inflatable structure device for use as a reinforced inflatable medical device

专利摘要:
ENHANCED INFLATABLE MEDICAL DEVICES. The present invention relates to an inflatable structure for use in biological lumens and methods of production and use thereof. The structure can have an inflatable balloon formed in a plurality of cells surrounded by a carcass. A strip can extend between the cells. The carcass may have tapered proximal and distal necks, longitudinally oriented grooves and openings at the proximal and distal ends of the carcass. The carcass may include a reinforcement that has tapered sections over the necks and strips that extend between the tapered sections. A semi-flexible or malleable balloon can be placed around the outside of the inflatable structure.
公开号:BR112015008571B1
申请号:R112015008571-7
申请日:2013-10-18
公开日:2021-01-26
发明作者:Alexander Q. Tilson；Paul J. Dreyer；Mitchell C. Barham；Mark C. Scheeff；Charles S. Love；Garrett J. Gomes；Jonathan Kurniawan；Cameron S. Moore
申请人:Loma Vista Medical, Inc.；
IPC主号:

专利说明:

[001] This application claims the benefit of Provisional Patent Applications U.S. Serial Number 61 / 715,761 and 61 / 844,827, the descriptions of which are incorporated herein by reference. International Patent Application WO2012 / 099979 is also incorporated by reference into this document. BACKGROUND TECHNICAL FIELD
[002] Inflatable medical devices and methods for producing and using them are described. More specifically, invasive medical balloons, such as those used for transcutaneous heart valve implantation, are described. For example, such balloons used for transcatheter implantation of the aortic valve.
[003] Inflatable structures are widely used in medical procedures. A structure is typically inserted at the end of a catheter, until the structure reaches the area of interest. Adding pressure to the structure causes the structure to inflate. In a variation of use, the structure creates a space inside the body when inflated.
[004] The inflatable structures can be used in the heart valves, including during Balloon Aortic Valvuloplasty (BAV) and Transcatheter Aortic Valve Implant (TAVI). The structures can be used to open a stenosed aortic valve. A stenosed valve can have rigid calcified lesions that can tend to tear or puncture a structure. In addition, a precise diameter of the inflated structure may be desired for enhanced safety and control.
[005] Inflatable structures can be used to move a plaque or constriction away from the center of a vascular lumen or other lumen towards the lumen walls, such as during an angioplasty or peripheral vasculature or an airway procedure . During such a procedure, an inflatable structure at the distal end of the catheter is placed in an obstruction. As the structure is inflated, the constriction is expanded, to result in the improved flow of liquid (such as blood) or gas (such as air).
[006] Current or typical inflatable structures can be balloons. When a typical balloon is inflated, it can block a body lumen. For example, a typical balloon can block blood flow in the vasculature or air in the airways. Blocking such a vital supply of liquid or gas can create short- and long-term health problems for the patient. This blockage can minimize the time that the doctor can keep an inflated balloon.
[007] Typical balloons, when used to perform a BAV and / or TAVI procedure, will block the entire outlet of the heart in the aortic valve. This causes the pressure in the heart to increase to uncomfortable levels. This can also generate enough force to expel the balloon from the aortic valve. Finally, typical balloons provide insufficient dimensional control (particularly diametrical) and do not have good resistance to tearing and puncture (from, for example, aortic calcifications).
[008] Alternatively, a doctor can use a fast heart rate (so as to artificially accelerate the natural heart beat rate) during a BAV and / or a TAVI to minimize pressure build-up and forces on the balloon. However, the rapid rate also poses a risk to the patient. Even at a rapid frequency, typical balloons can be inflated for just a few seconds before being removed and still suffer from insufficient dimensional control and rigidity.
[009] A balloon or inflatable structure is desired which can maintain the flow of liquid or gas while providing precise shape control and which is highly resistant to tearing and puncture. SUMMARY OF THE INVENTION
[0010] An inflatable medical device such as an inflatable device is described. The apparatus may have a housing that has a longitudinal housing geometric axis, a central section and a first neck section. The first neck section can have a first end of the first neck and a second end of the first neck. The first end of the first neck may have a diameter of the first end of the first neck. The second end of the first neck may have a diameter of the second end of the first neck. The diameter of the first end of the first neck may be greater than the diameter of the second end of the first neck. The first end of the first neck may be adjacent to the central section.
[0011] The device may have a balloon at least partially inside the housing. The balloon may be attached to the housing.
[0012] The housing may have a longitudinal housing geometric axis and a central fluid passage. The central fluid passage can be radially inside the balloon in relation to the longitudinal geometric axis of the carcass. The first opening may be in fluid communication with the central fluid passage. The balloon can have a first cell and a second cell in a single cross-section of the inflatable structure. The balloon can have a balloon surface area in a single cross-section. At least 5% of the balloon surface area can be concentric (that is, have the same center of radius of curvature) in relation to the carcass.
[0013] A wall of the first cell adjacent to the second cell can be greater than about 5% in contact with the second cell. The device may have a first groove in the housing. The first groove may have a first inner groove of first groove, a second inner groove of first groove and an outer groove of first groove between the first inner groove of first groove and the second inner groove of first groove. The device may have a first opening. The first opening can be at least partially over the first groove. The first opening may be arranged in such a way that it does not cross the outer crease of the first groove.
[0014] The first neck section may have a first neck section stiffness. The center section may have a center section stiffness. The stiffness of the first neck section may be greater than the stiffness of the central section.
[0015] The device may have a tube that extends along the longitudinal geometric axis of the housing. The central fluid passage can be between the tube and the inner radius of the balloon in relation to the longitudinal geometric axis of the carcass. The tube may have a lumen that extends through it.
[0016] The first neck section may have medium wall stiffness of the first neck section. The center section may have an average center section wall stiffness. The average stiffness of the first neck section wall may be greater than the average stiffness of the central section wall. The first streak can be in the first neck section.
[0017] At least 30% of the carcass perimeter may be concentric in relation to the balloon surface area. The balloon can have a first cell and a second cell in a single cross-section of the inflatable structure. At least 30% of the carcass perimeter may be in contact with the cells.
[0018] The device can have a first cell and a second cell in a single cross section of the inflatable structure. At least 5% of the balloon surface area may be in contact with the carcass. A strip can extend between the cells to provide stability and rigidity to the device. The strip can help, for example, to support and protect the connections between cells or balloon segments. The band can add radial rigidity to the device when inflated.
[0019] The device may have a second groove. The first opening can be covered by the second groove when the inflatable structure is in a deflated configuration. The second groove may have a first inner groove of second groove, a second inner groove of second groove and an outer groove of second groove between the first inner groove of second groove and the second inner groove of second groove. The device may have a second opening. The second opening can be at least partially over the second groove. The second opening may be arranged so as not to cross the second groove external crease.
[0020] The carcass may have a second neck section. The second neck section can have a first end of the second neck and a second end of the second neck. The first end of the second neck may have a diameter of the first end of the second neck. The second end of the second neck may have a diameter of the second end of the second neck. The diameter of the first end of the second neck may be greater than the diameter of the second end of the second neck. The first end of the second neck may be adjacent to the central section. The strips can extend between the first neck section and the second neck section to provide additional longitudinal rigidity to the device. The strips can also assist in refolding the housing.
[0021] The device may have a second opening over the second neck section. The first opening and the second opening can be in fluid communication with the central fluid passage.
[0022] The central section can have a central section diameter. The diameter of the center section can be constant along the length of the center section. The balloon may be at least partially in the central section of the housing.
[0023] The carcass may have a carcass wall that has a fiber. The housing may be non-malleable. The carcass may have a fiber.
[0024] A method for using an inflatable structure in a biological body is described. The method may include placing the inflatable structure on an aortic valve on the body. The inflatable structure may have a balloon that may have a flexed first and second flexed sections. The method may include inflating the balloon. The method may include drilling the aortic valve. Drilling can include drilling through the inflatable structure. Perforation can occur while the balloon is inflated.
[0025] The opening may be in fluid communication with the passage of central fluid.
[0026] The method may also include expanding the expandable implant. Expansion of the expandable implant may include inflating the inflatable structure. At least some of the flow routes through the central fluid opening and passage. The method may include separating the expandable implant from the inflatable structure.
[0027] A method for using an inflatable structure in a biological body is described. The method may include placing the inflatable structure on an aortic valve on the body. The inflatable structure can have a housing. The balloon may be at least partially inside the housing. The housing may have a longitudinal housing axis and a central fluid passage radially inside the balloon in relation to the longitudinal housing axis. The carcass may have a groove and an opening on the groove. The opening may be in fluid communication with the central fluid passage. The method may include inflating the balloon. The method may include drilling the aortic valve. Drilling can include drilling through the inflatable structure.
[0028] A method for making the inflatable structure is described. The method may include producing a carcass. The housing 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 may include cutting openings in the first neck section. The method may include loading the balloon into the housing. The method may include pressing the balloon back into the housing. The method may include attaching such a balloon to the interior of the housing.
[0029] Producing the carcass may include applying a first film over the first neck section and applying a second film to the first neck section. Producing the substrate may include adding a first layer and a second layer to the substrate. The first layer can have a first fiber. The second layer can have a second fiber. The method may include compressing the balloon in the housing. Compression may include forming the balloon so that at least 5% of the balloon's circumference can be in contact with the carcass in the central section of the carcass. Loading may include inserting the balloon through the opening.
[0030] Another method for making the inflatable structure is described. The method may include forming a balloon along a longitudinal geometric axis of the balloon. The formation may include bending the balloon into a flexed section of the balloon. The method may also include joining the balloon to a compression fixation device. The compression fixation device can have the same internal diameter as the housing.
[0031] The inflatable medical device may additionally include reinforcements on the housing that have a proximal tapering portion, a distal tapering portion and strips that extend between them. The strips can be configured to fit inside the outer pleat lines of the housing.
[0032] The inflatable medical device may additionally include the through-flow openings in the housing. The through-flow openings can be arranged to be seated between the outer pleat lines while providing maximum flow. In some modalities, there is a single opening between each neighboring peace of external folds. In other embodiments, there are multiple openings aligned axially between each neighboring pair of external pleats. The openings can be, for example, in the shape of drops, circles, rounded squares or rounded trapezoids.
[0033] The inflatable medical device may additionally include a band or bands woven between the cells of the balloon. The strips can be continuously spiraled along the length of the balloon or can be applied as several individual strips. In some embodiments, an adhesive may be used to attach the strips to each other, to themselves and / or to the housing only where the balloon cells would otherwise come into contact with each other or with the carcass.
[0034] In some embodiments, a thin outer coating can be applied to the balloon.
[0035] In some embodiments, the inflatable medical device may additionally include a semi-flexible or malleable balloon around it. BRIEF DESCRIPTION OF THE DRAWINGS
[0036] Figure 1A illustrates a variation of the device.
[0037] Figure 1B illustrates a variation of the cross-section A-A of Figure 1.
[0038] Figures 2A to 2I illustrate variations of the device.
[0039] Figures 3A to 3D illustrate the variations of the device.
[0040] Figures 4 to 6 illustrate the variations of the device.
[0041] Figure 7A illustrates a variation of the device in a partially deflated condition.
[0042] Figure 7B illustrates a variation of the cross-section D-D of Figure 7A.
[0043] Figure 7C illustrates a variation of the cross section E-E of Figure 7A.
[0044] Figure 7D illustrates a variation of the device in a deflated condition.
[0045] Figure 8 illustrates a variation of the device.
[0046] Figures 9A to 9D illustrate variations of the device.
[0047] Figures 10A to 10B illustrate variations of the cross-section B-B of Figure 1A.
[0048] Figures 11A to 11B illustrate variations of the cross-section C-C of Figure 3C.
[0049] Figure 11 C illustrates an exemplary cross-section of a section of a balloon with a reinforcement in a location that does not have a reinforcement. Figure 11D illustrates a cross section of the balloon of Figure 11C at a location that has a reinforcement.
[0050] Figures 12 to 14B illustrate variations of the device.
[0051] Figures 15 to 18 illustrate variations of the device.
[0052] Figure 19 illustrates a method for fabricating a variation of the inflatable device.
[0053] Figure 20A illustrates a variation of the device.
[0054] Figure 20B illustrates a variation of a tool for fabricating a variation of the inflatable device.
[0055] Figure 20C illustrates a method for fabricating a variation of the inflatable device.
[0056] Figures 21 to 22B illustrate variations of the device.
[0057] Figure 23 A illustrates a variation of the device.
[0058] Figure 23B illustrates a variation of the cross-section F-F of Figure 23 A.
[0059] Figure 24A illustrates a variation of the device.
[0060] Figure 24B illustrates a variation of the cross-section G-G of Figure 24A.
[0061] Figure 25A illustrates a variation of the device.
[0062] Figure 25B illustrates a variation of the H-H cross section of Figure 25A.
[0063] Figure 26A illustrates a variation of the device.
[0064] Figure 26B illustrates a variation of the cross-section J-J of Figure 26 A.
[0065] Figure 27A illustrates a variation of the device.
[0066] Figure 27B illustrates a variation of the cross-section K-K of Figure 27A.
[0067] Figure 27C illustrates a variation of Figure 27B in a deflated state.
[0068] Figure 27D illustrates a variation of an approximate cross-sectional view of Figure 27B.
[0069] Figure 27E illustrates a variation of an approximate cross-sectional view of Figure 27C.
[0070] Figure 28A illustrates a variation of the K-K cross section of Figure 27A.
[0071] Figure 28B illustrates a variation of Figure 28A in a deflated state.
[0072] Figure 28C illustrates a variation of an approximate cross-sectional view of Figure 28A.
[0073] Figure 28D illustrates a variation of an approximate cross-sectional view of Figure 28B.
[0074] Figures 29 to 31A illustrate variations of the device.
[0075] Figures 31B to 31C illustrate details of an element shown in Figure 31 A.
[0076] Figure 32A illustrates a variation of the device.
[0077] Figure 32B illustrates a cross-sectional variation of the device shown in Figure 32A.
[0078] Figure 32C illustrates a variation of the device.
[0079] Figure 32D illustrates a variation of a cross-section of the device shown in Figure 32C.
[0080] Figures 33A to 33B illustrate variations of the device.
[0081] Figure 34 illustrates a variation of the device in a deflated state.
[0082] Figures 35A to 35D illustrate variations of a fiber matrix.
[0083] Figure 36 illustrates a variation of a tool for fabricating a variation of the inflatable device.
[0084] Figures 37A to 37C illustrate a variation of a method for making the device.
[0085] Figure 37D illustrates a cross-sectional variation L-L of Figure 37C.
[0086] Figures 38A to 38B illustrate a method for making the device.
[0087] Figures 39A to 39C are cross-sectional sections of fiber bundle variations in various configurations during a manufacturing method.
[0088] Figures 40A to 40H illustrate a method for producing a panel.
[0089] Figures 41A to 42C illustrate variations of a panel.
[0090] Figures 43A to 43B illustrate a method for manufacturing the device
[0091] Figure 44 illustrates a method for manufacturing the device.
[0092] Figures 45A and 45B illustrate a method for manufacturing the device
[0093] Figures 46A to 46B illustrate variations of a panel.
[0094] Figure 47 illustrates a variation of a method for removing the mandrel.
[0095] Figures 48A to 48C illustrate a method for manufacturing the device
[0096] Figures 49A to 49F illustrate a method for manufacturing the device
[0097] Figure 50 illustrates a variation of a deployment tool for the device.
[0098] Figure 51 illustrates a cross section of a variation of the device contracted inside a tube.
[0099] Figure 52 illustrates a cross section of a human heart.
[00100] Figure 53 is a graph showing the flow rate on the y-axis to a vascular lumen during stress and at rest corresponding to the percentage of lumen stenosis.
[00101] Figures 54A to 54E illustrate a variation of a method for using the device.
[00102] Figures 55A to 55F illustrate a variation of a method for using the device.
[00103] Figures 56A to 56C illustrate a variation of a method for using the device.
[00104] Figures 57A to 57B illustrate a variation of a carcass having a carcass reinforcement with a proximal tapering portion, a distal tapering portion and strips extending between them. Figure 57C shows an exemplary pattern for a proximal tapering portion. Figure 57D shows an exemplary pattern for a portion of distal tapering and strips. Figure 57E shows another example pattern for a distal tapering portion. Figure 57F shows another example pattern for a proximal tapering portion.
[00105] Figures 57G to 57H show an exemplary method for applying carcass reinforcements.
[00106] Figures 58A to 58E illustrate various placement of the strips of the embodiment of Figures 57A to 57E in relation to the folds in the housing.
[00107] Figures 59A to 59D illustrate various arrangements for supporting bands that extend between the balloon cells.
[00108] Figure 60A shows the longitudinal position of the support strip of Figure 59 A. Figure 60B shows an arrangement for the longitudinal position of the support strip of Figure 59B. Figure 60C shows an arrangement of the longitudinal position of the support strips of Figure 61.
[00109] Figure 61 illustrates another arrangement for the support strips that extend between balloon cells.
[00110] Figure 62 illustrates a sheet of material used to produce multiple support strips.
[00111] Figure 63 illustrates an outer covering over a balloon.
[00112] Figures 64A and 64B show a semi-flexible or malleable balloon around an inflatable medical device. DETAILED DESCRIPTION
[00113] Figures 1A and 1B illustrate a housing 678. Housing 678 can have a longitudinal geometric axis of housing 26. Housing 678 can have a housing wall 684 with an average housing thickness 686. Housing 678 can be a tube or sheath or combinations thereof.
[00114] Figure 1B illustrates a cross-section AA of the housing 678. The housing may have a housing proximal rod 30 and / or a housing proximal tapering 34 and / or a central section 38 and / or a distal housing tapering 42 and / or a distal carcass 43. Carcass 678 can have a carcass length 28. Carcass length 28 can be the sum of lengths 32, 36, 40, 44 and 45. The proximal carcass 30 has a proximal carcass shank length 32. The proximal shank length 32 can be from 3 mm to about 15 mm, more specifically about 10 mm. The carcass proximal tapering 34 can have a carcass proximal tapering length 36. The carcass proximal tapering length 36 can be from about 0 mm to about 25 mm, more specifically, from about 10 mm to about 22 mm, even more specifically, from about 16 mm to about 20 mm. The central housing section 38 can have a central section length 40. The central section length 40 can be from about 0 mm to about 55 mm, more specifically, from about 30 mm to about 50 mm. The proximal carcass tapering 34 can have a proximal carcass tapering length 44 of about 0 mm to about 25 mm, more specifically, about 10 mm to about 22 mm, even more specifically, about 16 mm about 20 mm. The distal carcass rod 43 can have a length of carcass distal rod 45. The length of distal carcass 45 can be from about 3 mm to about 15 mm, more specifically, about 10 mm. The carcass length 28 can be from about 10 mm to about 250 mm, more specifically, from about 50 mm to about 150 mm, even more specifically, about 75 mm to about 125 mm.
[00115] Housing 678 may have an outer diameter of central housing section 50. Central section 38 may have an inner radius of housing 706 and an outer radius of housing 708. Diameter 50 may be twice the outer housing radius 708. The central section 38 can be cylindrical in shape, as shown. The outer diameter of the central housing section 50 can be from about 2 mm to about 40 mm, more specifically, about 8 mm to about 30 mm, even more specifically, from about 16 mm to about 28 mm, for example, 26, 24, 22 or 20 mm.
[00116] The central section 38 can have an outer radius of frame 708. The outer radius of frame 708 can have a maximum dimension at the longitudinal location where the central section 38 meets tapers 34 or 42. The outer radius of frame 708 can have a minimum dimension in the longitudinal center of the central section 38.
[00117] The housing 678 can have a diameter of the proximal shank of the housing 31. The diameter of the proximal shank of the housing 31 can be from about 0.5 mm to about 8 mm, more specifically, about 1 mm to about 5 mm, for example, about 3 mm. Housing 678 can have a diameter of distal housing rod 41. The diameter of distal housing 41 can be from about 0.5 mm to about 8 mm, more specifically, about 1 mm to about 5 mm, for example, about 3 mm.
[00118] Frame 678 may have one or more neck sections adjacent to and extending from the center section 38. For example, a proximal neck section may be a proximal shell taper 34 that extends proximally from from the central section 38. A distal neck section can be a distal carcass taper 42 that extends distally from the central section 38. Each neck section can have a first neck end 60 and a second neck end 62 The first neck end 60 can have identical or different dimensions to the second neck end 62. The first neck end 60 can be adjacent to the central section 38. The first neck end 60 can have a first end diameter of neck 61. The second neck end 62 may have a diameter of the second neck end 63. The diameter of the first neck end 61 may be greater than the diameter second neck end diameter 63. Neck sections can be tapered, conical, multi-stretched (for example, so that they have a plurality of concave portions and a plurality of convex portions in each neck section) or combinations thereof.
[00119] Frame 678 may have an inner lumen 154A and an outer lumen 154B. The inner lumen 154A can be formed by the second hollow shaft 2000B. The internal lumen 154A can supply a lumen through the entire housing. The internal lumen 154A can allow a guidewire to pass through the interior of the housing. The outer lumen 154B can connect to the inflation / deflation ports of balloon 654. The outer lumen 154B can be formed between the inner wall of the first hollow shaft 2000A and the outer wall of the second hollow shaft 2000B.
The distal 90A tapering angle can be from about 0 to about 90 °, more specifically, about 50 ° to about 20 °, even more specifically, about 45 ° to about 30 °, for example , about 35 °. The proximal tapering angle 90b can be from about 0 to about 90 °, more specifically, about 50 ° to about 20 °, even more specifically, about 45 ° to about 30 °, for example, about 35 °.
[00121] The first hollow shaft 2000a can have a distal hollow shaft port 54. One of the inflation / deflation ports of balloon 654 can be attached to the distal hollow shaft port 54.
[00122] The housing 678 can be resilient (that is, elastic) or non-malleable (that is, non-elastic).
[00123] If frame 678 is configured to be self-evident and used as a balloon, frame 678 may have a burst pressure greater than 303.9 kPa (3 atm), more specifically, greater than 1,013.25 kPa (10 atm ), even more specifically, greater than 1,519.87 kPa (15 atm). If frame 678 is configured to be conspicuous and used as a balloon, frame 678 may have a diametrical elasticity of less than 0.35 mm / 101.32 kPa (1 atm), more specifically, less than 0.2 mm / 101 , 32 kPa (1 atm), even more specifically, less than 0.03 mm / 101.32 kPa (1 atm), even more specifically, less than 0.02 mm / 101.32 kPa (1 atm).
[00124] The housing wall 684 can have a high puncture resistance. For example, when a 678 housing is pressurized to about 405.3 kPa (4 atm) and a 1 mm gauge pin is propelled into the balloon at about 1 mm / s, the pin may need to exert more than 13 newtons of force to puncture the balloon wall, more specifically, more than 18 newtons. The housing wall 684 may be non-malleable. The housing wall 684 may have a polymer. Housing wall 684 may be impermeable (for example, not porous enough to prevent water and / or saline and / or air from being transferred or osmosis through housing wall 684). The housing wall 684 can have a wall thickness of about 0.04 mm to about 0.8 mm.
