Balloon assembly for a balloon catheter

Abstract

Inflatable balloons (202) and balloon assemblies (200) for balloon catheters are disclosed, the inflatable balloon assemblies having an outer frame (204) covering a balloon. As one example, an inflatable balloon assembly for a balloon catheter includes an inflatable balloon, and a frame arranged around the balloon. The frame is expandable to a predetermined maximum diameter (206) that inhibits further inflation of the balloon but allows an inflation pressure inside the balloon to further increase.

Description

BALLOON ASSEMBLY FOR A BALLOON CATHETERCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Patent Application No.63 / 721,746, filed November 18, 2024, which is incorporated by reference herein in its entirety.FIELD

[0002] The present disclosure relates to inflatable balloons for balloon catheters, such as balloon catheters for balloon valvuloplasty, valve-in-valve transcatheter valve replacement, or transcatheter valve replacement.BACKGROUND

[0003] The human heart can suffer from various valvular diseases. These valvular diseases can result in significant malfunctioning of the heart and ultimately require repair of the native valve or replacement of the native valve with an artificial valve. There are a number of known repair devices (e.g., stents) and artificial valves, as well as a number of known methods of implanting these devices and valves in humans. Percutaneous and minimally-invasive surgical approaches are used in various procedures to deliver prosthetic medical devices to locations inside the body that are not readily accessible by surgery or where access without surgery is desirable. In one specific example, a prosthetic heart valve can be mounted in a crimped state on the distal end portion of a delivery apparatus and advanced through the patient’s vasculature (e.g., through a femoral artery and the aorta) until the prosthetic valve reaches the implantation site in the heart. The prosthetic valve is then expanded to its functional size, for example, by inflating a balloon on which the prosthetic valve is mounted.SUMMARY

[0004] Described herein are inflatable balloons or balloon assemblies for medical (balloon) catheters. In some examples, the inflatable balloons described herein can be used in a delivery apparatus for a prosthetic heart valve, or a balloon catheter for breaking opencalcified valve leaflets or fracturing degraded surgical valves. Described herein are examples of balloons that can be used with such balloon catheters. The disclosed balloons or balloon assemblies comprise an inner inflatable balloon and an outer frame surrounding the inflatable balloon that is configured to radially expand to a predetermined maximum expanded diameter, even as an internal pressure of the inflatable balloon continues to increase. As such, the devices and methods disclosed herein can, among other things, overcome one or more of the deficiencies of typical balloon catheters.

[0005] A balloon assembly for a medical catheter can comprise an inflatable balloon and a frame arranged around the balloon.

[0006] In some examples, the frame covers an entirety of the balloon.

[0007] In some examples, the frame is positioned against an exterior surface of the balloon.

[0008] In some examples, the frame is expandable to a predetermined maximum diameter that inhibits further inflation of the balloon.

[0009] In some examples, the predetermined maximum diameter of the frame is in a range of 20-35 mm.

[0010] In some examples, the frame comprises a plurality of interconnected struts defining open cells in the frame.

[0011] In some examples, the plurality of interconnected struts include adjustable stmts that extend between adjacent cells, each adjustable stmt having a middle portion that undulates or zig-zags such that the adjustable stmt lengthens as the frame expands to its predetermined maximum diameter.

[0012] In some examples, the frame comprises a plurality of interconnected stmts defining open cells in the frame, and the frame (e.g., the stmt and / or open cell portion of the frame) covers an entirety of the balloon.

[0013] In some examples, the frame comprises metal.

[0014] In some examples, the frame comprises Nitinol.

[0015] In some examples, the balloon comprises Nylon, Pebax, PEBA (polyether block amide), and / or a thermoplastic elastomer, and / or a combination thereof.

[0016] In some examples, a balloon assembly for a medical catheter comprises an inflatable balloon and a frame arranged around the balloon, wherein the frame is expandable to a predetermined maximum diameter that inhibits further inflation of the balloon but allows an inflation pressure inside the balloon to further increase.

[0017] In some examples, a balloon assembly comprises one or more of the components recited in Examples 1-16 and 66-76 below.

[0018] A balloon catheter can comprise an inflatable balloon.

[0019] In some examples, the balloon catheter can comprise a frame covering an exterior of the balloon.

[0020] In some examples, the frame can comprise a plurality of interconnected struts that are configured to allow the frame to radially expand to a predetermined maximum diameter.

[0021] In some examples, the frame is configured to stop the balloon from expanding further once the frame has reached the predetermined maximum diameter, even as a pressure inside the balloon increases further.

[0022] In some examples, the balloon catheter can comprise a handle and one or more shafts coupled to the handle.

[0023] In some examples, the balloon is mounted to the shaft.

[0024] In some examples, the balloon catheter can comprise a first shaft extending from a handle of the balloon catheter, where a proximal end portion of the balloon and a proximal end portion of the frame are bonded to a distal end of the first shaft.

[0025] In some examples, the balloon catheter can comprise a second shaft extending through the first shaft with a distal end portion of the second shaft extending distally beyond a distal end of the first shaft.

[0026] In some examples, a distal end portion of the frame and a distal end portion of the balloon are bonded to a polymeric body mounted on a distal end of the second shaft.

[0027] In some examples, the frame comprises a shape-memory material.

[0028] In some examples, the frame comprises metal.

[0029] In some examples, a balloon catheter comprises a balloon assembly for a medical catheter comprises an inflatable balloon and a frame arranged around the balloon, wherein the frame is expandable to a predetermined maximum diameter that inhibits further inflation of the balloon but allows an inflation pressure inside the balloon to further increases. The balloon catheter further comprises a handle and a first shaft extending distally from the handle, where a proximal end portion of the balloon is bonded to a distal end of the first shaft.

[0030] In some examples, a balloon catheter comprises an inflatable balloon, where a frame covers an exterior of the balloon, the frame comprising a plurality of interconnected stmts that are configured to allow the frame to radially expand to a predetermined maximumdiameter. The frame is configured to stop the balloon from expanding further once the frame has reached the predetermined maximum diameter, even as a pressure inside the balloon increases further.

[0031] In some examples, a balloon catheter comprises a shaft extending distally from a handle of the balloon catheter. The balloon catheter comprises a balloon comprising an inflatable body and an end portion mounted to the shaft and a frame arranged around the balloon, where the frame comprises a radially expandable body and an end portion mounted to the shaft. The body of the frame is radially expandable from a radially compressed delivery configuration having a first diameter to an expanded configuration having a second diameter that is a predetermined maximum diameter of the frame that inhibits the balloon from radially expanding beyond the predetermined maximum diameter.

[0032] In some examples, a balloon catheter comprises one or more of the components recited in Examples 17-53 and 77-80 below.

[0033] In some examples, a method comprises, as an inflation pressure inside an inflatable balloon of a balloon catheter increases, radially expanding the balloon and a frame covering an exterior of the balloon from a first diameter to a predetermined second diameter.

[0034] The method further comprises, as the inflation pressure inside the balloon continues to increase, maintaining the frame and the balloon at the second diameter, where the second diameter is a maximum diameter of the frame.

[0035] The method further comprises, as the inflation pressure inside the balloon continues to increase, maintaining the frame and the balloon at the second outer diameter, where the second outer diameter is a predetermined maximum inner diameter of the frame.

[0036] In some examples, a method comprises one or more of the features recited in Examples 54-64 below.

[0037] The techniques, methods, processes, operations, steps, etc. described or suggested herein or in the references incorporated herein, and any methods of using the systems, assemblies, apparatuses, devices, etc. herein, can be performed on a living subject (e.g., human, other animal.) or on a simulation (e.g., a cadaver, cadaver heart, simulator, imaginary person). When performed on a simulation, the body parts, e.g., heart, tissue, valve, etc., can be assumed to be simulated or can optionally be referred to as “simulated” (e.g., simulated heart, simulated tissue, simulated valve) and can optionally comprise computerized and / or physical representations of body parts, tissue, etc. The term “simulation” covers use on acadaver, computer simulator, imaginary person (e.g., if they are just demonstrating in the air on an imaginary heart), etc.

[0038] The innovations of this disclosure can be used in combination or separately. This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the detailed description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. The foregoing and other objects, features, and advantages of the disclosure will become more apparent from the following detailed description, claims, and accompanying figures.BRIEF DESCRIPTION OF THE DRAWINGS

[0039] FIG. 1 is a perspective view of an exemplary balloon catheter.

[0040] FIG. 2 is a perspective view of a balloon assembly for a balloon catheter, the balloon assembly including an inner inflatable balloon and an outer frame covering the balloon.

[0041] FIG. 3A depicts a first strut pattern for a frame of a balloon assembly in a radially compressed state, the strut pattern having a plurality of diamond shaped cells.

[0042] FIGS. 3B and 3C depict the first stmt pattern of FIG. 3A in example radially expanded states.

[0043] FIG. 3D depicts the first strut pattern of FIG. 3 A at its maximum expanded diameter.

[0044] FIG. 4A depicts a second stmt pattern for a frame of a balloon assembly in a radially compressed state, the stmt pattern having a plurality of sunken arrow shaped cells.

[0045] FIG. 4B depicts the second stmt pattern of FIG. 4A in a first radially expanded state.

[0046] FIG. 4C depicts the second stmt pattern of FIG. 4A at its maximum expanded diameter.

[0047] FIG. 5 depicts an exemplary apex between stmts of the second stmt pattern of FIG. 4C.

[0048] FIG. 6A depicts a third stmt pattern for a frame of a balloon assembly in a radially compressed state, the strut pattern having a plurality of sunken arrow shaped cells in an alternating arrangement.

[0049] FIG. 6B depicts the third stmt pattern of FIG. 6A in a first radially expanded state.

[0050] FIG. 6C depicts the third stmt pattern of FIG. 6A at its maximum expanded diameter.

[0051] FIG. 7 depicts exemplary apices between stmts of the third stmt pattern of FIG. 6C.

[0052] FIG. 8A depicts a fourth strut pattern for a frame of a balloon assembly in a radially compressed state, the strut pattern having a plurality of hexagonal shaped cells.

[0053] FIGS. 8B-8D depict the fourth strut pattern of FIG. 8A in example radially expanded states with increasing diameters.

[0054] FIG. 8E depicts the fourth stmt pattern of FIG. 8A at its maximum expanded diameter.

[0055] FIG. 9 depicts an exemplary apex between stmts of the fourth stmt pattern of FIG. 8E.

[0056] FIG. 10A depicts a fifth stmt pattern for a frame of a balloon assembly in a radially compressed state, the stmt pattern having a plurality of hexagonal shaped cells that are connected to one another by axially extending members having an adjustable length.

[0057] FIG. 10B depicts the fifth stmt pattern of FIG. 10A in a first radially expanded state.

[0058] FIG. 10C depicts the fifth stmt pattern of FIG. 10A at its maximum expanded diameter.

[0059] FIG. 11A depicts a sixth stmt pattern for a frame of a balloon assembly in a radially compressed state, the stmt pattern having a plurality of hexagonal shaped cells, each connected to at least one adjacent cell by an axially extending member having an adjustable length.

[0060] FIG. 1 IB depicts the sixth stmt pattern of FIG. 11 A in a first radially expanded state.

