Catheter for balloon valvuloplasty in IVUS

Abstract

The balloon valvuloplasty catheter may include an elongate shaft (110) having a guidewire lumen (112) and a device lumen (114) extending longitudinally therethrough, an expandable balloon (120) secured to a distal portion of the elongate shaft, and an intravascular ultrasound catheter (130) slidably disposed within the device lumen. The device lumen is in fluid communication with the interior of the expandable balloon. A method of preparing a native aortic heart valve of a patient's heart for transcatheter aortic valve replacement may include assessing the position of the native valve leaflets relative to the left and right coronary ostia using balloon valvuloplasty and observing by intravascular ultrasound to determine whether the native valve leaflets will occlude the left and / or right coronary ostia when the expandable balloon is inflated.

Description

[Technical field]

[0001] FIELD OF THE DISCLOSURE The present disclosure relates to medical devices and methods of making and / or using medical devices. More particularly, the present disclosure relates to balloon valvuloplasty catheters for use in heart valves. [Background technology]

[0002] A wide variety of intracorporeal medical devices have been developed for medical applications, such as intravascular use. Some of these devices include guidewires, catheters, medical device delivery systems (e.g., stents, grafts, replacement valves, etc.), and the like. These devices can be manufactured by any one of a variety of different manufacturing methods and used according to any one of a variety of methods. Each of the known medical devices and methods has certain advantages and disadvantages. There is a continuing need to provide alternative medical devices and alternative methods of manufacturing and using medical devices. Summary of the Invention

[0003] In a first example, a balloon valvuloplasty catheter may include an elongate shaft having a guidewire lumen and a device lumen extending longitudinally therethrough, an expandable balloon secured to a distal portion of the elongate shaft, and an intravascular ultrasound catheter slidably disposed within the device lumen. The device lumen may be in fluid communication with the interior of the expandable balloon.

[0004] In addition or as an alternative to any of the examples disclosed herein, the intravascular ultrasound catheter is configured to image tissue surrounding the expandable balloon when the expandable balloon is in an expanded configuration.

[0005] In addition or as an alternative to any of the examples disclosed herein, the elongate shaft includes an inflation lumen in fluid communication with the interior of the expandable balloon. In addition or in the alternative to any of the examples disclosed herein, the device lumen defines at least a portion of an inflation lumen.

[0006] In addition or as an alternative to any of the examples disclosed herein, the device lumen includes a proximal seal configured to engage an outer surface of the intravascular ultrasound catheter. In addition to or as an alternative to any of the examples disclosed herein, the intravascular ultrasound catheter includes an ultrasound transducer disposed proximate a distal end of the intravascular ultrasound catheter.

[0007] In addition or as an alternative to any of the examples disclosed herein, the ultrasound transducer is configured to move longitudinally within the expandable balloon. In addition or as an alternative to any of the examples disclosed herein, the device lumen terminates within the interior of the expandable balloon.

[0008] In addition or as an alternative to any of the examples disclosed herein, a first radiopaque marker is disposed adjacent a proximal end of the expandable balloon and a second radiopaque marker is disposed adjacent a distal end of the expandable balloon.

[0009] In addition or as an alternative to any of the examples disclosed herein, there is provided a method of preparing a native aortic heart valve of a patient's heart for transcatheter aortic valve replacement, comprising the steps of: percutaneously advancing a guidewire through the native aortic heart valve and into a left ventricle of the patient's heart; A catheter for balloon valvuloplasty, comprising: an elongate shaft having a guidewire lumen and a device lumen extending longitudinally therethrough; an expandable balloon secured to a distal portion of the elongate shaft; an intravascular ultrasound catheter slidably disposed within the device lumen; wherein the device lumen is in fluid communication with an interior of the expandable balloon. advancing a balloon valvuloplasty catheter over the guidewire to a location adjacent the native aortic heart valve; placing an expandable balloon within the native aortic heart valve; imaging the left coronary ostium, the right coronary ostium, and the native leaflets of the native aortic heart valve using an intravascular ultrasound catheter; Inflating an expandable balloon within the native aortic heart valve; Observing the position of the native valve leaflets relative to the left and right coronary artery ostia by intravascular ultrasound; The method may include:

[0010] In addition to or in the alternative to any of the examples disclosed herein, the method may include adjusting a position of the intravascular ultrasound catheter within the expandable balloon by axially sliding the intravascular ultrasound catheter relative to the elongate shaft.

[0011] In addition to or in the alternative to any of the examples disclosed herein, the method may include evaluating a position of the native valve leaflets relative to the left and right coronary ostia to determine whether the native valve leaflets block the left and / or right coronary ostia when the expandable balloon is inflated.

[0012] In addition to or in the alternative to any of the examples disclosed herein, the method may include imaging the native aortic heart valve using an intravascular ultrasound catheter to measure the size of the native aortic heart valve.

[0013] In addition to or as an alternative to any of the examples disclosed herein, imaging the native aortic heart valve using an intravascular ultrasound catheter is performed while an expandable balloon is inflated within the native aortic heart valve.

[0014] In addition to or as an alternative to any of the examples disclosed herein, imaging the native aortic heart valve using an intravascular ultrasound catheter is performed while the expandable balloon is fully inflated within the native aortic heart valve.

[0015] In addition or as an alternative to any of the examples disclosed herein, there is provided a method of repairing a native aortic heart valve in a patient's heart, comprising the steps of: percutaneously advancing a guidewire through the native aortic heart valve and into a left ventricle of the patient's heart; A catheter for balloon valvuloplasty, comprising: an elongate shaft having a guidewire lumen and a device lumen extending longitudinally therethrough; an expandable balloon secured to a distal portion of the elongate shaft; an intravascular ultrasound catheter slidably disposed within the device lumen; wherein the device lumen is in fluid communication with an interior of the expandable balloon. advancing a balloon valvuloplasty catheter over the guidewire to a location adjacent the native aortic heart valve; placing an expandable balloon within the native aortic heart valve; imaging the left coronary ostium, the right coronary ostium, and the native leaflets of the native aortic heart valve using an intravascular ultrasound catheter; Inflating an expandable balloon within the native aortic heart valve; Observing the position of the native valve leaflets relative to the left and right coronary artery ostia by intravascular ultrasound; evaluating the position of the native valve leaflets relative to the left and right coronary ostia to determine whether the native valve leaflets occlude the left and / or right coronary ostia when the expandable balloon is inflated; removing the balloon valvuloplasty catheter while maintaining the guidewire in place within the left ventricle of the patient's heart; advancing a delivery device over the guidewire to the native aortic heart valve; thereafter, placing a replacement aortic heart valve implant within the native aortic heart valve using the delivery device such that neither the left nor right coronary ostia are blocked by the native valve leaflets when the replacement aortic heart valve implant is placed; The method may include:

[0016] In addition or as an alternative to any of the examples disclosed herein, if one or both of the left and right coronary ostia are blocked by the native valve leaflets when the expandable balloon is inflated, placement of the replacement aortic heart valve implant is abandoned.