[00125] Figure 2A shows a housing 678 with a first, second and third housing taper reinforcements 862a, 862b and 862c, respectively, at proximal taper 34 and fourth, fifth and sixth housing taper reinforcements 862d, 862e and 862f , respectively, in the distal tapering. Each of the 862 housing taper reinforcements can be of different sizes, for example, different lengths. In addition, the carcass taper reinforcements 862a, 862b, 862c in the proximal taper 34 can be asymmetrical in relation to the carcass taper reinforcements 862d, 862e, 862f. For example, as shown in Figure 2A, the housing taper reinforcements 862a, 862b, 862c at the proximal taper 34 can be longer and / or can form a semicircle that has a greater curvature than the housing taper reinforcements 862d, 862e, 862f. In Figure 2A, the casing taper reinforcements 862 can be arranged so that a portion of each reinforcement 862 is visible. The carcass taper reinforcements 862 can cover part or all of the carcass taper 34 and 42, the rods 30 and 43 and the central section 38. The carcass taper reinforcements 862 can have carcass taper reinforcement shoulders 866. The carcass taper reinforcement shoulders 866 can have a semicircular shape and extend in the longitudinal direction of the carcass, as shown in Figure 2A. Carcass taper reinforcements 862 can increase the stiffness of carcass wall 684 in areas covered by carcass taper reinforcements 862. For example, either two or both neck sections 34 and / or 42 may be more rigid than the central section 38. The carcass taper reinforcements 862 may be panels 196. The wall 684 may comprise a polymer such as PET, Mylar, Nylon, Pebax, polyurethane or combinations thereof.
[00126] Figures 2B and 2D show a housing 678 with housing openings 714. Housing openings 714 can penetrate the entire wall of housing 678. Housing openings 714 can release internal pressure from housing 678 and may allow materials, such as blood or air, cross the plane of the housing wall 684. The housing openings 714 may be in fluid communication with the interior and exterior of the housing 678. The housing openings 714 may be circular (as shown in Figure 2D ), elliptical (as shown in Figure 2B), rectangular, drop-shaped, hexagonal or in other shapes or combinations thereof. The carcass openings 714 can be located in the carcass proximal rod 30, in the proximal tapering 34, in the central section 38, in the distal tapering 42 or in the carcass distal rod 43 or combinations thereof. There may be less than 500 openings 714 in housing 678, more specifically, less than 100, even more specifically, less than 25. For example, 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 openings 714 in housing 678.
[00127] As shown in Figures 2B and 2D, the housing openings 714 can be arranged in axial and circumferential rows, that is, to form a grid. For example, with reference to Figure 2D, openings 714 may be arranged along axial lines 5100A, 5100B, 5100C, 5100D and circumferential lines 5102A, 5102B, 5102C, 5102D. The openings 714 can be positioned in the cross section of each line 5100, 5102. There can be, for example, between two and six circumferential lines 102 at each end 34, 42 and between six and sixteen axial lines 5100. In one embodiment, there are twenty and four openings 714 at each end 34, 42 positioned along three circumferential lines 5102 at each end 34, 42 and along eight axial lines. Referring to Figure 2E and as discussed further in relation to Figure 7A, the openings 714 and / or axial lines 5100 can be positioned substantially between each outer pleat line 826 (and substantially along the inner pleat lines) to protect the openings 714 and prevent exposed walls from openings 714 from becoming trapped during delivery and removal of the balloon.
[00128] Figure 2C illustrates that the housing 678 may have drop-shaped housing openings 714 arranged along a single circumferential line at each end 34, 42 of the balloon. The housing openings 714 can be cut through housing taper reinforcements 862. The portion of the edge of the housing opening 714 that extends farther into the longitudinal center of the housing 678 can align with the reinforcement boss portion of carcass tapering 866 extending farther towards the longitudinal center of carcass 678 as shown in Figure 2C. In this way, the opening 714 can be aligned at an angle with the shoulder 866.
[00129] As shown in Figures 2F to 2I, other shape and configurations of aperture 714 are possible. For example, openings 714 can be shaped as squares (Figure 2H) or trapezoids (Figure 21) with rounded edges. In addition, as shown in Figures 2F to 2I, the openings 714 can be configured in such a way that they provide a maximum through-flow for a given space while still providing structural support. That is, while a drop shape can provide maximum throughflow while still folding inside the pleats at the conical ends of the balloon, a plurality of different openings along the same inner pleat line can provide substantially the same flow while provides additional structural support for the housing. For example, instead of having a single drop (as outlined in 714a), there may be a plurality of rounded openings 714b, 714c, a plurality of square openings 714d or a plurality of trapezoidal openings 714e. Each axial line 5100 (along the inner pleat line) can therefore include, for example, between 2 and 8 openings, such as between 3 and 4. In addition, as shown in Figures 2F to 2I, the openings can have a diameter increasing as they radiate from the base of the balloon, through the cone, towards the larger diameter.
[00130] In some embodiments, with reference to Figures 57A to D, the housing 678 may include a reinforcement 5700 that has a proximal tapering portion 5701 that covers the proximal tapering portion 34, a distal tapering portion 5702 that covers the tapering distal carcass 42 and strips 5703 extending between the proximal tapering portion 5701 and the distal tapering portion 5702. The proximal tapering portion 5701, the distal tapering portion 5702 and the strips 5703 can be produced from the same material , such as a thin film. The thin film can be a 196 panel or a layer 72. The thin film can be less than about 0.1 mm (0.004 inch) thick, more specifically, less than about 0.05 mm (0.002 inch) thick , even more specifically, less than about 0.03 mm (0.001 inch) thick.
[00131] Like the embodiment of Figure 2C, the proximal and distal tapering portions 5701, 5702 can include carcass taper reinforcement shoulders 866 rounded openings 714. A single strip 5703 can extend, for example, from each shoulder 866. As shown in Figure 57A, strips 5703 can travel approximately parallel to the longitudinal geometric axis of frame 678 and can connect a shoulder 866 in the proximal tapering portion 5701 to an opposite shoulder 866 in the distal tapering portion 5702.
[00132] In some embodiments, as shown in Figure 57A, strips 5703 can be approximately the same width. In other embodiments, as shown in Figure 57B, strips 5703 may have a variable width, such as narrow towards the center of housing 678 and wider at the proximal or distal ends.
[00133] In one embodiment, with reference to Figures 57C and 57D, reinforcement 5700 is formed in two separate patterns so that only a tapering portion (in this document, the distal tapering portion 5702) has strips 5703 connected to it while the other tapering portion (in this document, the proximal tapering portion 5701) does not include strips. Reinforcement 5700 can then be mounted on housing 678 so that strips 5703 are properly aligned (for example, so that strips 5703 extend from the shoulders 866 of the distal tapering portion 5702 to the shoulders 866 of the proximal portion 5701 without overlap). In some embodiments, each strip 5703 may have a curved section 5707 close to its proximal end so that the edge 5705 of the strip meets the proximal portion 5701 at an angle. The curved section 5707 advantageously reduces the possibility that the edges 5705 of strips 5703 will become trapped during the removal of an inflatable medical device, including housing 678, from a patient. As will be further shown in Figures 57C and 57D, strips 5703 can include slits or cuts 5709 in them, as well as a plurality of cuts 5709 along the length of each strip 5703. Each cut 5709 can extend approximately perpendicular to the length the strip. The cuts 5709 can advantageously allow the strips 5703 to be more flexible, thus allowing the strips 5703 to bend more easily to conform to the surface of the housing 678.
[00134] Reinforcement 5700, including proximal tapering portions 5701, distal tapering portions 5702 and strips 5703 between them, can advantageously provide additional longitudinal stiffness to frame 678. Such additional stiffness can help prevent torsion of the housing 678 under compression, which may otherwise be caused due to asymmetric loading on the housing 678. In addition, strips 5703 can advantageously provide a smooth transition from the unreinforced area to the reinforced area of the housing 678 during removal of a patient's device. For example, the pull force through a standard introducer of an inflatable medical device that includes housing 678 without 5703 straps can be greater than 1.81 kgf (4 lbs), such as 2.04 kgf (4.5 lbs) ). Such high strength can potentially require the removal of the introducer and / or cause damage to the vessels. On the other hand, the extraction force with the 5703 strips can be reduced to less than 0.91 kgf (2 lbs), such as between 0.68 and 0.86 kgf (1.5 and 1.9 lbs), for example. for example, 0.77 kgf (1.7 lbs) or 0.82 kgf (1.8 lbs). The extraction force can therefore be decreased by a factor of more than 2 by including the 5703 strips. Such a low extraction force can reduce the likelihood of damage to the vessels during use.
[00135] Alternative standards for reinforcement 5700 are possible. For example, as shown in Figures 57E and 57F, reinforcement 5700 is formed in two separate patterns, so that only a tapering portion (in this document, the proximal tapering portion 5802) has strips 5703 connected through it, while the other tapering portion (in this document, the distal tapering portion 5801) does not include strips. Having the 5703 strips on the proximal side can advantageously assist in introducing and extracting the balloon from the introducer. Each portion 5801, 5802 may include radiant grooves 5881 on the base to assist portions 5801, 5802 to wrap around the base of the balloon. Each of the strips 5703 can have a distal tapering portion 5819 configured to fit notches 5817 in the portion 5801.
[00136] Although shown in Figures 57A and 57B extending along the outside of the balloon, reinforcement 5700 may extend under or inside one or more of the balloon layers. For example, with reference to Figure 57G, reinforcement 5700 can be placed directly over a bladder 52 formed over a mandrel 230. As shown in Figure 57H, successive fiber layers can then be placed over it to cover the reinforcement 5700. Covering the 5700 reinforcement with one or more layers advantageously keeps the 5700 reinforcement in place and prevents the 5700 reinforcement from getting stuck throughout the patient's anatomy when the device is in use.
[00137] Figures 3A, 3B, 3C and 3D illustrate that frame 678 may have reinforcement fibers 86. The second or second reinforcement fibers or latitudinal reinforcement fibers 86a may be perpendicular to the longitudinal geometric axis of carcass 26. The fibers 86a can be a continuous fiber woven around the part (a "loop winding"). The fibers can be applied with a certain density. For example, fibers can be applied to 100 windings per 25.4 mm (1 inch). The number of windings per inch (25.4 mm) is often called the "pitch" of the winding. The pitch may vary over the length of the housing. The fibers 86a can be omitted completely from the portions of the housing 678.
[00138] The first longitudinal reinforcement fibers or reinforcement fibers 86b can be parallel to the carcass 26 longitudinal axis. The fibers can be applied with a certain density. For example, there may be 50 fibers 86b by 25.4 mm (1 inch) around the circumference of the housing 678. The density of fiber 86b may vary around the circumference of the housing. The fibers 86b can be omitted completely from the portions of the housing 678.
[00139] The angle between fibers 86a and 86b can be approximately perpendicular and may not be changed between inflation and deflation.
[00140] Figures 3A, 3B, 3C and 3D show that the housing can have a longitudinal proximal zone 618a, a central longitudinal zone 618b and a distal longitudinal zone 618c. The proximal zone 618a can cover the proximal taper 34 and the proximal stem 30. The distal zone 618c can cover the distal taper 42 and the distal stem 43. The central zone 618b can cover the central section 38. The fibers 86a and / or 86b they may be present or absent in zones 618a and / or 618b and / or 618c. The fiber pitch 86a may be different in each of zones 618a, 618b and 618c. The fiber pass 86a can vary in each of zones 618a, 618b and 618c. The fiber density 86b can be different in each of zones 618a, 618b and 618c. The fiber density 86b can vary in each of the zones 618a, 618b and 618c.
[00141] Figure 3A shows that fibers 86a and 86b may be present in zone 618b. Fibers 86a and 86b may not be present in zones 618a and 618c. Figure 3B shows that fibers 86b may be present in zones 618a, 618b and 618c. The fibers 86a can be present only in zone 618b. Figure 3C shows that fibers 86b and 86a can be present in zones 618a, 618b and 618c. Figure 3D shows that the pitch of fibers 86a in zone 618b may be less than the steps in zones 618a and 618c. The steps in zones 618a and 618c can be substantially equivalent. For example, the pitch in zones 618a and 618c can be 128 windings per inch (25.4 mm), while the pitch in zone 618b can be 100 windings per inch (25.4 mm). Low pitch fibers 86 in zone 618 can cause the carcass wall to structurally fail in low pitch zone 86 before step 86 zones with an upper fiber pitch. In the above example, zone 618b may break before zones 618a and 618c when the housing wall 684 experiences a structural failure. Zones 618 with a lower pitch may be more malleable and collapsible than zones 618 with a higher pitch. A zone 618 may have a pitch 10% less than the remainder of the part, more specifically, a pitch 20% less than the remainder of the housing wall 684.
[00142] The boundaries between zones 618a and 618b and between 618b and 618c can move. For example, the boundaries may be located at frame tapers 34 or 42 or at center section 38. Second reinforcement fibers, latitudinal reinforcement fibers 86a may or may not be a single continuously wound fiber.
[00143] Figure 4 illustrates that the first reinforcement fiber 85a can be at a first angle of the reinforcement fiber with respect to the longitudinal axis of the frame 26. For example, the first angle of the reinforcement fiber can be 10, 15, 20, 25, 50, 55 or 60 degrees in relation to the longitudinal geometric axis of the carcass. The second reinforcement fiber 85b can be at a second angle of the reinforcement fiber with respect to the longitudinal axis of the housing 26. For example, the second angle of the reinforcement fiber can be 10, 15, 20, 25, 50, 55 or 60 degrees in relation to the longitudinal geometric axis of the carcass. The second reinforcement fiber 85b may have an equal angle, however, opposite to the first reinforcement fiber 85a. For example, the first reinforcement fiber 85a can be at +20 degrees and the second reinforcement fiber 85b can be at -20 degrees with respect to the longitudinal carcass axis. The third reinforcement fiber 85c can be substantially perpendicular to the longitudinal carcass axis. The third reinforcement fiber 85c can be omitted from the casing wall 684.
[00144] Figure 5 illustrates longitudinal reinforcement fiber 86b may be parallel to the longitudinal axis 26. The second longitudinal reinforcement fiber 87b may be parallel to the longitudinal axis 26. Fibers 86b and 87b they can be separated by areas without longitudinal fiber 614. Areas 614 can separate fibers 86b and 87b by 2 mm, more specifically, less than 1 mm, even more specifically, less than 0.25 mm. Areas 614 can be distributed over the carcass surface so that no area substantially overlaps substantially any other area over the carcass. Areas 614 can be distributed so that adjacent latitudinal areas do not have any longitudinal overlap. Areas 614 can be distributed in a regular repeating pattern around the diameter of the shell enough to prevent any fiber from extending from one end of the shell to the other while still maximizing the longitudinal strength of the shell. Fibers 86B and 87B require less than 80% of the carcass length, more specifically, less than 75%, even more specifically, less than 70%, even more specifically, less than 65%, even more specifically, less than 60% . The second reinforcement fibers or latitudinal reinforcement fibers 86a can be substantially perpendicular to the carcass longitudinal axis 26.
[00145] Figure 6 illustrates that the longitudinal reinforcement fiber 86b can be parallel to the longitudinal geometry axis 26. The second longitudinal reinforcement fiber 87b can be parallel to the longitudinal geometry axis 26. The fibers 86b and 87b can overlap in the reinforcement fiber overlapping area 612. The reinforcement fiber overlapping area 612 can form a ring-shaped area that can completely circle the central section 38.
[00146] Figure 7A illustrates that a housing 678 can be pleated to form ribs 84, for example, four, five, six, seven or eight ribs 84, such as the first rib 84a, the second rib 84b. The grooves 84 can be produced from accordion pleats, box pleats, cartridge pleats, grooved pleats, honeycomb pleats, blade pleats and plies, laminated pleats or combinations thereof. The pleating can be formed by heat and / or pressure and / or the reinforcing fibers and / or panels can be oriented to form the grooves 84. The pleating of frame 678 can create a first line of internal pleat 822a and a second line of pleat inner pleat 822b and outer pleat lines 826a between inner pleat lines 822a and 822b. Pleat lines 822 and 826 can be areas where the casing wall 684 can be furrowed. The inner pleat lines 822 can be positioned radially into the outer pleat lines 826 when the housing is folded as shown in Figure 7A. Each groove 84 can be a portion of the casing wall 684 between two inner pleat lines 822. The housing openings 714 can be between adjacent outer pleat lines 826 and interrupt an inner pleat line 822 as shown. Openings 714 may or may not cross an internal pleat line 822. Openings 714 may or may not cross an external pleat line 826.
[00147] Figure 7B illustrates a D-D sectional view of Figure 7A. The section of the sectional view showing aperture 714 is highlighted with a dotted line. The width of the opening 714 in the cut DD can be divided into the first partial width of the opening 830 and the second partial width of the opening 834. The first partial width of the opening 830 can be approximately equal to the second partial width of the opening 834. For example, the opening 714 can be centered on the inner pleat line 822. The first partial width of the opening 830 may be different from the width 834, for example, equal to one or three times the width 834, therefore, placing the opening 714 outside the center of the opening line. inner pleat 822. Opening 714 may be completely between two adjacent outer pleat lines 826, for example, between outer pleat lines 826a and 826b.
[00148] Figure 7C illustrates an E-E sectional view of Figure 7A. The central area of the housing may have openings or no openings (as shown) that interrupt the housing wall 684, as shown in section E-E.
[00149] Figure 7D illustrates that the pleated housing 678 or annular balloon structure 682 can be folded so as to take on a compact form with a reduced diameter. Pleating can allow frame 678 or frame 682 to be folded and expanded in a repeatable and regular manner. In such a folded state, the openings 714 can be completely (as shown) or partially covered or hidden by flattened ribs 84, for example, the second rib 84b can cover or hide the opening 714. The cover of the openings 714 can provide the flattened housing 678 or the annular balloon 682 an external surface free from interruptions of the openings 714. The diameter of the structure can be minimized and the openings can be covered by the structure surface before and during the insertion of the structure into the body during a medical procedure.
[00150] Figures 58A to D illustrate a sectional view of a housing 678 having reinforcements 5700 (including a proximal tapering portion 5701, a distal tapering portion 5702 and strips 5703 as discussed above in relation to Figures 57A to D ). As shown in Figures 58A to D, strips 5703 can be configured so that they are aligned with the grooves 84 and / or are completely aligned between the inner and outer fold lines 822, 826. For example, as shown in Figures 58A, 58B and 58D, all strips 5703 can be positioned on a single side of each groove 84 and all can face the same direction (clockwise in Figures 58A to 58B and counterclockwise in Figure 58D). In some embodiments, strips 5703 can be located only on the convex surfaces of the grooves 84 (as shown in Figures 58A to 58B) while in other embodiments, strips 5703 can be located only on the concave surfaces of the grooves 84 (as shown in Figure 58D ). In some embodiments, strips 5703 may be located on both sides of each groove 84 (as shown in Figure 58C). Each of the strips can have a width that is between 10 and 95% of the width of the groove 84 (i.e., the length from the inner pleat line 822 to an outer pleat line 826), such as between 20 and 85% the width of a streak 84, for example, between 30 and 75%. Thus, in some embodiments (shown in Figures 58 A, 58C and 58D), strips 5703 may have a width that is substantially less than the width of a groove 84. In other embodiments, strips 5703 may have a width that is approximately equal to the width of a groove 84 (as shown in Figure 58B). In some embodiments, strips 5703 may be closer to the outer pleat line 826 than to the inner pleat line 822 (as shown in Figures 58A and 58C) or may be closer to the inner pleat line 822 of the than to the outer pleat line 826 (as shown in Figure 58D). Finally, strips 5703 can be substantially centered between an outer pleat line 826 and an inner pleat line 822 (as shown in Figure 58B). Although shown in Figures 58A to 58D as positioned along the outer surface of the balloon, strips 5703 can also be located under or within one or more layers of the balloon as shown in Figure 58E), such as under one or more layers fiber. For example, strips 5703 can be positioned between the bladder and the layers of fiber. Placing the 5703 strips under fibers can advantageously help to capture the 5703 strips to help prevent the 5703 strips from extending out of the balloon and / or getting caught in a patient's anatomy during use.
[00151] Placing strips 5703 between pleat lines 822, 826 can advantageously provide memory and repeatability for folding of frame 678. That is, strips 5703 arranged between pleat lines provide tighter folding and refolding , more compact and more concise of a 678 housing compared to a 678 housing without the 5703 strips.
[00152] The annular balloon structure 682 can be subjected to a first cycle and a second cycle of inflation and deflation. The annular balloon structure 682 can have the same amount of pleats after the first and second cycles of inflation and deflation. For example, the angle of the pleat fold position and the amount and location of the pleats may remain approximately constant after a cycle of inflation and deflation.
[00153] A material, such as a gas or a liquid, can flow from the outer housing 49 through the housing openings 714 over a housing taper (for example, the distal taper 42), pass through the inner housing 47 and flow out of the housing openings 714 over the other housing taper (for example, proximal tapering 34) to the outer housing 49. Figure 8 shows that openings 714 can be fitted with one-way flow opening valves or flow valves housing 718, for example, the openings 714 can be fitted with the housing opening flaps 718 on the proximal taper 34. The housing opening flaps 718 can be configured so that they partially or completely cover the openings 714 in which there is no material flowing through the inner shell 47 to the proximal end, for example, from the outer shell 49. When the material is propelled to flow with sufficient pressure from the inner shell or 47 for the outer housing 49, the flaps 718 can open to allow flow through the openings 714. When the pressure is reduced or removed, the flaps 718 can partially or completely cover the openings 714. The flaps 718 can act with valves one way or two way. For example, the flow and flow pressure (for example, of a body fluid, such as blood) through the openings 714 can be generated by a heartbeat during a medical procedure. Flaps 718 can be a temporary or permanent replacement for a heart valve (such as the aortic valve) during a medical procedure. The flaps can be produced from a polymeric film or produced in a manner similar to the carcass wall 684 described herein or produced from a malleable material, such as, for example, an elastomer. The flap can be produced integrally to the housing by cutting the opening 714, however, in order to omit the circumferential cut, for example, in order to leave a hinge 719.
[00154] Figure 9A shows a pattern for a marker wire 190. The marker wire 190 can be wrapped around the housing 678. The marker wire 190 can partially cover the distal and proximal ends of the central section 38 of the housing 678.
[00155] Figure 9B shows that the marker wire 190 can be wrapped around the housing in both the distal taper 42 and the proximal taper 34 of the housing 678. The marker wire 190 can be wrapped around the distal and proximal edges of the center section 38 without that no substantial amount of yarn is placed in the center section 38. The marker yarn can be wound in a helix pattern in both directions on the housing or be wound in a single direction. The crossing angle of the marker wire 191 between two layers of the marker wire can be less than 20 degrees, more specifically, less than 10 degrees, even more specifically, less than 6 degrees.
[00156] Figure 9C illustrates that frame 678 may have a marker wire 190 wound over approximately the entire length of the center section 38. The marker wire 190 may be centered on the center section 38. The marker wire 190 may cover only a portion of the central section 38. For example, marker wire 190 can cover more than 70% of the central section 38, more specifically, more than 80%, even more specifically, more than 90%. Marker wire 190 can cover a portion of distal bottlenecks 42 and proximal bottlenecks 34. For example, marker wire 190 can cover 100% of distal bottlenecks 42 and proximal bottlenecks 34, more specifically, more than 50%, even more specifically, more 25%. The marker wire 190 may be a latitudinal reinforcement fiber 86a.
[00157] Figure 9D illustrates that the housing 678 may have a marker wire 190 wound over substantially the entire length of the housing 678.
[00158] The pitch of the marker wire 190 can be less than about 150 windings per 25.4 mm (1 inch), more specifically, less than about 75 windings per 25.4 mm (1 inch), even more specifically, less than about 25 windings per 25.4 mm (1 inch), even more specifically, less than about 10 windings per 25.4 mm (1 inch). The pitch of the marker wire 190 can be about 6, 5, 4, 3 or 2 windings per 25.4 mm (1 inch).
