Composite medical balloon with hybrid outer layer and related production methods

Abstract

A composite medical balloon includes a base balloon layer including a first tapered portion and a second tapered portion (108) with a barrel portion (106) therebetween. The base balloon includes one or more fiber layers. A hybrid layer is applied over the base balloon, such as over the fiber layers. The hybrid layer includes a tube (70) for covering the barrel portion (106) and a spiral wrap (80) for covering one or both of the first and second tapered portions (108). Related methods of forming such balloons are also disclosed.

Description

Background Technology

[0001] Medical balloons are widely used in medical procedures. Typically, an uninflated medical balloon is inserted into the body space. When the medical balloon inflates, its volume expands, and the body space expands similarly.

[0002] In procedures such as angioplasty, medical balloons can be used to open collapsed or blocked arteries. A typical medical balloon comprises a central cylindrical portion between a tapered or conical section. Medical balloons can be provided in a non-compliant form by including one or more fibrous layers, and compliant and semi-compliant forms are also known in the art.

[0003] To provide the outer layer for medical balloons, it has been previously suggested to longitudinally cut the ends of a tubular membrane to form radially separated segments that can overlap to more precisely wrap around a tapered end when attached. However, this results in numerous longitudinal seams, which may be undesirable for some applications. Furthermore, if not performed with great care, the seam formation can produce inconsistent results, leading to longitudinally extending fins. The manufacturing process involving cutting the outer layer preform is complex and expensive, typically requiring a completely manual process.

[0004] Therefore, there is a need for a medical balloon that overcomes any or all of the aforementioned limitations, as well as any other possible unidentified limitations. Summary of the Invention

[0005] The purpose of this disclosure is to provide a composite medical balloon comprising a hybrid layer including a tube for covering a cylindrical portion and a helical wrapping for covering one or both of a tapered or conical portion.

[0006] According to a first aspect of this disclosure, a composite medical balloon includes a base balloon layer comprising a first tapered portion and a second tapered portion, and a cylindrical portion between the first tapered portion and the second tapered portion. The hybrid layer includes a tube for covering the cylindrical portion and a helical wrapping for covering at least one of the first tapered portion and the second tapered portion.

[0007] In one embodiment, the tube comprises an extruded or blow-molded material, the length of which is substantially equal to the cylindrical portion of the base balloon layer. The tube may comprise a polyamide, and the base balloon layer may also comprise a polyamide. The helical wrapping may comprise a spirally wound strip of material extending from a proximal end of the at least one tapered portion to a distal end of the at least one tapered portion. The helical wrapping may overlap the tube at the transition from the at least one tapered portion to the cylindrical portion. The helical wrapping may comprise a polyether block amide, such as PEBAX, and may cover both tapered portions of the base balloon layer. The balloon may further comprise a fiber layer on the base balloon layer.

[0008] According to another aspect of this disclosure, a composite medical balloon is provided. The composite medical balloon includes a balloon comprising a first tapered portion and a second tapered portion, with a cylindrical portion between the first tapered portion and the second tapered portion. A hybrid layer is adhesively attached to the balloon. The hybrid layer includes a tube for covering the cylindrical portion, a first helical wrapping material strip for covering the first tapered portion, and a second helical wrapping material strip for covering the second tapered portion.

[0009] In one embodiment, the first helical wrapping material strip includes multiple overlapping wraps, including a wrap of the edge of an overlapping tube, the edge being adhesively bonded at the overlap. The tube and the balloon may each comprise the same material, such as polyamide (nylon). The first and second helical wrapping material strips comprise polyether block amide (PEBAX). The tube may be substantially equal in length to the length of the tubular portion of the base balloon layer. The balloon may also include a fiber layer.

[0010] Another aspect of this disclosure relates to a method of forming a composite medical balloon. The method includes providing a balloon having a cylindrical portion between a first tapered portion and a second tapered portion. The method further includes forming a hybrid layer on the balloon by applying a tube to the cylindrical portion of the balloon and applying a helical wrapping along one or both of the first and second tapered portions.

[0011] In one embodiment, the method includes a step of providing an adhesive to the balloon prior to the formation step. The method may also include steps of inflating the balloon prior to the adhesive application step, deflating the balloon prior to the tubing application step, and re-inflating the balloon prior to the application of the helical wrapping. The application of the helical wrapping step may include applying a strip of helical wrapping material to each of a first tapered portion and a second tapered portion of the balloon. The method may also include a step of laminating the balloon, tubing, and helical wrapping. Attached Figure Description

[0012] The above and further advantages of this disclosure can be better understood by referring to the following description in conjunction with the accompanying drawings, wherein:

[0013] Figure 1 A half-section of a medical balloon is shown;

[0014] Figure 2 The basal layer of the inflated balloon is shown;

[0015] Figure 3 A sac-like central axis was shown;

[0016] Figure 4 The balloon basement layer with an adhesive layer is shown;

[0017] Figure 5 The first fiber layer is shown;

[0018] Figure 6 The cross-sections of the balloon base layer, adhesive layer, and first fiber layer are shown.

