Fixed wire dilatation balloon catheter

• US 6,071,273 A
• Filed: 10/23/1991
• Issued: 06/06/2000
• Est. Priority Date: 02/29/1988
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Hektner, Thomas R., Mattison, Richard C., Keith, Peter T., Adams, Daniel O., Euteneuer, Charles L.
• Primary Examiner(s): Coggins, Wynn Wood
• Assistant Examiner(s): Sadula, Jennifer R
• Application Number:
  US07/782,242
• Time in Patent Office: 3,149 Days
• Field of Search: 604/95-103, 604/280, 604/281, 604/282, 604/523, 604/530, 604/524, 128/772, 128/657, 606/192, 606/193, 606/194, 606/196
• US Class Current: 604/523
• CPC Class Codes: A61M 2025/0034 characterized by elements which are assembled, connected or fused, e.g. splittable tubes, outer sheaths creating lumina or separate cores making of catheters A61M25/0009
• 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 2025/0079 Separate user-activated means, e.g. guidewires, guide tubes, balloon catheters or sheaths, for sealing off an orifice, e.g. a lumen or side holes, of a catheter
• CPC Class Codes: A61M 2025/0183 Rapid exchange or monorail catheters
• CPC Class Codes: A61M 2025/1061 having separate inflations tubes, e.g. coaxial tubes or tubes otherwise arranged apart from the catheter tube
• CPC Class Codes: A61M 2025/1077 having a system for expelling the air out of the balloon before inflation and use
• CPC Class Codes: A61M 2025/1093 having particular tip characteristics
• CPC Class Codes: A61M 25/0029 characterized by features relating to least one lumen located at the middle part of the catheter, e.g. slots, flaps, valves, cuffs, apertures, notches, grooves or rapid exchange ports catheter shaft surface irregularities A61M2025/006
• CPC Class Codes: A61M 25/0032 characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts
• CPC Class Codes: A61M 25/0054 with regions for increasing flexibility
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A fixed wire balloon catheter for use in angioplasty includes an elongated flexible thin walled metal tube which carries an inflatable balloon at its distal end. A metal core member of smaller outer diameter than the metal tube is attached to the distal end of the tube to provide support for and guiding of the balloon section. The proximal end of the balloon is connected either to the distal end of the metal tube or to an intermediate waist tube, with the core extending distally from the metal tube through the balloon. The distal end of the balloon is secured to the core. A vent arrangement is provided to purge the catheter of gases prior to use.

Claims

1. A guiding member for advancement within a patient'"'"'s vascular system, comprising:

a main tubular member which has proximal and distal ends and which has an inner lumen extending therethrough to an opening in the distal end thereof;

a tubular extension, more flexible than the main tubular member, which has a proximal end, a distal end and an inner lumen and which is secured by the proximal end thereof to the distal end of the main tubular member;

an elongated core member which extends through the inner lumen of the tubular extension and which has a proximal portion overlapping and secured to the main tubular member near the distal end of the main tubular member in an overlapping region such that a passageway is formed within the main tubular member along the overlapping region, external to the core member to provide fluid communication between the inner lumen of the main tubular member and the inner lumen of the tubular extension, the core member having a distal portion which extends out the distal end of the tubular extension; and

a flexible body which is disposed about and secured to the distal portion of the core member and which has a distal tip positioned distally from where the proximal end of the tubular extension is secured to the main tubular member.

2. The guiding member of claim 1 wherein the proximal end of the core member extends within the inner lumen of the main tubular member, along the overlapping region.

3. The guiding member of claim 1 wherein the proximal end of the core member extends exterior to the inner lumen of the main tubular member, along the overlapping region.

4. A guiding member for advancement within a patient'"'"'s vascular system, comprising:

a main tubular member which has proximal and distal ends, a central axis and an inner lumen extending therethrough to an opening in the distal end thereof;

a tubular extension, more flexible than the main tubular member, which has a proximal end, a distal end and an inner lumen and which is secured by the proximal end thereof to the distal end of the main tubular member;

an elongated core member which extends through the inner lumen of the tubular extension and which has a proximal end secured to the main tubular member, nearer the distal end of the main tubular member than the proximal end, wherein a central axis of the core member is offset with respect to the central axis of the main tubular member such that the inner lumen of the main tubular member communicates with the inner lumen of the tubular extension, the core member having a distal end extending out the distal end of the tubular extension; and

a flexible body which is disposed about and secured to the distal end of the core member.

