Source: https://patents.google.com/patent/CA2545588A1/en
Timestamp: 2019-04-20 00:34:33+00:00

Document:
2004-11-10 Application filed by Advanced Stent Technologies, Inc., Amnon Yadin filed Critical Advanced Stent Technologies, Inc.
 Pursuant to 35 U.S.C. ~ 1.19(e), this application claims the benefit of priority of U.S. Provisional Application No. 60/518,870 filed November 12, 2003; U.S.
Provisional Application No. 60/547,778 filed February 27, 2004; U.S.
Provisional Application No. 60/548,868 filed March 2, 2004, co-pending U.S. Patent Application No. 10/705,247, filed November 12, 2003, co-pending U.S. Patent Application No.
10/802,036, filed March 17, 2004, co-pending U.S. Patent Application No.
10/834,066, filed April 29, 2004; and co-pending U.S. Patent Application No.
10/893,278, filed July 19, 2004. The complete disclosures of the above-referenced applications are incorporated herein by reference.
 Balloon catheters, with or without stems, are used to treat strictures, stenoses, or narrowings in various parts of the human body. Devices of numerous designs have been utilized for angioplasty, stems and grabs or combination stent/grafts.
 In many cases, a stent or other prosthesis must be implanted to provide support for the artery. When such a device is to be implanted, a balloon catheter which carries a stent on its balloon is deployed at the site of the stenosis. The balloon and accompanying prosthesis are positioned at the location of the stenosis, and the balloon is inflated to circumferentially expand and thereby implant the prosthesis.
Thereafter, the balloon is deflated and the catheter and the guidewire are withdrawn from the patient.
 Administering PTCA and/or implanting a stmt at a bifurcation in a body lumen poses further challenges for the effective treatment of stenoses in the lumen.
For example, dilating a main vessel at a bifurcation may cause narrowing of the adjacent branch vessel. In response to such a challenge, attempts to simultaneously dilate both branches of the bifurcated vessel have been pursued. These attempts include deploying more than one balloon, more than one prosthesis, a bifurcated prosthesis, or some combination of the foregoing. However, simultaneously deploying multiple and/or bifurcated balloons with or without endoluminal prostheses, hereinafter individually and collectively referred to as a bifurcated assembly, requires accurate placement of the assembly. Deploying multiple stems requires positioning a main body within the main vessel adjacent the bifurcation, and then attempting to position another stmt separately into the branch vessel of the body lumen. Alternatives to that include deploying a dedicated bifurcated stmt including a tubular body or trunk and two tubular legs extending from the trunk. Some examples include U.S. Patent No. 5,723,004 to Dereume et al., U.S. Patent No. 4,994,071 to MacGregor, and U.S. Patent No. 5,755,734 to Richter et al.
 Additional bifurcation stmt delivery systems that provide improved reliable treatment at bifurcations are disclosed, for example, in U.S. Patent No.
6,325,826 to Vardi et al. and U.S. Patent No. 6,210,429 to Vardi et al. The contents of the '826 and '429 patents aforementioned patents are incorporated herein by reference.
 A need still exists for further improved devices and techniques for treating a bifurcated body lumen. For example, a need further exists for additional stmt delivery systems that can be used with stems having a branch access side hole and/or an extendible branch portion.
 In another aspect, the catheter assembly includes a bifurcated stmt, which is disposed on the balloon. In particular, the present invention provides a catheter assembly including a bifurcated stmt, which has a main vessel portion and an extendible branch vessel portion. The branch vessel balloon is disposed substantially adjacent the extendible branch portion. Upon expansion, the branch vessel balloon expands the extendible branch vessel portion of the stmt into the branch vessel.
 According to another aspect, the present invention provides a catheter assembly, which includes a side sheath associated with the elongated catheter body.
At least a portion of the side sheath extends along the distal end of the catheter body and adjacent the branch vessel balloon. In some aspects of the invention, the branch vessel balloon is disposed on the side sheath. In another aspect of the invention, the side sheath is disposable in the branch vessel. Additionally, the main vessel balloon is disposable in the main vessel during placement of the catheter assembly in a bifurcated vessel. The accordion configuration can be oriented to expand in a direction substantially perpendicular to a longitudinal axis of the main vessel balloon.
