US-12616816-B2 - Catheter devices and methods for making them

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.

Inventors

• Stephen Arie Leeflang
• Christian Scott Eversull

Assignees

• CLPH, LLC

Dates

Publication Date

20260505

Application Date

20231222

Claims (20)

1. 1 . A tubular device for a catheter or, the tubular device comprising: a proximal end and a distal end sized for introduction into a patient's body; a central lumen extending between the proximal end and the distal end; an auxiliary lumen extending at least partially between the proximal end and the distal end adjacent the central lumen; an elongate member received within the auxiliary lumen; one or more reinforcement members comprising windings extending helically around the central lumen at least partially between the proximal end and the distal end; and one or more layers surrounding the one or more reinforcement members, wherein the tubular device comprises a first portion in which at least some of the windings pass between the central lumen and the elongate member and at least some of the windings surround both the central lumen and the elongate member, and a second portion in which either a) all of the windings surround both the central lumen and the elongate member or b) all of the windings surround the central lumen and the elongate member is disposed outside the windings.
2. 2 . The tubular device of claim 1 , further comprising one or more additional auxiliary lumens.
3. 3 . The tubular device of claim 2 , wherein the tubular member includes a pair of auxiliary lumens provided on opposite sides of the central lumen, each auxiliary lumen including an elongate member therein.
4. 4 . The tubular device of claim 3 , wherein the pair of auxiliary lumens are offset about one hundred eighty degrees (180°) around the circumference of the tubular member.
5. 5 . The tubular device of claim 1 , wherein, along the second portion, all of the windings surround both the central lumen and the elongate member.
6. 6 . The tubular device of claim 5 , wherein the tubular device further comprises a third portion adjacent the first portion in which a) at least some of the windings pass between the central lumen and the elongate member and at least some of the windings surround both the central lumen and the elongate member, or b) all of the windings surround the central lumen and the elongate member is disposed outside the windings.
7. 7 . The tubular device of claim 1 , wherein, along the second portion, all of the windings surround the central lumen and the elongate member is disposed outside the windings.
8. 8 . The tubular device of claim 7 , wherein the tubular device further comprises a third portion adjacent the first portion in which a) at least some of the windings pass between the central lumen and the elongate member and at least some of the windings surround both the central lumen and the elongate member, or b) all of the windings surround the central lumen and the elongate member is disposed outside the windings.
9. 9 . The tubular device of claim 1 , wherein the central lumen is substantially aligned around a central longitudinal axis extending between the proximal end and the distal end, and wherein the auxiliary lumen is offset radially from the central axis.
10. 10 . The tubular device of claim 1 , wherein the elongate member comprises a steering element and wherein the steering element is coupled to the distal end, the steering element configured to apply an axial force to a distal portion of the tubular device and thereby generate a bending moment to bend the distal portion.
11. 11 . The tubular device of claim 1 , wherein the elongate member comprises a steering element, the tubular device further comprising a pull wire ring adjacent the distal end and wherein a distal end of the steering element is coupled to the pull wire ring.
12. 12 . The tubular device of claim 11 , wherein the reinforcement members are braided around only the central lumen at a distal portion of the tubular member.
13. 13 . The tubular device of claim 11 , wherein the reinforcement members terminate at or near a distal edge of the pull wire ring with the pull wire ring constraining the reinforcement members and a jacket and/or tip is bonded, laminated, reflowed or otherwise attached over beyond the pull wire ring.
14. 14 . The tubular device of claim 1 , wherein the elongate member comprises an elongate conductor.
15. 15 . The tubular device of claim 14 , further comprising one or more sensors or electrodes on a distal portion of the tubular member adjacent the distal end, the conductor coupled to the one or more sensors or electrodes.
16. 16 . The tubular device of claim 15 , wherein the distal portion comprises the first portion of the tubular device.
17. 17 . The tubular device of claim 16 , wherein the conductor comprises one or more segments that transition outside the reinforcement layer, the one or more segments coupled to the one or more sensors or electrodes.
18. 18 . The tubular device of claim 14 , further comprising a plurality of electrodes spaced apart on a distal portion of the tubular member adjacent the distal end, the conductor coupled to the plurality of electrodes.
19. 19 . The tubular device of claim 18 , wherein the distal portion comprises the first portion of the tubular device.
20. 20 . The tubular member of claim 1 , wherein the elongate member comprises a steering element slidably received in the auxiliary lumen.

