Endovascular ablation catheter with energy delivery member and valve - Patent Application 20070122997

Abstract

A catheter for endoluminal ablation includes a first lumen and an energy delivery member supported by the catheter body, the energy delivery member including a passageway, a valve disposed in the passageway, and an energy emitter configured to deliver energy to the target tissue. A method for performing endoluminal ablation is also disclosed.

Description

[Technical Field]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application is a continuation-in-part of application Ser. No. 16 / 875,122, filed May 15, 2020, which is a continuation-in-part of application Ser. No. 16 / 870,045, filed May 8, 2020, now U.S. Patent No. 11,006,996. The entire contents of each of these applications are incorporated herein by reference.

[0002] The present invention relates generally to catheters placed in minimally invasive procedures, and more particularly to catheters for endovascular ablation having an expandable structure with an energy emitter and a valve. [Background technology]

[0003] The prior art teaches the use of devices in conjunction with medical procedures to control blood flow in blood vessels. One of the most common is the balloon catheter. Balloon catheters, as taught in the prior art, can be used to achieve isolation of a body part from its blood supply because the balloon is inflated (expanded) to occlude the vascular space and block blood flow.

[0004] One problem associated with the use of balloons is that while control of blood flow in a portion of a blood vessel is achieved, including blocking the blood supply to the target site, blood flow to other areas near the target site is completely blocked. This drawback may be tolerable for a short period of time because when one blood vessel is blocked, the body typically increases blood flow in other, essentially parallel, vessels. However, such blockage of blood flow becomes problematic when used over an extended period of time. Complex medical procedures cannot be accomplished in such a short period of time, resulting in damage to other areas or requiring multiple procedures at the same target site. There is a need for an instrument for better control of blood flow during surgical procedures.

[0005] Additionally, most current bypass catheters are designed to be surgically implanted, which is impractical for immediate relief of progressive ischemia caused by sudden occlusion of a blood vessel, such as by a thrombus or embolus.

[0006] Various instruments are known for performing thrombectomy, i.e., the removal of blood clots from blood vessels. These include, for example, mechanical thrombectomy instruments with rotating elements that break up the clot, instruments that deliver thrombolytic agents that dissolve the clot, instruments that deliver vibrational energy in the form of continuous or pulsatile waves, etc. However, these instruments do not adequately control blood flow during the procedure. Furthermore, these procedures can often be lengthy and very often do not provide immediate restoration of flow to the ischemic area. Summary of the Invention [Problem to be solved by the invention]

[0007] It would be advantageous to control blood flow during the removal or treatment of a clot or other obstruction, or the removal or softening of calcification. This would be particularly advantageous in relatively long procedures, such as the use of thrombolytic agents, where the clot is dissolved over time by infusion of a lytic agent to provide immediate and continuous reperfusion. It would be even more advantageous to provide immediate restoration of downstream blood flow, allowing time for improvement of the obstruction while halting further progression of ischemic injury to the affected vascular territory. None of the current devices accomplish this. [Means for solving the problem]

[0008] The present invention overcomes the problems and drawbacks of the prior art. The present invention provides an improved catheter and method for use in the body's vascular system, eliminating the problem of complete blood blockage that can result in ischemia and permanent damage if not rapidly reversed. That is, the present invention is deployed to address clots or other obstructions in arteries or veins that are causing ischemia or cardiac compression due to lack of flow.

[0009] Additionally, the present invention provides, in some embodiments, improved catheters and methods of use for intracavitary lithotripsy and, in some applications, for softening the calcification of highly calcified valves, such as heart valves.

[0010] In some aspects, the present invention provides a bypass catheter that is placed in the body temporarily, i.e., during a surgical procedure, or for a period of time, with a distal opening (hole) and a more proximal intravascular opening (hole) that allows blood flow from an area proximal to an area distal to the clot during a clot treatment procedure. Various embodiments of bypass catheters are disclosed herein, including various devices for treating / removing clots. In some embodiments, the catheter also includes a structure that limits retrograde blood flow in the catheter to enhance the reperfusion function of the catheter. In some embodiments, the catheter includes a filter in the distal portion that captures or blocks particles.

[0011] In some embodiments, the present invention includes temporary bypass balloon equipped catheters, difficult-to-access single-lumen support catheters, and rotary thrombectomy devices for irrigation and aspiration, as disclosed in application Ser. No. 15 / 732,397 (Temporary Bypass Balloon Catheters), Ser. Nos. 15 / 258,877, 15 / 538,898, and 15 / 731,478 (Rotary Isolators, Irrigation Microcatheters for Thrombectomy), and other Walzman single-lumen support disclosures, and the present invention provides, in embodiments, improvements thereon.

[0012] The devices of the present invention can be positioned so that at least one or more proximal holes, e.g., one or more side holes, of the device are disposed on one side of the arterial or venous mass / occlusion, and a more distal hole(s), e.g., a distal end hole, of the device is disposed on the opposite side of the arterial or venous mass / occlusion. Once the device is positioned in the desired vascular region, the bypass elements of the device allow for temporary diversion of flow in the catheter, for example, in the first or distal segment of the catheter as described below.

[0013] In some embodiments, backflow limiting structures are provided to prevent backflow of blood into the catheter, i.e., into the segment (region) of the catheter proximal to the side holes. Various embodiments of such structures are disclosed herein, including valves that provide one-way (distal) flow, small (reduced) proximal diameter, or attachment to pressurized fluid lines, or combinations of the above. These are discussed in more detail below.

[0014] Also, in some embodiments, in addition to or instead of a lumen for delivering fluid to the balloon for inflation, which may extend through or substantially through the wall of the catheter, the catheter of the present invention may have an additional lumen extending through or substantially through the wall of the intravascular segment of the catheter, which delivers fluid to the mass between the side hole and the end hole via at least one perforation communicating with the inside of the blood vessel. In this way, an effective temporary diversion of flow within the catheter is provided, allowing delivery of a lytic drug or other such agent to the mass, while allowing time for the directly administered agent to disrupt and dissolve the mass, temporarily avoiding progressive ischemic tissue damage.

[0015] In some embodiments, a balloon (or other anchoring structure) is provided on the outer diameter (outer wall) of the catheter, and the catheter may include an additional lumen in the wall or substantially in the wall of the intravascular segment of the catheter for inflation and deflation of the balloon.

[0016] Additionally, in some embodiments, mechanical clot removal structures may be provided to break up the clot, such as the side loops described below, which may macerate the clot when rotated.

[0017] In some embodiments, suction is also applied to the catheter, which may allow suction through the side holes and / or through the end holes. If suction is desired only through the end holes, the side holes can be drawn into the sheath or otherwise covered as described below, so that the side holes are closed and no suction is applied at the side holes, and all suction force is at the end holes. Alternatively, an active control valve may be provided to close off the side holes.

[0018] A significant advantage of the device of the present invention is that it allows for the rapid restoration of temporary blood flow through the blockage, avoiding ischemic injury and immediately restoring some flow beyond the clot. This allows additional time for the clot to be removed or dissolved while allowing flow to the tissue at risk. Additionally, in cases of large pulmonary emboli, the lack of outflow from the right side of the heart creates the additional problem of cardiac compression. The temporary bypass catheter described herein can also help relieve such cardiac compression by allowing outflow from the right heart past the clot when a large pulmonary embolus is present in the main pulmonary artery.

[0019] According to one aspect of the present invention, a surgical device (instrument) for treating a blood clot or other obstruction in a patient's vein is provided, comprising an elongate member, preferably tubular, having an outer wall, a first opening (hole) in a distal portion, and a second opening (hole) spaced proximally from the distal hole. The second hole is preferably located on a lateral side of the outer wall. A first lumen is provided in the elongate member for blood flow through the proximal second hole and the first lumen and out the distal first end hole to maintain blood flow during clot treatment. In some embodiments, the first lumen is a single, primary central lumen.

[0020] In some embodiments, at least one perforation can be disposed between the first and second perforations. A second lumen in the wall, substantially in the wall, or in the primary lumen of the intravascular segment communicates with the at least one perforation. The second lumen forms a conduit for infusion of a fluid through the at least one perforation into the vein to treat the clot, and upon infusion of a fluid to treat the clot, blood flows into the second perforation disposed proximal to the clot and exits through the first perforation distal to the clot.

[0021] In some embodiments, at least one additional third proximal end port is provided, which is fitted with an external termination device and remains outside the patient's body at all times, and to which suction can optionally be applied when desired to remove clots and debris from the vessel.

[0022] In some embodiments, at least one energy-emitting element is disposed on the elongate member, and in some embodiments, these are disposed within or substantially within the wall of the elongate member to emit energy that assists in the fragmentation and removal of the clot. In some embodiments, the energy-emitting element is disposed between the first and second bores of the catheter. In some embodiments, the energy-emitting element comprises an ultrasound-emitting element that enhances the flow or mixing of a fluid (medicine) injected from the catheter into or adjacent to the clot. In some embodiments, the ultrasound emission of the emitting element is synchronized with the timing of fluid delivery. In some embodiments, the energy can directly fragment large clots. In some embodiments, the energy can serve to fragment, soften, and dissolve calcifications or other hardened material. In some embodiments, a cooling element can be present. In some embodiments, a heating element can be present.

[0023] In some embodiments, at least one connector is provided to connect the energy emitter to an energy source for application of energy to a clot or other obstruction to aid in treatment, e.g., clot removal / dissolution. In some embodiments, the at least one connector is configured to connect the device to an ultrasound energy source. In some embodiments, the energy-emitting element extends into the wall of the catheter. In some embodiments, the energy-emitting element extends over at least a portion of the surface of the catheter. In some embodiments, the energy-emitting element may be incorporated into at least one balloon extending from the catheter. Such embodiments may be of particular use in intravascular ablation of cardiac valves or intracranial vessels, where prolonged balloon inflation for optimal contact and treatment time may not be acceptable without bypass elements that allow blood outflow from the heart and perfusion of cerebrovascular territories, respectively.

[0024] The above energy sources and energy emitters may also be utilized in the inflatable torus balloon disclosed in U.S. Patent No. 10,328,246, the entire contents of which are incorporated herein by reference. Such a device may be used during valvulolysis while allowing blood to escape from the heart through the central hole of the torus balloon during prolonged balloon inflation for prolonged contact with the valve, or similarly, allowing continuous blood flow in the vessel during vascular use.

[0025] In some embodiments, the device includes a rotatable maceration element disposed between the first and second holes, the maceration element being rotatable to pulverize the clot and other intravascular debris and obstructions.

[0026] In some embodiments, the device includes a sheath disposed over the elongate member, the elongate member and the sheath being relatively movable to selectively cover and expose side holes, the covering of the side holes restricting blood flow through the side holes. In some embodiments, the covering of the holes completely prevents fluid flow through the side holes. The covering of the side holes may also be used to reverse blood flow, so that blood flows proximally within the catheter lumen. Suction may be applied to the lumen to assist or induce such reverse flow.

[0027] In some embodiments, the device includes features that limit retrograde blood flow within the catheter, such as a valve or reduced diameter region for the first lumen, and in some embodiments, connecting pressurized fluid to the catheter at a proximal region can limit retrograde blood flow within the catheter.

[0028] It should be noted that in some embodiments where additional lumens are provided passing through the intravascular segment of the elongate body, the device is divided proximally, preferably outside the patient's body, into multiple lumens with independent outer walls, each terminating preferably at a proximal end aperture with an independent external termination device, such as a luer lock or a hub with a diaphragm.

[0029] According to another aspect of the present invention, a surgical device for treating a blood clot or other obstruction in a patient's blood vessel is provided, comprising an elongate member having an outer wall, a first opening (hole) at a distal portion, and a second opening (hole) spaced proximally from the distal opening. The second hole is preferably located on a side of the outer wall. A first lumen in the elongate member allows blood flow through the proximal hole and the lumen to exit the distal first hole to maintain blood flow during clot treatment. The device includes at least one energy emitter for emitting energy to the clot and a connector extending through the elongate member for connecting the energy emitter to an external energy source, such that when the bypass segment is positioned across the obstruction, blood flows into the second hole located proximal to the clot and out the first hole distal to the clot. Activation of the energy emitter may also be utilized at this location. Medication injection may also be utilized at this location.

[0030] In some embodiments, an energy emitter is disposed between the first and second holes. In some embodiments, the energy emitter emits ultrasonic energy at the clot. In some embodiments, a switch on the device is provided to activate the energy emitter. In some embodiments, a switch external to the device can activate the energy emitter.

[0031] In some embodiments, the device further comprises a second lumen for delivering an agent to the clot to dissolve the clot, which in some embodiments occurs during application of energy, for example, ultrasound energy.

[0032] According to another aspect of the present invention, there is provided a method of treating a blood clot or other obstruction in a patient's blood vessel, comprising: a) inserting into the blood vessel an instrument (device) having a first opening (hole) in a distal portion and a second opening (hole) spaced proximally from the distal hole, the second hole being located on a side of the outer wall; b) positioning the second hole of the instrument proximal to the clot and the first hole of the instrument distal to the clot to allow blood to flow through the proximal hole and the first lumen and out the distal hole to maintain blood flow while treating the clot; and c) applying energy to an energy emitter carried by the instrument to apply energy to the clot while blood is flowing in the lumen.

[0033] In some embodiments, the method further comprises injecting a thrombolytic solution through one or more perforations in the sidewall of the device.

[0034] In some embodiments, the method further includes selectively blocking blood flow at the second port and aspirating the mass from the first port via an external aspirator connected to a third port, i.e., a proximal end port that is external to the patient's body.

[0035] In some embodiments, the method further comprises injecting a thrombolytic solution through one or more perforations in the sidewall of the device.

[0036] In some embodiments, the method further comprises selectively preventing blood flow from the second hole during subsequent suction.

[0037] In some embodiments, the device includes at least one balloon on an exterior surface of the elongate member covering the first lumen, and in some embodiments, the device further includes at least one energy emitter on or supported / carried by the balloon for emitting energy.

[0038] In some embodiments, the method further includes using an instrument described herein to advance the instrument through the valve, inflating the balloon while blood is flowing through the first lumen in either direction required while the balloon is inflated, activating energy to shatter and soften the hardened material in and around the valve, and deactivating the energy to deflate the balloon.

[0039] In some embodiments, the hardened material is a mineralized material.

[0040] In some embodiments, the expansion, energy release, and contraction are repeated at least two times.

[0041] In some embodiments, the method includes a step of rotary maceration prior to aspiration.

[0042] According to another aspect of the present invention, a catheter is provided having a balloon supporting or attached to one or more energy emitters for treating an obstruction. The balloon has a passageway for blood flow. More specifically, the catheter may have a torus balloon for energy delivery and may have a single lumen therein that may allow for the passage of wires, fluid injection, and / or fluid for balloon inflation. In other embodiments, a torus balloon-equipped catheter for energy delivery may have a single catheter lumen dedicated to the balloon. In other embodiments, a torus balloon-equipped catheter for energy delivery may have more than one catheter lumen. A single balloon or multiple balloons may be provided. The balloons may be provided on any segment of the catheter. In some embodiments, an energy emitting element may extend on the outer surface of at least one balloon.

[0043] In accordance with another aspect of the present invention, there is provided a catheter for intraluminal lithotripsy having an outer wall, at least one torus balloon attached to the outer wall, a first lumen extending therethrough, at least one energy emitter attached to the balloon for emitting energy to pulverize limestone, and a connector extending within the catheter for connecting the energy emitter to an external energy source.

[0044] In some embodiments, the catheter allows for sustained inflation of at least one torus balloon within a heart valve without significantly impeding outflow from the heart. In some embodiments, the catheter allows for sustained inflation of at least one torus balloon within a blood vessel without significantly impeding blood flow. Thus, openings in the torus balloon allow blood flow while the balloon is inflated; in the absence of such openings, the inflated balloon would occlude the vessel lumen, thereby blocking flow. In preferred embodiments, as the balloon is inflated, the energy emitter comes into contact with the target tissue, e.g., calcification in the vessel lumen.

[0045] In some embodiments, the catheter includes a second lumen, the first lumen being dedicated solely to inflation and deflation of the torus balloon.

[0046] In some embodiments, the catheter includes an energy emitter. In other embodiments, the catheter includes multiple energy emitters spaced apart on the torus balloon. In some embodiments, at least one energy emitter comprises multiple ultrasound emitting elements.

[0047] In some embodiments, the torus balloon has an opening for allowing blood to pass through. In some embodiments, the torus balloon can be mounted eccentrically (e.g., offset from the longitudinal axis of the catheter) so that some or most of the balloon is offset to one side of the longitudinal axis and the balloon passage is parallel to the longitudinal axis of the catheter. In some embodiments, the torus balloon has a conduit that houses the catheter, the conduit being radially spaced from the passage.

[0048] In some embodiments, the torus balloon has a circumferentially extending outer surface, the passageway of the torus balloon is parallel to the longitudinal axis of the catheter, and the at least one energy emitter includes multiple energy emitters around the torus balloon to apply energy radially from the periphery of the balloon.

[0049] In some embodiments, the catheter includes a filter positioned distal to the torus balloon to capture particles. Filters may optionally be provided in other catheters disclosed herein.

[0050] According to another aspect of the present invention, there is provided a method of disrupting a valve, comprising the steps of introducing the aforementioned torus balloon into the valve, inflating the torus balloon, releasing energy for a period of time, then ceasing the release of energy, deflating the balloon, and removing the catheter.

[0051] In some embodiments, the inflation, energy release, and deflation are repeated at least two times prior to removal of the catheter.

[0052] According to another aspect of the present invention, there is provided a catheter for intraluminal lithotripsy, comprising an outer wall and at least one balloon extending from the outer wall, the balloon having a first portion, a second portion proximal to the first portion, and an intermediate portion between the first and second portions, the intermediate portion having a transverse dimension smaller than the transverse dimensions of the first and second portions. The catheter has a first lumen, at least one energy emitter supported / supported or attached to the balloon for emitting energy to fracture or soften calcification, and a connector extending through the catheter for connecting the at least one energy emitter to an external energy source.

[0053] In preferred embodiments, the balloon is a torus balloon. In some embodiments, the balloon has a figure-eight configuration.

[0054] In some embodiments, the catheter allows for sustained inflation of the balloon within the heart valve without significantly obstructing outflow from the heart.

[0055] In some embodiments, the at least one energy emitter includes an energy emitter on a second portion of the torus balloon facing the first portion and at least one energy emitter on the first portion of the torus balloon facing the second portion. In some embodiments, the first and second portions are configured to press on opposite sides of the heart valve. In some embodiments, the middle portion of the balloon forms a waist portion that provides a gap between the first and second portions of the torus balloon. The waist portion can be configured to be positioned at the heart valve orifice, such that the first and second portions of the torus balloon press on opposite sides of the heart valve, e.g., press on opposite sides of the valve leaflets.

[0056] In some embodiments, the balloon has an opening that provides a passageway for blood. In some embodiments, the balloon is mounted eccentrically (e.g., offset from the longitudinal axis of the catheter) so that a portion, e.g., a majority of the balloon, is offset to one side of the longitudinal axis and the passageway is parallel to the longitudinal axis. In some embodiments, the balloon has a conduit that accommodates the catheter, the conduit being radially spaced from the opening in the balloon.

[0057] In some embodiments, the catheter has a filter member positioned distal to the balloon to capture particles.

[0058] In some embodiments, the catheter has an outer wall, a lumen, a first hole in the distal portion located distal to the balloon, and a second hole located on a side of the outer wall spaced proximally from the first hole and located proximally of the balloon, wherein blood flows through the second hole and the first lumen and out the first hole while the balloon is inflated and energy is emitted by the at least one energy emitter.

[0059] In some embodiments, the axial sliding member is slidable relative to the catheter, and the catheter and sliding member are movable relative to each other to selectively cover and expose the second aperture, the covering of the second aperture restricting blood flow through the second aperture. In some embodiments, the axial sliding member is external to the catheter, and in other embodiments, the axial sliding member is internal to the catheter.

[0060] In some embodiments, the catheter includes a valve that restricts retrograde blood flow in the elongate member.

[0061] In some embodiments, the energy emitter applies ultrasonic energy.

