Patent Application
20230301556
Embodiments of the present disclosure are directed to methods, systems, devices, and components thereof, configured for continuous monitoring of glucose in a patient. More particularly:
some embodiments of the present disclosure relate to a disposable glucose sensing device for continuous glucose monitoring; and
some embodiments of the present disclosure relate to a disposable mounting assembly for mounting a glucose sensor on a patient for such monitoring.
Continuous glucose monitoring is important to individuals with diabetes, as they must determine when insulin is needed to reduce glucose levels or when additional glucose is needed to raise the level of glucose. A continuous glucose monitoring device (CGM) usually adheres to a patient's skin and transmits glucose reading to a remote monitoring device. The CGM can be incorporated in a closed loop system (artificial pancreas) in which, an insulin pump automatically administers and adjusts insulin delivery according to CGM transmitted glucose readings (closed loop system).
There exists a need for a fully disposable sensing device for continuous monitoring of glucose. There is also a need for a planar sensor probe having a minimal surface area and maximal electrodes surface area. There is also a need for a mounting device which is easy to use, minimizes pain, and minimizes insertion trauma. There is also a need for a mounting device that is fully automatic in which insertion and retraction of introducer sharp is done by a button press with no patient's intervention in spring pre-loading. There is also a need for a one piece, disposable mounting device that is pre-assembled in the factory and includes the sterilized sensor probe and the non-sterilized components and thus, reducing mounting steps at each device replacement. There is also a need for a one piece disposable mounting device that is cheap for production in which the relatively expensive spring loaded mechanism is not sterilized.
Embodiments of the present disclosure, present, among many embodiments, a fully disposable, one piece continuous glucose monitoring (CGM) device (sensing device), which in some embodiments includes a sensor and a sensor probe, and a fully disposable, one piece, mounting assembly/unit for mounting the CGM device (mounting assembly, both mounting unit and mounting assembly used interchangeably). The device and the mounting unit are pre-assembled in the factory to a one piece, disposable, mounting assembly. The mounting assembly is comprised of sealed compartment that includes a portion of the sensor and a non-sealed compartment that includes another portion of the sensor. The mounting assembly can be partially, and preferably, fully automatic, at a button press—the sensor is adhered to the skin, and the sensor probe is inserted into the subcutaneous tissue.
The sensor probe, in some embodiments, includes a first portion which is inserted in the subcutaneous tissue and a second portion adapted to be received in a sensor housing (together the sensor probe, the glucose sensor, and sensor housing comprising a sensing device, as noted above). The sensor housing includes an upper cover and a lower cover, the lower cover including an adhesive, in some embodiments, for adhering the sensor to the skin. Following use, the sensing device (i.e., the sensor housing and sensor probe), in some embodiments, is removed from the body and disposed.
In some embodiments, the sensor comprises an electronic printed circuit board assembly (“PCBA” or “electronics”) and may also include a variety of optional components, such as, for example, a receiver, a transmitter, a processing circuit, a battery, an alarm system, and/or a data storage unit. In some embodiments, the sensor includes a plurality of conductive contacts, e.g., two or more conductive contacts (e.g., conductive springs), that can be configured for coupling to two or more respective contact pads on the sensor probe. The sensor probe, in some embodiments, includes at least one working electrode, a counter electrode, at least two (2) electrical conductors, and at least two (2) contact pads. In some embodiments, the probe is planar and includes two (2) electrodes—a working electrode which can be positioned on one side of the probe, in some embodiments, at the distal end of the probe, and a counter electrode positioned, in some embodiments, on the opposite side. Both electrodes, in some embodiments, are connected with electrical conductors to contact pads that can be positioned on both sides of a contact(s) plate(s). The contact plate, in some embodiments, is perpendicular to the probe (and in some embodiments, can be a part of the probe) and can reside within the sensor housing such that at least one (1) contact pad is facing the PCBA, and another (e.g., the other) contact pad is facing the opposite direction. In some embodiments, the contacts plate is folded on one (1) side at 180 degrees such that both contact pads are facing the PCBA and thus, simplifying electrical connection. In some embodiments, the probe and the contact(s) plate(s) are made from a single matrix sheet (e.g. polyimide) folded such that the probe is configured to be perpendicular to the skin, the contacts plate is perpendicular to the probe (parallel to skin), and both contact pads are facing the PCBA.
