Patent Abstract:
An inflatable structure for use in biological lumens and methods of making and using the same are disclosed. The structure can have an inflatable balloon encircled by a shell. The shell can have proximal and distal tapered necks, longitudinally-oriented flutes, and apertures at the proximal and distal ends of the shell. The apertures can be recessed in the flutes in the necks. The shell can also have fiber reinforced walls.

Full Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    The present application claims priority to U.S. Provisional Application No. 61/433,896 filed 18 Jan. 2011; and 61/486,720 filed 16 May 2011, both of which are incorporated herein by reference. 
     
    
     BACKGROUND 
       [0002]    1. Technical Field 
         [0003]    Inflatable medical devices and methods for making and using the same are disclosed. More narrowly, medical invasive balloons, such as those used for trans-cutaneous heart valve implantation are disclosed. For example, those balloons used for trans-catheter aortic-valve implantation. 
         [0004]    Inflatable structures are widely used in medical procedures. A structure is inserted, typically on the end of a catheter, until the structure reaches the area of interest. Adding pressure to the structure causes the structure to inflate. In one variation of use, the structure creates a space inside the body when the structure inflates. 
         [0005]    Inflatable structures may be used in the heart valves, including during Balloon Aortic Valvuloplasty (BAV) and Transcatheter Aortic Valve Implantation (TAVI). The structures can be used to open a stenosed aortic valve. A stenosed valve may have hard calcific lesions which may tend to tear or puncture a structure. Additionally, a precise inflated structure diameter may be desired for increased safety and control. 
         [0006]    Inflatable structures may be used to move plaque or a constriction away from the center of a vascular or other lumen toward the lumen walls, such as during an angioplasty or a peripheral vasculature or an airway procedure. During this procedure, an inflatable structure on the distal end of the catheter is placed in an obstruction. As the structure is inflated, the constriction is dilated, resulting in improved flow of the liquid (such as blood) or gas (such as air). 
         [0007]    Current or typical inflatable structures can be balloons. When a typical balloon inflates, it may block a body lumen. For instance, a typical balloon may block the flow of blood in the vasculature or air in the airway. Blocking this vital supply of liquid or gas may cause short or long term health problems for the patient. This blockage may minimize the time that the physician can keep a balloon inflated during medical procedure. 
         [0008]    Typical balloons, when used to perform a BAV and/or TAVI procedure will block the entire output of the heart at the aortic valve. This causes the pressure in the heart to increase to uncomfortable levels. It may also generate enough force to eject the balloon from the aortic valve. Finally, typical balloons provide poor dimensional (particularly diametric) control and do not resist tear and puncture (from, for instance, aortic calcifications) well. 
         [0009]    Alternately, a physician may use rapid pacing of the heart (artificially accelerating the natural heart beat pace) during BAV and/or TAVI to minimize pressure buildup and the forces on the balloon. However, rapid pacing carries risk for the patient as well. Even with rapid pacing, typical balloons may only be inflated for a few seconds before being withdrawn and still suffer from poor dimensional control and toughness. 
         [0010]    A balloon or inflatable structure is desired that can maintain flow of liquid or gas while providing precise shape control and being highly resistant to tear and puncture. 
       SUMMARY OF THE INVENTION 
       [0011]    An inflatable medical device such as inflatable structure apparatus is disclosed. The apparatus can have a shell having a shell longitudinal axis, a central section and a first neck section. The first neck section can have a first neck first end and a first neck second end. The first neck first end can have a first neck first end diameter. The first neck second end can have a first neck second end diameter. The first neck first end diameter can be larger than the first neck second neck diameter. The first neck first end can be adjacent to the central section. 
         [0012]    The apparatus can have a balloon at least partially inside of the shell. The balloon can be fixed in the shell. 
         [0013]    The shell can have a shell longitudinal axis and a central fluid passage. The central fluid passage can be radially inside of the balloon with respect to the shell longitudinal axis. The first aperture can be in fluid communication with the central fluid passage. The balloon can have a first cell and second cell in a single cross-section of the inflatable structure. The balloon can have a balloon surface area in the single cross section. At least 5% of the balloon surface area can be concentric (i.e., have the same center of radius of curvature) with the shell. 
         [0014]    A wall of the first cell adjacent to the second cell can be greater than about 5% in contact with the second cell. The apparatus can have a first flute in the shell. The first flute can have a first flute first inner pleat, a first flute second inner pleat, and a first flute outer pleat between the first flute first inner pleat and the first flute second inner pleat. The apparatus can have a first aperture. The first aperture can be at least partially on the first flute. The first aperture can be arranged as to not cross the first flute outer pleat. 
         [0015]    The first neck section can have a first neck section stiffness. The central section can have a central section stiffness. The first neck section stiffness can be greater than the central section stiffness. 
         [0016]    The apparatus can have a tube extending along the shell longitudinal axis. The central fluid passage can be between the tube and the inside radius of the balloon with respect to the shell longitudinal axis. The tube can have a lumen extending therethrough. 
         [0017]    The first neck section can have a first neck section average wall thickness. The central section can have a central section average wall thickness. The first neck section average wall thickness can be greater than the central section average wall thickness. The first flute can be in the first neck section. 
         [0018]    At least 30% of the perimeter of the shell can be concentric with the balloon surface area. The balloon can have a first cell and second cell in a single cross-section of the inflatable structure. At least 30% of the perimeter of the shell can be in contact with the cells. 
         [0019]    The balloon can have a first cell and second cell in a single cross-section of the inflatable structure. At least 5% of the balloon surface area can be in contact with the shell. 
         [0020]    The apparatus can have a second flute. The first aperture can be covered by the second flute when the inflatable structure is in a deflated configuration. The second flute can have a second flute first inner pleat, a second flute second inner pleat, and a second flute outer pleat between the second flute first inner pleat and the second flute second inner pleat. The apparatus can have a second aperture. The second aperture can be at least partially on the second flute. The second aperture can be arranged to not cross the second flute outer pleat. 
         [0021]    The shell can have a second neck section. The second neck section can have a second neck first end and a second neck second end. The second neck first end can have a second neck first end diameter. The second neck second end can have a second neck second end diameter. The second neck first end diameter can be greater than the second neck second end diameter. The second neck first end can be adjacent to the central section. 
         [0022]    The apparatus can have a second aperture on the second neck section. The first aperture and the second aperture can be in fluid communication with the central fluid passage. 
         [0023]    The central section can have a central section diameter. The central section diameter can be constant along the length of the central section. The balloon can be at least partially in the central section of the shell. 
         [0024]    The shell can have a shell wall having a fiber. The shell can be non-compliant. The shell can have a fiber. 
         [0025]    A method for using an inflatable structure in a biological body is disclosed. The method can include positioning the inflatable structure at an aortic valve in the body. The inflatable structure can have a balloon that can have first and second flexed flexion sections. The method can include inflating the balloon. The method can include perfusing the aortic valve. Perfusing can include perfusing through the inflatable structure. Perfusing can occur while the balloon is inflated. 
         [0026]    The aperture can be in fluid communication with the central fluid passage. 
         [0027]    The method can also include expanding the expandable implant. The expanding of the expandable implant can include inflating the inflatable structure. At least some of the flow routes through the aperture and central fluid passage. The method can include separating the expandable implant from the inflatable structure. 
         [0028]    A method for using an inflatable structure in a biological body is disclosed. The method can include positioning the inflatable structure at an aortic valve in the body. The inflatable structure can have a shell. The balloon can be at least partially inside the shell. The shell can have a shell longitudinal axis and a central fluid passage radially inside of the balloon with respect to the shell longitudinal axis. The shell can have a flute and an aperture on the flute. The aperture can be in fluid communication with the central fluid passage. The method can include inflating the balloon. The method can include perfusing the aortic valve. Perfusing can include perfusing through the inflatable structure. 
         [0029]    A method of manufacturing the inflatable structure is disclosed. The method can include making a shell. The shell can have a central section, a first neck section, and a second neck section. The first neck section can be distal to the central section and the second neck section can be proximal to the central section. The method can include cutting apertures in the first neck section. The method can include loading the balloon into the shell. The method can include pressing the balloon again the shell. The method can include fixing that balloon to the inside of the shell. 
         [0030]    Making the shell can include applying a first film on the first neck section, and applying a second film to the first neck section. Making the shell can include adding a first layer and a second layer to the shell. The first layer can have a first fiber. The second layer can have a second fiber. The method can include compressing the balloon in the shell. Compressing can include forming the balloon such that at least 5% of balloon circumference can contact the shell in the central section of the shell. Loading can include inserting the balloon through the aperture. 
         [0031]    Another method of manufacturing the inflatable structure is disclosed. The method can include forming a balloon along a longitudinal axis of the balloon. Forming can include bending the balloon at a flexion section of the balloon. The method can also include joining the balloon in a compression fixture. The compression fixture can have the same inner diameter as the shell. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0032]      FIG. 1A  illustrates a variation of the device. 
           [0033]      FIG. 1B  illustrates a variation of cross section A-A of  FIG. 1 . 
           [0034]      FIG. 2A  illustrates a variation of the device. 
           [0035]      FIG. 2B  illustrates a variation of the device. 
           [0036]      FIG. 2C  illustrates a variation of the device. 
           [0037]      FIGS. 3A through 3D  illustrate variations of the device. 
           [0038]      FIGS. 4 through 6  illustrate variations of the device. 
           [0039]      FIG. 7A  illustrates a variation of the device in a partially deflated condition. 
           [0040]      FIG. 7B  illustrates a variation of cross-section D-D of  FIG. 7A . 
           [0041]      FIG. 7C  illustrates a variation of cross-section E-E of  FIG. 7A . 
           [0042]      FIG. 7D  illustrates a variation of the device in a deflated condition. 
           [0043]      FIG. 8  illustrates a variation of the device. 
           [0044]      FIGS. 9A through 9D  illustrate variations of the device. 
           [0045]      FIGS. 10A through 10B  illustrate variations of cross-section B-B of  FIG. 1A . 
           [0046]      FIGS. 11A through 11B  illustrate variations of cross-section C-C of  FIG. 3C . 
           [0047]      FIGS. 12 through 14B  illustrate variations of the device. 
           [0048]      FIGS. 15 through 18  illustrate variations of the device. 
           [0049]      FIG. 19  illustrates a method of manufacturing a variation of the inflatable device. 
           [0050]      FIG. 20A  illustrates a variation of the device. 
           [0051]      FIG. 20B  illustrates a variation of a tool for manufacturing a variation of the inflatable device. 
           [0052]      FIG. 20C  illustrates a method of manufacturing a variation of the inflatable device. 
           [0053]      FIGS. 21 through 22B  illustrate variations of the device. 
           [0054]      FIG. 23A  illustrates a variation of the device. 
           [0055]      FIG. 23B  illustrates a variation of cross-section F-F of  FIG. 23A . 
           [0056]      FIG. 24A  illustrates a variation of the device. 
           [0057]      FIG. 24B  illustrates a variation of cross-section G-G of  FIG. 24A . 
           [0058]      FIG. 25A  illustrates a variation of the device. 
           [0059]      FIG. 25B  illustrates a variation of cross-section H-H of  FIG. 25A . 
           [0060]      FIG. 26A  illustrates a variation of the device. 
           [0061]      FIG. 26B  illustrates a variation of cross-section J-J of  FIG. 26A . 
           [0062]      FIG. 27A  illustrates a variation of the device. 
           [0063]      FIG. 27B  illustrates a variation of cross-section K-K of  FIG. 27A . 
           [0064]      FIG. 27C  illustrates a variation of  FIG. 27B  in a deflated state. 
           [0065]      FIG. 27D  illustrates a variation of a close-up cross sectional view of  FIG. 27B . 
           [0066]      FIG. 27E  illustrates a variation of a close-up cross sectional view of  FIG. 27C . 
           [0067]      FIG. 28A  illustrates a variation of cross-section K-K of  FIG. 27A   
           [0068]      FIG. 28B  illustrates a variation of  FIG. 28A  in a deflated state. 
           [0069]      FIG. 28C  illustrates a variation of a close-up cross sectional view of  FIG. 28A . 
           [0070]      FIG. 28D  illustrates a variation of a close-up cross sectional view of  FIG. 28B . 
           [0071]      FIGS. 29 through 31A  illustrate variations of the device. 
           [0072]      FIGS. 31B through 31C  illustrate details of an element shown in  FIG. 31A . 
           [0073]      FIG. 32A  illustrates a variation of the device. 
           [0074]      FIG. 32B  illustrates a variation of a cross section of the device shown in  FIG. 32A . 
           [0075]      FIG. 32C  illustrates a variation of the device. 
           [0076]      FIG. 32D  illustrates a variation of a cross section of the device shown in  FIG. 32C . 
           [0077]      FIGS. 33A through 33B  illustrate variations of the device. 
           [0078]      FIG. 34  illustrates a variation of the device in a deflated state. 
           [0079]      FIGS. 35A through 35D  illustrate variations of a fiber matrix. 
           [0080]      FIG. 36  illustrates a variation of a tool for manufacturing a variation of the inflatable device. 
           [0081]      FIGS. 37A through 37C  illustrate a variation of a method for manufacturing the device. 
           [0082]      FIG. 37D  illustrates a variation of cross-section L-L of  FIG. 37C . 
           [0083]      FIGS. 38A through 38B  illustrate a method for manufacturing the device. 
           [0084]      FIGS. 39A through 39C  are transverse cross-sections of variations of fiber tows in various configurations during a method of manufacturing. 
           [0085]      FIGS. 40A through 40H  illustrate a method of making a panel. 
           [0086]      FIGS. 41A through 42C  illustrate variations of a panel. 
           [0087]      FIGS. 43A through 43B  illustrate a method for manufacturing the device 
           [0088]      FIG. 44  illustrates a method for manufacturing the device. 
           [0089]      FIGS. 45A and 45B  illustrate a method for manufacturing the device 
           [0090]      FIGS. 46A through 46B  illustrate variations of a panel. 
           [0091]      FIG. 47  illustrates a variation of a method for removing the mandrel. 
           [0092]      FIGS. 48A through 48C  illustrate a method for manufacturing the device 
           [0093]      FIGS. 49A through 49F  illustrate a method for manufacturing the device 
           [0094]      FIG. 50  illustrates a variation of a deployment tool for the device. 
           [0095]      FIG. 51  illustrates a cross-section of a variation of the device contracted inside of a tube. 
           [0096]      FIG. 52  illustrates a cross section of a human heart. 
