Infusion device

Abstract

An infusion device configured to implant a cannula and a sensor in a user. The infusion device includes a first unit defining a first housing and a second unit defining a second housing. The second housing is configured to engage the first housing. The infusion device includes a first insertion needle configured to implant the cannula in the user and a second insertion needle configured to implant the sensor in the user when the second unit engages the first unit. The infusion device includes a processing circuit in electrical communication with the sensor and a fluid reservoir in fluid communication with the cannula. In an example, the first unit and the second unit are configured to engage using an inserter.

Description

Technical Field

[0001] This disclosure generally relates to systems for inserting medical devices. Background Technology

[0002] According to modern medical technology, certain diseases or conditions can be treated by delivering fluids of medication or other substances to a patient's body continuously or at specific times or intervals throughout a period of time. For example, diabetes is often treated by delivering a predetermined amount of insulin to the patient at appropriate times. Some modern systems use programmable fluid infusion devices (e.g., insulin pumps) to deliver controlled amounts of insulin to patients. Some modes of providing insulin therapy to users include delivery via manually operated syringes and insulin pens. Other modes use programmable fluid infusion devices (e.g., insulin pumps) to deliver controlled amounts of insulin to the user. In addition, in some cases, it may be necessary for the user to receive feedback from a physiological characteristic monitor (e.g., a glucose monitor). In these cases, the physiological characteristic monitor and infusion kit are typically coupled to the user's anatomy at different insertion sites. Summary of the Invention

[0003] This disclosure generally relates to an infusion device configured to implant a cannula and a sensor within a user's body. The infusion device can be configured to be worn by the user. The infusion device may include a first unit configured to contact the user's skin and a second unit configured to engage the first unit. The second unit includes a first insertion needle configured to implant a cannula and a second insertion needle configured to implant a sensor when the second unit engages the first unit. The infusion device is configured to fluidly connect the cannula to a fluid reservoir within the first unit and electrically connect the sensor to processing circuitry within the first unit to engage the second unit. The first unit may be configured to substantially restrict movement of the second unit relative to the first unit when the second unit engages the first unit.

[0004] The infusion device can be configured to withdraw the first and second insertion needles when the second unit engages with the first unit. The infusion device is configured such that the cannula and sensor remain implanted while the insertion needles are withdrawn and the second unit engages with the first unit. The second unit can be configured such that the cannula and sensor are withdrawn from the user when the user disengages the second unit from the first unit. The infusion device is configured such that the second unit can be replaced while the first unit remains close to the user.

[0005] In one example, an infusion device includes: a first unit defining a first housing, wherein the first housing defines a first channel extending through the first housing, a second channel extending through the first housing, and a fluid passage, wherein the first unit includes processing circuitry and a fluid reservoir in fluid communication with the fluid passage; and a second unit defining a second housing configured to engage the first housing, the second unit including: a cannula having a first end and a second end; and a sensor; a first insertion needle releasably carrying the cannula; and a second insertion needle releasably carrying the sensor, wherein: the first insertion needle is configured to insert the first end of the cannula through the first channel when the second housing engages the first housing, the second insertion needle is configured to insert the sensor through the second channel when the second housing engages the first housing, the second end of the cannula is configured to insert through the fluid passage when the second housing engages the first housing, and the infusion device is configured to electrically connect the sensor and the processing circuitry when the second housing engages the first housing.

[0006] In one example, an infusion device includes: a first unit defining a first housing, wherein the first housing defines a first channel extending through the first housing, a second channel extending through the first housing, and a fluid passage, and wherein the first unit includes processing circuitry, a fluid reservoir, and a fluid pump in fluid communication with the fluid passage; and a second unit defining a second housing configured to engage the first housing, the second unit including: a cannula having a first end and a second end; and a sensor; a first insertion needle releasably carrying the cannula and configured to extend through the first channel; and a second insertion needle releasably carrying the sensor and configured to extend through the second channel, wherein: the first housing is configured to when the first insertion needle is engaged with the second channel, the second unit includes: a cannula having a first end and a second end; and a sensor; a first insertion needle releasably carrying the cannula and configured to extend through the first channel; and a second insertion needle releasably carrying the sensor and configured to extend through the second channel, wherein: the first housing is configured to engage the second insertion needle with the second insertion needle. When the two housings engage the first housing, the second housing is substantially fixed and does not move relative to the first housing. The first insertion needle is configured such that when the first insertion needle extends through the first channel, a portion of the cannula, including the first end, extends through the first channel. The second insertion needle is configured such that when the second insertion needle extends through the second channel, a portion of the sensor extends through the second channel. The second end of the cannula is configured to be inserted through a fluid passage when the second housing engages the first housing. The cannula is configured to establish fluid communication from the first end of the cannula to the fluid reservoir when the second end of the cannula is inserted through the fluid passage. The infusion device is configured to electrically connect the sensor and the processing circuit when the second housing engages the first housing.

[0007] In one example, a technique includes: engaging a first housing defined by a first unit and a second housing defined by a second unit, wherein the first unit includes processing circuitry and a fluid reservoir, and wherein the second unit includes a first insertion needle, a second insertion needle, a cannula, and a sensor; inserting a first end of the cannula through a first channel defined by the first housing using the first insertion needle when the second housing engages the first housing; inserting the sensor through a second channel defined by the first housing using the second insertion needle when the second housing engages the first housing; inserting a second end of the cannula into a fluid passage defined by the first housing when the second housing engages the first housing; and electrically connecting the sensor to the processing circuitry when the second housing engages the first housing.

[0008] Details of one or more examples are illustrated in the accompanying drawings and the following description. Other features, objectives, and advantages will become apparent from the description, the accompanying drawings, and the claims. Attached Figure Description

[0009] Figure 1 This is a schematic diagram of an infusion device attached to a user's body.

[0010] Figure 2 This is a simplified block diagram representation of an infusion device.

[0011] Figure 3 A schematic side view of an infusion device attached to a user's body.

[0012] Figure 4A This is a schematic diagram of the first and second units.

[0013] Figure 4B To present another configuration Figure 4A A schematic diagram of the first and second units.

[0014] Figure 4C To present different configurations Figure 4A and Figure 4B A schematic diagram of the first and second units.

[0015] Figure 5 A schematic diagram of the second unit aligned with the first unit.

[0016] Figure 6A This is the first view of the inserter and the second unit.

[0017] Figure 6B for Figure 6A The inserter and the second view of the second unit.

[0018] Figure 7 This is a schematic diagram of the second unit.

[0019] Figure 8A This is a schematic diagram of the inserter in its first configuration.

[0020] Figure 8B For the second configuration Figure 8A A schematic diagram of the inserter.

[0021] Figure 8C For the third configuration Figure 8A and Figure 8B A schematic diagram of the inserter.

[0022] Figure 8D For the fourth configuration Figure 8A , Figure 8B and Figure 8C A schematic diagram of the inserter.

[0023] Figure 9 This section describes an example technique using an infusion device. Detailed Implementation

[0024] This disclosure describes an infusion device configured to implant a cannula and a sensor within a user's body. The infusion device may generally relate to a fluid delivery device configured to provide a therapeutic fluid to a user and monitor the user's physiological characteristics. For example, the cannula may be a fluid delivery cannula configured to deliver fluid (e.g., insulin) to the user. The sensor may be an analyte sensor (e.g., a glucose sensor) configured to detect the user's physiological characteristics (e.g., glucose levels). The infusion device may be configured to implant the cannula and sensor substantially simultaneously within the user's body, but examples are not limited to substantially simultaneous implantation of the cannula and sensor. In examples, the infusion device is a portable system configured to be worn by the user.

[0025] The infusion device includes a first unit configured to engage a second unit. The first and second units may be substantially separate units. For example, the first unit may include one or more components substantially mechanically supported and / or housed within a first housing, and the second unit may include one or more components substantially mechanically supported and / or housed within a second housing. The second unit (e.g., the second housing) may be configured to engage the first unit (e.g., the first housing) such that the components of the first and second units operate cooperatively for therapeutic benefit to the user.

[0026] In examples, the infusion device is configured such that a second unit can be engaged (e.g., mounted on) and / or disengaged (e.g., detached from) the first unit by a user's actions. For instance, a user may mount the second unit onto the first unit to initiate use of the cannula, sensor, and other components of the infusion device. The user may detach the second and first units after use. In examples, the first unit is configured to be positioned on the user (e.g., on the user's skin), and the second unit can be mounted and removed while the first unit is positioned on the user. The second unit may be substantially replaceable, such that a particular second unit initially mounted on the first unit can be removed by the user and replaced by another similar and / or substantially identical second unit. In some examples, the infusion device is configured such that the second unit can be replaced while the first unit remains positioned on the user.

[0027] The first unit can be configured to restrict movement of the second unit relative to the first unit when the second unit engages with the first unit. In an example, the second housing of the second unit is configured to engage (e.g., mechanically engage) the first housing of the first unit to restrict movement of the second housing relative to the first housing. The second housing can be configured to engage the first housing such that components of the first unit and components of the second unit cooperate to deliver a therapeutic fluid (e.g., insulin) to the user using a cannula and to monitor the user's physiological characteristics (e.g., glucose levels) using sensors.

[0028] The infusion device can be configured to implant a cannula and a sensor into a user's body. In an example, the infusion device is configured to implant the cannula and the sensor during the mounting of a second unit onto a first unit. The second unit may include a first insertion needle configured to implant the cannula and a second insertion needle configured to implant the sensor. The first and second insertion needles may releasably carry the cannula and the sensor, respectively. The infusion device can be configured to implant the cannula and the sensor into the user's body when the second unit engages or is caused to engage the first unit. For example, the infusion device can be configured such that when the second unit engages the first unit (e.g., by the user), the first and second insertion needles extend from the infusion device to induce implantation.

[0029] In this example, the cannula is an insulin cannula, and the sensor is a glucose sensor. The infusion device (e.g., in the first unit) includes two systems—the glucose sensor and the insulin cannula—that enable a “closed-loop” system, allowing for real-time adjustment of the insulin delivered to the user based on readings from the glucose sensor. This real-time adjustment helps maintain the user's glucose levels. Furthermore, this reduces the need for the user to carry separate insulin infusion and glucose monitoring devices. Including both the insulin cannula and the glucose sensor provides a more user-carryable infusion device and reduces / and / or limits the number of insertion sites required.

[0030] In one example, the infusion device is configured to implant a cannula and a sensor when the first unit is positioned on a user (e.g., on the user's skin). A first and second insertion needle may be configured to extend from and through the second unit to induce implantation when the second unit engages with the first unit, such that the distal ends of the first and second insertion needles pierce the user's skin. In another example, the infusion device is configured such that when the first and second insertion needles induce implantation, a first housing of the first unit is positioned between the second housing of the second unit and the user. The infusion device may be configured such that when the first unit is positioned on the user, movement of the second unit toward the first unit in a first direction causes the first and second insertion needles to extend through the first unit to implant the cannula and the sensor. Movement in the first direction (e.g., toward the user) may cause the second housing of the second unit to engage the first housing of the first unit, such that the first housing restricts and / or substantially prevents movement of the second housing relative to the first housing.

[0031] In one example, the infusion device is configured such that the first and second insertion needles pierce the user's skin substantially simultaneously. The infusion device may be configured such that the first and second insertion needles pierce the user's skin substantially simultaneously when the second unit engages the first unit (e.g., caused by the user). The infusion device may cause the first and second insertion needles to be inserted substantially simultaneously to, for example, limit user discomfort, which may be caused by insertions separated by temporally identifiable time increments. In other examples, the infusion device may be configured such that the first and second insertion needles are inserted with substantially different time increments.

[0032] The infusion device can be configured such that a first insertion needle and / or a second insertion needle can be withdrawn in a second direction substantially opposite to the first direction (e.g., away from the user) when the second housing remains engaged with the first housing, and the first insertion needle and / or the second insertion needle can be withdrawn from the user when the second unit remains positioned on the first unit. The first insertion needle can be configured to release the cannula when withdrawn in the second direction. The second insertion needle can be configured to release the sensor when withdrawn in the second direction.

[0033] Therefore, the infusion device can be configured such that a user can induce implantation of the cannula and sensor by causing the second unit to engage the first unit. The infusion device can be configured such that a user can induce withdrawal of the first and / or second insertion needles after implantation. In an example, the infusion device is configured such that when the first and / or second insertion needles are withdrawn in a second direction (e.g., away from the user), the first and / or second insertion needles are substantially separable from the first and second units, allowing the user to continue using the functions of the first and second units without the continued presence of the first and / or second insertion needles.

[0034] In one example, the first unit includes a fluid reservoir configured to hold fluid and processing circuitry configured to communicate with a sensor. The second unit may include a cannula and a sensor. The infusion device may be configured such that when the second housing engages the first housing, the cannula of the second unit is positioned in fluid communication with the fluid reservoir of the first unit to allow the infusion device to supply therapeutic fluid. The infusion device may be configured such that when the second housing engages the first housing, the processing circuitry is positioned in electrical communication with the sensor, allowing the sensor to communicate with the processing circuitry. In one example, the infusion device includes: a fluid pump (e.g., an insulin pump) configured to deliver therapeutic fluid from the fluid reservoir to the cannula; and processing circuitry configured to control the operation of the fluid pump (e.g., start or stop pumping) based on signals from the sensor.

[0035] The second unit is configured to support the cannula such that when the second housing engages with the first housing, the cannula establishes fluid communication with the fluid reservoir of the first unit. In one example, the cannula includes a lumen configured to establish fluid communication between a first end of the cannula (“cannula first end”) and a second end of the cannula opposite the first end (“cannula second end”). In another example, the second unit mechanically supports a portion of the cannula including the second end, such that when the second housing engages with the first housing, the second end of the cannula is inserted into the fluid passage of the first unit. A first insertion needle may be configured to implant the first end of the cannula into the user's body when the second housing engages with the first housing. Therefore, the second unit may be configured such that when the second housing engages with the first housing, fluid communication is established between the fluid reservoir of the first unit and the first end of the cannula implanted in the user's body. In another example, the second end of the cannula is configured to puncture a diaphragm that provides fluid isolation between the fluid reservoir and the first housing of the first unit to establish fluid communication.

