Tissue perforation systems and handles thereof

Abstract

The present disclosure relates to tissue perforation devices and methods for use thereof. In an example, a tissue perforation apparatus comprises a handle (202), a delivery catheter (208), an anchor device (244, 242) extendable through the delivery catheter, and a needle (218) extending through the anchor device. The handle includes a first handle portion (204) and a second handle portion (206) which is releasable coupled to the first handle portion. The delivery catheter is rigidly attached to the first handle portion. The anchor device includes an anchor shaft coupled to the second handle portion and rotatable by an anchor control knob (480) of the second handle portion. The needle comprises a needle shaft coupled to the second handle portion and axially movable relative to the anchor device by a needle advancement knob (530) of the second handle portion.

Description

TISSUE PERFORATION SYSTEMS AND HANDLES THEREOFCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 561,985, filed March 6, 2024, and U.S. Provisional Application No. 63 / 681,992, filed August 12, 2024, the contents of which are herein incorporated by reference in their entirety.FIELD

[0002] The present disclosure relates to apparatus and methods for forming an opening in a target tissue, and to handles of tissue perforation apparatus that include separable handle portions.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 atranscatheter 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 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. A helical anchor can be anchored to the leaflet prior to piercing thereof by the needle, to stabilize the leaflet during advancement thereof through the tissue. Described herein are handle mechanisms designed to control the operation of an anchor device and a needle of a tissue perforation apparatus. The disclosed tissue perforation apparatus and methods for use thereof can help to ensure an opening is safely and accurately formed in a target leaflet.

[0007] In one of its basic configurations, a tissue perforation apparatus comprises a handle, the handle comprising a first handle portion and a second handle portion releasably coupled to the first handle portion. 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 tissue perforation apparatus can comprise a delivery catheter optionally rigidly attached, at a delivery catheter proximal end portion thereof, to the first handle portion.

[0009] In some examples, the tissue perforation apparatus can comprise an anchor device.

[0010] In some examples, the anchor device can comprise an anchor shaft optionally coupled to the second handle portion.

[0011] In some examples, the anchor shaft can optionally be configured to rotate upon actuation of an anchor control knob of the second handle portion.

[0012] In some examples, the anchor device can comprise a helical anchor head distal to the anchor shaft.

[0013] In some examples, the tissue perforation apparatus can comprise a needle.

[0014] In some examples, the needle can comprise a needle shaft optionally coupled to the second handle portion.

[0015] In some examples, the needle shaft can optionally be configured to be axially moved relative to the anchor shaft upon actuation of a needle advancement knob of the second handle portion.

[0016] In some examples, the needle can comprise a needle head at a distal end of the needle shaft.

[0017] In some examples, the needle shaft can optionally extend through the anchor shaft.

[0018] In some examples, the anchor shaft can optionally extend through the delivery catheter when the second handle portion is coupled to the first handle portion.

[0019] In some examples, the second handle portion and the first handle portion can optionally be axially movable relative to each other.

[0020] In some examples, the needle advancement knob can comprise a lead member defining a lead bore, and wherein the needle shaft can optionally be rigidly attached to a carriage of the second handle portion, wherein the carriage can optionally reside inside the lead bore and can be axially movable within the lead bore.

[0021] In some examples, the second handle portion can comprise a safety knob movable between a locking position and an unlocking position, wherein the safety knob can optionally be configured to prevent rotational movement of the needle advancement knob in the locking position, and can optionally allow rotational movement of the needle advancement knob in the unlocking position.

[0022] In some examples, the safety knob can optionally be biased to the locking position.

[0023] In some examples, the first handle portion can comprise a valve assembly positioned inside the distal support body.

[0024] In some examples, the valve assembly can comprise a cross-slit valve, a disc valve distal to the cross-slit valve, and a hemostatic valve distal to the disc valve.

[0025] In some examples, the first handle portion can comprise an engagement knob configured to control engagement of the first handle portion with the second handle portion.

[0026] In some examples, the first handle portion can comprise a plurality of locking balls, each locking ball can optionally reside in a radial hole extending from an outer surface of the distal housing to the inner surface of the distal housing.

[0027] In some examples, the distal section of the extension body can comprise a plurality of notches configured to accept the plurality.

[0028] In some examples, the plurality of notches can comprise a plurality of notch groups axially spaced from each other.

[0029] In some examples, the engagement knob can optionally be configured to move the handle between a connected configuration, by radially pressing the locking balls against the distal section of the extension body .in a manner that can prevent movement between the second handle portion and the first handle portion, and a released configuration, by allowing the locking balls to be radially spaced from the distal section of the extension body.

[0030] In some examples, the engagement knob can comprise a knob internal thread, wherein the distal section of the extension body can comprise a body outer thread configured to threadedly engage with the knob internal thread.

[0031] In some examples, when the body outer thread can be threadedly engaged with the knob internal thread, rotation of the engagement knob can optionally facilitate axial movement of the second handle portion relative to the first handle portion.

[0032] In some examples, the second handle portion can comprise a safety latch optionally coupled to the distal section of the extension body, wherein the safety latch can comprise a proximal latch portion, a distal latch portion, and a tooth extending radially from the distal latch portion.

[0033] In some examples, the anchor shaft can comprise a helical hollow strand tube.

[0034] In one of its basic methods, a method comprises advancing a distal portion of a tissue perforation apparatus, over a guidewire, inside a patient's body to a target tissue. 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.

[0035] In some examples, the tissue perforation apparatus optionally comprises a handle.

[0036] In some examples, the handle optionally comprises a first handle portion and a second handle portion releasably attached to the first handle portion.

[0037] In some examples, the tissue perforation apparatus optionally comprises a delivery catheter.

[0038] In some examples, the delivery catheter is optionally attached to the first handle portion.

[0039] In some examples, the tissue perforation apparatus optionally comprises an anchor device.

[0040] In some examples, the anchor device optionally comprises an anchor shaft coupled to the second handle portion.

[0041] In some examples, the anchor shaft optionally extends through the delivery catheter.

[0042] In some examples, the tissue perforation apparatus optionally comprises a needle coupled to the second handle portion.

[0043] In some examples, the needle optionally extends through the anchor shaft.

[0044] In some examples, the method can comprise forming a pilot puncture in the target tissue by rotating a needle advancement knob of the second handle portion in a first rotational direction of the needle advancement knob, which causes distal axial movement of the needle relative to the anchor device.

[0045] In some examples, the method optionally comprises, after the forming the pilot puncture, retracting the needle from the pilot puncture.

[0046] In some examples, the method optionally comprises, releasing the helical anchor head from the target tissue.

[0047] In some examples, the method optionally comprises, after the releasing the helical anchor head, retrieving the anchor device and the needle from the patient's body, while maintaining the delivery catheter in position.

[0048] In some examples, the retrieving the anchor device and the needle can optionally comprise releasing the second handle portion from the first handle portion and proximally pulling the second handle portion away from the first handle portion.

[0049] In some examples, the method optionally comprises, after the retrieving the anchor device and the needle from the patient's body, advancing a dilation apparatus comprising an expansion member to the target tissue.

[0050] In some examples, the advancing the dilation apparatus can optionally comprise inserting the expansion member into the delivery catheter and advancing the expansion member through the delivery catheter.

[0051] In one of its basic configurations, a tissue perforation apparatus comprises a first handle portion comprising a delivery catheter, and a second handle portion comprising an anchor shaft. 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.

[0052] In some examples, the first handle portion can comprise a delivery catheter.

[0053] In some examples, the delivery catheter can optionally be coupled to, and can optionally extend distally from, the first handle portion.

[0054] In some examples, the second handle portion can comprise an anchor shaft.

[0055] In some examples, an anchor can optionally be coupled to a distal end of the anchor shaft.

[0056] In some examples, the anchor shaft can optionally be coupled to, and optionally extend distally from, the second handle portion.

[0057] In some examples, the second handle portion can comprise a needle shaft.

[0058] In some examples, a needle head can optionally be formed at a distal end of the needle shaft.

[0059] In some examples, the second handle portion can optionally be releasably attachable to the first handle.

[0060] In some examples, the second the anchor shaft can optionally extend through the delivery catheter when the second handle portion is coupled to the first handle portion.

[0061] In some examples, the needle shaft can optionally extend through the anchor shaft.

[0062] In some examples, the second handle portion can comprise an anchor control knob, and wherein the anchor shaft can be configured to rotate upon actuation of the anchor control knob.

[0063] In some examples, the anchor can be a helical anchor.

[0064] In one of its basic methods, a method comprises advancing a tissue perforation apparatus to a target tissue inside a patient, wherein the tissue perforation apparatus comprises a first handle portion and a second handle portion releasably attached to the first handle portion. 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.

[0065] In some examples, the first handle portion optionally comprises a delivery catheter.

[0066] In some examples, the second handle portion optionally comprises an anchor device extending through the delivery catheter.

[0067] In some examples, the method can comprise anchoring the anchor device to the target tissue.

[0068] In some examples, the method can comprise forming a pilot puncture in the target tissue.

[0069] In some examples, the second handle portion can optionally comprise an anchor control knob, wherein the anchor device can comprise an anchor shaft and an anchor head at the distal end of the anchor shaft, wherein the anchoring the anchor device to the target tissue canoptionally comprise rotating the anchor control knob, thereby causing the anchor shaft and the anchor head to rotate and penetrate the target tissue.

[0070] In some examples, the second handle portion can optionally comprise a needle advancement knob, and wherein the forming the pilot puncture in the target tissue can comprise rotating the needle advancement knob, which causes distal axial movement of the needle relative to the anchor device and through the target tissue.

[0071] In one of its basic configurations, a dilation apparatus comprises a balloon catheter, a balloon mounted on the balloon catheter, a dilator distal to the balloon, and a tear-away sleeve comprising a sleeve body and at least one weakened line extending along the sleeve body. 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.

[0072] In some examples, the balloon catheter can define a balloon catheter lumen.

[0073] In some examples, the balloon can optionally be in fluid communication with the balloon catheter lumen.

[0074] In some examples, the balloon can optionally be configured to transition between deflated and inflated states thereof.

[0075] In some examples, the dilator can comprise a dilator tapering portion terminating at a dilator distal end.

[0076] In some examples, the sleeve body can optionally extend distally from a proximal portion of the tear-away sleeve and terminate at a distal end.

[0077] In some examples, the at least one weakened line can optionally be configured to tear when a tearing force is applied thereto by the proximal portion.

[0078] In some examples, the at least one weakened line optionally comprises a thinned line.

[0079] In some examples, the at least one weakened line optionally comprises two axially extending weakened lines.

[0080] In some examples, the two weakened lines can optionally be diametrically opposite to each other.

[0081] In some examples, the sleeve body can optionally be configured to split to two halves when the two weakened lines are tom.

[0082] In some examples, the at least one weakened line can optionally extend helically along the sleeve body.

[0083] In some examples, the at least one weakened line can optionally be formed by laser etching.

[0084] In some examples, the two weakened lines can optionally be formed along elongated folds of the sleeve body when temporarily compressed to a flattened configuration.

[0085] 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

[0086] 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:

[0087] Fig. 1 is a sectional view of an aortic root.

[0088] 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.

[0089] Fig. 2B shows the implanted prosthetic heart valve of Fig. 1A as viewed from the ascending aorta, according to an example.

[0090] Fig. 3 shows a valve-in- valve implantation within the native aortic valve of Fig. 1, according to an example.

[0091] Fig. 4 illustrates an exemplary tissue perforation apparatus that includes an anchor device and a needle extendable through a delivery catheter.

[0092] Fig. 5 shows a perspective sectional view of a distal portion of an exemplary tissue perforation apparatus.

[0093] Figs. 6A-6B are cross-sectional views of an exemplary handle that includes first and second handle portions, taken along orthogonal cutting planes.

[0094] Fig. 7 is a cross-sectional view along line 7-7 of Fig. 6B.

[0095] Fig. 8A is a partial cross-sectional view of the handle in a released configuration thereof, showing the first handle portion and the second handle portion separated from each other.

[0096] Fig. 8B is a partial cross-sectional view of the handle in a connected configuration thereof, showing the first handle portion and the second handle portion connected to each other.

[0097] Fig. 9A is a partial perspective view of the handle of Fig. 8B.

[0098] Fig. 9B is a partial perspective view of the handle of Fig. 9A, wherein the engagement knob is shown with partial transparency.

[0099] Figs. 10A and 10B are cross-sectional views taken along line 10A-10A of Fig. 8B and line 10B-10B of Fig. 8A, respectively.

[0100] Fig. 11 A is a perspective view of an exemplary distal housing of the handle.

[0101] Fig. 1 IB is a cross-sectional view taken along line 1 IB- 1 IB of Fig. 11 A.

[0102] Figs. 12A and 12B are cross-sectional views taken along line 12-12 of Fig. 8B, in states that correspond to the position of the engagement knob in Figs. 10 A and 10B, respectively.

[0103] Fig. 13 is an enlarged perspective view of a portion of the handle that includes the engagement knob shown with partial transparency.

[0104] Fig. 14 shows a cross-sectional view of an exemplary handle having a safety knob shown in an unlocking position thereof.

[0105] Fig. 15 shows a cross-sectional view of an exemplary handle equipped with flushing ports.

[0106] Fig. 16A and 16B are isometric views of a rear portion of the handle, showing the safety knob in locking and unlocking positions thereof, respectively.

[0107] Figs. 17A and 17B are isometric views of a rear portion of the handle corresponding to the safety knob positions of Figs. 16A and 16B, with the proximal housing of the handle removed from view to expose some components of the second handle portion.

[0108] Fig. 18 is a cross sectional view of an exemplary handle that includes a safety latch.

[0109] Fig. 19 is a perspective view of the handle of Fig. 18, showing the first handle portion and the second handle portion separated from each other.

[0110] Figs. 20A-20C are cross-sectional views of a distal portion of the handle, shown in different states of the safety latch and different positions of the handle portions relative to each other.

[0111] Fig. 21 shows a proximal end portion of an exemplary anchor device that includes a reinforcement tube.

[0112] Figs. 22A and 22B are perspective and front views of an exemplary connector body adapted to connect with the anchor device of Fig. 21, respectively.

[0113] Fig. 23 is a cross-sectional view of a portion of the handle including the anchor device of Fig. 21 engaged with the connector body of Figs. 22A-22B.

[0114] Fig. 24 is a perspective view of the anchor device of Fig. 21 engaged with the connector body of Fig. 23, wherein the connector body is shown with partial transparency.

[0115] Figs. 25A and 25B are perspective sectional and cross-sectional views along line 25-25 of Fig. 23, respectively.

[0116] Fig. 26 shows an exemplary stabilized tissue modification system which includes a steerable delivery apparatus through which the tissue perforation apparatus extends.

[0117] Figs. 27A-27F illustrate steps in a method for creating a pilot puncture in the leaflet.

[0118] Fig. 28 shows an exemplary dilation apparatus of the system extending through a delivery catheter that extends through the steerable delivery apparatus.

[0119] Figs. 29A-29E illustrate steps in a method for forming a leaflet opening.

[0120] Fig. 29F is a simplified side view of a guest prosthetic valve positioned in a crimped configuration inside the leaflet opening formed in the existing valvular structure.

[0121] Fig. 29G is a simplified side view of the guest prosthetic valve of Fig. 29F expanded inside the existing valvular structure.

[0122] Fig. 30A shows the balloon positioned within a pilot puncture of the host leaflet in a deflated state.

[0123] Fig. 30B shows the balloon of Fig. 30A inflated within the host leaflet.

[0124] Fig. 30C shows the guest prosthetic valve positioned in the leaflet opening after removal of the balloon of Fig. 30B.

[0125] Fig. 31 A is a perspective view of a host prosthetic valve subsequent to forming a leaflet opening thereof.

[0126] Fig. 3 IB is a perspective view of a guest prosthetic valve expanded within a leaflet opening of a host prosthetic valve.

[0127] Fig. 32 is a perspective view of an exemplary tear-away sleeve.

[0128] Fig. 33 is a side view of the tear-away sleeve of Fig. 32 fitted over a distal portion of a dilation apparatus.

[0129] Fig. 34 shows a dilation apparatus with a tear-away sleeve prior to insertion into and through a handle portion.

[0130] Fig. 35 is a cross-sectional view showing the dilation apparatus with the tear-away sleeve extending through the first handle portion.

[0131] Fig. 36 is a perspective view of an exemplary tear-away sleeve which is devoid of proximal tabs.

[0132] Fig. 37 shows initiation of splitting or tearing the tear-away sleeve.

[0133] Fig. 38 shows an exemplary the tear-away sleeve partially flattened to form weakened lines thereof.

[0134] Figs. 39A is a side view of an exemplary tear-away sleeve that includes a helically- extending weakened line, in an untorn configuration thereof.

[0135] Figs. 39B shows the tear-away sleeve of Fig. 39A in a torn configuration.DETAILED DESCRIPTION

[0136] 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.

[0137] 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.

[0138] 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.

[0139] 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".

[0140] 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.

[0141] 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.

[0142] 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.

[0143] The terms "axial direction", "radial direction", and "circumferential direction" have been used herein to describe the arrangement and assembly of components relative to thegeometry 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.

[0144] 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.

[0145] 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.

[0146] 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.

[0147] 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.

[0148] 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.

[0149] 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.

[0150] Described herein are devices and methods for puncturing a tissue, such as a leaflet, which can be performed as part of a procedure 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, a tissue piercing assembly that includes a needle 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.).

[0151] 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 30can 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.

[0152] 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 (which can optionally be similar to delivery apparatus 670 described herein with respect to Figs. 29F-29G and 30G) 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.

[0153] 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 (which can optionally be similar to delivery apparatus 670 described herein with respect to Figs. 29F-29G and 30G). 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 / 085,947 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 prostheticvalve 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.

