Patent Abstract:
A method of filling an aneurysm space within the abdominal aorta is disclosed. The method involves placing a prosthesis in the abdominal aorta; delivering a fillable bladder in a deflated state into the aneurysm space using a catheter; placing a filler tube in fluid communication with an inflow port of the fillable bladder. The fillable bladder comprises a bladder seal surrounding the fillable bladder and the bladder seal has a first side, a second side, a third side, and a fourth side. The first side is symmetric with the second side with respect to a first axis of the fillable bladder and the third side is symmetric with the fourth side with respect to a second axis of the fillable bladder. The first axis is perpendicular to the second axis. The method further involves filling the fillable bladder with a filling agent and removing the filler tube.

Full Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application is a continuation of U.S. patent application Ser. No. 15/372,171 filed Dec. 7, 2016, which is a continuation of U.S. patent application Ser. No. 13/180,420 filed Jul. 11, 2011 (now U.S. Pat. No. 9,561,037), which is a continuation of U.S. patent application Ser. No. 10/622,437 filed Jul. 18, 2003 (now abandoned), each of which is herein incorporated by reference in its entirety. 
     
    
     BACKGROUND OF THE INVENTION 
     Field of the invention 
       [0002]    The present invention relates generally to a device for filling and/or stabilizing the void within an anatomical organ of the body, particularly within the vasculature, and methods for making and using the device. 
       Description of the Related Art 
       [0003]    An aneurysm is an abnormal dilatation of a biological vessel. Aneurysms can alter flow through the affected vessel and often decrease the strength of the vessel wall, thereby increasing the vessel&#39;s risk of rupturing at the point of dilation or weakening  FIG. 1  illustrates an abdominal aorta  2  with a sacular aneurysm  4  having an aneurysm wall  6 .  FIG. 2  illustrates the abdominal aorta  2  with a vascular prosthesis  8  implanted to treat the aneurysm  4 , a common aneurysm therapy. Vascular grafts and stent-grafts (e.g., ANEURX® Stem Graft System from Medtronic AVE, Inc., Santa Rosa, Calif.) are examples of vascular prostheses used to treat aneurysms by reconstructing the damaged vessel. 
         [0004]    With the prosthesis  8  implanted, an aneurysm sac  10  is defined by the volume between the prosthesis  8  and the aneurysm wall  6 . The sac  10  is often filled, partially or completely, with thrombi  12 . The thrombi  12  can be partially removed prior to deploying the prosthesis  8 . Whether the thrombi  12  are removed, gaps exist between the remaining thrombi  12  or the aneurysm wall  6  and the prosthesis  8 , and even when thrombus is present, it can be soft and non-structural. The prosthesis  8  can dislodge or migrate due to the poor fit caused by these gaps and shrinkage of the sac  10  that occurs after the implantation of the prosthesis  8 , either acutely due to sizing issues, or over time due to reformation of the sac  10 . To reduce the risk of prosthesis dislodgement and migration, the sac  10  can be filled to stabilize the anatomy adjacent to the prosthesis S resulting in better efficacy of the prosthetic treatment. 
         [0005]    A sac filler, or stabilizer, can be introduced to the sac  10  by trans-graft, trans-collateral, trans-sac, or endoluminal procedures. The trans-graft procedure introduces the sac filler through an opening in the prosthesis  8 , as shown by arrows  12 . The trans-collateral procedure, shown by arrows  16 , introduces the sac filler through a collateral vessel  18  under fluoroscopic guidance that is in direct communication with the sac  10 . The trans-sac procedure, often performed laparoscopically, introduces the sac filler through a puncture in the wall  6  of the aneurysm, as shown by arrows  20 . The endoluminal procedure introduces the sac filler through the vessel that has the aneurysm  4 , as shown by arrows  22 , but within the space between the prosthesis and the vessel wall. The trans-graft, trans-collateral and endoluminal procedures are often performed as minimally invasive, entirely endovascular procedures. 
         [0006]    It is desirable for a stabilizing element or sac filler to conform to the available space within the sac  10  by operation of the geometry of the device (e.g., by nesting or coiling) and/or by any coatings or materials utilized to promote fusing or other coagulative effect. 
         [0007]    U.S. Pat. No. 6,146,373 to Cragg et al. discloses a catheter system and method for injecting a liquid embolic composition and a solidification agent directly into a sac. Cragg et al. teach the use of organic solvents such as DMSO, ethanol and others injected directly in the aneurysm. Cragg et al. teach that these solvents can be toxic to tissue and may cause vascular spasms. Using liquid-solidifying agents in active vessels also carries a high risk that the agents will flow downstream creating emboli or flow into collateral vessels (e.g., lumbar arteries), which may lead to paralysis or other adverse events. 
         [0008]    U.S. Pat. No. 4,994,069 to Ritchart et al., U.S. Pat. No. 5,133,731 to Butler et al., U.S. Pat. No. 5,226,911 to Chee et al., and U.S. Pat. No. 5,312,415 to Palermo disclose examples of thrombogenic microcoils, common aneurysm treatments. The microcoil must be tightly packed into the aneurysm to minimize shifting of the microcoils. Shifting of the microcoil can lead to recanalization of the aneurysm. Another disadvantage of microcoils is that they are not easily retrievable. If a coil migrates out of the aneurysm, a second procedure to retrieve the coil and move the coil back into place, or replace the coil, might be necessary. 
         [0009]    U.S. Pat. Nos. 6,238,403 and 6,299,619, both to Greene, Jr. et al., disclose an embolic device with expansible elements and methods for embolizing a target vascular site with the device. The device taught by Greene Jr. includes a plurality of highly-expansible elements disposed at spaced intervals along a filamentous carrier. The expansion of the device after deployment reduces the volumetric precision with which the sac can be filled. If the volume of the expanded device is too large, the device can press against the inner side of weakened aneurysm wall and outer side of prosthesis, altering flow within the prosthesis and increasing the risk of rupture of the aneurysm. If the volume of the expanded device is too small, the prosthesis can still alter its position and dislodge or migrate. 
