Patent Description:
Implantable devices may be implanted within a living animal (e.g., a human). Some implantable devices are implanted in subcutaneous tissue below the skin. Some implantable devices may detect the presence or amount of an analyte (e.g., glucose or oxygen) in a medium (e.g., blood or interstitial fluid) within the living animal.

Known tools for inserting an implantable device in subcutaneous tissue include a tunneling tool and an insertion tool. The tunneling tool may be used to create a tunnel and a subcutaneous pocket below a skin surface, and the insertion tool may be used to deliver the device through the tunnel and into the subcutaneous pocket.

However, when using the insertion tool, the device is typically exposed at the distal end of the insertion tool, such that the device leads the insertion tool through the tunnel below the skin surface. Often, the user has to rotate the insertion tool back and forth to force the device through the tunnel and position the device into the pocket. Such exposure and force may dislocate the device from the insertion tool before the device reaches the subcutaneous pocket and/or damage the device. Moreover, exposing the device at the distal end of the insertion tool while implanting the device may cause trauma to the inside of the pocket, which may result in more bleeding and may cause distortion in the signal transmitted from the device.

<CIT> discloses a device for inserting implantable objects beneath the skin of a patient including a handle and a base that comprises a post, a cannula and a flexible actuator positioned in an angled track. The cannula is slidable over the post from an extended position to a retracted position where the implantable object is released from the cannula. <CIT> discloses an instrument with a two-part plunger for subcutaneous implantation.

Accordingly, there is a need for an improved insertion tool to shield the device from exposure to the skin tissue during insertion and reduced trauma to the subcutaneous pocket while implanting the device. The improved insertion tool may thereby extend the longevity of the device and/or improve accuracy.

The invention relates to an insertion tool as defined in claims <NUM>-<NUM>. Other tools described herein are not meant to be encompassed by the scope of the invention. Aspects of the present invention may relate to an improved insertion tool that shields an implantable device from exposure to the skin tissue during insertion. Embodiments of the improved insertion tool may reduce trauma to the subcutaneous pocket while implanting the device.

The invention provides an insertion tool according to claim <NUM> creating a subcutaneous pocket below a skin surface and implanting a device in the subcutaneous pocket. The insertion tool includes a handle defining a cavity therein. Further, the insertion tool comprises a tunneling tube extending from a first end of the handle and defining a passage opening into the cavity of the handle, and the tunneling tube is configured to move in an axial direction between an extended position and a retracted position. The dissector comprises a blunt tip configured to move between a retracted position, wherein the blunt tip is disposed in the cavity of the handle, and an extended position, wherein the blunt tip protrudes out of a distal end of the tunneling tube, and the dissector is configured to create the subcutaneous pocket. The insertion tool further comprises an insertor comprising a cannula configured to move between a retracted position, wherein the cannula is disposed in the cavity of the handle, and an extended position, wherein the cannula is at least partially disposed in the passage of the tunneling tube. An actuator is disposed in the handle and operatively linked to the the dissector, and the insertor such that the actuator is configured to trigger the blunt tip, and the cannula to move between the retracted and extended positions. The tunneling tube and the cannula are configured such that, when the tunneling tube and the cannula are at the extended position, the cannula holds the device in the passage of the cannula. The tunneling tube and the cannulaare configured such that, when the tunneling tube is at or about the retracted position, the cannula moves toward the retracted position and releases the device out of the tunneling tube to deploy the device in the subcutaneous pocket.

In some embodiments, the dissector may be configured to pivot from an operating position disposed along a first axis defined by the tunneling tube to an idle position disposed along a second axis, and the inserter is configured to pivot from an idle position disposed disposed along a third axis to an operating position disposed along the first axis, wherein the second axis extends at a first acute angle with respect to the first axis, and third axis extends at a second acute angle with respect to the first axis. In some embodiments, the handle may comprise a hinge pivotably coupled to the dissector and the inserter. In some embodiments, the inserter may be configured to pivot between the operating and idle positions when the cannula tube is set in the retracted position, and the cannula tube is configured to move between the retracted and extended positions when the inserter is set at the operating position.

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 cause the the tunneling tube, the blunt tip, and the cannula to move between the retracted and extended positions. In some embodiments, the dissector may comprise 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 is configured to move the blunt tip along the cavity of the handle and the passage of the tunneling tube between the retracted and extended positions. In some embodiments, the insertor may comprise a second rod configured to move along the cavity of the handle and the passage of the tunneling tube, and the cannula comprises a first end configured to hold and release the device and a second end coupled to the second rod such that the second rod is configured to move the cannula along the cavity of the handle and the passage of the tunneling tube between the retracted and extended positions.

The present document also describes a method of using an insertion tool to create a subcutaneous pocket below a skin surface and implant a device in the subcutaneous pocket. The method is not included in the scope of the invention. The method may comprise a step of inserting a cannula of the insertion tool and a dissector tip disposed at a distal end of the cannula into an incision in the skin surface such that the dissector tip and the cannula create the subcutaneous pocket. The method may comprise a step of moving the cannula in an axial direction from an extended position to a retracted position such that a rod disposed along a passage of the cannula forces the device through an opening at the distal end of the cannula, at least partially out of the passage of the cannula, and at least partially into the subcutaneous pocket.

The method may further comprise loading the device into the passage of the cannula. The method may further comprise after loading the device into the passage and before inserting the cannula and the dissector tip, pulling a sleeve around the distal end of the cannula to enclose the opening in the distal end of the cannula. The method may further comprise before the step of loading, pulling a sleeve received around the cannula toward the handle to expose the opening in the distal end of the cannula. The method may further comprise pulling the cannula away from the subcutaneous pocket.

The method may further comprise using an actuator disposed in the handle to move the cannula from the extended position to the retracted position. The method may further comprise pulling a sleeve along the cannula from a closed position, in which the sleeve encloses 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. The method may further comprise a flap covers the opening at the distal end of the cannula, and moving the rod along the passage of the cannula from the retracted position to the extended position spatially separates the flap from the distal end of the cannula and exposes the opening at the distal end of the cannula.

Further variations encompassed within the insertion tools are described in the detailed description of the invention below.

The accompanying drawings, which are incorporated herein and form part of the specification, illustrate various embodiments of the subject matter of this disclosure. In the drawings, like reference numbers indicate identical or functionally similar elements.

In the following, various insertion tools are described but it is understood that only those tools that correspond to the definition in claims <NUM>-<NUM> are within the scope of the invention. Other tools are described for illustrative purposes only.

