Search Images Maps Play YouTube News Gmail Drive More »
Sign in
Screen reader users: click this link for accessible mode. Accessible mode has the same essential features but works better with your reader.

Patents

  1. Advanced Patent Search
Publication numberUS20060085061 A1
Publication typeApplication
Application numberUS 11/267,437
Publication dateApr 20, 2006
Filing dateNov 4, 2005
Priority dateNov 4, 1996
Also published asDE69736676D1, DE69736676T2, EP0944366A1, EP0944366A4, EP0944366B1, EP1723931A2, EP1723931A3, EP1723931B1, US6210429, US6962602, US20010037137, US20020116047, US20020156516, US20090132028, WO1998019628A1, WO1999036002A1
Publication number11267437, 267437, US 2006/0085061 A1, US 2006/085061 A1, US 20060085061 A1, US 20060085061A1, US 2006085061 A1, US 2006085061A1, US-A1-20060085061, US-A1-2006085061, US2006/0085061A1, US2006/085061A1, US20060085061 A1, US20060085061A1, US2006085061 A1, US2006085061A1
InventorsGil Vardi, Charles Davidson
Original AssigneeVardi Gil M, Davidson Charles J
Export CitationBiBTeX, EndNote, RefMan
External Links: USPTO, USPTO Assignment, Espacenet
Extendible stent apparatus and method for deploying the same
US 20060085061 A1
Abstract
An imageable extendable stent apparatus for insertion into a bifurcating vessel or a vessel opening. The stent apparatus comprises a main stent and a flared stent, which may used individually or in combination with each other. The flared stent may be interlocked with the main stent to provide stent coverage over the entire region of a bifurcation. The main stent of the apparatus may be deployed at the bifurcation point of a vessel, allowing unimpeded future access to the side branch of the bifurcated vessel. The flared stent may be employed at vessel openings. Also disclosed and claimed are methods for implanting the extendable stent apparatus into the bifurcation point or the ostium of a subject vessel.
Images(6)
Previous page
Next page
Claims(22)
1. An extending double-stent apparatus for placement in a bifurcating vessel comprising a first generally cylindrical stent having sides extending between first and second opposing ends and at least one opening being defined in a side; and a second generally cylindrical stent adapted to extend through one of said side openings of said first stent, said first and second stents each being constructed from a material which allows said stents to be expanded to conform to the shape of the subject vessel.
2. The stent apparatus of claim 1 wherein said second cylindrical stent additionally comprises a proximal end and an opposing distal end, wherein the proximal end additionally comprises a flared portion, which flared portion is in contact with the edges of said first stent side opening.
3. The stent apparatus of claim 1 wherein the stent apparatus is comprised of a biologically acceptable material.
4. The stent apparatus of claim 1 wherein the stents comprise a self-expanding material.
5. The stent apparatus of claim 1 wherein the stents comprise a balloon-expandable material.
6. The stent apparatus of claim 1 wherein at least a portion of the stents are imageable during and after insertion.
7. A generally cylindrical stent apparatus comprising a proximal end and a distal end, wherein the proximal end further comprises a flared portion for anchoring said stent apparatus into place within a vessel.
8. The stent apparatus of claim 7 wherein the flared portion is expandable from a compressed position to a configuration extending radially, at least in part, to the longitudinal axis of the stent apparatus.
9. The stent apparatus of claim 7 wherein the stent apparatus is comprised of a biologically acceptable material.
10. The stent apparatus of claim 7 wherein the stent comprises a self-expanding material.
11. The stent apparatus of claim 7 wherein the stents comprise a balloon-expandable material.
12. The stent apparatus of claim 7 wherein at least a portion of the stent is imageable during and after insertion.
13. A generally cylindrical stent apparatus having sides extending between first and second opposing ends and at least one opening being defined in a stent side.
14. The stent apparatus of claim 13 wherein the stent apparatus is comprised of a biologically acceptable material.
15. The stent apparatus of claim 13 wherein the stent comprises a self-expanding material.
16. The stent apparatus of claim 13 wherein at least a portion of the stents are imageable during and after insertion.
17. A method for deploying a stent apparatus into a bifurcated vessel comprising the steps of
routing a first guidewire into the main vessel of a subject bifurcating vessel and extending the guidewire beyond the bifurcation point;
inserting a first generally cylindrical stent apparatus comprising at least one side opening into an area of bifurcation of the main vessel;
aligning a side opening of the first stent apparatus with the bifurcation point of the bifurcated vessel by inserting a second guidewire and a stabilizing catheter into the first stent apparatus and into a subject branch vessel by passing the second guidewire and the stabilizing catheter through a side opening of the first stent apparatus and into the subject branch vessel; and
expanding the first cylindrical stent apparatus into contact with the walls of the main vessel.
18. The method of claim 17 further comprising
inserting along the second guidewire and into the stabilizing catheter of the branch vessel a second generally cylindrical stent apparatus, comprising a distal end and an opposed proximal end and further comprising a flared portion at the proximal end, positioned so that the flared portion is within a lumen of a subject branch vessel and contacts at least part of the edge of a side opening of the first stent apparatus;
withdrawing the stabilizing catheter from the subject vessel; and
expanding the second cylindrical stent apparatus at least into contact with the walls of the subject branch vessel.
19. The method of claim 17 wherein the step of expanding the first cylindrical stent apparatus is performed by balloon catheterization.
20. The method of claim 18 wherein the steps of expanding the first and second cylindrical stent apparatuses is performed by balloon catheterization.
