US20070173920A1 - Bifurcation stent delivery system - Google Patents

Abstract

The present invention is drawn to a system for deploying a stent at a bifurcation. In one embodiment, the system includes a stepped balloon which has a first section of a first diameter, and a second section of a second diameter. The first portion is sized to deploy a first stent portion, having a larger deployed diameter, while the second portion is sized to deploy a second stent portion, having a smaller deployed diameter.

Description

INCORPORATION BY REFERENCE
• The following patent is hereby fully incorporated by reference:
• U.S. Pat. No. 4,950,227 issued Aug. 21, 1990 to Savin et al. entitled “STENT DELIVERY SYSTEM” and assigned to Boston Scientific Corporation.
REFERENCE TO CO-PENDING APPLICATIONS
• Reference is hereby made to the following co-pending U.S. patent applications:
• U.S. patent application Ser. No. 09/035,652, filed Mar. 5, 1998, entitled “DILATATION AND STENT DELIVERY SYSTEM FOR BIFURCATION LESIONS”;
• U.S. patent application Ser. No. 09/028,792, filed Feb. 24, 1998, entitled “STENTS AND STENT DELIVERY AND DILATATION SYSTEM FOR BIFURCATION LESIONS”;
• U.S. patent application Ser. No. 09/129,472, filed Aug. 4, 1998, entitled “SYSTEM FOR DELIVERING STENTS TO BIFURCATION LESIONS”; and
• U.S. patent application Ser. No. 09/148,179, filed Sep. 4, 1998, entitled “SYSTEM FOR DELIVERING BIFURCATION STENTS”.
BACKGROUND OF THE INVENTION
• The present invention relates to a system for treating vascular disease. More specifically, the present invention relates to a system for deploying a stent in a bifurcation lesion.
• Vascular disease currently represents a prevalent medical condition. Typical vascular disease involves the development of a stenosis in the vasculature. The particular vessel containing the stenosis can be completely blocked (or occluded) or it can simply be narrowed (or restricted). In either case, restriction of the vessel caused by the stenotic lesion results in many well known problems caused by the reduction or cessation of blood circulation through the restricted vessel.
• A bifurcation is an area of the vasculature where a first (or parent) vessel is bifurcated into two or more branch vessels. It is not uncommon for stenotic lesions to form in such bifurcations. The stenotic lesions can affect only one of the vessels (i.e., either of the branch vessels or the parent vessel) two of the vessels, or all three vessels.
• Vascular stents are also currently well known. Vascular stents typically involve a tubular stent which is movable from a collapsed, low profile, delivery position to an expanded, deployed position. The stent is typically delivered using a stent delivery device, such as a stent delivery catheter. In one common technique, the stent is crimped down to its delivery position over an expandable element, such as a stent deployment balloon. The stent is then advanced using the catheter attached to the stent deployment balloon to the lesion site under any suitable, commonly known visualization technique. The balloon is then expanded to drive the stent from its delivery position to its deployed position in which the outer periphery of the stent frictionally engages the inner periphery of the lumen. In some instances, the lumen is predilated using a conventional dilatation catheter, and then the stent is deployed to maintain the vessel in an unoccluded, and unrestricted position.
• Self-expanding stents can also be used. Self-expanding stents are typically formed of a resilient material. The resilient material has sufficient resilience that it can be collapsed to the low profile position and inserted within a delivery device, such as a catheter. Once the catheter is placed at the site of the stenotic lesion, the stent is pushed from within the catheter such that it is no longer constrained in its low profile position. The stent, driven by the resilience of the material, expands to a higher profile, deployed position in which its outer periphery frictionally engages the walls of the stenosed vessel, thereby reducing the restriction in the vessel.
• While there have recently been considerable advances in stent design and stent deployment techniques, current methods of treating bifurcation lesions are suboptimal, particularly where both downstream branch vessels are affected by the lesion. Current techniques of dealing with such lesions typically require the deployment of a slotted tube stent across the bifurcation. However, this compromises the ostium of the unstented branch.
• Further, once the first stent is deployed, the treating physician must then advance a dilatation balloon between the struts of the stent already deployed in order to dilate the second branch vessel. The physician may then attempt to maneuver a second stent through the struts of the stent already deployed, into the second branch vessel for deployment. This presents significant difficulties. For example, dilating between the struts of the stent already deployed tends to distort that stent. Further, deploying the second stent through the struts of the first stent is not only difficult, but it can also distort the first stent. Thus, the current systems used to alternately deploy stents in a bifurcated lesion have significant disadvantages.
• Also, since two guidewires are often used to deploy stents at a bifurcation, the guidewires can become crossed, or somewhat entangled. The deployment systems which are advanced along such guidewires can become caught on the wires, where they cross over one another. This can require additional time and manipulation of the stent deployment system in order to properly deploy the stent at the bifurcation.
• Further, some branch vessels can have somewhat smaller diameter lumens than the parent vessels from which they branch. Therefore, stents of different sizes need to be deployed in the parent vessel and the branch vessel. Alternatively, a single stent having a larger diameter portion, and one or more smaller diameter portions, can be deployed at the bifurcation. However, this can lead to difficulty in deployment. For instance, a balloon which is sized to fit within the smaller diameter stent portion, and deploy that portion, may not be large enough to deploy the larger diameter stent portion. Therefore, a plurality of balloon catheters must be used to deploy such stents.
SUMMARY OF THE INVENTION
