Insertion tool with dissection instrument

Abstract

An insertion tool for creating a subcutaneous pocket and implanting a device in the pocket. The tool may include a cannula extending from a handle, a dissector tip disposed at a distal end of the cannula, and a rod. The cannula and dissector tip may create the pocket. The cannula may include a passageway and an opening to the passageway, and the cannula may be disposed within the passageway and moveable along the passageway between a retracted position and an extended position. The rod and cannula may be configured such that when the rod is in the retracted position, the cannula holds the device in the passageway, and as the cannula moves from the extended position to the retracted position, the rod pushes the device into the opening at the distal end of the cannula, at least partially out of the cannula, and at least partially into the pocket.

Description

Technical Field

[0001] Cross - Reference to Related Applications

[0001] This application claims the benefit of priority of U.S. Provisional Application No. 63 / 010,661, filed on April 15, 2020, which is hereby incorporated by reference in its entirety.

[0002]

[0002] Technical Field

[0003] The present disclosure relates to a tunneling tool for creating a subcutaneous pocket under the skin surface and implanting a device into the subcutaneous pocket.

Background Art

[0003]

[0004] Consideration of the Background

[0005] Implanted devices can be implanted in living animals (e.g., humans). Some implanted devices are implanted in the subcutaneous tissue under the skin. Some implanted devices can detect the presence or amount of an analyte (e.g., glucose or oxygen) in a medium (e.g., blood or interstitial fluid) within a living animal.

[0004]

[0006] Known tools for inserting an implanted device into the subcutaneous tissue include tunneling tools and insertion tools. A tunneling tool can be used to create a tunnel and a subcutaneous pocket under the skin surface, and an insertion tool can be used to deliver a device through the tunnel into the subcutaneous pocket.

[0005]

[0007] However, when using an insertion tool, the device is typically exposed at the distal end of the insertion tool, whereby the device is guided by the insertion tool into a tunnel beneath the skin surface. Often, the user has to rotate the insertion tool back and forth to push the device into the tunnel and place the device in the pocket. Such exposure and force can cause the device to become detached from the insertion tool before reaching the subcutaneous pocket and / or damage the device. Further, exposing the device at the distal end of the insertion tool during implantation of the device can cause trauma inside the pocket, resulting in increased bleeding and possible distortion of the signal transmitted from the device.

[0006]

[0008] Accordingly, there is a need for an improved insertion tool to protect the device from exposure to skin tissue during insertion and to reduce trauma to the subcutaneous pocket during implantation of the device. The improved insertion tool can thereby extend the life of the device and / or improve accuracy.

SUMMARY OF THE INVENTION

MEANS FOR SOLVING THE PROBLEM

[0007]

[0009] Aspects of the present invention can relate to an improved insertion tool for protecting an implantable device from exposure to skin tissue during insertion. Embodiments of the improved insertion tool can reduce trauma to the subcutaneous pocket while implanting the device.

[0008]

[0010] One aspect of the present invention can provide an insertion tool that creates a subcutaneous pocket under the skin surface and embeds a device in the subcutaneous pocket. In some embodiments, the insertion tool may include a handle. In some embodiments, the insertion tool may include a cannula extending from the handle, the cannula including a passageway and an opening to the passageway at the distal end of the cannula. In some embodiments, the cannula may be configured to move axially between an extended position and a retracted position. In some embodiments, the insertion tool may include a dissection instrument tip disposed at the distal end of the cannula, the cannula and the dissection instrument tip being configured to create a subcutaneous pocket under the skin surface. In some embodiments, the insertion tool may include a rod disposed within the passageway of the cannula and configured to remain stationary relative to the handle within the passageway of the cannula as the cannula moves between the extended position and the retracted position. In some embodiments, the insertion tool may include an actuator disposed within the handle and operably connected to the cannula, the actuator being configured to move the cannula between the retracted position and the extended position. In some embodiments, the rod and the cannula may be spatially separated from the distal end of the cannula when the cannula is in the extended position, and the cannula may be configured to hold a device within the passageway of the cannula. In some embodiments, the rod and the cannula may be disposed proximate to the distal end of the cannula when the cannula is in the retracted position or near it, and when the cannula moves from the extended position to the retracted position, the rod may be configured to push the device into the opening at the distal end of the cannula, at least partially out of the cannula, and at least partially into the subcutaneous pocket.

[0009]

[0011] In some embodiments, the distal end of the dissection instrument may comprise a sleeve around at least a portion of the cannula. In some embodiments, the sleeve may be configured to be pulled along the cannula from a closed position to an open position, wherein in the closed position, the sleeve surrounds the opening at the distal end of the cannula, and in the open position, the sleeve exposes the opening at the distal end of the cannula. In some embodiments, the sleeve may comprise one or more perforations configured to separate when the sleeve is pulled along the cannula from the closed position to the open position.

[0010]

[0012] In some embodiments, the actuator may be operably connected to the sleeve such that the actuator is configured to move the sleeve between a closed position and an open position. In some embodiments, the actuator may be configured to move the sleeve from the closed position to the open position before moving the cannula from an extended position to a retracted position. In some embodiments, the actuator may be operably connected to the sleeve such that the actuator is configured to move the sleeve between a closed position and an open position. In some embodiments, the actuator may be configured to move the sleeve from the closed position to the open position before moving the cannula from an extended position to a retracted position.

[0011]

[0013] In some embodiments, the distal end of the cannula may be bevel-shaped and the distal end of the dissection instrument may include a protrusion from the distal end of the cannula. In some embodiments, the insertion tool may include a sleeve around at least a portion of the cannula and may surround the opening at the distal end of the cannula. In some embodiments, the sleeve may be configured to be pulled along the cannula from a closed position to an open position, wherein in the closed position, the sleeve surrounds the opening at the distal end of the cannula, and in the open position, the sleeve exposes the opening at the distal end of the cannula. In some embodiments, the sleeve may comprise one or more perforations configured to separate when the sleeve is pulled along the cannula from the closed position to the open position.

[0012]

[0014] In some embodiments, the dissection instrument tip may be of a blunt shape. In some embodiments, the distal end of the cannula may be beveled, and the dissection instrument tip may comprise a flap coupled to the cannula, the flap being configured to cover the opening at the distal end of the cannula. In some embodiments, the flap may be configured to pivot between a closed position in which the flap surrounds the opening at the distal end of the cannula and an open position in which the flap is spatially separated from the distal end of the cannula and exposes the opening at the distal end of the cannula. In some embodiments, the actuator may comprise a track extending along a portion of the handle and a slider knob configured to slide along the track and move the rod between a retracted position and an extended position.

[0013]

[0015] Another aspect of the present invention may provide an insertion tool for creating a subcutaneous pocket under the skin surface and implanting a device into the subcutaneous pocket. In some embodiments, the insertion tool may include a handle that defines a cavity therein. In some embodiments, the insertion tool may include a tunneling tube that extends from a first end of the handle and defines a passage that opens into the cavity of the handle, and the tunneling tube is configured to move axially between an extended position and a retracted position. In some embodiments, the dissection instrument may include a blunt tip configured to move between a retracted position where the blunt tip is disposed within the cavity of the handle and an extended position where the blunt tip protrudes from the distal end of the tunneling tube and the dissection instrument is configured to create a subcutaneous pocket. In some embodiments, the insertion tool may include an inserter including a cannula configured to move between a retracted position where the cannula is disposed within the cavity of the handle and an extended position where the cannula is at least partially disposed within the passage of the tunneling tube. In some embodiments, the insertion tool may include an actuator disposed within the handle, the actuator being operably coupled to the cannula, the dissection instrument, and the inserter such that the actuator is configured to move the cannula, the blunt tip, and the cannula between the retracted position and the extended position. In some embodiments, the tunneling tube and the cannula may be configured such that when the tunneling tube and the cannula are in the extended position, the cannula holds the device within the passage of the cannula. In some embodiments, the tunneling tube and the cannula may be configured such that when the tunneling tube is in or near the retracted position, the cannula moves toward the retracted position to release the device from the tunneling tube and dispose the device in the subcutaneous pocket.

[0014]

[0016] In some embodiments, the dissection instrument may be configured to pivot from an operative position disposed along a first axis defined by the tunneling tube to an idle position disposed along a second axis, the inserter may be configured to pivot from an idle position disposed along a third axis to an operative position disposed along the first axis, the second axis extends at a first acute angle with respect to the first axis, and the third axis extends at a second acute angle with respect to the first axis. In some embodiments, the handle may include a hinge pivotally coupled to the dissection instrument and the inserter. In some embodiments, the inserter may be configured to pivot between the operative position and the idle position when the cannula tube is set to the retracted position, and the cannula tube is configured to move between the retracted position and the extended position when the inserter is set to the operative position.

[0015]

[0017] In some embodiments, the actuator may include a track extending along a portion of the handle and a slider knob configured to slide along the track and move the tunneling tube, the blunt tip, and the cannula between the retracted position and the extended position. In some embodiments, the dissection instrument may include a first rod configured to move along the cavity of the handle and the passage of the tunneling tube, and the blunt tip may be coupled to the first rod such that the first rod is configured to move the blunt tip between the retracted position and the extended position along the cavity of the handle and the passage of the tunneling tube. In some embodiments, the inserter may include a second rod configured to move along the cavity of the handle and the passage of the tunneling tube, and the cannula may include a first end configured to hold and release the device and a second end coupled to the second rod, the second rod being configured to move the cannula between the retracted position and the extended position along the cavity of the handle and the passage of the tunneling tube.

[0016]

[0018] Yet another aspect of the present invention may provide a method of creating a subcutaneous pocket under the skin surface using an insertion tool and implanting a device into the subcutaneous pocket. In some embodiments, the method may include inserting a cannula of the insertion tool and a dissection instrument tip disposed at the distal end of the cannula into an incision in the skin surface such that the dissection instrument tip and the cannula create the subcutaneous pocket. In some embodiments, the method may include moving the cannula axially from an extended position to a retracted position such that a rod disposed along the passageway of the cannula pushes the device through an opening at the distal end of the cannula, at least partially out of the passageway of the cannula, and at least partially into the subcutaneous pocket.

