The present invention is generally directed to devices that perform in vivo monitoring of at least one physiological parameter such as, but not limited to, perfusion, temperature or concentration of at least one analyte. In particular, the present invention is directed toward minimally invasive sensors that provide real-time information regarding the presence or concentration of an analyte or analytes such as, but not limited to, glucose, oxygen or lactate within a subject.
Diabetes is a growing healthcare crisis, affecting nearly 30 million people in the United States. Approximately 10 percent of those affected require intensive glucose and insulin management. In hospital patients, hypoglycemia in both diabetic and non-diabetic patients is associated with increased cost and short- and long-term mortality.
To prevent complications, diabetes requires ongoing management. Continuous glucose monitoring (CGM) has been shown in studies to be the most effective way to improve glucose control, whether used with insulin injections or a continuous insulin pump. CGM systems typically rely on sensors that are implanted under the skin for time periods varying between days and weeks. Efficacy of CGM can be further enhanced by monitoring additional analytes such as, but not limited to lactate and/or ketones. These continuous multianalyte sensors can improve insight into metabolic status that can lead to more personalized therapy or treatment that improves both short and long term patient outcomes.
However, improvements in care and outcome would ideally not come at the expense of user comfort and convenience. Having to insert multiple single analyte sensors to achieve multianalyte capability or having to insert a single relatively large multianalyte sensor may be perceived as encumbrances that dissuade users from adopting a continuous multianalyte sensor system. Thus, it continues to be advantageous to minimize the physical size of any implanted device.
Accordingly, it would be highly advantageous to enable the ability to selectively electrically short separate conductors within a single sensor assembly. The claimed invention seeks to address many issues associated with selectively electrically shorting separate conductors.
In one embodiment, a sensor assembly is disclosed. The sensor assembly having a first conductor and a second conductor being separated by an insulator. The sensor assembly further has an aperture that is formed through the first conductor, the second conductor and the insulator, wherein formation of the aperture creates an electrical short circuit between the first conductor and the second conductor.
In another embodiment a method of forming a sensor is disclosed. The method includes the operations of forming a first conductor having a first contact pad and forming a second conductor having a second contact pad. The method further includes the operations of separating the first conductor from the second conductor with an insulator and creating an aperture through the first conductor, the second conductor and the insulator, the creation of the aperture electrically shorting the first conductor to the second conductor.
In still another embodiment, a method of forming a sensor is disclosed. The method includes the operations to form a sensor with a first side and a second side, the second side being opposite the first side. The method further includes an operation to form a first conductor with a first contact pad on the first side and an operation to form a second conductor with a second contact pad on the second side. An additional operation separates the first conductor from the second conductor with an insulator. Further operations create a first aperture through the first conductor and the insulator and also create a second aperture through the second conductor and the insulator. Still additional operations fill the first aperture with a first supplemental conductor and further fill the second aperture with a second supplemental conductor. Wherein the first supplement conductor enables electrical contact to the first conductor on at least one of the first side or the second side and the second supplemental conductor enables electrical contact to at least one of the first side or the second side.
Other features and advantages of the invention will become apparent from the following detailed description, taken in conjunction with the accompanying drawings that illustrate, by way of example, various features of embodiments of the invention.
Presented below are embodiments that are intended to enable selectively creating an electrical short circuit between electrically isolated conductors. The ability to selectively create an electrical short circuit between electrically isolated conductors can enable minimally invasive implantable sensors to be miniaturized resulting in reduced insertion force and physical discomfort. In some embodiments, particularly those having the ability to measure multiple analytes using multiple conductors, each conductor can have their own respective working electrode, counter electrode and reference electrode. In alternative embodiments, each conductor can have their own respective working electrode and a combined counter/reference electrode, or pseudo-reference electrode. In still further alternative embodiments, the individual conductors can each have their own working electrode while sharing a common counter/reference (pseudo-reference) electrode.
