Medical balloon with reinforced braided fabric

Abstract

A balloon catheter (10) includes an inflatable balloon (12) and a braid (14) on an outer surface of the inflatable balloon. The inflatable balloon includes a middle portion (10C), a distal waist portion (30), and a transition portion (28) between the middle portion and the distal waist portion. At least a portion of the transition portion (28) has a taper angle of at least 40 degrees. The braid includes a plurality of threads, and a pitch between adjacent threads of the plurality of threads on the distal waist portion may be less than a pitch between adjacent threads of the plurality of threads on the intermediate portion. A pitch between adjacent lines of the plurality of lines on the transition portion gradually transitions on the transition portion from a pitch between adjacent lines on the intermediate portion to a pitch between adjacent lines on the distal waist portion.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Application No. 63 / 398,587, filed on August 17, 2022, the entire contents of which are incorporated herein by reference. Technical Field

[0003] Various aspects of the present disclosure generally relate to medical devices and related methods. More specifically, the present disclosure relates to medical devices and related methods for positioning and / or expanding balloons used in urological surgical procedures such as percutaneous nephrolithotomy or nephrolithotomy (PCNL). Background Art

[0004] Many medical procedures that once required open procedures can now be done with minimally invasive techniques that limit the size of the incision, thereby reducing recovery time and the risk of infection. For example, in the field of urology, kidney stones or renal stones accumulate in the urinary tract and become lodged in the kidneys. Kidney stones are deposits of substances in the urine, usually minerals and acid salts. Although smaller stones can be excreted naturally, larger stones may require surgery to remove. Although open surgery was once the standard treatment for removing stones, other minimally invasive techniques, such as ureteroscopy and percutaneous nephrolithotomy or renal lithotripsy (hereinafter referred to as "PCNL"), have become safer and more effective alternatives. PCNL surgery typically involves delivering a sheath (i.e., a renal sheath) to the kidney to help remove one or more kidney stones. The sheath can be delivered to one or more kidney stones via a balloon catheter. However, the size, shape, thickness, etc. of the balloon catheter may limit the sheath's access to one or more kidney stones.

[0005] The apparatus and method of the present disclosure may correct some of the above-mentioned deficiencies or address other aspects of the prior art. Summary of the invention

[0006] Examples of the present disclosure relate particularly to medical devices and methods.Each example disclosed herein may include one or more features described in conjunction with any other disclosed example.

[0007] In one example, a balloon catheter may include an expandable balloon and a braid on an outer surface of the expandable balloon. The expandable balloon may include a middle portion, a distal waist, and a transition portion between the middle portion and the distal waist. At least a portion of the transition portion may have a taper angle of at least 40 degrees. The braid may include a plurality of wires, and the spacing between adjacent wires of the plurality of wires on the distal waist may be less than the spacing between adjacent wires of the plurality of wires on the middle portion. The spacing between adjacent wires of the plurality of wires on the transition portion may gradually transition from the spacing between adjacent wires on the middle portion to the spacing between adjacent wires on the distal waist on the transition portion.

[0008] The balloon catheter may include one or more of the following aspects. Multiple threads may include multiple clockwise threads, multiple counterclockwise threads, and multiple longitudinal threads. Multiple clockwise threads, multiple counterclockwise threads, and multiple longitudinal threads may be woven together on the outer surface of the expandable balloon. In the middle portion, transition portion, and distal waist, multiple threads may include the same number of clockwise threads, counterclockwise threads, and longitudinal threads. The balloon catheter may also include a thermoplastic polyurethane layer formed on at least a portion of the expandable balloon between the expandable balloon and the braid. The thermoplastic polyurethane layer may be a first thermoplastic polyurethane layer, and the balloon catheter may also include a second thermoplastic polyurethane layer formed on at least a portion of the braid. The balloon catheter may also include a silicon-based lubricating coating on the outside of the balloon catheter.

[0009] The inflatable balloon may include an inner balloon wall and an outer balloon wall. The outer balloon wall may be configured to be spaced apart from the inner balloon wall at least in the middle portion and the transition portion when the inflatable balloon is inflated. The balloon catheter may also include a mandrel, and the inner balloon wall may be coupled to the mandrel. The inflatable balloon may include a diameter of 10 mm, and the transition portion may include a length of 8.5 mm. At least a portion of the transition portion may extend from the distal end of the middle portion at an angle of 25 degrees. The transition portion may be a distal transition portion, and the inflatable balloon may also include a proximal waist and a proximal transition portion between the middle portion and the proximal waist.