[0017] In addition to or as an alternative to any of the examples disclosed herein, the method may include imaging the native aortic heart valve using an intravascular ultrasound catheter while the expandable balloon is fully inflated to measure the size of the native aortic heart valve.

[0018] In addition to or in the alternative to any of the examples disclosed herein, the method may include selecting a replacement aortic heart valve implant based on a size of the native aortic heart valve measured by imaging the native aortic heart valve using an intravascular ultrasound catheter.

[0019] In addition to or in the alternative to any of the examples disclosed herein, the method may include loading the selected replacement aortic heart valve implant into a delivery device. The above summary of some embodiments, aspects, and / or examples is not intended to describe each disclosed embodiment or every implementation of the present disclosure. The following figures and detailed description more particularly exemplify these embodiments.

[0020] The present disclosure may be more fully understood from consideration of the following detailed description in conjunction with the accompanying drawings, in which: [Brief description of the drawings]

[0021] [Figure 1] 1 is a schematic diagram illustrating an exemplary configuration of a heart. [Diagram 2] FIG. 2 illustrates an exemplary replacement aortic valve implant positioned in the heart of FIG. 1. [Diagram 3] FIG. 2 is a schematic diagram of another exemplary configuration of the heart. [Figure 4]FIG. 4 illustrates an exemplary replacement aortic valve implant positioned in the heart of FIG. 3. [Diagram 5] FIG. 1 shows an embodiment of a balloon valvuloplasty catheter. [Figure 6] FIG. 1 illustrates an embodiment of the use of a balloon valvuloplasty catheter in the heart. [Figure 7] FIG. 1 illustrates an embodiment of the use of a balloon valvuloplasty catheter in the heart. [Figure 8] 1 is a block diagram illustrating a portion of a method for preparing a native aortic heart valve of a heart for transcatheter aortic valve replacement and / or a method for repairing a native aortic heart valve. [Figure 9] 1A-1D illustrate aspects of a method for repairing a native aortic heart valve. [Figure 10] 1A-1D illustrate aspects of a method for repairing a native aortic heart valve. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0022] While aspects of the present disclosure are amenable to various modifications and alternative forms, details thereof have been shown by way of example in the drawings and will be described in detail. It is to be understood, however, that the intention is not to limit aspects of the present disclosure to the particular embodiments described. On the contrary, the present invention is intended to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure.

[0023] The following description should be read with reference to the drawings, which are not necessarily to scale, but in which like reference numerals refer to like elements throughout the several views. The detailed description and drawings are intended to illustrate, rather than limit, the present disclosure. Those skilled in the art will recognize that the various elements described and / or illustrated can be arranged in various combinations and configurations without departing from the scope of the present disclosure. The detailed description and drawings show exemplary embodiments of the present disclosure. However, for clarity and ease of understanding, not all features and / or elements may be shown in each drawing, although it can be understood that the features and / or elements are present unless otherwise specified.

[0024] For the following defined terms, these definitions shall be applied, unless a different definition is given in the claims or elsewhere in this specification. In this specification, all numerical values ​​are assumed to be modified by the term "about", whether or not expressly indicated. The term "about" in the context of numerical values ​​generally refers to a range of numbers that a person of ordinary skill in the art would consider equivalent to the recited value (e.g., having the same function or result). In many cases, the term "about" can include numbers that are rounded to the nearest significant figure. Other uses of the term "about" (e.g., in non-numerical contexts) can be assumed to have their normal, customary definition as understood from and consistent with the context of this specification, unless otherwise specified.

[0025] The recitation of numerical ranges by endpoints includes all numbers within that range, including the endpoints (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5). Although some suitable dimensions, ranges and / or values ​​for various components, features and / or specifications are disclosed, one of ordinary skill in the art inspired by this disclosure will understand that the desired dimensions, ranges and / or values ​​may deviate from those expressly disclosed.

[0026] As used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally used in the sense of including "and / or," unless the content clearly dictates otherwise. For ease of understanding, it should be noted that some features of the present disclosure may be described in the singular even though those features may be multiple or repeated within the disclosed embodiments. Each instance of a feature may include and / or be encompassed by the singular disclosure unless expressly stated to the contrary. For simplicity and clarity, not all elements of the present disclosure are necessarily shown in each figure or described in detail below. However, it will be understood that the following description may equally apply to any and / or all of the components present in more than one instance, unless expressly stated to the contrary. Moreover, for clarity, not all instances of some elements or features are shown in each figure.

[0027] Relative terms such as "proximal," "distal," "advance," "retract," and variations thereof may generally be considered with respect to the position, orientation, and / or movement of various elements relative to a user / operator / manipulator of the device, with "proximal" and "retract" indicating or referring to being closer to or toward the user, and "distal" and "advance" indicating or referring to being further from or away from the user. In some cases, the terms "proximal" and "distal" may be arbitrarily assigned to facilitate understanding of the present disclosure, and such cases will be readily apparent to those of ordinary skill in the art. Other relative terms such as "upstream," "downstream," "inflow," and "outflow" refer to the direction of fluid flow within a body lumen, lumen such as a blood vessel, or within a device. Still other relative terms such as "axial," "circumferential," "longitudinal," "lateral," "radial," and / or variations thereof generally refer to directions and / or orientations relative to a central longitudinal axis of the disclosed structure or device.

[0028] The term "range" may be understood to mean the maximum measurement of a stated or specified dimension, unless the range or dimension is prefaced with or specified as "minimum," which may be understood to mean the minimum measurement of the stated or specified dimension. For example, an "outer range" may be understood to mean an outer dimension, a "radial range" may be understood to mean a radial dimension, and a "longitudinal range" may be understood to mean a longitudinal dimension. Each instance of "range" may be different (e.g., axially, longitudinally, laterally, radially, circumferentially, etc.) and will be clear to one of ordinary skill in the art from the context of the particular use. In general, a "range" may be considered the maximum possible dimension measured according to the intended application, while a "minimum range" may be considered the minimum possible dimension measured according to the intended application. In some cases, a "range" may generally be measured orthogonally in a plane and / or cross section, but may also be measured differently, such as, but not limited to, angularly, radially, circumferentially (e.g., along an arc), as will be clear from the particular context.

[0029] The terms "monolithic" and "unitary" shall generally refer to one or more elements made up of or consisting of a single structure or base unit / element. Monolithic and / or unitary element shall exclude structures and / or features made up by assembling or otherwise joining together multiple separate structures or elements.

[0030] The terms "transaortic valve implantation" and "transcatheter aortic valve implantation" may be used interchangeably and each may be referred to using the acronym "TAVI." The terms "transaortic valve replacement" and "transcatheter aortic valve replacement" may be used interchangeably and each may be referred to using the acronym "TAVR."