[0019] Figure 7 Cross-sections of the balloon's basement, adhesive layer, and fiber layer are shown;

[0020] Figure 8 Cross-sections of the balloon base layer, adhesive layer, first fiber layer, second fiber layer, outer coating layer, and final layer are shown.

[0021] Figure 9 A fiber-reinforced medical balloon having a longitudinal first fiber layer and a circumferential second fiber layer is shown.

[0022] Figure 10 A fiber-reinforced medical balloon having a first angled fiber layer and a second longitudinal fiber layer is shown.

[0023] Figure 11 A fiber-reinforced medical balloon having a first longitudinal fiber layer and a second angled fiber layer is shown.

[0024] Figure 12 A fiber-reinforced medical balloon having a longitudinal first fiber layer and an angled second fiber layer is shown;

[0025] Figure 13 An alternative embodiment of the fiber-reinforced medical balloon is shown;

[0026] Figure 14 An alternative embodiment of the fiber-reinforced medical balloon is shown;

[0027] Figure 14 , 15 16, 17, 17A and 18 illustrate a manner for providing a fiber-reinforced medical balloon with a hybrid outer layer; and

[0028] Figure 19 , 20Figures 20A and 21 show medical balloons with a mixed outer layer forming part of a catheter.

[0029] For clarity, the dimensions of some elements may be exaggerated relative to others, or several physical components may be included in a functional block or element. Furthermore, reference numerals may sometimes be repeated in these figures to indicate corresponding or similar elements. Additionally, some items depicted in the figures may be combined to form a single function. Detailed Implementation

[0030] Numerous specific details are set forth in the following detailed description to provide a thorough understanding of the invention. The disclosed embodiments may be practiced without these specific details. In other instances, well-known methods, processes, components, or structures may not have been described in detail to avoid obscuring the invention.

[0031] The principles and operation of the systems and methods of this disclosure can be better understood by referring to the accompanying drawings and description. The invention is not limited in its application to the details of the construction and arrangement of the components described in the following description or shown in the drawings. The invention can have other embodiments or be practiced or implemented in various ways. Furthermore, it should be understood that the wording and terminology used herein are for descriptive purposes and should not be considered limiting.

[0032] For clarity, certain features of the invention described in the context of individual embodiments may also be provided in combination in a single embodiment. Conversely, for brevity, various features of the invention described in the context of individual embodiments may also be provided individually or in any suitable sub-combination.

[0033] Reference Figure 1 A partial cross-section of an inflatable composite medical balloon 10 is shown. In the illustrated embodiment, and as further discussed in the following description, the balloon 10 may optionally be fiber-reinforced and thus substantially non-compliant, with limited inflation characteristics. Because the medical balloon 10 is non-compliant, its diameter 116 does not change substantially with increasing internal pressure once fully inflated. As further noted below, the use of a fiber layer is considered entirely optional.

[0034] The diameter 116 of the inflatable fiber-reinforced medical balloon 10 according to one embodiment may be approximately 10 mm, but may vary depending on the application. The length of the inflatable fiber-reinforced medical balloon 10 according to one embodiment may be approximately 8 cm. Balloons 10 with a length 118 of 2-200 cm or greater are feasible. The inclination angle of the tapered or conical portion 108 of the inflatable fiber-reinforced medical balloon 10 according to the disclosed embodiment may be approximately 20 degrees. Those skilled in the art will recognize that the fiber-reinforced balloon 10 can be made in various diameters 116 and lengths, and has various inclinations at the tapered or conical portion 108 of the balloon 10, without limitation.

[0035] The fiber-reinforced medical balloon 10 may include a base layer 100 formed of a thin polymer material and a first layer 12 made of thin inelastic fibers 13. The balloon 10 may include a second layer 14 composed of one or more fibers 15. An outer layer 16 may be included on the fiber layers 12, 14, as outlined in the following description.

[0036] Each fiber 13 is typically anchored relative to the other fibers in the first fiber layer 12 and the other fibers in the balloon 10. The thin, inelastic fibers 13 of the first fiber layer 12 are characterized by high tensile strength, which provides excellent burst strength. The fiber-reinforced balloon 10 also resists abrasion, cutting, and puncture. It can be recognized that the enhanced structural integrity can be achieved through fiber reinforcement.

[0037] Further reference Figure 2 The basal layer 100 can be in the shape of a standard medical balloon or any other suitable shape. The basal layer 100 typically includes a first neck 102, which can be formed as a thin cylinder configured to attach to the catheter shaft (see [link to catheter shaft]). Figure 19 , 20 (and 21). The second neck 110 may resemble a narrow tube in topography. The first neck 102 is formed adjacent to the first tapered portion or tapered portion 104. The first tapered portion 104 expands to engage with the cylindrical portion 106 having a working length 118, indicated by the first transition portion 114. The first tapered portion 104 is typically constructed at an angle of approximately 12 to 20 degrees. The central region or cylindrical portion 106 engages with the second tapered portion or tapered portion 108 at the second transition portion 112. The second tapered portion 108 engages with the second neck 110.

