Transcatheter devices for removing calcification

Abstract

Transcatheter devices include a distal end with a cavitation device. The cavitation device includes a pivot arm comprising a proximal portion pivotally mounted to a base of the cavitation device and configured to be pivoted between an open position where a distal portion of the pivot arm is at least partially positioned outside of a channel of the cavitation device. The pivot arm is further configured to be pivoted to a closed position where the distal portion of the pivot arm is at least partially positioned within the channel. Methods of removing calcification from a patient include orienting the cavitation device to target a calcium deposit at a treatment site. The methods further includes pivoting the pivot arm of the cavitation device from the open position to the closed position, wherein a pressure pulse wave is generated within a fluid that removes a portion of the calcium deposit.

Description

TRANSCATHETER DEVICES FOR REMOVING CALCIFICATIONCROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 622,835, filed January 19, 2024, the entire content of which is incorporated herein by reference.FIELD

[0002] The present disclosure relates generally to transcatheter devices and methods of removing calcium deposits and, more particularly, to transcatheter devices comprising a cavitation device and methods for removing calcium deposits within a patient by generating pressure pulse waves with a cavitation device of a transcatheter device.BACKGROUND

[0003] In some patients, a heart valve may become damaged or diseased, such as for example, where a patient is suffering from stenotic calcification. More specifically, stenotic calcification is a heart valve disorder that is characterized by the formation of calcium deposits on leaflets of the heart valve. This progressive disease is widely prevalent today and may result in a narrowing of the heart valve opening. The narrowing of the heart valve opening leads to a reduction in blood flow through the heart valve.

[0004] Once calcification of the heart valve leaflets develops, there are limited options for treatment. One such treatment option is performing a balloon valvuloplasty. This involves placing a balloon within a position of the narrowed heart valve and inflating it to widen the narrowed passageway. However, one drawback of this procedure is that it is unlikely to resolve the issue and may require ongoing procedures.

[0005] Another procedure that may be used to correct calcification of the heart valve leaflets is a surgical or transcatheter based heart valve replacement. However, both of these heart valve replacement options may have complications, and in many younger patients, multiple operations may be required over time, such as for example a valvein-valve procedure, which is associated with other long-term risks (e.g., a lack of coronary access).

[0006] There is a desire for a device that can break-up and remove calcification from heart valve leaflets and / or the surrounding area in conjunction with an embolic protection device.SUMMARY

[0007] The following presents a simplified summary of the disclosure to provide a basic understanding of some aspects described in the detailed description.

[0008] Features of the present disclosure provide a transcatheter device having a cavitation device that produces a pressure pulse wave. Providing a transcatheter device with a cavitation device can allow a clinician to reliably remove calcium deposits from a patient to help treat various diseases, such as calcification of a heart valve.

[0009] In aspects, transcatheter devices comprise a shaft comprising a proximal end and a distal end. A handle device is coupled to the proximal end of the shaft and the handle device comprises an actuator. The transcatheter devices further comprise a cavitation device coupled to the distal end of the shaft. The cavitation device comprises a base extending in a distal direction from a proximal end portion of the base to a distal end portion of the base. The base comprises an outer peripheral surface extending from the proximal end portion to a distal opening of the distal end portion. The base further comprising a channel extending in the distal direction and open to the outer peripheral surface and the distal opening of the base. The cavitation device further comprises a pivot arm comprising a proximal portion pivotally mounted to the base and configured to be pivoted between an open position and a closed position. The actuator is configured to be activated to move the pivot arm from the open position to the closed position.

[0010] In further aspects, methods of removing calcification from a patient with a transcatheter device comprise delivering a cavitation device to a target treatment site of the patient, and orienting the cavitation device to target a calcium deposit. The methods can further comprise pivoting a pivot arm of the cavitation device from an open position to a closed position, wherein a pressure pulse wave is generated within a fluid that removes a portion of the calcium deposit.BRIEF DESCRIPTION OF THE DRAWINGS

[0011] These and other features, aspects and advantages are better understood when the following detailed description is read with reference to the accompanying drawings, in which:

[0012] FIG. 1 is a schematic top view of an exemplary transcatheter device in accordance with aspects of the present disclosure;

[0013] FIG. 2 is an enlarged schematic top view of a distal end of the exemplary transcatheter device taken at view 2 of FIG. 1 showing a top view of an exemplary cavitation device in accordance with aspects of the present disclosure;

[0014] FIG. 3 is a schematic front view of the of the exemplary cavitation device taken along line 3-3 of FIG. 2 in accordance with the present disclosure.

[0015] FIG. 4 is a schematic cross-sectional view taken along line 4-4 of FIG. 2, showing the exemplary cavitation device with a pivot arm in a closed position in accordance with the present disclosure;

[0016] FIG. 5 is a schematic cross-sectional view taken along line 5-5 of FIG. 1; showing an exemplary handle device of the transcatheter device in accordance with the present disclosure;

[0017] FIG. 6 is a schematic cross-sectional view showing an actuator of the handle device of FIG. 5 in a locked position in accordance with the present disclosure;

[0018] FIG. 7 is a schematic cross-sectional view taken along line 4-4 of FIG. 2 showing the exemplary cavitation device with the pivot arm in an open position in accordance with the present disclosure;

[0019] FIG. 8 is a schematic cross-sectional view of an exemplary shaft taken along line 8-8 of FIG. 1 in accordance with the present disclosure;

[0020] FIGS. 9-13 illustrate example steps in a method of removing calcification from a treatment site of a patient in accordance with the present disclosure.DETAILED DESCRIPTION

[0021] Aspects will now be described more fully hereinafter with reference to the accompanying drawings in which example aspects are shown. Whenever possible, the same reference numerals are used throughout the drawings to refer to the same or like parts. However, this disclosure may be embodied in many different forms and should not be construed as limited to the aspects set forth herein.

[0022] As used herein, the term “about” means that amounts, sizes, formulations, parameters, and other quantities and characteristics are not, and need not be, exact, but may be approximate and / or larger or smaller, as desired, reflecting tolerances, conversion factors, rounding off, measurement error and the like, and other factors known to those of skill in the art.

[0023] Ranges can be expressed herein as from “about” one value, and / or to “about” another value. When such a range is expressed, aspects include from the one value to the other value. Similarly, when values are expressed as approximations by use of the antecedent “about,” it will be understood that the value forms another aspect. It will be further understood that the endpoints of each of the ranges are significant both in relation to the other endpoint, and independently of the other endpoint.

[0024] Directional terms as used herein - for example up, down, right, left, front, back, top, bottom, upper, lower, etc. - are made only with reference to the figures as drawn and are not intended to imply absolute orientation.

[0025] Unless otherwise expressly stated, it is in no way intended that any methods set forth herein be construed as requiring that its steps be performed in a specific order, nor that with any apparatus, specific orientations be required. Accordingly, where a method claim does not actually recite an order to be followed by its steps, or that any apparatus claim does not actually recite an order or orientation to individual components, or it is not otherwise specifically stated in the claims or description that the steps are to be limited to a specific order, or that a specific order or orientation to components of an apparatus is not recited, it is in no way intended that an order or orientation be inferred in any respect. This holds for any possible non-express basis for interpretation, including matters of logic relative to arrangement of steps, operational flow, order of components, or orientation of components; plain meaning derived from grammatical organization or punctuation, and; the number or type of aspects described in the specification.

[0026] As used herein, the singular forms "a," "an," and "the" include plural references unless the context clearly dictates otherwise. Thus, for example, reference to “a” component includes aspects having two or more such components, unless the context clearly indicates otherwise.

[0027] The word “exemplary,” “example,” or various forms thereof are used herein to mean serving as an example, instance, or illustration. Any aspect or design described herein as “exemplary” or as an “example” should not be construed as preferred or advantageous over other aspects or designs. Furthermore, examples are provided solely for purposes of clarity and understanding and are not meant to limit or restrict the disclosed subject matter or relevant portions of this disclosure in any manner. It can be appreciated that a myriad of additional or alternate examples of varying scope could have been presented but have been omitted for purposes of brevity.

[0028] As used herein, the terms “comprising,” “including,” and variations thereof shall be construed as synonymous and open-ended, unless otherwise indicated. A list of elements following the transitional phrases comprising or including is a nonexclusive list, such that elements in addition to those specifically recited in the list may also be present.

[0029] The terms “substantial,” “substantially,” and variations thereof as used herein are intended to represent that a described feature is equal or approximately equal to a value or description. For example, a “substantially planar” surface is intended to denote a surface that is planar or approximately planar. Moreover, “substantially” is intended to denote that two values are equal or approximately equal. The term “substantially” may denote values within about 10% of each other, for example, within about 5% of each other, or within about 2% of each other.

