Catheter for endovascular lithotripsy with energy delivery member and valve

Abstract

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

Description

Background Art

[0001] This application is a continuation-in-part of application serial number 16 / 875,122, filed May 15, 2020, which is a continuation-in-part of application serial number 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. 1. Technical Field

[0002] The present invention relates generally to minimally invasively inserted catheters and, more particularly, to a catheter having an expandable structure with an energy emitter and a valve for intravascular lithotripsy.

[0003] 2. Background of Related Technology

[0004] The prior art teaches the use of devices in conjunction with medical procedures to control blood flow in blood vessels. The most common of these is a balloon catheter. Balloon catheters, such as those taught in the prior art, can be used to isolate a body part from its blood supply when the balloon is inflated (expanded), occupying space in the blood vessel and blocking blood flow.

[0005] One of the problems associated with the use of balloons is that, although control of blood flow through a portion of a blood vessel (including blocking the blood supply to the target site) is achieved, blood flow to other sites near the target site is completely interrupted. This disadvantage is tolerable for a short period of time because when a blood vessel is blocked, the body typically increases blood flow through other substantially parallel blood vessels. However, this interruption of blood flow is problematic when used for longer durations. Complex medical procedures may not be completed during the shorter duration, resulting in damage to other sites or the need for multiple operations at the same target site. A device is needed for better blood flow control during surgical procedures.

[0006] Additionally, current bypass catheters are designed to be surgically implanted, which is not practical for immediately relieving ongoing ischemia caused by a sudden blockage of a blood vessel, such as by a thrombus or embolus.

[0007] Various devices are known for performing thrombectomy (i.e., removing a blood clot from a blood vessel). These devices include, for example, mechanical thrombectomy devices with rotating elements to break up the clot, devices that deliver thrombolytic agents to dissolve the clot, and devices that deliver vibrational energy in the form of continuous or pulsed waves. However, these devices do not provide adequate control of blood flow during the procedure. Furthermore, these procedures can often be lengthy and most often fail to provide immediate restoration of blood flow to the ischemic area.

[0008] It would be advantageous to provide control of blood flow during the removal or treatment of blood clots or other obstructions or the removal or softening of calcifications. This is particularly advantageous in relatively long surgeries (such as the use of thrombolytics) where the clots are dissolved over time by the thrombolytic infusion, as it would provide immediate and continuous reperfusion. A further advantage would be the ability to provide immediate restoration of downstream blood flow, thereby allowing time for the obstruction to improve while preventing further progression of ischemic damage to the affected vascular territory. This is not possible with any current device. Summary of the Invention

[0009] The present invention overcomes the problems and shortcomings of the prior art. It provides an improved catheter and method for use within the body's vascular system, addressing the problem of complete blood flow interruption leading to ischemia, which, if not quickly reversed, can result in permanent damage. Specifically, the present invention is used to treat clots or other obstructions in arteries or veins that result in ischemia or cardiac stress due to lack of blood flow.

[0010] Additionally, the present invention, in some embodiments, provides an improved catheter and method for intraluminal lithotripsy and, in certain applications, for softening the calcium of highly calcified valves, such as heart valves.

[0011] The present invention, in some aspects, provides a bypass catheter that is temporarily placed in the body, i.e., during a surgical procedure or for a fixed period of time, and has a distal opening (orifice) and a more proximal intravascular opening (orifice) to allow blood to flow from the proximal region of the clot to the distal region of the clot during the clot treatment procedure. Various embodiments of the bypass catheter are disclosed herein, including different devices for treating / removing blood clots. In some embodiments, the catheter also includes a structure that limits retrograde blood flow through the catheter to enhance the reperfusion function of the catheter. In some embodiments, the catheter includes a filter at the distal portion to capture or block particles.

[0012] In some embodiments, the present invention includes temporary bypass balloon-mounted catheters, single lumen difficult-access support catheters, and rotary irrigation and aspiration thrombectomy devices. These are disclosed in application serial number 15 / 732,397 (temporary bypass balloon catheter); and application serial numbers 15 / 258,877, 15 / 538,898, and 15 / 731,478 (rotating separators, irrigation microcatheters for thrombectomy); and other Walzman single lumen support disclosures, and the present invention provides improvements thereto in these embodiments.

[0013] The device 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 located on one side of the arterial or venous clot / obstruction and a more distal hole (e.g., distal end hole) of the device is located on the other side of the arterial or venous clot / obstruction. Once the device is positioned in a desired area in a blood vessel, the bypass element of the device allows for temporary bypass of blood flow through a catheter (e.g., through a first or distal segment of a catheter as described below).

[0014] In some embodiments, to prevent blood from flowing back into the catheter, i.e., into the section (region) proximal to the side hole of the catheter, a structure is provided to limit backflow. Various embodiments of such a structure are disclosed herein, and these embodiments include a valve for providing blood flow in one direction (distal direction), a smaller (reduced) proximal diameter, or attachment to a pressurized fluid line, or a combination thereof. These are discussed in more detail below.

[0015] Furthermore, in some embodiments, the catheter of the present invention may have, in addition to or in lieu of a lumen that may extend substantially within the wall of the catheter for delivering fluid to the balloon to inflate it, an additional lumen that extends substantially within the wall of the intravascular segment of the catheter, which lumen delivers fluid to the clot between the side hole and the end hole via at least one perforation that communicates with the interior of the blood vessel. This allows for the delivery of a dissolving agent or other such drug to the clot while effectively temporarily bypassing blood flow through the catheter, thereby allowing time for the directly applied drug to disrupt and dissolve the clot while avoiding progressive ischemic tissue damage during the interim period.

[0016] In some embodiments, the catheter has a balloon (or other anchoring structure) disposed on its outer diameter (outer wall), and the catheter may include an additional lumen within or substantially within the wall of the intravascular section of the catheter for inflating and deflating the balloon.

[0017] Additionally, in some embodiments, a mechanical thrombectomy structure may be provided to break up the clot, such as a side ring as described below, which macerates the clot when rotated.

[0018] In some embodiments, suction can also be applied to the catheter, which can allow suction to be applied through the side holes and / or through the end holes. If suction is only required through the end holes, the side holes can be pulled into the sheath or otherwise covered as described below so that the side holes are blocked and no suction occurs on the side holes, with all suction force being on the end holes. Alternatively, an actively controlled valve can be provided to close the side holes.

[0019] A key advantage of the devices of the present invention is that they allow for the rapid restoration of temporary blood flow through the obstruction to avoid ischemic injury, wherein a degree of blood flow outside the clot is immediately restored. This will allow additional time to remove or dissolve the clot while allowing flow to the tissue at risk. Additionally, in the case of a large pulmonary embolism, the lack of outflow from the right side of the heart can also cause additional problems in terms of cardiac burden. The temporary bypass catheters described herein can also help alleviate this cardiac burden when a large pulmonary embolism is present in the main pulmonary artery by allowing outflow from the right side of the heart to pass through the clot.

[0020] According to one aspect of the present invention, a surgical device for treating a blood clot or other obstruction in a patient's blood vessel is provided, the device comprising an elongated member, preferably tubular, having an outer wall, a first opening (aperture) at a distal portion, and a second opening (aperture) spaced proximally from the distal aperture. The second aperture is preferably positioned in one side of the outer wall. A first lumen is disposed within the elongated member for allowing blood to flow through the proximal second aperture, through the first lumen, and out the distal first end aperture to maintain blood flow during treatment of the blood clot. In some embodiments, the first lumen is a single main central lumen.

[0021] In some embodiments, at least one perforation may be positioned between the first and second holes. A second lumen within the wall of the intravascular segment (substantially within the wall or within the main lumen) communicates with the at least one perforation. The second lumen forms a passageway for injecting a fluid into the blood vessel through the at least one perforation to treat a blood clot, wherein during the injection of the fluid to treat the blood clot, blood flows into the second hole positioned proximal to the blood clot and out of the first hole distal to the blood clot.

[0022] In some embodiments, there is at least one additional third proximal port having an attached external terminal device that remains external to the patient's body. When needed, suction can optionally be applied to the third proximal port to remove clots and debris from the blood vessel.

[0023] In some embodiments, the elongated member has at least one energy emitting element positioned thereon, and in some embodiments, these energy emitting elements are within or substantially within the wall of the elongated member to emit energy to assist in breaking down and removing blood clots. In some embodiments, the energy emitting element is positioned between the first hole and the second hole of the catheter. In some embodiments, the energy emitting element includes an ultrasonic radiating element to enhance the flow or mixing of fluid (medicine) injected from the catheter into the blood clot or injected adjacent to the blood clot. In some embodiments, the ultrasonic emission of the radiating element is synchronized with the time of fluid delivery. In some embodiments, the energy can directly break up larger clots. In some embodiments, the energy can help break down, soften and dissolve calcifications and other hardened materials. In some embodiments, a cooling element may be present. In some embodiments, a heating element may be present.

[0024] In some embodiments, at least one connector is provided to connect the energy emitter to an energy source to apply energy to a blood clot or other obstruction to assist in treatment, such as removing / dissolving a blood clot. In some embodiments, at least one connector is configured to connect the device to an ultrasonic energy source. In some embodiments, the energy emitting element extends within 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 can be incorporated into at least one balloon extending from the catheter. Such embodiments are particularly useful during intravascular lithotripsy of heart valves or intracranial vessels, where prolonged balloon inflation for optimal contact and treatment time may not be tolerated without a bypass element to allow blood to flow away from the heart and perfuse the cerebral vascular region, respectively.

[0025] The aforementioned energy sources and energy emitters can also be used with the inflatable spherical ball balloon disclosed in U.S. Patent No. 10,328,246, the entire contents of which are incorporated herein by reference. Such a device can be used during valvular lithotripsy while allowing blood to flow out of the heart through the central hole of the spherical ball balloon during prolonged balloon inflation for prolonged contact with the valve, or similarly, continuous blood flow through a blood vessel during intravascular use.

[0026] In some embodiments, the device includes a rotatable comminuting element positioned between the first aperture and the second aperture, the comminuting element being rotatable to break up blood clots and other intravascular debris and obstructions.

[0027] In some embodiments, the device includes a sheath positioned over the elongated member, the elongated member and the sheath being relatively movable to selectively cover and expose the side holes, wherein covering the side holes restricts the flow of blood through the side holes. In some embodiments, covering the side holes completely blocks the flow of fluid through the side holes. Covering the side holes can also be used to reverse blood flow, causing it to flow proximally through the catheter lumen. Suction can be provided in the lumen to assist or achieve this reverse flow.

[0028] In some embodiments, the device has features that limit retrograde blood flow within the catheter, such as a valve or a region of reduced diameter of the first lumen. In some embodiments, attaching a pressurized fluid to the catheter at the proximal region can limit retrograde blood flow within the catheter.

[0029] It is noted that in some embodiments, where there is an additional lumen passing through the intravascular segment of the elongated body, the device (preferably outside the patient's body) proximally divides into multiple lumens with independent outer walls. Preferably, each lumen terminates at its proximal end hole in an independent external terminal device, such as a port with a Luer lock or a septum.

[0030] According to another aspect of the present invention, a surgical device (apparatus) for treating a blood clot or other obstruction in a patient's blood vessel is provided, the device comprising an elongated member having an outer wall, a first opening (aperture) at a distal portion, and a second opening spaced proximally from the distal aperture. The second aperture is preferably positioned in one side of the outer wall. A first lumen is provided within the elongated member for allowing blood to flow through the proximal aperture, through the lumen, and out of the distal first aperture to maintain blood flow during treatment of the blood clot. The device comprises at least one energy emitter for emitting energy toward the blood clot and a connector extending through the elongated member to connect the energy emitter to an external energy source, wherein once the bypass segment is positioned across the obstruction, blood flows into the second aperture positioned proximal to the blood clot and out of the first aperture distal to the blood clot. Activation of the energy emitter may also be utilized at this location. Infusion of medication may also be utilized at this location.

[0031] In some embodiments, the energy transmitter is positioned between the first aperture and the second aperture. In some embodiments, the energy transmitter transmits ultrasonic energy toward the blood clot. In some embodiments, a switch is provided on the device for activating the energy transmitter. In some embodiments, a switch external to the device can activate the energy transmitter.

[0032] In some embodiments, the device further comprises a second lumen for delivering a drug to the clot to dissolve the clot. In some embodiments, this occurs during application of energy (eg, ultrasonic energy).

[0033] According to another aspect of the present invention, a method for treating a blood clot or other obstruction in a patient's blood vessel is provided, the method comprising the following steps: a) inserting a device (equipment) into the blood vessel, the device (equipment) having a first opening (hole) at a distal portion and a second opening (hole) spaced proximally from the distal hole, the second hole being positioned in one side of the outer wall; b) positioning the second hole of the device proximal to the blood clot and positioning the first hole of the device distal to the blood clot, thereby enabling blood to flow through the proximal hole, through the first lumen, and out of the distal hole to maintain blood flow during treatment of the blood clot; and c) applying energy to an energy emitter carried by the device to apply energy to the blood clot while the blood flows through the lumen.

[0034] In some embodiments, the method further comprises the step of injecting a thrombolytic fluid through one or more perforations in the sidewall of the device.

[0035] In some embodiments, the method further comprises the steps of selectively blocking blood flow through the second aperture and aspirating the clot through the first aperture via external suction applied to the third aperture (ie, the proximal end aperture located outside the patient's body).

[0036] In some embodiments, the method further comprises the step of injecting a thrombolytic fluid through one or more perforations in the sidewall of the device.

[0037] In some embodiments, the method further comprises the step of selectively blocking blood flow through the second aperture during subsequent aspiration.

[0038] In some embodiments, the device has at least one balloon on an outer surface of the elongated member positioned above the first lumen. In some embodiments, the device further comprises at least one energy emitter on or carried / supported by the balloon for emitting energy.

[0039] In some embodiments, the method further comprises the steps of: using a device as described herein and advancing the device across the valve; inflating a balloon while blood flows through the first lumen in any desired direction during inflation of the balloon; activating energy to break down and soften hardening in and around the valve; and deactivating the energy and deflation of the balloon.

[0040] In some embodiments, the hardened material is a calcified material.

[0041] In some embodiments, the inflation, energy emission, and deflation are repeated at least twice.

[0042] In some embodiments, the method includes a step of rotary comminution prior to aspiration.

[0043] According to another aspect of the present invention, a catheter for treating obstruction is provided, the catheter having a balloon carrying (supporting) or mounting one or more energy emitters. The balloon has a blood flow channel. More specifically, the catheter may have a round spherical balloon for energy delivery, and may have a single lumen therein, which allows the passage of filaments, fluid injections and / or fluids for inflating the balloon. In other embodiments, the round spherical balloon for energy delivery mounted on the catheter may have a single catheter lumen dedicated to the balloon. In other embodiments, the round spherical balloon for energy delivery mounted on the catheter may have multiple catheter lumens. It may be a single balloon or multiple balloons. The balloon may be on any section of the catheter. In some embodiments, the energy emitting element may extend onto the outer surface of at least one balloon.

