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WO 2014/031398 Al 27 February 2014 (27.02.2014) P O P C T

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WO 2014/031398 Al 27 February 2014 (27.02.2014) P O P C T (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date WO 2014/031398 Al 27 February 2014 (27.02.2014) P O P C T (51) International Patent Classification: DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, A61L 33/06 (2006.01) A61M 25/01 (2006.01) HN, HR, HU, ID, IL, IN, IS, JP, KE, KG, KN, KP, KR, A61L 27/14 (2006.01) A61F 2/82 (2006.01) KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, (21) International Application Number: OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, PCT/US20 13/054841 SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, (22) International Filing Date: TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, 14 August 2013 (14.08.2013) ZW. (25) Filing Language: English (84) Designated States (unless otherwise indicated, for every kind of regional protection available): ARIPO (BW, GH, (26) Publication Language: English GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, SZ, TZ, (30) Priority Data: UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, TJ, 61/684,947 20 August 2012 (20.08.2012) US TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK, 61/787,237 15 March 2013 (15.03.2013) US EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, (71) Applicant: TICONA LLC [US/US]; 8040 Dixie High TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, way, Florence, KY 41042 (US). KM, ML, MR, NE, SN, TD, TG). (72) Inventors: HUFEN, Julia; Wallacher Str. 54, 47495 Declarations under Rule 4.17 : Rheinberg (DE). VERROCCHI, Anthony; 1260 Upland — as to applicant's entitlement to apply for and be granted a Avenue Unit #2, Covington, KY 4101 1 (US). WALKEN- patent (Rule 4.1 7(H)) HORST, Rainer; Meissheideweg 20, 45328 Melle (DE). — as to the applicant's entitlement to claim the priority of the (74) Agents: JOHNSTON, Jason W. et al; Dority & Manning, earlier application (Rule 4.1 7(in)) PA, PO Box 1449, Greenville, South Caroline 29602 (US). Published: (81) Designated States (unless otherwise indicated, for every kind of national protection available): AE, AG, AL, AM, — with international search report (Art. 21(3)) AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, 00 o o (54) Title: BIOMEDICAL DEVICES COMPRISING MOLDED POLYETHYLENE COMPONENTS (57) Abstract: A molded polyethylene component that comprises polyethylene having a melt flow index of about 3.5 g/10 min or greater as measured by ASTM D 1238 at 190°C/2 1.5 kg weight and having an ash content of about 500 ppm or less may be useful biomedical devices, including kits and methods relating thereto. BIOMEDICAL DEVICES COMPRISING MOLDED POLYETHYLENE COMPONENTS BACKGROUND [0001] The present invention relates to molded polyethylene components for use in conjunction with biomedical devices, including methods relating thereto. [0002] Polyethylene is often used in conjunction with biomedical devices because of, inter alia, its chemical resistance, biocompatibility, low specific gravity relative to metals, and wear resistance. Typically, polyethylene, having a purity sufficient for use in biological environments (e.g., minimal concentration of residual catalyst), has a low melt flow index, and in some instances essentially no melt flow index. Due to the hardness of low melt flow index polyethylene, production of biomedical devices and components therefrom is typically achieved through machining methods. While machining fabrication methods may allow for high precision components capable of meeting tight tolerances, these methods generally have a low throughput and can produce significant waste of the polyethylene material, both of which increase the cost of manufacturing. Further, machine fabrication can require large capital investments in equipment. Accordingly, methods and compositions that enable higher throughput manufacturing, like molding, may be desirable in the production of polyethylene-based biomedical device components. SUMMARY OF THE INVENTION [0003] The present invention relates to molded polyethylene components for use in conjunction with biomedical devices, including methods relating thereto. [0004] I n one embodiment, the present invention provides for a biomedical device that comprises a molded polyethylene component that comprises a polyethylene composition that comprises polyethylene having a melt flow index of about 3.5 g/10 min or greater as measured by ASTM D1238 at 190°C/21.5 kg weight and having an ash content of about 500 ppm or less. [0005] I n another embodiment, the present invention provides for a biomedical device that comprises a conduit that comprises at least one wall defining an internal volume, the