Device for subcutaneous insertion of solid media

Abstract

Various embodiments include a device for subcutaneously inserting a solid medium. The device includes a handle having a central plane, a needle, and a guide. The needle is coupled to and extends from the handle. The needle has a needle longitudinal axis and a distal tip disposed along the needle longitudinal axis and the central plane. The guide extends from the handle. The guide has a distal end disposed along the central plane. The distal end of the guide is disposed further from the handle than the distal tip of the needle. The distal tip of the needle is visible when viewed along the central plane perpendicular to an axis including the distal end of the guide and the distal tip of the needle.

Description

Detailed Description of the Invention

[0001] [background] Current subcutaneous insertion devices for drug-eluting implants have the advantage of being reusable and simple, but they lack important needle safety features to prevent accidental needle sticks and reuse without proper cleaning and sterilization.

[0002] Additionally, many current insertion devices do not adequately control the depth of implant insertion, leading to implant migration or improper placement. With this in mind, some current subcutaneous insertion devices include depth guides. However, these depth guides are located directly above the needle during insertion, preventing the user from seeing the tip of the needle during use.

[0003] Additionally, many current devices are not preloaded and require the user to load the trocar needle with a solid medium. Because the needle is not preloaded in a sterile condition, these devices create a risk of contamination and infection. Current devices that are preloaded with a solid medium lack versatility because they can only be used with the preloaded agent specific to that implant.

[0004] Therefore, there is a need for an implant insertion device that is safe to use with minimal training, does not impede visibility of the needle during use, and can be used with a variety of solid media and implant forms. [overview] Various embodiments include a device for subcutaneously inserting a solid medium. The device includes a handle, a needle, and a guide. The handle has a central surface. The needle is coupled to and extends from the handle. The needle has a needle longitudinal axis and a distal tip disposed along the needle longitudinal axis and the central surface. The guide extends from the handle. The guide has a distal end disposed along the central surface. The distal end of the guide is disposed further from the handle than the distal tip of the needle. The distal tip of the needle is visible when viewed perpendicular to an axis including the distal end of the guide and the distal tip of the needle along the central surface.

[0005] In some embodiments, an axis including the distal end of the guide and the distal tip of the needle forms an approach angle with the needle longitudinal axis. In some embodiments, the approach angle is in the range of 5 to 50 degrees. In some embodiments, the approach angle is in the range of 5 to 30 degrees. In some embodiments, the approach angle is in the range of 5 to 15 degrees.

[0006] In some embodiments, the guide defines a window through which the distal tip of the needle is visible.

[0007] In some embodiments, the handle defines a cavity and the needle is retractable within the handle. In some embodiments, the needle is manually retractable. In some embodiments, the needle is retractable by spring force. In some embodiments, the handle includes a slider for moving the needle from the extended position to the retracted position. In some embodiments, the device further includes a plunger, the plunger axially aligned with the needle longitudinal axis to extend through the needle when the needle is retracted. In some embodiments, the needle is lockable in the retracted position. In some embodiments, the needle is lockable in the extended position.

[0008] In some embodiments, the handle has an hourglass shape when viewed parallel to the central plane.

[0009] In some embodiments, the edge of the distal end of the guide closest to the distal tip of the needle defines a fillet, chamfer, or smooth edge.

[0010] In some embodiments, the needle includes a first needle interface and the handle includes a second needle interface, the first needle interface of the needle being coupled to the second needle interface of the handle. In some embodiments, the needle and handle include a rotational clocking mechanism to ensure the rotational position of the needle relative to the handle. In some embodiments, the first needle interface is integrally formed with the needle. In some embodiments, the needle is preloaded with one or more pellets, rods, capsules, cylinders, spheres, implants, sensors, or any combination thereof.

[0011] In some embodiments, the guide includes at least one surface defining a plane extending parallel to the needle longitudinal axis, hi some embodiments, the combined width of the at least one surface is between 15 mm and 30 mm.

[0012] In some embodiments, the guide includes at least one surface that defines a plane extending parallel to the needle longitudinal axis, hi some embodiments, the combined width of the at least one surface is greater than or equal to three times the outer diameter of the needle.

[0013] In some embodiments, the guide includes a surface closest to the needle. In some embodiments, the distance from the surface of the guide to the needle is between 3 mm and 15 mm. In some embodiments, the distance from the surface of the guide to the needle is between 5 mm and 10 mm.

