Stent delivery system featuring a flexible balloon

• US 6,022,359 A
• Filed: 01/13/1999
• Issued: 02/08/2000
• Est. Priority Date: 01/13/1999
• Status: Expired due to Term

• Current Assignee: Endologix
• Original Assignee: John J. Frantzen
• Inventors: Frantzen, John J.
• Primary Examiner(s): Hirsch, Paul J.
• Application Number:
  US09/229,519
• Time in Patent Office: 391 Days
• Field of Search: 606/108, 604/101, 604/96
• US Class Current: 606/108
• CPC Class Codes: A61F 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/825 having longitudinal struts
• CPC Class Codes: A61F 2002/826 more than one stent being applied sequentially
• CPC Class Codes: A61F 2002/828 Means for connecting a plurality of stents allowing flexibility of the whole structure
• CPC Class Codes: A61F 2230/0017 Angular shapes
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0065 toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61M 2025/1072 having balloons with two or more compartments
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters

Abstract

A flexible balloon 10 is provided for use in delivering and radially expanding a surgical stent 110. The flexible balloon 10 includes an interior which can be inflated with a fluid to expand the balloon 10 from a collapsed to an inflated radial size. The balloon 10 is formed with an outer surface 22 having a contour which includes a series of substantial cylindrical sections 20 spaced apart by notches 30. The notches 30 have a lesser radial size than that exhibited by the cylindrical sections 20. The notches 30 thus assist the balloon 10 in flexing to allow the balloon 10 to be passed through body lumens L having tight bends therein. A stent 110 is additionally disclosed which includes multiple separate segments 180. The segments 180 are sized to match axial length of the cylindrical sections 20 and are provided with greater flexibility axially between segments 180 than within segments 180 of the stent 110. Thus, areas of flexibility within the stent 110 align with areas of flexibility in the balloon 10. The flexible balloon 10 can either have cylindrical sections 20 of similar size or be configured as a tapering balloon 50 with both large sections 60 and small sections 70.

Claims

1. A flexible radially expandable stent delivery tool for supporting and locating a collapsed stent within a body lumen and expanding the stent when desired, the delivery tool comprising in combination:

an inflatable balloon having an interior enclosed by an outer surface, said outer surface extending radially from a central axis when said balloon is inflated;

said outer surface having at least two separate sections axially spaced from each other;

said outer surface having at least one notch between said at least two sections, said notch defining a portion of said balloon having a radial size less than a radial size of said outer surface at said at least two sections when said balloon is inflated; and

said outer surface supporting a radially expandable stent adjacent thereto, such that when said balloon is inflated, said stent is radially expanded.

2. The delivery tool of claim 1 wherein a wall thickness of said balloon between said interior and said outer surface is substantially uniform.

3. The delivery tool of claim 2 wherein said inflatable balloon is formed from a substantially inelastic flexible material, said balloon including folds in said outer surface before said balloon is inflated to allow said balloon to inflate radially away from said central axis.

4. The delivery tool of claim 1 wherein said at least two separate sections have different radial sizes after inflation of said balloon.

5. The delivery tool of claim 1 wherein each of said at least two sections is bounded by two edges, at least one edge of each said section located adjacent said at least one notch.

6. The delivery tool of claim 5 wherein said edges define transitions in said outer surface with a slope of said outer surface greater relative to said central axis on a notch side of said edge than on a section side of said edge.

7. The delivery tool of claim 6 wherein said notch includes a crease, said crease defining an abrupt transition in slope of said outer surface relative to said central axis, said crease defining a location of least radial size of said outer surface.

8. The delivery tool of claim 7 wherein said outer surface of said at least two separate sections is substantially cylindrical between said edges of said sections.

9. The delivery tool of claim 8 wherein said outer surface includes a slight radial recess on at least one of said sections and between said edges, said recess having a radial distance from said central axis less than portions of said section between said recess and said edges.

10. The delivery tool of claim 5 wherein said radially expandable stent includes at least two separate segments, each said segment having two end circumferential elements at axial ends of each said segment, said end circumferential elements of each said segment sufficiently close together to be at least partially overlying a common one of said at least two sections in said outer surface of said balloon.

11. The delivery tool of claim 10 wherein at least one said stent segment is axially located entirely inboard of said edges of one of said at least two sections.

12. The delivery tool of claim 10 wherein at least one said stent segment extends axially partially beyond said edges of one of said at least two sections.

13. The delivery tool of claim 10 wherein said at least two stent segments are joined together by at least one flexible link spanning a gap between said at least two stent segments.

14. The delivery tool of claim 10 wherein said at least two stent segments are spaced from each other by an unspanned gap, such that said end circumferential elements adjacent said unspanned gap are not connected together.

15. A radially expandable flexible balloon for insertion into a body lumen, the balloon comprising in combination:

an interior surrounded by an outer surface, said outer surface extending radially from a central axis when said balloon is inflated by a fluid passed into said interior;

said outer surface having at least two separate sections axially spaced from each other;

said outer surface having at least one notch between said at least two sections, said notch defining a portion of said balloon having a radial size less than a radial size of said outer surface at each of said at least two sections when said balloon is inflated;

said at least two sections having a radial size different from each other when radially expanded; and

said at least two sections sharing said interior, such that said sections are inflated and deflated together;

wherein said outer surface supports a radially expandable stent adjacent thereto, such that when said balloon is inflated, said stent is radially expanded; and

wherein said stent includes at lest two separate segments, each said segment having a different radial size after radial expansion of said stent.

16. The balloon of claim 15 wherein said at least two sections have a common size before inflation and radial expansion of said balloon;

wherein said at least two segments of said stent have a common size before radial expansion; and

wherein one of said stent segments is located over a larger one of said at least two sections and the other of said stent segments is located over a smaller one of said at least two sections, said stent segment located over said smaller section expanded radially less than said stent segment located over said larger section when said balloon is inflated.

17. A flexible stent delivery system comprising in combination:

an inflatable balloon having an interior surrounded by an outer surface, said outer surface extending radially from a central axis when said balloon is inflated;

said outer surface having at least two separate sections axially spaced from each other;

said outer surface having at least one notch between said at least two sections, said notch defining a portion of said balloon having a radial size less than a radial size of said outer surface at said at least two sections when said balloon is inflated; and

a radially expandable stent having a first collapsed radial size matching a radial size of said outer surface at said sections before said balloon is inflated and a second expanded radial size matching a radial size of said outer surface of said sections after said balloon is inflated.

18. The system of claim 17 wherein said stent includes at least two separate segments, each said segment having two end circumferential elements at ends of each said segment, said end circumferential elements of each said segment sufficiently close together to be at least partially overlying a common one of said at least two sections in said outer surface of said balloon;

and

wherein said end circumferential elements of each of said at least two segments are coupled together by at least one axial element spanning a gap between said end circumferential elements.

19. The system of claim 18 wherein said stent exhibits greater axial flex where said stent overlies said at least one notch in said outer surface of said balloon than an axial flexibility exhibited by said stent adjacent said at least two sections in said outer surface of said balloon.

20. The system of claim 19 wherein said at least one axial element joining said end circumferential elements is free of bends and gaps between adjacent said at least two stent segments and overlying said at least one notch in said outer surface of said balloon is spanned by an axial element including at least one bend therein, such that said bend allows said axial element spanning said gap between said stent segments to exhibit some axial adjustment in length to facilitate axial flexing of said at least two stent segments relative to each other.

21. The system of claim 19 wherein gaps between said at least two stent segments and overlying said at least one notch in said outer surface of said balloon are unspanned, such that said end circumferential elements adjacent said unspanned gap are not connected together.