According to some embodiments, a mounting unit is provided and configured for mounting the sensing device (e.g., see above embodiments) onto a patient. The mounting unit can be pre-assembled with the sensing device such that the mounting unit and the sensing device (which includes, in some embodiments, the sensor and the sensor probe) are provided in one piece (mounting assembly) that is packed in one box. The mounting unit, in some embodiments, is comprised of two compartments having two pre-assembled housings, a non-sealed, non-sterilized compartment (spring compartment) that includes the insertion and retraction mechanisms and a portion of the sensing device, and a sealed, sterilized compartment (probe compartment) that includes the sensor probe. Both compartments have housings, a spring compartment housing and a probe compartment housing, that are rigidly pre-assembled during manufacture (for example), the spring compartment housing on top of the probe compartment housing. The probe compartment is preferably sealed and sterilized with radiation (e.g., gamma or e-beam). Before device mounting, the patient removes a protecting lid from the bottom side of the sensor probe housing and adheres the mounting assembly to the skin. During device mounting, the sensor and sensor probe are displaced within the sensor probe housing and mounted onto the patient (with the probe being inserted into tissue).
In some embodiments, an introducer for insertion of the sensor probe into the subcutaneous tissue is provided. The introducer, in some embodiments, includes a sharp tip at one end which is configured to penetrate the skin, and an introducer cap, at the other end, which is configured to drive the introducer in one direction during insertion and the opposite direction during retraction. The introducer, in some embodiments, is positioned within the mounting assembly and spans the non-sterilized compartment, the sterilized compartment, and an elastomeric septum (that provides sealing to the sealed, sterilized probe compartment). The introducer can be displaced through the septum in one direction during sensor probe insertion, and then, in an opposite direction during introducer retraction. Following device mounting, the mounting unit can be removed from the body leaving the sensor on the skin and the sensor probe within the subcutaneous tissue.
In some embodiments, after triggering, operation of the mounting unit is automatic. For example, upon pressing an operating button, the mounting unit adheres the sensor to the patient's skin, inserts the sensor probe into the subcutaneous tissue (mounting phase one) and retracts the sensor probe introducer while the sensor probe remains within the body (mounting phase two). After device mounting, the mounting unit can be removed from the body and disposed. In some embodiments, the mounting unit includes a spring loaded driving mechanism for mounting the device onto the patient, and a spring loaded retraction mechanism for removing the introducer while leaving the sensor on the patient. Upon pressing an operating button, a trigger releases a pre-loaded insertion spring that drives the device (including the sensor, sensor probe, and introducer) in a first direction. At the end of movement, a preloaded retraction spring is released, and the introducer is retracted in a second opposite direction such that the introducer sharp is concealed within the mounting unit. In some embodiments, the introducer is a rigid planar structure having a sharp tip and adapted to support the sensor probe during insertion. The introducer and sensor probe can concomitantly be inserted into the subcutaneous tissue; however, in some embodiments, at the end of movement of the introducer at first direction, the sensor probe is further advanced (e.g., for additional 1-3 mm) in the same first direction. Thus, in such embodiments, local trauma within the surrounding tissue can be minimized because the cross profile of the sensor probe is very low (e.g., causes minimal trauma) and the glucose sensing electrode (i.e., the working electrode), that is located at the distal end of the probe, is exposed to a minimal local inflammatory reaction.
An assembly process for the device, according to some embodiments, includes the following steps (which in some embodiments, consecutive steps):
deposition of glucose sensitive layers, electrical conductors, insulators, and contact pads on one or both sides of a matrix sheet;
cutting and/or folding the matrix sheet such that it is configured to include the sensor probe and the contacts plate; and
assembly (and in some embodiments, sterilization) of the probe compartment, and assembly (stacking bottom-up) of the sensor PCBA, sensor housing upper cover, retraction spring, introducer cap and finally, the spring's compartment housing that includes the spring loaded insertion mechanism.