[0036] The infusion device is configured to establish communication between a sensor in the second unit and the processing circuitry of the first unit when the second housing engages with the first housing. In one example, the first unit includes a first connector electrically connected to the processing circuitry, and the second unit includes a second connector electrically connected to the sensor. The infusion device is configured such that engagement of the second housing with the first housing causes the second connector to establish an electrical connection with the first connector, allowing the sensor (in the second unit) to provide a signal indicative of a user's physiological characteristics (e.g., glucose level) to the processing circuitry (in the first unit). The infusion device may be configured such that when the second end of the cannula is inserted into a fluid passage (e.g., when the second unit engages with the first unit), the second connector establishes an electrical connection with the first connector. In one example, the second unit is configured to mechanically support the second electrical connector and the cannula, such that engagement of the second unit and the first unit causes the second end of the cannula to be inserted into the fluid passage and causes the second connector to establish an electrical connection with the first connector.

[0037] The first unit may be configured such that a first insertion needle and / or a second insertion needle may translate relative to the first unit. The first insertion needle may translate through the first unit in a distal direction (“first needle distal direction”) and in a proximal direction opposite to the first needle distal direction (“first needle proximal direction”). The first needle may be configured to translate in the first needle distal direction to pierce the user’s skin and to translate in the first needle proximal direction to withdraw from the user’s skin.

[0038] In one example, the second unit is configured such that the first insertion needle and / or the second insertion needle can be translated relative to the second unit. For instance, the second unit may be configured such that the first insertion needle and / or the second insertion needle can be translated relative to the second unit to allow the first insertion needle and / or the second insertion needle to be withdrawn from the user while the second housing remains engaged with the first housing. In another example, the infusion device is configured such that the first insertion needle can extend and / or translate through the first unit while extending through the second unit.

[0039] The infusion device can be configured essentially as a second unit and a first unit, such that when the engagement of the second housing and the first housing causes the second end of the cannula to be inserted into the fluid passage, the first insertion needle can pass through the second unit and the first unit. The infusion device can be configured essentially as a second unit and a first unit, such that when the engagement of the second housing and the first housing causes the second connector to establish an electrical connection with the first connector, the first insertion needle can pass through the second unit and the first unit.

[0040] In one example, the infusion device includes an inserter configured to cause a second housing of a second unit to engage a first housing of a first unit. The inserter may be configured to hold the second unit in a disengaged position where the second unit is displaced from the first unit, and to cause the second unit to move to an engaged position where the second housing engages the first housing. In another example, the inserter is configured to engage with the first unit when the inserter holds the second unit in the disengaged position. The inserter may be configured to be substantially aligned with both the second and first units such that when the inserter causes engagement of the second and first housings, the components of the first and second units can cooperatively operate to deliver a therapeutic fluid (e.g., insulin) to the user using a cannula and to monitor the user's physiological characteristics (e.g., glucose levels) using sensors.

[0041] In one example, the inserter is configured such that a user can cause the inserter to move the second unit from a disengaged position to an engaged position. In another example, the inserter is configured such that when the inserter moves the second unit from the disengaged position to the engaged position, a first insertion needle is inserted into the cannula and a second insertion needle is inserted into the user's body to implant a sensor. The inserter may include a user input device configured to cause the inserter to move the second unit from the disengaged position to the engaged position, allowing the user to control the implantation of the cannula and sensor. The user input device may be, for example, a button on the inserter, a wireless communication device, or some other user-controlled activation device. In some examples, the inserter is configured such that a force applied by the user to the inserter (e.g., a force toward the user's skin) causes the inserter to move the second unit from the disengaged position to the engaged position. The inserter may be configured such that when the inserter moves the second unit from the disengaged position to the engaged position, the first insertion needle moves through the first housing in a first distal direction and the second insertion needle moves through the first housing in a second distal direction to pierce the user's skin and implant the cannula and sensor, respectively.

[0042] The inserter can be configured to align a second electrical connector of the second unit with a first electrical connector of the first unit when the inserter mates with the first unit, such that when the inserter moves the second unit from a disengaged position to an engaged position, the second electrical connector establishes an electrical connection with the first electrical connector. In an example, the inserter is configured to align a second end of the cannula of the second unit with a fluid passage of the first unit when the inserter mates with the first unit, such that when the inserter moves the second unit from a disengaged position to an engaged position, the second end of the cannula is inserted into the fluid passage. The inserter can be configured to align a first channel of the second unit with a first channel of the first unit when the inserter mates with the first unit, such that when the inserter moves the second unit to the engaged position, a first insertion pin can extend through the first channel of the second unit and the first channel of the first unit. The inserter can be configured to align a second channel of the second unit with a second channel of the first unit when the inserter mates with the first unit, such that when the inserter moves the second unit to the engaged position, a second insertion pin can extend through the second channel of the second unit and the second channel of the first unit.

[0043] The inserter can be configured to withdraw a first insertion needle and / or a second insertion needle from the user when the cannula and sensor are implanted. The inserter can withdraw the first insertion needle and / or the second insertion needle while the second housing remains engaged with the first housing. In an example, the inserter is configured to cause initial insertion of the first and second insertion needles in response to a single actuation of the inserter by the user, followed by subsequent withdrawal of the first and second insertion needles. The inserter can be configured to initially cause the first and / or second insertion needles to extend a certain amount in the distal direction to implant the cannula and sensor, and thus subsequently cause the first and / or second insertion needles to withdraw in the proximal direction to be removed from the user's skin. The inserter can be configured to withdraw the first and second insertion needles from the first and second units while the first housing remains engaged with the second housing and the cannula and sensor remain implanted in the user's body.

[0044] Infusion devices can be configured to be positioned close to a user's skin. In one example, a first housing is configured to contact the user's skin. The infusion device can be configured to substantially fix its position on the user to allow for user mobility, for example, during infusion device management and monitoring of therapy being delivered to the user. For example, the infusion device can be configured to allow a degree of user mobility when the infusion device delivers insulin to the user via a cannula and the user's glucose levels are monitored using sensors. The infusion device can be substantially fixed to the user using any suitable arrangement. In some instances, the first and / or second housings of the infusion device include adhesive elements configured to removably secure the infusion device to the user's skin. The infusion device can be used to administer a variety of medications to a user, such as, but not limited to, medications for treating disease, medications for treating pulmonary hypertension, iron chelating agents, analgesics, anticancer treatments, drugs, vitamins, hormones, etc.

[0045] Figure 1 This is a schematic diagram of an infusion device 100 that contacts a user's body 101. In Figure 1, the infusion device 100 is implemented as a fluid delivery device configured to deliver a therapeutic fluid to the user and monitor the user's physiological characteristics. The infusion device 100 includes a cannula 102 and a sensor 104. The cannula 102 is implanted in the body 101 and configured to deliver fluid (e.g., insulin) to the body 101. The sensor 104 (e.g., a glucose sensor) is implanted in the body 101 and configured to detect the user's physiological characteristics (e.g., glucose level).

[0046] The infusion device 100 includes a first unit 106 and a second unit 108. The first unit 106 includes a first housing 110 that mechanically supports one or more components of the first unit 106, such as a fluid reservoir 112 and processing circuitry 114. The second unit 108 includes a second housing 116 that mechanically supports one or more components of the second unit 108, such as a cannula 102 and a sensor 104. The second unit 108 engages (e.g., mechanically engages) the first unit 106 such that the components of the second unit 108 and the components of the first unit 106 operate cooperatively to deliver a therapeutic fluid (e.g., insulin) to the user using the cannula 102 and to monitor the user's physiological characteristics (e.g., glucose levels) using the sensor 104. A portion of the first unit 106 and the second unit 108 are... Figure 1 The image is depicted as being hidden using dashed lines.

[0047] The infusion device 100 may be configured such that a first unit 106 and a second unit 108 substantially define separable units. The infusion device 100 may be configured such that the second unit 108 can be engaged (e.g., mounted thereon) and / or disengaged (e.g., separated from) the first unit 106 by a user's action or some other action. For example, a user may mount the second unit 108 onto the first unit 106 prior to use. In an example, an inserter (not shown) configured to be operated by the user may be used to cause the second unit 108 to engage the first unit 106. The user may separate the second unit 108 and the first unit 106 after use. In an example, the first unit 106 is configured to be positioned on the user (e.g., on the skin 118 of the user's body 101), and the second unit 108 can be installed and removed while the first unit 106 remains positioned on the user. The second unit 108 may be substantially replaceable, such that... Figure 1 The specific second unit 108 depicted herein may be removed by the user and replaced with a replacement second unit (not shown) configured to be similar to and / or substantially the same as the second unit 108.

[0048] The infusion device 100 may be configured such that the second unit 108 disengages and separates from the first unit 106, withdrawing the cannula 102 and sensor 104 from the user's body 101, thereby allowing the cannula 102 and sensor 104 to be discarded after use. The infusion device 100 may be configured such that when a replacement second unit replaces the second unit 108, the cannula and sensor of the replacement second unit are implanted into the body 101. As will be discussed, the second unit 108 may include a first insertion needle (not shown) and a second insertion needle (not shown) configured to implant the cannula 102 and sensor 104 into the body 101 when the second unit 108 engages the first unit 106. The first and second insertion needles may be withdrawn from and substantially displaced from the second unit 108 and the first unit 106 after implantation to improve user comfort, for example, when the infusion device 100 is worn as a portable device.

[0049] The first unit 106 may be configured to restrict movement of the second unit 108 when it engages with the first unit 106. In an example, the second housing 116 is configured to engage (e.g., mechanically engage) the first housing 110 to restrict movement of the second housing 116 relative to the first housing 110. In an example, the second housing 116 or the first housing 110 defines a fixing device 120 configured to restrict movement of the second housing 116 relative to the first housing 110 when the second housing 116 engages with the first housing 110. The fixing device 120 may be, for example, a mechanical structure configured to substantially fix the second housing 116 in a position relative to the first housing 110, a magnetic or electromagnetic device configured to substantially fix the second housing 116 in a position relative to the first housing 110, or some other device configured to restrict movement of the second housing 116 relative to the first housing 110. In some instances, the retaining device 120 is configured to substantially secure the second housing 116 relative to the first housing 110 when the second housing 116 engages the first housing 110 (e.g., by a user). The retaining device 120 may be substantially attached to either the first housing 110 or the second housing 116. That is, when the second unit 108 disengages from and displaces from the first unit 106, the retaining device 120 may be configured to remain attached to either the first unit 106 or the second unit 108.

[0050] In this example, the fixation device 120 is configured to establish at least a first position and at least a second position. In the first position, the fixation device 120 restricts movement of the second housing 116 relative to the first housing 110. In the second position, the fixation device 120 allows substantially independent movement of the second housing 116 relative to the first housing 110 (e.g., allowing the second unit 108 to be removed from the first unit 106). The infusion device 100 may include an input device 122 configured to cause the fixation device 120 to translate from the first position to the second position, or vice versa. The input device 122 may be configured to be actuated by the user as needed to disengage the second unit 108 from the first unit 106, for example, when the user wishes to replace the second unit 108. In this example, the input device 122 is a manual operation button on the first unit 106 and / or the second unit 108, circuitry configured to receive communication (e.g., wireless communication) from a smartphone, tablet, or other device, or configured for use with another device controlled by the user.

[0051] In this example, input device 122 is a multipurpose input device configured to prompt multiple operations of infusion device 100. For example, input device 122 may be configured to cause one or more of the following functions, but not limited to: waking up the processor and / or electronics of infusion device 100; configuring one or more settings of infusion device 100; initiating drug fluid delivery; initiating fluid infusion operation; disabling warnings or alarms generated by infusion device 100; and so on. Instead of buttons, input device 122 may employ a slider mechanism, pin, lever, switch, touch-sensitive element, etc. Input device 108 may be configured to receive communication (e.g., wireless communication) from a device remote from the first housing 110 and / or the second housing 116 to initiate infusion device 100 to perform one or more of the described functions or other functions. Infusion device 100 includes more than one input device 122 (e.g., more than one button) to initiate the various described functions.

[0052] The second housing 116 is configured to engage the first housing 110 (e.g., via a securing device 120) such that components of the first unit 106 and the second unit 108 cooperate to deliver a therapeutic fluid (e.g., insulin) to the user using the cannula 102 and to monitor the user's physiological characteristics (e.g., glucose levels) using the sensor 104. In an example, the first unit 106 includes a fluid reservoir 112 configured to hold fluid and processing circuitry 114 configured to communicate with a sensor. The second unit 108 may include the cannula 102 and the sensor 104. The infusion device 100 may be configured such that when the second housing 116 engages with the first housing 110 (e.g., when the second unit 108 is mounted on the first unit 106), the cannula 102 of the second unit 108 is positioned in fluid communication with the fluid reservoir 112 of the first unit 106 to supply therapeutic fluid. The infusion device 100 can be configured such that when the second housing 116 engages with the first housing 110, the processing circuitry 114 is positioned to be in electrical communication with the sensor 104, allowing the sensor 104 to communicate with the processing circuitry 114. In one example, the infusion device 100 includes: a fluid pump 127 configured to deliver fluid from a fluid reservoir 112 to a cannula 102; and processing circuitry 114 configured to control the operation of the fluid pump 127 (e.g., start or stop pumping) based on a signal from the sensor 104. Therefore, the infusion device 100 is configured such that when the second unit 108 engages with (e.g., is mounted thereon) the first unit 106, components of the first unit 106 and components of the second unit 108 operate cooperatively for the user's therapeutic benefit.

