# US 10,245,413 B2 · Distal access aspiration guide catheter > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,245,413 B2 - Document ID: US10245413B2 - Status: Granted - Kind: B2 - Application number: 13/878,890 - Filed: 2011-10-03 - Published: 2014-02-13 - Granted: 2019-04-02 - Earliest claimed: 2010-10-04 - Assignees: Covidien LP - Applicants: Lynn Shimada; Seferino Torres; Brian Strauss; Jeffrey Valko - Inventors: Lynn Shimada; Seferino Torres; Brian Strauss; Jeffrey Valko - Web page: https://patentgrep.com/patent/US10245413B2 ## CPC - A61M 25/0053: {having a variable stiffness along the longitudinal axis, e.g. by varying the pitch of the coil or braid} - A61B 5/6852: {Catheters} - A61B 10/04: Endoscopic instruments, e.g. catheter-type instruments - A61B 17/320016: {Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes (A61B10/0233, A61B17/29, A61B17/3207 take precedence)} - A61L 29/02: Inorganic materials - A61L 29/06: obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds - A61L 29/085: {Macromolecular materials} - A61L 29/126: {having a macromolecular matrix} - A61M 25/0012: {with embedded structures, e.g. coils, braids, meshes, strands or radiopaque coils} - A61M 25/0045: {multi-layered, e.g. coated (coating materials A61L29/08)} - A61M 25/005: {with embedded materials for reinforcement, e.g. wires, coils, braids} - A61M 25/0054: {with regions for increasing flexibility} - A61M 25/10: Balloon catheters ({A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02;} inflatable balloons for placing stents or stent-grafts A61F2/958 {; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00}) - 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} - Y10T 29/49826: Assembling or joining - Y10T 29/49865: by temperature differential [e.g., shrink fit] - 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)} - 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) - Y10T: TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION ## Abstract Distal access aspiration guide catheter system and methods for delivering implantable devices, catheters, or substances in or near and/or restoring flow through body lumens, such as blood vessel lumens are described. A Distal access aspiration guide catheter having a proximal, medial, and distal possessing high flexibility, high resistance to kinking and a large lumen to wall thickness ratio. ## Claims ### Claim 1 A catheter device comprising: an elongate tubular catheter body having a proximal end and a distal end and a passageway defining an inner lumen extending between those ends, the elongate tubular catheter body comprising an inner tubular liner of a first liner material in coaxial relationship with an outer tubular cover, a tubular member between the inner tubular liner and the outer tubular cover, and a hydrophilic coating on an outer surface of the outer tubular cover, the tubular member comprising a metal helix defining a helical gap and a polymeric kink resistance member comprising a thermoset polymer positioned within the helical gap of the metal helix, and the catheter body, in the region of the distal end, having an inner diameter to wall thickness ratio greater than or equal to 16:1 and a kink radius of about 4.42 millimeters (mm)+/−0.203 mm (about 0.174 inch+/−0.008 inch) or less. ### Claim 2 A guide catheter comprising: an elongate tubular member having a proximal end and a distal end and a passageway defining an inner lumen extending between those ends, the elongate tubular member comprising: a) a relatively stiff proximal segment, the proximal segment comprising an inner proximal tubular liner comprising a proximal liner material in coaxial relationship with an outer proximal tubular cover comprising a proximal cover material, a metallic braid structure positioned upon the inner proximal tubular liner and covered by the outer proximal tubular cover; b) a relatively flexible distal segment, the distal segment comprising an inner distal tubular liner comprising a distal liner material in coaxial relationship with an outer distal tubular cover comprising a distal cover material, a distal tubular member between the distal liner material and the distal cover material, the distal tubular member comprising and a metal helix defining a helical gap and a polymeric kink resistance member structure positioned within the helical gap, the elongate tubular member, in the region of the distal end, having an inner diameter to wall thickness ratio greater than or equal to 16:1 and a kink radius of about 4.42 millimeters (mm)+/−0.203 mm (about 0.174 inch+/−0.008 inch) or less; and c) at least one intermediate segment defining