[0030] Modifications may be made to the instant disclosure without departing from the scope or spirit of the claimed subject matter. Unless specified otherwise, “first,” “second,” or the like are not intended to imply a temporal aspect, a spatial aspect, an ordering, etc. Rather, such terms are merely used as identifiers, names, etc. for features, elements, items, etc. For example, a first end and a second end generally correspond to end A and end B or two different ends.

[0031] Unless otherwise indicated, the terms “distal” and “proximal” are used in the following description with respect to a position or direction relative to the treating clinician. “Distal” and “distally” are positions distant from or in a direction away from the clinician, and “proximal” and “proximally” are positions near or in a direction toward the clinician. In addition, the term “self-expanding” may be used in the following description with reference to one or more valve or stent structures of the prostheses hereof and is intended to convey that the structures are shaped or formed from a material that can be provided with a mechanical memory to return the structure from a compressed or constricted delivery configuration to an expanded deployed configuration or vice versa. Non-exhaustive exemplary self-expanding materials include stainless steel, a pseudo-elastic metal such as a nickel titanium alloy or nitinol, various polymers, or a so-called super alloy, which may have a base metal of nickel, cobalt, chromium, or other metal. Mechanical memory may be imparted to a wire or stent structure by thermal treatment to achieve a spring temper in stainless steel, for example, or to set a shape memory in a susceptible metal alloy, such as nitinol. Various polymers that can be made to have shape memory characteristics may also be suitablefor use in aspects hereof to include polymers such as polynorborene, transpolyisoprene, styrene -butadiene, and polyurethane. As well poly L-D lactic copolymer, oligo caprylactone copolymer and poly cyclo-octine can be used separately or in conjunction with other shape memory polymers.

[0032] Diseases associated with heart valves caused by damage or defect, can included calcific aortic stenosis. For example, calcific aortic stenosis can cause the heart valve to become narrowed and hardened which can prevent blood flow to a downstream heart chamber from occurring at the proper flow rate and may cause the heart to work harder to pump the blood through the diseased heart valve. A diseased or damaged heart valve, which can be congenital, age-related, drug-induced, or in some instances, caused by infection, can result in an enlarged, thickened heart that loses elasticity and efficiency. Some symptoms of heart valve diseases can include weakness, shortness of breath, dizziness, fainting, palpitations, anemia and edema, and blood clots which can increase the likelihood of stroke or pulmonary embolism. Symptoms can often be severe enough to be debilitating and / or life threatening. For this reason, it is important to treat heart valve calcification.

[0033] FIG. 1 illustrates an exemplary transcatheter device 100. The exemplary transcatheter device 100 described herein may be used to remove calcium deposits from a prosthetic heart valve, a native heart valve(s), and / or a surrounding area (e.g., the area surrounding the native or prosthetic heart valve(s)). Furthermore, the transcatheter device 100 is not limited to removing calcium from heart valve. The transcatheter device 100 may further be advantageous in removing various other calcified regions within a patient.

[0034] FIG. 1 is a schematic top view of the transcatheter device 100. As shown in FIG. 1, the transcatheter device 100 can comprise a shaft 800, a handle device 500, and a cavitation device 200.

[0035] In aspects, the shaft 800 comprises a proximal end 105 and a distal end 107. In some aspects, the handle device 500 can be coupled to the proximal end 105 of the shaft 800, as shown in FIG. l. For example, the handle device 500 can be coupled to the proximal end 105 of the shaft 800 in a number of ways, such as for example, by one or more mechanical fasteners (e.g., screws, nuts and / or bolts). In other examples, the handle device 500 and the shaft 800 can also be formed as a monolithic structure. The handle device 500 can assist a clinician in maneuvering the transcatheter device 100 through the patient’s vasculature. For example, the clinician can manipulate (i.e., rotate,push, pull and / or any combination thereof) the handle device 500 to maneuver the transcatheter device 100 into a target location within a patent’s heart, such as for example, maneuvering the transcatheter device 100 through an incision in the patients groin, and further maneuvering the transcatheter device 100 into a heart valve (i.e., the aortic valve).

[0036] In some aspects, the handle device 500 can comprise an actuator 501. For example, the actuator 501 can comprise a single actuator, such as for example, a button, a sliding mechanism, or any other suitable actuator. In some aspects, the actuator 501 can further comprise more than one actuator. For example, the actuator 501 can comprise two or more actuators. In aspects, the actuator 501 can interact with the cavitation device 200 in a number of ways, which will be described and become apparent hereinafter.

[0037] In some aspects, the transcatheter device 100 comprises a cavitation device 200 coupled to the distal end 107 of the shaft 800, as shown in FIG. 1. For example, the cavitation device 200 can be coupled to the distal end 107 of the shaft 800 in a number of ways, such as for example, by one or more mechanical fasteners (e.g., screws, nuts and / or bolts). In other examples, the cavitation device 200 and the shaft 800 can also be formed as a monolithic structure.

[0038] As shown in FIG. 2, the cavitation device 200 can comprise a base 201 and a pivot arm 401 pivotally attached to the base 201. The base 201 can extend in a distal direction from a proximal end portion 203 to a distal end portion 205. In aspects, the base 201 comprises an outer peripheral surface 207 extending from the proximal end portion 203 to the distal end portion 205. For example, the outer peripheral surface 207 can comprise a cylindrical shape as shown in FIGS. 2-3.

[0039] In some examples, the outer peripheral surface 207 can be the sized to have the same diameter and shape as the shaft 800 such that when the cavitation device 200 is coupled to the distal end 107 of the shaft 800, an outer surface of the shaft 800 and an outer surface of the peripheral wall form a continuous and uninterrupted surface. This may be especially advantageous in maintaining an atraumatic structure to prevent and / or minimize injury or trauma to a patient when delivering the cavitation device 200 through the patent’s vasculature to the treatment site.

[0040] In other examples, the outer peripheral surface 207 can be any number of shapes, such as for example, a conical or nozzle shape and / or any other suitable shape.In other examples, the outer peripheral surface 207 can have a diameter greater than or smaller than the shaft 800.

[0041] In some aspects, the base 201 can further comprise a channel 211 extending in the distal direction and open to the outer peripheral surface 207 and a distal opening 209 of the base 201 (best shown in FIG. 3). As shown in FIG. 2, in some examples, the channel 211 can extend through a proximal end 213 of the proximal end portion 203. In other examples, the channel 211 can extend only partially through a length of the proximal end portion 203 of the base 201. For example, the channel 211 can terminate prior to reaching the proximal end 213 of the proximal end portion 203.

[0042] As shown, the channel 211 can be open to the outer peripheral surface 207 and the distal opening 209 and can therefore be exposed to the surrounding environment. For example, when the cavitation device 200 is inserted within the vasculature of a patient, blood will be able to freely enter the channel through the opening at the outer peripheral surface 207 of the base 201 and / or the distal opening 209 of the base 201 to fill empty areas of the channel 211 with blood..

[0043] In aspects, a depth of the channel 211 can be any number of suitable depths. For example, the channel 211 can extend a depth from the outer peripheral surface 207 to a center of the base 201. In other examples, the channel 211 can extend a depth further or lesser than the center of the base 201. In some aspects, the channel 211 can be open to the distal opening 209 of the base 201 by the entire depth of the channel 211 or less than an entire depth of the channel.

[0044] As shown in FIGS. 4 and 5, the pivot arm 401 can comprise a proximal portion 403 pivotally mounted to the base 201 and configured to be pivoted between an open position 701 (shown in FIG. 7) and a closed position 407 (shown in FIG. 4). As shown in FIG. 7, in the open position 701, the distal portion 405 of the pivot arm 401 can be pivoted away from an interior surface 421 of the channel 211. In some embodiments, in the open position 701 (shown in FIG. 7), the distal portion 405 of the pivot arm 401 can be at least partially positioned outside of the channel 211 although the distal portion 405 may be positioned within the channel 211 in the open position in further embodiments. As shown in FIG. 4, in the closed position 407, the distal portion 405 of the pivot arm can be pivoted towards the interior surface 421 of the channel 211 to be positioned closer to the interior surface 421 of the channel 211 in the closed position than in the open position. As further illustrated in FIG. 4, in some embodiments, the distal portion 405 of the pivot arm 401 can be at least partially (e.g., entirely) positionedwithin the channel 211 in the closed position although a portion of the distal portion 405 of the pivot arm 401 may extend partially outside of the channel in the closed position in further embodiments.

