Sectional type medical balloon

Abstract

Example medical devices are disclosed. An example medical device includes an outer shaft and an inner shaft extending within the outer shaft. The medical device also includes 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. The medical device further includes a first internal partition panel disposed within the balloon, wherein the first internal partition panel is coupled to both the outer surface of the inner shaft and an inner surface of the balloon; and a second internal partition panel disposed within the balloon, wherein the second internal partition panel is coupled to both the outer surface of the inner shaft and an inner surface of the balloon. In addition, the first internal partition panel is circumferentially spaced away from the second internal partition panel.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 397,538, filed on August 12, 2022, which is incorporated herein by reference. Technical Field

[0003] The present invention relates to methods and apparatus for performing valvuloplasty procedures. More particularly, the present invention relates to methods and apparatus for performing valvuloplasty procedures using a segmented 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 can help improve the lifestyle of patients with valvular stenosis and can also aid in 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), and combinations thereof. Valvuloplasty techniques typically involve advancing a balloon catheter over a guidewire and through an introducer sheath (e.g., an expandable introducer sheath), whereby a valvuloplasty balloon of the balloon catheter is positioned within the heart valve and inflated to dilate the narrowed heart valve.

[0006] 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 using a valvuloplasty balloon to enlarge a stenotic heart valve prior to implanting the heart valve.

[0007] In other examples, an annuloplasty balloon may be used to expand a replacement heart valve that is placed within a stenotic heart valve.Therefore, there is a need for improved annuloplasty balloons and improved methods of treating heart valve disease. Summary of the invention

[0008] The present invention provides designs, materials, manufacturing methods, and use alternatives for medical devices. An example medical device includes an outer shaft having a distal 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 also 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 medical device also includes a first internal partition panel disposed within the balloon, wherein the first internal partition panel is coupled to both the outer surface of the inner shaft and the inner surface of the balloon; and a second internal partition panel disposed within the balloon, wherein the second internal partition panel is coupled to both the outer surface of the inner shaft and the inner surface of the balloon. In addition, the first internal partition panel is circumferentially spaced away from the second internal partition panel.

[0009] Alternatively or additionally to any of the above embodiments, wherein the balloon is configured to transform between an inflated configuration and a collapsed configuration, and wherein the balloon includes a first inflation chamber positioned between the first interior panel and the second interior panel.

[0010] Alternatively or additionally to any of the above embodiments, wherein the balloon is configured to be inflated to a first pressure, and wherein a wall of the balloon between the first panel and the second panel has a diameter at the first pressure, and wherein a portion of the wall of the balloon attached to the first panel has a diameter at the first pressure, and wherein at the first pressure, the diameter of the wall of the balloon between the first panel and the second panel is greater than the diameter of the portion of the wall of the balloon attached to the first panel.

[0011] Alternatively or additionally to any of the above embodiments, wherein both the first panel and the second panel extend along a longitudinal axis of the inner shaft.

[0012] Alternatively or additionally to any of the above embodiments, wherein the first panel is attached to the inner shaft along a first longitudinal attachment area, and wherein the first panel is substantially perpendicular to a tangent along the inner shaft passing through a point on the first attachment area.

[0013] Alternatively or additionally to any of the above embodiments, wherein the first panel is attached to the inner shaft along a first longitudinal attachment area, and wherein the first panel forms an acute angle with respect to a tangent line passing through a point on the first attachment area along the inner shaft.

[0014] Alternatively or additionally to any of the above embodiments, wherein the second panel is attached to the inner shaft along a second longitudinal attachment area, and wherein the second panel forms an acute angle with respect to a tangent line passing through a point on the second attachment area along the inner shaft.

[0015] Alternatively or additionally to any of the above embodiments, the balloon is configured to transform between an inflated form and a collapsed form, and wherein a portion of the balloon wall adjacent to a portion of the balloon wall attached to the first panel and the second panel is configured to collapse onto the first panel and the second panel in a collapsed form.

[0016] Alternatively or additionally to any of the above embodiments, wherein the second panel is configured to be folded onto the first panel in a telescoping configuration.

[0017] Alternatively or additionally to any of the above embodiments, the balloon further comprises a third internal partition panel, wherein the third internal partition panel is attached to the outer surface of the inner shaft and the inner surface of the balloon, wherein the third internal partition panel is circumferentially spaced apart from the second internal partition panel, and wherein the balloon comprises a second inflation chamber positioned between the third internal panel and the second internal panel, and wherein the first inflation chamber is configured to be inflated independently of the second inflation chamber.

[0018] Another example medical device includes an outer shaft having a distal 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 also includes a balloon, the balloon including a distal waist fixed to the distal end of the inner shaft, a proximal waist fixed to the distal end of the outer shaft, a wall, and a body portion positioned between the distal waist and the proximal waist. The medical device also includes a first reinforcement region positioned along the body portion and a first tension member coupled to the first reinforcement region and the inner shaft.

[0019] Alternatively or additionally to any of the above embodiments, wherein the first reinforcement region comprises a first plurality of filaments.

[0020] Alternatively or additionally to any of the above embodiments, wherein the first tension member comprises a first end region, a second end region, and a middle region, and wherein the middle region is wrapped around an outer surface of the inner shaft.

[0021] Alternatively or additionally to any of the above embodiments, wherein the first reinforced region includes a distal end and a proximal end, and wherein the first end region of the first tension member is coupled to the distal end of the reinforced region, and wherein the second end region of the first tension member is coupled to the proximal end of the reinforced region.

[0022] Alternatively or additionally to any of the above embodiments, wherein the first tension member comprises fibers.

[0023] Alternatively or additionally to any of the above embodiments, wherein the balloon is configured to transform between an inflated configuration and a collapsed configuration, and wherein the first tension member applies a radially inward force on the balloon when the balloon transforms between the inflated configuration and the collapsed configuration.

[0024] Alternatively or additionally to any of the above embodiments, wherein the balloon is configured to transform between an inflated configuration and a deflated configuration, and wherein inflation of the balloon applies tension to the first tension member.

[0025] Alternatively or additionally to any of the above embodiments, further comprising a second reinforcement region and a second tension member positioned along the body portion, wherein the second tension member is coupled to the second reinforcement region and the inner shaft.

[0026] Alternatively or additionally to any of the above embodiments, wherein the second tension member is wrapped around the inner shaft.

[0027] An example method of using a balloon catheter includes advancing the balloon catheter to reach a target position through a body vessel. The balloon catheter includes an outer shaft with a distal region and an inner shaft extending in the outer shaft, and the inner shaft has an outer surface, a proximal end, and a distal end. The balloon catheter also includes a balloon, and the balloon includes a distal waist connected to the distal end of the inner shaft, a proximal waist connected to the distal end of the outer shaft, an inner surface, and a wall. The balloon catheter also includes a first internal partition panel disposed in the balloon, wherein the first internal partition panel is connected to both the outer surface of the inner shaft and the inner surface of the balloon. The balloon catheter also includes a second internal partition panel disposed in the balloon, wherein the second internal partition panel is connected to both the outer surface of the inner shaft and the inner surface of the balloon. Additionally, the first internal partition panel is circumferentially spaced away from the second internal partition panel. The method also includes inflating the balloon, whereby the balloon engages the target position, thereby scaling the balloon and withdrawing the balloon catheter from the body vessel.