[0154] Figs. 2A-2B show an example of a prosthetic valve 100, which can optionally 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.

[0155] 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.

[0156] The term "inflow", as used herein, refers to a region of the prosthetic valve through which the blood flows into the prosthetic valve 100.

[0157] 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.

[0158] 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.

[0159] The terms "longitudinal" and "axial", as used herein, refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined.

[0160] 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 optionally 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 ofshape-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.

[0161] 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 optionally 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.

[0162] The struts 108 can optionally include a plurality of angled struts and vertical or axial struts. At least some of the struts 108 can optionally be pivotable or bendable relative to each other, so as to permit frame expansion or compression. For example, the frame 102 can optionally 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.

[0163] A valvular structure 113 of the prosthetic valve 100 can optionally 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 optionally 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 optionally be made from, in whole or part, biological material (for example, pericardium), biocompatible 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 11,135,056, all of which are incorporated herein by reference in their entireties.

[0164] In some examples, the prosthetic valve 100 can optionally comprise at least one skirt or sealing member. For example, the prosthetic valve 100 can optionally include an inner skirt (not shown in Fig. 2A-2B), which can optionally 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 1 14 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 optionally be disposed around and attached to the inner surface of frame 102, while the leaflets can optionally be sutured to the inner skirt along a scalloped line (not shown). An inner skirt can be optionally coupled to the frame 102 via sutures or another form of coupler.

[0165] The prosthetic valve 100 can optionally 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 optionally be coupled to the frame 102 via sutures or another form of coupler.

[0166] Any of the inner skirt and / or outer skirt can optionally 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 optionally 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 optionally be formed of a single sheet of material that extends continuously around the outer surface of frame 102.

[0167] The cells 110, defined by interconnected struts 108, define cell openings 112. While some of the cell openings 112 can optionally be covered by the inner skirt and / or the outer skirt, at least a portion of the cell openings 112 can remain uncovered, such as cell openings 112 which are closer to the outflow end 106 of the prosthetic valve.

[0168] 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.

[0169] 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.

[0170] 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 optionally be implanted inside a previously implanted mechanically expandable or self-expandable host valve 100a.

[0171] 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 114c). 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.

[0172] 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 theSTJ 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.

[0173] 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.

[0174] 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.

[0175] 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.

[0176] 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 implantationof 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.

[0177] Fig. 4 illustrates an exemplary tissue perforation apparatus 200. Fig. 5 shows a perspective sectional view of a distal portion of the tissue penetration apparatus of Fig. 4. The tissue perforation apparatus 200 includes a delivery catheter 208 attached to a handle 202 and extending distally therefrom. The delivery catheter 206 defines a delivery catheter lumen 208 and has a delivery catheter distal end portion 212 terminating at a distal end 214 which can optionally be, in some examples, an atraumatic distal end 214, such as by being rounded and / or being curved radially inwards, or otherwise formed to include an outer surface tapering in the distal direction.

[0178] The tissue perforation apparatus 200 further includes a hollow needle 218 and an anchor device 237 through which the needle 218 can extend. The needle 218 comprises a needle head 222 and a needle shaft 228 extending proximally from the needle head 222, collectively defining a needle lumen 220 through which a guidewire can optionally extend. The needle head 222 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 222 can optionally define an angled surface 224 terminating at a sharp needle tip 226 configured to facilitate piercing the host leaflet 10 when the needle 218 is pressed thereagainst.

[0179] In some examples, at least a portion of the needle shaft 228 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 228, such as a distal portion 230 thereof, is shown to include a plurality of circumferential slits 232 axially spaced from each other, so as to form circumferential bands separating between adjacent circumferential slits 232, with axially extending connecting portions connecting adjacent bands. Two adjacent circumferential bands can optionally be connected by a plurality of angularly spaced connecting portions defined between ends of corresponding circumferential slits 232. In such arrangements, the slitted part of the needle shaft 228, such as the distal portion 230, exhibits sufficient flexibility to allow it to flex as it is pushed through a tortuous pathway withoutkinking or buckling, and / or to bend when passed through bent portions of the vasculature and / or through bends of a catheter is extends through.

[0180] While a specific pattern is illustrated in Figs. 4-5, which can optionally be a laser cut pattern, it is to be understood that the pattern of slits 232 and / or the size of the slits 232 and / or axial distances between the slits 232 can optionally vary along the length of the corresponding slitted part of the needle shaft 228 in order to vary stiffness of the slitted part of the needle shaft 228 along its length. For example, the axial distance between adjacent slits 232 can optionally decrease from the proximal end to the distal end of the slitted part of the needle shaft 228 to provide greater stiffness near the proximal end and greater flexibility near the distal end of the needle shaft 228.

[0181] In some examples, the slitted part of the needle shaft 228 can optionally extend along the entire length of the needle shaft 228 or at least a significant portion of a length thereof. Optionally, the needle shaft 228 can include a distal portion 230 that includes slits, such as slits 232, and a proximal portion 234 extending proximally from the distal portion 230, which can be devoid of slits, as illustrated in Fig. 5. In some examples, the distal portion 230 and the proximal portion 234 of the needle shaft 228 are separate components that can optionally be affixed to each other, and may be made from similar or different materials. For example, a laser-cut metallic tube that includes slits 232 can optionally be used to form the distal portion 230, while the proximal portion 234 can optionally be made of a polymeric material. The distal portion 230 can allow for increased flexibility along a distal part of the needle 218, 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 234, devoid of such slits, may be less flexible than the distal portion 230, yet flexible enough to allow it to passively bend along curved portions of the patient's vasculature, for example.

[0182] In some examples, the distal portion 230 extends along less than 50% of the length of the entire needle shaft 228. In some examples, the distal portion 230 extends along less than 30% of the length of the entire needle shaft 228. In some examples, the distal portion 230 extends along less than 25% of the length of the entire needle shaft 228. In some examples, the distal portion 230 extends along less than 20% of the length of the entire needle shaft 228. In some examples, the needle head 222 can optionally be continuous with and / or integrally formed with the distal portion 230. For example, when the distal portion 230 is formed from a metallic tube, the needle head 222 can optionally be an integral extension of the tube, together forming a unitary component, while the needle head 222 can optionally be devoid of slits.

[0183] In some implementations of a needle 218, the length of the needle shaft 228 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 230 of the needle shaft 228 to be formed as a hypotube, while the optionally longer proximal portion 234 is made of a polymeric material, can advantageously reduce manufacturing costs. The proximal portion 234 can optionally be affixed, at its distal end, to a proximal end of the distal portion 230, by any method known in the art such as gluing, overmolding, and the like.

[0184] While the needle shaft 228 is shown in the example illustrated in Fig. 5 to be formed of a distal portion 230 that includes slits 232, and a proximal portion 234 devoid of slits, it is to be understood any exemplary needle shaft 228 disclosed herein can optionally 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 228.

[0185] The anchor device 237 of apparatus 200 includes a helical anchor head 238 which is attached, directly or via one or more intermediate components, to a distal end portion 247 of an anchor shaft 244. The helical anchor head 238 defines an anchor channel 239 and has a sharp anchor tip 240 configured to allow it to engage and penetrate a target tissue, such as a host leaflet 10 of a host valvular structure. Optionally, the helical anchor head 238 can be used in combination with the needle 218 which can extend through the anchor channel 239 towards and through a host leaflet 10, for modifying the host leaflet 10. The anchor shaft 244 can optionally extend through the delivery catheter lumen 210. Optionally, the delivery catheter 208 and the anchor shaft 244 can be configured to be axially movable relative to each other. For example, a distally oriented movement of the anchor shaft 244 relative to the delivery catheter 208 can optionally expose the helical anchor head 238 from the delivery catheter 208. The terms "helical anchor head 238" and "anchor head 238", as used herein, are interchangeable.

[0186] The anchor shaft 244 can optionally be a torque shaft, configured to be movable rotatably relative to a central axis thereof and / or rotatable relative to another shaft of the apparatus 200, such as relative to the delivery catheter 208. The anchor head 238 is affixed, directly or via one or more intermediate components, to the anchor shaft 244, such that rotation of the anchor shaft 244 effects rotation of the anchor head 238 therewith. The anchor shaft 244 defines an anchor shaft lumen 246 which is in fluid communications with the anchor channel 239. In some examples, at least a portion of the anchor shaft 244 is formed as a hypotube,configured to increase flexibility thereof. In some examples, at least a portion of the anchor shaft 244 comprises a helical hollow strand (HHS) tube.

[0187] The proximal ends of the delivery catheter 208, the anchor shaft 244 and the needle shaft 218 extend into and are coupled to the handle 202 of apparatus 200. During delivery through the patient's vasculature, the handle 202 can be maneuvered by an operator (for example, a clinician or a surgeon) to control movement of components of the apparatus 200, such as the anchor shaft 244 and the needle shaft 228. The terms "tissue perforation apparatus 200" and "apparatus 200", as used herein, are interchangeable.

[0188] In some examples, an anchor head 238 can optionally be a tube-cut anchor head. Manufacturing of a tube-cut anchor head 238 can employ any suitable cutting method, such as, but not limited to, laser cutting, water-jet cutting, plasma cutting, and the like. The anchor head 238 can optionally define one or more helical turns 242 continuously extending between a proximal end of the anchor head 238 and the anchor tip 240. In some examples, the anchor head can optionally be formed from a rounded wire shaped to form the helical turns 242. Sharpening the anchor tip 240 can employ grinding or any other suitable sharpening method.

[0189] The handle 202 includes first handle portion 204 and a second handle portion 206 which are separable from each other. An engagement knob 320 of the handle 202 is configured to control a lock and release mechanism that can either maintain the two portions 204 and 206 coupled to each other, or to release one from the other so as to allow separation between the first handle portion 204 and the second handle portion 206.

[0190] 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, a handle 202a, illustrated in Figs. 6A-13, is an exemplary implementation of handle 202, and thus can include any of the features described for handle 202 throughout the current disclosure, except that the handle 202aincludes a plurality of locking balls 346 configured to maintain or release engagement between the first handle portion 204 and the second handle portion 206.

[0191] Fig. 6A is a cross-sectional view of an exemplary handle 202aalong a first axially- extending cutting plane. Fig. 6B is a cross-sectional view of the handle 202aof Fig. 6A along a second axially-extending cutting plane which is orthogonal to the first cutting plane of Fig. 6A. Fig. 7 is a cross-sectional view along line 7-7 of Fig. 6B. Fig. 8A is a partial cross-sectional view of the handle 202ain a released configuration thereof, showing the first handle portion 204aand the second handle portion 206aseparated from each other. Fig. 8B is a partial cross- sectional view of the handle 202ain a connected configuration thereof, showing the first handle portion 204aand the second handle portion 206aconnected to each other. Fig. 9A is a partial perspective view of the handle 202aof Fig. 8B. Fig. 9B is a partial perspective view of the handle 202aof Fig. 9A, wherein the engagement knob 320ais shown with partial transparency. Figs. 10A and 10B are cross-sectional views taken along line 10A-10A of Fig. 8B and line 10B-10B of Fig. 8A, respectively. Fig. 11A is a perspective view of an exemplary distal housing 300aof the handle 202a. Fig. 1 IB is a cross-sectional view taken along line 11B-11B of Fig. 11 A. Figs. 12A and 12B are cross-sectional view taken along line 12-12 of Fig. 8B, in states that correspond to the position of the engagement knob 320ain Figs. 10 A and 10B, respectively.

[0192] Fig. 13 is an enlarged perspective view of a portion of the handle 202athat includes the engagement knob 320ashown with partial transparency. Fig. 14 shows a cross-sectional view of an exemplary handle 202 having a safety knob 570 shown in an unlocking position thereof. Fig. 15 shows a cross-sectional view of an exemplary handle 202 equipped with flushing ports. Fig. 16A and 16B are isometric views of a rear portion of the handle 202, showing the safety knob in locking and unlocking positions thereof, respectively. Figs. 17A and 17B are isometric views of a rear portion of the handle 202 corresponding to the safety knob positions of Figs. 16A and 16B, with the proximal housing 500 of the handle 202 removed from view to expose some components of the second handle portion 206. Figs. 6A-17B are described herein together.

[0193] The first handle portion 204 comprises a distal housing 300, and the second handle portion 206 comprises a proximal housing 500. In some examples, the first handle portion 204 can optionally include a distal support body 350 disposed inside the housing 300. The delivery catheter 208 comprises a delivery catheter proximal end portion 216 which is affixed to the first handle portion 204. In some examples, the delivery catheter proximal end portion 216 is affixed to the distal housing 300. In some examples, the delivery catheter proximal end portion 216 is affixed to the distal support body 350. In some examples, the delivery catheter 208 extends through an axial channel 354 of the distal support body 350. In some examples, thedelivery catheter proximal end portion 216 is affixed to the axial channel 354 of the distal support body 350. The delivery catheter proximal end portion 216 can optionally be rigidly coupled to a component of the first handle portion 204, such as the distal housing 300 and / or the distal support body 350, using any suitable method, such as gluing, welding, clamping, threads, and the like.

[0194] The anchor shaft 244 extends through the delivery catheter lumen 210 into the handle 202 and towards the second handle portion 206. In some examples, the anchor shaft 244 extends proximally from the delivery catheter 208, such as proximally from the delivery catheter proximal end portion 216, and comprises an anchor shaft proximal section 248 coupled to the second handle portion 206. The second handle portion 206 comprises an anchor control knob 480 configured to control rotational movement of the anchor shaft 244.

[0195] The needle shaft 228 extends through the anchor shaft lumen 246 into the second handle portion 206. In some examples, the needle shaft 228 extends proximally from the anchor shaft 244, such as proximally from the anchor shaft proximal section 248, and comprises a needle shaft proximal end portion 236 coupled to the second handle portion 206. The second handle portion 206 comprises a needle advancement knob 530 configured to control axial movement of the needle 218.

[0196] In some examples, the first handle portion 204 comprises a valve assembly 370 that can reside inside an internal bore 356 of the distal support body 350, wherein the internal bore 356 can optionally be common with the axial channel 354 of the distal support body 350. The valve assembly 370 comprises a series of valves 372, 378, 384 for sealing around different sized shafts. In some examples, the valve assembly 370 comprises a cross-slit valve 372, a disc valve 378, and a hemostatic valve 384, arranged in series such that the hemostatic valve 384 is distal to the disc valve 378, and such that the disc valve 378 is distal to the cross-slit valve 372. The valve assembly 370 is configured to provide a seal when there is no shaft or other instrument extending therethrough, as well as when several different sizes of shafts pass through the first handle portion 204. For example, the valves 372, 378, 384 can optionally seal against the anchor shaft 244 in the example illustrated in Figs. 6A-6B.

[0197] The cross-slit valve 372 can optionally include a generally semi-spherical portion 374, and an aperture 376 extending through an apex of the semi-spherical portion 374. The disc valve 378 can optionally include a circulatory body portion 380 having an aperture 382 disposed within and extending through a center thereof. The aperture 382 of disc valve 378 is coaxially aligned with the aperture 376 of the cross-slit valve 372. The hemostatic valve 384 can optionally be similar in structure to a duck bill valve, transitioning in the distal directioninto a reduced diameter of a central portion thereof, and include a pair of flaps 386 defining elongated slits 388 extending between distal ends of the flaps 386. In some examples, any of the cross-slit valve 372, the disc valve 378, and the hemostatic valve 384, can optionally comprise or be fabricated from polyisoprene, though other biocompatible resilient materials may be used.

[0198] In some examples, the first handle portion 204 further comprises a rigid retainer 390, which can optionally reside inside the internal bore 356 and secured to the distal support body 350, proximal to the cross-slit valve 370. The cross-slit valve 370 can optionally be abutted, in such examples, against the retainer 390 in a manner that forms a fluid- tight seal therebetween. The retainer 390 defines a central opening 392 aligned with the aperture 376 of the cross-slit valve 372.

[0199] The second handle portion 206 comprises an extension body 400 having a distal section 408, a proximal section 438, and an intermediate section 430 disposed between the distal section 408 and the proximal section 438. The anchor control knob 480 is disposed around the intermediate section 430 of the extension body 400. Thus, the distal section 408 extends distally from the axial position of the anchor control knob 480, and the proximal section 438 extends proximally from the axial position of the anchor control knob 480.

[0200] The extension body 400 further defines an outer surface 402 and an inner surface 404, wherein the inner surface 404 defines the borders of an extension body bore 406 of the extension body 400. The extension body bore 406 can optionally have several bore portions continuous with each other. A extension body 400 of exemplary second handle portion 206 can optionally include a first bore portion 406a (see Fig. 8A) inside the distal section 408, a second bore portion 406b extending proximally from the first bore portion 406a and having a smaller diameter than the first bore portion 406a, a third bore portion 406c extending proximally from the second bore portion 406b, a fourth bore portion 406d extending proximally from the third bore portion 406c and having a smaller diameter than the third bore portion 406c, a fifth bore portion 406e extending proximally from the fourth bore portion 406d and having a smaller diameter than the fourth bore portion 406d, and a sixth bore portion 406f extending proximally from the fifth bore portion 406e and having a larger diameter than the fifth bore portion 406e.

[0201] In some examples, the first bore portion 406 of the extension body 400 is sized to accommodate at least part of the distal support body 350 therein, as shown for example in Figs. 6A-6B and 8B for the engaged state of the handle 202, when the second handle portion 206 is engaged with or coupled to the first handle portion 204.