5. The guiding member of claim 4 wherein the proximal end of the core member extends within the inner lumen of the main tubular member.

6. The guiding member of claim 4 wherein the proximal end of the core member extends exterior to the inner lumen of the main tubular member.

7. A catheter for use in angioplasty, the catheter comprising:

an elongate flexible tubular member having a central axis, a proximal end, a distal end and an interior passageway extending from the proximal end to the distal end;

a core member having a smaller outer diameter than the interior passageway of the tubular member and having a proximal end and a distal end, the core member having a central axis offset with respect to the central axis of the tubular member and bonded to a side wall of the tubular member, nearer the distal end of the tubular member than the proximal end, with the core member extending distally beyond the distal end of the tubular member;

an elongate flexible waist tube sealably connected to the tubular member, the waist tube extending distally beyond the distal end of the tubular member about the core member to define a distal interior passage in fluid communication with the interior passage of the tubular member, with the distal end of the waist tube terminating proximally of the distal end of the core member; and

an inflatable balloon member having a proximal end sealably connected to the distal end of the waist tube and having a distal end sealably connected to the core member, with the balloon member extending around a portion of the core member and having an interior in fluid communication with the distal interior passage of the waist tube.

8. A guiding member for advancement within a patient'"'"'s vascular system, comprising;

a main tubular member which has proximal and distal ends and which has an inner lumen extending therethrough to an opening in the distal end thereof;

a tubular extension more flexible than the main tubular member which has an inner lumen and which is secured by the proximal end thereof to the distal end of the main tubular member;

an elongated core member which has a proximal end secured within the inner lumen of the main tubular member at a location proximal to the distal end of the main tubular member and a substantial distance distal to the proximal end thereof and which extends out the opening in the distal end thereof, through the inner lumen of the tubular extension and out the distal end of the tubular extension, an adjacent passageway defined between the portion of the core member disposed within the inner lumen of the main tubular member and an inner wall of the main tubular member; and

a flexible body which is disposed about and secured to a portion of the core member extending out the distal end of the tubular extension.

9. The guiding member of claim 8 wherein the main tubular member is made of metallic material.

10. The guiding member of claim 9 wherein the metallic material includes stainless steel.

11. The guiding member of claim 8 in the form of a dilatation catheter with an inflatable dilatation balloon provided on a distal portion thereof.

12. The guiding member of claim 11 wherein the core member extends through the interior of the balloon and out the distal end thereof and the distal end of the balloon is sealingly bonded to the portion of the core member which extends therethrough.

13. The guiding member of claim 11 wherein the balloon is flexible but relatively inelastic.

14. The guiding member of claim 8 wherein the flexible body disposed about the portion of the core member which extends out the distal end of the tubular extension is a helical coil having a rounded plug on the distal end thereof.

15. The guiding member of claim 8 wherein the core member and the tubular extension are secured to the main tubular member in a region.

16. The guiding member of claim 15 wherein the region is about 25 to about 60 cm proximal to the distal tip of the flexible body.

17. The guiding member of claim 8 wherein the tubular extension is formed of a plastic material.

18. A guiding member for advancement within a patient'"'"'s vascular system, comprising:

a main tubular member which has proximal and distal ends and which has an inner lumen extending therethrough to an opening in the distal end thereof;

a tubular extension more flexible than the main tubular member which has an inner lumen and which is secured by the proximal end thereof to the distal end of the main tubular member;

an elongated core member which has a proximal end secured to the main tubular member at a location proximal to the distal end of the main tubular member and a substantial distance distal to the proximal end thereof and which extends from the distal end thereof, through the inner lumen of the tubular extension and out the distal end of the tubular extension, the portion of the core member secured to the main tubular member so as to define an adjacent passageway; and

a flexible body which is disposed about and secured to a portion of the core member extending out the distal end of the tubular extension.