inflatable medical devices

专利摘要:
INFLATABLE MEDICAL DEVICES. The present invention relates to an inflatable structure for use in biological lumens and methods of making and using it are described. The structure may have an inflatable balloon surrounded by a wrapper. The casing may have proximal and distal conical necks, longitudinally oriented grooves, and openings at the proximal and distal ends of the casing. The openings can be chamfered in the grooves in the bottlenecks. The casing may also have fiber reinforcing walls.
公开号:BR112013018416B1
申请号:R112013018416-7
申请日:2012-01-18
公开日:2020-11-17
发明作者:Alexander Q. Tilson；Paul J. Dreyer；Mitchell C. Braham；Mark C. Scheeff；Charles S. Love；Garrett J. Gomes；Jonathan Kurniawan
申请人:Loma Vista Medical, Inc.；
IPC主号:

专利说明:

CROSS REFERENCE TO RELATED REQUESTS
[001] The present application claims the priority of U.S. Interim Orders Nos. 61 / 433,896 deposited on January 18, 2011; and 61 / 486,720 deposited on May 16, 2011, in which both are incorporated herein by reference. BACKGROUND 1. Technical Field
[002] Inflatable medical devices and methods for making and using them are described. More strictly, invasive medical balloons, such as those used for transcutaneous valve implantation in the heart, are described. For example, those balloons used for transcatheter aortic valve implantation.
[003] Inflatable structures are widely used in medical procedures. A structure is inserted, typically 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 within the body when the structure inflates.
[004] Inflatable structures can be used on heart valves, including during Aortic Balloon Valveplasty (BAV) and Transcatheter Aortic Valve Implantation (TAVI). The structures can be used to open a stenosed aortic valve. A stenosed valve can have hard calcified lesions that can tend to tear by puncturing a structure. In addition, a precise diameter of the inflated structure can be desired for increased safety and control.
[005] Inflatable structures can be used to move a plaque or constriction out of 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 this procedure, an inflatable structure at the distal end of the catheter is placed in an obstruction. As the structure is inflated, the constriction is dilated, resulting in an improved flow of liquid (such as blood) or gas (such as air).
[006] Inflatable chain structures or typical can be balloons. When a typical balloon inflates, it can block a lumen in the body. For example, a typical balloon can block blood flow in the vasculature or air in the airways. Blocking this vital supply of liquid or gas can cause health problems in the short or long term for the patient. This block can minimize the time that the doctor can keep an balloon inflated during the medical procedure.
[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. It can also generate enough force to expel the balloon from the aortic valve. Finally, typical balloons provide weak dimensional control (particularly diametric) and do not resist well when lacerating and puncturing (from, for example, aortic calcifications).
[008] Alternatively, the doctor may use rapid cardiac stimulation (artificially accelerating the peak of normal heart beats) during BAV and / or TAVI to minimize the formation of pressure and forces in the balloon. However, rapid beats carry a risk for the patient as well. Even with rapid beats, typical balloons can only be inflated for a few seconds before being removed and still suffer from low dimensional control and stiffness.
[009] A balloon or an inflatable structure is desired that can maintain the flow of liquid or gas while providing precise control and being highly resistant to tearing and puncturing. SUMMARY OF THE INVENTION
[0010] An inflatable medical device such as an inflatable device is described. The apparatus may have a housing having a longitudinal housing 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 larger than the diameter of the second neck of the first neck. The first end of the first neck can be adjacent to the central section.
[0011] The device can have a balloon at least partially inside the housing. The balloon can be attached to the wrapper.
[0012] The casing may have a longitudinal casing axis and a central fluid passage. The central fluid passage can be radially inside the balloon with respect to the longitudinal axis of the casing. 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's surface area can be concentric (that is, have the same radius center of curvature) with the wrapper.
[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 apparatus may have a first groove in the housing. The first groove may have a first inner crease of the first groove, a second inner crease of the first groove, and an outer crease of the first groove between the first inner crease of the first groove and the second inner crease of the first groove. The device may have a first opening. The first opening may be at least partially in the first groove. The first opening can be arranged with respect to not going through the outer fold of the first groove.
[0014] The first neck section can have a stiffness section of the first neck. 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 apparatus may have a tube extending along the longitudinal axis of the enclosure. The central fluid passage can be between the tube and the inner radius of the balloon in relation to the longitudinal axis of the casing. The tube may have a lumen extending through it.
[0016] The first neck section can have an average wall thickness of the first neck section. The central section can have an average wall thickness of the central section. The average wall thickness of the first neck section can be greater than the average wall thickness of the central section. The first streak can be in the first neck section.
[0017] At least 30% of the envelope's perimeter may be concentric with the balloon's 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 envelope perimeter may be in contact with the cells.
[0018] The balloon can have a first cell and a second cell in a single cross section of the inflatable structure. At least 5% of the balloon's surface area may be in contact with the wrapper.
[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 reduced configuration. The second groove may have a first inner groove of the second groove, a second inner groove of the second groove, and a second outer groove of the groove between the first inner groove of the second groove and the second inner groove of the second groove. The device may have a second opening. The second opening may be at least partially in the second groove. The second opening may be arranged so as not to pass through the second external fold of the groove.
[0020] The casing 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 second diameter of the end of the second neck. The diameter of the first end of the second neck may be larger than the second diameter of the end of the second neck. The first end of the second neck can be adjacent to the central section.
[0021] The device may have a second opening in 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 diameter of the central section. The diameter of the center section can be constant over the length of the center section. The balloon may be at least partially in the central section of the wrapper.
[0023] The wrapper may have a wrapper wall having a fiber. The enclosure may be incompatible. The wrapper 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 first and a second curved flexion section. The method may include inflating the balloon. The method may include perfusion of the aortic valve. Perfusion can include perfusion through the inflatable structure. Perfusion can occur while the balloon is inflated.
[0025] The opening may be in fluid communication with the central fluid passage.
[0026] The method may also include expansion of the expandable implant. Expansion of the expandable implant may include inflating the inflatable structure. At least some of the flow pathways 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 wrapper. The balloon can be at least partially inside the wrapper. The casing may have a longitudinal axis of the casing and a central fluid passage radially within the balloon with respect to the longitudinal axis of the casing. The housing may have a groove and an opening in 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 perfusion of the aortic valve. Perfusion can include perfusion through the inflatable structure.
[0028] A method for preparing the inflatable structure is described. The method may include making a wrapper. 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 cut openings in the first neck section. The method may include loading the balloon into the wrapper. The method may include pressing the balloon back into the wrapper. The method may include securing that balloon into the housing.
[0029] Preparing the wrapper may include applying a first film to the first neck section, and applying a second film to the first neck section. The preparation of the wrapper may include adding a first layer and a second layer to the wrapper. 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 wrapper. Compression may include forming the balloon in such a way that at least 5% of the balloon's circumference can contact the wrapper in the center section of the wrapper. Loading can include inserting the balloon through the opening.
[0030] Another method of preparing the inflatable structure is described. The method may include forming a balloon along a longitudinal axis of the balloon. Training can include flexing the balloon in a flexing section of the balloon. The method may also include attaching the balloon to a compression fitting. The compression fitting may have the same internal diameter as the housing. BRIEF DESCRIPTION OF THE DRAWINGS
[0031] Figure 1A illustrates a variation of the device.
[0032] Figure 1B illustrates a cross-sectional variation A-A of Figure 1.
[0033] Figure 2A illustrates a variation of the device.
[0034] Figure 2B illustrates a variation of the device.
[0035] Figure 2C illustrates a variation of the device.
[0036] Figures 3A to 3D illustrate variations of the device.
[0037] Figures 4 to 6 illustrate variations of the device.
[0038] Figure 7A illustrates a variation of the device in a partially reduced condition.
[0039] Figure 7B illustrates a D-D cross-sectional variation of Figure 7A.
[0040] Figure 7C illustrates a cross-sectional variation E-E of Figure 7A.
[0041] Figure 7D illustrates a variation of the device in a reduced condition.
[0042] Figure 8 illustrates a variation of the device.
[0043] Figures 9A to 9D illustrate variations of the device.
[0044] Figures 10A to 10B illustrate cross-sectional variations of B-B of Figure 1A.
[0045] Figures 11A to 11B illustrate cross-sectional variations of C-C of Figure 3C.
[0046] Figures 12 to 14B illustrate variations of the device.
[0047] Figures 15 to 18 illustrate variations of the device.
[0048] Figure 19 illustrates a method of preparing a variation of inflatable devices.
[0049] Figure 20A illustrates a variation of the device.
[0050] Figure 20B illustrates a variation of a tool for preparing a variation of the inflatable device.
[0051] Figure 20C illustrates a method of preparing a variation of the inflatable device.
[0052] Figures 21 to 22B illustrate variations of the device.
[0053] Figure 23A illustrates a variation of the device.
[0054] Figure 23B illustrates a cross-sectional variation F-F of Figure 23A.
[0055] Figure 24A illustrates a variation of the device.
[0056] Figure 24B illustrates a cross-sectional variation G-G of Figure 24A.
[0057] Figure 25A illustrates a variation of the device.
[0058] Figure 25B illustrates a cross-sectional variation H-H of Figure 25A.
[0059] Figure 26A illustrates a variation of the device.
[0060] Figure 26B illustrates a cross-sectional variation J-J of Figure 26A.
[0061] Figure 27A illustrates a variation of the device.
[0062] Figure 27B illustrates a K-K cross-section variation of Figure 27A.
[0063] Figure 27C illustrates a variation of Figure 27B in a reduced state.
[0064] Figure 27D illustrates a variation of a cross-sectional photo of Figure 27B.
[0065] Figure 27E illustrates a variation of a cross-sectional photo of Figure 27C.
[0066] Figure 28A illustrates a cross-sectional variation K-K of Figure 27A.
[0067] Figure 28B illustrates a variation of Figure 28A in a reduced state.
[0068] Figure 28C illustrates a variation of a cross-sectional photo of Figure 28A.
[0069] Figure 28D illustrates a variation of a cross-sectional photo of Figure 28B.
[0070] Figures 29 to 31A illustrate variations of the device.
[0071] Figures 31B to 31C illustrate details of an element shown in Figure 31 A.
[0072] Figure 32A illustrates a variation of the device.
[0073] Figure 32B illustrates a variation of a cross-section of the device shown in Figure 32A.
[0074] Figure 32C illustrates a variation of the device.
[0075] Figure 32D illustrates a variation of a cross section of the device shown in Figure 32C.
[0076] Figures 33A to 33B illustrate variations of the device.
[0077] Figure 34 illustrates a variation of the device in a reduced state.
[0078] Figures 35A to 35D illustrate variations of a fiber matrix.
[0079] Figure 36 illustrates a variation of a tool for preparing a variation of the inflatable device.
[0080] Figures 37A to 37C illustrate a variation of a method for preparing the device.
[0081] Figure 37D illustrates a cross-sectional variation L-L of Figure 37C.
[0082] Figures 38A to 38B illustrate the method for preparing the device.
[0083] Figures 39A to 39C are cross-sectional sections of variations of hemp fibers in various configurations during a preparation method.
[0084] Figures 40A to 40H illustrate a method of preparing a panel.
[0085] Figures 41A to 42C illustrate variations of a panel.
[0086] Figures 43A to 43B illustrate a method for preparing the device.
[0087] Figure 44 illustrates a method for preparing a device.
[0088] Figures 45A and 45B illustrate a method for preparing the device.
[0089] Figures 46A to 46B illustrate variations of a panel.
[0090] Figure 47 illustrates a variation of a method for removing the mandrel.
[0091] Figures 48A to 48C illustrate a method for preparing the device.
[0092] Figures 49A to 49F illustrate a method for preparing the device.
[0093] Figure 50 illustrates a variation of a distribution tool for the device.
[0094] Figure 51 illustrates a cross section of a variation of the device contracted inside a tube.
[0095] Figure 52 illustrates a cross section of a human's heart.
[0096] 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.
[0097] Figures 54A to 54E illustrate a variation of a method for using the device.
[0098] Figures 55A to 55F illustrate a variation of a method for using the device.
[0099] Figures 56A to 56C illustrate a variation of a method for using the device. DETAILED DESCRIPTION
[00100] Figures 1A and 1B illustrate a housing 678. Housing 678 may have a longitudinal axis of housing 26. Housing 678 may have a housing wall 684 having an average housing thickness 686.
[00101] The 678 enclosure can be a tube or a shield or combinations thereof.
[00102] Figure 1B illustrates a cross-section AA of the wrapper 678. The wrapper may have a proximal wrapper trunk 30 and / or a proximal wrapper file 34 and / or a center section 38 and / or a distal wrapper file 42 and / or a distal casing trunk.
