Patent Abstract:
Devices and methods for treating an aneurysm include a single unit having an access element and an occlusion element, the access element providing access to the aneurysm for introducing treatment objects such as coils therethrough while the occlusion element blocks the treatment objects from protruding into the vessel. The access element is an elongated element having an access lumen for direct introduction of coils or for introduction of coils via a microcatheter. The occlusion element is a balloon or an elongated element for introduction of blocking objects such as coils therethrough. In embodiments of the present invention, a distal end of the access element is preshaped at an angle to a longitudinal axis of the device, wherein upon introduction of the device into the vessel, the access element is aligned with the longitudinal axis and at placement of the device adjacent the aneurysm, the access element assumes its pre-shaped configuration.

Full Description:
CROSS-REFERENCES TO RELATED APPLICATIONS 
       [0001]    The present application is a divisional application of U.S. patent application Ser. No. 11/685,807, filed on Mar. 14, 2007, which claims the benefit of U.S. Provisional Application Ser. No. 60/781,727, filed on Mar. 14, 2006. 
     
    
     FIELD AND BACKGROUND OF THE INVENTION 
       [0002]    The present invention relates to devices and methods for treating intracranial aneurysms. Treatment of various types of intracranial aneurysms, such as wide-neck and vertebrobasilar aneurysms, has been particularly difficult. Current methods for endovascular treatment for such aneurysms include the introduction of coils into the aneurysm to fill or occlude the aneurysm. However, particularly in cases of wide-neck aneurysm, loops of coils may not be contained within the aneurysm and may protrude out into the vessel. A known technique to prevent escape of the coils is a two-catheter technique, in which a microcatheter and a balloon catheter are introduced simultaneously. For example, in one technique, the microcatheter is placed within the aneurysm, and, during coil delivery, a balloon is inflated in the parent vessel adjacent to the aneurysm orifice. The balloon remains inflated during coil delivery and until the configuration of coils is set, after which the balloon is deflated and the catheter is removed. In another technique, two microcatheters are placed in an aneurysm and multiple coils are introduced. 
         [0003]    The use of two devices is cumbersome and can result in wire entanglement, limited pushability and torqueability, increased procedure time and complications. 
         [0004]    An alternative method includes the use of self-expanding stents such as, for example, the Neuroform™ stents manufactured by Boston Scientific Corp. (MA, USA). Specifically, such stents are presented to the site of the aneurysm and deployed, and can help to prevent escape of coils. Self expanding stents are generally used due to their low profile and maneuverability, features which are crucial for small vessels associated with intracranial aneurysms. However, they are prone to positioning problems and are difficult to anchor in place during deployment. Furthermore, the use of stents in general is not always considered optimal, since once the stent is in place, it cannot be removed and may itself present additional problems such as turbulence, thrombosis, or even stenosis in the stented region of the vessel. Moreover, the presence of a stent warrants patient-prescribed anti-coagulation medication, which may be contraindicated for some patients. 
         [0005]    It would thus be advantageous to have a device which could be used to prevent escape of coils during a procedure which is devoid of the above limitations. 
       SUMMARY OF THE INVENTION 
       [0006]    According to one aspect of the invention, there is provided a device for providing a coil to an aneurysm. The device includes an access element having an access lumen and a distal end which is pre-shaped at an angle to a longitudinal axis of the device and which may be forcibly aligned with the longitudinal axis, and an occlusion element for occluding an ostium of the aneurysm during delivery of the coil, the occlusion element at least partially attached to the access element. 
         [0007]    According to another aspect of the invention, there is provided a method for treating an aneurysm. The method includes providing a device having an access element and an occlusion element, the access element having a distal end which includes a pre-shaped configuration which is at an angle to a longitudinal axis of the device, providing a guidewire through the access element and a distal connecting element positioned at a distal end of the occlusion element so as to straighten the pre-shaped distal end, introducing the device into a vessel adjacent to the aneurysm; releasing the guidewire from the distal connecting element so as to cause the access element to assume its pre-shaped configuration, occluding an ostium of the aneurysm the said occlusion element, and delivering a coil through the access element and into the aneurysm. 
