Tissue perforation apparatus 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 and a needle coupled to an anvil comprised in the handle. The handle further includes a plunger proximal to the handle and a biasing member configured to distally bias the plunger. The handle can further include a sleeve configured to move between a locking configuration, in which the plunger is axially immovable relative to the sleeve, and a release configuration, in which the anvil is allowed to axially move relative to the sleeve. When the plunger is positioned in a proximal position thereof, and the biasing member is in a loaded state against the plunger, moving the sleeve from the locking configuration to the release configuration allows the biasing member to distally urge the plunger towards the anvil.

Description

TISSUE PERFORATION APPARATUS AND HANDLES THEREOFCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 573,958, filed April 3, 2024, which is incorporated by reference herein.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 impaction mechanisms.BACKGROUND

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

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

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

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

[0007] In one of its basic configurations, a tissue perforation apparatus comprises a handle comprising an anvil and a plunger, and a needle coupled to the anvil. 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 anvil can optionally define an anvil proximal surface.

[0009] In some examples, the plunger can optionally be proximal to the anvil.

[0010] In some examples, the needle can optionally extend from the anvil.

[0011] In some examples, the handle can comprise a sleeve optionally configured to move between a locking configuration, in which the plunger is axially immovable relative to the sleeve, and a release configuration, in which the anvil is allowed to axially move relative to the sleeve.

[0012] In some examples, the handle can comprise a plunger biasing member optionally configured to distally bias the plunger.

[0013] In some examples, when the plunger is positioned in a proximal position thereof, and the plunger biasing member is in a loaded state against the plunger, moving the sleeve from the locking configuration to the release configuration can optionally allow the plunger biasing member to distally urge the plunger towards the anvil.

[0014] In some examples, when the plunger is distally urged by the plunger biasing member towards the anvil, it can optionally strike against the anvil at an impact force that can result in distal movement of the anvil and the needle coupled thereto.

[0015] In some examples, the handle can comprise a support body defining a body lumen, wherein the anvil and the plunger can optionally extend through the body lumen

[0016] In some examples, the handle optionally comprises a preload adjustment knob, wherein the plunger biasing member can be disposed between the plunger and an inner step of the preload adjustment knob.

[0017] In some examples, the sleeve can optionally be disposed around the support body.

[0018] In some examples, the handle optionally comprises a plurality of locking balls, each locking ball residing in a radial hole optionally extending through the support body.

[0019] In some examples, each of the plurality of locking balls can optionally be biased radially outwards in a free state thereof.

[0020] In some examples, the sleeve can comprise a narrowed segment optionally configured to be axially aligned with and radially press the locking balls against the plunger in the locking configuration.

[0021] In some examples, the plunger can optionally be configured to axially move relative to the support body, to axially move the narrowed segment away from the locking balls and allow locking balls to be radially spaced from the plunger in the release configuration.

[0022] In some examples, the handle can comprise a sleeve biasing member, optionally configured to bias the sleeve to the locking configuration.

[0023] In some examples, the handle optionally comprises a lever pivotably hinged to the sleeve.

[0024] In some examples, the handle can comprise a lever biasing member configured to bias a distal end portion of the lever radially outwards relative to the sleeve.

[0025] In some examples, the lever can optionally be configured to prevent proximal retraction of the sleeve when the distal end portion of the lever is biased radially outwards.

[0026] In some examples, the support body optionally comprises a guide slot extending between a slot distal end and a slot proximal end.

[0027] In some examples, the handle optionally comprises an axial slider comprising a protrusion extending into the guide slot.

[0028] In some examples, the axial slider can optionally be axially movable between the slot proximal end and a distal-most position of the axial slider which is closer to the slot distal end.

[0029] In some examples, when the axial slider is in the distal-most position, the protrusion of the axial slider can optionally be configured to prevent distal translation of the plunger past the protrusion.

[0030] In some examples, when the protrusion of the axial slider is in contact with the plunger, proximal movement of the axial slider can optionally be configured to proximally drag the plunger therewith.

[0031] In some examples, the handle can comprise an adjustment knob distal to the axial slider, the adjustment knob optionally configured to axially adjust the distal-most position of the axial slider.

[0032] In some examples, the handle can comprise a translation restrictor comprising an internal extension which can be distal to a stopper of the anvil, wherein the internal extension can optionally be configured to arrest distal movement of the anvil when the stopper contacts the internal extension.

[0033] In one of its basic configurations, a tissue perforation apparatus comprises a handle comprising an anvil and a hammer, and an anchor device comprising a helical anchor head. 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.

[0034] In some examples, the anvil can optionally define an anvil lumen.

[0035] In some examples, the anvil can comprise at least one anvil lug.

[0036] In some examples, the hammer can comprise at least one hammer lug.

[0037] In some examples, the handle can comprise a biasing member optionally configured to distally bias the hammer towards the at least one anvil lug.

[0038] In some examples, the handle can comprise an anchor control knob optionally configured to rotate the hammer.

[0039] In some examples, the handle can comprise a needle advancement knob.

[0040] In some examples, the needle advancement knob can optionally be proximal to the anchor control knob.

[0041] In some examples, the anchor device can comprise an anchor shaft optionally extending proximally from the helical anchor head.

[0042] In some examples, the anchor shaft can be optionally attached to the anvil.

[0043] In some examples, the anchor shaft can be optionally configured to axially and rotatably move along with the anvil.

[0044] In some examples, the tissue perforation apparatus comprises a needle.

[0045] In some examples, the needle comprises a needle shaft optionally coupled to the handle.

[0046] In some examples, the needle shaft can be optionally configured to be axially moved relative to the anchor shaft upon actuation of the needle advancement knob.

[0047] In some examples, the needle comprises a needle head at a distal end of the needle shaft.

[0048] In some examples, upon actuation of the anchor control knob, the hammer can be optionally configured to impart rotational impact force to the anvil.

[0049] In some examples, the handle can comprise a support body defining a support surface, and wherein the biasing member extends between the support surface and the hammer.

[0050] In some examples, the hammer optionally comprises a hammer bore.

[0051] In some examples, the anvil optionally comprises an anvil proximal portion extending into the hammer bore.

[0052] In some examples, the hammer optionally comprises a hammer gear comprising outer gear teeth disposed around the circumference of a hammer proximal portion of the hammer.

[0053] In some examples, the anchor can optionally control knob comprises inner gear teeth.

[0054] In some examples, rotation of the anchor control knob can optionally be configured to rotate the hammer.

[0055] In some examples, outer gear teeth of each of the one or more idler gears can optionally be meshed with the inner gear teeth of the anchor control knob and with the outer gear teeth of the hammer gear.

[0056] In one of its basic methods, a tissue perforation method comprises positioning a tissue perforating apparatus proximate 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.

[0057] In some examples, the tissue perforating apparatus optionally comprises a delivery catheter.

[0058] In some examples, the tissue perforating apparatus optionally comprises a needle.

[0059] In some examples, the tissue perforating apparatus optionally comprises a sleeve.

[0060] In some examples, the sleeve can optionally be movable between a locking configuration and a release configuration.

[0061] In some examples, the method can comprise anchoring a distal end of the delivery catheter to the target site.

[0062] In some examples, the method comprises forming a pilot puncture on the target tissue optionally by actuating the sleeve of the leaflet perforating apparatus to move the sleeve from the locking configuration to the release configuration.

[0063] In some examples, the sleeve, when in the release configuration, can optionally allow distal movement of the plunger towards the needle, which optionally causes distal movement of the needle toward the target tissue.

[0064] In one of its basic configurations, a tissue perforation apparatus comprises a needle and a handle comprising a sleeve and a plunger. 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.

[0065] In some examples, the sleeve can be optionally configured to move between a locking configuration and a release configuration.

[0066] In some examples, the plunger is axially immovable relative to the sleeve in the locking configuration.

[0067] In some examples, the plunger is axially moveable relative to the sleeve when the sleeve is in the release configuration.

[0068] In some examples, moving the sleeve from the locking configuration to the release configuration can optionally allow the plunger to move distally toward and strike the needle to cause distal movement of the needle toward a target tissue.

[0069] 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

[0070] 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 thepurpose 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:

[0071] Fig. 1 is a sectional view of an aortic root.

[0072] 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.

[0073] Fig. 2B shows the implanted prosthetic heart valve of Fig. 1 A as viewed from the ascending aorta, according to an example.

[0074] Fig. 3 shows a valve-in- valve implantation within the native aortic valve of Fig. 1, according to an example.

[0075] Fig. 4 illustrates an exemplary tissue perforation apparatus that includes a handle and a hollow needle extending distally therefrom.

[0076] Fig. 5 is a perspective view of a distal portion of the handle.

[0077] Figs. 6A-6G are cross-sectional side views of an exemplary handle in different states thereof.

[0078] Figs. 7A-7C are perspective views of handle having a safety mechanism, in different states thereof.

[0079] Figs. 8A-8C are cross-sectional view of a proximal portion of the handle corresponding to the respective states shown in Figs. 7A-7C.

[0080] Fig. 9 illustrates an exemplary tissue perforation apparatus that includes a hollow needle 210 and an anchor device 230 coupled to and extending distally from a handle.

[0081] Fig. 10 is a cross-sectional view of a handle that includes a rotational impact mechanism.

[0082] Fig. 11 is a perspective view of an anvil of the rotational impact mechanism.

[0083] Fig. 12 is a perspective view of a hammer of the rotational impact mechanism.

[0084] Fig. 13 is a cross-sectional view taken along line 13-13 of Fig. 10.

[0085] Figs. 14A-14D show a rotational impact mechanism in different states thereof.

[0086] Fig. 15 shows an exemplary stabilized tissue modification system which includes a steerable delivery apparatus through which the tissue perforation apparatus extends.

[0087] Figs. 16A-16F illustrate steps in an exemplary method for creating a pilot puncture in the leaflet.

[0088] Fig. 17 shows an exemplary dilation apparatus of the system extending through a delivery catheter that extends through the steerable delivery apparatus.

[0089] Figs. 18A-18E illustrate steps in an exemplary method for forming a leaflet opening.

[0090] Fig. 18F is a simplified side view of a guest prosthetic valve positioned in a crimped configuration inside the leaflet opening formed within the existing valvular structure.

[0091] Fig. 18G is a simplified side view of the guest prosthetic valve of Fig. 18F expanded inside the existing valvular structure.

[0092] Fig. 19A shows the hole-dilation balloon positioned within a pilot puncture of the host leaflet in a deflated state.

[0093] Fig. 19B shows the hole-dilation balloon of Fig. 19A inflated within the host leaflet.

[0094] Fig. 19C shows the guest prosthetic valve positioned in the leaflet opening after removal of the hole-dilating balloon of Fig. 19B.

[0095] Fig. 20A is a perspective view of a host prosthetic valve subsequent to forming a leaflet opening thereof.

[0096] Fig. 20B is a perspective view of a guest prosthetic valve expanded within a leaflet opening of a host prosthetic valve.DETAILED DESCRIPTION

[0097] 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.

[0098] 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 inconjunction 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.

[0099] 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.

[0100] 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”.

[0101] 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.

[0102] 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.

[0103] 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 ororiented 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.

[0104] The terms “axial direction”, “radial direction”, and “circumferential direction” have been used herein to describe the arrangement and assembly of components relative to the geometry of the frame of the prosthetic valve, or the geometry of an inflatable balloon that can be used to expand a prosthetic valve. Such terms have been used for convenient description, but the disclosed examples are not strictly limited to the description. Tn 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.

[0105] 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.

[0106] 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.

[0107] 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.

[0108] 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.

[0109] 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 structureor 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.

[0110] 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.

[0111] Described herein are devices and methods for implanting prosthetic valves and modifying leaflets of an existing valvular structure in a patient’s heart. Prior to or during implantation of the prosthetic heart valve within the existing valvular structure, each device, such as a delivery apparatus that can optionally carry a prosthetic valve, can be provided in the ascending aorta of a patient and can be used to pierce, lacerate, slice, tear, cut or otherwise modify a leaflet or commissure of the existing valvular structure. In some examples, the existing valvular structure can be a native aortic valve (for example, normal or abnormal, such as bicuspid aortic valve (BAV)) or a prosthetic valve previously implanted in the native aortic valve. The modification can avoid, or at least reduce the likelihood of, issues that leaflets of the existing valvular structure might otherwise cause once the prosthetic heart valve has been fully installed, for example, obstruction of blood flow to the coronary arteries, improper mounting due to a non-circular valve cross-section, and / or restricted access to the coronary arteries if subsequent intervention is required. While described with respect to aortic valve, it should be understood that the disclosed examples can be adapted to deliver devices that can modify existing valvular structure, and in some implementations, implant prosthetic devices, to and / or in any of the native annuluses of the heart (for example, the aortic, pulmonary, mitral, and tricuspid annuluses), and can be used with any of various delivery approaches (for example, retrograde, antegrade, transseptal, transventricular, transatrial, etc.).

[0112] 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, thenative aortic valve 20 has three leaflets (only two leaflets are visible in the simplified illustration of Fig. 1), but aortic valves with fewer than three leaflets are possible. The leaflets 30 are supported at native commissures by the aortic annulus 24, which is a ring of fibrous tissue at the transition point between the left ventricle 32 and the aortic root 22. The leaflets 30 can cycle between open and closed positions (the closed position is shown in Fig. 1) to regulate flow of blood from the left ventricle 32 to the ascending aorta 26. Branching off the aortic root 22 are the coronary arteries 34, 36. The coronary artery ostia 42, 44 are the openings that connect the aortic root 22 to the coronary arteries 34, 36.

[0113] Figs. 2A-2B show an exemplary prosthetic valve 100 that can be implanted in a native heart valve, such as the native aortic valve 20 of Fig. 1. The term “prosthetic valve”, as used herein, refers to any type of a prosthetic valve deliverable to a patient's target site over a catheter, which is radially expandable and compressible between a radially compressed, or crimped, state, and a radially expanded state. Thus, the prosthetic valve can be crimped on or retained by an implant delivery apparatus (not shown) in the radially compressed state during delivery, and then expanded to the radially expanded state once the prosthetic valve reaches the implantation site. The expanded state may include a range of diameters to which the valve may expand, between the compressed state and a maximal diameter reached at a fully expanded state. Thus, a plurality of partially expanded states may relate to any expansion diameter between radially compressed or crimped state, and maximally expanded state. A prosthetic valve of the current disclosure (for example, prosthetic valve 100) may include any prosthetic valve configured to be mounted within the native aortic valve, the native mitral valve, the native pulmonary valve, and the native tricuspid valve.