[00103] Housing 678 may have a housing length 28. Housing length 28 may be the sum of lengths 32, 36, 40, 44 and 45. Housing 678 may have a housing trunk 30 having a housing trunk of casing 32. The length of the proximal trunk 32 can be from about 3 mm to about 15 mm, more closely about 10 mm. Casing 678 can have a proximal taper of casing 34 having a taper proximal to the length of casing 36. The proximal taper of casing 36 can be from about 0 mm to about 25 mm, more closely from about 10 mm to about 22 mm, even more narrowly from about 16 mm to about 20 mm. Housing 678 can have a central section 38 having a central length of section 40. The central length of central section 40 can be from about 0 mm to about 55 mm, more closely from about 30 mm to about 50 mm. Casing 678 can have a proximal taper of casing 42 having a proximal taper of casing 44. The proximal taper of casing 44 can be from about 0 mm to about 25 mm, more closely from about 10 mm to about 22 mm, even more narrowly from about 16 mm to about 20 mm. Housing 678 can have a distal housing trunk 43 having the proximal trunk length of housing 45. The length of proximal trunk 45 can be from about 3 mm to about 15 mm, more strictly about 10 mm. The length of the casing 28 can be from about 10 mm to about 250 mm, more strictly from about 50 mm to about 150 mm, even more strictly about 75 mm to about 125 mm.
[00104] Housing 678 may have an outer diameter of the central section of housing 50. Central section 38 may have a housing within radius 706 and a housing outside radius 708. Diameter 50 may be twice the outer radius of the enclosure 708. The central section 38 can be formed cylindrically, as shown. The outer diameter of the central section of the casing 50 can be from about 2 mm to about 40 mm, more strictly about 8 mm to about 30 mm, even more strictly from about 16 mm to about 28 mm, for example 26, 24 , 22 or 20mm.
[00105] The central section 38 can have an outer radius of enclosure 708. The external radius of enclosure 708 can have a maximum dimension in the longitudinal locus where the central section 38 meets conicities 34 or 42. The outer radius of enclosure 708 can have a minimum dimension in the longitudinal center of the central section 38.
[00106] Housing 678 can have a proximal trunk diameter of housing 31. The diameter of proximal trunk of housing 31 can be from about 0.5 mm to about 8 mm, more strictly about 1 mm to about 5 mm, for example example about 3mm. Housing 678 may have a distal trunk diameter of housing 41.0 distal trunk diameter of housing 41 may be from about 0.5 mm to about 8 mm, more strictly about 1 mm to about 5 mm, for example about 3 mm.
[00107] Enclosure 678 may have one or more neck sections adjacent to and extending from central section 38. For example, a proximal neck section may be a proximal taper of envelope 34 extending proximally from central section 38. A section of distal neck can be a distal taper of casing 42 extending distally from 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 dimensions or different from that of 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 diameter of the first neck end 61. The second neck end 62 can have a diameter of a second end 63. The diameter of the first neck end 61 may be larger than the diameter of the second neck end 63. The neck sections can be tapered, conical, multi-striated (for example, having a plurality of concave portions and a plurality of convex in each neck section), or combinations thereof.
[00108] Housing 678 may have an inner lumen 154A and an outer lumen 154B. The inner lumen 154A can be formed by the second hollow rod 2000B. The inner lumen 154A can provide a lumen through the entire housing. The inner lumen 154A may allow a guide wire to pass through the interior of the housing. The outer lumen 154B can connect to the inflation / deflation slots of the balloon 654. The outer lumen 154B can be formed between the inner wall of the first hollow rod 2000A and the outer wall of the second hollow rod 2000B.
The distal taper angle 90A can be from about 0 to about 90 °, more strictly about 50 ° to about 20 °, even more strictly about 45 ° to about 30 °, for example about 35 °. The taper angle of the proximal stem 90b can be from about 0 to about 90 °, more strictly about 50 ° to about 20 °, even more strictly about 45 ° to about 30 °, for example about 35 °.
[00110] The first hollow rod 2000a can have a distal gap of hollow stem 54. One of the inflation / deflation loops of balloon 654 can couple with the distal gap of hollow stem 54.
[00111] The 678 housing can be resilient (that is, elastic) or non-compatible (that is, non-elastic).
[00112] If housing 678 is configured to be patentable and used as a balloon, housing 678 may have an explosion pressure greater than 3 atm, more strictly, greater than 10 atm, even more strictly greater than 15 atm . If housing 678 is configured to be patentable and used as a balloon, housing 678 can have a diametric elasticity of less than 0.35mm / atm, more strictly less than 0.2mm / atm, even more strictly less than 0.03mm / atm, even more strictly less than 0.02mm / atm.
[00113] The wall of the 684 enclosure may have high puncture resistance. For example, when a 678 housing is pressurized to about 4 atm and a 1 mm calibrating pin is guided into the balloon around Imm / sec, the pin may need to exert more than 13 newtons of force to puncture the balloon wall, more strictly more than 18 newtons. The wall of the 684 enclosure is not compatible. The wall of the enclosure 684 may have a polymer. The wall of the casing 684 may be fluid tight (for example, not porous enough to prevent water, and / or saline, and / or air or osmosis transfer through the wall of the casing 684). The wall of the enclosure 684 can have a wall thickness of about 0.04 mm to about 0.8 mm.
[00114] Figure 2A shows a wrapper 678 with first, second and third taper reinforcements of wrapper 862a, 862b and 862c respectively in proximal taper 34 and fourth, fifth and sixth taper reinforcements of wrapper 862d, 862e and 862f respectively in distal taper . Each of the 862 casing taper reinforcements can have different sizes, for example, different lengths. In Figure 2A, casing taper reinforcements 862 can be arranged in such a way that a portion of each reinforcement 62 is visible. Casing reinforcements 862 can cover part or all of the conicities 34 and 42, trunks 30 and 43 the central section 38 of the casing. Casing taper reinforcements 862 can have casing taper reinforcing lobes 866. Casing taper reinforcing lobes 866 can be semicircular in shape and extend in the longitudinal direction of the casing, as shown in Figure 2A. Casing taper reinforcements 862 can increase the stiffness of the casing wall 684 in areas covered by casing taper reinforcements 862. For example, one or both of the neck sections 34 and / or 42 may have a greater stiffness than the section central 38. Taper reinforcements of shell 862 may be panels 196. The wall of shell 684 may comprise a polymer such as PET, Mylar, Nylon, Pebax, polyurethane or combinations thereof.
[00115] Figure 2B shows 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 to pass through the housing. plane of the enclosure wall 684. The openings of the enclosure 714 may be in fluid communication with the exterior and the interior of the enclosure 678. Openings of the enclosure 714 may be circular, elliptical, rectangular, teardrop-shaped, hexagonal or other. shapes or combinations thereof. Openings of the casing 714 may be located in the proximal trunk of the casing 30, the proximal taper 34, the central section 38, the distal taper 42 or the distal casing trunk 43 or combinations thereof. There can be less than 500 openings 714 in housing 678, more strictly less than 100, even more strictly less than 25. For example, it can 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.
[00116] Figure 2C illustrates that housing 678 can have teardrop-shaped openings in housing 714. Housing openings 714 can be traversed by housing taper reinforcements 862. The portion of the edge of the housing opening 714 that extends further towards the longitudinal center of the casing 678 can align with the portion of the taper-reinforcing lobe of the casing 866 which extends further towards the longitudinal center of the casing 678 as shown in Figure 2C. In this way, opening 714 can be angularly aligned with lobe 866.
[00117] Figures 3A, 3B, 3C and 3D illustrate that sheath 678 may have reinforcement fibers 86. Second or latitudinal reinforcement fibers 86a may be perpendicular to the longitudinal axis of sheath 26. Fibers 86a may be a continuous fiber wound in around the piece (an "arc wind"). Fibers can be applied with a certain density. For example, the fibers can be applied in 100 winds (winds) per 1 inch (25.4 mm). The number of turns per inch is often referred to as the "peak" of the wind. The peak may vary over the length of the housing. Fibers 86a can be omitted entirely from portions of wrapper 678.
[00118] First or longitudinal reinforcement fibers 86b can be parallel to the longitudinal axis of the wrapper 26. The fibers can be applied with a certain density. For example, there may be 50 fibers 86b per 1 inch (25.4 mm) around the circumference of wrapper 678. The density of fiber 86b can vary around the circumference of wrapper. The fibers 86b can be omitted entirely from the portions of the wrapper 678.
[00119] The angle between fibers 86a and 86b can be approximately perpendicular and may not change between inflation and deflation.
[00120] Figures 3A, 3B, 3C and 3D show that the casing may have a longitudinal proximal zone 618a, a central longitudinal zone 618b and a longitudinal distal zone 618c. Proximal zone 618a can cover proximal taper 34 and proximal trunk 30. Distal zone 618c can cover distal taper 42 and distal trunk 43. Central zone 618b can cover central section 38. Fibers 86a and / or 86b they may be present or absent in zones 618a and / or 618b and / or 618c. The peak of fiber 86a can be different in each of zones 618a, 618b and 618c. The peak of fiber 86a can vary within each of zones 618a, 618b and 618c. The density of fiber 86b can be different in each of zones 618a, 618b and 618c. The density of 86b can vary within each of zones 618a, 618b and 618c.
[00121] 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. Fibers 86a may 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 peak of fibers 86a in zone 618b may be less than the peaks in zones 618a and 618c. The peaks in zones 618a and 618c can be substantially equivalent. For example, the peak in zones 618a and 618c can be 128 turns per inch, while the peak in zone 618b can be 100 turns per inch. The minor peak fibers 86 in a zone 618 can cause the shell wall to structurally fail in the lower peak zone 86 before peak zones 86 with a higher fiber peak. In the example above, zone 618b can explode before zones 618a and 618c when the wall of enclosure 684 experiences structural failure. Lower peak 618 zones may be more compatible and foldable than higher peak 618 zones. A zone 618 can have a peak 10% lower than the rest of the piece, more strictly a peak 20% lower than the remainder of the wall of enclosure 684.
[00122] The boundaries between zones 618a and 618b and between 618b and 618c can move. For example, the boundaries can be located in the conicities of the casing 34 or 42 or in the central section 38. Second or latitudinal reinforcement fibers 86a may or may not be a single fiber continuously wound.
[00123] Figure 4 reveals that the first reinforcement fiber 85a can be at the first reinforcement fiber angle in relation to the longitudinal axis of the wrapper 26. For example, the first reinforcement fiber angle can be at 10, 15, 20, 25, 50, 55 or 60 degrees to the longitudinal axis of the enclosure. The second reinforcement fiber 85b may be one second from the angle of the reinforcement fiber with respect to the longitudinal axis of the wrapper 26. For example, the second angle of the reinforcement fiber may be at 10, 15, 20, 25, 50, 55 or 60 degrees to the longitudinal axis of the enclosure. The second reinforcement fiber 85b may have an equal but opposite angle to the 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 for the longitudinal axis of the wrapper. The third reinforcement fiber 85c can be substantially perpendicular to the longitudinal axis of the sheath. The third reinforcement fiber 85c can be omitted from the wall of the wrapper 684.
[00124] Figure 5 shows that the longitudinal reinforcement fiber 86b can be parallel to the longitudinal axis of the envelope 26. The second longitudinal reinforcement fiber 87b can be parallel to the longitudinal axis of the envelope 26. Fibers 86b and 87b can be separated by the areas where longitudinal fibers 614 are missing. Areas 614 can separate fibers 86b and 87b by 2 mm, more strictly less than 1mm, even more strictly less than 0.25mm. The areas 614 can be distributed on the surface of the enclosure in such a way that no area substantially overlaps substantially over any other area in the enclosure. Areas 614 can be distributed in such a way that the latitudinally adjacent areas have no longitudinal overlap. Areas 614 can be distributed in a regular pattern, repeated around the casing diameter sufficient to prevent any fiber from coming in contact from one end of the casing to the other while still maximizing the longitudinal strength of the casing. Fibers 86B and 87B can be less than 80% long than the wrapper, more strictly less than 75%, even more strictly less than 70%, even more strictly less than 65%, even more strictly less than 60%. The second or latitudinal reinforcement fibers 86a can be substantially perpendicular to the longitudinal axis of the shell 26.
[00125] Figure 6 illustrates that the longitudinal reinforcement fiber 86b can be parallel to the longitudinal axis of the envelope 26. The second longitudinal reinforcement fiber 87b can be parallel to the longitudinal axis of the envelope 26. Fibers 86b and 87b can overlap in the fiber area reinforcement 612. The overlapping area of the reinforcement fiber 612 can form an arc-shaped area that can completely surround the central section 38.
[00126] Figure 7A reveals that a wrapper 678 can be pleated to form ribs 84, for example, four, five, six, seven or eight ribs 84, such as first rib 84a, second rib 84b. The ribs 84 can be made of accordion folds, box folds, cartridge folds, ribbed folds, honeycomb type folds, knife folds, laminated folds, or combinations thereof. The pleat can be heated and / or formed by pressure and / or the fiber of reinforcements and / or panels can be oriented to form the ribs 84. Pleating the wrapper 678 can create the first row of internal pleats 822a and the second row of pleats inner pleats 822b and outer pleat lines 826a between inner pleat lines 822a and 822b. Pleat lines 822 and 826 can be areas where the wall of the enclosure 684 can be wrinkled. Inner pleat lines 822 can be positioned radially inward from outer pleat lines 826 when the housing collapses as shown in Figure 7A. Each groove 84 can be the portion of the casing wall 684 between two rows of inner pleats 822. The openings of the casing 714 can be between adjacent rows of outer pleats 826 and interrupt an inner row of pleats 822 as shown. Openings 714 may or may not cross a line of internal pleats 822. Openings 714 may or may not cross a line of external pleats 826.
[00127] Figure 7B illustrates a D-D sectional view of Figure 7A. The section of the section view showing aperture 714 is highlighted with a dotted line. The width of the opening 714 in the DD cut can be divided into the partial width of the first opening 830 and the partial width of the second opening 834. The partial width of the first opening 830 can be about the same partial width as the second opening 834. For example, the opening 714 it can be centered on the line of internal pleats 822. The partial width of the first opening 830 can be different from the width 834, for example, equal to three times the width 834, thereby placing the opening 714 outside the center of the line of internal pleats 822. Opening 714 may be entirely between two adjacent outer pleat lines 826, for example, between outer pleat lines 826a and 826b.
[00128] Figure 7C illustrates an E-E section view of Figure 7A. The central area of the housing may have openings or not (as shown) interrupting the wall of the housing 684, as shown in section E-E.