         [0008]    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. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0009]    The above and further advantages of the present invention may be better understood by referring to the following description in conjunction with the accompanying drawings in which: 
           [0010]      FIGS. 1A and 1B  are schematic illustrations of a device in accordance with embodiments of the present invention, shown in a deployed state and a pre-deployed state, respectively; 
           [0011]      FIGS. 1C ,  1 D and  1 E are cross-sectional illustrations of the device of  FIGS. 1A and 1B , showing an access lumen, an inflation lumen and a core wire, in accordance with several configurations; 
           [0012]      FIGS. 1F and 1G  are illustrations of a distal portion of the device of  FIGS. 1A and 1B  in accordance with additional embodiments of the present invention; 
           [0013]      FIGS. 2A and 2B  are schematic illustrations of a device in accordance with further embodiments of the present invention, shown in a deployed state and a pre-deployed state, respectively; 
           [0014]      FIG. 2C  is a cross-section illustration of the device of  FIGS. 2A and 2B , showing an access lumen, an inflation lumen coaxial to the access lumen, and a core wire; 
           [0015]      FIGS. 3A and 3B  are schematic illustrations of a device in accordance with further embodiments of the present invention, shown in a deployed state and a pre-deployed state, respectively; 
           [0016]      FIG. 3C  is a cross-section illustration of the device of  FIGS. 3A and 3B , showing an access lumen, a shaft and a core wire; 
           [0017]      FIGS. 4A and 4B  are schematic illustrations of a device in accordance with further embodiments of the present invention, shown in a pre-deployed state and in a deployed state, respectively; 
           [0018]      FIGS. 5A-5D  are schematic illustrations of a device in accordance with yet further embodiments of the present invention, shown in deployed states in  FIGS. 5A and 5C  and in pre-deployed states in  FIGS. 5B and 5D ; 
           [0019]      FIGS. 6A-6D  are schematic illustrations of the steps of a method of using the devices of  FIGS. 1A-1G  or  FIGS. 2A-2C , in accordance with embodiments of the present invention; 
           [0020]      FIGS. 7A-7D  are schematic illustrations of the steps of a method of using the devices of  FIGS. 3A-3C , in accordance with embodiments of the present invention; 
           [0021]      FIGS. 8A-8D  are schematic illustrations of the steps of a method of using the devices of  FIGS. 5A-5D , in accordance with embodiments of the present invention; 
           [0022]      FIGS. 9A-9C  are schematic illustrations of the steps of a method of using the devices of the present application to treat an aneurysm at a Y-bifurcation; 
           [0023]      FIGS. 10A-10C  are schematic illustrations of the steps of a method of using the device of  FIGS. 4A and 4B  to treat an aneurysm at a Y-bifurcation; and 
           [0024]      FIGS. 11A-11C  are schematic illustrations of views of marker positions in accordance with several different positions of the devices of the present invention. 
       
    
    
       [0025]    It will be appreciated that for simplicity and clarity of illustration, elements shown in the drawings have not necessarily been drawn accurately or to scale. For example, the dimensions of some of the elements may be exaggerated relative to other elements for clarity or several physical components may be included in one functional block or element. Further, where considered appropriate, reference numerals may be repeated among the drawings to indicate corresponding or analogous elements. Moreover, some of the blocks depicted in the drawings may be combined into a single function. 
       DETAILED DESCRIPTION 
       [0026]    In the following detailed description, numerous specific details are set forth in order to provide a thorough understanding of the invention. It will be understood by those of ordinary skill in the art that the present invention may be practiced without these specific details. In other instances, well-known methods, procedures, components and structures may not have been described in detail so as not to obscure the present invention. 