21. A method for deploying a flared stent apparatus into the ostium of a vessel comprising:
inserting a guidewire through the ostium of a vessel and into the vessel,
inserting around the guidewire a generally cylindrical flared stent apparatus, the flared stent apparatus comprising a distal end and an opposed proximal end and further comprising a flared portion at the proximal end;
positioning the flared portion so that the flared portion is within the ostium of the vessel and contacts at least part of the ostium of said vessel;
dilating the flared stent apparatus at least into contact with the walls of the subject vessel, and
removing the guidewire from the subject.
22. The method of claim 21 further comprising the step of dilating the flared stent apparatus by balloon catheterization.
Description
    BACKGROUND
  • [0001]
    A type of endoprosthesis device, commonly referred to as a stent, is placed or implanted within a vein, artery or other tubular body organ for treating occlusions, stenoses, or aneurysms of the vessel. These stent devices are implanted within tubular vessels to reinforce collapsing, partially occluded, weakened, or abnormally dilated segments of the vessel wall. Stents have been used to treat dissections in blood vessel walls caused by balloon angioplasty of the coronary arteries as well as peripheral arteries and to improve angioplasty results by preventing elastic recoil and remodeling of the vessel wall.
  • [0002]
    Stents also have been successfully implanted in the urinary tract, the bile duct, the esophagus and the tracheo-bronchial tree to reinforce those body organs. Two randomized multicenter trials have recently shown a lower restenosis rate in stent treated coronary arteries compared with balloon angioplasty alone (Serruys P W et. al. New England Journal of Medicine 331: 489-495, 1994, Fischman D L et. al. New England Journal of Medicine 331: 496-501, 1994).
  • [0003]
    One of the drawbacks of conventional stents is that they are produced in a straight tubular configuration. The use of such stents to treat disease at or near a branch or bifurcation of a vessel runs the risk of compromising the degree of patency of the primary vessel and/or its branches or bifurcation and also limits the ability to insert a second stent into the side branch if the angioplasty result is suboptimal. This may occur as a result of several mechanisms such as displacing diseased tissue or plaque shifting, vessel spasm, dissection with or without intimal flaps, thrombosis, and embolism.
  • [0004]
    The risk of branch compromise is increased in two anatomical situations. First the side branch can be compromised when there is a stenosis in the origin of the side branch. Second, when there is an eccentric lesion at the bifurcation site, asymmetric expansion can cause either plaque shifting or dissection at the side branch origin. There are reports of attempting to solve this problem by inserting a balloon into the side branch through the stent struts; however, this technique carries the risk of balloon entrapment and other major complications (Nakamura, S. et al., Catheterization and Cardiovascular Diagnosis 34: 353-361 (1995)). Moreover, adequate dilatation of the side branch is limited by elastic recoil of the origin of the side branch. In addition, the stent may pose a limitation to blood flow and may limit access to the side branch. The term “stent jail” is often used to describe this concept. In this regard, the tubular slotted hinged design of the Palmaz-Schatz intracoronary stent, in particular, is felt to be unfavorable for lesions with a large side branch and it is believed to pose a higher risk of side branch vessel entrapment where the stent prevents or limits access to the side branch. Id.
  • [0005]
    One common procedure for implanting the endoprosthesis or stent is to first open the region of the vessel with a balloon catheter and then place the stent in a position that bridges the treated portion of the vessel in order to prevent elastic recoil and restenosis of that segment. The angioplasty of the bifurcation lesion has traditionally been performed using the kissing balloon technique where two guidewires and two balloons are inserted, one into the main branch and the other into the side branch. Stent placement in this situation will require the removal of the guidewire from the side branch and reinsertion of the guidewire via the stent struts and insertion of a balloon through the struts of the stent. The removal of the guidewire poses the risk of occlusion of the side branch during the deployment of the stent in the main branch.
  • [0006]
    Prior art patents refer to the construction and design of both the stent as well as the apparatus for positioning the stent within the vessel. One representative patent to Chaudhury, U.S. Pat. No. 4,140,126, discloses a technique for positioning an elongated cylindrical stent at a region of an aneurysm to avoid catastrophic failure of the blood vessel wall. The '126 patent discloses a cylinder that expands to its implanted configuration after insertion with the aid of a catheter. Dotter, U.S. Pat. No. 4,503,569, discloses a spring stent which expands to an implanted configuration with a change in temperature. The spring stent is implanted in a coiled orientation and is then heated to cause the spring to expand. Palmaz, U.S. Pat. No. 4,733,665, discloses a number of stent configurations for implantation with the aid of a catheter. The catheter includes a mechanism for mounting and retaining the vascular prosthesis or stent, preferably on an inflatable portion of the catheter. The stents are implanted while imaged on a monitor. Once the stent is properly positioned, the catheter is expanded and the stent separated from the catheter body. The catheter can then be withdrawn from the subject, leaving the stent in place within the blood vessel. Palmaz, U.S. Pat. No. 4,739,762, discloses an expandable intraluminal graft. Schjeldahl et. al., U.S. Pat. No. 4,413,989, discloses a variety of balloon catheter constructions. Maginot, U.S. Pat. No. 5,456,712 and Maginot, U.S. Pat. No. 5,304,220 disclose graft and stent assembly and method of implantation where a stent is used to reinforce a graft surgically inserted into a blood vessel in order to bypass an occlusion. However, none of these patents relate to the treatment of bifurcation lesions, or disclose a bifurcating stent apparatus and method for deploying the same.