[0038] The substrate 100 is typically formed of a thin-film polymeric material or other suitable material with high strength relative to the film thickness. Polymers and copolymers that can be used for the substrate 100 include conventional polymers and copolymers used in medical balloon constructions, such as, but not limited to, polyethylene (PET), polycaprolactam, polyester, polyether, polyamide, polyurethane, polyimide, ABS, nylon, copolymers, polyester / polyether block copolymers, ionomer resins, liquid crystal polymers, and rigid rod polymers. The substrate 100 can typically be formed as a blow-molded balloon from a polymeric material such as polyamide (e.g., nylon).

[0039] A base layer 100 can be formed, which may include a polymer that has been cured into a balloon shape. This base layer 100 of cured polymer can form the inner wall of the polymeric inner wall of a fiber-reinforced balloon. (See reference...) Figure 3 The removable mandrel 122 can be used as a substrate for applying the polymer coating. After the polymer has cured, the mandrel 122 can be removed, such as by physical extraction, heating, or other known separation methods.

[0040] A removable balloon, similar to the base layer 100, can be used as the mandrel 122. The mandrel 122 can be made of a variety of materials. The mandrel 122 can be shaped to the desired inner wall of the finished balloon. The mandrel 122 can be made of a collapsible metal or polymer balloon, foam, wax, low-melting-point metal alloy, etc. Once the composite balloon is formed and laminated, the mandrel 122 (i.e., the base layer 100) can be removed by melting, dissolving, rupturing, compressing, pressurizing, or other suitable removal techniques.

[0041] Reference Figure 4 It is understood that a thin coating of adhesive 126 is applied to the expanded substrate 100 or the polymer-coated mandrel 122 before the first layer of inelastic fibers 12 is applied. When the fibers 13 are placed on the substrate 100, the adhesive 126 sufficiently binds the fibers 13 and holds them in place. According to one embodiment, a very thin coating of adhesive 126 is applied to the substrate 100, such as, for example, 1-MP adhesive, which is based on a polyurethane polymer and a known solution of methyl ethyl ketone and dichloromethane, but other forms of adhesive may also be used.

[0042] like Figure 5 and Figure 6As shown, one or more fibers 13 are applied to a base layer 100 to form a first fiber layer 12, which may be referred to as "primary winding". The fibers 13 in the first fiber layer 12 can be inelastic fibers, typically made of inelastic fiber materials. Inelastic fibers are those that have minimal elasticity or tensile strength within a given pressure range. Some fiber materials are generally classified as inelastic, but all fiber materials may have detectable but minimal elasticity or tensile strength under a given pressure. The fibers 13 in the first fiber layer 12 can be high-strength fibers, typically made of high-strength fiber materials. Some high-strength inelastic fiber materials may include Kevlar, Vectran, Spectra, Dacron, Dyneema, Terlon (PBT), Zylon (PBO), polyimide (PIM), other ultra-high molecular weight polyethylene, aromatic polyamides, etc.

[0043] In the disclosed embodiment, the fibers 13 of the first fiber layer 12 are strip-shaped, wherein the width of the fiber is greater than the thickness of the fiber. The fibers 13 may be flat, such that the fibers have a rectangular cross-section. The fibers 13 used in the initial fiber layer 12 may all be made of the same material and have the same shape. Fibers 13 made of different materials may be used in the initial fiber layer 12. Fibers 13 of different shapes may be used in the initial fiber layer 12. The first fiber layer 12 may be formed using ultra-high molecular weight (UHMW) polyethylene fibers 13 that have already been flattened on a roller mill. An adhesive such as 1-MP adhesive is applied to the flattened fibers 13. The fibers 13 may be arranged as 30 longitudinal fibers, each longitudinal fiber having a length substantially equal to the length of the balloon 10.

[0044] The fibers 13 of the initial fiber layer 12 can be arranged such that each fiber 13 is substantially parallel to the long axis of the balloon 10. The density of the fibers 13 in the initial fiber layer 12 is determined by the number of fiber wraps per inch, the number of fibers 13, and the thickness of the fibers 13. In the disclosed embodiment of the first fiber layer 12 having longitudinally arranged fibers 13, the fiber density is typically about 15 to 30 fibers 13, these fibers having a fiber thickness of about 0.0005 to 0.001 inches and being equidistant from each other, thereby providing sufficient strength for a standard-sized fiber-reinforced medical balloon 10. Each fiber 13 is substantially equal in length to the balloon 10. The first fiber layer 12 prevents longitudinal extension of the completed fiber-reinforced balloon 10.