[0202] The distal section 408 of the extension body 400 is configured to extend into the distal housing 300 of the first handle portion 204 in the engaged state of the handle 202, as illustrated in 6A-6B and 8B, and to be released out of the distal housing 300 in the disengaged state of the handle 202, when the second handle portion 206 is separated or released from the first handle portion 204, as shown for example in Fig. 8A. In some examples, the distal section 408 of the extension body 400 is insertable into a gap formed between an inner surface 304 of the distal housing 300 and an outer surface 352 of the distal support body 350 in the engaged state of the handle 202, such that the outer surface 402 of the distal section 408 of extension body 400 is facing the inner surface 304 of the distal housing 300, and the inner surface 404 of the distal section 408 of extension body 400 is facing the outer surface 352 of the distal support body 350.

[0203] The second handle portion 206 can optionally further include, in some examples, a connector body 450 disposed inside the intermediate section 430 of the extension body 400, and coupled, directly or indirectly, with the anchor shaft 244. In some examples, the coupling between connector body 450 and the anchor shaft 244 can prevent rotational movement of the anchor shaft 244 relative to the second connector body, while allowing rotation movement of the anchor shaft 244 along with the connector body 450. In some examples, the connector body 450 can optionally be attached to the anchor shaft proximal section 248. The connector body 450 can optionally include a distal connector portion 452, a proximal connector portion 456, and an intermediate connector portion 456 disposed between the distal connector portion 452 and the proximal connector portion 456.

[0204] The connector body 450 further defines a connector bore 460 extending therethrough. Optionally, the connector bore 460 can include a distal bore portion 462 and a proximal bore portion 464, wherein the anchor shaft 244, such as along its anchor shaft proximal section 248, can extend into the distal bore portion 462. In some examples, the anchor shaft 244 and / or its anchor shaft proximal section 248 can optionally terminate inside the distal bore portion 462, such that the needle shaft 228 extends proximally therefrom, through the proximal bore portion 464.

[0205] Optionally, an anchor device 237 can further comprise a non-circular flange 252 at the anchor shaft proximal section 248, wherein the non-circular flange 252 can have a non-circular profile that is adapted to match with a non-circular profile of the distal bore portion 462. In the example illustrated in Fig. 7, the non-circular flange 252 is shown to define two flats 254, such that when connector body 450 is rotated, the non-circular flange 252 and the anchor shaft 244 rotate in the same direction as the connector body 450. It is to be understood that a non-circularflange 252 that includes two flats 254 is shown by way of illustration and not limitation, and that any other number of flats, or any other non-circular shape of the flange 252 is contemplated.

[0206] In some examples, the non-circular flange 252 is integrally formed with the anchor shaft 244. In some examples, the non-circular flange 252 is provided as a separate component which is rigidly coupled to the anchor shaft 244, such as to anchor shaft proximal section 248, using any suitable method, such as gluing, welding, friction fitting, clamping, and the like. The rigid connection between the non-circular flange 252 and the anchor shaft proximal section 248 will allow the anchor shaft 244 to rotate as the non-circular flange 252 rotates in response to rotation of the anchor control knob 480, as will be described in greater detail below.

[0207] In some examples, the intermediate connector portion 454 can optionally include connector outer gear teeth 470 disposed around a circumference thereof (see Fig. 7). The connector outer gear teeth 470 can optionally be gear teeth which are integrally formed with the connector body 450, as illustrated for example in Fig. 7, or gear teeth of a separate gear that can be disposed around, and attached to, the intermediate connector portion 454. Optionally, the distal connector portion 452 can extend distally from the axial position of the connector outer gear teeth 470, and the proximal connector portion 456 can extend proximally from the axial position of the connector outer gear teeth 470.

[0208] As shown in Figs. 6B and 7, the intermediate section 430 of the extension body 400 can optionally further include radial bores 432 which are axially aligned with the third bore portion 406c and radially extend between the third bore portion 406c and the anchor control knob 480. The second handle portion 206 can optionally include idler gears 490 residing inside the radial bores 432.

[0209] In some examples, the anchor control knob 480 can include inner gear teeth 484. Optionally, the inner gear teeth 484 can be integrally formed with the anchor control knob 480, defined as part of an inner surface 482 of the anchor control knob 480, as illustrated for example in Fig. 7, or they can be inner teeth of a separate inner gear that can be disposed inside, and attached to the inner surface 482 of, the anchor control knob 480.

[0210] As further illustrated in Fig. 7, the inner gear teeth 484 of the anchor control knob 480 are meshed with the outer gear teeth 494 of the idler gears 490. The outer gear teeth 494 of the idler gears 490 are in turn meshed with the connector outer gear teeth 470 of the connector body 450. Each of the idler gears 490 can optionally comprise a central bore 492 through which extends a support shaft 474 around which the idler gear 490 can rotate.

[0211] In use, when the anchor control knob 480 is rotated, such as by a user of the handle 202, it rotates the idler gears 490 which are meshed therewith, which in turn rotate the connector body 450. The connector body 450 is affixed to the anchor shaft 244, causing it to rotate therewith. As mentioned above, the anchor shaft 244 is a torque transmitting shaft, transmitting the rotational movement to the helical anchor head 238 at the distal end of the anchor device 237. The number of meshed gear teeth and the size and number of idler gears 490 can be selected according to any desired transmission ratio between the anchor control knob 480 and the helical anchor head 238. While two idler gears 490 are shown for illustrative purpose, it is to be understood that any number of idler gears may be used to translate rotational movement of the anchor control knob 480 to the connector body 450. In some examples, the idler gears 490 may be omitted and the connector outer gear teeth 470 of the connector body 450 can optionally be designed to directly contact and mesh with inner gear teeth 484 of the anchor control knob 480, which will result in a 1:1 transmission ratio.

[0212] The intermediate connector portion 454 can optionally be positioned inside the third bore portion 406c, to allow it to interact with the idler gears 490, for example. Optionally, the distal connector portion 452 can extend through the second bore portion 406b, and in some examples, can further extend into the first bore portion 406a. The proximal connector portion 456 can optionally extend into the fourth bore portion 406d.

[0213] The support shafts 474 extending through the idler gears 490 can optionally distally extend, through axial bores 434 formed in the intermediate section 430 of the proximal body 400, from a plate 472 disposed between the intermediate section 430 of the extension body 400 and a distal end 536 of the needle advancement knob 530. The plate can optionally define a central opening (not annotated) aligned with the fifth bore portion 406e, through which the needle shaft 228 can extend.

[0214] The second handle portion 206 can optionally include, in some examples, a clicking mechanism that provides tactile and / or audible feedback in response to rotation of the anchor control knob 480. As shown in Fig. 6B for example, the tactile and / or audible feedback mechanism can optionally include one or more biased detent elements 476, which are outwardly biased, in a radial direction, by detent springs 478 residing in sockets 436 of the intermediate section 430 of extension body 400. The biased detent elements 476 can optionally be in the form of beads, balls, dimples, and the like. The inner surface 482 of the anchor control knob 480 can optionally be provided with a series of notches 486 into which the detent elements 476 are biased. The notches 486 can optionally be formed along a portion of the inner surface 482 that is proximal to the inner gear teeth 484. Optionally, a plurality of notches 486 can beaxially aligned with each corresponding biased detent element 476, and can be circumferentially spaced from each other. When the anchor control knob 480 rotates and the biased detent elements 476 move out of and into corresponding notches 410, a clicking sound can be produced to provide an audible feedback, or vibration caused by the detent springs 478 and movement of the detent elements 476 can provide tactile feedback for a user.

[0215] The second handle portion 206 can optionally include a needle displacement mechanism controlled by needle advancement knob 530 to displace the needle 218 relative to the handle 202 and / or relative to the anchor device 237. In some examples, the second handle portion 206 can optionally include a lead member 532 that can be received within a portion of the proximal housing 500. A distal end portion of the lead member 532 can optionally protrude from a distal end 506 of the proximal housing 500. In some examples, the needle advancement knob 530 can optionally be attached to or integrally formed with the distal end portion of the lead member 532 such that rotation of the needle advancement knob 530 results in rotation of the lead member 532.

[0216] The lead member 532 includes a lead bore 542 with a lead internal thread 534. The proximal section 438 of extension body 400 can optionally include an axial guide extension 440 which is disposed within the lead bore 542 and is coaxial with the lead bore 542. The axial guide extension 440, which is part of the extension body 400, is axially and rotationally fixed relative to the proximal housing 500 of the second handle portion 206, which means that the axial guide extension 440 does not rotate when the lead member 532 is rotated. The sixth bore portion 406f, which can optionally have a substantially tubular profile, extends through the axial guide extension 440, and two guide slots 444 extend radially outward from the sixth bore portion 406f toward lead internal thread 534 in opposite directions. The sixth bore portion 406f and guide slots 444 extend axially along the length of the axial guide extension 440.

[0217] The second handle portion 206 further comprises a carriage 550 having a carriage head 552 disposed within the axial guide extension 440. In some examples, the carriage 550 can optionally further comprise a rear port 556 extending proximally from the carriage head 552. The carriage head 552 has a head central portion 562 and two head radial projections 564 extending radially outward from the head central portion 562 in opposite directions and toward the lead internal thread 534. Optionally, the head central portion 562 can be formed and dimensioned to be situated within the sixth bore portion 406f extending through the axial guide extension 440, while the axial guide slots 444 can be dimensioned to accommodate the respective head radial projections 564.

[0218] The outer surface of each head radial projection 564 comprises a carriage outer thread 554 that engages the lead internal thread 534 through the axial guide slots 444. Thus, rotation of the lead member 532 by rotating the needle advancement knob 530 results in translation of the carriage 550 along the axial guide extension 440. The axial guide extension 440 ensures that the translation of the carriage 550 will occur only along the axial direction of the handle 202, preventing rotational movement of the carriage 550.

[0219] The carriage 550 defines a carriage bore 558 into which a proximal end portion 236 of the needle shaft 228 extends. The needle shaft proximal end portion 236 is rigidly attached to the carriage 550 using any suitable method, such as gluing, welding, clamping, threads, and the like. The rigid connection between the needle shaft proximal end portion 236 and the carriage 550 will allow the needle shaft 228 to move axially as the carriage 550 moves axially in response to rotation of the needle advancement knob 530 and the lead member 532, as will be described in greater detail below.

[0220] In some examples, the axial guide extension 440 can optionally include a radial opening 442 leading to a side opening 560 extending through the carriage head 552 towards the carriage bore 558, as shown for example in Fig. 6A. During an assembly procedure of the handle 202, the needle shaft proximal end portion 236 can optionally be inserted into the carriage bore 558, along a length sufficient to expose part of the needle shaft proximal end portion 236 to the side opening 560. This can provide access, through the opening 442 of the axial guide extension 440 and the side opening 560 of the carriage head 552, to a part of the needle shaft proximal end portion 236 extending through the carriage 550, which can be used to affix the needle shaft proximal end portion 236 to the carriage 550. For example, an adherent (e.g., glue) can optionally be delivered through the opening 442 of the axial guide extension 440 and the side opening 560 of the carriage head 552, and applied to the outer surface of the needle shaft proximal end portion 236, so as to rigidly attach it to the carriage 550.

[0221] The length of the lead bore 542, the length of the axial guide extension 440, and / or the length of the carriage head 552 can be selected to provide the desired axial translation range of the needle shaft 228. The number and spacing of the threads in the lead internal thread 534 and the mating threads in the carriage outer threads 554 can be selected to provide the desired proportion between the amount of needle advancement knob 530 rotations and the extent of axial translation of the needle shaft 228.

[0222] In use, rotation of the needle advancement knob 530 in a first direction can optionally advance the needle shaft 228 distally, and rotation of the needle advancement knob 530 in asecond direction that is opposite to the first direction can optionally retract the needle shaft 228 proximally.

[0223] As will be described in greater detail below, the needle head 222 can optionally be maintained in a retracted position relative to the delivery catheter distal end 214 and / or the anchor head 238 during delivery towards the site of treatment, to prevent the needle tip 226 from engaging with surrounding tissues for example. It may be further desirable to maintain the needle head 222 in a retracted position during anchoring of the anchor head to the target tissue, such as a host leaflet 10, to ensure that a pilot puncture formed thereby is performed in a safe and stabilized manner, such as after confirmation of proper securement of the anchor head 238 to the host leaflet 10. For that end, the proximal handle portion 206 can optionally include, in some examples, a safety mechanism configured to prevent unintentional axial displacement of the needle 218.

[0224] In some examples, the handle proximal portion 206 comprises a safety knob 570 configured to move between a locking position, in which rotational movement of the needle displacement knob 530 is prevented, and an unlocking position, in which the needle displacement knob 530 is allowed to rotate, so as to axially displace the needle shaft 228 as described above. The safety knob 570 can be biased to the locking position.

[0225] As shown in Figs. 16A-17B, the safety knob 570 can optionally be axially movable relative to the lead member 532 and / or the proximal housing 500. In some examples, the safety knob 570 can optionally be slidable along a guide slot 516 of the proximal housing 500. The safety knob 570 can optionally include a distal end portion 572, a proximal end portion 574, and a tab 576 that can optionally be in the form of a thumb piece that can be used to proximally pull the safety knob 570 to an unlocking position.

[0226] Optionally, as illustrated in Figs. 6B and 14, the proximal housing 500 can include a fixed magnet 514 and the safety knob 570 can include a knob magnet 578 aligned with the fixed magnet 514. The fixed magnet 514 can optionally be situated, in some examples, in a radial extension 512 of the proximal housing 500. The knob magnet 578 can optionally be situated, in some examples, in the distal end portion 572 of the safety knob 570. In a free state of the safety knob 570, the knob magnet 578 is magnetically attracted to the fixed magnet 514, as shown in Fig. 6B, biasing the safety knob 570 to a distal locking position. Pulling the safety knob 570 rearward at a force that exceed the magnetic attraction between the magnets, moves the safety knob 570 proximally to an unlocking position, separating between the magnets as shown in Fig. 14.

[0227] The lead member 532 can optionally include a recess 540 formed at a proximal end portion 538 thereof, aligned with and exposed to the guide slot 516 of the proximal housing 500. In the locking position of the safety knob 570, shown in Figs. 6B, 16A and 17A, for example, the distally biased state of the safety knob 570 positions its radial protrusion 580 inside the recess 540 of the lead member 532, which prevents rotation of the lead member 532 and the needle advancement knob 530 attached thereto. Thus, as long as the safety knob 570 is maintained in its biased locking position, the needle 218 cannot be axially displaced relative to the anchor device 237, for example.

[0228] When axial displacement of the needle 218 is desired, the safety knob 570 can optionally be proximally pulled to the unlocking position shown in Figs. 14, 16B and 17B, for example, which moves the radial protrusion 580 of the safety knob 570 away from the recess 540 of the lead member 532, and optionally into and / or through a wall recess 518 formed in a proximal wall portion 510 at a proximal end 508 of the proximal housing 500, wherein the wall recess 518 can optionally be aligned with, and positioned proximally to, the recess 540 of the lead member 532. With the radial protrusion 580 of the safety knob 570 no longer residing in the recess 540 of the lead member 532, rotational movement thereof is allowed, for example by rotating the needle advancement knob 530 to axially displace the needle 218. When axial displacement of the needle 218 is no longer required, the safety knob 570 can optionally be released and allowed to return to its biased locking position.

[0229] Optionally, the proximal wall portion 510 can further define a proximal shoulder 520, against which a stopper 582 extending radially inwards from the proximal end portion 574 of the safety knob, and optionally from the radial protrusion 580, can abut. The stopper 582 can optionally be in the form of a pin or other type of extension that terminates radially inwards (e.g., away from) the inner end of the radial protrusion, and is movable along the wall recess 518. As shown for example in Fig. 14, proximal pulling of the safety knob 570 is allowed up to the point at which the stopper 582 hits against the proximal shoulder 520 of the proximal wall portion 510 of the proximal housing 500, which prevents further proximally-oriented movement of the safety knob 570, thus limiting the axial translation of the safety knob 570 in the proximal direction.

[0230] The guide slot 516 extends distally from the proximal end 508 of the proximal housing 500, and can optionally be common with the wall recess 518. The guide slot 516 is shown to extend all the way to the distal end 506 of the proximal housing 500 for illustrative purpose only, and it is to be understood that in some examples, the guide slot 516 can optionally terminate proximal to the distal end 506 of the proximal housing 500.

[0231] The guide slot 516 extends radially inwards from the outer surface 502 of the proximal housing 500. The guide slot 516 is shown to extend radially from the outer surface 502 to the inner surface 504 of the proximal housing 500, extending through the entire thickness of the proximal housing 500 along its entire length, for illustrative purpose only, and it is to be understood that in some example, the guide slot 516 can optionally terminate radially outward to the inner surface 504 of the proximal housing 500, at least along a portion thereof which is distal to the recess 540 of the lead member 532.

[0232] While magnets 514, 578 are illustrated and described as biasing means of the safety knob 570, it is to be understood that other biasing members can optionally be used to bias the safety knob 570 to a distal locking position, such as, for example, springs (e.g., compression springs).

[0233] In some examples, the proximal wall portion 510 can optionally further include a rear opening 522 through which a rear port 556 of the carriage 550 can extend. The rear port 556 can optionally be, in some examples, partially exposed through the rear opening 522 of the proximal housing 500. The carriage bore 558 can optionally be exposed at the proximal end of the rear port 556, through which a portion of a guidewire can extend, into (or out of) the needle lumen 220.

[0234] The handle 202 can further include, in some examples, seal members such as O-rings to provide seals between components of the handle 202 and shafts extending therethrough. For example, the second handle portion 206 can optionally include an O-ring 544a (see Fig. 15), optionally around a portion of the needle shaft 228 extending through the fifth bore portion 406e, to provide a seal around the exterior of the needle shaft 228. The second handle portion 206 can optionally further include, in some examples, an O-ring 544b (see Fig. 15), optionally positioned inside an annular recess 458b of the proximal connector portion 456, to provide a seal between the proximal connector portion 456 and the intermediate section 430 of the extension body 400.