<FIG> is a schematic view illustrating an insertion tool <NUM>. The insertion tool <NUM> may be for creating a subcutaneous pocket <NUM> below a skin surface <NUM> and implanting a device <NUM> in the subcutaneous pocket <NUM>. The device <NUM> may include an RFID chip. The device <NUM> may include a sensor, such as, for example and without limitation, an analyte sensor (e.g., glucose sensor) and/or a temperature sensor. The insertion tool <NUM> may include one or more of a handle <NUM>, a cannula <NUM>, a dissector tip <NUM>, a rod <NUM>, and an actuator <NUM>.

The cannula <NUM> may extend from the handle <NUM>. The cannula <NUM> may define a passage (e.g., through which the device <NUM> may pass). The cannula <NUM> and dissector tip <NUM> may be configured to create the subcutaneous pocket below <NUM> the skin surface <NUM> by inserting the dissector tip <NUM> and cannula <NUM> into an incision (not shown) made in the skin surface <NUM>. The cannula <NUM> may be configured to move in an axial direction between an extended position and a retracted position. When the cannula <NUM> is set at the extended position, the cannula <NUM> and the dissector tip <NUM> may be configured to create the subcutaneous pocket <NUM> below the skin surface <NUM>. Movement of the cannula <NUM> to the retracted position may deploy the device <NUM> from within the passage of the cannula <NUM> into the subcutaneous pocket <NUM>. When the cannula <NUM> is set at the extended position, a substantial portion of the cannula <NUM> may be disposed outside the handle <NUM>. When the cannula <NUM> is set at the retracted position, a portion or all of the cannula <NUM> may be disposed in a cavity (not shown) of the handle <NUM>.

The rod <NUM> may be disposed (at least partially) in the passage of the cannula <NUM>. movement of the cannula <NUM> between the extended and retracted positions may be relative to the rod <NUM>, which the rod <NUM> may be configured to remain stationary relative to the handle <NUM> in the passage of the cannula <NUM> as the cannula <NUM> moves between the extended and retracted positions. When the cannula <NUM> is set in the extended position, the rod <NUM> may be spatially separated from a distal end of the cannula <NUM> so that the passage of the cannula <NUM> holds the device <NUM>. When the cannula <NUM> is moved from the extended position to the retracted position, the distal end of the cannula <NUM> may move toward the distal end of the rod <NUM>, which may cause the rod <NUM> to act as a backstop and force the device <NUM> within the passage of the cannula <NUM> through an opening at the distal end of the cannula <NUM>, at least partially out of the cannula <NUM>, and at least partially into the subcutaneous pocket <NUM>. While or after retracting the cannula <NUM>, a user may pull the handle <NUM> away from the pocket, leaving the device <NUM> in the subcutaneous pocket <NUM>.

The actuator <NUM> may be disposed in the handle <NUM> and may be operatively connected to the cannula <NUM>. The actuator <NUM> may be configured to move the cannula <NUM> between the retracted and extended positions. The actuator <NUM> may include a track <NUM> extending along the handle <NUM> and a slider knob <NUM> configured to slide along the track <NUM>. Movement of the slider knob <NUM> of the actuator <NUM> may force the cannula <NUM> to move between the extended and retracted positions. The cannula <NUM> may be configured to move from the extended position to the retracted position by sliding the slider knob <NUM> along the track <NUM> in a direction away from the cannula <NUM>. The cannula <NUM> may be configured to move from the retracted position to the extended position by sliding the slider knob <NUM> along the track <NUM> in a direction toward the cannula <NUM>. Further, the actuator <NUM> may additionally or alternatively include other mechanisms, such as, for example, a spring, a solenoid, or a motor, to bring about movement of the cannula <NUM>.

<FIG> illustrate various aspects of the cannula <NUM> and the inserter <NUM> that may be implemented with the insertion tool <NUM> described above.

As shown in <FIG> and <FIG>, the cannula <NUM> may have a tubular shape and may define a passage <NUM> extending along a longitudinal axis of the cannula <NUM>. The cannula <NUM> may comprise a distal end <NUM> defining an opening <NUM> into the passage <NUM>. The distal end <NUM> of the cannula <NUM> may move in an axial direction away from the handle <NUM> when the cannula <NUM> is moving toward the extended position. The distal end <NUM> of the cannula <NUM> may move in an axial direction toward the handle <NUM> when the cannula <NUM> is moving toward the retracted position. The cannula <NUM> may be comprised of, for example and without limitation, stainless steel. Further, the cannula <NUM> may be comprised of a polymeric material, such as, for example and without limitation, PC(polycarbonate), PPSU (polymer polyphenyl sulfone), PEEK (polyether ether ketone), PES (Polyethersulfone) ,POLY (polyarylamide).

As shown in <FIG>, the dissector tip <NUM> may comprise a sleeve <NUM> around at least a portion of the cannula <NUM>. The sleeve <NUM> may comprise one or more perforations <NUM> (e.g., one or more weakened portions or score lines) defining two or more portions <NUM> of the sleeve <NUM> proximate to the distal end <NUM> of the cannula <NUM>. The one or more perforations <NUM> may be separated by pulling the sleeve <NUM> away from the distal end <NUM> of the cannula <NUM> and toward the handle <NUM>. As shown in <FIG>, the separation at the one or more perforations or weakened portions <NUM> may result in the portions <NUM> of the sleeve <NUM> separating from one another. The separated portions <NUM> of the sleeve <NUM> may expose the opening <NUM> into the passage <NUM> of the cannula <NUM>. The sleeve <NUM> may be comprised of a polymeric material, such as, for example and without limitation, PU (polyurethane), PVC(polyvinyl chloride), PTFE (Polytetrafluoroethylene).

The sleeve <NUM> may be operatively connected to the actuator <NUM>. The sleeve <NUM> may be configured to be pulled along the cannula <NUM> from a closed position to an open position by sliding the slider knob <NUM> along the track <NUM> in a direction away from the cannula <NUM>. As shown in <FIG>, when the sleeve <NUM> is in the closed position, the sleeve <NUM> may enclose the opening <NUM> of the distal end <NUM> of the cannula <NUM>. When the sleeve <NUM> is moved to the open position, the sleeve <NUM> may be pulled away from the distal end <NUM> of the cannula <NUM> and toward the handle <NUM>. As shown in <FIG>, moving the sleeve <NUM> toward the open position may separate the one or more perforations or weakened portions <NUM> and expose the opening <NUM> of the distal end <NUM> of the cannula <NUM>. When the sleeve <NUM> is pulled toward the handle <NUM> of the insertion tool <NUM>, the distal end <NUM> of the cannula <NUM> may apply a sufficient amount of force against the sleeve to separate the portions <NUM> of the sleeve <NUM>. The sleeve <NUM> may be configured to be moved toward the open position before the cannula <NUM> moves toward the retracted position to ensure that the distal end <NUM> of the cannula <NUM> engages the portions <NUM> of the sleeve <NUM> with a sufficient amount of force to separate or rupture the perforations or weakened portions <NUM>.

