# US 11,998,369 B2 · Packaging for medical devices coated with perfluorinated liquids or dispersions thereof > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,998,369 B2 - Document ID: US11998369B2 - Status: Granted - Kind: B2 - Application number: 17/228,474 - Filed: 2021-04-12 - Published: 2021-12-02 - Granted: 2024-06-04 - Earliest claimed: 2018-10-11 - Assignees: Freeflow Medical Devices LLC - Applicants: Freeflow Medical Devices LLC - Inventors: Saibal Bandyopadhyay; Andrew K. Jones - Web page: https://patentgrep.com/patent/US11998369B2 ## CPC - 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) - A61M 25/002: {Packages specially adapted therefor (combined with means for introducing catheters, e.g. dispensers, A61M25/0113); catheter kit packages (for surgical articles A61B50/30)} - A61F 2/0095: {Packages or dispensers for prostheses or other implants (for intraocular lenses A61F2/1691; for dental surgery A61C19/02)} - A61L 2/206: Ethylene oxide - A61L 29/085: {Macromolecular materials} - A61L 33/064: {obtained by reactions only involving carbon-to-carbon unsaturated bonds (A61L33/062 takes precedence)} - A61B 5/00: Measuring for diagnostic purposes (radiation diagnosis A61B6/00; diagnosis by ultrasonic, sonic or infrasonic waves A61B8/00); Identification of persons - A61B 2050/005: {with a lid or cover} - A61B 2562/242: Packaging, i.e. for packaging the sensor or apparatus before use - A61L 2103/15: Laboratory, medical or dentistry appliances, e.g. catheters or sharps - A61L 2202/181: Flexible packaging means, e.g. permeable membranes, paper - 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)} - A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C) - 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) ## Abstract The present disclosure includes and provides for methods of packaging medical devices that are to be treated with a fluorinated liquid to alter their surface properties, packaging systems for such medical devices, and methods of utilizing the packaging systems to treat the medical devices. The packaging systems permit effective storage and distribution of medical devices that upon contact with mammalian blood have limited thrombogenicity or are non-thrombogenic and/or are resistant to adhesion of blood cells or clots. ## Claims ### Claim 1 A medical device packaging system comprising: (i) a base having a channel substantially conforming to the shape of a medical device, the channel having a volume; (ii) a cover forming a substantially gas and liquid tight seal over the channel, wherein the cover can be peeled away from the base exposing all or part of the channel; and (iii) a medical device disposed in the channel, the medical device comprising a fluoropolymer and/or perfluoropolymer component or coating on all or part of its surface; wherein the medical device comprises a connector to the medical device that is also disposed in the channel; wherein the medical device comprises a fluoropolymer and/or perfluoropolymer; and wherein the medical device further comprises a fluorinated liquid which comprises or is one or more perfluorinated liquids. ### Claim 2 (depends on 1) The packaging system of claim 1, wherein the base is made by additive manufacturing, casting, injection molding, stamping, or pressing. ### Claim 3 (depends on 1) The packaging system of claim 1, wherein the base is made from polymeric material. ### Claim 4 (depends on 3) The packaging system of claim 3, wherein the polymeric material is selected from the group consisting of: low density polyethylene, high density polyethylene, polypropylene, polyethylene terephthalate, polyvinyl chloride fluoropolymers, perfluoropolymers, and combinations thereof. ### Claim 5 (depends on 1) The packaging system of claim 1, wherein the channel has a volume less than 300% of the volume of the medical device. ### Claim 6 (depends on 1) The packaging system of claim 1, wherein the base has a substantially planar surface and one or more sides abutting the substantially planar surface; and wherein the channel is formed in the substantially planar surface and extends to at least one of the one or more sides and is exposed to and/or accessible on at least one of the one or more sides of the base; and wherein at least an end of the medical device disposed in the channel, or the connector to the medical device disposed in the channel, is exposed to and/or accessible on at least one side of the one or more sides of the base. ### Claim 7 (depends on 1) The packaging system of any of claim 1, wherein the medical device comprises a tubular structure having an inner lumen and/or an internal space. ### Claim 8 (depends on 7) The packaging system of claim 7, wherein the connector to the medical device is in fluid communication with the inner lumen and/or the internal space of the medical device. ### Claim 9 (depends on 8) The packaging system of claim 8, wherein the connector comprises one or more luer fittings. ### Claim 10 (depends on 6) The packaging system of claim 6, wherein the cover is affixed to the substantially planar surface and forms a substantially gas and liquid tight seal over the part of the channel formed in the substantially planar surface and the portion of the channel exposed to or accessible on the one or more sides of the base; and wherein the cover has a tab along or at an edge to assist in its separation from the base. ### Claim 11 (depends on 10) The packaging system of claim 10, wherein the cover may be removed from a side of the base to expose a portion of the channel, the medical device, and/or a connector attached to the medical device. ### Claim 12 (depends on 1) The packaging system of claim 1, wherein all or part of the cover is permeable to ethylene oxide and permits ethylene oxide to reach the medical device. ### Claim 13 (depends on 1) The packaging system of claim 1, wherein the fluoropolymers and/or perfluoropolymers are selected from the group consisting of: perfluoroalkoxy alkanes; polytetrafluoroethylene; fluorinated ethylene propylene; expanded polytetrafluoroethylene; expanded fluorinated ethylene propylene; perfluoromethylvinylether; perfluoro elastomers; ethylene tetrafluoroethylene; polyvinylidene fluoride; fluoroelastomers; vinylidene fluoride-hexafluoropropylene fluoroelastomer; vinylidene fluoride-hexafluoropropylene/tetrafluoro ethylene/hexafluoropropylene fluoroelastomer terpolymer; and combinations thereof. ### Claim 14 (depends on 1) The packaging system of claim 1, wherein the fluorinated liquid is a fluorinated alkane or a perfluorinated alkane. ### Claim 15 (depends on 1) The packaging system of claim 1, wherein the fluorinated liquid includes one or more solvents selected from: perfluoropropane, perfluorobutane, perfluoropentane, perfluorohexane, perfluorooctane, perfluorodecalin, perfluoroperhydrophenanthrene, perfluorooctylbromide, perfluoro tributyl amine, perfluorotripentyl amine, poly(hexafluoropropylene oxide) and combinations thereof. ### Claim 16 (depends on 1) The packaging system of claim 1, wherein the fluorinated liquid is contained in a reservoir separately from the channel. ### Claim 17 (depends on 16) The packaging system of claim 16, wherein the fluorinated liquid is contained in a syringe, bottle, or flexible bag/pouch. ### Claim 18 (depends on 16) The packaging system of claim 16, wherein the reservoir is comprised of a polymer, ceramic, glass, metal, silicone or combinations thereof. ### Claim 19 (depends on 16) The packaging system of claim 16, wherein the channel and the medical device disposed therein are sterile. ### Claim 20 (depends on 1) A method for treating a medical device with a fluorinated liquid comprising obtaining a medical device packaging system according to claim 1 and introducing the fluorinated liquid into the channel, wherein the channel has a volume.