US20200214633A1

Movatterモバイル変換

Info

Publication number: US20200214633A1
Application number: US16/824,624
Authority: US
Inventors: David C. Antonio; Eric Allan Larson; Jose J. Ruelas
Original assignee: Medtronic Minimed Inc
Current assignee: Medtronic Minimed Inc
Priority date: 2016-04-08
Filing date: 2020-03-19
Publication date: 2020-07-09
Also published as: US20170290532A1; US10413183B2; US10631787B2; US20200015749A1; US20190350527A1; US20170290533A1; US11547357B2; US20170290512A1; US10420508B2; US20240023894A9

Abstract

This disclosure generally relates to medical devices that include a transmitter assembly positioned on top of a sensor assembly. A sensor assembly includes a sensor base having a bottom surface and a top surface having an interface. The interface accommodates a sensor stack that includes at least one sensor head having electrical contact pads connected to an elastomeric connector. The sensor assembly further includes a mounting base having a first side that attaches to the bottom surface of the sensor base, and a second side that adheres to a patient's skin. A transmitter assembly includes a transmitter shell and a transmitter cap having an interface that engages with the sensor base. Also, the transmitter assembly includes electrical contacts disposed on the transmitter cap that connect with the electrical contact pad(s) of the sensor assembly.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No. 15/357,885, filed Nov. 21, 2016, which claims priority to and the benefit of: U.S. Provisional Patent Application Ser. No. 62/320,290, filed on Apr. 8, 2016 (now expired); U.S. Provisional Application Ser. No. 62/344,847, filed on Jun. 2, 2016 (now expired); U.S. Provisional Patent Application Ser. No. 62/344,852, filed on Jun. 2, 2016 (now expired); and U.S. Provisional Patent Application Ser. No. 62/402,676, filed on Sep. 30, 2016 (now expired).

TECHNICAL FIELD

Embodiments of the present disclosure generally relate to medical devices, and more particularly, to medical devices or products having a sensor and a transmitter and their associated components, connections and arrangement techniques.

BACKGROUND

Diabetes is a disease in which the body does not produce or properly use insulin. Millions of people in the United States and around the world have been diagnosed with some form of diabetes.Type 1 diabetes results from the body's failure to produce insulin.Type 2 diabetes results from insulin resistance in which the body fails to properly use insulin. In order to effectively manage the disease, diabetics must closely monitor and manage their blood glucose levels through exercise, diet and medications. In particular, bothType 1 andType 2 diabetics rely on insulin delivery and blood glucose monitoring to control their diabetes.

External infusion devices have been used to deliver medication to a patient as generally described in U.S. Pat. Nos. 6,554,798 and 6,551,276 which are specifically incorporated by reference herein. In addition to delivering medication to a patient, other medical devices have been used to determine body characteristics by obtaining a sample of bodily fluid. A variety of implantable electrochemical sensors have been developed for detecting and/or quantifying specific agents or compositions in a patient's blood. For instance, glucose sensors have been developed for use in obtaining an indication of blood glucose levels in a diabetic patient. Such readings can be especially useful in monitoring and/or adjusting a treatment regimen that typically includes the regular administration of insulin to the patient. Thus, blood glucose readings are particularly useful in improving medical therapies with semi-automated medication infusion pumps of the external type and/or implantable type.

Monitoring blood glucose levels plays an integral role in the management and control of diabetes. Finger stick measurements, glucose sensors and monitors have traditionally been used to check the blood glucose levels of diabetic patients. In recent years, continuous glucose monitoring systems have been developed utilizing the latest sensor technologies incorporating both implantable and external sensors as generally described in U.S. Pat. No. 5,391,250 entitled “Method of Fabricating Thin Film Sensors”, U.S. Pat. No. 6,484,046 entitled “Electrochemical Analyte Sensor,” and U.S. Pat. Nos. 5,390,671, 5,568,806 and 5,586,553, entitled “Transcutaneous Sensor Insertion Set,” all of which are specifically incorporated by reference herein. Newer systems deliver the preciseness of finger stick measurements coupled with the convenience of not having to repeatedly prick the skin to obtain glucose measurements. These newer systems provide the equivalent of over 200 finger stick readings per day. Additionally, continuous glucose monitoring systems allow physicians and patients to monitor blood glucose trends of their body and suggest and deliver insulin based on each patient's particular needs. Accordingly, physicians and medical device companies are always searching for more convenient ways to keep diabetic patients aware of their blood glucose levels throughout the day.

As such, physiological characteristic (or analyte) sensors may be generally used to test analyte levels in patients. For example, thin film sensors may be used for obtaining an indication of blood glucose levels and monitoring blood glucose levels in a diabetic patient. In these instances, a portion of a glucose sensor is positioned subcutaneously/transcutaneously in direct contact with patient extracellular fluid. Glucose sensor readings can be especially useful in adjusting a treatment regimen that typically includes regular administration of insulin to the patient.

A glucose sensor may be packaged and sold as a product that includes certain features or components that allow the patient to position and subcutaneously/transcutaneously implant the sensor. For example, thin film glucose sensors are often implanted subcutaneously/transcutaneously using an introducer needle, which is packaged with the glucose sensor. The introducer needle is used to puncture the skin of a patient at the same time as the sensor is introduced. The introducer needle is then withdrawn, leaving the sensor in the skin of the patient. The introducer needle is used and then discarded after inserting the sensor at the sensor site. Currently, some sensor platforms use a multiple-use, durable insertion device. This type of durable insertion device presents various issues. For example, the use model for this type of durable insertion device is generally complex, that is, the current process requires many complex steps, some of which may require fine motor skills for the user. Current durable insertion devices are also prone to wear and damage. Also, in general, current sensor platforms require users to carry both packaged sensors and an insertion device. If the user is not carrying the insertion device, the user cannot insert the sensor. In addition, durable insertion devices generally require disinfection or cleaning such as in a clinical setting.

Once a continuous glucose sensor is inserted, the continuous glucose sensor is designed to monitor glucose concentration of the patient and a sensor signal is produced that is representative of the glucose concentration. The continuous glucose sensor may use wireless data communication techniques to transmit data indicative of the blood glucose levels to a receiving device such as a portable infusion pump, a glucose monitor device, and/or the like. For example, the transmitted sensor signal may be used to generate a controller input for a controller to generate commands that affect the operation of a delivery system to infuse a liquid, which includes insulin, into the patient.

Typical devices or products generally include a sensor and a transmitter that are placed side by side.

SUMMARY

Embodiments of the present disclosure generally relate to medical devices that include a sensor assembly and a transmitter assembly, for example, a transmitter assembly positioned on top of a sensor assembly. This arrangement addresses issues created by typical side-by-side arrangements including, for example, issues with on-body device stability, robustness of connections, comfort, overall use model, etc.

According to an embodiment, a device includes a sensor assembly that includes: a sensor base having a top surface and a bottom surface, at least one interface disposed on the top surface of the sensor base, where the interface(s) accommodates a sensor stack, the sensor stack including at least one sensor head having at least one electrical contact pad adapted to connect to at least one elastomeric connector. The sensor assembly also includes a mounting base having a first side that attaches to at least a portion of the bottom surface of the sensor base, and a second side that is adapted to adhere to a user's skin. The device also includes a transmitter assembly adapted to connect with the top surface of the sensor base of the sensor assembly, the transmitter assembly including: a transmitter shell and a transmitter cap having an interface adapted to engage with the sensor base; and at least one electronics module including at least one electrical contact disposed on the transmitter cap, where the at least one electrical contact connects with the at least one electrical contact pad of the sensor assembly, where the sensor assembly and the transmitter assembly connect at one or more areas as a single unit in response to a rotating motion by a user.

In a further embodiment, the sensor assembly further includes a sensor extension coupled to the sensor base on a substantially centered location.

In a further embodiment, the sensor extension is an integral part of the sensor base of the sensor assembly.

In a further embodiment, the sensor extension includes a glucose sensor that monitors blood glucose levels in a diabetic patient.

In a further embodiment, the mounting base covers an entire outline of the bottom surface of the sensor base.

In a further embodiment, the electrical contact(s) disposed on the transmitter cap is solid and inflexible.

In a further embodiment, the device further includes a substantially symmetrical round shape.

In a further embodiment, the top surface of the sensor base further includes a sensor base cap extending therefrom that is substantially centered on the top surface of the sensor base.

In a further embodiment, the transmitter cap further comprises an opening substantially centered on the transmitter cap, wherein the opening is fitted to engage with the sensor base cap.

In a further embodiment, the one or more areas where the sensor assembly and the transmitter assembly connect are evenly spaced apart along an outline of the device.

In a further embodiment, the at least one interface that accommodates the sensor stack further includes a cavity disposed on the top surface of the sensor base.

In a further embodiment, the transmitter assembly further includes a wireless transmitter that communicates with a remote device.

In a further embodiment, the at least one electrical contact of the at least one electronics module of the transmitter cap further includes four charging or communications contacts.

In a further embodiment, the at least one electrical contact of the at least one electronics module of the transmitter cap further comprises six sensor contacts.

In a further embodiment, the six sensor contacts further comprise 1 reference electrode (RE), 1 counter electrode (CE) and 4 working electrodes (WE).

In a further embodiment, the at least one electrical contact of the at least one electronics module is substantially flush with a bottom surface of the transmitter cap.

In a further embodiment, the sensor base further includes at least one tab adapted to engage with at least one slot disposed on the transmitter cap to lock the sensor assembly and the transmitter assembly together axially.

In a further embodiment, the sensor base further includes at least one snap arm adapted to lock the transmitter assembly and the sensor assembly together rotationally.

In a further embodiment, the sensor base further includes at least one interface having at least one feature that matches at least one corresponding interface of the transmitter cap to lock the sensor assembly and the transmitter assembly together axially or rotationally.

In a further embodiment, the at least one interface of the sensor base further includes at least one slot having features that match the at least one corresponding interface of the transmitter cap.

In a further embodiment, the at least one corresponding interface of the transmitter cap further includes at least one rail.

In a further embodiment, the elastomeric connector further includes a top square cross section.

In a further embodiment, the elastomeric connector further includes a connector that includes alternating conductive and insulating regions.

In a further embodiment, the elastomeric connector further includes a ZEBRA connector.

In a further embodiment, the transmitter cap further includes a shell subassembly including a housing for a custom battery adjoining a substrate portion on which a PCB board is disposed, where the housing and the substrate portion are compressed to fit together without requiring solder or other connections.

In a further embodiment, the sensor assembly and the transmitter assembly include respective clocking features that do not have rotational symmetry and prevent the transmitter assembly from being connected to the sensor assembly in a particular orientation where the at least one electrical contact disposed on the transmitter cap does not align with the at least one electrical contact pad of the sensor assembly.

In a further embodiment, the clocking features further include at least one lug positioned along an outline of the transmitter cap and at least one corresponding opening positioned along an outline of the sensor base of the sensor assembly.

According to another embodiment, a device comprises: a sensor assembly including: a sensor base having a top surface and a bottom surface, and a mounting base having a first side that attaches to at least a portion of the bottom surface of the sensor base, and a second side that is adapted to adhere to a user's skin. The device also includes a transmitter assembly adapted to connect with the top surface of the sensor base of the sensor assembly, the transmitter assembly including: a transmitter shell and a transmitter cap having at least one interface adapted to engage with the sensor base; where the sensor assembly and the transmitter assembly connect at two compression areas as a single unit in response to a rotating motion by a user.

In a further embodiment, the two compression areas are automatically squeezed or compressed in response to the user applying the rotating motion in a first direction to lock the sensor assembly into place.

In a further embodiment, the sensor assembly and the transmitter assembly are disconnected in response to the user squeezing or compressing the two compression areas while applying a rotating motion in a second direction opposite from the first direction.

Sensor Connections

According to an embodiment, a sensor transmitter assembly includes: a sensor assembly including a sensor module where a first sensor including a first sensor head having at least one first sensor contact pad is combined with a second sensor including a second sensor head having at least one second sensor contact pad. The sensor transmitter assembly also includes a transmitter assembly positioned on a top of the sensor assembly to form a single unit, the transmitter assembly having at least one transmitter contact disposed on a base of the transmitter assembly, where the at least one first sensor contact pad and the at least one second sensor form a connection path with the at least one transmitter contact.

In a further embodiment, the first sensor and the second sensor are discrete single-sided sensors.

In a further embodiment, each of the first sensor and the second sensor includes 1 RE, 1 CE and 2 pairs of independent WE s that correspond to six contacts disposed on the base of the transmitter assembly.

In a further embodiment, each RE of the first sensor and the second sensor are shorted together and connected to a shared RE transmitter contact.

In a further embodiment, each CE of the first sensor and the second sensor are shorted together and connected to a shared CE transmitter contact.

In a further embodiment, each of the first sensor contact pads and the second sensor contact pads include a window cut therethrough.

In a further embodiment, the first sensor head and the second sensor head each have staggered windows cut through respective contact pads where at least one contact pad for each WE remains active.

In a further embodiment, each of the first sensor contact pads and the second sensor contact pads includes at least one trace leading to a respective electrode.

In a further embodiment, the trace(s) of each contact pad runs to a first side, where a contact pad is deactivated as a result of cutting a window on the first side of the contact pad.

In a further embodiment, the sensor module is assembled together before installation into a sensor base of the sensor assembly.

In a further embodiment, the first sensor head or the second sensor head further includes a sensor head extension on which at least one conducting pad is integrated.

In a further embodiment, the first sensor head or the second sensor head is adapted to be folded along a line that places the at least one conducting pad in contact with at least one contact pad.

In a further embodiment, the first sensor head further includes at least one conducting pad integrated on it.

In a further embodiment, the first sensor and the second sensor are interlaced, where a distal end of the first sensor is on top and the second sensor head is on bottom such that the second sensor contact pad(s) are placed against the conducting pad(s) integrated on the first sensor.

In a further embodiment, a signal from the at least one first sensor contact pad travels directly through an elastomeric connector to the at least one transmitter contact.

In a further embodiment, a signal from the at least one second sensor contact pad travels through the at least one conducting pad integrated on the first sensor head and through an elastomeric connector to the at least one transmitter contact.

According to another embodiment, a sensor transmitter assembly includes: a sensor module where a first sensor including a first sensor head having at least one first sensor contact pad is combined with a second sensor including a second sensor head having at least one second sensor contact pad, where the sensor module further includes a flex connector, where the first sensor and the second sensor are assembled to the flex connector. The sensor transmitter assembly also includes: a transmitter assembly positioned on a surface of the sensor module, the transmitter assembly having at least one transmitter contact disposed on a base of the transmitter assembly, where the at least one first sensor contact pad and the at least one second sensor form a connection path with the at least one transmitter contact.

In a further embodiment, the flex connector includes at least one conducting pad(s) that are isolated from each other, where the conducting pads of the flex connector conduct a signal from at least one of the first sensor contact pad(s) or the second sensor contact pad(s) to an elastomeric connector.

In a further embodiment, the flex connector further includes a double-sided adhesive on a top side and a bottom side, where the flex connector is adapted to be bonded to the first sensor and the second sensor on the top side and to a sensor base of the sensor assembly on the bottom side.

According to yet another embodiment, a method for connecting a sensor transmitter assembly includes: forming a back to back sensor combination for a sensor transmitter assembly including: creating windows through a first contact pad head of a first sensor where at least one window results in at least one active WE contact pad on the first sensor; creating windows through a second contact pad head of a second sensor where at least one window of the second contact pad results in at least one active WE contact pad on the second sensor, where the first sensor and the second sensor have mirrored window patterns across each respective contact pad head. The method also includes placing the first sensor back to back with the second sensor where the windows of the first sensor and the windows of the second sensor are aligned and provide a signal path between contact pads of the first contact pad head and the second contact pad head. The method further includes forming a sensor connector stack by placing the back to back sensor combination between a first elastomeric connector and a second elastomeric connector. And the method also includes connecting a transmitter assembly to the sensor assembly, where the sensor connector stack is compressed between at least one transmitter contact and a sensor base of the sensor assembly, where the signal path extends to the at least one transmitter contact.

Sensor Lockouts

According to an embodiment, a device includes: a sensor assembly having at least one sensor lockout having at least one feature particular to a generation of the sensor assembly; and a transmitter assembly having at least one transmitter lockout having at least one feature particular to a generation of the transmitter assembly, where the sensor assembly and the transmitter assembly connect with each other as a result of the at least one feature of the at least one sensor lockout matching the at least one feature of the transmitter lockout.

In a further embodiment, the sensor assembly and the transmitter assembly are functionally incompatible with each other, where the sensor assembly and the transmitter assembly do not connect with each other as a result of the at least one feature of the at least one sensor lockout not matching the at least one feature of the at least one transmitter lockout.

In a further embodiment, the at least one sensor lockout and the at least one transmitter lockout are included in an interchangeable mold insert adapted to be changed independently.

In a further embodiment, the at least one sensor lockout and the at least one transmitter lockout further include at least one slot and at least one rail on respective surfaces of the sensor assembly and the transmitter assembly that do not match and block the transmitter assembly from fully rotating onto and making a connection with a non-compatible sensor assembly.

In a further embodiment, the at least one sensor lockout and the at least one transmitter lockout further include at least one slot and at least one rail on respective surfaces of the sensor assembly and the transmitter assembly that match each other and allows the transmitter assembly to fully rotate onto and make a connection with a compatible sensor assembly.

In a further embodiment, the at least one feature particular to the generation of the sensor assembly and the at least one feature particular to the generation of the transmitter assembly further include at least one of a length, a width, a shape or a positioning.

In a further embodiment, the at least one feature particular to the generation of the sensor assembly further includes a placement along a predetermined diameter dimension on a sensor assembly surface, and the at least one feature particular to the generation of the transmitter assembly further includes a placement along a predetermined diameter dimension on a transmitter assembly surface.

According to another embodiment, a device comprises: a first assembly including a first interface, and a second assembly comprising a second interface, where the second assembly is incompatible for use with the first assembly, and where the first interface and the second interface block the first assembly from connecting with the incompatible second assembly.

In a further embodiment, the first interface and the second interface block the second assembly from fully rotating onto and making a connection with the incompatible second assembly.

In a further embodiment, the first interface and the second interface further include lockout features including at least one of a length, a width, a depth, a shape or a positioning on a corresponding first assembly or second assembly.

In a further embodiment, the first interface further includes a slot, and the second interface further includes a rail that does not match the slot.

In a further embodiment, the device includes an interchangeable mold insert adapted to be changed such that lockout features of the first interface or the second interface are changed.

In a further embodiment, the first interface and the second interface are located on respective noncritical surfaces of the first assembly and the second assembly.

According to yet another embodiment, a device comprises: a sensor assembly having sensor mechanical lockouts including a first sensor mechanical lockout feature and a second sensor mechanical lockout feature; and a transmitter assembly having transmitter mechanical lockouts, where the first sensor mechanical lockout feature defines a generation of the sensor assembly, and the second sensor mechanical sensor feature determines a generation of transmitter assembly that will fit with the sensor assembly.

In a further embodiment, the first sensor mechanical lockout feature includes a first slot and a second sensor mechanical lockout feature includes a second slot.

In a further embodiment, the transmitter mechanical lockouts further include at least one rail.

In a further embodiment, the transmitter mechanical lockouts further include a first transmitter mechanical lockout feature that defines a generation of the transmitter assembly, and a second transmitter mechanical lockout feature that determines which generation of sensor assembly will fit with the transmitter assembly.

In a further embodiment, the transmitter assembly initially engages with the sensor assembly by lowering down the transmitter assembly onto the sensor assembly and rotating the transmitter assembly on the sensor assembly, wherein the transmitter mechanical lockouts rotate through the sensor mechanical lockouts.

In a further embodiment, the second sensor mechanical lockout features match the transmitter mechanical lockouts so that full rotation of the transmitter mechanical lockouts is allowed and a connection is completed.

In a further embodiment, wherein the second sensor mechanical lockout features do not match the transmitter mechanical lockouts so that full rotation of the transmitter mechanical lockouts is prevented and a connection is not completed.

Duo

According to an embodiment, a device includes: a sensor transmitter assembly including a transmitter assembly placed on top of a sensor assembly to form a single unit, where a sensor portion extends from the sensor assembly and is adapted to be positioned in direct contact with a user's extracellular fluid. The device also includes an infusion set combined with the sensor transmitter assembly, where the infusion set is connected to a connection portion that extends from the sensor assembly, where a cannula extends from the infusion set, and the cannula is adapted to be introduced into a body of the user for infusing fluids.

In a further embodiment, the sensor portion extends from the sensor assembly from a substantially centered location.

In a further embodiment, the sensor assembly provides structural support to the sensor portion and facilitates entry into the body of the user.

In a further embodiment, the infusion set further includes an insertion conduit adapted to be connected to a reservoir or other supply device.

In a further embodiment, the device includes a mounting base for fastening the combined sensor transmitter assembly and infusion set, where the mounting base adheres to the user's skin.

In a further embodiment, the infusion set further includes a housing that engages with the connection portion, a septum, and a funnel.

In a further embodiment, the septum is compressed between the funnel and the connection portion.

In a further embodiment, when the housing is connected to the connection portion, the septum forms a radial seal around a needle contained in the housing, creating a sealed fluid path between tubing of the housing and the cannula, and the funnel compresses the cannula against the connection portion, where the cannula is mechanically retained within the connection portion, and a fluid tight seal is created between the funnel, the cannula, and the connection portion.

According to another embodiment, a combined sensor and infusion set include: a sensor assembly including a sensor extending from a substantially centered location on a bottom side of the sensor assembly; a connection portion extending from a base of the sensor assembly; and an infusion set including a cannula extending from a bottom side of the infusion set, a housing that engages with the connection portion, and a septum compressed between a funnel and the connection portion.

In a further embodiment, the combined sensor and infusion set include a transmitter assembly positioned on top of the sensor assembly as a single unit.

In a further embodiment, the sensor assembly provides structural support to the sensor and facilitates entry of the sensor into a body of a patient.

In a further embodiment, the cannula is adapted to be introduced into a body of a patient for infusing fluids to the patient.

In a further embodiment, the infusion set includes an insertion conduit adapted to be connected to a reservoir or other supply device.

In a further embodiment, the combined sensor and infusion set is fastened by a mounting base or patch that adheres to a patient's body.

In a further embodiment, when the housing is engaged, the septum forms a radial seal around a needle included in the housing, creating a sealed fluid path between tubing of the housing and the cannula.

In a further embodiment, the funnel compresses the cannula against the connection portion thus mechanically retaining the cannula within the connection portion and creating a fluid tight seal between the funnel, the cannula and the connection portion.

According to yet another embodiment, a combined sensor and infusion set include: a sensor assembly including a connector portion that extends from a portion of the sensor assembly, where the connection portion comprises a connector cap; and an infusion set including a cannula adapted to fittingly engage with the connector cap of the connection portion, where the sensor assembly and the infusion snap mechanically at at least one interface of the connection portion.

In a further embodiment, the at least one interface of the connection portion further includes at least one notch.

In a further embodiment, the sensor assembly and the infusion set snap mechanically as a result of a top down connection.

In a further embodiment, the combined sensor and infusion set further include a transmitter assembly positioned on top of the sensor assembly as a single unit.

Insertion Device

According to an embodiment, an insertion device includes: a plunger coupled with a lock collar, where the insertion device houses contents including at least one component including: a striker including at least one self-locking striker snap arm configured to keep the insertion device in a cocked position while not in use such that the striker is kept from firing by a striker spring captured between the plunger and the striker when the insertion is in the cocked position; a sensor assembly including a sensor disposed on a bottom surface of the sensor assembly, where a mounting base having a first side attaches to the bottom surface of the sensor assembly, and a second side of the mounting base is exposed; and a needle carrier adapted to hold a piercing member, the needle carrier captured between the striker and a needle carrier spring where at least one self-releasing snap keeps the needle carrier cocked, where the plunger prevents the self-releasing snap(s) from repositioning and releasing the needle carrier; such that when the insertion device is fired in response to a user depressing at least a portion of the plunger, the striker fires the needle carrier holding the piercing member such that the self-locking striker snap arm(s) are positioned to enter a groove to allow the striker to snap down, where after the insertion device is fired, the needle carrier is retracted in response to the user releasing the plunger such that the piercing member is encapsulated within the housing of the insertion device.

In a further embodiment, the insertion device is single use and disposable.

In a further embodiment, the insertion device includes a lid that completely covers a bottom surface of the lock collar to protect the contents within the insertion device.

In a further embodiment, the insertion device is unlocked by the user using two unlocking directional forces including performing a rotation motion while applying a downward force on the plunger to prevent the lock collar from accidentally unlocking.

In a further embodiment, the sensor assembly is fastened to a user's skin via the mounting base and the sensor is introduced into a body of the user upon firing of the needle carrier and the piercing member of the insertion device.

In a further embodiment, the sensor is introduced into a body of the user upon the user pushing on the plunger using a minimum pushing force for a certain minimum travel or distance.

In a further embodiment, the sensor assembly is automatically left behind on an insertion site upon the user pulling away the insertion device away from the insertion site after the insertion device is fired.

In a further embodiment, after the insertion device is used to insert the sensor extension into a body of a user, a transmitter assembly is connected to the sensor assembly at one or more areas as a single unit in response to a rotating motion by the user.

In another embodiment, a method for an insertion device mechanism includes: unlocking an insertion device that includes a plunger having at least one clearance slot coupled to a lock collar having at least one rib in response to a user rotating the plunger such that the clearance slot(s) align with the rib(s) of the lock collar; upon unlocking the insertion device, firing the insertion device at an insertion site in response to the user pressing the plunger; upon firing of the insertion device, causing a piercing member to insert a sensor of a sensor assembly into a body of the user and causing the sensor assembly to adhere to the body of the user; and retracting a needle carrier having the piercing member in response to the user releasing the plunger such that the piercing member is encapsulated inside the insertion device.

In a further embodiment, the firing the insertion device further includes compressing a striker spring in response to the user pressing the plunger wherein the rib(s) of the plunger deflect at least one self-locking striker snap arm.