[0062] According to another aspect of the present invention, a) inserting into a blood vessel an instrument having at least one balloon extending from an outer wall, the balloon having a first portion, a second portion proximal to the first portion, and an intermediate portion between the first and second portions, the intermediate portion having a lateral dimension smaller than the lateral dimensions of the first and second portions of the balloon, at least one energy emitter on the first portion of the balloon and at least one energy emitter on the second portion of the balloon; b) positioning the balloon adjacent to the heart valve such that a first portion faces a first side of the valve, a second portion faces a second opposite side of the valve, and an intermediate portion is positioned at the valve orifice; c) applying energy to at least one energy emitter to apply energy to the first and second sides of the heart valve to break down or soften the calcification;

[0010] A method for reducing calcification in a heart valve of a patient is provided, comprising:

[0063] In some embodiments, the balloon is a torus balloon and is eccentrically mounted (e.g., offset from the longitudinal axis of the catheter) and has an opening for passage of blood through the heart valve (e.g., such that the opening is offset from the longitudinal axis of the catheter) that is also eccentrically positioned.

[0064] In some embodiments, the balloon is a torus balloon, and the catheter has an outer wall, a lumen, a first hole in a distal portion disposed distally of the torus balloon, and a second hole disposed proximally of the torus balloon and disposed on a side of the outer wall, spaced proximally from the first hole, wherein blood flows through the second hole and the first lumen and exits through the first hole while the torus balloon is inflated to bypass the heart valve. In some embodiments, the balloon is a torus balloon, and the torus balloon is inflated to occlude the lumen of the blood vessel, the first portion pressing against a first side of the heart valve and the second portion pressing against a second side of the heart valve, and blood bypasses the inflated balloon when the energy emitter applies energy to the first and second sides of the heart valve.

[0065] In another aspect of the present disclosure, a catheter for intraluminal lithotripsy is disclosed. The catheter includes a catheter body, an energy delivery member supported on the catheter body such that the energy delivery member extends radially outward, and a connector. The catheter body defines a longitudinal axis and includes a first lumen extending therethrough. The energy delivery member includes a body, a passageway extending within the body generally parallel to the longitudinal axis, a valve disposed within the passageway to prevent blood flow through the energy delivery member, and an energy emitter configured to deliver energy to target tissue to facilitate treatment thereof. In some embodiments, the energy emitter is supported adjacent an outer surface of the body. A connector extends from the energy emitter to an external energy source to supply energy to the energy emitter.

[0066] In some embodiments, the first lumen is configured to accommodate an ancillary medical device.

[0067] In some embodiments, the energy delivery member can be supported on the catheter body such that the passageway is positioned eccentrically relative to the longitudinal axis.

[0068] In some embodiments, the energy delivery member may be expandable (eg, inflatable).

[0069] In some embodiments, the energy delivery member can include a proximal portion, a distal portion, and an intermediate portion disposed between the proximal and distal portions. In some embodiments, the proximal and distal portions can each define a first cross-sectional dimension, and the intermediate portion can define a second cross-sectional dimension smaller than the first cross-sectional dimension, such that the energy delivery member includes a waist defining a gap configured to accommodate the target tissue upon expansion of the energy delivery member.

[0070] In some embodiments, the energy delivery member may include a generally toroidal (torus) configuration.

[0071] In some embodiments, the energy delivery member may be substantially cylindrical.

[0072] In some embodiments, the energy delivery member may define a proximal end face and a distal end face. In some embodiments, the proximal end face and the distal end face each may have a generally planar configuration. In some embodiments, the energy emitter may be supported adjacent at least one of the proximal end face and the distal end face of the energy delivery member.

[0073] In some embodiments, the energy delivery member may include a deformable material to allow for reconfiguration of the energy delivery member during insertion and removal of the catheter.

[0074] In some embodiments, the energy delivery member may include a first energy delivery member and a second energy delivery member.

[0075] In some embodiments, the first energy delivery member and the second energy delivery member can be configured as separate structures axially spaced apart from one another along the longitudinal axis.

[0076] In some embodiments, at least one of the first energy delivery member and the second energy delivery member may be movable along the catheter body.

[0077] In some embodiments, the catheter is steerable.

[0078] In some embodiments, the valve opens intermittently. In some embodiments, a pressure gradient across the valve causes the valve to open. In some embodiments, blood flows through the valve when the valve is open.

[0079] In some embodiments, the valve is configured to treat a heart valve.

[0080] In another aspect of the present disclosure, a catheter for intraluminal lithotripsy is disclosed. The catheter includes a catheter body, an impeller rotatably disposed within the catheter body to induce blood flow, an energy delivery member extending radially outward, and a connector. The energy delivery member includes a body having a generally annular cross-sectional configuration and, in some embodiments, can be supported adjacent an outer surface of the body. The energy emitter is configured to transmit energy to the target tissue to facilitate treatment, and the connector extends from the energy emitter to an external energy source to supply energy to the energy emitter.

[0081] The catheter body defines a longitudinal axis and, in some embodiments, is configured to house ancillary medical devices therein, or alternatively thereon.

[0082] In some embodiments, the impeller can be configured to selectively direct blood flow within the catheter body in a first (e.g., distal) direction and a second (e.g., proximal) direction that is opposite (or generally opposite) the first direction.

[0083] In some embodiments, the impeller is disposed within the lumen of the catheter. In some embodiments, the impeller is disposed in the passageway of the energy delivery member.

[0084] In some embodiments, the catheter body can define a first lumen configured to accommodate the impeller and a second lumen configured to accommodate a secondary medical device.

[0085] In some embodiments, the catheter body and impeller can be configured such that the impeller rotates around the ancillary medical device upon insertion of the ancillary medical device into the catheter body.

[0086] In some embodiments, the energy delivery member may be expandable (eg, inflatable).

[0087] In some embodiments, the energy delivery member can include a proximal portion, a distal portion, and an intermediate portion disposed between the proximal and distal portions. In some embodiments, the proximal and distal portions can each define a first cross-sectional dimension, and the intermediate portion can define a second cross-sectional dimension smaller than the first cross-sectional dimension, such that the energy delivery member includes a waist defining a gap configured to accommodate the target tissue upon expansion of the energy delivery member.

[0088] In another aspect of the present disclosure, a method of performing an intraluminal ablation procedure is disclosed that includes inserting a catheter having a catheter body and an energy delivery member supported in the catheter body such that the energy delivery member extends radially outward, the energy delivery member including a passageway extending therethrough; intermittently blocking blood flow through the energy delivery member using a valve supported in the passageway; positioning the energy delivery member adjacent to a target tissue; and applying energy to the energy delivery member to treat the target tissue.

[0089] In some embodiments, applying energy to the energy delivery member may involve transmitting energy from an external energy source to an energy emitter carried in proximity to or on an exterior surface of the energy delivery member.

[0090] In some embodiments, positioning the energy delivery member in proximity to the target tissue may include expanding the energy delivery member such that the target tissue is contained within a gap defined between proximal and distal portions of the energy delivery member.

[0091] In some embodiments, positioning the energy delivery member proximate to the target tissue can include positioning a first energy delivery member distal to the target tissue and a second energy delivery member proximal to the target tissue, hi some embodiments, the target tissue is a valve, such as a heart valve.

[0092] In some embodiments, the method may further include inducing blood flow within the catheter by rotating an impeller disposed within the catheter body.

[0093] The invention will be better understood and objects other than those set forth above will become apparent upon consideration of the following detailed description, which refers to the accompanying drawings, in which: [Brief explanation of the drawings]

[0094] [Figure 1] FIG. 1 is a side view of one embodiment of the bypass catheter of the present invention. [Figure 1A] FIG. 2 is a cross-sectional view of the catheter of FIG. 1. [Figure 1B] FIG. 2 is a cross-sectional view of an alternative embodiment of the catheter of FIG. 1. [Figure 1C] FIG. 2 is a cross-sectional view of another alternative embodiment of the catheter of FIG. 1. [Figure 2] FIG. 10 is a side view of an alternative embodiment of a bypass catheter showing the inner diameter of the proximal segment in dashed lines. [Figure 3] FIG. 10 is a side view of an alternative embodiment of a bypass catheter of the present invention shown connected to a pressurized fluid column via a third hole in the proximal end of the catheter. [Figure 4] FIG. 10 is a side view of an alternative embodiment of a bypass catheter of the present invention having perforations for infusion of medication from the catheter into the blood vessel. [Figure 4A] FIG. 5 is a cross-sectional view of the catheter of FIG. 4. [Figure 4B] FIG. 5 is a cross-sectional view of an alternative embodiment of the catheter of FIG. 4. [Figure 4C] FIG. 5 is a cross-sectional view of another alternative embodiment of the catheter of FIG. 4. [Figure 5] FIG. 10 is a side view of an alternative embodiment of the bypass catheter of the present invention. [Figure 6] FIG. 10 is a side view of an alternative embodiment of a bypass catheter of the present invention having an ultrasound energy emitter. [Figure 6A] FIG. 7 is a cross-sectional view of the catheter of FIG. 6. [Figure 7] FIG. 10 is a side view of an alternative embodiment of the bypass catheter of the present invention having multiple electrodes. [Figure 7A] FIG. 8 is a cross-sectional view of the catheter of FIG. 7. [Figure 8] FIG. 10 is a side view of an alternative embodiment of the bypass catheter of the present invention having a rotational mechanical thrombectomy device. [Figure 9] FIG. 10 is a side view of an alternative embodiment of a bypass catheter of the present invention having a filter attached to the distal segment. [Figure 10] FIG. 10 is a side view of an alternative embodiment of a bypass catheter of the present invention having a filter anchored at its distal end. [Figure 11] FIG. 1 is a side view of an alternative embodiment of a bypass catheter of the present invention having a filter and an expansion member (e.g., a balloon) having a plurality of electrodes connected thereto, the expansion member shown in an inflated state. [Figure 12] FIG. 1 is a side view of an alternative embodiment of a catheter of the present invention having an energy delivery member having a plurality of energy emitters (e.g., electrodes) supported thereon (connected thereto). [Figure 12A] FIG. 13 is a side view of an alternative embodiment of the bypass catheter of FIG. 12, in which the energy delivery member includes a valve. [Figure 12B] FIG. 12B is a side view of an alternative embodiment of the bypass catheter of FIG. 12A, in which the energy delivery member includes a different toroidal (torus) configuration. [Figure 12C] FIG. 12C is a side view of an alternative embodiment of the bypass catheter of FIG. 12B. [Figure 13] FIG. 10 is a side view of an alternative embodiment of a catheter of the present invention for retrograde flow. [Figure 14] FIG. 10 is a side view of an alternative embodiment of a bypass catheter of the present invention, expandable to include a waist defining a gap to which an energy delivery member is concentrically attached and configured to accommodate a target tissue. [Figure 14A] FIG. 15 is a side view of an alternative embodiment of the bypass catheter of FIG. 14 including a valve positioned to block blood flow in the bypass catheter. [Figure 14B] 15 is a side view of an alternative embodiment of the bypass catheter of FIG. 14 in which the energy delivery member is eccentrically mounted and includes a valve that blocks blood flow in a first (e.g., proximal) direction. [Figure 14C] FIG. 14C is a side view of an alternative embodiment of the bypass catheter of FIG. 14B, in which a valve is configured to block blood flow at the energy delivery member in a second (e.g., distal) direction. [Figure 14D] 14C illustrates a method of treating a target tissue (eg, a calcified heart valve) using the bypass catheter of FIG. 14B. [Figure 14E] FIG. 14C is a side view of an alternative embodiment of the bypass catheter of FIG. 14B including a different valve. [Figure 15] FIG. 15 is a side view of an alternative embodiment of the bypass catheter of FIG. 14, in which the energy delivery member defines a passageway extending therethrough. [Figure 15A] FIG. 16 is a side view of an alternative embodiment of the bypass catheter of FIG. 15 including a valve disposed within the passageway. [Figure 16] FIG. 15 is a side view of an alternative embodiment of the bypass catheter of FIG. 14. [Figure 16A] FIG. 14C is a side view of an alternative embodiment of the bypass catheter of FIG. 14B, including a proximal (first) energy delivery member with a valve and a (separate) distal (second) energy delivery member. [Figure 17] FIG. 15 is a side view of an alternative embodiment of the bypass catheter of FIG. 14, in which the energy delivery member includes a toroidal (torus) configuration. [Figure 18] FIG. 18 is a side view of an alternative embodiment of the bypass catheter of FIG. 17 including first and second energy delivery members each having a toroidal (torus) configuration. [Figure 19] 15 is a side view of an alternative embodiment of the bypass catheter of FIG. 14, in which the energy delivery member comprises a (substantially) planar (e.g., disk-shaped) configuration. [Figure 19A] FIG. 20 is a side view of an alternative embodiment of the bypass catheter of FIG. 19, in which the energy delivery member is supported by multiple braces. [Figure 20]FIG. 20 is a side view of an alternative embodiment of the bypass catheter of FIG. 19, in which the energy delivery member is eccentrically mounted and includes a valve to block blood flow. [Figure 20A] FIG. 21 is a side view of an alternative embodiment of the bypass catheter of FIG. 20. [Figure 21] FIG. 21 is a side view of an alternative embodiment of the bypass catheter of FIG. 20, including a proximal (first) energy delivery member and a (separate) distal (second) energy delivery member. [Figure 21A] FIG. 22 is a side view of an alternative embodiment of the bypass catheter of FIG. 21, in which the proximal energy delivery member is movable via a pusher. [Figure 21B] FIG. 21B is a side view of an alternative embodiment of the bypass catheter of FIG. 21A, in which each of the proximal and distal energy delivery members is movable via a corresponding pusher. [Figure 22] FIG. 15 is a side view of an alternative embodiment of the bypass catheter of FIG. 14, including an impeller for directing blood flow within the bypass catheter. [Figure 22A] FIG. 23 is a side view of an alternative embodiment of the bypass catheter of FIG. 22. [Figure 23] FIG. 12C is a side view of an alternative embodiment of the bypass catheter of FIG. 12B, in which the impeller is incorporated into (supported by) the energy delivery member. [Figure 24A] FIG. 1 is a perspective view illustrating the insertion of a delivery (outer) catheter during a surgical procedure. [Figure 24B] 24B is a perspective view illustrating the insertion of an alternative embodiment of the bypass (inner) catheter of FIG. 21 into the delivery catheter of FIG. 24A. FIG. [Figure 24C] FIG. 24C is a perspective view illustrating deployment of the distal energy delivery member of the catheter of FIG. 24B. [Figure 24D] FIG. 24D is a perspective view illustrating retraction of the delivery catheter and bypass catheter of FIG. 24C. [Figure 24E] FIG. 24E is a perspective view illustrating deployment of the proximal energy delivery member of the catheter of FIG. 24D and placement of the distal energy delivery member adjacent to the target tissue (eg, the calcified valve). [Figure 24F] FIG. 24F is a perspective view illustrating the placement of the proximal energy delivery member of the catheter of FIG. 24E adjacent to the target tissue. [Figure 25] 15 is a schematic representation of an alternative embodiment of the (bypass) catheter of FIG. 14, shown in a first (initial, normal) configuration. [Figure 26] FIG. 26 is a cross-sectional view of the bypass catheter taken along line 26-26 in FIG. 25. [Figure 27] 26 is a schematic representation of the bypass catheter of FIG. 25 shown in a second (subsequent, flexed) configuration. DETAILED DESCRIPTION OF THE INVENTION

[0095] In some embodiments, the present invention provides catheters and methods for use in a patient's blood vessel during clot treatment procedures. The catheter advantageously provides blood flow during various clot treatment / removal procedures, such as mechanical thrombectomy, utilizing rotating elements to break up clots, devices to deliver thrombolytic agents to dissolve clots, devices to deliver vibrational energy in the form of continuous or pulsatile waves, devices to deliver energy to assist and / or induce clot removal, and the like, as well as combinations thereof. These various embodiments are described in detail below.

[0096] The devices of the present invention provide control of blood flow during a procedure, allowing for immediate, and if desired, continuous, reperfusion during the procedure. These may, for example, provide for the rapid restoration of temporary blood flow at an occlusion to avoid ischemic injury, and may allow for the immediate restoration of some flow beyond the clot. This may allow additional time for the clot or other obstruction to be treated, e.g., removed or dissolved, while still allowing flow to the tissue at risk.

[0097] Additionally, in cases of large pulmonary emboli, there is the added problem of cardiac compression due to lack of outflow from the right side of the heart. The temporary bypass catheters described herein can also help relieve such cardiac compression by allowing outflow from the right heart past the mass when there is a large pulmonary embolus in the main pulmonary artery.

[0098] The present invention provides, in some embodiments, catheters for use in intracavitary lithotripsy and, in certain applications, for softening calcification of highly calcified valves, such as heart valves, as described in more detail below. For example, it is contemplated that the catheters described herein may be used preoperatively to soften any such calcifications.

[0099] Generally, the devices of the present invention achieve such reperfusion by providing a catheter that is deployed across the occlusion of a blood vessel. In some embodiments, the catheter is a bypass catheter having a distal opening and at least one proximal intravascular opening that serves as a bypass window, such that when the catheter is positioned across the occlusion of the blood vessel, the openings are positioned within the blood vessel on either side of the clot to be treated. This allows blood flow from areas proximal to the clot to areas distal to the clot. In some embodiments, the catheter includes additional structures or features that restrict retrograde blood flow to enhance the reperfusion function of the catheter.

[0100] In some embodiments, the present invention utilizes improvements in temporary bypass catheters and balloons, single lumen support catheters, and rotational thrombectomy devices for irrigation and aspiration.

[0101] In some embodiments, the device may further comprise a semi-permeable filter circumferentially attached at or near its distal end to minimize embolic risk during the procedure. The filter may be self-expanding. The filter may have various configurations to collapse and expand as desired. In some embodiments, the filter may be attached to a wire that extends throughout the lumen of the device and deploys distally within the vessel. In some embodiments, the filter is distal to the distal end lumen and is anchored to the catheter.

[0102] Referring now to the drawings and specific embodiments of the present disclosure, in the several figures in which several embodiments of the catheter of the present invention are illustrated, like reference numerals identify similar structural features of the devices disclosed herein.

[0103] It should be noted that, as used herein, the terms "proximal" and "distal" refer to the direction of blood flow, with blood flowing in a proximal-to-distal direction. It should also be noted that the terms "apparatus," "device," and "catheter" are used interchangeably herein. It should also be noted that the terms "hole" and "opening" are used interchangeably herein.

[0104] "Blood clot treatment," as used herein, includes any type of clot treatment, which may include partial removal of the clot, reduction in clot size, complete removal of the clot, removal by mechanical thrombectomy, dissolution with drugs, etc. The devices of the present invention may also be used for other vascular treatments, including removal of obstructions along with other intravascular debris. Thus, the terms "blood occlusion treatment" or "vascular occlusion treatment," as used herein, include clot occlusions or other occlusions.

[0105] Referring to FIG. 1, a first embodiment of a bypass catheter of the present invention is illustrated. It should be noted that the catheters disclosed herein may also be referred to as instruments or devices. The catheter, generally designated by reference numeral 1a, is in the form of an elongate member, preferably tubular, and in some embodiments has a proximal (end) hole (opening) 7 for attachment to an external terminal device, a distal end hole 4 in the distal section, and a side hole (bypass window) 2 disposed at the outer diameter, i.e., in the wall 14 of the device 1 at the junction of the first (distal) segment 5 and the second (proximal) segment 6. It should be noted that catheter 1a may be a unitary tubular structure as shown, and thus segments 5 and 6 refer to two regions or portions of catheter 1a. However, segments 5 and 6 may alternatively comprise separate elongate tubular members that are attached / joined together. The side hole (2) defines the end of the second segment (6), or at the proximal end of segment (5), and blood enters through the side hole (2) and exits through the distal hole (4). In the illustrated embodiment, the outer diameters of the first segment (5) and second segment (6) are the same. However, in alternative embodiments of the catheters disclosed herein, the outer diameter of segment (5) may be larger or smaller than the outer diameter of segment (6), and one or both segments may have a tapered shape. Also, while a single side hole is shown throughout the drawings of the various embodiments, it is contemplated that the bypass catheters disclosed herein may be provided with more than one side hole for blood inflow. Similarly, multiple outflow holes may be provided. However, when no intervening vessel branches are involved, a single end hole is preferred to maximize laminar flow, minimize turbulence, and maximize flow rate and velocity.

