Compartmented medical balloon

Abstract

An exemplary medical device is disclosed. The exemplary medical device includes an outer shaft and an inner shaft extending within the outer shaft. The medical device also includes a balloon, the balloon having a distal waist coupled to the distal end of the inner shaft, a proximal waist coupled to the distal end of the outer shaft, an inner surface, and a wall. The medical device also includes a first interior divider panel disposed within the balloon and coupled to both the outer surface of the inner shaft and the inner surface of the balloon, and a second interior divider panel disposed within the balloon and coupled to both the outer surface of the inner shaft and the inner surface of the balloon. The first interior divider panel is circumferentially spaced from the second interior divider panel.

Description

[Technical Field]

[0001] The present disclosure relates to methods and devices for performing valvuloplasty. Specifically, the present disclosure relates to methods and devices for performing valvuloplasty using a partitioned valvuloplasty balloon. This application claims the benefit of U.S. Provisional Patent Application No. 63 / 397,538, filed August 12, 2022, which is incorporated herein by reference. [Background technology]

[0002] Heart valve stenosis or calcification is a common symptom of valvular heart disease and can often be a leading indication for balloon valvuloplasty and / or valve replacement therapy. In some instances, balloon valvuloplasty can be beneficial in improving the lifestyle of patients with valvular stenosis and can also contribute to the success of valve replacement procedures.

[0003] Stenotic or narrowed heart valves can be treated using relatively non-invasive medical procedures, including percutaneous transluminal balloon valvuloplasty (PTBV), percutaneous transcatheter heart valve replacement (PTVR), and combinations thereof. Valvuloplasty procedures typically involve advancing a balloon catheter over a guidewire through an introducer sheath (e.g., an expandable introducer sheath), thereby positioning and inflating the valvuloplasty balloon of the balloon catheter within the heart valve, thereby expanding the narrowed heart valve.

[0004] In other examples, percutaneous transcatheter heart valve replacement (PTVR) may be performed to replace a diseased native heart valve with a prosthetic heart valve. One method of performing percutaneous transcatheter heart valve replacement may include the use of a valvuloplasty balloon to dilate a stenotic heart valve prior to implantation of the heart valve.

[0005] In yet another embodiment, the valvuloplasty balloon may be utilized to expand a replacement heart valve positioned within a stenotic heart valve. Accordingly, there is a continuing need for improved valvuloplasty balloons and improved methods of treating valvular heart disease. Summary of the Invention

[0006] The present disclosure provides design, material, manufacturing, and use alternatives for medical devices. An exemplary medical device includes an outer shaft having a distal end region and an inner shaft extending within the outer shaft, the inner shaft having an outer surface, a proximal end, and a distal end. The medical device further includes a balloon, the balloon having a distal waist coupled to the distal end of the inner shaft, a proximal waist coupled to the distal end of the outer shaft, an inner surface, and a wall. The medical device further includes a first interior divider panel disposed within the balloon and coupled to both the outer surface of the inner shaft and the inner surface of the balloon, and a second interior divider panel disposed within the balloon and coupled to both the outer surface of the inner shaft and the inner surface of the balloon. The first interior divider panel is circumferentially spaced from the second interior divider panel.

[0007] Alternatively or additionally to any of the above embodiments, the balloon is configured to change between an inflated configuration and a deflated configuration, and the balloon includes a first inflation chamber located between the first inner panel and the second inner panel.

[0008] Alternatively or additionally to any of the above embodiments, the balloon is configured to be inflated to a first pressure, wherein the wall of the balloon between the first panel and the second panel has a diameter at the first pressure and a portion of the wall of the balloon attached to the first panel has a diameter at the first pressure, and the diameter of the wall of the balloon between the first panel and the second panel is larger than the diameter of the portion of the wall of the balloon attached to the first panel at the first pressure.

[0009] Alternatively or additionally to any of the above embodiments, both the first panel and the second panel extend along the longitudinal axis of the inner shaft. Alternatively or additionally to any of the above embodiments, the first panel is attached to the inner shaft along a first longitudinal attachment region, the first panel being substantially perpendicular to a tangent line passing through a point on the first attachment region along the inner shaft.

[0010] Alternatively or additionally to any of the above embodiments, the first panel is attached to the inner shaft along a first longitudinal attachment region, the first panel forming an acute angle with respect to a tangent passing through a point on the first attachment region along the inner shaft.

[0011] Alternatively or additionally to any of the above embodiments, the second panel is attached to the inner shaft along a second longitudinal attachment region, the second panel forming an acute angle with respect to a tangent passing through a point on the second attachment region along the inner shaft.

[0012] Alternatively or additionally to any of the above embodiments, the balloon is configured to change between an inflated configuration and a deflated configuration, and portions of the balloon wall adjacent to portions of the balloon wall attached to the first and second panels are configured to fold onto the first and second panels in the deflated configuration.

[0013] Alternatively or additionally to any of the above embodiments, the second panel is configured to fold over the first panel in the contracted configuration. Alternatively or additionally to any of the above embodiments, the balloon further comprises a third internal partition panel, the third internal partition panel attached to the outer surface of the inner shaft and the inner surface of the balloon, the third internal partition panel being circumferentially spaced apart from the second internal partition panel, the balloon including a second inflation chamber located between the third internal panel and the second internal panel, and the first inflation chamber configured to be inflated independently of the second inflation chamber.

[0014] Another exemplary medical device includes an outer shaft having a distal end region and an inner shaft extending within the outer shaft and having an outer surface, a proximal end, and a distal end. The medical device further includes a balloon having a distal waist secured to the distal end of the inner shaft, a proximal waist secured to the distal end of the outer shaft, a wall, and a body portion located between the distal waist and the proximal waist. The medical device further includes a first reinforcing region disposed along the body portion and a first tension member coupled to the first reinforcing region and the inner shaft.

[0015] Alternatively or additionally to any of the above embodiments, the first reinforcement region comprises a first plurality of fibers. Alternatively or additionally to any of the above embodiments, the first tension member includes a first end region, a second end region, and an intermediate region, the intermediate region wrapped around the outer surface of the inner shaft.

[0016] Alternatively or additionally to any of the above embodiments, the first reinforcement region includes a distal end and a proximal end, the first end region of the first tension member being joined to the distal end of the reinforcement region, and the second end region of the first tension member being joined to the proximal end of the reinforcement region.

[0017] Alternatively or additionally to any of the above embodiments, the first tension member comprises fibers. Alternatively or additionally to any of the above embodiments, the balloon is configured to change between an inflated configuration and a deflated configuration, and the first tensioning member applies an inward radial force to the balloon as the balloon changes between the inflated configuration and the deflated configuration.

[0018] Alternatively or additionally to any of the above embodiments, the balloon is configured to change between an inflated configuration and a deflated configuration, and inflation of the balloon imparts a tensile force to the first tensioning member.

[0019] Alternatively or additionally to any of the above embodiments, the device may further include a second reinforcement region disposed along the body portion and a second tension member coupled to the second reinforcement region and the inner shaft.

[0020] Alternatively or additionally to any of the above embodiments, the second tension member is wound around the inner shaft. An exemplary method of using a balloon catheter includes advancing the balloon catheter through a body vessel to a target site. The balloon catheter includes an outer shaft having a distal end region and an inner shaft extending within the outer shaft and having an outer surface, a proximal end, and a distal end. The balloon catheter further includes a balloon, the balloon including a distal waist coupled to the distal end of the inner shaft, a proximal waist coupled to the distal end of the outer shaft, an inner surface, and a wall. The balloon catheter further includes a first interior partition panel disposed within the balloon and coupled to both the outer surface of the inner shaft and the inner surface of the balloon. The balloon catheter further includes a second interior partition panel disposed within the balloon and coupled to both the outer surface of the inner shaft and the inner surface of the balloon. The first interior partition panel is circumferentially spaced from the second interior partition panel. The method further includes inflating the balloon to engage the balloon with the target site, deflating the balloon, and withdrawing the balloon catheter from the body vessel.