[0028] 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

[0029] The present invention may be more fully understood by considering the following detailed description taken in conjunction with the accompanying drawings, in which:

[0030] Figure 1 shows a perspective view of an example medical balloon;

[0031] Figure 2A It is along Figure 1 The line 2-2 is intercepted Figure 1 A cross-sectional view of a medical balloon;

[0032] Figure 2B It is along Figure 1 The line 2-2 is intercepted Figure 1 A cross-sectional view of another example embodiment of a medical balloon;

[0033] Figure 3It is along Figure 1 The line 3-3 is intercepted Figure 1 A cross-sectional view of a medical balloon;

[0034] Figure 4 yes Figure 1 A partially exploded view of a medical balloon;

[0035] Figure 5 is in an inflated state Figure 1 A cross-sectional view of a medical balloon;

[0036] Figure 6 It is in zoomed form Figure 1 A cross-sectional view of a medical balloon;

[0037] Figure 7 is a cross-sectional view of another example medical balloon;

[0038] Figure 8 is a cross-sectional view of another example medical balloon;

[0039] Fig. 9 is a stereoscopic view of another example medical balloon;

[0040] Fig.10 It is along Fig. 9 The line 10-10 is intercepted Fig. 9 A cross-sectional view of a medical balloon;

[0041] Fig.11 shows a perspective view of another example medical balloon;

[0042] Fig.12 It is along Fig.11 The line 12-12 is intercepted Fig.11 A cross-sectional view of a medical balloon;

[0043] Fig.13 It is along Fig.11 The line 13-13 is intercepted Fig.11 A cross-sectional view of a medical balloon;

[0044] Fig.14 It is in zoomed form Fig.11 A cross-sectional view of a medical balloon;

[0045] Fig.15 shows a perspective view of another example medical balloon;

[0046] Fig.16 It is along Fig.15 The line 16-16 is intercepted Fig.15 A cross-sectional view of a medical balloon;

[0047] Fig.17 It is in zoomed form Fig.15 Cross-sectional view of a medical balloon. DETAILED DESCRIPTION

[0048] 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.

[0049] 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. In percutaneous transcatheter heart valve replacement (PTVR), a valvuloplasty balloon can be used to replace a diseased native heart valve with an artificial heart valve.

[0050] The valvuloplasty balloon can be introduced into the patient's body by passing through an expandable introducer sheath through which a guidewire is placed. The valvuloplasty balloon can be delivered to a target site by advancing the balloon catheter over the 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. The expanded valvuloplasty balloon can radially expand a narrowed heart valve so that normal blood flow can be restored through the valve.

[0051] In some cases, it may be necessary to utilize a high-pressure valvuloplasty balloon when treating a specific 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 can be constructed with a thicker balloon wall. However, a thicker balloon wall may increase the profile (e.g., outer diameter) of the balloon when it is in a scaled configuration. It is important to minimize the profile of the balloon in the scaled configuration because the profile enables the ease and ability of the valvuloplasty balloon to pass through the introducer sheath, through the coronary arteries and across the narrowed heart valve. In addition, the reduced profile allows the scaled balloon to return through the introducer sheath when the system is removed from the patient. In order to minimize the outer diameter of the balloon in its scaled state, it may be necessary to control the folding / refolding mechanism of the valvuloplasty balloon. The examples disclosed herein may include a valvuloplasty balloon that includes a partition, a tension member, and a reinforcement portion that are designed to control the folding mechanism of the balloon.

[0052] Figure 1An example balloon catheter 10 is shown. The balloon catheter 10 may include an expandable medical balloon 20 mounted on or attached to the distal end of a catheter shaft 30. The medical balloon 20 may be designed for use in various medical procedures, including valvuloplasty. The catheter shaft 30 may extend from and be attached to 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 catheter shaft 30 at the proximal waist 15. It should be understood that the catheter shaft 30 of the balloon catheter 10 can extend through the interior lumen of the balloon 20 and be secured to the distal waist 17 of the balloon 20 .

[0053] The shaft 30 may include a lumen 32. In at least some embodiments, the lumen of the shaft 30 may be a guidewire lumen. Thus, the catheter 10 may be advanced to a desired position over a guidewire. The guidewire lumen 32 may extend substantially along the entire length of the catheter shaft 30, such that the catheter 10 is similar to a conventional "over-the-wire" catheter. Alternatively, the guidewire lumen 32 may extend only along a portion of the shaft 30, such that the catheter 10 is similar to a "single operator exchange" catheter.

[0054] In addition, the shaft 30 can also include one or more, or a plurality of, inflation lumens, which can be used, for example, to deliver an inflation medium to and from the balloon 20. One or more, or a plurality of, inflation lumens can be defined in the space between the outer surface of the guidewire lumen 32 and the inner surface of the shaft 30.

[0055] The balloon 20 may include a balloon wall composed of one or more layers, wherein each of the 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, whereby 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 coextruded during the manufacturing process of the balloon. Typical balloon materials may include polymeric materials, some examples of which are listed herein.

[0056] Additionally, Figure 1The balloon 20 is shown to include one or more internal dividing panels (e.g., radially extending internal fins, ribs, posts, walls, partitions, etc.) that divide the interior of the balloon 20 into a plurality of discrete inflation chambers. For example, the balloon 20 may include one, two, three, four, five, six, seven, eight or more internal dividing panels 22 (e.g., radially extending internal fins, ribs, posts, walls, partitions, etc.) that are circumferentially arranged around the longitudinal axis of the balloon 20. Figure 1 The balloon 20 shown in FIG. 1 includes eight panels 22 (it should be understood that Figure 1 The view hides multiple panels 22).

[0057] In some examples, each of the panels 22 can extend between and be secured to both the shaft 30 and the balloon 20. For example, each of the panels 22 can include a first end or first longitudinal extent that is attached to the outer surface of the shaft 30. Additionally, each of the panels 22 can include a second end or second longitudinal extent that is attached to the inner surface of the balloon 20 along the distal tapered region 16, the body portion 12, and the proximal tapered region 14. As will be described with respect to Figure 2A and Figure 2B Described in more detail, it should be understood that the shaft 30, the balloon 20, and any two adjacent interior dividing panels 22 can define an interior chamber 24 positioned between adjacent panels 22. In other words, each panel 22 can be sealed along the outer surface of the shaft 30 and along the inner surface of the balloon 20, such that each chamber 24 defines a separate and distinct inflation area of ​​the balloon 20. Each distinct inflation chamber 24 can be fluidically isolated from one or more of the other inflation chambers 24 within the balloon 20. For example, in some cases, each distinct inflation chamber 24 can be fluidically isolated from each of the other inflation chambers 24 within the balloon 20.

[0058] In some examples, the manifold attached to the outer shaft 20 can be configured to allow for selective inflation of one or more of the chambers 24. In other words, the balloon catheter 10 can include a manifold that allows each chamber 24 to be inflated independently of one or more of the other chambers 24. In some cases, the balloon catheter 10 can include a manifold that allows for each chamber 24 to be inflated independently of each of the other chambers 24. Thus, in the event that a single chamber 24 fails to inflate, one or more of the other chambers 24 can still be inflated despite the failure of the single chamber 24 to inflate.

[0059] Figure 2A It is along Figure 1 The line 2-2 is intercepted Figure 1 Cross-sectional view of a medical balloon. Figure 2AThe inner dividing panels 22 are shown disposed circumferentially around the outer surface of the shaft 30. Each of the panels 22 may include a first end or first extent that is attached to the outer surface of the shaft 30, and may also include a second end or second extent that is attached to the inner surfaces of the distal tapered region 16, the body portion 12, and the proximal tapered region 14. It should be understood that each of the panels 24 may be an integral structure connected between the shaft 30 and the balloon 20, extending radially outward from the outer surface of the shaft 30 to the inner surface of the balloon 20, thereby forming individual panels (e.g., walls, ribs, etc.) that are circumferentially spaced apart from each other, as described herein.

[0060] Additionally, Figure 2A The catheter shaft 30 is shown to further include a plurality of inflation lumens defined between one or more rib members 33 that extend longitudinally from a distal region of the catheter shaft 30 to a manifold that can be attached to the proximal end of the catheter shaft 30. It should be understood that each of the rib members 33 can establish a plurality of different inflation lumens. For example, Figure 2A It is shown that the rib members 33 can divide the catheter shaft 30 into eight separate and distinct inflation lumens.

