Patent Description:
Certain diseases or conditions may be treated, according to modern medical techniques, by delivering a medication fluid or other substance to the body of a patient, either in a continuous manner or at particular times or time intervals within an overall time period. For example, diabetes is often treated by delivering defined amounts of insulin to the patient at appropriate times. Some modern systems employ programmable fluid infusion devices (e.g., insulin pumps) to deliver controlled amounts of insulin to a patient via a cannula. Moreover, in certain instances, it may also be desirable for the patient to receive information from a physiological characteristic monitor, such as a glucose monitor. In these instances, the physiological characteristic monitor and the cannula are often separately coupled to the user's anatomy at different insertion sites so that insulin delivered via the cannula does not interfere with measurements by the physiological characteristic monitor. <CIT> s related to an implantable vascular access port, comprising a plug casing having plugs, a port frame and a means for affixing the plug casing to the port frame. <CIT> is related to a dual insertion set for supplying a fluid to a body of a patient and for monitoring a body characteristic of the patient, wherein the dual insertion set comprises a base, an infusion portion and a sensor portion. <CIT> is related to an extended use infusion set for a medical patient.

The disclosure generally relates to a first insertion needle and a second insertion needle configured to respectively carry a first medical device and a second medical device through an opening in an apparatus housing. The second insertion needle may be configured to carry the second medical device along a curved path that passes through the opening such that a distal end of the first medical device becomes increasingly displaced from a distal end of the second medical device as the distal end of the second medical device is carried along the curved path.

Although different figures use the same numerals, the figures should not be construed as depicting the same elements. For example, element <NUM> of <FIG> is not necessarily the same as element <NUM> of <FIG>.

The disclosure describes an insertion device configured to at least partially implant a first medical device (e.g., a sensor) and a second medical device (e.g., a cannula) within a patient via the same insertion site on the patient. At least the second medical device may be inserted into the patient along a curved path that passes through the insertion site and into the patient. Inserting the second medical device along the curved path enables the distal end of the second medical device to become increasingly separated from the distal end of the first medical device. Among other benefits, the techniques implemented by the insertion device enable reduction or avoidance of interference between the medical devices while decreasing patient discomfort.

The insertion device may facilitate use of a therapy delivery device (e.g., a fluid infusion device) configured to provide a therapeutic fluid to a user (e.g., a patient) and monitor a physiological characteristic of the user. For example, the first medical device may be a fluid delivery cannula configured to deliver a fluid (e.g., insulin) to the user. The second medical device may be an analyte sensor (e.g., a glucose sensor) configured to detect a physiological characteristic of the user (e.g., a glucose level). The insertion device may be configured to insert the first medical device and the second medical device in the user substantially concurrently. In examples, the therapy delivery device is a portable system configured to be worn by the user.

The therapy delivery device may include a housing configured to be positioned proximate to the skin of the user. In examples, the housing is configured to contact the skin of the user. The housing may be configured to be substantially secured to a location on the user in order to, for example, allow mobility to the user as the therapy delivery device administers and monitors therapies delivered to the user. For example, the therapy delivery device may be configured to allow a degree of user mobility as the therapy delivery device delivers insulin to the user through a fluid delivery cannula (e.g., the first medical device) and monitors a glucose level of the user using an analyte sensor (e.g., the second medical device). The therapy delivery device may be substantially secured to the user using any suitable arrangement. In some examples, the housing of the therapy delivery device includes an adhesive element configured to removably secure the housing to the skin of the user.

In examples, the therapy delivery device is configured such that, when positioned on the skin of the user, the user may initiate at least partial implantation of the first medical device and the second medical device. For example, the user may initiate the at least partial implantation using a manually operated button on the housing, a wireless communication to the therapy delivery device, or some other user-controlled activation.

The insertion device may be internal/external to the therapy delivery device. Stated differently, in some embodiments, the insertion device may be included within the housing of the therapy delivery device, and in some other embodiments, the insertion device may be included within a second housing that can engage and disengage the housing of the therapy delivery device as desired. The insertion device may be configured to cause a first insertion needle and a second insertion needle to extend through an opening in the therapy delivery device housing to at least partially implant the first and second medical devices in a patient. The insertion device may also be configured to subsequently withdraw the insertion needles from the patient such that the first and second medical devices remain at least partially implanted within the patient.

The first and second insertion needles may be configured to insert through and withdraw from the skin of the patient. The first insertion needle and/or second insertion needle may be configured to pierce the skin of the patient. Upon activation by the user, the insertion device may cause the first insertion needle and the second insertion needle to extend from the therapy delivery device housing to insert through the skin and/or to subsequently retract toward the therapy delivery device housing to withdraw from the skin. In some embodiments, the first insertion needle may be integrated with the first medical device such that both the needle and the medical device remain inserted in the patient. In some other embodiments, the first insertion needle may be configured to releasably carry the first medical device, such that the first insertion needle at least partially implants the first medical device during its extension and leaves the first medical device at least partially implanted within the patient during its retraction. In some embodiments, the second insertion needle may be integrated with the second medical device such that both the needle and the medical device remain inserted in the patient. In some other embodiments, the second insertion needle may be configured to releasably carry the second medical device, such that the second insertion needle at least partially implants the second medical device during its extension and leaves the second medical device at least partially implanted during its retraction. In examples, the insertion device is configured to cause the first and second insertion needles to cause at least partial implantation of the first medical device and second medical device substantially concurrently.

The insertion device may be configured to cause the first insertion needle and the second insertion needle to insert through the skin of the patient at a single insertion site on the patient. The insertion site may be a relatively small area on the skin of the patient. Using the same insertion site may reduce the number of punctures distributed over the skin. The insertion device may be configured such that the first insertion needle and the second insertion needle are inserted substantially concurrently in order to, for example, limit discomfort to the patient that might otherwise be caused by multiple insertions at different times.

Although the first insertion needle and the second insertion needle are inserted at the same insertion site on the patient, the distal end of the first medical device may become displaced from the distal end of the second medical device within the patient. In examples, the insertion device is configured to cause the first insertion needle to extend in a first direction away from the therapy delivery device housing and cause the second insertion needle to extend in a different, second direction away from the therapy delivery device housing. The displacement may reduce negative effects that may occur due to proximity between the first medical device and the second medical device. For example, displacement between the distal ends of a fluid delivery cannula and an analyte sensor may help prevent readings reported by the analyte sensor (e.g., glucose levels) from being adversely impacted by delivery of a fluid (e.g., insulin) through the fluid delivery cannula.

The therapy delivery device may include a variety of internal components configured to use the first medical device and the second medical device to provide therapy and monitor a physiological characteristic of the user. In examples, the first medical device and/or the second medical device is a fluid delivery cannula, and the therapy delivery device includes a fluid pump (e.g., an insulin pump) configured to deliver a fluid (e.g., insulin) to the user from a fluid reservoir within the therapy delivery device. The fluid reservoir may be, for example, a volume defined by a detachable fluid cartridge configured to mechanically engage a housing of the therapy delivery device and to establish a fluidic connection with the fluid pump. In examples, the therapy delivery device includes processing circuitry configured to control an operation of the fluid pump. For example, the processing circuitry may be configured to cause the fluid pump to commence, continue, and/or cease causing transportation of fluid from the fluid reservoir through the fluid delivery cannula. In examples, the first medical device and/or the second medical device is an analyte sensor configured to generate a signal indicative of a physiological characteristic of the user (e.g., a glucose level), and the processing circuitry is configured to determine the physiological characteristic using the indicative signal. In some examples, the processing circuitry is configured to control an operation of the fluid pump based on the indicative signal reported by the analyte sensor.

The insertion device may include one or more axles, and each axle may be configured to rotate around a respective longitudinal axis of rotation. Each axle may be configured to rotate in a first rotational direction and a second rotational direction around the axis of rotation, with the second rotational direction being opposite the first rotational direction. For example, an axle may be configured to cause the first insertion needle and the second insertion needle to extend away from the therapy delivery device housing to insert through the skin when the axle rotates in the first rotational direction. The axle may also be configured to cause the first insertion needle and the second insertion needle to retract toward the therapy delivery device housing when the axle rotates in the second rotational direction. In examples, a first axle may be configured to rotate around a first axis of rotation to cause the insertion and/or retraction of the first insertion needle, and a second axle may be configured to rotate around a second axis of rotation parallel to the first axis to cause the insertion and/or retraction of the second insertion needle. The first axle may be configured to rotate a first circular gear, and the second axle may be configured to rotate a second circular gear. The circular gears may be meshed such that the axles rotate in opposite directions.

The one or more axles may be configured to substantially drive the first insertion needle and the second insertion needle to insert through the skin. In examples, the first insertion needle and/or the second insertion needle defines a curved path when the one or more axles drive the first insertion needle and the second insertion needle. For example, the first insertion needle may be a curved needle substantially curving around an axle's axis of rotation. The first insertion needle may be configured such that, as the first insertion needle is driven through the skin, a distal end of the first insertion needle ("first needle distal end") substantially tunnels through subcutaneous tissue of the patient in a curved path (e.g., a circular path) relative to the axle's axis of rotation. In examples, the first insertion needle is configured such that the curved path of the first needle distal end causes the first needle distal end to be displaced from a distal end of the second insertion needle ("second needle distal end"). For example, the first insertion needle may be a curved needle having a first degree of curvature, and the second insertion needle may be a curved needle having a second degree of curvature that is opposite in direction but equal in magnitude to the first degree of curvature. Thus, the first and second insertion needles may puncture the skin at the same site but symmetrically diverge as they are further inserted below the skin.

In examples, one of the first insertion needle or the second insertion needle defines a path having a reduced curvature (e.g., a substantially straight path) compared to the other of the first insertion needle or the second insertion needle. For example, the second insertion needle may be a substantially straight needle configured to exhibit a linear motion relative to the therapy delivery device housing when an axle drives the first insertion needle and the second insertion needle. The second insertion needle may be configured such that, as the axle drives the second insertion needle through the skin, the second needle distal end substantially tunnels through subcutaneous tissue of the user in a straight path relative to the therapy delivery device housing. Hence, as the rotation of the axle causes insertion of the first insertion needle and the second insertion needle, the substantially curved path defined by one insertion needle (e.g., first insertion needle) and the reduced curvature (e.g., substantially straight) path defined by the other insertion needle (e.g., the second insertion needle) causes the first needle distal end and the second needle distal end to diverge (e.g., displace) during the insertion. The divergence may cause displacement between the distal end of the first medical device and the distal end of the second medical device to increase as the first medical device and the second medical device are further inserted into the user.

An axle can be configured to impart a torque to a curved needle (e.g., the first insertion needle) in a variety of ways In examples, the axle is operatively connected to the curved needle using, for example, a strut attached to the axle and attached to the curved needle. In some examples, the axle is directly attached to the curved needle. In some examples, a surface of the axle is configured to frictionally engage a surface of the curved needle to impart the torque to the curved needle. In some examples, the axle may be configured to rotate a pinion gear meshed with a curved rack gear coupled to the curved needle. Thus, when the axle rotates around its axis of rotation, the curved needle may also rotate around the axis of rotation. The axle may be configured to impart a torque to the curved needle in a first rotational direction and/or a second rotational direction. In examples, the axle is configured to impart a torque to the curved needle in the first rotational direction to cause the curved needle to insert through the skin of the patient, and configured to impart a torque to the curved needle in the second rotational direction to cause the curved needle to withdraw from the skin of the patient.

