METHODS OF DIMENSIONALLY STABILIZING A LUMEN OF A MULTI-LUMEN DEVICE DURING MANUFACTURE

• US 20150306806A1
• Filed: 04/25/2014
• Published: 10/29/2015
• Est. Priority Date: 04/25/2014
• Status: Active Grant

• Current Assignee: Medtronic Ablation Frontiers LLC (Medtronic Plc)
• Original Assignee: Medtronic Ablation Frontiers LLC (Medtronic Plc)
• Inventors: DANDO, Jeremy D., HORRIGAN, John B., JANNICKE, Jeffrey J., PURCELL, Neil
• Granted Patent: US 9,505,159 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61M 25/0009 Making of catheters or other medical or surgical tubes
• CPC Class Codes: A61M 25/0012 with embedded structures, e.g. coils, braids, meshes, strands or radiopaque coils
• CPC Class Codes: A61M 25/0026 Multi-lumen catheters with stationary elements catheter assemblies comprising a catheter in combination with a guide tube, sheath or sleeve A61M2025/0681; catheters comprising telescoping coaxial elements A61M2025/0175
• CPC Class Codes: B29C 2948/92514 Pressure
• CPC Class Codes: B29C 2948/92904 Die; Nozzle zone
• CPC Class Codes: B29C 2948/92923 Calibration, after-treatment or cooling zone
• CPC Class Codes: B29C 48/10 flexible, e.g. blown foils
• CPC Class Codes: B29C 48/11 comprising two or more partially or fully enclosed cavities, e.g. honeycomb-shaped
• CPC Class Codes: B29C 48/12 Articles with an irregular circumference when viewed in cross-section, e.g. window profiles
• CPC Class Codes: B29C 48/154 Coating solid articles, i.e. non-hollow articles
• CPC Class Codes: B29C 48/156 Coating two or more articles simultaneously
• CPC Class Codes: B29C 48/16 Articles comprising two or more components, e.g. co-extruded layers
• CPC Class Codes: B29C 48/21 the layers being joined at their surfaces
• CPC Class Codes: B29C 48/267 Intermediate treatments, e.g. relaxation, annealing or decompression step for the melt B29C48/76 takes precedence
• CPC Class Codes: B29C 48/902 internally
• CPC Class Codes: B29C 48/919 using a bath, e.g. extruding into an open bath to coagulate or cool the material
• CPC Class Codes: B29C 48/92 Measuring, controlling or regulating
• CPC Class Codes: B29C 49/783 blowing pressure
• CPC Class Codes: B29K 2101/12 Thermoplastic materials
• CPC Class Codes: B29K 2995/0056 Biocompatible, e.g. biopolymers or bioelastomers
• CPC Class Codes: B29L 2031/7542 : Catheters

Abstract

A method of dimensionally stabilizing a lumen of a multi-lumen device during manufacture wherein one or more minor lumens may contain a fluid that maintains patency of the one or more minor lumens without the need for a solid core within. The at least one second lumen tube may be in fluid communication with a fluid source during the manufacturing process, such as during extrusion and/or mesh overlay steps. Preventing collapse of the one or more minor lumens during manufacture using a fluid instead of a solid core allows the lumens to have any of a variety of shapes and configurations that would be difficult, cost prohibitive, or impossible for a solid core to be used. Also, obviating the need for a solid core within one or more lumens reduces cost and production complexity. The fluid may be a non-compressible liquid or a pressurized gas.

Claims

1. A method for producing a multi-lumen medical device, the method comprising:

extruding at least one layer of material to form an elongate body with a first lumen and a second lumen, the first lumen having a removable core composed of a solid therein and the second lumen having a fluid therein during extrusion of the at least one layer of material.

2. The method of claim 1, wherein the device includes a plurality of second lumens, each of the plurality of second lumens having a fluid therein.

