from the distal end of the needle and a fluid absorption material disposed within the collection reservoir and configured to retain the portion of the injection substance. In addition, the injection device preparation tray includes a reservoir viewing window extending along a top portion of the collection reservoir and configured to allow a user to observe when the injection substance is conveyed into the collection reservoir and a reservoir seal disposed along a needle channel, the reservoir seal configured to seal the collection reservoir so as to limit the injection substance from passing from the collection reservoir through the reservoir seal into the needle channel.

Description

DRUG PRIMING PACKAGECROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Application No. 63 / 738,472, filed on December 23, 2024, which is incorporated by reference herein in its entirety.BACKGROUND

[0002] Pharmaceutical products (including large and small molecule pharmaceuticals, hereinafter “drugs”) are administered to patients using a variety of different drug delivery devices for the treatment of a variety of different medical indications. Drug delivery devices for delivering liquid drugs include, for example, syringes, manual injectors, pen injectors, autoinjectors, on-body delivery devices, and off-body delivery devices. These delivery devices commonly include an actuator, a drug container, and a needle or cannula. Further, drug delivery devices commonly require priming to accurately and effectively deliver the drugs to patients.SUMMARY

[0003] In one aspect, an injection device preparation tray is described. The injection device preparation tray may include a collection reservoir configured to receive a distal end of a needle and a portion of the injection substance conveyed from the distal end of the needle and a fluid absorption material disposed within the collection reservoir and configured to retain the portion of the injection substance. In addition, the injection device preparation tray may include a reservoir viewing window extending along a top portion of the collection reservoir and configured to allow a user to observe when the injection substance is conveyed into theMEI 51557244v.1collection reservoir and a reservoir seal disposed along a needle channel, the reservoir seal configured to seal the collection reservoir so as to limit the injection substance from passing from the collection reservoir through the reservoir seal into the needle channel. The injection substance may be a suspension of nanoparticles or nanoparticle aggregates comprising hafnium oxide with a biocompatible phosphate coating at a concentration of 54 g / L and a pH of 6 to 8. In another aspect, a kit is described. The kit may include a medical injection device. The medical injection device may include: a handle to administer injection to a subject, having a proximal end configured for attachment to an injection substance supply and a distal end configured for attachment to a working channel, the handle including a plurality of nested tubular member; a needle coupled to the distal end of the handle, the needle having a proximal end, a distal end, and a lumen configured to convey injection substance from the proximal end to the distal end; and a sheath coupled to the distal end of the handle, the sheath having a proximal end and a distal end and configured to shroud the distal end of the needle, wherein the needle is situated within the sheath. The plurality of nested tubular members are user operable to move independently of each other. Further, the plurality of nested tubular members may be user operable to independently extend and retract the needle and the sheath. Additionally, the kit may include an injection device preparation tray. The injection device preparation tray may include a collection reservoir configured to receive the distal end of the needle and receive and retain a portion of the injection substance for preparation of the medical injection device. The injection substance may be a suspension of nanoparticles or nanoparticle aggregates comprising hafnium oxide with a biocompatible phosphate coating at a concentration of 54 g / L and a pH of 6 to 8.

[0005] In yet another aspect, a method for preparing a medical injection device is described. The method may include: attaching a handle of the medical injection device to an injection2MEI 51557244v.1substance supply; priming the needle with an injection substance from the injection substance supply through the handle; detecting when the injection substance is dispensed from the needle into a collection reservoir of an injection preparation tray using a reservoir viewing window of the collection reservoir; retaining the injection substance in the collection reservoir using a fluid absorption material disposed in the collection reservoir; withdrawing the needle from the collection reservoir; and sealing the collection reservoir using a reservoir seal configured to seal the collection reservoir when the needle is removed through the reservoir seal. In addition, according to some embodiments, the method may include: prior to attaching the handle of the medical injection device to the injection substance supply, opening a kit for the injection device, the kit including the medical injection device and the injection device preparation tray. The injection substance may be a suspension of nanoparticles or nanoparticle aggregates comprising hafnium oxide with a biocompatible phosphate coating at a concentration of 54 g / L and a pH of 6 to 8.BRIEF DESCRIPTION OF THE DRAWINGS

[0006] FIG. 1 depicts an exterior top view of an example medical injection device according to one or more embodiments described herein.

[0007] FIGS. 2A and 2B depict an exterior top view and an interior cross-section view, respectively, of an example medical injection device in a fully extended position according to one or more embodiments described herein.

[0008] FIGS. 2C and 2D depict an exterior top view and an interior cross-section view, respectively, of an example medical injection device in a fully compacted position according to one or more embodiments described herein.3MEI 51557244v.1

[0009] FIG. 3A and 3B depict a distal end of an example medical injection device with a needle in a retracted position and an extended position, respectively, according to one or more embodiments described herein.

[0010] FIG. 4 depicts an exterior perspective view of an example injection device preparation tray according to one or more embodiments described herein.

[0011] FIGS. 5 A and 5B depict an exterior top view and an interior cross-section view, respectively, of an example collection reservoir for an injection device preparation tray according to one or more embodiments described herein.

[0012] FIG. 6 depicts an exterior perspective view of an example injection device kit according to one or more embodiments described herein.