[0045] In some aspects, a pin 402 can pivotally mount the proximal portion 403 of the pivot arm 401 to the base 201. For example, the pin 402 can comprise a straight pin (i.e., a dowel pin) that is disposed in the base 201 such that the pivot arm 401 can pivot between the open position 701 and the closed position 407. In other aspects, various other pins configured to allow the pivot arm 401 to rotate been the open position 701 and the closed position 407 can be utilized (i.e., a clevis pin). The pin 402 can be a variety of suitable materials, such as for example, metal, plastic, ceramic, or any other suitable material.

[0046] In some aspects, the pivot arm 401 can be pivotally mounted to the base 201 to allow for a number of suitable degrees of rotation of the pivot arm 401. For example, the pivot arm 401 can be pivotally mounted to allow for the pivot arm 401 to pivot 180 degrees between the open and closed position. For example, the pivot arm 401 can be pivotally mounted such that the pivot arm 401 can rotate counterclockwise about the pin 402 shown in FIG. 4 to reach the open position 701 shown in FIG. 7. The pivot arm may rotate 180 degrees although greater or reduced rotation may be provided in further embodiments. Furthermore, there may be a pivot stop designed to limit the extent that the pivot arm is able to pivot about the pin 402. For example, as shown in FIG. 7, a pivot stop can limit the pivot arm 401 to pivot a predetermined angle (e.g., 45 degrees) counterclockwise about the pin 402 from the closed position shown in FIG. 4 to the open position shown in FIG. 7. In other aspects, the pivot arm 401 can rotate greater than or less than 45 degrees.

[0047] In aspects, the distal portion 405 of the pivot arm 401 can comprise a plunger 409. In some aspects, the plunger 409 comprises a contoured surface 411 that is configured to accommodate an ingress of a fluid (not shown). For example, as a result of the contoured surface 411, when the pivot arm 401 moves from the open position 701 to the closed position 407, the fluid will be displaced by the plunger 409 (e.g., to produce the pressure pulse wave 1101). In some aspects, the contoured surface 411 can comprise a concave surface, a convex surface, a planar surface and / or any combination thereof. It will be appreciated that various degrees of cavitation can be produced by varying the shape of contoured surface 411.

[0048] In further aspects, the pivot arm 401 can comprise one or more radiopaque markers (e.g., one radiopaque marker, two radiopaque markers, three radiopaque markers, etc.). For example, the one or more radiopaque markers can optionally be disposed along a length of the pivot arm 401. In some aspects, the one or more radiopaque markers can be disposed along the proximal portion 403 of the pivot arm 401. In other aspects, the one or more radiopaque markers can be disposed along a length of the distal portion 405. In further aspects, the one or more radiopaque markers can be disposed on the plunger 409. For example, the one or more radiopaque markers can be disposed on an upper portion of the plunger 409, such as for example, along a downwardly sloping upper surface of the plunger 409. In some aspects, any radiopaque material known in the art may be used for the one or more radiopaque markers. For example, gold, platinum, platinum / iridium, titanium, tantalum, barium silicate, tungsten and / or the like may be utilized for the one or more radiopaque markers. The one or more radiopaque markers should comprise a material that is discernable from other components of the cavitation device 200. For example, if titanium is utilized in the pivot arm 401 and / or the plunger 409, a material other than titanium should be utilized for the one or more radiopaque markers. In this way, the pivot arm 401 and / or the plunger 409 will be able to be located by a clinician (e.g., a surgeon) when maneuvering the cavitation device 200 within the vasculature of a patient. For example, a clinician can utilize fluoroscopic imaging of the one or more radiopaque markers while maneuvering the cavitation device within the vasculature of a patient.

[0049] In some aspects, the base 201 and the plunger 409 define a seated interface 413 when the pivot arm 401 is in the closed position 407. For example, as shown in FIG. 4, to form the seated interface 413, the base 201 can comprise a protrusion 417 and the distal portion 405 of the pivot arm 401 can comprise a groove 415 configured to receive the protrusion 417 in the closed position to establish the seated interface 413. The protrusion 417 can comprise an elongated protrusion which is shaped to be snuggly seated in a complimentary shaped elongated groove 415 of the pivot arm 401. The elongated groove 415 can comprise a concave surface that contours to match the convex surface of the elongated protrusions 417. Providing a snug fit at the seated interface can help trap fluid from traveling backward within the channel 211 when snapping the pivot arm 401 shut from the open position to the closed position. As such, a more powerful pressure pulse wave 1101 can be produced. While the illustrated seated interface 413 comprises a convex / concave surface interface, in further embodiments,the seated interface may comprise other configurations such as a tooth and gear interface or a ball and socket interface and / or the like.

[0050] In some aspects, with reference to FIG. 4, when the pivot arm 401 is in the closed position 407, the plunger 409 can form a chamber 419 between the contoured surface 411 of the plunger 409 and the interior surface 421 of the channel 211. In aspects, the chamber 419 can comprise one or more surfaces. For example, the chamber 419 can comprise a pair of opposed lateral surfaces (i.e., surfaces formed from base 201) of the channel 211, the interior surface 421 and the contoured surface 411. As shown in the interior surface 421 comprises an inner surface facing the pivot arm 401 and positioned between the opposed lateral surfaces of the channel 211. In some aspects, as shown in FIG. 4, the chamber 419 can comprise a gap 423 open to the environment. For example, when the cavitation device 200 enters the vasculature of a patient, the gap 423 allows the chamber 419 to fill with blood. In some aspects, the gap 423 can be omitted and the chamber 419 can be isolated from its environment. In this case, the chamber 419 can be provided with a different fluid than that of its surrounding environment for creating cavitation. The size and shape of the gap 423 can also intensify the pressure pulse wave 1101 developed when snapping the pivot arm 401 shut from the open position 701 to the closed position 407.

[0051] In some aspects a height and / or a width of the gap 423 can be smaller than a height and / or a width of the chamber 419. For example, as shown in FIGS. 4 and 6, a raised surface 425 can extend the width of the chamber 419 to reduce the height of the gap 423. The height of the gap 423 can be especially helpful in controlling the strength of the pressure pulse wave 1101 produced by the cavitation device 200.

[0052] With reference to FIG. 5, the handle device 500 is illustrated comprising the actuator 501. In aspects, the actuator 501 is configured to be activated to move the pivot arm 401 from the open position 701 to the closed position 407. In some aspects, the actuator 501 further comprises a first tether 503 coupled to the pivot arm 401 and configured to move the pivot arm 401 to the open position 701. For example, the first tether 503 may be coupled to the pivot arm 401 by any suitable coupling means known in the art, such as for example, a loop and hook connection, a double loop couple and / or the like. As shown in FIG. 4, the first tether 503 can be coupled to the pivot arm 401 (shown generally at a first coupled portion 505 in FIG. 4) along an upper portion 427 of the pivot arm 401. The first tether 503 can be coupled to any suitable location along the upper portion 427 of the pivot arm 401. For example, as the first tether 503 iscoupled closer to the distal portion 405 of the pivot arm 401, the moment about the proximal portion 403 of the pivot arm 401 is also increased. Furthermore, as the moment between the first coupled portion 505 and the proximal portion 403 is increased, the force required by the actuator 501 to rotate the pivot arm 401 from the closed position 407 to the open position 701 will decrease.

[0053] In some aspects, the actuator 501 comprises the first tether 503 coupled to the pivot arm 401 and a second tether 531 coupled to the pivot arm 401, as shown in FIG. 4. In some examples, the second tether 531 can be coupled to the pivot arm 401 using the same coupling means described for the first tether 503. In other examples, the second tether 531 may be coupled utilizing different coupling means (e.g., the first tether 503 is coupled to the pivot arm 401 with a hook and loop couple, and the second tether 531 is coupled to the pivot arm 401 with a double loop couple). In aspects, the second tether 531 is configured to bias the pivot arm 401 to the closed position 407. Furthermore, in some aspects, the actuator 501 further comprises a spring 533 configured to bias the pivot arm 401 to the closed position 407. For example, in a particular embodiment (shown in FIG. 4), the spring 533 can be coupled to the second tether 531 to bias the pivot arm 401 to the closed position 407. In this particular example, the second tether 531 can be coupled to a lower portion 429 of the pivot arm 401 (shown generally at a second coupled portion 506 in FIG. 4).