           [0097]      FIG. 53  is a graph showing the flow rate on the y-axis for a vascular lumen during stress and at rest corresponding with the percent stenosis of the lumen. 
           [0098]      FIGS. 54A through 54E  illustrate a variation of a method for using the device. 
           [0099]      FIGS. 55A through 55F  illustrate a variation of a method for using the device. 
           [0100]      FIGS. 56A through 56C  illustrate a variation of a method for using the device. 
       
    
    
     DETAILED DESCRIPTION 
       [0101]      FIGS. 1A and 1B  illustrate a shell  678 . The shell  678  can have a shell longitudinal axis  26 . The shell  678  can have a shell wall  684  with an average shell thickness  686 . 
         [0102]    The shell  678  can be a tube or a sheath or combinations thereof. 
         [0103]      FIG. 1B  illustrates a cross section A-A of shell  678 . The shell can have a shell proximal stem  30  and/or a shell proximal taper  34  and/or a central section  38  and/or a shell distal taper  42  and/or a shell distal stem. 
         [0104]    The shell  678  can have shell length  28 . Shell length  28  may be the sum of lengths  32 ,  36 ,  40 ,  44  and  45 . The shell  678  can have a shell proximal stem  30  having a shell proximal stem length  32 . The proximal stem length  32  can be from about 3 mm to about 15 mm, more narrowly about 10 mm. The shell  678  can have a shell proximal taper  34  having a shell proximal taper length  36 . The shell proximal taper length  36  can be from about 0 mm to about 25 mm, more narrowly from about 10 mm to about 22 mm, yet more narrowly from about 16 mm to about 20 mm. The shell  678  can have a central section  38  having a central section length  40 . The central section length  40  can be from about 0 mm to about 55 mm, more narrowly from about 30 mm to about 50 mm. The shell  678  can have a shell proximal taper  42  having a shell proximal taper length  44 . The shell proximal taper length  44  can be from about 0 mm to about 25 mm, more narrowly from about 10 mm to about 22 mm, yet more narrowly from about 16 mm to about 20 mm. The shell  678  can have a shell distal stem  43  having a shell proximal stem length  45 . The proximal stem length  45  can be from about 3 mm to about 15 mm, more narrowly about 10 mm. The shell length  28  can be from about 10 mm to about 250 mm, more narrowly from about 50 mm to about 150 mm, still more narrowly about 75 mm to about 125 mm. 
         [0105]    The shell  678  can have a shell central section outer diameter  50 . The central section  38  may have a shell inside radius  706  and a shell outside radius  708 . Diameter  50  may be twice shell outside radius  708 . The central section  38  may be cylindrically shaped, as shown. The shell central section outer diameter  50  can be from about 2 mm mm to about 40 mm, more narrowly about 8 mm to about 30 mm, still more narrowly from about 16 mm to about 28 mm, for example 26, 24, 22 or 20 mm. 
         [0106]    The central section  38  may have a shell outside radius  708 . The shell outside radius  708  can have a maximum dimension at the longitudinal location where the central section  38  meets the tapers  34  or  42 . The shell outside radius  708  can have a minimum dimension in the longitudinal center of the central section  38 . 
         [0107]    The shell  678  can have a shell proximal stem diameter  31 . The shell proximal stem diameter  31  can be from about 0.5 mm to about 8 mm, more narrowly about 1 mm to about 5 mm, for example about 3 mm. The shell  678  can have a shell distal stem diameter  41 . The shell distal stem diameter  41  can be from about 0.5 mm to about 8 mm, more narrowly about 1 mm to about 5 mm, for example about 3 mm. 
         [0108]    The shell  678  can have one or more neck sections adjacent to and extending from the central section  38 . For example, a proximal neck section can be a shell proximal taper  34  extending proximally from the central section  38 . A distal neck section can be a shell distal taper  42  extending distally from the central section  38 . Each of the neck sections can have a neck first end  60  and a neck second end  62 . The neck first end  60  can have identical or different dimensions that the neck second end  62 . The neck first end  60  may be adjacent to the central section  38 . The neck first end  60  can have a neck first end diameter  61 . The neck second end  62  can have a neck second end diameter  63 . The neck first end diameter  61  can be larger than the neck second end diameter  63 . The neck sections can be tapered, conical, multi-splined (e.g., having a plurality of concave and a plurality of convex portions on each neck section), or combinations thereof. 
         [0109]    The shell  678  can have an inner lumen  154 A and an outer lumen  154 B. Inner lumen  154 A may be formed by second hollow shaft  2000 B. Inner lumen  154 A may provide a lumen thru the entire shell. Inner lumen  154 A may allow a guidewire to pass thru the interior of the shell. Outer lumen  154 B may connect to balloon inflation/deflation ports  654 . Outer lumen  154 B may be formed between the inner wall of first hollow shaft  2000 A and the outer wall of second hollow shaft  2000 B. 
         [0110]    The distal taper angle  90 A can be from about 0 to about 90°, more narrowly about 50° to about 20°, yet more narrowly about 45° to about 30°, for example about 35°. The proximal taper angle  90   b  can be from about 0 to about 90°, more narrowly about 50° to about 20°, yet more narrowly about 45° to about 30°, for example about 35°. 
         [0111]    The first hollow shaft  2000   a  can have a hollow shaft distal port  54 . One of the balloon inflation/deflation ports  654  can attach to the hollow shaft distal port  54 . 
         [0112]    The shell  678  can be resilient (i.e., elastic) or non-compliant (i.e., inelastic). 
         [0113]    If shell  678  is configured to be patent and used as a balloon, the shell  678  may have a burst pressure of greater than 3 atm, more narrowly, greater than 10 atm, still more narrowly greater than 15 atm. If shell  678  is configured to be patent and used as a balloon, the shell  678  may have a diametric elasticity of less than 0.35 mm/atm, more narrowly less than 0.2 mm/atm, still more narrowly less than 0.03 mm/atm, still more narrowly less than 0.02 mm/atm. 
         [0114]    The shell wall  684  can have high puncture strength. For example, when a shell  678  is pressurized to about 4 atm and a 1 mm gauge pin is driven into the balloon at about 1 mm/sec, the pin may need to exert more than 13 newtons of force to puncture the balloon wall, more narrowly more than 18 newtons. The shell wall  684  can be non-compliant. The shell wall  684  can have a polymer. The shell wall  684  can be fluid-tight (e.g., non-porous enough to prevent water, and/or saline solution, and/or air transfer or osmosis through the shell wall  684 ). The shell wall  684  can have a wall thickness of about 0.04 mm to about 0.8 mm. 
         [0115]      FIG. 2A  shows a shell  678  with first, second and third shell taper reinforcements  862   a ,  862   b  and  862   c  respectively in the proximal taper  34  and fourth, fifth and sixth shell taper reinforcements  862   d ,  862   e  and  862   f  respectively in the distal taper. Each of the shell taper reinforcements  862  may have different sizes, for instance different lengths. In  FIG. 2A , shell taper reinforcements  862  can be arranged such that a portion of each reinforcement  862  is visible. Shell taper reinforcements  862  may cover part or all of the shell tapers  34  and  42 , stems  30  and  43  and central section  38 . Shell taper reinforcements  862  may have shell taper reinforcement lobes  866 . Shell taper reinforcement lobes  866  may have a semi-circular shape and extend in the shell longitudinal direction, as shown in  FIG. 2A . Shell taper reinforcements  862  may increase the stiffness of the shell wall  684  in areas covered by shell taper reinforcements  862 . For example, either or both the neck sections  34  and/or  42  can have a greater stiffness than the central section  38 . Shell taper reinforcements  862  may be panels  196 . Shell wall  684  may comprise a polymer such as PET, Mylar, Nylon, Pebax, polyurethane or combinations thereof. 
         [0116]      FIG. 2B  shows a shell  678  with shell apertures  714 . Shell apertures  714  may penetrate the entire wall of the shell  678 . Shell apertures  714  may release internal pressure from the shell  678  and may allow materials such as blood or air to cross the plane of the shell wall  684 . The shell apertures  714  can be in fluid communication with the inside and outside of the shell  678 . Shell apertures  714  may be circular, elliptical, rectangular, teardrop shaped, hexagonal or other shapes or combinations thereof. Shell apertures  714  may be located in the shell proximal stem  30 , the proximal taper  34 , the central section  38 , the distal taper  42  or the shell distal stem  43  or combinations thereof. There may be less than 500 apertures  714  in shell  678 , more narrowly less than 100, still more narrowly less than 25. For instance, there may be 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 or 24 apertures  714  in shell  678 . 
         [0117]      FIG. 2C  illustrates that shell  678  may have teardrop shaped shell apertures  714 . Shell apertures  714  may be cut through shell taper reinforcements  862 . The portion of the edge of the shell aperture  714  that extends furthest towards the longitudinal center of the shell  678  may align with the part of the shell taper reinforcement lobe  866  that extends furthest towards the longitudinal center of shell  678  as shown in  FIG. 2C . Thus the aperture  714  can be angularly aligned with lobe  866 . 
         [0118]      FIGS. 3A ,  3 B,  3 C and  3 D illustrate that the shell  678  can have reinforcement fibers  86 . Second or latitudinal reinforcement fibers  86   a  can be perpendicular to the shell longitudinal axis  26 . Fibers  86   a  may be one continuous fiber wound around the part (a “hoop wind”). Fibers may be applied with a certain density. For example, fibers may be applied at 100 winds per 1 inch (25.4 mm). The number of winds per inch is often referred to as the “pitch” of the wind. The pitch can vary across the length of the shell. Fibers  86   a  may be omitted entirely from portions of the shell  678 . 
         [0119]    First or longitudinal reinforcement fibers  86   b  can be parallel with the shell longitudinal axis  26 . Fibers can be applied with a certain density. For instance, there may be 50 fibers  86   b  per 1 inch (25.4 mm) around the circumference of the shell  678 . Fiber  86   b  density can vary around the circumference of the shell. Fibers  86   b  may be omitted entirely from portions of the shell  678 . 
         [0120]    The angle between fibers  86   a  and  86   b  may be approximately perpendicular and may not change between inflation and deflation. 
         [0121]      FIGS. 3A ,  3 B,  3 C and  3 D show that the shell can have a longitudinal proximal zone  618   a , a longitudinal central zone  618   b  and a longitudinal distal zone  618   c . Proximal zone  618   a  may cover the proximal taper  34  and proximal stem  30 . Distal zone  618   c  may cover the distal taper  42  and distal stem  43 . Central zone  618   b  may cover the central section  38 . Fibers  86   a  and/or  86   b  may be present or absent in zones  618   a  and/or  618   b  and/or  618   c . The fiber  86   a  pitch may be different in each of zones  618   a ,  618   b  and  618   c . The fiber  86   a  pitch may vary within each of zones  618   a ,  618   b  and  618   c . The fiber  86   b  density may be different in each of zones  618   a ,  618   b  and  618   c . The fiber  86   b  density may vary within each of zones  618   a ,  618   b  and  618   c.    
         [0122]      FIG. 3A  shows that fibers  86   a  and  86   b  can be present in zone  618   b . Fibers  86   a  and  86   b  may not present in zones  618   a  and  618   c .  FIG. 3B  shows that fibers  86   b  can be present in zones  618   a ,  618   b  and  618   c . Fibers  86   a  may be present only in zone  618   b .  FIG. 3C  shows that fibers  86   b  and  86   a  can present in zones  618   a ,  618   b  and  618   c .  FIG. 3D  shows that the pitch of fibers  86   a  in zone  618   b  may be less than the pitches in zones  618   a  and  618   c . The pitches in zones  618   a  and  618   c  may be substantially equivalent. For example, the pitch in zones  618   a  and  618   c  may be 128 winds per inch, while the pitch in zone  618   b  may be 100 winds per inch. Lower pitch fibers  86  in one zone  618  may cause the shell wall to structurally fail in the lower pitch zone  86  before the pitch zones  86  with a higher fiber pitch. In the example above, zone  618   b  can burst before zones  618   a  and  618   c  when the shell wall  684  experiences structural failure. Zones  618  with lower pitch may be more compliant and foldable than zones  618  with higher pitch. A zone  618  may have a 10% lower pitch than the remainder of the part, more narrowly a 20% lower pitch than the remainder of the shell wall  684 . 
         [0123]    The boundaries between zones  618   a  and  618   b  and between  618   b  and  618   c  may move. For instance, the boundaries may be located in the shell tapers  34  or  42  or the central section  38 . Second or latitudinal reinforcement fibers  86   a  may or may not be a continuously wound single fiber. 
         [0124]      FIG. 4  illustrates that first reinforcement fiber  85   a  can be at a first reinforcement fiber angle with respect to the shell longitudinal axis  26 . For instance, the first reinforcement fiber angle can be 10, 15, 20, 25, 50, 55 or 60 degrees to the shell longitudinal axis. Second reinforcement fiber  85   b  can be at a second reinforcement fiber angle with respect to the shell longitudinal axis  26 . For instance, the second reinforcement fiber angle can be 10, 15, 20, 25, 50, 55 or 60 degrees to the shell longitudinal axis. Second reinforcement fiber  85   b  can have an equal but opposite angle to first reinforcement fiber  85   a . For example, first reinforcement fiber  85   a  can be at +20 degrees and second reinforcement fiber  85   b  can be at −20 degrees to the shell longitudinal axis. Third reinforcement fiber  85   c  can be substantially perpendicular to the shell longitudinal axis. Third reinforcement fiber  85   c  may be omitted from the shell wall  684 . 
         [0125]      FIG. 5  illustrates longitudinal reinforcement fiber  86   b  can be parallel with the shell longitudinal axis  26 . Second longitudinal reinforcement fiber  87   b  can be parallel with the shell longitudinal axis  26 . Fibers  86   b  and  87   b  can be separated by areas of missing longitudinal fiber  614 . Areas  614  may separate fibers  86   b  and  87   b  by 2 mm, more narrowly less than 1 mm, still more narrowly less than 0.25 mm. Areas  614  may be distributed on the shell surface such that no area longitudinally substantially overlaps any other area on the shell. Areas  614  may be distributed such that latitudinally adjacent areas do not have any longitudinal overlap. Areas  614  may be distributed in a regular, repeating pattern around the diameter of the shell sufficient to prevent any fiber from reaching from one end of the shell to the other while still maximizing the longitudinal strength of the shell. Fibers  86 B and  87 B may be less than 80% as long as the shell, more narrowly less than 75%, still more narrowly less than 70%, still more narrowly less than 65%, still more narrowly less than 60%. Second or latitudinal reinforcement fibers  86   a  can be substantially perpendicular to the shell longitudinal axis  26 . 
