Nested handle medical injection system

Abstract

A medical injection device including: a handle to administer injection to a subject, the handle having a proximal end and a distal end, the proximal end configured to attach to an injection substance supply, and the distal end configured to attachment to a working channel, the handle comprising a plurality of nested tubular members; a 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 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, 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 from the working channel.

Description

NESTED HANDLE MEDICAL INJECTION SYSTEMCROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U. S. Provisional Application No. 63 / 738,444, filed December 23, 2024, to U. S. Provisional Application No. 63 / 738,455, filed December 23, 2024, and to U. S. Provisional Application No. 63 / 738,462, filed December 23, 2024, the contents of each of which are incorporated by reference herein in their 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. The drug container contains the liquid drug and the actuator drives the liquid drug from the drug container, and through the needle or cannula to the patient.SUMMARY

[0003] In some embodiments, a medical injection device may include: a handle to administer injection to a subject, the handle having a proximal end and a distal end, the proximal end configured to attach to an injection substance supply, and the distal end configured to attachment to a working channel, the handle comprising a plurality of nested tubular members; a needleMEI 48657880v.1having 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 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, 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 from the working channel. Additionally, 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.

[0004] In addition, the handle may further include a lock configured to prevent the needle from moving. The lock may be configured to communicate at least two operating conditions of the lock. The lock may be configured to tactilely communicate operating conditions of the lock to a user. The lock may be configured to prevent the needle from moving and to communicate operating conditions of the lock to a computer apparatus. The handle may include a fastener at the distal end of the handle configured to secure the handle to the working channel and to permit the handle to rotate until the handle is secured to the working channel.

[0005] In some embodiments, a medical injection device may include: a needle having a proximal end, a distal end, and a lumen configured to convey injection substance from the proximal end to the distal end; a 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; a first tubular member having a proximal end configured to attach to an injection substance supply and a distal end, wherein an inner portion of the first tubular member is attached to the proximal end of the needle; a second tubular member having a proximal end and a distal end, the proximal end located within the first tubular member, wherein an inner portion of the second tubular member 2MEI 48657880v.1is atached to the proximal end of the sheath, wherein the distal end of the first tubular member is configured to move along an exterior of the second tubular member; and a third tubular member having a proximal end and a distal end, the proximal end located within the second tubular member, and the distal end configured to attach to a working channel, wherein the needle and the sheath extend from distal end of the third tubular member, wherein the distal end of the second tubular member is configured to move along an exterior of the third tubular member.

[0006] In addition, the medical injection device may further include a first lock configured to prevent the needle from moving. The medical injection device may include a second lock to lock the second tubular member with respect to a third tubular member, wherein the first lock and the second lock have different modes of operation. The first lock may be configured to communicate to a user a locked condition and an unlocked condition of the first lock. The first lock may be configured to tactilely communicate to a user a locked condition and an unlocked condition of the first lock. The first lock may be configured to communicate to a computer apparatus a locked condition and an unlocked condition of the first lock. The medical injection device may further include a fastener at the distal end of the third tubular member configured to secure the medical injection device to the working channel and to permit the third tubular member to rotate until the medical injection device is secured to the working channel.

[0007] In some embodiments, a method for injecting a substance into a subject may include: inserting a working channel into a subject; inserting a needle shrouded by a sheath into the working channel; attaching a handle to the working channel, the handle connected to the needle and the sheath, the handle comprising a plurality of nested tubular members, the plurality of nested tubular members comprising a first tubular member and a second tubular member; extending the sheath from a distal end of the working channel by operating the second tubular 3MEI 48657880v.1member of the plurality of nested tubular members; locking the sheath in position; extending the needle from a distal end of the sheath by operating the first tubular member of the plurality of nested tubular members; locking the needle in position; and injecting the substance into the subject from the needle. Additionally, 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.

[0008] In addition, the method may further include operating a lock to lock the needle in position. The lock may include a first user communicative indicator when the needle is locked and a second user communicative indicator different from the first user communicative indicator when the needle is unlocked. The lock may include a first tactile indicator when the needle is unlocked and a second tactile indicator different from the first tactile indicator when the needle is locked. The lock may provide different signals to a computer apparatus in communication with the handle when the lock is in a locked position and in an unlocked position. After the attaching step and before the extending step, the method may include: rotating the handle with respect to the working channel to a user desired position; and securing the handle to the working channel with a fastener.

[0009] In an embodiment, a medical injection device is described. The medical injection device includes a handle to administer injection to a subject. The handle having a proximal end and a distal end. The proximal end is configured to attach to an injection substance supply and the distal end is configured to attach to a working channel. The handle comprises a plurality of nested tubular members. The medical injection device also includes a needle having a proximal end, a distal end, and a lumen configured to convey injection substance from the proximal end to the distal end of the needle. Further, the medical injection device includes a sheath having a 4MEI 48657880v.1proximal end and a distal end and the shroud is configured to shroud the distal end of the needle. The needle is situated within the sheath. Additionally, the medical injection device includes a lock configured to selectively (1) prevent the sheath from extending and retracting from the medical injection device, and (2) permit the sheath to extend and retract from the medical injection device. The lock is also configured to communicate at least two operating conditions of the lock. The plurality of nested tubular members are user operable to move independently of each other to independently extend and retract the needle and the sheath from the working channel. Additionally, 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.

[0010] In another embodiment, a method for injecting a substance into a subject is described. The method includes inserting a working channel into a subject, inserting a needle shrouded by a sheath into the working channel, and unlocking the sheath with first lock. Additionally, the method includes attaching a handle to the working channel, the handle connected to the needle and the sheath, the handle comprising a plurality of nested tubular members, the plurality of nested tubular members comprising a first tubular member and a second tubular member, extending the sheath from a distal end of the working channel by operating the second tubular member of the plurality of nested tubular members and locking the sheath in position with the first lock. Further, the method includes unlocking the first tubular member using a second lock, extending the needle from a distal end of the sheath by operating the first tubular member of the plurality of nested tubular members and locking the needle in position. Additionally, the injection substance is a suspension of nanoparticles or nanoparticle aggregates comprising5MEI 48657880v.1hafnium oxide with a biocompatible phosphate coating at a concentration of 54 g / L and a pH of 6 to 8.

[0011] In an embodiment, a medical injection device is disclosed. The medical injection device includes a handle to administer injection to a subject. The handle having a proximal end and a distal end. The proximal end is configured to attach to an injection substance supply and the distal end is configured to attach to a working channel. The handle includes a first tubular member and a second tubular member. In addition, the medical injection device includes a needle having a proximal end, a distal end, and a lumen configured to convey injection substance from the proximal end to the distal end. The medical injection device also includes a 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. Further, the medical injection device includes a lock comprising (i) a needle lock control configured to secure and unsecure the second tubular member to the first tubular member and (ii) at least one first body disposed on an interior of the first tubular member, wherein the lock is configured to selectively (1) prevent the needle from extending and retracting from the sheath and (2) permit the needle to extend and retract from the sheath. The first tubular member and second tubular member are user operable to move independently of each other and to independently extend and retract the needle and the sheath from the working channel. Additionally, 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.

[0012] In another embodiment, a medical injection device is described. The medical injection device includes a handle to administer injection substance to a subject, having a proximal end and a distal end, the proximal end configured to attach to an injection substance 6MEI 48657880v.1supply and the distal end configured to attach to a working channel, the handle comprising a first tubular member and a second tubular member. The second tubular member includes at least one protrusion and a biasing member configured to bias the at least one protrusion towards the first tubular member. The medical injection device also includes a 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 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. Further, the medical injection device includes a lock configured to selectively (1) prevent the needle from extending and retracting from the sheath and (2) permit the needle to extend and retract from the sheath. The first tubular member and second tubular member are user operable to move independently of each other and to independently extend and retract the needle and the sheath from the working channel. Additionally, 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.

[0013] In another embodiment, a method for injecting a substance into a subject is described. The method includes inserting a working channel into a subject, inserting a needle shrouded by a sheath into the working channel and attaching a handle to the working channel, the handle connected to the needle and the sheath, the handle comprising a plurality of nested tubular members, the plurality of nested tubular members comprising a first tubular member and a second tubular member. Additionally, the method includes extending the sheath from a distal end of the working channel by operating the second tubular member of the plurality of nested tubular members and locking the sheath in position. Further, the method includes unlocking the needle by depressing a needle lock control of a lock, wherein the lock is biased into a locked 7MEI 48657880v.1state and extending the needle from a distal end of the sheath by moving the needle lock control. The methods also includes locking the needle in position by releasing the needle lock control and injecting the substance into the subject from the needle. Additionally, the substance includes 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

[0014] FIG. 1 depicts an exterior top view of an example medical injection device according to one or more embodiments described herein.

[0015] 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.

[0016] 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.

[0017] FIGS. 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.

[0018] FIG. 4A depicts a partial exterior top view of portion 4A in FIG. 2A and FIG. 4B depicts an interior cross-section view of portion 4B in FIG. 2B of the example medical injection device with a lock in a locked position according to one or more embodiments described herein

[0019] FIG. 4C depicts a partial exterior top view of portion 4C in FIG. 2A and FIG. 4D depicts an interior cross-section view of portion 4D in FIG. 2B of the example medical injection 8MEI 48657880v.1device with a lock in an unlocked position according to one or more embodiments described herein.

[0020] FIG. 5A depicts a partial exterior top view of a lock in a locked position and FIG. 5B depicts a partial exterior top view of the lock in an unlocked position according to one or more embodiments described herein.

[0021] FIG. 6A depicts a partial exterior perspective view of the example medical injection device with a lock in a locked position and FIG. 6B depicts a partial exterior perspective view of the example medical injection device with a lock in an unlocked position according to one or more embodiments described herein.

[0022] FIG. 6C depicts an exterior perspective view of the lock of FIGS. 6A and 6B in an unlocked position according to one or more embodiments described herein.

[0023] FIG. 6D depicts a partial interior cross-section perspective view of the lock of FIG.6C in a locked position according to one or more embodiments described herein.

[0024] FIG. 6E depicts a partial interior cross-section perspective view of the lock of FIG.6C in an unlocked position according to one or more embodiments described herein.

[0025] FIGS. 7A, 7B, and 7C depict interior cross-section views of the example medical injection device with the lock of FIGS. 6A-6E and a translation lock according to one or more embodiments described herein.

[0026] FIGS. 8 A and 8B depict an exterior bottom view of an example medical injection device in a locked position and an unlocked position, respectively, and FIG. 8C depicts a crosssection side view of an example medical injection device according to one or more embodiments described herein.9MEI 48657880v.1

[0027] FIGS. 9A and 9B depict partial bottom views of an example medical injection device in a locked position and an unlocked position, respectively, according to one or more embodiments described herein.

[0028] FIGS. 10A and 10B depict partial cross-section side views of an example medical injection device in a locked position and an unlocked position, respectively, according to one or more embodiments described herein.

[0029] FIGS. 11A and 11B depict partial cross-section side views of an example medical injection device in a locked position and an unlocked position, respectively, according to one or more embodiments described herein.

[0030] FIGS. 12A and 12B depict partial cross-section side views of an example medical injection device in a locked position and an unlocked position, respectively, along lines 12A-12A’ and 12B-12B’ in FIGS. 9A and 9B, respectively, according to one or more embodiments described herein.

[0031] FIGS. 13 A and 13B depict partial top views of an example medical injection device in a locked position and an unlocked position, respectively, according to one or more embodiments described herein.

[0032] FIGS. 14A and 14B depict partial cross-section side views of an example medical injection device in a locked position and an unlocked position, respectively, according to one or more embodiments described herein.

[0033] FIGS. 15A and 15B depict partial top views of an example medical injection device in a locked position and an unlocked position, respectively, according to one or more embodiments described herein.10MEI 48657880v.1

[0034] FIG. 16 depicts an exterior top view of an example medical injection device with a needle lock according to one or more embodiments described herein.

[0035] FIGS. 17A and 17B depict interior cross-section views of an example medical injection device with a needle lock in a locked state according to one or more embodiments described herein.

[0036] FIG. 18 depicts an interior cross-section view of an example medical injection device with a needle lock having insertion directional support features according to one or more embodiments described herein.

[0037] FIGS. 19A and 19B depict partial cross-section side views of an example medical injection device in a locked position and an unlocked position, respectively, according to one or more embodiments described herein.

[0038] FIGS. 20 A and 20B depict partial cross-section side views of an example medical injection device in a locked position and an unlocked position, respectively, according to one or more embodiments described herein.

[0039] FIG. 21 A depicts a partial exterior perspective view of the distal portion of the example medical injection device according to one or more embodiments described herein.

[0040] FIG. 21 B depicts a partial interior cross-section view along line 21B-21B’ in FIG.21 A of the example medical injection device according to one or more embodiments described herein.

[0041] FIG. 21 C depicts a zoomed-in partial interior cross-section view of portion 21 C in FIG. 21B of the example medical injection device according to one or more embodiments described herein.11MEI 48657880v.1

[0042] FIG. 22 depicts an example environment for using an example medical injection device according to one or more embodiments described herein.

[0043] FIG. 23 depicts an example computer apparatus for use with one or more embodiments described herein.

[0044] FIGS. 24 A and 24B (collectively FIG. 24) depict an example flowchart for a method for medical injection of using an example injection device according to one or more embodiments described herein.

[0045] FIG. 25 depicts an example flowchart for a method of using an example injection device according to one or more embodiments described herein.

[0046] FIG. 27 depicts an example flowchart for a method for medical injection with injection lockout of using an example injection device according to one or more embodiments described herein.DETAILED DESCRIPTION EXAMPLE NESTED HANDLE MEDICAL INJECTION SYSTEM

[0047] To treat certain tumors, a drug may need to be injected directly into the tumor. In some cases, the tumor may not be easily accessible using conventional techniques, such as a tumor in the lungs. To access such a tumor, a needle may need to travel a long and winding path to reach the tumor and, in doing so, may travel through a working channel to reach the subject. In some embodiments, a working channel may be a tube-like apparatus (typically made of soft and / or pliable material) having a proximal opening, a distal opening, and an interior connecting the proximal opening and the distal opening, and in use, the distal end of the working channel having the distal opening may be inserted into a subject to perform a medical procedure on the 12MEI 48657880v.1subject, such as, for example, inserting one or more medical instruments (e.g., a needle, a camera, etc.) from the proximal opening to the distal opening of the working channel. As examples, a working channel may be a scope working channel (e.g., a bronchoscope working channel), an extended working channel, a robotic working channel, or a medical procedure device have a working channel.

[0048] Further, while traveling such a long and winding path through the working channel to reach the tumor, the needle should avoid unintentionally puncturing the working channel, as well as body parts of the subject. Once the tumor is reached by the needle, the needle may need to puncture the tumor, which may be more resistant to puncture than surrounding tissue. Prior to inserting the needle in the tumor, the tip at the distal end of the needle should be in an unmoving position relative to the tumor so that the location of the needle tip may be confirmed by the user to ensure that the needle tip is in a desired position. To confirm the position of the tip of the needle, the user may obtain an image of the interior of the subject. After inserting the tip of the needle in the tumor and prior to starting the injection, the tip at the distal end of the needle should again be in an unmoving position relative to the tumor so that the location of the needle tip may be confirmed by the user to ensure the needle tip is in a desired position. To confirm the position of the tip of the needle, the user may obtain an image of the interior of the subject. During injection, the tip at the distal end of the needle should be in an unmoving position relative to the tumor to minimize risk of mistakenly injecting the drug outside the tumor. During injection, the tip at the distal end of the needle may need to be in an unmoving position relative to the tumor for a long time compared to a routine arm injection (e.g., for a flu shot). For example, according to some data collection, 49% to 76% of tumors require an injection time of 4 minutes or longer, and 27% to 49% of tumors require an injection time of 19 minutes or longer.13MEI 48657880v.1

[0049] As discovered by the inventors, a nested handle medical injection system may address such concerns for injecting a medical substance (e.g., a fluid, solid, pellet, gel, medicant, or drug) into a hard-to-reach tumor. By using a nested handle medical injection system disclosed herein, a user (e.g., a physician, surgeon, or medical practitioner) may readily be able, for example: to control the needle as the needle travels a long and winding path through a working channel to reach the tumor; to avoid having the needle puncture the working channel and possibly the subject while traveling through the working channel; to place the tip at the distal end of the needle in an unmoving position relative to the tumor so as to confirm the location of the tip of the needle prior to insertion of the tip of the needle into the tumor; to insert the tip at the distal end of the needle into the tumor; to place the tip at the distal end of he needle in an unmoving position relative to the tumor so as to confirm the location of the tip of the needle after insertion of the tip of the needle into the tumor and prior to injection of the medical substance into the tumor; to place the tip at the distal end of the needle in an unmoving position relative to the tumor during the injection of the medical substance and for possibly a long period of time (e.g., more than 4 minutes, or more 19 minutes, or longer); and / or to safely withdraw the tip of the needle from the tumor and out of the subject.

[0050] As discovered by the inventors, such a nested handle medical injection system may be used to inject a medical substance. The nested handle medical injection system may be used to inject a medical substance in conjunction with and / or as part of a working channel, where the working channel may or may not include an adapter for attaching the nested handle medical injection system to the working channel. In some embodiments, the nested handle medical injection system may be used to inject a medical substance in conjunction with and / or as part of a medical procedure device having a working channel.14MEI 48657880v.1

[0051] 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. FIGS. 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.

[0052] 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 needle 50 in an unmoving position in the axial direction 15MEI 48657880v.1so 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 needle 50 in an unmoving position in the axial direction during the injection of the medical substance; and / or to safely withdraw the tip of the needle 50 from the tumor and out of the subject.

[0053] The handle 110 may be configured 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.

[0054] 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.

[0055] 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 16MEI 48657880v.1substance 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 the sheath 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.

[0056] 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 17MEI 48657880v.1a longitudinal direction 113 of the handle 110 relative to the second tubular member 20 and the sheath 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.

[0057] 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.

[0058] 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 40.18MEI 48657880v.1

[0059] 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, symbols, 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.

[0060] 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.

[0061] 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 19MEI 48657880v.1of 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 the longitudinal 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.

[0062] 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.20MEI 48657880v.1

[0063] 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, and 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.

[0064] 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.

[0065] 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 21MEI 48657880v.1sheath 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, in 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.

[0066] 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.

[0067] 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 22MEI 48657880v.1be 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 connect the 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.

[0068] 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.

[0069] 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 23MEI 48657880v.162 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 the working channel, so as to limit rotation of the handle 110 relative to the working channel or instrumentation.

[0070] 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.

