Color changing indicator for detecting damage to catheter balloon

Abstract

A color changing indicator for detecting damage to a catheter balloon is disclosed. An assembly can comprise a delivery apparatus for implanting an implantable medical device, where the delivery apparatus can comprise a shaft and an inflatable balloon coupled to the shaft. The balloon is adapted to receive thereon the implantable medical device in a crimped state. A fluid for introducing into the balloon can be adapted to change a color of a portion of the implantable medical device and / or a portion of the delivery apparatus upon contact with the fluid when the fluid leaks from the balloon. The fluid can be adapted to change a color of the fluid upon contact with air outside the balloon.

Description

Attorney Docket No: THVDL-23679WO01 COLOR CHANGING INDICATOR FOR DETECTING DAMAGE TO CATHETER BALLOON CROSS REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 631,893, filed April 9, 2024, which is incorporated by reference herein in its entirety. FIELD

[0002] The present disclosure relates to color changing indicators for detecting damage to an inflatable catheter balloon. 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, grafts, etc.) 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.

[0004] In a specific example, a prosthetic heart valve can be mounted in a crimped state on the distal end 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 catheter balloon on which the prosthetic valve is mounted, actuating a mechanical actuator that applies an expansion force to the prosthetic valve, or by deploying the prosthetic valve from a sheath of the delivery apparatus so that the prosthetic valve can self-expand to its functional size. Inflatable catheter balloons can be used in some instances to deploy or implant other implantable medical devices, such as for example, stents or grafts. If there is any damage to the ballon, it may not beAttorney Docket No: THVDL-23679WO01 easily perceptible to the user and can lead to balloon failure when inflated. Accordingly, a need exists for detecting damage to an inflatable catheter balloon before an implantation procedure. SUMMARY

[0005] Described herein are prosthetic heart valves, delivery apparatuses, and methods for implanting prosthetic heart valves. Also described herein are devices, assemblies, and methods for detecting damage to an inflatable catheter balloon used in deploying and implanting medical devices, such as for example, prosthetic heart valves, stents, or grafts. The disclosed devices, assemblies, and methods can indicate damage to catheter balloons, for example, during a crimping operation. As such, the devices and methods disclosed herein can, among other things, overcome one or more of the deficiencies of typical prosthetic heart valves, stents and grafts, and their delivery apparatuses.

[0006] An assembly can comprise a delivery apparatus for implanting an implantable medical device, where the delivery apparatus can comprise a shaft and an inflatable balloon coupled to the shaft. In addition to these components, the assembly can further comprise one or more of the components disclosed herein.

[0007] In some examples, the balloon can be adapted to receive thereon the implantable medical device in a crimped state.

[0008] In some examples, the assembly can comprise a fluid for introducing into the balloon.

[0009] In some examples, the fluid can be adapted to change a color of a portion of the implantable medical device upon contact between the portion of the implantable medical device and the fluid when the fluid leaks from the balloon.

[0010] In some examples, the fluid can comprise a colored dye.

[0011] In some examples, the fluid can comprise a solution of saline and the colored dye.

[0012] In some examples, the portion of the implantable medical device that changes color can be a fabric.Attorney Docket No: THVDL-23679WO01

[0013] In some examples, the fabric can be white prior to contact with the fluid that leaks from the balloon and can change to a non-white color upon contact with the fluid that leaks from the balloon.

[0014] In some examples, the portion of the implantable medical device can be coated or impregnated with an agent that can be adapted to change a color upon contact with the fluid.

[0015] In some examples, the fluid can be adapted to change a color of a portion of the delivery apparatus upon contact between the portion of the delivery apparatus and the fluid when the fluid leaks from the balloon.

[0016] In some examples, the portion of the delivery apparatus can be coated or impregnated with an agent that can be adapted to change a color upon contact with the fluid.

[0017] In some examples, the fluid can be adapted to change a color of the fluid that leaks from the balloon upon contact of the fluid with air outside the balloon.

[0018] In some examples, the fluid can comprise a water-soluble dye that undergoes a change in pH when the fluid leaks from the balloon and contacts air outside of the balloon, wherein the change in pH can cause the fluid to change colors.

[0019] In some examples, the agent can comprise anthocyanidin, curcumin, alizarin, shikonin, or combinations thereof.

[0020] In some examples, the dye can comprise anthocyanidin.

[0021] In some examples, the portion of the implantable medical device can be a valve skirt.

[0022] In some examples, the implantable medical device can be a prosthetic valve, a stent, or a graft.

[0023] In some examples, an assembly comprises a delivery apparatus for implanting an implantable medical device, the delivery apparatus comprising a shaft and a balloon coupled to the shaft, wherein the balloon is adapted to receive thereon the implantable medical device in a crimped state; and a fluid for introducing into the balloon, wherein the fluid is adapted to: (i) change a color of a portion of the implantable medical device upon contact between the portionAttorney Docket No: THVDL-23679WO01 of the implantable medical device and the fluid when the fluid leaks from the balloon; (ii) change a color of a portion of the delivery apparatus upon contact between the portion of the delivery apparatus and the fluid when the fluid leaks from the balloon; or (iii) change a color of the fluid that leaks from the balloon upon contact of the fluid with air outside the balloon.

[0024] In some examples, an assembly comprises a prosthetic valve delivery apparatus comprising an inflatable balloon; a fluid disposed inside the balloon; and a prosthetic valve disposed on the balloon, wherein the prosthetic valve comprises a component that changes color upon contact with the fluid when the fluid leaks from the balloon.

[0025] In some examples, an assembly comprises one or more of the components recited in Examples 1-28, 47, and 48 below.

[0026] A method can comprise introducing a fluid into a balloon of a delivery apparatus for an implantable medical device. In addition to these steps, the method can further comprise one or more of the steps disclosed herein.

[0027] In some examples, the method can comprise crimping the implantable medical device around the balloon prior to the act of detecting.