[0021] The above summary of some embodiments is not intended to describe each disclosed embodiment or every implementation of the present disclosure. The figures and the following detailed description more particularly exemplify these embodiments. The present disclosure may be more fully understood in consideration of the following detailed description in conjunction with the accompanying drawings. [Brief explanation of the drawings]

[0022] [Figure 1] FIG. 1 is a perspective view of an exemplary medical balloon. [Figure 2A] 2A is a cross-sectional view of the medical balloon of FIG. 1 taken along line 2-2 of FIG. [Figure 2B] 2B is a cross-sectional view of another exemplary embodiment of the medical balloon of FIG. 1 taken along line 2-2 of FIG. [Figure 3] 3 is a cross-sectional view of the medical balloon of FIG. 1 taken along line 3-3 of FIG. [Figure 4] FIG. 4 is a partial exploded view of the medical balloon of FIG. [Figure 5] FIG. 5 is a cross-sectional view of the medical balloon of FIG. 1 in an inflated configuration. [Figure 6] FIG. 6 is a cross-sectional view of the medical balloon of FIG. 1 in a deflated configuration. [Figure 7] FIG. 7 is a cross-sectional view of another exemplary medical balloon. [Figure 8] FIG. 8 is a cross-sectional view of another exemplary medical balloon. [Figure 9] FIG. 9 is a perspective view of another exemplary medical balloon. [Figure 10] 10 is a cross-sectional view of the medical balloon of FIG. 9 taken along line 10-10 of FIG. [Figure 11] FIG. 11 is a perspective view of another exemplary medical balloon. [Figure 12] 12 is a cross-sectional view of the medical balloon of FIG. 11 taken along line 12-12 of FIG. [Figure 13] 13 is a cross-sectional view of the medical balloon of FIG. 11 taken along line 13-13 of FIG. [Figure 14] FIG. 14 is a cross-sectional view of the medical balloon of FIG. 11 in a deflated configuration. [Figure 15] FIG. 15 is a perspective view of another exemplary medical balloon. [Figure 16] 16 is a cross-sectional view of the medical balloon of FIG. 15 taken along line 16-16 of FIG. [Figure 17] FIG. 17 is a cross-sectional view of the medical balloon of FIG. 15 in a deflated configuration. DETAILED DESCRIPTION OF THE INVENTION

[0023] The following description should be read with reference to the drawings, in which like reference numerals refer to like elements in the various views. The detailed description and drawings illustrate exemplary embodiments of the claimed disclosure.

[0024] As described above, medical balloons can be used in a variety of medical procedures. For example, in a valvuloplasty procedure, a valvuloplasty balloon can be used to expand a diseased heart valve. In a percutaneous transcatheter heart valve replacement (PTVR), a valvuloplasty balloon can be used to replace a diseased native heart valve with a prosthetic heart valve.

[0025] The valvuloplasty balloon can be introduced into the patient through an expandable introducer sheath over which a guidewire is placed. The valvuloplasty balloon can then be delivered to the target site by advancing a balloon catheter over the guidewire to the target site. In some cases, the path to the target site can be tortuous and / or narrow. Once at the site, the valvuloplasty balloon can be expanded by injecting fluid into the balloon. Expanding the valvuloplasty balloon radially expands the stenotic heart valve, thereby restoring normal blood flow through the valve.

[0026] In some instances, it may be desirable to utilize a high-pressure valvuloplasty balloon when treating a particular target site (e.g., a stenotic heart valve). To achieve a desired pressure or force on the tissue at the target site, the valvuloplasty balloon may be configured with a thicker balloon wall. However, a thicker balloon wall may increase the profile (e.g., outer diameter) of the balloon when in the deflated configuration. Minimizing the profile of the balloon in the deflated configuration is important because it affects the ease and ability of the valvuloplasty balloon to pass through an introducer sheath, the coronary arteries, and even narrowed heart valves. A reduced profile also allows the deflated balloon to return through the introducer sheath when the system is removed from the patient. It may be desirable to control the folding / refolding mechanism of the valvuloplasty balloon to minimize the balloon's outer diameter in the deflated state. Examples disclosed herein may include valvuloplasty balloons that include partitions, tension members, and reinforcing portions designed to control the balloon's folding mechanism.

[0027] FIG. 1 illustrates an exemplary balloon catheter 10. The balloon catheter 10 may include an expandable medical balloon 20 mounted or secured to the distal end of a catheter shaft 30. The medical balloon 20 may be designed for use in a variety of medical procedures, including valvuloplasty procedures. The catheter shaft 30 may extend from a manifold assembly (not shown) disposed at and attached to the proximal end of the catheter shaft 30. The balloon 20 may further include a body portion 12, a proximal cone 14, a distal cone 16, a proximal waist 15, and a distal waist 17. The body portion 12 may be located between the proximal cone 14 and the distal cone 16. The proximal waist 15 extends proximally from the proximal cone 14, and the distal waist 17 extends distally from the distal cone 16. The balloon 20 may be secured to the catheter shaft 30 at the proximal waist 15. The catheter shaft 30 of the balloon catheter 10 may extend through the interior cavity of the balloon 20 and may be secured to the distal waist 17 of the balloon 20 .

[0028] The shaft 30 can include an inner lumen 32. In at least some embodiments, the inner lumen 32 of the shaft 30 can be a guidewire lumen. Thus, the catheter 10 can be advanced to a desired location over a guidewire. The guidewire lumen 32 can extend along substantially the entire length of the catheter shaft 30, such that the catheter 10 resembles a conventional "over-the-wire" catheter. Alternatively, the guidewire lumen 32 can extend along only a portion of the shaft 30, such that the catheter 10 resembles a "single-operator-exchange" catheter.

[0029] Shaft 30 may further include one or more inflation lumens that may be used, for example, to deliver inflation medium to and from balloon 20. The inflation lumen or lumens may be defined within the space between the outer surface of guidewire lumen 32 and the inner surface of shaft 30.

[0030] The balloon 20 may include a balloon wall composed of one or more layers. Each of these layers may be composed of a different balloon material. For example, the balloon wall 24 of the balloon 20 may include an inner layer and an outer layer. The inner layer is composed of a material having a lower durometer (e.g., softer) than the outer layer. This two-layer structure may be referred to as a two-layer balloon base layer. The inner and outer layers of the two-layer balloon wall 24 may be extruded simultaneously during the balloon manufacturing process. Typical balloon materials may include polymeric materials, some examples of which are listed herein.

[0031] 1 further illustrates that balloon 20 may include one or more interior divider panels (e.g., radially extending interior fins, ribs, posts, walls, dividers, etc.) that divide the interior of balloon 20 into multiple separate inflation chambers. For example, balloon 20 may include one, two, three, four, five, six, seven, eight, or more interior divider panels 22 (e.g., radially extending interior fins, ribs, posts, walls, dividers, etc.) circumferentially arranged about the longitudinal axis of balloon 20. The balloon 20 shown in FIG. 1 includes eight panels 22 (some panels 22 are hidden from view in FIG. 1).

[0032] In some examples, each panel 22 may extend between and be secured to both the shaft 30 and the balloon 20. For example, each panel 22 may include a first end or a first longitudinal extent attached to the outer surface of the shaft 30. Each panel 22 may also include a second end or a second longitudinal extent attached to the inner surface of the balloon 20 along the distal cone region 16, the body portion 12, and the proximal cone region 14. As described in more detail with respect to FIGS. 2A and 2B , the shaft 30, the balloon 20, and any two adjacent interior divider panels 22 may define an interior chamber 24 located between adjacent panels 22. In other words, each panel 22 may be sealed along the outer surface of the shaft 30 and the inner surface of the balloon 20 such that each chamber 24 defines a separate and distinct inflation region of the balloon 20. Each separate inflation chamber 24 may be fluidly isolated from one or more of the other inflation chambers 24 within the balloon 20. For example, in some instances, each separate inflation chamber 24 may be fluidly isolated from each other inflation chamber 24 within the balloon 20 .

[0033] In some examples, a manifold attached to the outer shaft 20 can be configured to allow for selective inflation of one or more chambers 24. In other words, the balloon catheter 10 can include a manifold that allows for inflation of each chamber 24 independently of one or more other chambers 24. In some examples, the balloon catheter 10 can include a manifold that allows for inflation of each chamber 24 independently of each other chamber 24. Thus, even if a single chamber 24 fails to inflate, one or more other chambers 24 can still inflate.

