Prosthetic heart valve inflation apparatus

Abstract

An inflation apparatus is provided for applying an outward radial force to a prosthetic heart valve. The inflation apparatus includes a first balloon positioned in a first section of the prosthetic heart valve. The first balloon is in contact with an interior surface of the first section. The inflation apparatus includes an anchor positioned in a second section of the prosthetic heart valve. The anchor contacts an interior surface of the second section when the anchor is in an expanded state and prevents relative movement along the longitudinal axis between the anchor and the prosthetic heart valve. A catheter extends through a waist section of the prosthetic heart valve between the first balloon and the anchor. The catheter includes a hollow chamber in fluid communication with the first balloon. Methods of dilating a heart valve prosthesis are provided.

Description

PROSTHETIC HEART VALVE INFLATION APPARATUSCROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 625,730, filed January 26, 2024, the entire content of which is incorporated herein by reference.FIELD

[0002] The present disclosure relates generally to a prosthetic heart valve assembly and, more particularly, to an inflation apparatus for positioning within a heart valve prosthesis.BACKGROUND

[0003] It is known to provide a prosthetic heart valve assembly for implanting a heart valve prosthesis within a target site of the vasculature of a patient. The heart valve prosthesis can be moved from a radially-contracted position to a radially-expanded position. However, expansion of the heart valve prosthesis can be difficult.SUMMARY

[0004] The following presents a simplified summary of the disclosure to provide a basic understanding of some aspects described in the detailed description.

[0005] In aspects, an inflation apparatus is provided for dilating a prosthetic heart valve comprising an annular frame extending along a longitudinal axis between an inflow end and an outflow end. The frame comprises a plurality of struts and is configured to be adjustable between a radially-collapsed position and a radially- expanded position. The frame comprises a first section at the inflow end, a second section at the outflow end, and a waist section positioned between the first section and the second section. A valve prosthesis comprises at least one leaflet attached to the plurality of struts. The inflation apparatus comprises a first balloon configured to be positioned in the first section, the first balloon configured to be pressurized from a deflated state to an inflated state. The first balloon comprises a first balloon diameter in the inflated state such that the first balloon is configured to be in contact with aninterior surface of the first section. The inflation apparatus comprises an anchor configured to be positioned in the second section. The anchor is movable between a first anchor diameter when the anchor is in a contracted state, and a second anchor diameter when the anchor is in an expanded state. The first anchor diameter is less than the second anchor diameter. The anchor contacts an interior surface of the second section when the anchor is in the expanded state and prevents relative movement along the longitudinal axis between the anchor and the prosthetic heart valve. A catheter is configured to extend through the waist section between the first balloon and the anchor. The catheter comprises a hollow chamber in fluid communication with the first balloon.

[0006] In aspects, the inflation apparatus further comprises a filter extending substantially perpendicular to the longitudinal axis. The filter is positioned within an interior region of the anchor through which the catheter extends.

[0007] In aspects, the anchor comprises a first anchor length and the first anchor diameter when the anchor is in a contracted state, and a second anchor length and the second anchor diameter when the anchor is in an expanded state . The first anchor length is greater than the second anchor length.

[0008] In aspects, the anchor extends between a first longitudinal end and a second longitudinal end. The first longitudinal end is attached to the catheter in a fixed axial position relative to the catheter. The second longitudinal end is configured to move relative to the catheter to move the anchor between the expanded state and the contracted state.

[0009] In aspects, the anchor comprises a first anchor portion and a second anchor portion spaced apart and extending between the first longitudinal end and the second longitudinal end. A gap is defined between the first anchor portion and the second anchor portion.

[0010] In aspects, an inflation apparatus is provided for dilating a prosthetic heart valve comprising an annular frame extending along a longitudinal axis between an inflow end and an outflow end. The frame comprises a plurality of struts and is configured to be adjustable between a radially-collapsed position and a radially- expanded position. The frame comprises a first section at the inflow end, a second section at the outflow end, and a waist section positioned between the first section and the second section. A valve prosthesis comprises at least one leaflet attached to the plurality of struts. The inflation apparatus comprises a first balloon configured to bepositioned in the first section. The first balloon is configured to be pressurized from a deflated state to an inflated state. The first balloon comprises a first balloon diameter in the inflated state such that the first balloon is configured to be in contact with an interior surface of the first section. The inflation apparatus comprises a second balloon configured to be positioned in the second section. The second balloon is configured to be pressurized from a deflated state to an inflated state. The second balloon comprises a second balloon diameter in the inflated state such that the second balloon is configured to be in contact with an interior surface of the second section and prevent relative movement along the longitudinal axis between the second balloon and the prosthetic heart valve. The inflation apparatus comprises a catheter configured to extend through the waist section between the first balloon and the second balloon. The catheter comprises a first hollow chamber in fluid communication with the first balloon and a second hollow chamber in fluid communication with the second balloon.

[0011] In aspects, the first balloon and the second balloon are spaced a distance apart such that the first balloon defines a first interior space that is separate from a second interior space of the second balloon. The catheter attaches the first balloon to the second balloon.

[0012] In aspects, the second hollow chamber of the catheter circumferentially surrounds the first hollow chamber of the catheter.

[0013] In aspects, one or more of the first balloon or the second balloon comprises one of a toroidal shape, a spiral shape, a spherical shape, a conical shape, or a cross shape comprising a first segment that is angled relative to a second segment.

[0014] In aspects, the inflation apparatus comprises a filter extending substantially perpendicular to the longitudinal axis. The filter is attached to the second balloon.

[0015] In aspects, an inflation apparatus is provided for dilating a prosthetic heart valve comprising an annular frame extending along a longitudinal axis between an inflow end and an outflow end. The frame comprises a plurality of struts and is configured to be adjustable between a radially-collapsed position and a radially- expanded position. The frame comprises a first section at the inflow end, a second section at the outflow end, and a waist section positioned between the first section and the second section. A valve prosthesis comprises at least one leaflet attached to the plurality of struts. The inflation apparatus comprises a first balloon configured to be positioned in the first section. The first balloon is configured to be pressurized from adeflated state to an inflated state. The first balloon comprises a first balloon diameter in the inflated state such that the first balloon is configured to be in contact with an interior surface of the first section. The inflation apparatus comprises a catheter attached to the first balloon and comprising a first hollow chamber in fluid communication with the first balloon.

[0016] In aspects, the first balloon comprises a first wall that defines a first enclosed volume, and a second wall that surrounds the first wall and defines a second enclosed volume between the first wall and the second wall. The first enclosed volume separated from the second enclosed volume.

[0017] In aspects, the first balloon comprises one or more passageways extending through the first balloon substantially parallel to the longitudinal axis.

[0018] In aspects, the first balloon comprises a first region and a second region along the longitudinal axis. The first region comprises a reinforcement material and the second region comprises a compliant material.

[0019] In aspects, the first balloon comprises a first region comprising the first balloon diameter such that the first region is configured to be in contact with the interior surface of the first section. The first balloon comprises a second region configured to be positioned in the second section. The second region is configured to be pressurized from a deflated state to an inflated state. The second region comprises a second balloon diameter in the inflated state such that the second region is configured to be in contact with an interior surface of the second section. The first region and the second region are contiguous and in fluid communication.

[0020] In aspects, a collar circumferentially surrounds the first region. The collar comprises a non-compliant material that is different than the first region comprising a compliant material.

[0021] In aspects, methods of applying an outward radial force to a heart valve prosthesis positioned at a treatment site within a patient are provided. The heart valve prosthesis comprises a first section at an inflow end of the heart valve prosthesis, a second section at an outflow end of the heart valve prosthesis, and a waist section positioned between the first section and the second section. The heart valve prosthesis is positioned such that the first section is within an annulus at the treatment site. Methods comprise positioning an inflation apparatus within a central lumen of the heart valve prosthesis, the inflation apparatus comprising a first balloon positioned in the firstsection. Methods comprise anchoring a portion of the inflation apparatus to contact an interior surface of the heart valve prosthesis to prevent relative movement along a longitudinal axis between the inflation apparatus and the heart valve prosthesis. Methods comprise inflating the first balloon such that the first balloon contacts an interior of the first section to increase a diameter of the first section.

[0022] In aspects, the anchoring comprises radially expanding a portion of the inflation apparatus to contact the second section such that the inflation apparatus is in frictional engagement with the second section.

[0023] In aspects, the anchoring occurs prior to the inflating of the first balloon.

[0024] In aspects, the anchoring comprises inflating a second balloon that contacts the second section.

[0025] Additional features and advantages of the aspects disclosed herein will be set forth in the detailed description that follows, and in part will be clear to those skilled in the art from that description or recognized by practicing the aspects described herein, including the detailed description which follows, the claims, as well as the appended drawings. It is to be understood that both the foregoing general description and the following detailed description present aspects intended to provide an overview or framework for understanding the nature and character of the aspects disclosed herein. The accompanying drawings are included to provide further understanding and are incorporated into and constitute a part of this specification. The drawings illustrate various aspects of the disclosure, and together with the description explain the principles and operations thereof.BRIEF DESCRIPTION OF THE DRAWINGS

[0026] These and other features, aspects and advantages are better understood when the following detailed description is read with reference to the accompanying drawings, in which:

[0027] FIG. 1 schematically illustrates example aspects of a transcatheter heart valve prosthesis in accordance with aspects of the disclosure;

[0028] FIG. 2 illustrates a top-down view of the transcatheter heart valve prosthesis in accordance with aspects of the disclosure;

[0029] FIG. 3 illustrates a side view of a delivery assembly for delivering the transcatheter heart valve prosthesis in accordance with aspects of the disclosure;

[0030] FIG. 4 illustrates a side view of the delivery assembly for delivering the transcatheter heart valve prosthesis in accordance with aspects of the disclosure;

[0031] FIG. 5 illustrates an introducer sheath in accordance with aspects of the disclosure;

[0032] FIG. 6 illustrates an introducer sheath in accordance with aspects of the disclosure;

[0033] FIG. 7 schematically illustrates a side view of a transcatheter heart valve prosthesis positioned at a treatment site in accordance with aspects of the disclosure;

[0034] FIG. 8 illustrates an example of an inflation apparatus in accordance with aspects of the disclosure;

[0035] FIG. 9 illustrates an example of an inflation apparatus in accordance with aspects of the disclosure;

[0036] FIG. 10 illustrates an example of an inflation apparatus with an anchor in accordance with aspects of the disclosure;

[0037] FIG. 11 illustrates an example of an inflation apparatus with an anchor and a balloon engaging a valve prosthesis in accordance with aspects of the disclosure;

[0038] FIG. 12 illustrates an example of an inflation apparatus with a fdter in accordance with aspects of the disclosure;

[0039] FIG. 13 illustrates an example of an inflation apparatus with a fdter in accordance with aspects of the disclosure;

[0040] FIG. 14 illustrates an example of an inflation apparatus comprising a single balloon in accordance with aspects of the disclosure;

[0041] FIG. 15 illustrates an example of an inflation apparatus comprising a balloon and collar in accordance with aspects of the disclosure;

[0042] FIG. 16 illustrates an example of an inflation apparatus comprising at least one balloon in accordance with aspects of the disclosure;

[0043] FIG. 17 illustrates an example of an inflation apparatus comprising two balloons in accordance with aspects of the disclosure;

[0044] FIG. 18 illustrates an example of an inflation apparatus comprising two balloons in accordance with aspects of the disclosure;

[0045] FIG. 19 illustrates an example of an inflation apparatus with an anchor and a balloon engaging a valve prosthesis in accordance with aspects of the disclosure;

[0046] FIG. 20 illustrates an example of an inflation apparatus with an anchor and a balloon engaging a valve prosthesis in accordance with aspects of the disclosure;

[0047] FIG. 21 illustrates an example of an inflation apparatus comprising an anchor balloon in accordance with aspects of the disclosure;

[0048] FIG. 22 illustrates an example of an inflation apparatus comprising two balloons in accordance with aspects of the disclosure;

[0049] FIG. 23 illustrates an example of an inflation apparatus comprising two balloons in accordance with aspects of the disclosure;

[0050] FIG. 24 illustrates an example of an inflation apparatus comprising two balloons in accordance with aspects of the disclosure;

[0051] FIG. 25 illustrates an example of an inflation apparatus comprising two balloons in accordance with aspects of the disclosure;

[0052] FIG. 26 illustrates an example of an inflation apparatus positioned within a sheath in accordance with aspects of the disclosure;

[0053] FIG. 27 illustrates an example of an inflation apparatus after being removed from the sheath in accordance with aspects of the disclosure;

[0054] FIG. 28 illustrates an example of an inflation apparatus comprising one or more passageways in accordance with aspects of the disclosure;

[0055] FIG. 29 illustrates an example of an inflation apparatus comprising one or more passageways in accordance with aspects of the disclosure;

[0056] FIG. 30 illustrates an example of an inflation apparatus comprising a balloon with a plurality of walls in accordance with aspects of the disclosure;

[0057] FIG. 31 illustrates an example of an inflation apparatus comprising a reinforced section in accordance with aspects of the disclosure; and

[0058] FIG. 32 illustrates an example of an inflation apparatus comprising a reinforced section in accordance with aspects of the disclosure.DETAILED DESCRIPTION

[0059] Aspects will now be described more fully hereinafter with reference to the accompanying drawings in which example aspects are shown. Whenever possible, the same reference numerals are used throughout the drawings to refer to the same or like parts. However, this disclosure may be embodied in many different forms and should not be construed as limited to the aspects set forth herein.

