Single site insertion of multiple medical devices

Abstract

In some embodiments, an apparatus can include a first insertion needle and a second insertion needle. The first insertion needle can be configured to carry a first medical device (e.g., a sensor) through an opening in an apparatus housing. The second insertion needle can be configured to carry a second medical device (e.g., a cannula) along a curved path through the opening in the apparatus housing such that a distal end of the first medical device increasingly moves away from a distal end of the second medical device as the distal end of the second medical device is carried along the curved path.

Description

TECHNICAL FIELD

[0001] The present disclosure relates generally to insertion techniques for medical devices. BACKGROUND

[0002] According to modern medical techniques, certain diseases or conditions can be treated by delivering a drug fluid or other substance to a patient's body in a continuous manner or at specific times or time intervals throughout a time period. For example, diabetes is often treated by delivering a defined amount of insulin to a 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. In addition, in some cases, the patient can also desire to receive information from a physiological property monitor, such as a glucose monitor. In these cases, the physiological property monitor and the cannula are typically coupled to the user's anatomy at different insertion sites, respectively, such that the insulin delivered via the cannula does not interfere with the measurements made by the physiological property monitor. SUMMARY

[0003] The present disclosure relates generally to a first insertion needle and a second insertion needle configured to transport a first medical device and a second medical device, respectively, through an opening in a device housing. The second insertion needle can be configured to transport the second medical device along a curved path through the opening such that a distal end of the first medical device is increasingly distanced from a distal end of the second medical device as the distal end of the second medical device is transported along the curved path.

[0004] The details of one or more examples are set forth in the accompanying drawings and the description below. Other features, objects, and advantages will be apparent from the description and drawings, and from the claims. BRIEF DESCRIPTION OF DRAWINGS

[0005] Figure 1 is a top perspective view of an example therapy delivery device.

[0006] Figure 2 is a bottom perspective view of the therapy delivery device of Figure 1

[0007] Figure 3 is a schematic side view of an example therapy delivery device attached to a user's body.

[0008] Figure 4 is a simplified block diagram representation of an example therapy delivery device.

[0009] Figure 5A is a schematic view of an example insertion device in an un-deployed configuration;

[0010] Figure 5B is a schematic view of the insertion device of Figure 5A in a deployed configuration.​

[0011] Figure 5C is in a stowed configuration Figure 5A and Figure 5B schematic view of an example insertion device.

[0012] Figure 6 is a perspective view of an example insertion device.

[0013] Figure 7A is a schematic view of an example insertion device in a first configuration;

[0014] Figure 7B is a schematic view of an example insertion device in a second configuration. Figure 7A

[0015] Figure 7C is a schematic view of an example insertion device in a third configuration. Figure 7A and Figure 7B

[0016] Figure 8 Example techniques of using an insertion device are shown.

[0017] Although different figures use the same numbers, the figures should not be interpreted to depict identical elements. For example, Figure 2 element 100 of Figure 3 element 100 of DETAILED DESCRIPTION

[0018] The present 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) into a patient via a same insertion site on the patient. At least the second medical device can be inserted into the patient along a curved path through the insertion site and into the patient. Inserting the second medical device along the curved path enables a distal end of the second medical device to increasingly diverge away from a distal end of the first medical device. Among other benefits, the techniques implemented by the insertion device can reduce or avoid interference between the medical devices while reducing discomfort to the patient.

[0019] The insertion device can facilitate use of a therapy delivery device (e.g., a fluid infusion device) configured to provide a therapy fluid to a user (e.g., a patient) and monitor a physiological characteristic of the user. For example, the first medical device can be a fluid delivery cannula configured to deliver a fluid (e.g., insulin) to the user. The second medical device can be an analyte sensor (e.g., a glucose sensor) configured to detect a physiological characteristic (e.g., a glucose level) of the user. The insertion device can be configured to substantially simultaneously insert the first medical device and the second medical device into the user. In an example, the therapy delivery device is a portable system configured to be worn by the user.​​

[0020] The therapy delivery device can include a housing configured to be positioned in close proximity to the skin of a user. In examples, the housing is configured to contact the skin of the user. The housing can be configured to be substantially fixed to one location of the user such that, for example, mobility of the user is allowed when the therapy delivery device administers and monitors therapy delivered to the user. For example, when the therapy delivery device delivers insulin to the user through a fluid delivery cannula (e.g., a first medical device) and monitors glucose levels of the user using an analyte sensor (e.g., a second medical device), the therapy delivery device can be configured to allow a degree of user mobility. The therapy delivery device can be substantially fixed to the user using any suitable arrangement. In some examples, the housing of the therapy delivery device includes an adhesive element configured to removably fix the housing to the skin of the user.

[0021] In examples, the therapy delivery device is configured such that, when positioned on the skin of the user, the user can initiate implantation of at least a portion of the first medical device and the second medical device. For example, the user can initiate implantation of at least a portion using a manually operated button on the housing, a wireless communication to the therapy delivery device, or some other user-controlled activation.

[0022] The insertion device can be internal / external to the therapy delivery device. In other words, in some embodiments, the insertion device can be included within the housing of the therapy delivery device, and in some other embodiments, the insertion device can be included within a second housing that can be engaged and disengaged from the housing of the therapy delivery device as needed. The insertion device can be configured to extend the first insertion needle and the second insertion needle through an opening in the therapy delivery device housing to at least partially implant the first and second medical devices into the patient. The insertion device can 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 in the patient.

[0023] The first and second insertion needles can be configured to be inserted through and withdrawn from the patient's skin. The first insertion needle and / or the second insertion needle can be configured to pierce the patient's skin. Upon activation by a user, the insertion device can 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 subsequently to retract toward the therapy delivery device housing to withdraw from the skin. In some embodiments, the first insertion needle can be integrally formed 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 can 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 in the patient during its retraction. In some embodiments, the second insertion needle can be integrally formed 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 can 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. In an example, the insertion device is configured to cause at least partial implantation of the first medical device and the second medical device substantially simultaneously.

[0024] The insertion device can be configured to cause the first insertion needle and the second insertion needle to be inserted through the patient's skin at a single insertion site on the patient. The insertion site can be a relatively small area on the patient's skin. Using the same insertion site can reduce the number of punctures distributed across the skin. The insertion device can be configured to cause the first insertion needle and the second insertion needle to be inserted substantially simultaneously in order to, for example, limit discomfort to the patient that might otherwise result from multiple insertions at different times.

[0025] 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 can also be displaced within the patient from the distal end of the second medical device. In an example, 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 the second insertion needle to extend in a second, different direction away from the therapy delivery device housing. This displacement can reduce negative effects that can occur due to the proximity between the first medical device and the second medical device. For example, displacement between the distal end of the fluid delivery cannula and the analyte sensor can help prevent readings reported by the analyte sensor (e.g., glucose levels) from being adversely affected by fluid (e.g., insulin) being delivered through the fluid delivery cannula.

[0026] A therapy delivery device can include a variety of internal components configured to use a first medical device and a second medical device to provide therapy and monitor a physiological characteristic of a user. In an example, 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 fluid (e.g., insulin) from a fluid reservoir within the therapy delivery device to the user. The fluid reservoir can be, for example, a volume defined by a removable fluid cartridge configured to mechanically engage a housing of the therapy delivery device and establish a fluid connection with the fluid pump. In an example, the therapy delivery device includes processing circuitry configured to control operation of the fluid pump. For example, the processing circuitry can be configured to cause the fluid pump to begin, continue, and / or stop transporting fluid from the fluid reservoir through the fluid delivery cannula. In an example, the first medical device and / or the second medical device is an analyte sensor configured to generate a signal indicative of a physiological characteristic (e.g., a glucose level) of the user, 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 operation of the fluid pump based on the indicative signal reported by the analyte sensor.

[0027] The insertion device can include one or more shafts, and each shaft can be configured to rotate about a respective longitudinal axis of rotation. Each shaft can be configured to rotate about the axis of rotation in a first rotational direction and a second rotational direction, where the second rotational direction is opposite the first rotational direction. For example, a shaft can be configured to cause the first insertion needle and the second insertion needle to extend away from the therapy delivery device housing for insertion through the skin when the shaft is rotated in the first rotational direction. The shaft can also be configured to cause the first insertion needle and the second insertion needle to retract toward the therapy delivery device housing when the shaft is rotated in the second rotational direction. In an example, a first shaft can be configured to rotate about a first axis of rotation to cause insertion and / or retraction of the first insertion needle, and a second shaft can be configured to rotate about a second axis of rotation parallel to the first axis to cause insertion and / or retraction of the second insertion needle. The first shaft can be configured to rotate a first circular gear, and the second shaft can be configured to rotate a second circular gear. The circular gears can be meshed such that the shafts rotate in opposite directions.

[0028] One or more shafts can be configured to substantially drive the first insertion needle and the second insertion needle for insertion through the skin. In an example, the first insertion needle and / or the second insertion needle define a curved path as the one or more shafts drive the first insertion needle and the second insertion needle. For example, the first insertion needle can be a curved needle that is curved substantially about an axis of rotation of the shaft. The first insertion needle can be configured such that a distal end of the first insertion needle ("first needle distal end") substantially traces a curved path (e.g., a circular path) relative to the axis of rotation of the shaft as the first insertion needle is driven through the skin. In an example, the first insertion needle is configured such that the curved path of the first needle distal end displaces the first needle distal end from a distal end of the second insertion needle ("second needle distal end"). For example, the first insertion needle can be a curved needle having a first curvature, and the second insertion needle can be a curved needle having a second curvature that is equal in magnitude but opposite in direction to the first curvature. Thus, the first and second insertion needles can pierce the skin at the same site, but symmetrically diverge as they are further inserted beneath the skin.

[0029] In an example, one of the first insertion needle or the second insertion needle defines a path having 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 can be a substantially straight needle configured to exhibit linear motion relative to the therapy delivery device as the shaft drives the first insertion needle and the second insertion needle. The second insertion needle can be configured such that a distal end of the second needle ("second needle distal end") substantially traces a straight path relative to the therapy delivery device housing as the shaft drives the second insertion needle through the skin. Thus, as rotation of the shaft causes insertion of the first insertion needle and the second insertion needle, the substantially curved path defined by one insertion needle (e.g., the first insertion needle) and the path having reduced curvature (e.g., substantially straight) 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 insertion. This divergence can result in an increase in displacement between the distal end of the first medical device and the distal end of the second medical device as the first medical device and the second medical device are further inserted into the user.

[0030] The shaft can be configured to apply torque to the bend needle (e.g., the first insertion needle) in a variety of ways. In examples, the shaft is operably connected to the bend needle using, for example, a strut attached to the shaft and to the bend needle. In some examples, the shaft is directly attached to the bend needle. In some examples, a surface of the shaft is configured to frictionally engage a surface of the bend needle to apply torque to the bend needle. In some examples, the shaft can be configured to rotate a pinion gear that is in mesh with a bend rack gear coupled to the bend needle. Thus, when the shaft is rotated about its axis of rotation, the bend needle can also be rotated about the axis of rotation. The shaft can be configured to apply torque to the bend needle in a first rotational direction and / or a second rotational direction. In examples, the shaft is configured to apply torque to the bend needle in a first rotational direction to cause the bend needle to be inserted through the patient's skin, and is configured to apply torque to the bend needle in a second rotational direction to cause the bend needle to be withdrawn from the patient's skin.

[0031] The shaft can be configured to move a substantially straight needle (e.g., the second insertion needle) substantially linearly relative to the therapy delivery device housing. The shaft and the substantially straight needle can be cooperatively configured to convert rotation of the shaft to linear movement of the substantially straight needle relative to the therapy delivery device housing. In examples, the shaft is configured to rotate a pinion gear that is in mesh with a substantially straight rack gear coupled to the substantially straight needle, such that rotation of the pinion gear causes linear movement of the substantially straight needle. In examples, a surface of the shaft is configured to frictionally engage a surface of the substantially straight needle to cause linear movement of the substantially straight needle.

