Needle and Housing

Abstract

The inserter assembly (100) has a base (104), a needle (204), an inner part (206) for selectively transitioning the needle from a retracted position substantially within the base to an extended position in which at least a portion of the needle extends outside the base, and an insertion angle component. As the inner part of the inserter assembly transitions from the retracted position to the extended position, the needle is at least partially deflected by the insertion angle component.

Description

[Technical field]

[0001] FIELD OF THE DISCLOSURE The present disclosure relates to mechanisms for inserting a needle, and more particularly, to mechanisms for deforming a needle as part of the insertion process. [Background technology]

[0002] The inserter mechanism is often used to facilitate the insertion of the needle and / or cannula into the user and further to distribute or remove fluids from the user's body. Typically, the needle is positioned within the inserter mechanism in a retracted position and has a generally linear dimension. When the inserter is actuated, the needle extends axially into the user's soft tissue along the needle's longitudinal axis. The inserted needle or cannula typically remains within the user's body for a period of time. Thus, after the needle and / or cannula is inserted, the bulky insertion mechanism is often removed to reduce the size and weight of the device in use. After the needle and / or cannula is inserted into the user, it is often fluidly coupled to a fluid delivery or retention device. Summary of the Invention [Means for solving the problem]

[0003] One embodiment is an inserter assembly having a base, a needle, an inner component configured to selectively transition the needle from a retracted position substantially within the base to an extended position in which at least a portion of the needle extends outside the base, and an insertion angle component, in which the needle is at least partially deflected by the insertion angle component as the inner component transitions from the retracted position to the extended position.

[0004] In one example of this embodiment, the inner component rotates about the axis of rotation to transition the needle from the retracted position to the extended position. In another example, the inner component is rotatably coupled to the base about the axis of rotation. As part of this example, the inner component is coupled to the needle, such that rotation of the inner component about the axis of rotation moves the needle about the axis of rotation.

[0005] In other examples of this embodiment, the needle is elastically deformable to fit within the base and deflects through contact with the insertion angle component as the needle transitions from a retracted position to an extended position, in some examples of this, the needle maintains a substantially straight shape as it extends outside the base.

[0006] Yet another example includes a base fluid channel partially defined in the base. This example further includes an inner fluid channel defined in the inner piece, the base fluid channel fluidically coupled to the inner fluid channel. Additionally, the inner fluid channel is fluidically coupled to the needle fluid channel, such that fluid from the base fluid channel is partially directed through the inner fluid channel of the inner piece and into the needle fluid channel of the needle, regardless of the angle of rotation of the inner piece relative to the base about the axis of rotation. In another portion of this example, the base fluid channel is fluidically coupled to the inner fluid channel at least partially along the axis of rotation. One aspect of this portion further includes a circular seal positioned between the inner piece and the base to fluidically seal the transition between the base fluid channel and the inner fluid channel, regardless of the angular orientation of the inner piece relative to the base about the axis of rotation.

[0007] Yet another example of this embodiment has an upper assembly selectable to transition the needle from a retracted position to an extended position. As part of this example, the upper assembly has a driver, a lid, a release mechanism, and a spring positioned therebetween. When the upper assembly is coupled to the inserter assembly, the driver is rotatably secured to the inner component. Additionally, the upper assembly is removable from the base and the inner component. In another aspect of this example, the upper assembly has a load-loaded configuration, where the spring applies a rotational bias to the driver relative to the lid, and when the release mechanism is released, the driver rotates relative to the lid about a rotational axis, thereby rotating the inner component and transitioning the needle from a retracted position to an extended position.

[0008] In another example of this embodiment, the needle is configured to deliver fluid from the base fluid channel to the distal tip of the needle when in the extended position, hi yet another example, the base defines a base fluid channel fluidly coupled to the needle for supplying fluid, the base fluid channel configured to be fluidly coupled to a fluid delivery device.

[0009] In yet another example of this embodiment, the insertion angle component is removable from the base. In some examples of this embodiment, a number of different insertion angle components are coupleable to the base to provide selectable insertion angles of the needle in the extended position based on the particular insertion angle component coupled to the base.