[0031] It should be noted that references herein to "one embodiment," "some embodiments," "other embodiments," and the like, indicate that the described embodiment may include a particular feature, structure, or characteristic, but that not all embodiments necessarily include the particular feature, structure, or characteristic. Moreover, such phrases do not necessarily refer to the same embodiment. Moreover, when a particular feature, structure, or characteristic is described in relation to an embodiment, it will be within the knowledge of one of ordinary skill in the art to affect the particular feature, structure, or characteristic in relation to other embodiments, unless expressly stated to the contrary, whether or not explicitly described. That is, it is contemplated that various individual elements described below, even if not explicitly shown in a particular combination, can be combined or arranged with one another to form other additional embodiments or to complement and / or enhance the described embodiments, as will be understood by one of ordinary skill in the art.

[0032] For purposes of clarity, certain distinguishing numerical nomenclature (e.g., first, second, third, fourth, etc.) may be used throughout the specification and / or claims to name and / or distinguish various features of the specification and / or claims. It should be understood that the numerical nomenclature is not intended to be limiting, but is merely exemplary. In some embodiments, modifications and departures from previously used numerical nomenclature may be made for brevity and clarity. That is, a feature identified as a "first" element may later be referred to as a "second" element, a "third" element, etc., or may be omitted entirely, and / or a different feature may be referred to as the "first" element. The meaning and / or name in each instance will be apparent to one of ordinary skill in the art.

[0033] Diseases and / or conditions affecting the cardiovascular system are prevalent throughout the world. Traditionally, treatment of the cardiovascular system has often been performed by directly accessing the affected portion of the system. For example, treatment of blockages in one or more coronary arteries has traditionally been treated using coronary artery bypass surgery. As can be readily appreciated, such treatments are highly invasive for the patient and require significant recovery time and / or procedures. More recently, less invasive treatments (e.g., angioplasty) have been developed that allow, for example, blocked coronary arteries to be accessed and treated via percutaneous catheters. Such treatments have gained widespread acceptance among patients and clinicians.

[0034] The heart of some mammals (such as humans) includes four heart valves: the tricuspid valve, the pulmonary valve, the aortic valve, and the mitral valve. Several relatively common pathologies may include or be the result of inefficiency, ineffectiveness, or complete failure of one or more of the valves in the heart. Treating defective heart valves introduces another challenge in that the treatment often requires repair or complete replacement of the defective valve. Such treatments can be very invasive to the patient. Disclosed herein are medical devices that can be used within a portion of the system to diagnose, treat, and / or repair the cardiovascular system, for example, during and / or in conjunction with a TAVI or TAVR procedure, or in place of a TAVI or TAVR procedure in patients unsuitable for such procedures. At least some of the medical devices disclosed herein may be delivered percutaneously, and thus much less invasive to the patient, although other surgical methods and approaches may also be used. The devices disclosed herein may also provide several additional desirable features and advantages, as described in more detail below. For purposes of this disclosure, the following description is directed to the treatment of native aortic valves and is so described for brevity. However, this is not intended to be limiting, and one of ordinary skill in the art will recognize that the following description may also be applied to mitral or other heart valves with no or minimal changes to the structure and / or scope of the present disclosure. Similarly, the medical devices disclosed herein may have applications and uses in other parts of a patient's anatomy, such as, but not limited to, arteries, veins, and / or other body lumens.

[0035] The figures show anatomical structures, selected components and / or locations of a balloon valvuloplasty catheter, and / or methods of using a balloon valvuloplasty catheter. It should be noted that in any given figure, some features of the anatomical structures and / or balloon valvuloplasty catheter may not be shown or may be shown diagrammatically for simplicity. Further details regarding some of the anatomical structures and / or components of the balloon valvuloplasty catheter may be shown in more detail in other figures. Moreover, for clarity, not all examples of some elements or features are shown in each figure.

[0036] 1 shows a schematic, partial cutaway view of a portion of a first heart 10 including an aortic valve 12 having valve cusps 14, as well as certain connected vascular systems, such as an aorta 20 connected to the aortic valve 12 of the first heart 10 by an aortic arch 22, a coronary artery 24, an ostia 23 of the coronary artery 24, and other aortas 26 (e.g., subclavian, carotid, brachiocephalic) extending from the aortic arch 22 to vital viscera. As noted above, for purposes of this disclosure, the following description is directed to use with the aortic valve 12 and is so described for brevity. However, this is not intended to be limiting, and one of ordinary skill in the art will recognize that the following description may also be applied to other heart valves, blood vessels, and / or treatment sites within a patient with no or minimal changes to the structure and / or scope of the present disclosure.

[0037] When providing therapy to a native heart valve, the native heart valve and / or its leaflets may sometimes be calcified and / or narrowed, which may cause and / or worsen certain conditions. For example, when a replacement heart valve implant is prescribed, it may be beneficial to reconstruct the native heart valve anatomy before performing a procedure (e.g., TAVI, TAVR, etc.) to prepare the native heart valve anatomy to accept the replacement heart valve implant. One such approach to reconstruct the native aortic valve is by a balloon aortic valvuloplasty (BAV) procedure. However, the expansion of a balloon within the native aortic valve restricts blood flow through the native aortic valve. Often, such procedures involve "rapid pacing" of the heart to prevent pressure differences within the heart and / or across the native aortic valve from causing damage to the heart and / or other anatomical structures.

[0038] Figure 2 shows the first heart 10 of Figure 1 with a schematic example of a replacement heart valve implant 30 placed in the aortic valve 12 of the first heart 10. In the first heart 10 shown in Figures 1 and 2, the coronary artery 24 is far enough downstream from the aortic valve 12 that the valve leaflets 14 sandwiched between the replacement aortic heart valve implant 30 and the wall of the aorta 20 do not obstruct the ostium 23 of the coronary artery 24. The first heart 10 having the illustrated configuration often leads to successful implantation of the replacement aortic heart valve implant 30. However, not all hearts are the same and anatomical differences may exist.

[0039] FIG. 3 shows a schematic, partial cutaway view of a portion of the second heart 40 including the aortic valve 42 with its valve cusps 44, as well as certain connected vascular systems such as the aorta 50 connected to the aortic valve 42 of the second heart 40 by the aortic arch 52, the coronary arteries 54, the ostium 53 of the coronary arteries 54, and other aortas 56 (e.g., subclavian, carotid, brachiocephalic arteries) that extend from the aortic arch 52 to important internal organs. In the second heart 40 shown in FIG. 3, the coronary arteries 54 are located downstream from the aortic valve 42 by a much shorter distance than in the first heart 10. The second heart 40 may generally function similarly and / or the same as the first heart 10, despite the anatomical differences seen in the figure. However, in some medical procedures, these anatomical differences may have a significant impact on the success or failure of the procedure.

[0040] 4 shows the same replacement aortic heart valve implant 30 positioned within the aortic valve 42 of the second heart 40. As a result of the coronary arteries 54 being located a much shorter distance downstream from the aortic valve 42 than in the first heart 10, the valve cusps 44 obstruct the ostia 53 of the coronary arteries 54 when they are pinched between the replacement aortic heart valve implant 30 and the wall of the aorta 50. In the anatomical configuration as shown in the second heart 40, implantation of the replacement aortic heart valve implant 30 and the subsequent occlusion of the coronary arteries 54, or the resulting occlusion of the coronary arteries 54, even if only partially occluded, can have fatal consequences for the patient.