         [0126]      FIG. 6  illustrates that the longitudinal reinforcement fiber  86   b  can be parallel with the shell longitudinal axis  26 . Second longitudinal reinforcement fiber  87   b  can be parallel with the shell longitudinal axis  26 . Fibers  86   b  and  87   b  can overlap in reinforcement fiber overlap area  612 . Reinforcement fiber overlap area  612  may form a hoop shaped area that can completely encircle the central section  38 . 
         [0127]      FIG. 7A  illustrates that a shell  678  can be pleated to form flutes  84 , for example four, five, six, seven or eight flutes  84 , such as first flute  84   a , second flute  84   b . The flutes  84  can be made from accordion pleats, box pleats, cartridge pleats, fluted pleats, honeycomb pleats, knife pleats, rolled pleats, or combinations thereof. The pleating can be heat and/or pressure formed and/or the reinforcement fibers and/or panels can be oriented to form the flutes  84 . Pleating the shell  678  may create first inner pleat line  822   a  and second inner pleat line  822   b  and outer pleat lines  826   a  between inner pleat lines  822   a  and  822   b . Pleat lines  822  and  826  may be areas where the shell wall  684  can be creased. Inner pleat lines  822  may be positioned radially inward from outer pleat lines  826  when the shell is collapsed as shown in  FIG. 7A . Each flute  84  can be the portion of the shell wall  684  between two inner pleat lines  822 . The shell apertures  714  can be between adjacent outer pleat lines  826  and interrupt an inner pleat line  822  as shown. The apertures  714  may or may not cross an inner pleat line  822 . The apertures  714  may or may not cross an outer pleat line  826 . 
         [0128]      FIG. 7B  illustrates a section view at D-D of  FIG. 7A . The portion of the section view that shows aperture  714  is highlighted with a dotted line. The width of aperture  714  at section D-D can be divided into aperture first partial width  830  and aperture second partial width  834 . Aperture first partial width  830  may be about the same as aperture second partial width  834 . For example, the aperture  714  can be centered on the inner pleat line  822 . The aperture first partial width  830  may be different than width  834 , for instance equal to one to three times width  834 , thus placing aperture  714  off center from inner pleat line  822 . Aperture  714  can be wholly between two adjacent outer pleat lines  826 , for instance between outer pleat lines  826   a  and  826   b.    
         [0129]      FIG. 7C  illustrates a section view at E-E of  FIG. 7A . The central zone of the shell can have apertures or no apertures (as shown) interrupting the shell wall  684 , as shown at section E-E. 
         [0130]      FIG. 7D  illustrates that the pleated shell  678  or annular balloon structure  682  can be collapsed into a compact form with a reduced diameter. Pleating may allow the shell  678  or structure  682  to collapse and expand in a repeatable and regular way. In this collapsed state, apertures  714  may be wholly (as shown) or partially covered or concealed by collapsed flutes  84 , for instance second flute  84   b  may cover or conceal aperture  714 . Covering the apertures  714  may give the collapsed shell  678  or annular balloon  682  an outer surface free of interruptions from the apertures  714 . The diameter of the structure can be minimized and the apertures can be covered by the structure surface before and during insertion of the structure into the body during a medical procedure. 
         [0131]    Annular balloon structure  682  may be subjected to a first cycle and a second cycle of inflation and deflation. Annular balloon structure  682  may have the same number of pleats after first and second cycles of inflation and deflation. For example, the fold position angle of the pleats, and the number and location of the pleats can remain about constant after an inflation and deflation cycle. 
         [0132]    A material, such as a gas or a liquid, may flow from the shell exterior  49  through shell apertures  714  on one taper of the shell (for instance, the distal taper  42 ), pass through the shell interior  47  and flow out of shell apertures  714  on the other taper of the shell (for instance, the proximal taper  34 ) to the shell exterior  49 .  FIG. 8  shows that apertures  714  may be fitted with shell aperture unidirectional flow valves or flaps  718 , for instance apertures  714  may be fitted with shell aperture flaps  718  on proximal taper  34 . Shell aperture flaps  718  may be configured so that they will partially or completely cover apertures  714  when there is no material flowing through the shell interior  47  to the proximal end, for example, of the shell exterior  49 . When material is urged to flow with sufficient pressure from the shell interior  47  to the shell exterior  49 , flaps  718  may open to allow flow through apertures  714 . When pressure is reduced or removed, flaps  718  may partially or completely cover apertures  714 . Flaps  718  may act as one-way or two-way valves. For example, flow and flow pressure (e.g., of a body fluid such as blood) through the apertures  714  may be generated by a beating heart during a medical procedure. Flaps  718  may be a temporary or permanent replacement for a heart valve (such as the aortic valve) during a medical procedure. Flaps may be made of a polymer film or be made similar to the shell wall  684  described herein or be made of a compliant material such as, for instance, an elastomer. The flap may be made integral to the shell by cutting the aperture  714  but omitting the circumferential cut, for example leaving a hinge  719 . 
         [0133]      FIG. 9A  shows a pattern for a marker wire  190 . Marker wire  190  may be wound around the shell  678 . The marker wire  190  can partially cover the distal and proximal ends of the central section  38  of the shell  678 . 
         [0134]      FIG. 9B  shows that marker wire  190  may be wound around the shell on both the distal  42  and proximal tapers  34  of the shell  678 . The marker wire  190  may be wound up to the distal and proximal borders of the central section  38  without any substantial amount of the wire being placed in the central section  38 . The marker wire may be wound in a helical pattern in both directions on the shell or be wound in a single direction. The marker wire crossing angle  191  between two layers of marker wire may be less than 20 degrees, more narrowly less than 10 degrees, still more narrowly less than 6 degrees. 
         [0135]      FIG. 9C  illustrates that the shell  678  can have a marker wire  190  wrapped over approximately the entire length of central section  38 . The marker wire  190  may be centered on the central section  38 . The marker wire  190  may cover only a portion of the central section  38 . For instance, the marker wire  190  may cover more than 70% of the central section  38 , more narrowly more than 80%, still more narrowly more than 90%. The marker wire  190  may cover a portion of the distal tapers  42  and proximal tapers  34 . For example, the marker wire  190  may cover 100% of the distal tapers  42  and proximal tapers  34 , more narrowly more than 50%, still more narrowly more than 25%. The marker wire  190  may be a latitudinal reinforcement fiber  86   a.    
         [0136]      FIG. 9D  illustrates that the shell  678  can have a marker wire  190  wrapped over substantially the whole length of the shell  678 . 
         [0137]    The pitch of the marker wire  190  may be less than about 150 winds per 1 inch (25.4 mm), more narrowly less than about 75 winds per 1 inch (25.4 mm), still more narrowly less than about 25 winds per 1 inch (25.4 mm), still more narrowly less than about 10 winds per 1 inch (25.4 mm). The pitch of the marker wire  190  may be about 6, 5, 4, 3 or 2 winds per 1 inch (25.4 mm). 
         [0138]      FIG. 10A  illustrates that the shell wall  684  at section B-B or at other sections taken through a single wall of the shell can have a layer  72  that can have a fiber matrix. The fiber matrix can have one or more monofilaments  274  and one or more adhesives  208 . The adhesive can remain flexible when cured or melted to form an annular balloon structure  682 . A fiber matrix may comprise a layer  72  or a panel  196 . 
         [0139]    The reinforcement fiber  85 ,  86  and  87  can be a monofilament  274  and/or a tow  270 . A tow  270  may contain one or more monofilaments  274 . Reinforcement fiber  86  can be a marker wire  190 . A fiber matrix may have one, two or more reinforcement fibers  86  running substantially parallel to each other and embedded in an adhesive  208 . The substantially parallel reinforcement fibers  86  may be positioned within the adhesive such that they are touching each other along their length. The substantially parallel reinforcement fibers  86  may be positioned such that there is adhesive separating each fiber along its length. 
         [0140]      FIG. 10A  illustrates a layer  72  with a fiber matrix having a layer width  210  in cross-section. The layer width  210  can include a number of monofilaments  274 . The layer  72  can have a linear quantity fiber density measured, for example, as the number of fibers  86  per unit of layer width  210 . The linear quantity fiber density can be equal to or greater than about 500 monofilaments  274  per inch, more narrowly equal to or greater than about 1000 monofilaments  274  per inch, more narrowly equal to or greater than about 2000 monofilaments  274  per inch, yet more narrowly equal to or greater than about 4000 monofilaments  274  per inch. For example, the liner quantity monofilaments  274  density can be from about 1,000 monofilaments  274  per inch to about 2,000 monofilaments  274  per inch. 
         [0141]    The layer  72  with a fiber matrix can have a layer thickness  216  from about 1 μm (0.00004 in.) to about 50 μm (0.002 in.), more narrowly from about 8 μm (0.0003 in.) to about 25 μm (0.001 in.), yet more narrowly from about 10 μm (0.0004 in.) to about 20 μm (0.0008 in.). Monofilaments  274  or fibers  86  may have a non-circular cross section, for instance an oval cross-section. 
         [0142]    Part or all of the shell wall  684  can have a volumetric quantitative density of monofilaments  274  measured, for example, as the number of monofilaments  274  per unit of area. The area quantity monofilaments  274  density can be equal to or greater than about 100,000 monofilaments  274  per square inch, more narrowly equal to or greater than about 250,000 monofilaments  274  per square inch, more narrowly equal to or greater than about 1,000,000 monofilaments  274  per square inch, yet more narrowly equal to or greater than about 4,000,000 monofilaments  274  per square inch. The area quantity of fiber can be about 25% of the area of a wall cross section, more narrowly about 50%, more narrowly about 75%. 
         [0143]    The ratio of the volume of a fiber matrix to the volume of the monofilaments  274  can be about equal to or greater than about 15%, more narrowly equal to or greater than about 30%, more narrowly equal to or greater than about 50%, yet more narrowly equal to or greater than about 75%. 
         [0144]      FIG. 10B  illustrates that the outer layer  72   a  and the inner layer  72   b  can be polymer films, for example as described infra. In any variation, the polymer films can be the same or different polymers, or any combination thereof. The first middle layer  72   c  can have a fiber matrix, for example with the fibers oriented as longitudinal fibers  86   b . The second middle layer  72   d  can have a fiber matrix, for example with the fibers oriented as latitudinal or hoop fibers  86   a . The third middle layer  72   e  can be an adhesive. The fourth middle layer  72   f  can be a radiopaque layer, such as a metal foil or wire. 
         [0145]      FIG. 11A  is a cross section taken at C-C in  FIG. 3C .  FIG. 11A  illustrates that the outer layer  72   a  and the inner layer  72   b  can be polymer films, for example as described infra. The first middle layer  72   c  can have a fiber matrix, for example with the fibers oriented as longitudinal fibers  86   b . The second middle layer  72   d  can have a fiber matrix, for example with the fibers oriented as latitudinal or hoop fibers  86   a . The third middle layer  72   e , the fourth middle layer  72   f  and the fifth middle layer  72   g  can be shell taper reinforcements  862 . Shell taper reinforcements may be of unequal longitudinal lengths as shown in  FIG. 11A . An adhesive may be placed between any of the layers  72  shown. Any of the layers  72  shown in  FIG. 11A  may be omitted. 
         [0146]    As shown in  FIG. 11A , proximal taper  34  or distal taper  42  may have a first wall average shell thickness  686   a . Central section  38  may a second wall average shell thickness  686   b . First wall average thickness  686   a  may be greater than second wall average thickness  686   b.    
         [0147]    The shell wall  684  of the proximal taper  34  and/or distal taper  42  can be the same or more stiff per unit of area than the shell wall  684  of the central section  36 . For example, the shell wall  684  of the proximal taper  34  and/or distal taper  42  can have a measured bending stiffness of about two, about three, or about five times greater per unit of area than the shell wall  684  of the central section  36 . 
         [0148]      FIG. 11B  is a cross section taken at C-C in  FIG. 3C .  FIG. 11A  illustrates that shell taper reinforcements  862  may be placed nearer to inner layer  72   b  than outer layer  72   a.    
         [0149]    A layer  72  can be a panel  196 . Layers  72  and/or panels  196  may comprise a polymer. The polymer may be a film. The thickness of the polymer films can be from about 2 μm to about 50 μm, more narrowly from about 2 μm to about 18 μm, yet more narrowly from about 4 μm to about 12 μm. Films may be metalized or coated to change their surface properties. Metallization or coating may take place before or after a film is formed. Films may be treated chemically or via plasma or via corona treating or by combinations thereof in order to modify their bondability. A layer  72  and/or a panel  196  and/or a film may comprise polyamide, co-polyamide, polyester, co-polyester, ECTFE, Solef, EPTFE, FEP, Kapton, Pebax, HDPE, LDPE, PET, Mylar, micrton, nylon, PEEK, PEN (polyethylene Napthalate), Tedlar, PVF, Polyurethane, Thermoplastic Polyurenthane (TPU), Parylene or combinations thereof. 
         [0150]    The reinforcement fibers  86  can be high strength and inelastic. Inelastic fibers may have a strain to failure of less than 10%, more narrowly less than 5%. High strength fibers may have an ultimate tensile strength greater than 1.8 GPa (260 ksi), more narrowly greater than 2.4 GPa (350 ksi), still more narrowly greater than 2.9 GPa (420 ksi). 
         [0151]    The reinforcement fibers  86  can have a fiber or monofilament diameter  212 , for example, from about 1 μm to about 50 μm, for example less than about 25 μm, more narrowly less than about 20 μm. 
         [0152]    The reinforcement fibers  86  may be a wire or wires. The reinforcement fibers  86  may be a metal. Wire may have a strain to failure of less than 10%, more narrowly less than 5%, still more narrowly less than 2%. The wire may be annealed or tempered to adjust its mechanical properties. The wire may have a breaking strength of greater than 150KSI, more narrowly greater than 250KSI, more narrowly greater than 400KSI 
         [0153]    Wire may be ductile and have a strain to failure of greater than 20%, more narrowly greater than 40%, still more narrowly greater than 80%. Ductile wire may allow the shell  678  the fold without fracturing the wire. 