As shown in <FIG>, the distal end <NUM> of the cannula <NUM> may be blunt-shaped. However, the distal end <NUM> of the cannula <NUM> may form other shapes (e.g., a bevel shape) configured to create a tunnel and pocket below the skin surface.

As shown in <FIG>, <FIG>, the rod <NUM> may be disposed, at least partially, in the passage <NUM> of the cannula <NUM>. The rod <NUM> may be configured to remain stationary (relative to the handle <NUM>) in the passage <NUM> of the cannula <NUM> as the cannula <NUM> moves between the retracted position and the extended position. As shown in <FIG>, when the cannula <NUM> is set at the extended position, the rod <NUM> may be spatially separated from the distal end <NUM> of the cannula <NUM> such that the passage <NUM> of the cannula <NUM> receives and/or holds the device <NUM> proximate to the distal end <NUM>. As shown in <FIG>, when the cannula <NUM> is set at the retracted position, the rod <NUM> may be disposed proximate the distal end <NUM> of the cannula <NUM> or may protrude through the distal end <NUM> of the cannula <NUM>. When the cannula <NUM> is moved from the extended position to the retracted position, the rod <NUM> may act as a backstop and force the device <NUM> through the opening <NUM> at the distal end <NUM> of the cannula <NUM> and at least partially out of the cannula <NUM>.

The rod <NUM> may be solid or hollow. The rod <NUM> may be comprised of a rigid material, such as, for example and without limitation, stainless steel, polymeric material, such as ABS, Polycarbonate, Polyarylamide.

The insertion tool <NUM> may create the subcutaneous pocket <NUM> below the skin surface <NUM> by inserting the cannula <NUM> at the extended position with the dissector tip <NUM> through an incision in the skin surface. When the dissector tip <NUM> and the cannula <NUM> are inserted into the incision and while the dissector tip <NUM> and the cannula <NUM> create the subcutaneous pocket <NUM>, the sleeve <NUM> may be set at the closed position (as shown in <FIG>), and the sleeve <NUM> may enclose the device <NUM> in the passage <NUM> of the cannula <NUM>. After creating the subcutaneous pocket <NUM>, the sleeve <NUM> may be moved (e.g., by pulling the sleeve <NUM> toward the handle <NUM>) to the open position in which the opening <NUM> at the distal end <NUM> of the cannula <NUM> is exposed (as shown in <FIG> and <FIG>). After the moving the sleeve <NUM> to the open position, the insertion tool <NUM> may implant the device <NUM> by moving the cannula <NUM> from the extended position toward the retracted position. As the cannula <NUM> moves toward the retracted position, the rod <NUM> may abut against the device <NUM>, act as a backstop, and propel the device <NUM> through the opening <NUM> at the distal end <NUM> of the cannula <NUM>, at least partially out of the cannula <NUM>, and at least partially into the subcutaneous pocket <NUM> (as shown in <FIG>). After moving the cannula <NUM> to the retracted position (or simultaneously therewith), the handle <NUM> may be used to pull the cannula <NUM> out of the subcutaneous pocket <NUM>, and the device <NUM> may be left in the subcutaneous pocket <NUM>.

As shown in <FIG>, the cannula <NUM> may have a bevel-shaped distal end <NUM>. The bevel-shaped distal end <NUM> may define an opening <NUM> into the passage <NUM> of the cannula <NUM>. The dissector tip <NUM> may include a protrusion <NUM> projecting from the distal end <NUM> of the cannula <NUM>. The protrusion <NUM> and the cannula <NUM> may be formed from a single piece of a material.

As shown in <FIG>, the insertion tool <NUM> may further comprise a sleeve <NUM> at least partially around the cannula <NUM>. The sleeve <NUM> may enclose the opening <NUM> at the distal end <NUM> of the cannula <NUM>. The sleeve <NUM> may define an aperture <NUM> proximate to the distal end <NUM> of the cannula <NUM>. The dissector tip <NUM> (e.g., the protrusion <NUM>) may project through the aperture <NUM> of the sleeve <NUM>.

The sleeve <NUM> may comprise a one or more perforations <NUM> (e.g., one or more weakened portions or score lines) defining two or more portions <NUM> of the sleeve <NUM> proximate to the distal end <NUM> of the cannula <NUM>. The one or more perforations <NUM> may be separated by pulling the sleeve <NUM> toward the handle <NUM>. As shown in <FIG>, the separation at the one or more perforations <NUM> may result in the portions <NUM> separating from one another. The separated portions <NUM> of the sleeve <NUM> may expose the opening <NUM> into the passage <NUM> of the cannula <NUM>.

The sleeve <NUM> may be operatively connected to the actuator <NUM>. The sleeve <NUM> may be configured to be pulled along the cannula <NUM> from a closed position to an open position by sliding the slider knob <NUM> along the track <NUM> in a direction away from the cannula <NUM>. As shown in <FIG>, when the sleeve <NUM> is in at the closed position, the sleeve <NUM> may enclose the opening <NUM> of the distal end <NUM> of the cannula <NUM>. As shown in <FIG>, when the sleeve <NUM> is moved to the open position, the sleeve <NUM> may be pulled toward the handle <NUM>. As shown in <FIG>, moving the sleeve <NUM> to the open position may separate the one or more perforations <NUM> and expose the opening <NUM> of the distal end <NUM> of the cannula <NUM>. When the sleeve <NUM> is pulled toward the handle <NUM> of the insertion tool <NUM>, the distal end <NUM> of the cannula <NUM> and the device <NUM> may apply a sufficient amount of force against the aperture <NUM> of the sleeve <NUM> to separate the portions <NUM> of the sleeve <NUM>. The sleeve <NUM> may be configured to be moved toward the open position before the cannula <NUM> moves toward the retracted position to ensure that the distal end <NUM> of the cannula <NUM> engages the portions <NUM> of the sleeve <NUM> with a sufficient amount of force to separate or rupture the perforations or weakened portions <NUM>.