         [0010]    There is thus a need for a device and method that can precisely occlude a known sac volume with minimal displacement of the device over time. There is also a need for a device that can be deployed to the sac  10  while simultaneously minimizing toxicity, embolism risk, and other disadvantages previously associated with existing aneurysm sac fillers. 
       BRIEF SUMMARY OF THE INVENTION 
       [0011]    A vascular embolization device having a flexible leader connected to at least one non-expandable, space-occupying element is disclosed. The elements can be made, for example, from collagen and/or a polymer such as polypropylene. The device can also have a radiopaque agent fixed to or integrated with the device. Furthermore, the device can be coated or infused with a therapeutic and/or diagnostic agent. 
         [0012]    A vascular embolization device having a leader made from a flexible material and a space-occupying element connected to the leader is also disclosed. The element has a first component secured to a second component. The element can also be slidably connected to the leader, for example, by a ferrule. 
         [0013]    A vascular embolization device having one or more cylindrical space-occupying elements connected by flexible helical segments is disclosed. When fully extended, the element has a cross-sectional width to cross-sectional height ratio of equal to or greater than about 1.5:1. The cross-sectional width-to-height ratio can also be equal to or greater than 4:1. 
         [0014]    A vascular embolization device having a first space-occupying element having a first male interference-fit piece, and a second space-occupying element having a first female interference-fit piece is disclosed as well. The first male interference-fit piece and the first female interference-fit piece attach to impede removal of the first male interference-fit piece from the first female interference-fit piece. 
         [0015]    A vascular embolization device is also disclosed. The device has a first space-occupying element comprising a body and a first female interference-fit piece. The device also has a second space-occupying element comprising a body and a second female interference-fit piece. Furthermore, the device has a leader comprising a first male interference-fit piece on a first end and a second male interference-fit piece on a second end. The first male interference-fit piece attaches to the first female interference-fit piece and the second male interference-fit piece attaches to the second female interference-fit piece. 
         [0016]    A device volume for filling an abnormal void within the body including a binding agent is disclosed. The device volume is all or part of the volume of the device. The device has a first space-occupying piece, a second space-occupying piece and a binding agent. The first space-occupying piece is flexibly attached to the second space-occupying piece such as a continuous structure, such as a coil. The binding agent attaches the first space-occupying piece and the second space-occupying piece (e.g., each turn of the coil). The binding agent reduces the flexibility of the device volume and increases the pushability to aid in deployment. The flexibility of the device volume of the first space-occupying piece and the second space-occupying piece is restored when the binding agent is exposed to a softening agent. 
         [0017]    First and second pieces of the device can also have a flexible leader. The leader can connect to the first space-occupying piece at a first length along the leader. The leader can also connect to the second space-occupying piece at a second length along the leader. The leader can have a first end integrated with the first space-occupying piece and a second end integrated with the second space-occupying piece. The leader can have a first end attached to the first space-occupying piece to impede removal of the first space-occupying piece from the leader, for example, the leader can have a knot. The first and second space-occupying pieces can also either or both be non-expandable or expandable based on the desired clinical result. 
         [0018]    A space-occupying device having a flexible segment is disclosed. The segment is maintained in a substantially cylindrical configuration by a binding agent. The flexibility of the helical segment is increased when the binding agent is exposed to a softening agent. The flexible segment can have a helical segment. The flexible segment can also have a woven segment. 
         [0019]    A device for filling an abnormal void within the body is also disclosed. The device has a fillable bladder and a filling agent. The fillable bladder can be pressurized or otherwise occupied with the filling agent. The bladder can be porous. 
         [0020]    A method is disclosed for placing a space-occupying device or a plurality of space-occupying devices, such as the embolization devices disclosed herein, within a void. For example, a catheter having a distal exit is placed at a vascular site. A vascular embolization device is then passed through the catheter and the distal exit and deployed into the vascular site. The device has a flexible leader and at least one non-expandable, space-occupying elements connected to the leader. The method can include selecting a device or devices having the proper volume so that the device(s) is large enough to substantially fill the void, such as an aneurysmal sac within the vasculature, yet small enough to prevent substantial alteration of the natural fluid flow through an adjacent element, for example a vascular prosthesis implanted at or near the vascular site. Furthermore, the method of the present invention may provide for the removal of material within the void, such as the removal of thrombus from the aneurysmal sac and treatment with therapeutic agents prior to, or in conjunction with, the placement of the space-occupying elements. 
         [0021]    A method is also disclosed for filling an abnormal void within the body. The method includes placing a catheter having a distal exit in a void within the body. The method also includes passing a space-occupying device through the catheter and distal exit. The space-occupying device comprising a device volume and a binding agent. The binding agent reduces the flexibility of the space-occupying device. The distal exit of the device is placed at a treatment site at the time of deployment to aid in ejection of the space-occupying device from the delivery catheter. 
         [0022]    The flexibility of the space-occupying device can also increase when the binding agent is exposed to a softening agent. Deploying the device can include exposing the device to a softening agent. 
         [0023]    Another method is disclosed for filling an abnormal void within the body. The method includes deploying a device into the void. The device has a fillable volume. The method also includes filling the fillable volume with a filling agent. Filling the fillable volume can include using a filling agent such as a gel. Filling can include filling with a filling agent in the form of pieces or particulate. The pieces or particulate can be contained by the fillable volume. The pieces or particulate can have a smaller diameter than branch vessels and the pieces or particulate can be expandable. Filling can include filling with a filling agent in a flowable form. The method can also include hardening the filling agent. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0024]      FIG. 1 , not the invention, illustrates an aneurysm. 
           [0025]      FIG. 2 , not the invention, illustrates a vascular prosthesis implanted within an aneurysm and procedures for filling the aneurysm sac. 
           [0026]      FIG. 3 a    illustrates an embodiment of the embolization device. 
           [0027]      FIG. 3 b    illustrates a portion of the embolization device of  FIG. 3   a.    
           [0028]      FIG. 4  is a cross-sectional view of an embodiment of the leader and the space-occupying element. 