[0053] In this example, sensor 104 is configured to sense the physiological characteristics of a user. In some examples, sensor 104 is a glucose sensor. For instance, sensor 104 may be an electrochemical sensor including glucose oxidase. Glucose oxidase enables sensor 104 to monitor blood glucose levels in diabetic patients or users by performing a reaction between glucose and oxygen. In some examples, sensor 104 includes a working electrode, a counter electrode, and a reference electrode. The working electrode may be coated with glucose oxidase. The reference electrode may be configured to maintain a constant voltage to support the reaction at the working electrode. The counter electrode may be configured to supply current to maintain a set potential on the working electrode. The working electrode, counter electrode, and reference electrode may each be made of a suitable biocompatible metal or metal alloy, such as copper, platinum, platinum-iridium, silver, gold, etc., and may be extruded. When glucose and oxygen diffuse into the glucose oxidase layer, hydrogen peroxide is formed. When a voltage is applied to the working electrode, the hydrogen peroxide present in the metallization layer of the working electrode decomposes and generates electrons. In this example, sensor 104 is configured to cause these electrons to generate an electrical signal, which is transmitted by the working electrode and conveyed to the processing circuitry of the infusion device 100.

[0054] In this example, the cannula 102 is substantially attached to the second unit 108 such that when the second unit 108 disengages from and displaces from the first unit 106 (e.g., due to replacement of the second unit 108 by the user), the separation of the second unit 108 from the first unit 106 causes the cannula 102 to be withdrawn from the user's body 101. The sensor 104 may also be substantially attached to the second unit 108 such that when the second unit 108 disengages from and displaces from the first unit 106, the separation of the second unit 108 from the first unit 106 causes the sensor 104 to be withdrawn from the user's body 101. Therefore, the infusion device 100 can be configured such that disengagement and separation of the second unit 108 from the first unit 106 withdraws the cannula 102 and sensor 104 from the user's body 101, thereby allowing for disposal of the cannula 102 and sensor 104 after use.

[0055] In this example, the infusion device 100 is a portable device. The infusion device 100 may be a wearable device configured for use by a user. In this example, a first housing 110 defines a base surface 111 positioned close to the user's skin 118. The base surface 111 may be configured to serve as a user mounting structure for the infusion device 100. The infusion device 100 may include an adhesive element 113 configured to substantially attach the first housing 110 to the user's body. In this example, the adhesive element 113 may be located on the base surface 111 of the first housing 110, such that the first housing 110 can temporarily adhere to the user's skin 118. The adhesive element 113 may cover substantially all of the base surface 111, or, if desired, may only partially cover the base surface 111. The adhesive element 113 may be, for example, a sheet of double-sided adhesive tape cut to the desired shape and size. In some examples, the infusion device 100 is manufactured using an adhesive liner overlying the adhesive element 113, and the adhesive liner is peeled off to expose the adhesive surface of the adhesive element 113.

[0056] In one example, the base surface 111 defines a first hole 115 forming an opening through the first housing 110. The first hole 115 may be defined to accommodate the passage of a first insertion needle (not shown) and at least a portion of the cannula 102 from a position inside the first housing 110 to a position outside the first housing 110. The first hole 115 may be configured to accommodate the retraction of the first insertion needle from a position outside the first housing 110 to a position inside the first housing 110 (e.g., during withdrawal of the first insertion needle). The base surface 111 may define at least a second hole 117 forming an opening through the first housing 110. The second hole 117 may be defined to accommodate the passage of a second insertion needle (not shown) and at least a portion of the sensor 104 from a position inside the first housing 110 to a position outside the first housing 110. The second hole 117 may be configured to accommodate the retraction of the second insertion needle from a position outside the first housing 110 to a position inside the first housing 110 (e.g., during withdrawal of the second insertion needle).

[0057] Figure 2 A simplified block diagram illustrating an example of an infusion device 100 is provided, wherein a second housing 116 engages with a first housing 110. The infusion device 100 includes a cannula 102, a sensor 104, a first unit 106 defining the first housing 110, a second unit 108 defining the second housing 116, a fluid reservoir 112, and processing circuitry 114. The infusion device 100 is configured to provide fluid from the fluid reservoir 112 to the cannula 102 for delivery of fluid (e.g., insulin) to a user. The infusion device 100 is configured to monitor the user's physiological characteristics using the sensor 104.

[0058] The infusion device 100 is configured to define a first flow path 125, which is configured to provide fluid (e.g., insulin) from a fluid reservoir 112 to a cannula 102 when a second housing 116 engages a first housing 110. The infusion device 100 may include a fluid pump 127 (e.g., an insulin pump) configured to provide fluid to the cannula 102. In one example, the infusion device 100 is configured to define a first flow path 125 from an outlet 129 of the fluid pump 127 through a lumen 128 of the cannula 102. In one example, the infusion device 100 includes a first catheter 131 configured to define the first flow path 125. In one example, the infusion device 100 includes a passage diaphragm 163 configured to provide a fluid connection between the flow path 125 and the cannula 102. The infusion device 100 may be configured such that the cannula 102 punctures the access diaphragm 163 to place the cannula 102 into fluid communication with the flow path 125. The infusion device 100 may be configured to define a second flow path 135 from the fluid reservoir 112 to the suction port 137 of the fluid pump 127. In an example, the infusion device 100 includes a second conduit 139 configured to define the second flow path 135. The fluid pump 127 may include a motor 141 configured to generate pressure to deliver fluid (e.g., via the first flow path 125). In some examples, the fluid pump 127 includes a piston, and the motor 141 is configured to cause translation of the piston. The piston may be configured to cause a force to flow fluid (e.g., insulin) through the flow path 125 when the motor 141 causes translation. In some examples, the piston may be configured to reside in a fluid-filled reservoir. The motor 141 may be a brushless DC motor, a brushed DC motor, or some other type of motor. In this example, motor 141 is powered and / or controlled by processing circuitry 114.

[0059] The infusion device 100 is configured to establish an electrical connection between the sensor 104 and the processing circuitry 114 when the second housing 116 engages with the first housing 110. The infusion device 100 may include a first connector 132 that is in electrical communication with the processing circuitry 114 (e.g., via communication link 134) and a second connector 136 that is in electrical communication with the sensor 104 (e.g., via communication link 138). In one example, the first unit 106 includes the first connector 132, and the second unit 108 includes the second connector 136. The infusion device 100 is configured to establish an electrical connection between the first connector 132 and the second connector 136 when the second housing 116 engages with the first housing 110, such that the sensor 104 is electrically connected to the processing circuitry 114.

[0060] The infusion device 100 may include one or more of the following: a processor device 143; a memory element 145 for storing data, processor-readable program instructions, etc.; a battery 147 or other power source; and a sensor interface 149 configured to receive signals from a sensor 104. In one example, the sensor interface 149 is configured to provide a signal indicating a physiological parameter (e.g., glucose level) to processing circuitry 114. In one example, the sensor interface 104 is configured to measure current from the sensor 104. The sensor 104 may include hardware for implementing the current measurement, such as a potentiometer. In one example, the processor device 143, the sensor interface 104, and / or other components of the infusion device 100 may be configured to perform electrochemical impedance spectroscopy (EIS) measurements to determine, for example, glucose levels. The processor device 143, memory element 145, battery 147, and / or sensor interface 149 may be included on an electronic assembly 151. In one example, the sensor interface 149 is configured to establish an electrical connection between a conductor of the sensor 104 and a conductor of the electronic assembly 151. Electronic assembly 151 (or components of electronic assembly 151) may be electrically coupled to other elements of infusion device 100 as needed to support operation of infusion device 100. Electrical connections to electronic assembly 151 may be direct or indirect, if required. Furthermore, in some embodiments, one or more components of electronic assembly 151 may support wireless data communication.

[0061] In one example, processor device 143 includes processing circuitry 114. In another example, processing circuitry 114 is configured to control the operation of fluid pump 127. For example, processing circuitry 114 may be configured to cause fluid pump 127 to start, continue, and / or stop delivering fluid from fluid reservoir 112 to cannula 102. In another example, sensor 104 is configured to generate a signal indicative of a user's physiological characteristics (e.g., glucose level), and processing circuitry 114 is configured to use the indicative signal to determine the physiological characteristics. In some examples, processing circuitry 114 is configured to control the operation of fluid pump 127 based on the indicative signal reported by sensor 104.

[0062] The first housing 110 of the first unit 106 and the second housing 116 of the second unit 108 are suitably shaped, sized, and configured to house or support the fluid pump 127, the first conduit 131, the second conduit 139, the motor 141, the processor 143, the memory element 145, the battery 147, the sensor interface 149, the electronic assembly 151, and / or other components of the described infusion device 100. In one example, the first unit 106 includes a fluid reservoir 112, processing circuitry 114, the fluid pump 127, the first conduit 131, the first connector 132, the communication link 134, the second conduit 139, the motor 141, the processor 143, the memory element 145, and / or the battery 147. In another example, the second unit 108 includes a cannula 102, a sensor 104, a second connector 136, and / or the communication link 134.

[0063] Figure 3 This is a schematic diagram of an infusion device 100, which includes a cannula 102, a sensor 104, a first unit 106 defining a first housing 110, a second unit 108 defining a second housing 116, a fluid reservoir 112, a processing circuit 114, a fixing device 120, an input device 122, and a fluid pump 127. Figure 3 An example configuration of selected components within the first unit 106 and the second unit 108 is depicted when the second unit 108 engages with the first unit 106. The first housing 110 and the second housing 116 are shown in cross-section having a cutting plane parallel to the page.

[0064] The second unit 108 mechanically supports the cannula 102 such that when the second housing 116 engages with the first housing 110, the cannula 102 substantially establishes fluid communication with the fluid reservoir 112. The cannula 102 may include a first end 124 (“cannula first end 124”), a second end 126 opposite the cannula first end 124 (“cannula second end 126”), and a lumen 128 providing fluid communication between the cannula first end 124 and the cannula second end 126. The cannula first end 124 may be configured to be implanted into the body 101 of use (e.g., using a first insertion needle (not shown)). The second unit 108 mechanically supports a portion of the cannula 102 including the cannula second end 126 such that when the second housing 116 engages with the first housing 110, the cannula second end 126 is inserted into the fluid passage 130 of the first unit 106. The fluid passage 130 is in fluid communication with the fluid reservoir 112 (e.g., via a first conduit 131). Therefore, when the second end 126 of the cannula is inserted into the fluid passage 130, the cannula 102 establishes fluid communication between the fluid reservoir 112 and the first end 124 of the cannula. In this example, the portion of the cannula 102 including the second end 126 is substantially attached to the second unit 108. That is, when the second unit 108 disengages from and displaces from the first unit 106, the cannula 102 can be configured to remain attached to the second unit 108 such that separation of the first unit 106 from the second unit 108 causes the first end 124 of the cannula to be withdrawn from the user's body 101.

[0065] The infusion device 100 is configured to establish communication between a sensor 104 in a second unit 108 and a processing circuitry 114 in a first unit 106 when the second housing 116 engages with the first housing 110. A portion of the sensor 104 may be configured to be implanted into the body 101 in use (e.g., using a second insertion needle (not shown)). In one example, the first unit 106 includes a first connector 132 that is in electrical communication with the processing circuitry 114 (e.g., via a communication link 134), and the second unit 108 includes a second connector 136 that is in electrical communication with the sensor 104 (e.g., via a communication link 138) to establish communication between the sensor 104 and the processing circuitry 114. The infusion device 100 may be configured such that engagement of the second housing 116 with the first housing 110 causes the second connector 136 to establish an electrical connection with the first connector 132, allowing the sensor 104 to provide a signal indicative of the user's physiological characteristics (e.g., glucose level) to the processing circuitry 114.

[0066] The second unit 108 mechanically supports the second connector 136 and the cannula 102, such that engagement of the second housing 116 with the first housing 110 causes the second end 126 of the cannula to be inserted into the fluid passage 130 and causes the second connector 136 to establish an electrical connection with the first connector 132. The infusion device 100 can be configured such that when the retaining device 120 restricts movement of the second housing 116 relative to the first housing 110, the second cannula end 126 is inserted into the fluid passage 130 and the second connector 136 establishes an electrical connection with the first connector 132. In an example, the infusion device 100 is configured such that engagement of the second unit 108 with the first unit 106 causes the infusion device 100 to establish fluid communication between the fluid reservoir 112 and the first end 124 of the cannula and / or an electrical connection between the sensor 104 and the processing circuitry 114. For example, the second unit 108 can be engaged with the first unit 110 by moving the second unit 108 toward the first unit 106 (e.g., in the distal direction D) until the retaining device 120 is used to restrict the movement of the second housing 116 relative to the first housing 110. The retaining device 120 can be used to restrict the movement of the second housing 116 relative to the first housing 110 in the distal direction D, the proximal direction P, or any other direction.

[0067] The infusion device 100 may be configured to cause implantation of the cannula 102 and sensor 104 into the user's body 101 when the second unit 108 engages or is caused to engage with the first unit 106. In an example, as will be discussed, the second unit 108 includes: a first insertion needle configured to cause implantation of the first end 124 of the cannula; and a second insertion needle configured to cause implantation of the sensor 104 when the second unit 108 engages or is caused to engage with the first unit 106. The first and second insertion needles may be configured to move substantially independently of the first unit 106 and the second unit 108 in a distal direction D such that the first and second insertion needles can be withdrawn while the second housing 116 remains engaged with the first housing 100 (e.g., via the fixation device 120) and the first end 124 of the cannula and the sensor 104 remain implanted in the user's body 101.

[0068] The first unit 106 and the second unit 108 may have any shape, size, and / or configuration sufficient to allow the second housing 116 to engage the first unit 116 such that the reservoir 112, which is in fluid communication with the cannula 102 and the sensor 104, is in electrical communication with the processing circuitry 114. In an example, the first housing 110 defines a recess, and a portion of the second housing 116 may be configured to substantially insert into the recess when the second housing 116 engages the first housing 110, but this is not necessary. The first housing 110 and the second housing 116 may be configured in any way such that movement of the first housing 110 relative to the second housing 116 is restricted when the second housing 116 engages the first housing 110. The first housing 110 and the second housing 116 may have any shape, size, and / or configuration sufficient to support (e.g., mechanically support) the components of the first unit 106 and the second unit 108, respectively.