As shown in <FIG>, the rod <NUM> may be disposed, at least partially, in the passage <NUM> of the cannula <NUM>. The rod <NUM> may be configured remain stationary (relative to the handle <NUM>) in the passage <NUM> of the cannula <NUM> as the cannula <NUM> moves between the retracted position and the extended position. As shown in <FIG>, when the cannula <NUM> is set at the extended position, the rod <NUM> may be spatially separated from the distal end <NUM> of the cannula <NUM> such that the passage <NUM> of the cannula <NUM> may receive and/or hold the device <NUM> proximate to the distal end <NUM>. When the cannula <NUM> is set at the retracted position, the rod <NUM> may be disposed proximate the distal end <NUM> of the cannula <NUM> or protruding through the distal end <NUM> of the cannula <NUM>. Moving the cannula from the extended position to the retracted position may force the device <NUM> through the opening <NUM> of the distal end <NUM> of the cannula <NUM>.

The insertion tool <NUM> may create the subcutaneous pocket <NUM> below the skin surface <NUM> by inserting the cannula <NUM> at the extended position with the dissector tip <NUM> through incision in the skin surface. When the dissector tip <NUM> and the cannula <NUM> are inserted into the incision and while the dissector tip <NUM> and the cannula <NUM> create the subcutaneous pocket <NUM>, the sleeve <NUM> may be set at the closed position (as shown in <FIG>) and may enclose the device <NUM> in the passage <NUM> of the cannula <NUM>. After creating the subcutaneous pocket <NUM>, the sleeve <NUM> may be moved (e.g., by pulling the sleeve <NUM> toward the handle <NUM>) to the open position in which the opening <NUM> at the distal end <NUM> of the cannula <NUM> is exposed (as shown in <FIG>). After the moving the sleeve <NUM> to the open position, the insertion tool <NUM> may implant the device <NUM> by moving the cannula <NUM> from the extended position toward the retracted position. As the cannula <NUM> moves toward the retracted position, the rod <NUM> may abut against the device <NUM>, act as a backstop, and propel the device <NUM> through the opening <NUM> at the distal end <NUM> of the cannula <NUM>, at least partially out of the cannula <NUM>, and at least partially into the subcutaneous pocket <NUM>. After moving the cannula <NUM> to the retracted position (or simultaneously therewith), the handle <NUM> may be used to pull the cannula <NUM> out of the subcutaneous pocket <NUM>, and the device <NUM> may be left in the subcutaneous pocket <NUM>.

As shown in <FIG>, the device <NUM> may support the dissector tip <NUM> (e.g., a portion of the surface-area of the device <NUM> may contact the dissector tip <NUM>) when the cannula <NUM> is at the extended position. The device <NUM> may support the dissector tip <NUM> when the dissector tip <NUM> and cannula <NUM> at the extended position are inserted into the incision in the skin surface <NUM> and create the subcutaneous pocket <NUM>. As shown in <FIG>, a front end <NUM> of the device <NUM> may support a sleeve <NUM> when the sleeve <NUM> is in a closed position in which the sleeve <NUM> encloses the opening at the distal end of the cannula <NUM>. As shown in <FIG>, the device <NUM> may have a round edge that approximates the shape of the sleeve <NUM> of the dissector tip <NUM> that covers a blunt-shaped opening at the distal end of the cannula <NUM>. Further, as shown in <FIG>, a front end <NUM> of the device <NUM> may support a sleeve when the sleeve is in a closed position in which the sleeve encloses the opening at the distal end of the cannula <NUM>. As shown in <FIG>, the device <NUM> may have a beveled edge that approximates a bevel-shape of the dissector tip <NUM>.

Referring to <FIG>, The cannula <NUM> may include a bevel-shaped distal end <NUM>. The bevel-shaped distal end <NUM> may define an opening <NUM> into the passage <NUM> of the cannula <NUM>. The cannula <NUM> may be operatively connected to the actuator <NUM>. The cannula <NUM> may be configured to be moved from the extended position to the retracted position by sliding the slider knob <NUM> along the track <NUM> in a direction away from the cannula <NUM>.

The dissector tip <NUM> may include a flap <NUM> coupled to the cannula <NUM>. The flap <NUM> may pivot between a closed position and an open position. When in a closed position, the flap <NUM> may abut against the distal end <NUM> of the cannula <NUM> and enclose the opening <NUM> at the distal end <NUM> of the cannula <NUM>. When in an open position, the flap <NUM> may be spatially separated from the distal end <NUM> and expose the opening <NUM> at the distal end <NUM> of the cannula <NUM>. The flap <NUM> may be configured to pivot from the closed position to the open position upon the application of force, by an object, such as the device <NUM>, moving in an axial direction against the flap <NUM>.

As shown in <FIG>, the flap <NUM> may include an extension <NUM> projecting from an interior surface of the flap <NUM>. When the flap <NUM> is in the closed position, the extension <NUM> may engage the interior surface of the cannula <NUM> to ensure that the flap <NUM> encloses the opening <NUM> of the distal end <NUM>.

As shown in <FIG>, the rod <NUM> may be disposed, at least partially, in the passage <NUM> of the cannula <NUM>. The rod <NUM> may be configured to remain stationary (relative to the handle <NUM>) in the passage <NUM> of the cannula <NUM> as the cannula <NUM> moves between the retracted position and the extended position As shown in <FIG>, when the cannula <NUM> is set at the extended position, the rod <NUM> may be spatially separated from the distal end <NUM> of the cannula <NUM> such that the passage <NUM> of the cannula <NUM> may receive and/or hold the device <NUM> proximate to the distal end <NUM>. When the cannula <NUM> is set at the retracted position, the rod <NUM> may be disposed proximate the distal end <NUM> or protruding through the distal end <NUM> of the cannula <NUM>. When the cannula <NUM> moves from the extended position to the retracted position, the rod <NUM> may force the device <NUM> through the opening <NUM> of the distal end <NUM> of the cannula <NUM>.

