Abstract:
A bifurcated balloon for in vivo use, comprises: a proximal hollow tubular element, two bifurcating hollow tubular elements extending distally from a distal end of the proximal hollow tubular element, each of the two elements comprising: a first distal tubular element guidable into a first branch of a vessel bifurcation, and a second distal tubular element guidable into a second branch of the vessel bifurcation. The bifurcated balloon further comprises a longitudinal chamber extending from a distal end of the first distal tubular element, and a first substantially longitudinal guidewire channel passing through the longitudinal chamber, the first guidewire channel having two ends of which a first end passes through a proximal portion of the longitudinal chamber.

Description:
FIELD AND BACKGROUND OF THE INVENTION 
       [0001]    The present invention relates to endovascular balloons used to recanalize, dilate and/or deploy a stent within a constricted vessel. 
         [0002]    Balloon angioplasty for opening a constricted segment of a blood vessel has become a widely accepted therapeutic alternative to coronary and peripheral arterial bypass surgery for many patients. 
         [0003]    To deliver a balloon catheter used in balloon angioplasty, a guidewire is advanced through the vasculature across the constricted vessel segment. A dedicated guidewire lumen in the balloon portion of the catheter is fed over the guidewire; the dedicated lumen substantially spanning the longitudinal length of the balloon interior. The balloon is advanced along the guidewire through the vasculature until reaching the constricted vessel segment. The balloon is inflated to apply radial outward pressure against the walls of the constricted vessel segment to restore vessel patency, and normal vessel diameter. 
         [0004]    When used to deploy a stent in the constricted vessel segment, the unexpanded stent is mounted around the unexpanded balloon and transported to the constricted vessel segment. Upon reaching the constricted vessel segment, the balloon and stent are expanded, thereby restoring patency and normal vessel diameter to the constricted vessel and providing a structure that will continue to support the vessel wall. 
         [0005]    The precise positioning of the balloon against the constricted vessel segment is critical to the success of the procedure; yet, many factors can adversely affect balloon deliverability and precise positioning. 
         [0006]    The human vascular tree is far from being uniform in structure and each procedure is a unique experience requiring considerable manual dexterity. With currently available balloon systems, certain lesions are inaccessible and/or exceedingly difficult to reach due to vessel narrowing and rigidity of the treated vessel and lesions. Hence, the unexpanded balloon should be designed with a narrow cross sectional diameter (crossing profile). 
         [0007]    Vascular balloon dilation is more challenging when the constricted vessel segment is located within a bifurcation in the vessel: where a sizable side branch vessel bifurcates off a main branch vessel. A common treatment technique consists of inflating two balloons sequentially; a first balloon in the main branch vessel followed by a second balloon in the side branch vessel. 
         [0008]    Unfortunately, sequential dilatations are frequently ineffective in treating bifurcated constricted vessels, as the vessel wall at the bifurcation tends to stretch outward; resulting in narrowing of the adjacent branch or shifting atherosclerotic debris from one vessel to the other, referred to as “shifting plaque”. 
         [0009]    In order to prevent adjacent branch narrowing, a “kissing balloon” technique has been developed, as described in U.S. Pat. No. 4,896,670 (Crittenden), the entirety of which is incorporated herein by reference. In the kissing balloon technique, a first balloon occupies the proximal main branch vessel (trunk) and a segment of the distal main branch vessel. A second balloon occupies a segment of the proximal main branch (trunk) and a segment of the side branch vessel. Prior to inflation, the proximal portions of the two balloons occupy the proximal main branch vessel sit side-by-side and, upon inflation, the first proximal balloon portion “kisses” the second proximal balloon portion. 
         [0010]    The “kissing balloon” technique is not without drawbacks, including: 
         [0011]    a) difficulty of coordinating inflation and deflation of two separate balloons using two separate inflators by two operators; 
         [0012]    b) creation of asymmetric and non-circular expansion of the proximal main branch (MB) where the “kissing” takes place, potentially causing suboptimal post-inflation results. For example, underexpansion will fail to properly clear the stenotic segments; while overexpansion can cause a dissection (tear) of the vessel wall. 
