System and method for manufacturing variable stiffness catheters

• US 10,426,917 B2
• Filed: 04/14/2016
• Issued: 10/01/2019
• Est. Priority Date: 04/16/2015
• Status: Active Grant

• Current Assignee: Stryker European Operations Holdings, LLC (Stryker Corporation)
• Original Assignee: Stryker Corporation
• Inventors: Porter, Stephen
• Primary Examiner(s): Tucker, Philip C
• Assistant Examiner(s): Slawski, Brian R
• Application Number:
  US15/099,458
• Publication Number:
  US 20160303347A1
• Time in Patent Office: 1,265 Days
• Field of Search: 156 60, 156 64, 156150, 156166, 156167, 156169, 156172, 156173, 156175, 156180, 156181, 156242, 15624411, 15624412, 15624413, 1563082, 1563096, 156349, 156350, 156356, 156359, 156367, 156378, 156391, 156392, 156425, 156428, 156429, 156430, 156431, 156432, 156443, 156446, 156448, 156500
• CPC Class Codes: A61M 25/00 Catheters; Hollow probes dilators A61M29/00; peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00 ; for measuring or testing A61B; materials for catheters A61L29/00
• CPC Class Codes: A61M 25/0012 with embedded structures, e.g. coils, braids, meshes, strands or radiopaque coils
• CPC Class Codes: A61M 25/0053 having a variable stiffness along the longitudinal axis, e.g. by varying the pitch of the coil or braid
• CPC Class Codes: B29C 2948/9258 Velocity
• CPC Class Codes: B29C 2948/9259 Angular velocity
• CPC Class Codes: B29C 2948/926 Flow or feed rate
• CPC Class Codes: B29C 2948/92828 Raw material handling or dosing, e.g. active hopper or feeding device
• CPC Class Codes: B29C 2948/92876 Feeding, melting, plasticising or pumping zones, e.g. the melt itself
• CPC Class Codes: B29C 48/0019 combined with shaping by flattening, folding or bending
• CPC Class Codes: B29C 48/05 Filamentary, e.g. strands
• CPC Class Codes: B29C 48/154 Coating solid articles, i.e. non-hollow articles
• CPC Class Codes: B29C 48/157 Coating linked inserts, e.g. chains
• CPC Class Codes: B29C 48/286 Raw material dosing
• CPC Class Codes: B29C 48/2886 of fibrous, filamentary or filling materials, e.g. thin fibrous reinforcements or fillers
• CPC Class Codes: B29C 48/30 Extrusion nozzles or dies extrusion characterised by the shape or cross-section of the extruded article B29C48/03
• CPC Class Codes: B29C 48/92 Measuring, controlling or regulating
• CPC Class Codes: B29C 53/566 for making tubular articles followed by compression
• CPC Class Codes: B29C 53/66 with axially movable winding feed member , e.g. lathe type winding
• CPC Class Codes: B29C 65/18 using heated tools
• CPC Class Codes: B29C 66/69 General aspects of joining filaments bundling articles B65B13/00; interconnecting successive lengths of material B65H69/00
• CPC Class Codes: B29C 66/9141 : by controlling or regulating the temperature
• CPC Class Codes: B29C 66/93411 : the parts to be joined having different speeds
• CPC Class Codes: B29C 66/93451 : by controlling or regulating the rotational speed, i.e. the speed of revolution
• CPC Class Codes: B29L 2031/7542 : Catheters

Abstract

A system for manufacturing a catheter includes at least first and second controllable rate material feeders that feed at least first and second materials into a temperature-controlled mixer to form a compound material that varies in flexibility and/or strength with the respective first and second materials and material feed rates. An extruder extrudes the compound material onto a rotating and translating mandrel to thereby form a variable stiffness profile along a length of the catheter that depends on respective rates of rotation and translation of the mandrel.

Claims

1. A system for manufacturing a catheter, comprising:

a first material feeder coupled to a first material source;

a second material feeder coupled to a second material source;

a thermally controlled mixer coupled to the first and second material feeders, wherein the first material feeder is configured to feed a first material from the first material source into the mixer at a first material feed rate, and the second material feeder is configured to feed a second material from the second material source into the mixer at a second material feed rate, such that the first and second materials are combined in the mixer to form a compound material that varies in content as a function of the respective first and second materials, and of the first and second material feed rates;

a catheter formation mandrel having a longitudinal axis, the mandrel being controllably rotatable about the longitudinal axis at a mandrel rotation rate;

an extruder operatively coupled to the mixer and having an output nozzle configured to apply compound material from the mixer onto the catheter formation mandrel; and

a control system comprising one or more processors that control one or more of the first material feed rate, second material feed rate, and mandrel rotation rate, respectively, so as to enable formation of a catheter having a variable stiffness profile along a length of the catheter,

wherein the extruder is configured to apply an extrusion of compound material from the mixer onto the catheter formation mandrel such that the extrusion winds around the mandrel forming adjacent loops of compound material on the catheter formation mandrel.

2. The catheter manufacturing system of claim 1, the first and second materials having different elasticity and/or strength characteristics, wherein an elasticity and/or strength of the compound material may be varied by controlling one or both of the first and second material feed rates.

3. The catheter manufacturing system of claim 1, the mixer comprising a heated mixing chamber, wherein the control system controls a temperature of the mixing chamber.

4. The catheter manufacturing system of claim 1, wherein the extruder applies the compound material onto the catheter formation mandrel at a material extrusion rate controlled by the control system independently of the respective first and second material feed rates.

5. The catheter manufacturing system of claim 4, the extruder and/or output nozzle being translatable along the longitudinal axis of the catheter formation mandrel at an extruder translation rate controlled by the control system.

6. The catheter manufacturing system of claim 5, wherein the control system varies a wall thickness along a length of at least a portion of a catheter being formed on the mandrel by varying one or more of the first material feed rate, second material feed rate, mandrel rotation rate, and extruder translation rate.

7. The catheter manufacturing system of claim 5, wherein the control system adjusts one or more of the first material feed rate, second material feed rate, mandrel rotation rate, and extruder translation rate based on real-time measurement data of a diameter of a portion of a catheter being formed on the mandrel.

8. The catheter manufacturing system of claim 5, further comprising two or more heating elements disposed adjacent or otherwise in proximity to a location at which the extruder applies the compound material onto the mandrel, the two or more heating elements comprising

a first heating element disposed on a first side of the mandrel adjacent or otherwise in proximity to a location at which the extruder applies the compound material onto the mandrel, and

a second heating element disposed on an opposing side of the mandrel from the first heating element.

9. The catheter manufacturing system of claim 8, wherein the two or more heating elements are coupled to, so as to translate along the mandrel with, the extruder and/or output nozzle.

10. The catheter manufacturing system of claim 1, further comprising a third material feeder coupled to a third material source, wherein the third material feeder is configured to feed a third material from the third material source into the mixer at a third material feed rate controlled by the system controller, such that the first, second and third materials are combined in the mixer to form the compound material, and wherein the compound material varies in content as a function of the respective first, second and third materials, and of the first, second and third material feed rates.

11. The catheter manufacturing system of claim 1, further comprising a third material feeder coupled to a source of material having a higher melting point than said compound material, wherein the third material feeder is configured to feed the material having a higher melting point than said compound material through or alongside the output nozzle with the compound material onto the catheter formation mandrel.