[0034] 2 is a cross-sectional view of the medical balloon of FIG. 1 taken along line 2-2 in FIG. 1. FIG. 2A shows interior divider panels 22 circumferentially disposed around the outer surface of the shaft 30. Each panel 22 can include a first end or first extent attached to the outer surface of the shaft 30. Each panel 22 can also include a second end or second extent attached to the inner surfaces of the distal cone region 16, the body portion 12, and the proximal cone region 14. Each panel 24 can be a monolithic structure bonded between the shaft 30 and the balloon 20, or can extend radially outward from the outer surface of the shaft 30 to the inner surface of the balloon 20 to form individual panels (e.g., walls, ribs, etc.) circumferentially spaced apart from one another, as described herein.

[0035] 2A further illustrates that the catheter shaft 30 may include multiple inflation lumens defined between one or more rib members 33 that extend longitudinally from the distal end region of the catheter shaft 30 to a manifold that may be attached to the proximal end of the catheter shaft 30. Each rib member 33 may establish multiple separate inflation lumens. For example, FIG. 2A illustrates that the rib members 33 may divide the catheter shaft 30 into eight separate and distinct inflation lumens.

[0036] As mentioned above, FIG. 2A illustrates that any two adjacent panels 22 can define separate inflation lumens disposed between the two adjacent panels 22. FIG. 2A further illustrates that the balloon 20 can include multiple openings 26 in fluid communication with one or more separate inflation lumens of the catheter shaft 30. For example, the catheter can include at least one opening 26 located in each separate inflation lumen. The at least one opening 26 is in fluid communication with each inflation chamber 24, thereby allowing inflation fluid to flow from the inflation lumen of the catheter shaft 30 into the respective inflation chamber 24. The openings 26 can be circumferentially aligned with each inflation chamber 24 to allow inflation medium (e.g., inflation fluid) to flow from the inflation lumen into the inflation chamber 24. As mentioned above, the balloon catheter 10 can have a manifold that allows each chamber 24 to be inflated independently of the other chambers 24. For example, the balloon catheter 10 can include one or more independent inflation lumens in fluid communication with each inflation chamber 24. The one or more independent inflation lumens, via the manifold, allow for independent inflation of one or more chambers 24. As mentioned above, each inflation chamber 24 may be in fluid communication with a separate, dedicated inflation lumen extending through the catheter shaft 30. Thus, even if a single chamber 24 fails to inflate, one or more other chambers 24 can still inflate.

[0037] FIG. 2B is a cross-sectional view of another exemplary medical balloon catheter 10′. The medical balloon catheter 10′ may be similar in form and function to the medical balloon catheter 10 described above. For example, the medical balloon catheter 10′ may include a catheter shaft 30 disposed within the balloon body portion 12, as described above. Furthermore, the cross-sectional view shown in FIG. 2B illustrates that the balloon 20 may include one or more interior divider panels 22′ circumferentially spaced about the exterior surface of the catheter shaft 30. The divider panels 22′ divide the balloon 20 into multiple separate inflation chambers 24. Each separate inflation chamber 24 may be fluidly isolated from one or more of the other inflation chambers 24 within the balloon 20. For example, in some instances, each separate inflation chamber 24 may be fluidly isolated from each of the other inflation chambers 24 within the balloon 20.

[0038] The interior divider panels 22′ may be similar in form and function to the interior panels 22 described herein. Each panel 22′ may extend between and be secured to both the shaft 30 and the wall of the balloon 20. For example, each panel 22′ may include a first end or a first extent attached to the outer surface of the catheter shaft 30. Each panel 22′ may also include a second end or a second extent attached to the inner surfaces of the proximal cone region 14, the body portion 12, and the distal cone region 16. Each panel 22′ may be a monolithic structure extending radially outward from the outer surface of the catheter shaft 30 to the inner surfaces of the proximal cone region 14, the body portion 12, and the distal cone region 16 to form circumferentially spaced individual panels 22′ (e.g., fins, ribs, posts, walls, dividers, etc.) as described herein.

[0039] FIG. 2B further illustrates that the balloon 20 may include multiple openings 26 in fluid communication with one or more inflation lumens of the balloon catheter 10. For example, the catheter 10 may include at least one opening 26 in fluid communication with each inflation chamber 24, thereby allowing inflation fluid to flow from the inflation lumen of the catheter shaft 30 into the respective inflation chamber 24. The openings 26 may be circumferentially aligned with each inflation chamber 24 to allow inflation medium (e.g., inflation fluid) to flow from the inflation lumen into the inflation chamber 24. As described above, the balloon catheter 10′ may include a manifold that allows inflation of each chamber 24 independently of one or more other chambers 24. In some examples, the balloon catheter 10 may include a manifold that allows inflation of each chamber 24 independently of each of the other chambers 24. For example, the balloon catheter 10′ may include one or more independent inflation lumens that allow independent inflation of one or more chambers 24 via the manifold. Thus, even if a single chamber 24 fails to inflate, one or more of the other chambers 24 can still inflate.

[0040] 2B further illustrates that one or more of the panels 22′ can extend from the outer surface of the catheter shaft 30 at an angle, such that the panels 22′ form an iris-type structure around the catheter shaft 30. For example, the detailed view of FIG. 2B illustrates that each panel 22′ can form an acute angle θ with a tangent 34 that extends through the attachment point 36 of the panel 22′ to the outer surface of the catheter shaft 30.

[0041] Figure 3 is a cross-sectional view of the medical balloon catheter 10 taken along line 3-3 in Figure 1. Figure 3 shows two interior divider panels 22 circumferentially offset 180 degrees from one another. As described herein, each panel 22 may include a first longitudinal extent attached to the outer surface of the catheter shaft 30 (e.g., a first edge of each panel is attached to and extends longitudinally along the outer surface of the catheter shaft 30). Each panel 22 may also include a second longitudinal extent attached to the inner surface of the balloon 20 and extending along the proximal cone region 14, the body portion 12, and the distal cone region 16 (e.g., a second edge of each panel is attached to and extends longitudinally along the inner surfaces of the proximal cone region 14, the body portion 12, and the distal cone region 16).

[0042] As also described herein, FIG. 3 illustrates that the catheter shaft 30 can include multiple openings 26 that are in fluid communication with one or more inflation lumens of the balloon catheter 10. As shown in FIGS. 2A and 2B, one or more of the multiple openings 26 can be circumferentially aligned with each inflation chamber 24 defined by any two adjacent panels 22. FIG. 3 further illustrates that the multiple openings 26 can extend along the longitudinal axis of the balloon 20 such that longitudinally aligned openings 26 are in fluid communication with each inflation chamber 24. Thus, each individual inflation lumen 24 (defined between any two panels 22) can be inflated through multiple openings 26 that are aligned with one another along the longitudinal axis of the balloon 20.

[0043] FIG. 4 shows an exploded view of various components of the balloon catheter 10. For example, FIG. 4 shows a catheter shaft 30, multiple circumferentially spaced interior divider panels 22, and a portion of the body portion 12 of the balloon 20. FIG. 4 illustrates that the multiple interior divider panels 22 can be evenly spaced circumferentially around the catheter shaft 30. FIG. 4 also illustrates that the balloon catheter 10 can include eight panels 22 (one panel 22 is hidden from view in FIG. 4 ) that define eight inflation chambers 24 (one inflation chamber 24 defined between two adjacent panels 22). In some examples, the balloon catheter 10 can include fewer or more than eight divider panels 22. For example, the balloon catheter 10 can include two, three, four, five, six, seven, eight, nine, ten, or more divider panels and associated inflation chambers. 4 further illustrates that each panel 22 can include an outermost edge (sometimes referred to herein as a second edge) configured to match the shape (e.g., contour, geometry, etc.) of the inner surface of balloon 20. For example, it can be seen from FIG. 4 that each panel 22 can have a shape that matches and be sealed to the inner surfaces of proximal cone 14, body portion 12, and distal cone 16 of balloon 20 shown in FIG. 1. In some examples, panels 22 can be integrally formed with body portion 12 of balloon 20 such that they are a monolithic structure of body portion 12. In other examples, panels 22 can be formed separately and then secured to body portion 12 of balloon 20.