[0114] It is understood that the prosthetic valves disclosed herein may be used with a variety of implant delivery apparatuses. Balloon expandable valves generally involve a procedure of inflating a balloon within a prosthetic valve, thereby expanding the prosthetic valve within the desired implantation site. Once the valve is sufficiently expanded, the balloon is deflated and retrieved along with a delivery apparatus (not shown). Self-expandable valves include a frame that is shape-set to automatically expand as soon an outer retaining shaft or capsule (not shown) is withdrawn proximally relative to the prosthetic valve. Mechanically expandable valves are a category of prosthetic valves that rely on a mechanical actuation mechanism for expansion. The mechanical actuation mechanism usually includes a plurality of expansion and locking assemblies (such as the prosthetic valves described in U.S. Patent No. 10,603,165, International Application No. PCT / US 2021 / 052745 and U.S. Provisional Application Nos. 63 / 85,947 and 63 / 209904, each of which is incorporated herein by reference in its entirety), releasably coupledto respective actuation assemblies of a delivery apparatus, controlled via a handle (not shown) for actuating the expansion and locking assemblies to expand the prosthetic valve to a desired diameter. The expansion and locking assemblies may optionally lock the valve's diameter to prevent undesired recompression thereof, and disconnection of the actuation assemblies from the expansion and locking assemblies, to enable retrieval of the delivery apparatus once the prosthetic valve is properly positioned at the desired site of implantation.

[0115] Figs. 2A-2B show an example of a prosthetic valve 100, which can be a balloon expandable valve or any other type of valve, illustrated in an expanded state. The prosthetic valve 100 can comprise an outflow end 106 and an inflow end 104. In some instances, the outflow end 106 is the proximal end of the prosthetic valve 100, and the inflow end 104 is the distal end of the prosthetic valve 100. Alternatively, depending for example on the delivery approach of the valve, the outflow end can be the distal end of the prosthetic valve, and the inflow end can be the proximal end of the prosthetic valve.

[0116] 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.

[0117] The term “inflow”, as used herein, refers to a region of the prosthetic valve through which the blood flows into the prosthetic valve 100.

[0118] 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.

[0119] 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.

[0120] The terms “longitudinal” and “axial”, as used herein, refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined.

[0121] The prosthetic valve 100 comprises an annular frame 102 movable between a radially compressed configuration and a radially expanded configuration, and a valvular structure 113 that comprises prosthetic valve leaflets 114 mounted within the frame 102. The frame 102 can be made of various suitable materials, including plastically-deformable materials such as, but not limited to, stainless steel, a nickel-based alloy (for example, a nickel-cobalt-chromium alloy such as MP35N alloy), polymers, or combinations thereof. When constructed of a plastically- deformable materials, the frame 102 can be crimped to a radially compressed state on a ballooncatheter, and then expanded inside a patient by an inflatable balloon or equivalent expansion mechanism. Alternatively or additionally, the frame 102 can be made of shape-memory materials such as, but not limited to, nickel titanium alloy (for example, Nitinol). When constructed of a shape-memory material, the frame 102 can be crimped to a radially compressed state and restrained in the compressed state by insertion into a shaft or equivalent mechanism of a delivery apparatus.

[0122] In the example illustrated in Figs. 2A-2B, the frame 102 is an annular, stent-like structure comprising a plurality of intersecting struts 108. In this application, the term “strut” encompasses axial struts, angled struts, laterally extendable struts, commissure windows, commissure support struts, support posts, and any similar structures described by U.S. Pat. Nos. 7,993,394 and 9,393,110, which are incorporated herein by reference. A strut 108 may be any elongated member or portion of the frame 102. The frame 102 can include a plurality of strut rungs that can collectively define one or more rows of cells 110. The frame 102 can have a cylindrical or substantially cylindrical shape having a constant diameter from the inflow end 104 to the outflow end 106 as shown, or the frame can vary in diameter along the height of the frame, as disclosed in US Pat. No. 9,155,619, which is incorporated herein by reference.

[0123] The struts 108 can include a plurality of angled struts and vertical or axial struts. At least some of the struts 108 can be pivotable or bendable relative to each other, so as to permit frame expansion or compression. For example, the frame 102 can be formed from a single piece of material, such as a metal tube, via various processes such as, but not limited to, laser cutting, electroforming, and / or physical vapor deposition, while retaining the ability to collapse / expand radially in the absence of hinges and like.

[0124] A valvular structure 113 of the prosthetic valve 100 can include a plurality of prosthetic valve leaflets 114 (for example, three leaflets), positioned at least partially within the frame 102, and configured to regulate flow of blood through the prosthetic valve 100 from the inflow end 104 to the outflow end 106. While three leaflets 114 arranged to collapse in a tricuspid arrangement, are shown in the example illustrated in Figs. 2A-2B, it will be clear that a prosthetic valve 100 can include any other number of leaflets 114. Adjacent leaflets 114 can be arranged together to form prosthetic valve commissures 116 that are coupled (directly or indirectly) to respective portions of the frame 102, thereby securing at least a portion of the valvular structure 113 to the frame 102. The prosthetic valve leaflets 114 can be made from, in whole or part, biological material (for example, pericardium), bio-compatible synthetic materials, or other such materials. Further details regarding transcatheter prosthetic valves, including the manner in which leaflets 114 can be coupled to the frame 102 of the prostheticvalve 100, can be found, for example, in U.S. Patent Nos. 6,730,118, 7,393,360, 7,510,575, 7,993,394, 8,652,202, and 11,135,56, all of which are incorporated herein by reference in their entireties.

[0125] In some examples, the prosthetic valve 100 can comprise at least one skirt or sealing member. For example, the prosthetic valve 100 can include an inner skirt (not shown in Fig. 2A-2B), which can be secured to the inner surface of the frame 102. Such an inner skirt can be configured to function, for example, as a sealing member to prevent or decrease perivalvular leakage. An inner skirt can further function as an anchoring region for leaflets 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 be disposed around and attached to the inner surface of frame 102, while the leaflets can be sutured to the inner skirt along a scalloped line (not shown). An inner skirt can be coupled to the frame 102 via sutures or another form of coupler.

[0126] The prosthetic valve 100 can comprise, in some examples, an outer skirt 118 mounted on the outer surface of frame 102 (as shown in Figs. 2A-2B), configured to function, for example, as a sealing member retained between the frame 102 and the surrounding tissue of the native annulus against which the prosthetic valve is mounted, or against an inner side of a previously implanted valve in the case of ViV procedures (described further below), thereby reducing risk of paravalvular leakage (PVL) past the prosthetic valve 100. The outer skirt 118 can be coupled to the frame 102 via sutures or another form of coupler.

[0127] Any of the inner skirt and / or outer skirt can be made of various suitable biocompatible materials, such as, but not limited to, various synthetic materials (for example, PET) or natural tissue (for example pericardial tissue). In some cases, the inner skirt can be formed of a single sheet of material that extends continuously around the inner surface of frame 102. In some cases, the outer skirt 118 can be formed of a single sheet of material that extends continuously around the outer surface of frame 102.

[0128] The cells 110, defined by interconnected struts 108, define cell openings 112. While some of the cell openings 112 can be covered by the inner skirt and / or the outer skirt, at least a portion of the cell opening 112 can remain uncovered, such as cell openings 112 which are closer to the outflow end 106 of the prosthetic valve.

[0129] 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.

[0130] 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.

[0131] For an existing implanted prosthetic valve, the valvular structure may naturally degrade over time thereby requiring repair or replacement in order to maintain adequate heart functions. In a Valve- in- Valve (ViV) procedure, a new prosthetic heart valve is mounted within the existing, degrading prosthetic heart valve in order to restore proper function. Fig. 3 illustrates an exemplary hypothetical coronary artery obstruction that could occur in some cases from implantation of a prosthetic valve 100b within a previously implanted prosthetic valve 100a (for example, after a ViV procedure). In this example, the prosthetic valve 100b is the guest valve or new valve, and the prosthetic valve 100a is the host valve or old valve. In this example, the prosthetic valve 100a was previously implanted within the orifice of the native aortic valve 20. Each of the prosthetic valves 100a, 100b can have the general structure of the prosthetic valve 100 described with reference to Figs. 2A-2B, though in some examples, each of the prosthetic valves 100a, 100b can be a different type of prosthetic valve. For example, a balloon expandable guest valve 100b can be implanted inside a previously implanted mechanically expandable or self-expandable host valve 100a.

[0132] 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.

[0133] 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.

[0134] 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.

[0135] 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.

[0136] 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.

[0137] 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.

[0138] Fig. 4 illustrates an exemplary tissue perforation apparatus 300 that includes a handle 302 and a hollow needle 210 extending distally therefrom. Fig. 5 is a perspective view of a distal portion of the handle 302. Figs. 6A-6G are cross-sectional side views of the handle 302 in different states thereof. Figs. 4-6G are described herein together. The terms “tissue perforation apparatus 300” and “apparatus 300”, as used herein, are interchangeable.

[0139] The needle 210 comprises a needle head 214 and a needle shaft 220 extending proximally from the needle head 214, collectively defining a needle lumen 212, through which a guidewire (such as guidewire 80 shown in Fig. 15, for example) can extend. The needle head 214 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 214 can define an angled surface 216 terminating at a sharp needle tip 218 configured to facilitate piercing the host leaflet 10 when the needle 210 is pressed thereagainst.

[0140] In some examples, at least a portion of the needle shaft 220 comprises slits arranged in a desired pattern, such as that of known hypo-tubes, to enhance flexibility thereof. In the example illustrated in Fig. 4, at least part of the needle shaft 220, such as a distal portion 222 thereof, is shown to include a plurality of circumferential slits 224 axially spaced from each other, so as to form circumferential bands separating between adjacent circumferential slits 224, with axially extending connecting portions connecting adjacent bands. Two adjacent circumferential bands can be connected by a plurality of angularly spaced connecting portions defined between ends of corresponding circumferential slits 224. In such arrangements, the slitted portion of the needle shaft 220, such as the distal portion 222, exhibits sufficient flexibility to allow it to flex as it is pushed through a tortuous pathway without kinking or buckling, and / or to bend when passed through bent portions of the vasculature and / or through bends of a catheter is extends through.

[0141] While a specific pattern is illustrated in Fig. 4, which can be a laser cut pattern, it is to be understood that the pattern of slits 224 and / or the size of the slits 224 and / or axial distancesbetween the slits 224 can vary along the length of the corresponding slitted part of the needle shaft 220 in order to vary stiffness of the slitted part of the needle shaft 220 along its length. For example, the axial distance between adjacent slits 224 can decrease from the proximal end to the distal end of the slitted part of the needle shaft 220 to provide greater stiffness near the proximal end and greater flexibility near the distal end of the needle shaft 220.

[0142] In some examples, the needle shaft slitted portion 222 can extend along the entire length of the needle shaft 220 or at least a significant portion of a length thereof. In some examples, the needle shaft 220 can include a slitted portion 222 that includes slits, such as slits 224, and a non-slitted portion 226 extending proximally from the slitted portion 222, which can be devoid of slits, as illustrated in Fig. 4. In some examples, the slitted portion 222 and the non- slitted portion 226 of the needle shaft 220 are separate components that can be affixed to each other, and may be made from similar or different materials. For example, a laser-cut metallic tube that includes slits 224 can be used to form the slitted portion 222, while the non-slitted portion 226 can be made of a polymeric material. The slitted portion 222 can allow for increased flexibility along a distal part of the needle 210, 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 non-slitted portion 226 may be less flexible than the slitted portion 222, yet flexible enough to allow it to passively bend along curved portions of the patient's vasculature, for example.

[0143] In some examples, the slitted portion 222 extends along less than 50% of the length of the entire needle shaft 220. In some examples, the slitted portion 222 extends along less than 30% of the length of the entire needle shaft 220. In some examples, the slitted portion 222 extends along less than 25% of the length of the entire needle shaft 220. In some examples, the slitted portion 222 extends along less than 20% of the length of the entire needle shaft 220. In some examples, the needle head 214 can be continuous with and / or integrally formed with the slitted portion 222. For example, when the slitted portion 222 is formed from a metallic tube, the needle head 214 can be an integral extension of the tube, together forming a unitary component, while the needle head 214 can be devoid of slits.

[0144] In some implementations of a needle 210, the length of the needle shaft 220 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 slitted portion 222 of the needle shaft 220 to be formed as a hypotube, while the optionally longer non-slitted portion 226 is made of a polymeric material, can advantageously reduce manufacturing costs.The non-slitted portion 226 can be affixed, at its distal end, to a proximal end of the slitted portion 222, by any method known in the art such as gluing, overmolding, and the like.

[0145] While the needle shaft 220 is shown in the example illustrated in Fig. 4 to be formed of a slitted portion 222 that includes slits 224, and a non-slitted portion 226 devoid of slits, it is to be understood any exemplary needle 210 disclosed herein can be, in some examples, slitted along its entire length, such as by being made of a metallic laser-cut hypotube that defines the entirety of the needle shaft 220.

[0146] The proximal end portion 228 of the needle shaft 220 of apparatus 300 extends into and is coupled to the handle 302. During delivery through the patient's vasculature, the handle 302 can be maneuvered by an operator (for example, a clinician or a surgeon) to control movement of the needle 210. It is to be understood that apparatus 300 can include additional components which are not necessarily illustrated. In some examples, the apparatus 300 can include a shaft or catheter (not shown) disposed around the needle 210. Such a shaft or catheter can be coupled to the handle 302 and extend distally therefrom, defining a lumen through which the needle 210 can extend. In some examples, the handle 302 can further include an external housing (not shown) disposed around at least some of the components of the handle illustrated throughout Figs. 4-8C. In such examples, some components of the handle 302, such as one or more knobs or actuators thereof, can be exposed through the housing.

[0147] The handle 302 comprises an elongated support body 338 defining an outer surface 340 and a body lumen 342 extending therethrough. The support body 338 includes a distal portion 344 extending proximally from a distal end 345 of the support body 338, an intermediate portion 348 extending proximally from the distal portion 344, a transitioning portion 364 extending proximally from the intermediate portion 364, and a proximal portion 368 extending proximally from the transitioning portion 364.

[0148] In some examples, the handle 302 includes a clamp assembly 304 through which the needle shaft proximal end portion 228 can extend into the handle 302, such as into the body lumen 342. The clamp assembly 304 can be distal to the support body 338, and is configured to clamp over the needle shaft proximal end portion 228 to restrain movement of the needle 210 relative to the clamp assembly 304, such as in the axial direction.

[0149] In some examples, the clamp assembly 304 can include a clamping collar 314 disposed around a clamp member 306. In some examples, the clamp member 306 can include a chick or a collet 306. The clamping collar 314 is shown in Fig. 5 with partial transparency for illustrative purpose.

