Dexcom, Inc.

Depuy Mitek, Inc.

Zense-life Inc.

Allez Health Inc.

Other

Ethicon, Gmbh

Depuy Synthes Products, Inc.

Warsaw Orthopedic, Inc.

Robert James Boock

Peter C Simpson

Matthew D Wightlin

Michael J Estes

Huashi Zhang

Monica A Rixman

Apurv Ullas Kamath

Jack Pryor

Paul V Neale

Sebastian Bohm

Kristina Lawrence

James H Brauker

Mark C Brister

Chris W Dring

Kum Ming Woo

Melissa A Nicholas

James R Petisce

Mark C Shults

Nathan Stewart Cauldwell

Jeff Jackson

Monica Rixman Swinney

Eli Reihman

Mark Allan Tapsak

Antonio C Llevares

David Price

Kaushik Aroonkumar Patel

Jason Mitchell

Mark Wu

Dubravka Markovic

Jonathan Hughes

Seth R Brunner

Lisa Nguyen

Arthur Chee

David Sze

Paul V Goode, Jr

Michael Robert Mensinger

Hari Hampapuram

Leif N Bowman

Jacob S Leach

Phil Mayou

Jennifer Blackwell

Richard Chien Yang

Sebastian Böhm

Keith M Orr

John Burd

Katherine Yerre Koehler

Kristian J DiMatteo

Kevin J Ranucci

Naresh Chandra Bhavaraju

Daiting Rong

Andrew Attila Pal

Laura J Dunn

David DeRenzy

Matthew Lawrence Johnson

Jeff T Suri

Kostyantyn Snisarenko

Rathburn K Rhodes

Shelby L Cook

Jessie Haskamp

Qinyi Yan

Robert S Pesce

Keri Weindel

Aarthi Mahalingam

Victoria E Carr-Brendel

Rathbun K Rhodes

Ying Li

Sridevi N Dhanaraj

Ted Tang Lee

Mohammad Ali Shariati

Stephanie M Kladakis

Shanger Wang

Victor Ha

Jiong Zou

Keri Leone

Jill Mari Embry

Andrew Trinin Dennis

Kostantyn Snisarenko

Paul Smith

Jocelyn Lo

Wei Gu

Michael Christophe Walsh

Khyati Mehta

Brendan Mccarthy

Described here are embodiments of processes and systems for the continuous manufacturing of implantable continuous analyte sensors. In some embodiments, a method is provided for sequentially advancing an elongated conductive body through a plurality of stations, each configured to treat the elongated conductive body. In some of these embodiments, one or more of the stations is configured to coat the elongated conductive body using a meniscus coating process, whereby a solution formed of a polymer and a solvent is prepared, the solution is continuously circulated to provide a meniscus on a top portion of a vessel holding the solution, and the elongated conductive body is advanced through the meniscus. The method may also comprise the step of removing excess coating material from the elongated conductive body by advancing the elongated conductive body through a die orifice. For example, a provided elongated conductive bodyis advanced through a pre-coating treatment station, through a coating station, through a thickness control station, through a drying or curing station, through a thickness measurement station, and through a post-coating treatment station

Continuous analyte sensors and methods of making same

A working wire for a biological sensor is disclosed. The working wire includes a substrate comprising cobalt-chromium (Co—Cr) alloy or Nitinol alloy, a platinum layer comprising platinum on the substrate, and a membrane layer comprising a biological membrane applied over the platinum layer.

Working wire for a biological sensor

In some embodiments, a method of manufacturing a metabolic sensor includes assembling a working wire for a metabolic sensor and exposing the interference layer to an oxidizing agent such as a gas. The assembly comprises forming an interference layer on a substrate, the substrate having an electrically conductive surface; forming an enzyme layer on the interference layer; and forming a glucose limiting layer on the enzyme layer. The exposing is performed prior to sterilizing the working wire.

Method of manufacturing a metabolic sensor

A subcutaneous sensor for use with a continuous glucose monitor includes a working electrode and a reference electrode. The reference electrode comprises a reference substrate, an ion limiting layer over the reference substrate and a composition for releasing nitric oxide (NO). The composition has a NO release compound, a hydrophilic material and a hydrophobic material. A subcutaneous sensor for use with a continuous glucose monitor includes a reference electrode comprising a composition for releasing nitric oxide (NO). The composition has a NO release compound, a hydrophilic material and a hydrophobic material. The reference electrode is positioned separate from a working electrode.

Sensor for a continuous biological monitor having nitric oxide releasing compound

A working electrode for a subcutaneous sensor for use with a continuous biological monitor for a patient is disclosed. The working electrode includes a conductive substrate and an enzyme layer on the conductive substrate. The enzyme layer includes an enzyme, and the enzyme selected according to a biological function to be monitored. A hydrophobic material cross-linked with an acrylic polyol is included. The enzyme is fully entrapped in the cross-linked hydrophobic material with the acrylic polyol.