[0044] In some examples, the balloon catheters 10 described herein may be constructed by extruding the interior partition panels 22 in conjunction with the extrusion of the balloon 20. To complete the construction of the balloon catheter 10, the catheter shaft 30 may then be inserted into the center of the panels 22, whereby each panel 22 may be attached to the outer surface of the catheter shaft 30 (via any suitable attachment technique, including, but not limited to, adhesive bonding, laser welding, etc.). In other manufacturing methods, each panel 22 may be individually attached to the outer surface of the catheter shaft 30 to form a catheter shaft / panel subassembly, which may then be inserted and attached to the inner surface of the balloon 20. In yet other manufacturing methods, each panel 22 may be attached to the inner surface of the balloon (via any suitable attachment technique, including, but not limited to, adhesive bonding, laser welding, etc.), which may then be attached to the catheter shaft 30. Furthermore, in some examples, channels may be formed along the inner surface of the balloon into which the panels 22 may be positioned. After the panels 22 are positioned in the channels, the balloon and panels 22 may be thermally bonded to each other.

[0045] The detailed view of Figure 4 shows that the catheter shaft 30 can include one or more openings 26 circumferentially aligned with each inflation chamber 24 defined by any two adjacent panels 22 of the balloon 20. Figure 4 further shows that the openings 26 can extend along the longitudinal axis of the catheter shaft 30 such that the longitudinally aligned openings 26 are in fluid communication with each inflation chamber 24. Thus, each individual inflation lumen 24 (defined between any two panels 22) can be inflated through multiple openings 26 aligned with one another along the longitudinal axis of the balloon 20.

[0046] FIG. 5 illustrates a cross-sectional view of the balloon 20 of the balloon catheter 10, showing that inflation medium (e.g., inflation fluid) is routed through the multiple inflation lumens of the catheter 10 and passes through the openings 26 to inflate each of the chambers 24 defined between adjacent panels 22. Arrows 38 in FIG. 5 indicate inflation fluid flowing from the inflation lumens to the individual chambers 24. As described herein, in some examples, the balloon catheter 10 may include a manifold configured to allow selective inflation of one or more inflation chambers 24. Thus, if one or more of the multiple inflation chambers 4 fail to inflate, the remaining chambers 24 can continue to inflate.

[0047] FIG. 5 further illustrates that each individual panel 22 can be configured to prevent a portion of the balloon 20 wall from extending radially outward during inflation of the balloon 20. For example, as shown in FIG. 5, when the balloon 20 is inflated, the portion of the balloon wall extending between any two panels 22 can expand radially outward beyond the radial extent of the individual panels 22. The balloon 20 material located between any two points where the balloon material is attached to the panels 22 can define the maximum radial extent of the balloon 20 during inflation. In other words, during inflation, each panel 22 can have sufficient strength to withstand the radial expansion forces of the balloon 20. Thus, each panel 22 can prevent the portion of the balloon 20 located immediately radially outside the corresponding panel 22 from expanding radially outward. This allows the portion of the balloon 20 located between any two adjacent panels 22 to extend radially outward (e.g., bulge outward) relative to the portion of the balloon 20 attached to the panels 22. Such a configuration may provide the balloon 20 with a plurality of longitudinal grooves or valleys disposed around the circumference of the balloon 20 between adjacent longitudinal ridges or peaks.

[0048] Figure 6 shows the balloon 10 shown in Figure 5 after a vacuum (i.e., negative pressure) has been applied to deflate the balloon 20. When a vacuum is applied to the inflation medium, the walls of the balloon 20 may be drawn toward and / or inwardly toward the panels 22. Figure 6 illustrates that the panels 22 may be configured with sufficient column strength to maintain their relative shape even as the balloon 20 radially collapses onto the panels 22. Additionally, designing the panels 22 to have sufficient column strength to maintain their relative shape during deflation of the balloon 20 can result in a predictable deflated cross-sectional shape of the balloon 20.

[0049] As shown in FIG. 6, the cross-sectional shape of the deflated balloon 20 creates a relatively uniform distribution of balloon material, resulting in a substantially uniform amount of balloon material disposed along each panel 22 in the deflated configuration. The uniform distribution of balloon material along the panels 22 may also allow the balloon 20 to more efficiently refold in a symmetrical and uniform configuration. In other words, the configuration of the panels 22 (as shown in FIG. 6) and the deflated configuration of the balloon 20 may allow for a refolded balloon 20 that includes a small outer profile (e.g., a reduced overall outer diameter) in the deflated configuration. The small outer profile may be beneficial when retracting the deflated balloon 20 into an introducer sheath.

[0050] FIG. 7 is a cross-sectional view of another exemplary medical balloon catheter 10″. The medical balloon catheter 10″ may be similar in form and function to the medical balloon catheter 10 described above. For example, the medical balloon catheter 10″ may include a catheter shaft 30 disposed within the balloon body portion 12, as described herein. FIG. 7 further illustrates that the balloon 20 may include one or more interior divider panels 22″ spaced apart around the catheter shaft 30 to divide the balloon 20 into multiple separate inflation chambers 24. Each separate inflation chamber 24 may be fluidly isolated from one or more of the other inflation chambers 24 within the balloon 20. For example, in some instances, each separate inflation chamber 24 may be fluidly isolated from each of the other inflation chambers 24 within the balloon 20.

[0051] The interior divider panels 22" may be similar in form and function to the interior panels 22 described herein. Each panel 22" may extend between and be secured to both the catheter shaft 30 and the wall of the balloon 20. For example, each panel 22" may include a first end or a first extent attached to the outer surface of the catheter shaft 30. Each panel 22" may also include a second end or a second extent attached to the inner surface of the balloon 20 (along the proximal cone region 14, the body portion 12, and the distal cone region 16). Each panel 22" may be a monolithic structure extending radially outward from the outer surface of the catheter shaft 30 to the inner surface of the balloon 20 to form circumferentially spaced apart panels 22" (e.g., fins, ribs, posts, walls, dividers, etc.) as described herein.

[0052] FIG. 7 further illustrates that the catheter shaft 30 may include multiple openings 26 in fluid communication with one or more inflation lumens of the catheter 10". For example, the catheter 10" may include at least one opening 26 in fluid communication with each inflation chamber 24, thereby allowing inflation fluid to flow from the inflation lumen of the catheter 10" into the respective inflation chamber 24. As shown in FIG. 7, an opening 26 may be circumferentially aligned with each inflation chamber 24 defined by any two adjacent panels 22". The openings 26 may be circumferentially aligned with each inflation chamber 24, thereby allowing inflation medium (e.g., inflation fluid) to flow from the inflation lumen of the balloon catheter 10" into the inflation chamber 24. As described above, the balloon catheter 10" may include a manifold that allows inflation of each chamber 24 independently of one or more other chambers 24. In some examples, the balloon catheter 10" may include a manifold that allows inflation of each chamber 24 independently of each other chamber 24.

[0053] FIG. 7 further illustrates that the balloon catheter 10″ can include interior divider panels 22″ disposed about the catheter shaft 30 to form three separate inflation chambers 24. As shown in FIG. 7, the panels 22″ can be disposed about the catheter shaft 30 to form inflation chambers 24 having different sizes (e.g., one or more of the inflation chambers 24 of the balloon 10″ can have a different size than the other chambers 24). For example, FIG. 7 illustrates that the balloon catheter 10″ can be designed to include three panels 22″ distributed about the catheter shaft 30 in a configuration that defines two inflation chambers 24 that are substantially uniform in size and a third inflation chamber 24 that is larger than each of the other uniformly sized inflation chambers 24.

[0054] FIG. 8 is a cross-sectional view of another exemplary medical balloon catheter 10′″. The medical balloon catheter 10′″ may be similar in form and function to the medical balloon catheter 10 described above. For example, the medical balloon catheter 10′″ may include a catheter shaft 30 disposed within the balloon body 12, as described above. Additionally, the cross-sectional view shown in FIG. 8 illustrates that the balloon 20 may include one or more interior divider panels 22′″ spaced about the exterior of the catheter shaft 30, dividing the balloon 20 into multiple separate inflation chambers 24. Each separate inflation chamber 24 may be fluidly isolated from one or more of the other inflation chambers 24 within the balloon 20. For example, in some instances, each separate inflation chamber 24 may be fluidly isolated from each of the other inflation chambers 24 within the balloon 20.

[0055] The interior divider panels 22''' may be similar in form and function to the interior panels 22 described herein. Each panel 22''' may extend between and be secured to both the catheter shaft 30 and the wall of the balloon 20. For example, each panel 22''' may include a first end or a first extent attached to the outer surface of the catheter shaft 30. The panel 22''' may also include a second end or a second extent attached to the inner surface of the balloon 20 (along the proximal cone region 14, the body portion 12, and the distal cone region 16). Each panel 22''' may be a monolithic structure extending radially outward from the outer surface of the catheter shaft 30 to the inner surface of the balloon 20 to form circumferentially spaced individual panels 22''' (e.g., fins, ribs, posts, walls, dividers, etc.) as described herein.