[0150] As shown in Fig. 5, a clamp member implemented as a collet 306 can include a plurality of axially extending, circumferentially spaced collet slots 308 that define a plurality of fingers 310 therebetween. In some examples, the fingers 310 are flexible. The collet 306 can extend, at least partially, through the clamping collar 314, and define an outer tapered end surface 312 at a distal end portion thereof, facing an inner tapered end surface 316 defined at a distal end portion of the clamping collar 314. In some examples, the clamping collar 314 can be threadedly engaged with the collet 306. For example, the collet 306 can include an outer threading 305, such as along a proximal portion thereof, and the clamping collar 314 can include an inner threading 315 that engages the outer threading 305 of the collet 306.

[0151] When the clamping collar 314 is rotated in a rotational direction which can be clockwise or counterclockwise, configured to result in a distal movement of the clamping collar 314 relative to the collet 306, the distal inner tapered end surface 16 of the clamping collar 314 pushes against the corresponding outer tapered end surface 312 of the collet 306, forcing the fingers 310 radially inwards against an outer surface of the needle shaft proximal end portion 228 extending therethrough. The holding force of the collet 306 against the needle 210 locks the needle 210 relative to the clamp member 306.

[0152] While a collet-like clamp member 306 is described above, it is to be understood that any reference to a clamp member 306 herein can refer to a collet-like clamp member 306 or to any other type of clamp member that can lock the needle 210 in a manner that prevents relative axial movement between the needle 210 and the clamp member 306, such that when the clamp member 306 is clamped around the needle 210, such as around the needle’s proximal end portion 228, the needle is forced to move along (for example, axially) with the clamp member 306.

[0153] The handle 302 further comprises an anvil 334 extending proximally from the clamp member 306. The anvil 334 extends through the body lumen 342, such as along the distal portion 344 of support body 338, and defines an anvil proximal surface 336 facing the proximal direction. In some examples, the anvil 334 can have a length that extends from the clamp member 306, through the entire length of the distal portion 344, and optionally protrude to some extend into the intermediate portion 348. In some examples, the anvil 334 and the clamp member 306 are integrally formed, together defining a unitary body. In some examples, the anvil 334 is rigidly coupled to the clamp member 306 using any suitable method, such as gluing, welding, clamping, and the like, such that any the anvil 334 and the clamp member 306 are configured to axially move in unison, moving the needle 210 therewith when the needle 210 is clamped thereby.

[0154] The handle 302 further comprises a plunger 440 proximal to the anvil 334. The plunger 440 is disposed inside of the body lumen 342, and is axially movable towards and away from the anvil 334. The plunger can include a head portion 444 that defines a distal surface 446 facing the anvil proximal surface 336. The head portion 444 can be also referred to as an impactor, configured to move towards and strike against the anvil 334 at an impact force that can result in a short-duration axial movement of the anvil 334. In some examples, the head portion 444 can be integrally formed with a main body 445 the plunger 440. In some examples, the head portion 444 can be a separate component affixed to the plunger’s main body 445 using any suitable method, such as gluing, welding, clamping, threads, and the like. The plunger can define a plunger outer surface 448, and include a plunger lumen 442 extending along its length, including through the head portion 444.

[0155] The plunger 440 can be configured to move between a proximal position, in which the head portion 444 is axially spaced from the anvil 334, as illustrated for example in Fig. 6A, and a distal position, in which the head portion 444 can optionally contact the anvil 334 at the moment of striking it, as shown for example in Fig. 6D. In some examples, the handle 302 can further include a lock and release mechanism configured to axially lock the plunger 440 in the proximal position, and to release the plunger 440 so as to allow axial movement thereof along the body lumen 342.

[0156] In some examples, the intermediate portion 348 of support body 338 includes one or more guide slots 350. While one guide slot 350 is visible in the cross-section views of Figs. 6A-6G, it is to be understood that any number of guide slots 350 is contemplated. The guide slot 350 can extend along at least part of the length of the intermediate portion 348, between a slot distal end 352 and a slot proximal end 354. In some examples, the slot distal end 352 can be at or distal to the axial position of the anvil proximal surface 336 prior to being impacted by the plunger. In some examples, the slot proximal end 354 can be at or proximal to the axial position of the head portion’s distal surface 446 when the plunger 440 is at the proximal position.

[0157] In some examples, the handle 302 further comprises a sleeve 400 disposed around the support body 338, proximal to the guide slot 350. The sleeve 400 can extend between a distal end 402 and a proximal end 404, and define a sleeve bore 406 through which the support body 338 extends. The sleeve can be moved between a locking configuration, in which the sleeve 400 is configured to lock the plunger 440 in its proximal position, restricting axial movement of the plunger 440 relative to the support body 338, and a release configuration, in which the plunger 440 is no longer locked and may be axially moved relative to the support body 338.

[0158] In some examples, the lock and release mechanism of handle 302 is based on locking balls 384. The handle 302 can include a plurality of locking balls 384 configured to engage with notches 450 (for example, see Fig. 6G) formed along the outer surface 448 of the plunger 440. The locking balls 384 extend through radial holes 358 of support body 338, and are radially bound, in the locked configuration of the sleeve 400, between the sleeve 400 and the plunger outer surface 448. In some examples, the locking balls 384 can be circumferentially spaced from each other. The locking balls 384 can be equally or unequally spaced from each other around the circumference of the support body 338. The number of notches 450 and their circumferential positions around the plunger 440 can match the number and circumferential positions of locking balls 384. In some examples, the radial holes 358 extend through the thickness of the support body 338, proximal to the guide slot 350.

[0159] The sleeve bore 406 can have several bore portions continuous with each other. In some examples, the sleeve bore 406 can include a first bore portion 406a (for example, see Fig. 6A) extending from the sleeve’s distal end 402, a second bore portion 406b extending proximally from the first bore portion 406a and having a smaller diameter than the first bore portion 406a, and a third bore portion 406c extending proximally from the second bore portion 406b towards the sleeve’ s proximal end 404. The third bore portion 406c has a larger diameter than the second bore portion 406b, defining an inner step 412 at the transition between the second bore portion 406b and the third bore portion 406c. The narrower diameter of the second bore portion 406b defines a narrowed segment 403 of the sleeve 400.

[0160] The outer diameter of the transitioning portion 364 of the support body 338 can be larger than the outer diameter of the intermediate portion 348, defining a first outer step 366 at the transition between the intermediate portion 348 and the transitioning portion 364. The diameter of the third bore portion 406c can be larger than the outer diameter of the intermediate portion 348, and in some examples, can closely match the outer diameter of the transitioning portion 364, such that the proximal end 404 of the sleeve 400 can be disposed around the intermediate portion 348, while the distal end 402 of the sleeve 400 can be disposed around the intermediate portion 348.

[0161] A biasing member 434 is optionally disposed inside the third bore portion 406c, optionally around the intermediate portion 348. The biasing member 434 extends between the first outer step 366 of the support body 338 and the inner step 412 of the sleeve 400, configured to distally bias the sleeve 400 to the locking configuration shown in Fig. 6A, for example. In some examples, the biasing member 434 comprises a coil compression spring, though the illustrated spring 434 can be replaced and / or additionally accompanied by other biasingmembers, such as an elastomeric body (e.g., a silicone of polyurethane component) which is compressible under external force application, and returns to its original shape when such force is removed, or any other type of biasing member configured to distally bias the sleeve 400. In some examples, the biasing member 434 can be optionally referred to as a sleeve biasing member.

[0162] The outer diameter of the proximal portion 368 of the support body 338 can be larger than the outer diameter of the transitioning portion 364, defining a second outer step 370 at the transition between the transitioning portion 364 and the proximal portion 368. The distal end 402 of the sleeve 400 can be positioned, in the locking configuration of the sleeve 400, distal to the second outer step 370.

[0163] In the distally-biased configuration of the sleeve 400, shown for example in Fig. 6A, the narrowed segment 403 of the sleeve 400 is axially aligned with the locking balls 384, thereby pushing the locking balls 384 radially inwards, forcing them into the corresponding notches 450 of the plunger 440, thereby firmly locking the plunger 440 and the sleeve 400 against each other, as shown in, for example, Fig. 6A.

[0164] As illustrated in a zoomed-in region of Fig. 6G, each radial hole 358 in which a locking ball 384 resides, can include a cylindrical portion 360 exposed at the outer surface 340 of the support body 338, having a diameter that can be similar to, or slightly greater than, the diameter of the locking ball 384, and an inner phase 362 that tapers towards the body lumen 342, to a diameter which is smaller than that of the locking ball 384. In a free state of a locking ball 384, when the locking ball 384 is not forcibly pushed radially inwards, the inner phase 362 biases the locking ball 384 radially away from the body lumen 342.

[0165] Thus, when the sleeve 400 is proximally pulled, such that the proximal end 404 of the sleeve 400 moves towards the second outer step 370, as shown in Fig. 6B, the locking balls 384 are exposed to the wider first bore portion 406a and are free to extend radially outwards, out of notches 450, such that axial movement of the plunger 440 is no longer restricted. The distance between the distal end 402 of the sleeve 400 and the second outer step 370 in the locking configuration of the sleeve 400, along which the sleeve is allowed to travel when proximally pulled, can be designed to maintain the locking balls 384 in alignment with the first sleeve bore 406a in the release configuration of the sleeve 400.

[0166] In some examples, the sleeve 400 can include a flange 408 extending radially outwards at the distal end 402, configured to allow easier grasping and pulling of the sleeve 400 to release the plunger 440. As shown in Fig. 6B for example, the sleeve 400 can be pulled against the biasing spring 434, for example by compressing the coiled spring 434 in the illustratedexample. When the pull force is no longer applied to the sleeve 400, the biasing member 434 urges it back to its distally biased position.

[0167] The proximal portion 368 of the support body 338 can include a proximal wall 374 having a proximal opening 372 aligned with the body lumen 342. In some examples, the proximal opening 372 can be aligned with the plunger lumen 442. A guidewire 80 (indicated, for example, in Fig. 15) can be inserted, through the proximal opening 372 and the plunger lumen 442, into the needle lumen 212.

[0168] In some examples, the proximal portion 368 of support body 338 further defines a body inner step 376 at the transition between the body lumen 342 to the narrower proximal opening 372. The body inner step 376 can be defined along a distal surface of the proximal wall 374. A biasing member 456 is disposed inside the body lumen 342 of the proximal portion 368, between the body inner step 376 and the plunger 440. In some examples, the plunger 440 further defines an outer step 454 at a transition between the main body 445 to a narrower proximal portion 452 of the plunger 440, such that the biasing member 456 extends between the body inner step 376 of the support body 338 and the outer step 454 of the plunger 440.

[0169] The biasing member 456 is optionally configured to distally bias the plunger 440 when the plunger is in a released state. In some examples, the biasing member 456 comprises a coil compression spring, though the illustrated spring 456 can be replaced and / or additionally accompanied by other biasing members, such as an elastomeric body (e.g., a silicone of polyurethane component) which is compressible under external force application, and returns to its original shape when such force is removed, or any other type of biasing member configured to distally bias the plunger 440 in a released state thereof, at a force sufficient to impact against the anvil 334. In some examples, the biasing member 456 can be optionally referred to as a plunger biasing member.

[0170] While the needle shaft proximal end portion 228 is shown in the example illustrated in Fig. 6A to extend proximally from the anvil 334, through the body lumen 342, into the plunger lumen 442, it is to be understood that this is shown by illustration and not limitation. In some examples, the needle 210 can terminate distal to the plunger 440, such as between the head portion 444 and the anvil proximal surface 336. In some examples, the needle 210 can terminate distal to the anvil proximal surface 336, such as within the anvil 334. In some examples, the needle 210 can terminate distal to the anvil 334, such as within the clamp member 306.

[0171] Figs. 6A-6G show different stages in an exemplary operation of the handle 302 of apparatus 300. Fig. 6A shows the configuration of the handle 302 which can be representative of its state prior to, and / or during advancement of the needle 210 to a target tissue, such as ahost leaflet 10 of a host valvular structure 12. As shown in Fig. 6A, the biasing member 456 can be preloaded, in this configuration. For example, when implemented as a coil compression spring 456, the spring 456 can be compressed between the proximal wall 374 and the plunger’s outer step 454, with the plunger 440 locked in the proximal position by the locked configuration of the sleeve 400. Due to the distally -biasing force applied by the biasing member 434, the sleeve 400 can remain in the locking configuration in a free state thereof.

[0172] Upon reaching the target tissue, such as host leaflet 10, with the needle head 214 directed towards the host leaflet 10, an operator of the apparatus 300 (e.g., clinician) can proximally pull the sleeve 400, moving it to the release configuration shown in Fig. 6B, allowing the locking balls 384 to spring radially outwards, away from the plunger 440. Since the plunger 440 in no longer locked in position, the stored energy of the pre-loaded biasing member 456 is released, urging the plunger 440 to distally slide inside the body lumen 342, as shown in Figs. 6D-6D. Fig. 6C shows the plunger 440 midway between its proximal position and the anvil 334, and Fig. 6D shows the plunger 440 in the distal position, as its head portion 444 strikes against the anvil 334, causing the anvil, along with the clamp assembly 304 and needle 210 clamped thereby, to move in the distal direction as a result of the impact force.

[0173] Since the impact force is transmitted from the head portion or impactor 444 of the plunger 440 to the anvil 334, short-duration axial translation of the needle head 214 into the tissue is achieved due to the needle 210 coupling to the anvil 334 via the clamp assembly 304, without the need to strike directly against the needle 210 itself, thereby protecting the relatively small-sized needle from being damaged by such hammering forces. Advantageously, the short duration during which the needle head 214 is distally translated to pierce through the target tissue, such as a host leaflet 10, improves accuracy by preventing the thin tissue from sliding relative to the needle tip 218. The impact force and duration can be controlled by design parameters of the biasing member 456 and the extent to which it is pre-loaded.

[0174] In some examples, the anvil 334 can include a stopper 335, which can be in the form of a protrusion 335 extending outwardly therefrom, configured to limit the axial translation of the anvil 334 and the needle 210 coupled thereto. In some examples, the handle 302 can further include a translation restrictor 318 defining an internal extension 319 extending radially inwards, distal to the distal end 345 of the support body 338. In the first position of the plunger 440 shown in Fig. 6A, prior to the anvil 334 being impacted thereby, the stopper 335 of the anvil 334 is positioned proximal to the internal extension 319 of the translation restrictor, wherein the distance between both is commensurate with the desired maximal axial translation of the needle 210.

