Reinforced medical balloon

Abstract

A medical device (110) includes an elongate shaft (130) having a distal end region and a balloon (120) coupled to the distal end region, the balloon (120) including a wall, a distal waist portion, a proximal waist portion, and a body portion between the distal waist portion (117) and the proximal waist portion (115). The medical device further includes a first reinforcement region (122a) positioned along the body portion, the first reinforcement region (122a) including a first plurality of filaments (134); and a second reinforcement region (122b) positioned along the body portion, the second reinforcement region (122b) comprising a second plurality of filaments (134). The first reinforcement region (122a) is circumferentially spaced from the second reinforcement region (122b) such that the balloon wall extending between the first and second reinforcement regions is free of filaments. A cutting member (140) may be disposed on each reinforcement region (122a, 122b).

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 342,222, filed on May 16, 2022, entitled "Enhanced Medical Balloon," which is incorporated herein by reference. Technical Field

[0003] The present invention relates to methods and apparatus for performing valvuloplasty More particularly, the present invention relates to methods and apparatus for performing valvuloplasty using a reinforced valvuloplasty balloon, and a reinforced valvuloplasty balloon including one or more cutting members coupled to the valvuloplasty balloon. Background Art

[0004] Heart valve stenosis or calcification is a common manifestation of heart valve disease and can often be a leading indicator for balloon valvuloplasty and / or valve replacement therapy. In some cases, balloon valvuloplasty may help improve the lifestyle of patients with valvular stenosis and may also facilitate successful valve replacement surgery.

[0005] Stenotic or narrowed heart valves can be treated with a variety of relatively non-invasive medical procedures, including percutaneous transluminal balloon valvuloplasty (PTBV), percutaneous transcatheter heart valve replacement (PTVR), atherectomy, and combinations thereof. Valvuloplasty techniques typically involve the use of a balloon catheter that is advanced over a guidewire so that a valvuloplasty balloon is positioned adjacent to the stenotic heart valve. Once positioned in place within the heart valve, the balloon is inflated and dilates the narrowed heart valve.

[0006] In some cases, balloon valvuloplasty may not be sufficient to treat a severely diseased heart valve. In such cases, a percutaneous transcatheter heart valve replacement (PTVR) may be performed to replace a native heart valve with an artificial heart valve. A method of performing a percutaneous transcatheter heart valve replacement may include using a valvuloplasty balloon equipped with one or more cutting members to incise a stenotic heart valve and thereby prepare the native valve tissue for implantation of a replacement heart valve. Accordingly, valvuloplasty balloons equipped with cutting members have been developed in an attempt to enhance heart valve replacement therapy. There is a need for improved valvuloplasty balloons, including cutting valvuloplasty balloons, and improved methods of treating heart valve disease. Summary of the invention

[0007] The present invention provides designs, materials, manufacturing methods, and use alternatives for medical devices. An example medical device includes an elongated shaft having a distal region and a balloon coupled to the distal region, the balloon including a wall, a distal waist, a proximal waist, and a main body portion located between the distal waist and the proximal waist. The medical device also includes a first reinforcement region positioned along the main body portion, the first reinforcement region including a first plurality of filaments; and a second reinforcement region positioned along the main body portion, the second reinforcement region including a second plurality of filaments. In addition, the first reinforcement region is circumferentially spaced from the second reinforcement region such that the balloon wall extending between the first and second reinforcement regions is free of filaments.

[0008] Alternatively or additionally to any of the above embodiments, wherein the balloon wall extending between the first and second reinforced regions has a first elasticity, and wherein the first and second reinforced regions have a second elasticity less than the first elasticity.

[0009] Alternatively or additionally to any of the above embodiments, the balloon is configured to be inflated to a first pressure, wherein the balloon wall without the filaments has a diameter at the first pressure, wherein the first reinforced region has a diameter at the first pressure, and wherein the diameter of the balloon wall without the filaments at the first pressure is greater than the diameter of the first reinforced region.

[0010] Alternatively or additionally to any of the above embodiments, wherein the first plurality of filaments are arranged in a braided formation, and wherein the second plurality of filaments are arranged in a braided formation.

[0011] Alternatively or additionally to any of the above embodiments, wherein each of the first plurality of filaments and the second plurality of filaments comprises a wire.

[0012] Alternatively or additionally to any of the above embodiments, wherein each of the first plurality of filaments and the second plurality of filaments comprises a fiber.

[0013] Alternatively or additionally to any of the above embodiments, wherein the first plurality of filaments are arranged as a first strip of braided filaments extending along the body portion, and wherein the second plurality of filaments are arranged as a second strip of braided filaments extending along the body portion.

[0014] Alternatively or additionally to any of the above embodiments, the first reinforcement region includes a reinforcement component, the reinforcement component comprising a base material, a plurality of filaments attached to the base material, and a polymer coating attached to the plurality of filaments, wherein the reinforcement component is configured to be individually attached to the outer surface of the body.

[0015] Alternatively or additionally to any of the above embodiments, wherein the balloon wall comprises an inner layer having a first hardness and an outer layer having a second hardness greater than the first hardness.

[0016] Alternatively or additionally to any of the above embodiments, wherein the first reinforcement region further comprises a polymer coating disposed along the first plurality of filaments.

[0017] Alternatively or additionally to any of the above embodiments, wherein the first reinforcement region further comprises a cutting member attached thereto.

[0018] Alternatively or additionally to any of the above embodiments, wherein the cutting member comprises a wire having a first region and a second region, and wherein the first region is configured to be attached to the plurality of filaments, and wherein the second region is configured to extend radially away from the first region.

[0019] Alternatively or additionally to any of the above embodiments, wherein one or more of the plurality of filaments is engaged with a portion of the first region of the wire.

[0020] Alternatively or additionally to any of the above embodiments, wherein the cutting member comprises an atherotome.

[0021] An example balloon catheter includes an elongated shaft having a distal region and a balloon attached to the distal region, the balloon including a wall and a plurality of reinforcement regions extending longitudinally along the columnar main body portion of the balloon. In addition, each of the plurality of reinforcement regions includes a mesh material. Additionally, each of the plurality of reinforcement regions is circumferentially spaced apart from each other so that the portion of the balloon wall positioned between any two reinforcement regions is free of filaments.