           [0029]      FIG. 5  illustrates an embodiment of the leader and the space-occupying element of  FIG. 4 . 
           [0030]      FIG. 6  illustrates an embodiment of the first section of the space-occupying element. 
           [0031]      FIG. 7  illustrates an embodiment of the space-occupying element of  FIG. 6 . 
           [0032]      FIG. 8  illustrates an embodiment of the first section of the space-occupying element. 
           [0033]      FIG. 9  illustrates an embodiment of the space-occupying element of  FIG. 8 . 
           [0034]      FIGS. 10 and 11  illustrate segments of embodiments of the embolization device. 
           [0035]      FIGS. 12 a - c    and  13  illustrate embodiments of the embolization device. 
           [0036]      FIG. 14  illustrates a segment of an embodiment of the embolization device. 
           [0037]      FIGS. 15, 16   a  and  16   b  illustrate segments of embodiments of the embolization device. 
           [0038]      FIG. 17  illustrates a partial cut-away view of an embodiment of the embolization device. 
           [0039]      FIGS. 18 and 19  illustrate embodiments of the embolization device. 
           [0040]      FIG. 20  illustrates an embodiment of the method of implanting the embolization device. 
           [0041]      FIG. 21  is a cut-away view of a catheter carrying an embodiment of the embolization device. 
           [0042]      FIG. 22  illustrates an embodiment of the method of implanting the embolization device. 
           [0043]      FIGS. 23 and 24  illustrate embodiments for the drivers used to deploy the embolization device. 
           [0044]      FIG. 25  illustrates an embodiment of the slider from the driver. 
           [0045]      FIG. 26  illustrates an embodiment of the connector. 
           [0046]      FIG. 27  illustrates an embodiment of the connector in an unlocked configuration. 
           [0047]      FIG. 28  is a cross-sectional view of the connector of  FIG. 27 . 
           [0048]      FIG. 29  illustrates the connector of  FIG. 27  in a locked configuration. 
           [0049]      FIG. 30  is a cross-sectional view of the connector of  FIG. 29 . 
       
    
    
     DETAILED DESCRIPTION 
       [0050]      FIG. 3 a    illustrates an embodiment of a vascular embolization or occlusion device  24  having a flexible leader  26  that can be connected to a first non-expandable space-occupying element  28  and a second non-expandable space-occupying element  30 . Additional non-expandable space-occupying elements  32  can also be connected to the leader  26  and provided in various lengths, depending on the typical volume of the sac  10  to be filled. The leader  26  can pass through the elements  28 ,  30  and  32 . The leader  26  can be fixed to the elements  28 ,  30  and  32 , or the elements  28 ,  30  and  32  can slide freely over the leader  26 . As illustrated in  FIG. 3   b,  the leader  26 , even if secured within an element  28 ,  30 , or  32 , can flex and bend within each element  28 ,  30  or  32 , or between the elements  28 ,  30  and  32 . 
         [0051]    The leader  26  can be a suture, preformed resilient structure, poppet, wire, fiber, monofilament, rail, or a woven thread or other combination thereof. The leader  26  can be completely separate and discrete from the elements  28 ,  30  and  32 . The leader  26  can be made from polymer, for example polyester (e.g., DACRON® from E. I. du Pont de Nemours and Company, Wilmington, Del.), polypropylene, polytetrafluoroethylene (PTFE), expanded PTFE (ePTFE), nylon, casted and/or dehydrated (lyphilize-free dry) collagen, silicone, spunbound, non-woven, non-bioabsorbable polyester (e.g., REEMAY® from Reemay, Inc., Old Hickory, Tenn.) and combinations thereof. The leader  26  can have a leader diameter  34  from about 0.050 mm (0.0020 in.) to about 1.3 mm (0.050 in.), more narrowly from about 0.2 mm (0.006 in) to about 0.25 mm (0.010 in.). A leader span  36  between the elements  28  and  30  can be from about 0 to about 2 times an element outer diameter  38 . more narrowly from about 0.5 to about 1 time the element outer diameter  38 . A total device length  40  from one end of the device  24  to the other can be ally length desired, for example about 30 cm (1 ft.). 
         [0052]    The elements  28 ,  30  and  32  can be spherical, cylindrical, or an approximation thereof The elements  28 ,  30  and  32  can be made from any of the materials disclosed above for the leader  26  as well as collagen, glass, polylactic acid (PLA), poly(lactic-co-glycolic acid) (PLEA), polyglycolic acid (PGA), other bioabsorbable material, polyurethane, polyethylene, or metal, for example stainless steel, titanium or nitinol. The element outer diameter  38  can be more than about 0.1 mm (0.005 in.) of the leader diameter  34 . The element outer diameter  38  can be larger than about 0.25 mm (0.010 in.) less than an inner diameter of a catheter through which the device  24  is deployed. The element outer diameter  38  can also be larger than about 2.0 mm (0.079 in.), more narrowly larger than about 2.7 mm (0.11 in.). An element length  42  can be in the aforementioned ranges for the element outer diameter  38 . 
         [0053]    A device volume can be determined by calculating the total volume of the elements  28 ,  30  and  32  added to the total volume of the leaders  26 . If the leader  26  or the elements  28 ,  30  and  32  are made from bioabsorbable materials, the reduction of device volume over time can be accounted for when calculating device volume. The device volume can be from about 20 cc (1.2 in. 3 ) to about 200 cc (12.2 in. 3 ), more narrowly from about 60 cc (3.7 in. 3 ) to about 100 cc (6.1 in. 3 ). 
         [0054]      FIGS. 4 and 5  illustrate an embodiment of the element  28  with the leader  26 . The elements  30  and  32  can have embodiments identical to the element  28 . The element  28  can be made from a first section  44  and a second section  46 . The first section  44  can be secured to the second section  46 . The sections  44  and  46  can have a section body  48  and an outer layer  50 . The section body  48  can be solid, solid with one or more dimples or channels, or hollow. The outer layer  50  can be a porous membrane or have macroscopic holes or channels that are in communication with the section body  48 . The element  28  can have one or more leader channels  52  having leader channel diameters  54  about equal to or greater than the leader diameter  34 . The leader channels  52  can be fixed to the leader  26 . Alternatively, the leader  26  can have a clearance with the leader channels  52 . A ferrule  56  can be fixed to the leader  26 . The ferrule  56  can be locked with an interference fit into a ferrule cavity  58 . 
