Different designs of an analyte sensor applicator for applying a wearable analyte monitoring device are disclosed. The analyte sensor applicator includes a housing that holds an analyte sensor assembly, a cam assembly for delivering the analyte sensor assembly, and a skin piercing for inserting a sensor, wherein the skin piercing device is retracted within the housing top after insertion.
The disclosed opto-enzymatic analyte physiological sensors exhibit improved bonding or adherence between at least two layers of the sensor, either directly or through an intermediate layer, which provides improved function of the sensor. In certain embodiments, there is bonding or adherence of the enzymatic hydrogel to the target analyte dependent oxygen sensing polymer matrix, either directly or through an intermediate barrier layer, such that changes in the partial pressure of oxygen in the enzymatic hydrogel matrix are rapidly reflected in the partial pressure of oxygen in the oxygen sensing matrix. The sensors provide an implantable, wearable, disposable and ideally low-cost way to continuously sense one or more analytes in the body, such as glucose.
G01N 31/22 - Investigating or analysing non-biological materials by the use of the chemical methods specified in the subgroupsApparatus specially adapted for such methods using chemical indicators
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value
A61B 5/1455 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value using optical sensors, e.g. spectral photometrical oximeters
G01N 21/77 - Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator
An analyte sensor applicator for applying a wearable analyte monitoring device includes a housing that holds an analyte sensor assembly, a cam assembly for delivering the analyte sensor assembly, and a skin piercing for inserting a sensor, wherein the skin piercing device is retracted within the housing top after insertion.
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value
A61B 50/30 - Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments
An analyte sensor applicator for applying a wearable analyte monitoring device includes a housing that holds an analyte sensor assembly, a cam assembly for delivering the analyte sensor assembly, and a skin piercing for inserting a sensor, wherein the skin piercing device is retracted within the housing top after insertion.
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value
A61B 5/1473 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value using chemical or electrochemical methods, e.g. by polarographic means invasive, e.g. introduced into the body by a catheter
An inserter for a medical device, where the inserter includes a housing having a first end with an opening therein, an actuator connected to a first gear, an actuator biasing element, a cam gear assembly including a cam member and a second gear, a cam bridge follower in contact with the cam member, and a first plunger assembly having a first plunger and a first biasing element.
Certain embodiments described herein pertain to optical sensors, systems and methods for continuous glucose monitoring. In some embodiments, methods of preparing a layered optical sensor are disclosed. The optical sensor can be formed by laminating a plurality of sheets together to form a final sensor. In some embodiments, the sensor tip comprises a oxygen conduit, an enzymatic layer, and an sensing layer. In some embodiments, the sensor includes a plurality of waveguides configured to direct light to and from a target material, such as an oxygen sensing polymer. Systems are also disclosed for an adhesive system for attaching an optical sensor-transmitter system. Methods and systems are also disclosed for a sensor inserter system. The inserter can include a lancet tip that includes a convex feature attached to a first surface of the lancet tip.
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
A61B 5/1459 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value using optical sensors, e.g. spectral photometrical oximeters invasive, e.g. introduced into the body by a catheter
A61B 5/1486 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value using chemical or electrochemical methods, e.g. by polarographic means using enzyme electrodes, e.g. with immobilised oxidase
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value
8.
Systems and methods for continuous health monitoring using an opto-enzymatic analyte sensor
Certain embodiments described herein pertain to optical sensors, systems and methods for continuous glucose monitoring. In some embodiments, methods of preparing a layered optical sensor are disclosed. The optical sensor can be formed by laminating a plurality of sheets together to form a final sensor. In some embodiments, the sensor tip comprises a oxygen conduit, an enzymatic layer, and an sensing layer. In some embodiments, the sensor includes a plurality of waveguides configured to direct light to and from a target material, such as an oxygen sensing polymer. Systems are also disclosed for an adhesive system for attaching an optical sensor-transmitter system. Methods and systems are also disclosed for a sensor inserter system. The inserter can include a lancet tip that includes a convex feature attached to a first surface of the lancet tip.