[0056] FIG. 8 illustrates that the catheter shaft 30 can include multiple openings 26 that are in fluid communication with one or more inflation lumens of the balloon catheter 10'". For example, the catheter 10'" can include at least one opening 26 in fluid communication with each inflation chamber 24, thereby allowing inflation fluid to flow from the inflation lumen 32 of the catheter 10'" into the respective inflation chamber 24. As shown in FIG. 8, an opening 26 can be circumferentially aligned with each inflation chamber 24 defined by any two adjacent panels 22'". The openings 26 can be circumferentially aligned with each inflation chamber 24, thereby allowing inflation medium (e.g., inflation fluid) to flow from the inflation lumen of the balloon catheter 10'" into the inflation chamber 24. As described above, the balloon catheter 10'" can include a manifold that allows inflation of each chamber 24 independently of one or more other chambers 24. In some examples, the balloon catheter 10''' may include a manifold that allows inflation of each chamber 24 independently of each other chamber 24.

[0057] FIG. 8 further illustrates that the balloon catheter 10′″ can include interior divider panels 22′″ that divide the interior of the balloon 20 into multiple inflation chambers 24, with one or more of the interior divider panels 22′″ extending a greater distance away from the catheter shaft 30 than the other interior divider panels 22′″. In other words, one or more of the divider panels 22′″ can have a greater radial height than the other divider panels 22′″. In the example of FIG. 8 , one or more of the divider panels 22′″ extend a greater distance away from the outer surface of the catheter shaft 30 than the other panels 22′″. It can be seen from FIG. 8 that this configuration causes the central longitudinal axis of the catheter shaft 30 to be offset from the central longitudinal axis of the balloon 20. Furthermore, FIG. 8 illustrates a configuration in which the inflation chambers 24 (defined by adjacent panels 22′″) can all be different sizes. For example, FIG. 8 shows that the balloon 10′″ can be designed to include six panels 22′″, each panel 22′″ distributed around the catheter shaft 30 in a configuration that defines six inflation chambers 24 having different radial extents and sizes.

[0058] FIG. 9 illustrates another exemplary balloon catheter 100. The balloon catheter 100 may include an expandable medical balloon 120 attached to or secured to a catheter shaft, such as the distal end of an outer catheter shaft 130. The medical balloon 120 may be designed for use in a variety of medical procedures, including valvuloplasty procedures. The catheter shaft 130 may extend from a manifold assembly (not shown) disposed at and attached to the proximal end of the catheter shaft 130. The balloon 120 may further include a body portion 112, a proximal cone 114, a distal cone 116, a proximal waist 115, and a distal waist 117. The body portion 112 may be located between the proximal cone 114 and the distal cone 116. The proximal waist 115 extends proximally from the proximal cone 114, and the distal waist 117 extends distally from the distal cone 116. The balloon 120 may be secured to an outer catheter shaft 130 at the proximal waist 115. The catheter shaft 130 of the balloon catheter 110 may extend through the interior of the balloon 120 and may be secured to the distal waist 117 of the balloon 120.

[0059] 9 further illustrates that the medical balloon 120 may include one or more interior divider panels 122 (e.g., radially extending interior fins, ribs, posts, walls, dividers, etc.) circumferentially disposed about the longitudinal axis of the balloon 120 and dividing the interior of the balloon 120 into multiple separate inflation chambers. The panels 122 may be similar in form and function to the panels 22 described herein. Note that, for simplicity, FIG. 9 illustrates the catheter 100 including two panels 122. However, it will be understood that the balloon 120 may include one, two, three, four, five, six, seven, eight, or more panels 122. For example, Figure 10, a cross-sectional view of balloon catheter 100 taken along line 10-10 in Figure 9, shows that balloon 120 may include eight internal partition panels 122, 125a, 125b, 125c, 125d (e.g., radially extending internal fins, ribs, posts, walls, partitions, etc.) arranged circumferentially around the longitudinal axis of balloon 120.

[0060] Similar to the discussion herein regarding the panels 22 of the balloon 20, each panel 122 can include a first end or a first longitudinal extent attached to the outer surface of the catheter shaft 130. Each panel 122 can also include a second end or a second longitudinal extent attached to the inner surface of the balloon 120 and extending along the distal cone region 116, the body portion 112, and the proximal cone region 114. Thus, as shown in FIG. 10 , any two adjacent interior divider panels 122 can define an interior chamber 124 disposed between the adjacent panels 122. In other words, each panel 122 can be sealed along the outer surface of the catheter shaft 130 and the inner surfaces of the distal cone region 116, the body portion 112, and the proximal cone region 114, such that each chamber 124 defines a separate and distinct inflation region of the balloon 120. Each separate inflation chamber 124 can be fluidly isolated from one or more of the other inflation chambers 124 within the balloon 120. For example, in some instances, each separate inflation chamber 124 can be fluidly isolated from each of the other inflation chambers 124 within the balloon 120.

[0061] 9 and 10 further illustrate that the exemplary balloon 120 can include one or more panels 122a, 122b, 122c, 122d having proximal end regions 152a, 152b, 152c, 152d that are not attached to the outer surface of the catheter shaft 130. For example, FIG. 9 illustrates a panel 122 that includes a proximal end region 125 that is not attached to the outer surface of the catheter shaft 130 (FIG. 9 illustrates that the panel 122 is not attached to the outer surface of the catheter shaft 130 between the attachment point 127 and the proximal end 140 of the proximal end region 125 of the panel 122).

[0062] As mentioned above, FIG. 10 illustrates interior divider panels 122 circumferentially disposed around the exterior surface of the catheter shaft 130. FIG. 10 illustrates that any two adjacent panels 122 can define separate inflation chambers 124 disposed between the two adjacent panels 122. FIG. 10 also illustrates multiple openings 126 in fluid communication with one or more inflation lumens of the balloon catheter 100. For example, the catheter 100 can include at least one opening 126 in fluid communication with each inflation chamber 124, thereby allowing inflation fluid to flow from the inflation lumen of the catheter 100 into the respective inflation chamber 124. The openings 126 can be circumferentially aligned with each inflation chamber 124, thereby allowing inflation medium (e.g., inflation fluid) to flow from the inflation lumen into the inflation chamber 124. As described herein, the balloon catheter 100 can include a manifold that allows inflation of each chamber 124 independently of the other chambers 124. For example, similar to that described above with respect to catheter 10, balloon catheter 100 may include one or more independent inflation lumens in fluid communication with each inflation chamber 124. The one or more independent inflation lumens, via a manifold, allow for independent inflation of one or more chambers 124. Thus, each inflation chamber 124 may be in fluid communication with a separate, dedicated inflation lumen extending through the catheter shaft. Thus, even if a single chamber 124 fails to inflate, one or more other chambers 124 can still inflate.

[0063] Figure 10 further illustrates the proximal end region 125 of the panel 122 that is not attached to the outer surface of the catheter shaft 130. Figure 10 illustrates a radial gap 152 between the panel 122 and the outer surface of the catheter shaft 130. When the balloon 120 is inflated, the portion of the balloon wall adjacent the proximal end region 125 of the panel 122 (depicted in Figure 10 as balloon wall "X") may expand radially outward to a greater extent than other portions of the balloon wall (e.g., the portion of the balloon 120 adjacent the proximal end region 125 of the panel 122 that is not attached to the outer shaft surface is not inhibited from expanding radially outward compared to the portion of the balloon 120 that is coupled to the panel 122 that is attached to the outer shaft surface).