3. The method of claim 1, wherein the fluid is a non-compressible liquid.

4. The method of claim 3, wherein the non-compressible liquid is one of water, a mixture of water and isopropyl alcohol, silicone fluid, and combination thereof.

5. The method of claim 4, wherein the device includes a plurality of second lumens, each second lumen containing a non-compressible liquid.

6. The method of claim 1, wherein the fluid is a pressurized gas.

7. The method of claim 6, wherein the pressurized gas is one of atmospheric air, nitrogen, or combination thereof.

8. The method of claim 7, wherein extruding at least one layer of material to form an elongate body includes extruding a layer of first material to define an elongate body having a first lumen and a second lumen and extruding a layer of second material over the layer of first material.

9. The method of claim 8, the method further comprising depositing a mesh layer over the layer of first material.

10. The method of claim 9, wherein the pressurized gas has a first pressure during extruding the layer of first material, and the pressurized gas has a second pressure during depositing the mesh layer over the layer of first material and extruding the layer of second material over the mesh layer.

11. The method of claim 10, wherein the first pressure is less than the second pressure.

12. The method of claim 10, wherein the second lumen is in fluid communication with a source of pressurized gas, the source of pressurized gas being transitionable between delivering pressurized gas at the first pressure and pressurized gas at the second pressure.

13. The method of claim 10, wherein the second lumen is in fluid communication with a first source of pressurized gas delivering pressurized gas at the first pressure and is in fluid communication with a second source of pressurized gas delivering gas at the second pressure.

14. The method of claim 1 wherein the first layer of material defines the first and second lumens.

15. The method of claim 1, wherein the first layer of material is extruded over a first lumen tube defining the first lumen and a second lumen tube defining the second lumen, the second lumen tube being in fluid communication with a source of fluid.

16. A method of producing a multi-lumen elongate body for a medical device, the method comprising:

extruding a first layer of material over a first lumen tube and at least one second lumen tube to form an elongate body with a first lumen and at least one second lumen, the at least one second lumen tube being in fluid communication with a source of fluid, the source of fluid being one of;

pressurized gas; and

non-compressible liquid;

depositing a mesh layer over the elongate body;

extruding a second layer of material over the mesh layer.

17. The method of claim 16, wherein the first lumen tube contains a solid core, the solid core being removable.

18. The method of claim 16, wherein the at least one second lumen tube contains pressurized gas at a first pressure during the step of extruding a first layer of material and contains a pressurized gas at a second pressure during the steps of depositing a mesh layer over the elongate body and extruding a second layer of material over the mesh layer, the second pressure being greater than the first pressure.

19. The method of claim 17, wherein the at least one second lumen tube contains one of water, a mixture of water and isopropyl alcohol, silicone fluid, and combination thereof.

20. The method of claim 18, wherein the first lumen tube also contains pressurized gas at a first pressure during the step of extruding a first layer of material and contains a pressurized gas at a second pressure during the steps of depositing a mesh layer over the elongate body and extruding a second layer of material over the mesh layer, the second pressure being greater than the first pressure.

21. A method of producing a multi-lumen medical device, the method comprising:

providing a first lumen tube and providing at least one second lumen tube, each of the first lumen tube and the at least one second lumen tube being in fluid communication with a fluid source;

delivering fluid from the fluid source into the first lumen tube and the at least one second lumen tube;

extruding a first layer of material over the first lumen tube to form an elongate body having a length, a first lumen, and at least one second lumen;

depositing a mesh layer over the length of the elongate body; and

extruding a second layer of material over at least a portion of the mesh layer.

22. The method of claim 21, wherein the fluid source is compressed gas, the method further comprising:

delivering to the first lumen and the at least one second lumen compressed gas having a first pressure before the step of extruding a first layer of material;

delivering to the first lumen and the at least one second lumen compressed gas having a second pressure before the step of depositing a mesh layer over the length of the elongate body; and

delivering to the first lumen and the at least one second lumen compressed gas having the second pressure before the step of extruding a second layer of material over at least a portion of the mesh layer.