The axle may be configured to cause a substantially straight needle (e.g., the second insertion needle) to move substantially linearly with respect to the therapy delivery device housing. The axle and the substantially straight needle may be cooperatively configured to convert a rotation of the axle to a linear movement of the substantially straight needle with respect to the therapy delivery device housing. In examples, the axle is configured to rotate a pinion gear meshed with a substantially straight rack gear coupled to the substantially straight needle, such that rotation of the pinion gear causes a linear movement of the substantially straight needle. In examples, a surface of the axle is configured to frictionally engage a surface of the substantially straight needle to cause the linear movement of the substantially straight needle.

The insertion device may include a torsion spring configured to cause an axle to rotate. For example, the insertion device may include one or more loaded torsion springs configured to become unloaded when the user activates the insertion device. In examples, the insertion device includes a first torsion spring configured to cause the axle to rotate in a first rotational direction and a second torsion spring configured to cause the axle to rotate in a second rotational direction. The insertion device may be configured such that the first torsion spring causes rotation of the axle in the first rotational direction (e.g., to insert the first insertion needle and the second insertion needle) and such that the second torsion spring subsequently causes rotation in the axle in the second rotational direction (e.g., the retract the first insertion needle and the second insertion needle).

In examples, the insertion device is configured such that a certain amount of rotation in the first rotational direction causes the second torsion spring to become loaded to subsequently cause the rotation in the second rotational direction. For example, the insertion device may be configured such that rotation in the first rotational direction applies load to the second torsion spring. Then, the second torsion spring may become unloaded to cause rotation of the axle in the second rotational direction. In some examples, the insertion device is configured to cause one or more mechanical stops engaging the second torsion spring to disengage after the certain amount of rotation in the first rotational direction such that the second torsion spring may become unloaded to cause the rotation of the axle in the second rotational direction.

Hence, the therapy delivery device may be positioned proximate to the skin of a user, and the insertion device may cause a first insertion needle and a second insertion needle to extend away from the therapy delivery device housing, to be inserted through the skin, and/or to retract toward the therapy delivery device housing for withdrawal from the skin. The first insertion needle may be configured to at least partially implant a first medical device in the user and the second insertion needle may be configured to at least partially implant a second medical device in the user. The insertion device may be operatively connected to a user input device configured to allow the user to control when the insertion device causes at least partial implantation of the first medical device and the second medical device. In examples, the first medical device is a fluid delivery cannula and the second medical device is an analyte sensor. The therapy delivery device may include a fluid pump (e.g., an insulin pump) configured to deliver a fluid (e.g., insulin) to the user, and may include processing circuitry configured to receive signals indicative of a physiological characteristic of the user (e.g., a glucose level) from the analyte sensor. The processing circuitry may be configured to control an operation of the fluid pump based on the indicative signals received from the analyte sensor. The therapy delivery device may be utilized to administer a variety of medications to a user such as, but not limited to, disease treatments, drugs to treat pulmonary hypertension, iron chelation drugs, pain medications, anti-cancer treatments, medications, vitamins, hormones, or the like.

<FIG> is a top perspective view of an example therapy delivery device <NUM> configured as a fluid infusion device. The fluid infusion device may be implemented as a patch pump device. <FIG> is a bottom perspective view of therapy delivery device <NUM>. <FIG> is a schematic side view of an example therapy delivery device <NUM> contacting a body <NUM> of a user. <FIG>, and <FIG> depict some possible configurations and form factors of a therapy delivery device <NUM>. Other designs and configurations can be utilized if so desired, and the particular design aspects shown and/or described in <FIG>, <FIG>, and elsewhere are not intended to limit or otherwise restrict the scope or application of the examples described herein.

Therapy delivery device <NUM> includes a device housing <NUM> that may serve as a shell for a variety of internal components of therapy delivery device <NUM>. For example, device housing <NUM> may mechanically support one or more internal components configured to monitor a physiological characteristic of a user and/or delivery therapy to the user. In examples, device housing <NUM> is configured to mechanically support one or more insertion needles configured to insert one or more medical devices into the user. Device housing <NUM> may mechanically support one or more components configured to cause the one or more insertion needles to insert the medical devices in the user. In some examples, device housing <NUM> is configured to mechanically support internal components configured to utilize and/or communicate with the medical devices for monitoring of and/or delivering therapy to the user. For example, device housing <NUM> may mechanically support a first insertion needle configured to insert a fluid delivery cannula into the user, a second insertion needle configured to insert an analyte sensor into the user, a fluid pump configured to cause delivery of a fluid from a fluid reservoir and through the fluid delivery cannula, and processing circuitry configured to communicate with the analyte sensor and/or the fluid pump. Device housing <NUM> may be configured to position therapy delivery device <NUM> proximate and/or in contact with the skin of the user.

In examples, device housing <NUM> may be configured to mechanically support a removable fluid cartridge <NUM> defining a fluid reservoir. Fluid cartridge <NUM> may be, for example, a disposable insulin cartridge. Device housing <NUM> may be suitably configured to receive, secure, and release fluid cartridge <NUM>. For example, <FIG> depict a fluid cartridge <NUM> installed and substantially secured within device housing <NUM>. Device housing <NUM> may be configured such that, when fluid cartridge <NUM> is mechanically supported by (e.g., installed in) device housing <NUM>, a fluid pump mechanically supported by device housing <NUM> establishes a fluidic connection with the fluid reservoir defined by fluid cartridge <NUM>. Device housing <NUM> may include a suitably shaped, sized, and configured cavity configured to engage particular physical characteristics of fluid cartridge <NUM>. For example, the device housing <NUM> can include structural features that mate with or otherwise engage structural features of fluid cartridge <NUM>.

Fluid cartridge <NUM> may have any shape, size, and/or configuration sufficient to engage with device housing <NUM>. In examples, fluid cartridge <NUM> includes a cartridge retention mechanism <NUM> configured to secure fluid cartridge <NUM> in an installed and seated position within therapy delivery device <NUM>. Retention mechanism <NUM> may mechanically engage device housing <NUM> to substantially lock the fluid cartridge <NUM> in place to maintain physical and/or fluidic connections between the fluid cartridge <NUM> and one or more components of therapy delivery device <NUM>. Retention mechanism <NUM> may be configured to allow physical manipulation by the user to remove and/or install fluid cartridge <NUM>.

In some embodiments, therapy delivery device <NUM> includes at least one user input device <NUM> which may be actuated by the user as needed. User input device <NUM> may be a manually operated button on device housing <NUM>; circuitry configured to receive a communication (e.g., a wireless communication) from a smart phone, tablet, or other external device; and/or some other device configured for receiving user input. In examples, user input device <NUM> (e.g., a button) is configured to cause an insertion device to insert a first medical device and/or second medical device into the user. In some embodiments, the user input device <NUM> may provide a multipurpose user interface configured to initiate multiple operations of therapy delivery device <NUM>. For example, user input device <NUM> may be configured to cause one or more of the following functions, without limitation: waking up the processor and/or electronics of therapy delivery device <NUM>; triggering an insertion device to insert a first medical device (e.g., a fluid delivery cannula) and/or a second medical device (e.g., an analyte sensor) into a subcutaneous space or similar region of the user; configuring one or more settings of therapy delivery device <NUM>; initiating delivery of medication fluid; initiating a fluid priming operation; disabling alerts or alarms generated by therapy delivery device <NUM>; and the like. In lieu of a button, user input device <NUM> can employ a slider mechanism, a pin, a lever, a switch, a touch-sensitive element, or the like.

User input device <NUM> may be configured to receive a communication from a device remote from device housing <NUM> (e.g., a wireless communication) to initiate performance of one or more of the above-described functions, or other functions. In examples, therapy delivery device <NUM> includes more than one user input device <NUM> (e.g., more than one button) to initiate the various functions described above.

In examples, therapy delivery device <NUM> is a portable device. Therapy delivery device <NUM> may be a wearable device configured to be worn by the user. As depicted in <FIG>, therapy delivery device <NUM> may include an adhesive element <NUM> or an adhesive material configured to substantially affix the device housing <NUM> to the body of the user. Adhesive element <NUM> may be configured to substantially secure therapy delivery device <NUM> to the skin <NUM> (<FIG>) of the user. Adhesive element <NUM> may be located on a bottom surface of the device housing <NUM> such that the device housing <NUM> can be temporarily adhered to the skin of the user. The adhesive element <NUM> may cover substantially all of the lower surface (as depicted), or it can only partially cover the lower surface if so desired. Adhesive element <NUM> may be, for example, a piece of double-sided adhesive tape that is cut into the desired shape and size. In some examples, therapy delivery device <NUM> is manufactured with an adhesive liner overlying adhesive element <NUM>, and the adhesive liner is peeled away to expose the sticky surface of adhesive element <NUM>.

Device housing <NUM> may include a base surface <NUM> (which is covered by the adhesive element <NUM> in <FIG>). Base surface <NUM> may be configured to serve as the user-mounting structure of therapy delivery device <NUM>. In examples, base surface <NUM> includes at least one hole <NUM> forming an opening through device housing <NUM>. Hole <NUM> may further form an opening through adhesive element <NUM> when adhesive element <NUM> covers some portion of base surface <NUM>.

Hole <NUM> may be defined to accommodate passage of one or more insertion needles and medical devices from a position within device housing <NUM> to a position at least partially outside of device housing <NUM>. In examples, hole <NUM> is configured (e.g., shaped, sized, and/or located) to accommodate passage of a first insertion needle and a first medical device (e.g., a fluid delivery cannula), and accommodate passage of a second insertion needle and a second medical device (e.g., an analyte sensor). Hole <NUM> may be configured to accommodate passage of the needles and medical devices from a position within device housing <NUM> to a position at least partially outside of device housing <NUM>. Hole <NUM> may be configured to accommodate retraction of the first insertion needle and the second insertion needle from a position outside device housing <NUM> to a position within device housing <NUM>. In examples, hole <NUM> is configured to accommodate substantially concurrent passage of the first insertion needle, the first medical device, the second insertion needle, and the second medical device. Thus, when device housing <NUM> is positioned proximate to the user, hole <NUM> may specify an insertion site on the user, and the insertion site may be shared by the first and second medical devices in that they are each inserted via the insertion site.

<FIG> depicts a therapy delivery device <NUM> in schematic form. Therapy delivery device <NUM> is depicted proximate to (e.g., in contact with) the skin <NUM> of a user. A first medical device <NUM> is inserted in the user and extends through hole <NUM> from a position within device housing <NUM> to a position outside of device housing <NUM> (e.g., a first location under the skin <NUM>). A second medical device <NUM> is inserted in the user and extends through hole <NUM> from another position within device housing <NUM> to another position outside of housing <NUM> (e.g., a second location under the skin <NUM>). In examples, first medical device <NUM> is a fluid delivery cannula configured to deliver a fluid (e.g., insulin) to the first location and second medical device <NUM> is an analyte sensor configured to sense a physiological characteristic (e.g., a glucose level) at the second location. Insertion device <NUM> is configured to insert first medical device <NUM> and second medical device <NUM> into the user such that the first location and the second location are separated by a displacement D. <FIG> further depicts adhesive element <NUM> configured to substantially secure the device housing <NUM> to the skin of the user.