[0017]

[0019] In some embodiments, the method may further include loading the device into the passageway of the cannula. In some embodiments, the method may further include pulling a sleeve around the distal end of the cannula to surround the opening at the distal end of the cannula after loading the device into the passageway and before inserting the cannula and the dissection instrument tip. In some embodiments, the method may further include pulling a sleeve received around the cannula toward the handle to expose the opening at the distal end of the cannula prior to the loading step. In some embodiments, the method may further include pulling the cannula away from the subcutaneous pocket.

[0018]

[0020] In some embodiments, the method may further include using an actuator disposed on the handle to move the cannula from the extended position to the retracted position. In some embodiments, the method may further include pulling the sleeve from a closed position in which the sleeve surrounds the opening at the distal end of the cannula to an open position in which the sleeve exposes the opening at the distal end of the cannula along the cannula. In some embodiments, the method may further include spatially separating the flap from the distal end of the cannula by covering the opening at the distal end of the cannula with the flap and moving the rod from the retracted position to the extended position along the passage of the cannula, thereby exposing the opening at the distal end of the cannula.

[0019]

[0021] Yet another aspect of the present invention may provide an insertion tool for creating a subcutaneous pocket under the skin surface and implanting a device in the subcutaneous pocket. The insertion tool may include a handle defining a cavity therein. The insertion tool may include a tunneling tube defining a passage opening into the cavity of the handle. The insertion tool may include a dissecting instrument having a blunt tip. The dissecting instrument may be configured to (i) create a subcutaneous pocket, (ii) move between a retracted position in which the blunt tip is disposed within the cavity of the handle and an extended position in which the blunt tip protrudes from the distal end of the tunneling tube, and (iii) rotate from an operative position disposed on the longitudinal axis of the tunneling tube to an idle position disposed away from the longitudinal axis of the tunneling tube. The insertion tool may include an inserter including a cannula. The inserter may be configured to (i) hold a device in the passage of the cannula, (ii) rotate from an idle position disposed away from the longitudinal axis of the tunneling tube to an operative position on the longitudinal axis of the tunneling tube, and (iii) move from a retracted position to an extended position to release the device from the tunneling tube and dispose the device in the subcutaneous pocket.

[0020]

[0022] In some embodiments, the inserter may be configured to hold a hydrating fluid within the cannula passageway. In some embodiments, the handle may include a hinge rotatably coupled to the dissection instrument and the inserter. In some embodiments, the inserter may be configured to move from a retracted position to an extended position when the inserter is set to the operative position. In some embodiments, the actuator may include a slider knob configured to move the inserter and the dissection instrument between a retracted position and an extended position. In some embodiments, the insertion tool may further include a mechanism that prevents rearward movement of the actuator's slider knob after rotating the inserter to the operative position so that the cannula of the inserter can only move toward the extended position of the inserter. In some embodiments, the mechanism may be a ratchet.

[0021]

[0023] In some embodiments, the dissection instrument may include a first rod configured to move along the handle cavity and the tunneling tube passageway, and the blunt tip may be coupled to the first rod such that the first rod is configured to move the blunt tip between a retracted position and an extended position along the handle cavity and the tunneling tube passageway. In some embodiments, the inserter may include a second rod configured to move along the handle cavity and the tunneling tube passageway, and the cannula may include a first end configured to hold and release the device and a second end coupled to the second rod, where the second rod is configured to move the cannula between a retracted position and an extended position along the handle cavity and the tunneling tube passageway.

[0022]

[0024] Yet another aspect of the present invention may provide a method of creating a subcutaneous pocket under the skin surface and implanting a device in the subcutaneous pocket. The method may include using a dissecting instrument of an insertion tool with the blunt tip of the dissecting instrument in an extended position where it protrudes from the distal end of the tunneling tube to create the subcutaneous pocket, and the tunneling tube may define a passage opening into the cavity of the handle. The method may include moving the dissecting instrument from the extended position to a retracted position where the blunt tip is disposed within the cavity of the handle. The method may include rotating the dissecting instrument from an operative position disposed on the longitudinal axis of the tunneling tube to an idle position disposed away from the longitudinal axis of the tunneling tube. The method may include using an inserter of the insertion tool to hold the device within the passage of the cannula of the inserter. The method may include rotating the inserter from an idle position disposed away from the longitudinal axis of the tunneling tube to an operative position disposed on the longitudinal axis of the tunneling tube. The method may include moving the inserter from the retracted position to the extended position, and by moving the inserter from the retracted position to the extended position, the device can be released from the tunneling tube and placed in the subcutaneous pocket.

[0023]

[0025] In some embodiments, the method may further include using an inserter to hold a hydrating fluid within the cannula passageway. In some embodiments, the step of rotating the dissection instrument and the step of rotating the inserter may include using a hinge rotatably coupled to the dissection instrument and the inserter. In some embodiments, moving the inserter from a retracted position to an extended position may include moving the inserter from a retracted position to an extended position while the inserter is in an operative position. In some embodiments, moving the dissection instrument from an extended position to a retracted position and moving the inserter from a retracted position to an extended position may include using a slider knob to move the inserter and the dissection instrument. In some embodiments, moving the inserter from a retracted position to an extended position may include preventing rearward movement of the slider knob of the actuator such that the cannula of the inserter can only move toward the extended position.

[0024]

[0026] In some embodiments, the dissection instrument may include a first rod configured to move along the cavity of the handle and the passageway of the tunneling tube, and the blunt tip may be coupled to the first rod such that the first rod is configured to move the blunt tip between a retracted position and an extended position along the cavity of the handle and the passageway of the tunneling tube. In some embodiments, the inserter may include a second rod configured to move along the cavity of the handle and the passageway of the tunneling tube, and the cannula may include a first end configured to hold and release the device and a second end coupled to the second rod, wherein the second rod is configured to move the cannula between a retracted position and an extended position along the cavity of the handle and the passageway of the tunneling tube.

[0025]

[0027] Further variations included in the insertion tool and method are described in the following detailed description of the invention.

[0026]

[0028] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate various embodiments of the subject matter of the present disclosure. In the drawings, like reference numerals identify the same or functionally similar elements.

Brief Description of the Drawings

[0027]

Figure 1

[0029] It is a schematic diagram of an insertion tool embodying an aspect of the present disclosure.

Figure 2A

[0030] It is a perspective view of the operative tip of an anatomical instrument pull sleeve in a closed position with the push rod retracted, embodying an aspect of the present disclosure.

Figure 2B

[0031] It is a side cross-sectional view of the operative tip of a pull sleeve in a closed position with the push rod retracted, embodying an aspect of the present disclosure.

Figure 2C

[0032] It is a perspective view of the operative tip of an anatomical instrument pull sleeve in an open position with the push rod retracted, embodying an aspect of the present disclosure.

Figure 2D

[0033] It is a side cross-sectional view of the operative tip of an anatomical instrument pull sleeve in an open position with the push rod retracted, embodying an aspect of the present disclosure.

Figure 2E

[0034] It is a perspective view of the operative tip of an anatomical instrument pull sleeve in an open position with the push extended, embodying an aspect of the present disclosure.

Figure 2F

[0035] It is a side cross-sectional view of the operative tip of an anatomical instrument pull sleeve in an open position with the push rod extended, embodying an aspect of the present disclosure.

Figure 3A

[0036] It is a side cross-sectional view of the bevelled tip of an insertion tool anatomical instrument pull sleeve in a closed position with the push rod retracted, embodying an aspect of the present disclosure.

Figure 3B

[0037] It is a perspective view of the bevelled tip of an insertion tool anatomical instrument pull sleeve in a closed position with the push rod retracted, embodying an aspect of the present disclosure.

Figure 3C

[0038] Perspective view of the bevel-shaped tip of the insertion tool dissection instrument pull sleeve actuating bevel with the push rod in the retracted open position embodying an aspect of the present disclosure.

Figure 4

[0039] Side cross-sectional view of the support tip of the insertion tool dissection instrument with the push rod in the retracted closed position embodying an aspect of the present disclosure.

Figure 5

[0040] Side cross-sectional view of the support bevel-shaped tip of the insertion tool dissection instrument with the push rod in the retracted closed position embodying an aspect of the present disclosure.

Figure 6A

[0041] Side cross-sectional view of the bevel-shaped tip covered with the insertion tool dissection instrument plug in the closed and retracted positions embodying an aspect of the present disclosure.

Figure 6B

[0042] Perspective view of the bevel-shaped tip covered with the insertion tool dissection instrument plug with the push rod in the retracted open position embodying an aspect of the present disclosure.

Figure 7A

[0043] Side cross-sectional view of the insertion tool dissection instrument having a device as a nose cone with the push rod in the retracted position embodying an aspect of the present disclosure.

Figure 7B

[0044] Side cross-sectional view of the insertion tool dissection instrument having a device as a nose cone with the push rod in the extended position embodying an aspect of the present disclosure.

Figure 7C

[0045] Perspective view of the insertion tool dissection instrument having a device as a nose cone with the push rod in the retracted position embodying an aspect of the present disclosure.

Figure 8A

[0046] Side cross-sectional view of the insertion tool with the dissection instrument tip set to the extended position and the cannula set to the retracted position embodying an aspect of the present disclosure.

Figure 8B

[0047] Side cross-sectional view of the insertion tool with the dissection instrument tip set to the retracted position and the cannula set to the extended position embodying an aspect of the present disclosure.

Figure 9A

[0048] Schematic diagram of an insertion tool embodying an aspect of the present disclosure, with the tip of the dissection instrument set in the extended position and the cannula set in the retracted position.

Figure 9B

[0049] Schematic diagram of an insertion tool embodying an aspect of the present disclosure, with the tip of the dissection instrument set in the retracted position and the cannula set in the extended position.