[0175] As the plunger 440 strikes against the anvil 334, the anvil 334 is allowed to move distally, along with the needle 210, up until the stopper 335 reaches the internal extension 319, at which point further axial movement of the anvil 334 and the needle 210 coupled thereto is prevented. This mechanism can also maintain the anvil 334 inside the handle 302 in a manner that prevents it from sliding out of the body lumen 342 when subjected to high impact forces. In some examples, the internal extension 319 of the translation restrictor 318 can further assist in centralizing and stabilizing the anvil 334 as it is passed therethrough.

[0176] In some examples, the distal portion 344 of the support body 338 can include an outer threading 346 along the outer surface 340. In some examples, the translation restrictor 318 can be provided in the form of a knob that can be actuated to axially move the position of the internal extension 319 relative to the distal end 345 of the support body 338. For example, the translation restrictor 318 can include an inner threading 320 that engages the outer threading 346 of the support body’s distal portion 344, such that rotation of the translation restrictor 318 results in axial translation thereof relative to the support body 338. Thus, when the translation restrictor 318 is rotated in a rotational direction which can be clockwise or counterclockwise, it can be axially moved, along with its internal extension 319, farther from or closer to the distal end 345 of support body 338, thus adjusting the maximal distance along which the anvil 334 and the needle 210 coupled thereto, can distally move prior to engagement of the stopper 335 with the internal extension 319.

[0177] In some cases, a series of two or more impact iterations of the needle 210 may be desired, or the same apparatus 300 can be utilized to puncture through more than one leaflet 10. For example, the same apparatus 300 can be used to form a pilot puncture through one host leaflet, after which the needle and other components of the apparatus can be retracted from the first leaflet and navigated towards a second leaflet, through which the needle needs to extend as well. In such examples, there may be a need to return the handle to a configuration similar to that described above with respect to Fig. 6A, ready to be similarly utilized to form another puncture in a similar manner.

[0178] In some examples, the handle 302 further comprises an axial slider 328 disposed around the intermediate portion 348 of the support body 338. The axial slider 328 comprises at least one radial protrusion 330 extending through the guide slot 350 into the body lumen 342. In some examples, the axial slider 328 can be provided in the form of a ring-like member, configured to axially slide over the support body 338, between the distal end 352 and proximal end 354 of the guide slot 350. While one protrusion 330 is visible in the cross-section views ofFigs. 6A-6G, it is to be understood that any number of protrusions 330 is contemplated, optionally matching the number of guide slots 350.

[0179] In the initial configuration of the handle 302 shown in Fig. 6A for example, while the biasing member 456 is pre-loaded and the sleeve 400 locks the plunger 440 in the proximal position, the protrusion 330 can be positioned at distal to the anvil proximal surface 336. When the plunger 440 is released and strikes against the anvil 334, axial movement of the plunger 440 can be continued up to the point of contact between the distal surface 446 of the plunger’ s head portion 444 and the protrusion 330, as shown in Fig. 6D, such that the protrusion 330 can serve to limit axial translation of the plunger 440 inside the body lumen 342.

[0180] The axial slider 328 can be then proximally moved, as shown in Figs. 6E-6F, dragging the plunger 440 therewith. Fig. 6E shows the axial slider 328 and the plunger 440 dragged thereby, midway between the distal position and the proximal position of the plunger 440, gradually recompressing the biasing member 456, while the sleeve 400 is maintained in its proximally pulled release configuration to allow for undisturbed axial movement of the plunger 440. Fig. 6F shows the axial slider 328 closer to the slot proximal end 354, with the plunger 440 positioned in the proximal position, at which point the sleeve 400 can be released to lock the plunger 440 in position, maintaining the biasing member 456 compressed thereby.

[0181] In some examples, the narrowed segment 403 of the plunger 440 includes an angled surface 414 at the transition between the first bore portion 406a and the second bore portion 406b, as shown in Fig. 6G for example, to allow for smoother engagement against the locking balls 384 as the sleeve 400 is distally moved from the release configuration to the locking configuration, gradually contacting and pressing the locking balls 384 radially inwards, against the notches 450 of the plunger 440.

[0182] With the plunger 440 locked in the proximal position, as shown in Fig. 6F, the axial slider 328 can be distally moved towards the slot distal end 352, as shown in Fig. 6G, which is the same handle configuration shown in Fig. 6A, ready to be re-utilized in a similar manner to that of any of the examples described herein for utilizing apparatus 300.

[0183] In some examples, the support body 338 can include a stationary magnet 356 and the axial slider 328 can include a slider magnet 332 aligned (for example, circumferentially aligned) with the stationary magnet 356. The stationary magnet 356 can be situated, in some examples, in the intermediate portion 348 of the support body 338, at or in close proximity to the axial position of the slot distal end 352. The slider magnet 332 can be situated, in some examples, close to an inner surface of the axial slider 328, oriented towards the support body 338. When the axial slider 328 is moved towards the slot distal end 352, the slider magnet 332is magnetically attracted to the stationary magnet 356, as shown in Figs. 6A and 6G, configured to axially position the axial slider 328 at the desired position relative to other components of the handle 302, such as the anvil proximal surface 336.

[0184] Proximally moving the axial slider 328 at a force that exceed the magnetic attraction between the magnets, separates between the magnets as shown in Figs. 6A-6F. However, as the axial slider 328 is distally slid, the magnetic attraction facilitates correct axial positioning of the axial slider 328, and prevents it from being spontaneously moved during manipulation of the handle 302. While magnets 332, 356 are illustrated and described as biasing means of the axial slider 328 in its distal position, it is to be understood that other biasing members can be used to bias the axial slider 328 to a desired distal position, such as, for example, springs (e.g., extension springs).

[0185] In some examples, the handle 302 further includes an adjustment knob 322 configured to adjust the axial position of the axial slide 328 when distally moved towards the slot distal end 352. The adjustment knob 322 can include an inner threading 324 that engages the outer threading 346 of the support body’s distal portion 344, such that rotation of the adjustment knob 322 results in axial translation thereof relative to the support body 338. Thus, when the adjustment knob 322 is rotated in a rotational direction which can be clockwise or counterclockwise, it can be axially moved, in the proximal or distal directions, defining the distal-most position of the axial slider 328. The axial slider 328 can be moved in the distal direction, until it abuts the proximal surface of the adjustment knob 322. Adjustment of the distal-most position of the axial slider 328 and its protrusion 330 can dictate the maximal axial translation of the plunger 440 before the head portion 444 is stopped by the protrusion 330.

[0186] Various exemplary implementations for apparatus 300 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 302aof apparatus 300a, illustrated in Figs. 6A-6G, is an exemplary implementation of handle 302, and thus can include any of the features described for handle 302 throughout the current disclosure, except that the sleeve 400aof handle 302aisconfigured to be maintained in a locked configuration merely by virtue of the distally biasing force of the biasing member 434.

[0187] Figs. 7A-8C show an exemplary handle 302b, which is similar to any example described herein for handle 302a, except that the handle 302bfurther comprises an additional safety mechanism including a lever 420 that needs to be pressed to allow retraction of the sleeve 400b. Figs. 7A-7C are perspective views of handle 302bin different states thereof. Figs. 8A-8C are cross-sectional view of a proximal portion of the handle 302bcorresponding to the respective states shown in Figs. 7A-7C. Figs. 7A-8C are described herein together.

[0188] The handle 302bcan include a lever 420 pivotably attached to the sleeve 400bat a hinge 426. In some examples, the lever 420 is hinged to the proximal end 404 of the sleeve 400b. In some examples, the lever 420 is hinged to the flange 408bof the sleeve 400b. The lever 420 includes a distal end portion 424 extending distally from the hinge 426, and a proximal end portion 428 extending proximally from the hinge 426. The proximal end portion 428 defines a lever proximal surface 430 facing the second outer step 370 of the support body 338b.

[0189] The handle 302bfurther comprises a biasing member 432 disposed distally to the hinge 426. The biasing member 432 extends between the sleeve 400band the distal end portion 424 of the lever 420, configured to pivotably bias the distal end portion 424 of the lever 420 radially outwards, away from the sleeve 400b, as shown in Figs. 7A and 8A. In some examples, the biasing member 432 comprises a coil compression spring, though the illustrated spring 432 can be replaced and / or additionally accompanied by other biasing members, such as an elastomeric body (e.g., a silicone of polyurethane component) which is compressible under external force application, and returns to its original shape when such force is removed, or any other type of biasing member configured to outwardly bias the distal end portion 424 of the lever 420. In some examples, the lever 420 further comprises a bore 422 into which the biasing member 432 can extend. In some examples, the biasing member 432 can optionally be referred to as a lever biasing member.

[0190] In some examples, the sleeve 400bfurther comprises a retainer 416 circumferentially aligned with the lever 420 and extending outwardly from the outer surface of the sleeve 400b, the retainer 416 defining an opening 418 into which at least part of the distal end portion 424 of the lever 420 extends. As shown in Figs. 7A and 8A, the retainer 416 is configured to limit the extent to which the distal end portion 424 is outwardly biased by the biasing member 432. In some examples, the outwardly biased state of the distal end portion 424 aligns the proximal end portion 428 with the second outer step 370 of the support body 338b, such that at least part of the lever proximal surface 430 is congruent with at least part of the second outer step 370.In this position, as shown in Figs. 7 A and 8 A, contact between the lever proximal surface 430 and the second outer step 370 of the support body 338bprevents the sleeve 400bfrom being proximally pulled, maintaining it in a locking configuration that keeps the locks the plunger 440 in the proximal position.

[0191] When the distal end portion 424 of the lever 420 is actively pressed against the sleeve 400b, as shown in Figs. 7B and 8B, the biasing member 432 and the proximal end portion 428 of the lever 420 is moved radially outwards, offsetting the lever proximal surface 430 radially away from the second outer step 370 of the support body 38b. In this position, the sleeve 400bcan be proximally pulled to the release configuration, as shown in Figs. 7C and 8C.

[0192] When the sleeve 400bneeds to return to the locked configuration, the proximal pull force can be release from the sleeve 400b, allowing the biasing member 434 to distally urge the sleeve 400bback to the locking configuration of Figs. 7B and 8B, and the lever 420 can be released, allowing it to pivot about the hinge 426 back to the position shown in Figs. 7A and 8A, thereby preventing spontaneous undesired proximal movement of the sleeve 400bthat can otherwise unintentionally unlock the plunger 440.

[0193] In some examples, the handle 302 further includes a sleeve stopper 382 extending radially outwards from the support body 338, positioned distal to the radial holes 358. The sleeve stopper 382, shown for example in Figs. 8A-8C, can be sized so as to allow it to extend into the first bore portion 406a of the sleeve bore 406, yet extending radially past the second bore portion 406b, to serve as a stopper against the narrowed segment 403 of the sleeve 400. Thus, when the sleeve 400 is released from the release configuration, shown for example in Fig. 8C, towards the locking configuration, shown for example in Fig. 8A, the biasing member 434 urges the sleeve in the distal direction, until the narrowed segment 403 abuts the sleeve stopper 382, arresting further distal movement of the sleeve 400.

[0194] It is to be understood that the sleeve stopper 382 is illustrated in Figs. 8A-8C as part of a handle 302bthat includes a lever 420 by way of illustration and not limitation, and that the sleeve stopper 382 can be included in any exemplary handle 302 disclosed herein, including handle 302aillustrated in Figs. 6A-6G.

[0195] In some examples, a handle 302 can further include a pre-loading adjustment mechanism, to adjust the amount of pre-loading of the biasing member 456, which will affect the impact force applied by the plunger 440 upon release. In some examples, the handle 302 comprises a preload adjustment knob 460 configured to adjust the preload of the biasing member 456, such as by controlling the compression of a biasing member 456 when the plunger 440 is locked in the proximal position. The preload adjustment knob 460 includes a proximalgrasping end portion 462 which can be proximal to the proximal portion 368 of the support body 338, and an adjustment body 464 extending distally from the proximal grasping end portion 462 through the proximal opening 372 into a proximal body bore 378 of the proximal portion 368.

[0196] The proximal body bore 378 can be continuous with the body lumen 342, yet larger in diameter than portion of the body lumen 342 extending through the remainder of the support body 338, thereby defining a body inner step 377 at the transition from the body lumen 342 to the proximal body bore 378. The proximal body bore 378 can include an inner threading 380, and the adjustment body 464 can include an outer threading 466 that engages the inner threading 380 of the proximal body bore 378.

[0197] The preload adjustment knob 460 further includes a central bore 468 axially extending therethrough, wherein the central bore 468 includes a proximal bore portion 468a and a distal bore portion 468b extending distally from, and being continuous with, the proximal portion 468a. The proximal bore portion 468a has a diameter configured to allow extension of the plunger proximal portion 452 therethrough, yet smaller than the diameter of the plunger’ s main body 445. The distal portion 468b has a diameter larger than that of the proximal portion 468a, dimensioned to allow extension of the main body 445 of the plunger 440 therethrough. An inner step 470 of the preload adjustment knob 460 is defined at the transition between the proximal portion 468a and the distal portion 468b of the central bore 468.

[0198] As shown in Figs. 8A-8C, the biasing member, for example a biasing member 456, is disposed between the outer step 454 of the plunger 440 and the inner step 470 of the preload adjustment knob 460. In use, when the plunger 440 is locked by the sleeve 400 in the proximal position, rotation of the preload adjustment knob 460 in a clockwise or counterclockwise direction can axially move it, along with its inner step 470, closer to or farther from the outer step 454 of the plunger 440, thereby adjusting the compression of the biasing member 456. For example, approximating the inner step 470 of the preload adjustment knob 460 to the outer step 454 of the plunger 440 will increase the compression of the biasing member 456, thereby increasing the impact force imparted by the plunger 440 on the anvil 334 when the sleeve 400 is proximally pulled to release the plunger 440. The axial length of the proximal body bore 378 can be designed to define a maximal allowed preload, such that distal advancement of the adjustment body 464 is arrested when it reaches the body inner step 377.

[0199] It is to be understood that the preload adjustment mechanism, including preload adjustment knob 460, is illustrated in Figs. 8A-8C as part of a handle 302bthat includes a lever 420 by way of illustration and not limitation, and that the same mechanism, including preloadadjustment knob 460, can be implemented in any exemplary handle 302 disclosed herein, including handle 302aillustrated in Figs. 6A-6G.

[0200] Fig. 9 illustrates an exemplary tissue perforation apparatus 500 that includes a hollow needle 210 and an anchor device 230 coupled to and extending distally from a handle 502. Fig. 10 is a cross-sectional side view of the handle 502. Figs. 11 and 12 are enlarged perspective views of an anvil 550 and a hammer 570 of the handle 502. Fig. 13 is a cross-sectional view taken along line 13-13 of Fig. 10. Figs. 9-13 are described herein together. The terms “tissue perforation apparatus 500” and “apparatus 500”, as used herein, are interchangeable.