Insertion device <NUM> may be configured to cause insertion of first medical device <NUM> and second medical device <NUM> within the user when, for example, the user actuates insertion device <NUM> using user input device <NUM>. Thus, in some embodiments, user input device <NUM> may be a component of the insertion device <NUM>. For example, user input device <NUM> may be a manually operated button on housing <NUM> of insertion device <NUM>. Insertion device <NUM> may be configured to cause a first insertion needle (e.g., first insertion needle <NUM> (<FIG>, <FIG>)) to extend through hole <NUM> to insert first medical device <NUM> (e.g., a fluid delivery cannula) into the user, and/or configured to cause the first insertion needle to retract back through hole <NUM> while first medical device <NUM> remains inserted in the user. Insertion device <NUM> may be configured to cause a second insertion needle (e.g., second insertion needle <NUM> (<FIG>, <FIG>)) to extend through hole <NUM> to insert second medical device <NUM> (e.g., an analyte sensor) into the user, and/or configured to cause the second insertion needle to retract back through hole <NUM> while second medical device <NUM> remains inserted in the user. In some embodiments, insertion device <NUM> may be a component of therapy delivery device <NUM>. In some other embodiments, insertion device <NUM> may be separate from therapy delivery device <NUM>. For example, insertion device <NUM> may include a housing <NUM> configured to couple with device housing <NUM> during insertion and to detach from device housing <NUM> when insertion is complete.

Therapy delivery device <NUM> may also comprise a fluid infusion system <NUM> and a sensor system <NUM>. Fluid infusion system <NUM> may be configured to deliver a fluid (e.g., insulin) to the user. Sensor system <NUM> may be configured to monitor a physiological characteristic of the user (e.g., a glucose level).

<FIG> is an example simplified block diagram representation of a therapy delivery device <NUM> including device housing <NUM>, user input device <NUM>, first medical device <NUM>, second medical device <NUM>, insertion device <NUM> including a first insertion needle <NUM> and a second insertion needle <NUM>, fluid infusion system <NUM> including a fluid pump <NUM> and a pump motor <NUM>, and sensor system <NUM> including a sensor interface <NUM>. First insertion needle <NUM> may be configured to releasably engage first medical device <NUM>. Second insertion needle <NUM> may be configured to releasably engage second medical device <NUM>. Insertion device <NUM> is configured to cause first insertion needle <NUM> to move (e.g., generally along the path S1) to engage first medical device <NUM> and cause insertion of first medical device <NUM> in the user. Insertion device <NUM> is configured to cause second insertion needle <NUM> to move (e.g., generally along the path S2) to cause insertion of second medical device <NUM> in the user. Insertion device <NUM> may be configured to retract first insertion needle <NUM> and second insertion needle <NUM> to a position within housing <NUM> while first medical device <NUM> and second medical device <NUM> remain inserted in the user.

Therapy delivery device <NUM> may be configured to provide a fluid (e.g., insulin) to a user using, for example, first medical device <NUM>. Therapy delivery device <NUM> may be configured to provide the fluid when first medical device <NUM> is inserted within the user (<FIG>). Therapy delivery device <NUM> may be configured to monitor a physiological characteristic (e.g., a glucose level) of the user using, for example, second medical device <NUM>. Therapy delivery device <NUM> may be configured to monitor the physiological characteristic when second medical device <NUM> is inserted within the user (<FIG>). Insertion device <NUM> is configured to cause first insertion needle <NUM> and second insertion needle <NUM> to extend away from device housing <NUM> to insert first medical device <NUM> and second medical device <NUM> respectively into the user, and may be configured to cause first insertion needle <NUM> and second insertion needle <NUM> to retract toward housing <NUM> as first medical device <NUM> and second medical device <NUM> remain inserted. In examples, first insertion needle <NUM> is configured to insert first medical device <NUM> and second insertion needle <NUM> is configured to insert second medical device <NUM> via hole <NUM>.

Insertion device <NUM> may be implemented in a variety of ways. In the example of <FIG>, insertion device <NUM> includes an axle <NUM> configured to rotate around a longitudinal axis of rotation L ("axis L"). However, it should be appreciated that in some embodiments, an insertion device can be implemented without an axle, and in some other embodiments, an insertion device can be implemented with multiples axles.

In <FIG>, axis L is depicted perpendicular to the page, although this is not required. Axis L may have any orientation with respect to housing <NUM> and/or other components of therapy delivery device <NUM>. Insertion device <NUM> may comprise axle <NUM> configured to rotate in a first rotational direction R1 around axis L and in a second rotational direction R2 opposite the first rotational direction R1 to cause first insertion needle <NUM> and second insertion needle <NUM> to insert first medical device <NUM> and second medical device <NUM> respectively.

Insertion device <NUM> is configured to cause first insertion needle <NUM> and second insertion needle <NUM> to extend through hole <NUM> and toward the user when axle <NUM> rotates in the first rotational direction R1 and may be configured to cause first insertion needle <NUM> and second insertion needle <NUM> to retract through hole <NUM> and away from the user when axle <NUM> rotates in the second rotational direction R2. In examples, first insertion needle <NUM> includes a distal end <NUM> ("first needle distal end <NUM>") and second insertion needle <NUM> includes a distal end <NUM> ("second needle distal end <NUM>").

In some embodiments, insertion device <NUM> may be a component of therapy delivery device <NUM>. Thus, insertion device <NUM> may be configured to cause first needle distal end <NUM> and second needle distal end <NUM> to move from positions within housing <NUM> to positions outside housing <NUM> when axle <NUM> rotates in the first rotational direction R1, and may be configured to cause first needle distal end <NUM> and second needle distal end <NUM> to move from positions outside housing <NUM> to positions inside housing <NUM> when axle <NUM> rotates in the second rotational direction R2. First insertion needle <NUM> and second insertion needle <NUM> may be configured to insert first medical device <NUM> and second medical device <NUM> respectively within a user when first insertion needle <NUM> and second insertion needle <NUM> extend outside of housing <NUM>, and/or configured to release first medical device <NUM> and second medical device <NUM> respectively when first insertion needle <NUM> and second insertion needle <NUM> retract inside of housing <NUM>, such that first medical device <NUM> (e.g., a fluid delivery cannula) and second medical device <NUM> (e.g., an analyte sensor) remain inserted in the user. In examples, first insertion needle <NUM> and second insertion needle insert first medical device <NUM> and second medical device <NUM> substantially concurrently.

In some other embodiments, insertion device <NUM> may be external to therapy delivery device <NUM>. As will be described in greater detail below, insertion device <NUM> may comprise housing <NUM> configured to couple with housing <NUM> for insertion of medical devices <NUM> and <NUM> into the patient.

Insertion device <NUM> may be configured to cause first needle distal end <NUM> to travel substantially along the first path S1 when insertion device <NUM> extends and/or retracts first insertion needle <NUM>. Insertion device <NUM> may be configured to cause second needle distal end <NUM> to travel substantially along the second path S2 when insertion device <NUM> extends and/or retracts second insertion needle <NUM>. In examples, insertion device <NUM> is configured such that the first path S1 and the second path S2 cause first needle distal end <NUM> and second needle distal end <NUM> to increasingly displace from each other as first needle distal end <NUM> and/or second needle distal end <NUM> move in a direction away from housing <NUM>. In examples, insertion mechanism unit <NUM> is configured such that one of first path S1 or second path S2 defines a first curvature around axis L and the other of first path S1 or second path S2 defines a second curvature around axis L. In some embodiments, the second curvature may be less than the first curvature. For example, insertion device <NUM> may be configured such that first path S1 is substantially circular and second path S2 is substantially linear. In some embodiments, the first curvature and the second curvature may have opposite orientations. For example, the first curvature may be clockwise whereas the second curvature may be counterclockwise. Insertion device <NUM> may define the first path S1 and the second path S2 in order to generate the displacement D (<FIG>) between first medical device <NUM> and second medical device <NUM> within body <NUM> of the user.

Insertion device <NUM> may be configured to cause first needle distal end <NUM> and second needle distal end <NUM> to pass through hole <NUM> as first needle distal end <NUM> and second needle distal end <NUM> transition to the positions in the patient. In examples, insertion device <NUM> is configured to cause first needle distal end <NUM> and second needle distal end <NUM> to pass through an insertion area <NUM> on the skin <NUM> (<FIG>) of the patient. Insertion area <NUM> may be a relatively small area on the skin of the patient, such that the patient only perceives a single piercing action from the penetration of both first insertion needle <NUM> and second insertion needle <NUM>. In some examples, insertion device <NUM> is configured to cause first insertion needle <NUM> and second insertion needle <NUM> to insert through the skin of the patient through substantially the same puncture site on the skin of the patient. For example, one of first insertion needle <NUM> or second insertion needle <NUM> may be configured to initially pierce and insert through the skin at the puncture site, and the other of first insertion needle <NUM> or second insertion needle <NUM> may be configured to subsequently insert through the skin through substantially the same puncture site.

Insertion device <NUM> further includes a driver <NUM> configured to cause the rotation of axle <NUM> in the first rotational direction R1 and/or the second rotational direction R2. In examples, driver <NUM> is configured to cause axle <NUM> to initially rotate in the first rotational direction R1 and subsequently in the second rotational direction R2 (e.g., to cause initial extension of insertion needles <NUM>, <NUM> followed by subsequent retraction of insertion needles <NUM>, <NUM>). For example, driver <NUM> may be configured to initially cause first needle distal end <NUM> and/or second needle distal end <NUM> to move from a position within housing <NUM> to a position outside of housing <NUM> (e.g., by initially rotating axle <NUM> in the first rotational direction R1), and configured to subsequently cause first needle distal end <NUM> and/or second needle distal end <NUM> to move from a position outside housing <NUM> to a position within housing <NUM> (e.g., by subsequently rotating axle <NUM> in the second rotational direction R2). In examples, user input device <NUM> is configured to cause driver <NUM> to rotate axle <NUM> in the first rotational direction R1 and/or the second rotational direction R2, such that the user may control the implantation of first medical device <NUM> and second medical device <NUM>. In some examples, as will be discussed, driver <NUM> may include one or more springs configured to cause axle <NUM> to rotate around axis L. In some examples, driver <NUM> includes a first spring configured to rotate axle <NUM> in the first rotational direction R1 and a second spring configured to rotate axle <NUM> in the second rotational direction R2. In some examples, each spring is a torsion spring configured to release from a loaded configuration to an unloaded configuration and/or vice versa to cause axle <NUM> to rotate around axis L.