[0028] In some examples, the method can comprise detecting a change in color of a portion of the medical device which indicates that the fluid has leaked from the balloon.

[0029] In some examples, the method can comprise detecting a change in color of a portion of the delivery apparatus which indicates that the fluid has leaked from the balloon.

[0030] In some examples, the method can comprise detecting a change in color of the fluid which indicates that the fluid has leaked from the balloon.

[0031] In some examples, the method can comprise impregnating or coating the portion of the medical device with an agent that is adapted to change a color upon contact with the fluid.

[0032] In some examples, the method can comprise impregnating or coating the portion of the delivery apparatus with an agent that is adapted to change a color upon contact with the fluid.Attorney Docket No: THVDL-23679WO01

[0033] In some examples, the method can comprise waiting a duration of time to detect a change in color.

[0034] In some examples, a method comprises introducing a fluid into a balloon of a delivery apparatus for an implantable medical device and detecting a change in color of a portion of the medical device, a change in color of a portion of the delivery apparatus, or a change in color of the fluid, which indicates that the fluid has leaked from the balloon.

[0035] In some examples, a method comprises one or more of the steps recited in Examples 29- 46 below.

[0036] The various 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

[0037] FIG. 1 is a side view of a prosthetic heart valve, according to an example.

[0038] FIG. 2 is a side view of a delivery apparatus for a prosthetic heart valve, according to an example.

[0039] FIG. 3 is a close-up view of the delivery apparatus and the prosthetic heart valve of FIG. 2, where a catheter balloon of the delivery apparatus contains a fluid.

[0040] FIG. 4 is a close-up view of the delivery apparatus and the prosthetic heart valve of FIG. 3, where a valve skirt of the prosthetic valve has changed color.Attorney Docket No: THVDL-23679WO01 DETAILED DESCRIPTION General Considerations

[0041] 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 various disclosed examples, alone and in various 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.

[0042] 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.

[0043] 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.” 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.Attorney Docket No: THVDL-23679WO01

[0044] As used herein, the term “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 patient’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 patient’s body). The terms “longitudinal” and “axial” refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined.

[0045] As used herein, “e.g.” means “for example,” and “i.e.” means “that is.” Overview of the Disclosed Technology

[0046] Described herein are examples of a delivery apparatus that can be used to navigate a subject’s vasculature to deliver an implantable, expandable medical device (for example, a prosthetic heart valve), tools, agents, or other therapy to a location within the body of a subject. Examples of procedures in which the steerable catheters are useful include neurological, urological, gynecological, fertility (for example, 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; positioning imaging devices and / or components thereof, including ultrasound transducers; and positioning energy sources, for example, for performing lithotripsy, RF sources, ultrasound emitters, electromagnetic sources, laser sources, thermal sources, and the like.

[0047] As introduced above, balloon catheters can be used to expand and deploy implantable medical devices (i.e., prosthetic implants) within portions of a body, for example, within a patient’s vasculature and heart. Examples of implantable medical devices can comprise prosthetic heart valves, stents, and grafts. In some instances, the implantable medical devices can be crimped or assembled onto an inflation balloon (also referred to herein as a “balloon,” a “catheter balloon,” or an “inflatable balloon”) in a compressed state for delivery to and deployment at an implantation site. The balloon can be inflated once the implantable medicalAttorney Docket No: THVDL-23679WO01 device is positioned at the implantation site. The implantable medical device can expand to a deployed state when the balloon inflates. As noted above, in some cases, the balloon can be damaged during the crimping process, which can lead to balloon failure when inflated. Thus, detecting any damage to the balloon incurred while assembling, crimping, and / or securing the implantable medical device onto the balloon is desirable.

[0048] Therefore, a need exists for indicating and / or detecting damage in a balloon prior to inserting the balloon catheter into the patient’s vasculature.

[0049] Described herein are color changing indicators for detecting and signaling damage to catheter balloons and methods of using the color changing indicators. In an exemplary example, an implantable medical device can be a prosthetic heart valve as seen in FIG. 1. FIG. 2 illustrates an example of a delivery apparatus for a prosthetic heart valve, where the delivery apparatus comprises a catheter balloon. The catheter balloon can contain an indicator fluid, as seen in FIG. 3, where the indicator fluid can leak through any tears or openings in the catheter balloon. In an example, the indicator fluid can leak from the balloon and change the color of a portion of a surrounding prosthetic valve, as seen in FIG. 4, where the portion of the prosthetic valve that changes color can be a fabric skirt of the prosthetic valve. Other examples of color indicating fluids will be described in more detail herein below. Examples of the Disclosed Technology

[0050] Prosthetic implants (e.g., prosthetic valves, stents, grafts, etc.) disclosed herein can be radially compressible and expandable between a radially compressed state and a radially expanded state. Thus, the prosthetic implants (also referred to herein as “implantable medical devices”) can be crimped on or retained by an implant delivery apparatus in the radially compressed state while being advanced through a patient’s vasculature on the delivery apparatus. The prosthetic implant can be expanded to the radially expanded state (e.g., a deployed state) once the prosthetic implant reaches an implantation site. It is understood that the prosthetic implants disclosed herein may be used with a variety of implant delivery apparatuses and can be implanted via various delivery procedures, examples of which will be discussed in more detail below.Attorney Docket No: THVDL-23679WO01

[0051] FIG. 1 shows an exemplary prosthetic implant in the form of a prosthetic valve 100, according to an example. Although the examples described herein are primarily directed to prosthetic heart valves, the disclosed devices and methods can be used with various other prosthetic implants, including, for instance, stents and grafts.

[0052] Any of the prosthetic valves disclosed herein are adapted to be implanted in the native aortic annulus, although in other examples they can be adapted to be implanted in the other native annuluses of the heart (the pulmonary, mitral, and tricuspid valves). The disclosed prosthetic valves also can be implanted within vessels communicating with the heart, including a pulmonary artery (for replacing the function of a diseased pulmonary valve, or the superior vena cava or the inferior vena cava (for replacing the function of a diseased tricuspid valve) or various other veins, arteries, and vessels of a patient. The disclosed prosthetic valves also can be implanted within a previously implanted prosthetic valve (which can be a prosthetic surgical valve or a prosthetic transcatheter heart valve) in a valve-in-valve procedure.