[0069] Figure 4A The infusion device 100 is described, wherein a first unit 106 is positioned close to the user's skin 118 and a second unit 108 is in a disengaged position, such that the second unit 108 is displaced from the first unit 106. The second unit 108 includes a first insertion needle 140 releasably engaged with a cannula 102 and a second insertion needle 142 releasably engaged with a sensor 104. Figure 4B The infusion device 100 is described, wherein the second unit 108 has been moved in the distal direction D to engage the first unit 106. The engagement of the second unit 108 with the first unit 106 has caused the first insertion needle 140 to be inserted into the first end 124 of the cannula and caused the second insertion needle 142 to pass through the skin 118 to be inserted into the sensor 104 and enter the user's body. Figure 4C The infusion device 100 is described in which, when the second unit 108 remains engaged with the first unit 106 and the first end of the cannula 124 and the sensor 104 remain implanted in the user's body, the first insertion needle 140 and the second insertion needle 142 are withdrawn in the proximal direction P.

[0070] The first insertion needle 140 defines a distal end 144 (“first needle distal end 144”), and the second insertion needle 142 defines a distal end 146 (“second needle distal end 146”) configured to pierce the user’s skin 118. As discussed, the infusion device 100 is configured such that when the second unit 108 is displaced and substantially separated from the first unit 106 (e.g. Figure 4A (As depicted), the first unit 106 can approach (e.g., contact) the user's skin 118. The infusion unit 100 can be configured such that when the second unit 108 moves in the distal direction D and engages with the first unit 106 (e.g., ... Figure 4BAs depicted in the diagram, movement of the second unit 108 toward the first unit 106 causes the first insertion needle 140 and the second insertion needle 142 to extend through the first unit 106 and pierce the user's skin 118, thereby causing implantation of the cannula 102 (e.g., the first end 124 of the cannula) and the sensor 104. When the first unit 106 engages with the second unit 108, the second unit 108 causes the second end 126 of the cannula to be inserted into the fluid passage 130, so that the fluid reservoir 112 is in fluid communication with the first end 124 of the cannula (e.g., via the first catheter 131), and causes the second connector 136 to be electrically connected to the first connector 132, so that the processing circuit 114 is electrically connected to the sensor 104. The infusion device 100 may be configured such that when the cannula 102 and the sensor 104 remain implanted in the user's body and the second unit 108 remains engaged with the first unit 106 (e.g., the cannula 102 and the sensor 104 remain implanted in the user's body and the second unit 108 remains engaged with the first unit 106 (e.g., the cannula 102 and the sensor 104 remain implanted in the user's body and the second unit 108 remains engaged with the first unit 106), Figure 4C As depicted in the illustration, the first insertion needle 140 and the second insertion needle 142 can be withdrawn proximally and separated from the first unit 106 and the second unit 108. The infusion device 100 remains configured to deliver fluid (e.g., insulin) to the user using the cannula 102 and to monitor the user's physiological characteristics (e.g., glucose levels) using the sensor 104 when the first insertion needle 140 and the second insertion needle 142 are withdrawn and separated from the first unit 106 and the second unit 108.

[0071] The first unit 106 is configured such that the first insertion pin 140 is translatable relative to the first unit 106 (e.g., in the distal direction D and / or the proximal direction P). In one example, the first unit 106 defines a first channel 148 (“first unit first channel 148”) extending through the first housing 110. In one example, the first unit 106 includes a facing surface 150 (“first facing surface 150”) configured to substantially face the second unit 108, and the first unit first channel 148 defines a passage through the first housing 110 from the first facing surface 150 to the first hole 115. In one example, the second unit 108 defines a facing surface 152 (“second facing surface 152”), and the first facing surface 150 is configured to substantially face the second facing surface 152.

[0072] The first channel 148 of the first unit is configured to accommodate the passage of a portion of the first insertion needle 140 and the cannula 102 when the second unit 108 is displaced toward the first unit 106 in the distal direction D (e.g., when the second facing surface 152 moves toward the first facing surface 150). In some instances, portions of the first insertion needle 140 and the cannula 102 are configured to extend from the second unit 108 and through the first channel 148 of the first unit when the second unit 108 is displaced toward the first unit 106 in the distal direction D. Portions of the first insertion needle 140 and the cannula 102 are configured to translate relative to the first unit 106 in the distal direction D through the first channel 148 of the first unit, such that when the second unit 108 is displaced in the distal direction D to engage the second unit 108, the first insertion needle 140 and the cannula 102 can extend through the first channel 148 of the first unit to pierce the user's skin 118.

[0073] In one example, the infusion device 100 includes a needle holder 156 configured to cause a first insertion needle 140 to translate through a first unit first channel 148 in a distal direction D or a proximal direction P. In another example, the needle holder 156 is configured to restrict movement of the first insertion needle 140 relative to the needle holder 156, such that movement of the needle holder 156 (e.g., in the distal direction D or the proximal direction P) causes a corresponding movement of the first insertion needle 140 through the first unit first channel 148. In another example, the needle holder 156 is configured to receive a force in the distal direction D and transmit at least a portion of the force in the distal direction D to the first insertion needle 140 such that, for example, the first insertion needle 140 moves distally through the first unit first channel 148. The needle holder 156 may be configured to receive a force in the proximal direction P and transmit at least a portion of the force in the proximal direction P to the first insertion needle 140 such that, for example, the first insertion needle 140 moves proximally through the first channel 148 of the first unit. The needle holder 156 may be configured to cause movement of the first insertion needle 140 in any suitable manner. In an example, the first insertion needle 140 is substantially attached to the needle holder 156 using fasteners, clamps, an interference fit with the needle holder 156, or some other suitable arrangement sufficient to allow the needle holder 156 to transmit force to the first insertion needle 140.

[0074] The first insertion pin 140 is translatable relative to the first housing 110 and / or the second housing 116 in a distal direction and / or proximal direction. In an example, the distal direction is the direction that would cause the distal end 144 of the first pin to move away from the first housing 110 when a portion of the first insertion pin 140 is within the first channel 148 of the first unit. The proximal direction is the direction that would cause the distal end 144 of the first pin to move toward the first housing 110 when a portion of the first insertion pin 140 is within the first channel 148 of the first unit. The first insertion pin 140 is translatable in either the distal or proximal direction, regardless of whether a portion of the first insertion pin 140 is within the first channel 148 of the first unit, provided that if a portion of the first insertion pin 144 is within the first channel 148 of the first unit, then the distal and / or proximal directions will cause movement of the distal end 144 of the first pin as described.

[0075] The first unit 106 is configured such that the second insertion pin 142 is translatable relative to the first unit 106 (e.g., in the distal direction D and / or the proximal direction P). In one example, the first unit 106 defines a second channel 154 (“first unit second channel 154”) extending through the first housing 110. In one example, the first unit second channel 154 defines a passage through the first housing 110 from the first facing surface 150 to the second hole 117.

[0076] The first unit's second channel 154 is configured to accommodate the passage of at least a portion of the second insertion needle 142 and the sensor 104 when the second unit 108 is displaced toward the first unit 106 in the distal direction D (e.g., when the second facing surface 152 moves toward the first facing surface 150). In some instances, the second insertion needle 142 and the sensor 104 are configured to extend from the second unit 108 and through the first unit's second channel 154 when the second unit 108 is displaced toward the first unit 106 in the distal direction D. The second insertion needle 142 and the sensor 104 are configured to translate relative to the first unit 106 in the distal direction D through the first unit's second channel 154, such that when the second unit 108 is displaced in the distal direction D to engage the second unit 108, the second insertion needle 142 and the sensor 104 can extend through the first unit's second channel 106 to pierce the user's skin 118.

[0077] In one example, the needle holder 156 is configured to cause the second insertion needle 142 to translate through the second channel 154 of the first unit in a distal direction D or a proximal direction P. In another example, the needle holder 156 is configured to restrict movement of the second insertion needle 142 relative to the needle holder 156, such that movement of the needle holder 156 (e.g., in the distal direction D or the proximal direction P) causes a corresponding movement of the second insertion needle 142 through the second channel 154 of the first unit. In another example, the needle holder 156 is configured to receive a force in the distal direction D and transmit at least a portion of the force in the distal direction D to the second insertion needle 142 such that, for example, the second insertion needle 142 moves distally through the second channel 154 of the first unit. The needle holder 156 may also be configured to receive a force in the proximal direction P and transmit at least a portion of the force in the proximal direction P to the second insertion needle 142 such that, for example, the second insertion needle 142 moves proximally through the second channel 154 of the first unit. In this example, the second insertion needle 142 is substantially attached to the needle holder 156 using fasteners, clamps, an interference fit with the needle holder 156, or some other suitable arrangement that allows the needle holder 156 to transmit force to the second insertion needle 142.

[0078] The second insertion pin 142 can be translated relative to the first housing 110 and / or the second housing 116 in the distal direction and / or proximal direction. In an example, the distal direction is the direction that would cause the distal end 146 of the second pin to move away from the first housing 110 when a portion of the second insertion pin 142 is within the second channel 154 of the first unit. The proximal direction is the direction that would cause the distal end 146 of the second pin to move toward the first housing 110 when a portion of the second insertion pin 142 is within the second channel 154 of the first unit. The second insertion pin 142 can be translated in either the distal or proximal direction, regardless of whether a portion of the second insertion pin 142 is within the second channel 154 of the first unit, provided that if a portion of the second insertion pin 142 is within the second channel 154 of the first unit, then the distal and / or proximal directions will cause movement of the distal end 146 of the second pin as described. The distal direction can be similar to or substantially the same as the distal direction of the first pin. The proximal direction of the second stitch can be similar to or basically the same as that of the first stitch.

[0079] The infusion device 100 can be configured such that when the second unit 108 moves toward the first unit 106 in the distal direction D (e.g., when the infusion device 100 moves from...), Figure 4A configuration conversion Figure 4BIn this configuration, the first insertion needle 140 and the second insertion needle 142 pierce the user's skin 118 substantially simultaneously. The infusion device 100 can be configured such that the first insertion needle 140 and the second insertion needle 142 pierce the skin 118 substantially simultaneously to, for example, limit user discomfort that may be caused by insertions separated by time increments that are identifiable to the user. In an example, the needle holder 156 is configured to cause the first insertion needle 140 to translate substantially simultaneously through the first channel 148 of the first unit and the second insertion needle 142 through the second channel 154 of the first unit. The needle holder 156 can be configured to translate the first insertion needle 140 and the second insertion needle 142 substantially simultaneously such that the distal ends 144 and 146 of the first needle pierce the skin 118 substantially simultaneously.

[0080] In some instances, the needle holder 156 is configured to apply a force to the second unit 108 in the distal direction D, causing the second unit 108 to move distally toward the first unit 106. In some instances, the needle holder 156 is configured to receive a force in the distal direction D (e.g., from the inserter (not shown)) and transmit a portion of the force to the second unit 108, causing the second unit 108 to move distally toward the first unit 106. The infusion device 100 may be configured such that when the needle holder 156 receives a force in the distal direction D, the needle holder 156 transmits a portion of the force to the second housing 116, causing the second unit 108 to contact the first unit 106 (e.g., causing the second facing surface 152 to contact the first facing surface 150), and causing the second housing 116 to engage the first housing 110 (e.g., as shown in the image). Figure 4B (As depicted in the text). In this example, the needle holder 156 is configured to apply a distal force to the second unit 108 on a support surface 158 opposite to the second facing surface 152 of the second unit 108.

[0081] In this example, the second unit 108 is configured such that the first insertion pin 140 is translatable relative to the second unit 108 (e.g., in the distal direction D and / or the proximal direction P) to allow the first insertion pin 140 to be withdrawn from the second unit 108, for example, when the second unit 108 is engaged with the first unit 106. Figure 4C (As depicted in the illustration). In one example, the second unit 108 defines a first channel 160 (“second unit first channel 160”) extending through the second housing 116. In one example, the second unit first channel 160 defines a channel through the second housing 116 between the second facing surface 152 and the support surface 158. The second unit first channel 160 can be configured to accommodate the passage of at least the first insertion pin 140 when the first insertion pin 140 is displaced away from the second unit 108 in the proximal direction P (e.g., Figure 4C(As depicted in the illustration). In some instances, portions of the first insertion needle 140 and the cannula 102 are configured to extend from the second unit 108 through the second unit first channel 160 as the second unit 108 is displaced toward the first unit 106 in the distal direction D. The first insertion needle 140 may be configured to translate relative to the second unit 108 through the second unit first channel 160 in the proximal direction P, such that the first insertion needle 140 can be withdrawn from the second unit 108 after the cannula 102 has been implanted.

[0082] The needle holder 156 can be configured to cause the first insertion needle 140 to translate proximally through the first channel 160 of the second unit when the needle holder 156 translates away from the second unit 108 in the proximal direction P. In an example, the needle holder 156 is configured to receive a force in the proximal direction P and transmit at least a portion of the force in the proximal direction P to the first insertion needle 140 such that, for example, the first insertion needle 140 moves proximally through the first channel 160 of the second unit. In an example, the needle holder 156 is configured to receive a force in the proximal direction P (e.g., from an inserter (not shown)) and transmit a portion of the force to the first insertion needle 140 such that the first insertion needle 140 is displaced from the second unit 108 in the proximal direction P.

[0083] In this example, the second unit 108 is configured such that the second insertion pin 142 is translatable relative to the second unit 108 (e.g., in the distal direction D and / or the proximal direction P) to allow the second insertion pin 142 to be withdrawn from the second unit 108, for example, when the second unit 108 is engaged with the first unit 106. Figure 4C (As depicted in the illustration). In one example, the second unit 108 defines a second channel 162 (“second unit second channel 162”) extending through the second housing 116. In one example, the second unit second channel 162 defines a channel through the second housing 116 between the second facing surface 152 and the support surface 158. The second unit second channel 162 can be configured to accommodate the passage of at least the second insertion pin 142 when the second insertion pin 142 is displaced away from the second unit 108 in the proximal direction P (e.g., as depicted in the illustration). Figure 4C (As depicted in the illustration). In some instances, a portion of the second insertion needle 142 and the sensor 104 is configured to extend from the second unit 108 through the second channel 162 of the second unit 108 as the second unit 108 is displaced toward the first unit 106 in the distal direction D. The second insertion needle 142 may be configured to translate relative to the second unit 108 through the second channel 162 of the second unit in the proximal direction P, such that the second insertion needle 142 can be withdrawn from the second unit 108 after the sensor 104 has been implanted.