Figure 10

[0050] Schematic diagram of an insertion tool embodying an aspect of the present disclosure.

Figure 11

[0051] Flowchart of a method for creating a subcutaneous pocket and implanting a device in the subcutaneous pocket, embodying an aspect of the present disclosure.

Figure 12A

[0052] Perspective view of an insertion tool embodying an aspect of the present disclosure.

Figure 12B

[0053] Perspective view of components within an insertion tool embodying an aspect of the present disclosure, with the tip of the dissection instrument set in the extended position and the cannula set in the retracted position.

Figure 12C

Figure 12D

[0054] Schematic diagram of components within an insertion tool embodying an aspect of the present disclosure, with the tip of the dissection instrument set in the retracted position and the cannula set in the retracted position.

Figure 12E

[0055] Schematic diagram of components within an insertion tool embodying an aspect of the present disclosure, with the tip of the dissection instrument set in the retracted position and the cannula set in the extended position.

Figure 13

[0056] Flowchart of a method for creating a subcutaneous pocket and implanting a device in the subcutaneous pocket, embodying an aspect of the present disclosure.

Mode for Carrying Out the Invention

[0028]

[0057] FIG. 1 is a schematic diagram showing an exemplary insertion tool 100 embodying aspects of the present disclosure. In some embodiments, the insertion tool 100 may be for creating a subcutaneous pocket 102 under the skin surface 104 and implanting a device 106 into the subcutaneous pocket 102. In some non-limiting embodiments, the device 106 may include an RFID chip. In some non-limiting embodiments, the device 106 may include sensors such as, but not limited to, a specimen sensor (e.g., a glucose sensor) and / or a temperature sensor. In some embodiments, the insertion tool 100 may include one or more of a handle 110, a cannula 120, a dissection instrument tip 125, a rod 130, and an actuator 140.

[0029]

[0058] In some embodiments, the cannula 120 may extend from the handle 110. In some embodiments, the cannula 120 may define a passage (e.g., a passage through which the device 106 can pass). In some embodiments, the cannula 120 and the dissection instrument tip 125 may be configured to create a subcutaneous pocket 102 under the skin surface 104 by inserting the dissection instrument tip 125 and the cannula 120 into an incision (not shown) made in the skin surface 104. In some embodiments, the cannula 120 may be configured to move axially between an extended position and a retracted position. In some embodiments, when the cannula 120 is set to the extended position, the cannula 120 and the dissection instrument tip 125 may be configured to create a subcutaneous pocket 102 under the skin surface 104. In some embodiments, movement of the cannula 120 to the retracted position may enable deployment of the device 106 from within the passage of the cannula 120 into the subcutaneous pocket 102. In some embodiments, when the cannula 120 is set to the extended position, a substantial portion of the cannula 120 may be disposed outside the handle 110. In some embodiments, when the cannula 120 is set to the retracted position, a part or all of the cannula 120 may be disposed within a cavity (not shown) of the handle 110.

[0030]

[0059] In some embodiments, the rod 130 can be (at least partially) disposed within the passageway of the cannula 120. In some embodiments, the movement of the cannula 120 between the extended position and the retracted position can be effected with respect to the rod 130, and the rod 130 can be configured to remain stationary relative to the handle 110 within the passageway of the cannula 120 as the cannula 120 moves between the extended position and the retracted position. In some embodiments, when the cannula 120 is set to the extended position, the rod 130 can be spatially separated from the distal end of the cannula 120 such that the passageway of the cannula 120 holds the device 106. In some embodiments, when the cannula 120 is moved from the extended position to the retracted position, the distal end of the cannula 120 can move toward the distal end of the rod 130, whereby the rod 130 acts as a backstop to push the device 106 into the passageway of the cannula 120 through the opening at the distal end of the cannula 120, at least partially out of the cannula 120, and at least partially into the subcutaneous pocket 120. In some embodiments, while or after retracting the cannula 120, the user may pull the handle 110 out of the pocket, leaving the device 106 within the subcutaneous pocket 120.

[0031]

[0060] In some embodiments, the actuator 140 can be disposed within the handle 110 and operably connected to the cannula 120. In some embodiments, the actuator 140 can be configured to move the cannula 120 between a retracted position and an extended position. In some embodiments, the actuator 140 can include a track 142 extending along the handle 110 and a slider knob 144 configured to slide along the track 142. In some embodiments, the movement of the slider knob 144 of the actuator 140 can move the cannula 120 between an extended position and a retracted position. In some embodiments, the cannula 120 can be configured to move from the extended position to the retracted position by sliding the slider knob 144 along the track 142 in a direction away from the cannula 120. In some embodiments, the cannula 120 can be configured to move from the retracted position to the extended position by sliding the slider knob 144 along the track 142 in a direction toward the cannula 120. In other embodiments (not shown), the actuator 140 can additionally or alternatively include other mechanisms, such as a spring, a solenoid, or a motor, to effect movement of the cannula 120.

[0032]

[0061] Figures 2A-7C show various exemplary embodiments of a cannula 120 and an inserter 130 that can be implemented using the insertion tool 100 according to the present disclosure.

[0033]

[0062] In some embodiments, as shown in FIGS. 2B and 2D, the cannula 120 may have a tubular shape and may define a passageway 202 that extends along the longitudinal axis of the cannula 120. In some embodiments, the cannula 120 may include a distal end 201 that defines an opening 203 to the passageway 202. In some embodiments, the distal end 201 of the cannula 120 can move axially away from the handle 110 when the cannula 120 is moving toward the extended position. In some embodiments, when the cannula 120 is moving toward the retracted position, the distal end 201 of the cannula 120 can move axially toward the handle 110. In some non-limiting embodiments, the cannula 120 may be composed of, for example but not limited to, stainless steel. In some other non-limiting embodiments, the cannula 120 may be composed of, for example but not limited to, polymer materials such as PC (polycarbonate), PPSU (polymer polyphenyl sulfone), PEEK (polyether ether ketone), PES (Polyethersulfone), POLY (polyarylamide)…

[0034]

[0063] In some embodiments, as shown in FIGS. 2A-2F, the dissection instrument tip 125 may comprise a sleeve 210 around at least a portion of the cannula 120. In some embodiments, the sleeve 210 may comprise one or more perforations 212 (e.g., one or more frangible portions or score lines) that define two or more portions 214 of the sleeve 210 proximate the distal end 201 of the cannula 120. In some embodiments, the one or more perforations 212 can be separated by pulling the sleeve 210 away from the distal end 201 of the cannula 120 and pulling towards the handle 110. In some embodiments, as shown in FIGS. 2C-2E, separation at the one or more perforations or frangible portions 212 can cause the portions 214 of the sleeve 210 to separate from each other. In some embodiments, the separated portions 214 of the sleeve 210 can expose an opening 203 within the passage 202 of the cannula 120. In some non-limiting embodiments, the sleeve 210 may be composed of a polymeric material such as, but not limited to, PU (polyurethane), PVC (polyvinyl chloride), PTFE (polytetrafluoroethylene), etc.

[0035]

[0064] In some embodiments, sleeve 210 may be operably connected to actuator 140. In some embodiments, sleeve 210 may be configured to be pulled along cannula 120 from a closed position to an open position by sliding slider knob 144 away from cannula 120 along track 142. In some embodiments, as shown in FIGS. 2A and 2B, when sleeve 210 is in the closed position, sleeve 210 may surround opening 203 of distal end 201 of cannula 120. In some embodiments, when sleeve 210 moves to the open position, sleeve 210 may be pulled away from distal end 201 of cannula 120 and toward handle 110. In some embodiments, as shown in FIGS. 2C-2F, when sleeve 210 is moved toward the open position, one or more score lines or frangible portions 212 may be separated and opening 203 of distal end 201 of cannula 120 may be exposed. In some embodiments, when sleeve 210 is pulled toward handle 110 of insertion tool 100, distal end 201 of cannula 120 may apply a sufficient amount of force against the sleeve to separate portion 214 of sleeve 210. In some embodiments, sleeve 210 may be configured to move toward the open position before cannula 120 moves toward the retracted position to ensure that distal end 201 of cannula 120 engages portion 214 of sleeve 210 with a sufficient amount of force to separate or break score line or frangible portion 212.

[0036]

[0065] In some embodiments, as shown in FIGS. 2B-2F, distal end 201 of cannula 120 may be blunt. However, in other embodiments, distal end 201 of cannula 120 may form other shapes (e.g., beveled shape) configured to create tunnels and pockets under the skin surface.

[0037]

[0066] In some embodiments, as shown in FIGS. 2B, 2D, and 2F, rod 130 can be at least partially disposed within passage 202 of cannula 120. In some embodiments, rod 130 can be configured to remain stationary (relative to handle 110) within passage 202 of cannula 120 as cannula 120 moves between a retracted position and an extended position. In some embodiments, as shown in FIG. 2B, when cannula 120 is set to the extended position, rod 130 may be spatially separated from distal end 201 of cannula 120 such that passage 202 of cannula 120 receives and / or holds device 106 proximate to distal end 201. In some embodiments, as shown in FIG. 2F, when cannula 120 is set to the retracted position, rod 130 can be disposed proximate to distal end 201 of cannula 120 or can protrude through distal end 201 of cannula 120. In some embodiments, when cannula 120 is moved from the extended position to the retracted position, rod 130 functions as a backstop and can at least partially push device 106 out of cannula 120 through opening 203 at distal end 201 of cannula 120.

[0038]

[0067] In some embodiments, rod 130 may be solid or hollow. In some embodiments, rod 130 may be constructed of a rigid material such as, but not limited to, polymeric materials such as stainless steel, ABS, polycarbonate, polyarylamide, and the like.

