# US 11,026,605 B1 · Analyte sensor > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,026,605 B1 - Document ID: US11026605B1 - Status: Granted - Kind: B1 - Application number: 17/161,421 - Filed: 2021-01-28 - Published: 2021-05-20 - Granted: 2021-06-08 - Earliest claimed: 2006-02-22 - Assignees: DexCom, Inc. - Applicants: DexCom, Inc. - Inventors: Peter C. Simpson; James H. Brauker; Mark C. Brister; Paul V. Goode, Jr.; Victor Ha; Apurv Ullas Kamath; Aarthi Mahalingam; Steve Masterson; Melissa A. Nicholas; John Nolting; James R. Petisce; Jack Pryor; Sean Saint; Vance Swanson; Matthew D. Wightlin; Kum Ming Woo - Web page: https://patentgrep.com/patent/US11026605B1 ## CPC - A61B 5/14532: {for measuring glucose, e.g. by tissue impedance measurement} - A61B 5/0002: {Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network (endoradiosondes A61B5/07)} - A61B 5/0004: {characterised by the type of physiological signal transmitted} - A61B 5/0031: {Implanted circuitry} - A61B 5/05: Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves (measuring movement of the entire body or parts thereof A61B5/11; detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof A61B5/24) - A61B 5/1411: {by percutaneous method, e.g. by lancet} - A61B 5/14503: {invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors (A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence)} - A61B 5/14507: {specially adapted for measuring characteristics of body fluids other than blood (devices for taking samples of body liquids A61B10/0045)} - A61B 5/1451: {for interstitial fluid} - A61B 5/14514: {using means for aiding extraction of interstitial fluid, e.g. microneedles or suction} - A61B 5/14546: {for measuring analytes not otherwise provided for, e.g. ions, cytochromes} - A61B 5/1473: invasive, e.g. introduced into the body by a catheter - A61B 5/14735: {comprising an immobilised reagent} - A61B 5/1486: using enzyme electrodes, e.g. with immobilised oxidase - A61B 5/14865: {invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors} - A61B 5/1495: Calibrating or testing of in-vivo probes - A61B 5/6801: {specially adapted to be attached to or worn on the body surface} - A61B 5/6833: {Adhesive patches} - A61B 5/68335: {including release sheets or liners} - A61B 5/6848: {Needles} - A61B 5/6849: {in combination with a needle set} - A61B 5/72: {Signal processing specially adapted for physiological signals or for diagnostic purposes} - A61B 17/3468: {for implanting or removing devices, e.g. prostheses, implants, seeds, wires (devices for implanting seeds A61M37/0069)} - A61B 5/14: {Devices for taking samples of blood (hypodermic syringes A61M5/00); Measuring characteristics of blood in vivo, e.g. gas concentration within the blood, pH-value of blood (measuring of blood pressure A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06)} - A61B 5/145: Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value {; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue} (non-radiation detecting or locating of foreign bodies in blood A61B5/06) - A61B 5/1468: using chemical or electrochemical methods, e.g. by polarographic means - A61B 5/150022: {for capillary blood or interstitial fluid} - A61B 2017/3492: {against the outside of the body} - A61B 2560/0223: of calibration, e.g. protocols for calibrating sensors - A61B 2560/045: with a separable interface unit, e.g. for communication - A61B 2560/063: Devices specially adapted for delivering implantable medical measuring apparatus - A61B 2562/18: Shielding or protection of sensors from environmental influences, e.g. protection from mechanical damage - A61M 5/14244: {adapted to be carried by the patient, e.g. portable on the body} - A61M 5/1723: {using feedback of body parameters, e.g. blood sugar or pressure} - A61M 2005/1585: {Needle inserters} - Y02A 90/10: Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} - Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE ## Abstract The present invention relates generally to systems and methods for measuring an analyte in a host. More particularly, the present invention relates to systems and methods for transcutaneous measurement of glucose in a host. ## Claims ### Claim 1 A glucose monitoring system comprising: a first component comprising: a transcutaneous glucose sensor configured for transcutaneous implantation into a body of a host, the transcutaneous glucose sensor comprising: an electrode; and a membrane comprising at least one enzyme; an electrical contact comprising a material associated with a first durometer hardness; and a sealing member at least partially surrounding a portion of the transcutaneous glucose sensor and at least partially surrounding the elastomeric electrical contact, the elastomeric sealing member comprising a material associated with a second durometer hardness that is less than the first durometer hardness; and a second component comprising sensor electronics operably connectable to the transcutaneous glucose sensor; wherein the first component is sterilized with radiation sterilization by exposing the transcutaneous glucose sensor to an electron beam radiation at a dose of from 12 kGy to 50 kGy. ### Claim 2 (depends on 1) The glucose monitoring system of claim 1, wherein the dose is about 25 kGy. ### Claim 3 (depends on 1) The glucose monitoring system of claim 1, wherein the membrane is a membrane system comprising a plurality of different membrane layers. ### Claim 4 (depends on 1) The glucose monitoring system of claim 1, wherein the membrane is a membrane layer. ### Claim 5 (depends on 1) The glucose monitoring system of claim 1, wherein the membrane has a thickness from 20 microns to 55 microns. ### Claim 6 (depends on 5) The glucose monitoring system of claim 5, wherein the dose is about 25 kGy. ### Claim 7 (depends on 5) The glucose monitoring system of claim 5, wherein the membrane is a membrane system comprising a plurality of different membrane layers. ### Claim 8 (depends on 5) The glucose monitoring system of claim 5, wherein the membrane is a membrane layer. ### Claim 9 A glucose monitoring system comprising: a first component comprising: a transcutaneous glucose sensor configured for transcutaneous implantation into a body of a host, the transcutaneous glucose