[0201] The needle 210 of apparatus 500 can be the same as any example described herein for needle 210 used in an apparatus 300. Apparatus 500 further comprises an anchor device 230 disposed around the needle 210, wherein the anchor device 230 includes a helical anchor head 232 that can be anchored into the target tissue, such as a host leaflet 10, so as to capture and stabilize the host leaflet 10 during formation of a pilot puncture by the needle 210.

[0202] In some examples, the tissue perforation apparatus 500 can include a delivery catheter 250 attached to a handle 502 and extending distally therefrom. The delivery catheter 250 defines a delivery catheter lumen 252 (indicated, for example, in Fig. 16B) and can have a delivery catheter distal end portion 254 which can include, in some examples, an atraumatic distal end 256, such as by being rounded and / or being curved radially inwards, or otherwise formed to include an outer surface tapering in the distal direction.

[0203] The anchor device 230 of apparatus 500 includes a helical anchor head 232 which is attached, directly or via one or more intermediate components, to an anchor shaft 240. The helical anchor head 232 defines an anchor channel 234 and has a sharp anchor tip 236 configured to allow it to engage and penetrate a target tissue, such as a host leaflet 10 of a host valvular structure. The anchor head 232 can be used in combination with the needle 210 which can extend through the anchor channel 234 towards and through a host leaflet 10, for modifying the host leaflet 10. The anchor shaft 240 can extend through the delivery catheter lumen 252. The terms “helical anchor head 232” and “anchor head 232”, as used herein, are interchangeable.

[0204] The anchor shaft 240 can be a torque shaft, configured to be rotatable relative to another shaft of the apparatus 500, such as relative to the delivery catheter 250 and / or the needle shaft 220. The anchor head 232 is affixed, directly or via one or more intermediate components, to a distal end portion 244 of the anchor shaft 240, such that rotation of the anchor shaft 240 effects rotation of the anchor head 232 therewith. The anchor shaft 240 defines a lumen 242 which is in fluid communication with the anchor channel 234. In some examples, at least aportion of the anchor shaft 240 is formed as a hypotube, configured to increase flexibility thereof. In some examples, at least a portion of the anchor shaft 240 comprises a helical hollow strand (HHS) tube.

[0205] The helical anchor head 232 can define one or more helical turns 238 continuously extending between along the anchor head 232 towards the anchor tip 236. In some examples, a helical anchor head 232 can be a tube-cut anchor. Manufacturing of a tube-cut anchor head 232 can employ any suitable cutting method, such as, but not limited to, laser cutting, waterjet cutting, plasma cutting, and the like. In some examples, the helical anchor head 232 can be formed from a rounded wire shaped to form the helical turns 238 of the anchor head 232. Sharpening the anchor tip 236 can employ grinding or any other suitable sharpening method.

[0206] The proximal ends of the delivery catheter 250, the anchor shaft 240 and the needle shaft 220 extend into and are coupled to the handle 502 of apparatus 500. During delivery through the patient's vasculature, the handle 502 can be maneuvered by an operator (for example, a clinician or a surgeon) to control movement of components of the apparatus 500, such as the anchor shaft 240 and the needle shaft 220.

[0207] The delivery catheter 250 comprises a delivery catheter proximal end portion 258 which is affixed to the handle 502. In some examples, the delivery catheter proximal end portion 258 is affixed to a housing 590 of the handle 502. The housing 590 can include a distal housing portion 590a and a proximal housing portion 590b. In some examples, the delivery catheter 250 extends through an axial channel 504 of the handle 502. The axial channel 504 can be defined by the distal housing portion 590a of the handle 502. In some examples, the delivery catheter 250 extends through the axial channel 504. In some examples, the delivery catheter proximal end portion 258 is affixed to the axial channel 504. The delivery catheter proximal end portion 258 can be rigidly coupled to a component of the handle 502, such as a section of the distal housing portion 590a surrounding the axial channel 504, using any suitable method, such as gluing, welding, clamping, threads, and the like.

[0208] The anchor shaft 240 extends through the delivery catheter lumen 252 into the handle 502. In some examples, the anchor shaft 240 extends proximally from the delivery catheter 250, such as proximally from the delivery catheter proximal end portion 258, and comprises an anchor shaft proximal portion 246 coupled to a mechanism configured to facilitate rotational movement of the anchor device 230. The handle 502 comprises an anchor control knob 512 configured to control rotational movement of the anchor shaft 240.

[0209] The needle shaft 220 extends through the anchor shaft lumen 242 into the handle 502. In some examples, the needle shaft 220 extends proximally from the anchor shaft 240, such asproximally from the anchor shaft proximal portion 246, and comprises a needle shaft proximal end portion 228 coupled to the handle 502. The handle 502 comprises a needle advancement knob 534 configured to control axial movement of the needle 210.

[0210] In some cases, it may be desired to impart rotational impact upon the anchor device 230 to drive the anchor head 232 into the target tissue, such as a host leaflet, in a relatively stable and accurate manner. The handle 502 includes a rotational impact mechanism controllable by the anchor control knob 512. In some examples, the handle 502 includes a hammer 570 and an anvil 550. The anvil 550 defines an anvil lumen 556 through which the anchor shaft 240. In some examples, the anchor shaft proximal portion 246 extends into the anvil lumen 556 and is rigidly secured to the anvil 550, such that rotational and / or axial movement of the anvil 550 moves the anchor device 230 in the same direction therewith.

[0211] The anvil 550 includes anvil lugs 558 extending radially outwards relative to the anvil lumen 556. The anvil can further include, in some examples, an anvil distal portion 552 extending distally from the position of anvil lugs 558, and an anvil proximal portion 554 extending proximally from the position of the anvil lugs 558. As further shown in Fig. 11, for example, each anvil lug 558 defines an angled side surface 560, a flat side surface 562 opposite to the angled side surface 560, and a proximal lug surface 564 extending between the side surfaces 560 and 562. While two anvil lugs 558 are illustrated in Fig. 11, it is to be understood that any other number of anvil lugs 558 is contemplated, including a single anvil lug 558 or more than two anvil lugs 558.

[0212] The hammer 570 can include a hammer distal portion 572 and a hammer proximal portion 576. As further shown in Fig. 12, for example, the hammer distal portion 572 can include distally extending hammer lugs 574. The hammer proximal portion 576 can include a hammer gear 578 equipped with outer gear teeth 580. While two hammer lugs 574 are illustrated in Fig. 12, it is to be understood that any other number of hammer lugs 574 is contemplated, including a single hammer lug 574 or more than two hammer lugs 574. The number of hammer lugs 574 can match, in some examples, the number of anvil lugs 558.

[0213] The hammer 570 further defines a hammer bore 582, through which the anvil proximal portion 554 can extend. The hammer bore 582 can include a distal bore portion 582a and a proximal bore portion 582b having a diameter that is larger than that of the distal bore portion 582a, thereby defining a hammer inner step 584 at the transition between the distal bore portion 582a and the proximal bore portion 582b.

[0214] The handle 502 further comprises a support body 526 comprising a central bore 530. The central bore 530 can have several bore portions continuous with each other. In someexamples, the central bore 530 can include a first bore portion 530a (for example, see Fig. 10), a second bore portion 530b extending proximally from the first bore portion 530a and having a smaller diameter than the first bore portion 530a, a third bore portion 530c extending proximally from the second bore portion 530b and having a larger diameter than the second bore portion 530b, and a fourth bore portion 530d extending proximally from the third bore portion 530c and having a smaller diameter than the third bore portion 530c. A support surface 532 can be defined at the transition between the first bore portion 530a and the second bore portion 530b. The support surface 532 is positioned proximal to, and facing, the hammer inner step 584.

[0215] A biasing member 586 can be at least partially disposed inside the first bore portion 530a of the central bore 530, optionally around at least part of the anvil proximal portion 554. The biasing member 586 extends between the support surface 532 and the hammer inner step 584, configured to distally bias the hammer 570, along with the hammer lugs 574, towards the anvil lugs 558. In some examples, the biasing member 586 comprises a coil compression spring, though the illustrated spring 586 can be replaced and / or additionally accompanied by other biasing members, such as an elastomeric body (e.g., a silicone of polyurethane component) which is compressible under external force application, and returns to its original shape when such force is removed, or any other type of biasing member configured to distally bias the hammer 570. In some examples, the biasing member 586 can be optionally referred to as a hammer biasing member.

[0216] As mentioned, the hammer 570 can include a hammer gear 578 with outer gear teeth 580 disposed around the circumference of the hammer proximal portion 576. The hammer gear 578 can be integrally formed with the hammer proximal portion 576, or it can be provided as a separate gear that can be disposed around, and rigidly attached to, the hammer proximal portion 576.

[0217] In some examples, the anchor control knob 512 can include inner gear teeth 514. The inner gear teeth 514 can be integrally formed with the anchor control knob 512, as illustrated for example in Fig. 13, or they can be inner teeth of a separate inner gear that can be disposed inside, and attached to an inner surface of, the anchor control knob 512. In some examples, the handle 502 can further include idler gears 516 axially aligned with the hammer gear 578.

[0218] As further illustrated in Fig. 13, the inner gear teeth 514 of the anchor control knob 512 are meshed with the outer gear teeth 520 of the idler gears 516. The outer gear teeth 520 of the idler gears 516 are in turn meshed with the outer gear teeth 580 of the hammer gear 578. Eachof the idler gears 516 can comprise a central bore 518 through which extends a support shaft 524 around which the idler gear 516 can rotate.

[0219] In use, when the anchor control knob 512 is rotated, such as by a user of the handle 502, it rotates the idler gears 516 which are meshed therewith, which in turn rotate the hammer 570. The number of meshed gear teeth and the size and number of idler gears 516 can be selected according to any desired transmission ratio between the anchor control knob 512 and the hammer 570. While two idler gears 516 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 512 to the hammer 570. In some examples, the idler gears 516 may be omitted and the hammer gear 578 can be designed to directly contact and mesh with the inner gear teeth 514 of the anchor control knob 512, which will result in a 1: 1 transmission ratio.

[0220] The support shafts 524 extending through the idler gears 516 can distally extend, through axial bores 528 formed in the support body 526, from a plate 522 disposed between the support body 526 and the needle advancement knob 534. The plate can define a central opening (no annotated) aligned with the fourth bore portion 530d of the central bore 530, through which the needle shaft 220 can extend.

[0221] Figs. 14A-14D show the rotational impact mechanism of handle 502 in use, with components of the handle 502, such as the housing 590, anchor control knob 512, and idler gears 516, removed for the sake of clarity. The various components illustrated in Figs. 14A- 14D are not necessarily in scale, and relative positions between some components may be adjusted for illustrative purposes. For example, the support body 526 is schematically illustrated in Figs. 14A-14D, and distanced farther from the hammer 570 relative to the positions shown in Fig. 10, to expose a larger portion of the biasing member 586.

[0222] In the state shown in Fig. 14A, the hammer 570 is distally urged by the biasing member 586, with the hammer lugs 574 disposed between, and optionally next to, the anvil lugs 558. As the hammer 570 is rotated in a rotational direction 90, for example by rotating the anchor control knob 512 as described above, the hammer lugs 574 engage with, and slide along the angled side surfaces 560 of, the anvil lugs 558, as shown in Fig. 14B. as the hammer is rotated, as shown in Figs. 14B and 14C, rotational movement from the hammer lugs 574 is also transmitted to the anvil lugs 558, causing the anvil 550 and the anchor device 230 affixed thereto, to rotate in direction 90 as well.

[0223] As further shown in Fig. 14C, continued rotation causes the hammer 570 to move proximally, compressing the biasing member 586 against the support surface 532, as the hammer lugs 574 slide along the anvil lugs 558. Accordingly, potential energy is stored in thebiasing member 586 until the hammer lugs 574 reach the proximal lug surfaces 564, slide along the proximal lug surfaces 564, reaching a released position shown in Fig. 14D, in which the biasing member 586 is allowed to forcibly push the hammer 570 in the distal direction, such that the hammer 570 strikes against the anvil, for example by a distal surface of the hammer distal portion 572 forcibly impacted against the proximal lug surfaces 564. Continued rotation of the hammer 570 will rotate the hammer lugs 574 between the anvil lugs 558 until the hammer lugs 574 contact the anvil lugs 558 one more, repeating another cycle of rotational impact force transmitted to the anchor device 230 in the same manner to that described above with respect to Figs. 14A-14D.

[0224] In some examples, the handle 502 can further include an anvil support portion 506, optionally defined by the distal housing portion 590a or disposed inside the distal housing portion 590a, through which the anvil proximal portion can extend. The anvil support portion 506 can provide support to the elongated proximal portion 554 of the anvil 550. In some examples, the handle 502 further comprises a radial thrust bearing 566 disposed around the anvil 550, For example, a radial thrust bearing 566 can be disposed between the anvil support portion 506 and the anvil proximal portion 554. The radial thrust bearing 566 can allow the anvil 550 to rotate relative to the housing 590 and / or relative to the anvil support portion 506.

[0225] In some examples, the handle 502 further comprises an axial thrust bearing 588 positioned between the biasing member 586 and the hammer 570. In some examples, the axial thrust bearing 588 can be positioned between the biasing member 586 and the hammer inner step 584. The axial thrust bearing 588 can allow the biasing member 586 to continue to rotate relative to the hammer 570 after each impact strike when the hammer lugs 574 engage with the anvil lugs 558 and rotation of the hammer 570 momentarily stops.

[0226] The handle 502 can optionally further include a needle displacement mechanism controlled by needle advancement knob 534 to displace the needle 210 relative to the handle 502 and / or relative to the anchor device 230. In some examples, the handle 502 can include a lead member 536 that can be received within the proximal housing portion 590b. A distal end portion of the lead member 536 can protrude from a distal end of the proximal housing portion 590b. In some examples, the needle advancement knob 534 can be attached to or integrally formed with the distal end portion of the lead member 536 such that rotation of the needle advancement knob 534 results in rotation of the lead member 536.

[0227] The lead member 536 includes a lead bore 537 with an inner threading 538. An axial guide member 568 can be optionally disposed within the lead bore 537 and can optionally be coaxial with the lead bore 537. The axial guide member 568 is axially and rotationally fixedrelative to the proximal housing portion 590b, which means that the axial guide member 568 does not rotate when the lead member 536 is rotated. The axial guide member 568 can define an inner bore defining two guide slots 569 that extend radially outward, toward the inner threading 538, in opposite directions. The guide slots 569 extend axially along the length of the axial guide member 568.