[0071] FIGS. 4A, 4B, 4C, and 4D depict a lock 25 for the example medical injection device 100 according to one or more embodiments described herein. FIG. 4A depicts a partial exterior top view of portion 4A in FIG. 2A, and FIG. 4B depicts an interior cross-section view of portion 4B in FIG. 2B of the example medical injection device 100 with a lock 25 in a locked position according to one or more embodiments described herein. The injection device 100 may have a plurality of nested tubular members. For example, the plurality of nested tubular members may include a second tubular member 20 and a third tubular member 30. The plurality of nested tubular members may be user operable to move independently of each other. Additionally, the plurality of nested tubular members may be user operable to independently extend and retract the needle 50 and the sheath 40 from the medical procedure device. In an embodiment, the sheath 40 may be connected to an interior of a tubular member (e.g., third tubular member 30).

[0072] The lock 25 may be configured to prevent the sheath 40 from extending and retracting from the medical injection device 100 and to permit the sheath 40 to extend and retract from the medical injection device 100. Additionally, the lock 25 may be configured to communicate at least two operating conditions of the lock 25. The lock 25 may include a body 251 that is connected to, integrated into, or part of the second tubular member 20. The second tubular 24MEI 48657880v.1member 20 may include lock 25 to lock and unlock two tubular members of the plurality of nested tubular members. For example, lock 25 may be configured to lock and unlock the second tubular member 20 with respect to the third tubular member 30. In an embodiment, the third tubular member 30 may be nested in the second tubular member 20. Further, the third tubular member 30 may be configured to secure and unsecure the handle to the medical procedure device (e.g., a working channel). The lock 25 may include a coupling collar 252. The coupling collar 252 may define a channel 253 to receive a thumb screw 254. The channel 253 may include coupling threads configured to engage threads formed on the thumb screw 254 to allow the thumb screw 254 to move and switch the lock 625 between the at least two operating conditions.

[0073] The lock 25 may be user operable by the thumb screw 254 to switch between the at least two operating conditions of the lock 25. In a first operating condition of the at least two operating conditions, the lock 25 may be in a locked position where the lock 25 and / or the thumb screw 254 engage with a nested tubular member of the plurality of tubular members while in a locked position. For example, in a locked position, the thumb screw 254 may engage with the third tubular member 30. While in the locked position, the thumb screw 254 may press against an outer portion of a tubular member to lock together two tubular members of the plurality of nested tubular members. For example, in a locked position, the thumb screw 254 may press against an outer portion of third tubular member 30 to lock together the second tubular member 20 and third tubular member 30 and prevent movement of the second tubular member 20 and third tubular member 30 relative to each other. Additionally, when the lock 25 and / or thumb screw 254 is / are in the locked position, the sheath may be in a locked position and the sheath 40 may be prevented from moving.25MEI 48657880v.1

[0074] FIG. 4C depicts a partial exterior top view of portion 4C in FIG. 2A, and FIG. 4D depicts an interior cross-section view of portion 4D in FIG. 2B of the example medical injection device in an unlocked position according to one or more embodiments described herein. As described above, the lock 25 may be user operable by the thumb screw 254 to switch between the at least two operating conditions of the lock 25. In a second operating condition of the at least two operating conditions, the lock 25 may be in an unlocked position where the lock 25 and / or the thumb screw 254 disengage from a nested tubular member of the plurality of tubular members. For example, in the locked position, the thumb screw 254 may disengage with the third tubular member 30. While in the unlocked position, the thumb screw 254 may not press against an outer portion of a tubular member to unlock two tubular members of the plurality of nested tubular members from each other. For example, in the unlocked position, the thumb screw 254 may be disengaged from an outer portion of third tubular member 30 to unlock the second tubular member 20 and third tubular member 30 to allow movement of the second tubular member 20 and third tubular member 30 relative to each other. Additionally, when the lock 25 and / or thumb screw 254 is / are in the unlocked position, the sheath may be in an unlocked position and the sheath 40 may be permitted to move.

[0075] FIGS. 5A and 5B depict a lock 25 for the example medical injection device 100 according to one or more embodiments described herein.

[0076] FIG. 5A depicts a partial exterior top view of lock 25 in a locked position and FIG.5B depicts a partial exterior top view of the lock 25 in an unlocked position according to one or more embodiments described herein. In an embodiment, the lock 25 may be configured to communicate at least two operating conditions of the lock 25, as described above. The lock 25 may include a shroud 255 partially covering the thumb screw 254. The shroud 255 may be 26MEI 48657880v.1integral with body 251 and / or coupling collar 252. The shroud 255 may define a visual indicator viewing window 256.

[0077] As described above, the lock 25 may be user operable by the thumb screw 254 to switch between a first operation condition where the lock 25 is in a locked position, and a second operation condition where the lock 25 is in an unlocked position. The lock 25 may comprise a first visual indicator 257a to indicate the locked position of the lock 25. The first visual indicator 257a may include a color coding (e.g., green when in a locked position), a symbol (e.g., a locked lock symbol), and the like. The first visual indicator 257a may be printed, formed, drawn, and the like on a first portion of thumb screw 254. Additionally, the lock 25 may comprise a second visual indicator 257b to indicate the unlocked position of the lock 25. The second visual indicator 257b may include a color coding (e.g., red when in an unlocked position), a symbol (e.g., an unlocked lock symbol), and the like. The second visual indicator 257b may be printed, formed, drawn, and the like on a second portion of thumb screw 254. In an embodiment, the lock 25 may comprise thumb screw 254, and shroud 255 may partially cover the thumb screw 254. The shroud 255 may partially cover the thumb screw 254 such that when the first visual indicator 257a is visible, the second visual indicator 257b may be hidden from view by the shroud 255, as shown in FIG. 5A. Additionally, the shroud 255 may partially cover the thumb screw 254 such that when the second visual indicator 257b is visible, the first visual indicator 257a may be hidden from view by the shroud 255, as shown in FIG. 5B. The first visual indicator 257a and second visual indicator 257b may be used to allow medical professional to quickly and easily determine an operation condition of the lock 625 and when the sheath 40 is locked into position to allow for translation of the needle 50 without undesired movement of the sheath 40.27MEI 48657880v.1

[0078] FIGS. 6A, 6B, 6C, 6D, and 6E depict a lock 625 for the example medical injection device 100 according to one or more embodiments described herein.

[0079] FIG. 6A depicts a partial exterior perspective view of the example medical injection device with a lock 625 in a locked position. FIG. 6D depicts a partial interior cross-section perspective view of the lock 625 in a locked position according to one or more embodiments described herein. The injection device 100 may have a plurality of nested tubular members. For example, the plurality of nested tubular members may include second tubular member 20 and third tubular member 30. The plurality of nested tubular members may be user operable to move independently of each other. Additionally, the plurality of nested tubular members may be user operable to independently extend and retract the needle 50 and the sheath 40 from the medical procedure device. In an embodiment, the sheath 40 may be connected to an interior of a tubular member (e.g., third tubular member 30).

[0080] The lock 625 may be configured to prevent the sheath 40 from extending and retracting from the medical injection device 100 and to permit the sheath 40 to extend and retract from the medical injection device 100. Additionally, the lock 625 may be configured to communicate at least two operating conditions of the lock 625. The lock 625 may include a body 6251 that is connected to, integrated into, or part of a tubular member (e.g., the second tubular member 20). The second tubular member 20 may include lock 625 to lock and unlock two tubular members of the plurality of nested tubular members. For example, lock 625 may be configured to lock and unlock the second tubular member 20 with respect to the third tubular member 30. In an embodiment, the third tubular member 30 may be nested in the second tubular member 20. Further, the third tubular member 30 may be configured to secure and unsecure the handle to the medical procedure device (e.g., a working channel). The lock 625 may include a 28MEI 48657880v.1coupling collar 6252. The coupling collar 6252 may define an aperture 6253 to receive a cam 6254, shown in FIGS. 6D and 6E. The lock 625 may comprise a cam lever 6255 to engage and disengage with the cam 6254 to move the cam 6254 back and forth, as shown by arrow 6256, and switch the lock 625 between the at least two operating conditions.

[0081] The lock 625 may be user operable by the cam lever 6255 to switch between the at least two operating conditions of the lock 625. In a first operating condition of the at least two operating conditions, the lock 625 may be in a locked position where the cam lever 6255 is positioned substantially parallel to the medical injection device 100, as shown in FIGS. 6A and 6D. In the locked position, the cam 6254 may be pushed into aperture 6253 and be engaged with a nested tubular member of the plurality of tubular members while in a locked position. For example, in a locked position, the cam 6254 may engage with the third tubular member 30. While in the locked position, the cam 6254 may be pressed against an outer portion of a tubular member to lock together two tubular members of the plurality of nested tubular members. For example, in a locked position, the cam 6254 may press against an outer portion of third tubular member 30 to lock together the second tubular member 20 and third tubular member 30 and prevent movement of the second tubular member 20 and third tubular member 30 relative to each other. Additionally, when the cam lever 6255 and / or cam 6254 is / are in the locked position, the sheath 40 may be in a locked position and the sheath 40 may be prevented from moving.

[0082] FIG. 6B depicts a partial exterior perspective view of the example medical injection device 100 with a lock 625 in an unlocked position according to one or more embodiments described herein. FIG. 6C depicts an exterior perspective view of the lock 625 in the unlocked position according to one or more embodiments described herein. FIG. 6E depicts a partial interior cross-section perspective view of the lock 625 in an unlocked position according to one 29MEI 48657880v.1or more embodiments described herein. As described above, the lock 625 may be user operable by the cam lever 6255 to switch between the at least two operating conditions of the lock 625. In a second operating condition of the at least two operating conditions, the lock 625 may be in an unlocked position where the cam lever 6255 is positioned substantially perpendicular to the medical injection device 100, as shown in FIGS. 6B, 6C, and 6E. In the unlocked position, the cam 6254 may be withdrawn from the aperture 6253 and disengage from a nested tubular member of the plurality of tubular members. For example, in the unlocked position, the cam 6254 may disengage from the third tubular member 30. While in the unlocked position, the cam 6254 may not press against an outer portion of a tubular member to unlock two tubular members of the plurality of nested tubular members from each other. For example, in the unlocked position, the cam 6254 may be disengaged from an outer portion of third tubular member 30 to unlock the second tubular member 20 and third tubular member 30 to allow movement of the second tubular member 20 and third tubular member 30 relative to each other. Additionally, when the lock 625 and / or cam lever 6255 is / are in the unlocked position, the sheath 40 may be in a unlocked position and the sheath 40 may be permitted to move.

[0083] As described above, the lock 625 may be user operable by the cam lever 6255 to switch between a first operation condition where the lock 625 is in a locked position, and a second operation condition where the lock 625 is in an unlocked position. The lock 625 may comprise a first visual indicator 6257a to indicate the locked position of the lock 625. The first visual indicator 6257a may be disposed on a first side 6255a of the cam lever 6255. The first visual indicator 6257a may include a color coding (e.g., green when in a locked position), a symbol (e.g., a locked lock symbol), and the like. The first visual indicator 6257a may be printed, formed, drawn, and the like on a first side 6255a of the cam lever 6255. Additionally,30MEI 48657880v.1the lock 625 may comprise a second visual indicator 6257b to indicate the unlocked position of the lock 625. The second visual indicator 6257b may be disposed on a second side 6255b of the cam lever 6255, where the first side 6255a is an opposite side of the cam lever 6255 from the second side 6255b. The second visual indicator 6257b may include a color coding (e.g., red when in an unlocked position), a symbol (e.g., an unlocked lock symbol), and the like. The second visual indicator 6257b may be printed, formed, drawn, and the like on the second side 6255b of cam lever 6255. The first visual indicator 6257a and second visual indicator 6257b may be used to allow medical professional to quickly and easily determine an operation condition of the lock 625 and when the sheath 40 is locked into position to allow for translation of the needle 50 without undesired movement of the sheath 40.

[0084] FIGS. 7A, 7B, and 7C depict interior cross-section views of the example medical injection device 100 with the lock 625 of FIGS. 6A-6E and a translation lock 70 according to one or more embodiments described herein. In an embodiment, the medical injection device may further comprise a translation lock 70. The translation lock 70 may extend between the lock 15 and the lock 625. The translation lock 70 may be configured to engage and disengage with lock 625. The translation lock 70 may be configured to engage and disengage with the lock 625 based on an operation condition of the lock 625. As described above, the lock 625 may be user operable by the cam lever 6255 to switch between a first operation condition where the cam lever 6255 is in a locked position (e.g., cam lever 6255 is substantially parallel to medical injection device 100), and a second operation condition where the cam lever 6255 is in an unlocked position (e.g., the cam lever 6255 is substantially perpendicular to the medical injection device 100). For example, the translation lock 70 may be configured to engage the lock 625 and / or cam lever 6255 when the lock 625 is in the unlocked position. Further, the translation lock 70 may be 31MEI 48657880v.1configured to disengage the lock 625 and / or cam lever 6255 when the lock 625 is in the locked position.

[0085] The translation lock 70 may be configured to lock and unlock the needle 50 from traversing in a distal direction based on the engagement of the translation lock 70 with the lock 625 and / or cam lever 6255. For example, when the translation lock 70 is engaged with the lock 625 and / or cam lever 6255, the translation lock 70 may press against the lock 625 and / or cam lever 6255 to prevent movement of the first tubular member 10 relative to second tubular member 20 and lock the needle 50 from traversing in a distal direction, as shown in FIG. 7A. Further, when the translation lock 70 is disengaged with the lock 625 and / or cam lever 6255, the translation lock 70 may not press against the lock 625 and / or cam lever 6255, as shown in FIG.7B, to allow movement of the first tubular member 10 relative to second tubular member 20, as shown in FIG. 7C, and unlock the needle 50 from traversing in a distal direction. The translation lock 70 may have any suitable geometry such as L-shaped, as shown in FIGS. 7A-7C, curved, angled, and the like to engage and disengage with the lock 625, as described above. The translation lock 70 may be used to allow a medical professional to quickly and easily prevent extension of the needle 50 without locking the sheath 50 in position. The engagement of the translation lock 70 may also be used to communicate when the sheath 40 is locked into position to allow for translation of the needle 50 without undesired movement of the sheath 40.EXAMPLE NEEDLE LOCK

[0086] To treat certain tumors with an injection substance injected directly into a tumor, it may desirable for the tip at the distal end of the needle injecting the injection substance to be unmoving and maintain its position with respect to the tumor during the injection. To do so, the 32MEI 48657880v.1position of the tip of the needle relative to the tumor should be maintained once the needle is moved into the tumor, and the needle, once placed in the tumor, needs to support loads in both the proximal and distal directions of the needle. During injection, forces against the needle may be applied by the injection substance being pushed through the needle from the proximal end to the distal end and applied as resistance in the tumor to receiving the injection substance. When the injection substance is solid or semi-solid, a dispersion diffusion might not occur as with a fluid, and as such, the needle may be experience additional force against the needle as the solid or semi-solid is being injected into the tumor. Moreover, to maintain the position of the needle, rotation of the needle may be undesirable, and non-rotation of the needle may be desirable. Using a needle in such a way is much different from using a needle for a biopsy where a user repeatedly jabs to the needle into and out of tissue of the subject to obtain a tissue sample.

[0087] As discovered by the inventors, a nested handle medical injection system according to this disclosure may address such concerns for locking a needle in place during injection of the injection substance. By using the inventive nested handle medical injection system having a needle lock: the needle may be locked in position during injection; the needle may withstand the forces incurred during injection of the injection substance without changing position, without moving in a longitudinal direction, and / or without moving in a rotational direction; and / or the needle may be locked in position and not be subject to pressure changes as the injection substance is injected into the subject.

[0088] FIGS. 8 A and 8B depict an exterior bottom view of the example medical injection device 100 in a locked position and an unlocked position, respectively. To lock and unlock the needle 50, the handle 100 may include a lock (a needle lock, or a nested tubular lock) 15 configured to prevent the needle from moving proximally and distally. The lock 15 may be user 33MEI 48657880v.1operable to move or slide back-and-forth between a locked position (FIG. 8A) and an unlocked position (FIG. 8B). When the lock 15 is in the locked position, the needle 50 may be in a locked position and prevented from moving proximally and distally relative to the sheath 40 and / or working channel, and when the lock 15 is in the unlocked position, the needle 50 may be in an unlocked position and permitted to move proximally and distally relative to the sheath 40 and / or working channel. When the lock 15 is in the locked position, the needle 50 may be prevented from being extended and retracted from the distal end 42 of the sheath 40, and when the lock 15 is in the unlocked position, the needle 50 may be permitted to be extended and retracted from the distal end 42 of the sheath 40.

[0089] The lock 15 may be configured to lock and unlock together two nested tubular members (e.g., the first tubular member 10 and the second tubular member 20). The lock 15 may be movable or slidable between a locked position to lock together the two tubular members (e.g., the first tubular member 10 and the second tubular member 20) and an unlocked position to unlock together the two tubular members (e.g., the first tubular member 10 and the second tubular member 20). When the lock 15 is in the locked position, the two tubular members (e.g., the first tubular member 10 and the second tubular member 20) may be locked together and prevented from moving independently of each other, and when the lock 15 is in the unlocked position, the two tubular members (e.g., the first tubular member 10 and the second tubular member 20) may be unlocked from each other and permitted to move independently of each other. When the lock 15 is in either the locked position or the unlocked position, the third tubular member 30 may not be locked together with the two tubular members (e.g., the first tubular member 10 and the second tubular member 20) by the lock 15, and movement of the third tubular member 30 may not be hindered by the lock 15.34MEI 48657880v.1

[0090] In FIGS. 8 A and 8B, the bottom side 114 of the handle 100 is visible. In FIG. 8 A, the first tubular member 10 is fully extended relative to the second tubular member 20, the needle 50 is fully retracted into the sheath 40, the second tubular member 20 is fully retracted relative to the third tubular member 30, and the sheath 40 is fully extended. This may be the position of the handle 110 before and after the sheath 40 has been extended to the tumor. At a time between FIG. 8 A and FIG. 8B, the lock 15 may be moved from a locked position as in FIG. 8A to an unlocked position as in FIG. 8B. In FIG. 8B, the first tubular member 10 is partially retracted relative to the second tubular member 20, the needle 50 is partially extended relative to the sheath 40, the second tubular member 20 is fully retracted relative to the third tubular member 30, and the sheath 40 is fully extended. This may be the position of the handle 110 after the sheath 40 has been extended to the tumor and the needle 50 is in position for injection, and once the needle 50 is in position for injection, the lock 15 may be moved from the unlocked position to the locked position. As the second tubular member 20 is fully retracted in FIGS. 8A and 8B, the third tubular member 30 is not visible as being fully nested within the second tubular member 20.