• The present invention is drawn to a system for deploying a stent at a bifurcation. In one embodiment, the system includes a stepped balloon which has a first section of a first diameter, and a second section of a second diameter. The first portion is sized to deploy a first stent portion, having a larger deployed diameter, while the second portion is sized to deploy a second stent portion, having a smaller deployed diameter.
• Other embodiments of the present invention include a dual balloon stent deployment catheter, a distal sleeve covering the distal portion of the stent during deployment, and a number of mechanisms for stiffening and torquing the stent deployment device.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 illustrates a typical bifurcation lesion.
• FIGS. 2 and 3 illustrate a stent having two different deployed diameters.
• FIG. 4 illustrates the stent shown inFIGS. 2 and 3 deployed in a bifurcation.
• FIG. 5 illustrates a dual-balloon stent deployment system.
• FIGS. 6A and 6B illustrate deployment of the stent deployment system illustrated inFIG. 5.
• FIG. 7 illustrates another embodiment of a dual-balloon stent deployment system.
• FIGS. 8A and 8B illustrate catching of a distal portion of a stent deployment system on crossed or tangled guidewires.
• FIGS. 9A-9C illustrate a stent deployment system with a distal sleeve disposed thereabout.
• FIG. 10 illustrates another embodiment of a dual-balloon stent deployment system.
• FIGS. 10A-10C illustrate another embodiment of a dual-balloon stent deployment system.
• FIGS. 11A and 11B illustrate another embodiment of a dual-balloon stent deployment system.
• FIGS. 12A-12C illustrate a stepped-balloon stent deployment system.
• FIGS. 13A-13C illustrate a retractable stent deployment system.
• FIGS. 14A-14C illustrate a collapsible embodiment of a stepped balloon stent deployment system.
• FIGS. 15A-15C illustrate stiffening and torquing systems for use with a stent deployment system.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
• FIG. 1 illustratesbifurcation10 which includesparent vessel12,first branch vessel14 andsecond branch vessel16.FIG. 1 also illustrates that abifurcation lesion18 has developed inbifurcation10. As illustrated,lesion18 extends into bothbranch vessels14 and16, and extends slightly intoparent vessel12 as well.Lesion18 may also be located on only one side of thebranch vessel14 or16. In either case, it is preferable to stent bothbranch vessels14 and16 to avoid collapsing one. In order to treatbifurcation lesion18, it may commonly first be predilated with a conventional angioplasty balloon catheter dilatation device.
• FIG. 2 is a side view of astent20 which can be used to treat a portion ofbifurcation10.Stent20 includes afirst portion22 and asecond portion24.First portion22 has a relatively large deployed diameter, whilesecond portion24 has a somewhat smaller deployed diameter.
• FIG. 3 is an end view ofstent20 taken as indicated by arrows3-3 inFIG. 2. In one illustrative embodiment,portions22 and24 ofstent20 are simply discrete stents which have been interwoven, or attached, to one another. Alternatively,stent20 can be formed by one integral stent formed withportions22 and24 being integral with one another. In either case,stent20 can preferably be deformed to a low profile, collapsed (or deployment) position in which it can be inserted throughparent vessel12 tobifurcation10.Stent20 is then deployed, either using its own resilience, or using a balloon deployment system, to its expanded, deployed position illustrated inFIG. 2.
• FIG. 4 illustratesstent20 deployed inbifurcation10. InFIG. 4, first andsecond guidewires26 and28 are first inserted, throughparent vessel12, to bifurcation10 such thatguidewire26 has a distal end residing inbranch vessel14 whileguidewire28 has a distal end residing inbranch vessel16. Using a stent deployment system, such as any of those described in greater detail later in the specification,stent20 is advanced in a low profile, insertion position to the location illustrated inFIG. 4.Stent20 is then deployed by expandingportions22 and24 to the deployed positions illustrated inFIG. 4. In one illustrative embodiment,portion24 has an outer diameter which, when deployed, frictionally engages the inner diameter ofbranch vessel14. Similarly,portion22 has an outer diameter which, when deployed, is sufficient to frictionally engage the inner diameter ofparent vessel12, to remain in place inbifurcation10.
• FIG. 5 is a side view of a dual-balloonstent deployment system30 in accordance with one aspect of the present invention.System30 is shown with a cross-section ofstent20, in the deployed position, disposed thereon.System30 includes aproximal catheter32 having alumen34 disposed therein. First and second guidewire lumens (or tubes)36 and38 extend from withinlumen34 and extend todistal ends40 and42.System30 also includes a first,proximal balloon44 and a second,distal balloon46.Balloon44 has aproximal end48 which is sealed to the distal end ofcatheter32. Whileproximal end48 ofballoon44 can be sealed to either the outer or inner side ofcatheter32, it is illustrated inFIG. 5 as being sealed to the outer surface ofcatheter32, using, for example, an adhesive.Balloon44 also has adistal end50 which is sealed, with a fluid tight seal, aboutguidewire tube36 and a portion of theproximal end52 ofballoon46.
• Balloon46 includes aproximal end52 which is also fluidly sealed partially to an inside surface or the distal waist ofballoon44 and partially toguidewire lumen38. However, aninflation lumen54 extends from the interior ofballoon44, through theproximal end52 ofballoon46, and communicates with the interior orballoon46.Balloon46 further includes adistal end56 which is sealed to the outer surface ofguidewire lumen42. Therefore, an inflation lumen for inflatingballoons44 and46 is defined by lumen34 ofcatheter42, andlumen54 disposed about at least a portion ofguidewire tubes36 and38.
• Guidewire lumen38 extends fromlumen34 distally through bothballoons44 and46, and protrudes out thedistal end56 ofballoon46.Guidewire lumen36, on the other hand (and as will be disclosed in greater detail later in the specification) is used to track a guidewire which extends down a branching vessel.Guidewire lumen38 has adistal end40 which extends out from within thedistal end50 ofballoon44, and extends to a position outside ofballoon46. Both balloons44 and46 can preferably be collapsed to a low profile, insertion position. However,balloon44 has a relatively large inflated diameter for driving deployment of thelarger diameter portion22 ofstent20.Balloon46, on the other hand, has a smaller inflated diameter for driving deployment of the smallerdiameter stent portion24 ofstent20.