[0032] The insertion device can include torsion springs configured to rotate the shaft. For example, the insertion device can include one or more loaded torsion springs that are configured to become unloaded when the user activates the insertion device. In examples, the insertion device includes a first torsion spring configured to rotate the shaft in a first rotational direction, and a second torsion spring configured to rotate the shaft in a second rotational direction. The insertion device can be configured such that the first torsion spring causes rotation of the shaft in the first rotational direction (e.g., to insert the first and second insertion needles) and such that the second torsion spring subsequently causes rotation of the shaft in the second rotational direction (e.g., to retract the first and second insertion needles).

[0033] 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 rotation in the second rotational direction. For example, the insertion device can be configured such that rotation in the first rotational direction applies a load to the second torsion spring. The second torsion spring can then become unloaded to cause rotation of the shaft in the second rotational direction. In some examples, the insertion device is configured to disengage one or more mechanical stops that engage the second torsion spring after a certain amount of rotation in the first rotational direction, such that the second torsion spring can become unloaded to cause rotation of the shaft in the second rotational direction.

[0034] Accordingly, the therapy delivery device can be positioned in close proximity to the skin of a user, and the insertion device can extend the first insertion needle and the second insertion needle away from the therapy delivery device housing for insertion through the skin, and / or retract toward the therapy delivery device housing for withdrawal from the skin. The first insertion needle can be configured to at least partially implant a first medical device into the user, and the second insertion needle can be configured to at least partially implant a second medical device into the user. The insertion device can be operably connected to a user input device configured to allow a user to control when the insertion device causes implantation of at least portions of the first medical device and the second medical device. In an example, the first medical device is a fluid delivery cannula and the second medical device is an analyte sensor. The therapy delivery device can include a fluid pump (e.g., an insulin pump) configured to deliver a fluid (e.g., insulin) to the user, and can include a receiver configured to receive a signal from the analyte sensor indicative of a physiological characteristic (e.g., glucose level) of the user. Processing circuitry can be configured to control operation of the fluid pump based on the received signal indicative from the analyte sensor. The therapy delivery device can be used to administer a variety of medications to a user, such as but not limited to disease treatments, medications for treating pulmonary arterial hypertension, iron chelation medications, pain medications, anti-cancer treatments, medications, vitamins, hormones, etc.

[0035] Figure 1 is a top perspective view of an example therapy delivery device 100 configured as a fluid infusion device. The fluid infusion device can be implemented as a patch pump device. Figure 2 is a bottom perspective view of the therapy delivery device 100. Figure 3 is a schematic side view of the example therapy delivery device 100 in contact with a user’s body 101. Figure 1 、 Figure 2 and Figure 3 depict some possible form factors and shapes of the therapy delivery device 100. Other designs and form factors can be utilized if desired, and the examples disclosed herein are not intended to be limited or otherwise bound by the specific design aspects shown and / or described in Figure 1 、 Figure 2 、 Figure 3 and elsewhere. The specific design aspects shown and / or described are not intended to limit or otherwise bind the scope or application of the examples disclosed herein.

[0036] The therapy delivery device 100 includes a device housing 102, which can serve as an enclosure for various internal components of the therapy delivery device 100. For example, the device housing 102 can mechanically support one or more internal components configured to monitor physiological characteristics of a user and / or deliver therapy to the user. In an example, the device housing 102 is configured to mechanically support one or more insertion needles configured to insert one or more medical devices into the user. The device housing 102 can mechanically support one or more components configured to cause the one or more insertion needles to insert the medical devices into the user. In some examples, the device housing 102 is configured to mechanically support internal components configured to utilize and / or communicate with the medical devices to monitor the user and / or deliver therapy to the user. For example, the device housing 102 can 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 fluid to be delivered from a fluid reservoir through the fluid delivery cannula, and a processing circuit configured to communicate with the analyte sensor and / or the fluid pump. The device housing 102 can be configured to position the therapy delivery device 100 in close proximity to and / or in contact with the skin of the user.

[0037] In an example, the device housing 102 can be configured to mechanically support a removable fluid cartridge 104 that defines a fluid reservoir. The fluid cartridge 104 can be, for example, a disposable insulin cartridge. The device housing 102 can be suitably configured to receive, secure, and release the fluid cartridge 104. For example, Figure 1 and Figure 2 A fluid cartridge 102 is depicted mounted and substantially secured within the device housing 102. The device housing 102 can be configured such that, when the fluid cartridge 104 is mechanically supported by (e.g., mounted within) the device housing 102, a fluid pump mechanically supported by the device housing 102 establishes a fluid connection with the fluid reservoir defined by the fluid cartridge 104. The device housing 102 can include a cavity having a suitable shape, size, and configuration configured to engage specific physical characteristics of the fluid cartridge 104. For example, the device housing 102 can include structural features that mate with or otherwise engage structural features of the fluid cartridge 104.

[0038] The fluid cartridge 104 can have any shape, size, and / or configuration sufficient to engage with the device housing 102. In an example, the fluid cartridge 104 includes a cartridge retention mechanism 106 configured to secure the fluid cartridge 104 in a mounted and seated position within the therapy delivery device 100. The retention mechanism 106 can mechanically engage the device housing 102 to substantially lock the fluid cartridge 104 in place to maintain a physical and / or fluidic connection between the fluid cartridge 104 and one or more components of the therapy delivery device 100. The retention mechanism 106 can be configured to allow a user to physically manipulate to remove and / or install the fluid cartridge 104.

[0039] In some embodiments, the therapy delivery device 100 includes at least one user input device 108 that can be actuated by a user as needed. The user input device 108 can be a manually operated button on the device housing 102; circuitry configured to receive communications (e.g., wireless communications) from a smartphone, tablet, or other external device; and / or some other device configured to receive user input. In an example, the user input device 108 (e.g., a button) is configured to cause an insertion device to insert a first medical device and / or a second medical device into a user. In some embodiments, the user input device 108 can provide a multi-purpose user interface configured to initiate a plurality of operations of the therapy delivery device 100. For example, the user input device 108 can be configured to cause one or more of the following functions, but is not limited thereto: wake up a processor and / or electronic components of the therapy delivery device 100; trigger 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 user’s subcutaneous space or similar region; configure one or more settings of the therapy delivery device 100; initiate delivery of a medicament fluid; initiate a fluid priming operation; disable a warning or alarm generated by the therapy delivery device 100, etc. Instead of a button, the user input device 108 can employ a slider mechanism, pin, lever, switch, touch-sensitive element, etc.

[0040] The user input device 108 can be configured to receive communications (e.g., wireless communications) from a device remote from the device housing 102 to initiate performance of one or more of the above-described functions or other functions. In an example, the therapy delivery device 100 includes more than one user input device 108 (e.g., more than one button) to initiate the various functions described above.

[0041] In an example, the therapy delivery device 100 is a portable device. The therapy delivery device 100 can be a wearable device configured to be worn by a user. As Figure 2As depicted, the therapy delivery device 100 can include an adhesive element 110 or adhesive material configured to substantially affix the device housing 102 to a user's body. The adhesive element 110 can be configured to substantially secure the therapy delivery device 100 to the user's skin 118 Figure 3 ). The adhesive element 110 can be located on a bottom surface of the device housing 102 such that the device housing 102 can be temporarily adhered to the user's skin. The adhesive element 110 can substantially cover the entire bottom surface (as shown), or it can only partially cover the bottom surface, as desired. The adhesive element 110 can be, for example, a double-sided adhesive tape cut to a desired shape and size. In some examples, the therapy delivery device 100 is manufactured with an adhesive liner covering the adhesive element 110, and the adhesive liner is peeled away to expose the adhesive surface of the adhesive element 110.

[0042] The device housing 102 can include a base surface 112 (which is covered by the adhesive element 110 in Figure 2 ). The base surface 112 can be configured to serve as a user mounting structure for the therapy delivery device 100. In examples, the base surface 112 includes at least one aperture 114 that forms an opening through the device housing 102. When the adhesive element 110 covers some portion of the base surface 112, the aperture 114 can also form an opening through the adhesive element 110.

[0043] The aperture 114 can be defined to accommodate passage of one or more insertion needles and medical devices from a location within the device housing 102 to a location at least partially outside of the device housing 102. In examples, the aperture 114 is configured (e.g., shaped, sized, and / or positioned) to accommodate passage of a first insertion needle and a first medical device (e.g., a fluid delivery cannula), and to accommodate passage of a second insertion needle and a second medical device (e.g., an analyte sensor). The aperture 114 can be configured to accommodate passage of the needles and medical devices from a location within the device housing 102 to a location at least partially outside of the device housing 102. The aperture 114 can be configured to accommodate retraction of the first insertion needle and the second insertion needle from a location outside of the device housing 102 to a location within the device housing 102. In examples, the aperture 114 is configured to accommodate substantially simultaneous passage of the first insertion needle, the first medical device, the second insertion needle, and the second medical device. Thus, the aperture 114 can designate an insertion site on the user when the device housing 102 is positioned in close proximity to the user, and the first and second medical devices can share the insertion site in that they are each inserted via the insertion site.

[0044] Figure 3The therapy delivery device 100 is depicted in the form of a schematic. The therapy delivery device 100 is depicted in close proximity to (e.g., in contact with) the skin 118 of a user. The first medical device 120 is inserted into the user and extends through the aperture 114 from a location within the device housing 102 to a location outside of the device housing 102 (e.g., a first location under the skin 118). The second medical device 122 is inserted into the user and extends through the aperture 114 from another location within the device housing 102 to another location outside of the housing 102 (e.g., a second location under the skin 118). In an example, the first medical device 120 is a fluid delivery cannula configured to deliver a fluid (e.g., insulin) to the first location, and the second medical device 122 is an analyte sensor configured to sense a physiological property (e.g., a glucose level) at the second location. The insertion device 124 is configured to insert the first medical device 120 and the second medical device 122 into the user such that the first location and the second location are separated by a displacement D. Figure 3 An adhesive element 110 configured to substantially secure the device housing 102 to the skin of the user is also depicted.

[0045] The insertion device 124 can be configured to insert the first medical device 120 and the second medical device 122 into the user, for example, when the user actuates the insertion device 124 using the user input device 108. Accordingly, in some embodiments, the user input device 108 can be a component of the insertion device 124. For example, the user input device 108 can be a manually operated button on a housing 126 of the insertion device 124. The insertion device 124 can be configured to extend a first insertion needle (e.g., a first insertion needle 132 Figure 4 、 Figure 5A to Figure 5C ) through the aperture 114 to insert the first medical device 120 (e.g., a fluid delivery cannula) into the user, and / or to retract the first insertion needle through the aperture 114 when the first medical device 120 remains inserted into the user. The insertion device 124 can be configured to extend a second insertion needle (e.g., a second insertion needle 134 Figure 4 、 Figure 5A to Figure 5C ) through the aperture 114 to insert the second medical device 122 (e.g., an analyte sensor) into the user, and / or to retract the second insertion needle through the aperture 114 when the second medical device 122 remains inserted into the user. In some embodiments, the insertion device 124 can be a component of the therapy delivery device 100. In some other embodiments, the insertion device 124 can be separate from the therapy delivery device 100. For example, the insertion device 124 can include the housing 126 configured to couple with the device housing 102 during insertion and decouple from the device housing 102 upon completion of insertion.

[0046] The therapy delivery device 100 can also include a fluid infusion system 128 and a sensor system 130. The fluid infusion system 128 can be configured to deliver fluid (e.g., insulin) to a user. The sensor system 130 can be configured to monitor a physiological characteristic (e.g., glucose level) of a user.