[0010] In another example of this embodiment, the insertion angle component is movable to change the insertion angle of the needle in the extended position. In another example, the inner part rotates about an axis of rotation to retract the needle from the extended position to the retracted position. In yet another example, the degree of rotation of the inner part relative to the base is variable to change the insertion depth of the needle in the extended position.

[0011] In one example of this embodiment, the insertion angle component tilts the needle at an angle of about 30 degrees relative to the surface of the base. Some of this example include a filter in one or more of the base fluid channel, the inner fluid channel, and the needle fluid channel.

[0012] In another example, in the extended position, the needle extends from the base by about 3-4 millimeters. In yet another example, a rotational actuator rotates the inner component relative to the base to transition the needle from the retracted position to the extended position. In some of these examples, the rotational actuator is coupled to a gear to rotate the inner component.

[0013] Another example of this embodiment includes a second needle coupled to the inner component, where transitioning the inserter assembly from the retracted position to the extended position causes at least a portion of the second needle to extend outside the base.

[0014] Another embodiment of the present disclosure is an inserter assembly having a base that houses a needle and an inserter, the needle being repositionable between a retracted position and an extended position by the inserter, in which at least a portion of the needle has an arcuate orientation in the retracted position and a generally linear orientation in the extended position.

[0015] In one example of this embodiment, the inserter includes an inner part that rotates about an axis of rotation to transition the needle from a retracted position to an extended position. As part of this example, the inner part is rotatably coupled to the base about the axis of rotation. Further, the inner part is coupled to the needle such that rotation of the inner part about the axis of rotation moves the needle about the axis of rotation.

[0016] In another example of this embodiment, the needle is resiliently deformable to fit within the base and deflect as the needle transitions from the retracted position to the extended position. As part of this example, the needle maintains a generally straight shape as it extends outside the base.

[0017] Another example of this embodiment has a base fluid channel partially defined in the base. A portion of this example includes an inner fluid channel defined in the inner piece, where the base fluid channel is fluidically coupled to the inner fluid channel. In another portion of this example, the inner fluid channel is fluidically coupled to the needle fluid channel, whereby fluid from the base fluid channel is partially directed through the inner fluid channel of the inner piece and into the needle fluid channel of the needle, regardless of the angle of rotation of the inner piece relative to the base about the axis of rotation. Additionally, the base fluid channel is fluidically coupled to the inner fluid channel at least partially along the axis of rotation. This example may include a circular seal positioned between the inner piece and the base to fluidically seal the transition between the base fluid channel and the inner fluid channel, regardless of the angular orientation of the inner piece relative to the base about the axis of rotation.

[0018] Yet another example of this embodiment includes an upper assembly selectable to transition the needle from a retracted position to an extended position. In some of these examples, the upper assembly includes a driver, a lid, a release mechanism, and a spring disposed therebetween. In other parts of these examples, when the upper assembly is coupled to the inserter assembly, the driver is rotatably secured to the inner component. In this configuration, the upper assembly is removable from the base and the inner component. In some of these examples, the upper assembly has a load-loaded configuration, where the spring applies a rotational bias to the driver relative to the lid, and when the release mechanism is released, the driver rotates relative to the lid about a rotational axis, thereby rotating the inner component and transitioning the needle from the retracted position to the extended position.

[0019] In yet another example of this embodiment, the needle is configured to deliver fluid from the base fluid channel to the distal tip of the needle when in the extended position, hi one example, the base defines a base fluid channel fluidly coupled to the needle for supplying fluid, the base fluid channel configured to be fluidly coupled to a fluid delivery device.

[0020] In other examples, the insertion angle component is removable from the base. In some of these examples, a number of different insertion angle components are coupleable to the base to provide selectable insertion angles of the needle in the extended position based on the particular insertion angle component coupled to the base.

[0021] Yet another example of this embodiment includes an insertion angle component that is movable to change the insertion angle of the needle in the extended position.