In a further aspect of the invention, the branch vessel balloon is located on the side sheath and oriented to expand in a direction substantially parallel to a longitudinal axis of the side sheath.
 1n another aspect, the branch vessel balloon comprises a herniation on the main vessel balloon, and in another aspect, the present invention provides a catheter assembly which includes a side sheath. One end of the branch vessel balloon is slidably affixed to the side sheath.
 According to an additional aspect, the profile of the accordion folds of the catheter assembly of the present invention is substantially either round, elliptical, square, hexagonal or octagonal when viewed along the direction of inflation.
Additionally, in other aspects, the profile of the accordion folds is substantially triangular or round when viewed perpendicularly to the direction of inflation.
 According to yet another aspect, the present invention provides a catheter assembly for use in bifurcated vessels. The assembly includes an elongated catheter body having a proximal end and a distal end and a balloon associated with the distal end of the balloon catheter. The balloon includes a main vessel balloon for treating a main vessel of the bifurcation and a branch vessel balloon for treating a branch vessel of the bifurcation. The branch vessel balloon comprises a plurality of fluidly connected cells connected in series, the series defining an axis of primary inflation.
When the branch vessel balloon is expanded, expansion along the axis of primary inflation is greater than expansion in a radial direction, which is substantially perpendicular to the axis of primary inflation.
 A further aspect of the present invention provides a catheter assembly having successive cells, which differ in size from the preceding cells in the series.
In another aspect, the cells are adapted to merge into a substantially tubular structure when fully expanded.
positioning the assembly at the bifurcation; and inflating the balloon to expand the stmt in the main vessel.
 A further aspect of the invention provides a method of treating a bifurcation of a body lumen in which the step of inflating includes expanding a portion of the stmt outwardly toward the branch vessel. Another aspect provides a method in which the accordion configuration expands the portion of the stmt outwardly toward the branch vessel. The body lumen described above can be a blood vessel.
 FIG. I is a side view of an illustrative embodiment of a stmt delivery system constructed in accordance with the present invention.
 FIG. 7 is an enlarged side view of an accordion balloon of the stmt delivery system of FIG. 1.
 FIG. 8 is a perspective view of a portion of a stmt delivery system constructed according to an alternative embodiment of the present invention.
 FIG. 9 is a side view of the stmt delivery system of FIG. 8 with a cut-away view of a stmt mounted thereon in an unexpanded condition.
 FIG. 10 is a side view of the stmt delivery system of FIG. 9 with a cut-away view of a stmt mounted thereon in an expanded condition.
 FIG. 11 is side view of a stmt delivery system according to another embodiment of the invention.
 FIG. 12 is a side view of the stmt delivery system of FIG. 11 with a partial cut-away view of a stmt mounted thereon in an expanded condition.
 FIG. 13 is a partial cut-away view of another embodiment of a stmt delivery system with a slidable accordion balloon partially expanded.
with the accordion balloon further expanded.
 FIG. 15 is a side view of a stmt delivery system according to another embodiment of the invention in an expanded condition.
 FIG 16 is side view of the stmt delivery system of FIG. 15 with a partial cut-away view of a stmt in an expanded condition.
 FIG.17 is a side view of the stmt delivery system of FIG. 15 with a partial cut-away view of a stmt in an unexpanded condition.
preferred stmt to be delivered is generally configured to at least partially cover a portion of a branch vessel as well as a main vessel. In general, a wide variety of stems and deployment methods may be used with the stmt delivery system embodiments of the present invention and the present invention should be understood to not be limited to any particular stmt design or configuration. Examples of the types of stems that may be used with the delivery systems of the present invention are disclosed, for example, in U.S. Patent No. 6,210,429 to Vardi et al., U.S. Patent No. 6,325,826 to Vardi et al., and U.S. Patent Publication No. US2004-0138737, entitled "Stmt With a Protruding Branch Portion For Bifurcated Vessels," and U.S. Publication No. US2004-0212940, entitled "Stmt With Protruding Branch Portion for Bifurcated Vessels," the entire contents of which are incorporated herein by reference. In general, the aforementioned stmt includes a branch portion located at some point along the length of the stmt that is configured to be extendible into a branch vessel in a vessel bifurcation. Once the stmt is in position in the main vessel and the branch portion is aligned with the side branch vessel the stmt can be expanded and the delivery system in accordance with the principles of t he invention is particularly adapted to expand the stmt branch portion into the side branch vessel. The stmt, including the branch portion, may be expanded with a single expansion or multiple expansions.