[0064] With respect to the openings of any of the above-described embodiments, the multiple openings 26, 126 communicating with any one of the chambers 24, 124 may be longitudinally spaced equidistantly along the catheter shaft 30, 130 or may be longitudinally spaced in other ways. For example, more openings 26, 126, larger size (e.g., larger diameter) openings 26, 126, and / or more closely spaced openings 26, 126 may be provided closer to the distal end of the catheter shaft, and in some instances closer to the distal end region of the chamber 24, 124. Such a configuration may aid in inflating the distal end region of the balloon 20, 120 relative to the proximal end region of the balloon 20, 120. In other examples, more openings 26, 126, larger size (e.g., larger diameter) openings 26, 126, and / or more closely spaced openings 26, 126 may be provided nearer the proximal end of the catheter shaft, in some examples, nearer the proximal end region of the chamber 24, 124. Such a configuration may aid in inflating the proximal end region of the balloon 20, 120 relative to the distal end region of the balloon 20, 120. In still other examples, more openings 26, 126, larger size (e.g., larger diameter) openings 26, 126, and / or more closely spaced openings 26, 126 may be provided along the middle region of the chamber 24, 124 relative to the proximal and distal end regions of the chamber 24, 124. Such a configuration may aid in inflating the middle region of the balloon 20, 120 relative to the proximal and distal end regions of the balloon 20, 120.

[0065] FIG. 11 illustrates an exemplary balloon catheter 200. The balloon catheter 200 may include an expandable medical balloon 220 attached or secured to the distal end of a catheter shaft, such as an outer catheter shaft 230. The medical balloon 220 may be designed for use in a variety of medical procedures, including valvuloplasty procedures. The catheter shaft 230 may extend from a manifold assembly (not shown) disposed at and attached to the proximal end of the catheter shaft 230. The balloon 220 may further include a body portion 212, a proximal cone 214, a distal cone 216, a proximal waist 215, and a distal waist 217. The body portion 212 may be located between the proximal cone 214 and the distal cone 216. The proximal waist 215 extends proximally from the proximal cone 214, and the distal waist 217 extends distally from the distal cone 216. The balloon 220 may be secured to an outer catheter shaft 230 at the proximal waist 215. The catheter shaft of the balloon catheter 200 may include an inner shaft 232 that may extend through the interior cavity of the balloon 220 within the outer catheter shaft 230 and may be secured to the distal waist 217 of the balloon 220.

[0066] The inner shaft 232 can include an inner lumen. In at least some embodiments, the inner lumen of the inner shaft 232 can be a guidewire lumen. Thus, the catheter 200 can be advanced to a desired location over a guidewire. The guidewire lumen can extend along substantially the entire length of the catheter shaft 230, such that the catheter 200 resembles a traditional "over-the-wire" catheter. Alternatively, the guidewire lumen can extend along only a portion of the shaft 230, such that the catheter 200 resembles a "single-operator exchange" catheter.

[0067] The outer shaft 230 may further include an inflation lumen that may be used, for example, to deliver inflation medium to and from the balloon 220. When the outer shaft 230 is disposed over the inner shaft 232, an inflation lumen may be defined within the space between the outer surface of the inner shaft 232 and the inner surface of the outer shaft 230.

[0068] Balloon 220 may include a balloon wall composed of one or more layers. Each of these layers may be composed of a different balloon material. For example, balloon wall 224 of balloon 220 may include an inner layer and an outer layer. The inner layer is composed of a material having a lower durometer (e.g., softer) than the outer layer. This two-layer structure may be referred to as a two-layer balloon base layer. The inner and outer layers of two-layer balloon wall 224 may be extruded simultaneously during the balloon manufacturing process. Typical balloon materials may include polymeric materials, some examples of which are listed herein.

[0069] Also, as shown in Figure 11, balloon 220 can include one or more longitudinally extending reinforcing portions disposed around the circumference of balloon 220. For example, balloon 220 can include one, two, three, or more reinforcing portions circumferentially disposed around the longitudinal axis of balloon 220. Balloon 220 shown in Figure 11 includes three reinforcing portions 222a, 222b, and 222c. Note that reinforcing portion 222c is hidden from view in Figure 11 but is shown in Figures 13 and 14.

[0070] In some examples, the reinforcing portions 222a, 222b, 222c can include one or more interwoven (e.g., braided, woven, or knitted) filaments 234 attached to and / or embedded in the inner surface of the balloon 220. The filaments 234 can be composed of a variety of materials. For example, the filaments 234 can be composed of wire, fiber (e.g., Kevlar® fiber), silk, or other suitable materials. In other examples, the reinforcing portions 222a, 222b, 222c can include continuous flexible strips of material attached to and / or embedded in the inner surface of the balloon 220. In yet other examples, the reinforcing portions 222a, 222b, 222c can include polyimide strips, liquid crystal polymer, or other similar materials.

[0071] In some examples, each of the reinforcement segments 222a, 222b, and 222c of FIG. 11 can include one or more braided or interwoven fibers 234 disposed along the inner surface of the balloon 220. In some examples, the fibers 234 are braided, wrapped, wrapped, or woven in various configurations along each of the reinforcement segments 222a, 222b, and 222c of the balloon 220. For example, the fibers 234 can be directly attached to the inner surface of the balloon 220. However, in other examples, the fibers 234 can be extruded with the balloon material such that the fibers 234 are partially embedded within the wall 224 of the balloon 220. In yet other examples, the fibers 234 can be extruded with the balloon material such that the fibers 234 are completely embedded within the wall 224 of the balloon 220. Alternatively, the fibers 234 can be bonded to the inner surface of the balloon 220 with an adhesive. The adhesive can include a thermosetting adhesive that cures either via a chemical reaction or irradiation. In some instances, a polymer coating may be applied over the balloon 220 .

[0072] Figure 11 further illustrates that catheter 200 can further include one, three, or more tension members 226a, 226b, 226c (e.g., tethers) attached to reinforcement portions 222a, 222b, 222c of balloon 220 and located within balloon 220. For example, Figure 11 illustrates that catheter 200 can include a first tension member 226a within balloon 220, the first tension member having a first end attached to the first end of reinforcement portion 222a and a second end attached to the second end of reinforcement portion 222a. As shown in Figure 11, the portion of tension member 226a extending between the first and second ends of tension member 226a can be wrapped (e.g., helically wrapped) around inner shaft 232. Similarly, FIG. 11 illustrates that catheter 200 can include a second tension member 226b within balloon 220, the second tension member 226b having a first end attached to the first end of reinforcing portion 222b and a second end attached to the second end of reinforcing portion 222b. As illustrated in FIG. 11, the portion of tension member 226b extending between the first and second ends of tension member 226b can be wound (e.g., spirally wound) around inner shaft 232. As described herein, although reinforcing portion 222c is hidden from view in FIG. 11, FIG. 11 also illustrates tension member 226c wound (spiral wound) around inner shaft 232. In some examples, the inner member can include a reinforcing wire (e.g., braid, mesh, etc.). The reinforcing wire can define a layer of inner shaft 232. Additionally, in some examples, one or more of the tension members 226a, 226b, 226c may be integrated with the stiffening wire of the inner shaft 232. In other words, in some examples, the tension members 226a, 226b, 226c may be combined with one or more additional wires to form a stiffening wire braid in the wall of the inner shaft 232.

[0073] Additionally, tension member 226c can include a first end attached to the first end of reinforcing portion 222c and a second end attached to the second end of reinforcing portion 222c, and can be located inside balloon 220. Reinforcing portion 222c and tension member 226c are shown in Figures 13 and 14.

[0074] FIG. 12 is a cross-sectional view of balloon 220 taken along line 12-12 in FIG. 11. As described herein, FIG. 12 shows reinforcing portions 222a and 222b (reinforcing portion 222c is hidden from view) extending longitudinally along body portion 212 of balloon 220. Additionally, the detailed view of FIG. 12 shows filaments 234 disposed along the inner surface of balloon wall 224. As described herein, braided or interwoven fibers 234 may be disposed directly on the inner surface of balloon wall 224 (e.g., braided or interwoven fibers 234 may be attached directly to the inner surface of balloon wall 224). However, in other examples, fibers 234 may be partially or completely embedded within balloon wall 224 (e.g., via an extrusion process or other suitable manufacturing method).

[0075] As described herein, FIG. 12 shows a first tension member 226a having a first end attached to the first end of reinforcing portion 222a and a second end attached to the second end of reinforcing portion 222a. The portion of tension member 226b extending between the first and second ends of tension member 226b within balloon 220 can be wound around inner shaft 232. FIG. 12 also shows a second tension member 226b having a first end attached to the first end of reinforcing portion 222b and a second end attached to the second end of reinforcing portion 222b. As shown in FIG. 12, the portion of tension member 226b extending between the first and second ends of tension member 226b within balloon 220 can be wound around inner shaft 232.

