Ostial stenting under vision
A system comprising a stent and a stent delivery device configured with a tiny intravascular ultrasound (“IVUS”) transducer on the tip of a delivery catheter which can image the interior of blood vessels. Methods for treating ostial or bifurcated lesions using the system.
1 . An intravascular stenting system comprising:
a catheter having a fluid-filled lumen,
a guidewire,
at least one intravascular ultrasound (“IVUS”) transducer, and
a stent comprising a balloon-expandable segment on a balloon;
wherein the fluid-filled lumen is operatively connected to an inflation device at its proximal end and at its distal end to the balloon inside of the balloon-expandable segment of the stent;
wherein a distal segment of the catheter comprises a guidewire port through which the guidewire extends into a distal portion of the fluid-filled lumen, and
wherein the fluid-filled lumen comprises one or more fiber optic lines operably connected to the at least one IVUS transducer, and
wherein the catheter further comprises 1 mm scale markings on its external surface.
2 . The intravascular stenting system of claim 1 , wherein the stent further comprises a proximal self-expanding section, which may comprise a cover, and a distal section comprising the balloon-expandable segment on the balloon; and wherein the stent is configured to deploy by inflation of the balloon.
3 . The intravascular stenting system of claim 2 , wherein the balloon-expandable segment and self-expanding section of the stent have an undeployed diameter ranging from 1 to 6 mm and a deployed diameter ranging from 2 to 8 mm, and together have a length ranging from 5 to 60 mm.
4 . The intravascular stenting system of claim 2 , wherein the self-expanding section of the stent comprises nickel-titanium.
5 . The intravascular stenting system of claim 2 , wherein the cover for the self-expanding section of the stent is cleavable and comprises platinum or a platinum alloy.
6 . The intravascular stenting system of claim 2 , wherein the self-expanding section of the stent is configured to flare into a trumpet-shape that has a proximal trumpet bell portion having a larger diameter than the balloon-expandable segment.
7 . The intravascular stenting system of claim 1 , wherein the stent further comprises a drug coating comprising at least one selected from the group consisting of everolimus, zotarolimus, sirolimus and biolimus, or a drug that reduces in-stent restenosis.
8 . The intravascular stenting system of claim 1 , wherein the catheter or stent has at least one radiopaque marking.
9 . The intravascular stenting system of claim 1 , wherein the at least one IVUS transducer comprises a single rotating IVUS transducer.
10 . The intravascular stenting system of claim 1 , wherein the catheter comprises a fixed array of at least two IVUS transducers.
11 . The intravascular stenting system of claim 1 , wherein the balloon is longer than the stent and has ends that protrude beyond a length of the stent.
12 . The intravascular stenting system of claim 1 , wherein the one or more fiber optic lines are operably connected to an interface which processes data from the at least one IVUS transducer into an image and/or a monitor that displays the image.
13 . A method for treating an ostial or other bifurcated intravascular lesion, comprising:
inserting the intravascular stenting system of claim 1 into a vascular system of a patient,
observing or locating the lesion by IVUS,
stenting the lesion by inflating the balloon and when a self-expandable section and covering are present, to cleave the covering of the self-expanding section, and
removing the catheter.
14 . The method of claim 13 , further comprising assessing stent placement by IVUS after deployment of the stent.
15 . The method of claim 13 , further comprising implanting the stent in a daughter-vessel ostium followed by stenting of the parent-vessel across the daughter-vessel.
16 . The method of claim 13 , wherein the lesion is an aorto-ostial or more proximal lesion.
17 . The method of claim 13 , wherein the stent has a drug coating comprising at least one selected from the group consisting of everolimus, zotarolimus, sirolimus and biolimus, or a drug that reduces in-stent restenosis.
18 . An intravascular
stenting system comprising:
a catheter having a fluid-filled lumen,
a guidewire,
at least one intravascular ultrasound (“IVUS”) transducer, and
a stent comprising a balloon-expandable segment on a balloon;
wherein the fluid-filled lumen is operatively connected to an inflation device at its proximal end and at its distal end to the balloon inside of the stent;
wherein a distal segment of the catheter comprises a guidewire port through which the guidewire extends into a distal portion of the fluid-filled lumen,
wherein the fluid-filled lumen comprises one or more fiber optic lines operably connected to the at least one IVUS transducer, and
wherein the catheter has an outer diameter ranging from about 0.5 to 4.0 mm and an inner lumen diameter ranging from about 0.3 to 3.5 mm, wherein the one or more fiber optic lines range in diameter from 0.1 to 0.5 mm, and wherein the guidewire ranges in diameter from 0.2 to 0.5 mm.
19 . An intravascular stenting system comprising:
a catheter having a fluid-filled lumen,
a guidewire,
at least one intravascular ultrasound (“IVUS”) transducer, and
a stent comprising a balloon-expandable segment on a balloon;
wherein the fluid-filled lumen is operatively connected to an inflation device at its proximal end and at its distal end to the balloon inside of the stent;
wherein a distal segment of the catheter comprises a guidewire port through which the guidewire extends into a distal portion of the fluid-filled lumen, wherein the lumen comprises one or more fiber optic lines operably connected to the at least one IVUS transducer, and
wherein the stent has a first radiopaque marking about 0.5 to 1.5 mm distal to the at least one IVUS transducer, a second radiopaque marking at a proximal edge of the balloon, and a third radiopaque marking at a distal edge of the balloon; and when a proximal self-expanding section is present, a radiopaque marker on the catheter at a junction between the proximal self-expanding segment and the balloon-expandable segment.