Not Applicable.
Not Applicable.
The present teachings relate to systems and methods for deploying stents in main and side branch vessels.
Current techniques for stenting bifurcation arterial disease (such as bifurcation coronary artery disease) are difficult. There are currently no commercially available stents designed for bifurcations. The most widely used techniques for treating bifurcation coronary artery disease are: (i) Culotte, (ii) crush/step crush/double-kissing crush techniques, (iii) T and protrusion, or (iv) T stenting. These techniques use currently available technology and are challenging, involving many steps to re-wire branch vessels (sometimes through stent struts), which leads to increased radiation and contrast exposure. In addition, T and protrusion, Culotte, and T stenting do not maintain wire access throughout the bifurcation strategy, leading to the possibility of occluding a vessel during the procedure without easy access. In addition to true bifurcation disease, isolated ostial arterial disease can also be challenging to treat with stents. In the setting of isolated ostial-proximal disease, attempts are made to precisely deploy an ostial stent without missing the ostium (deployment too distally) or hanging the stent into the main vessel (deployment too proximal). However, there is often geographic miss, due to “stent pistoning” during deployment and cardiac motion. The limitations in two dimensional fluoroscopic images also make landing an ostial stent precisely more challenging, requiring multiple views and contrast to precisely identify the origins of branches. A solution is needed to improve treatment of bifurcation disease, including isolated ostial disease, within coronary or peripheral arteries.
The present teachings include a system for deploying stents comprising at least one guidewire, a catheter with at least one guidewire port that can accommodate the at least one guidewire, at least one stent with at least one of a slanted edge and a non-slanted edge, and at least one balloon that expands to open the at least one stent. The stents may be advanced into their desired positions by both rapid exchange and over-the-wire techniques. With the former, the catheter only travels along approximately 25 cm of the guidewire before the guidewire is exposed, allowing for easier and quicker advancement and withdrawal of the catheter. With the latter, the guidewire tracks along the entire length of the catheter. The stents may have multiple slanted edges or no slanted edges. In an embodiment, the degree of the slant is between about 30 degrees and about 45 degrees. In another embodiment, the degree of the slant is between about 0 degrees and about 30 degrees. In yet another embodiment, the degree of the slant is between about 45 degrees and about 90 degrees. In yet another embodiment, the angle of the slant is between about 90 degrees and about 120 degrees. In yet another embodiment, the angle of the slant is between about 120 degrees and about 135 degrees. In yet another embodiment, the angle of the slant is between about 135 degrees and about 180 degrees. The guidewire port may accommodate guidewires of various diameters. In an embodiment, the diameter of the guidewire is between about 0.007 inches and about 0.038 inches. In another embodiment, the diameter of the guidewire is between about 0.013 inches and about 0.035 inches. In another embodiment, the diameter of the guidewire is between about 0.020 inches and about 0.030 inches. In addition, the stent may be made of a variety of materials, one of which is a metal (typically cobalt, titanium, or chromium) with a drug coating (drug eluting stents), such as sirolimus or everolimus to prevent tissue ingrowth and restenosis. In an embodiment, the stents are made of at least one of cobalt, titanium, and chromium with a sirolimus drug coating. In another embodiment, the stents are made of at least one of cobalt, titanium, and chromium with an everolimus drug coating. In yet another embodiment, the stents are made of at least one of cobalt, titanium, and chromium with no drug coating. In another embodiment, zotarolimus may be a drug coating for the stents. Zotarolimus, either by itself or in combination with other drug coatings, may be used to prevent smooth muscle proliferation. The diameter of the stent ranges from about 2 mm to about 40 mm. In another embodiment, the diameter of the stent ranges from about 5 mm to about 35 mm. In another embodiment, the diameter of the stent ranges from about 10 mm to about 30 mm. In another embodiment, the diameter of the stent ranges from about 15 mm to about 25 mm. The diameter of the balloon may range from about 2 mm to about 40 mm. In another embodiment, the diameter of the balloon ranges from about 5 mm to about 35 mm. In another embodiment, the diameter of the balloon ranges from about 10 mm to about 30 mm. In another embodiment, the diameter of the balloon ranges from about 15 mm to about 25 mm. The distance between the second guidewire port (proximal guidewire port) and the balloon/stent configuration ranges from about 0 mm to about 20 mm. In other embodiments, the distance between the guidewire port and the balloon/stent configuration ranges from about 2 mm to about 15 mm. In other embodiments, the distance between the guidewire port and the balloon/stent configuration ranges from about 4 mm to about 10 mm. The length of the guidewire lumen ranges from about 0.5 mm to about 400 cm. In other embodiments, the length of the guidewire lumen ranges from about 1 mm to about 200 cm. In other embodiments, the length of the guidewire lumen ranges from about 10 mm to about 100 cm. In other embodiments, the length of the guidewire lumen ranges from about 50 mm to about 50 cm. In other embodiments, the length of the guidewire lumen ranges from about 100 mm to about 10 cm. In other embodiments, the length of the guidewire lumen ranges from about 1 cm to about 5 cm.