[0053] In some examples, the disclosed prosthetic valves can be implanted within a docking or anchoring device that is implanted within a native heart valve or a vessel. For example, the disclosed prosthetic valves can be implanted within a docking device implanted within the pulmonary artery for replacing the function of a diseased pulmonary valve, such as disclosed in U.S. Publication No. 2017 / 0231756, which is incorporated by reference herein. In another example, the disclosed prosthetic valves can be implanted within a docking device implanted within or at the native mitral valve, such as disclosed in PCT Publication No. WO2020 / 247907, which is incorporated by reference herein. In another example, the disclosed prosthetic valves can be implanted within a docking device implanted within the superior or inferior vena cava for replacing the function of a diseased tricuspid valve, such as disclosed in U.S. Publication No. 2019 / 0000615, which is incorporated by reference herein.

[0054] The prosthetic valve 100 can comprise a frame 112, a valvular structure 114, an inner skirt 116, and a perivalvular outer sealing member or outer skirt 118. The prosthetic valve 100 can comprise an inflow end portion 115 and an outflow end portion 119, and an intermediate portion 117 extending therebetween.Attorney Docket No: THVDL-23679WO01

[0055] The valvular structure 114 can comprise a plurality of leaflets 140 collectively forming a leaflet structure. In some examples, the valvular structure 114 can comprise three leaflets 140 arranged in a tricuspid arrangement. However, there can be a greater or fewer number of leaflets 140. The leaflets can be secured to one another at their adjacent sides to form commissures 122 of the valvular structure 114. The lower edge of the valvular structure 114 can have an undulating, curved scalloped shape, and can be secured to the inner skirt 116 by sutures (not shown). In some examples, the leaflets 140 can be formed of pericardial tissue (such as bovine pericardial tissue), biocompatible synthetic materials, or other various suitable natural or synthetic materials as known in the art and described in U.S. Patent No. 6,730,118, which is incorporated by reference herein.

[0056] The frame 112 can be made of any of various suitable plastically-expandable materials (for example, stainless steel, etc.) or self-expanding materials (for example, Nitinol) as known in the art. When constructed of a plastically-expandable material, the frame 112 (and thus the valve 100) can be crimped to a radially compressed state on a delivery catheter and then expanded inside a patient by an inflatable catheter balloon or equivalent expansion mechanism. When constructed of a self-expandable material, the frame 112 (and thus the valve 100) can be crimped to a radially compressed state and restrained in the compressed state by insertion into a sheath or equivalent mechanism of a delivery catheter. Once inside the body, the valve can be advanced from the delivery sheath, which allows the valve to expand to its functional size.

[0057] Suitable plastically-expandable materials that can be used to form the frames disclosed herein (for example, the frame 112) include, metal alloys, polymers, or combinations thereof. Example metal alloys can comprise one or more of the following: nickel, cobalt, chromium, molybdenum, titanium, or other biocompatible metal. In some examples, the frame 112 can comprise stainless steel. In some examples, the frame 112 can comprise cobalt-chromium. In some examples, the frame 112 can comprise nickel-cobalt-chromium. In some examples, the frame 112 comprises a nickel-cobalt-chromium-molybdenum alloy, such as MP35N™ (tradename of SPS Technologies), which is equivalent to UNS R30035 (covered by ASTMAttorney Docket No: THVDL-23679WO01 F562-02). MP35N™ / UNS R30035 comprises 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum, by weight.

[0058] The inner skirt 116 and / or the outer skirt 118 can be wholly or partly formed of any suitable biological material, synthetic material (for example, any of various polymers), or combinations thereof. In some examples, the skirts 116, 118 can comprise a fabric having interlaced yarns or fibers, such as in the form of a woven, braided, or knitted fabric. In some examples, the fabric can have a plush nap or pile. Exemplary fabrics having a plus nap or pile include velour, velvet, velveteen, corduroy, terrycloth, fleece, etc. In some examples, the skirts 116, 118 can comprise a fabric without interlaced yarns or fibers or randomly interlaced yarns or fibers, such as felt or an electrospun fabric. Exemplary materials that can be used for forming such fabrics (with or without interlaced yarns or fibers) include, without limitation, polyethylene (PET), ultra-high molecular weight polyethylene (UHMWPE), polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), polyamide etc. In some examples, the skirts 116, 118 can comprise a non-textile or non-fabric material, such as a film made from any of a variety of polymeric materials, such as PTFE, PET, polypropylene, polyamide, polyetheretherketone (PEEK), polyurethane (such as thermoplastic polyurethane (TPU)), etc. In some examples, the skirts 116, 118 can comprise a sponge material or foam, such as polyurethane foam. In some examples, the skirts 116, 118 can comprise natural tissue, such as pericardium (for example, bovine pericardium, porcine pericardium, equine pericardium, or pericardium from other sources).

[0059] FIG. 2 shows a delivery apparatus 200, according to an example, in the form of a balloon catheter that can be used to implant a prosthetic medical device. In some examples, the delivery apparatus 200 can be used to implant an expandable prosthetic heart valve (for example, the prosthetic valve 100 of FIG. 1, or any of the other prosthetic heart valves described herein, or other types of implants). In some examples, the delivery apparatus 200 can be specifically adapted for use in introducing a prosthetic heart valve into a heart.