[0022] Other examples include an inner part that rotates about an axis of rotation to retract the needle from an extended position to a retracted position, in some of these examples the degree of rotation of the inner part relative to the base is variable to change the insertion depth of the needle in the extended position.

[0023] Yet another example of this embodiment includes an insertion angle component that tilts the needle at an angle of about 30 degrees relative to the surface of the base. Another example has a filter positioned to filter fluid entering the needle. In another example, in the extended position, the needle extends about 3 to 4 millimeters from the base.

[0024] Another example includes a rotary actuator that transitions the needle from a retracted position to an extended position. In some of these examples, the rotary actuator is coupled to a gear.

[0025] Another example of this embodiment includes a second needle, where transitioning from the retracted position to the extended position causes at least a portion of the second needle to extend outside the base. [Brief description of the drawings]

[0026] The above-mentioned aspects of the present disclosure and the manner of obtaining them will become more apparent, and the disclosure itself will be better understood, by reference to the following description of embodiments of the disclosure in conjunction with the accompanying drawings, in which:

[0027] [Figure 1] FIG. 1 illustrates a top perspective view of one embodiment of an inserter assembly. [Diagram 2] FIG. 2 is an enlarged view of the inserter assembly of FIG. 1. [Figure 3a] FIG. 2 is a cross-sectional view of the inserter assembly of FIG. 1. [Figure 3b] 2 is another cross-sectional view of the inserter assembly of FIG. 1. [Figure 4] FIG. 2 is a side view of the inserter assembly of FIG. 1 in an extended position. [Diagram 5] FIG. 13 is a top perspective view of another embodiment of an insertion device having a movable insertion angle component. [Figure 6] FIG. 2 is a top perspective view of the inserter assembly of FIG. 1 with the upper assembly partially removed. [Figure 7] 2 is another cross-sectional view of the inserter assembly of FIG. 1. [Figure 8a] FIG. 13 is a top close-up view of another embodiment of the inserter assembly. [Figure 8b] FIG. 8b is a top view of a portion of the inserter assembly of FIG. 8a. [Figure 9] 1 illustrates one embodiment of an inserter assembly having an activator for transitioning the needle from an extended position to a retracted position. [Figure 10a] 13 illustrates another embodiment of an inserter assembly having two needles. [Figure 10b] 13 illustrates another embodiment of an inserter assembly having two needles.

[0028] Corresponding reference numerals are used to indicate corresponding parts throughout the several views. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0029] The embodiments of the present disclosure described below are not intended to be exhaustive or to limit the present disclosure to the precise forms set forth in the following detailed description, but rather the embodiments are chosen and described so that others skilled in the art can appreciate and understand the principles and practices of the present disclosure.

[0030] 1, one embodiment of an inserter assembly 100 is shown. The inserter assembly 100 can have an upper assembly 102 selectively coupleable to a base 104. The upper assembly 102 can have a lid 106 and a release mechanism 108, among other components that will be described in more detail herein. The base 104 can be configured to be coupled to a user via an adhesive or the like such that a needle 204 (see FIG. 2) can be selectively positioned within the user's soft tissue.

[0031] 2, an exploded view of the components of the inserter assembly 100 is shown. More specifically, the lid 106 of the top assembly 102 can at least partially cover a cavity 202 formed by the base 104 when coupled to the base 104. Residing at least partially within the cavity 202 can be, among other things, a needle 204 and an inner component 206. The inner component 206 can be configured to selectively rotate about an axis of rotation 208 relative to the base 104 within the cavity 202 of the base 104. Additionally, the needle 204 can be coupled to the inner component 206, such that rotation of the inner component 206 moves the needle 204 as well.

[0032] The upper assembly 102 can include a driver 210 and a spring 212 positioned within the lid 106. The driver 210 can be selectively rotatable relative to the lid 106 about an axis of rotation 208 when coupled to the base 104. In one aspect of the disclosure, the spring 212 can be loaded to provide a rotational force to the driver 210 relative to the lid 106. The release mechanism 108 can be selectively coupled to the driver 210 and can substantially prevent the driver 210 from rotating relative to the lid 106. However, when the release mechanism 108 is removed, the loaded spring 212 can rotate the driver 210 relative to the lid 106.

