Catheter devices and methods for making them

• US 9,999,745 B2
• Filed: 11/04/2015
• Issued: 06/19/2018
• Est. Priority Date: 11/05/2014
• Status: Active Grant

• Current Assignee: CLPH, LLC
• Original Assignee: CLPH, LLC
• Inventors: Leeflang, Stephen A., Eversull, Christian S.
• Primary Examiner(s): Besler, Christopher
• Application Number:
  US14/932,763
• Publication Number:
  US 20160158490A1
• Time in Patent Office: 958 Days
• Field of Search: 87 34
• CPC Class Codes: A61B 2562/0215 Silver or silver chloride containing
• CPC Class Codes: A61B 5/287 Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
• CPC Class Codes: A61B 5/6852 Catheters
• CPC Class Codes: A61M 25/0012 with embedded structures, e.g. coils, braids, meshes, strands or radiopaque coils
• CPC Class Codes: A61M 25/005 with embedded materials for reinforcement, e.g. wires, coils, braids
• CPC Class Codes: D04C 3/48 Auxiliary devices

Abstract

Tubular devices are provided that include a proximal end, a distal end sized for introduction into a patient'"'"'s body, a central lumen, a conductor extending between the proximal and distal ends adjacent the central lumen, reinforcement members including windings extending helically around the central lumen, and an outer jacket. The tubular device includes a first portion in which the conductor extends helically around the central lumen, and a second portion in which the conductor extends longitudinally and either a) all of the windings surround the central lumen and the conductor remains outside the windings, b) at least some of the windings pass between the central lumen and the conductor and at least some of the windings surround both the central lumen and the conductor, and c) all of the windings surround both the central lumen and the conductor. Methods for making such tubular devices are also provided.

Claims

1. A method for making a tubular body using a braiding apparatus comprising a primary mandrel source configured to direct a primary mandrel along a central axis, a plurality of horn gears movably mounted around the central axis in a predetermined arrangement such that the horn gears rotate about respective horn gear axes and carriers travel along a generally circular around the central axis during operation of the braiding apparatus, and a dispenser configured to direct a conductor towards the primary mandrel from one of a plurality of locations comprising a first location disposed adjacent one of the carriers, a second location aligned with a horn axis of one of the horn gears, a third location outside the generally circular path, and a fourth location adjacent the central axis within the generally circular path, the method comprising:

braiding a first portion of the primary mandrel by;

a) directing the primary mandrel along the central axis;

b) providing the dispenser at one of the plurality of locations;

c) directing the conductor from the dispenser towards the primary mandrel such that the conductor is disposed adjacent the first portion of the primary mandrel in a first configuration; and

d) wrapping reinforcement members from the horn gears around the first portion of the primary mandrel;

braiding a second portion of the primary mandrel by;

a) moving the dispenser to another of the plurality of locations;

b) directing the primary mandrel further along the central axis; and

c) directing the conductor from the dispenser towards the primary mandrel such that the conductor is disposed adjacent the first portion of the primary mandrel in a second configuration different than the first configuration;

d) wrapping reinforcement members from the horn gears around the second portion of the primary mandrel;

applying an outer jacket around the first and second portions of the primary mandrel and the reinforcement members; and

removing the primary mandrel to define a primary lumen.

2. The method of claim 1, further comprising:

braiding a third portion of the primary mandrel by;

a) moving the dispenser to yet another of the plurality of locations;

b) directing the primary mandrel further along the central axis; and

c) directing the conductor from the dispenser towards the primary mandrel such that the conductor is disposed adjacent the third portion of the primary mandrel in a third configuration different than the second configuration;

d) wrapping reinforcement members from the horn gears around the third portion of the primary mandrel.

3. The method of claim 1, further comprising:

braiding a third portion of the primary mandrel by;

a) moving the dispenser source back to the one of the plurality of locations when the first portion was braided;

b) directing the primary mandrel further along the central axis; and

c) directing the conductor from the dispenser towards the primary mandrel such that the conductor is disposed adjacent the third portion of the primary mandrel in a third configuration similar to the first configuration;

d) wrapping reinforcement members from the horn gears around the third portion of the primary mandrel.

4. The method of claim 1, wherein the first portion of the primary mandrel is braided with the dispenser at the first location such that the conductor is braided helically around the primary mandrel along with the reinforcement members.

5. The method of claim 4, wherein the second portion of the primary mandrel is braided with the dispenser at the second location such that the conductor extends substantially longitudinally along the central axis, and such that some of the reinforcement members surround both the primary mandrel and the conductor along the second portion and some of the reinforcement members are disposed between the primary mandrel and the conductor along the second portion.

6. The method of claim 4, wherein the second portion of the primary mandrel is braided with the dispenser at the third location such that the reinforcement members surround only the primary mandrel and the conductor remains outside the reinforcement members along the second portion.

7. The method of claim 4, wherein the second portion of the primary mandrel is braided with the dispenser at one of the second, third, and fourth locations such that the conductor extends substantially longitudinally along the central axis.

8. The method of claim 7, wherein the conductor remains outside the reinforcement members along the second portion.

9. The method of claim 7, wherein the conductor is at least partially braided into the reinforcement layer along the second portion.