[00159] Figure 10A illustrates that the carcass wall 684 in section B-B or in other sections obtained through a single carcass wall can have a layer 72 which 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 can comprise a layer 72 or a panel 196.
[00160] The reinforcement fiber 85, 86 and 87 can be a monofilament 274 and / or a bundle 270. A bundle 270 can contain one or more monofilaments 274. The reinforcement fiber 86 can be a marker wire 190. A matrix of The fiber may have one, two or more reinforcement fibers 86 that remain substantially parallel to each other and embedded in an adhesive 208. The substantially parallel reinforcement fibers 86 may be positioned within the adhesive so that they touch one another along its length. The substantially parallel reinforcement fibers 86 can be positioned so that there is an adhesive separating each fiber along its length.
[00161] Figure 10A illustrates a layer 72 with a fiber matrix having a layer width 210 in cross section. Layer width 210 may include several monofilaments 274. Layer 72 may have a fiber density of linear quantity measured, for example, as the quantity of fibers 86 per unit of layer width 210. Fiber density of linear quantity may be equal to or greater than about 500 274 monofilaments per inch (25.4 mm), more specifically, equal to or greater than about 1,000 274 monofilaments per inch (25.4 mm), more specifically, equal to or greater than about 2,000 274 monofilaments per inch (25.4 mm), even more specifically, equal to or greater than about 4,000 274 monofilaments per inch (25.4 mm). For example, the density of linear quantity monofilaments 274 can be from about 1,000 monofilaments 274 per inch (25.4 mm) to about 2,000 monofilaments 274 per inch (25.4 mm).
[00162] Layer 72 with a fiber matrix can have a layer 216 thickness of about 1 μm (0.00004 inch) to about 50 μm (0.002 inch), more specifically, about 8 μm (0, 0003 inch) to about 25 μm (0.001 inch), even more specifically, from about 10 μm (0.0004 inch) to about 20 μm (0.0008 inch). Monofilaments 274 or fibers 86 may have a non-circular cross-section, for example, an oval cross-section.
[00163] A part or all of the carcass wall 684 may have a quantitative volumetric density of monofilaments 274 measured, for example, as the quantity of monofilaments 274 per unit area. The density of area quantity monofilaments 274 can be equal to or greater than about 100,000 274 monofilaments per square inch (25.4 mm2), more specifically, equal to or greater than about 250,000 274 monofilaments per square inch, more specifically, equal or greater than about 1,000,000 274 monofilaments per square inch, even more specifically, equal to or greater than about 4,000,000 274 monofilaments per square inch (25.4 mm2). The amount of fiber area can be about 25% of the area of a wall cross section, more specifically, about 50%, more specifically, about 75%.
[00164] The ratio of the volume of a fiber matrix to the volume of the 274 monofilaments can be approximately equal to or greater than about 15%, more specifically equal to or greater than about 30%, more specifically, equal to or greater than about 50%, even more specifically, equal to or greater than about 75%.
[00165] Figure 10B illustrates that the outer layer 72a and the inner layer 72b can be polymeric films, for example, as described below. In any variation, the polymeric films can be the same or different polymers or any combination thereof. The first middle layer 72c may have a fiber matrix, for example, with the fibers oriented as longitudinal fibers 86b. The second middle layer 72d may have a fiber matrix, for example, with the fibers oriented as latitudinal or loop fibers 86a. The third middle layer 72e can be an adhesive. The fourth middle layer 72f may be a radiopaque layer, such as a wire or sheet of metallic paper. In some embodiments, layers 72c, 72d, 72e may be of varying lengths to provide a smooth transition to the main diameter (for example, as shown in Figure 11B, layer 72c may be longer than layer 72d, which may be longer longer than layer 72e). In some embodiments, layers 72c, 72d, 72e can be a single layer, such as a single layer of film.
[00166] Figure 11A is a cross-section obtained in C-C in Figure 3C. Figure 11A illustrates that the outer layer 72a and the inner layer 72b can be polymeric films, for example, as described below. The first middle layer 72c may have a fiber matrix, for example, with the fibers oriented as longitudinal fibers 86b. The second middle layer 72d may have a fiber matrix, for example, with the fibers oriented as latitudinal or ring fibers 86a. The third middle layer 72e, the fourth middle layer 72f and the fifth middle layer 72g can be tapered carcass reinforcements 862. The tapered carcass reinforcements can have uneven longitudinal lengths as shown in Figure 11A. An adhesive can be placed between any of the layers 72 shown. Any of the layers 72 shown in Figure 11A can be omitted.
[00167] As shown in Figure 11A, proximal taper 34 or distal taper 42 can have a first medium wall thickness 686a. The central section 38 can be a second medium wall thickness 686b. The first average wall thickness 686a can be greater than the second average wall thickness 686b.
[00168] The carcass wall 684 of the proximal tapering 34 and / or distal tapering 42 can be equal or more rigid per unit area than the carcass wall 684 of the central section 36. For example, the carcass wall 684 of the tapering proximal 34 and / or distal tapering 42 may have a measured bending stiffness of about two, about three or about five times greater per unit area than the carcass wall 684 of the central section 36.
[00169] Figure 11B is a cross-section obtained in C-C in Figure 3C. Figure 11A illustrates that the tapered reinforcements of carcass 862 can be placed closer to the inner layer 72b than to the outer layer 72a.
[00170] Layer 72 may be a panel 196. Layers 72 and / or panels 196 may comprise a polymer. The polymer can be a film. The thickness of the polymeric films can be from about 2 m to about 50 μm, more specifically, from about 2 μm to about 18 μm, even more specifically, from about 4 μm to about 12 μm. The films can be metallized or coated to change their surface properties. Metallization or coating can occur before or after a film is formed. The films can be treated chemically or through plasma or through corona treatment or through combinations of them in order to modify their binding capacity. A layer 72 and / or a panel 196 and / or a film may comprise polyamide, copolyamide, polyester, copolyester, ECTFE, Solef, EPTFE, FEP, Kapton, Pebax, HDPE, LDPE, PET, Mylar, micrton, nylon, PEEK, PEN (naphthalene polyethylene), Tedlar, PVF, Polyurethane, Thermoplastic Polyurethane (TPU), Parylene or combinations thereof.
[00171] The reinforcement fibers 86 can be of high resistance and non-elastic. Non-elastic fibers can have a deformation to failure less than 10%, more specifically, less than 5%. High-strength fibers can have a major tensile strength greater than 1.8 GPa (260 ksi), more specifically greater than 2.4 GPa (350 ksi), even more specifically, greater than 2.9 GPa (420 ksi) .
[00172] Reinforcement fibers 86 can have a fiber diameter or monofilament 212, for example, from about 1 μm to about 50 μm, for example, less than about 25 μm, more specifically, less than about 20 μm.
[00173] The reinforcement fibers 86 can be a thread or threads. Reinforcement fibers 86 can be a metal. The wire can have a deformation to failure less than 10%, more specifically, less than 5%, even more specifically, less than 2%. The wire can be annealed or tempered to adjust its mechanical properties. The wire may have a breaking strength greater than 1.03 GPa (150 ksi), more specifically, greater than 1.72 GPa (250 ksi), more specifically, greater than 2.75 GPa (400 ksi).
[00174] The wire can be ductile and have a deformation to failure greater than 20%, more specifically, greater than 40%, even more specifically, greater than 80%. The ductile wire can allow the 678 housing to be bent without fracturing the wire.
[00175] The wire can be less than 25 μm in diameter. The wire can be substantially rectangular and less than 25 μm thick 1068, more specifically, less than 15 μm thick 1068 when integrated into the balloon wall. The ratio of the wire width 1072 to the wire thickness 1069 can be greater than or equal to about 3, more specifically, greater than or equal to about 5, more specifically, greater than or equal to about 10. The wire can be a metal foil in which the ratio of the wire width 1072 to the wire thickness 1069 can be greater than or equal to about 100, more specifically, greater than or equal to about 300, more specifically, greater than or equal to about 500. A yarn density can be greater than about 2.4 g / cmA3, more specifically, greater than about 6.9 g / cmA3, more specifically, greater than about 15 g / cmA3.
[00176] The reinforcement fiber 86 or yarn can be substantially radiopaque when used under a fluoroscope as a part of a medical procedure on the human body. The use of radiopaque material, such as radiopaque fibers 86, may allow the physician to use an inflation medium, such as a saline solution, which is not radiopaque when inflating a 650 balloon or a 682 annular balloon structure. radiopaque, such as radiopaque fibers 86, can allow the physician to see how well pleated or folded the balloon structure 682 is when placed in the human body. The fibers 86 can be substantially radiolucent. A fiber matrix can have the same size and material or different sizes and materials as the fibers 86 in the same fiber matrix.
[00177] Reinforcement fibers 86 or threads can be coated. The coating can intensify adhesion. The coating can be an adhesive 208. The adhesive 208 can be melted as a part of the process for applying the reinforcement fibers 86 to a housing 678.
[00178] 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, Ceramics, 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 example, 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.
[00179] Adhesive 208 can be a thermoset material, a thermoplastic material or a combination thereof. Adhesive 208 can be elastomeric. The adhesive 208 can be a polymer or a monomer or combinations thereof. 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.
[00180] Any of the layers 72 or panels 196 can be leak-proof, waterproof, airtight, resistant to MMA (methyl methacrylate), MMA release or combinations thereof.
[00181] Magnetic resonance visualization enhancement materials, such as magnetic contrast agents, can be added to adhesive 208 or any layer 72 or panel 196. Magnetic resonance visualization enhancement materials can enhance balloon visualization during a magnetic resonance imaging (MRI) procedure. For example, the MRI visualization enhancement material can be gadolinium, Omniscan, Optimark, ProHance, Magnevist, Multihance or combinations thereof.
[00182] Any of the layers 72, for example, the outer layer 72a, can be painted or dyed a color of visible spectrum. 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 678 housing.
[00183] The color can be selected for brand development, market differentiation, as an indication of the type of device, the size of the device or combinations thereof. For example, devices that have a selected diameter, length, pressure rating, efficacy or clinical indication or other common performance metric, or combinations thereof, can be ringed in a specific color (for example, green for a first type of device , red for a second type of device).
[00184] Layers 72 may have one or more optical fibers. The optical fiber can be a deformation sensor. The deformation sensor can monitor the mechanical situation in real time. Fiber optics can guide the delivery of light to the body. The optical fiber can visualize a target location (for example, gathering light from the body to produce the visual image).
[00185] Figure 11 C is an exemplary cross-section of an area of the balloon shown in Figure 57H that does not have a reinforcement 5700 whereas Figure 11D is an example cross-section of an area of the balloon shown in Figure 57H that has an reinforcement 5700. Referring to Figures 11C and 11D, the outer layer 72a and the inner layer 72b may include a polymer film, such as polyether ether ketone (PEEK). The outer layer can be a vapor deposited layer. The outer layer 72a can be on a first adhesive layer 208a, such as thermoplastic polyurethane (TPU). Below the first adhesive layer 208a may be a first intermediate layer 72c composed of a fiber matrix, for example, with fibers oriented as latitudinal or arc fibers 86a in an adhesive 208b or resin, such as TPU. The first intermediate layer 72c can be on a second intermediate layer 72d composed of a fiber matrix, for example with fibers oriented as longitudinal fibers 86b in an adhesive 208c. Referring to Figure 1 ID, reinforcements 5700 may include a polymer film 5777, such as PET film, between adhesive 208d, e.g. Reinforcements 5700 can be positioned between the inner layer 72b and the second intermediate layer 72d.
[00186] Figure 12 shows that a balloon 650 may have a main balloon diameter 662, a balloon length 666 and a balloon wall thickness 658. The balloon may have a tapered balloon section 652 at either end. The tapered sections can connect the balloon diameter to the balloon inflation / deflation ports 654. The balloon 650 can be inflated by placing a pressurized fluid, such as saline, contrast, water or a gas, on both inflation ports. / deflation or putting up fluid and one of the inflation / deflation ports 654 while closing the other inflation / deflation ports 654.
The balloon 650 may have a main diameter 662 of about 1 mm to about 15.3 mm, more strictly about 4 mm to about 12 mm, even more strictly about 6 mm to about 10 mm. The balloon wall thickness 658 can be about 5 μm to about 50 μm, more strictly about 8 μm to about 25 μm, even more strictly about 8 μm to about 15 μm. The balloon length 666 can be about 125 mm to about 635 mm, more strictly about 200 mm to about 500 mm, even more strictly about 250 mm to about 380 mm.
[00188] Figure 13 shows that balloon 650 may have balloon segments 656a through 656f. Balloon segments 656a to 656f can form a lumen of continuous internal inflation / deflation. Each balloon segment 656 can be joined by a balloon flexion section 670a to 670e to the adjacent balloon segment 656. The balloon flexion sections 670 can have a balloon flexion section diameter 664 smaller than the main balloon diameter 662 (i.e., balloon segments 656). Balloon 650 may have a balloon bending section diameter 664 of about 1 mm to about 10 mm, more strictly about 2 mm to about 6 mm, even more strictly about 2.5 mm to about 5 mm. Balloon 650 may have a balloon bending section diameter 664 of about 3.3 mm. The multi-segment balloon tapered section 653 can connect balloon bending sections 670 to balloon segments 656. Balloon 650 can bend or flex in balloon bending sections 670 before bending into balloon segments 656, for example, when balloon 650 is inflated. Balloon 650 may have 4, 5, 6, 7, 8, 9, 10 or more balloon segments 656.
[00189] The 650 balloon can be made of a polymer or use several layers or a mixture of different polymers. Polymers such as Nylon, PEBAX, PET, parylene and / or polyurethane can be used to form the 650 balloon. The 650 balloon can be manufactured by blow molding. The balloon may comprise a layer 72, a panel 196 or a film as described above.
[00190] A heat-shrink tubing can be used to form balloon 650. For example, balloon 650 can be formed by placing the heat-shrink tubing on a removable mandrel, heating the tubing and then removing the mandrel. The mandrel can be removed mechanically, with a solvent such as water, by applying heat or combinations thereof.
[00191] The 650 balloon can be formed by depositing a material either on a mandrel or in a cavity mold. The mandrel can be removed as described above or a mold can be opened to remove the 650 balloon. Deposition can be through various sets of physical vapor deposition, immersion, coating or spray procedures. Parylene can be deposited using a physical vapor deposition process. Balloon 650 can be deposited directly on a mandrel with the shape shown in Figures 15, 16, 17 and 18. The mandrel can then be removed.
[00192] The balloon may comprise a fiber and be designed and manufactured as described in Provisional Order No. 61 / 363,793, filed July 13, 2010, and in PCT Order in PCT / US2011 / 43925, filed July 13, 2011, in that both are incorporated by reference in this document in their entirety.
[00193] Figure 14A shows a balloon with balloon restrictions 674 wrapped around the length of balloon 650. Figure 14B shows a balloon with balloon restrictions 674 wrapped around the lengths of the balloon. Balloon restrictions 674 can be attached to the outside of the balloon. Restrictions 674 can be tied or tied around the balloon. Balloon constraints 674 can serve to narrow and join the balloon where they are applied, thus creating a 670 balloon flexion section. A 670 balloon flexion section can also be created by locally twisting the balloon.
[00194] Figures 15 and 16 show a balloon 650 after balloon segments 656 have been formed in an annular balloon structure 682 and inflated. The balloon segments can form a ring with a hollow or free channel or path in the center. The annular working length of the balloon structure 680 can be almost equal to the longitudinal length of the constant section of the larger diameter of each balloon segment 656. The working length 680 can be about 12 mm to about 100 mm, more strictly about 25 mm to about 75 mm, even more strictly 32 mm to 65 mm. The working length 680 can be about 45 mm. The balloon segments 656 can be attached to each other with adhesive, solvent, the application of heat or combinations thereof. Figure 15 shows that the local balloon diameter of the flexed or relaxed (i.e., relaxed) flexion section 670 can be smaller than the main balloon diameter of the balloon segments 656. Figure 16 shows a flexion section 670 where the balloon was curved or bent with no previous narrowing of the balloon diameter. The balloon can be inflated by placing pressure on the balloon inflation / deflation ports 654a and 654b. Inflation / deflation ports 654a and 654b can be joined into a single inflation / deflation port.
[00195] A first balloon segment 656a may have a first longitudinal axis of balloon segment 657a. A second balloon segment 656b may have a second longitudinal axis of balloon segment 657b. A balloon segment longitudinal geometric angle 659 can be the angle between the first balloon segment longitudinal axis 657a and the second balloon segment longitudinal geometric axis 657b. A longitudinal geometric angle of balloon segment 659 can be zero degrees to 200 degrees, more strictly, 160 degrees to 200 degrees, for example, 180 degrees. The angle of the longitudinal geometric axis 659 can be the angle formed by the opposite end ends of the balloon bending section 670 adjacent to the respective balloon segments 656.
[00196] Figure 17 shows a group of 650 inflated balloons arranged in a 682 annular balloon structure. Rather than sharing an inflation / deflation lumen, each balloon has two inflation / deflation ports 654. Figure 18 shows a design balloon with an inflation / deflation port and the other end closed. The balloon in 8B can be arranged in an annular balloon structure 682 similar to that shown in Figures 15, 16 and 17. Balloons 650 can have their interior volumes connected together by punching or punching holes in the wall of each balloon and then aligning the holes in each balloon before connecting the 650 balloons together.
[00197] Figure 19 shows a method of forming the 650 balloon in an annular space. The adhesive 208 or a solvent can be applied to the outside of the flask. Balloon 650 can be screwed around pines 676. Balloon flexing section 670 can be twisted around the balloon longitudinal geometric axis, for example, 45 or 90 degrees. A fixing device, for example, a compression sleeve of a balloon mounting fixture 898 (for example, a non-stick tube such as that fluorinated ethylene propylene compound (FEP), such as Teflon) can be slid over the balloon 650 in order to radially retain and compress the balloon segments 656 together. The compression sleeve of the balloon mounting fixture 898 may have an inner diameter smaller than the outer diameter of the annular balloon structure 682 shown, for example, in Figures 15, 16 or 17. A cross-section of the balloon 650 in the sleeve 898 balloon mounting fixture compression plate may look similar to Figure 24B with housing 678 being replaced by the 898 balloon mounting fixture compression sleeve. Heat can be applied to cure adhesive 208 or to melt or merge the 656 segments together.
[00198] Figure 20A shows a balloon 650 after being formed into a spiral to produce an inflated annular balloon structure 682. That is, balloon 650 forms a spiral ring with a central fluid passage 692 in the center. The spiral coils can be attached to each other with adhesive, solvent, the application of heat or combinations thereof. The balloon can be inflated by placing pressure on the balloon inflation / deflation port 654. Multiple spiral coils can be interleaved to form an annular balloon structure.
[00199] Figures 20B and 20C show a spiral forming tool 742. The spiral forming tool has a spiral groove 746. A nominally straight balloon 650 can be rolled into the spiral groove and pressurized. The pressurized assembly can be placed in the oven. The balloon dimensions can move gradually until the balloon has been formed in the spiral shown in 11a.
[00200] Figure 21 shows that balloons 650 can have toroidal configurations. Balloons 650 can be stacked to produce an annular balloon structure 682. Balloons 650 can form a ring with a free path in the center. The 650 balloons can be attached to each other with adhesive, solvent, the application of heat or combinations thereof. Balloons 650 can be inflated by placing pressure on balloon inflation / deflation port 654 (not shown). The lumens of each balloon 650 can be in fluid communication with one or more (for example, all) of the other lumens and connected to one or more (for example, all) of the other lumens internally.
[00201] Figures 22A and 22B show that balloon 650 can be attached to a strip of balloon 672. Balloon 650 can be in a spiral configuration. Balloon band 672 can be removed during a medical procedure so that balloon 650 can unwind along the first hollow axis 2000a. This can make it easy to extract the 650 balloon through an introducer after a procedure.
[00202] An annular balloon structure can comprise a balloon 650 and a housing 678.
[00203] Figure 23A shows that the inflated annular balloon structure can have a housing 678. Housing 678 can wrap, wrap or surround balloon segments 656. Housing 678 can cover all or part (as shown) of the housing segments. balloon 656.
[00204] Figure 23B shows a cross-section F-F through the center of the inflated annular balloon structure 682 in Figure 23A. The annular balloon structure 682 can have a central fluid passage 692 which can allow the annular balloon structure 682 to perfuse when used in a lumen in the body. The annular balloon structure 682 can have an inner radius 690. That inner radius 690 can be ^ of the maximum circular diameter that can pass through the central fluid passage 692 of the annular balloon structure 682. For example, the inner radius can be about 2.5 mm to about 10 mm, more strictly about 5 mm to about 7.5 mm. The internal radius can be about 6.4 mm.
[00205] Figures 23B and 24B illustrate that the annular balloon structure 682 can have a first balloon cell 691a and a second balloon cell 691b. Figures 23B and 24B show a total of 8 balloon cells 691. Balloon cells 691a and 691b can be joined by balloon contact line 710. Similar balloon contact lines can exist between adjacent balloon cells 691 in Figures 23B and 24B. The annular balloon structure 682 may have an inner radius of balloon contact 694 and an outer radius of balloon contact 698. These radii are aligned with the innermost and outermost extent of contact between balloon cells 691a and 691b. The difference between the internal and external contact radii can be about zero. For example, balloon cells 691a and 691b may be touching only one point of tangency. The inner radius and the outer radius of balloon contact can be about 3.8 mm to about 15 mm, more strictly about 7.5 mm to about 11.5 mm. The inner radius and the outer radius of balloon contact can be about 9.5.
[00206] The radius of balloon 704 can be the radius of the circle that crosses all the geometric axes of the center of each balloon cell 691. The radius of balloon 704 can be about 5 mm to about 15 mm more strictly about 5 mm to about 13 mm. The balloon radius 704 can be about 10 mm. The carcass wall 684 can have an average carcass thickness 686 of about 7 μm to about 65 μm, more strictly about 13 μm to about 38 μm, even more strictly about 20 μm to about 30 μm. The outer radius of frame 708 can be the inner radius of frame 706 plus the thickness of the frame. The outer radius of carcass 708 can be equal to one half of the outer diameter of carcass center section 50.
The balloon radius 702 can be about 0.5 mm to about 7.6 mm, more strictly about 2 mm to about 5.8 mm, even more strictly about 3 mm to about 5 mm . The balloon radius 702 can be about 3.8 mm.
[00208] Balloon cells 691 can have about zero contact with each other and with the internal side of housing 678 (as shown in Figure 23B on housing contact line 712). The leakage area 700 between the inner wall of the housing and the balloon contacts 710 can be 12 to 22% of the total area surrounded by the cross-section of the housing, more strictly about 17%. The leakage area can be greater than 10%, more strictly greater than 15%.
[00209] Figure 24A shows an inflated annular balloon structure 682 with a housing 678. Housing 678 can fully or partially cover balloon segments 656. The balloon 650 shown in Figure 24A can have similar or identical dimensions to balloon 650 shown in Figure 23A. The housing 678 shown in Figure 24A may have a smaller external housing radius 708 than the housing 678 shown in Figure 23A. The housing 678 in Figure 24A can be placed on the balloon segments 656. The housing can compress or squeeze the balloon segments 656 so that the balloon segments 656 can be deformed and directed closer to the longitudinal geometric axis of the housing 26 Housing 678 may be in tension when balloon segments 656 are inflated
[00210] Figure 24B shows a cross-section G-G through the center of the inflated annular balloon structure 682 in Figure 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 can fluidly connect to the openings 714 in proximal cone 34 and distal cone 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 passage of central fluid 692. For example, the balloon may infuse when in the vasculature or in an air passage.
[00211] The annular balloon structure may have a second hollow axis 2000b in the central fluid passage 692. There may be a gap of flow area 693 between the second hollow axis 2000b and balloon 650. The gap of flow area 693 may be from about 2 mm to about 10 mm, more strictly from about 4 mm to about 7 mm, for example 5.5 mm. The second hollow axis 2000b is not shown in Figures 23A, 23B and 24A.
[00212] The inner radius 690 of annular balloon structure 682 shown in Figure 24B can be, for example, about 2.5 mm to about 10 mm, more strictly about 3 mm to about 5.6 mm, for example example about 4.3 mm. The area of the circle defined by the inner radius 690 can be about 0.091 square inches or about 0.59 square centimeters.