[0044] According to another aspect of the present invention, a catheter for intraluminal lithotripsy is provided, the catheter having an outer wall, at least one round ball balloon mounted on the outer wall, a first lumen extending therein, at least one energy transmitter mounted on the balloon for transmitting energy to decompose calcium, and a connector for connecting the energy transmitter to an external energy source, the connector extending through the catheter.

[0045] In some embodiments, the catheter is capable of inflating at least one spherical ball balloon within a heart valve for extended periods of time without significantly obstructing outward cardiac flow. In some embodiments, the catheter is capable of inflating at least one spherical ball balloon within a blood vessel for extended periods of time without significantly obstructing blood flow. Thus, the opening in the spherical ball balloon allows blood flow during inflation, whereas without such an opening, the balloon would otherwise cut off blood flow when the inflated balloon fills the lumen of a blood vessel. In preferred embodiments, the balloon is inflated such that the energy emitter can contact target tissue (e.g., calcification within the lumen of a blood vessel).

[0046] In some embodiments, the catheter includes a second lumen, wherein the first lumen is dedicated to inflation and deflation of the toroidal ball balloon.

[0047] In some embodiments, the catheter comprises an energy emitter. In other embodiments, the catheter comprises a plurality of energy emitters spaced apart on a circular spherical balloon. In some embodiments, at least one energy emitter comprises a plurality of ultrasound radiating elements.

[0048] In some embodiments, the round ball balloon has an opening for providing a passageway for blood to pass therethrough. In some embodiments, the round ball balloon can be mounted eccentrically (e.g., offset from the longitudinal axis of the catheter) such that a portion or a majority of the balloon is offset to one side of the longitudinal axis and the passageway in the balloon is parallel to the longitudinal axis of the catheter. In some embodiments, the round ball balloon has a passageway therein for receiving the catheter, the passageway being radially spaced from the passageway.

[0049] In some embodiments, the toroidal spherical balloon has a circumferentially extending outer surface, and the channel of the toroidal spherical balloon is parallel to the longitudinal axis of the catheter, and the at least one energy emitter includes a plurality of energy emitters on the circumference of the toroidal spherical balloon for applying energy radially from the circumference of the balloon.

[0050] In some embodiments, the catheter includes a filter positioned distal to the spherical ball balloon to capture particles. The filter may also be optionally provided on other catheters disclosed herein.

[0051] According to another aspect of the present invention, a method of valve lithotripsy is provided, comprising the steps of introducing the aforementioned round ball balloon across the valve, inflating the round ball balloon, emitting energy for a period of time, then ceasing to emit energy, deflation of the balloon, and removing the catheter.

[0052] In some embodiments, inflating, emitting energy, and deflating are repeated at least twice before removing the catheter.

[0053] According to another aspect of the present invention, a catheter for intraluminal lithotripsy is provided, 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 has a smaller transverse dimension than the first and second portions. The catheter comprises a first lumen, at least one energy transmitter carrying / supporting or mounted on the balloon for transmitting energy to decompose or soften calcium, and a connector extending through the catheter for connecting the at least one energy transmitter to an external energy source.

[0054] In a preferred embodiment, the balloon is a round spherical balloon.In some embodiments, the balloon has a figure eight structure.

[0055] In some embodiments, the catheter is capable of being inflated within a heart valve for extended periods of time without significantly obstructing outflow from the heart.

[0056] In some embodiments, the at least one energy emitter includes an energy emitter on the second portion of the circular ball balloon facing the first portion, and at least one energy emitter on the first portion of the circular ball balloon facing the second portion. In some embodiments, the first portion and the second portion are configured to press against opposite sides of the heart valve. In some embodiments, the middle portion of the balloon forms a waist, thereby forming a gap between the first portion and the second portion of the circular ball balloon. The waist can be configured for positioning within the orifice of the heart valve, and the first portion and the second portion of the circular ball balloon press against opposite sides of the heart valve, for example, against the sides of the leaflets.

[0057] In some embodiments, the balloon has an opening for providing a passageway for blood to pass therethrough. In some embodiments, the balloon is mounted eccentrically (e.g., offset from the longitudinal axis of the catheter) such 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 channel for receiving the catheter, the channel being radially spaced from the opening in the balloon.

[0058] In some embodiments, the catheter has a filter member positioned distal to the balloon to capture particles.

[0059] In some embodiments, the catheter has an outer wall, a lumen, a first hole positioned at a distal portion distal to the balloon, and a second hole spaced proximally from the first hole and positioned proximal to the balloon and positioned in a side of the outer wall, wherein blood flows through the second hole, through the first lumen, and out of the first hole while the balloon is inflated and energy is emitted by at least one energy emitter.

[0060] In some embodiments, the axially slidable member is slidable relative to the catheter, and the catheter and the slidable member are relatively movable to selectively cover and expose the second hole, wherein covering the second hole restricts blood flow through the second hole. In some embodiments, the axially slidable member is external to the catheter; in other embodiments, it is internal to the catheter.

[0061] In some embodiments, the catheter includes a valve for limiting retrograde blood flow through the elongate member.

[0062] In some embodiments, the energy transmitter applies ultrasonic energy.

[0063] According to another aspect of the present invention, there is provided a method for reducing calcium at a heart valve of a patient, the method comprising:

[0064] a) inserting a device having at least one balloon extending from an outer wall into a blood vessel, the balloon having a first portion, a second portion proximate the first portion, and an intermediate portion between the first portion and the second portion, the intermediate portion having a transverse dimension that is smaller than the transverse dimensions of the first and second portions of the balloon, at least one energy transmitter on the first portion of the balloon, and at least one energy transmitter on the second portion of the balloon;

[0065] b) positioning the balloon adjacent a heart valve such that the first portion faces a first side of the valve and the second portion faces a second, opposite side of the valve, and the intermediate portion is positioned in the valve orifice; and

[0066] c) applying energy to at least one energy emitter to apply energy to the first side and the second side of the heart valve to break up or soften the calcium.

[0067] In some embodiments, the balloon is a spherical balloon and is mounted eccentrically (e.g., offset from the longitudinal axis of the catheter) and has an opening for blood to pass therethrough to pass through a heart valve that is also positioned eccentrically (e.g., such that the opening is offset from the longitudinal axis of the catheter).

[0068] In some embodiments, the balloon is a round ball balloon and the catheter has an outer wall, a lumen, a first hole positioned at a distal portion distal to the round ball balloon, and a second hole spaced proximally from the first hole and positioned proximal to the round ball balloon and positioned in a side of the outer wall, wherein blood flows through the second hole, through the first lumen, and out of the first hole while the balloon is inflated to bypass the heart valve. In some embodiments, the balloon is a round ball balloon and the round ball balloon is inflated to fill the lumen of a blood vessel, with the first portion pressed against a first side of the heart valve and the second portion pressed against a second side of the heart valve, and when the energy emitter applies energy to the first and second sides of the heart valve, blood bypasses the inflated balloon.

[0069] 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 by the catheter body so that the energy delivery member extends radially outward from the catheter body, 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 passage extending through the body in a substantially parallel relationship to the longitudinal axis, a valve positioned within the passage to inhibit blood flow through the energy delivery member, and an energy transmitter configured to transfer energy to the target tissue to facilitate treatment thereof. In some embodiments, the energy transmitter is supported near an outer surface of the body. A connector extends from the energy transmitter to an external energy source to supply energy to the energy transmitter.

[0070] In some embodiments, the first lumen is configured to receive an ancillary medical device.

[0071] In some embodiments, the energy delivery member may be supported by the catheter body such that the passageway is positioned eccentrically relative to the longitudinal axis.

[0072] In some embodiments, the energy delivery member can be expandable (eg, inflatable).

[0073] In some embodiments, the energy delivery member can include a proximal portion, a distal portion, and an intermediate portion positioned between the proximal portion and the distal portion. In some embodiments, when the energy delivery member is expanded, the proximal portion and the distal portion can each define a first transverse cross-sectional dimension, and the intermediate portion can define a second transverse cross-sectional dimension that is smaller than the first transverse cross-sectional dimension, such that the energy delivery member includes a waist defining a gap configured to receive target tissue.

[0074] In some embodiments, the energy delivery member may comprise a generally annular (ring) configuration.

[0075] In some embodiments, the energy delivery member may be generally cylindrical.

[0076] 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 may each have a substantially planar configuration. In some embodiments, the energy emitter may be supported adjacent to at least one of the proximal end face and the distal end face of the energy delivery member.

[0077] In some embodiments, the energy delivery member may comprise a deformable material to allow for reconfiguration of the energy delivery member during insertion and removal of the catheter.

[0078] In some embodiments, the energy delivery member may include a first energy delivery member and a second energy delivery member.

[0079] In some embodiments, the first and second energy delivery members can be configured as discrete structures that are axially spaced apart from each other along the longitudinal axis.

[0080] In some embodiments, at least one of the first energy delivery member and the second energy delivery member is movable along the catheter body.

[0081] In some embodiments, the catheter is steerable.

[0082] In some embodiments, the valve opens intermittently. In some embodiments, a pressure gradient across the valve causes the valve to open. In some embodiments, when the valve opens, blood flows through the valve.

[0083] In some embodiments, the valve is configured as a therapeutic heart valve.

[0084] In another aspect of the present disclosure, a catheter for intraluminal lithotripsy is disclosed. The catheter includes a catheter body, an impeller rotatably positioned within the catheter body to direct blood flow therethrough, an energy delivery member extending radially outward from the catheter body, and a connector. The energy delivery member includes a body having a generally annular transverse cross-sectional configuration, which, in some embodiments, can be supported adjacent an outer surface of the body. An energy emitter is configured to deliver energy to target tissue to facilitate treatment thereof, and a connector extends from the energy emitter to an external energy source to supply energy to the energy emitter.

[0085] The catheter body defines a longitudinal axis and, in some embodiments, is configured to receive an ancillary medical device therethrough or alternatively thereover.

[0086] In some embodiments, the impeller can be configured to selectively direct blood flow through the catheter body in a first (eg, distal) direction and in a second (eg, proximal) direction opposite (or substantially opposite) to the first direction.

[0087] In some embodiments, the impeller is positioned within the lumen of the catheter. In some embodiments, the impeller is positioned in the passageway of the energy delivery member.

[0088] In some embodiments, the catheter body may define a first lumen configured to receive the impeller and a second lumen configured to receive an auxiliary medical device.

[0089] In some embodiments, the catheter body and impeller may be configured such that after the ancillary medical device is inserted into the catheter body, the impeller rotates around the ancillary medical device.

[0090] In some embodiments, the energy delivery member can be expandable (eg, inflatable).

[0091] In some embodiments, the energy delivery member can include a proximal portion, a distal portion, and an intermediate portion positioned between the proximal portion and the distal portion. In some embodiments, when the energy delivery member is expanded, the proximal portion and the distal portion can each define a first transverse cross-sectional dimension, and the intermediate portion can define a second transverse cross-sectional dimension that is smaller than the first transverse cross-sectional dimension, such that the energy delivery member includes a waist defining a gap configured to receive target tissue.

[0092] In another aspect of the present disclosure, a method for performing an intraluminal lithotripsy procedure is disclosed, the method comprising: inserting a catheter having a catheter body and an energy delivery member supported by the catheter body such that the energy delivery member extends radially outward therefrom, wherein the energy delivery member includes a passage extending therethrough; intermittently inhibiting blood flow through the energy delivery member using a valve supported within the passage; positioning the energy delivery member near target tissue; and applying energy to the energy delivery member to treat the target tissue.

[0093] In some embodiments, applying energy to the energy delivery member may include transferring energy from an external energy source to an energy emitter supported adjacent to or on an external surface of the energy delivery member.

[0094] In some embodiments, positioning the energy delivery member proximate the target tissue may include expanding the energy delivery member such that the target tissue is received within a gap defined between the proximal and distal portions of the energy delivery member.

[0095] In some embodiments, positioning the energy delivery member proximate the target tissue may include positioning a first energy delivery member distal to the target tissue and positioning a second energy delivery member proximal to the target tissue. In some embodiments, the target tissue is a valve, such as a heart valve.

[0096] In some embodiments, the method may further include directing blood flow through the catheter by rotating an impeller positioned within the catheter body. BRIEF DESCRIPTION OF THE DRAWINGS

[0097] The present invention will be better understood and objects other than those mentioned above will become apparent when the following detailed description of the present invention is considered. This description refers to the accompanying drawings, in which:

[0098] Figure 1 is a side view of one embodiment of a bypass catheter of the present invention.

[0099] Figure 1A yes Figure 1 Transverse cross-section of the catheter.

[0100] Figure 1B yes Figure 1 Transverse cross-sectional view of an alternative embodiment of a catheter.

[0101] Figure 1C yes Figure 1 Transverse cross-sectional view of another alternative embodiment of a catheter.

[0102] Figure 2 is a side view of an alternative embodiment of a bypass catheter showing the inner diameter of the proximal section in phantom.

[0103] Figure 3 is a side view of an alternative embodiment of a bypass catheter of the present invention, the catheter being shown connected to a column of pressurized fluid via a third port at the proximal end of the catheter.

[0104] Figure 4 is a side view of an alternative embodiment of a bypass catheter of the present invention having perforations for infusing medication from the catheter into a blood vessel.

[0105] Figure 4A yes Figure 4 Transverse cross-section of the catheter.

[0106] Figure 4B yes Figure 4 Transverse cross-sectional view of an alternative embodiment of a catheter.

[0107] Figure 4C yes Figure 4 Transverse cross-sectional view of another alternative embodiment of a catheter.

[0108] Figure 5 is a side view of an alternative embodiment of a bypass catheter of the present invention.

[0109] Figure 6 is a side view of an alternative embodiment of a bypass catheter of the present invention having an ultrasonic energy emitter.

[0110] Figure 6A yes Figure 6 Transverse cross-section of the catheter.

[0111] Figure 7 is a side view of an alternative embodiment of a bypass catheter of the present invention having multiple electrodes.

[0112] Figure 7A yes Figure 7 Transverse cross-section of the catheter.

[0113] Figure 8 is a side view of an alternative embodiment of a bypass catheter of the present invention having a rotational mechanical thrombectomy device.

[0114] Figure 9 is a side view of an alternative embodiment of a bypass catheter of the present invention having a filter attached to the distal section.

[0115] Figure 10 is a side view of an alternative embodiment of a bypass catheter of the present invention having a filter attached to the distal end.

[0116] Figure 11 is a side view of an alternative embodiment of a bypass catheter of the present invention having a filter and an expandable member (e.g., a balloon) having a plurality of electrodes attached thereto, the expandable member being shown in an inflated state.

[0117] Figure 12 is a side view of an alternative embodiment of a catheter of the present invention having an energy delivery member supporting (connected to) a plurality of energy emitters (eg, electrodes).

[0118] Figure 12A yes Figure 12 Side view of an alternative embodiment of a bypass catheter in which the energy delivery member includes a valve.

[0119] Figure 12B yes Figure 12A Side view of an alternative embodiment of a bypass catheter in which the energy delivery member includes a different annular (ring) configuration.

[0120] Figure 12C yes Figure 12B Side view of an alternative embodiment of a bypass catheter.

[0121] Figure 13 is a side view of an alternative embodiment of a catheter for retrograde flow of the present invention.