[0061] As mentioned above, Figure 2A It is shown that any two adjacent panels 22 may define different inflation chambers positioned between the two adjacent panels 22 . Figure 2A It is also shown that the balloon 20 can include a plurality of holes 26 that are in fluid communication with one or more different inflation lumens of the catheter shaft 30. For example, the catheter can include at least one hole 26 located in each of the different inflation lumens, whereby the at least one hole 26 can be in fluid communication with each of the inflation chambers 24, thereby allowing inflation fluid to enter the corresponding inflation chamber 24 from the inflation lumen of the catheter shaft 30. The holes 26 can be circumferentially aligned with each of the inflation chambers 24, such that the holes 26 can allow inflation medium (e.g., inflation fluid) to enter the inflation chamber 24 from the inflation lumen. As described above, the balloon catheter 10 can include 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 the corresponding inflation chambers 24, which allows one or more of the chambers 24 to be independently inflated via the manifold. As discussed above, each inflation chamber 24 can be in fluid communication with a separate dedicated inflation lumen extending through the catheter shaft 30. Thus, in the event that a single chamber 24 fails to inflate, one or more other chambers 24 may still be inflated despite the failure of the single chamber 24 to inflate.

[0062] Figure 2Bis a cross-sectional view of another example medical balloon catheter 10'. The medical balloon catheter 10' can be similar in form and function to the medical balloon catheter 10 described above. For example, the medical balloon catheter 10' can include a catheter shaft 30 positioned within the balloon body portion 12, as described above. In addition, Figure 2B The cross-sectional view shown shows that the balloon 20 can include one or more internal dividing panels 22' spaced circumferentially around the outer surface of the catheter shaft 30, which divide the balloon 20 into a plurality of discrete inflation chambers 24. Each distinct inflation chamber 24 can be fluidly isolated from one or more of the other inflation chambers 24 within the balloon 20. For example, in some cases, each distinct inflation chamber 24 can be fluidly isolated from each of the other inflation chambers 24 within the balloon 20.

[0063] The internal dividing panels 22' can be similar in form and function to the internal panels 22 described herein. Each of the panels 22' can extend between and be secured to both the shaft 30 and the wall of the balloon 20. For example, each of the panels 22' can include a first end or first extent that is attached to the outer surface of the catheter shaft 30, and can also include a second end or second extent that is attached to the inner surfaces of the proximal tapered region 14, the body portion 12, and the distal tapered region 16. It should be understood that each of the panels 22' can be a unitary structure that extends radially outward from the outer surface of the catheter shaft 30 to the inner surfaces of the proximal tapered region 14, the body portion 12, and the distal tapered region 16, thereby forming individual panels 22' (e.g., fins, ribs, posts, walls, partitions, etc.) that are circumferentially spaced apart from each other, as described herein.

[0064] also, Figure 2B The balloon 20 is shown to include a plurality of holes 26 that are in fluid communication with one or more inflation lumens of the balloon catheter 10. For example, the catheter 10 may include at least one hole 26 in fluid communication with each of the inflation chambers 24, thereby allowing inflation fluid to enter the corresponding inflation chamber 24 from the inflation lumen of the catheter shaft 30. The holes 26 may be circumferentially aligned with each of the inflation chambers 24, such that the holes 26 may allow an inflation medium (e.g., inflation fluid) to enter the inflation chamber 24 from the inflation lumen. As described above, the balloon catheter 10 may include a manifold that allows each chamber 24 to be inflated independently of one or more of the other chambers 24. In some cases, the balloon catheter 10 may include a manifold that allows each chamber 24 to be inflated independently of each of the other chambers 24. For example, the balloon catheter 10' may include one or more independent inflation lumens that allow one or more of the chambers 24 to be independently inflated via the manifold. Thus, in the event that a single chamber 24 fails to inflate, one or more other chambers 24 may still be inflated despite the failure of the single chamber 24 to inflate.

[0065] Figure 2B It is also shown that one or more of the panels 22' can extend from the outer surface of the catheter shaft 30 at an angle, so that the plurality of panels 22' can form an iris-type formation around the catheter shaft 30. For example, Figure 2B The detailed view of shows that each of the panels 22 ′ may form an acute angle θ with respect to a tangent line 34 passing through the attachment point 36 of the panel 22 ′ to the outer surface of the catheter shaft 30 .

[0066] Figure 3 It is along Figure 1 A cross-sectional view of the medical balloon catheter 10 taken along line 3-3. Figure 3 Two inner dividing panels 22 are shown, which are circumferentially offset from each other by 180 degrees. As described herein, each of the panels 22 may include a first longitudinal extent that is attached to the outer surface of the catheter shaft 30 (e.g., a first edge of each of the panels is attached to the outer surface of the catheter shaft 30 and extends longitudinally thereof). Additionally, each of the panels 22 may include a second longitudinal extent that is attached to the inner surface of the balloon 20 and extends along the proximal tapered region 14, the body portion 12, and the distal tapered region 16 (e.g., a second edge of each of the panels is attached to the inner surface of the proximal tapered region 14, the body portion 12, and the distal tapered region 16 and extends longitudinally thereof).

[0067] Additionally, as described herein, Figure 3 The catheter shaft 30 is shown to include a plurality of holes 26 that are in fluid communication with one or more inflation lumens of the balloon catheter 10. FIG. 2A to FIG. 2B As shown, one or more of the holes 26 may be circumferentially aligned with each of the inflation chambers 24 defined by any two adjacent panels 22. Figure 3 The holes 26 are shown to also extend along the longitudinal axis of the balloon 20, such that a plurality of longitudinally aligned holes 26 are in fluid communication with each of the inflation chambers 24. Thus, each individual inflation chamber 24 (defined between any two panels 22) can be inflated via a plurality of holes 26 that are aligned with each other along the longitudinal axis of the balloon 20.

[0068] Figure 4 An exploded view of the various components of the balloon catheter 10 is shown. For example, Figure 4 The catheter shaft 30, a plurality of circumferentially spaced apart interior dividing panels 22, and a portion of the body 12 of the balloon 20 are shown. Figure 4 It is shown that a plurality of internal dividing panels 22 can be evenly spaced from one another around the circumference of the catheter shaft 30. Thus, Figure 4 The balloon catheter 10 is shown to include eight panels 22 (in Figure 42 (a single panel 22 is hidden from view in FIG. 2 ), which defines eight inflation chambers 24 (a single inflation chamber 24 is defined between two adjacent panels 22). In some examples, the balloon catheter 10 may include less than or more than eight partition panels 22. For example, the balloon catheter 10 may include 2, 3, 4, 5, 6, 7, 8, 9, 10 or more partition panels and associated inflation chambers. Figure 4 It is also shown that each of the panels 22 can include an outermost edge (in some cases, referred to herein as a second extent) that is configured to match the shape (e.g., contour, geometry, etc.) of the inner surface of the balloon 20. Figure 4 It should be understood that each of the panels 22 may be shaped to correspond to Figure 1 The inner surfaces of the proximal cone 14, the body portion 12, and the distal cone 16 of the balloon 20 are shown to match and form a seal therewith. In some cases, the panel 22 can be formed integrally with the body portion 12, so that the panel 22 is an integral structure of the body portion 12 of the balloon 20. In other cases, the panel 22 can be formed separately and then secured to the body portion 12 of the balloon 20.

[0069] In some examples, the balloon catheter 10 described herein can be constructed by extruding the internal split panel 22, together with the extruded balloon 20. It should be understood that to complete the construction of the balloon catheter 10, the catheter shaft 30 can then be inserted into the center of the panel 22, whereby each of the panels 22 is attached (via any suitable attachment technique, including but not limited to adhesive bonding, laser welding, etc.) to the outer surface of the catheter shaft 30. In other manufacturing methods, each of the panels 22 can be individually attached to the outer surface of the catheter shaft 30 to form a catheter shaft / panel subassembly, whereby the catheter shaft / panel subassembly is then inserted and attached to the inner surface of the balloon 20. In other manufacturing methods, each of the panels 22 can be attached (via any suitable attachment technique, including but not limited to adhesive bonding, laser welding, etc.) to the inner surface of the balloon and then attached to the catheter shaft 30. In addition, in some examples, a channel can be formed along the inner surface of the balloon, and the panel 22 can be positioned in the channel. After the panel 22 is positioned in the channel, the balloon and the panel 22 can be thermally bonded together.