The insertion tool <NUM> may create the subcutaneous pocket <NUM> below the skin surface <NUM> by inserting the cannula <NUM> at the extended position with the dissector tip <NUM> through an incision in the skin surface. When the dissector tip <NUM> and the cannula <NUM> are inserted into the incision and while the dissector tip <NUM> and cannula <NUM> create the subcutaneous pocket <NUM>, the flap <NUM> may be in the closed position (as shown in <FIG>). In the closed position, the flap <NUM> may enclose the device <NUM> in the passage <NUM> of the cannula <NUM>. After creating the subcutaneous pocket <NUM>, the insertion tool <NUM> may implant the device <NUM> by moving the cannula <NUM> toward the retracted position. As the cannula <NUM> moves toward the retracted position, the rod <NUM> may abut against the device <NUM> to force the device <NUM> against the flap <NUM>. Forcing the device <NUM> against the flap <NUM> may cause the flap <NUM> to pivot from the closed position to the open position (as shown in <FIG>). The device <NUM> may then be pushed through the opening <NUM> at the distal end <NUM> of the cannula <NUM>, at least partially out of the cannula <NUM>, and at least partially into the subcutaneous pocket <NUM>. After moving the cannula <NUM> to the retracted position (or simultaneously therewith), the handle <NUM> may be used to pull the cannula <NUM> out of the subcutaneous pocket <NUM>, and the device <NUM> may be left in the subcutaneous pocket <NUM>.

As shown in <FIG>, the cannula <NUM> may define a passage <NUM> extending along a longitudinal axis thereof. The cannula <NUM> max be operatively connected to the actuator <NUM>. The cannula <NUM> may be configured to be moved from the extended position to the retracted position by sliding the slider knob <NUM> along the track <NUM> in a direction away from the cannula <NUM>. The cannula <NUM> may include a distal end <NUM> defining an opening <NUM> into the passage <NUM>. When set at the extended position, the cannula <NUM> may be configured to retain and hold at least a portion of the device <NUM> in the passage <NUM> proximate to the open distal end <NUM>. The cannula <NUM> may comprise one or more flexible fingers <NUM> disposed along the cannula <NUM>. The one or more flexible fingers <NUM> may be configured to retain the device <NUM> by flexing toward the longitudinal axis of the cannula <NUM>. The flexible fingers <NUM> may be defined by a pair of parallel slits cut along the cannula <NUM>, and each flexible finger <NUM> may include a strip of the dissector rod <NUM> defined by the pair of slits.

As shown in <FIG>, the dissector tip <NUM> may be integrally connected to the device <NUM>. The dissector tip <NUM> may be a cone-shaped projection <NUM> disposed at a front end of the device <NUM>. When the device <NUM> is partially retained in the passage <NUM> of the cannula <NUM>, the projection <NUM> of the device <NUM> protrudes out of the distal end <NUM> of the dissector rod <NUM>. Projection <NUM> may include one or more shoulders <NUM> projecting from a side of the device <NUM> in a radial direction. When the device <NUM> may be retained in the passage <NUM> of the cannula <NUM>, the distal end <NUM> of the cannula <NUM> may abut against the shoulders <NUM>, thereby ensuring that the projection <NUM> extends away from the distal end <NUM> by a predetermined length.

As shown in <FIG>, the rod <NUM> may be disposed, at least partially, in the passage <NUM> of the cannula <NUM>. The rod <NUM> may be configured to remain stationary (relative to the handle <NUM>) in the passage <NUM> of the cannula <NUM> as the cannula <NUM> moves between the retracted position and the extended position. As shown in <FIG>, when the cannula <NUM> is set at the extended position, the rod <NUM> may be spatially separated from the distal end <NUM> of the cannula <NUM> such that the passage <NUM> of the cannula <NUM> may receive at least a portion of the device <NUM> proximate to the distal end <NUM>. When the cannula <NUM> is set at the retracted position, the rod <NUM> may be disposed proximate the distal end <NUM> or protruding through the distal end <NUM> of the cannula <NUM>. When the cannula <NUM> is moved from the extended position to the retracted position, the rod <NUM> may force the device <NUM> through the opening <NUM> at the distal end <NUM> of the cannula <NUM> and at least partially out of the cannula <NUM>.

As shown in <FIG>, the cannula <NUM> may further comprise one or more ports <NUM> for introducing a hydration fluid (e.g., saline fluid) into the passage <NUM>. The hydration fluid may be introduced into the one or more ports <NUM> as device <NUM> is held in the passage <NUM> of the cannula <NUM>. The hydration fluid may hydrate (or at least begin hydration of) at least a portion of the device <NUM> before implantation of the device <NUM>. For example, for a non-limiting embodiment of a device <NUM> that is an analyte sensor, the analyte sensor may include an analyte indicator including a hydrogel, and the hydration fluid may hydrate (or at least begin hydration of) at least the analyte indicator of the sensor before insertion. The device <NUM> may require hydration before the device <NUM> can operate normally. Accordingly, hydration fluid in the cannula <NUM> may reduce or eliminate an amount of time that the device <NUM> is required to be implanted in the body before device <NUM> operates normally.

The insertion tool <NUM> may create the subcutaneous pocket <NUM> below the skin surface <NUM> by inserting the cannula <NUM> at the extended position with the dissector tip <NUM> through an incision in the skin surface. When the cannula <NUM> is inserted into the incision and while the projection <NUM> and the cannula <NUM> create the subcutaneous pocket <NUM>, the device <NUM> may be partially held in the passage <NUM> of the cannula <NUM> with the projection <NUM> protruding away from the distal end <NUM> of the cannula <NUM>. After creating the subcutaneous pocket <NUM>, the insertion tool <NUM> may implant the device <NUM> by moving the cannula <NUM> toward the retracted position. As the cannula <NUM> moves toward the retracted position, the rod <NUM> may abut against the device <NUM>, act as a backstop, and propel the device <NUM> through the opening <NUM> at the distal end <NUM> of the cannula <NUM>, at least partially out of the cannula <NUM>, and at least partially into the subcutaneous pocket <NUM> (as shown in <FIG>). After moving the cannula <NUM> to the retracted position (or simultaneously therewith), the handle <NUM> may be used to pull the cannula <NUM> out of the subcutaneous pocket <NUM>, and the device <NUM> may be left in the subcutaneous pocket <NUM>.

<FIG> illustrate an exemplary insertion tool <NUM> of the invention for creating the subcutaneous pocket <NUM> below the skin surface <NUM> and implanting the device <NUM> in the subcutaneous pocket <NUM>. The insertion tool <NUM> includes a handle <NUM>, a tunneling tube <NUM>, a dissector <NUM>, an inserter <NUM>, and one or more actuators (not shown). The handle <NUM> defines a cavity <NUM> therein. The tunneling tube <NUM> extends from a first end <NUM> of the handle <NUM> and defines a passage <NUM> opening into the cavity <NUM> of the handle <NUM>.

