Dilatation balloon within an elastic sleeve

• US 5,116,318 A
• Filed: 06/06/1989
• Issued: 05/26/1992
• Est. Priority Date: 06/06/1989
• Status: Expired due to Term

• Current Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Original Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Inventors: Hillstead, Richard A.
• Primary Examiner(s): Hafer, Robert A.
• Assistant Examiner(s): Owens, Kerry
• Application Number:
  US07/362,251
• Time in Patent Office: 1,085 Days
• Field of Search: 606/191, 606/192, 606/194, 606/195, 606/198, 606/200, 604/8, 604/96
• US Class Current: 604/103.14
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61M 2025/1081 having sheaths or the like for covering the balloon but not forming a permanent part of the balloon, e.g. retractable, dissolvable or tearable sheaths
• CPC Class Codes: A61M 25/104 used for angioplasty
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

The stent placement dilation balloon assembly comprises a catheter having a distal end, a distal end portion, and a proximal end, a balloon mounted to, about, and around the distal end portion of the catheter which has at least one opening therein communicating with the interior of the balloon, and, an elastic sleeve positioned about and around the balloon. The sleeve has an at rest diameter which is less than the width of the collapsed balloon if the collapsed balloon was allowed, when deflated, to assume a flat shape. A stent is mounted on the sleeve for placement in a vessel in a human body.

Claims

1. A dilatation balloon assembly for insertion into a blood vessel comprising:

a catheter having a distal end, distal end portion, a proximal end and an overall outer diameter;

a dilatation balloon mounted to, about, and around said distal end portion of said catheter and having an interior, an elongate axis, a deflated balloon outer diameter and an at rest collapsed state width;

said catheter having means in said distal end portion thereof for communicating with the interior of said balloon; and

, an elastic sleeve having a length sufficient to extend the length of said balloon only and not the length of said catheter, being positioned about and around said balloon, being arranged for substantially no axial movement relative to the elongate axis of said balloon so that said sleeve is generally longitudinally coextensive with said balloon at all times, and having an at rest diameter which is less than the width of the collapsed balloon if the collapsed balloon was allowed, when deflated, to assume a flat shape and less than the deflated balloon outer diameter such that said sleeve, when at rest, is in a compressive state compressing said balloon to a smaller diameter.

2. The balloon assembly of claim 1 wherein said elastic sleeve has an elongation index of approximately 900 percent.

3. The balloon assembly of claim 1 wherein said elastic sleeve has an index of elongation and an outer diameter relative to the outer diameter of the deflated balloon which will enable said sleeve to be 75 percent smaller, O.D. to O.D., than the deflated balloon.

4. The balloon assembly of claim 1 wherein said elastic sleeve is fixed to said catheter at its proximal end and at its distal end around and about said balloon.

5. The balloon assembly of claim 1 wherein said sleeve is collapsible around said balloon to a diameter equal to or less than the overall outer diameter of said catheter.

6. A stent placement balloon assembly for insertion into a blood vessel including:

a collapsible/expandable stent and a dilatation balloon assembly, said dilatation balloon assembly including;

a catheter having a distal end, a distal end portion, a proximal end, and an overall outer diameter;

a dilatation balloon mounted to, about and around said distal end portion of said catheter and having an interior, an elongate axis, a deflated balloon outer diameter and an at rest collapsed state width;

said catheter having means in said distal end portion thereof for communicating with the interior of said balloon; and

, an elastic sleeve having a length sufficient to extend the length of said balloon only and not the length of said catheter, being positioned about and around said balloon, being arranged for substantially no axial movement relative to the elongate axis of said balloon so that said sleeve is generally longitudinally co-extensive with said balloon at all times, and having an at rest diameter which is less than the width of the collapsed balloon if the collapsed balloon was allowed, when deflated, to assume a flat position and less than the deflated balloon outer diameter such that said sleeve, when at rest, is in a compressive state compressing said balloon to a smaller diameter, and said collapsible/expandable stent being received around said elastic sleeve.

7. The assembly of claim 6 wherein said elastic sleeve has an elongation index of approximately 900 percent.

8. The assembly of claim 6 wherein said elastic sleeve has an index of elongation and an outer diameter relative to the outer diameter of the deflated balloon which will enable said sleeves to be 75 percent smaller, O.D. to O.D., than the deflated balloon.

9. The assembly of claim 6 wherein said elastic sleeve is fixed to said catheter at its proximal end and at its distal end around and about balloon.

10. The assembly of claim 6 wherein said sleeve is collapsible around said balloon to a diameter equal to or less than the overall outer diameter of said catheter.

11. In a dilatation balloon catheter for insertion into a blood vessel, a flexible, elongated member, an inflatable dilatation balloon having a deflated balloon diameter, an elongate axis, and being carried on the elongated member to define an inflation chamber within said balloon, and an inflation conduit extending along said member and communicating with the inflation chamber, the improvement comprising, in combination:

said inflatable balloon being surrounded by an elastomeric sleeve having a length sufficient to extend the length of said balloon only and not the length of said catheter, being made of an elastic material proportioned to transversely limit the dimensions of said balloon in deflated condition to predetermined maximum width less than the deflated balloon diameter and being arranged for substantially no axial movement relative to the elongate axis of said balloon so that said sleeve is generally longitudinally co-extensive with said balloon at all times.

12. The balloon catheter of claim 11 in which said inflatable balloon is made of a flexible material of less elasticity than the material of said elastomeric sleeve.

13. The balloon catheter of claim 11 in which said elastomeric sleeve is attached adjacent its proximal and distal ends to said balloon catheter.

14. The balloon catheter of claim 13 in which said elastomeric sleeve has a central portion and the central portion of said elastomeric sleeve is free of attachment to said inflatable balloon.

15. The balloon catheter of claim 11 wherein said elastomeric sleeve has an outer surface and has an expansible stent about the outer surface of said elastomeric sleeve.

16. In a dilatation balloon catheter for insertion into a blood vessel comprising a flexible, elongated member, an inflatable dilatation balloon made of elastic material, having a deflated balloon diameter, an elongate axis, and being carried on the elongated member to define an inflation chamber within said balloon and having a lateral deflated dimension, and an inflation conduit extending along said member and communicating with the inflation chamber, the improvement comprising, in combination:

said inflatable balloon being surrounded by an elastomeric sleeve having a length sufficient to extend the length of said balloon only and not the length of said catheter, being made of elastic material and proportioned to transversely limit the lateral dimension of said balloon in deflated condition to a predetermined maximum width less than the deflated balloon diameter and being arranged for substantially no axial movement relative to the elongate axis of said balloon so that said sleeve is generally longitudinally co-extensive with said balloon at all times, said inflatable balloon being made of a flexible material of less elasticity than the material of said elastomeric sleeve, and said elastomeric sleeve being attached adjacent its proximal and distal ends to said balloon catheter.

17. The balloon catheter of claim 16 in which said elastomeric sleeve has a central portion and the central portion of said elastomeric sleeve is free of attachment to said inflatable balloon.

18. The balloon catheter of claim 16 wherein said elastomeric sleeve has an outer surface and has an expansible stent about the outer surface of said elastomeric sleeve.