[0013] FIG. 7 depicts an example flowchart for a method for preparing a medical injection device using an example injection device kit according to one or more embodiments described herein.DETAILED DESCRIPTION

[0014] To treat health conditions for patients, drugs in fluid form are injected into the patient for treatment. Often, drug delivery devices including needles are used to inject the drugs into the patient. In most cases, it may be desirable to prime the drugs to a tip of the needle prior to inserting and injection into the patient. Priming of the drugs requires the drug to be filled to a tip of the needle to be used for delivery of the drug. Currently, clinicians have limited capabilities to determine when the tip of a needle is filled with drugs for injection. For example, priming of drugs requires clinicians to continually push drugs through a drug delivery device until a portion of the fluid is discharged from the tip of the needle. However, there are some limitations to this4MEI 51557244v.1approach. For example, such an approach may result in unnecessary waste of the drug due to discharging too much of the drug before the drug is no longer pushed to the tip of the needle. Additionally, in cases when the drug is a hazardous fluid, such an approach may expose users and the environment to the hazardous fluid when discharged, which can harm the user and others within the environment. Further, the hazardous fluid may not be properly disposed of after discharge, which may harm others who are exposed to the hazardous fluid after disposal. As such, existing solutions do not provide adequate collection and isolation of the hazardous fluid after discharge during priming.

[0015] As discovered by the inventors, and as will be described below in relation to FIGS. 4-7, a preparation packaging for a medical injection device can be used to detect when a tip of a needle is filled and collects any discharged fluid during priming of the fluid. By using a collection reservoir housed within the preparation packaging, the filling of the tip of the needle can be detected quickly. Upon detection of the tip of the needle being filled, a user may be able to determine when to stop pushing additional drug to the tip of the needle. Based on the observation of the collection reservoir, waste of potentially expensive drugs may be minimized by quick detection of filling of the tip of the needle. Additionally, the collection reservoir may be used to contain and isolate any discharged amount of fluid during priming of the fluid.Collection and isolation of the fluid by the collection reservoir may prevent exposing users of a medical injection device and the environment to the discharged fluid.

[0016] FIG. 1 depicts an exterior top view of an example medical injection device 100 according to one or more embodiments described herein. FIGS. 2A and 2B depict an exterior top view and an interior cross-section view, respectively, of the example medical injection device 100 in a fully extended position according to one or more embodiments described herein.5MEI 51557244v.1FIGS. 2C and 2D depict an exterior top view and an interior cross-section view, respectively, of the example medical injection device 100 in a fully compacted position according to one or more embodiments described herein. FIG. 3A and 3B depict a distal end of the example medical injection device 100 with a needle 50 in a retracted position and an extended position, respectively, according to one or more embodiments described herein.

[0017] In some embodiments, the medical injection device 100 may include: a handle (or nested handle) 110 having three nested tubular members, namely a first tubular member 10, a second tubular member 20, and a third tubular member 30; a sheath 40; and a needle 50. In some embodiments, the medical injection device 100 may include a plurality of nested tubular members, such as two, three, four or more nested tubular members. The medical injection device 100 may be configured, for example: to translate the needle 50 as the needle 50 travels through a working channel attached to medical injection device 100, where the needle is, for example, being guided to a tumor in a subject; to avoid having the needle 50 puncture the working channel or the subject while traveling through the working channel by having the tip of the needle 50 shrouded in the sheath 40; to extend and then lock the distal end of the sheath 40 in an axial position, while the tip at the distal end of the needle 50 is still shrouded in the sheath 40, to confirm the location of the tip of the needle prior to insertion of the tip of the needle 50 into the tumor; to extend the tip of the needle 50 out of the sheath 40 and insert the tip of the needle 50 into the tumor; to lock the tip of the the needle 50 in an unmoving position in the axial direction so as to confirm the location of the tip of the needle 50 after insertion of the tip of the needle 50 into the tumor and prior to injection of the medical substance; to lock the tip of the the needle 50 in an unmoving position in the axial direction during the injection of the medical6MEI 51557244v.1substance; and / or to safely withdraw the tip of the needle 50 from the tumor and out of the subject.

[0018] The handle 110 may be configure to administer injection to a subject. The handle 100 may have a proximal end 111 configured to attachment to an injection substance supply and a distal end 112 configured to attachment to a working channel. The medical injection device 100 may include a fastener 35 to fasten or attach the handle 110 to a working channel, such as, for example, a scope working channel, an extended working channel, or a robotic working channel. The fastener 35 may be configured to align and rigidly connect needle 50 to a working channel. In some embodiments, the fastener 35 may be a rotating male luer collar, may be snap fitted onto the support rod 60, and may allow a user to align the handle 10 with the working channel prior to fixing or securing the handle 10 to a working channel.

[0019] The handle 110 may include a plurality of nested tubular members, such as the first tubular member 10, the second tubular member 20, and the third tubular member 30. The third tubular member 30 may be nested in the second tubular member 20, and the second tubular member 20 may be nested in the first tubular member 10. The plurality of nested tubular members may be user operable to move independently of each other. The plurality of nested tubular members may be user operable to independently extend and retract the needle 50 and the sheath 40 from the working channel.

[0020] The needle 50 may be positioned within the sheath 40 and may have a proximal end 51, a distal end 52, a lumen 53 configured to convey injection substance from the proximal end 52 to the distal end 53, and a bevel tip 54 at the distal end 52 configured to eject injection substance from the needle 50. The sheath 40 may have a proximal end 41 and a distal end 42 and may be configured to shroud a distal end 52 of the needle 50. The proximal end 41 of the7MEI 51557244v.1sheath 40 may be flared and pushed over a barbed hub and may be secured in place with a snap fit collar. The needle 50 is at least partially disposed within the sheath 40. The proximal end 51 of the needle 50 may be positionally fixed within the first tubular member 10. As shown in FIGS. 3A and 3B, the sheath 40 may have an opening 43, and the distal end 52 of the needle 50 may be configured to selectively extend from and retract into the opening 43 of the sheath 40 by operation of the handle 110. Thus, the needle may have a length from its proximal end 51 inside the first tubular member 10 to its distal end 52 adjacent the distal end 42 of the sheath 40 that is at least as long as the sheath 40. The needle 50 may also be flexible along its length to flex within the sheath 40. As shown in FIG. 3A, in its retracted position, the distal end 52 of the needle 50 is retracted into or shrouded in the sheath 40. As shown in FIG. 3B, in its extended position, the distal end 52 of the needle 50 is extended from or pushed out of the sheath 40.