[0091] As depicted in FIGS. 8 A and 8B, the handle may include the lock 25 to lock and unlock the second tubular member 20 with respect to the third tubular member 30. The lock 15 and the lock 25 may be operated independently of each other. The lock 15 and the lock 25 may have different modes of operation. For example, the lock 15 may be operated by sliding or pushing a member (e.g., the slide member or slide 440), and the lock 25 may be operated by turning a thumb screw. Having different modes of operation for these two locks 15, 25 may be beneficial for a user so as to avoid confusion as to which lock is being operated by the user. However, it will also be understood that, in alternative examples, the two locks 15 and 25 can 35MEI 48657880v.1have the same mode of operation (i.e., both can have the slide member 440, the thumb screw, or another type of lock).

[0092] FIG. 8C depicts a cross-section side view of the example medical injection device 100 according to one or more embodiments described herein. In FIGS. 8C, the bottom side 114 and the top side 115 of the handle 100 are visible. FIGS. 9A to 12B depict detail views of the lock 15. FIGS. 9A and 9B depict partial bottom views of the example medical injection device 100 in a locked position and an unlocked position, respectively, according to one or more embodiments described herein. FIGS. 10A and 10B depict partial cross-section side views of the example medical injection device 100 in a locked position and an unlocked position, respectively, according to one or more embodiments described herein. FIGS. 11A and 11B depict partial cross-section side views of the example medical injection device 100 in a locked position and an unlocked position, respectively, according to one or more embodiments described herein. FIGS. 12A and 12B depict partial cross-section side views of the example medical injection device 100 in a locked position and an unlocked position, respectively, along lines 12A-12A’ and 12B-12B’ in FIGS. 9 A and 9B, respectively, according to one or more embodiments described herein.

[0093] The lock 15 may include a slide member or slide 440 attached to a first tubular member 10. In some embodiments, the slide member 440 may be a slide tab or a slidable annular member (e.g., a ring). The slide member 440 may be configured to slide between a locked position (e.g., FIGS. 8 A, 9A, 10A, 11 A, and 12A) and an unlocked position (e.g., FIGS.8B, 9B, 10B, 1 IB, and 12B). The lock 15 may be operated to lock the needle 50 in position by sliding the slide member 440 from an unlocked position to a locked position and may be operated to unlock the needle 50 by sliding the slide member 440 from a locked position to an 36MEI 48657880v.1unlocked position. When the slide member 15 is in the locked position, the needle 50 is in a locked position and prevented from moving, and when the slide member 15 is in the unlocked position, the needle 50 is in an unlocked position and permitted to move.

[0094] The lock 15 may further include a plurality of teeth 450 integrated into or part of the second tubular member 20. The teeth 450 may be on an exterior of the second tubular member 20, such as on the back side 115 of the second tubular member 20 as depicted in FIGS. 8 A and 8B. The teeth 450 may be, for example, a row of teeth or a rack of teeth. The slide member 440 may be configured to engage and disengage the teeth 450 of the second tubular member 20, which is nested within the first tubular member 10. When the slide member 440 is in a locked position, the slide member 440 may be engaged with the teeth 450 of the second tubular member 20, and when the slide member 440 is in an unlocked position, the slide member 440 may not be engaged with the teeth 450 of the second tubular member 20.

[0095] As depicted in FIGS. 9A, 9B, 12A, and 12B, the slide member 440 may include a first portion 510 and a second portion 520 opposite the first portion 510. The first portion 510 can extend further outward from the first tubular member 10 when in the locked position than when in the unlocked position. In some examples, such as the example shown, the first portion 510 may be visible or exposed when the slide member 440 is in a locked position and not visible or unexposed when the slide member 440 is in an unlocked position. In other examples, the first portion 510 can be visible or exposed in the locked and unlocked positions. Opposite to the first portion 510, the second portion 520 can extend further outward from the first tubular member 10 when in the unlocked position than when in the locked position. In some examples, such as the example shown, the second portion 520 may not visible or unexposed when the slide member 440 is in a locked position and visible or exposed when the slide member 440 is in an unlocked 37MEI 48657880v.1position. In other examples, the second portion 520 can be visible or exposed in the locked and unlocked positions.

[0096] As also depicted in FIGS. 9A, 9B, 12A, and 12B, the slide member 440 may include a first end face 512 and a second end face 522 opposite the first end face 512. The first end face 512 may be visible or exposed when the slide member 440 is in both the locked position and the unlocked position, and the second end face 522 may be visible or exposed when the slide member 440 is in both the locked position and the unlocked position.

[0097] As depicted in FIGS. 8A, 8B, 9A, 9B, 10A, 10B, 11A, and 1 IB, the lock may include an end ring 445 at the distal end 12 of the first tubular member 10. In some embodiments, the first tubular member may include two halves that are clamped together and secured by the end ring 445. The first portion 510 may be covered by the end ring 445 when the slide member 440 is in the locked position so as to be not visible or unexposed and may not be covered by the end ring 445 when the slide member 440 is in the unlocked position so at to be visible or exposed. The second portion 510 may not be covered by the end ring 445 when the slide member 440 is in the locked position so as to be visible or exposed and may be covered by the end ring 445 when the slide member 440 is in the unlocked position so at to be not visible or unexposed.

[0098] As depicted in FIGS. 12A and 12B, the slide member 440 of the lock 15 may include an opening 830, where the needle 50 extends through the opening 830 of the slide member 15. The needle 50 may extend through the opening 830 of the slide member 15 without touching the slide member 440 in the locked position, in the unlocked position, and while moving back-and-forth between the locked and unlocked positions.

[0099] The slide member 440 may further include a tooth 610 to engage with the teeth 450 on the exterior of the second tubular member 20. The tooth 610 can be disposed within the 38MEI 48657880v.1opening 830. As depicted in FIGS. 10A, 11A, and 12A, the slide member 440 is in a locked position, and the tooth 610 of the slide member 440 is engaged with the teeth 450. As the slide member 440 is moved or slid into the locked position, the tooth 610 slides between two teeth 450. With the slide member 440 engaged as such, the first tubular member 10 is prevented from moving with respect to the second tubular member 20, and the needle 50 is in a locked position. To move from the locked position to the unlocked position, the slide member 440 is slid in the direction of arrow 810 in FIG. 12A, and the tooth 610 is disengaged with the teeth 450. As depicted in FIGS. 10B, 1 IB, and 12B, the slide member 440 is in an unlocked position, and the tooth 610 of the slide member 440 is not engaged with the teeth 450. With the slide member 440 engaged as such, the first tubular member 10 is permitted to move with respect to the second tubular member 20, and the needle 50 is in an unlocked position. To move from the unlocked position to the locked position, the slide member 440 is slid in the direction of arrow 820 in FIG.12B, and the tooth 610 is engaged with the teeth 450.

[0100] As depicted in FIGS. 10A, 10B, 12A, and 12B, the slide member 440 may be frictionally held in position by the end ring 445 and a distal portion 620 of the first member 10. The slide member 440 may have a snug fit and not a loose fit such that a force from the user (e.g., pushing or pressing by the user’s thumb or finger) is needed to move the slide member 440 back-and-forth between the locked position, and the unlocked position. To assist the user in applying a sufficient force to move the slide member 440, the first tubular member 10 may have a textured grip 416 (FIGS. 8A, 8B, 8C, 9A, and 9B). For example, the first tubular member 10 may include a two-shot or over-molded rubber exterior.

[0101] To further stiffen and stabilize the needle 50 to withstand the forces and pressures from injecting the injection substance, the handle 110 may include guide rails 410 and needle 39MEI 48657880v.1supports 412, as depicted in FIG. 8C. The guide rails 410 may be incorporated in the first tubular member 10 and may allow for easy gliding of the first tubular member 10 over the second tubular member 20 when the needle 50 is extended and retracted. For instance, in some examples, the guide rails 410 may engage an outer surface of the second tubular member 20 to guide movement of the first and second tubular members 10, 20 relative to one another. The needle supports 412 may be incorporated in the first tubular member 10 and may include two telescoping tubes to support the needle 50 and the needle lumen 53 in the handle 110. For instance, in some examples, the needle supports 412 in the first tubular member 10 may include an inner needle support surrounding the needle 50, and the needle supports 412 in the second tubular member 20 may include an outer needle support surrounding the inner needle support. The needle supports 412 may slidably interact with each other as the first tubular member 10 and the second tubular member 20 are moved distally and proximally relative to one another.EXAMPLE OPERATIVE COMMUNICATION FOR NEEDLE LOCK

[0102] As discovered by the inventors, when locking and unlocking a needle 50 using the inventive medical injection device 100 having a nested handle 110, a user of the medical injection device 100 may desirably need to know the operating condition of the medical injection device 100. To provide such a desired operative communication to the user of the medical injection device 100, the inventors discovered that one or more visual indicators, one or more tactile indicators, and / or one or more audible indicators may be included with the medical injection device 100 to indicate the operating condition of the medical injection device 100 and / or a change in the operating condition of the medical injection device 100.40MEI 48657880v.1

[0103] FIGS. 13 A and 13B depict partial top views of the example medical injection device 100 in a locked position and an unlocked position, respectively, according to one or more embodiments described herein. FIGS. 14A and 14B depict partial cross-section side views of the example medical injection device 100 in a locked position and an unlocked position, respectively, according to one or more embodiments described herein.

[0104] The lock 15, which is configured to prevent the needle 50 from moving and to permit the needle 50 to move, may operatively communicate to a user of the medical injection device 100 at least two operating conditions of the lock 15. For example, the at least two operating conditions of the lock 15 may include a locked condition and an unlocked condition of the lock 15. The lock 15 may include a first operating condition (e.g., a locked position, a locked condition, or a locked operating condition) and a second operating condition (e.g., an unlocked position, an unlocked condition, or an unlocked operating condition) different from the first operating condition and may include a first user communicative indicator and a second user communicative indicator different from the first user communicative indicator, where the first and second user communicative indicators correspond to the first and second operating conditions of the lock 15, respectively. The first operating condition may include the first tubular member 10 and the second tubular member 20 being locked together by the lock 15, and the second operating condition may include the first tubular member 10 and the second tubular member 20 being unlocked by the lock 15. As such, the first and second operating conditions of the lock 15 may include the lock 15 being configured to lock and unlock together the first tubular member 10 and the second tubular member 20.

[0105] In the first operating condition of the lock 15, the lock 15 may be in a locked position, and the needle 50 may be in a locked position and prevented from moving. To obtain the first 41MEI 48657880v.1operating condition of the lock 15, the lock 15 may be operated (e.g., moved, pushed, or slid) by the user from an unlocked position to a locked position. In the second operating condition of the lock 15, the lock 15 may be in an unlocked position, and the needle 50 may be in an unlocked position and permitted to move. To obtain the second operating condition of the lock 15, the lock may be operated (e.g., moved, pushed, or slid) by the user from the locked position to the unlocked position.

[0106] The first user communicative indicator and a second user communicative indicator of the lock 15 may operatively communicate to the user the operating condition and / or change in operating condition of the needle 50. The first user communicative indicator of the lock 15 may operatively communicate to the user a first operating condition (e.g., a locked position, a locked condition, or a locked operating condition) of the needle 50, where the needle 50 is in an unlocked position. The second user communicative indicator of the lock 15 may operatively communicate to the user a second operating condition (e.g., an unlocked position, an unlocked condition, or an unlocked operating condition) of needle 50, where the needle 50 is in an unlocked position. In some embodiments, the first user communicative indicator of the lock 15 may operatively communicate to the user that the needle 50 is moving from the second operating condition (e.g., locked position) to the first operating condition (e.g., unlocked position). In some embodiments, the second user communicative indicator of the lock 15 may operatively communicate to the user that the needle 50 is moving from the first operating condition (e.g., unlocked position) to the second operating condition (e.g., locked position).

[0107] The user communicative indicators may include one or more visual indicators, one or more tactile indicators, and / or one or more audible indicators. In some embodiments, the first42MEI 48657880v.1and second user communicative indicators may include at least one of a pair of visual indicators, a pair of tactile indicators, or a pair of audible indicators.

[0108] In some embodiments, referring to FIGS. 13A, 13B, 14A, and 14B, the first user communicative indicator may include at least one of a first visual indicator 902, a first tactile indicator 908, or a first audible indicator 922 to indicate the first operating condition, and the second user communicative indicator may include at least one of a second visual indicator 912, a second tactile indicator 918, or a second audible indicator 932 to indicate the second operating condition, where the first user communicative indicator and the second user communicative indicator are different. As an example, the first user communicative indicator may include at least one of a first visual indicator 902 or a first tactile indicator 908 for the locked position, and the second user communicative indicator may include may include at least one of a second visual indicator 912 or a second tactile indicator 918 for the locked position, where the first visual indicator 902 and the second visual indicator 912 are different, and where the first tactile indicator 908 and the second tactile indicator 918 are different.

[0109] In some embodiments having at least one visual indicator (or visual indicia), such as depicted in FIGS. 13 A and 13B, the lock 15 may include a first visual indicator 902 and / or a second visual indicator 912 that differ by at least one of symbol or color. For example, the first visual indicator 902 may be a locked padlock symbol and / or the color red, and the first visual indicator 902 may be located on a proximal face 904 and / or a distal face 906 of the first portion 510 of the slide member 440 but not on the first end face 512 of the slide member 440. For example, the second visual indicator 912 may be an unlocked padlock symbol and / or the color green, and the second visual indicator 912 may be located on a proximal face 914 and / or a distal43MEI 48657880v.1face 916 of the second portion 520 of the slide member 440 but not on the second end face 522 of the slide member 440.

[0110] When the lock 15 is in a locked position, the lock 15 may display the first visual indicator 902 but not the second visual indicator 912, and the needle 50 may be in a locked position and prevented from moving. In some embodiments, when the lock 15 is in the locked position, the first visual indicator 902 may be visible to a user of the medical injection device 100, and the second visual indicator 912 may not be visible to a user of the medical injection device 100. When the lock 15 is in an unlocked position, the lock 15 may display the second visual indicator 912 but not the first visual indicator 902, and the needle 50 may be in an unlocked position and permitted to move. In some embodiments, when the lock 15 is in the unlocked position, the first visual indicator 902 may not be visible to a user of the medical injection device 100, and the second visual indicator 912 may be visible to a user of the medical injection device 100.

[0111] In some embodiments having at least one tactile indicator, such as depicted in FIGS.13A, 13B, 14A, and 14B, the lock 15 may include a first tactile indicator 908 and / or a second tactile indicator 918, where the first tactile indicator 908 and the second tactile indicator 918 are different. For example, the first tactile indicator 908 may include the proximal face 904 and / or the distal face 906 of the slide member 440, and the second tactile indicator 918 may include the proximal face 914 and / or the distal face 916 of the slide member 440.

[0112] When the lock 15 is in a locked position, the lock 15 may provide the first tactile indicator 908 but not the second tactile indicator 918, and the needle 50 may be in a locked position and prevented from moving. In some embodiments, when the lock 15 is in the locked position, the first tactile indicator 908 may be felt or touched by a user of the medical injection 44MEI 48657880v.1device 100, and the second tactile indicator 918 may be hidden and not able to be felt or touched by a user of the medical injection device 100. For example, when the lock 15 is in the locked position, the first tactile indicator 908 may protrude from a first side of the first tubular member 10, and the second tactile indicator 918 may be recessed in and flush with a second side of the first tubular member 10, where the first side of the first tubular member 10 is opposite the second side of the first tubular member 10.

[0113] When the lock 15 is in an unlocked position, the lock 15 may provide the second tactile indicator 918 but not the first tactile indicator 908, and the needle 50 may be in an unlocked position and permitted to move. In some embodiments, when the lock 15 is in the unlocked position, the first tactile indicator 908 may be hidden and not able to be felt or touched by a user of the medical injection device 100, and the second tactile indicator 918 may be felt or touched by a user of the medical injection device 100. For example, when the lock 15 is in the unlocked position, the first tactile indicator 908 may be recessed in and flush with a first side of the first tubular member 10, and the second tactile indicator 918 may protrude from a second side of the first tubular member 10, where the first side of the first tubular member 10 is opposite the second side of the first tubular member 10.

[0114] In some embodiments having at least one audible indicator, such as depicted in FIGS.14A and 14B, the lock 15 may include a first audible indicator 922 and / or a second audible indicator 932, where the first audible indicator 922 and the second audible indicator 932 may be different. For example, the first audible indicator 922 may include a detent 924 on a proximal side of the slide member 440 interacting with a second indent 928 on the first tubular member 10 and then a first indent 926 on the first tubular member 10. For example, the second audible indicator 922 may include the detent 924 on a proximal side of the slide member 440 interacting 45MEI 48657880v.1with the first indent 926 on the first tubular member 10 and then the second indent 928 on the first tubular member 10.

[0115] When the lock 15 moves from the unlocked position to the locked position, the needle 50 may move from a locked condition to an unlocked condition, and the lock 15 may make a first audible sound with the first audible indicator 922 but not a second audible sound with the second audible indicator 932. As the slide member 440 is moved from an unlocked position to a locked position as indicated by the arrow 820 in FIG. 14B, a first audible sound (e.g., a “click” sound) may be made by the detent 924 moving out of the second indent 928 and into the first indent 926.

[0116] When the lock 15 moves from the locked position to the unlocked position, the needle 50 may move from an unlocked condition to a locked condition, and the lock 15 may make a second audible sound (such as a “click”) with the second audible indicator 932. As the slide member 440 is moved from a locked position to an unlocked position as indicated by the arrow 810 in FIG. 14A, a second audible sound (e.g., a “click” sound) may be made by the detent 924 moving out of the first indent 926 and into the second indent 928.EXAMPLE NEEDLE LOCK HAVING TACTILE FEEDBACK

[0117] As discovered by the inventors, when locking and unlocking a needle 50 using the inventive medical injection device 100 having a nested handle 110, a user of the medical injection device 100 may desirably need to identify the operating condition of the medical injection device 100 through touch and without needing to identify the operating condition of the medical injection device 100 by visually inspecting the medical injection device 100. To provide such a desired tactile operative communication to the user of the medical injection device 100,46MEI 48657880v.1the inventors discovered that one or more tactile indicators may be included with the medical injection device 100 to indicate the operating condition of the medical injection device 100 via tactile feedback to the user. Moreover, the inventors discovered that such one or more tactile indicators may also provide additional leverage for the user in operating the medical injection device 100.