  • [0007]
    Taheri, U.S. Pat. No. 4,872,874, Piplani et. al., U.S. Pat. No. 5,489,295, and Marin et al., U.S. Pat. No. 5,507,769, disclose bifurcating graft material which may be implanted with stents. However, there is no mention of bifurcation of the stent, and the stent is used only to anchor the graft into the vessel wall. It does not reinforce the vessel wall, nor does it prevent restenosis after angioplasty.
  • [0008]
    MacGregor, U.S. Pat. No. 4,994,071, discloses a hinged bifurcating stent. In the 071' patent, in contrast to the present invention, there is a main stent with two additional stents attached at one end, creating a single unit with a bifurcation. The two additional stents are permanently attached and cannot be removed from the main stent. Thus, this invention may not be used in non-bifurcation vessels. In addition, studies with hinge-containing stents have shown that there is a high incidence of restenosis (tissue growth) at the hinge point that may cause narrowing or total occlusion of the vessel and thus compromise blood flow. Furthermore, this design has a relatively large size which makes insertion into the vessel difficult. Also, by having the two additional stents connected to the main stent, tracking into a wide-angle side branch may be difficult and may carry the risk of dissection of the vessel wall. Furthermore, once the device of the '071 patent is implanted, it is impossible to exchange the side branch stent should the need for a different stent size arise.
  • [0009]
    In general, when treating a bifurcation lesion using commercially available stents, great care should be taken to cover the origin of the branch because if left uncovered, this area is prone to restenosis. In order to cover the branch origin, conventional stents must either protrude into the lumen of the main artery or vessel from the branch (which may causes thrombosis [clotting of blood], again compromising blood flow), or they must be placed entirely within the branch, and will generally not cover the origin of the bifurcation. Another frequent complication experienced with the stenting of bifurcations include narrowing or occlusion of the origin of a side branch spanned by a stent placed in the main branch. Lastly, placement of a stent into a main vessel where the stent partially or completely extends across the opening of a branch may make future access into such branch vessels difficult if not impossible.
  • [0010]
    In addition, conventional stent technology is inadequate as a means of treating ostial lesions. Ostial lesions are lesions at the origin of a vessel. For example, ostial lesions may form in renal arteries, which are side branches extending from the aorta. Ostial lesions are prone to restenosis due to elastic recoil of the main vessel, such as the aorta. Therefore, the stent cover must include the thickness of the wall of the main vessel. This is extremely difficult to accomplish without protrusion of the stent into the main vessel.
  • [0011]
    Lastly, conventional stents are difficult to visualize during and after deployment. While some prior art balloon catheters are “marked” at the proximal and distal ends of the balloon with imageable patches, no FDA-approved stents are currently available which are themselves imageable through currently known imaging procedures used when inserting the stents into a vessel.
  • [0012]
    Accordingly, there is a need for an improved stent apparatus and method for deploying the same which 1) may be used to effectively treat bifurcation lesions which reduces the risk of restenosis or occlusion of the side branch and which completely covers bifurcation lesions with the stent apparatus, 2) may be used to treat lesions in one branch of a bifurcation while preserving access to the other branch for future treatment, 3) may be used to treat ostial lesions, 4) allows for differential sizing of the stents in a bifurcated stent apparatus even after the main stent is implanted, and which 5) may be readily visualized by current or future visualization techniques.
  • SUMMARY OF THE INVENTION
  • [0013]
    The present invention concerns a novel extendable stent apparatuses and method for deploying the same. More particularly, the invention concerns a stent apparatus comprising an extendable stent which is suitable for treating bifurcation lesions, and which may also be used to treat lesions at the origin of a blood vessel or other organ. As used herein, the term “vessel” means any tubular tissue, and is not limited to vessels of the vascular system. Devices constructed in accordance with the invention include, singularly or in combination, a flared stent comprising a compressible flared portion at its proximal end, which flared portion may comprise hooks, compressible mesh or any other means of creating such a flared portion at the proximal end of the stent, and a main stent comprising at least one substantially circular opening located between its proximal and distal ends. For ease of visualization, both the flared stent and the main stent may be comprised of materials which are imageable, or the stents of the invention may be “marked” at the ends with an imageable substance and the main stent may also be marked at any opening. At least one flared stent may be extended through at least one opening of the main stent into at least one branch vessel for treating bifurcated or branched lesions, or the stents of the invention may be inserted individually for the treatment of ostial lesions, or lesions near bifurcations requiring a stent in either the main or the branch vessel with unobstructed access to the unstented vessel in the bifurcation. The methods of the invention comprises a two-step process used to deploy both the main and the flared stent in a bifurcated vessel, or to deploy the main stent only within a bifurcated vessel.
  • [0014]
    The stent apparatus of the invention may be constructed from any non-immunoreactive material that allows the apparatus to be expanded from an initial shape to a shape which conforms to the shape of the vessel or vessels into which the apparatus is inserted, including but not limited to any of the materials disclosed in the prior art stents, which are incorporated herein by reference. It is hypothesized that the stent apparatuses of the invention may further be constructed of a substance which is observable by imaging methods including but not limited to magnetic resonance, ultrasound, radio-opaque or contrast-dye, or may be marked at certain points including but not limited to the ends and around any opening or flared portion in a stent of the invention, with a material which is discernable by imaging methods as described above.
  • [0015]
    A stent constructed in accordance with the invention is suitable for implantation into any vessel in the body, including but not limited to vessels in the cardiac system, the peripheral vascular system, the carotid and intracranial vessels, the venous system, the renal system, the biliary system, the gastrointestinal system, the tracheobronchial system, the biliary system and the genitourinary system.