         [0154]    The wire may be less than 25 um in diameter. The wire may be substantially rectangular and less than 25 um in thickness  1068 , more narrowly less than 15 um in thickness  1068  when integrated into the wall of the balloon. The ratio of the width  1072  of the wire to the thickness  1069  of the wire may be greater than or equal to about 3, more narrowly greater than or equal to about 5, more narrowly greater than or equal to about 10. The wire may be a foil wherein the ratio of the width  1072  of the wire to the thickness  1069  of the wire may be greater than or equal to about 100, more narrowly greater than or equal to about 300, more narrowly greater than or equal to about 500. The density of the wire may be greater than about 2.4 g/cm̂3, more narrowly greater than about 6.9 g/cm̂3, more narrowly greater than about 15 g/cm̂3. 
         [0155]    The reinforcement fiber  86  or wire may be substantially radiopaque when used under a flourosocpe as part of a medical procedure in the human body. The use of radiopaque material, such as radiopaque fibers  86 , may allow the physician to use an inflation medium, such as saline, which is not radiopaque when inflating a balloon  650  or annular balloon structure  682 . The use of radiopaque material, such as radiopaque fibers  86  may allow the physician to visualize how well pleated or folded the balloon structure  682  is when placed in the human body. The fibers  86  may be substantially radiolucent. A fiber matrix can have the same or different sizes and materials of fibers  86  within the same fiber matrix. 
         [0156]    The reinforcement fibers  86  or wires may be coated. The coating may enhance adhesion. The coating may be an adhesive  208 . The adhesive  208  may be melted as part of the process of applying reinforcement fibers  86  to a shell  678 . 
         [0157]    A reinforcement fiber  86  may comprise Vectran, PBO (p-phenylene-2,6-benzobisoxazole), Zylon, Spectra, Dyneema, UHMWPE, Conex, Technora, Twaron, Dacron, Polyester, Compet, Nylon, PEEK, PPS, Boron, Cermic, Kevlar, aramid, Carbon, Carbon Fiber, Inorganic Silicon, glass, fiberglass, Tungsten and its alloys, Tantalum and its alloys, Molybdenum and its alloys, bismuth and its alloys, gold and its alloys, silver and its alloys, platinum and its alloys, iridium and its alloys, stainless steel (for instance, alloys 302, 304, 316, 440), Nickel and its alloys, cobalt and its alloys, Titanium and its alloys, copper and its alloys, Barium and its alloys, bismuth and its alloys, Iodine and its alloys, Nitinol alloys or combinations thereof. 
         [0158]    Adhesive  208  can be an thermoset material, a thermoplastic material, or a combination thereof. Adhesive  208  can be elastomeric. Adhesive  208  can be a polymer or a monomer or combinations thereof. The adhesive  208  can be a urethane, a polyurethane, a thermoplastic polyurethane (TPU), a thermoplastic, a cyanoacrylate, a UV curing adhesive, a polyester, a nylon, a polyamide, a silicone, a polypropylene, a polyolefin, ULDPE, VLPDE, LDPE, an epoxy, a pebax, Tefzel, an EVA, Solef, a parylene or combinations thereof. The adhesive  208  can be a resin or a glue. 
         [0159]    Any of layers  72  or panels  196  can be leak proof, water tight, air tight, MMA (Methyl methacrylate)-resistant, MMA-releasing, or combinations thereof. 
         [0160]    Magnetic resonance visualization enhancement materials, such as magnetic contrast agents, can be added to the adhesive  208  or any layer  72  or panel  196 . The magnetic resonance visualization enhancement materials can enhance the visualization of the balloon during an magnetic resonance imaging (MRI) procedure. For example, the magnetic resonance visualization enhancement material can be gadolium, Omniscan, Optimark, ProHance, Magnevist, Multihance, or combinations thereof. 
         [0161]    Any of the layers  72 , for example the outer layer  72   a , can be tinted or dyed a visible spectrum color. For example, a pigment, coloring additive, dispersions or other coloring agents, such as a coloring additive from Plasticolors (Ashtabula, Ohio) can be added. A paint or coating can be added to the outer surface of the shell  678 . 
         [0162]    The color can be selected for branding, market differentiating, as an indication of the type of device, the size of the device, or combinations thereof. For example, devices having a selected diameter, length, pressure rating, clinical indication or efficacy, other common performance metric, or combinations thereof, can be dyed a specific color (e.g., green for a first type of device, red for a second type of device). 
         [0163]    The layers  72  can have one or more optical fibers. The fiber optic can be a strain sensor. The strain sensor can monitor mechanical status in real time. The fiber optic can guide light delivery into the body. The fiber optic can visualize a target site (e.g., gather light from the body to produce a visual image). 
         [0164]      FIG. 12  shows that a balloon  650  can have a balloon main diameter  662 , a balloon length  666  and a balloon wall thickness  658 . The balloon may have a balloon taper section  652  at either end. The taper sections may connect the balloon diameter to the balloon inflation/deflation ports  654 . The balloon  650  may be inflated by putting a pressurized fluid, such as saline, contrast, water or a gas, into both inflation/deflation ports or by putting fluid into one of the inflation/deflation ports  654  while closing the other inflation/deflation ports  654 . 
         [0165]    Balloon  650  may have a main diameter  662  of about 1 mm to about 15.3 mm, more narrowly about 4 mm to about 12 mm, still more narrowly about 6 mm to about 10 mm. The balloon wall thickness  658  may be about 5 μm to about 50 μm, more narrowly about 8 μm to about 25 μm, still more narrowly about 8 μm to about 15 μm. The balloon length  666  may be about 125 mm to about 635 mm, more narrowly about 200 mm to about 500 mm, still more narrowly about 250 mm to about 380 mm. 
         [0166]      FIG. 13  shows that balloon  650  can have balloon segments  656   a - 656   f . Balloon segments  656   a - 656   f  may form a continuous internal inflation/deflation lumen. Each balloon segment  656  may be joined by a balloon flexion section  670   a - 670   e  to the adjacent balloon segment  656 . The balloon flexion sections  670  may have a smaller balloon flexion section diameter  664  than the balloon main diameter  662  (i.e., of the balloon segments  656 ). Balloon  650  may have a balloon flexion section diameter  664  of about 1 mm to about 10 mm, more narrowly about 2 mm to about 6 mm, still more narrowly about 2.5 mm to about 5 mm. Balloon  650  may have a balloon flexion section diameter  664  of about 3.3 mm. Multi-segment balloon taper section  653  can connect the balloon flexion sections  670  to the balloon segments  656 . The balloon  650  can bend or flex at the balloon flexion sections  670  before bending at the balloon segments  656 , for example, when the balloon  650  is inflated. The balloon  650  could have 4, 5, 6, 7, 8, 9, 10 or more balloon segments  656 . 
         [0167]    The balloon  650  may be made of one polymer, or use several layers or a mix of different polymers. Polymers such as Nylon, PEBAX, PET, parylene and/or polyurethane may be used to make the balloon  650 . The balloon  650  may be fabricated by blow molding. The balloon may comprise a layer  72 , a panel  196  or a film as described supra. 
         [0168]    Heat shrink tubing may be used to form the balloon  650 . For instance, the balloon  650  could be formed by placing heat shrink tubing over a removable mandrel, heating the tubing and then removing the mandrel. The mandrel may be removed mechanically, with a solvent such as water, by the application of heat, or combinations thereof. 
         [0169]    The balloon  650  may be formed by depositing a material either onto a mandrel or into a cavity mold. The mandrel may be removed as described above or a mold may be opened to remove the balloon  650 . Deposition could be by various techniques of physical vapor deposition, dipping, coating or spraying. Parylene may be deposited using a physical vapor deposition process. The balloon  650  may be deposited directly onto a mandrel with the shape shown in  FIGS. 15 ,  16 ,  17  and  18 . The mandrel could then be removed. 
         [0170]    The balloon may comprise a fiber and be designed and fabricated as described in U.S. Provisional Application No. 61/363,793, filed 13 Jul. 2010, and in PCT Application No. PCT/US2011/43925, filed Jul. 13, 2011, both of which are incorporated by reference herein in their entireties. 
         [0171]      FIG. 14A  shows a balloon with balloon restraints  674  wrapped around the length of balloon  650 .  FIG. 14B  shows a balloon with balloon restraints  674  wrapped around the portions of the length of the balloon. The balloon restraints  674  may be bonded to the outside of the balloon. The restraints  674  may be knotted or tied around the balloon. The balloon restraints  674  may serve to narrow and bunch the balloon at the point they are applied, thus creating a balloon flexion section  670 . A balloon flexion section  670  could also be created by locally twisting the balloon. 
         [0172]      FIGS. 15 and 16  show a balloon  650  after balloon segments  656  have been formed into an annular balloon structure  682  and inflated. The balloon segments can form a ring with a clear or hollow passageway or channel in the center. The annular balloon structure working length  680  can be the about equal to the longitudinal length of the largest diameter constant diameter section of each balloon segment  656 . Working length  680  may be about 12 mm to about 100 mm, more narrowly about 25 mm to about 75 mm, still more narrowly 32 mm to 65 mm. Working length  680  may be about 45 mm. The balloon segments  656  may be attached to each other with adhesive, solvent, the application of heat or combinations thereof.  FIG. 15  shows that the local balloon diameter of the flexed or relaxed (i.e., unfllexed) flexion section  670  can be less than the main balloon diameter of the balloon segments  656 .  FIG. 16  shows a flexion section  670  where the balloon has been bent or folded with no previous narrowing of the balloon diameter. The balloon may be inflated by putting pressure into balloon inflation/deflations ports  654   a  and  654   b . The inflation/deflation ports  654   a  and  654   b  may be joined into a single inflation/deflation port. 
         [0173]    First balloon segment  656   a  may have a first balloon segment longitudinal axis  657   a . Second balloon segment  656   b  may have a second balloon segment longitudinal axis  657   b . Balloon segment longitudinal axis angle  659  may be the angle between first balloon segment longitudinal axis  657   a  and second balloon segment longitudinal axis  657   b . Balloon segment longitudinal axis angle  659  may be zero degrees to 200 degrees, more narrowly, 160 degrees to 200 degrees, for example 180 degrees. The longitudinal axis angle  659  can be the angle formed by the opposite terminal ends of the balloon flexion section  670  adjacent to the respective balloon segments  656 . 
         [0174]      FIG. 17  shows a group of inflated balloons  650  arranged into an annular balloon structure  682 . Rather than sharing an inflation/deflation lumen, each balloon has two inflation/deflation ports  654 .  FIG. 18  shows a balloon design with one inflation/deflation port and the other end closed. The balloon in 8B could be arranged into an annular balloon structure  682  similar to that shown in  FIGS. 15 ,  16  and  17 . Balloons  650  may have their interior volumes connected together by piercing or punching holes in the wall of each balloon and then aligning the holes in each balloon before bonding the balloons  650  together. 
         [0175]      FIG. 19  shows one method of forming the balloon  650  into an annulus. Adhesive  208  or a solvent may be applied to the outside of the balloon. The balloon  650  may be threaded around pins  676 . The balloon flexion section  670  may be twisted about the balloon longitudinal axis, for instance 45 or 90 degrees. A compression fixture, for instance a balloon assembly fixture compression sleeve  898  (e.g., a non-stick tube such as one made out of fluorinated ethylene propylene (FEP), such as Teflon) may be slid over the balloon  650  in order to hold and radially compress the balloon segments  656  together. The balloon assembly fixture compression sleeve  898  may have an inside diameter smaller than the outside diameter of the annular balloon structure  682  shown in, for instance,  FIG. 15 ,  16  or  17 . A cross section of balloon  650  in balloon assembly fixture compression sleeve  898  may look similar to  FIG. 24B  with shell  678  being replaced by balloon assembly fixture compression sleeve  898 . Heat may be applied to cure the adhesive  208  or to melt and fuse the segments  656  together. 
         [0176]      FIG. 20A  shows a balloon  650  after having been formed into a spiral to make an inflated annular balloon structure  682 . That is, the balloon  650  forms a spiral ring with a central fluid passage  692  in the center. The coils of the spiral may be attached to each other with adhesive, solvent, the application of heat or combinations thereof. The balloon may be inflated by putting pressure into balloon inflation/deflations port  654 . Multiple spiral coils may be interleaved to form one annular balloon structure. 
         [0177]      FIGS. 20B and 20C  shows a spiral forming tool  742 . The spiral forming tool has a spiral groove  746 . A nominally straight balloon  650  may be wrapped around the spiral groove and pressurized. The pressurized assembly may be placed in the oven. The balloon dimensions may gradually creep until the balloon has been formed into the spiral shown in  11   a.    
         [0178]      FIG. 21  shows that the balloons  650  can have toroidal configurations. The balloons  650  can be stacked to make an annular balloon structure  682 . The balloons  650  can form a ring with a clear passageway in the center. The balloons  650  may be attached to each other with adhesive, solvent, the application of heat or combinations thereof. The balloons  650  may be inflated by putting pressure into the balloon inflation/deflations port  654  (not shown). The lumens of each balloon  650  may be in fluid communication with one or more (e.g., all) of the other lumens and connected to one or more (e.g., all) of the other lumens internally. 
         [0179]      FIGS. 22A and 22B  show the balloon  650  can be attached to a balloon strap  672 . The balloon  650  can be in a spiral configuration. The balloon strap  672  may be removed during a medical procedure such that the balloon  650  may unwind along the first hollow shaft  2000   a . This may make it easier to extract the balloon  650  thru an introducer after a procedure. 
         [0180]    An annular balloon structure may comprise a balloon  650  and a shell  678 . 
         [0181]      FIG. 23A  shows that the inflated annular balloon structure can have a shell  678 . The shell  678  may wrap, encircle or enclose the balloon segments  656 . The shell  678  may entirely or partially (as shown) cover the balloon segments  656 . 
         [0182]      FIG. 23B  shows a cross section F-F thru the center of the inflated annular balloon structure  682  in  FIG. 23A . The annular balloon structure  682  can have a central fluid passage  692  that may allow the annular balloon structure  682  to perfuse when used in a lumen in the body. The annular balloon structure  682  can have an inside radius  690 . This inside radius  690  can be ½ the maximum circular diameter that can pass through central fluid passage  692  of the annular balloon structure  682 . For example, the inside radius might be from about 2.5 mm to about 10 mm, more narrowly from about 5 mm to about 7.5 mm. The inside radius may be about 6.4 mm. 