The tunneling tube <NUM> is configured to move in an axial direction between an extended position and a retracted position. When the tunneling tube <NUM> is set at the extended position, the tunneling tube <NUM> and the dissector <NUM> are configured to create the subcutaneous pocket <NUM> below the skin surface <NUM>. When the tunneling tube <NUM> is moved to the retracted position, the tunneling tube <NUM> and the inserter <NUM> are configured to deploy the device <NUM> into the subcutaneous pocket <NUM>. In some embodiments, when the tunneling tube <NUM> is set at the extended position, a substantial portion of the tunneling tube <NUM> may be disposed outside the handle <NUM>. In some embodiments, when the tunneling tube <NUM> is set at the retracted position, a portion or all of the tunneling tube <NUM> may be disposed in a cavity <NUM> of the handle <NUM>.

In some embodiments, the dissector <NUM> may comprise a first rod <NUM> disposed at least partially in the cavity <NUM> of the handle <NUM>. In some embodiments, the first rod <NUM> may be rigid. However, this is not required, and, in some alternative embodiments, the first rod <NUM> may be flexible. In some embodiments, the first rod <NUM> may comprise of a polymeric material, such as nylon, polypropylene, or polyvinylchloride. In some embodiments, a dissector tip <NUM> may be coupled to a distal end of the first rod <NUM>. In some embodiments, the dissector tip <NUM> and the first rod <NUM> may be configured to move between an extended position and a retracted position. <FIG> show the dissector tip <NUM> and the first rod <NUM> in the extended and retracted positions, respectively. In some non-limiting embodiments, as shown in <FIG>, when at the extended position, the dissector tip <NUM> may protrude out of a distal end of the tunneling tube <NUM>. In some embodiments, the dissector tip <NUM> may be configured to create the subcutaneous pocket <NUM> below the skin surface <NUM>. In some embodiments, as shown in <FIG>, when set at the retracted position, the dissector tip <NUM> may be disposed in the cavity <NUM> of the handle <NUM>.

In some embodiments, the first rod <NUM> may be operatively connected to an actuator, and the actuator may be configured to move the first rod <NUM> and the dissector tip <NUM> between the extended and retracted positions. In some embodiments, the actuator may be configured to move the dissector tip <NUM> out of the tunneling tube <NUM> and into the cavity <NUM>. In some embodiments, the actuator may be a slider or a lever connected to the first rod <NUM>. In some embodiments, the actuator may be a spring loaded mechanism connected to the first rod <NUM> to advance and retract the first rod <NUM>. Although some embodiments include an actuator configured to move the first rod <NUM> and the dissector tip <NUM> between extended and retracted positions, this actuator is not required, and, in some alternative embodiments, a user may move the first rod <NUM> and the dissector tip <NUM> from the extended position shown in <FIG> to the retracted position shown in <FIG> by pulling directly on the first rod <NUM>.

In some embodiments, the inserter <NUM> may comprise a second rod <NUM> disposed at least partially in the cavity <NUM> of the handle <NUM>. In some embodiments, the second rod <NUM> may be rigid. However, this is not required, and, in some alternative embodiments, the second rod <NUM> may be flexible. In some embodiments, the inserter <NUM> may include a cannula <NUM>. In some embodiments, the cannula <NUM> may include a first end 842A configured to hold and release the device <NUM>. In some embodiments, the cannula <NUM> may include a second end 842B coupled to a distal end of the second rod <NUM>. In some embodiments, the second rod <NUM> may be configured to move along the cavity <NUM> of the handle <NUM>. In some embodiments, the cannula <NUM> may be configured to move between a retracted position and an extended position. In some embodiments, the cannula <NUM> may be configured to slide along the second rod <NUM> toward the retracted position, as the tunneling tube <NUM> moves toward the retracted position.

<FIG> show the cannula <NUM> in the retracted and extended positions, respectively. In some embodiments, as shown in <FIG>, when at the retracted position, the cannula <NUM> may be disposed in the cavity <NUM> of the handle <NUM>. In some embodiments, as shown in <FIG>, when at the extended position, the cannula <NUM> may be at least partially disposed in the passage <NUM> of the tunneling tube <NUM>. In some embodiments, the tunneling tube <NUM> may hold the cannula <NUM> in place at its extended position. In some embodiments, when the cannula <NUM> is at its extended position and at least partially disposed in the tunneling tube <NUM>, the tunneling tube <NUM> may retract in axial direction toward the handle <NUM>, which may also slide the cannula <NUM> back toward the handle <NUM>. In some embodiments, as the cannula <NUM> retracts with the tunneling tube <NUM> into the cavity <NUM> of the handle <NUM>, the second rod <NUM> may remain in an extended position and abut against the device <NUM> to force the device <NUM> at least partially out of the cannula <NUM> and the tunneling tube <NUM> and at least partially into the subcutaneous pocket <NUM>.

In some embodiments, the second rod <NUM> may be operatively connected to an actuator, and the actuator may be configured to move the second rod <NUM>, the cannula <NUM>, and the tunneling tube <NUM> between retracted and extended positions. In some embodiments, the actuator configured to move the second rod <NUM>, the cannula <NUM>, and the tunneling tube <NUM> between retracted and extended positions may be the same actuator that is configured to move the first rod <NUM> and the dissector tip <NUM> between retracted and extended positions. In some embodiments, the actuator may be a slider knob (not shown) configured to slide along a track (not shown) disposed along the handle <NUM>. In some embodiments, the actuator may include a fork (not shown) extending from the slider knob and comprising a plurality of prongs connected to the first rod <NUM> and the second rod <NUM>. In some embodiments, the actuator may include a catch mechanism (not shown), such as a strut, to hold the second rod <NUM> in the extended position, while the actuator moves the tunneling tube <NUM> and the cannula <NUM> toward the retracted position. In some alternative embodiments, a first actuator may be configured to move the second rod <NUM> and the cannula <NUM> between retracted and extended positions, and a different, second actuator may be configured to move the first rod <NUM> and the dissector tip <NUM> between retracted and extended positions.