[0045] According to one disclosed embodiment, a second fiber layer 14 made of one or more high-strength inelastic fibers 15 is positioned circumferentially along the balloon 10, such as... Figure 7As shown. The circumferentially placed fibers 15 may be transverse to or substantially transverse to the longitudinal axis of the balloon 10. The circumferential fibers 15 can prevent or minimize the expansion of the balloon diameter 116 under pressures between the minimum inflation pressure and the balloon rupture pressure.

[0046] The fibers 15 of the second fiber layer 14 can be inelastic fibers, typically made of inelastic fiber materials. Inelastic fibers are components composed of a group of fibers that have minimized elasticity or tensile strength within a given pressure range. Some fiber materials are generally classified as inelastic, but all fiber materials can have detectable but minimized elasticity or tensile strength under a given pressure. The fibers 15 of the second fiber layer 14 can be high-strength fibers, typically made of high-strength fiber materials. Some high-strength inelastic fiber materials may include Kevlar, Vectran, Spectra, Dacron, Dyneema, Terlon (PBT), Zylon (PBO), polyimide (PIM), other ultra-high molecular weight polyethylene, aromatic polyamides, etc.

[0047] In one disclosed embodiment, the fibers 15 of the second fiber layer 14 are strip-shaped, wherein the width of the fiber is greater than the thickness of the fiber. The fibers 15 may be flat, such that the fiber has a rectangular cross-section. The fibers 15 used in the second fiber layer 14 may all be made of the same material and have the same shape. Fibers 15 made of different materials may be used in the second fiber layer 14. Fibers 15 of different shapes may be used in the second fiber layer 14. The second fiber layer 14 may be formed using UHMW polyethylene fibers 15 that have already been flattened on a roller mill. A thin adhesive coating, such as 1-MP adhesive, is applied to the flattened fibers 15. The fibers 15 may be arranged as the second fiber layer 14, with a fiber density of 54 wound per inch.

[0048] The fibers 15 of the second fiber layer 14 may be perpendicular or substantially perpendicular to the longitudinally placed fibers 13 to form the first fiber layer 12. This transverse arrangement of the first fiber layer 12 and the second fiber layer 14 enables the fiber-reinforced balloon 10 to have maximum radial stability. The placement of the fiber layers 12 and 14 causes the force to be evenly distributed on the balloon surface, thereby creating pixelated pressure points of approximately equal shape, size, and density.

[0049] The fibers 13 of the first fiber layer 12 may be the same as or different from the fibers 15 of the second fiber layer 14. Specifically, the fibers 15 of the second fiber layer 14 may be made of one or more materials different from the fibers 13 of the first layer 12. The shape of the fibers 15 of the second layer 14 may differ from that of the fibers 13 of the first fiber layer 12. The properties of the fibers or fiber combinations used in the first or second fiber layer can be determined according to the specific properties required for the resulting fiber-reinforced balloon 10.

[0050] Regarding the fiber density of the second fiber layer 14, according to the disclosed embodiment, fibers 15 having a thickness of about 0.0005 to 0.001 inches and arranged in parallel lines of about 50 to 80 turns per inch provide substantially sufficient strength. Individual fibers 15 may form the second fiber layer 14, wherein the fibers 15 are wound in a series of substantially parallel circumferential continuous loops.

[0051] Reference Figure 8 The diagram shows a cross-section of the integral layers of a fiber-reinforced medical balloon 10. A first fiber layer 12 and a second fiber layer 14 may be coated with an outer layer 16. In the disclosed embodiments, the outer layer 16 may be a hybrid outer layer, as further outlined in the following description. The composite structure typically includes a base layer 100, an adhesive 126, a first fiber layer 12, a second fiber layer 14, and an outer layer 16, thereby forming a composite non-compliant fiber-reinforced balloon 10 particularly suitable for medical applications. Typically, fibers 13 and 15 are fixed when the fiber-reinforced balloon 10 initially collapses and then expands and collapses during use.

[0052] Reference Figure 9 The diagram illustrates a fiber-reinforced balloon 10 according to a disclosed embodiment. In this embodiment, the fibers 13 are parallel to the long axis of the balloon 10.

[0053] Reference Figure 10 The diagram illustrates a fiber-reinforced balloon 45 according to another embodiment. The fiber-reinforced balloon 45 may include a first fiber layer 46 having fibers 47 angled to the longitudinal axis of the balloon 45. In this embodiment, neither the fibers 47 of the first fiber layer 46 nor the fibers 49 of the second fiber layer 48 are positioned parallel to the longitudinal axis of the balloon 45. According to one embodiment, the fibers 47 of the first fiber layer 46 may be positioned parallel to a line at a 5-degree angle relative to a line parallel to the longitudinal axis of the balloon 10. According to another embodiment, the fibers 47 of the first fiber layer 46 may be positioned parallel to a line at a 20-degree angle relative to a line parallel to the longitudinal axis of the balloon 10.