[0022] Alternatively or additionally to any of the above embodiments, wherein a portion of the balloon wall extending between any two reinforced regions has a first elasticity, and wherein each of the plurality of reinforced regions has a second elasticity less than the first elasticity.

[0023] Alternatively or additionally to any of the above embodiments, wherein the mesh material comprises a plurality of wires.

[0024] Alternatively or additionally to any of the above embodiments, wherein the mesh material comprises a plurality of fibers.

[0025] Alternatively or additionally to any of the above embodiments, wherein at least one of the plurality of reinforcement regions further comprises a cutting member attached thereto.

[0026] An example method of using a balloon catheter includes providing a balloon catheter. The balloon catheter includes a balloon coupled to a distal region, the balloon including a columnar main body portion; a first reinforcement region positioned along the main body portion, the first reinforcement region including a first plurality of filaments; and a second reinforcement region positioned along the main body portion, the second reinforcement region including a second plurality of filaments. Additionally, the first reinforcement region is circumferentially spaced from the second reinforcement region such that a balloon wall extending between the first and second reinforcement regions is free of filaments. The method also includes advancing the balloon catheter to a target site, inflating the balloon, whereby the balloon engages the target site, scaling the balloon, and withdrawing the balloon catheter from the blood vessel.

[0027] The above summary of some embodiments is not intended to describe each disclosed embodiment or every implementation of the present invention. The following figures and detailed description more particularly exemplify these embodiments. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] The present invention may be more fully understood from the following detailed description considered in conjunction with the accompanying drawings, in which:

[0029] Figure 1 showing a perspective view of an example medical balloon;

[0030] Figure 1A showing an exploded view of a portion of an example medical balloon;

[0031] Figure 2 yes Figure 1 Along the middle Figure 1 A cross-sectional view of the medical balloon taken along line 2-2;

[0032] Figure 3 yes Figure 1 Along the middle Figure 1 A cross-sectional view of the medical balloon taken along line 3-3;

[0033] Figure 4 yes Figure 1 Cross-sectional view of a TCM balloon in its expanded configuration;

[0034] Figure 5 yes Figure 1 Cross-sectional view of a traditional Chinese medical balloon in a zoomed configuration;

[0035] Figure 6 is a perspective view of another medical balloon including a cutting member;

[0036] Figure 7 yes Figure 6 Along the middle Figure 6 A cross-sectional view of the medical balloon taken along line 7-7;

[0037] Figure 8 yes Figure 6Along the middle Figure 6 A cross-sectional view of the medical balloon taken along line 8-8;

[0038] Fig. 9 is a cross-sectional view of another example medical balloon including a cutting member;

[0039] Fig.10 is a perspective view of another example medical balloon including a cutting member;

[0040] Fig.11 yes Fig.10 Along the middle Fig.10 A cross-sectional view of the medical balloon taken along line 11-11;

[0041] Fig.12 is a perspective view of another example medical balloon including a plurality of cutting members;

[0042] Fig.13 yes Fig.12 Along the middle Fig.12 A cross-sectional view of the medical balloon taken along line 13-13;

[0043] Fig.14 Show Figures 12 to 13 A portion of a medical balloon is shown in FIG. DETAILED DESCRIPTION

[0044] The following description should be read with reference to the drawings, wherein like reference numerals refer to like elements throughout the several views.The detailed description and drawings illustrate example embodiments of the claimed invention.

[0045] As discussed above, medical balloons can be used in a variety of medical treatments. For example, in valvuloplasty, a valvuloplasty balloon can be used to dilate a diseased heart valve. A cutting balloon can also be used to prepare (e.g., cut open) a stenotic heart valve in order to implant a replacement heart valve.

[0046] The valvuloplasty balloon can be delivered to the target site by advancing the balloon catheter over a guidewire to the target site. In some cases, the path to the target site can be tortuous and / or narrow. Upon reaching the site, the valvuloplasty balloon can be expanded by injecting a fluid into the interior of the balloon. Expanding the valvuloplasty balloon can radially expand the narrowed heart valve so that normal blood flow can be restored through the valve.

[0047] In some cases, it may be desirable to utilize a high pressure valvuloplasty balloon when treating a particular target site (e.g., a stenotic heart valve). In order to achieve the desired pressure or force on the tissue at the target site, the valvuloplasty balloon may be constructed with a thicker balloon wall. However, the thicker balloon wall may increase the profile (e.g., outer diameter) of the balloon when it is in a scaled configuration. Minimizing the profile of the balloon in the scaled configuration is important because the profile affects the ease and ability of the valvuloplasty balloon to pass through a guide catheter through the coronary arteries and across the narrowed heart valve. In order to minimize the outer diameter of the balloon in its scaled condition, it may be desirable to control the folding / refolding operation of the valvuloplasty balloon. Examples disclosed herein may include a valvuloplasty balloon comprising a reinforcing segment designed to control the folding operation of the balloon while also providing an anchoring component for attaching one or more cutting members.

[0048] Figure 1 An example balloon catheter 10 is shown. The balloon catheter 10 may include an expandable medical balloon 20 mounted to the distal end of an outer catheter shaft 30. The medical balloon 20 may be designed for various medical procedures, including valvuloplasty. The catheter shaft 30 may extend from a manifold assembly (not shown) positioned at the proximal end of the catheter shaft 30. The balloon 20 may also include a body portion 12, a proximal tapered portion 14, a distal tapered portion 16, a proximal waist portion 15, and a distal waist portion 17. The body portion 12 may be positioned between the proximal tapered portion 14 and the distal tapered portion 16, wherein the proximal waist portion 15 extends proximally of the proximal tapered portion 14, and the distal waist portion 17 extends distally of the distal tapered portion 16. The balloon 20 may be fixed to the outer catheter shaft 30 at the proximal waist portion 15. It should be understood that the inner shaft 32 may extend within the outer catheter shaft 30, through the interior cavity of the balloon 20 and fixed to the distal waist 17.

[0049] The inner shaft 32 may include an inner lumen. In at least some embodiments, the inner lumen of the inner shaft 32 may be a guidewire lumen. Thus, the catheter 10 may be advanced to a desired position over a guidewire. The guidewire lumen may extend substantially along the entire length of the catheter shaft 30, such that the catheter 10 is similar to a conventional "on-the-wire" catheter. Alternatively, the guidewire lumen may extend only along a portion of the shaft 30, such that the catheter 10 is similar to a "single operator exchange" catheter.

