Segmented stent for flexible stent delivery system

• US 6,187,034 B1
• Filed: 01/13/1999
• Issued: 02/13/2001
• Est. Priority Date: 01/13/1999
• Status: Expired due to Term

• Current Assignee: Endologix
• Original Assignee: Nellix, Inc.
• Inventors: Frantzen, John J.
• Primary Examiner(s): Willse, David H.
• Assistant Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US09/229,856
• Time in Patent Office: 762 Days
• Field of Search: 623/1.11, 623/1.15, 623/1.16, 623/1.21, 604/96
• US Class Current: 623/1.11
• 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 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• 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 2002/91533 characterised by the phase between adjacent bands
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2002/91566 connected trough to trough
• 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

Abstract

A segmented stent 10 is disclosed as part of a flexible stent delivery system. The segmented stent 10 includes multiple segments 80 axially spaced from each other with unspanned gaps 45 between the segments 80. When the segmented stent 10 is flexed in a manner causing a central axis A to bend, the segments 80 maintain their form without significant flexing and the unspanned gaps 45 between the segments 80 are altered to provide flexing between the segments 80. A flexible balloon 110 is beneficially provided for delivery of the segmented stent 10 which includes separate cylindrical sections 120 which have an axial length which matches the axial length of each segment 80. Notches 130 are located between the cylindrical sections 120 in the flexible balloon 110 so that areas of flexing in the flexible balloon 110 line up with the unspanned gaps 45 in the segmented stent 10. Because the segments 80 are not attached together, the segmented stent 10 can be configured with a variety of different numbers and types of segments 80 having different sizes and different other properties in a custom manner as desired by the surgeon for maximum therapeutic effect of the segmented stent 10 once implanted into a body lumen L.

Claims

1. A flexible radially expandable stent for implantation into a body lumen, the stent comprising in combination:

at least three circumferential elements, each said circumferential element having a wave-like series of bends therein as each said circumferential element circumscribes a central axis of said stent, each said bend including a trough and a crest, said trough defining a portion of said circumferential element where said circumferential element is more distant from adjacent said circumferential elements than other portions of said circumferential element, said crest defining a portion of said circumferential element where said circumferential element is closer to adjacent circumferential elements than other portions of said circumferential element;

at least two gaps, each of said at least two gaps located between a different adjacent pair of said at least three circumferential elements;

at least one of said gaps being a spanned gap spanned by an axial element, said axial element having ends attached to said circumferential elements adjacent said spanned gap;

at least one of said gaps being an unspanned gap, such that said circumferential elements adjacent said unspanned gap are not connected together;

wherein an axial width of said unspanned gap remains substantially constant during and after implantation of said stent;

wherein said spanned gaps are axially narrower than said unspanned gaps before radial expansion of said stent;

wherein a pair of said circumferential elements located adjacent said spanned gap form one segment, said stent including at least two segments, said stent including an unspanned gap between said at least two segments; and

wherein said spanned gaps alternate with said unspanned gaps between pairs of adjacent said circumferential elements throughout said stent.

2. The stent of claim 1 wherein said spanned gaps are spanned by substantially inflexible axial elements, such that flexing of said stent occurs at said unspanned gaps rather than at said spanned gaps.

3. The stent of claim 2 wherein said axial elements of said spanned gaps attach to said circumferential elements adjacent said spanned gaps at troughs in said bends of said adjacent circumferential elements, such that no axial contraction of said segments occurs when said stent is radially expanded.

4. A stent delivery system for implantation within a body lumen of non-uniform diameter, the system comprising in combination:

a stent having at least two segments, each said segment including at least two circumferential elements located axially spaced from each other at axial ends of said segment;

each of said at least two circumferential elements having a wave-like series of bends therein as each said circumferential element circumscribes a central axis of said stent, each said bend including a trough and a crest, said trough defining a portion of said circumferential element where said circumferential element is more distant from adjacent said circumferential elements than other portions of said circumferential element, said crest defining a portion of said circumferential element where said circumferential element is closer to adjacent circumferential elements than other portions of said circumferential element;

said segments having different diameters of maximum radial expansion;

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 balloon having an inflated diameter at least as great as a diameter of maximum radial expansion of a larger of said segments adjacent said larger segment and an inflated diameter at least as great as a diameter of maximum radial expansion of a smaller of said segments adjacent said smaller segment; and

wherein said outer surface of said balloon has a substantially constant inflated radial size at locations on said outer surface of said balloon adjacent said at least two stent segments.

5. The system of claim 4 wherein said smaller segment of said stent is radially stronger than radial expansion forces of said balloon when said balloon is expanded, so that said balloon is restricted from full expansion adjacent said smaller segment of said stent when said balloon is inflated.

6. The system of claim 5 wherein said balloon includes at least two separate sections axially spaced from each other;

wherein said outer surface has 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

wherein said segments of said stent line up with said sections of said outer surface of said balloon.

7. The system of claim 6 wherein said stent includes at least one gap between said at least two segments, said gap spanned by an axial element having greater flexibility than a flexibility of axial elements spanning gaps between said at least two circumferential elements of each said segment.

8. The system of claim 6 wherein said stent includes at least one gap between said at least two segments, said at least one gap being an unspanned gap, such that said circumferential elements adjacent said unspanned gap are not connected together.

9. The system of claim 8 wherein each of said sections terminates axially at edges, said circumferential elements at said axial ends of at least one said stent segment adjacent one of said sections remaining at least partially inboard of said edges of said section.

10. The system of claim 9 wherein said at least two circumferential elements at said axial ends of said at least one stent segment each extend partially beyond said edges of said section adjacent said segment in which said at least two circumferential elements are located;

and

wherein said circumferential elements each extend radially inward toward said central axis on portions of said circumferential elements which extend beyond said edges and over said notches in said balloon.

11. 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.

12. The system of claim 11 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.

13. The system of claim 12 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.

14. The system of claim 13 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.

15. The system of claim 13 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.