According to some embodiments, a method of mounting the device is provided, which includes the following steps (in some embodiments, consecutive steps): removal of the protecting lid, placement of mounting assembly on the skin, button press, and removal of mounting unit.
In some embodiments, a continuous glucose monitoring system for continuously monitoring glucose levels of a user is provided. The system includes a mounting assembly, and a sensing device, where at least a portion of the sensing device is housed within the mounting assembly prior to mounting the sensing device on the user. It is worth noting, that each of these components are separate embodiments in and to themselves.
The above noted embodiments, including separate embodiments of the mounting assembly and the sensing device, may also include one and/or another (and in some embodiments, a plurality of, a majority of, substantially all of, and in some embodiments, all of) the following additional features, functionality, structure, steps, or clarifications, yielding yet further embodiments (as is clear from the listing below, some of the additional features, functionality, structure, steps, and clarifications—as may be the case—build off of, and/or are based on, previously/earlier recited additional features, functionality, structure, steps, or clarifications):
the sensing device can include at least a transmitter configured to transmit signals corresponding to sensed glucose levels of the user;
a remote display unit configured with at least with a receiver for receiving the sensed glucose readings from the sensing device via the transmitter;
the sensing device can comprise a sensor;
the sensing device can comprise a sensor, and a sensor probe configured for insertion into the subcutaneous tissue of the user;
the sensing device can comprise a sensor configured for adhering to the skin of the user, and a sensor probe configured for insertion into the subcutaneous tissue of the user;
the sensor housing can comprise an upper cover and a lower cover; where the lower cover can include an adhesive for adhering the sensor to the skin of the patient;
the sensor can include a printed circuit board assembly (PCBA);
at least one of the sensor housing and the PCBA can also include at least one, a plurality of, a majority of, substantially all of, or all of, a receiver, a transmitter, a processing circuit, a battery, an alarm system, and data storage means, where the receiver and the transmitter can together comprise a transceiver;
the sensor can include at least one, and preferably, a plurality of conductive contacts configured for coupling to one or more respective contact pads of the sensor probe;
the sensor probe can include:
the sensor probe can be configured with a planar shape, and includes at least two (2) electrodes, where the at least two (2) electrodes comprises at least a working electrode;
the working electrode can be configured for positioning on at least one of a first side of the sensor probe and at a distal end thereof;
the at least two (2) electrodes can comprise a counter electrode;
the at least two (2) electrodes can comprise at least a working electrode and a counter electrode, where the working electrode is configured for positioning on at least one of a first side of the sensor probe and at a distal end thereof, and the counter electrode is configured for arrangement on a side of the sensor probe opposite to the side where the working electrode is positioned on the sensor probe;
each electrode can be connected via electrical conductors to a respective contact pad;
one or more contact pads can be configured:
the contacts plate can be:
upon the contacts plate being positioned within the sensor housing (see above), at least one (1) contact pad can be facing the PCBA, and optionally, another (e.g., the other) contact pad can be facing an opposite direction;
the contacts plate can be folded on a first side at 180 degrees, such that each contact pad is facing the PCBA (see above);
the sensor probe and the contacts plates can be constructed from a matrix sheet configured such that the sensor probe is perpendicular to the skin, the contacts plate is perpendicular to the sensor probe (parallel to skin), and both contact pads are facing the PCBA;
the matrix sheet can comprise a single matrix sheet;
the mounting assembly can be configured for mounting the sensing device onto a patient;
the mounting assembly can be assembled with the sensing device during manufacture, such that it is ready to mount the sensing device onto a patient;
the mounting assembly can comprise a first, non-sealed, non-sterilized compartment, and a second sealed, sterilized compartment (in some embodiments, both compartments can be sterilized);
at least one of the first and second compartments can each include a housing;
the first compartment can be arranged immediately adjacent the second compartment;
the first compartment can include at least one of an insertion means and a retraction means;
the first compartment can include an insertion means and a retraction means;
the second compartment can include at least one of the sensor probe and a portion of the sensor;
the second compartment can include the sensor probe and a portion of the sensor, and optionally an elastomeric septum configured to sealing the second compartment;
the second compartment can include a protection lid;
a side of the second compartment from which the protection lid is removed can be configured for placement adjacent to the skin of the patient;