a passageway between the relatively stiff proximal segment and the relatively flexible distal segment, the at least one intermediate segment providing a transition from the metallic braid structure to the distal tubular member. ### Claim 3 A catheter device comprising: a catheter body comprising: a tubular member having an inner lumen and an outer surface, said tubular member comprising a metal structure having a helical gap and a polymeric material disposed within the helical gap; an inner liner extending through the lumen of the tubular member and defining an inner lumen of the catheter; and an outer cover on the outer surface of the tubular member, wherein the polymeric material disposed within the helical gap is different from the materials of the inner liner and the outer cover, and wherein a distal region of the catheter body has an inner diameter to wall thickness ratio greater than or equal to 16:1 and a kink radius of about 4.42 millimeters (mm)+/−0.203 mm (about 0.174 inch+/−0.008 inch) or less. ### Claim 4 (depends on 3) The catheter device of claim 3 wherein the distal region of the catheter body has an inner diameter to wall thickness ratio in a range of 16:1 to 24:1. ### Claim 5 (depends on 3) The catheter device of claim 3 wherein the distal region of the catheter body has a lateral flexibility of greater than or equal to 1200 degrees of deflection per pound-force inch. ### Claim 6 (depends on 3) The catheter device of claim 3 wherein the distal region of the catheter body has an Ultimate Tensile Strength of 22 Newtons. ### Claim 7 (depends on 3) The catheter device of claim 3, wherein the tubular member extends to a distal end of the catheter body. ### Claim 8 (depends on 3) The catheter device according to claim 3 wherein the metal structure comprises nickel titanium alloy. ### Claim 9 (depends on 3) The catheter device according to claim 3 wherein the metal structure comprises nickel titanium alloy ribbon. ### Claim 10 (depends on 3) The catheter device according to claim 3 wherein the metal structure is a metal helix having the helical gap. ### Claim 11 (depends on 10) The catheter device according to claim 10 wherein the helical gap is of continuous width. ### Claim 12 (depends on 10) The catheter device according to claim 10 wherein a dimension of the metal helix and/or width of the helical gap varies. ### Claim 13 (depends on 3) The catheter device according to claim 3 wherein the polymeric material comprises an elastomer. ### Claim 14 (depends on 3) The catheter device according to claim 3 wherein the polymeric material comprises a cast elastomer. ### Claim 15 (depends on 3) The catheter device according to claim 3 wherein the polymeric material comprises a cast polyurethane. ### Claim 16 (depends on 15) The catheter device according to claim 15 wherein the cast polyurethane comprises a thermoset polyurethane adhesive. ### Claim 17 (depends on 3) The catheter device according to claim 3 wherein the inner liner comprises at least one material selected from the group consisting of: fluoropolymers; PTFE; PFA; and FEP. ### Claim 18 (depends on 3) The catheter device according to claim 3 wherein the outer cover comprises at least one material selected from the group consisting of: polyesters and polyolefins. ### Claim 19 (depends on 10) The catheter device according to claim 10 wherein the catheter device has a plurality of regions along its length wherein a dimension of the metal helix and/or a width of the helical gap differ between said regions. ### Claim 20 (depends on 3) The catheter device according to claim 3 wherein the catheter device has a proximal region, a medial region and a distal region. ### Claim 21 (depends on 20) The catheter device according to claim 20 wherein the outer cover on the proximal region comprises polyester having a thickness of about 0.001 inch; the outer cover on the medial region comprises polyester having a thickness of about 0.0005 inch and the outer cover on the distal region comprises polyolefin having a thickness of about 0.0005 inch. ### Claim 22 (depends on 3) The catheter device according to claim 3 further comprising a balloon. ### Claim 23 (depends on 22) The catheter device according to claim 22 wherein the balloon comprises a compliant balloon. ### Claim 24 (depends on 3) The catheter device according to claim 3 wherein the polymeric material disposed within the helical gap is a thermoset polymer. ### Claim 25 A method for manufacturing a catheter, the method comprising: forming a catheter body, wherein forming the catheter body comprises: A) forming or obtaining a metal helix defining a helical