[0060] The delivery apparatus 200 in the illustrated example of FIG. 2 comprises a handle 202 and a steerable, outer shaft 204 extending distally from the handle 202. The delivery apparatusAttorney Docket No: THVDL-23679WO01 200 can further comprise an intermediate shaft 206 (also referred to herein as a “balloon shaft”) that extends proximally from the handle 202 and distally from the handle 202, the portion extending distally from the handle 202 also extending coaxially through the outer shaft 204. Additionally, the delivery apparatus 200 can further comprise an inner shaft 208 extending distally from the handle 202 coaxially through the intermediate shaft 206 and the outer shaft 204 and proximally from the handle 202 coaxially through the intermediate shaft 206.

[0061] The outer shaft 204 and the intermediate shaft 206 can be configured to translate (for example, move) longitudinally, along a central longitudinal axis 220 of the delivery apparatus 200, relative to one another to facilitate delivery and positioning of a prosthetic heart valve at an implantation site in a patient’s body.

[0062] The intermediate shaft 206 can include a proximal end portion 210 that extends proximally from a proximal end of the handle 202, to an adaptor 212. A rotatable knob 214 can be mounted on the proximal end portion 210 and can be configured to rotate the intermediate shaft 206 around the central longitudinal axis 220 and relative to the outer shaft 204.

[0063] The adaptor 212 can include a first port 238 configured to receive a guidewire therethrough and a second port 240 configured to receive fluid (for example, inflation fluid) from a fluid source. The second port 240 can be fluidly coupled to an inner lumen of the intermediate shaft 206.

[0064] The balloon shaft 206 can further include a distal end portion that extends distally beyond a distal end of the outer shaft 204 when a distal end of the outer shaft 204 is positioned away from an inflatable catheter balloon 218 (which also referred to herein as a “balloon” or an “inflatable balloon”) of the delivery apparatus 200. A distal end portion of the inner shaft 208 can extend distally beyond the distal end portion of the balloon shaft 206.

[0065] A proximal end 219 of the balloon 218 can be coupled to the distal end portion of the balloon shaft 206 or the inner shaft 208. In some examples, a distal end 221 of the balloon 218 can be coupled to a distal end of the delivery apparatus 200, such as to a nose cone 222 (as shown in FIG. 2). An intermediate portion of the balloon 218 can overlay a valve mounting portion 224 of a distal end portion of the delivery apparatus 200. The valve mounting portionAttorney Docket No: THVDL-23679WO01 224 and the intermediate portion of the balloon 218 can be configured to receive a prosthetic heart valve in a radially compressed (e.g., crimped) state. For example, as shown schematically in FIG. 2, a prosthetic heart valve 250 (which can be any of the prosthetic heart valves described herein) can be mounted around the balloon 218, at the valve mounting portion 224 of the delivery apparatus 200.

[0066] In some examples, the delivery apparatus may comprise a removable cover (not shown) surrounding the balloon 218, wherein the cover can protect the balloon 218 and maintain in place any pleats or folds in the balloon 218 during shipping and storage and / or while preparing the delivery apparatus for an implantation procedure.

[0067] As seen in FIG. 2, the outer shaft 204 can include a distal tip portion 228 mounted on its distal end. The outer shaft 204 and the balloon shaft 206 can be translated axially relative to one another to position the distal tip portion 228 adjacent to a proximal end of the valve mounting portion 224, when the prosthetic heart valve 250 is mounted in the radially compressed state on the valve mounting portion 224 (as shown in FIG. 2) and during delivery of the prosthetic heart valve to the target implantation site. As such, the distal tip portion 228 can be configured to resist movement of the prosthetic heart valve 250 relative to the catheter balloon 218 proximally, in the axial direction, relative to the catheter balloon 218, when the distal tip portion 228 is arranged adjacent to a proximal side of the valve mounting portion 224.

[0068] An annular space can be defined between an outer surface of the inner shaft 208 and an inner surface of the balloon shaft 206 and can be configured to receive fluid from a fluid source 280 via the second port 240 of the adaptor 212. The annular space can be fluidly coupled to a fluid passageway formed between the outer surface of the distal end portion of the inner shaft 208 and an inner surface of the balloon 218. As such, fluid 290 from the fluid source 280 can flow to the fluid passageway from the annular space to inflate the balloon 218 and radially expand and deploy the prosthetic heart valve 250.

[0069] In some examples, prior to crimping the prosthetic valve 250 on the balloon 218 of the delivery apparatus 200, the user can perform a cyclic “de-airing” process that involves pushing an inflation fluid 290 (which can be any fluid described herein) from a fluid source 280 into theAttorney Docket No: THVDL-23679WO01 balloon 218 and then withdrawing the fluid out of the balloon 218. The fluid source 280 can be a syringe and can be fluidly connected to the port 240 via a conduit 292 (for example, flexible tubing). The de-airing process can be more effective when the balloon 218 is allowed to at least partially inflate. However, inflation of the balloon 218 outside of a balloon cover can result in un-folding of the balloon 218, which can inhibit or prevent the balloon 218 from returning to its folded state when the inflation fluid is removed from the balloon 218. The balloon cover, if implemented, can be configured to prevent complete unfolding of the balloon 218 and / or assist the balloon 218 in returning to its fully folded state after the inflation fluid is removed from the balloon 218. Further details regarding the de-airing process and balloon covers are disclosed in WIPO Publication No. WO2022 / 046585, which is incorporated herein by reference.

[0070] Referring back to FIG. 2, an inner lumen of the inner shaft can be configured to receive a guidewire therethrough, for navigating the distal end portion of the delivery apparatus 200 to the target implantation site.

[0071] The handle 202 can include a steering mechanism configured to adjust the curvature of the distal end portion of the delivery apparatus 200. In the illustrated example, for example, the handle 202 includes an adjustment member, such as the illustrated rotatable knob 260, which in turn is operatively coupled to the proximal end portion of a pull wire. The pull wire can extend distally from the handle 202 through the outer shaft 204 and has a distal end portion affixed to the outer shaft 204 at or near the distal end of the outer shaft 204. Rotating the knob 260 can increase or decrease the tension in the pull wire, thereby adjusting the curvature of the distal end portion of the delivery apparatus 200. Further details on steering or flex mechanisms for the delivery apparatus can be found in U.S. Patent No. 9,339,384, which is incorporated by reference herein.