[00129] Figure 7D reveals that the pleated shell 678 or annular balloon structure 682 can be collapsed into a compact form with a reduced diameter. The pleat may allow housing 678 or frame 682 to collapse and expand in a repeated and regular manner. In this collapsed state, openings 714 can be fully (as shown) or partially covered or hidden by collapsed streaks 84, for example, the second streak 84b can cover or hide opening 714. Covering openings 714 can give collapsed housing 678 or balloon annul 682 an interrupt-free external surface of the openings 714. The diameter of the structure can be minimized and the openings can be covered by the surface of the structure before and during the insertion of the structure into the body during a medical procedure.
[00130] An annular balloon structure 682 can be subjected to a first cycle and a second cycle of inflation and deflation. 682 annular balloon structure can have the same number of pleats after the first and second cycles of inflation and deflation. For example, the angle of folded position of the pleats, and the number and locations of the pleats may remain more or less constant after a cycle of inflation and deflation.
[00131] A material, such as a gas or liquid, can flow from the outer casing 49 through openings in the casing 714 into a casing taper (e.g., distal taper 42), pass through the inner casing 47 and flow into outside the openings of the casing 714 in the other taper of the casing (for example, the proximal tapering 34) to the outer casing 49. Figure 8 shows that the openings 714 can be filled with unidirectional flow valves or flaps for opening the casing 718, for example For example, openings 714 can be filled with housing opening flaps 718 at the proximal taper 34. Housing opening flaps 718 can be configured in such a way that they will partially or completely cover openings 714 when there is no material flowing through the interior housing 47 to the proximal end, for example, of the outer shell 49. When the material is driven to flow with sufficient pressure from the inner shell 47 to the outer casing 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. Flaps 718 can act as one-way or two-direction valves . For example, flow and flow pressure (e.g., from a body fluid such as blood) through openings 714 can be generated by a beating heart during a medical procedure. The tabs 718 can be a temporary or permanent replacement for a heart valve (such as the aortic valve) during a medical procedure. The flaps may be made of a polymer film or may be made similar to the wall of the 684 enclosure described herein, or may be made of a compatible material such as, for example, an elastomer. The flap can be made integral to the wrapper by cutting the opening 714, but omitting the circumferential cut, for example, leaving a joint 719.
[00132] Figure 9A shows a pattern for marker wire 190. Marker wire 190 can be wrapped around housing 678. Marker wire 190 can partially cover the distal and proximal ends of central section 38 of housing 678.
[00133] Figure 9B shows that the marker wire 190 can be wrapped around the wrapper in both taper 42 and proximal 34 of the wrapper 678. The marker wire 190 can be wound up to the distal and proximal limits of the central section 38 without any substantial amount of the yarn being placed in the central section 38. The marker yarn can be wound in a helical pattern in both directions in the wrapper or be wound in a single direction. The angle crossing the marker wire 191 between two layers of marker wire can be less than 20 degrees, more strictly less than 10 degrees, even more strictly less than 6 degrees.
[00134] Figure 9C reveals that the wrapper 678 may have a marker wire 190 involving approximately the entire length of the center section 38.0 marker wire 190 may be centered on the center section 38. The marker wire 190 may cover only a portion of the center section 38. For example, marker wire 190 may cover more than 70% of central section 38, more strictly more than 80%, even more strictly more than 90%. The marker wire 190 can cover a portion of the distal taper 42 and proximal taper 34. For example, the marker wire 190 can cover 100% of the distal taper 42 and proximal taper 34, more strictly more than 50%, even more strictly more than 25. %. The marker wire 190 may be a latitudinal reinforcement fiber 86a.
[00135] Figure 9D reveals that wrapper 678 may have a marker wire 190 substantially wrapped the entire length of wrapper 678.
[00136] The peak of marker wire 190 may be about 150 turns per 1 inch (25.4mm), more strictly less than about 75 turns per 1 inch (25.4mm), even more strictly less than about 25 turns per 1 inch (25.4mm), even more strictly less than about 10 turns per 1 inch (25.4mm). The peak of the marker wire 190 can be about 6, 5, 4, 3 or 2 turns per 1 inch (25.4mm).
[00137] Figure 10A reveals that the casing wall 684 in section B-B or in other sections taken through a single casing 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 fused to form an annular balloon structure 682. A fiber matrix can comprise a layer 72 or a panel 196.
[00138] Reinforcement fibers 85, 86 and 87 can be a monofilament 274 and / or a trailer 270. A trailer 270 can contain one or more monofilaments 274. The reinforcement fiber 86 can be a marker wire 190. A matrix of The fiber can have one, two or more reinforcement fibers 86 running substantially parallel to each other and embedded in an adhesive 208. The substantially parallel reinforcement fibers 86 can be positioned within the adhesive in such a way that they are touching each other along their lengths. The substantially parallel reinforcement fibers 86 can be positioned in such a way that there is adhesive separating each fiber along its length.
[00139] Figure 10A illustrates a layer 72 with a fiber matrix having a layer width 210 in cross section. The width of layer 210 can include a number of monofilaments 274. Layer 72 can have a fiber density of linear quantity measured, for example, as the number of fibers 86 per unit of layer width 210. The fiber density of linear quantity can be equal to or greater than about 500 monofilaments 274 per inch, more strictly equal to or greater than about 1000 monofilaments 274 per inch, more strictly equal to or greater than about 2000 monofilaments, 274 per inch, still more strictly equal to or greater than about 4000 monofilaments 274 per inch. For example, a linear monofilament density 274 can be from about 1,000 monofilaments 274 per inch to about 2,000 monofilaments 274 per inch.
[00140] Layer 72 with a fiber matrix can have a layer thickness 216 from about 1 pm (0.00004 in.) To about 50 pm (0.002 in.), More strictly about 8 pm (0 , 0003 in.) At about 25 pm (0.001 in.), Even more strictly from about 10 pm (0.0004 in.) To about 20 pm (0.0008 in.). Monofilaments 274 or fibers 86 may have a non-circular cross-section, for example, an oval cross-section.
[00141] Part or all of the wall of enclosure 684 may have a quantitative volumetric density of monofilaments 274 measured, for example, as the number 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, more strictly equal to or greater than about 250,000 274 monofilaments per square inch, more strictly equal to or greater than about 1,000,000 274 monofilaments per square inch, even more strictly equal to or greater than about 4,000,000 274 monofilaments per square inch. The amount of the fiber area can be about 25% of the cross-sectional area of a wall, more strictly about 50%, more strictly about 75%.
[00142] The proportion of the volume of a fiber matrix to the volume of monofilaments 274 can be about equal to, or greater than about 15%, more strictly equal to or greater than about 30%, more strictly equal a or greater than about 50%, even more strictly equal to or greater than about 75%.
[00143] Figure 10B reveals that the outer layer 72a and the inner layer 72b can be polymer films, for example, as described below. In any variation, the polymer films can be the same or different polymers, or any combination thereof. The first layer of the medium 72c can have a fiber matrix, for example, with the fibers oriented as longitudinal fibers 86b. The second layer of the medium 72d may have a fiber matrix, for example, with the fibers oriented with latitudinal fibers or arc 86a. The third layer of the medium 72e can be an adhesive. The fourth layer of the medium 72f can be a radiopaque layer, such as a plate or a metal wire.
[00144] Figure 11A is a cross section taken in C-C in Figure 3C. Figure 11A shows that the outer layer 72a and the inner layer 72b can be polymer films, for example, as described below. The first layer of the medium 72c can have a fiber matrix, for example, with the fibers oriented as longitudinal fibers 86b. The second layer of the medium 72d may have a fiber matrix, for example, with the fibers oriented as an arc or latitudinal fibers 86a. The third layer of the medium 72e, the fourth layer of the medium 72f and the fifth layer of the medium 72g can be wrapper taper reinforcements 862. Wrapper taper reinforcements can be of uneven longitudinal lengths as shown in Figure 11 A. An adhesive can be placed between any of the layers 72 shown. Any of the layers 72 shown in Figure 11A can be omitted.
[00145] As shown in Figure 11A, proximal tapering 34 or distal tapering 42 may have a first medium wall thickness 686a. Central section 38 may have an average shell thickness of the second wall 686b. First average wall thickness 686a may be greater than the second average wall thickness 686b.
[00146] The enclosure wall 684 of proximal tapering 34 and / or distal tapering 42 may be the same or more rigid per unit area than the enclosure wall 684 of central section 36. For example, the enclosure wall 684 of the proximal tapering 34 and / or distal tapering 42 may have a measured flexural stiffness of about two, about three, or about five times greater per unit area than the wall of the enclosure 684 of the central section 36.
[00147] Figure 11B is a cross section taken at C-C in Figure 3C. Figure 11A illustrates that taper reinforcements of shell 862 can be placed closer to the inner layer 72b than to the outer layer 72a.
[00148] A layer 72 can be a panel 196. Layers 72 and / or panels 196 can comprise a polymer. The polymer can be a film. The thickness of the polymer films can be from about 2 pm to about 50 pm, more strictly from about 2 pm to about 18 pm, even more strictly from about 4 pm to about 12 pm. Films can be metallized or coated to change the properties of their surfaces. Metallization or coating can take place before or after a film is formed. Films can be treated chemically or by plasma or by corona or by 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, co-polyester, ECTFE, Solef, EPTFE, FEP, Kapton, Pebax, HDPE, LDPE, PET, Mylar, micrton, nailon, PEEK, PEN (polyethylene and naphthalate), Tedlar, PVF, Polyurethane, Thermoplastic Polyurethane (TPU), Parylene or combinations thereof.
[00149] Reinforcement fibers 86 can be of high strength and non-elastic. Non-elastic fibers can have a failure stress of less than 10%, more strictly less than 5%. High strength fibers can have a higher tensile strength greater than 1.8 GPa (260 ksi), more strictly greater than 2.4 GPa (350 ksi), even more strictly greater than 2.9 GPa (420 ksi) .
[00150] Reinforcement fibers 86 may have a fiber or monofilament diameter 212, for example, from about 1 pm to about 50 pm, for example less than about 25 pm, more strictly less than about 20 pm.
[00151] The reinforcement fibers 86 may have a thread or threads. Reinforcement fibers 86 can be a metal. Yarn can have a failure resistance of less than 10%, more strictly less than 5%, even more strictly less than 2%. The wire can be annealed or tempered to adjust its mechanical properties. The wire may have a tensile strength of more than 150KSI, more strictly greater than 250KSI, more strictly greater than 400KSI
[00152] The wire can be ductile and have a resistance to defect greater than 20%, more strictly greater than 40%, even more strictly greater than 80%. The ductile wire can allow the 678 housing to bend without breaking the wire.
[00153] The wire can be less than 25um in diameter. The wire can be substantially rectangular and less than 25um in thickness 1068, more strictly less than 15um in thickness 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 strictly greater than or equal to fence 5, more strictly greater than or equal to about 10. The wire it can be a plate in which the ratio of the wire width 1072 to the wire thickness 1069 can be greater than or equal to about 100, more strictly greater than or equal to about 300, more strictly greater than or equal at about 500. The density of the wire may be greater than about 2.4 g / cmA3, more strictly greater than about 6.9 g / cmA3, more strictly greater than about 15 g / cmA3.
[00154] Reinforcement fiber 86 or wire can be substantially radiopaque when used under a flourosocope as part of a medical procedure on the human body. The use of radiopaque material, such as radiopaque fibers 86, may enable the physician to use a means of inflating, such as saline, which is not radiopaque when inflating a 650 balloon or 682 annular balloon structure. The use of radiopaque material, such as radiopaque fibers 86 can enable the physician to see how well the structure of balloon 682 is well folded or folded when placed on the human body. The fibers 86 can be substantially radiant. A fiber matrix can have the same or different sizes and materials of fibers 86 within the same fiber matrix.
[00155] The reinforcement fibers 86 or the threads can be coated. The coating can enhance adhesion. The coating can be an adhesive 208. The adhesive 208 can be melted as part of the process of applying reinforcement fibers 86 to a 678 wrapper.
[00156] A reinforcement fiber 86 may comprise Vectran, PBO (p-phenylene-2,6-benzobisoxazole), Zylon, Spectra, Dyneema, UHMWPE, Conex, Technora, Twaron, Dacron, Polyester, Compet, Nylon, PEEK, PPS , Boron, Cermic, Kevlar, aramid, Carbon, Carbon Fiber, Inorganic Silicon, glass, fiberglass, Tungsten and its alloys, Tantalum and its alloys, Molybdenum and its alloys, bismuth and its alloys, gold and its alloys, silver and its alloys, platinum and its alloys, iridium and its alloys, stainless steel (for 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, sludge and its alloys, Nitinol alloys or combinations thereof.
[00157] Adhesive 208 can be a thermoset material, a thermoplastic material, or a combination thereof. Adhesive 208 may 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 nailon, 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.
[00158] Any of the layers 72 or panels 196 can be leak-proof, waterproof, airtight, MMA (Methyl methacrylate) - resistant, MM A-release, or combinations thereof.
[00159] Magnetic resonance imaging enhancement materials, such as contrast agents, can be added to adhesive 208 or any layer 72 or panel 196. Magnetic resonance imaging enhancement materials can intensify balloon visualization during a magnetic resonance imaging (MRI) procedure. For example, the magnetic resonance imaging enhancement material can be gadolinium, Omniscan, Optimark, ProHance, Magnevist, Multihance, or combinations thereof.
[00160] Any of the layers 72, for example, the outer layer 72a, can be tinted or dyed in a visible spectrum color. For example, a pigment, coloring additive, dispersions or other odor agents, such as a Plasticolors coloring additive (Ashtabula, Ohio) can be added. A paint or coating can be added to the outer surface of the 678 housing.
[00161] The color can be selected for brand, market differentiation, as an indication of the type of device, the size of the device, or combinations thereof. For example, devices having a selected diameter, length, pressure rate, indication or clinical efficiency, other common metric performances, or combinations thereof, can be dyed with a specific color color (for example, green for a first type of device, red for a second type of device).
[00162] Layers 72 may have one or more optical fibers. The optical fiber can be a voltage sensor. The voltage sensor can monitor the mechanical status in real time. Fiber optics can guide the distribution of light within the body. The optical fiber can visualize a target site (for example, gathering light from the body to produce a visual image).