[0060] As used herein, the term “about” means that amounts, sizes, formulations, parameters, and other quantities and characteristics are not, and need not be, exact, but may be approximate and / or larger or smaller, as desired, reflecting tolerances, conversion factors, rounding off, measurement error and the like, and other factors known to those of skill in the art.

[0061] Ranges can be expressed herein as from “about” one value, and / or to “about” another value. When such a range is expressed, aspects include from the one value to the other value. Similarly, when values are expressed as approximations by use of the antecedent “about,” it will be understood that the value forms another aspect. It will be further understood that the endpoints of each of the ranges are significant both in relation to the other endpoint, and independently of the other endpoint.

[0062] Directional terms as used herein - for example up, down, right, left, front, back, top, bottom, upper, lower, etc. - are made only with reference to the figures as drawn and are not intended to imply absolute orientation.

[0063] Unless otherwise expressly stated, it is in no way intended that any methods set forth herein be construed as requiring that its steps be performed in a specific order, nor that with any apparatus, specific orientations be required. Accordingly, where a method claim does not actually recite an order to be followed by its steps, or that any apparatus claim does not actually recite an order or orientation to individual components, or it is not otherwise specifically stated in the claims or description that the steps are to be limited to a specific order, or that a specific order or orientation to components of an apparatus is not recited, it is in no way intended that an order or orientation be inferred in any respect. This holds for any possible non-express basis for interpretation, including matters of logic relative to arrangement of steps, operational flow, order of components, or orientation of components; plain meaning derived from grammatical organization or punctuation, and; the number or type of aspects described in the specification.

[0064] As used herein, the singular forms "a," "an," and "the" include plural references unless the context clearly dictates otherwise. Thus, for example, reference to “a” component includes aspects having two or more such components, unless the context clearly indicates otherwise.

[0065] The word “exemplary,” “example,” or various forms thereof are used herein to mean serving as an example, instance, or illustration. Any aspect or design describedherein as “exemplary” or as an “example” should not be construed as preferred or advantageous over other aspects or designs. Furthermore, examples are provided solely for purposes of clarity and understanding and are not meant to limit or restrict the disclosed subject matter or relevant portions of this disclosure in any manner. It can be appreciated that a myriad of additional or alternate examples of varying scope could have been presented but have been omitted for purposes of brevity.

[0066] As used herein, the terms “comprising,” “including,” and variations thereof shall be construed as synonymous and open-ended, unless otherwise indicated. A list of elements following the transitional phrases comprising or including is a nonexclusive list, such that elements in addition to those specifically recited in the list may also be present.

[0067] The terms “substantial,” “substantially,” and variations thereof as used herein are intended to represent that a described feature is equal or approximately equal to a value or description. For example, a “substantially planar” surface is intended to denote a surface that is planar or approximately planar. Moreover, “substantially” is intended to denote that two values are equal or approximately equal. The term “substantially” may denote values within about 10% of each other, for example, within about 5% of each other, or within about 2% of each other.

[0068] Modifications may be made to the instant disclosure without departing from the scope or spirit of the claimed subject matter. Unless specified otherwise, “first,” “second,” or the like are not intended to imply a temporal aspect, a spatial aspect, an ordering, etc. Rather, such terms are merely used as identifiers, names, etc. for features, elements, items, etc. For example, a first end and a second end generally correspond to end A and end B or two different ends.

[0069] Unless otherwise indicated, the terms “distaf’and “proximal” are used in the following description with respect to a position or direction relative to the treating clinician. “Distal” and “distally” are positions distant from or in a direction away from the clinician, and “proximal” and “proximally” are positions near or in a direction toward the clinician. In addition, the term “self-expanding” may be used in the following description with reference to one or more valve or stent structures of the prostheses hereof and is intended to convey that the structures are shaped or formed from a material that can be provided with a mechanical memory to return the structure from a compressed or constricted delivery configuration to an expanded deployedconfiguration or vice versa. Non-exhaustive exemplary self-expanding materials include stainless steel, a pseudo-elastic metal such as a nickel titanium alloy or nitinol, various polymers, or a so-called super alloy, which may have a base metal of nickel, cobalt, chromium, or other metal. Mechanical memory may be imparted to a wire or stent structure by thermal treatment to achieve a spring temper in stainless steel, for example, or to set a shape memory in a susceptible metal alloy, such as nitinol. Various polymers that can be made to have shape memory characteristics may also be suitable for use in aspects hereof to include polymers such as polynorborene, transpolyisoprene, styrene-butadiene, and polyurethane. As well poly L-D lactic copolymer, oligo caprylactone copolymer and poly cyclo-octine can be used separately or in conjunction with other shape memory polymers.

[0070] Diseases associated with heart valves, such as those caused by damage or a defect, can include stenosis and valvular insufficiency or regurgitation. For example, valvular stenosis causes the valve to become narrowed and hardened which can prevent blood flow to a downstream heart chamber from occurring at the proper flow rate and may cause the heart to work harder to pump the blood through the diseased valve. Valvular insufficiency or regurgitation occurs when the valve does not close completely, allowing blood to flow backwards, thereby causing the heart to be less efficient. A diseased or damaged valve, which can be congenital, age-related, drug- induced, or in some instances, caused by infection, can result in an enlarged, thickened heart that loses elasticity and efficiency. Some symptoms of heart valve diseases can include weakness, shortness of breath, dizziness, fainting, palpitations, anemia and edema, and blood clots which can increase the likelihood of stroke or pulmonary embolism. Symptoms can often be severe enough to be debilitating and / or life threatening.

[0071] Heart valve prostheses have been developed for repair and replacement of diseased and / or damaged heart valves. Such heart valve prostheses can be percutaneously delivered and deployed at the site of the diseased heart valve through catheter-based delivery systems. Such heart valve prostheses generally include a frame or stent and a prosthetic valve mounted within the frame. Such heart valve prostheses are delivered in a radially compressed or crimped configuration so that the heart valve prosthesis can be advanced through the patient’s vasculature. Once positioned at thetreatment site, the heart valve prosthesis is expanded to engage tissue at the diseased heart valve region to, for instance, hold the heart valve prosthesis in position.

[0072] FIGS. 1 and 2 illustrate an example transcatheter heart valve prosthesis 10. The delivery assemblies described herein may be used with the transcatheter heart valve prosthesis 10 and / or other transcatheter heart valve prostheses. The transcatheter heart valve prosthesis 10 is illustrated to facilitate description of the disclosure. The following description of the transcatheter heart valve prosthesis 10 is merely exemplary in nature and is not intended to limit the invention or the application and uses of the invention.

[0073] FIGS. 1 and 2 illustrate a side view and a top / end view, respectively, of the transcatheter heart valve prosthesis 10. The transcatheter heart valve prosthesis 10 includes a radially-expandable frame or stent 15 and a prosthetic valve 20. The frame 15 of the transcatheter heart valve prosthesis 10 supports the prosthetic valve 20 within an interior of the frame 15. In the example transcatheter heart valve prosthesis 10 shown in FIGS. 1 and 2, the frame 15 is self-expandable. However, this is not meant to be limiting, and the frame 15 can be balloon-expandable or mechanically expandable in other embodiments. In some embodiments, the transcatheter heart valve prosthesis 10 may be delivered to and implanted at a treatment site within a patient to replace any of an aortic valve, a pulmonic valve, a mitral valve, and a tricuspid valve. The valve to be replaced may be a native valve or a previously-implanted prosthetic valve, such as a failed surgical replacement valve or a failed transcatheter valve. The prosthesis shown herein is described with reference to an aortic valve, with the inflow end at the bottom and outflow end at the top. In aspects where the prosthesis is used in a valve where blood flows in the opposite direction (e.g., mitral or tricuspid valve), the inflow and outflow ends may be considered reversed.

[0074] The prosthetic valve 20 includes at least one leaflet 21 disposed within and secured to the frame 15. In the embodiment shown in FIGS. 1 and 2, the prosthetic valve 20 includes exactly three leaflets 21, as shown in FIG. 2. However, this is not meant to be limiting, as the prosthetic valve 20 may include more or fewer leaflets 21. The valve leaflets 21 open and close to regulate flow through the transcatheter heart valve prosthesis 10.

[0075] As shown in FIG. 1, the transcatheter heart valve prosthesis 10 includes an inflow end 11 and an outflow end 12. The prosthetic leaflets 21 are attached to theframe 15 at commissures 25 such that when pressure at the inflow end 11 exceeds pressure at the outflow end 12, the prosthetic leaflets 21 open to allow blood flow through the heart valve prosthesis 10 from the inflow end 11 to the outflow end 12. When the pressure at the outflow end 12 exceeds pressure at the inflow end 11, the prosthetic leaflets 21 close to prevent blood flow from the outflow end 12 to the inflow end 11. Accordingly, the at least one leaflet (e.g., the prosthetic leaflets 21) can be attached to the plurality of struts 16, for example, by being directly attached to the plurality of struts 16 at the commissures 25, or by being indirectly attached to the plurality of struts 16, for example, by being attached to a skirt, a commissure bracket, or other structure (e.g., mechanical actuator) that is attached to the plurality of struts 16. In aspects, the heart valve prosthesis 10 can comprise one or more attachment members 24 (e.g., paddles) positioned at an end, for example, the outflow end 12. The attachment members 24 can be received within pockets of a spindle 38 (e.g., illustrated in FIG. 4), such that the spindle 38 and the attachment members 24 can interact to facilitate loading of the transcatheter heart valve prosthesis 10 and, in aspects, allow for possible recapture of the transcatheter heart valve prosthesis 10 during the deployment process.

[0076] The frame 15 of the transcatheter heart valve prosthesis 10 further includes a plurality of struts 16 that are arranged to form a plurality of openings or cells 18 arranged circumferentially around a longitudinal axis LA of the transcatheter heart valve prosthesis 10 and longitudinally to form a tubular structure defining a central lumen of the transcatheter heart valve prosthesis 10. For example, the frame 15 can extend along the longitudinal axis LA between the inflow end 11 and the outflow end 12. The frame 15 is configured to secure the prosthetic valve 20 within the central lumen of the frame 15 and to secure the transcatheter heart valve prosthesis 10 in place in the vasculature of the patient. The struts 16 are defined herein as the elongated wire segments of the frame 15. Struts 16 come together to form crowns 17 or nodes 19, as can be seen in FIG. 1. The frame 15 of the heart valve prosthesis 10 includes a plurality of cells 18 defined as the spaces between the plurality of crowns 17, the plurality of nodes 19, and the plurality of struts 16. The frame 15, and, thus, the plurality of struts 16, can be adjustable between a radially-collapsed position and a radially-expanded position.

[0077] In the example embodiment shown in FIG. 1, the plurality of cells 18 may be diamond-shaped. In the example embodiment shown, the plurality of cells include a plurality of first cells 18 and, in aspects, access cells (e.g., an access cell 23). In particular, the access cells may be larger than the first cells 18 and can provide access to one or more coronary arteries when the transcatheter heart valve prosthesis 10 is implanted in the patient. FIG. 1 illustrates an example of an access cell 23, with the struts 16 at the access cell 23 illustrated with dashed lines to show that the struts 16 may not be present at the access cell 23, thus allowing for the access cell 23 to be larger than the first cells 18. The access cells can have an enlarged area relative or compared to the first cells 18. In some embodiments the transcatheter heart valve prosthesis 10 may include an outer skirt extending circumferentially around an outer circumference of the stent 15 at or near the inflow end 11 to prevent paravalvular leakage of blood around the outside of the transcatheter heart valve prosthesis 10 once implanted in the patient.

[0078] FIGS. 3 and 4 show schematically side views of a transcatheter heart valve delivery assembly 30 (e.g., “delivery assembly”) for delivering and deploying a transcatheter heart valve prosthesis (e.g., transcatheter heart valve prosthesis 10) according to embodiments hereof. One skilled in the art will realize that FIGS. 3 and 4 illustrate one example of a delivery assembly 30 and that components illustrated in FIGS. 3 and 4 may be removed and / or additional components may be added. The delivery assembly 30 includes a distal end 31, a proximal end 32, and a handle 33. The handle 33 enables a physician to manipulate a distal portion of the delivery assembly 30 and includes actuators for moving parts of the delivery assembly 30 relative to other parts. In the delivery assembly 30, an outer shaft 34 is coupled to an actuator 39 of the handle 33 for moving the outer shaft 34 relative to an inner shaft 36.