         [0013]    c) balloon slippage during inflation; 
         [0014]    d) difficulty in positioning the side-by-side balloon segments due to the large crossing profile created by the separate guidewires and guidewire lumens in each balloon; and 
         [0015]    e) difficulty in manipulating the guiding catheters as the catheters must accommodate two separate side-by-side balloons of at least 6 French (2.0 millimeters) or 7 French (2.3 millimeters). 
         [0016]    U.S. Pat. Nos. 4,413,989 (Schjeldahl et al) and 6,017,324 (Tu, et al), the entirety of which are incorporated herein by reference, disclose a “Y”-shaped balloon, herein bifurcated balloon. 
         [0017]    As seen in  FIG. 1   a , a prior art bifurcated balloon  180  has two guidewire lumens:
       a first guidewire lumen  136  passing through a proximal balloon trunk  130  and a first distal balloon branch  132 ; and   a second guidewire lumen  107  passing through proximal balloon trunk  130  and a second distal balloon branch  134 .       
 
         [0020]    The bifurcated balloon solves some of the problems posed by the kissing balloons. However, when guidewires  106  and  156  are fed through guidewire lumens  136  and  107  respectively, the large crossing profile hinders deliverability and accurate positioning of bifurcated balloon  180 . 
         [0021]    Additionally, two separate side-by-side guidewire lumens  106  and  156  increase the complexity and cost of manufacturing bifurcate balloon  180 . 
         [0022]    It would be highly advantageous to have a bifurcated balloon that deploys in bifurcated vessels without having at least some of the disadvantages of the prior art. 
       SUMMARY OF THE INVENTION 
       [0023]    The present invention successfully addresses at least some of the shortcomings of prior art by providing a bifurcated balloon wherein there is a maximum of one guidewire lumen passing through the bifurcated balloon; thereby substantially reducing balloon crossing profile, manufacturing complexity and production cost. 
         [0024]    According to the teachings of the present invention there is provided a bifurcated balloon having a proximal trunk and two distal bifurcating balloon arms, comprising a first distal balloon portion; and a second distal balloon portion. 
         [0025]    The bifurcated balloon includes a first guidewire lumen involving the proximal balloon trunk and a first distal balloon portion; and a second guidewire lumen that passes through a longitudinal extension tube which extends distally from a second distal balloon portion. First and second guidewires pass through the first and second guidewire lumens respectively. 
         [0026]    In embodiments, the second guidewire lumen passes into the extension tube via an end-hole at the distal end of the extension tube, and out through a side-hole in the proximal portion of the extension tube. 
         [0027]    When deployed with a stent having a single trunk and two distal bifurcating stent portions, the low bulk of the bifurcated balloon allows greater compaction of the stent in the unexpanded state, accruing precise balloon and stent placement and rapid deployment that ensures the patency of the bifurcated vessels. 
         [0028]    According to the teachings of the present invention there is also provided a method of manufacturing a rapid exchange bifurcated balloon, comprising: 
         [0029]    providing a bifurcating balloon having two distal balloon portions extending from a proximal balloon portion and a longitudinal distal tubular extension from a distal end of one of the two distal balloon portions. Additionally, the method includes making a side hole in a sidewall of the tubular extension, boring a distal hole in a distal end of the tubular extension; and connecting a guidewire lumen between the side hole and the distal hole. 
         [0030]    In embodiments, the method further includes, extending a second longitudinal tubular extension from a distal end of a second of the two distal balloon portions. In such cases, the method includes making a side hole in a sidewall of the second tubular extension, boring a distal hole in a distal end of the second tubular extension; and connecting a guidewire lumen between the side hole and the distal hole of the second tubular extension. 
         [0031]    According to one aspect of the present invention, there is provided a bifurcated balloon for in vivo use, comprising: a proximal hollow tubular element, two bifurcating hollow tubular elements extending distally from a distal end of the proximal hollow tubular element, each of the two elements comprising: a first distal tubular element guidable into a first branch of a vessel bifurcation, and a second distal tubular element guidable into a second branch of the vessel bifurcation. The bifurcated balloon further comprises a longitudinal chamber extending from a distal end of the first distal tubular element, and a first substantially longitudinal guidewire channel passing through the longitudinal chamber, the first guidewire channel having two ends of which a first end passes through a proximal portion of the longitudinal chamber. 
         [0032]    In embodiments, the second end of the first substantially longitudinal guidewire channel passes through a distal end of the longitudinal chamber. 