[0072] The handle 202 can further include an adjustment mechanism 261 including an adjustment member, such as the illustrated rotatable knob 262, and an associated locking mechanism including another adjustment member, configured as a rotatable knob 278. The adjustment mechanism 261 is configured to adjust the axial position of the intermediate shaft 206 relative to the outer shaft 204 (for example, for fine positioning at the implantation site). FurtherAttorney Docket No: THVDL-23679WO01 details on the delivery apparatus 200 can be found in PCT Publication No. WO2022 / 046585, which is incorporated by reference herein.

[0073] FIG. 3 illustrates a distal end portion of the delivery apparatus 200 of FIG. 2, specifically showing the prosthetic valve 250 surrounding the balloon 218. As described above, the prosthetic valve 250 can be crimped over the balloon 218 using known techniques and crimping devices for insertion into a body. To detect damage (for example, tears, punctures, or rips) to the balloon 218 that may occur during prosthetic valve crimping or at other times, the balloon 218 can be at least partially filled with a fluid, where leaking fluid can indicate damage to the balloon 218.

[0074] Prior to a crimping procedure, a quantity of fluid 290 from the fluid source 280 can be introduced into the balloon. In some examples, enough fluid 290 is introduced into the balloon 218 to ensure that a substantial portion of an interior volume of the balloon 218 contains the fluid with minimal or no inflation of the balloon such that any pleats or folds in the balloon 218 are maintained. In some examples, a sufficient volume of the fluid 290 is disposed within the balloon 218 such that some fluid 290 can flow into any folds and fill at least most of a length between the proximal end 219 and the distal end 221. As such, the fluid 290 inside the balloon 218 can leak out of the balloon 218 through any holes, tears, or gaps that may be present along its length.

[0075] In some cases, the fluid 290 contained inside the balloon can be residual fluid from a de- airing process as described above. Additionally, or alternatively, the fluid 290 within the balloon 218 can be introduced into the balloon as part of a separate procedure. The fluid 290 can be colorless in some instances and / or comprise a saline or a saline solution.

[0076] In some examples, the fluid 290 can be configured to change a color of a portion of the surrounding structure if a leak occurs. That is, a color change in the surrounding prosthetic implant and / or delivery apparatus can visibly signal to the user that the balloon 218 has a hole or a tear.

[0077] Accordingly, FIG. 3 shows an example of a fluid 300 within the balloon 218 with stippling indicating that the fluid is colored (that is, the fluid has a hue and / or a tint and is notAttorney Docket No: THVDL-23679WO01 colorless or achromatic). In some examples, the fluid 300 can comprise a solution of saline and a colored dye, where the fluid 300 assumes the color of the dye as shown by the stippling in FIG. 3. In this way, the color of the fluid 300 within the balloon 218 can be visible to the user through a wall of the balloon 218. The fluid 300 can be any of various colors, such as blue, red, yellow, green, purple, etc.

[0078] The prosthetic valve 250 shown in FIG. 3 can comprise a skirt 310 (which is an outer skirt in the illustrated example), where the skirt 310 is shown in FIG. 3 without any stippling, indicating that the skirt has a first color, such as white. If the fluid 300 leaks from the inside of the balloon 218 through a rip or a tear in the wall of the balloon 218 during a crimping procedure, it can contact the skirt 310. When the fluid 300 contacts the skirt 310, at least a portion of the skirt 310 can absorb the fluid 300. Due to the dye in the fluid 300, at least a portion of the skirt 310 can change colors from the first color to a second color, as indicated by the stippling in FIG. 4. This change in color enables the user to visibly detect a leak in the balloon 218 and act accordingly, such as by discarding the delivery apparatus and optionally the prosthetic valve.

[0079] The skirt 310 can comprise any material and / or can have any type of construction that absorbs the fluid 300 that leaks from the balloon. For example, the skirt can comprise a fabric. In some examples, the skirt can comprise a sponge or foam material.

[0080] In some examples, in lieu of or in addition to the skirt 310, other components of the surrounding prosthetic implant and / or components of the delivery apparatus can be configured to change colors when in contact with a fluid solution comprising dye, thereby denoting a leak. For example, the prosthetic valve 250 can have an absorbent inner skirt or an absorbent material (for example, a fabric, foam, sponge, etc.) mounted at any convenient location(s) on the frame. In some examples, such absorbent materials can be mounted at any convenient location(s) on the delivery apparatus, such as around or adjacent the balloon 218, shaft 206, and / or the nose cone 222.

[0081] In some examples, a fluid within a balloon (such as for example, the balloon 218 or any other balloon described herein) can comprise saline, or another fluid, and a portion of aAttorney Docket No: THVDL-23679WO01 surrounding prosthetic implant (for example, the skirt 310 of the prosthetic valve 250, or any other portion of a prosthetic implant described herein) can be coated or impregnated with a reactive agent that, when in contact with the fluid, changes color, such as via causing a change in pH of the agent. For example, the skirt 310 (which can comprise a fabric or any skirt construction described herein) of prosthetic valve 250 can be coated or impregnated with a reactive agent. The reactive agent can comprise, for example, anthocyanidin, curcumin, alizarin, shikonin, or combinations thereof. In some examples, the fluid 290 can be colorless (i.e., achromatic, without a hue and / or a tint) when inside the balloon 218. If the colorless fluid leaks from the inside of the balloon 218 through a rip or a tear in the balloon 218 (such as, during crimping of the prosthetic valve), it can contact, and optionally, can be absorbed by, the skirt 310 that is coated or impregnated with the reactive agent. The fluid contacting the reactive agent can cause the agent on the skirt 310 to change colors from a first color to a second color due to a chemical reaction (such as a change in pH of the agent) between the fluid and the reactive agent on or in the skirt 310. As such, a change in color can indicate to the user that the balloon 218 has a leak and requires attention.