[0054] In some examples, the spring 533 and the second tether 531 can be positioned within the handle device 500. Pivoting the pivot arm 401 from the closed position 407 to the open position 701 places the spring 533 in tension to apply a force 703 to the pivot arm 401 with the second tether 531. As such, the second tether 531 is placed in tension by the spring 533 to apply the force 703 to the pivot arm 401 and thereby bias the pivot arm 401 from the open position 701 to the closed position 407.

[0055] In some embodiments, the tension in the spring 533 can be adjusted to increase or decrease the force 703 applied to the pivot arm 401 when the pivot arm 401 is in the open position 701. Adjusting the tension in the spring 533 to adjust the force 703 can increase or decrease the rate that the pivot arm 401 snaps shut and can therefore adjust the power of the pressure pulse wave 1101 generated by the cavitation device 200. For example, as shown in FIG. 5, a thumb screw 550 may be rotated to adjust the tension in the spring 533.

[0056] Although the illustrated embodiment shows the spring 533 positioned at the proximal end of the second tether 531, in further embodiments, although not shown,the spring may be provided at the distal end of the tether. In such embodiments, the spring may be directly attached to the pivot arm and provide the connection between the pivot arm and the second tether. In further embodiments, although not shown, the second tether and the spring may be integrated together as the same component. For example, the second tether can comprise an elastic tether configured to stretch to store energy. As such, pivoting the pivot arm from the closed position to the open position would stretch the second elastic tether, thereby storing potential energy in the second tether. The second tether would thereby be placed in tension and bias the pivot arm from the open position to the closed position. Once triggered, the potential energy within the elastic second tether would apply the force to pivot arm to snap the pivot arm closed. In still further embodiments, although not shown, the spring may be provided in the cavitation device without a second tether. In such embodiments, a spring in the cavitation device itself may provide the biasing of the pivot arm from the open position to the closed position without a tether.

[0057] The first tether 503 and the second tether 531 can be a variety of suitable materials. For example, the first tether 503 can be a resilient material with a tendency to conform back to its original shape. For example, materials with a relatively small Young’s modulus can be suitable, such as for example, elastomers. In some aspects, the first tether 503 can be a material with a relatively high Young’s modulus, such as for example, alloys and / or a variety of other metals. In some aspects, the first tether 503 can be formed from high-strength synthetic fibers, such as for example, nylon and / or polyester. The first tether 503 material should by no means be limited to the above- mentioned materials and can be any other suitable material to move the pivot arm 401 from the closed position 407 to the open position 701. In some examples, the second tether 531 can be a resilient material such that the second tether 531 biases the pivot arm 401 to the closed position 407. In such an example, the spring 533 can be omitted. In some examples, the second tether 531 and the spring 533 can work in tandem with one another to bias the pivot arm 401 to the closed position 407 (e.g., the second tether 531 is in tension due to its resilient material and the spring 533 is in tension).

[0058] In some aspects, the actuator 501 is configured to slide to set the pivot arm 401 into the open position 701. For example, the actuator 501 can be configured to slide in the proximal direction 529 (indicated by the arrow at 529 of FIGS. 4-5) or the distal direction 601 (indicated by the arrow at 601 of FIG. 6) within a groove 507 formed in the handle device 500. In aspects, the actuator 501 is configured to increase tension inthe first tether 503 by a sliding movement of the actuator 501 in the proximal direction 529 to move the pivot arm 401 to the open position 701.

[0059] In some aspects, the actuator 501 can be a variety of shapes and sizes. For example, the actuator 501 can comprise a sloped surface 509 comprising rigid protrusions 511 to facilitate a clinician in operating the actuator 501. For example, the sloped surface 509 and rigid protrusions 511 will be beneficial in providing a surface for the clinician to slide the actuator 501 in the proximal direction 529.

[0060] In some non-limiting aspects, the actuator 501 can be a motorized linear actuator (not shown). For example, the clinician could operate the actuator 501 by pressing a button that electrically activates a motor to drive the actuator 501 in the proximal direction 529, thereby rotating the pivot arm 401 from the closed position 407 to the open position 701. Although the actuator 501 has been described herein in terms of linear movement, the actuator 501 should not be limited by such operations and may work with a variety of other types of movements (i.e., rotational movements). Furthermore, the actuator 501 can be a variety of other suitable shapes and / or sizes for assisting the clinician in activating the actuator 501.

[0061] In some aspects, the actuator 501 can comprise a locking device 513 configured to lock the actuator 501 in the proximal direction 529 in a locked position 603 (shown in FIG. 6) to maintain tension in the first tether 503. In aspects, when the locking device 513 is released from the locked position 603, the tension in the spring 533 snaps the pivot arm 401 to the closed position 407. As used herein, the term “snaps” refers to the pivot arm 401 moving from the open position 701 to the closed position 407 with enough velocity to produce cavitation resulting in the pressure pulse wave 1101 being formed.

[0062] In some aspects, the locking device 513 can comprise a lever 515, a release button 517, a biasing device 519, a first latch 521, and a second latch 523. In some aspects, the lever 515 can comprise an elongated arm with the first latch 521 coupled to a first end 525 of the elongated arm and the release button 517 coupled to a second end 527 of the elongated arm. In some aspects, the second latch 523 is coupled to the actuator 501 and configured to interact with the first latch 521 to lock the actuator 501 into the locked position 603. In some aspects, the biasing device 519 is configured to bias the first latch 521 radially outward with respect to the handle device 500. For example, the biasing device 519 can comprise a compression spring.

[0063] In some aspects, the first latch 521 can comprise a first rounded surface 522 and the second latch 523 can comprise a second rounded surface 524. The first rounded surface 522 and the second rounded surface 524 can be configured to contact each other such that the second latch 523 can ramp overtop and past the first latch 521 when the actuator 501 is moved in the proximal direction 529. In some aspects, the first latch 521 can further comprise a first vertical planar surface 526 and the second latch 523 can further comprise a second vertical planar surface 528. The first vertical planar surface 526 and the second vertical planar surface 528 can be configured to interface with one another when the locking device 513 is in the locked position 603. For example, because the first vertical planar surface 526 and the second vertical planar surface 528 are both vertical and parallel to one another, when the locking device 513 is in the locked position 603, the second latch 523 will be prevented from moving in the distal direction 601 overtop the first latch 521 due to the verticality of the first vertical planar surface 526 and the second vertical planar surface 528. In other aspects, the locking device 513 is not limited to the above-described, but may be any other suitable locking device to prevent movement of the actuator 501. The operation of the locking device 513 will be described in more detail hereinafter.

[0064] In aspects, with particular reference to FIGS. 4 and 7, the distal end portion 205 of the base 201 can comprise a nose 433. In some aspects, a distal end of the distal end portion 205 of the base 201 can comprise a distal tip 435 of the nose 433. As shown, in some embodiments, the distal tip 435 of the nose 433 can be distally spaced in the distal direction from a distal end 406 of the pivot arm 401. For example, the distal tip 435 of the nose 433 can be distally spaced from the distal end 406 of the pivot arm 401 in the distal direction by a distance within a range from 0 mm to about 5 mm. It should be realized that the distance the distal tip 435 of the nose 433 can be spaced from the distal end 406 of the pivot arm 401 is not limited to the range describe above and is merely exemplary. Accordingly, the nose 433 can work with any other number of suitable ranges.

[0065] Similarly to that described previously, the cone 433 can comprise one or more radiopaque markers (e.g., one radiopaque marker, two radiopaque markers, three radiopaque markers, etc.). For example, the one or more radiopaque markers can optionally be disposed along a portion of the cone 433. In some examples, the one or more radiopaque markers can be disposed on an upper portion of the cone 433, such as for example, along a sloped upper surface of the cone 433. Any radiopaque materialmay be utilized, such as though described previously. In this way, the cone 433 will be able to be located by a clinician (e.g., a surgeon) when maneuvering the cavitation device 200 within the vasculature of a patient. For example, a clinician can utilize fluoroscopic imaging of the one or more radiopaque markers while maneuvering the cavitation device within the vasculature of a patient. It should be further realized that any other suitable component of the cavitation device 200 described previously and / or hereinafter can be provided with one or more radiopaque markers to facilitate a clinician in locating the component with the one or more radiopaque markers within a patient’s vasculature as described.

[0066] An exemplary operation of the actuator 501 will now be described with reference to FIGS. 4-7 to arm the cavitation device 200 by pivoting the pivot arm 401 from the closed position 407 to the open position 701. As shown in FIG. 5, a second end of the first tether 503 is coupled to the actuator 501. As the actuator 501 is moved (i.e., pushed, pulled, and / or slid) in the proximal direction 529, tension in the first tether 503 is increased. In some examples, a clinician can use their hand(s) to move the actuator 501 in the proximal direction 529 during operation. In other examples (explained above), the actuator 501 can be moved in the proximal direction 529 by an electric motor activated by the clinician.