• FIGS. 6A and 6B illustrate the deployment ofstent20 utilizingsystem30 illustrated inFIG. 5.FIG. 6A illustratessystem30 in the insertion position. First, guidewires26 and28 are advanced through the vasculature tobifurcation10, such that they reside withinbranch vessels14 and16, respectively. It should be noted thatsystem30 can be backloaded ontoguidewires26 and28. In that case, prior to insertingguidewires26 and28,system30 is loaded onto the guidewire such that guidewire26 resides withinguidewire tube38 whileguidewire28 resides withintube30. Alternatively,system30 can be loaded ontoguidewires26 and28 from the proximal end of the guidewires. In either case, after the guidewires are positioned appropriately,system30 is advanced usingcatheter32 through the vasculature (and may be advanced through a guide catheter58) tobifurcation10.System30 is then further advanced such thatstent portion24 followsguidewire26 and resides withinbranch vessel14.
• Once in the position illustrated inFIG. 6A, fluid is introduced intoballoons44 and46 throughcatheter32, to inflate the balloons. This drivesstent portions22 and24 ofstent20 into the deployed position illustrated inFIG. 6B. In the deployed position, the outer diameter ofstent portions22 and24 are sufficient to frictionally engage the interior vessel walls ofparent vessel12 andbranch vessel14, respectively, such thatstent20 is frictionally held in place inbifurcation10. Thelumens44 and46 are then deflated, andsystem30 is removed from withinstent20.Guidewires26 and28 are then removed frombifurcation10, leavingstent20 deployed in place.
• System30 preferably employsballoons44 and46 which have steep proximal and distal cone angles in order to reduce any gap between the balloons. this increases the ability to exert adequate deployment force onstent portions22 and24. Similarly, post delivery dilatation may be used in order to further dilate the lesion from within the deployedstent20.
• FIG. 7 illustrates a side view of another embodiment of a dual-balloonstent deployment system60 in accordance with one aspect of the present invention.System60 has a number of items which are similar tosystem30 shown inFIG. 5, and those items are similarly numbered inFIG. 7.System60 includes aproximal balloon62 which has aproximal end64 and adistal end66. Theproximal end64 inballoon62 is sealed about the distal end ofcatheter32. The interior ofballoon62 communicates withlumen34 ofcatheter32. Thedistal end66 ofballoon62 is formed in a cone configuration. A radially interior portion is sealed aboutguidewire tubes36 and38, leaving aninflation lumen68 therebetween, which communicates with the interior ofballoon46. The radial outward portion of thedistal end66 ofballoon62, when inflated, assumes an outer diameter which is substantially the same as the maximum diameter of the remainder ofballoon62. However, thedistal end66 is formed in a reverse cone shape such that the radial outward portion of thedistal end66 is substantially tubular in shape. The balloon tapers proximally along aportion70 to the inner diameter portion ofballoon62.
• In this way, the outer diameter ofballoon62 obtains a substantially greater size, at its extreme distal end, thanballoon44 insystem30. This assists in deployingportion22 ofstent20. Again, post-delivery dilatation may be used to furtheradvance stent portions22 and24 toward the wall ofvessels12 and14, respectively.Stent deployment system60 is deployed in a similar fashion asstent deployment system30, illustrated with respect toFIGS. 6A and 6B.
• FIGS. 8A and 8B illustrate a problem which can be encountered in deploying a stent in a bifurcation.FIG. 8A illustrates astent deployment system72 located just proximally ofbifurcation10.Stent deployment system72 includes adistal stent portion74 which has adistal end76.FIG. 8A also illustrates thatguidewires26 and28 are crossed over one another in across-over region78. Asdeployment system72 is advanced distally, thedistal end76 ofstent portion74 encounters cross overregion78.FIG. 8B illustrates that thedistal end76 ofstent portion74 can actually catch, and hang up on, a portion ofguidewire28 which is crossed overguidewire26. This makes it very difficult, if not impossible, to continue to advancestent deployment system72 distally overguidewires26 and28. Instead,system72 must be withdrawn proximally, and theguidewires26 and28 must be remanipulated ordeployment system72 must be torqued (rotated about its longitudinal axis) or otherwise maneuvered, in an attempt to loosenguidewire28 from thedistal end76 ofstent portion74.
• FIG. 9A illustratesstent deployment system60, as discussed with respect toFIG. 7, but with the addition of adistal sleeve80 or aproximal sleeve82 or both disposed about the distal end ofstent portion24 and the proximal end ofstent portion22, respectively.Distal sleeve80 andproximal sleeve82 are provided in order to minimize the likelihood that the longitudinal ends ofstent20 will catch or engage any unwanted obstacles, such as tissue or guidewires. Thesleeves80 and82 are described in greater detail in U.S. Pat. No. 4,950,227, which is fully incorporated herein by reference. Briefly,sleeves80 and82 are illustratively formed of silicone and are approximately 2 cm in length.Sleeve80 is fixed to thedistal end42 ofguidewire lumen38 using adhesive or welding. Similarly, the proximal end ofsleeve82 is fixed to the distal end ofcatheter32, using a suitable adhesive. Such adhesive may, for example, be comprised of a urethane bead.Sleeves80 and82overlap stent portions24 and22, respectively, by a distance which is approximately 3 mm. Further, in one embodiment,sleeves80 and82 have tapered distal edges. In a further embodiment,sleeves80 and82 have tapered distal and proximal edges. This facilitates the transfer ofsystem60 within the vasculature, while decreasing the tendency to catch or engage undesired obstacles.