[00213] Balloon cells 691a and 691b can be joined by balloon contact line 710, for example, with a connection. The annular balloon structure 682 may have an inner radius of balloon contact 694 and an outer radius of balloon contact 698. These radii are aligned with the innermost and outermost extent of balloon contact 710 between balloon cells 691a and 691b . The inner radius of balloon contact 694 can be about 1 mm to about 20 mm, more strictly 2.5 mm to about 13 mm, more strictly about 5 mm to about 7.5 mm. The internal radius of balloon contact can be about 6.4 mm. The external radius of balloon contact 698 can be about 2 mm to about 20 mm, more strictly 5 mm to about 15 mm, more strictly about 7.6 mm to about 12.7 mm. The external radius of balloon contact can be about 10 mm. Balloon contact line 710 can have a contact length almost equal to the inner radius subtracted from the outer radius.
[00214] The balloon cell perimeter 696 is almost equal to the total length of the dotted line 696 shown in Figures 23B and 24B (the dotted line matches the wall of the balloon cell 691). Balloon cells 691 may have a 696 balloon cell perimeter of about 3 mm to about 48 mm, more strictly about 12.7 mm to about 37 mm, even more strictly about 19 mm to about 32 mm , for example about 24 mm. The length of the balloon contact line 710 can be greater than about 5% of the balloon cell perimeter 696, more strictly greater than about 10%, even more strictly greater than about 12%, for example about 16% . The balloon radius 702a can be about 0 mm to about 5 mm, more strictly about 0.5 mm to about 3 mm, even more strictly about 1 mm to about 2.5 mm, for example about 1.5 mm. The inner radius of balloon 702b can be about 0.5 mm to about 7.5 mm, more strictly about 1 mm to about 5 mm, even more strictly about 1.5 mm to about 3.8 mm , for example about 2.5 mm.
[00215] The leakage area 700 between the internal wall of the housing 678 and the balloon contact line 710 may be less than about 15% of the total area surrounded by the cross-section of the housing, more strictly less than about 10%, even more strictly less than about 5%, for example 2%. The leakage area 700 can be sealed (without fluid communication) from the central fluid passage 692. The leakage area 700 can be connected to a pressure source accessible by the physician. The leak area 700 may contain a fluid, for example, a drug. The housing wall 684 may have pores, for example, holes smaller than 0.005 mm in diameter. The casing wall 684 can perfuse from the inner casing 47 to the outer casing 49. Pressurizing the fluid in the pouring area 700 can cause the fluid in the area 700 to move from the inner casing 47 to the outer casing 49.
[00216] The arc length of the carcass contact line 712 can be about 1.3 mm to about 10 mm, more strictly about 3.3 mm to about 8.4 mm, even more strictly about 4 mm to about 7.5 mm, for example about 5.8 mm.
[00217] Figure 24b illustrates that the balloon cells 691 in the carcass contact line 712 can be concentric with the carcass 678, for example, with the carcass internal perimeter. The length of the wall of the balloon cells 691 in the carcass contact line 712 may be equal to or greater than about 5%, more strictly equal to or greater than about 10%, even more strictly equal to or greater than about 20%, the balloon cell perimeter 696 (i.e., the total length of the balloon cell wall in the side section, i.e., the section shown in Figure 24b).
[00218] The internal carcass perimeter in a plane can be almost equal to the internal carcass radius 706 multiplied by 2 multiplied by Pi. The sum of the arc lengths of all carcass contact lines 712 in a plane in the annular balloon structure 682 can be greater than 30% of the internal carcass perimeter, more strictly greater than 45%, even more strictly greater than 55% , for example, 61%.
[00219] A connection can be formed between the balloon segment 656 and the housing 678 on the housing contact line 712 with adhesive, solvent, heat or combinations thereof. Housing 678 may have adhesive 208 on the internal housing surface, for example, a thermoplastic or a thermoset.
[00220] The arc length of the carcass contact line 712 can be greater than 10% of the 696 balloon cell perimeter, more strictly greater than 15%, even more strictly greater than 20%, for example, 24%.
[00221] In some embodiments, as shown in Figures 59A to 59D, a support strip 5911 (or support strips) may extend between each of the cells 691 of the balloon structure 682. The support strip 5911 may include a film thin, such as a film that is less than 0.0127 cm (0.005 inch) thick, more strictly less than 0.0051 cm (0.002 inch) thick, even more strictly less than 0.0025 (0.001 inch) thick . In some embodiments, the support strip 5911 may include a fiber that can strengthen the thin film. The support range 5911 can be configured to act as a voltage range to transfer the load between cells 691 to the range 5911.
[00222] Different provisions of the 5911 support range are possible. For example, referring to Figures 59A to 59D, in some embodiments, the support strip 5911 can be made of a continuous piece of material that extends through the center of the balloon structure and around the outside of one or more cells 691 (as shown in Figures 59A to 59C). As shown in Figure 59A (strip 5911 is shown as extending only part of the path around balloon structure 682 for illustrative purposes only), strip 5911 can be arranged to extend along two cells along the inner circumference of the balloon structure 682, loop around the outer side of a cell 691 and then extend along two cells again along the inner circumference of the balloon structure 682. In this arrangement, each cell 691 will have at least one strip that extends around the outside after the 5911 strip is completely wrapped. In another embodiment, shown in Figure 59B, lanes 5911 can span three cells along the inner circumference of balloon structure 682, loop around the outside of a cell 691 and then extend along three more 691 cells along the inner circumference of the balloon structure 682. In this arrangement, only one cell does and one will not have a 5911 band around the outer circumference (assuming there is an even number of cells 691). In yet another embodiment, shown in Figure 59C, strip 5911 can extend around the outside of a cell 691 and then extend through the center of balloon structure 682 to wrap around the opposite cell 691 in a radius pattern. bicycle wheel icon. In other embodiments, the 5911 strip can wrap around the outside of two or more cells.
[00223] In other modalities, the 5911 strip may be non-continuous and may extend only through the center and between one or more of the 691 cells, but not around the outer side of the cells (as shown in Figure 59D and 61). For example, as shown in Figure 59D, strip 5911 can be cut at least part of the path between neighboring cells 691 so that strip 5911 does not completely wrap around the outer perimeter of cells 69. Likewise, as shown in Figure 61, two strips 5911A, B can each be cut at least part of the path between neighboring cells 691 so that stripe 5911 does not completely wrap around the outer perimeter of cells 691, but instead form parts individual range 5912a to h. It should be understood that other arrangements of bands 5911 are possible.
[00224] Referring to Figures 60A to 60B, the support strips 5911 can be narrower than the length of the balloon structure 682. In such configurations, the support strips 5 11 can extend around the entire structure of the balloon. balloon 682 more than once so as to support the entire length of balloon structure 682.
[00225] Referring to Figures 60A and 60B, if the support strips 5911 are arranged as shown in Figure 59A, then the strips 5911 can be angled longitudinally so as to spiral along the length of the balloon structure 682, allowing , thus, that the pattern continues without the band 5911 catching itself as it goes around cells 691.
[00226] In non-continuous modes, such as the design shown in Figures 59D and 61, the strip 5911 can be arranged substantially perpendicular to the longitudinal geometric axis of the balloon structure 682, and there may be multiple strips 5911 placed along the balloon structure length 682 to support the entire balloon structure 682. Additionally, referring to Figure 60C, in some embodiments, multiple strips 5911A, 5911B, 5911C, 5911D, 5911E, 591FE can be placed along the longitudinal geometric axis of the balloon. In one embodiment, a 5911AM strip is woven around balloons to cross the gap between four pairs of 691 cells. Another 5911B strip is woven directly under strip 5911 in the four opposite balloon sets (see also Figure 61). This arrangement can be repeated up to the length of the balloon. For example, as shown in Figure 60C, there can be three sets of two bands. Once attached, the individual strips 5911A, 5911B, 5911C, 591 ID, 5911E can be cut along the back side to form individual stripe pieces 5912a ah for each pair of strips (that is, in this specific example, there will be 4 pieces of range 5912 for each range 5911 and eight pieces of range 592 for each pair of ranges), as shown in Figure 61.
[00227] The support strip 5911 (or support strips 5911), due to the fact that it extends between neighboring 691 cells, can advantageously prevent 691 cells from shearing and cracking as they rub against each other. The support strip 5911 (or support strips 5911) can additionally provide increased radial hardness when the balloon structure 682 is inflated, since the presence of the strip 5911 through the center of the balloon structure 682 can provide a load-bearing function .
[00228] A support strip 5911 can be adhered to itself and / or the underlying balloon 650 in a configuration that provides sufficient flexibility of cells 691 and bands 5911 or pieces of band 5912 with respect to each other while still providing the support function of lane 5911 or lane 5911. For example, referring to Figure 61, a 5917A adhesive can be positioned to adhere to pieces of lane 5912 between neighboring cells (such as cells 691A and 691B) to while another adhesive 5917B can be positioned to adhere strip 5911 to the underlying balloon 650 and / or to the coating 5931 on balloon 650 (as further described below). Finally, a third adhesive 5917C can adhere external housing 678 to balloon 650 and / or to liner 5931 on balloon 650. Strips 5911 or strip pieces 5912 can therefore be attached to both cells 691 and one another at the point where the 691 cells are closer to each other and / or else seated against each other. The strips carry tension loads that are created by eccentric loading, better distributing the loads so that they do not create locally high flaking loads, which would destroy the balloons.
[00229] Referring to Figure 62, multiple support strips 5911 can be created from a single sheet 5913 of film, such as Mylar. For example, strips 5911A and 5911B can be cut, such as laser cut, from sheet 5913. Advantageously, using a single sheet, the adhesive for attaching strips 5911 can be placed in strips to match the placement of the adhesive with respect to cells 691 and strips 5911. Therefore, for example, strips 5921A and B of the adhesive can be placed before cutting strips 5911.
[00230] In some embodiments, an outer coating can be applied to the 650 balloon. For example, referring to Figure 63, a 650 balloon made, for example, of nylon or polyethylene terephthalate, can be coated with a 5931 balloon coating. The balloon liner 5931 may be a material of a certain elongation, such as greater than 10%, greater than 100%, greater than 600% or greater than 1,000%. For example, the 5931 balloon liner may be parylene, silicone or polytetrafluoroethylene. The balloon liner 5931 can be deposited or otherwise applied to the balloon 650 before the balloon 650 is rolled up together and / or placed inside the housing 678. After the coating is applied, the balloon 650 can be rolled up together and placed inside the housing 678, as shown in Figure 61. The coating can be applied after the balloon is woven together, however, before it is placed inside the housing. The balloon liner 5931 can advantageously help to connect the balloon 650 to the housing 678. This balloon to protect the housing interface is important due to the fact that it joins two structures of different hardness values. That is, if the balloon 650 is connected directly to the housing 678, then, during use, the housing 678 will pull or push the balloon 650. In doing so, if too much local face is placed on the connection between the two, then the thin balloon 650 tends to fail structurally at that location, causing the entire balloon 650 to burst. In contrast, if coating 5911 is instead adhered to the balloon, then coating 5931 can prevent balloon 650 from bursting. If too much load is placed on the fitting, then the 5931 liner will preferentially and locally disconnect from the 650 liner, without tearing the liner 650 instead. The liner for liner bonding may be stronger than the liner for liner bonding . The surface tension and the thickness of the parylene can be chosen to ensure that the desired shutdown occurs (that is, so that the coating provides some adhesion without tearing the balloon). For example, in some embodiments, the surface of the balloon 650 can be modified for better adhesion and / or higher surface energy. Therefore, for example, the surface of the balloon 650 can be corroded or treated with plasma (for example, corroded by plasma or treated with signal in vapor phase). In one embodiment, the surface energy of the balloon can be approximately 300 to 500 μN / cm (30 to 50 dynes / cm, such as 300, 350, 400, 450 or 500 μN / cm (30, 35, 40, 45 or 50 dynes / cm) In some embodiments, the parylene surface can also be treated or chosen to have a surface energy of approximately 0.3 to 0.5 mN (30 to 50 dynes) / cm, such as 0 , 3, 0.35, 0.4, 0.45 or 0.5 mN (30, 35, 40, 45 or 50 dynes) / cm. In some embodiments, the 5931 coating is used with the strips. In other embodiments , the coating is used without the 5911 bands.
[00231] Figure 25a shows an inflated spiral balloon 650 (as shown in Figure 20a) with a housing 678. Housing 678 can wrap, wrap or encircle balloon 650. Housing 678 can cover all or part (as shown) ) balloon 650. Figure 25b shows a longitudinal cross section HH of the annular balloon structure 682 shown in Figure 25A.
[00232] Figure 26a shows an inflated spiral balloon with a 678 housing. The balloon 650 shown in Figure 26A can have similar or identical dimensions to the balloon 650 shown in Figure 25A. The housing 678 shown in Figure 26A may have a smaller external housing radius 708 than the housing 678 shown in Figure 25A. Housing 678 in Figure 26A can be placed over balloon 650. Housing can compress or squeeze balloon 650 so that balloon 650 can be deformed or directed closer to the longitudinal axis of housing 26. Housing 678 can be in tension when the balloon 650 is inflated. Figure 17b shows a longitudinal cross-section of a spiral balloon with a housing 678. The housing contact line 712 can be oriented in the longitudinal direction. The casting area of the housing can be shaped like a spiral.
[00233] Figures 27A and 27B illustrate that the housing 678 can have a balloon 650 in the inner housing 47. The housing strut 716 may contain additional elements not included in the central housing section 38. For example, the housing strand 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 862 carcass cone reinforcements. The polymer film may have a low coefficient of friction on the outermost surface, for example, it may have a coefficient of friction less than 0.25, more strictly less than 0.15, even more strictly less than 0.1. The proximal cone 34 and the distal cone 42 can help to introduce and remove the annular balloon structure 682 through a standard vascular introducer. For example, cones 34 and 42 can protect the balloon 650 from being damaged by rubbing on the resources or vascular introducer, such as calcifications, in the body. Cones 34 and 42 can guide the annular balloon structure 682 through the introducer.
[00234] Figure 27B shows the K-K cross section of an inflated annular balloon structure 682. Figure 27D shows an approximation of a portion of Figure 27B. The balloon segments 656 can be compressed by the housing 678. The annular balloon structure 682 can have a second hollow axis 2000b, a third hollow axis 2000c and a fourth hollow axis 2000d. As shown in Figures 27B and 27D, the fourth hollow axis 2000d can engage the outer sides of axes 2000b and 2000c to make axes 2000b and 2000c approximately coaxial. The axles 2000b and 2000c can slide in the inner diameter of the axis 2000d. The axes 2000b and 2000c can be in fluid communication. A hollow shaft gap 2002 is formed between the distal end of the shaft 2000b and the proximal end of the shaft 2000c.
[00235] Figure 27C shows Figure 27B with the annular balloon structure 682 in a deflated state. Figure 27E shows an approximation of a portion of Figure 27C. Figure 27E shows that axes 2000b and 2000c move in the inner diameter of axis 2000d when the annular balloon structure 682 is deflated. The hollow shaft gap 2002 widens when the 682 annular balloon structure moves from an inflated to a deflated state. The second hollow axis 2000b, the third hollow axis 2000c and the fourth hollow axis 2000d can form an internal lumen 154a. The inner lumen 154a can extend through the center of the annular balloon structure 682. A guidewire can be inserted into the inner lumen 154a to locate the balloon during a medical procedure. The third hollow shaft 2000c and the fourth hollow shaft 2000d can be omitted and the second hollow shaft 2000b can extend to the tip of catheter 838.
[00236] The first hollow shaft 2000a may be in fluid communication with the distal hollow shaft port 54 and the balloon inflation / deflation ports 654. The addition of fluid or gas to ports 654 may cause the balloon segments 656 inflate and for the annular balloon structure 682 expand. Removing fluid or gas from ports 654 can cause balloon segments 656 to deflate and the annular balloon structure 682 to return to a pleated state, for example as shown in Figure 7C.
[00237] Figure 28A shows the K-K cross section of an inflated annular balloon structure 682. Figure 28C shows an approximation of a portion of Figure 28A. The annular balloon structure may have a second hollow shaft 2000b that slidably engages the catheter tip 838. A hollow shaft gap 2002 is formed between the distal end of shaft 2000b and the bottom pocket of catheter tip 840. A catheter tip 838 can have a catheter tip outlet 841. Fluid flow 870 (shown with a dotted line in Figure 28A) can pass through housing openings 714 in distal cone 42 or in proximal cone 34 for the passage of central fluid 692 and through the housing openings 714 in the proximal cone 34 or in the distal cone 42.
[00238] Figure 28B shows Figure 27A with the annular balloon structure 682 in a deflated state. Figure 28D shows an approximation of a portion of Figure 28B. Figure 28D shows which axis 2000b moves inside the catheter tip 838 when the annular balloon structure 682 is deflated. The hollow shaft gap 2002 increases when the annular balloon structure 682 moves from an inflated to a deflated state. The second hollow axis 2000b can form an internal lumen 154a. The internal lumen 154a can be in fluid communication with the catheter tip outlet 841.
[00239] Figure 28A shows that balloon flexing sections 670 can be in the volume surrounded by the central housing section 38 with central length 40. Figure 27B shows that the balloon flexing sections 670 can touch the housing wall 684 at tapered sections 42 and 34.
[00240] Figures 29 and 30 show that the annular balloon structure 682 may 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 can cross central fluid passage 692. Members 722 and / or support sheets 726 can be anchored to balloon segments 656 and / or to the second hollow axis 2000b. The sheets 726 can be carved or forked so that they can pass through each other. The members 722 and / or the support sheets 726 can be constructed similarly to the housing wall 684 and be substantially non-malleable. The members 722 and / or the support sheets 726 can be semi-malleable, malleable or highly malleable. The members 722 and / or the support sheets 726 can be made of an elastomer such as urethane. The members 722 and / or the support sheets 726 may comprise a fiber. The members 722 and / or the support sheets 726 may have a deformation to failure of less than about 10%. The members 722 and / or the support 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 the pressure is removed from the annular balloon structure 682, the members 722 and / or the supporting sheets 726 can help to bend the structure 682 in a way that helps folds or grooves to reform. The reforming of folds or grooves can make it easier to remove the folded balloon through the body lumens, for example, through the vasculature and through an introducer.
[00241] Figures 31A show that a valve 730 can be placed in the central fluid passage 692. Figures 31A and 31B show valve 730 in a closed position. Figure 31C shows valve 730 in an open position. Valve leaflets 734 can be anchored to balloon segments 656 or to the inner side of housing wall 684. Valve leaflets can be thin and flexible. The valve leaflets can come in contact with the outer side of the second hollow shaft 2000b when in a relaxed state.
[00242] Referring to Figure 31A, the central fluid passage 692 can be filled with a liquid or a gas. When the pressure in the liquid or gas is higher in the distal cone 42 than in the proximal cone 34, valve leaflets 734 can open (as shown in Figures 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 cone 42 and the proximal cone 34 is reduced or removed, valve leaflets 734 can close and reduce or eliminate fluid flow in the central fluid passage 692. The valve leaflets 734 can act as a one-way valve. A pressure difference in the liquid or gas between the pressure of the distal cone 42 and the proximal cone 34 can be generated by a beating heart during a medical procedure. Valve brochures 734 can serve as a temporary replacement for a heart valve (such as the aortic valve) during a medical procedure. Valve leaflets 734 can be made of a polymer film or be made in a manner similar to the housing wall 684 or be made of a highly malleable material such as, for example, an elastomer.
[00243] The exterior of the carcass wall 684 can be coated with a drug, such as paclitaxil. The drug can be delivered to the body when the 682 annular balloon structure is inflated during a medical procedure. Layer 72 or panel 196 can comprise a drug. For example, layer 72 or panel 196 may be a drug-soaked film, a drug-retaining pore film, a drug-retaining fiber matrix or combinations thereof. Layer 72 can be an outer layer 72a, an inner layer 72b or an intermediate layer, such as 72c.
[00244] Figure 32A shows a capsule 874. Capsule 874 can be an annular balloon structure 682. Figure 32B shows a cross section of capsule 874 in Figure 32A. Capsule 874 can have a capsule length 878, a capsule diameter 882 and an inner diameter of capsule 890.
[00245] Figure 32C shows an hourglass-shaped 874 capsule on the outside diameter. Figure 32D shows a cross section of capsule 874 in Figure 32C. Capsule 874 may have a capsule waist diameter 886.
[00246] Capsule length 878 divided by capsule diameter 882 can form a ratio of length to capsule width. The ratio of length to capsule width can be from about 10: 1 to about 1: 1, more strictly from about 5: 1 to about 1: 1, more strictly from about 3: 1 to 1: 1. The capsule waist diameter 886 may be less than about 90% of the capsule diameter 882, more strictly less than about 80% of the capsule diameter 882, even more strictly less than about 70% of the capsule diameter 882.
[00247] Figure 33A shows a capsule 874 with a tapered section of capsule 894 and a capsule inflation port 896. Supplying material, such as a liquid or a gas, to the capsule inflation port 896 can cause the 874 inflate. The material that is removed from the 896 capsule inflation port can cause the 874 capsule to deflate.
[00248] Figure 33B shows that a first capsule 874a and a second capsule 874b can be aligned concentric and in contact to form an annular balloon structure 682 with an hourglass shape. The first capsule 874a can be inflated or deflated in the first inflation port 896a. The second capsule 874b can be inflated or deflated in the second inflation port 896b. The internal lumens of the capsules 874a and 874b can be connected over a portion of the area where the capsules touch. Three, four, five or more 874 capsules can be joined to form an 874 annular balloon structure.
[00249] Figure 34 shows an 874 capsule in a pleated condition. Capsule 874 may have a distal cone 42 with a distal cone length 44 of about 0 mm.
[00250] The capsule wall 876 may comprise a fiber matrix, a layer 72, a panel 196 or combinations thereof. Figure 35a shows a fiber matrix with fiber 86 and adhesive 208. The fiber matrix in Figure 35a can be referred to as a unidirectional fiber matrix. Figure 35b shows a fiber matrix with reinforcement fiber 86a and reinforcement fiber 86b at an angle of about 90 degrees to each other. Figure 35C shows a fiber matrix with reinforcement fiber 86a and reinforcement fiber 86b placed at an angle of layer 738 with respect to each other. The layer angle 738 can be 45 to 70 degrees, more specifically 45, 50, 55, 60, 65 or 70 degrees. Figure 35D shows that the fiber matrix shown in Figure 35D can be combined with another unidirectional fiber matrix. Capsule 874 may have a non-pliable capsule diameter 882 when inflated.
[00251] Figure 36 illustrates that housing 678 can be partially or completely manufactured in a pressure chamber 219. Pressure chamber 219 can be in a pressure chamber housing 218. Pressure chamber housing 218 may have a casing top 220a separable from casing bottom 220b. The casing top 220a can have a casing top port 222. The casing bottom 220b can have a casing bottom port 224. The casing top port 222 can be in fluid communication with the top of the pressure chamber 219 The casing bottom port 224 may be in fluid communication with the bottom of the pressure chamber 219.
[00252] The casing top can be screwed or otherwise tightly attached to the casing bottom. The pressure chamber housing may have one or more O-rings (not shown) in O-ring seats 226.
[00253] 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 may allow pressure from the bottom casing 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. Chuck 230 may have internal dimensions of housing 678.
[00254] The mandrel 230 can be made of a certain or a low melting metal, a foam, some bending structure and an inflatable bladder. The mandrel 230 can be made of an eutectic or non-eutectic bismuth metal alloy and removed by raising the temperature to the melting point of the. Chuck 230 may be a water-soluble chuck. Mandrel 230 can be made of aluminum, glass, sugar, salt, corn syrup, hydroxypropylcellulose, amber gum, polyvinyl alcohol (PVA, PVAL or PVOH), hydroxypropylmethylcellulose, polyglycolic acid, a ceramic powder, wax, ballistic gelatin, polylactic acid, polycaprolactone or combinations thereof.
[00255] A panel 196a can be positioned on mandrel 230. Panel 196a can be single-layer or multi-layer. For example, panel 196a can be a layer of film and meltable adhesive 208. Panel 196a can be positioned with the film on the side that touches the mandrel and the adhesive on the radially outer side.