[0033] In one aspect of the disclosure, the driver 210 and the inner component 206 may have a corresponding feature 214 such that the driver 210 is rotationally locked to the inner component 206 when the upper assembly 102 is coupled to the base 104. The corresponding feature 214 may be any feature that rotatably locks the driver 210 to the inner component 106 when the upper assembly 102 is coupled to the base 104. In the example of FIG. 2, the corresponding feature is a circular recess on a surface of the inner component 206 and a corresponding circular protrusion on the driver 210. In this configuration, when the upper assembly 102 is coupled to the base 104, the circular protrusion of the driver 210 is at least partially positioned within the circular recess of the inner component 206, thereby preventing substantial relative rotation between the driver 210 and the inner component 206. Additionally, in this configuration, the upper assembly 102 can be easily removed from the base 104 and the circular protrusion of the driver 210 can move axially away from the circular recess along the axis of rotation 208, separating the driver from the inner component when the upper assembly 102 is removed. When the driver 210 is coupled to the inner component 206 with the corresponding mechanism 214, rotation of the driver 210 causes rotation of the inner component 206.

[0034] The needle 204 can be sufficiently bendable or deformable to allow the needle 204 to bend within the cavity 202. More specifically, the base can have a cylindrical wall 216 that defines a perimeter of the cavity 202. In the retracted position, the needle 204 can be positioned substantially within the cavity 202, where the needle 204 partially follows the contour of the inner surface of the cylindrical wall 216. This orientation of the needle 204 is shown in FIG. 2 as if the needle 204 were positioned within the cavity 202. In one aspect of the present disclosure, the needle 204 has material properties that allow the needle 204 to bend under load while maintaining a substantially straight orientation otherwise. That is, when the needle 204 is not positioned within the cavity 202 and is not bent along the cylindrical wall 216, the needle 204 would be substantially straight.

[0035] The base 104 may also have an insertion angle component 218 coupled to or formed within the base 104. The insertion angle component 218 may have guide channels therein that guide the bendable needle 204 from the cavity 202, through the surface 402, and out of the base 104 (see FIG. 4). In one aspect of the disclosure, the insertion angle component 218 may deflect or bend the needle 204 in an orientation that provides a preferred entry angle for the needle in the extended position.

[0036] The insertion angle component 218 may be selectively interchangeable within the base 104, with different insertion angle components 218 providing different insertion angles. In this configuration, a manufacturer, healthcare provider, or user can select the insertion angle component 218 that provides the ideal insertion angle for the needle 204 in a given situation. In an alternative embodiment, the insertion angle component 218 is molded into the base 104 at the time of manufacture, and the insertion angle is preset and not adjustable.

[0037] 3a and 3b, cross-sectional views of the inserter assembly 100 are shown illustrating the fluid channels of the inserter assembly 100. FIG. 3a illustrates a cross-sectional view through the rotation axis 208 and the base fluid channel 302. The base fluid channel 302 may be a fluid channel defined by the base 104 that extends radially from the rotation axis 208 to a coupler 304. The coupler 304 may be sized to be coupled to a fluid source to fluidly couple the fluid source to the base fluid channel 302. The base fluid channel 302 may extend radially inward toward the rotation axis 208 and is partially defined along the rotation axis 208. Additionally, the base fluid channel 302 may extend axially toward the inner part 206 around a central orifice.

[0038] The inner piece 206 may have a corresponding inner fluid channel 306 that is fluidly coupled to the base fluid channel 302 at a central orifice. More specifically, a circular seal 308 may be positioned around the central orifice to fluidly seal the base fluid channel 302 from the inner fluid channel 306. In this configuration, the inner fluid channel 306 may remain fluidly coupled to the base fluid channel 302 regardless of the rotational angle of the inner piece 206 relative to the base 104.