[0082] In some examples, the fluid 290 is saline and has a pH of about 5.5. Upon contact of the saline with the agent on the prosthetic valve, the pH of the agent can increase and change colors. In some examples, the saline can include an acidic compound to increase the acidity of the saline in the balloon, which in turn can produce a greater change in pH of the agent when contacted by the saline and a provide quicker and enhanced change in color. In some examples, acidic compounds can comprise citric acid, carbonic acid, hydrochloric acid, or combinations thereof.

[0083] In some examples, other portions or components of a surrounding prosthetic implant (any prosthetic implant described herein, such as for example the prosthetic valves 100 and 250) and / or portions or components of a delivery apparatus (any portion of a delivery apparatus described herein, such as for example the delivery apparatus 200) can be coated and / or impregnated with a reactive agent, where the reactive agent is configured to change color when in contact with a fluid as described above. For example, the outer surface of the balloon, or a portion thereof, can be coated with the agent. In another example, a shaft of the deliveryAttorney Docket No: THVDL-23679WO01 apparatus (for example, shaft 206) and / or the nose cone 222 can be coated or impregnated with the agent. Additionally or alternatively, a frame of the surrounding prosthetic implant can be coated or impregnated with the agent. The fluid, in some instances, may be colored or colorless, so long as the portion of the prosthetic implant or delivery apparatus coated and / or impregnated with the reactive agent change color when in contact with a fluid.

[0084] In some examples, the fluid 290 can be a solution comprising an agent configured to react with an ambient environment (for example ambient air) outside of the balloon, thereby indicating a leak. For example, a solution can comprise an agent sensitive to pH, where the agent can be colorless when dissolved in a fluid within the balloon. When the solution leaks out of a hole or tear in the balloon (such as during crimping of the prosthetic valve), the solution can contact ambient air and change colors due to the environmental change in pH. In some examples, the agent can comprise anthocyanidin, curcumin, alizarin, shikonin, indigo carmine, or combinations thereof. The agent can be added to the fluid 290 in the fluid source 280 for injection into the balloon.

[0085] For example, anthocyanidin can be the reactive agent. Anthocyanidin is water-soluble and can change color with pH. Anthocyanidin can be dissolved in saline, which has a pH of approximately 5.5. In a saline solution within a balloon, the anthocyanidin solution can present as colorless. When in contact with the environment outside of the balloon, that is in the case of a leak, the pH can increase and the solution comprising saline and anthocyanidin can change colors to, for instance, a purple or a blue. If the saline solution comprising anthocyanidin leaks from the inside of the balloon through a rip or a tear in the balloon 218, the user can visibly observe the fluid itself changing colors and detect the leak.

[0086] In another example, the agent can be indigo carmine which, at an acidic pH is a blue- violet color and when oxidized or at a basic pH has a green color. If the saline solution comprising indigo carmine leaks from the inside of the balloon through a puncture, rip, or a tear in the balloon 218, the user can visibly observe the fluid itself changing colors from a blue-violet to green and detect the leak.Attorney Docket No: THVDL-23679WO01

[0087] In some examples, as described above, the color changing indicators (any color changing indictor described herein) can be used to detect damage to a balloon incurred while assembling, crimping, and / or securing an implantable medical device onto the balloon. In other examples, the color changing indicators described herein can be used to detect damage to the balloon prior to a crimping operation. For example, prior to crimping, the user can introduce an amount of a fluid 290, 300 into the balloon to pressurize and at least partially the balloon a sufficient amount that can allow the fluid to leak from any existing punctures or tears in the balloon.

[0088] Introducing a color changing indicator into a delivery apparatus (such as, for example, the delivery apparatus 200 or any other delivery apparatus described herein) comprising an inflatable balloon (such as the balloon 218, or any of other balloon described herein) improves the ability of the user to detect damage to the balloon incurred prior to or while assembling, crimping, and / or securing an implantable medical device (such as the prosthetic valves 100, 250, or any other prosthetic implant described herein) onto the balloon, and take appropriate action. Delivery Techniques

[0089] 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 aortic valve. 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 aAttorney Docket No: THVDL-23679WO01 partial J-sternotomy or right parasternal mini-thoracotomy, and then advanced through the ascending aorta toward the native aortic valve.

[0090] 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.

[0091] 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.

[0092] 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 theAttorney Docket No: THVDL-23679WO01 heart) for implanting the prosthetic valve within the native tricuspid valve, the native pulmonary valve, or the pulmonary artery.

[0093] In all delivery approaches, the delivery apparatus can be advanced over a guidewire previously inserted into a patient’s vasculature. Moreover, the disclosed delivery approaches are not intended to be limited. Any of the prosthetic valves disclosed herein can be implanted using any of various delivery procedures and delivery devices known in the art. Sterilization

[0094] 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 patients, 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 for use in sterilization include, without limitation, gamma radiation, ultra-violet radiation, and electron beam. Examples of chemicals 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

[0095] 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.

[0096] Example 1. An assembly comprising: a delivery apparatus for implanting an implantable medical device, the delivery apparatus comprising a shaft and a balloon coupled to the shaft, wherein the balloon is adapted to receive thereon the implantable medical device in a crimped state; and a fluid for introducing into the balloon, wherein the fluid is adapted to: (i) change a color of a portion of the implantable medical device upon contact between the portionAttorney Docket No: THVDL-23679WO01 of the implantable medical device and the fluid when the fluid leaks from the balloon; (ii) change a color of a portion of the delivery apparatus upon contact between the portion of the delivery apparatus and the fluid when the fluid leaks from the balloon; or (iii) change a color of the fluid that leaks from the balloon upon contact of the fluid with air outside the balloon.

[0097] Example 2. The assembly of any example herein, particularly example 1, wherein the fluid is adapted to change a color of a portion of the implantable medical device upon contact between the portion of the implantable medical device and fluid that leaks from the balloon.

[0098] Example 3. The assembly of any example herein, particularly example 2, further comprising the implantable medical device in the crimped state on the balloon.