[0070] Figure 4 The detailed view of shows that the catheter shaft 30 can include one or more of the holes 26 that are circumferentially aligned with each of the inflation chambers 24 defined by any two adjacent panels 22 of the balloon 20. In addition, Figure 4The holes 26 are shown to also extend along the longitudinal axis of the catheter shaft 30, such that a plurality of longitudinally aligned holes 26 are in fluid communication with each of the inflation chambers 24. Thus, each individual inflation chamber 24 (defined between any two panels 22) can be inflated via a plurality of holes 26 that are aligned with each other along the longitudinal axis of the balloon 20.

[0071] Figure 5 A cross-sectional view of the balloon 20 of the balloon catheter 10 is shown, wherein an inflation medium (eg, inflation fluid) is delivered through the plurality of inflation lumens of the catheter 10 , passing through the apertures 26 and inflating corresponding chambers 24 defined between adjacent panels 22 . Figure 5 Arrows 38 show the flow of inflation fluid from the inflation lumen into each chamber 24. As described herein, it should be understood that in some examples, the balloon catheter 10 may include a manifold configured to allow selective inflation of one or more of the inflation chambers 24. Thus, in the event that one or more inflation chambers 24 fail to inflate, the remaining chambers 24 may continue to be inflated.

[0072] Figure 5 It is also shown that during inflation of the balloon 20, each individual panel 22 can be configured such that the panel prevents a portion of the wall of the balloon 20 from extending radially outward. Figure 5 As depicted, when the balloon 20 is inflated, the portion of the balloon wall extending between any two panels 22 can bulge radially outward beyond the radial extent of each panel 22. It should be understood that, when inflated, the balloon 20 material positioned between any two points to which the balloon material is attached can define the maximum radial extent of the balloon 20. In other words, it should be understood that during inflation, each of the panels 22 can be sufficiently strong to withstand the radial inflation force of the balloon 20, and thus each of the panels 22 can prevent a portion of the balloon 20 directly radially outward of the corresponding panel 22 from expanding radially outward, and thereby allow the portion of the balloon 20 positioned 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. This configuration can provide a balloon 20 having a plurality of longitudinal grooves or valleys arranged around the outer circumference of the balloon 20 between adjacent longitudinal ridges or peaks.

[0073] Figure 6 The diagram shows the balloon 20 after a vacuum (ie, negative pressure) has been drawn to deflate it. Figure 5 The balloon 10 is shown. It will be appreciated that the walls of the balloon 20 may be drawn onto each of the panels 22 and / or drawn inwardly against the panels 22 when a vacuum is drawn on the inflation medium. Figure 6It is shown that the panels 22 can be constructed with sufficient column strength to maintain their relative shapes despite radial collapse of the balloon 20 onto the panels 22. It should also be understood that designing the panels 22 to have sufficient column strength to maintain their relative shapes during scaling of the balloon 20 can result in the balloon 20 having a predictable, scaled cross-sectional shape.

[0074] like Figure 6 As shown, the cross-sectional shape of the scaled balloon 20 forms a relatively uniform distribution of balloon material, whereby in the scaled configuration, a substantially uniform amount of balloon material is positioned along each of the panels 22. Furthermore, it should be appreciated that the uniform distribution of balloon material along the panels 22 can allow the balloon 20 to be refolded in a more efficient, symmetrical, and uniform configuration. In other words, the configuration of the panels 22 and the subsequent scaled configuration of the balloon 20 (e.g., Figure 6 ) can facilitate a refolded balloon 20 that includes a reduced outer profile (eg, reduced overall outer diameter) in the collapsed configuration. It should be appreciated that the reduced outer profile can be beneficial during withdrawal of the collapsed balloon 20 into the introducer sheath.

[0075] Figure 7 is a cross-sectional view of another example medical balloon catheter 10 ″. The medical balloon catheter 10 ″ can be similar in form and function to the medical balloon catheter 10 described above. For example, the medical balloon catheter 10 ″ can include a catheter shaft 30 positioned within the balloon body portion 12, as described herein. In addition, Figure 7 The balloon 20 is shown to include one or more internal dividing panels 22" spaced about the catheter shaft 30 that divide the balloon 20 into a plurality of discrete inflation chambers 24. Each distinct inflation chamber 24 can be fluidly isolated from one or more of the other inflation chambers 24 within the balloon 20. For example, in some cases, each distinct inflation chamber 24 can be fluidly isolated from each of the other inflation chambers 24 within the balloon 20.

[0076] The internal dividing panels 22" can be similar in form and function to the internal panels 22 described herein. Each of the panels 22" can extend between and be secured to both the catheter shaft 30 and the wall of the balloon 20. For example, each of the panels 22" can include a first end or first range that is attached to the outer surface of the catheter shaft 30, and can also include a second end or second range that is attached to the inner surface of the balloon 20 (along the proximal tapered region 14, the main body portion 12, and the distal tapered region 16). It should be understood that each of the panels 22" can be an integral structure that extends radially outward from the outer surface of the catheter shaft 30 to the inner surface of the balloon 20, thereby forming panels 22" (e.g., fins, ribs, columns, walls, partitions, etc.) that are circumferentially spaced apart from each other, as described herein.

[0077] also, Figure 7 The catheter shaft 30 is shown to include a plurality of holes 26 that are in fluid communication with one or more inflation lumens of the catheter 10 ″. For example, the catheter 10 ″ may include at least one hole 26 in fluid communication with each of the inflation lumens 24, thereby allowing inflation fluid to enter the corresponding inflation lumen 24 from the inflation lumen of the catheter 10 ″. Figure 7 As shown, the holes 26 can be circumferentially aligned with each of the inflation chambers 24 defined by any two adjacent panels 22". The holes 26 can be circumferentially aligned with each of the inflation chambers 24, so that the holes 26 can allow an inflation medium (e.g., an inflation fluid) to enter the inflation chamber 24 from the inflation cavity of the balloon catheter 10". As described above, the balloon catheter 10" can include a manifold that allows each chamber 24 to be inflated independently of one or more of the other chambers 24. In some cases, the balloon catheter 10" can include a manifold that allows each chamber 24 to be inflated independently of each of the other chambers 24.

[0078] Figure 7 Also shown is a balloon catheter 10" that may include an internal dividing panel 22" disposed about the catheter shaft 30 to form three different inflation chambers 24. Figure 7 As shown, the panels 22" can be arranged around 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 different sizes than the other chambers 24). For example, Figure 7 It is shown that the balloon catheter 10" may be designed to include three panels 22" distributed about the catheter shaft 30 in a configuration that defines two inflation chambers 24 of substantially uniform size and a third inflation chamber 24 that is larger than each of the other inflation chambers 24 of uniform size.

[0079] Figure 8 is a cross-sectional view of another example medical balloon catheter 10''. The medical balloon catheter 10'' can be similar in form and function to the medical balloon catheter 10 described above. For example, the medical balloon catheter 10'' can include a catheter shaft 30 positioned within the balloon body portion 12, as described above. In addition, Figure 8 The cross-sectional view shown shows that the balloon 20 can include one or more internal dividing panels 22'" spaced apart around the outer surface of the catheter shaft 30, which divide the balloon 20 into a plurality of discrete inflation chambers 24. Each distinct inflation chamber 24 can be fluidly isolated from one or more of the other inflation chambers 24 within the balloon 20. For example, in some cases, each distinct inflation chamber 24 can be fluidly isolated from each of the other inflation chambers 24 within the balloon 20.