[00163] Figure 12 shows that a balloon 650 can have a main balloon diameter 662, a balloon length 666 and a balloon wall thickness 658. The balloon can have a conical balloon section 652 at either end. The conical sections can connect the diameter of the balloon to the inflation / deflation openings of the 654 balloon. The 650 balloon can be inflated by placing a pressurized fluid, such as saline, contrast, water or a gas, in both inflation / deflation ports. or pouring fluid into one of the inflation / deflation openings 654 while closing the other inflation / deflation openings 654.
[00164] The balloon 650 can have a main diameter 662 of about 1mm to about 15.3mm, more strictly about 4mm to about 12mm, even more strictly about 6mm to about 10mm. The wall thickness of balloon 658 can be about 5 pm to about 50 pm, more strictly about 8 pm to about 25 pm, even more strictly about 8 pm to about 15 pm. The length of the 666 balloon 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.
[00165] Figure 13 shows that balloon 650 may have balloon segments 656a-656f. The balloon segments 656a-656f can form a lumen of continuous internal inflation / deflation. Each balloon segment 656 can be joined by a balloon flexion section 670a-670e to the adjacent balloon segment 656. The balloon flexion sections 670 can have a balloon flexion section diameter less than 664 than the main diameter balloon 662 (i.e., balloon segments 656). Balloon 650 may have a balloon bending section diameter of 664 from about 1mm to about 10mm, more strictly about 2mm to about 6mm, even more strictly about 2.5mm to about 5mm. Balloon 650 may have a bending diameter of balloon 664 in diameter of about 3.3 mm. Multi-segment balloon conical section 653 can connect balloon flex sections 670 to balloon segments 656. Balloon 650 can bend or flex in balloon flex sections 670 before curving 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.
[00166] 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 make 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.
[00167] Heat shrink tubing can be used to form balloon 650. For example, balloon 650 can be formed by placing the heat shrink tubing over 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.
[00168] The balloon 650 can be formed by depositing a material on a mandrel or inside 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 by various techniques of physical vapor deposition, by dipping, coating or spraying. 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.
[00169] The balloon may comprise a fiber and be designed and manufactured as described in US Provisional Patent Application No. 61 / 363,793, filed on July 13, 2010, and PCT Application No. PCT / US2011 / 43925, filed on 13 July 2011, both of which are incorporated by reference in their entirety.
[00170] Figure 14A shows a balloon with balloon restrictions 674 involving the length of balloon 650. Figure 14B shows a balloon with balloon restrictions 674 involving portions of the length of the balloon. Balloon restrictions 674 can be attached to the outside of the balloon. Restrictions 674 can be attached or tied around the balloon. Balloon constraints 674 can serve to narrow and group the balloon at the point where they are applied, thereby creating a balloon flexing section 670. A balloon flexing section 670 may also be created by reweaving the balloon.
[00171] Figures 15 and 16 show a balloon 650 after balloon segments 656 have been formed into an annular balloon structure 682 and inflated. The balloon segments can form a ring with a clear, hollow passageway or channel in the center. The working length of the annular balloon structure 680 can be about or equal to the longitudinal length of the largest section of constant diameter of each segment of balloon 656. The working length 680 can be about 12 mm to about 100 mm, more strictly about 25mm to about 75mm, even more strictly 32mm to 65mm. The working length 680 can be about 45 mm. The balloon segments 656 can be coupled together with adhesive, solvent, an application of heat or combinations thereof. Figure 15 shows that the local flexion balloon diameter of the flexed or relaxed (ie, non-flexed) section 670 can be less than the main balloon diameter of the balloon segments 656. Figure 16 shows a flexion section 670 where the balloon was flexed or folded without the previous narrowing of the balloon diameter. The balloon can be inflated by putting pressure on the inflation / deflation holes of balloon 654a and 654b. Inflation / deflation ports 654a and 654b can be connected to a single inflation / deflation port.
[00172] The first segment of balloon 656a may have a first longitudinal axis of balloon segment 657a. The second segment of balloon 656b may have a second longitudinal axis of balloon segment 657b. The angle of the longitudinal axis of the balloon segment 659 can be the angle between the first longitudinal axis of the balloon 657a and the second longitudinal axis of the balloon segment 657b. The angle of the longitudinal axis of the 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 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.
[00173] Figure 17 shows a group of 650 inflated balloons arranged in a 682 annular balloon structure. Instead of sharing an inflation / deflation lumen, each balloon has two inflation / deflation holes 654. Figure 18 shows a balloon design with an inflation / deflation hole and the other end closed. The balloon in 8B may be arranged in an annular balloon structure 682 similar to that shown in Figures 15, 16 and 17. Balloons 650 can have their inner volumes connected together by drilling or puncturing holes in the wall of each balloon and then aligning the holes in each balloon before connecting the 650 balloons together.
[00174] Figure 19 shows a method of forming balloon 650 in an annulus. The adhesive 208 or a solvent can be applied to the outside of the flask. The balloon 650 can be screwed around pins 676. The balloon flexing section 670 can be interlaced approximately from the longitudinal axis of the balloon, for example, 45 or 90 degrees. A compression fitting, for example, an 898 balloon fitting fitting compression sleeve (for example, a non-stick tube such as one made of fluorinated ethylene propylene (FEP), such as Teflon) can be slid over the balloon 650 in order to hold and radially compress the balloon segments 656 together. The compression sleeve of the balloon assembly accessory 898 may have an inner diameter smaller than the outer diameter of the annular balloon structure 682 shown in, for example, Figures 15, 16 or 17. A cross-section of the balloon 650 in the sleeve Compression of balloon assembly accessory 898 may appear similar to Figure 24B with housing 678 being replaced by the compression sleeve of balloon assembly accessory 898. Heat can be applied to cure adhesive 208 or to fuse or condense segments 656 together.
[00175] Figure 20A shows a balloon 650 after having been formed into a spiral to make an inflated annular balloon structure 682. That is, balloon 650 forms a spiral ring with a central fluid passage 692 in the center. The coil spirals can be coupled to each other with adhesive, solvent, the application of heat or combinations thereof. The balloon can be inflated by putting pressure on the inflation / deflation holes of the 654 balloon. Multiple spiral coils can be interleaved to form an annular balloon structure.
[00176] Figures 20B and 20C show a spiral forming tool 742. The spiral forming tool has a spiral groove 746. A nominally linear balloon 650 can be wrapped around the spiral groove and pressurized. The pressurized assembly can be placed in the oven. The dimensions of the balloon may gradually deform until the balloon has been formed in the spiral shown in 11a.
[00177] Figure 21 shows that balloons 650 can have toroidal configurations. Balloons 650 can be stacked to make an annular balloon structure 682. Balloons 650 can form a ring with a clear passageway in the center. The balloons 650 can be coupled to each other with adhesive, solvent, the application of heat or combinations thereof. Balloons 650 can be inflated by placing pressure on the inflation / deflation orifice of balloon 654 (not shown). The lumens of each balloon 650 can be in fluid communication with one or more (for example, all) the other lumens and connected to one or more (for example, all) of the other lumens internally.
[00178] Figures 22A and 22B show that the balloon 650 can be coupled to a balloon strap 672. The balloon 650 can be in a spiral configuration. The balloon strap 672 can be removed during a medical procedure in such a way that the balloon 650 can unwind along the first hollow rod 2000a. This can make it easier to extract the balloon 650 through an insertion after a procedure.
[00179] An annular balloon structure may comprise a balloon 650 and a shell 678.
[00180] Figure 23A shows that the inflated annular balloon structure may have an envelope 678. The envelope 678 may envelop, surround or surround the segments of the balloon 656. The envelope 678 may entirely or partially (as shown) cover the segments of the balloon 656.
[00181] 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 enable the annular balloon structure 682 to spill when used in a lumen in the body. The annular balloon structure 682 may have an inner radius 690. That inner radius 690 may 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 may 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.
[00182] Figures 23B and 24B reveal 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 can have an internal radius of contact of balloon 694 and another radius of contact of balloon 698. These radii are aligned with the deepest 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 tangency tip. The inner radius and the outer radius of contact of the balloon can be about 3.8 mm to about 15 mm, more strictly about 7.5 mm to about 11.5 mm. The internal radius and the external contact radius can be about 9.5.
[00183] The radius of the balloon 704 can be the radius of the circle crossing all the axes of the center of each balloon cell 691. The radius of the balloon 704 can be about 5 mm to about 15 mm, more strictly about 5 mm about 13 mm. The radius of the balloon 704 can be about 10 mm. The wall of the casing 684 may have an average thickness of the casing 686 of about 7 pm to about 65 pm, more strictly about 13 pm to about 38 pm, even more strictly about 20 pm to about 30 pm. The outer river of the enclosure 708 may be the radius inside the enclosure 706 plus the thickness of the enclosure. The outer radius of enclosure 708 can be equal to one half of the outer diameter of the central section of enclosure 50.
[00184] The radius of balloon 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 radius of the balloon 702 can be about 3.8 mm.
[00185] Balloon cells 691 may have about zero contact with each other and with the interior of housing 678 (as shown in Figure 23B on the contact line of housing 712). The leakage area 700 between the inner wall of the casing and the contacts of the balloon 710 can be 12-22% of the total area involved by the cross-section of the casing, more strictly about 17%. The leakage area can be greater than 10%, more strictly greater than 15%.
[00186] Figure 24A shows an inflated annular balloon structure 682 with an envelope 678. The envelope 678 can entirely or partially (as shown) cover the segments of balloon 656. Balloon 650 shown in Figure 24A may have similar or identical dimensions to the balloon 650 shown in Figure 23A. The housing 678 shown in Figure 24A may have a smaller outer radius of the housing 708 than the housing 678 shown in Figure 23A. The wrapper 678 in Figure 24A can be placed over the segments of the balloon 656. The wrapper can compress or squeeze segments of the balloon 656 in such a way that the segments of the balloon 656 can be deformed and directed closer to the longitudinal axis of the wrapper 26. Housing 678 may be in tension when balloon segments 656 are inflated.
[00187] 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 the openings 714 in proximal tapering 34 and distal tapering 42. When the annular balloon structure 682 is placed in a lumen of the body, for example, in the vasculature, fluid (such as blood) or gas (such as air) in the lumen can flow through the passage central fluid 692. For example, the balloon can inflate when in the vasculature or in the airways.
[00188] The annular balloon structure may have a second hollow stem 2000b in the central fluid passage 692. It may be a gap of flow area 693 between the second hollow stem 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 rod 2000b is not shown in Figures 23A, 23B and 24A.
[00189] The internal radius 690 of the 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.
[00190] Balloon cells 691 a and 691 b can be joined by the contact line of balloon 710, for example, with a connection. The annular balloon structure 682 can have an internal radius of balloon contact 694 and an external radius of balloon contact 698. These radii are aligned with the deepest and outermost extension of contact of balloon 710 between balloon cells 691a and 691b . The internal contact radius of the balloon 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 contact radius of the balloon can be about 6.4 mm. The external contact radius of the balloon 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 contact of the balloon can be about 10 mm. The contact line of balloon 710 can have a contact length of about equal to the inner radius minus the outer radius
[00191] The perimeter of balloon cell 696 is about equal to the total length of dotted line 696 shown in Figures 23B and 24B (the dotted line matches the wall of balloon cell 691). Balloon cells 691 can have a balloon 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.
[00192] The length of the 710 balloon contact line may be greater than about 5% of the perimeter of the 696 balloon cell, more strictly greater than about 10%, even more strictly greater than about 12%, for example. example about 16%.
[00193] The outer radius of the balloon 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 the 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.
[00194] The leakage area 700 between the inner wall of the casing 678 and the contact line of the balloon 710 can be less than about 15% of the total area involved by the cross section of the casing, more strictly less than about 10 %, even more strictly less than about 5%, for example 2%.
[00195] The leakage area 700 can be sealed (without fluid communication) from the passage of central fluid 692. The leakage area 700 can be connected to a pressure source accessible by the doctor. Leakage area 700 may contain a fluid, for example, a drug. The wall of the enclosure 684 may have pores, for example, holes less than 0.005 mm in diameter. The wall of the casing 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 pass from the inner casing 47 to the outer casing 49.
[00196] The length of the arc of the contact line of the housing 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.
[00197] Figure 24b reveals that the balloon cells 691 in the contact line of the housing 712 may be concentric with the housing 678, for example, with the inner perimeter of the housing. The cell wall length of balloon 691 in the contact line of housing 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 than about 20% of the perimeter cells of the 696 balloon (i.e., the total length of the balloon cell wall in the side section, that is, the section shown in Figure 24b).
[00198] The internal perimeter of the enclosure in a plane can be about or equal to the radius inside the enclosure 706 multiplied by 2 multiplied by pi. The sum of the arc lengths of all contact lines of enclosure 712 on a plane in the annular balloon structure 682 can be greater than 30% of the inner perimeter of the enclosure, more strictly greater than 45%, even more strictly greater than that 55%, for example, 61%.