[0084] The needle holder 156 can be configured to cause the second insertion needle 142 to translate proximally through the second channel 162 of the second unit when the needle holder 156 translates away from the second unit 108 in the proximal direction P. In an example, the needle holder 156 is configured to receive a force in the proximal direction P and transmit at least a portion of the force in the proximal direction P to the second insertion needle 142 such that, for example, the second insertion needle 142 moves proximally through the second channel 162 of the second unit. In an example, the needle holder 156 is configured to receive a force in the proximal direction P (e.g., from an inserter (not shown)) and transmit a portion of the force to the second insertion needle 142 such that the second insertion needle 142 is displaced from the second unit 108 in the proximal direction P.

[0085] The infusion device 100 can be configured such that, substantially simultaneously with the movement of the needle holder 156 away from the second unit 108 in the proximal direction P (e.g., when the infusion device 100 is removed from the second unit 108), the infusion device 100 is removed from the second unit 108. Figure 4B configuration conversion Figure 4C (In the configuration) the first insertion needle 140 and the second insertion needle 142 are withdrawn from the user's skin 118. The infusion device 100 may be configured such that the first insertion needle 140 and the second insertion needle 142 are withdrawn from the skin 118 substantially simultaneously to, for example, limit user discomfort that may be caused by withdrawals separated by time increments that are perceptible to the user. In an example, the needle holder 156 is configured to cause the first insertion needle 140 to translate substantially simultaneously through the first channel 160 of the second unit and the second insertion needle 142 through the second channel 162 of the second unit. The needle holder 156 may be configured to translate the first insertion needle 140 and the second insertion needle 142 substantially simultaneously such that the distal ends 144 and 146 of the first needle are withdrawn substantially simultaneously from the skin 118.

[0086] In this example, the infusion device 100 is configured to fluidly isolate the fluid passage 130 from portions of the infusion device 100 to substantially prevent adverse effects that could result from contact with fluid in the fluid reservoir 112. Portions of the infusion device may include, but are not limited to, other components such as the first connector 132, the second connector 136, the first facing surface 150, the second facing surface 152, and / or the first unit 106 and / or the second unit 108. In this example, the infusion device 100 includes a passage diaphragm 163 configured to fluidly isolate portions of the infusion device 100 from the fluid passage 130. The infusion device 100 may be configured such that when the second housing 116 engages the first housing 110, the second end 126 of the cannula pierces the passage diaphragm 163 to place the second end 126 in fluid communication with the fluid passage 130. The access diaphragm 163 may be made of a self-sealing material such that the access diaphragm 163 is closed substantially around the second end 126 of the cannula to substantially maintain fluid isolation between a portion of the infusion device 100 and the fluid passage 130.

[0087] In this example, the infusion device 100 is configured to fluidly isolate the second unit first channel 160 from a portion of the infusion device 100 to substantially prevent adverse effects that could result from contact with fluid flowing through the cannula 102. The portion of the infusion device may include, but is not limited to, other components such as the first connector 132, the second connector 136, the first facing surface 150, the second facing surface 152, and / or the first unit 106 and / or the second unit 108. In this example, the infusion device 100 includes a second diaphragm 165 configured to fluidly isolate a portion of the infusion device 100 from the second unit first channel 160. The infusion device 100 may be configured such that when the first insertion needle 140 extends through the second unit first channel 160, the first insertion needle 140 extends through the second diaphragm 165. The second diaphragm 165 may be made of a self-sealing material such that the second diaphragm 165 closes substantially around the first insertion needle 140 to substantially maintain fluid isolation between the portion of the infusion device 100 and the second unit first channel 160. The second diaphragm 165 may be configured to self-seal when the first insertion needle 140 is withdrawn through the second diaphragm 165 (e.g., withdrawn in the proximal direction P) to maintain fluid isolation between a portion of the infusion device 100 and the first channel 160 of the second unit when the first insertion needle 140 is displaced from the second unit 108.

[0088] Figure 5 This describes an example infusion device configured such that one or more components of a first unit 106 are substantially aligned with one or more components of a second unit 108, such that the infusion device is configured to deliver therapeutic fluid and monitor the user's physiological characteristics when the second unit 108 engages with the first unit 106. For example, a second housing 116 may define an axis A1, and the second unit 108 may be configured to translate a first insertion needle 140 and a first cannula end 124 along axis A1 when the second unit 108 is translated toward the first unit 106. In this example, the second unit 108 is configured such that axis A1 passes through a first unit first channel 148 of the first unit 106, such that movement of the second unit 108 toward the first unit 106 in a distal direction D causes the first insertion needle 140 and the first cannula end 124 to extend through the first unit first channel 148. In this example, the second housing 116 defines and is aligned with axis A2 and configured to translate the second insertion pin 142 and sensor 104 along axis A2 when the second unit 108 translates toward the first unit 106. The second unit 108 may be configured such that axis A2 passes through a first unit second channel 154 of the first unit 106, such that movement of the second unit 108 toward the first unit 106 in the distal direction D causes the second insertion pin 142 and sensor 104 to extend through the first unit second channel 154.

[0089] In this example, the second housing 116 defines axes A1 and A2 such that when axis A1 passes through the first channel 148 of the first unit, axis A2 passes through the second channel 154 of the first unit. Therefore, the second unit 108 can be configured to translate the first insertion pin 140 and the first end 124 of the cannula through the first channel 148 of the first unit along axis A1, and the second insertion pin 142 and the sensor 104 through the second channel 154 of the first unit along axis A2, when the second unit 108 is translated toward the first unit 106 in the distal direction D. The second unit 108 can be configured to be in a disengaged position (e.g., displaced from the first unit 106) when the second unit 108 is in a disengaged position (e.g., displaced from the first unit 106). Figure 4A , Figure 5 When the first insertion needle 140 and the first end 124 of the cannula are substantially aligned with the first channel 148 of the first unit and the second insertion needle 142 and the sensor 104 are substantially aligned with the second channel 154 of the first unit, the engagement of the second housing 116 and the first housing 110 causes the first insertion needle 140 and the first end 124 of the cannula to pass through the first channel 148 of the first unit and causes the second insertion needle 142 and the sensor 104 to pass through the second channel 154 of the first unit.

[0090] In this example, the second housing 116 defines an axis A3. The second unit 108 may be configured to translate the second end 126 of the cannula along axis A3 when the second unit 108 translates toward the first unit 106. In this example, the second unit 108 is configured such that axis A3 passes through the fluid passage 130 of the first unit 106, such that movement of the second unit 108 toward the first unit 106 in the distal direction D causes the second end 126 of the cannula to be inserted into the fluid passage 130 and establishes fluid communication between the fluid reservoir 112 and the first end 124 of the cannula (e.g., via the first conduit 131). The second housing 116 may define axis A3 such that when axis A3 passes through the fluid passage 130, axis A1 passes through the first channel 148 of the first unit and / or axis A2 passes through the second channel 154 of the first unit. Therefore, the second unit 108 can be configured to substantially align the second end 126 of the cannula with the fluid passage 130, substantially align the first insertion needle 140 and the first end 124 of the cannula with the first channel 148 of the first unit, and / or substantially align the second insertion needle 142 and the sensor 104 with the second channel 154 of the first unit. The second unit 108 can be configured such that when the second unit 108 is in the disengaged position (e.g., displaced from the first unit 106), Figure 4A , Figure 5 When the second housing 116 engages with the first housing 110, the second cannula end 126 is inserted into the fluid passage 130, causing the first insertion needle 140 and the first end of the cannula 124 to pass through the first channel 148 of the first unit, and / or causing the second insertion needle 142 and the sensor 104 to pass through the second channel 154 of the first unit.

[0091] In this example, the second housing 116 defines axis A4. The second unit 108 may be configured to translate the second connector 136 along axis A4 when the second unit 108 translates toward the first unit 106. In this example, the second unit 108 is configured such that axis A4 passes through the first connector 132 of the first unit 106, such that movement of the second unit 108 toward the first unit 106 in the distal direction D causes the second connector 136 to contact the first connector 132 and establish electrical communication between the sensor 104 and the processing circuit 114. The second housing 116 may define axis A4 such that when axis A4 passes through the first connector 132, axis A1 passes through the first channel 148 of the first unit, axis A2 passes through the second channel 154 of the first unit, and / or axis A3 passes through the fluid passage 130. Therefore, the second unit 108 can be configured such that the second connector 136 is substantially aligned with the first connector 132, the first insertion pin 140 and the first end 124 of the cannula are substantially aligned with the first channel 148 of the first unit, the second insertion pin 142 and the sensor 104 are substantially aligned with the second channel 154 of the first unit, and / or the second end 126 of the cannula is substantially aligned with the fluid passage 130. The second unit 108 can be configured such that when the second unit 108 is in the disengaged position (e.g., displaced from the first unit 106), Figure 4A , Figure 5 When the second housing 116 engages with the first housing 110, the second connector 136 contacts the first connector 132, causing the first insertion pin 140 and the first end 124 of the cannula to pass through the first channel 148 of the first unit, causing the second insertion pin 142 and the sensor 104 to pass through the second channel 154 of the first unit, and / or causing the second end 126 of the cannula to be inserted into the fluid passage 130.

[0092] Figure 6A and Figure 6B The inserter 170 is described as being configured to cause the second housing 116 of the second unit 108 to engage the first housing 110 of the first unit 106. The inserter 170 is configured to hold the second unit 108 in a disengaged position in which the second unit 108 has been displaced from the first unit 106 (e.g., Figure 4A Insertor 170 is configured to cause the second unit 108 to move to an engagement position in which the second housing 116 engages with the first housing 110 (e.g., Figure 4B The inserter 170 is configured to induce implantation of the cannula 102 and sensor 104 using the first insertion needle 140 and the second insertion needle 142, respectively. The inserter 170 can be configured to withdraw the first insertion needle 140 and the second insertion needle 142 after implantation of the cannula 102 and sensor 104 (e.g., Figure 4C ). Figure 6A and Figure 6BRefer to the example inserter 170 for the xyz axis shown in the diagram. The z-axis advances to... Figure 6A Outside of the page, and the y-axis advances to Figure 6B On the page, inserter 170 is depicted as holding the second unit 108 in place. Figure 6A and Figure 6B The disengagement position in the middle, where the second unit 108 is hidden and in Figure 6A The dotted line in the middle is used for illustration.

[0093] Insertor 170 may be configured to allow a user to engage insertor 170 with second housing 116 and first housing 110 to induce implantation of cannula 102 and sensor 104. In one example, insertor 170 includes a plunger 172 configured for user manipulation to induce implantation. The plunger 172 may engage with insertion member 174, which is configured to align second unit 108 and first unit 106 such that when insertor 170 causes second housing 116 to engage with first housing 110, components of first unit 106 and second unit 108 cooperatively operate to deliver a therapeutic fluid (e.g., insulin) to the user using cannula 102 and to monitor the user's physiological characteristics (e.g., glucose level) using sensor 104. In one example, insertor 170 is configured such that a user can cause plunger 172 to translate distally relative to insertion member 174 in a distal direction D to initiate implantation of cannula 102 and sensor 104.

[0094] Insertor 170 can be configured to engage with first unit 106 when insertor 170 holds second unit 108 in the disengaged position. In an example, insertor 170 (e.g., insertion member 174) includes one or more alignment members 176, said alignment members 176 including members 175 and 177 configured to engage with first unit 106. Alignment members 176 can be configured such that when insertor 170 engages with first unit 106, insertor 170 causes axis A1 ( Figure 5 A1 passes through the first insertion pin 140 and the first channel 148 of the first unit, A2 passes through the second insertion pin 142 and the second channel 154 of the first unit, A3 passes through the second end 126 of the cannula and the fluid passage 130, and / or A4 passes through the second connector 136 and the first connector 132.

[0095] Figure 7 Example 106 is illustrated, which includes a first housing 110, a first channel 148 of the first unit, a second channel 154 of the first unit, a fluid passage 130, and a first connector 132. Figure 6A , Figure 6BThe xyz axes and the y-axis extending beyond the page are included together for reference. In an example, the first housing 110 defines one or more alignment members 178, including members 179 and 180. In an example, the first housing 110 defines alignment members 178 surrounding an outer periphery 182 of the first housing 110. In an example, the insert 170 is configured to engage with the first unit 106 by causing the alignment members 176 of the insert 170 to engage the alignment members 178 of the first unit 106. For example, one or more of the alignment members 176 may be configured to be inserted into a protrusion defined by one or more of the alignment members 178. In an example, one or more of the alignment members 176 may be configured to be inserted into a protrusion in one or more of the alignment members 178.

[0096] Insert 170 may be configured to translate relative to first unit 106 (e.g., in the distal direction D) to induce engagement between alignment member 176 and alignment member 178. For example, insert 170 may be configured to translate in the distal direction D such that when alignment member 176 engages alignment member 178, insert 170 (e.g., insert member 174) substantially surrounds the outer periphery 182 of first unit 106. Insert 170 may be configured such that when alignment member 176 engages alignment member 178, insert 170 causes axis A1 ( Figure 5 A1 passes through the first insertion needle 140 and the first channel 148 of the first unit, A2 passes through the second insertion needle 142 and the second channel 154 of the first unit, A3 passes through the second end 126 of the cannula and the fluid passage 130, and / or A4 passes through the second connector 136 and the first connector 132. Therefore, the insert 170 can be configured such that the second unit 108 and the first unit 106 are substantially aligned, such that when the inserter 170 causes the second housing 116 to engage with the first housing 110, the components of the first unit 106 and the second unit 108 cooperate to deliver a therapeutic fluid (e.g., insulin) to the user using the cannula 102 and to monitor the user's physiological characteristics (e.g., glucose levels) using the sensor 104.