[0080] The internal dividing panels 22'" can be similar in form and function to the internal panels 22 described herein. Each of the panels 22'" can extend between and be secured to both the catheter shaft 30 and the wall of the balloon 20. For example, each of the panels 22'" can include a first end or first range that is attached to the outer surface of the catheter shaft 30, and can also include a second end or second range that is attached to the inner surface of the balloon 20 (along the proximal tapered region 14, the body portion 12, and the distal tapered region 16). It should be understood that each of the panels 22'" can be a unitary structure that extends radially outward from the outer surface of the catheter shaft 30 to the inner surface of the balloon 20, thereby forming individual panels 22'" (e.g., fins, ribs, columns, walls, partitions, etc.) that are circumferentially spaced apart from each other, as described herein.

[0081] Figure 8 The catheter shaft 30 is shown to include a plurality of holes 26 that are in fluid communication with one or more inflation lumens of the balloon catheter 10 ″′. For example, the catheter 10 ″′ may include at least one hole 26 in fluid communication with each of the inflation chambers 24, thereby allowing inflation fluid to enter the corresponding inflation chamber 24 from the inflation lumen 32 of the catheter 10 ″′. Figure 8 As shown, the holes 26 can be circumferentially aligned with each of the inflation chambers 24 defined by any two adjacent panels 22'". The holes 26 can be circumferentially aligned with each of the inflation chambers 24, so that the holes 26 can allow an inflation medium (e.g., an inflation fluid) to enter the inflation chamber 24 from the inflation lumen of the balloon catheter 10'". As described above, the balloon catheter 10'" can include a manifold that allows each chamber 24 to be inflated independently of one or more of the other chambers 24. In some cases, the balloon catheter 10'" can include a manifold that allows each chamber 24 to be inflated independently of each of the other chambers 24.

[0082] Figure 8 The balloon catheter 10'' is also shown to include internal dividing panels 22'' that divide the interior of the balloon 20 into a plurality of inflation chambers 24, whereby one or more of the internal dividing panels 22'' extend a greater distance away from the catheter shaft 30 than one or more of the other internal dividing panels 22''. In other words, one or more of the dividing panels 22'' can have a greater radial height than the other of the dividing panels 22''. Figure 8 In the example of FIG. 1 , one or more of the partition panels 22 ″′ extend a greater distance away from the outer surface of the catheter shaft 30 than the other panels 22 ″′. Figure 8 It should be understood that this configuration causes the central longitudinal axis of the catheter shaft 30 to deviate from the central longitudinal axis of the balloon 20. In addition, Figure 8It is shown that the inflation chambers 24 (defined by adjacent panels 22'") can all have different sized configurations. For example, Figure 8 It is shown that the balloon 10'" may be designed to include six panels 22'" whereby each of the panels 22'" has a different radial extent and is distributed about the catheter shaft 30 in a configuration defining six inflation chambers 24 having different sizes relative to each other.

[0083] Fig. 9 Another example balloon catheter 100 is shown. The balloon catheter 100 may include an expandable medical balloon 120 mounted on or attached to a distal end of a catheter shaft, such as an outer catheter shaft 130. The medical balloon 120 may be designed for various medical procedures, including valvuloplasty. The catheter shaft 130 may extend from and be attached to a manifold assembly (not shown) positioned at the proximal end of the catheter shaft 130. The balloon 120 may 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 may 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 secured to the outer catheter shaft 130 at the proximal waist 115. It should be understood that the catheter shaft 130 of the balloon catheter 110 can extend through the interior of the balloon 120 and be secured to the distal waist 117 of the balloon 120.

[0084] Fig. 9 It is also shown that the medical balloon 120 can include one or more internal dividing panels 122 (e.g., radially extending internal fins, ribs, columns, walls, partitions, etc.) that are circumferentially arranged around the longitudinal axis of the balloon 120 and divide the interior of the balloon 120 into a plurality of discrete inflation chambers. The panels 122 can be similar in form and function to the panels 22 described herein. For simplicity, Fig. 9 The catheter 100 is shown to include two panels 122. However, it should be understood that the balloon 120 may include one, two, three, four, five, six, seven, eight or more panels 122. For example, to Fig. 9 A cross-sectional view of the balloon catheter 100 taken along line 10-10 Fig.10 The balloon 120 is shown to include eight internal dividing panels 122, 125a, 125b, 125c, 125d (e.g., radially extending internal fins, ribs, posts, walls, partitions, etc.) that are arranged circumferentially around the longitudinal axis of the balloon 120.

[0085] Similar to what is described herein with respect to the panels 22 of the balloon 20, each of the panels 122 may include a first end or first longitudinal extent that is attached to the outer surface of the catheter shaft 130. Additionally, each of the panels 122 may include a second end or second longitudinal extent that is attached to the inner surface of the balloon 120 and extends along the distal tapered region 116, the body portion 112, and the proximal tapered region 114. Thus, as Fig.10 As shown, it should be understood that any two adjacent internal dividing panels 122 can define an internal chamber 124 positioned between the adjacent panels 122. In other words, each panel 122 can be sealed along the outer surface of the catheter shaft 130 and along the inner surfaces of the distal tapered region 116, the body portion 112, and the proximal tapered region 114, so that each chamber 124 defines a separate and distinct inflation region of the balloon 120. Each distinct 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 cases, each distinct inflation chamber 124 can be fluidly isolated from each of the other inflation chambers 124 within the balloon 120.

[0086] also, Figures 9 and 10 The example balloon 120 is shown to include one or more panels 122a, 122b, 122c, 122d having a proximal region 152a, 152b, 152c, 152d that is not attached to the outer surface of the catheter shaft 130. For example, Fig. 9 Panel 122 is shown including a proximal region 125 ( Fig. 9 The panel 122 is shown unattached to the outer surface of the catheter shaft 130 between the attachment point 127 and the proximal end 140 of the proximal region 125 of the panel 122).

[0087] As mentioned above, Fig.10 An inner dividing panel 122 is shown disposed circumferentially about the outer surface of the conduit 130 . Fig.10 It is shown that any two adjacent panels 122 may define a different inflation chamber 124 positioned between the two adjacent panels 122 . Fig.10Also included are a plurality of apertures 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 aperture 126 in fluid communication with each of the inflation chambers 124, thereby allowing inflation fluid to enter the corresponding inflation chamber 124 from the inflation chamber of the catheter 100. The apertures 126 can be circumferentially aligned with each of the inflation chambers 124, such that the apertures 126 can allow an inflation medium (e.g., inflation fluid) to enter the inflation chamber 124 from the inflation chamber. As described herein, the balloon catheter 100 can include a manifold that allows each chamber 124 to be inflated independently of the other chambers 124. For example, similar to that described above with respect to the catheter 10, the balloon catheter 100 can include one or more independent inflation chambers in fluid communication with the corresponding inflation chambers 124, allowing one or more of the chambers 124 to be independently inflated via the manifold. Thus, each inflation chamber 124 can be in fluid communication with a separate dedicated inflation chamber extending through the catheter shaft. Thus, in the event that a single chamber 124 fails to inflate, one or more other chambers 124 may still be inflated despite the failure of the single chamber 124 to inflate.

[0088] Fig.10 Also shown is a proximal region 125 of the panel 122 that is not attached to the outer surface of the catheter shaft 130 . Fig.10 A gap 152 is shown radially between the panel 122 and the outer surface of the catheter shaft 130. It should be understood that when the balloon 120 is inflated, the balloon wall adjacent the proximal region 125 of the panel 122 (at Fig.10 Portions of the balloon wall (depicted as an "X" in the figure) can expand radially outward to a greater extent than other portions of the balloon wall (e.g., portions of the balloon 120 in the unattached proximal region 125 adjacent to the panel 122 expand radially outward without restraint compared to portions of the balloon 120 connected to the attachment panel 122).