  • [0016]
    The stents of the invention are deployed utilizing a set of guidewires and catheters, which are then withdrawn from the subject following deployment of the stents. The stents of the invention may be self-expanding to conform to the shape of the subject vessel, or they may be expanded utilizing balloon catheters, or by any method currently known or developed in the future which is effective for expanding the stents of the invention. The flared stent of the invention is constructed such that the flared portion is confined along the wall of the flared stent by a sheath running parallel to the longitudinal axis of the flared stent until deployment, during which the sheath is removed and the flared portion is expanded into a configuration extending radially, at least in part, from the longitudinal axis of the flared stent.
  • [0017]
    Thus, it is an object of the present invention to provide a double-stent apparatus which makes it possible to completely cover the origin of a bifurcation lesion with a stent apparatus.
  • [0018]
    Another object of the invention is to provide a single-stent apparatus and method for deploying the same which may be used to treat only one branch of a bifurcation lesion but which will facilitate future treatment of the corresponding branch.
  • [0019]
    Yet another object of the invention is to provide a single-stent apparatus which is effective in treating ostial lesions.
  • [0020]
    A further object of the invention is to provide a method for insertion of the extendable double-stent apparatus into both the main and branch vessels of a bifurcation lesion.
  • [0021]
    Additionally, it is an object of the invention to provide a stent apparatus which is imageable during and after insertion.
  • [0022]
    These objects and other object advantages and features of the invention will become better understood from the detailed description of the invention and the accompanying drawings.
  • BRIEF DESCRIPTION OF THE DRAWINGS
  • [0023]
    FIG. 1 is a schematic depiction of the double-stent apparatus of the present invention in which both the main stent and the flared stent are fully dilated.
  • [0024]
    FIG. 2 is a schematic depiction of the main stent of the apparatus of the invention as deployed, without placement of the flared stent.
  • [0025]
    FIG. 3 is a schematic depiction of the flared stent of the apparatus as deployed, without the main stent.
  • [0026]
    FIG. 4 is a schematic depiction of the main stent of the apparatus deployed within a subject vessel.
  • [0027]
    FIG. 5 is a schematic depiction of the double-stent bifurcating stent apparatus, where the main stent is deployed and showing the placement of the flared stent apparatus prior to full deployment of the flared stent.
  • [0028]
    FIG. 6 is a schematic depiction of the method of the invention.
  • [0029]
    FIG. 6 a depicts initial placement of the main stent of the bifurcating stent apparatus into the vessel, along with the insertion of guidewire and stabilizing catheter for placement of the flared stent into the branch vessel of the subject.
  • [0030]
    FIG. 6 b is a schematic depiction of the step of inflating the main stent of the invention.
  • [0031]
    FIG. 6 c is a schematic depiction of the deployment of the flared stent over the side branch guidewire, through an opening in the main stent and into the branch vessel of the subject.
  • [0032]
    FIG. 6 d is a schematic depiction of the removal of the protective sheath of the flared stent, allowing for full expansion of the flared portion prior to placement and deployment.
  • [0033]
    FIG. 6 e is a schematic depiction of the fully extended flared stent positioned into the branch by the catheter, but prior to full deployment.
  • [0034]
    FIG. 6 f is a schematic depiction of the fully dilated main stent and the fully positioned flared stent, where the flared stent is being dilated by inflation of the balloon.
  • [0035]
    FIG. 6 g is a schematic depiction of the fully dilated bifurcating double stent of the invention, positioned into the bifurcation in a subject vessel.
  • [0036]
    The rectilinear matrices shown in the drawings are intended to show the shapes of the surfaces only, and do not illustrate the actual surface patterns or appearances of the stent apparatuses of the invention.
  • DESCRIPTION OF THE PREFERRED EMBODIMENTS
  • [0037]
    The bifurcating double-stent apparatus 10 of the present invention comprises a generally cylindrical main stent 12 and a generally cylindrical flared stent 15, which are shown as fully dilated in a subject main vessel 8 and a subject branch vessel 7, as illustrated in FIG. 1.
  • [0038]
    The main stent 12 contains at least one generally circular opening 16 located between the proximal end 26 and the distal end 28 of the main stent 12 (FIG. 2), which opening is positioned over the opening 48 of a branch vessel in a vessel bifurcation 50, as shown in FIG. 2. The ends of the stent 12 and the opening are imaged during imaging procedures by placing markers 56 around the edges of the opening 16 in the main stent 12 and at the proximal end 26 and distal end 28 of the main stent, as illustrated in FIG. 4.
  • [0039]
    The flared stent apparatus 15 of the present invention comprises a generally cylindrical flared stent comprising a proximal end 30 and a distal end 32, as shown in FIG. 3. The proximal end 30 comprises a flared portion, illustrated here as extended loops 18, which flared portion, when dilated, is positioned within the lumen 58 of the main vessel 8 (FIG. 3). The ends of the flared stent 15 and the flared portion 18 are imaged during imaging procedures by placing markers 56 around the flared portion 18 and at the proximal end 30 and distal end 32 of the flared stent, as illustrated in FIG. 5.
  • [0040]
    As shown in the embodiment of the invention illustrated in FIG. 4, a guidewire 20 is inserted into the vessel 8 prior to insertion of the main stent 12, and is used to guide the main stent 12 into position within the vessel 8. Prior to insertion and dilation, the main stent 12 is disposed around the distal end of a catheter 48 which may include an inflatable balloon 24. The main stent/catheter apparatus is then threaded onto the main guidewire 20 and into the vessel 8. The main stent 12 is dilated by inflation of the balloon 24 until it expands the walls of the vessel 8, and is thus affixed into place.