 The balloon catheter system and stmt delivery system and methods of use in accordance with the principles of the invention are directed to a type that treats bifurcations in the vasculature, for example, where a branch vessel extends from a main vessel. The system provides for the branch balloon to extend into the branch vessel and, preferably, deploy an extendible branch portion of a stmt into the branch vessel as disclosed in the patents and applications discussed above, for example.
Embodiments of the systems and methods are discussed more fully herein. In general, however, in accordance with the principles of the invention, balloon expansion into the branch vessel and, more particularly, to expand the branch stmt structure into the branch vessel, can be accomplished by way of an accordion balloon as described and illustrated herein. The accordion balloon is constructed to be expandable, predominantly axially, e.g., along its axis of primary inflation, allowing it to extend into the branch vessel and/or deploy the extendible branch structure of the above-described stent.
 In accordance with the principles of the invention, embodiments of the accordion balloon are shown and described herein. In certain embodiments, the accordion balloon can be associated or integral with the side sheath catheter.
Alternatively the accordion balloon can be associated or integral with the main balloon catheter as described in more detail in the following. Additionally, in certain embodiments (see, e.g., Figs. 11-17) the accordion balloon can be slidably attached to the catheter or sheath to accommodate the axial or longitudinal expansion of the accordion balloon.
 An illustrative view of one embodiment of a stmt delivery system 10 constructed in accordance with the present invention is shown in FIG. 1. Stent delivery system 10 generally comprises an elongate main catheter shaft 12 extending from a proximal end 14 to a distal end 16. As best seen in FIG. 2, distal end 16 has a bifurcated tip structure with two branch portions, a main vessel branch portion 18 and a side branch sheath 20 that branches off of main catheter shaft 12.
 Balloon 26 generally includes an inflatable portion 32 comprising an accordion balloon, as discussed in more detail in the following. Balloon 26 as shown can be a bifurcated balloon, which is attached to main vessel branch portion adjacent the distal end 16 and comprises first and second branch portions 27, 30. First branch portion 27 of balloon 26 comprises an elongate inflatable portion 28.
Second branch portion 30 of balloon 26 comprises the second inflatable portion or auxiliary inflatable portion 32 comprising the accordion balloon. Second branch portion includes an inflation lumen that branches off from first branch portion 27 proximally from the balloon 26 and extends substantially adjacent elongate inflatable portion 28.
The distal end of second branch portion 30 is attached to first branch portion 27 at a location distally from the balloon 26. In one preferred embodiment, the distal end of branch portion 30 is fixedly attached distally of balloon 26 in order to prevent at least the second inflatable portion 32 from moving around the first branch portion 27, although in alternate embodiments it may be removably attached.
 According to the present invention, the inflatable portions, or balloons, can be constructed of any suitable material. Preferably, they are made of non-compliant materials. The balloons may be constructed of an appropriate polymeric material.
Particular examples include the polyamide family, or the polyamide blend family, polyethylene (PE), polyethylene terephthalate (PET), polyurethanes, polyamides, and polyamide blends such as PBAX. The compliance of the first inflatable portion and the second inflatable portion 32 can be the same or different. In one preferred embodiment, second inflatable portion 32 is longitudinally positioned at a generally central location relative to the first inflatable portion 28. In alternate embodiments, second inflatable portion 32 may be positioned at any position adjacent first inflatable portion 28.