In a further embodiment, once the sensor assembly is adhered to the body of the user, releasing the sensor assembly in response to the user pulling away the insertion device.

According to yet another embodiment, an insertion device includes: a plunger coupled to a lock collar, where the insertion device houses contents including: a striker; a sensor assembly; a needle carrier holding a piercing member, where, upon the insertion device being used or fired, the sensor assembly adheres to a user's body released from the insertion device in response to the user pulling away the insertion device, where the piercing member is retracted such that it is encapsulated inside the insertion device; and where a piercing member protection mechanism is adapted to prevent the insertion device from being fully depressed again once it has been used or fired. The piercing member protection mechanism includes: at least one cam rail disposed on an inner surface of the needle carrier; at least one outer guide rail disposed on an outer surface of the needle carrier; at least one guide slot disposed on an inner wall of the striker; a shaft extending from a top surface of the plunger, the shaft including a cammed surface that includes at least one locking slot from a first end proximate to the top surface of the plunger and extending along a surface of the shaft into a corresponding cam. During insertion of the insertion device into the user's body, the guide rail(s) of the needle carrier fit inside the guide slot(s) of the striker. After insertion, and during retraction of the needle carrier, the guide slot(s) of the striker guide the needle carrier. And where, as the needle carrier continues to retract, the needle carrier pulls free from the striker and is guided by the cammed surface of the shaft of the plunger such that the cam rail(s) of the needle carrier contact the corresponding cam of the plunger; and where once the needle carrier is fully retracted into the insertion device, the locking slot(s) of the shaft of the plunger engage the cam rail(s) of the needle carrier, permanently locking the retracted needle carrier into a rotated position.

In a further embodiment, the needle carrier includes two outer guide rails on opposite sides along an outer surface of the needle carrier.

In a further embodiment, the striker includes two guide slots disposed on opposite sides along an outline of an inner surface or wall of the striker.

In a further embodiment, when the cam rail(s) of the needle carrier contact the corresponding cam of the plunger, the needle carrier rotates in a direction guided by the corresponding cam.

In a further embodiment, the corresponding cam of the plunger includes an angle that guides the needle carrier along the angle.

In a further embodiment, the angle of the corresponding cam is approximately 60 degrees.

In a further embodiment, the needle carrier further includes a spring that holds the fully retracted needle carrier against the plunger.

In a further embodiment, when the needle carrier is permanently locked into the rotated position, the outer guide rail(s) of the needle carrier do not line up with the guide slot(s) of the striker.

In a further embodiment, the outer guide rail(s) of the needle carrier interfere with at least a portion of a top surface of the striker such that the needle carrier acts as a barrier between the plunger and the striker thus preventing the plunger and the striker from being fully depressed keeping a tip of the piercing member protected within the insertion device.

Other features and advantages of the embodiments of the present disclosure will become apparent from the following detailed description, taken in conjunction with the accompanying drawings which illustrate, by way of example, various features of embodiments of the present disclosure.

BRIEF DESCRIPTION OF THE DRAWINGS

A more complete understanding of the embodiments of the present disclosure may be derived by referring to the detailed description and claims when considered in conjunction with the following figures, where like reference numbers refer to similar elements throughout the figures.

FIG. 1A is a top view of a sensor transmitter assembly as a single unit having at least one outer edge according to an embodiment of the present disclosure;

FIG. 1B is a side view of the sensor transmitter assembly ofFIG. 1A according to an embodiment of the present disclosure;

FIG. 2A is an exploded top perspective view of the sensor transmitter assembly illustrated inFIGS. 1A and 1B according to an embodiment of the present disclosure;

FIG. 2B is an exploded bottom perspective view of the sensor transmitter assembly illustrated inFIGS. 1A and 1B according to an embodiment of the present disclosure;

FIGS. 3A-3C illustrate side perspective views for mechanically connecting a sensor assembly to a transmitter assembly according to an embodiment of the present disclosure;

FIG. 4 is an exploded view of a sensor assembly according to an embodiment of the present disclosure;

FIGS. 5A-5C illustrate views for affixing a sensor head and an elastomeric connector to a sensor base of a sensor assembly according to an embodiment of the present disclosure;

FIG. 6 is a partial top perspective view of a sensor assembly according to an embodiment of the present disclosure;

FIGS. 7A-7C illustrate views of an interface for a sensor assembly including a sensor base, a sensor portion, a needle, a pedestal base and a pedestal cap according to an embodiment of the present disclosure;

FIG. 7D is a partial side perspective view of a sensor assembly showing an interface of a sensor portion, a sensor base, a needle and a pedestal cap according to an embodiment of the present disclosure;

FIG. 7E is a detail of the interface illustrated inFIG. 7D according to an embodiment of the present disclosure;

FIG. 8 illustrates a sensor transmitter assembly with seals that improve water tightness according to an embodiment of the present disclosure;

FIG. 9 is an exploded view of a transmitter assembly according to an embodiment of the present disclosure;

FIG. 10A is a bottom side perspective view of a transmitter shell subassembly according to an embodiment of the present disclosure;

FIG. 10B is a top side perspective view of a transmitter shell subassembly according to an embodiment of the present disclosure;

FIG. 11A is a partial plane view of a transmitter assembly layout according to an embodiment of the present disclosure;

FIG. 11B is another partial plane view of a transmitter assembly according to an embodiment of the present disclosure;

FIG. 11C is a partial perspective view of a transmitter assembly layout illustrating details of external contacts to a PCB according to an embodiment of the present disclosure;

FIGS. 12A-D are perspective views of transmitter cap contacts overmolding according to an embodiment of the present disclosure;

FIG. 13 illustrates side perspective views for electrically connecting a sensor assembly to a transmitter assembly according to an embodiment of the present disclosure;

FIG. 14 is a partial top view of an electrical connection of a sensor assembly and at least one contact of a transmitter assembly according to an embodiment of the present disclosure;

FIG. 15A is a partial top side perspective view of a back-to-back sensor connection according to an embodiment of the present disclosure;

FIG. 15B is a partial bottom side perspective view of a back-to-back sensor connection according to an embodiment of the present disclosure;

FIG. 15C is a partial top view of a bottom surface of a transmitter assembly according to an embodiment;

FIG. 16 is a top view of a sensor having at least one contact pad according to an embodiment of the present disclosure;

FIG. 17 is a top view of a sensor having windows cut through each of the sensor contact pads according to an embodiment of the present disclosure;

FIG. 18 illustrates a back-to-back sensor combination according to an embodiment of the present disclosure;

FIGS. 19A-19C illustrate views for placing a first sensor and a second sensor back to back and creating a signal path according to an embodiment of the present disclosure;

FIG. 20 illustrates a back-to-back sensor connection to a transmitter assembly according to an embodiment of the present disclosure;

FIG. 21 illustrates a back-to-back sensor disposed in between elastomeric connectors according to an embodiment of the present disclosure;

FIG. 22 is a partial side perspective view of a sensor transmitter assembly having a back-to-back sensor connected to a transmitter according to an embodiment of the present disclosure;

FIG. 23 is a perspective view of a connection between sensor contact pads and transmitter contacts according to an embodiment of the present disclosure;

FIG. 24 is a bottom perspective view of a connection of a sensor contact pad to a transmitter contact according to an embodiment of the present disclosure;

FIG. 25 illustrates a detailed connection of at least one sensor contact pad to a transmitter contact according to an embodiment of the present disclosure;

FIG. 26 illustrates a connection of a CE or RE to a transmitter contact according to an embodiment of the present disclosure;

FIGS. 27A-27C are views of a first sensor and a second sensor having mirrored contact pads and respective connections to a transmitter according to an embodiment of the present disclosure;

FIG. 28 illustrates perspective side views of a sensor assembly and a transmitter assembly having mechanical lockouts according to an embodiment of the present disclosure;

FIGS. 29A-29B are top views of a sensor transmitter assembly having mechanical lockouts according to an embodiment of the present disclosure;

FIGS. 30A-30B are top views of a sensor transmitter assembly with mechanical lockouts according to another embodiment of the present disclosure;

FIGS. 31A-31B are top views of a sensor transmitter assembly with mechanical lockouts according to yet another embodiment of the present disclosure;

FIGS. 32A-32B illustrate lockouts for different generations of a transmitter assembly and a sensor assembly according to an embodiment of the present disclosure;

FIGS. 33A-33B illustrate lockouts for different generations of transmitter assemblies and sensor assemblies according to another embodiment of the present disclosure;

FIGS. 34A-34B illustrate lockouts for different generations of transmitter assemblies and sensor assemblies according to yet another embodiment of the present disclosure;

FIG. 35 illustrates top views of different generations of sensor and transmitter assemblies with different mechanical lockouts according to an embodiment of the present disclosure;

FIG. 36 illustrates top views of different generations of sensor and transmitter assemblies with different mechanical lockouts according to another embodiment of the present disclosure;

FIG. 37 illustrates perspective views of sensor assemblies and transmitter assemblies with different lockout features according to an embodiment of the present disclosure;

FIG. 38 is a top view of a sensor transmitter assembly with aligned contacts according to an embodiment of the present disclosure;

FIG. 39 is a top view of a sensor transmitter assembly with non-aligned contacts according to an embodiment of the present disclosure;

FIG. 40 illustrates top views of a sensor assembly and a transmitter assembly having features that do not have rotational symmetry according to an embodiment of the present disclosure;

FIGS. 41A-41C illustrate perspective views of a sensor assembly and a transmitter assembly having clocking features according to an embodiment of the present disclosure;

FIGS. 42A-42B illustrate perspective views of a sensor assembly and a transmitter assembly having clocking features according to another embodiment of the present disclosure;

FIG. 43 is a flowchart illustrating a method for forming a sensor transmitter assembly according to an embodiment of the present disclosure;

FIG. 44 is a flowchart illustrating a method for connecting a sensor transmitter assembly according to an embodiment of the present disclosure;

FIG. 45A is a perspective outer view of a single-use, disposable insertion tool according to an embodiment of the present disclosure;

FIG. 45B is a perspective inner view of the single-use, disposable insertion tool ofFIG. 45A according to an embodiment of the present disclosure;

FIGS. 46A-46B are bottom perspective views of an insertion device illustrating a first step for a use model of the insertion device according to an embodiment of the present disclosure;

FIGS. 47A-47B are perspective views of an insertion device illustrating a second step for a use model of the insertion device according to an embodiment of the present disclosure;

FIG. 48 is a perspective view of an insertion device illustrating a third step for a use model of the insertion device according to an embodiment of the present disclosure;

FIGS. 49A-49B are perspective views of an insertion device illustrating a fourth step for a use model of the insertion device according to an embodiment of the present disclosure;

FIGS. 50A-50B are perspective views for unlocking an insertion device according to an embodiment of the present disclosure;

FIG. 51 is a cutout view of the insertion device ofFIGS. 50A-50B in a cocked position according to an embodiment of the present disclosure;

FIGS. 52A-52B are cutout views of the insertion device ofFIGS. 50A-50B in an insertion position according to an embodiment of the present disclosure;

FIGS. 53A-53B are cutout views of the insertion device ofFIGS. 50A-50B in a retraction position according to an embodiment of the present disclosure;

FIG. 54 is a cutout view of the insertion device ofFIGS. 50A-50B in a released position according to an embodiment of the present disclosure;

FIG. 55 is a flow chart illustrating a method for an insertion device mechanism according to an embodiment of the present disclosure;

FIG. 56A is a top view of a sensor transmitter assembly as a single unit having two compression areas according to an alternative embodiment of the present disclosure;

FIG. 56B is a side view of the sensor transmitter assembly ofFIG. 56A according to an embodiment of the present disclosure;

FIG. 57A is an exploded top perspective view of the sensor transmitter assembly illustrated inFIGS. 56A and 56B according to an alternative embodiment of the present disclosure;

FIG. 57B is an exploded bottom perspective view of the sensor transmitter assembly illustrated inFIGS. 56A and 56B according to an embodiment of the present disclosure;

FIGS. 58A-58C illustrate side perspective views for mechanically connecting a sensor assembly to a transmitter assembly according to an alternative embodiment of the present disclosure;

FIG. 59 is an exploded view of a sensor assembly according to an alternative embodiment of the present disclosure;

FIGS. 60A-60C illustrate views for affixing a sensor head and an elastomeric connector to a sensor base of a sensor assembly according to an alternative embodiment of the present disclosure;

FIG. 61 is a partial top perspective view of a sensor assembly according to an alternative embodiment of the present disclosure;

FIGS. 62A-62C illustrate views of an interface for a sensor assembly including a sensor base, a sensor portion, a piercing member or needle, a pedestal base and a pedestal cap according to an alternative embodiment of the present disclosure;

FIG. 62D is a partial side perspective view of a sensor assembly showing an interface of a sensor portion, a sensor base, a piercing member or needle and a pedestal cap according to an alternative embodiment of the present disclosure;

FIG. 62E is a detail of the interface illustrated inFIG. 62D according to an alternative embodiment of the present disclosure;

FIG. 63 is a perspective view of a sensor transmitter assembly with seals that improve water tightness according to an alternative embodiment of the present disclosure;

FIG. 64 is an exploded view of a transmitter assembly according to an alternative embodiment of the present disclosure;

FIG. 65A is a bottom side perspective view of a transmitter shell subassembly according to an alternative embodiment of the present disclosure;

FIG. 65B is a top side perspective view of a transmitter shell subassembly according to an alternative embodiment of the present disclosure;

FIG. 66A is a partial plane view of a transmitter assembly layout according to an alternative embodiment of the present disclosure;

FIG. 66B is another partial plane view of a transmitter assembly according to an alternative embodiment of the present disclosure;

FIG. 66C is a partial perspective view of a transmitter assembly layout illustrating details of external contacts to a PCB according to an alternative embodiment of the present disclosure;

FIG. 67 illustrates side perspective views for electrically connecting a sensor assembly to a transmitter assembly according to an alternative embodiment of the present disclosure;

FIG. 68 is a partial top view of an electrical connection of a sensor assembly and at least one contact of a transmitter assembly according to an embodiment of the present disclosure;

FIG. 69A is an exploded top view of a sensor module having a back to back sensor connection with a rigid flex connector according to an embodiment of the present disclosure;

FIG. 69B is an exploded bottom view of the sensor module ofFIG. 69A according to an embodiment of the present disclosure;

FIG. 70A is a perspective top view of a sensor module having a back to back sensor connection with a rigid flex connector according to an embodiment of the present disclosure;

FIG. 70B is a perspective bottom view of the sensor module ofFIG. 70A according to an embodiment of the present disclosure;

FIG. 71A is a perspective bottom view of a flex circuit according to an embodiment of the present disclosure;

FIG. 71B is a perspective top view of the flex circuit ofFIG. 71A according to an embodiment of the present disclosure;

FIGS. 72A-72D illustrate an assembly process for a sensor module according to an embodiment of the present disclosure;

FIGS. 73A-73B illustrate a sensor module installed in a sensor subassembly according to an embodiment of the present disclosure;

FIG. 74 illustrates a signal path to a transmitter from a lower sensor according to an embodiment of the present disclosure;

FIG. 75 illustrates a signal path to a transmitter from an upper sensor according to an embodiment of the present disclosure;

FIG. 76 illustrates a perspective view of a lower sensor with conducting pads and an integrated flex connector according to an embodiment of the present disclosure;

FIGS. 77A-77D illustrate perspective views for assembling the lower sensor ofFIG. 76 according to an embodiment of the present disclosure;

FIG. 78 illustrates a signal path to a transmitter from the lower sensor having an integrated flex connector illustrated inFIGS. 76 and 77A-D according to an embodiment of the present disclosure;

FIG. 79A is an exploded top view of a sensor module having conducting pads integrated into a sensor according to an alternative embodiment of the present disclosure;

FIG. 79B is an exploded bottom view of the sensor module ofFIG. 79A according to an alternative embodiment of the present disclosure;

FIG. 80A is a perspective top view illustrating a sensor module with sensor interlacing of the first and second sensors according to an embodiment of the present disclosure;

FIG. 80B is a perspective bottom view of the sensor module ofFIG. 80A according to an embodiment of the present disclosure;

FIG. 81 illustrates a signal path to a transmitter from a first sensor having an integrated flex connector that is interlaced with a second sensor as illustrated inFIGS. 80A-80B according to an embodiment of the present disclosure;

FIG. 82 illustrates a signal path to a transmitter from a second sensor that is interlaced with a first sensor as illustrated inFIGS. 80A-80B according to an embodiment of the present disclosure;

FIG. 83A is a top orthogonal view of a combined sensor and infusion set according to an embodiment of the present disclosure;

FIG. 83B is a front orthogonal view of the combined sensor and infusion set ofFIG. 69A according to an embodiment of the present disclosure;

FIG. 83C is a side orthogonal view of the combined sensor and infusion set ofFIG. 69A according to an embodiment of the present disclosure;

FIG. 83D is a back orthogonal view of the combined sensor and infusion set ofFIG. 69A according to an embodiment of the present disclosure;

FIG. 83E is a bottom orthogonal view of the combined sensor and infusion set ofFIG. 69A according to an embodiment of the present disclosure;

FIG. 84A is an isometric perspective front view of a combined sensor and infusion set according to an embodiment of the present disclosure;

FIG. 84B is an isometric perspective back view of the combined sensor and infusion set ofFIG. 84A according to an embodiment of the present disclosure;

FIG. 84C is an isometric perspective bottom view of the combined sensor and infusion set ofFIG. 84A according to an embodiment of the present disclosure;

FIG. 85 is a section view of a combined sensor and infusion set according to an embodiment of the present disclosure;

FIG. 86A illustrates a perspective view of a connection for a sensor and infusion set according to an embodiment of the present disclosure;

FIG. 86B illustrates a front view of a connection for a sensor and infusion set according to an embodiment of the present disclosure;

FIG. 86C illustrates a back view of a connection for a sensor and infusion set according to an embodiment of the present disclosure;

FIG. 86D illustrates a perspective view of a combined sensor infusion set as a result of a top down connection according to an embodiment of the present disclosure;

FIG. 86E illustrates a detail of a back surface view of a combined sensor infusion set according to an embodiment of the present disclosure;

FIG. 87A illustrates a used insertion device according to an embodiment of the present disclosure;

FIG. 87B illustrates the used insertion device ofFIG. 87A with a depressed plunger and striker according to an embodiment of the present disclosure;

FIG. 88 illustrates a cutout section view of an insertion device having a piercing member protection mechanism according to an embodiment of the present disclosure;

FIG. 89A illustrates a section view of an insertion device having a piercing member protection mechanism including a needle carrier disposed therein according to an embodiment of the present disclosure;

FIG. 89B illustrates a perspective view of the needle carrier ofFIG. 89A according to an embodiment of the present disclosure;

FIG. 89C illustrates a top view of the needle carrier ofFIGS. 89A and 89B according to an embodiment of the present disclosure;

FIG. 90A illustrates a section view of an insertion device having a piercing member protection mechanism including a striker disposed therein according to an embodiment of the present disclosure;

FIG. 90B illustrates a perspective view of the striker ofFIG. 90A according to an embodiment of the present disclosure;

FIG. 90C illustrates a top view of the striker ofFIGS. 90A and 90B according to an embodiment of the present disclosure;

FIG. 91A illustrates a section view of an insertion device having a piercing member protection mechanism including a plunger according to an embodiment of the present disclosure;

FIG. 91B illustrates a perspective view of the plunger ofFIG. 90A according to an embodiment of the present disclosure;

FIG. 91C illustrates a section view cutout along line A-A′ of the striker ofFIG. 91B according to an embodiment of the present disclosure;

FIG. 92A illustrates a section view of an insertion tool having a piercing member protection mechanism that has not been used or fired according to an embodiment of the present disclosure;

FIG. 92B illustrates a section view of an insertion tool having a piercing member protection mechanism during insertion according to an embodiment of the present disclosure;

FIG. 92C illustrates a top section view of a needle carrier and a striker of the insertion tool ofFIG. 92B during insertion according to an embodiment of the present disclosure;

FIG. 93A is a section view illustrating a first half of a retraction of a needle carrier of an insertion tool having a piercing member protection mechanism according to an embodiment of the present disclosure;

FIG. 93B illustrates a top section view of a needle carrier and a striker of the insertion tool ofFIG. 93A during retraction according to an embodiment of the present disclosure;

FIG. 94A illustrates a section view of an insertion tool having a piercing member protection mechanism with a needle carrier retracted about halfway into a top portion of the insertion tool according to an embodiment of the present disclosure;

FIG. 94A-1 illustrates a top view of the needle carrier retracted about halfway into the top portion of the insertion tool ofFIG. 94A according to an embodiment of the present disclosure;

FIG. 94B illustrates a section view of an insertion tool having a piercing member protection mechanism with a needle carrier substantially in mid rotation within the insertion tool according to an embodiment of the present disclosure;

FIG. 94B-1 is a top section view illustrating the needle carrier substantially in mid rotation within the insertion tool ofFIG. 94B;

FIG. 94C illustrates a section view of an insertion tool having a piercing member protection mechanism with a needle carrier fully retracted and rotated within the insertion tool according to an embodiment of the present disclosure;

FIG. 94C-1 is a top section view of the needle carrier fully retracted and rotated within the insertion tool ofFIG. 94C;

FIGS. 95A-95C illustrate section views of a locking or piercing member protection mechanism for an insertion tool according to one or more embodiments of the present disclosure; and

FIG. 96 illustrates a section view of a used or fired inserter tool having a locking or piercing member protection mechanism with a plunger and striker depressed according to an embodiment of the present disclosure.

DETAILED DESCRIPTION

Embodiments of the present disclosure generally relate to the design and arrangement techniques of a medical device, component or product. In particular, embodiments relate to a device, component or product that includes a sensor (e.g., an analyte sensor) and a transmitter. In various embodiments, an analyte sensor may refer to, without limitation, a substance or chemical constituent in a biological fluid (e.g., blood, interstitial fluid, cerebral spinal fluid, lymph fluid or urine) that can be analyzed. Non-limiting exemplary embodiments are described below that may relate to a continuous glucose sensor and transmitter of the type used by diabetic patients. It should be appreciated that the design and arrangement techniques described according to one or more embodiments are not limited for use with glucose sensors. Indeed, the concepts and technology described with reference to glucose sensors may also be used with other medical devices, components or products, other sensor types, other medical supplies, or the like.

According to one or more embodiments of the present disclosure, a device or product having a platform including a new design and arrangement technique of placing a transmitter on top of a sensor, for example, for use in the indication or monitoring of blood glucose levels in a diabetic patient, may address issues created by conventional platforms having a sensor and a transmitter placed side-by-side. For example, platforms according to one or more embodiments address issues and provide benefits to a patient (also referred to as “user”) including increased on-body device stability, increased robustness of connection, improved on-body comfort during wear, a simplified use model, etc. Likewise, platforms according to one or more embodiments provide opportunities to resolve issues associated with device performance or assembly including, for example, sensor pullouts or pullups, adhesion to the body, disconnects (e.g., electrical, mechanical, RF, etc.), damage to transmitter pins or contacts, adhesive backfill, cap/needle interference, and cost reduction.

As such, a device having a sensor transmitter assembly according to one or more embodiments of the present disclosure has many features that provide many benefits to a patient as well as to performance and assembly of the device. Below are listed various non-limiting features of a device according to one or more embodiments along with corresponding benefits.

1) A large mounting base—a device according to one or more embodiments includes a transmitter assembly positioned on a first surface or base of a sensor assembly. A first side of a mounting base is disposed on a second or bottom surface of the sensor assembly. A second side of the mounting base attaches to a user's skin. In one or more embodiments, the mounting base is large enough to cover an entire outline of the sensor assembly so that an external load applied to the device is distributed across the large surface area, thus increasing on-body stability and comfort and minimizing the need for other inconvenient attachment techniques such as overtape. Increased on-body stability leads to increased sensor accuracy. In embodiments where the mounting base includes a large stretchy pad, items such as clothing are not caught between the patch and the user's skin.

2) A low profile and reduced volume—the arrangement techniques for the sensor transmitter assembly according to one or more embodiments such as positioning a transmitter assembly on top of a sensor assembly, as opposed to side by side, allow the assembly to have a low profile. A low profile increases on-body stability, on-body comfort and is aesthetically better than a larger device with a higher profile. A patient avoids issues associated with larger devices such as bulkiness, lack of comfort, potential device visibility under clothes, etc. In addition, the transmitter components are arranged more efficiently, allowing for a significant size reduction over conventional platforms or devices.

3) A centered sensor—a device having a sensor transmitter assembly according to one or more embodiments has a substantially round shape where a sensor is positioned substantially in the center of the device. As a result, on-body stability is improved because the sensor is positioned, for example, in the center of a patch that attaches to a patient's body. Also, the use model is simple for a patient when introducing the sensor into the body.

4) Multi-point connection—in one or more embodiments, a device having a sensor assembly that connects with a transmitter assembly at multiple points (e.g., 2, 3, etc. points) along an outline of the device provides connection robustness and use model simplicity. In that regard, the multi-point connections make the attachment stronger without increasing difficulty for connecting to a user. Multi point connections are generally stronger than, for example, having only one connection point.

5) Solid transmitter contacts—a mechanical interface between a sensor and a transmitter is robust, preventing disconnects such as electrical disconnects. In one or more embodiments, because the transmitter is a durable device, electrical contacts on the transmitter are solid and inflexible, thus increasing the robustness of the contacts. Furthermore, the transmitter contacts are not inside the transmitter assembly but instead, they are substantially flush with a bottom surface of the transmitter, which provides easy access for cleaning and avoids potential corrosion of the contacts.

6) Elastomeric sensor contacts—because the sensor is disposable, flexible electrical contacts, which are more prone to damage, can be used in the sensor. In various embodiments, elastomeric gaskets create a mechanical seal of a sensor substrate path, thus eliminating the need for a fluid seal, for example an adhesive seal. As such, a fluid seal is replaced by a more reliable mechanical seal.

7) Smooth, continuous surfaces and edges—a device according to one or more embodiments has smooth, continuous surfaces and edges that improve on-body comfort and aesthetics. A patient avoids having to wear a device with uncomfortable pointy or rough surfaces or edges. Smooth surfaces and edges can also be better concealed under clothing without potential snagging or visibility.