[0050] In addition, the outer shaft 30 can also include an inflation lumen that can be used, for example, to deliver an inflation medium to and from the balloon 20. When the outer shaft 30 is disposed on the inner shaft 32, the inflation lumen can be defined in a space between an outer surface of the inner shaft 32 and an inner surface of the outer shaft 30.

[0051] As will be discussed in detail below, balloon 20 may include a balloon wall composed of one or more layers, wherein each layer may be composed of a different balloon material. Figure 3 Detailed views of the balloon wall 24 may include an inner layer and an outer layer, wherein the inner layer is composed of a material of lower hardness (e.g., softer) than the outer layer. This two-layer construction may be referred to as a double-layer balloon base layer. In addition, the inner layer and the outer layer of the double-layer balloon wall 24 may be co-extruded during the manufacturing process of the balloon. Typical balloon materials may include polymeric materials, some examples of which are listed herein.

[0052] In addition, if Figure 1 As shown, balloon 20 may include one, two, three, four, five, six, or more reinforcement portions arranged circumferentially about the longitudinal axis of balloon 20. Figure 1 The balloon 20 shown includes three reinforcement parts 22a, 22b, 22c. The reinforcement part 22c is Figure 1 Hidden in Figures 3 to 5 Shown in.

[0053] In some examples, the reinforcing portions 22a, 22b, 22c may include one or more interwoven (e.g., braided, woven, or knitted) filaments 34 that are attached to the outer surface of the balloon 20. The filaments 34 may be made of a variety of materials. For example, the filaments 34 may be made of silk, Or other suitable materials. In other examples, the reinforcing portions 22a, 22b, 22c may include a continuous, flexible strip of material attached to the balloon 20. However, in other examples, the reinforcing portions 22a, 22b, 22c may include a polyimide strip, a liquid crystal polymer, or other similar materials.

[0054] In some examples, Figure 1 Each reinforcement portion 22a, 22b, 22c in the balloon 20 may include one or more braided or interwoven filaments 34 disposed along the outer surface of the balloon 20. In some examples, the filaments 34 may be braided, wound, wrapped, woven, etc. in various forms along each reinforcement portion 22a, 22b, 22c of the balloon 20. For example, the filaments 34 may be arranged in a manner such that: Figure 1 The morphology shown is extruded directly onto the outer surface of the balloon 20. However, in other examples, the filaments 34 may be extruded with the balloon material so that the filaments 34 are partially embedded in the wall 24 of the balloon 20. However, in other examples, the filaments 34 may be extruded with the balloon material so that the filaments 34 are completely embedded in the wall 24 of the balloon 20. Alternatively, it should be understood that the filaments 34 may be adhesively bonded to the outer surface of the balloon 20. The adhesive may include a thermosetting adhesive that cures via a chemical reaction or radiation. In some examples, the polymer coating 26 ( Figure 3) may be applied to the braided filaments 34. The polymer coating may encapsulate the braided filaments 34 along each reinforcement portion 22a, 22b, 22c.

[0055] In other examples, each reinforcement portion 22a, 22b, 22c may be constructed as a separate component, such as a textile strip, which is then attached to the outer surface of the balloon 20 in a subsequent manufacturing step. Figure 1A The reinforcement portions 22a, 22b, 22c are shown to be formed as preformed individual components that include a base material (eg, a polymer tie layer), braided or interwoven filaments 34, and a top coating material 26 (eg, a compliant polymer material). Figure 1A The individual components are shown to be preformed to include braided filaments 34 sandwiched between a base material 36 (e.g., a polymer tie layer) and a polymer coating 26. Once the individual components are preformed, they can be heat bonded to the outer surface of the balloon 20 in a manufacturing step after the balloon 20 is extruded and blown.

[0056] In some examples, forming Figure 1A The process of the separate component may include a lamination process. For example, the braided filaments 34 may be laminated between a base material (e.g., a polymer tie layer) and a top coating material 26 (e.g., a compliant polymer material) to form a separate component, which may then be attached to the outer surface of the balloon 20. In some cases, the separate component may be considered a textile strip, such as, for example, a laminated textile strip.

[0057] It should be understood that the base layer 36 can be composed of the same material as the material forming the balloon 20 or a material compatible with the material forming the balloon 20, thereby allowing the base layer 36 and the outer surface of the balloon 20 to melt (e.g., fuse, bond) together during thermal welding. As used herein, thermal bonding refers to melting a material or a portion thereof by applying heat, laser, welding, or some combination thereof to obtain mixing or bonding of the materials at the material interface.

[0058] Figure 2 It is along Figure 1 A cross-sectional view of the balloon 20 taken along line 2-2 of FIG. As described herein, Figure 2 Reinforced portions 22a, 22b are shown extending longitudinally along the main body portion 12 of the balloon 20 (reinforced portion 22c is hidden from view). Figure 2 The detailed view of FIG. 2 shows filaments 34 disposed along the outer surface of the balloon wall 24. As discussed herein, the braided or interwoven filaments 34 may be disposed directly on the outer surface of the balloon wall 24 (e.g., the braided or interwoven filaments 34 may be extruded directly onto the outer surface of the balloon wall 24). However, in other examples, the filaments 34 may be partially or completely embedded in the balloon wall 24 (via an extrusion process or other suitable manufacturing method).

[0059] Figure 2 It is also shown that the filaments 34 can be fully or partially covered by the polymer coating 26. In some examples, the polymer coating 26 can extend continuously (e.g., uninterrupted) along the entire length of the reinforcement portions 22a, 22b, 22c, thereby completely encapsulating all of the braided or interwoven filaments 34 between the balloon wall 24 and the polymer coating 26.

[0060] Figure 3 Shown along Figure 1 A cross-sectional view of the balloon 20 taken along line 3-3. Figure 3 Three reinforcement portions 22a, 22b, 22c are shown arranged circumferentially about the longitudinal axis 50 of the balloon 20. Figure 3 The three reinforcement portions 22a, 22b, 22c are shown to be equally spaced about the longitudinal axis 50 of the balloon 20. However, in other examples, the three reinforcement portions 22a, 22b, 22c may be unequally spaced about the longitudinal axis 50 of the balloon 20. As discussed herein, the balloon 20 may include one, two, three, four, five, six, or more reinforcement portions (e.g., 22a, 22b, 22c) arranged about the longitudinal axis 50 of the balloon 20.