[0054] According to another embodiment, the fibers 47 of the first fiber layer 46 can be positioned parallel to a line at a 30-degree angle relative to a line parallel to the longitudinal axis of the balloon 10. According to another embodiment, the fibers 47 of the first fiber layer 46 can be positioned parallel to a line at a 45-degree angle relative to a line parallel to the longitudinal axis of the balloon 10. It will be apparent to those skilled in the art that the fibers 47 can be placed at any suitable angle.

[0055] The fibers 49 of the second fiber layer 48 are arranged parallel to the circumferential direction of the balloon 10. (Refer to...) Figure 11The image shows a fiber-reinforced balloon 40 according to another embodiment. The fiber-reinforced balloon 40 may include a second fiber layer 43 having fibers 44 disposed at an angle to the circumference of the balloon 40. According to one embodiment, the fibers 44 of the second fiber layer 43 may be positioned parallel to a line at a 5-degree angle relative to a line parallel to the circumference of the balloon 10.

[0056] The fibers 44 of the second fiber layer 43 can be positioned parallel to a line at a 20-degree angle relative to a line parallel to the circumference of the balloon 10. According to one embodiment, the fibers 44 of the second fiber layer 43 can be positioned parallel to a line at a 30-degree angle relative to a line parallel to the circumference of the balloon 10. According to one embodiment, the fibers 44 of the second fiber layer 43 can be positioned parallel to a line at a 45-degree angle relative to a line parallel to the circumference of the balloon 10. It will be apparent to those skilled in the art that the fibers 44 can be placed at any suitable angle.

[0057] The fibers 42 of the first fiber layer 41 and the fibers 44 of the second fiber layer 43 are positioned perpendicular to each other. (Refer to...) Figure 12 The image shows a fiber-reinforced balloon 50 according to another embodiment. The fiber-reinforced balloon 50 may include fibers 52 of a first fiber layer 51 and fibers 54 of a second fiber layer 53 positioned at a non-right-angled angle relative to each other.

[0058] Reference Figure 13 The medical balloon 60 may also include a single continuous fiber forming longitudinal fiber strands 64 and circumferential fiber strands 66. Specifically, fiber 62 may circumferentially wrap around one end portion (such as neck portion 102) and longitudinally guide towards another end portion or neck portion 110 (which may be at a non-zero angle to the longitudinal axis). Fiber 62 then wraps around the other end portion 110 and returns in the opposite longitudinal direction (again, at a non-zero angle). The single continuous fiber 62 may continue to wrap back and forth along the balloon 60 for a desired number of longitudinal strokes, and then circumferentially or helically around the balloon 60 at a desired fiber spacing. A more complete description of applying a single continuous fiber to the medical balloon 60 can be found in U.S. Patent No. 10,485,949.

[0059] Go to Figure 14The diagram illustrates the manner in which the outer layer 16 of the balloon 10 is formed (which can be applied to any embodiment of the balloon described herein). The balloon 10, as shown, is fiber-reinforced and therefore comprises one or more fiber layers, with any mandrel (if present) removed. An adhesive coating, such as 1-MP, is then applied, at least partially, to the cylindrical portion 106 of the thus-formed balloon 10, and is at least partially collapsed. The adhesive coating can be applied to the balloon 10 by spraying using a sprayer 150, as shown, but other application methods such as dip coating, splashing, brushing, rolling, etc., can also be used. Although... Figures 14 to 17 One or more fiber layers are shown; however, these fiber layers are entirely optional.

[0060] The tube 70 is then positioned on an adhesive coating applied to the base layer 100 and any overlying fiber layers 12, 14. The tube 70 may correspond in length 118 to the cylindrical portion 106 and have an inner diameter 116, which may be equal to or greater than the outer diameter of the balloon 10, or may be smaller in diameter and stretched by the base layer 100 upon expansion. The tube 70 may be made of the same material as the base layer 100 (e.g., nylon or PET film) and may be formed by extrusion or blow molding. The tube 70 may also be formed by blow molding a balloon-like structure similar to the base layer 100 and cutting off the tapered portions 104, 108, thereby producing a tube with a shape and size similar to the cylindrical portion 106.

[0061] The balloon 10, with its adhesive coating and tube 70 positioned above the cylindrical portion 106, is then inflated. This is achieved by supplying pressurized fluid (air) from the source 160 via a neck portion 110 and providing a seal 204 at the open end of the other neck portion 102. As the balloon 10 inflates, a different material is applied in the same layer as the tube 70 in the cylindrical portion 106 to at least one of the conical portions 104, 108. Specifically, a material strip 80, such as a material strip comprising a polymer membrane (e.g., a pre-stretched PEBAX membrane). The material 80 may have a thickness similar to that of the tube 70 and may be spirally wrapped or wound around one or both of the conical portions 104, 108 to form a spiral wrap. The width of the material 80 may be relatively narrow, requiring two or more passes or wraps to cover the entire portion of each conical portion 104, 108, but the arrangement will ultimately depend on the relative dimensions of the material 80 and the conical portions 104, 108. The adhesive may also be applied to the material 80 during spiral wrapping, but may also be applied directly to the tapered portions 104, 108, either alternatively or additionally.