[0041] 5 illustrates a balloon valvuloplasty catheter 100 that may be used in accordance with the methods disclosed herein and other methods. In some embodiments, the balloon valvuloplasty catheter 100 may be used in a method of preparing a native heart valve of a patient's heart for valve replacement. In some embodiments, the balloon valvuloplasty catheter 100 may be used in a method of repairing a native heart valve of a patient's heart. Other uses and types of procedures are also envisioned.

[0042] The balloon valvuloplasty catheter 100 may include an elongate shaft 110 having a guidewire lumen 112 and a device lumen 114 extending longitudinally therethrough. In at least some embodiments, the guidewire lumen 112 may extend from a proximal end of the elongate shaft 110 to a distal end of the elongate shaft 110. In some embodiments, the guidewire lumen 112 may be sized and configured to slidably receive a guidewire extending therein and / or therethrough. In some embodiments, the guidewire lumen 112 may terminate at its proximal end in a proximal guidewire port. In some embodiments, the proximal guidewire port may be located at the proximal end of the elongate shaft 110. Other configurations are envisioned, including those associated with a single operator exchange (SOE). In some embodiments, the proximal guidewire port may be located at a location distal to the proximal end of the elongate shaft 110.

[0043] The balloon valvuloplasty catheter 100 may include an expandable balloon 120 secured to a distal portion of the elongate shaft 110. The expandable balloon 120 may be configured to transition between a collapsed configuration and an expanded configuration. In some embodiments, the expanded configuration may be referred to and / or interchangeably referred to as an inflated configuration. The expandable balloon 120 may be substantially impermeable to fluids (e.g., gases, liquids, air, water, saline, blood, etc.). In some embodiments, the expandable balloon 120 may be semi-permeable and / or permeable to selected and / or predetermined fluids (e.g., permeable to liquids but not to gases, or vice versa, permeable to liquids but not to semi-solids such as gels, etc.). In some embodiments, the expandable balloon 120 may be formed from a compliant material. In some embodiments, the expandable balloon 120 may be formed from a substantially non-compliant material. The expandable balloon 120 can be configured to expand and / or inflate using an inflation fluid introduced into the interior 122 of the expandable balloon 120 through the elongate shaft 110.

[0044] In some embodiments, the device lumen 114 may terminate at a proximal device port at its proximal end. In some embodiments, the proximal device port may be located at the proximal end of the elongate shaft 110. In some embodiments, the device lumen 114 may be in fluid communication with the interior 122 of the expandable balloon 120. In some embodiments, the distal end of the device lumen 114 opens into the interior 122 of the expandable balloon 120. In some embodiments, the distal end of the device lumen 114 terminates within the interior 122 of the expandable balloon 120.

[0045] In some embodiments, the elongate shaft 110 includes an inflation lumen 116 in fluid communication with the interior 122 of the expandable balloon 120. In some embodiments, the inflation lumen 116 may terminate at an inflation port proximate the proximal end of the elongate shaft 110. In some embodiments, the device lumen 114 defines at least a portion of the inflation lumen 116. For example, within the body portion of the elongate shaft 110, the device lumen 114 and the inflation lumen 116 may be coextensive. In some embodiments, the device lumen 114 is an inflation lumen. In some embodiments, the inflation lumen 116 is fluidly connected to the device lumen 114 distal to the proximal device port.

[0046] The balloon valvuloplasty catheter 100 may include an intravascular ultrasound catheter 130 slidably disposed within the device lumen 114. In at least some embodiments, the device lumen 114 may include a proximal seal 118 configured to engage an outer surface of the intravascular ultrasound catheter 130 to seal the device lumen 114 against leakage and / or contamination. In some embodiments, the intravascular ultrasound catheter 130 may include an ultrasound transducer 132 disposed proximate a distal end of the intravascular ultrasound catheter 130. In some embodiments, the intravascular ultrasound catheter 130 may include an ultrasound transducer 132 disposed at a distal end of the intravascular ultrasound catheter 130. In some embodiments, the distal portion of the elongate shaft 110 may include a notch proximal to the distal end of the elongate shaft 110. The device lumen 114 may terminate and / or terminate at the notch in the elongate shaft 110. The notch in the elongate shaft 110 may be disposed within the interior 122 of the expandable balloon 120. 5, the intravascular ultrasound catheter 130 and an ultrasound transducer 132 disposed proximate the distal end of the intravascular ultrasound catheter 130 may extend into a notch in the elongate shaft 110. The ultrasound transducer 132 may be disposed within the interior 122 of the expandable balloon 120. In at least some embodiments, the ultrasound transducer 132 may be configured to move longitudinally and / or axially within the interior 122 of the expandable balloon 120.

[0047] Intravascular ultrasound (IVUS) is a catheter-based technique that provides high-resolution cross-sectional images of blood vessels or tissues in vivo. IVUS uses ultrasound technology to look from inside the vessel through the surrounding vessels to the outside and visualize the vessel walls. IVUS may be used in coronary arteries to identify the amount of atheromatous plaque that has built up at any particular point in the epicardial coronary artery. IVUS may also allow visualization of the atheroma and / or plaque volume in the vessel walls. In some cases, IVUS can directly quantify the percentage of stenosis and observe the plaque anatomy. IVUS imaging may be performed by cannulation with a catheter that has a miniature transducer that emits high-frequency ultrasound waves, usually in the range of 20-50 megahertz (MHz). As the transducer moves within the vessel or target area, the ultrasound reflections are electronically converted into a cross-sectional image. In some embodiments, IVUS may be used to generate a forward-looking image of the treated area.

[0048] In some embodiments, the intravascular ultrasound catheter 130 can be configured to image tissue surrounding the expandable balloon 120 when the expandable balloon 120 is disposed in situ. In some embodiments, the intravascular ultrasound catheter 130 can be configured to image tissue surrounding the expandable balloon 120 when the expandable balloon 120 is in an expanded configuration in situ.

[0049] In some embodiments, the balloon valvulopaque catheter 100 and / or the elongate shaft 110 may include a first radiopaque marker 140 disposed adjacent a proximal end of the expandable balloon 120 and a second radiopaque marker 142 disposed adjacent a distal end of the expandable balloon 120. In some embodiments, the first radiopaque marker 140 and / or the second radiopaque marker 142 may be fixedly attached to the elongate shaft 110. In some embodiments, the first radiopaque marker 140 and / or the second radiopaque marker 142 may be embedded within the elongate shaft 110. In some embodiments, the first radiopaque marker 140 and / or the second radiopaque marker 142 may be disposed at and / or adjacent the proximal and distal ends of the notches of the elongate shaft 110, respectively. In some embodiments, the first radiopaque marker 140 and / or the second radiopaque marker 142 may be disposed within the interior 122 of the expandable balloon 120. In some embodiments, the first radiopaque marker 140 and / or the second radiopaque marker 142 may be disposed on the exterior of the expandable balloon 120. In at least some embodiments, the first radiopaque marker 140 and the second radiopaque marker 142 may define proximal and distal limits of axial translation of the ultrasound transducer 132.

