# US 11,305,906 B2 · Method of packaging analyte sensors > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,305,906 B2 - Document ID: US11305906B2 - Status: Granted - Kind: B2 - Application number: 16/013,777 - Filed: 2018-06-20 - Published: 2018-10-18 - Granted: 2022-04-19 - Earliest claimed: 2014-02-11 - Assignees: DexCom, Inc. - Applicants: DexCom, Inc. - Inventors: Minda McDorman Grucela; Jinsong Gao - Web page: https://patentgrep.com/patent/US11305906B2 ## CPC - B65B 55/02: Sterilising, e.g. of complete packages - A61B 5/14532: {for measuring glucose, e.g. by tissue impedance measurement} - A61B 5/150022: {for capillary blood or interstitial fluid} - A61B 5/150305: {Packages specially adapted for piercing devices or blood sampling devices} - A61B 5/15087: {short range, e.g. between console and disposable (using implanted devices A61B5/150877)} - A61B 50/20: Holders specially adapted for surgical or diagnostic appliances or instruments (drapes with means to hold surgical instruments A61B46/23; for catheters A61M25/02) - A61B 50/30: Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments (for wound clamps A61B17/10; for ligaturing clips A61B17/122; packages or dispensers for surgical gloves or finger-stalls A61B42/40) - A61B 50/33: Trays - A61L 2/08: Radiation - A61L 2/087: Particle radiation, e.g. electron-beam, alpha or beta radiation - A61L 2/20: Gaseous substances, e.g. vapours - A61L 2/26: Accessories - A61M 5/003: {Kits for diabetics} - B65B 55/10: by liquids or gases - B65B 55/18: by liquids or gases (B65B55/14 takes precedence) - A61B 2050/0057: {about a transverse axis in the lid plane} - A61B 2050/0065: {Peelable cover} - A61B 2050/3008: {having multiple compartments} - A61B 2560/04: Constructional details of apparatus - A61L 2103/15: Laboratory, medical or dentistry appliances, e.g. catheters or sharps - A61M 5/3287: {Accessories for bringing the needle into the body; Automatic needle insertion (A61M5/20, A61M5/31525 take precedence)} - A61M 2205/33: Controlling, regulating or measuring - A61M 2205/3553: remote, e.g. between patient's home and doctor's office - A61M 2205/3561: local, e.g. within room or hospital - A61M 2205/3576: with non implanted data transmission devices, e.g. using external transmitter or receiver - A61M 2205/50: with microprocessors or computers - B65B: MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING (bundling and pressing devices for cigars A24C1/44; devices for tensioning and securing binders adapted to be supported by the article or articles to be bound B25B25/00; applying closure members to bottles, jars or similar containers B67B1/00-B67B6/00; concurrent cleaning, filling and closing of bottles B67C7/00; emptying bottles, jars, cans, casks, barrels or similar containers B67C9/00) - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K) - 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)} ## Abstract A system and method are provided for packaging and sterilizing analyte sensors. The packaging system provides a structure for securing the analyte sensors in a fixed position and fixed orientation within the package. ## Claims ### Claim 1 A method for packaging a product, the method comprising: securing a plurality of products in a fixed position and fixed orientation within a respective plurality of first containers, wherein each of the products comprises a transcutaneous glucose sensor and an adhesive patch for the transcutaneous glucose sensor with a bottom side, wherein the bottom side of the adhesive patch is spaced apart from all other objects within the first container to avoid contact between the bottom side of the adhesive patch and the other objects, and wherein each first container is configured to be permeable to gas; securing the plurality of first containers in a fixed position and fixed orientation within a second container such that movement of the second container does not result in substantial movement or orientation change of the plurality of first containers within the second container; displacing ambient air from the plurality of products by exposing the plurality of products to an inert gas; and sterilizing the transcutaneous glucose sensor of each of the plurality of products by exposing the transcutaneous glucose sensor of each of the plurality of products to a sterilant gas while the plurality of products are secured in the fixed position and fixed orientation within the respective plurality of first containers. ### Claim 2 (depends on 1) The method of claim 1, wherein the sterilant gas is ethylene oxide. ### Claim 3 (depends on 1) The method of claim 1, wherein securing the plurality of products