[0228] The handle 502 can optionally further include a carriage 540 having a carriage head 542 disposed within the bore 537 of the lead member 536. In some examples, the carriage 540 can optionally further comprise a rear port 546 extending proximally from the head portion 542. The head portion 542 can optionally include a main body 543 and two radial projections 545 extending radially outward from the main body 543 in opposite directions and toward the inner threading 538 of the lead member 536. Optionally, the main body 543 can be formed and dimensioned to be situated within the bore extending through the axial guide member 568, while the guide slots 569 can be dimensioned to accommodate the respective radial projections 564.

[0229] The outer surface of the radial projection 564 comprises outer threading 544 that engages the inner threading 538 through the guide slots 569. Thus, rotation of the lead member 536 by rotating the needle advancement knob 534 results in translation of the carriage 540 along the axial guide member 568. The axial guide member 568ensures that the translation of the carriage 540 will occur only along the axial direction of the handle 502, preventing rotational movement of the carriage 540.

[0230] The carriage 540 defines a carriage bore 548 into which a proximal end portion 228 of the needle shaft 220 extends. The needle shaft proximal end portion 228 is rigidly attached to the carriage 540 using any suitable method, such as gluing, welding, clamping, threads, and the like. The rigid connection between the needle shaft proximal end portion 228 and the carriage 540 will allow the needle shaft 220 to move axially as the carriage 540 moves axially in response to rotation of the needle advancement knob 534 and the lead member 536.

[0231] The length of the lead bore 537, the length of the axial guide member 568, and / or the length of the head portion 542 of carriage 540 can be selected to provide the desired axial translation range of the needle shaft 220. The number and spacing of the threads in the inner threading 538 and the mating threads in the outer threading 544 can be selected to provide the desired proportion between the number of needle advancement knob 534 rotations and the extent of axial translation of the needle shaft 220.

[0232] In use, rotation of the needle advancement knob 534 in a first direction can advance the needle shaft 220 distally, and rotation of the needle advancement knob 534 in a second direction that is opposite to the first direction can retract the needle shaft 220 proximally.

[0233] In some examples, a proximal wall 508 of the proximal housing portion 590b can optionally include a rear opening 510 through which the rear port 546 of the carriage 540 can extend. The rear port 546 can optionally be, in some examples, partially exposed through the rear opening 510 of the proximal housing portion 590b. The carriage bore 548 can optionally be exposed at the proximal end of the rear port 546, through which a portion of a guidewire can extend, into (or out of) the needle lumen 212.

[0234] In some examples, the tissue perforation apparatus 500 can be used as part of a stabilized tissue modification system 600. Fig. 15 shows an exemplary stabilized tissue modification system 600, which can include a steerable delivery apparatus 602. A steerable delivery apparatus 602 can include an outer catheter 610, optionally implemented as a steerable catheter. The steerable outer catheter 610 can be advanced towards the valvular structure 12 over a guidewire 80, and the delivery catheter 250 can be passed, along with the anchor device 230 and needle 210, through the outer catheter 610, over a guidewire 80, towards the host leaflet 10.

[0235] In some examples, 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 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 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 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 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.

[0236] 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 500, taking advantage of the steerability of the outer catheter 610 to navigate it during delivery, afterwhich the delivery catheter 250 can be inserted through a rear port 608 of the handle 604 and advanced through the outer catheter 610.

[0237] Figs. 16A-16F illustrate some steps in a method for utilizing a tissue perforation apparatus 500, 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. 16A-16F, as well as follow up steps for forming a tissue opening illustrated in Figs. 18A-18E, with respect to forming a leaflet opening inside a host leaflet, which can be performed prior to implanting a guest prosthetic valve inside the host valvular structure, as further described below with respect to Figs. 18F-18G for example. The apparatus 500 can be used to perforate a host leaflet 10, such as a native leaflet 30 or a prosthetic valve leaflet 114 of a previously implanted prosthetic valve.

[0238] The distal end portion of the apparatus 500, which can include the atraumatic distal end portion 254 of the delivery catheter 250, 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 250 toward the leaflet over a guidewire 80. The needle 210 can be configured to accommodate a guide wire 80 that can extend through the needle lumen 212.

[0239] During delivery, the anchor head 232 can be retained inside delivery catheter lumen 252, such that the anchor tip 236 is at or proximal to the delivery catheter distal end portion 254, as illustrated in Fig. 16A. This position conceals the sharp tip 236 of the anchor head 232 from the surrounding anatomy, to protect the anatomical structures, as well as the outer catheter 610 through which it can be advanced, from being engaged or punctured by the anchor tip 236 during advancement towards the site of treatment. The needle head 214 can be similarly retained inside the anchor device 230, such that the needle tip 218 is at or proximal to the anchor tip 236. This position conceals the sharp tip 218 of the needle head 214 from the surrounding anatomy and / or outer catheter 610, to similarly protect them from being engaged or punctured by the sharp needle tip 218 during advancement towards the site of treatment.

[0240] The anchor head 232 can be approximated to the host leaflet 10, and the anchor control knob 512 can be then rotated in a rotational direction that imparts rotational impact force to the anchor head 232, causing the anchor head 232 to engage and penetrate the host leaflet 10, thereby securing the anchor head 232 to host leaflet 10 as shown in Fig. 16B. The tissue material of host leaflet 10 can be retained between successive helical turns 238 of the anchor head 232. In some examples, the delivery catheter distal end 254 can be in contact with, and / or slightly pushed against, the host leaflet 10, prior to applying rotational impact force to theanchor head 232 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 230 and needle 210 advancement, which can increase stability of the leaflet for improved engagement with the anchor head 232 at it is being impact-driven thereinto.

[0241] Following engagement of the anchor head 232 with the host leaflet 10, the needle 210 should be advanced to puncture the tissue material. For that end, the needle advancement knob 534 can be rotated in a rotational direction that facilitates distal advancement of the needle 210, causing the needle head 214 to puncture the host leaflet 10 to form a pilot puncture 50 within host leaflet 10, as shown in Fig. 16C.

[0242] An attempt to pass a needle 210 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 232 captures the host leaflet 10 and stabilizes it during formation of a pilot puncture 50 by a needle 210 being pushed against and through the host leaflet 10.

[0243] Once the needle head 214 is positioned, at least partially, past the host leaflet 10, the guidewire 80 can be advanced through the needle lumen 212 to terminate with guidewire tip 82 at a position distal to the pilot puncture 50 of host leaflet 10 as shown in Fig. 16D.

[0244] Subsequent to forming the pilot puncture 50 and optionally advancing the guidewire 80 to extend therethrough, the needle 210 can be optionally retracted, as shown in Fig. 16E, by rotating the needle advancement knob 534 in a counter rotational direction configured to facilitate proximal movement of the needle shaft 220.

[0245] The anchor control knob 512 can be then 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 232 from the host leaflet 10, which can be similarly retracted by being then axially pulled away from the host leaflet 10, as shown in Fig. 16F, while leaving the guidewire 80 extending through the pilot puncture 50. Counter-rotation of the anchor control knob 512, which results in rotation of the hammer 570 in a direction opposite to direction 90 shown in Figs. 14A-14B for example, will press the hammer lugs 574 against the flat side surfaces 562 of the anvil lugs 558, thus rotating the anvil along with the anchor device 230 in the same direction, without causing axial sliding movement of the hammer 570 along the anvil 550. Thus, release of the anchor head 232 can be achieved by pure rotational movement of the anchor head 232 in a release direction, without applying any impaction forces.

[0246] It is to be understood that the order of procedural steps described above with respect to Figs. 16D-16F is merely shown for illustrative purpose, and that in some examples, reverse rotation of the helical anchor head 232 to release it from the host leaflet 10 and retract it can be performed prior to needle 210 retraction. In some examples, counter-rotation of the anchor control knob 512 to release the anchor head 232 from the host leaflet 10 can be performed prior to counter rotation of the needle advancement knob 534 to retract the needle 210, and axial retraction of the anchor head 232 can be performed simultaneously with, or subsequent to, needle 210 retraction.

[0247] In some examples, the guidewire 80 can be advanced simultaneously with advancement of the needle 210 during formation of the pilot puncture 50. In some examples, the guidewire 80 can be advanced to terminate distal to the host leaflet 10 after formation of the pilot puncture 50 by the needle 210, as illustrated in Fig. 16D. In some examples, the guidewire 80 can be advanced through pilot puncture 50 to terminate distal to the host leaflet 10 after retrieval of the needle 210, optionally prior to release of the anchor head 232 from the host leaflet 10.

[0248] In some examples, advancement of the guidewire 80 to position the guidewire tip 82 distal to the pilot puncture 50 can be performed subsequent to counter-rotation of the anchor control knob 512 to release the anchor head 232 from the host leaflet 10 and / or axial retraction of the anchor head 232, while the needle 210 is still positioned inside of pilot puncture 50, after which the needle 210 can be retracted. In some examples, advancement of the guidewire 80 to position the guide wire tip 82 distal to the pilot puncture 50 can be performed after needle 210 retraction while the anchor head 232 is still engaged with the host leaflet 10, after which the anchor head 232 can be released and retracted.

[0249] In some examples, a stabilized tissue modification system 600 can further include a dilation apparatus 620, having a hole-dilating balloon 638 mounted on a balloon catheter 632, as shown in Fig. 17 for example. After formation of the pilot puncture 50, the apparatus 500 can be retrieved from the patient's body, optionally by retraction through the outer catheter 610 and out of the handle 604 of steerable delivery apparatus 602, while leaving the outer catheter 610 in position and the guidewire 80 extending through the pilot puncture 50.

[0250] Thereafter, the balloon catheter 632 of dilation apparatus 620 can be inserted into the delivery catheter 250 through the rear port 608 of the handle 604, through the handle 604 and the outer catheter 610, as shown in Fig. 17. The balloon catheter 632 can be then advanced through the outer catheter 610, optionally over the guidewire 80, towards the host leaflet 10, as shown for example in Fig. 18A.

[0251] The hole-dilating balloon 638 is configured to transition between a radially deflated state, shown for example in Figs. 18A-18C, and a radially inflated state, shown for example in Fig. 18D. The hole-dilating 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. 18D and explained in greater detail below.

[0252] An enlarged view of a distal portion of the dilation apparatus 620 is illustrated in Fig. 17, extending out of the outer catheter 610 for example. Cross-sectional views of the distal portion of the dilation apparatus 620 are further shown throughout Figs. 18 A- 18E. 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 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.

[0253] The second adaptor port 644b can be fluidly connectable to a fluid source (not shown) for inflating the hole-dilating 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 hole-dilating 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 hole-dilating balloon 638 to inflate it.

[0254] In some examples, an inflatable balloon 638 of apparatus 620, utilized as a hole-dilating balloon, can be different from a typical balloon used for expanding balloon-expandable prosthetic valves or stents, in that while a typical valve-expanding balloon is inflatable to a diameter that can allow expansion of a prosthetic valve to a functional diameter thereof, which can be similar to, or greater than (for example, in the case of valve over-expansion) the diameter of the native annulus in which the valve is deployed, the maximum diameter of a hole-dilating balloon 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 hole-dilating balloon 638).

[0255] In some examples, such as when dilation of a pilot puncture 50 is desired to form a larger leaflet opening 52, without necessarily tearing the leaflet 10, the maximum diameter to which the hole-dilating balloon 638 can be inflated is equal to or less than 12 mm. In some examples, the maximum diameter to which the hole-dilating balloon 638 can be inflated is equal to or less than 10 mm. Nevertheless, as mentioned above, in some examples a hole-dilating balloon 638 can be configured to tear a host leaflet 10, in which case the maximum diameter to which the hole-dilating balloon 638 can be inflated can be greater than 12 mm., such as in a range of 20-25 mm.

[0256] In some examples, 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 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 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.

[0257] In some examples, the hole-dilating 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 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. 17-18E, the hole-dilating 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 hole-dilating balloon 638, such that the outer surface of the hole-dilating balloon 638 can be flush or otherwise relatively continuous with the outer surface of the dilator 622.

[0258] In some examples, such as when the hole-dilating 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 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.

[0259] The dilator shaft 640 can 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 inflationopenings 636 exposed to an internal cavity of the hole-dilating balloon 638, which can 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 inject inflation fluid (for example, saline) into the hole-dilating 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. 18D. The pressure of the inflation fluid within hole-dilating 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.

[0260] Figs. 18A-18E illustrate some steps in a 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 tissue perforation apparatus 500, the hole-dilating balloon 638, carried over the balloon catheter 632, can be advanced towards the host leaflet 10 according to any of the methods described above.

[0261] In some examples, when the dilation apparatus 620 further includes a dilator 622 as also shown in the example illustrated in Fig. 18A, the dilator 622 can be advanced, optionally along with the balloon catheter 632 and hole-dilating balloon 638, towards the host leaflet 10. When included in dilation apparatus 620, the dilator 622 can be inserted into the pilot puncture 50 to expand the pilot puncture 50, as shown in Fig. 18B. 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 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.

[0262] In a subsequent step of the method, illustrated in Fig. 18C, the hole-dilating 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 hole-dilating balloon 638 received within the pilot puncture 50, inflating the hole-dilating balloon 638 to transition it from a radially deflated state (Fig. 18C) to a radially inflated state (Fig. 18D) can expand the pilot puncture 50 to form a leaflet opening 52 that is sized to receive the prosthetic valve 100 in the radially compressed or crimped configuration. After the hole-dilating balloon 638 is inflated to form the leaflet opening 52 as shown in Fig. 18D, the hole-dilating balloon 638 is deflated, as shown in Fig. 18E, optionally allowing for insertion of a guest prosthetic valve inside the leaflet opening 52.

[0263] In some examples, inflating the hole-dilating 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.

[0264] In some examples, inflating the hole-dilating 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).

[0265] While a dilation apparatus 620 that includes a hole-dilating 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 be used as an expansion member instead of a valve-expanding balloon.

[0266] In some examples, retraction of the hole-dilating balloon 638, after deflation thereof, can be performed while the guidewire 80 may be kept in position, extending through the leaflet opening 52. Subsequent to deflation of the hole-dilating balloon 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 further include steps of positioning a guest prosthetic valve 100 inside the leaflet opening 52. A replacement valve delivery apparatus 650 carrying the guest prosthetic valve 100 can be either part of the system 600, or provided as a separate assembly of apparatus 650 advanced into a leaflet opening 52.

