Catheter shaft with coextruded stiffener

• US 6,855,137 B2
• Filed: 03/07/2002
• Issued: 02/15/2005
• Est. Priority Date: 03/07/2002
• Status: Expired due to Fees

• Current Assignee: Myelotec Incorporated
• Original Assignee: Visionary BioMedical, Inc.
• Inventors: Bon, Edwin
• Primary Examiner(s): Lucchesi, Nicholas D.
• Assistant Examiner(s): WILLIAMS, CATHERINE SERKE
• Application Number:
  US10/093,757
• Publication Number:
  US 20030171736A1
• Time in Patent Office: 1,076 Days
• Field of Search: 604/510, 604/95.04, 604/164.13, 604/524, 604/525, 604/528, 600/434, 264/514, 264/515, 264/516, 264/541, 26417126-17129, 2641721-17215, 26417311-17317, 264/177.1
• US Class Current: 604/525
• CPC Class Codes: A61M 2025/0063 having means, e.g. stylets, mandrils, rods or wires to reinforce or adjust temporarily the stiffness, column strength or pushability of catheters which are already inserted into the human body
• CPC Class Codes: A61M 25/0012 with embedded structures, e.g. coils, braids, meshes, strands or radiopaque coils
• CPC Class Codes: A61M 25/0054 with regions for increasing flexibility
• CPC Class Codes: A61M 25/0141 having flexible regions as a result of using materials with different mechanical properties
• CPC Class Codes: A61M 25/0144 having flexible regions as a result of inner reinforcement means, e.g. struts or rods
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires

Abstract

A steerable catheter having a shaft with one or more internal stiffeners coextruded within the shaft along a portion of its length. The internal stiffeners have a higher or lower hardness than the body of the catheter shaft. The overall stiffness of the shaft varies along its length for improved steerability.

Claims

1. A steerable catheter comprising:

a handle comprising at least one steering actuator;

a catheter shaft having a proximal end connected to the handle, a distal end opposite the proximal end, and defining a length between said proximal and distal ends, said catheter shaft comprising at least steering wire lumen;

at least one steering wire extending through said at least one steering wire lumen of the catheter shaft and connected to said steering actuator;

two instrument lumens extending along the length of the catheter shaft, each of said two instrument lumens having a central axis lying on a first plane being extending through said catheter shaft; and

two stiffeners coextruded within said catheter shaft and extending along at least a portion of the length of the catheter shaft, each of said two stiffeners having a central axis lying on a second plane extending through said catheter shaft, the second plane being generally perpendicular to the first plane.

2. The steerable catheter of claim 1, wherein a steering wire lumen extends through each stiffener.

3. The steerable catheter of claim 1, wherein each stiffener has a first dimension in a direction parallel to said first plans, and a second dimension in a direction parallel to said second plane, and wherein said first dimension is greater than said second dimension.

4. The steerable catheter of claim 3, wherein said first dimension is at least twice said second dimension.

5. The steerable catheter of claim 1, wherein the stiffeners have a higher hardness than the catheter shaft.

6. The steerable catheter of claim 1, wherein the catheter shaft has a higher hardness than the stiffeners.

7. The steerable catheter of claim 1, wherein the stiffeners extend through less than the entire length of the catheter shaft.

8. A method of forming a catheter shaft, said method comprising:

extruding a first polymeric material to form a shaft body, the first polymeric material having a first hardness;

coextruding a second polymeric material to form two stiffeners within the shaft body, the second polymeric material having a second hardness different from the first hardness;

wherein at least one of said stiffeners is sequentially coextruded from said second polymeric material and a third polymeric material, said third polymeric material having a third hardness different from the first and second hardnesses; and

wherein the shaft body has at least one steering wire extending through at least one steering wire lumen of the shaft body and two instrument lumens extending along the length of the shaft body, each of said two instruments lumens having a central axis lying on a first plane extending through said shaft body, and said two stiffeners extending along at least a portion of the length of the shaft body, each of said two stiffeners having a central axis lying on a second plane extending through said shaft body, the second plane being generally perpendicular to the first plane.

9. The method of claim 8, wherein the first polymeric material has a higher hardness than the second polymeric material.

10. The method of claim 8, wherein the second polymeric material has a higher hardness than the first polymeric material.

11. The method of claim 8, wherein the at least one stiffener is coextruded within only a portion of the length the shaft body.

12. The method of claim 8, wherein the at least one stiffener is coextruded into the shaft body at a distance from a central longitudinal axis of the shaft body.

13. The method of claim 8, wherein the at least one stiffener is coextruded to have a cross sectional length and a cross sectional width, said cross sectional length being greater than said cross sectional width.