[0021] The first tubular member 10 may have a proximal end 11 and a distal end 12. The proximal end 11 may be configured to attach to the injection substance supply. The proximal end 11 may include a female luer 18 configured to connect to the injection substance supply. For example, if the injection substance is a fluid, the female luer 18 may be configured to connect to a fluid line. To assist a user in gripping the handle 110, the distal end 12 of the first tubular member 10 may have a cylindrical concave shape 1116 and a cylindrical convex shape 1118 that are coupled together. As shown in FIG. 2B, an inner portion of the first tubular member 10 may be fixedly attached to the proximal end 51 of the needle 50. The first tubular member 10 may be user operable to extend the needle 50 from the sheath 40 and to retract the needle 50 into the sheath 40. In other words, movement of the first tubular member 10 proximally or distally along a longitudinal direction 113 of the handle 110 relative to the second tubular member 20 and the8MEI 51557244v.1sheath 40 causes an equal movement of the needle 50 proximally or distally along the longitudinal direction 113 relative to the second tubular member 20 and the sheath 40.

[0022] As shown in FIG. 2B, the first tubular member 10 may include a channel 19 extending between the proximal end 11 and the distal end 12 of the first tubular member 10, and the needle 50 may be positionally fixed within the channel 19 of the first tubular member 10. Via the channel 19, the first tubular member 10 may be configured to convey injection substance from the proximal end 11 of the first tubular member 10 to the proximal end 51 of the needle 50.

[0023] The first tubular member 10 may be configured to slide or move along the longitudinal direction 113 relative to the second tubular member 20. The first tubular member 10 may be configured to slide or move along an exterior of the second tubular member 20. The first tubular member 10 may be configured to move back-and-forth between a first position (e.g., FIG. 2A and 2B) and a second position (e.g., FIG. 2C and 2D) with respect to the second tubular member 20. As shown in FIG. 3A, when the first tubular member 10 is in the first position (e.g., FIG. 2A and 2B), the bevel tip 54 at the distal end 52 of the needle 50 may be shrouded by the sheath 40, and as shown in FIG. 3B, when the first tubular member 10 is in the second position (e.g., FIG. 2C and 2D), the bevel tip 54 at the distal end 52 of the needle 50 may not be shrouded by the sheath 40. Moving the first tubular member 10 from the first position to the second position relative to the second tubular member 20 may extend the bevel tip 54 at the distal end 52 of the needle 50 from the distal end 42 of the sheath 40, and moving the first tubular member 10 from the second position to the first position relative to the second tubular member 20 may retract the bevel 54 at the distal end 52 of the needle 50 into the distal end 42 of the sheath 40.

[0024] To illustrate a location of the first tubular member 10 with respect to the second tubular member 20, the handle 110 may include indicia or markings 24 (e.g., numbers, letters,9MEI 51557244v.1symbols, lines, etc.). The first tubular member 10 may include a viewing window 13 configured to a user to view the indicia 24 on the second tubular member 20. The indicia 24 may include unique indicia to indicate a particular position of the first tubular member 10. For example, as shown in FIGS. 1 A, 2A, and 2B, the second tubular member 20 is in a fully retracted position, and the indicia 24 of a square is visible in the viewing window 13 to indicate the fully retracted position of the first tubular member 10.

[0025] The first tubular member 10 may be user operable to be locked and unlocked with respect to a second tubular member 20. The medical injection device 100 may further include a user operable lock (or needle lock) 15 to lock and unlock the first tubular member 10 with respect to the second tubular member 20. The lock 15 may prevent inadvertent extension of the needle 50 from the medical injection device 100. In some embodiments, the lock 15 may be a slide lock. The lock 15 may be any suitable lock for fixing a position of the first tubular member 10 relative to the second tubular member 20. One example of the lock 15 is discussed further below.

[0026] The medical injection device 100 may further include a stop (or first tubular member stop) 17 to prevent the first tubular member 10 from moving past a stopping position on the second tubular member 20. The stop 17 may be configured to limit the extension of the tip of the needle 50 from the distal end of the sheath 40 by limiting the movement of the first tubular member 10 relative to the second tubular member 20. The distance that the tip of the needle 50 may travel axially is limited by the stop 17 preventing the second tubular member 20 from retracting into the first tubular member 10. The stop 17 may be configured to limit the extension of the needle 50 from the sheath 40. The stop 15 may be at a fixed position with respect to the second tubular member 20 or may be user operable to move back-and-forth along the10MEI 51557244v.1longitudinal direction 113 such that the stop 15 can be selectively fixed to the second tubular member 20 at various positions along the longitudinal direction 113. The stop can be any suitable stop that limits retraction of the first tubular member 10 relative to the second tubular member 20. For instance, in some examples, the stop 17 may be a clip or ring that may slide along an exterior of the second tubular member 20. The stop 17 may permit the first tubular member 10 to move back-and-forth between a first position and a second position with respect to the second tubular member 20 but not to a third position with respect to the second tubular member 20, where the second position is between the first position and the third position, where the third position is along the longitudinal direction 113 and where the second position is user adjustable.