[0039]

[0068] In some embodiments, the insertion tool 100 can create a subcutaneous pocket 102 under the skin surface 104 by inserting the cannula 120 through an incision in the skin surface to an extended position at the tip 125 of the dissection instrument. In some embodiments, when the dissection instrument tip 125 and the cannula 120 are inserted into the incision and the dissection instrument tip 125 and the cannula 120 create the subcutaneous pocket 102, the sleeve 210 can be set to a closed position (as shown in FIGS. 2A and 2B), and the sleeve 210 can enclose the device 106 within the passage 202 of the cannula 120. In some embodiments, after creating the subcutaneous pocket 102, the sleeve 210 can be moved to an open position (e.g., by pulling the sleeve 210 toward the handle 110) where the opening 203 at the distal end 201 of the cannula 120 is exposed (as shown in FIGS. 2C and 2D). In some embodiments, after moving the sleeve 210 to the open position, the insertion tool 100 can embed the device 106 by moving the cannula 120 from the extended position toward the retracted position. In some embodiments, when the cannula 120 moves toward the retracted position, the rod 130 abuts the device 106 and functions as a backstop, propelling the device 106 through the opening 203 at the distal end 201 of the cannula 120, at least partially out of the cannula 120 and at least partially into the subcutaneous pocket 102 (as shown in FIGS. 2E and 2F). In some embodiments, after (or simultaneously with) moving the cannula 120 to the retracted position, the handle 110 can be used to withdraw the cannula 120 from the subcutaneous pocket 102, leaving the device 106 within the subcutaneous pocket 102.

[0040]

[0069] In some embodiments, as shown in FIGS. 3A-3C, the cannula 120 may have a beveled distal end 301. In some embodiments, the beveled distal end 301 may define an opening 303 into the passage 302 of the cannula 120. In some embodiments, the dissection instrument tip 125 may include a protrusion 308 that protrudes from the distal end 301 of the cannula 120. In some non-limiting embodiments, the protrusion 308 and the cannula 120 may be formed from a single piece of material.

[0041]

[0070] In some embodiments, as shown in FIGS. 3A-3C, the insertion tool 100 may further include a sleeve 310 around at least a portion of the cannula 120. In some embodiments, the sleeve 310 may surround the opening 303 at the distal end 301 of the cannula 120. In some embodiments, the sleeve 310 may define an opening 320 proximate to the distal end 301 of the cannula 120. In some embodiments, the dissection instrument tip 125 (e.g., the protrusion 308) may protrude through the opening 320 of the sleeve 310.

[0042]

[0071] In some embodiments, the sleeve 310 may include one or more perforations 312 (e.g., one or more frangible portions or score lines) that define two or more portions 314 of the sleeve 310 proximate to the distal end 301 of the cannula 120. In some embodiments, by pulling the sleeve 310 towards the handle 110, the one or more perforations 312 can be separated. In some embodiments, as shown in FIG. 3C, separation at the one or more perforations 312 may cause the portions 314 to separate from each other. In some embodiments, the separated portions 314 of the sleeve 310 can expose the opening 303 to the passage 302 of the cannula 120.

[0043]

[0072] In some embodiments, the sleeve 310 may be operably connected to the actuator 140. In some embodiments, the sleeve 310 may be configured to be pulled along the cannula 120 from a closed position to an open position by sliding the slider knob 144 away from the cannula 120 along the track 142. In some embodiments, as shown in FIGS. 3A and 3B, when the sleeve 310 is in the closed position, the sleeve 310 can surround the opening 303 of the distal end 201 of the cannula 120. In some embodiments, as shown in FIG. 3C, when the sleeve 310 moves to the open position, the sleeve 310 can be pulled towards the handle 110. In some embodiments, as shown in FIG. 3C, when the sleeve 310 is moved to the open position, one or more score lines 312 may be separated and the opening 203 of the distal end 301 of the cannula 120 may be exposed. In some embodiments, when the sleeve 310 is pulled towards the handle 110 of the insertion tool 100, the distal end 301 of the cannula 120 and the device 106 can apply a sufficient amount of force against the opening 320 of the sleeve 310 to separate the portion 314 of the sleeve 310. In some embodiments, the sleeve 310 is configured to move towards the open position before the cannula 120 moves towards the retracted position to ensure that the distal end 301 of the cannula 120 engages the portion 314 of the sleeve 310 with a sufficient amount of force to separate or break the score line or frangible portion 312.

[0044]

[0073] In some embodiments, as shown in FIG. 3A, the rod 130 may be at least partially disposed within the passage 302 of the cannula 120. In some embodiments, the rod 130 may be configured to remain stationary (relative to the handle 110) within the passage 302 of the cannula 120 as the cannula 120 moves between a retracted position and an extended position. In some embodiments, as shown in FIG. 3A, when the cannula 120 is set to the extended position, the rod 130 may be spatially separated from the distal end 301 of the cannula 120 such that the passage 302 of the cannula 120 can receive and / or hold the device 106 in proximity to the distal end 301. In some embodiments, when the cannula 120 is set to the retracted position, the rod 130 may be disposed in proximity to the distal end 301 of the cannula 120 or may project through the distal end 301 of the cannula 120. In some embodiments, by moving the cannula from the extended position to the retracted position, the device 106 can be pushed through the opening 303 at the distal end 301 of the cannula 120.

[0045]

[0074] In some embodiments, the insertion tool 100 can create a subcutaneous pocket 102 under the skin surface 104 by inserting the cannula 120 to an extended position using the dissection instrument tip 125 through an incision in the skin surface. In some embodiments, when the dissection instrument tip 125 and the cannula 120 are inserted into the incision and the dissection instrument tip 125 and the cannula 120 create the subcutaneous pocket 102, the sleeve 310 can be set to a closed position (as shown in FIGS. 3A and 3B) and the device 106 can be enclosed within the passageway 302 of the cannula 120. In some embodiments, after creating the subcutaneous pocket 102, the sleeve 310 can be moved to an open position (e.g., by pulling the sleeve 310 toward the handle 110) where the opening 303 at the distal end 301 of the cannula 120 is exposed (as shown in FIG. 3C). In some embodiments, after moving the sleeve 310 to the open position, the insertion tool 100 can implant the device 106 by moving the cannula 120 from the extended position toward the retracted position. In some embodiments, as the cannula 120 moves toward the retracted position, the rod 130 abuts the device 106 and functions as a backstop, pushing the device 106 through the opening 303 at the distal end 301 of the cannula 120, at least partially out of the cannula 120, and at least partially into the subcutaneous pocket 102. In some embodiments, after (or simultaneously with) moving the cannula 120 to the retracted position, the handle 110 can be used to withdraw the cannula 120 from the subcutaneous pocket 102, leaving the device 106 within the subcutaneous pocket 102.

[0046]

[0075] In some embodiments, as shown in FIGS. 4 and 5, the device 106 can support the dissection instrument tip 125 when the cannula 120 is in the extended position (e.g., a portion of the surface area of the device 106 can contact the dissection instrument tip 125). In some embodiments, the device 106 can support the dissection instrument tip 125 when the dissection instrument tip 125 and the cannula 120 in the extended position are inserted into the incision in the skin surface 104 to create the subcutaneous pocket 102. In some embodiments, as shown in FIG. 4, the front end 402 of the device 106 can support the sleeve 201 when the sleeve 201 is in the closed position surrounding the opening at the distal end of the cannula 120. In some non-limiting embodiments, as shown in FIG. 4, the device 106 can have a rounded edge approximating the shape of the sleeve 201 of the dissection instrument tip 125 that covers the blunt-shaped opening at the distal end of the cannula 210. In some alternative embodiments, as shown in FIG. 5, the front end 502 of the device 106 can support the sleeve when the sleeve is in the closed position surrounding the opening at the distal end of the cannula 120. In some non-limiting embodiments, as shown in FIG. 5, the device 106 may have a bevel edge approximating the bevel shape of the dissection instrument tip 125.

[0047]

[0076] Referring to FIGS. 6A and 6B, in some embodiments, the cannula 120 can include a bevel-shaped distal end 601. In some embodiments, the bevel-shaped distal end 601 can define an opening 613 into the passage 602 of the cannula 120. In some non-limiting embodiments, the cannula 120 can be operably connected to an actuator 140. In some embodiments, the cannula 120 can be configured to move from the extended position to the retracted position by sliding the slider knob 144 along the track 142 in a direction away from the cannula 120.

[0048]

[0077] In some embodiments, the dissection instrument tip 125 may include a flap 610 coupled to the cannula 120. In some embodiments, the flap 610 can pivot between a closed position and an open position. In some embodiments, when in the closed position, the flap 610 abuts against the distal end 601 of the cannula 120 and can surround the opening 613 at the distal end 601 of the cannula 120. In some embodiments, when in the open position, the flap 610 is spatially separated from the distal end 601 and can expose the opening 613 at the distal end 601 of the cannula 120. In some embodiments, the flap 610 may be configured to pivot from the closed position to the open position when a force is applied by an object such as a device 106 that moves axially relative to the flap 610.

[0049]

[0078] In some embodiments, as shown in FIGS. 6A and 6B, the flap 610 may include an extension 612 protruding from the inner surface of the flap 610. In some embodiments, when the flap 610 is in the closed position, the extension 612 engages with the inner surface of the cannula 120 so that the flap 610 can reliably surround the opening 613 at the distal end 601.

[0050]

[0079] In some embodiments, as shown in FIG. 6A, rod 130 can be at least partially disposed within passage 602 of cannula 120. In some embodiments, rod 130 can be configured to remain stationary (with respect to handle 110) within passage 613 of cannula 120 as cannula 120 moves between a retracted position and an extended position. In some embodiments, as shown in FIG. 6A, when cannula 120 is set to the extended position, rod 130 may be spatially separated from distal end 601 of cannula 120 such that passage 602 of cannula 120 can receive and / or hold device 106 in proximity to distal end 601. In some embodiments, when cannula 120 is set to the retracted position, rod 130 can be disposed in proximity to distal end 601 or can project through distal end 601 of cannula 120. In some embodiments, as cannula 120 moves from the extended position to the retracted position, rod 130 can push device 106 through opening 613 at distal end 601 of cannula 120.