         [0055]      FIGS. 6 and 7  illustrate an embodiment of the first section  44  and the element  28 , respectively.  FIGS. 8 and 9  illustrate another embodiment of the first section  44  and the element  28 , respectively. In the embodiments shown in  FIGS. 6-9 , the sections  44  and  46  can be identically shaped. In the embodiments in  FIGS. 4-7 , the sections  44  and  46  can be shaped to fit the opposite section  44  or  46  and form an interference fit, for example a snap lock, with the opposite section  44  or  46 . The interference fit minimizes movement of the sections  44  and  46  with respect to each other in any direction. In the embodiments in  FIGS. 8 and 9 , the sections  11  and  46  can be shaped to fit the opposite section  44  or  46  and form an interference fit that allows movement of the sections  44  and  46  with respect to each other in one translational direction. 
         [0056]      FIG. 10  illustrates a segment of an embodiment of the device  24  with the leaders  26  having first ends  60  and second ends  62  that can be integrated and conjoined segments of the elements  28 ,  30  and  32 . A “segment” can be a portion or section of any part, a whole part, or groups of parts. A “segment” can be integral with or distinct from other parts. The leaders  26  can be preformed resilient structures formed into helical shapes. The device  24  can be made entirely from the leader  26  and without elements  28 ,  30  and  32 , as illustrated in  FIG. 11 , or each element  28 ,  30  or  32  can be separated from the adjacent elements  28 ,  30  and  32  by as few as about 0.5 turns of the leader  26 . More narrowly, each element  28 ,  30  or  32  can be separated from the adjacent elements  28 ,  30  and  32  by from about 2 turns to about 3 turns of the leader  26 . The leaders  26  can have a preformed leader depth  64  from about 0.25 mm (0.0098 in.) to about 2.0 mm (0.079 in.), more narrowly from about 0.5 mm (0.02 in.) to about 1.0 mm (0.039 in.), and a preformed leader width  66  from about 0.5 mm (0.02 in.) to about 4.0 mm (0.16 in.), more narrowly from about 1.0 mm (0.039 in.) to about 2.0 mm (0.079 in.). The leaders  26  can also have wind lengths  68 . The wind lengths  68  can be the longitudinal component of the length covered by about 360 degrees of helical turn in the element  28 ,  30  or  32 . The wind lengths  68  can be about 2.0 mm (0.079 in.). The wind lengths  68  can also vary within a single element  28 ,  30  or  32 , and five wind lengths  68  can be about 1.0 cm (0.39 in.). 
         [0057]    The device  24  can be structurally reinforced. For example, a structural reinforcement  70  can be integrated onto the surface or encased by the leader  26  and/or the elements  28 ,  30 , and  32 . The reinforcement can be a binding agent, a polyester weave, or a coil or spirals element, for example a continuous wire wound within the device  24  such that the reinforcement  70  parallels the coils or helical shapes of the conjoined elements  28 ,  30  and  32  of the device  24 . 
         [0058]    In other embodiments of the device  24  illustrated in  FIGS. 12 a   - c,  the leaders  26  can have a male interference-fit piece, for example brads or poppets  72 , on a first end  60  of the leaders  26 . The second ends  62  of the leaders  26  can be integrated and conjoined with the elements  28 ,  30  and  32 . The elements  28 ,  30  and  32  can have female interference-fit pieces, for example plugs or sockets  74 , integrated into the elements  28 ,  30  and  32  at the opposite ends of the elements  28 ,  30  and  32  from the poppets  74 . A “piece” can be a leader, element, fiber, body, bladder, poppet or any other elements or group of elements or a segment of an element or groups of elements. The poppets  72  and sockets  74  can be shaped and sized to attach to each other with a sufficient interference fit to impede removal of the poppets  72  from the sockets  74 . The elements  28  and  30  at open ends  76  of the device  24  do not attach to a neighboring element  28 ,  30  and  32 . The elements  28  and  30  at the open ends  76  can lack the poppet  72  or the socket  74  on the open ends  76  of the elements  28  and  30 . 
         [0059]    In another embodiment of the device  24  illustrated in  FIG. 13 , the first end  60  of the leader  26  can have a first male interference-fit piece, for example a first poppet  72   a,  and the second end  62  of the leader  26  can have a second male interference-fit piece, for example a second poppet  72   b.  A leader with male interference-fit pieces at two ends can be called a “dogbone”. The elements  28 ,  30  and  32  can have two female interference-fit pieces, for example sockets  74 , integrated into opposite ends of each element  28 ,  30  and  32 . 
         [0060]      FIG. 14  illustrates a segment of an embodiment of the device  24  having first leaders  26   a  with ends  60  and  62  that can be integrated and conjoined segments of the elements  28  and  30  and a second leader  26   b  that can pass through the first leaders  26   a  and the elements  28  and  30 . The second leader  26   b  can have an interference fit at one open end  76 , for example a knot  78 . The second leader  26   b  can be fixed or slidably attached to the elements  28  and  30 . 
         [0061]    Radiopaque materials known to one having ordinary skill in the art can be used anywhere in or on the device  24 . Examples of radiopaque materials are barium, barium sulfate, titanium, stainless steel, nickel-titanium alloys (e.g., NiTi), and gold. The ferrule  56  can be made from radiopaque materials. A radiopaque patch or contrast agent can also be integrated into or placed on the leader  26  or the elements  28 ,  30 , and  32 . The contrast agent can be permanent or can be adapted to extravagate over time post-implantation. A radiopaque fiber can be wound integrally with the leader  26 . The radiopaque element can be present in a quantity sufficient to allow the operator to view deployment of the device  24  upon delivery, but not sufficient to obstruct the visualization of adjacent tissues and structures post-implantation. For example, upon deployment, the operator can visualize the initial placement. and nesting of the elements  28 ,  29  and  30  and/or the leader  26 , but post-implantation the visualization of the prosthesis  8  can be unobstructed by the radiopaque nature of the elements  28 ,  29  and  30  and/or the leader  26 . 
