Balloon catheter with distal guide wire lumen

• US 5,522,818 A
• Filed: 08/30/1995
• Issued: 06/04/1996
• Est. Priority Date: 08/28/1990
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Keith, Peter T., Euteneuer, Charles L.
• Primary Examiner(s): Yasko, John D.
• Assistant Examiner(s): CERMAK, ADAM
• Application Number:
  US08/521,460
• Time in Patent Office: 279 Days
• Field of Search: 604/96-103, 604/280, 604/282, 606/192-196, 600/18, 128/207.15
• US Class Current: 604/103.09
• 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
• 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 2025/0098 having a strain relief at the proximal end, e.g. sleeve
• CPC Class Codes: A61M 2025/0183 Rapid exchange or monorail catheters
• CPC Class Codes: A61M 2025/09191 made of twisted wires
• CPC Class Codes: A61M 2025/1056 having guide wire lumens outside the main shaft, i.e. the guide wire lumen is within or on the surface of the balloon
• 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 2025/1079 having radio-opaque markers in the region of the balloon
• 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

An over-the-wire balloon dilatation catheter has a stainless steel hypotube catheter shaft, an intermediate sleeve section bonded to the shaft and a distal balloon section connected to the sleeve section. The sleeve section is formed from relatively flexible polymer materials and includes an inner core tube which defines a guide wire lumen extending only through a distal portion of the catheter (including its sleeve and balloon sections) to facilitate fast balloon catheter exchanges. A distal end of the hypotube shaft is crimped laterally and the core tube is nested and bonded within the crimp to provide a proximal outlet for the guide wire lumen. The hypotube shaft provides an inflation lumen for the balloon, with the inflation lumen being continued as an annular inflation lumen through the sleeve section where an outer sleeve is bonded about the core tube and extends from the distal end of the hypotube shaft to the balloon section. A kink-resistant coil structure extends distally from the distal end of the hypotube shaft to provide a gradual change in stiffness along the length of the catheter from the relatively stiff hypotube shaft to the relatively flexible distal portion of the catheter.

Claims

1. A catheter shaft assembly comprising:

a first thin-walled, high strength metallic tube structure having a lumen extending therethrough;

a second tube structure extending distally from the metallic tube, with the second tube structure being more flexible than the metallic tube structure and having a second lumen extending longitudinally therethrough which is in fluid communication with the first lumen;

a core tube disposed within the second tube and extending from proximate the proximal end of the second tube to a location distal the second tube, the core tube defining guidewire lumen having a proximal end and a distal end, and a guide wire lumen opening at each end of the guidewire lumen; and

means for preventing significant closure of the second lumen, the means for preventing significant closure being adjacent a distal end of the metallic tube structure when the more flexible second tube structure is bent laterally relative to the metallic tube structure, wherein the means for preventing closure comprises a coil member affixed to the second tube structure adjacent the distal end of the metallic tube structure.

2. The catheter shaft assembly of claim 1, and further comprising:

an inner core tube extending coaxially through at least a portion of the first lumen and through the second lumen.

3. A balloon dilatation catheter comprising:

a thin-walled, high strength metallic tube having a longitudinal inflation lumen extending therethrough from its proximal end to its distal end;

an inner core tube having proximal and distal end and a longitudinal guidewire lumen extending therethrough, the proximal end of the core tube being disposed proximate the distal end of the metallic tube;

an intermediate sleeve section extending distally from the metallic tube, the sleeve section being more flexible than the metallic tube, and including an outer sleeve which extends over a proximal segment of the core tube to define an annular inflation lumen therebetween that is in fluid communication with the inflation lumen of the metallic tube, with the guide wire lumen having an outlet at a proximal end of the proximal segment of the core tube and an inlet at a distal end of the core tube, the core tube having a distal segment which extends distally beyond a distal end of the outer sleeve to the guidewire lumen inlet;

means for exposing the guide wire lumen outlet at the proximal end of the core tube to an exterior of the catheter without compromising the integrity of the inflation lumens extending through the catheter, the outlet being adjacent and proximal to the distal end of the metallic tube ;

an inflatable balloon extending over the distal segment of the core tube, the balloon having its proximal end connected to the distal end of the outer sleeve and having its distal end connected to the core tube so that an interior of the balloon is in fluid communication with the annular inflation lumen in the intermediate sleeve section; and

means for preventing significant closure of the guide wire lumen and annular inflation lumen in the intermediate sleeve section, the means for preventing significant closure being adjacent the distal end of the metallic tube when the more flexible intermediate sleeve section is bent laterally relative to the metallic tube.