8) Radial symmetry and no-look twist connection—in one or more embodiments, radial symmetry provides use model simplicity and better aesthetics. Connection and disconnection between the transmitter and the sensor are intuitive to a patient. For example, the patient can connect (or disconnect) the transmitter to the sensor through an intuitive twisting motion. The patient can connect (or disconnect) the transmitter and the sensor single-handedly without the patient having to look at the device, thus enabling the device to be worn in more locations on the patient's body. That is, the patient can easily connect or disconnect the transmitter to the sensor even in body locations where the patient does not have visibility, for example, on the patient's back.

In addition, according to one or more embodiments of the present disclosure, mechanical lockouts between non-compatible transmitter/sensor combinations may be made easily through, for example, interchangeable mold inserts. In certain embodiments, it is likely that some generations of devices or products include a transmitter assembly and a sensor assembly that are functionally incompatible with each other. For example, a device includes a transmitter assembly using a new transmitter algorithm paired with an older sensor assembly. In some embodiments, it is necessary to provide ways to prevent incompatible transmitter assemblies and sensor assemblies from connecting to each other both mechanically and electrically. One or more embodiments allow lockouts to prevent incompatible transmitter and sensor assemblies from connecting. The lockouts are changed easily and independently of other potentially critical features. In an embodiment, slots and rails on respective sensor or transmitter assemblies are used to block a transmitter from fully rotating onto and making a connection with a non-compatible sensor.

It should be noted that a device can include components having a combination of one or more features as described according to one or more embodiments, and the features are interchangeable between components of the device.

In addition, one or more embodiments relate to a single-use, disposable insertion device or product that includes a sensor (e.g., an analyte sensor), an insertion needle and related packaging into the one combined single-use, disposable device. It should be appreciated that the design and arrangement techniques of the insertion device described according to one or more embodiments are not limited for use with glucose sensors. Indeed, the concepts and technology described with reference to glucose sensors may also be used with other medical devices, products, components, supplies, other sensor types, or the like.

While current platforms use multiple-use, durable insertion devices, which makes for a complex use model of the insertion devices requiring many steps and fine motor skills as well as being prone to wear and damage, platforms according one or more embodiments of the present disclosure integrate a sensor, an insertion needle, a needle hub and sensor packaging into an all-in-one, single-use disposable device with a greatly simplified use model. In that regard, an insertion device according to one or more embodiments of the present disclosure reduces the number of steps for insertion, makes those steps simple and intuitive, and requires only gross motor skills for the user. This increases the likelihood of successful insertion and reduces the number of replacement sensors needed by users. Also, it decreases the need for in-depth training such as in-person training on how to use the device. Furthermore, because insertion devices according to one or more embodiments are single-use, the need for disinfection or cleaning in a clinical setting is eliminated.

While current platforms require users to carry packaged sensors plus a separate insertion device such that users cannot insert a sensor if the user does not have the insertion device, embodiments of the present disclosure allow users to carry only one device. For example, users only need to carry one device instead of carrying both, packaged sensors and an insertion device. This results in less waste that needs to be disposed after each insertion.

An insertion device according to one or more embodiments provides tension-loaded, e.g., spring-loaded, sensor insertion into the body of a user. To remove a needle after insertion of the sensor, the device automatically retracts the tension-loaded, e.g., spring-loaded needle in response to the user pulling the insertion device away from the body. The device also shields the used needle to prevent accidental needle sticks or other potential safety or hygiene issues. Also, in various embodiments, the device includes a locking mechanism to prevent it from being accidentally fired during various handling stages such as transportation, storage, etc.

In one or more embodiments, the insertion device is axially symmetrical, thus eliminating the need for the user to orient the device to the body in a particular way during insertion. Also, the device can be used one-handed such that the user utilizes it without looking. This enables the sensor to be easily inserted in hard-to-reach places such as the back of the arm. The firing mechanism of the insertion device guarantees that sufficient pressure is applied to the insertion site, which ensures full needle insertion and sensor adhesion to the skin of the user.

According to one or more embodiments, after the insertion device has been used or fired, for example to insert a sensor into the body of a user, and the needle has been retracted back into an inner volume of the insertion device, a needle protection mechanism is used to prevent the needle from being exposed by preventing a plunger and a striker of the insertion device from being fully depressed again. Advantageously, the needle is protected from exposure without adding excessive volume to the insertion device.

Overview of Device with Sensor/Transmitter Assembly

FIG. 1A is a top view of a sensor transmitter assembly as a single unit according to an embodiment of the present disclosure.FIG. 1B is a side view of the sensor transmitter assembly ofFIG. 1A according to an embodiment of the present disclosure.

FIG. 1A andFIG. 1B illustrate asensor transmitter assembly100 as a single unit as may be worn on-body by a patient.Sensor transmitter assembly100 may be fastened by a mounting base or patch102 that adheres to the patient's skin. As illustrated in the embodiment ofFIG. 1A, thesensor transmitter assembly100 may have a substantially symmetrical round shape. Radial symmetry of thesensor transmitter assembly100 avoids having to orient the assembly in a certain way on the patient's body, as compared to, for example, other shapes such as rectangular shapes that may require a certain orientation on the body. The shape of thesensor transmitter assembly100 according to one or more embodiments has smooth outer edges, which prevent potential wear issues such as snagging on the patient's clothing that may be caused by, for example, sharp, pointy edges. Also, smooth footprint edges help improve comfort of wear.

As illustrated in the embodiment ofFIG. 1B,sensor transmitter assembly100 includes atransmitter assembly106 positioned on top of asensor assembly112.Transmitter assembly106 andsensor assembly112 attach at one or more edges or points, for example at threeouter edges126 that are spaced apart, for example, evenly spaced apart around an outline of the sensor transmitter assembly. It should be noted thattransmitter assembly106 andsensor assembly112 may attach at any number of points or edges as appropriate, for example, at three edges as illustrated inFIG. 1A, or at 2 edges, 4 edges, 5 edges, etc. A sensor extension orportion104 is coupled to a sensor base ofsensor assembly112 on a substantially centered location.Sensor portion104 may be an integral part of the sensor base ofsensor assembly112. The sensor base ofsensor assembly112 provides structural support tosensor portion104 and facilitates entry ofsensor portion104 into the body of the patient.Sensor portion104 may be introduced into the body of the patient using a needle. In various embodiments, the needle and thesensor assembly112 may be pre-connected as part of a sensor set. In other embodiments, the needle,sensor assembly112, andsensor portion104 may be packaged and provided together. In further embodiments, a disposable insertion device, which is an integrated, single unit device (for example as described below according to one or more embodiments with respect toFIGS. 45A-55), allows the user to position and subcutaneously implant a sensor into the user's body. As such, in various embodiments,sensor portion104 may be positioned subcutaneously/transcutaneously in direct contact with a patient'sextracellular fluid101.

In various embodiments,sensor portion104 is an electrochemical sensor that includes a glucose oxidase enzyme, as known in the art by those familiar with glucose sensor technology. The glucose oxidase enzyme enablessensor portion104 to monitor blood glucose levels in a diabetic patient by effecting a reaction of glucose and oxygen. It should be understood that although one or more embodiments relate to glucose sensors, the concepts and technology described herein may be adapted for use with any one of a wide variety of sensors known in the art.

Alternative embodiments for a sensor transmitter assembly are illustrated in at leastFIGS. 56A-56B, 57A-57B, 58A-58C, which will be described in more detail below, where a sensor transmitter assembly is shown having two compression areas instead of one or more outer edges (e.g., 3outer edges126 as illustrated inFIG. 1A andFIG. 1B). For example, two

compression areas

142a,142billustrated inFIGS. 56A and 56B for a sensor transmitter assembly shown as a single unit allow a user to easily rotate in a first direction the transmitter assembly onto the sensor assembly in order to lock the sensor assembly to the transmitter assembly. To unlock the transmitter assembly from the sensor assembly, the user can easily press or squeeze at the compression areas while rotating in an opposite second direction. This provides a double fail safe mechanism (e.g., simultaneously squeezing and rotating) that is easy and intuitive for a user.

FIG. 2A is an exploded top perspective view of thesensor transmitter assembly100 illustrated inFIGS. 1A and 1B according to an embodiment of the present disclosure.FIG. 2B is an exploded bottom perspective view of thesensor transmitter assembly100 illustrated inFIGS. 1A and 1B according to an embodiment of the present disclosure. As illustrated inFIGS. 1A and 1B, the components of thesensor transmitter assembly100 may be coupled together as a single unit.

The embodiment ofFIG. 2A illustrating an exploded top view of the sensor transmitter assembly generally includes atransmitter assembly106 and asensor assembly112.Sensor assembly112 includes electrical and physical interfaces and elements that accommodate an electronics module that includes at least oneelectronics component208 as will be described in more detail below for example at least with respect to the embodiment ofFIG. 4. At least oneelectronics component208 is disposed on a cavity of asensor base219 ofsensor assembly112. A mounting base orpatch102 is attached to an entire bottom surface or outline ofsensor assembly112.Transmitter assembly106 includes anopening216 that is adapted to engage with acap209 ofsensor assembly112. In that regard,transmitter assembly106 is initially lowered intosensor assembly112 such thatopening216 oftransmitter assembly106 is positioned to fitcap209 ofsensor assembly112. A solid connection oftransmitter assembly106 tosensor assembly112 is completed by an intuitive rotation motion as will be described in more detail below.

In certain embodiments, portions of the sensor transmitter assembly are formed at least in part of a plastic material. In various embodiments, the bulk of the sensor transmitter assembly is formed as molded plastic components. In other embodiments, the sensor transmitter assembly is formed from ABS, nylon, an ABS/PC blend, PVC, polytetrafluoroethylene (PTFE), polypropylene, polyether ether ketone (PEEK), polycarbonate, or the like.

As illustrated inFIG. 2B,transmitter assembly106 includes abottom surface211 that is substantially flat and accommodates various components including at least one electronics module having a set of

contacts

217aand217b. In general, after insertion ofsensor portion104 into the body of a patient,transmitter assembly106 is connected tosensor assembly112 where

contacts

217aand217boftransmitter assembly106 are adapted to connect to corresponding contact pads on sensor assembly112 (e.g., at least one electronics component208) as will be described in more detail below, for example, with respect to the embodiment illustrated inFIGS. 15A-15C.Transmitter assembly106 includes a wireless transmitter that communicates with a remote device such as an infusion pump, a monitor device, or the like. In that regard,contacts217bare charging/communication contacts.Contacts217aare sensor contacts. In this embodiment, there are 4 charging/communication contacts217band 6sensor contacts217athat can include 1 reference electrode (RE), 1 counter electrode (CE) and 4 working electrodes (WE). Advantageously,

contacts

217aand217bare not insidetransmitter assembly106, but instead, they are substantially flush withbottom surface211 which provides easy access for cleaning and avoids potential corrosion.

In particular embodiments, a mounting base (or patch)102 is a large, stretchy patch that affixes thesensor assembly112 to the skin of the patient. Mounting base orpatch102 has abottom surface102a(as shown inFIG. 2B) that is adapted to be attached to the skin of the patient using appropriate attachment techniques, for example, an adhesive (e.g., a fluid adhesive, a spray adhesive, etc.), staples, or the like. In one or more embodiments, mounting base orpatch102 is made of a flexible and breathable material with adhesive properties, such as cloth, a bandage-like material, and the like. For example, suitable materials include polyurethane, polyethylene, polyester, polypropylene, polytetrafluoroethylene (PTFE), or other polymers. In other embodiments, mounting base orpatch102 is made of solid materials, for example, plastic, etc. Atop surface102bof mounting base102 (as shown inFIG. 2A) is adapted to be bonded or otherwise attached to an entire bottom surface ofsensor assembly112. As such, in various embodiments, mounting base orpatch102 is bonded to the entire device outline, not just to certain edges of the device, thus providing on-body stability. In various embodiments, glue, ultrasonic welding, etc. can be used for bonding. By applying pressure to the device, the pressure load spreads on the entire surface ofpatch102 creating a secure, stable adhesion to the body without the need for fold-over tape, overtape, or other inconvenient attachment techniques. In this way, items such as clothing may not be caught underneath the surfaces of mounting base orpatch102. Additional adhesive layers, liners, etc. can also be provided on the bottom of the mountingbase102 to temporarily secure the mountingbase102 as necessary.

Advantageously, the design and arrangement techniques of the sensor transmitter assembly according to one or more embodiments herein allow for a reduction in size compared to conventional assemblies as shown in the examples of Table 1 below.

TABLE 1

	Sensor Transmitter
	Assembly According
Conventional	to One or More
Sensor Assembly	Embodiments	% Reduction

Height (in)	0.37	0.31	16%
Width (in)	1.40	1.10	22%
Length (in)	1.56	1.10	30%
Footprint (in²)	1.51	0.95	37%
Volume (in³)	0.39	0.26	33%

Sensor/Transmitter Connection, Mechanical

In this embodiment, interface components, e.g., snap arms and tabs, can be flexible and less robust, and have been placed onsensor base219 at least in part becausesensor assembly112 is disposable. Interface components that are more robust, e.g.,slots218 and latches233, have been placed ontransmitter assembly106 at least in part because it is durable or inflexible. However, it should be noted that, conversely, in various embodiments, snaparms222 andtabs224 are located ontransmitter assembly106 andslots218 and latches233 are located onsensor assembly112. That is, one or more interface components, e.g., snap arms, tabs, slots and latches are interchangeable between the sensor assembly and the transmitter assembly.

Referring toFIGS. 3A-3C, side perspective views for mechanically connecting a sensor assembly to a transmitter assembly are illustrated according to an embodiment of the present disclosure. Initially, as illustrated in the embodiment ofFIG. 3A, atransmitter assembly106 is positioned, for example, lowered onto asensor assembly112 as indicated by downward arrow “A”. In that regard, an interface such as anopening216 oftransmitter assembly106 is lined up with, fits, or otherwise matches an interface such as acap209 ofsensor assembly112. In this embodiment, opening216 may be a hole having a round shape. In other embodiments opening216 may have different sizes or shapes such as a square, a hexagon, etc., that fits or otherwise engages with a corresponding interface (e.g., cap209) ofsensor assembly112. As described above according to one or more embodiments, one or more slots oftransmitter assembly106 engage into one or morecorresponding tabs224 ofsensor assembly112 to lock the transmitter and the sensor together axially (see, e.g.,FIGS. 2A-2B). In this embodiment, there are three tabs and three corresponding slots that provide a keyed structure such that the transmitter assembly drops in and lines up in a particular way (not randomly), locks, and does not move around.

As illustrated inFIG. 3B, oncetransmitter assembly106 is locked together axially withsensor transmitter112, a push or twist action (e.g., a clockwise rotating motion), as indicated by arrow “B”, is used to connecttransmitter assembly106 tosensor assembly112 together rotationally. Conversely, a counterclockwise rotation motion is used to disconnecttransmitter assembly106 fromsensor assembly112. It should be noted that in other embodiments, a clockwise rotating motion disconnects the transmitter assembly to the sensor assembly, and a counterclockwise rotation motion connects the transmitter assembly to the sensor assembly.Snap arms222 and latches233 (see, e.g.,FIGS. 2A-2B) lock the transmitter and the sensor assemblies together rotationally. As such, according to embodiments herein,transmitter assembly106 rests completely on top ofsensor assembly112. The sensor and transmitter assemblies are mechanically connected at the outermost edges, for example at three edges126 (also illustrated inFIG. 1A) wheretabs224 andslots218 lock the transmitter and the sensor assemblies together axially, and snaparms222 and latches233 lock the transmitter and the sensor assemblies together rotationally. This results in little relative movement being possible between the sensor and transmitter assemblies. Stable electrical connections are also ensured.

Advantageously, a twisting action is generally intuitive to a patient and allows the patient to connect (or disconnect) thetransmitter assembly106 to/from thesensor assembly112 with one hand without the patient having to look, thus allowing the patient to place and wear the sensor transmitter assembly on more locations on the body, even on locations where the patient has no visibility such as on the patient's back.FIG. 3C illustrates the sensor transmitter assembly as would be worn by the patient on-body as one unit. In this regard, mountingbase102 can be bonded to the patient's body andsensor portion104 can be positioned subcutaneously/transcutaneously in direct contact with a patient's extracellular fluid.

Sensor Assembly

Referring toFIG. 4, an exploded view of a sensor assembly is illustrated according to an embodiment of the present disclosure. Asensor assembly112 has components including without limitation a mountingbase102, asensor base219 having asensor head cavity415 and acap cavity418, asensor pad fastener407, asensor404, anelastomeric connector402, at least one innersquare ring406, an O-ring405, acap409 and an outersquare ring403. Mountingbase102 is adapted to be bonded to at least a portion of a bottom surface area ofsensor base219. In various embodiments, mountingbase102 is bonded to cover an entire bottom surface area or an entire outline ofsensor base219.Sensor base219 includessensor head cavity415 adapted to fittingly receive sensor pad fastener407 (e.g., an adhesive or the like). As such,sensor base219 andsensor pad fastener407 provide support to asensor404 and anelastomeric connector402 as will be described in more detail below, for example, with respect to the embodiments ofFIGS. 5A-5C.Cap cavity418 is adapted to fit at least onesquare ring406 that also provides a fluid seal forsensor404. O-ring405 fits around acap409 that is adapted to connect withcap cavity418. An outersquare ring403 fits around an outline ofsensor base219 and provides water tightness for the sensor assembly.

FIG. 59 is an alternative embodiment of an exploded view of a sensor assembly that includes a sensor base having one or more interfaces, e.g., two slots, adapted to engage with one or more corresponding interfaces, e.g., two rails, of a transmitter assembly as will be described in more detail below according to one or more embodiments.

Referring toFIGS. 5A-5C, top views for affixing a sensor head and an elastomeric connector to a sensor base of a sensor assembly are illustrated according to an embodiment of the present disclosure. InFIG. 5A,sensor base219 has a sensor head cavity (illustrated inFIG. 4) formed thereon that holds in place asensor head504 on a sensor pad fastener by using suitable fastening techniques such as double sided tape, adhesive, molded glue, a snap fit, or the like.

InFIG. 5B, anelastomeric connector402 is placed on top ofsensor head504. In various embodiments,elastomeric connector402 is retained by arib structure506 or by any other suitable structure such as a spring, a snap fit, etc.Rib structure506 provides dead volume forelastomeric connector402 to expand into in response to a transmitter assembly being connected to the sensor assembly as will be described in more detail below.

FIG. 5C is a side perspective view of the elastomeric connector fitted into the sensor head cavity ofsensor base219. In this embodiment, a top cross section ofelastomeric connector402 is square, which avoids having to orient the elastomeric connector in any particular direction. In an embodiment, it has approximately a 13% nominal compression.

In various embodiments,elastomeric connector402 is an elastomeric z-axis connector, for example, a ZEBRA connector (manufactured by FUJIPOLY) or other equivalent connector that includes alternating conductive and insulating regions in a rubber or elastomer matrix that produce overall anisotropic conductive properties. In general, ZEBRA connectors provide high-density redundant electrical paths for high reliability connections. ZEBRA connectors are generally flexible and create a gasket-like seal for harsh environments. The length, width and height may be specified as well as the stripe pitch to fit an application. In various embodiments, a recess with ribs is specified that captures and provides an elastomer reference surface for alignment (while allowing a lateral dimension of the elastomer to increase as it is compressed) with a deflection stop to control the final part separation, and alignment pins for substrate alignment. In some aspects, a “matrix” elastomeric connector includes short, fine, metallic wires, for example 300-2000 wires per square centimeter, aligned in parallel without touching each other, embedded in a rubber sheet. The wires either protrude slightly from the top and bottom of the rubber sheet, or they are curved and flush with the top and bottom planes. It should be noted that other type of Z-connectors may be used as well as leaf spring type connectors or the like. Elastomeric connectors used in various embodiments have alternating conductive and nonconductive layers supported by nonconductive supports, e.g., Silicone nonconductive supports. Inner conductive layers of an elastomeric connector create signal paths. Outer nonconductive layers prevent shorting between contacts.

Sensor Base/Sensor Portion/Needle/Cap Interface

FIG. 6 illustrates a partial top perspective view of a sensor assembly according to an embodiment of the present disclosure. As described above according to an embodiment, asensor base219 includes asensor head cavity415 adapted to receive a sensor pad fastener, a sensor and anelastomeric connector402. Atop portion615 ofsensor portion104 extends into an opening ofcap cavity418. Two identical innersquare rings406 sandwich a portion of substrate of the sensor, e.g.,top portion615 ofsensor portion104 as will be described in more detail below according to one or more embodiments.

FIGS. 7A-7E illustrate views of an interface for a sensor assembly including a sensor base, a sensor portion, a needle, and a cap according to an embodiment of the present disclosure. InFIG. 7A, a top part ofsensor portion104 is disposed in anopening706 extending along asensor base219. Identical inner square rings406 sandwich a portion of the sensor substrate, i.e., at least aportion715 of a top ofsensor portion104.Top sensor portion715 is angled at an angle “A°” (see alsoFIG. 7B). In alternative embodiments, angle “A°” has different angle values other than 90 degrees, for example 33°, 45°, or any other suitable angle. As such, this part of the sensor portion does not have a straight or sharp bend. Innersquare rings406 have a substantially square cross section when they are not compressed, which avoids slipping over each other. In an embodiment, they have a 5% OD compression.

As illustrated inFIG. 7B, upon compression for example by positioning acap409 on top of sensor base219 (i.e., into cap cavity418) with for example a 20% axial compression, inner square rings406 may expand so that a sensor fold is on a fluid side of a seal thus, there is no polyimide-against-polyimide gap to seal against. No glue, curing or other fastening techniques are needed. That is, in this embodiment, the two inner square rings406 sandwich an area of the sensor, e.g.,top sensor portion715, that is not folded back onto itself. This results in the inner square rings406 compressing against only one layer of the sensor. If the inner square rings were to compress against a folded region of the sensor, they would not seal a leak path created by a gap between two layers of the sensor. In this embodiment, everything is compressed together and supported. As illustrated inFIG. 7C, an insertion device such as aneedle710 is positioned though opening706 ofsensor base219. Notably, opening706 extends fittingly into a hole or opening711 ofcap409 of the sensor assembly to accommodateneedle710.

Referring toFIG. 7D, a partial side perspective view of a sensor assembly showing an interface of a sensor portion, a sensor base, a needle and a cap is illustrated according to an embodiment of the present disclosure.FIG. 7D illustrates an interface of asensor portion104, asensor base219, aneedle710 and acap409.Cap409 includes a hole or opening711 adapted to accommodateneedle710 throughcap409. In this embodiment, opening711 is substantially centered oncap409. The needle hole oropening711 is relieved for example with approximately a 3.5:1 aspect ratio for tool strength and to prevent over constraint betweencap409 andsensor base219. Needle hole or opening711 can be designed to fit needles of any profile.FIG. 7E is a detail of the interface illustrated inFIG. 7D according to an embodiment of the present disclosure.FIG. 7E illustrates the interface at a point “B”. Asensor clamp714 is located in an interior ofneedle710 to resist sensor pullups.Sensor clamp714 clamps down onsensor portion104.Needle710 does not touchsensor portion104. In various embodiments, after insertion into a patient's body, whenneedle710 is pulled out ofsensor base219, it pullssensor portion104 upwards at areas indicated by arrows “c” and “d”.Sensor clamp714 holdssensor portion104 down at an area indicated by arrow “e”. This puts the length of the sensor portion that is between upward pulling arrows “c” and “d” and downward pulling arrow “e” in tension. Because the sensor portion is in tension,needle710 slipspast sensor portion104, allowingsensor portion104 to stay in place asneedle710 retracts. Withoutclamp714,sensor portion104 would be carried alongneedle710 whenneedle710 is retracted, pullingsensor potion104 out of the patient's body.

FIG. 8 illustrates a sensor transmitter assembly with seals that improve water tightness according to an embodiment of the present disclosure. Acap809 of a sensor assembly has at least onecavity826 formed at each lateral side as further illustrated in detail “A”. Aradial seal823 is placed in arespective cavity826. In one or more embodiments,radial seals823 are self-lubricated. In some embodiments,radial seals823 are made of elastomeric materials. In a particular embodiment,radial seals823 are made of Nitrile or buna-n rubber. In various embodiments,radial seals823 have a round shape, but may have any appropriate shape. In various embodiments, a side portion ofsensor base819 further includes at least onecutout825 cut for example in an “L” shape or at a 90 degree angle, or at any other appropriate shape or angle adapted to receive aportion827 of atransmitter assembly806. Acrush seal822 is placed in arespective cutout825 formed at a connection betweenportion827 oftransmitter assembly806 andsensor base819 as further illustrated in detail “B”. Crush seals822 are held in place with friction. In various embodiments, crush seals822 have a square cross section to prevent any rolling or other type of movement. In various embodiments, crush seals822 are self-lubricated. In some embodiments, crush seals822 are made of elastomeric materials. In a particular embodiment, crush seals822 are made of Nitrile or buna-n rubber. In this way, potential leak paths (as represented by arrows a and c) are sealed byradial seals823 and potential leaks (as represented by arrows d and f) are sealed by crush seals822. Potential leaks (as represented by arrows b and e) are sealed by inner square rings406 described in the embodiments ofFIGS. 7A-7C. As such, water (or other liquid) tightness of the sensor transmitter assembly is ensured.

Transmitter Assembly

Referring toFIG. 9, an exploded view of a transmitter assembly is illustrated according to an embodiment of the present disclosure.

Atransmitter assembly906 includes without limitation atransmitter shell907 adapted to be connected or otherwise be positioned on atransmitter cap908.Transmitter shell907 andtransmitter cap908 each include

respective openings

916aand916badapted to be engaged with a sensor assembly cap as described above according to one or more embodiments.Transmitter shell907 includes ashell subassembly912 including acustom portion914 that houses, for example, a custom battery. Also,transmitter shell907 includes asubstrate portion918 on which a PCB board having various electronic components is disposed.Transmitter cap908 includes acap subassembly922 having recesses or

openings

924aand924bthat are adapted to respectively accommodate various components including fastening devices or materials, e.g., epoxy926aand926b,contacts928a(e.g., 4 contacts) and928b(e.g., 6 contacts), and

elastomeric connectors

932aand932b. Notably, no spring or other support components are necessary.