sensor comprising: an electrode; and a membrane comprising at least one enzyme; an electrical contact comprising a material associated with a first durometer hardness; and a sealing member at least partially surrounding a portion of the transcutaneous glucose sensor and at least partially surrounding the elastomeric electrical contact, the elastomeric sealing member comprising a material associated with a second durometer hardness that is less than the first durometer hardness; and a second component comprising sensor electronics operably connectable to the transcutaneous glucose sensor, wherein the sensor electronics are not radiation sterilized, wherein the second component and the first component are configured to be physically coupled during sensor use; wherein the first component is sterilized with radiation sterilization by exposing the transcutaneous glucose sensor to an electron beam radiation at a dose of from 12 kGy to 50 kGy. ### Claim 10 (depends on 9) The glucose monitoring system of claim 9, wherein the dose is about 25 kGy. ### Claim 11 (depends on 9) The glucose monitoring system of claim 9, wherein the membrane is a membrane system comprising a plurality of different membrane layers. ### Claim 12 (depends on 9) The glucose monitoring system of claim 9, wherein the membrane is a membrane layer. ### Claim 13 (depends on 9) The glucose monitoring system of claim 9, wherein the membrane has a thickness from 20 microns to 55 microns. ### Claim 14 (depends on 13) The glucose monitoring system of claim 13, wherein the dose is about 25 kGy. ### Claim 15 (depends on 13) The glucose monitoring system of claim 13, wherein the membrane is a membrane system comprising a plurality of different membrane layers. ### Claim 16 (depends on 13) The glucose monitoring system of claim 13, wherein the membrane is a membrane layer. ### Claim 17 A method of making a glucose concentration measuring system comprising: manufacturing at least one transcutaneous glucose sensor, wherein the at least one transcutaneous glucose sensor comprises: an in vivo portion configured for insertion into a body of a host during sensor use; and an ex vivo portion configured to remain outside the body of the host during sensor use; measuring a glucose sensitivity characteristic associated with the at least one transcutaneous glucose sensor; assigning information associated with a sensor sensitivity to the at least one transcutaneous glucose sensor based at least in part on the glucose sensitivity characteristic measurement; storing the information associated with the sensor sensitivity in sensor electronics; configuring a processor to use the information associated with the sensor sensitivity to calibrate sensor data derived from the at least one transcutaneous glucose sensor after implantation of the in vivo portion of the at least one transcutaneous glucose sensor into the body of the host, without use of a reference glucose concentration value obtained after implantation of the in vivo portion of the at least one transcutaneous glucose sensor into the body of the host; and sterilizing the at least one transcutaneous glucose sensor by exposing the at least one transcutaneous glucose sensor to an electron beam radiation at a dose of from 12 kGy to 50 kGy. ### Claim 18 (depends on 17) The method of claim 17, wherein the dose is about 25 kGy. ### Claim 19 (depends on 17) The method of claim 17, wherein the processor is incorporated in a receiver. ### Claim 20 (depends on 19) The method of claim 19, wherein the receiver comprises a display screen. ### Claim 21 (depends on 17) The method of claim 17, wherein the processor is incorporated in the sensor electronics. ### Claim 22 (depends on 17) The method of claim 17, the sensor electronics are not sterilized with radiation. ### Claim 23 (depends on 18) The method of claim 18, wherein the sensor data is derived from a signal received from the at least one transcutaneous glucose sensor. ### Claim 24 (depends on 17) The method of claim 17, wherein the glucose sensitivity characteristic is derived from in vitro testing of other transcutaneous glucose sensors. ### Claim 25 A method of making a glucose concentration measuring system comprising: manufacturing at least one transcutaneous glucose sensor, wherein the at least one transcutaneous glucose sensor comprises: an in vivo portion configured for insertion into a body of a host during sensor use; and an ex vivo portion configured to remain outside the body of the host during sensor use; measuring a glucose sensitivity characteristic associated with the at least one transcutaneous glucose sensor; assigning information associated with a sensor sensitivity to the at least one transcutaneous glucose sensor based at least in part on the glucose sensitivity characteristic measurement; storing the information associated with the sensor sensitivity in sensor electronics; configuring a processor to use the information associated with the sensor sensitivity to calibrate sensor data derived from the at least one transcutaneous glucose sensor after implantation of the in vivo portion of the at least one transcutaneous glucose sensor into the body of the host, without use of a reference glucose concentration value obtained after implantation of the in vivo portion of the at least one transcutaneous glucose sensor into the body of the host; sterilizing the at least one transcutaneous glucose sensor by exposing the at least one transcutaneous glucose sensor to an electron beam; and sterilizing the sensor electronics by exposing the sensor electronics to a gas. ### Claim 26 (depends on 25) The method of claim 25, wherein the processor is incorporated in a receiver. ### Claim 27 (depends on 25) The method of claim 25, wherein the processor is incorporated in the sensor electronics. ### Claim 28 (depends on 25) The method of claim 25, wherein the gas is ethylene oxide. ### Claim 29 (depends on 25) The method of claim 25, wherein the sensor data is derived from a signal received from the at least one transcutaneous glucose sensor. ### Claim 30 (depends on 25) The method of claim 25, wherein the glucose sensitivity characteristic is derived at least in part from in vitro testing of other transcutaneous glucose sensors.