In examples, therapy delivery device <NUM> comprises a first conduit <NUM> that defines a first flow path <NUM> from a discharge <NUM> of fluid pump <NUM> to first medical device <NUM>. In examples, first medical device <NUM> is a fluid delivery cannula defining an interior lumen <NUM>, and first conduit <NUM> is configured to define first flow path <NUM> from a discharge <NUM> of fluid pump <NUM> through lumen <NUM> of the fluid delivery cannula. Therapy delivery device <NUM> may be configured to accommodate a fluid reservoir <NUM> (e.g., within device housing <NUM> and/or fluid cartridge <NUM> (<FIG>)). In examples, therapy delivery device <NUM> includes a second conduit <NUM> configured to define second flow path <NUM> from reservoir <NUM> to a suction <NUM> of fluid pump <NUM>. Fluid pump <NUM> may include motor <NUM> configured to cause fluid pump <NUM> to create pressure to deliver fluid (e.g., via first flow path <NUM>). Fluid infusion system <NUM> may include one or more of fluid pump <NUM>, motor <NUM>, first conduit <NUM>, fluid reservoir <NUM>, and/or second conduit <NUM>.

Therapy delivery device <NUM> may include one or more of a processor device <NUM>; one or more of a memory element <NUM> to store and/or maintain data, processor-readable program instructions; one or more of a battery <NUM> or other power source; and/or a sensor interface <NUM> configured to establish electrical connectivity with a medical device, such as second medical device <NUM>. Processor device <NUM>, memory element <NUM>, battery <NUM>, and/or sensor interface <NUM> may be included on an electronics assembly <NUM> (e.g., a printed circuit board). In examples, second medical device <NUM> is an analyte sensor configured to be electrically connected to sensor interface <NUM> (e.g., via conductive wires) to establish electrical connectivity between conductors of the analyte sensor and conductors of the electronics assembly <NUM>. Electronics assembly <NUM> (or the components of electronics assembly <NUM>) can be electrically connected to other elements of therapy delivery device <NUM> as needed to support the operation of therapy delivery device <NUM>. For example, the electronics assembly <NUM> can be electrically connected to at least the following, without limitation: the fluid pump <NUM>; the sensor interface <NUM>; the insertion device <NUM>; and the user input device <NUM>. It should be appreciated that electrical connections to the electronics assembly <NUM> can be direct or indirect if so desired. Moreover, one or more components of the electronics assembly <NUM> may support wireless data communication in some embodiments.

In examples, processor device <NUM> includes processing circuitry configured to control an operation of fluid pump <NUM>. For example, the processing circuitry may be configured to cause the fluid pump <NUM> to commence, continue, and/or cease causing transportation of fluid from fluid reservoir <NUM> to first medical device <NUM> (e.g., a fluid delivery cannula).

In examples, first medical device <NUM> and/or second medical device <NUM> is an analyte sensor configured to generate a signal indicative of a physiological characteristic of the user (e.g., a glucose level), and the processing circuitry is configured to determine the physiological characteristic using the indicative signal. In some examples, the processing circuitry is configured to control an operation of fluid pump <NUM> based on the indicative signal reported by the analyte sensor. The analyte sensor may be coupled to sensor system <NUM>. Sensor system <NUM> may also include sensor interface <NUM> and conductive wires for connecting the analyte sensor to sensor interface <NUM>.

Device housing <NUM> may be suitably shaped, sized, and configured to house or support the electronics assembly <NUM>, the fluid pump <NUM>, the fluid reservoir <NUM>, the sensor interface <NUM>, and/or the user input device <NUM>. The fluid infusion system <NUM> depicted in <FIG> may include at least the fluid pump <NUM>, the fluid reservoir <NUM>, first conduit <NUM>, and second conduit <NUM> shown in <FIG>. The sensor system <NUM> depicted in <FIG> may include at least the sensor interface <NUM> shown in <FIG>.

<FIG> schematically illustrate interaction between a portion of therapy delivery device <NUM> and insertion device <NUM>. Insertion device <NUM> may include axle <NUM> configured to cause first insertion needle <NUM> to extend and/or retract through hole <NUM> in housing <NUM> and configured to cause second insertion needle <NUM> to extend and/or retract through hole <NUM> in housing <NUM>. Axis L is included for reference. Driver <NUM> may be configured to rotate axle <NUM> in the first rotational direction R1 to cause insertion device <NUM> to transition from the configuration of <FIG> to the configuration of <FIG>, in order to cause insertion needles <NUM>, <NUM> to extend through hole <NUM> in housing <NUM>. Driver <NUM> may be configured to rotate axle <NUM> in the second rotational direction R2 to cause insertion device <NUM> to transition from the configuration of <FIG> to the configuration of <FIG>, in order to cause insertion needles <NUM>, <NUM> to retract through hole <NUM> in housing <NUM>. First insertion needle <NUM> and second insertion needle <NUM> may be configured to release first medical device <NUM> and second medical device <NUM> respectively, such that first medical device <NUM> and second medical device <NUM> remain inserted in the user when insertion needles <NUM>, <NUM> are retracted by insertion device <NUM>. In examples, driver <NUM> includes a first spring <NUM> configured to cause axle <NUM> to rotate in the first rotational direction R1 and a second spring <NUM> configured to cause axle <NUM> to rotate in the second rotational direction R2.

Axle <NUM> may be configured to drive first insertion needle <NUM> to cause first needle distal end <NUM> to insert through the skin of the user when axle <NUM> rotates in the first rotational direction R1 around axis L. First insertion needle <NUM> may be configured such that movement of first needle distal end <NUM> defines a curved path S1 around axis L when axle <NUM> drives first insertion needle <NUM> to insert through the skin of the user. In examples, first insertion needle <NUM> is a curved needle substantially curving around axis L. First insertion needle <NUM> may be configured such that, as axle <NUM> drives first insertion needle <NUM> through the skin, first needle distal end <NUM> substantially tunnels through tissue of the user in a curved path (e.g., the path S1) relative to axis L. In examples, when axle <NUM> rotates in the first rotational direction R1 around axis L, insertion device <NUM> causes first insertion needle <NUM> to rotate in the first rotational direction R1 around axis L. In examples, insertion device <NUM> is configured to cause first insertion needle <NUM> to engage first medical device <NUM> when axle <NUM> rotates in the first rotational direction R1. For example, first insertion needle <NUM> may become progressively narrower toward distal end <NUM> such that rotation of axle <NUM> causes needle <NUM> to be inserted through lumen <NUM> until first medical device <NUM> makes contact with needle <NUM>. As will be discussed, first insertion needle <NUM> may be configured to engage first medical device <NUM> to displace at least some portion of first medical device <NUM> from a position within housing <NUM> (e.g., a position within first conduit <NUM> as depicted in <FIG>) to a position outside of housing <NUM> (e.g., as depicted in <FIG>).

Axle <NUM> may be configured to impart a torque around axis L to an insertion needle (e.g., first insertion needle <NUM> and/or second insertion needle <NUM>) curving around the axis L. For example, in <FIG>, axle <NUM> is configured to impart a torque around axis L to first insertion needle <NUM> curving around the axis L. Axle <NUM> may impart the torque such that first insertion needle <NUM> substantially rotates around axis L when the axle <NUM> rotates around axis L. In examples, axle <NUM> is mechanically connected to first insertion needle <NUM> to impart the torque. For example, axle <NUM> may be mechanically connected to first insertion needle by a strut <NUM> extending between axle <NUM> and first insertion needle <NUM>, however this is not required. Axle <NUM> may impart the torque around axis L to first insertion needle <NUM> in any manner. In some examples, a surface of axle <NUM> is configured to frictionally engage a surface of first insertion needle <NUM>, such that the frictional engagement causes axle <NUM> to impart the torque to first insertion needle <NUM>. In some examples, axle <NUM> may be configured to rotate a pinion gear meshed with a curved rack gear coupled to first insertion needle <NUM>, such that the meshing causes axle <NUM> to impart the torque to first insertion needle <NUM>.

Axle <NUM> may be further configured to drive second insertion needle <NUM> to cause second needle distal end <NUM> to insert through the skin of the user when axle <NUM> rotates in the first rotational direction R1 around axis L. In examples, second insertion needle <NUM> is a substantially straight needle configured to exhibit a linear motion relative to housing <NUM> when axle <NUM> rotates around axis L. Second insertion needle <NUM> may be configured such that movement of second needle distal end <NUM> defines a path S2 when axle <NUM> drives second insertion needle <NUM> to insert through the skin of the user. In examples, the path S2 has a different curvature (e.g., a reduced curvature) relative to axis L compared to the path S1. In some examples, the path S2 is a substantially linear path. Second insertion needle <NUM> may be configured such that, as axle <NUM> drives second insertion needle <NUM> through the skin, second needle distal end <NUM> substantially tunnels through tissue of the user substantially along the path S2. Second insertion needle <NUM> may be configured to engage second medical device <NUM> to displace at least some portion of second medical device <NUM> from a position within housing <NUM> (e.g., as depicted in <FIG>) to a position outside of housing <NUM> (e.g., as depicted in <FIG>). For example, second insertion needle <NUM> may have a hollow portion toward distal end <NUM>, and an opening may be defined in distal end <NUM> such that rotation of axle <NUM> causes needle <NUM> to accommodate second medical device <NUM> within the hollow portion.

In examples, axle <NUM> is configured to impart a substantially linear force to an insertion needle (e.g., first insertion needle <NUM> and/or second insertion needle <NUM>). For example, in <FIG>, axle <NUM> is configured to impart the substantially linear force to second insertion needle <NUM> to cause second needle distal end <NUM> to travel along the path S2. Axle <NUM> may impart the substantially linear force when axle <NUM> rotates around axis L. In examples, axle <NUM> is operatively connected to second insertion needle <NUM> to impart the substantially linear force. In some examples, axle <NUM> is configured to cause the rotation of a pinion gear (e.g., pinion gear <NUM> (<FIG>)) meshed with a rack gear (e.g., rack gear <NUM> (<FIG>)) coupled to second insertion needle <NUM>, however this is not required. Axle <NUM> may impart the substantially linear force to second insertion needle <NUM> in any manner, including any manner of mechanism configured to convert a rotational torque of axle <NUM> to a substantially linear force on second insertion needle <NUM>. In some examples, a surface of axle <NUM> is configured to frictionally engage a surface of second insertion needle <NUM>, such that the frictional engagement causes axle <NUM> to impart the substantially linear force to second insertion needle <NUM>.

<FIG> schematically illustrates an example of an insertion device <NUM> including a driver <NUM>. In the example of <FIG>, driver <NUM> includes first spring <NUM> configured to cause axle <NUM> to rotate relative to housing <NUM> in the first rotational direction R1. First spring <NUM> may be configured to convert potential energy into kinetic energy to cause the rotation. For example, first spring <NUM> may be in a charged (e.g., wound or loaded) condition storing potential energy, and may convert some portion of the potential energy to kinetic energy (e.g., by fully or partially unwinding or unloading) to cause axle <NUM> to rotate in the first rotational direction R1. Insertion device <NUM> may be configured such that the full or partial unwinding or unloading of first spring <NUM> transitions insertion device <NUM> from the configuration of <FIG> to the configuration of <FIG>. In examples, first spring <NUM> is a torsion spring configured to rotate around axis L in the first rotational direction R1 when first spring <NUM> converts potential energy to kinetic energy. First spring <NUM> may be mechanically engaged with axle <NUM>, such that rotation of first spring <NUM> around axis L in the first rotational direction R1 causes rotation of axle <NUM> in the first rotational direction R1. In examples, first spring <NUM> includes a helical coil <NUM> ("first helical coil <NUM>") surrounding axis L and configured to rotate around axis L. In examples, first helical coil <NUM> surrounds axle <NUM>. Axle <NUM> may be mechanically engaged with first spring <NUM> (e.g., first helical coil <NUM>) such that, when first spring <NUM> rotates around axis L, spring <NUM> imparts a first torque around axis L to axle <NUM>.