[0097] Figure 8A This describes the cross-section of the insert 170, which has a cutting plane parallel to the page. Figure 6A , Figure 6B and Figure 7 The xyz axes and the z-axis extending beyond the page are included together for reference. Insert 170 includes an insertion member 174 and holds the second unit 108 in a disengaged position relative to the first unit 106. Insert member 174 engages with the first unit 106 such that axis A1( Figure 5A1 passes through the first insertion pin 140 and the first channel 148 of the first unit, A2 passes through the second insertion pin 142 and the second channel 154 of the first unit, A3 passes through the second end 126 of the cannula and the fluid passage 130, and A4 passes through the second connector 136 and the first connector 132.

[0098] Insert 170 includes a loading member 184 configured to compress insert spring 186. Loading member 184 may be configured to compress insert spring 186 when plunger 172 applies a force (e.g., in the distal direction D) to loading member 184. In an example, loading member 184 is configured to translate relative to insert member 174 when plunger 172 translates relative to member 174 to cause compression of insert spring 186. Loading member 184 may be configured to apply a force (e.g., in the distal direction D) to insert spring 186 to cause compression of insert spring 186.

[0099] In one example, insert 170 includes a discharge member 188 configured to apply a force to insert spring 186 opposite to the force applied by loading member 184 when loading member 184 compresses insert spring 186. In another example, insert spring 186 is configured to compress substantially between loading member 184 and discharge member 188. When loading member 184 translates relative to insert member 174 (e.g., under the influence of plunger 172), loading member 188 can be configured to remain substantially stationary relative to insert member 174, such that relative movement between loading member 184 and discharge member 188 causes compression of insert spring 186. In some examples, inserter 170 includes a release device 190 configured to maintain discharge member 188 substantially stationary relative to insert member 174 when loading member 184 translates relative to insert member 174.

[0100] As an example, Figure 8B The insert 170 is described, wherein the plunger 172 has been translated distally relative to the insert member 174 to cause compression of the insert spring 186. A compression insert spring is provided. The translation of the plunger 172 has caused the loading member 184 to translate relative to the insert member 174. The insert spring 186 has been compressed as the loading member 184 translates relative to the insert member 174 because the discharge member 184 remains substantially stationary relative to the insert member 174 (e.g., due to the release device 190). In the example, and as... Figure 8A and Figure 8B As depicted, the first unit 106 can be configured to remain substantially stationary relative to the discharge member 188 when the loading member 184 translates relative to the discharge member 188.

[0101] The discharge member 188 may be configured to apply a force to the second unit 108 to cause the second unit 108 to move relative to the first unit 106 and relative to the insertion member 174. In one example, the insertion spring 186 is configured to apply a spring force to the discharge member 188 to cause movement. The insertion member 170 may be configured such that when the loading member 184 translates a certain amount relative to the insertion member 174 (causing loading of the insertion spring 186), the insertion member 170 causes the release device 190 to disengage from the discharge member 188, allowing the insertion spring 186 to cause movement of the discharge member 188 relative to the insertion member 174. This movement of the discharge member 188 relative to the insertion member 174 may cause the discharge member 188 to apply a force to the second unit 108 (e.g., in the distal direction D), thereby causing the second unit 108 to move toward the first unit 106.

[0102] Figure 8C The insert 170 has caused the release device 190 to disengage from the discharge member 188. The insert spring 186 has applied a force to the discharge member 188 (e.g., in the distal direction D), thereby causing movement of the discharge member 188 (e.g., in the distal direction D). This movement of the discharge member 188 has caused it to apply a force to the second unit 108, thereby causing the second unit 108 to move toward the first unit 106 (e.g., in the distal direction D).

[0103] exist Figure 8C In this process, the movement of the second unit 108 toward the first unit 106 causes the second housing 116 to engage with the first housing 110, such that the first housing 110 substantially restricts the movement of the second housing 116 relative to the first housing 110. For example, the movement of the second unit 108 toward the first unit 106 can cause the fixing device 120 ( Figure 1 , Figure 3 The second housing 116 is essentially fixed in position relative to the first housing 110. Furthermore, the movement of the second unit 108 toward the first unit 106 has caused the first insertion pin 140 and the first end 124 of the cannula to extend through the first channel 148 of the first unit. Figures 4A to 4C And the second insertion pin 142 and sensor 104 extend through the second channel 154 of the first unit. Figures 4A to 4C The extension of the first insertion needle 140 and the second insertion needle 142 causes the first end 124 of the cannula and the sensor 104 to be implanted into the user's body.

[0104] In addition, Figure 8C In the middle, the movement of the second unit 108 toward the first unit 106 has caused the second end 126 of the cannula ( Figure 6B Insert fluid passage 130 ( Figure 7 ) within the fluid reservoir 112 ( Figure 3 , Figures 4A to 4C) and the first end of the cannula 124 ( Figure 6B A fluid connection is established between them. The movement of the second unit 108 toward the first unit 106 has caused the second connector 136 ( Figure 6B ) and the first connector 132 ( Figure 7 Electrical connection to processing circuit 114 ( Figure 3 , Figures 4A to 4C An electrical connection is established between the sensor 104 and the sensor 104.

[0105] In the example, and as Figure 8C As depicted, the needle holder 156 can be configured to remain substantially stationary relative to the second unit 108 when the discharge member 188 causes movement of the second unit 108. In an example, the inserter 170 includes a release device 192 configured to maintain the needle holder 156 substantially stationary relative to the second unit 108 when the discharge member 188 causes the second unit 108 to move toward the first unit 106.

[0106] In one example, insert 170 includes a withdrawal spring 194 configured to cause the first insertion pin 140 and the second insertion pin 142 to move relative to the second unit 108 (and relative to the first unit 106 when the second housing 116 engages with the first housing 110). In another example, the withdrawal spring is configured to apply a force (e.g., in the proximal direction P) to the first insertion pin 140 and the second insertion pin 142 to induce movement. Insert 170 may be configured to cause the first insertion pin 140 to move relative to the second unit 108 through the first channel 160 of the second unit. Figures 4A to 4C The insert 170 can be configured to cause the second insert pin 142 to move relative to the second unit 108 through the second channel 162 of the second unit. Figures 4A to 4C In some instances, the withdrawal spring 194 is configured to apply force to the needle holder 156 to cause movement of the needle holder 156 relative to the second unit 108, and the needle holder 156 is configured to transmit at least a portion of the force to the first insertion needle 140 and the second insertion needle 142 to cause movement of the first insertion needle 140 and the second insertion needle 142 relative to the second unit 108.

[0107] Figure 8DThe insert 170 is described, which has caused the release device 192 to disengage from the needle holder 156, allowing the first insert needle 140 and the second insert needle 142 to move proximally relative to the second unit 108. The withdrawal spring 194 has been released to apply a force (e.g., in the proximal direction P) to the first insert needle 140 and the second insert needle 142 to induce movement. In this example, the withdrawal spring 194 applies a force to the needle holder 156 in the proximal direction P, resulting in movement of the needle holder 156 in the proximal direction, and this movement of the needle holder 156 causes movement of the first insert needle 140 and the second insert needle 142 relative to the second unit 108.

[0108] Release device 190 may be configured to engage sufficiently to keep discharge member 188 substantially stationary relative to insertion member 174 during translation of loading member 184 relative to insertion member 174, and to disengage sufficiently to allow insertion spring 186 to cause discharge member 188 to move relative to insertion member 174. Release device 192 may be configured to engage sufficiently to keep needle holder 156 substantially stationary relative to second unit 108 during movement of second unit 108 toward first unit 106 caused by discharge member 188, and to disengage sufficiently to allow first insertion needle 140 and second insertion needle 142 to translate proximally relative to second unit 108. Release devices 190, 192 may include, for example: a mechanical switch configured to be actuated by a portion or structure of inserter 170; a magnetic switch configured to be actuated based on the position of a portion or structure of inserter 170; an actuation device configured to be actuated by a position sensor included in inserter 170; a specific structure of inserter 170; and / or a means configured to be actuated using other arrangements.

[0109] As discussed, the first insertion needle 140 is configured to implant the first end 124 of the cannula into the user's body, and is configured to release the first end 124 of the cannula when the first insertion needle 140 is withdrawn, such that the first insertion needle 140 can be displaced from the second unit 108 while the first end 124 of the cannula remains implanted in the user's body. The second insertion needle 142 is configured to implant the sensor 104 into the user's body, and is configured to release the sensor 104 when the second insertion needle 142 is withdrawn, such that the second insertion needle 142 can be displaced from the second unit 108 while the sensor 104 remains implanted in the user's body.

[0110] In one example, the first insertion needle 140 is configured to engage the cannula 102 such that, when the first insertion needle 140 translates in a first direction, the first end 124 of the cannula translates toward the user in that first direction (e.g., in the distal direction D). The first insertion needle 140 may be configured to apply a force to the cannula 102 in the first direction to cause translation of the first end 124 of the cannula. In another example, the first insertion needle 140 and / or the cannula 102 include a first structural feature configured to cause the first insertion needle 140 to apply a force to the cannula 102 in the first direction. The first insertion needle 140 may be configured to disengage (e.g., release) from the cannula 102 when the first insertion needle 140 is subsequently withdrawn in a second direction opposite to the first direction (e.g., in the proximal direction P). For example, the first insertion needle 140 and / or cannula 102 may include structural features (same as or different from the first structural feature) configured to allow the first insertion needle 140 to move substantially independently of the cannula 102 when the first insertion needle 140 is retracted in a second direction.

[0111] The first insertion needle 140 may be configured to engage the cannula 102 in any manner sufficient to cause the first insertion needle 140 to translate the first end 124 of the cannula toward the user in a first direction, and / or allow the first insertion needle 140 to move substantially independently of the cannula 102 when retracted in a second direction. In some embodiments, the first insertion needle 140 is configured to extend at least partially within the lumen 128 to cause translation of the first end 124 of the cannula in a first direction (e.g., distal direction D). When the first insertion needle 140 is retracted in the second direction, the first insertion needle 140 may be configured to extend within the lumen 128 when the first insertion needle 140 moves substantially independently of the cannula 102. In other embodiments, the first insertion needle 140 may be configured to substantially surround a portion of the cannula 102 to cause translation of the first end 124 of the cannula in the first direction and / or allow the first insertion needle 140 to move substantially independently of the cannula 102 when retracted in the second direction.

[0112] In some instances, cannula 102 defines a T-joint, wherein the first end 124 of the cannula defines an opening at one end of the crossbar of the T-joint, and the cannula 102 defines a needle passage 196 at the other end of the crossbar. Figure 4AIn one example, the first insertion needle 140 is configured to extend through the lumen 128 of the cannula 102 by extending through the needle passage 196 and the first end 124 of the cannula. The first insertion needle 140 may be configured to be withdrawn through the needle passage 196 when the infusion device 100 causes the first insertion needle 140 to retract while the first end 124 of the cannula is retained in the user's body. In one example, the second diaphragm 165 is configured to fluidly isolate the needle passage 196 from portions of the infusion device 100, such as the first connector 132, the second connector 136, the first facing surface 150, the second facing surface 152, and / or other components of the first unit 106 and / or the second unit 108. The second diaphragm 165 may be configured to self-seal when the first insertion needle 140 is withdrawn through the second diaphragm 165 (e.g., in the distal direction D) to substantially maintain fluid isolation.

[0113] In one example, the first insertion needle 140 is configured to substantially engage with the cannula 102 when a force is applied to the cannula 102 in a first direction (e.g., distal direction D). The first insertion needle 140 may be configured such that a subsequent force in a second direction (e.g., proximal direction P) causes the first insertion needle 140 to disengage (e.g., disengage) and move independently of the cannula 102. In another example, the first insertion needle 140 includes a support surface configured such that when a force is applied to the first insertion needle 140 in the first direction, the support surface engages a portion of the cannula 102 and transmits a portion of the force to the cannula 102, and when a force is applied to the first insertion needle 140 in the second direction, the support surface displaces from the cannula 102, allowing the first insertion needle 140 to move independently of the cannula 102. Therefore, the infusion device 100 can be configured to withdraw the first insertion needle 140 independently of the cannula 102, such that the first end 124 of the cannula remains implanted when the first insertion needle 140 is retracted.

[0114] As discussed, the second insertion pin 142 is configured to releasably engage the sensor 104 to induce implantation of the sensor 104 within the user's body. The second insertion pin 142 and the sensor 104 are cooperatively configured and arranged such that when the second insertion pin 142 extends toward the user in a first direction (e.g., in the distal direction D), the second insertion pin 142 releasably carries at least a portion (e.g., the distal portion) of the sensor 104. The second insertion pin 142 can be configured to engage the sensor 104 in any manner sufficient to cause the second insertion pin 142 to translate toward the user in the first direction, and / or allow the second insertion pin 142 to move substantially independently of the sensor 104 when retracted in a second direction.

[0115] In some instances, the second insertion pin 142 is configured to at least partially surround the sensor 104 to carry the sensor 104 as the second insertion pin 142 extends through the first unit 110 in a first direction. The second insertion pin 142 may be configured as a substantially hollow pin defining a gap in which the sensor 104 is accommodated. The second insertion pin 142 and / or the sensor 104 may be configured such that the second insertion pin 142 mechanically engages the sensor 104 when extending in the first direction (e.g., distal direction D), and disengages from the sensor 104 when retracting in a second direction (e.g., proximal direction P). In other instances, the second insertion pin 142 may be configured to be substantially inserted into a portion of the sensor 104 (e.g., such that a portion of the sensor 104 substantially surrounds a portion of the second insertion pin 142) such that the sensor 104 is translated in a first direction, and / or the second insertion pin 142 is allowed to move substantially independently of the sensor 104 when it retracts in a second direction.