[0106] The bypass catheter 1a is most often introduced through an incision in a patient's blood vessel, often under fluoroscopic guidance, and navigated through the vasculature to a target site, often using standard endovascular techniques, with the aid of a wire, e.g., a guidewire, and / or a delivery catheter. The catheter may be inserted over a guidewire that extends through the proximal opening 7 and lumen 17 of the catheter 1a and exits through the distal opening 4. While the lumen 17 is illustrated as having a circular (or approximately circular) cross-sectional configuration (e.g., diameter), alternative configurations are contemplated herein. For example, it is contemplated that the lumen 17 may have a non-circular cross-sectional configuration (e.g., square, rectangular, hexagonal, octagonal, pentagonal, "house" silhouette, oval, elliptical, star-shaped, etc.). In the context of a star-shaped cross-sectional configuration, any shape of star may be used, including a six-pointed star, a "Star of David," etc.

[0107] In some embodiments, the first or distal segment 5 includes structure for anchoring the device 1 a within the vessel to position and maintain the side hole 2 at the desired location. This structure may include, for example, an expansion wire that expands to at least the size of the vessel's inner diameter to hold the device 1 a in place. Alternatively, an expansion balloon, such as balloon 8 shown in FIG. 1, attached to the first segment 5 may be provided. The balloon 8 may also act to regulate flow, thereby helping to control contact between any delivered agent and any mass. The balloon 8 is inserted in a deflated, stored position. Upon inflation, via injection of fluid (liquid or gas) into the catheter 1 a's lumen 15, which communicates with the interior of the balloon 8, the balloon 8 expands from the stored state to an expanded position at least to the inner diameter of the vessel, thereby anchoring the catheter 1 a in the desired location. It should be noted that catheter 1a may include a separate conduit or lumen 15 (see FIG. 1A) for the injection of inflation fluid, e.g., saline, to expand balloon 8 or for the passage of a wire or other elongate mechanism for expanding the wire in embodiments in which a mechanical dilator is used instead of a balloon to secure catheter 1a. In preferred embodiments, an additional lumen is provided within or substantially within the wall of the catheter to minimize any obstruction within the primary central lumen and maximize blood flow in the bypass segment. As defined herein, the term substantially within (or substantially embedded in) the wall means that more than 75% of the lumen is within the wall, either radially relative to the wall or longitudinally along its length. While the securement device, e.g., balloon 8, is shown as being located between side hole 2 and distal hole 4, it may alternatively be located in other regions of the catheter, such as in the second (proximal) segment 6, proximal to side hole 2. It should be noted that the other bypass catheters disclosed herein may be provided with anchoring structures, and in some embodiments, no anchors are provided.

[0108] Although lumen 15 is illustrated as including a circular (or near-circular) cross-sectional configuration (e.g., diameter), alternative configurations are contemplated herein. For example, it is contemplated that lumen 15 may include a non-circular cross-sectional configuration (e.g., square, rectangular, hexagonal, octagonal, pentagonal, "house" silhouette, oval, elliptical, star-shaped, etc.). In the context of a star-shaped cross-sectional configuration, any shape of star may be used, including, for example, a six-pointed star, a "Star of David," etc.

[0109] As shown in FIG. 1A, lumen 15 is disposed within a central lumen 17. Alternatively, lumen 15' (FIG. 1B), which performs the same function as lumen 15, may be embedded or substantially embedded in the wall of catheter segment 5. The primary central lumen for blood flow is designated by reference numeral 17'. Alternatively, lumen 15" (FIG. 1C), which performs the same function as lumen 15, may be adjacent to the wall of catheter segment 5 so as to share the wall of catheter segment 5. The primary central lumen for blood flow is designated by reference numeral 17".

[0110] The device 1a of the present invention is configured such that a side port 2 is provided in a position to receive blood flow from the patient and direct the blood through the lumen 17 of the first segment 5 and out the distal port 4, thereby bypassing the blood flow at the occlusion. As noted above, one side port 2 is illustrated; however, it is contemplated that more than one side port 2 may be provided in the catheter 1a, as well as in other catheters described herein, to provide more than one inlet pathway for blood flow into the catheter in areas proximal to the vascular occlusion.

[0111] In some embodiments, an external termination device is attached to provide at least one additional third proximal end port that remains outside the patient's body at all times. Optionally, suction from an external suction device can be applied to the third proximal end port when desired to remove clots and debris from the vessel.

[0112] In some embodiments, additional lumens may be located within or substantially within the wall of the catheter, potentially improving catheter flexibility by taking a spiral or corkscrew-like path within the wall to reach (or extend to) the balloon. Similarly, as in the embodiments described below, any wires within the device, e.g., within or substantially within the wall, when present, may in some embodiments take a similar spiral or corkscrew-like path within the wall. Alternatively, in some embodiments, additional lumens for delivery of fluids, such as medicaments, to the fenestrations and / or for inflating and deflating the balloon may pass completely freely within the intravascular portion of the single primary central lumen, except for the fenestrations and the proximal attachment of the balloon. In effect, additional microcatheters are attached only distally through the outer catheter.

[0113] It should be noted that in some embodiments where additional lumens are provided passing through the intravascular segment of the elongate body, the device may be divided proximally into multiple lumens with independent outer walls, preferably outside the patient's body, each lumen preferably terminating at its proximal end with an independent external termination device, such as a luer lock or hub with a diaphragm.

[0114] The catheters of the present invention may include structures or features that prevent backflow of blood in lumen 17. Three alternatives that may be used alone or in one or more combinations and that may be used with any of the bypass catheter embodiments disclosed herein are discussed below.

[0115] FIG. 1 illustrates an embodiment employing a valve 3 disposed within the primary central lumen at the junction of the second section 6 and the side hole 2. The valve 3 can take various forms, such as a leaf valve, a flapper valve, etc. The valve can be configured to allow blood flow in one direction, i.e., the distal direction, thereby preventing proximal flow without any clinician intervention. Alternatively, the valve can be configured to open with clinician intervention. For example, in the embodiment of FIG. 1, once the device 1 is positioned at a desired location adjacent to a clot to be treated, e.g., removed, the valve 3 can be closed by the user (clinician) to prevent blood entering through the side hole 2 from flowing back into the second segment 6. The valve can be controlled at a proximal region of the catheter 1 by a control attached to the valve by a wire or other elongate member. By closing valve (3), blood is thus directed through first segment (5) and lumen (17) of segment (5) and out distal end hole (4), allowing perfusion of the tissue at risk. Alternatively, the valve may be in a default closed position, opening when the wire is passed through and later automatically closing when the wire is removed.

[0116] During use of the device 1, the distal segment 5 is placed at the target tissue (e.g., a mass, a calcified heart valve, etc.), and blood can bypass the target tissue through the distal segment 5 (depending on the direction of blood flow). For example, it is envisioned that blood can flow through the side hole 2 and the distal segment 5 and exit through the distal end hole 4, or alternatively, blood can flow through the distal end hole 4 and the distal segment 5 and exit through the side hole 2. The device 1 is configured such that the proximal end hole 7 is positioned external to the patient (e.g., to allow for aspiration of debris, mass, etc.), thereby preventing the proximal segment 6 from participating in the bypass procedure.

[0117] In one method of use, when side holes (2) become covered (e.g., by patient tissue), the bypass is closed and blood does not flow through device (1). However, it is envisioned that blood can be backbleed or actively aspirated from the body (e.g., via proximal end holes (7)) to establish blood flow.

[0118] In an alternative embodiment depicted in FIG. 2, instead of a valve, the inner diameter 10 of the second segment 6 is smaller than the inner diameter of the first segment 5. That is, the inner wall of the second segment 6 may be thicker to provide a smaller diameter lumen compared to the lumen of segment 5, or the second segment 5 may have a smaller diameter portion that forms a smaller lumen. The inner diameter 10 terminates in an inner lumen 11. The inner lumen 11 is shown smaller than the distal end lumen 4. The difference in inner diameters acts to restrict backflow and direct blood through the first segment 5 to the end lumen 4. In all other respects, the catheter 1b of FIG. 2 is the same as the catheter 1a of FIG. 1 and may optionally include anchoring structures such as a balloon 8 and a valve, but in a preferred embodiment does not have a valve.

[0119] In some embodiments, the valve 3, small inner diameter portion 10, and lumen 11 are adapted to restrict the backflow of blood. As noted above, the valve may be configured to naturally allow one-way blood flow, or alternatively, the valve may be manipulated by a clinician between an open position that allows blood flow and a closed position that restricts blood flow when desired.

[0120] In another embodiment, depicted in FIG. 3, pressurized fluid can be introduced into the second segment (6) to prevent backflow of blood. FIG. 3 depicts the device (1c) connected to a pressurized fluid bag (12) that interacts with the proximal end hole (7) via tubing (13), an appropriate connector, and an external termination device at the proximal end hole. Other sources of pressurized fluid, such as an infusion device, are also contemplated. The proximal end hole (7) communicates with the first segment (5) through the second segment (6) via a lumen extending therethrough. The pressurized fluid bag (12) can be connected to a flow regulator outside the patient's body so that the user of the device can control the flow of fluid through the second segment (6). A pressure gauge can also be provided to adjust the pressure of the fluid delivered through the catheter. Similar to the catheter (1a) of FIG. 1, the catheter (1c) of FIG. 3 has a side hole (2) for the inflow of blood to bypass the obstruction and the distal hole (4) described above.

[0121] To prevent backflow of blood in segment 6, pressurized fluid may be used alone or in conjunction with valve 3, as shown in FIG. 3, and / or in conjunction with a small diameter lumen 11. Stated differently, pressurized fluid, valve 3, and the difference between lumen 10 and lumen 11 may all be used simultaneously, or only one or two of these features may be used in the catheters disclosed herein. In some embodiments, the outer diameters of proximal segment 6 and distal segment 5 may also vary. This is particularly beneficial when used in conjunction with an expandable sheath, such as the Edwards Lifescience e-sheath, to limit the sheath size required to introduce the larger diameter distal segment 6 into a lesion.

[0122] In some embodiments, a catheter or sheath balloon (described below) may be provided that can be selectively inflated when desired to inhibit flow and / or backflow during a mass treatment process, such as a maceration process, to prevent showering of the mass or to aspirate the mass and debris.

[0123] In some embodiments, the catheter may have a filter or distal protection device in its distal portion. Figures 9-11 illustrate three embodiments of such filters attached in different ways. Note that these filters may be utilized with any of the device (catheter) embodiments disclosed herein, and Figures 9-11 illustrate several examples of such catheters.

[0124] In the embodiment of FIG. 9, filter 101 is attached to the distal end of catheter 100 and terminates in end hole 104. Catheter 100, like other catheters disclosed herein, has a proximal opening 107, a side hole 102 for blood inflow (such as side hole 2 in FIG. 1), and a distal end hole 104 for blood exit in a bypass procedure disclosed herein. In the embodiment of FIG. 10, filter 111 is anchored to the distal end of catheter 110 and is therefore located distal to distal end hole 114. Wire 111b is attached to the distal region of catheter 110 and extends distally therefrom. Catheter 110, like other catheters disclosed herein, has a proximal opening 117, a side hole 112 for blood inflow (such as side hole 2), and a distal end hole 114 for blood exit in a bypass procedure disclosed herein. The embodiment of FIG. 11 illustrates a distal filter 130 for use with a catheter equipped with an energy emitter. Figure 11 is considered in more detail below.

[0125] During use of catheters 100, 110, their distal regions are placed at target tissue (e.g., a mass, a calcified heart valve, etc.), and blood can bypass the target tissue at the distal region (depending on the direction of blood flow). For example, it is contemplated that blood can flow through side holes 102, 112 and the distal region and exit through distal end holes 104, 114, or alternatively, blood can flow through distal end holes 104, 114 and the distal region and exit through side holes 102, 112. Catheters 100, 110 can be configured such that their respective proximal openings 107, 117 are positioned outside the patient (e.g., to allow for aspiration of debris, mass, etc. therein), thereby preventing the proximal regions of catheters 100, 110 from participating in the bypass procedure.

[0126] In one method of use, when the side holes 102, 112 are covered (e.g., by patient tissue), the bypass is closed and blood does not flow through the catheters 100, 110. However, to establish blood flow, blood can be backbleed or actively aspirated from the body (e.g., via the proximal openings 107, 117).

[0127] The filters 101, 111, 130 may each comprise a wire, mesh, braid, or other filter material 101 a, 111 a, 131 that blocks / traps particles from migrating downstream within the blood vessel while allowing blood flow therethrough. A plurality of wires 101 b, 111 b, 133 are expandable to move the filters 101, 111, 130, respectively, from a stored state to an expanded position for delivery distal to the occlusion. The filters may be self-expanding or manually controlled by wires connected to the wires 101 b, 111 b, 133 and selectively actuable at a proximal region of the catheter outside the patient's body.

[0128] A semi-permeable filter is circumferentially mounted at or near the distal end of the catheter to minimize the risk of embolization during the procedure. The filter can have a variety of configurations to allow it to be collapsed and deployed as desired. In some embodiments, the filter can be mounted on a wire that extends throughout the lumen of the device and deployed distally within the vessel. The filter can be configured as shown or can be other shapes / configurations.

[0129] Figure 4 illustrates an alternative embodiment of the catheter of the present invention, in which at least one perforation 30 is drilled in the first segment 5. The perforation 30 in the bypass catheter 1d is an end or exit port that communicates with another lumen or passageway 36 (Figure 4A) within the catheter 1d. The conduit 36 ​​extends to the proximal end port 7, providing a separate irrigation (fluid) conduit in communication with a control device 38 via tubing 37 for controlling fluid flow in the conduit 30. Fluid is introduced into the separate conduit 36, flows through the conduit 36 ​​extending through segments 5 and 6, exits the perforation 30, and enters the blood vessel, particularly the clot, where it dissolves the clot's vascular obstruction. For example, the fluid may be a clot-dissolving drug, e.g., a lytic drug such as alteplase. The control device 38 can control / adjust the flow of a drug from the control device through the lumen 36 and out the perforation 30 to induce clot lysis near the first segment 5. Alternatively, other methods, such as manual injection via a syringe, can be employed. This has the ability to soften and / or change the chemical composition of the clot adjacent to the perforation 30 for the purpose of dislodging and / or dissolving the clot or other obstruction. To enhance lysis, an energy source, described in detail below in conjunction with FIG. 6, can be provided.

[0130] Although the lumens of the catheters disclosed herein are illustrated as including circular (or nearly circular) cross-sectional configurations (e.g., diameters), alternative configurations are contemplated herein. For example, it is contemplated that the lumen 36 may include non-circular cross-sectional configurations (e.g., square, rectangular, hexagonal, octagonal, pentagonal, "house" silhouette, oval, elliptical, star-shaped, etc.). In the context of a star-shaped cross-sectional configuration, any shape of star may be used, including, for example, a six-pointed star, a "Star of David," etc.

[0131] One or more perforations 30 may be provided between the side hole 2 and the distal hole 4 of the bypass catheter 1. Alternatively or additionally, one or more perforations 30 may be provided proximal to the side hole 2, as shown in FIG. 4. Fluid exiting the perforations 30 may affect the proximal region of the clot. Note that while FIG. 4 shows the side hole 2 in the central (middle) region of the segment 5, it should be recognized that the side hole 2 may be provided in other regions of the catheter 1d, such as the proximal region of the segment 5, as in the embodiment of FIG. 1. A valve 3 or other flow-restricting structure may be provided.

[0132] The device (1d) of FIG. 4 may be comprised of concentric lumens, with a conduit (36) for the flow of medication communicating with the perforations (30) located in the center of lumen (17). In an alternative embodiment, the conduit is located within the primary lumen but off-center, substantially following the wall of the catheter. In another embodiment, shown in FIG. 4B, the fluid delivery lumen leading to the perforations passes substantially through the wall of the intravascular segment of the catheter. More specifically, in FIG. 4C, conduit 36 ​​is shown adjacent to the wall of catheter segment 5, thus sharing a common wall with the catheter. In the alternative embodiment of FIG. 4A, conduit 36', functioning like conduit 36, is located off-center within primary central lumen 17' of catheter segment 5, functioning like lumen 17. In the embodiment of FIG. 4C, conduit 36" functioning like conduit 36 ​​is embedded in the wall of catheter segment 5. The primary central lumen, functioning like lumen 17, is designated by the reference numeral 17".

[0133] In some embodiments, the perforations (30) communicate with the area between the inner surface of the outer lumen and the outer surface of the inner lumen 36, with a gap extending from the perforations (30) to the proximal end hole (7) and communicating with the control device (38). Thus, a drug can be delivered from the control device (38) through the area between the inner surface of the outer lumen and the outer surface of the inner lumen and out the perforations (30), allowing for the infusion of a drug to soften, dissolve, or otherwise alter the composition of a mass or obstruction. In preferred embodiments, the inner conduit (or the area between the inner surface of the outer lumen and the outer surface of the inner lumen) terminates at the distal-most perforations (30) at end (32). Alternatively, the inner conduit may terminate at first segment (5) at or near end hole (4). In alternative embodiments, one or more slits may be provided along the catheter surface instead of, or in addition to, the perforations, through which the fluid drug can be delivered.

[0134] Referring to FIG. 5, alternative embodiments of the device of the present invention further include rotation, maceration, and flushing elements. More specifically, bypass catheter 10 includes a slidable outer support sheath (60) with a proximal opening (67), a maceration element or loop (70), and / or perforations (30) used as flushing elements to allow the escape of fluids, such as medications to dissolve clots. The slidable outer support sheath (60) provides a hole-covering member, capable of covering side hole (2) when first segment (5) is retracted (moved proximally) inside sheath (60) or when sheath (60) is advanced (moved distally) to cover side hole (2), or tightly closing side hole (2) when sheath (60) is moved distally and first segment (5) is moved proximally. Each of these variations may be considered a relative movement. In either of these methods, such relative movement is utilized to open (expose) and close (cover) side hole (2) as desired by the clinician. Movement of sheath (60) is controlled at the proximal end, and movement of first segment (5) is controlled by movement of catheter 10, which is also controlled at the proximal end. Once side hole (2) is closed, aspiration of intravascular contents through end hole (4) can be achieved by applying external suction to proximal end hole (7). Note that in alternative embodiments, the sheath covering the side hole can be located within the catheter rather than external to it. Such external or internal sheaths can be used with any of the embodiments disclosed herein.

[0135] Maceration element (70) extends radially from catheter (10) and is preferably positioned between side hole (2) and distal hole (4). Maceration element (70) macerates the clot when catheter (10) is rotated, rotating element (70). Such rotation may occur simultaneously with the infusion of agent through perforations (30), aiding in agent mixing or movement. While shown in the form of a loop (70), other maceration configurations are contemplated. In an alternative embodiment, shown in FIG. 8, instead of the maceration element being rotatable by catheter rotation, the maceration element rotates independently of the catheter. As shown in FIG. 8, maceration element 74 in the form of a wire extends radially from bypass catheter 72 and is attached to a rotating shaft 75. Shaft 75 extends into lumen 77 and may be rotated by hand or by a motor 73 located within, or alternatively, external to, the catheter to break up the clot. During maceration, blood flows through side holes 78 and lumen 77 and out distal end hole 76, bypassing the clot. Perforations, such as perforations 30 in Figure 5, may be provided for fluid, e.g., drug, injection. A sliding member, e.g., a sheath, may be provided to selectively cover side holes 78.

[0136] Although lumen 77 is illustrated as including a circular (or nearly circular) cross-sectional configuration (e.g., diameter), alternative configurations are contemplated herein. For example, it is contemplated that lumen 77 may include a non-circular cross-sectional configuration (e.g., square, rectangular, hexagonal, octagonal, pentagonal, a "house" silhouette, an oval, an ellipse, a star, etc.). In the context of a star-shaped cross-sectional configuration, any shape of star may be used, including, for example, a six-pointed star, a "Star of David," etc.

