Prosthetic heart valve apparatus

Abstract

A transcatheter valve apparatus includes a valve prosthesis including a plurality of prosthetic leaflets attached to a frame. The transcatheter valve apparatus includes an attachment structure positioned within the valve prosthesis. The attachment structure is attached to a first leaflet of the plurality of prosthetic leaflets and attached to a second leaflet of the plurality of prosthetic leaflets. The attachment structure maintains the first leaflet in a fixed position relative to the second leaflet such that the plurality of prosthetic leaflets are offset from a first ostia and a second ostia. The transcatheter valve apparatus includes a second valve prosthesis including a plurality of second prosthetic leaflets attached to a second frame. The second valve prosthesis is positioned within the valve prosthesis radially inward from the attachment structure. Method of providing access to one or more ostia are provided.

Description

PROSTHETIC HEART VALVE APPARATUSFIELD

[0001] The present disclosure relates generally to a prosthetic heart valve apparatus and, more particularly, to securing leaflets to avoid obstruction of the coronary arteries.BACKGROUND

[0002] It is known to provide a prosthetic heart valve apparatus 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, avoiding obstruction of the coronary arteries can be difficult.SUMMARY

[0003] The following presents a simplified summary of the disclosure to provide a basic understanding of some aspects described in the detailed description.

[0004] In aspects, a transcatheter valve apparatus comprises a valve prosthesis comprising a plurality of prosthetic leaflets attached to a frame. The transcatheter valve apparatus comprises an attachment structure positioned within the valve prosthesis, the attachment structure attached to a first leaflet of the plurality of prosthetic leaflets and attached to a second leaflet of the plurality of prosthetic leaflets. The attachment structure is configured to maintain the first leaflet in a fixed position relative to the second leaflet such that the plurality of prosthetic leaflets are offset from a first ostia and a second ostia. The transcatheter valve apparatus comprises a second valve prosthesis comprising a plurality of second prosthetic leaflets attached to a second frame. The second valve prosthesis is positioned within the valve prosthesis and radially inward from the attachment structure.

[0005] In aspects, the attachment structure is configured to move between a first position, in which a first attachment portion of the attachment structure is spaced a first distance from a second attachment portion of the attachment structure such that an attachment opening is defined between the first attachment portion and the secondattachment portion, and a second position, in which the first leaflet and the second leaflet are positioned within the attachment opening and the first attachment portion is spaced a second distance, which is less than the first distance, from the second attachment portion.

[0006] In aspects, the first attachment portion and the second attachment portion apply a compressive force to the first leaflet and the second leaflet when the first attachment portion and the second attachment portion are in the second position.

[0007] In aspects, the attachment structure comprises a nitinol material.

[0008] In aspects, the attachment structure is biased toward the second position.

[0009] In aspects, a wire extends between the first attachment portion and the second attachment portion.

[0010] In aspects, the attachment structure passes through a first leaflet opening in the first leaflet and a second leaflet opening in the second leaflet.

[0011] In aspects, a transcatheter valve apparatus comprises a delivery assembly configured to deliver a valve prosthesis to a treatment site. The delivery assembly comprises a capsule and a placement structure comprising a first flexible arm and a second flexible arm. The first flexible arm and the second flexible arm configured to move between a first position, in which the first flexible arm and the second flexible arm are outside of the capsule and a first separating distance separates the first flexible arm from the second flexible arm, and a second position, in which the first flexible arm and the second flexible arm are retracted into the capsule and a second separating distance separates the first flexible arm from the second flexible arm. The second separating distance is less than the first separating distance. An attachment structure is removably attached to the placement structure. The attachment structure comprises a first attachment portion removably attached to the first flexible arm. The attachment structure comprises a second attachment portion removably attached to the second flexible arm. The first attachment portion is configured to be detached from the first flexible arm and the second attachment portion is configured to be detached from the second flexible arm such that the first attachment portion is in contact with a first leaflet portion of a first leaflet, and the second attachment portion is in contact with a second leaflet portion of a second leaflet. The first attachment portion and the second attachment portion maintain the first leafletportion in a fixed position relative to the second leaflet portion such that the first leaflet portion and the second leaflet portion are offset from a first ostia and a second ostia.

[0012] In aspects, the first leaflet and the second leaflet comprise native leaflets of the native heart valve.

[0013] In aspects, the first leaflet and the second leaflet comprise prosthetic leaflets of a valve prosthesis.

[0014] In aspects, the attachment structure is configured to move between a first position, in which the first attachment portion is spaced a first distance from the second attachment portion such that an attachment opening is defined between the first attachment portion and the second attachment portion, and a second position, in which the first leaflet portion and the second leaflet portion are positioned within the attachment opening and the first attachment portion is spaced a second distance, which is less than the first distance, from the second attachment portion.

[0015] In aspects, the first attachment portion and the second attachment portion apply a compressive force to the first leaflet portion and the second leaflet portion when the first attachment portion and the second attachment portion are in the second position.

[0016] In aspects, the attachment structure comprises a nitinol material.

[0017] In aspects, the attachment structure comprises a wire extending between the first attachment portion and the second attachment portion.

[0018] In aspects, the attachment structure comprises an extension portion that extends outwardly from the first attachment portion and passes through a first leaflet opening in the first leaflet portion and a second leaflet opening in the second leaflet portion.

[0019] In aspects, methods of providing access to one or more ostia comprise positioning a distal end of a delivery assembly at a treatment site. Methods comprise deploying, from the delivery assembly, an attachment structure at the treatment site such that the attachment structure is attached to a first leaflet and a second leaflet. Methods comprise lacerating the first leaflet and the second leaflet to provide a passageway to a valve prosthesis, the attachment structure maintaining a first leaflet portion of the first leaflet in a fixed position relative to a second leaflet portion of the second leaflet such that the first leaflet and the second leaflet are offset from a first ostia and a second ostia.

[0020] In aspects, the first leaflet and the second leaflet comprise native leaflets of the native heart valve.

[0021] In aspects, the first leaflet and the second leaflet comprise prosthetic leaflets of a valve prosthesis.

[0022] In aspects, the attachment structure applies a compressive force to the first leaflet portion and the second leaflet portion.

[0023] In aspects, the attachment structure extends through a first leaflet opening in the first leaflet portion and a second leaflet opening in the second leaflet portion.

[0024] In aspects, methods of providing anchoring for a valve prosthesis are provided. Methods comprise positioning a distal end of a delivery assembly at a treatment site. Methods comprise deploying, from the delivery assembly, an attachment structure at the treatment site such that the attachment structure is attached to a first leaflet and a second leaflet that are adjacent to the treatment site. Methods comprise delivering a valve prosthesis to the treatment site, the attachment structure maintaining a first leaflet portion of the first leaflet in a fixed position relative to a second leaflet portion of the second leaflet such that the first leaflet and the second leaflet remain attached to the attachment structure during expansion of the valve prosthesis at the treatment site.

[0025] In aspects, the first leaflet and the second leaflet comprise native, non- calcified leaflets of the native heart valve.

[0026] In aspects, the attachment structure applies a compressive force to the first leaflet portion and the second leaflet portion.

[0027] In aspects, the attachment structure extends through a first leaflet opening in the first leaflet portion and a second leaflet opening in the second leaflet portion.

[0028] 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 incorporatedinto 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

[0029] 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:

[0030] FIG. 1 schematically illustrates example aspects of a transcatheter heart valve prosthesis in accordance with aspects of the disclosure;

[0031] FIG. 2 illustrates a top-down view of the transcatheter heart valve prosthesis in accordance with aspects of the disclosure;

[0032] FIG. 3 illustrates a side view of a delivery assembly for delivering the transcatheter heart valve prosthesis in accordance with aspects of the disclosure;

[0033] FIG. 4 illustrates a side view of the delivery assembly for delivering the transcatheter heart valve prosthesis in accordance with aspects of the disclosure;

[0034] FIG. 5 illustrates an introducer sheath in accordance with aspects of the disclosure;

[0035] FIG. 6 illustrates an introducer sheath in accordance with aspects of the disclosure;

[0036] FIG. 7 schematically illustrates a side view of the transcatheter heart valve prosthesis positioned at a treatment site in accordance with aspects of the disclosure;

[0037] FIG. 8 illustrates a top-down view of the treatment site in accordance with aspects of the disclosure;

[0038] FIG. 9 illustrates a top-down view similar to FIG. 8 with the heart valve prosthesis deployed at the treatment site in accordance with aspects of the disclosure;

[0039] FIG. 10 illustrates a top-down view of the treatment site in accordance with aspects of the disclosure;

[0040] FIG. 11 illustrates a top-down view of the treatment site in accordance with aspects of the disclosure;

[0041] FIG. 12 illustrates a side view of an attachment structure in a first position in accordance with aspects of the disclosure;

[0042] FIG. 13 illustrates a side view of the attachment structure in a second position in accordance with aspects of the disclosure;

[0043] FIG. 14 illustrates a portion of the delivery assembly at a treatment site in accordance with aspects of the disclosure;

[0044] FIG. 15 illustrates a portion of the delivery assembly comprising flexible arms at the treatment site in accordance with aspects of the disclosure;

[0045] FIG. 16 illustrates the flexible arms and the attachment structure in accordance with aspects of the disclosure;

[0046] FIG. 17 illustrates the flexible arms and the attachment structure in accordance with aspects of the disclosure;

[0047] FIG. 18 illustrates the flexible arms and the attachment structure in accordance with aspects of the disclosure;

[0048] FIG. 19 illustrates a top-down view of the treatment site in accordance with aspects of the disclosure; and

[0049] FIG. 20 illustrates a top-down view of the treatment site in accordance with aspects of the disclosure.DETAILED DESCRIPTION

[0050] 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.

[0051] 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.

[0052] 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.

[0053] 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.

[0054] 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.

[0055] 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.

[0056] The word “exemplary,” “example,” or various forms thereof are used herein to mean serving as an example, instance, or illustration. Any aspect or design described herein 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 appreciatedthat a myriad of additional or alternate examples of varying scope could have been presented but have been omitted for purposes of brevity.

[0057] 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 non-exclusive list, such that elements in addition to those specifically recited in the list may also be present.

[0058] 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.

[0059] 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.

[0060] Unless otherwise indicated, the terms “distal” 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 deployed configuration or vice versa. Non-exhaustive exemplary self-expanding materials include stainless steel, a pseudoelastic 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, trans-polyisoprene, 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.

[0061] 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.

[0062] 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 the treatment 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.

[0063] FIGS. 1 and 2 illustrate an example transcatheter heart valve prosthesis 10. The delivery assemblies described herein may be used with the transcatheter heart valveprosthesis 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.

[0064] 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.

[0065] 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 valve20 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 leaflets21 open and close to regulate flow through the transcatheter heart valve prosthesis 10.

[0066] As shown in FIG. 1, the transcatheter heart valve prosthesis 10 extends between a first end 11 and a second end 12. The prosthetic leaflets 21 are attached to the frame 15 at commissures 25 such that when pressure at one end exceeds pressure at an opposing end, the prosthetic leaflets 21 open to allow blood flow through the heart valve prosthesis 10 from the first end 11 to the second end 12. When the pressure at one end exceeds pressure at the other end, the prosthetic leaflets 21 close to prevent blood flow from the second end 12 to the first 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 commissurebracket, 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 second 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.

[0067] 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 first end 11 and the second 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.

[0068] 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. Although not shown, in some embodiments the transcatheter heart valve prosthesis 10 may includean outer skirt extending circumferentially around an outer circumference of the stent 15 at or near the first end 11 to prevent paravalvular leakage of blood around the outside of the transcatheter heart valve prosthesis 10 once implanted in the patient.

[0069] 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.

[0070] 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 33 with 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.

[0071] 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 transcatheterheart 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).

[0072] 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 and leads to increased risk to the patient. Expandable sheaths can be expanded within the body and thus do not require removal to upsize.

[0073] 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 ormore 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.

[0074] 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.

[0075] 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.

[0076] In certain embodiments, the expandability of the shaft 55 (and any shaft described according to any embodiment set forth herein) is achieved via the elasticity of the shaft 55, which can result in the shaft 55 being either self-expandable or self-expanding 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 expansionof the shaft 55, as depicted in FIG. 6. Alternatively, the expandable characteristics of the shaft 55 can be caused by something other than elasticity.

[0077] 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.

[0078] 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 nonlimiting example, the introducer sheath 50 is described as being an expandable introducer sheath 50 for introduction of a delivery assembly 30 including a transcatheter heart valve prosthesis 10.

[0079] 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. Although disclosed withrespect to placement of the heart valve prosthesis 10 within a native anatomy of the patient, in aspects, the heart valve prosthesis 10 can be implanted within a previously implanted prosthetic valve (e.g., a surgical or transcatheter index valve) to facilitate a valve-in-valve (e.g., TAV-in-SAV or TAV-in-TAV) procedure, without departing from the scope of the disclosure. 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 13 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 first end 11, a second section 715 at the second 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, as discussed above, 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 first end 11 to prevent paravalvular leakage of blood around the outside of the transcatheter heart valve prosthesis 10 once implanted in the patient. Thus, features of the disclosure may be employed alone or in combination with a heart valve prosthesis 10 having an outer skirt or other external sealing member (not shown) or a heart valve prosthesis 10 having no outer skirt.

[0080] FIG. 8 illustrates a top-down view of the treatment site 701 without the heart valve prosthesis 10, wherein the treatment site 701 comprises an aortic valve in a view from the aorta. The native aortic valve can comprise three leaflets or cusps, for example, a first native leaflet 801, a second native leaflet 803, and a third native leaflet 805. The treatment site 701 comprises a first coronary artery 809 (e.g., right coronary artery), which comprises a first ostia 810 or opening in the sinus of Valsalva, and a second coronary artery 811, which comprises a second ostia 812 or opening in the sinus of Valsalva. The native leaflets 801, 803, 805 can be joined at native commissures 815, 817,819. For example, the first native commissure 815 is where the first native leaflet 801 and the second native leaflet 803 are joined. The second native commissure 817 is where the second native leaflet 803 and the third native leaflet 805 are joined. The third native commissure 819 is where the first native leaflet 801 and the third native leaflet 805 are joined. It will be appreciated that the native commissures 815, 817, 819 may not be in the same location for all patients, and, in aspects, a patient-specific variation of 10-20 degrees is possible. In this way, the native commissures 815, 817, 819 may not be exactly 120 degrees apart. Rather, in aspects, the first native commissure 815 and the second native commissure 817 can be closer, for example, about 108 degrees apart. Likewise, the location of the ostia 810, 812 may vary approximately 15-20 degrees depending on patient anatomy.

[0081] FIG. 9 illustrates the treatment site 701 of FIG. 8 after the delivery and deployment of the valve prosthesis 10 at the treatment site 701. For example, the valve prosthesis 10 can comprise a first commissure 901, a second commissure 903, and a third commissure 905 attached to the frame 15, with the commissures 901, 903, 905 substantially identical to the commissures 25 of FIG. 2. In aspects, the valve prosthesis 10 can be positioned such that the first commissure 901 is placed at a substantially identical position as the first native commissure 815, the second commissure 903 is placed at a substantially identical position as the second native commissure 817, and the third commissure 905 is placed at a substantially identical position as the third native commissure 819. The valve prosthesis 10 can comprise one or more leaflets, for example, a first leaflet 907, a second leaflet 909, and a third leaflet 911, with the first leaflet 907 placed at a substantially identical position as the first native leaflet 801, the second leaflet 909 placed at a substantially identical position as the second native leaflet 803, and the third leaflet 911 placed at a substantially identical position as the third native leaflet 805. In this way, the first commissure 901 is where a first pair of the leaflets 907, 909 are attached, with the first commissure 901 attached to the frame 15. The second commissure 903 is where a second pair of the leaflets 909, 911 are attached, with the second commissure 903 attached to the frame 15. The third commissure 905 is where a third pair of the leaflets 907, 911 are attached, with the third commissure 905 attached to the frame 15.

[0082] In aspects, subsequent to the delivery and deployment in situ of the valve prosthesis 10 at the treatment site 701, access to one or both of the first coronary artery 809 or the second coronary artery 811 through the first ostia 810 and / or the second ostia 812 may be necessary. For example, a physician may need to access the first coronary artery809 and / or the second coronary artery 811 with a coronary guide catheter 915. To limit the likelihood of obstructing the first coronary artery 809 and / or the second coronary artery 811 and, thus, blocking the coronary guide catheter 915 from passing through the first ostia810 and / or the second ostia 812, the valve prosthesis 10 can be positioned such that the struts 16 of the frame 15, the commissures 901, 903, 905, and the prosthetic valve 20 do not obstruct the first ostia 810 and the second ostia 812. For example, a first radial axis 921 can intersect the longitudinal axis LA and pass through the first ostia 810 and the first coronary artery 809. The first radial axis 921 may be perpendicular to the longitudinal axis LA, and the first radial axis 921 may not intersect or pass through the struts 16 of the frame 15, the commissures 901, 903, 905, or the prosthetic valve 20. Likewise, a second radial axis 923 can intersect the longitudinal axis LA and pass through the second ostia 812 and the second coronary artery 811. The second radial axis 923 may be perpendicular to the longitudinal axis LA, and the second radial axis 923 may not intersect or pass through the struts 16 of the frame 15, the commissures 901, 903, 905, or the prosthetic valve 20. Accordingly, in this way, the valve prosthesis 10 can be positioned to rotationally align the prosthetic commissures and leaflets with the native commissures and leaflets, while also not blocking or obstructing the ostia 810, 812, thus allowing subsequent access to the coronary arteries 809, 811 via the coronary guide catheter 915. In aspects, the valve prosthesis 10 can be rotationally aligned such that the larger access cells (e.g., access cell(s) 23) can be aligned with the ostia 810, 812 to facilitate subsequent access. In aspects, the valve prosthesis 10 can be rotated during the delivery and deployment of the valve prosthesis 10 to further facilitate rotational alignment of the valve prosthesis 10 relative to the native commissures and leaflets while not blocking or obstructing the ostia 810, 812. As will be described below, to further limit the likelihood of obstruction of the ostia 810, 812, leaflets (e.g., the native leaflets and / or the prosthetic leaflets during a valve-in-valve procedure) may be attached to one another to restrict movement of the leaflets, thus limiting the leaflets from blocking the ostia 810, 812.

[0083] FIG. 10 illustrates a top-down view of the treatment site 701 similar to FIGS. 8-9. In aspects, to further limit the likelihood of obstructing the first coronary artery 809 and / or the second coronary artery 811, one or more attachment structures 1001 can be attached to leaflets. While FIG. 10 illustrates the attachment structures 1001 attached to the native leaflets 801, 803, 805, the attachment structures 1001 can, additionally, or alternatively, be attached to the prosthetic leaflets 907, 909, 911 of the heart valve prosthesis 10 (e.g., as illustrated in FIGS. 19-20). For example, in aspects, it may be desirable to deploy a second heart valve prosthesis (e.g., 2001 in FIG. 20) within the heart valve prosthesis 10 as part of a ‘valve-in-valve’ procedure. In such cases, it is beneficial to provide the attachment structures 1001 to attach to the prosthetic leaflets 907, 909, 911 to limit the prosthetic leaflets 907, 909, 911 from obstructing the first coronary artery 809 and / or the second coronary artery 811. Accordingly, the examples of attachment structures 1001 described herein, along with the described methods of implanting and attaching the attachment structures 1001, are applicable to either, or both, the native leaflets 801, 803, 805 and / or the prosthetic leaflets 907, 909, 911 of the existing, already implanted, heart valve prosthesis 10.

[0084] As illustrated in FIG. 10, the attachment structures 1001 can be positioned within a channel of the native heart valve 703, which can comprise the leaflets 801, 803, 805. In aspects, one or more attachment structures 1001 can be attached to one or more of the leaflets 801, 803, 805. For example, one attachment structure 1001 can be attached to the first leaflet 801 and the second leaflet 803, a second attachment structure 1001 can be attached to the second leaflet 803 and the third leaflet 805, and a third attachment structure 1001 can be attached to the first leaflet 801 and the third leaflet 805. By being attached, the attachment structures 1001 can attach a leaflet to a neighboring or adjacent leaflet. In aspects, the attachment structures 1001 can be positioned in proximity to the commissures 815, 817, 819 (e.g., with the commissures 815, 817, 819 illustrated in FIG. 8). For example, a distance separating the attachment structure 1001 (e.g., that attaches the first leaflet 801 and the second leaflet 803) from the first commissure 815 may be less than the distance separating the attachment structure 1001 from a center of the native heart valve 703. By positioning the attachment structures 1001 in proximity to the commissures 815, 817, 819, the attachment structures 1001 can limit the likelihood of the leaflets 801, 803,805 from moving and obstructing the coronary arteries 809, 811 while also not blocking or obstructing the subsequent positioning and deployment of the heart valve prosthesis 10 within the native heart valve 703.

[0085] After the attachment of the attachment structures 1001 to the leaflets 801, 803, 805, the leaflets 801, 803, 805 may, in aspects, be lacerated to allow for the positioning and deployment of the heart valve prosthesis 10. For example, the lacerations 1005, 1007 are illustrated generically in FIG. 10 with dashed lines to illustrate an example position of the lacerations 1005, 1007 relative to the leaflets 801, 803, 805. For example, in aspects, the first leaflet 801 may comprise a laceration 1005 to separate the first leaflet 801 into a pair of first leaflet portions 1011. In aspects, the second leaflet 803 may comprise a laceration 1007 to separating the second leaflet 803 into a pair of second leaflet portions 1013. The attachment structure 1001 can attach the first leaflet portion 1011 of the first leaflet 801 to the second leaflet portion 1013 of the second leaflet 803, such that the first leaflet portion 1011 and the second leaflet portion 1013 may be maintained in a fixed position relative to one another. The other attachment structures 1001 can function in a substantially similar manner.

[0086] FIG. 11 illustrates the heart valve prosthesis 10 deployed within the native heart valve 703 after the attachment of the attachment structures 1001 and formation of the lacerations 1005, 1007. As illustrated, the leaflets 801, 803, 805 and the attachment structures 1001 can be positioned at a location that is radially exterior from the heart valve prosthesis 10. Due to the attachment structure 1001 that attaches the first leaflet portion 1011 to the second leaflet portion 1013, and due to the attachment structure 1001 that attaches the second leaflet portion 1013 to the third leaflet 805, a passageway 1101 is provided between the pair of second leaflet portions 1013 through which access can be gained to the second coronary artery 811. Likewise, due to the attachment structure 1001 that attaches the first leaflet portion 1011 to the second leaflet portion 1013, and due to the attachment structure 1001 that attaches the first leaflet portion 1011 to the third leaflet 805, another passageway 1103 is provided between the pair of first leaflet portions 1011 through which access can be gained to the first coronary artery 809. In this way, the attachment structures 1001 can support the leaflet portions at a location that is separated a distance from the coronary arteries 809, 811, thus reducing the likelihood of blockage by the leaflets.

[0087] FIG. 12 illustrates an example of the attachment structure 1001 being positioned relative to a pair of leaflets 801, 803. While the first leaflet 801 and the second leaflet 803 are illustrated in FIG. 12, the attachment structure 1001 can be attached in a substantially identical manner to any of the leaflets 801, 803, 805 and / or prosthetic leaflets 907, 909, 911. The transcatheter valve apparatus can comprise a placement structure 1200 comprising a first flexible arm 1201 and a second flexible arm 1203. The first flexible arm 1201 and the second flexible arm 1203 can move between a first position and a second position. In the first position, the first flexible arm 1201 and the second flexible arm 1203 are outside of the capsule 35 and a first separating distance separates the first flexible arm 1201 from the second flexible arm 1203. For example, the first separating distance is illustrated in FIG. 12 and separates arm ends 1205, 1207 of the flexible arms 1201, 1203. In the second position (e.g., illustrated in FIG. 13), the first flexible arm 1201 and the second flexible arm 1203 are retracted into the capsule 35 and a second separating distance separates the first flexible arm 1201 from the second flexible arm 1203. The second separating distance is illustrated in FIG. 13 and separates arm ends 1205, 1207 of the flexible arms 1201, 1203. The second separating distance is less than the first separating distance. The placement structure 1200 is also illustrated and described relative to FIGS. 15-18. In aspects, the attachment structure 1001 can be attached to the pair of flexible arms 1201, 1203 that can extend at least partially within and from the capsule 35. The first flexible arm 1201 can terminate at the first arm end 1205, and the second flexible arm 1203 can terminate at the second arm end 1207. In aspects, the first arm end 1205 and the second arm end 1207 may be removably attached to the attachment structure 1001. While several orientations are possible, in aspects, the first flexible arm 1201 may be non-parallel relative to the second flexible arm 1203, with a distance separating the first flexible arm 1201 from the second flexible arm 1203 increasing in a distal direction away from the capsule 35 and toward the arm ends 1205, 1207.

[0088] In aspects, the attachment structure 1001 can comprise a non-linear shape, for example, a rounded or curved shape, with a first attachment portion 1211 and a second attachment portion 1213. The first attachment portion 1211 can terminate at a first attachment end 1217 and the second attachment portion 1213 can terminate at a second attachment end 1219. The attachment structure 1001 can comprise an intermediate portion1223 that extends between, and is attached to, the first attachment portion 1211 and the second attachment portion 1213. In aspects, the intermediate portion 1223 may be in contact with the first flexible arm 1201 and the second flexible arm 1203. The first attachment portion 1211 and the second attachment portion 1213 can project from the intermediate portion 1223 in a distal direction away from the flexible arms 1201, 1203. In aspects, the first attachment portion 1211 and the second attachment portion 1213 can be attached, for example, due to the intermediate portion 1223 being attached at opposing ends to the first attachment portion 1211 and the second attachment portion 1213.

[0089] The attachment structure 1001 can comprise several materials, for example, metal materials, titanium, nitinol, etc. In aspects, when the attachment structure 1001 comprises nitinol, the attachment structure 1001 can be biased to the shape illustrated in FIG. 13. For example, FIG. 12 illustrates the attachment structure 1001 in a first position, in which the first attachment portion 1211 (e.g., the first attachment end 1217), is spaced a first distance 1227 from the second attachment portion 1213 (e.g., the second attachment end 1219). In this way, with the first attachment end 1217 and the second attachment end 1219 spaced the first distance 1227, an attachment opening 1229 can be defined between the first attachment portion 1211 (e g., the first attachment end 1217) and the second attachment portion 1213 (e.g., the second attachment end 1219).

[0090] In aspects, to maintain the attachment structure 1001 in the first position, a holding structure 1233 can be positioned between the first attachment portion 1211 and the second attachment portion 1213. For example, the holding structure 1233 can occupy a portion of the attachment opening 1229 and may be in contact with the first attachment end 1217 and the second attachment end 1219. In this way, the holding structure 1233 can comprise a width that substantially matches the first distance 1227, such that the holding structure 1233 can maintain the first attachment end 1217 in a spaced apart configuration from the second attachment end 1219. In aspects, the holding structure 1233 may not occupy all of the attachment opening 1229, such that portions of the leaflets (e.g., 801, 803) may still be positioned within the attachment opening 1229 without being obstructed by the holding structure 1233. To properly position the attachment structure 1001 relative to the leaflets such that the leaflets are within the attachment opening 1229, the flexible arms 1201, 1203 can be moved in a distal direction, thus causing the attachment structure 1001to move such that the first leaflet 801 (e.g., the first leaflet portion 1011) and the second leaflet 803 (e.g., the second leaflet portion 1013) can be received within the attachment opening 1229.

[0091] FIG. 13 illustrates the attachment structure 1001 in a second position after moving from the first position (e.g., illustrated in FIG. 12). For example, to move the attachment structure 1001 from the first position to the second position, the holding structure 1233 can be removed from the attachment opening 1229. In aspects, the holding structure 1233 can be retracted, for example, by the capsule 35 and / or by the flexible arms 1201, 1203. That is, the holding structure 1233 can be attached or operatively connected to the flexible arms 1201, 1203 such that, as the flexible arms 1201, 1203 are retracted and moved in a proximal direction away from the attachment structure 1001, the holding structure 1233 may likewise be retracted and moved out of the attachment opening 1229 and toward the capsule 35. In aspects, the capsule 35 can be moved in a distal direction relative to the flexible arms 1201, 1203 and toward the attachment structure 1001, which can cause the flexible arms 1201, 1203 to be retracted into the capsule 35. The retraction of the flexible arms 1201, 1203 into the capsule 35 can cause the flexible arms 1201, 1203 to separate from the attachment structure 1001 and, in aspects, may cause the ends 1205, 1207 of the flexible arms 1201, 1203 to move closer together.

[0092] In aspects, upon removing the holding structure 1233 from the attachment opening 1229, the attachment structure 1001 can move from the first position to the second position due to the attachment structure 1001 being biased toward the second position. Due to the first leaflet portion 1011 and the second leaflet portion 1013 being received within the attachment opening 1229 when the attachment structure 1001 is in the first position (e.g., illustrated in FIG. 12), the first leaflet portion 1011 and the second leaflet portion 1013 may remain between the first attachment end 1217 and the second attachment end 1219 when the attachment structure 1001 moves to the second position. For example, with the attachment structure 1001 in the second position, the first leaflet portion 1011 and the second leaflet portion 1013 may remain within the attachment opening 1229, and the first attachment portion 1211 (e.g., the first attachment end 1217) may be spaced a second distance 1301 from the second attachment portion 1213 (e.g., the second attachment end 1219). The second distance 1301 may be less than the first distance 1227.

[0093] In aspects, the first attachment portion 1211 and the second attachment portion 1213 can apply a compressive force to the first leaflet portion 1011 of the first leaflet 801 and to the second leaflet portion 1013 of the second leaflet 803 when the first attachment portion 1211 and the second attachment portion 1213 are in the second position. By applying a compressive force to the leaflet portions 1011, 1013, the attachment portions 1211, 1213 can maintain the position of the leaflet portions 1011, 1013 between the attachment ends 1217, 1219, thus reducing the likelihood of detachment of the attachment structure 1001 from the leaflet portions 1011, 1013. In addition, or in the alternative, the attachment ends 1217, 1219 can puncture the leaflet portions 1011, 1013, such that the attachment ends 1217, 1219 can extend through openings formed in the leaflet portions 1011, 1013. Accordingly, the first attachment portion 1211 and the second attachment portion 1213 can maintain the first leaflet portion 1011 in a fixed position relative to the second leaflet portion 1013 such that the first leaflet portion 1011 and the second leaflet portion 1013 are offset from the first ostia 810 and / or the second ostia 812. While FIGS. 12-13 illustrate the attachment of one attachment structure 1001 to one pair of leaflets (e.g., the first leaflet 801 and the second leaflet 803), the process can subsequently be repeated in a substantially identical manner with the other leaflets, for example, with an attachment structure 1001 attaching the second leaflet 803 and the third leaflet 805, and another attachment structure 1001 attaching the first leaflet 801 and the third leaflet 805.

[0094] FIGS. 14-18 illustrate further details related to the positioning and attachment of attachment structures to leaflets. It will be appreciated that while FIGS. 14- 18 are illustrated relative to the native leaflets 801, 803, 805, a substantially identical process of positioning and attachment of the attachment structures can occur relative to the prosthetic leaflets 907, 909, 911 of the heart valve prosthesis 10 that has already been deployed (e.g., as part of a valve-in-valve procedure). Accordingly, the description related to FIGS. 14-18 is not intended to be limited to only attachment structures that are attached to native leaflets 801, 803, 805, but also can apply to attachment structures attached to prosthetic leaflets of an already -implanted heart valve prosthesis.

[0095] Referring to FIG. 14, initially, the delivery assembly 30 (e.g., also illustrated in FIGS. 3-4) can be moved in a distal direction 1401 toward the treatment site 701 (e.g., also illustrated in FIG. 7), such that the delivery assembly 30 is positionedbetween two leaflets, for example, the first native leaflet 801 and the second native leaflet 803. Accordingly, methods of providing access to one or more ostia 810, 812 can comprise positioning the distal end 31 of the delivery assembly 30 at the treatment site 701. As illustrated in FIG. 15, the capsule 35 can be retracted such that the first flexible arm 1201 and the second flexible arm 1203 can be deployed and moved apart. The flexible arms 1201, 1203 can be positioned radially exterior from the first leaflet 801 and the second leaflet 803. For example, the first leaflet 801 and the second leaflet 803 can be positioned between the first flexible arm 1201 and the second flexible arm 1203. In aspects, the first flexible arm 1201 may be adjacent to or in contact with an outer radial side of the first leaflet 801, and the second flexible arm 1203 may be adjacent to or in contact with an outer radial side of the second leaflet 803.

[0096] FIG. 16 illustrates a close-up view of the flexible arms 1201, 1203. In aspects, the flexible arms 1201, 1203 can be attached to an attachment structure 1001 that comprises a first attachment portion 1603 and a second attachment portion 1605. The first attachment portion 1603 can be attached to and supported by the first flexible arm 1201 while the second attachment portion 1605 can be attached to and supported by the second flexible arm 1203. The attachment portions 1603, 1605 can be attached to the flexible arms 1201, 1203 in several ways. For example, and as illustrated in FIG. 16, the first flexible arm 1201 can comprise a slot within which the first attachment portion 1603 may be removably received. Likewise, the second flexible arm 1203 can comprise a slot within which the second attachment portion 1605 may be removably received. In addition, or in the alternative, one or more mechanical fasteners can be used to removably attach the first attachment portion 1603 to the first flexible arm 1201 and the second attachment portion 1605 to the second flexible arm 1203. As illustrated in FIG. 16, the flexible arms 1201, 1203 can move the attachment structure 1001 to a similar position as the attachment structure 1001 illustrated in FIG. 12.

[0097] In aspects, to facilitate positioning of the attachment structure 1001 relative to the leaflets, a wire 1607 can extend between the first attachment portion 1603 and the second attachment portion 1605. The wire 1607 can be attached at opposing ends to the flexible arms 1201, 1203, or may be attached at opposing ends to the attachment portions 1603, 1605. When the flexible arms 1201, 1203 are in a fully extended position in whichdistal ends of the flexible arms 1201, 1203 are at a maximum separating distance, the wire 1607 may be substantially taut and may extend substantially linearly. In aspects, the distance separating the wire 1607 and the capsule 35 may be less than the distance separating the attachment portions 1603, 1605 and the capsule 35.

[0098] FIG. 17 illustrates movement of the capsule 35 in a distal direction, which can cause the flexible arms 1201, 1203 to move closer to one another. For example, and as described relative to FIGS. 12-13, the capsule 35 can be moved in the distal direction, which can cause the flexible arms 1201, 1203 to be retracted into the capsule 35. As a result, the flexible arms 1201, 1203 can be moved closer together, such that a separating distance between the ends of the flexible arms 1201, 1203 decreases. The wire 1607 can be in contact with the leaflets 801, 803 as the flexible arms 1201, 1203 are retracted, such that the wire 1607 may no longer be taut and may bend. In this way, the wire 1607 can serve as a visual indicator (e.g., when viewed via an imaging technique such as, for example, fluoroscopy) that the attachment structure 1001 is in a desired position relative to the leaflets 801, 803. For example, the wire 1607 can be bent in a peak-shaped formation in which the center of the wire 1607 is in closer proximity to the capsule 35 than the ends of the wire. This shape can serve as an indication that the wire 1607 is in contact with the leaflets 801, 803 such that the first attachment portion 1603 and the second attachment portion 1605 are on opposing sides of the leaflets 801, 803. In contrast, if the wire 1607 has a different shape, such as a valley-shaped formation in which the center of the wire 1607 is farther from the capsule 35 than the ends of the wire, then such a shape can serve as an indication that the wire 1607 is not in contact with the leaflets 801, 803 and that the attachment portions 1603, 1605 are not properly positioned relative to the leaflets 801, 803.

[0099] Referring to FIGS. 17-18, the distal ends of the flexible arms 1201, 1203 may be brought together such that the distance separating the first attachment portion 1603 and the second attachment portion 1605 decreases. That is, initially and as illustrated in FIG. 16, the first attachment portion 1603 is separated the first distance 1227 from the second attachment portion 1605, such that the leaflets 801, 803 can be received within the attachment opening 1229 between the first attachment portion 1603 and the second attachment portion 1605. However, as illustrated in FIG. 18, the first attachment portion 1603 and the second attachment portion 1605 can be moved closer together (e.g., due tothe movement of the flexible arms 1201, 1203), such that the second distance 1301 can separate first attachment portion 1603 and the second attachment portion 1605. The first attachment portion 1603 and the second attachment portion 1605 can be attached in several ways. For example, as illustrated in FIG. 18, the first attachment portion 1603 can comprise an extension portion 1801 that extends outwardly from the first attachment portion 1603. The extension portion 1801 can protrude through the leaflets 801, 803. For example, the extension portion 1801 can puncture the leaflets 801, 803 as the first attachment portion 1603 and the second attachment portion 1605 are moved together. In aspects, the extension portion 1801 can puncture the first leaflet 801 to form a first leaflet opening in the first leaflet 801 and can puncture the second leaflet 803 to form a second leaflet opening in the second leaflet 803. In this way, the extension portion 1801 of the attachment structure 1001 can pass through the first leaflet opening and the second leaflet opening. In aspects, the second attachment portion 1605 can comprise an opening (e.g., a slot, a channel, etc.) that is sized to receive the extension portion 1801. In this way, the extension portion 1801 can be received within the opening of the second attachment portion 1605 in a fixed and non-removable manner. Accordingly, the extension portion 1801 can function to attach the first attachment portion 1603 to the second attachment portion 1605, with the attachment portions 1603, 1605 attached to, and providing a compressive force to, the leaflets 801, 803. As such, methods can comprise deploying, from the delivery assembly 30, the attachment structure 1001 at the treatment site 701 such that the attachment structure 1001 is attached to the first leaflet 801 and the second leaflet 803, wherein the leaflets 801, 803 are adjacent to the treatment site 701.

[0100] FIG. 19 illustrates the attachment structures 1001 attached to the transcatheter heart valve prosthesis 10. In this way, the attachment structures 1001 can be used as part of a valve-in-valve procedure. For example, the valve prosthesis 10 can comprise the plurality of prosthetic leaflets 21 attached to the frame 15. In aspects, the plurality of prosthetic leaflets 21 can comprise the first leaflet 907, the second leaflet 909, and the third leaflet 911. The attachment structures 1001 can be positioned within the valve prosthesis 10. For example, one attachment structure 1001 can be attached to the first leaflet 907 and the second leaflet 909, a second attachment structure 1001 can be attached to the second leaflet 909 and the third leaflet 911, and a third attachment structure 1001can be attached to the first leaflet 907 and the third leaflet 911. The attachment structures 1001 can be attached to the plurality of prosthetic leaflets 21 in substantially the same manner as described herein relative to FIGS. 12-18. In this way, the attachment structure 1001 can maintain the first leaflet 907 in a fixed position relative to the second leaflet 909. Likewise, the second attachment structure 1001 can maintain the second leaflet 909 in a fixed position relative to the third leaflet 911, and the third attachment structure 1001 can maintain the first leaflet 907 in a fixed position relative to the third leaflet 911. As such, in this way, with the attachment structures 1001 maintaining the leaflets 907, 909, 911 in a fixed position relative to one another, the plurality of prosthetic leaflets 21 are offset from the first ostia 810 and the second ostia 812. Following the attachment of the attachment structures 1001 to the plurality of prosthetic leaflets 21, methods can comprise lacerating the first leaflet 907 and the second leaflet 909 to provide a passageway to a second valve prosthesis 2001 (e.g., illustrated in FIG. 20).

[0101] FIG. 20 illustrates the second valve prosthesis 2001 positioned within the valve prosthesis 10 of FIG. 19. In aspects, the second valve prosthesis 2001 may be similar in some respects to the valve prosthesis 10, or may be substantially identical to the valve prosthesis 10. For example, the second valve prosthesis 2001 can comprise a second frame 2003 (e.g., which may be similar or identical to the frame 15 of the valve prosthesis 10). Likewise, the second valve prosthesis 2001 can comprise a plurality of second prosthetic leaflets 2005 (e.g., which may be similar or identical to the plurality of prosthetic leaflets 21 of the valve prosthesis 10) that may be attached to the second frame 2003. In this way, by being positioned within the valve prosthesis 10, the second valve prosthesis 2001 may be positioned radially-inward from the attachment structures 1001. The attachment structures 1001 can maintain the plurality of prosthetic leaflets 21 in a fixed position, which allows for the passageway 1101 to the second coronary artery 811 and the passageway 1103 to the first coronary artery 809. Accordingly, the attachment structures 1001 can maintain the plurality of prosthetic leaflets 21 in the fixed position between the frame 15 of the valve prosthesis 10 on a radially outward side of the attachment structures 1001 and the second frame 2003 of the second valve prosthesis 2001 on a radially inward side of the attachment structures 1001.

[0102] It will be appreciated that the disclosure is not limited to the attachment structures 1001 illustrated and described herein. Rather, attachment structures of differing shapes and functions can be provided to restrict movement of the leaflets. For example, some attachment structures may provide compressive force to attach two leaflets together without puncturing the leaflets. Alternatively, other attachment structures may not provide a compressive force to the leaflets, but, rather, may puncture two leaflets to attach the leaflets together. As such, while two shapes of attachment structures are illustrated and described herein, additional shapes of the attachment structures are possible.

[0103] While the disclosure has related, at least in part, to the attachment of the attachment structures 1001 to the plurality of prosthetic leaflets 21, the attachment structures 1001 are not limited to such a position. Rather, in addition, or in the alternative, the attachment structures 1001 can, instead, be attached to one or more of the native leaflets 801, 803, 805. For example, aortic regurgitation (AR) may occur when the native aortic valve (e.g., illustrated in FIGS. 7-8) does not close properly due to damage to the native leaflets 801, 803, 805 or as a result of dilation of the aortic annulus, which may occur with non-calcified native leaflets. In this way, aortic regurgitation can pose challenges when implanting the valve prosthesis 10 at the treatment site 701

[0104] In a situation when aortic regurgitation occurs, the attachment structures 1001 can be used for attachment to the native leaflets 801, 803, 805 prior to the deployment of the valve prosthesis 10 at the treatment site 701. In this way, and with reference to FIG. 8, one attachment structure 1001 can be attached to the first native leaflet 801 and the second native leaflet 803 adjacent to the first native commissure 815, another attachment structure 1001 can be attached to the first native leaflet 801 and the third native leaflet 805 adjacent to the third native commissure 819, and a third attachment structure 1001 can be attached to the second native leaflet 803 and the third native leaflet 805 adjacent to the second native commissure 817. The attachment structures 1001 can be deployed and attached to the native leaflets 801, 803, 805 in a substantially identical manner as described relative to FIGS. 9-20 in which the attachment structure 1001 are deployed and attached to the prosthetic leaflets. That is, the capsule 35 and the placement structure 1200 (e.g., illustrated in FIGS. 12-17) can be used to attach the attachment structures 1001 to the native leaflets 801, 803, 805 in substantially the same manner asillustrated and described relative to FIGS. 12-17. Likewise, the attachment structures 1001 that are attached to the native leaflets 801, 803, 805 can be substantially identical in structure and function to the attachment structures 1001 that are attached to the prosthetic leaflets. Accordingly, the attachment structures 1001, when attached to the native leaflets 801, 803, 805, can function to stiffen the native leaflets 801, 803, 805 and may function similarly to calcium nodules by facilitating anchoring of the valve prosthesis 10 at the treatment site 701. In particular, the attachment structures 1001, when attached to the native leaflets 801, 803, 805, can cause the native commissures to fuse, thus providing a more restricted opening to anchor the valve prosthesis 10 (e.g., due to the absence of calcified leaflets, which may otherwise be relied on for anchoring). Further, the attachment structures 1001 can help reduce the likelihood of a paravalvular leak (PVL) at the native commissures 815, 817, 819.