[0047] Figure 4 is an example simplified block diagram representation of a therapy delivery device 100 including a device housing 102, a user input device 108, a first medical device 120, a second medical device 122, an insertion device 124 including a first insertion needle 132 and a second insertion needle 134, a fluid infusion system 128 including a fluid pump 136 and a pump motor 138, and a sensor system 130 including a sensor interface 173. The first insertion needle 132 can be configured to releasably engage the first medical device 120. The second insertion needle 134 can be configured to releasably engage the second medical device 122. The insertion device 124 is configured to move the first insertion needle 132 (e.g., generally along a path SI) to engage the first medical device 120 and to insert the first medical device 120 into a user. The insertion device 124 is configured to move the second insertion needle 134 (e.g., generally along a path S2) to insert the second medical device 120 into the user. The insertion device 124 can be configured to retract the first insertion needle 132 and the second insertion needle 134 to a position within the housing 102 while the first medical device 120 and the second medical device 122 remain inserted into the user.

[0048] The therapy delivery device 100 can be configured to provide fluid (e.g., insulin) to a user using, for example, the first medical device 120. The therapy delivery device 100 can be configured to provide fluid when the first medical device 120 is inserted into the user Figure 3 ). The therapy delivery device 100 can be configured to monitor a physiological characteristic (e.g., glucose level) of a user using, for example, the second medical device 122. The therapy delivery device 100 can be configured to monitor the physiological characteristic when the second medical device 122 is inserted into the user Figure 3 ). The insertion device 124 is configured to extend the first insertion needle 132 and the second insertion needle 134 away from the device housing 102 to insert the first medical device 120 and the second medical device 122, respectively, into a user and can be configured to retract the first insertion needle 132 and the second insertion needle 134 toward the housing 102 while the first medical device 120 and the second medical device 122 remain inserted. In an example, the first insertion needle 132 is configured to insert the first medical device 120 and the second insertion needle 134 is configured to insert the second medical device 122 via the aperture 114.

[0049] The insertion device 124 can be implemented in a variety of ways. InFigure 4 In the example of FIG. 1, the insertion device 124 includes a shaft 140 configured to rotate about a longitudinal rotational axis L ("axis L"). However, it should be appreciated that in some embodiments, the insertion device can be implemented without a shaft, and in some other embodiments, the insertion device can be implemented with multiple shafts.

[0050] In the example of FIG. 1, the insertion device 124 includes a shaft 140 configured to rotate about a longitudinal rotational axis L ("axis L"). However, it should be appreciated that in some embodiments, the insertion device can be implemented without a shaft, and in some other embodiments, the insertion device can be implemented with multiple shafts. Figure 4 In the example of FIG. 1, the insertion device 124 includes a shaft 140 configured to rotate about a longitudinal rotational axis L ("axis L"). However, it should be appreciated that in some embodiments, the insertion device can be implemented without a shaft, and in some other embodiments, the insertion device can be implemented with multiple shafts.

[0051] In the example of FIG. 1, the insertion device 124 includes a shaft 140 configured to rotate about a longitudinal rotational axis L ("axis L"). However, it should be appreciated that in some embodiments, the insertion device can be implemented without a shaft, and in some other embodiments, the insertion device can be implemented with multiple shafts.

[0052] In some embodiments, the insertion device 124 can be a component of the therapy delivery device 100. Accordingly, the insertion device 124 can be configured to move the first needle distal end 142 and the second needle distal end 144 from a position within the housing 102 to a position outside of the housing 102 when the shaft 140 is rotated in the first rotational direction Rl, and can be configured to move the first needle distal end 142 and the second needle distal end 144 from a position outside of the housing 102 to a position inside of the housing 102 when the shaft 140 is rotated in the second rotational direction R2. The first insertion needle 132 and the second insertion needle 134 can be configured to insert the first medical device 120 and the second medical device 122, respectively, into a user when the first insertion needle 132 and the second insertion needle 134 extend outside of the housing 102, and / or configured to release the first medical device 120 and the second medical device 122, respectively, when the first insertion needle 132 and the second insertion needle 134 are retracted inside of the housing 102, such that the first medical device 120 (e.g., a fluid delivery cannula) and the second medical device 122 (e.g., an analyte sensor) remain inserted in the user. In an example, the first insertion needle 132 and the second insertion needle substantially simultaneously insert the first medical device 120 and the second medical device 122.

[0053] In some other embodiments, the insertion device 124 can be external to the therapy delivery device 100. As will be described in greater detail below, the insertion device 124 can include a housing 126 configured to couple with the housing 102 to insert the medical devices 120 and 122 into the patient.

[0054] The insertion device 124 can be configured to cause the first needle distal end 142 to travel substantially along the first path SI as the insertion device 124 extends and / or retracts the first insertion needle 132. The insertion device 124 can be configured to cause the second needle distal end 144 to travel substantially along the second path S2 as the insertion device 124 extends and / or retracts the second insertion needle 134. In an example, the insertion device 124 is configured such that the first path SI and the second path S2 cause the first needle distal end 142 and the second needle distal end 144 to gradually move away from each other as the first needle distal end 142 and / or the second needle distal end 144 move in a direction away from the housing 102. In an example, the insertion mechanism unit 124 is configured such that one of the first path SI or the second path S2 defines a first curvature about the axis L, and such that the other of the first path SI or the second path S2 defines a second curvature about the axis L. In some embodiments, the second curvature can be less than the first curvature. For example, the insertion device 124 can be configured such that the first path SI is substantially circular and the second path S2 is substantially linear. In some embodiments, the first curvature and the second curvature can have opposite orientations. For example, the first curvature can be clockwise and the second curvature can be counterclockwise. The insertion device 124 can define the first path SI and the second path S2 so as to generate a displacement D between the first medical device 120 and the second medical device 122 within the user’s body 101. Figure 3 ).

[0055] The insertion device 124 can be configured to cause the first needle distal end 142 and the second needle distal end 144 to pass through the aperture 114 as the first needle distal end 142 and the second needle distal end 144 transition to a location within the patient. In an example, the insertion device 124 is configured to cause the first needle distal end 142 and the second needle distal end 144 to pass through the patient’s skin 118 Figure 2The insertion region 149 can be a relatively small region on the patient's skin such that the patient perceives a single puncturing action from penetration of both the first insertion needle 132 and the second insertion needle 134. In some examples, the insertion device 124 is configured to insert the first insertion needle 132 and the second insertion needle 134 through the patient's skin through substantially the same puncture site on the patient's skin. For example, one of the first insertion needle 132 or the second insertion needle 134 can be configured to initially puncture and insert through the skin at the puncture site, and the other of the first insertion needle 132 or the second insertion needle 134 can be configured to insert through the skin through substantially the same puncture site.

[0056] The insertion device 124 also includes a driver 150 configured to rotate the shaft 140 in the first rotational direction Rl and / or the second rotational direction R2. In examples, the driver 150 is configured to initially rotate the shaft 140 in the first rotational direction Rl and subsequently rotate the shaft 140 in the second rotational direction R2 (e.g., resulting in initial extension of the insertion needles 132, 134 followed by subsequent retraction of the insertion needles 132, 134). For example, the driver 150 can be configured to initially move the first needle distal end 142 and / or the second needle distal end 144 from a position within the housing 102 to a position outside of the housing 102 (e.g., by initially rotating the shaft 140 in the first rotational direction Rl) and configured to subsequently move the first needle distal end 142 and / or the second needle distal end 144 from the position outside of the housing 102 to the position within the housing 102 (e.g., by subsequently rotating the shaft 140 in the second rotational direction R2). In examples, the user input device 108 is configured to rotate the shaft 140 in the first rotational direction Rl and / or the second rotational direction R2 by the driver 150 such that a user can control implantation of the first medical device 120 and the second medical device 122. In some examples, as will be discussed, the driver 150 can include one or more springs configured to rotate the shaft 140 about the axis L. In some examples, the driver 150 includes a first spring configured to rotate the shaft 140 in the first rotational direction Rl and a second spring configured to rotate the shaft 140 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 rotate the shaft 140 about the axis L.

[0057] In an example, the therapy delivery device 100 includes a first conduit 156 that defines a first flow path 152 from a discharge 153 of the fluid pump 136 to the first medical device 120. In an example, the first medical device 120 is a fluid delivery cannula that defines a lumen 154, and the first conduit 156 is configured to define the first flow path 152 from the discharge 153 of the fluid pump 136 through the lumen 154 of the fluid delivery cannula. The therapy delivery device 100 can be configured to house a fluid reservoir 158 (e.g., within the device housing 102 and / or the fluid cartridge 104 Figure 1 , 2 )) In an example, the therapy delivery device 100 includes a second conduit 162 that is configured to define a second flow path 160 from the reservoir 158 to a suction inlet 161 of the fluid pump 136. The fluid pump 136 can include a motor 138 that is configured to cause the fluid pump 136 to create pressure to deliver fluid (e.g., via the first flow path 152). The fluid infusion system 128 can include one or more of the fluid pump 136, the motor 138, the first conduit 156, the fluid reservoir 163, and / or the second conduit 162.

[0058] The therapy delivery device 100 can include one or more of a processor device 166; one or more memory elements 168 to store and / or maintain data, processor-readable program instructions; one or more batteries 170 or other power sources; and / or a sensor interface 173 that is configured to establish electrical connectivity with a medical device, such as the second medical device 122. The processor device 166, the memory elements 168, the battery 170, and / or the sensor interface 173 can be included on an electronics assembly 171 (e.g., a printed circuit board). In an example, the second medical device 122 is an analyte sensor that is configured to electrically connect to the sensor interface 173 (e.g., via a wire) to establish electrical connectivity between conductors of the analyte sensor and conductors of the electronics assembly 171. The electronics assembly 171 (or components of the electronics assembly 171) can be electrically connected to other elements of the therapy delivery device 100 as needed to support operation of the therapy delivery device 100. For example, the electronics assembly 171 can be electrically connected to at least, but not limited to: the fluid pump 136; the sensor interface 173; the insertion device 124; and the user input device 108. It should be understood that electrical connections to the electronics assembly 171 can be direct or indirect, as needed. Further, in some embodiments, one or more components of the electronics assembly 171 can support wireless data communication.

[0059] In an example, the processor device 166 includes processing circuitry configured to control operation of the fluid pump 136. For example, the processing circuitry can be configured to cause the fluid pump 136 to start, continue, and / or stop transport of fluid from the fluid reservoir 158 to the first medical device 120 (e.g., a fluid delivery cannula).

[0060] In an example, the first medical device 120 and / or the second medical device 122 is an analyte sensor configured to generate a signal indicative of a physiological characteristic (e.g., a glucose level) of a user, 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 operation of the fluid pump 136 based on the indicative signal reported by the analyte sensor. The analyte sensor can be coupled to the sensor system 130. The sensor system 130 can also include a sensor interface 173 and a lead for connecting the analyte sensor to the sensor interface 173.

[0061] The device housing 102 can be suitably shaped, sized, and configured to house or support the electronic assembly 171, the fluid pump 136, the fluid reservoir 158, the sensor interface 173, and / or the user input device 108. Figure 3 The fluid infusion system 128 depicted in Figure 4 The fluid pump 136, the fluid reservoir 158, the first conduit 156, and the second conduit 162 shown. Figure 3 The sensor system 130 depicted in Figure 4 The sensor interface 173 shown.

[0062] Figure 5A 、 Figure 5B and Figure 5C Interactions between a portion of the therapy delivery device 100 and the insertion device 124 are schematically illustrated. The insertion device 124 can include a shaft 140 configured to extend and / or retract the first insertion needle 132 through the aperture 114 in the housing 102 and configured to extend and / or retract the second insertion needle 134 through the aperture 114 in the housing 102. An axis line L is included for reference. The driver 150 can be configured to rotate the shaft 140 in a first rotational direction Rl to cause the insertion device 124 to transition from a Figure 5A to a Figure 5B to extend the insertion needles 132, 134 through the aperture 114 in the housing 102. The driver 150 can be configured to rotate the shaft 140 in a second rotational direction R2 to cause the insertion device 124 to transition from a Figure 5B to a Figure 5CThe first and second insertion needles 132 and 134 are configured to retract through the hole 114 in the housing 102. The first insertion needle 132 and the second insertion needle 134 can be configured to release the first medical device 120 and the second medical device 122 respectively, such that the first medical device 120 and the second medical device 122 remain inserted into the user's body when the insertion needles 132 and 134 are retracted by the insertion device 124. In the example, the actuator 150 includes a first spring 172 configured to rotate the shaft 140 in a first rotational direction R1; and a second spring 174 configured to rotate the shaft 140 in a second rotational direction R2.