[0118] FIGS. 15A and 15B depict partial top views of an example medical injection device 100A in a locked position and an unlocked position, respectively, according to one or more embodiments described herein. The medical injection device 100A is the same as the medical injection device 100, except for the handle 110A; the handle 110A is the same as the handle 110, except for the first tubular member 10A; the first tubular member 10A is the same as the first tubular member 10, except for the distal end 12A and the lock 15 A; and the lock 15A operates in the same way as the lock 15, except for the shape of the slide member or slide 440 A. For sake of brevity, the entire medical injection device 100 A, the entire handle 110A, the entire first tubular member 10A, and the entire lock 15A are not depicted or discussed.

[0119] As with the lock 15, the lock 15 A, which is configured to prevent the needle 50 from moving and to permit the needle 50 to move, may tactilely communicate to a user of the medical injection device 100A at least two operating conditions of the lock 15A. The at least two operating conditions of the lock 15A may include a first operating condition (e.g., a locked position, a locked condition, or a locked operating condition) and a second operating condition (e.g., an unlocked position, an unlocked condition, or an unlocked operating condition). The lock 15A may include a first tactile indicator (e.g., a sharp surface 1102) and a second tactile indicator (e.g., a digit resting surface 1104) different from the first tactile indicator, and the first and second tactile indicators may correspond to the first and second operating conditions of the 47MEI 48657880v.1lock 15A, respectively (e.g., to a locked position and an unlocked position of the lock 15A, respectively).

[0120] The slide 440A of the lock 15A may include a sharp surface (e.g., a poking surface, a pyramid, a protrusion, or a pointed feature) 1102 on the proximal side of the slide 440A. When the lock 15A is in a locked position, the sharp surface 1102 is exposed, and when the lock 15A is in an unlocked position, the sharp surface 1102 is not exposed (e.g., hidden) and may be recessed in the first tubular member 10A and the lock 15 A. As the first tubular member 10A is configured to be gripped by a user, when the lock 15 A is in the locked position, the sharp surface 1102 of the slide member 440A may be positioned to be touchable by at least one of one a thumb or a finger of the user. As such, when a user operates the handle 110A, the user may determine by feeling (e.g., touching with a digit (e.g., a finger or thumb)) the sharp surface 1102 that the lock 15 A is in a locked condition and by not feeling (e.g., touching with a digit (e.g., a finger or thumb)) the sharp surface 1102 that the lock 15A is in an unlocked condition.

[0121] The slide 440A of the lock 15 A may further include a digit resting surface 1104 on the proximal side of the slide 440A. The digit resting surface 1104 may be a smooth surface or a substantially smooth surface. The digit resting surface 1104 may be a thumb rest or a finger rest. When the lock 15A is in a locked position, the digit resting surface 1104 may not be exposed (e.g., hidden) and may be recessed in the first tubular member 10A and the lock 15 A, and when the lock 15 A is in an unlocked position, the digit resting surface 1104 may be exposed. As the first tubular member 10A is configured to be gripped by a user, when the lock 15A is in the unlocked position, the digit resting surface 1104 of the slide member 440A may be positioned to be touchable by at least one of one a thumb or a finger of the user. As such, when a user operates the handle 110A, the user may determine by not feeling (e.g., touching with a digit (e.g.,48MEI 48657880v.1a finger or thumb)) the digit resting surface 1104 that the lock 15 A is in an locked condition and by feeling (e.g., touching with a digit (e.g., a finger or thumb)) the digit resting surface 1104 that the lock 15 A is in an unlocked condition. Moreover, the digit resting surface 1104 may provide additional surface for the user to apply pressure in a direction 1110 when inserting the needle 50 into a tumor. For example, the user’s thumb may rest on the digit resting surface 1104 when applying pressure in the direction 1110.

[0122] When the lock 15A is in the locked position, the needle 50 may be in a locked position and prevented from moving, the sharp surface 1102 of the lock 15 A may be exposed, and the digit resting surface 1104 of the lock 15 A may not be exposed. When the lock 15 A is in the unlocked position, the needle 50 may be in an unlocked position and permitted to move, the sharp surface 1102 of the lock 15 A may not be exposed, and the digit resting surface 1104 of the lock 15A is exposed.

[0123] The slide member 440A of the lock 15 A may include the sharp surface 1102 and the digit resting surface 1104. As the first tubular member 10A is configured to be gripped by a user, when the lock 15A is in the locked position, the sharp surface 1102 of the slide member 440A may be positioned to be touchable by at least one of one a thumb or a finger of a user, and when the lock 15 A is in the unlocked position, the digit resting surface 1104 of the slide member 440A may be positioned to be touchable by at least one of one a thumb or a finger of a user. When the lock 15A is in the locked position, the slide member 440A may protrude from a first side of the first tubular member 10A by a first distance DI, and when the lock 15A is in the unlocked position, the slide member 440A may protrude from a second side of the first tubular member 10A opposite the first side by the same first distance DI. For example, the first distance DI may be at least 0.5 to at most 3.0 cm.49MEI 48657880v.1

[0124] The distal end 12A of the first tubular member 10A may include a digit resting surface 1106. The digit resting surface 1106 may be a smooth surface or a substantially smooth surface. The digit resting surface 1106 may be a thumb rest or a finger rest. When the lock 15A is in the unlocked position, the slide member 440A may protrude from the digit resting surface 1106.

[0125] When viewed from a direction perpendicular to the top side 115 of the handle 110A, the distal end 12A of the first tubular member 10A may be asymmetrical about a longitudinal axis 1115 for the proximal end 111 to the distal end 112. When viewed from a direction perpendicular to the top side 115 of the handle 110A, the distal end 12A of the first tubular member 10A may include an asymmetrical protrusion 1108. As discussed previously, to assist 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. However, for the distal end 12A of the first tubular member 10A, the asymmetrical protrusion 1108 may be protruding from the cylindrical convex shape 1118. For example, when viewed from a direction perpendicular to the top side 115 of the handle 110A, a furthermost point of the cylindrical convex shape 1118 may extend a second distance D2 from an innermost point of the cylindrical concave shape 1116. For example, the second distance D2 may be at least 0.5 to at most 3.0 cm. For example, when viewed from a direction perpendicular to the top side 115 of the handle 110A, a furthermost point of the asymmetrical protrusion 1108 may extend a third distance D3 from an innermost point of the cylindrical concave shape 1116. For example, the third distance D3 may be at least 1.0 to at most 3.0 cm.

[0126] The asymmetrical protrusion 1108 may include the digit resting surface 1106 on a proximal side of the asymmetrical protrusion 1108. As depicted in FIG. 15B, when the lock 15A 50MEI 48657880v.1is in the unlocked position, the slide member 440A and the digit resting surface 1104 of the slide member 440A may protrude from the asymmetrical protrusion 1108 of the first tubular member 10A. In use, when the lock 15A is in the unlocked position, the digit resting surface 1106 and the digit resting surface 1104 may provide surface for the user to apply pressure in the direction 1110 when inserting the needle 50 into a tumor. For example, the user’s thumb may rest on the digit resting surface 1106 and the digit resting surface 1104 when applying pressure in the direction 1110.

[0127] FIG. 16 depicts an exterior top view of an example medical injection device 400 with a lock 415 according to one or more embodiments described herein. The injection device 400 may include features from injection device 100. For example, the injection device 400 may have a plurality of tubular members including a first tubular member 10 with a viewing window 13 and a second tubular member 20, where indicia 24 of the second tubular member 20 may be viewable by a user through the viewing window 13. The first tubular member 10 and second tubular member 10 may be user operable to move independently of each other. Additionally, the first tubular member 10 and second tubular member 20 may be user operable to independently extend and retract the needle 50 and the sheath 40 from the working channel. In an embodiment, the needle 50 may be connected to an interior of the first tubular member 10, as described herein.

[0128] The lock 415 may be integrated into or part of the first tubular member 10. The lock 415 may be biased into a locked state. The first tubular member 10 may include lock 415 to lock and unlock the first tubular member 10 with respect to the second tubular member 20. In an embodiment, the second tubular member 20 may be nested in the first tubular member 10. The lock 415 may be user operable by needle lock control 4151 to actuate the lock 415 between a locked state and an unlocked state. The needle lock control 4151 may include two needle lock 51MEI 48657880v.1side controls 4151 A, 4151B disposed on opposing sides of the first tubular member 10. In some embodiments, the needle lock control 4151 may include a single needle lock side control. While in the locked state, the lock 415 may prevent inadvertent extension of the needle 50 from the sheath 40.

[0129] FIGS. 17A and 17B depict cross-sectional views of an example medical injection device 400 with a lock 415 in a locked state according to one or more embodiments described herein. In an embodiment, lock 415 may include at least one first body 4152 disposed on an interior of the first tubular member 10. The at least one first body 4152 may be configured to engage at least one second body 4153 of the second tubular member 20. The at least one first body 4152 may include a plurality of recesses extending along a length of an interior wall of the first tubular member 10, as shown in FIGS. 17A and 17B. The plurality of recesses may have a triangular shape, however, the plurality of recesses may be any suitable shape capable of engaging at least one second body 4153. The at least one second body 4153 may be disposed on a proximal end 21 of the second tubular member 20. The at least one second body 4153 may include at least one protrusion extending from the proximal end 21 of the second tubular member 20. The protrusions may have a triangular shape, however, the protrusion may be any suitable shape capable of engaging the plurality of recesses. The plurality of recesses may be configured to receive and engage the protrusions to fix the first tubular member 10 and the second tubular member 20 to one another to prevent translation of each of the first tubular member 10 and the second tubular member 20 relative to one another. Each protrusion may be configured to maintain engagement with at least one recess of the at least one first body 4152 while the lock 415 is in a locked state.52MEI 48657880v.1

[0130] In an alternative embodiment, the at least one first body 4152 may include a plurality of protrusions extending along a length of an interior wall of the first tubular member 10.Further, the at least one second body 4153 may include at least one recess formed into the proximal end 21 of the second tubular member 20. The at least one recess may be configured to receive and engage at least one of the protrusions to fix the first tubular member 10 and the second tubular member 20 to one another to prevent translation of each of the first tubular member 10 and the second tubular member 20 relative to one another. Each protrusion may be configured to maintain engagement with at least one recess of the at least one first body 4152 while the lock 415 is in a locked state.

[0131] The lock 415 may include a biasing member 4154 configured to bias the lock 415 and needle lock control 4151 into the locked state. In a locked state, the biasing member 4154 may exert an outward force against the at least one second body 4153 and the proximal end 21 of the second tubular member 20 such that the at least one second body 4153 are biased into engagement with at least one first body 4152 and the second tubular member 20 and sheath 40 are locked relative to the first tubular member 10 and needle 50, respectively. The biasing member 4154 may be configured to bias the lock 415 into a locked state. The biasing member 4154 may be any suitable biasing member that biases the lock 415 into a locked state. For instance, in one example, the biasing member 4154 can be a substantially U-shaped body positioned between opposing sides of the distal end 21 of the second tubular member 20.Referring to FIG. 17B, the biasing member 4154 may be coupled to the distal end 21 of the second tubular member 20 by a coupling structure 4155 engaged with an aperture formed adjacent to each end of the U-shaped biasing member 4154.53MEI 48657880v.1

[0132] Further, each end of the biasing member 4154 may be positioned such that when the needle lock side controls 4151 A, 4151B are radially depressed, the ends of the biasing member 4154 are pushed towards each other. Additionally, since the biasing member 4154 is coupled to the proximal end 21 of the second tubular member 20, the at least one second body 4153 may be disengaged from the at least one first body 4152, and the lock 415 may be adjusted into an unlocked state. While in the unlocked state, the needle lock side controls 4151 A, 4151B may be allowed to move within a lock control channel 4156, which may have an opening on opposing sides of the first tubular member 10 to accommodate the needle lock side controls 4151 A, 4151B. Further, movement of the needle lock control 4151 may be translated such that movement of the needle lock side controls 4151 A, 415 IB may be used for movement of second tubular member 20 and sheath 40 relative to the first tubular member 10 and needle 50, respectively. For example, the needle lock side controls 4151A, 4151B may be configured to move within a lock control channel 4156 to permit the needle to extend and retract from the sheath when in the unlocked state.

[0133] In an alternative embodiment, at least one first body 4152 may comprise a first friction member disposed on an interior of the tubular member 10. The first friction member may extend along a length of an interior wall of the first tubular member 10. The first friction member may be configured to engage at least one second body 4153, which may comprise a second friction member. The second friction member may be disposed on a proximal end 21 of the second tubular member 20. The second friction member may be configured to engage the first friction member while the lock 415 is in a locked state. In some embodiments, the first friction member may include at least one of a rough surface, a soft elastomer, and a tooth style protrusion to frictionally engage with a corresponding rough surface of the second friction 54MEI 48657880v.1member. The first friction member and second friction members may be an alternative to the protrusions and recesses described above to fix the first tubular member 10 and the second tubular member 20 to one another to prevent translation of each of the first tubular member 10 and the second tubular member 20 relative to one another.

[0134] The lock 415 may include a biasing member, similar to biasing member 4154, configured to bias the lock 415 and needle lock control 4151 into the locked state. In a locked state, the biasing member may exert an outward force against second friction member and the proximal end 21 of the second tubular member 20 such that the second friction member is biased into engagement with the first friction member and the second tubular member 20 and sheath 40 are locked relative to the first tubular member 10 and needle 50, respectively.

[0135] Further, each end of the biasing member may be positioned such that when the needle lock control 4151 is radially depressed, the ends of the biasing member are pushed towards each other. Additionally, since the biasing member is coupled to the proximal end 21 of the second tubular member 20, second friction member may be disengaged from first friction member and the lock 415 is adjusted into an unlocked state. While the lock 415 is in the unlocked state, the needle lock control 4151 may be allowed to move axially along a length of a tubular member. Further, movement of the needle lock control 4151 may be translated such that movement of the needle lock control 4151 may be used for movement of second tubular member 20 and sheath 40 relative to the first tubular member 10 and needle 50, respectively. Additionally, the needle lock control 4151 may be allowed to move axially within a lock control channel 4156. The lock control channel 4156 may be used allow movement of second tubular member 20 and sheath 40 relative to the first tubular member 10 and needle 50, respectively, within a specified range.55MEI 48657880v.1Further, the needle lock control 4151 may be configured to move within a lock control channel 4156 to permit the needle to extend and retract from the sheath when in the unlocked state.

[0136] FIG. 18 depicts a cross-sectional view of a portion of an alternative example medical injection device 600 with a needle lock 615 having translation supports 6157 according to one or more embodiments described herein. The injection device 600 may include features from any of injection devices 100, 400. Additionally, the lock 615 may include features from lock 415, and the needle lock control 6151 may include features of the needle lock control 4151. The needle lock control 6151 may be biased into a locked state by a biasing member and may, additionally, be depressed radially to disengage at least one second body, such as second body 4153, from the at least one first body, such as first body 4152 and adjust the needle lock 615 into an unlocked state, similar to the needle lock control 4151. Accordingly, when the needle lock control 6151 is depressed and the lock 615 is in the unlocked state, needle lock control 6151 and tubular member 20 may be allowed to move relative to tubular member 10 since the at least one second body and the at least one first body are disengaged. Further, movement of the needle lock control 6151 may be translated such that movement of the needle lock side controls 6151 A, 6151B may be used for movement of second tubular member 20 and sheath 40 relative to the first tubular member 10 and needle 50, respectively. For example, the needle lock side controls 6151A, 615 IB may be configured to move to permit the needle to extend and retract from the sheath when lock 615 is in the unlocked state. Additionally, needle lock control 6151 may include a translation support 6157A, 6157B (collectively 6157). A user may use translation supports 6157 to support movement of the needle lock control 6151 and allow for easier movement of the needle lock control 6151 for movement of second tubular member 20 and sheath 40 relative to the first tubular member 10 and needle 50, respectively. For example, in an embodiment, each 56MEI 48657880v.1needle lock side control 6151 A, 6151B of the needle lock control 6151 may comprise a translation support 6157A, 6157B. The translation supports 6157 may be coupled to, formed integrally with, and the like with needle lock control 6151.EXAMPLE INJECTION LOCKOUT

[0137] As discovered by the inventors, when locking and unlocking a needle 50 using the inventive medical injection device 100 having a nested handle 110, a user of the medical injection device 100 may desire to prevent injection of the medical substance unless the needle 50 is in a locked condition. To provide such a desired injection lockout, the inventors discovered that the medical injection device 100 may be in communication with one or more devices responsible for injection of the medical substance (e.g., referring to FIG. 22, such devices may include a pump 1520 and / or a computer 1560). The medical injection device 100 may send one or more signals to one or more of these devices that indicate when the needle 50 is in a locked operating condition and optionally when the needle 50 is in an unlocked operating condition. Until such a device(s) receives a signal indicating a locked operating condition for the needle 50, the device(s) may lockout injection of the medical substance, and after such a device(s) receives a signal indicating a locked operating condition for the needle 50, the device(s) may permit injection of the medical substance. Moreover, such device(s) may provide feedback (e.g., visual and / or audio information) to the user indicating an injection lockout condition and / or an injection permitted condition.

[0138] FIGS. 19A and 19B depict partial cross-section side views of an example medical injection device 100B in a locked position and an unlocked position, respectively, according to one or more embodiments described herein. FIGS. 20A and 20B depict partial cross-section side 57MEI 48657880v.1views of an example medical injection device 100B in a locked position and an unlocked position, respectively, according to one or more embodiments described herein. The medical injection device 100B is the same as the medical injection device 100, except for the handle HOB; the handle 11 OB is the same as the handle 110, except for the first tubular member 10B and the second tubular member 20B; the first tubular member 10B and the second tubular member 20B are the same as the first tubular member 10 and the second tubular member 20, respectively, except for the lock 15B and the teeth 450B; and the lock 15B operates in the same way as the lock 15 to lock the needle 50, except for the slide member 440B and the ability to make an electrical connection by operation of the lock 15B. For sake of brevity, the entire medical injection device 100B, the entire handle HOB, the entire first tubular member 10B, and the entire lock 15B are not depicted or discussed.

[0139] As with the lock 15, the lock 15B, which is configured to prevent the needle 50 from moving and to permit the needle 50 to move, may communicate operating conditions of the lock 15B to a computer apparatus (e.g., processor-based device(s) used in the process of injecting medical substance to a subject (e.g., the computer 1560 and / or the pump 1520)). The communicated operating conditions may include operating conditions of the lock 15B, and the operating conditions of the lock 15B may include a first operating condition (e.g., a locked position, a locked condition, or a locked operating condition) and a second operating condition (e.g., an unlocked position, an unlocked condition, or an unlocked operating condition).

