Stent delivery system

• US 6,712,827 B2
• Filed: 04/16/2002
• Issued: 03/30/2004
• Est. Priority Date: 08/23/1996
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Dusbabek, Andrew J., Larson, Christopher R., Ellis, Louis G., Brown, Terry V.
• Primary Examiner(s): Lucchesi, Nicholas D.
• Assistant Examiner(s): BAKER, LORI LYNN
• Application Number:
  US10/124,111
• Publication Number:
  US 20020123794A1
• Time in Patent Office: 714 Days
• Field of Search: 606/108, 606/195, 606/198, 604/96
• US Class Current: 606/108
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/9583 Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve
• CPC Class Codes: A61F 2002/9586 the means being inside the balloon
• CPC Class Codes: A61L 29/04 Macromolecular materials
• CPC Class Codes: A61M 2025/1013 with concentrically mounted balloons, e.g. being independently inflatable
• CPC Class Codes: A61M 2025/1063 having only one lumen used for guide wire and inflation, e.g. to minimise the diameter
• CPC Class Codes: A61M 2025/1079 having radio-opaque markers in the region of the balloon
• CPC Class Codes: A61M 2025/1093 having particular tip characteristics
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters
• CPC Class Codes: A61M 25/10184 Means for controlling or monitoring inflation or deflation
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A stent delivery system to facilitate introduction and placement of a stent, including a catheter having an expandable distal portion constructed and arranged for expanding the outer diameter of the catheter from a contracted state to an expanded state: a stent positioned around the distal portion of the catheter having a contracted condition and being expandable to an expanded condition, and being sized in the contracted condition to closely surround the catheter in the contracted state, the expandable distal portion of the catheter including a balloon within which there is included on the catheter shaft at least one body of a diameter larger than the catheter shaft to which the stent and balloon are fitted, as by crimping, for holding the stent in place until it is released therefrom by expansion of the balloon.

Claims

1. A balloon catheter for dilating vascular constrictions and for simultaneously introducing a deformable stent into a vessel to be dilated in order to stabilize the vessel in the dilated condition, wherein a distal region of the catheter, which is intended to receive the deformable stent, comprises:

an inner tube that is surrounded and crimped onto by the deformable stent;

a balloon arranged between the deformable stent and the inner tube;

a pair of longitudinally spaced image sensitive marking sleeves carried on the inner tube within the balloon such that there is a longitudinal space on the inner tube extending between the pair of marking sleeves and such that the deformable stent is substantially centered there-between;

an outer tube disposed between the inner tube and the balloon as an intermediate layer, wherein the intermediate layer substantially covers the longitudinal space on the inner tube between the image sensitive marking sleeves, the intermediate layer having an outer diameter, wherein the outer diameter of the intermediate layer is substantially constant between the pair of marking sleeves.

2. A balloon catheter as set forth in claim 1, wherein the inner tube, the balloon, the outer tube forming the intermediate layer and the deformable stent which is crimped onto said catheter form a pre-assembled unit.

3. A balloon catheter as set forth in claim 1, wherein the outer tube comprises an elastic material into which the deformable stent is pressed in the crimping operation.

4. A balloon catheter as set forth in claim 1, wherein the intermediate layer comprises high density polyethylene.

5. A balloon catheter as set forth in claim 1, wherein the intermediate layer includes at least one separation whereby the flexibility of the body and catheter is increased.

6. A balloon catheter as set forth in claim 1, wherein the separation is a spiral separation.

7. A balloon catheter as set forth in claim 5, wherein there are a plurality of separations.

8. A balloon catheter as set forth in claim 7, wherein the plurality of separations are substantially parallel.

9. A balloon catheter as set forth in claim 1, wherein the intermediate layer includes at least one cut in its surface.

10. A balloon catheter as set forth in claim 9, wherein the cut is a spiral separation.

11. A balloon catheter as set forth in claim 9, wherein there are a plurality of cuts.

12. A balloon catheter as set forth in claim 11, wherein the plurality of cuts are circumferential cuts and are substantially parallel.

13. A balloon catheter as set forth in claim 1, further including a stop carried by the inner tube inside the balloon.

14. A balloon catheter as set forth in claim 1, wherein the intermediate layer is generally cylindrical in shape.

15. A balloon catheter as set forth in claim 1, including a pair of stops, each of which is respectively positioned at opposite ends of the deformable stent and carried by the inner tube inside the balloon.

16. Balloon catheter for expansion of vessel stenoses and for simultaneous introduction of a deformable stent, the deformable stent being expandable from an unexpanded condition to an expanded condition, into the vessel which is to be expanded in order to stabilize it in the expanded condition, whereby the distal area of the catheter which is provided for receiving the deformable stent has an interior tube which is surrounded by the unexpanded deformable stent, a balloon is arranged between the deformable stent and the interior tube, and the interior tube has at its ends two sleeves applied to it as image sensitive markers which are composed of material opaque to X rays and are provided within the balloon on the interior tube, the catheter further comprising a intermediate tube which forms an additional plateau and which is composed of a flexible material is provided between interior tube and exterior balloon as an intermediate layer in such manner that it extends in longitudinal direction to the sleeves which form the image sensitive markers, the intermediate layer having an outer diameter, wherein the outer diameter of the intermediate layer is substantially constant between the pair of image sensitive markers.

17. A balloon catheter for introducing a stent, the stent being expandable, into a vessel comprising an inner tube that is surrounded and crimped onto by the stent;

a balloon arranged between the stent and the inner tube;

a first marking sleeve having a distal end and a proximal end and a second marking sleeve having a distal end, wherein the sleeves are longitudinally spaced from one another along the inner tube, the second marking sleeve being distal to the first marking sleeve along the inner tube, and are image sensitive, the sleeves being carried on the inner tube within the balloon, such that there is a longitudinal space on the inner tube extending between the pair of marking sleeves and such that the stent is substantially centered there-between, an intermediate layer disposed between the inner tube and the balloon, the intermediate layer having a proximal portion and a distal portion, wherein the proximal portion covers the inner tube and is positioned immediately distal to the distal end of the first marking sleeve and wherein the distal portion covers the inner tube and is positioned immediately proximal to the proximal end of the second marking sleeve.

18. The balloon catheter of claim 17, wherein the intermediate layer extends from the distal end of the first marking sleeve to the proximal end of the second marking sleeve.

19. The balloon catheter of claim 17, the first marking sleeve having an outer diameter and the intermediate layer having an inner diameter, wherein the inner diameter of the intermediate layer is equal to or less than the outer diameter of the first marking sleeve.

20. The balloon catheter of claim 18, the intermediate layer having an outer diameter, wherein the outer diameter of the intermediate layer is substantially constant between the pair of marking sleeves.