upon mounting the sensing device, at least one of the sensor and sensor probe can be displaced within the second compartment and mounted onto the patient;
upon mounting the sensing device, the sensor and sensor probe can be displaced within the second compartment and mounted onto the patient;
a sensor-probe introducer (“introducer”) configured to insert the sensor probe into the subcutaneous tissue of the patient;
the introducer can comprise at least one of, a plurality of, a majority of, substantially all of, or preferably all of:
and
the introducer:
the mounting assembly can be configured to automatically operate, including automatically adhering the sensor to the patient's skin, inserting the sensor probe into the subcutaneous tissue, and retracting the sensor probe introducer;
a trigger configured to initiate the automatic operation of the mounting assembly to mount the sensing device on the user;
the trigger can include an operating button or an operating switch configured to receive user or operator input;
the insertion means can comprise a spring loaded driving mechanism configured to mount the sensing device onto the patient;
the retraction means can comprise a spring loaded retraction mechanism for removing the introducer while leaving the sensing device on the patient;
upon pressing a/the operating button, the trigger can be configured to release the insertion spring of the insertion means that drives the sensing device, including the sensor, the sensor probe, and optionally the introducer, in a first direction, thereafter, the retraction spring can be configured to release and the introducer can be retracted in a second opposite direction such that the sharp end of the introducer can be at least substantially concealed within the mounting unit;
at the end of insertion, the sensor probe can be further advanced in the first direction (e.g., 1-3 mm);
both the first and the compartments can be sterilized compartments;
and
the second compartment (i.e., probe compartment) can be sterilized first with an e-beam and/or gamma radiation, followed by the first compartment (i.e., spring compartment) which can be sterilized with a gas (e.g., ethylene oxide).
In some embodiments, a glucose monitoring sensing device mounting assembly according to any of the above noted embodiments (and any other embodiments of this disclosure) is provided.
In some embodiments, a glucose monitoring sensing device according to any of the above-noted embodiments (and any other embodiments of this disclosure) is provided.
In some embodiments, an assembly method for assembling a mounting assembly and a sensing device for a continuous glucose monitoring system is provided and includes assembling a/the sensing device and assembling a/the mounting assembly (each according to any of the disclosed embodiments). For assembling the sensing device, the method includes at least one of, and preferably a plurality of, and most preferably all of:
depositing glucose sensitive layers, electrical conductors, insulators, and contact pads on one or both sides of a matrix sheet, such depositing includes forming one or more electrodes on the matrix sheet;
cutting and/or folding the matrix sheet such that it is configured to include the sensor probe and the contacts plate; and
assembling of the sensor contacts plate, sensor printed-circuit-board-assembly (PCBA), and sensor housing as to form a sensor
For assembling of the mounting assembly, the method includes at least one of, and preferable a plurality of, and most preferably all of:
assembling at least one of an insertion spring and a retraction spring into a first compartment of the mounting assembly;
assembling and sterilizing a second compartment of the mounting assembly; and
placing at least a portion of the sensing device in the second compartment.
Such method embodiments, including separate embodiments of the mounting assembly and the sensing device, may also include one and/or another (and in some embodiments, a plurality of, substantially all of, and in some embodiments, all of) the following additional features, functionality, structure, steps, or clarifications, yielding yet further embodiments (as is clear from the listing, some of the additional features, functionality, structure, steps, and clarifications—as may be the case—build off of, and/or are based on, previously/earlier recited additional features, functionality, structure, steps, or clarifications):
both the first and the second compartments can be sterilized;
the second compartment is sterilized first with an e-beam and/or gamma radiation, followed by the first compartment which is sterilized with a gas (e.g., ethylene oxide);
at least one of the probe and contacts plate are formed on/from the matrix sheet;
the sensor probe and/or the contacts plate can be formed on/from the matrix sheet;
at least one of the sensor probe and the contacts plate can be formed on/from the matrix sheet via cutting and/or folding so as to form an/the appropriate spatial configuration;
at least one of the one or more electrodes, one or more conductors, and one or more contact pads, can be positioned on at least one side of the matrix sheet;
at least one of the one or more electrodes, one or more conductors, and one or more contact pads, can be positioned on both sides of one matrix sheet;
and
the folding of contacts plate can be configured to arrange the contact pads to face the same direction, where the same direction can be towards the PCBA.