[0140] The lock 15B may be attached to the first tubular member 10B and may include a first portion (or first electrical contact portion, or first electrical connection surface) 1202 configured to engage with and make an electrical connection with a second portion (or second electrical contact portion, or second electrical connection surface) 1204 of the second tubular member 58MEI 48657880v.120B. The lock 15B may include the slide member 440B attached to the first tubular member 10B, where the slide member 440B may include the first portion 1202. The second tubular member 20B may include the plurality of teeth 450B, where the plurality of teeth 450B may include the second portion 1204. The slide member 440B having the first portion 1202 may be configured to engage with and make an electrical connection with the second portion 1204 of the teeth 450B. In some embodiments, the first portion 1202 may be metal, have metal surfaces, have metal overlay, or have metal coating; the second portion 1204 may be metal, have metal surfaces, have metal overlay, and / or have metal coating; and the first portion 1202 and the second portion 1204 may make an electrical connection when the first portion 1202 and the second portion 1204 touch, abut, connect, or contact. The slide member 440B may have different electrical connections with the teeth 450B based on the operating condition of the slide member 440B. For example, in a locked operating condition, the slide member 440B and the teeth 450B may make a closed circuit, and in an unlocked operating condition, the slide member 440B and the teeth 450B may make an open circuit.

[0141] In some embodiments, at least one groove 1206 in the plurality of teeth 450B does not include the second portion 1204. The at least one groove 1206 may be at an end of a row of the plurality of teeth 450B (such as depicted in FIGS. 19A and 19B). A groove 1206 may be defined by two teeth sides in the plurality of teeth 450B, where the two teeth sides may be one tooth and an end portion shaped as a tooth side (such as depicted in FIGS. 19A and 19B) or where the two teeth sides may be parts of two consecutive teeth.

[0142] The lock 15B may have at least two operating conditions. In a first operating condition (e.g., a locked operating condition), the lock 15B is in a locked position, the needle 50 is in a locked position and prevented from moving (e.g., prevented from being extended and 59MEI 48657880v.1retracted from the distal end 42 of the sheath 40), the slide member 440B may be electrically connected to the teeth 450B, and the lock 15B may be configured to communicate to the computer apparatus a first signal corresponding the first operating condition of the lock 15B. For the first operating condition, when the lock 15B is in a locked position, the handle 11 OB may be configured to provide a locked signal to the computer apparatus, and the computer apparatus may permit the injection substance to be pumped to the handle HOB. For example, the computer 1560 may permit the pump 1520 to pump the injection substance. When the lock 15B is in the locked position, the first tubular member 10B and the second tubular member 20B may be locked together and prevented from moving independently of each other. When the lock 15B is in the locked position, the third tubular member 30 is not locked together with the first tubular member 10B and the second tubular member 20B. For the first operating condition, when the lock 15B is in the locked position and further when the handle 11 OB is not in the fully extended position, the handle 11 OB may be configured to provide the locked signal to the computer apparatus.

[0143] In a second operating condition (e.g., an unlocked operating condition), the lock 15B may be in an unlocked position, the needle 50 may be in an unlocked position and permitted to move (e.g., permitted to be extended and retracted from the distal end 42 of the sheath 40), the slide member 440B may not be electrically connected to the teeth 450B, and the lock 15B may be configured to communicate to the computer apparatus a second signal corresponding the second operating condition of the lock 15B. For the second operating condition, when the lock 15B is in an unlocked position, the handle HOB may be configured to provide an unlocked signal to the computer apparatus, and the computer apparatus may prevent or not permit the injection substance to be pumped to the handle HOB. For example, the computer 1560 may 60MEI 48657880v.1lockout the pump 1520 from pumping the injection substance. When the lock 15B is in the unlocked position, the first tubular member 1 OB and the second tubular member 20B are unlocked from each other and permitted to move independently of each other. When the lock 15B is in the unlocked position, the third tubular member 30 may not be locked together with the first tubular member 10B and the second tubular member 20B.

[0144] In addition the first and second operating conditions, the lock 15B may have a third operating condition. In the third operating condition (e.g., a locked operating condition), the lock 15B is in a locked position, the slide member 440B is not electrically connected to the teeth, and the handle 100B is in a fully extended position. For the third operating condition, when the lock 15B is in the locked position and further when the handle 11 OB is in a fully extended position, the handle 11 OB may be configured to provide the unlocked signal to the computer apparatus, and the computer apparatus may prevent or not permit the injection substance to be pumped to the handle 11 OB. For example, the computer 1560 may lockout the pump 1520 from pumping the injection substance. When the handle 110B is being transported and initially connected to the injection system, the handle HOB may be in the locked position of the third operation condition, and the handle HOB may be in the fully extended position with the needle 50 is in the sheath 60 and not extended from the sheath 60. Such a third operating condition may be beneficial to prevent injection of injection substance until the needle 50 has been placed in position.In some embodiments, the computer apparatus may be the computer 1560, which may configured to be in communication with both the handle HOB and an injection system to provide the injection substance supply (e.g., the pump 1520). When the computer apparatus receives a signal from the handle 110B indicating the lock 15B is in an unlocked position, the computer 61MEI 48657880v.1apparatus may be configured to prevent the injection system from providing the injection substance to the handle 11 OB and optionally may be configured to provide a visual indicator (e.g., one or more words, phrases (e.g., “NEEDLE UNLOCKED”), icons, images, etc.) for a user indicating the injection system is prevented from providing the injection substance supply to the handle HOB. The visual indicator may be displayed on a display of the computer apparatus. When the computer apparatus receives a signal from the handle HOB indicating the lock 15B is in a locked position, the computer apparatus may be configured to permit the injection system to provide the injection substance to the handle HOB and optionally may be configured to provide a visual indicator (e.g., one or more words, phrases (e.g., “NEEDLE LOCKED”), icons, images, etc.) for a user indicating the injection system is permitted to provide the injection substance supply to the handle HOB. The visual indicator may be displayed on a display of the computer apparatus.EXAMPLE FASTENER

[0145] As discovered by the inventors, when attaching the inventive medical injection device 100 having a nested handle 110 to a working channel (and / or a medical procedure device having a working channel), a user of the medical injection device 100 may desirably need to know the operating condition of the medical injection device 100 once the inventive medical injection device 100 is attached to the working channel or instrumentation attached to the working channel. To provide such a desired operative communication to the user of the medical injection device 100, the inventors discovered that the medical injection device 100 may be desirably rotated so that visual indicators on the handle 100 (e.g., referring to FIG. 1, indicia 24, viewing window 13, indicia 34, and / or viewing window 23) may be rotated and then locked into the 62MEI 48657880v.1user’s view. In use, the medical injection device 100 may first be attached to (or engaged with) but not secured (or locked) to the working channel (e.g., the medical injection device 100 and the working channel may be translatably fixed relative to one another along the longitudinal direction but not rotationally fixed relative to one another), then rotated so that visual indicators on the handle 100 are in the user’s view, and then secured (or locked) onto the working channel (e.g., the medical injection device 100 and the working channel may be rotationally fixed relative to one another) preventing the medical injection device 100 from further rotation with respect to the working channel, thereby locking the visual indicators on the handle 100 into the user’s view.

[0146] FIG. 21 A depicts a partial exterior perspective view of the distal portion of the example medical injection device 100 according to one or more embodiments described herein. FIG. 21B depicts a partial interior cross-section view along line 21B-21B’ in FIG. 21 A of the example medical injection device 100 according to one or more embodiments described herein. FIG. 21 C depicts a enlarged partial interior cross-section view of portion 21C in FIG. 2 IB of the example medical injection device 100 according to one or more embodiments described herein.

[0147] The fastener 35 at the distal end 112 of the handle 110 and at the distal end 32 of the third tubular member 30 may have a proximal end 351 and a distal end 352. The fastener 35 may be configured to secure the handle 110 to a working channel and to permit the handle 110 to rotate until the handle 110 is secured to the working channel. The handle 110 and the fastener 35 may be configured to be rotated independently of each other about a central longitudinal axis 1442 of the handle 110. The third tubular member 30 and the fastener 35 may be configured to be rotated independently of each other about a central longitudinal axis 1442 of the third tubular member 30. When the fastener 35 engages but not secures the handle 110 to the working channel (e.g., the fastener 35 and the working channel are translatably fixed relative to one 63MEI 48657880v.1another along the longitudinal direction but not rotationally fixed relative to one another), the handle 110 may be rotatable about the central longitudinal axis 1442 of the handle 110 with respect to the working channel. When the fastener 35 engages and secures the handle 110 to the working channel (e.g., the fastener 35 and the working channel are rotationally fixed relative to one another), the handle 110 may be prevented from rotating about the central longitudinal axis 1442 of the handle 110 with respect to the working channel. When the fastener 35 is engaged but not secured to the working channel, the fastener 35 may be freely rotatable about the handle 110.

[0148] Prior to the fastener 35 securing (or locking) the handle 110 to the working channel, the handle may be rotatable about the central longitudinal axis 1442 of the handle 110 with respect to the working channel. Prior to the fastener 35 securing the handle 110 to the working channel, at least one viewing window 13, 23 and / or indicia 24, 34 may be rotatable about the central longitudinal axis 1442 of the handle 10 with respect to the working channel to a user desired position. For example, prior to the fastener 35 securing the medical injection device 100 to the working channel, the viewing window 13, 23 may be rotatable about the central longitudinal axis of 1442 of the second tubular member 20 with respect to the working channel to a user desired position.

[0149] The fastener 35 may include a rotatable collar 1450. The collar 1450 may have a proximal end 1451 and a distal end 1452. The collar 1450 may include exterior surface features 1454, such as (without limitation) ribs or knurls, configured to be gripped by a user for ease in rotation of the collar 1450. The collar 1450 may include interior threads 1476 on an interior side of interior body 1470 of the collar 1450, and the interior threads 1476 may be configured to engage external threads disposed on the working channel or instrumentation attached to the 64MEI 48657880v.1working channel. When the interior threads 1476 are engaged and not tightened to the external threads of the working channel or instrumentation, the handle 110 may be rotatable about the central longitudinal axis 1442 of the handle 110 with respect to the working channel, and when the collar 1450 is secured in this manner to the external threads of the working channel or instrumentation, the handle 110 may be rotated so that indicia on the handle are in the user’s view. When the interior threads 1476 are engaged and tightened to the working channel or instrumentation, the handle 110 may be unable to rotate about the central longitudinal axis 1442 of the handle 110 with respect to the working channel or instrumentation.

[0150] The collar 1450 may include an exterior body 1460 and an interior body 1470. The exterior body 1460 may have a proximal end 1461 and a distal end 1462, and the interior body 1470 may have a proximal end 1471 and a distal end 1472. The distal end 1462 of the exterior body 1460 and the distal end 1472 of the interior body 1471 of the collar 1450 may form (or define) the distal end 1452 of the collar 1450, which may form (or define) the distal end 352 of the fastener 35. The proximal end 1461 of the exterior body 1460 of the collar 1450 may form (or define) the proximal end 351 of the fastener 35. The proximal end 1471 of the interior body 1470 of the collar 1450 may be located axially in the direction of the central longitudinal axis 1442 between the proximal end 1461 of the exterior body 1460 and the distal end 352 of the fastener 35.

[0151] The exterior body 1460 and the interior body 1470 may be welded together in at least one location. The exterior body 1460 and the interior body 1470 may be welded together at the distal end 352 of the fastener 35. As depicted in FIG. 21 C, the exterior body 1460 and the interior body 1470 may be welded together at a first friction weld joint 1481 and a second65MEI 48657880v.1friction weld joint 1482. In some embodiments, exterior body 1460 and the interior body 1470 may be formed as a unitary body.

[0152] The fastener 35 may be connected to the third tubular member 30. The third tubular member 30 may include an exterior body 1410 and an interior body (or interior central body) 1430 shrouded by the exterior body 1410. The exterior body 1410 may include a proximal end 1411 and a distal end 1412, and the interior body 1430 may include a proximal end 1431 and a distal end 1432. The distal end 1412 of the exterior body 1410 may be located along the longitudinal axis 1442 of the handle 110 between the proximal end 1431 and the distal end 1432 of the interior body 1430. The proximal end 1431 of the interior body 1430 may be located along the longitudinal axis 1442 of the handle 110 between the proximal end 1411 and the distal end 1412 of the exterior body 1410.

[0153] The sheath 40 may be located axially along the longitudinal axis 1442 within the interior body of the third tubular member 30. The sheath 40 may be configured to move axially through the interior body 1430 of the third tubular member 30. The sheath 40 may be connected to the second tubular member 20, the third tubular member 30 may be nested in the second tubular member 30, and axial movement of the second tubular member 20 along the longitudinal axis 1442 axially moves the sheath 40 through the interior body 1430 of the third tubular member 30.

[0154] The exterior body 1410 and interior body 1430 may have keyed shapes that engage one another to prevent the exterior body 1410 and the interior body 1430 from rotating about the longitudinal axis 1442 relative to one another. The keyed shapes can have non-circular crosssections that engage one another to prevent relative rotation. In some examples, the exterior body 1410 can have a shape with at least one flat portion that engages with at least one flat portion of 66MEI 48657880v.1the interior body 1430. As depicted in FIG. 21B, the exterior body 1410 may include a first flat portion 1414 and a second flat portion 1415. The first flat portion 1414 and the second flat portion 1415 may be located between the proximal end 1411 and the distal end 1412 of the exterior body 1410 and may be located on opposite side of the exterior body 1410. As depicted in FIG. 21B, the interior body 1430 may include a first flat portion 1434 and a second flat portion 1435. The first flat portion 1434 and the second flat portion 1435 may be located at the proximal end 1431 of the interior body 1430 and may be located on opposite side of the interior body 1430. To prevent the exterior body 1410 and the interior body 1430 from rotating about the longitudinal axis 1442, the first flat portion 1414 of the exterior body 1410 may abut or engage with the first flat portion 1434 of the interior body 1430 in the flat area (or planar area) 1417. To prevent the exterior body 1410 and the interior body 1430 from rotating about the longitudinal axis 1442, the second flat portion 1415 of the exterior body 1410 may abut or engage with the second flat portion 1435 of the interior body 1430 in a flat area (or planar area) similar to flat area 1417.

[0155] The distal end 1432 of the interior body 1430 of the third tubular member 30 may be tapered to press fit with the working channel or instrumentation. The distal end 32 of the third tubular member 30 may be tapered to press fit with the working channel or instrumentation. The fastener 35 may be rotatable about the third tubular member 30 at the distal end 32 of the third tubular member 30.

[0156] The collar 1450 of the fastener 35 may include at least one support ridge or surface configured to engage the third tubular member 30 when the working channel is attached to the medical injection device 100. The collar 1450 may include a first support ridge or surface (or first tension support ridge or surface) 1464 configured to engage a first engagement portion 141667MEI 48657880v.1of the exterior body 1410 of the third tubular member 30 when the working channel is attached to the medical injection device 100. The collar 1450 may include a second support ridge or surface (or second tension support ridge or surface) 1474 configured to engage a second engagement portion 1436 of the interior body 1430 of the third tubular member 30 when the working channel is attached to the medical injection device 100. The first support ridge 1464 and the second support ridge 1474 may aid in the tapered distal end 1440 of interior body 1430 to be press fit with the working channel in the direction 1444. The first support ridge 1464 of the exterior body 1410 of the third tubular member 30 and the second support ridge 1474 of the interior body 1430 of the third tubular member 30 may prevent the exterior body 1410 and the interior body 1430 translating relative to one another. For instance, the support ridges 1464, 1475 may prevent the bodies 1410, 1430 from translating relative to one another, and the flat surfaces 1414, 1434, 1415, and 1435 may prevent the bodies 1410, 1430 from rotating relative to one another.EXAMPLE ENVIRONMENT FOR MEDICAL INJECTION

[0157] FIG. 22 depicts an example environment for using the example medical injection device 100 according to one or more embodiments described herein. In FIG. 22, the medical injection device 100 is a depicted being used with a working channel 1510 that comprises a non-robotic bronchoscope 1515. The medical injection device 100 is connected to the working channel 1510 to treat a tumor 1540 in the lung of the subject. At the distal end 1511 of the working channel 1510, the sheath 40 is extended from the working channel 1510 by user operation of the handle 110, and the needle 50 is extended from the sheath 50 by user operation of the handle 110. The pump 1520 dispenses the medical substance 1550, which travels through 68MEI 48657880v.1tubing and connectors, through a pressure sensor and data logger 1530, through the medical injection device 100, and through the needle 40 and injected into the tumor 1540 as injected medical substance 1550.

[0158] In FIG. 22, a computer 1560 may be used in an example environment to provide information and / or feedback to the user and may be electrically and / or signally connected to other devices in the example environment via one more connections 1562, which may wired (e.g., electrical and / or optical) and / or wireless. In some embodiments, the computer 1560 may be connected to the medical injection device 100, and based on information received from the medical injection device 100, the computer 1560 may control one or more devices in the example environment. For example, as discussed with respect to FIGS. 19A, 19B, 20A, and 20B, if the medical injection device 100 is not in a desired operating condition (e.g., the needle 50 is not in a locked position and / or is in an unlocked position), the medical injection device 100 may transmit information to the computer 1560 as to this operating condition, and the computer 1560 may act on this information (e.g., the computer 1560 may prevent the pump 1520 from operating and injecting the medical substance 1550 and / or may provide feedback on the operating condition to the user via a display or a speaker of the computer 1560).

[0159] While FIG. 22 depicts the medical injection device 100 being used with a non-robotic bronchoscope, the medical injection device 100 may readily be used in other environments, such as, for example, with a robotic bronchoscope, with an endobronchial ultrasound (EBUS), or in a percutaneous procedure.EXAMPLE COMPUTER APPARATUS69MEI 48657880v.1

[0160] FIG. 23 depicts an example computer apparatus 1600 for use with one or more embodiments described herein. As an example, the computer apparatus 1600 may be a computer to implement certain inventive techniques disclosed herein. In some examples, computer apparatus 1600 can be used to implement the computer 1560. As an example, some of the steps in the method illustrated in FIGS. 24, 25, 26 and 27 may be performed using a computer apparatus 1600.

[0161] The apparatus 1600 may include one or more processors 1602, memory 1603, one or more input devices 1605, and one or more output devices 1606.

[0162] Input to the apparatus 1600 may be provided by one or more input devices 1605, provided from one or more input devices in communication with the apparatus 1600 via link 1601 (e.g., a wired link or a wireless link; e.g., with a direct connection or over a network), and / or provided from another computer(s) in communication with the apparatus 1600 via link 1601.

[0163] Output for the apparatus 1600 may be provided by one or more output devices 1606, provided to one or more output devices in communication with the apparatus 1600 via link 1601, and / or provided from another computer(s) in communication with the apparatus 1600 via link 1601. The one or more output devices 1606 may include one more displays and one or more speakers. The output device(s) 1606 may display visual indicators according to one or more embodiments described herein.