[0010] The balloon catheter can be configured for percutaneous nephrolithotomy or nephrolithotomy such that the distal waist is positioned adjacent to the stone. The plurality of wires can be fused together over at least a portion of the distal waist. The plurality of wires can be or include Vectran TM The balloon catheter may have a rated burst pressure of at least 30 atmospheres.

[0011] On the other hand, the method for forming a balloon catheter may include forming a base balloon, expanding and / or sealing the base balloon, and delivering and forming a braid on the outer surface of the base balloon. The base balloon may include an inner balloon wall and an outer balloon wall, and when the base balloon expands, the outer balloon wall is spaced apart from the inner balloon wall. The base balloon may include a middle portion, a distal waist, and a transition portion between the middle portion and the distal waist. When expanded, at least a portion of the transition portion may include a cone angle of at least 40 degrees. The braid may include multiple clockwise lines, multiple counterclockwise lines, and multiple longitudinal lines. The spacing between adjacent lines of the multiple lines on the distal waist may be less than the spacing between adjacent lines of the multiple lines on the middle portion. The spacing between adjacent lines of the multiple lines on the transition portion may gradually transition from the spacing between adjacent lines on the middle portion to the spacing between adjacent lines on the distal waist on the transition portion.

[0012] The method may include one or more of the following aspects. The braid may be formed with a braiding machine and by moving the base balloon at different speeds corresponding to the braiding angle and / or the portion of the base balloon receiving the braid. On the middle portion, transition portion, and distal waist, the plurality of threads may include the same number of clockwise threads, counterclockwise threads, and longitudinal threads. The method may also include, before the braid is delivered and formed on the outside of the base balloon, processing the outer surface of the balloon, and after the braid is delivered and formed on the outside of the base balloon, processing the outer surface of the braided balloon.

[0013] On the other hand, the balloon catheter may include an expandable balloon and a braid on the outer surface of the expandable balloon. The expandable balloon may include a middle portion, a proximal waist, a proximal transition portion between the proximal waist and the middle portion, a distal waist, and a distal transition portion between the middle portion and the distal waist. At least a portion of the distal transition portion may include a taper angle of at least 50 degrees. The braid may include a plurality of clockwise threads, a plurality of counterclockwise threads, and a plurality of longitudinal threads. The spacing between adjacent threads of the plurality of threads on the distal waist may be less than the spacing between adjacent threads of the plurality of threads on the middle portion. The spacing between adjacent threads of the plurality of threads on the transition portion may gradually transition from the spacing between adjacent threads on the middle portion to the spacing between adjacent threads on the distal waist on the transition portion.

[0014] The balloon catheter may include one or more of the following aspects: The plurality of wires may include an equal number of clockwise wires, counterclockwise wires, and longitudinal wires on the proximal waist, the proximal transition portion, the middle portion, the distal transition portion, and the distal waist.

[0015] It should be understood that the foregoing general description and the following detailed description are merely exemplary and illustrative, and are not limitations on the claimed invention. As used herein, the term "comprising" or any other variation thereof is intended to cover non-exclusive inclusions, such that a process, method, article, or device that includes the listed elements includes not only those elements, but may include other elements that are not explicitly listed or inherent to such a process, method, article, or device. The term "exemplary" means "example" rather than "ideal". The term "distal" refers to the direction away from the operator / toward the treatment site, and the term "proximal" refers to the direction toward the operator. The term "approximately" or similar terms (e.g., "substantially") include values ​​of + / -10% of the stated value. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate exemplary features of the disclosure and, together with the description, serve to explain the principles of the disclosure.

[0017] Figure 1 An exemplary medical device is shown.

[0018] Figure 2 Shows Figure 1 The distal portion of the medical device is free of braid.

[0019] Figure 3A Shown is a braided Figure 1 The distal portion of the medical device, Figure 3B It is woven Figure 1 A side cross-sectional view of a portion of a medical device.

[0020] Figure 4 According to aspects of the present disclosure, Figure 1 Flowchart of an exemplary method of a medical device DETAILED DESCRIPTION

[0021] Examples of the present disclosure include devices and methods for promoting and / or improving the efficacy, efficiency, cost and / or safety of medical procedures. Embodiments of the present disclosure may relate to devices and methods for performing various medical procedures and / or treating any other part of a kidney, ureter, bladder, urethra or urinary tract. In addition, embodiments of the present disclosure may relate to devices and methods for performing various medical procedures and / or treating any other part of a large intestine (colon), small intestine, cecum, esophagus, stomach or gastrointestinal tract or a biliary tree. In addition, embodiments of the present disclosure may relate to devices and methods for performing various medical procedures and / or treating, for example, parts of anatomical structures approached via a body cavity, such as larynx, trachea, bronchi (main bronchi), lobes (secondary bronchi), segments (tertiary bronchi) or any other part of the respiratory system. In these respects, the devices and methods discussed herein may be used to treat any other suitable object anatomical structure (collectively referred to herein as "treatment site").