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
A61B 5/1459 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value using optical sensors, e.g. spectral photometrical oximeters invasive, e.g. introduced into the body by a catheter
A61B 5/1486 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value using chemical or electrochemical methods, e.g. by polarographic means using enzyme electrodes, e.g. with immobilised oxidase
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value
An inserter for a medical device, where the inserter includes a housing having a first end with an opening therein, an actuator connected to a first gear, an actuator biasing element, a cam gear assembly including a cam member and a second gear, a cam bridge follower in contact with the cam member, and a first plunger assembly having a first plunger and a first biasing element.
A61B 5/151 - Devices for taking samples of blood specially adapted for taking samples of capillary blood, e.g. by lancets
A61M 5/32 - NeedlesDetails of needles pertaining to their connection with syringe or hubAccessories for bringing the needle into, or holding the needle on, the bodyDevices for protection of needles
An inserter for a medical device, where the inserter includes a housing having a first end with an opening therein, an actuator connected to a first gear, an actuator biasing element, a cam gear assembly including a cam member and a second gear, a cam bridge follower in contact with the cam member, and a first plunger assembly having a first plunger and a first biasing element.
A61M 5/32 - NeedlesDetails of needles pertaining to their connection with syringe or hubAccessories for bringing the needle into, or holding the needle on, the bodyDevices for protection of needles
A61B 5/151 - Devices for taking samples of blood specially adapted for taking samples of capillary blood, e.g. by lancets
11.
ANALYTE SENSORS AND METHODS OF MANUFACTURING ANALYTE SENSORS
A method of manufacturing laminate structure including the steps of providing a waveguide structure having a plurality of waveguide cores and including a first surface, creating an oxygen sensing polymer cavity in the first surface of the waveguide structure to receive an oxygen sensing polymer, filling the oxygen sensing polymer cavity with the oxygen sensing polymer and curing the oxygen sensing polymer, adding a first layer material on top of the first surface of the waveguide structure, where the first layer material includes a reaction chamber cavity that is contiguous with the oxygen sensing polymer, filling the reaction chamber cavity with an enzymatic hydrogel and curing the enzymatic hydrogel; adding a second layer material on top of the first layer material, where the second layer material includes a conduit cavity to receive a conduit hydrogel, filling the conduit cavity with a conduit hydrogel and curing the conduit hydrogel, and adding a top cap on top of the second layer of material.
An adhesive system having a first layer including a first layer material having a top and a bottom having a bottom perimeter, and a first layer adhesive on the bottom for attaching to skin, the first layer having an inherent modulus of elasticity. The adhesive system also includes a second adhesive along only the bottom perimeter, where the first layer includes a plurality of modifications therein that result in the first layer having an effective modulus of elasticity that is lower than the first layer's inherent modulus of elasticity.
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value
A61B 5/1455 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value using optical sensors, e.g. spectral photometrical oximeters
A61F 13/0246 - Adhesive bandages or dressings characterised by the skin-adhering layer
13.
ADHESIVE SYSTEMS HAVING AN AGGRESSIVE ADHESIVE OUTER RING AND HAVING A LOW EFFECTIVE MODULUS OF ELASTICITY
An adhesive system having a first layer including a first layer material having a top and a bottom having a bottom perimeter, and a first layer adhesive on the bottom for attaching to skin, the first layer having an inherent modulus of elasticity. The adhesive system also includes a second adhesive along only the bottom perimeter, where the first layer includes a plurality of modifications therein that result in the first layer having an effective modulus of elasticity that is lower than the first layer's inherent modulus of elasticity.
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value
A61B 5/1455 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value using optical sensors, e.g. spectral photometrical oximeters
A61B 5/1477 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value using chemical or electrochemical methods, e.g. by polarographic means non-invasive
14.