[0164] In some embodiments, one or more input devices 1605 and one or more output devices 1606 may be combined into one or more unitary input / output devices (e.g., a touch screen).70MEI 48657880v.1

[0165] In some embodiments, based on input from one or more input devices 1605 or input from outside the apparatus 1600 via the link 1601, the one or more processors 1602 may perform operations as described herein. As an example, user input may be received from the one or more input devices 1605. As an example, input may be from another computer in communication with the apparatus 1600 via link 1601. As an example, input may be from one or more input devices in communication with the apparatus 1600 via link 1601.

[0166] In some embodiments, the one or more processors 1602 may perform operations as described herein and provide results of the operations as output. As an example, output may be provided to the one or more output devices 1606. As an example, output may be provided to another computer in communication with the apparatus 1600 via link 1601. As an example, output may be provided to one or more output devices in communication with the apparatus 1600 via link 1601.

[0167] The memory 1603 may be accessible by the one or more processors 1602 so that the one or more processors 1602 may read information from and write information to the memory 1603. The memory 1603 may store instructions that, when executed by the one or more processors 1602, implement one or more embodiments described herein. The memory 1603 may be a non-transitory computer readable medium (or a non-transitory processor readable medium) containing a set of instructions thereon, wherein when executed by a processor (such as one or more processors 1602), the instructions cause the processor to perform one or more methods discussed herein.

[0168] The apparatus 1600 may include: one or more processors (such as one or more processors 1602); and memory (such as memory 1603) accessible by the one or more processors,71MEI 48657880v.1the memory storing instructions that when executed by the one or more processors, cause the apparatus to perform one or more methods described herein.

[0169] The memory 1603 may be a non-transitory processor readable medium containing a set of instructions thereon, wherein when executed by one or more processors (such as one or more processors 1602), the instructions cause the one or more processors to perform one or more methods described herein.EXAMPLE FLOWCHART FOR MEDICAL INJECTION

[0170] FIG. 24 depicts an example flowchart for a method 1700 for medical injection of using the example injection device 100 according to one or more embodiments described herein. In some embodiments, steps 1722, 1726, and 1728 of the method of FIG. 24 may be computer-implemented steps or have aspects that are computer-implemented. Such steps of the method of FIG. 24 may be implemented using any suitable system or apparatus, such as the apparatus 1600 of FIG. 23. As an example, the computer 1560 be implemented by an apparatus 1600. While an order of operations is indicated in FIG. 24 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.

[0171] In step 1702, the injection supply system may be attached to the distal end 111 of the handle 110. For this example, the injection substance is a fluid.

[0172] In step 1704, the needle 50 and the injection supply system may be primed with a fluid to inject into the subject.

[0173] In step 1706, the handle 100 may be in a fully open and extended position, as in FIGS. 1, 2A, and 2B. The first tubular member 10 may be locked in position with respect to the 72MEI 48657880v.1second tubular member 20, and as such, the needle 50 may be locked in a retracted position. The lock 15 may be in a locked position. The first tubular member 10 may be secured to the second tubular member 20. The second tubular member 20 may be locked in position with respect to the third tubular member 30, and as such, the sheath 40 may be locked in a retracted position. The lock 25 may be in a locked position. The second tubular member 20 may be secured to the third tubular member 30.

[0174] In step 1708, the working channel (e.g., a scope working channel, an extended working channel, a robot working channel) may be inserted into the subject.

[0175] In step 1710, the sheath 40 and the needle 50 may be inserted into the working channel. The needle 50 may be shrouded by the sheath 40.

[0176] In step 1712, the handle 110 may be attached to the working channel, rotated to a desired position to view indicia on the handle 110, and locked to the working channel using the fastener 35. The handle 110 may be connected to the sheath 40 and the needle 50. The handle 110 may be releasably locked to the working channel using the fastener 35. Prior to releasably locking the handle 110 to the working channel, the handle 110 may be engaged with but locked to the working channel using the fastener 35, the handle 110 may be rotated with respect to the working channel to a user desired position (e.g., so the user can see indicia on the handle 110), and then the handle 110 may be locked to the working channel using the fastener 35. At this point, the distal end 42 of the sheath 40 may be located at the distal end of the working channel and near the opening at the distal end of the working channel.

[0177] In step 1714, the second tubular member 20 may be unlocked from the third tubular member 30 using the lock 25. The lock 25 may be in a unlocked position.73MEI 48657880v.1

[0178] In step 1716, the second tubular member 20 may be slid or moved along the third tubular member 30 to extend the sheath 40 from the distal end of the working channel, out from the opening at the distal end of the working channel, and into the subject. The user may operate the second tubular member 20 to extend the sheath 40 from the distal end of the working channel. The sheath 40 may be extended to a desired position in the subject. The user may determine how far the sheath 40 is extended by viewing the viewing the indicia 34 through the viewing window 23. For example, as shown in FIG. 2C and 2D, the handle 110 has fully extended the sheath 40, the second tubular member 20 may be resting on the stop 27 (which is the top of the fastener 35 in this example), and the indicia 35 visible in the viewing window 23 is “3”. In operation, using the handle 110, the sheath 40 may be extended and / or retracted any distance between fully retracted with the handle 110 in a fully extended position (e.g., as in FIG.2A and 2B) and fully extended with the handle 110 in fully compacted position (e.g., as in FIG.2C and 2D).

[0179] In step 1718, the second tubular member 20 may be locked to the third tubular member 30 using the lock 25. The lock 25 may be in a locked position. The second tubular member 20 may be secured to the third tubular member 30. The sheath 40 may be locked in position, and the distal end of the sheath 40 may be at the desired position in the subject. The needle 50 may still be locked in position and may still be shrouded by the sheath 40.

[0180] In step 1720, the stop 17 may be set to a desired position to limit the extension of the needle 50.

[0181] In step 1722, the first tubular member 10 may be unlocked from the second tubular member using the lock 15. The lock 15 may be in an unlocked position. In some embodiments (such as discussed with respect to FIGS. 11A, 1 IB, 12A, and 12B), the lock 15 may include at 74MEI 48657880v.1least one first user communicative indicator (e.g., first visual indicator 902, first tactile indicator 908, and / or first audible indicator 922) when the needle 50 is locked and at least one second user communicative indicator (e.g., second visual indicator 912, second tactile indicator 918, and / or second audible indicator 932) when the needle 50 is unlocked, where the first user communicative indicator and the second user communicative indicator are different. In some embodiments (such as discussed with respect to FIGS. 15A and 15B), the lock 15 may include at least a first tactile indicator (e.g., a sharp surface 1106) when the needle 50 is locked and at least a second tactile indicator (e.g., a digit resting surface 1104) when the needle 50 is unlocked, where the first user communicative indicator and the second user communicative indicator are different. In some embodiments (such as discussed with respect to FIGS. 19A, 19B, 20A, and 20B), the lock 15 may be in communication with the computer 1560 and provide different signals to the computer 1560 when the lock 15 is in a locked position and in an unlocked position. For this step, the computer 1560 may in turn modify a display to indicate the needle 50 is unlocked.

[0182] In step 1724, the first tubular member 10 may be slid or moved along the second tubular member 20 to extend the needle 50 through the second tubular member 20, the third tubular member, and out the distal end 112 of the handle 110. The distal end 42 of the needle 50 may be extended from the opening 43 at the distal end 42 of the sheath 44 and into the subject. The user may operate the first tubular member 10 to extend the needle 50 from the distal end 42 of the sheath 40. The needle 50 may be extended and / or moved to a desired position in the subject (e.g., to a desired position in a tumor). The user may determine how far the needle 50 is extended by viewing the viewing the indicia 24 through the viewing window 13. For example, as shown in FIG. 2C and 2D, the handle 110 has fully extended the needle 50, the first tubular 75MEI 48657880v.1member 10 may be resting on the stop 17, and the indicia 25 visible in the viewing window 13 is “5”. In operation, using the handle 110, the needle 50 may be extended and / or retracted any distance between fully retracted with the handle 110 in a fully extended position (e.g., as in FIG.2A and 2B) and fully extended with the handle 110 in fully compacted or retracted position (e.g., as in FIG. 2C and 2D).

[0183] In step 1726, the first tubular member 10 may be locked to the second tubular member 20. The lock 15 may be in a locked position. The first tubular member 10 is secured to the second tubular member 20. The needle may be locked in the desired position. In some embodiments (such as discussed with respect to FIGS. 19A, 19B, 20A, and 20B), the lock 15 may be in communication with the computer 1560 and provide different signals to the computer 1560 when the lock 15 is in a locked position and in an unlocked position. For this step, the computer 1560 may in turn modify a display to indicate the needle 50 is locked. Once the needle 50 is locked, the computer 1560 may unlock the pump 1520.

[0184] In step 1728, the fluid (or more generally the medical substance) may be injected into the tumor of the subject. In some embodiments, the computer 1560 may control, with oversight by the user, the amount and rate of the fluid injected by the pump 1520. The computer 1560 may modify a display to indicate a status of the pump 1520 and / or a status of the injection.

[0185] In step 1730, the operations may be reversed, and the needle 50 and sheath 40 may be withdrawn from the subject.

[0186] FIG. 25 depicts an example flowchart for a method of using the example injection device 100 according to one or more embodiments described herein. While an order of operations is indicated in FIG. 25 for illustrative purposes, the timing and ordering of such76MEI 48657880v.1operations may vary where appropriate without negating the purpose and advantages of the examples set forth in detail herein.

[0187] In step 1002, the working channel (e.g., a scope working channel, an extended working channel, a robot working channel) may be inserted into the subject.

[0188] In step 1004, the sheath 40 and the needle 50 may be inserted into the working channel. The needle 50 may be shrouded by the sheath 40.

[0189] In step 1006, the sheath 40 may be unlocked using a lock 25, 625. The lock 25, 625 may be configured to secure and unsecure the sheath 40 from extending from a handle 110. Additionally, the lock 25, 625 may be configured to secure and unsecure the sheath 40 from retracting into the handle 110. The lock 25, 625 may be moved or switched into an unlocked position to unlock the sheath 40. While in the unlocked position, the lock 25, 625 may disengage the second tubular member 20 from the third tubular member 30. The sheath 40 may be unlocked and allowed to move.

[0190] In step 1008, the handle 110 may be attached to the working channel. The handle 110 may be connected to the sheath 40 and the needle 50. The handle 110 may be locked to the working channel using the fastener 35. The distal end 42 of the sheath 40 may be now located at the distal end of the working channel and near the opening at the distal end of the working channel.

[0191] In step 1010, the second tubular member 20 may be slid or moved along the third tubular member 30 to extend the sheath 40 from the distal end of the working channel, out from the opening at the distal end of the working channel, and into the subject. The user may operate the second tubular member 20 to extend the sheath 40 from the distal end of the working channel. The sheath 40 may be extended to a desired position in the subject. The user may 77MEI 48657880v.1determine how far the sheath 40 is extended by viewing the viewing the indicia 34 through the viewing window 23. For example, as shown in FIG. 2C and 2D, the handle 110 has fully extended the sheath 40, the second tubular member 20 may be resting on the stop 27 (which is the top of the fastener 35 in this example), and the indicia 35 visible in the viewing window 23 is “3”. In operation, using the handle 110, the sheath 40 may be extended and / or retracted any distance between fully retracted with the handle 110 in a fully extended position (e.g., as in FIG.2A and 2B) and fully extended with the handle 110 in fully compacted position (e.g., as in FIG.2C and 2D).

[0192] In step 1012, the sheath 40 may be locked in position using the lock 25. The lock 25, 625 may be moved or switched into an locked position to lock the sheath 40. While in the locked position, the second tubular member 20 may be secured to the third tubular member 30. When the second tubular member 20 is secured to the third tubular member, the sheath 40 may be locked in position, and the distal end of the sheath 40 may be at the desired position in the subject. The needle 50 may still be locked in position and may still be shrouded by the sheath 40.

[0193] In step 1014, the first tubular member 10 may be unlocked using the lock 15. The lock 15 may be in an unlocked position.

[0194] In step 1016, the first tubular member 10 may be slid or moved along the second tubular member 20 to extend the needle 50 through the second tubular member 20, the third tubular member, and out the distal end 112 of the handle 110. The distal end 42 of the needle 50 may be extended from the opening 43 at the distal end 42 of the sheath 44 and into the subject. The user may operate the first tubular member 10 to extend the needle 50 from the distal end 42 of the sheath 40. The needle 50 may be extended and / or moved to a desired position in the 78MEI 48657880v.1subject (e.g., to a desired position in a tumor). The user may determine how far the needle 50 is extended by viewing the viewing the indicia 24 through the viewing window 13. For example, as shown in FIG. 2C and 2D, the handle 110 has fully extended the needle 50, the first tubular member 10 may be resting on the stop 17, and the indicia 25 visible in the viewing window 13 is “5”. In operation, using the handle 110, the needle 50 may be extended and / or retracted any distance between fully retracted with the handle 110 in a fully extended position (e.g., as in FIG.2A and 2B) and fully extended with the handle 110 in fully compacted or retracted position (e.g., as in FIG. 2C and 2D).

[0195] In step 1018, the needle 50 may be locked in position using the lock 15.Additionally, the first tubular member 10 may be locked to the second tubular member 20. The lock 15 may be in a locked position. The first tubular member 10 is secured to the second tubular member 20. The needle may be locked in the desired position.EXAMPLE FLOWCHART FOR MEDICAL INJECTION WITH INJECTION LOCKOUT

[0196] FIG. 27 depicts an example flowchart for a method 1800 for medical injection with injection lockout of using an example injection device 100B, such as discussed above with respect to FIGS. 19A, 19B, 20A, and 20B, according to one or more embodiments described herein. In some embodiments, steps 1808, 1810, 1814, and 1818 of the method of FIG. 27 may be computer-implemented steps or have aspects that are computer-implemented. Such steps of the method of FIG. 27 may be implemented using any suitable system or apparatus, such as the apparatus 1600 of FIG. 23. As an example, the computer 1560 be implemented by an apparatus 1600. While an order of operations is indicated in FIG. 27 for illustrative purposes, the timing79MEI 48657880v.1and ordering of such operations may vary where appropriate without negating the purpose and advantages of the examples set forth in detail herein.

[0197] In step 1802, the injection needle 50 may be placed in a tumor of the subject using the injection device 100B. Step 1802 may be performed according to steps 1702 to 1724 of FIG. 24.

[0198] In step 1804, the user may confirm that the needle 50 is in proper position in the tumor.

[0199] In step 1806, the lock 15B may be moved to a locked position.

[0200] In step 1808, once lock 15B is in the locked position, a circuit may be completed between the first tubular member 10B and the second tubular member 20B. An electrical connection (e.g., a closed circuit) may be made between the slide member 440B and the teeth 450B. Signal(s) indicating completion of the circuit or an electrical connection between the first tubular member 10B and the second tubular member 20B may be sent by the injection device 100B to the computer 1560. Step 1808 may be performed according to steps 1726 of FIG. 24.

[0201] In step 1810, after a circuit is completed between the first tubular member 10B and the second tubular member 20B, a visual indication of “Lock” (or “Needle Locked” or other similar indication of word(s) and / or symbol(s)) may be displayed on a screen of the computer 1560. Such a visual indication may indicate that the needle 50 is in a locked position.

[0202] In step 1812, the injection pump 1520 may be activated but in a locked operating condition (e.g., unable to pump).

[0203] In step 1814, after a circuit is completed between the first tubular member 10B and the second tubular member 20B, the injection pump 1520 may be switched to an unlocked operating condition (e.g., able to pump) by the computer 1560.80MEI 48657880v.1

[0204] In step 1816, if the pump is an unlocked operating condition, the injection substance may be injected into the tumor of the subject. Step 1802 may be performed according to steps 1728 of FIG. 24.

[0205] In step 1818, if the lock 15B is moved in the unlocked position, a circuit is no longer completed between the first tubular member 10B and the second tubular member 20B. An open circuit may be made between the slide member 440B and the teeth 450B. Signal(s) indicating no circuit or no electrical connection between the first tubular member 10B and the second tubular member 20B may be sent by the injection device 100B to the computer 1560. The injection pump 1520 may be switched to a locked operating condition (e.g., unable to pump) by the computer 1560. A visual indication of “Unlock” (or “Needle Unlocked” or other similar indication of word(s) and / or symbol(s)) may be displayed on the screen of the computer 1560. Such a visual indication may indicate that the needle 50 is in an unlocked position.

[0206] FIG. 26 depicts an example flowchart for a method 900 for medical injection of using the example injection device 100 (or 400 or 600) according to one or more embodiments described herein. While an order of operations is indicated in FIG. 26 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.

[0207] In step 902, the working channel (e.g., a scope working channel, an extended working channel, a robot working channel) is inserted into the subject.

[0208] In step 904, the sheath 40 and the needle 50 are inserted into the working channel. The needle 50 is shrouded by the sheath 40.

[0209] In step 906, the handle 110 is attached to the working channel. The handle 110 is connected to the sheath 40 and the needle 50. The handle 110 is locked to the working channel 81MEI 48657880v.1using the fastener 35. The distal end 42 of the sheath 40 is now located at the distal end of the working channel and near the opening at the distal end of the working channel.

[0210] In step 908, the second tubular member 20 is slid or moved along the third tubular member 30 to extend the sheath 40 from the distal end of the working channel, out from the opening at the distal end of the working channel, and into the subject. The user operates the second tubular member 20 to extend the sheath 40 from the distal end of the working channel. The sheath 40 is extended to a desired position in the subject. The user may determine how far the sheath 40 is extended by viewing the viewing the indicia 34 through the viewing window 23. For example, as shown in FIG. 2C and 2D, the handle 110 has fully extended the sheath 40, the second tubular member 20 is resting on the stop 27 (which is the top of the fastener 35 in this example), and the indicia 35 visible in the viewing window 23 is “3”. In operation, using the handle 110, the sheath 40 may be extended and / or retracted any distance between fully retracted with the handle 110 in a fully extended position (e.g., as in FIG. 2A and 2B) and fully extended with the handle 110 in fully compacted position (e.g., as in FIG. 2C and 2D).

[0211] In step 910, the second tubular member 20 is locked to the third tubular member 30 using the lock 25. The lock 25 is in a locked position. The second tubular member 20 is secured to the third tubular member 30. The sheath 40 is locked in position, and the distal end of the sheath 40 is at the desired position in the subject. The needle 50 is still locked in position and is still shrouded by the sheath 40.