         [0027]    Reference is now made to  FIGS. 1A and 1B , which are schematic illustrations of a device  100  in accordance with embodiments of the present invention, shown in a deployed state and in a pre-deployed state, respectively. Device  100  includes a shaft  103  having a proximal end  102  and a distal portion  104 . Shaft  103  is comprised of an access element  106  for accessing an area of an aneurysm, and an occlusion element  110 , for providing occlusion means to the ostium of the aneurysm. Distal portion  104  of shaft  103  includes an access element distal portion  107  and an occlusion element distal portion  140 , wherein occlusion element distal portion  140  includes a balloon  116  having a balloon proximal end  142  and a balloon distal end  144 . In the embodiment shown in  FIGS. 1A and 1B , access element  106  is an elongated element extending from proximal end  102  of shaft  103  to distal portion  104  of shaft  103 , and includes an access lumen  108  therethrough. Proximal end  102  of shaft  103  includes an access hub  117  for introduction of a material or object through access lumen  108 . Distal portion  107  of access element  106  extends distally past balloon proximal end  142 , and is comprised of a soft elastomeric or polymeric material such as a urethane, silicone rubber, latex, nylon, any copolymers thereof, or any other suitable material. Alternatively, distal portion  107  of access element  106  includes a spring-element that provides pre-shaping. A radiopaque access marker  125  is positioned on distal portion  107  of access element  106 . Occlusion element  110  is also an elongated element positioned alongside access element  106  and extending from proximal end  102  of shaft  103  to distal portion  104  of shaft  103 . Occlusion element  110  has a balloon  116  at a distal end thereof. Balloon  116  is shown in an inflated state in  FIG. 1A  and in a deflated state in  FIG. 1B . An inflation lumen  112  provides fluid communication between an inflation port  115  at proximal end  102  of shaft  103  and balloon  116 . Additional radiopaque markers  124  are positioned along occlusion element  110  and/or shaft  103 . 
         [0028]    A distal connecting element  114  is positioned at the distal end of device  100 , and may be attached to balloon  116 . Alternatively, distal connecting element  114  may be attached to a distal tip  119 , distal to balloon  116 , as shown in  FIGS. 1F and 1G , in the inflated and deflated states, respectively. In this embodiment, a radiopaque marker  124  may be positioned on distal connecting element  114 . As shown in  FIG. 1A , distal portion  107  of access element  106  is pre-shaped at an angle to a longitudinal axis  146  of device  100 , wherein longitudinal axis  146  is defined by an imaginary line connecting distal portion  104  and proximal end  102  of shaft  103 . The angle can be in a range of 0 to 90 degrees, and in most cases is in a range of 20-70 degrees. 
         [0029]    As shown in  FIG. 1B , pre-shaped access element  106  can be forcibly aligned with longitudinal axis  146  of device  100  by placing a guidewire  118  therethrough and further positioning guidewire  118  through distal connecting element  114 . This relatively straight configuration results in a reduced profile which is suitable for introduction and advancement through blood vessels. In one embodiment, access element  106  acts as a microcatheter for providing treatment coils. In an alternative embodiment, access element  106  acts as a conduit for a separate microcatheter placed therein. 
         [0030]    Reference is now made to  FIG. 1C , which is a cross-section illustration of section A-A, showing access lumen  108  and inflation lumen  112 . Inflation lumen  112  may be smaller than access lumen  108 , and may assume various shapes and configurations, provided that there is sufficient area for introduction of an inflation fluid. The cross-sectional shape of shaft  103  may be approximately circular, as shown in  FIG. 1C , elliptical, as shown in  FIG. 1D , may assume a figure-eight configuration, as shown in  FIG. 1E , or may be any other suitable shape or configuration. In some embodiments, a core wire  122  is positioned through device  100  to provide stiffness and enhance pushability and trackability. Additionally, stiffness of proximal end  102  of shaft  103  may be provided by braiding or by other methods known in the art. Stiffness improves overall pushability and torqueability. 