[0061] Figure 3 Also shown are braided or interwoven filaments 34 of each reinforcement portion 22a, 22b, 22c disposed along the outer surface of the wall 24 of the balloon 20. Figure 3 It will be appreciated that a circumferential portion of the balloon wall 24 extends between each reinforcement portion 22a, 22b, 22c, thereby establishing discrete areas of continuous balloon wall 24 that are free of filaments 34. Additionally, Figure 3 The filaments 34 of each reinforcement portion 22a, 22b, 22c are shown to include a polymer coating 26 disposed thereon. As discussed herein, the polymer coating 26 can completely encapsulate the filaments 34. In other words, Figure 3 The braided or interwoven filaments 34 of each reinforcement portion 22a , 22b , 22c are shown to be completely encapsulated between the polymer coating 26 and the balloon wall 24 .

[0062] Figure 4 A cross-sectional view of the balloon 20 is shown in an inflated configuration. Figure 4It will be appreciated that when the balloon 20 is inflated, the portions 28a, 28b, 28c of the balloon wall 24 that are free of the filaments 34 (e.g., portions of the balloon wall 24 that extend between the reinforcement portions 22a, 22b, 22c) may expand (e.g., stretch, dilate, etc.) to a greater radial extent than the portions 22a, 22b, 22c of the balloon wall 24 that are reinforced / reinforced by the filaments 34. In other words, during inflation of the balloon 20, the reinforcement portions 22a, 22b, 22c may function to limit radial expansion of the portions 22a, 22b, 22c of the balloon wall 24 that are reinforced / reinforced by the braided or interwoven filaments 34, thereby allowing the portions 28a, 28b, 28c of the balloon wall 24 that are not reinforced / reinforced by the braided or interwoven filaments 34 to expand beyond the radial extent of the portions 22a, 22b, 22c of the balloon 20 that are reinforced / reinforced by the braided or interwoven filaments 34.

[0063] Figure 5 A cross-sectional view of the balloon 20 in a collapsed configuration is shown. Figure 4 As shown in FIG. 1 , the inflation medium may be drawn through the outer shaft 30, which may generate a negative pressure (i.e., a vacuum) that pulls the inner surface of the balloon 20 radially inward toward the longitudinal axis 50. It should be appreciated that because the reinforced portions 22a, 22b, 22c are relatively stiff compared to the portions 28a, 28b, 28c of the balloon wall 24 extending between the reinforced portions 22a, 22b, 22c (e.g., the portions 28a, 28b, 28c of the balloon wall 24 without the reinforcing / enhancing filaments 34), the portions 28a, 28b, 28c of the balloon wall extending between the reinforced portions 22a, 22b, 22c will more easily collapse inward toward the longitudinal axis 50 of the balloon. Figure 5 As shown, the reinforcement portions 22a, 22b, 22c are relatively stiff and thus support the balloon wall 24 disposed therebetween. Therefore, when the balloon 20 is scaled, the circumferential portions 28a, 28b, 28c of the balloon wall 24 extending between the reinforcement portions 22a, 22b, 22c may collapse more easily. It should also be understood that the resistance of the reinforcement portions 22a, 22b, 22c of the balloon 20 against collapse may cause the balloon 20 to refold symmetrically during scaling compared to other portions of the balloon 20. This symmetrical refolding of the balloon 20 may result in a smaller folding profile of the scaled balloon 20, which may enable the balloon to be more easily withdrawn into a guide catheter for inserting the balloon 20 into the body.

[0064] Figure 6 Another example balloon catheter 110 is shown. The example balloon 120 can be similar in form and function to the balloon catheter 10 discussed herein. The balloon catheter 110 can include an expandable medical balloon 120 mounted to the distal end of an outer shaft 130. The balloon 120 can be similar in form and function to the balloon 20 described herein. For example, the wall 124 ( Figure 7 Detailed views of the embodiment of the present invention may include a dual-layer structure including an inner layer and an outer layer, whereby the inner layer is composed of a lower hardness (e.g., softer) material than the outer layer. It is contemplated that in other cases, the outer layer may be composed of a lower hardness (e.g., softer) material than the inner layer, if desired.

[0065] The medical balloon 120 can be designed for use in a variety of medical procedures, including valvuloplasty. The outer shaft 130 can extend from a manifold assembly (not shown) positioned at the proximal end of the catheter shaft 130. The balloon 120 can also include a body portion 112, a proximal tapered portion 114, a distal tapered portion 116, a proximal waist portion 115, and a distal waist portion 117. The body portion 112 can be positioned between the proximal tapered portion 114 and the distal tapered portion 116, wherein the proximal waist portion 115 extends proximally of the proximal tapered portion 114, and the distal waist portion 117 extends distally of the distal tapered portion 116. The balloon 120 can be fixed to the outer catheter shaft 30 at the proximal waist portion 115. It should be understood that the inner shaft (not shown) can extend within the outer catheter shaft 130, through the interior cavity of the balloon 120 and fixed to the distal waist 117. Similar to that discussed with respect to balloon catheter 10, an inflation lumen can be defined in the space between the outer surface of the inner shaft and the inner surface of outer shaft 130. The inflation lumen can be used to deliver inflation media to and from balloon 120.

[0066] Similar to those discussed with respect to balloon 20, Figure 6 The balloon 120 shown in can include one, two, three, four, five, six or more reinforcement portions, whereby the reinforcement portions are arranged circumferentially around the longitudinal axis of the balloon 120. For example, Figure 6 The balloon 120 shown includes three reinforcement parts 122a, 122b, and 122c. Figure 6 Hidden in Figure 8 Shown in.

[0067] Similar to the reinforcement portions 22a, 22b, 22c discussed herein, each of the reinforcement portions 122a, 122b, 122c of the balloon 120 may include one or more interwoven (e.g., braided, woven, or knitted) filaments 134 disposed along the outer surface of the balloon 120. The filaments 134 may be made of a variety of materials. For example, the filaments 134 may be made of silk, or other suitable materials. In addition, the braided or interwoven filaments 134 of each of the reinforcement portions 122a, 122b, 122c may be disposed along the outer surface of the balloon 120 in a manner similar to that described with respect to the reinforcement portions 22a, 22b, 22c of the balloon 20. Alternatively, the polymer coating 126 ( Figure 7-8As shown) can be applied to the filaments 134 of the reinforced portions 122a, 122b, 122c of the balloon 120.