In examples, first spring <NUM> is a torsion spring having a primary end <NUM> ("first spring primary end <NUM>") and a secondary end <NUM> ("first spring secondary end <NUM>"). The torsion spring may be configured to store potential energy by substantially winding (e.g., twisting around) a spring axis, and may be configured to cause movement of first spring primary end <NUM> relative to first spring secondary end <NUM> as the torsion spring unwinds to expend the potential energy. The spring axis may be substantially parallel to and/or coincident with axis L. First spring <NUM> may be configured to exert the first torque on axle <NUM> when first spring primary end <NUM> moves relative to first spring secondary end <NUM>. In examples, first spring <NUM> is configured to cause first spring primary end <NUM> to move relative to first spring secondary end <NUM> in the rotational direction R3 around axis L when first spring <NUM> expends potential energy. The rotational direction R3 may be similar or substantially the same as first rotational direction R1. In some examples, first spring secondary end <NUM> is coupled to a support structure <NUM> configured to be substantially stationary with respect to housing <NUM> such that motion of first spring primary end <NUM> relative to support structure <NUM> causes the relative motion between first spring primary end <NUM> and first spring secondary end <NUM>.

In examples, insertion device <NUM> includes a release mechanism unit configured to substantially maintain a position of first spring primary end <NUM> relative to first spring secondary end <NUM> such that first spring <NUM> is constrained from exerting a torque on axle <NUM> until user input device <NUM> (<FIG>, <FIG>, <FIG>) is actuated. When user input device <NUM> is actuated, insertion device <NUM> may be configured to allow first spring primary end <NUM> to move relative to first spring secondary end <NUM>, such that first spring <NUM> (e.g., first helical coil <NUM>) imparts a torque to axle <NUM> causing axle <NUM> to rotate around axis L in the first rotational direction R1. For example, insertion device <NUM> may include a mechanical stop <NUM> configured to mechanically engage first spring <NUM> (e.g., first spring primary end <NUM>) to constrain movement of first spring primary end <NUM> relative to first spring secondary end <NUM>, such that first spring <NUM> is substantially preventing from exerting a torque on axle <NUM>. Mechanical stop <NUM> may be configured to mechanically disengage from spring <NUM> (e.g., first spring primary end <NUM>), such that spring <NUM> is free to cause first spring primary end <NUM> to move in the rotational direction R3 relative to first spring secondary end <NUM>, and such that first spring <NUM> exerts a torque in the first rotational direction R1 on axle <NUM>.

In some examples, instead of or in addition to mechanical stop <NUM>, insertion device <NUM> may include a mechanical stop <NUM> configured to substantially prevent the rotation of axle <NUM> in the first rotational direction R1, such that axle <NUM> resists a torque imparted by first spring <NUM>. Mechanical stop <NUM> may be configured to mechanically disengage from axle <NUM>, such the torque imparted by spring <NUM> causes rotation of axle <NUM>. In examples, mechanical stop <NUM> and/or <NUM> is configured to establish a first position wherein spring <NUM> is constrained from causing a rotation of axle <NUM>, and configured to establish a second position wherein spring <NUM> is not constrained from causing a rotation of axle <NUM>. User input device <NUM> may be configured to cause mechanical stop <NUM> and/or <NUM> to transition from the first position to the second position. User input device <NUM> may be coupled with mechanical stop <NUM>, <NUM> wirelessly, electrically, mechanically or in any other effective way.

Driver <NUM> including first spring <NUM> and/or second spring <NUM> is one example of a driver configured to cause rotation of axle <NUM>. Driver <NUM> may cause the rotation of axle <NUM> in any manner. In examples, driver <NUM> includes one or more motors configured to cause the rotation of axle <NUM>. The one or more motors may be, for example, a rotary motor configured to cause the rotation using a rotation of an output shaft, a linear motor configured to cause the rotation using translation of a slider, or other type of motors configured to produce an output motion (e.g., relative to a motor housing) and use the output motion to cause the rotation. The one or more motors may be constant or variable speed motors, and may be configured to cause the rotation of axle <NUM> at a constant rotational speed or a varying rotational speed. In examples, the one or more motors are be configured to receive power from a battery (e.g., battery <NUM> within therapy delivery device <NUM>). Insertion device <NUM> and/or therapy delivery device <NUM> may include processing circuitry configured to control the one or motors (e.g., configured to cause a motor to generate motion, to cease generating motion, to generate motion at a particular speed, etc.) In examples, user input device <NUM> is configured to actuate the one or more motors to cause the rotation of axle <NUM>.

<FIG> illustrates driver <NUM> having caused axle <NUM> to rotate in the first rotational direction R1. In <FIG>, the rotation of axle <NUM> in the first rotational direction R1 has caused first insertion needle <NUM> and second insertion needle <NUM> to extend from housing <NUM> such that first needle distal end <NUM> and second needle distal end <NUM> achieve positions outside of housing <NUM>. Further, in <FIG>, the rotation of axle <NUM> in the first rotational direction R1 has caused first insertion needle <NUM> to displace first medical device <NUM> from an initial position wherein first medical device <NUM> is within housing <NUM> (<FIG>) to an at least partially implanted position wherein at least some portion of first medical device <NUM> is outside of housing <NUM>. In <FIG>, the rotation of axle <NUM> in the first rotational direction R1 has also caused second insertion needle <NUM> to displace second medical device <NUM> from an initial position wherein second medical device <NUM> is within housing <NUM> (<FIG>) to an at least partially implanted position wherein at least some portion of second medical device <NUM> is outside of housing <NUM>.

Driver <NUM> may be configured such that, after driver <NUM> has caused first insertion needle <NUM> and second insertion needle <NUM> to extend from housing <NUM> (e.g., <FIG>), driver <NUM> causes first insertion needle <NUM> and second insertion needle <NUM> to retract into housing <NUM> (<FIG>). In examples, driver <NUM> is configured such that, after axle <NUM> has rotated in the first rotational direction R1 a certain amount (e.g., to extend insertion needles <NUM>, <NUM>), driver <NUM> causes axle <NUM> to subsequently rotate in the second rotational direction R2 (e.g., to retract insertion needles <NUM>, <NUM>). User input device <NUM> may be configured to cause driver <NUM> to extend and/or retract insertion needles <NUM>, <NUM>, such that the user may control the insertion and/or retraction.

In examples, driver <NUM> includes second spring <NUM> (<FIG>, <FIG>) configured to cause axle <NUM> to rotate relative to housing <NUM> in the second rotational direction R2 to cause the retraction of first insertion needle <NUM> and second insertion needle <NUM> into housing <NUM>. Second spring <NUM> may be configured to convert potential energy into kinetic energy to cause the rotation. For example, second spring <NUM> may be charged and/or put into a charged (e.g., wound or loaded) condition having a potential energy, and may convert some portion of the potential energy to kinetic energy (e.g., by fully or partially unwinding or unloading) to cause axle <NUM> to rotate in the second rotational direction R2. Insertion device <NUM> may be configured such that the full or partial unwinding of second spring <NUM> transitions insertion device <NUM> from the configuration of <FIG> to the configuration of <FIG>. In examples, second spring <NUM> is a torsion spring configured to rotate around axis L in the second rotational direction R2 when second spring <NUM> converts potential energy to kinetic energy. Second spring <NUM> may be mechanically engaged with axle <NUM>, such that rotation of second spring <NUM> around axis L in the second rotational direction R2 causes rotation of axle <NUM> in the second rotational direction R2. Second spring <NUM> may include a helical coil <NUM> ("second helical coil <NUM>") surrounding axis L and configured to rotate around axis L. In examples, second helical coil <NUM> surrounds axle <NUM>. Axle <NUM> may be mechanically engaged with second spring <NUM> (e.g., second helical coil <NUM>) such that, when second spring <NUM> rotates around axis L, spring <NUM> imparts a second torque around axis L to axle <NUM>. In examples, the second torque imparted by second spring <NUM> has a rotational direction substantially opposite the rotational direction of the first torque imparted by first spring <NUM>.

In examples, second spring <NUM> is a torsion spring having a primary end <NUM> ("second spring primary end <NUM>") and a second spring secondary end <NUM> ("second spring secondary end <NUM>"). The torsion spring may be configured to store potential energy by substantially winding (e.g., twisting around) a spring axis of second spring <NUM>, and may be configured to cause movement of second spring primary end <NUM> relative to second spring secondary end <NUM> as the torsion spring unwinds to expend the potential energy. The spring axis of second spring <NUM> may be substantially parallel to and/or coincident with axis L. Second spring <NUM> may be configured to exert the second torque on axle <NUM> when second spring primary end <NUM> moves relative to second spring secondary end <NUM>. In examples, second spring <NUM> is configured to cause second spring primary end <NUM> to move relative to second spring secondary end <NUM> in the rotational direction R4 around axis L when second spring <NUM> expends potential energy. The rotational direction R4 may be similar or substantially the same as second rotational direction R2.

In examples, insertion device <NUM> is configured to substantially prevent motion of second spring primary end <NUM> relative to second spring secondary end <NUM> as axle <NUM> to rotates in the first rotational direction, such that second spring <NUM> enters and/or remains in a wound condition. Stated differently, insertion device <NUM> may be configured to substantially prevent motion of second spring primary end <NUM> relative to second spring secondary end <NUM> as first spring <NUM> unwinds to rotate axle <NUM>.

For example, <FIG> illustrate an example driver <NUM> including first spring <NUM> and second spring <NUM>. First spring <NUM> includes first spring primary end <NUM> and first spring secondary end <NUM>. First helical coil <NUM> surrounds axle <NUM> and is mechanically engaged to axle <NUM> by fixation structure <NUM> ("first fixation structure <NUM>"), such that rotation of first helical coil <NUM> around axis L causes a rotation of axle <NUM> around axis L. Second spring <NUM> includes second spring primary end <NUM> and second spring secondary end <NUM>. Second helical coil <NUM> surrounds axle <NUM> and is mechanically engaged to axle <NUM> by fixation structure <NUM> ("second fixation structure <NUM>"), such that rotation of second helical coil <NUM> around axis L causes a rotation of axle <NUM> around axis L. First spring <NUM> is configured to cause axle <NUM> to rotate in the first rotational direction R1 when first spring primary end <NUM> moves relative to first spring secondary end <NUM>. Second spring <NUM> is configured to cause axle <NUM> to rotate in the second rotational direction R2 when second spring primary end <NUM> moves relative to second spring secondary end <NUM>. Axle <NUM> is configured to rotate around axis L. Axle <NUM>, first fixation structure <NUM>, and second fixation structure <NUM> are illustrated as cross-sections with a cutting plane parallel to the page.

<FIG> illustrates first spring <NUM> with support structure <NUM> engaged (e.g., mechanically engaged) with first spring secondary end <NUM> to substantially limit motion of first spring secondary end <NUM> with respect to housing <NUM>. Mechanical stop <NUM> is in a first position P1 to engage (e.g., mechanically engage) first spring primary end <NUM>, such that mechanical stop <NUM> substantially prevents movement of first spring primary end <NUM> relative to first spring secondary end <NUM> in the first position P1. A mechanical stop <NUM> is engaged (e.g., mechanically engaged) with second spring primary end <NUM> and a mechanical stop <NUM> is engaged (e.g., mechanically engaged) with second spring secondary end <NUM>. Mechanical stops <NUM>, <NUM> substantially prevent movement of second spring primary end <NUM> relative to second spring secondary end <NUM>.