         [0062]    The elements  28 ,  30  or  32  can be filled or coated with an agent delivery matrix known to one having ordinary skill in the art and/or a therapeutic and/or diagnostic agent and/or a binding agent. The device  24 , or any of the parts of the device  24 , can be coated with the agents. These agents can include radioactive materials; radiopaque materials, for example gold; thrombogenic agents, for example polyurethane, cellulose acetate polymer mixed with bismuth trioxide, and ethylene vinyl alcohol; lubricious, hydrophilic materials; phosphor cholene; anti-inflammatory agents, for example non-steroidal anti-inflammatories (NSAIDs) such as cyclooxygenase-1 and 2 (COX-1 and COX-2) inhibitors (e.g., acetylsalicylic acid, for example ASPIRIN® from Bayer AG, Leverkusen, Germany; ibuprofen, for example ADVIL® from Wyeth, Collegeville, Pa.; indomethacin; mefenamic acid), COX-2 specific inhibitors (e.g., VIOXX® from Merck &amp; Co., Inc., Whitehouse Station, N.J.; CELEBREX® from Pharmacia Corp., Peapack, N.J.; COX-1 inhibitors); immunosuppressive agents, for example Sirolimus (RAPAMUNE®, from Wyeth, Collegeville, Pa.), or matrix metalloproteinase (MMP) inhibitors (e.g., tetracycline and tetracycline derivatives) that act early within the pathways of an inflammatory response. Examples of agents can also include gel, for example, hydrogel, xerogel, aerogel, gelatin (e.g., bovine-derived gelatin), agar, sugars and combinations thereof. Examples of other agents are provided in Walton et al, Inhibition of Prostoglandin E 2  Synthesis in Abdominal Aortic Aneurysms,  Circulation, Jul.  6, 1999, 48-54; Tambiah et al, Provocation of Experimental Aortic Inflammation Mediators and Chlamydia Pneumoniae,  Brit. J. Surgery  88 (7). 935-940; Franklin et al, Uptake of Tetracycline by Aortic Aneurysm Wall and Its Effect on Inflammation and Proteolysis,  Brit. J. Surgery  86 (6), 771-775; Xu et al, Sp1 Increases Expression of Cyclooxygenase-2 in Hypoxic Vascular Endothelium,  J. Biological Chemistry  275 (32) 24583-24589; and Pyo et al, Targeted Genre Disruption of Matrix Metalloproteinase-9 (Gelatinase B) Suppresses Development of Experimental Abdominal Aortic Aneurysms,  J. Clinical Investigation  105 (11), 1641-1649 which are all incorporated by reference in their entireties. Binding agents can include any of the aforementioned agents suitable for binding and a polyester weave, a coil or spiral element, a net, or other, mesh, or a combination thereof Once the device  24  is deployed, these agents can provide various benefits such as i) promoting fusing of the space-occupying elements  28 ,  30  or  32  to each other or to the surrounding biologic materials (e.g., a collagen coating), and/or ii) promoting a thrombogenic response within the sac  10  to stabilize the device  24  and the prosthesis  8 , and/or iii) promoting healing of the aneurysm at the cellular level such as in the case of treating an inflammatory response, and/or iv) controlling the flexibility of the device  24 . 
         [0063]      FIG. 15  illustrates a segment of an embodiment of the device  24  that can be similar to the embodiment illustrated in  FIG. 10 or 11 . The device  24  can be coated with a binding agent.  132 . (The binding agent  132  is transparent with outlines for illustrative purposes in  FIGS. 15 .  16   a  and  16   b ). The device  24  can be substantially fully longitudinally compressed before being coated and, for example, held in a cylindrical configuration by the binding agent  132 . The device  24  can be placed over a wire, mandrel and/or a delivery catheter (riot shown). While in a compressed configuration, portions of the device  24  can also overlap the device  24 , itself. The binding agent  132  can be any agent listed above or combinations thereof. The binding agent  132  can have a binding agent thickness  134  from about 0.01 mm (0.0005 in.) to about 1.3 mm (0.050 in.), for example, about 0.25 mm (0.010 in.). The binding agent  132  can be in a substantially solid form before use. The binding agent  132  can transitionally decrease the flexibility of the device  24  during deployment. The binding agent  132  can increase the column strength of the device  24 , thereby enhancing the pushability of the device  24  by a hollow pusher rod or ramming catheter  135 . 
         [0064]    The binding agent  132  can cover the seams of the leader  26 , as shown by the binding agent on the leader  26  between the first and second elements  28  and  30 . The binding agent  132  can also expose the seams of the leader  26 , as shown by the leader  26  between the second and third elements  30  and  32 . 
         [0065]    A first device can also be placed against a longitudinal end of a second device, forming a butt joint. The butt joint can be covered in the binding agent  132 . The first and devices can therefore be constrained to each other at the butt joint. 
         [0066]      FIGS. 16 a  and 16 b    illustrate a segment of an embodiment of the device  24  that can be woven from fibers  136 . The fibers  136  can be woven into a cylindrical configuration and coated with the binding agent  132 . The fibers  136  can be made from any of the materials listed for the leader  26  or the elements  28 ,  30  and  32  or any combination thereof. The fibers  136  can have a fiber pitch  137  from about 45° to about 80°.  FIG. 16 a    illustrates the device  24  in a first state that can have a smaller fiber pitch  137  than the device  24  in a second state illustrated in  FIG. 16   b.  Due to a coating of the binding agent  132 , the device  24  can be held at a pre-selected fiber pitch  137  during all or part of use (e.g., during deployment). The fibers  136  can have a fiber diameter  139  from about 0.03 mm (0.001 in.) to about 1.0 mm (0.04 in.), more narrowly from about 0.1 mm (0.005 in.) to about 0.25 mm (0.010 in.). 