[00256] Figure 37A illustrates that a positive pressure can be applied to the top 220a of the pressure chamber (for example, through the top port of housing 222) and / or a negative pressure or differential pressure or suction or vacuum applied to the bottom 220b of the pressure chamber (for example, through the casing bottom door 224). Panel 196A can be sucked and / or pressed and / or formed on mandrel 230. The first panel 196A can be gently fitted to mandrel 230 and adhered to the mandrel on the first adhesive 208A. The first panel 196A can stretch and / or flow and / or deform. The first panel 196A may be thinner after being stretched, drained or shaped. The first adhesive 208a can be soluble in water. The first adhesive 208a can be sugar syrup. Heat can be applied to panel 196a before conforming to mandrel 230. Point sharpening of a panel 196a can be done more than once on mandrels of different sizes before panel 196a reaches the shape shown in Figure 37A.
[00257] The formation of panel 196a can also be carried out with a mechanical mold. The mechanical mold can be heated and conform closely to the shape of the mandrel 230. The mechanical mold can have a shape similar to the mandrel seat 228.
[00258] Chuck 230 and panel 196a can be mounted on an adjustment guide. Any excess portion of the first panel 196a extending from the mandrel 230 can be adjusted with a blade, with a laser, with a water jet cutter, with a mold cutting tool or combinations thereof. The adjustment guide can cover the mandrel 230 and the first panel 196a attached to the mandrel. Various panels 196a and / or layers 72 can be formed on mandrel 230 and cut. Panels 196a and / or layers 72 can be adjusted at the same time or one at a time.
[00259] Figure 37B illustrates that the mandrel may have the excess area of the first panel 196a removed in preparation to secure the second panel 196b. A second adhesive 208b can be applied to the first panel 196a around the perimeter of the contact area of the second panel 196b with the first panel 196a. Chuck 230 can be seated on chuck seat 228 with the first panel 196a on the chuck seat.
[00260] Figure 37C illustrates that after the casing top 220a is attached to the casing bottom 220b, positive and / or negative pressures can be applied to the pressure chamber as described below. The second panel 196b can be smoothly fitted or shaped by pressing on the mandrel 230 or against it and adhered to the first panel 196a on the second adhesive 208b. Adhesion can be achieved by applying heat. The first and second panels (196A and 196B) can form the inner layer 72b or the bladder 52 of the carcass wall 684. The inner layer can be airtight. The inner layer may have the ability to maintain pressure. Multiple layers can be made by repeating the method described below. The pressure chamber can be heated, for example, to decrease the viscosity of panels 196 and to decrease their module.
[00261] Figure 37D shows cross-section L-L with mandrel 230 omitted. Bladder 52 may have a first inner seam 69a, a second inner seam 69b, a first inner layer panel 74a, a second inner layer panel 74b and an inner layer 72b. Bladder 52 can be airtight.
[00262] Figure 38A shows the bladder 52 after being fitted to a mandrel 230 (the mandrel 230 is inside the bladder 52 and is not directly shown in Figure 38A). The bladder 52 can be made slightly larger in diameter and / or longer in length than the mandrel 230 to which the bladder 52 is fitted. This can allow the bladder 52 to be reassembled in the mandrel 230 with an internal seam 66 that can be sealed. Figure 38A shows a longitudinal seam 66 that extends along the length of the bladder 52. The seam 66 can be sealed with adhesive, by melting, by heating, with a solvent or combinations thereof. The sealed bladder 52 can form the inner layer 72b of a housing 678 and be airtight. The seam 66 can be an outer seam 66a or an inner seam 66b.
[00263] Figure 38B illustrates that the first bladder portion 52a can overlap in an overlapping or overlapping joint (as shown), be contiguous in a contiguity, or flange with the second bladder portion 52b at seam 66. Seam 66 can be angled, vertical or a spiral or combinations thereof.
[00264] Figure 39A shows a cross section of a bundle 270. The bundle 270 can contain about 6, 25, 100, 500 or 1,500 monofilaments. The beam 270 can have a beam height 271 and a beam width 272. The beam 270 can be approximately circular. For example, beam height 271 and beam width 272 can be about 0.025 mm (0.001 inch) to about 0.150 mm (0.006 inch), more strictly about 0.050 mm (0.020 inch) to about 0.100 mm (0.040 inch), even more strictly about 0.075 mm (0.003 inch). The beam 270 can be loosely retained together by a polymer finish (not shown).
[00265] Figure 39B shows that bundle 270 can contain a marker wire 190. The marker wire 190 can be circular as shown and radiopaque.
[00266] Figure 39C shows beam 270 after beam 270 has been spread. The beam 270 can be flattened or spread by passing the beam 270 through a closely separated set of cylinders that form a narrow clamping gap. The beam 270 can be spread by pulling the beam 270 under tension in a set of cylinders or pins. After spreading, bundle 270 may have a bundle height 271 of less than about twice the fiber height 1068, for example, almost the same fiber height 1068. The fiber height 1068 and the fiber width 1072 can be substantially unchanged after spreading. For example, fiber width 1072 and fiber height 1068 can be about 15 μm (0.0006 inch), beam width 272 can be about 210 μm (0.008 inch) and beam height 271 can be about 15 μm (0.0006 inch). Marker wire 190 is not shown in Figure 39C, but may be present after bundle 270 has been spread.
[00267] Figure 40A illustrates that a fiber matrix layer that can be made on a cylinder 232. The cylinder 232 can be configured to rotate around a cylinder axis 234. The cylinder 232 can have a diameter of about 100 mm to about 1,000 mm. The cylinder 232 can be made or coated with a non-stick material such as a fluoropolymer.
[00268] Figure 40B illustrates that a releaser 236, like a release layer, placed around the circumference of cylinder 232. The release layer can be a low-friction film or coating. The release layer can be a thin or flexible fluoropolymer sheet.
[00269] Figure 40C shows that an adhesive 208 can be placed on the release or directly on cylinder 232 (for example, if no release 236 is used). Adhesive 208 can be a thermoplastic film. Adhesive 208 may be a thermoset film. Adhesive 208 can be a thermoplastic or solvated thermoset. Adhesive 208 may have a protective film, such as paper.
[00270] Figure 40D shows the application of reinforcement fiber 86 to cylinder 232. Fiber 86 can be unwound from a spool (not shown) and wound on the upper surface of adhesive 208. Before winding, fiber 86 can be infused or coated with an adhesive 208, a solvent or both. The coating can be a thermoplastic. Fiber 86 may have been previously flattened as detailed above. 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. Fiber 86 can be placed with a gap between each successive fiber loop. The gap may be less than about 200 cm (0.008 inch), more strictly, less than about 5 cm (0.0002 inch). A heat source or solvent can be used to fix fiber 86 to adhesive 208 (i.e., stick to fiber 86 in place in adhesive 208), to melt or solvate a material in release layer 236, to melt or solvate a fiber 86 material or combinations thereof. For example, a separate resistive heater, a laser, a hot air source or an RF welder can be used. A solvent such as methyl ethyl ketone or tetrahydrofuran can be used. Fiber 86 can be wound with a pitch from 3,000 to 30 turns per 25.4 mm (1 inch). The pitch can be chosen based on the total size of fiber 86 or bundle 270 that is applied and the gap chosen between each subsequent fiber 86 or bundle 270 in cylinder 232. Applications of a single monofilament 274, which can be a yarn, can have steps from about 2,000 to about 100 turns per 25.4 mm (1 inch).
[00271] Figure 40E shows reinforcement fiber 86 on top of adhesive 208 on top of release layer 236. Figure 40E can show a cross section after the operation shown in Figure 40D is performed.
[00272] Figure 40F illustrates that the cylinder can be placed between a vacuum top sheet 238a and a vacuum bottom sheet 238b, for example, in a vacuum bag. A vacuum sealing tape 240 can surround the cylinder 232 between the upper and lower vacuum sheets 238b and 238a, respectively. Air can be removed from between the upper and lower vacuum sheets 238a and 238b and on the vacuum sealing tape, for example, by suction from a suction tube 242. Inside and / or outside the vacuum bag, the cylinder 232 can be heated, for example, to melt or cure adhesive 208. Cylinder 234 can be removed from the vacuum bag, for example, after melting or curing of the adhesive is complete.
[00273] Figure 40G shows the removal of panel 196. For example, a cut can be made substantially perpendicular to the fiber. Panel 196 can be detached from the release layer. Panel 196 can be substantially foldable and / or flexible.
[00274] Figure 40H illustrates that the fiber matrix panel 196 can be removed from cylinder 232. For example, panel 196 can be detached from release 236. Panel 196 can be positioned on cylinder 232 about 90 degrees to the anterior angle of the layer and additional reinforcement fibers 86 can be applied, as shown in Figure 39D. This can result in a panel 196 with fibers 86 running perpendicular to each other (for example, a "0 to 90" layer, named for the angle the two layers make related to each other). Panel 196 can be cut into a smaller panel. For example, panel 196 can be cut with an adjustment guide, a laser, a waterjet cutter, a die cut tool or a combination thereof.
[00275] Figure 41A shows that a panel 196 may have reinforcement fibers 86b oriented substantially parallel to the longitudinal edge of panel 332. Panel 196 may have panel width 334. Panel width 334 may be approximately equal to the circumference of the panel. frame 678 in central section 38. Panel 196 may have panel length 335. Panel length 335 may be longer than frame length 28. Panel 196 may have a rectangular section of panel 336 and one or more sawmills of panel 338a, 338b and 338c. Each panel sawmill 338a, 338b and 338c can have a portion of panel 186 that forms a portion of rod 30 or 43 and cone 34 or 44. Each sawmill 338a, 338b and 338c can have a sawing edge 339a, 339b and 339c, respectively. The angle between the edge of sawmills 339 and a line parallel to the reinforcement fibers 86b can be a panel sawing angle 340. The sawing angle of panel 340 can be about 30 °, about 20 °, about 10 ° or about 0 °. A first panel saw 338a can be substantially in line with a second panel saw 338b. One or more fibers 86b can pass from the end of the first sawmill 338a to the end of the second sawmill 338b.
[00276] Figure 41B illustrates that the longitudinal reinforcement fiber 86b can be parallel with the longitudinal edge 332. The second longitudinal reinforcement fiber 87b can be parallel with the fiber 86b. The fibers 86b and 87b can be separated by the fiber separation areas 614. The fiber separation areas 614 can separate the fibers 86b and 87b by about 2 mm, more narrowly less than about 1 mm, in a way even narrower less than about 0.25 mm. The fiber separation areas 614 can be distributed in the panel in such a way that no area 614 substantially overlaps any other area in the X and / or Y direction. The fiber separation areas 614 can be positioned in the X and Y directions in the panel 196 in a pattern sufficient to prevent any fiber from reaching the entire path through the rectangular section of panel in the X direction. Frame 678 in Figure 5 can be built, in part, with panel 196 shown in Figure 41B. Fibers 86b and 87b may have fiber lengths 88 less than about 80% of the carcass length 28, more narrowly less than about 75% in length, more narrowly less than about 70% of length, still more narrowly smaller than about 65% in length, still more narrowly less than about 60% in length.
[00277] Figure 41C shows that a panel 196 can have a rectangular section of panel 336 and one or more sawmills of panel 338a, 338b and 338c. Panel sawing 338b can be oriented in the Y direction substantially midway between panel saws 338a and 338c. Panel sawmill 338b can be oriented in the Y direction substantially closer to any panel saws 338a or 338c. The longest reinforcing fiber length 88 in panel 196 may be less than about 75% of the housing length 28, more narrowly less than about 70%.
[00278] Figure 42A shows that panel 196 may contain reinforcement fibers 85a and 85b arranged in a woven pattern. A woven pattern may have fibers 85a and 85b that alternatively pass over and under each other.
[00279] Figure 42B shows that panel 196 can contain reinforcement fibers 85 in a braided configuration.
[00280] Figure 42C shows that panel 196 may contain reinforcement fibers 85 of various lengths in random orientations, sometimes referred to as cut or cut fiber.
[00281] Figures 43A and 43B illustrate that a panel 196 can be applied to a mandrel 230 with none, one or more layers 72 in mandrel 230. Panel 196 can be joined to layers 72 through the application of adhesive or through heat or by combinations thereof. Panel 196, when folded into the shape of mandrel 230, can provide substantially complete coverage of mandrel 230 with minimal or no overlap of panel 196. The rectangular panel section 336 can cover the central frame section 38. Panel sawmills 338 can cover the proximal cone 34, distal cone 42, proximal nail 30 and distal nail 43.
[00282] A mold can be used to press panel 196 into housing 678. The mold can be heated and panel 196 can contain a thermoplastic. The mold can melt the thermoplastic and adhere the panel 196 to the housing 678. The mold can be shaped to match the shape of the chuck 230. After attaching the two sawmills 338 (one saw at each end of the chuck 230. See Figure 43A ), mandrel 230 can be rotated around its longitudinal geometric axis to advance the next set of sawmills 338 to the location under the mold. The mold can again press the two sawmills 338 in place on frame 678. Subsequent use of the mold, in this way, can substantially secure the entire panel 196 to frame 678, as shown in Figure 43B.
[00283] Figure 44 illustrates that fiber 86 can be wound over mandrel 230 or over housing 678. Fiber 86 can be continuous or batch. The mandrel can be rotated, as shown by arrow 252, around the longitudinal axis of the mandrel 250 or the longitudinal axis of the housing. The first spool 244a can be passively (for example, freely) or actively spun, as shown by arrow 254, with fiber 86 (shown) available or bundle 270. Before or during winding, fiber 86 can be infused or coated with an adhesive, a solvent or both. The coating can be a thermoplastic. A distal fiber end can be attached to housing 678 or directly to mandrel 230.
[00284] Fiber 86a can be wound with a gap between each successive fiber loop. The gap may be less than about 200 μm (0.008 inch), more narrowly less than about 5 μm (0.0002 inch).
[00285] Fiber 86 can be wound with a pitch of about 3,000 to about 30 turns per 25.4 mm (1 inch). The step can be chosen based on the total size of fiber 86 or bundle 270 which is applied to the part of the first spool 244a and the gap chosen between each subsequent fiber 86 or bundle 270 in the part. Applications of a single 274 monofilament, which can be a yarn, can have steps from about 2,000 to about 100 turns per 25.4 mm (1 inch).
[00286] A tool arm 246 can be attached to a rotating tool wheel 248. Tool arm 246 can rotate and translate, as shown by arrows 256 and 258, to position tool wheel 248 normal to frame 678 or in contact with it. A second tool wheel 248 '(attached to the tool arm 246') may have a range of motion sufficient to apply normal pressure to the surface of a carcass cone section.
[00287] Tool wheel 248 can press fiber 86 or bundle 270 against frame 678 and spread monofilaments 274. Tool wheel 248 can help adhere bundle 270 to the frame, for example, by applying pressure and following close up the carcass surface. The tool wheel 248 can be heated to soften or melt the material on the surface of the housing 678. Another heat source or a solvent can be used to adhere the fiber in place, to melt or solvate a material in the housing, to melt or solvate a material in the fiber or combinations thereof. A separate resistive heater, a laser, a UV light source, an infrared light source, a hot air source or an RF welder can be used with or without the 248 tool wheel to secure the fiber. A solvent such as methyl ethyl ketone or tetrahydrofuran or alcohol or combinations thereof can promote fiber adhesion 86 and can be used with or without tool wheel 248. Tool wheel 248 can be made of or coated with a non-woven material. adherent. Tool wheel 248 may not rotate. The tool wheel 248 may comprise a hard surface, for example, carbide.
[00288] A second spool 244b can arrange the marker wire 190 during a winding operation. The second spool 244b may also have a reinforcement fiber 85 (not shown). Marker wire 190 (or reinforcement fiber 85) can be applied simultaneously with fiber 86 and / or bundle 270 in the housing. Marker yarn 190 can interleave with reinforcement fiber 86 to form a single layer of fiber in housing 678. Marker yarn 190 may be deposited on top below another existing fiber layer.
[00289] The resulting layer deposited in Figure 44 can have a layer 216 thickness of about 1 μm (0.00004 inch) to about 50 μm (0.002 inch), more narrowly about 8 μm (0, 0003 inch) to about 25 μm (0.001 inch).
[00290] The techniques described in Figures 36, 37A, 37B and 37C can be used to apply additional panels 196 or layers 72 to frame 678. For example, two panels 196 can be applied to form an outer layer 72a on frame 678, as shown in Figure 45A.
[00291] Figure 45B shows that a panel 196e can be applied to the proximal end of the balloon. Similarly, a panel 196f can be applied to the distal end of the balloon. In some embodiments, the panels 196, e, f can be applied after a layer or panel of the fiber has been placed in the housing. In other embodiments, panels I96e, f can be applied before a fiber layer or panel has been placed on the housing. For example, panels 196e and 196f can be applied to bladder 52, as shown in Figures 37 and 38. Panels 196e and 196f could be like those shown in Figures 46A and 46B.
[00292] Figure 46A shows a panel 196 with panel cutout 842 and panel cutout 846. Panel cutout 842 can be aligned on a housing 678 to form an opening 714. Panel cutout 846 can be placed on a housing 678 to form a carcass reinforcement shoulder 866.
[00293] Figure 46B shows a panel 196 with a panel cut 850. The panel cut 850 can allow the panel to form on the housing 678.
[00294] In some embodiments, radiopaque dye or a radiopaque marker (such as a foil) can be used to mark panel 196 before or after it is formed on housing 678. The radiopaque dye and / or radiopaque marker can be used as markers during implantation and / or to mark the visual identity.
[00295] Figure 47 illustrates that a wash tube 264 can be inserted into a chuck disposal port 262. A solvent or solvent fluid can be delivered through the wash tube and to the disposal port 262. The chuck can be removed by delivering a fluid solvent such as water, alcohol or a ketone. The solvent can be applied during the consolidation process in such a way that the solvent melts or partially softens the mandrel and concurrently pressurizes the bladder. Chuck 230 can be removed by raising the chuck to a melting temperature for the chuck. Chuck 230 can be removed by deflating the chuck or by bending an internal frame.
[00296] Figure 48A illustrates that housing 678 can be placed in a housing mold 622 containing a housing pocket 624. Housing mold 622 can be porous such that substantial amounts of gas can be extracted from the housing pocket 624 through the housing mold wall 622 and into the surrounding atmosphere. The housing 678 can have a tube (not shown) placed in its internal volume that can extend at any end of the housing 622. The tube can be thin and very flexible. The tube can be a silicon rubber.
[00297] A coating can be sprayed on mold 622 which attaches to housing 678 during curing and forms an outer layer 72a on housing 678.
[00298] Figure 48B illustrates that the housing mold 622 can be closed around the housing 678. Pressure can be applied through the second housing fluid port such that the housing expands to make contact with the side of the housing. inside the housing pocket 624. Alternatively, the tube (not shown) extending out of either end of the housing can be pressurized to force the housing into contact with pocket 624.
[00299] Figure 48C shows the Pressure P within the carcass volume that presses the carcass wall 684 outward. Mold 622 can be placed in an oven and heated. The 622 mold may have built-in heaters. Housing mold 622 can be placed under vacuum or placed in a vacuum chamber during heating. The carcass mold 622 can have a texture, such as a texture created by abrasion or sandblasting or ball blasting of the carcass mold 622. The texture can impart a texture to the outer layer 72b of the carcass.
[00300] Heating the housing under pressure can cause one or more layers 72 to melt and / or melt and / or bond with the adjacent layers 72. Melting under pressure can remove the gaps in the housing wall. The inner and outer films may not melt. Heating the housing under pressure can cause the walls of the housing 678 to fuse or laminate in a continuous structure. The outer shell layer 72a can be substantially softened by this process. The outer shell layer 72a may be permeable or perforated in such a way that gas or other material trapped in the shell wall 684 during manufacture can escape when the shell is heated under pressure.
[00301] The outer radius of frame 708 can be very accurate and repeatable. For example, at a given pressure, the outer radius 708 of a group of carcasses 678 can all be about 2% (+/- 1%) of each other. For example, if the nominal dimension of the outer radius 708 of the housing is about 12 mm at about 414 kPa (60 psi), all housings can have an external 708 radius of about 11.88 mm at about 12.12 mm.
[00302] A 678 frame can be attached to a pleating tool with two, three, four, five or more removable plating blocks. Heating the pleating blocks to around 80C and then pressing them against the housing 678 for about 1 minute causes the housing to become pleated or fluted. Commercial pleating machines such as Interface Associates folding machinery (Laguna Niguel, CA) can also be used. A small amount of wax can be used to retain the pleated and folded carcass to its desired shape.
[00303] As shown in Figures 49A and 49B, a balloon 650 can be placed in an insertion tool 854. Before being placed in insertion tool 854, the balloon 650 can be coated in an adhesive 208 or a solvent. The insertion tool 854 can comprise a tube that will not adhere to most adhesives, for example, the tube can comprise a fluoropolymer.
[00304] Figure 49C shows that the openings 714 can be cut in the housing 678, for example, with a laser 858. A housing 678 can be manufactured with openings 714 already in place. Figure 49D shows that the insertion tool 854 can be inserted through opening 714 in the inner housing 47. The insertion tool 854 can be inserted through the inner volume of the proximal housing rod 30 or the distal housing rod 43 or any other hole in housing 678. A cut in housing 678 can be made to allow insertion tool 854 in inner housing 47. Figure 49E shows that insertion tool 854 can be removed by leaving balloon 650 in inner housing 47. Figure 49F shows that the balloon 650 can be inflated inside the housing 678. The adhesive 208 or a solvent or the application of heat can connect the balloon 650 to the inner wall of the housing 678 forming the annular balloon structure 682.
[00305] Figure 50 illustrates a balloon catheter. Inflation fluid can be delivered via disposable syringe 472 through catheter Y fitting 634. Inflation fluid can flow between the inner wall of the first hollow shaft 2000a and the outer wall of the second hollow shaft 2000b. The inflation fluid can flow to the balloon 650 to inflate the annular balloon structure 682. A guide wire can be inserted into the guide wire port 632 and through the interior of the second hollow shaft 2000b.
[00306] Figure 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 within diameter 436 and a tube within the cross sectional area of diameter 434. The annular balloon structure 682 can be inserted into tube 428 without damaging the balloon structure annular 682. Tube 428 can be, for example, an introducer or a balloon protection sleeve used to store the balloon.
The compression ratio of the 682 annular balloon structure 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 of twice the outer casing radius 708 of the substantially inflated annular balloon structure 682 to the inner tube diameter 436. For example, an annular balloon structure 682 with outer casing radius 708 equal to about 12.2 mm can be inserted into a tube 428 with an inner diameter of tube 436 of about 4.8 mm, more narrowly about 4 mm, even more narrowly about 3.6 mm.
[00308] The annular balloon structure 682 may have a packing density equal to or greater than about 40%, more narrowly greater than or equal to about 55%, even 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 cross-sectional area of the inner diameter of tube 434.
[00309] The packing density and compression ratios for the 682 annular balloon structure may remain substantially constant and the strength of the 682 annular balloon structure wall may remain substantially constant with repeated insertions or withdrawals of tube 428 and / or the inflations and deflations of the 682 annular balloon structure, for example, 10 or 20 or 40 insertions and withdrawals or inflations and deflations.
[00310] The annular balloon structure 682 may have an unsupported burst pressure. Unsupported burst pressure is the pressure at which the 682 annular balloon structure breaks when inflated in open air without any external restrictions on the walls at about 101.3 kPa (1 atm) of external pressure and about 20 ° C temperature. The unsupported burst pressure can be from about 202.6 kPa (2 atm) to about 2,026.5 kPa (20 atm), more closely from about 303.9 kPa (3 atm) to about 1,215 , 9 kPa (12 atm), even more narrowly from about 405.3 kPa (4 atm) to about 810.6 kPa (8 atm), for example, 506.6 kPa (5 atm), 607, 9 kPa (6 atm) or 709.2 kPa (7 atm).
[00311] The 682 annular balloon structure can be non-malleable or non-elastic. For example, the annular balloon structure 682 may have a failure deformation of less than about 0.30, more narrowly less than about 0.20, still more narrowly less than about 0, 10, even more narrowly less than about 0.05.
[00312] Failure deformation of the annular balloon structure 682 is the difference between the external radius of carcass 708 when the balloon is inflated to 100% of burst pressure and the external radius of carcass 708 when the balloon is inflated to 5% the burst pressure (ie, to expand from a deflated state without stretching the wall material) divided by the outer radius of carcass 708 when the balloon is inflated to 100% of the burst pressure.
[00313] The 682 annular balloon structure may have a malleability of less than about 2% per atmosphere, more narrowly less than about 1% per atmosphere, even more narrowly less than about 0, 7% per atmosphere, even more narrowly less than about 0.4% per atmosphere.