         [0033]    In embodiments, the second end of the first substantially longitudinal guidewire channel passes through a distal portion of the longitudinal chamber. 
         [0034]    In embodiments, the apparatus includes a first guidewire insertable through the substantially longitudinal guidewire channel. 
         [0035]    In embodiments, the apparatus includes a second substantially longitudinal guidewire channel passing through a proximal end of the proximal hollow tubular element and through a distal end of the second distal tubular element. 
         [0036]    In embodiments, the apparatus includes a second guidewire insertable through the second substantially longitudinal guidewire channel. 
         [0037]    In embodiments, the apparatus includes a second longitudinal chamber extending from a distal end of the second distal tubular element, and a second substantially longitudinal guidewire channel passing through the second longitudinal chamber, the second guidewire channel having two ends of which a first end passes through a proximal portion of the longitudinal chamber. 
         [0038]    In embodiments, the second substantially longitudinal guidewire channel passes through a distal end of the longitudinal chamber. 
         [0039]    In embodiments, the apparatus includes a second guidewire insertable through the second substantially longitudinal guidewire channel. 
         [0040]    In embodiments, the apparatus includes a catheter channel from a proximal end of the proximal hollow tubular element. 
         [0041]    According to another aspect of the invention, there is provided a method of manufacturing a rapid exchange bifurcated balloon, comprising: extending a longitudinal distal tubular extension from a distal end of a first of two distal balloon portions extending from a proximal portion of a bifurcated balloon, and creating a guidewire channel through the first longitudinal tubular extension. 
         [0042]    In embodiments, the method includes extending a second longitudinal tubular extension from a distal end of a second of the two distal balloon portions, and creating a guidewire channel through the second longitudinal tubular extension. 
         [0043]    According to still another aspect of the invention, there is provided a method of deploying a bifurcated balloon, comprising: providing a bifurcated balloon having a first guidewire channel through a proximal balloon portion and a first distal balloon portion and a second guidewire channel through a longitudinal tubular guidewire extension extending from a second distal balloon portion, passing a first guidewire through a proximal main branch vessel and a distal MB vessel and a second guidewire through the proximal MB vessel and a side branch vessel, feeding the first guidewire channel over the first guidewire, feeding the second guidewire channel over the second guidewire, moving the bifurcated balloon upward along the first and second guide wires, and visualizing the proximal and the first distal portion of the bifurcated balloon portion in the MB vessel and the second distal portion of the bifurcated balloon in the SB vessel. 
         [0044]    According to still another aspect of the invention, there is provided a bifurcated self-expandable stent and using a method of advancing and positioning the bifurcated self-expandable stent involving using either one or two longitudinal tubular extension tubes which may be positioned distal to the stent and which accommodate the guide wire on which the self expandable stent is advanced. 
         [0045]    In embodiments, the method includes inflating the bifurcated balloon, deflating the bifurcated balloon, and removing the bifurcated balloon from the SB vessel and the MB vessel. 
         [0046]    The present embodiments successfully address the shortcomings of the presently known configurations by providing a bifurcated balloon wherein there is a maximum of a single guidewire lumen passing through the bifurcated balloon; thereby substantially reducing balloon crossing profile, manufacturing complexity and production cost. 
         [0047]    Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, suitable methods and materials are described below. In case of conflict, the patent specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and not intended to be limiting. 
         [0048]    As used herein, the terms “comprising” and “including” or grammatical variants thereof are to be taken as specifying the stated features, integers, steps or components but do not preclude the addition of one or more additional features, integers, steps, components or groups thereof. This term encompasses the terms “consisting of” and “consisting essentially of”. 
         [0049]    The phrase “consisting essentially of” or grammatical variants thereof when used herein are to be taken as specifying the stated features, integers, steps or components but do not preclude the addition of one or more additional features, integers, steps, components or groups thereof but only if the additional features, integers, steps, components or groups thereof do not materially alter the basic and novel characteristics of the claimed composition, device or method. 
         [0050]    The term “method” refers to manners, means, techniques, and procedures for accomplishing a given task including, but not limited to, those manners, means, techniques, and procedures either known to, or readily developed from known manners, means, techniques, and procedures by practitioners of cardiology and cardiologic surgery. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0051]    The invention of a bifurcated balloon having, at any given cross section throughout the length of the bifurcated balloon, a maximum of one guidewire lumen, is herein described, by way of example only, with reference to the accompanying drawings. 