Inflation lumen 34 is also used to drain inflation fluid from first inflatable portion 28 and second inflatable portion 32 when it is desired to deflate the balloon. First and second inflatable portions are initially deflated when directing the stmt delivery device to the bifurcation lesion in a patient. In this embodiment, the inflation lumen 34 inflates inflatable portions 28, 32 substantially simultaneously. In an alternative embodiment, branch balloon portions 27 and 30 have separate inflation lumens. In this alternative embodiment inflatable portions 28 and 32 can be inflated simultaneously or sequentially. When sequential inflation is desired, preferably, the first inflatable portion 28 is inflated first, followed by the inflation of the second portion 32.
[0054) In the embodiment depicted in FIGS. 1-2, an optional side sheath 20 is illustrated which does not include an inflatable balloon. However, in alternate embodiments side sheath 20 could include an inflatable portion as discussed in more detail below and in co-pending U.S. Patent Application No. 10/644,550 entitled "Stmt With A Protruding Branch Portion for Bifurcated Vessels," for example.
Side sheath 20 can be exterior to and distinct from inflation lumen 34 and, if so, would not be in fluid communication with the interior of balloon 26 as shown. As shown in the embodiment of FIGS. 1-2, side sheath 20 preferably extends distally of balloon 26, and may include a proximal open end 37 at any point along the length of the stmt delivery system and a distal open end 39. Side sheath 20 can be of the type as described in U.S. Patent No. 6,325,826 to Vardi, et al., for example, and in operation the side sheath 20 can extend through a branch access hole of the stmt.
 Bifurcation 40 includes a main vessel 42 and a branch vessel 44.
Illustrative obstructions 46 located within bifurcation 40 may span or at least partially obstruct main vessel 42 and a proximal portion branch vessel 44. Generally, stmt delivery system 10 may be threaded over a first main guidewire placed in the main vessel to guide the delivery system to the treatment site. More specifically, the proximal end of first guidewire 36 is threaded into the distal open end of the main guidewire lumen 22 and the delivery system is tracked to a position at or near bifurcation 40, as depicted in FIG. 3. Second guidewire 38 (FIG. 5) is then threaded into stmt delivery system from the proximal end of the delivery system. More specifically, second guidewire 38 is threaded into the open proximal end 37 of side sheath 20, and may extend therefrom through the open distal end 39 of side sheath 20, as depicted in FIG.
 In one embodiment, the stmt delivery system 10 is positioned near bifurcation 40, and with the distal end 16 (FIG. 1) positioned near side branch vessel 44 (FIGS. 3-6), second guidewire 38 is advanced into side branch vessel 44 from side sheath 20.
 Once the system is properly positioned, pressurized fluid is supplied to first and second inflatable portions 28 and 32, respectively, of balloon 26 to dilate the body lumen and expand a stmt mounted thereon (FIG. 6). Preferably, the inflatable portion 28 expands the main body of the stem and inflatable portion 32 expands the side (opening) and expandable branch structure of the stmt, as discussed in more detail with reference to FIG. 6. After inflatable portions 28 and 32 have been inflated as described above, balloon 26 is deflated by draining the inflation fluid via inflation lumen 34. This allows the inflatable portions 28 and 32 to collapse in preparation for withdrawal of the assembly from vessel 42.
 Referring now to FIGS. 4 and 6, one preferred embodiment is shown with stmt delivery system 10 and an exemplary stmt 50 mounted on the exterior of distal end 16 of the stmt delivery system. Stent 50 includes an extendible branch portion 52 configured to extend into a branch vessel as discussed, for example, in U.S.
Patent No. 6,210,429 and in co-pending U.S. Application No. 10/644,550, entitled "Stmt with Protruding Branch Portion for Bifurcated Vessels". The second inflatable portion 32 may be configured and positioned to deploy the outwardly expanding stmt elements or branch portion 52 and may be positioned adjacent to the branch portion 52, or into a side branch access opening in the stmt. As shown in FIG. 6, when first and second inflatable portions 28 and 32 are expanded, they simultaneously or sequentially, depending upon the configuration of the inflation lumen, cause the stmt 50 to expand in the main vessel 42 and the branch portion 52 of stem 50 to be pushed or extended into the branch vessel 44. Upon inflation of the balloon 26, the second inflatable portion 32 expands and extends the branch portion 52 toward the branch vessel to open and support the entrance or ostium of the side branch artery.