[0061] FIG. 11C depicts the sixth strut pattern of FIG. 11 A at its maximum expanded diameter.

[0062] FIG. 12A depicts a seventh stmt pattern for a frame of a balloon assembly in a radially compressed state, the stmt pattern having a plurality of hexagonal shaped cells, each connected to at least one adjacent cell by an axially extending member having an adjustable length provided by a zig-zagged middle portion.

[0063] FIG. 12B depicts the seventh stmt pattern of FIG. 12A in a first radially expanded state.

[0064] FIG. 12C depicts the seventh stmt pattern of FIG. 12A at its maximum expanded diameter.

[0065] FIG. 13A depicts an eighth stmt patern for a frame of a balloon assembly in a radially compressed state, the stmt pattern having a plurality of hexagonal shaped cells connected together by angled members having an adjustable length, a portion of the angled members extending in a different direction than another portion of the angled members.

[0066] FIG. 13B depicts the eighth strut pattern of FIG. 13A in a first radially expanded state.

[0067] FIG. 13C depicts the eighth strut pattern of FIG. 13A at its maximum expanded diameter.

[0068] FIG. 14A depicts a ninth strut pattern for a frame of a balloon assembly in a radially compressed state, the strut pattern having a plurality of hexagonal shaped cells connected by angled members having an adjustable length, all the angled members extending in a same direction.

[0069] FIG. 14B depicts the ninth strut pattern of FIG. 14A in a first radially expanded state.

[0070] FIG. 14C depicts the ninth strut pattern of FIG. 14A at its maximum expanded diameter.DETAILED DESCRIPTIONGeneral Considerations

[0071] For purposes of this description, certain aspects, advantages, and novel features of examples of this disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as being limiting in any way. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the disclosed examples, alone and in any suitable combinations and sub-combinations with one another. The methods, apparatus, and systems are not limited to any specific aspect or feature or combination thereof, nor do the disclosed examples require that any one or more specific advantages be present or problems be solved.

[0072] Although the operations of some of the disclosed examples are described in a particular, sequential order for convenient presentation, it should be understood that this manner of description encompasses rearrangement, unless a particular ordering is required by specific language set forth below. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed methods can be used in conjunction with other methods. Additionally, the description sometimes uses terms like “provide” or “achieve” to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations that correspond to these terms may vary depending on the particular implementation and are readily discernible by one of ordinary skill in the art.

[0073] As used in this application and in the claims, the singular forms “a," “an,” and “the” include the plural forms unless the context clearly dictates otherwise. Additionally, the term “includes” means “comprises.” The terms “comprises” and “comprising” should be interpreted as referring to elements, components, or steps in a non-exclusive manner, indicating that the referenced elements, components, or steps may be present, or utilized, or combined with other elements, components, or steps not expressly referenced. Further, the term “coupled” generally means physically, mechanically, chemically, magnetically, and / or electrically coupled or linked and does not exclude the presence of intermediate elements between the coupled or associated items absent specific contrary language. It is further noted that the claims can be drafted to exclude any optional element. As such, this statement is intended to serve as antecedent basis for use of such exclusive terminology as “solely,” “only” and the like in connection with the recitation of claim elements, or use of a “negative” limitation.

[0074] As used herein, the tern “proximal” refers to a position, direction, or portion of a device that is closer to the user and further away from the implantation site. As used herein, the term “distal” refers to a position, direction, or portion of a device that is further away from the user and closer to the implantation site. Thus, for example, proximal motion of a device is motion of the device away from the implantation site and toward the user (e.g., out of the subject’s body), while distal motion of the device is motion of the device away from the user and toward the implantation site (e.g., into the subject’s body). The terms “longitudinal” and “axial” refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined.

[0075] Reference throughout this specification to “an embodiment” or “an implementation” means that a particular feature, structure, or characteristic described in connection with the implementation is included in at least one implementation. Thus, appearances of the phrases “in an implementation” in various places throughout this specification are not necessarily all referring to the same implementation or a single exclusive implementation. Furthermore, the particular features, structures, or characteristics described herein may be combined in any suitable manner in one or more embodiments or one or more implementations.

[0076] Certain numerical values and ranges may be presented herein with numerical values being preceded by the term “about.” The term “about” is used herein to provide literal support for the exact number that it precedes, as well as a number that is near to orapproximately the number that the tern precedes. In determining whether a number is near to or approximately a specifically recited number, the near or approximating un-recited number may be a number which, in the context in which it is presented, provides the substantial equivalent of the specifically recited number.

[0077] The word “exemplary” is used herein to mean “serving as an example, instance, or illustration.” Any aspect described herein as “exemplary” is not necessarily to be construed as preferred or advantageous over other aspects. Unless specifically stated otherwise, the term “some” refers to one or more.

[0078] It will be understood that the benefits and advantages described herein can relate to one implementation or can relate to several implementations. Aspects described in connection with one implementation are intended to be able to be used with the other implementation. Any explanation in connection with one implementation applies to similar features of the other implementations, and elements of multiple implementations can be combined to form other implementations. The implementations are not limited to those that solve any or all of the stated problems or those that have any or all of the stated benefits and advantages.

[0079] The use of any and all examples, or exemplary language (e.g. “such as”) provided with respect to certain implementations herein is intended merely to better illuminate the catheters, devices, assemblies, systems, and methods disclosed herein and does not pose a limitation on the scope of the disclosure otherwise claimed. No language in the specification should be construed as indicating any non-claimed element essential to the practice of the disclosure.

[0080] As used herein, “e.g.” means “for example,” and “i.e.” means “that is.”Overview of the Disclosed Technology

[0081] As introduced above, inflatable balloons are commonly used in various interventional cardiology procedures to open lumens, break up calcification, open stenotic heart valves, fracture degraded surgical valves to allow larger prosthetic valves to be implanted therein, and to deliver prosthetic valves (or other prosthetic valves) to target implantation sites within a vessel or heart of a subject (e.g., a living subject, a simulation). Some of these applications may utilize a compliant or semi-compliant balloon that gets larger as the pressure inside the balloon increases. However, for some applications, a non-compliant balloon that has a smaller change in diameter (and / or limited maximal diameter) as the pressure inside the balloon increases may be preferred. For example, a balloon catheter including a non-compliant balloon may be used when breaking open calcified valve leaflets or fracturing degraded surgical valves within a subject. Non-compliant balloons can be particularly effective to break open rigid structures using a high force without over-expanding inside a subject’s body. However, non-compliant balloons can be typically made from materials such as PET or Kevlar-reinforced polymers which are difficult to bond to the shaft of the catheter (as compared to materials used in compliant or semi-compliant balloons, such as Pebax, PEBA (polyether block amide), a thermoplastic elastomer, and / or Nylon). As such, manufacturing of catheters including non-compliant balloons can be difficult and / or costly.

[0082] Disclosed herein are expandable frames or reinforcing layers having a predetermined maximum expanded diameter that are configured to be arranged around balloons (e.g., compliant or semi-compliant balloons) for balloon catheters. As a result, the balloon for the balloon catheter effectively becomes non-compliant. For example, when the maximum expanded diameter of the frame around the balloon is reached, the balloon stops expanding even as the internal pressure of the balloon continues to increase. The material of the compliant balloon within the frame can easily bond to the catheter shaft. A material of the frame surrounding the balloon can be selected such that the frame collapses down to a smaller diameter for delivery into (and out of) a subject’s vasculature but expands to the predetermined maximum diameter during inflation of the balloon. As a result, balloon catheters including such balloons (or balloon assemblies) can be more easily manufactured and used in procedures where high outward radial force without overexpansion is desired.

[0083] FIG. 1 depicts an exemplary catheter comprising an inflatable balloon. In some examples, an expandable frame can be arranged around the inflatable balloon, as shown in FIG. 2. FIGS. 3A-14C depict examples of frames configured to be arranged around an inflatable balloon and limit the expanded diameter of the balloon to a predetermined maximum diameter.Examples of the Disclosed Technology

[0084] Described herein are examples of a delivery apparatus (sometimes referred to as a delivery catheter) that can be used to navigate a subject's vasculature to deliver an implantable, expandable medical device (e.g., a prosthetic heart valve), tools, agents, or other therapy to a location within the body of a subject. Examples of procedures in which the delivery catheters are useful include neurological, urological, gynecological, fertility (e.g., in vitro fertilization, artificial insemination), laparoscopic, arthroscopic, transesophageal,transvaginal, transvesical, transrectal, and procedures including access in any body duct or cavity. Particular examples include placing implants, including stents, grafts, embolic coils, and the like; opening lumens, breaking up calcification, opening stenotic heart valves, and fracturing degraded surgical valves to allow larger prosthetic valves to be implanted therein.

[0085] FIG. 1 shows a balloon catheter 100 (which can also be referred to herein as a medical catheter), according to an example, that can be used for various intravascular medical procedures. In some examples, the balloon catheter 100 can be used to implant an expandable prosthetic device, such as an expandable heart valve, within a previously implanted device (such as a surgical valve, previously implanted prosthetic heart valve, or a docking device for a prosthetic heart valve). In some examples, the balloon catheter 100 can be used to break open previously implanted devices (surgical valves or prosthetic valves), break apart calcification in vessels or valves, or open a lumen to a wider diameter.

[0086] The balloon catheter 100 in the illustrated example of FIG. 1 comprises a handle 102, a steerable, outer shaft 104 extending from the handle 102, an intermediate shaft 105 extending from the handle 102 coaxially through the steerable outer shaft 104, an inner shaft 106 extending from the handle 102 coaxially through the intermediate shaft 105 and the steerable, outer shaft 104, an inflatable balloon (e.g., balloon) 108 extending from a distal end of the intermediate shaft 105, and a nosecone 110 arranged at a distal end of the balloon catheter 100. A distal end portion 112 of the balloon catheter 100 includes the balloon 108 and the nosecone 110.

[0087] In some examples, the distal end portion 112 of the balloon catheter 100 includes a balloon shoulder assembly. In such example, a prosthetic medical device, such as a prosthetic heart valve may be mounted on a valve retaining portion of the balloon 108, and / or adjacent the balloon 108. A balloon shoulder assembly can be configured to maintain the prosthetic heart valve or other medical device at a fixed position on the balloon 108 during delivery through the subject’s vasculature. In some examples, the balloon shoulder assembly can include a proximal shoulder 120 and / or a distal shoulder 122.

[0088] The balloon 108 can include a central portion (which can be approximately cylindrical when inflated, as shown in FIG. 1) and two tapered end portions that connect to the balloon catheter 100 (e.g., to one or more shafts and / or a nosecone of the delivery apparatus). A length of the balloon 108 can be defined in an axial direction 124 (which can be parallel to acentral longitudinal axis of the balloon catheter 100 and the balloon 108). Further, a lateral or radial direction 126 can be defined perpendicular to the axial direction 124.

[0089] The handle 102 can include a steering mechanism configured to adjust the curvature of the distal end portion of the delivery apparatus. In the illustrated example, for example, the handle 102 includes an adjustment member, such as the illustrated rotatable knob 134, which in turn can be operatively coupled to the proximal end portion of a pull wire (not shown). In some examples, the pull wire extends distally from the handle 102 through the outer shaft 104 and has a distal end portion affixed to the outer shaft at or near the distal end of the outer shaft 104. Rotating the knob 134 can be effective to increase or decrease the tension in the pull wire, thereby adjusting the curvature of the distal end portion of the delivery apparatus.