[0122] Figure 14 is a side view of an alternative embodiment of a bypass catheter of the present invention in which the energy delivery member is concentrically mounted and expandable to include a waist defining a gap configured to receive target tissue.

[0123] Figure 14A yes Figure 14 A side view of an alternative embodiment of a bypass catheter including a valve positioned therein to inhibit blood flow through the bypass catheter.

[0124] Figure 14B yes Figure 14 Side view of an alternative embodiment of a bypass catheter in which the energy delivery member is mounted eccentrically and includes a valve for inhibiting blood flow therethrough in a first (e.g., proximal) direction.

[0125] Figure 14C yes Figure 14B 2 is a side view of an alternative embodiment of a bypass catheter in which the valve is configured to inhibit blood flow through the energy delivery member in a second (eg, distal) direction.

[0126] Figure 14D Demonstrated use Figure 14B Methods of treating target tissue (e.g., calcified heart valves) with a bypass catheter.

[0127] Figure 14E yes Figure 14B Side view of an alternative embodiment of a bypass catheter including a different valve.

[0128] Figure 15 yes Figure 14 Side view of an alternative embodiment of a bypass catheter in which an energy delivery member defines a passage extending therethrough.

[0129] Figure 15A yes Figure 15 Side view of an alternative embodiment of a bypass catheter comprising a valve positioned within a passageway.

[0130] Figure 16 yes Figure 14 Side view of an alternative embodiment of a bypass catheter.

[0131] Figure 16A yes Figure 14B Side view of an alternative embodiment of a bypass catheter comprising a valved proximal (first) energy delivery member and a (discrete) distal (second) energy delivery member.

[0132] Figure 17 yes Figure 14 Side view of an alternative embodiment of a bypass catheter in which the energy delivery member comprises an annular (ring) configuration.

[0133] Figure 18 yes Figure 17 1 is a side view of an alternative embodiment of a bypass catheter comprising a first energy delivery member and a second energy delivery member, each having an annular (ring) configuration.

[0134] Figure 19 yes Figure 14 Side view of an alternative embodiment of a bypass catheter in which the energy delivery member comprises a (substantially) planar (e.g., disc-shaped) configuration.

[0135] Figure 19A yes Figure 19 Side view of an alternative embodiment of a bypass catheter in which the energy delivery member is supported by a plurality of stents.

[0136] Figure 20 yes Figure 19 Side view of an alternative embodiment of a bypass catheter in which the energy delivery member is mounted eccentrically and includes a valve for inhibiting blood flow therethrough.

[0137] Figure 20A yes Figure 20 Side view of an alternative embodiment of a bypass catheter.

[0138] Figure 21 yes Figure 20 Side view of an alternative embodiment of a bypass catheter comprising a proximal (first) energy delivery member and a (discrete) distal (second) energy delivery member.

[0139] Figure 21A yes Figure 21 Side view of an alternative embodiment of a bypass catheter in which the proximal energy delivery member is movable via a pusher.

[0140] Figure 21B yes Figure 21A Side view of an alternative embodiment of a bypass catheter in which each of the proximal and distal energy delivery members is movable via a corresponding pusher.

[0141] Figure 22 yes Figure 14 A side view of an alternative embodiment of a bypass catheter including an impeller for directing blood flow through the bypass catheter.

[0142] Figure 22A yes Figure 22 Side view of an alternative embodiment of a bypass catheter.

[0143] Figure 23 yes Figure 12B Side view of an alternative embodiment of a bypass conduit in which the impeller is incorporated into (supported by) the energy delivery member.

[0144] Figure 24A is a perspective view showing the insertion of a delivery (external) catheter during surgery.

[0145] Figure 24B Is displayed through Figure 24A Insertion of the delivery catheter Figure 21 A perspective view of an alternative embodiment of a bypass (inner) catheter.

[0146] Figure 24C It is a display Figure 24B Perspective view of the deployment of the distal energy delivery member of a catheter.

[0147] Figure 24D It is a display Figure 24C Perspective view of the retraction of the delivery catheter and bypass catheter.

[0148] Figure 24E It is a display Figure 24D Perspective view of deployment of a proximal energy delivery member of a catheter and positioning of the distal energy delivery member near target tissue (e.g., a calcified valve).

[0149] Figure 24F It will show Figure 24E Perspective view of a catheter's proximal energy delivery member positioned near target tissue.

[0150] Figure 25 yes Figure 14 Schematic diagram of an alternative embodiment of a (bypass) catheter, and shown in a first (initial, normal) configuration.

[0151] Figure 26 It is along Figure 25 A transverse cross-sectional view of the bypass catheter taken along line 26-26.

[0152] Figure 27 yes Figure 25 Schematic diagram of a bypass catheter shown in a second (subsequent, deflected) configuration. DETAILED DESCRIPTION

[0153] In some embodiments, the present invention provides catheters and methods for use in a patient's blood vessels during a clot treatment procedure. The catheters advantageously provide blood flow during various clot treatment / removal procedures, such as mechanical thrombectomy using a rotating element to break up the clot, devices that deliver thrombolytic agents to dissolve clots, devices that deliver vibrational energy in the form of continuous or pulsed waves, devices that deliver energy to assist and / or achieve clot removal, and the like, as well as combinations thereof. These various embodiments are described in detail below.

[0154] The devices of the present invention provide blood flow control during surgery, enabling immediate and continuous (if needed) reperfusion during surgery. They allow, for example, the rapid restoration of temporary blood flow through an obstruction to avoid ischemic injury, where a degree of extra-clot blood flow is immediately restored. This allows additional time for treatment, such as removal or dissolution of a clot or other obstruction, while allowing flow to at-risk tissue.

[0155] Additionally, in the case of a large pulmonary embolism, there is the additional problem of cardiac burden due to the lack of outflow from the right side of the heart. The temporary bypass catheter described herein can also help reduce this cardiac burden when a large pulmonary embolism is present in the main pulmonary artery by allowing outflow from the right side of the heart to pass over the clot.

[0156] In some embodiments, the present invention provides a catheter for use in intraluminal lithotripsy and, in certain applications, for softening calcium in highly calcified valves, such as heart valves, as described in more detail below. For example, it is contemplated that the catheters described herein can be used preoperatively to soften any such calcium deposits.

[0157] Generally speaking, the devices of the present invention achieve this reperfusion by providing a catheter that is deployed across an obstruction in a blood vessel. In some embodiments, the catheter is a bypass catheter having a distal opening and at least one proximal intravascular opening that provides a bypass window, and when the catheter is positioned across the obstruction in the blood vessel, these openings are positioned within the blood vessel on either side of the blood clot to be treated. This allows blood to flow from the proximal area of ​​the clot to the distal area of ​​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. These various structures / features are discussed in detail below.

[0158] In some embodiments, the present invention utilizes elements of a temporary bypass catheter and balloon, a single lumen support catheter, and a rotary irrigation and aspiration thrombectomy device in its improvements.

[0159] In some embodiments, the device can further include a semipermeable filter circumferentially attached at or near its distal end to minimize the risk of embolism during surgery. The filter can be self-expanding. The filter can have different modalities to constrain and deploy as needed. In some embodiments, the filter can be attached to a wire that extends through the entire lumen of the device and is deployed distally within the blood vessel. In some embodiments, the filter is distal to the distal end hole and is tethered to the catheter.

[0160] Referring now to the Figures and Detailed Description of the Present Disclosure, in which like reference numerals identify similar structural features of the devices disclosed herein throughout the several views, several embodiments of the catheter of the present invention are shown.

[0161] 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 "device," "device," and "catheter" are used interchangeably herein. It should also be noted that the terms "aperture" and "opening" are used interchangeably herein.

[0162] As used herein, "blood clot treatment" includes any type of blood clot treatment, which may include partial removal of the clot, reduction of the size of the clot, complete removal of the clot, removal by mechanical thrombectomy, dissolution by medication, etc. The devices of the present invention may also be used for other vascular treatments, including removal of other intravascular debris and obstructions. Thus, as used herein, the terms "blood obstruction treatment" or "vascular obstruction treatment" include obstructions caused by clots or other obstructions.

[0163] Now refer to Figure 1, showing a first embodiment of a bypass catheter of the present invention. It should be noted that the catheter disclosed herein is also referred to as a device or apparatus. The catheter is generally indicated by the reference numeral (1a) and is in the form of an elongated member, preferably tubular, and has a proximal (end) hole (opening) (7) (attached to an external terminal device in some embodiments), a distal end hole (4) at the distal portion, and a side hole (bypass window) (2) provided on the outer diameter (i.e., in the wall (14) at the junction of the first (distal) section (5) and the second (proximal) section (6) of the device (1). It should be noted that sections (5) and (6) indicate two regions or parts of the catheter (1a), as the catheter (1a) can be a one-piece tubular structure as shown. However, alternatively, sections (5) and (6) can be composed of separate elongated tubular members attached / joined together. The side hole (2) defines the end of the second section (6), or at the proximal end of the section (5), and blood flows through the side hole (2) and out through the distal hole (4). In the illustrated embodiment, the outer diameters of the first segment (5) and the 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 of the segments may be tapered. Furthermore, while a single side port is shown in the drawings of the various embodiments, it is contemplated that more than one side port for blood inflow may be provided in the bypass catheters disclosed herein. Similarly, multiple outlet ports may be provided; however, when there are no intermediate vessel branches, a single end port is preferred to maximize laminar flow, minimize turbulence, and maximize flow rate and velocity.

[0164] The bypass catheter (1a) is introduced through an incision in a patient's blood vessel, most typically percutaneously, and is typically guided through the vascular system to the target site using standard intravascular techniques, with the aid of a wire (e.g., a guidewire) and / or a delivery catheter, typically under fluoroscopic guidance. The catheter can be inserted along a guidewire that passes through the proximal opening (7) and lumen (17) of the catheter (1a) and extends out from the distal opening (4). Although the lumen 17 is shown as including a circular (or substantially circular) transverse cross-sectional configuration (e.g., diameter), alternative configurations are also contemplated herein. For example, it is envisioned that the lumen 17 may include a non-circular (e.g., square, rectangular, hexagonal, octagonal, pentagonal, "house" shaped, elliptical, oval, star-shaped, etc.) transverse cross-sectional configuration. In the case of a star-shaped transverse cross-sectional configuration, any star pattern can be used, including, for example, a six-pointed star, a "Star of David," etc.

[0165] In some embodiments, the first or distal segment (5) has a structure for anchoring the device (1a) within the blood vessel to position and maintain the side hole (2) at a desired location. This structure may include, for example, expandable wires that expand to at least the size of the inner diameter of the blood vessel to secure the device (1a) in place. Alternatively, an expandable balloon such as a Figure 1 The balloon (8) is shown attached to the first section (5). The balloon (8) can also be used to regulate blood flow and thereby help control contact of any delivered medication with any clot. The balloon (8) is inserted in a contracted, collapsed state. After being inflated by injecting a fluid (liquid or gas) through a channel (15) in the catheter (1a) that communicates with the interior of the balloon (8), the balloon (8) expands from the collapsed state to an expanded state that at least reaches the inner diameter of the blood vessel, thereby anchoring the catheter (1a) in the desired position. It should be noted that the catheter (1a) may include a separate channel or lumen (15) (see Figure 1A ), which channel or lumen is used to inject an inflation fluid (e.g., saline) to expand the balloon (8), or in embodiments where a mechanical dilator is used instead of a balloon to anchor the catheter (1a), for the passage of a wire or other elongated mechanism for expanding the wire. In preferred embodiments, the additional lumen is within or substantially within the wall of the catheter, thereby minimizing any blockage within the main central lumen and maximizing blood flow through 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 in a radial direction relative to the wall or longitudinally along its length. The anchoring device (e.g., balloon (8)) is shown positioned between the side hole (2) and the distal hole (4), but alternatively may be positioned in other areas of the catheter, for example, proximal to the side hole (2) in the second (proximal) section (6). It should be noted that the anchoring structure may be provided on other bypass catheters disclosed herein. In some embodiments, no anchor is provided.

[0166] While the lumen 15 is illustrated as comprising a circular (or substantially circular) transverse cross-sectional configuration (e.g., diameter), alternative configurations are contemplated herein. For example, it is envisioned that the lumen 15 may comprise a non-circular (e.g., square, rectangular, hexagonal, octagonal, pentagonal, "house" shaped, elliptical, oval, star-shaped, etc.) transverse cross-sectional configuration. In the case of a star-shaped transverse cross-sectional configuration, any star pattern may be used, including, for example, a six-pointed star, a "Star of David," etc.

[0167] like Figure 1A As shown, lumen 15 is positioned within central lumen 17. Alternatively, lumen 15' ( Figure 1B) may be embedded or substantially embedded in the wall of the catheter section 5. The main central lumen for blood flow is indicated by reference numeral 17'. Alternatively, a lumen 15" ( Figure 1C ) may be adjacent to the wall of the catheter section 5 so that it shares the wall of the catheter section 5. The main central lumen for blood flow is indicated by reference numeral 17".

[0168] The device 1a of the present invention is positioned such that the side hole (2) is positioned to receive blood flow from the patient and direct the blood through the lumen (17) in the first section (5) and around the blood flow past the obstruction to exit through the distal hole (4). As described above, one side hole (2) is shown, however, it is also contemplated that more than one side hole (2) may be provided in the catheter 1a and other catheters described herein to provide more than one access channel for blood flow into the catheter at the proximal region of the vascular obstruction.

[0169] In some embodiments, there is at least one additional third proximal port having an attached external terminal device that remains external to the patient's body. When needed, suction from an external suction device can optionally be applied to the third proximal port to remove clots and debris from the blood vessel.

[0170] In some embodiments, the additional lumen is positioned within or substantially within the wall of the catheter and can take a spiral or corkscrew route within the wall to reach (extend to) the balloon, thereby potentially increasing the flexibility of the catheter. Similarly, any filaments (when present) used to transmit energy in the embodiments described below within the device (e.g., within the wall or substantially within the wall) can also take a similar spiral or corkscrew route within the wall in some embodiments. Alternatively, in some embodiments, the additional lumen for delivering fluids (such as drugs) to the perforations and / or for inflating and deflating the balloon can pass completely freely through the intravascular portion of the single main central lumen, except near the attachment portion of the perforation and balloon; in effect, the additional microcatheter passes through the outer catheter and is attached only distally.

[0171] It should be noted that in some embodiments, where there is an additional lumen passing through the intravascular segment of the elongated body, the device (preferably outside the patient's body) can be proximally divided into multiple lumens with independent outer walls. Preferably, each lumen terminates at its proximal end hole in an independent external terminal device, such as a port with a Luer lock or a septum.

[0172] The catheters of the present invention may include structures or features for preventing backflow of blood through lumen 17. Three alternatives are discussed below, which may be used alone, in combination, or in one or more combinations and may be used with any of the bypass catheter embodiments disclosed herein.