[0068] Figure 6 It is also shown that the medical balloon 120 may include a cutting member 140 coupled to each of the reinforcement portions 122a, 122b, 122c. The cutting member 140 can be used to cut or incise the tissue of a diseased heart valve during valvuloplasty. In some examples, the cutting member 140 may include an elongated filament, such as a wire or fiber. The cutting member 140 may be formed of a variety of materials, including polymers or metallic materials. In some cases, the cutting member 140 may extend along the balloon 120 and be attached to the balloon 120 via engagement with the interwoven filaments 134 of the reinforcement portions 122a, 122b, 122c.

[0069] Figure 7 Shown along Figure 6 A cross-sectional view of the balloon 120 taken along line 7-7. Figure 7 Each of the cutting members 140 of the reinforcement portions 122a, 122b, 122c shown can form a completely longitudinally extending loop, whereby a first portion of the cutting member 140 can pass through or under the interwoven filaments 134 of each reinforcement portion 122a, 122b, 122c, respectively, while a second portion of the cutting member 140 is positioned radially outward of the reinforcement portions 122a, 122b, 122c. In some cases, the first portion of the cutting member 140 can be interwoven through the filaments 134 of one of the reinforcement portions 122a, 122b, 122c. It should be understood that the engagement of the cutting member 140 with the interwoven filaments 134 can anchor (e.g., fixedly attach) the cutting member 140 to each of the reinforcement portions 122a, 122b, 122c of the balloon 120. For example, it will be appreciated that one or more of the filaments 134 may be passed over and / or under the cutting member 140 to fixedly attach the cutting member 140 to each reinforcement portion 122a , 122b , 122c of the balloon 120 .

[0070] Figure 8 Shown along Figure 6 A cross-sectional view of the balloon 120 taken along line 8-8. Figure 8 Three reinforcement portions 122a, 122b, 122c are shown arranged circumferentially about the longitudinal axis 50 of the balloon 120. Figure 8Three reinforcement portions 122a, 122b, 122c are shown spaced equidistantly about the longitudinal axis 50 of the balloon 120. However, in other examples, the three reinforcement portions 122a, 122b, 122c may be unequally spaced about the longitudinal axis 50 of the balloon 120. As discussed herein, the balloon 120 may include one, two, three, four, five, six, or more reinforcement portions (e.g., 122a, 122b, 122c) arranged about the longitudinal axis 50 of the balloon 20.

[0071] Figure 8 Also shown are braided or interwoven filaments 134 of each of the reinforcement portions 122a, 122b, 122c disposed along the outer surface of the wall 124 of the balloon 120. Figure 8 It will be appreciated that a circumferential portion of the balloon wall 124 extends between each of the reinforcement portions 122a, 122b, 122c, thereby establishing discrete areas of continuous balloon wall 124 that are free of filaments 134. Additionally, Figure 8 The braided or interwoven filaments 134 of each reinforcement portion 122a, 122b, 122c are shown to include a polymer coating 126 disposed thereon. Thus, the polymer coating 126 can completely encapsulate the braided filaments 134 between the polymer coating 126 and the balloon wall 124. In other words, Figure 8 The braided filaments 134 of each reinforcement portion 122a , 122b , 122c are shown to be completely encapsulated between the polymer coating 126 and the balloon wall 124 .

[0072] Additionally, Figure 8 Also shown is a cutting member 140 fixedly attached to each of the reinforcement portions 122a, 122b, 122c. As described herein, Figure 8 Also shown is a portion of the cutting element 140 positioned within or below the interwoven filaments 134 of each of the reinforcement portions 122a, 122b, 122c. As described herein, Figure 8 Each of the cutting elements 140 shown may include a portion attached to the balloon 120 via individual filaments 134 passing above and / or below the cutting element 140, thereby fixedly attaching the cutting element 140 to each of the reinforced portions 122a, 122b, 122c of the balloon 120.

[0073] according to Figure 8 It is also understood that a portion of the cutting element 140 may be distal to the polymer coating 126 (e.g., radially outward), and the polymer coating 126 may encapsulate both the braided or interwoven filaments 134 and the portion of the cutting element 140 attached to the braided or interwoven filaments 134. For example, by referring back to Figure 7It will be appreciated that the annular portion of the cutting element 140 that does not pass through or under the braided or interwoven filaments 134 of the reinforcing portions 122a, 122b, 122c may extend radially away from the filaments 134 and through the polymer coating 126 to complete the annular form of the cutting element 140, such as Figure 7 Therefore, return to the reference Figure 8 , it should be understood that a portion of the cutting element 140 may be exposed exteriorly and / or radially away from the outer surface of the polymer coating 126 of each of the reinforcement portions 122a, 122b, 122c.

[0074] Fig. 9 A cross-sectional view of another example medical balloon 220 is shown. Fig. 9 The illustrated balloon 220 may be similar in form and function to Figure 7 The balloon 120. For example, Fig. 9 A balloon 220 is shown including a cutting element 240 attached to a reinforcing portion 222a, similar to Figure 7 Attachment of cutting element 140 to reinforcement portion 122a is shown. Cutting member 140 can be used to cut or incise tissue of a diseased heart valve during valvuloplasty. In some cases, if desired, cutting member 140 can be an elongated filament, such as a wire or fiber.

[0075] However, with Figure 7 different, Fig. 9 The cutting element 240 of the balloon 220 shown may not form a complete longitudinal ring along the length of the reinforcement portion 222a. Fig. 9 The detailed view of FIG. 2 shows that the cutting member 240 may include a first end portion 242 and a second end portion 243. Additionally, Fig. 9 It is shown that the first end portion 242 of the cutting element 240 can be attached to the braided or interwoven filaments 234 at the first end region of the balloon body 212, and the second end portion 243 of the cutting element 240 can be attached to the braided or interwoven filaments 234 at the second end region of the balloon body 212. In some cases, the first end portion 242 of the cutting element 240 can be embedded in the reinforcement portion 222a, and the second end portion 243 of the cutting element 240 can be embedded in the reinforcement portion 222a, while the middle portion of the cutting member 240 is positioned radially outside the reinforcement portion 222a.