<FIG> illustrates mechanical stop <NUM> having repositioned from the first position P1 to a second position P2. In the second position P2, mechanical stop <NUM> disengages from first spring <NUM> (e.g., first spring primary end <NUM>), such that the potential energy of first spring <NUM> may cause first spring primary end <NUM> to move relative to first spring secondary end <NUM>. <FIG> illustrates first spring primary end <NUM> having moved around axle <NUM> in the first rotational direction R1 relative to first spring secondary end <NUM>. The movement of first spring primary end <NUM> has caused first spring <NUM> to exert a first torque on axle <NUM>, causing axle <NUM> to rotate in the first rotational direction R1. Mechanical stops <NUM>, <NUM> are configured to rotate around axis L in the first rotational direction R1 when axle <NUM> rotates in the first rotational direction R1, such that mechanical stops <NUM>, <NUM> substantially prevent second spring <NUM> from unwinding to expend potential energy as axle <NUM> rotates in the first rotational direction R1. In <FIG>, mechanical stop <NUM> is in a first position P3 to engage second spring <NUM> (e.g., second spring primary end <NUM>) and substantially prevents movement of first spring primary end <NUM> relative to first spring secondary end <NUM>.

<FIG> illustrates mechanical stop <NUM> having repositioned from the first position P3 to a second position P4. In the second position P4, mechanical stop <NUM> disengages from second spring <NUM> (e.g., second spring primary end <NUM>), such that the potential energy of second spring <NUM> may cause second spring primary end <NUM> to move relative to second spring secondary end <NUM>. <FIG> illustrates second spring primary end <NUM> having moved around axle <NUM> in the second rotational direction R2 relative to second spring secondary end <NUM>. The movement of second spring primary end <NUM> has caused second spring <NUM> to exert a second torque on axle <NUM>, causing axle <NUM> to rotate in the second rotational direction R2.

Driver <NUM> may be configured to cause axle <NUM> to rotate in the first rotational direction R1 (e.g., to cause extension of insertion needles <NUM>, <NUM> (<FIG>, <FIG>, <FIG>)) and/or configured to cause axle <NUM> to rotate in the second rotation direction R2 (e.g., to cause retraction of insertion needles <NUM>, <NUM>). In examples, driver <NUM> is configured to cause the rotation in the second rotational direction R2 after axle <NUM> has rotated in the first rotational direction R1 by a certain amount. For example, driver <NUM> may include a limit switch <NUM> configured to cause second spring <NUM> to exert the second torque on axle <NUM> when axle <NUM> has rotated by the certain amount. In examples, limit switch <NUM> is configured to cause mechanical stop <NUM> to transition from the first position P3 to the second position P4 when axle <NUM> rotates the certain amount. Limit switch <NUM> may be, for example, a mechanical switch configured to be actuated by some portion of second spring <NUM> (e.g., second spring secondary end <NUM>) and/or axle <NUM> when axle <NUM> has rotated the certain amount. In other examples, limit switch <NUM> may be a proximity switch such as a magnetic switch configured by a proximity of second spring <NUM> and/or axle <NUM> to limit switch <NUM>. In some examples, limit switch <NUM> may be a position sensor configured to sense a position of second spring <NUM> and/or axle <NUM>.

Second spring <NUM> may be configured to cause axle <NUM> and thus first spring <NUM> to rotate in the second rotational direction R2. Insertion device <NUM> may be configured such that first spring <NUM> substantially rewinds (e.g., stores potential energy) when axle <NUM> rotates in the second rotational direction R2. In examples, second spring <NUM> is configured to cause first spring <NUM> to store potential energy when second spring <NUM> causes axle <NUM> to rotate in the second rotational direction. In some examples, first spring <NUM> has a first torsion spring rate over the certain amount of axle <NUM> rotation and second spring <NUM> has a second torsion spring rate over the certain amount of axle <NUM> rotation, and the second torsion spring rate of second spring <NUM> is greater than the first torsion spring rate of first spring <NUM>.

User input device <NUM> (<FIG>, <FIG>, <FIG>) may be configured to cause mechanical stop <NUM> to reposition from first position P1 to second position P2, such that driver <NUM> causes the extension of insertion needles <NUM>, <NUM>. User input device <NUM> may be configured to cause mechanical stop <NUM> to reposition from first position P3 to second position P4, such that driver <NUM> causes the retraction of insertion needles <NUM>, <NUM>. In examples, user input device <NUM> may be configured to cause mechanical stop <NUM> to reposition from first position P1 to second position P2, such that driver <NUM> causes the extension and/or retraction of insertion needles <NUM>, <NUM>. Further, although <FIG> illustrate rotations of axle <NUM> in the first rotational direction R1 and the second rotational direction R2 of about <NUM> degrees, driver <NUM> may be configured to cause rotation of axle <NUM> by any amount in the first rotational direction R1 and/or the second rotational direction R2. User input device <NUM> may be coupled with mechanical stop <NUM>, <NUM> wirelessly, electrically, mechanically or in any other effective way.

Driver <NUM> may use any elastic object configured to store mechanical energy as potential energy and configured to cause the rotation of axle <NUM> using an expenditure of the potential energy. Spring <NUM>, <NUM> may be any type of spring. For example, spring <NUM>, <NUM> may be torsion spring discussed above, a compression spring, a leaf spring, a spiral spring, a flat spring, a machined spring, a serpentine spring, a garter spring, or another type of spring configured to store potential energy. Spring <NUM>, <NUM> may be a constant force or variable force spring. Driver <NUM> may use any number of springs and any type of spring in any combination to cause the rotation of axle <NUM>.

Hence, insertion device <NUM> may be configured to cause insertion needles <NUM>, <NUM> to extend away from housing <NUM> and/or subsequently retract in a direction toward housing <NUM> when axle <NUM> rotates relative to housing <NUM>. In examples, insertion device <NUM> is configured to cause first insertion needle <NUM> to transition (e.g., along the path S1) from a first undeployed position (<FIG>) wherein first needle distal end <NUM> is within housing <NUM> to a first deployed position (<FIG>) wherein first needle distal end <NUM> is outside housing <NUM>. In examples, insertion device <NUM> is configured to cause second insertion needle <NUM> to transition (e.g., along the path S2) from a second undeployed position (<FIG>) wherein second needle distal end <NUM> is within housing <NUM> to a second deployed position (<FIG>) wherein second needle distal end <NUM> is outside housing <NUM>. Insertion device <NUM> may be configured to cause first insertion needle <NUM> to transition from the first deployed position to a first stowage position (<FIG>) wherein first needle distal end <NUM> is within housing <NUM>. Insertion device <NUM> may be configured to cause second insertion needle <NUM> to transition from the second deployed position to a second stowage position (<FIG>) wherein second needle distal end <NUM> is within housing <NUM>. The first stowage position may be a different position than the first undeployed position, or may be substantially the same position as the first undeployed position, and the second stowage position may be a different position that the second undeployed position, or may be substantially the same position as the second undeployed position.

Insertion device <NUM> may be configured and/or supported within housing <NUM> to cause the extension and/or retraction of first insertion needle <NUM> in any direction relative to housing <NUM>. Insertion device <NUM> may be configured and/or supported within housing <NUM> to cause the extension and/or retraction of second insertion needle <NUM> in any direction relative to housing <NUM>. Further, axle <NUM>, first insertion needle <NUM>, second insertion needle <NUM>, first spring <NUM>, second spring <NUM>, and/or other components of insertion device <NUM> may have any orientation relative to housing <NUM> and each other sufficient to cause the extension and/or retraction of first insertion needle <NUM> and second insertion needle <NUM>. Insertion device <NUM> may be configured to cause the extension and/or retraction of first insertion needle <NUM> and second insertion needle <NUM>, and at least partial implantation of first medical device <NUM> and second medical device <NUM>, at any angle relative to housing <NUM>. Insertion device <NUM> may be configured to cause the extension and/or retraction of first insertion needle <NUM> and second insertion needle <NUM>, and the at least partial implantation of first medical device <NUM> and second medical device <NUM> at any angle relative to the patient when insertion device <NUM> is proximate the skin <NUM> of the patient.

Insertion device <NUM> may be configured to cause the insertion of first insertion needle <NUM> substantially concurrently with second insertion needle <NUM>, and/or be configured to cause the insertion of first insertion needle <NUM> sequentially (e.g., before or after) relative to the insertion of second insertion needle <NUM>. Insertion device <NUM> may be configured to cause the retraction of first insertion needle <NUM> substantially concurrently with second insertion needle <NUM>, and/or be configured to cause the retraction of first insertion needle <NUM> sequentially (e.g., before or after) relative to the insertion of second insertion needle <NUM>.

As discussed, first insertion needle <NUM> may be configured to releasably engage first medical device <NUM> to cause the at least partial implantation of first medical device <NUM> within the patient. In examples, first medical device <NUM> is a fluid delivery cannula configured to deliver a fluid (e.g., insulin) to a user. First insertion needle <NUM> and the fluid delivery cannula may be cooperatively configured and arranged such that the first insertion needle <NUM> releasably carries at least a portion (e.g., a distal portion) of the fluid delivery cannula as first insertion needle <NUM> is caused to extend away from housing <NUM>. In some examples, first insertion needle <NUM> is configured to extend into lumen <NUM> of the fluid delivery cannula when first insertion needle <NUM> extends away from housing <NUM>. First insertion needle <NUM> and/or the fluid delivery cannula may be configured such that first insertion needle <NUM> mechanically engages the fluid delivery cannula when first insertion needle <NUM> (e.g., first needle distal end <NUM>) extends in a direction away from housing <NUM> and disengages from the fluid delivery cannula when first insertion needle <NUM> retracts in a direction toward housing <NUM>. (<FIG>, <FIG>).

In examples, when first insertion needle <NUM> is in the first undeployed position wherein first needle distal end <NUM> is within housing <NUM> (<FIG>)), insertion device <NUM> may be configured to maintain separation between first medical device <NUM> (e.g., the fluid delivery cannula) and first insertion needle <NUM>. For example, insertion device <NUM> may be configured to maintain separation between first insertion needle <NUM> and first medical device <NUM> using a first septum <NUM> (<FIG>, <FIG>). First septum <NUM> may be a self-sealing material across an aperture defined in first conduit <NUM>. Insertion device <NUM> may be configured such that, as first insertion needle <NUM> extends (e.g., along the path S1), insertion needle <NUM> (e.g., first distal end <NUM>) punctures first septum <NUM> prior to engaging first medical device <NUM>.