[0067] When the second latch 523 of the actuator 501 makes contact with the first latch 521 of the locking device 513, the biasing device 519 will begin to compress, thereby pushing the first latch 521 radially inward towards a center of the handle device 500. As a result of the first rounded surface 522 of the first latch 521, the second rounded surface 524 of the second latch 523, and the biasing device 519 compressing, the second latch 523 will ramp overtop of the first latch 521 until the actuator 501 has been stopped in the proximal direction 529, such as for example reaching an end of the groove 507.

[0068] With reference to FIG. 6, at this point, the second latch 523 will have fully cleared the first latch 521 and the biasing device 519 will expand back to its uncompressed configuration. The first latch 521 will also be restored to its original starting position (i.e., will be biased radially outward with respect to the handle device 500). As a result, the first vertical planar surface 526 and the second vertical planar surface 528 will interface and contact one another to prevent the second latch 523 from moving back in the distal direction 601 as a result of the tension in the first tether 503. As shown in FIG. 6, the actuator 501 will now be the locked position 603.

[0069] During the movement of the actuator 501 in the proximal direction 529, and as a result of the increased tension in the first tether 503, the pivot arm 401 will begin to rotate to the open position 701 (indicated by rotation arrow 431, shown in FIG. 4). When the actuator 501 has reached the locked position 603, the pivot arm 401 will be in the open position 701, as shown in FIG. 7.

[0070] Meanwhile, as illustrated in FIG. 5, prior to moving the actuator 501 in the proximal direction 529, the spring 533 and the second tether 531 remain in an unstretched configuration (i.e., there is less tension in the spring 533 and the second tether 531, as opposed to when the pivot arm 401 is moving to the open position 701). As the actuator 501 is moved in the proximal direction 529, the spring 533 and / or the second tether 531 begin to stretch (indicated by arrow 605 in FIG. 6). Consequently, the tension in the spring 533 and the second tether 531 are increased and configured to bias the pivot arm 401 to the closed position 407 (i.e., the pivot arm 401 is biased to the closed position 407 while the pivot arm 401 is being rotated to the open position 701). Thus, while the actuator 501 is in the locked position 603 described above, the spring 533 and the second tether 531 are in high tension. The term “high tension” is utilized herein to refer to tension that will act on the pivot arm 401 to snap the pivot arm 401 from the open position to the closed position to generate the pressure pulse wave 1101 once the actuator is unlocked.

[0071] Now viewing FIG. 6, the actuator 501 is shown in the locked position 603, where the spring 533 and the second tether 531 are in tension. Next, in order to unlock the actuator 501 from the locked position 603, the release button 517 can be pressed. For example, a clinician can press the release button 517 to apply a pressing force 607 to unlock the actuator 501. When the pressing force 607 (i.e., by a clinician) is applied to the release button 517, the lever 515 is pushed radially inward with respect to the handle device 500, to transfer the pressing force 607 from to the release button 517 to the biasing device 519. The biasing device 519 is then compressed as a result of the pressing force 607. The first latch 521 will then be displaced radially inward, thereby releasing the second latch 523 from the first latch 521. As shown in FIG. 7, due to the tension in the spring 533 (shown generally by a tension arrow 703 in FIG. 7), the pivot arm 401 will be snapped to the closed position 407 (indicated by rotational arrow 705 in FIG. 7) to generate the pressure pulse wave 1101.

[0072] Exemplary shafts of the disclosure can comprise at least one inner shaft and / or at least one outer shaft although a single shaft may be provided in further embodiments.For example, FIG. 8 is a cross-sectional view illustrating an inner shaft 801 and an outer shaft 803. The inner shaft 801 can comprise a first lumen 805 through which the first tether 503 is slidably inserted for coupling the actuator 501 to the pivot arm 401, and a second lumen 807 through which the second tether 531 is slidably inserted for coupling the second tether 531 to the pivot arm 401.

[0073] In some aspects, the inner shaft 801 can be configured to rotate the cavitation device 200 about a longitudinal axis of the inner shaft 801. For example, the inner shaft 801 can be configured to rotate 360 degrees about the longitudinal axis of the inner shaft 801 such that the inner shaft 801 rotates the cavitation device 200 relative to the outer shaft 803 (e.g., by 360 degrees).

[0074] In aspects, the outer shaft 803 can be configured to flex in one or more planes to move the cavitation device 200. For example, the outer shaft 803 and the inner shaft 801 can comprise a bending section (not shown) to enable the inner shaft 801 and the outer shaft 803 to flex in one or more planes, thereby allowing the cavitation device 200 to move to a desired orientation. The term “one or more planes” as used herein, should be construed to mean the shaft 800 can bend in any number of planes and thus may assume many orientations, such as for example bending in a range of 0 to 90 degrees in any plane. The term “plane” can be construed in view of FIG. 1, where the plane for the purposes of this application can be viewed based on the orientation of page itself, for example, the plane can be described as a plane parallel to the drawing sheet, perpendicular to the drawing sheet, and any other plane contemplated therebetween. It should be realized that viewing the term “one or more planes” in view of the drawing sheet is exemplary and a person having ordinary skill in the art would realize that such planes may be described relative to the environment in which the device is utilized, and thus, is not meant to be limiting.

[0075] In aspects, the outer shaft 803 can be coupled to the cavitation device 200 by a plurality of movement tethers configured to facilitate the movement of the cavitation device 200 by selectively adjusting the tension in one or more of the plurality of movement tethers. For example, applying tension to one or more of the plurality of movement tethers will bend the shaft 800 in one or more planes at a bending section of the shaft to move the cavitation device 200 to the desired orientation. As shown, the plurality of movement tethers comprise three movement tethers although one, two or more than three movement tethers may be provided in further embodiments.

[0076] As shown in FIGS. 10-12, the transcatheter device 100 can comprises an embolic protection device 1000 retained within a sheath 1001 and configured to expand when the sheath 1001 is retracted in a proximal direction 529. In some aspects, the embolic protection device 1000 can comprises a self-expandable nitinol material. The term “self-expandable” refers to the materials ability to return to its normal, original uncompressed state. For example, when the sheath 1001 is retracted to expose the embolic protection device 1000, the embolic protection device 1000 will radially expand to its normal, expanded state. As shown, the embolic protection device 1000 can comprise a mesh of self-expanding material (e.g., nitinol). Although not shown, other embolic protection devices that are not self-expandable may be used in further embodiments. For example, an inflatable balloon can be utilized in expanding another embodiment of an embolic protection device.

[0077] Generally, removing calcification from a patient with the transcatheter device 100 can comprise delivering a cavitation device 200 to a target treatment site 903, orienting the cavitation device 200 to be directed at a calcium deposit 1003, and pivoting a pivot arm 401 of the cavitation device 200 from an open position 701 to a closed position 407, wherein a pressure pulse wave 1101 is generated within a fluid that targets a portion of the calcium deposit 1003. More specifically with reference to FIG. 9, an exemplary transcatheter device 100 entering a lumen 900 of a patient is shown. For example, the lumen 900 can include the right ventricle, the left ventricle, the right atrium and / or any other lumens within the patient. As illustrated, the method can comprise delivering a cavitation device 200 to a target treatment site 903. In some examples, the target treatment site 903 can be within a heart valve of the patient, such as for instance, the aortic valve, the pulmonic valve, the tricuspid valve, and / or the mitral valve. The target treatment site 903 is not limited to heart valves. It will be appreciated that the method described hereinafter can be employed to remove calcification from other target treatment sites within a patient as well. In some aspects, the target treatment site 903 can comprise the fluid. For example, the target treatment site 903 can comprise blood, such as for example, when the cavitation device 200 is delivered within a heart valve of a patient. In some examples, a clinician can guide the transcatheter device 100 to the target treatment site 903 in a patient (e.g., through the femoral artery) utilizing a handle device 500.