[0235] In some examples, the second handle portion 206 can optionally further include a rear flushing port 398. Optionally, the rear flushing port 398 can be a flexible tube with an internal conduit, and can extend from outside the proximal housing 500, through a flushing opening 524 that can be formed at the proximal wall portion 510 of the proximal housing 500, and into a flushing passageway 446 formed inside the second handle portion 206. In the example illustrated in Fig. 15, the flushing port 398 can optionally be in fluid communication with a first flushing passageway portion 446a extending axially through the axial guide extension 440, which further extends to a second flushing passageway portion 446b extending radially throughthe intermediate section 430 of the extension body 400, leading to the extension body bore 406, such as to the fourth bore portion 406d.

[0236] A connector, such as a Luer connector of a stopcock, can optionally be provided on the end of the rear flushing port 398 that is disposed outside the second handle portion 206 (as shown in Fig. 15). Fluid can optionally be supplied into the fourth bore portion 406d through the rear flushing port 398 and the flushing passageway 446. This fluid can optionally enter into the space between the needle shaft 228 and the anchor shaft 244, allowing flushing therebetween.

[0237] In some examples, the first handle portion 204 can optionally further include a front flushing port 396. Optionally, the front flushing port 396 can be a flexible tube with an internal conduit, and can extend from outside the distal housing 300, through a flushing opening 318 of the distal housing 300, and into a flushing passageway 358 formed inside the distal support body 350. In the example illustrated in Fig. 8B, the flushing port 396 can optionally be in fluid communication with the flushing passageway 358, leading to the internal bore 356. A connector, such as a Luer connector of a stopcock, can optionally be provided on the end of the front flushing port 396 that is disposed outside the first handle portion 204 (as shown in Fig. 15). Fluid can optionally be supplied into the internal bore 356 through the front flushing port 396 and the flushing passageway 358. This fluid can optionally enter, via axial channel 354, into the space between the delivery catheter 208 and the anchor shaft 244, allowing flushing therebetween.

[0238] As mentioned above, an exemplary handle 202 of the current disclosure is configured to be in a connected configuration, defined as a configuration in which the first handle portion 204 and the second handle portion 206 are connected to each other, and a released configuration, defines as a configuration in which the second handle portion 206 is released or disconnected from the first handle portion 204. Stated otherwise, the second handle portion 206 is releasably coupled to the first handle portion 204 in the connected configuration.

[0239] An exemplary handle 202aincludes a lock and release mechanism based on locking balls 346. The first handle portion 204aof exemplary handle 202acomprises a plurality of locking balls 346 configured to engage with notches 410 of the second handle portion 206a. The locking balls 346 extend through radial holes 308 of the distal housing 300a, and are radially bound, in the connected configuration of handle 202a, between an inner surface 324 of the engagement knob 320aand an outer surface 402 of the distal section 408aof extension body 400a.

[0240] In some examples, a plurality of locking balls 346 can optionally be axially aligned with each other, and circumferentially spaced from each other. The locking balls 346 can be equally or unequally spaced from each other around the circumference of the distal housing 300a.

[0241] The distal section 408aof extension body 400acan optionally have a plurality of notches 410 formed along its outer surface 402. In some examples, the notches 410 can optionally be arranged in notch groups 412. Each notch group 412, such as notch group 412a or notch group 412b shown in Fig. 9 A for example, can optionally include a plurality of notches 410 which are axially aligned with each other and circumferentially spaced from each other. The number of notches 410 and their circumferential positions around the distal section 408acan optionally match the number and circumferential positions of locking balls 346. A plurality of notch groups 412 can optionally be serially positioned at different axial positions along the length of the distal section 408aof extension body 400a, such that the corresponding notches 410 of the notch groups 412 are circumferentially aligned.

[0242] As illustrated in Fig. 1 IB, each radial hole 308 in which a locking ball 346 resides, can optionally include a cylindrical portion 310 exposed at the outer surface 302 of the distal housing 300, having a diameter that can be similar to, or slightly greater than, the diameter of the locking ball 346, and an inner phase 312 that tapers towards the inner surface 304 of the distal housing 300, to a diameter which is smaller than that of the locking ball 346. In a free state of a locking ball 346, when the locking ball 346 is not forcibly pushed radially inwards, the inner phase 312 biases the locking ball 346 radially away from the inner surface 304 of the distal housing 300.

[0243] Figs. 10A and 10B show cross-sectional views across the plane of the locking balls 346 in connected and released configurations, respectively, of the handle 202a. The engagement knob 320acan optionally include a series of tapered recessed portions 332 formed at the inner surface 324 engagement knob 320a. The tapered recessed portions 332 are formed at an axial region of the engagement knob 320aaligned with the locking balls 346.

[0244] Each tapered recessed portion 332 extends in a circumferential direction from a narrow region 334, which can optionally be radially at or in close proximity to the outer surface 302 of the distal housing 300a, to a wide region 336, which is radially spaced from the outer surface 302 of the distal housing 300a, such that radial shoulders 338 are formed at the transitions between narrow regions 334 and wide regions 336 of adjacent tapered recessed portions 332. Each tapered recessed portion 332 can optionally have a circumferential length matching the circumferential distance between adjacent locking balls 346.

[0245] When the narrow regions 334 are circumferentially aligned with the locking balls 346, they push the locking balls 346 radially inwards, forcing them into the corresponding notches 410 of distal section 408aof extension body 400a, thereby firmly locking the first handle portion 204aand the second handle portion 206aagainst each other, as shown in Fig. 10A.

[0246] When the engagement knob 320 is rotated, such as in a rotation direction 90 shown in Fig. 10B, so as to align the wide regions 336 with the locking balls 346, the locking balls 346 are free to extend radially outwards, out of notches 410, such that the first handle portion 204aand the second handle portion 206aare no longer locked with each other, and can he axially moved relative to each other.

[0247] The distal housing 300“ can optionally further include, in some examples, a plurality of radial projections 314 extending radially outwards from its outer surface 304, axially aligned with radial protrusions 340 extending radially inwards from the inner surface 324 of the engagement knob 320“. The radial projections 314 and the corresponding radial protrusions 340 are axially offset from the radial holes 308 and locking balls 346. The radial projections 314 and radial protrusions 340 are shown to be distal to the radial holes 308 and locking balls 346 in Figs. 9B, 11A- 1 IB and 13 for illustrative purpose, and it is to be understood that in some examples, the radial projections 314 and radial protrusions 340 can optionally be proximal to the radial holes 308 and locking balls 346.

[0248] Figs. 12A and 12B show cross-sectional views across the plane of the radial projections 314 and radial protrusions 340 in connected and released configurations of the handle 202“, corresponding to the states shown in Figs. 10A and 10B, respectively. Each radial protrusions 340 is circumferentially movable between two adjacent radial projections 314. For example, in the connected configuration illustrated in Fig. 12A, radial protrusion 340a is shown to abut radial projection 314a, which prevents rotational movement of the engagement knob 320“ in a rotational direction opposite to direction 90 beyond the illustrated position. When the engagement know 320“ is rotated in direction 90, as shown in Fig. 12B, the radial protrusion 340a is circumferentially moved until it reaches the following radial projection 314b, at which point the engagement knob 320“ is prevented from being rotated further in the same direction.

[0249] Thus, the circumferential positions of the radial projections 314 are set to limit rotational movement of the engagement knob 320“ between positions corresponding to connected and released configurations, as illustrated in Figs. 10A and 10B, respectively.

[0250] The engagement knob 320“ can optionally include visual indicia 326 on its outer surface, for indicating locked or unlocked states of the handle 202“. The distal housing 300“ can optionally include a marker 306 on it outer surface 302 for marking the current indicia 326,such that alignment of a first indicia 326a (see Fig. 9A, for example) with the marker 306 can optionally represent a locked state as described above with respect to Fig. 10A, while alignment of a second indicia 326b with the marker 306 can optionally represent an unlocked state, as described above with respect to Fig. 10B.

[0251] In some examples, engagement knob 320a, configured to rotate around distal housing 300a, is coupled thereto by a pin 344. Optionally, as illustrated in Fig. 13 for example, an annular recess 316 can be formed along the outer surface 302 of the distal housing 300a, and the engagement knob 320acan include at least one pin bore 330 extending laterally therethrough and axially aligned with the annular recess 316, such that a central region of the pin bore 330 is exposed to the annular recess 316. A pin 344 inserted into the pin bore 330 has a part thereof passing along the annular recess 316 as shown in Fig. 13, thus connecting the engagement knob 320ato the distal housing 300ain a manner that prevents relative axial movement therebetween, yet allows for rotational movement of the engagement knob 320aaround the annular recess 316 of distal housing 300a. The pin 344 can optionally be retained inside pin bore 330 by any appropriate method, including friction fitting, as well as capping with additional end caps (not shown) the open ends of pin bores 330.

[0252] While shown and described with respect to attachment of an engagement knob 320ato the distal housing 300a, it is to be understood that pins 344 can optionally be similarly utilized to couple other components of the handle 202 configured to rotationally move relative to other structures or components of the handle 202. For example, a connector flange 469 of the connector body 450 can optionally include an annular recess 458a, and pins 344 can optionally be similarly used to rotatably connect the flange 469 of the connector body 450 to the intermediate section 430 of extension body 400.

[0253] When the second handle portion 206ais separated and spaced away from the first handle portion 204a, as illustrated, for example, in Fig. 8A, attachment can optionally be performed by insertion of the distal section 408aof extension body 400ainto the gap defined between the distal support body 350aand the distal housing 300a. In order to align the notches 410 with the locking balls 346, the distal support body 350acan optionally have, in some examples, axial alignment projections 360 projecting radially outwards, configured to guide complementary axial alignment recesses 414 of the distal section 408aof extension body 400a, as illustrated in Figs. 10A-10B and 12A-12B.

[0254] When the distal section 408aof extension body 400ais situated inside the distal housing 300a, the engagement knob 320acan optionally be rotated to firmly lock the first handle portion204aand the second handle portion 206ato each other, as described above with respect to Fig. 10 A for example.

[0255] Certain stages of utilization of a tissue perforation apparatus 200 may require axial displacement of the anchor device 237 and needle 218 relative to the delivery catheter 208, for example in order to expose at least a portion of the anchor head 238 out of the delivery catheter lumen 210 when approaching a target host leaflet 10. In such cases, the engagement knob 320acan optionally be rotated in a direction configured to release engagement between the handle portion 204aand 206a, as described above with respect to Fig. 10B for example, and the second handle portion 206acan optionally be axially moved relative to the first handle portion 204a(or the first handle portion 204acan be moved relative to the second handle portion 206a) until a desired axial position therebetween is reached, in which case the locking balls 346 can optionally be axially aligned with a different notch group 412 corresponding to the selected axial position, after which the engagement knob 320acan optionally be rotated again in a direction that locks both handle portions 204a, 206aagainst each other.

[0256] In some cases, follow up stages in a method of implantation of a guest prosthetic valve 100 inside a host valvular structure 12, as will be described in greater detail below, may require complete removal of the second handle portion 206 while the first handle portion 204 can optionally be utilized in combination with another apparatus. Optionally, in such cases, the engagement knob 320acan be rotated in a direction configured to release engagement between the handle portion 204aand 206a, after which the second handle portion 206acan be completely pulled away from the first handle portion 204a.

[0257] Fig. 18 is a cross sectional view of an exemplary handle 202b, which is similar to any example described herein for handle 202a, except that the handle 202brelies on a threaded engagement between the first handle portion 204band the second handle portion 206b, and includes a safety latch 418 configured to serve as a lock and release mechanism, instead of the locking balls of handle 202a. Fig. 19 is a perspective view of the handle 202b, showing the first handle portion 204band the second handle portion 206bseparated from each other. Figs. 20A and 20B are cross-sectional views of a distal portion of the handle 202b, with the safety latch 418 shown in locked and unlocked states thereof, respectively. Fig. 20C is a cross-sectional view of a distal portion of the handle 202bof Fig. 20B, showing the first handle portion 204band the second handle portion 206bseparated from each other. Figs. 18-20C are described herein together.

[0258] Optionally, the engagement knob 320hof the first handle portion 204ncan include a knob internal thread 342 along its inner surface 304, and the distal section 408bof extensionbody 400bcan include a body outer thread 416, along at least part of its outer surface 402, configured to engage with the knob internal thread 342 when the distal section 408bof extension body 400bis inserted into distal housing 300b. In some examples, the engagement knob 320bincludes a lead body 328 that can optionally be received within a portion of the distal housing 300b, and defines the inner surface 304 of the engagement knob 320bthat includes the knob internal thread 342.

[0259] In some examples, the engagement knob 320bcan optionally be attached to or integrally formed with the proximal end portion of the lead body 328 such that rotation of the engagement knob 320bresults in rotation of the lead body 328. The additional length of the lead body 328 can provide for increased length along which the knob internal thread 342 can be formed, so as to ensure improved threaded engagement between the lead body 328 of engagement knob 320band the distal section 408bof extension body 400b.

[0260] The second handle portion 206bis further shown to include a safety latch 418, positioned at the distal section 408bof extension body 400b. The safety latch 418 can optionally include a pressable proximal latch portion 420, and a distal latch portion 422 extending distally from the proximal latch portion 420. Optionally, the safety latch 418 can reside in a cut-out formed across the wall thickness of the distal section 408bof extension body 400b, and can have outer and inner surfaces which can be substantially flush with the outer surface 402 and the inner surface 404 of the distal section 408bof extension body 400b. Optionally, the body outer thread 416 can be formed along a circumferential portion of the distal section 408bthat does not include the safety latch 418, while the portion of the distal section 408bthat includes the safety latch 418 can remain devoid of any thread.

[0261] The distal latch portion 422 can optionally be connected to the distal section 408bof extension body 400bby a hinge 424, as shown for example in Fig. 19, configured to allow pivotable movement of the safety latch 418 about the hinge 424. In some examples, a latch spring 426 (or any other suitable biasing member) can optionally bias the safety latch 418 to a locked state thereof. For example, Figs. 19 and 20A show a latch spring 426, which can optionally be a compression spring, axially extending between the distal latch portion 422 and a portion of the distal section 408bof extension body 400bthat can optionally be distal to the safety latch 418, configured to bias the safety latch, in a free state thereof, to the locked state illustrated in Fig. 19 and 20A.

[0262] The distal latch portion 422 can optionally further include a tooth 428 protruding radially inwards. When the distal section 408bof extension body 400bis inserted from a separated position of the second handle portion 206bshown in Fig. 19, into the distal housing300b, the tooth 428 of the safety latch 418 snaps into a recess 362 formed in a proximal body portion 366 of the distal support body 350b, as shown in Fig. 20A. The recess 362 extends from the outer surface 352 of the distal support body 350b, and defines a proximal radial step 364 against which the tooth 428 abuts, thus preventing the second handle portion 206bfrom being proximally pulled and released from the first handle portion 204bin the locked state shown in Fig. 20A.

[0263] When axial displacement of the anchor device 237 and needle 218 relative to the delivery catheter 208 is desired, the proximal latch portion 420 can optionally be depressed, causing the safety latch 418 to pivot about the hinge 424, raising the tooth 428 out of the recess 362 of the distal support body 350b, thereby moving the safety latch 418 to the unlocked state shown in Fig. 20B for example, such that rotation of the engagement knob 320bin a selected direction can axially move the second handle portion 206brelative to the first handle portion 204b. When the desired axial position is achieved, the safety latch 418 can optionally be released, allowing the latch spring 426 to bias it back to the locked state.

[0264] When complete removal of the second handle portion 206bfrom the first handle portion 204bis desired, the proximal latch portion 420 can optionally be depressed to move the safety latch 418 to the unlocked state as described above with respect to Fig. 20B, after which the second handle portion 206bcan be proximally pulled from the first handle portion 204b, as shown for example in Fig. 20C, optionally by rotating the engagement knob 320bin a direction that translates the second handle portion 206bproximally from the first handle portion 204buntil the distal section 408bof extension body 400bis no longer threaded with the lead body 328 of the engagement knob 320b.

[0265] Fig. 21 shows a proximal end portion of an exemplary anchor device 237b. Figs. 22A and 22B are perspective and front views of an exemplary connector body 450badapted to connect with the anchor device 237bof Fig. 21. Anchor device 237band connector body 450bare exemplary implementations of anchor device 237 and connector body 450, and thus can include any of the features described for anchor device 237 and connector body 450 throughout the current disclosure, except that the anchor device 237bcan optionally be devoid of a noncircular flange 252 configured to be inserted into a complementary non-circular bore portion of a connector body 450, and instead comprises a reinforcement tube 256 configured to facilitate attachment to a connector body 450b. Fig. 23 is a cross-sectional view of a portion of the handle 202 including an anchor device 237bengaged with a connector body 450b. Fig. 24 is a perspective view of an anchor device 237bengaged with a connector body 450b, wherein the connector body 450bis shown with partial transparency. Figs. 25 A and 25B are perspectivesectional and cross-sectional views along line 25-25 of Fig. 23. Figs. 21-25B are described herein together.

[0266] An anchor device 237bcan optionally include a reinforcement tube 256, optionally extending along a proximal end portion 250 of the anchor shaft 244. The reinforcement tube 256 can optionally be rigidly coupled to the anchor shaft proximal end portion 250 using any suitable method, such as gluing, welding, clamping, and the like. In some examples, the length of an anchor shaft proximal end portion 250 covered by the reinforcement tube 256 can optionally be selected to cover at least a portion of the anchor shaft 244 extending from its attachment region to the connector body 450band a distal end of the distal housing 300 in a connected configuration of the handle 202. A relatively long portion along which the reinforcement tube 256 extends can increase engagement with the anchor shaft 244, and relieve some of the stress concentration that can otherwise develop along the proximal part of the anchor shaft 244 torqued during rotation of the anchor control knob 480.