[0063] Shaft 140 can be configured to drive first insertion needle 132 such that its distal end 142 is inserted through the user's skin when shaft 140 rotates about axis L in a first rotational direction R1. First insertion needle 132 can be configured such that movement of the distal end 142 defines a curved path S1 about axis L as shaft 140 drives the first insertion needle 132 through the user's skin. In the example, the first insertion needle 132 is a curved needle that is substantially curved about axis L. First insertion needle 132 can be configured such that when shaft 140 drives the first insertion needle 132 through the skin, the distal end 142 substantially passes through the user's tissue in a curved path (e.g., path S1) relative to axis L. In the example, when shaft 140 rotates about axis L in the first rotational direction R1, insertion device 124 causes the first insertion needle 132 to rotate about axis L in the first rotational direction R1. In the example, insertion device 124 is configured to engage the first insertion needle 132 with the first medical device 120 when shaft 140 rotates in the first rotational direction R1. For example, the first insertion needle 132 may taper toward the distal end 142 such that rotation of the shaft 140 causes the needle 132 to be inserted through the cavity 154 until the first medical device 120 contacts the needle 132. As will be discussed, the first insertion needle 132 may be configured to engage the first medical device 120 such that at least a portion of the first medical device 120 is displaced from a position within the housing 102 (e.g., as...). Figure 5A The position of the first conduit 156 depicted in the diagram) is shifted to a position outside the housing 102 (e.g., as shown in the diagram). Figure 5B (As shown).

[0064] Shaft 140 can be configured to apply torque about axis L to insert pins (e.g., first insert pin 132 and / or second insert pin 134) that bend about axis L. For example, in Figure 5A to Figure 5CIn particular embodiments, the shaft 140 is configured to apply a torque about the axis L to the first insertion needle 132 that is curved about the axis L. The shaft 140 can apply the torque such that the first insertion needle 132 is caused to rotate substantially about the axis L when the shaft 140 is rotated about the axis L. In examples, the shaft 140 is mechanically connected to the first insertion needle 132 to apply the torque. For example, the shaft 140 can be mechanically connected to the first insertion needle by struts 178 that extend between the shaft 140 and the first insertion needle 132, although this is not required. The shaft 140 can apply the torque about the axis L to the first insertion needle 132 in any manner. In some examples, a surface of the shaft 140 is configured to frictionally engage a surface of the first insertion needle 132 such that the frictional engagement causes the shaft 140 to apply the torque to the first insertion needle 132. In some examples, the shaft 140 can be configured to rotate a pinion gear that is in meshing engagement with a curved rack gear that is coupled to the first insertion needle 132 such that the meshing engagement causes the shaft 140 to apply the torque to the first insertion needle 132.

[0065] The shaft 140 can also be configured to drive the second insertion needle 134 to insert the second needle distal end 144 through the user’s skin when the shaft 140 is rotated about the axis L in the first rotational direction Rl. In examples, the second insertion needle 134 is a substantially straight needle that is configured to exhibit linear motion relative to the housing 102 when the shaft 140 is rotated about the axis L. The second insertion needle 134 can be configured such that movement of the second needle distal end 144 defines a path S2 when the shaft 140 drives the second insertion needle 134 to insert through the user’s skin. In examples, the path S2 has a different curvature (e.g., a reduced curvature) relative to the axis L as compared to the path SI. In some examples, the path S2 is a substantially linear path. The second insertion needle 134 can be configured such that the second needle distal end 144 passes through the user’s tissue substantially along the path S2 when the shaft 140 drives the second insertion needle 134 through the skin. The second insertion needle 134 can be configured to engage the second medical device 122 to displace at least a portion of the second medical device 122 from a position within the housing 102 (e.g., as depicted in FIG. 1) to a position outside of the housing 102 (e.g., as shown in FIG. 2). For example, the second insertion needle 134 can have a hollow portion toward the distal end 144 and can define an opening in the distal end 144 such that rotation of the shaft 140 causes the needle 134 to house the second medical device 122 within the hollow portion. Figure 5A The second insertion needle 134 can be configured to engage the second medical device 122 to displace at least a portion of the second medical device 122 from a position within the housing 102 (e.g., as depicted in FIG. 1) to a position outside of the housing 102 (e.g., as shown in FIG. 2). For example, the second insertion needle 134 can have a hollow portion toward the distal end 144 and can define an opening in the distal end 144 such that rotation of the shaft 140 causes the needle 134 to house the second medical device 122 within the hollow portion. Figure 5B The second insertion needle 134 can be configured to engage the second medical device 122 to displace at least a portion of the second medical device 122 from a position within the housing 102 (e.g., as depicted in FIG. 1) to a position outside of the housing 102 (e.g., as shown in FIG. 2). For example, the second insertion needle 134 can have a hollow portion toward the distal end 144 and can define an opening in the distal end 144 such that rotation of the shaft 140 causes the needle 134 to house the second medical device 122 within the hollow portion.

[0066] In examples, the shaft 140 is configured to apply a substantially linear force to an insertion needle (e.g., the first insertion needle 132 and / or the second insertion needle 134). For example, in examples, the shaft 140 is configured to apply a substantially linear force to the first insertion needle 132 to cause the first insertion needle 132 to rotate substantially about the axis L when the shaft 140 is rotated about the axis L. In examples, the shaft 140 is configured to apply a substantially linear force to the second insertion needle 134 to cause the second insertion needle 134 to move linearly relative to the housing 102 when the shaft 140 is rotated about the axis L. Figure 5A to Figure 5CIn this configuration, shaft 140 is configured to apply a substantially linear force to the second insertion pin 134, causing the distal end of the second pin 144 to travel along path S2. Shaft 140 can apply a substantially linear force when rotated about axis L. In this example, shaft 140 is operatively connected to the second insertion pin 134 to apply a substantially linear force. In some examples, shaft 140 is configured to cause interaction with a rack and pinion coupled to the second insertion pin (e.g., rack and pinion 182). Figure 6 The meshing pinions (e.g., pinion 180) Figure 6 The rotation of shaft 140 134 is possible, but not necessary. Shaft 140 can apply a substantially linear force to the second insertion pin 134 in any manner, including mechanisms configured to convert the rotational torque of shaft 140 into a substantially linear force on the second insertion pin 134. In some examples, the surface of shaft 140 is configured to frictionally engage the surface of the second insertion pin 134, such that the frictional engagement causes shaft 140 to apply a substantially linear force to the second insertion pin 134.

[0067] Figure 6 An example of an insertion device 124 including a driver 150 is schematically shown. Figure 6 In the example, the actuator 150 includes a first spring 172 configured to rotate the shaft 140 relative to the housing 102 in a first rotational direction R1. The first spring 172 can be configured to convert potential energy into kinetic energy to cause rotation. For example, the first spring 172 may be in a load state storing potential energy (e.g., wound or loaded) and may convert a portion of the potential energy into kinetic energy (e.g., by fully or partially unfolding or unloading) to cause the shaft 140 to rotate in the first rotational direction R1. The insertion device 124 can be configured such that fully or partially unfolding or unloading the first spring 172 causes the insertion device 124 to... Figure 5A The form of transformation to Figure 5B The first spring 172 is a torsion spring configured to rotate about an axis L in a first rotational direction R1 when the first spring 172 converts potential energy into kinetic energy. The first spring 172 may be mechanically engaged with a shaft 140 such that rotation of the first spring 172 about the axis L in the first rotational direction R1 causes rotation of the shaft 140 in the first rotational direction R1. In the example, the first spring 172 includes a helical coil 184 (“first helical coil 184”) which is about the axis L and configured to rotate about the axis L. In the example, the first helical coil 184 is about the shaft 140. The shaft 140 may be mechanically engaged with the first spring 172 (e.g., the first helical coil 184) such that when the first spring 172 rotates about the axis L, the spring 172 applies a first torque about the axis L to the shaft 140.

[0068] In an example, the first spring 172 is a torsion spring having a primary end 186 ("first spring primary end 186") and a secondary end 188 ("first spring secondary end 188"). The torsion spring can be configured to store potential energy by substantially winding around a spring axis (e.g., twisting about) and can be configured to cause movement of the first spring primary end 186 relative to the first spring secondary end 188 when the torsion spring unwinds to dissipate the potential energy. The spring axis can be substantially parallel to and / or coincident with the axis L. The first spring 172 can be configured to exert a first torque on the shaft 140 when the first spring primary end 186 moves relative to the first spring secondary end 188. In an example, the first spring 172 is configured to cause the first spring primary end 186 to move in a rotational direction R3 about the axis L relative to the first spring secondary end 188 when the first spring 172 dissipates potential energy. The rotational direction R3 can be similar to or substantially the same as the first rotational direction Rl. In some examples, the first spring secondary end 188 is coupled to a support structure 191 that is configured to be substantially stationary relative to the housing 102 such that movement of the first spring primary end 186 relative to the support structure 191 causes relative movement between the first spring primary end 186 and the first spring secondary end 188.

[0069] In an example, the insertion device 124 includes a release mechanism unit that is configured to substantially maintain the position of the first spring primary end 186 relative to the first spring secondary end 188 such that the first spring 172 is constrained from exerting a torque on the shaft 140 until the user input device 108 is actuated Figure 1 、 Figure 3 、 Figure 4 ). When the user input device 108 is actuated, the insertion device 124 can be configured to allow the first spring primary end 186 to move relative to the first spring secondary end 188 such that the first spring 172 (e.g., the first helical coil 184) exerts a torque on the shaft 140, thereby causing the shaft 140 to rotate about the axis L in the first rotational direction Rl. For example, the insertion device 100 can include a mechanical stop 190 that is configured to mechanically engage the first spring 172 (e.g., the first spring primary end 186) to constrain movement of the first spring primary end 186 relative to the first spring secondary end 188 such that the first spring 172 is substantially prevented from exerting a torque on the shaft 140. The mechanical stop 190 can be configured to mechanically disengage from the spring 172 (e.g., the first spring primary end 186) such that the spring 172 is free to move the first spring primary end 186 relative to the first spring secondary end 188 in the rotational direction R3 and such that the first spring 172 exerts a torque on the shaft 140 in the first rotational direction Rl.

[0070] In some examples, instead of or in addition to the mechanical stop 190, the insertion device 124 can include a mechanical stop 192 configured to substantially prevent rotation of the shaft 140 in the first rotational direction Rl such that the shaft 140 resists the torque applied by the first spring 172. The mechanical stop 192 can be configured to be mechanically disengaged from the shaft 140 such that rotation of the shaft 140 by the torque applied by the spring 172. In examples, the mechanical stop 190 and / or 192 is configured to establish a first position in which the spring 172 is constrained from causing rotation of the shaft 140 and is configured to establish a second position in which the spring 172 is not constrained from causing rotation of the shaft 140. The user input device 108 can be configured to transition the mechanical stop 190 and / or 192 from the first position to the second position. The user input device 108 can be coupled to the mechanical stop 190, 192 wirelessly, electrically, mechanically, or in any other effective manner.