[0014] Various other embodiments include a device for subcutaneously inserting a solid medium. The device includes a handle and a guide. The handle has a central surface and a second needle interface for coupling with a first needle interface of the needle. The needle has a needle longitudinal axis and a distal tip disposed along the needle longitudinal axis. When the needle is coupled to the needle interface, the needle extends from the handle such that the distal tip of the needle is disposed along the central surface. The guide extends from the handle. The guide has a distal end disposed along the central surface.

[0015] In some embodiments, the handle includes a rotary clocking mechanism to ensure the rotational position of the needle relative to the handle.

[0016] In some embodiments, the handle has an hourglass shape when viewed parallel to the central plane.

[0017] In some embodiments, an axis including the distal end of the guide and the distal tip of the needle forms an approach angle with the needle longitudinal axis when the needle is coupled to the needle coupling portion of the handle. In some embodiments, the approach angle is in the range of 5 to 50 degrees. In some embodiments, the approach angle is in the range of 5 to 30 degrees. In some embodiments, the approach angle is in the range of 5 to 15 degrees.

[0018] In some embodiments, the handle defines a cavity, and the needle is retractable into the handle when the needle is coupled to the needle coupling of the handle. In some embodiments, the needle is manually retractable. In some embodiments, the needle is retractable by spring force. In some embodiments, the handle includes a slider for moving the needle from the extended position to the retracted position. In some embodiments, the handle includes a plunger, the plunger axially aligned with the needle longitudinal axis to extend through the needle when the needle is retracted. In some embodiments, the needle is lockable in the retracted position. In some embodiments, the needle is lockable in the extended position.

[0019] In some embodiments, when the needle is coupled to the needle interface of the handle, the edge of the distal end of the guide closest to the distal tip of the needle defines a fillet, chamfer, or smooth edge.

[0020] In some embodiments, the needle is pre-loaded with one or more pellets, rods, capsules, cylinders, spheres, implants, sensors, or any combination thereof.

[0021] In some embodiments, when the needle is coupled to the needle interface of the handle, the distal end of the guide is disposed further from the handle than the distal tip of the needle, and the distal tip of the needle is visible when viewed along a central plane perpendicular to an axis containing the distal end of the guide and the distal tip of the needle, hi some embodiments, the guide defines a window through which the distal tip of the needle is visible.

[0022] In some embodiments, the guide includes at least one surface that defines a plane that extends parallel to the needle longitudinal axis when the needle is coupled to the needle interface of the handle, hi some embodiments, the combined width of the at least one surface is between 15 mm and 35 mm.

[0023] In some embodiments, the guide includes at least one surface that defines a plane extending parallel to the needle longitudinal axis, hi some embodiments, the combined width of the at least one surface is greater than or equal to three times the outer diameter of the needle.

[0024] In some embodiments, the guide comprises a surface that is closest to the needle when the needle is coupled to the needle interface of the handle. In some embodiments, the distance from the surface of the guide to the needle is between 3 mm and 15 mm. In some embodiments, the distance from the surface of the guide to the needle is between 5 mm and 10 mm. [Brief description of the drawings]