[0039] 3b, a cross-sectional view of an upper portion of the inner fluid channel 306 is shown. As shown in FIG. 3b, the inner fluid channel 306 extends axially away from the base 104 over a length and then extends radially away from the axis of rotation 208 towards a needle coupling component 310. The needle coupling component 310 may be a material that provides an interface for fluidly coupling the inner fluid channel 306 to the needle fluid channel 312. In one aspect of the disclosure, the needle 204 may be molded into the needle coupling component 310 to ensure fluid coupling between the needle fluid channel 312 and the needle coupling component 310. Additionally, a seal or the like may be positioned between the inner fluid channel 306 and the needle coupling component 310 to fluidly seal the passage from the needle coupling component 310 to the inner fluid channel 306.

[0040] In one embodiment contemplated herein, one or more filters 314 may be positioned within the fluid channel between the coupler 304 and the distal tip 406 of the needle 204. The filters may be positioned to filter fluid passing through the fluid channels 302, 306, 312 to remove impurities therein or to prepare the fluid for introduction into the user's soft tissue. In one example, the filter 314 at least partially filters one or more of phenol and meta-cresol residues from the fluid passing therethrough. However, other types of filters are contemplated herein as the filter 314.

[0041] In the configuration shown in FIGS. 3a-b, fluid provided to the base fluid channel 302 from the coupler 304 is directed to the inner fluid channel 306 and through the needle coupling component 310 to enter the needle fluid channel 312. Once in the needle fluid channel 312, the fluid will travel towards the distal tip 404 of the needle 204 for administration. In other words, the inserter assembly 100 can be fluidly coupled to a fluid source to deliver fluid through the needle 204. In one aspect of the present disclosure, the fluid source can be a reservoir with a pump that supplies fluid to the fluid channel 302 via, among other things, an electric pump (i.e., an electrically driven pump or a pressure driven pump, either by gravity or an overpressure vessel), or a manual pump (i.e., a syringe, etc.).

[0042] 4, the inserter assembly 100 is shown in an extended position 400 with the needle 204 at least partially extending past a surface 402 of the base 104. As the needle 204 extends from the insertion angle component 218, the needle 204 returns to a generally straight shape. Additionally, the insertion angle component 218 can determine an insertion angle 404 of the needle 204. The desired insertion angle may vary for different applications and users of the inserter assembly 100. In this manner, the insertion angle 404 of the same needle 204 can be substantially controlled by the insertion angle component 218. As described herein, the insertion angle component 218 may be interchangeable to generate different insertion angles 404. Additionally, the insertion angle component 218 may be formed with the base 104 and preset during manufacture.

[0043] In yet another embodiment of the inserter assembly 500 shown in FIG. 5, a movable insertion angle component 502 extends from the cylindrical wall 216 of the base 104 into the cavity 202 of the base 104 to selectively manipulate the insertion angle 404 of the needle 204. This embodiment 500 may be substantially similar to the embodiment described with reference to FIGS. 1-4, except that it has a movable insertion angle component 502 instead of the insertion angle component 218. The movable insertion angle component 502 may be rotatable by a user to manipulate a corresponding channel through which the needle 204 must pass before exiting the base 104. In this configuration, the movable insertion angle component 502 may be engaged by a user to change the insertion angle 404 of the needle 204.

[0044] In embodiments with a movable insertion angle component 502, the insertion angle 404 can be adjustable to any angle between about 90 degrees and less than 20 degrees. Alternatively, the insertion angle component 218 can be manufactured to provide any insertion angle 404 between about 90 degrees and less than 20 degrees. In one aspect of the disclosure, the insertion angle 404 can be preset to about 30 degrees.

[0045] In other aspects of the present disclosure, the insertion depth 408 can be user selectable as well. More specifically, the rotation angle of the inner part 206 from a retracted position (i.e., FIG. 3a) to an extended position (i.e., FIG. 4) can control the insertion depth 408 of the needle 204. In other words, a relatively large rotation angle of the inner part 206 will have a larger insertion depth 408 than a relatively small rotation angle. Thus, in one embodiment contemplated herein, the rotation angle of the inner part 206 may be selectively changed to modify the insertion depth 408. In one example of the present disclosure, the insertion depth 408 can be preset to approximately 3-4 millimeters. However, other embodiments contemplated herein include insertion depths greater than 4 millimeters or less than 3 millimeters.