[0051]

[0080] In some embodiments, the insertion tool 100 can create a subcutaneous pocket 102 under the skin surface 104 by inserting the cannula 120 through an incision in the skin surface to an extended position at the tip 125 of the dissection instrument. In some embodiments, the dissection instrument tip 125 and the cannula 120 are inserted into the incision, and the flap 610 may be in the closed position (as shown in FIG. 6A) when the dissection instrument tip 125 and the cannula 120 create the subcutaneous pocket 102. In the closed position, the flap 610 can enclose the device 106 within the passage 602 of the cannula 120. In some embodiments, after creating the subcutaneous pocket 102, the insertion tool 100 can implant the device 106 by moving the cannula 120 toward the retracted position. In some embodiments, when the cannula 120 moves toward the retracted position, the rod 130 can abut against the device 106 and press the device 106 against the flap 610. In some embodiments, when the device 106 is pressed against the flap 610, the flap 610 pivots from the closed position to the open position (as shown in FIG. 6B). In some embodiments, the device 106 can then be at least partially extruded from the cannula 120 and at least partially pushed into the subcutaneous pocket 102 through the opening 613 at the distal end 601 of the cannula 120. In some embodiments, after (or simultaneously with) moving the cannula 120 to the retracted position, the handle 110 can be used to withdraw the cannula 120 from the subcutaneous pocket 102, leaving the device 106 within the subcutaneous pocket 102.

[0052]

[0081] In some embodiments, as shown in FIGS. 7A-7C, cannula 120 may define a passageway 702 that extends along its longitudinal axis. In some non-limiting embodiments, cannula 120 is operably connected to actuator 140. In some embodiments, cannula 120 may be configured to move from an extended position to a retracted position by sliding slider knob 144 away from cannula 120 along track 142. In some embodiments, cannula 120 may include a distal end 704 that defines an opening 703 into passageway 702. In some embodiments, cannula 120 may be configured to hold and retain at least a portion of device 106 within passageway 702 proximate to the open distal end 704 when set to the extended position. In some embodiments, cannula 120 may include one or more flexible fingers 706 disposed along cannula 120. In some embodiments, one or more flexible fingers 706 may be configured to hold device 106 by bending toward the longitudinal axis of cannula 120. In some embodiments, flexible fingers 706 may be defined by a pair of parallel slits cut along cannula 120, and each flexible finger 706 may include a strip of cannula 120 defined by the pair of slits.

[0053]

[0082] In some embodiments, as shown in FIGS. 7A - 7C, the dissection instrument tip 125 can be integrally connected to the device 106. In some embodiments, the dissection instrument tip 125 may be a conical protrusion 710 disposed at the front end of the device 106. In some embodiments, when the device 106 is partially maintained within the passage 702 of the cannula 120, the protrusion 710 of the device 106 protrudes from the distal end 704 of the dissection rod 120. In some embodiments, the protrusion 710 may include one or more shoulders 712 that radially protrude from the side surface of the device 106. In some embodiments, when the device 106 can be maintained within the passage 702 of the cannula 120, the distal end 702 of the cannula 120 can abut against the shoulder 712, thereby ensuring that the protrusion 710 extends a predetermined length from the distal end 704.

[0054]

[0083] In some embodiments, as shown in FIGS. 7A and 7B, the rod 130 can be at least partially disposed within the passage 702 of the cannula 120. In some embodiments, the rod 130 can be configured to remain stationary (with respect to the handle 110) within the passage 702 of the cannula 120 as the cannula 120 moves between a retracted position and an extended position. In some embodiments, as shown in FIG. 7A, when the cannula 120 is set to the extended position, the rod 130 can be spatially separated from the distal end 704 of the cannula 120 such that the passage 702 of the cannula 120 can receive at least a portion of the device 106 proximate to the distal end 704. In some embodiments, when the cannula 120 is set to the retracted position, the rod 130 can be disposed proximate to the distal end 704 or can protrude through the distal end 704 of the cannula 120. In some embodiments, when the cannula 120 is moved from the extended position to the retracted position, the rod 130 can at least partially push the device 106 out of the cannula 120 through the opening 703 at the distal end 704 of the cannula 120.

[0055]

[0084] In some embodiments, as shown in FIG. 7C, cannula 120 can further include one or more ports 705 for introducing a hydrating fluid (e.g., saline) into passageway 702. In some embodiments, the hydrating fluid can be introduced into one or more ports 705 while device 106 is held within passageway 702 of cannula 120. In some embodiments, the hydrating fluid can hydrate (or at least initiate hydration of) at least a portion of device 106 prior to implantation of device 106. For example, for a non-limiting embodiment of device 106 that is an analyte sensor, the analyte sensor can include an analyte indicator that includes a hydrogel, and the hydrating fluid can hydrate (or at least initiate hydration of) at least the analyte indicator of the sensor prior to insertion. In some non-limiting embodiments, device 106 may require hydration before it can operate properly. Thus, in some embodiments, the hydrating fluid within cannula 120 can shorten or eliminate the time required for device 106 to be implanted in the body before device 106 can operate properly.

[0056]

[0085] In some embodiments, the insertion tool 100 can create a subcutaneous pocket 102 under the skin surface 104 by inserting the cannula 120 through an incision in the skin surface to an extended position at the tip 125 of the dissection instrument. In some embodiments, when the cannula 120 is inserted into the incision and the protrusion 710 and the cannula 120 create the subcutaneous pocket 102, the device 106 can be partially retained within the passageway 702 of the cannula 120 by the protrusion 710 that projects away from the distal end 704 of the cannula 120. In some embodiments, after creating the subcutaneous pocket 102, the insertion tool 100 can implant the device 106 by moving the cannula 120 toward the retracted position. In some embodiments, when the cannula 120 moves toward the retracted position, the rod 130 abuts against the device 106 and functions as a backstop, pushing the device 106 through the opening 703 at the distal end 701 of the cannula 120, at least partially out of the cannula 120 and at least partially into the subcutaneous pocket 102 (as shown in FIG. 7B). In some embodiments, after (or simultaneously with) moving the cannula 120 to the retracted position, the handle 110 can be used to withdraw the cannula 120 from the subcutaneous pocket 102, leaving the device 106 within the subcutaneous pocket 102.

[0057]

[0086] FIGS. 8A and 8B show an exemplary insertion tool 800 for creating a subcutaneous pocket 102 under the skin surface 104 and implanting the device 106 into the subcutaneous pocket 102. In some embodiments, the insertion tool 800 can include a handle 810, a tunneling tube 820, a dissection instrument 830, an inserter 840, and one or more actuators (not shown). In some embodiments, the handle 810 can define a cavity 811 therein. In some embodiments, the tunneling tube 820 can extend from a first end 812 of the handle 810 and can define a passageway 822 that opens into the cavity 811 of the handle 810.

[0058]

[0087] In some embodiments, the tunneling tube 820 can be configured to move axially between an extended position and a retracted position. In some embodiments, when the tunneling tube 820 is set to the extended position, the tunneling tube 820 and the dissection instrument 830 can be configured to create a subcutaneous pocket 102 under the skin surface 104. In some embodiments, when the tunneling tube 820 is moved to the retracted position, the tunneling tube 820 and the inserter 840 can be configured to deploy the device 106 into the subcutaneous pocket 102. In some embodiments, when the tunneling tube 820 is set to the extended position, a substantial portion of the tunneling tube 820 can be disposed outside the handle 110. In some embodiments, when the tunneling tube 820 is set to the retracted position, a part or all of the tunneling tube 820 can be disposed within the cavity 811 of the handle 810.

[0059]

[0088] In some embodiments, the dissection instrument 830 can include a first rod 834 at least partially disposed within the cavity 811 of the handle 810. In some embodiments, the first rod 834 may be rigid. However, this is not essential, and in some alternative embodiments, the first rod 834 may be flexible. In some embodiments, the first rod 834 may be composed of a polymeric material such as nylon, polypropylene, or polyvinyl chloride. In some embodiments, the dissection instrument tip 832 can be coupled to the distal end of the first rod 834. In some embodiments, the dissection instrument tip 832 and the first rod 834 can be configured to move between an extended position and a retracted position. FIGS. 8A and 8B respectively show the dissection instrument tip 832 and the first rod 834 in the extended position and the retracted position. In some non-limiting embodiments, as shown in FIG. 8A, when in the extended position, the dissection instrument tip 832 can protrude from the distal end of the tunneling tube 820. In some embodiments, the dissection instrument tip 832 can be configured to create a subcutaneous pocket 102 under the skin surface 104. In some embodiments, as shown in FIG. 8B, when set to the retracted position, the dissection instrument tip 832 can be disposed within the cavity 811 of the handle 810.

[0060]

[0089] In some embodiments, the first rod 834 may be operably connected to an actuator, and the actuator may be configured to move the first rod 834 and the dissection instrument tip 832 between an extended position and a retracted position. In some embodiments, the actuator may be configured to move the dissection instrument tip 832 out of the tunneling tube 820 and into the cavity 811. In some embodiments, the actuator may be a slider or lever connected to the first rod 834. In some embodiments, the actuator may be a spring mechanism connected to the first rod 834 for advancing and retracting the first rod 834. Some embodiments include an actuator configured to move the first rod 834 and the dissection instrument tip 832 between an extended position and a retracted position, but this actuator is not essential. In some alternative embodiments, the user may move the first rod 834 and the dissection instrument tip 832 from the extended position shown in FIG. 8A to the retracted position shown in FIG. 8B by directly pulling the first rod 832.

[0061]

[0090] In some embodiments, the inserter 840 may include a second rod 844 that is at least partially disposed within the cavity 811 of the handle 810. In some embodiments, the second rod 844 may be rigid. However, this is not essential, and in some alternative embodiments, the second rod 844 may be flexible. In some embodiments, the inserter 840 may include a cannula 842. In some embodiments, the cannula 842 may include a first end 842A configured to hold and release the device 106. In some embodiments, the cannula 842 may include a second end 842B coupled to the distal end of the second rod 844. In some embodiments, the second rod 844 may be configured to move along the cavity 811 of the handle 810. In some embodiments, the cannula 842 may be configured to move between a retracted position and an extended position. In some embodiments, the cannula 842 may be configured to slide along the second rod 844 toward the retracted position as the tunneling tube 820 moves toward the retracted position.