[0022] Various embodiments described herein include single-use or disposable medical devices. Some aspects of the present disclosure can be used to perform endoscopy, arthroscopy, bronchoscope, ureteroscope, colonoscopy or other types of surgery. For example, the disclosed aspects can be used for ureteroscopes, endoscopes, duodenoscopes, gastroscopes, endoscopic ultrasonography ("EUS") mirrors, colonoscopes, bronchoscopes, laparoscopes, arthroscopes, cystoscopes, suction mirrors, sheaths, catheters, diagnostic or therapeutic tools or devices, or any other suitable delivery devices or medical devices, such as devices for treating through a body cavity. Alternatively, various embodiments described herein can be delivered to a treatment site alone and / or used separately from another scope or medical device. One or more elements discussed here can be metallic, plastic, or include any combination of shape memory metals (e.g., nitinol), shape memory polymers, polymers, or biocompatible materials.

[0023] Reference will now be made in detail to the examples of the present disclosure described above and shown in the accompanying drawings. Whenever possible, the same reference numerals will be used throughout the accompanying drawings to represent the same or similar parts. Note that one or more aspects of the medical systems, devices, and methods discussed herein can be combined and / or used together with one or more aspects of other medical systems, devices, and methods discussed herein.

[0024] Figure 1 A medical device, such as an exemplary balloon catheter 10, is shown. The balloon catheter 10 includes an expandable balloon 12 (balloon 12) and a fiber braid 14 (braid 14), such as on the outer surface or exterior of the balloon 12. The balloon catheter 10 may include a proximal portion 10A, a distal portion 10B, and, for example, an intermediate portion 10C between the proximal portion 10A and the distal portion 10B. As discussed in detail below, the balloon catheter 10 can be used to approach one or more treatment sites, such as being positioned near or adjacent to one or more kidney stones (i.e., on its proximal side). In addition, the shape, orientation, and / or arrangement of the braid 14 (i.e., the fibers forming the fiber braid 14) can vary on various portions of the balloon 12, such as to help support and maintain the balloon 12 when the balloon 12 is expanded.

[0025] The balloon catheter 10 may also include or be coupled to a mandrel 16, e.g., extending from a proximal portion 10A of the balloon catheter 10 to a distal portion 10B of the balloon catheter 10. The mandrel 16 may include, e.g., a proximal block 18 adjacent to a proximal-most end of a proximal waist 22 of the balloon 12, and the mandrel 16 may also include, e.g., a distal block 20 adjacent to a distal-most end of a distal portion 10B of the balloon catheter 10. In some aspects, the proximal block 18 and / or the distal block 20 may be formed by a radially extending portion of the mandrel 16. In addition, the balloon 12 may include a proximal waist 22, e.g., coupling the proximal waist 22 of the balloon 12 to the mandrel 16. The balloon 12 includes a proximal transition portion or proximal transition region 24, e.g., expanding from the proximal waist 22 to a mid-portion or barrel portion 26 of the balloon 12. In addition, the balloon 12 includes a distal transition portion or distal transition region 28, e.g., tapering from the mid-portion 26 to a distal waist 30 of the balloon 12. The distal waist 30 may couple the distal portion 10B of the balloon catheter 10 to the mandrel 16. The proximal transition region 24 and the distal transition region 28 may each be substantially conical.

[0026] like Figure 1As shown, the braid 14 can have different fiber densities on different parts of the balloon 12 (e.g., on different parts of the proximal portion 10A, the distal portion 10B, and the middle portion 10C of the balloon catheter 10). For example, when wrapped around the proximal waist 22, the braid 14 can have a first density. When wrapped around the middle portion 26, the braid 14 can have a second density, which is smaller than the first density. The braid 14 can, for example, gradually transition from the first density to the second density on at least a portion of the proximal transition region 24. In addition, when wrapped around the distal waist 30, the braid 14 can have a third density. The third density can be greater than the second density, for example, the same or substantially similar to the first density of the braid 14 on the proximal waist 22. The braid 14 can, for example, gradually transition from the second density to the third density on at least a portion of the distal transition region 28.