is performed by securing each product in one of the plurality of first containers and attaching a backing layer to each first container. ### Claim 4 (depends on 3) The method of claim 3, wherein each first container is a molded part with a chamber for receiving one of the products. ### Claim 5 (depends on 3) The method of claim 3, wherein the backing layer comprises polyethylene. ### Claim 6 (depends on 3) The method of claim 3, wherein the backing layer is permeable to gas. ### Claim 7 (depends on 3) The method of claim 3, wherein the backing layer comprises a polymer selected from the group consisting of: polyvinyl chloride, polyethylene, polyethylene terephthalate, polyethylene terephthalate glycol, polyvinylidene chloride, polypropylene, polyethylene, styrene, and copolymers thereof. ### Claim 8 (depends on 1) The method of claim 1, wherein each product comprises an on-skin assembly including an on-skin electronics housing configured to house electronics for the transcutaneous glucose sensor, each on-skin assembly including the adhesive patch configured to adhere to a host's skin and having a top side coupled to the on-skin electronics housing. ### Claim 9 (depends on 8) The method of claim 8, wherein each product comprises an insertion device to insert the transcutaneous glucose sensor into the host's skin. ### Claim 10 (depends on 1) The method of claim 1, wherein each transcutaneous glucose sensor comprises an electrode surrounded by a membrane configured to be exposed to interstitial fluid. ### Claim 11 (depends on 1) The method of claim 1, wherein securing the plurality of first containers in a fixed position and fixed orientation within the second container is performed by aligning and affixing a region of each first container to a retainer. ### Claim 12 (depends on 11) The method of claim 11, wherein the retainer comprises an aperture or pocket shaped to receive and conform to the region of the first container. ### Claim 13 (depends on 1) The method of claim 1, further comprising a third container, wherein the third container is dimensioned and configured to receive a plurality of second containers and secure the plurality of second containers in a fixed position and fixed orientation. ### Claim 14 A method for packaging a product, the method comprising: securing the product in a fixed position and fixed orientation within a first container, wherein the product comprises a transcutaneous glucose sensor and an adhesive patch for the transcutaneous glucose sensor with a bottom side, wherein the bottom side of the adhesive patch is spaced apart from all other objects within the first container to avoid contact between the bottom side of the adhesive patch and the other objects, and wherein the first container is configured to be permeable to gas; securing the first container in a fixed position and fixed orientation within a second container such that movement of the second container does not result in substantial movement or orientation change of the first container within the second container; displacing ambient air from the product by exposing the product to an inert gas; and sterilizing the transcutaneous glucose sensor of the product by exposing the transcutaneous glucose sensor of the product to a sterilant gas while the product is secured in the fixed position and fixed orientation within the first container. ### Claim 15 (depends on 14) The method of claim 14, wherein the sterilant gas is ethylene oxide. ### Claim 16 (depends on 14) The method of claim 14, wherein securing the product is performed by securing the product in the first container and attaching a backing layer to the first container. ### Claim 17 (depends on 16) The method of claim 16, wherein the first container is a molded part with a chamber for receiving the product. ### Claim 18 (depends on 16) The method of claim 16, wherein the backing layer is permeable to gas. ### Claim 19 (depends on 14) The method of claim 14, wherein each product comprises an insertion device to insert the transcutaneous glucose sensor into a host's skin, and an on-skin assembly including an on-skin electronics housing configured to house electronics for the transcutaneous glucose sensor, each on-skin assembly including the adhesive patch configured to adhere to the host's skin and having a top side coupled to the on-skin electronics housing. ### Claim 20 (depends on 14) The method of claim 14, further comprising a third container, wherein the third container is dimensioned and configured to receive a plurality of second containers and secure the plurality of second containers in a fixed position and fixed orientation.