[0267] In some examples, the reinforcement tube 256 is attached (e.g., welded) to the anchor shaft 244 along a relatively elongated continuous length of attachment area (e.g., longer than 2mm. in length). In some examples, the reinforcement tube 256 is attached (e.g., welded) to the anchor shaft 244 along a relatively short attachment line (e.g., less than 2mm. in length). In some examples, the reinforcement tube 256 is attached (e.g., welded) to the anchor shaft 244 by a series of two or more regions of attachment (e.g., welds) that can be optionally axially spaced from each other. In some examples, the anchor shaft 244 extends through a length of the reinforcement tube 256, optionally up to and / or past a proximal end portion 258 of the reinforcement tube 256. In some examples, the reinforcement tube 256 extends proximally from its attachment region (e.g. weld) to the anchor shaft 244, such that the proximal end portion 258 of the reinforcement tube 256 is proximal to the proximal end portion 250 of the anchor shaft 244.

[0268] As shown in Fig. 21, the reinforcement tube 256 can optionally include tube recesses 260 formed as cutouts along its proximal end portion 258. The distal bore portion 462 of connector body 450bcan optionally be cylindrically shaped, having a diameter sized to accept the reinforcement tube 256 therein. The connector body 450bfurther includes radial protrusions 468 that extend into the tube recesses 260. The connector body 450bcan optionally define a radial shoulder or step 466 at the transition between the distal bore portion 462 and the proximal bore portion 464, against which the proximal end of the anchor shaft 244 can be pushed.

[0269] In this manner, rotational movement of the connector body 450b, which can optionally be accomplished in a similar manner to that described above with respect to Fig. 7, for example,will rotationally push the radial protrusions 468 against the sidewalls of the tube recesses 260, facilitating rotation of the reinforcement tube 256 and the anchor shaft 244 affixed thereto in the same rotational direction.

[0270] While anchor device 237band connector body 450bare illustrated in combination with a handle 202bthat includes threadedly engageable handle portions 204b, 206b, it is to be understood that an anchor device 237bincluding a reinforcement tube 256 can be similarly used in combination with a connector body 450bthat can optionally be part of a second handle portion 206a, engageable with a first handle portion 204aby locking balls 346.

[0271] In some examples, the tissue perforation apparatus 200 can optionally be used as part of a stabilized tissue modification system 600. Fig. 26 shows an exemplary stabilized tissue modification system 600, which can optionally include a steerable delivery apparatus 602. A steerable delivery apparatus 602 can optionally include an outer catheter 610, optionally implemented as a steerable catheter. Optionally, the steerable outer catheter 610 can be advanced towards the valvular structure 12 over a guidewire 80, and the delivery catheter 208 can be passed, along with the anchor device 237 and needle 218, through the outer catheter 610, over a guidewire 80, towards the host leaflet 10.

[0272] Optionally, the steerable delivery apparatus 602 can include a handle 604, wherein the outer catheter 610 can extend distally from the handle 604. The handle 604 can be maneuvered to control the outer catheter 610. In some examples, the handle 604 can optionally include a steering mechanism configured to adjust the curvature of the distal end portion of the outer catheter 610. In the illustrated example, the handle 604 can optionally include an adjustment member, such as the illustrated rotatable knob 606a, which in turn is operatively coupled to the proximal end portion of a pull wire (not shown). The pull wire can optionally extend distally from the handle 604 through the outer catheter 610 and has a distal end portion affixed to the outer catheter 610 at or near the distal end of the outer catheter 610. Rotating the knob 606a can optionally increase or decrease the tension in the pull wire, thereby adjusting the curvature of the distal end portion of the outer catheter 610. Further details on steering or flex mechanisms for the delivery apparatus can be found in U.S. Patent No. 9,339,384, which is incorporated by reference herein. The terms "stabilized tissue modification system 600" and "system 600", as used herein, are interchangeable.

[0273] The steerable outer catheter 610 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 610 to navigate it during delivery, afterwhich the delivery catheter 208 can optionally be inserted through a rear port 608 of the handle 604 and advanced through the outer catheter 610.

[0274] Figs. 27A-27F illustrate some steps in a method for utilizing a tissue perforation apparatus 200, optionally extendable through an outer catheter 610 of a system 600, for forming a pilot puncture 50 in a target tissue. An exemplary implementation of the method is illustrated in Figs. 27A-27F, as well as follow up steps for forming a tissue opening illustrated in Figs. 29A-29E, with respect to forming a leaflet opening inside a host leaflet, which can optionally be performed prior to implanting a guest prosthetic valve inside the host valvular structure, as further described below with respect to Figs. 29F-29G for example. The apparatus 200 can optionally 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.

[0275] The distal end portion of the apparatus 200, which can optionally include the atraumatic distal end portion 214 of the delivery catheter 208, is configured to be advanced towards the host leaflet 10, optionally through a pre-inserted steerable outer catheter 610. Positioning the delivery catheter distal end portion 610 relative to the host leaflet 10 may comprise advancing the delivery catheter 208 toward the leaflet over a guidewire 80. The needle 218 can optionally be configured to accommodate a guidewire 80 that can extend through the needle lumen 220.

[0276] During delivery, the anchor head 238 can optionally be retained inside delivery catheter lumen 210, such that the anchor tip 240 is at or proximal to the delivery catheter distal end portion 212, as illustrated in Fig. 27A. This position conceals the sharp tip 240 of the anchor head 238 from the surrounding anatomy, to protect the anatomical structures, as well as the outer catheter 610 through which it can optionally be advanced, from being engaged or punctured by the anchor tip 240 during advancement towards the site of treatment. The needle head 222 can optionally be similarly retained inside the anchor device 237, such that the needle tip 226 is at or proximal to the anchor tip 240. This position conceals the sharp tip 226 of the needle head 222 from the surrounding anatomy and / or outer catheter 610, to similarly protect them from being engaged or punctured by the needle-sharp tip 226 during advancement towards the site of treatment.

[0277] The anchor head 238 can be approximated to the host leaflet 10, and the anchor control knob 480 can optionally be then rotated in a rotational direction that causes the anchor head 238 to engage and penetrate the host leaflet 10, thereby securing the anchor head 238 to host leaflet 10 as shown in Fig. 27B. The tissue material of host leaflet 10 can be retained between successive helical turns 242 of the anchor head 238. In some examples, the delivery shaft distal end 214 can optionally be in contact with, and / or slightly pushed against, the host leaflet 10,prior to rotating the anchor head 238 to screw it into the host leaflet 10, which can stretch and / or flatten the host leaflet 10 to some extent along a plane perpendicular to the axial direction of anchor device 237 and needle 218 advancement, which can increase stability of the leaflet for improved engagement with the anchor head 238 at it is being screwed thereinto.

[0278] Following engagement of the anchor head 238 with the host leaflet 10, the needle 218 should be advanced to puncture the tissue material. For that end, the safety knob 570 can optionally be proximally pulled to its unlocking position, and the needle advancement knob 530 can optionally be rotated in a rotation direction that facilitates distal advancement of the needle 218, causing the needle head 222 to puncture the host leaflet 10 to form a pilot puncture 50 within host leaflet 10, as shown in Fig. 27C.

[0279] An attempt to pass a needle 218 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 238 captures the host leaflet 10 and stabilizes it during formation of a pilot puncture 50 by a needle 218 being pushed against and through the host leaflet 10.

[0280] Once the needle head 222 is positioned, at least partially, past the host leaflet 10, the guidewire 80 can optionally be advanced through the needle lumen 220 to terminate with guidewire tip 82 at a position distal to the pilot puncture 50 of host leaflet 10 as shown in Fig. 27D.

[0281] Subsequent to forming the pilot puncture 50 and optionally advancing the guidewire 80 to extend therethrough, the needle 218 can be optionally retracted, as shown in Fig. 27E, by rotating the needle advancement knob 530, while the safety knob 570 is in the unlocking position, in a counter rotational direction configured to facilitate proximal movement of the needle shaft 228.

[0282] The anchor control knob 480 can be similarly rotated in a counter rotational direction, opposite to the rotational direction used for securing it to the leaflet 10, so as to release the anchor head 238 from the host leaflet 10, which can optionally be similarly retracted by being then axially pulled away from the host leaflet 10, as shown in Fig. 27F, while leaving the guidewire 80 extending through the pilot puncture 50. This can optionally be accomplished by moving the second handle portion 206 proximally to the first handle portion 204 according to any of the methods described above.

[0283] It is to be understood that the order of procedural steps described above with respect to Figs. 27D-27F is merely shown for illustrative purpose, and that in some examples, reverse rotation of the helical anchor head 238 to release it from the host leaflet 10 and retract it can optionally be performed prior to needle 218 retraction. In some examples, counter-rotation of the anchor control knob 480 to release the anchor head 238 from the host leaflet 10 can optionally be performed prior to counter rotation of the needle advancement knob 530 to retract the needle 218, and axial retraction of the anchor head 238 can optionally be performed simultaneously with, or subsequent to, needle 218 retraction.

[0284] In some examples, the guidewire 80 can optionally be advanced simultaneously with advancement of the needle 218 during formation of the pilot puncture 50. In some examples, the guidewire 80 can optionally be advanced to terminate distal to the host leaflet 10 after formation of the pilot puncture 50 by the needle 218, as illustrated in Fig. 27D. In some examples, the guidewire 80 can optionally be advanced through pilot puncture 50 to terminate distal to the host leaflet 10 after retrieval of the needle 218, optionally prior to release of the anchor head 238 from the host leaflet 10.

[0285] In some examples, advancement of the guidewire 80 to position the guidewire tip 82 distal to the pilot puncture 50 can optionally be performed subsequent to counter-rotation of the anchor control knob 480 to release the anchor head 238 from the host leaflet 10 and / or axial retraction of the anchor head 238, while the needle 218 is still positioned inside of pilot puncture 50, after which the needle 218 can optionally be retracted. In some examples, advancement of the guidewire 80 to position the guidewire tip 82 distal to the pilot puncture 50 can optionally be performed after needle 218 retraction while the anchor head 238 is still engaged with the host leaflet 10, after which the anchor head 238 can optionally be released and retracted.

[0286] In some examples, a stabilized tissue modification system 600 can optionally further include a dilation apparatus 620, having a balloon 638 mounted on a balloon catheter 632, as shown in Fig. 28 for example. After formation of the pilot puncture 50, the second handle portion 206 can optionally be released and separated from the first handle portion 204. Optionally, the second handle portion 206, to which the anchor device 237 and the needle 218 are attached, can be then retracted, pulling the anchor device 237 and the needle 218 through the delivery catheter lumen 210 and out of the patient's body, while leaving the outer catheter 610 and the delivery catheter 208 extending therethrough in position, optionally with the guidewire 80 extending through the delivery catheter lumen 210 and the pilot puncture 50.

[0287] Thereafter, the balloon catheter 632 of dilation apparatus 620 can optionally be inserted into the delivery catheter 208 through the first handle portion 204, wherein the valve assembly 370 can seal against the balloon catheter 632. Optionally, the balloon catheter 632 can be then advanced through the delivery catheter lumen 210, optionally over the guidewire 80, towards the host leaflet 10, as shown for example in Fig. 29A.

[0288] The balloon 638 is configured to transition between a radially deflated state, shown for example in Figs. 29A-29C, and a radially inflated state, shown for example in Fig. 29D. The balloon 638 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. 29D and explained in greater detail below.

[0289] An enlarged view of a distal portion of the dilation apparatus 620 is illustrated in Fig. 28, extending out of the delivery catheter 208 for example. Cross-sectional views of the distal portion of the dilation apparatus 620 are further shown throughout Figs. 29A-29E. Optionally, the balloon catheter 632 can define a balloon catheter lumen 634, through which a guidewire 80, and one or more additional shafts of the dilation apparatus 620, can optionally extend. The balloon catheter 632 can optionally extend from a balloon catheter adaptor 642 that includes a first adaptor port 644a configured to receive a guidewire therethrough and a second adaptor port 644b configured to receive fluid from a fluid source.

[0290] The second adaptor port 644b can optionally be fluidly connectable to a fluid source (not shown) for inflating the balloon 638. 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 balloon 638. The inflation fluid source is in fluid communication with the balloon catheter lumen 634, such that fluid from the fluid source can flow through the balloon catheter lumen 634 into balloon 638 to inflate it.

[0291] Optionally, an inflatable balloon 638 of apparatus 620, when 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 balloon, conventionally used for prosthetic- valve expansion procedures, 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 638 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 balloon 638).

[0292] 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 balloon 638 can be inflated is equal to or less than 12 mm. In some examples, the maximum diameter to which the balloon 638 can be inflated is equal to or less than 10 mm. Nevertheless, as mentioned above, in some examples a balloon 638 can be configured to tear a host leaflet 10, in which case the maximum diameter to which the balloon 638 can be inflated can be greater than 12 mm., such as in a range of 20-25 mm.

[0293] Optionally, a dilation apparatus 620 can further include a dilator 622 that can be conical or frustoconical in shape, and include a dilator tapering portion 626 terminating at a dilator distal end 624, and a dilator proximal portion 628 that can be coupled to a dilator shaft 640 that extends proximally therefrom. A dilator lumen 630 continuously extends through the dilator shaft 640 and the dilator 622, open ended at the dilator distal end 624. Attachment of the dilator shaft 640 to the dilator proximal portion 628 can optionally 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 640 can optionally extend through the entire length of the dilator 622, such that a distal end of the dilator shaft 640 is aligned with the dilator distal end 624. In some examples (not illustrated), the dilator shaft 640 is coupled to one or more components, such as collars or other connectors, which are in turn attached to the dilator 622.

[0294] In some examples, the balloon 638 is coupled to a distal end portion of the balloon catheter 632 at its proximal end, while the balloon's distal end can optionally be coupled, directly or indirectly, to another component of the apparatus 620, such as the dilator 622 or dilator shaft 640. In the examples illustrated in Figs. 28-29E, the balloon 638 is shown to be coupled to the dilator proximal portion 628. The dilator proximal portion 628 can optionally include an outer step configured to accommodate the distal end of the balloon 638, such that the outer surface of the balloon 638 can optionally be flush or otherwise relatively continuous with the outer surface of the dilator 622.

[0295] In some examples, such as when the balloon 638 is attached at both ends thereof to the dilator 622 and balloon catheter 632, both the dilator 622 with dilator shaft 640 and the balloon catheter 632 can optionally 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 632 can cause the dilator shaft 640 to move therewith, or axial movement of one of the dilator shaft 640 or dilator 622 can cause the balloon catheter 632 to move therewith.

[0296] The dilator shaft 640 can optionally extend through the balloon catheter lumen 634, and may be sized such that an annular space is formed within balloon catheter lumen 634 between an inner surface of the balloon catheter 632 and an outer surface of the dilator shaft 640 along the length of balloon catheter 632. This annular space is in fluid communication with one or more inflation openings 636 exposed to an internal cavity of the balloon 638, which can optionally be in fluid communication, via adaptor port 644b of balloon catheter adaptor 642, with a fluid source (for example, a syringe or a pump) that can optionally inject inflation fluid (for example, saline) into the balloon 638, so as to inflate the balloon 638, for example during formation of a leaflet opening 52 as will be described in greater detail below and shown, for example, in Fig. 29D. The pressure of the inflation fluid within balloon 638 may provide the force that allows it to dilate a leaflet opening 52. Further, the balloon catheter lumen 634 may be configured to withdraw fluid from the balloon 638 through the inflation opening(s) 636, to deflate the balloon 638.

[0297] In some cases, a steerable outer catheter 610 of the steerable delivery apparatus 602 can optionally be steered towards the site of treatment so as to generally face the host valvular structure 12. Optionally, the smaller-sized delivery catheter 208 can be then extended out of the outer catheter 610, 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 632 into the delivery catheter 208, as shown in Fig. 28, can facilitate easier navigation thereof towards the specific host leaflet 10 and its pilot puncture 50.

[0298] While a dilation apparatus 620 is shown in Fig. 28 to extend through the delivery catheter 208 while the guidewire 80 can remain in position after retraction of the anchor device 237 and needle 218 during removal of the second handle portion 206, it is to be understood that this configuration is shown by way of illustration and not limitation. In some examples, the guidewire 80 can optionally be retrieved from the patient's body while the outer catheter 610 and delivery catheter 208 remain in position, prior to insertion of the balloon catheter 632. Optionally, the same guidewire 80 or a different guidewire can be then optionally reinserted, for example through the first adapter portion 644a of the balloon catheter adaptor 642, over which the balloon catheter 632 can be guided towards the pilot puncture 50 of the host leaflet 10, through delivery catheter lumen 210.

[0299] Figs. 29A-29E illustrate some steps in an exemplary method for utilizing a dilation apparatus 620 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 237 and needle 218, the balloon 638, carried over the balloon catheter632, can optionally be advanced towards the host leaflet 10 according to any of the methods described above.

[0300] In some examples, when the dilation apparatus 620 further includes a dilator 622 as also shown in the example illustrated in Fig. 29A, the dilator 622 can be advanced, optionally along with the balloon catheter 632 and balloon 638, towards the host leaflet 10. When included in dilation apparatus 620, the dilator 622 can optionally be inserted into the pilot puncture 50 to expand the pilot puncture 50, as shown in Fig. 29B. As the dilator 622 is inserted into the host leaflet 10, the inherent resiliency of the leaflet 10 may urge the leaflet 10 radially inwardly against the dilator 622. The dilator 622 can optionally have sufficient stiffness to facilitate advancement thereof through the leaflet 10, wherein the gradually tapering shape of the dilator 622 facilitates expanding the pilot puncture 50 to a greater diameter.

