Deformable scaffolding multicellular stent

• US 6,330,884 B1
• Filed: 06/02/1998
• Issued: 12/18/2001
• Est. Priority Date: 11/14/1997
• Status: Expired due to Term

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: TransVascular, Inc. (Medtronic Plc)
• Inventors: Kim, Steven W.
• Primary Examiner(s): Isabella, David J
• Application Number:
  US09/089,032
• Time in Patent Office: 1,295 Days
• Field of Search: 623/1.11, 623/1.12, 623/1.13, 623/1.23, 606/192, 606/194, 606/195, 606/198, 606/200, 606/191, 606/153, 606/154, 606/155, 606/156
• US Class Current: 128/898
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 17/0643 with separate closing member, e.g. for interlocking with staple
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12045 double occlusion, e.g. during anastomosis
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/3417 Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating syringe needles A61M5/32; dilators A61M29/00
• CPC Class Codes: A61B 18/00 Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body eye surgery A61F9/007; ear surgery A61F11/00
• CPC Class Codes: A61B 18/1477 Needle-like probes
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/00252 for by-pass connections, i.e. connections from heart chamber to blood vessel or from blood vessel to blood vessel
• CPC Class Codes: A61B 2017/00504 Tissue welding
• CPC Class Codes: A61B 2017/1107 for blood vessels
• CPC Class Codes: A61B 2017/1139 Side-to-side connections, e.g. shunt or X-connections
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61B 2017/12127 Double occlusion, e.g. for creating blood-free anastomosis site
• CPC Class Codes: A61B 2017/306 holding by means of suction
• CPC Class Codes: A61B 2017/347 : Locking means, e.g. for locking instrument in cannula
• CPC Class Codes: A61B 2018/00392 : Transmyocardial revascularisation
• CPC Class Codes: A61B 2018/1425 : Needle
• CPC Class Codes: A61B 90/40 : Apparatus fixed or close to patients specially adapted for providing an aseptic surgical environment
• CPC Class Codes: A61F 2/064 : with special features to facilitate anastomotic coupling anastomosis of natural blood vessels A61B17/11
• CPC Class Codes: A61F 2/07 : Stent-grafts
• CPC Class Codes: A61F 2/2493 : Transmyocardial revascularisation [TMR] devices
• CPC Class Codes: A61F 2/90 : characterised by a net-like or mesh-like structure
• 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 2/958 : Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/061 : provided with means for allowing access to secondary lumens
• CPC Class Codes: A61F 2002/30079 : magnetic
• CPC Class Codes: A61F 2002/825 : having longitudinal struts
• 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 2002/91533 : characterised by the phase between adjacent bands
• CPC Class Codes: A61F 2002/91558 : connected peak to peak
• CPC Class Codes: A61F 2002/91575 : connected peak to trough
• CPC Class Codes: A61F 2002/91591 : Locking connectors, e.g. using male-female connections
• CPC Class Codes: A61F 2210/009 : magnetic
• CPC Class Codes: A61F 2250/0048 : differing in mechanical expandability, e.g. in mechanical, self- or balloon expandability
• CPC Class Codes: A61M 2025/0076 : Unidirectional valves
• CPC Class Codes: A61M 2025/009 : the needle having a bent tip, i.e. the needle distal tip is angled in relation to the longitudinal axis of the catheter
• CPC Class Codes: A61M 2025/1052 : for temporarily occluding a vessel for isolating a sector

Abstract

A plastically deformable stent for implantation within a body passage includes a plurality of cylindrical segments, and a plurality of connectors extending between adjacent segments. Each segment has an alternating pattern of curvilinear elements extending about its circumference, including first and second sets of curvilinear elements having different resistances to expansion, and preferably defining “U” shapes with alternating lengths that are connected to one another to define a substantially sinusoidal pattern. The connectors define a sinusoidal shape adapted to extend and compress axially substantially evenly when the adjacent segments are subjected to bending. The stent may be delivered on a device including an elongate member with a nose cone, an expandable member, and a proximal shoulder thereon, and an outer sheath for slidably receiving the elongate member therein. The outer sheath and/or nose cone may have perfusion holes for allowing continued perfusion of fluid during stent delivery. The device may be used in a method for implanting a stent within a curved region of a body passage, particularly for creating and/or maintaining a channel connecting a vein to an adjacent artery, preferably in the coronary system.

Claims

1. A method of delivering an expandable stent across a channel connecting a vein to an adjacent artery, the method comprising the steps of:

providing a stent delivery device including an elongate member comprising a distal end, the elongate member comprising an expandable member and a nose cone on the distal end, and a stent in a contracted condition on the expandable member;

inserting the elongate member into an outer sheath to cover the stent, the outer sheath engaging the nose cone to provide a substantially smooth transition therebetween;

advancing the distal end of the elongate member along the vein until the nose cone is advanced into the channel;

positioning the stent across the channel;

withdrawing the outer sheath proximally to expose the stent within the channel;

expanding the stent to an enlarged condition within the channel with the expandable member; and

withdrawing the elongate member from the patient'"'"'s body.