[0078] FIG. 10 illustrates the step of orienting the cavitation device 200 to be directed at the calcium deposit 1003. For example, orienting the cavitation device 200 cancomprise positioning the distal end 406 of the pivot arm 401 a predetermined distance from the calcium deposit 1003 in the closed position 407. In some aspects, the step of orienting the cavitation device 200 can further comprise locating one or more radiopaque markers disposed on one or more portions of the cavitation device 200 to determine a position of the cavitation device 200 relative to the target treatment site 903. In some aspects, the one or more radiopaque markers can be located utilizing fluoroscopic imaging. In some aspects, the one or more radiopaque markers can be positioned on the pivot arm 401, and the method can further comprise locating the one or more radiopaque markers positioned on the pivot arm 401 to determine a position of the pivot arm 401 relative to the target treatment site 903. Additionally and / or alternatively, the one or more radiopaque markers can be positioned on the nose 433, and the method can further comprise locating the one or more radiopaque markers positioned on the nose 433 to determine a position of the nose 433 relative to the target treatment site 903. Additionally and / or alternatively, the one or more radiopaque markers can be positioned on the distal tip 435 of the cone 433, and the method can further comprise locating the one or more radiopaque markers positioned on the distal tip 435 of the nose 433 to determine a position of the distal tip 435 relative to the target treatment site 903. In further aspects, after locating the one or more radiopaque markers, the method can then comprise the step of positioning the distal end 406 of the pivot arm 401 a predetermined distance from the calcium deposit 1003 in the closed position 407 relative to the one or more radiopaque markers. In some examples, the predetermined distance can be within a range of from 0 mm to about 5 mm. In aspects, positioning the distal end 406 of the pivot arm 401 the predetermined distance from the calcium deposit 1003 in the closed position 407 comprises engaging the distal tip 435 of the nose 433 of the cavitation device 200 with at least one of a leaflet 1005 and / or the portion of the calcium deposit 1003.

[0079] In some aspects, as shown in FIG. 10, the method can further comprise arming the transcatheter device 100 by moving the pivot arm 401 from the closed position 407 to the open position 701 by a first tether 503 coupled to the pivot arm 401. For example, the clinician can slide (i.e., pull) the first tether 503 in a proximal direction 529, thereby moving (i.e., rotating) the pivot arm 401 from the closed position 407 to the open position 701 (shown in dashed lines in FIG. 10). In some examples, the first tether can be coupled to an actuator in which a clinician can activate the actuator to arm the transcatheter device 100. In some aspects, arming the transcatheter device 100comprises increasing a tension in a second tether 531 coupled to the pivot arm 401 that biases the pivot arm 401 from the open position 701 to the closed position 407. In some examples, tension can be stored in a spring 533 that applies the tension to the second tether 531. More specifically, the second tether 531 and the spring 533 can be coupled together, where the spring 533 can be a tension spring that biases (i.e., pulls) the pivot arm 401 to the closed position 407 by applying a pulling force to a lower portion 429 of the pivot arm 401. In some examples, as a clinician slides the first tether 503 in the proximal direction 529, the second tether 531 and the spring 533 will increase in tension to bias the pivot arm 401 to the closed position 407.

[0080] FIG. 11 shows the step of pivoting the pivot arm 401 of the cavitation device 200 to snap shut from the open position 701 to the closed position 407 to generate the pressure pulse wave 1101 within the fluid that targets the portion of the calcium deposit 1003. In some aspects, pivoting the pivot arm 401 from the open position 701 to the closed position 407 forces the fluid through a chamber 419 to generate the pressure pulse wave 1101. For example, as shown, the pressure pulse wave 1101 is exiting the chamber 419 and is being directed at the calcium deposit 1003 when the pivot arm 401 is moved from the open position 701 to the closed position 407. When the pressure pulse wave 1101 reaches the calcium deposit 1003, the pressure pulse wave 1101 will make contact with the calcium deposit 1003 to remove a portion 1203 of the calcium deposit 1003. In order to further illustrate the principles of operation of the pressure pulse wave 1101 , as the pivot arm 401 of the cavitation device 200 snaps shut from the open position 701 to the closed position 407, a high speed jet of fluid (e.g., blood) is displaced through the chamber 419. In this way , due to the velocity at which the pivot arm 401 snaps shut from the open position 701 to the closed position 407, the localized pressure within the stream of fluid (e.g., the pressure of blood displaced by the pivot arm 401) exiting the chamber drops below the localized pressure of the surrounding fluid (e.g., the surrounding blood not displaced by the pivot arm 401), thereby forming vapor regions (e.g., also known as cavities) within the stream of fluid. As a result of the localized depressurization and the formation of vapor regions within the stream of fluid, a bubble is formed, which is known to someone skilled in the art as a cavitation bubble. For example, as the fluid exits the chamber 419, the fluid is vaporized (e.g., the blood is vaporized) as a result of the local pressure being below saturation pressure. When the local pressure of the surrounding fluid increases (e.g., is above the vapor pressure), the cavitation bubble collapses on itself. Consequently, the collapse of the cavitation bubbleresults in the formation of a shock wave (e.g., a pressure pulse wave) to be emitted causing high pressure loads on surround structure (e.g., a calcium deposit). These shock waves or pressure pulse waves can then be directed (e.g., towards the calcium deposit 1003) to utilize the high pressure loads to remove the calcium deposit 1003.

[0081] FIG. 12 illustrates the portion of the calcium deposit 1003 that has been removed by the pressure pulse wave 1101. In some aspects, the method can further comprise capturing the removed portion 1203. For example, capturing the removed portion 1203 of the calcium deposit can comprise passing fluid entrained with the removed portion 1203 through a fdter 1000. In some aspects, the fdter 1000 can comprise nitinol. As a non-limiting example, if the cavitation device 200 is utilized to remove calcification from a heart valve, as the blood flows in a downstream direction 1205, the removed portion 1203 will become entrained within the blood and also flow in the downstream direction 1205. As the blood passes through the filter 1000, the removed portion 1203 will become captured within the filter 1000.

[0082] It will be appreciated that the method described above can be repeated to remove more than one different calcium deposit 1003. Furthermore, the method may be repeated as necessary to remove a calcium deposit 1003 that is particularly resilient. For example, if the calcium deposit 1003 is particularly large (i.e., difficult to remove), the method described above can be utilized sequentially as many times as is required to remove the calcium deposit 1003.

[0083] FIG. 13, illustrates the transcatheter device 100 after the calcium deposit 1003 has been fully remove and no additional calcium deposits require removal. As show, the removed portion 1203 of the calcium deposit can be removed from the patient along with the transcatheter device 100. For example, a clinician can slide an actuator in the distal direction 601 that is coupled to the sheath 1001 where a distal end 1302 of the sheath 1001 can shift in distal direction 1301 relative to the cavitation device 200 to apply a radially inward force to an embolic protection device 1000. The radially inward force can recapture the embolic protection device 1000 within the sheath 1001.

[0084] In another exemplary method of removing calcification from a patient using a transcatheter device 100, the cavitation device 200 can be delivered to the target treatment site 903, orienting the cavitation device 200 to be directed at a calcium deposit 1003, and activating the actuator 501 to move the pivot arm 401 from the open position 701 to the closed position 407, wherein a pressure pulse wave 1101 is generated within a fluid that targets a portion of the calcium deposit 1003. More specifically, FIG. 9shows the exemplary transcatheter device 100 entering a lumen 900 of a patient. For example, the lumen 900 can include the right ventricle, the left ventricle, the right atrium and / or any other lumens within the patient. As illustrated, the method can comprise delivering a cavitation device 200 to a target treatment site 903. In some examples, the target treatment site 903 can be within a heart valve of the patient, such as for instance, the aortic valve, the pulmonic valve, the tricuspid valve, and / or the mitral valve. The target treatment site 903 is not limited to heart valves. It will be appreciated that the method described hereinafter can be employed to remove calcification from other target treatment sites within a patient as well. In some examples, a clinician can guide the transcatheter device 100 to the target treatment site 903 in a patient (e.g., through the femoral artery) utilizing a handle device 500.

[0085] After the transcatheter device 100 has reached the target treatment site 903, FIG. 10 illustrates the step of orienting the cavitation device 200 to be directed at the calcium deposit 1003. In aspects, the orienting the shaft 800 can comprise rotating the shaft 800 about a longitudinal axis and / or flexing the shaft 800 in one or more planes. For example, a clinician can activate an actuator that rotates (e.g., 360 degrees) the shaft 800 to facilitate directing the cavitation device 200 at the calcium deposit 1003. In some examples, the clinician can activate an actuator that bends the shaft 800, in one or more planes to facilitate directing the cavitation device 200 at the calcium deposit 1003.