[0301] In a subsequent step of the method, illustrated in Fig. 29C, the balloon 638 may be inserted within the pilot puncture 50, such as by further advancement of the dilator 622 with dilator shaft 640 and / or balloon catheter 632. With the balloon 638 received within the pilot puncture 50, inflating the balloon 638 to transition it from a radially deflated state (Fig. 29C) to a radially inflated state (Fig. 29D) 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 balloon 638 is inflated to form the leaflet opening 52 as shown in Fig. 29D, the balloon 638 is deflated, as shown in Fig. 29E, optionally allowing for insertion of a guest prosthetic valve inside the leaflet opening 52.

[0302] In some examples, inflating the balloon 638 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.

[0303] In some examples, inflating the balloon 638 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).

[0304] While a dilation apparatus 620 that includes a balloon 638 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 optionally be used as an expansion member instead of a balloon.

[0305] In some examples, retraction of the balloon 638, after deflation thereof, can optionally be performed while the guidewire 80 may be kept in position, extending through the leaflet opening 52. Subsequent to deflation of the balloon 638 (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 optionally further include a step of positioning a guest prosthetic valve 100 inside the leaflet opening 52. A replacement valve delivery apparatus 670 carrying the guest prosthetic valve 100 can optionally be either part of the system 600, or provided as a separate assembly of apparatus 670 advanced into a leaflet opening 52.

[0306] Fig. 29F shows a guest prosthetic valve 100 positioned, in a radially compressed configuration thereof, inside the leaflet opening 52. Optionally, as shown in Fig. 29F, the guest prosthetic valve 100 can be mounted on a replacement valve delivery apparatus 670 that can be advanced towards the host leaflet 10 over a guide wire, which can be a separate guide wire (not shown), or can be the same guidewire 80.

[0307] In some examples, the guest prosthetic valve is a balloon expandable valve, and the replacement valve delivery apparatus 670 comprises a balloon catheter 672 carrying a balloon 674, which can be also referred to as a second balloon 674 or a valve-expanding balloon 674. In contrast to some optional examples of a balloon 638 described above, which can be also referred to as a hole-dilating balloon 638 or a first balloon 638 configured to form a leaflet opening 52 without tearing the host leaflet, the maximum diameter to which the second balloon 674 can be inflated can optionally 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. Throughout the specification and the claims, the balloon catheter 632 can be also referred to as a first balloon catheter, the balloon 638 can be also referred to as a first balloon, the balloon catheter 672 can be also referred to as a second balloon catheter, and the balloon 674 can be also referred to as a second balloon.

[0308] While a replacement valve delivery apparatus 670 equipped with a balloon 674 at a distal end portion of a balloon catheter 672 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 670can optionally 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.

[0309] In some examples, the replacement valve delivery apparatus 670 can optionally further include a nosecone 676 positioned distal to the balloon 674 (or other prosthetic-valve expanding mechanism). The nosecone 676 can optionally be conical or frustoconical in shape. Optionally, the nosecone 676 can be attached to a distal end of a nosecone shaft 678 extending through the balloon catheter 672, wherein the nosecone 676 and the nosecone shaft 678 can collectively define a lumen through which a guidewire can extend. In some examples, when a nosecone 676 is present at a distal end of the replacement valve delivery apparatus 670 as also shown in the example illustrated in Fig. 29F, the nosecone 676 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 676 is inserted into the leaflet opening 52 it can optionally further expand the leaflet opening 52 to a greater diameter.

[0310] As shown in Fig. 29F, the guest prosthetic valve 100 is placed in the leaflet opening 52 in its radially compressed configuration, optionally positioned over a deflated balloon 674 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. 29G, 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.

[0311] In some examples, the guest prosthetic valve can optionally 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 optionally be a selfexpandable prosthetic valve that can optionally be retained during delivery toward the host valvular structure in a capsule or other restraint disposed therearound, and valve expansion canbe 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.

[0312] Figs. 30A-31B illustrate a sequence of events in which a host valvular structure 12 is modified to receive a guest prosthetic valve 100. Figs. 30A-30B illustrate the balloon 638 utilized to expand the pilot puncture 50 into the leaflet opening 52. In particular, Fig. 30A illustrates the balloon 638 in a deflated state within the pilot puncture 50, corresponding to the state described above with respect to Fig. 29C, while Fig. 30B illustrates the balloon 638 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. 29D. Fig. 30C illustrates a guest prosthetic valve 100 that can be positioned in the leaflet opening 52 after removal of the balloon 638 therefrom, in a crimped configuration of the prosthetic valve 100, corresponding to the state described above with respect to Fig. 29F, after which the guest prosthetic valve 100 can be expanded, such as by inflating a balloon 674 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.

[0313] As mentioned, any system, apparatus and method of the current specification can optionally 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. 31 A shows a previously implanted prosthetic valve 100a subsequent to forming the leaflet opening 52. Fig. 3 IB 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. 3 IB, 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.

[0314] In the example of Fig. 31 A, 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.

[0315] As shown in Fig. 3 IB, 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 openings112b 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 114a. In some examples, expanding the frame 102b within the leaflet 114a 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.

[0316] While a tissue perforation apparatus 200 is described herein as part of a stabilized tissue modification system 600 that includes a steerable delivery apparatus 602 equipped with an outer catheter 610 through which a distal portion of the tissue perforation apparatus 200 can be advanced, it is to be understood that any exemplary tissue perforation apparatus 200 disclosed herein can optionally be used in isolation, and without a separate steerable delivery apparatus 602.

[0317] While a tissue perforation apparatus 200 is described herein as part of a stabilized tissue modification system 600 that includes a dilation apparatus 620 that includes an expansion member, such as a balloon 638, used to form a tissue opening (e.g., leaflet opening 52) after retraction of the anchor device 237 and needle 218 from a pilot puncture 50 formed thereby, it is to be understood that any exemplary tissue perforation apparatus 200 disclosed herein can optionally be used in isolation, and without a separate dilation apparatus 620. In some examples, any exemplary tissue perforation apparatus 200 disclosed herein can optionally further include an expansion member, such as a balloon 638 mounted on a balloon catheter 632, as part of the tissue perforation apparatus 200 itself.

[0318] 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 optionally 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 balloon 638, to further expand the opening, and may not involve procedural steps of guest prosthetic valve implantation.

[0319] As mentioned above, the valve assembly 370 is configured to seal against any catheter or shaft passable therethrough, including components of a dilation apparatus 620 such as dilator 622, balloon 638, and / or balloon catheter 632. In some instances, a compressive force applied by the valves of the valve assembly against components of the dilation apparatus 620 during advancement therethrough may make it harder to insert the dilation apparatus 620 into andthrough the valve assembly. For example, a dilator 622 of a dilation apparatus 620 can be a relatively soft elongated component, optionally having a relatively small durometer, which can pose a challenge when attempting to forcibly insert it through the valve assembly 370 of the first handle portion 204.

[0320] In some examples, a tear-away sleeve 650 is fitted around a distal portion of the dilation apparatus 620, configured to facilitate insertion of the dilation apparatus 620 into and through the valve assembly 370. Fig. 32 shows a perspective view of an exemplary tear-away sleeve 650. The tear-away sleeve 650 comprises a sleeve body 652 extending from a proximal portion 658 to a distal end 654, wherein the sleeve body 652 comprises at least one weakened line 656 configured to tear and allow the sleeve body 652 to be peeled away and removed from the dilation apparatus 620.

[0321] A tear-away sleeve 650cillustrated in Fig. 32 is an exemplary implementation of tearaway sleeve 650, and thus can include any of the features described for tear-away sleeve 650 throughout the current disclosure, except that the tear-away sleeve 650cfurther comprises tabs 660 attached to the proximal portion 658. In some examples, the proximal portion 658cof exemplary tear-away sleeve 650ccan be conical or frustoconical, flaring radially outwards in the proximal direction from the sleeve body 652.

[0322] In some examples, the at least one weakened line 656 extends along the length of the sleeve body 652, between the distal end 654 and the proximal portion 658. In some examples, one or more weakened lines 656 can continuously extend from the sleeve body 652 towards, and along at least a part of, the proximal portion 658. In some examples, the sleeve body 652 and the proximal portion 658 are integrally formed, defining together a unitary component.

[0323] In some examples, the at least one weakened line 656 comprises two axial weakened lines 656 that can be optionally diametrically opposed to each other, as shown, for example, in Fig. 32. Two axially-extending weakened lines 656 can divide the sleeve body 652 into two elongated halves, wherein, in the case of exemplary tear-away sleeve 650c, each tab can be circumferentially aligned with one of these halves.

[0324] Fig. 33 is a side view of the tear-away sleeve 650cof Fig. 32 fitted over a distal portion of the dilation apparatus 620, wherein the sleeve body is shown with partial transparency to show components of the dilation apparatus 620 disposed therein. In some examples, the tearaway sleeve 650 is disposed over the dilation apparatus 620 such that the sleeve body 652 covers at least the dilator 622 and the balloon 638, optionally further extending along a portion of the balloon catheter 632 such that the proximal portion 658 of the tear-away sleeve 650 isproximal to the balloon 638. In some examples, the distal end 654 of the sleeve body 652 is axially aligned with, or is distal to, the dilator distal end 624.

[0325] Fig. 34 shows the dilation apparatus 620 with the tear-away sleeve 650 prior to insertion into and through the first handle portion 204. After separation of the second handle portion 206 from the first handle portion 204 as described above, the dilation apparatus 620 is advanced over the guidewire 80 extending through the first handle portion 204. A distal portion of the dilation apparatus 620 is covered by the tear-away sleeve 650 in a manner similar to that described above and shown in Fig. 33.

[0326] Fig. 35 is a cross-sectional view showing the dilation apparatus 620 with the tear-away sleeve 650 extending through the first handle portion 204, such that the dilator 622, and optionally the balloon 638 as well, are axially positioned distal to the valve assembly 370. In some examples, the length of the sleeve body 652 is such that when the dilator 622 and the balloon 638 are positioned distal to the valve assembly 370, the proximal portion 658 of the tear-away sleeve 650 is positioned proximal to the first handle portion 204, allowing the proximal portion 658 to be grasped to initiate tearing along the one or more weakened lines 656.

[0327] In some examples, when the dilator 622 and the balloon 638 are positioned distal to the valve assembly 370, the sleeve body 652 extends along at least part of the delivery catheter 208 extending distally from the first handle portion 204. While the dilator 622 and the sleeve body 652 disposed thereover can optionally extend further towards, through, and even past the handle 604 of the steerable delivery apparatus 602, in some examples, the dilator 622 and / or sleeve body 652 can terminate proximal to the handle 604 of the steerable delivery apparatus 602. For example, the distal end 654 of the sleeve body 652 is shown in Fig. 35 to be proximal to the handle 604. While the handle 604 of the steerable delivery apparatus 602 can also optionally include a valve assembly, similar to valve assembly 360 of the first handle portion 204, a valve assembly of the handle 604 does not pose the same risk with respect to the dilation apparatus 620, since the dilation apparatus 620 extends into and through the delivery catheter 208, preventing the dilator 622 or balloon 638 from being directly contacted by an optional valve assembly of the steerable delivery apparatus 602.

[0328] In some examples, the sleeve body 652 is tightly mounted around the distal portion of the dilation apparatus 620 in a manner that can advantageously further assist in maintaining the balloon in a compacted configuration therein, and protect both the relatively flexible and delicate dilator 622 and the compacted balloon 638 during handling of the dilation apparatus620 by a user, such as in the stages of preparation and insertion into the first handle portion 204.

[0329] After the dilator 622 and the balloon 638 are positioned distal to the valve assembly 370, as shown for example in Fig. 35, the tabs 660 of an exemplary tear-away sleeve 650ccan be outwardly pulled away from each other, such that the sleeve body 652 can be split along the weakened line 656, thus allowing the split portions to be proximally pulled and removed from around the deliver}' apparatus.

[0330] In some examples, the at least one weakened line 656 comprises a thinned line. Tn some examples, the at least one weakened line 656 comprises a perforated parting line.

[0331] In some examples, such as when the weakened lines 656 continuously extend along the proximal portion 658 as well, pulling both sides of the proximal portion outwardly away from each other, such as by outwardly pulling the tabs 660, serves to split the proximal portion 658 along with the sleeve body 652. In some examples, the proximal portion 658 can be optionally already split to two halves, such as by including diametrically opposing slits instead of continuous weakened lines.

[0332] Fig. 36 is a perspective view of an exemplary tear-away sleeve 650d, which can be similar to any example described above with respect to tear-away sleeve 650c, except that the tear-away sleeve 650dis devoid of tabs 660. In some examples, the proximal portion 658dof tear-away sleeve 650dis substantially cylindrical, having a uniform diameter similar to the diameter of the sleeve body 652. In some examples, the proximal portion 658dcomprises two slits 662 that can be diametrically opposite to each other, defining two halves of the proximal portion 658d. As shown in Fig. 36, the slits 662 are circumferentially aligned with the weakened lines 656 and / or continuous therewith. In some examples, the weakened lines 656 can continuously extend from the sleeve body 652 towards and along the proximal portion 658, optionally instead of slits 662, in a manner that can be somewhat similar to that illustrated in Fig. 32 for exemplary proximal portion 658c.

[0333] Fig. 37 shows initiation of splitting or tearing the tear-away sleeve 650dof Fig. 36, illustrated in Fig. 37 without components of the tissue perforation apparatus 200 or the steerable delivery apparatus 602 for ease of illustration. As shown, the two opposite sides of the proximal portion 658dcan be outwardly pulled to facilitate tearing along the weakened lines 656.

[0334] In some examples, weakened lines 656 in the form of thinned lines can be formed as elongated recesses during formation of the sleeve body 652, such as by extrusion. In some examples, weakened lines 656 in the form of thinned lines can be formed as elongated recesses or cuts which can be cut into the thickness of the sleeve body 652 (without passing through theentire wall thickness) after formation of the sleeve body (e.g., after extrusion). In contrast to conventional peel-away sleeves, a sleeve body 652 formed for used with a dilation apparatus 620 of a balloon 638 disclosed herein may have a relatively small wall thickness to begin with, making it harder to form even thinner weakened lines 656 during extrusion or by cutting thereafter. In some examples, thinned weakened lines 656 are formed along the sleeve body 652 by laser etching.

[0335] Fig. 38 demonstrates another exemplary method by which weakened lines 656 can be formed at diametrically opposite side of the sleeve body 652, for example by temporarily flattening the sleeve body 652, such as by a roller 666 shown in Fig. 38 or other compressing apparatus, such that the folds formed on both sides of the flattened sleeve body 652 created the weakened lines 656.

[0336] Figs. 39A and 39B are side views of a portion of a sleeve body 652 of an exemplary tear-away sleeve 650e, shown in untorn and tom configurations thereof, respectively. Tearaway sleeve 650eis an exemplary implementation of tear-away sleeve 650, and thus can include any of the features described for tear-away sleeve 650 throughout the current disclosure, except that the tear-away sleeve 650ecomprises weakened line 656 extending helically along the sleeve body 652, as shown in Fig. 39A.

[0337] In contrast to the diametrically opposing axial weakened lines 656 described above, when a helical weakened line 656 is torn, it does not split the sleeve body 652 into two halves, but rather forms a helically spiraling strip, as shown in Fig. 39B, which can be then peeled away from the dilation apparatus. While a single helically-extending weakened line 656 is shown in Figs. 39A-B, it is to be understood that in some examples, a plurality of weakened lines 656 can helically extend along the sleeve body 652, optionally in parallel to each other.

[0338] Any of the systems, devices, apparatus, etc. disclosed herein can optionally 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 optionally 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

[0339] 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 takenin 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.

[0340] Example 1. A tissue perforation apparatus comprising: a handle comprising a first handle portion and a second handle portion releasably coupled to the first handle portion; a delivery catheter rigidly attached, at a delivery catheter proximal end portion thereof, to the first handle portion; an anchor device comprising: an anchor shaft coupled to the second handle portion and configured to rotate upon actuation of an anchor control knob of the second handle portion; and a helical anchor head distal to the anchor shaft; a needle comprising: a needle shaft coupled to the second handle portion and configured to be axially moved relative to the anchor shaft upon actuation of a needle advancement knob of the second handle portion; a needle head at a distal end of the needle shaft; and wherein the needle shaft extends through the anchor shaft; and wherein the anchor shaft extends through the delivery catheter when the second handle portion is coupled to the first handle portion.

[0341] Example 2. The apparatus of any example herein, particularly example 1, wherein the second handle portion and the first handle portion are axially movable relative to each other.

[0342] Example 3. The apparatus of any example herein, particularly example 1 or 2, wherein the second handle portion comprises an extension body comprising: a distal section extending between an inner surface of a distal housing of the first handle portion and an outer surface of a distal support body of the first handle portion, when the second handle portion is coupled to the first handle portion, an intermediate section axially aligned with the anchor control knob; a proximal section extending into a proximal housing of the second handle portion; and an extension body bore extending through the distal section, the intermediate section, and the proximal section.

[0343] Example 4. The apparatus of any example herein, particularly example 3, wherein the second handle portion further comprises a connector body disposed inside the intermediate section of the extension body, and wherein the anchor device is coupled to the connector body.

[0344] Example 5. The apparatus of any example herein, particularly example 4, wherein the connector body is rotatable relative to the intermediate section of the extension body.

[0345] Example 6. The apparatus of any example herein, particularly example 5, wherein the anchor device is coupled to the connector body such that rotation of the connector body rotates the anchor shaft therewith.

[0346] Example 7. The apparatus of any example herein, particularly example 6, wherein the anchor device extends into a distal bore portion of the connector body.

[0347] Example 8. The apparatus of any example herein, particularly example 7, wherein the anchor device comprises a non-circular flange affixed to the anchor shaft, wherein the noncircular flange resides in the distal bore portion of the connector bore, and wherein the distal bore portion of the connector bore has a non-circular profile matching a non-circular profile of the non-circular flange.