[0071] The driver 150, including the first spring 172 and / or the second spring 174, is one example of a driver configured to cause rotation of the shaft 140. The driver 150 can cause rotation of the shaft 140 in any manner. In examples, the driver 150 includes one or more motors configured to cause rotation of the shaft 140. The one or more motors can be, for example, rotary motors configured to use rotation of an output shaft to cause rotation, linear motors configured to use translation of a slider to cause rotation, or other types of motors configured to produce an output motion (e.g., relative to a motor housing) and use the output motion to cause rotation. The one or more motors can be constant speed or variable speed motors, and can be configured to rotate the shaft 140 at a constant rotational speed or a varying rotational speed. In examples, the one or more motors are configured to receive power from a battery (e.g., the battery 170 within the therapy delivery device 100). The insertion device 124 and / or the therapy delivery device 100 can include processing circuitry configured to control the one or more motors (e.g., configured to cause the motor to generate motion, stop generating motion, generate motion at a particular speed, etc.). In examples, the user input device 108 is configured to actuate the one or more motors to cause rotation of the shaft 140.

[0072] Figure 5B The driver 150 is shown to have caused rotation of the shaft 140 in the first rotational direction Rl. In Figure 5B The rotation of the shaft 140 in the first rotational direction Rl has caused the first insertion needle 132 and the second insertion needle 134 to extend from the housing 102 such that the first needle distal end 142 and the second needle distal end 144 reach a position outside of the housing 102, further in Figure 5BIn particular, rotation of the shaft 140 in the first rotational direction Rl has caused the first insertion needle 132 to displace the first medical device 120 from an initial position in which the first medical device 120 is within the housing 102 (e.g., within the housing 102 and / or within the needle 130) to an at least partially implanted position in which at least some portion of the first medical device 120 is outside of the housing 102. Figure 5A In particular, rotation of the shaft 140 in the first rotational direction Rl has caused the first insertion needle 132 to displace the first medical device 120 from an initial position in which the first medical device 120 is within the housing 102 (e.g., within the housing 102 and / or within the needle 130) to an at least partially implanted position in which at least some portion of the first medical device 120 is outside of the housing 102. Figure 5B In particular, rotation of the shaft 140 in the first rotational direction Rl has caused the first insertion needle 132 to displace the first medical device 120 from an initial position in which the first medical device 120 is within the housing 102 (e.g., within the housing 102 and / or within the needle 130) to an at least partially implanted position in which at least some portion of the first medical device 120 is outside of the housing 102. Figure 5A In particular, rotation of the shaft 140 in the first rotational direction Rl has caused the first insertion needle 132 to displace the first medical device 120 from an initial position in which the first medical device 120 is within the housing 102 (e.g., within the housing 102 and / or within the needle 130) to an at least partially implanted position in which at least some portion of the first medical device 120 is outside of the housing 102.

[0073] In particular, rotation of the shaft 140 in the first rotational direction Rl has caused the first insertion needle 132 to displace the first medical device 120 from an initial position in which the first medical device 120 is within the housing 102 (e.g., within the housing 102 and / or within the needle 130) to an at least partially implanted position in which at least some portion of the first medical device 120 is outside of the housing 102. Figure 5B In particular, rotation of the shaft 140 in the first rotational direction Rl has caused the first insertion needle 132 to displace the first medical device 120 from an initial position in which the first medical device 120 is within the housing 102 (e.g., within the housing 102 and / or within the needle 130) to an at least partially implanted position in which at least some portion of the first medical device 120 is outside of the housing 102. Figure 5C In particular, rotation of the shaft 140 in the first rotational direction Rl has caused the first insertion needle 132 to displace the first medical device 120 from an initial position in which the first medical device 120 is within the housing 102 (e.g., within the housing 102 and / or within the needle 130) to an at least partially implanted position in which at least some portion of the first medical device 120 is outside of the housing 102.

[0074] In particular, rotation of the shaft 140 in the first rotational direction Rl has caused the first insertion needle 132 to displace the first medical device 120 from an initial position in which the first medical device 120 is within the housing 102 (e.g., within the housing 102 and / or within the needle 130) to an at least partially implanted position in which at least some portion of the first medical device 120 is outside of the housing 102. Figure 5A to Figure 5C In particular, rotation of the shaft 140 in the first rotational direction Rl has caused the first insertion needle 132 to displace the first medical device 120 from an initial position in which the first medical device 120 is within the housing 102 (e.g., within the housing 102 and / or within the needle 130) to an at least partially implanted position in which at least some portion of the first medical device 120 is outside of the housing 102. Figure 6 In particular, rotation of the shaft 140 in the first rotational direction Rl has caused the first insertion needle 132 to displace the first medical device 120 from an initial position in which the first medical device 120 is within the housing 102 (e.g., within the housing 102 and / or within the needle 130) to an at least partially implanted position in which at least some portion of the first medical device 120 is outside of the housing 102. Figure 5B In particular, rotation of the shaft 140 in the first rotational direction Rl has caused the first insertion needle 132 to displace the first medical device 120 from an initial position in which the first medical device 120 is within the housing 102 (e.g., within the housing 102 and / or within the needle 130) to an at least partially implanted position in which at least some portion of the first medical device 120 is outside of the housing 102. Figure 5CIn examples, the second spring 174 is a torsion spring having a primary end 196 ("second spring primary end 196") and a secondary end 198 ("second spring secondary end 198"). The torsion spring can be configured to store potential energy by substantially winding around (e.g., twisting around) a spring axis of the second spring 174, and can be configured to cause movement of the second spring primary end 196 relative to the second spring secondary end 198 when the torsion spring unwinds to dissipate the potential energy. The spring axis of the second spring 174 can be substantially parallel to and / or coincident with the axis L. The second spring 174 can be configured to exert a second torque on the shaft 140 when the second spring primary end 196 moves relative to the second spring secondary end 198. In examples, the second spring 174 is configured to cause the second spring primary end 196 to move in a rotational direction R4 around the axis L relative to the second spring secondary end 198 when the second spring 174 dissipates potential energy. The rotational direction R4 can be similar to or substantially the same as the second rotational direction R2.

[0075] In examples, the second spring 174 is a torsion spring having a primary end 196 ("second spring primary end 196") and a secondary end 198 ("second spring secondary end 198"). The torsion spring can be configured to store potential energy by substantially winding around (e.g., twisting around) a spring axis of the second spring 174, and can be configured to cause movement of the second spring primary end 196 relative to the second spring secondary end 198 when the torsion spring unwinds to dissipate the potential energy. The spring axis of the second spring 174 can be substantially parallel to and / or coincident with the axis L. The second spring 174 can be configured to exert a second torque on the shaft 140 when the second spring primary end 196 moves relative to the second spring secondary end 198. In examples, the second spring 174 is configured to cause the second spring primary end 196 to move in a rotational direction R4 around the axis L relative to the second spring secondary end 198 when the second spring 174 dissipates potential energy. The rotational direction R4 can be similar to or substantially the same as the second rotational direction R2.

[0076] In examples, the insertion device 124 is configured to substantially prevent movement of the second spring primary end 196 relative to the second spring secondary end 198 when the shaft 140 is rotated in the first rotational direction, such that the second spring 174 enters and / or remains in the wound state. In other words, the insertion device 124 can be configured to substantially prevent movement of the second spring primary end 196 relative to the second spring secondary end 198 when the first spring 172 unwinds to rotate the shaft 140.

[0077] For example, Figure 7A , Figure 7B and Figure 7CAn example driver 150 is shown that includes a first spring 172 and a second spring 174. The first spring 172 includes a first spring primary end 186 and a first spring secondary end 188. A first helical coil 184 is around the shaft 140 and mechanically joined to the shaft 140 by a fixation structure 202 (“first fixation structure 202”) such that rotation of the first helical coil 184 around the axis L causes rotation of the shaft 140 around the axis L. The second spring 174 includes a second spring primary end 196 and a second spring secondary end 198. A second helical coil 194 is around the shaft 140 and mechanically joined to the shaft 140 by a fixation structure 204 (“second fixation structure 204”) such that rotation of the second helical coil 194 around the axis L causes rotation of the shaft 140 around the axis L. The first spring 172 is configured to cause the shaft 140 to rotate in a first rotational direction R1 when the first spring primary end 186 moves relative to the first spring secondary end 188. The second spring 174 is configured to cause the shaft 140 to rotate in a second rotational direction R2 when the second spring primary end 196 moves relative to the second spring secondary end 198. The shaft 140 is configured to rotate around the axis L. The shaft 140, the first fixation structure 202, and the second fixation structure 204 are shown in cross-section with a cut plane that is parallel to the page.

[0078] Figure 7A The first spring 172 is shown with a support structure 191 engaged (e.g., mechanically engaged) with the first spring secondary end 188 to substantially limit movement of the first spring secondary end 188 relative to the housing 102. The mechanical stop 190 is in a first position PI to engage (e.g., mechanically engage) the first spring primary end 186 such that the mechanical stop 190 substantially prevents movement of the first spring primary end 186 relative to the first spring secondary end 188 in the first position P. A mechanical stop 206 is engaged (e.g., mechanically engaged) with the second spring primary end 196 and a mechanical stop 208 is engaged (e.g., mechanically engaged) with the second spring secondary end 198. The mechanical stops 206, 208 substantially prevent movement of the second spring primary end 196 relative to the second spring secondary end 198.

[0079] Figure 7B The mechanical stop 190 is shown having been repositioned from the first position PI to a second position P2. In the second position P2, the mechanical stop 190 is disengaged from the first spring 172 (e.g., the first spring primary end 186) such that potential energy of the first spring 172 can cause the first spring primary end 186 to move relative to the first spring secondary end 188. Figure 7BThe first spring primary end 186 is shown having moved about the shaft 140 in the first rotational direction Rl relative to the first spring secondary end 188. The movement of the first spring primary end 186 has caused the first spring 172 to exert a first torque on the shaft 140, causing the shaft 140 to rotate in the first rotational direction Rl. The mechanical stop 206, 208 is configured to rotate about the axis L in the first rotational direction Rl as the shaft 140 rotates in the first rotational direction Rl, such that the mechanical stop 206, 208 substantially prevents the second spring 174 from unwinding to dissipate potential energy as the shaft 140 rotates in the first rotational direction Rl. In Figure 7B the first position P3 to engage the second spring 174 (e.g., the second spring primary end 196) and substantially prevent movement of the first spring primary end 186 relative to the first spring secondary end 188.

[0080] Figure 7C The mechanical stop 190 is shown having been repositioned from the first position P3 to a second position P4. In the second position P4, the mechanical stop 206 is disengaged from the second spring 174 (e.g., the second spring primary end 196), such that potential energy of the second spring 174 can cause the second spring primary end 196 to move relative to the second spring secondary end 198. Figure 7C The second spring primary end 196 is shown having moved about the shaft 140 in the second rotational direction R2 relative to the second spring secondary end 188. The movement of the second spring primary end 196 has caused the second spring 174 to exert a second torque on the shaft 140, causing the shaft 140 to rotate in the second rotational direction R2.

[0081] The driver 150 can be configured to cause the shaft 140 to rotate in the first rotational direction Rl (e.g., to cause extension of the insertion needles 132, 134 Figure 4 、 Figure 5A to Figure 5C 、 Figure 6The actuator 150 is configured to rotate shaft 140 in a second rotational direction R2 (e.g., to cause retraction of insertion pins 132, 134). In the example, the actuator 150 is configured to cause rotation in the second rotational direction R2 after shaft 140 has rotated a certain amount in the first rotational direction R1. For example, the actuator 150 may include a limit switch 210 configured to cause a second torque to be applied to shaft 140 by a second spring 174 when shaft 140 has rotated a certain amount. In the example, the limit switch 210 is configured to change mechanical stop 206 from a first position P3 to a second position P4 when shaft 140 has rotated a certain amount. The limit switch 210 may be, for example, a mechanical switch configured to be actuated by the second spring 174 (e.g., the secondary end 198 of the second spring) and / or a portion of shaft 140 when shaft 140 has rotated a certain amount. In other examples, the limit switch 210 may be a proximity switch, such as a magnetic switch configured to be activated by the second spring 174 and / or shaft 140 approaching the limit switch 210. In some examples, the limit switch 210 may be a position sensor configured to sense the position of the second spring 174 and / or shaft 140.