[0173] Figure 1 An embodiment is shown that utilizes a valve (3) disposed within the main central lumen at the junction of the second section (6) and the side hole (2). The valve (3) may take various forms, such as a leaflet valve, a baffle valve, etc. The valve may be configured to allow blood to flow in one direction (i.e., distally) thereby preventing flow in the proximal direction without any clinician intervention. Alternatively, the valve may be configured to open upon clinician intervention. For example, in Figure 1 In an embodiment, once the device (1) is positioned in a desired location near a blood clot to be treated (e.g., removed), the valve (3) is closed by the user (clinician) to prevent blood entering 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), with the controller being attached to the valve by a wire or other elongated member. By closing the valve (3), blood is thereby directed through the first segment (5), through the lumen (17) of the segment (5) and out the distal end hole (4), and is allowed to perfuse the tissue at risk. Alternatively, the valve can be in a default closed position and open when a wire is passed through it, and then automatically close when the wire is removed.

[0174] During use of the device (1), the distal segment (5) is placed across a target tissue (e.g., a clot, a calcified heart valve, etc.), and blood can then bypass the target tissue through the distal segment (5) (depending on the direction of blood flow). For example, it is contemplated that blood can flow through the side hole (2), through the distal segment (5), and out of the distal end hole (4), or blood can flow through the distal end hole (4), through the distal segment (5), and out of the side hole (2). The device (1) is configured such that the proximal end hole (7) is positioned outside the patient's body (e.g., to allow aspiration of debris, clotted material, etc. through the hole), whereby the proximal segment (6) is not used for bypass surgery.

[0175] In certain methods of use, if the side port (2) is covered (e.g., by the patient's tissue), the shunt will be closed and blood will not flow through the device (1). However, it is contemplated that blood may flow back or be actively aspirated out of the body (e.g., via the proximal port (7)) in order to establish blood flow.

[0176] exist Figure 2In the depicted alternative embodiment, the inner diameter (10) of the second segment (6) is smaller than the inner diameter of the first segment (5), rather than the valve. That is, the inner wall of the second segment (6) is thicker to provide a lumen with a smaller diameter than the lumen of segment (5), or the second segment (5) can have a smaller diameter, thereby forming a smaller lumen. The inner diameter (10) terminates at the inner hole (11). As shown, the inner hole (11) is smaller than the distal end hole (4). The difference in inner diameter acts to limit backflow and guide blood through the first segment (5) to and out of the end hole (4). Figure 2 The duct (1b) is at all other levels Figure 1 The catheter (1a) is identical to the catheter of FIG. 1 and may optionally include an anchoring structure, such as a balloon (8) and a valve, but in a preferred embodiment does not have a valve.

[0177] In some embodiments, the valve (3) and the reduced inner diameter (10) and inner orifice (11) are used to limit the backflow of blood. As described above, the valve can be configured to allow blood to flow in one direction in its natural state, or alternatively, the valve can be manipulated by a clinician between an open position (allowing blood flow) and a closed position (restricting blood flow when desired).

[0178] exist Figure 3 In yet another embodiment depicted in , pressurized fluid may be introduced into the second section (6) to prevent backflow of blood. Figure 3 The device (1c) is depicted as being connected to a pressurized fluid bag (12) which is coupled to the proximal port (7) via tubing (13), appropriate connectors, and an external terminal at the proximal port. Other sources of pressurized fluid are also contemplated, such as an injection device. The proximal port (7) is connected to the first section (5) via a lumen extending therethrough, through the second section (6). The pressurized fluid bag (12) may be connected to a flow regulator outside the patient's body to allow the user of the device to control the flow of fluid through the second section (6). A pressure gauge may also be provided to regulate the pressure of the fluid being delivered through the catheter. Figure 1 Like the catheter (1a), Figure 3 The catheter (1c) has a side hole (2) for blood entry to bypass the obstruction and a distal hole (4) as described above.

[0179] Pressurized fluids can be used alone or in combination with Figure 3The valve (3) is shown in combination with and / or in combination with a reduced diameter inner hole (11) to prevent backflow of blood through the segment (6). In other words, the pressurized fluid, the valve (3) and the differential inner diameter (10) and inner hole (11) can all be used simultaneously, or only one or only two of these features can be used in the catheters disclosed herein. In some embodiments, the outer diameters of the proximal segment (6) and the distal segment 5 can also be different. When used in combination with an expandable sheath (such as the e-sheath manufactured by Edwards Lifescience), this can be particularly useful to limit the sheath size required to introduce the larger diameter distal segment (6) into the lesion.

[0180] In some embodiments, a balloon (as described below) can be positioned on the catheter or sheath and can be selectively inflated if flow arrest and / or flow reversal is desired during a clot treatment procedure (e.g., a pulverization procedure) to prevent clot spread, or to aspirate clot and debris.

[0181] In some embodiments, the catheter may have a filter or distal protection device at the distal portion. Figures 9 to 11 Three embodiments of such filters mounted in different ways are shown. It should be noted that these filters can be used with any embodiment of the device (catheter) disclosed herein, and Figures 9 to 11 Some examples of such catheters are shown.

[0182] exist Figure 9 In the embodiment of the present invention, the filter 101 is attached to the distal end of the catheter 100, terminating at the end hole 104. As with other catheters disclosed herein, the catheter 100 has a proximal opening 107, a side hole 102 for blood inflow (such as Figure 1 The side hole 2) and the distal end hole 104 for blood to flow out in the bypass manner disclosed herein. Figure 10 In the embodiment of the present invention, filter 111 is tethered to the distal end of catheter 110 and is therefore positioned distally of distal port 114. Wire 111b is attached to the distal region of catheter 110 and extends distally thereof. Like other catheters disclosed herein, catheter 110 has a proximal opening 117, a side port 112 (such as side port 2) for blood inflow, and a distal port 114 for blood outflow in the bypass manner disclosed herein. Figure 11 The embodiment of FIG. 1 shows a distal filter 130 for use with a catheter having an energy emitter. Figure 11 .

[0183] During use of the catheter 100, 110, its distal portion is placed across the target tissue (e.g., a clot, a calcified heart valve, etc.), and blood can then 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 the side holes 102, 112, through the distal region, and out the distal end holes 104, 114, or blood can flow through the distal end holes 104, 114, through the distal region, and out the side holes 102, 112. The catheters 100, 110 can be configured such that the respective proximal openings 107, 117 are positioned external to the patient (e.g., to allow aspiration of debris, clotted material, etc. through the openings), such that the proximal region of the catheters 100, 110 is not used for bypass surgery.

[0184] In certain methods of use, if the corresponding side holes 102, 112 are covered (e.g., by the patient's tissue), the shunt will be closed and blood will not flow through the catheters 100, 110. However, to establish blood flow, blood may flow back or be actively aspirated out of the body (e.g., via the corresponding proximal openings 107, 117).

[0185] Filters 101, 111, and 130 can have silk, mesh, braid, or other filter materials 101a, 111a, 131, respectively, to block / catch particles from moving downstream in the blood vessel while allowing blood to flow through the filter. Multiple silk threads 101b, 111b, 133 are expandable to move filters 101, 111, 130 from a collapsed state (for delivery to the distal end of the obstruction) to an expanded state. The filter can be self-expanding or can be manually controlled by silk threads connected to silk threads 101b, 111b, 133 and can be selectively actuated in the proximal region of a catheter outside the patient's body.

[0186] A semipermeable filter is attached circumferentially at or near the distal end of the catheter to minimize the risk of embolism during surgery. The filter can have different modalities to constrain and deploy as needed. In some embodiments, the filter can be attached to a wire that extends through the entire lumen of the device and is deployed distally within the blood vessel. The filter can be configured as shown or have other shapes / configurations.

[0187] Figure 4 An alternative embodiment of the catheter of the present invention is shown, wherein the first section (5) is perforated with at least one perforation (30). The perforation (30) of the bypass catheter (1d) is an end hole, i.e., an exit hole, which is separated from a separate lumen or channel (36) within the catheter (1d) ( Figure 4A) is connected. Channel (36) provides an independent flushing (fluid) channel that extends to the proximal end hole (7) and is connected to the controller (38) via a pipe (37) for controlling the flow of fluid through the channel (30). The fluid is introduced into the separate channel (36), flows through the channel (36) extending through segments (5) and (6), and flows out of the perforation (30) to flow into the blood vessel (and in particular the blood clot) to dissolve the blood vessel occluding material of the clot. For example, the fluid can be a drug, such as a lytic agent that dissolves blood clots, such as alteplase. The controller (38) is capable of controlling / regulating the flow of the drug from the controller through the lumen (36) and out of the perforation (30) to achieve the dissolution of the clot near the first segment (5). Alternatively, other methods can be used, such as manual injection via a syringe. The drug has the ability to soften and / or change the chemical composition of the blood clot near the perforation (30), thereby achieving the purpose of removing and / or dissolving the clot or other obstruction. In order to enhance the dissolution, an energy source can be provided, which will be combined below Figure 6 Provide a detailed description.

[0188] Although the lumen of the catheter disclosed herein is shown as comprising a circular (or substantially circular) transverse cross-sectional configuration (e.g., diameter), alternative configurations are contemplated herein. For example, it is contemplated that the lumen 36 may comprise a non-circular (e.g., square, rectangular, hexagonal, octagonal, pentagonal, "house" shaped, elliptical, oval, star-shaped, etc.) transverse cross-sectional configuration. In the case of a star-shaped transverse cross-sectional configuration, any star pattern may be used, including, for example, a six-pointed star, a "Star of David," etc.

[0189] 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, as Figure 4 As shown, one or more perforations (30) may be provided proximal to the side hole 2. The fluid flowing out of the perforations (30) may affect the proximal region of the blood clot. Figure 4 In the embodiment, the side holes (2) are shown in the middle region of the segment (5), however, it should be understood that the side holes (2) can be provided in other regions along the conduit (1d), such as in Figure 1 In the embodiment of the present invention, it is provided in the proximal region of segment (5). A valve 3 or other flow restricting structure may be provided.

[0190] Figure 4 The device (1d) may be constructed of concentric lumens wherein the channel (36) for drug flow communicating with the perforation (30) is located in the center of the lumen (17). In an alternative embodiment, the channel is positioned within the main lumen but offset from the center and substantially along the wall of the catheter. Figure 4B In another embodiment shown, the fluid delivery lumen leading to the perforation is substantially through the wall of the intravascular section of the catheter. More specifically, in Figure 4C In FIG, the channel 36 is shown adjacent to the wall of the conduit section 5, so that it has a common wall with the conduit. Figure 4A In an alternative embodiment, a channel 36', which functions similarly to channel 36, is positioned offset from the center within the main central lumen 17' of the catheter segment 5, which functions similarly to lumen 17. Figure 4C In the embodiment of the present invention, a channel 36 ″, which functions similarly to the channel 36 , is embedded in the wall of the catheter section 5 . A main central lumen, which functions similarly to the lumen 17 , is indicated by reference numeral 17 ″.

[0191] In some embodiments, the perforations (30) are in communication with an area between the inner surface of the outer lumen and the outer surface 36 of the inner lumen, with the gap extending from the perforations (30) to the proximal end hole (7) and in communication with the controller (38). This allows medication from the controller (38) to pass through the area between the inner surface of the outer lumen and the outer surface of the inner lumen and be pumped out of the perforations (30) to allow medication to be infused to soften, dissolve or change the composition of the clot or obstruction. In a preferred embodiment, the inner channel (or the area between the inner surface of the outer lumen and the outer surface of the inner lumen) terminates at the distal-most perforation (30) at the end (32). Alternatively, the inner channel can terminate at or near the end hole (4) in the first section (5). In an alternative embodiment, in place of or in addition to the perforations, there can be one or more slits in the surface of the catheter through which the fluid medication is delivered.

[0192] Now refer to Figure 5, alternative embodiments of the device of the present invention further include rotating, crushing and flushing elements. More specifically, the bypass catheter 10 includes a slidable outer support sheath (60) having a proximal opening (67), a crushing element or ring (70) and / or perforations (30) that serve as flushing elements to allow fluid (such as a drug for dissolving blood clots) to flow out. The slidable outer support sheath (60) provides a hole covering member and is capable of tightly closing the side hole (2) when the first section (5) is pulled into the interior of the sheath (60) (moving proximally) or the sheath 60 is advanced (moving distally) to cover the side hole (2) or when the sheath 60 moves distally and the first section (5) moves proximally. Each of these variations can be considered relative movement. In any of these methods, this relative movement is used to achieve opening (exposing) and closing (covering) the side hole (2) according to the needs of the clinician. The movement of the sheath (60) is controlled at the proximal end, and the movement of the first section (5) is controlled by the movement of the catheter 10, which is also controlled at the proximal end. When the side hole (2) is closed, the intravascular contents can be aspirated through the end hole (4) by applying external suction at the proximal end hole (7). It should be noted that in alternative embodiments, the sheath used to cover the side hole can be positioned inside the catheter, rather than on the outside of the catheter. Such an external or internal sheath can be used with any of the embodiments disclosed herein.

[0193] A comminuting element (70) extends radially from the catheter (10) and is preferably positioned between the lateral port (2) and the distal port (4). When the catheter 10 is rotated to rotate the element (70), the comminuting element (70) comminutes the clot. This rotation may occur simultaneously with the infusion of medication through the perforations (30) to also aid in mixing or movement of the medication. While the comminuting element is shown in the form of a ring (70), other comminuting configurations are also contemplated. Figure 8 In the illustrated alternative embodiment, the comminuting element rotates independently of the catheter, rather than being rotatable by the catheter. Figure 8 As shown, a pulverizing element 74 is in the form of a wire that extends radially from the bypass catheter 72 and is mounted on a rotating shaft 75. The shaft 75 extends through the lumen 77 and can be rotated manually, or alternatively by a motor 73 positioned inside the catheter or alternatively outside the catheter, to break up the clot. During pulverization, blood flows through the side holes 78, through the lumen 77, and out the distal hole 76 to bypass the blood clot. Perforations (such as Figure 5 The perforation 30 is used for fluid, such as drug injection. A sliding member (such as a sheath) can be provided to selectively cover the side hole 78.

[0194] While lumen 77 is illustrated as comprising a circular (or substantially circular) transverse cross-sectional configuration (e.g., diameter), alternative configurations are contemplated herein. For example, it is contemplated that lumen 77 may comprise a non-circular (e.g., square, rectangular, hexagonal, octagonal, pentagonal, "house" shaped, elliptical, oval, star-shaped, etc.) transverse cross-sectional configuration. In the case of a star-shaped transverse cross-sectional configuration, any star pattern may be used, including, for example, a six-pointed star, a "Star of David," etc.

[0195] return Figure 5 The catheter (10) further comprises a suction controller (39) which is in communication with the proximal end hole (7) via a conduit (39a). This suction is used to achieve a backflow of blood through the catheter (10). More specifically, when the side hole (2) is not covered by the sheath (60), the catheter performs its bypass function, wherein blood flows through the side hole (2) and out of the distal end hole 4 in the same manner as the side hole 2 and distal hole 4 in the aforementioned embodiment to bypass the vascular obstruction. When the side hole (2) is covered by the external support sheath (60) and suction is activated via the controller (39), since the suction controller (39) is in communication with the proximal end hole (7), this changes the blood flow bypass from the side hole (2) through the distal end hole (4) to directing blood from the distal end hole (4) out of the proximal end hole (7).