[0079] A distal portion of the outer shaft 34, referred to as a capsule 35, is configured to surround a transcatheter heart valve prosthesis (e.g., transcatheter heart valve prosthesis 10) during delivery to the treatment site (e.g., a native heart valve) and is retracted from the transcatheter heart valve prosthesis to expose the transcatheter heart valve prosthesis such that it self-expands (in self-expanding embodiments). In this way, the capsule 35 is in frictional engagement with the heart valve prosthesis 10. The inner shaft 36 can be coupled to the handle 33 (e.g., by being directly connected and in contact with the handle 33, or by being indirectly connected to the handle 33with intermediate structures between the inner shaft 36 and the handle 33) and movement of the handle 33 can translate to movement of the inner shaft 36 and a distal tip or nosecone 37 coupled to a distal end of the inner shaft 36. The inner shaft 36 and distal tip or nosecone 37 may also be translated relative to the outer shaft 34 and the handle 33 via a tip retractor. In the embodiment shown, the inner shaft 36 includes a retainer or spindle 38 for receiving the paddles (e.g., attachment members 24) of the transcatheter heart valve prosthesis 10.

[0080] When the actuator 39 is actuated, the actuator 39 moves the outer shaft 34 and the capsule 35 relative to the inner shaft 36, as shown in FIG. 4. As known to those skilled in the art, when the delivery assembly 30 is in position such that the transcatheter heart valve prosthesis 10 is at the desired position at the treatment site in the patient’s vasculature, the actuator 39 is actuated (e.g., rotated) to move the capsule 35 relative to the inner shaft 36 and the transcatheter heart valve prosthesis 10 disposed between the inner shaft 36 and the capsule 35, thereby enabling the transcatheter heart valve prosthesis 10 to deploy via self-expansion at the treatment site and release from the retainer 38, as shown in FIG. 4 (without showing the transcatheter heart valve prosthesis 10).

[0081] Minimally invasive percutaneous interventional procedures, including endovascular procedures, require access to the venous or arterial system. In general, it is desirable to make the smallest incision point with the shortest tissue contact time when entering the body. Small incisions and short tissue contact time generally lead to improved patient outcomes, less complications, and less trauma to the vessels or organs being accessed, as well as less trauma to the skin and tissue through which the access point is created. Access is required for various medical procedures that deliver or implant structural elements (such as heart valves, heart valve repair devices, occluders, grafts, electrical stimulators, leads, etc.) percutaneously. Some procedures employ relatively large devices that require relatively large sheaths to deliver the devices to the intended site within the body. With such procedures, access site trauma can occur, often resulting in vessel damage, excessive bleeding, increased case time, increased risk of infection, and increased hospitalization time. To reduce access trauma, physicians try to use the smallest devices possible and place the smallest sheath size. This can be problematic, however, if during the procedure the physician discovers a larger device is needed. This leads to a need to upsize the sheath, which is a lengthy procedure andleads to increased risk to the patient. Expandable sheaths can be expanded within the body and thus do not require removal to upsize.

[0082] Expandable sheath designs may be regionally or locally expansive to selectively and temporarily expand when the device is passing through a region of the sheath and to retract or recover when the device is not passing or has already passed through the sheath. Embodiments disclosed herein may be employed with an expandable introducer sheath that may solve these and other issues that contribute to vascular trauma. The expandable introducer sheath is described with respect to percutaneous access for transcatheter heart valve repair or replacement, and it should be understood that one or more features of the expandable introducer sheath may be employed alone or in combination for other medical procedures requiring percutaneous access, including but not limited to placement of stents, angioplasty, removal of arterial or venous calcification, and pre -dilatation or post-dilatation.

[0083] Various embodiments disclosed herein may include an introducer sheath that has a selectively expandable diameter to allow for the passage of a relatively larger device therethrough and further is configured to return to its original diameter upon passage of the device. The various embodiments may reduce damage to surrounding tissues by reducing contact with those tissues and by eliminating the need to exchange sheaths of different sizes. As a result, these embodiments can reduce procedure time, vascular trauma, bleeding, and the resulting risk of infection and other complications.

[0084] FIGS. 5 and 6 depict one embodiment of an introducer sheath 50 positioned through an incision 60 in the skin 65 of a patient and into a vessel 40 of a patient. The sheath 50 has a tubular shaft 55 and a proximal hub 56 with a hemostatic seal and a luer lock 57. FIG. 5 shows the sheath 50 positioned in the vessel 40 in its normal, unexpanded state, while FIG. 6 shows the sheath 50 positioned in the vessel 40 with a delivery device 75 delivering another device 70 that is being advanced through the sheath 50 such that the tubular shaft 55 expands or deforms at the location where the device 70 is passing through. The shaft 55 expands at expanded region 58 when the device 70 passes through and then retracts or recovers to its original diameter after the device 70 moves past or is removed from the shaft 55. Thus, the tubular shaft 55 is configured to be expandable and retractable.

[0085] In certain embodiments, the expandability of the shaft 55 (and any shaft described according to any embodiment set forth herein) is achieved via the elasticityof the shaft 55, which can result in the shaft 55 being either self-expandable or selfexpanding or mechanically expandable or mechanically expanding. For purposes of this application, self-expandable means that the shaft 55 is configured to expand to a predetermined or nominal diameter automatically (without any type of actuation, mechanical or otherwise). Further, for purposes of this application, mechanically expandable means that the shaft 55 is configured to expand when a positionable medical device is positioned through the shaft 55. That is, the device itself that is being passed through the shaft 55 causes the expansion of the shaft 55, as depicted in FIG. 6. Alternatively, the expandable characteristics of the shaft 55 can be caused by something other than elasticity.

[0086] After passage of the device, the shaft 55 is configured to be contractable, retractable, or recoverable to its original, unexpanded state as depicted in FIG. 5. The retractability can be, in certain embodiments, achieved by the elasticity of the shaft 55, which can result in the shaft 55 being either self-retractable or self-retracting, self- recoverable, or self-contractable, or mechanically retractable or mechanically retracting, mechanically recoverable, or mechanically contractable. For purposes of this application, self-retractable means that the shaft 55 is configured to retract to a predetermined or nominal diameter automatically (without any type of actuation, mechanical or otherwise). Further, for purposes of this application, mechanically retractable means that the shaft 55 is configured to retract when a device or component is used to cause the shaft 55 to retract or recover. Alternatively, the retractable characteristics of the shaft 55 can be caused by something other than elasticity.

[0087] For purposes of this application, any device that can be positioned through an introducer sheath according to any embodiment disclosed or contemplated herein can be referred to as a positionable medical device or insertable medical device. Such devices include guidewires, dilators, delivery devices (for delivery and / or placement of structural elements such as heart valves, heart valve repair devices, occluders, grafts, electrical stimulators, leads, etc.), guide catheters, guiding sheaths, diagnostic catheters, stent delivery systems, balloon catheters, and other known vascular devices. Other devices can include non-vascular devices such as scopes and other common surgical instruments. Further, the introducer sheath is configured to receive tissues or organs. Thus, as one non-limiting example, the introducer sheath 50 is described as being anexpandable introducer sheath 50 for introduction of a delivery assembly 30 including a transcatheter heart valve prosthesis 10.

[0088] FIG. 7 illustrates the heart valve prosthesis 10 at a treatment site 701 within a patient’s vasculature. In aspects, the treatment site 701 can comprise a location of a native aortic annulus (hereinafter “annulus”) 703 of a native heart valve, for example, the annulus of a patient’s left ventricle. The treatment site 701 can comprise one or more native valve leaflets 705 and corresponding native sinuses 707. In some instances, paravalvular leakage can occur when blood travels through a gap 709 around the outside of the transcatheter heart valve prosthesis 10, with the gap 709 formed between the transcatheter heart valve prosthesis 10 and the annulus 703. To avoid paravalvular leakage, the heart valve prosthesis 10 can be radially expanded such that an outer radial surface of the heart valve prosthesis 10 can contact the annulus 703 and / or the native valve leaflets 705, thus reducing or eliminating the gap 709 and causing the blood to flow through the central lumen of the heart valve prosthesis 10. The frame 15 of the heart valve prosthesis 10 can comprise an asymmetric hourglass shape with a first section 713 at the inflow end 11 , a second section 715 at the outflow end 12, and a waist section 717 positioned between the first section 713 and the second section 715. In aspects, the first section 713 can comprise a first diameter 721 and the second section 715 can comprise a second diameter 723, with the second diameter 723 greater than the first diameter 721. Additionally, in some embodiments the transcatheter heart valve prosthesis 10 may include an outer skirt extending circumferentially around an outer circumference of the frame 15 at or near the inflow end 11 to prevent paravalvular leakage of blood around the outside of the transcatheter heart valve prosthesis 10 once implanted in the patient.

[0089] FIG. 8 illustrates a perspective view of an inflation apparatus 801 that can be positioned within the heart valve prosthesis 10 to facilitate dilation and radial expansion of the heart valve prosthesis 10 and / or fracture of an index valve. For example, upon being positioned at the treatment site 701, in aspects, the heart valve prosthesis 10 may be partially radially-expanded but not fully radially-expanded, such that the gap 709 may be present. To assist in fully radially-expanding the heart valve prosthesis 10, after the prosthesis 10 is placed at the treatment site 701, the inflation apparatus 801 can be positioned within the central lumen of the heart valve prosthesis10 to apply an outward radial force to the frame 15 to cause the heart valve prosthesis 10 to fully radially-expand (e.g., post-dilatation).

[0090] In addition or alternatively, the inflation apparatus 801 may be employed to apply an outward radial force to a native annulus or to a previously-implanted index valve prior to placement of the heart valve prosthesis 10 to prepare the treatment site 701 for placement of the heart valve prosthesis 10 (e.g., pre-dilatation). The inflation apparatus 801 may be employed to apply an outward radial force to one or more of the frame 15, the annulus 703, and the native leaflets 705, either independently or simultaneously. Outward radial expansion of the inflation apparatus 801 may also loosen, crack, or break calcification that may have accumulated on or around the treatment site 701 (e.g., calcified leaflets 705). By applying force to the calcification deposits, the inflation apparatus 801 may soften (e.g., increase or restore the elasticity of) the treatment site 701, thereby enabling the heart valve prosthesis 10 to expand (e.g., self-expand) more-fully and seal the annulus 703, reducing or eliminating risk of paraval vular leakage. In aspects, the inflation apparatus 801 can be employed pre or post placement of the heart valve prosthesis 10 to alter the shape and / or size of the treatment site 701 as well as the shape and / or size of the heart valve prosthesis 10. For example, in aspects, the inflation apparatus 801 may be employed with a pre-dilatation or a post-dilation procedure to expand a native annulus 701 and / or a heart valve prosthesis 10 from a non-circular (e.g., elliptical) shape to a more circular shape. Without intending to be bound by theory, it is believed that for some patients, a circular annulus may provide better hemodynamic function as compared to the relative hemodynamic function of a non-circular annulus. Outward radial expansion with the inflation apparatus 801 may also increase the effective orifice area (EOA) at the treatment site 701, further improving hemodynamics . In aspects, the inflation apparatus 801 (and other inflation apparatuses disclosed herein) can further be employed to fracture a previously-implanted heart valve prosthesis, for example, prior to implanting a new or redo heart valve prosthesis. For example, in aspects, the inflation apparatus 801 (and other inflation apparatuses disclosed herein) can be employed to fracture a surgical prosthetic index valve and / or a transcatheter prosthetic index valve. Previously-implanted prosthetic heart valves may endothelialize over time rendering the radial stiffness of the previously-implanted prosthetic heart valve stiffer than when the valve was first implanted. By fracturing a previously implanted prosthetic heartvalve with the inflation apparatus 801 (e.g., mechanically bending or breaking one or more components of the valve by application of force causing stress), the previously- implanted valve may expand, creating a larger treatment site 701 in which to place the new or redo prosthetic valve and may also decrease in radial stiffness (e.g., become more elastic), enabling better implantation, paravalvular sealing, and hemodynamics of the new or redo prosthetic valve as compared to the relative paravalvular sealing and hemodynamics of a non-fractured, endothelialized prosthetic index valve.

[0091] The inflation apparatus 801 can extend along an axis 802 and may comprise a first balloon 803 and an anchor 809. The first balloon 803 is illustrated in an inflated state in FIG. 8, and the anchor 809 is illustrated in an expanded state in FIG. 8. However, to facilitate movement (e.g., delivery, retraction, etc.) of the inflation apparatus 801 through the patient’s vasculature to and from the heart valve prosthesis 10), the first balloon 803 can move between the inflated state and a deflated state (e.g., illustrated in FIG. 9), and the anchor 809 can move between the expanded state and a contracted state (e.g., illustrated in FIG. 9).