[00314] The annular balloon structure 682 can be inflated to a pressure A and a pressure B. Pressure B can be a pressure higher than pressure A. Pressures B and A can be positive pressures. Pressures B and A can be greater than 101.3 kPa (1 atm). The delta pressure can be the pressure B minus the pressure A. The delta radius can be the external radius of the carcass 708 when the annular balloon structure 682 is inflated to the pressure B minus the external radius of the carcass 708 when the annular balloon structure 682 is inflated to pressure A. The malleability can be the delta radius divided by the outer radius of carcass 708 when the annular balloon structure 682 is inflated to pressure B divided by the delta pressure.
[00315] A 678 frame can be constructed with fiber patterns 85 similar to those shown in Figure 4. For example, fiber reinforcement member 85c can be omitted and fiber 85a can be placed at +20 degrees and fiber 85b it can be placed at -20 degrees from the carcass longitudinal axis. The first reinforcement fibers 85A can form a layer angle 738 with respect to the second reinforcement fibers 85b. The layer angle 738 can be about 40 degrees. As the housing 678 is tensioned by the balloon 650, the angle between the fibers will gradually increase until the layer angle 738 is about 70 degrees. This is the 738 angle at which the fibers balance the longitudinal and rim loads on the carcass. The fibers can change their angle to each other by deforming the adhesive. Housing 678 can expand rapidly to a first diameter where the layer angle 738 is, for example, about 40 degrees and then slowly expands at diameter 50 as the internal pressure in housing 678 of the balloon 650 is increased. By choosing the initial diameter 50 and the layer angle 738, a housing 678 can be designed to allow a variety of diameters 50 to be achieved.
[00316] Figure 52 shows a cross section of the heart 562. Heart 562 has an aorta 568, a left ventricle 570 and an aortic valve 564.
[00317] Figure 53 is a graph that shows how percentage stenosis creates acceptable, difficult and critical flow conditions in both a patient's resting and stress conditions. The acceptability of a stenosis condition would additionally vary as a function of the time spent on each condition.
[00318] Figures 54A and 54B illustrate that a guide wire 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 guide wire through the aorta 568. The 682 annular balloon structure can be in a deflated or pleated state when first placed in the aortic valve 564. The 682 annular balloon structure can be positioned to align along the longitudinal geometric axis of the balloon with valve leaflets aortic valve 566. The annular balloon structure 682 can also be rotated around the longitudinal geometric axis of the balloon to align with the aortic valve 564, for example, when the leaflets 566 attached to a bicuspid aortic valve with a flange are separated, a fin, blade, other cutting element described in this document or combinations thereof. Fluid flow 870 can leave the left ventricle 570 through aortic valve leaflets 566 and into the aorta 568. Fluid flow 870 can comprise blood flow.
[00319] Figure 54C shows the 682 annular balloon structure in an inflated configuration. The annular balloon structure 682 can be non-malleable and opens 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 annular space 582 of the aortic valve 564. The annular balloon structure 682 can radially expand the annular space of the aortic valve 582.
[00320] Fluid flow 870 can pass through the carcass openings 714 in the distal cone 42, for the passage of central fluid 692 and through the carcass openings 714 in the proximal cone 34, thus allowing blood to be perfused while the structure of balloon 692 is inflated. The central fluid passage 692 could have a cross-sectional area of 0.3 to 1.2 square centimeters, more narrowly of 0.5 to 0.8 square centimeters.
[00321] When the 682 annular balloon structure is inflated, there may be a pressure differential between the left ventricle 570 and the aorta 568. For example, the pressure differential may be about 0.66 kPa (5 mmHg) at about 6.66 kPa (50 mmHg), more closely from about 1.33 kPa (10 mmHg) to about 5.33 kPa (40 mmHg), even more closely, from about 1.33 kPa (10 mmHg) at about 3.33 kPa (25 mmHg).
[00322] Perfusion may allow a physician to leave the balloon structure inflated in aortic valve 564 for longer than would be allowed with a balloon that does not infuse while still preventing significant damage to the patient or the patient's hemodynamics. Increasing the time of inflation can allow a more careful and accurate remodeling of the vasculature, as is done during a valvuloplasty or a PCTA procedure.
[00323] One or more segments 656 of balloon 650 may employ a malleable material. Raising and lowering the pressure on these pliable segments 656 can cause the volume of the segment to change. A change in segment volume 656 may cause the central fluid passage area 692 to change. A physician can initially place the annular balloon structure 682 and then adjust the pressure in the balloon 650 or balloon segments 656 to fit the flow area gap 693. The flexible balloon segment 656 can be an additional confined balloon by housing 678 with an inflation lumen separate from that used to inflate the 650 balloon
[00324] The physician can inflate the annular balloon structure 682 until structure 682 makes contact with aortic valve 564 or valve leaflets 566 or other vascular structures. This contact with the vasculature can be confirmed through the use of small flashes of radiopaque contrast. Once the annular balloon structure 682 is in contact with the vasculature, increases in pressure delivered to the annular balloon structure 682 can be used to make changes in the center section outside diameter 50 of the annular balloon structure and then change the shape of the patient's vasculature. The change in the shape of the vasculature can be monitored by ultrasound, fluoroscope or other methods known in the art. Changing the shape of the patient's vasculature using this method can take more than 10 seconds, more narrowly more than 30 seconds, even more narrowly more than 60 seconds while it does not adversely affect the patient's health.
[00325] The 562 heart may beat at its normal rhythm during the procedure. The 562 heart may be forced to beat at a high rate during the procedure.
[00326] Figure 54D illustrates that the annular balloon structure 682 can be deflated, contracted and removed from the 566 aortic valve leaflets.
[00327] Figure 54FE shows the 566 aortic valve leaflets with a larger opening than before the procedure.
[00328] Instead of using a guidewire, an IVUS or OCT system can be inserted into the inner lumen 154a. These systems can allow visualization of the aortic valve 564, for example, the positioning of the valve leaflets 566 at any point during the procedure detailed in Figures 54A to 54F.
[00329] The method described in Figures 54 above can be performed on an aortic, mitral, pulmonary, tricuspid or vascular valve. This method can be described as balloon valvuloplasty or aortic balloon valvuloplasty. This procedure can be described as pre-dilation when used to prepare the aortic valve for implantation of a prosthetic valve. This procedure can also be used after a prosthetic valve is in place to better seat the valve on the patient's anatomy. In this case, it is often referred to as "post-dilation".
[00330] Referring now to Figures 55A to 55F, the annular balloon structure 682 can be used to arrange a prosthetic valve, for example, on aortic valve 564 near coronary ostia 583. A guide wire 572 can, first, be introduced through aorta 568 into left ventricle 570, as shown in Figure 55A. Then, as shown in Figure 55B, a prosthetic carrying balloon catheter 626 and deflated annular balloon structure 682 can be introduced through guide wire 572 into aortic valve 564. In Figure 55C, annular balloon structure 682 is inflated to expand the prosthetic heart valve 626 to the aortic valve 564. Although the annular balloon structure 682 is inflated, the flow of fluid (eg blood) 870 can pass through the carcass openings 714 in the distal cone 42, for the passage of central fluid 692 and through carcass openings 714 in the proximal cone 34. In Figure 55D, the annular balloon structure 682 is deflated and separated from valve prosthesis 626, leaving valve prosthesis 626 implanted in aortic valve 564. Figures 55E and 55F show the closure (55E) and opening (55F) of the prosthetic valve immediately after the annular balloon structure 682 is removed.
[00331] Figure 56A illustrates that the annular balloon structure 682 can be positioned on a guide wire 572 or stylus in a body lumen 574 that has a constriction 576 inside the lumen wall 578. A stylus can be harder than than a guidewire.
[00332] Figure 56B illustrates that the annular balloon structure 682 can be inflated and expanded. The annular balloon structure 682 can reshape the body lumen 574, pushing the constriction 576 radially out of the longitudinal geometric axis of the carcass 26. The annular balloon structure 682 can have a stent in the constriction 576. Although the annular balloon structure 682 is inflated, the flow of fluid (e.g., blood) 870 can pass through the carcass openings 714 in the proximal cone 34, for the passage of central fluid 692 and through carcass openings 714 in the distal cone 42.
[00333] Figure 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, by restoring flow blood after a treated atherosclerotic length.
[00334] The body lumen 574 can be a vessel or an air passage. Constriction 576 can be an atherosclerotic plaque or a local narrowing of the body lumen 574
[00335] The annular balloon structure 682 can be implanted in the body in a semi-permanent or permanent way.
[00336] 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 (for example, to open or expand a vessel), brachytherapy, to intentionally obstruct a vessel or combinations thereof. The 682 annular balloon structure can be used to deliver one or more stents and / or valves and / or plunger filters to the coronary blood vessels (for example, arteries or veins), the carpal artery, peripheral blood vessels, the GI tract, the bile ducts, urinary tract, gynecological tract and combinations thereof.
[00337] The reinforcement fibers 85, 86 and 87 can be identical or different from each other.
[00338] Referring to Figures 64A and 64B, in some embodiments, an external semi-flexible or malleable balloon 6401 can be placed around the housing 678. For example, the external balloon 6401 can be made of urethane or latex or silicone.
[00339] In the modalities in which an external balloon 6401 is placed around it, a separate inflation lumen 5941 can be used to inflate the external balloon 6401. Using a semi-flexible or malleable external balloon 6401 on the outside of the device it can advantageously provide a wider range of outside diameters for the structure. Such a semi-flexible or malleable 6401 external balloon around the device can be used, for example, where the required dimensional accuracy is lower, but the variation in anatomical lumen size is greater. For example, a 6401 semi-malleable or malleable external balloon may be useful for attaching a laceration to the aortic wall or for aortic dissection or transection.
[00340] In use, a structure that has the 6401 outer balloon can be inserted into a blood vessel. The inner balloon 650 can be inflated. After inflation, the outer housing 678 will not fully contact or conform to the outer wall. The outer balloon 6401 can then be inflated through the inflation lumen 5941 until it conforms or rests against the inner walls of the vessel. If the entire structure needs to be relocated, the outer balloon 6401 can be deflated while the inner balloon 650 can remain inflated, the structure can be relocated and the outer balloon 6401 can be inflated again.
[00341] The structures described in this document can advantageously have an internal perfusion area to catheter shaft outside diameter ratio greater than 1. Thus, the internal perfusion area can advantageously collapse to almost zero during the insertion and then expand to more than the outside diameter of the catheter after inflation. For example, as shown in Figures 27C and 28B, the perfusion area may be close to zero when the structure is folded, while, as shown in Figures 27B and 28A, the internal perfusion area may be larger than the axis area. catheter. Having a ratio greater than 1 is important to create a large internal flow area for a given catheter size. Such a large internal flow area is significant, for example, when replacing the aortic valve due to the fact that the aortic valve uses so much of a viscous medium (blood, which is 1,000 times denser than the air that passes through the dilation of the air passage) and a very large hole (average of 24 mm, compared to 4 or 5 mm in the coronary arteries).
[00342] Any elements described in this document as singular can be pluralized (that is, anything described as "one (01)" can be more than one) and the 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 intended to be limiting. The configurations, elements or complete assemblies and methods and their elements described above for carrying out the invention and variations of aspects of the invention can be combined and modified with each other in any combination. INCORPORATION BY REFERENCE
[00343] All publications and patent applications mentioned in this specification are incorporated into this document as a reference, in the same sense, as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference. CONCLUSION
[00344] The description can be considered to be related to the following items:
[00345] 1. An apparatus to perform a medical procedure, which comprises:
A balloon structure having a first tapered portion and a second tapered portion spaced longitudinally from the first tapered portion; and
[00347] a housing that includes a first neck section to cover, at least partially, the first tapered portion, a second neck section spaced from the first neck section to cover at least partially the second tapered portion and a plurality of circumferentially spaced ribs connecting the first neck section to the second neck section.
[00348] 2. The apparatus of item 1, in which at least the first neck section of the housing comprises an opening.
[00349] 3. The apparatus of item 3, in which the first neck section and the second neck section each comprise a plurality of openings.
[00350] 4. The apparatus of item 2 or item 3, in which the opening or openings have a shape selected from the group consisting of circular, elliptical, rectangular, teardrop, hexagonal or combinations thereof.
[00351] 5. The device in item 1, in which:
[00352] the first neck section comprises a plurality of shoulders; and
[00353] the second neck section comprises a plurality of strips, each of which is adapted to interconnect with the first neck section to form the circumferentially spaced reinforcements.
[00354] 6. The apparatus of item 5, in which each strip is connected with one of the shoulders.
[00355] 7. The apparatus of item 5, in which each strip includes an end adapted to position in a notch between the adjacent shoulders of the first neck section.
[00356] 8. The apparatus of item 5, in which each strip includes a curved end.
[00357] 9. The apparatus of any of the previous items, in which one of the first neck section, the second neck section or the reinforcements comprises a plurality of relief slits.
[00358] 10. The apparatus of any of the previous items, in which one of the balloon structure or the housing comprises fibers.
[00359] 11. The device of any of the previous items, additionally includes a layer to cover the housing.
[00360] 12. The apparatus of item 11, in which the layer comprises fibers.
[00361] 13. The apparatus of any of the previous items, in which both the balloon structure and the housing comprise fibers.
[00362] 14. The apparatus of any of the previous items, in which the balloon structure comprises a plurality of cells that form a ring with a central path.
[00363] 15. The apparatus of item 14, which additionally includes at least one strip to connect at least one cell of the balloon structure to at least another cell of the balloon structure.
[00364] 16. The apparatus of item 15, in which the strip comprises a film.
[00365] 17. The apparatus of item 15 or item 16, in which the band comprises a fiber.
[00366] 18. The apparatus of item 15, in which the band is wrapped around a plurality of cells of the balloon structure.
[00367] 19. The apparatus of item 15, in which the strip is wrapped around the plurality of cells of the balloon structure sequentially in a circumferential direction.
[00368] 20. The apparatus of item 15, in which the band is wrapped around an external side of at least two cells of the balloon structure.
[00369] 21. The apparatus of item 15, which additionally includes a plurality of bands, each band being for connecting at least one cell to at least another cell.
[00370] 22. The device of any of items 15 to 21, which additionally includes an adhesive to connect the band or bands to the cells.
[00371] 23. The device in item 15, in which the lane is located at least partially on the route.
[00372] 24. The apparatus of item 1, in which the balloon structure is pleated and comprises a plurality of wings and a single reinforcement is associated with each wing of the balloon structure.
[00373] 25. The apparatus of item 1, in which the balloon structure is pleated and comprises a plurality of wings and at least two reinforcements are associated with each wing of the balloon structure.
[00374] 26. The device of any of the previous items, which additionally includes an adhesive to connect the housing to the balloon structure.
[00375] 27. The apparatus of any of the previous items, in which the reinforcements have a variable width in the longitudinal direction.
[00376] 28. The apparatus of any of the previous items, in which the spacing of one reinforcement from another in a circumferential direction is greater than the dimension of the reinforcement in the circumferential direction.
[00377] 29. The apparatus of any of the previous items, which additionally includes a mandrel to support the balloon structure.
[00378] 30. An apparatus for use in the formation of a medical balloon, comprising:
[00379] a mandrel;
[00380] a bladder in the mandrel, the bladder having a first tapered portion and a second tapered portion; and
[00381] a carcass on the bladder, the carcass including a first neck section to cover, at least partially, the first tapered portion and a second neck section spaced longitudinally from the first neck section to cover, at least partially, the second tapered portion and a plurality of circumferentially spaced reinforcements that connect the first neck section to the second neck section.
[00382] 31. The apparatus of item 30, in which the mandrel comprises a first generally tapered portion and a second generally tapered portion and in which the first neck section is adapted to wrap substantially around the first generally tapered portion and the second neck section is adapted to wrap substantially around the second generally tapered portion.
[00383] 32. The apparatus of item 29 or item 30, in which the mandrel comprises a barrel portion and the reinforcements are adapted to extend only along the barrel portion of the mandrel.
[00384] 33. The apparatus of any of the preceding items, wherein the first and second tapered portions of the balloon structure, each comprise a plurality of openings to allow fluid to flow through the balloon structure.
[00385] 34. An apparatus for performing a medical procedure, comprising:
[00386] a balloon structure comprising at least one layer of fibers and a plurality of circumferentially spaced longitudinal hardening strips to reinforce the balloon structure.
[00387] 35. The apparatus of item 34, in which the fibers comprise longitudinal fibers, fibers in a loop or both.
[00388] 36. The apparatus of item 34 or item 35, in which the longitudinal hardening strips form part of a housing that includes a plurality of openings to allow fluid to enter an interior housing of the housing.
[00389] 37. The apparatus of any of items 34 to 36, which additionally includes a balloon in the interior compartment.
[00390] 38. The apparatus of any of items 34 to 37, in which the balloon comprises a plurality of cells that form a ring with a path in the center.
[00391] 39. The apparatus of any of items 34 to 38, wherein the balloon structure is pleated and comprises a plurality of wings and at least one longitudinal hardening strip is associated with each wing of the balloon structure.
[00392] 40. The apparatus of any of items 34 to 39, in which the longitudinal hardening strips are wider than the fibers.
[00393] 41. The apparatus of any of items 34 to 40, in which the longitudinal hardening strips have a variable width in the longitudinal direction.
[00394] 42. The apparatus of any of items 34 to 41, in which the fiber layer overlaps the longitudinal hardening strips.
[00395] 43. An apparatus for performing a medical procedure, which comprises:
A balloon structure comprising a plurality of cells; and
[00397] a strip that extends between the plurality of cells of the balloon structure and connects it.
[00398] 44. The device of item 43, in which the cells are connected by the band are adjacent to each other.
[00399] 45. The apparatus of item 43, in which the cells are opposite each other.
[00400] 46. The apparatus of any of items 43 to 45, in which the strip extends along an external side of the cell (s).
[00401] 47. The apparatus of item 43, which additionally includes a plurality of bands to interconnect the plurality of cells of the balloon structure.
[00402] 48. The apparatus of any of items 43 to 47, which additionally includes an adhesive to attach the band or bands to the balloon structure.
[00403] 49. The apparatus of any of items 43 to 48, which additionally includes a housing adapted to receive the balloon structure.
[00404] 50. The apparatus of item 49, in which the housing includes a first neck section and a second neck section longitudinally spaced from the first neck section and which additionally includes a plurality of circumferentially spaced reinforcements connecting the first section neck to the second neck section.
[00405] 51. The apparatus of any of items 43 to 50, in which the balloon structure comprises a plurality of distinct balloons, each of which forms one of the cells and has an entrance and an exit.
[00406] 52. The apparatus of any of items 43 to 51, in which the balloon cells form a ring that has a central path.
[00407] 53. The apparatus of item 52, in which the strip is at least partially positioned in the central path.
[00408] 54. The apparatus of item 52, in which the strip extends between the first and second balloon cells, up to the central path, between the second and third balloon cells and up to the central path again.
[00409] 55. An apparatus to perform a medical procedure, which comprises:
[00410] a balloon structure comprising at least two adjacent cells; and
[00411] a strip positioned between at least two adjacent cells, said strip connecting at least two adjacent cells to each other.
[00412] 56. An apparatus to perform a medical procedure, which comprises:
[00413] a balloon structure comprising a plurality of cells that generally extend parallel to each other in a longitudinal direction; and
[00414] a strip that interconnects the plurality of cells.
[00415] 57. The apparatus of item 56, in which the plurality of cells of the balloon structure is arranged in a ring that forms a central path and in which the band is positioned at least partially in the central path.
[00416] 58. The apparatus of any of the previous items, in which the balloon structure includes a single inflation lumen and a single deflation lumen.
[00417] 59. The apparatus of any of the previous items, in which the balloon or the balloon structure comprises parylene.
[00418] 60. A method of reinforcing a balloon structure, comprising:
[00419] providing a first tapered portion of the balloon structure with a first neck reinforcement section;
[00420] providing a second tapered portion of the balloon structure with a second neck reinforcement section; and
[00421] providing the balloon structure which has a plurality of reinforcement structures circumferentially spaced between the first and the second neck reinforcement sections.
[00422] 61. The method of item 60, in which each stage of supply comprises, adhesively attaching the first and second neck reinforcement sections and the reinforcement structures to an underlying material of the balloon structure.
[00423] 62. The method of item 60, wherein the balloon structure comprises a mandrel and which additionally includes the step of removing the mandrel after the supply step to leave a housing that has an interior compartment.
[00424] 63. The method of item 62, which additionally includes the step of inserting a balloon in the interior compartment.
[00425] 64. The method of item 63, in which the balloon comprises a plurality of cells, each of which extends in a longitudinal direction and which additionally includes the step of connecting the cells together.
[00426] 65. The method of item 62, in which the connection step comprises connecting a first cell to a second cell with a strip.
[00427] 66. The method of item 64 or item 65, wherein the connection step comprises applying an adhesive between a first cell and a second cell.
[00428] 67. A method of forming a device to perform a medical procedure, which comprises:
[00429] providing an inflatable balloon structure comprising a plurality of cells, each of which has a longitudinal geometric axis; and
[00430] connecting a first cell of the plurality of cells of the balloon structure to a second cell of the plurality of cells with the use of a strip.
[00431] 68. The method of item 67, which additionally includes the step of applying an adhesive between the first cell and the second cell.
[00432] 69. The method of item 67 or item 68, which additionally includes the step of applying an adhesive to the strip before the connection step.
[00433] 70. The method of item 67, which additionally includes providing a carcass over the first and second cells.
[00434] 71. The method of item 67, in which the second cell is circumferentially arranged in relation to the first cell and the method includes the step of extending the strip along the first and second cells in a circumferential direction.
[00435] 72. A method of forming an apparatus to perform a medical procedure, comprising:
[00436] providing an inflatable balloon structure comprising at least two adjacent cells; and
[00437] connect the at least two adjacent cells together using a strip positioned at least partially between the adjacent cells.
[00438] 73. The method of item 72, which additionally includes applying an adhesive between adjacent cells.
[00439] 74. The method of item 73, which additionally includes providing a reinforcement on the cells.
[00440] 75. A method of forming a balloon structure with preferential folding capacity, comprising:
[00441] providing a balloon structure with a plurality of wings in a pleated configuration and a plurality of circumferentially spaced longitudinal hardening strips, at least one longitudinal hardening strip corresponding to each of the plurality of wings in the pleated configuration.
[00442] 76. The method of item 75, which additionally includes the step of providing the balloon structure with a plurality of longitudinally extending fibers and in which each longitudinal hardening strip is wider than each of the fibers.
[00443] 77. The method of item 75 or item 76, which additionally includes the step of providing the balloon structure with a layer of fibers on the longitudinal hardening strips.
[00444] 78. The method of any of items 75 to 77, which further includes the step of providing the balloon structure with a plurality of openings to allow fluid to flow through the balloon structure.