First insertion needle <NUM> may be configured to engage first medical device <NUM> to cause at least some portion of first medical device <NUM> to translate in a direction away from housing <NUM> (e.g., substantially along the path S1). First insertion needle <NUM> may be configured to exert a force on first medical device <NUM> in the direction away from housing <NUM> to cause the translation of first medical device <NUM>. For example, first insertion needle <NUM> and/or first medical device <NUM> may include a first structural feature configured to cause first insertion needle <NUM> to exert the force in the direction away from housing <NUM> on first medical device <NUM> when first insertion needle <NUM> (e.g., first distal end <NUM>) extends in the direction away from housing <NUM>. In examples, first insertion needle <NUM> is configured to enter lumen <NUM> to engage first medical device <NUM>. First insertion needle <NUM> may be configured to engage first medical device <NUM> to cause at least partial implantation of first medical device in the patient as first insertion needle <NUM> extends in the direction away from housing <NUM> into the patient. First medical device <NUM> (e.g., a fluid delivery cannula) may be configured to extend from device housing <NUM> when first insertion needle <NUM> causes the at least partial implantation of first medical device <NUM> within the patient. First insertion needle <NUM> may be configured to disengage from (e.g., release) first medical device <NUM> when first insertion needle <NUM> (e.g., first distal end <NUM>) is subsequently retracted in a direction toward housing <NUM> by insertion device <NUM>. For example, first insertion needle <NUM> and/or first medical device <NUM> may include a structural feature (the same as the first structural feature or a different structural feature) configured to allow first insertion needle <NUM> to move substantially independently of first medical device <NUM> when insertion device <NUM> retracts first insertion needle <NUM> toward housing <NUM>.

In examples, first insertion needle <NUM> is configured to substantially mate with first medical device <NUM> when a first insertion needle <NUM> exerts the force in the direction away from housing <NUM>. First insertion needle <NUM> may be configured such that a subsequent force toward housing <NUM> causes first insertion needle <NUM> to unmate (e.g., disengage) and move independently of first medical device <NUM>. In examples, first insertion needle <NUM> includes a bearing surface configured such that, when the force in the direction away from housing <NUM> is exerted on first insertion needle <NUM>, the bearing surface engages a portion of first medical device <NUM> and transmits some portion of the force to first medical device <NUM>, and when a force toward housing <NUM> is exerted on first insertion needle <NUM>, the bearing surface disengages the portion of first medical device <NUM>, such that first insertion needle <NUM> moves independently of first medical device <NUM>. Hence, insertion device <NUM> may be configured to retract first insertion needle <NUM> in the direction toward housing <NUM> independently from first medical device <NUM>, such that first medical device <NUM> remains at least partially implanted as first insertion needle <NUM> retracts.

Insertion device <NUM> may be configured to retract first insertion needle <NUM> to a first stowage position wherein first needle distal end <NUM> is within housing <NUM>. Insertion device <NUM> may retract first insertion needle <NUM> such that first needle distal end <NUM> retracts through first septum <NUM>. First septum <NUM> may be configured to self-seal when first needle distal end <NUM> retracts in order to establish a fluid-proof barrier between first conduit <NUM> and other components of therapy delivery device <NUM>, such as driver <NUM>, processor <NUM> including processing circuitry, memory element <NUM>, and other portions of therapy delivery device <NUM> which may be adversely impacted by contact with a fluid within first conduit <NUM>.

As discussed, second insertion needle <NUM> may be configured to releasably engage second medical device <NUM> to cause the at least partial implantation of second medical device <NUM> within the patient. In examples, second medical device <NUM> is an analyte sensor configured to monitor a physiological characteristic (e.g., a glucose level) of the user. Second insertion needle <NUM> and the analyte sensor may be cooperatively configured and arranged such that the second insertion needle <NUM> releasably carries at least a portion (e.g., a distal portion) of the analyte sensor as second insertion needle <NUM> (e.g., second needle distal end <NUM>) extends in a direction away from housing <NUM>. In some examples, second insertion needle <NUM> is configured to at least partially surround the analyte sensor to carry the analyte sensor as second insertion needle <NUM> extends away from housing <NUM>. Second insertion needle <NUM> may be configured as a partially hollow needle defining a void that accommodates the analyte sensor within the void. Second insertion needle <NUM> and/or the analyte sensor may be configured such that second insertion needle <NUM> mechanically engages the analyte sensor when second insertion needle <NUM> extends in the direction away from housing <NUM> and disengages from the analyte sensor when second insertion needle <NUM> retracts in a direction toward housing <NUM>.

Second insertion needle <NUM> may be configured to engage second medical device <NUM> to cause second medical device <NUM> to translate in the direction away from housing <NUM>. Second insertion needle <NUM> may be configured to exert a force on second medical device <NUM> in the direction away from housing <NUM> to cause the translation of second medical device <NUM>. Second insertion needle <NUM> and/or second medical device <NUM> may include a second structural feature (e.g., the void defined by second insertion needle) configured to cause second insertion needle <NUM> to exert the force on second medical device <NUM> when second insertion needle <NUM> extends in the direction away from housing <NUM>. Second insertion needle <NUM> may be configured to engage second medical device <NUM> to cause at least partial implantation of second medical device <NUM> in the patient as second insertion needle <NUM> extends in the direction away from housing <NUM>. Second medical device <NUM> (e.g., an analyte sensor) may be configured to extend from device housing <NUM> when second insertion needle <NUM> causes the at least partial implantation of second medical device <NUM> within the patient.

Second insertion needle <NUM> may be configured to disengage from (e.g., release) second medical device <NUM> when second insertion needle <NUM> is subsequently retracted in the direction toward housing <NUM>. For example, second insertion needle <NUM> and/or second medical device <NUM> may include a structural feature (the same as the second structural feature or a different structural feature) configured to allow second insertion needle <NUM> to move substantially independently of second medical device <NUM> when insertion device <NUM> retracts second insertion needle <NUM> toward housing <NUM>. In some examples, second insertion needle <NUM> is configured such that body tissue within the patient engages with second medical device <NUM> (e.g., the analyte sensor) when second insertion needle <NUM> retracts, such that second medical device <NUM> remains at least partially implanted in the patient when second insertion needle <NUM> is withdrawn from the patient. For example, second insertion needle <NUM> may include a portion (e.g., a distal portion) defining a longitudinal opening, such that a portion of the analyte sensor is exposed to body tissue when second insertion needle <NUM> and second medical device <NUM> are inserted in the patient. The body tissue may act to grip (e.g., frictionally engage) the exposed portion of the analyte sensor as second insertion needle <NUM> is retracted, such that second insertion needle <NUM> may be retracted into housing <NUM> as second medical device <NUM> remains at least partially implanted in the patient. In examples, second medical device <NUM> (e.g., an analyte sensor) may include one or more structural features configured to assist the frictional engagement with the body tissue.

In examples, therapy delivery device <NUM> may be configured to prevent ingress of bodily fluid into device <NUM> via hole <NUM>. This may protect portions of device <NUM> such as driver <NUM>, processor <NUM>, memory element <NUM>, and others portions of device <NUM> which may be adversely impacted by contact with a fluid from the user. In examples, device <NUM> includes second septum <NUM> (<FIG>) configured to maintain a fluid-proof barrier between the portions of device <NUM> and the hole <NUM>. Insertion device <NUM> may be configured such that, as second insertion needle <NUM> is extended in the direction away from housing <NUM>, second insertion needle <NUM> (e.g., second needle distal end <NUM>) punctures second septum <NUM>. Second septum <NUM> may be comprised of a self-sealing material, such that second septum <NUM> substantially closes around second insertion needle <NUM> and/or second medical device <NUM> to substantially maintain a fluid-proof barrier between the portions of device <NUM> and the patient.

Insertion device <NUM> may be configured to retract second insertion needle <NUM> to the second stowage position, wherein second distal end <NUM> is within housing <NUM>. Insertion device <NUM> may retract second insertion needle <NUM> such that second needle distal end <NUM> retracts through second septum <NUM>. Second septum <NUM> may be configured to self-seal (e.g., around second medical device <NUM>) when second needle distal end <NUM> retracts through second septum <NUM>, in order to substantially maintain a fluid-proof barrier between the components of device <NUM> and the patient.

As mentioned above, in some embodiments, insertion device <NUM> may be separate from and external to therapy delivery device <NUM>. Thus, housing <NUM> of insertion device <NUM> may be configured to couple with housing <NUM> of therapy delivery device <NUM> for insertion of medical devices <NUM> and <NUM> into the patient. For example, insertion device <NUM> may comprise driver <NUM>; axle <NUM>; and needles <NUM> and <NUM>, whereas therapy delivery device <NUM> may comprise first conduit <NUM>; septum <NUM>, and septum <NUM>; and medical devices <NUM> and <NUM>. Referring back to <FIG> for visual reference, housing <NUM> may be mounted on housing <NUM> such that second insertion needle <NUM> is aligned with second medical device <NUM>; septum <NUM>; and hole <NUM>, and such that first needle distal end <NUM> of first insertion needle <NUM> is aligned with septum <NUM>.

Second medical device <NUM> may be fabricated using a flexible or pliable substrate or carrier. In examples, second medical device <NUM> (e.g., an analyte sensor) may be coupled to conductive wires that are initially provided in a folded, serpentine, coiled, or accordion shape to, for example, provide a desired amount of slack to accommodate extension of second medical device <NUM> while second medical device <NUM> is electrically coupled to insertion device <NUM> (e.g., to electronic assembly <NUM> (<FIG>). Second medical device <NUM> may be configured such that, as second insertion needle <NUM> carries second medical device <NUM> in a distal direction away from housing <NUM> (e.g., along the path S2), second medical device <NUM> extends without losing electrical contact with the electronics assembly <NUM>. In some examples, second medical device <NUM> is configured to establish electrical coupling (e.g., with electronics assembly <NUM>) after insertion device <NUM> has been triggered. For example, second medical device <NUM> may include electrical contact pads configured to electrically connect with one or more connectors of device <NUM> as or when second insertion needle <NUM> at least partially implants second medical device <NUM> within the patient.

A technique for at least partially implanting a first medical device and a second medical device is illustrated in <FIG>. Although the technique is described mainly with reference to the various devices of <FIG>, the technique may be applied to other devices in other examples.

The technique include using a first insertion needle <NUM> to carry a distal end of a first medical device <NUM> along a curved path S1 through a hole <NUM> in an apparatus housing <NUM>.

The technique may include rotating an axle <NUM> with respect to housing <NUM>. Axle <NUM> may be rotated around a longitudinal axis L in a first rotational direction R1. Axle <NUM> may be rotated using a driver <NUM>. The technique may include rotating axle <NUM> in the first rotational direction R1 using a first torque imparted by driver <NUM>. In examples, driver <NUM> includes a first spring <NUM>. The technique may include exerting the first torque on axle <NUM> using first spring <NUM>.

The technique includes using a second insertion needle <NUM> to carry a second medical device <NUM> through hole <NUM> (<NUM>). The technique may include inserting second insertion needle <NUM> such that a distal end of second medical device <NUM> becomes increasingly displaced from the distal end of first medical device <NUM> as the distal end of first medical device <NUM> is carried along the curved path.