10. The method of claim 7, wherein the conductor exits through the outer jacket adjacent the second portion after the outer jacket is applied.

11. The method of claim 7, wherein the first location is adjacent a first reinforcement carrying element such that the conductor is wrapped helically around the first portion immediately adjacent a first reinforcement member feeding from the first reinforcement carrying element.

12. The method of claim 7, wherein the conductor comprises a plurality of wires feeding from the dispenser such that the plurality of wires are wrapped helically around the first portion in the same direction adjacent one another.

13. The method of claim 1, further comprising:

directing a secondary mandrel along the central axis adjacent the primary mandrel,

wherein the secondary mandrel extends substantially parallel to the central axis along the second portion such that the secondary mandrel is offset about ninety degrees around a circumference of the second portion relative to the conductor.

14. The method of claim 13, wherein the reinforcement members are wrapped around the second portion such that at least some of the reinforcement members surround both the primary mandrel and the secondary mandrel.

15. The method of claim 14, wherein the reinforcement members are wrapped around the second portion such that at least some of the reinforcement members surround only the primary mandrel.

16. The method of claim 13, further comprising:

removing the secondary mandrel to define an auxiliary lumen;

inserting a steering element into the auxiliary lumen; and

coupling an end of the steering element adjacent the second portion while the steering element remains free to slide within the auxiliary lumen.

17. The method of claim 1, further comprising mounting a sensing element on the second portion, and electrically coupling the sensing element to the conductor.

18. A method for making a tubular body using a braiding apparatus comprising a primary mandrel source configured to direct a primary mandrel along a central axis, a plurality of horn gears movably mounted around the central axis in a predetermined arrangement such that the horn gears rotate about respective horn gear axes and carriers travel along a generally circular around the central axis during operation of the braiding apparatus, and a dispenser configured to direct an elongate member towards the primary mandrel from one of a plurality of locations comprising a first location disposed adjacent one of the carriers, a second location aligned with a horn axis of one of the horn gears, a third location outside the generally circular path, and a fourth location adjacent the central axis within the generally circular path, the method comprising:

braiding a first portion of the primary mandrel by;

a) directing the primary mandrel along the central axis;

b) providing the dispenser at one of the plurality of locations;

c) directing the elongate member from the dispenser towards the primary mandrel such that the elongate member is disposed adjacent the first portion of the primary mandrel in a first configuration; and

d) wrapping reinforcement members from the horn gears around the first portion of the primary mandrel;

braiding a second portion of the primary mandrel by;

a) moving the dispenser to another of the plurality of locations;

b) directing the primary mandrel further along the central axis; and

c) directing the elongate member from the dispenser towards the primary mandrel such that the elongate member is disposed adjacent the first portion of the primary mandrel in a second configuration different than the first configuration;

d) wrapping reinforcement members from the horn gears around the second portion of the primary mandrel;

applying an outer jacket around the first and second portions of the primary mandrel, the elongate member, and the reinforcement members; and

removing the primary mandrel to define a primary lumen.

19. A method for making a tubular body using a braiding apparatus comprising a primary mandrel source configured to direct a primary mandrel along a central axis, a plurality of horn gears movably mounted around the central axis in a predetermined arrangement such that the horn gears rotate about respective horn gear axes and carriers travel along a generally circular around the central axis during operation of the braiding apparatus, and a plurality of dispensers, each dispenser configured to direct a conductor elongate member towards the primary mandrel from one of a plurality of locations comprising a first location disposed adjacent one of the carriers, a second location aligned with a horn axis of one of the horn gears, a third location outside the generally circular path, and a fourth location adjacent the central axis within the generally circular path, the method comprising:

braiding a first portion of the primary mandrel by;

a) directing the primary mandrel along the central axis;

b) providing the dispensers at one of the plurality of locations;

c) directing the conductors member from the dispensers towards the primary mandrel such that the conductors are disposed adjacent the first portion of the primary mandrel in a first configuration; and

d) wrapping reinforcement members from the horn gears around the first portion of the primary mandrel;

braiding a second portion of the primary mandrel by;

a) moving the dispenser to another of the plurality of locations;

b) directing the primary mandrel further along the central axis; and

c) directing the conductors from the dispensers towards the primary mandrel such that the conductors are disposed adjacent the first portion of the primary mandrel in a second configuration different than the first configuration;

d) wrapping reinforcement members from the horn gears around the second portion of the primary mandrel;

applying an outer jacket around the first and second portions of the primary mandrel, the elongate member, and the reinforcement members; and

removing the primary mandrel to define a primary lumen.

20. The method of claim 19, wherein the first portion of the primary mandrel is braided with the dispensers at the first location such that the conductors are braided helically around the primary mandrel along with the reinforcement members.

21. The method of claim 20, wherein the second portion of the primary mandrel is braided with the dispensers at the second location such that the conductors extend substantially longitudinally along the central axis.

22. The method of claim 21, wherein the conductors exit through the outer jacket adjacent the second portion after the outer jacket is applied.

23. The method of claim 22, further comprising mounting a plurality of sensing elements on the second portion, and electrically coupling the sensing elements to respective conductors.