[0076] 12 also shows that at the first end region of balloon body portion 212, first end 242 of first tensile member 226a can be attached or secured to braided or interwoven fibers 234, and at the second end region of balloon body portion 212, second end 243 of first tensile member 226a can be attached or secured to braided or interwoven fibers 234. In some examples, first end 242 of first tensile member 226a can be embedded in reinforced portion 222a, and second end 243 of first tensile member 226a can be embedded in reinforced portion 222a. In other examples, first end 242 of first tensile member 226a can be adhesively bonded to reinforced portion 222a, and second end 243 of first tensile member 226a can be adhesively bonded to reinforced portion 222a. In other examples, the first tension member 226a can extend along the entire length of the reinforced portion 222a. In other words, in some examples, the first tension member 226a forms a loop such that a portion of the first tension member 226a is wrapped around the inner shaft 232 and a portion of the first tension member 226a extends along the entire length of the reinforced portion 222a. Similarly, the second tension member 226b can extend along the entire length of the reinforced portion 222b. In other words, in some examples, the second tension member 226b forms a loop such that a portion of the second tension member 226b is wrapped around the inner shaft 232 and a portion of the second tension member 226b extends along the entire length of the reinforced portion 222b.

[0077] Attaching first end 242 and second end 243 of first tension member 226a to reinforced portion 222a may include securing first tension member 226a to reinforced portion 222a by passing braided or interwoven fibers 234 over and / or under both first end 242 and second end 243 of first tension member 226a. Second tension member 226b and third tension member 226c can be attached to second reinforced portion 226b and third reinforced portion 226c, respectively, using the same attachment methods described for attaching first tension member 226a to first reinforced portion 222a.

[0078] In some examples, tension members 226a, 226b, 226c can be formed from high-strength fiber (e.g., Kevlar®, Aramid®, Pebax®), wire, silk, nylon, or other suitable materials. In yet other examples, tension members 226a, 226b, 226c can include elastic members. Furthermore, each tension member 226a, 226b, 226c can be designed to exert a radially inward force on each reinforcement portion 222a, 222b, 222c when the balloon is deflated. The exertion of a radially inward force on each reinforcement portion 222a, 222b, 222c upon balloon deflation can cause the balloon 220 to refold (e.g., recoil) to a reduced outer profile configuration before the balloon is retracted into the introducer sheath. In other words, by applying a radially inward force to each of reinforcing portions 222a, 222b, 222c upon balloon deflation, a refolded balloon 220 can be provided that includes a reduced outer profile in the deflated configuration. The reduced outer profile can be beneficial when retracting the deflated balloon 220 into an introducer sheath. Figures 13 and 14 illustrate mechanisms for applying a radially inward force to balloon 220 to refold it, as described above.

[0079] FIG. 13 shows a cross-sectional view of the balloon 220 taken along line 13-13 in FIG. 12 with the balloon 220 inflated. FIG. 13 also shows three longitudinally extending reinforcing portions 222a, 222b, and 222c circumferentially disposed about the inner shaft 232. FIG. 13 also shows that the three reinforcing portions 222a, 222b, and 222c can be equally spaced about the inner shaft 232. However, in other examples, the three reinforcing portions 222a, 222b, and 222c can be unevenly spaced about the inner shaft 232. As described herein, the balloon 220 can include one, two, three, four, five, six, or more longitudinally extending reinforcing portions (e.g., 222a, 222b, and 222c) disposed about the inner shaft 232.

[0080] Figure 13 further illustrates the braided or interwoven fibers 234 of each reinforcement segment 222a, 222b, 222c disposed along the inner surface of balloon 220. As described herein, it can be seen from Figure 13 that circumferential portions of balloon wall 224 extend between reinforcement segments 222a, 222b, 222c, thereby establishing discrete regions free of fibers 234 and / or reinforcement segments in the continuous balloon wall 224. In some examples, when fully inflated, the circumferential regions of balloon wall 224 free of fibers 234 and / or reinforcement segments 222a, 222b, 222c may extend radially outward to a greater extent than the portions of balloon wall 224 directly outside and attached to reinforcement segments 222a, 222b, 222c. 13 shows three reinforcement segments 222a, 222b, 222c (each including fibers 234) disposed along the inner surface of balloon 220, in some examples, the braided or interwoven fibers 234 of each reinforcement segment 222a, 222b, 222c may be partially or completely embedded within balloon wall 224. In the expanded configuration, tension members 226a, 226b, 226c may be placed in tension to elastically stretch between inner shaft 232 and reinforcement segments 222a, 222b, 222c, respectively.

[0081] FIG. 14 shows a cross-sectional view of balloon 220 in a deflated configuration. Following inflation of balloon 220, as inflation media is withdrawn through outer shaft 230, a negative pressure (i.e., vacuum) can be created that draws the inner surface of balloon 220 radially inward (toward inner shaft 232). As described herein, each tension member 226a, 226b, 226c can be designed to apply a radially inward force to each reinforcement portion 222a, 222b, 222c. In other words, each tension member 226a, 226b, 226c can be designed to pull on the reinforcement portion 222a, 222b, 222c to which it is attached. Thus, tension members 226a, 226b, 226c can be oriented to refold the balloon into the configuration shown in FIG. 14. Tension members 226a, 226b, 226c thereby pull reinforcement portions 222a, 222b, 222c toward inner shaft 232 in a substantially uniform configuration (e.g., reinforcement portions 222a, 222b, 222c are substantially equally spaced around the circumference of inner shaft 232). Applying a radially inward force to each reinforcement portion 222a, 222b, 222c provides a substantially uniform and symmetrical refolded configuration of balloon 220. Furthermore, the uniform and symmetrical refolded configuration of balloon 220 can result in a reduction in the folded profile of deflated balloon 220, which can allow the balloon to be more easily retracted into an introducer sheath used to insert balloon 220 into the body.

[0082] 15 illustrates another exemplary balloon catheter 300. The balloon catheter 300 may include an expandable medical balloon 320 attached to or secured to a catheter shaft, such as the distal end of an outer catheter shaft 330. The medical balloon 320 may be designed for use in a variety of medical procedures, including valvuloplasty procedures. The catheter shaft 320 may extend from a manifold assembly (not shown) disposed at and attached to the proximal end of the catheter shaft 330. The balloon 320 may further include a body portion 312, a proximal cone 314, a distal cone 316, a proximal waist 315, and a distal waist 317. The body portion 312 may be located between the proximal cone 314 and the distal cone 316. The proximal waist 315 extends proximally from the proximal cone 314, and the distal waist 317 extends distally from the distal cone 316. The balloon 320 may be secured to an outer catheter shaft 330 at the proximal waist 315. The catheter shaft of the balloon catheter 300 may include an inner shaft 332 that may extend through the interior cavity of the balloon 320 within the outer catheter shaft 330 and may be secured to the distal waist 317 of the balloon 320.

[0083] The inner shaft 332 can include an inner lumen. In at least some embodiments, the inner lumen of the inner shaft 332 can be a guidewire lumen. Thus, the catheter 300 can be advanced to a desired location over a guidewire. The guidewire lumen can extend along substantially the entire length of the catheter shaft 330, such that the catheter 300 resembles a traditional "over-the-wire" catheter. Alternatively, the guidewire lumen can extend along only a portion of the shaft 330, such that the catheter 300 resembles a "single-operator exchange" catheter.

[0084] The outer shaft 330 may further include an inflation lumen that may be used, for example, to deliver inflation medium to and from the balloon 320. When the outer shaft 330 is disposed over the inner shaft 332, an inflation lumen may be defined within the space between the outer surface of the inner shaft 332 and the inner surface of the outer shaft 330.

[0085] The balloon 320 may include a balloon wall composed of one or more layers. Each of these layers may be composed of a different balloon material. For example, the balloon wall 324 of the balloon 320 may include an inner layer and an outer layer. The inner layer is composed of a material having a lower durometer (e.g., softer) than the outer layer. This two-layer structure may be referred to as a two-layer balloon base layer. The inner and outer layers of the two-layer balloon wall 324 may be extruded simultaneously during the balloon manufacturing process. Typical balloon materials may include polymeric materials, some examples of which are listed herein.