[0076] It should be understood that the first end portion 242 and the second end portion 243 of the cutting element 240 can be similar to the above-mentioned Figure 7The cutting element 140 is attached to the braided or interwoven filaments 234 in the manner described above for attachment to the braided or interwoven filaments 134. For example, one or more of the filaments 234 may pass over and / or under both the first end portion 242 and the second end portion 243 of each of the cutting elements 240, thereby securing each of the cutting elements 240 to each of the reinforcement portions 222a, 222b, 222c of the balloon 220. Fig. 9 The detailed view of FIG. 2 also shows that polymer coating 226 encapsulates filament 234 , first end portion 242 of cutting element 240 , and second end portion 243 of cutting element 240 .

[0077] Fig.10 Another example medical balloon 320 is shown. Fig.10 The balloon 320 shown may be similar in form and function to other medical balloons described herein. For example, the wall 324 ( Figure 7 Detailed views of the embodiment of the present invention (as shown in FIG. 1 ) may include a dual-layer construction including an inner layer and an outer layer, the inner layer being composed of a lower hardness (e.g., softer) material than the outer layer. It is contemplated that in other cases, the outer layer may be composed of a lower hardness (e.g., softer) material than the inner layer, if desired.

[0078] In addition, the outer shaft 330 can extend from a manifold assembly (not shown) positioned at the proximal end of the outer shaft 330. The balloon 320 can include a body portion 312, a proximal tapered portion 314, a distal tapered portion 316, a proximal waist portion 315, and a distal waist portion 317. The balloon 320 can be secured to the outer catheter shaft 330 at the proximal waist portion 315. In addition, it should be understood that the inner shaft (not shown) can extend within the outer catheter shaft 330, through the interior cavity of the balloon 320 and be secured to the distal waist 317. Similar to what was discussed with respect to the balloon catheter 10, an inflation lumen can be defined in the space between the outer surface of the inner shaft and the inner surface of the outer shaft 330. The inflation lumen can be used to deliver an inflation medium to and from the balloon 320.

[0079] also, Fig.10 The balloon 320 may include a first reinforcement portion 322a positioned along the distal region of the main body portion 312 and a second reinforcement portion 322b positioned along the proximal region of the main body portion 312. Additionally, each of the first reinforcement portion 322a and the second reinforcement portion 322b may include a plurality of braided or interwoven filaments 334 extending circumferentially around the outer surface of the balloon 320. The filaments 334 may be similar in form and function to other filaments disclosed herein. For example, the filaments 334 may be made of silk, or other suitable materials. In addition, the braided or interwoven filaments 334 of each of the reinforcement portions 322a, 322b may be disposed along the outer surface of the balloon 320 in a manner similar to that described herein with respect to the reinforcement portions 22a, 22b, 22c of the balloon 20. Alternatively, the polymer coating 326 ( Fig.11 ) can be applied to the filaments 334 of the reinforcing portions 322a, 322b of the balloon 320. Fig.10 Also shown is that the balloon 320 can include one or more cutting members 340 attached to the reinforcement portions 322a, 322b. The cutting members 340 can be used to cut or incise the tissue of a diseased heart valve during a valvuloplasty procedure.

[0080] Fig.11 The cutting member 340 is shown to be similar in form and function to the Fig. 9 The cutting member 240. For example, Fig.11 The detailed view of FIG. 3 shows that the cutting member 340 may include a first end portion 342 and a second end portion 343. Additionally, Fig.11 The first end portion 342 of the cutting element 340 is shown to be attached to the braided filament 334 at the reinforcement portion 322a, and the second end portion 343 of the cutting element 340 is attached to the braided filament 334 at the reinforcement portion 322b. It should be understood that the first end portion 342 and the second end portion 343 of the cutting element 340 can be similar to the above description of the braided filament 334. Fig. 9 The cutting element 240 is attached to the braided or interwoven filaments 234 in the manner described above, and is attached to the braided or interwoven filaments 334 of each of the reinforcement portions 322a, 322b. For example, one or more of the filaments 334 may pass over and / or under both the first end region 342 and the second end region 343 of each of the cutting elements 340, thereby securing each of the cutting elements 340 to each of the reinforcement portions 322a, 322b of the balloon 320. Fig.11 The detailed view of also shows that polymer coating 326 encapsulates filament 334 , first end portion 342 of cutting element 340 , and second end portion 343 of cutting element 340 .

[0081] according to Figures 10 to 11 It will be appreciated that while the first end portion 342 and the second end portion 343 of each of the cutting elements 340 are attached to the reinforcement portions 322a, 322b of the balloon 320 (e.g., engaged with the braided fibers 334 and covered by the polymer coating 326), the remainder of each of the cutting elements 340 may remain unattached to the outer surface of the balloon 320 and extend outwardly therefrom. For example, Fig.11A portion of the cutting element 340 is shown to be radially away from the outer surface of the balloon 320. In some cases, a first end portion 342 of the cutting element 340 can be embedded in the reinforcement portion 322a, and a second end portion 342 of the cutting element 340 can be embedded in the reinforcement portion 322a, while the middle portion of the cutting member 340 is positioned radially outside the reinforcement portion 322a.

[0082] Fig.12 A perspective view of another example medical balloon 420 is shown. Fig.12 The balloon 420 shown may be similar in form and function to other medical balloons described herein. For example, the wall 424 ( Fig.13 Detailed views of the embodiment of the present invention (as shown in FIG. 1 ) may include a dual-layer construction including an inner layer and an outer layer, the inner layer being composed of a lower hardness (e.g., softer) material than the outer layer. It is contemplated that in other cases, the outer layer may be composed of a lower hardness (e.g., softer) material than the inner layer, if desired.

[0083] In addition, the outer shaft 430 can extend from a manifold assembly (not shown) positioned at the proximal end of the outer shaft 430. The balloon 420 can include a body portion 412, a proximal tapered portion 414, a distal tapered portion 416, a proximal waist portion 415, and a distal waist portion 417. The balloon 420 can be secured to the outer catheter shaft 430 at the proximal waist portion 415. In addition, it should be understood that an inner shaft (not shown) can extend within the outer catheter shaft 430, through the interior cavity of the balloon 420 and be secured to the distal waist 417. Similar to what was discussed with respect to the balloon catheter 10, an inflation lumen can be defined in the space between the outer surface of the inner shaft and the inner surface of the outer shaft 430. The inflation lumen can be used to deliver an inflation medium to and from the balloon 420.