[0137] Returning to FIG. 5, catheter 10 further includes suction control 39 in communication with proximal end lumen 7 via tubing 39a. Such suction is utilized to induce retrograde blood flow through catheter 10. More specifically, when side lumen 2 is not covered by sheath 60, the catheter performs its bypass function for blood entering side lumen 2 and exiting distal end lumen 4, bypassing vascular obstructions in the same manner as side lumen 2 and distal lumen 4 in the previous embodiment. When side lumen 2 is covered by outer support sheath 60 and suction is activated via control 39, this effectively alters the blood flow diversion from side lumen 2 through distal end lumen 4 and instead redirects blood flow from distal end lumen 4 to proximal end lumen 7 via suction control 39 in communication with proximal end lumen 7.

[0138] The device 10 may also include a reflux valve, such as valve 3, or other reflux-limiting features / structures described herein. A balloon 50 may be provided that is expandable with inflation fluid injected into the lumen 52 of the catheter 10, expanding to a diameter equal to or slightly larger than the inner diameter of the blood vessel to secure the catheter in place and / or provide a fixation force to control flow within the blood vessel. Note that while the balloon 50 is shown in the illustrated embodiment proximal to the side hole 2, it may be positioned elsewhere. As noted above, other mechanical fixation elements may alternatively be provided.

[0139] If the surgeon elects to apply suction through distal end port 4, bypass catheter 10 may be pulled back (or sheath 60 moved forward, or both moved relative to each other) so that side port 2 is temporarily positioned within sheath 60 sized to fit snugly around bypass catheter 10, and when ready, valve 3 may be opened during such suction, transferring suction applied to proximal end port 7 to proximal end port 4. It should be noted that for optimal use of this embodiment of the invention, first segment 5 fits snugly, or has at least a minimal gap, against the inside of slidable outer support sheath 60, so that inflow of blood through side port 2 is prevented or completely restricted when sheath 60 covers side port 2.

[0140] It should be appreciated that in alternative embodiments, the hole covering member may be an inner member slidably disposed in the lumen of device (10) and moved distally to close side hole (2), or device 10 may be retracted proximally, or both may be moved relative to each other so that the outer wall of the inner member covers side hole 6, preferably sufficiently tightly, to reduce or close the gap between the outer wall of the inner member and the inner wall of device 10 and restrict blood flow therethrough.

[0141] 6-7A illustrate alternative embodiments of the bypass catheter of the present invention in which energy is applied to treat clots, e.g., to fragment or dissolve the clot. The energy can be used in conjunction with a drug for clot dissolution, or alternatively, can be used without such a drug, relying on mechanical fragmentation of the clot. In some embodiments, ultrasound waves are transmitted. Various frequencies of ultrasound waves can be utilized. Some frequencies are optimal for clot dissolution, some for drug delivery to the clot, some for calcification, some for calcification, some for calcification, and some for other uses.

[0142] Referring first to the device of Figure 6, device (bypass catheter) 80 has a proximal end 82, a distal end 84 terminating in a distal exit (end) hole 86, and a side hole 88 in the outer wall of device 80. As described above, bypass catheter 80 can be thought of as having two segments or portions that are either integral or separate joined components. In this embodiment, bypass catheter 80 has three conduits (lumens): i) a main conduit 85a that enters through side hole 88 in the wall of catheter 80 and exits through distal hole 86, bypassing the clot and providing intermediate perfusion; ii) a conduit 85b for infusion of agents, such as thrombolytic agents, from fluid source B to dissolve the clot; and iii) a conduit 85c that houses wires 89 connecting ultrasound source A to catheter 80, e.g., energy emitters (radiating elements) 87 disposed along the catheter. Note that these three lumens 85a, 85b, and 85c are presented as an example because, in an alternative embodiment, wire 89 may be disposed in fluid line 85b, in which case catheter 80 would have two lumens instead of three. Alternatively, wire 89 may be embedded or substantially embedded in the wall of catheter 80. In a preferred embodiment, both the wire and the additional lumen for fluid / drug delivery are completely or substantially completely embedded in the wall of the intravascular segment of the catheter. This arrangement maximizes flow and perfusion of the distal vascular region during vascular occlusion due to an obstruction, and during vascular occlusion due to an inflated balloon or other obstruction, by limiting obstruction to blood flow through the catheter at the bypass segment. FIG. 6A is a cross-sectional view of catheter 80 showing one possible lumen arrangement; however, it should be recognized that other lumen arrangements and lumen sizes may vary from those shown.

[0143] While the lumens disclosed in FIG. 6A are each illustrated as including a circular (or nearly circular) cross-sectional configuration (e.g., diameter), as are the lumens disclosed in each of the other embodiments described and shown in the drawings, alternative configurations are contemplated herein. For example, the lumens may include non-circular cross-sectional configurations (e.g., square, rectangular, hexagonal, octagonal, pentagonal, "house" silhouette, oval, elliptical, star-shaped, etc.). In the context of a star-shaped cross-sectional configuration, any shape of star may be used, including, for example, a six-pointed star, a "Star of David," etc. Such various lumen configurations are applicable to each of the catheters disclosed herein.

[0144] During use of catheter 80, its distal region is placed at the target tissue (e.g., a mass, a calcified heart valve, etc.), and blood can bypass the target tissue through the distal region (depending on the direction of blood flow). For example, it is contemplated that blood can flow through side holes 88 and the distal region and exit through distal end holes 86, or blood can flow through distal end holes 86 and the distal region and exit through side holes 88. Catheter 80 can be configured such that its proximal end is positioned outside the patient (e.g., to allow for aspiration of debris, mass, etc.), such that the proximal region of catheter 80 is not involved in the bypass procedure.

[0145] In some uses, when the side holes 88 are covered (e.g., by patient tissue), the bypass is closed and blood does not flow through the catheter 80. However, blood may be backbleed or actively aspirated from the body (e.g., through the proximal end of the catheter 80) to establish blood flow.

[0146] 1 and 4, several alternative embodiments (not shown) are possible, including various arrangements in which the secondary and tertiary lumens may be incorporated within or substantially within the wall of the elongate member. Alternatively, the secondary lumens may be within or substantially within the wall, and the tertiary lumens may pass through the primary central lumen, or vice versa.

[0147] Ultrasound source A provides ultrasonic energy through wire 89 to energy emitter 87 to enhance drug flow at the clot. While three energy emitters (also referred to as energy-emitting elements) are shown by way of example, fewer or additional emitters may be provided, and spacing along the length of catheter 80 other than that shown may also be utilized. Also, while emitters 87 are shown disposed on one side of catheter 80 in a longitudinal row, additional emitters may be provided on the other side of the catheter, such as a row on both sides of the catheter spaced 180 degrees from emitter 87 shown, or a longitudinal row of emitters. It is also contemplated that a row of emitters may be radially spaced on the outer wall of catheter 80, rather than longitudinally spaced as shown. Any combination of arrangements on and / or within the catheter and on a balloon or multiple balloons and / or within a balloon and / or multiple balloons is also contemplated. 6, the energy emitter 87 is proximate to the opening 83 that delivers the drug or therapeutic agent to the clot. In an alternative embodiment, the energy emitter is spaced from the opening 83.

[0148] In a preferred embodiment, emitter 87 is positioned between side hole 88 and distal hole 86 as shown. However, it is contemplated that one or more energy emitters 87 may alternatively or additionally be positioned proximal to side hole 88, thereby providing ultrasonic energy to a region of the blood vessel proximal to the clot.

[0149] Wires 89 transmit ultrasonic energy to emitter 87 from an ultrasonic transducer A remote from emitter 87 as shown schematically in FIG. 6A. However, in alternative embodiments, the emitter may include an ultrasonic transducer (which converts electrical energy into ultrasonic energy) connected via a wire to a source of electrical energy. Ultrasonic energy may be emitted as a continuous wave and / or a pulsatile wave, and in waveforms of various shapes, e.g., sine waves. Various frequencies are also contemplated. A microcontroller may be provided to control the output. Alternative forms of energy are also contemplated.

[0150] A temperature sensor may be provided at or adjacent to the emitter 87 to monitor the temperature of the radiant element 87 or tissue during treatment. A cooling element may be provided.

[0151] In use, bypass catheter 80 is typically inserted minimally invasively and advanced within the vessel for placement adjacent to the clot, with side holes 88 positioned proximal to the clot and distal hole 86 positioned distal to the clot, as in the bypass catheters discussed above. This allows blood flow from proximal to past the clot for immediate, and if desired, continuous, blood flow (and tissue reperfusion) throughout the procedure and for as long as the catheter remains in place. A valve or switch on catheter 80 opens the drug source B, or a remote location at or adjacent drug source B for drug flow. Emitting element (emitter) 87 is activated by a switch on catheter 80 or, for example, a remote switch on the energy source, applying energy to emitter 87 via wire 89, applying ultrasonic energy (generating an acoustic field) to the clot and / or vessel, increasing its permeability in the clot and thereby enhancing the drug's effectiveness in dissolving the clot as the drug penetrates deeper into the clot. Activation enhances mixing of the agent via pressure waves and / or cavitation. Ultrasonic energy and fluid injection may be synchronized to occur simultaneously in some embodiments. Alternatively, energy and fluid injection may be applied at separate times / intervals. Because the side holes 88 remain open during ultrasonic energy application and agent delivery, blood flow may continue distal to the mass, avoiding blood disruption that could lead to ischemia or other adverse conditions.

[0152] It should be noted that in alternative embodiments, ultrasonic energy may be used without chemical injection. In such embodiments, pulsed acoustic waves generated by an ultrasonic energy source and emitted by radiating element 87 fragment the clot via cavitation, mechanically breaking up the mass. In alternative embodiments, rotational maceration may also be used to mechanically break up the mass. As previously described, aspiration of the mass and debris may also optionally be performed. Combinations of various techniques may also be used, simultaneously and / or sequentially.

[0153] In the alternative embodiment of Figure 7, a pulse or shock wave generator C is connected to the device (bypass catheter) 90. The generator produces shock waves that propagate through the clot, breaking it up. In some embodiments, the pulse generator C may be utilized in conjunction with a clot-breaking agent. As noted above, shock waves may alternatively be used to break up lime or other hardened materials.

[0154] More specifically, device 90 has one or more energy emitters 97 in the form of electrodes. Like device 80, device 90 has a distal exit (end) hole 96 and at least one side hole 98 in the outer wall of device 90. As described above, bypass catheter 90 can be thought of as having two segments or portions that are either integral or separate joined components. In this embodiment, bypass catheter 90, like device 80, has three conduits (lumens): i) a main conduit 95a for fluid flow that bypasses the clot; ii) a conduit 95b for infusion of a drug, such as a thrombolytic agent, from fluid source B (via tubing 91) to dissolve the clot; and iii) a conduit 95c that houses wires 99 connecting generator C to electrodes 97 disposed along catheter 90, for example. As described above with respect to lumens 85a, 85b, 85c, lumens 95a, 95b, 95c are given as examples, and the variations described above with respect to lumens 85a, 85b, 85c and with respect to wires are fully applicable to lumens 95a, 95b, 95c of catheter 90, whether embedded in the wall of the catheter, centrally located, off-centered, etc.

[0155] During use, catheter 90's distal region is placed at the target tissue (e.g., a mass, a calcified heart valve, etc.), allowing blood to bypass the target tissue through the distal region (depending on the direction of blood flow). For example, it is envisioned that blood could flow through side hole 98 and the distal region and exit through distal end hole 96, or blood could flow through distal end hole 96 and the distal region and exit through side hole 98. Catheter 90 can be configured such that its proximal end is positioned outside the patient (e.g., allowing for the aspiration of debris, mass, etc. therethrough), thereby preventing the proximal region of catheter 90 from participating in the bypass procedure.

[0156] In some uses, when the side holes 98 become covered (e.g., by patient tissue), the bypass is closed and blood does not flow through the catheter 90. However, to establish blood flow, blood can be backbleed or actively aspirated from the body (e.g., through the proximal end of the catheter 90).

[0157] Several alternative embodiments are contemplated, including various arrangements in which secondary and tertiary lumens or electrodes or wires, or combinations thereof, may be incorporated into or substantially within the wall of the elongate member, similar to the secondary lumens of Figures 1 and 4. Alternatively, the secondary lumens may be within or substantially within the wall of the catheter, and the tertiary lumens may pass within the primary central lumen, or vice versa.

[0158] Generator C provides voltage pulses (shock waves) to energy emitters (electrodes) 97, transmitted by connectors or wires 99, such that the shock waves propagate through the blood, impinging on and disrupting clots. Note that three energy emitters are shown by way of example, as fewer or additional emitters may be provided, and spacing along the length of catheter 90 other than that shown may be utilized. Also, while emitters 97 are shown as being located on one side of catheter 90 in a longitudinal row, additional emitters may be provided on the other side of the catheter, for example, a series or longitudinal row of emitters on both sides of the catheter spaced 180 degrees from emitter 97 shown. It is also contemplated that a series of emitters may be spaced radially along the outer wall of catheter 90, rather than spaced longitudinally as shown.

[0159] Generator C may be used in conjunction with drug flow at perforation 93, as in device 80, and an energy emitter 97 that delivers the drug or therapeutic agent to the clot may be positioned adjacent to opening 83 or alternatively spaced apart from opening 83.

[0160] In a preferred embodiment, emitter 97 is located between side hole 98 and distal hole 96 as shown. However, it is contemplated that one or more energy emitters 97 may alternatively or additionally be located proximal to side hole 98, thereby providing shock waves to a region of the vessel proximal to the clot.

[0161] A microcontroller may be provided to control the output. A temperature sensor may be provided at or adjacent to the emitter 97 to monitor the temperature of the electrode or tissue during treatment. A cooling element may be provided.

[0162] With the exception of shock wave delivery, bypass catheter 90 can be inserted and used in the same manner as catheter 80, and therefore the description of the use of device 80 is applicable to the use of device 90. During energy application (and drug delivery, if provided), side holes 98 remain open, allowing blood flow to continue distal to the mass, thereby avoiding disruption of blood flow that could lead to ischemia or other adverse conditions.

[0163] It should be noted that in alternative embodiments, energy may be used without chemical injection, in which case shock waves generated by an energy source and emitted by electrodes 97 fragment the clot via cavitation, mechanically breaking up the clot.

[0164] In some embodiments, the balloon may encase the energy emitter, allowing pulses to be delivered within the balloon. In some embodiments, the energy emitter may encase the balloon, in addition to or instead of being provided within the balloon, allowing pulses to be delivered within or on the balloon. These external emitters are shown in the embodiment of FIG. 11 , where an energy emitter 124, e.g., an electrode, encases a balloon 125 attached to the catheter 120. Like the other bypass catheters disclosed herein, the catheter 120 includes a side hole 122 for blood bypass and a distal end hole 126. The catheter also has a primary lumen for blood flow and a secondary lumen for inflation of the balloon 125. The balloon 125 and energy emitter 124 are positioned between the side hole 122 and the end hole 126, and the emitter emits energy into the blood vessel. An energy source emitter E is connected to the emitter 124 via a wire 127 in the same manner as the other energy emitters disclosed herein. The energy emitter can be in a variety of forms as disclosed herein.

[0165] During use of catheter 120, its distal region is placed at the target tissue (e.g., a mass, a calcified heart valve, etc.), and blood can bypass the targeted tissue through the distal region (depending on the direction of blood flow). For example, it is contemplated that blood can flow through side hole 122 and the distal region and exit through distal end hole 126, or blood can flow through distal end hole 126 and the distal region and exit through side hole 122. Catheter 120 can be configured such that its proximal end is positioned outside the patient (e.g., to allow for aspiration of debris, mass, etc.), such that the proximal region of catheter 120 is not involved in the bypass procedure.

[0166] In some uses, when the side holes 122 become covered (e.g., by patient tissue), the bypass is closed and blood does not flow through the catheter 120. However, blood can be backbleed or actively aspirated from the body (through the proximal end of the catheter 120) to establish blood flow.

[0167] The catheter 120 in the illustrated embodiment includes a filter 130; however, it should be appreciated that the catheter 120 can be provided without a filter. The filter 130 is attached to a wire 128 that extends the length of the catheter for access to a clinician outside the patient at region 128a. A wire 133 supports a filter material 131, and the filter terminates at region 132. The filter 130 may alternatively be attached or anchored to the catheter 120, such as filters 101 and 111 of Figures 9 and 10, respectively.

[0168] A sheath (or inner occluder material), such as sheath 60 of Figure 5, may be provided to selectively open and close side holes 88, 98, 122 of catheters 80, 90, 120, respectively (or the side holes of any of the other catheters disclosed herein) when it is desired to interrupt blood flow through the clot. In some embodiments, catheters 80, 90, 120 may be connected to a suction source, such as suction source 39 described above in conjunction with the catheter of Figure 5, to apply suction to induce backflow of blood through catheters 80, 90 when or as desired.

[0169] Catheters 80, 90, 120 (as well as other catheters 9 disclosed herein) may include structures as described above to limit reflux in the catheter, e.g., valves, restricted openings, etc. Catheters 80, 90, 120 may also include anchoring structures such as wires or inflatable balloons as in the alternative embodiments described above.

[0170] Various forms of energy can be provided to the bypass catheters described herein, such as ultrasonic energy, electrosurgical energy in the form of radio frequency, or microwave energy. Additionally, other types of energy can be applied, including light or laser energy.

[0171] Energy can be applied between the side hole and the distal hole so that the mass can be treated while blood is bypassing the mass as described above for immediate tissue reperfusion. That is, in preferred embodiments, various forms of energy and associated energy emitters or openings for energy emission are located between the side hole and the distal exit hole. However, in alternative embodiments, instead of or in lieu of energy being applied between the side hole and the distal hole, the energy emitter or opening can be located proximal to the side hole and / or can have a structure, such as an antenna or other energy-emitting device, extending distally of the distal hole. When used in conjunction with a drug, immediate reperfusion is beneficial because the injection of a dissolving drug will dissolve the mass over time.

[0172] In an alternative embodiment, a mechanical thrombectomy device having at least one wire or other maceration structure is rotated by a motor located within the catheter, as in the embodiment of FIG. 8, or alternatively, is powered by a motor external to the catheter. The maceration element is attached to a rotating shaft that rotates about its axis upon activation of the motor so that the maceration element breaks up the clots. In a preferred embodiment, the maceration element is located between the proximal and distal holes; however, it may alternatively be attached elsewhere. Alternatively, a maceration wire may be attached to the catheter, and the entire catheter may be rotated for maceration.

[0173] In some embodiments, the catheter may have a complex shape at or near the second catheter segment such that rotation of the catheter itself may cause maceration. One example of such a complex shape is a sinusoidal shape.

[0174] The bypass catheters disclosed herein above have side and distal holes for blood to bypass clots or vascular obstructions. In the alternative embodiment of Figure 12, a torus balloon provides a passageway for blood flow when the balloon is inflated. One balloon type that may be utilized is the inflated torus balloon disclosed in U.S. Patent No. 10,328,246. Other balloon shapes are also contemplated.

[0175] An energy source as described herein can provide energy to an emitter, e.g., an electrode, positioned on or within an inflated torus balloon, which can be used during valvulolysis to allow blood to escape from the heart through the central hole of the balloon during sustained balloon inflation for sustained contact with the valve, or similarly, to allow continuous blood flow within the vessel during use in the vessel without significantly impeding blood flow.

[0176] 12 illustrates a catheter 140 including a catheter body 142 having a (primary working) lumen 143 extending therethrough configured to accommodate one or more auxiliary medical devices (e.g., catheters, instruments, tools, etc.) M, and an energy delivery member 155 supported (e.g., attached or otherwise secured) to the catheter body 142 so that the energy delivery member 155 extends radially outward. In the illustrated embodiment, the energy delivery member 155 is configured as an expansion member (e.g., balloon) 149 and includes a body 159 with a cylindrical (or generally cylindrical) configuration defining opposite (e.g., proximal and distal) end faces 158i, 158ii. In the illustrated embodiment, each of the end faces 158i, 158ii includes a planar (or generally planar) configuration, although non-planar configurations are also contemplated. It should be appreciated that alternative configurations of the energy delivery member 155 are also contemplated herein, as described in more detail below.