[0027] The second tubular member 20 may have a proximal end 21 and a distal end 22. The proximal end 21 is positioned within the first tubular member 10. As shown in FIG. 2B, an inner portion of the second tubular member 20 may be fixedly attached to the proximal end 41 of the sheath 40. The second tubular member 20 may user operable to extend the sheath 40 from the handle 110 and retract the sheath 40 into the handle 110. In other words, movement of the second tubular member 20 proximally or distally along the longitudinal direction 113 causes an equal movement of the sheath 40 proximally or distally along the longitudinal direction 113 and the working channel. Further, movement of the first tubular member 10 and the second tubular member 20 together relative to the third tubular member 30 causes an equal movement of both the needle 50 and sheath 40 together proximally or distally along the longitudinal direction 113 and the working channel.

[0028] As shown in FIG. 2B, the second tubular member 20 may include a channel 29 extending between the proximal end 21 and the distal end 22 of the second tubular member 20,11MEI 51557244v.1and the proximal end of the sheath 40 may be fixedly attached within the channel 29 of the second tubular member 20. Via the channel 29, the second tubular member 20 may be configured to convey the needle 50 from the distal end 22 of the second tubular member 20 to the distal end 42 of the sheath 40.

[0029] Independent of the second tubular member 20, the distal end 12 of the first tubular member 10 may be configured to slide or move in the longitudinal direction 113 along an exterior of the second tubular member 20. Independent of the first tubular member 10, the second tubular member 20 may be configured to slide or move in the longitudinal direction 113 along an exterior of the third tubular member 30. The second tubular member 20 may be configured to move back-and-forth between a first position (e.g., FIG. 2A and 2B) and a second position (e.g., FIG. 2C and 2D) respect to the third tubular member 30. When the second tubular member 20 is in the first position (e.g., FIG. 2A and 2B), the sheath 40 may be retracted within the working channel, and when the second tubular member 20 is in the second position (e.g., FIG. 2C and 2D), the sheath 40 may be extended from the working channel. Moving the second tubular member 20 from the first position to the second position may extend the sheath 40 from a distal end of the working channel, and moving the second tubular member 20 from the second position to the first position may retract the sheath 40 into the distal end of the working channel.

[0030] The second tubular member 20 may be user operable to be locked and unlocked with respect to the third tubular member 30. The medical injection device 100 may further include a user operable lock (or sheath lock) 25 to lock and unlock the second tubular member 20 with respect to the third tubular member 30. The lock 25 may prevent inadvertent extension of the sheath 40 from the medical injection device 100. The lock 25 can be any suitable lock for locking the second tubular member 20 with respect to the third tubular member 30. For instance,12MEI 51557244v.1in some examples, the lock 25 may be a thumb screw, which may be tightened to lock the second tubular member 20 with respect to the third tubular member 30 and loosened to unlock the second tubular member 20 with respect to the third tubular member 30. In other examples, the lock 25 can comprises a push pin or a have a slide member similar to lock 15.

[0031] To illustrate a location of the second tubular member 20 with respect to the third tubular member 30, the handle 110 may include indicia or markings 34 (e.g., numbers, letters, symbols, lines, etc.). The second tubular member 20 may include a viewing window 23 configured to a user to view the indicia 34 on the third tubular member 30. The indicia 34 may include unique indicia to indicate a particular position of the second tubular member 20. For example, as shown in FIGS. 1 A, 2A, and 2B, the second tubular member 20 is in a fully retracted position, and the indicia 34 of a square is visible in the viewing window 23 to indicate the fully retracted position of the second tubular member 20.

[0032] The medical injection device 100 may further include a stop 27 to prevent the second tubular member 20 from moving past a stopping position on the third tubular member 30. The stop 27 may be configured to limit the extension of the sheath 40 by limiting movement of the second tubular member 20 relative to the third tubular member 30. The distance that the sheath 40 may travel axially is limited by the stop 27 preventing the third tubular member 30 from retracting into the second tubular member 20. The stop 27 may be configured to limit extension of the sheath 40 relative to the third tubular member 30 and the working channel. The stop 27 may be at a fixed position with respect to the third tubular member 30 (as shown in FIG. 2B) or may user operable to move back-and-forth along the longitudinal direction 113. The stop 27 can be any suitable stop for limiting retraction of the second tubular member 20 relative to the third tubular member 30. For instance, in some examples, the stop 27 may be user operable to connect13MEI 51557244v.1the handle 110 to a working channel. As shown in FIG. 2B, the stop 27 may be a proximal end of the fastener 35, which may be configured to attach the medical injection device 100 to a working channel. In other examples, the stop 27 may be a clip or ring (such as the stop 17) that may slide along an exterior of the third tubular member 30 such that the stop 27 can be selectively fixed to the third tubular member 30 at various positions along the longitudinal direction 113.

[0033] The third tubular member 30 may have a proximal end 31 located within the second tubular member 20 and a distal end 32 configured to attachment to the working channel. The distal end 32 of the third tubular member 30 may be located at the distal end 112 of the handle 110. The fastener 35 may be configured to attach the distal end 32 of the third tubular member 30 to the working channel. The needle 50 and the sheath 40 may extend from distal end 32 of the third tubular member 30. The distal end 22 of the second tubular member 20 may be configured to move along an exterior of the third tubular member 30.