[0050] Figures 6-10 illustrate embodiments of methods of preparing a native aortic heart valve 72 of a patient's heart 70 for transcatheter aortic valve replacement and / or methods of repairing a native aortic heart valve 72 of a patient's heart 70. As described herein, the patient's heart 70 of Figures 6-10 may be and / or may refer to the heart 10 of Figures 1 and 2 and / or the heart 40 of Figures 3 and 4. Accordingly, the following correspondences will be understood. The native aortic heart valve 72 may be and / or may refer to the aortic valve 12 and / or the aortic valve 42 (or in alternative embodiments, the mitral valve, tricuspid valve, etc.), the native cusp 74 of the native aortic heart valve 72 may be and / or may refer to the cusp 14 and / or the cusp 44, the left ventricle 76 may be and / or may refer to the left ventricle of the heart 10 and / or the heart 40, the aorta 80 may be and / or may refer to the aorta 20 and / or the aorta 50, the left coronary ostium 83 and the right coronary ostium 85 of the coronary artery 84 may be and / or may refer to the left and right instances of the ostium 23 of the coronary artery 24 and / or the ostium 53 of the coronary artery 54, and the other aorta 86 may be and / or may refer to the other aorta 26 and / or the other aorta 56. The disclosed methods may be equally applied to either or other anatomical configurations, unless expressly stated otherwise.

[0051] The method of preparing the native aortic heart valve 72 of the patient's heart 70 for transcatheter aortic valve replacement and / or the method of repairing the native aortic heart valve 72 of the patient's heart 70 may include percutaneously advancing a guidewire 150 through the native aortic heart valve 72 and into the left ventricle 76 of the patient's heart 70. The method of preparing the native aortic heart valve 72 of the patient's heart 70 for transcatheter aortic valve replacement and / or the method of repairing the native aortic heart valve 72 of the patient's heart 70 may include advancing a balloon valvuloplasty catheter 100 over the guidewire 150 to a position adjacent the native aortic heart valve 72. The method of preparing the native aortic heart valve 72 of the patient's heart 70 for transcatheter aortic valve replacement and / or the method of repairing the native aortic heart valve 72 of the patient's heart 70 may include positioning an expandable balloon 120 within the native aortic heart valve 72.

[0052] A method of preparing a native aortic heart valve 72 of a patient's heart 70 for transcatheter aortic valve replacement and / or a method of repairing a native aortic heart valve 72 of a patient's heart 70 may include imaging the left coronary ostium 83, the right coronary ostium 85, and the native cusps 74 of the native aortic heart valve 72 using an intravascular ultrasound catheter 130. In some embodiments, imaging the left coronary ostium 83, the right coronary ostium 85, and the native cusps 74 of the native aortic heart valve 72 using an intravascular ultrasound catheter 130 may include generating cross-sectional or forward-looking images of the left coronary ostium 83, the right coronary ostium 85, and / or the native cusps 74 of the native aortic heart valve 72 using the intravascular ultrasound catheter 130.

[0053] The method of preparing the native aortic heart valve 72 of the patient's heart 70 for transcatheter aortic valve replacement and / or the method of repairing the native aortic heart valve 72 of the patient's heart 70 may include inflating an expandable balloon 120 within the native aortic heart valve 72 of the patient's heart 70. In some embodiments, the method of preparing the native aortic heart valve 72 of the patient's heart 70 for transcatheter aortic valve replacement and / or the method of repairing the native aortic heart valve 72 of the patient's heart 70 may include observing by intravascular ultrasound the position of the native valve cusps 74 of the native aortic heart valve 72 relative to the left coronary ostium 83 and the right coronary ostium 85.

[0054] In some embodiments, the method of preparing the native aortic heart valve 72 of the patient's heart 70 for transcatheter aortic valve replacement and / or the method of repairing the native aortic heart valve 72 of the patient's heart 70 may include adjusting the position of the intravascular ultrasound catheter 130 and / or the ultrasound transducer 132 within the interior 122 of the expandable balloon 120 by axially sliding the intravascular ultrasound catheter 130 relative to the elongate shaft 110. In some embodiments, the method of preparing the native aortic heart valve 72 of the patient's heart 70 for transcatheter aortic valve replacement and / or the method of repairing the native aortic heart valve 72 of the patient's heart 70 may include axially sliding the ultrasound transducer 132 between a proximal end of the notch in the elongate shaft 110 and a distal end of the notch in the elongate shaft 110. In some embodiments, a method of preparing the native aortic heart valve 72 of a patient's heart 70 for transcatheter aortic valve replacement and / or a method of repairing the native aortic heart valve 72 of a patient's heart 70 may include sliding an ultrasound transducer 132 distally within a notch in the elongate shaft 110 and then sliding the ultrasound transducer 132 proximally within a notch in the elongate shaft 110. In some embodiments, a method of preparing the native aortic heart valve 72 of a patient's heart 70 for transcatheter aortic valve replacement and / or a method of repairing the native aortic heart valve 72 of a patient's heart 70 may include sliding an ultrasound transducer 132 distally within an interior 122 of an expandable balloon 120 and then sliding the ultrasound transducer 132 proximally within an interior 122 of an expandable balloon 120.

[0055] In some embodiments, sliding the ultrasound transducer 132 axially within the notch in the elongate shaft 110 and / or within the interior 122 of the expandable balloon 120 may be performed manually by a user. In some embodiments, sliding the ultrasound transducer 132 axially within the notch in the elongate shaft 110 and / or within the interior 122 of the expandable balloon 120 may include using a motorized translation mechanism. In some embodiments, the motorized translation mechanism may be configured to slide the ultrasound transducer 132 axially within the notch in the elongate shaft 110 and / or within the interior 122 of the expandable balloon 120 at a speed of up to 20 millimeters per second (mm / s), up to 15 mm / s, up to 12 mm / s, up to 10 mm / s, up to 7.5 mm / s, up to 5 mm / s, up to 3 mm / s, or another suitable speed commensurate with the imaging mode, intended target, and / or device performance.

[0056] In some embodiments, a method of preparing a native aortic heart valve 72 of a patient's heart 70 for transcatheter aortic valve replacement and / or a method of repairing a native aortic heart valve 72 of a patient's heart 70 may include evaluating the position of the native valve cusps 74 relative to the left coronary artery ostium 83 and the right coronary artery ostium 85 to determine whether the native valve cusps 74 block or at least partially block the left coronary artery ostium 83 and / or the right coronary artery ostium 85 when the expandable balloon 120 is inflated and / or in an expanded configuration as seen in FIG. 7 .