[0116] In one example, the second insertion pin 142 and / or the sensor 104 include a second structural feature (e.g., a gap defined by the second insertion pin) configured to cause the second insertion pin 142 to apply force to the sensor 104 when the second insertion pin 142 extends in the first direction. The second insertion pin 142 may be configured to engage the sensor 104 to cause the sensor 104 to be implanted into the user's body when the second insertion pin 142 extends in the first direction. The sensor 104 may be configured to extend from the first housing 110 when the second insertion pin 142 causes the sensor 104 to be implanted into the user's body.

[0117] The second insertion needle 142 may be configured to disengage (e.g., release) from the sensor 104 when the second insertion needle 142 is subsequently retracted in a second direction (e.g., in the proximal direction P). For example, the second insertion needle 142 and / or the sensor 104 may include structural features (same or different from the second structural feature) configured to allow the second insertion needle 142 to move substantially independently of the sensor 104 when retracted in the second direction. In some instances, the second insertion needle 142 is configured such that body tissue within the user's body engages with the sensor 104 when the second insertion needle 142 is retracted, such that the sensor 104 remains implanted within the user's body when the second insertion needle 142 is withdrawn. For example, the second insertion needle 142 may include a portion defining a longitudinal opening (e.g., a distal portion) such that a portion of the sensor 104 is exposed to body tissue when the second insertion needle 142 is inserted into the user's body. When the second insertion needle 142 is retracted, body tissue can be used to grasp (e.g., frictionally engage) the exposed portion of the sensor 104, allowing the second insertion needle 142 to be withdrawn while the sensor 104 remains implanted in the user's body. In examples, the sensor 104 may include one or more structural features configured to assist in frictional engagement with body tissue. In some examples, the infusion device 100 may be configured to mechanically engage the sensor 104 to hold the sensor 104 in place (e.g., within the user's body) when the second insertion needle 142 is retracted in a second direction.

[0118] The sensor 104 can be fabricated using a flexible or pliable substrate or carrier. In some examples, the sensor 104 is initially provided in a folded, serpentine, coiled, or accordion-pleated shape to provide the necessary slack to accommodate an extended sensor 104, for example, when the sensor 104 is electrically coupled to the second connector 136. The sensor 104 can be configured such that when the second insertion pin 142 carries the sensor 104 in a second direction (e.g., in the distal direction D), the sensor 104 extends without losing electrical contact with the second connector 136.

[0119] The first connector 132 and / or the second connector 136 may have any configuration sufficient to allow electrical communication to be established when the second housing 116 engages with the first housing 110. In examples, the first connector 132 and / or the second connector 136 include a flexible or resilient block that substantially covers and / or supports one or more conductors. In examples, the block comprises silicone and / or some other substantially insulating material. In examples, the conductor comprises carbon pillars and / or some other substantially conductive material. In some examples, the first connector 132 and / or the second connector 136 are configured to compress (e.g., reduce volume) when the second housing 116 engages with the first housing 110 and electrical communication is established between the first connector 132 and the second connector 136.

[0120] Figure 9 The document describes the techniques used to implant cannulas and sensors into a user's body. Although primarily referenced... Figures 1 to 8D The technology described in infusion device 100 is applicable to other infusion devices in other instances.

[0121] The technology includes engaging (202) a second housing 116 of the second unit 108 with a first housing 110 of the first unit 106. The first housing 110 is accessible to a user's skin 118. The first unit 106 may include a fluid reservoir 112 and processing circuitry 114. The second unit 108 may include a first insertion needle 140 and a second insertion needle 142. The technology may include releasably engaging a cannula 102 using the first insertion needle 140 and releasably engaging a sensor 104 using the second insertion needle 142.

[0122] The technique includes inserting a cannula 102 (204) through a first unit first channel 148 and inserting a sensor 104 (206) through a first unit second channel 154. The first unit first channel 148 and the first unit second channel 154 may be defined by a first housing 110. In an example, the technique includes inserting the cannula 102 through the first unit first channel 148 using a first insertion needle 140. The technique may include inserting the sensor 104 through the first unit second channel 154 using a second insertion needle 142. In an example, the technique includes extending the first insertion needle 140 through the first unit first channel 148 by translating the second unit 108 toward (e.g., in a distal direction D) the first unit 110. The technique may include extending the second insertion needle 142 through the first unit second channel 154 by translating the second unit 108 toward (e.g., in a distal direction D) the first unit 110.

[0123] The technique may include extending a first insertion needle 140 through a first channel 148 of a first unit and through a first aperture 115 defined by a first housing 110. The technique may include translating a first end 124 of a cannula through the first aperture 115. The first aperture 115 may be defined in a base surface 111 of the first housing 110 configured to be positioned close to a user's skin 118. The technique may include piercing the user's skin 118 with the distal end 144 of the first needle and causing the first end 124 of the cannula to be implanted into the user's body. In an example, the technique includes extending a second insertion needle 142 through a second channel 154 of a first unit and through a second aperture 117 defined by the first housing 110. The technique may include translating at least a portion of a sensor 104 through the second aperture 117 (206). The second aperture 117 may be defined in the base surface 111 of the first housing 110. The technique may include piercing the user's skin 118 with the distal end 146 of a second needle and causing at least a portion of the sensor 104 to be implanted into the user's body.

[0124] The technique may include causing the second housing 116 to engage the first housing 110 such that the first housing 110 substantially restricts the movement of the second housing 116 relative to the first housing 110. In an example, the technique includes causing the second housing 116 to restrict the relative movement of the second housing 116 using a fixing device 120.

[0125] In one example, the technique includes inserting a second end 126 of the cannula into a fluid passage 130 when the second housing 116 engages with the first housing 110. The fluid passage 130 may be defined by the first housing 110. In one example, the fluid passage 130 is in fluid communication with a fluid reservoir 112 of the first unit 110. In one example, the technique includes establishing fluid communication with the cannula 102 and the fluid reservoir 112 when the second end 126 of the cannula is inserted into the fluid passage 130. In one example, the technique includes establishing fluid communication between the fluid reservoir 112 and the first end 124 of the cannula via a lumen 128 of the cannula 102. The technique may include causing the second end 126 of the cannula to puncture a passage diaphragm 163 configured to fluidly isolate a portion of the fluid passage 130 from the infusion device 100. In some examples, the technique includes using a fluid pump 127 to cause fluid to flow from the fluid reservoir 112 to the first end 124 of the cannula. The technology may include using processing circuitry 114 to control the operation of fluid pump 127.

[0126] In one example, the technology includes electrically connecting a first connector 132 of the first unit 106 and a second connector 136 of the second unit 108 when the second housing 116 engages with the first housing 110. The first connector 132 may be electrically connected to processing circuitry 114. The second connector 136 may be electrically connected to processing circuitry 114. In one example, the technology includes establishing an electrical connection between sensor 104 and processing circuitry 114 when the first connector 132 and the second connector 136 are electrically connected. The technology may include using the electrical connection between sensor 104 and processing circuitry to transmit signals indicative of a user's physiological characteristics to processing circuitry 114. In one example, the technology includes using processing circuitry 114 to control the operation of fluid pump 127 based on the indicative signals.

[0127] The technology may include retracting the first insertion pin 140 and the second insertion pin 142 when the second unit 108 engages with the first unit 106. The technology may include retracting the first insertion pin 140 and the second insertion pin 142 in a direction away from the first housing 110 (e.g., in the proximal direction P). In an example, the technology includes causing the first insertion pin 140 to release the cannula 102 when retracted. The technology may include mechanically disengaging the first insertion pin 140 from the cannula 102 such that the first end 124 of the cannula remains implanted in the user's body when the first insertion pin 140 is retracted. In an example, the technology includes causing the second insertion pin 142 to release the sensor 104 when retracted. The technology may include mechanically disengaging the second insertion pin 142 from the sensor 104 such that at least a portion of the sensor 104 remains implanted in the user's body when the second insertion pin 142 is retracted.

[0128] In one example, the technique includes positioning the second unit 108 within the inserter 170. The technique may include moving the second unit 108 toward the first unit 106 using the inserter 170. In some examples, the technique includes causing the inserter 170 to move the second unit 108 toward the first unit 106 by means of an actuating plunger 172. In one example, the plunger 172 is configured to compress an insertion spring 186. The technique may include using the expansion of the insertion spring to cause the second unit 108 to move toward the first unit 106.

[0129] In one example, inserter 170 is configured to displace first insertion pin 140 along axis A1 extending through first channel 148 of first unit when second unit 108 moves toward first unit 106. In another example, inserter 170 is configured to displace second insertion pin 142 along axis A2 extending through second channel 154 of first unit when second unit 108 moves toward first unit 106. In another example, inserter 170 is configured to displace second end 126 of cannula along axis A3 extending through fluid passage 130 when second unit 108 moves toward first unit 106. In another example, inserter 170 is configured to displace second connector 136 along axis A4 extending through first connector 132 when second unit 108 moves toward first unit 106. In yet another example, the technique includes engaging insertion member 174 of inserter 170 with first unit 106. The technology may include, when the insertion member 174 engages with the first unit 106 using the insert 170, shifting the first insertion pin 140 on axis A1, shifting the second insertion pin 142 on axis A2, shifting the second end 126 of the cannula on axis A3, and / or shifting the second connector 136 on axis A4.

[0130] In one example, the technique includes withdrawing a first insertion needle 140 and a second insertion needle 142 from the first unit 106 and the second unit 108 using an inserter 170 (e.g., in the proximal direction P). The technique may include withdrawing the first insertion needle 140 and the second insertion needle 142 using the expansion of an extraction spring 194. In another example, the technique includes causing the first insertion needle 140 to release the cannula 102 and causing the second insertion needle 142 to release the sensor 104 by withdrawing the first insertion needle 140 and the second insertion needle 142. The technique may include withdrawing the first insertion needle 140 and the second insertion needle 142 by causing the needle holder 156 to move in a direction away from the first housing 110 and the second housing 116 (e.g., in the proximal direction P).

[0131] The techniques and functionalities described herein, including those attributable to processor 143, processing circuitry, sensors, and / or various constituent components, can be implemented at least partially in hardware, software, firmware, or any combination thereof. For example, aspects of the technology 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 embodied in any suitable device, and any combination of such components. Processing circuitry, control circuitry, and sensing circuitry, as well as other processors, controllers, and sensors described herein, can be implemented at least partially as or include, for example, one or more executable applications, application modules, libraries, classes, methods, objects, routines, subroutines, firmware, and / or embedded code. Furthermore, analog circuitry, components, and circuit elements can be used to construct one, some, or all of the control circuitry and sensors, replacing or supplementing some or all of the digital hardware and / or software described herein. Therefore, analog or digital hardware, or a combination of both, can be employed.

[0132] In one or more instances, the techniques and functions described in this disclosure may be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functions may be stored as one or more instructions or code on a computer-readable medium and executed by a hardware-based processing unit. The computer-readable medium may be an article of manufacture comprising a non-transitory computer-readable storage medium encoded with instructions. Instructions embedded or encoded in an article of manufacture comprising an encoded non-transitory computer-readable storage medium may enable one or more programmable processors or other processors to implement one or more of the techniques described herein, for example when the instructions included or encoded in the non-transitory computer-readable storage medium are executed by one or more processors. Exemplary non-transitory computer-readable storage media may include RAM, ROM, programmable ROM (PROM), erasable programmable ROM (EPROM), electronically erasable programmable ROM (EEPROM), flash memory, hard disk, compact disc ROM (CD-ROM), floppy disk, magnetic tape cassette, magnetic media, optical media, or any other computer-readable storage device or tangible computer-readable medium.

[0133] In some instances, computer-readable storage media may contain non-transitory media. The term "non-transitory" may indicate that the storage medium is not embodied in a carrier wave or a propagating signal. In some instances, non-transitory storage media may store data that may change over time (e.g., in RAM or cache memory).

[0134] The functions described herein can be housed within dedicated hardware and / or software modules. Describing 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 implemented by separate hardware or software components. Rather, the functions associated with one or more modules or units can be performed by separate hardware or software components, or integrated into shared or separate hardware or software components. Furthermore, the technology can be fully implemented within one or more circuit or logic elements.

[0135] This disclosure includes the following examples.

[0136] Example 1: An infusion device comprising: a first unit defining a first housing, wherein the first housing defines a first channel extending through the first housing, a second channel extending through the first housing, and a fluid passage, wherein the first unit includes processing circuitry and a fluid reservoir in fluid communication with the fluid passage; and a second unit defining a second housing configured to engage the first housing, the second unit comprising: a cannula having a first end and a second end; a sensor; a first insertion needle releasably carrying the cannula; and a second insertion needle releasably carrying the sensor, wherein: the first insertion needle is configured to insert the first end of the cannula through the first channel when the second housing engages the first housing, the second insertion needle is configured to insert the sensor through the second channel when the second housing engages the first housing, the second end of the cannula is configured to insert through the fluid passage when the second housing engages the first housing, and the infusion device is configured to electrically connect the sensor and the processing circuitry when the second housing engages the first housing.

[0137] Example 2: The infusion device according to Example 1, wherein: a first insertion needle defines a distal end of a first needle configured to pierce the user's skin, a second insertion needle defines a distal end of a second needle configured to pierce the user's skin, the first insertion needle is configured to extend through a first channel and displace the distal end of the first needle away from the first housing to pierce the user's skin when the second housing engages with the first housing, and the second insertion needle is configured to extend through a second channel and translate the distal end of the second needle in a direction away from the first housing to pierce the user's skin when the second housing engages with the first housing.

[0138] Example 3: An infusion device according to Example 1 or 2, wherein the second unit defines a second unit first channel extending through the second housing and a second unit second channel extending through the second housing, wherein a first insertion needle extends through the second unit first channel and a second insertion needle extends through the second unit first channel.

[0139] Example 4: An infusion device according to any one of Examples 1 to 3, wherein a first insertion needle is configured to be withdrawn from a first channel of a second unit and a first channel of a first unit when the second housing engages with a first housing, and wherein a second insertion needle is configured to be withdrawn from a second channel of a second unit and a second channel of a first unit when the second housing engages with a first housing.

[0140] Example 5: An infusion device according to any one of Examples 1 to 4, wherein the sensor is a glucose sensor and the cannula is configured to deliver insulin from a fluid reservoir when the second housing engages the first housing.