[0027] As follows about e.g. Figure 3A and 3B As described above, the braid 14 may include, for example, a plurality of fibers extending in a clockwise spiral when viewed from the distal end of the balloon catheter 10, and a plurality of fibers extending in a counterclockwise spiral when viewed from the distal end of the balloon catheter 10. In addition, the braid 14 may include a plurality of fibers extending longitudinally along the corresponding portion of the balloon 12. The clockwise spiral fibers, the counterclockwise spiral fibers, and the longitudinal fibers may be interwoven (see FIG. Figure 3A ) to form the braid 14. In addition, the spacing between individual fibers (i.e., between adjacent clockwise fibers, between adjacent counterclockwise fibers, and between individual longitudinal fibers) can vary between different portions of the balloon catheter 10, for example, to form the various braid densities described above.

[0028] As described herein, balloon catheter 10 can be used for percutaneous nephrolithotomy or renal lithotripsy (PCNL), to help break, remove or otherwise treat one or more kidney stones. In these respects, balloon catheter 10 can be used to deliver renal sheath, for example, through the incision in the patient, and arrive at the patient's kidney. Balloon catheter 10 can be used to deliver renal sheath to the position close to one or more kidney stones. In other respects, balloon catheter 10 can be used for one or more other operations, such as endoscopic retrograde pancreaticocholangiopancreatography (ERCP), balloon and laser angioplasty, nephrostomy, electrode placement, etc. In these respects, balloon catheter 10 can be used for, for example, to help remove or otherwise treat ureteral stones, bladder stones, gallstones, bile duct stones, polyps, stent placement, gastrointestinal anastomosis, common bile duct duodenal anastomosis, etc., and / or help one or more other sheaths delivered to the position in the patient.

[0029] Figure 2 The distal portion of the balloon 12 is shown. For clarity, Figure 2The braid 14 is omitted. As shown, the distal portion of the balloon 12 includes a portion of the middle portion 26, a distal transition region 28, and a distal waist 30. In addition, as shown, the distal waist 30 can be positioned close to the target site and / or object 40. In this aspect, the object 40 is a calculus (e.g., a kidney stone). However, as described above, the object 40 can be another type of object or tissue that is approached, removed, and / or otherwise treated by means of the balloon catheter 10.

[0030] like Figure 2 As shown, when the distal waist 30 is positioned close to the object 40, the middle portion 26 is spaced apart from the object 40 by a distance A. For example, the balloon 12 can include a taper angle of about 50 degrees on at least a portion of the distal transition region 28. In this aspect, the distal transition region 28 can taper in diameter between the middle portion 26 and the distal waist 30. In addition, the distal transition region 28 can taper inwardly at an angle θ of, for example, about 20 degrees or more (e.g., about 25 degrees) relative to an imaginary line extending longitudinally and / or tangentially from the middle portion 26. Therefore, the distal transition region 28 can form a taper angle of about 40 degrees or more (e.g., about 50 degrees), i.e., twice the angle θ. In these aspects, the balloon 10 can be a 10 mm diameter balloon, and the distal transition region 28 can include a longitudinal length B, for example, about 7-10 mm, for example, about 8.5 mm. Additionally, when the balloon catheter 10 is assembled with the inflated balloon 12 and the distal waist 30 positioned adjacent the object 40, the distal-most end of the intermediate portion 26 can be positioned approximately 12-15 mm, e.g., approximately 13.5 mm (i.e., distance A) from the object 40. In these aspects, the distal waist 30, the distal mass 20, and / or the distal portion of the mandrel 16 can account for the additional spacing between the distal-most end of the intermediate portion 26 and the object 40.

[0031] Although the distal waist 30 is Figure 2 40, but in some aspects, the distal waist 30 (and / or the distal block 20 or the distal portion of the mandrel 16, Figure 2 The distal transition region 28 and the distal waist 30 are shown as discontinuous joints or transitions, but the present invention is not limited thereto. Figure 3A As shown, the balloon 12 , and thus the balloon catheter 10 , may include a gradual junction or transition between the intermediate portion 26 and the distal transition region 28 , and between the distal transition region 28 and the distal waist 30 .

[0032] Figure 3AThe distal portion 10B of the balloon catheter 10 is shown, including the balloon 12 and the braid 14. Figure 3A As shown, the junction or transition between the middle portion 26 and the distal transition region 28 and between the distal transition region 28 and the distal waist 30 can be gradual. In addition, the distal transition region 28 can extend from the middle portion 26 at a certain angle, such as an angle θ (e.g., greater than about 20 degrees, such as about 25 degrees), thereby forming a cone angle greater than about 40 degrees, such as about 50 degrees. As described above, the distal transition region 28 can include a longitudinal length B, such as about 7-10mm, such as about 8.5mm. In addition, the braid 14 can terminate at the distal end of the distal coupling 32, such as at the distal portion of the distal waist 30. For example, the braid 14 can be fused together and / or fused to the distal waist 30 at the distal coupling 32.