[0092] The first balloon 803 can be positioned in the first section 713 of the heart valve prosthesis 10 and can comprise a first balloon diameter 805 in the inflated state. In this way, the first balloon 803 can be in contact with an interior surface 901 (e.g., illustrated in FIGS. 9-11) of the first section 713 when the first balloon 803 is in the inflated state. The first balloon 803 can comprise several shapes and sizes to facilitate expansion of the first section 713. For example, the first balloon 803 can comprise one or more walls that can surround and bound an interior chamber of the first balloon 803. For example, the first balloon 803 can comprise a first wall 811, a second wall 813, and an intermediate wall 815. The first wall 811, the second wall 813, and the intermediate wall 815 can circumferentially surround the axis 802 and may be positioned in an end- to-end configuration along the axis 802. The intermediate wall 815 can extend between the first wall 811 and the second wall 813, with the first wall 811 on one side of the intermediate wall 815, and the second wall 813 on an opposing side of the intermediate wall 815. The first wall 811 can define one end of the first balloon 803 while the second wall 813 can define an opposing end of the first balloon 803. In aspects, the intermediate wall 815 can form a maximum diameter of the first balloon 803 (e.g., comprising the first balloon diameter 805), with the first wall 811 and the second wall 813 tapered from (e.g., comprising a gradually decreasing cross-sectional size) theintermediate wall 815. The walls 811, 813, 815 may be substantially continuous and, in aspects, may be a one-piece formed or composite material. In aspects, one or more of the walls 811, 813, 815 may comprise a non-compliant material, for example, polyester or nylon when used to as part of a bioprosthetic valve fracture. However, for a post implant dilatation, the one or more of the walls 811, 813, 815 may comprise either a non-compliant or a semi-compliant material.

[0093] The anchor 809 can be positioned in the second section 715 and can engage an interior surface 903 (e.g., illustrated in FIGS. 9-11) of the second section 715 to limit movement of the inflation apparatus 801 along the axis 802 relative to the heart valve prosthesis 10. For example, the anchor 809 may be movable between a first anchor diameter 905 (e.g., illustrated in FIG. 9) when the anchor is in a contracted state (e.g., illustrated in FIG. 9), and a second anchor diameter 821 when the anchor 809 is in an expanded state (e.g., illustrated in FIG. 8). The first anchor diameter 905 is less than the second anchor diameter 821. In the expanded state, the anchor 809 can comprise an anchor length 823 (e.g., second anchor length 823).

[0094] The inflation apparatus 801 can comprise a catheter 827 that can extend through the waist section 717 and can extend between the first balloon 803 and the anchor 809. In aspects, the catheter 827 can extend partially or completely through the anchor 809 and the first balloon 803, such that the catheter 827 can function to attach the first balloon 803 to the anchor 809. The catheter 827 can comprise a hollow chamber 829 that extends through the catheter 827, with the hollow chamber 829 in fluid communication with the first balloon 803. In this way, a fluid source (e.g., positioned at an exterior of the patient), can be attached to, and in fluid communication with, the catheter 827. By being in fluid communication, the fluid source can deliver fluid (e.g., saline mixed with a contrasting agent, etc.) through the hollow chamber 829 and to the first balloon 803. The fluid can cause the first balloon 803 to be pressurized from the deflated state (e.g., illustrated in FIG. 9) to the inflated state. The catheter 827 can comprise a flexible shaft that can house a guidewire to facilitate movement within the patient’s vasculature.

[0095] FIG. 9 illustrates a side view of the inflation apparatus 801 and the heart valve prosthesis 10 as the inflation apparatus 801 is being delivered, with the first balloon 803 in the deflated state and the anchor 809 in the contracted state. As illustrated, in the deflated state, the first balloon 803 comprises a minimum cross-sectional size, for example, a balloon diameter that is less than the first balloon diameter 805 illustrated in FIG. 8. Likewise, in the contracted state, the anchor 809 comprises a first anchor diameter 905 (e.g., a minimum cross-sectional size) and a first anchor length 907. The first anchor diameter 905 may be less than the second anchor diameter 821 illustrated in FIG. 8, and the first anchor length 907 may be greater than the second anchor length 823 illustrated in FIG. 8.

[0096] The anchor 809 can extend between a first longitudinal end 911 and a second longitudinal end 913, with the first longitudinal end 911 and the second longitudinal end 913 attached to the catheter 827. In aspects, the first longitudinal end 911 can be attached to the catheter 827 in a fixed axial position relative to the catheter 827. In this way, the first longitudinal end 911 may not move (e.g., along the axis 802) relative to the catheter 827. In aspects, the first longitudinal end 911 can be adjacent to the first balloon 803 and / or may be attached to an end of the first balloon 803. The second longitudinal end 913 can be attached to the catheter 827 while being configured to move relative to the catheter 827 to cause the anchor 809 to move between the expanded state and the contracted state. For example, the second longitudinal end 913 can move axially (e.g., along the axis 802) relative to the catheter 827, for example, by sliding. In aspects, the second longitudinal end 913 can define a hollow bore through which the catheter 827 extends to allow for the second longitudinal end 913 to move. When the second longitudinal end 913 is in a first position (e.g., illustrated in FIG. 9), the second longitudinal end 913 is at a maximum separating distance from the first longitudinal end 911, and the anchor 809 comprises the first anchor length 907 and the first anchor diameter 905. The second longitudinal end 913 can move toward the first longitudinal end 911 such that when the second longitudinal end 913 is in a second position (e.g., illustrated in FIG. 8), the second longitudinal end 913 is at a reduced separating distance from the first longitudinal end 911, and the anchor 809 comprises the second anchor length 823 and the second anchor diameter 821.

[0097] FIG. 10 illustrates the inflation apparatus 801 with the anchor 809 in the expanded state. For example, the inflation apparatus 801, while in the deflated / contracted state of FIG. 9, can be moved through a patient’s vasculature to the heart valve prosthesis 10. The inflation apparatus 801 can be moved to the position illustrated in FIG. 9 such that the first balloon 803 is in the first section 713 and the anchor 809 is in the second section 715. Upon being moved to this position, theinflation apparatus 801 can be inflated / expanded. For example, with reference to FIG. 10, initially, the anchor 809 can move from the contracted position of FIG. 9 to the expanded position of FIG. 10. To move to the expanded position, the second longitudinal end 913 can be moved (e.g., by being controlled by a portion of the delivery assembly 30) relative to the catheter 827 in a direction toward the first longitudinal end 911. For example, a collar (e.g., adjacent to the second end 913) can be attached to a tube that is controllable by a handle of the delivery assembly 30. The physician can operate the handle / de livery assembly 30 to cause the tube to move axially, which can actuate the anchor 809, thus causing the anchor 809 to radially- expand. For example, in aspects, the tube can be moved in a distal direction toward the first balloon 803, which can reduce the length of the anchor 809 and cause radial expansion of the anchor 809. As the second longitudinal end 913 moves toward the first longitudinal end 911, the anchor 809 can radially expand while moving from the contracted state to the expanded state. The second longitudinal end 913 can continue to move, causing radial expansion of the anchor 809, at least until the anchor 809 contacts the interior surface 903 of the second section 715. The anchor 809 can comprise the second anchor diameter 821 and the second anchor length 823 when the anchor 809 is in the expanded state and in contact with the interior surface 903.

[0098] In aspects, the anchor 809 can comprise one or more anchor portions that extend longitudinally along the axis 802 between the first longitudinal end 911 and the second longitudinal end 913. The one or more anchor portions can be attached at one end to the first longitudinal end 911 and at an opposing end to the second longitudinal end 913. In aspects, the anchor 809 can comprise a first anchor portion 1001 and a second anchor portion 1003 that are spaced apart and extend between the first longitudinal end 911 and the second longitudinal end 913. A gap 1005 is defined between the first anchor portion 1001 and the second anchor portion 1003, with the gap 1005 extending between the anchor portions 1001, 1003 along the axis 802. In this way, as the anchor 809 moves to the expanded state, the first anchor portion 1001 and the second anchor portion 1003 can radially expand, and the gap 1005 between the anchor portions 1001, 1003 can increase in size. The first anchor portion 1001 can comprise a first anchor tip 1007 that is the region of the first anchor portion 1001 that has experienced the greatest radial expansion. Likewise, the second anchor portion 1003 can comprise a second anchor tip 1009 that is the region of the second anchorportion 1003 that has experienced the greatest radial expansion. The first anchor tip 1007 and the second anchor tip 1009 can be positioned at about the same axial location (e.g., along the axis 802) and substantially at a midpoint of the anchor 809. The anchor 809 can comprise other anchor portions and anchor tips that are substantially identical to the anchor portions 1001, 1003 and anchor tips 1007, 1009 illustrated and described herein. The anchor portions 1001, 1003, etc. can be arranged circumferentially around the axis 802, with a gap (e.g., substantially identical to the gap 1005) positioned between adjacent and neighboring anchor portions.

[0099] In operation, when the anchor 809 is moved to the expanded state, the anchor portions 1001, 1003, in particular, the anchor tips 1007, 1009, can be received within separate cells 18 of the heart valve prosthesis 10. For example, the first anchor tip 1007 can be received within a first cell 1013 of the plurality of cells 18, and the second anchor tip 1009 can be received within a second cell 1015 of the plurality of cells 18. The other anchor tips can be received within other cells in a substantially identical manner. As such, due to the anchor tips 1007, 1009 being received within the cells 1013, 1015, the anchor 809 can be fixed to the interior surface 903 of the second section 715, which can limit the anchor 809 from moving (e.g., both rotationally about the axis 802 and axially along the axis 802) relative to the heart valve prosthesis 10. Accordingly, by moving the anchor 809 to the expanded state, the inflation apparatus 801 is limited from moving relative to the heart valve prosthesis 10 due to the engagement between the anchor 809 and the second section 715. That is, the anchor 809 can contact the interior surface 903 of the second section 715 when the anchor 809 is in the expanded state to prevent relative movement along the longitudinal axis 802 between the anchor 809 and the prosthetic heart valve 10.

[0100] Referring to FIG. 11, after the anchor 809 has moved to the expanded state in engagement with the second section 715 of the heart valve prosthesis 10, the first balloon 803 can be pressurized from the deflated state (e.g., illustrated in FIGS. 9-10) to the inflated state (e.g., illustrated in FIGS. 8 and 11). For example, by being pressurized, the first balloon 803 can radially expand to the first balloon diameter 805. To pressurize the first balloon 803, the fluid can be delivered through the hollow chamber 829 of the catheter 827 to an interior of the first balloon 803. The first balloon 803 can be pressurized and inflated at least until the first balloon 803 contacts the interior surface 901 of the first section 713 to increase the diameter of the first section713. For example, the intermediate wall 815 can radially-expand and contact the interior surface 901. The intermediate wall 815 can radially expand the inflow crowns and at least the first nodes of the frame. However, the first balloon 803 will not contact the valve 20 or leaflets 21. Likewise, the anchor 809 will not contact the valve 20 or leaflets 21. Rather, an intermediate region (e.g., adjacent to the end 911) may be located between the first balloon 803 and the anchor 809, with the intermediate region comprising a reduced or minimized diameter. That is, the intermediate region may comprise a reduced diameter as compared to the diameters of the first balloon 803 and anchor 809. As such, the intermediate region can extend through the valve 20 without radially-expanding the valve 20 or leaflets 21.

[0101] As the first balloon 803 is pressurized and inflated, the inflation apparatus 801 is limited from moving relative to the heart valve prosthesis 10 due to the anchor 809 remaining in engagement with the second section 715. It is to be noted that the inflation apparatuses illustrated and described herein can provide an outward radial force to a prosthetic heart valve. In aspects, this outward radial force can be applied to cause the prosthetic heart valve to radially expand, for example, as part of a postimplant diltatation procedure. Alternatively, this outward radial force can be applied to cause a fracture in a prosthetic heart valve, for example, as part of a bioprosthetic valve fracture procedure . When used as part of a bioprosthetic valve fracture procedure, the balloon that contacts the index valve to induce the fracture can comprise a non- compliant material, due to the relatively high stresses required to induce the fracture. Accordingly, the inflation apparatuses illustrated and described herein can be used in several applications related to providing outward radial force.

[0102] FIG. 12 illustrates an embodiment of the inflation apparatus 801 wherein the inflation apparatus 801 can comprise a filter 1201 that extends substantially perpendicular to the longitudinal axis 802, with the filter positioned within an interior region of the anchor 809 through which the catheter 827 extends. In aspects, the filter 1201 can comprise a mesh material, comprising a barrier of interlaced strands of metal, fiber, or the like. The filter 1201 can be attached to an inner side of the anchor tips 1007, 1009, etc. and / or inner surfaces of the anchor portions 1001, 1003, etc.. In this way, the filter 1201 can extend across the interior region of the anchor 809 substantially perpendicular to the longitudinal axis 802. The filter 1201 can limit material from passing through the filter 1201 while selectively allowing blood to pass through theopenings in the filter 1201. That is, the filter 1201 can allow blood to flow and pass through the gaps 1005 (e.g., between anchor portions 1001, 1003) while limiting debris from passing through the gaps 1005. For example, the openings in the filter 1201 are large enough to not impede the flow of blood through the filter 1201 and past the inflation apparatus 801. However, the openings in the filter 1201 may be small enough to prevent passage of unwanted materials (e.g., calcification deposits, debris, etc.) through the filter 1201. As such, the filter 1201 can function to catch these unwanted materials that are too large to pass through the openings in the filter 1201. In aspects, to further facilitate the capture of the unwanted materials, the filter 1201 can comprise a conical funnel shape that narrows in size along a direction of the blood flow.

[0103] FIG. 13 illustrates another example of an inflation apparatus 1301 for radially-expanding the heart valve prosthesis 10. The inflation apparatus 1301 is similar in some respects to the inflation apparatus 801 illustrated in FIGS. 8-12. For example, the inflation apparatus 1301 can comprise the first balloon 803 and the catheter 827, with the first balloon 803 configured to be positioned in the first section 713. However, the inflation apparatus 1301 can comprise an anchor 1303 that differs in structure from the anchor 809 of the inflation apparatus 801. For example, the anchor 1303 can comprise a toroidal or spiral shape that surrounds the catheter 827. The toroidal shape is a shape comprising a closed plane curve rotated about the axis 802 that lies in the same plane as the curve, without the axis 802 intersecting the anchor 1303 (e.g., a wall of the anchor 1303). The toroidal shape comprises an opening at a center through which the catheter 827 extends. The spiral shape is a shape that winds in a continuous and gradually widening curve, either around a central point on a flat plane or about an axis to form a cone.

[0104] In aspects, the anchor 1303 is hollow and can comprise a wall 1305 that is enclosed and defines an interior volume. The interior volume of the anchor 1303 is in fluid communication with the catheter 827, such that the catheter 827 can deliver a fluid to the anchor 1303. In this way, the anchor 1303 can function as a balloon, wherein the anchor 1303 can be pressurized from a deflated state to an inflated state (e.g., as illustrated in FIG. 13). In aspects, the anchor 1303 can comprise an inflation conduit 1307 (e.g., tube, hose, etc.) that is substantially hollow and attached to the anchor 1303 and the catheter 827. The inflation conduit 1307 is hollow such that the fluid can be delivered from the catheter 827, through the inflation conduit 1307, and to the anchor1303. When the anchor 1303 is in the inflated state, the anchor 1303 can radially- expand and contact the interior surface 903 of the second section 715 (e.g., illustrated in FIG. 11). The anchor 1303 can be in frictional contact with the interior surface 903 such that the frictional force between the anchor 1303 and the interior surface 903 can limit the anchor 1303 from moving (e.g., both rotationally about the axis 802 and axially along the axis 802).

[0105] In operation, the anchor 1303 can be pressurized to the inflated state prior to the pressurization of the first balloon 803. For example, in aspects, the catheter 827 is not limited to comprising a single chamber (e.g., the hollow chamber 829), but, rather, may comprise a plurality of hollow chambers that are not in fluid communication with one another. A second hollow chamber 1309 of the catheter 827 can be in fluid communication with the anchor 1303 while the hollow chamber 829 can be in fluid communication with the first balloon 803. In this way, the first balloon 803 and the anchor 1303 can be separately pressurized and inflated. For example, the catheter 827 can first deliver fluid to the anchor 1303 through the second hollow chamber 1309. Then, following the inflation of the anchor 1303 to the inflated position illustrated in FIG. 13, the catheter 827 can subsequently deliver fluid to the first balloon 803 through the hollow chamber 829 to pressurize the first balloon 803. In aspects, the anchor 1303 can comprise a filter 1313 that can be positioned within an interior region of the anchor 1303 through which the catheter 827 extends. The filter 1313 may be similar in structure to the filter 1201 of FIG. 12, and may comprise a mesh material that can limit unwanted materials from passing through the filter while allowing for blood to flow through the filter.

[0106] FIG. 14 illustrates another example of an inflation apparatus 1401 for radially-expanding the heart valve prosthesis 10. The inflation apparatus 1401 can comprise a first balloon 1403 configured to be attached to the catheter 827. The first balloon 1403 can be moved from a deflated state to an inflated state (e.g., illustrated in FIG. 14). As such, the first balloon 1403 can simultaneously contact the first section 713 and the second section 715 of the heart valve prosthesis 10.

[0107] The first balloon 1403 can comprise a first region 1405, a second region 1407, and a central region 1409 positioned between the first region 1405 and the second region 1407. The inflation apparatus 1401 can be moved, while in a deflated state, through a patient’s vasculature to the heart valve prosthesis 10 such that the first region1405 can be positioned within the first section 713 and the second region 1407 can be positioned within the second section 715. In the inflated state illustrated in FIG. 14, the first region 1405 can comprise a first balloon diameter 1415 such that the first region 1405 can be in contact with the interior surface 901 of the first section 713. The second region 1407 can be pressurized from a deflated state to the inflated state such that the second region 1407 can comprise a second balloon diameter 1417 in the inflated state. In this way, the second region 1407 can be in contact with the interior surface 903 of the second section 715. In aspects, the first balloon diameter 1415 may be different than the second balloon diameter 1417. For example, the first balloon diameter 1415 may be less than the second balloon diameter 1417. The balloon diameters 1415, 1417 can be selected based on the diameters of the first section 713 and the second section 715 of the heart valve prosthesis 10. In this way, the central region 1409 can comprise a reduced diameter that is less than the first balloon diameter 1415 and the second balloon diameter 1417 to accommodate for the reduced diameter of the waist section 717.

[0108] To accommodate for the range of annulus sizes, in aspects, the first balloon diameter 1415 can be within a range from about 17 millimeters to about 30 millimeters, or about 23 millimeters to about 27 millimeters, or within a range from about 24 millimeters to about 26 millimeters. The first region 1405 can comprise a length that is within a range from about 17 millimeters to about 23 millimeters, or about 20 millimeters. In aspects, the second balloon diameter 1417 can be within a range from about 30 millimeters to about 37 millimeters, or about 30 millimeters to about 35 millimeters, or about 33.5 millimeters. The second region 1407 can comprise a length that is within a range from about 17 millimeters to about 23 millimeters, or about 20 millimeters. In aspects, the central region 1409 can comprise a diameter that is less than about 25 millimeters. The central region 1409 can comprise a length that is within a range from about 25 millimeters to about 35 millimeters, or about 30 millimeters. In aspects, an end of the first region 1405 and an end of the second region 1407 can be tapered toward the catheter 827, with the taper length selectable to reduce stress (e.g., the taper of the second region 1407) and / or to reduce protrusion into a ventricle (e.g., the taper of the first region 1405). It will be appreciated that the aforementioned dimensions are merely exemplary, and that, based on the size of the heart valveprosthesis 10, the dimensions can be adjusted to be outside of the aforementioned ranges.

[0109] The first region 1405, the second region 1407, and the central region 1409 can be contiguous and in fluid communication with one another. For example, the first region 1405, the second region 1407, and the central region 1409 can define a single interior chamber that is pressurized by fluid from the catheter 827. In operation, the inflation apparatus 1401 can be pressurized, which can cause the first region 1405, the second region 1407, and the central region 1409 to move from a deflated state to the inflated state of FIG. 14. In the inflated state, the second region 1407 can be in frictional contact with the interior surface 903 of the second section 715 such that the frictional force between the second region 1407 and the interior surface 903 can limit the inflation apparatus 1401 from moving (e.g., both rotationally about the axis 802 and axially along the axis 802). In this way, the second region 1407 can simultaneously function to radially expand the second section 715 while stabilizing the inflation apparatus 1401 during inflation / pressurization. In the inflated state, the first region 1405 can contact the interior surface 901 of the first section 713 to facilitate radial expansion of the first section 713. In aspects, the first region 1405, the second region 1407, and the central region can comprise a compliant material or a semi-compliant material, such as, for example, a high durometer polyurethane material, a polyether block amide, or the like.

[0110] FIG. 15 illustrates another example of an inflation apparatus 1501 for radially-expanding the heart valve prosthesis 10. The inflation apparatus 1501 can be similar in some respects to the inflation apparatus 1401 of FIG. 14, for example, with the inflation apparatus 1401 comprising the first region 1405, the second region 1407, and the central region 1409. In aspects, the inflation apparatus 1501 can further comprise a collar 1503 comprising a non-compliant material that may be a different material than the first region 1405, for example, when the first region 1405 comprises a compliant material. The non-compliant material may comprise, for example, polyester or nylon. In aspects, the collar 1503 can be positioned to circumferentially surround at least a portion of the first region 1405. For example, the collar 1503 can comprise a balloon or other inflatable device that can be selectively radially-expanded.

[0111] The collar 1503 can define an interior volume that is separate from, and not in fluid communication with, the interior volume defined by the first region 1405, the second region 1407, and the central region 1409. In this way, the regions 1405, 1407,1409 can be pressurized and inflated separately from, and independently of, the pressurization and inflation of the collar 1503. For example, initially, the inflation apparatus 1501 can be in a deflated state when the inflation apparatus 1501 moves through a patient’s vasculature to the heart valve prosthesis 10. Upon reaching the heart valve prosthesis 10, the regions 1405, 1407, 1409 can be pressurized and inflated. For example, the catheter 827 can comprise the hollow chamber 829 and the second hollow chamber 1309. The hollow chamber 829 can be in fluid communication with the first balloon 1403 (e.g., the interior volume defined by the regions 1405, 1407, 1409), and the second hollow chamber 1309 can be in fluid communication with the collar 1503. As such, with the inflation apparatus 1501 positioned within the heart valve prosthesis 10, the first balloon 1403 (e.g., the interior volume defined by the regions 1405, 1407, 1409) can be pressurized / inflated first, for example, by delivering fluid through the hollow chamber 829 and into the interior volume defined by the regions 1405, 1407, 1409. In the inflated state, the second region 1407 can be in frictional contact with the interior surface 903 of the second section 715 such that the frictional force between the second region 1407 and the interior surface 903 can limit the inflation apparatus 1401 from moving (e.g., both rotationally about the axis 802 and axially along the axis 802). As such, the second region 1407 can simultaneously function to radially expand the second section 715 while stabilizing the inflation apparatus 1401 during inflation / pressurization.

[0112] The collar 1503, which has not yet been pressurized / inflated, can limit the first region 1405 from fully radially expanding, due to the collar 1503 circumferentially surrounding the first region 1405 and comprising the non-compliant material. Once the second region 1407 is in frictional engagement with the second section 715, such that the inflation apparatus 1501 has been anchored, the collar 1503 can be pressurized / inflated. For example, fluid can be delivered through the second hollow chamber 1309 and into the interior volume defined by the collar 1503. This pressurization / inflation of the collar 1503 can cause the collar 1503 to radially expand, while also allowing the first region 1405 to radially expand. As such, one or both of the first region 1405 and / or the collar 1503 can contact the interior surface 901 of the first section 713 to facilitate radial expansion of the first section 713.

[0113] FIG. 16 illustrates another example of an inflation apparatus 1601 for radially-expanding the heart valve prosthesis 10. The inflation apparatus 1601 can besimilar in some respects to the inflation apparatus 1401 of FIG. 14. For example, the inflation apparatus 1601 can comprise a first balloon 1603 comprising a first region 1605, a second region 1607, and a central region 1609. The first region 1605 is substantially identical to the first region 1405 in position, function, and material, but with the first region 1605 comprising a different shape. For example, the first region 1605 can comprise a spherical shape, with the first region 1605 configured to be positioned in the first section 713. The second region 1607 is substantially identical to the second region 1407 in position, function, and material, but with the second region 1407 comprising a different shape. For example, the second region 1607 can comprise a spherical shape, with the second region 1607 configured to be positioned in the second section 715. The central region 1609 is substantially identical to the central region 1409 in position, function, and material, but with the central region 1609 comprising a rounded, hourglass shape. The regions 1605, 1607, 1609 can be substantially identical in dimension to the regions 1405, 1407, 1409, with the first region 1605 comprising the first balloon diameter 1415, and the second region 1607 comprising the second balloon diameter 1417. The inflation apparatus 1601 can operate in a substantially identical manner as the inflation apparatus 1401, with the second region 1607 configured to anchor the inflation apparatus 1601 while the inflation apparatus 1601 radially expands the heart valve prosthesis 10.

[0114] FIG. 17 illustrates another example of an inflation apparatus 1701 for radially-expanding the heart valve prosthesis 10. The inflation apparatus 1701 can be similar in some respects to the inflation apparatus 801 of FIG. 8. For example, the inflation apparatus 1701 can comprise the first balloon 803 comprising the first balloon diameter 805. The first balloon 803 of the inflation apparatus 1701 is substantially identical in structure, function, and position to the first balloon 803 of the inflation apparatus 801.

[0115] The inflation apparatus 1701 can comprise a second balloon 1703 that is configured to be positioned in the second section 715. The second balloon 1703 can be pressurized from the deflated state to the inflated state (e.g., illustrated in FIG. 17), with the second balloon 1703 comprising a second balloon diameter in the inflated state. In this way, the second balloon 1703 is configured to be in contact with the interior surface 903 of the second section 715 (e.g., illustrated in FIG. 18) and prevent relative movement along the longitudinal axis 802 between the second balloon 1703 and theprosthetic heart valve 10. The second balloon 1703 can be similar to the first balloon 803 in shape (e.g., comprising tapered walls 811, 813 on opposing sides of a nontapered wall 815) and material, though with the second balloon 1703 comprising a second balloon diameter that may be different than the first balloon diameter 805.

[0116] In aspects, the first balloon 803 and the second balloon 1703 are spaced a distance apart, such that the first balloon 803 can comprise a first interior space 1711 that is separate from, and not in fluid communication with, a second interior space 1713 of the second balloon 1703. In this way, the first balloon 803 can be pressurized and inflated separately from the second balloon 1703. For example, the first balloon 803 and the second balloon 1703 can be attached to the catheter 827. The catheter 827 can extend through the waist section between the first balloon 803 and the second balloon 1703. In aspects, the catheter 827 can comprise a first hollow chamber 1717 in fluid communication with the first interior space 1711 of the first balloon 803. The catheter 827 can further comprise a second hollow chamber 1721 in fluid communication with the second interior space 1713 of the second balloon 1703. The first hollow chamber 1717 and the second hollow chamber 1721 can extend substantially coaxially with one another, with the second hollow chamber 1721 circumferentially surrounding the first hollow chamber 1717. In aspects, the catheter 827 can comprise a first wall 1715 that circumferentially surrounds, and defines, the first hollow chamber 1717. The catheter 827 can further comprise a second wall 1719 that circumferentially surrounds, and defines, the second hollow chamber 1721. In this way, the second wall 1719 is spaced apart from the first wall 1715, with the second wall 1719 comprising a larger diameter than the first wall 1715.

[0117] The first wall 1715 can extend through the second interior space 1713 of the second balloon 1703, with the second wall 1719 extending to, and in fluid communication with, the first balloon 803. Therefore, the first wall 1715 may define a closed volume with zero openings within the second interior space 1713 of the second balloon 1703, such that fluid may not flow through the first wall 1715 from the first hollow chamber 1717 and into the second interior space 1713. Rather, fluid may pass through the first hollow chamber 1717 toward the first balloon 803, whereupon the fluid may be delivered to the first interior space 1711. The second hollow chamber 1721 may be in fluid communication with the second interior space 1713. For example, the second wall 1719 can be attached to a wall of the second balloon 1703. In this way,fluid may pass through the second hollow chamber 1721 toward the second balloon 1703, whereupon the fluid may be delivered to the second interior space 1713. Accordingly, the catheter 827 can separately pressurize the first balloon 803 and the second balloon 1703.

[0118] FIG. 18 illustrates the inflation apparatus 1701 positioned in, and in engagement with, the heart valve prosthesis 10. Initially, the inflation apparatus 1701 can be in a deflated state when the inflation apparatus 1701 moves through a patient’s vasculature to the heart valve prosthesis 10. Upon reaching the heart valve prosthesis 10, the second balloon 1703 can be pressurized to radially-expand from the deflated state to the inflated state. To pressurize the second balloon 1703, a fluid can be delivered through the second hollow chamber 1721 to the second interior space 1713. In this way, the second balloon 1703 can radially-expand and contact the interior surface 903 of the second section 715. The second balloon 1703 can be in frictional contact with the interior surface 903 such that the frictional force between the second balloon 1703 and the interior surface 903 can limit the inflation apparatus 1701 from moving (e.g., both rotationally about the axis 802 and axially along the axis 802). Accordingly, the second balloon 1703 can be pressurized and inflated prior to pressurization / inflation of the first balloon 803. Following the pressurization / inflation ofthe second balloon 1703, fluid can be delivered through the first hollow chamber 1717 to the first interior space 1711 of the first balloon 803. This can cause the first balloon 803 to radially-expand and contact the interior surface 901 of the first section 713 to increase the diameter of the first section 713. As the first balloon 803 is pressurized and inflated, the inflation apparatus 1701 is limited from moving relative to the heart valve prosthesis 10 due to the second balloon 1703 remaining in engagement with the second section 715. It will be appreciated that FIGS. 17-18 illustrate one possible example of separate hollow chambers 1717, 1721 that can separately pressurize / inflate the balloons. Rather, in the alternative, the catheter 827 can comprise the two hollow chambers 829, 1309 illustrated in FIG. 13 that can separately and independently pressurize the balloons 803, 1703 of FIG. 17.

[0119] FIGS. 19-20 illustrate another example of an inflation apparatus 1901 for radially-expanding the heart valve prosthesis 10. The inflation apparatus 1901 can be similar in some respects to the inflation apparatus 1301 of FIG. 13. For example, the inflation apparatus 1901 can comprise the first balloon 803 comprising the first balloondiameter 805. In addition, the inflation apparatus 1301 can comprise an anchor 1903. The anchor 1903 can comprise a second balloon 1905 comprising atoroidal shape (e.g., hoop shape) that circumferentially surrounds the catheter 827. In contrast to the anchor 1303 illustrated in FIG. 13, which circumferentially surrounds the catheter 827 while not extending completely around the catheter 827, the second balloon 1905 can completely surround (e.g., 360 degrees) the catheter 827. The second balloon 1905 is hollow and can comprise a wall 1907 that is enclosed and defines an interior volume. The interior volume of the second balloon 1905 may be in fluid communication with an inflation conduit 1909. The inflation conduit 1909 may be located at an exterior of the catheter 827, for example, with the inflation conduit 1909 extending substantially parallel to the catheter 827. In this way, fluid can be delivered through the inflation conduit 1909 to the second balloon 1905.

[0120] Referring to FIG. 20, initially, the inflation apparatus 1901 can be in a deflated state as the inflation apparatus 1901 moves through a patient’s vasculature to the heart valve prosthesis 10. Upon reaching the heart valve prosthesis 10, the second balloon 1905 can be pressurized to radially-expand from the deflated state to the inflated state. To pressurize the second balloon 1905, a fluid can be delivered through the inflation conduit 1909 to the second balloon 1905. In this way, the second balloon 1905 can radially-expand and contact the interior surface 903 of the second section 715. The second balloon 1905 can be in frictional contact with the interior surface 903 such that the frictional force between the second balloon 1905 and the interior surface 903 can limit the inflation apparatus 1901 from moving (e.g., both rotationally about the axis 802 and axially along the axis 802). Accordingly, the second balloon 1905 can be pressurized and inflated prior to pressurization / inflation of the first balloon 803. With the second balloon 1905 in contact with the second section 715, the first balloon 803 can be pressurized and inflated, for example, by delivering fluid through the catheter 827 to the first balloon 803. This can cause the first balloon 803 to radially-expand and contact the interior surface 901 of the first section 713 to increase the diameter of the first section 713. As the first balloon 803 is pressurized and inflated, the inflation apparatus 1901 is limited from moving relative to the heart valve prosthesis 10 due to the second balloon 1905 remaining in engagement with the second section 715. While FIGS. 19-20 illustrate the inflation apparatus 1901 without a filter, the inflation apparatus 1901 is not so limited. Rather, in aspects, the inflation apparatus 1901 cancomprise the filter 1313 (e.g., illustrated in FIG. 13) positioned within the interior space defined by the second balloon 1905.

[0121] FIG. 21 illustrates another example of an anchor 2100 that can be used with the inflation apparatus 1901. For example, the anchor 2100 can comprise a spiral shape, for example, a three-dimensional curve that winds around an axis at a constant or continuously varying distance while moving parallel to the axis. In aspects, the anchor 2100 can comprise a balloon 2103 defining a substantially hollow interior or volume. In aspects, the inflation apparatus 1901 can comprise the anchor 1903 (e.g., illustrated in FIGS. 19-20) or may comprise the anchor 2100 illustrated in FIG. 21. The anchor 2100 can function in a substantially identical manner as the anchor 1903. The anchor 2100 can be attached to, and in fluid communication with, the inflation conduit 1909, or, alternatively, the anchor 2100 can be attached to, and in fluid communication with, the catheter 827 by the inflation conduit 1307. Therefore, the anchor 2100 can be inflated by receiving fluid from either of the inflation conduits 1307, 1909. In operation, the anchor 2100 can be pressurized to the inflated state prior to the pressurization of the first balloon 803. The anchor 2100 can be radially-expanded to contact the second section 715, whereby the anchor 2100 can limit the inflation apparatus 1901 from moving (e.g., both rotationally about the axis 802 and axially along the axis 802). In aspects, the anchors 1903, 2100 can comprise a compliant material, while the first balloon 803 can comprise a non-compliant material.

[0122] FIG. 22 illustrates another example of an inflation apparatus 2201 for radially-expanding the heart valve prosthesis 10. The inflation apparatus 2201 can comprise the first balloon 803 comprising the first balloon diameter 805. In addition, the inflation apparatus 2201 can comprise an anchor 2203. The anchor 2203 can comprise a second balloon 2205 comprising one or more segments, for example, a first segment 2207, a second segment 2209, a third segment 2211, and a fourth segment 2213. The segments 2207, 2209, 2211, 2213 may be attached to the catheter 827 and can extend radially outwardly from the catheter 827. The segments 2207, 2209, 2211, 2213 may be substantially hollow, such that the segments 2207, 2209, 2211, 2213 may be in fluid communication with the catheter 827, for example, the hollow chamber 829 of the catheter 827. In this way, the segments 2207, 2209, 2211, 2213 can be pressurized and inflated by the catheter 827, such that the segments 2207, 2209, 2211, 2213 can move from a deflated position to an inflated position (e.g., illustrated in FIGS.22-23). Though not required, in aspects, a filter can be attached to the segments 2207, 2209, 2211, 2213 to allow for blood to flow through the filter while preventing the passage of debris through the filter (e.g., similar to the filters of FIGS. 12-13).

[0123] In aspects, the first segment 2207 may be angled relative to the second segment 2209. For example, the first segment 2207 can extend along a first axis 2217, the second segment 2209 can extend along a second axis 2219, the third segment 2211 can extend along a third axis 2221, and the fourth segment 2213 can extend along a fourth axis 2223. The axes 2217, 2219, 2221, 2223 can extend perpendicular to the axis 802, for example, with the axes 2217, 2219, 2221, 2223 intersecting the axis 802. In aspects, the segments 2207, 2209, 2211, 2213 may be spaced circumferentially apart about the catheter 827, for example, with about 90 degrees separating each segment. In this way, the first segment 2207 may be substantially perpendicular to the second segment 2209, the second segment 2209 may be substantially perpendicular to the third segment 2211, the third segment 2211 may be substantially perpendicular to the fourth segment 2213, and the fourth segment 2213 may be substantially perpendicular to the first segment 2207. In aspects, the first axis 2217 and the third axis 2221 can be collinear, and the second axis 2219 and the fourth axis 2223 can be collinear. Accordingly, the second balloon 2205 can comprise a cross shape, with adjacent segments angled relative to one another. While FIGS. 22-23 illustrate the anchor 2203 as comprising four segments 2207, 2209, 2211, 2213, any number of segments (e.g., greater than or less than four segments) are possible. Further, the anchor 2203 is not limited to comprising a balloon. Rather, the segments 2207, 2209, 2211, 2213 can be formed of an expandable material, such as Nitinol, that can radially expand.

[0124] Referring to FIG. 23, initially, the inflation apparatus 2201 can be in a deflated state as the inflation apparatus 2201 moves through a patient’s vasculature to the heart valve prosthesis 10. Upon reaching the heart valve prosthesis 10, the second balloon 2205 can be pressurized to radially-expand from the deflated state to the inflated state. In aspects, the second balloon 2205 can be pressurized and inflated prior to pressurizing / inflating the first balloon 803, or, alternatively, the second balloon 2205 and the first balloon 803 can be pressurized / inflated at the same time. To pressurize / inflate the balloons 803, 2205 separately (e.g., with the second balloon 2205 being pressurized / inflated first), the catheter 827 may comprise the two separate hollow chambers 829, 1309, with one hollow chamber (e.g., 1309) in fluid communication withthe second balloon 2205, and the other hollow chamber (e.g., 829) in fluid communication with the first balloon 803. Alternatively, to pressurize / inflate the balloons 803, 2205 at the same time, the catheter 827 may comprise a single hollow chamber (e.g., 829) that is in fluid communication with both the first balloon 803 and the second balloon 2205.

[0125] To pressurize the second balloon 2205, a fluid can be delivered through the catheter 827 to the second balloon 2205. In this way, the second balloon 2205 can radially-expand, and the segments 2207, 2209, 2211, 2213 can contact the interior surface 903. For example, the ends of the segments 2207, 2209, 2211, 2213 can contact the interior surface 903 to frictionally engage the second section 715. The second balloon 2205 can therefore be in frictional contact with the interior surface 903 such that the frictional force between the second balloon 2205 and the interior surface 903 can limit the inflation apparatus 2201 from moving (e.g., both rotationally about the axis 802 and axially along the axis 802). Accordingly, the second balloon 2205 can be pressurized and inflated prior to pressurization / inflation of the first balloon 803. With the second balloon 2205 in contact with the second section 715, the first balloon 803 can be pressurized and inflated, for example, by delivering fluid through the catheter 827 to the first balloon 803. This can cause the first balloon 803 to radially-expand and contact the interior surface 901 of the first section 713 to increase the diameter of the first section 713. As the first balloon 803 is pressurized and inflated, the inflation apparatus 2201 is limited from moving relative to the heart valve prosthesis 10 due to the second balloon 2205 remaining in engagement with the second section 715.