This would occur simultaneously when the balloons share a common inflation lumen but could be sequentially if separate inflation lumens are used. Although a bifurcated balloon is depicted, as shown, more than two inflatable portions or more than two balloons may be utilized with the present invention, or a single balloon can be used herein as discussed with reference to Figs. 12-14.
 Further, although the second inflatable portion 32 of the embodiment illustrated in FIGS. 1-6 are shown as being centrally located on the second branch portion 30, it should be noted that the inflatable portion 32 may be located at any desired position along the length of the second branch portion 30. For example, once associated with a stem, it preferably can be placed such that it corresponds to the location along the middle 1/3 of the stmt, or, adjacent the extendible branch structure.
 Referring now to FIG. 7, the accordion feature will now be described in more detail with reference to an exemplary embodiment. FIG. 7 is an enlarged view of inflatable side portion 32 of bifurcated balloon 26 as depicted in FIGS. 1-6.
The inflatable side portion 32 is constructed to extend laterally outwardly from a longitudinal axis of the system and into the branch vessel. As shown, the inflatable side portion 32 has a generally "accordion" shape in that it includes a series of fluidly connected cells 60. The accordion cells 60 preferably have a broad central portion 64 which tapers to narrower end portions 62. Thus, when viewed in profile, the cells 60 typically have a "flattened" hexagon shape when inflated. However, the shape of the profile is not critical. For example, the profile of the cells 60 may have a more rounded shape. Further, the accordion structure 33 may be constructed so that upon maximum inflation, the individual cells 60 merge, resulting in a generally tubular structure. When deflated, the cells collapse into a low profile configuration as discussed in more detail in the following.
 The individual cells 60 are fluidly connected via the narrow end portions 62.
Thus, fluid entering the first cell 60 of the inflatable side portion 32 of the balloon 26 passes to successive cells 60 in the series of cells 60 comprising the inflatable side portion 32, creating an axis of primary inflation from the first cell 60 to the final cell 60. In this manner, the inflatable side portion 32 can expand to a greater extent along the axis of primary inflation than in the radial direction perpendicular to the axis of primary inflation. As such in the unexpanded condition, the balloon is substantially flat, e.g., a flat flexible disc shape, and in the expanded configuration the balloon length significantly increases along the axis of primary inflation. By comparison, for example, the main balloon 28 has a relatively fixed longitudinal length that remains substantially unchanged upon expansion.
 The components of the auxiliary inflatable side portion 32 may be sized appropriately, as will be readily apparent to those skilled in the art. The accordion structure 33 can be provided with a suitable inflated cell diameter and connector diameter. The diameters can vary according to various factors known to those skilled in the art. Further, the auxiliary inflatable side portion 32 can comprise any number of cells 35 as determined for the particular application. Additionally, the expansion of the second inflatable portion 32 produces a force and a configuration to deploy a branch portion 52 of a stmt 50 into a side branch vessel 44. Accordingly, second inflatable portion 32 may unfold or push out the branch portion 52 of the stent while controlling or limiting the radial expansion as desired.
 Branch vessel inflatable portion 32, as discussed above and as shown, includes an embodiment of the accordion feature and other embodiments are shown herein and discussed in the following. The accordion configuration of the inflatable portion 32, however, can include different shapes, sizes and construction in accordance with the principles of the invention. For example, the accordion feature can be combined with the embodiments disclosed in U.S. Provisional Patent Application Serial No.
60/S 18,870, entitled "Stmt Delivery Systems." Also, the accordion principles discussed above with reference to FIGS. 1-7 apply to the other embodiments discussed herein.