In accordance with a further aspect, the system further comprises a radiopaque marker on the at least one stent. The radiopaque marker, especially in relation to the stents in side branch vessels, ensures inflation in the proper orientations of the slanted edge to cover the carina. Orientation can be adjusted by twisting the catheter.
In accordance with yet a further aspect, the at least one stent may be deployed in at least one of a kissing fashion and one at a time. The stents may be delivered at the same time, with one stent going to one side branch vessel, and another stent going to another side branch vessel. At their final destination, when they are expanded by their balloons, the stents are expanded such that their edges are touching (kissing) and extending into the main branch vessel.
In accordance with yet another aspect, the at least one slanted edge provides coverage of a bifurcation carina. By the edge of the stent in side branch vessels having a slanted edge, there can be complete coverage of the bifurcation carina overlapping with the stent in the main branch vessel. There is no need to crush a stent or re-wire through stent struts. In an embodiment, the stents in the side branch vessel may have more than more slanted edge. In another embodiment, the stents in the side bran vessel have only one slanted edge, which is the edge proximally located with the stent in the main branch vessel.
In accordance with yet another aspect, the at least one guidewire port allows delivery of the least one stent with a slanted edge. It is possible for a balloon/stent configuration to be guided to side branch vessels by way of the guidewire port. In an embodiment, the catheter has one guidewire port. In another embodiment, the catheter has more than one guidewire port. More guidewire ports allow for stent deployment in more than one side branch vessel. In another embodiment, multiple guidewire ports also allow for precise advancement of the balloon/stent into one side branch, but not past the ostium, as a second guidewire port will stabilize and anchor the balloon/stent in one side branch blood vessel relative to the second side branch blood vessel. In yet another embodiment, multiple guidewire ports allow a balloon/stent to be advanced over both guidewires to the bifurcation, but preventing the balloon/stent from being advanced into one of the side branch blood vessels. A stent meant for positioning within a side branch vessels move along a guidewire, while a stent for placement in the main branch vessels moves along more than one guidewire. For instance, if there are two guidewire ports, the stent for placement in the main branch vessels moves along two guidewires, and the two stents for placement in two separate side branch vessels move along two separate guidewires.
In accordance with yet another aspect, the at least one guidewire port allows delivery of the least one stent with a non-slanted edge. In an embodiment, a stent with a non-slanted edge may be placed in the side branch vessel, with the non-slanted edge distal from the main branch vessel. In another embodiment, a stent with a non-slanted edge is positioned in the main branch vessel, with the non-slanted edge either distal or proximal to a stent in a side branch vessel.
In accordance with yet another aspect, the slanted edge is at least one of less than 90 degrees and greater than 90 degrees in relation to a length of the at least one stent. The angle of the slant is less than 90 degrees or greater than 90 degrees depending on a side of the stent in which the angle is measured. The slanted edge aids in stent placement, particularly for stents positioned in side branch vessels.
In accordance with yet another aspect, the at least one balloon orients the slanted edges. Twisting the balloon prior to expansion may position stents with slanted edges so that they are deployed correctly. The addition of a second proximal guidewire port orients the slanted edge of the stent upon advancement. Proper orientation also provides maximum coverage of the carina.