These and other embodiments, advantages, and objects thereof, of the various inventions of the present disclosure are even more evident given the detailed description of at least some of the embodiments which follow, as well as the figures that form part of this disclosure (a brief description of which is outlined below).
FIGS. 15A1-3 show a side view (15A1), a top view (15A2), and a cross-sectional view (15A3) of an introducer tip, according to some embodiments.
FIGS. 15B1-2 show a side view (15B1) and a top view (15B2) of an introducer tip and a sensor probe tip, according to some embodiments.
FIGS. 18A1-F1 and 18A2-F2 show spatial views (18A1-F1) and oblique cross-sectional views (18A2-F2), respectively, of consecutive assembly stages of a mounting assembly, according to some embodiments.
The following reference numbers and associated terms are used to describe various structure, according to at least some embodiments of the present disclosure.
Mounting assembly 1, in some embodiments, is comprised of two (2) compartments: a non-sterilized, non-sealed compartment, which may also be referred to as a first or spring compartment 9, and a second, sterilized, sealed compartment, which may also be referred to as a probe compartment 6. The sensor, in some embodiments, comprises at least two (2) components that can be pre-assembled during manufacture: a sensor control unit, which in some embodiments, includes a housing adapted for placement on the skin, and a sensor probe 60 that has a first portion configured for insertion in the subcutaneous tissue and a second portion configured for being received in a sensor housing. Sensor probe 60, in some embodiments, includes a glucose sensitive enzyme configured for detecting glucose levels in the interstitial fluid within the subcutaneous tissue. Sensor 50, in some embodiments, is positioned within mounting assembly 10 such that at least a first portion of sensor 50 can be received in the sealed, sterilized compartment (second/probe compartment 6), and at least another portion (e.g., second portion) of sensor 50, which includes a PCBA 53, which is adopted to be received in the non-sealed, non-sterilized compartment (spring compartment 9).
In some embodiments, both compartments of mounting assembly 1 are sterilized. In this configuration, second/probe compartment 6 is sterilized with, for example, an e-beam or gamma radiation, and spring compartment 9 is sterilized with a gas (e.g., ethylene oxide). The portion of sensor 50 which includes PCBA 53, in some embodiments, is configured to be received in a sterilized compartment (spring compartment 9).
In some embodiments, an introducer 20 is included, which is configured for inserting sensor probe 60 into subcutaneous tissue. Introducer 20, in such embodiments, may be positioned within mounting assembly 1, and can span non-sterilized spring compartment 9, sterilized probe compartment 6, and an elastomeric septum 52. Probe compartment 6 can include a housing 16, a removable lid 17, a portion of sensor 50, and a portion of introducer 20. Sealing can be provided by a protecting lid seal 174, probe compartment seal 162, and septum 52.
The spring compartment, in some embodiments, includes a housing 19, a portion of introducer 20, and spring mechanisms (not shown) for driving introducer 20 in a first direction (e.g., probe 60 insertion), and a second direction, opposite to the first direction (e.g., introducer 20 retraction). In some embodiments, before use, a patient removes protecting lid 17 providing a free forward movement (e.g., in
The spring mechanisms, in some embodiments, include at least a plurality of (and in some embodiments, all of) an operating button 11, a trigger 12, trigger latches 18, a sleeve 13, hammer 14, insertion spring 31, retraction spring 32, and retraction spring latch 155. Accordingly, following a press of operating button 11, trigger 12 releases hammer 14, insertion spring 31 drives hammer 14 in a first direction (e.g., forward) which drives introducer cap 21, introducer 20, and sensor 50 in the same direction. When introducer cap 21 reaches the end of the forward movement (e.g., end of a first mounting phase), in some embodiments, it releases retraction spring latch 155 and retraction spring 32 drives introducer cap 21 and introducer 20 in a second direction, opposite to the first direction (e.g., backward) direction.