• FIGS. 9B and 9C illustrate the deployment ofstent portion24 and the interaction ofstent portion24 withsleeve80. A similar interaction is obtained betweensleeve82 and the proximal end ofstent portion22. Asstent portion24 is deployed,balloon46 is inflated and the distal end ofstent portion24 is released from withinsleeve80. This is illustrated inFIG. 9B. Then, afterstent portion24 is deployed andballoon46 is deflated (and thus radially retracted)sleeve80 contracts about the distal end ofballoon46. The deflation ofballoon46 facilitates removal ofballoon46, as well assleeve80, from within the deployedstent portion24, asdeployment system60 is axially removed from the vasculature. It should be noted thatsleeves80 and82 can be used on substantially any of the embodiments described herein.
• FIG. 10 illustrates another dual-balloonstent deployment system90 in accordance with one aspect of the present invention.System90 includes anouter sheath92, aninner sheath94 defining aninflation lumen96, a plurality ofguidewire lumens98 and100, each having distal ends102 and104, respectively.System90 also includesfirst balloon106 andsecond balloon108.First balloon106 has adistal end110 which is sealed about the outer surface ofguidewire lumen102.Balloon106 also has aproximal end112 which is sealed within adisc114 which is sealed (such as through adhesive) to the inside of the distal end ofcatheter94.Balloon108 has adistal end116 which is sealed about the outer surface ofguidewire lumen104, and aproximal end118 which is sealed withindisc114. The interior ofballoons106 and108 are in fluid communication with thelumen96 formed byinner catheter94. This provides an arrangement to provide fluid under pressure to inflateballoons106 and108. It should be noted that, instead of usingdisc114, the inside of the distal end ofcatheter94 can simply be filled with adhesive using a technique commonly referred to as potting.
• Balloons106 and108 can either have the same, or different, deployed diameters. However,balloon108 may have a greater longitudinal length thanballoon106. Therefore,stent portion22 ofstent20 can be deployed by inflating bothballoons106 and108 to drivestent portion22 into its higher profile, deployed position. By contrast,stent portion24 is disposed only about the distal part ofballoon108, distal ofballoon106. Thus,stent portion24 is deployed by the inflation ofballoon108.System90 is used to deploystent20 in a similar fashion to that described with respect tosystem30 inFIGS. 6A and 6B.
• FIGS. 10A-10C illustrate anotherstent deployment system120.System120 is similar tosystem90 illustrated inFIG. 10, and similar items are similarly numbered. However, rather than having adisc114 disposed at the distal end ofcatheter94,system120 has a plug member122 (which is also illustrated inFIGS. 10B and 10C).Plug member122 has an exterior surface which snugly fits within the interior of the distal end ofcatheter94, and is secured therein, such as by frictional fit or suitable adhesive.Plug member122 also has generallytubular extensions124 and126 which extend from abody128 thereof. A pair oflumens130 and132 extend throughbody128 and throughextension members124 and126, respectively.Lumens130 and132 are larger thanguidewire lumens98 and100 such that guidewirelumens98 and100 can pass therethrough, and still leave an area which provides fluid communication betweenlumen96 ofcatheter94 and the interior ofballoons106 and108, respectively. This provides a mechanism by which balloons106 and108 can be inflated through the infusion of pressurized fluid throughlumen96 incatheter94.
• In addition, the proximal ends112 and118 ofballoons106 and108 are illustratively fastened about the exterior ofextension members124 and126, respectively. Such fastening can take any suitable form, such as through adhesive.
• FIGS. 11A and 11B illustrate yet another embodiment of astent deployment system138 in accordance with another aspect of the present invention.System138 includes afirst balloon140 and asecond balloon142. Each balloon is disposed about aguidewire lumen144 and146, respectively. Aproximal catheter148 is provided with twoseparate inflation lumens150 and152.Inflation lumen150 is provided to inflateballoon140 whileinflation lumen152 is provided to inflateballoon142. The proximal end ofballoons140 and142 are sealably connected aboutinflation lumens150 and152 andguidewire lumens144 and146.
• Similarly,catheter148 is also provided with a stiffeningmember154. Stiffeningmember154 is preferably a stiffening wire (or a pair of stiffening wires or a hypotube) which runs at least through a distal portion ofcatheter148, and is fastened thereto, to provide increased pushability, and increased torquability.
• FIG. 11B is a cross-sectional view ofcatheter148 taken along section lines11B-11B shown inFIG. 11A.FIG. 11B shows that, in one illustrative embodiment,catheter148 includes a pair of stiffeningmembers154A and154B which are either embedded within, or fixedly secured to, the wall ofcatheter148. Similarly,FIG. 11B better illustrates thatinflation lumens150 and152 are generally kidney-shaped (or shaped in a generally hemispherical shape) and extend partially about theguidewire lumens144 and146, respectively.System138 is used to deploystent20 in a fashion similar tosystem30 illustrated inFIGS. 6A and 6B.
• FIG. 12A is a side view of another embodiment of astent deployment system160 in accordance with one aspect of the present invention.System160 includes acatheter162 with alumen164 therein. Aguidewire lumen166 extends throughlumen164 to adistal end168 of the guidewire lumen.System160 also includes a steppedballoon170. Steppedballoon170 has adistal end172 sealably connected about the outer surface ofguidewire lumen168.Balloon170 also has aproximal end174 sealably connected about the external surface ofcatheter162. In addition,balloon170 has afirst portion176 which has a first inflated outer diameter and asecond portion178 which has a second inflated outer diameter, less than the first inflated outer diameter ofportion176.Balloon170 has astep region180 which defines the transition betweenportion176 and178. Thestep region180, in the embodiment illustrated inFIG. 12A, is simply a steeply tapering portion which extends from the inflated outer diameter ofballoon portion178 to the inflated outer diameter ofballoon portion176.Balloon170 is preferably formed of a conventional balloon material preformed into the stepped shape illustrated generally inFIG. 12A.
• Thus,stent20 can be deployed using only asingle balloon170. The smallerdiameter stent portion24 is disposed overballoon portion178, while the larger diameterballoon stent portion22 is disposed overballoon portion176.