[0033] As described above, the braid 14 can include a plurality of fibers extending in a clockwise spiral (clockwise fibers 34), for example, when viewed from the distal end of the balloon catheter 10, and a plurality of fibers extending in a counterclockwise spiral (counterclockwise fibers 36), for example, when viewed from the distal end of the balloon catheter 10. In some aspects, the braid 14 can include about sixteen clockwise fibers 34 and about sixteen counterclockwise fibers 36. In addition, the braid 14 can include a plurality of fibers extending longitudinally along a corresponding portion of the balloon 12 (longitudinal fibers 38). In some aspects, the braid 14 can include about sixteen longitudinal fibers 38.

[0034] The clockwise fibers 34, counterclockwise fibers 36, and longitudinal fibers 38 may be interwoven (see Figure 3A ) to form braid 14. For example, braid 14 can be formed by a braiding machine, for example, with a variable braid angle, as described below. In some aspects, one or more of clockwise fibers 34, counterclockwise fibers 36, and longitudinal fibers 38 can be or include Vectran TM Fiber. In addition, one or more portions of the braid 14 can be formed with a braiding machine and by moving the balloon 12 at various speeds, for example, depending on the braiding angle and / or the portion of the balloon 12 receiving the braid 14. For example, in some aspects, the braiding machine can deliver the braid 14 at similar or identical braiding angles on various portions of the balloon 12. However, the balloon 12 can be advanced or moved relative to the braiding machine at various speeds, thereby imparting various spacings between adjacent wires 34, 36, and 38 in the braid 14 on different portions of the balloon 12. In these aspects, the braid 14 (and therefore the balloon catheter 10) includes the same number of clockwise wires 34, counterclockwise wires 36, and longitudinal wires 38 throughout the balloon catheter 10, for example, at the middle portion 26, the distal transition region 28, and the distal waist 30 of the balloon 12.

[0035] In addition, the spacing between individual fibers (i.e., between adjacent clockwise fibers 34, between adjacent counterclockwise fibers 36, and between individual longitudinal fibers 38) can vary between different portions of the balloon catheter 10, for example, to form the various braid densities described above. Figure 1 and Figure 3A As shown, the clockwise fibers 34, the counterclockwise fibers 36, and the longitudinal fibers 38 can be separated and interwoven at a first pitch and / or a first interval on the middle portion 26 of the balloon 12. For example, the clockwise fibers 34 and the counterclockwise fibers 36 can be woven at a braiding angle between about 55 degrees and about 75 degrees, such as between about 60 degrees and about 70 degrees, such as about 65 degrees, on the middle portion 26 of the balloon 12. In addition, the clockwise fibers 34, the counterclockwise fibers 36, and the longitudinal fibers 38 can be separated and interwoven at a second pitch and / or a second interval on the distal waist 30 of the balloon 12. For example, the clockwise fibers 34 and the counterclockwise fibers 36 can be woven at a braiding angle between about 35 degrees and about 55 degrees, such as between about 40 degrees and about 50 degrees, such as about 45 degrees, on the distal waist 30 of the balloon 12.

[0036] The spacing and intervals of the interweaving of the clockwise fibers 34, the counterclockwise fibers 36, and the longitudinal fibers 38 can gradually transition over the distal transition region 28, for example, from the spacing and / or intervals over the middle portion 26 of the balloon 10 to the spacing and / or intervals over the distal waist 30 of the balloon 12. It should be noted that the longitudinal fibers 38 can extend along the outer surface of the balloon 12 parallel to the longitudinal axis of the balloon 12. However, the spacing between adjacent longitudinal fibers 38 on the distal waist 30 is less than the spacing between adjacent longitudinal fibers 38 on the middle portion 26, for example, gradually transitioning between the corresponding spacings over the distal transition region 28.

[0037] Figure 3B is a cross-sectional view of a portion of the balloon catheter 10, for example, at the middle portion 26 ( Figure 1 ). As shown, the inner balloon wall 42 can surround a portion of the mandrel 16. In addition, for example, when the balloon 12 is inflated, the outer balloon wall 44 can be radially spaced apart from the inner balloon wall 42. The inner balloon wall 42 and / or the outer balloon wall 44 can be formed of an elastic material, for example, including a flexible polyether and a rigid polyamide (e.g., ). A base layer 46 may be deposited or otherwise positioned radially outside of the outer balloon wall 44. The base layer 46 may be formed of thermoplastic polyurethane and may help the fibers 34, 36, and 38 adhere to the balloon 12 and / or maintain relative positions on the balloon 12.