[0084] Fig.12 It is also shown that the balloon 420 may include one or more cutting members (e.g., blades, microsurgical blades, arteriotomies) 446a, 446b, 446c, 446d disposed along the outer surface of the balloon 420. The cutting members 446a, 446b, 446c, 446d may be formed of a variety of materials, including polymeric materials (including those listed herein), metals, and combinations thereof. In addition, each of the cutting members 446a, 446b, 446c, 446d may be segmented, whereby each blade includes one or more incisions and / or regions of increased flexibility along its length. It should be understood that the balloon 420 may be inflated during balloon valvuloplasty to dilate a stenotic heart valve. In some cases, the cutting members 446a, 446b, 446c, 446d may be designed to incise or cut a stenotic heart valve as a pre-dilation step for balloon valvuloplasty.

[0085] The cutting members 446a, 446b, 446c, 446d can vary in number, location, and arrangement about the balloon 420. For example, the balloon 420 can include one, two, three, four, five, six, or more cutting members 446a, 446b, 446c, 446d disposed anywhere along the balloon 420 in a regular, irregular, or any other suitable pattern.

[0086] Fig.12 It is shown that the cutting members 446a, 446b, 446c, 446d can be arranged in series along the outer surface of the balloon 420. In other words, Fig.12 The cutting members 446a, 446b, 446c, 446d are shown to be longitudinally aligned in a spaced-apart manner along the outer surface of the balloon 420. It should be understood that Fig.12 The illustrated arrangement of cutting members 446a, 446b, 446c, 446d can increase the flexibility of balloon 420 by dividing what would otherwise be a single cutting member into multiple portions or segments. Thus, the segmented cutting members 446a, 446b, 446c, 446d may be more adaptable to bending or flexing of balloon 420 due to their reduced length. For example, increasing the flexibility of balloon 420 can improve the ability of balloon 420 to treat a variety of diseased heart valves, some of which may not be easily treated by other less flexible cutting balloons. It should be appreciated that the precise arrangement of cutting members 446a, 446b, 446c, 446d may include, in addition to Fig.12 Arrangements Other Than Shown. For example, the cutting members 446a, 446b, 446c, 446d can have an arrangement in which one or more of the cutting members 446a, 446b, 446c, 446d are longitudinally and / or radially offset from each other.

[0087] If related to Figures 13 to 14 As further discussed, each cutting member 446a, 446b, 446c, 446d can be secured to the outer surface of the balloon 420 by a securing member 440. The securing member 440 can include a wire, a cable, a fiber, a strap, etc. The securing member 440 can include a first end attached along a distal region of the balloon 420 and a second end attached along a proximal region of the balloon 420.

[0088] Additionally, Fig.12It is shown that the fixing member 440 can pass through the body of each cutting member 446a, 446b, 446c, 446d and can be fixed to the balloon 420 along a plurality of fixing regions 422a, 422b, 422c, 422d, 422e located in the spaces / gaps between adjacent cutting members 446a, 446b, 446c, 446d. Thus, in some cases, the fixing regions can alternate with the cutting members along the length of the balloon 420. A detailed description of the cutting members 446a, 446b, 446c, 446d, the fixing member 440, and the fixing regions 422a, 422b, 422c, 422d, 422e is set forth below.

[0089] Fig.13 Shown along Fig.12 A cross-sectional view of the balloon 420 taken along line 13-13. Fig.11 Similar to the attachment method described, Fig.13 The detailed view of FIG. 4 shows that the fixing member 440 may include a first end portion 442 and a second end portion 443. Additionally, Fig.13 A first end portion 442 of the securing member 440 is shown to be attachable to the plurality of braided or interwoven filaments 434 of the securing region 422a, and a second end portion 443 of the securing member 440 is shown to be attachable to the plurality of braided or interwoven filaments 434 of the securing region 422e.

[0090] As discussed herein, it should also be understood that Fig.13 The filaments 434 of each of the fixed regions 422a, 422b, 422c, 422d, 422e shown in FIG. 4 can be similar in form and function to other filaments disclosed herein. For example, the filaments 434 can be made of silk, or other suitable materials. Fig.13 The interwoven filaments 434 of each fixing portion 422a, 422b, 422c, 422d, 422e shown in the figure can be disposed on the outer surface of the balloon 420 in a manner similar to that described herein with respect to the reinforcing portions 22a, 22b of the balloon 20 described herein. Fig.13 As shown in the detailed view of , a polymer coating 426 may be applied to the braided or interwoven filaments 434 of each fixation region 422a , 422b , 422c , 422d , 422e of the balloon 420 .

[0091] As discussed in this article, Figures 13 to 14 The fixing member 440 is shown to pass through the body of each cutting member 446a, 446b, 446c, 446d and can be fixed to the balloon 420 along the fixing area 422a, 422b, 422c, 422d, 422e located in the space / gap between adjacent cutting members. Fig.14The fixing member 440 is shown extending through the hole 452 of the cutting member 446b. It should be understood that the hole 452 can extend along the longitudinal extent of the cutting member 446b from the distal end of the cutting member 446b to the proximal end of the cutting member 446b. In addition, Fig.14 It is shown that the fixing member 440 can be attached to the balloon 420 at the fixing area 422b (located distally of the cutting member 446b) and also at the fixing area 422c (located proximal to the cutting member 446b). It should be understood that the fixing member 440 can be designed to exert a radial downward force on the cutting member 446b, thereby fixing the cutting member 446b along the outer surface of the balloon 420.

[0092] It should be understood that the fixation member 440 can be attached to the balloon 420 at each fixation region 422a, 422b, 422c, 422d, 422e via engagement with the braided or interwoven filaments 434 of each fixation region 422a, 422b, 422c, 422d, 422e. The fixation member 440 can engage the braided or interwoven filaments 434 in a manner similar to that described with respect to engagement of other cutting elements with the braided or interwoven filaments described herein. For example, at each fixation region 422a, 422b, 422c, 422d, 422e, one or more of the filaments 434 can pass over and / or under the fixation member 440, thereby attaching the fixation member 440 to the balloon 420 at each fixation region 422a, 422b, 422c, 422d, 422e. As discussed herein, the polymer coating 426 can encapsulate the braided or interwoven fibers 434 and the portions of the cutting member 440 that extend along each of the securing regions 422a, 422b, 422c, 422d, 422e.