[0090] The balloon catheter 100 can be configured to be advanced over a guidewire that can be received within a guidewire lumen defined by an innermost shaft of the balloon catheter 100.

[0091] In some examples, the balloon catheter 100 (or a similar delivery apparatus) can be configured to deploy and implant a prosthetic heart valve. Further details on such a delivery apparatus can be found in International Application No. PCT / US2021 / 047056, which is incorporated by reference herein.

[0092] As introduced above, for some applications, a non-compliant balloon that has a smaller change in diameter and / or a preset maximal diameter that prevents the balloon from expanding too far as the pressure inside the balloon increases may be preferred. For example, a balloon catheter including a non-compliant balloon may be used when breaking open calcified valve leaflets or fracturing degraded surgical valves within a subject. Non-compliant balloons can be particularly effective to break open rigid structures using a high force without over-expanding inside a subject’s body. However, non-compliant balloons may be made from materials such as PET or Kevlar-reinforced polymers which are difficult to reliably bond to one or more shafts of the catheter (as compared to materials used in compliant or semi-compliant balloons, such as Pebax, PEBA (polyether block amide), a thermoplastic elastomer, and / or Nylon). As such, manufacturing of catheters including non-compliant balloons can be difficult and / or costly.

[0093] FIG. 2 depicts an example of a balloon assembly 200 for a balloon catheter that comprises an inflatable balloon 202 and a frame 204 arranged around the balloon 202. Theframe 204 is expandable to a predetermined maximum diameter 206 (which can also be referred to herein as a “predetermined maximum expanded diameter) that inhibits further inflation of the balloon 202 but allows an inflation pressure inside the balloon 202 to further increase.

[0094] In some examples, the balloon assembly 200 can replace the balloon 108 in the balloon catheter of FIG. 1.

[0095] The balloon 202 can be a compliant or semi -compliant balloon. For example, the balloon 202 may be the same or similar to a balloon used to radially expand a prosthetic device in a subject using a balloon catheter.

[0096] In some examples, the balloon 202 is a non-compliant balloon.

[0097] In some examples, the balloon 202 comprises nylon, latex, polyurethane, silicone, polyvinyl chloride, polyethylene terephthalate (PET), a polyamide, a co-polyamide, Pebax, PEBA (polyether block amide), a thermoplastic elastomer, a transparent polyamide (e.g., Grilamid), or combinations thereof.

[0098] The material of the balloon 202, or at least the material of the proximal and distal end portions of the balloon can be configured to easily bond to one or more catheter shafts (for example, the intermediate shaft 105 and the nosecone 110 in FIG. 2)

[0099] The balloon 202 can be configured to radially expand as it fills with an inflation fluid, and thus as an inflation pressure inside the balloon increases. In some examples, the balloon 202 can continue to radially expand as its internal pressure increases, until it bursts or is stopped by radially inward pressure from an external source (such as a wall).

[0100] In the balloon assembly 200, the frame 204 acts as a source that limits and stops radial expansion of the balloon 202, even as the internal pressure of the balloon 202 continues to increase, once the frame 204 reaches its predetermined maximum diameter 206. Thus, the balloon assembly 200 (which can include a compliant or non-compliant balloon 202 and the frame 204) functions as a non-compliant balloon. Balloon catheters that include the balloon assembly 200 can be particularly effective for breaking open calcified valve leaflets or fracturing degraded surgical valves within a subject prior to a valve-in-valve procedure, with less risk of rupturing the native annulus.

[0101] Balloon catheters that include the balloon assembly 200 also can be particularly effective for ensuring uniform expansion of a transcatheter prosthetic heart valve, especially when the prosthetic valve is expanded within a docking device, such as a coil or anannuloplasty ring. Some docking devices, such as an annuloplasty ring, are relatively rigid and can restrict expansion of a prosthetic valve. If a compliant or semi-compliant balloon is used to deploy a prosthetic valve within a ring, the prosthetic valve can expand non-uniformly due to the restriction of the ring against a portion of the prosthetic valve and continued expansion of the balloon at other locations along the length of the prosthetic valve. In contrast, the balloon assembly 200 can be sized to expand a prosthetic valve uniformly (having a constant diameter along its length) when deployed within a ring or other docking device.

[0102] As noted above, in some examples, the balloon 202 can be formed from compliant materials (e.g., polyurethane, silicone, or latex), which typically have lower melting temperatures than semi-compliant polymers (e.g., Pebax, PEBA (polyether block amide), a thermoplastic elastomer, and / or nylon) and non-compliant polymers (e.g., PET, or polyester), and therefore are more easily thermally bondable to a wider range of polymers that can be used for forming other components of the balloon catheter. For example, use of a compliant material for the balloon can permit use of relatively softer (lower durometer) polymers for forming the nose cone 110 and / or the shaft 105 to which the end portions of the balloons are thermally bonded. The use of lower durometer polymers, especially for forming the nose cone 110, can allow the nose cone to be more flexible and atraumatic.

[0103] In some examples, the predetermined maximum diameter 206 is in a range of 20-35 mm, 20-32 mm, or 20-30 mm.

[0104] The frame 204 comprises a radially expandable body 208. For example, the body 208 of the frame 204 is radially expandable from a radially compressed delivery configuration having a first diameter (such as shown in FIG. 3A, as described below) to an expanded configuration having a second diameter that is the predetermined maximum diameter 206 (as shown in FIG. 2). At the predetermined maximum diameter 206, the body 208 of the frame 204 stops radially expanding and inhibits the balloon 202 from expanding beyond the predetermined maximum diameter 206.

[0105] As defined herein, the predetermined maximum expanded diameter and second or delivery configuration diameter of a frame (or strut pattern for a frame) can refer to the largest diameter of the body of the frame at any given expanded or delivery configuration. For example, a balloon and its surrounding frame may taper at its end portions from a central portion of the balloon and body. As such, the diameters discussed herein may be defined bycentral portion(s) and / or the largest diameter portion of the balloon and frame, between the tapered end portions.

[0106] The frame 204 can contact an outer surface of the balloon 202. For example, at least at its predetermined maximum diameter 206, the body 208 of the frame 204 can contact the outer surface of the balloon 202.

[0107] In some examples, the body 208 of the frame 204 contacts an outer surface of the balloon 202 as the balloon 202 fills with inflation fluid and a pressure inside the balloon 202 increases. In this way, radial expansion of the balloon 202 applies radially outward pressure to the body 208 of the frame 204 and causes the body 208 to radially expand (as long as a diameter of the frame 204 is less that the predetermined maximum diameter 206).

[0108] In some examples, as shown in FIG. 2, the frame 204 comprises a plurality of interconnected struts 210 that define open cells 212 in the frame 204.

[0109] In the example of FIG. 2, the cells 212 are diamond shaped.

[0110] A material of the frame 204, as well as the other frames described herein, can be selected such that the frame 204 collapses down to a smaller diameter (e.g., the first diameter) for delivery into (and out of) a subject’s vasculature but expands to the predetermined maximum diameter 206 during inflation of the balloon 202.

[0111] In some examples, the frame 204 comprises one or more metals.

[0112] In some examples, the frame 204 comprises a shape-memory metal, such as Nitinol. Nitinol or another shape memory material may be particularly suited for enabling the frame 204 to collapse (or return) back to a smaller diameter (such as the delivery configuration, or first diameter). Thus, in some examples, the frame 204 (and any frames disclosed herein) can be shape-set in a radially collapsed state and can expand under the force of the balloon as the balloon is filled with an inflation fluid, and then radially collapse back to the radially collapsed state under its own resiliency when the inflation fluid is removed from the balloon. This can help to evacuate inflation fluid from the balloon 202 following expansion and enable the balloon catheter to be navigated through a subject’s vasculature for removal from the subject (following a medical procedure using the balloon catheter).

[0113] In some examples, when the frame 204 comprises a metal, the frame 204 is radiopaque and can be detected with medical imaging. As such, contrast may not need to be included in the inflation fluid for inflating the balloon 202. Although widely used, some subjects are allergic to contrast solution or otherwise suffer adverse effects from the use ofcontrast solution should it escape from the balloon inside the subject’s body. Instead, saline (without contrast) may be used as the inflation fluid, for example, where a frame includes a radiopaque material.

[0114] In some examples, the frame 204 comprises a polymer.

[0115] The frame 204 can comprise a first end portion 214 mounted to a first shaft of a balloon catheter, such as the intermediate shaft 105 of the balloon catheter 100, as shown in FIG. 2.

[0116] The frame 204 can comprise a second end portion 216 mounted to a second shaft or polymeric body of a balloon catheter, such as the nosecone 110 of the balloon catheter 100, as shown in FIG. 2.

[0117] In some examples, the first end portion 214 and / or the second end portion 216 are bonded to the respective first shaft and polymeric body by reflowing a polymer over the first end portion 214 and / or the second end portion, thereby bonding the respective end portion of the frame 204 to the respective end portion of the balloon and the shaft or polymeric body.

[0118] In some examples, the first end portion 214 and / or the second end portion 216 are press-fit or clamped onto the respective first shaft and polymeric body, thereby attaching the respective end portion of the frame 204 to the respective end portion of the balloon and the shaft or polymeric body.

[0119] The stmts 210 of the frame 204 can have any suitable arrangements defining any suitable shaped cells 212, as long as the arrangement of stmts 210 results in the frame 204 having a predetermined maximum expanded diameter. It should be appreciated that a frame 204 can have cells of one or more sizes and shapes, and that all suitable sizes and shapes of cells are contemplated herein.

[0120] FIGS. 3A-14C depict examples of stmt patterns (or arrangements) for a frame of a balloon assembly, such as the frame 204 and balloon assembly of FIG. 2, that limit expansion of the balloon to a predetermined maximum expanded diameter of the frame. Each of the stmt patterns shown in FIGS. 3A-14C can be used in an annular frame that is arranged around an inflatable balloon, such as balloon 202. For example, any of the stmt patterns shown in FIGS. 3A-14C can be used in the frame 204 (for example, in lieu of the stmt configuration of the frame 204 shown in FIG. 2).

[0121] It should be noted that FIGS 3A-14C are schematics depicting stmt patterns for a frame in a balloon assembly (such as frame 204) in a flattened configuration, for the ease ofillustration. However, the depicted strut patterns can be repeated and arranged into an annular configuration to form an annular frame, such as the annular frame 204 in FIG. 2.

[0122] Turning first to FIGS. 3A-3D, a first strut pattern 300 for an annular frame of a balloon assembly (such as the frame 204 of FIG. 2) is shown. FIGS. 3A-3D depict the first strut pattern 300 for the frame in example radially collapsed and expanded states, including a smaller, first diameter 302 in FIG. 3A, which may be a delivery configuration or radially collapsed state when included in a balloon catheter. FIG. 3D depicts the first strut pattern 300 at its maximum expanded diameter 306. A central longitudinal axis 304 (which may be a central longitudinal axis of a frame including the stmt pattern) is shown in FIGS. 3A-3D for reference.