[0038] Additionally, a fiber layer 48 may be deposited or otherwise positioned radially outwardly of the base layer 46. For example, as shown, the fiber layer 48 may include a plurality of clockwise fibers 34, a plurality of counterclockwise fibers 36, and a plurality of longitudinal fibers 38, as described above, to form the braid 14.

[0039] In addition, the outer layer 50 can be deposited or otherwise positioned radially outside the fiber layer 48. The outer layer 50 can be formed of thermoplastic polyurethane and can help surround or embed the fibers 34, 36, and 38. Although the outer layer 50 is shown as being radially outside the fiber layer 48 (i.e., the embedded fibers 34, 36, and 38), it should be noted that the outer layer 50 can also extend between the fibers 34, 36, and 38, for example, filling the space between adjacent fibers 34, 36, and 38 and / or abutting one or more portions of the base layer 46. In addition, in some aspects, the outer layer 50 can be at least partially lubricated, such as a silicone-based lubricating coating, which can facilitate the delivery of the balloon catheter 10, such as by helping to prevent adhesion to the balloon catheter 10. Alternatively or additionally, an additional outer coating (not shown) can be applied to at least a portion of the outer layer 50. The outer coating may also be at least partially lubricious, e.g., a silicone-based lubricious coating, which may aid in the delivery of the balloon catheter 10, e.g., by helping to prevent adhesion (i.e., adhesion of tissue) to the balloon catheter 10. In some aspects, the outer coating may be applied only to one or more portions of the middle portion 10C (i.e., the barrel portion) of the balloon catheter 10, which may aid in the delivery of the balloon catheter 10, e.g., by helping to prevent adhesion to the middle portion 10C, while still maintaining at least some adhesion properties of the distal portion 10B of the balloon catheter 10.

[0040] In addition, in some aspects, for example, on one or more portions of the middle portion 10C, the balloon catheter 10 can have a cross-sectional diameter between about 4 mm and about 14 mm, for example, about 10 mm. In addition, in some aspects, for example, on one or more portions of the distal portion 10B, the balloon catheter 10 can have a cross-sectional diameter between about 1.5 mm and about 3 mm, for example, between about 2.1 mm and about 2.8 mm, for example, about 2.35 mm.

[0041] Figure 4An exemplary method 400 is shown that can be performed to form a balloon catheter 10. In these aspects, a first step 402 includes forming a base balloon. As described above, the balloon 12 may include an inner balloon wall 42 and an outer balloon wall 44. One or more of the inner balloon wall 42 and the outer balloon wall 44 may be formed by one or more extrusions. One or more of the inner balloon wall 42 and the outer balloon wall 44 may be stretched, molded and / or trimmed, for example, to form a desired size and / or shape of the balloon 12. The inner balloon wall 42 may be coupled to the mandrel 16 or otherwise positioned around the mandrel. The outer balloon wall 44 may be coupled to the inner balloon wall 42, for example, at a proximal end and a distal end, thereby allowing the outer balloon wall 44 to expand. In some aspects, such as Figure 3B As shown, the outer balloon wall 44 may include a greater radial thickness than the inner balloon wall 42, for example, to help maintain the shape and / or structure of the balloon 12 when expanded. As described above, the inner balloon wall 42 and / or the outer balloon wall 44 may be formed of an elastic material, for example, including flexible polyethers and rigid polyamides (e.g., ).

[0042] Next, step 404 includes inflating and / or sealing balloon 12. For example, air can be delivered to the area between inner balloon wall 42 and outer balloon wall 44 to assist in inflating balloon 12. Additionally or alternatively, proximal and / or distal portions of inner balloon wall 42 and outer balloon wall 44 can be coupled together and / or otherwise sealed.

[0043] In optional step 406, method 400 may include treating the outer surface of balloon 12. For example, optional step 406 may include one or more of plasma treatment, primer coating (e.g., thermoplastic polyurethane coating), and / or annealing the primer coating. In this regard, optional step 406 may include depositing a base layer 46 on the outside of outer balloon wall 44, and base layer 46 may help fibers 34, 36, and 38 adhere to balloon 12 and / or maintain relative positions on balloon 12.