at least one wall comprising polyethylene having a melt flow index of about 3.5 g/10 min or greater as measured by ASTM D1238 at 190°C/21.5 kg weight and having an ash content of about 500 ppm or less. [0006] I n yet another embodiment, the present invention provides for a method that comprises providing a polyethylene composition melt that comprises polyethylene having a melt flow index of about 3.5 g/10 min or greater as measured by ASTM D1238 at 190°C/21.5 kg weight and having an ash content of about 500 ppm or less; and extruding the polyethylene composition melt t o form a molded polyethylene component of a biomedical device. [0007] I n another embodiment, the present invention provides for a method that comprises providing a polyethylene composition melt that comprises polyethylene having a melt flow index of about 3.5 g/10 min or greater as measured by ASTM D1238 at 190°C/21.5 kg weight and having an ash content of about 500 ppm or less; and injection molding the polyethylene composition melt to form a molded polyethylene component of a biomedical device. [0008] I n yet another embodiment, the present invention provides for a method that comprises providing a component of a biomedical device; and substantially encasing the component in polyethylene having a melt flow index of about 3.5 g/10 min or greater as measured by ASTM D1238 at 190°C/21.5 kg weight and having an ash content of about 500 ppm or less. [0009] I n yet another embodiment, the present invention provides for a method that comprises polymerizing at least one olefin in the presence of a catalyst so as t o form polyethylene having a melt flow index of about 3.5 g/10 min or greater as measured by ASTM D1238 at 190°C/21.5 kg weight, the at least one olefin being selected from the group consisting of ethylene, propylene, and/or butylene, and any combination thereof; and treating the polyethylene to yield a treated polyethylene having an ash content of about 500 ppm or less. [0010] I n another embodiment, the present invention provides for a method that comprises providing a sheet comprising a polyethylene composition that comprises polyethylene having a melt flow index of about 3.5 g/10 min or greater as measured by ASTM D1238 at 190°C/21.5 kg weight and having an ash content of about 500 ppm or less; and thermoforming the sheet into a molded polyethylene component of a biomedical device. [0011] I n yet another embodiment, the present invention provides for a method that comprises providing a sheet comprising a polyethylene composition that comprises polyethylene having a melt flow index of about 3.5 g/10 min or greater as measured by ASTM D1238 at 190°C/21.5 kg weight and having an ash content of about 500 ppm or less; and shrink wrapping the sheet onto a portion of a biomedical device or component thereof. [0012] The features and advantages of the present invention will be readily apparent to those skilled in the art upon a reading of the description of the preferred embodiments that follows. DETAILED DESCRIPTION [0013] The present invention relates to molded polyethylene components for use in conjunction with biomedical devices, including methods relating thereto. I n some instances, the molded polyethylene components may be biomedical devices themselves. [0014] The molded polyethylene components of the present invention for use in conjunction with biomedical devices may, in some embodiments, comprise polyethylene compositions with high purity that is melt flowable, thereby enabling the molded polyethylene components to be produced via molding and/or extruding methods. The ability to form a polyethylene component via these methods may advantageously enable faster production of high precision components as compared to machining methods. Molding method may also enable the production of complex and smaller components that are time and cost prohibitive if produced by machining methods. Further, the waste associated with manufacturing may be reduced as compared to machining methods. Accordingly, for at least these reasons, the ability to mold and/or extrude polyethylene components of the present invention for use in conjunction with biomedical devices as described herein may, in turn, reduce manufacturing costs, and consequently consumer costs, which especially in the biomedical sector may be especially advantageous. [0015] It should be noted that when "about" is provided at the beginning of a numerical list, "about" modifies each number of the numerical list. It should be noted that in some numerical listings of ranges, some lower limits listed may be greater than some upper limits listed. One skilled in the art will recognize that the selected subset will require the selection of an upper limit in excess of the selected lower limit.
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