[0099] Example 4. The assembly of any example herein, particularly example 3, wherein the portion of the implantable medical device is a fabric.

[0100] Example 5. The assembly of any example herein, particularly example 4, wherein the fabric is white prior to contact with the fluid that leaks from the balloon and changes to a non- white color upon contact with the fluid that leaks from the balloon.

[0101] Example 6. The assembly of any example herein, particularly any one of examples 2-5, wherein the fluid comprises a colored dye.

[0102] Example 7. The assembly of any example herein, particularly example 6, wherein the fluid comprises a solution comprising saline and the colored dye.

[0103] Example 8. The assembly of any example herein, particularly any one of examples 2-5, wherein the portion of the implantable medical device is coated or impregnated with an agent that is adapted to change a color upon contact with the fluid.

[0104] Example 9. The assembly of any example herein, particularly example 8, wherein the agent comprises anthocyanidin, curcumin, alizarin, shikonin, or combinations thereof.

[0105] Example 10. The assembly of any example herein, particularly example 1, wherein the fluid is adapted to change a color of a portion of the delivery apparatus upon contact between the portion of the delivery apparatus and fluid that leaks from the balloon.Attorney Docket No: THVDL-23679WO01

[0106] Example 11. The assembly of any example herein, particularly example 10, wherein the portion of the delivery apparatus is coated or impregnated with an agent that is adapted to change a color upon contact with the fluid.

[0107] Example 12. The assembly of any example herein, particularly example 11, wherein the agent comprises anthocyanidin, curcumin, alizarin, shikonin, or combinations thereof.

[0108] Example 13. The assembly of any example herein, particularly any one of examples 8- 12, wherein the fluid comprises an acidic compound.

[0109] Example 14. The assembly any example herein, particularly example 13, wherein the acidic compound comprises citric acid, carbonic acid, hydrochloric acid, or combinations thereof.

[0110] Example 15. The assembly any example herein, particularly example 1, wherein the fluid is adapted to change a color of the fluid that leaks from the balloon upon contact of the fluid with air outside the balloon.

[0111] Example 16. The assembly any example herein, particularly example 15, wherein the fluid comprises a dye that undergoes a change in pH when the fluid leaks from the balloon and contacts air outside of the balloon, wherein the change in pH causes the fluid to change colors.

[0112] Example 17. The assembly any example herein, particularly example 16, wherein the dye comprises anthocyanidin, curcumin, alizarin, shikonin, indigo carmine, or combinations thereof.

[0113] Example 18. The assembly of any example herein, particularly any one of examples 1- 17, wherein the implantable medical device is a prosthetic valve, a stent, or a graft.

[0114] Example 19. An assembly comprising: a prosthetic valve delivery apparatus comprising an inflatable balloon; a fluid disposed inside the balloon; and a prosthetic valve disposed on the balloon, wherein the prosthetic valve comprises a component that changes color upon contact with the fluid when the fluid leaks from the balloon.Attorney Docket No: THVDL-23679WO01

[0115] Example 20. The assembly any example herein, particularly example 19, wherein the component is a valve skirt.

[0116] Example 21. The assembly any example herein, particularly example 20, wherein the valve skirt comprises a fabric.

[0117] Example 22. The assembly of any example herein, particularly any one of examples 19- 21, wherein the component changes from a white to a non-white color.

[0118] Example 23. The assembly of any example herein, particularly any one of examples 19- 22, wherein the fluid comprises a colored dye.

[0119] Example 24. The assembly of any example herein, particularly any one of examples 19- 23, wherein the component can absorb the fluid that leaks from the balloon to cause the component to change colors.

[0120] Example 25. The assembly of any example herein, particularly any one of examples 19- 22, wherein the component is coated or impregnated with an agent that is adapted to change a color upon contact with the fluid.

[0121] Example 26. The assembly any example herein, particularly example 25, wherein the agent comprises anthocyanidin, curcumin, alizarin, shikonin, or combinations thereof.

[0122] Example 27. The assembly of any example herein, particularly any one of examples 25- 26, wherein the fluid comprises an acidic compound.

[0123] Example 28. The assembly any example herein, particularly example 27, wherein the acidic compound comprises citric acid, carbonic acid, hydrochloric acid, or combinations thereof.

[0124] Example 29. A method comprising: introducing a fluid into a balloon of a delivery apparatus for an implantable medical device; and detecting a change in color of a portion of the implantable medical device, a change in color of a portion of the delivery apparatus, or a change in color of the fluid, which indicates that the fluid has leaked from the balloon.Attorney Docket No: THVDL-23679WO01

[0125] Example 30. The method any example herein, particularly example 29, further comprising detecting a change in color of a portion of the implantable medical device.

[0126] Example 31. The method any example herein, particularly example 30, wherein the portion of the implantable medical device is a fabric and the fabric changes from a white to a non-white color.

[0127] Example 32. The method of any example herein, particularly any one of examples 30- 31, wherein the fluid comprises a solution comprising a colored dye.

[0128] Example 33. The method of any example herein, particularly any one of examples 30- 31, wherein the portion of the implantable medical device is coated or impregnated with an agent that is adapted to change a color upon contact with the fluid.

[0129] Example 34. The method any example herein, particularly example 33, wherein the agent comprises anthocyanidin, curcumin, alizarin, shikonin, or combinations thereof.

[0130] Example 35. The method any example herein, particularly example 29, further comprising detecting a change in color of a portion of the delivery apparatus.

[0131] Example 36. The method any example herein, particularly example 35, wherein the fluid comprises a solution comprising an agent that reacts with the portion of the delivery apparatus to change its color.

[0132] Example 37. The method any example herein, particularly example 35 wherein the portion of the delivery apparatus is impregnated or coated with an agent that is adapted to change a color upon contact with the fluid.

[0133] Example 38. The method any example herein, particularly example 37, wherein the agent comprises anthocyanidin, curcumin, alizarin, shikonin, or combinations thereof.