In some embodiments, the insertion tool <NUM> may create the subcutaneous pocket <NUM> below the skin surface <NUM> by setting the dissector <NUM> in the extended position (as shown in <FIG>) and inserting the tunneling tube <NUM> with the dissector tip <NUM> protruding from the tunneling tube <NUM> through an incision in the skin surface. In some embodiments, after creating the subcutaneous pocket <NUM>, the dissector tip <NUM> and first rod <NUM> may be moved from their extended position to their retracted position. In some embodiments, the second rod <NUM> and cannula <NUM> may then be moved from the retracted position toward the extended position so that the cannula <NUM> (with the device <NUM> held therein) is disposed at least partially in the tunneling tube <NUM>. In some embodiments, with the cannula <NUM> disposed at least partially in the tunneling tube <NUM>, the tunneling tube <NUM> may be retracted toward the handle <NUM> to slide the cannula <NUM> along the second rod <NUM> and at least partially into the cavity <NUM> of the handle <NUM>. In some embodiments, as the cannula <NUM> retracts with the tunneling tube <NUM> into the cavity <NUM> of the handle <NUM>, the second rod <NUM> may remain in the extended position (e.g., using the catch mechanism of the actuator <NUM>) and abut against the device <NUM> to force the device <NUM> at least partially out of the cannula <NUM> and the tunneling tube <NUM>. In some embodiments, the handle <NUM> may be used to pull the tunneling tube <NUM> out of the subcutaneous pocket <NUM>, and the device <NUM> may be left in the subcutaneous pocket <NUM>. In some embodiments, one or more of the dissector tip <NUM>, first rod <NUM>, cannula <NUM>, and second rod <NUM> may be moved while keeping the tunnel tube <NUM> disposed in the subcutaneous pocket <NUM>.

<FIG> and <FIG> illustrate an exemplary insertion tool <NUM> for creating the subcutaneous pocket <NUM> below the skin surface <NUM> and implanting the device <NUM> in the subcutaneous pocket <NUM>. The insertion tool <NUM> comprises a handle <NUM>, a tunneling tube <NUM>, a dissector <NUM>, an inserter <NUM>, and an actuator <NUM>.

In some embodiments, the insertion tool <NUM> may include one or more of the same features as the embodiment of the insertion tool <NUM> shown in <FIG>. The tunneling tube <NUM> is configured to move between an extended position to create the subcutaneous pocket <NUM> using the dissector <NUM> and a retracted position to deploy the device <NUM> into the subcutaneous pocket <NUM> using the inserter <NUM>. In some embodiments, the dissector <NUM> may include a first rod <NUM> configured to move along a cavity <NUM> of the handle <NUM> and a dissector tip <NUM> coupled to a distal end of the first rod <NUM>. In some embodiments, the inserter <NUM> may include a second rod <NUM> configured to move along the cavity <NUM> of the handle <NUM> and a cannula <NUM> configured to hold the device <NUM> at a first end 942A and coupled to the second rod <NUM> at a second end 942B.

In some embodiments, as shown in <FIG> and <FIG>, the dissector <NUM> may be configured to pivot from an operating position disposed along a first axis A defined by the tunneling tube <NUM> to an idle position disposed along a second axis B. In some embodiments, the second axis B may extend at an acute angle θAB (e.g., <NUM>°) with respect to the first axis A. In some embodiments, the inserter <NUM> 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 θAC (e.g., <NUM>°) with respect to the first axis A.

In some embodiments, as shown in <FIG> and <FIG>, the insertion tool <NUM> may further comprise a hinge <NUM>. In some non-limiting embodiments, the hinge <NUM> may be disposed in the handle <NUM>. In some embodiments, the hinge <NUM> may include a first arm <NUM> disposed in the cavity <NUM> and configured to pivot about an axis defined by the hinge <NUM> from the operating position extending along the first axis A to the idle position extending along the second axis B. In some embodiments, the hinge <NUM> may include a second arm <NUM> disposed in the cavity <NUM> and configured to pivot about an axis defined by the hinge <NUM> from the idle position extending along the third axis C to the operating position extending along the first axis A.

In some embodiments, the first arm <NUM> may define a passage, and the dissector tip <NUM> and the first rod <NUM> may be disposed in the passage of the first arm <NUM>. In some embodiments, the dissector <NUM> may be configured to move between the operating and idle positions as the first arm <NUM> pivots about the hinge <NUM>. In some embodiments, the dissector tip <NUM> and the first rod <NUM> may be configured to move along the passage of the first arm <NUM> between retracted and extended positions when the first arm <NUM> is set at the operating position extending along the first axis A. In some embodiments, the dissector tip <NUM> and the first rod <NUM> may be configured to remain stationary in the retracted position when the first arm <NUM> is set at the idle position extending along the second axis B.

In some embodiments, the second arm <NUM> may define a passage, and the cannula <NUM> and the second rod <NUM> may be disposed in the passage of the second arm <NUM> such that the inserter <NUM> may be configured to move between the idle and operating positions as the second arm <NUM> pivots about the hinge <NUM>. In some embodiments, the cannula tube <NUM> and the second rod <NUM> may be configured to move along the passage of the second arm <NUM> is set at the operating position extending along the first axis A. In some embodiments, the cannula tube <NUM> and the second rod <NUM> may be configured to remain stationary in the retracted position when the second arm <NUM> is set at the idle position extending along the third axis C.

In some embodiments, the insertion tool <NUM> may include a pivot actuator <NUM> operatively connected to the dissector <NUM> and the inserter <NUM> to cause the pivoting movement of the dissector <NUM> and the inserter <NUM> between the idle and operating positions. In some embodiments, the pivot actuator <NUM> may include, for example and without limitation, a twist knob or a slider. In other embodiments (not shown), the insertion tool <NUM> may comprise other internal mechanisms (e.g. a spring-loaded device) to move the dissector <NUM> and the inserter <NUM> between the idle and operating positions.

In some embodiments, the actuator <NUM> may be disposed in the handle <NUM> and may be operatively connected to the tunneling tube <NUM>, the dissector <NUM>, and the inserter <NUM>. In some embodiments, the actuator <NUM> may be configured to selectively force the tunneling tube <NUM>, the dissector <NUM>, and the inserter <NUM> to move between retracted and extended positions. In some embodiments, the actuator <NUM> may include a track (not shown) extending along the handle <NUM> and a slider knob <NUM> configured to slide along the track. In some embodiments, the actuator <NUM> may include a fork (not shown) extending from the slider knob <NUM> and configured to removably connect to the dissector <NUM> and inserter <NUM> when pivoted into the operating position. In some embodiments, the actuator <NUM> may include a catch mechanism (not shown), such as a strut, to hold the second rod <NUM> in the extended position, while the actuator <NUM> moves the tunneling tube <NUM> and the cannula <NUM> toward the retracted position.