         [0183]      FIGS. 23B and 24B  illustrate that the annular balloon structure  682  may have a first balloon cell  691   a  and a second balloon cell  691   b .  FIGS. 23B and 24B  show a total of 8 balloon cells  691 . Balloon cells  691   a  and  691   b  may be joined by balloon contact line  710 . Similar balloon contact lines may exist between adjacent balloon cells  691  in  FIGS. 23B and 24B . The annular balloon structure  682  may have a balloon contact inner radius  694  and a balloon contact outer radius  698 . These radii are aligned with the innermost and outermost extent of the contact between balloon cells  691   a  and  691   b . The difference between the inner and outer contact radii can be about zero. For example the balloon cells  691   a  and  691   b  can be touching only at a point of tangency. The balloon contact inner radius and outer radius may be about 3.8 mm to about 15 mm, more narrowly about 7.5 mm to about 11.5 mm. The balloon contact inner radius and outer radius may be about 9.5. 
         [0184]    The balloon radius  704  can be the radius of the circle intersecting all of the center axes of each balloon cell  691 . The balloon radius  704  may be about 5 mm to about 15 mm more narrowly about 5 mm to about 13 mm. The balloon radius  704  may be about 10 mm. The shell wall  684  may have a shell average thickness  686  of about 7 μm to about 65 μm, more narrowly about 13 μm to about 38 μm, still more narrowly about 20 μm to about 30 μm. The shell outside radius  708  may be the shell inside radius  706  plus the shell thickness. The shell outside radius  708  may be equal to one half of the shell central section outer diameter  50 . 
         [0185]    The balloon radius  702  may be about 0.5 mm to about 7.6 mm, more narrowly about 2 mm to about 5.8 mm, still more narrowly about 3 mm to about 5 mm. The balloon radius  702  may be about 3.8 mm. 
         [0186]    The balloon cells  691  may have about zero contact with each other and with the inside of the shell  678  (as shown in  FIG. 23B  at shell contact line  712 ). The leakage area  700  between the inner wall of the shell and the balloon contacts  710  may be 12-22% of the total area enclosed by the shell cross section, more narrowly about 17%. The leakage area may be greater than 10%, more narrowly greater than 15%. 
         [0187]      FIG. 24A  shows an inflated annular balloon structure  682  with a shell  678 . The shell  678  may entirely or partially (as shown) cover the balloon segments  656 . The balloon  650  shown in  FIG. 24A  may have similar or identical dimensions to the balloon  650  shown in  FIG. 23A . The shell  678  shown in  FIG. 24A  may have a smaller shell outside radius  708  than the shell  678  shown in  FIG. 23A . The shell  678  in  FIG. 24A  may be placed over the balloon segments  656 . The shell may compress or squeeze balloon segments  656  such that the balloon segments  656  may be deformed and driven closer to the shell longitudinal axis  26 . The shell  678  may be in tension when the balloon segments  656  are inflated 
         [0188]      FIG. 24B  shows a cross section G-G thru the center of the inflated annular balloon structure  682  in  FIG. 24A . The annular balloon structure can have a central fluid passage  692 . The central fluid passage  692  can be an open channel along the entire length of the inflated annular balloon structure  682 . The central fluid passage  692  may fluidly connect to apertures  714  in proximal taper  34  and distal taper  42 . When the annular balloon structure  682  is placed in a body lumen, for example in the vasculature, fluid (such as blood) or gas (such as air) in the lumen can flow through the central fluid passage  692 . For example, the balloon can perfuse when in the vasculature or in an airway. 
         [0189]    The annular balloon structure may have a second hollow shaft  2000   b  in the central fluid passage  692 . There may be a flow area gap  693  between the second hollow shaft  2000   b  and the balloon  650 . The flow area gap  693  might be from about 2 mm to about 10 mm, more narrowly from about 4 mm to about 7 mm, for example 5.5 mm. Second hollow shaft  2000   b  is not shown in  FIGS. 23A ,  23 B and  24 A. 
         [0190]    The inside radius  690  of annular balloon structure  682  shown in  FIG. 24B  may be, for example, about 2.5 mm to about 10 mm, more narrowly about 3 mm to about 5.6 mm, for example about 4.3 mm. The area of the circle defined by the inside radius  690  may be about 0.091 inches squared or about 0.59 centimeters squared. 
         [0191]    The balloon cells  691   a  and  691   b  may be joined by balloon contact line  710 , for example with a bond. The annular balloon structure  682  may have a balloon contact inner radius  694  and a balloon contact outer radius  698 . These radii are aligned with the innermost and outermost extent of the balloon contact  710  between balloon cells  691   a  and  691   b . The balloon contact inner radius  694  may about 1 mm to about 20 mm, more narrowly 2.5 mm to about 13 mm, more narrowly about 5 mm to about 7.5 mm. The balloon contact inner radius may be about 6.4 mm. The balloon contact outer radius  698  may be about 2 mm to about 20 mm, more narrowly 5 mm to about 15 mm, more narrowly about 7.6 mm to about 12.7 mm. The balloon contact outer radius may be about 10 mm. Balloon contact line  710  can have a contact length about equal to the inner radius subtracted from the outer radius 
         [0192]    The balloon cell perimeter  696  is about equal to the total length of the dotted line  696  shown in  FIGS. 23B and 24B  (the dotted line matches the wall of the balloon cell  691 ). Balloon cells  691  may have a balloon cell perimeter  696  of about 3 mm to about 48 mm, more narrowly about 12.7 mm to about 37 mm, still more narrowly about 19 mm to about 32 mm, for example about 24 mm. 
         [0193]    The length of the balloon contact line  710  may be greater than about 5% of the balloon cell perimeter  696 , more narrowly greater than about 10%, still more narrowly greater than about 12%, for example about 16%. 
         [0194]    The balloon outer radius  702   a  may be about 0 mm to about 5 mm, more narrowly about 0.5 mm to about 3 mm, still more narrowly about 1 mm to about 2.5 mm, for example about 1.5 mm. The balloon inner radius  702   b  may be about 0.5 mm to about 7.5 mm, more narrowly about 1 mm to about 5 mm, still more narrowly about 1.5 mm to about 3.8 mm, for example about 2.5 mm. 
         [0195]    The leakage area  700  between the inner wall of the shell  678  and the balloon contact line  710  may be less than about 15% of the total area enclosed by the shell cross section, more narrowly less than about 10%, still more narrowly less than about 5%, for example 2%. 
         [0196]    The leakage area  700  can be sealed (no fluid communication) from central fluid passage  692 . The leakage area  700  can be connected to a pressure source accessible by the physician. Leakage area  700  may contain a fluid, for instance, a drug. Shell wall  684  may have pores, for instance holes less than 0.005 mm in diameter. Shell wall  684  may perfuse from shell interior  47  to shell exterior  49 . Pressurizing the fluid in leakage area  700  may cause the fluid in area  700  to travel from shell interior  47  to shell exterior  49 . 
         [0197]    The arc length of the shell contact line  712  may be about 1.3 mm to about 10 mm, more narrowly about 3.3 mm to about 8.4 mm, still more narrowly about 4 mm to about 7.5 mm, for example about 5.8 mm. 
         [0198]      FIG. 24   b  illustrates that the balloon cells  691  at the shell contact line  712  can be concentric with the shell  678 , for example with the shell inner perimeter. The length of the wall of the balloon cells  691  at the shell contract line  712  can be equal to or greater than about 5%, more narrowly equal to or greater than about 10%, yet more narrowly equal to or greater than about 20%, of the balloon cell perimeter  696  (i.e., the total length of the wall of the balloon cells in lateral section, i.e., the section shown in  FIG. 24   b ). 
         [0199]    The shell inner perimeter in a plane can be about equal to the shell inside radius  706  multiplied by 2 multiplied by pi. The sum of the arc lengths of all the shell contact lines  712  in a plane in the annular balloon structure  682  may be greater than 30% of the shell inner perimeter, more narrowly greater than 45%, still more narrowly greater than 55%, for example 61%. 
         [0200]    A bond may be formed between the balloon segment  656  and the shell  678  at the shell contact line  712  with adhesive, solvent, heat or combinations thereof. The shell  678  may have adhesive  208  on the shell inside surface, for instance a thermoplastic or a thermoset. 
         [0201]    The arc length of the shell contact line  712  may be greater than 10% of the balloon cell perimeter  696 , more narrowly greater than 15%, still more narrowly greater than 20%, for example 24%. 
         [0202]      FIG. 25   a  shows an inflated spiral balloon  650  (such as shown in  FIG. 20   a ) with a shell  678 . The shell  678  may wrap, encircle or enclose the balloon  650 . The shell  678  may entirely or partially (as shown) cover the balloon  650 .  FIG. 25   b  shows a longitudinal cross-section H-H of the annular balloon structure  682  shown in  FIG. 25A . 
         [0203]      FIG. 26   a  shows an inflated spiral balloon with a shell  678 . The balloon  650  shown in  FIG. 26A  may have similar or identical dimensions to the balloon  650  shown in  FIG. 25A . The shell  678  shown in  FIG. 26A  may have a smaller shell outside radius  708  than the shell  678  shown in  FIG. 25A . The shell  678  in  FIG. 26A  may be placed over the balloon  650 . The shell may compress or squeeze balloon  650  such that the balloon  650  may be deformed and driven closer to the shell longitudinal axis  26 . The shell  678  may be in tension when the balloon  650  is inflated.  FIG. 17   b  shows a longitudinal cross-section of a spiral balloon with a shell  678 . Shell contact line  712  may be oriented in the longitudinal direction. Shell leakage area may be shaped like a spiral. 
         [0204]      FIGS. 27A and 27B  illustrate that the shell  678  can have a balloon  650  in the shell interior  47 . Shell strut  716  may contain additional elements not included in the shell central section  38 . For example, shell strut  716  may comprise additional longitudinally aligned fiber and/or additional fiber at other angles to the longitudinal axis and/or an additional polymer film and or shell taper reinforcements  862 . The polymer film may have a low coefficient of friction on the outermost surface, for example it may have a coefficient of friction of less than 0.25, more narrowly less than 0.15, still more narrowly less than 0.1. Proximal taper  34  and distal taper  42  may help to introduce and withdraw the annular balloon structure  682  through a standard vascular introducer. For instance, the tapers  34  and  42  may protect the balloon  650  from being damaged by rubbing on the vascular introducer or features, such as calcifications, in the body. The tapers  34  and  42  may guide the annular balloon structure  682  thru the introducer. 
         [0205]      FIG. 27B  shows cross section K-K of an inflated annular balloon structure  682 .  FIG. 27D  shows a closeup of a portion of  FIG. 27B . Balloon segments  656  can be compressed by shell  678 . The annular balloon structure  682  can have a second hollow shaft  2000   b , a third hollow shaft  2000   c  and a fourth hollow shaft  2000   d . As shown in  FIGS. 27B and 27D , fourth hollow shaft  2000   d  can fit over the outsides of shafts  2000   b  and  2000   c  to make shafts  2000   b  and  2000   c  approximately coaxial. Shafts  2000   b  and  2000   c  may slide within in the inside diameter of shaft  2000   d . Shafts  2000   b  and  2000   c  may be in fluid communication. A hollow shaft gap  2002  is formed between the distal end of shaft  2000   b  and the proximal end of shaft  2000   c.    
         [0206]      FIG. 27C  shows  FIG. 27B  with the annular balloon structure  682  in a deflated state.  FIG. 27E  shows a closeup of a portion of  FIG. 27C .  FIG. 27E  shows that shafts  2000   b  and  2000   c  move within the inside diameter of shaft  2000   d  when the annular balloon structure  682  is deflated. Hollow shaft gap  2002  increases when the annular balloon structure  682  moves from an inflated to a deflated state. The second hollow shaft  2000   b , third hollow shaft  2000   c  and fourth hollow shaft  2000   d  can form an inner lumen  154   a . The inner lumen  154   a  can extend thru the center of the annular balloon structure  682 . A guidewire may be inserted into inner lumen  154   a  to locate the balloon during a medical procedure. Third hollow shaft  2000   c  and fourth hollow shaft  2000   d  may be omitted and second hollow shaft  2000   b  may be extended to catheter tip  838 . 
         [0207]    First hollow shaft  2000   a  may be in fluid communication with hollow shaft distal port  54  and balloon inflation/deflation ports  654 . The addition of fluid or gas into ports  654  may cause balloon segments  656  to inflate and for the annular balloon structure  682  to expand. Removal of fluid or gas from ports  654  may cause balloon segments  656  to deflate and for the annular balloon structure  682  to return to a pleated state, for example as shown in  FIG. 7C . 
         [0208]      FIG. 28A  shows cross section K-K of an inflated annular balloon structure  682 .  FIG. 28C  shows a closeup of a portion of  FIG. 28A . The annular balloon structure can have a second hollow shaft  2000   b  that slidably fits into catheter tip  838 . A hollow shaft gap  2002  is formed between the distal end of shaft  2000   b  and the catheter tip pocket bottom  840 . The catheter tip  838  may have a catheter tip exit  841 . Fluid flow  870  (shown with a dashed line in  FIG. 28A ) may pass through shell apertures  714  on the distal taper  42  or proximal taper  34 , into central fluid passage  692  and through shell apertures  714  on the proximal taper  34  or distal taper  42 . 
         [0209]      FIG. 28B  shows  FIG. 27A  with the annular balloon structure  682  in a deflated state.  FIG. 28D  shows a closeup of a portion of  FIG. 28B .  FIG. 28D  shows that shaft  2000   b  moves within the catheter tip  838  when the annular balloon structure  682  is deflated. Hollow shaft gap  2002  increases when the annular balloon structure  682  moves from an inflated to a deflated state. The second hollow shaft  2000   b  can form an inner lumen  154   a . Inner lumen  154   a  may be in fluid communication with the catheter tip exit  841 . 
         [0210]      FIG. 28A  shows that balloon flexion sections  670  may stay within the volume enclosed by shell central section  38  with central length  40 .  FIG. 27B  shows that balloon flexion sections  670  may touch the shell wall  684  in taper sections  42  and  34 . 
         [0211]      FIGS. 29 and 30  show that the annular balloon structure  682  can have 2, 3, 4, 5, 6, 7, 8 or more support members  722  and/or support sheets  726 . The support members  722  and/or support sheets  726  may cross the central fluid passage  692 . Support members  722  and/or sheets  726  may be anchored to balloon segments  656  and/or second hollow shaft  2000   b . Sheets  726  may be notched or forked so that they may pass by each other. Support members  722  and/or sheets  726  may be constructed similarly similar to the shell wall  684  and be substantially non-compliant. Support members  722  and/or sheets  726  may be semi-compliant, compliant or highly compliant. Support members  722  and/or sheets  726  may made of an elastomer such as urethane. Support members  722  and/or sheets  726  may comprise a fiber. Support members  722  and/or sheets  726  may have a strain to failure of less than about 10%. Support members  722  and/or sheets  726  may be in tension when the annular balloon structure  682  is inflated and serve to control the maximum diameter of the annular balloon structure  682  when inflated. When pressure is withdrawn from the annular balloon structure  682 , support members  722  and/or sheets  726  may help to collapse the structure  682  in a way that helps pleats or flutes to re-form. The re-forming of pleats or flutes may make the collapsed balloon easier to withdraw through body lumens, for example through the vasculature and through an introducer. 