[0123] As introduced above and used herein, the “maximum expanded diameter” or “maximum diameter” is a predetermined diameter of the frame that is determined at least in part by the geometry of the stmt pattern. Once the stmt pattern has reached the end of its expandable range, for example, due to tensile forces between connected stmts reaching a threshold value, the frame is at its maximum expanded diameter and cannot expand further. Thus, at the maximum expanded diameter, the frame can be held in place without further expansion, even as radial pressure from the balloon continues to be applied to inner surfaces of the stmts of the frame.

[0124] In some examples, the struts 210 of the frame 204 of FIG. 2 are arranged in the first stmt pattern 300 and the predetermined maximum diameter 206 can be the same as the maximum expanded diameter 306 shown in FIG. 3D.

[0125] The first stmt pattern 300 comprises stmts 308 arranged in a zig-zag stmt pattern defining diamond shaped open cells 310. The diamond shaped cells 310 allow a frame comprising the stmt pattern to radially compress to the delivery configuration (FIG. 3A) and radially expand toward or to the maximum expanded diameter 306 (FIG. 3D).

[0126] Each cell 310 has a height 312 defined in a circumferential direction (perpendicular to the central longitudinal axis 304 in FIGS. 3A-3D) and a width 314 defined in a direction of the central longitudinal axis 304 (referred to herein as an “axial direction”).

[0127] As used herein, a cell of a stmt pattern (for a balloon assembly frame) has a cell height that is defined in a direction perpendicular to a central longitudinal axis of the stmt pattern. When the stmt pattern is in an annular configuration (in a frame, such as shown in FIG. 2), the cell height is defined in a circumferential direction relative to a centrallongitudinal axis of the balloon and frame, which may also be the central longitudinal axis of the balloon catheter (such as central longitudinal axis 220 shown in FIG. 2). A cell width is defined in an axial direction relative to the central longitudinal axis (for example, in a direction parallel to the central longitudinal axis).

[0128] As shown in FIGS. 3A-3D, the height 312 of each cell 310 is at its maximum value at the maximum expanded diameter 306 of the first strut pattern 300 (and a frame including the first strut pattern 300). Said another way, at the maximum expanded diameter 306, the cells 310 are not able to lengthen any further along their height 312. In this way, the maximum expanded diameter 306 of the first strut pattern 300 is predetermined based (in whole or in part) on the specified geometry of the cells 310.

[0129] As shown in FIGS. 3A-3D, the width 314 of each cell 310 is at its shortest value at the maximum expanded diameter 306 of the first strut pattern 300 (and a frame including the first strut pattern 300).

[0130] Thus, as a frame including the first strut pattern 300 radially expands from the first diameter 302 toward or to the maximum expanded diameter 306, the height 312 of the cells 310 increases and the width 314 of the cells 310 decreases. Once a frame including the first strut pattern 300 reaches the maximum expanded diameter 306, the cells 310 can no longer increase in height 312, thereby stopping radial expansion of the frame (and thus the balloon contained therein), even as a radially outward pressure applied against the inside of the frame (for example, from increasing pressure inside the balloon which the frame surrounds or covers) continues to increase.

[0131] FIGS. 4A-4C show a second stmt pattern 400 for an annular frame of a balloon assembly (such as the frame 204 of FIG. 2). FIGS. 4A-4C depict the second stmt pattern 400 for the frame in example radially expanded states, including a smaller, first diameter 402 in FIG. 4A, which may be a delivery configuration when included in a balloon catheter. FIG.4C depicts the second stmt pattern 400 at its maximum expanded diameter 406. A central longitudinal axis 404 (which may be a central longitudinal axis of a frame including the stmt pattern 400) is shown in FIGS. 4A-4C for reference.

[0132] The second stmt pattern 400 comprises stmts 412, 416 arranged to define open cells 410 having a sunken arrow or chevron shape (when a frame including the second stmt pattern 400 has a diameter that is smaller than the maximum expanded diameter 406, as shown in FIGS. 4A and 4B). For example, each cell 410 can be defined by two angled stmts 412forming a tip 414 of the arrow and two adjustable struts 416 (which can also be referred to herein as angled struts) that are each connected to a respective one of the two angled struts 412 and one another.

[0133] While both the angled stints 412 and adjustable struts 416 can be angled relative a direction perpendicular to the central longitudinal axis 404 (for example, the circumferential direction in an annular configuration of a frame) when a diameter the frame including the second strut pattern 400 is less than the maximum expanded diameter, once the frame reaches the maximum expanded diameter 406, only the adjustable struts 416 are parallel (or substantially parallel - e.g., within 10 degrees of parallel, within 5 degrees of parallel) to the circumferential direction (and perpendicular or substantially perpendicular (e.g., within 10 degrees, within 5 degrees of perpendicular) to the central longitudinal axis 404). At this diameter, the angled struts 412 remain angled relative to a direction perpendicular to the central longitudinal axis 404.

[0134] For example, an angle 424 between the angled struts 412 remains at acute angles at and between the first diameter 402 (FIG. 4A) and the maximum expanded diameter 406 (FIG.4C) of a frame including the second strut pattern 400.

[0135] An angle 418 between the two adjustable stmts 416 increases as a frame including the second stmt pattern 400 expands to the maximum expanded diameter 406. The angle 418 may begin as an acute angle (for example, at the first diameter 402 in FIG. 4A) and increase to an obtuse angle as the frame continues to radially expand. In some examples, at the maximum expanded diameter 406, the angle 418 can be at or near 180 degrees (for example, 170-180, 175-180 degrees).

[0136] The internal balloon pressures for achieving the angle 428 can be based on one or more factors, for example, one or more of the frame thickness (e.g., thickness of the stmts 416), material properties of the frame (material properties of the stmts), a geometry and size of the apices (e.g., apices 426 shown in FIG. 5, if present), a combination thereof, and the like. In some examples, the maximum possible internal balloon pressure may not be large enough to fully straighten the angle 418 to 180 degrees (and thus, as noted above, the angle can be in a range of, for example 170-180 degrees).

[0137] In some implementations, once the angle 418 between the adjustable stmts 416 reaches 180 degrees (or approximately 180 degrees, such as 170-180 degrees), the tensile strength of the adjustable stmts 416 resists further radial expansion of the frame including thesecond strut pattern 400. As such, cells 410 are at their maximal height 420 and cannot expand any further. When the angle 418 is 180 degrees, the cells 410 have a triangular pattern (as shown in FIG. 4C)

[0138] Thus, a frame including the second stmt pattern 400 at its maximum expanded diameter 406 would stop radially expanding and inhibit a balloon arranged therein (for example, balloon 202 of FIG. 2) from further expanding, even as a pressure inside the balloon continues to increase.

[0139] The stmts 412, 416 further define open cells 422 having a kite diamond shape when the angle 418 between adjustable stmts 416 is less than 180 degrees and having a triangular shape when the angle 418 is 180 degrees (or substantially triangular shape when the angle 418 is about 180 degrees - e.g., between 170-180 degrees, between 175-180 degrees).

[0140] In some examples, such as the example shown in Figs. 4A-4D, groups of four adjustable stmts 416 define open cells 428 having a diamond shape when the angle 418 between the adjustable stmts 416 is less than 180 degrees. As the angle 418 approaches 180 degrees, the adjustable stmts 416 become closer to vertical (as shown in the views depicted in FIGS. 4A-4C, or perpendicular to the central longitudinal axis 404), thereby making the cells 428 smaller. Once the angle 418 reaches 180 degrees (as shown in FIG. 4C), each group of four adjustable stmts 416 become aligned or generally aligned with one another (for example, coincident in the circumferential direction) and the open cell 428 may no longer be present and / or may have a very short height.

[0141] In some examples, a circumferentially extending row of open cells 428 is disposed around a middle portion of a frame including the second stmt pattern 400.

[0142] In some examples, each pair of adjustable stmts 416 forming the angle 418 can be connected by an apex 426 (or apex region), as shown in the detail view of FIG. 5. Each apex 426 can be formed at a junction between straight portions of a pair of adjustable stmts 416. As shown in FIG. 5, in some examples, the apex 426 has a curved shape, even at the predetermined maximum expanded diameter 406 (FIG. 4C). The apex 426 forms a curve that extends away from one strut 416 in a first direction (e.g., a distal direction) and then back to the other stmt 416 in a different and / or opposite direction (e.g., a proximal direction). The apex 426 is configured to reduce the strain on the adjustable stmts 416 as the frame including the second stmt pattern 400 expands, and to resist further expansion at the maximum expanded diameter 406.

[0143] FIGS. 6A-6C show a third strut pattern 450 for an annular frame of a balloon assembly (such as the frame 204 of FIG. 2). FIGS. 6A-6C depict the third strut pattern 450 for the frame in example radially expanded states, including a smaller, first diameter 452 in FIG. 6A, which may be a delivery configuration when included in a balloon catheter. FIG.6C depicts the third stmt pattern 450 at its maximum expanded diameter 456. A central longitudinal axis 454 (which may be a central longitudinal axis of a frame including the stmt pattern 450) is shown in FIGS. 6A-6C for reference.

[0144] The third stmt pattern 450 is the same as the second stmt pattern 400 (as described above), except it includes an additional pair of adjustable stmts 416 and alternating sunken arrow or chevron shaped open cells 410 oriented in opposite directions. This creates additional diamond shaped cells 428 between adjacent arrow shaped cells 410 when the angle 418 between adjustable stmts 416 is less than 180 degrees.

[0145] At the maximum expanded diameter 456, the two pairs of adjustable stmts 416 defining each cell 428 can be coincident (or close to coincident) with one another. This produces two sets of straight connectors or stmts 416 at the maximum expanded diameter 456 (as opposed to only one set as in the second stmt pattern 400), thereby providing more radial strength to the frame including the third stmt pattern 450.

[0146] In some examples, each pair of adjustable stmts 416 forming the angle 418 can be connected by the apex 426 (or apex region), as shown in the detail view of FIG. 7. This can be the same as in the second stmt pattern 400, except at the maximum expanded diameter 456, there are two adjacent apices 426 between adjacent cells 410, one extending distally and the other extending proximally. As noted above, the apices 426 are configured to reduce the strain on the adjustable stmts 416, and thus the frame including the third stmt pattern 450, at the maximum expanded diameter 456.

[0147] FIGS. 8A-8E show a fourth stmt pattern 500 for an annular frame of a balloon assembly (such as the frame 204 of FIG. 2). FIGS. 8A-8E depict the fourth stmt pattern 500 for the frame in example radially expanded states, including a smaller, first diameter 502 in FIG. 8A, which may be a delivery configuration when included in a balloon catheter. FIG.8E depicts the fourth stmt pattern 500 at its maximum expanded diameter 506. A central longitudinal axis 504 (which may be a central longitudinal axis of a frame including the stmt pattern 500) is shown in FIGS. 8A-8E for reference.

[0148] The fourth stmt pattern 500 comprises stmts 512, 514 arranged to define open cells 510 having a hexagonal shape (thereby creating a honeycomb-like stmcture). Each cell 510 can be defined by one pair of opposing stmts 514 that are parallel to the central longitudinal axis 504 and two pairs of directly connected stmts 512 that are non-parallel to the central longitudinal axis.