[0057] 8 illustrates an aspect of a portion 200 of a method for preparing a native aortic heart valve 72 of a patient's heart 70 for transcatheter aortic valve replacement and / or a method for repairing a native aortic heart valve 72 of a patient's heart 70. In some embodiments, the method for preparing a native aortic heart valve 72 of a patient's heart 70 for transcatheter aortic valve replacement and / or a method for repairing a native aortic heart valve 72 of a patient's heart 70 may include imaging the native aortic heart valve 72 using an intravascular ultrasound catheter 130 (see reference number 202) to measure the size of the native aortic heart valve 72. In some embodiments, imaging the native aortic heart valve 72 using an intravascular ultrasound catheter 130 may include three-dimensional (3D) visualization of the native aortic heart valve 72. In some embodiments, 3D visualization may be useful and / or enhance the diagnostic capabilities of the intravascular ultrasound catheter 130.

[0058] In some embodiments, imaging the native aortic heart valve 72 using the intravascular ultrasound catheter 130 is performed while the expandable balloon 120 is inflated within the native aortic heart valve 72 as shown in Figure 6. In some embodiments, imaging the native aortic heart valve 72 using the intravascular ultrasound catheter 130 is performed while the expandable balloon 120 is fully inflated within the native aortic heart valve 72 and / or in an expanded configuration as shown in Figure 7. In some embodiments, the method of preparing the native aortic heart valve 72 of a patient's heart 70 for transcatheter aortic valve replacement and / or the method of repairing the native aortic heart valve 72 of a patient's heart 70 may include selecting a replacement aortic heart valve implant 30 (see reference number 204) based on a size of the native aortic heart valve 72 measured by imaging the native aortic heart valve 72 using the intravascular ultrasound catheter 130.

[0059] In some embodiments, the method of preparing the native aortic heart valve 72 of the patient's heart 70 for transcatheter aortic valve replacement and / or the method of repairing the native aortic heart valve 72 of the patient's heart 70 may comprise loading (see reference numeral 206) the selected replacement aortic heart valve implant 30 into a delivery device 160 (e.g., FIG. 9 ). The method of preparing the native aortic heart valve 72 of the patient's heart 70 for transcatheter aortic valve replacement and / or the method of repairing the native aortic heart valve 72 of the patient's heart 70 may further comprise delivering (see reference numeral 208) the replacement aortic heart valve implant 30 to the native aortic heart valve 72.

[0060] In some embodiments, the method of repairing a native aortic heart valve 72 of a patient's heart 70 may further include removing the balloon valvuloplasty catheter 100 while maintaining the guidewire 150 in place within the left ventricle 76 of the patient's heart 70 and in place within the aorta 80. In some embodiments, placement of the replacement aortic heart valve implant 30 may be abandoned, terminated, and / or avoided if one or both of the left coronary ostium 83 and the right coronary ostium 85 are blocked or at least partially blocked by the native valve leaflets 74 when the expandable balloon 120 is inflated and / or in an expanded configuration, as seen in FIG.

[0061] In an embodiment in which a method of preparing a native aortic heart valve 72 of a patient's heart 70 for transcatheter aortic valve replacement and / or a method of repairing a native aortic heart valve 72 of a patient's heart 70 may proceed (e.g., where the patient's heart 70 is anatomically configured, for example, as shown in Figures 1-2), the method may include advancing a delivery device 160 percutaneously over a guidewire 150 within the aorta 80 to the native aortic heart valve 72, as shown in Figure 9. Thereafter, the method of repairing a native aortic heart valve 72 of a patient's heart 70 may include placing a replacement aortic heart valve implant 30 in the native aortic heart valve 72 using the delivery device 160 such that neither the left coronary ostium 83 nor the right coronary ostium 85 are blocked by the native valve cusps 74 when the replacement aortic heart valve implant 30 is placed, as seen in Figure 10 (e.g., Figure 2).

[0062] In some embodiments, the delivery device 160 may include an outer sheath and an inner catheter disposed therein. In some embodiments, the inner catheter may extend at least partially through the outer sheath. In some embodiments, the replacement aortic valve implant 30 may be coupled to the inner catheter and disposed within the lumen of the outer sheath during delivery of the replacement aortic valve implant 30. In some embodiments, a handle may be disposed and / or attached to a proximal end of the delivery device 160 and may include one or more actuation means associated with the handle. In some embodiments, the handle may be configured to manipulate the position of the outer sheath relative to the inner catheter and / or the replacement aortic valve implant 30 and / or to assist in the placement of the replacement aortic valve implant 30. In some embodiments, the delivery device 160 may include a nose cone disposed at its distal end. The delivery device 160 may be configured to slidably receive the guidewire 150 and / or to slidably move over the guidewire 150. In at least some embodiments, the nose cone may have an atraumatic shape.

[0063] During delivery, the replacement aortic valve implant 30 may be positioned in a generally elongated, low-profile "delivery" configuration within an outer sheath coupled to an inner catheter and / or distal to the inner catheter. Once positioned, the outer sheath may be retracted relative to the inner catheter and / or replacement aortic valve implant 30 to expose the replacement aortic valve implant 30. The replacement aortic valve implant 30 may be actuated using a handle to transition the replacement aortic valve implant 30 to a generally expanded, larger profile "deployed" configuration (e.g., expanded but still coupled to the delivery device 160 and / or inner catheter) suitable for implantation within the anatomy. Once the replacement aortic valve implant 30 is properly placed within the anatomical structure, the replacement aortic valve implant 30 may be detached and / or removed from the delivery device 160, and the delivery device 160 can be withdrawn from the vascular system, with the replacement aortic valve implant 30 remaining in place in a "detached" configuration, e.g., functioning as a suitable substitute for the native aortic heart valve 72.

[0064] In some embodiments, the delivery device 160 may include at least one actuator element that detachably connects the replacement aortic valve implant 30 to the handle. In some embodiments, the at least one actuator element may extend distally from the inner catheter to the replacement aortic valve implant 30. In some embodiments, the at least one actuator element may be slidably disposed within and / or slidably extend within the inner catheter. In some embodiments, the at least one actuator element may be used to actuate (i.e., axially or longitudinally translate and / or expand) the replacement aortic valve implant 30 between a “delivery” configuration, a “deployment” configuration, and / or a “detachment” configuration. In some embodiments, the at least one actuator element may include multiple actuator elements, two actuator elements, three actuator elements, four actuator elements, or another suitable or desired number of actuator elements.

[0065] The replacement aortic valve implant 30 may include a plurality of leaflets (e.g., bovine pericardium, polymer, etc.) disposed within an expandable anchor member that is reversibly actuable between an elongated "delivery" configuration and a shortened and / or expanded "deployed" configuration. In some embodiments, the expandable anchor member may form a tubular structure defining a central longitudinal axis and a lumen extending within the expandable anchor member along, parallel to, coaxial with, and / or coincident with the central longitudinal axis from the inflow end of the expandable anchor member to the outflow end of the expandable anchor member. In some embodiments, the expandable anchor member may be and / or include an expandable stent having multiple struts. In some embodiments, the expandable anchor member may be and / or include a braid formed from one or more interwoven filaments (e.g., a single filament, two filaments, etc.). In some embodiments, the expandable anchor member may be self-expanding. In some embodiments, the expandable anchor member may be expanded by mechanical means using a balloon or other suitable expansion methods. Other configurations are envisioned.