         [0212]      FIG. 31A  show that a valve  730  may be placed in central fluid passage  692 .  FIGS. 31A and 31B  show the valve  730  in a closed position.  FIG. 31C  shows the valve  730  in an open position. The valve leaflets  734  may be anchored to the balloon segments  656  or the inside of the shell wall  684 . The valve leaflets can be thin and flexible. The valve leaflets may contact the outside of second hollow shaft  2000   b  when in a relaxed state. 
         [0213]    Referring to  FIG. 31A , central fluid passage  692  may be filled with a liquid or a gas. When the pressure in the liquid or gas is higher in the distal taper  42  than the proximal taper  34 , valve leaflets  734  may open (as shown in  FIGS. 31A and 31C ) to allow fluid flow  870  through the central fluid passage. When the pressure difference in the liquid or gas between the distal taper  42  and the proximal taper  34  is reduced or removed the valve leaflets  734  may shut and reduce or eliminate fluid flow in central fluid passage  692 . Valve leaflets  734  may act as a one way valve. A pressure difference in the liquid or gas between the distal taper  42  and the proximal taper  34  pressure may be generated by a beating heart during a medical procedure. Valve leaflets  734  may serve as a temporary replacement for a heart valve (such as the aortic valve) during a medical procedure. Valve leaflets  734  may be made of a polymer film or be made similar to the shell wall  684  or be made of a highly compliant material such as, for instance, an elastomer. 
         [0214]    The exterior of shell wall  684  may be coated with a drug, such as paclitaxel. The drug may be delivered to the body when the annular balloon structure  682  is inflated during a medical procedure. Layer  72  or panel  196  may comprise a drug. For instance, Layer  72  or panel  196  could be a film soaked in a drug, a film with pores to hold drugs, a fiber matrix holding drugs or combinations thereof. Layer  72  may be an outer layer  72   a , an inner layer  72   b  or a middle layer, such as  72   c.    
         [0215]      FIG. 32A  shows a capsule  874 . Capsule  874  may be an annular balloon structure  682 .  FIG. 32B  shows a cross section of the capsule  874  in  FIG. 32A . Capsule  874  may have a capsule length  878 , a capsule diameter  882  and capsule inside diameter  890 . 
         [0216]      FIG. 32C  shows a capsule  874  with hourglass shape on the outer diameter.  FIG. 32D  shows a cross section of the capsule  874  in  FIG. 32C . Capsule  874  may have a capsule waist diameter  886 . 
         [0217]    The capsule length  878  divided by the capsule diameter  882  may form a capsule length to width ratio. The capsule length to width ratio may be from about 10:1 to about 1:1, more narrowly from about 5:1 to about 1:1, more narrowly still from about 3:1 to 1:1. The capsule waist diameter  886  may less than about 90% of capsule diameter  882 , more narrowly less than about 80% of capsule diameter  882 , still more narrowly less than about 70% of capsule diameter  882 . 
         [0218]      FIG. 33A  shows a capsule  874  with capsule taper section  894  and capsule inflation port  896 . Providing material, such as a liquid or a gas, at capsule inflation port  896  may cause capsule  874  to inflate. Withdrawing material at capsule inflation port  896  may cause capsule  874  to deflate. 
         [0219]      FIG. 33B  shows that a first capsule  874   a  and a second capsule  874   b  may be aligned concentrically and in contact to form an annular balloon structure  682  with an hourglass shape. First capsule  874   a  may be inflated or deflated at first inflation port  896   a . Second capsule  874   b  may be inflated or deflated at second inflation port  896   b . The internal lumens of capsules  874   a  and  874   b  may be connected over a portion of the area where the capsules touch. Three, Four, Five or more capsules  874  may be joined to form an annular balloon structure  874 . 
         [0220]      FIG. 34  shows a capsule  874  in a pleated condition. Capsule  874  may have a distal taper  42  with a distal taper length  44  of about 0 mm. 
         [0221]    Capsule wall  876  may comprise a fiber matrix, a layer  72  a panel  196  or combinations thereof.  FIG. 35   a  shows a fiber matrix with fiber  86  and adhesive  208 . The fiber matrix in  FIG. 35   a  may be referred to as a unidirectional fiber matrix.  FIG. 35   b  shows a fiber matrix with reinforcement fiber  86   a  and reinforcement fiber  86   b  at an angle of about 90 degrees to each other.  FIG. 35C  shows a fiber matrix with reinforcement fiber  86   a  and reinforcement fiber  86   b  placed at layer angle  738  to one another. Layer angle  738  may be from 45 to 70 degrees, more specifically 45, 50, 55, 60, 65, or 70 degrees.  FIG. 35D  shows that the fiber matrix shown in  FIG. 35D  may be combined with another unidirectional fiber matrix. Capsule  874  may have a non-compliant capsule diameter  882  when inflated. 
         [0222]      FIG. 36  illustrates that the shell  678  can be partially or completely manufactured in a pressure chamber  219 . The pressure chamber  219  can be in a pressure chamber case  218 . The pressure chamber case  218  can have a case top  220   a  separable from a case bottom  220   b . The case top  220   a  can have a case top port  222 . The case bottom  220   b  can have a case bottom port  224 . The case top port  222  can be in fluid communication with the top of the pressure chamber  219 . The case bottom port  224  can be in fluid communication with the bottom of the pressure chamber  219 . 
         [0223]    The case top can screw or otherwise tightly join to the case bottom. The pressure chamber case can have one or more o-rings (not shown) in o-ring seats  226 . 
         [0224]    The pressure chamber can have a mandrel seat  228 . The mandrel seat  228  can be configured to receive a mandrel  230 . The mandrel seat  228  can have holes or pores. The holes or pores in the mandrel seat  228  can allow pressure from the case bottom port and the bottom of the pressure chamber to reach the top surface of the mandrel seat around the mandrel and/or directly under the mandrel. 
         [0225]    The mandrel  230  can have the inner dimensions of the shell  678 . 
         [0226]    The mandrel  230  may be made from a low melting point wax or metal, a foam, some collapsing structure or an inflatable bladder. The mandrel  230  can be made from a eutectic or non-eutectic bismuth alloy and removed by raising the temperature to the melt point of the metal. The mandrel  230  can be a water soluble mandrel. The mandrel  230  can be made from aluminum, glass, sugar, salt, corn syrup, hydroxypropylcellulose, ambergum, polyvinyl alcohol (PVA, PVAL or PVOH), hydroxypropyl methyl celluslose, polyglycolic acid, a ceramic powder, wax, ballistic gelatin, polylactic acid, polycaprolactone or combinations thereof. 
         [0227]    A panel  196   a  may be positioned over the mandrel  230 . The panel  196   a  may be a single layer or multiple layers. For instance, the panel  196   a  could be a layer of film and meltable adhesive  208 . The panel  196   a  can be positioned with film on the side that touches the mandrel and adhesive on the radially outer side. 
         [0228]      FIG. 37A  illustrates that a positive pressure can be applied to the top  220   a  of the pressure chamber (e.g., through the case top port  222 ) and/or a negative pressure or differential pressure or suction or vacuum applied to the bottom  220   b  of the pressure chamber (e.g., through the case bottom port  224 ). The panel  196 A can get sucked and/or pressed down and/or formed onto the mandrel  230 . The first panel  196 A can be smoothly fitted to the mandrel  230  and adhered to the mandrel at the first adhesive  208 A. The first panel  196 A can stretch and/or yield and or/deform. The first panel  196 A can be have thinner after being stretched, yielded or formed. The first adhesive  208   a  can be water soluble. The first adhesive  208   a  can be sugar syrup. Heat may be applied to panel  196   a  before forming onto mandrel  230 . Forming of one panel  196   a  may be done more than once on different sized mandrels before the panel  196   a  reaches the form shown in  FIG. 37A . 
         [0229]    Forming of panel  196   a  may also be accomplished with a mechanical die. The mechanical die may be heated and conform closely to the shape of the mandrel  230 . The mechanical die may have a shape similar to the mandrel seat  228 . 
         [0230]    The mandrel  230  and panel  196   a  can be mounted into a trimming jig. Any excess portion of the first panel  196   a  extending from the mandrel  230  can be trimmed with a blade, with a laser, with a water jet cutter, with a die cut tool or combinations thereof. The trimming jig can cover the mandrel  230  and the first panel  196   a  attached to the mandrel. Several panels  196   a  and/or layers  72  can be formed over the mandrel  230  and cut. The panels  196   a  and/or layers  72  may be trimmed at the same time or one at time. 
         [0231]      FIG. 37B  illustrates that the mandrel can have the excess area of the first panel  196 A removed in preparation for attachment of the second panel  196   b.    
         [0232]    A second adhesive  208   b  can be applied to the first panel  196   a  around the perimeter of the second panel&#39;s  196   b  contact area with the first panel  196   a . The mandrel  230  can be seated in the mandrel seat  228  with the first panel  196   a  in the mandrel seat. 
         [0233]      FIG. 37C  illustrates that after the case top  220   a  is secured to the case bottom  220   b , the positive and/or negative pressures can be applied to the pressure chamber as described infra. The second panel  196   b  can be smoothly fitted or pressure formed to or against the mandrel  230  and adhered to the first panel  196   a  at the second adhesive  208   b . Adhesion can be accomplished by the application of heat. The first and second panels ( 196 A and  196 B) can form the inner layer  72   b  or bladder  52  of the shell wall  684 . The inner layer may be leaktight. The inner layer may be capable of sustaining pressure. Multiple layers can be made by repeating the method described infra. The pressure chamber can be heated, for example, to decrease the viscosity of and decrease the modulus of the panels  196 . 
         [0234]      FIG. 37D  shows cross section L-L with the mandrel  230  omitted. Bladder  52  may have first internal seam  69   a , second internal seam  69   b  inner layer first panel  74   a , inner layer second panel  74   b  and inner layer  72   b . The bladder  52  may be leaktight. 
         [0235]      FIG. 38A  shows the bladder  52  after being fit over a mandrel  230  (mandrel  230  is inside bladder  52  and not directly shown in  FIG. 38A ). The bladder  52  may be made slightly larger in diameter and/or longer in length than the mandrel  230  onto which the bladder  52  is fit. This may allow the bladder  52  to be re-assembled on the mandrel  230  with an internal seam  66  that may be sealed.  FIG. 38A  shows a longitudinal seam  66  running the length of the bladder  52 . The seam  66  may be sealed with adhesive, by fusing, by heating, with a solvent or combinations thereof. The sealed bladder  52  may form the inner layer  72   b  of a shell  678  and be leak-tight. Seam  66  may be an external seam  66   a  or internal seam  66   b.    
         [0236]      FIG. 38B  illustrates that the first bladder portion  52   a  can overlap at a lap joint or overlap (as shown), abut at an abutment, or flange with the second bladder portion  52   b  at the seam  66 . Seam  66  may be angled, vertical or a spiral or combinations thereof. 
         [0237]      FIG. 39A  shows a cross section of a tow  270 . The tow  270  may contain about 6, 25, 100, 500 or 1500 monofilaments. The tow  270  may have a tow height  271  and a tow width  272 . The tow  270  may be approximately circular. For example, the tow height  271  and tow width  272  may be about 0.025 mm (0.001 in) to about 0.150 mm (0.006 in), more narrowly about 0.050 mm (0.020 in) to about 0.100 mm (0.040 in), still more narrowly about 0.075 mm (0.003 in). The tow  270  may be loosely held together by a polymer finish (not shown). 
         [0238]      FIG. 39B  shows that tow  270  may contain a marker wire  190 . Marker wire  190  may be circular, as shown, and radiopaque. 
         [0239]      FIG. 39C  shows the tow  270  after the tow  270  has been spread. The tow  270  may be flattened or spread by passing the tow  270  through a closely spaced set of rollers that form a narrow pinch gap. The tow  270  may be spread by pulling the tow  270  under tension over a set of rollers or pins. After spreading, the tow  270  may have a tow height  271  less than about twice the fiber height  1068 , for example about the same as fiber height  1068 . The fiber height  1068  and fiber width  1072  may be substantially unchanged after spreading. For example, the fiber width  1072  and fiber height  1068  may be about 15 μm (0.0006 in), tow width  272  may be about 210 μm (0.008 in) and tow height  271  may be about 15 μm (0.0006 in). The marker wire  190  is not shown in  FIG. 39C  but may be present after the tow  270  has been spread. 
         [0240]      FIG. 40A  illustrates that a layer of fiber matrix can be made on a roller  232 . The roller  232  can be configured to rotate about a roller axle  234 . The roller  232  may have a diameter from about 100 mm to about 1,000 mm. The roller  232  may be made or coated with an anti-stick material such as a fluoropolymer. 
         [0241]      FIG. 40B  illustrates that a releaser  236 , such as a release layer, can be placed around the circumference of the roller  232 . The release layer can be a low friction film or coating. The release layer may be a thin and/or flexible fluoropolymer sheet. 
         [0242]      FIG. 40C  shows that an adhesive  208  can be placed on the releaser or directly onto the roller  232  (e.g., if no releaser  236  is used). The adhesive  208  may be a thermoplastic film. The adhesive  208  may be a thermoset adhesive. The adhesive  208  may be a solvated thermoplastic or thermoset. The adhesive  208  may have a backing film, such as paper. 
         [0243]      FIG. 40D  shows the application of the reinforcement fiber  86  to the roller  232 . The fiber  86  may be unwound from a spool (not shown) and rolled onto the top surface of the adhesive  208 . Before winding, the fiber  86  may be infused or coated with an adhesive  208 , a solvent, or both. The coating may be a thermoplastic. The fiber  86  may have been previously flattened as detailed supra. The fiber  86  may have a non-circular cross section, such as a rectangle or an ellipse. Any coating or sizing on the fiber may have been removed using a solvent. The fiber  86  may be placed with a gap between each successive fiber wrap. The gap may be less than about 200 μm (0.008 in), more narrowly less than about 5 μm (0.0002 in). A heat source or a solvent may be used to fix the fiber  86  to the adhesive  208  (i.e., tack the fiber  86  in place on the adhesive  208 ), to melt or solvate a material onto the release layer  236 , to melt or solvate a material on the fiber  86  or combinations thereof. For example, a separate resistive heater, a laser, a source of hot air, or an RF welder may be used. A solvent such as methyl ethyl ketone or tetrahydrofuran may be used. The fiber  86  can be wound with a pitch of 3000 to 30 turns per 1 inch (25.4 mm). The pitch can be chosen based on the total size of the fiber  86  or tow  270  being applied and the chosen gap between each subsequent fiber  86  or tow  270  on the roller  232 . Applications of a single monofilament  274 , which may be a wire, can have pitches from about 2000 to about 100 turns per 1 inch (25.4 mm). 