• FIG. 12B illustrates another steppedballoon182.Balloon182 also includes first andsecond portions184 and186. However, the step inballoon182 is generally concentric, rather than eccentric as described with respect toFIG. 12A.FIG. 12C illustratesballoon182 disposed withinbifurcation10. In one illustrative embodiment,stent20 hassection22, which is weaker thansection24. Due to the strength ofstent20, the step inballoon182 moves or shifts from being concentric, to being non-concentric, as illustrated inFIG. 12C. The eccentricity shifts towards the open cell (or weaker section) ofstent22.
• FIGS. 13A-13C illustrate anotherstent deployment system190 in accordance with one aspect of the present invention.Deployment system190 includes steppedballoon182 with aguidewire lumen192 extending therethrough.Stent20 is disposed aboutballoon182. In addition, withinstent portion22, and on the exterior ofballoon182, is provided asecond guidewire lumen194. Aproximal catheter196 is coupled to fluidly communicate with the interior ofballoon182. Apull wire198 is coupled to the proximal end ofguidewire lumen194 and to apull sleeve200 slidably disposed aboutcatheter196, generally at the proximal end ofcatheter196.
• FIGS. 13A and 13B illustrate the insertion ofsystem190 for deployment ofstent20.FIG. 13B illustrates thatsystem190 is advanced through the vasculature overguidewires26 and28 such that the distal end of balloon182 (and stent portion24) resides withinbranch vessel14.Stent20 is deployed under relatively low pressure to pre-dilate the stent. Next,guidewire lumen194 is withdrawn proximally in the direction indicated byarrow202, by user withdrawal ofsleeve20 proximally overcatheter196.
• Balloon182 is then further inflated to a relatively high pressure to post-dilate the stent, as illustrated inFIG. 13C. This acts to deploystent20 outwardly causing the outer surface ofstent20 to frictionally engage the interior surface ofparent vessel12 inbranch vessel14.Balloon182 is then deflated and the system is withdrawn from the vasculature, leavingstent20 in place inbifurcation10.
• FIGS. 14A-14C illustrate anotherstent deployment system210 in accordance with one aspect of the present invention.System210 is similar tosystem190 described with respect toFIGS. 13A-13C, and similar items are similarly numbered. However,system210 allowsguidewire lumen194 to remain in place,adjacent balloon182, during deployment ofstent20. Therefore, rather than having aremovable guidewire lumen194,system210 includesguidewire lumen212. As insystem190,guidewire lumen212 resides withinportion22 ofstent20, but on the exterior ofballoon182.
• FIG. 14B illustrates thatsystem210 is inserted withinbifurcation10 in a manner similar to system190 (illustrated inFIG. 13B). However,guidewire lumen212 remains in place during inflation ofballoon182, as shown inFIG. 14C. In one preferred embodiment, at least thedistal portion214 ofguidewire lumen212 is collapsible. Therefore, asballoon182 is inflated, the distal portion214 (which resides within stent20) ofguidewire lumen212 collapses against the inner wall ofstent portion22, aboutguidewire28. The exterior periphery ofballoon182 drives deployment ofstent portion22, by exerting pressure on thecollapsible portion214 ofguidewire lumen212.
• In another embodiment, thedistal portion214 ofguidewire tube212 is substantially rigid. Whenballoon182 is inflated,tube212 stays in place. Therefore, inflation ofballoon182 exerts pressure ontube212 causingstent portion22 to deploy radially outwardly.
• FIGS. 15A-15C illustrate another embodiment of the present invention. For purposes of the present discussion,system210 illustrated with respect toFIGS. 14A-14C is illustrated inFIG. 15A, along with atorquing system220. However, it will be appreciated that torquingsystem220 can be used with substantially any of the other embodiments discussed herein.
• Torquing system220 includes ashaft222 disposed aboutguidewire lumen212 andcatheter196.System220 also includes aslidable sleeve224 which is slidably engageable with the exterior surface ofshaft222.Sleeve224 is preferably substantially rigid when compared with, for example,catheter196. Whensleeve224 slidably engages the surface ofshaft222, the user can torque or rotatesleeve222 and thus substantially increase the torquability (or rotatability) ofstent deployment system210.
• FIG. 15B is a rear perspective view of one embodiment ofshaft222 andsleeve224. In one embodiment,shaft222 is a relatively flexible and resilient shaft, made of suitable polymer material which is commercially available and conventionally used to make percutaneous catheters. However,shaft222 includes flattened wall surfaces226 disposed on generally opposite sides thereof.Sleeve224 is either a full hypotube, or a portion thereof, which also has flattenedsides228 which are spaced from one another just far enough to slidably receive the flattenedsurfaces226 ofshaft222. Therefore, when the user advancessleeve224 distally such that thesides228 engagesurfaces226, the user can more easilytorque system210.
• FIG. 15C illustrates an alternative embodiment ofshaft222 andsleeve224. In the embodiment illustrated inFIG. 15C,shaft222 has one ormore slots230 defined about the perimeter thereof. Similarly,sleeve224 has corresponding radially inwardly directedprotrusions232 disposed thereabout.Protrusions232 are sized just smaller thanslots230. Therefore, as the user slidessleeve224 distally,protrusions232 slidably engage, and slide within,slots230. Sincesleeve224 is made of a relatively rigid material, it can be used to torque, or steer,system210 within the vasculature.
• Thus, it can be seen that the present invention provides a system for deploying a stent at a bifurcation. The system includes a variety of dual-balloon delivery and deployment systems. In another embodiment, the system includes a stepped balloon arrangement. Further, in another embodiment, the system includes a mechanism by which torquability can be increased to make positioning of the stent delivery system within the vasculature much easier.
• Although the present invention has been described with reference to preferred embodiments, workers skilled in the art will recognize that changes may be made in form and detail without departing from the spirit and scope of the invention.