gap; B) disposing polymeric material comprising a thermoset polymer within the helical gap such that the polymeric material and the metal helix, in combination, form a tubular member having an outer surface and a lumen; C) disposing an inner liner within the lumen of the tubular member; and D) disposing an outer cover on the outer surface of the tubular member, wherein a distal region of the catheter body has an inner diameter to wall thickness ratio greater than or equal to 16:1 and a kink radius of about 4.42 millimeters (mm)+/−0.203 mm (about 0.174 inch+/−0.008 inch) or less. ### Claim 26 (depends on 25) The method according to claim 25 wherein disposing the inner liner within the lumen of the tubular member comprises disposing the inner liner on a mandrel and positioning the metal helix on top of the inner liner. ### Claim 27 (depends on 26) The method according to claim 26 wherein the metal helix comprises a nickel titanium alloy and disposing the inner liner within the lumen of the tubular member comprises winding the nickel titanium alloy about the inner liner and then heat setting the nickel titanium alloy. ### Claim 28 (depends on 26) The method according to claim 26 wherein disposing the inner liner within the lumen of the tubular member comprises casting a flowable polymer mixture into the helical gap and solidifying the flowable polymer, thereby forming the tubular member with the inner liner disposed therein. ### Claim 29 (depends on 28) The method according to claim 28 wherein the polymer comprises a polymer adhesive. ### Claim 30 (depends on 29) The method according to claim 29 further comprising applying a release agent or barrier to one or more selected areas of the metal helix to deter or interrupt adhesion of the polymer adhesive to the selected areas of the metal helix. ### Claim 31 (depends on 29) The method according to claim 29 wherein the polymer adhesive causes adhesion between the tubular member and the inner liner. ### Claim 32 (depends on 29) The method according to claim 29 further comprising disposing a quantity of the polymer adhesive between the outer surface of the tubular member and the inner surface of the outer cover to cause adhesion between the tubular member and the outer cover. ### Claim 33 (depends on 25) The method according to claim 25 wherein the outer cover comprises a tube that initially has an inner diameter that is larger than the outer diameter of the tubular member and wherein disposing the outer cover on the outer surface of the tubular member comprises advancing the outer cover over the tubular member and causing the outer cover to contact the outer surface of the tubular member. ### Claim 34 (depends on 33) The method according to claim 33 further comprising heat shrinking the outer cover onto the outer surface of the tubular member. ### Claim 35 (depends on 25) The method according to claim 25 further comprising disposing a radiographic marker on or in the catheter body. ### Claim 36 (depends on 25) The method according to claim 25 further comprising applying a hydrophilic coating to an outer surface of the outer cover. ### Claim 37 A method for treating or diagnosing a disorder in a human or animal subject, said method comprising: inserting a catheter into the subject's vasculature, the catheter including: a tubular member having an inner lumen and an outer surface, said tubular member comprising a metal helix having a helical gap and a polymeric material disposed within the helical gap; an inner liner extending through the lumen of the tubular member and defining an inner lumen of the catheter; and an outer cover on the outer surface of the tubular member; wherein the polymeric material disposed within the helical gap is different from the materials of the inner liner and the outer cover and wherein a distal region of the catheter body has an inner diameter to wall thickness ratio greater than or equal to 16:1 and a kink radius of about 4.42 millimeters (mm)+/−0.203 mm (about 0.174 inch+/−0.008 inch or less); delivering a substance or device through the lumen of the catheter device; and using the substance or device to treat or diagnose the disorder. ### Claim 38 (depends on 37) The method according to claim 37 wherein inserting the catheter comprises advancing the catheter device into a blood vessel located within the subject's skull. ### Claim 39 (depends on 38) The method according to claim 38 further comprising selecting the blood vessel into which the catheter device is advanced from the group consisting of: carotid artery, cerebral artery, anterior cerebral artery, middle cerebral artery and posterior cerebral artery.