[0089] With respect to the holes of any of the foregoing embodiments, the plurality of holes 26, 126 in communication with any of the chambers 24, 124 may be longitudinally equidistantly arranged along the catheter shaft 30, 130, or the holes 26, 126 may be longitudinally arranged in other ways. For example, there may be more holes 26, 126, holes 26, 126 of larger size (e.g., larger diameter), and / or holes 26, 126 that are more closely arranged closer to the distal end of the catheter shaft, and therefore, in some cases, closer to the distal region of the chamber 24, 124. This configuration may help inflate the distal region of the balloon 20, 120 relative to the proximal region of the balloon 20, 120. In other cases, there may be more holes 26, 126, holes 26, 126 of larger size (e.g., larger diameter), and / or holes 26, 126 that are more closely arranged closer to the proximal end of the catheter shaft, and therefore, in some cases, closer to the proximal region of the chamber 24, 124. This configuration can help inflate the proximal region of the balloon 20, 120 relative to the distal region of the balloon 20, 120. In other cases, there can be more pores 26, 126, pores 26, 126 of larger size (e.g., larger diameter), and / or pores 26, 126 that are more closely spaced along the middle region of the chamber 24, 124 relative to the proximal and distal regions of the chamber 24, 124 in some cases. This configuration can help inflate the middle region of the balloon 20, 120 relative to the proximal and distal regions of the balloon 20, 120.

[0090] Fig.11 An example balloon catheter 200 is shown. The balloon catheter 200 may include an expandable medical balloon 220 mounted on or attached to a distal end of a catheter shaft, such as an outer catheter shaft 230. The medical balloon 220 may be designed for use in various medical procedures, including valvuloplasty. The catheter shaft 230 may extend from and be attached to a manifold assembly (not shown) positioned at the proximal end of the catheter shaft 230. The balloon 220 may also include a body portion 212, a proximal tapered portion 214, a distal tapered portion 216, a proximal waist portion 215, and a distal waist portion 217. The body portion 212 may be positioned between the proximal tapered portion 214 and the distal tapered portion 216, wherein the proximal waist portion 215 extends proximally of the proximal tapered portion 214, and the distal waist portion 217 extends distally of the distal tapered portion 216. The balloon 220 can be secured to the outer catheter shaft 230 at the proximal waist 215. It should be understood that the catheter shaft of the balloon catheter 200 can also include an inner shaft 232 that can extend within the outer catheter shaft 230, through the interior lumen of the balloon 220 and secured to the distal waist 217 of the balloon 220.

[0091] The inner shaft 232 may include an inner lumen. In at least some embodiments, the inner lumen of the inner shaft 232 may be a guidewire lumen. Therefore, the catheter 200 may be advanced to a desired position over a guidewire. The guidewire lumen may extend substantially along the entire length of the catheter shaft 230, so that the catheter 200 is similar to a traditional "on-the-wire" catheter. Alternatively, the guidewire lumen may extend only along a portion of the shaft 230, so that the catheter 200 is similar to a "single operator exchange" catheter.

[0092] In addition, the outer shaft 230 can also include an inflation lumen, which can be used, for example, to deliver an inflation medium to and from the balloon 220. When the outer shaft 230 is disposed on the inner shaft 232, the inflation lumen can be defined in a space between an outer surface of the inner shaft 232 and an inner surface of the outer shaft 230.

[0093] The balloon 220 may include a balloon wall composed of one or more layers, wherein each of the layers may be composed of different balloon materials. For example, the balloon wall 224 of the balloon 220 may include an inner layer and an outer layer, whereby 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 224 may be coextruded during the manufacturing process of the balloon. Typical balloon materials may include polymeric materials, some examples of which are listed herein.

[0094] In addition, if Fig.11 As shown, balloon 220 can include one or more longitudinally extending reinforcement portions arranged around the circumference of balloon 220. For example, balloon 220 can include one, two, three, or more reinforcement portions arranged circumferentially around the longitudinal axis of balloon 220. Fig.11 The balloon 220 shown includes three reinforcement parts 222a, 222b, and 222c. The reinforcement part 222c is Fig.11 Hidden in Figure 13 to Figure 14 Shown in.

[0095] In some examples, the reinforcing portions 222a, 222b, 222c may include one or more interwoven (e.g., braided, woven, or knitted) filaments 234 that are attached to and / or embedded in the inner surface of the balloon 220. The filaments 234 may be made of a variety of materials. For example, the filaments 234 may be made of silk, fibers (e.g., Fiber), silk or other suitable material. In other examples, the reinforcing portions 222a, 222b, 222c may include a continuous, flexible strip of material attached to and / or embedded in the inner surface of the balloon 220. However, in other examples, the reinforcing portions 222a, 222b, 222c may include a polyimide strip, a liquid crystal polymer, or other similar material.

[0096] In some examples, Fig.11 Each of the reinforcement portions 222a, 222b, 222c in the balloon 220 may each include one or more braided or interwoven filaments 234 disposed along the inner surface of the balloon 220. In some examples, the filaments 234 may be braided, wound, wrapped, woven, etc. in various forms along each of the reinforcement portions 222a, 222b, 222c of the balloon 220. For example, the filaments 234 may be directly attached to the inner surface of the balloon 220. However, in other examples, the filaments 234 may be extruded with the balloon material so that the filaments 234 are partially embedded in the wall 224 of the balloon 220. However, in other examples, the filaments 234 may be extruded with the balloon material so that the filaments 234 are completely embedded in the wall 224 of the balloon 220. Alternatively, it should be understood that the filaments 234 may be adhesively bonded to the inner surface of the balloon 220. The adhesive may include a thermosetting adhesive that cures via a chemical reaction or radiation. In some examples, a polymer coating may be applied to balloon 220 .

[0097] Fig.11 It is also shown that the catheter 200 may also include one, two, three or more tension members 226a, 226b, 226c (e.g., tethers) attached to the reinforcement portions 222a, 222b, 222c of the balloon 220 and located inside the balloon 220. For example, Fig.11 The catheter 200 is shown to include a first tension member 226a located inside the balloon 220, which has a first end attached to the first end of the reinforcement portion 222a and a second end attached to the second end of the reinforcement portion 222a. Fig.11 As shown, the portion of the tension member 226a extending between the first end and the second end of the tension member 226a can be wrapped around the inner shaft 232 (e.g., helically wrapped around it). Fig.11 The catheter 200 is shown to include a second tension member 226b located inside the balloon 220, which has a first end attached to the first end of the reinforcement portion 222b and a second end attached to the second end of the reinforcement portion 222b. Fig.11 As shown, the portion of the tension member 226b extending between the first end and the second end of the tension member 226b can be wrapped around the inner shaft 232 (e.g., helically wrapped around it). As discussed herein, the reinforcement portion 222c is Fig.11 is hidden from view, however, Fig.11Indeed, a tension member 226c is shown wrapped around (helically wrapped around) the inner shaft 232. In some examples, the inner member can include a reinforcing wire (e.g., a braid, a mesh, etc.). The reinforcing wire can define one of the multiple layers of the inner shaft 232. Furthermore, in some examples, one or more of the tension members 226a, 226b, 226c can be integrated with the reinforcing wire of the inner shaft 232. In other words, in some examples, the tension members 226a, 226b, 226c can be combined with one or more additional wires to form a reinforced wire braid in the wall of the inner shaft 232.

[0098] Furthermore, it should be understood that tension member 226c can be located within balloon 220 and include a first end attached to a first end of reinforcement portion 222c and a second end attached to a second end of reinforcement portion 222c. Figure 13 to Figure 14 Reinforcement portion 222c and tension member 226c are shown in FIG.