Referring toFIGS. 10A and 10B, side perspective views of a transmitter shell subassembly are illustrated according to an embodiment of the present disclosure.FIG. 10A illustrates a bottom side perspective view of a transmitter shell subassembly according to an embodiment. Atransmitter shell subassembly1012 includes, without limitation, components including acustom battery1014, for example a custom D-shaped battery (e.g., 36 mAh) adjoining aPCB1018 disposed therein. In various embodiments,PCB1018 is disposed on approximately one half portion ofshell subassembly1012 andcustom battery1014 is disposed on approximately the other half portion of the subassembly. Advantageously, the components are compressed or otherwise fit together such that no solder or other connections are necessary for the subassembly. In this way, the arrangement minimizes dead volume and reduces the height of the subassembly.FIG. 10B illustrates a top side perspective view of thetransmitter shell subassembly1012. In one or more embodiments,custom battery1014 is custom made to fit together withPCB1018. In various embodiments,PCB1018 includes achip antenna1032. Advantageously,chip antenna1032 is moved away fromcustom battery1014 for a more efficient layout. It should be noted that in various embodiments the subassembly fits various components as necessary, which are designed in various shapes or sizes to fit in the subassembly. For example, in alternative embodiments, there are one or more custom batteries (e.g., 1, 2, etc.) that are of particular shapes to fit together with a PCB of a particular shape and occupy less than half or more than half (e.g., one quarter, three quarters, etc.) of the subassembly. In various embodiments,custom battery1014 is a Lithium battery or it can be of any other appropriate chemistry. Also, in various embodiments, options for connecting the custom battery to the PCB include double sided tape, or adhesive to keep them in place or from shifting around.

Referring toFIG. 11A, a partial plane view of a transmitter assembly layout is illustrated according to an embodiment of the present disclosure. As described above, a shell subassembly of atransmitter assembly1106 includes aPCB1118 disposed on substantially one half portion and acustom battery1114 disposed on substantially the other half portion of the shell subassembly oftransmitter assembly1106.FIG. 11B illustrates another partial plane view of a transmitter assembly according to an embodiment of the present disclosure.

Elastomeric connectors

1132aand1132bare connected to aPCB1118.Elastomeric connector1132ais adapted to accommodate fourcontacts1128aandelastomeric connector1132bis adapted to accommodate sixcontacts1128b. No spring connectors are necessary.

Contacts

1128aand1128bare solid contacts that form a solid connection. It should be noted that in various embodiments the elastomeric connectors are adapted to accommodate different numbers of contacts as necessary for certain applications. For example,elastomeric connector1132aaccommodates any number of contacts such as 3, 5, 7, etc. andelastomeric connector1132baccommodates any number of contacts such as 4, 8, 10, etc.

FIG. 11C is a partial perspective view of a transmitter assembly layout illustrating details of external contacts to a PCB according to an embodiment of the present disclosure. As described above according to an embodiment,transmitter assembly1106 includes aPCB1118 disposed on substantially one half portion and acustom battery1114 disposed on substantially the other half portion oftransmitter assembly1106. As illustrated in detail “A”, a first side of anelastomeric connector1132 is attached to or otherwise connects with aPCB contact pad1135.External contacts1128 are disposed on or otherwise connected to another side ofelastomeric connector1132, which includes conductive material. Such connection layout eliminates the need for more intrusive connection methods (e.g., soldering) of external contacts to the PCB.

In various embodiments as described above,elastomeric connector1132 is a z-type connector, e.g. a ZEBRA connector that includes alternating conductive and insulating regions in a rubber or elastomer matrix that produce overall anisotropic conductive properties. It should be noted that other type of Z-connectors can be used as well as leaf spring type connectors.

Referring toFIGS. 12A-D, perspective views of transmitter cap contacts overmolding are illustrated according to an embodiment of the present disclosure.

InFIG. 12A, amold1221 of a transmitter cap for a transmitter assembly includes molded

portions

1203aand1203beach including at least one opening or hole formed thereon. In this embodiment, moldedportion1203ahas four holes and moldedportion1203bhas six holes. As illustrated in detail “A”, moldedportion1203aofmold1221 of the transmitter cap includes at least onehole1205a. As illustrated inFIG. 12B, holes formed on molded

portions

1203aand1203bare adapted to accommodatecontacts1204, which are positioned in corresponding holes. In various embodiments,contacts1204 are symmetric to avoid orientation issues inside a corresponding hole of molded

portions

1203aand1203b. As illustrated in detail “B”, fourcontacts1204 are positioned in corresponding holes formed on moldedportion1203a. InFIGS. 12C-12D, anovermolding1209 is placed on top of mold1221 (and contacts1204).Contacts1204 are insert molded intotransmitter cap1208. In various embodiments,mold1221 represents one half of a mold for a transmitter assembly, andovermolding1209 represents another half of the mold. First,contacts1204 are captured between the two mold halves, that is, betweenmold1221 andovermolding1209. Then,transmitter cap1208, for example, made of a plastic material, fills amold cavity1212 and encapsulates thecontacts1204.

Sensor/Transmitter Connection, Electrical

FIG. 13 illustrates side perspective views for electrically connecting a sensor assembly to a transmitter assembly according to an embodiment.

Asensor transmitter assembly1306 is connected to asensor assembly1312 by initially lowering downtransmitter assembly1306 intosensor assembly1312. As illustrated in detail “B”, at this stage, anelastomeric connector1332 and acontact1328 oftransmitter assembly1306 are not aligned with anelastomeric connector1302 ofsensor assembly1312. A twisting or rotation motion, as indicated by arrow “A”, is used to locktransmitter assembly1306 andsensor assembly1312. As a result of the rotation motion, as illustrated in detail “C”,elastomeric connector1332 andcontact1328 oftransmitter assembly1306 line up withelastomeric connector1302 ofsensor assembly1312, thus competing the connection.

Referring toFIG. 14, a partial top view of an electrical connection of a sensor assembly and at least one contact of a transmitter assembly is illustrated according to an embodiment of the present disclosure. As described above according to an embodiment, asensor assembly1412 has a cavity in which anelastomeric connector1432 is disposed. When a transmitter assembly is connected to the sensor assembly, at least one contact of the transmitter assembly makes a connection with theelastomeric connection1432. In this embodiment, sixcontacts1428 of a transmitter assembly connect withelastomeric connector1432. In some cases angular misalignment may occur between the contacts. In this embodiment, an angular misalignment of approximately 5° is shown between the contacts. Even thoughcontacts1428 do not line straight up, they still make electrical contact withelastomeric connector1432. As such, in various embodiments, a tolerance of up to about 5° angular misalignment can occur without disrupting the connection between the contacts and the elastomeric connector and otherwise running into another area. Advantageously, the angular misalignment is within a margin of error such that even if the contacts are angularly misaligned, the design of the elastomeric connector ensures that an electrical connection is robust. If a transmitter assembly is mechanically connected tosensor assembly1412, then an electrical connection is ensured.

Back to Back Sensor Connections

Referring now toFIGS. 15A-15C, back-to-back sensor connections are illustrated according to an embodiment of the present disclosure.FIG. 15A is a partial top side perspective view of a back-to-back sensor connection according to an embodiment of the present disclosure.FIG. 15B is a partial bottom side perspective view of a back-to-back sensor connection according to an embodiment of the present disclosure.FIG. 15C is a partial top view of a bottom surface of a transmitter assembly according to an embodiment.

As illustrated inFIGS. 15A and 15C, and as described above according to one or more embodiments (see, e.g.,FIG. 2B), atransmitter assembly1506 includes at least onetransmitter contact1517 disposed on abottom surface1511. In this embodiment, sixtransmitter contacts1517 are illustrated. An upper sensor includes asensor head1543 having at least one uppersensor contact pad1535. In this embodiment, six uppersensor contact pads1535 are illustrated. The upper sensor extends into or is otherwise connected toupper sensor electrodes1537. As illustrated inFIG. 15B, a lower sensor includes asensor head1545 having at least one lowersensor contact pad1539. In this embodiment, six lowersensor contact pads1539 are illustrated.Lower sensor head1545 extends into or is otherwise connected to lowersensor electrodes1541.

In particular embodiments, to create a double-sided sensor, two discrete single-sided sensors are placed back-to-back. For example, an upper sensor havingsensor head1543 is placed back-to-back with a lower sensor havinglower sensor head1545. As will be described in more detail below, for example, with respect to the embodiment ofFIG. 16, each single-sided sensor has 1 Reference Electrode (RE), 1 Counter Electrode (CE), and 2 independent Working Electrodes (WE) that correspond to sixcontacts1517 disposed on atransmitter cap1511 of atransmitter assembly1506 as illustrated inFIG. 15C. The REs of the two sensors are shorted together and connected to a shared RE transmitter contact. The CEs of the two sensors are shorted together and connected to a shared CE transmitter contact. Each WE on each of the two sensors is connected to its own independent WE transmitter contact (WE-A through WE-D).

Referring toFIG. 16, a top view of a sensor having at least one contact pad is illustrated according to an embodiment of the present disclosure. A single-sided sensor1640 has 1 CE, 1 RE and at least one WE, for example, WE-1 and WE-2. As shown, the CE has one contact pad, the RE has one contact pad, and each of the WEs has two contact pads connected in parallel, for example. Each WE contact pad has onetrace1643 leading to its corresponding electrode. The CE and RE pads each have twotraces1647 leading to their respective electrodes.

Referring now toFIG. 17, a top view of a sensor having windows cut through each of the sensor contact pads is illustrated according to an embodiment of the present disclosure. Asensor1740 is fabricated so that during fabrication, windows may be cut out through each of the sensor contact pads. In this embodiment, windows1707a-1707fare cut out through each corresponding sensor contact pad as illustrated. In various embodiments, windows1707a-1707fare cut out using, for example, laser cutting or any other suitable cutting techniques. Traces from the contact pads leading to their respective electrodes run to one side, for example, the left side. In this embodiment, because the traces from the WE-1 and WE-2 contact pads run to the left side, cutting out windows on the left side of the contact pad deactivates that contact pad. Cutting out windows on the right side keeps the contact pad active. In this embodiment, as a result ofwindow1707bof WE-1 andwindow1707dof WE-2 being cut out (on the right side),contact pad1703aof WE-1 andcontact pad1703bWE-2 remain active. Conversely, cutting

windows

1707aand1707con the left side of the respective WE contact pads, deactivates those contact pads. That is, cutting out a window on a side of a WE contact pad where the traces run, deactivates the contact pad.

Notably, on each single-sided sensor, for example,sensor1740, the windows cut through respective WE contact pads are staggered so that only one of the two contact pads for each WE remains active. For example, in this embodiment, each of WE-1s contact pads has awindow1707acut on the left side and awindow1707bcut on the right side, so that only WE-1contact pad1703ahaving a window cut on the right side remains active. Similarly, WE-2s contact pads has awindow1707ccut on the left side and awindow1707dcut on the right side, so that only WE-2contact pad1703bhaving its window cut on the right side remains active. With respect to the RE contact pad and the CE contact pad, because the CE and RE contact pads each have two traces, one on each side of the corresponding contact pad, the CE and RE contact pads remain active regardless of which side the window is on.

FIG. 18 illustrates a back-to-back sensor combination according to an embodiment of the present disclosure. A first sensor1840aand a second sensor1840bare combinable to form a back-to-back sensor. In this embodiment, first sensor1840aand second sensor1840beach has 6 contact pads including 4 WE pads (2 WE1 pads and 2 WE2 pads each). Each of the 6 contact pads of first sensor1840ahaswindows1807a-1807fcreated or cut out through a contact pad head of first sensor1840a, and each of the 6 contact pads of second sensor1840bhaswindows1807g-1807L created or cut out through a contact pad head of second sensor1840b. In various embodiments,windows1807a-1807L are cut by using an appropriate cutting technique such as are laser cutting.Windows1807a-1807fof first sensor1840aare mirror images ofwindows1807g-1807L of second sensor1840b. By mirroring a cut pattern forwindows1807a-1807L, active WE pads are staggered between the two sensors1840aand1840b. In that regard, awindow1807acut on a left side of WE1 contact pad in first sensor1840aresults in an inactive pad, and awindow1807gcut on a right side ofWE 1 contact pad in second sensor1840bresults in an active pad. Awindow1807bcut out on a right side of WE1 contact pad in first sensor1840aresults in an active pad, and awindow1807hcut on a left side of WE1 contact pad in second sensor1840bresults in an inactive pad. Awindow1807ccut out on a left side of WE1 contact pad in first sensor1840aresults in an inactive pad, and a window1807icut on a right side of WE1 contact pad in second sensor1840bresults in an active pad. Awindow1807dcut out on a right side of WE1 contact pad in first sensor1840aresults in an active pad, and a window1807jcut on a left side of WE1 contact pad in second sensor1840bresults in an inactive pad. It should be understood that the cut-out parts on the contact pads can be done on alternative sides (left or right) to mirror each other as appropriate.

In addition, first sensor1840aand second sensor1840beach have a CE contact pad and an RE contact pad. Each respective CE contact pad and RE contact pad of first sensor1840aand second sensor1840bhave twotraces1847. In that regard, CE contact pad of first sensor1840ahas a cut outwindow1807ehaving one trace, and another trace is on the non-cut out part of the contact pad. Similarly, CE contact pad of second sensor1840bhas a cut outwindow1807khaving one trace, and another trace is on the non-cut out part of the contact pad. RE contact pad of first sensor1840aalso has a cut out window1807fon one trace, and another trace is on the non-cut out part of the contact pad. Similarly, RE contact pad of second sensor1840bhas a cut out window1807L on one trace, and another trace is on the non-cut out part of the contact pad. Because the CE and RE contact pads each have two traces, one on each side of the corresponding contact pad, the CE and RE contact pads remain active regardless of which side the window is on.

FIGS. 19A-19C illustrate views for placing a first sensor and a second sensor back to back and creating a signal path according to an embodiment of the present disclosure. As illustrated inFIG. 19A, afirst sensor1940aand asecond sensor1940bhave mirrored window cut patterns across each respective sensor pad head as described above, for example with respect to the embodiment ofFIG. 18. As illustrated inFIG. 19B,first sensor1940ais placed back to back withsecond sensor1940b, for example, by placing or turningsecond sensor1940bas indicated by arrow “A” intofirst sensor1940a. Becausefirst sensor1940aandsecond sensor1940bhave mirrored window cut patterns, the windows of each respective sensor are aligned as illustrated inFIG. 19C. As a result, a signal path is provided between the contact pads offirst sensor1940aand a transmitter as will be described in more detail below.

FIG. 20 illustrates a back-to-back sensor connection to a transmitter assembly according to an embodiment of the present disclosure. Atransmitter assembly2006 includes at least onecontact2017, for example 6 contacts: one RE, one CE, and 4 WEs (WE-D, WE-C, WE-B and WE-A). Afirst sensor head2040aincludes 6 contact pads having cut out windows, for example as described above with respect to the embodiments ofFIGS. 17-18. In this embodiment contact pads corresponding to WE-D and WE-B are active, and contact pads corresponding to WE-C and WE-A are inactive. Asensor assembly2012 includes asecond sensor2040b.Second sensor2040bhas 6 contact pads having cut out windows as described above for example with respect to the embodiments ofFIGS. 17-18. In this embodiment, contact pads corresponding to WE-C and WE-A are active, and contact pads corresponding to WE-D and WE-B are inactive.

Whenfirst sensor2040ais combined withsecond sensor2040b(for example as described above according to the embodiments ofFIGS. 19A-19C), a signal path totransmitter contacts2017 is created through active contact pads WE-D and WE-B offirst sensor2040aand through active contact pads WE-C and WE-A ofsecond sensor2040b. In this embodiment,first sensor2040ais an upper sensor andsecond sensor2040bis a lower sensor. In alternative embodiments, because the pattern of active/inactive pads are interchangeable, the upper sensor has a pattern similar tosecond sensor2040bof this embodiment, and the lower sensor has a pattern similar tofirst sensor2040aof this embodiment.

FIG. 21 illustrates a back-to-back sensor disposed in between elastomeric connectors according to an embodiment of the present disclosure. A back-to-back sensor2140 as described above for example with respect to the embodiments ofFIGS. 19A-19C is placed on a lowerelastomeric connector2132a. Then, an upperelastomeric connector2132bis positioned on top of back-to-back sensor2140 to form a sensor/connector stack2142. As such,sensor connector stack2142 includes the back-to-back sensor2140 sandwiched or otherwise placed in between two elastomeric connectors.

Electrodes

2104aand2104bextend from or are otherwise connected to respective sensor heads (e.g., lower sensor head and upper sensor head) of back-to-back sensor2140. In various embodiments, lowerelastomeric connector2132aand/or upperelastomeric connector2132bare z-axis elastomeric connectors. For example, they are ZEBRA connectors. The upper and lower

elastomeric connectors

2132aand2132bhave alternating conductive andnonconductive layers2139 supported bynonconductive supports2137, e.g., Silicone nonconductive supports. In various embodiments, an inner conductive layer of an elastomeric connector creates signal paths. Outer nonconductive layers prevent shorting between contacts.

FIG. 22 is a partial side perspective view of a sensor transmitter assembly having a back-to-back sensor connected to a transmitter according to an embodiment of the present disclosure. Atransmitter assembly2206 is connected to asensor assembly2212. Aconnector stack2242 includes a back-to-back sensor sandwiched or otherwise placed in between two elastomeric connectors as described above for example with respect to the embodiment ofFIG. 21. Whentransmitter assembly2206 is connected tosensor assembly2212, sensor-connector stack2242 is compressed between transmitter contacts (not shown) and a sensor base ofsensor assembly2212. Asensor portion2104 extends from or is otherwise connected toconnector stack2242.

Referring toFIG. 23, a perspective view of a connection between sensor contact pads and transmitter contacts is illustrated according to an embodiment of the present disclosure. Atransmitter assembly2306 includes at least onecontact2317. In this embodiment,transmitter assembly2306 includes 6contacts2317. Asensor connector stack2342 includes six contact pads of back-to-back sensors that connect totransmitter contacts2317 through conductive layers of an upperelastomeric connector2332.

FIG. 24 is a bottom perspective view of a connection of a sensor contact pad to a transmitter contact according to an embodiment of the present disclosure. In formingsensor transmitter assembly2400, a transmitter assembly is connected to a sensor assembly as described above according to one or more embodiments. As a result of the connection, an upper elastomeric connector and a lower elastomeric connector are compressed and extrude into sensor windows such aswindow2407 of a contact pad. The upper and lower elastomeric connectors also compress against each other, i.e., they may overlap. Lower sensor contact pads, for example a lowersensor contact pad2403, is connected to the transmitter contacts, forexample transmitter contact2417, as a result of an overlap of at least one conductive layer of an upper elastomeric connector with at least one conductive layer of a lower elastomeric connector.

FIG. 25 illustrates a detailed connection of at least one sensor contact pad to a transmitter contact according to an embodiment of the present disclosure. Atransmitter assembly2506 connects with asensor assembly2512 compressing lower and upper

elastomeric connectors

2532aand2532b.

Elastomeric connectors

2532aand2532bsandwich upper andlower sensors2540 as described above according to one or more embodiments. An inactive contact pad of the upper sensor that is located directly above an active contact pad on the lower sensor acts as a conductor. As a result, contact resistance is minimized between the lower sensor contact pad and a transmitter contact, for example,transmitter contact2517, in case there is overlap between only one pair of conductive layers of an upper elastomeric connector and a lower elastomeric connector. That is, even if only one pair of conductive layers of the upper and lower elastomeric connectors line up, that is all that is needed for making contact withtransmitter contact2517. This is facilitated by the spreading of or compression of the elastomeric connectors when connectingtransmitter assembly2506 tosensor assembly2512.

Referring toFIG. 26, a connection of a CE or RE to a transmitter is illustrated according to an embodiment of the present disclosure. Acontact pad2607aof an upper sensor, for example a contact pad of a CE or RE, and acontact pad2607bof a lower sensor, for example a corresponding CE or RE are both connected to theircommon transmitter contact2617. As indicated, both thecontact pad2607aand thecontact pad2607bare connected via an elastomeric connector.

Referring now toFIGS. 27A-27C, views of a first sensor and a second sensor having mirrored contact pads and respective connections to a transmitter are illustrated according to an embodiment of the present disclosure. As illustrated in the embodiment ofFIG. 27A, a first sensor and a second sensor having mirrored contact pad windows are illustrated according to an embodiment of the present disclosure. Afirst sensor2740a“A” and asecond sensor2740b“B” each has a windows pattern cut through each sensor head as described above according to one or more embodiments. The cut pattern of one sensor mirrors the cut pattern of the other sensor. That is, the cut patterns of first sensor “A” and second sensor “B” mirror each other. For example, a contact pad of the first sensor “A” having a window2707acut on the left side mirrors a contact pad of the second sensor “B” having awindow2707bcut on the right side. In this way, the contact pads of each sensor line up when they are connected to corresponding transmitter contacts. Advantageously, it is unnecessary in manufacturing to control which sensor is on top. The device functions regardless of which sensor is on top as a result of the contact pad windows lining up.

FIG. 27B illustrates an embodiment where a first sensor “A” is on top of a second sensor “B”. In this embodiment, a first sensor “A” may be positioned or otherwise connected between second sensor “B” andtransmitter contacts2717. Transmitter contacts include an RE, a CE and 4 WEs (WE-D, WE-C, WE-B and WE-A). Because the windows cut on each contact pad of first sensor “A” mirror contact pads of second sensor “B”, they line up and the sensor functions. For example, the contact pad of the first sensor “A” that corresponds to transmitter contact WE-D has a window cut on a side where itstrace2747 does not connect thus making the contact pad active. Even though the corresponding contact pad of second sensor “B” has a window cut on a side where its trace connects thus making the contact pad inactive, a connection with transmitter contact WE-D is established by the active contact pad of first sensor “A” lining up with the inactive pad of second sensor “B”. Similarly, the contact pads of first sensor “A” line up with the contact pads of second sensor “B” such that the mirrored cut windows line up to establish a connection with each transmitter contact WE-C, WE-B and WE-A. As described above, the CE and RE for both the first sensor “A” and the second sensor “B” have two traces each and are connected to their common transmitter contact.

FIG. 27C illustrates an embodiment where the second sensor “B” is on top of the first sensor “A”. In this embodiment, the second sensor “B” is positioned or otherwise connected between the first sensor “A” andtransmitter contacts2717. As described above, because the windows cut on each contact pad of second sensor “B” mirror contact pads of first sensor “A”, they line up and the sensor functions. For example, the contact pad of the second sensor “B” that corresponds to transmitter contact WE-D has a window cut on a side where itstrace2747 connects thus making the contact pad inactive. However, the corresponding contact pad on first sensor “A” has a mirrored window cut on a side where its trace does not connect thus making the contact pad active. As such, a connection with transmitter contact WE-D is established by the active contact pad of first sensor “A” lining up with the inactive contact pad of second sensor “B”. Similarly, the contact pads of second sensor “B” line up with the contact pads of first sensor “A” such that the mirrored cut windows line up to establish a connection with each transmitter contact WE-C, WE-B and WE-A. As described above, the CE and RE for both the first sensor “A” and the second sensor “B” have two traces each and are connected to their common transmitter contact.

Alternative embodiments for back to back sensor connections are described below with respect toFIGS. 69A-82.

Mechanical Lockouts

As described above according to one or more embodiments, a device or product includes a transmitter assembly positioned on top of a sensor assembly. In certain embodiments, it is likely that some generations of devices or products include a transmitter assembly and a sensor assembly that are functionally incompatible with each other. For example, a device includes a transmitter assembly using a new transmitter algorithm paired with an older sensor assembly. In particular examples, an assembly meant for pediatric use may be incompatible with an assembly meant for adult use, or an assembly meant for a heavy person's use may be incompatible with an assembly meant for a small person's use. In some embodiments, it is necessary to provide ways to prevent incompatible transmitter assemblies and sensor assemblies from connecting to each other both mechanically and electrically. One or more embodiments allow lockouts to prevent incompatible transmitter and sensor assemblies from connecting. The lockouts are changed easily and independently of other potentially critical features. In an embodiment, interfaces such as slots and rails on respective sensor or transmitter assemblies are used to block a transmitter from fully rotating onto and making a connection with a non-compatible sensor.

In some embodiments, mutually exclusive generations of sensor assemblies and transmitter assemblies are created by changing lockout features, e.g., a length, a width, a depth, a shape, a positioning, etc. of interfaces such as slots in a sensor base and the corresponding mating features, e.g., the mating rails in the transmitter assembly. Changing the features of the sensor base and the corresponding mating features in the transmitter assembly is accomplished by using interchangeable mold inserts, or by other appropriate techniques such as adding interfaces e.g., slots or rails to the respective assembly by carving, soldering, adhering, etc.

In particular embodiments, the lockout features are located on non-critical surfaces of, for example, a sensor base of a sensor assembly and/or a transmitter cap or shell of a transmitter assembly. For instance, these surfaces are not cosmetic and are not sealing surfaces. Because these surfaces are non-critical, it is functionally acceptable if they have visible mold parting lines. As such, in various embodiments, this allows different lockout configurations to be created by using, for example, interchangeable mold inserts rather than by creating entirely new molds for each configuration.

Referring now toFIG. 28, perspective side views of a sensor assembly and a transmitter assembly having mechanical lockouts are illustrated according to an embodiment of the present disclosure. To create lockout features, asensor assembly2812 includes asensor base2819 to which at least oneslot2805 is added. In this embodiment,sensor base2819 has twoslots2805. One slot defines the generation of the sensor assembly. The other slot determines which transmitter generations will fit with that sensor assembly. Similarly, atransmitter assembly2806 includes atransmitter cap2811 to which at least onerail2803 is added. In this embodiment, two rails are added totransmitter cap2811. One rail defines the generation of the transmitter. The other rail determines which sensor generations will fit with that transmitter.