  • [0041]
    As shown in the embodiment of the invention illustrated in FIG. 5, prior to insertion of the flared stent 15, a guidewire 36 and a stabilizing catheter 44 are inserted through the opening 16 in the main stent 12, and into a branch vessel. The stabilizing catheter 44 is used to place the opening in the main stent 12 over the opening 16 in the bifurcation. The guidewire 36 is used to guide the flared stent 15 into position within a vessel. During insertion and prior to dilation, the flared stent 15 is disposed around the distal end of a branch catheter 54 which may include an inflatable balloon 25, and the flared portion 18 of the flared stent 15 is held in a compressed position by a protective sheath 34.
  • [0042]
    In the bifurcating double-stent apparatus 10 of the invention, once the main stent 12 is dilated and the stabilizing catheter 44 is removed, the flared stent 15 is inserted over the branch guidewire 36 and through the opening 16 of the main stent 12 substantially as shown in FIG. 5, and affixed in place by the expansion of the flared portion 18 positioned at the proximal end 30 of the flared stent, as shown in FIGS. 1 and 5. The angle at which the flared stent 15 is affixed depends upon the vessel structure into which the bifurcating stent apparatus 10 is inserted (FIG. 1).
  • [0043]
    The inventive two-stage method for implanting the novel bifurcating double-stent apparatus 10 begins with insertion of the main guidewire 20 into the subject main vessel 8 and across the bifurcation 50. Once the main guidewire 20 is in position in the main vessel 8, the main stent 12 is mounted around a catheter 48 (which may also comprise a balloon 24), and the catheter 48 and stent 12 are inserted into the main vessel 8. The stent 12 is positioned so that the opening 16 is directly over the bifurcation point 50 in the subject vessel (FIG. 6 a). In order to aid such positioning, a side branch guidewire 36 and a stabilizing catheter 44 (as depicted in FIGS. 5 and 6) are also inserted through the opening 16 of the main stent 12 and into the branch vessel 7 (FIG. 6 a).
  • [0044]
    In an alternative embodiment of the method of the invention, the main stent 12, the catheters 44 and 48 and the side branch guidewire 36 may be assembled in advance of insertion (with the stabilizing catheter 44 and the side branch guidewire positioned through the opening 16 of the main stent) into the subject, and then inserted into the bifurcation point 50 in the main vessel 8 simultaneously, after which the side branch guidewire 36 and the stabilizing catheter 44 are threaded into the branch vessel 7 in order to properly align the opening 16 in the main stent 12 (FIG. 6 a).
  • [0045]
    To affix the main stent 12 in the desired position within the vessel 8, the stent 12 may be dilated by inflating the balloon 24 until the main stent 12 is in contact with the walls of the vessel 8 (FIG. 6 b). Once the main stent 12 is dilated, the catheters 44 and 48 are withdrawn, leaving the fully positioned main stent 12 and the main guidewire 20 in the main subject vessel, and the side branch guidewire 36 in the subject branch vessel (FIG. 6 c).
  • [0046]
    In the second stage of the method of deploying the bifurcating double-stent of the invention, the flared stent catheter 54, containing the compressed flared stent 15 in a protective sheath 34 and which may further contain a balloon 25 disposed around the flared stent catheter 54 and inside the compressed flared stent 15, is inserted into the subject branch vessel 7 around the side branch guidewire 36 as shown in FIG. 6 c. The compressed flared stent 15 is initially positioned so that the compressed proximal end 30 of the flared stent extends into the lumen 42 of the main stent 12 to facilitate full expansion of the flared portion 18 after withdrawal of the protective sheath 34, prior to the final positioning of the flared stent 15 into the branch of the bifurcation (FIG. 6 c). The distal end 32 of the flared stent is initially positioned within the branch vessel 7 (FIG. 6 c). After the proximal end 30 of the compressed flared stent is properly placed within the lumen 42 of the main stent, the protective sheath 34 is withdrawn from the vessel 8, and the flared portion 18 of the flared stent 15 is decompressed to extend radially, at least in part, to the longitudinal axis of the flared stent 15, as shown in FIG. 6 d. After the flared portion 18 of the flared stent 15 is in its flared configuration (as shown in FIG. 6 d), the flared stent 15 is advanced into the side branch 7 at its proximal end 30 until at least a portion of flared portion 18 of the flared sheath 15 contacts at least a portion of an edge of the opening 16 of the main stent 12, as shown in FIG. 6 e. In this example, a balloon 25 is inflated in order to dilate the flared stent 15 to bring the walls of the flared stent 15 into contact with the walls of the branch vessel 7, as shown in FIG. 6 f. All remaining catheters and guidewires are then withdrawn from the subject, leaving the fully deployed bifurcating double-stent apparatus of the invention 10, comprising the main stent 12 with at least one opening 16, and the flared stent 15 positioned through the opening 16 into the branch vessel 7, as shown in FIG. 6 g.
  • [0047]
    When treating ostial lesions, the flared stent 15 alone is used, and is positioned utilizing catheters and guidewires as described above, except that a stabilizing catheter is not used, and the flared portion 18 of the flared stent is positioned at the ostium of a vessel, instead of into a side branch through the an opening 16 in a main branch. After the flared stent 15 is positioned near the ostium of a subject vessel, the protective sheath 34 is retracted in order to allow the flared portion to fully expanded and the flared stent 15 is further advanced with the proximal end of the catheter until the unfolded hooks 18 are in contact with the walls of the subject vessel.