[0099] Fig.12 It is along Fig.11 A cross-sectional view of the balloon 220 taken along line 12-12 of FIG. As described herein, Fig.12 Reinforced portions 222a, 222b are shown extending longitudinally along the body portion 212 of the balloon 220 (reinforced portion 222c is hidden from view). Fig.12 The detailed view of FIG. 2 shows the filaments 234 disposed along the inner surface of the balloon wall 224. As discussed herein, the braided or interwoven filaments 234 can be disposed directly on the inner surface of the balloon wall 224 (e.g., the braided or interwoven filaments 234 can be directly attached to the inner surface of the balloon wall 224). However, in other examples, the filaments 234 can be partially or completely embedded in the balloon wall 224 (via an extrusion process or other suitable manufacturing method).

[0100] As discussed in this article, Fig.12 A first tension member 226a is shown having a first end attached to a first end of the reinforcement portion 222a and a second end attached to a second end of the reinforcement portion 222a. The portion of the tension member 226b extending between the first and second ends inside the balloon 220 can be wrapped around the inner shaft 232. Fig.12 Also shown is a second tension member 226b having a first end attached to the first end of the reinforcing portion 222b and a second end attached to the second end of the reinforcing portion 222b. Fig.12 As shown, the portion of the tension member 226b extending between the first and second ends of the interior of the balloon 220 can be wrapped around the inner shaft 232.

[0101] Additionally, Fig.12Detailed view of the first tension member 226a shows that the first end 242 of the first tension member 226a can be attached or fixed 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 first tension member 226a can be attached or fixed 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 first tension member 226a can be embedded in the reinforcement portion 222a, and the second end portion 243 of the first tension member 226a can be embedded in the reinforcement portion 222a. In other cases, for example, the first end portion 242 of the first tension member 226a can be adhesively bonded to the reinforcement portion 222a, and the second end portion 243 of the first tension member 226a can be adhesively bonded to the reinforcement portion 222a. In other examples, the first tension member 226a can extend along the entire length of the reinforcement portion 222a. In other words, in some examples, the first tension member 226a can form a loop, whereby 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 reinforcement portion 222a. Similarly, the second tension member 226b can extend along the entire length of the reinforcement portion 222b. In other words, in some examples, the second tension member 226b can form a loop, whereby 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 reinforcement portion 222b.

[0102] It should be understood that attaching the first end portion 242 and the second end portion 243 of the first tension member 226a to the reinforcement portion 222a may include passing the braided or interwoven filaments 234 over and / or under the first end portion 242 and the second end portion 243 of the first tension member 226a, thereby securing the first tension member 226a to each of the reinforcement portions 222a. It should also be understood that the second tension member 226b and the third tension member 226c may be attached to the second reinforcement portion 222b and the third reinforcement portion 226c, respectively, using the same attachment method as described for attaching the first tension member 226a to the first reinforcement portion 222a.

[0103] In some examples, the tension members 226a, 226b, 226c may be made of high-strength fibers (e.g., fiber, fiber, Fiber), filament, silk, nylon or other suitable materials. In other examples, tension members 226a, 226b, 226c may include elastic members. In addition, each of tension members 226a, 226b, 226c may be designed to apply radially inward force to each of reinforcing portions 222a, 222b, 222c when the balloon is scaled. Applying radially inward force to each of reinforcing portions 222a, 222b, 222c when the balloon is scaled may cause the balloon to refold (e.g., rewind) in a reduced outer profile before the balloon 220 is withdrawn into the introducer sheath. In other words, applying radially inward force to each of reinforcing portions 222a, 222b, 222c when the balloon is scaled may help form a refolded balloon 220 that includes a reduced outer profile in the scaled configuration. It should be understood that the reduced outer profile may be beneficial during the withdrawal of the scaled balloon 220 into the introducer sheath. Figure 13 to Figure 14 A mechanism is shown that applies an inward radial force to the balloon 220 to refold the balloon 220 as discussed above.

[0104] Fig.13 Shown along Fig.12 13 - 13 is a cross-sectional view of balloon 220 taken along line 13 - 13 , wherein balloon 220 is inflated. Fig.13 Three longitudinally extending reinforcement portions 222a, 222b, 222c are shown arranged circumferentially about the inner shaft 232. Fig.13 It is shown that the three reinforcing portions 222a, 222b, 222c can be equally spaced around the inner shaft 232. However, in other examples, the three reinforcing portions 222a, 222b, 222c can be unequally spaced around the inner shaft 232. As discussed herein, the balloon 220 can include one, two, three, four, five, six, or more longitudinally extending reinforcing portions (e.g., 222a, 222b, 222c) arranged around the inner shaft 232.

[0105] Fig.13 Also shown are braided or interwoven filaments 234 of each of the reinforcement portions 222a, 222b, 222c disposed along the inner surface of the balloon 220. Fig.13It will be appreciated that circumferential portions of the balloon wall 224 extend between each of the reinforcement portions 222a, 222b, 222c, thereby establishing discrete areas of continuous balloon wall 224 that are free of filaments 234 and / or reinforcement portions. In some instances, when fully inflated, the circumferential areas of the balloon wall 224 that are free of filaments 234 and / or reinforcement portions 222a, 222b, 222c may extend radially outward to a greater extent than the portions of the balloon wall 224 that extend directly outward and are secured to the reinforcement portions 222a, 222b, 222c. Although Fig.13 Three reinforcement portions 222a, 222b, 222c (each of which includes filaments 234) are shown disposed along the inner surface of the balloon 220, but it is contemplated that in some examples, the braided or interwoven filaments 234 of each reinforcement portion 222a, 222b, 222c may be partially or completely embedded within the balloon wall 224. In the inflated configuration, the tension members 226a, 226b, 226c may be placed under tension and thus elastically stretched between the inner shaft 232 and the reinforcement portions 222a, 22b, 222c, respectively.

[0106] Fig.14 222a, 222b, 222c. In other words, each of the tension members 226a, 226b, 226c can be designed to pull the reinforcement portion 222a, 222b, 222c to which it is attached. Therefore, it should be understood that the tension members 226a, 226b, 226c can direct the balloon 220 to expand in a radially inward direction. Fig.14 The configuration shown refolds, whereby when the tension members 226a, 226b, 226c pull the reinforcement portions 222a, 222b, 222c toward the inner shaft 232 in a substantially uniform configuration (e.g., a configuration in which the reinforcement portions 222a, 222b, 222c are substantially equally spaced around the circumference of the inner shaft 232). It should be appreciated that applying a radially inward force to each of the reinforcement portions 222a, 222b, 222c causes the balloon 220 to refold substantially uniformly and symmetrically. In addition, the uniform, symmetrical refolding of the balloon 220 may result in a reduced folding profile of the scaled balloon 220, which may enable the balloon to be more easily withdrawn into an introducer sheath for inserting the balloon 220 into the body.

[0107] Fig.15Another example balloon catheter 300 is shown. The balloon catheter 300 may include an expandable medical balloon 320 mounted on or attached to a distal end of a catheter shaft, such as an outer catheter shaft 330. The medical balloon 320 may be designed for use in various medical procedures, including valvuloplasty. The catheter shaft 320 may extend from and be attached to a manifold assembly (not shown) positioned at the proximal end of the catheter shaft 330. The balloon 320 may also 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 body portion 312 may be positioned between the proximal tapered portion 314 and the distal tapered portion 316, wherein the proximal waist portion 315 extends proximally of the proximal tapered portion 314, and the distal waist portion 317 extends distally of the distal tapered portion 316. The balloon 320 can be secured to the outer catheter shaft 330 at the proximal waist 315. It should be understood that the catheter shaft of the balloon catheter 300 can also include an inner shaft 332 that can extend within the outer catheter shaft 330, through the interior lumen of the balloon 320 and secured to the distal waist 317 of the balloon 320.

