# US 2016/0354532 A1 · Cannular Device and Method of Manufacture > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2016/0354532 A1 - Document ID: US20160354532A1 - Status: Published application - Kind: A1 - Application number: 15/239,390 - Filed: 2016-08-17 - Published: 2016-12-08 - Earliest claimed: 2010-10-14 - Assignees: Medtronic, Inc. - Applicants: Medtronic, Inc. - Inventors: Christopher Alan Oleksy; Roger Warren Brink - Web page: https://patentgrep.com/patent/US20160354532A1 ## CPC - A61M 1/3659: {Cannulae pertaining to extracorporeal circulation} - A61L 29/041: {obtained by reactions only involving carbon-to-carbon unsaturated bonds} - A61L 29/06: obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds - A61L 29/14: Materials characterised by their function or physical properties {, e.g. lubricating compositions} - A61M 25/0009: {Making of catheters or other medical or surgical tubes} - A61M 25/0021: {characterised by the form of the tubing (A61M25/0054 takes precedence)} - A61M 25/0023: {by the form of the lumen, e.g. cross-section, variable diameter} - A61M 25/0043: {characterised by structural features} - B29C 48/0022: {combined with cutting} - B29C 48/10: flexible, e.g. blown foils - B29C 48/13: Articles with a cross-section varying in the longitudinal direction, e.g. corrugated pipes - B29C 48/919: {using a bath, e.g. extruding into an open bath to coagulate or cool the material} - B29C 55/22: of tubes {(B29C61/08 takes precedence)} - A61M 2025/0059: {having means for preventing the catheter, sheath or lumens from collapsing due to outer forces, e.g. compressing forces, or caused by twisting or kinking} - A61M 2207/00: Methods of manufacture, assembly or production - B29C 48/09: Articles with cross-sections having partially or fully enclosed cavities, e.g. pipes or channels - B29C 2948/92704: Temperature - B29C 2948/92876: Feeding, melting, plasticising or pumping zones, e.g. the melt itself - B29K 2021/003: {Thermoplastic elastomers} - B29K 2995/0056: Biocompatible, e.g. biopolymers or bioelastomers - B29L 2023/007: {Medical tubes other than catheters (catheters B29L2031/7542)} - B29L 2031/7542: {Catheters} - 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)} - 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) - B29C: SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING (making preforms B29B11/00; making laminated products by combining previously unconnected layers which become one product whose layers will remain together B32B37/00 - B32B41/00) - B29K: INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR {MOULDS, } REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS - B29L: INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES ## Abstract A cannula comprising a polymeric material which is phthalate-free, yet retains flexibility, workability and elongation properties so as to avoid kinking when bent. Also disclosed is a method of manufacturing a cannular device comprising extruding a flexible, biocompatible, phthalate-free polymeric composition through a round die into a tube, pulling the tube through a water bath at a rate established according to a predetermined function, and cutting the tube to for a cannular device, wherein the predetermined function periodically modulates a pulling rate. ## Claims ### Claim at position 1 1-22. (canceled) ### Claim 23 A method of manufacturing a cannular device, comprising: extruding a flexible, biocompatible, phthalate-free polymeric composition through a round die into a tube; pulling the tube through a water bath at a rate established according to a predetermined function; and cutting the tube to form a cannular device; wherein the predetermined function periodically modulates a pulling rate. ### Claim 24 (depends on 23) The method of claim 23, wherein the predetermined function provides periods in which the pulling rate increases from a minimal pulling rate to a maximal pulling and periods in which the pulling rate decreases from a maximal pulling rate to a minimal pulling rate so that the tube is formed having an oscillating cross-sectional diameter that changes with time. ### Claim 25 (depends on 24) The method of claim 24, wherein the predetermined function further provides periods in which the pulling rate is not modulated. ### Claim 26 (depends on 25) The method of claim 25, wherein the predetermined function further provides that the periods in which the pulling rate is not modulated are interposed between periods in which the pulling rate is modulated. ### Claim 27 (depends on 25) The method of claim 25, wherein the cut tube is adapted to resist kinking when tested according to an 180° bend test. ### Claim 28 (depends on 25) The method of claim 25, wherein the polymeric composition is free of plasticizers. ### Claim 29 (depends on 25) The method of claim 25, wherein the polymeric composition comprises a thermoplastic elastomer. ### Claim 30 (depends on 29) The method of claim 29, wherein the thermoplastic elastomer has a Shore A hardness in a range from about 45 to about 85. ### Claim 31 (depends on 25) The method of claim 25, wherein the tube is adapted for recovering to full patency to cause the inner lumen to remain free from obstruction after being clamped to complete closure. ### Claim 32 (depends on 25) The method of claim 25, wherein the cut tube has a circular cross-section defining an inner diameter and an outer diameter, the circular cross-section diminishing in size along a length from a first inner diameter and a first outer diameter to a second inner diameter and a second outer diameter, the first inner diameter being larger than the second inner diameter and the first outer diameter being larger than the second outer diameter. ### Claim 33 (depends on 25) The method of claim 25, wherein the cut tube has a proximal end and a distal end, the proximal end having a first inner diameter and a first outer diameter defining a first thickness, the distal end having a second inner diameter and a second outer diameter defining a second thickness, wherein the second thickness is about 50 to about 95% of the first thickness. ### Claim 34 (depends on 25) The method of claim 25, wherein the tube is sufficiently clear so that fluids passing through the tube can be observed. ### Claim 35 (depends on 25) The method of claim 25, wherein the cut tube has a proximal end and a distal end, wherein the cut tube is tapered from the proximal end to the distal end. ### Claim 36 A method of manufacturing a cannular device, comprising: extruding a flexible, biocompatible, phthalate-free polymeric composition through a round die into a tube; pulling the tube through a water bath at a rate established according to a predetermined function; and cutting the tube to form a cannular device; wherein the predetermined function provides periods in which the pulling rate increases from a minimal pulling rate to a maximal pulling and periods in which the pulling rate decreases from a maximal pulling rate to a minimal pulling rate so that the tube is formed having an oscillating cross-sectional diameter that changes with time; wherein the cut tube has a proximal end and a distal end, the proximal end having a first inner diameter and a first outer diameter defining a first thickness, the distal end having a second inner diameter and a second outer diameter defining a second thickness, wherein the second thickness is about 50 to about 95% of the first thickness. ### Claim 36 A method of manufacturing a cannular device, comprising: extruding a flexible, biocompatible, phthalate-free polymeric composition through a round die into a tube; pulling the tube through a water bath at a rate established according to a predetermined function; and cutting the tube to form a cannular device; wherein the tube is adapted to resist kinking and to recover to full patency after being clamped to complete closure.