# US 10,946,171 B2 · Catheter devices and methods for making them > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,946,171 B2 - Document ID: US10946171B2 - Status: Granted - Kind: B2 - Application number: 16/267,333 - Filed: 2019-02-04 - Published: 2019-08-08 - Granted: 2021-03-16 - Earliest claimed: 2014-09-21 - Assignees: Clph, LLC - Applicants: Clph, LLC - Inventors: Stephen A. Leeflang; Christian S. Eversull - Web page: https://patentgrep.com/patent/US10946171B2 ## CPC - A61M 25/005: {with embedded materials for reinforcement, e.g. wires, coils, braids} - A61M 25/0012: {with embedded structures, e.g. coils, braids, meshes, strands or radiopaque coils} - A61M 25/0113: {Mechanical advancing means, e.g. catheter dispensers} - A61M 25/0147: {with movable mechanical means, e.g. pull wires} - 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 Catheters, sheaths, or other tubular devices are provided that include a proximal end, a distal end sized for introduction into a patient's body, and a steerable distal portion. The tubular device includes a primary lumen extending between the proximal and distal ends; an auxiliary lumen adjacent the primary lumen; and one or more reinforcement members including windings extending helically along at least the distal portion, at least some of the windings passing between the primary and steering element lumens and at least some of the windings surrounding both the primary and steering element lumens. In one embodiment, a steering element is slidably disposed within the auxiliary lumen. Apparatus and methods for making such tubular devices are also provided. ## Claims ### Claim 1 A method for making a tubular body using a braiding apparatus comprising a plurality of horn gears rotatably mounted around a central axis in a predetermined arrangement such that the horn gears rotate about respective horn gear axes and carriers travel along a generally circular path around the central axis during operation of the braiding apparatus, the method comprising: directing an elongate first mandrel through a first passage aligned with a first horn gear axis of a first horn gear of the horn gears towards the central axis; wrapping reinforcement members from the carriers around the first mandrel to create a braided assembly having a braiding configuration where at least one of a density and a pitch angle of the reinforcement members vary around a periphery of the first mandrel; applying an outer jacket around the braided assembly to provide a tubular body; and removing the first mandrel to define a first lumen within the tubular body. ### Claim 2 (depends on 1) The method of claim 1, wherein the braiding configuration comprises a relatively low density of strands of the reinforcement members around a first region of the periphery of the first mandrel and a relatively high density of strands of the reinforcement members a second region of the periphery. ### Claim 3 (depends on 2) The method of claim 2, wherein the strands around the first region define a first pitch angle and the strands around the second region define a second pitch angle that is lower than the first pitch angle. ### Claim 4 (depends on 1) The method of claim 1, further comprising directing an elongate second mandrel through a second passage aligned with a second horn gear axis of a second horn gear of the horn gears towards the central axis, wherein the reinforcement members are simultaneously wrapped around the first and second mandrels to create the braided assembly. ### Claim 5 (depends on 4) The method of claim 4, further comprising removing the second mandrel to define a second lumen within the tubular body adjacent the first lumen. ### Claim 6 (depends on 4) The method of claim 4, wherein the first and second horn gears are opposite one another across the central axis such that the braiding configuration includes two relatively dense clusters of reinforcement elements between the first and second mandrels in the braided assembly. ### Claim 7 (depends on 6) The method of claim 6, further comprising directing a secondary mandrel through a third passage aligned with a third horn gear other than the first and second horn gears, the secondary mandrel having a maximum cross-section that is substantially smaller than maximum cross-sections of the first and second mandrels. ### Claim 8 (depends on 6) The method of claim 6, further comprising directing a pair of secondary mandrels through passages of opposite horn gears spaced around the braiding apparatus from the first and second horn gears, the secondary mandrels having a maximum cross-section that is substantially smaller than maximum cross-sections of the first and second mandrels, wherein the secondary mandrels are braided into the strands at the second regions. ### Claim 9 (depends on 8) The method of claim 8, further comprising removing the secondary mandrels from the tubular body. ### Claim 10 (depends on 4) The method of claim 4, wherein the first and second horn gears are opposite one another across the central axis such that the braiding configuration includes a relatively low density of strands of the reinforcement members around first regions of peripheries of the first and second mandrels disposed away from one another and a relatively high density of strands of the reinforcement members at second regions of the peripheries disposed towards one another. ### Claim 11 (depends on 1) The method of claim 1, further comprising directing an elongate second mandrel through the first passage, wherein the reinforcement members are simultaneously wrapped around the first and second mandrels to create the braided assembly. ### Claim 12 (depends on 1) The method of claim 1, further comprising directing an elongate guide member along the central axis such that the reinforcement members are braided around the guide member with the first mandrel disposed adjacent the guide member. ### Claim 13 (depends on 12) The method of claim 12, wherein the guide member has a maximum cross-section that is smaller than a maximum cross-section of the first mandrel. ### Claim 14 (depends on 12) The method of claim 12, further comprising removing the guide member from the tubular body. ### Claim 15 A method for making a tubular body using a braiding apparatus comprising a plurality of horn gears rotatably mounted around a central axis in a predetermined arrangement such that the horn gears rotate about respective horn gear axes and carriers travel along a generally circular path around the central axis during operation of the braiding apparatus, the method comprising: directing a plurality of elongate mandrels through passages aligned with horn gear axes of respective horn gears of the horn gears towards the central axis; wrapping reinforcement members from the carriers around the mandrels to create a braided assembly having a braiding configuration where at least one of a density and a pitch angle of the reinforcement members vary around a periphery of the mandrels; applying an outer jacket around the braided assembly to provide a tubular body; and removing the mandrels to define respective lumens within the tubular body. ### Claim 16 (depends on 15) The method of claim 15, directing a plurality of elongate mandrels through passages aligned with horn gear axes of respective horn gears of the horn gears towards the central axis comprises directing first and second mandrels through passages in first and second horn gears opposite one another across the central axis such that the braiding configuration includes two relatively dense clusters of reinforcement elements between the first and second mandrels in the braided assembly. ### Claim 17 (depends on 16) The method of claim 16, wherein the first and second horn gears are opposite one another across the central axis such that the braiding configuration includes a relatively low density of strands of the reinforcement members around first regions of peripheries of the first and second mandrels disposed away from one another and a relatively high density of strands of the reinforcement members at second regions of the peripheries disposed towards one another. ### Claim 18 (depends on 16) The method of claim 16, further comprising directing a secondary mandrel through a third passage aligned with a third horn gear other than the first and second horn gears, the secondary mandrel having a maximum cross-section that is substantially smaller than maximum cross-sections of the first and second mandrels. ### Claim 19 (depends on 16) The method of claim 16, further comprising directing a pair of secondary mandrels through passages of opposite horn gears spaced around the braiding apparatus from the first and second horn gears, the secondary mandrels having a maximum cross-section that is substantially smaller than maximum cross-sections of the first and second mandrels, wherein the secondary mandrels are braided into the strands at the second regions. ### Claim 20 A tubular device for a catheter or sheath comprising a proximal end and a distal end sized for introduction into a patient's body, the tubular device comprising: a lumen extending at least partially between the proximal and distal ends; a plurality of reinforcement members comprising windings extending helically around the lumen at least partially between the proximal and distal ends; and one or more layers surrounding the one or more reinforcement members, wherein the reinforcement members have a braiding configuration where at least one of a density and a pitch angle of the reinforcement members vary around a periphery of the lumen.