[0212] In step 912, the needle is unlocked by depressing a needle lock control 4151 of a lock 415. The lock 415 may be biased into a locked position by a biasing member 41. The lock 415 may be switched into an unlocked state by the depressing of the needle lock control 4151. While82MEI 48657880v.1in the unlocked state, the first tubular member 10 may be unlocked from the second tubular member 20 and the needle 50 may be able to extend form the sheath 40.

[0213] In step 914, the needle lock control 4151 is slid or moved within a lock control channel 4156 to slide or move the first tubular member 10 along the second tubular member 20 to extend the needle 50 through the second tubular member 20, the third tubular member, and out the distal end 112 of the handle 110. In an embodiment, extending the needle may comprise supporting movement of the needle lock side controls using a direction support feature 6157. The distal end 42 of the needle 50 is extended from the opening 43 at the distal end 42 of the sheath 44 and into the subject. The user operates the first tubular member 10 to extend the needle 50 from the distal end 42 of the sheath 40. The needle 50 is extended and / or moved to a desired position in the subject (e.g., to a desired position in a tumor). The user may determine how far the needle 50 is extended by viewing the viewing the indicia 24 through the viewing window 13. For example, as shown in FIG. 2C and 2D, the handle 110 has fully extended the needle 50, the first tubular member 10 is resting on the stop 17, and the indicia 25 visible in the viewing window 13 is “5”. In operation, using the handle 110, the needle 50 may be extended and / or retracted any distance between fully retracted with the handle 110 in a fully extended position (e.g., as in FIG. 2A and 2B) and fully extended with the handle 110 in fully compacted or retracted position (e.g., as in FIG. 2C and 2D).

[0214] In step 916, the first tubular member 10 is locked to the second tubular member 20 by releasing needle lock control of a lock 415. The lock 415 is biased back into the locked state by the biasing member 4154 when the needle lock control 4151 is released. The first tubular member 10 is secured to the second tubular member 20. The needle 50 is locked in the desired position.83MEI 48657880v.1

[0215] In the embodiments described throughout this disclosure, the fluid, liquid medicant, or injection substance can be 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, INchCh, Sn Ch, 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, OsCh, IrCh, PtO, PtCh, HgO, Hg2O, TI2O3, PbO, Pb2O3, Pb3O4, 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 biocompatible coating can include phosphates (for example an orthophosphate, an oligophosphate, a polyphosphate, a metaphosphate, a pyrophosphate, etc.), carboxylates (for example citrate, di carboxylic acid, succinic acid), and sulphates. Contemplated phosphates include sodium trimetaphosphate and sodium hexametaphosphate. In some embodiments, the nanoparticles or nanoparticle aggregates have a 84MEI 48657880v.1density 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.

[0216] 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).

[0217] 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.

[0218] In addition to the embodiments and disclosures provided above, which may be claimed individually, separately, in part or in combination, with features from the entire disclosure provided herein, the following numbered embodiments may be claimed individually, separately, in part or in combination, with features from the entire disclosure provided herein:85MEI 48657880v.11. A medical injection device, comprising:a handle to administer injection to a subject, the handle having a proximal end and a distal end, the proximal end configured to attach to an injection substance supply and the distal end configured to attach to a working channel, the handle comprising a plurality of nested tubular members;a needle having a proximal end, a distal end, and a lumen configured to convey injection substance from the proximal end to the distal end;a 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; anda lock configured to selectively (1) prevent the sheath from extending and retracting from the medical injection device, and (2) permit the sheath to extend and retract from the medical injection device, and to communicate at least two operating conditions of the lock, 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 from the working channel.2. The medical injection device of numbered embodiment 1, wherein the lock is connected to, integrated into, or part of a tubular member of the plurality of nested tubular members.86MEI 48657880v.13. The medical injection device of numbered embodiment 2, wherein the lock is configured to secure and unsecure the tubular member to another tubular member of the plurality of nested tubular members, wherein the another tubular member is nested in the tubular member.4. The medical injection device of numbered embodiment 3, wherein the another tubular member is configured to secure and unsecure the handle to a medical procedure device.5. The medical injection device of numbered embodiment 2, wherein the sheath is connected to an interior of the tubular member.6. The medical injection device of numbered embodiment 1, wherein the lock is configured to lock and unlock two tubular members of the plurality of nested tubular members.7. The medical injection device of numbered embodiment 1, wherein the lock comprises a thumb screw.8. The medical injection device of numbered embodiment 7, wherein the thumb screw is configured to engage and disengage with a nested tubular member of the plurality of tubular members.9. The medical injection device of numbered embodiment 7, wherein the thumb screw has a locked position to lock together two tubular members of the plurality of nested tubular members and an unlocked position to unlock the two tubular members.87MEI 48657880v.110. The medical injection device of numbered embodiment 1, wherein the lock comprises a cam lever.11. The medical injection device of numbered embodiment 10, wherein the cam lever is configured to engage and disengage with a nested tubular member of the plurality of tubular members.12. The medical injection device of numbered embodiment 10, wherein the cam lever has a locked position to lock together two tubular members of the plurality of nested tubular members and an unlocked position to unlock the two tubular members.13. The medical injection device of numbered embodiment 1, wherein in a first operating condition of the at least two operating conditions of the lock, the lock is in a locked position, and the sheath is in a locked position and prevented from moving,wherein in a second operating condition of the at least two operating conditions of the lock, the lock is in an unlocked position, and the sheath is in an unlocked position and permitted to move.14. The medical injection device of numbered embodiment 13, wherein the lock comprises a first visual indicator to indicate the locked position of the lock and a second visual indicator to indicate the unlocked position of the lock.88MEI 48657880v.115. The medical injection device of numbered embodiment 14, wherein the lock comprises a thumb screw and a shroud partially covering the thumb screw,wherein when the first visual indicator is visible, the second visual indicator is hidden from view by the shroud,wherein when the second visual indicator is visible, the first visual indicator is hidden from view by the shroud.16. The medical injection device of numbered embodiment 14, wherein the lock comprises a cam lever,wherein the first visual indicator is on a first side of the cam lever,wherein the second visual indicator is on a second side of the cam lever, the first side being opposite to the second side.17. The medical injection device of numbered embodiment 1, further comprising a translation lock, wherein the translation lock is configured to engage and disengage with the lock to lock and unlock, respectively, the needle from traversing in a distal direction.18. The medical injection device of numbered embodiment 1, wherein the lock comprises a cam lever configured to engage and disengage with the translation lock.19. A method for injecting a substance into a subject, comprising:inserting a working channel into a subject;inserting a needle shrouded by a sheath into the working channel;89MEI 48657880v.1unlocking the sheath with a first lock;attaching a handle to the working channel, the handle connected to the needle and the sheath, the handle comprising a plurality of nested tubular members, the plurality of nested tubular members comprising a first tubular member and a second tubular member;extending the sheath from a distal end of the working channel by operating the second tubular member of the plurality of nested tubular members;locking the sheath in position with the first lock;unlocking the first tubular member using a second lock;extending the needle from a distal end of the sheath by operating the first tubular member of the plurality of nested tubular members; andlocking the needle in position.20. The method of numbered embodiment 19, wherein the first lock is configured to secure and unsecure the sheath from extending from the handle and is configured to secure and unsecure the sheath from retracting into the handle.21. A medical injection device, comprising:a handle to administer injection to a subject, having a proximal end and a distal end, the proximal end configured to attach to an injection substance supply and the distal end configured to attach to a working channel, the handle comprising a first tubular member and a second tubular member;a needle having a proximal end, a distal end, and a lumen configured to convey injection substance from the proximal end to the distal end;90MEI 48657880v.1a 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; anda lock comprising (i) a needle lock control configured to secure and unsecure the second tubular member to the first tubular member and (ii) at least one first body disposed on an interior of the first tubular member, wherein the lock is configured to selectively (1) prevent the needle from extending and retracting from the sheath and (2) permit the needle to extend and retract from the sheath,wherein the first tubular member and second tubular member are user operable to move independently of each other,wherein the first tubular member and second tubular member are user operable to independently extend and retract the needle and the sheath from the working channel.22. The medical injection device of numbered embodiment 21, wherein the second tubular member comprises at least one second body disposed on a proximal end of the second tubular member, wherein the at least second body is configured to engage the at least one first body of the at least one first body in a locked state.23. The medical injection device of numbered embodiment 22, wherein the at least one first body comprises a plurality of recesses extending along a length of an interior wall of the first tubular member and the at least one second body comprises at least one protrusion extending from the proximal end of the second tubular member.91MEI 48657880v.124. The medical injection device of numbered embodiment 23, wherein the lock further comprises a biasing member configured to bias each of the at least one protrusion into engagement with one recess of the plurality of recesses in the locked state.25. The medical injection device of numbered embodiment 24, wherein the needle lock control is configured to disengage the at least one protrusion from the one recess when the needle lock control is depressed and adjust the lock into an unlocked state.26. The medical injection device of numbered embodiment 22, wherein the at least one first body comprises a first friction member disposed on the interior of the first tubular member.27. The medical injection device of numbered embodiment 26, wherein the at least one comprises a second friction member disposed on the proximal end of the second tubular member, wherein the second friction member is configured to engage the first friction member to prevent the needle from extending and retracting from the sheath in a locked state.28. The medical injection device of numbered embodiment 27, wherein the lock further comprises a biasing member configured to bias the second friction member into engagement with the first friction member.92MEI 48657880v.129. The medical injection device of numbered embodiment 27, wherein the needle lock control is configured to disengage the second friction member from the first friction member when the needle lock control is depressed and adjust the lock into an unlocked state.30. A medical injection device, comprising:a handle to administer injection to a subject, having a proximal end and a distal end, the proximal end configured to attach to an injection substance supply and the distal end configured to attach to a working channel, the handle comprising a first tubular member and a second tubular member, the second tubular member comprising at least one protrusion and a biasing member configured to bias the at least one protrusion towards the first tubular member;a needle having a proximal end, a distal end, and a lumen configured to convey injection substance from the proximal end to the distal end;a 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; anda lock configured to selectively (1) prevent the needle from extending and retracting from the sheath and (2) permit the needle to extend and retract from the sheath,wherein the first tubular member and second tubular member are user operable to move independently of each other,wherein the first tubular member and second tubular member are user operable to independently extend and retract the needle and the sheath from the working channel.31. The medical injection device of numbered embodiment 30, wherein the lock is configured to lock and unlock the second tubular member relative to the first tubular member.93MEI 48657880v.132. The medical injection device of numbered embodiment 31, wherein the lock is integrated into or part of the first tubular member.33. The medical injection device of numbered embodiment 32, wherein the lock comprises a needle lock control configured to secure and unsecure the second tubular member to the first tubular member, wherein the second tubular member is nested in the first tubular member.34. The medical injection device of numbered embodiment 33, wherein the needle lock control is biased into the locked state by the biasing member.35. The medical injection device of numbered embodiment 33, wherein the needle lock control comprises needle lock side controls disposed on opposing sides of the first tubular member.36. The medical injection device of numbered embodiment 35, wherein the needle lock side controls are configured to adjust the lock into an unlocked state when the needle lock side controls are depressed.37. The medical injection device of numbered embodiment 36, wherein the needle lock side controls are configured to move within a lock control channel to permit the needle to extend and retract from the sheath when in the unlocked state.94MEI 48657880v.138. The medical injection device of numbered embodiment 35, wherein the needle lock side controls comprise a direction support feature configured to support movement of the needle lock side controls.39. A method for injecting a substance into a subject, comprising:inserting a working channel into a subject;inserting a needle shrouded by a sheath into the working channel;attaching a handle to the working channel, the handle connected to the needle and the sheath, the handle comprising a plurality of nested tubular members, the plurality of nested tubular members comprising a first tubular member and a second tubular member;extending the sheath from a distal end of the working channel by operating the second tubular member of the plurality of nested tubular members;locking the sheath in position;unlocking the needle by depressing a needle lock control of a lock, wherein the lock is biased into a locked state;extending the needle from a distal end of the sheath by moving the needle lock control; locking the needle in position by releasing the needle lock control; andinjecting the substance into the subject from the needle.40. The method of numbered embodiment 39, wherein extending the needle comprises supporting movement of the needle lock side controls using a direction support feature.95MEI 48657880v.1

Claims

1. CLAIMSWhat is claimed is:

1. A medical injection device, comprising:a handle to administer injection to a subject, the handle having a proximal end and a distal end, the proximal end configured to attach to an injection substance supply, and the distal end configured to attachment to a working channel, the handle comprising a plurality of nested tubular members;a 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 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,wherein the plurality of nested tubular members are user operable to move independently of each other, andwherein the plurality of nested tubular members are user operable to independently extend and retract the needle and the sheath from the working channel.

2. The medical injection device of claim 1, wherein the plurality of nested tubular members comprises a first tubular member having a proximal end configured to attachment to the injection substance supply and a distal end, wherein an inner portion of the first tubular member is attached to the proximal end of the needle.

3. The medical injection device of claim 2, wherein the first tubular member is configured to slide along a longitudinal direction of a second tubular member.96MEI 48657880v.

14. The medical injection device of claim 2, wherein the first tubular member is configured to move back-and-forth between a first position and a second position with respect to a second tubular member.

5. The medical injection device of claim 4, wherein, when the first tubular member is in the first position, a bevel tip at the distal end of the needle is shrouded by the sheath, and wherein, when the first tubular member is in the second position, the bevel tip at the distal end of the needle is not shrouded by the sheath.

6. The medical injection device of claim 2, further comprising a user operable lock to lock the first tubular member with respect to a second tubular member.

7. The medical injection device of claim 2, further comprising a stop to prevent the first tubular member from moving past a stopping position on a second tubular member.

8. The medical injection device of claim 7, wherein the stop is operable to move back-and-forth along a longitudinal direction of the second tubular member.

9. The medical injection device of claim 2, wherein the first tubular member is configured to convey injection substance from the proximal end of the first tubular member to the proximal end of the needle.

10. The medical injection device of claim 1, wherein the plurality of nested tubular members comprises a second tubular member having a proximal end located within a first tubular member and a distal end, wherein an inner portion of the second tubular member is97MEI 48657880v.1attached to the proximal end of the sheath, wherein the distal end of the first tubular member is configured to move along an exterior of the second tubular member.

11. The medical injection device of claim 10, wherein the second tubular member is configured to slide along a longitudinal direction of a third tubular member.

12. The medical injection device of claim 10, wherein the second tubular member is configured to move back-and-forth between a first position and a second position with respect to a third tubular member.

13. The medical injection device of claim 12, wherein, when the second tubular member is in the first position, the sheath is retracted within the working channel, and wherein, when the second tubular member is in the second position, the sheath is extended from the working channel.

14. The medical injection device of claim 10, further comprising a user operable lock to lock the second tubular member with respect to a third tubular member.

15. The medical injection device of claim 10, further comprising a stop to prevent the second tubular member from moving past a stopping position on a third tubular member.

16. The medical injection device of claim 15, wherein the stop is operable to connect the handle to the working channel.

17. The medical injection device of claim 1, wherein the plurality of nested tubular members comprises a third tubular member having a proximal end located within a second98MEI 48657880v.1tubular member and a distal end configured to attachment to the working channel, wherein the needle and the sheath extend from distal end of the third tubular member, wherein the distal end of the second tubular member is configured to move along an exterior of the third tubular member.

18. The medical injection device of claim 17, further comprising a fastener to attach the distal end of the third tubular member to the working channel.

19. The medical injection device of claim 1, wherein the handle further comprises a lock configured to prevent the needle from moving.

20. The medical injection device of claim 19, wherein the lock is user operable to move back-and-forth between a locked position and an unlocked position,wherein when the lock is in a locked position, the needle is in a locked position and prevented from moving, andwherein when the lock is in an unlocked position, the needle is in an unlocked position and permitted to move.

21. The medical injection device of claim 20, wherein when the lock is in the locked position, two tubular members of the plurality of nested tubular members are locked together and prevented from moving independently of each other, andwherein when the lock is in the unlocked position, the two tubular members are unlocked from each other and permitted to move independently of each other.99MEI 48657880v.

122. The medical injection device of claim 21, wherein when the lock is in the locked position, a third tubular member of the plurality of nested tubular members is not locked together with the two tubular members by the lock, andwherein when the lock is in the unlocked position, the third tubular member is not locked together with the two tubular members by the lock.

23. The medical injection device of claim 19, wherein when the lock is in a locked position, the needle is prevented from being extended and retracted from the distal end of the sheath, andwherein when the lock is in an unlocked position, the needle is permitted to be extended and retracted from the distal end of the sheath.

24. The medical injection device of claim 19, wherein the lock is configured to lock and unlock together two tubular members of the plurality of nested tubular members.

25. The medical injection device of claim 19, wherein the lock is movable between a locked position to lock together two tubular members of the plurality of nested tubular members and an unlocked position to unlock together the two tubular members.

26. The medical injection device of claim 19, wherein the lock is user operable to slide back-and-forth between the locked position and the unlocked position.

27. The medical injection device of claim 19, wherein the lock comprises a slide member attached to a first tubular member of the plurality of nested tubular members.100MEI 48657880v.

128. The medical injection device of claim 27, wherein the slide member of the lock comprises an opening, wherein the needle passes through the opening of the slide member.

29. The medical injection device of claim 27, wherein the slide member of the lock is configured to slide between a locked position and an unlocked position,wherein when the slide member is in the locked position, the needle is in a locked position and prevented from moving, andwherein when the slide member is in the unlocked position, the needle is in an unlocked position and permitted to move.

30. The medical injection device of claim 27, wherein the slide member of the lock is configured to engage and disengage teeth of a second tubular member of the plurality of nested tubular members, wherein the second tubular member is nested within the first tubular member31. The medical injection device of claim 27, wherein the slide member of the lock comprises a first portion and a second portion opposite the first portion,wherein the first portion is visible when the slide member is in a locked position and not visible when the slide member is in an unlocked position, andwherein the second portion is not visible when the slide member is in a locked position and visible when the slide member is in an unlocked position.

32. The medical injection device of claim 31, wherein the slide member of the lock comprises a first end face and a second end face opposite the first end face,wherein the first end face is visible when the slide member is in the locked position and in the unlocked position, and101MEI 48657880v.1wherein the second end face visible when the slide member is in the locked position and in the unlocked position.

33. The medical injection device of claim 31, wherein the lock is attached to a first tubular member of the plurality of nested tubular members,wherein the lock comprises an end ring at a distal end of the first tubular member, wherein the first portion is covered by the end ring when the slide member is in a locked position and not covered by the end ring when the slide member is in an unlocked position, and wherein the second portion is not covered by the end ring when the slide member is in the locked position and covered by the end ring when the slide member is in the unlocked position.

34. The medical injection device of claim 19, wherein the lock is configured to communicate at least two operating conditions of the lock.