[0149] Each cell 510 has a height 522 defined in a circumferential direction (perpendicular to the central longitudinal axis 504 in FIGS. 8A-8E) and a width 524 defined in a direction of the central longitudinal axis 504 (referred to herein as an “axial direction”). As the frame including the fourth stmt pattern 500 increases from the first diameter 502 toward or to the maximum expanded diameter 506, the width 524 of each cell decreases and the height 522 of each cell increases.

[0150] A first angle 518 is defined between pairs of directly connected stmts 512, where both stmts of the pair of directly connected stmts 512 are non-parallel to the central longitudinal axis 504. The first angles 518 of each cell 510 approach 180 degrees (e.g., between 170-180, between 175-180 degrees) as the frame including the fourth stmt pattern 500 expands to the maximum expanded diameter 506 (as shown in FIG. 8E).

[0151] In some examples, including the example shown in FIGS. 8A-8E, the first angles 518 can start as acute angles (as shown in FIGS. 8 A and 8B) and increase to obtuse angles as the frame continues to radially expand (as shown in FIGS. 8C and 8D).

[0152] In some examples, the first angles 518 may not reach 180 degrees. For example, at the maximum expanded diameter 506 (FIG. 8E), the first angles 518 can be between 170 and 180 degrees at the maximum expanded diameter 506.

[0153] The internal balloon pressures for achieving the first angle 518 can be based on one or more factors, including for example, one or more of the frame thickness (thickness of the stmts 512), material properties of the frame (material properties of the stmts), a geometry and size of the apices (e.g., apices 526 shown in FIG. 9, if present), a combination thereof, and the like. In some examples, the maximum possible internal balloon pressure may not be large enough to fully straighten the angle 518 to 180 degrees (and thus, as noted above, the angle can be in a range of 170-180 degrees, 175-180 degrees). In some examples, the angles 518 reach 180 degrees (and the stmts 512 of each pair are coincident) at the maximum expanded diameter such that each cell 510 is rectangular at the maximum expanded diameter.

[0154] As used herein, a “rectangular" shape can include a regular rectangular shape and / or a generally rectangular shape with one or more curved, angled, protruding, concave, etc. portions (e.g., apices). Similarly, as used herein, a “diamond” shape can include a regular diamond shape and / or a generally diamond shape with one or more curved, angled, protruding, concave, etc. portions (e.g., apices). Similarly, as used herein, a “hexagon” shape can include a regular hexagon shape and / or a generally hexagon shape with one or more curved, angled, protruding, concave, etc. portions (e.g., apices). The same principle applies to any cell shapes described herein, including, for example, sunken arrow shape, triangle shape, octagonal shape, etc.

[0155] At the maximum expanded diameter 506, the tensile strength of the stmts 512 resists further radial expansion of the frame including the fourth stmt pattern 500. As such, cells 510 are at their maximal height 522 and cannot expand any further.

[0156] Thus, a frame including the fourth stmt pattern 500 at its maximum expanded diameter 506 would stop radially expanding and inhibit a balloon arranged therein (for example, balloon 202 of FIG. 2) from further expanding, even as a pressure inside the balloon continues to increase.

[0157] In some examples, an apex 526 (or apex region) is formed at a junction between stmts 512, 514 that define adjacent cells 510. For example, as shown in FIG. 9, each apex 526 can be formed between a pair of connected struts 512 and one strut 514 that extends away from the peak of the apex 526. In this way, the apex 526 can connect straight portions of the pair of connected stmts 512.

[0158] As shown in FIG. 9, in some examples, the apex 526 has a curved shape, even at the predetermined maximum expanded diameter 506 (FIG. 8E). The apex 526 is configured to reduce the strain on the stmts 512, 514, and thus the frame including the fourth stmt pattern 500, during radial expansion of the frame and at the maximum expanded diameter 506.

[0159] FIGS. 10 A- 10C show a fifth stmt pattern 600 for an annular frame of a balloon assembly (such as the frame 204 of FIG. 2). FIGS. 10A-10C depict the fifth stmt pattern 600 for the frame in example radially expanded states, including a smaller, first diameter 602 in FIG. 10A, which may be a delivery configuration when included in a balloon catheter. FIG.10C depicts the fifth stmt pattern 600 at its maximum expanded diameter 606. A central longitudinal axis 604 (which may be a central longitudinal axis of a frame including the stmt pattern 600) is shown i

[0160] The fifth strut pattern 600 comprises struts 612, 614 arranged to define open cells 610 having a hexagonal shape (thereby creating a honeycomb structure). Each cell 610 can be defined by one pair of opposing struts 614 that are parallel to the central longitudinal axis 604 and two pairs of directly connected stmts 612 that are non-parallel to the central longitudinal axis.

[0161] Each cell 610 has a height 622 defined in a circumferential direction (perpendicular to the central longitudinal axis 604 in FIGS. 10 A- 10C) and a width 624 defined in a direction of the central longitudinal axis 604 (referred to herein as an “axial direction”). As the frame including the fifth stmt pattern 600 increases from the first diameter 602 toward or to the maximum expanded diameter 606, the width 624 of each cell 610 decreases and the height 622 of each cell 610 increases.

[0162] A first angle 618 is defined between pairs of directly connected stmts 612, where both stmts of the pair of directly connected stmts 612 are non-parallel to the central longitudinal axis 604. The first angles 618 of each cell 610 approach 180 degrees (e.g., 170-180, 175-180) as the frame including the fifth stmt pattern 600 expands to the maximum expanded diameter 606 (as shown in FIG. 10C).

[0163] In some examples, including the example shown in FIGS. 10A-10C, the first angles 618 can start as acute angles (as shown in FIG. 10 A) and increase to obtuse angles as the frame continues to radially expand (as shown in FIGS. 10B and 10C).

[0164] In some examples, the first angles 618 may not reach 180 degrees. For example, at the maximum expanded diameter 606 (FIG. 10C), the first angles 618 can be between 170 and 180 degrees at the maximum expanded diameter 606. In some examples, the first angles 618 reach 180 degrees at the maximum expanded diameter.

[0165] At the maximum expanded diameter 606, the tensile strength of the struts 612 resists further radial expansion of the frame including the fifth strut pattern 600. As such, cells 610 are at their maximal height 622 and cannot expand any further.

[0166] Thus, a frame including the fifth stmt pattern 600 at its maximum expanded diameter 606 would stop radially expanding and inhibit a balloon arranged therein (for example, balloon 202 of FIG. 2) from further expanding, even as pressure inside the balloon continues to increase.

[0167] To prevent foreshortening of the frame including the fifth stmt pattern 600 during radial expansion of the frame, the fifth stmt pattern 600 can further include axially extendingstruts 608 (for example, extending in a direction of the central longitudinal axis 604) that extend between adjacent cells 610. For example, each axially extending strut 608 can extend between strut junctions 616 (e.g., between a strut junction 616 between a strut 612 and strut 614 or two struts 612 of a first cell 610 and another stmt junction 616 between a stmt 612 and stmt 614 or two stmts 612 of an adjacent, second cell 610).

[0168] In some examples, e.g., as shown in FIGS. 10A-10C, each axially extending stmt 608 has a middle portion 620 that undulates (with a curved, serpentine, or a sine-wave like pattern, as shown in FIGS. 10A-10C and 11 A-l 1C) or zig-zags (with sharp transitions between straight stmt portions, as shown in FIGS. 12A-12C) such that the axially extending stmt 608 lengthens (in the axial direction) as the frame expands to its predetermined maximum expanded diameter 606. As a result, an overall length 628 of the frame including axially extending stmts 608 (e.g., the fifth stmt pattern 600) can remain constant throughout radial expansion of the frame (for example, from the first diameter 602 to the maximum expanded diameter 606). In some examples, the stmts 608 are sized to permit the frame to increase in length as it radially expands.

[0169] FIGS. 11 A-l 1C show a sixth stmt pattern 630 for an annular frame of a balloon assembly (such as the frame 204 of FIG. 2). FIGS . 11 A- 11 C depict the sixth stmt pattern 630 for the frame in example radially expanded states, including a smaller, first diameter 632 in FIG. 11 A, which may be a delivery configuration when included in a balloon catheter. FIG.11C depicts the sixth stmt pattern 630 at its maximum expanded diameter 636. A central longitudinal axis 634 (which may be a central longitudinal axis of a frame including the stmt pattern 630) is shown in FIGS. 11A-11C for reference.

[0170] The sixth stmt pattern 630 is the same as the fifth stmt pattern 600 (as described above), except there are fewer axially extending stmts 608 in the sixth stmt pattern 630. For example, only a portion of junctions 616 of one cell 610 are connected to an adjacent cell 610, while another portion of junctions 616 of the cell 610 are not connected to an adjacent cell 610.

[0171] FIGS. 12A-12C show a seventh stmt pattern 640 for an annular frame of a balloon assembly (such as the frame 204 of FIG. 2). FIGS. 12A-12C depict the seventh stmt pattern 640 for the frame in example radially expanded states, including a smaller, first diameter 642 in FIG. 12 A, which may be a delivery configuration when included in a balloon catheter. FIG. 12C depicts the seventh stmt pattern 640 at its maximum expanded diameter 646. Acentral longitudinal axis 644 (which may be a central longitudinal axis of a frame including the strut pattern 640) is shown in FIGS. 12A-12C for reference.

[0172] The seventh strut pattern 640 is the same as the sixth strut pattern 630 (as described above), except the middle portion 620 of the axially extending struts 608 has a zig-zag or sawtooth shape instead of undulating with curved transitions. For example, the middle portion 620 of the axially extending struts 608 is formed by oscillating straight strut portions that are connected to one another by acute angles to switch direction of the oscillation.

[0173] FIGS. 13A-13C show an eighth stmt pattern 650 for an annular frame of a balloon assembly (such as the frame 204 of FIG. 2). FIGS. 13A-13C depict the eighth stmt pattern 650 for the frame in example radially expanded states, including a smaller, first diameter 652 in FIG. 13 A, which may be a delivery configuration when included in a balloon catheter. FIG. 13C depicts the eighth strut pattern 650 at its maximum expanded diameter 656. A central longitudinal axis 654 (which may be a central longitudinal axis of a frame including the strut pattern 650) is shown in FIGS. 13A-13C for reference.

[0174] The eighth strut pattern 650 is the same as the sixth strut pattern 630 (as described above), except instead of the axially extending struts 608, the eighth strut pattern 650 includes angled struts 658 extending between adjacent cells 610 at a non-zero angle relative to an axial direction and circumferential direction which are relative to the central longitudinal axis 654. Said another way, the angled struts 658 can extend between a strut junction 616 of a first cell 610 and a strut junction 616 of an adjacent, second cell 610 at a non-zero and non-perpendicular angle relative to the central longitudinal axis 654.

[0175] In some examples, as shown in FIGS. 13A-13C, the angled struts 658 can extend in alternating directions. For example, a first circumferentially extending row of angled struts 658 can extend in a first direction and an adjacent, second circumferentially extending row of angled struts 658 can extend in a second direction, wherein the second direction is 180 degrees rotated from the first direction.