[0108] The inner shaft 332 may include an inner lumen. In at least some embodiments, the inner lumen of the inner shaft 332 may be a guidewire lumen. Therefore, the catheter 300 may be advanced to a desired position over a guidewire. The guidewire lumen may extend substantially along the entire length of the catheter shaft 330, so that the catheter 300 is similar to a traditional "on-the-wire" catheter. Alternatively, the guidewire lumen may extend only along a portion of the shaft 330, so that the catheter 300 is similar to a "single operator exchange" catheter.

[0109] In addition, the outer shaft 330 can also include an inflation lumen, which can be used, for example, to deliver an inflation medium to and from the balloon 320. When the outer shaft 330 is disposed on the inner shaft 332, the inflation lumen can be defined in a space between an outer surface of the inner shaft 332 and an inner surface of the outer shaft 330.

[0110] The balloon 320 may include a balloon wall composed of one or more layers, wherein each of the layers may be composed of different balloon materials. For example, the balloon wall 324 of the balloon 320 may include an inner layer and an outer layer, whereby 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 324 may be coextruded during the manufacturing process of the balloon. Typical balloon materials may include polymeric materials, some examples of which are listed herein.

[0111] In addition, if Fig.15As shown, the balloon 320 may include one or more longitudinally extending reinforcement portions arranged around the circumference of the balloon 320. For example, the balloon 220 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 composed of high-strength fibers (e.g., fiber, fiber, Fibers 322 may be formed of fibers, silk, nylon or other suitable materials. Fibers 322 may extend longitudinally along the body 312 of balloon 320. Fig.15 The fibers 322 are shown extending along the body portion 312 of the balloon 320 , but it is contemplated that the fibers 322 may also be embedded within the proximal tapered portion 314 , the distal tapered portion 316 , or both the proximal tapered portion 314 and the distal tapered portion 316 .

[0112] Fig.16 Shown along Fig.15 16 - 16 is a cross-sectional view of balloon 320 taken along line 16 - 16 , wherein balloon 320 is inflated. Fig.16 Eight longitudinally extending fibers 322 are shown arranged circumferentially about the inner shaft 332 . Fig.16 It is shown that eight fibers 322 may be equally spaced about the inner shaft 332. However, in other examples, the fibers 322 may be unequally spaced about the inner shaft 332. As discussed herein, the balloon 320 may include one, two, three, four, five, six, seven, eight, nine, ten, or more fibers 322 arranged about the inner shaft 332 and extending longitudinally through the body portion 312, and optionally through or into the proximal tapered portion 314 and / or the distal tapered portion 316.

[0113] Fig.16 Also shown are fibers 322 embedded within the balloon wall 324 of the balloon 320. Fig.16 It should be appreciated that circumferential portions of balloon wall 324 extend between each of fibers 322, thereby establishing discrete areas of continuous balloon wall 324 that are free of fibers 322. In some cases, when fully inflated, the circumferential areas of balloon wall 324 that are free of fibers 322 may extend radially outward to a greater extent than the portions of balloon wall 324 that have fibers 322 embedded therein. Fig.16 The fibers 322 are shown fully embedded in the wall 324 of the balloon 320, but it is contemplated that in some examples, the fibers 322 may be partially embedded in the balloon wall 324. It is also contemplated that in some examples, the fibers 322 may be directly attached to the inner surface of the balloon 320. For example, it is contemplated that the fibers 322 may be adhesively attached, laminated, or otherwise attached to the inner surface of the balloon 320.

[0114] Fig.17 The balloon 320 is shown after vacuum is drawn to deflate it. Fig.16 The balloon 320. In addition, Fig.17 Each of the fibers 322 is shown to provide a reinforced region that is relatively stiff compared to portions of the balloon wall 324 that extend between the fibers 322 (e.g., portions of the balloon wall 324 that are devoid of fibers 322). Thus, when a vacuum is drawn on the balloon 320, the portions of the balloon wall 324 that extend between the fibers 322 and, therefore, are devoid of fibers 322 will more easily collapse inwardly toward the inner axis 332 of the balloon 320, thereby initiating the balloon 320 to Fig.17 . It should also be appreciated that the resistance to collapse of the fibers 322 of the balloon 320, as compared to other portions of the balloon 320, may result in a symmetrical refolding of the balloon 320 during zooming. This symmetrical refolding of the balloon 320 may result in a reduced folding profile of the zoomed balloon 320, which may enable the balloon 320 to be more easily withdrawn into an introducer sheath for inserting the balloon 320 into the body.

[0115] Example polymers for making 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), 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. In some embodiments, it may be desirable to use a high modulus or generally harder material in order to reduce balloon elongation. The above list of materials includes some examples of materials with higher modulus. 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.

[0116] 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 outer shaft having a distal region; an inner shaft extending within the outer shaft, the inner shaft having an outer surface, a proximal end, and a distal end; a balloon comprising 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; a first interior partition panel disposed within the balloon, wherein the first interior partition panel is coupled to both the exterior surface of the inner shaft and the interior surface of the balloon; and a second interior partition panel disposed within the balloon, wherein the second interior partition panel is coupled to both the exterior surface of the inner shaft and the interior surface of the balloon; Wherein, the first interior partition panel is circumferentially spaced away from the second interior partition panel.

2. The medical device according to claim 1, wherein: The balloon is configured to transform between an inflated configuration and a collapsed configuration, and wherein the balloon includes a first inflation chamber positioned between the first interior panel and the second interior panel.

3. The medical device according to any one of claims 1 to 2, wherein: The balloon is configured to be inflated to a first pressure, and wherein the balloon wall between the first panel and the second panel has a diameter at the first pressure, and wherein a portion of the balloon wall attached to the first panel has a diameter at the first pressure, and wherein, at the first pressure, the diameter of the balloon wall between the first panel and the second panel is greater than the diameter of the portion of the balloon wall attached to the first panel.

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

5. The medical device according to any one of claims 1 to 4, wherein: The first panel is attached to the inner shaft along a first longitudinal attachment area, and wherein the first panel is substantially perpendicular to a tangent line along the inner shaft passing through a point on the first attachment area.

6. The medical device according to any one of claims 1 to 5, wherein: The first panel is attached to the inner shaft along a first longitudinal attachment area, and wherein the first panel forms an acute angle with respect to a tangent line along the inner shaft passing through a point on the first attachment area.

7. The medical device according to claim 6, wherein: The second panel is attached to the inner shaft along a second longitudinal attachment area, and wherein the second panel forms an acute angle with respect to a tangent line along the inner shaft passing through a point on the second attachment area.

8. The medical device according to any one of claims 1 to 7, wherein: The balloon is configured to transform between an inflated configuration and a collapsed configuration, and wherein a portion of the balloon wall adjacent to a portion of the balloon wall attached to the first and second panels is configured to collapse onto the first and second panels in the collapsed configuration.

9. The medical device according to claim 8, wherein: The second panel is configured to be folded onto the first panel in the collapsed configuration.

10. The medical device according to claim 2, wherein: The balloon also includes a third interior partition panel, wherein the third interior partition panel is attached to the outer surface of the inner shaft and the inner surface of the balloon, wherein the third interior partition panel is circumferentially spaced apart from the second interior partition panel, and wherein the balloon includes a second inflation chamber positioned between the third interior panel and the second interior panel, and wherein the first inflation chamber is configured to be inflated independently of the second inflation chamber.

11. A medical device comprising: an outer shaft having a distal region; an inner shaft extending within the outer shaft, the inner shaft having an outer surface, a proximal end, and a distal end; a balloon comprising 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 positioned between the distal waist and the proximal waist; a first reinforcement region positioned along said body portion; as well as A first tension member is coupled to the first reinforcement region and the inner shaft.

12. The medical device according to claim 11, wherein: The first reinforcement region includes a first plurality of filaments.

13. The medical device according to any one of claims 11 to 12, wherein: The first tension member includes a first end region, a second end region, and a middle region, and wherein the middle region wraps around the outer surface of the inner shaft.

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

15. The medical device according to claim 14, wherein: The first tension member includes fibers.

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