[0066] The various components of the balloon valvuloplasty catheter disclosed herein (and / or other elements disclosed herein) and materials that can be used for the various components thereof may include those commonly associated with medical devices. For purposes of simplicity, the following description will refer to a balloon valvuloplasty catheter. However, this is not intended to limit the devices and methods described herein, and the description may apply to other elements, members, components, or devices disclosed herein, such as, but not limited to, the elongate shaft, the expandable balloon, the intravascular ultrasound catheter, the first and second radiopaque markers, the guidewire, the delivery device, and / or elements or components thereof.

[0067] In some embodiments, the balloon valvuloplasty catheters and / or other components disclosed herein may be made from metals, metal alloys, polymers (some examples of which are disclosed below), metal-polymer composites, ceramics, combinations thereof, and the like, or other suitable materials. Some examples of suitable metals and metal alloys include stainless steels, such as 444V, 444L, and 314LV stainless steels; mild steels; nickel-titanium alloys, such as linear elastic and / or superelastic Nitinol; nickel-chromium-molybdenum alloys (e.g., UNS:N06625, such as INCONEL® 625, UNS:N06022, such as HASTELLOY® C-22®, HASTELLOY® C276®, and the like). nickel-copper alloys (e.g., UNS:N04400, such as MONEL® 400, NICKELVAC® 400, NICORROS® 400, etc.); nickel-cobalt-chromium-molybdenum alloys (e.g., UNS:R44035, such as MP35-N®); nickel-molybdenum alloys (e.g., HASTELLOY® ALLOY®, etc.); B2®), other nickel alloys such as other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (e.g., UNS:R44003, such as ELGILOY®, PHYNOX®, etc.); platinum-rich stainless steels; titanium; combinations thereof, etc.; or any other suitable material.

[0068] As mentioned herein, within the family of commercially available nickel-titanium or nitinol alloys, there is a category referred to as "linear elastic" or "non-superelastic" that may be chemically similar to traditional shape memory and superelastic varieties, but may exhibit unique and useful mechanical properties. Linear elastic and / or non-superelastic nitinol may be distinguished from superelastic nitinol in that linear elastic and / or non-superelastic nitinol does not exhibit a substantial "superelastic plateau" or "flag region" in its stress / strain curve as does superelastic nitinol. Instead, in linear elastic and / or non-superelastic nitinol, as recoverable strain increases, stress continues to increase in a substantially linear or somewhat, but not necessarily completely, linear relationship until plastic deformation begins, or at least in a more linear relationship than the superelastic plateau and / or flag region that may be seen in superelastic nitinol. Thus, for purposes of this disclosure, linear elastic and / or non-superelastic nitinol may also be referred to as "substantially" linear elastic and / or non-superelastic nitinol.

[0069] In some cases, linear elastic and / or non-superelastic nitinol may also be distinguishable from superelastic nitinol in that linear elastic and / or non-superelastic nitinol can tolerate up to about 2-5% strain while remaining substantially elastic (e.g., before plastic deformation), whereas superelastic nitinol can tolerate up to about 8% strain before plastic deformation. Both of these materials may be distinguished from other linear elastic materials, such as stainless steel (which may also be distinguished based on its composition), which can only tolerate about 0.2-0.44% strain before plastic deformation.

[0070] In some embodiments, the linear elastic and / or non-superelastic nickel-titanium alloy is an alloy that does not exhibit a martensite / austenite phase change detectable by differential scanning calorimetry (DSC) and dynamic metal thermal analysis (DMTA) analysis over a large temperature range. For example, in some embodiments, the linear elastic and / or non-superelastic nickel-titanium alloy may not have a martensite / austenite phase change detectable by DSC and DMTA analysis within a range of about -60 degrees Celsius (°C) to about 120°C. Thus, the mechanical bending properties of such materials may be nearly inert to the effects of temperature over this very wide range of temperatures. In some embodiments, the mechanical bending properties of the linear elastic and / or non-superelastic nickel-titanium alloy at ambient or room temperature are substantially the same as the mechanical properties at body temperature, for example, in that they do not exhibit a superelastic plateau and / or flag region. In other words, over a wide temperature range, the linear elastic and / or non-superelastic nickel-titanium alloy maintains its linear elastic and / or non-superelastic properties and / or characteristics.

[0071] In some embodiments, the linear elastic and / or non-superelastic nickel-titanium alloy may range from about 50 to about 60 weight percent nickel, with the remainder essentially titanium. In some embodiments, the composition ranges from about 54 to about 57 weight percent nickel. One example of a suitable nickel-titanium alloy is FHP-NT alloy, available from Furukawa Techno Material Co., Ltd., Kanagawa, Japan. Other suitable materials may include ULTANIUM™ (available from Neo-Metrics) and GUM METAL™ (available from Toyota). In some other embodiments, a superelastic alloy, such as superelastic Nitinol, may be used to achieve the desired properties.

[0072] In at least some embodiments, some or all of the balloon valvuloplasty catheters and / or other elements disclosed herein may also be doped with, made of, or include radiopaque materials. A radiopaque material is understood to be a material that can produce a relatively bright image on a fluoroscopy screen or another imaging technique during a medical procedure. This relatively bright image assists the user in determining the location of the balloon valvuloplasty catheters and / or other elements disclosed herein. Some examples of radiopaque materials include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, polymeric materials loaded with radiopaque fillers, and the like. Additionally, other radiopaque marker bands and / or coils may be incorporated into the design of the balloon valvuloplasty catheters and / or other elements disclosed herein to achieve the same results.

[0073] In some embodiments, a degree of magnetic resonance imaging (MRI) compatibility is imparted to the balloon valvuloplasty catheters and / or other elements disclosed herein. For example, the balloon valvuloplasty catheters and / or components or portions thereof may be made of materials that do not substantially distort images and do not cause substantial artifacts (e.g., gaps in images). For example, certain ferromagnetic materials may not be suitable because they may cause artifacts in MRI images. The balloon valvuloplasty catheters or portions thereof may also be made of materials that MRI machines can image. Some materials that exhibit these properties include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS:R44003, such as ELGILOY®, PHYNOX®, etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS:R44035, such as MP35-N®), nitinol, etc., and others.