         [0031]    Reference is now made to  FIGS. 2A and 2B , which are schematic illustrations of a device  200  in accordance with alternative embodiments of the present invention, shown in a deployed state and in a pre-deployed state, respectively. Device  200  includes a shaft  203  having a proximal end  202  and a distal end  204 . Device  200  includes an access element  206  for accessing an area of an aneurysm, and an occlusion element  210 , for providing occlusion means to the ostium of the aneurysm. Distal end  204  of shaft  203  includes an access element distal portion  207  and an occlusion element distal portion  240 , wherein occlusion element distal portion  240  includes a balloon  216  having a balloon proximal end  242  and a balloon distal end  244 . In the embodiment shown in  FIGS. 2A and 2B , access element  206  is an elongated element extending from proximal end  202  of shaft  203  to distal end  204  of shaft  203 , and includes an access lumen  208  therethrough. Proximal end  202  of shaft  203  includes an access hub  217  for introduction of a material or object through access lumen  208 . Distal portion  207  of access element  206  extends distally past balloon proximal end  242  and is comprised of an elastomeric or polymeric material such as a urethane, silicone rubber, latex, nylon, any copolymers thereof, or any other suitable material. Alternatively, distal portion  207  of access element  206  includes a spring-element that provides pre-shaping. A radiopaque access marker  225  is positioned on distal portion  207  of access element  206 . Occlusion element  210  is also an elongated element positioned coaxial to access element  206  and extending from proximal end  202  of shaft  203  to distal end  204  of shaft  203 . Occlusion element  210  has a balloon  216  at a distal end thereof. Balloon  216  is shown in an inflated state in  FIG. 2A  and in a deflated state in  FIG. 2B . An inflation lumen  212  provides fluid communication between an inflation port  215  at proximal end  202  of shaft  203  and balloon  216 . Distal portion  207  of access element  206  protrudes through a portion of balloon  216 . Additional radiopaque markers  224  are positioned along occlusion element  210  and/or shaft  203 . 
         [0032]    A distal connecting element  214  is positioned at a distal end of device  200 , and may be attached to balloon  216 . Alternatively, distal connecting element  214  may be attached to a distal tip, distal to balloon  216 . As shown in  FIG. 2A , distal portion  207  of access element  206  is pre-shaped at an angle to a longitudinal axis  246  of device  200 , wherein longitudinal axis  246  is defined by an imaginary line connecting distal end  204  and proximal end  202  of shaft  203 . The angle can be in a range of 0 to 90 degrees, and in most cases is in a range of 20-70 degrees. 
         [0033]    As shown in  FIG. 2B , pre-shaped access element  206  can be forcibly aligned with longitudinal axis  246  of device  200  by placing a guidewire  218  therethrough and further positioning guidewire  218  through distal connecting element  214 . This relatively straight configuration results in a reduced profile which is suitable for introduction and advancement through blood vessels. In one embodiment, access element  206  acts as a microcatheter for providing treatment coils. In an alternative embodiment, access element  206  acts as a conduit for a separate microcatheter placed therein. 
         [0034]    Reference is now made to  FIG. 2C , which is a cross-section illustration of section B-B, showing access lumen  208  and inflation lumen  212  in a position which is coaxial to access lumen  208 . The cross-sectional shape of shaft  203  may be approximately circular, as shown in  FIG. 2C , or may be elliptical, may assume a figure-eight configuration, or may be any other suitable shape or configuration. In some embodiments, a core wire  222  is positioned through device  200  and alongside access element  206  to provide stiffness. Additionally, stiffness of proximal end  202  of shaft  203  may be provided by braiding or by other methods known in the art. Stiffness improves overall pushability and torqueability. 
         [0035]    Reference is now made to  FIGS. 3A and 3B , which are schematic illustrations of a device  300  in accordance with embodiments of the present invention, shown in a deployed state and in a pre-deployed state, respectively. Device  300  includes a shaft  303  having a proximal end  302  and a distal end  304 . Device  300  includes an access element  306  for accessing an area of an aneurysm, and an occlusion element  310 , for providing occlusion means to the ostium of the aneurysm. Distal end  304  of device  300  includes an access element distal portion  307  and an occlusion element distal portion  340 , wherein occlusion element distal portion  340  includes a balloon  316  having a balloon proximal end  342  and a balloon distal end  344 . In the embodiment shown in  FIGS. 3A and 3B , access element  306  is an elongated element extending distally past balloon proximal end  342 , and includes an access lumen  308  therethrough. Access element  306  is comprised of an elastomeric or polymeric material such as a urethane, silicone rubber, latex, nylon, any copolymers thereof, or any other suitable material. Alternatively, distal portion  207  of access element  206  includes a spring-element that provides pre-shaping. A radiopaque access marker  325  is positioned on distal portion  307  of access element  306 . Proximal end  302  of shaft  303  has a larger diameter than distal portion  304  of shaft  303  and than access element  306 . Occlusion element  310  is a balloon  316  positioned at distal end  304  of shaft  303 . Both access lumen  308  and balloon  316  are in communication with shaft  303 , and may be accessed via a shared hub  317 . Balloon  316  is shown in an inflated state in  FIG. 3A  and in a deflated state in  FIG. 3B . In one embodiment, a divider  309  partially separates balloon  316  from shaft  303 , allowing fluid flow but not allowing transfer of denser materials. This configuration allows for a microcatheter having an outer diameter which is approximately equal to an inner diameter of access element  306  to be introduced through access lumen  308 , effectively sealing access element  306 . Once the microcatheter is in place in the aneurysm, inflation fluid can be introduced through shaft  303 , and will flow directly into balloon  316 . Additional radiopaque markers  324  are positioned along occlusion element  310  and/or shaft  303 . 