[0082] The second spring 174 can be configured to cause the shaft 140, and thus the first spring 172, to rotate in the second rotational direction R2. The insertion device 124 can be configured such that the first spring 172 substantially winds back (e.g., stores potential energy) when the shaft 140 rotates in the second rotational direction R2. In an example, the second spring 174 is configured to cause the first spring 172 to store potential energy when the second spring 174 causes the shaft 140 to rotate in the second rotational direction. In some examples, the first spring 172 has a first torsion ratio over a certain amount of rotation of the shaft 140, and the second spring 174 has a second torsion ratio over a certain amount of rotation of the shaft 140, and the second torsion ratio of the second spring 174 is greater than the first torsion ratio of the first spring 172.

[0083] User input device 108 Figure 1 , Figure 3 , Figure 4 The driver 150 can be configured to reposition the mechanical stop 190 from a first position P1 to a second position P2, causing the driver 150 to extend the insertion pins 132, 134. The user input device 108 can be configured to reposition the mechanical stop 206 from a first position P3 to a second position P4, causing the driver 150 to retract the insertion pins 132, 134. In the example, the user input device 108 can be configured to reposition the mechanical stop 190 from a first position P1 to a second position P2, causing the driver 150 to extend and / or retract the insertion pins 132, 134. Furthermore, although... Figure 7A to Figure 7CThe diagram shows a rotation of approximately 180 degrees in a first rotational direction R1 and a second rotational direction R2. The driver 150 can be configured to rotate the shaft 140 by any amount in the first rotational direction R1 and / or the second rotational direction. The user input device 108 can be wirelessly, electrically, mechanically, or in any other effective manner connected to the mechanical stops 190, 206.

[0084] The actuator 150 can use any elastic object configured to store mechanical energy as potential energy and configured to use the dissipation of potential energy to cause rotation of the shaft 140. Springs 172 and 174 can be any type of spring. For example, springs 172 and 174 can be torsion springs, compression springs, leaf springs, helical springs, flat springs, machined springs, serpentine springs, sock springs, or another type of spring configured to store potential energy. Springs 172 and 174 can be constant-force or variable-force springs. The actuator 150 can use any number and type of springs in any combination to cause rotation of the shaft 140.

[0085] Therefore, the insertion device 124 can be configured to extend the insertion pins 132, 134 away from the housing 102 and / or subsequently retract them in a direction toward the housing 102 when the shaft 140 rotates relative to the housing 102. In the example, the insertion device 124 is configured to cause the first insertion pin 132 to extend from a first undeployed position within the housing 102, wherein the distal end 142 of the first pin is in a first undeployed position. Figure 5A ) transform (e.g., along path S1) to a first unfolded position in which the distal end 142 of the first needle is outside the housing 102 ( Figure 5B In the example, the insertion device 124 is configured to allow the second insertion pin 134 to emerge from a second undeployed position within the housing 102, where the distal end 144 of the second pin is located. Figure 5A ) transform (e.g., along path S2) to a second unfolded position where the distal end 144 of the second needle is outside the housing ( Figure 5B The insertion device 124 can be configured to change the first insertion pin 132 from a first extended position to a first retracted position. Figure 5C The distal end 142 of the first needle is within the housing 102. The insertion device 124 can be configured to change the second insertion needle 134 from a second extended position to a second retracted position. Figure 5C The distal end 144 of the second needle is inside the housing 102. The first retracted position may be a position different from the first undeployed position, or a position substantially the same as the first undeployed position, and the second retracted position may be a position different from the second undeployed position, or a position substantially the same as the second undeployed position.

[0086] The insertion device 124 can be configured and / or supported within the housing 102 to cause extension and / or retraction of the first insertion needle 132 in any direction relative to the housing 102. The insertion device 124 can be configured and / or supported within the housing 102 to cause extension and / or retraction of the second insertion needle 134 in any direction relative to the housing 102. Further, the shaft 140, the first insertion needle 132, the second insertion needle 134, the first spring 172, the second spring 174, and / or other components of the insertion device 124 can have any orientation relative to the housing 102 and to each other sufficient to cause extension and / or retraction of the first insertion needle 132 and the second insertion needle 134. The insertion device 124 can be configured to cause extension and / or retraction of the first insertion needle 132 and the second insertion needle 134, and at least partial implantation of the first medical device 120 and the second medical device 122 at any angle relative to the housing 102. The insertion device 124 can be configured to cause extension and / or retraction of the first insertion needle 132 and the second insertion needle 134, and at least partial implantation of the first medical device 120 and the second medical device 122 at any angle relative to the patient when the insertion device 124 is in close proximity to the patient's skin 118.

[0087] The insertion device 124 can be configured to cause the first insertion needle 132 to be inserted substantially simultaneously with the second insertion needle 134 and / or configured to cause the first insertion needle 132 to be inserted sequentially (e.g., before or after) relative to the insertion of the second insertion needle 134. The insertion device 124 can be configured to cause the first insertion needle 132 to be retracted substantially simultaneously with the second insertion needle 134 and / or configured to cause the first insertion needle 132 to be retracted sequentially (e.g., before or after) relative to the retraction of the second insertion needle 134.

[0088] As discussed, the first insertion needle 132 can be configured to releasably engage the first medical device 120 to cause at least partial implantation of the first medical device 120 into the patient. In examples, the first medical device 120 is a fluid delivery cannula configured to deliver a fluid (e.g., insulin) to a user. The first insertion needle 132 and the fluid delivery cannula can be cooperatively configured and arranged such that, when the first insertion needle 132 is extended away from the housing 102, the first insertion needle 132 releasably carries at least a portion (e.g., a distal portion) of the fluid delivery cannula. In some examples, the first insertion needle 132 is configured to extend into a lumen 154 of the fluid delivery cannula when the first insertion needle 132 is extended away from the housing 102. The first insertion needle 132 and / or the fluid delivery cannula can be configured such that the first insertion needle 132 (e.g., the first needle distal end 142) mechanically engages the fluid delivery cannula when the first insertion needle 132 is extended in a direction away from the housing 102 and disengages the fluid delivery cannula when the first insertion needle 132 is retracted in a direction toward the housing 102. Figure 4、 Figure 5A to Figure 5C )。

[0089] In an example, when the first insertion needle 132 is in the first, undeployed position, with the first needle distal end 142 within the housing 102, Figure 5A ), the insertion device 124 can be configured to maintain separation between the first medical device 120 (e.g., a fluid delivery cannula) and the first insertion needle 132. For example, the insertion device 124 can be configured to maintain separation between the first insertion needle 132 and the first medical device 120 using the first septum 212 Figure 4 、 Figure 5A to Figure 5C ). The first septum 212 can be a self-sealing material that spans a hole defined in the first conduit 156. The insertion device 124 can be configured such that, when the first insertion needle 132 is extended (e.g., along path SI), the insertion needle 132 (e.g., the first distal end 142) punctures the first septum 212 before engaging the first medical device 120.

[0090] The first insertion needle 132 can be configured to engage the first medical device 120 to cause at least a portion of the first medical device 120 to translate in a direction away from the housing 102 (e.g., substantially along path SI). The first insertion needle 132 can be configured to exert a force on the first medical device 120 in a direction away from the housing 102 to cause translation of the first medical device 120. For example, the first insertion needle 132 and / or the first medical device 120 can include a first structural feature configured to exert a force on the first medical device 120 in a direction away from the housing 102 when the first insertion needle 132 (e.g., the first distal end 142) is extended in a direction away from the housing 102. In an example, the first insertion needle 132 is configured to enter the lumen 154 to engage the first medical device 120. The first insertion needle 132 can be configured to engage the first medical device 120 to cause the first medical device to at least partially implant within a patient when the first insertion needle 132 is extended in a direction away from the housing 102 into the patient. The first medical device 120 (e.g., a fluid delivery cannula) can be configured to extend from the device housing 102 when the first insertion needle 132 causes the first medical device 120 to at least partially implant within the patient. The first insertion needle 132 can be configured to disengage (e.g., release) from the first medical device 120 when the first insertion needle 132 (e.g., the first distal end 142) is subsequently retracted by the insertion device 124 in a direction toward the housing 102. For example, the first insertion needle 132 and / or the first medical device 120 can include a structural feature (the same or a different structural feature than the first structural feature) configured to allow the first insertion needle 132 to move substantially independently of the first medical device 120 when the insertion device 124 retracts the first insertion needle 132 toward the housing 102.

[0091] In an example, the first insertion needle 132 is configured to substantially cooperate with the first medical device 120 when a force is applied on the first insertion needle 132 in a direction away from the housing 102. The first insertion needle 132 can be configured such that a subsequent force toward the housing 102 causes the first insertion needle 132 to disengage (e.g., dislodge) the first medical device 120 and move independently thereof. In an example, the first insertion needle 132 includes a bearing surface configured such that when a force in a direction away from the housing 102 is applied on the first insertion needle 132, the bearing surface engages a portion of the first medical device 120 and transmits a portion of the force to the first medical device 120, and when a force toward the housing 102 is applied on the first insertion needle 132, the bearing surface disengages the portion of the first medical device 120 such that the first insertion needle 132 moves independently of the first medical device 120. Thus, the insertion device 124 can be configured to independently retract the first insertion needle 132 from the first medical device 120 in a direction toward the housing 102 such that the first medical device 120 remains at least partially implanted while the first insertion needle 132 is retracted.

[0092] The insertion device 124 can be configured to retract the first insertion needle 132 to a first stowed position in which the first needle distal end 142 is within the housing 102. The insertion device 124 can retract the first insertion needle 132 such that the first needle distal end 142 is retracted through the first septum 212. The first septum 212 can be configured to self-seal upon retraction of the first needle distal end 142 so as to establish a fluid barrier between the first catheter 156 and other components of the therapy delivery device 100, such as the driver 150, the processor 166 including processing circuitry, the storage element 168, and other portions of the therapy delivery device 100 that can be adversely affected by contact with fluid within the first catheter 156.

[0093] As discussed, the second insertion needle 134 can be configured to releasably engage the second medical device 122 to cause the second medical device 122 to at least partially implant into the patient. In examples, the second medical device 122 is an analyte sensor configured to monitor a physiological characteristic (e.g., glucose level) of the user. The second insertion needle 134 and the analyte sensor can be cooperatively configured and arranged such that, when the second insertion needle 134 (e.g., the second needle distal end 144) extends in a direction away from the housing 102, the second insertion needle 132 releasably carries at least a portion (e.g., a distal portion) of the analyte sensor. In some examples, the second insertion needle 134 is configured to at least partially surround the analyte sensor to carry the analyte sensor as the second insertion needle 134 extends away from the housing 102. The second insertion needle 134 can be configured as a partially hollow needle that defines a void within which the analyte sensor is housed. The second insertion needle 134 and / or the analyte sensor can be configured such that, when the second insertion needle 134 extends in a direction away from the housing 102, the second insertion needle 134 mechanically engages the analyte sensor and disengages the analyte sensor when the second insertion needle 134 retracts in a direction toward the housing 102.

[0094] The second insertion needle 134 can be configured to engage the second medical device 122 to cause the second medical device 122 to translate in a direction away from the housing 102. The second insertion needle 134 can be configured to exert a force on the second medical device 122 in a direction away from the housing 102 to cause translation of the second medical device 122. The second insertion needle 134 and / or the second medical device 122 can include a second structural feature (e.g., a void defined by the second insertion needle) configured to cause the second insertion needle 134 to exert a force on the second medical device 122 when the second insertion needle 134 extends in a direction away from the housing 102. The second insertion needle 134 can be configured to engage the second medical device 122 to cause the second medical device 122 to at least partially implant into the patient when the second insertion needle 134 extends in a direction away from the housing 102. The second medical device 122 (e.g., the analyte sensor) can be configured to extend from the device housing 102 when the second insertion needle 134 causes the second medical device 122 to at least partially implant into the patient.