  • [0048]
    All the stents of the invention may be deployed using the methods of the invention without resort to a balloon catheter. For example, a self-expanding compressed stent contained within a protective sheath could be self-dilated by retraction of a protective sheath. Other methods of dilation of the stents of the invention may exist, or may become available in the future, and such methods are contemplated as being within the scope of this invention. While this example used self-unfolding loops to demonstrate one means of creating a flared portion, any other means of creating a flare, such as but not limited to creating a roll in the stent material which is then compressed, is contemplated as within the scope of this invention.
  • [0049]
    It is the intent that the invention include all modifications and alterations from the disclosed embodiments that fall within the scope of the claims of the invention.
Patent Citations
Cited PatentFiling datePublication dateApplicantTitle
US4769005 *Aug 6, 1987Sep 6, 1988Robert GinsburgSelective catheter guide
US4774949 *Jun 14, 1983Oct 4, 1988Fogarty Thomas JDeflector guiding catheter
US4905667 *May 10, 1988Mar 6, 1990Ernst FoersterApparatus for endoscopic-transpapillary exploration of biliary tract
US5192307 *Feb 5, 1992Mar 9, 1993Wall W HenryAngioplasty stent
US5201757 *Apr 3, 1992Apr 13, 1993Schneider (Usa) Inc.Medial region deployment of radially self-expanding stents
US5304220 *May 3, 1993Apr 19, 1994Maginot Thomas JMethod and apparatus for implanting a graft prosthesis in the body of a patient
US5487730 *May 27, 1994Jan 30, 1996Medtronic, Inc.Balloon catheter with balloon surface retention means
US5609627 *Oct 4, 1994Mar 11, 1997Boston Scientific Technology, Inc.Method for delivering a bifurcated endoluminal prosthesis
US5636641 *Jul 25, 1994Jun 10, 1997Advanced Cardiovascular Systems, Inc.High strength member for intracorporeal use
US5676697 *Jul 29, 1996Oct 14, 1997Cardiovascular Dynamics, Inc.Two-piece, bifurcated intraluminal graft for repair of aneurysm
US5707348 *Jun 6, 1995Jan 13, 1998Krogh; Steve S.Intravenous bandage
US5749890 *Dec 3, 1996May 12, 1998Shaknovich; AlexanderMethod and system for stent placement in ostial lesions
US5755773 *Jun 4, 1996May 26, 1998Medtronic, Inc.Endoluminal prosthetic bifurcation shunt
US5893887 *Oct 14, 1997Apr 13, 1999Iowa-India Investments Company LimitedStent for positioning at junction of bifurcated blood vessel and method of making
US5972017 *Oct 28, 1997Oct 26, 1999Vascular Science Inc.Method of installing tubular medical graft connectors
US6093203 *May 13, 1998Jul 25, 2000Uflacker; RenanStent or graft support structure for treating bifurcated vessels having different diameter portions and methods of use and implantation
US6113579 *Mar 4, 1998Sep 5, 2000Scimed Life Systems, Inc.Catheter tip designs and methods for improved stent crossing
US6168621 *May 29, 1998Jan 2, 2001Scimed Life Systems, Inc.Balloon expandable stent with a self-expanding portion
US6203568 *Jul 24, 1998Mar 20, 2001Medtronic, Inc.Endoluminal prostheses having position indicating markers
US6210433 *Mar 17, 2000Apr 3, 2001LARRé JORGE CASADOStent for treatment of lesions of bifurcated vessels
US6254593 *Dec 10, 1999Jul 3, 2001Advanced Cardiovascular Systems, Inc.Bifurcated stent delivery system having retractable sheath
US6258115 *Apr 21, 1998Jul 10, 2001Artemis Medical, Inc.Bifurcated stent and distal protection system
US6261316 *Mar 11, 1999Jul 17, 2001Endologix, Inc.Single puncture bifurcation graft deployment system
US6264662 *Jul 21, 1998Jul 24, 2001Sulzer Vascutek Ltd.Insertion aid for a bifurcated prosthesis
US6264686 *Feb 24, 1998Jul 24, 2001RIEU RéGISIntravascular stent intended in particular for angioplasty
US6293968 *Oct 21, 1999Sep 25, 2001Syde A. TaheriInflatable intraluminal vascular stent
US6334864 *May 17, 2000Jan 1, 2002Aga Medical Corp.Alignment member for delivering a non-symmetric device with a predefined orientation
US6383213 *Mar 24, 2001May 7, 2002Advanced Cardiovascular Systems, Inc.Stent and catheter assembly and method for treating bifurcations
US6508836 *Jun 14, 2001Jan 21, 2003Advanced Cardiovascular Systems, Inc.Stent and catheter assembly and method for treating bifurcations
US6517558 *Feb 1, 2001Feb 11, 2003Ventrica, Inc.Methods and devices for forming vascular anastomoses
US6695877 *Feb 26, 2002Feb 24, 2004Scimed Life SystemsBifurcated stent
US6749628 *May 17, 2001Jun 15, 2004Advanced Cardiovascular Systems, Inc.Stent and catheter assembly and method for treating bifurcations