         [0244]      FIG. 40E  shows reinforcement fiber  86  on top of adhesive  208  on top of release layer  236 .  FIG. 40E  may show a cross section after the operation shown in  FIG. 40D  is performed. 
         [0245]      FIG. 40F  illustrates that the roller can be placed between a vacuum top sheet  238   a  and a vacuum bottom sheet  238   b , for example in a vacuum bag. A vacuum seal tape  240  can surround the roller  232  between the vacuum bottom and top sheets  238   b  and  238   a , respectively. Air can be removed from between the vacuum top and bottom sheets  238   a  and  238   b  and within the vacuum seal tape, for example by suction from a suction tube  242 . Inside and/or outside of the vacuum bag, the roller  232  can be heated, for example to melt or cure the adhesive  208 . Roller  234  can be removed from the vacuum bag, for example after melting or curing of the adhesive is complete. 
         [0246]      FIG. 40G  shows the removal of the panel  196 . For instance, a cut may be made substantially perpendicular to the fiber. The panel  196  may be peeled away from the release layer. The panel  196  may be substantially foldable and/or flexible. 
         [0247]      FIG. 40H  illustrates that the panel  196  of fiber matrix can be removed from the roller  232 . For example, the panel  196  can be peeled off the releaser  236 . The panel  196  can be repositioned on the roller  232  at about 90 degrees to the layer&#39;s previous angle and additional reinforcement fibers  86  can be applied as shown in  FIG. 39D . This may result in a panel  196  with fibers  86  running perpendicular to each other (e.g., a “0-90” layer, so called for the angle the two layers of fiber make with respect to each other). The panel  196  can be cut into a smaller panel. For instance, the panel  196  can be cut with a trimming jig, a laser, a water jet cutter, a die cut tool, or a combination thereof. 
         [0248]      FIG. 41A  shows that a panel  196  may have reinforcement fibers  86   b  oriented substantially parallel to panel longitudinal edge  332 . The panel  196  can have a panel width  334 . The panel width  334  can be about equal to the circumference of the shell  678  in the central section  38 . The panel  196  can have a panel length  335 . The panel length  335  can be greater than the shell length  28 . The panel  196  can have a panel rectangular section  336  and one or more panel serrations  338   a ,  338   b  and  338   c . Each panel serration  338   a ,  338   b  and  338   c  can have a portion of the panel  186  that forms a portion of the stem  30  or  43  and taper  34  or  44 . Each serration  338   a ,  338   b  and  338   c  can have a serration edge  339   a ,  339   b  and  339   c , respectively. The angle between the serration edges  339  and a line parallel to the reinforcement fibers  86   b  can be a panel serration angle  340 . The panel serration angle  340  can be about 30°, about 20°, about 10°, or about 0°. A first panel serration  338   a  can be substantially in line with a second panel serration  338   b . One or more fibers  86   b  may run from the terminal end of the first serration  338   a  to the terminal end of the second serration  338   b.    
         [0249]      FIG. 41B  illustrates that longitudinal reinforcement fiber  86   b  can be parallel with longitudinal edge  332 . Second longitudinal reinforcement fiber  87   b  can be parallel with the fiber  86   b . Fibers  86   b  and  87   b  can be separated by fiber separation areas  614 . The fiber separation areas  614  may separate fibers  86   b  and  87   b  by about 2 mm, more narrowly less than about 1 mm, still more narrowly less than about 0.25 mm. The fiber separation areas  614  may be distributed on the panel such that no area  614  substantially overlaps any other area in the X and/or Y direction. The fiber separation areas  614  may be positioned in the X and Y directions on the panel  196  in a pattern sufficient to prevent any fiber from reaching all the way across the panel rectangular section in the X direction. The shell  678  in  FIG. 5  may be built in part with the panel  196  shown in  FIG. 41B . Fibers  86   b  and  87   b  may have fiber lengths  88  less than about 80% of the shell length  28  more narrowly less than about 75% as long, more narrowly less than about 70% as long, still more narrowly less than about 65% as long, still more narrowly less than about 60% as long. 
         [0250]      FIG. 41C  shows that a panel  196  can have a panel rectangular section  336  and one or more panel serrations  338   a ,  338   b  and  338   c . Panel serration  338   b  can be oriented in the Y direction substantially midway between panel serrations  338   a  and  338   c . Panel serration  338   b  can be oriented in the Y direction substantially closer to either panel serrations  338   a  or  338   c . The longest reinforcement fiber length  88  in panel  196  may be less than about 75% of the length  28  of the shell, more narrowly less than about 70%. 
         [0251]      FIG. 42A  shows that panel  196  may contain reinforcement fibers  85   a  and  85   b  arranged in a woven pattern. A woven pattern can have fibers  85   a  and  85   b  that alternately pass over and under each other. 
         [0252]      FIG. 42B  shows that the panel  196  may contain reinforcement fibers  85  in a braided configuration. 
         [0253]      FIG. 42C  shows that the panel  196  may contain reinforcement fibers  85  of various lengths in random orientations, sometimes referred to as chopped or chopper fiber. 
         [0254]      FIGS. 43A and 43B  illustrate that a panel  196  may be applied to a mandrel  230  with none, one or more layers  72  on the mandrel  230 . The panel  196  may be joined to layers  72  by the application of adhesive or by heat or by combinations thereof. The panel  196 , when folded onto the shape of the mandrel  230  may give a substantially complete coverage of the mandrel  230  with minimal or no overlap of the panel  196 . Panel rectangular section  336  may cover the shell central section  38 . Panel serrations  338  may cover proximal taper  34 , distal taper  42 , proximal stem  30  and distal stem  43 . 
         [0255]    A die may be used to press the panel  196  onto the shell  678 . The die may be heated and the panel  196  may contain a thermoplastic. The die may melt the thermoplastic and adhere the panel  196  to the shell  678 . The die may be shaped to match the mandrel  230  shape. After attaching two serrations  338  (one serration at each end of the mandrel  230 . See  FIG. 43A ), the mandrel  230  may be rotated about its longitudinal axis to advance the next set of serrations  338  into place under the die. The die may again press two serrations  338  into place on the shell  678 . Subsequent use of the die in this manner may attach substantially the entire panel  196  to shell  678  as shown in  FIG. 43B . 
         [0256]      FIG. 44  illustrates that fiber  86  can be wound over the mandrel  230  or over shell  678 . The fiber  86  may be continuous or discontinuous. The mandrel can be rotated, as shown by arrow  252 , about the mandrel longitudinal axis  250  or shell longitudinal axis. The first spool  244   a  can be passively (e.g., freely) or actively rotated, as shown by arrow  254 , deploying fiber  86  (shown) or tow  270 . Before or during winding, the fiber  86  may be infused or coated with an adhesive, a solvent, or both. The coating may be a thermoplastic. A fiber distal end can fix to the shell  678  or directly to the mandrel  230 . 
         [0257]    The fiber  86   a  may be wound with a gap between each successive fiber wind. The gap can be less than about 200 μm (0.008 in), more narrowly less than about 5 μm (0.0002 in). 
         [0258]    The fiber  86  can be wound with a pitch of about 3000 to about 30 winds per 1 inch (25.4 mm). The pitch can be chosen based on the total size of the fiber  86  or tow  270  being applied to the part from first spool  244   a  and the chosen gap between each subsequent fiber  86  or tow  270  on the part. Applications of a single monofilament  274 , which may be a wire, can have pitches from about 2000 to about 100 turns per 1 inch (25.4 mm). 
         [0259]    A tool arm  246  can be attached to a rotating tool wheel  248 . The tool arm  246  can rotate and translate, as shown by arrows  256  and  258 , to position the tool wheel  248  normal to and in contact with the shell  678 . A second tool wheel  248 ′ (attached to tool arm  246 ′) can have a range of motion sufficient to apply pressure normal to the surface of a shell taper section. 
         [0260]    The tool wheel  248  can press the fiber  86  or tow  270  against the shell  678  and spread the monofilaments  274 . The tool wheel  248  may help to adhere the tow  270  to the shell, for example by applying pressure and following closely the surface of the shell. The tool wheel  248  can be heated to soften or melt the material on the surface of the shell  678 . Another heat source or a solvent may be used to tack the fiber in place, to melt or solvate a material on the shell, to melt or solvate a material on the fiber or combinations thereof. A separate resistive heater, a laser, a UV light source, an infrared light source, a source of hot air, or an RF welder may be used with our without the tool wheel  248  to attach the fiber. A solvent such as methyl ethyl ketone or tetrahydrofuran or alcohol or combinations thereof may promote adhesion of the fiber  86  and may be used with our without the tool wheel  248 . The tool wheel  248  can be made of or coated with a non-stick material. The tool wheel  248  may not rotate. The tool wheel  248  may comprise a hard surface, for example carbide. 
         [0261]    A second spool  244   b  may deploy marker wire  190  during a winding operation. Second spool  244   b  may also deploy a reinforcement fiber  85  (not shown). Marker wire  190  (or reinforcement fiber  85 ) may be applied simultaneously with fiber  86  and/or tow  270  to the shell. Marker wire  190  may interleave with reinforcement fiber  86  to form a single fiber layer on shell  678 . Marker wire  190  may be deposited on top bellow another existing fiber layer. 
         [0262]    The resulting layer deposited in  FIG. 44  can have a layer thickness  216  of from about 1 μm (0.00004 in) to about 50 μm (0.002 in), more narrowly from about 8 μm (0.0003 in) to about 25 μm (0.001 in). 
         [0263]    The techniques described in  FIGS. 36 ,  37 A,  37 B and  37 C may be used to apply additional panels  196  or layers  72  to shell  678 . For example, two panels  196  may be applied to form an outer layer  72   a  on the shell  678  as shown in  FIG. 45A . 
         [0264]      FIG. 45B  shows that a panel  196   e  can applied to the proximal end of the balloon. Similarly, a panel  196   f  can be applied to the distal end of the balloon. The panels  196   e  and  196   f  could be like those shown in  FIGS. 46A and 46B . 
         [0265]      FIG. 46A  shows a panel  196  with panel cutout  842  and panel lobe  846 . Panel cutout  842  can be aligned on a shell  678  to form an aperture  714 . Panel lobe  846  can be placed on a shell  678  to form a shell reinforcement lobe  866 . 
         [0266]      FIG. 46B  shows a panel  196  with a panel cut  850 . Panel cut  850  may allow the panel to form over shell  678 . 
         [0267]      FIG. 47  illustrates that a wash tube  264  can be inserted into a mandrel washout port  262 . A dissolving or solvating fluid can be delivered through the wash tube and into the washout port  262 . The mandrel can be removed by delivery of a fluid solvent such as water, alcohol or a ketone. The solvent may be applied during the consolidation process such that the solvent melts or partially softens the mandrel and concurrently pressurizes the bladder. The mandrel  230  can be removed by raising the mandrel to a melting temperature for the mandrel. The mandrel  230  can be removed by deflating the mandrel or by collapsing an internal structure. 
         [0268]      FIG. 48A  illustrates that the shell  678  may be placed in a shell mold  622  containing a shell pocket  624 . The shell mold  622  may be porous such that substantial amounts of gas may be drawn from shell pocket  624  thru the wall of shell mold  622  and out into the surrounding atmosphere. The shell  678  may have a tube (not shown) placed in its inner volume that may extend out either end of the shell  622 . The tube may be thin and very flexible. The tube may be a silicon rubber. 
         [0269]    A coating may be sprayed into mold  622  that bonds to the shell  678  during cure and forms an outer layer  72   a  on the shell  678 . 
         [0270]      FIG. 48B  illustrates that the shell mold  622  may be closed around the shell  678 . Pressure may be applied thru shell second fluid port such that the shell expands to contact the inside of shell pocket  624 . Alternately, the tube (not shown) extending out either end of the shell may be pressurized to force the shell into contact with pocket  624 . 
         [0271]      FIG. 48C  shows Pressure P inside the shell volume pressing the shell wall  684  outwards. Mold  622  may be placed in an oven and heated. Mold  622  may have built in heaters. The shell mold  622  may be placed under vacuum or placed in a vacuum chamber during heating. The shell mold  622  may have a texture, such as a texture created by abrading or sand blasting or bead blasting the shell mold  622 . The texture may impart a texture to the outer layer  72   b  of the shell. 
         [0272]    Heating the shell under pressure may cause one or more layers  72  to melt and/or fuse and/or bond with adjoining layers  72 . Melting under pressure may remove voids in the shell wall. The inner and outer films may not melt. Heating the shell under pressure may cause the walls of the shell  678  to fuse or laminate into one continuous structure. The shell outer layer  72   a  may be substantially smoothed by this process. The shell outer layer  72   a  may be permeable or perforated such that gas or other material trapped in the shell wall  684  during manufacture may escape when the shell is heated under pressure. 
         [0273]    The shell outside radius  708  may be very accurate and repeatable. For instance, at a given pressure, the outside radius  708  of a group of shells  678  may all be within about 2% (+/−1%) of each other. For instance, if the nominal dimension of the outside radius  708  of the shell is about 12 mm at about 60 psi (414 kPa), all shells may have an outside radius  708  of about 11.88 mm to about 12.12 mm. 
         [0274]    A shell  678  can be clamped in a pleating tool with two, three, four, five or more removable pleating blocks. Heating the pleating blocks to about 80C and then pressing them against the shell  678  for about 1 minute causes the shell to become pleated or fluted. Commercial pleating machines such as folding machinery from Interface Associates (Laguna Niguel, Calif.) can also be used. A small amount of wax may be used to hold the pleated and folded shell into its desired shape. 
         [0275]    As shown in  FIGS. 49A and 49B , a balloon  650  may be placed in an insertion tool  854 . Before being placed in the insertion tool  854 , the balloon  650  may be coated in an adhesive  208  or a solvent. The insertion tool  854  may comprise a tube that will not adhere to most adhesives, for example the tube may comprise a fluoropolymer. 