[00199] A connection can be formed between the segment of the balloon 656 and the envelope 678 in the contact line of the envelope 712 with adhesive, solvent, heat or combinations thereof. Housing 678 may have adhesive 208 on the surface within the housing, for example, a thermoplastic or thermoset.
[00200] The length of the arc of the contact line of housing 712 may be greater than 10% of the perimeter of the 696 balloon cell, more strictly greater than 15%, even more strictly greater than 20%, for example, 24 %.
[00201] Figure 25a shows an inflated spiral balloon 650 (as shown in Figure 20a) with a wrapper 678. Wrapper 678 can wrap, tie or include balloon 650. Wrapper 678 can fully or partially (as shown) balloon 650. Figure 25b shows a longitudinal cross section HH of the annular balloon structure 682 shown in Figure 25A.
[00202] Figure 26a shows an inflated spiral balloon with a wrapper 678. The balloon 650 shown in Figure 26A can have similar or identical dimensions to the balloon 650 shown in Figure 25A. Housing 678 shown in Figure 26A may have an outer radius of housing 708 less than housing 678 shown in Figure 25A. Housing 678 in Figure 26A can be placed over balloon 650. Housing can compress or squeeze balloon 650 in such a way that balloon 650 can be deformed and directed closer to the longitudinal axis of housing 26. Housing 678 can be in tension when balloon 650 is inflated. Figure 17b shows a longitudinal cross-section of a spiral balloon with a housing 678. The contact line of housing 712 can be oriented in the longitudinal direction. The leakage area of the housing can be formed as a spiral.
[00203] Figures 27A and 27B reveal that housing 678 may have a balloon 650 inside housing 47. The mainstay of Housing 716 may contain additional elements not included in the central section of housing 38. For example, the mainstay of housing 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 shell taper reinforcements. The polymer film may have a low coefficient of friction on the outermost surface, for example, it can have a coefficient of friction of less than 0.25, more strictly less than 0.15, even more strictly less than 0.1. Proximal taper 34 and distal taper 42 can help to introduce and remove the annular balloon structure 682 through a standard vascular introducer. For example, the tapers 34 and 42 can protect the balloon 650 from being damaged by friction in the vascular introducer or features, such as calcifications, in the body. The tapers 34 and 42 can guide the annular balloon structure 682 through the introducer.
[00204] Figure 27B shows the K-K cross section of the inflated annular balloon structure 682. Figure 27D shows a close view of a portion of Figure 27B. Balloon segments 656 can be compressed by housing 678. The annular balloon structure 682 can have a second hollow stem 2000b, a third hollow stem 2000c and a fourth hollow stem 2000d. As shown in Figures 27B and 27D, the fourth hollow stem 2000d can engage the outer parts of the stems 2000b and 2000c to make the stems 2000b and 2000c approximately coax. Rods 2000b and 2000c can slide in on the inside of rod diameter 2000d. Rods 2000b and 2000c may be in fluid communication. The gap of a hollow stem 2002 is formed between the distal end of the stem 2000b and the proximal end of the stem 2000c.
[00205] Figure 27C shows Figure 27B with 682 annular balloon structure in a reduced state. Figure 27E shows a close-up view of a portion of Figure 27C. Figure 27E shows that the rods 2000b and 2000c move within the inner diameter of the rod 2000d when the annular balloon structure 682 is reduced. The hollow shaft gap 2002 increases when the annular balloon structure 682 moves from an inflated to a reduced state. The second hollow rod 2000b, the third hollow rod 2000c and the fourth hollow rod 2000d can form an internal lumen 154a. The inner lumen 154a can extend through the center of the annular balloon structure 682. A guide wire can be inserted into the inner lumen 154a to locate the balloon during a medical procedure. The third hollow rod 2000c and the fourth hollow rod 2000d can be omitted and the second hollow rod 2000b can be extended to the tip of the catheter 838.
[00206] The first hollow rod 2000a can be in fluid communication with the distal hollow rod orifice 54 and the inflation / deflation holes of balloon 654. The addition of fluid or gas in holes 654 can cause the segments of balloon 656 to inflate and for the 682 annular balloon structure to expand. Removing fluid or gas from orifices 654 can cause balloon segments 656 to shrink and for annular balloon structure 682 to return to the folded state, for example, as shown in Figure 7C.
[00207] Figure 28A shows the K-K cross section of an inflated annular balloon structure 682. Figure 28C shows a close up view of a portion of Figure 28A. The annular balloon structure may have a second hollow stem 2000b that slidably dumps at the tip of catheter 838. A gap of hollow stem 2002 is formed between the distal end of stem 2000b and the bottom of the catheter tip pocket 840. The tip of catheter 838 can have a catheter tip outlet 841. Fluid flow 870 (shown with a dotted line in Figure 28A) can pass through openings of housing 714 in distal taper 42 or proximal taper 34 in the central fluid passage 692 and through openings of housing 714 in the proximal tapering 34 or distal tapering 42.
[00208] Figure 28B shows Figure 27A with the annular balloon structure 682 in a reduced state. Figure 28D shows a close-up view of a portion of Figure 28B. Figure 28D shows that the stem 2000b moves inside the tip of the catheter 838 when the annular balloon structure 682 is reduced. The gap of the hollow shaft 2002 increases when the annular balloon structure 682 moves from an inflated to a reduced state. The second hollow rod 2000b can form an internal lumen 154a. The internal lumen 154a can be in fluid communication with the outlet of the catheter tip 841.
[00209] Figure 28A shows that the balloon push-up section 670 can be within the volume contained by the central section of the casing 38 with the central length 40. Figure 27B shows that the balloon push-up section 670 can touch the wall of the wrapper 684 in conic sections 42 and 34.
[00210] Figures 29 and 30 show that the annular balloon structure 682 can have 2,3,4,5,6,7,8 or more support members 722 and / or support sheets 726. Support members 722 and / or support sheets 726 can pass through the central fluid passage 692. Support members 722 and / or sheets 726 can be firmly attached to the segments of balloon 656 and / or second hollow rod 2000b. 726 sheets can be beveled or forked so that they can pass through each other. The support members 722 and / or sheets 726 can be constructed similarly similar to the wall of the enclosure 684 and can be substantially incompatible. Support members 722 and / or sheets 726 can be semi-compatible, compatible or highly compatible. Support members 722 and / or sheets 726 can be made of an elastomer such as urethane. Support members 722 and / or sheets 726 may comprise a fiber. Support members 722 and / or sheets 726 may have a failure strength of less than about 10%. Support members 722 and / or leaves 726 may be in tension when the annular balloon structure 682 is inflated and serves to control the maximum diameter of the annular balloon structure 682 when inflated. When pressure is removed from the annular balloon structure 682, support members 722 and / or sheets 726 can help to collapse structure 682 in a way that helps folds or streaks to reform. The reforming of folds or grooves can make it easier for the collapsed balloon to be removed through the lumen of the bodies, for example, through the vasculature and through an intubator.
[00211] 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 firmly attached to segments of balloon 656 or within the wall of housing 684. Valve leaflets can be thin and flexible. The valve leaflets can contact the outside of the second hollow stem 2000b when in a relaxed state.
[00212] With reference to Figure 31 A, the central fluid passage 692 can be filled with a liquid or a gas. When the pressure in the liquid or gas is greater at distal tapering 42 than at proximal tapering 34, valve leaflets 734 can open (as shown in Figures 31A and 31C) to allow fluid to flow 870 through the central fluid passage. When the pressure difference in liquid or gas between distal bottleneck 42 and proximal bottleneck 34 is reduced or removed, valve 734 leaflets can close and reduce or eliminate fluid flow in the central fluid passage 692. Valve leaflets 734 can act as a one-way valve. A difference pressure in the liquid or gas between the distal taper 42 pressure and the proximal taper 34 can be generated by a heartbeat during a medical procedure. Valve 734 booklets 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 similar to the wall of the 684 housing or be made of a highly compatible material such as, for example, an elastomer.
[00213] The exterior of the wall of casing 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 can be a film soaked in a drug, a film with pores to hold the drugs, a fiber matrix holding the drugs or combinations thereof. Layer 72 can be an outer layer 72a, an inner layer 72b or a middle layer, such as 72c.
[00214] 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 a diameter within the capsule 890.
[00215] 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.
[00216] The length of the capsule 878 divided by the diameter of the capsule 882 can form a capsule length for proportional width. The capsule length for the width ratio 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 waist diameter of the capsule 886 can be less than about 90% of the diameter of the capsule 882, more strictly less than about 80% of the diameter of the capsule 882, even more strictly less than about 70% of the diameter of the capsule. 882 capsule.
[00217] Figure 33A shows a capsule 874 with the conical section of capsule 894 and orifice for inflating the capsule 896. Providing material, such as a liquid or a gas, in the inflating orifice the capsule 896 can cause the capsule 874 to inflate. By suppressing material in the inflating orifice the capsule 896 can cause the capsule 874 to deflate.
[00218] Figure 33B shows that a first capsule 874a and a second capsule 874b can be aligned concentrically and in contact to form an annular balloon structure 682 with an hourglass shape. The first capsule 874a can be inflated or reduced in the first inflation port 896a. The second capsule 874b can be inflated or reduced in the second inflation port 896b. The internal lumens of 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.
[00219] Figure 34 shows an 874 capsule in a pleated condition. Capsule 874 may have a distal taper 42 with a distal taper length 44 of about 0 mm.
[00220] The wall of the capsule 876 may comprise a fiber matrix, a layer 72 or 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 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 an incompatible capsule diameter 882 when inflated.
[00221] Figure 36 reveals that housing 678 can be partially or completely prepared in a pressure chamber 219. Pressure chamber 219 can be in a pressure chamber housing 218. Pressure chamber housing 218 may have a top housing 220a separable from housing bottom 220b. The top of the housing 220a can have a housing top hole 222. The bottom of the housing 220b can have a housing bottom hole 224. The top hole of the housing 222 can be in fluid communication with the top of the pressure chamber 219. The bottom orifice of the housing 224 may be in fluid communication with the bottom of the pressure chamber 219.
[00222] The top of the housing can screw or otherwise tighten if it joins the bottom of the housing. The pressure chamber housing may have one or more o-rings (not shown) on o-226 ring seats.
[00223] The pressure chamber may have a mandrel seat 228. Mandrel seat 228 may be configured to receive a mandrel 230. Mandrel seat 228 may have holes and pores. The holes or pores in the chuck seat 228 may allow pressure from the bottom hole of the housing and the bottom of the pressure chamber to reach the top surface of the chuck seat around the chuck and / or directly under the chuck.
[00224] Mandrel 230 may have the internal dimensions of housing 678.
[00225] The mandrel 230 can be made of a low melting wax or metal, a foam, some collapsing structure or an inflatable blade. The mandrel 230 can be made of a maintenance-free or non-maintenance bismuth alloy and removed by raising the temperature to the melting point of the metal. Chuck 230 may be a water-soluble chuck. Chuck 230 can be made of aluminum, glass, sugar, salt, corn syrup, hydroxypropylcellulose, amber gum, polyvinyl alcohol (PVA, PVAL or PVOH), hydroxypropyl methyl cellulose, polyglycolic acid, a ceramic powder, wax, gelatin ballistic, polylactic acid, polycaprolactone or combinations thereof.
[00226] A panel 196a can be positioned on mandrel 230. Panel 196a can have a single layer or multiple layers. For example, panel 196a may be a layer of adhesive film that can be melted 208. Panel 196a can be positioned with film on the side that touches the mandrel and adhesive on the outside radially.
[00227] Figure 37A illustrates that a positive pressure can be applied to the top 220a of the pressure chamber (for example, through the top housing of the 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 bottom hole of the housing 224). Panel 196A can be sucked and / or pressed down and / or formed over mandrel 230. The first panel 196A can be smoothly inserted into mandrel 230 and adhered to the mandrel in the first adhesive 208A. The first panel 196A can stretch and / or render and / or deform. The first panel 196A may become thinner after being stretched, rendered or formed. 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 forming on mandrel 230. Formation 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.
[00228] The formation of panel 196a can also be carried out with a mechanical matrix. The mechanical matrix can be heated and shaped close to the shape of the mandrel 230. The mechanical matrix can be similar in shape to the mandrel seat 228.
[00229] Mandrel 230 and panel 196a can be mounted in a trim pattern. Any exception portion of the first panel 196a extending from mandrel 230 can be trimmed with a blade, with a laser, with a waterjet cutter, with a die cutting tool or combinations thereof. The trimming pattern can cover mandrel 230 and the first panel 196a coupled to mandrel. Several panels 196a and / or layers 72 can be formed on mandrel 230 and cut. Panels 196a and / or layers 72 can be trimmed at the same time or one at a time.
[00230] Figure 37B reveals that the mandrel may have excess area of the first panel 196A removed in preparation for coupling the second panel 196b.
[00231] 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 in a chuck seat.
[00232] Figure 37C reveals that after the top of the housing 220a is attached to the bottom of the housing 220b, positive and / or negative pressures can be applied to the pressure chamber as described below. The second panel 196b can be lightly filled or formed by pressing to or against the mandrel 230 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 blade 52 of the wall of the enclosure 684. The inner layer can be watertight. The inner layer may be able to sustain the 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 and to decrease the module of the panels 196.
[00233] Figure 37D shows the cross-section L-L with the mandrel 230 omitted. The ampoule 52 may have a first inner seam 69a, a second inner seam 69b first inner layer panel 74a, second inner layer panel 74b and inner layer 72b. The ampoule 52 can be watertight.