US6776793 *Jun 11, 2001Aug 17, 2004Scimed Life Systems, Inc.Longitudinally flexible expandable stent
US6858038 *Jun 21, 2002Feb 22, 2005Richard R. HeuserStent system
US6884258 *Feb 26, 2001Apr 26, 2005Advanced Stent Technologies, Inc.Bifurcation lesion stent delivery using multiple guidewires
US6896699 *Oct 8, 2003May 24, 2005Advanced Cardiovascular Systems, Inc.Stent and catheter assembly and method for treating bifurcations
US6932837 *Aug 27, 2002Aug 23, 2005Aga Medical CorporationRepositionable and recapturable vascular stent/graft
US7018400 *Feb 17, 2003Mar 28, 2006Medtronic Vascular, Inc.Endolumenal prothesis and method of use in bifurcation regions of body lumens
US7056323 *Jan 31, 2003Jun 6, 2006Scimed Life Systems, Inc.Stent security balloon/balloon catheter
US7060091 *Nov 7, 2003Jun 13, 2006Boston Scientific Scimed, Inc.Stent having variable properties and method of its use
US20010003161 *Dec 18, 2000Jun 7, 2001Vardi Gil M.Catheter with side sheath
US20010004706 *Feb 24, 1999Jun 21, 2001Hikmat HojeibaneBifurcated axially flexible stent
US20010004707 *Apr 25, 1997Jun 21, 2001Jean-Pierre Georges Emile DereumeIntraluminal endoprosthesis for ramifying the ducts of a human or animal body and method of manufacture thereof
US20010016766 *Dec 27, 2000Aug 23, 2001Vardi Gil M.Extendible stent apparatus
US20010025195 *Dec 1, 2000Sep 27, 2001Shaolian Samuel M.Flexible vascular graft
US20030004535 *Jul 31, 2002Jan 2, 2003Frank MusbachTextured and/or marked balloon for stent delivery
US20030009209 *Jun 26, 2002Jan 9, 2003Hikmat HojeibaneBifurcated axially flexible stent
US20030009214 *Aug 30, 2002Jan 9, 2003Shanley John F.Medical device with beneficial agent delivery mechanism
US20030014102 *Oct 12, 2001Jan 16, 2003James HongIntravascular Stent
US20030023301 *Sep 16, 2002Jan 30, 2003Cox Daniel L.Variable strength stent
US20030028233 *Dec 6, 1999Feb 6, 2003Vardi Gil M.Catheter with attached flexible side sheath
US20030050688 *Sep 13, 2001Mar 13, 2003Fischell David R.Stent with angulated struts
US20030055378 *Sep 14, 2001Mar 20, 2003Wang Yiqun BruceConformable balloons
US20030055483 *Aug 22, 2002Mar 20, 2003Gumm Darrell C.Rotating stent delivery system for side branch access and protection and method of using same
US20030074047 *Aug 27, 2002Apr 17, 2003Jacob RichterMethod of delivering a bifurcated stent
US20030093109 *Dec 16, 2002May 15, 2003Mauch Kevin M.Bifurcated catheter assembly
US20030097169 *Feb 26, 2002May 22, 2003Brucker Gregory G.Bifurcated stent and delivery system
US20030114912 *Aug 20, 2002Jun 19, 2003Jacques SequinEndoprosthesis deployment system for treating vascular bifurcations
US20030114915 *Jan 31, 2003Jun 19, 2003Wayne MareiroStent security balloon/balloon catheter
US20030125791 *Oct 28, 2002Jul 3, 2003Jacques SequinNoncylindrical stent deployment system for treating vascular bifurcations
US20030125799 *Dec 28, 2001Jul 3, 2003Limon Timothy A.Intravascular stent and method of use
US20030125802 *Dec 17, 2001Jul 3, 2003Callol Joseph R.Stent for treating bifurcations and method of use
US20030135259 *Jan 17, 2002Jul 17, 2003Scimed Life Systems, Inc.Delivery system for self expanding stents for use in bifurcated vessels
US20030181923 *Dec 17, 2002Sep 25, 2003Gil VardiMethods for deploying stents in bifurcations
US20030195606 *May 27, 2003Oct 16, 2003Advanced Stent Technologies, Inc., A Delaware CorporationBifurcation stent system and method
US20040006381 *May 9, 2003Jan 8, 2004Jacques SequinNoncylindrical drug eluting stent for treating vascular bifurcations
US20040015227 *May 19, 2003Jan 22, 2004Gil VardiExtendible stent apparatus
US20040044396 *Feb 4, 2003Mar 4, 2004Clerc Claude O.Stent and stent-graft for treating branched vessels
US20040049259 *Sep 8, 2003Mar 11, 2004Strecker Ernst PeterEndoprosthesis that can be percutaneously implanted in the patient's body
US20040059406 *Sep 20, 2002Mar 25, 2004Cully Edward H.Medical device amenable to fenestration
US20040072849 *Jul 17, 2003Apr 15, 2004Schreiber Stuart L.Dioxanes and uses thereof
US20040088007 *Nov 5, 2002May 6, 2004Scimed Life Systems, Inc.Assymmetric bifurcated crown
US20040117003 *May 28, 2003Jun 17, 2004The Cleveland Clinic FoundationMinimally invasive treatment system for aortic aneurysms
US20040133268 *Oct 14, 2003Jul 8, 2004Advanced Stent Technologies, Inc.Extendible stent apparatus
US20040138732 *Sep 26, 2003Jul 15, 2004Suhr William S.Apparatus and method for stenting bifurcation lesions
