Surgical stent featuring radiopaque markers

• US 6,293,966 B1
• Filed: 04/20/1998
• Issued: 09/25/2001
• Est. Priority Date: 05/06/1997
• Status: Expired due to Term

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Incorporated (Cook Group Incorporated)
• Inventors: Frantzen, John J.
• Primary Examiner(s): Prebilic, Paul B.
• Application Number:
  US09/063,562
• Time in Patent Office: 1,254 Days
• Field of Search: 623/1, 623/12, 623/1.15, 623/1.34, 606/153, 606/191, 606/198
• US Class Current: 623/1.15
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• 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 2002/91508 the meander having a difference in amplitude along the band
• CPC Class Codes: A61F 2002/91525 within the whole structure different bands showing different meander characteristics, e.g. frequency or amplitude
• CPC Class Codes: A61F 2002/91541 Adjacent bands are arranged out of phase
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2002/91566 connected trough to trough
• CPC Class Codes: A61F 2002/91591 Locking connectors, e.g. using male-female connections
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers

Abstract

Radiopaque marker elements for attachment to ends of a radially expandable surgical stent are disclosed. Each radiopaque marker element is homogeneously formed from a radiopaque material and attached through an attachment means to ends of the stent. The radiopaque marker elements enhance the visibility of the stent when the stent is viewed with a medical imaging device, such as a fluoroscope. The marker elements extend beyond ends of the stent. The marker elements are attached to the stent before radial expansion and are configured to radially expand along with the stent during surgical implantation thereof within a body lumen, such as an artery. The radiopaque marker elements can either be attached to an unmodified radially expandable surgical stent or to a prepped stent which includes receivers at ends of the stent particularly configured to attach to the radiopaque marker elements. The radiopaque marker elements include tabs which match a contour of the receivers so that secure attachment of the radiopaque marker elements to the receivers at the ends of the stent is provided.

Claims

1. A radiopaque radially expandable stent for surgical implantation into a body lumen, such as an artery, said stent having a generally cylindrical contour both before and after expansion thereof, said stent further comprising in combination:

a stent frame having a first stent end and a second stent end opposite said first stent end;

at least two marker members each being homogeneous and having a preformed size and shape corresponding to an associated portion of the stent frame before being attached thereto, including a first marker member and a second marker member, each marker member formed from a material which is radiopaque having a radiopacity than the stent frame; and

said first marker member being attached directly to said stent frame at said first stent end and said second marker member attached directly to said stent frame at said second stent end, said first and second marker members extending at least partially beyond said first and second stent ends and being attached at least at two circumferentially spaced apart locations about respective ones of said first and second stent ends,

whereby the maximum extent of the stent frame can be viewed with a fluoroscope.

2. The stent of claim 1 wherein said attachments include braze points where said marker members are brazed to said ends to which said marker members are attached.

3. The stent of claim 1 wherein said at least two marker members are circumferential in form extending completely around said cylindrical contour of said stent frame, said marker members having a diameter similar to a diameter of said stent frame and being radially expandable.

4. The stent of claim 3 wherein said first marker member and said second marker member have a marker contour which matches an end contour of said first end and said second end of said stent frame, said marker members located adjacent said ends, said end contour including wave-like undulations including a series of crests and troughs, said marker members located adjacent to and following said crests and troughs of said end contour of said first end and said second end as said marker members extend circumferentially around said cylindrical contour of said stent frame.

19. The stent of claim 1, wherein said at least two marker members comprise a plurality of discrete first marker members each joined to said first stent end at a respective location about the circumference thereof, and a plurality of discrete second marker members each joined to said second stent end at a respective location about the circumference thereof.

20. The stent of claim 19, wherein each of said discrete first and second marker members is shaped convex in a direction facing away from a respective said stent end.

5. A radiopaque marker member for a generally cylindrical, radially expandable surgical stent frame configured to be implanted into a body lumen, the stent frame having a central axis, a radius, a first generally circular end and a second generally circular end opposite the first generally circular end, said radiopaque marker comprising in combination:

at least one marker member being homogeneous and having a preformed size and shape corresponding to an associated portion of the stent frame before being attached thereto, said circumferential marker member formed of a marker material which has a greater radiopacity than a stent material forming other portions of the stent frame;

said circumferential marker member being generally circular and having a substantially constant radius from an axial center of said circumferential marker element and being substantially equal to the radius of the stent frame; and

means to attach said circumferential marker member to one of the ends of the stent frame such that said axial center located upon the central axis of the stent frame,

whereby the maximum extent of the stent frame can be viewed with a fluoroscope.