The ability to selectively create the electrical short circuit between the conductors enables the shared counter/reference electrode. Thus, the selective electrical short circuit enables sensors that can be physically smaller because a single counter/reference electrode replaces two counter/reference electrodes or alternatively, two counter electrodes and two reference electrodes. From another perspective, the selective electrical short circuit enables increased area for a working electrode because the single counter/reference electrode has emancipated area on one of the conductors that would have been dedicated to a counter electrode and a reference electrode, or a counter/reference electrode. Though various features of different embodiments may be discussed individually, the various features and embodiments should be viewed as potentially being combined within another embodiment or other embodiments so long the intended operation of the combined embodiments is not compromised. Accordingly, the features described in each embodiment should be viewed as being combinable with the other features and embodiments discussed within the following pages.
In many examples discussed below sensor structures are discussed in reference to a sensor having two conductors. While embodiments and examples may be related to figures having a specific number of conductors capable of detecting a specific analyte or analytes, the scope of the disclosure and claims should not be construed to be limited to the number of conductors or analytes illustrated or discussed below. Rather it should be recognized that fewer or even additional conductors can assist or enable in the detection, diagnosis and monitoring of various metabolic conditions or general physiological health.
The sensor assembly 100 further includes a circuit board 110. The circuit board 110 may be comprised of multiple layers or rigid material, flexible material, or combinations thereof. The circuit board 110 enables electrical connection between the sensor 102 various electronic components such as, but not limited to a power supply 126, memory (not shown), radios to enable bidirectional communication (not shown) and an application specific integrated circuit (ASIC) (not shown). In some embodiments the electrical connection between the circuit board 110 and the sensor 102 is achieved via compression of conductive elastomers placed between the sensor 102 and the circuit board 110. In other embodiments, protrusions such as pins or bumps extend from the circuit board 110 to make electrical contact with contact pads on the sensor 102.
Conformal material 104 and 112 are selectively positioned within the sensor assembly 100 between the case top 124 and a case bottom. In one embodiment, the conformal material 104 is positioned between the case bottom 122 and the sensor 102. The durometer of conformal material 104 is selected to obtain sufficient compression to ensure electrical contact between the sensor 102 and the circuit board 110. Similarly, conformal material 112 is positioned between the case top 124 and the circuit board 110. The durometer of conformal material 112 also being selected to provide sufficient compression to ensure electrical contact between the sensor 102 and the circuit board.
The case bottom 122 includes an opening that enables a distal end of the sensor 102 to extend through the case bottom 122. The sensor passes through a bottom seal 106. The bottom seal 106 is selected from a flexible material that creates a fluid barrier to prevent fluids such as liquids from being introduced within an interior of the sensor assembly 100. In some embodiments the bottom seal 106 is molded into the case bottom 122. In other embodiments the bottom seal 106 is a discrete component that is placed within an opening in the case bottom 122. While a single bottom seal 106 is shown in
Separating the first conductor 202-1 and the second conductor 206-1 is a central insulator 204. Typically, the central insulator 204 is coupled to both the first conductor 202-1 and the second conductor 206-1 using an adhesive. In many embodiments the central insulator 204 is a material such as, but not limited to polyimide film. The sensor 102 further includes bottom insulation 200 that contains bottom opening 200-1 and optional bottom opening 200-2. The bottom opening 200-1 and optional bottom opening 200-2 define contact pads on the first portion 202a and optional second portion 202b of the first conductor. Similarly, top insulation 208 includes top opening 208-1 and optional top opening 208-2. Top opening 208-1 defines a contact pad for the second area 206b, while the top opening 208-2 defines a contact pad on the first area 206a of the second conductor 206-1.
In many embodiments the bottom insulation 200 and the top insulation 208 are the same material as the central insulator 204. Also, like the central insulator 204, the bottom insulation 200 and the top insulation 208 may be made from polyimide film and coupled to their respective conductors via an adhesive. The specific embodiments discussed above should not be construed as limiting. Various embodiments of the sensor 102 can include additional or different insulators and/or insulation materials, incorporate different or additional coupling mechanisms or different or additional materials for the first conductor and/or the second conductor. Furthermore, while the embodiments illustrated in
In many embodiments the apertures 300-1 and 300-2 are formed using a laser. Alternative embodiments form the apertures 300-1 and 300-2 using techniques such as, but not limited to punches or drills. In embodiments having more than one aperture, the apertures can be formed using the same technique while in other embodiments different techniques are used to form the multiple apertures. The formation of the aperture is intended to create a permanent electrical short between the first conductor 202-1 and the second conductor 206-1.