[0177] The energy delivery member 155 defines a conduit 153 configured to receive the catheter body 142 such that the catheter body 142 extends therethrough, as shown. The region of the catheter 140 distal to the energy delivery member 155 is designated by the reference numeral 145, and the region of the catheter 140 proximal to the energy delivery member 155 is designated by the reference numeral 146. It should be appreciated that the energy delivery member 155 may be located at any suitable location along the catheter body 142. The catheter has a proximal opening 147 and a distal opening 154 that are fluidly connected by a lumen 143, e.g., a primary central lumen. A port 150 allows for the injection of a fluid (liquid or gas) that expands (e.g., inflates) the energy delivery member 155.

[0178] The energy delivery member 155 includes a passageway 156 (e.g., an opening, a duct, a conduit, etc.) extending within the body 159 parallel (or substantially parallel) to the longitudinal axis X1 defined by the catheter body 142 to allow blood to flow to the energy delivery member 155 during a surgical procedure (e.g., following dilation). While illustrated as being centrally located in the particular embodiment shown in FIG. 12, it is contemplated that the passageway 156 may be eccentrically located (e.g., such that the passageway 156 is radially offset from the center of the energy delivery member 155), as described in more detail below.

[0179] The energy delivery member 155 is mounted eccentrically, such that the energy delivery member 155 and the passages 156 are each radially offset (misaligned) from the longitudinal axis X1 defined by the catheter body 142 (e.g., such that a majority (more than 50%) of the energy delivery member 155 and the passages 156 are offset to one side of the longitudinal axis X1).

[0180] One or more energy emitters 157 are supported by the energy delivery member 155 adjacent the exterior surface (wall, perimeter) 159A of the body 159 and are configured to deliver energy to the target tissue to facilitate treatment thereof. In the particular embodiment shown, for example, the energy delivery member 155 includes multiple energy emitters 157i, 157ii, and 157iii extending circumferentially. While the particular embodiment shown in FIG. 12 is illustrated as including three energy emitters 157, it should be appreciated that the number of energy emitters 157 may be increased or decreased without departing from the scope of the present disclosure. For example, embodiments of the energy delivery member 155 including a single energy emitter 157 are also contemplated herein.

[0181] Expansion (e.g., swelling) of the energy delivery member 155 brings the energy emitters 157 into proximity with the vascular obstruction for emission of energy to treat the clot or other vascular obstruction. The energy emitters 157 are arranged in various arrays and spaced apart in any suitable manner (e.g., around the circumference of the energy delivery member 155). Like the other energy emitters disclosed above, the energy emitters 157 can emit ultrasonic or other energy at various frequencies. The connectors 152 (e.g., one or more wires) connect the energy emitters 157 to an external energy source E, thereby enabling application of energy to the energy delivery member 155 by transmitting energy from the external energy source E to the energy emitters 157. In the illustrated embodiment, the connectors 152 extend within (through) the catheter body 142 (e.g., via the lumen 143). However, it is contemplated that in various disclosed embodiments, the connectors 152 can extend into or substantially into the wall of the catheter or can extend externally from the catheter body 142.

[0182] 12 , the energy emitter 157 may be disposed on the outer surface 159A of the body 159 of the energy delivery member 155. Alternatively, it is envisioned that the energy emitter 157 may extend from within the energy delivery member 155 to the outer surface 159A, or that the energy emitter 157 may be disposed within the energy delivery member 155. For example, the energy emitter 157 may be embedded in a material used in the construction of the energy delivery member 155 such that the energy emitter 157 is disposed radially inward of the outer surface 159A. In such an embodiment, the energy emitter 157 may be exposed through one or more openings (e.g., windows) formed in the outer surface 159A of the body 159.

[0183] In use, the energy delivery member 155 is introduced into the target tissue (e.g., a valve or other such target site) and the energy delivery member 155 expands (inflates). Upon expansion (e.g., to occlude a blood lumen), blood flow is maintained through the passageway 156 extending through the energy delivery member 155. Energy is applied from the energy source E to the energy emitter 157 for a period of time to treat the target tissue. Following treatment, energy transmission to the energy emitter 157 is terminated and the energy delivery member 155 is retracted (e.g., deflated), allowing for removal of the catheter 140. In some embodiments, these balloon inflation and energy delivery steps may be repeated two or more times before removal of the catheter.

[0184] In some embodiments, the energy delivery member 155 expands (e.g., expands) so that the energy emitter 157 comes into contact with the target tissue (e.g., a blood lumen blockage or calcification). In other embodiments, the energy delivery member 155 can be configured such that the energy emitter 157 moves away from (out of contact with) the target tissue after expanding (expanding).

[0185] 12, the catheter body 142 may define a single lumen 141 to allow for passage of a wire, injection of fluid to the target site, expansion and retraction (e.g., inflation and deflation) of the energy delivery member 155, etc. Other embodiments may include a separate dedicated lumen configured to assist in expansion and retraction (e.g., inflation and deflation) of the energy delivery member 155 and may extend to (within) the outer wall of the catheter body 142. As discussed in more detail below, it is contemplated that the catheter body 142 may include multiple energy delivery members 155, each of which may be routed by a separate lumen.

[0186] Catheter 140 may have a filter at its distal end, like the catheters described above.

[0187] The presence of the passages 156 allows the energy delivery member 155 to be continuously expanded (e.g., inflated) in a heart valve, blood vessel, or other area without significantly impeding outflow / blood flow. Without the passages 156, blood flow could be impeded (or completely blocked), which can be detrimental in surgical procedures such as heart valve procedures, especially if blocked for extended periods of time. The bypass catheters disclosed herein (e.g., bypass catheters having a balloon with an energy emitter attached or supported thereto) similarly allow for continuous expansion (e.g., expansion) in a valve, such as a heart valve, a cardiac valve, blood vessel, or other area without significantly impeding outflow / blood flow as blood flows into the side holes and out the distal holes. It is envisioned that the catheters disclosed herein can be used in intravascular or intraluminal ablation procedures to pulverize calcification (e.g., via the above-described energy emitter 157 attached or supported by the energy delivery member 155) while providing a conduit / passageway for blood flow (e.g., via the passages 156). For example, the catheters described herein may be used preoperatively to soften any such calcification.

[0188] During the course of a procedure, blood can flow through the energy delivery member 155 via the passageway 156, but blood flow may be restricted (e.g., due to backflow (retrograde blood flow) from the aorta back into the left ventricle). To address this concern, in alternative embodiments, the catheter 140 may include an energy delivery member 155A ( FIG. 12A ) with a body 159A defining a passageway 156A that contains (supports) a valve 151A to inhibit (if not completely prevent) retrograde blood flow (e.g., backflow) through the energy delivery member 155A (e.g., thereby extending the available time to complete the lithotripsy or other such surgical procedure). In the illustrated embodiment, the valve 151A includes a tricuspid valve configuration with valve leaflets 151Ai, 151Aii, and 151Aiii. However, it should be appreciated that the configuration of the valve 151A may vary in alternative embodiments without departing from the scope of the present disclosure, as described in more detail below.

[0189] Valve 151A, like other valves disclosed herein, can open and close, and in some embodiments, is intermittently open. An open valve allows blood flow through the valve. In some embodiments, a pressure gradient across the valve causes the valve to open.

[0190] The valves disclosed herein can be used to block blood flow during diastole, allowing prolonged therapy without causing cardiac flow symptoms (as blood flow does not have to stop during systole or before patient death).

[0191] FIG. 12B illustrates another embodiment of the present disclosure in which catheter 140 includes a toroidal (or nearly toroidal, torus-shaped) energy delivery member 155B defining an outer surface 158B with a continuous curvature. While energy delivery member 155B is illustrated as including a passageway 156B and a valve 151B with a circular (or nearly circular) cross-sectional configuration (e.g., diameter), it should be appreciated that in alternative embodiments, the specific configurations of passageway 156B and valve 151B may vary without departing from the scope of the present disclosure. For example, FIG. 12C illustrates an alternative embodiment of energy delivery member 155B, identified by reference numeral 155C, including a passageway 156C and a valve 151C with a non-circular (e.g., elliptical) cross-sectional configuration.

[0192] Conceptually, when a valve is stenotic, the outer portions of the valve leaflets adhere, narrowing the remaining opening. When a TAVR (endovascular valve replacement) is performed, this stenotic valve is stretched open using either a balloon or a self-expanding valve. However, if the adhesions are highly calcified, stretching can cause tears in the valve and adjacent tissue and / or the aortic root, which is usually fatal. The catheter of the present invention can be used to soften the calcification by lithotripsy prior to TAVR, thereby protecting against this serious complication. If the balloon (or other such expanding member) is only in a small opening, the contact area for lithotripsy is very limited. In contrast, a larger surface area can reduce calcification, and the catheters of Figures 14-15 achieve this by providing a large surface area for lithotripsy. These catheters have energy emitters attached to balloon portions placed on both sides of the valve.

[0193] More specifically, Figure 15 illustrates a catheter 170 including a catheter body 172 and an energy delivery member 175 attached (or otherwise secured) to the catheter body 172 such that the energy delivery member 175 extends radially outward. In the illustrated embodiment, the energy delivery member 175 is configured as an expandable member (e.g., balloon) 175A having a (generally) cylindrical configuration defining a conduit 176 configured to receive the catheter body 172 so that the catheter body 142 extends therethrough, as shown. The region of the catheter 170 distal to the energy delivery member 175 is indicated by reference numeral 171, and the region of the catheter 170 proximal to the energy delivery member 175 is indicated by reference numeral 173. It should be appreciated that the energy delivery member 175 may be disposed at any suitable location along the catheter body 172. The catheter 170 has a proximal opening 177 and a distal opening 174 that are fluidly connected by a lumen extending within the catheter 170. Port 180 provides for the injection of a fluid (liquid or gas) that expands (eg, inflates) energy delivery member 175 .

[0194] The energy delivery member 175 includes a passageway 178 (e.g., an opening, a duct, a conduit, etc.) that extends parallel (or substantially parallel) to the longitudinal axis X2 defined by the catheter body 172 and that allows blood to flow to the energy delivery member 175 during a surgical procedure (e.g., following dilation). In the particular embodiment shown, the passageway 178 is defined by a tubular member (portion, sleeve) 183 with proximal and distal openings that extend into the energy delivery member 175. The tubular member 183, and therefore the passageway 178, is eccentrically positioned and radially offset from the duct 176 and the center of the energy delivery member 175, such that a majority (e.g., more than 50%) of the tubular member 183 is offset to one side of the longitudinal axis X2 defined by the catheter body 172.

[0195] In some embodiments, as seen in FIG. 15A , catheter 170 can include a valve 179 disposed within passageway 178 (e.g., within tubular member 183). Valve 179 is similar (if not identical) to valve 151 discussed above with respect to FIG. 12A and is configured to inhibit (if not completely prevent) blood flow through energy delivery member 175. For example, as seen in FIG. 15A , valve 179 can be configured to inhibit (if not completely prevent) retrograde blood flow (e.g., backflow) through energy delivery member 175 (e.g., in a proximal direction indicated by arrow 1). However, it is also contemplated that the configuration of valve 179 can be reversed (flipped) such that valve 179 has a configuration that inhibits (if not completely prevent) retrograde blood flow through energy delivery member 175 (e.g., in a distal direction indicated by arrow 2).

[0196] When expanded (inflated), the energy delivery member 175 defines (includes) a first (distal) portion 182, a second (proximal) portion 184, and an intermediate portion 186 disposed between each of the first and second portions 182, 184. The intermediate portion 186 forms a waist or narrow portion with a gap 188 configured to accommodate a target tissue (e.g., a patient's valve) upon expansion (e.g., expansion) of the energy delivery member 175. That is, the lateral dimensions of the intermediate (narrow) portion 186 are smaller than the lateral dimensions of the first and second portions 182, 184. In this manner, each of the first and second portions 182, 184 can be placed on opposite sides of the target tissue, with at least one energy emission surface configured to compress opposite sides of the target tissue (e.g., to treat a valve such as a heart valve) and configured for placement on different sides of the waist, as described below.

[0197] One or more energy emitters 187 are supported by the energy delivery member 175 adjacent its outer surface and are configured to deliver energy to the target tissue to facilitate treatment thereof, as discussed above in connection with the catheter 140 shown in FIG. 12 . In the particular embodiment shown, for example, the energy delivery member 175 includes a plurality of circumferentially extending energy emitters 187. More specifically, the energy delivery member 175 includes an energy emitter 187 supported (disposed) on the second portion 182 to face the first portion 184, and an energy emitter 187 supported (disposed) on the first portion 184 to face the second portion 182. It is envisioned that one or more energy emitters 187 may be provided on each of the first and second portions 182, 184 (at any suitable location).

[0198] The expansion (e.g., swelling) of the energy delivery member 175 brings the energy emitter 187 closer to the target tissue to facilitate delivery of energy during treatment (e.g., to reduce calcification). Like the other energy emitters disclosed above, the energy emitter 177 may emit ultrasonic or other energy at a variety of frequencies.

[0199] A connector 189 (e.g., one or more wires) connects the energy emitter 187 to an external energy source F. The energy emitter 187 may be disposed on (around) the outer wall of the energy delivery member 175. Alternatively, the energy emitter 187 may extend from within the energy delivery member 175 to the outer wall, or the energy emitter 187 may be disposed within (within) the energy delivery member 175. For example, the energy emitter 187 may be embedded in the material used in the construction of the energy delivery member 175. In such embodiments, the energy emitter 187 may be exposed through one or more openings (e.g., windows) defined by the energy delivery member 175.

[0200] It is contemplated that the energy emitters 187 may be arranged in various arrays and spaced variously in various embodiments of the present disclosure to achieve the necessary or desired therapeutic effect (depending on the particular nature and / or location of the abnormality being treated). In the particular embodiment of Figure 15, for example, the energy emitters 187 extend from the connector 189 to define a first (bifurcated) branch 187A having (first and second) legs 187i, 187ii and a second (bifurcated) branch 187B having (third and fourth) legs 187iii, 187iv, with legs 187i, 187iii disposed on the first portion 182 of the energy delivery member 175 and legs 187ii, 187iv disposed on the second portion 184 of the energy delivery member 175. 15, legs 187i, 187ii extend in a first (circumferential) direction and legs 187iii, 187iv extend in a second, opposite (circumferential) direction. In various embodiments of the present disclosure, energy emitter 187 can extend from connector 189 to partially or completely surround energy delivery member 175.

[0201] In some embodiments, the energy delivery member 175 expands (e.g., expands) such that the energy emitter 187 is in contact with the target tissue (e.g., an obstruction or calcification in the lumen of a blood vessel). In other embodiments, the energy delivery member 175 can be configured such that the energy emitter 187 moves away from (out of contact with) the target tissue after expanding (e.g., expanding).

[0202] In use, the energy delivery member 175 is introduced into a target tissue (e.g., a valve or other such target site) and the energy delivery member 175 expands (e.g., inflates). Upon expansion, the energy delivery member 175 is positioned such that the second portion 182 is adjacent to (e.g., in contact with) a first (distal) side of the target tissue and the first portion 184 is adjacent to (e.g., in contact with) a second (e.g., proximal) side of the target tissue such that the energy delivery member 175 straddles (straddles) the target tissue and the waist formed by the intermediate portion 186 accommodates the target tissue (e.g., the valve orifice and / or leaflets are disposed within the gap 188). In some embodiments, the energy delivery member 175 can be configured such that each of the first and second portions 182, 184 can be spaced (e.g., axially) from the target tissue (e.g., the sides and / or leaflets of the valve). Alternatively, the energy delivery member 175 may be configured such that each of the first and second portions 182, 184 may be in contact with the target tissue (e.g., the sides and / or leaflets of the valve). For example, the energy delivery member 175 may be configured such that each of the first and second portions 182, 184 forms an abutment surface that presses against the sides of the valve (e.g., the leaflets).

[0203] During use of the catheter 170, energy is applied to the target tissue via the energy emitter 187 for a period of time following expansion (e.g., inflation) of the energy delivery member 175. The configuration of the energy delivery member 175 and the orientation of the energy emitter 187 increase the surface area of ​​the target tissue contacted by the energy delivery member 175. For example, in the context of a calcified valve, the increased surface area contacted by the energy delivery member 175 significantly reduces the burden of brittle calcification on the valve and surrounding tissue. Upon expansion (e.g., inflation), the energy delivery member 175 may occlude the vessel lumen, yet blood flow is maintained through the passageway 178 of the energy delivery member 175.

[0204] Following treatment, energy transmission to the energy emitter 187 is stopped and the energy delivery member 175 is retracted (e.g., contracted), thus allowing removal of the catheter 170. In some embodiments, these steps of energy emission and expansion may be repeated two or more times.

[0205] 14, another embodiment of a catheter will be discussed, identified by the reference numeral 190. Catheter 190 includes a catheter body 191 having an energy delivery member 195 and a (primary working) lumen 193 extending therethrough and configured to accommodate one or more ancillary medical implements (e.g., catheters, instruments, tools, etc.).

[0206] An energy delivery member 195 is supported (e.g., attached or otherwise secured) to the catheter body 191 such that the energy delivery member 195 extends radially outward and is substantially similar to the energy delivery member 175 ( FIG. 15 ) described above. More specifically, when expanded (e.g., inflated), the energy delivery member 195 defines a cylindrical (or generally cylindrical) configuration and includes a first (distal) portion 192 defining a (distal) end face 192A that is a planar (or generally planar) configuration, a second (proximal) portion 194 defining a (proximal) end face 194A that is a planar (or generally planar) configuration, and an intermediate portion 196 disposed between the first and second portions 192, 194. However, it should be appreciated that alternative configurations of the energy delivery member 195 are contemplated herein, as described in more detail below.

[0207] The intermediate portion 196 forms a waist or narrow portion with a gap 198 configured to accommodate the target tissue (e.g., a patient's valve). That is, the lateral dimension of the intermediate (narrow) portion is smaller than the lateral dimensions of the first portion 192 and the second portion 194. In this manner, each of the first and second portions 192, 194 can be placed on either side of the target tissue (e.g., a valve leaflet) in a manner similar to the energy delivery member 175.

[0208] In the particular embodiment illustrated in FIG. 14 , the energy delivery member 195 is centrally disposed (concentrically mounted) relative to the longitudinal axis X3 defined by the body 193 of the catheter 190. However, it is contemplated that the energy delivery member 195 may be eccentrically disposed (e.g., such that the center of the energy delivery member 195 is radially offset from the longitudinal axis X3). In contrast to the catheter 170, the catheter 190 is configured and functions as a bypass catheter (similar to that illustrated in FIG. 1 ) in that the energy delivery member 195 lacks a blood flow passageway (e.g., the passageway 178 discussed above). Instead, the catheter body 191 includes a side hole 199 a and a distal end hole 199 b (which may be similar or identical to the side hole 2 and end hole 4 ( FIG. 1 ) described above, respectively) that facilitate blood flow through the catheter body 191 and out the distal end hole 199 b in the same manner as the bypass catheters described herein.

[0209] Energy delivery member 195 is similar or identical to energy emitter 187 discussed above in connection with catheter 170 (FIG. 15) and includes an energy emitter 197 in communication with an external energy source F via connector 197a. Energy emitter 197 is constructed and arranged to direct energy into gap 198 upon receipt of target tissue to facilitate treatment thereof. More specifically, energy delivery member 195 includes energy emitters 197i, 197ii supported on / by second portion 194 to face first portion 192, and energy emitters 197iii, 197iv supported on / by first portion 192 to face second portion 194, such that energy emitters 197i, 197ii and energy emitters 197iii, 197iv face in opposite (or substantially opposite) directions.