[0062] The winding of material 80 can be done by overlapping. Specifically, each roll and pass of material strip 80 can overlap at least partially with the adjacent roll (as indicated by the dashed line O indicating the overlap). Furthermore, as by... Figure 17A As can be understood from the cross-sectional view, the material strip 80 can overlap with the edge of the tube 70 at the transitions 112, 114 adjacent to the tapered portions 104, 108. Alternatively, if the material strip 80 is applied first, the edge of the tube 70 can overlap with it. Adhesive can be added between the overlapping areas to help ensure a seamless bond and transition between the areas.

[0063] With all the spiral wraps of tube 70 and material 80 in place, the balloon 10 can be laminated or consolidated, such as by placing it within the assembly mold 300, as... Figure 18 As shown. Heat and pressure (note: expansion source 202 and heater 203 are connected to mold 300) can then be applied to balloon 10 to actuate the previously applied adhesive and allow it to flow along the interface between tube 70 and material 80 and the underlying base layer 100. Thus, tube 70 and spirally wrapped material 80 are fully bonded in place and connected to the underlying layers, such as base layer 100 or any existing fiber layers 12, 14.

[0064] Advantageously, this results in a balloon 10 with a hybrid outer layer 16, which offers several distinct advantages. Specifically, the ability to provide a continuous or seamless tube 70 for the cylindrical portion 106 allows for the selection of materials with superior properties (e.g., porosity, texture, stiffness, etc.) in any relevant processing aspect, such as delivery of therapeutic agents or drugs coated on the cylindrical portion (e.g., paclitaxel), or stent retention / release. Using different materials to cover the conical portions 104, 108 allows these regions of the composite balloon 10 to be provided with different properties, such as enhanced flexibility or different thicknesses. The use of helical wrapping further avoids the need to coil or fold the material around the conical portions 104, 108—which would cause the material to bundle together when the balloon is laminated and / or folded. Such bundled material could also unwind during balloon inflation during manufacturing, leading to processing problems, which is avoided by using helical wrapping.

[0065] Go to Figure 19It is understood that balloon 10 may form part of catheter 200 having a shaft 214 having a distal end portion 211 to which balloon 10 is mounted. Balloon 10 is sealed at its end to allow inflation through one or more inflatable lumens 217 extending within the catheter shaft 214 and communicating with the interior of balloon 10. Catheter 200 may also include a guidewire lumen 223 formed by shaft 224, which may be located within shaft 214 and, more specifically, within inflatable lumen 217. Lumen 223 guides guidewire 226 through catheter 200 (see...). Figure 20A ), and along the distal end portion that allows the balloon 10 to be positioned, including the distal tip 232 passing through the distal end of the balloon 10.

[0066] like Figure 20 As shown, the guidewire 226 can extend through the proximal end portion of the catheter 200 into the lumen 223 via a first port 225 of the connector or seat 227 located at the proximal end portion 213 of the shaft 214 to achieve an "over-the-wire" (OTW) arrangement, but can also be configured as a "quick-change" (RX) configuration (in which the guidewire 226 has an optional lateral opening 214a closer to the distal end of the balloon 10 than the proximal end (see...)). Figure 21 The second port 229 can exit from the shaft 214 at the tip 232 or be advanced through the channel (“short” RX; not shown) on the distal side of the balloon 10. The second port 229 can also be associated with the catheter 200, such as via the connector 227, for introducing fluid (e.g., saline, contrast agent, or both) into the internal compartment of the balloon 10 via the expansion chamber 217.

[0067] Although the above embodiments are shown and described as balloons with fibrous layers, it should be understood that this is considered an optional feature. Therefore, as proposed, balloon 10 may simply comprise a base layer 100 and a hybrid outer layer, without fibers. Furthermore, any type of intermediate layer may be disposed between the base balloon layer 100 and the hybrid outer layer to provide a resulting balloon with desired characteristics, such as a particular degree of compliance or enhanced rupture resistance.

[0068] In summary, this disclosure may be considered to be related to the following items:

[0069] 1. A composite medical balloon, comprising:

[0070] A basal balloon layer, the basal balloon layer including a first tapered portion and a second tapered portion, and having a cylindrical portion between the first tapered portion and the second tapered portion; and

[0071] The hybrid layer includes a tube for covering the cylindrical portion and a spiral wrapping for covering at least one of the first tapered portion and the second tapered portion.

[0072] 2. The composite medical balloon according to claim 1, wherein the tube comprises an extruded material or a blow-molded material.