[0196] The device (10) may also include a regurgitant valve, such as valve (3) or other reverse flow limiting features / structures described herein. A balloon (50) may be provided that is inflatable by an inflation fluid injected through a passage (52) in the catheter (10) to expand to a diameter equal to or slightly greater than the inner diameter of the vessel, thereby providing an anchoring force to secure the catheter in place and / or control flow in the vessel. It should be noted that in the illustrated embodiment, the balloon (5) is proximal to the side hole (2), but may be positioned elsewhere. Alternatively, other mechanical anchoring elements may be provided as described above.

[0197] If the operator chooses to aspirate from the distal end hole (4), the bypass catheter (10) can be pulled back (or the sheath (60) moved forward, or both moved relative to each other) so that the side hole (2) is temporarily positioned within the sheath (60), which is sized to fit snugly around the bypass catheter (10) and the suction force applied at the proximal hole (7) will be transferred to the proximal end hole (4) as long as the valve (3) (if any) is open during aspiration. It is important to note that for optimal use of this embodiment of the invention, the first section (5) fits snugly inside the slidable outer support sheath (60), or at least has minimal clearance, so that when the sheath (60) covers the side hole (2), the inflow of blood through the side hole 2 is inhibited or completely restricted.

[0198] It should be understood that in alternative embodiments, to close the side hole (2), the hole covering member can be an inner member slidably disposed within the lumen of the device (10) and can be moved distally, or the device 10 can be retracted proximally, or both can be moved relative to each other, so that the outer wall of the inner member covers the side hole 6, preferably tightly enough to reduce or close the gap between the outer wall of the inner member and the inner wall of the device 10 to restrict blood flow therein.

[0199] Figures 6 to 7A Alternative embodiments of the bypass catheter of the present invention are presented in which energy is applied to treat blood clots, for example, to disrupt or dissolve clots. The energy can be used in conjunction with clot-dissolving medications, or alternatively, can be used without such medications, relying instead on mechanical clot disruption. In some embodiments, ultrasound waves are transmitted. Various frequencies of ultrasound can be utilized. Some frequencies are optimized for clot dissolution, some for drug delivery into clots, some for calcium softening, some for calcium dissolution, some for calcium disruption, and some for other uses.

[0200] First look Figure 6 The 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 the device 80. As described above, the bypass catheter 80 can be considered to have two sections or parts, namely, integral or separately joined components. The bypass catheter 80 in this embodiment has three channels (lumens): i) a main channel 85a, which allows blood to enter through the side hole 88 in the wall of the catheter 80 to flow out of the distal hole 86, thereby bypassing the blood clot for immediate perfusion; ii) a channel 85b for injecting a drug (such as a thrombolytic agent) from a fluid source B to dissolve the clot; and iii) a channel 85c for containing a wire 89 that connects the ultrasound source A to an energy emitter (radiating element) 87 disposed on the catheter 80 (e.g., along the catheter). It should be noted that these three lumens 85a, 85b, 85c are provided as examples only, as in alternative embodiments, the filament 89 can be positioned in the fluid channel 85b, in which case the catheter 80 would have two lumens instead of three. Alternatively, the filament 89 can be embedded or substantially embedded in the wall of the catheter 80. In a preferred embodiment, both the filament and the additional lumen for fluid / drug delivery are completely or substantially embedded within the wall of the intravascular segment of the catheter. This arrangement limits obstruction to the flow of blood through the catheter in the bypass segment, thereby maximizing blood flow and perfusion to the distal vascular region during periods of vessel occlusion due to an obstruction and during periods of vessel occlusion due to an inflated balloon or other obstruction. Figure 6Ais a transverse cross-sectional view of catheter 80 illustrating one possible arrangement of lumens, however, it should be understood that other arrangements of lumens and sizes of lumens may vary from those shown.

[0201] Although Figure 6A The lumens disclosed in the present invention and the lumens disclosed in each of the other embodiments described and illustrated in the accompanying drawings are shown as including a circular (or substantially circular) transverse cross-sectional structure (e.g., diameter), but alternative configurations are also contemplated herein. For example, it is envisioned that the lumens can each include a non-circular (e.g., square, rectangular, hexagonal, octagonal, pentagonal, "house" shaped, elliptical, star-shaped, etc.) transverse cross-sectional configuration. In the case of a star-shaped transverse cross-sectional configuration, any star pattern can be used, including, for example, a six-pointed star, a "Star of David," etc. These different lumen configurations are applicable to each of the catheters disclosed herein.

[0202] During use of catheter 80, its distal portion is placed across target tissue (e.g., a clot, a calcified heart valve, etc.), and blood can then 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 hole 88, through the distal region, and out of distal end hole 86, or blood can flow through distal end hole 86, through the distal region, and out of side hole 88. Catheter 80 can be configured so that its proximal end is positioned outside the patient (e.g., to allow aspiration of debris, clotted material, etc. through the proximal end), whereby the proximal region of catheter 80 is not used for bypass surgery.

[0203] In some methods of use, if side hole 88 is covered (e.g., by the patient's tissue), the shunt will be closed and blood will not flow through catheter 80. However, to establish blood flow, blood may flow back or be actively aspirated out of the body (e.g., via the proximal end of catheter 80).

[0204] and Figure 1 and Figure 4 Similar to the secondary lumen of the elongated member, several alternative embodiments (not shown) are possible, including various arrangements in which the secondary and tertiary lumens are incorporated or substantially incorporated into the wall of the elongated member. Alternatively, the secondary lumen can be or substantially within the wall, and the tertiary lumen can pass through the main central lumen, or vice versa.

[0205] Ultrasonic source A provides ultrasonic energy to energy emitter 87 via wire 89, such that the flow of drug within the clot is enhanced. It should be noted that, as an example, only three energy emitters (also referred to as energy emitting elements) are shown, as fewer or additional numbers of emitters may be provided, and spacing along the length of catheter 80 other than that shown may be used. Furthermore, the emitters 87 shown are positioned in a longitudinal row on one side of the catheter 80, but additional emitters may be provided on other sides of the catheter, for example, a series or longitudinal row of emitters provided on the side of the catheter, spaced 180 degrees apart from the emitters 87 shown. It is also contemplated that a series of emitters may be radially spaced along the outer wall of the catheter 80, rather than longitudinally spaced as shown. It is also contemplated that any combination of arrangements on the catheter and / or in the catheter and on one or more balloons and / or in one and / or more balloons are provided. Figure 6 In the embodiment of the present invention, the energy emitter 87 is near the opening 83 for delivering drugs or therapeutic agents to the blood clot. In an alternative embodiment, the energy emitter can be spaced apart from the opening 83.

[0206] In a preferred embodiment, as shown, the transmitter 87 is positioned between the lateral port 88 and the distal port 86. However, it is also contemplated that one or more energy transmitters 87 may alternatively or additionally be placed proximal to the lateral port 88. This may provide ultrasound energy to the region of the blood vessel proximal to the clot.

[0207] The wire 89 transmits the ultrasonic energy from the ultrasonic transducer A to the transmitter 87, as shown in FIG. Figure 6A Schematically shown in FIG, the transducer is remote from the transmitter 87. However, in alternative embodiments, the transmitter may include ultrasonic transducers (which convert electrical energy into ultrasonic energy) connected to an electrical energy source via a wire. The ultrasonic energy may be emitted as a continuous wave and / or a pulsed wave and in various waveforms, such as a sine wave. Various frequencies are also contemplated. A microcontroller may be provided to control the output. Alternative forms of energy are also contemplated.

[0208] A temperature sensor may be provided on or near the emitter 87 to monitor the temperature of the radiating element 87 or tissue during surgery. A cooling element may be provided.

[0209] In use, the bypass catheter 80 is typically inserted in a minimally invasive manner and advanced through a blood vessel to be placed near a clot, such that the side hole 88 is positioned proximal to the clot and the distal end hole 86 is positioned distal to the clot, as in the bypass catheter discussed above. This allows blood to flow from the proximal side of the clot through the clot to provide immediate and continuous (if necessary) blood flow (and tissue reperfusion) during surgery and while the catheter remains in place. The drug source is opened by a valve or switch on the catheter 80, or by opening at a remote location on or near the drug source B to allow drug flow. The radiating element (emitter) 87 is also activated by a switch on the catheter 80 or a remote switch (e.g., at the energy source), and energy is applied to the emitter 87 via a wire 89, thereby applying ultrasonic energy to the clot and / or blood vessel (generating an acoustic field) to increase the permeability of the clot, thereby improving the efficacy of the drug in dissolving the clot as it is driven deeper into the clot. This activation enhances the mixing of the drug via pressure waves and / or cavitation. In some embodiments, the ultrasonic energy and fluid injection can be synchronized so as to be performed simultaneously. Alternatively, the energy and fluid injection can be applied at separate times / intervals. During the application of ultrasonic energy and drug delivery, the side holes 88 remain open, allowing blood flow to continue to flow to the distal side of the clot, thereby avoiding blood interruption that could cause ischemia or other adverse conditions.

[0210] It should be noted that in alternative embodiments, ultrasonic energy can be used without injecting a drug. In such embodiments, the pulsed sound waves generated by the ultrasonic energy source and emitted by the radiating element 87 mechanically disrupt the clot by causing it to break up via cavitation. In alternative embodiments, rotational disintegration can also be used to mechanically disrupt the clot. As previously mentioned, aspiration of the clot and debris can also be optionally performed. Combinations of various techniques can also be performed simultaneously and / or sequentially.

[0211] exist Figure 7 In an alternative embodiment, a pulse or shock wave generator C is connected to the device (bypass catheter) 90. This generator generates shock waves that propagate through the blood clot to break up the clot. In some embodiments, the pulse generator C can be used in conjunction with a drug to break up the clot. As described above, the shock waves can alternatively be used to break up calcium or other hardened materials.

[0212] More specifically, device 90 has one or more energy emitters 97 in the form of electrodes. As with device 80, device 90 has a distal outlet (end) hole 96 and at least one side hole 98 on the outer wall of device 90. As described above, bypass catheter 90 can be viewed as having two sections or parts, i.e., integral or separately joined components. As with device 80, bypass catheter 90 in this embodiment has three channels (lumens): i) a main channel 95a for fluid to bypass blood clots; ii) a channel 95b for injecting a drug (such as a thrombolytic agent) from fluid source B (via tubing 91) to dissolve the clot; and iii) a channel 95c for containing a filament 99 that connects generator C to electrode 97 disposed on catheter 90 (e.g., along the catheter). As described above with respect to lumens 85a, 85b and 85c, lumens 95a, 95b, 95c are provided only as examples, and the variations described above with respect to lumens 85a, 85b and 85c and with respect to the wire are fully applicable to lumens 95a, 95b and 95c of catheter 90, such as embedded in the wall of the catheter, centrally located, offset from the center, etc.

[0213] During use of catheter 90, its distal portion is placed across target tissue (e.g., a clot, a calcified heart valve, etc.), and blood can then 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 98, through the distal region, and out of distal end hole 96, or blood can flow through distal end hole 96, through the distal region, and out of side holes 98. Catheter 90 can be configured so that its proximal end is positioned outside the patient (e.g., to allow aspiration of debris, clotted material, etc. through the proximal end), whereby the proximal region of catheter 90 is not used for bypass surgery.

[0214] In some methods of use, if side hole 98 is covered (e.g., by the patient's tissue), the shunt will be closed and blood will not flow through catheter 90. However, to establish blood flow, blood may flow back or be actively aspirated out of the body (e.g., via the proximal end of catheter 90).

[0215] and Figure 1 and Figure 4 Similar to the secondary lumen of the catheter, several alternative embodiments are also contemplated, including various arrangements in which the secondary and tertiary lumens, electrodes, or wires, or a combination thereof, may be incorporated or substantially incorporated into the wall of the elongated member. Alternatively, the secondary lumen may be within or substantially within the wall of the catheter and the tertiary lumen may pass through the main central lumen, or vice versa.

[0216] Generator C provides a voltage pulse (shock wave) that is transmitted through a connector or wire 99 to an energy emitter (electrode) 97, causing the shock wave to propagate through the blood vessel and strike the blood clot, thereby breaking up the blood clot. It should be noted that, as an example, only three energy emitters are shown, as fewer or additional emitters can be provided, and spacing along the length of the catheter 90 other than that shown can be used. In addition, the emitters 97 are shown positioned in a longitudinal row on one side of the catheter 90, but additional emitters can also be provided on other sides of the catheter, for example, a series or longitudinal row of emitters on the side of the catheter, spaced 180 degrees apart from the emitters 97 shown. It is also contemplated that a series of emitters can be radially spaced along the outer wall of the catheter 90, rather than longitudinally spaced as shown.

[0217] As with device 80 , generator C may be used in conjunction with drug flow through perforations 93 , and energy emitters 97 may be positioned proximate to, or alternatively spaced apart from, openings 83 to deliver the drug or therapeutic agent to the clot.

[0218] In a preferred embodiment, as shown, the emitter 97 is positioned between the lateral port 98 and the distal port 96. However, it is also contemplated that one or more energy emitters 97 may alternatively or additionally be placed proximal to the lateral port 98. This may provide shock waves to the region of the blood vessel proximal to the clot.

[0219] A microcontroller may be provided to control the output. A temperature sensor may be provided on or near the transmitter 97 to monitor the temperature of the electrode or tissue during surgery. A cooling element may be provided.

[0220] Aside from the delivery of shock waves, bypass catheter 90 can be inserted and used in the same manner as catheter 80, and thus the description of the use of device 80 also applies 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 clot, thereby avoiding interruption of blood flow that could result in ischemia or other adverse conditions.

[0221] It should be noted that in other embodiments, energy can be used without injecting a drug. In such embodiments, the shock waves generated by the energy source and emitted by the electrodes 97 break up the clot via cavitation, thereby mechanically breaking up the clot.

[0222] In some embodiments, the balloon can be placed over the energy emitter and the pulses can be provided within the balloon. In some embodiments, in addition to or instead of being within the balloon, the energy emitter can be placed over the balloon and the pulses can be provided within or on the balloon. These external emitters, such as Figure 11, wherein an energy emitter 124 (e.g., an electrode) is placed on a balloon 125 attached to a catheter 120. Like other bypass catheters disclosed herein, the catheter 120 includes a side hole 122 and a distal end hole 126 for blood bypass. The catheter also has a main lumen for blood flow and a secondary lumen for inflation of the balloon 125. The balloon 125 and the energy emitter 124 are positioned between the side hole 122 and the end hole 126, and these emitters emit energy into the blood vessel. The 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 emitters can be in various forms disclosed herein.

[0223] During use of the catheter 120, its distal portion is placed across the target tissue (e.g., a clot, a calcified heart valve, etc.), and blood can then 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 the side hole 122, through the distal region, and out of the distal end hole 126, or blood can flow through the distal end hole 126, through the distal region, and out of the side hole 122. The catheter 120 can be configured so that its proximal end is positioned outside the patient (e.g., to allow aspiration of debris, clotted material, etc. through the proximal end), whereby the proximal region of the catheter 120 is not used for bypass surgery.

[0224] In some methods of use, if side hole 122 is covered (e.g., by the patient's tissue), the shunt will be closed and blood will not flow through catheter 120. However, to establish blood flow, blood may flow back or be actively aspirated out of the body (e.g., via the proximal end of catheter 120).