 FIG. 8 illustrates an alternative embodiment of the present invention also for use in the treatment of branch arteries, including alone or, for example, by incorporation into stmt delivery systems of the type previously described. The balloon depicted in the embodiment of FIG. 8 can be referred to as a "herniated"
accordion balloon configuration that functions in a manner similar to the embodiments described above. The herniated accordion balloon configuration is characterized by having a generally cylindrical shape in an unexpanded configuration, and a generally cylindrical shape with a generally accordion shaped appendage that inflates outwardly relative to the longitudinal axis of the balloon toward the branch artery in an expanded state or configuration. This protrusion can be referred to as a herniation, bulge, protrusion, or extension, for example. The particular shape, size, and configuration of the balloon and the accordion herniations illustrated herein are exemplary, and may be modified from that explicitly shown and described. The expandable herniation, bulge, protrusion, or extension can be expandable towards the entrance of side branch (see, e.g., 44, FIG.3) over a suitable dimension, such as 1-4mm.
 The embodiment of the balloon depicted in FIG. 8 can be utilized in a manner similar to that which has been described in connection with previously illustrated embodiments (see, e.g., FIGS. I-7). With regard to the embodiment depicted in FIG.
8, it should be understood that the herniated accordion balloon construction depicted herein can be used alone or can be substituted for the entire bifurcated balloon (e.g.
26, FIGS. 1-7) or a portion of the bifurcated balloon (e.g., 32) with certain modifications, as needed, in accordance with the principles of the invention.
 The particular configuration and dimensions of the balloon 527 can vary according to a number of factors. For purposes of illustration only, certain suitable, but non-limiting, dimensions of various components of the balloon 527 will now be described. The balloon 527 can be provided with a length dimension L~ which is about 4-100mm. The balloon can be provided with an outside diameter OD1 which is on the order of about 1-l Omm.
 Although the accordion herniation 532, of the embodiment illustrated in FIG.
8 are shown as being centrally located on the herniated balloon 527, it should be noted that the herniation 532 maybe located at any desired position along the length of the balloon. For example, once associated with a stmt, it can preferably be placed such that it corresponds to the location along the middle 1/3 of the stmt and/or adjacent the extendible branch structure of the stmt.
(0072] The balloon 527 can be constructed of any suitable material such as those previously disclosed herein. In addition, the balloon 527, as well as any other embodiments described herein, can be constructed of a composite material.
Suitable materials include a combination of elastomeric and semi to non-compliant materials such as: urethane; silicone; nylon; latex; (elastomeric) polyethylene hytrel pebax polyaryletherthketone; polyoxymethylene; polyamide; polyester thermoplastic polyetheretherkatone; and polypropylene (semi non-compliant). The balloon 526, can be also be constructed by combining the above-disclosed materials with woven textile materials such as Kevlar, silk, cotton, wool, etc. This can be accomplished by winding or weaving a textile material onto a rod that has the shape of the desired accordion herniated balloon. The polymer component of the composite is then extruded or dip-coated over the rod. This composite structure is then cured, heat set, or adhesively fused together. The rod is then removed and the remaining shape comprises the accordion herniated balloon 527. Alternatively, this can be accomplished by combining the above-described materials with woven material only on the main balloon portion and not on the accordion balloon portion, whereby upon application, by whatever process, the elastomeric or polyurethane, for example, alone forms the accordion balloon portion.
 FIG. 9 shows balloon 527 in a stmt delivery system 600, of which only the distal end portion is shown. System 600 is shown in an unexpanded condition.
The distal end is shown at 602 and the proximal end at 604. The system 600 generally includes balloon 526, side sheath 620 and bifurcated stmt 624, of the type discussed above. The stmt is depicted generally and without detail for illustration.
Side sheath 620 extends through a side branch access opening in stmt 624. In this figure, the unexpanded accordion herniation is shown at reference numeral 532. When unexpanded or collapsed, the accordion herniation 532 is a substantially flat configuration, for example, a flat flexible disc shape. As illustrated, the unexpanded accordion herniation 532 is disposed against the side of balloon 526, such as by folding. However, it is not necessary for the unexpanded accordion herniation 532 to be folded in this manner. For example, the unexpanded accordion herniation 532 may be folded entirely on top of balloon 527. In fact, any folding technique may be used as long as the herniation 532 is capable of being expanded and, in particular, expanded to deploy branch portion 626. FIG. 10 shows system 600 in an expanded condition with accordion herniation 532 expanded to deploy branch portion 626 of stmt 624 outwardly into a branch vessel (not shown).