[0348] Example 9. The apparatus of any example herein, particularly example 8, wherein the non-circular flange comprises at least one flat.

[0349] Example 10. The apparatus of any example herein, particularly example 7, wherein the anchor device comprises a reinforcement tube disposed around a proximal end portion of the anchor shaft and affixed thereto.

[0350] Example 11. The apparatus of any example herein, particularly example 10, wherein the reinforcement tube comprises a proximal tube end portion extending into the distal bore portion of the connector bore.

[0351] Example 12. The apparatus of any example herein, particularly example 11, wherein the proximal tube end portion comprises at least one tube recess, and wherein the connector body comprises at least one radial protrusion extending into the at least one tube recess.

[0352] Example 13. The apparatus of any example herein, particularly any one of examples 7 to 12, wherein the connector body further comprises a proximal bore portion continuous with the distal bore portion and smaller in size than the distal bore portion.

[0353] Example 14. The apparatus of any example herein, particularly example 13, wherein the anchor device terminates in the distal bore portion, and wherein the needle shaft extends proximally from the anchor shaft into and through the proximal bore portion.

[0354] Example 15. The apparatus of any example herein, particularly any one of examples 5 to 14, wherein the connector body comprises connector outer gear teeth.

[0355] Example 16. The apparatus of any example herein, particularly example 15, wherein the anchor control knob comprises inner gear teeth.

[0356] Example 17. The apparatus of any example herein, particularly example 16, wherein the inner gear teeth of the anchor control knob are axially aligned with the connector outer gear teeth.

[0357] Examplel8. The apparatus of any example herein, particularly example 16 or 17, wherein rotation of the anchor control knob is configured to rotate the connector body.

[0358] Example 19. The apparatus of any example herein, particularly any one of examples 16 to 18, wherein the second handle portion further comprises one or more idler gears disposed between the anchor control knob and the connector body.

[0359] Example 20. The apparatus of any example herein, particularly example 19, wherein outer gear teeth of each of the one or more idler gears are meshed with the inner gear teeth of the anchor control knob and with the connector outer gear teeth.

[0360] Example 21. The apparatus of any example herein, particularly example 19 or 20, wherein the one or more idler gears reside inside one or more radial bores of the intermediate section of the extension body.

[0361] Example 22. The apparatus of any example herein, particularly any one of examples 19 to 21 , wherein each of the one or more idler gears defines a central bore through which a corresponding support shaft of the second handle portion extends.

[0362] Example 23. The apparatus of any example herein, particularly example 22, wherein each support shaft distally extends from a plate positioned proximal to the intermediate section of the extension body.

[0363] Example 24. The apparatus of any example herein, particularly any one of examples 3 to 23, wherein the anchor control knob further comprises a plurality of notches defined along an inner surface of the anchor control knob, and wherein the second handle portion further comprises one or more biased detent elements which are radially biased towards the notches.

[0364] Example 25. The apparatus of any example herein, particularly example 24, wherein each of the one or more biased detent elements is biased radially outwards by a detent spring.

[0365] Example 26. The apparatus of any example herein, particularly example 25, wherein each detent spring resides inside a socket of the intermediate section of the extension body.

[0366] Example 27. The apparatus of any example herein, particularly any one of examples 24 to 26, wherein the one or more biased detent elements are configured to produce a clicking sound during rotation of the anchor control knob.

[0367] Example 28. The apparatus of any example herein, particularly any one of examples 3 to 28, wherein the needle advancement knob comprises a lead member defining a lead bore, and wherein the needle shaft is rigidly attached to a carriage of the second handle portion, wherein the carriage resides inside the lead bore and is axially movable within the lead bore.

[0368] Example 29. The apparatus of any example herein, particularly example 28, wherein the proximal section of the extension body comprises an axial guide extension extending through the lead bore and defining one or more guide slots.

[0369] Example30. The apparatus of any example herein, particularly example 29, wherein the carriage comprises a carriage head having one or more head radial projections extending radially through the one or more guide slots.

[0370] Example 31. The apparatus of any example herein, particularly example 30, wherein the lead member of the needle advancement knob comprises a lead internal thread, and wherein each of the one or more head radial projections comprises a carriage outer thread that engages the lead internal thread.

[0371] Example 32. The apparatus of any example herein, particularly example 31, wherein rotation of the needle advancement knob is configured to cause axial movement of the carriage.

[0372] Example 33. The apparatus of any example herein, particularly any one of examples 29 to 32, wherein the carriage further comprises a rear port extending proximally from the carriage head.

[0373] Example 34. The apparatus of any example herein, particularly example 33, wherein the carriage defines a carriage bore extending therethrough.

[0374] Example 35. The apparatus of any example herein, particularly example 33 or 34, wherein a proximal wall portion of the proximal housing comprises a rear opening sized to enable extension of the rear port therethrough.

[0375] Example 36. The apparatus of any example herein, particularly any one of examples 28 to 35, wherein the second handle portion further comprises a safety knob movable between a locking position and an unlocking position, wherein the safety knob is configured to prevent rotational movement of the needle advancement knob in the locking position, and allow rotational movement of the needle advancement knob in the unlocking position.

[0376] Example 37. The apparatus of any example herein, particularly example 36, wherein the safety knob is axially movable relative to the lead member.

[0377] Example 38. The apparatus of any example herein, particularly example 37, wherein the safety knob is slidable along a guide slot formed in the proximal housing.

[0378] Example 39. The apparatus of any example herein, particularly example 37 or 38, wherein the safety knob comprises a stopper configured to limit axial movement of the safety knob, wherein the stopper is configured to move within a wall recess of the proximal housing.

[0379] Example 40. The apparatus of any example herein, particularly any one of examples 36 to 39, wherein the safety knob comprises a radial protrusion configured to reside inside a recess of the lead member in the locking position, and be move out of the recess of the lead member in the unlocking position.

[0380] Example 41. The apparatus of any example herein, particularly any one of examples 36 to 40, wherein the safety knob is biased to the locking position.

[0381] Example 42. The apparatus of any example herein, particularly example 41, wherein the safety knob comprises a knob magnet configured to be magnetically attracted to a fixed magnet attached to the proximal housing.

[0382] Example 43. The apparatus of any example herein, particularly any one of examples 3 to 42, wherein the first handle portion further comprises a valve assembly positioned inside the distal support body.

[0383] Example 44. The apparatus of any example herein, particularly example 43, wherein the valve assembly comprises a cross-slit valve, a disc valve distal to the cross-slit valve, and a hemostatic valve distal to the disc valve.

[0384] Example 45. The apparatus of any example herein, particularly example 44, wherein the cross-slit valve comprises a semi-spherical portion and define an aperture.

[0385] Example 46. The apparatus of any example herein, particularly example 45, wherein the disc valve comprises a circulatory body portion and an aperture aligned with the aperture of the cross-slit valve.

[0386] Example 47. The apparatus of any example herein, particularly example 46, wherein the hemostatic valve comprises a pair of flaps defining elongated slits therebetween.

[0387] Example 48. The apparatus of any example herein, particularly any one of examples 45 to 47, wherein the first handle portion further comprises a rigid retainer positioned inside the distal support body and proximal to the valve assembly, and wherein the rigid retainer comprises a central opening aligned with the aperture of the cross-slit valve.

[0388] Example 49. The apparatus of any example herein, particularly any one of examples 43 to 49, wherein the delivery catheter proximal end portion is distal to the valve assembly.

[0389] Example 50. The apparatus of any example herein, particularly any one of examples 3 to 49, wherein the distal support body further comprises one or more axial alignment projections, and wherein the distal section of the extension body further comprises one or more axial alignment recesses configured to slide along the one or more axial alignment projections.

[0390] Example 51. The apparatus of any example herein, particularly any one of examples 3 to 50, wherein the first handle portion further comprises an engagement knob configured to control engagement of the first handle portion with the second handle portion.

[0391] Example 52. The apparatus of any example herein, particularly example 51, wherein the engagement knob is rotatable relative to the distal housing.

[0392] Example 53. The apparatus of any example herein, particularly example 52, wherein the first handle portion further comprises a plurality of locking balls, each locking ball residingin a radial hole extending from an outer surface of the distal housing to the inner surface of the distal housing.

[0393] Example 54. The apparatus of any example herein, particularly example 53, wherein the each of the plurality of locking balls is biased radially outwards in a free state thereof.

[0394] Example 55. The apparatus of any example herein, particularly example 54, wherein each radial hole comprises a cylindrical portion and an inner phase that tapers from the cylindrical portion towards the inner surface of the distal housing.

[0395] Example 56. The apparatus of any example herein, particularly any one of examples 53 to 55, wherein the plurality of locking balls are circumferentially spaced from each other, and are axially aligned with each other.

[0396] Example 57. The apparatus of any example herein, particularly any one of examples 53 to 56, wherein the distal section of the extension body comprises a plurality of notches configured to accept the plurality of locking balls therein.

[0397] Example 58. The apparatus of any example herein, particularly example 57, wherein the plurality of notches comprises a plurality of notch groups axially spaced from each other.

[0398] Example 59. The apparatus of any example herein, particularly any one of examples 53 to 58, wherein the engagement knob is configured to move the handle between a connected configuration, by radially pressing the locking balls against the distal section of the extension body in a manner that prevents movement between the second handle portion and the first handle portion, and a released configuration, by allowing the locking balls to be radially spaced from the distal section of the extension body.

[0399] Example 60. The apparatus of any example herein, particularly example 59, wherein the engagement knob comprises a plurality of tapered recessed portions along an inner surface thereof, each of the tapered recessed portions extends from a narrow region to a wide region, wherein, when the locking balls are aligned with the narrow regions and are pressed thereby radially inwards, the handle is in the connected configuration, and when the locking balls are aligned with the wide regions, the handle is in the release configuration.

[0400] Example 61. The apparatus of any example herein, particularly example 60, wherein the engagement knob comprises a plurality of radial protrusions which are circumferentially movable between adjacent radial projections of the distal housing.

[0401] Example 62. The apparatus of any example herein, particularly example 61, wherein the plurality of radial protrusions is axially offset from the plurality of tapered recess portions.

[0402] Example 63. The apparatus of any example herein, particularly any one of examples 52 to 62, wherein the engagement knob further comprises at least one pin bore laterally extendingtherethrough and partially exposed to an annular recess of the distal housing, and wherein the engagement knob is rotatably coupled to the distal housing by at least one pin extending through the at least one pin bore.

[0403] Example 64. The apparatus of any example herein, particularly example 52, wherein the engagement knob further comprises a knob internal thread, and wherein the distal section of the extension body comprises a body outer thread configured to threadedly engage with the knob internal thread.

[0404] Example 65. The apparatus of any example herein, particularly example 64, wherein, when the body outer thread is threadedly engaged with the knob internal thread, rotation of the engagement knob facilitates axial movement of the second handle portion relative to the first handle portion.

[0405] Example 66. The apparatus of any example herein, particularly example 64 or 65, wherein the engagement knob comprises a lead body, and wherein the knob internal thread is defined by the lead body of the engagement knob.

[0406] Example 67. The apparatus of any example herein, particularly any one of examples 64 to 66, wherein the second handle portion further comprises a safety latch coupled to the distal section of the extension body, the safety latch comprising a proximal latch portion, a distal latch portion, and a tooth extending radially from the distal latch portion.

[0407] Example 68. The apparatus of any example herein, particularly example 67, wherein the safety latch is pivotably connected to the distal section of the extension body by a hinge attached to the distal latch portion.

[0408] Example 69. The apparatus of any example herein, particularly example 68, further comprising a latch spring extending between the distal latch portion and the distal section of the extension body, the latch spring configured to bias the safety latch to a locked state thereof.

[0409] Example 70. The apparatus of any example herein, particularly example 69, wherein the tooth is configured to reside inside a recess of the distal support body when the safety latch is in the locked state.

[0410] Example 71. The apparatus of any example herein, particularly example 70, wherein, when the tooth resides inside the recess of the distal support body and the safety latch is in the locked state, a radial step defined by the recess of the distal support body prevents retraction of the second handle portion from the first handle portion.

[0411] Example 72. The apparatus of any example herein, particularly example 70 or 71, wherein, when the proximal latch portion is depressed, the safety latch is moved to an unlocked state thereof by pivotably moving the tooth radially out of the recess of the distal support body.

[0412] Example 73. The apparatus of any example herein, particularly any one of examples 1 to 72, wherein the anchor shaft is a flexible torque shaft configured transmit rotational movement thereof, when rotated by the anchor control knob, to the helical anchor head.

[0413] Example 74. The apparatus of any example herein, particularly example 73, wherein the anchor shaft comprises a helical hollow strand tube.

[0414] Example 75. The apparatus of any example herein, particularly any one of examples 1 to 74, wherein the helical anchor head comprises a plurality of helical turns and terminates with an anchor tip.

[0415] Example 76. The apparatus of any example herein, particularly any one of examples 1 to 75, wherein the needle head defines an angled surface terminating at a needle tip.

[0416] Example 77. The apparatus of any example herein, particularly any one of examples 1 to 76, wherein the needle shaft comprises a needle shaft distal portion comprising a plurality of circumferential slits.

[0417] Example 78. The apparatus of any example herein, particularly example 77, wherein the needle shaft further comprises a proximal portion extending proximally from the distal portion of the needle shaft.

[0418] Example 79. The apparatus of any example herein, particularly example 78, wherein the proximal portion of the needle shaft is devoid of circumferential slits.

[0419] Example 80. The apparatus of any example herein, particularly example 79, wherein the proximal portion of the needle shaft comprises a polymeric material.

[0420] Example 81. A method comprising: advancing a distal portion of a tissue perforation apparatus, over a guidewire, inside a patient's body to a target tissue, wherein the tissue perforation apparatus comprises a handle having a first handle portion and a second handle portion releasably attached to the first handle portion, a delivery catheter attached to the first handle portion, an anchor device having an anchor shaft coupled to the second handle portion and extending through the delivery catheter, and a needle coupled to the second handle portion and extending through the anchor shaft; anchoring a helical anchor head of the anchor device to a target tissue, by rotating an anchor control knob of the second handle portion in a first rotational direction of the anchor control knob, thereby causing the anchor shaft and the helical anchor head to rotate therewith; and forming a pilot puncture in the target tissue by rotating a needle advancement knob of the second handle portion in a first rotational direction of the needle advancement knob, which causes distal axial movement of the needle relative to the anchor device.

[0421] Example 82. The method of any example herein, particularly example 81, wherein the needle comprises a needle head and a needle shaft extending proximally from the needle head and into the handle.

[0422] Example 83. The method of any example herein, particularly example 82, wherein the needle head terminates at a needle tip, and wherein the forming the pilot puncture comprises penetrating through the target tissue with the needle head.

[0423] Example 84. The method of any example herein, particularly example 83, wherein the helical anchor terminates at an anchor tip.

[0424] Example 85. The method of any example herein, particularly example 84, wherein the advancing the distal portion of the tissue perforation apparatus comprises maintaining the needle tip proximal to the anchor tip.

[0425] Example 86. The method of any example herein, particularly example 84 or 85, wherein the advancing the distal portion of the tissue perforation apparatus comprises maintaining the anchor tip proximal to a distal end of the delivery catheter.

[0426] Example 87. The method of any example herein, particularly any one of examples 82 to 86, wherein the needle shaft is rigidly attached to a carriage of the second handle portion, and wherein the rotating the needle advancement knob comprises rotating a lead member of the needle advancement knob, thereby causing axial movement of the carriage which is threadedly engaged with the lead member.

[0427] Example 88. The method of any example herein, particularly example 87, wherein the axial movement of the carriage is along an axial guide extension residing inside a lead bore of the lead member.

[0428] Example 89. The method of any example herein, particularly example 87 or 88, wherein the rotating the needle advancement knob further comprises moving a safety knob of the second handle portion from a locking position to an unlocking position thereof.

[0429] Example 90. The method of any example herein, particularly example 89, wherein the moving the safety knob to the unlocking position comprises moving a radial protrusion of the safety knob out of a recess formed in a proximal end portion of the lead member.

[0430] Example 91. The method of any example herein, particularly example 89 or 90, wherein the moving the safety knob to the unlocking position comprises proximally sliding the safety knob along a guide slot of a proximal housing disposed around the lead member.

[0431] Example 92. The method of any example herein, particularly example 91, wherein the moving the safety knob to the unlocking position comprises distancing a knob magnet of the safety knob from a fixed magnet attached to the proximal housing.

[0432] Example 93. The method of any example herein, particularly any one of examples 81 to 92, wherein the rotating the anchor control knob comprises causing a connector body to which the anchor shaft is attached, to rotate therewith.

[0433] Example 94. The method of any example herein, particularly example 93, wherein the rotating the anchor control knob comprises rotating one or more idler gears which are meshed with inner gear teeth of the anchor control knob and with connector outer gear teeth of the connector body.

[0434] Example 95. The method of any example herein, particularly any one of examples 81 to 94, further comprising, prior to the advancing the tissue perforation apparatus, advancing an outer catheter of a steerable delivery apparatus to the target tissue.

[0435] Example 96. The method of any example herein, particularly example 95, wherein the advancing the tissue perforation apparatus comprises advancing the tissue perforation apparatus through the outer catheter.

[0436] Example 97. The method of any example herein, particularly any one of examples 81 to 96, further comprising, after the forming the pilot puncture, retracting the needle from the pilot puncture.

[0437] Example 98. The method of any example herein, particularly example 97, wherein the retracting the needle from the pilot puncture comprises rotating the needle advancement knob in a direction opposite to the first rotational direction of the needle advancement knob.

[0438] Example 99. The method of any example herein, particularly any one of examples 81 to 98, further comprising, releasing the helical anchor head from the target tissue.

[0439] Example 100. The method of any example herein, particularly example 99, wherein the releasing the helical anchor head comprises rotating the anchor control knob in a direction opposite to the first rotational direction of the anchor control knob.