           [0052]    With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of the preferred embodiments of the present invention only, and are presented in the cause of providing what is believed to be the most useful and readily understood description of the principles and conceptual aspects of the invention. In this regard, no attempt is made to show structural details of the invention in more detail than is necessary for a fundamental understanding of the invention, the description taken with the drawings making apparent to those skilled in the art how the several forms of the invention may be embodied in practice. 
           [0053]    In the drawings: 
           [0054]      FIG. 1   a  shows a known bifurcated balloon configuration; 
           [0055]      FIG. 1   b  shows a bifurcated balloon in an expanded configuration, according to embodiments of the invention; 
           [0056]      FIG. 2  shows guidewires in a cross-section of a bifurcated vessel, according to embodiments of the invention; 
           [0057]      FIGS. 3-6  show deployment of the bifurcated balloon of  FIG. 1   b  in a cross-section of a bifurcated vessel, according to embodiments of the invention; 
           [0058]      FIG. 7  shows a bifurcated stent and bifurcated balloon assembly in an expanded configuration in a cross-section of a bifurcated vessel, according to embodiments of the invention; 
           [0059]      FIG. 8  shows the bifurcated stent of  FIG. 7  deployed in a cross-section of a bifurcated vessel, according to embodiments of the invention; and 
           [0060]      FIG. 9  shows an alternative embodiment of the bifurcated balloon shown in  FIG. 1   b , according to embodiments of the invention. 
       
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0061]    The present embodiments concern a bifurcated balloon having, at any given cross section throughout the length of the bifurcated balloon, a maximum of one guidewire lumen, thereby accruing a bifurcated balloon having a low bulk that is easily maneuvered through the vasculature. 
         [0062]    The principles and operation according to the present invention may be better understood with reference to the drawings and accompanying descriptions. 
         [0063]    Before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not limited in its application to the details of construction and the arrangement of the components set forth in the following description or illustrated in the drawings. The invention is capable of other embodiments or of being practiced or carried out in various ways. 
         [0064]    Also, it is to be understood that the phraseology and terminology employed herein is for the purpose of description and should not be regarded as limiting. 
         [0065]    Generally, the nomenclature used herein and the laboratory procedures utilized in the present invention include techniques from the fields of medicine, biology, chemistry, material sciences and engineering. Such techniques are thoroughly explained in the literature. 
         [0066]    Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention belongs. In addition, the descriptions, materials, methods, and examples are illustrative only and not intended to be limiting. Methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention. 
         [0067]    Referring now to the figures: 
         [0068]      FIG. 1   b  shows an embodiment of a bifurcated balloon  100  in an expanded form having a trunk, herein proximal main branch (MB) balloon portion  130  and two distal balloon portions extending distally therefrom: distal MB balloon portion  132  and side branch (SB) balloon portion  134 . As used herein with respect to balloon  100 , the term “proximal” refers to a portion of balloon  100  that is nearer to the operator; the term “distal” refers to a portion of balloon  100  that is farther away from the operator. 
         [0069]    Longitudinal MB guidewire lumen  136  extends from a proximal opening  108  catheter through proximal end of MB portion  130  and through a distal opening  135  through distal end of MB portion  132 . 
         [0070]    A guide wire  156  has been fed through guidewire lumen  136  into a catheter  111 . In embodiments, guidewire  156  exits a proximal end opening  117 , a configuration referred to as an “over the wire” system. In other embodiments, guide wire  156  exits out of a catheter side hole  113  proximal to bifurcated balloon  100 , a configuration referred to as a “rapid exchange” system. The proximal opening can be an end-opening ( 117 ) or a side opening ( 113 ) or may open at any segment of the balloon catheter shaft proximal to the balloon itself. 
         [0071]    Typically, catheter  111  connects to bifurcating balloon  100  with a halo tube (not shown) through which contrast material is introduced during inflation and withdrawn during deflation of bifurcated balloon  100 . 
         [0072]    In embodiments, an SB extension tube  112  extends distally from a distal end of SB balloon portion  134  and typically has a smaller diameter than SB balloon portion  134 . 
         [0073]    SB extension tube  112  includes an SB guidewire lumen  116  having a proximal side opening  118  passing through sidewall of SB extension tube  112  and a distal end opening  115  through the distal end of SB extension tube  112 . 