权利要求:
Claims (14)
[0001]
1. Apparatus of inflatable structure for use as an inflatable medical device, characterized by the fact that the apparatus has a housing (678) that has a longitudinal geometric axis of the housing, a central section, a first neck section (34) and a second neck section (42), strips (5703) that extend between the first neck section (34) and the second neck section (42) to provide additional longitudinal hardness to the apparatus, in which the apparatus has a first opening ( 714) in the first neck section (5701) and / or a second opening (714) in the second neck section (5702), in which the housing (678) includes a reinforcement (5700) having a proximal tapered portion (5701) that it covers the first neck section (34) and a distal tapered portion (5702) which covers the second neck section (42) and comprising the strips (5703).
[0002]
2. Apparatus according to claim 1, characterized by the fact that the strips (5703) also assist in refolding the housing (678).
[0003]
Apparatus according to claim 1 or 2, characterized by the fact that the housing (678) has a central fluid passage.
[0004]
4. Apparatus according to claim 3, characterized by the fact that the first and / or second openings (714) are in fluid communication with the central fluid passage.
[0005]
Apparatus according to claim 1 or 4, characterized by the fact that the apparatus has a first groove (84a) in the housing (678).
[0006]
6. Apparatus according to claim 5, characterized by the fact that the apparatus has a second groove (84b) on the housing (678).
[0007]
Apparatus according to claim 5 or 6, characterized in that the first opening (714) is at least partially in the first groove (84a).
[0008]
Apparatus according to any one of the preceding claims, characterized in that the apparatus has a balloon (650) at least partially within the housing (678).
[0009]
9. Apparatus according to claim 8, characterized by the fact that the balloon (650) is attached to the housing (678).
[0010]
Apparatus according to any one of the preceding claims, characterized by the fact that it has a tube that extends along the housing (678) on the longitudinal geometric axis.
[0011]
11. Apparatus according to any of the preceding claims, characterized by the fact that the housing (678) is non-malleable.
[0012]
Apparatus according to any one of the preceding claims, characterized by the fact that the strips (5703) are configured so that they are aligned with the first groove (84a) and the second groove (84b).
[0013]
Apparatus according to claim 12, characterized in that the first groove (84a) has a first inner groove first, a second inner first groove and an outer first groove between the first inner groove first groove and the second inner groove and / or wherein the second groove (84b) has a first inner groove second, a second inner groove second and an outer groove second groove between the first inner groove second groove and that second inner groove of second groove, the strips (5703) being entirely aligned between the inner and outer folds.
[0014]
Apparatus according to any one of the preceding claims, characterized in that the balloon (650) has a first cell (691a) and a second cell (691b) in a single cross-section of the inflatable structure.