Claims (90)

1-24. (canceled)

25. A balloon catheter for use in treating a vascular bifurcation, comprising:

(a) a catheter shaft having a distal end portion; and

(b) a stepped balloon positioned at the distal end portion of the catheter shaft, the stepped balloon including;

(i) a proximal portion having an outer surface that defines a first average diameter, the proximal portion defining a proximal end portion of the stepped balloon, the proximal portion configured for placement at a proximal portion of the vascular bifurcation;

(ii) a distal portion having an outer surface that defines a second average diameter, the second average diameter being smaller than the first average diameter, the distal portion defining a distal end portion of the stepped balloon, the distal portion configured for placement at a distal portion of the vascular bifurcation; and

(iii) a transition portion extending between the first and second portions.

26. The balloon catheter ofclaim 25, wherein the second average diameter is at least one half the value of the first average diameter.

27. The balloon catheter ofclaim 25, wherein the proximal and distal portions are concentric.

28. The balloon catheter ofclaim 25, wherein the first average diameter is substantially the same along an entire length of the first portion.

29. The balloon catheter ofclaim 25, wherein the second average diameter is substantially the same along an entire length of the second portion.

30. The balloon catheter ofclaim 25, wherein at least a portion of the first portion is tapered.

31. The balloon catheter ofclaim 35, wherein at least a portion of the second portion is tapered.

32. The balloon catheter ofclaim 25, wherein the balloon catheter is configured for use with a stent for a stent delivery application.

33. The balloon catheter ofclaim 25, wherein the first section has a larger length than a length of the second section.

34. The balloon catheter ofclaim 25, wherein a length of the second portion is greater than a length of the first portion.

35. The balloon catheter ofclaim 25, wherein the lengths of the first and second portions are about the same.

36. A balloon catheter assembly for use in a vascular anatomy, the assembly comprising:

(a) a catheter shaft having a distal end portion and defining an inflation lumen; and

(b) a balloon extending from the distal end portion of the catheter shaft, the balloon having a shaped outer geometry that includes:

(i) a first portion having a first diameter, the first portion defining a proximal end portion of the balloon; and

(ii) a second portion having a second diameter that is less than the first diameter, the second portion defining a distal end portion of the balloon.

37. The balloon catheter ofclaim 36, wherein the second average diameter is at least one half the value of the first average diameter.

38. The balloon catheter ofclaim 36, wherein the proximal and distal portions are concentric.

39. The balloon catheter ofclaim 36, wherein the shaped outer geometry of the balloon further includes a transition portion extending between the first and second portion of the balloon, the transition portion defining a tapered surface that extends non-parallel with each of the first and second portions.

40. The balloon catheter ofclaim 36, further comprising a guidewire member defining a guidewire lumen, the guidewire member extending through a portion of the catheter shaft and distally beyond the distal end portion of the catheter shaft, a distal end portion of the balloon mounted to a distal end portion of the guidewire.