[0176] Each angled strut 658 can have a middle portion 662 that undulates or zig-zags such that the angled strut 658 lengthens as the frame expands to its maximum expanded diameter 656 (as shown in FIG. 13C), allowing the frame to maintain a constant overall length or increase in length as the frame radially expands. For example, as shown in FIGS. 13A-13C, the middle portions 662 comprise stmt portions that undulate or oscillate with curved transitions, similar to a sine wave.

[0177] FIGS. 14A-14C show a ninth strut pattern 670 for an annular frame of a balloon assembly (such as the frame 204 of FIG. 2). The ninth strut pattern 670 is the same as the eighth strut pattern (as described above), except the angled struts 658 are all extending in the same direction between the adjacent cells 610.

[0178] It should be noted that the axially extending struts 608, angled stmts 658, or both the axially extending stmts 608 and angled stmts 658 can be used in stmt patterns for a balloon assembly frame (such as frame 204 of FIG. 2) that have differently shaped cells than those shown in FIGS. 8A-14C, such as diamond shaped, sunken arow shaped, octagonal shaped, or the like. Further, in some examples, stmt patterns for balloon assembly frames (such as frame 204 of FIG. 2) can comprise two or more differently shaped cells within the same frame, such as hexagonal and diamond shape or triangular and sunken arrow shaped. In this way, one or more different features of the example stmt patterns described herein with reference to FIGS. 3A-14C can be combined together within a single frame for a ballon assembly. For example, one feature of one stmt pattern can be combined with another feature of another stmt pattern in the same frame for a balloon assembly.Delivery Techniques

[0179] For implanting a prosthetic valve within the native aortic valve via a transfemoral delivery approach, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral artery and are advanced into and through the descending aorta, around the aortic arch, and through the ascending aorta. The prosthetic valve is positioned within the native aortic valve and radially expanded (e.g., by inflating a balloon, actuating one or more actuators of the delivery apparatus, or deploying the prosthetic valve from a sheath to allow the prosthetic valve to self-expand). Additionally and / or alternatively, a prosthetic valve can be implanted within the native aortic valve in a transapical procedure, whereby the prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart and the prosthetic valve is positioned within the native aorticvalve. Additionally and / or alternatively, in a transaortic procedure, a prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the aorta through a surgical incision in the ascending aorta, such as through a partial J-sternotomy or right parasternalmini-thoracotomy, and then advanced through the ascending aorta toward the native aortic valve.

[0180] For implanting a prosthetic valve within the native mitral valve via a transseptal delivery approach, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral vein and are advanced into and through the inferior vena cava, into the right atrium, across the atrial septum (through a puncture made in the atrial septum), into the left atrium, and toward the native mitral valve. Additionally and / or alternatively, a prosthetic valve can be implanted within the native mitral valve in a transapical procedure, whereby the prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart and the prosthetic valve is positioned within the native mitral valve.

[0181] For implanting a prosthetic valve within the native tricuspid valve, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral vein and are advanced into and through the inferior vena cava, and into the right atrium, and the prosthetic valve is positioned within the native tricuspid valve. A similar approach can be used for implanting the prosthetic valve within the native pulmonary valve or the pulmonary artery, except that the prosthetic valve is advanced through the native tricuspid valve into the right ventricle and toward the pulmonary valve / pulmonary artery.

[0182] Another delivery approach is a transatrial approach whereby a prosthetic valve (on the distal end portion of the delivery apparatus) is inserted through an incision in the chest and an incision made through an atrial wall (of the right or left atrium) for accessing any of the native heart valves. Atrial delivery can also be made intravascularly, such as from a pulmonary vein. Still another delivery approach is a transventricular approach whereby a prosthetic valve (on the distal end portion of the delivery apparatus) is inserted through an incision in the chest and an incision made through the wall of the right ventricle (typically at or near the base of the heart) for implanting the prosthetic valve within the native tricuspid valve, the native pulmonary valve, or the pulmonary artery.

[0183] In all delivery approaches, the delivery apparatus can be advanced over a guidewire previously inserted into a subject’s vasculature. Moreover, the disclosed delivery approachesare not intended to be limited. Any of the prosthetic valves disclosed herein can be implanted using any of delivery procedures and delivery devices known in the art.

[0184] Any of the systems, devices, apparatuses, etc. herein can be sterilized (for example, with heat / thermal, pressure, steam, radiation, and / or chemicals, etc.) to ensure they are safe for use with subjects, and any of the methods herein can include sterilization of the associated system, device, apparatus, etc. as one of the steps of the method. Examples of heat / thermal sterilization include steam sterilization and autoclaving. Examples of radiation usable and / or for use in sterilization include, without limitation, gamma radiation, ultra-violet radiation, and electron beam. Examples of chemicals usable and / or for use in sterilization include, without limitation, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. Sterilization with hydrogen peroxide may be accomplished using hydrogen peroxide plasma, for example.Additional Examples of the Disclosed Technology

[0185] In view of the above-described implementations of the disclosed subject matter, this application discloses the additional examples enumerated below. It should be noted that one feature of an example in isolation or more than one feature of the example taken in combination and, optionally, in combination with one or more features of one or more further examples are further examples also falling within the disclosure of this application.

[0186] Example 1. A balloon assembly for a medical catheter, comprising: an inflatable balloon; and a frame arranged around the balloon, wherein the frame is expandable to a predetermined maximum diameter that inhibits further inflation of the balloon but allows an inflation pressure inside the balloon to further increase.

[0187] Example 2. The balloon assembly of any example herein, particularly example 1, wherein the frame contacts an outer surface of the balloon.

[0188] Example 3. The balloon assembly of any example herein, particularly example 1 or 2, wherein the frame comprises a plurality of interconnected struts that define open cells in the frame.

[0189] Example 4. The balloon assembly of any example herein, particularly example 3, wherein the plurality of interconnected struts is arranged in a zig-zag strut pattern defining diamond shaped open cells, and wherein, at the predetermined maximum diameter, a height of each cell of the frame is at its maximum value, the height defined in a circumferential direction relative to a central longitudinal axis of the balloon assembly.

[0190] Example 5. The balloon assembly of any example herein, particularly example 3, wherein the plurality of interconnected struts is arranged in a pattern such that the open cells have a sunken arrow shape, wherein each cell is defined by two angled struts forming a tip of the aiTow and two adjustable stmts that are each connected to a respective one of the two angled stmts and the other adjustable stmt of the two adjustable stmts, wherein an angle between the two adjustable stmts increases as the frame expands to the predetermined maximum diameter, and wherein at the predetermined maximum diameter of the frame, the angle between the two adjustable stmts is in a range of 170-180 degrees.

[0191] Example 6. The balloon assembly of any example herein, particularly example 5, wherein an apex is formed at a junction between straight portions of the two adjustable stmts, and wherein the apex has a curved shape, even at the predetermined maximum diameter of the frame.

[0192] Example 7. The balloon assembly of any example herein, particularly example 3, wherein the plurality of interconnected stmts is arranged in a pattern such that the open cells have a hexagonal shape, wherein each cell is defined by two pairs of directly connected stmts that are non-parallel to a central longitudinal axis of the balloon assembly, and wherein angles between the pairs of directly connected stmts approach 180 degrees as the frame expands to the predetermined maximum diameter.

[0193] Example 8. The balloon assembly of any example herein, particularly example 7, wherein the plurality of interconnected stmts further comprises axially extending stmts extending between adjacent hexagonal shaped cells, and wherein each axially extending stmt has a middle portion that undulates or zig-zags such that the axially extending stmt lengthens as the frame expands to its predetermined maximum diameter.

[0194] Example 9. The balloon assembly of any example herein, particularly example 7, wherein the plurality of interconnected stmts further comprises angled stmts extending between adjacent hexagonal shaped cells at a non-zero and non -perpendicular angle relative to a central longitudinal axis of the balloon assembly, and wherein each angled stmt has a middle portion that undulates or zig-zags such that the angled strut lengthens as the frame expands to its predetermined maximum diameter.

[0195] Example 10. The balloon assembly of any example herein, particularly example 7, wherein an apex is formed at a junction between stmts of the plurality of interconnectedstruts that define adjacent hexagonal shaped cells, and wherein the apex has a curved shape, even at the predetermined maximum diameter of the frame.

[0196] Example 11. The balloon assembly of any example herein, particularly any one of examples 1-10, wherein the frame comprises metal.

[0197] Example 12. The balloon assembly of any example herein, particularly example 11, wherein the metal is Nitinol.

[0198] Example 13. The balloon assembly of any example herein, particularly any one of examples 1-10, wherein the frame comprises a polymer.

[0199] Example 14. The balloon assembly of any example herein, particularly any one of examples 1-13, wherein the balloon comprises Nylon.

[0200] Example 15. The balloon assembly of any example herein, particularly any one of examples 1-13, wherein the balloon comprises Pebax, PEBA (polyether block amide), and / or a thermoplastic elastomer.

[0201] Example 16. The balloon assembly of any example herein, particularly any one of examples 1-15, wherein the predetermined maximum diameter of the frame is in a range of 20-35 mm.

[0202] Example 17. A balloon catheter comprising: the balloon assembly of any example herein, particularly any one of examples 1-16; a handle; and a first shaft extending distally from the handle, wherein a proximal end portion of the balloon is bonded to a distal end of the first shaft.

[0203] Example 18. The balloon catheter of any example herein, particularly example 17, further comprising a second shaft extending through the first shaft with a distal end portion of the second shaft extending distally beyond the distal end of the first shaft, and wherein a distal end portion of the balloon is bonded to the distal end portion of the second shaft.

[0204] Example 19. The balloon catheter of any example herein, particularly example 18, wherein a distal end portion of the frame is coupled to the distal end portion of the second shaft.

[0205] Example 20. The balloon catheter of any example herein, particularly any one of examples 17-19, wherein a proximal end portion of the frame is coupled to the distal end of the first shaft.

[0206] Example 21. A balloon catheter, comprising: an inflatable balloon, wherein a frame covers an exterior of the balloon, the frame comprising a plurality of interconnected stmtsthat are configured to allow the frame to radially expand to a predetermined maximum diameter, and wherein the frame is configured to stop the balloon from expanding further once the frame has reached the predetermined maximum diameter, even as a pressure inside the balloon increases further.

[0207] Example 22. The balloon catheter of any example herein, particularly example 21, wherein the plurality of interconnected struts defines open cells in the frame, wherein each cell has a cell height that is defined in a circumferential direction relative to a central longitudinal axis of the balloon and a cell width that is defined in an axial direction relative to the central longitudinal axis.

[0208] Example 23. The balloon catheter of any example herein, particularly example 22, wherein the frame is expandable from a radially compressed delivery configuration to the predetermined maximum diameter, and wherein the cell height of each cell is larger the predetermined maximum diameter than in the delivery configuration.

[0209] Example 24. The balloon catheter of any example herein, particularly example 23, wherein the cell width is smaller at the predetermined maximum diameter of the frame than in the delivery configuration.

[0210] Example 25. The balloon catheter of any example herein, particularly example 24, wherein the plurality of interconnected struts include adjustable stmts that extend between adjacent cells, wherein each adjustable stmt has a middle portion that undulates or zig-zags such that the adjustable stmt lengthens as the frame expands to its predetermined maximum diameter and enables the frame to maintain a constant length between the delivery configuration and the predetermined maximum diameter, the length defined in a direction of the central longitudinal axis, between proximal and distal ends of the frame.