[0440] Example 101. The method of any example herein, particularly example 99 or 100, further comprising, after the releasing the helical anchor head, retrieving the anchor device and the needle from the patient's body, while maintaining the delivery catheter in position.

[0441] Example 102. The method of any example herein, particularly example 101, wherein the retrieving the anchor device and the needle comprises releasing the second handle portion from the first handle portion and proximally pulling the second handle portion away from the first handle portion.

[0442] Example 103. The method of any example herein, particularly example 102, wherein the releasing the second handle portion from the first handle portion comprises rotating an engagement knob of the first handle portion to allow locking balls of the first handle portion tospring radially away from notches of a distal section of an extension body of the second handle portion.

[0443] Example 104. The method of any example herein, particularly example 102, wherein the releasing the second handle portion from the first handle portion comprises depressing a proximal latch portion of a safety latch of the second handle portion.

[0444] Example 105. The method of any example herein, particularly example 104, wherein the depressing the proximal latch portion comprises pivoting the safety latch so as to release a tooth of the safety latch from a recess of a distal support body of the first handle portion.

[0445] Example 106. The method of any example herein, particularly any one of examples 102 to 105, further comprising, after the retrieving the anchor device and the needle from the patient’s body, advancing a dilation apparatus comprising an expansion member to the target tissue.

[0446] Example 107. The method of any example herein, particularly example 106, wherein the advancing the dilation apparatus comprises inserting the expansion member into the delivery catheter and advancing the expansion member through the delivery catheter.

[0447] Example 108. The method of any example herein, particularly example 107, wherein the inserting the expansion member into the delivery catheter comprises advancing the expansion member through a valve assembly of the first handle portion.

[0448] Example 109. The method of any example herein, particularly example 108, wherein the advancing the dilation apparatus comprises positioning the expansion member inside the pilot puncture, in a compacted state of the expansion member.

[0449] Example 110. The method of any example herein, particularly example 109, further comprising, prior to the positioning the expansion member inside the pilot puncture, passing a dilator of the dilation apparatus through the pilot puncture, thereby further expanding the pilot puncture.

[0450] Example 111. The method of any example herein, particularly example 110, wherein the dilator comprises a dilator tapering portion terminating at a dilator distal end.

[0451] Example 112. The method of any example herein, particularly example 111, wherein the advancing the dilation apparatus comprises advancing the dilator through the valve assembly.

[0452] Example 113. The method of any example herein, particularly example 112, wherein the advancing the dilator through the valve assembly comprises advancing tear-away sleeve disposed around the dilator, through the valve assembly.

[0453] Example 114. The method of any example herein, particularly example 113, wherein the tear-away sleeve comprises a sleeve body extending distally from a proximal portion of the tear-away sleeve.

[0454] Example 115. The method of any example herein, particularly example 114, wherein the sleeve body is disposed around the dilator and the expansion member.

[0455] Example 116. The method of any example herein, particularly example 114 or 115, wherein a distal end of the sleeve body is axially aligned with or distal to the dilator distal end.

[0456] Example 1 17. The method of any example herein, particularly any one of examples 1 14 to 116, further comprising, after the advancing tear-away sleeve, positioning the dilator distal to the valve assembly and positioning the proximal portion of the tear-away sleeve proximal to the first handle portion.

[0457] Example 118. The method of any example herein, particularly example 117, wherein the positioning the dilator distal to the valve assembly further comprises positioning the expansion member distal to the valve assembly.

[0458] Example 119. The method of any example herein, particularly example 117 or 118, further comprising, after the positioning the dilator and the proximal portion of the tear-away sleeve, tearing at least one weakened line extending along the sleeve body; and removing the tear-away sleeve from the dilation apparatus and the first handle portion.

[0459] Example 120. The method of any example herein, particularly example 119, wherein the at least one weakened line comprises two weakened lines which are diametrically opposite to each other, and wherein the tearing comprises splitting the sleeve body to two halves by pulling opposite sides of the proximal portion of the tear-away sleeve radially outwards, away from each other.

[0460] Example 121. The method of any example herein, particularly example 119, wherein the at least one weakened line extends helically along the sleeve body, and wherein the tearing comprises forming a helically spiraling strip.

[0461] Example 122. The method of any example herein, particularly any one of examples 119 to 121, wherein the at least one weakened line is formed by laser etching.

[0462] Example 123. The method of any example herein, particularly example 120, wherein the two weakened lines are formed along elongated folds of the sleeve body when temporarily compressed to a flattened configuration.

[0463] Example 124. The method of any example herein, particularly any one of examples 109 to 123, further comprising forming a tissue opening inside the target tissue by expanding the expansion member.

[0464] Example 125. The method of any example herein, particularly example 124, further comprising, after the forming the tissue opening, compressing the expansion member.

[0465] Example 126. The method of any example herein, particularly example 125, further comprising, after the compressing the expansion member, retrieving the dilation apparatus.

[0466] Example 127. The method of any example herein, particularly example 126, wherein the expansion member is a first balloon mounted on a first balloon catheter of the dilation apparatus, wherein the compacted state of the expansion member is a deflated state of the first balloon, wherein the expanding the expansion member comprises inflating the first balloon, and wherein the compressing the expansion member comprises deflating the first balloon.

[0467] Example 128. The method of any example herein, particularly example 126 or 127, wherein the target tissue is a host leaflet of a host valvular structure.

[0468] Example 129. The method of any example herein, particularly example 128, further comprising, after the retrieving the dilation apparatus, advancing a replacement valve delivery apparatus comprising a guest prosthetic valve, to the host valvular structure.

[0469] Example 130. The method of any example herein, particularly example 129, further comprising positioning the guest prosthetic valve in a radially compressed state thereof within the host valvular structure, and radially expanding the guest prosthetic valve.

[0470] Example 131. The method of any example herein, particularly example 130, wherein the positioning the guest prosthetic valve within the host valvular structure comprises positioning the guest prosthetic valve within the leaflet opening.

[0471] Example 132. The method of any example herein, particularly example 130, 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 structure.

[0472] Example 133. The method of any example herein, particularly any one of examples 130 to 132, wherein the radially expanding the guest prosthetic valve comprises inflating a second balloon of the replacement valve delivery apparatus, over which the guest prosthetic valve is disposed.

[0473] Example 134. The method of any example herein, particularly any one of examples 130 to 132, wherein the radially expanding the guest prosthetic valve comprises actuating a mechanical actuator of the guest prosthetic valve.

[0474] Example 135. The method of any example herein, particularly any one of examples 130 to 132, 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.

[0475] Example 136. The method of any example herein, particularly any one of examples 82 to 125, wherein the target tissue is a host leaflet of a host valvular structure.

[0476] Example 137. The method of any example herein, particularly any one of examples 128 to 136, wherein the host valvular structure is a valvular structure of a native heart valve.

[0477] Example 138. The method of any example herein, particularly example 137, wherein the native heart valve is an aortic valve.

[0478] Example 139. The method of any example herein, particularly any one of examples 128 to 1 6, wherein the host valvular structure is a valvular structure of a previously implanted prosthetic valve.

[0479] Example 140. A tissue perforation apparatus comprising: a first handle portion comprising a delivery catheter, wherein the delivery catheter is coupled to and extending distally from the first handle portion; and a second handle portion comprising an anchor shaft, an anchor coupled to a distal end of the anchor shaft, a needle shaft, and a needle head formed at a distal end of the needle shaft, wherein the anchor shaft is coupled to and extending distally from the second handle portion, wherein the second handle portion is releasably attachable to the first handle; and wherein the anchor shaft extends through the delivery catheter when the second handle portion is coupled to the first handle portion.

[0480] Example 141. The apparatus of any example herein, particularly example 140, wherein the needle shaft extends through the anchor shaft.

[0481] Example 142. The apparatus of any example herein, particularly any one of examples 140 to 141, wherein the second handle portion comprises an anchor control knob, and wherein the anchor shaft is configured to rotate upon actuation of the anchor control knob.

[0482] Example 143. The apparatus of any example herein, particularly any one of examples 140-142, wherein the anchor is a helical anchor.

[0483] Example 144. A method comprising: advancing a tissue perforation apparatus to a target tissue inside a patient, wherein the tissue perforation apparatus comprises a first handle portion and a second handle portion releasably attached to the first handle portion, wherein the first handle portion comprises a delivery catheter, wherein the second handle portion comprises an anchor device extending through the delivery catheter; anchoring the anchor device to the target tissue; and forming a pilot puncture in the target tissue.

[0484] Example 145. The method of any example herein, particularly example 144, wherein the second handle portion comprises an anchor control knob, wherein the anchor device comprises an anchor shaft and an anchor head at a distal end of the anchor shaft, and wherein the anchoring the anchor device to the target tissue comprises rotating the anchor control knob, thereby causing the anchor shaft and the anchor head to rotate and penetrate the target tissue.

[0485] Example 146. The method of any example herein, particularly any one of examples 144 to 145, wherein the second handle portion comprises a needle advancement knob, and wherein the forming the pilot puncture in the target tissue comprises rotating the needle advancement knob, which causes distal axial movement of the needle relative to the anchor device and through the target tissue.

[0486] Example 147. A dilation apparatus comprising: a balloon catheter defining a balloon catheter lumen; a balloon mounted on the balloon catheter and in fluid communication with the balloon catheter lumen, the balloon configured to transition between deflated and inflated states thereof; a dilator distal to the balloon, the dilator comprising a dilator tapering portion terminating at a dilator distal end; and a tear-away sleeve comprising: a proximal portion; a sleeve body extending distally from the proximal portion and terminating at a distal end; and at least one weakened line extending along the sleeve body; wherein the at least one weakened line is configured to tear when a tearing force is applied thereto by the proximal portion.

[0487] Example 148. The apparatus of any example herein, particularly example 147, wherein the distal end of the sleeve body is axially aligned with or distal to the dilator distal end.

[0488] Example 149. The apparatus of any example herein, particularly example 147 or 148, wherein the proximal portion and the sleeve body are integrally formed.

[0489] Example 150. The apparatus of any example herein, particularly any one of examples 147 to 149, wherein the at least one weakened line further extends along at least part of the proximal portion.

[0490] Example 151. The apparatus of any example herein, particularly any one of examples 147 to 149, wherein the proximal portion comprises at least one slit.

[0491] Example 152. The apparatus of any example herein, particularly example 151, wherein the at least one slit is circumferentially aligned with the at least one weakened line.

[0492] Example 153. The apparatus of any example herein, particularly example 151 or 152, wherein the at least one slit extends continuously from the at least one weakened line.

[0493] Example 154. The apparatus of any example herein, particularly any one of examples 147 to 153, wherein the proximal portion is flared radially outwards in the proximal direction.

[0494] Example 155. The apparatus of any example herein, particularly any one of examples 147 to 154, wherein the at least one weakened line comprises a thinned line.

[0495] 156. Example 156. The apparatus of any example herein, particularly any one of examples 147 to 155, wherein the at least one weakened line comprises two axially extending weakened lines.

[0496] Example 157. The apparatus of any example herein, particularly example 156, wherein the two weakened lines are diametrically opposite to each other.

[0497] Example 158. The apparatus of any example herein, particularly example 156 or 157, wherein the sleeve body is configured to split to two halves when the two weakened lines are torn.

[0498] Example 159. The apparatus of any example herein, particularly any one of examples 156 to 158, further comprising two tabs coupled to diametrically opposite sides of the proximal portion.

[0499] Example 160. The apparatus of any example herein, particularly any one of examples 147 to 155, wherein the at least one weakened line extends helically along the sleeve body.

[0500] 161. Example 161. The apparatus of any example herein, particularly any one of examples 147 to 160, wherein the at least one weakened line is formed by laser etching.

[0501] Example 162. The apparatus of any example herein, particularly any one of examples 156 to 159, wherein the two weakened lines are formed along elongated folds of the sleeve body when temporarily compressed to a flattened configuration.

[0502] Example 163. The apparatus of any example herein, particularly any one of examples 147 to 162, further comprising a dilator shaft extending proximally from the dilator.

[0503] Example 164. The apparatus of any example herein, particularly example 163, wherein the dilator shaft extends through the balloon catheter lumen.

[0504] Example 165. The apparatus of any example herein, particularly any one of examples 147 to 164, wherein the balloon is attached at a proximal end thereof to the balloon catheter, and at a distal end of the balloon to the dilator.

[0505] Example 166. The apparatus of any example herein, particularly any one of examples 147 to 165, wherein a maximum diameter of the balloon, in the inflated state, is not greater than 12 mm.

[0506] 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.

[0507] 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: a handle comprising a first handle portion and a second handle portion releasably coupled to the first handle portion; a delivery catheter rigidly attached, at a delivery catheter proximal end portion thereof, to the first handle portion; an anchor device comprising: an anchor shaft coupled to the second handle portion and configured to rotate upon actuation of an anchor control knob of the second handle portion; and a helical anchor head distal to the anchor shaft; a needle comprising: a needle shaft coupled to the second handle portion and configured to be axially moved relative to the anchor shaft upon actuation of a needle advancement knob of the second handle portion; a needle head at a distal end of the needle shaft; and wherein the needle shaft extends through the anchor shaft; and wherein the anchor shaft extends through the delivery catheter when the second handle portion is coupled to the first handle portion.

2. The apparatus of claim 1, wherein the second handle portion and the first handle portion are axially movable relative to each other.

3. The apparatus of claim 1 or 2, wherein the second handle portion comprises an extension body comprising: a distal section extending between an inner surface of a distal housing of the first handle portion and an outer surface of a distal support body of the first handle portion, when the second handle portion is coupled to the first handle portion; an intermediate section axially aligned with the anchor control knob; a proximal section extending into a proximal housing of the second handle portion; and an extension body bore extending through the distal section, the intermediate section, and the proximal section.

4. The apparatus of claim 3, wherein the needle advancement knob comprises a lead member defining a lead bore, and wherein the needle shaft is rigidly attached to a carriage of the second handle portion, wherein the carriage resides inside the lead bore and is axially movable within the lead bore.

5. The apparatus of claim 4, wherein the second handle portion further comprises a safety knob movable between a locking position and an unlocking position, wherein the safety knob is configured to prevent rotational movement of the needle advancement knob in the locking position, and allow rotational movement of the needle advancement knob in the unlocking position.

6. The apparatus of claim 5, wherein the safety knob is biased to the locking position.

7. The apparatus of any one of claims 3 to 6, wherein the first handle portion further comprises a valve assembly positioned inside the distal support body.

8. The apparatus of claim 7, wherein the valve assembly comprises a cross-slit valve, a disc valve distal to the cross-slit valve, and a hemostatic valve distal to the disc valve.

9. The apparatus of any one of claims 3 to 8, wherein the first handle portion further comprises an engagement knob configured to control engagement of the first handle portion with the second handle portion.

10. The apparatus of claim 9, wherein the engagement knob is rotatable relative to the distal housing, and wherein the first handle portion further comprises a plurality of locking balls, each locking ball residing in a radial hole extending from an outer surface of the distal housing to the inner surface of the distal housing.

11. The apparatus of claim 10, wherein the distal section of the extension body comprises a plurality of notches configured to accept the plurality of locking balls therein.

12. The apparatus of any one of claims 10 to 11, wherein the engagement knob is configured to move the handle between a connected configuration, by radially pressing the locking balls against the distal section of the extension body in a manner that prevents movement between the second handle portion and the first handle portion, and a released configuration, by allowing the locking balls to be radially spaced from the distal section of the extension body.

13. The apparatus of claim 10, wherein the engagement knob further comprises a knob internal thread, and wherein the distal section of the extension body comprises a body outer thread configured to threadedly engage with the knob internal thread.

14. The apparatus of claim 13, wherein, when the body outer thread is threadedly engaged with the knob internal thread, rotation of the engagement knob facilitates axial movement of the second handle portion relative to the first handle portion.

15. The apparatus of any one of claims 13 to 14, wherein the second handle portion further comprises a safety latch coupled to the distal section of the extension body, the safetylatch comprising a proximal latch portion, a distal latch portion, and a tooth extending radially from the distal latch portion.

16. A method comprising: advancing a distal portion of a tissue perforation apparatus, over a guidewire, inside a patient's body to a target tissue, wherein the tissue perforation apparatus comprises a handle having a first handle portion and a second handle portion releasably attached to the first handle portion, a delivery catheter attached to the first handle portion, an anchor device having an anchor shaft coupled to the second handle portion and extending through the delivery catheter, and a needle coupled to the second handle portion and extending through the anchor shaft; anchoring a helical anchor head of the anchor device to a target tissue, by rotating an anchor control knob of the second handle portion in a first rotational direction of the anchor control knob, thereby causing the anchor shaft and the helical anchor head to rotate therewith; and forming a pilot puncture in the target tissue by rotating a needle advancement knob of the second handle portion in a first rotational direction of the needle advancement knob, which causes distal axial movement of the needle relative to the anchor device.

17. The method of claim 16, further comprising, after the forming the pilot puncture, retracting the needle from the pilot puncture.

18. The method of any one of claims 16 to 17, further comprising, releasing the helical anchor head from the target tissue.

19. The method of claim 18, further comprising, after the releasing the helical anchor head, retrieving the anchor device and the needle from the patient’s body, while maintaining the delivery catheter in position.

20. The method of claim 19, wherein the retrieving the anchor device and the needle comprises releasing the second handle portion from the first handle portion and proximally pulling the second handle portion away from the first handle portion.

21. The method of claim 20, further comprising, after the retrieving the anchor device and the needle from the patient's body, advancing a dilation apparatus comprising an expansion member to the target tissue.

22. The method of claim 21, wherein the advancing the dilation apparatus comprises inserting the expansion member into the delivery catheter and advancing the expansion member through the delivery catheter.

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