[0044] Next, method 400 includes step 408, which includes delivering and forming braid 14 on the outer surface or exterior of balloon 12. As described above, braid 14 (i.e., including clockwise fibers 34, counterclockwise fibers 36, and longitudinal fibers 38) can be deposited on the outer surface of outer balloon wall 44, such as by a braiding machine (e.g., with a variable braiding angle) to form fiber layer 48. In some aspects, one or more of clockwise fibers 34, counterclockwise fibers 36, and longitudinal fibers 38 can be or include Vectran TMFibers, and the spacing between adjacent fibers 34, 36, 38 can vary on different portions of the balloon 12. In addition, one or more portions of the braid 14 can be formed with a braiding machine and by moving the balloon 12 at various speeds, for example, depending on the braiding angle and / or the portion of the balloon 12 receiving the braid 14. For example, in some aspects, the braiding machine can deliver the braid 14 at similar or identical braiding angles on various portions of the balloon 12. However, the balloon 12 can be advanced or moved relative to the braiding machine at various speeds, thereby imparting various spacings between adjacent wires 34, 36, and 38 in the braid 14 on different portions of the balloon 12. In these aspects, the balloon 12 can be advanced manually relative to the braiding machine, or can be advanced automatically and / or mechanically relative to the braiding machine.

[0045] In some aspects, method 400 may include an optional step 410, which includes treating the outer surface of the braided balloon (i.e., the balloon 12 with the braid 14). In these aspects, the optional step 410 may include one or more of plasma treatment, top coating (e.g., thermoplastic polyurethane coating) and / or annealing the top coating. In this regard, the optional step 410 may include depositing an outer layer 50 on the outside of the fiber layer 48. The outer layer 50 may be formed of thermoplastic polyurethane and may help to surround or embed the fibers 34, 36 and 38. As described above, in some aspects, the outer layer 50 may be at least partially lubricated, for example, a silicone-based lubricating coating, which may help prevent adhesion to the balloon catheter 10. Alternatively or additionally, an additional outer coating (not shown) may be applied to at least a portion of the outer layer 50. The outer coating may also be at least partially lubricated, for example, a silicone-based lubricating coating, which may help prevent adhesion to the balloon catheter 10. In some aspects, the outer coating may be applied only to one or more portions of the middle portion 10C (ie, the barrel portion) of the balloon catheter 10 , which may help prevent adhesion to the middle portion 10C while still maintaining at least some adhesion properties of the distal portion 10B of the balloon catheter 10 .

[0046] Finally, in some aspects, method 400 may include an optional step 412, which includes one or more post-processing steps or procedures. In these aspects, optional step 412 may include extruding an inner shaft and / or inner support (i.e., mandrel 16), bonding or otherwise connecting the balloon 12 to the inner shaft (e.g., coupling or positioning the inner balloon wall 42 to the mandrel 16), trimming the balloon catheter 10, assembling or otherwise connecting the balloon catheter 10 to one or more other components (i.e., for delivery and / or expansion of the balloon catheter 10), and / or bonding one or more portions of the balloon catheter 10 (e.g., laser bonding and / or UV manifold bonding one or more portions of the balloon catheter 10, such as the proximal portion and / or distal portion of the balloon catheter 10). Alternatively or additionally, in some aspects, optional step 412 may include checking the pressure of the balloon catheter 10 (e.g., by inflating the balloon catheter 10 to one or more desired pressures to ensure structural consistency and / or stability), applying one or more coatings to one or more portions of the exterior of the balloon catheter 10 (e.g., Glidex on the distal portion of the balloon catheter 10), and / or applying one or more coatings to the exterior of the balloon catheter 10. TM Hydrophilic or Mediglide TM silicone coating), folding the balloon catheter 10, positioning the balloon catheter 10 within a balloon protector, positioning the balloon catheter 10 within a package, and / or sterilizing the balloon catheter 10 (e.g., by exposure to sterilizing heat (e.g., steam or dry heat), radiation (e.g., UV radiation), ethylene oxide gas, vaporized hydrogen peroxide, etc.).

