Dilation balloon

• US 4,906,241 A
• Filed: 03/18/1988
• Issued: 03/06/1990
• Est. Priority Date: 11/30/1987
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Corporation
• Inventors: Madenjian, Arthur R., Noddin, Richard A., DeMello, Richard M., Barry, Ralph J. Jr., de Toledo, Fernando A.
• Primary Examiner(s): Pellegrino, Stephen C.
• Application Number:
  US07/170,164
• Time in Patent Office: 718 Days
• Field of Search: 128/344, 128/325, 128/343, 128/348.1, 604/96-103
• US Class Current: 606/194
• CPC Class Codes: A61L 29/06 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61M 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 25/0133 Tip steering devices
• CPC Class Codes: A61M 25/1029 Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
• CPC Class Codes: A61M 25/104 used for angioplasty
• CPC Class Codes: C08L 67/02 Polyesters derived from dicarboxylic acids and dihydroxy compounds C08L67/06 takes precedence

Abstract

Dilation balloon devices that employ a metal tube for introduction of inflation fluid from distal end into a balloon have special features that enable introduction through very small passages. A distal core wire is shown forming part of a guide wire extending into the distal end of the tube. The core wire is fixed at the distal end of the tube, and has a proximal extension bridging across a fluid opening formed in the wall of the tube. The wire extension serves to transfer stress from the distal end of the device, across the fluid opening, to adjacent proximal portions of the tube, to prevent stress build-up at the opening that might lead to fracture of the tube during bending. In various embodiments, the device includes a bushing seal at the distal end of the balloon; a helical coil surrounds part or all of the length of the device, with strategic tapers along its length; a shrink tubing is used rather than a coil; and a pair of cross-wound multifilar coils are employed. A balloon having a very thin wall, even in its transition section, is formed from a specially prepared tubular preform.

Claims

1. In a dilatation balloon device comprising an inflatable balloon, and a main tubular member comprising a metal tube having distal and proximal ends, said inflatable balloon disposed adjacent the distal end of said main tubular member and in fluid flow connection therewith, said main tubular member adapted for introduction of inflation fluid from its distal end into said balloon,

a distal core wire forming part of a guide wire having a proximal end portion extending into the distal end of the tube, and a distal end portion extending within said balloon to a distal termination, said wire being fixed at the distal end of the tube and having a proximal extension bridging across a fluid opening defined in the wall of the tube, the wire extension serving to transfer stress from the distal end of the device, across the fluid opening, to proximally adjacent portions of the tube, thereby to prevent stress build-up at the opening that might lead to fracture of the tube during bending of the device.

2. The dilatation balloon device of claim 1 further comprising a balloon sleeve extending proximally of an expandible portion of said balloon, across said fluid opening to a point of attachment to the tube.

9. The dilatation balloon of claim 1, 6 or 7 wherein said wire extends to a distal tip of said device, the distal portion of said wire being of reduced diameter and more flexible relative to proximal portions thereof.

10. The dilatation balloon device of claim 1, 2, 3, 4, 5, 6 or 7 wherein helical coil means extend from the proximal region to the distal end of the device.

11. The dilatation balloon device of claim 1, 2, 3, 4, 5, 6 or 7 wherein a helical coil extends over a hollow liquid-tight tube from the proximal region of the device to the distal region of said main tubular body and a fluid impermeable sleeve extends from said distal region of said tubular body to said balloon.

12. The dilatation balloon device of claim 1, 2, 3, 4, 5, 6 or 7 wherein flexible polymeric tube means extend from the proximal region of the device to the proximal portion of said balloon.

13. The dilatation balloon of claim 1, 2, 3, 4, 5, 6 or 7 wherein said main tubular body comprises an exterior heat shrink tube shrunk upon a hollow metal liquid-conducting tube.

14. The dilatation balloon device of claim 1 or 7 wherein said balloon is the product of the process of blowing and drawing a preformed tubular member having a tapered contour in the region corresponding to the transition section of the blown balloon.

15. The dilatation balloon device of claim 14 wherein the preformed tubular member is the product of heating and drawing a defined region of an extruded tube of originally constant diameter and wall thickness.

16. The dilatation balloon device of claim 14 wherein the wall thickness of said tapering transition section is about the same as the wall thickness of the main body of the balloon.

17. The dilatation balloon catheter of claim 14 wherein the wall thickness of said tapering transition section is less than the wall thickness of the main body of the balloon.

18. The dilatation balloon catheter of claim 14 wherein the main body of said balloon has an inflated diameter of 5 mm or larger.

19. The dilatation balloon catheter of claim 14 wherein the resin from which the balloon is formed is polyethylene terephthalate.