         [0074]    SB guidewire lumen  116  comprises a rapid exchange configuration that is significantly more distal and not traversing via the lumen of bifurcated balloon  100  as opposed to the case of lumen  107  of bifurcated balloon  180  ( FIG. 1   a ); and allows rapid loading of balloon  100 , via SB guidewire lumen  116  onto a guidewire  146  ( FIG. 1   b ). 
         [0075]    While opening  118  is shown approximately at about 1.5 centimeters distal to the distal end of SB balloon portion  134 , opening  118  could be located further proximally, closer to the distal end of SB balloon portion  134  or further distally, closer to distal end opening  115 . 
         [0076]    Alternatively, distal end opening  115  could be positioned proximally on the side of SB extension tube  112 , nearer to the distal end of SB balloon portion  134 . The many options for configuring openings  115  and  118 , providing easy mounting of SB guidewire housing on guidewire  146 , are well known to those familiar with the art. 
         [0077]    SB guidewire  146  passes externally to MB balloon portion  130  and SB balloon portion  134  so that only MB guidewire lumen  136  passes through bifurcated balloon  100 ; a configuration that greatly reduces the bulk of bifurcated balloon  100  both in the predeployed and expanded configurations as compared to bifurcated balloon  180  ( FIG. 1A ). 
         [0078]    Additionally, the inclusion of one guidewire channel  136  through bifurcated balloon  100  ( FIG. 1B ) reduces the complexity of bifurcated balloon  100 , and related manufacturing costs. 
         [0079]    Furthermore, as SB guidewire  146  passes externally to MB balloon portion  130 , distance  109  ( FIG. 1B ) between guidewires  156  and  146  is considerably greater than distance  109  ( FIG. 1   a ) associated with bifurcated stent  180 ; a distance that aids in preventing entanglement of guidewires  146  and  156  while maneuvering bifurcated balloon  100  through the vasculature in a predeployed state. 
         [0080]      FIG. 2  shows a constricted, herein stenotic, vessel  152  with stenotic plaques  126  located along MB proximal vessel segment  120 , MB distal vessel segment  122  and SB vessel segment  124 . 
         [0081]    As used herein, the term “distal” refers to a downstream position in vessel  152 , while the term “distally” refers to downstream movement in a distal direction  140 . 
         [0082]    Additionally, as used herein, the term proximal refers to an upstream position in vessel  152 , while the term proximally refers to an upstream movement in a proximal direction  142 . 
         [0083]    MB guidewire  156  has been fed distally in direction  140  to pass through MB proximal vessel segment  120  and an MB distal vessel segment  122 . SB guidewire  146  has been fed distally in direction  140  to pass through MB distal vessel segment  120  and SB vessel segment  124 . 
         [0084]    With MB guidewire  156  and SB guidewire  146  in place, as seen in  FIG. 3 , bifurcated balloon  100  is loaded on MB guidewire  156  and SB guidewire  146  so that SB guidewire  146  passes through SB guidewire lumen  116  and MB guidewire  156  passes through MB guidewire lumen  136 . 
         [0085]    Bifurcated balloon  100  is then advanced in distal direction  140  through MB vessel proximal segment  120  toward MB distal vessel segment  122  and SB vessel segment  124 , herein a targeted bifurcation  138 . 
         [0086]    Longitudinal SB extension tube  112  has a smaller cross-sectional area than SB proximal balloon portion  134 , aiding in ease of advancement, and positioning SB proximal balloon portion  134  in spite of narrowing that may be present in MB proximal vessel branch  120  prior to reaching targeted bifurcation  138 . 
         [0087]      FIG. 4  shows bifurcated balloon  100  in an unexpanded configuration, within targeted bifurcation  138 . 
         [0088]      FIG. 5  shows preparation of bifurcated balloon  100  for inflation. In deployment of bifurcated balloon, there are two options, either of which may be used by the operator. The most common scenario as seen in some embodiments, SB guidewire  146  is left in place until bifurcated balloon  100  has been inflated and deflated. Then the bifurcating balloon is withdrawn over wires both wire  146  and wire  156  which are maintained in segments  124  and  122  respectively. 