[0086] Further illustrated in FIG. 10, the method further comprises arming the transcatheter device 100 by moving the pivot arm 401 from the closed position 407 to the open position 701 by a first tether 503 coupled to the pivot arm 401. For example, a clinician can pull the first tether 503 in a proximal direction 529 to move the pivot arm 401 from the closed position 407 to the open position 701. In some examples, the first tether 503 can be connected to an actuator and a clinician can activate the actuator to move the pivot arm 401 from the closed position 407 to the open position 701. In aspects, arming the transcatheter device 100 increases a tension in a second tether 531 coupled to the pivot arm 401 that biases the pivot arm 401 from the open position 701 to the closed position 407. In some aspects, tension is stored in a spring 533 that applies the tension to the second tether 531. In some examples, as a clinician moves the first tether 503 in the proximal direction 529, tension in the spring 533 and / or the second tether 531 increases.

[0087] Still viewing FIG. 10, in aspects, the distal opening 209 of the distal end portion 205 of the base 201 comprises a nose 433, wherein a distal tip 435 of the nose 433 isdistally spaced from a distal end 406 of the pivot arm 401 in the closed position, and wherein, before activating the actuator 501, the method further comprising engaging the distal tip 435 of the nose 433 with at least one of a leaflet 1005 and / or the portion of the calcium deposit 1003.

[0088] Turning to FIG. 11, the step of activating the actuator 501 to snap the pivot arm 401 shut from the open position 701 to the closed position 407 is shown. For example, when the actuator 501 pivots the pivot arm 401 from the open position 701 to the closed position 407 the pressure pulse wave 1101 is formed. In some aspects, the actuator 501 further comprises a first tether 503 coupled to the pivot arm 401. The method can further comprise releasing a tension in the first tether 503 to move the pivot arm 401 from the open position 701 to the closed position 407. In some aspects, the method further comprises a first tether 503 coupled to the actuator 501 and a spring 533 to bias the pivot arm 401 to the closed position 407. In aspects, the method further comprises sliding the actuator 501 in a proximal direction 529 to apply tension to the first tether 503 to move the pivot arm 401 to the open position 701. The method can further comprise locking the actuator 501 to maintain tension in the first tether 503. Following this, the method can further comprise unlocking the actuator 501 to release tension in the first tether 503, whereby tension in the spring 533 snaps the pivot arm 401 to the closed position 407.

[0089] In aspects, the distal portion 405 of the pivot arm 401 comprises a plunger 409 comprising a contoured surface 411 that is configured to accommodate an ingress of a fluid. In aspects, when the pivot arm 401 is in the closed position 407, the plunger 409 forms a chamber 419 between the contoured surface 411 of the plunger 409 and an interior surface 421 of the channel 211. The method can further comprise activating the actuator 501 to move the pivot arm 401 from the open position 701 to the closed position 407 to force the fluid through the gap 423 in the chamber 419 to generate the pressure pulse wave 1101. In some aspects, the method can further comprise filling the chamber 419 with a fluid. For example, the fluid comprises blood, such as for example, blood that resides within a patient’s heart.

[0090] FIG. 12, illustrates the transcatheter device 100 after the portion 1203 of the calcium deposit 1003 has been removed. In some aspects, the transcatheter device 100 further comprises the embolic protection device 1000, and the method further comprises deploying the embolic protection device 1000 in a downstream direction 1205 from the cavitation device 200 to capture the removed portion 1203 of the calciumdeposit 1003. For example, as shown in FIG. 10, the embolic protection device 1000 can be retained within a sheath 1001, and wherein deploying the embolic protection device 1000 further comprises retracting the sheath 1001 in a proximal direction 529 (indicated by arrow 1007 in FIG. 10). In some examples, the removed portion 1203 of the calcium deposit 1003 will become entrained within the blood and as the blood moves in the downstream direction 1205 the removed portion 1203 of the calcium deposit 1003 will be caught in the embolic protection device 1000. In some aspects, the embolic protection device 1000 can comprise a filter 1000 formed from nitinol configured to self-expand when the sheath 1001 is retracted.

[0091] FIG. 13, illustrates the transcatheter device 100 after the calcium deposit 1003 has been fully remove and no additional calcium deposits require removal. As show, the method can further comprise sliding the sheath 1001 in the distal direction 601 (indicated at the arrow 1301) to recapture the embolic protection device 1000 (shown in FIGS. 10-12). For example, a clinician can slide an actuator (not shown) in the distal direction 601 that is coupled to the sheath 1001 where a distal end 1302 of the sheath 1001 can apply a radially inward force to the embolic protection device 1000. The radially inward force can recapture the embolic protection device 1000 within the sheath 1001.

[0092] In accordance with the disclosure, non-limiting aspects of the disclosure will now be described. Various combinations of the aspects can be provided in accordance with the disclosure.

[0093] Aspect 1. A transcatheter device comprises a shaft comprising a proximal end and a distal end. The transcatheter device further comprises a handle device coupled to the proximal end of the shaft, wherein the handle device comprises an actuator. The transcatheter device further comprises a cavitation device coupled to the distal end of the shaft. The cavitation device comprises a base extending in a distal direction from a proximal end portion of the base to a distal end portion of the base. The base comprises an outer peripheral surface extending from the proximal end portion to a distal opening of the distal end portion. The base further comprises a channel extending in the distal direction and open to the outer peripheral surface and the distal opening of the base. The cavitation device further comprises a pivot arm comprising a proximal portion pivotally mounted to the base and configured to be pivoted between an open position and a closed position. The actuator is configured to be activated to move the pivot arm from the open position to the closed position.

[0094] Aspect 2. The transcatheter device of Aspect 1, wherein the distal portion of the pivot arm comprises a plunger comprising a contoured surface that is configured to face an interior surface of the channel in the closed position.

[0095] Aspect 3. The transcatheter device of Aspect 2, wherein the base and the plunger define a seated interface in the closed position.

[0096] Aspect 4. The transcatheter device of any one of Aspects 2-3, wherein the plunger forms a chamber between the contoured surface of the plunger and the interior surface of the channel in the closed position.

[0097] Aspect 5. The transcatheter device of any one of Aspects 1-4, wherein the actuator is further configured to pivot the pivot arm from the closed position to the open position.

[0098] Aspect 6. The transcatheter device of any one of Aspects 1-5, further comprising a pin pivotally mounting the proximal portion of the pivot arm to the base.

[0099] Aspect 7. The transcatheter device of any one of Aspects 1-6, wherein the actuator comprises a first tether coupled to the pivot arm, and a second tether coupled to the pivot arm. The first tether is configured to pivot the pivot arm from the closed position to the open position and the second tether is configured to bias the pivot arm from the open position to the closed position.

[0100] Aspect 8. The transcatheter device of Aspect 7, wherein the actuator further comprises a spring, wherein the spring and the second tether are configured to bias the pivot arm from the open position to the closed position.

[0101] Aspect 9. The transcatheter device of any one of Aspects 7-8, wherein the actuator is configured to place the first tether in tension by translating the actuator relative to a body of the handle device to pivot the pivot arm from the closed position to the open position with the first tether.

[0102] Aspect 10. The transcatheter device of Aspect 9, wherein the actuator further comprises a locking device configured to lock the actuator in a locked position relative to the body of the handle device to maintain tension in the first tether to maintain the pivot arm in the open position, and wherein the locking device is configured to be released from the locked position to snap the pivot arm to the closed position.

[0103] Aspect 11. The transcatheter device of any one of Aspects 7-10, wherein the shaft comprises an inner shaft and an outer shaft, and the inner shaft comprises at least one lumen slidably receiving the first tether and / or the second tether.

[0104] Aspect 12. The transcatheter device of Aspect 11, wherein the inner shaft is configured to rotate the cavitation device relative to the outer shaft.

[0105] Aspect 13. The transcatheter device of Aspect 12, wherein the inner shaft is configured to rotate the cavitation device 360 degrees relative to the outer shaft.

[0106] Aspect 14. The transcatheter device of any one of Aspects 11-13, wherein the outer shaft is configured to flex in one or more planes to move the cavitation device.

[0107] Aspect 15. The transcatheter device of Aspect 14, further comprising a plurality of movement tethers configured to facilitate movement of the cavitation device.

[0108] Aspect 16. The transcatheter device of any one of Aspects 1-15, wherein the distal end of the distal end portion of the base is distally spaced from a distal end of the pivot arm.

[0109] Aspect 17. The transcatheter device of Aspect 16, wherein the distal end of the distal end portion of the base is distally spaced from the distal end of the pivot arm by a distance within a range from 0 mm to about 5 mm.

[0110] Aspect 18. The transcatheter device of any one of Aspects 1-17, wherein the transcatheter device further comprises an embolic protection device retained within a sheath and configured to expand when the sheath is translated relative to the cavitation device.

[0111] Aspect 19. The transcatheter device of Aspect 18, wherein the embolic protection device comprises a self-expandable material.

[0112] Aspect 20. The transcatheter device of Aspect 19, wherein the self-expandable material comprises nitinol.

[0113] Aspect 21. A method of removing calcification from a patient using the transcatheter device of Aspect 1, the method comprising delivering the cavitation device to a target treatment site of the patient. The method further comprises orienting the cavitation device to target a calcium deposit, and activating the actuator to move the pivot arm from the open position to the closed position. A pressure pulse wave is generated within a fluid that removes a portion of the calcium deposit.

[0114] Aspect 22. The method of Aspect 21, wherein the actuator further comprises a first tether coupled to the pivot arm, and wherein activating the actuator further comprises releasing a tension in the first tether to snap the pivot arm from the open position to the closed position.

[0115] Aspect 23. The method of Aspect 22, wherein, prior to activating the actuator, further comprising arming the transcatheter device by moving the pivot arm from theclosed position to the open position, and locking the pivot arm in the open position wherein a tension in a first tether coupled to the pivot arm maintains the pivot arm in the open position.

[0116] Aspect 24. The method of Aspect 23, wherein arming the transcatheter device biases the pivot arm from the open position to the closed position with a second tether coupled to the pivot arm.

[0117] Aspect 25. The method of Aspect 24, wherein arming the transcatheter device stores potential energy in a spring that maintains a tension to the second tether that biases the pivot arm from the open position to the closed position.

[0118] Aspect 26. The method of any one of Aspects 21-25, further comprising capturing the portion of the calcium deposit with the transcatheter device.

[0119] Aspect 27. The method of Aspect 26, wherein capturing the portion of the calcium deposit comprises retracting a sheath to deploy an embolic protection device.

[0120] Aspect 28. The method of Aspect 27, wherein the embolic protection device comprises a filter formed from nitinol configured to self-expand when the sheath is retracted.

[0121] Aspect 29. The method of any one of Aspects 27-28, wherein capturing the portion of the calcium deposit further comprises extending the sheath to recapture the embolic protection device.

[0122] Aspect 30. The method of any one of Aspects 21-28, wherein orienting the cavitation device comprises rotating the shaft about a longitudinal axis and / or flexing the shaft in one or more planes.

[0123] Aspect 31. The method of any one of Aspects 21-30, further comprising engaging a distal end of the distal end portion of the base with at least one of a leaflet and / or the calcium deposit while activating the actuator.

[0124] Aspect 32. The method of any one of Aspects 21-31, wherein the pressure pulse wave is generated by forcing fluid through a gap between the pivot arm and the base.

[0125] Aspect 33. The method of any one of Aspects 21-32, wherein the fluid comprises blood.

[0126] Aspect 34. A method of removing calcification from a patient with a transcatheter device comprising delivering a cavitation device to a target treatment site of the patient. The method further comprises orienting the cavitation device to target a calcium deposit, and pivoting a pivot arm of the cavitation device from an open positionto a closed position. A pressure pulse wave is generated within a fluid that removes a portion of the calcium deposit.

[0127] Aspect 35. The method of Aspect 34, wherein the target treatment site comprises the fluid.

[0128] Aspect 36. The method of any one of Aspects 34-35, wherein pivoting the pivot arm comprises snapping the pivot arm from the open position to the closed position.

[0129] Aspect 37. The method of any one of Aspects 34-36, further comprising arming the transcatheter device by moving the pivot arm from the closed position to the open position.

[0130] Aspect 38. The method of Aspect 37, wherein, after arming the transcatheter device, the pivot arm is biased from the open position to the closed position.

[0131] Aspect 39. The method of any one of Aspects 34-38, further comprising capturing the removed portion of the calcium deposit with the transcatheter device.

[0132] Aspect 40. The method of Aspect 39, wherein capturing the removed portion of the calcium deposit comprises passing fluid entrained with the removed portion of the calcium deposit through a filter.

[0133] Aspect 41. The method of any one of Aspects 34-40, further comprising engaging the cavitation device with at least one of a leaflet and / or a portion of the calcium deposit while pivoting the pivot arm from the open position to the closed position.

[0134] Aspect 42. The method of any one of Aspects 34-41, wherein the pressure pulse wave is generated by forcing fluid through a gap between the pivot arm and a base of the cavitation device.

[0135] Aspect 43. The method of any one of Aspects 34-42, wherein the fluid comprises blood.

Claims

What is claimed is:

1. A transcatheter device (100) comprising: a shaft (800) comprising a proximal end (105) and a distal end (107); a handle device (500) coupled to the proximal end (105) of the shaft (800), wherein the handle device (500) comprises an actuator (501); and a cavitation device (200) coupled to the distal end (107) of the shaft (800), the cavitation device (200) comprising: a base (201) extending in a distal direction ()from a proximal end portion (203) of the base (201) to a distal end portion (205) of the base (201), the base (201) comprising an outer peripheral surface (207) extending from the proximal end portion (203) to a distal opening (209) of the distal end portion (205), and the base (201) further comprising a channel (211) extending in the distal direction and open to the outer peripheral surface (207) and the distal opening (209) of the base (201); and a pivot arm (401) comprising a proximal portion (403) pivotally mounted to the base (201) and configured to be pivoted between an open position (701) and a closed position (407), wherein the actuator (501) is configured to be activated to move the pivot arm (401) from the open position (701) to the closed position (407).

2. The transcatheter device (100) of claim 1, wherein the actuator (501) comprises a first tether (503) coupled to the pivot arm (401), and a second tether (531) coupled to the pivot arm (401), wherein the first tether (503) is configured to pivot the pivot arm (401) from the closed position (407) to the open position (701) and the second tether (531) is configured to bias the pivot arm (401) from the open position (701) to the closed position (407).

3. The transcatheter device (100) of claim 2, wherein the actuator (501) further comprises a spring (533), wherein the spring (533) and the second tether (531) are configured to bias the pivot arm (401) from the open position (701) to the closed position (407).

4. The transcatheter device (100) of any one of claims 2-3, wherein the actuator (501) is configured to place the first tether (503) in tension by translating the actuator (501) relative to a body of the handle device (500) to pivot the pivot arm (401) from the closed position (407) to the open position (701) with the first tether (503).

5. The transcatheter device (100) of claim 4, wherein the actuator (501) further comprises a locking device (513) configured to lock the actuator (501) in a locked position (603) relative to the body of the handle device (500) to maintain tension in the first tether (503) to maintain the pivot arm (401) in the open position (701), and wherein the locking device (513) is configured to be released from the locked position (603) to snap the pivot arm (401) to the closed position (407).

6. The transcatheter device (100) of any one of claims 2-5, wherein the shaft(800) comprises an inner shaft (801) and an outer shaft (803), and the inner shaft(801) comprises at least one lumen (805, 807) slidably receiving the first tether (503) and / or the second tether (531).

7. The transcatheter device (100) of claim 6, wherein the inner shaft (801) is configured to rotate the cavitation device (200) relative to the outer shaft (803).

8. The transcatheter device (100) of any one of claims 6-7, wherein the outer shaft (803) is configured to flex in one or more planes to move the cavitation device (200).

9. The transcatheter device (100) of any one of claims 1-8, wherein the distal end (435) of the distal end portion (205) of the base (201) is distally spaced from a distal end (406) of the pivot arm (401).

10. The transcatheter device (100) of any one of claims 1-9, wherein the transcatheter device (100) further comprises an embolic protection device (1000) retained within a sheath (1001) and configured to expand when the sheath (1001) is translated relative to the cavitation device (200).

11. A method of removing calcification from a patient with a transcatheter device (100) comprising: delivering a cavitation device (200) to a target treatment site (903) of the patient; orienting the cavitation device (200) to target a calcium deposit (1003); and pivoting a pivot arm (401) of the cavitation device (200) from an open position (701) to a closed position (407), wherein a pressure pulse wave (1101) is generated within a fluid that removes a portion (1203) of the calcium deposit (1003).

12. The method of any one of claims 11, wherein pivoting the pivot arm (401) comprises snapping the pivot arm (401) from the open position (701) to the closed position (407).

13. The method of any one of claims 11-12, further comprising arming the transcatheter device (100) by moving the pivot arm (401) from the closed position (407) to the open position (701).

14. The method of any one of claims 11-13, further comprising capturing the removed portion (1203) of the calcium deposit (1003) with the transcatheter device (100).

15. The method of any one of claims 11-14, further comprising engaging the cavitation device (200) with at least one of a leaflet (1005) and / or a portion (1203) of the calcium deposit (1003) while pivoting the pivot arm (401) from the open position (701) to the closed position (407).

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