[0225] The catheter 120 in the illustrated embodiment has a filter 130, however, it should be understood that the catheter 120 may be provided without a filter. The filter 130 is attached to a wire 128 that extends the length of the catheter so that the clinician can access it outside the patient's body at region 128a. The wire 133 supports the filter material 131, and the filter terminates at region 132. Figure 9 and Figure 10 Like filters 101 and 111 , filter 130 may alternatively be attached or tethered to catheter 120 , respectively.

[0226] If interruption of blood flow through the clot is desired, a sheath (such as Figure 5 The sheath 60 (or internal blocking member) is used to selectively open and close the side holes 88, 98, 122 of the catheters 80, 90, 120 (or the side holes of any other catheters disclosed herein). In some embodiments, the catheters 80, 90, 120 can be connected to a suction source (such as the one described above in conjunction with Figure 5A suction source 39 is provided for the catheters described above to provide suction when necessary to achieve backflow of blood through the catheters 80, 90.

[0227] Catheters 80, 90, 120 (and other catheters disclosed herein) can include structures such as those described above (e.g., valves, restrictive openings, etc.) to limit backflow through the catheter. As with the above-described alternative embodiments, catheters 80, 90, 120 can also include an anchoring structure, such as a wire or an inflatable balloon.

[0228] Various forms of energy can be provided to the bypass catheters described herein, such as ultrasonic energy, electrosurgical energy in the form of radiofrequency or microwave energy, etc. Additionally, other types of energy can be applied, including light or laser energy.

[0229] As described above, energy can be applied between the lateral and distal ports to treat the clot while blood bypasses the clot, thereby providing immediate tissue reperfusion. That is, in a preferred embodiment, various forms of energy and associated energy emitters or openings for energy emission are positioned between the lateral and distal exit ports. However, in alternative embodiments, instead of applying energy between the lateral and distal ports, the energy emitters or openings can be positioned proximal to the lateral ports and / or have structures (e.g., antennas or other energy emitting devices) extending distally of the distal ports. When used in conjunction with medication, immediate reperfusion is beneficial because the clot will dissolve over time due to the thrombolytic infusion.

[0230] In an alternative embodiment, a mechanical thrombectomy device having at least one wire or other pulverizing structure is positioned at a position such as at Figure 8 The clot is broken by a motor (in an embodiment of the present invention) within the catheter, or alternatively by a motor external to the catheter. The pulverizing element is mounted on a rotating shaft that rotates about its axis upon activation of the motor, causing the pulverizing element to break up the clot. In a preferred embodiment, the pulverizing element is positioned between the proximal and distal apertures, however, it may alternatively be mounted in other locations. Alternatively, a pulverizing wire may be mounted on the catheter, and the entire catheter may be rotated to perform the pulverization.

[0231] In some embodiments, the catheter may have a complex shape for the second catheter segment or a portion of the catheter, wherein rotation of the catheter itself may cause comminution. An example of such a complex shape is a sinusoidal shape.

[0232] The bypass catheter disclosed above has a side hole and a distal hole for blood to bypass blood clots or other blood vessel obstructions. Figure 12In an alternative embodiment, the spherical ball balloon is provided with a passage for blood flow when the balloon is inflated. One type of balloon that can be used is the expandable spherical ball balloon disclosed in U.S. Patent No. 10,328,246, the entire contents of which are incorporated herein by reference. Other balloon shapes are also contemplated.

[0233] An energy source (such as those described herein) can provide energy to transmitters (e.g., electrodes) positioned on or in an inflatable spherical balloon. This can be used during valvular lithotripsy while allowing blood to flow out of the heart through the central hole of the balloon during prolonged balloon inflation for prolonged contact with the valve, or similarly, continued blood flow through a blood vessel during intravascular use without severe blockage of blood flow.

[0234] Figure 12 A catheter 140 is shown that includes: a catheter body 142 having a (main, working) lumen 143 extending therethrough, the lumen being configured to receive one or more ancillary medical devices (e.g., catheters, instruments, tools, etc.) 54; and an energy delivery member 155 supported by the catheter body 142 (e.g., mounted on or otherwise secured to the catheter body) such that the energy delivery member 155 extends radially outward therefrom. In the illustrated embodiment, the energy delivery member 155 is configured as an expandable member (e.g., a balloon) 149 and includes a body 159 having a cylindrical (or substantially cylindrical) configuration that defines opposing (e.g., proximal and distal) end faces 158i, 158ii. In the illustrated embodiment, the end faces 158i, 158ii each include a planar (or substantially planar) configuration, but non-planar surfaces are also contemplated. It should be understood that alternative configurations of the energy delivery member 155 are also contemplated herein, as described in further detail below.

[0235] The energy delivery member 155 defines a passage 153 that is configured to receive the catheter body 142 so that the catheter body 142 extends through the passage as shown. The region of the catheter 140 distal to the energy delivery member 155 is indicated by reference numeral 145, and the region of the catheter 140 proximal to the energy delivery member 155 is indicated by reference numeral 146. It should be understood that the energy delivery member 155 can 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 fluidically connected by a lumen 143 (e.g., a main central lumen). The port 150 is used to inject a fluid (liquid or gas) to expand (e.g., inflate) the energy delivery member 155.

[0236] The energy delivery member 155 includes a passageway 156 (e.g., an opening, a channel, a conduit, etc.) extending through the body 159 in a parallel (or substantially parallel) relationship to the longitudinal axis X1 defined by the catheter body 142 to allow blood (e.g., after expansion) to flow through the energy delivery member 155 during the surgical procedure. Figure 12 156 as being centrally positioned in the particular embodiment seen in FIG, it is also contemplated that the passageway 156 may be positioned eccentrically (e.g., such that the passageway 156 is radially offset from the center of the energy delivery member 155), as described in further detail below.

[0237] The energy delivery member 155 is mounted eccentrically, whereby the energy delivery member 155 and the passage 156 are each radially offset from (not aligned with) the longitudinal axis X1 defined by the catheter body 142 (e.g., such that a majority (greater than 50%) of the energy delivery member 155 and the passage 156 are offset to one side of the longitudinal axis X1).

[0238] One or more energy emitters 157 are supported by the energy delivery member 155 near the outer surface (wall, circumference) 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 a plurality of energy emitters 157i, 157ii, 157iii extending along its circumference. Although Figure 12 The embodiment shown includes three energy emitters 157, but it should be understood that the number of energy emitters 157 can 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.

[0239] Expansion (e.g., inflation) of the energy delivery member 155 brings the energy emitters 157 closer to the vascular obstruction to emit energy to treat the blood clot or other vascular obstruction. The energy emitters 157 can be arranged in various arrays and spaced apart in any suitable manner (e.g., along the circumference of the energy delivery member 155). Like the other energy emitters disclosed above, the energy emitters 157 can emit ultrasonic energy or other energy, and at various frequencies. A connector 152 (e.g., one or more wires) connects the energy emitters 157 to an external energy source E, which allows energy to be applied to the energy delivery member 155 by transferring energy from the external energy source E to the energy emitters 157. In the illustrated embodiment, the connector 152 extends within (through) the catheter body 142 (e.g., via the lumen 143). However, it is also contemplated that in various embodiments of the present disclosure, the connector 152 may extend within or substantially within the wall of the catheter, or may extend externally to the catheter body 142.

[0240] like Figure 12 , the energy emitters 157 can be positioned on the outer surface 159A of the body 159 of the energy delivery member 155. Alternatively, it is contemplated that the energy emitters 157 can extend from within the energy delivery member 155 onto the outer surface 159A, or that the energy emitters 157 can be located within the energy delivery member 155. For example, the energy emitters 157 can be embedded within the material used in the construction of the energy delivery member 155 such that they are positioned radially inward of the outer surface 159A. In such embodiments, the energy emitters 157 can be exposed via one or more openings (e.g., windows) formed in the outer surface 159A of the body 159.

[0241] In use, the energy delivery member 155 is introduced across the target tissue (e.g., a valve or other such target site) and expanded (e.g., inflated). While expanded (e.g., to fill the lumen of a vessel), blood flow is maintained through the passage 156 extending through the energy delivery member 155. Energy from an energy source E is then applied to the energy emitter 157 for a period of time to treat the target tissue. After treatment, energy transmission to the energy emitter 157 is stopped, and the energy delivery member 155 is collapsed (e.g., deflated), which allows the catheter 140 to be removed. In some embodiments, these steps of balloon inflation and energy delivery can be repeated two or more times before the catheter is removed.

[0242] In some embodiments, the energy delivery member 155 is expanded (e.g., inflated) so that the energy emitter 157 contacts the target tissue (e.g., an obstruction or calcification in the lumen of a blood vessel). In other embodiments, the energy delivery member 155 can be configured such that the energy emitter 157 is spaced apart from (not in contact with) the target tissue after expansion (e.g., inflating).

[0243] In some embodiments, as Figure 12 As shown, the catheter body 142 can define a single lumen 141 to allow for passage of a wire therethrough, injection of a fluid into a target site, expansion and collapse (e.g., inflation and deflation) of an energy delivery member 155, etc. In other embodiments, the catheter body 142 can include a separate, dedicated lumen configured to support expansion and collapse (e.g., inflation and deflation) of the energy delivery member 155, which can extend through (and within) the outer wall of the catheter body 142. It is also contemplated that the catheter body 142 can include a plurality of energy delivery members 155, each of which can be fed through a separate lumen, as discussed in further detail below.

[0244] As with the catheters described above, catheter 140 may have a filter at the distal end.

[0245] Due to the presence of passageway 156, energy delivery member 155 is able to expand (e.g., inflate) for a long time within a heart valve, blood vessel, or other area without significantly blocking outflow / blood flow. Without passageway 156, blood flow would be blocked (or completely obstructed), which could lead to adverse consequences if interrupted for a long time, particularly during surgery (such as heart valve surgery). The bypass catheter disclosed herein (e.g., a bypass catheter having a balloon mounted or carrying an energy emitter) is also able to expand (e.g., inflate) for a long time within a valve (such as a heart valve, for example), blood vessel, or other area without significantly blocking outflow / blood flow as blood flows into the side holes and out of the distal holes. It is contemplated that the catheter disclosed herein can be used for intravascular or intraluminal lithotripsy to break down calcium (e.g., via the aforementioned energy emitter 157 mounted or carried by energy delivery member 155) while providing a channel / passageway for blood flow (e.g., via passageway 156). For example, the catheter described herein can be used preoperatively to soften any such calcium deposits.

[0246] Although blood is allowed to flow through the energy delivery member 155 via the passage 156 during the procedure, blood flow may still be restricted (e.g., due to backflow (retrograde blood flow) from the aorta into the left ventricle). To address this issue, in an alternative embodiment, the catheter 140 may include an energy delivery member 155A ( Figure 12A ), the energy delivery member has a body 159A that defines a passageway 156A that includes (supports) a valve 151A to inhibit (if not entirely prevent) retrograde blood flow (e.g., backflow) through the energy delivery member 155A (e.g., thereby extending the time available to complete a lithotripsy or other such surgical procedure). In the illustrated embodiment, the valve 151A includes a tricuspid valve structure having leaflets 151Ai, 151Aii, 151Aiii. However, it should be understood that, as explained below, the configuration of the valve 151A may vary in alternative embodiments without departing from the scope of the present disclosure.

[0247] Valve 151A (other valves disclosed herein) can open and close, and in some embodiments can be intermittently open. The open valve allows blood to flow through the valve. In some embodiments, the pressure gradient across the valve causes the valve to open.

[0248] The valves disclosed herein can be used to inhibit blood flow during diastole, allowing for longer periods of treatment without symptomatic cardiac blood flow (because blood flow cannot be stopped during systole or the patient will die).

[0249] Figure 12BAnother embodiment of the present disclosure is shown in which a catheter 140 includes an energy delivery member 155B having an annular (or generally annular, toroidal configuration) shape that defines an outer surface 158B having a continuous curvature. Although the energy delivery member 155B is shown as including a passageway 156B and a valve 151B having a circular (or generally circular) transverse cross-sectional configuration (e.g., diameter), it should be understood that the specific configurations of the passageway 156B and the valve 151B may vary in alternative embodiments without departing from the scope of the present disclosure. For example, Figure 12C An alternative embodiment of an energy delivery member 155B is shown, identified generally by reference numeral 155C, including a passageway 156C and a valve 151C having a non-circular (eg, elliptical) transverse cross-sectional configuration.

[0250] Conceptually, when a valve is stenotic, the outer parts of the leaflets fuse together and the remaining hole narrows. When TAVR (transcatheter aortic valve replacement) is performed, a balloon or self-expanding valve is used to hold the stenotic valve open. But if the fused portion of the valve is highly calcified, the valve and adjacent tissue and / or the aortic root can rupture when stretched, which is often fatal. The catheter of the present invention can be used to soften the calcium via lithotripsy prior to TAVR, thereby preventing this catastrophic complication. If the balloon (or other such expandable member) is only in a small hole, the contact area for lithotripsy is very limited. Conversely, if the surface area can be increased, the calcification can be reduced, Figures 14 and 15 The catheters achieve this by providing an increased surface area for lithotripsy. These catheters have energy emitters mounted on balloon portions that are placed on opposite sides of the valve.

[0251] More specifically, Figure 15 A catheter 170 is shown comprising a catheter body 172 and an energy delivery member 175 mounted on (or otherwise secured to) the catheter body 172 such that the energy delivery member 175 extends radially outward from the catheter body. In the illustrated embodiment, the energy delivery member 175 is configured as an expandable member (e.g., a balloon) 175A having a (generally) cylindrical configuration defining a channel 176 that is configured to receive the catheter body 172 such that the catheter body 142 extends therethrough as shown. An area of ​​the catheter 170 distal to the energy delivery member 175 is designated by reference numeral 171, and an area of ​​the catheter 170 proximal to the energy delivery member 175 is designated by reference numeral 173. It should be understood that the energy delivery member 175 can be located 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. The port 180 is used to inject a fluid (liquid or gas) to expand (eg, inflate) the energy delivery member 175 .

[0252] The energy delivery member 175 includes a passageway 178 (e.g., an opening, channel, conduit, etc.) that extends in parallel (or substantially parallel) relation to the longitudinal axis X2 defined by the catheter body 172 to allow blood (e.g., after expansion) to flow through the energy delivery member 175 during a surgical procedure. In the particular embodiment shown, the passageway 178 is defined by a tubular member (portion, cannula) 183 having proximal and distal openings extending through the energy delivery member 175. The tubular member 183 and the passageway 178 are positioned eccentrically and radially offset from the center of the channel 176 and the energy delivery member 175, such that a majority (e.g., greater than 50%) of the tubular member 183 is offset to one side of the longitudinal axis X2 defined by the catheter body 172.

[0253] In certain embodiments, as Figure 15A As shown, the catheter 170 may include a valve 179 located within the passage 178 (e.g., within the tubular member 183). The valve 179 is similar to the valve 179 described above with respect to Figure 12A The valve 151 discussed is similar (if not identical) and is configured to inhibit (if not completely prevent) blood flow through the energy delivery member 175. For example, Figure 15A As shown, the valve 179 can be configured to inhibit, if not completely prevent, retrograde blood flow (e.g., backflow) (e.g., in the proximal direction indicated by arrow 1) through the energy delivery member 175. However, it is also contemplated that the configuration of the valve 179 can be reversed (inverted) such that the valve 179 is configured to inhibit, if not completely prevent, antegrade blood flow (e.g., in the distal direction indicated by arrow 2) through the energy delivery member 175.