[0074] In some embodiments, the balloon valvuloplasty catheters and / or other components disclosed herein may be made from or include a polymer or other suitable material. Some examples of suitable polymers include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, e.g., DELRIN® available from DuPont), polyether block esters, polyurethanes (e.g., Polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyetheresters (e.g., ARNITEL® available from DSM Engineering Plastics), ether or ester based copolymers (e.g., butylene / poly(alkylene ether) phthalates and / or other polyester elastomers such as HYTREL® available from DuPont), polyamides (e.g., DURETHAN® or Elf® available from Bayer), and the like. Atochem's CRISTAMID®), elastomeric polyamides, block polyamide / ethers, polyether block amides (PEBA, available, for example, under the trade name PEBAX®), ethylene vinyl acetate copolymers (EVA), silicones, polyethylene (PE), MARLEX® high density polyethylene, MARLEX® low density polyethylene, linear low density polyethylene (e.g., REXELL®), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyether ether ketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), polyparaphenylene terephthalamide (e.g., KEVLAR®), polysulfone, nylon, nylon-12 (e.g., EMS AmericanExamples of suitable materials include GRILAMID® available from Grillon), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefins, polystyrene, epoxies, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS 50A), polycarbonates, ionomers, biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers, polymer / metal composites, and the like. In some embodiments, the sheath can be blended with a liquid crystal polymer (LCP). For example, the mixture can contain up to about 6% LCP.

[0075] In some embodiments, the balloon valvuloplasty catheters and / or other elements disclosed herein may include a woven material disposed on or within the structure. The woven material may be comprised of a biocompatible material, such as a polymeric material or a biomaterial, adapted to promote tissue ingrowth. In some embodiments, the woven material may include a bioabsorbable material. Some examples of suitable woven materials include, but are not limited to, polyethylene glycol (PEG), nylon, polytetrafluoroethylene (PTFE), ePTFE), polyolefin-based materials such as polyethylene, polypropylene, polyester, polyurethane, and / or blends or combinations thereof.

[0076] In some embodiments, the balloon valvuloplasty catheters and / or other elements disclosed herein may include and / or be formed from textile materials. Some examples of suitable textile materials may include synthetic yarns that may be flat, shaped, twisted, textured, pre-shrunk, or unshrunk. Synthetic biocompatible yarns suitable for use in the present disclosure include, but are not limited to, polyesters, including polyethylene terephthalate (PET) polyesters, polypropylene, polyethylene, polyurethanes, polyolefins, polyvinyls, polymethylacetates, polyamides, naphthalene dicarboxylic acid derivatives, natural silk, and polytetrafluoroethylene. Additionally, at least one of the synthetic yarns may be a metal yarn, a glass or ceramic yarn, or a fiber. Useful metal yarns include yarns made from or containing stainless steel, platinum, gold, titanium, tantalum, or Ni-Co-Cr based alloys. The yarns may further include carbon fibers, glass fibers, or ceramic fibers. Desirably, the threads are made from thermoplastic materials, including but not limited to polyester, polypropylene, polyethylene, polyurethane, polynaphthalene, polytetrafluoroethylene, and the like. The threads may be of the multifilament, monofilament, or spun type. The type and denier of the thread selected may be selected to form a biocompatible and implantable prosthesis, and more particularly, a vascular structure, having desirable properties.

[0077] In some embodiments, the balloon valvuloplasty catheters and / or other components disclosed herein may include and / or be treated with suitable therapeutic agents. Some examples of suitable therapeutic agents include antithrombotic agents (such as heparin, heparin derivatives, urokinase, and PPack (dextrophenylalanine proline arginine chloromethyl ketone)); antiproliferative agents (such as enoxaparin, angiopeptin, monoclonal antibodies capable of blocking smooth muscle cell proliferation, hirudin, and acetylsalicylic acid); anti-inflammatory agents (such as dexamethasone, prednisolone, corticosterone, budesonide, estrogen, sulfasalazine, and mesalamine); antitumor / antiproliferative / antimitotic agents (such as paclitaxel, 5-fluorouracil, cisplatin, vinblastine, vincristine, epothilones, endostatin, angiostatin, and thymidine kinase inhibitors); anesthetic agents (such as lidocaine, bupivacaine, and ropivacaine); anticoagulants (such as D-Phe-Pro-Arg chloromethylketone, RGD peptide-containing compounds, heparin, antithrombin compounds, platelet receptor antagonists, antithrombin antibodies, antiplatelet receptor antibodies, aspirin, prostaglandin inhibitors, platelet inhibitors, and tick antiplatelet peptide); vascular cell growth promoters (such as growth factor inhibitors, growth factor receptor antagonists, transcription activators, and translation promoters); vascular cell growth inhibitors (such as growth factor inhibitors, growth factor receptor antagonists, transcription repressors, translation repressors, replication inhibitors, inhibitory antibodies, antibodies against growth factors, bifunctional molecules consisting of growth factors and cytotoxins, bifunctional molecules consisting of antibodies and cytotoxins); cholesterol lowering agents; vasodilators; and agents that interfere with endogenous vasoactive mechanisms.

[0078] It will be understood that the present disclosure is in many respects merely illustrative. Changes may be made in details, particularly in matters of shape, size, and arrangement of steps, without exceeding the scope of the present disclosure. This may include, to the extent appropriate, using any of the features of one exemplary embodiment in other embodiments. The scope of the present disclosure is, of course, defined in the language in which the appended claims are expressed.

Claims

1. an elongate shaft having a guidewire lumen and a device lumen extending longitudinally therethrough, the elongate shaft having a notch proximate a distal end of the elongate shaft; an expandable balloon secured to a distal portion of the elongate shaft; an intravascular ultrasound catheter slidably disposed within the device lumen; Equipped with the device lumen is in fluid communication with an interior of the expandable balloon, the notch in the elongate shaft is disposed within the expandable balloon, and the intravascular ultrasound catheter is configured to extend into the notch. A catheter for balloon valvuloplasty.

2. The balloon valvuloplasty catheter of claim 1 , wherein the intravascular ultrasound catheter is configured to image tissue surrounding the expandable balloon when the expandable balloon is in an expanded configuration.

3. 3. The balloon valvuloplasty catheter of claim 1, wherein the elongate shaft includes an inflation lumen in fluid communication with the interior of the expandable balloon.

4. The balloon valvuloplasty catheter of claim 3 , wherein the device lumen defines at least a portion of the inflation lumen.

5. The balloon valvuloplasty catheter of any one of claims 1 to 4, wherein the device lumen includes a proximal seal configured to engage an outer surface of the intravascular ultrasound catheter.

6. The balloon valvuloplasty catheter of any one of claims 1 to 5, wherein the intravascular ultrasound catheter includes an ultrasound transducer disposed proximate a distal end of the intravascular ultrasound catheter.

7. The balloon valvuloplasty catheter of claim 6 , wherein the ultrasonic transducer is configured for longitudinal movement within the expandable balloon.

8. The balloon valvuloplasty catheter of any one of claims 1 to 7, wherein the device lumen terminates within the interior of the expandable balloon.

9. 9. The balloon valvuloplasty catheter of claim 1, wherein a first radiopaque marker is disposed adjacent to a proximal end of the expandable balloon and a second radiopaque marker is disposed adjacent to a distal end of the expandable balloon.

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