In some embodiments, the insertion tool <NUM> may create the subcutaneous pocket <NUM> below the skin surface <NUM> by first setting the dissector <NUM> in the operating position (e.g., using the pivot actuator <NUM>) and sliding the dissector tip <NUM> and the first rod <NUM> to the extended position (as shown in <FIG>) (e.g., using the actuator <NUM>). In some embodiments, the subcutaneous pocket <NUM> may be created by inserting the tunneling tube <NUM> with the dissector tip <NUM> protruding from the tunneling tube <NUM> through an incision in the skin surface. In some embodiments, after creating the subcutaneous pocket <NUM>, the dissector tip <NUM> and first rod <NUM> may be moved from their extended position to their retracted position. In some embodiments, the dissector <NUM> in the retracted position may be pivoted from the operating position along the first axis A to the idle position along the second axis B, and the inserter <NUM> may be pivoted from the idle position along the third axis C to the operating position along the first axis A (e.g., using pivot actuator <NUM>). In some embodiments, the second rod <NUM> and cannula <NUM> of the inserter <NUM> in the operating position may then be moved from the retracted position toward the extended position (e.g., using the actuator <NUM>) so that the cannula <NUM> (with the device <NUM> held therein) is disposed at least partially in the tunneling tube <NUM>. In some embodiments, with the cannula <NUM> disposed at least partially in the tunneling tube <NUM>, the tunneling tube <NUM> may be retracted toward the handle <NUM> (e.g., using the actuator <NUM>) to slide the cannula <NUM> along the second rod <NUM> and into at least partially into the cavity <NUM> of the handle <NUM>. In some embodiments, as the cannula <NUM> retracts with the tunneling tube <NUM> into the cavity <NUM> of the handle <NUM>, the second rod <NUM> may remain in the extended position (e.g., using the catch mechanism of the actuator <NUM>), abuts against the device <NUM>, act as a backstop, and force the device <NUM> at least partially out of the cannula <NUM> and the tunneling tube <NUM>. In some embodiments, after at least partially retracting the tunneling tube <NUM> into the cavity <NUM> of the handle <NUM> (or simultaneously therewith), the handle <NUM> may be used to pull the tunneling tube <NUM> out of the subcutaneous pocket <NUM>, and the device <NUM> may be left in the subcutaneous pocket <NUM>. In some embodiments, one or more of the dissector tip <NUM>, first rod <NUM>, cannula <NUM>, second rod <NUM>, actuator <NUM>, and pivot actuator <NUM> may be moved while keeping the tunneling tube <NUM> disposed in the subcutaneous pocket <NUM>.

<FIG> illustrates an insertion tool <NUM>, which may comprise any of the features described in <FIG>. The insertion tool <NUM> may include one or more guide prongs <NUM> extending from a first end of the handle <NUM>. The one or more guide prongs <NUM> may be configured to limit the depth at which the dissector rod <NUM> is capable of creating the subcutaneous pocket <NUM>. The dissector rod <NUM> may extend farther from the end of the handle <NUM> than the one or more guide prongs <NUM>.

All the configurations of the insertion tools <NUM>, <NUM>, <NUM>, and <NUM> described herein may include a loading port disposed in the handle and in communication with the cannula for introducing a hydration fluid (e.g., saline fluid) into the cannula. The hydration fluid may hydrate (or at least begin hydration of) at least a portion of the device <NUM> (e.g., an analyte indicator or hydrogel of the device <NUM>) before implantation of the device <NUM>.

<FIG> is a flow chart showing a method <NUM> of creating a subcutaneous pocket below a skin surface and implanting a device in the subcutaneous pocket. The insertion tools <NUM>, <NUM>, <NUM>, and <NUM> described above in <FIG> may be used to create the subcutaneous pocket and implant the device according to the method described in <FIG>. The method is not within the scope of the invention.

The method <NUM> may include a step <NUM> of loading the device into a passage of a cannula extending from a handle of the insertion tool.

The method <NUM> may include a step <NUM> of inserting a cannula of the insertion tool and a dissector tip disposed at a distal end of the cannula into an incision in the skin surface such that the dissector tip and the cannula create the subcutaneous pocket.

The method <NUM> may include a step <NUM> of moving the cannula from an extended position to a retracted position such that a rod disposed along the passage of the cannula forces the device through an opening at the distal end of the cannula, out of the passage of the cannula, and into the subcutaneous pocket.

The method <NUM> may further include, after loading the device into the passage and before inserting the cannula and the dissector tip, a step of pulling a sleeve around the distal end of the cannula to enclose the opening in the distal end of the cannula. The method <NUM> may further include, before the step of loading, a step of pulling a sleeve received around the cannula toward the handle to expose the opening in the distal end of the cannula.

The method <NUM> may further include using an actuator disposed in the handle to move the cannula from the extended position to the retracted position. In some embodiments the method <NUM> may further include pulling the cannula away from the subcutaneous pocket.

The method <NUM> may further include a step of pulling a sleeve along the cannula from a closed position, in which the sleeve encloses 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.

Claim 1:
An insertion tool (<NUM>, <NUM>) for creating a subcutaneous pocket (<NUM>) below a skin surface (<NUM>) and implanting a device (<NUM>) in the subcutaneous pocket, the insertion tool comprising:
a handle (<NUM>, <NUM>) defining a cavity (<NUM>, <NUM>) therein;
wherein the insertion tool further comprises:
a tunneling tube (<NUM>, <NUM>) extending from a first end of the handle and defining a passage opening into the cavity of the handle, and the tunneling tube is configured to move in an axial direction between an extended position and a retracted position;
a dissector (<NUM>, <NUM>) comprising a blunt tip (<NUM>, <NUM>) configured to move between a retracted position, wherein the blunt tip is disposed in the cavity of the handle, and an extended position, wherein the blunt tip protrudes out of a distal end of the tunneling tube, and the dissector is configured to create the subcutaneous pocket;
an insertor (<NUM>, <NUM>) comprising a cannula (<NUM>, <NUM>) configured to move between a retracted position, wherein the cannula is disposed in the cavity of the handle, and an extended position, wherein the cannula is at least partially disposed in the passage of the tunneling tube; and
an actuator (<NUM>) disposed in the handle and operatively linked to the dissector, and the insertor such that the actuator is configured to trigger the blunt tip, and the cannula to move between the retracted and extended positions;
wherein the tunneling tube and the cannula are configured such that, when the tunneling tube and the cannula are at the extended position, the cannula holds the device in the passage of the cannula, and, when the tunneling tube is at or about the retracted position, the cannula moves toward the retracted position and releases the device out of the tunneling tube to deploy the device in the subcutaneous pocket.