[0025] Example features and embodiments are disclosed in the accompanying drawings. However, the disclosure is not limited to the precise arrangements and instrumentalities shown. [Figure 1] FIG. 1 is a perspective view of an apparatus for subcutaneously inserting a solid medium, according to one embodiment. [Figure 2A] FIG. 2A is a perspective view of the device of FIG. 1 with a needle coupled to a handle. [Figure 2B] FIG. 2B is a perspective view of the device of FIG. 1 with the needle detached from the handle. [Figure 3A] FIG. 3A is a left side view of the device of FIG. 1 with the needle detached from the handle. [Figure 3B] FIG. 3B is a left side view of the device of FIG. 1 with the needle connected to the handle. [Figure 3C] FIG. 3C is a right side view of the device of FIG. 1 with the needle connected to the handle. [Figure 4A] FIG. 4A is a top view of the device of FIG. 1 with a needle connected to a handle. [Figure 4B]FIG. 4B is a bottom view of the device of FIG. 1 with the needle connected to the handle. [Figure 5A] FIG. 5A is a partially exploded perspective view of the device of FIG. 1 in an extended position. [Figure 5B] 5B is a partially exploded perspective view of the device of FIG. 1 in a retracted position. [Figure 6A] FIG. 6A is a cross-sectional side view of coupling a needle to a device and retracting the needle of the device according to another embodiment. [Figure 6B] FIG. 6B is a cross-sectional side view of coupling a needle to a device and retracting the needle of the device according to another embodiment. [Figure 6C] FIG. 6C is a cross-sectional side view of coupling a needle to a device and retracting the needle of the device according to another embodiment. [Figure 6D] FIG. 6D is a cross-sectional side view of coupling a needle to a device and retracting the needle of the device according to another embodiment. [Figure 7] FIG. 7 is a perspective view of various needle and solid media sizes that can be used with the device of FIGS. 1-5B. [Figure 8] FIG. 8 is a top view of an apparatus according to another embodiment. [Figure 9] FIG. 9 is a perspective view of an apparatus and cassette according to another embodiment. [Figure 10] FIG. 10 is a perspective view of a needle according to another embodiment. [Figure 11] FIG. 11 is a perspective view of the device of FIG. [Figure 12] FIG. 12 is a side view of a device for subcutaneously inserting a solid medium, according to another embodiment. [Figure 13] FIG. 13 is a top view of the device of FIG. [Figure 14] FIG. 14 is a perspective view of the device of FIG. [Figure 15] FIG. 15 is another perspective view of the device of FIG. [Figure 16] FIG. 16 is a side view of a device for subcutaneously inserting a solid medium, according to another embodiment. [Figure 17]FIG. 17 is a top view of the device of FIG. 16 with the needle connected to the handle. [Figure 18] FIG. 18 is a top view of the needle of FIG. 17 shown without the device. [Figure 19] FIG. 19 is a rear perspective view of the device of FIG. 16 with the needle connected to the handle. [Figure 20] FIG. 20 is a rear perspective view of the device of FIG. 19 with the needle detached from the handle. [Figure 21] FIG. 21 is a front perspective view of the device of FIG. 16 with the needle connected to the handle. [Figure 22] FIG. 22 is a front perspective view of the device of FIG. 19 with the needle detached from the handle. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0026] The devices, systems, and methods disclosed herein provide for subcutaneous insertion of solid media. The devices disclosed herein can be used to insert biodegradable or non-biodegradable solid drug dosage forms, particularly drug pellets or rod-shaped implants, subcutaneously into humans or animals, and are particularly easy to use, ready to use, ergonomic, safe, and designed for use by minimally trained entry-level medical personnel in busy clinical settings.

[0027] Some embodiments of the device include a guide to control the depth and angle of needle insertion into the patient. The guide includes a window or other structure to allow the user to view the distal tip of the needle through the guide as the needle is inserted into the patient. Some embodiments of the device also include a needle interface to which a needle can be coupled. This allows for a versatile device that can be coupled to needles of various sizes and diameters that are preloaded with a desired solid medium.

[0028] Various embodiments include a device for subcutaneously inserting a solid medium. The device includes a handle having a central plane, a needle, and a guide. The needle is coupled to and extends from the handle. The needle has a needle longitudinal axis and a distal tip disposed along the needle longitudinal axis and the central plane. The guide extends from the handle. The guide has a distal end disposed along a central plane. The distal end of the guide is disposed further from the handle than the distal tip of the needle. The distal tip of the needle is visible when viewed perpendicular to an axis including the distal end of the guide and the distal tip of the needle along the central plane.

[0029] Various other embodiments include a device for subcutaneously inserting a solid medium. The device includes a handle and a guide. The handle has a central surface and a needle interface for coupling a needle. The needle has a needle longitudinal axis and a distal tip disposed along the needle longitudinal axis. When the needle is coupled to the needle interface, the needle extends from the handle and the distal tip of the needle is disposed along the central surface. The guide extends from the handle and has a distal end disposed along the central surface.

[0030] 1-5B show a device 100 for subcutaneously inserting a solid medium, according to one embodiment. The device 100 includes a handle 110, a needle 160, and a guide 170.

[0031] The handle 110 has a central surface 112 and includes a handle body 120 defining a cavity 122. An outer surface 124 of the handle body 120 defines two concave gripping portions 126 located on opposite sides of the central surface 112. A user may place portions of their hands within the gripping portions 126 to prevent hand slippage while using the device 100.

[0032] 1-5B has concave features, in other embodiments the gripping portion is convex, flat, or any combination of concave, convex, and / or flat features. In some embodiments, the gripping portion comprises a textured surface or a frictional coating or material.

[0033] 12-15, the body 620 of the handle 610 may have an hourglass shaped portion when viewed from the top of the handle 610 in a direction parallel to the central plane 612. The hourglass shape of the body 620 of the handle 612 provides an affordance for pushing and pulling during insertion and retraction of the needle 660.