         [0036]    A distal connecting element  314  is positioned at a distal end of device  300 , and may be attached to balloon  316 . Alternatively, distal connecting element  314  may be attached to a distal tip, distal to balloon  316 . As shown in  FIG. 3A , access element  306  is pre-shaped at an angle to a longitudinal axis  346  of device  300 , wherein longitudinal axis  346  is defined by an imaginary line connecting distal end  304  and proximal end  302  of shaft  303 . The angle can be in a range of 0 to 90 degrees, and in most cases is in a range of 20-70 degrees. 
         [0037]    As shown in  FIG. 3B , pre-shaped access element  306  can be forcibly aligned with longitudinal axis  346  of device  300  by placing a guidewire  318  therethrough and further positioning guidewire  318  through distal connecting element  314 . This relatively straight configuration results in a reduced profile which is suitable for introduction and advancement through blood vessels. In one embodiment, access element  306  acts as a microcatheter for providing treatment coils. In an alternative embodiment, access element  306  acts as a conduit for a separate microcatheter placed therein. 
         [0038]    Reference is now made to  FIG. 3C , which is a cross-section illustration of section C-C showing access lumen  308  and shaft  303 . The cross-sectional shape of shaft  303  may be approximately circular, as shown in  FIG. 3C , or may be elliptical, may assume a figure-eight configuration, or may be any other suitable shape or configuration. In some embodiments, a core wire  322  is positioned through device  300  to provide stiffness. Additionally, stiffness of proximal end  302  of shaft  303  may be provided by braiding or by other methods known in the art. Stiffness improves overall pushability and torqueability. 
         [0039]    Reference is now made to  FIGS. 4A and 4B , which are schematic illustrations of a device  400  in accordance with embodiments of the present invention, shown in a pre-deployed state and in a deployed state, respectively. Device  400  includes a shaft  403  having a proximal end  402  and a distal end  404 . Device  400  includes an access element  406  for accessing an area of an aneurysm, and an occlusion element  410 , for providing occlusion means to the ostium of the aneurysm. In the embodiment shown in  FIGS. 4A and 4B , access element  406  is an elongated element extending from an access port  411  along a body of device  400  to distal end  404  of shaft  403 , and includes an access lumen  408  therethrough. A radiopaque access marker  425  is positioned on a distal portion of access element  406 . Occlusion element  410  is an elongated element extending from proximal end  402  of shaft  403  to a location proximal to distal end  404  of shaft  403 . Occlusion element  410  includes a balloon  416  having a distal portion  417  and a proximal portion  418 . Distal portion  417  has a different compliance than proximal portion  418 . The difference in compliance may be provided by the use of different materials for distal portion  417  and proximal portion  418 . Alternatively, the same material may be used, but with different durometers or thicknesses. Any other known method of providing an object with two different compliances may be used. In a preferred embodiment, distal portion  417  has a lower compliance than proximal portion  418 . In other embodiments, distal portion  417  has a higher compliance than proximal portion  418 . Balloon  416  is shown in a deflated state in  FIG. 4A  and in an inflated state in  FIG. 4B . An inflation lumen  412  provides fluid communication between an inflation port  415  at proximal end  402  of shaft  403  and balloon  416 . 
         [0040]    While generally not recommended for endovascular aneurysm treatment, there may be some cases where the use of a stent may be beneficial. It should be readily apparent that a stent may be positioned at a distal end of any of the devices described above, and that balloon  116 ,  216  or  316  may be used to deploy the stent. 