[00234] Figure 38A shows the ampoule 52 after fitting into a mandrel 230 (mandrel 230 is inside the ampoule 52 and not directly shown in Figure 38A). The bulb 52 may be slightly larger in diameter and / or longer in length than the mandrel 230 on which the bulb 52 is fitted. This can allow the ampoule 52 to be reassembled in the mandrel 230 with an internal seam 66 that can be sealed. Figure 38A shows a longitudinal seam 66 running the length of the ampoule 52. The seam 66 can be sealed with adhesive, by melting, by heating, with a solvent or combinations thereof. The sealed ampoule 52 can form the inner layer 72b of a housing 678 and be watertight. The seam 66 can be an outer seam 66a or inner seam 66b.
[00235] Figure 38B reveals that the first portion of the ampoule 52a can overlap on an overlapping or overlapping joint (as shown), confined to a boundary, or flange with the second portion of the ampoule 52b at seam 66. Seam 66 can be angled, vertical or spiral or combinations thereof.
[00236] Figure 39A shows a cross section of a trailer 270. Trailer 270 can contain about 6, 25, 100, 500 or 1500 monofilaments. Trailer 270 can have a trailer height 271 and a trailer width 272.0 trailer 270 can be approximately circular. For example, the height of the trailer 271 and the width of the trailer 272 may be about 0.025 mm (0.001 in) to about 0.150 mm (0.006 in), more strictly about 0.050 mm (0.020 in) to about 0.100 mm ( 0.040 in), even more strictly about 0.075 mm (0.003 in). Trailer 270 can be loosely held together by a polymer finish (not shown).
[00237] Figure 39B shows that trailer 270 can contain a marker wire 190. Marker wire 190 can be circular, as shown, and radiopaque.
[00238] Figure 39C shows trailer 270 after trailer 270 has been expanded. Trailer 270 can be leveled or expanded by passing trailer 270 through a set of approximately spaced rollers that form a tight narrow gap. Trailer 270 can be expanded by pulling trailer 270 under tension over a set of rollers or pins. After expanding, trailer 270 may have a trailer height 271 that is less than about twice the height of fiber 1068, for example, about the same as the height of fiber 1068. The height of fiber 1068 and the width of fiber 1072 can be substantially immutable after expanding. For example, the width of fiber 1072 and the height of fiber 1068 can be about 15 pm (0.0006 in), the width of trailer 272 can be about 210 pm (0.008 in) and the height of trailer 271 can be about 15 pm (0.0006 in). Marker wire 190 is not shown in Figure 39C, but may be present after trailer 270 has been expanded.
[00239] Figure 40A reveals that a fiber matrix layer can be made on a roll 232. Roll 232 can be configured to rotate about a roll axis 234. Roll 232 can have a diameter of about 100 mm at about 1,000 mm. The roll 232 can be made or coated with an anti-stick material such as a fluoropolymer.
[00240] Figure 40B reveals that a release 236, such as a release layer, can be placed around the circumference of the roll 232. The release layer can be a friction film or coating. The release layer can be a thin and / or flexible fluoropolymer sheet.
[00241] Figure 40C shows that an adhesive 208 can be placed on the release or directly on roll 232 (for example, if no release is used 236). Adhesive 208 can be a thermoplastic film. Adhesive 208 may be a thermoset adhesive. Adhesive 208 can be a thermoplastic or solvated thermoset. Adhesive 208 may have a protective film, such as paper.
[00242] Figure 40D shows the application of reinforcement fiber 86 to roll 232. Fiber 86 can be unwound from a spool (not shown) and wound over the top surface of adhesive 208. Winding up first, 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 previously been leveled as detailed above. The fiber86 may have a non-circular cross-section, such as a rectangle or an ellipse. Any coating or bonding on the fiber may have been removed using a solvent. The fiber 86 can be laid with an interval between each successive fiber fold. The range can be less than about 200 pm (0.008 in), more strictly less than about 5 pm (0.0002 in). A heat source or solvent can be used to fix fiber 86 to adhesive 208 (i.e., nail fiber 86 in place over adhesive 208), to melt or solvate a material over release layer 236, to melt or solvate a material on fiber 86 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 spun up to 3000 to 30 times per 1 inch (25.4 mm). The peak can be chosen based on the total size of fiber 86 or trailer 270 being applied and the interval chosen between each subsequent fiber 86 or trailer 270 on roll 232. Applications of a single monofilament 274, which may be a yarn, may have peaks from about 2000 to about 100 times per 1 inch (25.4 mm).
[00243] 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.
[00244] Figure 40F reveals that the roller can be placed between a vacuum top sheet 238a and a vacuum bottom sheet 238b, for example, in a vacuum bag. A vacuum seal tape 240 can surround the roller 232 between the bottom of the vacuum and the top sheets 238b and 238a, respectively. Air can be removed from between the vacuum top and bottom sheets 238a and 238b and inside the vacuum seal tape, for example, by suction from a suction tube 242. Inside and / or outside the vacuum bag, roller 232 can be heated, for example, to melt or cure adhesive 208. Roller 234 can be removed from the vacuum bag, for example, after melting or curing of the adhesive is complete.
[00245] 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.
[00246] Figure 40H reveals that the fiber matrix panel 196 can be removed from roll 232. For example, panel 196 can be detached from release 236. Panel 196 can be repositioned on roll 232 at about 90 degrees to the anterior layer angle 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 "0-90" layer, so called the two layers of fiber made with respect to each other for the angle). Panel 196 can be cut into a smaller panel. For example, panel 196 can be cut with a trimming pattern, a laser, a waterjet cutter, a die cutting tool, or a combination thereof.
[00247] Figure 41A shows that a panel 196 can have reinforcement fibers 86b oriented substantially parallel to the longitudinal edge of the panel 332. The panel 196 can have a panel width 334. The panel width 334 can be about or equal to the circumference of enclosure 678 in central section 38. Panel 196 may have a length of panel 335. The length of panel 335 may be greater than the length of enclosure 28. Panel 196 may be a rectangular section of panel 336 and one or more panel sawmills 338a, 338b and 338c. Each panel saw 338a, 338b and 338c can have a portion of panel 186 that forms a trunk portion 30 or 43 and taper 34 or 44. Each sawmill 338a, 338b and 338c can have a saw edge 339a, 339b and 339c, respectively . The angle between the sawing edges 339 and a line parallel to the reinforcement fibers 86b can be a panel sawing angle 340. The panel sawing angle 340 can be about 30 °, about 20 °, about 10 ° , or about 0o. A first panel saw 338a can be substantially in line with a second panel saw 338b. One or more fibers 86b can run from the end end of the first sawmill 338a to an end end of the second sawmill 338b.
[00248] Figure 41B reveals that the longitudinal reinforcement fiber 86b can be parallel to the longitudinal edge 332. The second longitudinal reinforcement fiber 87b can be parallel to the fiber 86b. Fibers 86b and 87b can be separated by fiber separation areas 614. Fiber separation areas 614 can separate fibers 86b and 87b by about 2 mm, more strictly less than about 1 mm, even more strictly less than 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 fibers from beginning to end along the rectangular section of the panel in the direction of X. Housing 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 length of wrapper 28 more strictly less than about 75% as long, more strictly less than about 70% as long, even more strictly less than about 65% so long, even less strictly less than about 60% so long.
[00249] 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 sawmill 338b can be oriented in the Y direction substantially halfway between panel saws 338a and 338c. Panel sawing 338b can be oriented in the Y direction substantially closer to any of panel saws 338a or 338c. The longest length of reinforcement fiber 88 in panel 196 can be less than about 75% of the length 28 of the enclosure, more strictly less than about 70%.
[00250] Figure 42A shows that panel 196 can contain reinforcement fibers 85a and 85b arranged in an interlaced pattern. An interlaced pattern can have fibers 85a and 85b that alternatively pass over and under each other.
[00251] Figure 42B shows that panel 196 can contain reinforcement fibers 85 in a braided configuration.
[00252] Figure 42C shows that panel 196 may contain reinforcement fibers 85 of various lengths in random orientations, sometimes referred to as cuts or cutter fiber.
[00253] Figures 43A and 43B reveal 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 by applying adhesive either by heat or by combinations thereof. Panel 196, when folded into the shape of mandrel 230 can give substantially complete coverage of mandrel 230 with minimal or no overlap of panel 196. The rectangular section of panel 336 can cover the central section of housing 38. Panel saws 338 can cover proximal tapering 34, distal tapering 42, proximal trunk 30 and distal trunk 43.
[00254] A matrix can be used to press panel 196 onto housing 678. The matrix can be heated and panel 196 can contain a thermoplastic. The die can fuse the thermoplastic and adhere panel 196 to housing 678. The die can be formed to match the shape of mandrel 230. Then couple two sawmills 338 (one saw at each end of mandrel 230. See Figure 43A), mandrel 230 it can be rotated about its longitudinal axis to advance the next set of sawmills 338 in place under the die. The die can again press two sawmills 338 in place over housing 678. Subsequent use of the die in this way can substantially couple the entire panel 196 to housing 678 as shown in Figure 43B.
[00255] Figure 44 reveals that fiber 86 can be wound over mandrel 230 or over envelope 678. Fiber 86 can be continuous or batch. The mandrel can be rotated, as shown by arrow 252, about 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 rotated, as shown by arrow 254, unfolding fiber 86 (shown) or trailer 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 end fiber can attach to housing 678 or directly to mandrel 230.
[00256] The fiber 86a can be wound with an interval between each successive fiber winding. The range can be less than about 200 pm (0.008 in), more strictly less than about 5 pm (0.0002 in).
[00257] Fiber 86 can be wound with a peak of about 3000 to about 30 windings per 1 inch (25.4 mm). The peak can be chosen based on the total size of fiber 86 or trailer 270 being applied to the part of the first spool 244a and the interval chosen between each subsequent fiber 86 or trailer 270 in the part. Applications of a single 274 monofilament, which may be a yarn, may have peaks of about 2000 at about 100 turns per 1 inch (25.4 mm).
[00258] A tool arm 246 can be coupled by rotating tool wheel 248. Tool arm 246 can rotate and translate, as shown by arrows 256 and 258, to position the normal tool wheel 248 to and in contact with the housing 678. A second tool wheel 248 '(coupled to tool arm 246') may have a range of motion sufficient to apply normal pressure to the surface of a section of a housing taper.
[00259] Tool wheel 248 can press fiber 86 or trailer 270 against housing 678 and expand monofilaments 274. Tool wheel 248 can help adhere trailer 270 to the housing, for example, by applying pressure and following closely the casing surface. The tool wheel 248 can be heated to soften or melt the material on the surface of shell 678. Another source of heat or a solvent can be used to hold the fiber in place, to melt or solvate a material in the shell, 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 welding machine can be used with or without the 248 tool wheel to couple 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 or coated with a non-rod material. Tool wheel 248 may not rotate. The tool wheel 248 may comprise a hard surface, for example, carbide.
[00260] A second spool 244b can unfold the marker wire 190 during a winding operation. The second spool 244b can also wind a reinforcement fiber 85 (not shown). Marker wire 190 (or reinforcement fiber 85) can be applied simultaneously with fiber 86 and / or trailer 270 to the wrapper. Marker yarn 190 can interleave with reinforcement fiber 86 to form a single fiber layer in envelope 678. Marker yarn 190 can be deposited on top below another existing fiber layer.
[00261] The resulting layer deposited in Figure 44 can have a layer thickness 216 from about 1 pm (0.00004 in) to about 50 pm (0.002 in), more strictly from about 8 pm (0.0003 in) ) to about 25 pm (0.001 in).
[00262] The techniques described in Figures 36, 37A, 37B and 37C can be used to apply additional panels 196 or layers 72 to housing 678. For example, two panels 196 can be applied to form an outer layer 72a in housing 678 as shown in Figure 45A.
[00263] 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. Panels 196e and 196f may be like those shown in Figures 46A and 46B.
[00264] Figure 46A shows panel 196 with panel cut 842 and panel lobe 846. Panel cut 842 can be aligned in a housing 678 to form an opening 714. Panel lobe 846 can be placed in a housing 678 to form a shell reinforcement lobe 866.
[00265] Figure 46B shows a panel 196 with a panel cut 850. The panel cut 850 can enable the panel to form on the housing 678.
[00266] Figure 47 reveals that a washing tube 264 can be inserted into a washing hole in the mandrel 262. A dissolving or solvating fluid can be distributed through a washing tube and into the washing hole 262. The mandrel it can be removed by dispensing a solvent fluid 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 ampoule. 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 collapsing an internal structure.
[00267] Figure 48A reveals that the casing 678 can be placed in a casing mold 622 containing a casing pocket 624. Casing mold 622 can be porous in such a way that substantial amounts of gas can be attracted from the casing pocket 624 through the casing 622 mold wall and out into the surrounding atmosphere. Housing 678 can have a tube (not shown) placed in its internal volume that can extend to any end of housing 622. The tube can be thin and very flexible. The tube may be a silicon rubber.
[00268] A coating can be sprayed into the mold 622 which connects to the casing 678 during curing and forms an outer layer 72a in the casing 678.
[00269] Figure 48B reveals that the casing 622 mold can be closed around the casing 678. Pressure can be applied through the second casing fluid holes in such a way that the casing expands to contact the inside of the casing pocket. housing 624. Alternatively, the tube (not shown) extending to the end of the housing can be pressurized to force the housing to contact pocket 624.
[00270] Figure 48C shows Pressure P within the enclosure volume by pressing the enclosure wall 684 outward. Mold 622 can be placed in an oven and heated. Mold 622 can be prepared in heaters. The mold of housing 622 can be placed under vacuum or placed in a vacuum chamber during heating. The wrapper mold 622 may have a texture, such as a texture created by eroding or blowing sand or blowing up beads from the wrapper mold 622. The texture may impart a texture to the outer layer 72b of the wrapper.
[00271] Heating the enclosure under pressure can cause one or more layers 72 to fuse and / or spindle and / or bond with adjacent layers 72. Merging under pressure can remove voids in the enclosure wall. The inner and outer films may not fuse. Heating the housing under pressure can cause the walls of the 678 housing to fuse or laminate in a continuous structure. The outer layer of the casing 72a can be substantially softened by this process. The outer layer 72a of the housing can be permeable or perforated in such a way that gas or other material trapped in the wall of the housing 684 during manufacture can escape when the housing is heated under pressure.