Referring toFIGS. 29A-29B, top views of a sensor transmitter assembly with mechanical lockouts are illustrated according to an embodiment of the present disclosure. As described above according to one or more embodiments, atransmitter assembly2906 is initially engaged to a sensor assembly by lowering down the transmitter assembly onto the sensor assembly guided by acap2914 disposed on the sensor assembly. To complete a connection of the transmitter assembly to the sensor assembly, the transmitter assembly is rotated, for example, in a clockwise manner as indicated by arrow “A” inFIG. 29A. In this way, rails disposed on transmitter assembly2906 (for example as illustrated inFIG. 28), rotate throughslots2905 disposed on the sensor assembly (see for exampleFIG. 28). InFIG. 29B, the slots of the sensor assembly are long enough to allow therails2903 to rotate all the way through as shown at points “B” and “C”. As a result of the slots being long enough to allow full rotation of the rails, the transmitter assembly locks into the sensor assembly and makes contact, for example,contacts2917 of the transmitter assembly align with contact pads of asensor stack2942 of the sensor assembly as shown at point “D”. It should be noted that in various embodiments, the sensor assembly and the transmitter assembly will connect with each other even when the contacts are misaligned by a certain angle, for example a 5 degree misalignment (see for example the embodiment ofFIG. 14).

FIGS. 30A-30B are top views of a sensor transmitter assembly with mechanical lockouts according to another embodiment of the present disclosure. According to one or more embodiments, new generation transmitter assemblies are incompatible with older-generation sensor assemblies. For example, a new generation transmitter assembly includes a new transmitter algorithm that is incompatible with an older generation sensor assembly. In this case the new-generation transmitter assembly is made to lock out the older-generation sensor. As illustrated inFIG. 30A, to make a new generation transmitter lock out an older-generation sensor, arail3003adisposed e.g., on a right side of a transmitter cap of the transmitter assembly is extended, that is, the length of the rail is increased by a length “x”. In various embodiments, the length ofrail3003ais extended by an appropriate “x” amount such as 2 mm, 5 mm, 10 mm, etc. The transmitter assembly is engaged with the sensor assembly and the transmitter assembly is rotated, for example, in a clockwise direction as indicated by arrow “A” such that the

rails

3003aand3003bdisposed on the transmitter assembly rotate through the slots disposed on the sensor assembly. However, as illustrated inFIG. 30B, becauserail3003ahas been extended (e.g., its length has been increased by an “x” amount),rail3003areaches the end of its corresponding slot at point “D”. As such, becauserail3003ais extended, it prevents full rotation of the transmitter assembly. In this case,contacts3017 of the transmitter assembly do not line up or connect with contact pads of asensor stack3042 of the sensor assembly. The transmitter assembly locks out the sensor assembly. It should be noted that in various embodiments, because the sensor assembly and the transmitter assembly would connect even when misaligned, for example misaligned by about 5 degrees, the levels of lockouts would differ from each other by a much larger angle to prevent a connection. In this embodiment, each level of lockout is about 20 degrees. The angular misalignment in this case (e.g., 20 degrees) exceeds a particular maximum level of lockout that would allow a connection.

FIGS. 31A-31B are top views of a sensor transmitter assembly with mechanical lockouts according to yet another embodiment of the present disclosure. In the embodiments ofFIG. 31A-31B, a new generation sensor assembly is made to lock out an older-generation transmitter. As illustrated inFIG. 31A, aslot3105adisposed for example on a left side of a sensor base of a new generation sensor assembly is shortened, that is, the length of the slot is decreased by an amount “Z”. In various embodiments, the length ofslot3105ais shortened by an appropriate amount such as 2 mm, 5 mm, 10 mm, etc. The sensor assembly is engaged with a transmitter assembly, which is rotated, for example, in a clockwise direction as indicated by arrow “A” such that the

rails

3103aand3103bdisposed on the transmitter assembly rotate through the slots disposed on the sensor assembly. However, as illustrated inFIG. 31B, becauseslot3105ahas been shortened (i.e., its length has been decreased by a “Z” amount),rail3103areaches the end of its corresponding slot at point “B”. As a result, full rotation of the transmitter assembly is prevented. In this case,contacts3117 of the transmitter assembly do not line up or connect with contact pads of asensor stack3142 of the sensor assembly. The sensor assembly locks out the transmitter assembly. It should be noted that in various embodiments, because the sensor assembly and the transmitter assembly would connect even when misaligned, for example misaligned by about 5 degrees, the levels of lockouts would differ from each other by a much larger angle to prevent a connection. In this embodiment, each level of lockout is about 20 degrees. The angular misalignment in this case (e.g., 20 degrees) exceeds a particular maximum level of lockout that would allow a connection.

Referring toFIGS. 32A-32B, lockouts for different generations of transmitter assemblies and sensor assemblies are illustrated according to an embodiment of the present disclosure. InFIG. 32A, asensor assembly base3219 has aslot3205aand aslot3205b. As described above according to one or more embodiments,

slots

3205aand3205bare adapted to engage or otherwise receive a corresponding rail of a transmitter assembly. To determine which transmitter generation(s) are received or accepted by the sensor assembly, one or more features of

slots

3205aand3205bare adjusted. For example, the length ofslot3205adetermines which transmitter generation(s) the sensor assembly will accept. It should be noted that transmitter assembly generations are designated by

numeral references

1, 2, 3. For example, an old generation transmitter is designated by numeral reference “1”, a newer generation transmitter is designated by numeral reference “2”, and an even newer generation transmitter is designated by numeral reference “3”. In this embodiment,slot3205aof a length “a” determines that the sensor assembly will accept transmitter generation(s) 1, 2, 3. A shorter length “b” ofslot3205aresults in the sensor assembly accepting transmitter generation(s) 2 and 3. And a shorter length “c” ofslot3205aresults in the sensor assembly only receiving atransmitter generation 3. In alternative embodiments, it should be noted that mechanical lockouts have a variety of corresponding features including, for example, a different shape, width, depth, positioning, etc.).

With respect to slot3205b, its length determines the generation of the sensor assembly, for example,slot3205bfor an old generation sensor (designated by a numeral reference “la”) has a length “d”,slot3205bfor a newer generation sensor (designated by a numeral reference “2a”) has a length “e”, andslot3205bfor an even newer generation sensor (designated by a numeral reference “3a”) has a length “f”. That is, the length ofslot3205bis extended to length “e” for anewer generation sensor2aand the length ofslot3205bis extended to length “f” for an even newer generation sensor3a.

InFIG. 32B, atransmitter assembly base3206 has arail3203aand arail3203b. As described above according to one or more embodiments,

rails

3203aand3203bare adapted to engage or otherwise connect with a corresponding slot of a sensor assembly. To determine which sensor generation(s) engages with the transmitter assembly, one or more features of

rails

3203aand3203bare adjusted. For example, the length ofrail3203bdetermines which sensor generation(s) the transmitter assembly will accept. It should be noted that sensor assembly generations are designated by

numeral references

1, 2, 3. For example, an old generation sensor is designated by numeral reference “1”, a newer generation sensor is designated by numeral reference “2”, and an even newer generation sensor is designated by numeral reference “3”. In this embodiment,rail3203bis of a length “g”, which determines that the transmitter assembly will accept sensor generation(s) 1, 2, 3. A length “h” ofrail3203bdetermines that the transmitter assembly will accept sensor generation(s) 2 and 3. And a length “i” ofrail3203bdetermines that the transmitter assembly will only receive asensor generation 3.

With respect to rail3203a, its length determines the generation of the transmitter assembly, for example,rail3203afor an old generation transmitter has a length “1x”,rail3203afor a newer generation transmitter has a length “2y”, andrail3203afor an even newer generation transmitter has a length “3z”. That is, a newer generation transmitter assembly has aslot3203aof a shorter length “2y”, and an even newer generation transmitter assembly has aslot3203aof an even shorter length “3z”. It should be noted that in general, generations of transmitters and sensors are fabricated based on various factors including for example: as needed by an application, at a given time frequency (e.g., every year, every quarter, etc.), based on a release of a new product, in response to a design improvement, etc.

Referring now toFIGS. 33A-33B, lockouts for different generations of transmitter assemblies and sensor assemblies are illustrated according to another embodiment of the present disclosure. In various embodiments, each sensor assembly includes at least one mechanical lockout having features that determine the generation of the sensor assembly and what transmitters the sensor assembly will accept. Similarly, each transmitter assembly includes at least one mechanical lockout having features that determine the generation of the transmitter assembly and what sensors the transmitter assembly will accept. The features of the mechanical lockouts include, for example, a length, a shape, a width, a depth, a positioning, etc. In one or more embodiments, each sensor assembly includes two slots. One slot defines which generation that sensor is. The other slot determines which transmitter generations will fit with that sensor. Similarly, each transmitter assembly includes two rails. One rail defines which generation that transmitter is. The other rail determines which sensor generations will fit with that transmitter.

InFIG. 33A, asensor base3319 of a sensor assembly includes aslot3305bthat defines the generation the sensor assembly, and aslot3305athat defines which generations of transmitters that sensor assembly will accept. In this case,slot3305bdefines the generation of the sensor assembly as being aGeneration 1 sensor assembly.Slot3305adetermines that

Generations

1, 2, 3 transmitters will be accepted. Similarly, a transmitter cap oftransmitter assembly3306 includes arail3303athat defines the generation of the transmitter assembly, and arail3303bthat defines which generations of sensors that transmitter will accept. In this case,rail3303adefines the generation of the transmitter assembly as being aGeneration 1 transmitter.Rail3303bdetermines that

Generations

1, 2, 3 sensors will be accepted.

In the first pair “I” of corresponding slots and rails,slot3305a, which determines that

Generations

1, 2, 3 transmitters will be accepted, pairs withrail3303a, which defines aGeneration 1 transmitter. And in the second pair II,slot3305b, which determines aGeneration 1 sensor assembly, pairs withrail3303b, which determines that

Generations

1, 2, 3 sensors will be accepted.

As such, as illustrated inFIG. 33B, whentransmitter assembly3306 is connected tosensor base3319, a connection is completed because there is overlap in both pairs of corresponding slots and rails. In this regard, features such as the length of corresponding slots and rails do not prevent the sensor assembly and the transmitter assembly from connecting as indicated at points “A” and “B”.Contacts3317 oftransmitter assembly3306 line up (or are within a certain angular misalignment) with contact pads ofsensor stack3342 as indicated at point “C”.

Referring now toFIGS. 34A-34B, lockouts for different generations of a transmitter assembly and a sensor assembly are illustrated according to yet another embodiment of the present disclosure. InFIG. 34A, asensor base3419 of a sensor assembly includes aslot3405bthat defines the generation the sensor assembly, and aslot3405athat defines which generations of transmitters that sensor assembly will accept. In this case,slot3405bdefines the generation of the sensor assembly as being aGeneration 1 sensor assembly.Slot3305adetermines that

Generations

1, 2, 3 transmitters will be accepted. Similarly, a transmitter cap oftransmitter assembly3406 includes arail3403athat defines the generation of the transmitter assembly, and arail3403bthat defines which generations of sensors that transmitter will accept. In this case,rail3403adefines the generation of the transmitter assembly as being aGeneration 2 transmitter.Rail3403bdetermines that

Generations

2, 3 sensors will be accepted. In the first pair “I” of corresponding slots and rails,slot3405a, which determines that

Generations

1, 2, 3 transmitters will be accepted, pairs withrail3403a, which defines aGeneration 2 transmitter. However, in the second pair II,slot3405b, which determines aGeneration 1 sensor assembly, does not pair withrail3403b, which determines that

only Generations

2, 3 sensors will be accepted.

As such, as illustrated inFIG. 34B, whentransmitter assembly3406 is connected tosensor base3419, a connection is not completed because both pairs of corresponding slots and rails do not overlap. In this regard, features such as the length of corresponding slots and rails prevent the sensor assembly and the transmitter assembly from connecting, for example, whenrail3403breaches the end ofslot3405bat point “B”, the transmitter assembly is prevented from rotating all the way through.Contacts3417 oftransmitter assembly3406 do not line up (or are not within a certain angular misalignment) with contact pads ofsensor stack3442 as indicated at point “C”.

Referring now toFIG. 35, top views of different generations of sensor and transmitter assemblies with different mechanical lockouts are illustrated according to one or more embodiments of the present disclosure. Mechanical lockouts, for example slots and rails, are used to make sensor and transmitter generations mutually exclusive. For example, aGeneration 1 sensor will connect only with aGeneration 1 transmitter, and aGeneration 2 sensor will connect only with aGeneration 2 transmitter as illustrated in the embodiment ofFIG. 35. In that regard, in some embodiments, the relative features of the mechanical lockouts, for example, the relative lengths of the slots and rails are made to prevent the transmitter assembly from rotating enough so that a connection with the sensor assembly is not completed. In other embodiments, the relative lengths of the slots and rails are made to allow the transmitter assembly to rotate enough to connect with the sensor assembly.

Atransmitter assembly3506aincludes aGeneration 1 transmitter and has arail3503aand arail3503b.Rail3503ais made to correspond toGeneration 1 of the transmitter assembly.Rail3503bis made to correspond to

Generations

1, 2 and 3 of a sensor assembly. Atransmitter assembly3506bincludes aGeneration 2 transmitter and has arail3503cand arail3503d.Rail3503cis made to correspond only toGeneration 2 of the transmitter assembly.Rail3503dis made to correspond only to

Generations

2 and 3 of a sensor assembly. Asensor assembly3512aincludes aGeneration 1 sensor and has a slot3505aand aslot3505b. Slot3505ais made to correspond to

Generations

1, 2 and 3 of a transmitter assembly.Slot3505bis made to correspond only toGeneration 1 of the sensor assembly. A sensor assembly3512bincludes aGeneration 2 sensor and has aslot3505cand aslot3505d.Slot3505cis made to correspond to

Generations

2 and 3 of a transmitter assembly.Slot3505dis made to correspond only toGeneration 2 of the sensor assembly.

In case “I”,sensor assembly3512ahas a slot3505athat accepts

Generations

1, 2, 3 of transmitters and is paired with arail3503aoftransmitter assembly3506a, which has aGeneration 1 transmitter.Slot3505b, which defines aGeneration 1 sensor, is paired withrail3503bthat determines that

sensor Generations

1, 2, 3 will be accepted. As such, there is overlap in both pairs of corresponding slots and rails such that a connection of the sensor assembly and the transmitter assembly is completed. In this regard, the relative lengths of the slots and rails allow the transmitter to rotate enough as indicated by points “A” and “B” so thattransmitter contacts3517aalign with sensor contact pads ofsensor stack3542aas indicated at point “G”. AGeneration 1 sensor connects with aGeneration 1 transmitter.

However, in case “II”,sensor assembly3512aincluding aGeneration 1 sensor will not connect with atransmitter assembly3506bhaving aGeneration 2 transmitter.Rail3503druns into the end ofslot3505bat point “C” before thetransmitter contacts3517bline up with sensor contact pads ofsensor stack3542aas indicated at point “H”. In other words, the contact ofrail3503dinto the end ofslot3505bat point “C” blocks the transmitter assembly from rotating all the way into the connection position. AGeneration 1 sensor does not connect with aGeneration 2 transmitter.

In case “III”, sensor assembly3512bincluding aGeneration 2 sensor does not connect with atransmitter assembly3506ahaving aGeneration 1 transmitter. When sensor assembly3512bis connected totransmitter assembly3506a, there is no overlap in both pairs of corresponding slots and rails. No connection is made becauserail3503aruns into the end ofslot3505cat point “D” before thetransmitter assembly3506acan be rotated all the way, blocking the connection.Contacts3517aof the transmitter assembly do not connect with contact pads ofsensor stack3542bas indicated at point “J”. AGeneration 2 sensor does not connect with aGeneration 1 transmitter.

In case “IV”, sensor assembly3512bhas aslot3505cthat accepts

Generations

2, 3 of transmitters and is paired with arail3503coftransmitter assembly3506b, which has aGeneration 2 transmitter.Slot3505d, which defines aGeneration 2 sensor, is paired withrail3503dthat determines that

sensor Generations

2, 3 will be accepted. As such, there is overlap in both pairs of corresponding slots and rails such that a connection of the sensor assembly and the transmitter assembly is completed. In this regard, the relative lengths of the slots and rails allow the transmitter to rotate enough as indicated by points “E” and “F” so thattransmitter contacts3517balign with sensor contact pads ofsensor stack3542bas indicated at point “K”. AGeneration 2 sensor connects with aGeneration 2 transmitter.

Referring now toFIG. 36, top views of different generations of sensor and transmitter assemblies with different mechanical lockouts are illustrated according to another embodiment of the present disclosure. Mechanical lockouts, for example interfaces such as slots and rails, are used to make sensor or transmitter generations backwards compatible. For example, aGeneration 2 sensor will only connect with aGeneration 2 transmitter. However, theGeneration 2 transmitter is backwards compatible and will connect with both aGeneration 1 and aGeneration 2 sensor as illustrated in the embodiment ofFIG. 36.

Atransmitter assembly3606aincludes aGeneration 1 transmitter and has arail3603aand arail3603b.Rail3603ais made to have features (e.g., length) that determine the transmitter's generation, here, the transmitter is aGeneration 1.Rail3603bis made to have features that determine which generations of sensors the transmitter will accept, here,

Generations

1, 2, 3, of sensors will be accepted. Atransmitter assembly3606bincludes aGeneration 2 transmitter and has arail3603cand arail3603d.Rail3603cis made to have features (e.g., length) that determine the transmitter's generation, here, the transmitter is aGeneration 2.Rail3603dis made to have features that determine which generations of sensors the transmitter will accept, here,

Generations

1, 2, 3, of sensors will be accepted.

Asensor assembly3612aincludes aGeneration 1 sensor and has aslot3605aand aslot3605b.Slot3605ais made to have features (e.g., length) that determine which transmitter generation(s) the sensor will accept, here,

Generations

1, 2, 3 of transmitters will be accepted.Slot3605bis made to have features that determine the sensor's generation, here, the sensor is aGeneration 1. A sensor assembly3612bincludes aGeneration 2 sensor and has aslot3605cand aslot3605d.Slot3605cis made to have features (e.g., length) that determine which transmitter generation(s) the sensor will accept, here,

Generations

2, 3 of transmitters will be accepted.Slot3605dis made to have features that determine the sensor's generation, here, the sensor is aGeneration 2.

As such, as illustrated in case “I”,sensor assembly3612ahas aslot3605athat accepts

Generations

1, 2, 3 of transmitters and is paired with arail3603aoftransmitter assembly3606a, which has aGeneration 1 transmitter.Slot3605b, which defines aGeneration 1 sensor, is paired withrail3603bthat determines that

sensor Generations

1, 2, 3 will be accepted. As such, there is overlap in both pairs of corresponding slots and rails such that a connection of the sensor assembly and the transmitter assembly is completed. In this regard, the relative lengths of the slots and rails allow the transmitter to rotate enough as indicated by points “A” and “B” so thattransmitter contacts3617aalign with sensor contact pads ofsensor stack3642aas indicated at point “G”. AGeneration 1 sensor connects with aGeneration 1 transmitter.

Likewise, in case “II”,sensor assembly3612aincluding aGeneration 1 sensor connects with atransmitter assembly3506bhaving aGeneration 2 transmitter.Rail3603crotates intoslot3605aandrail3603drotates intoslot3605b. The rails and the slots, as indicated at points “H” and “C”, do not prevent the full rotation of the transmitter assembly such that the transmitter assembly and the sensor assembly connect with each other. In this regard, the relative lengths of the slots and rails allow the transmitter assembly to rotate enough so thattransmitter contacts3617balign with sensor contact pads ofsensor stack3642aas indicated at point “J”. AGeneration 1 sensor connects with aGeneration 2 transmitter.

In case “III”, sensor assembly3612bincluding aGeneration 2 sensor will not connect with atransmitter assembly3606ahaving aGeneration 1 transmitter.Rail3603aruns into the end ofslot3605cat point “D” before thetransmitter contacts3617aline up with sensor contact pads ofsensor stack3542bas indicated at point “K”. In other words, the contact ofrail3603ainto the end ofslot3505cat point “D” blocks the transmitter assembly from rotating all the way into the connection position. AGeneration 2 sensor does not connect or is otherwise not compatible with aGeneration 1 transmitter.

However, in case “IV”, sensor assembly3612bincluding aGeneration 2 sensor connects with atransmitter assembly3606bhaving aGeneration 2 transmitter.Rail3603crotates intoslot3605dandrail3603drotates intoslot3605d. The rails and the slots, as indicated at points “E” and “F”, do not prevent the full rotation of the transmitter assembly such that the transmitter assembly and the sensor assembly connect with each other. In this regard, the relative lengths of the slots and rails allow the transmitter assembly to rotate enough so thattransmitter contacts3617balign with sensor contact pads ofsensor stack3642bas indicated at point “L”. AGeneration 2 sensor connects with aGeneration 2 transmitter.

It should be noted that although lockouts comprised of slots and rails are illustrated according to one or more embodiments herein, other types of lockouts may be created for respective transmitters and sensors with other, shapes, forms, additions, protrusions, etc. For example, lockouts may be of any form, shape, size, depth, etc. and may be positioned on different surface areas of the respective sensor and transmitter assemblies.

FIG. 37 illustrates perspective views of sensor assemblies and transmitter assemblies with different lockout features according to an embodiment of the present disclosure. Different generations of sensors and transmitters are created by changing one or more features of their corresponding lockouts. For example, additional generations are created by changing a diameter measured from the center between the lockout features.

In various embodiments, asensor assembly3712ahas a diameter having a dimension “A” between its lockout features, i.e., between slots. Asensor assembly3712b, which is a different generation thansensor assembly3712a, has a diameter “B” between its slots such that diameter dimension “B” is smaller than “A”. Likewise, a sensor assembly3712chas a diameter “C”, which is smaller than diameters “B” and “A” of

sensors

3712aand3712b, respectively, which corresponds to different generations of sensors. Dimensions “A”, “B” and “C” may have values appropriate to fit the sensor assembly, for example, dimension “A” is approximately 5 mm, dimension “B” is approximately 10 mm, and dimension “C” is approximately 15 mm. In other embodiments, dimension “A” is approximately 16.1 mm, dimension “B” is approximately 13.8 mm, and dimension “C” is approximately 11.5 mm.

Atransmitter assembly3706ahas a diameter having a dimension “A′” between its lockout features, i.e., between rails. Atransmitter assembly3706b, which is a different generation thantransmitter assembly3706a, has a diameter “B′” between its rails such that diameter dimension “B′” is smaller than dimension “A′. Likewise, atransmitter assembly3706chas a diameter “C′”, which is smaller than diameters “B′” and “A” of

transmitters

3706aand3706b, respectively, which are different generations of transmitters. Dimensions “A”, “B”” and “C” have values appropriate to fit the transmitter assembly, for example, dimension “A” is approximately 5 mm, dimension “B′” is approximately 10 mm, and dimension “C” is approximately 15 mm In other embodiments, dimension “A” is approximately 16.1 mm, dimension “B” is approximately 13.8 mm, and dimension “C” is approximately 11.5 mm.

Clocking Lugs

Referring toFIG. 38, a top view of a sensor transmitter assembly with aligned contacts is illustrated according to an embodiment of the present disclosure. As described according to one or more embodiments (see, e.g., the embodiments ofFIGS. 3A-3C, 58A-58C), to connect a transmitter assembly to a sensor assembly, the transmitter assembly is first lowered on to the sensor assembly. Then, the transmitter assembly is rotated, for example in a clockwise direction by approximately 60° to lock it in place. In the embodiment ofFIG. 38, rotating the transmitter assembly aligns the transmitter assembly'scontacts3817 with the sensor assembly's contacts.

FIG. 39 illustrates a top view of a sensor transmitter assembly with non-aligned contacts according to an embodiment of the present disclosure. In some embodiments, because the mechanical mating features of a sensor base of a sensor assembly have 180° rotational symmetry, it is possible to connect the transmitter assembly in an incorrect orientation. In this embodiment,transmitter contacts3917 do not line up with sensor contacts of asensor stack3904.

FIG. 40 illustrates top views of a sensor assembly and a transmitter assembly having features that do not have rotational symmetry according to an embodiment of the present disclosure. Asensor assembly4012 and atransmitter assembly4006 have features such as clocking features that do not have rotational symmetry. For example,sensor assembly4012 has a hole oropening4031 positioned on a first side along a rim or an outline ofsensor assembly4012. Also, anopening4032 and anopening4033 are positioned on a substantially opposite side ofopening4031 along the rim or outline of thesensor assembly4012.Transmitter assembly4006 includes alug4034 positioned on a first side along a rim or an outline of thetransmitter assembly4006.Transmitter assembly4006 also includes alug4035 and alug4036, which are positioned on a substantially opposite side oflug4034 along the perimeter or outline of thetransmitter assembly4006.Opening4031 ofsensor assembly4012 is adapted to receive, engage or connect withlug4034 oftransmitter assembly4006.

Openings

4032 and4033 are adapted to receive, engage or connect with

lugs

4035 and4036, respectively, oftransmitter assembly4006. As such, to prevent thetransmitter assembly4006 from being connected with thesensor assembly4012 in an incorrect orientation, a mechanical interface between a sensor base ofsensor assembly4012 and a transmitter cap oftransmitter assembly4006 includes features such as openings and lugs that do not have rotational symmetry.

It should be noted that although openings and lugs are illustrated in embodiments herein, features to prevent a transmitter form being connected with a sensor in an incorrect orientation can be added such that there is no rotational symmetry, for example, features such as openings and lugs with different depths, shapes or cross-sections, sizes, positioning, or a combination thereof can be used.