         [0041]    In some embodiments, a fixed wire is added to the distal end of balloon  116 ,  216 ,  316  or to a distal tip of the device. This wire can aid in rotation of the device and can enhance torqueability. 
         [0042]    Reference is now made to  FIGS. 5A ,  5 B,  5 C and  5 D, which are schematic illustrations of a device  500  in accordance with embodiments of the present invention. In a first embodiment, shown in  FIG. 5A  in a deployed state and in  FIG. 5B  in a pre-deployed state, device  500  includes a shaft  503  having a proximal end  502  and a distal portion  504 . Device  500  includes an access element  506  for accessing an area of an aneurysm, and an occlusion element  510 , for providing occlusion means to the aneurysm. Access element  506  is an elongated element extending from proximal end  502  of shaft  503  to distal portion  504  of shaft  503 , and includes an access lumen  508  therethrough. A distal portion  507  of access element  506  is comprised of a soft elastomeric or polymeric material such as a urethane, silicone rubber, latex, nylon, any copolymers thereof, or any other suitable material. Alternatively, distal portion  507  of access element  506  includes a spring-element that provides pre-shaping. 
         [0043]    A radiopaque access marker  525  is positioned on distal portion  507  of access element  506 . Occlusion element  510  is also an elongated element positioned alongside and attached to access element  506 , and extending from proximal end  502  of shaft  503  to distal portion  504  of shaft  503 . Occlusion element  510  includes an occlusion lumen  512  for introduction of occlusion material, such as a coil, therethrough. A distal portion  513  of occlusion element  510  is comprised of a soft elastomeric or polymeric material such as a urethane, silicone rubber, latex, nylon, any copolymers thereof, or any other suitable material. Alternatively, distal portion  513  of occlusion element  510  includes a spring-element that provides pre-shaping. Additional radiopaque markers  524  may be positioned along occlusion element  510 . In one embodiment, shaft  503  is a dual lumen shaft having an access lumen  508  and an occlusion lumen  512 . 
         [0044]    Distal portions  507  and  513  are pre-shaped at an angle to a longitudinal axis of device  500 , wherein the longitudinal axis is defined by an imaginary line connecting distal portion  504  and proximal end  502  of shaft  503 . The angle can be in a range of 0 to 90 degrees, and in most cases is in a range of 20-70 degrees. Proximal end  502  of shaft  503  includes an access hub  517  for introduction of a material or object through access lumen  508 , and an occlusion hub  519  for introduction of a material or object through occlusion lumen  512 . 
         [0045]    Device  500  is shown in a pre-deployed position in  FIG. 5B , wherein a guidewire  518  positioned through occlusion lumen  512  forcibly aligns distal portions  507  and  513  with the longitudinal axis of device  500 . Alternatively, guidewire  518  may be positioned through access lumen  508 . This relatively straight configuration results in a reduced profile which is suitable for introduction and advancement through blood vessels. Upon removal of guidewire  518 , distal ends  507  and  513  assume their pre-shaped configuration. 
         [0046]    In an alternative embodiment, shown in  FIGS. 5C and 5D , a distal connecting element  514  is positioned at distal end of occlusion element  510 . In this embodiment, an additional radiopaque marker  524  may be positioned on distal connecting element  514 . In this embodiment, pre-shaped access element  506  and pre-shaped occlusion element  510  can be forcibly aligned with the longitudinal axis of device  500  by placing a guidewire  518  through access lumen  508  and further positioning guidewire  518  through distal connecting element  514 . 