[0086] 15, the balloon 320 may include one or more longitudinally extending reinforcing portions disposed around the circumference of the balloon 320. For example, the balloon 320 may include one, two, three, four, five, six, seven, eight, or more fibers 322 embedded in the wall 324 of the balloon 320. In some examples, the fibers 322 may be formed from high-strength fibers (e.g., Kevlar® fibers, Aramid® fibers, Pebax® fibers), wire, silk, nylon, or other suitable materials. The fibers 322 may extend longitudinally along the body portion 312 of the balloon 320. While FIG. 15 shows the fibers 322 extending along the balloon body portion 312, it is contemplated that the fibers 322 may be embedded within the proximal cone portion 314, the distal cone portion 316, or both the proximal cone portion 314 and the distal cone portion 316.

[0087] FIG. 16 shows a cross-sectional view of the balloon 320 taken along line 16-16 in FIG. 15 with the balloon 320 inflated. FIG. 16 also shows eight longitudinally extending fibers 322 circumferentially arranged around the inner shaft 332. FIG. 16 also shows that the eight fibers 322 may be evenly spaced around the inner shaft 332. However, in other examples, the fibers 322 may be unevenly spaced around the inner shaft 332. As described herein, the balloon 320 may include one, two, three, four, five, six, seven, eight, nine, ten, or more fibers 322 arranged around the inner shaft 332 and extending longitudinally through the body portion 312 (optionally extending longitudinally through or within the proximal cone 314 and / or the distal cone 316).

[0088] FIG. 16 further illustrates fibers 322 embedded within the balloon wall 324 of balloon 320. It can be seen from FIG. 16 that circumferential portions of balloon wall 324 extend between each fiber 322, thereby establishing discrete regions free of fibers 322 in the continuous balloon wall 324. In some examples, when fully inflated, the circumferential regions of balloon wall 324 free of fibers 322 may extend radially outward to a greater extent than the portions of balloon wall 324 having fibers 322 embedded therein. While FIG. 16 illustrates fibers 322 completely embedded in the wall 324 of balloon 320, it is contemplated that in some examples, fibers 322 may be partially embedded in balloon wall 324. It is further contemplated that in some examples, fibers 322 may be directly attached to the inner surface of balloon 320. For example, it is contemplated that fibers 322 may be adhesively attached, laminated, or otherwise attached to the inner surface of balloon 320.

[0089] FIG. 17 shows the balloon 320 of FIG. 16 after a vacuum has been applied to deflate the balloon 320. FIG. 17 further illustrates that each fiber 322 can provide a relatively stiff reinforced region compared to the portions of the balloon wall 324 that extend between the fibers 322 (e.g., the portions of the balloon wall 324 without the fibers 322). Thus, when a vacuum is applied to the balloon 320, the portions of the balloon wall 324 that extend between the fibers 322, i.e., the portions of the balloon wall 324 without the fibers 322, can more easily fold inward toward the inner shaft 332 of the balloon 320, thereby initiating refolding of the balloon 320 into the configuration shown in FIG. 17. Note that the resistance of the fibers 322 of the balloon 320 to folding compared to the rest of the balloon 320 can result in symmetrical refolding of the balloon 320 upon deflation. This symmetrical refolding of the balloon 320 results in a smaller folded profile for the deflated balloon 320, which allows the balloon 320 to be more easily withdrawn into the introducer sheath used for insertion of the balloon 320 into the body.

[0090] Exemplary polymers utilized to manufacture the medical balloons 20, 120, 220, 320 and various components of the balloons 20, 120, 220, 320 disclosed herein include polymers such as polyethylene terephthalate (PET), polyetherimide (PEI), polyethylene (PE), and the like. Some other examples of suitable polymers, including lubricious polymers, 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 ARNITEL® available from DSM Engineering Plastics), polyesters (e.g., polyester elastomers such as HYTREL® available from DuPont), polyamides (e.g., DURETHAN® or Elf Atochem® available from Bayer), and the like. Examples of suitable materials include CRISTAMID® (available from Atochem), elastomeric polyamides, block polyamide / ethers, polyether block amides (PEBA, e.g., available under the trade name PEBAX®), silicone, Marlex® high density polyethylene, Marlex® low density polyethylene, linear low density polyethylene (e.g., REXELL®), polyether ether ketone (PEEK), polyimide (PI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), polysulfone, nylon, perfluoro(propyl vinyl ether) (PFA), other suitable materials, blends, combinations, copolymers, polymer / metal composites, and the like. In some embodiments, it may be desirable to use a higher modulus or generally stiffer material to reduce balloon stretch. The above list of materials includes some examples of higher modulus materials.Some other examples of harder materials include polymers blended with liquid crystal polymers (LCPs), as well as the materials listed above. For example, the mixture can contain up to about 5% LCP.

[0091] The present disclosure should be understood in many respects to be merely illustrative. Changes may be made in details, particularly in matters of shape, size, and arrangement of steps, without exceeding the scope of the present disclosure, which scope is, of course, defined by the language expressed in the appended claims.

Claims

1. A medical device comprising: an outer shaft having a distal end region; an inner shaft extending within the outer shaft and having an outer surface, a proximal end, and a distal end; a balloon including a distal waist coupled to a distal end of the inner shaft, a proximal waist coupled to a distal end of the outer shaft, an inner surface, and a wall; a first interior divider panel disposed within the balloon and coupled to both an outer surface of the inner shaft and an inner surface of the balloon; a second interior divider panel disposed within the balloon and coupled to both an outer surface of the inner shaft and an inner surface of the balloon; The medical device, wherein the first interior divider panel is circumferentially spaced from the second interior divider panel.

2. 10. The medical device of claim 1, wherein the balloon is configured to change between an inflated configuration and a deflated configuration, the balloon including a first inflation chamber located between the first inner panel and the second inner panel.

3. 3. The medical device of claim 1, wherein the balloon is configured to be inflated to a first pressure, the wall of the balloon between the first panel and the second panel having a diameter at the first pressure, and the portion of the wall of the balloon attached to the first panel having a diameter at the first pressure, the diameter of the wall of the balloon between the first panel and the second panel being larger than the diameter of the portion of the wall of the balloon attached to the first panel at the first pressure.

4. The medical device of any one of claims 1 to 3, wherein both the first panel and the second panel extend along a longitudinal axis of the inner shaft.

5. 5. The medical device of claim 1, wherein the first panel is attached to the inner shaft along a first longitudinal attachment region, the first panel being substantially perpendicular to a tangent line passing through a point on the first attachment region along the inner shaft.

6. 6. The medical device of claim 1, wherein the first panel is attached to the inner shaft along a first longitudinal attachment region, the first panel forming an acute angle with a tangent passing through a point on the first attachment region along the inner shaft.

7. 7. The medical device of claim 6, wherein the second panel is attached to the inner shaft along a second longitudinal attachment region, the second panel forming an acute angle with respect to a tangent passing through a point on the second attachment region along the inner shaft.

8. 8. The medical device of claim 1, wherein the balloon is configured to change between an inflated configuration and a deflated configuration, and wherein portions of the balloon wall adjacent to portions of the balloon wall attached to the first and second panels are configured to fold onto the first and second panels in the deflated configuration.

9. The medical device of claim 8 , wherein the second panel is configured to fold over the first panel in the contracted configuration.

10. 3. The medical device of claim 2, wherein the balloon further comprises a third internal partition panel, the third internal partition panel attached to an outer surface of the inner shaft and an inner surface of the balloon, the third internal partition panel being circumferentially spaced from the second internal partition panel, the balloon including a second inflation chamber located between the third internal panel and the second internal panel, the first inflation chamber configured to be inflated independently of the second inflation chamber.

11. A medical device comprising: an outer shaft having a distal end region; an inner shaft extending within the outer shaft and having an outer surface, a proximal end, and a distal end; a balloon including a distal waist secured to the distal end of the inner shaft, a proximal waist secured to the distal end of the outer shaft, a wall, and a body portion located between the distal waist and the proximal waist; a first reinforcement region disposed along the body portion; a first tension member coupled to the first reinforcement region and the inner shaft.

12. The medical device of claim 11 , wherein the first reinforced region comprises a first plurality of fibers.

13. 13. The medical device of claim 11 or 12, wherein the first tension member includes a first end region, a second end region, and an intermediate region, the intermediate region wrapped around an outer surface of the inner shaft.

14. 14. The medical device of claim 13, wherein the first reinforced region includes a distal end and a proximal end, the first end region of the first tension member being joined to the distal end of the reinforced region and the second end region of the first tension member being joined to the proximal end of the reinforced region.

15. The medical device of claim 14 , wherein the first tension member comprises a fiber.

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