Description

RELATED APPLICATION DATA This application is a continuation of co-pending application Ser. No. 16/915,947, filed Jun. 29, 2020, issuing as U.S. Pat. No. 11,850,375, which is a continuation of Ser. No. 16/186,436, filed Nov. 9, 2018, now U.S. Pat. No. 10,695,532, which is a continuation of application Ser. No. 15/464,360, filed Mar. 21, 2017, now U.S. Pat. No. 10,124,145, which is a continuation of International Application No. PCT/US2015/051284, filed Sep. 21, 2015, which claims benefit of provisional application Ser. No. 62/053,188, filed Sep. 21, 2014, the entire disclosures of which are expressly incorporated by reference herein. FIELD OF THE INVENTION The present invention relates generally to reinforced catheters, sheaths, or other tubular devices including multiple lumens, and, more particularly, to catheters, sheaths, or other tubular devices including braided or other reinforcement configurations and one or more lumens that change position relative to the reinforcement members and/or a central lumen along the length of the tubular devices, and to methods for making such tubular devices. BACKGROUND Elongate tubular devices, such as diagnostic or treatment catheters or sheaths may be provided for introduction into a patient's body, e.g., the patient's vasculature or other body lumens. For example, a catheter may have a distal portion configured to be introduced into a body lumen and advanced to one or more desired locations within the patient's body by manipulating a proximal end of the catheter. To facilitate introduction of such a catheter, one or more wires, cables, or other steering elements may be provided within the catheter, e.g., that are coupled to the distal portion and may be pulled or advanced from the proximal end to deflect the distal portion. For example, a steering element may be provided that is intended to deflect the distal portion within a predetermined plane and/or into a desired curved shape. Pull wires are a common way to impart deflection ability to such a catheter. However, there are a number of drawbacks associated with such pull wires. For example, a pull wire occupies a significant amount of space within the catheter body. In addition, a pull wire frequently needs to be reinforced, e.g., on the inside and outside of the braid or other reinforcement of the catheter, e.g., to prevent “pull through” or loosening when the pull wire is actuated by pushing or pulling, i.e., the resulting bending moment may cause the pull wire to separate layers of or tear at least partially through the wall of catheter, potentially splitting the catheter and/or decreasing the mechanical actuation ability of the pull wire. Further, a pull wire can make the torque properties of the catheter non-homogenous, making it difficult or impossible to torque the catheter when the pull wire is actuated, e.g., within a tortuous pathway. Further, auxiliary lumens, in particular those located in the wall of a large bore sheath, are difficult to manufacture with consistency due to difficulties with alignment, hand assembly, and the like. Accordingly, there is a need for improved catheters, sheaths, and other tubular devices and methods of their manufacture. SUMMARY The present invention is directed to reinforced catheters, sheaths, or other tubular devices including multiple lumens. More particularly, the present invention is directed to catheters, sheaths, or other tubular devices, e.g., steerable tubular devices, including braided or other reinforcement configurations and one or more lumens that change position relative to the reinforcement members and/or a central lumen along the length of the tubular devices, and/or to methods for making such catheters, sheaths, or other tubular devices. In accordance with one embodiment, a tubular device is provided, e.g., for a catheter or sheath, comprising a proximal end and a distal end sized for introduction into a patient's body. The tubular device may include a central lumen extending between the proximal and distal ends; an auxiliary lumen extending between the proximal and distal ends adjacent the central lumen; and one or more reinforcement members including windings extending around the central lumen between the proximal and distal ends. In addition, one or more layers may surround the one or more reinforcement members and/or the lumens. At one or more locations along the length of the tubular device, the auxiliary lumen may change position relative to the reinforcement members, e.g., may be at least partially braided, woven, or directed into the reinforcement members, between the reinforcement members and the central lumen, and outside the reinforcement members along different portions of the tubular device. In accordance with yet another embodiment, a method is provided for making a tubular body that includes directing a primary mandrel along a central axis of a braiding apparatus such that the primary mandrel is surrounded by a plurality of horn gears and/or b