In accordance with yet another aspect, the slanted edge is at at least one of a proximal edge of the at least one stent, a distal edge of the at least one stent, and a proximal edge and distal edge of the at least one stent.
In accordance with yet another aspect, the non-slanted edge is at at least one of a proximal edge of the at least one stent, a distal edge of the at least one stent, and a proximal edge and distal edge of the at least one stent. There are various configurations of the stent. The stent may have one slanted edge, or more than one slanted edge. The slanted edge may be the edge that is proximal to the entry point of the stent. The slanted edge may be the edge that is distal to the entry point of the stent. The slanted edge may be both proximal and distal to the entry point of the stent.
In accordance with yet another aspect, at least one balloon has at least one distal end that may accommodate at least one guidewire. The system is capable of accommodating more than one balloon, with each balloon possible of having more than one distal end. Having more than one distal end signifies that the balloon may employ more than one guidewire.
In accordance with yet another aspect, a distal end of the balloon may enter into a side branch vessel as a distal end of a stent abuts the bifurcation carina. In an embodiment, the distal end of the stent stops between about 0 mm and about 0.5 mm from the bifurcation carina. In an embodiment, the distal end of the stent stops between about 0.5 mm and about 1 mm from the bifurcation carina. In another embodiment, the distal end of the stent stops between about 1 mm about 1.5 mm from the bifurcation carina. In another embodiment, the distal end of the stent stops between about 1.5 mm and about 2 mm from the bifurcation carina. In yet other embodiment, the distal end of the stent stops right at the bifurcation carina.
The present teaching also include a method for deploying at least one stent, comprising: providing at least one guidewire, a catheter with at least one guidewire port that can accommodate the at least one guidewire, at least one stent with at least one of a slanted edge and a non-slanted edge, and at least one balloon that expands to open the at least one stent; threading the at least one guidewire through the catheter; moving the at least one balloon encircled by the at least one stent along the catheter to position the at least one stent; and opening the at least one stent by expanding the at least one balloon. Moving a stent to be positioned in a side branch vessel, the stent is guided along a guidewire to the desired position within the side branch vessel. It is possible to guide more than one stent into side branch vessels depending on the number of guidewires. Two stents may be guided into two separate side branch vessels with two guidewires, a guidewire for each stent. In addition, these stents may be deployed one at a time or simultaneously. A stent to be positioned in a main branch vessel moves along the guidewires that were used to position the stents in the side branch vessel. If there are two stents in the side branch vessels (one stent per side branch vessel), the main branch stent moves along two guidewires. Stents with slanted edges are typically placed in the side branch vessels, while those with non-slanted edges remain in the main branch, although it certainly is possible to place slanted edge stents in the main branch and non-slanted edge stents in the side branches.
In accordance with a further aspect, the at least one stent with the slanted edge is positioned in a side blood vessel. Placing a slanted edge stent in a side branch vessel allows for maximal coverage of the carina without crushing of the stent.
In accordance with yet another aspect, the at least one stent with the non-slanted edge is positioned in a main blood vessel. A non-slanted stent in the main branch overlaps with slanted edge stents in side branch vessels. In an embodiment, the side branch stents may have non-slanted edges. In another embodiment, the main branch stents may have slanted edges.
In accordance with yet another aspect, there is overlap between the at least one stent with the slanted edge and the at least one stent with the non-slanted edge. A particular configuration may be side branch stents with slanted edges proximal to a main side stent with non-slanted edges. It is possible for the main branch stent to have a slanted edge, albeit an edge that is not proximal to the slanted edge side branch stents.
In accordance with yet another aspect, the at least one guidewire extends into the side branch blood vessel. Via a guidewire port, a guidewire may extend into as many side branch vessels as there are guidewire ports. For instance, if there are two guidewire ports, there may be a guidewire extending into each side branch vessel.