 Referring now to FIGS. 11-12, an alternative embodiment of a stmt delivery system 1190 is shown. Stent delivery system 1190 comprises an elongate main catheter shaft 1192 extending from a proximal end 1194 to a distal end 1196.
Distal end 1196 can include a bifurcated structure with two branch portions, a main vessel branch portion 1198 and a side branch sheath 1100. Main vessel branch portion itself can include two branches, a first branch 1104 which can include a balloon 1102 and an accordion branch portion 1106. Balloon 1102 can include an elongate inflatable portion 1108 that extends along first branch portion 1104 of main vessel branch portion 1198.
 Accordion branch portion 1106 can extend between main vessel branch portion 1198 to about the distal end of side branch sheath 1100. Accordion branch portion 1106 can include a generally axially inflatable portion 1109, in particular, an accordion balloon. In general, inflatable portion 1109 is configured and designed such that upon inflation it expands or elongates along an axis, for example, its longitudinal axis 1111. In a preferred embodiment of the invention, the distal end of axially inflatable portion 1109 is slidably attached to side sheath 1100 while the proximal end can be secured to main vessel branch portion I 198. Portion 1109 can be slidably attached by any structure in accordance with the principles of the invention, including, for example, a flexible tube.
 In one method of slidable attachment, the distal end of axially inflatable portion 1109 may be fixedly attached to a tubular member 1110 that is slidably received on the exterior of side sheath 1100. In a preferred embodiment, axially inflatable portion 1109 is generally shaped and/or folded similar to an accordion and upon inflation, inflatable portion 1109 unfolds or expands in an axial direction, along its longitudinal axis 1111. In this manner, the distal tip of inflatable portionl 109 slides in the distal direction along side sheath 1100.
 In operation, when a stmt 2136 is mounted on the delivery system 1190 and delivered to a vessel bifurcation, outwardly deployable elements or branch portions 2138 ofthe stmt 2136 may be advantageously deployed by axially inflatable portion 1109 (FIG. 12). Inflatable portion 1109 is disposed within stmt 2136 in the unexpanded configuration and is expandable along its axis, e.g., its longitudinal axis, into the branch vessel. Because inflatable portion I 109 slides along side sheath 1100 in the distal direction, an axial force is created in the direction of side sheath 1100 that may more efficiently deploy a branch portion 2138 of a stmt 2136 into a side branch vessel. The axial force created may unfold or push out the branch portion 2138 of the stmt while controlling or limiting the radial expansion as desired. As a result, a stmt 2136 may be designed having a branch portion that can more effectively treat lesions in a side branch vessel. For example, in some stmt 2136 designs the extendible branch portion 2138 of the stmt 2136 may be extended further into the branch using this delivery system configuration.
 Referring to FIGS. 13, 14A and 14B, an alternative embodiment of an accordion or axially inflatable balloon 2120 is shown. Balloon 2120 extends coaxially along a catheter or sheath 2122. Sheath 2122 includes an inflation lumen 2130 for inflating balloon 2120 and a guidewire lumen 2132 for receiving a guidewire. Inflation lumen 2130 is in fluid communication with balloon 2120 through balloon intake 2134. Proximal end 2124 of balloon 2120 is fixedly attached to sheath 2122 and distal end 2126 of balloon 2120 is fixedly attached to a tubular member 2128, which is slidably received on the exterior of sheath 2122.
Tubular member 2128 can be a flexible tube. Tubular member 2128 preferably has a length sufficient to be attached to the balloon material and sufficient to extend into the balloon 2120 to form a fluid-tight seal when balloon 2120 is inflated. In particular, tubular member 2128 is constructed so that, upon inflation, it is slidable along sheath 2122, yet the end of sheath 2122 that is inside the balloon, when inflated, is pressed against sheath 2122 in an amount sufficient to create a fluid-tight seal. In operation, upon inflation, distal end 2126 is slidable along sheath 2122, by way of tubular member 2128 to expand balloon 2120 from x amount of expansion as shown in FIG.