         [0276]      FIG. 49C  shows that apertures  714  may be cut in the shell  678 , for example with a laser  858 . A shell  678  may be fabricated with apertures  714  already in place.  FIG. 49D  shows that insertion tool  854  may be inserted through aperture  714  into shell interior  47 . Insertion tool  854  may be inserted through the interior volume of shell proximal stem  30  or shell distal stem  43  or any other orifice in the shell  678 . A cut in the shell  678  may be made to allow the insertion tool  854  into shell interior  47 .  FIG. 49E  shows that the insertion tool  854  can be removed leaving balloon  650  in the shell interior  47 .  FIG. 49F  shows that balloon  650  can be inflated inside shell  678 . Adhesive  208  or a solvent or the application of heat may bond balloon  650  to the inner wall of shell  678  forming annular balloon structure  682 . 
         [0277]      FIG. 50  illustrates a balloon catheter. Inflation fluid may be provided by detachable syringe  472  thru catheter Y-fitting  634 . Inflation fluid may flow between the inside wall of first hollow shaft  2000   a  and the outside wall of second hollow shaft  2000   b . Inflation fluid may flow into the balloon  650  to inflate the annular balloon structure  682 . A guide wire may be inserted at guidewire port  632  and pass thru the interior of the second hollow shaft  2000   b.    
         [0278]      FIG. 51  illustrates a cross section of an annular balloon structure  682  in a substantially deflated and pleated or folded configuration. The annular balloon structure  682  is shown in a tube  428  with a tube inside diameter  436  and a tube inside diameter cross sectional area  434 . The annular balloon structure  682  may be inserted into the tube  428  without damaging the annular balloon structure  682 . The tube  428  may be, for instance, an introducer or a balloon protection sleeve used to store the balloon. 
         [0279]    The compression ratio of the annular balloon structure  682  can be from about 3:1 to about 10:1, more narrowly from about 5:1 to about 7:1. The compression ratio can be the ratio between twice the shell outside radius  708  of the substantially inflated annular balloon structure  682  and tube inside diameter  436 . For instance, an annular balloon structure  682  with shell outside radius  708  equal to about 12.2 mm can be inserted into a tube  428  with a tube inside diameter  436  of about 4.8 mm, more narrowly about 4 mm, still more narrowly about 3.6 mm. 
         [0280]    The annular balloon structure  682  can have a packing density equal to or greater than about 40%, more narrowly greater than or equal to about 55%, yet more narrowly equal to or greater than about 70%. The packing density can be the percentage ratio between the cross sectional area of the walls of the annular balloon structure  682  and the tube inside diameter cross sectional area  434 . 
         [0281]    The packing density and compression ratios for the annular balloon structure  682  can remain substantially constant and the wall strength of the annular balloon structure  682  can remain substantially constant with repeated insertions or withdrawals from tube  428  and/or inflations and deflations of the annular balloon structure  682 , for example 10 or 20 or 40 insertions and withdrawals or inflations and deflations. 
         [0282]    The annular balloon structure  682  can have an unsupported burst pressure. The unsupported burst pressure is the pressure at which the annular balloon structure  682  ruptures when inflated in free air without any external constraint on the walls at about 1 atm external pressure and about 20° C. temperature. The unsupported burst pressure can be from about 2 atm to about 20 atm, more narrowly from about 3 atm to about 12 atm, still more narrowly about 4 atm to about 8 atm, for example 5 atm, 6 atm or 7 atm. 
         [0283]    The annular balloon structure  682  can be non-compliant or inelastic. For example, the annular balloon structure  682  can have a failure strain of less than about 0.30, more narrowly less than about 0.20, still more narrowly less than about 0.10, yet more narrowly less than about 0.05. 
         [0284]    The failure strain of the annular balloon structure  682  is the difference between the shell outside radius  708  when the balloon is inflated to 100% of the burst pressure and the shell outside radius  708  when the balloon is inflated to 5% of the burst pressure (i.e., to expand from a deflated state without stretching the wall material) divided by the shell outside radius  708  when the balloon is inflated to 100% of the burst pressure. 
         [0285]    The annular balloon structure  682  can have a compliance of less than about 2% per atmosphere, more narrowly less than about 1% per atmosphere, still more narrowly less than about 0.7% per atmosphere, yet more narrowly less than about 0.4% per atmosphere. 
         [0286]    The annular balloon structure  682  can be inflated to a pressure A and a pressure B. Pressure B may be a higher pressure than pressure A. Pressures B and A may be positive pressures. Pressures B and A may be greater than 1 atm. Delta pressure may be pressure B minus pressure A. Delta radius may be the shell outside radius  708  when annular balloon structure  682  is inflated to pressure B minus the shell outside radius  708  when annular balloon structure  682  is inflated to pressure A. Compliance may be Delta radius divided by the shell outside radius  708  when annular balloon structure  682  is inflated to pressure B divided by Delta pressure. 
         [0287]    A shell  678  can be constructed with fiber  85  patterns similar to those shown in  FIG. 4 . For example, fiber reinforcement member  85   c  can be omitted and fiber  85   a  can be placed at +20 degrees and fiber  85   b  can be placed at −20 degrees to the shell longitudinal axis. First reinforcement fibers  85 A may form a layer angle  738  with respect to and second reinforcement fibers  85   b . The layer angle  738  can be about 40 degrees. As shell  678  is placed under tension by balloon  650 , the angle between the fibers will gradually increase until the layer angle  738  is about 70 degrees. This is the angle  738  where the fibers balance the longitudinal and hoop loads in the shell. The fibers may change their angle with respect to each other by straining the adhesive. Shell  678  may rapidly expand to a first diameter where the a layer angle  738  is, for example, about 40 degrees and then slowly expand in diameter  50  as internal pressure on the shell  678  from balloon  650  is increased. By choosing the initial diameter  50  and layer angle  738 , a shell  678  can be designed that allows for a variety diameters  50  to be achieved. 
         [0288]      FIG. 52  shows a cross section of the heart  562 . The heart  562  has an aorta  568 , a left ventricle  570  and an aortic valve  564   
         [0289]      FIG. 53  is a graph that shows how the percent stenosis creates acceptable, difficult and critical flow conditions in both the rest and stress conditions in a patient. The acceptability of a stenotic condition would further vary as a function of the time spent in each condition. 
         [0290]      FIGS. 54A and 54B  illustrate that a guidewire  572  can be inserted through the aorta  568  and positioned in the left ventricle  570  of the heart  562 . The annular balloon structure  682  can be slidably inserted over the guidewire through the aorta  568 . The annular balloon structure  682  may be in a deflated or pleated state when first placed in the aortic valve  564 . The annular balloon structure  682  can be positioned to align along the balloon longitudinal axis with the aortic valve leaflets  566 . The annular balloon structure  682  can also be rotated about the balloon longitudinal axis to align with the aortic valve  564 , for example when cutting apart attached leaflets  566  in a bicuspid aortic valve with a flange, a vane, a blade, other cutting element described herein, or combinations thereof. Fluid flow  870  may pass out of the left ventricle  570  through aortic valve leaflets  566  and into the aorta  568 . Fluid flow  870  may comprise blood flow. 
         [0291]      FIG. 54C  shows the annular balloon structure  682  in an inflated configuration. The annular balloon structure  682  can be non-compliant and open the aortic valve  564  to a precise dimension (for example, about 20 mm or about 24 mm). The annular balloon structure  682  can fixedly reconfigure and press the aortic valve leaflets  566  against the outer wall or annulus  582  of the aortic valve  564 . The annular balloon structure  682  can radially expand the aortic valve annulus  582 . 
         [0292]    Fluid flow  870  may pass through shell apertures  714  on the distal taper  42 , into central fluid passage  692  and through shell apertures  714  on the proximal taper  34  thus allowing for perfusion of blood while the balloon structure  692  is inflated. The central fluid passage  692  could have a cross sectional area of 0.3 to 1.2 centimeters squared, more narrowly 0.5 to 0.8 centimeters squared. 
         [0293]    When annular balloon structure  682  is inflated, there may be a pressure differential between left ventricle  570  and aorta  568 . For instance, the pressure differential may be from about 5 mm Hg to about 50 mm Hg, more narrowly from about 10 mm Hg to about 40 mm Hg, still more narrowly, from about 10 mm Hg to about 25 mm Hg. 
         [0294]    Perfusion may allow the physician to leave the balloon structure inflated in the aortic valve  564  for longer than would be allowed with a balloon that did not perfuse while still avoiding significant harm to the patient or the patient&#39;s hemodynamics. Increasing inflation time may allow for a more careful and accurate remodeling of the vasculature, such as that done during a valvuloplasty or a PCTA procedure. 
         [0295]    One or more segments  656  of balloon  650  may employ a compliant material. Raising and lowering the pressure in these compliant segments  656  may cause the segment volume to change. A change in the segment  656  volume may cause the area of the central fluid passage  692  to change. A physician may initially place the annular balloon structure  682  and then adjust pressure in the balloon  650  or balloon segments  656  to adjust the flow area gap  693 . The compliant balloon segment  656  may be an additional balloon enclosed by shell  678  with an inflation lumen separate from the one used to inflate balloon  650   
         [0296]    The physician may inflate the annular balloon structure  682  until the structure  682  makes contact with the aortic valve  564  or the valve leaflets  566  or other vascular structures. This contact with the vasculature may be confirmed by the use of small bursts of radiopaque contrast. Once the annular balloon structure  682  is in contact with the vasculature, increases in the pressure delivered to annular balloon structure  682  can be used to make changes in central section outside diameter  50  of the annular balloon structure and thus change the shape of the patient&#39;s vasculature. The change in shape of the vasculature can be monitored by ultrasound, fluoroscope or other methods known in the art. Changing the shape of the patient&#39;s vasculature via this method may take more than 10 seconds, more narrowly more than 30 seconds, still more narrowly more than 60 seconds while not adversely affecting patient health. 
         [0297]    The heart  562  may be allowed to beat at its normal rhythm during the procedure. The heart  562  may be forced to beat at an elevated rhythm during the procedure. 
         [0298]      FIG. 54D  illustrates that the annular balloon structure  682  can be deflated, contracted and withdrawn from the aortic valve leaflets  566 . 
         [0299]    FIG.  54 FE shows the aortic valve leaflets  566  with a larger opening than before the procedure. 
         [0300]    Instead of using a guidewire, an IVUS or OCT system can be inserted in the inner lumen  154   a . These systems may allow visualization of the aortic valve  564 , for instance the positioning of the valve leaflets  566  at any point during the procedure detailed in  FIGS. 54A-54F . 
         [0301]    The method described in  FIG. 54  above can be performed on an aortic, mitral, pulmonary, tricuspid or vascular valve. This method may be described as balloon valvuloplasty or balloon aortic valvuloplasty. This procedure may be described as pre-dilation when it used to prepare the aortic valve for the implantation of a prosthetic valve. This procedure may also be employed after a prosthetic valve is in place in order to better seat the valve into the patient&#39;s anatomy. In this case, it is often referred to as “post-dilation”. 
         [0302]    Referring now to  FIGS. 55A-55F , the annular balloon structure  682  can be used to deploy a prosthetic valve in, for instance, the aortic valve  564  near the coronary ostia  583 . A guidewire  572  may first be introduced thru the aorta  568  into the left ventricle  570  as shown in  FIG. 55A . Next, as shown in  FIG. 55B , a balloon catheter carrying prosthetic heart valve  626  and deflated annular balloon structure  682  may be introduced over guidewire  572  into aortic valve  564 . In  FIG. 55C , annular balloon structure  682  is inflated to expand the prosthetic heart valve  626  into the aortic valve  564 . While the annular balloon structure  682  is inflated, fluid (for example, blood) flow  870  may pass through shell apertures  714  on the distal taper  42 , into central fluid passage  692  and through shell apertures  714  on the proximal taper  34 . In  FIG. 55D , the annular balloon structure  682  is deflated and separated from valve prosthesis  626 , leaving the valve prosthesis  626  implanted in the aortic valve  564 .  FIGS. 55E and 55F  show the prosthetic valve closing ( 55 E) and opening ( 55 F) immediately after the annular balloon structure  682  is withdrawn. 
         [0303]      FIG. 56A  illustrates that the annular balloon structure  682  can be positioned over a guidewire  572  or stylet in a body lumen  574  having a constriction  576  on the interior of the lumen wall  578 . A stylet may be stiffer than a guidewire. 
         [0304]      FIG. 56B  illustrates that the annular balloon structure  682  can be inflated and expanded. The annular balloon structure  682  can remodel the body lumen  574 , pushing the constriction  576  radially away from the shell longitudinal axis  26 . The annular balloon structure  682  can deploy a stent to the constriction  576 . While the annular balloon structure  682  is inflated, fluid (for example, blood) flow  870  may pass through shell apertures  714  on the proximal taper  34 , into central fluid passage  692  and through shell apertures  714  on the distal taper  42 . 
         [0305]      FIG. 56C  illustrates that the annular balloon structure  682  can be deflated, contracted and removed from the body lumen  574 . The body lumen  574  can remain patent after the annular balloon structure  682  is removed, for example restoring blood flow past a treated atherosclerotic length. 
         [0306]    Body lumen  574  may be a vessel or an airway. Constriction  576  may be a atherosclerotic plaque or a local narrowing of the body lumen  574   
         [0307]    The annular balloon structure  682  can be implanted in the body semi-permanently or permanently. 
         [0308]    The annular balloon structure  682 , can be used for Kyphoplasty, angioplasty including CTO dilation, stent delivery, sinuplasty, airway dilation, valvuloplasty, drug or other fluid delivery through the balloon, radiopaque marking, incising the inside of a vessel (e.g., to open or expand a vessel), brachytherapy, intentionally obstruct a vessel, or combinations thereof. The annular balloon structure  682  can be used to deliver one or more stents and/valves and/or emboli filters to the coronary blood vessels (e.g., arteries or veins), carotid artery, peripheral blood vessels, the GI tract, the biliary ducts, the urinary tract, the gynecologic tract, and combinations thereof. 
         [0309]    The reinforcement fibers  85 ,  86  and  87  can be identical to or different from each other. 
         [0310]    Any elements described herein as singular can be pluralized (i.e., anything described as “one” can be more than one), and plural elements can be used individually. Any species element of a genus element can have the characteristics or elements of any other species element of that genus. The term “comprising” is not meant to be limiting. The above-described configurations, elements or complete assemblies and methods and their elements for carrying out the invention, and variations of aspects of the invention can be combined and modified with each other in any combination.

Technology Classification (CPC): 0