[0210] Catheter 190 and energy delivery member 195 are used in a manner similar to catheter 170 ( FIG. 15 ) and energy delivery member 175 for placement relative to a target tissue (e.g., a heart valve). However, in contrast to catheter 170, during use of catheter 190, blood flows from side holes 199 a (through catheter body 191) to distal holes 199 b, rather than through energy delivery member 195 itself, which also reduces (if not completely eliminates) significant flow obstruction upon expansion (e.g., inflation) of energy delivery member 195. Energy emitters 197 iii, 194 iv (as in the energy emitters of FIGS. 14A-16A ) are on the proximal-facing surface of distal portion 192 opposite distal-facing surface 192A, and energy emitters 197 i, 197 ii (as in the energy emitters of FIGS. 14-16A ) are on the distal-facing surface of proximal portion 194 opposite proximal-facing surface 194A.

[0211] 14A illustrates an alternative embodiment of a (bypass) catheter 190 that includes a valve 185 disposed (positioned, supported) within a lumen 193 defined by a catheter body 191 (e.g., to sealingly house an auxiliary medical device M and / or to prevent blood flow through the catheter 190). In all other respects, the catheter of FIG. 14A is identical to the catheter of FIG. 14. While illustrated as being disposed proximate (or generally proximate) to the energy delivery member 195 (e.g., such that the energy delivery member 195 sandwiches the valve 185), it should be appreciated that the specific location of the valve 185 can vary in various embodiments without departing from the scope of the present disclosure. For example, as discussed in more detail below, embodiments are contemplated herein in which the valve 185 can be disposed proximal or distal to the energy delivery member 195.

[0212] 14B illustrates another embodiment of a (bypass) catheter 190 in which an energy delivery member 195 includes a passageway 181 and the valve 179 described above. To accommodate the inclusion of the passageway 181, a gap 198 defined by an intermediate portion 196 of the energy delivery member 195 is shortened, defining a smaller radial dimension (length) (e.g., when compared to the embodiment of the catheter 190 shown in FIGS. 14 and 14A).

[0213] Valve 179 is disposed within passageway 181 and configured to inhibit (if not completely prevent) blood flow through energy delivery member 195. In certain embodiments of the present disclosure, as shown in FIG. 14B , valve 179 is configured to inhibit (if not completely prevent) retrograde (e.g., backflow) blood flow through energy delivery member 195 (e.g., in a proximal direction indicated by arrow 1). However, as shown in FIG. 14C , the configuration of valve 179 can be reversed (flipped), such that valve 179 is configured to inhibit (if not completely prevent) antegrade (e.g., backflow) blood flow through energy delivery member 195 (e.g., in a distal direction indicated by arrow 2).

[0214] 14B, the energy delivery member 195 is eccentrically mounted such that the energy delivery member 195 and the passageways 181 are each radially offset (out of alignment) from the longitudinal axis X3 defined by the catheter body 191 (e.g., such that a majority (greater than 50%) of the energy delivery member 195 and the passageways 181 are eccentrically disposed relative to and offset to one side of the longitudinal axis X3). However, embodiments are also contemplated in which the energy delivery member 195 may be concentrically disposed about the catheter body 191 while the passageways 181 remain radially offset from the longitudinal axis X3.

[0215] 14D , during use, the catheter 190 is advanced through an access vessel A (e.g., a patient's aorta) via a femoral or radial approach to a target tissue (e.g., a patient's heart valve C) until a distal portion 192 of the energy delivery member 195 is positioned distally of the target tissue and a proximal portion 194 of the delivery member 195 is positioned proximal to the target tissue. When so positioned, the target tissue (e.g., the leaflets Li, Lii of the heart valve C) is contained within a gap 198 ( FIG. 14B ) defined by an intermediate portion 196 of the energy delivery member 195 such that the energy emitter 197 is positioned proximal (or near proximal) to (e.g., in contact with) the target tissue. Energy is transferred from an external energy source F to the target tissue via the connector 197 a and the energy emitter 197 to treat the target tissue (e.g., soften any calcification at the leaflets Li, Lii).

[0216] When catheter 190 is positioned in the manner illustrated in FIG. 14D , its distal region 191 a sandwiches (extends distally beyond) the target tissue, allowing blood to bypass the target tissue through distal region 191 a (depending on the direction of blood flow). For example, it is contemplated that blood may flow through side hole 199 a and distal region 191 a and exit through distal end hole 199 b, or blood may flow through distal end hole 199 b and distal region 191 a and exit through side hole 199 a. Catheter 190 may be configured such that its proximal end is positioned outside the patient (e.g., to allow for aspiration of debris, mass, etc.), thereby preventing proximal region 191 b of catheter 190 from participating in the bypass procedure. Note that side hole 199 a (and other side holes for blood flow in other catheters disclosed herein) may be positioned in catheter portions other than those shown in FIG. 14D .

[0217] In some uses, when side hole 199a is covered (e.g., by access vessel A or other section of patient tissue), the bypass is closed and blood does not flow through catheter 190. However, to establish blood flow, blood can be backbleed or actively aspirated from the body (e.g., through the proximal end of catheter 190).

[0218] Figure 14E illustrates another embodiment of a (bypass) catheter 190 in which the energy delivery member 195 includes a valve 179A. In contrast to the valve 179 seen in Figures 14B and 14C, which includes a tricuspid valve configuration defining cusps 179i, 179ii, and 179iii that are similar (if not identical) to the valve 151 discussed above with respect to Figure 12A, valve 179A includes a bicuspid valve configuration defining cusps 179Ai and 179Aii.

[0219] Figure 16 illustrates another embodiment of the presently disclosed (bypass) catheter, identified by the reference numeral 200. The catheter 200 includes a catheter body 202 defining a longitudinal axis X4, a (primary working) lumen 203 configured to accommodate one or more ancillary medical devices (e.g., catheters, instruments, tools, etc.) M (Figure 14A), a distal energy delivery member 205, and a proximal energy delivery member 207. The energy delivery members 205, 207 are arranged in a combined configuration such that they define a space (gap) 208 therebetween and are centrally disposed within (concentrically attached to) the catheter body 202.

[0220] During use of the catheter 200, the distal energy delivery member 205 is positioned on one side of a target tissue (e.g., a valve leaflet), and the proximal energy delivery member 207 is positioned on the other side of the target tissue. As discussed above, for example, in connection with FIG. 15 , a space (gap) 208 is formed by the axial spacing of the energy delivery members 205, 207, rather than by a narrow portion. Each of the energy delivery members 205, 207 includes one or more energy emitters 211 that are connected to an external energy source F by a connector 213. The energy emitters 211 are disposed in an opposing relationship such that the energy emitter 211 included in the energy delivery member 205 is oriented (facing) toward the energy delivery member 207, and such that the energy emitter 211 included in the energy delivery member 207 is oriented (facing) toward the energy delivery member 205. Catheter 200 functions in the same manner as catheter 190 described above with respect to the placement of energy delivery members 205, 207 (one on each side of the valve) and blood flow through catheter 200. More specifically, blood flows through side holes 206, a lumen 203 defined by catheter body 202, and distal end hole 209.

[0221] As discussed above with respect to catheter 170 (FIG. 15), it is envisioned that the energy emitters 211 may be arranged in a variety of arrays and spaced apart in a variety of ways to achieve any necessary or desired therapeutic effect (e.g., depending on the particular nature and / or location of the abnormality being treated). In the particular embodiment of the disclosure seen in FIG. 16, for example, the energy emitters 211 extend from the connector 213 to define a first (distal) branch 211A (continuous and non-bifurcated) that extends (either partially or completely) circumferentially about the energy delivery member 205, and a second (proximal) branch 211B (continuous and non-bifurcated) that extends (either partially or completely) circumferentially about the energy delivery member 207.

[0222] It should be noted that shapes other than those discussed in connection with the energy delivery members described above may be utilized to treat target tissue (eg, valves) as described above.

[0223] It is envisioned that the energy delivery members 175, 195, 205, etc. may alternatively have a figure-eight configuration.

[0224] It should be noted that although the catheters of Figures 15-16 are described for use in valves, such as heart valves, they may be used to treat other areas / tissues of a patient while maintaining blood flow.

[0225] In some embodiments of the devices disclosed herein, blood may flow through the device in the opposite direction when the device is introduced via a retrograde "upstream" approach. This is depicted, for example, in FIG. 13 , where blood may flow distally from the catheter's distal opening 167 and out side holes 162 and / or proximal holes 163. The catheter 160 may include an energy delivery member 166 (e.g., a balloon or other such expanding structure), and as in the embodiments described above, the energy emitter is connected to an external energy source E via wire 164. The catheter 160 may also include a filter 168, as in the embodiments described above, proximal or distal to the energy emitter.

[0226] 16A illustrates another embodiment of a (bypass) catheter 200 in which the distal energy delivery member 205 and the proximal energy delivery member 207 are configured as separate (distinct) structures spaced axially from one another along a longitudinal axis X4 defined by the catheter body 202 to define a space (gap) 208. The energy delivery members 205, 207 define (first and second) passages 215, 217, respectively, that are similar (if not identical) to the passages 156 (FIGS. 12, 12A), 181 (FIG. 14B) described above.

[0227] In the particular embodiment of FIG. 16A , the energy delivery members 205, 207 are eccentrically mounted such that the energy delivery members 205, 207 and the passageways 215, 217 are each radially offset (out of alignment) from the longitudinal axis X4 defined by the catheter body 202 (e.g., such that a majority (more than 50%) of the energy delivery members 205, 207 and the passageways 215, 217 are offset to one side of the longitudinal axis X4). However, embodiments are also contemplated in which the energy delivery members 205, 207 may be concentrically disposed about the catheter body 202 while the passageways 215, 217 remain radially offset from the longitudinal axis X3.

[0228] 16A, the energy delivery members 205, 207 are configured such that the passageways 215, 217 are oriented in (general) radial alignment to facilitate blood flow through the energy delivery members 205, 207. More specifically, in the particular embodiment shown, the energy delivery members 205, 207 are configured to allow antegrade blood flow (e.g., in a distal direction indicated by arrow 2), while retrograde blood flow (e.g., backflow in a proximal direction indicated by arrow 1) is impeded (if not entirely prevented) by a valve 219 disposed in the passageway 217 extending through the energy delivery member 207 and similar (if not identical) to valves 151 (FIG. 12A), 179 (FIGS. 14B, 14C). In alternative embodiments of the present disclosure, the configuration of valve 219 may be reversed (flipped) such that valve 219 is configured to impede (if not completely prevent) antegrade blood flow (e.g., in the distal direction indicated by arrow 2) through energy delivery member 205, 207, and / or valve 219 may instead be disposed within passage 215 extending to energy delivery member 205.

[0229] Figure 17 illustrates another embodiment of a (bypass) catheter, identified by the reference numeral 300. Catheter 300 is substantially similar to catheter 190 (Figure 14), and therefore, for the sake of brevity, will be discussed only with respect to any differences. Therefore, the same reference numerals will be used to refer to elements, structures, features, etc. common to catheters 190 and 300.

[0230] In contrast to catheter 190, catheter 300 includes an energy delivery member 302 having a toroidal (or near-toroidal, torus configuration) defining an outer surface 304 with a continuous curvature. The energy delivery member 302 includes (defines) a conduit 306 configured to receive the catheter body 191 such that the catheter body 191 extends therethrough. In the particular embodiment shown, the energy delivery member 302 is centrally disposed (concentrically attached) to the catheter body 191. However, it is contemplated that the energy delivery member 302 may be eccentrically disposed (e.g., such that the conduit 306 is radially offset from the longitudinal axis X3 defined by the catheter body 191).

[0231] In the illustrated embodiment, the energy delivery member 302 includes a single energy emitter 197 disposed on (or adjacent to) the outer surface 304 of the delivery member 302. However, it should be appreciated that in alternative embodiments, the number of energy emitters 197 included in the energy delivery member 302 may vary without departing from the scope of the present disclosure. Additionally, while illustrated in FIG. 17 as completely surrounding the energy delivery member 302, it should be appreciated that the particular configuration of the energy emitter 197 may vary in alternative embodiments without departing from the scope of the present disclosure. For example, embodiments in which the energy emitter 197 only partially surrounds the energy delivery member 302 are also contemplated herein.

[0232] Figure 18 illustrates another embodiment of a (bypass) catheter, identified by the reference numeral 400. Catheter 400 is substantially similar to catheters 190 (Figure 14) and 300 (Figure 17), and therefore, for the sake of brevity, will be discussed only with respect to any differences. Therefore, the same reference numerals will be used to refer to elements, structures, features, etc. common to catheters 190, 300, and 400.

[0233] The catheter 400 includes a pair of energy delivery members 402, 404 oriented in proximate (e.g., side-by-side, stacked) relationship to define a cascade (or near-cascade) configuration. While shown as coupled in the particular embodiment illustrated in Figure 18, it should be appreciated that in alternative embodiments, the energy delivery members 402, 404 may be configured as separate (discrete) structures without departing from the scope of the present disclosure.

[0234] Each of the energy delivery members 402, 404 includes a toroidal (or substantially toroidal, torus configuration) similar (if not identical) to that discussed in connection with the energy delivery member 302 ( FIG. 17 ). More specifically, the energy delivery members 402, 404 include bodies 406, 408, each defining an outer surface 410, 412 and including passageways 414, 416 that extend in a parallel (or substantially) parallel relationship to the longitudinal axis X3 defined by the catheter body 191. In some embodiments, as shown in FIG. 18 , the energy delivery members 402, 404 can include valves 418, 420, similar (if not identical) to the valves 151 ( FIG. 12A ), 151B ( FIG. 12B ), and 179 ( FIG. 14B ) described above, disposed within the passageways 414, 416, respectively. Valves 418, 420 may be configured to inhibit (if not completely prevent) antegrade blood flow (e.g., retrograde flow) in each energy delivery member 402, 404 (e.g., in a proximal direction indicated by arrow 1), or the configuration of valves 418, 420 may be reversed (flipped) such that valves 418, 420 are configured to inhibit (if not completely prevent) antegrade blood flow through energy delivery members 402, 404 (e.g., in a distal direction indicated by arrow 2).

[0235] 18, each of the energy delivery members 402, 404 is eccentrically supported by the catheter body 191 (e.g., such that the passages 414, 416 and valves 418, 420 are radially offset from the longitudinal axis X3). To facilitate connection (attachment) to the catheter body 191, the energy delivery members 402, 404 together define a conduit 422 configured to receive the catheter body 191 so that the catheter body 191 extends therethrough.

[0236] In the illustrated embodiment, the catheter 400 includes a single energy emitter 197 disposed on (proximate) each outer surface 410, 412 of the body 406, 408 of the energy delivery member 402, 404. However, it should be appreciated that in alternative embodiments, the number of energy emitters 197 may vary without departing from the scope of the present disclosure. For example, each energy delivery member 402, 404 may support (include) a separate energy emitter 197. Additionally, while illustrated in FIG. 18 as completely surrounding the outer surfaces 410, 412, it should be appreciated that the specific configuration of the energy emitter 197 may vary in alternative embodiments. For example, embodiments in which the energy emitter 197 only partially surrounds the outer surfaces 410, 412 are also contemplated herein.

[0237] Referring to Figure 19, another embodiment of a (bypass) catheter, identified by reference numeral 500, will be discussed. Catheter 500 includes an energy delivery member 502 and is substantially similar to catheters 190 (Figure 14), 300 (Figure 17), and 400 (Figure 18), except for the configuration of energy delivery member 502. Accordingly, catheter 500 will be discussed for brevity only with respect to any differences from catheters 190, 300, and 400, and the same reference numerals will be used to refer to elements, structures, features, etc. common to catheters 190, 300, 400, and 500.

[0238] The energy delivery member 502 is supported by (e.g., attached or otherwise secured to) the catheter body 191 so that the energy delivery member 502 extends radially outward. In contrast to the energy delivery members described above (e.g., energy delivery member 155 (FIGS. 12, 12A), energy delivery member 195 (FIGS. 14-14E), energy delivery member 175 (FIGS. 15-15, 15A), etc.), the energy delivery member 502 is non-expandable, which may simplify the construction of the catheter 500 by eliminating the need for an inflation lumen and allowing for a reduction in the overall size and / or cost of the catheter body 191. While the catheter 500 is illustrated as including a single energy delivery member 502, it should be appreciated that the number of energy delivery members 502 may be increased in alternative embodiments of the present disclosure, as discussed in more detail below. For example, it is contemplated that the catheter 500 may include two energy delivery members 502, three energy delivery members 502, etc. Additionally, although in the particular embodiment shown in FIG. 19 the energy delivery member 502 is shown as being fixedly supported (connected) to the catheter body 191, in alternative embodiments the energy delivery member 502 may be movably (e.g., slidably) supported (connected) to the catheter body 191, as discussed in more detail below.

[0239] The energy delivery member 502 comprises a deformable (or flexible) material that allows for elastic reconfiguration (e.g., bending, compressing, etc.) of the energy delivery member 502 during insertion and removal of the catheter 500. More specifically, the energy delivery member 502 comprises a disc-like configuration that defines an annular (or approximately annular) cross-sectional configuration (e.g., diameter) and respective proximal and distal end faces 504, 506. While illustrated as circular (or approximately circular) in the particular embodiment seen in FIG. 19 , it should be appreciated that alternative configurations of the energy delivery member 502 are contemplated herein. For example, it is contemplated that the energy delivery member 502 may include a cross-sectional configuration that is elliptical (or approximately elliptical), beaded (or approximately beaded), etc. Additionally, while the end faces 504, 506 of the energy delivery member 502 are depicted as planar (or substantially planar) in the particular embodiment of the present disclosure illustrated in Figure 19, it should be appreciated that the specific configuration of the end faces 504, 506 may vary in alternative embodiments of the disclosure. For example, embodiments are contemplated herein in which either or both of the end faces 504, 506 may include an arcuate (e.g., concave or convex) configuration.

[0240] In the particular embodiment shown, the energy delivery member 502 is centrally disposed (concentrically mounted) relative to a longitudinal axis X3 defined by the catheter body 191. More specifically, the energy delivery member 502 includes a passageway 508 configured to receive the catheter body 191 such that the catheter body 191 extends (both proximally and distally) into the energy delivery member 502. However, as described in more detail below, it is also contemplated that the energy delivery member 502 may be eccentrically disposed (e.g., such that the center of the energy delivery member 502 is radially offset from the longitudinal axis X3).

[0241] The energy delivery member 502 is in communication with an external energy source F via a connector 197a and includes (supports) one or more energy emitters 197 similar or identical to the energy emitters 157, 187, 197, etc., described above. The energy emitters 197 are supported by the energy delivery member 502 so as to be disposed on (proximate) the end face 504 and / or end face 506 and extend around (centered about) the passageway 508 in a non-linear (e.g., torus) configuration. In the particular embodiment shown, for example, the energy emitters 197 are disposed on (proximate) the outer surfaces of the end faces 504, 506 and are directed in opposite (or generally opposite) directions. However, as discussed in connection with previous embodiments of the present disclosure, it is contemplated that the energy emitters 197 may be arranged in various arrays and spaced apart in any manner suitable for the intended purpose of delivering energy to the target tissue to facilitate treatment in the manner described herein. For example, the energy emitter 197 may extend either partially or completely around the outer periphery 510 (e.g., circumferentially or radially outwardly) of the energy delivery member 502 (e.g., depending on the particular configuration, location, etc. of the target tissue being treated), and / or the energy emitter 197 may extend within the energy delivery member 502 to the end faces 504, 506 (e.g., in a linear or generally linear configuration). The energy emitter 197 may alternatively be disposed internally within the energy delivery member 502 (e.g., embedded in a material used in the construction of the energy delivery member 502 such that the energy emitter 197 is disposed radially inward of the end faces 504, 506). In such an embodiment, the energy emitter 197 may be exposed through one or more openings (e.g., windows) formed in the end faces 504, 506. In an alternative embodiment, the energy emitter may be disposed on only one of the end faces 504, 506.

[0242] Figure 19A illustrates another embodiment of a (bypass) catheter, identified by reference numeral 500A. Catheter 500A includes an energy delivery member 502A and is substantially similar to catheter 500 (Figure 19) except for energy delivery member 502A, and therefore, for the sake of brevity, will only be discussed with respect to any differences. Therefore, the same reference numerals will be used to refer to elements, structures, features, etc. common to catheters 500 and 500A.