[0046] 8a and 8b, the top assembly 102 may be selectively removable from the base 104. More specifically, the top assembly 102 may be friction-fitted, clipped, or otherwise removably coupled to the base 104, with corresponding features 214 on the inner component 206 and the driver 210 aligned to rotatably couple the driver 210 to the inner component 206. More specifically, the top assembly 102 may have a coupling groove 802 that corresponds to a coupling peg 804 on the base 104. The groove 802 may be formed on a radially inner surface of the top assembly 102, and the peg 804 may be formed on a radially outer portion of the cylindrical wall 216. Alternatively, the peg may be defined from the top assembly 102 and the groove may be formed in the cylindrical wall 216. The upper assembly 102 can still be selectively coupled to the base 104 by positioning the peg 804 in the groove 802 and rotating the upper assembly 102 to position the peg 804 along a portion of the groove 802 without allowing substantial axial movement of the upper assembly 102 from the base 104. In this configuration, the driver 210 can be rotatably coupled to the inner component 206 via a corresponding mechanism 214. Additionally, the upper assembly 102 can be removed from the base 104 by rotating the upper assembly to allow the peg 804 to slide axially along the groove 802 and separate the upper assembly 102 from the base 104.

[0047] When the upper assembly 102 is coupled to the base 104 and the inner part 206 is coupled to the driver 210, the inner part 206 rotates the needle to the extended position after the release mechanism 108 is released. The upper assembly 102 can then be removed from the base 104, as shown in Figure 6. In this configuration, the upper assembly 102 can be removed when not needed (i.e., after the needle 204 has transitioned to the extended position) to provide a lighter, more compact inserter assembly.

[0048] In another aspect of the disclosure, the inserter assembly 100 allows the needle 204 to transition from an extended position to a retracted position. More specifically, a return spring 220 can be positioned between the inner part 206 and the base 104 to provide a biasing force on the inner part 206 toward the retracted position. When a user wishes to retract the needle 204, the activator 802 can be engaged to release the locking pin 804, thereby releasing the inner part 206 to rotate toward the retracted position. Once the locking pin 802 releases the inner part 206, the return spring 220 can provide an auxiliary force to return the needle to the retracted position.

[0049] The bending, deflection and / or deformation of the needle 204 in the base 104 is shown in the cross-sectional view of FIG. 7 with the inner component 206 removed. More specifically, the needle 204 is shown having three different orientation sections 702, 704, 706. More specifically, in the first section 702, the needle 204 can be positioned between a shelf 708 defined in an inner portion of the cylindrical wall 216 of the base 104 and the inner component 206 (the inner component 206 is not shown in FIG. 7). In the first section 702, the needle 204 can maintain a substantially arcuate profile as it bends along the inner contour of the cylindrical wall 216. However, as the needle 204 enters the second section 704, the needle 204 can bend toward the insertion angle component 218, changing the orientation of the needle 204 relative to the first section 702. In the second section 704 , the ledge 708 terminates, allowing the needle 204 to deflect towards the insertion angle component 218 .

[0050] The third section 706 is within the insertion angle component 218. The third section 706 can have a substantially straight through hole defined therethrough, thereby providing a straight exit for the needle 204. As described herein, the insertion angle component 218 can change the insertion angle 404 of the needle 204. In this embodiment, the insertion angle 404 can be determined by the angle of the straight through hole through the insertion angle component 218. Yet, once the needle 204 exits the insertion angle component 218, it will maintain a substantially straight orientation. In other words, the needle 204 can transition through three distinct orientations before exiting the insertion angle component 218.