[00272] The radius outside the enclosure 708 can be very accurate and repeatable. For example, at a given pressure, the radius outside 708 of a group of shells 678 can all be within about 2% (+/- 1%) of each other. For example, if the nominal dimension of the outer radio 708 of the enclosure is about 12 mm at about 60 psi (414 kPa), all enclosures can have an external 708 radius from about 11.88 mm to about 12.12 mm.
[00273] A 678 housing can be stapled to a pleating tool with two, three, four, five or more removable stapling blocks. Heating the staple blocks to around 80C and then pressing them against the 678 housing for about 1 minute causes the housing to become pleated or streaked. 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 keep the pleated or folded wrapper in its desired shape.
[00274] As shown in Figures 49A and 49B, a balloon 650 can be placed in an insertion tool 854. Before being placed in the 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.
[00275] Figure 49C shows that openings 714 can be cut in 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 casing 47. The insertion tool 854 can be inserted through the inner volume of the proximal trunk of the casing 30 or distal trunk of the casing 43 or any other hole in the 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 within housing 678. Adhesive 208 or a solvent or application of heat can connect balloon 650 to an inner wall of housing 678 forming the annular balloon structure 682.
[00276] Figure 50 illustrates a balloon catheter. The inflation fluid can be provided by disposable syringe 472 through Y- adjustment of catheter 634. The inflation fluid can flow between the inner wall of the first hollow rod 2000a and the outer wall of the second hollow rod 2000b. The inflation fluid can flow into the balloon 650 to inflate the annular balloon structure 682. A guide wire can be inserted into the guide wire hole 632 and passed through the interior of the second hollow rod 2000b.
[00277] Figure 51 illustrates a cross-section of an annular ball structure 682 in a substantially reduced and pleated or folded configuration. The annular balloon structure 682 is shown on a tube 428 with a diameter inside the tube 436 and a cross sectional area of the diameter inside the tube 434. The annular balloon structure 682 can be inserted into the 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.
[00278] The compression ratio of the 682 annular balloon structure can be from about 3: 1 to about 10: 1, more strictly from about 5: 1 to about 7: 1. The compression ratio can be the ratio of twice the outer radius of the envelope 708 of the substantially inflated annular balloon structure 682, and a diameter within the tube 436. For example, an annular balloon structure 682 with a radius outside the envelope 708 equal at about 12.2 mm it can be inserted into a tube 428 with a diameter inside the tube 436 of about 4.8 mm, more strictly about 4 mm, even more strictly about 3.6 mm.
[00279] The annular balloon structure 682 can have a packing density equal to or greater than about 40%, more strictly greater than or equal to about 55%, even more strictly equal to or greater than about 70%. The packing density can be the proportion of the percentage between the cross-sectional area of the walls of the annular balloon structure 682 and the cross-sectional area of the diameter inside the tube 434.
[00280] The proportions of packing density and compression for the annular balloon structure 682 may remain substantially constant and the strength of the wall of the annular balloon structure 682 may remain substantially constant, with constant insertions or withdrawals from tube 428 and / or inflations and deflations of the 682 annular balloon structure, for example, 10 or 20 or 40 insertions and suppressions or inflations and deflations.
[00281] The 682 annular balloon structure 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 or without any external suppression on the walls at about 1 atm of external pressure and about 20 ° C in temperature. The unsupported burst pressure can be from about 2 atm to about 20 atm, more strictly from about 3 atm to about 12 atm, even more strictly about 4 atm to about 8 atm, for example 5 atm, 6 atm or 7 atm.
[00282] The 682 annular balloon structure may be incompatible or inelastic. For example, the annular balloon structure 682 may have a failure voltage of less than about 0.30, more strictly less than about 0.20, even more strictly less than about 0.10, even more strictly less than about 0.05.
[00283] The failure voltage of the 682 annular balloon structure is the difference between the outer radius of the casing 708 when the balloon is inflated to 100% of the burst pressure and the external radius of the casing 708 when the balloon is inflated to 5% burst pressure (i.e., to expand from a reduced state without stretching the wall material) divided by the outer radius of enclosure 708 when the balloon is inflated to 100% burst pressure.
[00284] The 682 annular balloon structure can have a compatibility of less than about 2% per atmosphere, more strictly less than about 1% per atmosphere, even more strictly less than about 0.7% per atmosphere , even more strictly less than about 0.4% per atmosphere.
[00285] The annular balloon structure 682 can be inflated to pressure A and pressure B. Pressure B can be a higher pressure than pressure A. Pressures B and A can be positive pressures. Pressures B and A can be greater than 1 atm. The delta pressure can be pressure B minus pressure A. The delta radius can be the outer radius of enclosure 708 when an annular balloon structure 682 is inflated to pressure B minus the outer radius of enclosure 708 when the annular balloon structure 682 is inflated for pressure A. Compatibility can be delta radius divided by outer radius of enclosure 708 when annular balloon structure 682 is inflated to pressure B divided by Delta pressure.
[00286] A wrapper 678 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 can be placed at -20 degrees from the longitudinal axis of the enclosure. 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 wrapper 678 is tensioned by balloon 650, the angle between the fibers will gradually increase until the angle of layer 738 is about 70 degrees. This is the angle 738 at which the fibers balance the longitudinal loads and the arc in the wrapper. The fibers can change their angles to each other by tensing the adhesive. Housing 678 can rapidly expand to a first diameter where a layer angle 738 is, for example, about 40 degrees and then slowly expands in diameter 50 when the internal pressure in housing 678 of balloon 650 is increased. By choosing the initial diameter 50 and the layer angle 738, a housing 678 can be designed that allows a variety of diameters 50 to be realized.
[00287] Figure 52 shows a cross section of the heart 562. The heart 562 has an aorta 568, a left ventricle 570 and an aortic valve 564
[00288] Figure 53 is a graph that shows how the percentage of stenosis creates acceptable, difficult and critical flow conditions in both conditions of rest and tension in a patient. The acceptability of a stenotic condition should also vary as a function of the time spent on each condition.
[00289] Figures 54A and 54B reveal that the 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 annular balloon structure 682 can be in a reduced or pleated state when first placed in the aortic valve 564. The annular balloon structure 682 can be positioned to align along the longitudinal axis of the balloon with the leaflets of the aortic valve 566. A annular balloon structure 682 can also be rotated around a longitudinal axis of the balloon to align with aortic valve 564, for example, when cutting leaflets coupled to part 566 into a bicuspid aortic valve with a flange, a fan, a blade , other cutting elements described here, or combinations thereof. Fluid from flow 870 can leave the left ventricle 570 through the leaflets of aortic valve 566 and into the aorta 568. Fluid flow 870 can comprise blood flow.
[00290] Figure 54C shows the annular balloon structure 682 in an inflated configuration. The annular balloon structure 682 may be incompatible and open the aortic valve 564 to a precise dimension (for example, about 20 mm or about 24 mm). The annular balloon structure 682 can fixedly reconfigure and press the aortic valve 566 leaflets against the outer wall or annulus 582 of the aortic valve 564. The annular balloon structure 682 can radially expand the annulus of the aortic valve 582.
[00291] Fluid flow 870 can pass through the openings of housing 714 in distal funnel 42, in the passage of central fluid 692 and through the openings of housing 714 in proximal funnel 34 thereby allowing blood to perfuse while the balloon structure 692 it is inflated. The central fluid passage 692 may have a cross-sectional area of 0.3 to 1.2 square centimeters, more strictly 0.5 to 0.8 square centimeters.
[00292] When the annular balloon structure 682 is inflated, there may be a pressure differential between the left ventricle 570 and the aorta 568. For example, the pressure differential can be from about 5 mm Hg to about 50 mm Hg , more strictly from about 10 mm Hg to about 40 mm Hg, even more strictly, from about 10 mm Hg to about 25 mm Hg.
[00293] The perfusion may allow the physician to leave the balloon structure inflated in the aortic valve 564 for longer than would be allowed with a non-perfusing balloon while still avoiding significant injury to the patient or the patient's hemodynamics. Increasing the time of inflation may allow a more careful and accurate remodeling of the vasculature, such as that performed during a valvuloplasty or a PCTA procedure.
[00294] One or more segments 656 of balloon 650 may employ a compatible material. Raising and lowering the pressure on these 656 compatible segments can cause the segment volume to change. A change in the volume of segment 656 can 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 segments of the balloon 656 to adjust the range of the flow area 693. The compatible balloon segment 656 can be an additional balloon enclosed by the 678 housing with an inflating lumen separate from the one used to inflate the 650 balloon
[00295] The doctor can inflate the annular balloon structure 682 until the structure 682 makes contact with the aortic valve 564 or the leaflets of the valve 566 or other vascular structures. This contact with avasculature can be confirmed through the use of small tears of radiopaque contrast. Once the annular balloon structure 682 is in contact with the vasculature, the increase in pressure distributed to the annular balloon structure 682 can be used to make changes in the diameter outside the central section 50 of the annular balloon structure and thereby change the shape of the patient's vasculature. The change in the shape of the vasculature can be monitored by ultrasound, fluorscopy 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 strictly more than 30 seconds, even more strictly more than 60 seconds while not adversely affecting the patient's health.
[00296] The 562 heart may be allowed to beat at its normal pace during the procedure. The 562 heart may be forced to beat at a high rate during the procedure.
[00297] Figure 54D reveals that the annular balloon structure 682 can be reduced, contracted and removed from the aortic valve 566 leaflets.
[00298] Figure 54FE shows the leaflets of the 566 aortic valve with a larger opening than before the procedure.
[00299] Instead of using a guide wire, an IVUS or OCT system can be inserted in the inner lumen 154a. These systems may allow visualization of the aortic valve 564, for example, the positioning of the 566 valve leaflets at any point during the procedure detailed in Figures 54A-54F.
[00300] 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 a balloon valvuloplasty or aortic balloon valvuloplasty. This procedure can be described as predilation when it is used to prepare the aortic valve for implantation of a prophetic valve. This procedure can also be employed after a prophetic valve is in place in order to better seat the valve within the patient's anatomy. In this case, it is often referred to as "post-dilation".
[00301] Referring now to Figures 55A-55F, the annular balloon structure 682 can be used to deploy the prosthetic valve into, for example, aortic valve 564 near coronary ostia 583. A guide wire 572 can first be introduced through aorta 568 in left ventricle 570, as shown in Figure 55A. Then, as shown in Figure 55B, a balloon catheter carrying prosthetic heart valve 626, and reduced annular balloon structure 682 can be introduced through guide wire 572 into aortic valve 564. In Figure 55C, the balloon structure annular 682 is inflated to expand prosthetic heart valve 626 in aortic valve 564. While the annular balloon structure 682 is inflated, the flow of fluid (e.g., blood) 870 can pass through the openings of housing 714 in the distal taper 42 , in the passage of central fluid 692 and through openings of the housing 714 in the proximal tapering 34. In Figure 55D, the annular balloon structure 682 is reduced and separated from the valve prosthesis 626, leaving the valve prosthesis 626 implanted in the aortic valve 564 Figures 55E and 55F show the prosthesis closing (55E) and opening (55F) immediately after the annular balloon structure 682 is removed.
[00302] Figure 56A reveals that the annular balloon structure 682 can be positioned on a guide wire 572 or stylus in a lumen of the body 574 having a constriction 576 inside the wall of the lumen 578. A stylus can be more rigid than one guide wire.
[00303] Figure 56B reveals that the annular balloon structure 682 can be inflated and expanded. The annular balloon structure 682 can reshape the lumen of the body 574, pushing the constriction 576 radially out of the longitudinal axis of the housing 26. The annular balloon structure 682 can deploy a stent for the constriction 576. While the annular balloon structure 682 is inflated, the flow of fluid (e.g., blood) 870 can pass through the openings of the casing 714 in the proximal tapering 34, in the passage of central fluid 692 and through the openings of the casing 714 in the distal tapering 42.
[00304] Figure 56C reveals that the annular balloon structure 682 can be reduced, contracted and removed from the lumen of the body 574. The lumen of the body 574 can remain patent after the annular balloon structure 682 is removed, for example, by restoring flow of blood passed the past atherosclerotic length.
[00305] The lumen of the body 574 can be a vial or an airway. Constriction 576 can be an atherosclerotic plaque or a local narrowing of the body lumen 574
[00306] The annular balloon structure 682 can be implanted in the body semipermanently or permanently.
[00307] The annular balloon structure 682 can be used for kyphoplasty, angioplasty including CTO dilation, stent delivery, sinuplasty, airway dilation, valvuloplasty, drug delivery or other fluid via balloon, radiopaque marking, incision within a vessel (for example, to open or expand a vessel), brachyotherapy, intentionally obstructing a vessel, or combinations thereof. The 682 annular balloon structure can be used to deliver one or more stents and / or valves and / or embolism filters to coronary blood vessels (eg, arteries or veins), carotid artery, peripheral blood vessels, the GI tract, bile ducts, urinary tract, gynecological tract, and combinations thereof.
[00308] Reinforcement fibers 85, 86 and 87 can be identical to or different from each other.
[00309] Any elements described here in the singular can be pluralized (that is, anything described as "one" can be more than one), and elements in the plural can be used individually. Any species element of a genus element can have the characteristics or elements of any other elements of species of that genus. The term "comprises" is not intended to be limiting. The complete configurations, elements or sets and methods described above and their elements for carrying out the invention, and variations of aspects of the invention can be combined and modified with each other in any combination.