[0254] Upon expansion (e.g., inflation), the energy delivery member 175 defines (includes): a first (distal) portion 182; a second (proximal) portion 184; and a middle portion 186 located between the first portion 182 and the second portion 184. The middle portion 186 forms a waist or narrow portion with a gap 188 that is configured to receive target tissue (e.g., a patient's valve) upon expansion (e.g., inflation) of the energy delivery member 175. That is, the transverse dimension of the middle (narrow) portion 186 is smaller than the transverse dimensions of the first portion 182 and the second portion 184. In this manner, the respective first and second portions 182, 184 can be placed on opposite sides of the target tissue, with at least one energy emitting surface configured to press against opposite sides of the target tissue (e.g., for treating a valve, such as a heart valve), and configured for placement on different sides of the waist, as described below.

[0255] As above combined Figure 12As described with reference to the catheter 140 shown in FIG, one or more energy emitters 187 are supported by the energy delivery member 175 near its outer surface, these energy emitters being configured to deliver energy to the target tissue to facilitate treatment thereof. For example, in the particular embodiment shown, the energy delivery member 175 includes a plurality of energy emitters 187 extending along its circumference. More specifically, the energy delivery member 175 includes energy emitters 187 supported (located, positioned) on the second portion 182 to face the first portion 184, and energy emitters 187 supported (located, positioned) on the first portion 184 to face the second portion 182. It is contemplated that one or more energy emitters 187 may be provided on each of the respective first portion 182 and the second portion 184 (in any suitable location).

[0256] Expansion (e.g., inflation) of the energy delivery member 175 brings the energy emitter 187 closer to the target tissue to facilitate delivery of energy to the target tissue during treatment (e.g., to reduce calcium). Like the other energy emitters disclosed above, the energy emitter 177 can emit ultrasonic energy or other energy, and at various frequencies.

[0257] A connector 189 (e.g., one or more wires) connects the energy emitter 187 to an external energy source F. The energy emitter 187 can be positioned on the outer wall (circumference) of the energy delivery member 175. Alternatively, the energy emitter 187 can extend from within the energy delivery member 175 onto the outer wall, or the energy emitter 187 can be located within the energy delivery member 175. For example, the energy emitter 187 can be embedded within the material used in the construction of the energy delivery member 175. In such embodiments, the energy emitter 187 can be exposed via one or more openings (e.g., windows) defined through the energy delivery member 175.

[0258] It is contemplated that in various embodiments of the present disclosure, the energy emitters 187 may be arranged in various arrays and spaced apart in various manners to achieve any necessary or desired therapeutic effect (e.g., depending on the specific nature and / or specific location of the abnormality being treated). Figure 15 In a specific embodiment, for example, the energy emitter 187 extends from the connector 189 to define a (forked) first branch 187A having (first and second) legs 187i, 187ii and a (forked) second branch 187B having (third and fourth) legs 187iii, 187iv, wherein the legs 187i, 187iii are disposed on the first portion 182 of the energy delivery member 175 and the legs 187ii, 187iv are disposed on the second portion 184 of the energy delivery member 175. Figure 15As shown, legs 187i, 187ii extend in a first (circumferential) direction, while legs 187iii, 187iv extend in an opposite second (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.

[0259] In some embodiments, the energy delivery member 175 is expanded (e.g., inflated) so 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 is spaced apart from (not in contact with) the target tissue after expansion (e.g., inflating).

[0260] In use, the energy delivery member 175 is introduced across the target tissue (e.g., a valve or other such target site) and the energy delivery member 175 is expanded (e.g., inflated). After expansion, the energy delivery member 175 is positioned so that the second portion 182 is located near (e.g., in contact with) a first (distal) side of the target tissue and the first portion 184 is located near (e.g., in contact with) a second (e.g., proximal) side of the target tissue, such that the energy delivery member 175 spans (across) the target tissue, whereby the waist formed by the middle portion 186 receives the target tissue (e.g., such that the valve orifice and / or leaflets are located within the gap 188). In some embodiments, the energy delivery member 175 can be configured so that the respective first and second portions 182, 184 can be spaced (e.g., axially) from the target tissue (e.g., sides of the valve and / or leaflets). Alternatively, the energy delivery member 175 can be configured such that the respective first and second portions 182, 184 can contact the target tissue (e.g., the sides of the valve and / or leaflets). For example, the energy delivery member 175 can be configured such that the respective first and second portions 182, 184 form abutment sides that press against the opposite sides of the valve (e.g., the leaflets).

[0261] During use of the catheter 170, as the energy delivery member 175 is expanded (e.g., inflated), energy is applied to the target tissue via the energy emitter 187 over a period of time. 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 case of a calcified valve, the increased surface area contacted by the energy delivery member 175 significantly reduces the load of brittle calcium in the valve and surrounding tissue. When expanded (e.g., inflated), although the energy delivery member 175 can fill the vessel lumen, blood flow is maintained through the passage 178 in the energy delivery member 175.

[0262] After treatment, energy delivery to energy emitter 187 is stopped, and energy delivery member 175 is collapsed (eg, deflated), which allows removal of catheter 170. In some embodiments, these steps of emitting energy and inflating can be repeated two or more times.

[0263] Now refer to Figure 14 , another embodiment of a catheter will be discussed, which is identified by reference numeral 190. Catheter 190 includes a catheter body 191 having an energy delivery member 195 and a (main, working) lumen 193 extending therethrough that is configured to receive one or more ancillary medical devices (e.g., catheters, instruments, tools, etc.).

[0264] The energy delivery member 195 is supported by the catheter body 191 (mounted on or otherwise secured to the catheter body) such that the energy delivery member 195 extends radially outward from the catheter body and is substantially similar to the previously described energy delivery member 175 ( Figure 15 ). More specifically, upon expansion (e.g., inflation), energy delivery member 195 defines a cylindrical (or substantially cylindrical) configuration and includes: a first (distal) portion 192 defining a (distal) end surface 192A that is configured as a planar (or substantially planar); a second (proximal) portion 194 defining a (proximal) end surface 194A that is configured as a planar (or substantially planar); and an intermediate portion 196 located between first portion 192 and second portion 194. However, it should be understood that alternative configurations of energy delivery member 195 are also contemplated herein, as described in further detail below.

[0265] The middle portion 196 forms a waist or narrow portion with a gap 198 that is configured to receive the target tissue (e.g., a patient's valve). That is, the transverse dimension of the middle (narrow) portion is smaller than the transverse dimensions of the first portion 192 and the second portion 194. In this way, the first portion 192 and the second portion 194 can be placed on opposite sides of the target tissue (e.g., a valve leaflet) in the same manner as the energy delivery member 175.

[0266] exist Figure 14 In the particular embodiment shown, the energy delivery member 195 is centrally located (concentrically mounted) relative to the longitudinal axis X3 defined by the body 193 of the catheter 190. However, it is also contemplated that the energy delivery member 195 may be eccentrically located (e.g., such that the center of the energy delivery member 195 is radially offset from the longitudinal axis X3). Compared to the catheter 170, the catheter 190 is configured and functions similarly to a bypass catheter (similar to a Figure 1The catheter shown in FIG. 1 is a schematic diagram of a catheter body 191, wherein the energy delivery member 195 has no blood flow passages (e.g., passages 178 discussed above). Instead, the catheter body 191 includes side holes 199a and distal end holes 199b (which can be connected to the aforementioned side holes 2 and end holes 4, respectively). Figure 1 ), which promotes blood flow into the side hole 199a, through the catheter body 191, and out the distal end hole 199b in the same manner as the bypass catheter described herein.

[0267] Energy delivery member 195 includes an energy emitter 197, which is similar to that described above with respect to catheter 170 ( Figure 15 ) and is in communication with an external energy source F via a connector 197a. The energy emitter 197 is configured and positioned to direct energy into the gap 198 upon receipt of the target tissue to facilitate treatment thereof. More specifically, the energy delivery member 195 includes energy emitters 197i, 197ii supported on the second portion 194 to face the first portion 192 and energy emitters 197iii, 197iv supported on the first portion 192 to face the second portion 194, whereby the energy emitters 197i, 197ii and the energy emitters 197iii, 197iv face opposite (or substantially opposite) directions.

[0268] Regarding placement with respect to target tissue (eg, a heart valve), catheter 190 and energy delivery member 195 are positioned relative to catheter 170 ( Figure 15 ) and energy delivery member 175. However, compared to catheter 170, during use of catheter 190, blood flows through side holes 199a to distal holes 199b (via catheter body 191) rather than through energy delivery member 195 itself, which also reduces (if not completely eliminates) severe flow obstruction after expansion (e.g., inflation) of energy delivery member 195. Energy emitters 197iii, 194iv (e.g., 14A to 16A energy emitters) are on the proximal-facing surface of the distal portion 192, opposite the distal-facing surface 192A, and energy emitters 197i, 197ii (such as Figures 14 to 16A energy emitter) on the distal-facing surface of the proximal portion 194, opposite the proximal-facing surface 194A.

[0269] Figure 14A An alternative embodiment of a (bypass) catheter 190 is shown that includes a valve 185 located (positioned, supported) within a lumen 193 defined by a catheter body 191 (e.g., to sealingly receive an ancillary medical device M and / or inhibit blood flow through the catheter 190). In all other respects, Figure 14A The catheter and Figure 14Although shown as being located near (or substantially near) the energy delivery member 195 (e.g., such that the energy delivery member 195 spans the valve 185), it should be understood that the specific location of the valve 185 may vary in various embodiments without departing from the scope of the present disclosure. For example, as discussed in further detail below, embodiments are also contemplated herein in which the valve 185 may be located proximal or distal to the energy delivery member 195.

[0270] Figure 14B Another embodiment of a (bypass) catheter 190 is shown in which an energy delivery member 195 includes a passageway 181 and the aforementioned valve 179. To accommodate the passageway 181, the gap 198 defined by the intermediate portion 196 of the energy delivery member 195 is shortened and defines a reduced radial dimension (length) (e.g., when compared to the valve 179). Figure 14 and Figure 14A 190 embodiment shown).

[0271] The valve 179 is located (positioned, supported) within the passageway 181 and is configured to inhibit, if not completely prevent, the flow of blood through the passageway 181 and through the energy delivery member 195. Figure 14B In the particular embodiment of the present disclosure shown, the valve 179 is configured to inhibit, if not completely prevent, retrograde blood flow (e.g., backflow) (e.g., in the proximal direction indicated by arrow 1) through the energy delivery member 195. However, as Figure 14C As shown, it is also contemplated that the configuration of the valve 179 can be reversed (inverted) such that the valve 179 is configured to inhibit, if not entirely prevent, antegrade blood flow (e.g., in the distal direction indicated by arrow 2) through the energy delivery member 195.

[0272] exist Figure 14B In the particular embodiment of the present disclosure shown, the energy delivery member 195 is mounted eccentrically, whereby the energy delivery member 195 and the passageway 181 are each radially offset from (not aligned with) 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 passageway 181 are positioned eccentrically relative to and offset to one side of the longitudinal axis X3). However, embodiments are also contemplated in which the energy delivery member 195 can be positioned concentrically about the catheter body 191 while the passageway 181 remains radially offset from the longitudinal axis X3.

[0273] refer to Figure 14DDuring use, the catheter 190 is advanced through an access vessel A (e.g., a patient's aorta) via a femoral or radial artery approach toward a target tissue (e.g., a patient's heart valve C) until the distal portion 192 of the energy delivery member 195 is positioned distal to the target tissue and the proximal portion 194 of the delivery member 195 is positioned proximal to the target tissue. When so positioned, the target tissue (e.g., leaflets Li, Lii of the heart valve C) is received in a gap 198 ( Figure 14B ) so that the energy emitter 197 is positioned near (or approximately near) the target tissue (e.g., so that the energy emitter 197 is in contact therewith). Energy is then transmitted from the external energy source F to the target tissue via the connector 197a and the energy emitter 197, thereby treating the target tissue (e.g., softening any calcium deposits on the leaflets Li, Lii).

[0274] When the catheter 190 Figure 14D When positioned in the manner shown, its distal region 191a spans (extends across, distally beyond) the target tissue, which allows blood to bypass the target tissue through the distal region 191a (depending on the direction of blood flow). For example, it is contemplated that blood can flow through the side hole 199a, through the distal region 191a, and out of the distal end hole 199b, or blood can flow through the distal end hole 199b, through the distal region 191a, and out of the side hole 199a. The catheter 190 can be configured so that its proximal end is positioned outside the patient (e.g., to allow aspiration of debris, clotted material, etc. through the proximal end), whereby the proximal region 191b of the catheter 190 is not used for bypass surgery. It should be noted that the side hole 199a (and other side holes for blood flow in other catheters disclosed herein) can be positioned in the catheter in addition to Figure 14D Parts other than those shown.

[0275] In some methods of use, if side hole 199a is covered (e.g., by access vessel A or other portion of the patient's tissue), the shunt will be closed and blood will not flow through catheter 190. However, to establish blood flow, blood may flow back or be actively aspirated out of the body (e.g., via the proximal end of catheter 190).

[0276] Figure 14E Another embodiment of a (bypass) catheter 190 is shown in which the energy delivery member 195 includes a valve 179A. Figure 14B and Figure 14C Compared to the valve 179 shown, the valve includes the same Figure 12AWhile valve 151 of interest is similar, if not identical, to a tricuspid configuration defining leaflets 179i, 179ii, 179iii, valve 179A includes a bicuspid configuration defining leaflets 179Ai and 179Aii.

[0277] Figure 16 Another embodiment of a (bypass) catheter of the present disclosure is shown and is identified by reference numeral 200. The catheter 200 includes a catheter body 202 defining a longitudinal axis X4 and a (main, working) lumen 203 configured to receive one or more auxiliary 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 Siamese configuration to define a space (gap) 208 therebetween, and are each centrally located about (concentrically mounted to) the catheter body 202.

[0278] During use of the catheter 200, the distal energy delivery member 205 is placed on one side of the target tissue (e.g., a leaflet), and the proximal energy delivery member 207 is placed on the other side of the target tissue. Figure 15 As described above, the gap (gap) 208 is formed by the axial spacing of the energy delivery members 205 and 207 rather than by a narrow portion. The energy delivery members 205 and 207 each include one or more energy emitters 211, which are connected to an external energy source F via a connector 213. The energy emitters 211 are arranged in a relative relationship such that the energy emitters 211 included on the energy delivery member 205 are oriented toward (facing) the energy delivery member 207, and the energy emitters 211 included on the energy delivery member 207 are oriented toward (facing) the energy delivery member 205. With respect to the placement of the energy delivery members 205 and 207 (one on each side of the valve) and the flow of blood through the catheter 200, the catheter 200 operates in the same manner as the previously described catheter 190. More specifically, blood flows through the side holes 206, through the lumen 203 defined by the catheter body 202, and through the distal end hole 209.