4. The balloon dilatation catheter of claim 3 wherein the means for preventing closure comprises a coil member affixed to the intermediate sleeve section adjacent the distal end of the metallic tube.

5. The balloon dilatation catheter of claim 4 wherein the coil member is affixed about the outer sleeve to extend distally from the metallic tube.

6. The balloon dilatation catheter of claim 5 wherein the coil member has its coils spaced increasingly apart as it ends distally from the metallic tube.

7. The balloon dilatation catheter of claim 3 wherein the metallic tube has an aperture therethrough at a point spaced proximally from its distal end, and wherein the proximal end of the inner tube is bonded to the metallic tube so that the outlet of the guide wire lumen is aligned with the aperture.

8. A balloon dilatation catheter comprising:

a first thin-walled, high strength, relatively inflexible tube having a longitudinal inflation lumen extending therethrough from its proximal end to its distal end, the first tube having, at the distal end thereof, a longitudinal crimp extending laterally inwardly from one side of the first tube with the crimp having a proximal transition region and a distal bonding region;

a second relatively flexible core tube having a longitudinal guide wire lumen extending therethrough from its proximal end to its distal end, with the proximal end of the second tube being nested within the distal bonding region of the longitudinal crimp of the first tube and bonded thereto so that the second tube extends distally from the first tube, the core tube defining a guidewire lumen outlet at the proximal end of the core tube and a guidewire lumen inlet at the distal end of the core tube; and

a balloon assembly having an elongated proximal waist segment, an intermediate expandable segment and a distal waist segment, the proximal segment extending over at least a distal portion of the bonding region and sealably affixed thereabout so that the inflation lumen is in fluid communication with an interior of the balloon assembly through the proximal segment, with the balloon assembly extending distally from the bonding region over the second tube to a second bonding region where the distal waist segment is sealably affixed about the second tube.

9. The balloon dilatation catheter of claim 8, and further comprising:

means for preventing significant closure of the interior of the proximal waist segment of the balloon assembly, the means for preventing significant closure being adjacent the distal end of the first tube when the proximal waist segment is bent laterally relative to the first tube.

10. The balloon dilatation catheter of claim 9 wherein the means for preventing closure comprises a coil member affixed about at least a proximal portion of the proximal waist segment over and distally adjacent to the bonding region.

11. A balloon dilatation catheter comprising:

a first thin-walled, high strength, relatively inflexible tube having a longitudinal inflation lumen extending therethrough from its proximal end to its distal end, the first tube having, at the distal end thereof, a longitudinal crimp extending laterally inwardly from one side of the first tube with the crimp having a proximal transition region and a distal bonding region;

a second relatively flexible core tube having a longitudinal guide wire lumen extending therethrough from its proximal end to its distal end, with the proximal end of the second tube being nested within the distal bonding region of the longitudinal crimp of the first tube and bonded thereto so that the second tube extends distally from the first tube, the core tube defining a guidewire lumen outlet at the proximal end of the core tube and a guidewire lumen inlet at the distal end of the core tube;

a sleeve having a proximal end and a distal end, the sleeve proximal end being sealably affixed about the bonding region with the sleeve extending distally from the first tube and about the second tube to define a longitudinal annular inflation lumen between the sleeve and the second tube, and with the annular inflation lumen being in fluid communication with the inflation lumen in the fist tube;

a balloon having a proximal waist, an intermediate expandable segment and a distal waist, the proximal waist being sealably affixed to a distal end of the sleeve so that an interior of the balloon is in fluid communication with the annular inflation lumen, the balloon extending distally from its proximal end about the second tube and with the distal waist of the balloon sealably affixed about the distal end of the core tube; and

means for preventing significant closure of the annular inflation lumen and guide wire lumen in a portion of the catheter just distally of the distal end of the first tube when that portion is bent laterally relative to the first tube, the means for preventing closure being disposed at the portion of the catheter bent laterally relative to the first tube.