[0034] As shown in FIGS. 1 to 5B, the handle 110 includes a retractor 130 disposed within a cavity 122 of the handle body 120. The retractor 130 includes a pull rod 132 that is slidable along its longitudinal axis 139 relative to the handle body 120, a plunger 140 that is disposed parallel to the longitudinal axis 139 of the pull rod 132 and is static relative to the handle body 120, and needle couplings 142, 143. The needle coupling includes a first needle coupling 142 that is a part of the needle 160 and a second needle coupling 143 that is a part of the retractor 130 of the handle 110. The plunger 140 and the second needle coupling 143 of the retractor 130 are disposed along the central plane 112 of the handle 110, so that when the first needle coupling 142 of the needle 160 is coupled to the second needle coupling 143 of the retractor 130, the needle 160 is also disposed along the central plane 112. The second needle coupling 143 defines an opening 144, and the plunger 140 is disposed within the opening 144 of the second needle coupling 143 such that the second needle coupling 143 is slidable along the plunger 140. The pull rod 132 has a first end 134 and a second end 136 opposite the first end 134. The first end 134 of the pull rod 132 is provided with a pull knob 138, and the second end 136 of the pull rod 132 is coupled to the second needle coupling 143.

[0035] When a user applies a force to the first end 134 of the pull rod 132 in a direction away from the handle body 120, the pull rod 132 extends outward from the handle body 120. Because the second needle coupling 143 is coupled to the second end 136 of the pull rod 132, the second needle coupling 143 slides along the plunger 140 in the same direction as the pull rod 132. When the first needle coupling 142 of the needle 160 is coupled to the second needle coupling 143, the movement of the second needle coupling 143 moves the needle 160 from an extended position shown in FIG. 5A where at least a portion of the needle 160 extends outside the cavity 122 of the handle body 120, to a retracted position shown in FIG. 5B where the needle 160 is disposed within the cavity 122 of the handle body 120, as described below.

[0036] While the first end 134 of the pull rod 132 shown in Figures 1-5B includes a pull knob 138, in other embodiments, the pull rod includes a handle, loop, or other feature that allows a user to grip the first end of the pull rod when applying force to the pull rod. In some embodiments, such as the device shown in Figures 6A-6D and 12-22, the retractor 230, 630, 730 includes a slider 238, 638, 738 directly coupled to the second needle coupling 243, 643, 743, so that as the slider 238, 638, 738 slides, the second needle coupling 243, 643, 743 and the needle 260, 660, 760 are retracted. In some embodiments, the first end of the pull rod does not include a pull knob or other mechanism.

[0037] In some embodiments, such as device 700 shown in Figures 16-22, the needle further includes a retractor 730 having a sliding tab 745 and a plunger 740. The sliding tab 745 is coupled to a needle 760, which is slidable along the plunger 740, similar to the retractors described above. The first needle connector 742 is a body that is removably connectable to a second needle connector 743. When the first needle connector 742 is coupled to the second needle connector 743, the sliding tab 745 engages the slider 738 such that movement of the slider 738 moves the sliding tab 745 and the needle 760 from the extended position to the retracted position.

[0038] In some embodiments, the retractor includes a spring that exerts a force away from the handle body to move the needle interface from the extended position to the retracted position, and the retractor further includes a trigger that holds the spring in tension until a user actuates the trigger to release the spring force and move the needle interface.

[0039] 11 , the retractor 530 further includes a lock 550 that prevents the needle 560 from being inadvertently retracted into the handle body 520 when coupling the needle 560 to the handle 510 or when positioning the needle 560 for insertion into the skin. The lock 550 can be released by retracting the pull rod 532 of the retractor 530 of the device 500, allowing the needle 560 to be retracted into the handle body 520.

[0040] The needle coupling portions 143, 143 each include a rotational clocking mechanism that interacts when the needle coupling portions 143, 143 are coupled to one another to ensure that the distal tip 166 of the needle 160 is rotationally oriented correctly to achieve the proper angle of entry.

[0041] Although the needle connectors 142, 143 shown in Figures 1-5B include luer lock connectors for coupling a needle 160 having a corresponding luer lock connector, in other embodiments, the needle connectors can include various snap connections, bayonet connections, or other types of connectors capable of coupling a needle to a retractor. For example, the embodiment shown in Figures 6A-6D includes a first needle connector 242 and a second needle connector 243. The first needle connector 242 includes a latch arm 242a, and the second needle connector 243 defines a receiving opening 243a configured to receive a portion of the latch arm 242a. The first needle connector 242 is insertable into a portion of the opening 244 of the second needle connector 243 such that a portion of the latch arm 242a couples with the receiving opening 243a. Coupling a portion of latch arm 242a to receiving opening 243a ensures that distal tip 266 of needle 260 is rotationally oriented to achieve the proper entry angle.

[0042] The needle 160 shown in Figures 1-5B is a trocar needle. The needle 160 has a longitudinal axis 162, a connecting end 164, and a distal tip 166 spaced apart from the connecting end 164 along the longitudinal axis 162. As shown in Figures 1-5B, the first needle coupling 142 of the needle 160 is connectable to the second needle coupling 143 of the handle 110 such that the plunger 140 is aligned with the longitudinal axis 162 of the needle 160 and the distal tip 166 of the needle 160 is disposed along the central plane 112.

[0043] 1-5B includes a first needle coupling 142 attached to the needle 160, but in other embodiments, such as the needle 460 shown in FIG. 10, the needle includes an integral first needle coupling defined by the needle 460 itself. The connecting end 464 defines two openings 465 for engaging and coupling with a second needle coupling. The connecting end 464 of the needle 460 also defines a groove 463 for engaging with a protrusion on the second needle coupling to rotate and clock the needle couplings relative to one another, ensuring that the distal tip 466 of the needle 460 is rotationally oriented to achieve the proper entry angle.

[0044] 1-5B is preloaded with one or more medicament pellets disposed within the needle lumen before the needle 160 is coupled to the needle coupling 142 of the retractor 130 of the handle 110. However, in some embodiments, the needle is preloaded with a rod, cylinder, sphere, capsule, or other size or shape of solid medium for subcutaneous insertion, and the needle is sized for the size and shape of the medicament.

[0045] In some embodiments, the pellet, rod, cylinder, sphere, capsule, container, or other inserted element is not a drug, but rather a device or implant, such as a tracker, sensor, microchip, or other type of digital medium.

[0046] As shown in Figure 7, in some embodiments, the device is configured to couple to needles of various lengths and diameters. Although the needles shown in Figure 7 vary in diameter and length, the first needle connector is the same size, allowing the first needle connector of any length or diameter to be coupled to a universally sized second needle connector. The different needle lengths and diameters allow the same device to be used with a variety of sizes of solid insertion media.

[0047] FIG. 9 illustrates another embodiment of the device 300. The device 300 is similar to other devices disclosed herein, but the device 300 illustrated in FIG. 9 includes a pre-loaded needle cassette 331 including a retractor 330 and a needle 360 ​​permanently coupled to the retractor 330. The cassette is insertable and coupleable to the handle body 320 of the handle 310. The size and shape of the cassette 331 is universal, allowing the cassette 331 with various sizes of needles 360 to be used with the universal handle 310. A portion of the cassette has an oval cross-sectional shape when viewed in a plane perpendicular to the longitudinal axis 362 of the needle 360, allowing the distal tip 366 of the needle 360 ​​to be rotated and clocked into position relative to the guide 370 to ensure the proper entry angle. The cassette contains all internal elements, which are kept sterile prior to and during the workflow. The internal elements of the cassette can also be optimally sized to accommodate the load of solid media contained within the needles of the cassette.

[0048] In some embodiments, such as device 600 shown in Figures 12-15, the needle is permanently connected to the needle connector of the handle and may be pre-loaded with a solid medium, thus in these embodiments the point-of-care user does not need to connect the needle to the handle prior to use.

[0049] Guide 170 is coupled to handle 110 and extends along a longitudinal axis 172 that is parallel to needle longitudinal axis 162. Guide 170 has a proximal end 174 coupled to handle 110 and a distal end 176 opposite and spaced apart from proximal end 174. Distal end 174 of guide 170 is disposed along central plane 112.

[0050] The distal end 176 of the guide 170 is positioned farther from the handle 110 than the distal tip 166 of the needle 160 when the needle 160 is in the extended position. The length of the guide 170 and the length of the needle 160 shown in FIGS. 1-5B are sized such that an axis 178 including the distal end 176 of the guide 170 and the distal tip 166 of the needle 160 forms a 30 degree approach angle 180 with the needle longitudinal axis 162. Thus, when using the device 100, a user can determine a desired needle 160 approach angle of 30 degrees by positioning the distal end 176 of the guide 170 and the distal tip 166 of the needle 160 on the patient's skin. While the approach angle 180 of the device 100 shown in FIGS. 1-5B is 30 degrees, in other embodiments the approach angle is any angle in the range of 5-50 degrees, such as 20-40 degrees. In some embodiments the approach angle is any angle in the range of 5-15 degrees. In some embodiments, the approach angle is any angle less than or equal to 15 degrees. In some embodiments, the approach angle is any angle less than or equal to 10 degrees. The first and second needle connections 142, 143 ensure the correct length of the needle 160 relative to the guide 170 to establish the desired approach angle 180, as well as provide a secure and stable connection of the needle 160 to the handle 110, thereby minimizing angular deflection along the cantilever needle 160.

[0051] The guide 170 has a first surface 182 and a second surface 184 opposite the first surface 182. The second surface 184 of the guide 170 is closer to the needle 160 than the first surface 182. The guide 170 shown in FIGS. 1-5B further defines a window 190 extending from the first surface 182 to the second surface 184, through which the distal tip 166 of the needle 160 is visible when viewing the needle 160 along the central axis 112 from the first surface 182 toward the second surface 184. Thus, a user can view the distal tip 166 of the needle 160 through the guide 170 from the top of the device 100 while inserting the needle 160 into a patient.

[0052] 1-5B defines a window 190, it should be understood that in other embodiments, the guide can have any shape that allows the distal tip of the needle to be viewed along a central plane, perpendicular to an axis that includes the distal end of the guide and the distal tip of the needle, including a distal end of the guide that can be used to set the angle of entry, such as a forked or curved guide. Also, in some embodiments, the guide is made of a transparent or translucent material so that the distal tip of the needle can be viewed through the guide.

[0053] 1-5B, the edge where the second surface 184 and distal end 176 of the guide 170 intersect defines a fillet 186 for guiding the angle of the needle 160 during insertion. However, in other embodiments, the edge between the second surface and the distal end of the guide includes a chamfer, bevel, or other smooth edge that can guide the angle of the needle during insertion.

[0054] The second surface 184 of the guide 170 defines a plane extending parallel to the needle longitudinal axis 162 and has an overall width 192 measured across the second surface 184 of 15 mm. The width 192 of the second surface 184 of the guide 170 provides stability to the device 100 during insertion of the needle 160 and prevents the device 100 from undesired rotation during use. The overall width 192 of the second surface 184 of the device 100 shown in Figures 1-5B is 15 mm, however, in some embodiments, the width of the second surface ranges from 15 mm to 30 mm. In some embodiments, the width of the second surface is 15 mm or more. In some embodiments, the width of the second surface is 3 to 5 times the outer diameter of the needle. In some embodiments, the width of the second surface is 3 times the outer diameter of the needle or more.

[0055] 1-5B, the distance 194 from the second surface 184 of the guide 170 to the needle 160 of the device 100 is between 3 mm and 15 mm, preferably between 5 mm and 10 mm, depending on the typical thickness of skin at the intended body site. However, in other embodiments, the distance between the second surface of the guide and the needle is any distance selected based on the desired depth of needle insertion.

[0056] 6A-6D, in use, the user slides the needle 260 into the opening 244 such that the first needle connector 242 of the needle 260 connects to the second needle connector 243 of the retractor 230, as shown in FIGS. 6A and 6B. The user abuts the distal tip 266 of the needle 260 and the distal end 276 of the guide 270 against the patient's skin to establish an angle of entry 280. The user then applies force to the handle 210 of the device 200 to pierce the needle 260 into the skin. By keeping the guide 270 in contact with the patient's skin, the insertion angle of the needle 260 rotates about the fillet 286 on the edge of the guide 270, limiting the depth of insertion of the needle 260 into the patient. When the second surface 284 of the guide 270 contacts the patient's skin and the device 200 is rotated so that the needle 260 is approximately parallel to the surface of the skin, the needle 260 is fully inserted under the skin. The user then activates the lock 250, for example, by applying sufficient force to the slider of the retractor 230 to depress the slider past the lock 250, allowing the slider and second needle coupling to retract into the handle 210, as shown in FIG. 6C. The retractor 230 is then activated, either manually by sliding the slider 238 and pulling the pull knob, or automatically by activating a trigger, to move the needle 260 from the extended position to the retracted position, as shown in FIG. 6D. Moving the needle 260 from the extended position to the retracted position removes the needle 260 from beneath the patient's skin into the cavity 222 of the handle body 220, and the distal tip 266 of the needle 260 is no longer exposed. The device may also include a second lock 261, such as the barbed lock shown in FIGS. 6A-6D, to prevent the needle 260 from moving back from the retracted position to the extended position.

[0057] The plunger 240 of the retractor 230 is statically coupled to the handle body 220 and aligned with the needle 260, so that when the needle 260 is moved from the extended position to the retracted position, the plunger 240 extends through the lumen of the needle 260, as shown in FIG. 6D. As the needle 260 is being retracted, the plunger 240 remains stationary relative to the handle body 220, so that any solid media disposed within the lumen of the needle 260 contacts the end of the plunger 240 and is prevented from being retracted along with the needle 260, leaving the solid media under the patient's skin. With the needle 260 retracted within the cavity 222 of the handle body 220, no part of the device 200 should be further withdrawn from the patent.

[0058] Here, some example embodiments are provided. However, it is understood that various modifications can be made without departing from the spirit and scope of the disclosure of this specification. As used in this specification and the appended claims, the singular forms "a", "an" and "the" include plural referents unless the context clearly dictates otherwise. As used herein, the term "comprising" and variations thereof are used synonymously with the term "including" and variations thereof, and are open and non-limiting terms. Although the terms "comprising" and "including" are used herein to describe various embodiments, more specific embodiments can also be provided and are disclosed by using the terms "consisting essentially of" and "consisting of" instead of "comprising" and "including."

[0059] Disclosed are materials, systems, devices, methods, compositions, and components that can be used in, can be used in conjunction with, can be used in preparation for, or are products of the disclosed methods, systems, and devices. These and other components are disclosed herein, and where combinations, subsets, interactions, groups, etc. of these components are disclosed, it is understood that each is specifically contemplated and described herein, although specific reference to the various individual and collective combinations and permutations of these components may not be expressly disclosed. For example, where a device is disclosed and described, all combinations and permutations of the device and possible variations are specifically contemplated, unless specifically indicated to the contrary. Likewise, subsets or combinations of these are also specifically contemplated and disclosed. This concept applies to all aspects of the disclosure, including, but not limited to, method steps using the disclosed systems or devices. Thus, where there are various additional steps that can be performed, it is understood that each of these additional steps can be performed with any particular method step or combination of method steps of the disclosed methods, and that each such combination or subset of combinations should be considered to be specifically contemplated and disclosed.

Claims

1. 1. A device for subcutaneously inserting a solid medium, the device comprising: a handle having a central surface; a needle coupled to and extending from the handle, the needle having a needle longitudinal axis and a distal tip disposed along the needle longitudinal axis and the central plane; a guide extending from the handle, the guide having a distal end disposed along the central plane; the distal end of the guide is disposed further from the handle than the distal tip of the needle; A device wherein the distal tip of the needle is visible when viewed along the central plane perpendicular to an axis containing the distal end of the guide and the distal tip of the needle.

2. The device of claim 1 , wherein an axis including the distal end of the guide and the distal tip of the needle forms an approach angle with the needle longitudinal axis, the approach angle being in the range of 5 to 50 degrees.

3. The apparatus of claim 2, wherein the approach angle is in the range of 5 to 30 degrees.

4. The apparatus of claim 3, wherein the approach angle is in the range of 5 to 15 degrees.

5. The device of claim 1 , wherein the guide defines a window through which the distal tip of the needle is visible.

6. The device of claim 1 , wherein the handle defines a cavity and the needle is retractable within the handle.

7. The device of claim 6 , wherein the needle is manually retractable.

8. The device of claim 6 , wherein the needle is retractable by a spring force.

9. The device of claim 6 , wherein the handle includes a slider for moving the needle from an extended position to a retracted position.

10. 7. The device of claim 6, further comprising a plunger, the plunger being axially aligned with the needle longitudinal axis so as to extend through the needle when the needle is retracted.

11. The device of claim 6 , wherein the needle is lockable in a retracted position.

12. The device of claim 6 , wherein the needle is lockable in the extended position.

13. The device of claim 1 , wherein the handle has an hourglass shape when viewed parallel to the central plane.

14. The device of claim 1 , wherein an edge of the distal end of the guide closest to the distal tip of the needle defines a fillet, chamfer, or smooth edge.

15. 2. The device of claim 1, wherein the needle includes a first needle connector and the handle includes a second needle connector, the first needle connector of the needle being connected to the second needle connector of the handle.

16. 16. The device of claim 15, wherein the needle and the handle include a rotational clocking mechanism for ensuring the rotational position of the needle relative to the handle.

17. The device of claim 15 , wherein the first needle connector is integrally formed with the needle.

18. 16. The device of claim 15, wherein the needle is pre-loaded with one or more pellets, rods, capsules, cylinders, spheres, implants, sensors, or any combination thereof.

19. The device of claim 1 , wherein the guide includes at least one surface defining a plane extending parallel to the needle longitudinal axis, the at least one surface having a combined width of between 15 mm and 30 mm.

20. 2. The device of claim 1, wherein the guide includes at least one surface defining a plane extending parallel to the needle longitudinal axis, the combined width of the at least one surface being greater than or equal to three times the outer diameter of the needle.

21. The device of claim 1 , wherein the guide includes a surface closest to the needle, and the distance from the surface of the guide to the needle is between 3 mm and 15 mm.

22. 22. The device of claim 21, wherein the distance from the surface of the guide to the needle is between 5 mm and 10 mm.

23. 1. A device for subcutaneously inserting a solid medium, comprising: a handle having a central plane and a second needle interface for connecting with a first needle interface of a needle having a needle longitudinal axis and a distal tip disposed along the needle longitudinal axis, the needle extending from the handle when the needle is connected to the needle interface such that the distal tip of the needle is disposed along the central plane; a guide extending from the handle, the guide having a distal end disposed along the central plane.

24. 24. The device of claim 23, wherein the handle includes a rotary clocking mechanism for securing the rotational position of the needle relative to the handle.

25. 24. The device of claim 23, wherein the handle has an hourglass shape when viewed parallel to the central plane.

26. 24. The device of claim 23, wherein an axis including the distal end of the guide and the distal tip of the needle forms an approach angle with the needle longitudinal axis when the needle is coupled to the needle coupling portion of the handle, the approach angle being in the range of 5 to 50 degrees.

27. 27. The apparatus of claim 26, wherein the approach angle is in the range of 5 to 30 degrees.

28. 28. The apparatus of claim 27, wherein the approach angle is in the range of 5 to 15 degrees.

29. 24. The device of claim 23, wherein the handle defines a cavity, and the needle is retractable into the handle when the needle is coupled to the needle interface of the handle.

30. 30. The device of claim 29, wherein the needle is manually retractable.

31. 30. The device of claim 29, wherein the needle is retractable by a spring force.

32. 30. The device of claim 29, wherein the handle includes a slider for moving the needle from an extended position to a retracted position.

33. 30. The device of claim 29, wherein the handle includes a plunger that is axially aligned with the needle longitudinal axis to extend through the needle when the needle is retracted.

34. 30. The device of claim 29, wherein the needle is lockable in a retracted position.

35. 30. The device of claim 29, wherein the needle is lockable in the extended position.

36. 24. The device of claim 23, wherein an edge of the distal end of the guide closest to the distal tip of the needle defines a fillet, chamfer, or smooth edge when the needle is coupled to the needle interface of the handle.

37. 24. The device of claim 23, wherein the needle is pre-loaded with one or more pellets, rods, capsules, cylinders, spheres, implants, sensors, or any combination thereof.

38. 24. The device of claim 23, wherein when the needle is coupled to the needle interface of the handle, the distal end of the guide is positioned farther from the handle than the distal tip of the needle, and the distal tip of the needle is visible when viewed along the central plane perpendicular to an axis containing the distal end of the guide and the distal tip of the needle.

39. 40. The apparatus of claim 38, wherein the guide defines a window through which the distal tip of the needle is visible.

40. 24. The device of claim 23, wherein the guide includes at least one surface defining a plane extending parallel to the needle longitudinal axis when the needle is coupled to the needle coupling portion of the handle, and wherein a combined width of the at least one surface is between 15 mm and 35 mm.

41. 24. The device of claim 23, wherein the guide includes at least one surface defining a plane extending parallel to the needle longitudinal axis, the combined width of the at least one surface being greater than or equal to three times the outer diameter of the needle.

42. 24. The device of claim 23, wherein the guide includes a surface that is closest to the needle when the needle is connected to the needle interface of the handle, and the distance from the surface of the guide to the needle is between 3 mm and 15 mm.

43. 43. The apparatus of claim 42, wherein the distance from the surface of the guide to the needle is between 5 mm and 10 mm.

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