The technique may include extending first insertion needle <NUM> and second insertion needle <NUM> through hole <NUM> using the rotation of axle <NUM> in the first rotational direction R1. The technique may include extending the first insertion needle <NUM> and second insertion needle <NUM> in a direction away from housing <NUM>. In examples, the technique includes moving a first needle distal end <NUM> from a first undeployed position within housing <NUM> to a first deployed position outside of housing <NUM> using the rotation of axle <NUM> in the first rotational direction R1. The technique may include causing first needle distal end <NUM> to move along a path S1. In examples, the technique includes moving a second needle distal end <NUM> from a second undeployed position within housing <NUM> to a second deployed position outside of housing <NUM> using the rotation of axle <NUM> in the first rotational direction R1. The technique may include causing second needle distal end <NUM> to move along a path S2. In examples, the path S1 has a first curvature relative to axis L and the path S2 has a second curvature relative to axis L, and the first curvature is greater than the second curvature. In examples, the path S2 is a substantially linear path.

The technique may include exerting a torque around longitudinal axis L on first insertion needle <NUM> when the axle rotates in the first rotational direction R1. In examples, first insertion needle <NUM> is a curved needle. The technique may include causing first needle distal end <NUM> to travel along the path S1 using the torque exerted on first insertion needle <NUM>. In examples, insertion device <NUM> includes a strut <NUM> configured to transmit the torque from axle <NUM> to first insertion needle <NUM>. In examples, insertion device <NUM> includes a pinion gear coupled to axle <NUM> and a curved rack gear coupled to first insertion needle <NUM> such that the pinion gear meshes with the curved rack gear to transfer the torque from axle <NUM> to first insertion needle <NUM>. In examples, a surface of axle <NUM> is configured to frictionally engage a surface of first insertion needle <NUM> to transfer the torque from axle <NUM> to first insertion needle <NUM>.

The technique may include exerting a substantially linear force on second insertion needle <NUM> when the axle rotates in the first rotational direction R1. In examples, second insertion needle <NUM> is a substantially straight needle. The technique may include causing second needle distal end <NUM> to travel along the path S2 using the substantially linear force exerted on second insertion needle <NUM>. In examples, insertion device <NUM> is configured to cause a pinion gear <NUM> to rotate around longitudinal axis L. Pinion gear <NUM> may be configured to mesh with a rack gear <NUM> coupled with second insertion needle <NUM> to exert the substantially linear force on second insertion needle <NUM>. In examples, a surface of axle <NUM> is configured to frictionally engage a surface of second insertion needle <NUM> to transfer the substantially linear force to second insertion needle <NUM>.

In examples, the technique includes causing first needle distal end <NUM> and second needle distal end <NUM> to extend through a hole <NUM> defined by housing <NUM>. In examples, the technique includes causing first needle distal end <NUM> and/or second needle distal end <NUM> to pierce the skin <NUM> of the user. The technique may include causing first needle distal end <NUM> and second needle distal end <NUM> to insert through the skin <NUM> of the user within an insertion site <NUM> on the skin <NUM> of the user. In examples, the technique includes piercing the skin <NUM> at a puncture site with one of the first insertion needle <NUM> or the second insertion needle <NUM>, and inserting the other of the first insertion needle <NUM> or the second insertion needle <NUM> through the skin <NUM> at the puncture site.

The technique may include at least partially implanting a first medical device <NUM> in the user by extending first insertion needle <NUM>, and at least partially implanting a second medical device <NUM> in the user by extending second insertion needle <NUM>. In examples, first medical device <NUM> is a fluid delivery cannula configured to the delivery of a medical fluid (e.g., insulin). In examples, second medical device <NUM> is an analyte sensor (e.g., a glucose sensor) configured to sense a physiological characteristic of the user (e.g., a glucose level). In examples, insertion device <NUM> is configured to cause the at least partial implantations such that first medical device <NUM> and second medical device <NUM> are separated by a displacement D when at least partially implanted in the user.

The technique may include rotating axle <NUM> in a second rotational direction R2 substantially opposite the first rotational direction R1. The technique may include retracting first insertion needle <NUM> and a second insertion needle <NUM> using the rotation of axle <NUM> in the second rotational direction R2. The technique may include retracting first insertion needle <NUM> and second insertion needle <NUM> in a direction toward housing <NUM>. In examples, the technique includes moving first needle distal end <NUM> from the first deployed position to a first stowage position inside of housing <NUM> using the rotation of axle <NUM> in the second rotational direction R2. The technique may include causing first needle distal end <NUM> to move along the path S1. In examples, the technique includes moving second needle distal end <NUM> from the second deployed position to a second stowage position inside of housing <NUM> using the rotation of axle <NUM> in the second rotational direction R2. The technique may include causing second needle distal end <NUM> to move along a path S2.

The technique may include exerting a torque around longitudinal axis L on first insertion needle <NUM> when the axle rotates in the second rotational direction R2. The technique may include causing first needle distal end <NUM> to travel along the path S1 using the second torque exerted on first insertion needle <NUM>. The technique may include exerting a substantially linear force on second insertion needle <NUM> when axle <NUM> rotates in the second rotational direction R2. The technique may include causing second needle distal end <NUM> to travel along the path S2 using the substantially linear force exerted on second insertion needle <NUM>.

The technique includes retracting first insertion needle <NUM> toward housing <NUM> to withdraw first insertion needle <NUM> from the user using the rotation of axle <NUM> in the second rotational direction R2. In examples, the technique includes causing first insertion needle <NUM> to release first medical device <NUM> when first insertion needle <NUM> retracts toward housing <NUM>. The technique may include mechanically disengaging first insertion needle <NUM> from first medical device <NUM> such that first medical device <NUM> remains at least partially implanted in the user when first insertion needle <NUM> retracts toward housing <NUM>. The technique may include causing first insertion needle <NUM> to move independently of first medical device <NUM> during the retraction of first insertion needle <NUM> such that first medical device <NUM> remains at least partially implanted in the user when first insertion needle <NUM> retracts toward housing <NUM>.

The technique includes retracting second insertion needle <NUM> toward housing <NUM> to withdraw second insertion needle <NUM> from the user using the rotation of axle <NUM> in the second rotational direction R2. In examples, the technique includes causing second insertion needle <NUM> to release second medical device <NUM> when second insertion needle <NUM> retracts toward housing <NUM>. The technique may include mechanically disengaging second insertion needle <NUM> from second medical device <NUM> such that second medical device <NUM> remains at least partially implanted in the user when second insertion needle <NUM> retracts toward housing <NUM>. The technique may include causing second insertion needle <NUM> to move independently of second medical device <NUM> during the retraction of second insertion needle <NUM> such that second medical device <NUM> remains at least partially implanted in the user when second insertion needle <NUM> retracts toward housing <NUM>.

The technique may include rotating axle <NUM> by exerting a torque on axle <NUM> using a spring. In examples, the technique includes rotating axle <NUM> in the first rotational direction R1 by exerting a torque on axle <NUM> in the first rotational direction R1 using a first spring <NUM>. In examples, the technique includes rotating axle <NUM> in the second rotational direction R2 by exerting a torque on axle <NUM> in the first rotational direction R2 using a second spring <NUM>. In examples, the technique includes initially rotating axle <NUM> in the first rotational direction R1 and subsequently rotating axle <NUM> in the second rotational direction R2. In examples, driver <NUM> is configured to initially rotate axle <NUM> in the first rotational direction R1 and subsequently rotate axle <NUM> in the second rotational direction R2.

In examples, the technique includes actuating driver <NUM> using user input device <NUM> to cause the at least partial implantations of first medical device <NUM> and second medical device <NUM>. In examples, user input device <NUM> is configured to cause driver <NUM> to rotate axle <NUM> in the first rotational direction R1. In examples, user input device <NUM> is configured to cause driver <NUM> to rotate axle <NUM> in the second rotational direction R2. In examples, user input device <NUM> is configured to cause driver <NUM> to initially rotate axle <NUM> in the first rotational direction R1 and subsequently rotate axle <NUM> in the second rotational direction R2. In some examples, the technique includes depressing a button on housing <NUM> to cause user input device <NUM> to initiate the at least partial implantation of first medical device <NUM> and second medical device <NUM>. In some examples, the technique includes transmitting an electrical communication to user input device <NUM> (e.g., a wired or wireless communication) to initiate the at least partial implantation of first medical device <NUM> and second medical device <NUM>.

Housing <NUM> may be configured to support at least driver <NUM>, first insertion needle <NUM>, and second insertion needle <NUM>. Housing <NUM> may be configured to engage (e.g., mechanically engage) device housing <NUM> of therapy delivery device <NUM>. The technique may including positioning at least first insertion needle <NUM> and second insertion needle <NUM> proximate the skin <NUM> of the user by mounting housing <NUM> atop housing <NUM>. The technique may include separating housing <NUM> and housing <NUM> when first medical device <NUM> and second medical device <NUM> are at least partially implanted within the user.

The techniques and functionalities described in this disclosure, including those attributed to processor <NUM>, processing circuitry, sensors, and/or various constituent components, may be implemented, at least in part, in hardware, software, firmware or any combination thereof. For example, various aspects of the techniques may be implemented within one or more processors, including one or more microprocessors, DSPs, ASICs, FPGAs, or any other equivalent integrated or discrete logic circuitry, as well as any combinations of such components, embodied in any suitable device. Processing circuitry, control circuitry, and sensing circuitry, as well as other processors, controllers, and sensors described herein, may be implemented at least in part as, or include, one or more executable applications, application modules, libraries, classes, methods, objects, routines, subroutines, firmware, and/or embedded code, for example. In addition, analog circuits, components and circuit elements may be employed to construct one, some or all of the control circuitry and sensors, instead of or in addition to the partially or wholly digital hardware and/or software described herein. Accordingly, analog or digital hardware may be employed, or a combination of the two.

In one or more examples, the techniques and functionalities described in this disclosure may be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functions may be stored on, as one or more instructions or code, a computer-readable medium and executed by a hardware-based processing unit. The computer-readable medium may be an article of manufacture including a non-transitory computer-readable storage medium encoded with instructions. Instructions embedded or encoded in an article of manufacture including a non-transitory computer-readable storage medium encoded, may cause one or more programmable processors, or other processors, to implement one or more of the techniques described herein, such as when instructions included or encoded in the non-transitory computer-readable storage medium are executed by the one or more processors. Example non-transitory computer-readable storage media may include RAM, ROM, programmable ROM (PROM), erasable programmable ROM.

(EPROM), electronically erasable programmable ROM (EEPROM), flash memory, a hard disk, a compact disc ROM (CD-ROM), a floppy disk, a cassette, magnetic media, optical media, or any other computer readable storage devices or tangible computer readable media.

In some examples, a computer-readable storage medium comprises non-transitory medium. The term "non-transitory" may indicate that the storage medium is not embodied in a carrier wave or a propagated signal. In certain examples, a non-transitory storage medium may store data that can, over time, change (e.g., in RAM or cache).

Claim 1:
An apparatus comprising:
a first insertion needle (<NUM>) configured to carry a distal end of a first medical device (<NUM>) along a curved path that passes through an opening (<NUM>) in the apparatus housing (<NUM>); and
a second insertion needle (<NUM>) configured to carry a distal end of a second medical device (<NUM>) through the opening (<NUM>) in the apparatus housing (<NUM>),
wherein the first insertion needle (<NUM>) carries the distal end of the first medical device (<NUM>) such that the distal end of the first medical device (<NUM>) becomes increasingly displaced from the distal end of the second medical device (<NUM>) as the distal end of the first medical device (<NUM>) is carried along the curved path.