Referring toFIGS. 41A-41C, perspective views of a sensor assembly and a transmitter assembly having clocking features are illustrated according to an embodiment of the present disclosure. InFIG. 41A, as described above according to one or more embodiments, atransmitter assembly4106 is lowered into asensor assembly4112.Transmitter assembly4106 has clocking features such as alug4134 and a lug4135 (not all lugs are shown).Sensor assembly4112 has clocking features such as anopening4131 disposed on a first side along an outline ofsensor assembly4112 and

openings

4132 and4133 disposed on a substantially opposite side from the first side along an outline ofsensor assembly4112.

Sensor assembly openings

4131,4132 and4133 are adapted to receive lugs such as

lugs

4134 and4135 of transmitter assembly in a particular orientation. As illustrated in the embodiment ofFIG. 41B, because the clocking features of thesensor assembly4106 and thetransmitter assembly4112 do not have rotational symmetry, the transmitter assembly is lowered all the way onto a sensor base of the sensor assembly in only one correct orientation so that contacts of the transmitter assembly line up with contacts of the sensor assembly as illustrated at points “A” and “B”.FIG. 41C illustrates a transmitter assembly fully lowered onto a sensor assembly.

In alternative embodiments, it should be noted that any appropriate number of clocking features may be used of any shape, depth, positioning or size. Also, in some embodiments, features such as lugs may be positioned on the sensor assembly instead of on the transmitter assembly, and openings may be positioned on the transmitter assembly instead of on the sensor assembly.

Referring toFIGS. 42A-42B, a sensor assembly and a transmitter assembly having clocking features are illustrated according to another embodiment of the present disclosure. InFIG. 42A, as described above according to one or more embodiments, atransmitter assembly4206 is lowered into asensor assembly4212.Transmitter assembly4206 has clocking features such as alug4234 disposed on one side along a rim or an outline oftransmitter assembly4206.Sensor assembly4212 has clocking features such as

openings

4232 and4233 disposed on a side along an outline ofsensor assembly4212.

Sensor assembly openings

4232 and4233 are adapted to receive lugs of transmitter assembly in a particular orientation. As illustrated in the embodiment ofFIG. 42B, because the clocking features of thesensor assembly4212 and thetransmitter assembly4206 do not have rotational symmetry, the transmitter assembly is not lowered all the way onto a sensor base of thesensor assembly4212 in an orientation wherelug4234 oftransmitter assembly4206 does not line up with

openings

4232 and4233 ofsensor assembly4212.Transmitter assembly4206 is only lowered ontosensor assembly4212 in one correct orientation so that contacts of the transmitter assembly line up with contacts of the sensor assembly. Accordingly, in this embodiment, the clocking features physically block the transmitter assembly from being dropped all the way onto the sensor assembly base when it is in the incorrect orientation.

Methods

Referring toFIG. 43, a flowchart illustrates a method for forming a sensor transmitter assembly according to an embodiment of the present disclosure. It should be noted that the method ofFIG. 43 may be implemented by the sensor transmitter assembly illustrated, for example, at least in the embodiments ofFIGS. 1A-1B, 3A-3C, 13, 15A-15C, 20, 22, 23, 27A-27C, 29A-29B, 33A-33B, 38, and 41A-41C, 56A-56B,58A-58B,67,74 and75.

Inblock4302, a transmitter assembly is positioned on a sensor assembly, where at least one interface of the transmitter assembly matches at least one interface of the sensor assembly. For example, the transmitter assembly is initially lowered onto the sensor assembly where an opening substantially centered through the transmitter assembly fittingly engages with a cap extending from the sensor assembly. In various embodiments, interfaces such as clocking features are used to ensure that the transmitter assembly is positioned in a correct orientation on the sensor assembly such that contact pads of the sensor assembly match a location or line up with contacts of the transmitter assembly. The clocking features prevent the transmitter assembly from being lowered all the way down onto the sensor assembly if the transmitter is in the wrong orientation.

Inblock4304, a connection between the transmitter assembly and the sensor assembly is completed by a rotation motion, wherein at least one contact of the transmitter assembly connects with at least one corresponding contact pad of the sensor assembly. In this regard, a patient uses an intuitive rotation motion (e.g., a clockwise motion) to lock the transmitter assembly to the sensor assembly. One or more interfaces, for example, tabs, slots and snap arms ensure that the transmitter assembly and the sensor assembly connect with each other axially and rotationally. In various embodiments, mechanical lockouts are used to prevent certain generations of sensor assemblies from connecting with certain generations of transmitter assemblies such that, for example, an interface of the transmitter assembly such as a rail having a certain length interferes with completing a connection as the transmitter assembly is rotated into a slot of the sensor assembly.

Referring now toFIG. 44, a flowchart illustrates a method for connecting a sensor transmitter assembly according to an embodiment of the present disclosure. It should be noted that the method ofFIG. 44 may be implemented by the sensor transmitter assembly illustrated, for example, at least in the embodiments ofFIGS. 5A-5C, 16-27, 60A-60C, 69A-82.

Inblock4402, a sensor combination is formed for a sensor transmitter assembly. In an embodiment, windows are cut or otherwise created through a first contact pad head of a first sensor where at least one window results in at least one active WE contact pad on the first sensor. Also, windows are cut or otherwise created through a second contact pad head of a second sensor where at least one window of the second contact pad results in at least one active WE contact pad on the second sensor, where the first sensor and the second sensor have mirrored window patterns across each respective contact pad head. The first sensor is placed back to back with the second sensor where the windows of the first sensor and the windows of the second sensor are aligned and provide a signal path between contact pads of the first contact pad head and the second contact pad head.

In other embodiments, sensor combinations are created by using, for example, a rigid flex connector, a flex connector integrated with a lower sensor, or a flex connector integrated with a sensor where the sensors interlace as will be described in more detail below according to the embodiments illustrated inFIGS. 69A-82.

Inblock4404, a sensor contact stack is formed by placing the sensor combination between a first elastomeric connector and a second elastomeric connector.

Inblock4406, a transmitter assembly is connected to the sensor assembly, where the sensor connector stack is compressed between at least one transmitter contact and a sensor base of the sensor assembly, such that a signal path extends to the transmitter contact(s).

Benefits of Sensor Transmitter Arrangement

Advantageously, a device having a sensor transmitter assembly according to one or more embodiments of the present disclosure has many features that provide many benefits to a patient as well as to performance and assembly of the device. For example, Table 2 below summarizes various non-limiting features of the device along with corresponding potential benefits.

TABLE 2

	On-body	Connection	On-Body	Use Model
Feature	Stability	Robustness	Comfort	Simplicity	Aesthetics

Large, stretch pad	X		X
Patch bonded to entire	X		X	X
device outline
Low profile	X		X		X
No overtape required	X		X	X	X
Centered sensor	X			X
Multi-point connection		X		X
Solid transmitter		X
contacts
Elastomeric sensor		X
contacts
Smooth, continuous			X		X
surfaces
Smooth, continuous			X		X
edges
Reduced volume			X		X
Radial symmetry				X	X
No-look, twist				X
connection

Disposable Insertion Tool Use Model

Referring toFIG. 45A, a perspective outer view of a single-use, disposable insertion tool is illustrated according to an embodiment of the present disclosure. A disposable insertion tool4500 (also referred to as “insertion device”) according to one or more embodiments can be carried, shipped, or stored as an integrated, single unit as illustrated.Insertion device4500 includes a top portion orplunger4502 and a bottom portion orlock collar4504 coupled to each other.Insertion device4500 houses contents including one or more components, for example, a sensor assembly, a striker, a needle hub or carrier that holds a piercing member (e.g., a needle) and associated mechanisms and packaging. Alid4506 is provided at an end oflock collar4504 to keep the contents in place or otherwise protect the contents. For example,lid4506 protects the contents against dirt, dust, debris, etc.Lid4506 also protects against accidental firings of the contents such as the piercing member (e.g., needle). In various embodiments,lid4506 seals an outline of a bottom surface oflock collar4506.Lid4506 covers an entire outline oflock collar4504.

Referring toFIG. 45B, a perspective cutout view of the single-use, disposable insertion tool ofFIG. 45A is illustrated according to an embodiment of the present disclosure.Insertion device4500 includes asensor assembly4508 housed inside a top portion orplunger4502 ofinsertion device4500.Sensor assembly4508 is in a pre-cocked position. A mountingbase4512 is disposed on a bottom surface ofsensor assembly4508. Mounting base4512 covers at least an entire outline of the bottom surface ofsensor assembly4508. In various embodiments, mountingbase4512 is positioned to fit within an entire inner outline of bottom portion oflock collar4504 ofinsertion device4500. In particular embodiments, mountingbase4512 includes an exposed adhesive on a bottom side, that is, a first side of mountingbase4512 attaches tosensor assembly4508 and a second side is exposed. In other embodiments, mountingbase4512 is made of a flexible material, a gauze-like material, or a solid material such as a plastic, a metal, etc.

FIGS. 46A-46B are bottom perspective views of an insertion device illustrating a first step for a use model of the insertion device according to an embodiment of the present disclosure. In various embodiments, a user uses aninsertion device4500, which is an integrated, single unit device, to allow the user to position and subcutaneously implant a sensor into the user's body. For example, the user usesinsertion device4500 to implant a glucose sensor subcutaneously/transcutaneously.

First, as illustrated inFIG. 46A, a user ofinsertion device4500 opensinsertion device4500 by peeling or otherwise removing alid4506 as indicated by arrow “A”. For example, the user removeslid4506 with a simple pulling with the hand or other appropriate tool.Lid4506 can be of any appropriate material to provide protection or cover a bottom side of alock collar4504 ofinsertion device4500, for example, plastic, paper, and/or the like.FIG. 46B illustratesinsertion device4500 having the bottom side oflock collar4504 open, that is, withoutlid4506 attached.

FIGS. 47A-47B are perspective views of an insertion device illustrating a second step for a use model of the insertion device according to an embodiment of the present disclosure. As illustrated inFIG. 47A, a rotation or twisting motion, for example in a counterclockwise direction as indicated by arrow “A” is used to align a marking4716 (e.g., a downward arrow or other appropriate marking) ofplunger4502 with a corresponding marking4718 (e.g., an upward arrow or other appropriate marking) oflock collar4504. In various embodiments, the user performs the rotation motion as indicated by arrow “A” while applying a downward force (e.g., pushing) onplunger4502. As such, two unlocking directional forces are used, one rotating force and one downward force (push). In this way, the two forces, for example, two concurrent moves of pushing and rotating, keep the lock collar from easily or accidentally rotating or unlocking so that an accidental trigger is prevented, for example an accidental trigger of a piercing member (e.g. a needle), thus increasing safety and avoiding wasting of an insertion device.FIG. 47B illustrates marking4716 ofplunger4502 and marking4718 oflock collar4502 lined up in response to the user applying forces such as two concurrent moves to push and rotate to unlocklock collar4502.

Referring now toFIG. 48, a perspective view of an insertion device illustrates a third step for a use model of the insertion device according to an embodiment of the present disclosure. Onceplunger4502 andlock collar4504 are unlocked for example as indicated by

markings

4716 and4718 lining up as described above with respect to the embodiment ofFIG. 47B, the user placesinsertion device4500 against an insertion site. The user selects the insertion site to position and subcutaneously implant a sensor into the user's body. For example, the user usesinsertion device4500 to implant a glucose sensor subcutaneously/transcutaneously. Once the user positionsinsertion device4500 on the selected insertion site, the user applies a downward force on at least of portion ofplunger4502, for example, the user depressesplunger4502 at a top surface ofplunger4502 as indicated by arrow “A”.Insertion device4500 includes components including a sensor (not shown) that is inserted into the user's body as a result of the user pressing onplunger4502 by a certain extent (i.e. travel or distance). In an embodiment, the sensor is inserted whenplunger4502 is depressed 0.30 inches. In other embodiments, the sensor is inserted whenplunger4502 is depressed 0.2 inches, 0.4 inches, 0.5 inches, or any other appropriate distance. In an embodiment, the user uses a predetermined minimum force to depressplunger4502 so that the sensor is inserted into the user's body. For example, the user uses a minimum plunger spring force of 2.51 bf. to insert the sensor. Notably, a force less than a certain minimum force does not allow the sensor to be implanted into the body. In this way, minimum plunger force and travel or distance prevent accidental firing or firing of the insertion device in mid-air. Due at least in part to the symmetrical shape of the insertion device (e.g., radially symmetrical), the user can insert a component such as a sensor using just one hand, without having to look at an insertion site, which allows more possible insertion sites such as the user's back, the back of the arm, etc. No orientation of the insertion device to the body is required.

Referring toFIGS. 49A-49B, perspective views of an insertion device illustrates a fourth step for a use model of the insertion device according to an embodiment of the present disclosure. After a user unlocks, positions an insertion device on an insertion site, depressesplunger4502 of the insertion device with a certain force and/or for a certain distance so that a sensor is subcutaneously implanted into the user's body, the user then releasesplunger4502 and pulls the insertion device away from the insertion site. In this regard, as illustrated in the embodiment ofFIG. 49A, the user releasesplunger4502 as indicated by arrow “A”. For example, the user removes pressure fromplunger4502 by, for example, removing the user's finger or another tool from applying force on a top surface ofplunger4502. Then, as illustrated inFIG. 49B, the user removes the insertion device away from the insertion site as indicated by arrow “B”. As illustrated inFIG. 49B, asensor assembly4508 is automatically left behind on the insertion site, and is ready for further use, for example, ready for transmitter connection. In various embodiments, a mountingbase4512 fastenssensor assembly4508 to the user's body, for example, by using an adhesive that adheres to the user's body. It should be noted that as a result of the user releasing or pulling the insertion device away from the insertion site, a needle component housed in the insertion device automatically retracts as will be described in more detail below.

As such, embodiments of the present disclosure provide a simple use model for an insertion device. First, a user of an insertion device according to one or more embodiments simply opens the insertion device by removing a lid that covers or protects a bottom of the insertion device. Second, the user uses a rotation or twist action to unlock a lock collar of the insertion device. In an embodiment, unlocking is indicated by lining up a marking on a lock collar with a corresponding marking on a plunger of the insertion device. Third, the user positions the insertion device on a selected insertion site and pushes the plunger downward on the selected insertion site. In an embodiment, the user uses a minimum pushing force for a certain minimum travel or distance to insert a sensor into the body of the user at the insertion site. And fourth, the user releases the plunger and removes the insertion device away from the insertion site leaving behind the sensor at the insertion site, where the sensor remains fastened to the user's body via a mounting base.

Advantageously, embodiments of the present disclosure provide a simple use model for an insertion device for a user that requires only a few simple steps. For example, the user uses only a few steps to insert a sensor into a selected insertion site. No cocking is required. No removing liners is required, no buttons or other interfaces are required, no manually removing a needle hub is required, instead, a needle pops up and is retained automatically. No fine motor skills by the user are required. The user uses the insertion device to insert a component such as a sensor with one hand, without having to look at an insertion site, which allows more possible insertion sites such as the user's back, the back of the arm, etc. No orientation of the insertion device to the body is required. And no work surface is required.

In addition, embodiments of the present disclosure provide error-proof insertion. Push-to-fire mechanism guarantees that sufficient force is applied against an insertion site. Enough force is needed to trigger the insertion device. Also, full needle penetration is ensured. The sensor is fastened to the skin, e.g., the sensor is bonded with adhesive to the skin. Sequence of sensor insertion and needle retraction is guaranteed by the mechanism as will be described in more detail below.

Furthermore, embodiments of the present disclosure reduce the number of devices that a user carries to insert a sensor. For example, an insertion device according to one or more embodiments integrates components such as a sensor, a needle, a needle hub, packaging, etc. into one device instead of the user having to carry each component separately. Also, as a result, there is less waste produced with the use of a single integrated device than with multiple devices individually packaged.

Mechanism for Insertion Device

Referring toFIGS. 50A-50B, perspective views for unlocking an insertion device are illustrated according to an embodiment of the present disclosure. As described above according to one or more embodiments, aninsertion device5000 includes aplunger5002 and alock collar5004.Plunger5002 includes one ormore ribs5022 spaced along an outline of a side or a bottom surface ofplunger5002. For example, four, six, eight, or any appropriate number ofribs5022 can be evenly spaced along the outline of the bottom surface ofplunger5002.Lock collar5004 includes one ormore clearance slots5024 positioned around an outline of a side or a top surface oflock collar5004. InFIG. 50A,plunger5002 ofinsertion device5000 is blocked or locked by at least onerib5022.Insertion device5000 is in such a locked position, for example, when theinsertion device5000 is being transported or stored. When a user desires to use the insertion device to implant a sensor, for example a glucose sensor at an insertion site on the body of a user, the user has to first unlock the insertion device. As illustrated inFIG. 50B, the user rotatesplunger5002 for example in a counterclockwise direction as indicated by arrow “A”. As a result of the rotation,clearance slots5024 align withribs5022 oflock collar5004. The alignment ofclearance slots5024 withribs5022 unblocks or unlocksplunger5002 so that the user can depressplunger5002.

Referring toFIG. 51, a cutout view of the insertion device ofFIGS. 50A-50B is illustrated in a cocked position according to an embodiment of the present disclosure.Insertion device5000 is configured to be in a cocked position, for example, wheninsertion device5000 is transported, stored, or otherwise not in use. As described above according to one or more embodiments,insertion device5000 includes aplunger5002 coupled with alock collar5004.Insertion device5000 also includes astriker5136 that is configured to keepinsertion device5000 in a cocked position such thatstriker5136 is kept from firing. In that regard,insertion device5000 includes astriker spring5138 that is captured betweenplunger5002 andstriker5136 when it is in a cocked position. Self-lockingstriker snap arms5142 keepstriker5136 cocked. To be fired, self-lockingstriker snap arms5142 are positioned (e.g., turned) to enter a groove to allowstriker5136 to snap down as will be described in more detail below. Asensor assembly5108 having or adapted to fit a piercing member5110 (e.g., a needle) therethrough is also cocked and housed withininsertion device5000, for example, at a bottom side within an interior volume or portion oflock collar5004. Aneedle carrier spring5144 is captured betweenstriker5136 and aneedle carrier5146. Self-releasingsnaps5148 keepneedle carrier5146 cocked. Notably,plunger5002 preventssnaps5148 from re-positioning, e.g., flexing outwards, and releasingneedle carrier5146.

Referring toFIGS. 52A-52B, cutout views of the insertion device ofFIGS. 50A-50B are illustrated in an insertion position according to an embodiment of the present disclosure. A user can useinsertion device5000 to insert a sensor at an insertion site on the user's body. In this regard, the user depressesplunger5002 using the user's finger, hand or other appropriate tool. As illustrated inFIG. 52A, as a result of theuser depressing plunger5002,striker spring5138 is compressed. Also,plunger ribs5152 deflect self-lockingstriker snap arms5142, for example, self-lockingstriker snap arms5142 turn as indicated by arrows “A”, allowing firing ofinsertion device5000.FIG. 52B illustratesstriker5136 in the fired position withstriker spring5138 in a released position. Upon firing ofinsertion device5000, piercingmember5110 ofsensor assembly5108 is inserted into a user's body.

Referring toFIGS. 53A-53B, cutout views of the insertion device ofFIGS. 50A-50B re illustrated in a retraction position according to an embodiment of the present disclosure. As illustrated inFIG. 53A, once a user firesinsertion device5000 at a selected insertion site, for example, by depressingplunger5002 as described above,striker5136 is in a fired position. Withstriker5136 in the fired position, the user then releasesplunger5002, for example, by removing the user's finger, hand or other tool fromplunger5002. Releasingplunger5002 freessnap arms5155 to turn, for example flex outwards as indicated by arrows “A”. As a result, as illustrated inFIG. 53B,needle carrier5146 is retracted. In this regard,needle carrier spring5144 expands and retractsneedle carrier5146.Needle carrier5146 having piercingmember5110 is retracted such that it is encapsulated well insideinserter device5000.

Referring toFIG. 54, a cutout view of the insertion device ofFIGS. 50A-50B is illustrated in a released position according to an embodiment of the present disclosure. Once a user firesinsertion device5000 such that a mountingbase5412 adheressensor assembly5108 to the user's body, the user pullsinsertion device5000 away from the body, thus releasingsensor assembly5108.

Referring now toFIG. 55, a flow chart illustrates a method for an insertion device mechanism according to an embodiment of the present disclosure. In various embodiments, the method ofFIG. 55 can be implemented by the insertion device illustrated inFIGS. 50A-54.

Inblock5502, an insertion device includes a locking mechanism. The locking mechanism protects the insertion device from accidentally firing or other potential safety issues. As described above according to one or more embodiments, the insertion device includes a plunger having one or more clearance slots and a lock collar having one or more ribs. The one or more ribs on the lock collar block the plunger. Rotating the plunger aligns the clearance slots of the plunger with the ribs of the lock collar, thus unlocking the insertion device such that a user can depress the plunger.

Inblock5504, upon unlocking of the insertion device, the insertion device is fired at an insertion site in response to a user pressing the plunger. In this regard, as described above according to one or more embodiments, pressing the plunger compresses a striker spring and plunger ribs deflect striker snaps, e.g., self-locking striker snap arms, thus firing the insertion device.

Inblock5506, upon firing of the insertion device, a piercing member is caused to insert a sensor of a sensor assembly into the body of the user and a sensor assembly adheres to the body of the user.

Inblock5508, a needle carrier having the piercing member is retracted in response to the user releasing the plunger. The piercing member is retracted such that it is encapsulated well inside the insertion device.

Inblock5510, with the sensor assembly adhered to the user's body, releasing the sensor assembly in response to the user pulling away the insertion device.

In various embodiments, a disposable insertion tool piercing member protection mechanism may be provided as will be described in more detail below with respect toFIGS. 87A-96 according to one or more embodiments. Once the insertion device has been used, that is, released and pulled away from the user's body, a disposable insertion tool needle mechanism alleviates potential accidental exposure of a tip of a piercing member (e.g., needle). The piercing member remains protected inside the inserter device even if the user attempts to depress the plunger and striker on the used insertion device. That is, according to one or more embodiments, the piercing member (e.g., needle) is prevented from being exposed by preventing the plunger and striker from being fully depressed again once the insertion tool has been used.

Sensor Transmitter Assembly Alternative Embodiments

FIG. 56A is a top view of a sensor transmitter assembly as a single unit having two compression areas according to an embodiment of the present disclosure.FIG. 56B is a side view of the sensor transmitter assembly ofFIG. 56A according to an embodiment of the present disclosure.

compression areas

142aand142b, also referred to as “snap arms”. As illustrated in the embodiment ofFIG. 56B,sensor transmitter assembly100aincludestransmitter assembly106apositioned on top of asensor assembly112aas a single unit.Transmitter assembly106aandsensor assembly112aattach at two edges, for example at two edges corresponding to

compression areas

142aand142b. In various embodiments,

compression areas

142aand142b(or snap arms) are included or located on either side of a base ofsensor assembly112a, for example evenly spaced apart substantially along an outer rim or outline of the base ofsensor assembly112a. A user can turn or apply a rotation motion to lock the sensor transmitter assembly into place. For example, the user can turn or rotatetransmitter assembly106aontosensor assembly112ain a first direction (for example, in a clockwise direction), which automatically squeezes or compresses

compression areas

142aand142b. Conversely, to disconnect, the user can squeeze (e.g., press inwards) the compression areas (or snap arms) while turning or applying a rotation motion. For example, when disconnectingtransmitter assembly106afromsensor assembly112a, the user squeezes or compresses

compression areas

142aand142bwhile rotating in an opposite direction from the first direction, for example in a counterclockwise direction. Squeezing of

compression areas

142aand142b(or snap arms) and applying the rotation motion provides a double fail safe mechanism for disconnecting thesensor transmitter assembly100aby using a mechanism that is intuitive to a user. Two compression areas make it easy for the user to squeeze and turn at the same time. However, it should be noted thattransmitter assembly106aandsensor assembly112acan attach at any number of edges corresponding to respective compression areas or snap arms as appropriate, for example, at two edges corresponding to two compression areas as illustrated inFIG. 56A, or at 4 edges, 5 edges, 6 edges, etc.

Compression areas

142aand142b(or snap arms) on the base ofsensor assembly112aare designed to be self-locking. That is, if the user tries to disconnecttransmitter assembly106ajust by rotating it and without manually squeezing the snap arms inwards, then the rotation motion causes the snap arms to flex outwards and lock even harder againsttransmitter assembly106a. Ifcompression areas142 and142b(or snap arms) were not self-locking, then it would be possible for the user to rotatetransmitter assembly106ahard enough to unlock the snap arms, which, in such case, would defeat the double fail-safe feature.

A surface, e.g., a top surface ofsensor transmitter assembly100aincludes

indicators

152,154 and156. Alignment of the indicators with respect to each other, e.g., as a result of a rotation motion, indicates whether the sensor transmitter assembly is in a locked or an unlocked position. For example, whenindicator152 is aligned withindicator156, the sensor transmitter assembly is in a locked position. Whereas whenindicator152 is aligned withindicator154, the sensor transmitter assembly is in an unlocked position. In this embodiment,indicator152 is in the shape of a filled-in triangle,indicator154 is in the shape of a clear triangle, andindicator156 is in the shape of a dash or a line to indicate alignment with eitherindicator152 orindicator154. It should be noted that the characteristics of

indicators

152,154 and156 can be of any shape, size, form, color, etc. to indicate alignment, and can be placed on any appropriate location on the sensor transmitter assembly such as on a side surface, etc.

The overall shape ofsensor transmitter assembly100aaccording to one or more embodiments is substantially round and has smooth footprint edges, which prevent potential wear issues such as snagging on the patient's clothing that may be caused by, for example, sharp, pointy edges. Also, smooth footprint edges help improve comfort of wear.Sensor transmitter assembly100ais fastened by a mounting base or patch102athat adheres to the user's skin.

FIG. 57A is an exploded top perspective view of the sensor transmitter assembly illustrated inFIGS. 56A and 56B according to an alternative embodiment of the present disclosure.FIG. 57B is an exploded bottom perspective view of the sensor transmitter assembly illustrated inFIGS. 56A and 56B according to an embodiment of the present disclosure. As illustrated inFIGS. 56A and 56B the components of thesensor transmitter assembly100 may be coupled together as a single unit.