[0034] The medical injection device 100 may further include a support rod 60 extending from the distal end 112 of the handle 110. The support rod 60 may partially reside in the third tubular member 30 and may be rigidly fixed to the third tubular member 30. The support rod 60 may have a proximal end 61 inside the third tubular member 30 and a distal end 62 extending from the third tubular member 30 along the longitudinal direction 113. The distal end 62 of the support rod 60 may extend past the distal end 32 of the third tubular member 30 to assist a user with attaching the handle 110 to a working channel by providing an initial portion of the handle 110 to enter the enter working channel. The portion of the support rod 60 between the distal end 62 and the distal end 32 may also increase rigidity of the connection between (1) the handle 110 and (2) the working channel or other instrumentation (e.g., a scope) fixedly attached to the14MEI 51557244v.1working channel, so as to limit rotation of the handle 110 relative to the working channel or instrumentation.

[0035] The sheath 40 and the needle 50 may move independently of and relative to the support rod 60. The support rod 60 may provide rigidity to the sheath 40 and the needle 50 at the proximal end of the working channel attached to the distal end 112 of the handle 110.

[0036] FIG. 4 depicts an exterior perspective view of an example injection device preparation tray 400 according to one or more embodiments described herein. The preparation tray 400 may be used for priming a needle, such as needle 50, as will be discussed in further detail below. FIG. 4 depicts an injection device preparation tray 400 with a body 405. Body 405 may include a collection reservoir 410 formed into a portion of the body 405. The position of the collection reservoir 410 on the body 405 is exemplary and may be formed on any desired portion of the body 405. Additionally, the collection reservoir 410 may be any cross-sectional shape, such as rectangular, as shown in FIG. 4, circular, triangular, and the like. Further, the collection reservoir 410 may have a depth to allow the collection reservoir to receive a distal end of a needle, such as needle 50, and receive a portion of the injection substance conveyed from the distal end of the needle. The needle, when received in the reservoir 410, may be shrouded in sheath 40. In cases when the injection substance is a hazardous medicant, the collection reservoir 410 may be used to contain and isolate the hazardous medicant and prevent exposure of the hazardous medicant to medical professionals and the surrounding environment.

[0037] The collection reservoir 410 may have a reservoir viewing window 411 extending along a top portion of the collection reservoir 410. The reservoir viewing window 411 may be coupled to the body 405 to form a leak-proof seal around a perimeter of a top portion of the collection reservoir 410. The reservoir viewing window 411 may be used to isolate and prevent15MEI 51557244v.1any leakage of fluid discharged into the collection reservoir 410 from the top portion of the collection reservoir. Additionally, reservoir viewing window 411 may be made from an optically clear material to allow users to see into the collection reservoir 410 and observe when fluid (e.g. liquid medicant or injection substance) is conveyed into the collection reservoir 410 during priming of a needle.

[0038] In some embodiments, the fluid, liquid medicant, or injection substance is a nanoparticle or nanoparticle aggregate suspension. The term “nanoparticle” or “nanoparticle aggregate” refers to synthetic particles of small size. Their shape can be, for example, round, flat, elongated, spherical, oval, and the like. The size of the nanoparticles or nanoparticle aggregates can be between about 3 nm and 400 nm, between about 20 nm and 300 nm, or between about 40 nm and 100 nm. In some embodiments, the nanoparticles or nanoparticle aggregates can comprise an inorganic material comprising oxygen, such as a crystallized material. An exemplary material is a metal oxide, which is a chemical compound containing at least one oxygen atom and at least a second chemical element comprising a metal. In some embodiments, the metal oxide is a lanthanide element selected from the group consisting of CeCh, Nd2Ch, SrmCh, EU2O3, Gd2Ch, Tb2Ch, Dy2Ch, HO2O3, EnCh, TrmCh, Yb2O3, LU2O3, and combinations thereof. In some embodiments, the metal oxide is a metallic element of period 6 of the periodic classification of elements selected from the group consisting of HfCh, TaCh, Ta2Os, WO2, WO3, ReCh, OsO2, IrCh, PtO, PtCh, HgO, Hg2O, TI2O3, PbO, Pb2O3, PbsCU, PbCh, PoO2, Bi2O3, and combinations thereof. In some embodiments, the metal oxide is a metallic element of period 5 of the periodic classification of elements selected from the group consisting of NbO, RuCh, RI12O3, RhCh, PdO, Ag2O, AgO, CdO, ImCh, and combinations thereof. In some embodiments, the nanoparticles or nanoparticle aggregates comprise a biocompatible coating. The biocompatible16MEI 51557244v.1coating can include phosphates (for example an orthophosphate, an oligophosphate, a polyphosphate, a metaphosphate, a pyrophosphate, etc.), carboxylates (for example citrate, dicarboxylic acid, succinic acid), and sulphates. Contemplated phosphates include sodium trimetaphosphate and sodium hexametaphosphate. In some embodiments, the nanoparticles or nanoparticle aggregates have a density between about 7 g / cm3and 15 g / cm3, or between about 8 g / cm3and 12 g / cm3. In some embodiments, the nanoparticles or nanoparticle aggregates are suspended in a pharmaceutically acceptable excipient at a concentration between about 50 g / L and 64 g / L, or about 54 g / L. Contemplated excipients include but are not limited to water, glucose, saline, and the like. In some embodiments, the nanoparticle or nanoparticle aggregate suspension has a pH between about 6 and 8, or between about 6.5 and 7.5. In some embodiments, the nanoparticle or nanoparticle aggregate suspension comprises hafnium oxide with a biocompatible phosphate coating at a concentration of 54 g / L and a pH of 6 to 8.