[0211] Example 26. The balloon catheter of any example herein, particularly any one of examples 21-25, wherein the frame comprises a proximal end portion, a distal end portion, and an intermediate portion disposed between the proximal end portion and distal end portion, wherein the intermediate portion comprises the plurality of interconnected stmts that are expandable to the predetermined maximum diameter, and wherein the proximal and distal ends portions of the frame surround respective proximal and distal end portions of the balloon.

[0212] Example 27. The balloon catheter of any example herein, particularly example 26, further comprising a first shaft extending from a handle of the balloon catheter, wherein theproximal end portion of the balloon and the proximal end portion of the frame are bonded to a distal end of the first shaft.

[0213] Example 28. The balloon catheter of any example herein, particularly example 27, further comprising a second shaft extending through the first shaft with a distal end portion of the second shaft extending distally beyond a distal end of the first shaft, and wherein the distal end portion of the frame and the distal end portion of the balloon are bonded to a polymeric body mounted on a distal end of the second shaft.

[0214] Example 29. The balloon catheter of any example herein, particularly any one of examples 21-28, wherein the frame comprises metal.

[0215] Example 30. The balloon catheter of any example herein, particularly example 29, wherein the metal is a shape memory material that allows the frame to return to a radially compressed delivery configuration upon deflation of the balloon.

[0216] Example 31. The balloon catheter of any example herein, particularly any one of examples 21-28 wherein the frame comprises a polymer.

[0217] Example 32. The balloon catheter of any example herein, particularly any one of example 21-31, wherein the balloon comprises Nylon.

[0218] Example 33. The balloon catheter of any example herein, particularly any one of examples 21-31, wherein the balloon comprises Pebax, PEBA (poly ether block amide), and / or a thermoplastic elastomer.

[0219] Example 34. The balloon catheter of any example herein, particularly any one of examples 21-33, wherein the predetermined maximum diameter of the frame is in a range of 20-30 mm.

[0220] Example 35. The balloon catheter of any example herein, particularly any one of examples 21-34, wherein the plurality of interconnected stmts define diamond shaped open cells, and wherein, at the predetermined maximum diameter, a height of each cell is at its maximum value which prevents the frame from further radial expansion, the height defined in a circumferential direction relative to a central longitudinal axis of the balloon assembly.

[0221] Example 36. The balloon catheter of any example herein, particularly any one of examples 21-34, wherein the plurality of interconnected stmts defines open cells having a sunken arrow shape, wherein each cell is defined by a first two angled stmts forming a rip of the aiTow shaped cell and a second two angled stmts that are each connected to a respective one of the two angled stmts and angle toward to the tip to connect to the other angled stmt ofthe second two angled struts, wherein an angle between the second two angled struts increases as the frame expands to the predetermined maximum diameter, and wherein at the predetermined maximum diameter of the frame, the angle between the two adjustable struts is in a range of 170-180 degrees.

[0222] Example 37. The balloon catheter of any example herein, particularly example 36, wherein an apex is formed at a junction between the second two angled struts, and wherein the apex has a curved shape at the predetermined maximum diameter of the frame that reduces strain on the second two angled stmts.

[0223] Example 38. The balloon catheter of any example herein, particularly any one of examples 21-34, wherein the plurality of interconnected stmts defines open cells having a hexagonal shape, wherein each cell is defined by two pairs of directly connected stmts that are non-parallel to a central longitudinal axis of the balloon assembly, and wherein an angle between each pair of directly connected stmts approaches 180 degrees as the frame expands to the predetermined maximum diameter.

[0224] Example 39. The balloon catheter of any example herein, particularly example 38, wherein the plurality of interconnected stmts further comprises axially extending stmts extending between adjacent hexagonal shaped cells, and wherein each axially extending stmt has a middle portion that undulates or zig-zags such that the axially extending stmt lengthens as the frame expands to the predetermined maximum diameter.

[0225] Example 40. The balloon catheter of any example herein, particularly example 38, wherein the plurality of interconnected stmts further comprises angled stmts extending between adjacent hexagonal shaped cells at a non- zero and non-perpendicular angle relative to a central longitudinal axis of the balloon assembly, and wherein each angled stmt has a middle portion that undulates or zig-zags such that the angled stmt lengthens as the frame expands to the predetermined maximum diameter.

[0226] Example 41. The balloon catheter of any example herein, particularly any one of examples 38-40, wherein an apex is formed at a junction between stmts of the plurality of interconnected struts that define adjacent hexagonal shaped cells, and wherein the apex has a curved shape, even at the predetermined maximum diameter of the frame.

[0227] Example 42. A balloon catheter comprising: a shaft extending distally from a handle of the balloon catheter; a balloon comprising an inflatable body and an end portion mounted to the shaft; and a frame arranged around the balloon, wherein the frame comprises a radiallyexpandable body and an end portion mounted to the shaft, wherein the body of the frame is radially expandable from a radially compressed delivery configuration having a first diameter to an expanded configuration having a second diameter that is a predetermined maximum diameter of the frame that inhibits the balloon from radially expanding beyond the predetermined maximum diameter.

[0228] Example 43. The balloon catheter of any example herein, particularly example 42, wherein when a diameter of the frame is between the first diameter and the predetermined maximum diameter, the balloon and frame are configured to expand together, and after reaching the predetermined maximum diameter, the frame and balloon stop expanding even as pressure inside the balloon continues to increase.

[0229] Example 44. The balloon catheter of any example herein, particularly example 42 or 43, wherein the predetermined maximum diameter is in a range of 20-32 mm.

[0230] Example 45. The balloon catheter of any example herein, particularly any one of examples 42-44, wherein the end portion of the frame is a proximal end portion of the frame and the end portion of the balloon is a proximal end portion of the balloon, further comprising a second shaft extending through the first shaft with a distal end portion of the second shaft extending distally beyond a distal end of the first shaft, and wherein the distal end portion of the frame and the distal end portion of the balloon are mounted to a polymeric body mounted on a distal end of the second shaft.

[0231] Example 46. The balloon catheter of any example herein, particularly any one of examples 42-45, wherein the body of the frame comprises a plurality of interconnected struts that define open cells in the frame, wherein each cell has a cell height that is defined in a circumferential direction relative to a central longitudinal axis of the balloon and a cell width that is defined in an axial direction relative to the central longitudinal axis.

[0232] Example 47. The balloon catheter of any example herein, particularly example 46, wherein as the frame radially expands from the first diameter to the second diameter, the cell height of each cell increases, and the cell width of each cell decreases.

[0233] Example 48. The balloon catheter of any example herein, particularly example 46 or 47, wherein the plurality of interconnected struts includes adjustable struts that extend between adjacent cells, wherein each adjustable strut has a middle portion that undulates or zig-zags such that the adjustable stmt lengthens as the frame expands to the predeterminedmaximum diameter and enables the frame to maintain a constant length between the first diameter and the second diameter.

[0234] Example 49. The balloon catheter of any example herein, particularly any one of examples 42-48, wherein the frame comprises metal.

[0235] Example 50. The balloon catheter of any example herein, particularly example 49, wherein the metal is a shape memory metal that is configured such that the frame returns to the first diameter upon deflation of the balloon.

[0236] Example 51. The balloon catheter of any example herein, particularly any one of examples 42-48, wherein the frame comprises a polymer.

[0237] Example 52. The balloon catheter of any example herein, particularly any one of examples 42-51, wherein the balloon comprises Nylon.

[0238] Example 53. The balloon catheter of any example herein, particularly any one of examples 42-51, wherein the balloon comprises Pebax, PEBA (poly ether block amide), a thermoplastic elastomer.

[0239] Example 54. A method comprising: as an inflation pressure inside an inflatable balloon of a balloon catheter increases, radially expanding the balloon and a frame covering an exterior of the balloon from a first diameter to a predetermined second diameter; and as the inflation pressure inside the balloon continues to increase, maintaining the frame and the balloon at the second diameter, wherein the second diameter is a maximum diameter of the frame.

[0240] Example 55. The method of any example herein, particularly example 54, wherein radially expanding the balloon and the frame includes inflating the balloon with an inflation fluid.

[0241] Example 56. The method of any example herein, particularly example 55, wherein the inflation fluid is saline.

[0242] Example 57. The method of any example herein, particularly any one of examples 54-56, further comprising, deflating the balloon such that the balloon and the frame compress toward or to the first diameter.

[0243] Example 58. The method of any example herein, particularly any one of examples 54-57, wherein the first diameter is a delivery configuration for the balloon and frame and the second diameter is a deployed configuration for the balloon and frame.

[0244] Example 59. The method of any example herein, particularly any one of examples 54-58, wherein the frame comprises metal.

[0245] Example 60. The method of any example herein, particularly any one of examples 54-59, wherein the frame comprises Nitinol.

[0246] Example 61. The method of any example herein, particularly any one of examples 54-60, wherein the frame comprises a plurality of interconnected struts defining open cells in the frame.

[0247] Example 62. The method of any example herein, particularly example 61, wherein the radially expanding the balloon and the frame from the first diameter to the predetermined second diameter includes increasing a height of the open cells until struts defining the height of the open cells experience a tensile strength that resists further extension of the struts and radial expansion of the frame.

[0248] Example 63. The method of any example herein, particularly example 61 or 62, wherein the plurality of interconnected struts include adjustable stmts that extend between adjacent cells, wherein each adjustable stmt has a middle portion that undulates or zig-zags that enables the adjustable stmt to lengthen as the frame radially expands from the first diameter to the predetermined second diameter, thereby maintaining a constant length of the frame at and between the first diameter and the predetermined second diameter.

[0249] Example 64. A method comprising sterilizing the prosthetic heart valve, apparatus, and / or assembly of any example.

[0250] Example 65. A prosthetic heart valve of any one of examples 1-63, wherein the prosthetic heart valve is sterilized.

[0251] Example 66. A balloon assembly for a medical catheter, comprising: an inflatable balloon; and a frame arranged around the balloon, wherein the frame is expandable to a predetermined maximum diameter, wherein when the frame is expanded to the predetermined maximum diameter, the frame inhibits further inflation of the balloon but allows an inflation pressure inside the balloon to further increase.

[0252] Example 67. The balloon assembly of example 66, wherein the frame contacts an outer surface of the balloon.

[0253] Example 68. The balloon assembly of example 66 or 67, wherein the frame is arranged around the entire balloon.

[0254] Example 69. The balloon assembly of any of examples 66-68, wherein the frame comprises a plurality of interconnected struts that define open cells in the frame.

[0255] Example 70. The balloon assembly of example 69, wherein the plurality of interconnected struts comprises a first pair of struts that are non-parallel to a central longitudinal axis of the balloon assembly, and wherein an angle between the first pair of struts increases as the frame expands to the predetermined maximum diameter.

[0256] Example 71. The balloon assembly of example 70, wherein an apex is formed between the first pair of stmts.

[0257] Example 72. The balloon assembly of example 70 or 71, wherein the plurality of interconnected stmts further comprises a second pair of stmts that are non-parallel to the central longitudinal axis of the balloon assembly, and wherein an angle between the second pair of stmts increases as the frame expands to the predetermined maximum diameter.