         [0067]      FIG. 17  illustrates an embodiment of the device  24  that can have a combination of the above embodiments in alternating states of tension and compression to minimize or completely prevent longitudinal expansion of the device  24 . A first sub-device  24   a,  for example the woven embodiment of the device  24  illustrated in  FIG. 16 a    or  16   b,  with or without the binding agent  132 , can be radially surrounded by a second sub-device  24   b  (shown as a cut-away view for illustrative purposes), for example the helical embodiment of the device  24  illustrated in  FIG. 11 . The second sub-device  24   b  can be radially surrounded by a binding agent  132 , for example a radial constraining device such as a net (shown only at one end of the device  24  and as a cut-away view for illustrative purposes). 
         [0068]    The first and second sub-devices  24   a  and  24   h  and the constraining device  141  can be fixedly attached at both longitudinal ends to end caps  143 . The first sub-device  24   a  can be in tension when fixedly attached to the end caps  143 . The second sub-device  24   b  can be in compression when fixedly attached to the end caps  143 . The orientation of the tension and compression of the first and second sub-devices  24   a  and  24   b  can be reversed. 
         [0069]      FIG. 18  illustrates an embodiment of the device  24 . The device  24  can have a body  138  that can have a fillable bladder, for example a woven, knit or doubleknit polyester fabric hag. The body  138  can be sized and shaped to fit a specific sac  10 , for example, based on visualization data from a visualization tool used before the device  24  is deployed. Alternatively or in conjunction with the aforementioned sizing and shaping, numerous, small, discrete devices  24  (e.g., bodies  138 ) can be used to fill a specific sac  10 . The device  24  can be large enough to minimize the risk that after the device is deployed that the device  24  might pass into the bloodstream and become an embolus, but optionally fillable with particles  145  that could otherwise be small enough to embolize. 
         [0070]    The fillable bladder and the body  138  can be the same or different elements. The body  138  and/or the bladder can be made from any material listed above for the leader  26 , the elements  28 ,  30  or  32  or any combination thereof. The body  138  and/or the bladder can be permeable to body fluids and/or a filling agent. The body  138  can have very fine pores. The body  138  can have a proximal port  142  at a proximal end  140  of the body  138 . A filler tube  144  can be placed in the proximal port  142  and provide access to the inside of the bladder and/or the body  138 . At the proximal end  140 , the body  138  can have a neck  146 . The neck  146  can have a seal  148 , for example a sealing band or valve. When closed, the seal  148  can be substantially fluid-tight or the seal  148  can be less than about 8 mm (0.3 in.) diameter. The proximal end of the filler tube  140  can be attached to a syringe connecter  150 , for example, a syringe port or connector known to one having ordinary skill in the art. A guidewire  152  can pass into the proximal end  140  of the body  138 . The guidewire  152  can pass out of the body  138  at the guidewire port  154  to allow delivery of the bladder from an over-the-wire catheter. The guidewire port  154  can form a substantially fluid-tight seal with the body  138 . The device  24  can also be used without the guidewire  152  and the guidewire port  154  can be absent in the device  24 . 
         [0071]    The body  138  and/or the bladder can contain the filling agent. The body  138  and/or the bladder can be pre-filled with the filling agent or injected with the filling agent as described above. The filling agent can be in the form of particulates, for example, pellets, pieces, chunks, chips, powder, fluid, gel or a combination thereof. The filling agent can be made from any material listed for the agent, the leader  26  the element  28 ,  30  or  32  or combinations thereof. The filling agent can be larger than any openings on the body  138  during use (e.g., pores, ports, or seals) to minimize the filling agent exiting the body  138  and entering the bloodstream. 
         [0072]      FIG. 19  illustrates an embodiment of the device  24  similar to the embodiment of the device  18  illustrated in  FIG. 18 . The device  24  can have a body  138  that can have a fillable bladder  156 . The body  138  can also have a bladder seal  158  substantially around the perimeter of the body  138 . The bladder seal  158  can be, for example, a glue, heat or stitch seal. The body  138  can have various geometric configurations including a substantially square, rectangular, semi-elliptical (e.g., hemi-elliptical), elliptical, semi-circular (e.g., hemi-circular), circular, oblong, or totally irregular shape. The shape of the body  138  can promote the body  138  to conform with the sac  10  morphology to increase the thrombogenicity in the sac  10 , while the shape of the body  138  can still encourage containment of the body  138  within the sac  10  to minimize risk of the body  138  becoming an embolus in the bloodstream. The proximal port  142  can be in the corner or the side of the bladder seal, or orthogonally out of the face of the bladder  156 . 
       Method of Making 
       [0073]    The elements  28 ,  30  and  32  and the leader  26  can be made from methods known to those having ordinary skill in the art. For example, the elements  28 ,  30  and  32  can be molded or machined. The embodiments of the device  24  illustrated in  FIGS. 10, 11, 14 and/or 15  can be extruded and then a helical cut in the extrusion can be made by a blade, laser, water jet or hot wire to form the leaders  26  and  26   a.    
         [0074]    The elements  28 ,  30  and  32  can be molded, machined, or mounted onto the leader  26 . The elements  28 ,  30  and  32  can be mounted to the leader  26  with an interference fit, for example by tying knots in the leader  26  surrounding the elements  28 ,  30  and  32  mounting the elements  28 ,  30  and  32  onto the ferrule  56  which is already crimped onto the leader  26 . The elements  28 ,  30  and  32  can be pressure fitted onto the leader  26 , for example by crimping the elements  28 ,  30  and  32  onto the leader  26 , snapping snap-together sections  44  and  46  onto the leader  26 , or distortion mounting by heating the elements  28 ,  30  and  32  to a threshold of thermal distortion. The elements  28 ,  30  and  32  can be glued onto the leader  26  with a biocompatible adhesive (e.g., cyanoacrylate); bonded ultrasonically; or heat bonded (e.g., melting, heat welding). Each section  44  or  46  can be attached to the other section  44  or  46  with any of the above methods. 