[0243] The energy delivery member 502A defines respective proximal and distal end faces 504A, 506A and includes a passageway 508A and a valve 509A. The valve 509A is similar (if not identical) to the valves 151 (FIGS. 12, 12A) and 179 (FIG. 15) described above and is disposed (supported) within the passageway 508A so that the catheter body 191 extends (both proximally and distally). While illustrated as centrally located in the particular embodiment shown in FIG. 19A, it is contemplated that the passageway 508A and valve 509A may be eccentrically located (e.g., so that the passageway 508A and valve 509A are radially offset from the center of the energy delivery member 502A and the longitudinal axis X3 defined by the catheter body 191).

[0244] In contrast to the energy delivery member 502 included in the catheter 500, in which the passageway 508 defines a cross-sectional dimension (e.g., diameter) substantially approximating that defined by the catheter body 191, the passageway 508A extending through the energy delivery member 502A defines a cross-sectional dimension (e.g., diameter) D0 that substantially exceeds that defined by the catheter body 191 and identified by reference character D. For example, it is contemplated that the cross-sectional dimension D0 may substantially fall within a range of approximately 125% to approximately 500% of the cross-sectional dimension D.

[0245] The energy delivery member 502A includes (supports) one or more of the aforementioned energy emitters 197, which in the illustrated embodiment are disposed on (proximate) the end faces 504A, 506A and extend concentrically around (centered about) the passageway 508A. While the particular embodiment shown in FIG. 19A is illustrated as including a single energy emitter 197 on each of the end faces 504A, 506A, it is contemplated that alternative embodiments may include more or fewer energy emitters 197. For example, embodiments including one or more energy emitters 197 on only the end face 506A or only the end face 504a are also contemplated herein, as are embodiments including two or more energy emitters 197 on each of the end faces 504A, 504B, and embodiments in which one of the end faces 504A, 504B may lack an energy emitter 197. As discussed in connection with the previous embodiments, the energy emitters 197 may be arranged and spaced in various arrays in any manner suitable for the intended purpose of transmitting energy to the target tissue to facilitate treatment in the manner described herein. For example, it is contemplated that the energy emitters 197 may extend around the periphery 510A (e.g., the periphery or radially outermost surface) of the energy delivery member 502A.

[0246] In certain embodiments, such as that illustrated in FIG. 19A , the catheter 500A can include one or more braces 512 (e.g., struts 514) configured to support and / or stabilize the energy delivery member 502A. For example, in FIG. 19A , the catheter 500A includes a pair of (first) proximal struts 514 a, 514 ib and a pair of (second) distal struts 514 i, 514 iib that extend between (e.g., are secured to or otherwise connected to) the catheter body 191 and the energy delivery member 502A. However, it should be appreciated that the specific number and / or configuration of the struts 514 can vary in various embodiments. For example, embodiments including a single proximal strut 514 i and a single distal strut 514 ii are also contemplated herein, as are embodiments including three or more proximal struts 514 i and three or more distal struts 514 ii. Additionally, although the struts 514 are shown as being attached (connected) to the outer periphery 510A of the energy delivery member 502A, the struts 514 may alternatively or additionally be attached (connected) to the end faces 504A, 506A.

[0247] Figure 20 illustrates another embodiment of (bypass) catheter 500, identified by reference numeral 600. Catheter 600 is substantially similar to catheter 500 (Figure 19), and therefore, for the sake of brevity, will be discussed only with respect to any differences. Therefore, the same reference numerals will be used to refer to elements, structures, features, etc. that are common to catheters 500 and 600.

[0248] The catheter 600 includes an alternative embodiment of the energy delivery member 502, identified by reference numeral 602. The energy delivery member 602 is substantially similar to the energy delivery member 502, except that the energy delivery member 602 includes an aperture 612 (or other such opening) extending therethrough. The aperture 612 includes (or otherwise supports) a valve 614 that is similar (if not identical) to the valves 151 (FIGS. 12, 12A), 179 (FIG. 15) described above. It should be appreciated that while the aperture 612, and thus the valve 614, are illustrated as being concentrically disposed (e.g., centered or generally centered about the energy delivery member 602), in alternative embodiments, they may be eccentrically disposed (e.g., such that the aperture 612 and valve 614 are radially offset from the center of the energy delivery member 602).

[0249] In the embodiment of FIG. 20, the energy delivery member 602 defines a (first) cross-sectional dimension (e.g., diameter) D1, while the aperture 612 (and valve 614) defines a (second) cross-sectional dimension (e.g., diameter) D2 that is substantially within a range of about 10% to about 30% of the cross-sectional dimension D1. However, it should be appreciated that the ratio between the cross-sectional dimensions D1 and D2 may vary in various embodiments. For example, FIG. 20a illustrates an embodiment of a catheter 600 in which the cross-sectional dimension D2 defined by the aperture 612 (and valve 614) is substantially within a range of about 40% to about 90% of the cross-sectional dimension D1. (Otherwise, the device of FIG. 20A is the same as that of FIG. 20 and may optionally include side holes for blood inflow.)

[0250] 20 , the energy delivery member 602 is eccentrically mounted to the catheter body 191 such that each of the energy delivery member 602, aperture 612, and valve 614 is radially offset (out of alignment) from the longitudinal axis X3 defined by the catheter body 191 (e.g., such that a majority (greater than 50%) of the energy delivery member 602, aperture 612, and valve 614 are offset to one side of the longitudinal axis X3). However, embodiments are also contemplated in which the energy delivery member 602 may be eccentrically disposed about the catheter body 191, but the aperture 612 and valve 614 remain radially offset from the longitudinal axis X3.

[0251] Valve 614 is configured to inhibit (if not completely prevent) retrograde blood flow (e.g., backflow) through the energy delivery member 602 (e.g., in a proximal direction indicated by arrow 1). However, it is also contemplated that the configuration of valve 614 may be reversed (flipped) such that valve 614 is configured to inhibit (if not completely prevent) antegrade blood flow through the energy delivery member 602 (e.g., in a distal direction indicated by arrow 2).

[0252] It should be appreciated that while the catheter 600 is illustrated as including a single energy delivery member 602 in the particular embodiment shown in Figure 20, in alternative embodiments the number of energy delivery members 602 may be increased. Additionally, while the energy delivery member 602 is illustrated as being fixedly supported (connected) to the catheter body 191 in the particular embodiment shown in Figure 20, in alternative embodiments the energy delivery member 602 may be movably (e.g., slidably) supported (connected) to the catheter body 191, as discussed in more detail below.

[0253] FIG. 21 illustrates an alternative embodiment of a (bypass) catheter 600 including a proximal (first) energy delivery member 602a and a second (distal) energy delivery member 602b, each of which is substantially similar (if not identical) to the energy delivery member 602 (FIG. 20). While illustrated as including a pair of (identical or substantially identical) energy delivery members 602, it should be appreciated that in alternative embodiments, the number of energy delivery members 602 may be increased, such that the catheter 600 includes three energy delivery members 602, four energy delivery members 602, etc. Embodiments are also contemplated in which the energy delivery members 602a, 602b may not be similar in size, shape, flow restriction, etc. For example, embodiments are also contemplated in which only one of the energy delivery members 602 (e.g., energy delivery member 602b) includes a valve 614.

[0254] The energy delivery members 602a, 602b are axially spaced apart from one another along a longitudinal axis X3 defined by the catheter body 191 to define a receiving space (chamber) 616. The receiving space 616 is configured to contain (accommodate) a target tissue (e.g., a patient's (calcified) heart valve C ( FIG. 14D )) such that the energy delivery members 602a, 602b are disposed on either side of the target tissue. The energy delivery members 602a, 602b may be configured and / or disposed along the catheter body 191 such that either or both of the energy delivery members 602a, 602b contact the target tissue during a surgical (e.g., lithotripsy) procedure. When so disposed, the energy emitter 197 is positioned in close proximity (or generally in close proximity) to the target tissue (e.g., such that the energy emitter 197 is in contact).

[0255] 21, the energy delivery member 602a includes an energy emitter 197i oriented (facing) toward the energy delivery member 602b, and the energy delivery member 602b includes an energy emitter 197ii oriented (facing) toward the energy delivery member 602a, such that the energy emitters 197i, 197ii face in opposite (or substantially opposite) directions. As discussed in connection with the previous embodiment, the energy emitters 197 may be arranged and spaced in various arrays in any manner suitable for the intended purpose of delivering energy to the target tissue to facilitate treatment in the manner described herein.

[0256] While the energy delivery members 602a, 602b are depicted in the embodiment shown in FIG. 21 as being fixedly supported (connected) to the catheter body 191, in alternative embodiments, one or more of the energy delivery members 602a, 602b may be movably (e.g., slidably) supported (connected) to the catheter body 191 to change the configuration of the containment space 616 (e.g., depending on the particular configuration, location, etc. of the target tissue being treated) and adjust the distance from, degree of contact with, pressure on, etc., of the tissue provided by the energy delivery members 602a, 602b. For example, FIG. 21A depicts an embodiment in which the energy delivery member 602b is fixedly supported (connected) to the catheter body 191, while the energy delivery member 602a is movable relative thereto via a pusher 618. In such an embodiment, the pusher 618 may be disposed external to the catheter body 191, as depicted in FIG. 21A. The pusher 618 may extend into (or be embedded in) the wall of the catheter body 191 and extend into the (primary working) lumen 193, or the catheter body 191 may include a separate (distinct) lumen configured to accommodate the pusher 618. As illustrated in FIG. 21B , embodiments are also contemplated herein in which each of the energy delivery members 602a, 602b may be movable relative to the catheter body 191 (e.g., via a corresponding pusher 618a, 618b). The pusher 618a induces axial movement of the delivery member 602a, and the pusher 618b induces axial movement of the delivery member 602b, allowing a clinician to selectively adjust the distance between the energy delivery members 602a, 602b to adjust the distance to the target tissue and the degree and force of contact with the target tissue disposed in the gap between the energy delivery members 602a, 602b.

[0257] Figure 22 illustrates another embodiment of a (bypass) catheter, identified by the reference numeral 700. Catheter 700 is substantially similar to catheter 190 (Figs. 14, 14A), and therefore, for the sake of brevity, will be discussed only with respect to any differences therebetween. Therefore, the same reference numerals will be used to refer to elements, structures, features, etc. that are common to catheters 190 and 700.

[0258] The catheter 700 includes a circulatory flow device 702 rotatably disposed within the catheter body 191 to induce blood flow therein. Depending on the particular direction of rotation of the circulatory flow device 702, the circulatory flow device 702 may be configured for unidirectional or bidirectional rotation to induce blood flow within the catheter body 191, for example, in a proximal direction through a valve (indicated by arrow 1) and / or a distal direction (indicated by arrow 2). In the particular embodiment shown in FIG. 22 , the circulatory flow device 702 is illustrated as an impeller 704 including a shaft 706 supporting a head 706 with a plurality of vanes (blades) 708 extending radially outward, although it should be recognized that other configurations of the circulatory flow device 702 are contemplated and that the circulatory flow device 702 may include (or be configured as) any member or structure suitable for its intended purpose of inducing blood flow in the catheter body 191 in the manner described herein. Further details regarding the circulation device 702 (and embodiments thereof) are provided in U.S. Patent Application No. 16 / 881,727, the entire contents of which are incorporated herein by reference. The motor for operating the circulation device may be external to the catheter, or alternatively, located within the catheter and powered by a battery or external plug.

[0259] Although the circulatory flow device 702 is shown as extending within (through) the (primary working) lumen 193 of the embodiment of FIG. 22 , the catheter body 191 may alternatively include separate lumens for the circulatory flow device 702 and the auxiliary medical device M. For example, FIG. 22A illustrates an embodiment in which the catheter body 191 includes a (first) lumen 193 i configured to house (or otherwise accommodate) the circulatory flow device 702 and a (second) lumen 193 ii extending parallel (or substantially parallel) to lumen 193 i and configured to house (or otherwise accommodate) the auxiliary medical device M. It is also contemplated in embodiments of the present disclosure that the circulatory flow device 702 and the auxiliary medical device M may be housed within the same lumen, such as lumen 193 ( FIG. 22 ). In such an embodiment, the catheter body 191 and circulatory flow device 702 may be configured such that the circulatory flow device 702 is rotatable about (or about) the auxiliary medical device M.

[0260] Figure 23 illustrates another embodiment of a (bypass) catheter, identified by the reference numeral 800. Catheter 800 is substantially similar to catheter 140 (of Figure 12B) in that the energy delivery members are of the same configuration. However, it differs from Figure 12B in that it includes a circulatory flow device 802 that enhances distal and / or proximal flow in the same manner as circulatory flow device 702 of Figures 22 and 22A. Therefore, for the sake of brevity, catheter 800 will be discussed only with respect to any differences, and the same reference numerals will be used to refer to elements, structures, features, etc. in common with the catheter of Figure 12B.

[0261] In contrast to catheter 700, in which the circulatory flow device 702 is disposed within the catheter body 191, catheter 800 includes a circulatory flow device 802 supported by the energy delivery member 155B. More specifically, the circulatory flow device 802 is contained within the passageway 156B of the energy delivery member 155B to direct blood flow within the delivery member 155B and replace the valve 151B of FIG. 12B described above. As discussed with respect to catheter 700, depending on the particular rotational orientation, the circulatory flow device 802 can direct blood flow in the energy delivery member 155B in a proximal direction (indicated by arrow 1) or a distal direction (indicated by arrow 2). Note that the circulatory flow device 802 can be located in the openings / passageways of other energy delivery members disclosed herein.

[0262] 24A-F, a method of performing a surgical procedure (e.g., a lithotripsy procedure) will be discussed in connection with a surgical system 900 including a delivery (outer) catheter 1000 and another embodiment of a (bypass) catheter of the present disclosure, identified by reference numeral 1100. The (inner) catheter 1100 is substantially similar to catheter 600 (FIGS. 20-21B) and, therefore, for the sake of brevity, will be discussed only with respect to any differences. Therefore, the same reference numerals will be utilized to refer to elements, structures, features, etc. common to catheters 600 and 1100. It should be noted that other catheters disclosed herein may be used to perform other procedures in addition to lithotripsy.

[0263] Delivery catheter 1000 is configured to receive and facilitate placement of catheter 1100 within access vessel A (see also FIG. 14D ) in a manner that allows access to target tissue, illustrated as a patient's heart valve C in the particular procedure shown. While delivery catheter 1000 and catheter 1100 are each illustrated as including a circular (or near-circular) cross-sectional configuration (e.g., diameter), alternative configurations are contemplated herein. For example, it is contemplated that delivery catheter 1000 and catheter 1100 may include corresponding non-circular cross-sectional configurations (e.g., square, rectangular, hexagonal, octagonal, pentagonal, "house" silhouette, oval, elliptical, star-shaped, etc.) to inhibit (if not completely prevent) relative rotation between delivery catheter 1000 and catheter 1100. In the context of a star-shaped cross-sectional configuration, any shape of star may be used, including, for example, a six-pointed star, a "Star of David," etc. It is also contemplated that delivery catheter 1000 and catheter 1100 may include different cross-sectional configurations in some embodiments.

[0264] In contrast to catheter 600 (FIGS. 20-21B), in which the energy delivery members 602a, 602b are supported externally to the catheter body 191, in the context of catheter 1100, the energy delivery members 602a, 602b are supported on (engaged with) a carrier 1102 (e.g., a rod, wire, etc.) that is configured for insertion into the catheter body 191 (e.g., via lumen 193) such that the catheter body 191 and the carrier 1102 are axially movable relative to one another (e.g., along longitudinal axis X3).

[0265] During a surgical procedure, the delivery catheter 1000 is positioned within the access vessel A ( FIG. 24A ) and advanced to the target tissue. As seen in FIG. 24B , in the particular procedure shown, the delivery catheter 1000 is advanced within the heart valve C to separate the valve leaflets Li, Lii. The catheter 1100 is advanced within the heart valve C to deploy the energy delivery member 602b by causing relative axial movement between the energy delivery member 602b and the catheter body 191. Deployment of the energy delivery member 602b can be achieved, for example, by advancing the carrier 1102 distally relative to the catheter body 191 (and delivery catheter 1000) and / or by retracting (pulling) the catheter body 191 (and delivery catheter 1000) relative to the carrier 1102. During deployment, as the energy delivery member 602b exits the catheter body 191, the energy delivery member 602b (automatically) reconfigures from the stored (first, compressed) configuration ( FIG. 24B ) to the expanded (second) configuration ( FIG. 24C ), which is facilitated by the flexible and resilient construction of the energy delivery member 602b described above. As seen in FIG. 24D , the delivery catheter 1000 and catheter body 191 are moved (retracted) proximally so as to be disposed proximal to the target tissue, and the carrier 1102 is moved proximally so as to bring the energy delivery member 602b into contact with (or proximal to) the heart valve C, as seen in FIG. 24E . It is envisioned that in some methods of use, the proximal movement of the carrier 1102 may be achieved in cooperation with the delivery catheter 1000 and catheter 1100.

[0266] Following placement of the energy delivery member 602b in the manner illustrated in Figure 24E, the energy delivery member 602a is deployed proximal to the heart valve C by inducing relative axial movement between the carrier 1102 and the catheter body 191 (and delivery catheter 1000) in a manner similar (if not identical) to that discussed above in connection with deployment of the energy delivery member 602b. During deployment, like the energy delivery member 602b, the energy delivery member 602a reconfigures (automatically) from a stored (first, compressed) configuration (Figures 24B-24D) to an expanded (second) configuration (Figure 24E) as the energy delivery member 602a exits the catheter body 191, again facilitated by the flexible and resilient construction of the energy delivery member 602a described above. As seen in FIG. 24F, the energy delivery member 602a is positioned between the energy delivery members 602a, 602b (e.g., within the space 616) so that the energy delivery member 602a is in contact with (or positioned proximal to) the heart valve C, and so that the heart valve C (e.g., the leaflets Li, Lii) are disposed between the energy delivery members 602a, 602b.

[0267] In the particular embodiment of the present disclosure illustrated in Figures 24A-F, the energy delivery member 602a is movably (e.g., slidably) supported on (or mated with) the carrier 1102, which allows relative axial movement between the energy delivery member 602a and the carrier 1102 (e.g., along the longitudinal axis X3). To facilitate such movement, it is envisioned that the catheter 1100 may include (or be used with) a pusher 1104 (Figures 24E, 24F) that is substantially similar (if not identical) to the pusher 618 (Figure 21A) described above. More specifically, a force is applied to the pusher 1104 to advance the energy delivery member 602a distally toward the heart valve C until the energy delivery member 602a is positioned as illustrated in Figure 24F. It is envisioned that the pusher 1104 may either be fixedly connected to the energy delivery member 602a, like pusher 618 (and 618a, 618b), or alternatively, may be selectively mateable with the pusher 1104 and energy delivery member 602a, as shown in Figures 24E and 24F, and may also allow for selective mating between the pusher 1104 and the energy delivery member 602b (e.g., to adjust the position of the energy delivery member 602b). The pushers 1104, 618, etc. may be configured to pull / move the energy delivery member proximally.

[0268] As discussed above in connection with catheter 600 (FIG. 21A), the pusher 1104 may be disposed external to the catheter body 191, may extend into (or be embedded in) the catheter body 191, may extend into the (main working) lumen 193, or the catheter body 191 may include another (separate) lumen configured to accommodate the pusher 1104.

[0269] Following placement of the target tissue between the energy delivery members 602a, 602b in the manner illustrated in FIG. 24F, energy is transmitted to the target tissue through the energy emitters 197i, 197ii included in the energy delivery members 602a, 602b, respectively (in the same manner as discussed above) to treat the target tissue (e.g., soften any calcification on the valve leaflets Li, Lii).

[0270] It is contemplated that any of the catheters / instruments described herein may optionally include one or more steerable segments (zones) that are deflectable via one or more pull wires (or alternatively, push wires) extending (embedded) within the wall of the catheter such that the catheter is reconfigurable (i.e., deflectable) between various configurations. Additionally (or alternatively), it is contemplated that any of the catheters (or other instruments) described herein may (optionally) include an integrated visualization instrument or system (e.g., a camera, etc.) that facilitates imaging during a surgical procedure.