In embodiments where alternative mechanical techniques such as, but not limited to, drilling or punching are used to create the aperture 300-2, speed and sharpness of the drills or punches can be optimized to enable creation of an electrical short circuit between the first conductor 202-1 and the second conductor 206-1. The techniques described above are intended to be illustrative on preferred embodiments to create an electrical short circuit between the first conductor and the second conductor. Various other mechanical, electro-optical or other techniques may be used so long as the electrical short circuit between the first conductor and the second conductor is established as part of, or during the creation of the aperture. Furthermore, while the apertures 300-1 and 300-2 are illustrated as being through holes passing through the entirety of the sensor structure, in other embodiments an aperture may be a blind hole. In embodiments having multiple apertures, some apertures may be blind holes while other apertures are through holes.
In the embodiment illustrated in
In some embodiments the aperture can be overfilled or underfilled with the material 400 resulting in the material 400 extending beyond or below the surface of the first or second conductor exposed within the top opening or bottom opening. In other embodiments, the aperture can be filled such that the material 400 is substantially coincident with the first or second conductor exposed within the top opening or bottom opening. Underfill, overfill or coincident application of the material 400 within the aperture may be selected based on requirements for the electrical contact pads onto which they are disposed.
Operation 608 creates an aperture. The creation of the aperture in operation 608 also creates an electrical short circuit between the first conductor and the second conductor. In many embodiments operation 608 is accomplished with a laser. The laser being configured to generate slag that creates the electrical short circuit between the conductors. In other embodiments operation 608 is accomplished with a drill. Drill parameters such as, but not limited to rotational speed of the drill bit along with translation speed of the drill bit through the sensor can be configured or tuned to achieve the desired short circuit between the first and second conductors. In still other embodiments operation 608 is accomplished with a punch. As with the drill, punch parameters may require tuning in order to achieve the desired electrical short circuit between the first and second conductors. Operation 610 ends the process and completes the flowchart.
The specific operations, and particularly the order of operations, disclosed in the embodiments associated with
The embodiments discussed above are intended to be exemplary. For example, while many of the embodiments are related to sensing using two conductors, other embodiments can be related to generic subdermal sensing using a single conductor or a plurality of conductors to enable sensing or detection of analytes or compounds such as, but not limited to lactate, ketones, oxygen, glucose, reactive oxygen species and the like. Additionally, while many of the embodiments shown in the accompanying figures include a single aperture, various other embodiments can include multiple apertures, where creation of each aperture results in an electrical short circuit. Furthermore, the circular apertures shown in the accompanying figures should not be construed as limiting. Apertures can be formed in various shapes, sizes and at angles other than perpendicular to the sensor such as oblique or acute angles.
In many embodiments, additional features or elements can be included or added to the exemplary features described above. Alternatively, in other embodiments, fewer features or elements can be included or removed from the exemplary features described above. In still other embodiments, where possible, combination of elements or features discussed or disclosed incongruously may be combined together in a single embodiment rather than discreetly as in the exemplary discussion.
Accordingly, while the description above refers to particular embodiments of the invention, it will be understood that many modifications may be made without departing from the spirit thereof. The presently disclosed embodiments are therefore to be considered in all respects as illustrative and not restrictive, the scope of the invention being indicated by the appended claims, rather than the foregoing description, and all changes that come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein.
This application claims the benefit of U.S. provisional application No. 62/858,993 filed Jun. 8, 2019. The application listed above is hereby incorporated by reference in its entirety for all purposes.
Number | Date | Country | |
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62858993 | Jun 2019 | US |