[0062]

[0091] Figures 8A and 8B show the cannula 842 in its retracted and extended positions, respectively. In some embodiments, as shown in Figure 8A, when in the retracted position, the cannula 842 may be disposed within the cavity 811 of the handle 810. In some embodiments, as shown in Figure 8B, when in the extended position, the cannula 842 may be at least partially disposed within the passage 822 of the tunneling tube 820. In some embodiments, the tunneling tube 820 can hold the cannula 842 in its extended position. In some embodiments, when the cannula 842 is in its extended position and at least partially disposed within the tunneling tube 820, the tunneling tube 820 can axially retract towards the handle 810 and slide the cannula 842 back towards the handle 810. In some embodiments, when the cannula 842 retracts into the cavity 811 of the handle 810 together with the tunneling tube 820, the second rod 844 remains in the extended position and abuts against the device 106 to at least partially push the device 106 out of the cannula 842 and the tunneling tube 820 and at least partially push it into the subcutaneous pocket 102.

[0063]

[0092] In some embodiments, the second rod 844 may be operably connected to an actuator, which may be configured to move the second rod 844, the cannula 842, and the tunneling tube 820 between a retracted position and an extended position. In some embodiments, the actuator configured to move the second rod 844, the cannula 842, and the tunneling tube 820 between a retracted position and an extended position may be the same actuator configured to move the first rod 834 and the dissection instrument tip 832 between a retracted position and an extended position. In some embodiments, the actuator may be a slider knob (not shown) configured to slide along a track (not shown) disposed along the handle 810. In some embodiments, the actuator may include a fork (not shown) extending from the slider knob and having a plurality of prongs connected to the first rod 834 and the second rod 844. In some embodiments, the actuator may include a catch mechanism (not shown), such as a strut, for holding the second rod 844 in the extended position while the actuator moves the tunneling tube 820 and the cannula 842 toward the retracted position. In some alternative embodiments, a first actuator may be configured to move the second rod 844 and the cannula 842 between a retracted position and an extended position, and a separate second actuator may be configured to move the first rod 834 and the dissection instrument tip 832 between a retracted position and an extended position.

[0064]

[0093] In some embodiments, the insertion tool 800 can create a subcutaneous pocket 102 under the skin surface 104 by setting the dissection instrument 830 to the extended position (as shown in FIG. 8A) and inserting the tunneling tube 820 with the dissection instrument tip 832 protruding from the tunneling tube 820 through an incision in the skin surface. In some embodiments, after creating the subcutaneous pocket 102, the dissection instrument tip 832 and the first rod 834 can be moved from their extended positions to their retracted positions. In some embodiments, the second rod 844 and the cannula 842 can then be moved from the retracted position towards the extended position such that the cannula 842 (in which the device 106 is held) is at least partially disposed within the tunneling tube 820. In some embodiments, with the cannula 842 at least partially disposed within the tunneling tube 820, the tunneling tube 820 can be retracted towards the handle 810, sliding the cannula 842 along the second rod 844 and at least partially into the cavity 811 of the handle 810. In some embodiments, when the cannula 842 retracts into the cavity 811 of the handle 810 together with the tunneling tube 820, the second rod 844 remains in the extended position (e.g., using the catch mechanism of the actuator 950) and abuts against the device 106 to at least partially push the device 106 out of the cannula 842 and the tunneling tube 820. In some embodiments, the tunneling tube 820 can be pulled out of the subcutaneous pocket 102 using the handle 810, leaving the device 106 in the subcutaneous pocket 102. In some embodiments, one or more of the dissection instrument tip 832, the first rod 834, the cannula 842, and the second rod 844 can be moved while keeping the tunnel tube 820 disposed within the subcutaneous pocket 102.

[0065]

[0094] Figures 9A and 9B show an exemplary insertion tool 900 for creating a subcutaneous pocket 102 under the skin surface 104 and implanting a device 106 into the subcutaneous pocket 102. In some embodiments, the insertion tool 900 includes a handle 910, a tunneling tube 920, a dissection instrument 930, an inserter 940, and an actuator 950.

[0066]

[0095] In some embodiments, the insertion tool 900 may include one or more of the same features as the embodiment of the insertion tool 800 shown in FIGS. 8A and 8B. For example, the tunneling tube 920 may be configured to move between an extended position where a dissection instrument 930 is used to create the subcutaneous pocket 102 and a retracted position where an inserter 940 is used to place the device 106 into the subcutaneous pocket 102. In some embodiments, the dissection instrument 930 may include a first rod 934 configured to move along a cavity 911 of the handle 910 and a dissection instrument tip 932 coupled to the distal end of the first rod 934. In some embodiments, the inserter 940 may include a second rod 944 configured to move along a cavity 911 of the handle 910 and a cannula 942 configured to hold the device 106 at a first end 942A and coupled to the second rod 944 at a second end 942B.

[0067]

[0096] In some embodiments, as shown in FIGS. 9A and 9B, the dissection instrument 930 may be configured to pivot from an operating position disposed along a first axis A defined by the tunneling tube 920 to an idle position disposed along a second axis B. In some embodiments, the second axis B may extend at an acute angle θ AB (e.g., 10°) with respect to the first axis A. In some embodiments, the inserter 940 may be configured to pivot from an idle position disposed along a third axis C to an operating position disposed along the first axis A. In some embodiments, the third axis C may extend at an acute angle θ AC (e.g., 10°) with respect to the first axis A.

[0068]

[0097] In some embodiments, as shown in FIGS. 9A and 9B, the insertion tool 900 can further include a hinge 960. In some non-limiting embodiments, the hinge 960 may be disposed on the handle 910. In some embodiments, the hinge 960 is disposed within the cavity 911 and includes a first arm 962 configured to pivot about an axis defined by the hinge 960 from an operating position extending along a first axis A to an idle position extending along a second axis B. In some embodiments, the hinge 960 is disposed within the cavity 911 and includes a second arm 964 configured to pivot about an axis defined by the hinge 960 from an idle position extending along a third axis C to an operating position extending along the first axis A.

[0069]

[0098] In some embodiments, the first arm 962 can define a passage, and the dissection instrument tip 932 and the first rod 934 can be disposed within the passage of the first arm 962. In some embodiments, the dissection instrument 930 can be configured to move between an operating position and an idle position when the first arm 962 pivots about the hinge 960. In some embodiments, the dissection instrument tip 932 and the first rod 930 can be configured to move between a retracted position and an extended position along the passage of the first arm 962 when the first arm 962 is set to the operating position extending along the first axis A. In some embodiments, the dissection instrument tip 932 and the first rod 930 can be configured to remain stationary in the retracted position when the first arm 962 is set to the idle position extending along the second axis B.

[0070]

[0099] In some embodiments, the second arm 964 can define a passageway, and the cannula 942 and the second rod 944 can be disposed within the passageway of the second arm 964 such that the inserter 940 moves between the idle position and the operative position as the second arm 964 pivots about the hinge 960. In some embodiments, the cannula tube 942 and the second rod 944 can be configured to move along the passageway of the second arm 964 and be set to an operative position extending along the first axis A. In some embodiments, the cannula tube 942 and the second rod 944 can be configured to remain stationary in a retracted position when the second arm 964 is set to an idle position extending along the third axis C.

[0071]

[0100] In some embodiments, the insertion tool 900 includes a pivot actuator 962 operably connected to the dissection instrument 930 and the inserter 940 and can cause the dissection instrument 930 and the inserter 940 to pivot between an idle position and an operative position. In some embodiments, the pivot actuator 962 can include, for example, but not limited to, a twist knob or a slider. In other embodiments (not shown), the insertion tool 900 can include other internal mechanisms (e.g., a spring-loaded device) to move the dissection instrument 930 and the inserter 940 between the idle position and the operative position.

[0072]

[0101] In some embodiments, the actuator 950 can be disposed within the handle 910 and operably connected to the tunneling tube 920, the dissection instrument 930, and the inserter 940. In some embodiments, the actuator 950 can be configured to selectively force the tunneling tube 920, the dissection instrument 930, and the inserter 940 to move between a retracted position and an extended position. In some embodiments, the actuator 950 can include a track (not shown) extending along the handle 910 and a slider knob 951 configured to slide along the track. In some embodiments, the actuator 950 can include a fork (not shown) extending from the slider knob 951 and configured to removably connect to the dissection instrument 930 and the inserter 940 when pivoted to an actuated position. In some embodiments, the actuator 950 can include a catch mechanism (not shown), such as a strut, for holding the second rod 944 in an extended position while the actuator 950 moves the tunneling tube 920 and the cannula 942 toward the retracted position.