35. The medical injection device of claim 34, wherein the lock comprises a first operating condition and a second operating condition different from the first operating condition, wherein the lock comprises a first user communicative indicator and a second user communicative indicator different from the first user communicative indicator, and wherein the first and second user communicative indicators correspond to the first and second operating conditions of the lock, respectively.

36. The medical injection device of claim 35, wherein in the first operating condition of the lock, the lock is in a locked position, and the needle is in a locked position and prevented from moving, and102MEI 48657880v.1wherein in the second operating condition of the lock, the lock is in an unlocked position, and the needle is in an unlocked position and permitted to move.

37. The medical injection device of claim 35, wherein the first and second user communicative indicators are at least one of a pair of visual indicators, a pair of tactile indicators, or a pair of audible indicators.

38. The medical injection device of claim 34, wherein when the lock is in a locked position, the lock has a first visual indicator, and the needle is in a locked position and prevented from moving,wherein when the lock is in an unlocked position, the lock has a second visual indicator, and the needle is in an unlocked position and permitted to move, andwherein the first visual indicator and the second visual indicator differ by at least one of symbol or color.

39. The medical injection device of claim 38, wherein when the lock is in a locked position, the first visual indicator is visible to a user of the medical injection device and the second visual indicator is not visible to a user of the medical injection device, andwherein when the lock is in an unlocked position, the first visual indicator is not visible to a user of the medical injection device and the second visual indicator is visible to a user of the medical injection device.

40. The medical injection device of claim 34, wherein when the lock is in a locked position, the lock has a first tactile indicator, and the needle is in a locked position and prevented from moving,103MEI 48657880v.1wherein when the lock is in an unlocked position, the lock has a second tactile indicator, and the needle is in an unlocked position and permitted to move, andwherein the first tactile indicator and the second tactile indicator are different.

41. The medical injection device of claim 40, wherein when the lock is in a locked position, the first tactile indicator protrudes from a first side of a first tubular member of the plurality of nested tubular members,wherein when the lock is in an unlocked position, the second tactile indicator protrudes from a second side of the first tubular member of the plurality of nested tubular members, and wherein the first side of the first tubular member is opposite the second side of the first tubular member.

42. The medical injection device of claim 34, wherein when the lock is in a locked position, the needle is in a locked position and prevented from moving,wherein when the lock is in an unlocked position, the needle is in an unlocked position and permitted to move,wherein when the lock moves from the locked position to the unlocked position, the lock makes a first audible indicator, andwherein the first audible indicator and the second audible indicator are different.

43. The medical injection device of claim 34, wherein when the lock is in a locked position, the needle is in a locked position and prevented from moving, and the lock comprises at least one of a first visual indicator or a first tactile indicator of the locked position, wherein when the lock is in an unlocked position, the needle is in an unlocked position104MEI 48657880v.1and permitted to move, and the lock comprises at least one of a second visual indicator or a second tactile indicator of the unlocked position,wherein the first visual indicator and the second visual indicator are different, and wherein the first tactile indicator and the second tactile indicator are different.

44. The medical injection device of claim 43, wherein when the lock is in the locked position, two tubular members of the plurality of nested tubular members are locked together and prevented from moving independently of each other, andwherein when the lock is in the unlocked position, the two tubular members are unlocked from each other and permitted to move independently of each other.

45. The medical injection device of claim 43, wherein when the lock is in the locked position, a third tubular member of the plurality of nested tubular members is not locked together with the two tubular members by the lock, andwherein when the lock is in the unlocked position, the third tubular member is not locked together with the two tubular members by the lock.

46. The medical injection device of claim 34, wherein when the lock is in a locked position, the needle is prevented from being extended and retracted from the distal end of the sheath, andwherein when the lock is in an unlocked position, the needle is permitted to be extended and retracted from the distal end of the sheath.105MEI 48657880v.

147. The medical injection device of claim 34, wherein the two operating conditions of the lock comprise the lock configured to lock and unlock together two tubular members of the plurality of nested tubular members.

48. The medical injection device of claim 47, wherein the lock is user operable to slide back-and-forth between the locked position and the unlocked position.

49. The medical injection device of claim 34, wherein the lock comprises a slide member attached to a first tubular member of the plurality of nested tubular members, and wherein the slide member of the lock comprises an opening, wherein the needle passes through the opening of the slide member.

50. The medical injection device of claim 19, wherein the lock is configured to tactilely communicate operating conditions of the lock to a user.

51. The medical injection device of claim 50, wherein when the lock is in a locked position, a sharp surface is exposed, andwherein when the lock is in an unlocked position, the sharp surface is not exposed.

52. The medical injection device of claim 51, wherein the lock comprises a slide member attached to a first tubular member of the plurality of nested tubular members, the slide member comprising the sharp surface.

53. The medical injection device of claim 52, wherein the sharp surface is on a proximal side of the slide member.106MEI 48657880v.

154. The medical injection device of claim 50, wherein when the lock is in a locked position, a digit resting surface is not exposed,wherein when the lock is in an unlocked position, the digit resting surface is exposed.

55. The medical injection device of claim 54, wherein the digit resting surface is a smooth surface or a substantially smooth surface.

56. The medical injection device of claim 54, wherein the lock comprises a slide member attached to a first tubular member of the plurality of nested tubular members, the slide member comprising the digit resting surface.

57. The medical injection device of claim 56, wherein the digit resting surface is on a proximal side of the slide member.

58. The medical injection device of claim 56, wherein the first tubular member comprises an asymmetrical protrusion at a proximal end of the first tubular member, wherein when the lock is in the unlocked position, the slide member protrudes from the asymmetrical protrusion of the first tubular member.

59. The medical injection device of claim 50, wherein when the lock is in a locked position, a sharp surface of the lock is exposed, and a digit resting surface of the lock is not exposed, andwherein when the lock is in an unlocked position, the sharp surface of the lock is not exposed, and the digit resting surface of the lock is exposed.107MEI 48657880v.

160. The medical injection device of claim 59, wherein the lock comprises a slide member attached to a first tubular member of the plurality of nested tubular members, the slide member comprising the sharp surface and the digit resting surface.

61. The medical injection device of claim 60, wherein the first tubular member is configured to be gripped by a user,wherein when the lock is in the locked position, the sharp surface of the slide member is positioned to be touchable by at least one of one a thumb or a finger of a user, and wherein when the lock is in the unlocked position, the sharp surface of the slide member is positioned to not be touchable by at least one of one a thumb or a finger of a user.

62. The medical injection device of claim 60, wherein when the lock is in the locked position, the slide member protrudes from a first side of the first tubular member by a first distance, andwherein when the lock is in the unlocked position, the slide member protrudes from a second side of the first tubular member opposite the first side by the first distance.

63. The medical injection device of claim 60, wherein the first tubular member comprises an asymmetrical protrusion at the proximal end, andwherein when the lock is in the unlocked position, the slide member protrudes from the asymmetrical protrusion the first tubular member.

64. The medical injection device of claim 50, wherein the plurality of nested tubular members comprises a first tubular member having a distal end and a proximal end, wherein the first tubular member comprises an asymmetrical protrusion at the distal end,108MEI 48657880v.1andwherein a proximal side of the asymmetrical protrusion comprises a digit resting surface.

65. The medical injection device of claim 50, wherein the lock comprises a first operating condition in which the lock is in a locked position, and the needle is in a locked position and prevented from moving,wherein the lock comprises a first operating condition in which the lock is in an unlocked position, and the needle is in an unlocked position and permitted to move,wherein the lock comprises a first tactile indicator and a second tactile indicator different from the first tactile indicator, andwherein the first and second tactile indicators correspond to the first and second operating conditions of the lock, respectively.

66. The medical injection device of claim 50, wherein the lock is user operable to slide back-and-forth between the locked position and the unlocked position.

67. The medical injection device of claim 19, wherein the handle further comprises a lock configured to prevent the needle from moving and to communicate operating conditions of the lock to a computer apparatus.

68. The medical injection device of claim 67, wherein the lock is attached to a first tubular member of the plurality of nested tubular members and comprises a first portion configured to engage with and make an electrical connection with a second portion of a second tubular member of the plurality of nested tubular members.109MEI 48657880v.

169. The medical injection device of claim 68, wherein the lock comprises a slide member attached to the first tubular member, wherein the slide member includes the first portion.

70. The medical injection device of claim 68, wherein the second tubular member comprises a plurality of teeth, wherein the plurality of teeth includes the second portion.

71. The medical injection device of claim 70, wherein at least one groove of the plurality of teeth does not include the second portion.

72. The medical injection device of claim 70, wherein the at least one groove is at an end of a row of the plurality of teeth.

73. The medical injection device of claim 67, wherein the lock comprises a slide member attached to a first tubular member of the plurality of nested tubular members, wherein the second tubular member of the plurality of nested tubular members comprises a plurality of teeth,wherein, in a first operating condition, the lock is in a locked position, and the slide member is electrically connected to the teeth, andwherein, in a second operating condition, the lock is in an unlocked position, and the slide member is not electrically connected to the teeth.

74. The medical injection device of claim 73, wherein, in a third operating condition, the slide member is not electrically connected to the teeth, and the lock is in a locked position.

75. The medical injection device of claim 74, wherein, in the third operating condition, the handle is in a fully extended position.110MEI 48657880v.

176. The medical injection device of claim 67, wherein when the lock is in a locked position, the handle is configured to provide a locked signal to the computer apparatus, and wherein when the lock is in an unlocked position, the handle is configured to provide an unlocked signal to the computer apparatus.

77. The medical injection device of claim 76, wherein when the lock is in the locked position and further when the handle is in a fully extended position, the handle is configured to provide the unlocked signal to the computer apparatus.

78. The medical injection device of claim 77, wherein when the lock is in the locked position and further when the handle is not in the fully extended position, the handle is configured to provide the locked signal to the computer apparatus.

79. The medical injection device of claim 67, further comprising the computer apparatus, wherein the computer apparatus comprises:one or more processors; andmemory accessible by the one or more processors, the memory storing instructions that are executable by the one or more processors,wherein the computer apparatus is configured to be in communication with the handle, andwherein the computer apparatus is configured to be in communication with an injection system to provide the injection substance.IllMEI 48657880v.

180. The medical injection device of claim 67, wherein when the computer apparatus receives a signal from the handle indicating the lock is in an unlocked position, the computer apparatus is configured to prevent the injection system from providing the injection substance to the handle.

81. The medical injection device of claim 80, wherein when the computer apparatus receives a signal from the handle indicating the lock is in a locked position, the computer apparatus is configured to permit the injection system to provide the injection substance to the handle.

82. The medical injection device of claim 81, wherein when the computer apparatus receives the signal from the handle indicating the lock is in the unlocked position, the computer apparatus is configured to provide a visual indicator for a user indicating the injection system is prevented from providing the injection substance supply to the handle, andwherein when the computer apparatus receives the signal from the handle indicating the lock is in the locked position, the computer apparatus is configured to provide a visual indicator for a user indicating the injection system is permitted to provide the injection substance supply to the handle.

83. The medical injection device of claim 1, comprising a fastener at the distal end of the handle configured to secure the handle to the working channel and to permit the handle to rotate until the handle is secured to the working channel.

84. The medical injection device of claim 83, wherein the handle and the fastener are configured to rotated independently of each other about a central longitudinal axis of the handle.112MEI 48657880v.

185. The medical injection device of claim 83, wherein when the fastener engages but not secures the handle to the working channel, the handle is rotatable about a central longitudinal axis of the handle with respect to the working channel.

86. The medical injection device of claim 85, wherein when the fastener engages and secures the handle to the working channel, the handle is prevented from rotating about the central longitudinal axis of the handle with respect to the working channel.

87. The medical injection device of claim 83, wherein when the fastener is not engaged to the working channel, the fastener is freely rotatable about the handle.

88. The medical injection device of claim 83, wherein, prior to the fastener securing the handle to the working channel, the handle is rotatable about a central longitudinal axis of the handle with respect to the working channel.

89. The medical injection device of claim 83, wherein the handle further comprises at least one viewing window, andwherein, prior to the fastener securing the handle to the working channel, the at least one viewing window is rotatable about a central longitudinal axis of the handle with respect to the working channel to a user desired position.

90. The medical injection device of claim 83, wherein the fastener comprises a rotatable collar.113MEI 48657880v.

191. The medical injection device of claim 90, wherein the rotatable collar comprises interior threads configured to engage and secure the working channel to the handle.

92. The medical injection device of claim 83, wherein the fastener comprises an exterior body and an interior body.

93. The medical injection device of claim 83, wherein the fastener is connected to a tubular member of the plurality of tubular members, wherein a distal end of the tubular member is located at the distal end of the handle.

94. The medical injection device of claim 93, wherein the distal end of the tubular member is tapered to press fit with the working channel.

95. The medical injection device of claim 93, wherein the fastener comprises at least one support ridge configured to engage the tubular member when the working channel is attached to the medical injection device.

96. The medical injection device of claim 93, wherein the tubular member comprises an exterior body and an interior body shrouded by the exterior body.

97. The medical injection device of claim 96, wherein a distal end of the interior body of the tubular member is tapered to press fit with the working channel.

98. The medical injection device of claim 96, wherein the interior body of the tubular member and the exterior body of the tubular member are prevented from rotating with respect to114MEI 48657880v.1each other due to at least one flat portion of the interior body of the tubular member abutting at least one flat portion of the exterior body of the tubular member.

99. The medical injection device of claim 96, wherein the sheath is located axially within the interior body of the tubular member,wherein the sheath is configured to move axially through the interior body of the tubular member.

100. The medical injection device 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.

101. A medical injection device, comprising:a needle having a proximal end, a distal end, and a lumen configured to convey injection substance from the proximal end to the distal end;a 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;a first tubular member having a proximal end configured to attach to an injection substance supply and a distal end, wherein an inner portion of the first tubular member is attached to the proximal end of the needle;a second tubular member having a proximal end and a distal end, the proximal end located within the first tubular member, wherein an inner portion of the second tubular member is attached to the proximal end of the sheath, wherein the distal end of the first tubular member is configured to move along an exterior of the second tubular member; and115MEI 48657880v.1a third tubular member having a proximal end and a distal end, the proximal end located within the second tubular member, and the distal end configured to attach to a working channel, wherein the needle and the sheath extend from distal end of the third tubular member, wherein the distal end of the second tubular member is configured to move along an exterior of the third tubular member.

102. The medical injection device of claim 101, comprising a lock configured to prevent the needle from moving.

103. The medical injection device of claim 102, wherein the lock is configured to lock and unlock together the first tubular member and the second tubular member.

104. The medical injection device of claim 103, wherein the lock comprises a slide member attached to the first tubular member and configured to engage with teeth on the exterior of the second tubular member.

105. The medical injection device of claim 103, further comprising a second lock to lock the second tubular member with respect to a third tubular member; andwherein the lock and the second lock have different modes of operation.

106. The medical injection device of claim 102, wherein the lock is configured to communicate to a user a locked condition and an unlocked condition of the lock.

107. The medical injection device of claim 106, wherein when the lock is in a locked position, the needle is in a locked position and prevented from moving,116MEI 48657880v.1wherein when the lock is in an unlocked position, the needle is in an unlocked position and permitted to move,wherein the lock is configured to lock and unlock together the first tubular member and the second tubular member, andwherein the lock comprises a slide member attached to the first tubular member and configured to engage with teeth on the exterior of the second tubular member.

108. The medical injection device of claim 107, further comprising a second lock to lock the second tubular member with respect to a third tubular member, andwherein the lock and the second lock have different modes of operation.

109. The medical injection device of claim 102, wherein the lock is configured to tactilely communicate to a user a locked condition and an unlocked condition of the lock.

110. The medical injection device of claim 109, wherein when the lock is in a locked position, the needle is in a locked position and prevented from moving, a sharp surface of the lock is exposed, and a digit resting surface of the lock is not exposed, andwherein when the lock is in an unlocked position, the needle is in an unlocked position and permitted to move, the sharp surface of the lock is not exposed, and the digit resting surface of the lock is exposed.

111. The medical injection device of claim 102, wherein the lock is configured to communicate to a computer apparatus a locked condition and an unlocked condition of the lock.117MEI 48657880v.1112. The medical injection device of claim 111, wherein the lock comprises a slide member attached to the first tubular member and configured to engage with teeth on the exterior of the second tubular member, the slide member comprising a first portion configured to engage with and make an electrical connection with a second portion of teeth.

113. The medical injection device of claim 111, wherein when the lock is in a locked position, the needle is in a locked position and prevented from moving, and the first tubular member and the second tubular member are in electrical connection,wherein when the lock is in an unlocked position, the needle is in an unlocked position and permitted to move, and the first tubular member and the second tubular member are not in electrical connection.

114. The medical injection device of claim 101, comprising a fastener at the distal end of the third tubular member configured to secure the medical injection device to the working channel and to permit the third tubular member to rotate until the medical injection device is secured to the working channel.

115. The medical injection device of claim 114, wherein the third tubular member and the fastener are configured to rotate independently of each other about a central longitudinal axis of the third tubular member,wherein the second tubular member comprises a viewing window, andwherein, prior to the fastener securing the medical injection device to the working channel, the viewing window is rotatable about a central longitudinal axis of the second tubular member with respect to the working channel to a user desired position.118MEI 48657880v.1116. The medical injection device of claim 101, 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.

117. A method for injecting a substance into a subject, comprising:inserting a working channel into a subject;inserting a needle shrouded by a sheath into the working channel;attaching a handle to the working channel, the handle connected to the needle and the sheath, the handle comprising a plurality of nested tubular members, the plurality of nested tubular members comprising a first tubular member and a second tubular member;extending the sheath from a distal end of the working channel by operating the second tubular member of the plurality of nested tubular members;locking the sheath in position;extending the needle from a distal end of the sheath by operating the first tubular member of the plurality of nested tubular members;locking the needle in position; andinjecting the substance into the subject from the needle.

118. The method of claim 117, comprising operating a lock to lock the needle in position.

119. The method of claim 118, wherein the lock comprises:a first user communicative indicator when the needle is locked; and119MEI 48657880v.1a second user communicative indicator different from the first user communicative indicator when the needle is unlocked.

120. The method of claim 118, wherein the lock comprises:a first tactile indicator when the needle is unlocked; anda second tactile indicator different from the first tactile indicator when the needle is locked.

121. The method of claim 118, wherein the lock provides different signals to a computer apparatus in communication with the handle when the lock is in a locked position and in an unlocked position.

122. The method of claim 118, comprising, after the attaching step and before the extending step:rotating the handle with respect to the working channel to a user desired position; and securing the handle to the working channel with a fastener.

123. The method of claim 117, wherein the 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 8.120MEI 48657880v.1

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