[0141] Example 6: An infusion device according to any one of Examples 1 to 5, wherein the second unit is configured to withdraw a first end of the cannula from the first channel, a second end of the cannula from the fluid passage, and a sensor from the second channel when the second housing disengages from the first housing.

[0142] Example 7: An infusion device according to any one of Examples 1 to 6, wherein the second unit is configured to translate in a first direction such that the second housing engages with the first housing, and wherein: the first insertion needle is configured to translate in the first direction when the second unit translates in the first direction to insert a first end of a cannula into the user's body; the second insertion needle is configured to translate in the first direction when the second unit translates in the first direction to insert a sensor into the user's body; the first insertion needle is configured to release the first end of the cannula when the first insertion needle translates in a second direction opposite to the first direction, such that when the first insertion needle is withdrawn from the user, the first end of the cannula remains inserted into the user's body; and the second insertion needle is configured to release the sensor when the first insertion needle translates in the second direction opposite to the first direction, such that when the first insertion needle is withdrawn from the user, the first end of the cannula remains inserted into the user's body.

[0143] Example 8: An infusion device according to any one of Examples 1 to 7, wherein the cannula is configured to establish fluid communication from the first end of the cannula to the fluid reservoir when the second end of the cannula is inserted through the fluid passage.

[0144] Example 9: An infusion device according to any one of Examples 1 to 8, wherein the first unit includes a passage diaphragm configured to fluidly isolate a fluid reservoir from a second housing, wherein a second end of a cannula is configured to puncture the passage diaphragm when the second end of the cannula is inserted through the fluid passage.

[0145] Example 10: An infusion device according to any one of Examples 1 to 9, wherein: a first insertion needle defines a first needle distal end configured to pierce the user's skin, a second insertion needle defines a second needle distal end configured to pierce the user's skin, and the infusion device is configured such that the first needle distal end and the second needle distal end pierce the user's skin substantially simultaneously.

[0146] Example 11: An infusion device according to any one of Examples 1 to 10, wherein the first unit includes a first electrical contact electrically connected to a processing circuit, and wherein the second unit includes a second electrical contact electrically connected to a sensor, and wherein the first and second electrical contacts are configured to establish an electrical connection between the sensor and the processing circuit when the second housing engages the first housing.

[0147] Example 12: An infusion device according to any one of Examples 1 to 11, wherein the first unit further includes a fluid pump configured to deliver fluid from a fluid reservoir to a fluid passage.

[0148] Example 13: An infusion device according to any one of Examples 1 to 12, wherein the processing circuit is configured to: receive a signal from a sensor indicating the physiological characteristics of a user; and control the operation of a fluid pump based on the indication signal.

[0149] Example 14: An infusion device according to any one of Examples 1 to 13, further comprising an inserter configured to translate a second unit toward a first unit such that a second housing engages with a first housing, wherein: the inserter is configured to engage with the first housing; the inserter is configured to align a distal end of a first insertion needle with a first channel when the inserter engages with the first housing; the inserter is configured to align a distal end of a second insertion needle with a second channel when the inserter engages with the first housing; and the inserter is configured to align a second end of a cannula with a fluid passage when the inserter engages with the first housing.

[0150] Example 15: An infusion device according to any one of Examples 1 to 14, further comprising an inserter and a carrier attached to a first inserter and a second inserter, wherein: the inserter is configured to translate the second unit and the carrier toward the first unit in a first direction such that the second housing engages with the first housing; and the inserter is configured to translate the carrier, the first inserter and the second inserter away from the second housing in a second direction opposite to the first direction when the second housing engages with the first housing.

[0151] Example 16: An infusion device comprising: a first unit defining a first housing, wherein the first housing defines a first channel extending through the first housing, a second channel extending through the first housing, and a fluid passage, and wherein the first unit includes processing circuitry, a fluid reservoir, and a fluid pump in fluid communication with the fluid passage; and a second unit defining a second housing configured to engage the first housing, the second unit comprising: a cannula having a first end and a second end; and a sensor; a first insertion needle releasably carrying the cannula and configured to extend through the first channel; and a second insertion needle releasably carrying the sensor and configured to extend through the second channel, wherein: the first housing is configured to when When the second housing engages the first housing, the second housing is substantially fixed and does not move relative to the first housing. The first insertion needle is configured to extend a portion of the cannula, including a first end, through the first channel when the first insertion needle extends through the first channel. The second insertion needle is configured to extend a portion of the sensor through the second channel when the second insertion needle extends through the second channel. The second end of the cannula is configured to be inserted through a fluid passage when the second housing engages the first housing. The cannula is configured to establish fluid communication from the first end of the cannula to the fluid reservoir when the second end of the cannula is inserted through the fluid passage. The infusion device is configured to electrically connect the sensor and the processing circuit when the second housing engages the first housing.

[0152] Example 17: The infusion device according to Example 16 further includes an inserter, wherein the second unit includes a carrier attached to a first inserter and a second inserter, wherein the inserter is configured to: releasably engage with a first housing; align the distal end of the first needle with a first channel when the inserter is releasably engaged with the first housing; align the distal end of the second needle with a second channel when the inserter is releasably engaged with the first housing; and align the second end of the cannula with a fluid passage when the inserter is releasably engaged with the first housing, wherein the inserter is configured to translate the second unit toward the first unit in a first direction such that the second housing engages with the first housing, and wherein the inserter is configured to translate the carrier, the first inserter, and the second inserter away from the second housing in a second direction opposite to the first direction when the second housing engages with the first housing.

[0153] Example 18: An infusion device according to Example 16 or 17, wherein the processing circuit is configured to: receive a signal from a sensor indicating the user's physiological characteristics; and control the operation of a fluid pump based on the indication signal.

[0154] Example 19: A method comprising: engaging a first housing defined by a first unit and a second housing defined by a second unit, wherein the first unit includes processing circuitry and a fluid reservoir, and wherein the second unit includes a first insertion needle, a second insertion needle, a cannula, and a sensor; when the second housing engages the first housing, inserting a first end of the cannula through a first channel defined by the first housing using the first insertion needle; when the second housing engages the first housing, inserting the sensor through a second channel defined by the first housing using the second insertion needle; when the second housing engages the first housing, inserting a second end of the cannula into a fluid passage defined by the first housing; and when the second housing engages the first housing, electrically connecting the sensor to the processing circuitry.

[0155] Example 20: The method according to Example 19 further includes: translating the second unit in a first direction to engage the first housing and the second housing; and translating the first insertion pin and the second insertion pin in a second direction opposite to the first direction when the first housing is engaged in a second direction.

[0156] Various examples have been described. These are other examples within the scope of this disclosure.

Claims

1. An infusion device comprising: A first unit defines a first housing, wherein the first housing defines a first channel extending through the first housing, a second channel extending through the first housing, and a fluid passage, wherein the first unit includes processing circuitry and a fluid reservoir in fluid communication with the fluid passage; and A second unit, which defines a second housing configured to engage the first housing, the second unit comprising: A cannula, having a first end and a second end; sensor; A first insertion needle, which releasably carries the cannula; and A second insertion pin, which releasably carries the sensor, wherein: The first insertion needle is configured to be inserted through the first channel into the first end of the cannula when the second housing engages the first housing. The second insertion pin is configured to be inserted into the sensor through the second channel when the second housing engages the first housing. The second end of the cannula is configured to be inserted through the fluid passage when the second housing engages the first housing, and The infusion device is configured to electrically connect the sensor and the processing circuit when the second housing engages the first housing.

2. The infusion device according to claim 1, wherein: The first insertion needle is defined as the distal end of a first needle configured to pierce the user's skin. The second insertion needle is defined as the distal end of a second needle configured to pierce the user's skin. The first insertion needle is configured to extend through the first channel and, when the second housing engages the first housing, to displace the distal end of the first needle away from the first housing to pierce the user's skin. The second insertion needle is configured to extend through the second channel and, when the second housing engages with the first housing, to translate the distal end of the second needle in a direction away from the first housing to pierce the user's skin.

3. The infusion device of claim 1, wherein the second unit defines a second unit first channel extending through the second housing and a second unit second channel extending through the second housing, wherein the first insertion needle extends through the second unit first channel and the second insertion needle extends through the second unit first channel.

4. The infusion device according to claim 3, wherein the first insertion needle is configured to be withdrawn from the first channel of the second unit and the first channel of the first unit when the second housing engages with the first housing, and wherein the second insertion needle is configured to be withdrawn from the second channel of the second unit and the second channel of the first unit when the second housing engages with the first housing.

5. The infusion device of claim 1, wherein the sensor is a glucose sensor, and the cannula is configured to deliver insulin from the fluid reservoir when the second housing engages the first housing.

6. The infusion device of claim 1, wherein the second unit is configured to withdraw the first end of the cannula from the first channel, the second end of the cannula from the fluid passage, and the sensor from the second channel when the second housing disengages from the first housing.

7. The infusion device of claim 1, wherein the second unit is configured to translate in a first direction such that the second housing engages with the first housing, and wherein: The first insertion needle is configured to translate in the first direction when the second unit translates in the first direction to implant the first end of the cannula into the user's body. The second insertion needle is configured to translate in the first direction when the second unit translates in the first direction to implant the sensor into the user's body. The first insertion needle is configured to release the first end of the cannula when the first insertion needle is translated in a second direction opposite to the first direction, such that when the first insertion needle is withdrawn from the user, the first end of the cannula remains implanted in the user's body, and The second insertion needle is configured to release the sensor when the second insertion needle is translated in a second direction opposite to the first direction, such that the sensor remains implanted in the user's body when the second insertion needle is withdrawn from the user.

8. The infusion device of claim 1, wherein the cannula is configured to establish fluid communication from the first end of the cannula to the fluid reservoir when the second end of the cannula is inserted through the fluid passage.

9. The infusion device of claim 1, wherein the first unit includes a passage diaphragm configured to fluidly isolate the fluid reservoir from the second housing, wherein the second end of the cannula is configured to puncture the passage diaphragm when the second end of the cannula is inserted through the fluid passage.

10. The infusion device according to claim 1, wherein: The first insertion needle is defined as the distal end of a first needle configured to pierce the user's skin. The second insertion needle is defined as the distal end of a second needle configured to pierce the user's skin, and The infusion device is configured such that the distal ends of the first needle and the distal ends of the second needle pierce the user's skin substantially simultaneously.

11. The infusion device of claim 1, wherein the first unit includes a first electrical contact electrically connected to the processing circuit, and wherein the second unit includes a second electrical contact electrically connected to the sensor, and wherein the first electrical contact and the second electrical contact are configured to establish the electrical connection between the sensor and the processing circuit when the second housing engages the first housing.

12. The infusion device of claim 1, wherein the first unit further comprises a fluid pump configured to deliver fluid from the fluid reservoir to the fluid passage.

13. The infusion device according to claim 12, wherein the processing circuit is configured to: Receive indication signals from the sensor that indicate the user's physiological characteristics; and The operation of the fluid pump is controlled based on the indicated signal.

14. The infusion device of claim 1, further comprising an inserter configured to translate the second unit toward the first unit such that the second housing engages with the first housing, wherein: The inserter is configured to mate with the first housing. The inserter is configured such that, when the inserter engages with the first housing, the distal end of the first insertion pin aligns with the first channel. The inserter is configured such that when the inserter engages with the first housing, the distal end of the second needle of the second insertion pin aligns with the second channel, and The inserter is configured to align the second end of the cannula with the fluid passage when the inserter engages with the first housing.

15. The infusion device according to claim 1, further comprising an inserter and a carrier attached to the first inserter and the second inserter, wherein: The inserter is configured to translate the second unit and the carrier toward the first unit in a first direction such that the second housing engages with the first housing; and The inserter is configured to cause the carrier, the first insert pin, and the second insert pin to translate away from the second housing in a second direction opposite to the first direction when the second housing engages the first housing.

16. An infusion device comprising: A first unit defines a first housing, wherein the first housing defines a first channel extending through the first housing, a second channel extending through the first housing, and a fluid passage, wherein the first unit includes processing circuitry, a fluid reservoir, and a fluid pump in fluid communication with the fluid passage; and A second unit, which defines a second housing configured to engage the first housing, the second unit comprising: Intubation, having a first end and a second end; and sensor; A first insertion needle releasably carries the cannula and is configured to extend through the first channel; and A second insertion pin, which releasably carries the sensor and is configured to extend through the second channel, wherein: The first housing is configured to substantially fix the second housing in place and prevent it from moving relative to the first housing when the second housing engages with the first housing. The first insertion needle is configured to extend a portion of the cannula, including the first end, through the first channel when the first insertion needle extends through the first channel. The second insertion pin is configured to extend a portion of the sensor through the second channel when the second insertion pin extends through the second channel. The second end of the cannula is configured to be inserted through the fluid passage when the second housing engages the first housing, wherein the cannula is configured to establish fluid communication from the first end of the cannula to the fluid reservoir when the second end of the cannula is inserted through the fluid passage. The infusion device is configured to electrically connect the sensor and the processing circuit when the second housing engages the first housing.

17. The infusion device of claim 16, further comprising an inserter, wherein the second unit includes a carrier attached to the first inserter and the second inserter. The inserter is configured to: It can be releasably engaged with the first housing. When the inserter releasably engages with the first housing, it aligns the distal end of the first insertion pin with the first channel. When the inserter is releasably engaged with the first housing, the distal end of the second insertion pin is aligned with the second channel, and When the inserter is releasably engaged with the first housing, the second end of the cannula is aligned with the fluid passage, and The inserter is configured to translate the second unit toward the first unit in a first direction such that the second housing engages with the first housing. The inserter is configured to cause the carrier, the first insert needle, and the second insert needle to translate away from the second housing in a second direction opposite to the first direction when the second housing engages with the first housing.

18. The infusion device according to claim 16, wherein the processing circuit is configured to: Receive indication signals from the sensor that indicate the user's physiological characteristics; and The operation of the fluid pump is controlled based on the indicated signal.

Images