[0134] Example 39. The method of any example herein, particularly any one of examples 33- 38, wherein the fluid comprises an acidic compound.Attorney Docket No: THVDL-23679WO01

[0135] Example 40. The method any example herein, particularly example 39, wherein the acidic compound comprises citric acid, carbonic acid, hydrochloric acid, or combinations thereof.

[0136] Example 41. The method any example herein, particularly example 29, further comprising detecting a change in color of the fluid.

[0137] Example 42. The method any example herein, particularly example 41, wherein the fluid comprises a solution comprising a dye that undergoes a change in pH when the solution leaks from the balloon and contacts air outside of the balloon, wherein the change in pH causes the fluid to change colors.

[0138] Example 43. The method any example herein, particularly example 42, wherein the dye comprises anthocyanidin, curcumin, alizarin, shikonin, indigo carmine, or combinations thereof.

[0139] Example 44. The method of any example herein, particularly any one of examples 29- 43, further comprising waiting a duration of time to detect a change in color.

[0140] Example 45. The method of any example herein, particularly any one of examples 29- 44, further comprising crimping the implantable medical device around the balloon prior to the act of detecting.

[0141] Example 46. A method comprising sterilizing the prosthetic heart valve, implantable medical device, apparatus, and / or assembly of any example.

[0142] Example 47. A prosthetic heart valve, implantable medical device, apparatus, and / or assembly of any one of examples 1-45, wherein the prosthetic heart valve, implantable medical device, apparatus, and / or assembly is sterilized.

[0143] Example 48. The assembly of any example herein, particularly example 1, wherein the fluid is adapted to change a color of a portion of the delivery apparatus upon contact between the portion of the delivery apparatus and fluid that leaks from the balloon and / or a color of a portion of the implantable medical device upon contact between the portion of the implantable medical device and the fluid that leaks from the balloon,, and wherein the portion of the deliveryAttorney Docket No: THVDL-23679WO01 apparatus and / or the portion of the implantable medical device is coated or impregnated with an agent that is adapted to change a color upon contact with the fluid.

[0144] 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 color changing indicator can be combined with any one or more features of another color changing indicator. As another example, any one or more features of one delivery apparatus can be combined with any one or more features of another delivery apparatus.

[0145] 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.

Claims

Attorney Docket No: THVDL-23679WO01 CLAIMS:

1. An assembly comprising: a delivery apparatus for implanting an implantable medical device, the delivery apparatus comprising a shaft and a balloon coupled to the shaft, wherein the balloon is adapted to receive thereon the implantable medical device in a crimped state; and a fluid for introducing into the balloon, wherein the fluid is adapted to: (i) change a color of a portion of the implantable medical device upon contact between the portion of the implantable medical device and the fluid when the fluid leaks from the balloon; (ii) change a color of a portion of the delivery apparatus upon contact between the portion of the delivery apparatus and the fluid when the fluid leaks from the balloon; or (iii) change a color of the fluid that leaks from the balloon upon contact of the fluid with air outside the balloon.

2. The assembly of claim 1, wherein the fluid is adapted to change a color of a portion of the delivery apparatus upon contact between the portion of the delivery apparatus and fluid that leaks from the balloon and / or a color of a portion of the implantable medical device upon contact between the portion of the implantable medical device and the fluid that leaks from the balloon, and wherein the portion of the delivery apparatus and / or the portion of the implantable medical device is coated or impregnated with an agent that is adapted to change a color upon contact with the fluid.

3. The assembly of claim 2, wherein the agent comprises anthocyanidin, curcumin, alizarin, shikonin, or combinations thereof.

4. The assembly of any one of claims 2-3, wherein the fluid comprises an acidic compound.Attorney Docket No: THVDL-23679WO01 5. The assembly of claim 1, wherein the fluid is adapted to change a color of the fluid that leaks from the balloon upon contact of the fluid with air outside the balloon.

6. The assembly of claim 5, wherein the fluid comprises a dye that undergoes a change in pH when the fluid leaks from the balloon and contacts air outside of the balloon, wherein the change in pH causes the fluid to change colors.

7. The assembly of any one of claims 1-6, wherein the implantable medical device is a prosthetic valve, a stent, or a graft.

8. An assembly comprising: a prosthetic valve delivery apparatus comprising an inflatable balloon; a fluid disposed inside the balloon; and a prosthetic valve disposed on the balloon, wherein the prosthetic valve comprises a component that changes color upon contact with the fluid when the fluid leaks from the balloon.

9. The assembly of claim 8, wherein the component is a valve skirt.

10. The assembly of any one of claims 8-9, wherein the fluid comprises a colored dye.

11. The assembly of any one of claims 8-9, wherein the component is coated or impregnated with an agent that is adapted to change a color upon contact with the fluid.

12. The assembly of claim 11, wherein the agent comprises anthocyanidin, curcumin, alizarin, shikonin, or combinations thereof.

13. The assembly of any one of claims 11-12, wherein the fluid comprises an acidic compound.Attorney Docket No: THVDL-23679WO01 14. The assembly of claim 13, wherein the acidic compound comprises citric acid, carbonic acid, hydrochloric acid, or combinations thereof.

15. A method comprising: introducing a fluid into a balloon of a delivery apparatus for an implantable medical device; and detecting a change in color of a portion of the implantable medical device, a change in color of a portion of the delivery apparatus, or a change in color of the fluid, which indicates that the fluid has leaked from the balloon.

16. The method of claim 15, further comprising detecting a change in color of a portion of the implantable medical device.

17. The method of claim 15, further comprising detecting a change in color of a portion of the delivery apparatus.

18. The method of claim 15, further comprising detecting a change in color of the fluid.

19. The method of any one of claims 15-18, further comprising waiting a duration of time to detect a change in color.

20. The method of any one of claims 15-19, further comprising crimping the implantable medical device around the balloon prior to the act of detecting.

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