[0039] Further, collection reservoir 410 may include a fluid absorption material 413 disposed within a bottom portion of the collection reservoir 410. The fluid absorption material 413 may be configured to retain the portion of the injection substance received by the collection reservoir 410. The fluid absorption material 413 may be any material with absorptive properties. In an embodiment, the fluid absorption material 413 may be anhydrous copper sulfate. Additionally, the fluid absorption material 413 may be configured to change color when an injection substance, such as injection substance conveyed by a needle during priming, contacts the fluid absorption material 413. For example, the fluid absorption material 413 may be configured to be start as a white color when dry and change to a blue color when an injection substance discharged from a distal end of a needle during priming contacts the fluid absorption material 413.17MEI 51557244v.1

[0040] Additionally, the collection reservoir 410 may include a reservoir seal 415 disposed along a needle channel 420 configured to limit an injection substance from passing from the collection reservoir 410 through the reservoir seal 415 into the needle channel 420 when a needle is not disposed through the reservoir seal 415. The reservoir seal 415 may be a body shaped to fill a space between the needle channel 420 and the reservoir viewing window 411 to prevent injection substance from passing between the reservoir seal 415 and the needle channel 420 and the reservoir seal 415 and the reservoir viewing window 411. In an embodiment, the reservoir seal 415 may be made of an elastomeric material. The elastomeric material may allow the reservoir seal 415 to secure around the needle and wipe the injection substance from the needle while the needle is being removed from the collection reservoir 410. Further, the elastomeric material may allow the reservoir seal 415 to temporarily deform around the needle to allow the needle to pass through the reservoir seal 415 during insertion of the needle into the collection reservoir 410. In an embodiment, the reservoir seal 415 may further comprise a fluid detection material configured to detect presence of the injection substance within the reservoir seal 415. In an embodiment, the fluid detection material of the reservoir seal 415 may configured to change color when the injection substance is present within the reservoir seal.

[0041] Still referring to FIG. 4, body 405 may include sheath storage cavity 430 formed into a portion of the body 405. The position of the sheath storage cavity 430 on the body 405 is exemplary and may be formed on any desired portion of the body 405. Additionally, the sheath storage cavity 430 may have any suitable cross-sectional shape, such as rectangular, circular (as shown in FIG. 4), triangular, and the like to store a sheath and / or needle in an organized manner. More specifically, as shown in FIG. 4, the sheath storage cavity 430 may be an annular cylinder shape with an annular cross section to allow the sheath and / or needle to wrap around a center of18MEI 51557244v.1the annular cylinder shape. Further, injection device preparation tray 400 may include a needle channel 420 formed in the body 405. The needle channel 420 may connect the sheath storage cavity 430 and the collection reservoir 410 and direct the distal portion of the sheath and needle into the collection reservoir 410. The needle channel 420 may be angled from a top portion of body 405 towards a bottom portion of collection reservoir 410 as the needle channel 420 extends from the sheath storage cavity 430 towards the collection reservoir 410 to promote flow of the injection substance towards the tip of the needle during priming, as shown in more detail in FIG.5B.

[0042] Additionally, injection device preparation tray 400 may include at least one support structure 440 formed into body 405. Each support structure 440 may have a depth that is substantially similar to the depth of the collection reservoir 410 to allow injection device preparation tray 400 to sit level when placed on a flat surface.

[0043] FIGS. 5 A and 5B depict an exterior top view and an interior cross-section view, respectively, of an alternative example collection reservoir 510 for an injection device preparation tray according to one or more embodiments described herein.

[0044] The collection reservoir 510 may include features from collection reservoir 410. For example, the collection reservoir 510 may include a reservoir viewing window 411 and a fluid absorption material 413, as described above.

[0045] As shown in FIG. 5 A, additionally, the collection reservoir 510 may include a reservoir seal 515. The reservoir seal 515 may include features from reservoir seal 415.Additionally, the reservoir seal 515 may further comprise a plurality of seal blades 517. The plurality of seal blades 517 may be made of an elastomeric material and may be disposed at an angle such that the plurality of seal blades 517 may be configured to slide along an axial length19MEI 51557244v.1of a needle and wipe the injection substance from the needle while the needle is being removed from the collection reservoir 510. The plurality of seal blades 517 may be disposed on a side of the reservoir seal 515 that is adjacent to a fluid absorption material 413. The plurality of seal blades 517 may be configured to provide additional wiping of the injection substance from the needle during removal of the needle from the collection reservoir 510 and further limit an injection substance from passing from the collection reservoir 510 through the reservoir seal 515 into a needle channel, such as needle channel 420, when a needle is not disposed through the reservoir seal 515.

[0046] As shown in FIG. 5B, distal end 52 of the needle 50 may be suspended above fluid absorption material 413 to promote flow of the injection substance towards the tip of the needle during priming. However, suspension of the needle 50 above fluid absorption material 413 is exemplary and the needle 50 may be positioned within collection reservoir 410, 510 to allow for the fluid absorption material 413 to collect and retain the injection substance received by the collection reservoir 410, 510 during priming of the needle 50 and allow for a user to observe when the injection substance is conveyed into the collection reservoir 410 through reservoir viewing window 411 during priming of a needle.