[0093] Additionally, it should be understood that in some alternative examples, one or more of the cutting elements 140, 240, 340 of the balloons 120, 220, 320 may include an RF ablation wire. For example, the cutting elements 140, 240, 340 may be electrically coupled to an energy source located outside the patient's body. Furthermore, the cutting elements 140, 240, 340 of the balloons 120, 220, 320 may include one or more electrodes designed to deliver energy (e.g., radiofrequency energy) to ablate a target tissue site.

[0094] Additionally, it should be understood that in some other alternative examples, the balloon catheter disclosed herein may include one or more components that can be used with cryotherapy treatment. For example, one or more of the balloons 120, 220, 320 disclosed herein may be designed to be inflated with a cooling fluid (i.e., a coolant). In addition, inflating and cooling the balloons 120, 220, 320 with a cooling fluid (i.e., a coolant) may result in the formation of selectively hardened portions along the balloons 120, 220, 320 and / or the hardening of the cutting elements 140, 240, 340 attached to the balloons 120, 220, 320. The hardened portion may increase the amount of expansion force that may be generated by the balloons 120, 220, 320 and / or the cutting elements 140, 240, 340 during the expansion of the balloons 120, 220, 320. The increased expansion force may allow the balloons 120, 220, 320 to effectively expand or cut open the diseased heart valve.

[0095] Example polymers for making the medical balloons 20, 120, 220, 320, 420 and various components of the balloons 20, 120, 220, 320, 420 disclosed herein include polymers such as polyethylene terephthalate (PET), polyetherimide (PEI), polyethylene (PE), etc. Some other examples of suitable polymers including lubricating polymers may include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM), polybutylene terephthalate (PBT), polyether block esters, polyurethanes, polypropylene (PP), polyvinyl chloride (PVC), polyether esters (e.g., polyether ester elastomers such as those available from DSM Engineering Plastics). ), polyesters (e.g., polyester elastomers such as those commercially available from DuPont ), polyamides (e.g., available from Bayer or available from Elf Atto Chemicals ), elastomeric polyamides, block polyamide / ethers, polyether block amides (e.g., PEBA, available under the trade name purchased), silicone, High density polyethylene, Low-density polyethylene, linear low-density polyethylene (e.g. ), polyetheretherketone (PEEK), polyimide (PI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), polysulfone, nylon, perfluoro(propyl vinyl ether) (PFA), other suitable materials or mixtures, combinations, copolymers, polymer / metal composites, etc. thereof. In some embodiments, it may be desirable to use a high modulus or generally harder material to reduce balloon elongation. The above list of materials includes some examples of higher modulus materials. Some other examples of harder materials include polymers mixed with liquid crystal polymers (LCP) and the materials listed above. For example, the mixture can contain up to about 5% LCP.

[0096] It should be understood that the present invention is merely illustrative in many respects. Changes may be made in details, particularly in shape, size and arrangement of steps, without exceeding the scope of the present invention. Of course, the scope of the present invention is limited by the language of the appended claims.

Claims

1. A medical device comprising: an elongated shaft having a distal region; a balloon coupled to the distal region, the balloon comprising a wall, a distal waist, a proximal waist, and a body portion located between the distal waist and the proximal waist; a first reinforcement region positioned along the body portion, the first reinforcement region comprising a first plurality of filaments; as well as a second reinforcement region positioned along the body portion, the second reinforcement region comprising a second plurality of filaments; Wherein, the first reinforcement region is circumferentially spaced from the second reinforcement region such that a balloon wall extending between the first reinforcement region and the second reinforcement region is free of filaments.

2. The medical device of claim 1, wherein a balloon wall extending between the first reinforced region and the second reinforced region has a first elasticity, and wherein the first reinforced region and the second reinforced region have a second elasticity that is less than the first elasticity.

3. A medical device according to claim 1 or 2, wherein the balloon is configured to be inflated to a first pressure, wherein the balloon wall without the filaments has a diameter at the first pressure, wherein the first reinforced region has a diameter at the first pressure, and wherein the diameter of the balloon wall without the filaments at the first pressure is greater than the diameter of the first reinforced region.

4. The medical device of any one of claims 1 to 3, wherein the first plurality of filaments are arranged in a braided formation, and wherein the second plurality of filaments are arranged in a braided formation.

5. The medical device of any one of claims 1 to 4, wherein each of the first plurality of filaments and the second plurality of filaments comprises a wire.

6. The medical device of any one of claims 1 to 4, wherein each of the first plurality of filaments and the second plurality of filaments comprises a fiber.

7. The medical device of any one of claims 1 to 7, wherein the first plurality of filaments are arranged as a first strip of braided filaments extending along the body portion, and wherein the second plurality of filaments are arranged as a second strip of braided filaments extending along the body portion.

8. The medical device according to any one of claims 1 to 7, wherein the first reinforced region comprises a reinforcement component, the reinforcement component comprising: Basic materials; a plurality of filaments attached to the base material; as well as a polymer coating attached to the plurality of filaments; The reinforcement assembly is configured to be individually attached to the outer surface of the body.

9. The medical device of any one of claims 1 to 8, wherein the balloon wall comprises an inner layer having a first hardness and an outer layer having a second hardness greater than the first hardness.

10. The medical device of any one of claims 1 to 9, wherein the first reinforced region further comprises a polymer coating disposed along the first plurality of filaments.

11. The medical device of any one of claims 1 to 10, wherein the first reinforced region further comprises a cutting member attached thereto.

12. The medical device of claim 11, wherein the cutting member comprises a wire having a first region and a second region, wherein the first region is configured to be attached to the plurality of filaments, and wherein the second region is configured to extend radially away from the first region.

13. The medical device of claim 12, wherein one or more of the plurality of filaments are engaged with a portion of the first region of the wire.

14. The medical device of claim 11, wherein the cutting member comprises an atherectomy blade.

15. A balloon catheter comprising: an elongated shaft having a distal region; as well as a balloon coupled to the distal region, the balloon comprising a wall and a plurality of reinforced regions extending longitudinally along a cylindrical body portion of the balloon; wherein each of the plurality of reinforcement regions comprises a mesh material; Each of the plurality of reinforced regions is circumferentially spaced apart from one another such that a portion of the balloon wall between any two reinforced regions is free of filaments.

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