[0126] FIG. 24 illustrates another example of an inflation apparatus 2501 for radially-expanding the heart valve prosthesis 10. The inflation apparatus 2501 can comprise a first balloon 2503 and a second balloon 2505. In aspects, the first balloon 2503 and the second balloon 2505 can comprise a spherical shape. However, other possible shapes are envisioned, such that the first balloon 2503 and the second balloon 2505 are not limited to the illustrated spherical shapes. For example, in aspects, the first balloon 2503 can comprise the tapered shape of the first balloon 803 illustrated in FIG. 17, and / or the second balloon 2505 can comprise the tapered shape of the second balloon 1703 illustrated in FIG. 17. Similar to the inflation apparatuses described herein, the first balloon 2503 and the second balloon 2505 can be attached to, and in fluid communication with, the catheter 827, such that the catheter 827 can deliver afluid to the first balloon 2503 and the second balloon 2505 to pressurize and inflate the inflation apparatus 2501.

[0127] In aspects, the inflation apparatus 2501 can comprise a hypotube 2507 attached to, and extending between, the first balloon 2503 and the second balloon 2505. In this way, the hypotube 2507 can be positioned in the waist section 717 of the heart valve prosthesis 10. The hypotube 2507 is configured to limit over-expansion of the inflation apparatus 2501, which reduces the application of pressure from the inflation apparatus 2501 to the waist section 717. In aspects, the hypotube 2507 can comprise a material that is limited from radially expanding beyond a predetermined diameter. For example, the hypotube 2507 can comprise Nitinol, stainless steel, or other suitable metals. FIG. 24 illustrates the hypotube 2507 as a maximum radial expansion. In this way, the hypotube 2507 may not contact the waist section 717 while the first balloon 2503 contacts the first section 713 and the second balloon 2505 contacts the second section 715. As with the previous examples, the catheter 827 can comprise a single hollow chamber (e.g., 829) to pressurize / inflate the balloons 2503, 2505 at the same time, or multiple hollow chambers (e.g., 829, 1309, 1717, 1721) to pressurize / inflate the balloons 2503, 2505 separately and independently.

[0128] FIG. 25 illustrates another example of an inflation apparatus 2601 for radially-expanding the heart valve prosthesis 10. The inflation apparatus 2601 can comprise a first balloon 2603 and a second balloon 2605. The first balloon 2603 and the second balloon 2605 may be in fluid communication with one another, such that the first balloon 2603 and the second balloon 2605 can be simultaneously pressurized / inflated. In aspects, the first balloon 2603 and / or the second balloon 2605 can comprise a conical shape, for example, a bicone shape. A bicone shape is a three- dimensional shape in which two cones are joined together at their bases.

[0129] With reference to the first balloon 2603, the first balloon 2603 can comprise a first wall 2607 and a second wall 2609. The first wall 2607 and the second wall 2609 are joined together at a first edge 2611, which may be located at a midpoint along a length of the first balloon 2603. In aspects, the first wall 2607 can comprise a conical shape that is tapered with a decreasing diameter in a direction away from the first edge 2611. Likewise, the second wall 2609 can comprise a conical shape that is tapered with a decreasing diameter in a direction away from the first edge 2611. In this way, thefirst edge 2611 can define the maximum diameter of the first balloon 2603, with the first edge 2611 in contact with the interior surface 901 of the first section 713.

[0130] With reference to the second balloon 2605, the second balloon 2605 can comprise a first wall 2615 and a second wall 2617. The first wall 2615 and the second wall 2617 are joined together at a second edge 2619, which may be located at a midpoint along a length of the second balloon 2605. In aspects, the first wall 2615 can comprise a conical shape that is tapered with a decreasing diameter in a direction away from the second edge 2619. Likewise, the second wall 2617 can comprise a conical shape that is tapered with a decreasing diameter in a direction away from the second edge 2619. In this way, the second edge 2619 can define the maximum diameter of the second balloon 2605, with the second edge 2619 in contact with the interior surface 903 of the second section 715.

[0131] In operation, the inflation apparatus 2601 may initially be in a deflated state as the inflation apparatus 2601 moves through a patient’s vasculature to the heart valve prosthesis 10. Upon reaching the heart valve prosthesis 10, the first balloon 2603 and the second balloon 2605 can be simultaneously pressurized and inflated. For example, a fluid can be delivered through the catheter to interior spaces of the first balloon 2603 and the second balloon 2605. In this way, the first balloon 2603 and the second balloon 2605 can radially-expand. In aspects, the second balloon 2605 can radially-expand and contact the interior surface 903 to frictionally engage the second section 715. The second balloon 2605 can therefore be in frictional contact with the interior surface 903 such that the frictional force between the second balloon 2605 and the interior surface 903 can limit the inflation apparatus 2601 from moving (e.g., both rotationally about the axis 802 and axially along the axis 802). Likewise, the first balloon 2603 can be inflated, causing the first balloon 2603 to radially-expand and contact the interior surface 901, thus increasing the diameter of the first section 713. As with the previous examples, the catheter 827 can comprise a single hollow chamber (e.g., 829) to pressurize / inflate the balloons 2603, 2605 at the same time, or multiple hollow chambers (e.g., 829, 1309, 1717, 1721) to pressurize / inflate the balloons 2603, 2605 separately and independently. In aspects, the hypotube 2507 (e.g., illustrated in FIG. 25) can be used to maintain the waist section.

[0132] FIGS. 26-27 illustrate another example of an inflation apparatus 2801 for radially-expanding the heart valve prosthesis 10. Referring first to FIG. 26, initially, asthe inflation apparatus 2801 is delivered to the heart valve prosthesis 10, the inflation apparatus 2801 can be in a deflated state and housed within a sheath 2701. The sheath 2701 can define a recess or channel that is sized to receive the deflated inflation apparatus 2801. The sheath 2701 may be movable relative to the catheter 827, for example, by being retractable in a retraction direction 2703 relative to the catheter 827. As illustrated in FIG. 26, the inflation apparatus 2801 may be in a deflated state as the inflation apparatus 2801 moves through a patient’s vasculature to the heart valve prosthesis 10.

[0133] Referring to FIG. 26, reaching the heart valve prosthesis 10, the sheath 2701 can be retracted, for example, by being moved in the retraction direction 2703 relative to the catheter 827. Retraction of the sheath 2701 can allow for the inflation apparatus 2801 to be released from the interior of the sheath 2701. The inflation apparatus 2801 can then be pressurized / inflated by delivering a fluid from the catheter 827 to the first balloon 803 of the inflation apparatus 2801. While FIG. 27 illustrates the inflation apparatus 2801 as comprising the first balloon 803, the inflation apparatus 2801 can alternatively comprise any of the balloon shapes / designs described herein. The fluid can inflate and pressurize the first balloon 803, causing the first balloon 803 to contact and radially-expand the first section 713.

[0134] FIGS. 28-29 illustrate another example of an inflation apparatus 2901 for radially-expanding the heart valve prosthesis 10, wherein the inflation apparatus 2901 comprises the first balloon 803. Referring first to FIG. 28, the first balloon 803 can comprise one or more passageways extending through the first balloon 803 substantially parallel to the axis 802. For example, the first balloon 803 can comprise a first passageway 2903, a second passageway 2905, and a third passageway 2907. The passageways 2903, 2905, 2907 are illustrated as comprising circular shapes, but other shapes are possible. Further, while the passageways 2903, 2905, 2907 are illustrated as passing through the first balloon 803, other balloons described herein, whether configured to contact first section 713 or second section 715, could similarly comprise one or more of the passageways 2903, 2905, 2907. The passageways 2903, 2905, 2907 are oriented parallel to a direction of blood flow, such that the passageways 2903, 2905, 2907 can allow for blood to flow through the first balloon 803 while the first balloon 803 is in the inflated state.

[0135] FIG. 29 illustrates the inflation apparatus 2901 positioned within the first section 713. In this way, the first balloon 803 can be pressurized / inflated to move from a deflated state to the inflated state, thus facilitating radial expansion of the first section 713. As the first balloon 803 is in contact with the first section 713, blood can flow through the passageways 2903, 2905, 2907, thus reducing interference with blood flow by the first balloon 803. In aspects, the first balloon 803 can comprise a non-compliant material, such that the first balloon 803 can alternatively perform the functions of radial expansion of the heart valve prosthesis 10 and / or bioprosthetic valve fracture of an existing prosthetic valve.

[0136] FIG. 30 is a sectional illustration of another example of the first balloon 803, wherein the first balloon 803 can comprise a plurality of walls. For example, the first balloon 803 can comprise a first wall 3101 and a second wall 3103. The first wall 3101 and the second wall 3103 can be attached to, and in fluid communication with, the catheter 827. In aspect, the first wall 3101 may be circumferentially surrounded by the second wall 3103 such that the second wall 3103 is located radially exterior of the first wall 3101. In aspects, the first wall 3101 can define and surround a first enclosed volume 3105. The second wall 3103 can define and surround a second enclosed volume 3107, wherein the second enclosed volume 3107 is between the first wall 3101 and the second wall 3103. In aspects, the first wall 3101 may comprise a semi -compliant material, which may allow for radial expansion of the heart valve prosthesis 10. In aspects, the second wall 3103 may comprise a non-compliant material, such that the second wall 3103 may comprise a different material than the first wall. The first wall 3101 and the second wall 3103 may be attached to one another at opposing longitudinal ends.

[0137] In operation, a fluid can be delivered through the catheter 827 to the first balloon 803. The fluid can flow into the first enclosed volume 3105 but will not flow into the second enclosed volume 3107. As the first enclosed volume 3105 receives the fluid, the first enclosed volume 3105 can be pressurized and inflated, thus causing the first wall 3101 to radially expand. This radial expansion can allow for the first balloon 803 to contact an interior surface of the heart valve prosthesis 10, thus facilitating radial-expansion of the heart valve prosthesis 10. Due to the second wall 3103 comprising the non-compliant material, the second wall 3103 can limit the maximum radial expansion of the first wall 3101. For example, once a nominal pressure has beenreached within the first enclosed volume 3105 and the first wall 3101 has radially- expanded, the second wall 3103 can contact and constrain the first wall 3101, thus limiting further radial expansion of the first wall 3101. In aspects, the first balloon 803 is not limited to being used to radially-expand the heart valve prosthesis 10. Rather, the first balloon 803 can be used as part of a bioprosthetic valve fracture process. For example, the first balloon 803 can be pressurized / inflated, and due to the second wall 3103 comprising the non-compliant material, the second wall 3103 may exert a pressure on an existing prosthetic valve to cause a fracture.

[0138] FIG. 31-32 illustrate another example of an inflation apparatus 3201 for radially-expanding the heart valve prosthesis 10, wherein the inflation apparatus 3201 comprises the first balloon 1403 (e.g., also illustrated in FIG. 14). In aspects, the first balloon 1403 can comprise a reinforcement wall 3301 that can provide structural support to at least a portion of the inflation apparatus 3201. For example, FIG. 32 illustrates a sectional view of the first balloon 1403 along lines 32-32 of FIG. 31. As illustrated, the first balloon 1403 can comprise an exterior wall 3202 and the reinforcement wall 3301. The exterior wall 3202 can circumferentially surround the reinforcement wall 3301, such that the reinforcement wall 3301 can be within an interior of the exterior wall 3202. In aspects, less than all of the first balloon 1403 may comprise the reinforcement wall 3301. For example, the first region 1405 (e.g., which can be positioned in the first section 713) can comprise the reinforcement wall 3301, while the second region 1407 and the central region 1409 may not comprise the reinforcement wall 3301. The reinforcement wall 3301 can be in the form of a cage, surface reinforcement, fiber matrix, or the like. The exterior wall 3202 can comprise a compliant material that can be inflated, as described relative to FIG. 14. The first balloon 1403 can perform the function of radially expanding the heart valve prosthesis 10, while also being able to exert a pressure on an existing prosthetic valve to cause a fracture (e.g., bioprosthetic valve fracture). The reinforcement wall 3301 can provide additional structural support to the first balloon 1403 to facilitate bioprosthetic valve fracture. It will be appreciated that while FIGS. 31-32 illustrate the first balloon 1403 as comprising the reinforcement wall 3301, any of the other balloons described herein could likewise comprise the reinforcement wall 3301.

