FIELD

Embodiments of the subject matter described herein relate generally to medical devices, such as a physiological characteristic sensor assembly. More particularly, embodiments of the subject matter relate to a flexible physiological characteristic sensor assembly for coupling to a user having at least one physiological characteristic sensor that observes a physiological characteristic of the user. In various embodiments, the physiological characteristic sensor is a glucose sensor.

BACKGROUND

Sensors may be employed in the treatment of or monitoring of various medical conditions. In one example, electrochemical sensors are used to test analyte levels in patients or users. More specifically, sensors have been designed for use in obtaining an indication of blood glucose (BG) levels and monitoring BG levels in a diabetic user, with the distal segment portion of the sensor positioned subcutaneously in direct contact with extracellular fluid. Such readings can be especially useful in adjusting a treatment regimen which typically includes regular administration of insulin to the user.

Generally, sensors for monitoring BG levels are coupled to the body of the user over a period of time. In most instances, the sensors for monitoring BG levels are coupled to a continuous glucose monitor (CGM), which has associated electronics that process the sensor signals, monitor BG levels and may transmit the BG levels to a remote device, such as an infusion device. The housing of the CGM is a rigid structure. The rigid nature of the housing for the CGM may tend to transfer moment forces from one end of the device to the other, which may lead to a peeling of an adhesive that couples the sensor for monitoring BG levels and the CGM to the body, or may lead to a partial removal of the distal segment portion of the sensor from the subcutaneous tissue, both of which may impact the sensor readings. Moreover, the rigid nature of the CGM may be uncomfortable to the user, as the rigid nature of the CGM does not enable the CGM to conform to the user's anatomy.

Accordingly, it is desirable to provide a physiological characteristic sensor assembly, such as a blood glucose sensor, that is flexible to reduce the transfer of forces in order to maintain the sensor's signal stability and accuracy. Further, it is desirable to provide a physiological characteristic sensor assembly, such as a blood glucose sensor, that is flexible to conform the user's anatomy, and thus, improve user comfort during use. Furthermore, other desirable features and characteristics will become apparent from the subsequent detailed description and the appended claims, taken in conjunction with the accompanying drawings and the foregoing technical field and background.

SUMMARY

The techniques of this disclosure generally relate to a flexible physiological characteristic sensor assembly that includes at least one physiological characteristic sensor, such as a blood glucose sensor.

According to various embodiments, provided is a physiological characteristic sensor assembly. The physiological characteristic sensor assembly includes a flexible top housing including a needle port having a central opening, and a flexible lower housing defining a sensor bore through the lower housing, the sensor bore coaxial with the central opening of the needle port. The physiological characteristic sensor assembly also includes an electrical subsystem disposed between the top housing and the lower housing. The electrical subsystem includes a flexible printed circuit board having a sensor contact pad, a physiological characteristic sensor and an electrically conductive adhesive patch. The physiological characteristic sensor has a distal end that extends through the needle port and a proximal end that includes at least one electrical contact. The conductive adhesive patch electrically and physically couples the at least one electrical contact of the physiological characteristic sensor to the sensor contact pad of the flexible printed circuit board.

Also provided is a physiological characteristic sensor assembly. The physiological characteristic sensor assembly includes a flexible top housing including a needle port having a central opening, and a flexible lower housing defining a sensor bore through the lower housing, the sensor bore coaxial with the central opening of the needle port. The physiological characteristic sensor assembly includes an electrical subsystem disposed between the top housing and the lower housing. The electrical subsystem includes a rigid printed circuit board, a flexible printed circuit board, a sensor contact pad, a physiological characteristic sensor and an electrically conductive adhesive patch. The rigid printed circuit board is electrically coupled to the flexible printed circuit board and disposed between the flexible printed circuit board and the top housing. The physiological characteristic sensor has a distal end that extends through the needle port and a proximal end that includes at least one electrical contact. The conductive adhesive patch electrically and physically couples the at least one electrical contact of the physiological characteristic sensor to the sensor contact pad.

According to various embodiments, provided is a physiological characteristic sensor assembly. The physiological characteristic sensor assembly includes a flexible top housing including a needle port having a central opening, and a flexible lower housing defining a sensor bore through the lower housing, the sensor bore coaxial with the central opening of the needle port. The physiological characteristic sensor assembly includes an electrical subsystem disposed between the top housing and the lower housing. The electrical subsystem includes a rigid printed circuit board having a sensor contact pad, a physiological characteristic sensor and an electrically conductive adhesive patch. The physiological characteristic sensor has a distal end that extends through the needle port and a proximal end that includes at least one electrical contact. The conductive adhesive patch electrically couples the at least one electrical contact of the physiological characteristic sensor to the sensor contact pad.

Further provided is a method of assembling a physiological characteristic sensor assembly. The method includes coupling one or more electrical components to a rigid printed circuit board by temperature reflow soldering at a first temperature, and coupling the rigid printed circuit board to a flexible printed circuit board by temperature reflow soldering at a second temperature. The second temperature less than the first temperature. The rigid printed circuit board and the flexible printed circuit board form an electrical subsystem. The method includes coupling a power source to the flexible printed circuit board such that a portion of the flexible printed circuit board is folded over the power source, and electrically coupling a physiological characteristic sensor to the electrical subsystem. The method includes coupling a double sided adhesive layer to the electrical subsystem, and coupling a second double sided adhesive layer to the double sided adhesive layer such that a proximal end of a physiological characteristic sensor is positioned between the double sided adhesive layer and the second double sided adhesive layer to waterproof the proximal end of the physiological characteristic sensor. The method includes coupling at least a lower housing to the second double sided adhesive layer.

According to various embodiments, provided is a sensor introducer for a physiological characteristic sensor assembly. The sensor introducer includes a sensor introducer body that includes an outer housing that defines an opening to receive the physiological characteristic sensor assembly and an inner housing surrounded by the outer housing. The sensor introducer includes a cradle movable relative to the inner housing from a first position to a second position to deploy the physiological characteristic sensor assembly. The cradle has a cradle flange to receive the physiological characteristic sensor assembly and a cradle body that receives a needle assembly. The cradle body includes at least one locking projection that engages the inner housing to inhibit the movement of the cradle relative to the inner housing in the first position and the at least one locking projection is movable relative to the inner housing to enable the cradle to move from the first position to the second position.

Also provided according to various embodiments is a physiological characteristic sensor system. The system includes a physiological characteristic sensor assembly including a flexible top housing having an alignment feature, a flexible lower housing, an electrical subsystem disposed between the top housing and the lower housing. The electrical subsystem includes a physiological characteristic sensor and an adhesive patch having a first adhesive layer opposite a second adhesive layer, and the first adhesive layer is coupled to the electrical subsystem. The system includes a sensor introducer body that includes an outer housing that defines an opening and an inner housing surrounded by the outer housing. The sensor introducer body includes a cradle movable relative to the inner housing from a first position to a second position to deploy the physiological characteristic sensor assembly. The cradle has a flange that defines a recess that receives the physiological characteristic sensor assembly and a cradle body that receives a needle shuttle having a needle cradle. The sensor introducer includes a lid coupled to the outer housing to enclose the opening.

This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the detailed description. The details of one or more aspects of the disclosure are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the techniques described in this disclosure will be apparent from the description and drawings, and from the claims. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used as an aid in determining the scope of the claimed subject matter.