         [0089]    Alternatively, wire  146  is removed at any stage prior to withdrawing balloon  100  and balloon  100  is withdrawn over wire  156 . 
         [0090]      FIG. 6  shows stenotic tissue  126  being displaced outwardly in response to the inflation of bifurcated balloon  100 . Bifurcated balloon  100  can be inflated and deflated several times to ensure that stenotic tissue  126  assumes a substantially fixed radial outward position with respect to bifurcated vessel  152 . 
         [0091]    At the conclusion of the intervention, bifurcated balloon  100  is withdrawn proximally, in direction  142 , over guidewire  146  and guidewire  156 ; or (as noted above) over guidewire  156  alone. After vessel imaging demonstrates satisfactory results guidewire  146  and/or  156  are withdrawn proximally in direction  142 . 
         [0092]      FIG. 7  shows bifurcated stent balloon  190  adapted for transporting a stent  150  to targeted bifurcation  138 . 
         [0093]    Bifurcated stent  150  includes a proximal MB stent portion  160  aligned with proximal MB balloon portion  130 , a distal MB stent  162  aligned with distal MB balloon portion  132  and an SB stent  164  aligned with side branch (SB) balloon portion  134 . 
         [0094]    Bifurcated stent balloon  190  and stent  150  are introduced through MB proximal vessel segment  120  in the unexpanded configuration, similar to that shown in  FIGS. 3 through 5 . 
         [0095]    Prior to inflation of bifurcated balloon  190 , SB guidewire  146  is removed in proximal direction  142  and bifurcated balloon  190  has been inflated, thereby expanding stent  150  radially outward to compress and to clear vessel  152  of stenotic tissue  126 . 
         [0096]    Bifurcated stent balloon  190  typically minimally protrudes (overhangs) beyond the edges of stent  150 . 
         [0097]      FIG. 8  shows stent  150  in an expanded configuration at targeted bifurcation  138  while bifurcated stent balloon  190  and MB guidewire  156  are withdrawn in proximal direction  142  out of MB vessel  120  at the end of the procedure. 
         [0098]      FIG. 9  shows a bifurcating balloon  190  configured with a distal MB extension tube  182  having a guidewire lumen  186  that includes a proximal opening  181  and a distal opening  185  through which guidewire  156  is fed prior to deployment of stent  150 . 
         [0099]    Similar to SB extension tube  112  noted above, distal MB extension tube  182  has a smaller cross-sectional area than MB distal balloon portion  132  to aid in placement of stent  150 . Distal MB extension tube  182  in addition to SB extension tube  112  has potentially simplifies manufacture and design of bifurcating balloon  190 . 
         [0100]    Additionally, distal MB extension tube  182  reduces the profile of bifurcating balloon  190 , rendering this application desirable where proximal segment  120  and/or distal MB vessel branch segment  122  are significantly constricted. 
         [0101]    There is further provided a method of providing a bifurcated self-expanding stent and advancing and positioning the bifurcated self-expandable stent using either one or two longitudinal tubular extension tubes which may be positioned distal to the stent and which accommodate the guide wire on which the self expandable stent is advanced. 
         [0102]    The materials and dimensions that follow reference both  FIGS. 1 and 7 : In embodiments, bifurcated balloon  100  and bifurcated stent balloon  190  have a minimal inflation diameter of at least about 2.0 millimeter. In embodiments, bifurcated balloon  100  and bifurcated stent balloon  190  have a maximum inflation diameter of no more than about 40 millimeters applicable to all coronary and peripheral interventions at any vascular location. 
         [0103]    In embodiments, bifurcated balloon  100  and bifurcated stent balloon  190  have a wall thickness of at least about 0.01 millimeters. In embodiments, bifurcated balloon  100  and bifurcated stent balloon  190  have a wall thickness of no more than about 0.5 millimeters. However, thickness of material will depend on technology and minimal traits and characteristics as require by current industry standards for a given targeted bifurcation  138 . 
         [0104]    In embodiments of the present invention, distal MB balloon portion  132  and SB balloon portion  134  are optionally of substantially different dimensions, including length, expanded diameter, and/or unexpanded diameter. 
         [0105]    In other embodiments of the present invention distal MB balloon portion  132  and proximal MB balloon portion  130  are optionally substantially of different dimensions, including length, expanded diameter and/or unexpanded diameter. 