In some embodiments, the insertion mechanism includes operating button 11, trigger 12, sleeve 13, hammer 14, and insertion spring 31. The hammer 14 can include the introducer pulling lever 141, and sensor pushing lever 142 (e.g., three (3) levers). In some embodiments, the release mechanism includes retraction spring 32 and retraction spring latch 155. In some embodiments, before use, the protecting lid is removed by patient, and upon pressing of operating button 11, trigger 12 releases the hammer 14 and insertion spring 31 drives hammer 14 in a (first) forward direction within sleeve 13. In some embodiments, hammer introducer pulling lever 141, that is connected to introducer cap snap 211, drives introducer 20 in the (first) forward direction, and concomitantly (in some embodiments), the hammer sensor pushing levers 142 drive sensor 50 and sensor probe 60 also in the (first) forward direction. At the end of forward movement of hammer 14 (end of the first mounting phase), introducer cap knob 213 releases retraction spring 32 which drives introducer cap 21 in an opposite (second), e.g., backward, direction.
In some embodiments, the working electrode and the counter electrode (and, if required, a reference electrode) are deposited on one side of the matrix sheet.
The sensor probe 60 is relatively thin 50-100 microns such that and movement within the subcutaneous tissue causes minimal trauma.
FIGS. 18A1-F1 and 18A2-F2 show spatial views (18A1-F1) and oblique views (18A2-F2), respectively, of the various assembly stages of the mounting assembly 1, according to some embodiments. FIGS. 18A1-2 show sterile probe compartment 6 after assembly (e.g., assembly process shown in
At a later stage of assembly, according to some embodiments, spring compartment housing 19 can be rigidly connected to probe compartment housing 16 forming mounting assembly 1 (as shown in
While various inventive embodiments have been described and illustrated herein, those of ordinary skill in the art will readily envision a variety of other means and/or structures for performing the function, and/or obtaining the results and/or one or more of the objects/advantages described herein, and each of such variations and/or modifications is deemed to be within the scope of the inventive embodiments described herein. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, steps, and configurations described herein are meant to be merely an example and that the actual parameters, dimensions, materials, steps, and configurations will depend upon the specific application or applications for which the inventive teachings is/are used. Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific inventive embodiments described herein. It is therefore to be understood that the foregoing embodiments are presented by way of example only and that, within the scope of claims supported by the subject disclosure and equivalents thereto, and inventive embodiments may be practiced otherwise than as specifically described and claimed. Inventive embodiments of the present disclosure are directed to each individual feature, device, system, article, material, kit, step, function/functionality, and method described herein. In addition, any combination of two or more such features, devices, systems, articles, materials, kits, steps, functions/functionality, and methods, if such features, systems, articles, materials, kits, steps, functions/functionality, and methods are not mutually inconsistent, is included within the inventive scope of the present disclosure, and considered embodiments.
Embodiments disclosed herein may also be combined with one or more features, as well as complete systems, devices, and/or methods, to yield yet other embodiments and inventions. Moreover, some embodiments, may be distinguishable from the prior art by specifically lacking one and/or another feature disclosed in the particular prior art reference(s); i.e., claims to some embodiments may be distinguishable from the prior art by including one or more negative limitations.
Also, as noted, various inventive concepts may be embodied as one or more methods. The acts performed as part of the method(s) may be ordered in any suitable way. Accordingly, embodiments may be constructed in which acts are performed in an order different than illustrated, which may include performing some acts simultaneously, even though shown as sequential acts in illustrative embodiments.
Any and all references to publications or other documents, including but not limited to, patents, patent applications, articles, webpages, books, etc., presented anywhere in the present application, are herein incorporated by reference in their entirety. Moreover, all definitions, as defined and used herein, should be understood to control over dictionary definitions, definitions in documents incorporated by reference, and/or ordinary meanings of the defined terms.