权利要求:
Claims (15)
[0001]
1. An apparatus with an inflatable structure characterized by the fact that it comprises: a housing (678) having a longitudinal housing axis (26), a central section (38) and a first neck section, in which the first neck section has a first end of the first neck and a second end of the first neck, and where the first end of the first neck has a diameter of the first end of the first neck, and the second end of the first neck has a diameter of the second end of the first neck , and where the diameter of the first end of the first neck is greater than the diameter of the second end of the first neck, and where the first end of the first neck is adjacent to the central section (38); a balloon (650) at least partially inside the housing (678), where the balloon (650) is attached to the housing (678); where the housing (678) has a central fluid passage (692) radially inside the balloon (650) with respect to the longitudinal axis of the housing (26), and where the first opening (714) of the housing (678) is in fluid communication with the central fluid passage; in which the balloon (650) has a first cell and a second cell in a single cross-section of the inflatable structure, and in which the balloon (650) has a surface area of the balloon (650) in the single cross-section, and in which at least 5% of the balloon surface area (650) is concentric with the shell (678).
[0002]
2. Apparatus according to claim 1, characterized by the fact that it still comprises: a first groove (84a) in the housing (678), in which the first groove (84a) has a first inner crease of the first groove, a second crease inner of the first groove, and a first outer crease of the groove between the first inner crease of the first groove and the second inner crease of the first groove; a first opening (714), wherein the first opening (714) is at least partially in the first stria (84a), and where the first opening (714) does not cross the first outer crease of the stria, where the adjacent walls of the first cell and the second cell have more than about 5% contact with each other; and that the first neck section has a first neck section stiffness, and that the center section (38) has a central section stiffness (38), and that the first neck section stiffness is greater than the center section stiffness (38).
[0003]
Apparatus according to claim 1, characterized by the fact that it still comprises a tube extending along the longitudinal axis of the housing (678), in which the central fluid passage is between the tube and the radius inside the balloon ( 650) with respect to the longitudinal axis of the housing (26), and in which the tube has a lumen.
[0004]
4. Apparatus according to claim 1, characterized in that the first neck section has an average wall thickness of the first neck section, and the central section (38) has an average central wall thickness , and where the average wall thickness of the first neck section is greater than the average wall thickness of the central section (38).
[0005]
5. Apparatus according to claim 2, characterized by the fact that the first groove (84a) is in the section of the first neck.
[0006]
6. Apparatus according to claim 1, characterized by the fact that at least 30% of the envelope perimeter (678) is concentric with the surface area of the balloon (650).
[0007]
7. Apparatus according to claim 1, characterized by the fact that the balloon (650) has a first cell and a second cell in a single cross-section of the inflatable structure, and in which at least 30% of the envelope perimeter (678 ) are in contact with the cells.
[0008]
8. Apparatus according to claim 1, characterized by the fact that the balloon (650) has a first cell and a second cell in a single cross section of the inflatable structure, and in which at least 5% of the balloon's surface area (650) are in contact with the housing (678).
[0009]
Apparatus according to claim 2, characterized by the fact that it still comprises a second groove, and in which the first opening (714) is covered by the second groove when the inflatable structure is in a reduced configuration.
[0010]
Apparatus according to claim 2, characterized by the fact that it still comprises a second opening (834) and a second groove, and in which the second groove comprises a first inner crease of the second groove, a second inner crease of the second groove , and an outer crease of the second groove between the first crease of the second groove and the second crease of the second groove, and in which the second opening (834) is at least partially in the second groove, and in which the second opening (834 ) does not cross the outer crease of the second groove.
[0011]
11. Apparatus according to claim 1, characterized by the fact that the housing (678) has a second neck section, and the second neck section has a first end of the second neck and a second end of the second neck, and where the first end of the second neck has a diameter of the first end of the second neck, and where the second end of the second neck has a diameter of the second end of the second neck, and where the diameter of the first end of the second neck is larger than the diameter of the second end of the second neck, and the first end of the second neck is adjacent to the central section (38).
[0012]
Apparatus according to claim 11, characterized by the fact that it still comprises a second opening (834) in the second neck section, and in which the first opening (714) and the second opening (834) are in fluid communication with the passage of central fluid.
[0013]
13. Apparatus according to claim 1, characterized by the fact that the central section (38) has a diameter of the central section, and in which the diameter of the central section is constant along the length of the central section.
[0014]
Apparatus according to claim 1, characterized by the fact that the balloon (650) is at least partially in the central section (38) of the housing (678).
[0015]
15. Apparatus according to claim 1, characterized by the fact that the housing (678) is not compatible.

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法律状态:
2018-12-18| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|

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2020-08-04| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

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2020-11-17| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 18/01/2012, OBSERVADAS AS CONDICOES LEGAIS. |

优先权:

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申请号 | 申请日 | 专利标题

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US201161433896P| true| 2011-01-18|2011-01-18|

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US61/433,896|2011-01-18|

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US201161486720P| true| 2011-05-16|2011-05-16|

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US61/486,720|2011-05-16|

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PCT/US2012/021753|WO2012099979A1|2011-01-18|2012-01-18|Inflatable medical devices|

---