[0073]

[0102] In some embodiments, the insertion tool 900 can create a subcutaneous pocket 102 under the skin surface 104 by first setting the dissection instrument 930 to the operative position (e.g., using the pivot actuator 962) and sliding the dissection instrument tip 932 and the first rod 934 to the extended position (as shown in FIG. 9A) (e.g., using the actuator 950). In some embodiments, the subcutaneous pocket 102 can be created by inserting the tunneling tube 920 with the dissection instrument tip 932 protruding from the tunneling tube 920 through an incision in the skin surface. In some embodiments, after creating the subcutaneous pocket 102, the dissection instrument tip 932 and the first rod 934 can be moved from their extended positions to their retracted positions. In some embodiments, the dissection instrument 930 in the retracted position may be pivoted from the operative position along the first axis A to the idle position along the second axis B, and the inserter 940 can be pivoted from the idle position along the third axis C to the operative position along the first axis A (e.g., using the pivot actuator 962). In some embodiments, then, the second rod 944 of the inserter 940 and the cannula 942 in the operative position can be moved from the retracted position toward the extended position such that the cannula 942 (in which the device 106 is held) is at least partially disposed within the tunneling tube 920 (e.g., using the actuator 950). In some embodiments, with the cannula 942 at least partially disposed within the tunneling tube 920, the tunneling tube 920 can be retracted toward the handle 910 (e.g., using the actuator 950), sliding the cannula 942 along the second rod 944 and at least partially into the cavity 911 of the handle 910. In some embodiments, when the cannula 942 retracts into the cavity 911 of the handle 910 with the tunneling tube 920, the second rod 944 remains in the extended position (e.g., using the catch mechanism of the actuator 950), abuts against the device 106, functions as a backstop, and can at least partially push the device 106 out of the cannula 942 and the tunneling tube 920.In some embodiments, after (or simultaneously with) at least partially retracting the tunneling tube 920 into the cavity 911 of the handle 910, the tunneling tube 920 can be withdrawn from the subcutaneous pocket 102 using the handle 910, and the device 106 can be left in the subcutaneous pocket 102. In some embodiments, while the tunneling tube 920 remains disposed within the subcutaneous pocket 102, one or more of the dissection instrument tip 932, the first rod 934, the cannula 942, the second rod 944, the actuator 950, and the pivot actuator 962 can be moved.

[0074]

[0103] FIG. 10 shows an exemplary insertion tool 1000 that can include one or more guide prongs 1002 extending from a first end of a handle 110. In some embodiments, one or more guide prongs 1002 can be configured to limit the depth to which the dissection rod 120 can create the subcutaneous pocket 102. In some embodiments, the dissection rod 120 can extend further from the end of the handle 110 than one or more guide prongs 1002.

[0075]

[0104] In some embodiments, all configurations of the insertion tools 100, 800, 900, and 1000 described herein can be disposed within a handle and can include a loading port in communication with a cannula for introducing a hydrating fluid (e.g., saline) into the cannula. In some embodiments, the hydrating fluid can hydrate (or at least initiate hydration of) at least a portion of the device 106 (e.g., the analyte indicator or hydrogel of the device 106) prior to implantation of the device 106.

[0076]

[0105] FIG. 11 is a flowchart showing a method 1100 of creating a subcutaneous pocket under the skin surface and implanting a device embodying aspects of the present disclosure. In some embodiments, the insertion tools 100, 800, 900, and 1000 described above with respect to FIGS. 1 - 10 can be used to create the subcutaneous pocket and implant the device according to the method described in FIG. 11.

[0077]

[0106] In some embodiments, method 1100 can include a step 1101 of loading a device into a cannula passage extending from a handle of an insertion tool.

[0078]

[0107] In some embodiments, method 1100 can include a step 1102 of inserting a cannula of the insertion tool and a dissection instrument tip disposed at a distal end of the cannula into an incision in the skin surface such that the dissection instrument tip and the cannula create a subcutaneous pocket.

[0079]

[0108] In some embodiments, method 1100 can include a step 1103 of moving the cannula from an extended position to a retracted position such that a rod disposed along the cannula passage pushes the device through an opening at the distal end of the cannula, out of the cannula passage, and into the subcutaneous pocket.

[0080]

[0109] In some embodiments, method 1100 can further include a step of pulling a sleeve around a distal end of the cannula to surround an opening at the distal end of the cannula after loading the device into the passage and before inserting the cannula and the dissection instrument tip. In some embodiments, method 1100 can further include a step of pulling a sleeve received around the cannula toward the handle to expose an opening at the distal end of the cannula before the loading step.

[0081]

[0110] In some embodiments, method 1100 may further include moving the cannula from the extended position to the retracted position using an actuator disposed on the handle. In some embodiments, method 1100 may further include pulling the cannula out of the subcutaneous pocket.

[0082]

[0111] In some embodiments, method 110 may further include pulling a sleeve along the cannula from a closed position where the sleeve surrounds the opening at the distal end of the cannula to an open position where the sleeve exposes the opening at the distal end of the cannula.

[0083]

[0112] In some embodiments, the insertion tool may further include a flap that covers the opening at the distal end of the cannula. In some embodiments, method 1100 may further include moving the cannula from the extended position to the retracted position, spatially separating the flap from the distal end of the cannula, and exposing the opening at the distal end of the cannula.

[0084]

[0113] Figures 12A - 12E show an exemplary insertion tool 1200 for creating a subcutaneous pocket 102 under the skin surface 104 and implanting a device 106 into the subcutaneous pocket 102. In some embodiments, the insertion tool 1200 includes a handle 1210, a tunneling tube 1220, a dissection instrument 1230, an inserter 1240, and an actuator 1250.

[0085]

[0114] In some embodiments, the insertion tool 1200 may include one or more of the same features as the embodiments of the insertion tools 800 and 900 shown in FIGS. 8A-9B. For example, the tunneling tube 1220 may be configured to move between an extended position for creating the subcutaneous pocket 102 using the dissection instrument 1230 and a retracted position for placing the device 106 into the subcutaneous pocket 102 using the inserter 1240. In some embodiments, the dissection instrument 1230 may include a first rod 1234 configured to move along the cavity 1211 of the handle 1210 and a dissection instrument tip 1232 coupled to the distal end of the first rod 1234. In some embodiments, the inserter 1240 may include a second rod 1244 configured to move along the cavity 1211 of the handle 1210 and a cannula 1242 configured to hold the device 106 at a first end and be coupled to the second rod 1244 at a second end.

[0086]

[0115] In some embodiments, the dissection instrument 1230 may be configured to move from an operating position where the longitudinal axis of the dissection instrument 1230 coincides with the longitudinal axis of the tunneling tube 1220 to an idle position where the longitudinal axis of the dissection instrument 1230 does not coincide with (e.g., is shifted away from and parallel to) the longitudinal axis of the tunneling tube 1220. In some embodiments, the inserter 1240 may be configured to move from an idle position where the longitudinal axis of the inserter 1240 does not coincide with (e.g., is shifted away from and parallel to) the longitudinal axis of the tunneling tube 1220 to an operating position where the longitudinal axis of the inserter 1240 coincides with the longitudinal axis of the tunneling tube 1220.

[0087]

[0116] In some embodiments, the insertion tool 1200 may include a hinge 1260. In some non-limiting embodiments, the hinge 1260 may be disposed on the handle 1210. In some embodiments, the dissection instrument 1230 and the inserter 1240 may be configured to rotate about the hinge 1260. In some embodiments, the dissection instrument 1230 may be configured to rotate from its operative position to its idle position as the inserter 1240 rotates from its idle position to its operative position.

[0088]

[0117] In some embodiments, the insertion tool 1200 may include a rotational actuator operably connected to the dissection instrument 1230 and the inserter 1240 to rotate the dissection instrument 1230 and the inserter 1240. In some embodiments, the rotational actuator may include, for example but not limited to, a spring. In some embodiments, the rotational actuator may be configured to automatically rotate the dissection instrument 1230 from its operative position to its idle position and the inserter 1240 from its idle position to its operative position when the actuator 1250 moves to the retracted position. In some alternative embodiments, the rotational actuator may include, for example but not limited to, a twist knob or a slider, and the rotational actuator may be configured to manually rotate the dissection instrument 1230 and the inserter 1240.

[0089]

[0118] In some embodiments, the actuator 1250 can be disposed within the handle 1210 and can be operably connected to one or more of the tunneling tube 1220, the dissection instrument 1230, and the inserter 1240. In some embodiments, the actuator 1250 can be configured to selectively force one or more of the tunneling tube 1220, the dissection instrument 1230, and the inserter 1240 to move between a retracted position and an extended position. In some embodiments, the actuator 1250 can include a track extending along the handle 1210 and a slider knob 1251 configured to slide along the track. In some embodiments, the actuator 1250 can include a gear 1252 that engages teeth. In some embodiments, the gear 1252 can enable a relatively small movement of the slider knob 1251 to cause a relatively large movement of the dissection instrument 1230 and / or the inserter 1240.

[0090]

[0119] In some embodiments, the insertion tool 1200 can create a subcutaneous pocket 102 under the skin surface 104 with the dissecting instrument 1230 in the operative position and the dissecting instrument tip 932 and the first rod 1234 in the extended position (as shown in FIGS. 12B and 12C). In some embodiments, the subcutaneous pocket 102 can be created by inserting the tunneling tube 1220 together with the dissecting instrument tip 1232 protruding from the tunneling tube 1220 through an incision in the skin surface. In some embodiments, as shown in FIG. 12D, after creating the subcutaneous pocket 102, the dissecting instrument tip 1232 and the first rod 1234 can be moved from their extended positions to their retracted positions (e.g., using the actuator 1250). In some embodiments, the dissecting instrument 1230 in the retracted position can rotate from the operative position on the longitudinal axis of the tunneling tube 1220 to the idle position, and the inserter 1240 can rotate from the idle position to the operative position on the longitudinal axis of the tunnel tube 1220. In some embodiments, then, the second rod 1244 of the inserter 1240 and the cannula 1242 in the operative position can be moved from the retracted position towards the extended position (e.g., using the actuator 1250) such that the cannula 1242 (in which the device 106 is held) is at least partially disposed within the tunneling tube 1220. In some embodiments, with the cannula 1242 at least partially disposed within the tunneling tube 1220, the tunneling tube 1220 can be retracted towards the handle 1210 (e.g., using the actuator 950), sliding the cannula 1242 along the second rod 1244 and at least partially into the cavity 1211 of the handle 1210. In some embodiments, when the cannula 1242 retracts into the cavity 1211 of the handle 1210 together with the tunneling tube 1220, the second rod 1244 can remain in the extended position (e.g., using the catch mechanism of the actuator 1250), abutting against the device 106 and functioning as a backstop to at least partially push the device 106 out of the cannula 1242 and the tunneling tube 1220 (as shown in FIG. 12E).In some embodiments, the insertion tool 1200 may include a mechanism (e.g., a ratchet) that allows only forward movement (and prevents backward movement) of the slider knob 1251 of the actuator 1250 after the inserter 1240 has been rotated to the operating position such that the second rod 1244 and the cannula 1242 of the inserter 1240 can only move from the retracted position towards the extended position.