41. The balloon catheter ofclaim 36, further comprising a stent, the stent having opposing distal and proximal open ends, the balloon extending through the stent between the distal and proximal open ends.

42. The balloon catheter ofclaim 36, wherein the balloon further includes a transition portion, the transition portion extending between the first and second portions of the balloon.

43. A method of treating a vascular bifurcation or side-branch anatomy with a balloon catheter, the balloon catheter including a balloon having a first balloon portion, a second balloon portion, and a transition portion, the first and second balloon portions having different outer diameters, the method comprising:

mounting a stent in a unexpanded state on an exterior of the balloon;

positioning the balloon with the stent in a unexpanded state at a vascular bifurcation with the first balloon portion extending proximal of the vascular bifurcation and the distal balloon portion extending distal of the vascular bifurcation;

inflating the balloon to expand the stent into an expanded state at the vascular bifurcation; and

removing the balloon catheter from the vascular bifurcation.

44. The method ofclaim 43, wherein the step of positioning the balloon includes aligning the transition portion of the balloon with features of the vascular bifurcation prior to inflating the balloon.

45. A catheter balloon, comprising:

(a) a proximal portion having an outer surface that defines a first average diameter, the proximal portion defining a proximal end portion of the stepped balloon, the proximal portion configured for placement at a proximal portion of the vascular bifurcation;

(b) a distal portion having an outer surface that defines a second average diameter, the second average diameter being smaller than the first average diameter, the distal portion defining a distal end portion of the stepped balloon, the distal portion configured for placement at a distal portion of the vascular bifurcation; and

(c) a transition portion that extends from the proximal portion to the distal portion.

46. The catheter balloon ofclaim 45, wherein the balloon is configured for use with a stent that is expanded upon inflation of the balloon.

47. The catheter balloon ofclaim 45, wherein the first section has a greater length than a length of the second section.

48. The catheter balloon ofclaim 45, wherein a length of the second portion is greater than a length of the first portion.

49. The catheter balloon ofclaim 45, wherein the lengths of the first and second portions are about the same.

50. A balloon catheter for use in a vascular bifurcation or side-branch anatomy, comprising:

a catheter body; and

a balloon positioned at a distal portion of the catheter body, the balloon including a balloon outer skin, a first lumen adapted to receive a guidewire and a second lumen configured to provide inflation and deflation of the balloon, the balloon having a first section with a first average diameter, and second section with a second average diameter that is smaller than the first average diameter, the first and second sections being coupled by a transition section that has a geometry and is sized to reduce vessel damage when position at a point of vessel bifurcation.

51. The catheter ofclaim 50, further comprising: a radiopaque marker positioned at the balloon.

52. The catheter ofclaim 51, wherein the radiopaque marker is positioned at the transaction section.

53. The catheter ofclaim 51, wherein the radiopaque marker is positioned at a location that provides an indication of a bifurcation or side-branch position in a vascular anatomy.

54. The balloon catheter ofclaim 50, wherein the balloon is made of any suitable polymer, non-polymer or composite material thereof.

55. The balloon catheter ofclaim 50, wherein the first average diameter is substantially the same along an entire length of the first section.

56. The balloon catheter ofclaim 50, wherein the second average diameter is substantially the same along an entire length of the second section.

57. The balloon catheter ofclaim 50, wherein the second lumen includes an inflation and deflation aperture positioned in the first section.

58. The balloon catheter ofclaim 50, wherein the second lumen includes an inflation and deflation aperture positioned in the first section.

59. The balloon catheter ofclaim 50, wherein at least a portion of the first section is tapered.

60. The balloon catheter ofclaim 50, wherein at least a portion of the second section is tapered.

61. The balloon catheter ofclaim 50, wherein a radiopaque marker is positioned at a proximal section of the balloon.

62. The balloon catheter ofclaim 50, wherein a radiopaque marker is positioned at a distal portion of the balloon.

63. The balloon catheter ofclaim 50, wherein the catheter body is part of an over-the-wire catheter system.

64. The balloon catheter ofclaim 50, wherein the catheter body is part of a rapid-exchange catheter system.

65. The balloon catheter ofclaim 50, wherein the balloon catheter is configure for use in an angioplasty application in a vessel with a stenting procedure.

66. The balloon catheter ofclaim 50, wherein the balloon catheter is configure for use in an angioplasty application in a vessel without a stenting procedure.

67. The balloon catheter ofclaim 50, wherein the balloon catheter is configured for use with a stent for a stent delivery application.

68. The balloon catheter ofclaim 50, wherein the balloon catheter is used as a stent delivery system with a stent designed for a bifurcation or side branch vascular anatomy.

69. The balloon catheter ofclaim 50, wherein the first section has a larger length than a length of the second section.

70. The balloon catheter ofclaim 50, wherein a length of the second is greater than a length of the first section.

71. The balloon catheter ofclaim 50, wherein the lengths of the first and second sections are about the same.

72. An angioplasty balloon catheter for use in a vascular anatomy, comprising: an angioplasty catheter body; and

a tubular balloon coupled to a distal end of the angioplasty catheter body and including, a shaped balloon skin, a catheter shaft with a first lumen configured to receive a guidewire and a second lumen configured to be provide inflation-deflation of the balloon, the balloon having a shaped outer geometry and size to reduce vessel damage when position at a point of vessel bifurcation.