[0095] The second insertion needle 134 can be configured to disengage (e.g., release) from the second medical device 122 when the second insertion needle 134 is subsequently retracted in a direction toward the housing 102. For example, the second insertion needle 134 and / or the second medical device 122 can include a structural feature (the same or a different structural feature than the second structural feature) configured to allow the second insertion needle 134 to move substantially independently of the second medical device 122 when the insertion device 124 retracts the second insertion needle 134 toward the housing 102. In some examples, the second insertion needle 134 is configured such that when the second insertion needle 134 is retracted, body tissue within the patient engages the second medical device 122 (e.g., the analyte sensor) such that the second medical device 122 remains at least partially implanted within the patient when the second insertion needle 134 is withdrawn from the patient. For example, the second insertion needle 134 can 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 the second insertion needle 134 and the second medical device 122 are inserted into the patient. When the second insertion needle 134 is retracted, the body tissue can be used to grip (e.g., frictionally engage) the exposed portion of the analyte sensor such that the second insertion needle 134 can be retracted into the housing 102 while the second medical device 122 remains at least partially implanted within the patient. In examples, the second medical device 122 (e.g., the analyte sensor) can include one or more structural features configured to assist in the frictional engagement with the body tissue.

[0096] In examples, the therapy delivery device 100 can be configured to prevent bodily fluids from entering the device 100 via the aperture 114. This can protect portions of the device 100, such as the driver 150, the processor 166, the storage element 168, and other portions of the device 100 that can be adversely affected by contact with fluids from a user. In examples, the device 100 includes a second septum 214 Figure 4 configured to maintain a fluid barrier between portions of the device 100 and the aperture 114. The insertion device 124 can be configured such that when the second insertion needle 134 is extended in a direction away from the housing 102, the second insertion needle 134 (e.g., the second needle distal end 144) punctures the second septum 214. The second septum 214 can be composed of a self-sealing material such that the second septum 214 substantially closes around the second insertion needle 134 and / or the second medical device 122 to substantially maintain a fluid barrier between portions of the device 100 and the patient.

[0097] The insertion device 124 can be configured to retract the second insertion needle 134 to a second retracted position, with the second distal end 142 within the housing 102. The insertion device 124 can retract the second insertion needle 134 such that the second needle distal end 144 is retracted through the second septum 214. The second septum 214 can be configured to self-seal (e.g., around the second medical device 122) upon the second needle distal end 144 being retracted through the second septum 214, so as to substantially maintain a fluid barrier between components of the device 100 and the patient.

[0098] As described above, in some embodiments, the insertion device 124 can be separate from and external to the therapy delivery device 100. Thus, the housing 126 of the insertion device 124 can be configured to couple with the housing 102 of the therapy delivery device 100 to insert the medical devices 120 and 122 into the patient. For example, the insertion device 124 can include the driver 150; the shaft 140; and the needles 132 and 134, while the therapy delivery device 100 can include the first catheter 156; the septum 212 and the septum 214; and the medical devices 120 and 122. Referring back to Figure 5A For visual reference, the housing 126 can be mounted on the housing 102 such that the second insertion needle 134 is aligned with the second medical device 122; the septum 214; and the aperture 114, and such that the first needle distal end 142 of the first insertion needle 132 is aligned with the septum 212.

[0099] The second medical device 122 can be manufactured using a flexible or pliable substrate or carrier. In an example, the second medical device 122 (e.g., an analyte sensor) can be coupled to a wire that is initially provided in a folded, serpentine, coiled, or accordion shape, for example, to provide a desired amount of slack to accommodate extension of the second medical device 122 while the second medical device 122 is electrically coupled to the insertion device 124 (e.g., to the electronic assembly 171 Figure 4 The second medical device 122 can be configured such that, as the second insertion needle 134 carries the second medical device 122 in a distal direction away from the housing 126 (e.g., along the path S2), the second medical device 122 extends 171 without losing electrical contact with the electronic assembly. In some examples, the second medical device 122 is configured to establish electrical coupling (e.g., with the electronic assembly 171) after the insertion device 124 has been triggered. For example, the second medical device 122 can include electrical contact pads that are configured to electrically connect with one or more connectors of the device 100 upon or as the second insertion needle 132 at least partially implants the second medical device 122 into the patient.

[0100] Techniques for at least partially implanting a first medical device and a second medical device are shown in Figure 8 U.S. Patent Application No. 16 / 182, 1 13, filed November 8, 2018, entitled “Systems and Methods for Implanting a Medical Device,” which claims priority to U.S. Provisional Patent Application No. 62 / 565, 1 13, filed September 28, 2017, entitled “Systems and Methods for Implanting a Medical Device,” which are hereby incorporated by reference in their entirety. Figure 1The technology is described with respect to various devices in FIG. 7, but in other examples, the technology can be applied to other devices as well.

[0101] The technology includes using the first insertion needle 132 to carry the distal end of the first medical device 120 along the curved path SI through the aperture 114 in the device housing 102 (220). The technology can include rotating the shaft 140 relative to the housing 102. The shaft 140 can be rotated about the longitudinal axis L in the first rotational direction Rl. The shaft 140 can be rotated using the driver 150. The technology can include rotating the shaft 140 in the first rotational direction Rl using a first torque applied by the driver 150. In an example, the driver 150 includes a first spring 172. The technology can include applying the first torque on the shaft 140 using the first spring 172.

[0102] The technology includes using the second insertion needle 134 to carry the second medical device through the aperture 114 (222). The technology can include inserting the second insertion needle 134 such that the distal end of the second medical device 122 is increasingly distanced from the distal end of the first medical device 120 as the distal end of the first medical device 120 is carried along the curved path.

[0103] The technology can include using rotation of the shaft 140 in the first rotational direction Rl to extend the first insertion needle 132 and the second insertion needle 134 through the aperture 114. The technology can include extending the first insertion needle 132 and the second insertion needle 134 in a direction away from the housing 102. In an example, the technology includes using rotation of the shaft 140 in the first rotational direction Rl to move the first needle distal end 142 from a first un-deployed position within the housing 102 to a first deployed position outside of the housing 102. The technology can include moving the first needle distal end 142 along the path SI. In an example, the technology includes using rotation of the shaft 140 in the first rotational direction Rl to move the second needle distal end 144 from a second un-deployed position within the housing 102 to a second deployed position outside of the housing 102. The technology can include moving the second needle distal end 144 along the path S2. In an example, the path SI has a first curvature relative to the axis L and the path S2 has a second curvature relative to the axis L, and the first curvature is greater than the second curvature. In an example, the path S2 is a substantially linear path.

[0104] The technology can include applying a torque about the longitudinal axis L on the first insertion needle 132 when the shaft is rotated in the first rotational direction Rl. In an example, the first insertion needle 132 is a curved needle. The technology can include using the torque applied on the first insertion needle 132 to cause the first needle distal end 142 to travel along the path SI. In an example, the insertion device 124 includes a strut 178 configured to transmit the torque from the shaft 140 to the first insertion needle 132. In an example, the insertion device 124 includes a pinion gear coupled to the shaft 140 and a curved rack gear coupled to the first insertion needle 132 such that the pinion gear meshes with the curved rack gear to transmit the torque from the shaft 140 to the first insertion needle 132. In an example, a surface of the shaft 140 is configured to frictionally engage a surface of the first insertion needle 132 to transmit the torque from the shaft 140 to the first insertion needle 132.

[0105] The technology can include applying a substantially linear force on the second insertion needle 134 when the shaft is rotated in the first rotational direction Rl. In an example, the second insertion needle 134 is a substantially straight needle. The technology can include using the substantially linear force applied on the second insertion needle 134 to cause the second needle distal end 144 to travel along the path S2. In an example, the insertion device 124 is configured to cause the pinion gear 180 to rotate about the longitudinal axis L. The pinion gear 180 can be configured to mesh with a rack gear 182 coupled to the second insertion needle 134 to apply the substantially linear force on the second insertion needle 134. In an example, a surface of the shaft 140 is configured to frictionally engage a surface of the second insertion needle 134 to transmit the substantially linear force to the second insertion needle 134.

[0106] In an example, the technology includes causing the first needle distal end 142 and the second needle distal end 144 to extend through the aperture 114 defined by the housing 102. In an example, the technology includes causing the first needle distal end 142 and / or the second needle distal end 144 to pierce the user's skin 118. The technology can include causing the first needle distal end 142 and the second needle distal end 144 to insert through the user's skin 118 within an insertion site 175 on the user's skin 118. In an example, the technology includes piercing the skin 118 at the puncture site with one of the first insertion needle 132 or the second insertion needle 134 and inserting the other of the first insertion needle 132 or the second insertion needle 134 through the skin 118 at the puncture site.

[0107] The technology can include at least partially implanting the first medical device 120 into the user by extending the first insertion needle 132, and at least partially implanting the second medical device 122 into the user by extending the second insertion needle 134. In an example, the first medical device 120 is a fluid delivery cannula configured to deliver a medical fluid (e.g., insulin). In an example, the second medical device 122 is an analyte sensor (e.g., a glucose sensor) configured to sense a physiological characteristic of the user (e.g., a glucose level). In an example, the insertion device 124 is configured to cause the at least partial implantation such that the first medical device 120 and the second medical device 122 are separated by a displacement D when at least partially implanted into the user.

[0108] The technology can include rotating the shaft 140 in a second rotational direction R2 that is substantially opposite the first rotational direction Rl. The technology can include using the rotation of the shaft 140 in the second rotational direction R2 to retract the first insertion needle 132 and the second insertion needle 134. The technology can include retracting the first insertion needle 132 and the second insertion needle 134 in a direction toward the housing 102. In an example, the technology includes using the rotation of the shaft 140 in the second rotational direction R2 to move the first needle distal end 142 from a first deployed position to a first stowed position inside the housing 102. The technology can include causing the first needle distal end 142 to move along a path SI. In an example, the technology includes using the rotation of the shaft 140 in the second rotational direction R2 to move the second needle distal end 144 from a second deployed position to a second stowed position inside the housing 102. The technology can include causing the second needle distal end 144 to move along a path S2.

[0109] The technology can include applying a torque about the longitudinal axis L on the first insertion needle 132 as the shaft is rotated in the second rotational direction R2. The technology can include using the second torque applied on the first insertion needle 132 to cause the first needle distal end 142 to travel along the path SI. The technology can include applying a substantially linear force on the second insertion needle 134 as the shaft 140 is rotated in the second rotational direction R2. The technology can include using the substantially linear force applied on the second insertion needle 134 to cause the second needle distal end 144 to travel along the path S2.

[0110] The technique includes retracting the first insertion needle 132 toward the housing 102 using rotation of the shaft 140 in the second rotational direction R2 to withdraw the first insertion needle 132 from the user. In an example, the technique includes causing the first insertion needle 132 to release the first medical device 120 as the first insertion needle 132 is retracted toward the housing 102. The technique can include causing the first insertion needle 132 to mechanically decouple from the first medical device 120 such that the first medical device 120 remains at least partially implanted in the user as the first insertion needle 132 is retracted toward the housing 102. The technique can include causing the first insertion needle 132 to move independently of the first medical device 120 during retraction of the first insertion needle 132 such that the first medical device 120 remains at least partially implanted in the user as the first insertion needle 132 is retracted toward the housing 102.

[0111] The technique includes retracting the second insertion needle 134 toward the housing 102 using rotation of the shaft 140 in the second rotational direction R2 to withdraw the second insertion needle 134 from the user. In an example, the technique includes causing the second insertion needle 134 to release the second medical device 122 as the second insertion needle 134 is retracted toward the housing 102. The technique can include causing the second insertion needle 134 to mechanically decouple from the second medical device 122 such that the second medical device 122 remains at least partially implanted in the user as the second insertion needle 134 is retracted toward the housing 102. The technique can include causing the second insertion needle 134 to move independently of the second medical device 122 during retraction of the second insertion needle 134 such that the second medical device 122 remains at least partially implanted in the user as the second insertion needle 134 is retracted toward the housing 102.