As described above, the embodiment ofFIG. 57A illustrating an exploded top view of the sensor transmitter assembly generally includes atransmitter assembly106aand asensor assembly112a.Transmitter assembly106aincludes anopening216athat is adapted to engage with acap214aofsensor assembly112a. In that regard,transmitter assembly106ais initially lowered ontosensor assembly112asuch that opening216aoftransmitter assembly106 is positioned to fitcap214aofsensor assembly112a. In an embodiment,indicator154 oftransmitter assembly106acan be aligned withindicator156 ofsensor assembly112awhen engagingopening216awithcap214a. A solid connection oftransmitter assembly106atosensor assembly112ais completed by applying an intuitive rotation motion, which automatically squeezes inward or compresses the snap arms or

compression areas

142aand142bthat are positioned on a base ofsensor assembly112a.

As illustrated inFIG. 57B,transmitter assembly106aincludes abottom surface211a having at least one interface such as a rail, tab orsnap arm5703, and accommodates various components including at least one electronics module.Sensor assembly112aincludes at least one interface such as slot5705 (illustrated inFIG. 57A) adapted to engage, match or otherwise receive corresponding interfaces such as rails, tabs or snap arms disposed ontransmitter assembly106a. It should be noted that there can be any number of interfaces such as rails, tabs or snap arms and corresponding interfaces such as slots (e.g., 3, 4, etc. on a corresponding surface) and can be positioned on respective surfaces of the transmitter assembly and the sensor assembly to allow engagement or attachment with each other. Also, the characteristics of the interfaces such as rails, tabs or snap arms and corresponding slots can be of any appropriate shape, size, depth, etc. to allow engagement or attachment with each other.

As described above for example with respect to the embodiments ofFIGS. 2A-2B, a mounting base (or patch)102ais a large, stretchy patch that affixes thesensor assembly112ato the skin of the patient. Mounting base or patch102ahas a bottom surface (as shown inFIG. 57B) that is adapted to be attached to the skin of the patient using any appropriate attachment techniques, for example, an adhesive (e.g., a fluid adhesive, a spray adhesive, etc.), staples, or the like. In various embodiments, mounting base or patch102ahas a top surface that is bonded to the entire device outline, not just to certain edges of the device, thus providing on-body stability. In various embodiments, glue, ultrasonic welding, etc. can be used for bonding.

Referring toFIGS. 58A-58C, perspective side views for mechanically connecting a sensor assembly to a transmitter assembly are illustrated according to an alternative embodiment of the present disclosure. Initially, as illustrated in the embodiment ofFIG. 58A, atransmitter assembly106ais positioned, for example, lowered onto asensor assembly112aas indicated by downward arrow “A”. In that regard, an interface such as anopening216aoftransmitter assembly106ais lined up with, fits, or otherwise matches an interface such as acap214aofsensor assembly112a. Also, anindicator154 located ontransmitter assembly106ais aligned with anindicator156 ofsensor assembly112a. As described above according to one or more embodiments, one or more interfaces, e.g., rails located on a bottom surface oftransmitter assembly106aengage into one or more corresponding interfaces, e.g.,slots5805 ofsensor assembly112a. In this embodiment, there are two rails and two corresponding slots that provide a keyed structure such that the transmitter assembly drops in and lines up (e.g., as indicated by aligningindicators154 and156) in a particular way (not randomly) so that it can be locked and does not move around.

As illustrated inFIG. 58B, aftertransmitter assembly106ais initially positioned together axially withsensor transmitter112asuch thatindicator154 is aligned withindicator156, a push or twist action (e.g., a clockwise rotating motion), as indicated by arrow “B”, is used to connecttransmitter assembly106atosensor assembly112atogether rotationally. As illustrated inFIG. 58C, the rotating motion alignsindicator156 withindicator152 indicating the locking of the sensor transmitter assembly in place. Conversely, a squeeze at the compression areas together with a rotation motion (e.g., in a counterclockwise direction) is used to disconnecttransmitter assembly106afromsensor assembly112a. It should be noted that in other embodiments, a clockwise rotating motion disconnects the transmitter assembly to the sensor assembly, and a counterclockwise rotation motion connects the transmitter assembly to the sensor assembly. As such, according to embodiments herein,transmitter assembly106arests completely on top ofsensor assembly112a. This results in little relative movement being possible between the sensor assembly and the transmitter assembly. Stable electrical connections are also ensured.

Advantageously, a twist or rotating action along with compressing at the compression areas provides a double fail safe connection mechanism, is generally intuitive to a patient, and allows the patient to handle the sensor transmitter assembly with one hand without the patient having to look at an insertion site. This allows the patient to place and wear the sensor transmitter assembly on more locations on the body, even on locations where the patient has no visibility such as on the patient's back.FIG. 58C illustrates the sensor transmitter assembly as would be worn by the patient on-body as one unit.

Referring toFIG. 59, an exploded view of a sensor assembly is illustrated according to an alternative embodiment of the present disclosure.

As described above according to one or more embodiments,sensor assembly112aincludes abase5919 having at least one interface such asslots5905 adapted to engage with corresponding interfaces such as rails of a transmitter assembly.Sensor assembly112ahas components including without limitation a mountingbase102 such as an adhesive patch,sensor base5919 havingslots5905, asensor head cavity5915 and acap cavity5918, anouter seal5903, asensor module5904, anelastomeric connector5902, at least oneinner seal5906, acap5909, an o-ring5907 and aneedle hub5922.Sensor head cavity5915 is adapted to fittingly receive and provide support tosensor module5904 andelastomeric connector5902 as will be described in more detail below, for example, with respect to the embodiments ofFIGS. 60A-60C.Cap cavity5918 is adapted to fit or accommodate at least oneinner seal5906 that also provides a fluid seal forsensor module5904. Anouter seal5903 fits aroundsensor base5919 and provides water tightness forsensor assembly112a.

FIGS. 60A-60C illustrate views for affixing a sensor head and an elastomeric connector to a sensor base of a sensor assembly according to an alternative embodiment of the present disclosure. InFIG. 60A,sensor base6019 includes a sensor head cavity6015 (see also,FIG. 59) formed thereon that holds in place asensor module6004.Sensor module6004 is positioned insensor head cavity6015 and can be fastened by using suitable fastening techniques such as double sided tape, adhesive, molded glue, a snap fit, laser weld, or the like. Configurations forsensor module6004 will be described in more detail below according to one or more embodiments.

InFIG. 60B, anelastomeric connector6002 is placed on top ofsensor module6004. In various embodiments,elastomeric connector6002 is retained by any suitable structure such as a spring, a snap fit, etc. In one or more embodiments, the retaining structure provides dead volume forelastomeric connector6002 to expand into in response to a transmitter assembly being connected to the sensor assembly.

FIG. 60C is a perspective side view of the elastomeric connector fitted into the sensor head cavity ofsensor base6019. In this embodiment, a top cross section ofelastomeric connector6002 is square, which avoids having to orient the elastomeric connector in any particular direction.

FIG. 61 illustrates a perspective partial top view of a sensor assembly according to an alternative embodiment of the present disclosure. As described above according to one or more embodiments, asensor base6119 includes at least one interface such as sensor slot(s)6105 and asensor head cavity6115 adapted to receive or accommodate (e.g., appropriately sized, shaped, positioned, etc.) a sensor module and anelastomeric connector6102. Atop portion6125 ofsensor portion6104 extends directly straight at substantially a 90 degree angle (without further bending) into an opening ofcap cavity6118. Two identical inner seals orrings6106 sandwich a portion of substrate of the sensor module, e.g.,top portion6125 of sensor extension orportion6104 as will be described in more detail below according to one or more embodiments.

FIGS. 62A-62E illustrate perspective side views of an interface for a sensor assembly including a sensor base, a sensor portion, a piercing member or needle, a cap cavity and a cap according to an alternative embodiment of the present disclosure. InFIG. 62A, a top part ofsensor portion6204 is disposed in anopening6206 extending along asensor base6219. Substantially identicalinner rings6207 sandwich a portion of the sensor substrate, i.e., at least aportion6215 of a top ofsensor portion6204.Top sensor portion6215 is angled at an angle “A°”, for example approximately 90 degrees (see alsoFIG. 62B). As such, this part of the sensor portion has substantially a straight angle making this sensor portion easier to mold.Inner rings6207 have a substantially square cross section when they are not compressed, which avoids slipping over each other.

As illustrated inFIG. 62B, upon compression for example by positioning acap6209 on top ofsensor base6219, innersquare rings6207 expand so that a sensor fold is on a fluid side of a seal, thus, there is no polyimide-against-polyimide gap to seal against. No glue, curing or other fastening techniques are needed. In this embodiment, everything is compressed together and supported. As illustrated inFIG. 62C, a piercing member such as aneedle6210 is positioned though opening6206 ofsensor base6219.

Referring toFIG. 62D, a perspective partial side view of a sensor assembly showing an interface of a sensor portion, a sensor base, a piercing member or needle and a cap is illustrated according to an alternative embodiment of the present disclosure.FIG. 62D illustrates an interface of asensor portion6204, asensor base6219, a piercing member orneedle6210 and acap6209.Cap6209 includes a hole or opening adapted to accommodateneedle6210 throughcap6209. The needle hole or opening extends throughneedle hub6222 and is designed to fit all needle profiles including micro needles, HTI, and the like.

FIG. 62E is a detail of the interface illustrated inFIG. 62D according to an alternative embodiment of the present disclosure.FIG. 62E illustrates the interface at a point “B”. Asensor clamp6214 is located in an interior ofneedle6210 to resist sensor pullups.Sensor clamp6214 clamps down onsensor portion6204. The needle does not touchsensor portion6204. In various embodiments, after insertion into a patient's body, when the needle is pulled out ofsensor base6219, it pullssensor portion6204 upwards at areas indicated by arrows “c” and “d”.Sensor clamp6214 holdssensor portion6204 down at an area indicated by arrow “e”. This puts the length of the sensor portion that is between upward pulling arrows “c” and “d” and downward pulling arrow “e” in tension. Because the sensor portion is in tension, the needle slipspast sensor portion6204, allowingsensor portion6204 to stay in place as the needle retracts. Withoutclamp6214,sensor portion6204 would be carried along with the needle when the needle is retracted, pullingsensor potion6204 out of the patient's body.

FIG. 63 illustrates a sensor transmitter assembly with seals that improve water tightness according to an alternative embodiment of the present disclosure. Acap6309 of a sensor assembly has at least one cavity formed at each lateral side as further illustrated in detail “A”. Aradial seal6323 is placed in a respective cavity formed on the cap. In various embodiments,radial seals6323 have a round shape, but any appropriate shape can be used. In various embodiments, a side portion ofsensor base6319 further includes at least one cutout for example in an “L” shape or at substantially a 90 degree angle, or at any other appropriate shape or angle adapted to receive aportion6327 of atransmitter assembly6306. Acrush seal6322 is placed in a respective cutout formed at a connection betweenportion6327 oftransmitter assembly6306 andsensor base6319 as further illustrated in detail “B”. In one or more embodiments, crush seals6322 are held in place with friction. In various embodiments, crush seals6322 have a square cross section to prevent any rolling or other type of movement. In this way, potential leak paths are sealed byradial seals6323 and bycrush seals6322. As such, water (or other liquid or fluid) tightness of the sensor transmitter assembly is ensured.

Referring toFIG. 64, an exploded view of a transmitter assembly is illustrated according to an alternative embodiment of the present disclosure.

Atransmitter assembly6306 includes without limitation atransmitter shell6307 adapted to be positioned, attached or otherwise connected with atransmitter cap6308.Transmitter shell6307 includes a top surface including markings or

indicators

152 and154 as described above according to one or more embodiments.Transmitter cap6308 includes at least one interface, e.g., arail6303 adapted to engage with at least one corresponding interface, e.g., a slot of a second assembly such as a sensor assembly as described above according to one or more embodiments.Transmitter shell6307 includes ashell subassembly6312 including a custom portion that houses, for example, a custom battery and a substrate portion on which a PCB board having various electronic components is disposed as will be described in more detail below.Transmitter cap6308 includes acap subassembly6422 having openings or cavities that are adapted to respectively accommodate various components including, e.g., substrates,contacts6328a(e.g., 4 contacts) and6328b(e.g., 6 contacts), and

elastomeric connectors

6332aand6332b.

Referring toFIG. 65A a perspective bottom view of a transmitter shell subassembly is illustrated according to an alternative embodiment of the present disclosure. Atransmitter shell subassembly6412 includes, without limitation, components including acustom battery6414, for example a custom D-shaped battery (e.g., 36 mAh) adjoining aPCB base6418 on which various components are disposed. In various embodiments,PCB base6418 is disposed on a portion, for example approximately one half portion, ofshell subassembly6412 andcustom battery6414 is disposed on another portion, for example approximately the other half portion, of the subassembly. In various embodiments, connection points6427 provide connection points forPCB base6418. For example, connection points6427 include materials such as plastic that can be heated and melted to connect the PCB base. In this embodiment, sixconnection points6427 are illustrated, however, it should be noted that any number ofconnection points6427 can be used as appropriate. Advantageously, the components e.g.,battery6414 andPCB base6418 are compressed, are held together by friction, or otherwise fit together such that no solder or other connections are necessary for the subassembly. In this way, the arrangement minimizes dead volume and reduces the height of the subassembly.

FIG. 65B illustrates a perspective top view of thetransmitter shell subassembly6412. In one or more embodiments,custom battery6414 is custom made to fit together withPCB6418. It should be noted that in various embodiments the subassembly fits various components as necessary, which are designed in various shapes or sizes to fit in the subassembly. For example, in alternative embodiments, there are one or more custom batteries (e.g., 1, 2, etc.) that are of particular shapes to fit together with a PCB of a particular shape and occupy less than half or more than half (e.g., one quarter, three quarters, etc.) of the subassembly. In various embodiments,custom battery6414 can be of any appropriate chemistry, for example, a Lithium battery. Also, in various embodiments, options for connecting the custom battery to the transmitter shell include various techniques such as using double sided tape, adhesive, etc. to keep them in place or from shifting around.

Referring toFIG. 66A, a partial plane view of a transmitter assembly layout is illustrated according to an embodiment of the present disclosure. As described above according to one or more embodiments, a shell subassembly of atransmitter assembly6606 includes aPCB6618 disposed on a portion, for example, substantially one half portion, and acustom battery6614 disposed on another portion, for example, substantially the other remaining half portion of the shell subassembly oftransmitter assembly6606.

FIG. 66B illustrates another partial plane view of a transmitter assembly according to an embodiment of the present disclosure.

Elastomeric connectors

6632aand6632bare connected to aPCB6618. In this embodiment,elastomeric connector6632ais adapted to accommodate fourcontacts6628aandelastomeric connector6632bis adapted to accommodate sixcontacts6628b. It should be noted that in various embodiments the elastomeric connectors are adapted to accommodate different numbers of contacts as necessary for particular applications.

FIG. 66C is a perspective partial view of a transmitter assembly layout illustrating details of external contacts to a PCB according to another embodiment of the present disclosure. As described above according to an embodiment,transmitter assembly6606 includes aPCB6618 disposed on substantially one half portion and acustom battery6614 disposed on substantially the other half portion oftransmitter assembly6606. As illustrated inFIG. 66D, detail “A”, a first side, e.g., a top side, of anelastomeric connector6632 attaches to or otherwise connects with aPCB contact pad6635.External contacts6628 are disposed on or are otherwise connected to another side ofelastomeric connector6632, which includes conductive material.

FIG. 67 illustrates perspective side views for electrically connecting a sensor assembly to a transmitter assembly according to an alternative embodiment.

Asensor transmitter assembly6700 includes atransmitter assembly6706 placed on a top surface of asensor assembly6712 by initially positioning, for example lowering downtransmitter assembly6706 intosensor assembly6712. At this stage, anelastomeric connector6732 and acontact6728 oftransmitter assembly6706 are not aligned with anelastomeric connector6702 of sensor assembly6712 (see detail “B”). A twisting or rotation motion while squeezing onareas6742aand6742b, as indicated by arrow “A”, is used to locktransmitter assembly6706 andsensor assembly6712.

Indicators

6752,6754 and6756 indicate the locking position ofsensor transmitter assembly6700. For example, whenindicator6752 is aligned withindicator6754, the sensor transmitter assembly is in an unlocked position, and whenindicator6752 is aligned withindicator6756, the sensor transmitter assembly is in a locked position. As a result of the rotation motion, as illustrated in detail “C”,elastomeric connector6732 andcontact6728 oftransmitter assembly6706 line up withelastomeric connector6702 ofsensor assembly6712, thus completing the connection.

Referring toFIG. 68, a partial top view of an electrical connection of a sensor assembly and at least one contact of a transmitter assembly is illustrated according to an alternative embodiment of the present disclosure. As described above according to one or more embodiments, asensor assembly6512 includes a sensor base having a cavity in which anelastomeric connector6532 is disposed. When a transmitter assembly is connected to the sensor assembly, at least one contact of the transmitter assembly makes a connection with theelastomeric connector6532. In this embodiment, sixcontacts6528 of a transmitter assembly connect withelastomeric connector6532. In some cases angular misalignment may occur between the contacts. In this embodiment, an angular misalignment of approximately 5° is shown between the contacts. Even thoughcontacts6528 do not line straight up, they still make electrical contact withelastomeric connector6532. As such, in various embodiments, a tolerance of up to about 5° angular misalignment can occur without disrupting the connection between the contacts and the elastomeric connector and otherwise running into another area. Advantageously, the angular misalignment is within a margin of error such that even if the contacts are angularly misaligned, the design of the elastomeric connector ensures that an electrical connection is robust. If a transmitter assembly is mechanically connected tosensor assembly6512, then an electrical connection is ensured.

Sensor Connections—Alternative Embodiments

Alternative Embodiment 1—Rigid Flex Connector

Referring toFIGS. 69A-69B, exploded views of a sensor module having a back to back sensor connection with a rigid flex connector are illustrated according to alternative embodiments of the present disclosure.FIG. 69A is an exploded top view of the sensor module having a back to back sensor connection with a rigid flex connector according to an alternative embodiment of the present disclosure, andFIG. 69B is an exploded bottom view of the sensor module ofFIG. 69A according to an alternative embodiment of the present disclosure.

As illustrated inFIG. 69A andFIG. 69B, asensor module6901 includes a first sensor, e.g., anupper sensor6940, a second sensor, e.g., alower sensor6944 and aflex circuit6948. As illustrated inFIG. 69A,upper sensor6940 includes a sensor head having at least one uppersensor contact pad6935. In this embodiment, three uppersensor contact pads6935 are illustrated. Also, threewindows6959 on the sensor head are illustrated.Upper sensor6940 also includes at least oneelectrode6938a(e.g., threeelectrodes6938aas illustrated inFIG. 69A) on aleg6936aextending from the upper sensor head. As illustrated in the exploded bottom view ofFIG. 69B,lower sensor6944 includes at least one lowersensor contact pad6939. In this embodiment, three lowersensor contact pads6939 are illustrated.Lower sensor6944 also includes aleg6936bhaving at least oneelectrode6938bextending from the lower sensor head. It should be noted thatupper sensor6940 andlower sensor6944 can have any number of contact pads in any appropriate placement, as well as windows and electrodes as appropriate for an application. Also, the upper and lower sensors may be alternatively positioned on a bottom or a top as part of the sensor module.Flex circuit6948 will be described in more detail below for example with respect to the embodiment ofFIGS. 71A-71B.

FIGS. 70A-70B illustrate perspective views of a sensor module having a back to back sensor connection with a rigid flex connector according to alternative embodiments of the present disclosure.FIG. 70A is a perspective top view of the sensor module having a back to back sensor connection with a rigid flex connector according to an alternative embodiment of the present disclosure.FIG. 70B is a perspective bottom view of the sensor module ofFIG. 70A according to an alternative embodiment of the present disclosure.

Sensor module

6901 is formed by assembling a first sensor such as an upper sensor6940 (illustrated inFIGS. 69A-69B) and a second sensor such as a lower sensor6944 (illustrated inFIGS. 69A-69B) to arigid flex circuit6948. Assembly of the sensor module will be described in more detail below for example with respect to the embodiments ofFIGS. 72A-72D.

Sensor module

6901 is assembled together before installation into a base, for example, asensor base6019 as illustrated in the embodiment ofFIG. 60A. Advantageously, by assembling the sensor module before installation into a base, the sensor contact pads and sensor legs easily line up with each other, and it becomes possible to insert both sensor legs into the base at once, which is easier than inserting the sensor legs one at a time.

FIG. 71A is a perspective bottom view of a flex circuit according to an embodiment of the present disclosure.FIG. 71B is a perspective top view of the flex circuit ofFIG. 71A according to an embodiment of the present disclosure.

Aflex circuit7148 includes at least one conducting pad on a first surface. In this embodiment, a top surface offlex circuit7148 includes sixconducting pads7154 that are isolated from each other (illustrated inFIG. 71B). Conductingpads7154 are adapted to conduct a signal from lower sensor contact pads to at least one elastomeric connector. Abottom surface7152aand atop surface7152bofflex circuit7148 include fastening techniques such as double-sided adhesive on the top surface and the bottom surface respectively. Double-sided adhesive, for example, can bond the upper and lower sensors to the top side of the flex circuit, and the bottom side of the flex circuit to a base such as a sensor base. It should be noted that other types of fastening techniques such as solder, staples, etc. can be used to bond sensors to a first side of the flex circuit and bond a second side of the flex circuit to a base. Also, the flex circuit can be of any appropriate type, material or shape that fits into a base and accommodates appropriate sensors on a surface as needed for various applications. In various embodiments, the flex circuit construction includes a polyimide base layer, Copper conducting pads, and a polyimide cover layer, where the layers are bonded by appropriate bonding techniques such as with adhesive. In one or more embodiments, the flex circuit includes a single layer of conductor laminated to polyimide with circuitry or traces accessible from one side, and single-sided flex can be manufactured with or without coverlayers, which can act as a protective barrier or dielectric and are usually on a first or “top” side of the flex, depending on the intended application or requirement.

FIGS. 72A-72D illustrate an assembly process for a sensor module according to an embodiment of the present disclosure.

First, a lower sensor is assembled with a flex connector (also referred to as “flex circuit”). As illustrated inFIG. 72A, alower sensor7244 is positioned or rotated, for example as indicated by arrow “A” on aflex circuit7248. Lowersensor contacts pads7239 are positioned so that they are in contact with flexcircuit contact pads7254.Windows7259 oflower sensor7244 expose the flexconnector contact pads7254.

InFIG. 72B,tabs7256 oflower sensor7244 adhere or are otherwise fastened to flexcircuit areas7252, which include fastening techniques such as an adhesive. Notably,tabs7256 are smaller than or fit within thesurface area7252 of the flex circuit having, for example, an adhesive. In this way, a portion offlex circuit areas7252 having fastening techniques such as an adhesive are left exposed to allow bonding of an upper sensor.

Second, an upper sensor is assembled with the flex connector. As illustrated inFIG. 72C, anupper sensor7240 is positioned or rotated, for example, as indicated by arrow “B” on the combination of alower sensor7244 and a flex connector as illustrated in the embodiment ofFIG. 72B.Upper sensor7240 includestabs7262 and at least onewindow7269. Theseupper sensor tabs7262 bond to a remaining portion offlex circuit areas7252 having fastening techniques such as a double-sided adhesive (or other fastening techniques) on the flex connector.Windows7269 ofupper sensor7240 align withwindows7259 oflower sensor7244.

As illustrated inFIG. 72D, as a result ofwindows7269 ofupper sensor7240 aligning withwindows7259 oflower sensor7244, flexconnector contact pads7254 are left exposed.

Referring now toFIGS. 73A-73B, a sensor module installed in a sensor subassembly is illustrated according to an alternative embodiment of the present disclosure.

InFIG. 73A, asensor subassembly7312 includes asensor base7319 having a recess or cavity in which asensor module7301 is installed. In various embodiments,sensor module7301 has components as illustrated, for example, in the embodiments ofFIGS. 69A-69B and 70A-70B. InFIG. 73B, a connector such as a z-axis elastomeric connector7302 is installed on top of the sensor module.

As described above according to one or more embodiments,sensor base7319 also includes at least one compression area or snap arm, for example, in this embodiment, two

compression areas

142aand142bor snap arms are located on either side ofsensor base7319. Also as described above,

compression areas

142aand142bor snap arms are designed to be self-locking. That is, if a user tries to disconnect a transmitter subassembly (not shown) fromsensor subassembly7312 just by rotating it and without manually squeezing

compression areas

142aand142bor snap arms inwards, then the rotation causes the

compression areas

142aand142bor snap arms to flex outwards and lock even harder against the transmitter subassembly. If the

compression areas

142aand142bor snap arms were not self-locking, then it would be possible to rotate the transmitter subassembly hard enough to unlock the

compression areas

142aand142bor snap arms, which would defeat a double fail-safe feature as described above, for example, with respect to the embodiments ofFIGS. 56A and 56B.

Referring now toFIG. 74, a signal path to a transmitter from a lower sensor is illustrated according to an embodiment of the present disclosure.

Atransmitter assembly7406 is connected to asensor assembly7412. As a result, at least a portion of a bottom surface oftransmitter assembly7406 compresses a connector, e.g., a z-axis elastomeric connector7402 against asensor module7401.

As shown in details “A” and “B”,elastomeric connector7402 compresseslower sensor pads7439 against flexcircuit contact pads7448.Elastomeric connector7402 extrudes throughwindows7452 in thesensor module7401 and contacts the flex circuit contact pads. As a result, a signal path is created between the contact pads of the lower sensor ofsensor module7401 andtransmitter contacts7424.

FIG. 75 illustrates a signal path to a transmitter from an upper sensor according to an embodiment of the present disclosure.

As a result of atransmitter assembly7506 being connected to asensor assembly7512, a connector, e.g., a z-axis elastomeric connector7502, is compressed against asensor module7501 as shown in details “A” and “B”. A signal from an uppersensor contact pad7535 travels directly throughelastomeric connector7502 totransmitter contacts7524.