The indefinite articles “a” and “an,” as used herein in the specification and in the claims, unless clearly indicated to the contrary, should be understood to mean “at least one.”
The terms “can” and “may” are used interchangeably in the present disclosure, and indicate that the referred to element, component, structure, function, functionality, objective, advantage, operation, step, process, apparatus, system, device, result, or clarification, has the ability to be used, included, or produced, or otherwise stand for the proposition indicated in the statement for which the term is used (or referred to).
The phrase “and/or,” as used herein in the specification and in the claims, should be understood to mean “either or both” of the elements so conjoined, i.e., elements that are conjunctively present in some cases and disjunctively present in other cases. Multiple elements listed with “and/or” should be construed in the same fashion, i.e., “one or more” of the elements so conjoined. Other elements may optionally be present other than the elements specifically identified by the “and/or” clause, whether related or unrelated to those elements specifically identified. Thus, as a non-limiting example, a reference to “A and/or B”, when used in conjunction with open-ended language such as “comprising” can refer, in one embodiment, to A only (optionally including elements other than B); in another embodiment, to B only (optionally including elements other than A); in yet another embodiment, to both A and B (optionally including other elements); etc.
As used herein in the specification and in the claims, “or” should be understood to have the same meaning as “and/or” as defined above. For example, when separating items in a list, “or” or “and/or” shall be interpreted as being inclusive, i.e., the inclusion of at least one, but also including more than one, of a number or list of elements, and, optionally, additional unlisted items. Only terms clearly indicated to the contrary, such as “only one of” or “exactly one of,” or, when used in the claims, “consisting of,” will refer to the inclusion of exactly one element of a number or list of elements. In general, the term “or” as used herein shall only be interpreted as indicating exclusive alternatives (i.e. “one or the other but not both”) when preceded by terms of exclusivity, such as “either,” “one of,” “only one of,” or “exactly one of” “Consisting essentially of,” when used in the claims, shall have its ordinary meaning as used in the field of patent law.
As used herein in the specification and in the claims, the phrase “at least one,” in reference to a list of one or more elements, should be understood to mean at least one element selected from any one or more of the elements in the list of elements, but not necessarily including at least one of each and every element specifically listed within the list of elements and not excluding any combinations of elements in the list of elements. This definition also allows that elements may optionally be present other than the elements specifically identified within the list of elements to which the phrase “at least one” refers, whether related or unrelated to those elements specifically identified. Thus, as a non-limiting example, “at least one of A and B” (or, equivalently, “at least one of A or B,” or, equivalently “at least one of A and/or B”) can refer, in one embodiment, to at least one, optionally including more than one, A, with no B present (and optionally including elements other than B); in another embodiment, to at least one, optionally including more than one, B, with no A present (and optionally including elements other than A); in yet another embodiment, to at least one, optionally including more than one, A, and at least one, optionally including more than one, B (and optionally including other elements); etc.
In the claims, as well as in the specification above, all transitional phrases such as “comprising,” “including,” “carrying,” “having,” “containing,” “involving,” “holding,” “composed of,” and the like are to be understood to be open-ended, i.e., to mean including but not limited to. Only the transitional phrases “consisting of” and “consisting essentially of” shall be closed or semi-closed transitional phrases, respectively, as set forth in the United States Patent Office Manual of Patent Examining Procedures, Section 2111.03.
This disclosure claims priority to and benefit of U.S. provisional patent application ///no. 63/070,735, filed Aug. 26, 2020, entitled, “Continuous Glucose Sensor and Mounting Assembly,” and U.S. provisional application /no. 63/072,050, filed Aug. 28, 2020, entitled, “Systems, Devices and Methods for Glucose Sensing and associated manufacturing methods.” Each of these disclosures in its entirety is incorporated herein by reference.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/IL2021/051052 | 8/26/2021 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 63070735 | Aug 2020 | US | |
| 63072050 | Aug 2020 | US |