[0267] Fig. 18F shows a guest prosthetic valve 100 positioned, in a radially compressed configuration thereof, inside the leaflet opening 52. As shown in Fig. 18F, the guest prosthetic valve 100 can be mounted on a replacement valve delivery apparatus 650 that can be advanced towards the host leaflet 10 over a guidewire, which can be a separate guidewire (not shown), or can be the same guidewire 80.

[0268] In some examples, the guest prosthetic valve is a balloon expandable valve, and the replacement valve delivery apparatus 650 comprises a balloon catheter 652 carrying a valveexpanding balloon 654. In contrast to some examples of a hole-dilating balloon 638 described above, such as a hole-dilating balloon 638 configured to form a leaflet opening 52 without tearing the host leaflet, the maximum diameter to which a valve-expanding balloon 654 can be inflated can be, in some examples, greater than 18 mm., greater than 20 mm., greater than 23 mm., greater than 26 mm., and / or greater than 29 mm.

[0269] While a replacement valve delivery apparatus 650 equipped with a valve-expanding balloon 654 at a distal end portion of a balloon catheter 652 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 650 can include other shafts and / or mechanisms, for example when utilized to advance and expand other types of replacement prosthetic valves, such as self-expandable prosthetic valves or mechanically expandable prosthetic valves.

[0270] In some examples, the replacement valve delivery apparatus 650 can further include a nosecone 656 positioned distal to the valve-expanding balloon 654 (or other prosthetic-valve expanding mechanism). The nosecone 656 can be conical or frustoconical in shape. The nosecone 656 can be attached to a distal end of a nosecone shaft 658 extending through the balloon catheter 652, wherein the nosecone 656 and the nosecone shaft 658 can collectively define a lumen through which a guidewire can extend. In some examples, when a nosecone 656 is present at a distal end of the replacement valve delivery apparatus 650 as also shown in the example illustrated in Fig. 18F, the nosecone 656 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 656 is inserted into the leaflet opening 52 it can optionally further expand the leaflet opening 52 to a greater diameter.

[0271] As shown in Fig. 18F, the guest prosthetic valve 100 is placed in the leaflet opening 52 in its radially compressed configuration, optionally positioned over a deflated valve-expanding balloon 654 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. 18G, 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 expandingthe 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.

[0272] In some examples, the guest prosthetic valve can be a mechanically-expandable prosthetic valve and radial expansion thereof can be achieved by actuating a mechanical actuator of the guest prosthetic valve to mechanically expand a frame of the guest prosthetic valve. In some examples, the guest prosthetic valve can be a self-expandable prosthetic valve that can be retained during delivery toward the host valvular structure in a capsule or other restraint disposed therearound, and valve expansion can be achieved by removing the capsule or other restraint from the guest prosthetic valve to allow it to radially self-expand within the host valvular structure.

[0273] Figs. 19A-20B illustrate a sequence of events in which a host valvular structure 12 is modified to receive a guest prosthetic valve 100. Figs. 19A-19B illustrate the hole-dilating balloon 638 utilized to expand the pilot puncture 50 into the leaflet opening 52. In particular, Fig. 19A illustrates the hole-dilating balloon 638 in a deflated state within the pilot puncture 50, corresponding to the state described above with respect to Fig. 18C, while Fig. 19B illustrates the hole-dilating 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. 18D. Fig. 19C illustrates a guest prosthetic valve 100 that can be positioned in the leaflet opening 52 after removal of the hole-dilating balloon 638 therefrom, in a crimped configuration of the prosthetic valve 100, corresponding to the state described above with respect to Fig. 18F, after which the guest prosthetic valve 100 can be expanded, such as by inflating a valveexpanding balloon 654 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.

[0274] As mentioned, any system, apparatus and method of the current specification can be utilized for forming a leaflet opening 52 in a host leaflet 10 which can be either a native leaflet 30 or a prosthetic valve leaflet 114 of a previously implanted prosthetic valve, such as prosthetic valve 100a of Fig. 3, such as in the case of ViV procedures. Fig. 20A shows a previously implanted prosthetic valve 100a subsequent to forming the leaflet opening 52. Fig. 20B 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. 20B, 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 suitablevalvular 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.

[0275] In the example of Fig. 20A, 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.

[0276] As shown in Fig. 20B, however, fully expanding the guest prosthetic valve 100b within the leaflet opening 52 further expands and / or tears the leaflet opening 52 such that several cell openings 112a of the frame 102a of the host prosthetic valve 100a and several cell openings 112b of the frame 102b of the guest prosthetic valve 100b are fully uncovered by the leaflets 114a. In some examples, this may result from the frame 102b of the guest prosthetic valve 100b pushing the leaflet 114a comprising the leaflet opening 52 downwardly (toward the inflow ends of the prosthetic valves 100a, 100b) such that one or more cell openings 112a are unobstructed by the leaflet 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.

[0277] While a tissue perforation apparatus 500 is described herein in 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 500 can be advanced, it is to be understood that tissue perforation apparatus 500 disclosed herein can be used in isolation, and without a separate steerable delivery apparatus 602.

[0278] While a tissue perforation apparatus 500 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 hole-dilating balloon 638, used to form a tissue opening (e.g., leaflet opening 52) after retraction of the tissue perforation apparatus 500 from a pilot puncture 50 formed thereby, it is to be understood that a tissue perforation apparatus 500 disclosed herein can be used in isolation, and without a separate dilation apparatus 620. In some examples, any exemplary tissue perforation apparatus 300 or 500 disclosed herein can further include an expansion member, such as a hole-dilating balloon 638 mounted on a balloon catheter 632, as part of the tissue perforation apparatus 500 itself.

[0279] While a tissue perforation apparatus 500 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 300or 500 disclosed herein can be used to form a puncture or opening in any target tissue, including, but not limited to, a leaflet, in any other procedure that may not require utilization of an expansion member, such as a hole-dilating balloon 638, to further expand the opening, and may not involve procedural steps of guest prosthetic valve implantation.

[0280] While an anchor device 230 is disclosed herein as part of a tissue perforation apparatus 500, it is to be understood that any exemplary tissue perforation apparatus 300 disclosed herein can include an anchor device 230 through which the needle 210 can extend.

[0281] While a delivery catheter 250 is disclosed herein as part of a tissue perforation apparatus 500, it is to be understood that any exemplary tissue perforation apparatus 300 disclosed herein can include a delivery catheter 250 that can be attached to, and extend distally from, the handle 302.

[0282] While stages of an exemplary method are described herein for forming a tissue opening in a target tissue, such as a leaflet opening 52 in a host leaflet 10, by utilizing a tissue perforation system 500, it is to be understood that any exemplary tissue perforation apparatus 300 disclosed herein, which can either further include an anchor device 230 or be used without an anchor device, can be similarly utilized to form an opening in a target tissue, following similar stages, mutatis mutandis.

[0283] While a tissue perforation apparatus 500 is described herein as an optional part of a stabilized tissue modification system 600, it is to be understood that any exemplary tissue perforation apparatus 300 disclosed herein can be similarly used as part of a stabilized tissue modification system 600, mutatis mutandis.

[0284] Any of the systems, devices, apparatus, etc. disclosed herein can be sterilized (for example, with heat, radiation, and / or chemicals, etc.) to ensure they are safe for use with patients, and any of the methods herein can include sterilization of the associated assembly, device, apparatus, etc. as one of the steps of the method. Examples of radiation for use in sterilization include, without limitation, gamma radiation and ultra-violet radiation. Examples of chemicals for use in sterilization include, without limitation, ethylene oxide and hydrogen peroxide.Some Examples of the Disclosed Technology

[0285] Some examples of above-described technology are enumerated below. It should be noted that one feature of an example in isolation or more than one feature of the example taken in combination and, optionally, in combination with one or more features of one or more examples below are examples also falling within the disclosure of this application.

[0286] Example 1. A tissue perforation apparatus comprising: a handle comprising: an anvil defining an anvil proximal surface; a plunger proximal to the anvil; a sleeve configured to move between a locking configuration, in which the plunger is axially immovable relative to the sleeve, and a release configuration, in which the anvil is allowed to axially move relative to the sleeve; and a plunger biasing member configured to distally bias the plunger; and a needle coupled to the anvil and extending therefrom; wherein, when the plunger is positioned in a proximal position thereof, and the plunger biasing member is in a loaded state against the plunger, moving the sleeve from the locking configuration to the release configuration allows the plunger biasing member to distally urge the plunger towards the anvil.

[0287] Example 2. The apparatus of any example herein, particularly of example 1, wherein, when the plunger is distally urged by the plunger biasing member towards the anvil, it strikes against the anvil at an impact force that results in distal movement of the anvil and the needle coupled thereto.

[0288] Example 3. The apparatus of any example herein, particularly of example 1 or 2, wherein the plunger biasing member comprises a spring.

[0289] Example 4. The apparatus of any one of claims 1 to 3, wherein the handle further comprises a support body defining a body lumen, and wherein the anvil and the plunger extend through the body lumen.

[0290] Example 5. The apparatus of any example herein, particularly of example 4, wherein the plunger is axially movable relative to the support body.

[0291] Example 6. The apparatus of any example herein, particularly of example 4 or 5, wherein the anvil is axially movable relative to the support body.

[0292] Example 7. The apparatus of any example herein, particularly of any one of examples 4 to 6, further comprising a clamp assembly attached to the anvil, the clamp assembly configured to clamp over the needle.

[0293] Example 8. The apparatus of any example herein, particularly of example 7, wherein the clamp assembly is distal to the anvil.

[0294] Example 9. The apparatus of any example herein, particularly of example 7 or 8, wherein the clamp assembly comprises a collet and a clamping collar disposed around the collet, the collet comprising a plurality of fingers.

[0295] Example 10. The apparatus of any example herein, particularly of example 9, wherein distal movement of the clamping collar relative to the collet is configured to urge the fingers towards each other.

[0296] Example 11. The apparatus of any example herein, particularly of example 9 or 10, wherein the collet and the clamping collar are threadedly engaged with each other.

[0297] Example 12. The apparatus of any example herein, particularly of any one of examples 4 to 11, wherein the plunger biasing member is disposed between the plunger and a proximal wall of the support body.

[0298] Example 13. The apparatus of any example herein, particularly of any one of examples 4 to 12, wherein the plunger biasing member is disposed between an outer step defined at a transition from a main body of the plunger to a proximal portion of the plunger, and a body inner step defined by the support body.

[0299] Example 14. The apparatus of any example herein, particularly of any one of examples 4 to 11, wherein the handle further comprises a preload adjustment knob, and wherein the plunger biasing member is disposed between the plunger and an inner step of the preload adjustment knob.

[0300] Example 15. The apparatus of any example herein, particularly of example 14, wherein the plunger biasing member is disposed between an outer step defined at a transition from a main body of the plunger to a proximal portion of the plunger, and the inner step of the preload adjustment knob.

[0301] Example 16. The apparatus of any example herein, particularly of example 14 or 15, wherein the plunger biasing member is disposed inside a central bore of the preload adjustment knob.

[0302] Example 17. The apparatus of any example herein, particularly of any one of examples 4 to 16, wherein the sleeve is disposed around the support body.

[0303] Example 18. The apparatus of any example herein, particularly of example 17, wherein the handle further comprises a plurality of locking balls, each locking ball residing in a radial hole extending through the support body.

[0304] Example 19. The apparatus of any example herein, particularly of example 18, wherein each of the plurality of locking balls is biased radially outwards in a free state thereof.

[0305] Example 20. The apparatus of any example herein, particularly of example 19, wherein each radial hole comprises a cylindrical portion and an inner phase that tapers from the cylindrical portion towards the body lumen.

[0306] Example 21. The apparatus of any example herein, particularly of any one of examples 18 to 20, wherein the plurality of locking balls are circumferentially spaced from each other, and are axially aligned with each other.

[0307] Example 22. The apparatus of any example herein, particularly of any one of examples 18 to 21 , wherein the plunger comprises a plurality of notches configured to accept the plurality of locking balls therein.

[0308] Example 23. The apparatus of any example herein, particularly of any one of examples 18 to 22, wherein the sleeve comprises a narrowed segment configured to be axially aligned with and radially press the locking balls against the plunger in the locking configuration.

[0309] Example 24. The apparatus of any example herein, particularly of example 23, wherein the plunger is configured to axially move relative to the support body, to axially move the narrowed segment away from the locking balls and allow locking balls to be radially spaced from the plunger in the release configuration.

[0310] Example 25. The apparatus of any example herein, particularly of any one of examples 17 to 24, wherein the handle further comprises a sleeve biasing member, configured to bias the sleeve to the locking configuration.

[0311] Example 26. The apparatus of any example herein, particularly of example 25, wherein the sleeve biasing member is configured to bias the sleeve in the distal direction.

[0312] Example 27. The apparatus of any example herein, particularly of example 26, wherein the handle further comprises a sleeve stopper configured to arrest distal movement of the sleeve past the sleeve stopper.

[0313] Example 28. The apparatus of any example herein, particularly of any one of examples 25 to 27, wherein the sleeve biasing member extends between an inner step of the plunger and a first outer step of the support body.

[0314] Example 29. The apparatus of any example herein, particularly of any one of examples 25 to 28, wherein the sleeve biasing member comprises a spring.

[0315] Example 30. The apparatus of any example herein, particularly of any one of examples 17 to 29, wherein the handle further comprises a lever pivotably hinged to the sleeve.

[0316] Example 31. The apparatus of any example herein, particularly of example 30, wherein the handle further comprises a lever biasing member configured to bias a distal end portion of the lever radially outwards relative to the sleeve.

[0317] Example 32. The apparatus of any example herein, particularly of example 31, wherein the lever is configured to prevent proximal retraction of the sleeve when the distal end portion of the lever is biased radially outwards.

[0318] Example 33. The apparatus of any example herein, particularly of example 32, wherein the lever biasing member comprises a spring.

[0319] Example 34. The apparatus of any example herein, particularly of any one of examples30 to 33, wherein the lever biasing member extends between the sleeve and the distal end portion of the lever.

[0320] Example 35. The apparatus of any example herein, particularly of any one of examples30 to 34, wherein the lever biasing member extends into a spring bore of the lever.

[0321] Example 36. The apparatus of any example herein, particularly of any one of examples30 to 35, wherein the handle further comprises a retainer extending radially outwards from the sleeve, and wherein the distal end portion of the lever extends into an opening of the retainer.

[0322] Example 37. The apparatus of any example herein, particularly of any one of examples4 to 36, wherein the support body further comprises a guide slot extending between a slot distal end and a slot proximal end.

[0323] Example 38. The apparatus of any example herein, particularly of example 37, wherein the handle further comprises an axial slider comprising a protrusion extending into the guide slot.