         [0106]    In further embodiments of the present invention distal SB balloon portion  134  and proximal MB balloon portion  130  are optionally substantially of different dimensions, including length, expanded diameter and/or unexpanded diameter. 
         [0107]    In embodiments, bifurcated balloon  100  and bifurcated stent balloon  190  have an unexpanded and expanded length between 12-150 mm, depending on the dimensions of targeted bifurcation  138 . 
         [0108]    In embodiments, bifurcated balloon  100  and bifurcated stent balloon  190  have an expanded diameter of 2-50 mm depending on the dimensions of targeted bifurcation  138 . 
         [0109]    In embodiments, bifurcated balloon  100  and bifurcated stent balloon  190  have a pre-deployed diameter of 0.2-8 mm, depending on the dimensions of targeted bifurcation  138 . 
         [0110]    In embodiments inflated and deployed bifurcated balloon  100 , bifurcated stent balloon  190  and stent  150  have an angle between their bifurcated portions ranging from 0-180 degrees depending on the angulation of targeted bifurcation  138 . 
         [0111]    In embodiments, bifurcated balloon  100 , bifurcated stent balloon  190  and stent  150  have an angle between their bifurcated portions of an angle of less than about 30°, in their pre-inflated and pre-deployed configuration. 
         [0112]    In embodiments, bifurcated balloon  100  and bifurcated stent balloon  190  comprise a material selected from the group consisting of: synthetic biostable polymer, a natural polymer, and an inorganic material. In embodiments, the biostable polymer comprises a material from the group consisting of: a polyethylene, a polyolefin, a polyurethane, a fluorinated polyolefin, a chlorinated polyolefin, a polyamide, an acrylate polymer, an acrylamide polymer, a vinyl polymer, a polyacetal, a polycarbonate, a polyether, an aromatic polyester, a polyether (ether keto), a polysulfone, a silicone rubber, a thermoset, and a polyester (ester imide). 
         [0113]    In embodiments, the natural polymer comprises a material from the group consisting of a polyolefin, a polyurethane, a Mylar, a silicone, a polyester and a fluorinated polyolefin. 
         [0114]    Although described with respect to treating bifurcated vessels of the cardiovascular system, and especially bifurcated arteries, the teachings of the present invention are generally applicable to many different cardiovascular and non-cardiovascular applications. Specific cardiovascular applications include, but not limited to, the deployment of bifurcated balloon  100 , bifurcated stent balloon  190 , bifurcated self expandable stent and bifurcated stent  150  in atherosclerotic, or other occlusive arterial and/or venous vascular disease, ectatic arteries and ectatic arteries containing an obstructive lesion, aneurismatic arteries, saphenous vein grafts and native arteries, coronary or any arterial perforation, coronary arterial fistula, aortic abdominal aneurysm and other aneurismatic peripheral arteries, transjugular intrahepatic portal shunt, percutaneous transluminal angioplasty, fistula closing and neuro interventions (such as aneurysms and arterial-venous malformations), small vessel intraluminal grafting, and ostial renal artery lesions. 
         [0115]    With respect to the teachings of the present inventions, cardiovascular vessels include, inter alia, coronary arteries, carotid arteries, renal arteries, iliofemoral popliteal and infra-popliteal arteries, aorta and aortic arch arteries, and mesenteric arteries. 
         [0116]    Additional non-cardiovascular applications include, intra alia, urological, gastroenterological, respiratory, venous and neurological applications. 
         [0117]    It is expected that during the life of this patent many relevant bifurcated balloon designs and materials will be developed and the scope of the term bifurcated balloon is intended to include all such new technologies a priori. 
         [0000]    As used herein the term “about” refers to ±10%. 
         [0118]    Additional objects, advantages, and novel features of the present invention will become apparent to one ordinarily skilled in the art upon examination of the following examples, which are not intended to be limiting. Additionally, each of the various embodiments and aspects of the present invention as delineated herein above and as claimed in the claims section below finds experimental support in the following examples. 
         [0119]    It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination. 
         [0120]    Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications, and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications, and variations that fall within the spirit and broad scope of the appended claims. All publications, patents, and patent applications mentioned in this specification are herein incorporated in their entirety by reference into the specification, to the same extent as if each individual publication, patent or patent application was specifically and individually indicated to be incorporated herein by reference. In addition, citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention.