Dilatation balloon catheter

• US 4,943,278 A
• Filed: 02/29/1988
• Issued: 07/24/1990
• Est. Priority Date: 02/29/1988
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Mattison, Richard C., Keith, Peter T., Hektner, Thomas R., Adams, Daniel O., Euteneuer, Charles L.
• Primary Examiner(s): Yasko, John D.
• Assistant Examiner(s): DeFranco, Denise W.
• Application Number:
  US07/162,004
• Time in Patent Office: 876 Days
• Field of Search: 128/344, 128/348.1, 128/325, 604/96, 604/97, 604/102, 604/122, 606/191, 606/194
• US Class Current: 606/194
• 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 2025/0063 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 25/0054 with regions for increasing flexibility
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A balloon catheter for use in angioplasty includes an elongated flexible thin walled metal tube which carries an inflatable balloon at its distal end. A 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.

Claims

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

an elongate flexible tubular member having an interior passage extending from a proximal end to a distal end, the tubular member having a longitudinally extending bonding region formed in a portion of a side wall of the tubular member adjacent to its distal end;

a core member having a smaller outer diameter than the tubular member, the core member having a proximal end positioned in the bonding region and bonded to the tubular member and the core member extending distally beyond the distal end of the tubular member;

an inflatable balloon member having a first end bonded to the proximal end of the core member and to the distal end of the tubular member and having a second end connected to the core member, the balloon member extending around the core member and having an interior in fluid communication with the interior passage of the tubular member; and

wherein the core member has a vent passage which extends between a vent opening in communication with the interior of the balloon member and an exterior opening proximate the proximal end of the core member.

2. The catheter of claim 1 wherein the balloon member has a proximal waist segment, an intermediate balloon segment, and a distal segment.

3. The catheter of claim 2 wherein the vent opening is positioned near a proximal end of the balloon segment.

4. The catheter of claim 2 wherein the vent opening is positioned near a distal end of the balloon segment.

5. The catheter of claim 1 wherein the core member extends through the second end of the balloon member.

6. The catheter of claim 5 wherein the core member has a spring tip attached at its distal end.

7. The catheter of claim 6 wherein the spring tip has a proximal portion surrounding and bonded to the core member, and wherein the second end of the balloon member surrounds and is bonded to the proximal portion of the spring tip.

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

an elongate flexible tubular member having an interior passage extending from a proximal end to a distal end, the tubular member having a longitudinally extending bonding region formed in a portion of a side wall of the tubular member adjacent to tis distal end, the bonding region being defined by a longitudinal slot which opens at the distal end of the tubular member;

a core member having a smaller outer diameter than the tubular member, the core member having a proximal end positioned in the bonding region and bonded to the tubular member and the core member extending distally beyond the distal end of the tubular member; and

an inflatable balloon member having a first end connected to the distal end of the tubular member and having a second end connected to the core member, the balloon member extending around the core member and having an interior in fluid communication with the interior passage of the tubular member

9. The catheter of claim 8 wherein the longitudinal slot is parallel to a central axis of the tubular member and the balloon member.

10. A balloon catheter comprising:

a catheter shaft formed by a thin-walled tube having a proximal end and a distal end, and having a longitudinally extending bonding region formed in a portion of a side wall of the shaft adjacent to its distal end;

a flexible tube section having a proximal segment connected to the distal end of the shaft, a distal segment, and an inflatable balloon segment therebetween; and

a core extending through the flexible tube section, the core having a distal end portion connected to the distal segment of the flexible tube section and a proximal end portion positioned in the bonding region of the shaft and bonded to the shaft at the bonding region, and with the core having a central vent passage which opens externally of the catheter proximate the proximal portion end of the core, and which opens to an interior of the balloon segment to permit purging of gas from the interior of the balloon segment into the central vent passage.

11. The catheter of claim 10 wherein the distal end of the shaft, the proximal segment of the flexible tube section and the proximal end portion of the core are attached together to form a fluid tight seal.

12. The balloon catheter of claim 10 wherein the core has a vent opening which is positioned near a proximal end of the balloon segment.

13. The balloon catheter of claim 10 wherein the core has a vent opening which si positioned near a distal end of the balloon segment.

14. The balloon catheter of claim 10 wherein the core includes a hollow proximal segment through which the vent passage extends and a solid distal segment joined t the proximal segment.

15. The balloon catheter of claim 10 and further comprising:

a spring tip attached to the distal end portion of the core.