[0324] Example 39. The apparatus of any example herein, particularly of example 38, wherein the axial slider is axially movable between the slot proximal end and a distal-most position of the axial slider which is closer to the slot distal end.

[0325] Example 40. The apparatus of any example herein, particularly of example 39, wherein, when the axial slider is in the distal-most position, the protrusion of the axial slider is configured to prevent distal translation of the plunger past the protrusion.

[0326] Example 41. The apparatus of any example herein, particularly of example 39 or 40, wherein, when the protrusion of the axial slider is in contact with the plunger, proximal movement of the axial slider is configured to proximally drag the plunger therewith.

[0327] Example 42. The apparatus of any example herein, particularly of any one of examples 39 to 41, wherein the support body comprises a stationary magnet, wherein the axial slider comprises a slider magnet, and wherein magnetic attraction between the stationary magnet and the slider magnet is configured to maintain the axial slider in the distal-most position.

[0328] Example 43. The apparatus of any example herein, particularly of any one of examples 39 to 42, wherein the handle further comprises an adjustment knob distal to the axial slider, the adjustment knob configured to axially adjust the distal-most position of the axial slider.

[0329] Example 44. The apparatus of any example herein, particularly of example 43, wherein the adjustment knob is threadedly engaged with the support body.

[0330] Example 45. The apparatus of any example herein, particularly of any one of examples 4 to 44, wherein the handle further comprises a translation restrictor comprising an internal extension which is distal to a stopper of the anvil, and wherein the internal extension is configured to arrest distal movement of the anvil when the stopper contacts the internal extension.

[0331] Example 46. The apparatus of any example herein, particularly of example 45, wherein the stopper extends radially outwards from the anvil.

[0332] Example 47. The apparatus of any example herein, particularly of example 45 or 46, wherein the translation restrictor is threadedly engaged with the support body.

[0333] Example 48. The apparatus of any example herein, particularly of any one of examples 1 to 47, wherein the plunger comprises a plunger lumen.

[0334] Example 49. The apparatus of any example herein, particularly of any one of examples 1 to 48, wherein the needle further comprises a needle head terminating at a needle tip.

[0335] Example 50. The apparatus of any example herein, particularly of any one of examples49, wherein the needle further comprises a needle shaft proximally extending from the needle head.

[0336] Example 51. The apparatus of any example herein, particularly of any one of examples50, wherein the needle shaft comprises a plurality of needle shaft circumferential slits.

[0337] Example 52. The apparatus of any example herein, particularly of any one of examples51 , wherein the needle shaft comprises a needle shaft distal portion comprising the plurality of needle shaft circumferential slits.

[0338] Example 53. The apparatus of any example herein, particularly of any one of examples52, wherein the needle shaft further comprises a needle shaft proximal portion extending proximally from the needle shaft distal portion.

[0339] Example 54. The apparatus of any example herein, particularly of any one of examples53, wherein the needle shaft proximal portion is devoid of circumferential slits.

[0340] Example 55. The apparatus of any example herein, particularly of any one of examples 53 or 54, wherein the proximal portion of the needle shaft comprises a polymeric material.

[0341] Example 56. The apparatus of any example herein, particularly of any one of examples 49 to 55, wherein the needle head defines an angled surface terminating at the needle tip.

[0342] Example 57. A tissue perforation apparatus comprising: a handle comprising: an anvil defining an anvil lumen and comprising at least one anvil lug; a hammer comprising at least one hammer lug; a biasing member configured to distally bias the hammer towards the at least one anvil lug; an anchor control knob configured to rotate the hammer; and a needleadvancement knob proximal to the anchor control knob; an anchor device comprising: an anchor shaft attached to the anvil and configured to axially and rotatably move along with the anvil; and a helical anchor head distal to the anchor shaft; and a needle comprising: a needle shaft coupled to the handle and configured to be axially moved relative to the anchor shaft upon actuation of the needle advancement knob; and a needle head at a distal end of the needle shaft; wherein, upon actuation of the anchor control knob, the hammer is configured to impart rotational impact force to the anvil.

[0343] Example 58. The apparatus of any example herein, particularly of example 57, wherein the needle shaft extends through the anchor shaft.

[0344] Example 59. The apparatus of any example herein, particularly of example 57 or 58, wherein the anchor shaft extends into the anvil lumen.

[0345] Example 60. The apparatus of any example herein, particularly of any one of examples 57 to 59, wherein the handle further comprises a support body defining a support surface, and wherein the biasing member extends between the support surface and the hammer.

[0346] Example 61. The apparatus of any example herein, particularly of example 60, wherein the biasing member extends between the hammer and the support surface and a hammer inner step defined by the hammer.

[0347] Example 62. The apparatus of any example herein, particularly of example 61, wherein the handle further comprises an axial thrust bearing positioned between the hammer inner step and the biasing member.

[0348] Example 63. The apparatus of any example herein, particularly of any one of examples57 to 62, wherein the biasing member comprises a spring.

[0349] Example 64. The apparatus of any example herein, particularly of any one of examples57 to 63, wherein the hammer comprises a hammer bore.

[0350] Example 65. The apparatus of any example herein, particularly of example 64, wherein the anvil comprises an anvil proximal portion extending into the hammer bore.

[0351] Example 66. The apparatus of any example herein, particularly of any one of examples57 to 65, wherein the at least one anvil lug comprises an angled side surface and a flat side surface.

[0352] Example 67. The apparatus of any example herein, particularly of any one of examples57 to 66, wherein the at least one anvil lug comprises a plurality of anvil lugs, and wherein the at least one hammer lug comprises a plurality of hammer lugs.

[0353] Example 68. The apparatus of any example herein, particularly of any one of examples57 to 67, wherein the handle further comprises a radial thrust bearing positioned between an anvil support portion of the handle and an anvil distal portion of the anvil.

[0354] Example 69. The apparatus of any example herein, particularly of any one of examples57 to 68, wherein the hammer further comprises a hammer gear comprising outer gear teeth disposed around the circumference of a hammer proximal portion of the hammer.

[0355] Example 70. The apparatus of any example herein, particularly of example 69, wherein the anchor control knob comprises inner gear teeth.

[0356] Example 71. The apparatus of any example herein, particularly of example 70, wherein the inner gear teeth of the anchor control knob are axially aligned with the hammer gear.

[0357] Example 72. The apparatus of any example herein, particularly of example 70 or 71, wherein rotation of the anchor control knob is configured to rotate the hammer.

[0358] Example 73. The apparatus of any example herein, particularly of any one of examples70 to 72, wherein the handle further comprises one or more idler gears disposed between the anchor control knob and the hammer gear.

[0359] Example 74. The apparatus of any example herein, particularly of example 73, 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 outer gear teeth of the hammer gear.

[0360] Example 75. The apparatus of any example herein, particularly of example 73 or 74, wherein each of the one or more idler gears defines a central bore through which a corresponding support shaft of the handle extends.

[0361] Example 76. The apparatus of any example herein, particularly of example 75, wherein each support shaft distally extends from a plate positioned proximal to the hammer.

[0362] Example 77. The apparatus of any example herein, particularly of any one of examples57 to 76, wherein the needle advancement knob comprises a lead member, and wherein the needle shaft is rigidly attached to a carriage of the handle, wherein the carriage resides inside of and is axially movable relative to the lead member.

[0363] Example 78. The apparatus of any example herein, particularly of example 77, wherein the carriage comprises a head portion which is threadedly engaged with the lead member.

[0364] Example 79. The apparatus of any example herein, particularly of example 78, wherein rotation of the needle advancement knob is configured to cause axial movement of the carriage.

[0365] Example 80. The apparatus of any example herein, particularly of example 78 or 79, wherein the carriage further comprises a rear port extending proximally from the head portion.

[0366] Example 81. The apparatus of any example herein, particularly of example 80, wherein the carriage defines a carriage bore extending therethrough.

[0367] Example 81. The apparatus of any example herein, particularly of any one of examples57 to 81, wherein the anchor shaft is a flexible torque shaft configured transmit rotational movement thereof, when rotated along with the anvil by the anchor control knob, to the helical anchor head.

[0368] Example 83. The apparatus of any example herein, particularly of example 82, wherein the anchor shaft comprises a helical hollow strand tube.

[0369] Example 84. The apparatus of any example herein, particularly of any one of examples57 to 83, wherein the helical anchor head comprises a plurality of helical turns and terminates with an anchor tip.

[0370] Example 85. The apparatus of any example herein, particularly of any one of examples57 to 84, wherein the needle head defines an angled surface terminating at a needle tip.

[0371] Example 86. The apparatus of any example herein, particularly of any one of examples57 to 85, wherein the needle shaft comprises a needle shaft distal portion comprising a plurality of circumferential slits.

[0372] Example 87. The apparatus of any example herein, particularly of example 86, wherein the needle shaft further comprises a proximal portion extending proximally from the distal portion of the needle shaft.

[0373] Example 88. The apparatus of any example herein, particularly of example 87, wherein the proximal portion of the needle shaft is devoid of circumferential slits.

[0374] Example 89. The apparatus of any example herein, particularly of example 88, wherein the proximal portion of the needle shaft comprises a polymeric material.

[0375] Example 90. The apparatus of any example herein, particularly of any one of examples57 to 89, further comprising a delivery catheter rigidly attached, at a delivery catheter proximal end portion thereof, to the handle.

[0376] Example 91. The apparatus of any example herein, particularly of example 90, wherein the anchor shaft extends through the delivery catheter.

[0377] Example 92. A tissue perforation method comprising: positioning a tissue perforating apparatus proximate to a target tissue, the tissue perforating apparatus comprising a delivery catheter, a needle, a plunger, and a sleeve, wherein the sleeve is movable between a locking configuration and a release configuration; and forming a pilot puncture on the target tissue by actuating the sleeve of the leaflet perforating apparatus to move the sleeve from the lockingconfiguration to the release configuration, wherein the sleeve, when in the release configuration, allows distal movement of the plunger towards the needle, which causes distal movement of the needle toward the target tissue.

[0378] Example 93. A tissue perforation apparatus comprising: a handle comprising: a sleeve configured to move between a locking configuration and a release configuration; and a plunger, wherein the plunger is axially immovable relative to the sleeve when the slee ve is in the locking configuration, and wherein the plunger is axially moveable relative to the sleeve when the sleeve is in the release configuration; and a needle; wherein, moving the sleeve from the locking configuration to the release configuration allows the plunger to move distally toward and strike the needle to cause distal movement of the needle toward the target tissue

[0379] 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.

[0380] 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: an anvil defining an anvil proximal surface; a plunger proximal to the anvil; a sleeve configured to move between a locking configuration, in which the plunger is axially immovable relative to the sleeve, and a release configuration, in which the anvil is allowed to axially move relative to the sleeve; and a plunger biasing member configured to distally bias the plunger; and a needle coupled to the anvil and extending therefrom; wherein, when the plunger is positioned in a proximal position thereof, and the plunger biasing member is in a loaded state against the plunger, moving the sleeve from the locking configuration to the release configuration allows the plunger biasing member to distally urge the plunger towards the anvil.

2. The apparatus of claim 1, wherein, when the plunger is distally urged by the plunger biasing member towards the anvil, it strikes against the anvil at an impact force that results in distal movement of the anvil and the needle coupled thereto.

3. The apparatus of any one of claims 1 or 2, wherein the handle further comprises a support body defining a body lumen, and wherein the anvil and the plunger extend through the body lumen.

4. The apparatus of claim 3, further comprising a clamp assembly attached to the anvil, the clamp assembly configured to clamp over the needle.

5. The apparatus of any one of claims 3 or 4, wherein the handle further comprises a preload adjustment knob, and wherein the plunger biasing member is disposed between the plunger and an inner step of the preload adjustment knob.

6. The apparatus of any one of claims 3 to 5, wherein the sleeve is disposed around the support body.

7. The apparatus of claim 6, wherein the handle further comprises a sleeve biasing member, configured to bias the sleeve to the locking configuration.

8. The apparatus of any one of claims 6 or 7, wherein the handle further comprises a lever pivotably hinged to the sleeve.

9. The apparatus of claim 8, wherein the handle further comprises a lever biasing member configured to bias a distal end portion of the lever radially outwards relative to the sleeve.

10. The apparatus of claim 9, wherein the lever is configured to prevent proximal retraction of the sleeve when the distal end portion of the lever is biased radially outwards.

11. The apparatus of any one of claims 3 to 10, wherein the support body further comprises a guide slot extending between a slot distal end and a slot proximal end.

12. The apparatus of claim 11, wherein the handle further comprises an axial slider comprising a protrusion extending into the guide slot.

13. The apparatus of claim 12, wherein the axial slider is axially movable between the slot proximal end and a distal-most position of the axial slider which is closer to the slot distal end.

14. The apparatus of claim 13, wherein, when the axial slider is in the distal-most position, the protrusion of the axial slider is configured to prevent distal translation of the plunger past the protrusion.

15. The apparatus of claim 13 or 14, wherein, when the protrusion of the axial slider is in contact with the plunger, proximal movement of the axial slider is configured to proximally drag the plunger therewith.

16. The apparatus of any one of claims 13 to 15, wherein the handle further comprises an adjustment knob distal to the axial slider, the adjustment knob configured to axially adjust the distal-most position of the axial slider.

17. A tissue perforation apparatus comprising: a handle comprising: an anvil defining an anvil lumen and comprising at least one anvil lug; a hammer comprising at least one hammer lug; a biasing member configured to distally bias the hammer towards the at least one anvil lug; an anchor control knob configured to rotate the hammer; and a needle advancement knob proximal to the anchor control knob; an anchor device comprising: an anchor shaft attached to the anvil and configured to axially and rotatably move along with the anvil; and a helical anchor head distal to the anchor shaft; and a needle comprising: a needle shaft coupled to the handle and configured to be axially moved relative to the anchor shaft upon actuation of the needle advancement knob; and a needle head at a distal end of the needle shaft;wherein, upon actuation of the anchor control knob, the hammer is configured to impart rotational impact force to the anvil.

18. The apparatus of claim 17, wherein the handle further comprises a support body defining a support surface, and wherein the biasing member extends between the support surface and the hammer.

19. The apparatus of any one of claims 17 or 18, wherein the hammer comprises a hammer bore.

20. The apparatus of claim 19, wherein the anvil comprises an anvil proximal portion extending into the hammer bore.

21. The apparatus of any one of claims 17 to 20, wherein the hammer further comprises a hammer gear comprising outer gear teeth disposed around the circumference of a hammer proximal portion of the hammer.

22. The apparatus of claim 21, wherein the anchor control knob comprises inner gear teeth.

23. The apparatus of claim 22, wherein rotation of the anchor control knob is configured to rotate the hammer.

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