[0047] Various aspects of the medical devices and related methods discussed herein can help provide an ultra-high pressure and / or non-compliant balloon catheter 10, for example, for performing a PCNL procedure. In addition, various aspects of the medical devices and related methods can help provide an outer fiber braid having a variable spacing, which can help provide a high burst strength while also providing a small distal taper and / or a small overall profile. For example, the braid 14 on the balloon 12 can help allow the balloon catheter 10 to have a rated burst pressure of approximately 30 atmospheres or more. In addition, the distal transition region 28 can form a short distal conical section having a taper angle greater than 40 degrees, such as greater than 45 degrees (e.g., approximately 50 degrees). As Figure 2 and Figure 3AAs shown, the cone angle can be twice the angle θ. For example, θ can be greater than 20 degrees, for example, greater than 22.5 degrees (for example, about 25 degrees), so that the cone angle is greater than 40 degrees, for example, greater than 45 degrees (for example, about 50 degrees). The distal transition region 28 can allow the balloon catheter 10 to be adjacent to or otherwise adjacent to one or more objects 40 (i.e., kidney stones) to be positioned, thereby allowing easier and / or safer operation, energy application, removal or other treatment. As described above, the braid 14 can be denser (that is, adjacent fibers 34, 36, 38 can be more closely together on the distal transition region 28 than on the middle portion 10C), which can further increase the rated burst pressure of the balloon catheter 10, because when expanded to a higher pressure, many balloon catheters rupture on one or more distal and / or tapered portions.

[0048] Although the principles of the present disclosure are described herein with reference to illustrative examples of specific applications, it should be understood that the present disclosure is not limited thereto. Those of ordinary skill in the art and those who have received the teachings provided herein will recognize that other modifications, applications, embodiments and alternatives of equivalents all fall within the scope of the features described herein. Therefore, the features protected by the claims should not be considered to be limited by the foregoing description.

Claims

1. A balloon catheter, comprising: An expandable balloon, wherein the expandable balloon comprises a middle portion, a distal waist, and a transition portion between the middle portion and the distal waist, wherein at least a portion of the transition portion has a taper angle of at least 40 degrees; and A braid on the outer surface of the expandable balloon, wherein the braid comprises a plurality of threads, wherein spacing between adjacent threads of the plurality of threads on the distal waist is smaller than spacing between adjacent threads of the plurality of threads on the middle portion, and wherein spacing between adjacent threads of the plurality of threads on the transition portion gradually transitions from spacing between adjacent threads on the middle portion to spacing between adjacent threads on the distal waist on the transition portion.

2. The balloon catheter according to claim 1, wherein: The plurality of wires include a plurality of clockwise wires, a plurality of counterclockwise wires, and a plurality of longitudinal wires, wherein the plurality of clockwise wires, the plurality of counterclockwise wires, and the plurality of longitudinal wires are braided together on an outer surface of the inflatable balloon.

3. The balloon catheter according to claim 2, wherein: On the middle portion, the transition portion and the distal waist, the plurality of threads include an equal number of clockwise threads, counterclockwise threads and longitudinal threads.

4. The balloon catheter according to any one of the preceding claims, further comprising a thermoplastic polyurethane layer formed on at least a portion of the expandable balloon between the expandable balloon and the braid.

5. The balloon catheter according to claim 4, wherein: The thermoplastic polyurethane layer is a first thermoplastic polyurethane layer, and wherein the balloon catheter further includes a second thermoplastic polyurethane layer formed on at least a portion of the braid.

6. The balloon catheter of any of the preceding claims, further comprising a silicon-based lubricious coating on the exterior of the balloon catheter.

7. A balloon catheter according to any one of the preceding claims, wherein: The inflatable balloon includes an inner balloon wall and an outer balloon wall, and wherein the outer balloon wall is configured to be spaced apart from the inner balloon wall at least in the middle portion and the transition portion when the inflatable balloon is inflated.

8. The balloon catheter according to claim 7, further comprising a mandrel, wherein The inner balloon wall is coupled to the mandrel.

9. A balloon catheter according to any one of the preceding claims, wherein: The expandable balloon comprises a diameter of 10 mm, and wherein the transition portion comprises a length of 8.5 mm.

10. A balloon catheter according to any one of the preceding claims, wherein: At least a portion of the transition portion extends from the distal end of the intermediate portion at an angle of 25 degrees.

11. A balloon catheter according to any one of the preceding claims, wherein: The transition portion is a distal transition portion, and wherein the expandable balloon further comprises a proximal waist and a proximal transition portion between the middle portion and the proximal waist.

12. A balloon catheter according to any one of the preceding claims, wherein: The balloon catheter is configured for percutaneous nephrolithotomy or nephrolithotomy such that the distal waist is positioned adjacent to the stone.

13. A balloon catheter according to any one of the preceding claims, wherein: The plurality of threads are fused together over at least a portion of the distal waist portion.

14. A balloon catheter according to any one of the preceding claims, wherein: The plurality of wires are Vectran TM fiber.

15. A balloon catheter according to any one of the preceding claims, wherein: The balloon catheter has a rated burst pressure of at least 30 atmospheres.

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