6. The radiopaque marker member of claim 5 wherein said circumferential marker member extends in a continuous fashion entirely around said axial center.

7. The radiopaque marker member of claim 5 wherein a first circumferential marker member is adapted to be attached through said attachment means to the first generally circular end of the stent frame and a second circumferential marker member similar to said first circumferential marker member is adapted to be attached through said attachment means to the second generally circular end of the stent frame.

8. The radiopaque marker member of claim 5 wherein said constant radius of said circumferential marker member is radially expandable from a lesser amount to a greater amount when the surgical stent frame is similarly radially expanded from a lesser radius to a greater radius.

9. The radiopaque marker member of claim 8 wherein said radial expansion means of said circumferential marker member includes said circumferential marker member is formed in an undulating pattern with a series of troughs and crests therein, said material forming said circumferential marker member having sufficient flexibility to allow a distance between adjacent said crests and adjacent said troughs in said circumferential marker member to be extended away from each other, increasing a circumferential length of said circumferential marker member and increasing said constant radius of said circumferential marker member.

10. The radiopaque marker member of claim 8, wherein radial expansion of said circumferential marker member is matched with radial expansion of the surgical stent frame to which said circumferential marker member is attached through said attachment means.

11. The radiopaque marker element member of claim 5 wherein said circumferential marker member extends beyond the end of the stent frame to which said circumferential marker member is attached.

12. A radially expandable surgical stent featuring separate radiopaque marker members joined thereto, said stent further comprising in combination:

a stent frame having a first end and a second end opposite said first end and connected to said first end by a plurality of stent elements arranged in a generally cylindrical form together forming said stent frame, said stent elements being radially expandable from a first diameter to a second diameter;

at least one marker member being homogeneous and having a preformed size and shape corresponding to an associated portion of the stent frame before being attached thereto, said marker member formed from a material which is radiopaque; and

a means joining said marker member directly to said stent frame at one of said ends of said stent such that said marker member extends at least partially beyond said stent end and is joined at least at two circumferentially spaced apart locations about said stent end,

whereby the maximum extent of the stent frame at said stent end can be viewed with a fluoroscope.

13. The surgical stent of claim 12 wherein said joining means includes a receiver on one of said stent frame and said marker member and a tab on another of said stent frame said marker member, said receiver being complementary to said tab to lockably receive said tab there into.

14. The surgical stent of claim 13 wherein said tab includes a neck and a knob connected to said neck, said knob having a greater width than said neck, said receiver having a rounded space and a gap adjacent said rounded space, said rounded space having a width greater than a width of said gap, said knob of said tab having a greater width than said gap of said receiver, such that when said knob of said tab is located within said rounded space of said receiver, said tab cannot be removed from said receiver by passing said knob of said tab through said gap of said receiver.

15. The surgical stent of claim 13 wherein said tab and said receiver are at least partially melted together in a manner securing said marker member to said stent frame.

16. The surgical stent of claim 15 wherein said at least on marker member is joined through said joining means to said first end of said stent frame and a second marker member is attached through said joining means to said second end of said stent frame, said first end of said stent frame having at least one receiver extending therefrom, said second end of said stent frame having at least one receiver extending therefrom, said at least one marker member having at least one tab thereon, and said second marker member having at least one tab thereon, each said marker member having an undulating contour with crests and troughs opposite said crests, said tab extending from one of said crests.

17. The surgical stent of claim 12, wherein said plurality of stent elements include at least two circumferential elements extending entirely around said generally cylindrical form of said stent frame and defining said first end of said stent frame and said second end of said stent frame, said circumferential elements having end contours including a series of troughs and crests alternating as said circumferential elements extend around said cylindrical form of said stent frame, said at least one marker member being substantially cylindrical and having a marker contour essentially identical in shape to said end contour of said circumferential elements forming said first end of said stent frame.

18. The surgical stent of claim 12, wherein said marker member comprises a plurality of discrete members each joined to said stent end at a respective location about the circumference thereof.