[0091]

[0120] In some embodiments, after (or simultaneously with) at least partially retracting the tunneling tube 1220 into the cavity 1211 of the handle 910, the handle 1210 can be used to pull the tunneling tube 1220 out of the subcutaneous pocket 102, leaving the device 106 in the subcutaneous pocket 102. In some embodiments, one or more of the dissection instrument tip 1232, the first rod 1234, the cannula 1242, the second rod 1244, the actuator 1250, and the rotary actuator can be moved while keeping the tunneling tube 1220 disposed within the subcutaneous pocket 102.

[0092]

[0121] In some embodiments, as shown in FIGS. 12A - 12E, the insertion tool 1200 may include one or more guide prongs 1202 extending from the first end of the handle 1210. In some embodiments, the one or more guide prongs 1202 may be configured to limit the depth to which the dissection rod 1220 can create the subcutaneous pocket 102. In some embodiments, the dissection rod 1220 can extend further from the end of the handle 110 than the one or more guide prongs 1202.

[0093]

[0122] In some embodiments, the insertion tool 1200 includes a loading port disposed within the handle 1210 and in communication with the cannula 1242 for introducing a hydrating fluid (e.g., saline) into the cannula 1242. In some embodiments, the hydrating fluid can hydrate (or at least initiate hydration of) at least a portion of the device 106 (e.g., the analyte indicator or hydrogel of the device 106) prior to implantation of the device 106. In some embodiments, the cannula 1242 can function as a hydration cavity within the tool 1200 that can be filled by a luer lock tube into a cavity within the cannula 1242 that holds the device 106. In some embodiments, the cavity may be sealed when hydrating the device 106.

[0094]

[0123] In some embodiments, the blunt dissection tool function of the tool 1200 can be utilized to create a subcutaneous tunnel with the dissection tool tip 1232 and the tunneling tube 1220 (e.g., a steel tunneling tube). In some embodiments, the insertion device 1200 can form a subcutaneous tunnel while the device 106 is hydrating. In some embodiments, after the subcutaneous tunnel is created, the dissection tool 1230 can be retracted using the slider 1251 of the actuator 1250, and then a rotational actuator (e.g., a spring) can align the device 106 within a bore used for ejection. Next, by sliding the thumb slider forward, the device 106 can be deployed and the tool 1200 can be withdrawn from the insertion site.

[0095]

[0124] In some embodiments, the insertion tool 1200 can be used as a fitting component for a luer lock tube that fills the cavity of the cannula 1242 in which the device 106 is present. In some embodiments, the rotary actuator may be a spring-loaded feature that aligns the device 106 with the tunneling tube 1230. In some embodiments, the insertion tool 1200 can include one or more depth guides 1202. In some embodiments, the insertion tool 1200 may have different usage sequences triggered from the slider knob 1251.

[0096]

[0125] In some embodiments, a method of creating a subcutaneous pocket 102 under the skin surface 104 and implanting the device 106 into the subcutaneous pocket 102 using the insertion tool 1200 may include a first step of using the insertion tool 1200 with the dissecting instrument tip 932 and the first rod 934 in the extended position to create the subcutaneous pocket 102. In some embodiments, during the first step, the luer lock tube may seal the device 106 for hydration. In some embodiments, the method may include a second step of retracting the slider knob 1251 to move the dissecting instrument 1230 to the retracted position. In some embodiments, the second step may include rotating the dissecting instrument 1230 from the operating position to the idle position and rotating the inserter 1240 from the idle position to the operating position. In some embodiments, the method may include a third step of pushing the slider knob 1251 forward, which may push the device 106 into the subcutaneous pocket 102 created in the first step.

[0097]

[0126] FIG. 13 is a flowchart showing a method 1300 of creating a subcutaneous pocket under the skin surface and implanting a device into the subcutaneous pocket, embodying aspects of the present disclosure. In some embodiments, the subcutaneous pocket can be created using the insertion tool 1200 described above with FIGS. 12A - 12E, and the device can be implanted according to the process 1300 described with FIG. 13.

[0098]

[0127] In some embodiments, process 1300 may include step 1302 of using dissecting instrument 1230 of insertion tool 1200 in a state where dissecting instrument 1230 is in an extended position in which blunt tip 1232 of dissecting instrument 1230 protrudes from the distal end of tunneling tube 1220 to form subcutaneous pocket 102. In some embodiments, tunneling tube 1220 may extend from a first end of handle 1210 of insertion tool 1200 and define a passage that opens into cavity 1211 of handle 1210.

[0099]

[0128] In some embodiments, process 1300 may include step 1304 of moving dissecting instrument 1230 from the extended position to a retracted position in which blunt tip 1232 is disposed within the cavity of handle 1210.

[0100]

[0129] In some embodiments, process 1300 may include step 1306 of rotating dissecting instrument 1230 from an operating position disposed on the longitudinal axis of tunneling tube 1220 to an idle position disposed away from the longitudinal axis of tunneling tube 1220.

[0101]

[0130] In some embodiments, process 1300 may include step 1308 of using inserter 1240 of insertion tool 1200 to hold device 106 within the passage of cannula 1242 of inserter 1240. In some embodiments, inserter 1240 may hold a hydrating fluid within the passage of cannula 1242.

[0102]

[0131] In some embodiments, process 1300 may include step 1310 of rotating inserter 1240 from an idle position disposed away from the longitudinal axis of tunneling tube 1220 to an operating position disposed on the longitudinal axis of tunneling tube 1220.

[0103]

[0132] In some embodiments, process 1300 may include step 1312 of moving inserter 1240 from a retracted position to an extended position. In some embodiments, upon moving inserter 1240 from a retracted position to an extended position, device 106 is released from tunneling tube 1220 and device 106 is deployed within subcutaneous pocket 102. In some embodiments, inserter 1240 can be moved from a retracted position to an extended position while inserter 1240 is in an operative position.

[0104]

[0133] In some embodiments, rotating dissection instrument 1230 in step 1306 and / or rotating inserter 1240 in step 1310 may include using hinge 1260 rotatably coupled to dissection instrument 1230 and inserter 1240. In some embodiments, rotating inserter 1240 in step 1310 can be performed after rotating dissection instrument 1230 in step 1306. In some alternative embodiments, rotating dissection instrument 1230 in step 1306 and rotating inserter 1240 in step 1310 may occur simultaneously. In some embodiments, moving dissection instrument 1230 from an extended position to a retracted position and moving inserter 1240 from a retracted position to an extended position may include using slider knob 1251 to move inserter 1240 and dissection instrument 1230.

[0105]

[0134] The subject matter of the present disclosure has been described and illustrated in considerable detail with reference to certain exemplary embodiments including various combinations and sub - combinations of features, but those skilled in the art will readily appreciate other embodiments and their variations and modifications that are encompassed within the scope of the present disclosure. Further, the description of such embodiments, combinations, and sub - combinations is not intended to convey that the claimed subject matter requires features or combinations of features other than those expressly recited in the claims. Accordingly, the scope of the present disclosure is intended to include all modifications and variations that fall within the spirit and scope of the appended claims.

Claims

1. An insertion tool for creating a subcutaneous pocket under the skin surface and implanting a device into the subcutaneous pocket, the insertion tool comprising: a handle defining a cavity within the handle; a tunneling tube defining a passage opening into the cavity of the handle; a dissecting instrument having a blunt tip, configured to (i) create the subcutaneous pocket, move from an extended position where the blunt tip projects from a distal end of the tunneling tube to a retracted position where the blunt tip is disposed within the cavity of the handle, and rotate from an operative position disposed on a longitudinal axis of the tunneling tube to an idle position disposed away from the longitudinal axis of the tunneling tube; a dissecting instrument; an inserter including a cannula, configured to (i) hold the device within a passage of the cannula, rotate from an idle position disposed away from the longitudinal axis of the tunneling tube to an operative position disposed on the longitudinal axis of the tunneling tube, and move from a retracted position to an extended position to release the device from the tunneling tube and dispose the device in the subcutaneous pocket; an inserter; and an insertion tool comprising the same.

2. The insertion tool according to claim 1, wherein the inserter is configured to hold a hydrating fluid within the passage of the cannula.

3. The insertion tool according to claim 1 or 2, wherein the handle includes a hinge rotatably coupled to the dissecting instrument and the inserter.

4. The insertion tool according to any one of claims 1 to 3, wherein when the inserter is set to the operative position, the inserter is configured to move from the retracted position to the extended position.

5. The insertion tool according to any one of claims 1 to 4, wherein the actuator comprises a slider knob configured to move the inserter and the dissecting instrument between the retracted position and the extended position.

6. The insertion tool according to claim 5, further comprising a mechanism for preventing backward movement of the slider knob of the actuator such that after the inserter rotates to the operative position, the cannula of the inserter can only move toward the extended position of the inserter.

7. The insertion tool according to claim 6, wherein the mechanism is a ratchet.

8. The dissecting instrument includes a first rod configured to move along the cavity of the handle and the passage of the tunneling tube, and the blunt tip is coupled to the first rod such that the first rod moves the blunt tip between the retracted position and the extended position along the cavity of the handle and the passage of the tunneling tube. The insertion tool according to any one of claims 1 to 7.

9. The inserter includes a second rod configured to move along the cavity of the handle and the passage of the tunneling tube, and the cannula has a first end configured to hold and release the device and a second end coupled to the second rod. The second end is configured such that the second rod moves the cannula between the retracted position and the extended position along the cavity of the handle and the passage of the tunneling tube. The insertion tool according to any one of claims 1 to 8.

10. An insertion tool according to any one of claims 1 to 9, further comprising a pivot actuator operably connected to the dissecting instrument and the inserter, the insertion tool causing a pivoting movement of the dissecting instrument and the inserter between the idle position and the operating position.

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