16. The balloon catheter of claim 15 wherein the spring tip has a proximal portion surrounding and bonded to the core, and wherein the distal segment of the flexible tube section surrounds and is bonded to the proximal portion of the spring tip.

17. A balloon catheter comprising:

a catheter shaft formed by a thin-walled tube having a proximal end and a distal end, and having a longitudinally extending bonding region formed in a portion of a side wall of the shaft adjacent to its distal end, the bonding region being defined by a longitudinal slot which opens at the distal end of the shaft;

a flexible tube section having a proximal segment connected to the distal end of the shaft, a distal segment, and an inflatable balloon segment therebetween; and

a core extending through the flexible tube section, the core having a distal end portion connected to the distal segment of the flexible tube section and a proximal end portion positioned in the bonding region of the shaft and bonded to the shaft at the bonding region.

18. A balloon catheter comprising:

a catheter shaft having a proximal end, a distal end, and an inflation lumen extending therethrough; and

an inflatable balloon member connected to the distal end of the catheter shaft with an interior in communication with the inflation lumen; and

a core member having a proximal end connected to the distal end of the catheter shaft and a distal end connected to the balloon member, the core member having a vent passage which extends between a vent opening in communication with the interior of the balloon member and an exterior opening which opens to outside the catheter and which is located proximate the proximal end of the core member.

19. The balloon catheter of claim 18 wherein the vent opening is positioned near a proximal end of the balloon member.

20. The balloon catheter of claim 18 herein the vent opening is positioned near a proximal end of the balloon member.

21. The balloon catheter of claim 18 wherein the core member includes a hollow proximal segment through which the vent passage extends and a solid distal segment is joined to the proximal segment.

22. A self-venting balloon catheter comprising:

a catheter shaft having a proximal end, a distal end and an inflation lumen extending therethrough;

an inflatable balloon having a proximal end connected to the distal end of the catheter shaft at a bond therebetween, with an interior of the balloon in communication with the inflation lumen; and

a core member connected to the distal end of the catheter shaft and extending distally through the interior of the balloon member, the core member having a vent passage therein which opens to the interior of the balloon and to an exterior of the catheter for venting air from the interior of the balloon to outside the catheter adjacent the distal end of the catheter shaft but inhibiting escape of liquid from the balloon.

23. The self-venting balloon catheter of claim 22 wherein the core has a distal end bonded to the balloon member.

24. The self-venting balloon catheter of claim 22 wherein the core member has a vent opening which is positioned near the proximal end of the balloon member.

25. The self-venting balloon catheter of claim 22 wherein the core member has a vent opening which is positioned near a distal end of the balloon member.

26. The self-venting balloon catheter of claim 22 wherein the core member includes a hollow proximal segment through which the vent passage extends and a solid distal segment is joined to the proximal segment.

27. A method of making a balloon catheter comprising:

providing a thin-walled tube as a shaft;

forming a longitudinal slot in a portion of a side wall of the tube adjacent a distal end of the tube, with the slot being open at the distal end of the tube;

positioning a proximal end of a core member in the longitudinal slot;

bonding the proximal end of the core member to the tube; and

attaching an inflatable balloon member over the core member so that a proximal segment of the balloon member is connected to the tube and a distal segment of the balloon member is connected to the core member.

28. The method of claim 27 wherein forming the longitudinal slot is by electrodischarge machining.

29. The method of claim 27 and further comprising:

bonding a spring tip to a distal end of the core member.

30. The method of claim 29 wherein bonding a spring tip includes bonding a proximal portion of the spring tip around the core member, and wherein attaching an inflatable balloon includes bonding the distal segment of the balloon around the proximal portion of the spring tip.

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

an elongated flexible metal tube having a proximal end and a distal end, having a lumen extending therethrough from the proximal end to the distal end, and having a longitudinal slot formed in a side wall adjacent the distal end of the metal tube;

a flexible core member which is shorter than the metal tube, which has a smaller outer diameter than the metal tube, and which has a proximal end positioned in the longitudinal slot and bonded to the metal tube, the core member extending distally beyond the distal end of the metal tube to a distal end; and

a flexible tube section which includes a proximal waist segment, an intermediate balloon segment, and a distal segment, the proximal waist segment being connected at its proximal end to the distal end of the metal tube and the distal segment being connected to the core member;

the core member extending through the proximal waist segment, through the intermediate balloon segment and out the distal end of the distal segment; and

an interior of the inflatable balloon segment being in fluid communication with the lumen of the metal tube.