2. The method of claim 1, wherein the elongate member includes a shoulder proximate the expandable member for preventing substantial proximal movement of the stent received thereon.

3. The method of claim 1, wherein the nose cone at least partially dilates the channel when the distal end of the catheter body is advanced therethrough.

4. The method of claim 1, wherein the outer sheath includes perfusion holes therethrough to allow continued flow of blood along the artery when the stent is positioned across the channel.

5. The method of claim 1, wherein the nose cone includes perfusion holes therethrough to allow continued flow of blood along the artery when the stent is positioned across the channel.

6. The method of claim 1, wherein the stent delivery device includes an externally observable marker, and wherein the marker is observed when the stent is positioned across the channel.

7. The method of claim 1, further comprising the step of dilating the channel with an expandable member on the outer sheath.

8. The method of claim 1, wherein the outer sheath includes an outer protrusion, and wherein the protrusion produces a tactile indication when the stent is positioned across the channel.

23. The method of claim 1, wherein the stent extends into at least one of the vein and the artery when the stent is expanded within the channel.

9. A method for delivering a stent across a channel between two adjacent blood vessels, the method comprising:

providing a delivery device comprising an elongate member including a nose cone on a distal end of the elongate member, a stent in a contracted condition on the distal end adjacent the nose cone, and a sheath covering the stent, the sheath engaging the nose cone to provide a substantially smooth transition therebetween;

advancing the distal end of the elongate member along the first blood vessel until the nose cone is advanced into the channel;

positioning the stent across the channel;

withdrawing the sheath to expand the stent to an enlarged condition to engage tissue surrounding the channel; and

withdrawing the elongate member from the patient'"'"'s body.

10. The method of claim 9, wherein the nose cone at least partially dilates the channel when the nose cone is advanced through the channel.

11. The method of claim 10, further comprising withdrawing and advancing the nose into the channel multiple times to dilate the channel.

12. The method of claim 9, wherein the elongate member comprises an expandable member on the distal end, the stent being provided on the expandable member, and wherein the step of withdrawing the sheath to expand the stent comprises:

withdrawing the sheath to expose the stent within the channel; and

expanding the expandable member to forcibly expand the stent to the enlarged condition to substantially engage tissue surrounding the channel.

13. The method of claim 9, wherein the stent is at least partially self-expanding, and wherein the step of withdrawing the sheath to expand the stent comprises withdrawing the sheath to expose the stent, whereupon at least a portion of the stent expands automatically to the enlarged condition.

14. The method of claim 9, further comprising creating the channel between the first and second blood vessels.

15. The method of claim 14, wherein the step of creating the channel comprises advancing a guidewire through the tissue between the first and second blood vessels.

16. The method of claim 15, wherein the step of advancing the elongate member comprises advancing the elongate member over the guidewire, thereby advancing the nose cone over the guidewire into the channel.

17. The method of claim 9, wherein the step of advancing the distal end of the elongate member comprises advancing the nose cone through the channel into the second blood vessel, and wherein at least one of the nose cone and the sheath includes perfusion holes therethrough to allow continued flow of blood along the second blood vessel.

18. The method of claim 9, wherein the delivery device includes an externally observable marker, and wherein the marker is observed when the stent is positioned across the channel.

19. The method of claim 9, further comprising the step of dilating the channel with an expandable member on the sheath.

20. The method of claim 9, wherein the sheath includes an outer protrusion, and wherein the protrusion produces a tactile indication when the stent is positioned across the channel.

21. The method of claim 9, wherein the advancing step comprises advancing the distal end of the elongate member percutaneously into a patient'"'"'s vasculature until the distal end is disposed within the first blood vessel.

22. A method for delivering a stent across a channel between two adjacent blood vessels of a patient, the method comprising:

providing a delivery device comprising an elongate member including a nose cone and an expandable member on a distal end of the elongate member, a stent in a contracted condition on the expandable member on the distal end adjacent the nose cone, and a sheath covering the stent, the sheath engaging the nose cone to provide a substantially smooth transition therebetween;

creating a channel through tissue between first and second adjacent blood vessels;

advancing the distal end of the elongate member from a percutaneous entry site into the patient'"'"'s vasculature and through the first blood vessel until the nose cone is advanced into the channel;

positioning the stent across the channel such that the stent extends into at least one of the first and second blood vessels;

withdrawing the sheath to expose the stent within the channel;

expanding the expandable member to expand the stent to an enlarged condition to engage tissue surrounding the channel; and

withdrawing the elongate member from the patient'"'"'s body.