         [0047]    Reference is now made to  FIGS. 6A-6D , which are schematic illustrations of the steps of a method of using device  100  to treat an aneurysm. Although the figures are shown and described with respect to device  100 , the method for using device  200  may be the same as for device  100 . As shown in  FIG. 6A , device  100  is introduced over a guidewire  118  into a main vessel  132  to an area of an aneurysm  134 . Device  100  is in its unexpanded state, with distal portion  107  of access element  106  held in an aligned position with device  100  via guidewire  118  placed through access element  106  and distal connecting element  114 . As shown in  FIG. 6B , guidewire  118  is retracted proximally, releasing guidewire  118  from distal connecting element  114 , and causing distal portion  107  of access element  106  to assume its pre-shaped configuration. Distal portion  107  of access element  106  is positioned within aneurysm  134 . Markers  124  and  125  are used for positioning, as will be described in further detail hereinbelow. As shown in  FIG. 6C , access element  106  is positioned within aneurysm  134 , and balloon  116  is expanded—blocking the neck or ostium of aneurysm  134 . As shown in  FIG. 6D , a coil  136  is then introduced through access lumen  108  and into aneurysm  134 , in accordance with methods known in the art. Alternatively, a microcatheter is then introduced through access lumen  108 , and coil  136  is delivered through the microcatheter. Balloon  116  can be inflated and deflated several times during the procedure so as to alternate between allowing normal blood passage through main vessel  132 , and keeping the ostium of aneurysm  134  blocked until coil  136  is set. Once coil  136  is set, balloon  116  is deflated, and device  100  is removed from the vessel. 
         [0048]    Reference is now made to  FIGS. 7A-7D , which are schematic illustrations of the steps of a method of using device  300  to treat an aneurysm. As shown in  FIG. 7A , device  300  is introduced over a guidewire  318  into a main vessel  132  to an area of an aneurysm  134 . Device  300  is in its unexpanded state, with access element  306  held in an aligned position with device  300  via guidewire  318  placed through access element  306  and distal connecting element  314 . As shown in  FIG. 7B , guidewire  318  is retracted proximally, releasing guidewire  318  from distal connecting element  314 , and causing distal portion  307  of access element  306  to assume its pre-shaped configuration. Distal portion  307  of access element  306  is positioned within aneurysm  134 . Markers are used for positioning, as will be described in further detail hereinbelow. As shown in  FIG. 7C , distal portion  307  of access element  306  is positioned within aneurysm  134 . Microcatheter  320  is then positioned in access lumen  308 . Microcatheter  320  effectively seals access element  306 , allowing for inflation fluid to reach balloon  316 . Balloon  316  is then expanded, blocking the neck or ostium of aneurysm  134 . As shown in  FIG. 7D , a coil  336  is then introduced through microcatheter  320  and into aneurysm  134 , in accordance with methods known in the art. Balloon  316  can be inflated and deflated several times during the procedure so as to alternate between allowing normal blood passage through main vessel  132 , and keeping the ostium of aneurysm  134  blocked until coil  336  is set. Once coil  336  is set, balloon  316  is deflated, and device  300  is removed from the vessel. 
         [0049]    Reference is now made to  FIGS. 8A-8D , which are schematic illustrations of the steps of a method of using device  500  to treat an aneurysm. Although the figures are shown and described with respect to one embodiment of device  500 , the method for using other embodiments of device  500  may be the same as the method depicted in  FIGS. 8A-8D . As shown in  FIG. 8A , device  500  is introduced over a guidewire  518  into a main vessel  132  to an area of an aneurysm  134 . Device  500  is in its undeployed state, with access element  506  and occlusion element  510  held in an aligned position via guidewire  518  placed through access element  506  and distal connecting element  514 . As shown in  FIG. 8B , guidewire  518  is retracted proximally, releasing guidewire  518  from distal connecting element  514 , and causing distal portion  507  of access element  506  and distal portion  513  of occlusion element  510  to assume their pre-shaped configurations. Distal portion  507  of access element  506  and distal portion  513  of occlusion element  510  are positioned within aneurysm  134 . Markers  524  and  525  are used for positioning, as will be described in further detail hereinbelow. As shown in  FIG. 8C , a blocking coil  535  is introduced through occlusion lumen  512  and into aneurysm  134 —blocking the neck or ostium of aneurysm  134 . As shown in  FIG. 8D , one or more coils  136  are then introduced through access lumen  508  and into aneurysm  134 , in accordance with methods known in the art. After coils  136  are delivered into aneurysm  134  and detached, and satisfactory filling of the aneurysm is confirmed, blocking coil  535  is detached. Detachment of coils  136  and blocking coil  535  is achieved in accordance with methods known in the art. Alternatively, a microcatheter is introduced through occlusion lumen  512  to deliver blocking coil  535 , and a microcatheter is introduced through access lumen  108  to deliver coils  136 . This method alleviates the long occlusion time or potential vessel damage sometimes associated with the use of balloons for occlusion. 