[0258] Example 73. The balloon assembly of example 72, wherein an apex is formed between the second pair of stmts.

[0259] Example 74. The balloon assembly of any of examples 69-73, wherein the plurality of interconnected stmts further comprises a set of connecting stmts extending between adjacent cells, and wherein each connecting stmt of the set of connecting stmts has a portion that undulates or zig-zags such that the connecting stmt lengthens as the frame expands to its predetermined maximum diameter.

[0260] Example 75. The balloon assembly of example 74, wherein the set of connecting stmts comprises angled stmts extending between adjacent cells at a non-zero and nonperpendicular angle relative to a central longitudinal axis of the balloon assembly.

[0261] Example 76. The balloon assembly of any of examples 71-75, wherein each of the apex formed between the first set of stmts and the apex formed between the second set of stmts has a curved shape, even at the predetermined maximum diameter of the frame.

[0262] Example 77. A balloon catheter comprising: the balloon assembly of any one of examples 66-76; a handle; and a first shaft extending distally from the handle, wherein a proximal end portion of the balloon is bonded to a distal end of the first shaft.

[0263] Example 78. A balloon catheter of example 77, wherein the plurality of interconnected stmts defines open cells in the frame, wherein each cell has a cell height that is defined in a circumferential direction relative to a central longitudinal axis of the balloon and a cell width that is defined in an axial direction relative to the central longitudinal axis.

[0264] Example 79. A balloon catheter of example 78, wherein the frame is expandable from a radially compressed delivery configuration to the predetermined maximum diameter, and wherein the cell height of each cell is larger at the predetermined maximum diameter than in the delivery configuration.

[0265] Example 80. A balloon catheter of example 79, wherein the cell width is smaller at the predetermined maximum diameter of the frame than in the delivery configuration.

[0266] Thus, specific examples of balloon catheters, devices, assemblies, and related methods have been disclosed. The above description of the disclosed implementations is provided to enable any person skilled in the art to make or use the balloon catheters, devices, assemblies, and methods disclosed herein. The preceding detailed description illustrates examples and is not intended to limit the disclosure or the application and uses of the balloon catheters, devices, assemblies, and methods disclosed herein. Various modifications to these implementations will be readily apparent to those skilled in the art, and the general principles described herein can be applied to other implementations without departing from the spirit or scope of the disclosure. Thus, it is to be understood that the description and drawings presented herein represent an implementation of the catheters, devices, assemblies, and methods and are therefore representative of the subject matter which is broadly contemplated by the present application. It is further understood that the scope of the present application fully encompasses other implementations that may become obvious to those skilled in the art and that the scope of the present application is accordingly not limited.

[0267] Groupings of alternative elements or implementations of the disclosure herein are not to be construed as limitations. Each group member can be referred to and claimed individually or in any combination with other members of the group or other elements found herein. One or more members of a group can be included in, or deleted from, a group for reasons of convenience and / or patentability. When any such inclusion or deletion occurs, the specification is herein deemed to contain the group as modified thus fulfilling the written description of all groups used in the appended claims.

[0268] The features described herein with regard to any example can be combined with other features described in any one or more of the other examples, unless otherwise stated. For example, any one or more of the features of one balloon assembly can be combined with any one or more features of another balloon assembly. As another example, any one or morefeatures of one strut pattern for a frame of a balloon assembly can be combined with any one or more features of another strut pattern for a frame of a balloon assembly.

[0269] In view of the many possible ways in which the principles of the disclosure may be applied, it should be recognized that the illustrated configurations depict examples of the disclosed technology and should not be taken as limiting the scope of the disclosure nor the claims. Rather, the scope of the claimed subject matter is defined by the following claims and their equivalents.

[0270] All structural and functional equivalents to the components of the various aspects described throughout this disclosure that are known or later come to be known to those of ordinary skill in the art are expressly incorporated herein by reference and are intended to be encompassed by the claims. Moreover, nothing disclosed herein is intended to be dedicated to the public regardless of whether such disclosure is explicitly recited in the claims.

Claims

WE CLAIM:

1. A balloon assembly for a medical catheter, comprising:an inflatable balloon; anda frame arranged around the balloon, wherein the frame is expandable to a predetermined maximum diameter that inhibits further inflation of the balloon but allows an inflation pressure inside the balloon to further increase.

2. The balloon assembly of claim 1, wherein the frame contacts an outer surface of the balloon.

3. The balloon assembly of either claim 1 or claim 2, wherein the frame comprises a plurality of interconnected struts that define open cells in the frame.

4. The balloon assembly of claim 3, wherein the plurality of interconnected struts is arranged in a pattern such that the open cells have a hexagonal shape, wherein each cell is defined by two pairs of directly connected struts that are non-parallel to a central longitudinal axis of the balloon assembly, and wherein angles between the pairs of directly connected struts approach 180 degrees as the frame expands to the predetermined maximum diameter.

5. The balloon assembly of claim 4, wherein the plurality of interconnected struts further comprises axially extending stmts extending between adjacent hexagonal shaped cells, and wherein each axially extending stmt has a middle portion that undulates or zig-zags such that the axially extending stmt lengthens as the frame expands to its predetermined maximum diameter.

6. The balloon assembly of claim 4, wherein the plurality of interconnected stmts further comprises angled stmts extending between adjacent hexagonal shaped cells at a nonzero and non-perpendicular angle relative to a central longitudinal axis of the balloon assembly, and wherein each angled stmt has a middle portion that undulates or zig-zags such that the angled stmt lengthens as the frame expands to its predetermined maximum diameter.

7. The balloon assembly of claim 4, wherein an apex is formed at a junction between stmts of the plurality of interconnected struts that define adjacent hexagonal shaped cells, and wherein the apex has a curved shape, even at the predetermined maximum diameter of the frame.

8. A balloon catheter comprising:the balloon assembly of any one of claims 1-7;a handle; anda first shaft extending distally from the handle, wherein a proximal end portion of the balloon is bonded to a distal end of the first shaft.

9. The balloon catheter of claim 8, wherein a proximal end portion of the frame is coupled to the distal end of the first shaft.

10. A balloon catheter, comprising:an inflatable balloon, wherein a frame covers an exterior of the balloon, the frame comprising a plurality of interconnected struts that are configured to allow the frame to radially expand to a predetermined maximum diameter, and wherein the frame is configured to stop the balloon from expanding further once the frame has reached the predetermined maximum diameter, even as a pressure inside the balloon increases further.

11. The balloon catheter of claim 10, wherein the plurality of interconnected struts defines open cells in the frame, wherein each cell has a cell height that is defined in a circumferential direction relative to a central longitudinal axis of the balloon and a cell width that is defined in an axial direction relative to the central longitudinal axis.

12. The balloon catheter of claim 11, wherein the frame is expandable from a radially compressed delivery configuration to the predetermined maximum diameter, and wherein the cell height of each cell is larger at the predetermined maximum diameter than in the delivery configuration.

13. The balloon catheter of claim 12, wherein the cell width is smaller at the predetermined maximum diameter of the frame than in the delivery configuration.

14. The balloon catheter of claim 13, wherein the plurality of interconnected stmts include adjustable stmts that extend between adjacent cells, wherein each adjustable stmt has a middle portion that undulates or zig-zags such that the adjustable stmt lengthens as the frame expands to its predetermined maximum diameter and enables the frame to maintain a constant length between the delivery configuration and the predetermined maximum diameter, the length defined in a direction of the central longitudinal axis, between proximal and distal ends of the frame.

15. The balloon catheter of any one of claims 10-14, wherein the frame comprises a proximal end portion, a distal end portion, and an intermediate portion disposed between the proximal end portion and distal end portion, wherein the intermediate portion comprises the plurality of interconnected stmts that are expandable to the predetermined maximumdiameter, and wherein the proximal and distal ends portions of the frame surround respective proximal and distal end portions of the balloon.

16. The balloon catheter of claim 15, further comprising a first shaft extending from a handle of the balloon catheter, wherein the proximal end portion of the balloon and the proximal end portion of the frame are bonded to a distal end of the first shaft.

17. The balloon catheter of claim 16, further comprising a second shaft extending through the first shaft with a distal end portion of the second shaft extending distally beyond a distal end of the first shaft, and wherein the distal end portion of the frame and the distal end portion of the balloon are bonded to a polymeric body mounted on a distal end of the second shaft.

18. A method comprising :as an inflation pressure inside an inflatable balloon of a balloon catheter increases, radially expanding the balloon and a frame covering an exterior of the balloon from a first diameter to a predetermined second diameter; andas the inflation pressure inside the balloon continues to increase, maintaining the frame and the balloon at the second diameter, wherein the second diameter is a maximum diameter of the frame.

19. The method of claim 18, further comprising, deflating the balloon such that the balloon and the frame compress toward or to the first diameter.

20. The method of either claim 18 or claim 19, wherein the first diameter is a delivery configuration for the balloon and frame and the second diameter is a deployed configuration for the balloon and frame.

21. A balloon assembly for a medical catheter, comprising:an inflatable balloon; anda frame arranged around the balloon, wherein the frame is expandable to a predetermined maximum diameter, wherein when the frame is expanded to the predetermined maximum diameter, the frame inhibits further inflation of the balloon but allows an inflation pressure inside the balloon to further increase.

22. The balloon assembly of claim 21, wherein the frame contacts an outer surface of the balloon.

23. The balloon assembly of claim 21 or 22, wherein the frame is arranged around the entire balloon.

24. The balloon assembly of any of claims 21-23, wherein the frame comprises a plurality of interconnected struts that define open cells in the frame.

25. The balloon assembly of claim 24, wherein the plurality of interconnected struts comprises a first pair of stmts that are non-parallel to a central longitudinal axis of the balloon assembly, and wherein an angle between the first pair of stmts increases as the frame expands to the predetermined maximum diameter.

26. The balloon assembly of claim 25, wherein an apex is formed between the first pair of stmts.

27. The balloon assembly of claim 25 or 26, wherein the plurality of interconnected stmts further comprises a second pair of stmts that are non-parallel to the central longitudinal axis of the balloon assembly, and wherein an angle between the second pair of stmts increases as the frame expands to the predetermined maximum diameter.

28. The balloon assembly of claim 27, wherein an apex is formed between the second pair of stmts.

29. The balloon assembly of any of claims 24-28, wherein the plurality of interconnected stmts further comprises a set of connecting stmts extending between adjacent cells, and wherein each connecting stmt of the set of connecting stmts has a portion that undulates or zig-zags such that the connecting stmt lengthens as the frame expands to its predetermined maximum diameter.

30. The balloon assembly of claim 29, wherein the set of connecting stmts comprises angled stmts extending between adjacent cells at a non-zero and non-perpendicular angle relative to a central longitudinal axis of the balloon assembly.

31. The balloon assembly of any of claims 26-30, wherein each of the apex formed between the first set of stmts and the apex formed between the second set of stmts has a curved shape, even at the predetermined maximum diameter of the frame.

32. A balloon catheter comprising:the balloon assembly of any one of claims 21-31;a handle; anda first shaft extending distally from the handle, wherein a proximal end portion of the balloon is bonded to a distal end of the first shaft.

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