US20040138737 *Aug 21, 2003Jul 15, 2004Advanced Stent Technologies, Inc.Stent with protruding branch portion for bifurcated vessels
US20040148006 *Jan 16, 2004Jul 29, 2004Davidson Charles JStent range transducers and methods of use
US20040172121 *Sep 8, 2003Sep 2, 2004Tracee EidenschinkRotating balloon expandable sheath bifurcation delivery
US20050004656 *Jul 29, 2004Jan 6, 2005Das Gladwin S.Expandable stent having plurality of interconnected expansion modules
US20050010278 *Aug 4, 2004Jan 13, 2005Advanced Stent Technologies, Inc.Extendible stent apparatus
US20050015108 *Apr 29, 2004Jan 20, 2005Advanced Stent Technologies, Inc.Catheter balloon systems and methods
US20050015135 *Aug 17, 2004Jan 20, 2005Conor Medsystems, Inc.Expandable medical device delivery system and method
US20050060027 *Jul 19, 2004Mar 17, 2005Advanced Stent Technologies, Inc.Catheter balloon systems and methods
US20050096726 *Oct 29, 2004May 5, 2005Jacques SequinNoncylindrical stent deployment system for treating vascular bifurcations
US20050102021 *Oct 12, 2004May 12, 2005Cook IncorporatedStretchable prosthesis fenestration
US20050102023 *Dec 14, 2004May 12, 2005Amnon YadinStent with protruding branch portion for bifurcated vessels
US20050119731 *Jan 3, 2005Jun 2, 2005Brucker Gregory G.Bifurcated stent and delivery system
US20050125076 *Dec 17, 2004Jun 9, 2005Ginn Richard S.Lung assist apparatus and methods for use
US20050131526 *Nov 30, 2004Jun 16, 2005Shing-Chiu WongStent and balloon system for bifurcated vessels and lesions
US20050149161 *Dec 29, 2003Jul 7, 2005Tracee EidenschinkEdge protection and bifurcated stent delivery system
US20050154442 *Jan 13, 2004Jul 14, 2005Tracee EidenschinkBifurcated stent delivery system
US20050154444 *Oct 8, 2004Jul 14, 2005Arshad QuadriSystem and method for endoluminal grafting of bifurcated and branched vessels
US20050183259 *Feb 23, 2004Aug 25, 2005Tracee EidenschinkApparatus and method for crimping a stent assembly
US20050209673 *Jul 27, 2004Sep 22, 2005Y Med Inc.Bifurcation stent delivery devices
US20060036315 *Jun 6, 2005Feb 16, 2006Advanced Stent Technologies, Inc.Stent with protruding branch portion for bifurcated vessels
US20060041303 *Aug 18, 2004Feb 23, 2006Israel Henry MGuidewire with stopper
US20060079956 *Aug 10, 2005Apr 13, 2006Conor Medsystems, Inc.Bifurcation stent with crushable end and method for delivery of a stent to a bifurcation
US20060173528 *Jan 10, 2006Aug 3, 2006Trireme Medical, Inc.Stent with self-deployable portion
US20070073376 *Aug 22, 2006Mar 29, 2007Krolik Jeffrey ASteep-taper flared stents and apparatus and methods for delivering them
Referenced by
Citing PatentFiling datePublication dateApplicantTitle
US7892279May 26, 2009Feb 22, 2011Boston Scientific Scimed, Inc.Extendible stent apparatus
US8197536 *Nov 1, 2006Jun 12, 2012Cordis CorporationMethod for placing a medical device at a bifurcated conduit
US8241349Feb 3, 2011Aug 14, 2012Boston Scientific Scimed, Inc.Extendible stent apparatus
US8257419Nov 1, 2006Sep 4, 2012Cordis CorporationApparatus for treating a bifurcated region of a conduit
US9358140Dec 7, 2014Jun 7, 2016Aneuclose LlcStent with outer member to embolize an aneurysm
US20070032855 *Oct 10, 2006Feb 8, 2007Advanced Stent Technologies, Inc.Extendible stent apparatus
US20070219611 *Nov 1, 2006Sep 20, 2007Matthew KreverApparatus for treating a bifurcated region of a conduit
US20080125847 *Nov 1, 2006May 29, 2008Matthew KreverMethod for placing a medical device at a bifurcated conduit
US20100137973 *Nov 10, 2009Jun 3, 2010Boston Scientific Scimed, Inc.Layered Bifurcation Stent
Classifications
U.S. Classification623/1.35
International ClassificationA61F2/82, A61F2/06, A61F2/00
Cooperative ClassificationA61F2002/91525, A61F2250/0098, A61F2002/91533, A61F2250/006, A61F2/852, A61F2/91, A61F2/958, A61F2/954, A61F2002/821, A61F2/915, A61F2/856, A61F2/82, A61F2/064, A61F2002/91516, A61F2002/91508, A61F2002/067, A61F2002/91575, A61F2002/91583, A61F2002/9155, A61F2002/91558, A61F2/07
European ClassificationA61F2/91, A61F2/915, A61F2/954, A61F2/958, A61F2/856
Legal Events
DateCodeEventDescription
May 22, 2009ASAssignment
Owner name: BOSTON SCIENTIFIC SCIMED, INC., MINNESOTA
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:ADVANCED STENT TECHNOLOGIES, INC.;REEL/FRAME:022722/0369
Effective date: 20090515
Owner name: BOSTON SCIENTIFIC SCIMED, INC.,MINNESOTA
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:ADVANCED STENT TECHNOLOGIES, INC.;REEL/FRAME:022722/0369
Effective date: 20090515