Intracranial stent for insertion into the cerebral venous sinus system and methods of use
A stent for insertion into an intracranial blood vessel of the cerebral venous sinus system includes a proximal end, a distal end, a body between the proximal end and the distal end, the body comprising a plurality of wires in a closed pattern, wherein the stent is configured for insertion into an intracranial blood vessel of the cerebral venous sinus system. The stent is further capable of being repositioned, retrieved/re-sheathed, and removed for more precise delivery.
1. A method of treating pulsatile tinnitus (PT) in a subject which comprises:
providing a stent that is braided and self-expanding,
the stent having a proximal end, a distal end, and a tubular flexible body between the proximal end and the distal end, with the same diameter at the proximal and distal end, the tubular flexible body comprising a wire arrayed in a cellular pattern,
wherein the tubular flexible body has a higher degree of stiffness in a first section of the tubular flexible body than in a second section of the tubular flexible body,
wherein the tubular flexible body has different zones of outward force, a length of between about 40 mm and about 80 mm, is configured to expand to conform to an ovoid or triangular shape of vessel of a cerebral venous sinus system of the subject, to secure itself to surrounding walls of the vessels, to be retrievable or re-sheathable and to be implanted in a stenosis in a selected vessel of the vessels of the cerebral venous sinus system,
inserting a guide wire and a flexible delivery catheter through an incision in the femoral, basilic, or internal jugular vein, the stent being contained within a lumen of the delivery catheter;
guiding the stent through one or more of the vessels of the cerebral venous sinus system in a collapsed configuration on the guide wire to the stenosis; and
releasing the stent from the guide wire at the stenosis in the selected vessel to allow the stent to self-expand, to alleviate the stenosis by forcing a surrounding narrowed segment of the selected vessel to expand, and to secure itself to the surrounding narrowed segment of the selected vessel to and maintain the patency of the selected vessel to treat the PT.
2. The method of claim 1 wherein the stent is collapsible within the delivery catheter.
3. The method of claim 1 wherein the selected vessel is a member selected from the group consisting of the superior sagittal sinus, the transverse sinus, the sigmoid sinus and the straight sinus.
4. The method of claim 1 wherein the stent comprises cells having different sizes in different sections of the stent.
5. The method of claim 1 further comprising collapsing the stent within the delivery catheter and repositioning the stent within the selected vessel.
6. The method of claim 1 wherein the stent comprises a plurality of wires interbraided in a closed cell pattern.
7. The method of claim 1 wherein the stent is delivered over the guide wire having a tip at the distal end of the guide wire.
8. The method of claim 7 wherein the tip has a tapered end.
9. The method of claim 7 wherein the tip is between 10 and 25 mm in length.
10. The method of claim 1 wherein the stent comprises a web structure that allows the stent to self-expand and contract repeatedly until the stent reaches a correct location and can be deployed and secured.
11. The method of claim 1 wherein the cellular pattern is a closed cell pattern.
12. The method of claim 1 wherein the wire is in a braided configuration.
13. A method of alleviating a stenosis in a cerebral venous sinus of a patient, wherein the stenosis causes pulsatile tinnitus (PT), the method comprising
implanting a braided self-expanding stent in a vein of the cerebral venous sinus at a site of the stenosis,
the braided self-expanding stent having a proximal end, a distal end, the same diameter of between about 6 mm and about 10 mm at each of the proximal and distal ends, a length of between about 40 mm and about 80 mm and a tubular flexible body between the proximal end and the distal end,
the tubular flexible body comprising a plurality of wires arrayed in a closed cell pattern,
wherein the tubular flexible body has a higher degree of stiffness in a first section of the stent than in a second section of the stent and is arranged to expand with chronic outward force to secure itself to a surrounding narrowed segment of the cerebral venous sinus such that the tubular flexible body conforms to the anatomy of the cerebral venous sinus to alleviate the stenosis by forcing the narrowed segment of the cerebral venous sinus to expand, and to alleviate the PT.
14. The method of claim 13 wherein the tubular flexible body has a higher degree of stiffness in a first section of the tubular flexible body than in a second section of the tubular flexible body and expands with chronic outward force to conform to an ovoid or triangular shape of the cerebral venous sinus.
15. The method of claim 13 wherein the wires are laser cut.
16. The method of claim 13 wherein the length of the stent is between 75 mm and 80 mm.
17. The method of claim 13 wherein the stent is delivered over a guidewire having a tip at a distal end.
18. The method of claim 17 wherein the diameter of the tip gradually increases from one end to the other.
19. The method of claim 13 wherein the stent is re-sheathable.
20. The method of claim 13 wherein the braided self-expanding stent comprises different spacings between cells in different sections of the stent to conform the stent to the shape of the cerebral venous sinus.