[0073] 3. The composite medical balloon according to item 1 or item 2, wherein the tube comprises polyamide.

[0074] 4. The composite medical balloon according to any one of items 1-3, wherein the base balloon layer comprises polyamide.

[0075] 5. The composite medical balloon according to any one of claims 1-4, wherein the helical wrapping comprises a helically wound strip of material extending from the proximal end of the at least one tapered portion to the distal end of the at least one tapered portion.

[0076] 6. The composite medical balloon according to any one of claims 1-5, wherein the spiral wrapping overlaps with the tube at the transition from the first tapered portion or the second tapered portion to the cylindrical portion.

[0077] 7. The composite medical balloon according to any one of items 1-6, wherein the helical wrapping comprises polyether block amide.

[0078] 8. The composite medical balloon according to any one of claims 1-7 further includes a spiral wrapping covering the other of the first tapered portion or the second tapered portion.

[0079] 9. The composite medical balloon according to any one of claims 1-8, wherein the length of the tube is substantially equal to the length of the cylindrical portion of the base balloon layer.

[0080] 10. The composite medical balloon according to any one of claims 1-9, further comprising one or more fibrous layers between the base balloon layer and the hybrid layer, the fibrous layers comprising, for example, longitudinal fibrous layers and angled (circumferential) fibrous layers in any order.

[0081] 11. A composite medical balloon, comprising:

[0082] A balloon, the balloon comprising a first tapered portion and a second tapered portion, and having a cylindrical portion between the first tapered portion and the second tapered portion; and

[0083] A hybrid layer is adhesively attached to the balloon, the hybrid layer comprising a tube for covering the cylindrical portion, a first spiral wrapping material strip for covering the first tapered portion, and a second spiral wrapping strip for covering the second tapered portion.

[0084] 12. The composite medical balloon according to claim 11, wherein the first spiral wrapping material strip comprises a plurality of overlapping rolls, including a roll that overlaps with the edge of the tube, or alternatively overlaps with the edge of the tube.

[0085] 13. The composite medical balloon according to item 11 or 12, wherein the tube comprises polyamide.

[0086] 14. The composite medical balloon according to any one of items 11-13, wherein the balloon comprises polyamide.

[0087] 15. The composite medical balloon according to any one of claims 11-14, wherein the first spiral wrapping material strip and the second spiral wrapping material strip comprise polyether block amide.

[0088] 16. The composite medical balloon according to any one of claims 11-15, wherein the length of the tube is substantially equal to the length of the cylindrical portion of the balloon.

[0089] 17. The composite medical balloon according to any one of claims 11-16 further comprises one or more fibrous layers located between the balloon and the hybrid layer in any order, the fibrous layers comprising, for example, longitudinal fibrous layers and angled (circumferential) fibrous layers.

[0090] 18. A method for forming a composite medical balloon, comprising:

[0091] A balloon having a cylindrical portion between a first tapered portion and a second tapered portion is provided;

[0092] A hybrid layer is formed on the balloon by applying a tube over the cylindrical portion of the balloon and applying a helical wrapping along one or both of the first and second tapering portions.

[0093] 19. The method of claim 18 further includes the step of providing an adhesive to the balloon prior to the formation step.

[0094] 20. The method of claim 19 further includes the steps of inflating the balloon before the step of providing the adhesive, collapsing the balloon before the step of applying the tube, and re-inflating the balloon before the step of applying the spiral wrapping.

[0095] 21. The method according to any one of claims 18-20, wherein the step of applying the spiral wrapping material comprises applying a strip of spiral wrapping material to each of the first tapered portion and the second tapered portion of the balloon.

[0096] 22. The method according to any one of claims 18-21, further comprising the step of laminating the balloon, the tube, and the spiral wrapping.

[0097] 23. The method according to any one of claims 18-22 further includes the step of applying one or more fiber layers to the balloon in any order, the fiber layers including, for example, longitudinal fiber layers and angled (circumferential) fiber layers.

[0098] As used herein, the following terms have the following meanings:

[0099] Unless the context clearly specifies otherwise, the terms “a,” “a,” and “the” used herein refer to both the singular and the plural. For example, “a compartment” means one or more compartments.

[0100] As used herein, the terms "approximately," "substantially," or "approximately" relating to measurable values ​​such as parameters, quantities, durations, etc., mean variations of + / -20% or less, including + / -10% or less, + / -5% or less, + / -1% or less, and + / -0.1% or less, which are suitable for implementation in the disclosed invention to date. However, it should be understood that the values ​​referred to by the modifier "approximately" are themselves specifically disclosed.

[0101] As used herein, “comprise,” “comprising,” “comprises,” “comprised of,” and “include,” “including,” “includes,” or “contain,” “containing,” “contains” are synonymous and are inclusive or open-ended terms that specify the presence of subsequent, such as components, and do not exclude or prevent the presence of additional, unlisted components, features, elements, components, or steps known in the art or disclosed herein.