         [0075]    Any part of the device  24 , or the device  24  as a whole after assembly, can be coated by dip-coating or spray-coating methods known to one having ordinary skill in the art. One example of a method used to coat a medical device for vascular use is provided in U.S. Pat. No. 6,358,556 by Ding et al. and hereby incorporated by reference in its entirety. Time release coating methods known to one haying ordinary skill in the art can also be used to delay the release of an agent in the coating, for example inclusion of a collagen matrix in the coating. 
         [0076]    The device  24  can be coated with the binding agent  132  while the leader  26  is in a closed position, as shown by the binding agent on the leader  26  between the first and second elements  28  and  30  in  FIG. 15 . The device  24  can be coated with the binding agent  132  while the leader  26  is in an opened position, as shown by the binding agent on the leader  26  between the second and third elements  30  and  32  in  FIG. 15 . Depending on the relaxed state of the leader  26 , the leader  26  can be opened and/or closed by twisting, necking, compressing or extending. 
       Method of Use 
       [0077]    Before using the device  24 , the sac  10  can be cleaned of debris (e.g., thrombi), for example, by mechanically macerating the debris or using a lytic agent (e.g., Urokinase, for example Abbokinase® from Abbott Laboratories, Abbott Park, Ill.). Examples of devices capable of performing pharmomechanical treatment—that can be delivered to the sac  10  through the same delivery apparatus as the device  24 —are the TRELLIS™ and FINO™ from Bacchus Vascular, Inc. (Santa Clara, Calif.). Use of the device  24  can be performed while using a visualization tool, for example fluoroscopy or computed tomography (CT) scanning. The volume of the sac  10  not filled by debris can be estimated from visual inspection, for example by inspection of images from the visualization tool. Software known to one having ordinary skill in the art can also be used to assist in estimating the volume of the sac  10 . 
         [0078]    A length of the device  24  can be stored in a sterile package, for example by an individual predetermined length, or on a spool, spindle, or in a cartridge. The device volume can be reduced by removing more than enough of the device  24  from the sterile package and then reducing the length of the device  24 , for example, by cutting the leader  26  or unplugging a poppet  72  from a socket  74 . In this way, the device volume can be reduced to the approximate volume of the sac  10  not filled by debris. The device volume can be large enough to substantially fill the vascular site, and the device volume can be small enough to prevent substantial alteration of the natural fluid flow through the prosthesis  8 . 
         [0079]    The device  24  can be deployed to the sac  10  using a trans-graft, trans-collateral, trans-sac, or endoluminal procedure. As illustrated in  FIG. 20 , a catheter  80  with a distal exit  82  can be placed in the aneurysm  4 . The distal exit  82  can be placed at the sac  10 . The device  24  can then be passed through the catheter  80  and distal exit  82 , and the device  24  can be deployed into the sac  10 . 
         [0080]    As illustrated in  FIG. 21 , a catheter clearance  84  is the distance between the device  24  and an inner wall  86  of the catheter  80 . The inner walls  86  of the catheter  80  can act as a guide for the device  24  during deployment. If the catheter clearance  84  is too large, the inner walls  86  of the catheter  80  can no longer act as a guide and the device  24  can “boxcar” within the catheter  80 . Boxcarring occurs when the elements  28 ,  30  and  32  bunch up and impair delivery, preventing an upstream element from transmitting force to a downstream element in a direction substantially parallel with the inner walls  86 . The maximum catheter clearance  84  before the elements  28 ,  30  and  32  can begin to boxcar is the “critical clearance”. The critical clearance can be about 80% of the element outer diameter  38 , more narrowly about 26% of the element outer diameter, yet more narrowly about 12% of the element outer diameter  38 . 
         [0081]    As illustrates in  FIG. 15 , the device  24  can be propelled during deployment by pushing (as shown by the arrow) the device  24  with the pushing rod or ramming catheter  135 . The ramming catheter  135  can have an inner diameter  160  smaller than the outer diameter  162  of the device  24 . The ramming catheter  135  can have an outer diameter  164  larger than the outer diameter  162  of the device  24 . 
         [0082]    If the device  24  is coated with a binding agent  132 , the device  24  can have an increased column strength and a decreased flexibility before use and during passage through the catheter  80 . The binding agent  132  can be exposed to a softening agent during use. The softening agent can soften the binding agent  132  and can increase the flexibility of the device  24  during use. 
         [0083]    While the device  24  is passed through the catheter  80 , the device  24  can be substantially separated from the softening agent. The device  24  can be exposed to the softening agent when the device  24  exits the distal exit  82  and is placed in the aneurysm  4 . Softening agents can be blood, other body fluids, other agents known to one having ordinary skill in the art, or combinations thereof. Softening agents can be injected through the catheter  80  at the time of deployment, thereby exposing the device  24  to the softening agents within the catheter  80  so the device becomes more flexible as the device  24  exits the catheter  80 . 
         [0084]    An end of the catheter  80  can have a valve  87  to minimize or completely prevent backflow of body fluids or other leakage and improve the connection of other devices to the end of the catheter  80 . Use of the valve  87  at the end of the catheter  80  is understood to one having ordinary skill in the art. The valve  87  can be, for example, a hemostasis valve (e.g., from Cook, Inc., Bloomington, Ind.). 
         [0085]    A method of deploying the device  24  illustrated in  FIG. 18 or 19  can include deflating the body  138  and/or the bladder  156  (for ease of description, hereafter referred to collectively as the body  138 ) to place the device  24  into the catheter  80 . The filler tube  144  and/or syringe connector  150  can be attached to the body  138  before or during the procedure. The seal  148  can be partially closed to seal around the filler tube  144 . The body  138  can be passed through a catheter and positioned in the sac  10 . The guidewire  152  can be used to direct the body  138 . 
         [0086]    Once in a desired position in the sac  10 , the guidewire  152  can be removed from the body  138 . A syringe or catheter can be attached in fluid communication to the filler tube  144  and/or syringe connector  150 . The body  138  can then be filled with a particulate, a flowable material under pressure, or a combination thereof. The particulate can be an expandable material. The particulate can expand, for example, when exposed to body fluids. The flowable material can be a solidifying agent, for example, a gel, stereolithography polymers, a recently-prepared fast setting polymer, or a combination thereof. The body  138  can be pre-filled (e.g., filled before deployment of the body  138  into the sac  10 ). The body can be filled by a combination of pre-filling and filling after the deployment of the body  138  into the sac  10 . 