20. The dilatation balloon device of claim 14 wherein an elongated sleeve extending proximally from said balloon past said inflation opening is formed integrally with said balloon as a result of drawing said tubular member.

21. The dilatation balloon device of claim 14 wherein said balloon has sleeves of smaller diameter than the original diameter tube from which the sleeves are formed.

3. A dilatation balloon device capable of being placed through any catheter that accepts an 0.038 inch diameter wire and capable of supporting a balloon having an inflated diameter up to about 4 mm diameter, said device comprising:

an inflatable balloon having a proximal and a distal end, said balloon being the product of the process of blowing and drawing a preformed tubular member having a tapered contour in the region corresponding to the transition section of the blown balloon,

a flexible elongated, torque transmitting hollow main tubular body of outside diameter of 0.038 inch or less, extending from a proximal region of the device to a position spaced from a distal end of the device, said inflatable balloon disposed adjacent the distal end of said main tubular member and in fluid flow connection therewith, said main tubular body having a distal portion and defining an interior volume adapted to conduct inflation liquid for said balloon,

flexible spanning structure extending distally from the fluid passage for communication between the distal portion of said main tubular body and the balloon, and including a torque-transmitting element that extends that extends from the main tubular body to a sealing formation at the distal end of the balloon,

the portion of said spanning structure that corresponds with the length of the balloon having an outer diameter no greater than about 0.025 inch, enabling the balloon to be collapsed to a profile of about 0.038 inch diameter or smaller,

the effective outer diameter of said spanning structure at said sealing formation being about 0.025 inch, to which a distal sleeve of the balloon is joined, and

a flexible, torqueable guide element extending distally from said sealing formation to the end of the device.

4. The dilatation balloon device of claim 3 wherein said hollow main tubular body includes a hollow metal tube, said torque transmitting element comprises a solid cross-section core wire joined to the distal end of said main tubular body and extending through said balloon to said sealing formation, said sealing formation including a solid annular member sealed to said wire for providing support for a distal sleeve of said balloon of substantially larger diameter than said wire.

5. The dilatation balloon device of claim 3 wherein a helical coil is joined to an outer surface of said sealing formation and extends distally therefrom to provide a flexible distal tip, the sleeve of the balloon being joined to an outer surface of said helical coil at said sealing formation.

6. The dilatation balloon device of claim 3 wherein said hollow main tubular body includes a hollow metal tube, said torque transmitting element comprises a solid cross-section core wire joined to the distal end of said main tubular body and extending through said balloon to said sealing formation, and wherein said main tubular member has a first outer diameter for most of its length and a second, reduced outer diameter portion at its distal end, the inner diameter of a region of the second, reduced outer diameter corresponding to the outer diameter of the core wire over a joint region at which said main tubular member and said solid cross-section wire are joined, said main tubular member having a fluid opening proximal of said joint region and said solid cross-section wire having a proximal portion spanning across said opening and extending proximally thereof, adapted to transfer stress from distal of said main tubular member to a portion of said main tubular member proximal of said opening, there being a flow path for inflation fluid to said opening within said main tubular member in a space defined at its inner periphery by an external surface of a proximal portion of said solid cross-section wire.

8. The dilatation balloon device of claim 6 or 7 wherein said main tubular member tapers from said first outer diameter portion to said second, reduced outer diameter portion at its distal end.

7. A dilatation balloon device comprising;

an inflatable balloon,

a flexible elongated, torque transmitting hollow metal main tubular body extending from a proximal region of the device to a position spaced substantially from a distal end of the device, said inflatable balloon disposed adjacent the distal end of said main tubular member and in fluid flow connection therewith, said main tubular body defining an interior volume adapted to conduit inflation liquid for said balloon,

flexible spanning structure extending distally from an end of said main tubular body, said spanning structure defining a fluid passage for communication between a distal portion of said main tubular body and the balloon, and including a torque-transmitting element that extends from the main tubular body to a distal end of the balloon,

said torque transmitting element comprising a solid cross-section core wire joined to a distal end of said main tubular body and extending through said balloon, said main tubular member having a first outer diameter portion for most of its length and a second, reduced outer diameter portion at its distal end, an inner diameter of the second, reduced outer diameter portion corresponding to the outer diameter of the wire over a joint region at which said member and wire are joined, said tubular member having a fluid opening proximal of said joint region and said wire having a proximal portion spanning across said opening and extending proximally thereof, adapted to transfer stress from distal of said main tubular member to a portion of said main tubular member proximal of said opening, there being a flow path for inflation fluid to said opening within said tubular main body in a space defined at its inner periphery by an external surface of a proximal portion of said core wire.