[0047] FIG. 6 depicts an exterior perspective view of an example injection device kit 600 according to one or more embodiments described herein. The injection device kit 600 includes an injection device 610 to administer injection to a subject. The injection device 610 may include features from injection device 100. For example, the injection device 610 may have a handle 611 to administer with a proximal end configured for attachment to an injection substance supply and a distal end configured for attachment to a working channel and comprise a plurality of nested tubular members. In an embodiment, the plurality of nested tubular members may be20MEI 51557244v.1user operable to move independently of each other. In an embodiment, the plurality of nested tubular members may be user operable to independently extend and retract the needle and the sheath. The injection device kit 600 may include a needle coupled to the distal end of the injection device 610. The needle may include features from needle 50. For example, the needle may include a proximal end, a distal end, and a lumen configured to convey injection substance from the proximal end to the distal end. The injection device kit 600 may include the needle shrouded within a sheath 620 coupled to the distal end of the injection device 610. The sheath 620 may include features from sheath 40. The injection device kit 600 may be used to conveniently package injection device 610, sheath 620, and the needle for distribution and keep the injection device 610, sheath 620, and the needle in a clean environment prior to use. The injection device kit 600 may include a collection reservoir 630 configured to receive the distal end of the needle and receive and retain a portion of the injection substance for preparation of the injection device 610. The collection reservoir 630 may include features from any one of collection reservoirs 410, 510. In an embodiment, the collection reservoir 630 may be disposed on a preparation tray 640. The preparation tray 640 may include features from needle preparation tray 400.

[0048] Additionally, the preparation tray 640 may include a cavity 645. Cavity 645 may be configured to receive and hold an injection device, for example injection device 610. Cavity 645 may have a shape substantially similar to a shape of an injection device to be received by cavity 645 to allow preparation tray 640 to accommodate injection device 610. For example, as shown in FIG. 6, cavity 645 has a shape that is substantially similar to injection device 610.

[0049] As shown in FIG. 6, the kit 600 may include a kit cover 650. The kit cover 650 may be used to seal the injection device kit 600 at a top portion of the preparation tray 640 to21MEI 51557244v.1maintain the injection device 610, the sheath 620, and the needle in a clean environment prior to use. The kit cover 650 may be configured such that removal of the kit cover 650 may allow access to a proximal end of a needle, such as needle 50, and / or injection device 610.Additionally, the kit cover 650 may be separate from collection reservoir 630 such that removal of the kit cover 650 may allow collection reservoir 630 to remain sealed. Once the kit cover 650 is removed, a user may be able to connect the injection device 610 to an injection substance supply and conveniently prime the injection device 610 with an injection substance from the injection substance supply until the injection substance is dispensed into the collection reservoir 630.

[0050] FIG. 7 depicts an example flowchart for a method for preparing a medical injection device according to one or more embodiments described herein. While an order of operations is indicated in FIG. 7 for illustrative purposes, the timing and ordering of such operations may vary where appropriate without negating the purpose and advantages of the examples set forth in detail herein.

[0051] In step 702, the handle 110, 610 of the medical injection device may be attached to an injection substance supply.

[0052] In step 704, a needle may be primed with an injection substance from the injection substance supply through the handle 110, 610.

[0053] In step 706, when the injection substance is dispensed from the needle into a collection reservoir 410, 510 of an injection device preparation tray, the injection substance may be detected using a reservoir viewing window 411. The collection reservoir 410, 510 may be configured to receive a distal end of the needle and receive and retain a portion of the injection substance from the distal end of the needle during preparation of the medical injection device. In22MEI 51557244v.1some embodiments, detecting when the injection substance is dispensed into the collection reservoir 410, 510 may comprise detecting a change in color of a fluid absorption material 413 disposed in the collection reservoir.

[0054] In step 708, the injection substance may be retained in the collection reservoir using a fluid absorption material 413 disposed in the reservoir.

[0055] In step 710, the needle may be withdrawn from the collection reservoir 410, 510. In some embodiments, withdrawing the needle from the collection reservoir may comprise using the reservoir seal to wipe the injection substance from the needle while the needle is being withdrawn from the reservoir. Additionally, or alternatively, in some embodiments, wiping the injection substance from the needle while the needle is being withdrawn from the collection reservoir using the reservoir seal may comprise using a plurality of seal blades to wipe the injection substance from the needle while the needle is being withdrawn from the reservoir.

[0056] In step 712, the collection reservoir may be sealed using a reservoir seal configured to seal the collection reservoir when the needle is removed through the reservoir seal.

[0057] Further, in some embodiments, the method 700 may include, prior to attaching the medical injection device 100, 610 to the injection substance supply, opening an injection device kit 600. The kit 600 may include the medical injection device 100, 610 and the injection device preparation tray 400, 640. The medical injection device 100, 610 may include: a handle 110, 611 to administer injection to a subject, having a proximal end configured for attachment to an injection substance supply and a distal end configured for attachment to a working channel, the handle 110, 611 comprising a plurality of nested tubular members; the needle 50 coupled to the distal end of the handle 110, 611, the needle 50 having a proximal end, a distal end, and a lumen configured to convey injection substance from the proximal end to the distal end; and a sheath 4023MEI 51557244v.1coupled to the distal end of the handle, the sheath 40 having a proximal end and a distal end and configured to shroud the distal end of the needle 50, wherein the needle 50 is situated within the sheath 40. The plurality of nested tubular members may be user operable to move independently of each other and to independently extend and retract the needle 50 and the sheath 40.

[0058] Additionally, method 700 may include detecting presence of the injection substance within the reservoir seal by a fluid detection material disposed within the reservoir seal. In some embodiments, detecting presence of the injection substance within the reservoir seal may comprise observing a change in color of the fluid detection material.

[0059] Embodiments illustrated under any heading or in any portion of the disclosure may be combined with embodiments illustrated under the same or any other heading or other portion of the disclosure unless otherwise indicated herein or otherwise clearly contradicted by context. For example, and without limitation, embodiments described in dependent claim format for a given embodiment (e.g., the given embodiment described in independent claim format) may be combined with other embodiments (described in independent claim format or dependent claim format).