In accordance with yet another aspect, the slanted edge is at at least one of a proximal edge of the at least one stent, a distal edge of the at least one stent, and a proximal edge and distal edge of the at least one stent. As stents may have several configurations, it is possible to have stents with one slanted edge or more than one slanted edge. With respect to main branch stents and side branch stents, the side branch stents may have a slanted edge that is proximal to the main branch stent. In another embodiment, the side branch stents may also have slanted edge this distal to the main branch stent. In yet another embodiment, the side branch stents may have slanted edges that are proximal and distal to the main branch stent. The slanted edge may be proximal to the entry point of the stent. The slanted edge may be distal to the entry point of the stent. The slanted edge may be proximal and distal to the entry point of the stent (i.e. there are two edges, one is proximal and one is distal to the entry point of the stent).
In accordance with yet another aspect, the non-slanted edge is at at least one of a proximal edge of the at least one stent, a distal edge of the at least one stent, and a proximal edge and distal edge of the at least one stent. In an embodiment, the non-slanted edge may be proximal to the entry point of the stent. In another embodiment, the non-slanted edge may be distal to the entry point of the stent. In yet another embodiment, the non-slanted edge may be both proximal and distal to the entry point of the stent (one edge is proximal and one edge is distal).
In accordance with yet another aspect, the slanted edge is at least one of less than 90 degrees and greater than 90 degrees in relation to a length of the at least one stent. A stent with no slanted edge has an angle of 90 degrees. The slanted edge angles the edge at varying angles, with varying angles being used for specific anatomic variations. The manner in which the angle is determined is based on the interception point of a length and height of the stent or a length and a width of the stent. Whether a slanted edge angle is less than or greater than 90 degrees is dependent on the length of the stent at which the angle is measured.
In accordance with yet another aspect, the at least one balloon orients the slanted edge. Balloon movement, either prior to or during partial expansion, may orient the slanted edge of the stent. Additional guidewires may also assist with orientation of the slanted edges.
In accordance with yet another aspect, a radiopaque marker is on the at least one stent. The radiopaque markers may assist with stent placement. Radiopaque markers may also assist with orientation of the slanted edges.
In accordance with yet another aspect, the balloon used with the stent has at least one distal end, with the distal end capable of entering side branches.
In accordance with yet another aspect, the distal end of the balloon is capable of moving into a side branch vessel once the stent advances right up to the bifurcation carina. A stent may also be mounted on two balloons that are molded together, allowing for Y splitting on proximal ends and distal ends of the balloon. Y splitting may also be on solely the proximal ends of the balloon. Y splitting may also be on solely the distal ends of the balloon.
In accordance with yet another aspect, as the balloon expands the stent, the distal ends also extend any stents that are in the side branches. In an embodiment, the distal ends expand the side branches. In another embodiment, the distal ends expand the side branches and stents within the side branches.
These and other features, aspects and advantages of the present teachings will become better understood with reference to the following description, examples and appended claims.
Those of skill in the art will understand that the drawings, described below, are for illustrative purposes only. The drawings are not intended to limit the scope of the present teachings in any way.
The present invention is directed to a system 100 that deploys stents 120 more precisely by there being at least one guidewire port 110, as shown in
In
The detailed description set-forth above is provided to aid those skilled in the art in practicing the present invention. However, the invention described and claimed herein is not to be limited in scope by the specific embodiments herein disclosed because these embodiments are intended as illustration of several aspects of the invention. Any equivalent embodiments are intended to be within the scope of this invention. Indeed, various modifications of the invention in addition to those shown and described herein will become apparent to those skilled in the art from the foregoing description which do not depart from the spirit or scope of the present inventive discovery. Such modifications are also intended to fall within the scope of the appended claims.
This application claims the benefit of U.S. Provisional Application No. 63/159,375 filed on Mar. 10, 2021, and Provisional Application No. 63/252,587 filed on Oct. 5, 2021, which are incorporated herein by reference in their entirety.
Filing Document | Filing Date | Country | Kind |
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PCT/US2022/019820 | 3/10/2022 | WO |
Number | Date | Country | |
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63252587 | Oct 2021 | US | |
63159375 | Mar 2021 | US |