13, further to y amount of expansion as shown in FIG. 14A, even further to z amount of expansion as shown in FIG. 14B where x < y < z. In an alternative embodiment, not shown, both proximal and distal ends 2124, 2126 could be fixedly secured to a sheath extending from the distal end and a sheath extending from the proximal end in accordance with the principles of the invention.
 The embodiment of FIGS. 13, 14A and 14B can be used alone or in combination with other embodiments disclosed herein. For example, sheath 2122 (FIGS. 13, 14A and 14B) may be part of a stmt delivery system. As shown in FIGS.
15-17, stmt delivery system 2300 can include a side sheath 2322, of the type described with reference to FIGS. 13, 14A and 14B, and main balloon catheter 2302.
Side sheath 2322 includes accordion balloon 2320 with tubular member 2328 as discussed above. FIG. 16 shows a stmt 2324 mounted on system 2300 in an expanded condition, while FIG. 17 shows a stmt 2324 mounted on system 2300 in an unexpanded condition. When stmt 2324 having a branch portion 2326 is mounted on the delivery system and delivered to a vessel bifurcation, sheath 2322 may extend through a side branch access hole of the stmt 2324 with balloon 2320 positioned adjacent an interior of the branch portion. As in the embodiment illustrated in FIGS.
13, 14A and 14B, the accordion balloon 2320 may be folded in any manner that allows for deployment of the branch portion 2326 of stmt 2324. Upon inflation, balloon 2320 expands axially by tubular member 2328 sliding distally along sheath 2322 in the distal direction creating an axial force along the axis of the side sheath.
The axial force created can expand or push out the branch portion 2326 of the stmt 2324 into the branch vessel a sufficient distance into the branch vessel and without unnecessarily expanding the branch portion 2326 radially. As a result, a stem has a branch portion 2326 that can more effectively be used to treat lesions in a side branch vessel. For example, in some stmt designs the extendible branch portion of the stmt 2324 may be extended further into the branch using this delivery system configuration.
 Although the invention has been described for use with a single accordion balloon, the use of one or more accordion balloons is contemplated as discussed, for example, in co-pending U.S. Patent Application Serial Number 10/834,066, entitled "Catheter Balloon Systems and Methods."
 In an alternative embodiment, shown in FIG. 18, a first guidewire lumen may not pass through the interior of first inflatable portion 3148. For example, the lumen may be affixed to the exterior of the balloon, or the balloon may be formed with a plurality of folds through which the guidewire passes. Or the guidewire (not shown) may pass through the folds of the balloon. In this embodiment, guidewire lumen 3142 is separate from the inflation lumen 3154. In a preferred embodiment, guidewire lumen 3142 may have an abbreviated or shorter length as compared to the inflation lumen 3154 thereby providing less lumen for a guidewire to pass through.
The distal end of lumens 3142 and 3154 are preferably attached together at the very distal tip of the delivery system, such as by bonding, and the proximal end of the guidewire lumen is connected to the inflation lumen. Thus, this stmt delivery embodiment is neither an "over the wire" system (the guidewire lumen does not stay inside the inflation lumen through the entire length of the delivery system).
Nonetheless, the abbreviated or shorter length of guidewire lumen 3142 as compared to the inflation lumen 3154 allows, for example, rapid insertion and removal of a guidewire therethrough. This feature can be used on a delivery system regardless of the number of the balloons used, or whether the delivery system utilizes a side sheath.
For example, this could be used alone or in combination with other embodiments described herein.
an elongated catheter body having a proximal end and a distal end; and a balloon associated with the distal end of the catheter, the balloon including a main vessel balloon for treating a main vessel of the bifurcation, and a branch vessel balloon for treating a branch vessel of the bifurcation, wherein the branch vessel balloon includes an accordion configuration capable of being expanded from an unexpanded collapsed accordion configuration to an expanded configuration extending into the branch vessel.
and wherein when the branch vessel balloon is expanded, expansion along the axis of primary inflation is greater than expansion in a radial direction, which is substantially perpendicular to the axis of primary inflation.
positioning the assembly at the bifurcation; and inflating the balloon to expand the stent in the main vessel.

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 Application No.
10
 Application No. 10
 Application No. 10