[0060] Numerous modifications, alterations, and changes to the described embodiments are possible without departing from the scope of the present invention defined in the claims. It is intended that the present invention need not be limited to the described embodiments, but that it has the full scope defined by the language of the following claims, and equivalents thereof.24MEI 51557244v.1

Claims

CLAIMSWhat is claimed is:

1. An injection device preparation tray, comprising:a collection reservoir configured to receive a distal end of a needle and a portion of an injection substance conveyed from the distal end of the needle;a fluid absorption material disposed within the collection reservoir and configured to retain the portion of the injection substance;a reservoir viewing window extending along a top portion of the collection reservoir and configured to allow a user to observe when the injection substance is conveyed into the collection reservoir; anda reservoir seal disposed along a needle channel, the reservoir seal configured to seal the collection reservoir so as to limit the injection substance from passing from the collection reservoir through the reservoir seal into the needle channel.

2. The injection device preparation tray of claim 1, wherein the fluid absorption material is configured to change color when the injection substance contacts the fluid absorption material.

3. The injection device preparation tray of claim 2, wherein the reservoir seal comprises elastomeric material and the reservoir seal is configured to secure around the needle and wipe the injection substance from the needle while being extracted from the collection reservoir.25MEI 51557244v.

14. The injection device preparation tray of claim 3, wherein the reservoir seal further comprises a plurality of seal blades configured to slide along the needle and wipe the injection substance from the needle while being extracted from the collection reservoir.

5. The injection device preparation tray of claim 4, wherein the reservoir seal further comprises a fluid detection material configured to detect presence of the injection substance within the reservoir seal.

6. The injection device preparation tray of claim 5, wherein the fluid detection material is configured to change color when the injection substance is present within the reservoir seal.

7. The injection device preparation tray of claim 1, wherein the injection substance is a suspension of nanoparticles or nanoparticle aggregates comprising hafnium oxide with a biocompatible phosphate coating at a concentration of 54 g / L and a pH of 6 to 8.

8. A kit, comprising:a medical injection device, comprising:a handle to administer injection to a subject, having a proximal end configured for attachment to an injection substance supply and a distal end configured for attachment to a working channel, the handle comprising a plurality of nested tubular members;a needle coupled to the distal end of the handle, the needle having a proximal end, a distal end, and a lumen configured to convey injection substance from the proximal end to the distal end; anda sheath coupled to the distal end of the handle, the sheath having a proximal end26MEI 51557244v.1and a distal end and configured to shroud the distal end of the needle, wherein the needle is situated within the sheath;wherein the plurality of nested tubular members are user operable to move independently of each other,wherein the plurality of nested tubular members are user operable to independently extend and retract the needle and the sheath; andan injection device preparation tray, comprising:a collection reservoir configured to receive the distal end of the needle and receive and retain a portion of the injection substance for preparation of the medical injection device.

9. The kit of claim 8, wherein the collection reservoir comprises a fluid absorption material disposed within the collection reservoir and configured to retain the portion of the injection substance.

10. The kit of claim 9, wherein the fluid absorption material is configured to change color when the injection substance contacts the fluid absorption material.

11. The kit of claim 8, wherein the collection reservoir comprises a reservoir viewing window extending along a top portion of the reservoir and configured to allow a user to observe when the injection substance is conveyed into the collection reservoir.

12. The kit of claim 8, wherein the reservoir comprises a reservoir seal disposed along a needle pathway configured to seal the reservoir when the needle is retracted through the reservoir seal.27MEI 51557244v.

113. The kit of claim 12, wherein the reservoir seal comprises elastomeric material and the reservoir seal is configured to secure around the needle and wipe the injection substance from the needle when extracted from the reservoir.

14. The kit of claim 13, wherein the reservoir seal further comprises a plurality of seal blades configured to slide along the needle and wipe the injection substance from the needle while being extracted from the collection reservoir.

15. The kit of claim 14, wherein the reservoir seal further comprises a fluid detection material configured to detect presence of the injection substance within the reservoir seal.

16. The kit of claim 8, wherein the injection substance is a suspension of nanoparticles or nanoparticle aggregates comprising hafnium oxide with a biocompatible phosphate coating at a concentration of 54 g / L and a pH of 6 to 8.

17. A method for preparing a medical injection device, comprising:attaching a handle of the medical injection device to an injection substance supply; priming the needle with an injection substance from the injection substance supply through the handle;detecting when the injection substance is dispensed from the needle into a collection reservoir of an injection device preparation tray using a reservoir viewing window of the collection reservoir;retaining the injection substance in the collection reservoir using a fluid absorption material disposed in the collection reservoir;withdrawing the needle from the collection reservoir; and28MEI 51557244v.1sealing the collection reservoir using a reservoir seal configured to seal the collection reservoir when the needle is removed through the reservoir seal.

18. The method of claim 17, wherein detecting when the injection substance is dispensed into the reservoir comprises detecting a change in color of the fluid absorption material.

19. The method of claim 17, wherein withdrawing the needle from the reservoir comprises wiping the injection substance from the needle while being extracted from the reservoir using the reservoir seal.

20. The method of claim 19, wherein wiping the injection substance from the needle while being extracted from the reservoir using the reservoir seal comprises wiping the injection substance from the needle while being extracted from the reservoir using a plurality of seal blades.

21. The method of claim 20, further comprising detecting presence of the injection substance within the reservoir seal by a fluid detection material disposed within the reservoir seal.

22. The method of claim 21, wherein detecting presence of the injection substance within the reservoir seal comprises observing a change in color of the fluid detection material.

23. The method of claim 17, wherein the injection substance is a suspension of nanoparticles or nanoparticle aggregates comprising hafnium oxide with a biocompatible phosphate coating at a concentration of 54 g / L and a pH of 6 to 8.29MEI 51557244v.1

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