[0271] The catheter may include or be connected to any suitable mechanism, including, for example, a wheel, ratchet, or the like, to vary the tension on the pullwire, thereby bending (flexing) the device, as described in more detail below. The term "steerability," as used herein, should be understood to refer to the ability to pivot, rotate, or otherwise flex the catheter / device. While the following discussion is provided in connection with catheter 190 of FIG. 14, it should be recognized that the following principles are equally applicable to any of the catheters (or other devices) described herein.

[0272] 25-27, a catheter 900 can include multiple segments 1200 and one or more pull wires 1202 to facilitate bending (flexing) and reconfiguration. For clarity, only the catheter body 191 is shown in FIGS. 25-27 (e.g., the energy delivery member 195, energy emitter 197, connector 197a, and energy source F are omitted from the figures). The catheter 900 includes multiple non-working (passive) segments 1200i and multiple working (steerable, bendable, or curved) segments 1200a connected to the multiple pull wires 1202. The non-working segments 1200i and working segments 1200a are arranged in an alternating pattern along a longitudinal axis X defined by the catheter body 191 such that the catheter 900 alternates between the non-working segments 1200i and working segments 1200a.

[0273] Each working segment 1200a is connected to a corresponding (single) pullwire 1202 that extends through (e.g., resides within) the outer wall of catheter 900 (e.g., such that the pullwire 1202 is embedded in catheter body 191), such that the number of pullwires 1202 corresponds to the number of working segments 1200a. Upon application of an axial (pulling) force to each of the pullwires 1202, the corresponding working segment 1200a flexes (bends) to reconfigure (actively steer) catheter 900 between a first (initial, normal) configuration ( FIG. 25 ), in which catheter 900 comprises a (nearly) linear configuration, and a second (subsequent, flexed) configuration ( FIG. 27 ), in which catheter 900 comprises a nonlinear configuration.

[0274] The use of a single pull wire 1202 associated with each working segment 1200a reduces the required number of pull wires 1202, thus reducing the complexity of both the construction and operation of the catheter 900. It is contemplated that other embodiments may include multiple independently movable pull wires 1202. In the particular embodiment shown, each pull wire 1202 is housed in a corresponding lumen 1204 (FIG. 26) that extends through the outer wall 901o of the catheter 900 in (substantially) parallel relationship to the longitudinal axis X (e.g., such that the pull wires 1202 are embedded within the catheter 900). In an alternative embodiment, the pull wires extend into a lumen within the primary central lumen.

[0275] To facilitate application of axial force to the pull wires 1202, in some embodiments, the catheter 900 may include (or be connected to) a corresponding plurality of actuation mechanisms 1206 (e.g., so that the number of pull wires 1202 corresponds to the number of actuation mechanisms 1206). In the particular embodiment shown, the catheter 900 includes a (first) actuation mechanism 1206i connected to the pull wires 1202i and a (second) actuation mechanism 1206ii connected to the pull wires 1202ii. The actuation mechanisms 1206 may include any structure or mechanism, such as a rotating wheel or pulley system, suitable for the intended purpose of applying the axial force to the pull wires 1202 necessary to deflect the catheter 900, if necessary or desired. In some embodiments, the actuation segment 1200a, pull wires 1202, and actuation mechanism 1206 may be configured (and connected) such that each pull wire 1202 can be individually actuated to deflect (steer) the corresponding segment 1200a in only a single direction. In other embodiments, pull wires 1202 may be provided around various circumferences of the catheter 900 to facilitate steering of the distal region of the catheter in various directions. For example, the wires may have a neutral position where distal movement causes the catheter to bend in a first direction and proximal movement causes the catheter to bend in a second direction. In an alternative embodiment, push wires are provided to induce bending / bending in place of pull wires.

[0276] In the illustrated embodiment, catheter 900 includes a first non-working segment 1200i1, a first working segment 1200a1 disposed distally of non-working segment 1200i1, a second non-working segment 1200i2 disposed distally of working segment 1200a1, and a second working segment 1200a2 disposed distally of non-working segment 1200i2. Additionally, catheter 900 includes first and second pullwires 1202i, 1202ii disposed within conduits 1204 (FIG. 26). However, it is also contemplated that first and second pullwires 1202i, 1202ii may be disposed in separate conduits 1204 (e.g., such that the number of conduits 1204 corresponds to the number of pullwires 1202).

[0277] Pull wires 1202i, 1202ii (in addition to actuation mechanisms 1206i, 1206ii) are connected to segments 1200a1, 1200a2, respectively, at connection points 1208i, 1208ii to facilitate reconfiguration of catheter 900 between the first configuration (FIG. 25) and the second configuration (FIG. 27). More specifically, upon reconfiguration / flexion of catheter 900, working segments 1200ai, 1200aii define respective first and second bends 1210i, 1210ii (FIG. 27), which may be substantially similar (e.g., identical) or dissimilar, depending, for example, on the particular configuration of segments 1200a1, 1200a2, the materials of construction used in catheter 900, the particular requirements of catheter 900 specified in the surgical procedure, etc. 27 illustrates bends 1210i, 1210ii as being (approximately) equal to 90 degrees, it is contemplated that bends 1210i, 1210ii may be substantially within a range of about 0 degrees to about 270 degrees, depending on the particular configuration of segments 1200a1, 1200a2, the requirements of the surgical procedure, the particular anatomy of the patient, etc. For example, in a particular embodiment, it is contemplated that segment 1200a1 may be configured such that bend 1210i is substantially within a range of about 0 degrees to about 180 degrees (e.g., about 90 degrees to about 180 degrees) and segment 1200a2 may be configured such that bend 1210ii is substantially within a range of about 0 degrees to about 270 degrees (e.g., about 90 degrees to about 270 degrees).

[0278] In the particular embodiment shown, connection points 1208i, 1208ii are shown as being in (generally) angular alignment (e.g., along the circumference of catheter 900), which promotes bending of segments 1200a1, 1200a2 in similar (e.g., the same) directions, as seen in Figure 27. However, it is also contemplated that connection points 1208i, 1208ii may be angularly offset to promote bending of segments 1200a1, 1200a2 in dissimilar directions. For example, connection points 1208i, 1208ii may be oriented in (generally) opposite directions, such that bends 1210i, 1210ii defined by segments 1200a1, 1200a2, respectively, curve in (generally) opposite directions.

[0279] It should be appreciated that the number of bending regions can vary, such as only one bending region, or two bending regions (as in FIG. 27), or more than two bending regions. The number of pull or push wires will vary to accommodate the number of bending regions.

[0280] Various mechanisms and features may be used to steer the catheters disclosed herein, as disclosed in PCT Application No. PCT / US22 / 51599, filed December 2, 2022, and U.S. Patent Application Publication No. 2021 / 0259860, the entire contents of both of which are incorporated herein by reference. Wires for applying a twisting force to rotate the catheter, as disclosed in Patent Application Publication No. 2021 / 0259860, may be utilized with any of the catheters disclosed herein.

[0281] As discussed above, the catheters disclosed herein may have a circular (or approximately circular) or non-circular cross-section (diameter) and / or a circular (or approximately circular) or approximately circular lumen.

[0282] The catheters of the present invention are preferably placed in a minimally invasive manner, most often percutaneously, e.g., via the femoral or radial artery, and advanced intravascularly (through the vascular system) to the target tissue site, e.g., adjacent to a blood clot. The catheter is configured for temporary placement and is removed after the procedure. Alternatively, the catheter can be left in place for a period of time.

[0283] Although generally discussed in the context of surgical procedures performed on anatomical valves (e.g., a patient's heart valves), it should be appreciated that the various embodiments of the catheters described herein may be configured for use during treatment of other areas and tissues.

[0284] Although described in connection with treating blood clots, the catheters disclosed herein may be used to crush or dissolve agents and / or deliver drugs to other areas of the body to perform other surgical procedures during which immediate reperfusion, continuous and / or controlled blood flow is desirable, and are ideally adapted for any luminal structure that may have an obstruction.

[0285] It will be understood that the particular embodiments above have been shown and described by way of example only. The principles and features of this invention can be employed in many different embodiments without departing from the scope and spirit of the claimed disclosure. The above-described embodiments do not limit the scope of the disclosure, and it should be understood by those skilled in the art that various modifications may be made (and equivalents may be substituted) without departing from the true spirit and scope of the invention. In addition, many modifications may be made within the objective spirit and scope of the invention to adapt to a particular situation, material, composition of matter, process, process step or steps. All such modifications are intended to be within the scope of the appended claims.

[0286] Those skilled in the art will appreciate that elements and features illustrated or described in connection with one embodiment may be combined with those of another embodiment without departing from the scope of the invention as presented.

[0287] When a range of values ​​is presented, it is understood that each intervening value between the upper and lower limits of the range is encompassed within the invention.

[0288] It must be noted that as used in this specification and the appended claims, the singular forms "a," "and," and "the" include plural references unless the context clearly indicates otherwise.

[0289] Throughout this disclosure, terms such as "approximately," "generally," and "substantially" should be understood to allow for variation of any numerical range or concept to which it is associated. For example, the use of terms such as "approximately" and "generally" should be understood to include variations on the order of 25% (e.g., allowing for manufacturing tolerances and / or design variations).

[0290] Although terms such as "first," "second," "third," etc. may be used herein to describe various operations, elements, components, regions, and / or sections, these operations, elements, components, regions, and / or sections should not be limited by the use of these terms in that these terms are used to distinguish one operation, element, component, region, or section from another. Thus, unless expressly stated otherwise, a first operation, element, component, region, or section may be referred to as a second operation, element, component, region, or section without departing from the scope of the present disclosure.

[0291] All claims are incorporated into the specification as further disclosure and represent embodiments of the present disclosure. Also, the phrases "at least one of A, B, and C" and "A and / or B and / or C" should each be interpreted to include A only, B only, C only, or any combination of A, B, and C.

[0292] Various combinations of all of the above described devices and methods may be utilized in the same procedure, sequentially, and / or simultaneously. [Explanation of symbols]

[0293] 1a, 1b, 1c, 1d Bypass catheter 2 side holes 3 valves 4 Distal hole 5 First Segment 6 Second Segment 7 Proximal end hole 8. Balloon 10 Inner diameter 11 Inner hole 12 Pressurized Fluid Bags 13 Tubing 14 Wall 15,15',15” lumen 17,17',17” central lumen 30 perforation 32 ends 36,36',36” pipe 37 Tubes 38 Control Device 39 Suction control device 39a Tubing 50 balloons 52 Pipeline 60 Outer support sheath 67 Proximal opening 70 Maceration Factors 72 Bypass Catheter 73 Motor 74 Maceration Factors 75 Rotating shaft 76 Distal foramen 77 Lumen 78 Side hole 80 Bypass Catheter 82 proximal end 83 Opening 84 distal end 85a,85b,85c pipeline 86 Distal foramen 87 Energy Emitter 88 Side hole 89 Wire 90 Bypass Catheter 91 Tubes 93 Perforation 95a,95b,95c pipeline 96 Distal foramen 97 Energy Emitter 98 Side hole 99 Wire 100 catheters 101 Filters 101a, 101b Wire 102 Side hole 104 Distal end hole 107 Proximal Opening 110 Catheter 111 Filters 111a, 111b wire 112 Side hole 114 Distal end hole 117 Proximal Opening 120 Catheter 122 Side hole 124 Energy Emitter 125 Balloon 126 Distal foramen 127 Wire 128 wires 128a area 130 Distal Filter 131 Filter Materials 132 areas 133 Wire 140 Catheter 142 Catheter body 143 Lumen 145 Distal Region 146 Proximal Region 147 Proximal Opening 149 Expansion member 150 ports 151A, 151B, 151C valves 151Ai,151Aii,151Aiii Apex 152 Connector 153 Pipeline 154 Distal opening 155, 155A, 155B, 155C Energy delivery members 156,156A,156B,156C aisle 157,157i,157ii,157iii Energy Emitter 158B External surface 158i,158ii end face 159 Main Unit 159a Exterior 160 Catheters 162 Side hole 163 Proximal foramen 164 wires 166 Energy delivery member 167 Distal Opening 168 filters 170 Catheter 171 Distal Region 172 Catheter body 173 Proximal Region 174 Distal Opening 175 Energy Delivery Member 175A Extension Member 176 Pipeline 177 Proximal Opening 178 Passage 179,179A Valve 179Ai, 179Aii Valve cusp 179i, 179ii, 179iii Valve cusp Port 180 181 Passage 182 1st (distal) part 183 Tubular members 184 Second (proximal) part 185 Valve 186 Middle part 187 Energy Emitter 187A First Branch 187B Second Branch 187i,187ii,187iii,187iv Legs 188 Gap 189 Connector 190 Catheter 191 Catheter body 191a distal region 191b proximal region 192 1st (distal) part 192A (distal) end face 193 Main Unit 193i 1st lumen 193ii Second lumen 194 Second (proximal) part 194A (proximal) end face 195 Energy Delivery Member 196 Middle part 197a Connector 197,197i,197ii,197iii,197iv Energy Emitter 198 Gap 199a side hole 199b Distal end hole 200 Bypass Catheter 202 catheter body 203 Lumen 205 Distal energy delivery member 206 Side hole 207 Proximal Energy Delivery Member 208 Space / Gap 209 Distal end hole 211 Energy Emitter 211A First (distal) bifurcation 211B Second (proximal) bifurcation 213 Connector 215 1st aisle 217 2nd aisle 219 Valve 300 Bypass Catheter 302 Energy Delivery Member 304 Exterior 306 Pipeline 400 catheters 402 Energy Delivery Member 404 Energy Delivery Member 406 Main Unit 408 Main Unit 410 Exterior 412 Exterior 414 Passage 416 Passage 418 Valve 420 Valve 422 Pipeline 500,500A Bypass Catheter 502, 502A Energy Delivery Member 504,504A Proximal end face 506,506A Distal end face 508,508A aisle 509A Valve 510,510A outer periphery 512 Brace 514ia,514ib Proximal strut 514iia,514iib Distal strut 600 Bypass Catheter 602 Energy Delivery Member 602a First (proximal) energy delivery member 602b second (distal) energy delivery member 612 Aperture 614 Valve 616 Containment Space 618,618a,618b Pusher 700 Bypass Catheter 702 Circulating flow device 704 Impeller 706 shaft / head 708 Vane 800 Bypass Catheter 802 Circulating flow device 900 Surgical Systems / Catheters 901o exterior wall 1000 Delivery (Outer) Catheter 1100 Bypass catheter 1102 Career 1104 Pusher 1200i1,1200i2 Non-active segments 1200a1, 1200a2 action segment 1202i, 1202ii pull wire 1204 Pipeline 1206i 1st activation mechanism 1206ii 2nd activation mechanism 1208i,1208ii connection point 1210i, 1210ii Bending section A. Ultrasound source / access vessel B. Drug Source C Pulse Generator / Heart Valve D, D0, D1, D2 cross-sectional dimensions E. External energy source F. External energy source Li,Lii leaflet M Auxiliary medical equipment X2, X3, X4 Longitudinal axis

Claims

1. a catheter body defining a longitudinal axis and including a first lumen extending therethrough; an energy delivery member supported by the catheter body such that the energy delivery member extends radially outward, The main body and a passageway extending through the body in a generally parallel relationship to the longitudinal axis; a valve disposed within the passageway to prevent blood flow through the energy delivery member; an energy emitter configured to deliver energy to a target tissue to facilitate treatment of the target tissue; an energy delivery member comprising: a connector extending from the energy emitter to an external energy source to provide energy to the energy emitter; A catheter for intracavitary lithotripsy, comprising:

2. The catheter of claim 1 , wherein the first lumen is configured to accommodate an ancillary medical device.

3. The catheter of claim 1 , wherein the energy delivery member is supported by the catheter body such that the passageway is disposed eccentrically relative to the longitudinal axis.

4. The catheter of claim 1 , wherein the energy delivery member is expandable.

5. the energy delivery member a proximal portion; a distal portion; and an intermediate portion disposed between the proximal portion and the distal portion; Including, the intermediate portion defines a second cross-sectional dimension that is smaller than the cross-sectional dimensions of the proximal and distal portions, such that, upon expansion of the energy delivery member, the proximal and distal portions each define a cross-sectional dimension such that the energy delivery portion includes a waist that defines a gap configured to accommodate the target tissue. The catheter of claim 4.

6. The catheter of claim 4 , wherein the energy delivery member comprises a generally toroidal configuration.

7. 2. The catheter of claim 1, wherein the energy delivery member is generally cylindrical and defines proximal and distal end faces each having a generally planar configuration, and the energy emitter is supported adjacent at least one of the proximal and distal end faces.

8. The catheter of claim 1 , wherein the energy delivery member comprises a deformable material to allow reconfiguration of the energy delivery member during insertion and removal of the catheter.

9. The catheter of claim 1 , further comprising a second energy delivery member, the second energy delivery member configured as a separate structure axially spaced from the energy delivery member along the longitudinal axis.

10. The catheter of claim 9 , wherein at least one of the energy delivery member and the second energy delivery member is movable along the catheter body.

11. The catheter of claim 1 , wherein the catheter is steerable.

12. The catheter of claim 1 , wherein the valve opens intermittently.

13. The catheter of claim 1 , wherein the valve is configured to treat a heart valve.

14. The catheter of claim 1 , wherein a pressure gradient across the valve causes the valve to open.

15. The catheter of claim 14 , wherein blood flows through the valve when the valve is open.

16. a catheter body defining a longitudinal axis; An impeller that guides blood flow, an energy delivery member extending radially outward from the catheter body, a body having a generally annular cross-sectional configuration; an energy emitter configured to deliver energy to a target tissue to facilitate treatment of the target tissue; an energy delivery member comprising: a connector extending from the energy emitter to an external energy source to provide energy to the energy emitter; A catheter for intracavitary lithotripsy comprising:

17. The catheter of claim 16, wherein the impeller is disposed within a lumen of the catheter body.

18. The catheter of claim 16, wherein the energy delivery member includes a passageway and the impeller is disposed within the passageway.

19. The catheter of claim 16, wherein the catheter body defines a first lumen configured to house the impeller and a second lumen.

20. 20. The catheter of claim 19, wherein the second lumen is configured to accommodate the auxiliary medical device.

21. the energy delivery member is expandable; a proximal portion; a distal portion; and an intermediate portion disposed between the proximal portion and the distal portion; Including, when the energy delivery member is expanded, the proximal portion and the distal portion each define a first cross-sectional dimension, and the intermediate portion defines a second cross-sectional dimension smaller than the first cross-sectional dimension such that the energy delivery member includes a waist defining a gap configured to accommodate the target tissue.

17. The catheter of claim 16.

22. 22. The catheter of claim 21, wherein the energy emitter includes at least two spaced apart energy emitting surfaces.

23. 23. The catheter of claim 22, wherein the energy emission surfaces are configured to compress opposing sides of tissue and are located on different sides of the waist.

24. 24. The catheter of claim 23, wherein the energy delivery member is configured to treat a heart valve.

25. a) a catheter, A catheter body; an energy delivery member extending radially from the catheter body, the energy delivery member including a passageway extending therethrough; inserting a catheter including: b) intermittently blocking blood flow at the energy delivery member using a valve supported within the passageway; c) positioning the energy delivery member in proximity to a target tissue; d) applying energy to the energy delivery member to treat the target tissue; 10. A method of performing an intracavitary fragmentation procedure, comprising:

26. 26. The method of claim 25, wherein positioning the energy delivery member adjacent to the target tissue comprises expanding the energy delivery member such that the target tissue is received in a gap defined between proximal and distal portions of the energy delivery member.

27. 27. The method of claim 26, wherein positioning the energy delivery member proximate to the target tissue comprises positioning a first energy delivery member distal to the target tissue and positioning a second energy delivery member proximal to the target tissue.

28. 26. The method of claim 25, further comprising inducing blood flow in the catheter by rotating an impeller disposed within the catheter body.

29. 28. The method of claim 27, wherein the target tissue is a valve.

30. 30. The method of claim 29, wherein the valve is a heart valve.

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