73. The balloon catheter ofclaim 72, further comprising: a radiopaque marker positioned at the tubular balloon.

74. The catheter ofclaim 73, wherein the radiopaque marker is positioned at a location that provides an indication of a bifurcation or side-branch position in a vascular anatomy.

75. The balloon catheter ofclaim 72, wherein the balloon is made of any suitable polymer, non-polymer or composite material thereof.

76. The balloon catheter ofclaim 72, wherein the balloon includes a first section with a first average diameter, and a second section with a second average diameter.

77. The balloon catheter ofclaim 76, wherein the first average diameter is substantially the same along an entire length of the first section.

78. The balloon catheter ofclaim 76, wherein the second average diameter is substantially the same along an entire length of the second section.

79. The balloon catheter ofclaim 76, wherein the second lumen includes an inflation and deflation aperture positioned in the first section.

80. The balloon catheter ofclaim 76, wherein the second lumen includes an inflation and deflation aperture positioned in the first section.

81. The balloon catheter ofclaim 76, wherein at least a portion of the first section is tapered.

82. The balloon catheter ofclaim 76, wherein at least a portion of the second section is tapered.

83. The balloon catheter ofclaim 72, wherein a radiopaque marker is positioned at a proximal section of the balloon.

84. The balloon catheter ofclaim 72, wherein a radiopaque marker is positioned at a distal portion of the balloon.

85. The balloon catheter ofclaim 72, wherein the catheter body is part of an over-the-wire catheter system.

86. The balloon catheter ofclaim 72, wherein the catheter body is part of a rapid-exchange catheter system.

87. The balloon catheter ofclaim 72, wherein the balloon catheter is configure for use in an angioplasty application in a vessel with a stenting procedure.

88. The balloon catheter ofclaim 72, wherein the balloon catheter is configure for use in an angioplasty application in a vessel without a stenting procedure.

89. The balloon catheter ofclaim 72, wherein the balloon catheter is configured for use with a stent for a stent delivery application.

90. The balloon catheter ofclaim 72, wherein the balloon catheter is used as a stent delivery system with a stent designed for a bifurcation or side branch vascular anatomy.

91. The balloon catheter ofclaim 76, wherein the first section has a larger length than a length of the second section.

92. The balloon catheter ofclaim 76, wherein a length of the second is greater than a length of the first section.

93. The balloon catheter ofclaim 76, wherein the lengths of the first and second sections are about the same.

94. A stent delivery device, comprising:

a catheter body;

a balloon positioned at a distal portion of the catheter body, the balloon including a balloon outer skin, a first lumen adapted to receive a guidewire and a second lumen configure to provide inflation and deflation of the balloon, the balloon having a first section with a first average diameter, and second section with a second average diameter that is smaller than the first average diameter, the first and second sections being coupled by a transition section that has a geometry and is sized to reduce vessel damage when position at a point of vessel bifurcation; and

a vascular stent positioned on an exterior of the balloon exterior.

95. The device ofclaim 94, further comprising: a radiopaque marker positioned at the balloon.

96. The device ofclaim 95, wherein the radiopaque marker is positioned at the transaction section.

97. The device ofclaim 95, wherein the radiopaque marker is positioned at a location that provides an indication of a bifurcation or side-branch position in a vascular anatomy.

98. The device ofclaim 94, wherein the balloon is made of any suitable polymer, non-polymer or composite material thereof.

99. The device ofclaim 94, wherein the first average diameter is substantially the same along an entire length of the first section.

100. The device ofclaim 94, wherein the second average diameter is substantially the same along an entire length of the second section.

101. The device ofclaim 94, wherein the second lumen includes an inflation and deflation aperture positioned in the first section.

102. The device ofclaim 94, wherein the second lumen includes an inflation and deflation aperture positioned in the first section.

103. The device ofclaim 94, wherein at least a portion of the first section is tapered.

104. The device ofclaim 94, wherein at least a portion of the second section is tapered.

105. The device ofclaim 94, wherein a radiopaque marker is positioned at a proximal section of the balloon.

106. The device ofclaim 94, wherein a radiopaque marker is positioned at a distal portion of the balloon.

107. The device ofclaim 94, wherein the catheter body is part of an over-the-wire catheter system.

108. The device ofclaim 94, wherein the catheter body is part of a rapid-exchange catheter system.

109. The device ofclaim 94, wherein the device is used for a bifurcation or side branch vascular anatomy.

110. The device ofclaim 94, wherein the first section has a larger length than a length of the second section.

111. The device ofclaim 94, wherein a length of the second is greater than a length of the first section.

112. The device ofclaim 94, wherein the lengths of the first and second sections are about the same.

113. A method of treating a vascular bifurcation or side-branch anatomy, comprising:

providing a catheter that includes a balloon with a transition section that couples a first section with a second section, the transition section having a geometry and size to reduce vessel damage when position at a point of vessel bifurcation;

mounting a stent in a non-expanded on an exterior of the balloon;

positioning the catheter with the stent in a non-expanded state at a vascular bifurcation or a vascular side-branch site;

inflating the balloon and deploying the stent in an expanded state at the vascular bifurcation or vascular side-branch site; and

removing the catheter from the vascular bifurcation or a vascular side-branch site.

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