Working electrode of a continuous biological sensor

Devices are provided for measurement of an analyte concentration, e.g., glucose in a host. The device can include a sensor configured to generate a signal associated with a concentration of an analyte; and a sensing membrane located over the sensor. The sensing membrane comprises a diffusion resistance domain configured to control a flux of the analyte therethrough. The diffusion resistance domain comprises one or more zwitterionic compounds and a base polymer comprising both hydrophilic and hydrophobic regions.

Zwitterion surface modifications for continuous sensors

Analyte sensors and methods of manufacturing same are provided, including analyte sensors comprising multi-axis flexibility. For example, a multi-electrode sensor systemcomprising two working electrodes and at least one reference/counter electrode is provided. The sensor systemcomprises first and second elongated bodies E, E, each formed of a conductive core or of a core with a conductive layer deposited thereon, insulating layerthat separates the conductive layerfrom the elongated body, a membrane layer deposited on top of the elongated bodies E, E, and working electrodes″ formed by removing portions of the conductive layerand the insulating layer, thereby exposing electroactive surface of the elongated bodies E, E

Analyte sensors and methods of manufacturing same

A working electrode for a subcutaneous sensor for use with a continuous biological monitor for a patient is disclosed. The working electrode includes a conductive substrate and a carbon-enzyme layer on the conductive substrate. The carbon-enzyme layer includes a polyurethane or silicone crosslinked with an acrylic polyol, and an enzyme fully entrapped by the polyurethane or silicone crosslinked with the acrylic polyol. The enzyme is selected according to a biological function to be monitored. The carbon-enzyme layer also includes a carbon material. The carbon-enzyme layer is electrically conductive and facilitates a generation of either peroxide or electrons within the carbon-enzyme layer responsive to reacting the enzyme with a target biologic from blood of the patient.

Methods for coating a working wire for a continuous biological sensor include providing a plurality of wires in a fixture and dipping the plurality of wires into a coating solution according to parameters for a dipping process. A plurality of diameters is measured along a length of at least two coated wires of the plurality of wires in the fixture, using an automated measurement system, as in an in-line process. A controller that is in communication with the automated measurement system determines a thickness difference, the thickness difference being a difference between a thickness setpoint and an aggregate criteria for the plurality of diameters. The controller calculates adjusted parameters for the dipping process based on the thickness difference.

Coating a working wire for a continuous biological sensor

Devices and methods are provided for continuous measurement of an analyte concentration. The device can include a sensor having a plurality of sensor elements, each having at least one characteristic that is different from other sensor(s) of the device. In some embodiments, the plurality of sensor elements are each tuned to measure a different range of analyte concentration, thereby providing the device with the capability of achieving a substantially consistent level of measurement accuracy across a physiologically relevant range. In other embodiments, the device includes a plurality of sensor elements each tuned to measure during different time periods after insertion or implantation, thereby providing the sensor with the capability to continuously and accurately measure analyte concentrations across a wide range of time periods. For example, a sensor systemis provided having a first working electrodecomprising a first sensor elementand a second working electrodecomprising a second sensor elementand a reference electrodefor providing a reference value for measuring the working electrode potential of the sensor elements

Analyte sensor

Devices are presented for measurement of an analyte concentration. The devices comprise: a sensor configured to generate a signal indicative of a concentration of an analyte; and a sensing membrane located over the sensor. The sensing membrane comprises an enzyme domain comprising an enzyme, a base polymer, and a hydrophilic polymer which makes up from about 5 wt. % to about 30 wt. % of the enzyme domain.

Membrane for continuous analyte sensors

A transcutaneous sensor device configured for continuously measuring analyte concentrations in a host is provided. In some embodiments, the transcutaneous sensor devicecomprises an in vivo portionconfigured for insertion under the skinof the host and an ex vivo portionconfigured to remain above the surface of the skinof the host after sensor insertion of the in vivo portion. The in vivo portion may comprise a tissue piercing elementconfigured for piercing the skinof the host and a sensor bodycomprising a material or support memberthat provides sufficient column strength to allow the sensor body to be pushable in a host tissue without substantial buckling. The ex vivo portionmay be configured to comprise (or operably connect to) a sensor electronics unit and may comprise a mounting unit. Also described here are various configurations of the sensor body and the tissue piercing element that may be used to protect the membrane of the sensor body.

Transcutaneous analyte sensor

Systems and methods of use involving sensors having a particle-containing domain are provided for continuous analyte measurement in a host. In some embodiments, a continuous analyte measurement system is configured to be wholly, transcutaneously, intravascularly or extracorporeally implanted.

Particle-containing membrane and particulate electrode for analyte sensors

Systems and methods for compensating for effects of temperature on implantable sensors are provided. In some embodiments, systems and methods are provided for measuring a temperature to determine a change in temperature in a sensor environment. In certain embodiments, a temperature compensation factor is determined based on a change in temperature of the sensor environment. The temperature compensation factor can be used in processing raw data of an analyte signal to report a more accurate analyte concentration.

Devices, systems, and methods to compensate for effects of temperature on implantable sensors

Growing community of inventors

Carlsbad, CA, United States of America

Robert James Boock