[0051] As described herein, as the inner component 206 rotates about the axis of rotation 208, the needle 204 advances through sections 702, 704, and 706. As the inner component 206 rotates about the axis of rotation 208 in a counterclockwise direction from the perspective of FIGURE 7, the needle 204 is pushed by the inner component 206 and urged to an extended position through the insertion angle component 218. Alternatively, the inner component 206 can rotate about the axis of rotation 208 in a clockwise direction from the perspective of FIGURE 7 to retract the needle 204 through the insertion angle component 218 to a retracted position.

[0052] In use, the inserter assembly 100 can have a preloaded spring 212 and an upper assembly 102 with an adhesive patch or the like on the base 104 about the surface 402. The inserter assembly 100 can be in a retracted position and coupled to the skin of a user via the adhesive patch. When coupled to the skin of the user, the surface 402 is substantially adjacent to the skin of the user. Once positioned on the skin of the user, the release mechanism 108 can be selectively removed by the user, a healthcare provider, or other personnel. The release mechanism 108 can be pulled from the through hole in the lid 106 and the driver 210, allowing the driver 210 to rotate freely relative to the lid 106.

[0053] Once the release mechanism 108 is removed, the spring 212 rotates the driver 210, which in turn rotates the inner component 206 coupled to the driver 210 via a corresponding mechanism 214, transitioning the needle 204 from a retracted position (see FIG. 3a) to an extended position (see FIG. 4). As the inner component 206 rotates, the needle 204 rotates with it, driving the distal tip 406 through the insertion angle component 218 and into the user's soft tissue. The insertion angle component 218 biases the needle 204 to have a desired insertion angle 404, and the rotation angle of the inner component 206 can control the insertion depth 408. As the needle 204 extends into the user's soft tissue, the portion of the needle 204 that enters the soft tissue maintains a generally straight orientation. Once in the extended position, the user, healthcare provider, or other personnel can remove the upper assembly 102 to reduce the size and weight of the device.

[0054] A user, healthcare provider, or other personnel can selectively retract the needle 204 from the extended position to the retracted position by rotating the inner component 206 in the opposite direction to that in which it was transitioned to the extended position. In one example, a spring may provide a spring force on the inner component toward the retracted position, and a user can selectively release the inner component to allow the spring to retract the needle 204 to the retracted position.

[0055] In another example of the present disclosure, the upper assembly 102 can act as a key to extend or retract the needle 204. More specifically, the base 104, inner part 206 and needle 204 can be coupled to the user via an adhesive patch or the like. The upper assembly 102 can then be manipulated into a loaded and filled position with a release mechanism engaged to hold the loaded and filled configuration. In one example, the upper assembly 102 can be loaded and filled by rotating the driver 210 relative to the lid 106 until the release mechanism engages a catch on the driver 210 to maintain the loaded and filled position. Once loaded and filled, the upper assembly is positioned on the base and the corresponding mechanism 214 on the inner part 206 is aligned with the driver 210, and the inner part 206 and the driver 210 are rotatably secured relative to each other. The upper assembly 102 can be released by removing the release mechanism 108, and the needle 204 can be transitioned from the retracted position to the extended position.

[0056] In other aspects of the disclosure, a process substantially similar to that described above can be implemented to retract the needle 204. More specifically, the upper assembly 102 can be loaded in a retracted configuration and positioned above the base 104, and the release mechanism 108 can be released to allow the drive 210 to rotate the inner component 206 towards the retracted position.

[0057] In other embodiments contemplated herein, a rotational actuator may rotate the inner component 206 relative to the base 104 to transition the needle 204 from the retracted position to the extended position. More specifically, the rotational actuator may be coupled to the base 104 such that movement of the rotational actuator causes rotation of the inner component 206 relative to the base 104. In one example, the rotational actuator may be an electric motor coupled to a gear that engages the inner component 206 such that when the motor is energized, it can selectively rotate the inner component 206 to transition the needle 204 between the retracted and extended positions.