Alternative Embodiment 2—Flex Connector Integrated With Lower Sensor

FIG. 76 illustrates a perspective view of a lower sensor with conducting pads and an integrated flex connector according to an embodiment of the present disclosure. A first sensor, e.g., alower sensor7644 is similar tolower sensor6944 described above with respect to the embodiment ofFIG. 69A-69B, except that conductingpads7654 are integrated into a portion of an area such as on a side oflower sensor6944 that extends from the lower sensor head. As such,lower sensor7644 includes at least one lowersensor contact pad7639. In this embodiment, three lowersensor contact pads7639 are illustrated.Lower sensor7644 also includes aleg7638 extending from the lower sensor head. In one or more embodiments, at least oneelectrode7638a, for example threeelectrodes7638aas illustrated in this embodiment ofFIG. 76, are placed on the extension orleg7638. In various embodiments,lower sensor7644 is foldable or otherwise flexible along aline7616 that divides a head of the lower sensor into a portion or side where conductingpads7654 are located. In various embodiments,line7616 includes notches, perforations, or other techniques to facilitate folding or bending alongline7616. In various embodiments, perforations, notches, or the like can be made alongline7616 with laser techniques.

FIGS. 77A-77D illustrate perspective views for assembling the lower sensor ofFIG. 76 according to an embodiment of the present disclosure. In the embodiment ofFIG. 77A,lower sensor7644 is illustrated having integrated conductingpads7654 on a distal portion of a sensor head andcontact pads7639 on a proximate portion of the sensor head. As shown inFIG. 77B,lower sensor7644 is assembled by first folding a portion of the sensor head as indicated by arrow “A”. In that regard, the head oflower sensor7644 is folded along an appropriate folding line such thatconducting pads7654 are placed in contact withlower sensor pads7639. For example,lower sensor7644 is folded at about a halfway point such that the conducting pads are placed in contact with the lower sensor contact pads.FIG. 77C illustrates a first surface after the lower sensor is folded. The first surface, for example, a bottom surface of the folded lower sensor can be flipped around as indicated by arrow “B”.FIG. 77D illustrates a second surface of the folded lower sensor. The second surface, for example, a top surface of the folded lower sensor includes windows through whichconducting pads7654 are exposed.

FIG. 78 illustrates a signal path to a transmitter from the lower sensor having an integrated flex connector illustrated inFIGS. 76 and 77A-D according to an embodiment of the present disclosure.

A signal path for thelower sensor7644 is similar to the signal path illustrated in the embodiment ofFIG. 74, except that in this embodiment a conducting pad is part of thelower sensor7644 itself instead of a separate flex connector. As a result of a transmitter assembly being connected to a sensor assembly, at least a portion of a bottom surface of the transmitter assembly compresses a connector, e.g., a z-axis elastomeric connector, against a sensor module. The elastomeric connector compresses the lower sensor contact pads and the conducting pads7654 (seeFIG. 77B-77D). The elastomeric connector extrudes through windows in the sensor module andcontacts conducting pads7654. As a result, a signal path is created between the conducting pads of the lower sensor and corresponding transmitter contacts.

Alternative Embodiment 3—Flex Connector Integrated With Sensor, Sensors Interlaced

FIGS. 79A-79B illustrate exploded views of a sensor module having conducting pads integrated into a sensor according to an alternative embodiment of the present disclosure.FIG. 79A is a top exploded view of the sensor module having conducting pads integrated into a sensor according to an alternative embodiment of the present disclosure.FIG. 79B is a bottom exploded view of the sensor module ofFIG. 79A according to an alternative embodiment of the present disclosure.

As illustrated inFIG. 79A andFIG. 79B, a sensor module includes afirst sensor7940 and asecond sensor7944. As illustrated inFIG. 79A,first sensor7940 includes a sensor head having at least onesensor contact pad7935 and at least oneconducting pad7954 integrated on the first sensor itself, for example on a portion of the first sensor head such as a portion extending from the first sensor head. In this embodiment, threesensor contact pads7935 and threeconducting pads7954 are illustrated.First sensor7940 also includes aleg7936 extending from the first sensor head having at least onefirst sensor electrode7937. In this embodiment threefirst sensor electrodes7937 are illustrated. As shown inFIG. 79B, asecond sensor7944 includes at least one secondsensor contact pad7939. In this embodiment, three secondsensor contact pads7939 are illustrated.Second sensor7944 also includes aleg7938 extending from the second sensor head having at least onesecond sensor electrode7941. In this embodiment, threesecond sensor electrodes7941 are illustrated.

FIGS. 80A-80B are perspective views illustrating sensor interlacing of the first and second sensors illustrated inFIGS. 79A-B according to an alternative embodiment of the present disclosure.FIG. 80A is a top perspective view illustrating a sensor module with sensor interlacing of the first and second sensors according to an embodiment of the present disclosure.FIG. 80B is a bottom perspective view of the sensor module ofFIG. 80A according to an embodiment of the present disclosure.

Sensor module

7901 is formed by interlacing afirst sensor7940 and a second sensor7944 (illustrated inFIGS. 79A-B). As illustrated inFIGS. 80A-80B, the first sensor and the second sensor are interlaced such that adistal end8022 offirst sensor7940 is placed on top of adistal end8026 ofsecond sensor7944, but ahead8028 offirst sensor7940 is placed on the bottom or underneathhead8024 ofsecond sensor7944. Such interlacing of the first and second sensors places the second sensor's contact pads7939 (shown inFIG. 79B) against the first sensor'sconducting pads7954. Windows on thesecond sensor head8024

expose contact pads

7935 and conductingpads7954 offirst sensor7940.

FIG. 81 illustrates a signal path to a transmitter from a first sensor having an integrated flex connector that is interlaced with a second sensor as illustrated inFIGS. 80A-80B according to an embodiment of the present disclosure.

As a result of a transmitter assembly being connected to a sensor assembly, at least a portion of a bottom surface of the transmitter assembly compresses a connector, e.g., a z-axis elastomeric connector, against a sensor module. Anelastomeric connector8102 compresses thefirst sensor pads7935. The elastomeric connector extrudes through at least one window in the sensor module and contactsfirst sensor pads7935. As a result, a signal path is created from acontact pad7935 of the first sensor directly through theelastomeric connector8102 to the transmitter contacts (as indicated by arrow “A”).

FIG. 82 illustrates a signal path to a transmitter from a second sensor that is interlaced with a first sensor as illustrated inFIGS. 80A-80B according to an embodiment of the present disclosure.

As a result of a transmitter assembly being connected to a sensor assembly, at least a portion of a bottom surface of the transmitter assembly compresses a connector, e.g., a z-axis elastomeric connector, against a sensor module. In this case, a signal from a lowersensor contact pad7939 travels through aconducting pad7954 of a first sensor and through anelastomeric connector8102 to a corresponding transmitter contact.

Combined Sensor and Infusion Set

FIGS. 83A-83E are orthogonal views of a combined sensor and infusion set according to an embodiment of the present disclosure.FIG. 83A is a top orthogonal view,FIG. 83B is a front orthogonal view,FIG. 83C is a side orthogonal view,FIG. 83D is a back orthogonal view, andFIG. 83E is a bottom orthogonal view of a combined sensor and infusion set according to an embodiment of the present disclosure.

FIGS. 84A-84C are isometric views of the combined sensor and infusion set ofFIGS. 83A-83E according to an embodiment of the present disclosure.FIG. 84A is an isometric perspective front view,FIG. 84B is an isometric perspective back view andFIG. 84C is an isometric perspective bottom view of the combined sensor and infusion set according to an embodiment of the present disclosure.

Asensor transmitter assembly8300, for example, as described above with respect to at leastFIGS. 1A, 1B, 41A-41C and 56A-56B according to various embodiments, is combined with aninfusion set8350.Infusion set8350 is coupled to an area or portion such as a side ofsensor transmitter assembly8300 as will be described in more detail below, for example, with respect to the embodiments ofFIGS. 86A-86E.

As illustrated for example at least inFIGS. 83B, 84A and 84B, and as described above according to one or more embodiments,sensor transmitter assembly8300 includes atransmitter assembly8306 placed on top of asensor assembly8312. Asensor portion8304 extends fromsensor assembly8312 from a substantially centered location. Thesensor assembly8312 provides structural support tosensor portion8304 and facilitates entry ofsensor portion8304 into the body of a patient. As such, in various embodiments,sensor portion8304 may be positioned subcutaneously/transcutaneously in direct contact with a patient's extracellular fluid. As illustrated for example inFIGS. 83C, 83D and 84C, acannula8354 extends frominfusion set8350.Cannula8354 is also adapted to be introduced into the body of a patient for infusing fluids such as insulin or other medications to a patient.Infusion set8350 includes aninsertion conduit8352 adapted to be connected to a reservoir or other supply device.

The combined sensor and infusion set can be fastened by a mounting base orpatch8302 that adheres to the patient's skin, as described above for example at least in connection with the embodiments ofFIGS. 1A, 1B, 2A, 2B, 57A and 57B.

Referring toFIG. 85, section views of a combined sensor and infusion set are illustrated according to an embodiment of the present disclosure.

Asensor transmitter assembly8500 is combined with aninfusion set8550.Sensor transmitter assembly8500 includes components similar to embodiments described above, for example at least in connection withFIGS. 11A-11C, 66A-67.

As illustrated in detail “A”, infusion set8550 includes a housing8562, aseptum8564, afunnel8566 and acannula8568. Housing8562 engages with a connection portion8572 that extends from the sensor assembly as will be described in more detail below. In various embodiments,septum8564 is compressed betweenfunnel8566 and the connection portion8572. When housing8562 is connected,septum8564 forms a radial seal around a needle (not shown) contained in housing8562, creating a sealed fluid path between tubing of housing8562 andcannula8568.Funnel8566 compressescannula8568 against connection portion8572. This mechanically retainscannula8568 within connection portion8572 and creates a fluid tight seal betweenfunnel8566,cannula8568, and connection portion8572.

FIGS. 86A-86B illustrate a connection for a sensor and infusion set according to an embodiment of the present disclosure.

FIG. 86A illustrates a disconnected sensor and infusion set according to an embodiment.Sensor transmitter assembly8600 includes aconnector portion8672 that extends from a portion, for example, a base of asensor assembly8612.Connection portion8672 includes aconnector cap8674 adapted to fittingly receive aninfusion set8650. A top down connection is applied as indicated by arrow “A” to connectsensor transmitter assembly8600 toinfusion set8650.

FIG. 86B illustrates a perspective front view showing

front surfaces

8662aand8662bof infusion set8650 that are adapted to fit on or against a surface ofsensor transmitter assembly8600.FIG. 86C illustrates a perspective back view showing a back surface ofinfusion set8650. In an embodiment, infusion set8650 engages, e.g., snaps mechanically withconnection portion8672. For example, infusion set8650 engages at one or more interfaces such as notches or points “a” and “b” ofconnection portion8672, andcannula8568, which extends out, is adapted to fit and engage with aconnector cap8674 ofconnection portion8672.FIG. 86D shows a combined sensor infusion set8610 as a result of a top down connection, andFIG. 86E shows a detail of a back surface view of infusion set8650 being connected toconnection portion8672.

Advantageously, the combined sensor infusion set for example as illustrated inFIG. 86D has a small footprint and is smaller in size than prior devices. A combined sensor infusion set according to one or more embodiments can have dimensions as follows: Height=0.32 inches; Width=1.16 inches; Length=1.41 inches; Footprint=1.14 square inches; and Volume=0.32 cubic inches. Table 3 below illustrates reduction in overall size of the combined sensor infusion set according to one or more embodiments of the present disclosure compared to a prior device.

TABLE 3

	New Duo or Device
Previous Device	According to one or
or Duo	more Embodiments	% Reduction

Height (in)	0.37	0.32	13.5%
Width (in)	1.40	1.16	17.1%
Length (in)	2.11	1.41	33.2%
Footprint (in²)	1.91	1.14	40.3%
Volume (in³)	0.43	0.32	25.6%

Disposable Insertion Tool Piercing Member Protection Mechanism

As described above with respect toFIGS. 45A-55 according to one or more embodiments, a disposable insertion tool or device includes various components including a plunger, a striker, a sensor assembly, a needle carrier and a piercing member (e.g. needle), etc. such that a sensor is caused to be inserted at an insertion site on the body of a user where the sensor remains fastened to the user's body via a mounting base. With the sensor assembly adhered to the user's body, the sensor assembly is released from the insertion device in response to the user pulling away the insertion device. The piercing member is retracted such that it is encapsulated well inside the insertion device (see, e.g.,FIGS. 53B, 54).

One way to protect the retracted piercing member once the insertion device has been used is to make the plunger long or tall enough so that the piercing member retracts sufficiently far into the insertion device so that it cannot be exposed again even if the user depresses both the plunger and the striker of the insertion device. However, this way would add considerable volume and height to the insertion device, which could be undesirable to the user.

Referring toFIG. 87A, a used insertion device is illustrated according to an embodiment of the present disclosure. Similar to one or more embodiments described above, a used insertion device ortool8700 includes aneedle carrier8746 in a retracted position. In this regard, aneedle carrier spring8744 expands and retractsneedle carrier8746 such that piercingmember8710 is encapsulated well inside usedinsertion tool8700.

FIG. 87B illustrates the used insertion tool ofFIG. 87A with a depressed plunger and striker according to an embodiment. In some instances, afterinsertion tool8700 has been used, a user may attempt to depressplunger8702, accidentally or intentionally for example as indicated by downward arrow “A”, andstriker8736 as indicated by arrow “B”. As a result, atip8737 of piercingmember8710 is exposed.

Once the insertion tool or device has been used, that is, released and pulled away from the user's body, a disposable insertion tool piercing member protection mechanism alleviates potential exposure of the tip of the piercing member (e.g., needle). The piercing member remains protected inside the insertion device even if the user attempts to depress the plunger and striker on the used insertion device. According to one or more embodiments, the piercing member (e.g., needle) is prevented from being exposed by preventing the plunger and striker of the insertion device or tool from being fully depressed again once the insertion tool has been used. Advantageously, the user is protected from accidental needle sticks.

Referring toFIG. 88, a cutout section view of an insertion tool having a piercing member protection mechanism is illustrated according to an embodiment of the present disclosure.Insertion tool8800 includes various components including a needle carrier8846 (which will be described in more detail below with respect to the embodiment ofFIG. 89), a striker8836 (which will be described in more detail below with respect to the embodiment ofFIG. 90), a plunger8802 (which will be described in more detail below with respect to the embodiment ofFIG. 91), and a piercing member8810 (e.g., a needle). Onceinsertion tool8800 has been used, for example, after it has been pulled away after inserting a sensor into the body of a user,plunger8802 andstriker8836 are prevented from being fully depressed again (for example as indicated by arrows “A” and “B”) as will be described in more detail below. As a result, atip8837 of piercingmember8810 is protected from exposure without adding excessive volume toinsertion tool8800.

FIG. 89A illustrates a section view of an insertion device having a piercing member protection mechanism including a needle carrier disposed therein according to an embodiment of the present disclosure.FIG. 89B illustrates a perspective view of the needle carrier ofFIG. 89A according to an embodiment of the present disclosure.FIG. 89C illustrates a top view of the needle carrier ofFIGS. 89A and 89C according to an embodiment of the present disclosure.

As described above according to one or more embodiments and as illustrated inFIG. 89A, aneedle carrier8846 is disposed inside or within an interior volume of an insertion device ortool8900 along with a needle carrier tension mechanism orspring8944. As illustrated in the embodiment ofFIGS. 89B and 89C,needle carrier8846 includes at least onecam rail8954 disposed on or extending along an inner wall or surface ofneedle carrier8846. In this embodiment, twocam rails8954 are illustrated and are disposed on opposite sides along an inner surface ofneedle carrier8846.Needle carrier8846 also includes at least oneouter guide rail8955 disposed on or extending along an outer wall or surface ofneedle carrier8846. In this embodiment, twoguide rails8955 are illustrated and are disposed on opposite sides along an outer surface ofneedle carrier8846. It should be noted that in this embodiment,needle carrier8846 has a substantially tube or pipe-like shape with a circular cross-section, however,needle carrier8846 can be of any appropriate shape or have any appropriate cross-section such as rectangular, oval, square, etc.

FIG. 90A illustrates a section view of an insertion device having a piercing member protection mechanism including a striker disposed therein according to an embodiment of the present disclosure.FIG. 90B illustrates a perspective view of the striker ofFIG. 90A according to an embodiment of the present disclosure.FIG. 90C illustrates a top view of the striker ofFIGS. 90A and 90B according to an embodiment of the present disclosure.

As described above according to one or more embodiments and as illustrated inFIG. 90A, astriker8836 is disposed inside or within an interior volume of an insertion device ortool8900. As illustrated in the embodiment ofFIGS. 90B and 90C,striker8836 includes at least oneguide slot9057 disposed on or extending along an outline of an inner wall. In this embodiment, twoguide slots9057 are illustrated and are disposed on opposite sides along an outline of an inner surface or wall ofstriker8836.

FIG. 91A illustrates a section view of an insertion device having a piercing member protection mechanism including a plunger according to an embodiment of the present disclosure.FIG. 91B illustrates a perspective view of the plunger ofFIG. 90A according to an embodiment of the present disclosure.FIG. 91C illustrates a section view cutout along line A-A′ of the striker ofFIG. 91B according to an embodiment of the present disclosure.

As described above according to one or more embodiments and as illustrated inFIG. 91A,insertion tool8900 includes aplunger8802. The embodiment ofFIG. 91B illustrates an outer surface or shape ofplunger8802.FIG. 91C illustrates a section view of an inside ofplunger8802, which includes a shaft9159 substantially centered or extending from a top surface ofplunger8802. Shaft9159 has a cammed surface that includes at least one locking slot9157 from a first end proximate to the top surface ofplunger8802 and extending along a wall or surface of shaft9159 into a cam9158. It should be noted that a similar configuration for a locking slot and a cam is disposed on an opposite side of shaft9159 (not shown).

FIGS. 92A and 92B illustrate an insertion sequence for an insertion tool having a piercing member protection mechanism according to an embodiment of the present disclosure. In that regard,FIG. 92A illustrates a section view of an insertion tool that has not been used or fired.FIG. 92B illustrates a section view of the insertion tool during insertion.FIG. 92C illustrates a top section view of a needle carrier and a striker of the insertion tool ofFIG. 92B during insertion according to an embodiment of the present disclosure.

InFIG. 92A, aninsertion tool9200 is in an unused state, that is, before it has been fired or before it has been used to, for example, insert a sensor into a user's body. As described above according to one or more embodiments,insertion tool9200 includes various components such as aneedle carrier9246, astriker9236, aplunger9202 and a piercing member9210 (e.g., needle).FIG. 92B illustratesinsertion tool9200 during insertion, for example, being used or fired. In that regard,needle carrier9246 andstriker9236 have been depressed so that the insertion tool is fired, for example, in response to a user pressing onplunger9202 so that piercingmember9210 is inserted into the body of the user. As illustrated inFIG. 92C, during insertion,guide rails9255 ofneedle carrier9246 fit insideguide slots9257 ofstriker9236. It should be noted thatneedle carrier9246 andstriker9236 can have interfaces such asguide rails9255 and guideslots9257 that are sized and/or shaped in any appropriate manner to engage, match or fit each other.

FIG. 93A is a section view illustrating a first half of a retraction of a needle carrier of an insertion tool having a piercing member protection mechanism according to an embodiment of the present disclosure.FIG. 93B illustrates a top section view of a needle carrier and a striker of the insertion tool ofFIG. 93A during retraction according to an embodiment of the present disclosure.

As described above according to one or more embodiments, a user can useinsertion tool9200 to insert a sensor into the body of the user. After insertion, the user releasesplunger9202. Releasingplunger9202 actuates a needle retraction mechanism including aspring9244. The needle retractionmechanism including spring9244 retractsneedle carrier9246 back into an interior volume ofinsertion tool9200 as indicated by arrow “A”. During approximately the first half of the retraction,needle carrier9246 is guided byguide slots9257 ofstriker9236. As illustrated inFIG. 93B,guide rails9255 ofneedle carrier9246 fit insideguide slots9257 ofstriker9236.

FIGS. 94A-94C-1 illustrate section views of a sequence of rotation of a needle carrier of an insertion tool having a piercing member protection mechanism as the needle carrier continues to retract into the insertion tool according to one or more embodiments.

As described above with respect to the embodiments ofFIGS. 93A-93B, a needle carrier is guided by one or more guide slots of a striker during the first half of the retraction of the needle carrier into the insertion tool.FIG. 94A illustrates a section view of aneedle carrier9246 retracted about halfway into a top portion ofinsertion tool9200 surrounded or encapsulated byplunger9202. In this instance, a top ofneedle carrier9246 is approximately halfway intoplunger9202 as generally indicated by area G1. Asneedle carrier9246 continues to retract, it pulls free fromstriker9236 and instead of being guided by the guide slots ofstriker9236,needle carrier9246 becomes guided by acammed surface9459 ofplunger9202 as illustrated in detail “A”.FIG. 94A-1 illustrates a top view of the needle carrier retracted about halfway into a top portion of the insertion tool that includes the plunger. Cam rails9254 ofneedle carrier9246 contact angledcams9258 ofstriker9202.

FIG. 94B illustrates a section view of aneedle carrier9246 substantially in mid rotation within the insertion tool according to an embodiment of the present disclosure.FIG. 94B-1 is a top section view of the needle carrier substantially in mid rotation. Aftercam rails9254 ofneedle carrier9246 contact angledcams9258 ofplunger9202 as described above according to an embodiment,needle carrier9246 rotates in a certain direction as guided byangled cams9258 as illustrated in detail “B”. In this instance, a top ofneedle carrier9246 is such that cam rails9254 contact angledcams9258 at an area generally as indicated by “G2”.Needle carrier9246 rotates guided by an angle corresponding to the angle ofangled cams9258, for example, by approximately 60 degrees. It should be noted thatangled cams9258 can be of any appropriate angle for a particular use or design, for example, 50 degrees, 75 degrees, etc., to guide and rotate cam rails9256 as appropriate. In an example,needle carrier9246 rotates in a counterclockwise direction as indicated by arrow “C” inFIG. 94B or arrow “D” inFIG. 94B-1.

FIG. 94C is a section view of a needle carrier fully retracted and rotated within the insertion tool according to an embodiment of the present disclosure.FIG. 94C-1 is a top view of the needle carrier fully retracted and rotated. As described above,needle carrier9246 is rotated by a certain angle, for example approximately 60 degrees, as guided by one or more angled cams ofplunger9202.Needle carrier9246 fully rotates as indicated by arrow “F” inFIG. 94C (or arrow “H” inFIG. 94C-1), for example, in a counterclockwise direction, and fully retracts as indicated by arrow “E” intoinsertion tool9200. In this instance, for example, a top surface ofneedle carrier9246 is proximate to an inner portion of a top surface ofplunger9202 as generally indicated as area “G3”. As illustrated inFIG. 94C-1,cam rails9254 of needle carrier9256 are rotated and fully retracted intocorresponding locking slots9257 ofplunger9202. As described above for example with respect to the embodiment ofFIG. 91C, lockingslots9257 are located on a shaft portion ofplunger9202 and extend into the angled cams ofplunger9202. As such, according to one or more embodiments, lockingslots9257 ofplunger9202 engagecam rails9254 ofneedle carrier9246, permanently locking the retractedneedle carrier9246 in the rotated position. Also,spring9244 ofneedle carrier9246 holds the fully retractedneedle carrier9246 againstplunger9202.

FIGS. 95A-95C illustrate section views of a locking or piercing member protection mechanism for an insertion tool according to one or more embodiments of the present disclosure.

As illustrated inFIG. 95A when aneedle carrier9246 is locked in a rotated position as described above according to one or more embodiments,guide rails9255 ofneedle carrier9246 do not line up withguide slots9257 ofstriker9236. As illustrated in detail “A”, for example, an end “m” of aguide rail9255 no longer lines up withstriker guide slot9257.FIG. 95B illustrates a top section view of the insertion tool before insertion according to an embodiment, andFIG. 95C illustrates a top section view of the insertion tool after insertion according to an embodiment of the present disclosure. InFIG. 95B, beforeinsertion tool9200 is used or fired, for example, before the insertion tool is used by a user to insert a sensor into the user's body,guide rails9255 ofneedle carrier9246 line up withguide slots9257 ofstriker9236. InFIG. 95C, afterinsertion tool9200 is used or fired andneedle carrier9246 is retracted and locked in a rotated position as described above,guide rails9255 ofneedle carrier9246 no longer line up withguide slots9257 ofstriker9236.

FIG. 96 illustrates a section view of a used or fired inserter tool having a locking or piercing member protection mechanism with a plunger and striker depressed according to an embodiment of the present disclosure. As described above according to one or more embodiments, afterinsertion tool9200 has been used or fired, for example, to insert a sensor into the body of a user, aneedle carrier9246 is fully retracted and rotated into the insertion tool. At this state, as illustrated in the embodiment ofFIG. 96, if the user attempts to depressplunger9202, for example as indicated by arrow “A”, andstriker9236, for example as indicated by arrow “B”, the guide rails onneedle carrier9246 interfere with at least a portion of a top surface ofstriker9236, for example, as indicated at points “p” and “p1”. In this regard,needle carrier9246 acts as a barrier or wedge betweenplunger9202 andstriker9236, thus preventingplunger9202 andstriker9236 from being fully depressed. Advantageously, becauseplunger9202 andstriker9236 cannot be fully depressed,needle tip9237 remains protected withininsertion tool9200 at all times.

While the description above refers to particular embodiments of the present disclosure, it will be understood that many modifications may be made without departing from the spirit thereof. The accompanying claims are intended to cover such modifications as would fall within the true scope and spirit of the present disclosure.

The presently disclosed embodiments are therefore to be considered in all respects as illustrative and not restrictive, the scope of the present disclosure being indicated by the appended claims, rather than the foregoing description, and all changes which come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein.