WO2025217385A1 - Tissue perforation apparatus - Google Patents

Abstract

The present disclosure relates to tissue perforation devices and methods for use thereof. In an example, a tissue perforation apparatus comprises an outer shaft, an anchor device extending through the outer shaft, and a needle extending through the anchor device. The anchor device comprises an anchor head having a plurality of anchoring elements, wherein the anchor head is configured to move between a compacted state, in which the plurality of anchoring elements are retained inside the outer shaft, and a deployed state, in which exposed portions of the plurality of anchoring elements are bent radially outwards.

Description

TISSUE PERFORATION APPARATUS

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Application No. 63/632,939, filed April 11, 2024, which is incorporated by reference herein.

FIELD

[0002] The present disclosure relates to devices configured to form an opening in the target tissue, which can be a leaflet of an existing valvular structure.

BACKGROUND

[0003] The human heart can suffer from various valvular diseases. These valvular diseases can result in significant malfunctioning of the heart and ultimately require repair of the native valve or replacement of the native valve with an artificial valve. There are a number of known repair devices (for example, stents) and artificial valves, as well as a number of known methods of implanting these devices and valves in humans. Percutaneous and minimally-invasive surgical approaches, such as transcatheter aortic valve replacement (TAVR), are used in various procedures to deliver prosthetic medical devices to locations inside the body that are not readily accessible by surgery or where access without surgery is desirable.

[0004] Transcatheter aortic valve replacement (TAVR) is one example of a minimally-invasive surgical procedure used to replace a native aortic valve. In one specific example of the procedure, an expandable prosthetic heart valve is mounted in a crimped state on the distal end of a delivery apparatus and advanced through the patient's vasculature (for example, through a femoral artery and the aorta) to the heart. The prosthetic heart valve is positioned within the native valve and expanded to its functional size.

[0005] A variant of TAVR is valve-in- valve (ViV) TAVR, where a new prosthetic heart valve replaces a previously implanted prosthetic valve. In one specific example of the procedure, a new expandable prosthetic heart valve (“guest valve”) is delivered to the heart in a crimped state, as described above for the “native” TAVR. The guest valve is positioned within the previously implanted prosthetic valve (“host valve”) and then expanded to its functional size. The host valve in a ViV TAVR procedure can be a surgically implanted prosthetic valve or a transcatheter prosthetic valve. The term “host valve” is also used herein to refer to the native aortic valve in a native TAVR procedure. SUMMARY

[0006] Needles or other perforating tools can be utilized for piercing existing leaflets to form an opening that modifies the existing valvular structure, after which a guest prosthetic valve can be implanted in the modified valvular structure, mitigating the risk of coronary ostial obstruction. The leaflet is a relatively thin tissue having a free edge opposite to attachment on an opposite end to the aortic wall in the case of a native leaflet of an aortic valve, or to a frame of a previously implanted prosthetic valve in the case of ViV procedures. Perforation of the leaflet by pushing a needle or other perforating tool there-against, can move the leaflet to some extent due to the push force applied thereto. Even if the needle or other tool does puncture eventually through the tissue material, such initial movement can lead to the penetration point being in a different region of the leaflet relative to the initial point of contact.

[0007] In one of its basic configurations, a tissue perforation apparatus comprises an outer shaft and an anchor device comprising a plurality of anchoring elements. This basic configuration can preferably be provided with any one or more of the features described elsewhere herein, in particular with those of the examples described hereafter. However, it should be understood that the basic configuration can preferably also be provided with any one or more of the features shown in the figures and/or described in conjunction with the figures, either in addition to or alternatively to the features of the examples described hereafter.

[0008] In some examples, the anchor device can optionally extend through the outer shaft.

[0009] In some examples, the anchor device can optionally be axially movable relative to the outer shaft.

[0010] In some examples, the anchor device comprises an anchor head comprising the plurality of anchoring elements.

[0011] In some examples, the tissue perforation apparatus can comprise a needle that can optionally extend through the anchor device.

[0012] In some examples, the needle can optionally be axially movable relative to the anchor device.

[0013] In some examples, the anchor head can be optionally configured to move between a compacted state, in which the plurality of anchoring elements are retained inside the outer shaft, and a deployed state, in which exposed portions of the plurality of anchoring elements are bent radially outwards.

[0014] In some examples, the plurality of anchoring elements can optionally be curled backwards in the deployed state. [0015] In some examples, each of the anchoring elements optionally terminates at an anchoring tip.

[0016] In some examples, a diameter defined by the anchoring tips in the deployed state can optionally be greater than a diameter defined by the anchoring tips in the compacted state.

[0017] In some examples, each anchoring element can optionally comprise an anchoring element body optionally extending between an anchoring element base and the corresponding anchoring tip.

[0018] In some examples, the anchoring element body can optionally be straight in the compacted state.

[0019] In some examples, the anchoring element body can optionally be curled in the deployed state.

[0020] In some examples, the anchor head can optionally be shape-set to assume the deployed state when the anchoring elements are exposed out of the outer shaft.

[0021] In some examples, the apparatus comprises a dilation assembly optionally extending through the anchor device, the dilation assembly optionally comprising an expansion member movable between a compacted state and an expanded state.

[0022] In some examples, the needle can optionally extend through the dilation assembly.

[0023] In some examples, the apparatus can comprise a protective shaft optionally disposed between the anchor device and the dilation assembly.

[0024] In some examples, the needle can optionally be configured to form a pilot puncture in a target tissue.

[0025] In some examples, the anchoring elements can optionally be configured to penetrate through the target tissue.

[0026] In some examples, the anchoring elements can optionally be configured to anchor the anchor head to the target tissue in the deployed state.

[0027] In one of its basic methods, a method comprises advancing a tissue perforation apparatus to a target tissue over a guidewire. This basic method can preferably be provided with any one or more of the steps described elsewhere herein, in particular with those of the examples described hereafter. However, it should be understood that the basic method can preferably also be provided with any one or more of the steps shown in the figures and/or described in conjunction with the figures, either in addition to or alternatively to the steps of the examples described hereafter.

[0028] In some examples, the tissue perforation apparatus optionally comprises an anchor device. [0029] In some examples, the anchor device can optionally extend through an outer shaft.

[0030] In some examples, the tissue perforation apparatus optionally comprises a needle that can optionally extend through the anchor device.

[0031] In some examples, the needle can optionally extend through the anchor device.

[0032] In some examples, the method comprises approximating a distal end of the outer shaft to the target tissue.

[0033] In some examples, the method comprises anchoring an anchor head of the anchor device to the target tissue, optionally by distally advancing the anchor head relative to the outer shaft, thereby causing anchoring elements of the anchor head to penetrate through the target tissue.

[0034] In some examples, the method comprises forming a pilot puncture through the target tissue, optionally by advancing a needle head of the needle against the target tissue.

[0035] In some examples, the anchoring the anchor head optionally comprises exposing a length of the anchoring elements that optionally allows the anchoring elements to curl backwards.

[0036] In some examples, the method optionally comprises, after the forming the pilot puncture, advancing a dilation assembly towards the pilot puncture.

[0037] In some examples, the dilation assembly optionally comprises an expansion member optionally configured to transition between a compacted state and an expanded state thereof.

[0038] In some examples, the advancing the dilation assembly optionally comprises positioning the expansion member, in its compacted state, within the pilot puncture.

[0039] In some examples, the method optionally comprises, after the positioning the expansion member inside the pilot puncture, expanding the expansion member inside the pilot puncture to dilate the pilot puncture and optionally form a tissue opening within the target tissue.

[0040] In some examples, the method optionally comprises, after the expanding the expansion member, compressing the expansion member.

[0041] In some examples, the method optionally comprises, after the forming the pilot puncture, releasing the anchor head from the target tissue.

[0042] In some examples, the method optionally comprises, after the compressing the expansion member, retracting the expansion member from the target tissue.

[0043] In some examples, the target tissue can optionally be a host leaflet of a host valvular structure, wherein the tissue opening is a leaflet opening. [0044] In some examples, the method optionally comprises, after the retracting the expansion member, positioning a guest prosthetic valve in a radially compressed state thereof within the host valvular structure, and optionally radially expanding the guest prosthetic valve.

[0045] The aspects of this disclosure can be used in combination or separately. This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the detailed description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. The foregoing and other objects, features, and advantages of the invention will become more apparent from the following detailed description, which proceeds with reference to the accompanying figures.

BRIEF DESCRIPTION OF THE FIGURES

[0046] Some examples of the invention are described herein with reference to the accompanying figures. The description, together with the figures, makes apparent to a person having ordinary skill in the art how some examples may be practiced. The figures are for the purpose of illustrative description and no attempt is made to show structural details of an example in more detail than is necessary for a fundamental understanding of the invention. For the sake of clarity, some objects depicted in the figures are not to scale.

In the Figures:

[0047] Fig. 1 is a sectional view of an aortic root.

[0048] Fig. 2A shows a cross-sectional view of a prosthetic heart valve implanted in the native aortic valve of within the aortic root of Fig. 1, according to an example.

[0049] Fig. 2B shows the implanted prosthetic heart valve of Fig. 1A as viewed from the ascending aorta, according to an example.

[0050] Fig. 3 shows a valve-in- valve implantation within the native aortic valve of Fig. 1, according to an example.

[0051] Fig. 4 illustrates an exemplary tissue perforation apparatus that includes an anchor device and a needle.

[0052] Fig. 5 shows a perspective sectional view of a distal portion of an exemplary tissue perforation apparatus.

[0053] Figs. 6A-6C show a distal portion the anchor device in different states of deployment relative to an outer shaft through which it extends.

[0054] Fig. 6D shows the distal portion of the anchor device of Figs. 6A-6C anchored to a target tissue. [0055] Fig. 7 shows an exemplary tissue modification system, comprising a steerable delivery apparatus and the tissue perforation apparatus extending therethrough.

[0056] Figs. 8A-8G illustrate steps in a method for utilizing a tissue perforation apparatus for forming a leaflet opening within a host leaflet.

[0057] Fig. 9A shows an exemplary dilation apparatus of the system extending through the steerable delivery apparatus.

[0058] Fig. 9B shows an exemplary dilation apparatus of the system extending through a delivery catheter that extends through the steerable delivery apparatus.

[0059] Figs. 10A-10E illustrate exemplary steps in a method for forming a leaflet opening.

[0060] Fig. 10F is a simplified side view of a guest prosthetic valve in a crimped configuration positioned inside the leaflet opening formed in the existing valvular structure.

[0061] Fig. 10G is a simplified side view of the guest prosthetic valve of Fig. 10F expanded inside the existing valvular structure.

[0062] Fig. 11A shows the hole-dilation balloon positioned within a pilot puncture of the host leaflet in a deflated state.

[0063] Fig. 1 IB shows the hole-dilation balloon of Fig. 11A inflated within the host leaflet.

[0064] Fig. 11C shows the guest prosthetic valve positioned in the leaflet opening after removal of the hole-dilating balloon of Fig. 1 IB.

[0065] Fig. 12A is a perspective view of a host prosthetic valve subsequent to forming a leaflet opening thereof.

[0066] Fig. 12B is a perspective view of a guest prosthetic valve expanded within a leaflet opening of a host prosthetic valve.

[0067] Fig. 13A shows a perspective sectional view of a distal portion of an exemplary tissue perforation apparatus that include a dilation assembly.

[0068] Fig. 13B is a cross-sectional side view of the apparatus of Fig. 13A.

[0069] Figs. 14A-14K illustrate steps in a method for utilizing the tissue perforation apparatus of Fig. 13A-13B for forming a leaflet opening within a host leaflet.

DETAILED DESCRIPTION

[0070] For purposes of this description, certain aspects, advantages, and novel features of the examples of this disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as being limiting in any way. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed examples, alone and in various combinations and sub-combinations with one another. The methods, apparatus, and systems are not limited to any specific aspect or feature or combination thereof, nor do the disclosed examples require that any one or more specific advantages be present, or problems be solved. The technologies from any example can be combined with the technologies described in any one or more of the other examples. In view of the many possible examples to which the principles of the disclosed technology may be applied, it should be recognized that the illustrated examples are only preferred examples and should not be taken as limiting the scope of the disclosed technology.

[0071] Although the operations of some of the disclosed examples are described in a particular, sequential order for convenient presentation, it should be understood that this manner of description encompasses rearrangement, unless a particular ordering is required by specific language set forth below. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed methods can be used in conjunction with other methods. Additionally, the description sometimes uses terms like “provide” or “achieve” to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations that correspond to these terms may vary depending on the particular implementation and are readily discernible by one of ordinary skill in the art.

[0072] All features described herein are independent of one another and, except where structurally impossible, can be used in combination with any other feature described herein.

[0073] As used in this application and in the claims, the singular forms “a”, “an”, and “the” include the plural forms unless the context clearly dictates otherwise. Additionally, the terms “have” or “includes” means “comprises”. Further, the terms “coupled”, “connected”, and “attached”, as used herein, are interchangeable and generally mean physically, mechanically, chemically, magnetically, and/or electrically coupled or linked and does not exclude the presence of intermediate elements between the coupled or associated items absent specific contrary language. As used herein, “and/or” means “and” or “or”, as well as “and” and “or”.

[0074] Directions and other relative references may be used to facilitate discussion of the drawings and principles herein, but are not intended to be limiting. For example, certain terms may be used such as “inner”, “outer”, “upper”, “lower”, “inside”, “outside”, “top”, “bottom”, “interior”, “exterior”, “left”, right”, and the like. Such terms are used, where applicable, to provide some clarity of description when dealing with relative relationships, particularly with respect to the illustrated examples. Such terms are not, however, intended to imply absolute relationships, positions, and/or orientations. For example, with respect to an object, an “upper” part can become a “lower” part simply by turning the object over. Nevertheless, it is still the same part and the object remains the same.

[0075] The term “plurality” or “plural” when used together with an element means two or more of the element. Directions and other relative references (for example, inner and outer, upper and lower, above and below, left and right, and proximal and distal) may be used to facilitate discussion of the drawings and principles herein but are not intended to be limiting.

[0076] The terms “proximal” and “distal” are defined relative to the use position of a delivery apparatus. In general, the end of the delivery apparatus closest to the user of the apparatus is the proximal end, and the end of the delivery apparatus farthest from the user (for example, the end that is inserted into a patient's body) is the distal end. The term “proximal” when used with two spatially separated positions or parts of an object can be understood to mean closer to or oriented towards the proximal end of the delivery apparatus. The term “distal” when used with two spatially separated positions or parts of an object can be understood to mean closer to or oriented towards the distal end of the delivery apparatus. The terms “longitudinal” and “axial” are interchangeable, and refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined.

[0077] The terms “axial direction”, “radial direction”, and “circumferential direction” have been used herein to describe the arrangement and assembly of components relative to the geometry of the frame of the prosthetic valve, or the geometry of an inflatable balloon that can be used to expand a prosthetic valve. Such terms have been used for convenient description, but the disclosed examples are not strictly limited to the description. In particular, where a component or action is described relative to a particular direction, directions parallel to the specified direction as well as minor deviations therefrom are included. Thus, a description of a component extending along an axial direction of an apparatus disclosed herein or a shaft thereof does not require the component to be aligned with a center of the shaft; rather, the component can extend substantially along a direction parallel to a central axis of the apparatus or a shaft thereof.

[0078] As used herein, the terms “integrally formed” and “unitary” refer to a construction that does not include any welds, fasteners, or other means for securing separately formed pieces of material to each other.

[0079] As used herein, operations that occur “simultaneously” or “concurrently” occur generally at the same time as one another, although delays in the occurrence of operation relative to the other due to, for example, spacing between components, are expressly within the scope of the above terms, absent specific contrary language. [0080] As used herein, terms such as “first”, “second”, and the like are intended to serve as respective labels of distinct components, steps, etc. and are not intended to connote or imply a specific sequence or priority. For example, unless otherwise stated, a step of performing a second action and/or of forming a second component may be performed prior to a step of performing a first action and/or of forming a first component.

[0081] As used herein, the term “substantially” means the listed value and/or property and any value and/or property that is at least 75% of the listed value and/or property. Equivalently, the term “substantially” means the listed value and/or property and any value and/or property that differs from the listed value and/or property by at most 25%. For example, “at least substantially parallel” refers to directions that are fully parallel, and to directions that diverge by up to 22.5 degrees.

[0082] In the present disclosure, a reference numeral that includes an alphabetic label (for example, “a”, “b”, “c”, etc.) is to be understood as labeling a particular example of the structure or component corresponding to the reference numeral. Accordingly, it is to be understood that components sharing like names and/or like reference numerals (for example, with different alphabetic labels or without alphabetic labels) may share any properties and/or characteristics as disclosed herein even when certain such components are not specifically described and/or addressed herein.

[0083] Throughout the figures of the drawings, different superscripts for the same reference numerals are used to denote different examples of the same elements. Examples of the disclosed devices and systems may include any combination of different examples of the same elements. Specifically, any reference to an element without a superscript may refer to any alternative example of the same element denoted with a superscript. In order to avoid undue clutter from having too many reference numbers and lead lines on a particular drawing, some components will be introduced via one or more drawings and not explicitly identified in every subsequent drawing that contains that component.

[0084] Described herein are devices and methods for implanting prosthetic valves and modifying leaflets of an existing valvular structure in a patient’s heart. Prior to or during implantation of the prosthetic heart valve within the existing valvular structure, each device, such as a delivery apparatus that can optionally carry a prosthetic valve, can be provided in the ascending aorta of a patient and can be used to pierce, lacerate, slice, tear, cut or otherwise modify a leaflet or commissure of the existing valvular structure. In some examples, the existing valvular structure can be a native aortic valve (for example, normal or abnormal, such as bicuspid aortic valve (BAV)) or a prosthetic valve previously implanted in the native aortic valve. The modification can avoid, or at least reduce the likelihood of, issues that leaflets of the existing valvular structure might otherwise cause once the prosthetic heart valve has been fully installed, for example, obstruction of blood flow to the coronary arteries, improper mounting due to a non-circular valve cross-section, and/or restricted access to the coronary arteries if subsequent intervention is required. While described with respect to aortic valve, it should be understood that the disclosed examples can be adapted to deliver devices that can modify existing valvular structure, and in some implementations, implant prosthetic devices, to and/or in any of the native annuluses of the heart (for example, the aortic, pulmonary, mitral, and tricuspid annuluses), and can be used with any of various delivery approaches (for example, retrograde, antegrade, transseptal, transventricular, transatrial, etc.).

[0085] Fig. 1 illustrates an anatomy of the aortic root 22, which is positioned between the left ventricle 32 and the ascending aorta 26. The aortic root 22 includes a native aortic valve 20 having a native valvular structure 29 comprising a plurality of native leaflets 30. Normally, the native aortic valve 20 has three leaflets (only two leaflets are visible in the simplified illustration of Fig. 1), but aortic valves with fewer than three leaflets are possible. The leaflets 30 are supported at native commissures by the aortic annulus 24, which is a ring of fibrous tissue at the transition point between the left ventricle 32 and the aortic root 22. The leaflets 30 can cycle between open and closed positions (the closed position is shown in Fig. 1) to regulate flow of blood from the left ventricle 32 to the ascending aorta 26. Branching off the aortic root 22 are the coronary arteries 34, 36. The coronary artery ostia 42, 44 are the openings that connect the aortic root 22 to the coronary arteries 34, 36.

[0086] Figs. 2A-2B show an exemplary prosthetic valve 100 that can be implanted in a native heart valve, such as the native aortic valve 20 of Fig. 1. The term “prosthetic valve”, as used herein, refers to any type of a prosthetic valve deliverable to a patient's target site over a catheter, which is radially expandable and compressible between a radially compressed, or crimped, state, and a radially expanded state. Thus, the prosthetic valve can be crimped on or retained by an implant delivery apparatus (not shown) in the radially compressed state during delivery, and then expanded to the radially expanded state once the prosthetic valve reaches the implantation site. The expanded state may include a range of diameters to which the valve may expand, between the compressed state and a maximal diameter reached at a fully expanded state. Thus, a plurality of partially expanded states may relate to any expansion diameter between radially compressed or crimped state, and maximally expanded state. A prosthetic valve of the current disclosure (for example, prosthetic valve 100) may include any prosthetic valve configured to be mounted within the native aortic valve, the native mitral valve, the native pulmonary valve, and the native tricuspid valve.

[0087] It is understood that the prosthetic valves disclosed herein may be used with a variety of implant delivery apparatuses. Balloon expandable valves generally involve a procedure of inflating a balloon within a prosthetic valve, thereby expanding the prosthetic valve within the desired implantation site. Once the valve is sufficiently expanded, the balloon is deflated and retrieved along with a delivery apparatus (not shown). Self-expandable valves include a frame that is shape-set to automatically expand as soon an outer retaining shaft or capsule (not shown) is withdrawn proximally relative to the prosthetic valve. Mechanically expandable valves are a category of prosthetic valves that rely on a mechanical actuation mechanism for expansion. The mechanical actuation mechanism usually includes a plurality of expansion and locking assemblies (such as the prosthetic valves described in U.S. Patent No. 10,603,165, International Application No. PCT/US2021/052745 and U.S. Provisional Application Nos. 63/85,947 and 63/209904, each of which is incorporated herein by reference in its entirety), releasably coupled to respective actuation assemblies of a delivery apparatus, controlled via a handle (not shown) for actuating the expansion and locking assemblies to expand the prosthetic valve to a desired diameter. The expansion and locking assemblies may optionally lock the valve's diameter to prevent undesired recompression thereof, and disconnection of the actuation assemblies from the expansion and locking assemblies, to enable retrieval of the delivery apparatus once the prosthetic valve is properly positioned at the desired site of implantation.

[0088] Figs. 2A-2B show an example of a prosthetic valve 100, which can be a balloon expandable valve or any other type of valve, illustrated in an expanded state. The prosthetic valve 100 can comprise an outflow end 106 and an inflow end 104. In some instances, the outflow end 106 is the proximal end of the prosthetic valve 100, and the inflow end 104 is the distal end of the prosthetic valve 100. Alternatively, depending for example on the delivery approach of the valve, the outflow end can be the distal end of the prosthetic valve, and the inflow end can be the proximal end of the prosthetic valve.

[0089] The term “outflow”, as used herein, refers to a region of the prosthetic valve through which the blood flows through and out of the prosthetic valve 100.

[0090] The term “inflow”, as used herein, refers to a region of the prosthetic valve through which the blood flows into the prosthetic valve 100.

[0091] In the context of the present application, the terms “lower” and “upper” are used interchangeably with the terms “inflow” and “outflow”, respectively. Thus, for example, the lower end of the prosthetic valve is its inflow end and the upper end of the prosthetic valve is its outflow end.

[0092] In the context of the present application, the terms “lower” and “upper” are used interchangeably with the terms “distal to” and “proximal to”, respectively. Thus, for example, a lowermost component can refer to a distal-most component, and an uppermost component can similarly refer to a proximal-most component.

[0093] The terms “longitudinal” and “axial”, as used herein, refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined.

[0094] The prosthetic valve 100 comprises an annular frame 102 movable between a radially compressed configuration and a radially expanded configuration, and a valvular structure 113 that comprises prosthetic valve leaflets 114 mounted within the frame 102. The frame 102 can be made of various suitable materials, including plastically-deformable materials such as, but not limited to, stainless steel, a nickel-based alloy (for example, a nickel-cobalt-chromium alloy such as MP35N alloy), polymers, or combinations thereof. When constructed of a plastically- deformable materials, the frame 102 can be crimped to a radially compressed state on a balloon catheter, and then expanded inside a patient by an inflatable balloon or equivalent expansion mechanism. Alternatively or additionally, the frame 102 can be made of shape-memory materials such as, but not limited to, nickel-titanium alloy (for example, Nitinol). When constructed of a shape-memory material, the frame 102 can be crimped to a radially compressed state and restrained in the compressed state by insertion into a shaft or equivalent mechanism of a delivery apparatus.

[0095] In the example illustrated in Figs. 2A-2B, the frame 102 is an annular, stent-like structure comprising a plurality of intersecting struts 108. In this application, the term “strut” encompasses axial struts, angled struts, laterally extendable struts, commissure windows, commissure support struts, support posts, and any similar structures described by U.S. Pat. Nos. 7,993,394 and 9,393,110, which are incorporated herein by reference. A strut 108 may be any elongated member or portion of the frame 102. The frame 102 can include a plurality of strut rungs that can collectively define one or more rows of cells 110. The frame 102 can have a cylindrical or substantially cylindrical shape having a constant diameter from the inflow end 104 to the outflow end 106 as shown, or the frame can vary in diameter along the height of the frame, as disclosed in US Pat. No. 9,155,619, which is incorporated herein by reference.

[0096] The struts 108 can include a plurality of angled struts and vertical or axial struts. At least some of the struts 108 can be pivotable or bendable relative to each other, so as to permit frame expansion or compression. For example, the frame 102 can be formed from a single piece of material, such as a metal tube, via various processes such as, but not limited to, laser cutting, electroforming, and/or physical vapor deposition, while retaining the ability to collapse/expand radially in the absence of hinges and like.

[0097] A valvular structure 113 of the prosthetic valve 100 can include a plurality of prosthetic valve leaflets 114 (for example, three leaflets), positioned at least partially within the frame 102, and configured to regulate flow of blood through the prosthetic valve 100 from the inflow end 104 to the outflow end 106. While three leaflets 114 arranged to collapse in a tricuspid arrangement, are shown in the example illustrated in Figs. 2A-2B, it will be clear that a prosthetic valve 100 can include any other number of leaflets 114. Adjacent leaflets 114 can be arranged together to form prosthetic valve commissures 116 that are coupled (directly or indirectly) to respective portions of the frame 102, thereby securing at least a portion of the valvular structure 113 to the frame 102. The prosthetic valve leaflets 114 can be made from, in whole or part, biological material (for example, pericardium), bio-compatible synthetic materials, or other such materials. Further details regarding transcatheter prosthetic valves, including the manner in which leaflets 114 can be coupled to the frame 102 of the prosthetic valve 100, can be found, for example, in U.S. Patent Nos. 6,730,118, 7,393,360, 7,510,575, 7,993,394, 8,652,202, and 11,135,56, all of which are incorporated herein by reference in their entireties.

[0098] In some examples, the prosthetic valve 100 can comprise at least one skirt or sealing member. For example, the prosthetic valve 100 can include an inner skirt (not shown in Fig. 2A-2B), which can be secured to the inner surface of the frame 102. Such an inner skirt can be configured to function, for example, as a sealing member to prevent or decrease perivalvular leakage. An inner skirt can further function as an anchoring region for leaflets 114 to the frame 102, and/or function to protect the leaflets 114 against damage which may be caused by contact with the frame 102, for example during valve crimping or during working cycles of the prosthetic valve 100. An inner skirt can be disposed around and attached to the inner surface of frame 102, while the leaflets can be sutured to the inner skirt along a scalloped line (not shown). An inner skirt can be coupled to the frame 102 via sutures or another form of coupler. [0099] The prosthetic valve 100 can comprise, in some examples, an outer skirt 118 mounted on the outer surface of frame 102 (as shown in Figs. 2A-2B), configured to function, for example, as a sealing member retained between the frame 102 and the surrounding tissue of the native annulus against which the prosthetic valve is mounted, or against an inner side of a previously implanted valve in the case of ViV procedures (described further below), thereby reducing risk of paravalvular leakage (PVL) past the prosthetic valve 100. The outer skirt 118 can be coupled to the frame 102 via sutures or another form of coupler.

[0100] Any of the inner skirt and/or outer skirt can be made of various suitable biocompatible materials, such as, but not limited to, various synthetic materials (for example, PET) or natural tissue (for example pericardial tissue). In some cases, the inner skirt can be formed of a single sheet of material that extends continuously around the inner surface of frame 102. In some cases, the outer skirt 118 can be formed of a single sheet of material that extends continuously around the outer surface of frame 102.

[0101] The cells 110, defined by interconnected struts 108, define cell openings 112. While some of the cell openings 112 can be covered by the inner skirt and/or the outer skirt, at least a portion of the cell opening 112 can remain uncovered, such as cell openings 112 which are closer to the outflow end 106 of the prosthetic valve.

[0102] Figs. 2A-2B illustrate a hypothetical coronary artery obstruction that could occur in some cases from implantation of a prosthetic valve 100 within the native aortic valve 20. In this example, the prosthetic valve 100 is the guest valve or new valve, and the native aortic valve 20 is the host valve or old valve.

[0103] During implantation of the prosthetic valve 100, the prosthetic valve 100 is positioned within a central region defined between the native leaflets 30, which are also the host leaflets 10 for the example illustrated in Fig. 2A-2B. The prosthetic valve 100 is then radially expanded against the host leaflets 10. As illustrated, the host leaflets 10 form a tube around the frame 102 of the prosthetic valve 100 after the prosthetic valve 100 is radially expanded to the working diameter. As further illustrated, expansion of the prosthetic valve 100 displaces the host leaflets 10 outwards towards the coronary ostia 42, 44 such that the host leaflets 10 contact a portion of the aortic root 22 surrounding the coronary ostia 42, 44, causing coronary artery obstruction. [0104] For an existing implanted prosthetic valve, the valvular structure may naturally degrade over time thereby requiring repair or replacement in order to maintain adequate heart functions. In a Valve- in- Valve (ViV) procedure, a new prosthetic heart valve is mounted within the existing, degrading prosthetic heart valve in order to restore proper function. Fig. 3 illustrates an exemplary hypothetical coronary artery obstruction that could occur in some cases from implantation of a prosthetic valve 100b within a previously implanted prosthetic valve 100a (for example, after a ViV procedure). In this example, the prosthetic valve 100b is the guest valve or new valve, and the prosthetic valve 100a is the host valve or old valve. In this example, the prosthetic valve 100a was previously implanted within the orifice of the native aortic valve 20. Each of the prosthetic valves 100a, 100b can have the general structure of the prosthetic valve 100 described with reference to Figs. 2A-2B, though in some examples, each of the prosthetic valves 100a, 100b can be a different type of prosthetic valve. For example, a balloon expandable guest valve 100b can be implanted inside a previously implanted mechanically expandable or self-expandable host valve 100a.

[0105] During implantation of the prosthetic valve 100b, the prosthetic valve 100b is positioned within a central region defined between the leaflets 114a of the prosthetic valve 100a, which now take the role of host leaflet 10. The prosthetic valve 100b is then radially expanded against the host leaflets 10 (i.e., against the prosthetic valve leaflets 1 14c). As illustrated, the radial expansion of the prosthetic valve 100a results in outward displacement of the host leaflets 10. As further illustrated, the host leaflets 10 are displaced such that the host leaflets 10 contact the aortic root 22 at positions superior to the coronary artery ostia 42, 44, causing coronary artery ostia obstruction. Alternatively, the guest prosthetic valve 100b can displace the host leaflets 114a outwardly against the frame 102a of the host valve 100a, thereby blocking the flow of blood through the frame 102a to the coronary ostia 42, 44.

[0106] In some patient anatomies (for example, when the outflow end 106 of the prosthetic valve 100 is at the STJ level 28 and the diameter of the prosthetic valve 100 is similar to the STJ diameter such that the frame 102 touches or is very close to the aortic wall 38 at the STJ level 28), the host leaflets 10 may compromise the ability for future access into the coronary arteries 34, 36 or perfusion through the frame 102 to the coronary arteries 34, 36 during the diastole phase of the cardiac cycle. Similar problems may occur in some patient anatomies either when a guest prosthetic valve 100b is percutaneously expanded within a previously implanted host prosthetic valve 100a, or when a prosthetic valve 100 is percutaneously expanded within a native valve, displacing the native leaflets 30 outward toward the coronary ostia 42, 44.

[0107] The risk illustrated in Fig. 3 may be higher when the host valve is a bioprosthetic valve without a frame or when the leaflets of the host valve are external to a frame. Risk of coronary artery ostia obstruction can increase in a cramped aortic root or when the coronary artery ostium sits low. In the examples illustrated in Figs. 2A-3, the host leaflets 10 are shown obstructing both coronary artery ostia 42, 44. In some cases, only one host leaflet 10 may obstruct a respective coronary artery ostium. For example, the risk of obstructing the left coronary ostium 42 tends to be greater than obstructing the right coronary ostium 44 because the left coronary ostium 42 typically sits lower than the right coronary ostium 44.

[0108] The term “host valve” as used herein refers to a native heart valve in which a prosthetic valve is implanted or a previously implanted prosthetic valve in which a new prosthetic valve is implanted. Moreover, in any of the examples disclosed herein, when the host valve is a previously implanted prosthetic valve, the host valve can be a surgically implanted prosthetic heart valve (known as a “surgical valve”) or a transcatheter heart valve. The term “guest valve”, as used herein, refers to a prosthetic valve implanted in a host valve, which can be either a native heart valve or a previously implanted prosthetic valve. Similarly, the term “host leaflets 10”, as used herein, refers to native leaflets 30 of a native valve in which a new guest prosthetic valve 100 is implanted, or to prosthetic valve leaflets 114a of a previously implanted host valve 100a in which a new guest prosthetic valve 100b is implanted.

[0109] When a guest prosthetic valve 100 is deployed inside a host valvular structure 12, it displaces the host leaflets 10 of the host valve radially outwards, towards and against a host interior surface 14, which can be the interior surface of the aortic wall 38 if the host valve is the native valve, or an interior surface of the frame 102a of a previously implanted prosthetic valve 100a serving as the host valve.

[0110] To avoid obstruction of blood flow to the coronary arteries 34, 36, the valvular structure 12 of the existing host valve (whether a native aortic valve or a previously implanted prosthetic valve) can be modified by components of a delivery apparatus prior to or during implantation of a new prosthetic valve within the existing valvular structure 12. In some examples, the host valvular structure 12 is modified by piercing, lacerating, tearing, slicing, and/or cutting one or more host leaflets 10 (for example, a free end of the host leaflet 10 or a commissure of adjacent host leaflets 10, which can be a native commissure 40 for a native aortic valve 20, or a prosthetic valve commissure 116 for a previously implanted host prosthetic valve 100) using the delivery apparatus. The modification thus disrupts the impermeable tubular structure that would otherwise be formed by the existing host leaflets 10, thereby allowing blood to flow to the coronary arteries 34, 36.

[0111] Fig. 4 illustrates an exemplary stabilized tissue perforation apparatus 200, which can include a delivery catheter 206 attached to a handle 202 and extending distally therefrom. Fig. 5 shows a perspective sectional view of a distal portion of the tissue perforation apparatus of Fig. 4. The delivery catheter 206 defines a delivery catheter lumen 208 and can have a delivery catheter distal portion 210 which can be, in some examples, an atraumatic distal end 210, such as by being rounded and/or being curved radially inwards, or otherwise formed to include an outer surface tapering in the distal direction. The terms “stabilized tissue perforation apparatus 200”, “tissue perforation apparatus 200”, and “apparatus 200”, as used herein, are interchangeable. [0112] The tissue perforation apparatus 200 can include a hollow needle 212 and an anchor device 230 through which the needle 212 can extend. The needle 212 comprises a needle head 216 and a needle shaft 222 extending proximally from the needle head 216, collectively defining a needle lumen 214. The needle head 216 is configured to pierce a target tissue, such as a host leaflet 10 of a host valvular structure 12, to form a pilot puncture 50 in the host leaflet 10. The needle head 216 can define an angled surface 218 terminating at a sharp needle tip 220 configured to facilitate piercing the host leaflet 10 when the needle 212 is pressed thereagainst. [0113] In some examples, at least a portion of the needle shaft 222 comprises slits arranged in a desired pattern, such as that of known hypo-tubes, to enhance flexibility thereof. In the example illustrated in Figs. 4-5, at least part of the needle shaft 222, such as a distal portion 224 thereof, is shown to include a plurality of circumferential slits 226 axially spaced from each other, so as to form circumferential bands separating between adjacent circumferential slits 226, with axially extending connecting portions connecting adjacent bands. Two adjacent circumferential bands can be connected by a plurality of angularly spaced connecting portions defined between ends of corresponding circumferential slits 226. In such arrangements, the slitted part of the needle shaft 222, such as the distal portion 224, exhibits sufficient flexibility to allow it to flex as it is pushed through a tortuous pathway without kinking or buckling, and/or to bend when passed through bent portions of the vasculature and/or through bends of a catheter is extends through.

[0114] While a specific pattern is illustrated in Figs. 4-5, which can be a laser cut pattern, it is to be understood that the pattern of slits 226 and/or the size of the slits 226 and/or axial distances between the slits 226 can vary along the length of the corresponding slitted part of the needle shaft 222 in order to vary stiffness of the slitted part of the needle shaft 222 along its length. For example, the axial distance between adjacent slits 226 can decrease from the proximal end to the distal end of the slitted part of the needle shaft 222 to provide greater stiffness near the proximal end and greater flexibility near the distal end of the needle shaft 222.

[0115] In some examples, the slitted part of the needle shaft 222 can extend along the entire length of the needle shaft 222 or at least a significant portion of a length thereof. In some examples, the needle shaft 222 can include a distal portion 224 that includes slits, such as slits 226, and a proximal portion 228 extending proximally from the distal portion 224, which can be devoid of slits, as illustrated in Fig. 5. In some examples, the distal portion 224 and the proximal portion 228 of the needle shaft 222 are separate components that can be affixed to each other, and may be made from similar or different materials. For example, a laser-cut metallic tube that includes slits 226 can be used to form the distal portion 224, while the proximal portion 228 can be made of a polymeric material. The distal portion 224 can allow for increased flexibility along a distal part of the needle 212, allowing it to be steered towards a target tissue, such as a host leaflet 10, to improve precision of positioning and penetration, while the polymeric proximal portion 228, devoid of such slits, may be less flexible than the distal portion 224, yet flexible enough to allow it to passively bend along curved portions of the patient's vasculature, for example.

[0116] In some examples, the distal portion 224 extends along less than 50% of the length of the entire needle shaft 222. In some examples, the distal portion 224 extends along less than 30% of the length of the entire needle shaft 222. In some examples, the distal portion 224 extends along less than 25% of the length of the entire needle shaft 222. In some examples, the distal portion 224 extends along less than 20% of the length of the entire needle shaft 222. In some examples, the needle head 216 can be continuous with and/or integrally formed with the distal portion 224. For example, when the distal portion 224 is formed from a metallic tube, the needle head 216 can be an integral extension of the tube, together forming a unitary component, while the needle head 216 can be devoid of slits.

[0117] In some implementations of a needle 212, the length of the needle shaft 222 extending through a patient's vasculature, all the way to a host leaflet 10, such as a leaflet in an aortic valve, can be in the order of more than 2 meters, such as between 2-3 meters or even longer. Laser cutting metallic tubes have such lengths can be costly. Limiting the distal portion 224 of the needle shaft 222 to be formed as a hypotube, while the optionally longer proximal portion 228 is made of a polymeric material, can advantageously reduce manufacturing costs. The proximal portion 228 can be affixed, at its distal end, to a proximal end of the distal portion 224, by any method known in the art such as gluing, overmolding, and the like.

[0118] While the needle shaft 222 is shown in the example illustrated in Fig. 5 to be formed of a distal portion 224 that includes slits 226, and a proximal portion 228 devoid of slits, it is to be understood any exemplary needle 212 disclosed herein can be, in some examples, slitted along its entire length, such as by being made of a metallic laser-cut hypotube that defines the entirety of the needle shaft 222.

[0119] The anchor device 230 of apparatus 200 includes an anchor head 236 which can be continuous with, or attached, directly or via one or more intermediate components, to an anchor shaft 232. The anchor head 236 and anchor shaft 232 collectively define an anchor lumen 234 through which the needle 212 can extend. The anchor head 236 includes a plurality of anchoring elements 238 configured to engage with or otherwise grasp a target tissue, such as a host leaflet 10 of a host valvular structure 12. In some examples, the anchoring elements 238 are spikes that can engage the target tissue by, for example, piercing through the target tissue. The anchor head 236 can move between a compacted state, in which the anchoring elements 238 are maintained in a relatively axially-extending configuration inside an outer shaft, such as delivery catheter 206, and a deployed state shown in Figs. 4-5, in which the anchoring elements 238 are exposed from the tube, such as by being deployed out of delivery catheter 206, free to curl backwards, optionally through a layer of a target tissue.

[0120] In some examples, the anchoring elements 238 are configured to self-expand from the compacted state to a deployed state, which can be also referred to as a “flowered” or expanded state as illustrated in Figs. 4-5. This expansion may be achieved with a self-curving anchoring element body 242 that deflects the anchoring elements 238 radially outward from the central axis CA of the anchor device 230. The anchoring element bodies 242 of anchoring elements 238 extend from anchoring element bases 240 and terminate at anchoring tips 244 configured to facilitate penetration of and engagement with a target tissue, such as a host leaflet 10.

[0121] In some examples, an anchor head 236 can be a tube-cut anchor head. Manufacturing of a tube-cut anchor head 236 can employ any suitable cutting method for cutting the anchoring elements 238, such as, but not limited to, laser cutting, water-jet cutting, plasma cutting, and the like. In some examples, the anchoring elements 238 comprise a shape- memory material, such as Nitinol. In some examples, the expanded or flowered shape can be imparted to the memory of the shape-memory material with techniques known in the art (e.g., heat setting the shape).

[0122] In some examples, the anchor head 236 and the anchor shaft 232 are integrally formed, together defining a single one-piece unitary structure. In some examples, the anchoring elements 238 are integrally formed with the remainder of the anchor head 236, together defining a single one-piece unitary structure. In some examples, the anchoring element body 242 is relatively straight in the compacted configuration, and is curved outwardly and backwards in the deployed configuration. In some examples, a diameter defined by the anchoring tips 244 is greater in the deployed state than in the compacted state.

[0123] The anchor head 236 can be used in combination with the needle 212 which can extend through the anchor lumen 234 towards and through a host leaflet 10, for modifying the host leaflet 10. The anchor shaft 232 can extend through the delivery catheter lumen 208. In some examples, the delivery catheter 206 and the anchor shaft 232 can be configured to be axially movable with respect to each other. For example, a distally oriented movement of the anchor shaft 232 relative to the delivery catheter 206 can expose the anchor head 236 and anchoring elements 238 thereof from the delivery catheter 206.

[0124] In some examples, the apparatus 200 can include a handle 202, wherein the proximal ends of the delivery catheter 206, the anchor shaft 232 and/or the needle shaft 222 can be coupled to the handle 202. During delivery through the patient's vasculature, the handle 202 can be maneuvered by an operator (for example, a clinician or a surgeon) to axially advance or retract components of the apparatus 200, such as the delivery catheter 206, the anchor shaft 232 and/or the needle shaft 222.

[0125] The handle 202 can include, in some examples, a first handle portion 280 and a second handle portion 282 which are separable from each other (portion 280 and 282 indicated, for example, in Fig. 7). A first knob 204a (which may be referred to as an engagement knob) of the handle 202 can be configured to control a lock and release mechanism that can either maintain the two portions 280 and 282 coupled to each other, such as during utilization of the apparatus 200 for forming a pilot puncture 50 in a target tissue, and to allow separation of the second handle portion 282 from the first handle portion 280 after formation of the pilot puncture 50 is complete and retrieval of the needle 212 and anchor device 230 is desired.

[0126] The handle 202 can include a second knob 204b (which may be referred to as an anchor control knob), configured to control axial movement of the anchor device 230, and a third knob 204c (which may be referred to as a needle advancement knob) configured to control axial movement of the needle 212. In some examples, the second knob 204b and the third knob 204c are comprised in the second handle portion 282, wherein proximal portions of the anchor shaft 232 and the needle shaft 212 can be coupled to the second handle portion 282, such as to mechanisms of the second handle portion 282 controllable by the knobs 204, 204c.

[0127] In some examples, the handle 202 is not necessarily separable, and the first knob 204a can be optionally omitted. The handle 202 can include additional adjustment mechanisms controllable by additional knobs to maneuver additional components of the apparatus 200.

[0128] Various exemplary implementations for apparatus 200 and/or components thereof can be referred to, throughout the specification, with superscripts, for ease of explanation of features that refer to such exemplary implementations. It is to be understood, however, that any reference to structural or functional features of any apparatus, device or component, without a superscript, refers to these features being commonly shared by all specific exemplary implementations that can be also indicated by superscripts. In contrast, features emphasized with respect to an exemplary implementation of any apparatus, device or component, referred to with a superscript, may be optionally shared by some but not necessarily all other exemplary implementations. For example, tissue perforation apparatus 200^a, illustrated in Figs. 4-5, is exemplary implementations of tissue perforation apparatus 200, and thus can include any of the features described for tissue perforation apparatus 200 throughout the current disclosure, except that apparatus 200^a does not include an additional expansion member, such as a holedilating balloon of the type that will be described herein with respect to Figs. 13A-14K for example, extending between the anchor device 230 and the needle 212.

[0129] Figs. 6A-6C show a distal portion the anchor device 230 in different states of deployment relative to an outer shaft through which it extends. During advancement of the tissue perforation apparatus 200 towards a target tissue, the anchor head 236 can be surrounded by an outer shaft which maintains the anchoring elements 238 in a generally straight configuration, referred to as the compacted state of the anchor head 236. In some examples, the outer shaft can be the delivery catheter 206. In some examples, the outer shaft can be another shaft that can extend through the delivery catheter 206. Thus, it is to be understood that any reference to positioning and/or movement of the anchor device 230 relative to the delivery catheter 206 described herein and illustrated throughout the drawings, can similarly refer to positioning and/or movement of the anchor device 230 relative to any other type of an outer shaft, including a different shaft that can extend through a delivery catheter 206.

[0130] When the anchor device 230 is distally pushed relative to the delivery catheter 206, the anchoring elements 238 emerge from within the catheter 206. As the anchoring elements 238 emerge from the catheter 206, they are allowed to gradually assume their free or unrestricted configuration commensurate with the extent of distal advancement of the anchor device 230. For example, a partially deployed state is shown in Fig. 6B, wherein further distal advancement of the anchor device 230 will expose a longer portion of the anchor head 236, as illustrated in Fig. 6C for example.

[0131] Fig. 6D shows the deployed state of the anchor head 236 of Fig. 6C, further illustrating a target tissue, such as a host leaflet 10, to which the anchor head 236 is anchored in its deployed state. For example, the delivery catheter distal end 210 can be brought into contact with the target tissue while the anchor head 236 is retained in a compacted state within the delivery catheter, in a similar configuration to that shown in Fig. 6A. Subsequent advancement of the anchor device 230 relative to the delivery catheter 206 will cause the anchoring elements 238 to penetrate into the target tissue as they emerge out of the catheter 206. The length of the anchoring element bodies 242, defined between the anchoring element bases 240 and anchoring tips 244, can be longer than the thickness of the target tissue, such that as they anchor head 236 is pushed through the target tissue, the anchoring elements can pass through the thickness of the tissue and curl backwards, causing the anchoring tips 244 to penetrate through the tissue from the opposite side in the proximal direction, thereby anchoring the anchor head 236 to the target tissue, such as to a host leaflet 10, as shown in Fig. 6D.

[0132] In some examples, the tissue perforation apparatus 200 can be used as part of a tissue modification system 300. Fig. 7 shows an exemplary tissue modification system 300, which can include a steerable delivery apparatus 302. A steerable delivery apparatus 302 can include an outer catheter 310, optionally implemented as a steerable catheter. The steerable outer catheter 10 can be advanced towards the valvul ar structure 12 over a guidewire 80 terminating at a guidewire tip 82, and the delivery catheter 206 can be passed, along with the anchor device 230 and needle 212, through the outer catheter 310, over the guidewire 80, towards the host leaflet 10.

[0133] In some examples, the steerable delivery apparatus 302 can include a handle 304, wherein the outer catheter 310 can extend distally from the handle 304. The handle 304 can be maneuvered to control the outer catheter 310. In some examples, the handle 304 can include a steering mechanism configured to adjust the curvature of the distal end portion of the outer catheter 310. In the illustrated example, the handle 304 can include first knob 306a (which may also be referred to as a steering knob), which in turn is operatively coupled to the proximal end portion of a pull wire (not shown). The pull wire can extend distally from the handle 304 through the outer catheter 310 and has a distal end portion affixed to the outer catheter 310 at or near the distal end of the outer catheter 310. Rotating the knob 306a can increase or decrease the tension in the pull wire, thereby adjusting the curvature of the distal end portion of the outer catheter 310.

[0134] In some examples, the handle 304 can further include a securement second knob 306b (which may be referred to as a securing knob), configured to restrain movement of a shaft extending through the handle 304 and the outer shaft lumen 310 relative to the outer shaft 308. Further details on steering or flex mechanisms for the handle 304, as well as mechanisms for retraining movement of shaft extendable through the handle 304, can be found, for example, in U.S. Patent Nos. 7,780,723, 8,568,472, and 9,339,384, all of which are incorporated herein by reference in their entireties. The terms “tissue modification system 300” and “system 300”, as used herein, are interchangeable.

[0135] The steerable outer catheter 310 can be advanced through the patient's vasculature towards the target site of treatment, optionally without the tissue perforation apparatus 200, taking advantage of the steerability of the outer catheter 310 to navigate it during delivery, after which the delivery catheter 206 can be inserted through a rear port 308 of the handle 304 and advanced through the outer catheter 310.

[0136] Figs. 8A-8G illustrate some steps in a method for utilizing a tissue perforation apparatus 200, optionally extendable through an outer catheter 310 of a system 300, for forming an opening within a target tissue. Exemplary implementations of methods are illustrated in Figs. 8A-10E and 14A-14K with respect to modifying a host leaflet 10 of a host valvular structure 12, which can be performed prior to implanting a guest prosthetic valve inside the host valvular structure, as further described below with respect to Figs. 10F-10G for example. The apparatus 200 can be used to perforate a host leaflet 10, such as a native leaflet 30 or a prosthetic valve leaflet 114 of a previously implanted prosthetic valve.

[0137] The distal end portion of the apparatus 200, which can include an atraumatic distal end 210 of the delivery catheter 206, is configured to be advanced towards the host leaflet 10, optionally through a pre-inserted steerable outer catheter 310. Positioning the delivery catheter distal end 210 relative to the host leaflet 10 may comprise advancing the delivery catheter 206 toward the leaflet over the guidewire 80. The needle 212 can be configured to accommodate a guidewire 80 that can extend through the needle lumen 214.

[0138] During delivery, the anchor head 236 can be retained inside delivery catheter lumen 208, such that the anchoring tips 244 at or proximal to the delivery catheter distal end 210, as illustrated in Fig. 8A. This position maintains the anchor head 236 in the compacted state and conceals the sharp anchoring tips 244 from the surrounding anatomy, to protect the anatomical structures from being engaged or punctured by the anchoring tips 244 during advancement towards the site of treatment. The needle head 216 can be similarly retained inside the anchor device 230, such that the needle tip 220 is at or proximal to the anchoring tips 244. This position conceals the sharp tip 220 of the needle head 216 from the surrounding anatomy and/or outer catheter 310, to similarly protect them from being engaged or punctured by the sharp needle tip 220 during advancement towards the site of treatment.

[0139] In some examples, the delivery catheter distal end 210 can be advanced so as to contact, and/or be slightly pushed against, the host leaflet 10, as shown in Fig. 8B, which can stretch and/or flatten the host leaflet 10 to some extent along a plane perpendicular to the central axis CA of the anchor device 230, after which the anchor device 230 can be distally advanced relative to the delivery catheter 206 so as to expose a distal portion of the anchoring elements 238 out of delivery catheter lumen 208, causing the anchoring elements 238 to penetrate into and pass through the host leaflet 10, as shown in Fig. 8C. Flattening the portion of the leaflet 10 contacted by the delivery catheter 206 can advantageously ensure that most or all of the anchoring tip 244 engage with, and penetrate through, the host leaflet 10, during advancement of the anchor head 236.

[0140] As a greater portion of the anchoring element bodies 242 is pushed out of the delivery catheter 206, the anchoring elements 238 begin to bend back, orienting the anchoring tips 244 in the proximal direction as shown in Fig. 8C, wherein continues distal movement of the anchor device 230 will cause the anchoring tips 244 to penetrate through the host leaflet 10 from the distal surface of the leaflet 10 in the proximal direction, thereby grabbing the leaflet 10 in a manner that anchors the anchor head 236 thereto, as shown in Fig. 8D. In some examples, the anchoring tips 244 are positioned radially outward to the anchoring element bases 240 in the deployed state. In some examples, the anchoring tips 244 are proximal to the anchoring element bases 240 in the deployed state, as illustrated in Fig. 8D.

[0141] At this stage, as shown in Fig. 8E, the needle 212 can be distally advanced to puncture the host leaflet 10 to form a pilot puncture 50 within host leaflet 10, for example when its needle head 216 is axially translated relative to anchor device 230. An attempt to pass a needle 212 through a relatively thin and movable tissue component, such as a leaflet, in the absence of an anchor, might push the leaflet to some extent prior to eventually penetrating therethrough, which, even if achieving the goal of eventually puncturing the leaflet, might result in a wrong or somewhat offset position of the puncture hole due to this undesired relative movement. Advantageously, the anchor head 236 captures the host leaflet 10 and stabilizes it during formation of a pilot puncture 50 by a needle 212 being pushed against and through the host leaflet 10.

[0142] Once the needle head 216 is positioned, at least partially, past the host leaflet 10, the guidewire 80 can be advanced through the needle lumen 214 to terminate with guidewire tip 82 at a position distal to the pilot puncture 50 of host leaflet 10 as shown in Fig. 10B.

[0143] Subsequent to forming the pilot puncture 50 and optionally advancing the guidewire 80 to extend therethrough, the needle 212 can be optionally retracted, as shown in Fig. 8F, and the anchor device 230 can be can be proximally pulled relative to the delivery catheter and out of the pilot puncture, moving the anchor head 236 back to the compacted state with the anchoring elements 238 residing inside the delivery catheter, such that the anchoring tips 244 are positioned at or proximal to the delivery catheter distal end 210. The anchor device 230 along with the needle 212 can be then retracted away from the host leaflet 10, as shown in Fig. 8G, leaving the guidewire 80 extending through the pilot puncture 50.

[0144] While the anchor device 230 is shown to be proximally retracted away from the host leaflet 10 along with the delivery catheter 206 in Fig. 8G, it is to be understood that in some examples, the anchor device 230 can be proximally retracted relative to the delivery catheter 206, while the delivery catheter distal end 210 can remain in contact with, or in close proximity to, the host leaflet 10.

[0145] It is to be understood that the order of procedural steps described above with respect to Figs. 8E-8G is merely shown for illustrative purpose, and that in some examples, retraction of the anchor head 236 to release it from the host leaflet 10 can be performed prior to needle 212 retraction. In some examples, needle 212 retraction can be performed simultaneously with release and retraction of the anchor head 236 from the host leaflet 10.

[0146] In some examples, the guidewire 80 can be advanced simultaneously with advancement of the needle 212 during formation of the pilot puncture 50. In some examples, the guidewire 80 can be advanced to terminate distal to the host leaflet 10 after formation of the pilot puncture 50 by the needle 212. In some examples, the guidewire 80 can be advanced through pilot puncture 50 to terminate distal to the host leaflet 10 after retrieval of the needle 212, optionally prior to release of the anchor head 236 from the host leaflet 10.

[0147] In some examples, advancement of the guidewire 80 to position the guidewire tip 82 distal to the pilot puncture 50 can be performed subsequent to release and retraction of the anchor head 236 from the host leaflet 10, while the needle 212 is still positioned inside of pilot puncture 50, after which the needle 212 can be retracted. In some examples, advancement of the guidewire 80 to position the guidewire tip 82 distal to the pilot puncture 50 can be performed after needle 212 retraction while the anchor head 236 is still engaged with the host leaflet 10, after which the anchor head 236 can be released and retracted.

[0148] In some examples, a tissue modification system 300 can further include a dilation assembly 250, having an expansion member 268 configured to transition between a compacted state and an expanded state thereof. In some examples, the expansion member comprises a hole-dilating balloon 268 mounted on a balloon catheter 262, as shown in Fig. 9A for example. After formation of the pilot puncture 50, the needle 212 and the anchor device 230 can be retrieved from the patient's body, optionally by retraction through the outer catheter 310 and out of the handle 304 of steerable delivery apparatus 302, while leaving the outer catheter 310 in position and the guidewire 80 extending through the pilot puncture 50.

[0149] In some examples, the tissue perforation apparatus 200 can be completely removed from the system 300 after formation of the pilot puncture 50, such that the needle 212 and the anchor device 230 are retracted along with the delivery catheter 206 out of the patient's body and out of the handle 304 of steerable delivery apparatus 302, after which the balloon catheter 262 of dilation assembly 250 can be inserted, optionally through the rear port 308 of the handle 304, through the handle 304 and the outer catheter 310, as shown in Fig. 9A. In some examples, the balloon catheter 262 can be advanced through the outer catheter 310, optionally over the guidewire 80, towards the host leaflet 10, as shown for example in Fig. 9A.

[0150] The hole-dilating balloon 268 is configured to transition between a radially deflated state, shown for example in Figs. 10A-10C, and a radially inflated state, shown for example in Fig. 10D. The hole-dilating balloon 268 is configured to be positioned inside the pilot puncture 50, and expand the pilot puncture to form a tissue opening, such as a leaflet opening 52, as shown in Fig. 10D and explained in greater detail below.

[0151] An enlarged view of a distal portion of the dilation assembly 250 is illustrated in Fig. 9A, extending out of the outer catheter 310 for example. Cross-sectional views of the distal portion of the dilation assembly 250 are further shown throughout Figs. 10A-10E. The balloon catheter 262 can define a balloon catheter lumen 264, through which a guidewire 80, and one or more additional shafts of the dilation assembly 250, can optionally extend. The balloon catheter 262 can extend from a balloon catheter adaptor 272 that includes a first adaptor port 274a configured to receive a guidewire therethrough and a second adaptor port 274b configured to receive fluid from a fluid source.

[0152] As shown in Fig. 9A, when a dilation apparatus 250 is used in combination with a steerable delivery apparatus 302 after complete removal of the tissue perforation apparatus 200, the balloon catheter adaptor 272 can be positioned proximal to the handle 304 of the steerable delivery apparatus 302, while the distal end of the dilation assembly 250 can be slid over a portion of the guidewire 80 extending proximally from the handle 304, through the rear port 308 and into the handle 304, and further advanced over the guidewire 80 and through the outer catheter 310 towards the target tissue, such as host leaflet 10.

[0153] The second adaptor port 274b can be fluidly connectable to a fluid source (not shown) for inflating the hole-dilating balloon 268. The fluid source comprises an inflation fluid. The term “inflation fluid”, as used herein, means a fluid (for example, saline, though other liquids or gas can be used) used for inflating the hole-dilating balloon 268. The inflation fluid source is in fluid communication with the balloon catheter lumen 264, such that fluid from the fluid source can flow through the balloon catheter lumen 264 into hole-dilating balloon 268 to inflate it.

[0154] In some examples, an inflatable balloon 268 of assembly 250, utilized as a hole-dilating balloon, can be different from a typical balloon used for expanding balloon-expandable prosthetic valves or stents, in that while a typical valve-expanding balloon is inflatable to a diameter that can allow expansion of a prosthetic valve to a functional diameter thereof, which can be similar to, or greater than (for example, in the case of valve over-expansion) the diameter of the native annulus in which the valve is deployed, the maximum diameter of a hole-dilating balloon 268 can be significantly smaller, configured to increase the size of a pilot puncture 50 to form a larger leaflet opening 52, optionally without tearing the host leaflet 10 (though in some examples, the host leaflet 10 may be still torn by a hole-dilating balloon 268).

[0155] In some examples, such as when dilation of a pilot puncture 50 is desired to form a larger leaflet opening 52, without necessarily tearing the leaflet 10, the maximum diameter to which the hole-dilating balloon 268 can be inflated is equal to or less than 12 mm. Tn some examples, the maximum diameter to which the hole-dilating balloon 268 can be inflated is equal to or less than 10 mm. Nevertheless, as mentioned above, in some examples a holedilating balloon 268 can be configured to tear a host leaflet 10, in which case the maximum diameter to which the hole-dilating balloon 268 can be greater than 12 mm., such as in a range of 20-25 mm.

[0156] In some examples, a dilation assembly 250 can further include a dilator 252 that can be conical or frustoconical in shape, and include a dilator tapering portion 256 terminating at a dilator distal end 254, and a dilator proximal portion 258 that can be coupled to a dilator shaft 270 that extends proximally therefrom. A dilator lumen 260 continuously extends through the dilator shaft 270 and the dilator 252, open ended at the dilator distal end 254. Attachment of the dilator shaft 270 to the dilator proximal portion 258 can be achieved by a variety of methods, such as overmolding, radio-frequency welding, through an adhesive, and/or a combination thereof. In some examples (not illustrated), the dilator shaft 270 can extend through the entire length of the dilator 252, such that a distal end of the dilator shaft 270 is aligned with the dilator distal end 254. In some examples (not illustrated), the dilator shaft 270 is coupled to one or more components, such as collars or other connectors, which are in turn attached to the dilator 252.

[0157] In some examples, the hole-dilating balloon 268 is coupled to a distal end portion of the balloon catheter 262 at its proximal end, while the balloon's distal end can be coupled, directly or indirectly, to another component of the assembly 250, such as the dilator 252 or dilator shaft 270. In the examples illustrated in Figs. 9A-10E, the hole-dilating balloon 268 is shown to be coupled to the dilator proximal portion 258. The dilator proximal portion 258 can optionally include an outer step configured to accommodate the distal end of the hole-dilating balloon 268, such that the outer surface of the hole-dilating balloon 268 can be flush or otherwise relatively continuous with the outer surface of the dilator 252. [0158] In some examples, such as when the hole-dilating balloon 268 is attached at both ends thereof to the dilator 252 and balloon catheter 262, both the dilator 252 with dilator shaft 270 and the balloon catheter 262 can be configured to move simultaneously in the axial direction, without necessarily being axially movable relative to each other, or while axial movement of one relative to the other is limited. In such examples, axial movement of the balloon catheter 262 can cause the dilator shaft 270 to move therewith, or axial movement of one of the dilator shaft 270 or dilator 252 can cause the balloon catheter 262 to move therewith.

[0159] The dilator shaft 270 can extend through the balloon catheter lumen 264, and may be sized such that an annular space is formed within balloon catheter lumen 264 between an inner surface of the balloon catheter 262 and an outer surface of the dilator shaft 270 along the length of balloon catheter 262. This annular space is in fluid communication with one or more inflation openings 266 exposed to an internal cavity of the hole-dilating balloon 268, which can be in fluid communication, via adaptor port 274b of balloon catheter adaptor 272, with a fluid source (for example, a syringe or a pump) that can inject inflation fluid (for example, saline) into the hole-dilating balloon 268, so as to inflate the balloon 268, for example during formation of a leaflet opening 52 as will be described in greater detail below and shown, for example, in Fig. 10D. The pressure of the inflation fluid within hole-dilating balloon 268 may provide the force that allows it to dilate a leaflet opening 52. Further, the balloon catheter lumen 264 may be configured to withdraw fluid from the balloon 268 through the inflation opening(s) 266, to deflate the balloon 268.

[0160] In some examples, the handle 202 of a tissue perforation apparatus 200 can be non- separable, for example provided without a first knob 204a configured to enable separation between portions thereof, and the apparatus 200 can be completely retrieved from the patient’ s body, and optionally from the steerable delivery apparatus 302, including the handle 202, the delivery catheter 206, the anchor device 230, and the needle 212. In some examples, as described above, the handle 202 can include two portions 280, 282 which are separable from each other, such when a first knob 204a of such an exemplary handle 202 is actuated to separate the handle portions 280 and 282, the anchor device 230 and the needle 212 can be removed, along with the second handle portion 282, from the first handle portion 280.

[0161] In some examples, after forming the pilot puncture 50 and releasing the anchor device 230 from engagement with the host leaflet 10, the first knob 204a can be actuated to allow separation of the second handle portion 282 from the first handle portion 280. The second handle portion 282 can be then proximally pulled, while the first handle portion 280 remains in position, such that the anchor device 230 and the needle 212 can be retracted through the delivery catheter lumen 208 and out of the handle 304 of steerable delivery apparatus 302, while the delivery catheter 206 can remain in situ, extending through the outer catheter 310 towards the host leaflet 10. In such examples, as shown in Fig. 9B, the dilation assembly 250 can be inserted into the delivery catheter 206 and advanced through the delivery catheter lumen 208, optionally over the guidewire 80, towards the host leaflet 10.

[0162] In some cases, a steerable outer catheter 310 of the steerable delivery apparatus 302 can be steered towards the site of treatment so as to generally face the host valvular structure 12. The smaller-sized delivery catheter 206 can be then extended out of the outer catheter 310, and may be more easily oriented towards a specific desired host leaflet 10 in which a pilot puncture needs to be formed. In such cases, insertion of the balloon catheter 262 into the delivery catheter 206 as exemplified in Fig. 9B, can facilitate easier navigation thereof towards the specific host leaflet 10 and its pilot puncture 50, compared to direct insertion of the balloon catheter 262 into an outer catheter 310 from which the delivery catheter is removed, as exemplified in Fig. 9A.

[0163] While a dilation assembly 250 is shown in Figs 9A-9B to extend through an outer catheter 310 and over a guide wire 80 that remain in situ after retraction of the anchor device 230 and needle 212, either directly inserted through the handle 304 of apparatus 302 after removal of the delivery catheter 206 as well, as shown in Fig. 9A, or inserted into a delivery catheter 206 that remains in position inside the outer catheter 310, as shown in Fig. 9B, it is to be understood that these configurations are shown by way of illustration and not limitation. In some examples, the guidewire 80 can be retrieved from the patient's body while the outer catheter 310 remains in situ, with the delivery catheter 206 either retrieved as well or remaining inside the outer catheter, prior to insertion of the balloon catheter 262. The same guidewire 80 or a different guidewire can be then optionally reinserted, for example through the first adapter port 274a of the balloon catheter adaptor 272, over which the balloon catheter 262 can be guided towards the pilot puncture 50 of the host leaflet 10, through the outer catheter 310 and/or delivery catheter 206.

[0164] In some examples, both the tissue perforation apparatus 200 and the steerable delivery apparatus 302 can be retrieved from the patient's body, while only the guidewire 80 can remain in situ, optionally extending through the pilot puncture, such that the balloon catheter 262 can be guided over the guide wire 80 towards the host leaflet 10.

[0165] Figs. 10A-10E illustrate some steps in a method for utilizing a dilation assembly 250 for forming an opening by dilating a previously formed puncture in a target tissue, such as a host leaflet 10. Subsequent to forming the pilot puncture 50 and after retraction of the anchor device 230 and needle 212, the hole-dilating balloon 268, carried over the balloon catheter 262, can be advanced towards the host leaflet 10 according to any of the methods described above. Thus, while the balloon catheter 262 is illustrated in Figs. 10A-10E to extend through an outer catheter 310, it is to be understood that this is shown by way of illustration and not limitation, and that the balloon catheter can extend similarly through a delivery catheter 206 that can optionally extend through the outer catheter 310, or it can be advanced towards the host leaflet 10 without passing through any of the outer catheter 310 and/or delivery catheter 206.

[0166] In some examples, when the dilation assembly 250 further includes a dilator 252 as also shown in the example illustrated in Fig. 10A, the dilator 252 can be advanced, optionally along with the balloon catheter 262 and hole-dilating balloon 268, towards the host leaflet 10. When included in dilation assembly 250, the dilator 252 can be inserted into the pilot puncture 50 to expand the pilot puncture 50, as shown in Fig. 10B. As the dilator 252 is inserted into the host leaflet 10, the inherent resiliency of the leaflet 10 may urge the leaflet 10 radially inwardly against the dilator 252. The dilator 252 can have sufficient stiffness to facilitate advancement thereof through the leaflet 10, wherein the gradually tapering shape of the dilator 252 facilitates expanding the pilot puncture 50 to a greater diameter.

[0167] In a subsequent step of the method, illustrated in Fig. 10C, the hole-dilating balloon 268 may be inserted within the pilot puncture 50, such as by further advancement of the dilator 252 with dilator shaft 270 and/or balloon catheter 262. With the hole-dilating balloon 268 received within the pilot puncture 50, inflating the hole-dilating balloon 268 to transition it from a radially deflated state (Fig. 10C) to a radially inflated state (Fig. 10D) can expand the pilot puncture 50 to form a leaflet opening 52 that is sized to receive the prosthetic valve 100 in the radially compressed or crimped configuration. After the hole-dilating balloon 268 is inflated to form the leaflet opening 52 as shown in Fig. 10D, the hole-dilating balloon 268 is deflated, as shown in Fig. 10E, optionally allowing for insertion of a guest prosthetic valve inside the leaflet opening 52.

[0168] In some examples, inflating the hole-dilating balloon 268 within the host leaflet 10 serves to increase a diameter of the pilot puncture 50 such that the resulting leaflet opening 52 is a hole with an increased diameter relative to the pilot puncture 50. In some examples in which the leaflet opening 52 is a hole, the leaflet opening 52 may be a substantially circular hole. In some examples, the leaflet opening 52 may be non-circular (for example, elliptical or asymmetric). In such examples, the diameter of the leaflet opening 52 may refer to any suitable dimension of the leaflet opening 52, such as a minimum diameter of the leaflet opening 52, a maximum diameter of the leaflet opening 52, and/or an average diameter of the leaflet opening 52.

[0169] In some examples, inflating the hole-dilating balloon 268 within the host leaflet 10 may cause the host leaflet 10 to rip and/or tear such that the leaflet opening 52 is not a bounded hole. Stated differently, in such examples, the leaflet opening 52 may be formed by a tear that extends from the pilot puncture 50 fully to the free edge of the host leaflet 10 (the coaptation edge of the leaflet).

[0170] While a dilation assembly 250 that includes a hole-dilating balloon 268 is described above and illustrated for expanding a pilot puncture 50 to form a leaflet opening 52, it is to be understood that other types of expansion member can be used instead of a balloon in any of the methods and/or systems described herein. For example, U.S. Provisional Application No. 63/335,739, which is incorporated herein by reference in its entirety, describes an expandable frame that can be used as an expansion member instead of a valve-expanding balloon.

[0171] In some examples, retraction of the hole-dilating balloon 268, after deflation thereof, can be performed while the guidewire 80 may be kept in position, extending through the leaflet opening 52. Subsequent to deflation of the hole-dilating balloon 268 (or recompressing of any other type of an expansion member) inside the leaflet opening 52 and retracting it away from the host leaflet 10, the method can further include steps of positioning a guest prosthetic valve 100 inside the leaflet opening 52. A replacement valve delivery apparatus 350 carrying the guest prosthetic valve 100 can be either part of the system 300, or provided as a separate assembly of apparatus 350 advanced into a leaflet opening 52.

[0172] Fig. 10F shows a guest prosthetic valve 100 positioned, in a radially compressed configuration thereof, inside the leaflet opening 52. As shown in Fig. 10F, the guest prosthetic valve 100 can be mounted on a replacement valve delivery apparatus 350 that can be advanced towards the host leaflet 10 over a guidewire, which can be a separate guidewire (not shown), or can be the same guidewire 80.

[0173] In some examples, the guest prosthetic valve is a balloon expandable valve, and the replacement valve delivery apparatus 350 comprises a balloon catheter 352 carrying a valveexpanding balloon 354. In contrast to some examples of a hole-dilating balloon 268 described above, such as a hole-dilating balloon 268 configured to form a leaflet opening 52 without tearing the host leaflet, the maximum diameter to which a valve-expanding balloon 354 can be inflated can be, in some examples, greater than 18 mm., greater than 20 mm., greater than 23 mm., greater than 26 mm., and/or greater than 29 mm. [0174] While a replacement valve delivery apparatus 350 equipped with a valve-expanding balloon 354 at a distal end portion of a balloon catheter 352 is illustrated, it is to be understood that this is shown by way of illustration and not limitation, and that a replacement valve delivery apparatus 350 can include other shafts and/or mechanisms, for example when utilized to advance and expand other types of replacement prosthetic valves, such as self-expandable prosthetic valves or mechanically expandable prosthetic valves.

[0175] In some examples, the replacement valve delivery apparatus 350 can further include a nosecone 356 positioned distal to the valve-expanding balloon 354 (or other prosthetic-valve expanding mechanism). The nosecone 356 can be conical or frustoconical in shape. The nosecone 356 can be attached to a distal end of a nosecone shaft 358 extending through the balloon catheter 352, wherein the nosecone 356 and the nosecone shaft 358 can collectively define a lumen through which a guidewire can extend. In some examples, when a nosecone 356 is present at a distal end of the replacement valve delivery apparatus 350 as also shown in the example illustrated in Fig. 10F, the nosecone 356 can be advanced towards the host leaflet 10, and may optionally have a maximal diameter that can be somewhat greater than the diameter of the opening 52, such that as the nosecone 356 is inserted into the leaflet opening 52 it can optionally further expand the leaflet opening 52 to a greater diameter.

[0176] As shown in Fig. 10F, the guest prosthetic valve 100 is placed in the leaflet opening 52 in its radially compressed configuration, optionally positioned over a deflated valve-expanding balloon 354 in the case of a balloon-expandable prosthetic valve. With the prosthetic valve 100 received within the leaflet opening 52, radially expanding the guest prosthetic valve 100, as shown in Fig. 10G, can serve to increase a size of the leaflet opening 52 and/or to tear the leaflet. As a result, and as discussed above, radially expanding the guest prosthetic valve 100 can serve to modify the host leaflet 10 such that the leaflet does not obstruct a cell opening 112 in a frame 102 of the guest prosthetic valve 100 or at least increases the area of the host valve and the guest valve that is not covered or obstructed by the modified host leaflet to permit access and sufficient perfusion to the adjacent coronary artery. For example, radially expanding the guest prosthetic valve within the leaflet opening 52 can operate to push a portion of the leaflet extending radially exterior of the guest prosthetic valve below an upper edge of an outer skirt of the guest prosthetic valve 100 and/or away from one or more cell openings 112 of the guest prosthetic valve 100.

[0177] In some examples, the guest prosthetic valve can be a mechanically-expandable prosthetic valve and radial expansion thereof can be achieved by actuating a mechanical actuator of the guest prosthetic valve to mechanically expand a frame of the guest prosthetic valve. In some examples, the guest prosthetic valve can be a self-expandable prosthetic valve that can be retained during delivery toward the host valvular structure in a capsule or other restraint disposed therearound, and valve expansion can be achieved by removing the capsule or other restraint from the guest prosthetic valve to allow it to radially self-expand within the host valvular structure.

[0178] Figs. 11A-12B illustrate a sequence of events in which a host valvular structure 12 is modified to receive a guest prosthetic valve 100. Figs. 11A-11B illustrate the hole-dilating balloon 268 utilized to expand the pilot puncture 50 into the leaflet opening 52. In particular, Fig. 11 A illustrates the hole-dilating balloon 268 in a deflated state within the pilot puncture 50, corresponding to the state described above with respect to Fig. 10C, while Fig. 11B illustrates the hole-dilating balloon 268 in an inflated state such that the pilot puncture 50 has enlarged into the leaflet opening 52, corresponding to the state described above with respect to Fig. 10D. Fig. 11C illustrates a guest prosthetic valve 100 that can be positioned in the leaflet opening 52 after removal of the hole-dilating balloon 268 therefrom, in a crimped configuration of the prosthetic valve 100, corresponding to the state described above with respect to Fig. 10F, after which the guest prosthetic valve 100 can be expanded, such as by inflating a valveexpanding balloon 354 over which it can be mounted in the case of a balloon-expandable valve, so as to implant the guest prosthetic valve 100 inside the host valvular structure 12.

[0179] As mentioned, any system, apparatus and method of the current specification can be utilized for forming a leaflet opening 52 in a host leaflet 10 which can be either a native leaflet 30 or a prosthetic valve leaflet 114 of a previously implanted prosthetic valve, such as prosthetic valve 100a of Fig. 3, such as in the case of ViV procedures. Fig. 12A shows a previously implanted prosthetic valve 100a subsequent to forming the leaflet opening 52. Fig. 12B shows a configuration in which a second prosthetic valve 100b has been expanded within the leaflet opening 52 of a host prosthetic valve 100a. In the example of Fig. 12B, the guest prosthetic valve 100b is the same type of valve as the host prosthetic valve 100a. It is to be understood, however, that ViV procedures may be similarly applied to any other suitable valvular structures, such as different prosthetic valves and/or native heart valves. For example, the guest prosthetic valve 100b need not be the same type of valve as the host prosthetic valve 100a.

[0180] In the example of Fig. 12A, when the prosthetic valve leaflets 114a of the previously implanted prosthetic valve 100a are pressed against the frame 102a, the leaflet opening 52 provides a partial access into the frame 102a, but the leaflet opening 52 may not be sufficiently large to completely uncover any of the cell openings 112a of the frame 102a. [0181] As shown in Fig. 12B, however, fully expanding the guest prosthetic valve 100b within the leaflet opening 52 further expands and/or tears the leaflet opening 52 such that several cell openings 112a of the frame 102a of the host prosthetic valve 100a and several cell openings 112b of the frame 102b of the guest prosthetic valve 100b are fully uncovered by the leaflets 114a. In some examples, this may result from the frame 102b of the guest prosthetic valve 100b pushing the leaflet 114a comprising the leaflet opening 52 downwardly (toward the inflow ends of the prosthetic valves 100a, 100b) such that one or more cell openings 112a are unobstructed by the leaflet 1 14a. In some examples, expanding the frame 102b within the leaflet 1 14a comprising the leaflet opening 52 may rip and/or tear this leaflet 114a such that the leaflet 114a cannot obstruct one or more cell openings 112a.

[0182] While a tissue perforation apparatus 200^a is described herein in as part of a tissue modification system 300 that includes a steerable delivery apparatus 302 equipped with an outer catheter 310 through which a distal portion of the tissue perforation apparatus 200^a can be advanced, it is to be understood that any exemplary tissue perforation apparatus 200 disclosed herein can be used in isolation, and without a separate steerable delivery apparatus 302.

[0183] Figs. 13A and 13B show a view in perspective and a cross-sectional view, respectively, of a distal portion of an exemplary stabilized tissue perforation apparatus 200^b. Apparatus 200^b is an exemplary implementation of apparatus 200, and thus includes all of the features described for apparatus 200 throughout the current disclosure, except that apparatus 200^b further comprises the dilation assembly 250 disposed inside of, and axially movable relative to, the anchor device 230. The apparatus 200^b can optionally comprise a dilator 252 attached to a dilator shaft 270, and the hole-dilating balloon 268 can be optionally disposed between a distal end of the balloon catheter 262 and the dilator proximal portion 258 according to any of the examples described above for dilation assembly 250. The needle 212 extends through the dilator lumen 260, and is configured to be axially movable in the distal and proximal direction relative to the dilation assembly 250.

[0184] In some examples, the balloon catheter 262 and the needle 212 can be configured to be axially movable relative to each other. For example, a distally oriented movement of the balloon catheter 262 relative to the needle 212, and/or a proximally oriented movement of the needle 212 relative to the balloon catheter 262, can expose the hole-dilating balloon 268 out the needle lumen 214.

[0185] It is to be understood that any reference throughout the specification and the claims, to two components which are axially movable relative to each other, is not limited to both of the components being able to axially move relative to the other when the other component is maintained axially immovable, but rather to either one of the components being axially movable relative to the other component, or both being axially movable relative to each other. For example, a reference to a needle and a dilation assembly being axially movable with respect to each other can refer either to the needle being movable in the proximal or distal direction relative to the dilation assembly, top the dilation assembly being movable in the proximal or distal direction relative to the needle, or both.

[0186] In some examples, the tissue perforation apparatus 200^b further comprises a protective shaft 290 disposed inside the anchor lumen 234, optionally between the anchor device 230 and the dilation assembly 250. In some examples, the dilation assembly 250 can extend through a lumen 294 of the protective shaft 290.

[0187] In some examples, the protective shaft 290 and the anchor device 230 can be configured to be axially movable relative to each other. For example, a distally oriented movement of the protective shaft 290 relative to anchor device 230, and/or a proximally oriented movement of the anchor device 230 relative to the protective shaft 290, can expose a distal end portion 292 of the protective shaft 290 out the needle lumen 214.

[0188] In some examples, the dilation assembly 250 and the protective shaft 290 can be configured to be axially movable relative to each other. For example, a distally oriented movement of the dilation assembly 250 relative to the protective shaft 290, and/or a proximally oriented movement of the protective shaft 290 relative to the dilation assembly 250, can expose a distal portion of the dilation assembly 250, which can include its expansion member, such as a hole-dilating balloon 268, out the protective shaft lumen 294.

[0189] In some examples, the balloon catheter 262 and the anchor device 230 can be configured to be axially movable relative to each other. For example, a distally oriented movement of the balloon catheter 262 relative to the anchor device 230, and/or a proximally oriented movement of the anchor device 230 relative to the balloon catheter 262, can expose the hole-dilating balloon 268 out the anchor lumen 234.

[0190] In some examples, the balloon catheter 262 and the protective shaft 290 can be configured to be axially movable relative to each other. For example, a distally oriented movement of the balloon catheter 262 relative to the protective shaft 290, and/or a proximally oriented movement of the protective shaft 290 relative to the balloon catheter 262, can expose the hole-dilating balloon 268 out the protective shaft lumen 294.

[0191] The protective shaft 290 can include a distal end portion 292 which can be, in some examples, an atraumatic distal end portion 292, such as by being rounded or otherwise blunted. The shaft distal end portion 292 can be formed as an integral distal portion of the protective shaft 290, or as a separate component attached to the protective shaft 290.

[0192] When a balloon catheter 262 carrying an inflatable hole-dilating balloon 268 extends through the anchor device 230, it may be important to protect the hole-dilating balloon 268 from being accidentally contacted by the sharp anchoring tips 244. Thus, a protective shaft 290 that can be disposed between the anchor head 236 and the hole-dilating balloon 268 can advantageously protect the hole-dilating balloon 268 from being punctured by the anchoring tips 244.

[0193] Figs. 14A-14K illustrate exemplary steps in a method for utilizing an apparatus 200^b for forming an opening within a target tissue, such as a host leaflet 10. The distal end portion of the apparatus 200^b, which can include a distal end 210 of the deliver)' catheter 206 and/or the dilator 252 of dilation assembly 250, is configured to be inserted into a patient’s vasculature, such as within an ascending aorta, and to be advanced towards the host leaflet 10. Positioning the distal end 210 of the delivery catheter 206 and/or the dilator 252 relative to the host leaflet 10 may comprise advancing the delivery catheter 206 and/or dilator 252 toward the leaflet over a guidewire 80 as described above with respect to Fig. 8A for example. For example, the needle lumen 214 can be configured to accommodate a guidewire 80 that can extend through the needle lumen 214. The guidewire 80 can be inserted into the patient’s vasculature, and then the needle 212 and/or other shafts or tubes of the apparatus 200 may be advanced toward the host leaflet 10 over the guide wire 80.

[0194] During delivery, the anchor head 236 can be retained inside delivery catheter lumen 208, such that the anchoring tips 244 at or proximal to the delivery catheter distal end 210, as illustrated in Fig. 14A. As explained above, this position conceals the anchoring tips 244 from the surrounding anatomy, to protect the anatomical structures from being engaged or punctured by the anchoring tips 244 during advancement towards the site of treatment, and at the same time serves to maintain the anchor head 236 in a compacted state. The needle head 216 can be retained inside the dilator lumen 260, such that the sharp needle tip 220 is at or proximal to the dilator distal end 254, as also illustrated in Fig. 14A. This position conceals the sharp tip of the needle 212 from the surrounding anatomy, to similarly protect the anatomical structures from being engaged or punctured by the sharp needle tip 220 during advancement towards the site of treatment.

[0195] The protective shaft 290 can extend through the anchor lumen 234 so as to protect the hole-dilating balloon 268 from being contacted by the anchoring tips 244. Upon reaching the site of treatment, such as the host valvular structure 12, the delivery catheter distal end 210 can be advanced so as to contact, and/or be slightly pushed against, the host leaflet 10, as shown in Fig. 14B, optionally stretching and/or flattening the host leaflet 10 to some extent, as described above with respect to Fig. 8B.

[0196] In some examples, prior to, or simultaneously with, anchoring of the anchor head 236 to the host leaflet 10, the protective shaft 290 can be distally advanced, relative to the balloon catheter 262, closer to, and optionally up to the axial position of, the host leaflet 10, as shown in Fig. 14C.

[0197] The needle 212 can be distally advanced to puncture the host leaflet 10 to form a pilot puncture 50 within host leaflet 10 as shown in Fig. 14D, for example when the needle head 216 is axially translated relative to dilation assembly 250. Once the needle head 216 is positioned, at least partially, past the host leaflet 10, the guidewire 80 can be optionally advanced through the needle lumen 214 to terminate with guidewire tip 82 at a position distal to the pilot puncture 50 of host leaflet 10, as shown in Fig. 14E.

[0198] Subsequent to forming the pilot puncture 50 and optionally advancing the guidewire 80, and as shown in Fig. 14F, the dilator 252 can be inserted into the pilot puncture 50 to expand the pilot puncture 50. As the dilator 252 is inserted into the host leaflet 10, the inherent resiliency of the leaflet 10 may urge the leaflet 10 radially inwardly against the dilator 252. Advantageously, keeping the anchor head 236 engaged with the host leaflet 10, while the dilator 252 is passed therethrough, provides adequate counter force that facilitates passage of the dilator 252 through the pilot puncture 50, wherein the gradually tapering shape of the dilator 252 can expand the pilot puncture 50 to a greater diameter.

[0199] The needle head 216 can be re-concealed within dilator lumen 260, such as due to advancement of dilation assembly 250 in a distal direction over the needle head 216 as shown in Fig. 14F, and/or retraction of needle 212 such that the sharp needle tip 220 is at or proximal to the dilator distal end 254, to avoid damage that may be caused to internal anatomical structures of the surrounding anatomy due to accidental contact with the sharp needle tip 220. [0200] In some examples, the guidewire 80 can be advanced simultaneously with advancement of the needle 212 during formation of the pilot puncture 50. In some examples, the guidewire 80 can be advanced to terminate distal to the host leaflet 10 after formation of the pilot puncture 50 by the needle 212, as illustrated in Fig. 14E. In some examples, the guidewire 80 can be advanced to terminate distal to the host leaflet 10 prior to advancement of the dilator 252 through the pilot puncture 50. In some examples, the guidewire 80 can be advanced simultaneously with advancement of the dilator 252 into and through the pilot puncture 50 after formation of the pilot puncture 50 by the needle 212. [0201] In some examples, the needle 212 can be retracted back into dilator lumen 260 prior to advancement of the dilator 252 into pilot puncture 50, in which case the dilator 252 can be guided through the pilot puncture 50 of host leaflet 10 over a guide wire 80 distally advanced into and through pilot puncture 50, optionally prior to retraction of the needle 212.

[0202] Prior to advancement of the dilation assembly 250 to position the hole-dilating balloon 268 inside the pilot puncture 50, the anchor device 230 can be proximally pulled relative to the delivery catheter 206, so as to release the anchor head 236 from the host leaflet 10 and returning it to a compacted state inside the delivery catheter 206, after which both the anchor device 230 and delivery catheter 206 can be proximally pulled away from the host leaflet 10, as shown in Fig. 14G. Advantageously, the protective shaft 290 protects the hole-dilating balloon 268 from being contacted by the sharp anchoring tips 244 during retraction of the anchor head 236.

[0203] After proximally pulling the anchor head 236 and delivery catheter 206 to a position proximal to the hole-dilating balloon 268, such that the anchor head 236 no longer poses a risk of engaging with the balloon 268, the protective shaft 290 is proximally pulled relative to the dilation assembly 250, so as to expose the hole-dilating balloon 268 as shown in Fig. 14H.

[0204] In a subsequent step of the method, illustrated in Fig. 141, the hole-dilating balloon 268 may be inserted within the pilot puncture 50, such as by further advancement of the dilation assembly 250. With the hole-dilating balloon 268 received within the pilot puncture 50, inflating the hole-dilating balloon 268 to transition it from a radially deflated state (Fig. 141) to a radially inflated state (Fig. 14J) can expand the pilot puncture 50 to form a leaflet opening 52 that is sized to receive the prosthetic valve 100 in the radially compressed or crimped configuration. After the hole-dilating balloon 268 is inflated to form the leaflet opening 52 as shown in Fig. 14J, the balloon 268 is deflated, as shown in Fig. 14K, optionally allowing for insertion of a guest prosthetic valve inside the leaflet opening 52, in a manner similar to that described above with respect to Figs. 10F-10G.

[0205] While a tissue perforation apparatus 200 is described above for use in a method for forming a leaflet opening prior to implantation a guest prosthetic valve 100 inside a host valvular structure 12, it is to be understood that any exemplary tissue perforation apparatus 200 disclosed herein can be used to form a puncture or opening in any target tissue, including, but not limited to, a leaflet, in any other procedure that may not require utilization of an expansion member, such as a hole-dilating balloon 268, to further expand the opening, and may not involve procedural steps of guest prosthetic valve implantation.

[0206] Any of the systems, devices, apparatus, etc. disclosed herein can be sterilized (for example, with heat, radiation, and/or chemicals, etc.) to ensure they are safe for use with patients, and any of the methods herein can include sterilization of the associated assembly, device, apparatus, etc. as one of the steps of the method. Examples of radiation for use in sterilization include, without limitation, gamma radiation and ultra-violet radiation. Examples of chemicals for use in sterilization include, without limitation, ethylene oxide and hydrogen peroxide.

Some Examples of the Disclosed Technology

[0207] Some examples of above-described technology are enumerated below. It should be noted that one feature of an example in isolation or more than one feature of the example taken in combination and, optionally, in combination with one or more features of one or more examples below are examples also falling within the disclosure of this application.

[0208] Example 1. A tissue perforation apparatus comprising: an outer shaft; an anchor device extending through, and axially movable relative to, the outer shaft, wherein the anchor device comprises an anchor head comprising a plurality of anchoring elements; and a needle extending through, and axially movable relative to, the anchor device; wherein the anchor head is configured to move between a compacted state, in which the plurality of anchoring elements are retained inside the outer shaft, and a deployed state, in which exposed portions of the plurality of anchoring elements are bent radially outwards.

[0209] Example 2. The apparatus of any example herein, particularly of example 1, wherein the plurality of anchoring elements are curled backwards in the deployed state.

[0210] Example 3. The apparatus of any example herein, particularly of example 1 or 2, wherein each of the anchoring elements terminates at an anchoring tip.

[0211] Example 4. The apparatus of any example herein, particularly of example 3, wherein a diameter defined by the anchoring tips in the deployed state is greater than a diameter defined by the anchoring tips in the compacted state.

[0212] Example 5. The apparatus of any example herein, particularly of example 3 or 4, wherein each anchoring element comprises an anchoring element body extending between an anchoring element base and the corresponding anchoring tip.

[0213] Example 6. The apparatus of any example herein, particularly of example 5, wherein the anchoring element body is straight in the compacted state.

[0214] Example 7. The apparatus of any example herein, particularly of example 5 or 6, wherein the anchoring element body is curled in the deployed state.

[0215] Example 8. The apparatus of any example herein, particularly of any one of examples 5 to 7, wherein the anchoring tips are proximal to the anchoring element bases in the deployed state. [0216] Example 9. The apparatus of any example herein, particularly of any one of examples 1 to 8, wherein the anchor head comprises a shape-memory material.

[0217] Example 10. The apparatus of any example herein, particularly of any one of examples 1 to 9, wherein the shape-memory material comprises Nitinol.

[0218] Example 11. The apparatus of any example herein, particularly of any one of examples 1 to 10, wherein the anchor head is shape-set to assume the deployed state when the anchoring elements are exposed out of the outer shaft.

[0219] Example 12. The apparatus of any example herein, particularly of any one of examples 1 to 11, wherein the needle further comprises a needle head terminating at a needle tip.

[0220] Example 13. The apparatus of any example herein, particularly of example 12, wherein the needle further comprises a needle shaft proximally extending from the needle head.

[0221] Example 14. The apparatus of any example herein, particularly of example 13, wherein the needle shaft comprises a plurality of needle shaft circumferential slits.

[0222] Example 15. The apparatus of any example herein, particularly of example 14, wherein the needle shaft comprises a needle shaft distal portion comprising the plurality of needle shaft circumferential slits.

[0223] Example 16. The apparatus of any example herein, particularly of example 15, wherein the needle shaft further comprises a needle shaft proximal portion extending proximally from the needle shaft distal portion.

[0224] Example 17. The apparatus of any example herein, particularly of example 16, wherein the needle shaft proximal portion is devoid of circumferential slits.

[0225] Example 18. The apparatus of any example herein, particularly of example 16 or 17, wherein the proximal portion of the needle shaft comprises a polymeric material.

[0226] Example 19. The apparatus of any example herein, particularly of any one of examples 12 to 18, wherein the needle head defines an angled surface terminating at the needle tip.

[0227] Example 20. The apparatus of any example herein, particularly of any one of examples 1 to 19, wherein the outer shaft comprises a delivery catheter

[0228] Example 21. The apparatus of any example herein, particularly of example 20, wherein the delivery catheter comprises an atraumatic delivery catheter distal end.

[0229] Example 22. The apparatus of any of any example herein, particularly of any one of examples 1 to 21, further comprising a dilation assembly extending through the anchor device, the dilation assembly comprising an expansion member movable between a compacted state and an expanded state. [0230] Example 23. The apparatus of any example herein, particularly of example 22, wherein the anchor device and the dilation assembly are movable relative to each other.

[0231] Example 24. The apparatus of any example herein, particularly of example 22 or 23, wherein the needle extends through the dilation assembly.

[0232] Example 25. The apparatus of any example herein, particularly of example 24, wherein the needle and the dilation assembly are movable relative to each other.

[0233] Example 26. The apparatus of any example herein, particularly of any one of examples 22 to 25, further comprising a protective shaft disposed between the anchor device and the dilation assembly.

[0234] Example 27. The apparatus of any example herein, particularly of example 26, wherein the anchor device and the protective shaft are axially movable relative to each other.

[0235] Example 28. The apparatus of any example herein, particularly of example 26 or 27, wherein the protective shaft comprises an atraumatic protective shaft distal end portion.

[0236] Example 29. The apparatus of any example herein, particularly of any one of examples 22 to 28, wherein the expansion member is a hole-dilating balloon mounted on a balloon catheter of the dilation assembly, wherein the compacted state of the expansion member is a deflated state of the hole-dilating balloon, and wherein the expanded state of the expansion member is an inflated state of the hole-dilating balloon.

[0237] Example 30. The apparatus of any example herein, particularly of example 29, wherein the dilation assembly further comprises a dilator attached to a dilator shaft extending proximally therefrom.

[0238] Example 31. The apparatus of any example herein, particularly of example 30, wherein the dilator comprises a dilator tapering portion.

[0239] Example 32. The apparatus of any example herein, particularly of example 30 or 31, wherein the dilator shaft extends through the balloon catheter.

[0240] Example 33. The apparatus of any example herein, particularly of any one of examples 30 to 32, wherein the hole-dilating balloon is attached at a proximal end thereof to the balloon catheter, and at a distal end of the hole-dilating balloon to the dilator.

[0241] Example 34. The apparatus of any example herein, particularly of any one of examples 1 to 33, wherein the needle is configured to form a pilot puncture in a target tissue.

[0242] Example 35. The apparatus of any example herein, particularly of example 34, wherein the anchoring elements are configured to penetrate through the target tissue. [0243] Example 36. The apparatus of any example herein, particularly of example 35, wherein the anchoring elements are configured to anchor the anchor head to the target tissue in the deployed state.

[0244] Example 37. The apparatus of any example herein, particularly of any one of examples 34 to 36, wherein the target tissue is a host leaflet of a host valvular structure, and wherein the tissue opening is a leaflet opening.

[0245] Example 38. The apparatus of any example herein, particularly of example 37, wherein the host valvular structure is a native valvular structure of a native heart valve.

[0246] Example 39. The apparatus of any example herein, particularly of example 37, wherein the host valvular structure is a valvular structure of previously implanted prosthetic valve that is implanted within a native heart valve.

[0247] Example 40. A method comprising: advancing a tissue perforation apparatus to a target tissue over a guidewire, wherein the tissue perforation apparatus comprises an anchor device extending through an outer shaft, and a needle extending through the anchor device; approximating a distal end of the outer shaft to the target tissue; anchoring an anchor head of the anchor device to the target tissue by distally advancing the anchor head relative to the outer shaft, thereby causing anchoring elements of the anchor head to penetrate through the target tissue; and forming a pilot puncture through the target tissue by advancing a needle head of the needle against the target tissue.

[0248] Example 41. The method of any example herein, particularly of example 40, wherein the advancing the tissue perforation apparatus comprises maintaining the anchor head inside the outer shaft.

[0249] Example 42. The method of any example herein, particularly of example 41, wherein the approximating the distal end of the outer shaft to the target tissue comprises maintaining the anchor head inside the outer shaft.

[0250] Example 43. The method of any example herein, particularly of example 41 or 42, wherein the anchoring the anchor head comprises moving the anchor head from a compacted state to a deployed state thereof.

[0251] Example 44. The method of any example herein, particularly of any one of examples 40 to 43, wherein the anchoring the anchor head comprises exposing a length of the anchoring elements that allows the anchoring elements to curl backwards.

[0252] Example 45. The method of any example herein, particularly of any one of examples 40 to 44, wherein the forming the pilot puncture comprises distally advancing the needle relative to the anchor device. [0253] Example 46. The method of any example herein, particularly of any one of examples 40 to 45, wherein the needle head comprises an angled surface and terminates at a needle tip.

[0254] Example 47. The method of any example herein, particularly of example 46, wherein the forming the pilot puncture comprises piercing the target tissue by the needle tip.

[0255] Example 48. The method of any example herein, particularly of any one of examples 40 to 47, wherein the needle comprises a needle shaft extending proximally from the needle head, the needle shaft comprising a plurality of needle shaft circumferential slits.

[0256] Example 49. The method of any example herein, particularly of example 48, wherein the needle shaft comprises a needle shaft distal portion comprising the plurality of needle shaft circumferential slits.

[0257] Example 50. The method of any example herein, particularly of example 49, wherein the needle shaft further comprises a needle shaft proximal portion extending proximally from the needle shaft distal portion.

[0258] Example 51. The method of any example herein, particularly of example 50, wherein the needle shaft proximal portion is devoid of circumferential slits.

[0259] Example 52. The method of any example herein, particularly of example 49 or 50, wherein the proximal portion of the needle shaft comprises a polymeric material.

[0260] Example 53. The method of any example herein, particularly of any one of examples 40 to 52, wherein the outer shaft comprises a delivery catheter.

[0261] Example 54. The method of any example herein, particularly of example 53, wherein the approximating the distal end of the outer shaft comprises pushing an atraumatic distal end of the delivery catheter against the target tissue.

[0262] Example 55. The method of any example herein, particularly of any one of examples 40 to 54, further comprising, after the forming the pilot puncture, advancing a dilation assembly towards the pilot puncture.

[0263] Example 56. The method of any example herein, particularly of example 55, wherein the dilation assembly comprises an expansion member configured to transition between a compacted state and an expanded state thereof.

[0264] Example 57. The method of any example herein, particularly of example 56, wherein the dilation assembly further comprises a dilator distal to the expansion member, and a dilator shaft attached to the dilator and extending proximally therefrom.

[0265] Example 58. The method of any example herein, particularly of example 57, wherein the dilator comprises a tapering portion. [0266] Example 59. The method of any example herein, particularly of example 58, wherein the advancing the dilation assembly comprises passing the dilator through the pilot puncture, thereby expanding the pilot puncture.

[0267] Example 60. The method of any example herein, particularly of any one of examples 56 to 59, wherein the advancing the dilation assembly comprises positioning the expansion member, in its compacted state, within the pilot puncture.

[0268] Example 61. The method of any example herein, particularly of example 60, further comprising, after the positioning the expansion member inside the pilot puncture, expanding the expansion member inside the pilot puncture to dilate the pilot puncture and form a tissue opening within the target tissue.

[0269] Example 62. The method of any example herein, particularly of example 61, further comprising, after the expanding the expansion member, compressing the expansion member.

[0270] Example 63. The method of any example herein, particularly of example 62, further comprising, after the forming the pilot puncture, releasing the anchor head from the target tissue.

[0271] Example 64. The method of any example herein, particularly of example 63, wherein the releasing the anchor head comprises proximally pulling the anchor head into the outer shaft. [0272] Example 65. The method of any example herein, particularly of any one of examples 62 to 64, further comprising, after the forming the pilot puncture, retracting the needle from the target tissue.

[0273] Example 66. The method of any example herein, particularly of any one of examples 62 to 65, further comprising, before the advancing the dilation assembly, retrieving the anchor device and the needle.

[0274] Example 67. The method of any example herein, particularly of example 62, wherein the advancing the tissue perforation apparatus comprises maintaining an expansion member in its compacted state, inside the anchor device.

[0275] Example 68. The method of any example herein, particularly of example 67, wherein the advancing the tissue perforation apparatus comprises maintaining an expansion member proximal to the distal end of the outer shaft.

[0276] Example 69. The method of any example herein, particularly of example 67 or 68, wherein the advancing the tissue perforation apparatus comprises maintaining an expansion member proximal to the anchor head. [0277] Example 70. The method of any example herein, particularly of any one of examples 67 to 69, wherein the advancing the tissue perforation apparatus comprises maintaining the needle head inside a dilator lumen of the dilation assembly.

[0278] Example 71. The method of any example herein, particularly of any one of examples 67 to 70, wherein the tissue perforation apparatus further comprises a protective shaft disposed between the anchor device and the dilation assembly.

[0279] Example 72. The method of any example herein, particularly of example 71, wherein the advancing the tissue perforation apparatus comprises maintaining the expansion member inside the protective shaft.

[0280] Example 73. The method of any example herein, particularly of example 71 or 72, further comprising, before the positioning the expansion member inside the pilot puncture, advancing the protective shaft towards the target tissue.

[0281] Example 74. The method of any example herein, particularly of example 73, wherein the advancing the protective shaft towards the target tissue comprises advancing the protective shaft relative to the dilation assembly.

[0282] Example 75. The method of any example herein, particularly of example 74, further comprising, before the expanding the expansion member, retracting the needle from the target tissue.

[0283] Example 76. The method of any example herein, particularly of example 74 or 75, further comprising, before the expanding the expansion member, retracting the protective shaft from around the expansion member.

[0284] Example 77. The method of any example herein, particularly of example 76, further comprising, before the retracting the protective shaft, releasing the anchor head from the target tissue and retracting the anchor head to a position proximal to the expansion member.

[0285] Example 78. The method of any example herein, particularly of any one of examples 62 to 77, wherein the expansion member is a hole-dilating balloon mounted on a balloon catheter of the dilation assembly, wherein the expanding the expansion member comprises inflating the hole-dilating balloon, and wherein the compressing the expansion member comprises deflating the hole-dilating balloon.

[0286] Example 79. The method of any example herein, particularly of any one of examples 62 to 78, further comprising, after the compressing the expansion member, retracting the expansion member from the target tissue. [0287] Example 80. The method of any example herein, particularly of example 79, wherein the target tissue is a host leaflet of a host valvular structure, and wherein the tissue opening is a leaflet opening.

[0288] Example 81. The method of any example herein, particularly of example 80, further comprising, after the retracting the expansion member, positioning a guest prosthetic valve in a radially compressed state thereof within the host valvular structure, and radially expanding the guest prosthetic valve.

[0289] Example 82. The method of any example herein, particularly of example 81 , wherein the positioning the guest prosthetic valve within the host valvular structure comprises positioning the guest prosthetic valve within the leaflet opening.

[0290] Example 83. The method of any example herein, particularly of example 82, wherein the positioning the guest prosthetic valve within the host valvular structure comprises positioning the guest prosthetic valve between host leaflets of the host valvular structures.

[0291] Example 84. The method of any example herein, particularly of any one of examples 81 to 83, wherein the radially expanding the guest prosthetic valve comprises inflating a valveexpanding balloon over which the guest prosthetic valve is disposed.

[0292] Example 85. The method of any example herein, particularly of any one of examples 81 to 83, wherein the radially expanding the guest prosthetic valve comprises actuating a mechanical actuator of the guest prosthetic valve.

[0293] Example 86. The method of any example herein, particularly of any one of examples 81 to 83, wherein the guest prosthetic valve is a self-expandable prosthetic valve, and wherein radially expanding the guest prosthetic valve comprises removing a restraint from around the guest prosthetic valve.

[0294] Example 87. The method of any example herein, particularly of any one of examples 80 to 86, wherein the host valvular structure is a native valvular structure of a native heart valve.

[0295] Example 88. The method of any example herein, particularly of any one of examples 80 to 86, wherein the host valvular structure is a valvular structure of previously implanted prosthetic valve that is implanted within a native heart valve.

[0296] Example 89. The method of any example herein, particularly of example 87 or 88, wherein the native heart valve is an aortic valve.

[0297] It is appreciated that certain features of the disclosure, which are, for clarity, described in the context of separate examples, may also be provided in combination in a single example. Conversely, various features of the disclosure, which are, for brevity, described in the context of a single example, may also be provided separately or in any suitable sub-combination or as suitable in any other described example of the disclosure. No feature described in the context of an example is to be considered an essential feature of that example, unless explicitly specified as such.

[0298] In view of the many possible examples to which the principles of the disclosure may be applied, it should be recognized that the illustrated examples are only preferred examples and should not be taken as limiting the scope. Rather, the scope is defined by the following claims. We therefore claim all that comes within the scope and spirit of these claims.

Claims

WE CLAIM:

1. A tissue perforation apparatus comprising: an outer shaft; an anchor device extending through, and axially movable relative to, the outer shaft, wherein the anchor device comprises an anchor head comprising a plurality of anchoring elements; and a needle extending through, and axially movable relative to, the anchor device; wherein the anchor head is configured to move between a compacted state, in which the plurality of anchoring elements are retained inside the outer shaft, and a deployed state, in which exposed portions of the plurality of anchoring elements are bent radially outwards.

2. The apparatus of claim 1, wherein the plurality of anchoring elements are curled backwards in the deployed state.

3. The apparatus of claim 1 or 2, wherein each of the anchoring elements terminates at an anchoring tip.

4. The apparatus of claim 3, wherein a diameter defined by the anchoring tips in the deployed state is greater than a diameter defined by the anchoring tips in the compacted state.

5. The apparatus of claim 3 or 4, wherein each anchoring element comprises an anchoring element body extending between an anchoring element base and the corresponding anchoring tip.

6. The apparatus of claim 5, wherein the anchoring element body is straight in the compacted state.

7. The apparatus of claim 5 or 6, wherein the anchoring element body is curled in the deployed state.

8. The apparatus of any one of claims 1 to 7, wherein the anchor head is shape-set to assume the deployed state when the anchoring elements are exposed out of the outer shaft.

9. The apparatus of any one of claims 1 to 8, further comprising a dilation assembly extending through the anchor device, the dilation assembly comprising an expansion member movable between a compacted state and an expanded state.

10. The apparatus of claim 9, wherein the needle extends through the dilation assembly.

11. The apparatus of any one of claims 9 or 10, further comprising a protective shaft disposed between the anchor device and the dilation assembly.

12. A method comprising: advancing a tissue perforation apparatus to a target tissue over a guidewire, wherein the tissue perforation apparatus comprises an anchor device extending through an outer shaft, and a needle extending through the anchor device; approximating a distal end of the outer shaft to the target tissue; anchoring an anchor head of the anchor device to the target tissue by distally advancing the anchor head relative to the outer shaft, thereby causing anchoring elements of the anchor head to penetrate through the target tissue; and forming a pilot puncture through the target tissue hy advancing a needle head of the needle against the target tissue.

13. The method of claim 12, wherein the anchoring the anchor head comprises exposing a length of the anchoring elements that allows the anchoring elements to curl backwards.

14. The method of any one of claims 12 or 13, further comprising, after the forming the pilot puncture, advancing a dilation assembly towards the pilot puncture.

15. The method of claim 14, wherein the dilation assembly comprises an expansion member configured to transition between a compacted state and an expanded state thereof.

16. The method of any one of claims 14 or 15, wherein the advancing the dilation assembly comprises positioning the expansion member, in its compacted state, within the pilot puncture.

17. The method of claim 16, further comprising, after the positioning the expansion member inside the pilot puncture, expanding the expansion member inside the pilot puncture to dilate the pilot puncture and form a tissue opening within the target tissue.

18. The method of claim 17, further comprising, after the expanding the expansion member, compressing the expansion member.

19. The method of claim 18, further comprising, after the forming the pilot puncture, releasing the anchor head from the target tissue.

20. The method of any one of claims 17 or 19, further comprising, after the compressing the expansion member, retracting the expansion member from the target tissue.

21. The method of claim 20, wherein the target tissue is a host leaflet of a host valvular structure, and wherein the tissue opening is a leaflet opening.

22. The method of claim 21, further comprising, after the retracting the expansion member, positioning a guest prosthetic valve in a radially compressed state thereof within the host valvular structure, and radially expanding the guest prosthetic valve.