[0112] The technique can include rotating the shaft 140 by applying torque on the shaft 140 using a spring. In an example, the technique includes rotating the shaft 140 in the first rotational direction Rl by applying torque on the shaft 140 in the first rotational direction Rl using the first spring 172. In an example, the technique includes rotating the shaft 140 in the second rotational direction R2 by applying torque on the shaft 140 in the second rotational direction R2 using the second spring 174. In an example, the technique includes initially rotating the shaft 140 in the first rotational direction Rl and subsequently rotating the shaft 140 in the second rotational direction R2. In an example, the driver 150 is configured to initially rotate the shaft 140 in the first rotational direction Rl and subsequently rotate the shaft 140 in the second rotational direction R2.

[0113] In an example, the technique includes using the user input device 108 to actuate the driver 150 to cause implantation of at least a portion of the first medical device 120 and the second medical device 122. In an example, the user input device 108 is configured to cause the driver 150 to rotate the shaft 140 in the first rotational direction Rl. In an example, the user input device 108 is configured to cause the driver 150 to rotate the shaft 140 in the second rotational direction R2. In an example, the user input device 108 is configured to cause the driver 150 to initially rotate the shaft 140 in the first rotational direction Rl and subsequently rotate the shaft 140 in the second rotational direction R2. In some examples, the technique includes pressing a button on the housing 102 to cause the user input device 108 to initiate at least partial implantation of the first medical device 120 and the second medical device 122. In some examples, the technique includes transmitting an electrical communication (e.g., a wired or wireless communication) to the user input device 108 to initiate at least partial implantation of the first medical device 120 and the second medical device 122.

[0114] The housing 126 can be configured to support at least the driver 150, the first insertion needle 132, and the second insertion needle 134. The housing 126 can be configured to engage (e.g., mechanically engage) the device housing 102 of the therapy delivery device 100. The technique can include positioning at least the first insertion needle 132 and the second insertion needle 134 in close proximity to the user's skin 118 by mounting the housing 126 on top of the housing 102. The technique can include separating the housing 126 and the housing 102 when the first medical device 120 and the second medical device 122 are at least partially implanted in the user.

[0115] The techniques and functions described in this disclosure, including those attributed to the processor 166, processing circuitry, sensors, and / or various constituent components, can be implemented, at least in part, in hardware, software, firmware or any combination thereof. For example, various aspects of the techniques can 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, within any appropriate device. The processing circuitry, control circuitry, and sensing circuitry, as well as other processors, controllers, and sensors described herein, can be implemented at least partially in hardware, which can include, for example, one or more application specific integrated circuits (ASICs), digital signal processors (DSPs), digital signal processing devices (DSPDs), programmable logic devices (PLDs), field programmable gate arrays (FPGAs), processors, controllers, micro-controllers, microprocessors, other integrated circuits, and / or any other equivalents.

[0116] In one or more examples, the techniques and functionalities described in this disclosure can be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functions can be stored as one or more instructions or code on a computer-readable medium and executed by a hardware-based processing unit. Computer-readable media can be one or more of a type of computer-readable storage media that includes non-transitory computer-readable storage media. The instructions embodied in the computer-readable media can cause one or more programmable processors or other processors to implement one or more of the techniques described herein, for example, when instructions contained in the computer-readable media are executed by the one or more processors. Exemplary non-transitory computer-readable storage media can 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 tape, a magnetic media, an optical media, or any other computer-readable storage or tangible computer-readable medium that can contain or store the instructions.

[0117] In some examples, the computer-readable storage media includes non-transitory media. The term "non-transitory" can indicate that the storage medium is not embodied in a carrier wave or a propagated signal. In certain examples, a non-transitory storage medium can store data that can change over time, for example, in RAM or cache.

[0118] The functions described herein can be provided within dedicated hardware and / or software modules. Depiction of different features as modules or units is intended to highlight different functional aspects and does not necessarily imply that such modules or units must be realized by separate hardware or software components. Rather, functionality associated with one or more modules or units can be performed by separate hardware or software components, or integrated within common or separate hardware or software components. Also, the techniques can be fully implemented in one or more circuits or logic elements.

[0119] The present disclosure includes the following examples.

[0120] Example 1 : An apparatus comprising: a first insertion needle configured to transport a distal end of a first medical device along a curved path through an opening in an apparatus housing; and a second insertion needle configured to transport a distal end of a second medical device through the opening in the apparatus housing, wherein the first insertion needle transports the distal end of the first medical device such that the distal end of the first medical device moves further away from the distal end of the second medical device as the distal end of the first medical device is transported along the curved path.

[0121] Example 2: The apparatus of Example 1, wherein the first medical device is a fluid delivery catheter and the second medical device is an analyte sensor.

[0122] Example 3: The apparatus of Example 2, wherein the fluid delivery catheter is a cannula.

[0123] Example 4: The apparatus of any of Examples 1 -3, wherein the second insertion needle is configured to releasably transport the second medical device based on housing the second medical device within the second insertion needle.

[0124] Example 5: The apparatus of any of Examples 1 -4, wherein the first insertion needle is configured to releasably transport the first medical device based on being at least partially inserted within a lumen defined by the first medical device.

[0125] Example 6: The apparatus of any of Examples 1 -5, wherein the first insertion needle is configured to release the first medical device when the first insertion needle is retracted toward the apparatus housing, and the second insertion needle is configured to release the second medical device when the second insertion needle is retracted toward the apparatus housing.

[0126] Example 7: The apparatus of any of Examples 1 -6, further comprising a shaft configured to rotate about a longitudinal axis of rotation, the shaft configured to cause the first insertion needle and the second insertion needle to pass through the opening in the apparatus housing substantially simultaneously when the shaft is rotated in a first rotational direction about the longitudinal axis.

[0127] Example 8: The apparatus of Example 7, wherein the second insertion needle comprises a rack gear, wherein the shaft is coupled to a pinion gear, and wherein the rack gear is configured to mesh with the pinion gear when the shaft is rotated about the longitudinal axis.

[0128] Example 9: The apparatus of Example 7 or 8, further comprising a first torsion spring configured to exert a torque on the shaft to cause the shaft to rotate in the first rotational direction.

[0129] Example 10: The apparatus of any of examples 7-9, wherein the shaft is configured to cause the first insertion needle and the second insertion needle to retract substantially simultaneously through the opening in the apparatus housing when the shaft is rotated in a second rotational direction opposite the first rotational direction.

[0130] Example 11 : The apparatus of example 10, further comprising a second torsion spring configured to cause the shaft to rotate in the second rotational direction.

[0131] Example 12: The apparatus of example 11, wherein: the first torsion spring has a first spring rate when the shaft is rotated in the first rotational direction, the second torsion spring has a second spring rate when the shaft is rotated in the second rotational direction, and the first spring rate is less than the second spring rate.

[0132] Example 13: The apparatus of any of examples 1-12, further comprising: a second apparatus housing external to the apparatus housing, the second apparatus housing configured to engage and disengage the apparatus housing.

[0133] Example 14: The apparatus of any of examples 1-13, wherein the second insertion needle is configured to carry the distal end of the second medical device along a second curved path through the opening in the apparatus housing.

[0134] Example 15: The apparatus of any of examples 1-14, wherein the first insertion needle is integrally formed with the first medical device.

[0135] Example 16: The apparatus of any of examples 1-15, wherein the second insertion needle is integrally formed with the second medical device.

[0136] Example 17: The apparatus of any of examples 1-16, further comprising: a fluid delivery channel configured to facilitate fluid connection between a fluid reservoir and the opening in the apparatus housing; and a septum configured to seal an opening in the fluid delivery channel, wherein the curved path passes through the septum and the opening in the apparatus housing.

[0137] Example 18: The apparatus of any of examples 1-17, wherein the second insertion needle is configured to define a substantially straight path through the opening in the apparatus housing.

[0138] Example 19: A method comprising: using a first insertion needle to carry a distal end of a first medical device along a curved path through an opening in a device housing; using a second insertion needle to carry a second medical device through the opening in the device housing such that the distal end of the second medical device is increasingly further away from the distal end of the first medical device as the distal end of the first medical device is carried along the curved path.

[0139] Example 20: The method of example 19, further comprising rotating a shaft in a first rotational direction, wherein the first insertion needle and the second insertion needle are operatively connected to the shaft, and wherein the shaft is configured to cause the first insertion needle and the second insertion needle to pass through the opening in the device housing substantially simultaneously when the shaft is rotated about a longitudinal axis in the first rotational direction.

[0140] Various examples have been described. These are other examples within the scope of the disclosure.

Claims

1. A medical device comprising: A first insertion needle is configured to deliver the distal end of a first medical device along a curved path through an opening in the device housing; A second insertion needle, configured to deliver the distal end of a second medical device through the opening in the device housing; as well as A shaft configured to rotate about a longitudinal axis, the shaft being configured such that when the shaft rotates about the longitudinal axis in a first rotational direction, the first insertion pin and the second insertion pin simultaneously pass through the opening in the device housing; The curved path bends around the longitudinal axis, and the first insertion needle transports the distal end of the first medical device such that as the distal end of the first medical device is transported along the curved path, the distal end of the first medical device moves further and further away from the distal end of the second medical device.

2. The medical device according to claim 1, wherein the first medical device is a fluid delivery conduit, and the second medical device is an analyte sensor.

3. The medical device according to claim 2, wherein the fluid delivery catheter is an intubation cannula.

4. The medical device of claim 1, wherein the second insertion needle is configured to releasably transport the second medical device based on receiving the second medical device within the second insertion needle.

5. The medical device of claim 1, wherein the first insertion needle is configured to releasably deliver the first medical device based on being at least partially inserted into a cavity defined by the first medical device.

6. The medical device of claim 1, wherein the first insertion needle is configured to release the first medical device when the first insertion needle retracts toward the device housing, and the second insertion needle is configured to release the second medical device when the second insertion needle retracts toward the device housing.

7. The medical device according to claim 1, further comprising a pinion gear, wherein the shaft is connected to the pinion gear; The second insertion pin includes a rack and pinion, wherein the rack and pinion is configured to engage with the pinion when the shaft rotates about the longitudinal axis.

8. The medical device of claim 1, further comprising a first torsion spring configured to apply torque on the shaft to cause the shaft to rotate in the first rotational direction.

9. The medical device of claim 8, wherein the shaft is configured to cause the first insertion needle and the second insertion needle to retract simultaneously through the opening in the device housing when the shaft is rotated in a second rotational direction opposite to the first rotational direction.

10. The medical device of claim 9, further comprising a second torsion spring configured to rotate the shaft in the second rotational direction.

11. The medical device according to claim 10, wherein: When the shaft rotates in the first rotational direction, the first torsion spring has a first spring ratio. When the shaft rotates in the second rotational direction, the second torsion spring has a second spring ratio, and The first spring ratio is less than the second spring ratio.

12. The medical device according to claim 1, comprising: A second device housing outside the device housing, the second device housing being configured to engage and disengage from the device housing.

13. The medical device of claim 1, wherein the second insertion needle is configured to deliver the distal end of the second medical device along a second curved path through the opening in the device housing.

14. The medical device according to claim 1, wherein the first insertion needle is integrally formed with the first medical device.

15. The medical device of claim 1, wherein the second insertion needle is integrally formed with the second medical device.

16. The medical device according to claim 1, further comprising: A fluid delivery channel configured to facilitate fluid connection between a fluid reservoir and the opening in the device housing; as well as A diaphragm configured to seal an opening in the fluid delivery channel, wherein the tortuous path passes through the diaphragm and the opening in the device housing.

17. The medical device of claim 1, wherein the second insertion needle is configured to define a straight path through the opening in the device housing.

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