[0102] Although the invention has been described in conjunction with specific embodiments, many alternatives, modifications, and variations will be apparent to those skilled in the art. Therefore, the invention includes all such alternatives, modifications, and variations falling within the spirit and scope of the appended claims. All publications, patents, and patent applications mentioned in this specification are incorporated herein by reference in their entirety to the same extent that each individual publication, patent, or patent application is specifically and independently indicated to be incorporated herein by reference. Furthermore, the identification of any reference in this application should not be construed as an admission that such reference provides prior art as disclosed herein.

Claims

1. A composite medical balloon, comprising: The basal balloon layer includes a first tapered portion and a second tapered portion, and has a cylindrical portion between the first tapered portion and the second tapered portion; and A hybrid layer above the base balloon layer, the hybrid layer comprising a seamless tube for covering the cylindrical portion and a helical wrapping in the same layer as the seamless tube for covering at least one of the first tapered portion and the second tapered portion. The seamless tube and the spiral wrapping are separate components, but are joined together by overlapping.

2. The composite medical balloon according to claim 1, wherein, The seamless tube comprises extruded material or blow-molded material.

3. The composite medical balloon according to claim 1, wherein, The seamless tube comprises polyamide.

4. The composite medical balloon according to claim 3, wherein, The basement balloon layer comprises polyamide.

5. The composite medical balloon according to claim 1, wherein, The spiral wrapping comprises a spirally wound strip of material extending from one end of the first tapered portion or the second tapered portion to the other end of the corresponding tapered portion.

6. The composite medical balloon according to claim 1, wherein, The spiral wrapping overlaps with the seamless tube at the transition from the first tapered portion or the second tapered portion to the cylindrical portion.

7. The composite medical balloon according to claim 1, wherein, The spiral wrapping material comprises polyether block amide.

8. The composite medical balloon of claim 1 further includes a spiral wrapping covering the other of the first tapered portion or the second tapered portion.

9. The composite medical balloon according to claim 8, wherein, The length of the seamless tube is substantially equal to the length of the cylindrical portion of the base balloon layer.

10. The composite medical balloon of claim 1, further comprising one or more fibrous layers between the base balloon layer and the hybrid layer.

11. The composite medical balloon according to claim 1, wherein, The seamless tube and the spiral wrapping are made of different materials, and the seamless tube is suitable for delivering therapeutic agents or drugs coated on the tubular portion or for stent retention and release, while the spiral wrapping has enhanced flexibility.

12. A composite medical balloon, comprising: A balloon, the balloon including a first tapered portion and a second tapered portion, and having a cylindrical portion between the first tapered portion and the second tapered portion; and A hybrid layer is adhesively attached to the balloon, the hybrid layer comprising a seamless tube for covering the cylindrical portion and a first spiral wrapping material strip in the same layer as the seamless tube for covering the first tapered portion and a second spiral wrapping material strip for covering the second tapered portion. The seamless tube, the first spiral wrapping material strip, and the second spiral wrapping material strip are separate and are joined together by overlapping.

13. The composite medical balloon according to claim 12, wherein, The first spiral wrapping material strip includes multiple overlapping rolls, one of which overlaps with the edge of the seamless tube.

14. The composite medical balloon according to claim 12, wherein, The seamless tube comprises polyamide.

15. The composite medical balloon according to claim 14, wherein, The balloon comprises polyamide.

16. The composite medical balloon according to claim 12, wherein, The first spiral wrapping material strip and / or the second spiral wrapping material strip comprise polyether block amide.

17. The composite medical balloon according to claim 12, wherein, The length of the seamless tube is substantially equal to the length of the cylindrical portion of the balloon.

18. The composite medical balloon of claim 12, further comprising a fiber layer located between the balloon and the hybrid layer.

19. A method for forming a composite medical balloon, comprising: A balloon having a cylindrical portion between a first tapered portion and a second tapered portion is provided; A hybrid layer is formed on the balloon by applying a seamless tube to the balloon above the cylindrical portion and by applying a helical wrapping material to the balloon along one or both of the first and second tapered portions. The seamless tube and the spiral wrapping are separate components, but are joined together by overlapping.

20. The method of claim 19, further comprising the step of providing an adhesive to the balloon prior to the formation step.

21. The method of claim 20, further comprising the steps of inflating the balloon prior to the step of providing the adhesive, collapsing the balloon prior to the step of applying the seamless tube, and re-inflating the balloon prior to the step of applying the spiral wrapping.

22. The method according to claim 19, wherein, The step of applying the spiral wrapping material includes applying a strip of spiral wrapping material to each of the first tapered portion and / or the second tapered portion of the balloon.

23. The method of claim 19, further comprising the step of combining the balloon, the seamless tube, and the spiral wrap by applying heat and pressure.

24. The method of claim 19, further comprising the step of applying one or more fiber layers to the balloon.

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