         [0050]    Reference is now made to  FIGS. 9A-9C , which are schematic illustrations of a method of using device  100  to treat an aneurysm at a Y-bifurcation, such as a vertebrobasilar junction. In this type of vessel, an aneurysm  234  may be positioned just opposite a main vessel  232 , and must be accessed head-on rather than from an angle. Although the method is shown for device  100 , it should be readily apparent that any of the devices in accordance with the various embodiments may be similarly used. As shown in  FIG. 9A , device  100  is introduced over a guidewire  118  through main vessel  232 . As shown in  FIG. 9B , access element  106  is positioned in aneurysm  134 . Balloon  116  is then inflated, as shown in  FIG. 9C . In some instances, balloon  116  is compliant enough to block the ostium on its own. In other instances, it may be useful to introduce a second device with balloon  116  positioned over the remainder of ostium  134 . Once the ostium is blocked, coil  136  is introduced into aneurysm  134 , as described above with respect to  FIGS. 6A-6D ,  7 A- 7 D and  8 A- 8 D. 
         [0051]    Reference is now made to  FIGS. 10A-10C , which are schematic illustrations of a method of using device  400  to treat an aneurysm at a Y-bifurcation, such as a vertebrobasilar junction. In this type of vessel, an aneurysm  234  may be positioned just opposite a main vessel  232 , and must be accessed head-on rather than from an angle. As shown in  FIG. 10A , device  400  is introduced over a guidewire  419  through main vessel  232 . As shown in  FIG. 10B , access element  406  is positioned in aneurysm  134 , and balloon  416  is inflated. The high compliance of proximal portion  418  causes proximal portion  417  to be inflated over a wide area, causing the ostium to be substantially blocked. The low compliance of distal portion  417  prevents balloon  416  from expanding into aneurysm  234 . Once the ostium is blocked, coil  136  is introduced into aneurysm  234 , as described above with respect to  FIGS. 6A-6D ,  7 A- 7 D,  8 A- 8 D, and  9 A- 9 D. 
         [0052]    Reference is now made to  FIGS. 11A ,  11 B and  11 C, which are illustrations of several views of marker positioning. Marker  125 , positioned on distal portion  107  of access element  106 , and markers  124 , positioned along the longitudinal axis of device  100 , together provide an indication of positioning and location. It should be readily apparent that similar configurations are provided in the alternative embodiments of device  200 ,  300 ,  400 , and  500 . In a first view, shown in  FIG. 11A , markers  124  form a relatively straight line, while marker  125  is slightly off the line formed by markers  124 . This indicates translational positioning of device  100  prior to deployment. When the distal portion  107  of access element  106  of device  100  is released, it assumes its pre-shaped configuration, and marker  125  moves to a position which is further off the line formed by markers  124 , as shown in  FIG. 11B . If positioning is inaccurate, marker  125  appears at a side opposite the aneurysm, as shown in  FIG. 11C . Thus, if a user views the view shown in  FIG. 11C  or a similar view, the user can then rotate device  100  until it is in the correct position as indicated by the position of markers  124  and  125  as shown in  FIG. 11B . This specific configuration of markers allows for proper alignment and positioning within the vessel. 
         [0053]    In additional embodiments of the invention, access element  106 ,  206 ,  306 ,  406  or  506  may include multiple access lumens. Moreover, points of attachment of access element  106 ,  206 ,  306  or  506  to occlusion element  110 ,  210 ,  310  or  510 , respectively, may vary. In one embodiment, the access element is attached at a midpoint of the balloon. In other embodiments, the access element is attached at a proximal end of the balloon, at a distal end of the balloon, or at any point in between. 
         [0054]    While certain features of the invention have been illustrated and described herein, many modifications, substitutions, changes, and equivalents may occur to those of ordinary skill in the art. It is, therefore, to be understood that the appended claims are intended to cover all such modifications and changes as fall within the true spirit of the invention.

Technology Classification (CPC): 0