[0058] In yet another embodiment of the present disclosure, as shown in Figures 10a and 10b, the inner part 206 may have fluid channels leading to two separate needles 1002, 1004. Each needle 1002, 1004 may be coupled to the inner part 206 offset from one another by approximately 180 degrees about the axis of rotation 208. In this configuration, the needles 1002, 1004 may extend downward toward the surface 402 in substantially the same manner as described herein with reference to Figures 1-7. That is, the second needle 1004 may be in a substantially mirror image configuration of the needle 204 and corresponding components described herein. In this configuration, rotation of the inner part 206 may transition both needles 1002, 1004 between retracted and extended positions. Additionally, two separate base fluid channels may be defined within the base 104 to allow each needle 1002, 1004 to be fluidly coupled to a separate fluid source. Other than having a second needle 1004, the embodiment of Figures 10a and 10b can function substantially similarly to the other embodiments shown and described herein.

[0059] While embodiments incorporating the principles of the present disclosure have been described above, the present disclosure is not limited to those embodiments. Instead, this application is intended to cover any variations, uses, or adaptations of the present disclosure using its general principles. Moreover, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which the disclosure pertains and fall within the scope of the appended claims.

Claims

1. With the base, Needle and an inner component configured to selectively transition the needle from a retracted position substantially within the base to an extended position in which at least a portion of the needle extends outside the base; An insertion angle component, When the inner part transitions from the retracted position to the extended position, the needle is at least partially deflected by the insertion angle component; The inner part is rotatably coupled to the base about an axis of rotation; An inserter assembly, wherein the inner part is coupled to the needle such that rotation of the inner part about the axis of rotation moves the needle about the axis of rotation.

2. the needle is resiliently deformable to fit within the base and deflects through contact with the insertion angle component as the needle transitions from the retracted position to the extended position; The inserter assembly of claim 1 , wherein the needle maintains a substantially straight shape as it extends outside the base.

3. a base fluid channel partially defined in the base and an inner fluid channel defined in the inner component; The inserter assembly of claim 1 , wherein the base fluid channel is fluidly coupled to the inner fluid channel.

4. 4. The inserter assembly of claim 3, wherein the inner fluid channel is fluidly coupled to the needle fluid channel, and fluid from the base fluid channel is directed partially through the inner fluid channel of the inner part and into the needle fluid channel of the needle, regardless of the rotation angle of the inner part relative to the base about the rotation axis.

5. the base fluid channel is fluidly coupled to the inner fluid channel at least partially along the axis of rotation; 4. The inserter assembly of claim 3, further comprising a circular seal positioned between the inner part and the base to fluidly seal the transition between the base fluid channel and the inner fluid channel regardless of the angular orientation of the inner part relative to the base about the axis of rotation.

6. an upper assembly selectively operable to transition the needle from a retracted position to an extended position; The inserter assembly of claim 1 , wherein the upper assembly comprises a driver, a lid, a release mechanism, and a spring positioned therebetween.

7. The inserter assembly of claim 1 , wherein the base defines a base fluid channel fluidly coupled to the needle for supplying a fluid, the base fluid channel configured to be fluidly coupled to a fluid delivery device.

8. The inserter assembly of claim 1 , wherein the insertion angle component is removable from the base.

9. 10. The inserter assembly of claim 8, wherein a plurality of different insertion angle components are coupleable to the base to provide selectable insertion angles of the needle in the extended position based on the particular insertion angle component coupled to the base.

10. The inserter assembly of claim 1 , wherein the insertion angle component is movable to change the insertion angle of the needle in the extended position.

11. The inserter assembly of claim 1 , wherein the degree of rotation of the inner part relative to the base is variable to vary the insertion depth of the needle in the extended position.

12. The inserter assembly of claim 1 , wherein in the extended position, the needle extends approximately 3-4 millimeters from the base.

13. The inserter assembly of claim 1 , wherein a rotational actuator rotates the inner part relative to the base to transition the needle from the retracted position to the extended position.

14. The inserter assembly of claim 13 , wherein the rotational actuator is coupled to a gear to rotate the inner part.

15. The inserter assembly of claim 1 , further comprising a second needle coupled to the inner part, wherein transitioning the inserter assembly from the retracted position to the extended position extends at least a portion of the second needle outside the base.

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