[0139] In aspects, and as described herein, methods of applying an outward radial force to a heart valve prosthesis positioned at a treatment site within a patient areprovided. The heart valve prosthesis can comprise the first section (e.g., 713) at the inflow end of the heart valve prosthesis, the second section (e.g., 715) at the outflow end of the heart valve prosthesis, and the waist section positioned between the first section and the second section. The heart valve prosthesis is positioned such that the first section is within an annulus at the treatment site. Methods can comprise positioning the inflation apparatus within a central lumen of the heart valve prosthesis. The inflation apparatus can comprise a first balloon positioned in the first section. In some aspects, the first balloon may be positioned to contact or expand only a portion of the first section (e.g., inflow end). For example, the first balloon may be configured to expand only the proximal-most crowns of the prosthesis frame (e.g., stent crowns at the free end of the frame at the inflow end, also referred to as node 0). In another example, as shown in FIG. 11, the first balloon may be positioned to contact or expand only the proximal-most crowns and the first node (node 1), where struts from adjacent crowns are joined. In a further example, the first balloon may be positioned to contact or expand only the proximal-most crowns, the first node, and the second node (e.g., the connection forming the top of the diamond cells at the inflow end). Methods can comprise anchoring a portion of the inflation apparatus to contact an interior surface of the heart valve prosthesis to prevent relative movement along a longitudinal axis between the inflation apparatus and the heart valve prosthesis. Methods can comprise inflating the first balloon such that the first balloon contacts an interior of the first section to increase a diameter of the first section. In aspects, the anchoring comprises radially expanding a portion of the inflation apparatus to contact the second section such that the inflation apparatus is in frictional engagement with the second section. In some aspects, the anchor or balloon may be positioned to contact or engage only a portion of the second section (e.g., the outflow end). For example, the anchor / balloon may be configured to contact or engage only the distal-most portion of the prosthesis frame, such as the distal-most cell of the frame (cell at the free end of the frame at the outflow end). In another example, the anchor / balloon may be configured to contact or engage the distal -most cell of the frame and / or a second-most distal cell of the frame. In aspects, the anchoring occurs prior to the inflating of the first balloon. In aspects, the anchoring can comprise inflating a second balloon that contacts the second section. In aspects, neither the inflow balloon nor the outflow anchor / balloon may contact the waist portion of the prosthesis and / or the portion of the prosthesis having thereplacement valve and valve leaflets. In one aspect, avoiding contact with the valve and valve leaflets may avoid damage or rearrangement of the valve. For example, the inflow balloon may contact below the annulus and / or margin of attachment of the valve and the outflow anchor / balloon may contact above the commissure attachment points (e.g., posts or pads).

[0140] It should be understood that while various aspects have been described in detail relative to certain illustrative and specific examples thereof, the present disclosure should not be considered limited to such, as numerous modifications and combinations of the disclosed features are possible without departing from the scope of the following claims. For example, numerous balloons have been described for contacting / expanding the first section of the prosthesis and numerous anchors / balloons have been described for contacting / frictionally engaging the second section of the prosthesis. It should be understood that while not every combination of balloons for the first section and balloons / anchors for the second section have been shown, any combination of first section and second section balloon / anchor is contemplated herein.

[0141] The following examples are illustrative of the techniques described herein.

[0142] Example 1. An inflation apparatus for applying an outward radial force to a prosthetic heart valve comprising an annular frame extending along a longitudinal axis between an inflow end and an outflow end, the frame comprising a plurality of struts and configured to be adjustable between a radially-collapsed position and a radially-expanded position, the frame comprising a first section at the inflow end, a second section at the outflow end, a waist section positioned between the first section and the second section, and a valve prosthesis comprising at least one leaflet attached to the plurality of struts; the inflation apparatus comprising: a first balloon configured to be positioned in the first section, the first balloon configured to be pressurized from a deflated state to an inflated state, the first balloon comprising a first balloon diameter in the inflated state such that the first balloon is configured to be in contact with an interior surface of the first section; an anchor configured to be positioned in the second section, the anchor movable between a first anchor diameter when the anchor is in a contracted state, and a second anchor diameter when the anchor is in an expanded state, the first anchor diameter less than the second anchor diameter, wherein the anchor contacts an interior surface of the second section when the anchor is in the expandedstate and prevents relative movement along the longitudinal axis between the anchor and the prosthetic heart valve; and a catheter configured to extend through the waist section between the first balloon and the anchor, the catheter comprising a hollow chamber in fluid communication with the first balloon.

[0143] Example 2. The inflation apparatus of claim 1, further comprising a filter extending substantially perpendicular to the longitudinal axis, the filter positioned within an interior region of the anchor through which the catheter extends.

[0144] Example 3. The inflation apparatus of claim 1, wherein the anchor comprises a first anchor length and the first anchor diameter when the anchor is in a contracted state, and a second anchor length and the second anchor diameter when the anchor is in an expanded state, the first anchor length greater than the second anchor length.

[0145] Example 4. The inflation apparatus of claim 3, wherein the anchor extends between a first longitudinal end and a second longitudinal end, the first longitudinal end attached to the catheter in a fixed axial position relative to the catheter, the second longitudinal end configured to move relative to the catheter to move the anchor between the expanded state and the contracted state.

[0146] Example 5. The inflation apparatus of claim 4, wherein the anchor comprises a first anchor portion and a second anchor portion spaced apart and extending between the first longitudinal end and the second longitudinal end, and wherein a gap is defined between the first anchor portion and the second anchor portion.

[0147] Example 6. An inflation apparatus for applying an outward radial force to a prosthetic heart valve comprising an annular frame extending along a longitudinal axis between an inflow end and an outflow end, the frame comprising a plurality of struts and configured to be adjustable between a radially-collapsed position and a radially-expanded position, the frame comprising a first section at the inflow end, a second section at the outflow end, a waist section positioned between the first section and the second section, and a valve prosthesis comprising at least one leaflet attached to the plurality of struts; the inflation apparatus comprising: a first balloon configured to be positioned in the first section, the first balloon configured to be pressurized from a deflated state to an inflated state, the first balloon comprising a first balloon diameter in the inflated state such that the first balloon is configured to be in contact with an interior surface of the first section; a second balloon configured to be positioned in thesecond section, the second balloon configured to be pressurized from a deflated state to an inflated state, the second balloon comprising a second balloon diameter in the inflated state such that the second balloon is configured to be in contact with an interior surface of the second section and prevent relative movement along the longitudinal axis between the second balloon and the prosthetic heart valve; and a catheter configured to extend through the waist section between the first balloon and the second balloon, the catheter comprising a first hollow chamber in fluid communication with the first balloon and a second hollow chamber in fluid communication with the second balloon.

[0148] Example 7. The inflation apparatus of claim 6, wherein the first balloon and the second balloon are spaced a distance apart such that the first balloon defines a first interior space that is separate from a second interior space of the second balloon, and wherein the catheter attaches the first balloon to the second balloon.

[0149] Example 8. The inflation apparatus of claim 6, wherein the second hollow chamber of the catheter circumferentially surrounds the first hollow chamber of the catheter.

[0150] Example 9. The inflation apparatus of claim 6, wherein one or more of the first balloon or the second balloon comprises one of a toroidal shape, a spiral shape, a spherical shape, a conical shape, or a cross shape comprising a first segment that is angled relative to a second segment.

[0151] Example 10. The inflation apparatus of claim 9, further comprising a filter extending substantially perpendicular to the longitudinal axis, the filter attached to the second balloon.

[0152] Example 11. An inflation apparatus for applying an outward radial force to a prosthetic heart valve comprising an annular frame extending along a longitudinal axis between an inflow end and an outflow end, the frame comprising a plurality of struts and configured to be adjustable between a radially-collapsed position and a radially-expanded position, the frame comprising a first section at the inflow end, a second section at the outflow end, a waist section positioned between the first section and the second section, and a valve prosthesis comprising at least one leaflet attached to the plurality of struts; the inflation apparatus comprising: a first balloon configured to be positioned in the first section, the first balloon configured to be pressurized from a deflated state to an inflated state, the first balloon comprising a first balloon diameter in the inflated state such that the first balloon is configured to be in contact with aninterior surface of the first section; and a catheter attached to the first balloon and comprising a first hollow chamber in fluid communication with the first balloon.

[0153] Example 12. The inflation apparatus of claim 11, wherein the first balloon comprises a first wall that defines a first enclosed volume, and a second wall that surrounds the first wall and defines a second enclosed volume between the first wall and the first wall, the first enclosed volume separated from the second enclosed volume.

[0154] Example 13. The inflation apparatus of claim 11, wherein the first balloon comprises one or more passageways extending through the first balloon substantially parallel to the longitudinal axis.

[0155] Example 14. The inflation apparatus of claim 11, wherein the first balloon comprises a first region and a second region along the longitudinal axis, the first region comprising a reinforcement material and the second region comprising a compliant material.

[0156] Example 15. The inflation apparatus of claim 11, wherein the first balloon comprises: a first region comprising the first balloon diameter such that the first region is configured to be in contact with the interior surface of the first section; and a second region configured to be positioned in the second section, the second region configured to be pressurized from a deflated state to an inflated state, the second region comprising a second balloon diameter in the inflated state such that the second region is configured to be in contact with an interior surface of the second section, and wherein the first region and the second region are contiguous and in fluid communication.

[0157] Example 16. The inflation apparatus of claim 15, further comprising a collar that circumferentially surrounds the first region, the collar comprising a non- compliant material that is different than the first region comprising a compliant material.

[0158] Example 17. A method of applying an outward radial force to a heart valve prosthesis positioned at a treatment site within a patient, the heart valve prosthesis comprising a first section at an inflow end of the heart valve prosthesis, a second section at an outflow end of the heart valve prosthesis, and a waist section positioned between the first section and the second section, the heart valve prosthesis positioned such that the first section is within an annulus at the treatment site; the method comprising: positioning an inflation apparatus within a central lumen of the heart valve prosthesis,the inflation apparatus comprising a first balloon positioned in the first section; anchoring a portion of the inflation apparatus to contact an interior surface of the heart valve prosthesis to prevent relative movement along a longitudinal axis between the inflation apparatus and the heart valve prosthesis; and inflating the first balloon such that the first balloon contacts an interior of the first section to increase a diameter of the first section.

[0159] Example 18. The method of claim 17, wherein the anchoring comprises radially expanding a portion of the inflation apparatus to contact the second section such that the inflation apparatus is in frictional engagement with the second section.

[0160] Example 19. The method of claim 18, wherein the anchoring occurs prior to the inflating of the first balloon.

[0161] Example 20. The method of claim 19, wherein the anchoring comprises inflating a second balloon that contacts the second section.

Claims

What is claimed is:

1. An inflation apparatus for applying an outward radial force to a prosthetic heart valve comprising an annular frame extending along a longitudinal axis between an inflow end and an outflow end, the frame comprising a plurality of struts and configured to be adjustable between a radially-collapsed position and a radially- expanded position, the frame comprising a first section at the inflow end, a second section at the outflow end, a waist section positioned between the first section and the second section, and a valve prosthesis comprising at least one leaflet attached to the plurality of struts; the inflation apparatus comprising: a first balloon configured to be positioned in the first section, the first balloon configured to be pressurized from a deflated state to an inflated state, the first balloon comprising a first balloon diameter in the inflated state such that the first balloon is configured to be in contact with an interior surface of the first section; an anchor configured to be positioned in the second section, the anchor movable between a first anchor diameter when the anchor is in a contracted state, and a second anchor diameter when the anchor is in an expanded state, the first anchor diameter less than the second anchor diameter, wherein the anchor contacts an interior surface of the second section when the anchor is in the expanded state and prevents relative movement along the longitudinal axis between the anchor and the prosthetic heart valve; and a catheter configured to extend through the waist section between the first balloon and the anchor, the catheter comprising a hollow chamber in fluid communication with the first balloon.

2. The inflation apparatus of claim 1, further comprising a filter extending substantially perpendicular to the longitudinal axis, the filter positioned within an interior region of the anchor through which the catheter extends.

3. The inflation apparatus of claim 1, wherein the anchor comprises a first anchor length and the first anchor diameter when the anchor is in a contracted state, and asecond anchor length and the second anchor diameter when the anchor is in an expanded state, the first anchor length greater than the second anchor length.

4. The inflation apparatus of claim 3, wherein the anchor extends between a first longitudinal end and a second longitudinal end, the first longitudinal end attached to the catheter in a fixed axial position relative to the catheter, the second longitudinal end configured to move relative to the catheter to move the anchor between the expanded state and the contracted state.

5. The inflation apparatus of claim 4, wherein the anchor comprises a first anchor portion and a second anchor portion spaced apart and extending between the first longitudinal end and the second longitudinal end, and wherein a gap is defined between the first anchor portion and the second anchor portion.

6. A method of applying an outward radial force to a heart valve prosthesis positioned at a treatment site within a patient, the heart valve prosthesis comprising a first section at an inflow end of the heart valve prosthesis, a second section at an outflow end of the heart valve prosthesis, and a waist section positioned between the first section and the second section, the heart valve prosthesis positioned such that the first section is within an annulus at the treatment site; the method comprising: positioning an inflation apparatus within a central lumen of the heart valve prosthesis, the inflation apparatus comprising a first balloon positioned in the first section; anchoring a portion of the inflation apparatus to contact an interior surface of the heart valve prosthesis to prevent relative movement along a longitudinal axis between the inflation apparatus and the heart valve prosthesis; and inflating the first balloon such that the first balloon contacts an interior of the first section to increase a diameter of the first section.

7. The method of claim 6, wherein the anchoring comprises radially expanding a portion of the inflation apparatus to contact the second section such that the inflation apparatus is in frictional engagement with the second section.

8. The method of claim 7, wherein the anchoring occurs prior to the inflating of the first balloon.

9. The method of claim 8, wherein the anchoring comprises inflating a second balloon that contacts the second section.

Images