类似技术:

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公开号 | 公开日 | 专利标题

---

BR112015008571B1|2021-01-26|inflatable structure device for use as a reinforced inflatable medical device

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US10926066B2|2021-02-23|Inflatable medical devices

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JP6335886B2|2018-05-30|Inflatable medical device

---

JP2015518776A5|2015-08-13|

同族专利:

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公开号 | 公开日

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AU2013331124B2|2017-11-09|

---

EP3366262B8|2019-09-11|

---

CN104853696B|2018-06-22|

---

EP2908779B1|2018-04-18|

---

RU2680958C2|2019-03-01|

---

NZ707155A|2017-09-29|

---

EP3366262B1|2019-08-07|

---

WO2014063039A1|2014-04-24|

---

IN2015DN02470A|2015-09-04|

---

RU2015116114A|2016-12-10|

---

KR102235247B1|2021-04-02|

---

KR20150071704A|2015-06-26|

---

US20150272732A1|2015-10-01|

---

CA3097484A1|2014-04-24|

---

WO2014063039A4|2014-07-31|

---

NZ735457A|2019-05-31|

---

EP3366262A1|2018-08-29|

---

US10799348B2|2020-10-13|

---

CA2885061A1|2014-04-24|

---

KR102172813B1|2020-11-03|

---

AU2013331124A1|2015-05-07|

---

CN104853696A|2015-08-19|

---

EP3510974A1|2019-07-17|

---

EP2908779A1|2015-08-26|

---

CA2885061C|2021-10-26|

---

BR112015008571A2|2017-07-04|

---

KR20200124777A|2020-11-03|

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法律状态:
2018-11-21| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|

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2020-03-24| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|

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2020-12-01| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

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2021-01-26| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 18/10/2013, OBSERVADAS AS CONDICOES LEGAIS. |

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