         [0087]    When the body  138  is filled to a desired size and shape, the flow of flowable material can be stopped. The flowable material can then be caused to harden or solidify, for example, by exposure to a second material, heating, cooling, exposure to RF radiation (e.g., UV light), time exposure, or a combination thereof. The filler tube  144  can be removed from the body  138  and the seal  148  can be fully sealed. Any amount of the flowable material can also exit the body  138  by the pores in the body  138 . The flowable material can have an agent for example, any of the therapeutic agents, diagnostic agents, radiopaque agents or binding agents listed above, or combinations thereof. 
         [0088]      FIG. 22  illustrates a method of deploying multiple devices  24  to the sac  10 . The devices  24  can be fillable, for example the embodiments shown in  FIG. 18 or 19 . The devices  24  can be small enough to fit multiple devices  24  into the sac  10 . The devices  24  can be deployed using a delivery catheter known to one having ordinary skill in the art with or without the guidewire  152 . 
         [0089]      FIG. 23  illustrates a ratcheting driver  88  having a feed tube  90  that can be used to control the device  24  during deployment. The device  24  can pass through a channel  92  in the feed tube  90 . An end  94  of the feed rube  90  can connect to the valve  87  or the catheter  80 . The driver  88  can have a spring-loaded handle  96 . The handle  96  can be connected to a ram  98 . The handle  96  can move along a track  100  in the feed tube  90 . When the handle  96  is pushed, the ram  98  can press the device  24  forward through the channel  92 . When the handle  96  is released, the handle  96  can revert to a starting position and prevent the device  24  from moving backwards through the channel  92 . 
         [0090]      FIG. 24  illustrates a sliding driver  88  having a slider  102 . The slider  102 , illustrated in  FIG. 25 , can have a rib  104  that can engage the track  100 . The slider  102  can abut and deliver a force to the end of the device  24  when the device  24  is in the channel  92 . 
         [0091]    The geometries of the elements  28 ,  30  and  32  of the device  24  and the properties of the leader  26  can benefit delivery of the device  24 . As the slider  102  delivers force to the end of the device  24 , the leader  26  can buckle or flex, allowing elements  28 ,  30  and  32  to approximate and transmit force from one element  28 ,  30  or  32  to the other elements  28 ,  30  or  32 , thereby giving the device  24  sufficient column strength to move through the channel  92 . 
         [0092]    As illustrated in  FIG. 26 , a connector  106  at the end  94  of the feed tube  90  can have a lipped hub  108  and a collar  110 . The lipped hub  108  can feed into the valve  87  or the opening of a channel in the catheter  80 . The collar  110  can fit over the valve  87  or the end of the catheter  80  that joins with the feed tube  90 , or the collar  110  can join with another intermediary device between the catheter  80  or the valve  87  and the feed tube  90 . The connector  106  can have a check port  112  in the collar  110 . 
         [0093]      FIGS. 27-30  illustrate an embodiment of the connector  106  that can lock to, and unlock from, the catheter  80 . A first end of the connector  106  can have a latch  114  that can form a friction or interference fit with the valve  87  or the catheter  80  (not shown) when the valve  87  or the catheter  80  is loaded into the collar  110  past the latches  114 . The latches  114  can be rigidly attached to lever arms  116 . The lever arms  116  can be attached to the connector  106  at an attachment location  118  so that the position of the lever arms  114  forces the latches  114  to form the fiction or interference fit with the valve  87  or the catheter  80  when no external forces are applied to the lever arms  116 . A second end of the lever arm  116  can also have a press tab or button  120 . 
         [0094]    When a force (shown by arrows in  FIG. 28 ) is applied to the buttons  120 , the lever arms  116  can rotate around the attachment location  118 , removing the friction or interference fit between the latches  114  and the valve  87  or the catheter  80 . 
         [0095]    The connector  106  can have a lock  122  that can be rotatably attached to the remainder of the connector  106 . Tabs  124  can protrude from the lock  122 . The tabs  124  can be used to aid rotation (shown by arrows in  FIGS. 27 and 29 ) of the lock  122  relative to the remainder of the connector  106 , and to provide an interference fit to prevent the lock  122  from turning from one lever arm  114  past the next lever arm  114 . The lock  122  can have a thick portion  126  and a thin portion  128 . 
         [0096]    The lock  122  can be rotated to position the thick portion  126  between the lever arms  116  and a retaining wall  130  (shown in  FIGS. 29 and 30 ), minimizing the rotation of the lever arms  116  and preventing the removal of the friction or interference fit between the latches  114  and the valve  87  or the catheter  80 . With the lock  122  in this position, the valve  87  or the catheter  80  can be locked to the connector  106 . 
         [0097]    The lock  122  can be rotated to position the thin portion  128  between the lever arms  116  and the retaining wall  130  (shown in  FIGS. 27 and 28 ), allowing substantially free rotation of the lever arms  116  and enabling removal of the friction or interference fit between the latches  114  and the valve  87  or the catheter  80 . With the lock  122  in this position, the valve  87  or the catheter  80  can be unlocked and removed from the connector  106 . 
         [0098]    The driver  88  can be integrated with the sterile package (e.g., individual predetermined length, spool, spindle, or cartridge) loaded with the device  24 . A new package loaded with the device  24  can replace or be swapped for an old package at the connector  106 . 
         [0099]    The device  24  can be visualized by the visualization tool before, during and after the device  24  has been deployed. After the device  24  has been deployed, any agents in or on the device  24  can elute into the tissue and fluids. The vascular prosthetic  8  can be implanted before, during or after the device  24  is deployed. 
         [0100]    It is apparent to one skilled in the art that various changes and modifications can be made to this disclosure, and equivalents employed, without departing from the spirit and scope of the invention.

Technology Classification (CPC): 0