[0105] Accordingly, in this way, methods of providing anchoring for the valve prosthesis 10 are provided, for example, by attaching the attachment structures 1001, to the native leaflets 801, 803, 805. In aspects, methods can comprise deploying, from the delivery assembly 30, the attachment structures 1001 at the treatment site 701 such that the attachment structure 1001 is attached to the first leaflet 801 and the second leaflet 803. Methods can comprise delivering the valve prosthesis 10 to the treatment site 701 (e.g., wherein the treatment site 701 is a location of the native aortic annulus 703 of a native heart valve, and wherein the treatment site 701 is adjacent to the native leaflets 705 and native sinuses 707). The attachment structure 1001 can maintain a first leaflet portion of the first leaflet 801 in a fixed position relative to a second leaflet portion of the second leaflet 803 such that the first leaflet 801 and the second leaflet 803 remain attached to the attachment structure 1001 during expansion of the valve prosthesis 10 at the treatment site 701. In aspects, the first leaflet 801 and the second leaflet can comprise native, noncalcified leaflets of the native heart valve. The attachment structure 1001 can apply a compressive force to the leaflet portions of the first leaflet 801 and the second leaflet 803, with the attachment structure 1001 extending through leaflet openings in the leaflet portions (e.g., in a substantially identical manner as illustrated and described relative to FIG. 18)

[0106] Furthermore, while the disclosure has related, at least in part, to the attachment of the attachment structures 1001 to the plurality of leaflets for the methods of anchoring a valve prosthesis 10, the attachment structures 1001 are not limited to such a method. Rather, in addition, or in the alternative, the attachment structures 1001 can, instead, be attached to one or more of the native leaflets 801, 803, 805, and no valve prosthesis is added. For example, aortic regurgitation (AR) may occur when the native aortic valve does not close properly due to damage to the native leaflets 801, 803, 805 or as a result of dilation of the aortic annulus, which may occur with non-calcified native leaflets. In this way, aortic regurgitation can pose challenges when implanting the valve prosthesis 10 at the treatment site 701. In a situation when aortic regurgitation occurs, the attachment structures 1001 can be used for attachment to the native leaflets 801, 803, 805 to cause the native commissures to fuse, thus providing a restrictive annuloplasty effect to reduce aortic regurgitation and obviate the need for the valve prosthesis 10. Accordingly, and as described herein, the attachment structures 1001 can be used in several scenarios to address multiple leaflet-related issues that may arise.

[0107] Aspect 1. A transcatheter valve apparatus comprises a first valve prosthesis comprising a plurality of prosthetic leaflets attached to a frame. The transcatheter valve apparatus comprises an attachment structure positioned within a channel of the valve prosthesis, the attachment structure attached to a first leaflet of the plurality of prosthetic leaflets and attached to a second leaflet of the plurality of prosthetic leaflets. The attachment structure is configured to maintain the first leaflet in a fixed position relative to the second leaflet such that the plurality of prosthetic leaflets are offset from a first ostia and a second ostia. The transcatheter valve apparatus comprises a second valve prosthesis comprising a plurality of second prosthetic leaflets attached to a second frame. The second valve prosthesis is positioned within the channel and radially inward from the attachment structure.

[0108] Aspect 2. The transcatheter valve apparatus of aspect 1 , wherein the attachment structure is configured to move between a first position, in which a first attachment portion of the attachment structure is spaced a first distance from a second attachment portion of the attachment structure such that an attachment opening is defined between the first attachment portion and the second attachment portion, and a secondposition, in which the first leaflet and the second leaflet are positioned within the attachment opening and the first attachment portion is spaced a second distance, which is less than the first distance, from the second attachment portion.

[0109] Aspect 3. The transcatheter valve apparatus of any one of aspects 1-2, wherein the first attachment portion and the second attachment portion apply a compressive force to the first leaflet and the second leaflet when the first attachment portion and the second attachment portion are in the second position.

[0110] Aspect 4. The transcatheter valve apparatus of any one of aspects 1-3, wherein the attachment structure comprises a nitinol material.

[0111] Aspect 5. The transcatheter valve apparatus of any one of aspects 1-4, wherein the attachment structure is biased toward the second position.

[0112] Aspect 6. The transcatheter valve apparatus of any one of aspects 1-5, further comprising a wire extending between the first attachment portion and the second attachment portion.

[0113] Aspect 7. The transcatheter valve apparatus of any one of aspects 1-6, wherein the attachment structure passes through a first leaflet opening in the first leaflet and a second leaflet opening in the second leaflet.

[0114] Aspect 8. A transcatheter valve apparatus comprises a delivery assembly configured to deliver a valve prosthesis to a treatment site. The delivery assembly comprises a capsule and a placement structure comprising a first flexible arm and a second flexible arm. The first flexible arm and the second flexible arm configured to move between a first position, in which the first flexible arm and the second flexible arm are outside of the capsule and a first separating distance separates the first flexible arm from the second flexible arm, and a second position, in which the first flexible arm and the second flexible arm are retracted into the capsule and a second separating distance separates the first flexible arm from the second flexible arm. The second separating distance is less than the first separating distance. An attachment structure is removably attached to the placement structure. The attachment structure comprises a first attachment portion removably attached to the first flexible arm. The attachment structure comprises a second attachment portion removably attached to the second flexible arm. The first attachment portion is configured to be detached from the first flexible arm and the secondattachment portion is configured to be detached from the second flexible arm such that the first attachment portion is in contact with a first leaflet portion of a first leaflet, and the second attachment portion is in contact with a second leaflet portion of a second leaflet. The first attachment portion and the second attachment portion maintain the first leaflet portion in a fixed position relative to the second leaflet portion such that the first leaflet portion and the second leaflet portion are offset from a first ostia and a second ostia.

[0115] Aspect 9. The transcatheter valve apparatus of claim 8, wherein the first leaflet and the second leaflet comprise native leaflets of the native heart valve.

[0116] Aspect 10. The transcatheter valve apparatus of any one of aspects 8-9, wherein the first leaflet and the second leaflet comprise prosthetic leaflets of a valve prosthesis.

[0117] Aspect 11. The transcatheter valve apparatus of any one of aspects 8-10, wherein the attachment structure is configured to move between a first position, in which the first attachment portion is spaced a first distance from the second attachment portion such that an attachment opening is defined between the first attachment portion and the second attachment portion, and a second position, in which the first leaflet portion and the second leaflet portion are positioned within the attachment opening and the first attachment portion is spaced a second distance, which is less than the first distance, from the second attachment portion.

[0118] Aspect 12. The transcatheter valve apparatus of any one of aspects 8-11, wherein the first attachment portion and the second attachment portion apply a compressive force to the first leaflet portion and the second leaflet portion when the first attachment portion and the second attachment portion are in the second position.

[0119] Aspect 13. The transcatheter valve apparatus of any one of aspects 8-12, wherein the attachment structure comprises a nitinol material.

[0120] Aspect 14. The transcatheter valve apparatus of any one of aspects 8-13, wherein the attachment structure comprises a wire extending between the first attachment portion and the second attachment portion.

[0121] Aspect 15. The transcatheter valve apparatus of any one of aspects 8-14, wherein the attachment structure comprises an extension portion that extendsoutwardly from the first attachment portion and passes through a first leaflet opening in the first leaflet portion and a second leaflet opening in the second leaflet portion.

[0122] Aspect 16. Methods of providing access to one or more ostia comprise positioning a distal end of a delivery assembly at a treatment site. Methods comprise deploying, from the delivery assembly, an attachment structure at the treatment site such that the attachment structure is attached to a first leaflet and a second leaflet. Methods comprise lacerating the first leaflet and the second leaflet to provide a passageway to a valve prosthesis, the attachment structure maintaining a first leaflet portion of the first leaflet in a fixed position relative to a second leaflet portion of the second leaflet such that the first leaflet and the second leaflet are offset from a first ostia and a second ostia.

[0123] Aspect 17. The method of aspect 16, wherein the first leaflet and the second leaflet comprise native leaflets of the native heart valve.

[0124] Aspect 18. The method of any one of aspects 16-17, wherein the first leaflet and the second leaflet comprise prosthetic leaflets of a valve prosthesis.

[0125] Aspect 19. The method of any one of aspects 16-18, wherein the attachment structure applies a compressive force to the first leaflet portion and the second leaflet portion.

[0126] Aspect 20. The method of any one of aspects 16-19, wherein the attachment structure extends through a first leaflet opening in the first leaflet portion and a second leaflet opening in the second leaflet portion.

[0127] Aspect 21. Methods of providing anchoring for a valve prosthesis are provided. Methods comprise positioning a distal end of a delivery assembly at a treatment site. Methods comprise deploying, from the delivery assembly, an attachment structure at the treatment site such that the attachment structure is attached to a first leaflet and a second leaflet that are adjacent to the treatment site. Methods comprise delivering a valve prosthesis to the treatment site, the attachment structure maintaining a first leaflet portion of the first leaflet in a fixed position relative to a second leaflet portion of the second leaflet such that the first leaflet and the second leaflet remain attached to the attachment structure during expansion of the valve prosthesis at the treatment site.

[0128] Aspect 22. The method ofaspect 21, wherein the first leaflet and the second leaflet comprise native, non-calcified leaflets of the native heart valve.

[0129] Aspect 23. The method of aspect 21, wherein the attachment structure applies a compressive force to the first leaflet portion and the second leaflet portion.

[0130] Aspect 24. The method of aspect 21, wherein the attachment structure extends through a first leaflet opening in the first leaflet portion and a second leaflet opening in the second leaflet portion.

[0131] 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.

Claims

What is claimed is:

1. A transcatheter valve apparatus comprising: a valve prosthesis comprising a plurality of prosthetic leaflets attached to a frame; an attachment structure positioned within the valve prosthesis, the attachment structure attached to a first leaflet of the plurality of prosthetic leaflets and attached to a second leaflet of the plurality of prosthetic leaflets, the attachment structure configured to maintain the first leaflet in a fixed position relative to the second leaflet such that the plurality of prosthetic leaflets are offset from a first ostia and a second ostia; and a second valve prosthesis comprising a plurality of second prosthetic leaflets attached to a second frame, the second valve prosthesis positioned within the valve prosthesis and radially inward from the attachment structure.

2. The transcatheter valve apparatus of claim 1, wherein the attachment structure is configured to move between a first position, in which a first attachment portion of the attachment structure is spaced a first distance from a second attachment portion of the attachment structure such that an attachment opening is defined between the first attachment portion and the second attachment portion, and a second position, in which the first leaflet and the second leaflet are positioned within the attachment opening and the first attachment portion is spaced a second distance, which is less than the first distance, from the second attachment portion.

3. The transcatheter valve apparatus of claim 2, wherein the first attachment portion and the second attachment portion apply a compressive force to the first leaflet and the second leaflet when the first attachment portion and the second attachment portion are in the second position.

4. The transcatheter valve apparatus of claim 2, wherein the attachment structure comprises a nitinol material.

5. The transcatheter valve apparatus of claim 4, wherein the attachment structure is biased toward the second position.

6. The transcatheter valve apparatus of claim 2, further comprising a wire extending between the first attachment portion and the second attachment portion.

7. The transcatheter valve apparatus of claim 1, wherein the attachment structure passes through a first leaflet opening in the first leaflet and a second leaflet opening in the second leaflet.

8. A transcatheter valve apparatus comprising: a delivery assembly configured to deliver a valve prosthesis to a treatment site, the delivery assembly comprising: a capsule; and a placement structure comprising a first flexible arm and a second flexible arm, the first flexible arm and the second flexible arm configured to move between a first position, in which the first flexible arm and the second flexible arm are outside of the capsule and a first separating distance separates the first flexible arm from the second flexible arm, and a second position, in which the first flexible arm and the second flexible arm are retracted into the capsule and a second separating distance separates the first flexible arm from the second flexible arm, the second separating distance less than the first separating distance; an attachment structure removably attached to the placement structure, the attachment structure comprising: a first attachment portion removably attached to the first flexible arm; and a second attachment portion removably attached to the second flexible arm, wherein the first attachment portion is configured to be detached from the first flexible arm and the second attachment portion is configured to be detached from the second flexible arm such that the first attachment portion is in contact with a first leaflet portion of a first leaflet, and the second attachment portion is in contact with a second leaflet portion of a second leaflet, the first attachmentportion and the second attachment portion configured to maintain the first leaflet portion in a fixed position relative to the second leaflet portion such that the first leaflet portion and the second leaflet portion are offset from a first ostia and a second ostia.

9. The transcatheter valve apparatus of claim 8, wherein the first leaflet and the second leaflet comprise native leaflets of the native heart valve.

10. The transcatheter valve apparatus of claim 8, wherein the first leaflet and the second leaflet comprise prosthetic leaflets of a valve prosthesis.

11. The transcatheter valve apparatus of claim 8, wherein the attachment structure is configured to move between a first position, in which the first attachment portion is spaced a first distance from the second attachment portion such that an attachment opening is defined between the first attachment portion and the second attachment portion, and a second position, in which the first leaflet portion and the second leaflet portion are positioned within the attachment opening and the first attachment portion is spaced a second distance, which is less than the first distance, from the second attachment portion.

12. The transcatheter valve apparatus of claim 11, wherein the first attachment portion and the second attachment portion apply a compressive force to the first leaflet portion and the second leaflet portion when the first attachment portion and the second attachment portion are in the second position.

13. The transcatheter valve apparatus of claim 11, wherein the attachment structure comprises a nitinol material.

14. The transcatheter valve apparatus of claim 8, wherein the attachment structure comprises a wire extending between the first attachment portion and the second attachment portion.

15. The transcatheter valve apparatus of claim 8, wherein the attachment structure comprises an extension portion that extends outwardly from the first attachment portion and passes through a first leaflet opening in the first leaflet portion and a second leaflet opening in the second leaflet portion.

16. A method of providing access to one or more ostia, the method comprising: positioning a distal end of a delivery assembly at a treatment site; deploying, from the delivery assembly, an attachment structure at the treatment site such that the attachment structure is attached to a first leaflet and a second leaflet; and lacerating the first leaflet and the second leaflet to provide a passageway to a valve prosthesis, the attachment structure maintaining a first leaflet portion of the first leaflet in a fixed position relative to a second leaflet portion of the second leaflet such that the first leaflet and the second leaflet are offset from a first ostia and a second ostia.

17. The method of claim 16, wherein the first leaflet and the second leaflet comprise native leaflets of the native heart valve.

18. The method of claim 16, wherein the first leaflet and the second leaflet comprise prosthetic leaflets of a valve prosthesis.

19. The method of claim 16, wherein the attachment structure applies a compressive force to the first leaflet portion and the second leaflet portion.

20. The method of claim 16, wherein the attachment structure extends through a first leaflet opening in the first leaflet portion and a second leaflet opening in the second leaflet portion.

21. A method of providing anchoring for a valve prosthesis, the method comprising: positioning a distal end of a delivery assembly at a treatment site;deploying, from the delivery assembly, an attachment structure at the treatment site such that the attachment structure is attached to a first leaflet and a second leaflet that are adjacent to the treatment site; and delivering a valve prosthesis to the treatment site, the attachment structure maintaining a first leaflet portion of the first leaflet in a fixed position relative to a second leaflet portion of the second leaflet such that the first leaflet and the second leaflet remain attached to the attachment structure during expansion of the valve prosthesis at the treatment site.

22. The method of claim 21, wherein the first leaflet and the second leaflet comprise native, non-calcified leaflets of the native heart valve.

23. The method of claim 21, wherein the attachment structure applies a compressive force to the first leaflet portion and the second leaflet portion.

24. The method of claim 21, wherein the attachment structure extends through a first leaflet opening in the first leaflet portion and a second leaflet opening in the second leaflet portion.

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