SYSTEMS AND METHODS FOR CONTINUOUS HEALTH MONITORING USING AN OPTO-ENZYMATIC ANALYTE SENSOR
Certain embodiments described herein pertain to optical sensors, systems and methods for continuous glucose monitoring. In some embodiments, methods of preparing a layered optical sensor are disclosed. The optical sensor can be formed by laminating a plurality of sheets together to form a final sensor. In some embodiments, the sensor tip comprises a oxygen conduit, an enzymatic layer, and an sensing layer. In some embodiments, the sensor includes a plurality of waveguides configured to direct light to and from a target material, such as an oxygen sensing polymer. Systems are also disclosed for an adhesive system for attaching an optical sensor-transmitter system. Methods and systems are also disclosed for a sensor inserter system. The inserter can include a lancet tip that includes a convex feature attached to a first surface of the lancet tip.
Certain embodiments described herein pertain to optical sensors, systems and methods for continuous glucose monitoring. In some embodiments, methods of preparing a layered optical sensor are disclosed. The optical sensor can be formed by laminating a plurality of sheets together to form a final sensor. In some embodiments, the sensor tip comprises a oxygen conduit, an enzymatic layer, and an sensing layer. In some embodiments, the sensor includes a plurality of waveguides configured to direct light to and from a target material, such as an oxygen sensing polymer. Systems are also disclosed for an adhesive system for attaching an optical sensor-transmitter system. Methods and systems are also disclosed for a sensor inserter system. The inserter can include a lancet tip that includes a convex feature attached to a first surface of the lancet tip.
A61B 5/1455 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value using optical sensors, e.g. spectral photometrical oximeters
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
A61B 5/1459 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value using optical sensors, e.g. spectral photometrical oximeters invasive, e.g. introduced into the body by a catheter
A61B 5/1486 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value using chemical or electrochemical methods, e.g. by polarographic means using enzyme electrodes, e.g. with immobilised oxidase
Provided herein is a stabilized oxygen transport matrix that includes a reversible oxygen binding protein, such as hemoglobin, immobilized throughout the stabilized oxygen transport matrix. The stabilized oxygen transport matrix is used to transport oxygen and can be used as an oxygen transport region and a reaction region of an analyte sensor, such as an implantable glucose sensor. The reversible binding protein can also function as an oxygen probe within the analyte sensor.
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
G01F 1/64 - Measuring the volume flow or mass flow of fluid or fluent solid material wherein the fluid passes through a meter in a continuous flow by using electric or magnetic effects by measuring electrical currents passing through the fluid flowMeasuring the volume flow or mass flow of fluid or fluent solid material wherein the fluid passes through a meter in a continuous flow by using electric or magnetic effects by measuring electrical potential generated by the fluid flow, e.g. by electrochemical, contact, or friction effects
C12Q 1/00 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions
C12Q 1/54 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving glucose or galactose
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value
A61B 5/1486 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value using chemical or electrochemical methods, e.g. by polarographic means using enzyme electrodes, e.g. with immobilised oxidase
A61B 5/1459 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value using optical sensors, e.g. spectral photometrical oximeters invasive, e.g. introduced into the body by a catheter
A61B 5/1473 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value using chemical or electrochemical methods, e.g. by polarographic means invasive, e.g. introduced into the body by a catheter
Provided herein is a stabilized oxygen transport matrix that includes a reversible oxygen binding protein, such as hemoglobin, immobilized throughout the stabilized oxygen transport matrix. The stabilized oxygen transport matrix is used to transport oxygen and can be used as an oxygen transport region and a reaction region of an analyte sensor, such as an implantable glucose sensor. The reversible binding protein can also function as an oxygen probe within the analyte sensor.
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
G01F 1/64 - Measuring the volume flow or mass flow of fluid or fluent solid material wherein the fluid passes through a meter in a continuous flow by using electric or magnetic effects by measuring electrical currents passing through the fluid flowMeasuring the volume flow or mass flow of fluid or fluent solid material wherein the fluid passes through a meter in a continuous flow by using electric or magnetic effects by measuring electrical potential generated by the fluid flow, e.g. by electrochemical, contact, or friction effects
C12Q 1/00 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions
C12Q 1/54 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving glucose or galactose
patents