[0279] As described above with respect to the catheter 170 ( Figure 15 ), it is contemplated that the energy emitters 211 may be arranged in various arrays and spaced apart in various ways to achieve any necessary or desired therapeutic effect (e.g., depending on the specific nature and / or specific location of the abnormality being treated). For example, in Figure 16In the particular embodiment of the present disclosure shown, the energy emitter 211 extends from the connector 213 to define a (continuous, non-bifurcated) first (distal) branch 211A extending circumferentially around (partially or fully) the energy delivery member 205 and a (continuous, non-bifurcated) second (proximal) branch 211B extending circumferentially around (partially or fully) the energy delivery member 207.

[0280] It should be noted that, as discussed above, shapes other than those discussed in connection with the energy delivery members described above may also be used to treat target tissue (eg, a valve).

[0281] It is contemplated that the energy delivery members 175, 195, 205, etc. may alternatively have a figure eight configuration.

[0282] It should be noted that Figures 15 and 16 The catheter in is described as being used with valves (such as heart valves), but can be used to treat other areas / tissues in a patient while maintaining blood flow.

[0283] In some embodiments of the devices disclosed herein, blood may flow through the device in the reverse direction when the device is introduced from a retrograde "upstream" approach. This is depicted in, for example, Figure 13 , wherein blood flows through the distal opening 167 of the catheter in the direction of the arrow and may flow out of the side hole 162 and / or the proximal hole 163. As in the previous embodiments, the catheter 160 may include an energy delivery member 166 (e.g., a balloon or other such expandable structure) having an energy emitter connected to an external energy source E via a wire 164. As in the previous embodiments, the catheter 160 may also include a filter 168 proximal or distal to the energy emitter.

[0284] Figure 16A Another embodiment of a (bypass) catheter 200 is shown in which a distal energy delivery member 205 and a proximal energy delivery member 207 are configured as separate (discrete) structures that are axially spaced from one another along the longitudinal axis X4 defined by the catheter body 202 to define a spacing (gap) 208. The energy delivery members 205, 207 define (first and second) passageways 215, 217, respectively, which are aligned with the aforementioned passageway 156 ( Figure 12 、 Figure 12A )、181( Figure 14B ) are similar (if not identical).

[0285] exist Figure 16AIn a particular embodiment, the energy delivery members 205, 207 are mounted eccentrically, whereby the energy delivery members 205, 207 and the passageways 215, 217 are each radially offset from (not aligned with) the longitudinal axis X4 defined by the catheter body 202 (e.g., such that a majority (greater 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 can be concentrically positioned about the catheter body 202, while the passageways 215, 217 remain radially offset from the longitudinal axis X3.

[0286] like Figure 16A As shown, the energy delivery members 205, 207 are configured such that the passageways 215, 217 are oriented (substantially) in radial alignment, which promotes 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 permit antegrade blood flow therethrough (e.g., in the distal direction indicated by arrow 2), while retrograde blood flow (e.g., backflow in the proximal direction indicated by arrow 1) is inhibited (if not completely prevented) by a valve 219 located within the passageway 217 extending through the energy delivery member 207 and which is in contact with the valve 151 ( Figure 12A )、179( Figure 14B 、 Figure 14C ) are similar (if not identical). In alternative embodiments of the present disclosure, the configuration of the valve 219 can be reversed (inverted) such that the valve 219 is configured to inhibit, if not entirely prevent, antegrade blood flow through the energy delivery members 205, 207 (e.g., in the distal direction indicated by arrow 2), and / or the valve 219 can be located within the passageway 215 extending through the energy delivery member 205.

[0287] Figure 17 Another embodiment of a (bypass) catheter is shown, which is identified by reference numeral 300. The catheter 300 is similar to the catheter 190 ( Figure 14 ) are substantially similar, and therefore, for the sake of brevity, we will only discuss their differences. As such, the same reference numerals will be used to refer to elements, structures, features, etc. that are common to catheters 190, 300.

[0288] Compared to catheter 190, catheter 300 includes an energy delivery member 302 having an annular (or substantially annular, toroidal) shape that defines an outer surface 304 having a continuous curvature. Energy delivery member 302 includes (defines) a channel 306 that is configured to receive catheter body 191 such that catheter body 191 extends therethrough. In the particular embodiment shown, energy delivery member 302 is centrally positioned about catheter body 191 (concentrically mounted thereto). However, it is also contemplated that energy delivery member 302 may be positioned eccentrically (e.g., such that channel 306 is radially offset from longitudinal axis X3 defined by catheter body 191).

[0289] In the illustrated embodiment, the energy delivery member 302 includes a single energy emitter 197 that is positioned on (or near) the outer surface 304 of the delivery member 302. However, it should be understood that the number of energy emitters 197 included on the energy delivery member 302 may vary in alternative embodiments without departing from the scope of the present disclosure. Figure 17 302, it will be appreciated that the specific configuration of the energy emitter 197 may vary in alternative embodiments without departing from the scope of the present disclosure. For example, embodiments are also contemplated in which the energy emitter 197 only partially surrounds the energy delivery member 302.

[0290] Figure 18 Another embodiment of a (bypass) catheter is shown, which is identified by reference numeral 400. The catheter 400 is similar to the catheter 190 ( Figure 14 )、300( Figure 17 ) are substantially similar, and therefore, for the sake of brevity, we will only discuss any differences therebetween. As such, the same reference numerals will be used to refer to elements, structures, features, etc. that are common to the catheters 190, 300, 400.

[0291] The catheter 400 includes a pair of energy delivery members 402, 404 oriented in adjacent (eg, side-by-side, stacked) relationship to define a lemniscate (or substantially lemniscate) configuration. Figure 18 While shown connected together in the particular embodiment illustrated, it will be appreciated that the energy delivery members 402, 404 may be configured as separate (discrete) structures in alternative embodiments without departing from the scope of the present disclosure.

[0292] Each of the energy delivery members 402, 404 includes a Figure 17) are annular (or substantially annular, toroidal) structures similar (if not identical) to those discussed above. More specifically, the energy delivery members 402, 404 include bodies 406, 408 defining outer surfaces 410, 412, respectively, and including passageways 414, 416 extending therethrough in a parallel (or substantially parallel) relationship to the longitudinal axis X3 defined by the catheter body 191. In certain embodiments, such as Figure 18 As shown in FIG, energy delivery members 402, 404 may include valves 418, 420 located within passages 414, 416, respectively, which are similar to valves 151 ( Figure 12A )、151B( Figure 12B )、179( Figure 14B The valves 418, 420 may be configured to inhibit, if not completely prevent, retrograde blood flow (e.g., backflow) (e.g., in the proximal direction indicated by arrow 1) through the respective energy delivery members 402, 404, or the configuration of the valves 418, 420 may be reversed (inverted) such that the valves 418, 420 are configured to inhibit, if not completely prevent, antegrade blood flow (e.g., in the distal direction indicated by arrow 2) through the energy delivery members 402, 404.

[0293] like Figure 18 As shown, each of the energy delivery members 402, 404 is supported eccentrically by the catheter body 191 (e.g., such that the passageways 414, 416 and valves 418, 420 are radially offset from the longitudinal axis X3). To facilitate connection (installation) to the catheter body 191, the energy delivery members 402, 404 collectively define a channel 422 that is configured to receive the catheter body 191 such that the catheter body 191 extends therethrough.

[0294] In the illustrated embodiment, the catheter 400 includes a single energy emitter 197 positioned on (or adjacent) the respective outer surfaces 410, 412 of the bodies 406, 408 of the energy delivery members 402, 404. However, it should be understood that the number of energy emitters 197 may vary in alternative embodiments without departing from the scope of the present disclosure. For example, each energy delivery member 402, 404 may support (include) a separate (discrete) energy emitter 197. Additionally, while Figure 18 412, it should be understood that the specific configuration of the energy emitter 197 may also be different in alternative embodiments. For example, embodiments in which the energy emitter 197 only partially surrounds the outer surfaces 410, 412 are also contemplated herein.

[0295] Now refer to Figure 19, another embodiment of a (bypass) catheter will be discussed, which is identified by reference numeral 500. Catheter 500 includes an energy delivery member 502 and is coupled to catheter 190 ( Figure 14 )、300( Figure 17 )、400( Figure 18 ) are substantially similar, but differ in the configuration of energy delivery member 502. Therefore, for the sake of brevity, catheter 500 will be discussed herein only with respect to the differences between catheters 190, 300, 400, and the same reference numerals will be used to refer to elements, structures, features, etc., that are common to catheters 190, 300, 400, 500.

[0296] The energy delivery member 502 is supported by (e.g., mounted on or otherwise secured to) the catheter body 191 such that the energy delivery member 502 extends radially outward from the catheter body. Figure 12 、 Figure 12A ), energy delivery member 195 ( Figures 14 to 14E ), energy delivery member 175 ( Figures 15 to 15A ), the energy delivery member 502 is non-expandable, which allows the configuration of the catheter 500 to be simplified by omitting any need for an inflation lumen, thereby allowing the overall size and / or cost of the catheter body 191 to be reduced. Although the catheter 500 is shown as including a single energy delivery member 502, it should be understood that, as discussed in further detail below, in alternative embodiments of the present disclosure, the number of energy delivery members 502 can be increased. For example, it is contemplated that the catheter 500 can include two energy delivery members 502, three energy delivery members 502, etc. Additionally, although in Figure 19 In the particular embodiment shown, the energy delivery member 502 is shown as being fixedly supported on (connected to) the catheter body 191, but as discussed in further detail below, in alternative embodiments, the energy delivery member 502 can be movably (e.g., slidably) supported on (connected to) the catheter body 191.

[0297] The energy delivery member 502 comprises a deformable (e.g., flexible) material that allows the energy delivery member 502 to resiliently reconfigure (e.g., bend, compress, etc.) during insertion and removal of the catheter 500. More specifically, the energy delivery member 502 comprises a disc-shaped configuration defining an annular (or substantially annular) transverse cross-sectional configuration (e.g., diameter) and corresponding proximal and distal end faces 504, 506. Although Figure 19While shown as circular (or substantially circular) in the particular embodiment shown, it should be understood 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 transverse cross-sectional configuration that is elliptical (or substantially elliptical), lemniscate (or substantially lemniscate), etc. Additionally, while Figure 19 In the illustrated embodiment of the present disclosure, the end faces 504, 506 of the energy delivery member 502 are illustrated as being planar (or substantially planar), but it should be understood that the specific configuration of the end faces 504, 506 may vary in alternative embodiments of the present disclosure. For example, embodiments are also contemplated herein in which one or both of the end faces 504, 506 may include an arcuate (e.g., concave or convex) configuration.

[0298] In the particular embodiment shown, the energy delivery member 502 is centrally positioned (concentrically mounted) relative to the longitudinal axis X3 defined by the catheter body 191. More specifically, the energy delivery member 502 includes a passageway 508 that is configured to receive the catheter body 191 such that the catheter body 191 extends (in both the proximal and distal directions) through the energy delivery member 502. However, as described in further detail below, it is also contemplated that the energy delivery member 502 can be positioned eccentrically (e.g., such that the center of the energy delivery member 502 is radially offset from the longitudinal axis X3).

[0299] The energy delivery member 502 includes (or supports) one or more energy emitters 197 that communicate with an external energy source F via a connector 197a and are similar or identical to the previously described energy emitters 157, 187, 197, etc. The energy emitters 197 are supported by the energy delivery member 502 such that they are positioned on (or near) the end face 504 and / or the end face 506 and extend around (or around) the passageway 508 in a nonlinear (e.g., zigzag) configuration. For example, in the illustrated embodiment, the energy emitters 197 are positioned on (or near) the outer surfaces of the end faces 504, 506 and point in opposite (or substantially opposite) directions. However, as discussed in conjunction with the previous embodiments of the present disclosure, it is contemplated that the energy emitters 197 can be arranged in various arrays and spaced apart in any manner suitable for the desired purpose of delivering energy to the target tissue to facilitate treatment as described herein. For example, the energy emitters 197 can extend partially or entirely around the perimeter 510 (e.g., the circumference or outermost radial surface) of the energy delivery member 502 (e.g., depending on the specific knot configuration, location, etc. of the target tissue being treated), and / or the energy emitters 197 can extend from within the energy delivery member 502 onto the end faces 504, 506 (e.g., in a linear or substantially linear configuration). The energy emitters 197 can alternatively be located internally (within) the energy delivery member 502 (e.g., the energy emitters 197 can be embedded within the material used to construct the energy delivery member 502 such that the energy emitters 197 are positioned radially inwardly of the end faces 504, 506). In such embodiments, the energy emitters 197 can be exposed via one or more openings (e.g., windows) formed in the end faces 504, 506. In alternative embodiments, the energy emitters can be positioned on only one of the end faces 504, 506.

[0300] Figure 19A Another embodiment of a (bypass) catheter is shown, which is identified by reference numeral 500A. Catheter 500A includes an energy delivery member 502A and is coupled to catheter 500 ( Figure 19 ) are substantially similar, but the energy delivery member 502A is different, and therefore, for the sake of brevity, we will only discuss any differences therebetween. As such, the same reference numerals will be used to refer to elements, structures, features, etc. that are common to catheters 500 and 500A.

[0301] Energy delivery member 502A defines respective proximal and distal end faces 504A, 506A, and includes a passageway 508A and a valve 509A. Valve 509A is similar to valve 151 ( Figure 12 、 Figure 12A )、179( Figure 15) is similar (if not identical) to and is located (supported) within passageway 508A such that catheter body 191 can extend (in both the proximal and distal directions) therethrough. Figure 19A 8A and the valve 509A are shown as being centrally positioned in the specific embodiment seen in FIG, but it is also contemplated that the passage 508A and the valve 509A can be eccentrically positioned (e.g., such that the passage 508A and the 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), as further described in detail below.

[0302] Compared to the energy delivery member 502 in the catheter 500, in which the passageway 508 defines a transverse cross-sectional dimension (e.g., diameter) that is substantially similar to the dimension defined by the catheter body 191, the passageway 508A through the energy delivery member 502A defines a transverse cross-sectional dimension (e.g., diameter) D0 that substantially exceeds the dimension defined by the catheter body 191, which dimension is indicated by the reference numeral D. For example, it is contemplated that the transverse cross-sectional dimension D0 can be substantially within a range of approximately 125% to approximately 500% of the transverse cross-sectional dimension D.

[0303] The energy delivery member 502A includes (supports) one or more of the aforementioned energy emitters 197, which in the illustrated embodiment are positioned on (near) the end faces 504A, 506A and extend concentrically around (around) the passageway 508A. Figure 19A The specific embodiment shown is shown as including a single energy emitter 197 on each of the end surfaces 504A, 506A, but it is contemplated that the number of energy emitters 197 may be increased or decreased in alternative embodiments. For example, embodiments are also contemplated herein that include one or more energy emitters 197 only on the end surface 506A or only on the end surface 504a, as well as embodiments that include two or more energy emitters 197 on each of the end surfaces 504A, 504B, and embodiments that may not have any energy emitters 197 on either of the end surfaces 504A, 504B. As discussed in conjunction with the previous embodiments, the energy emitters 197 may be arranged in various arrays and spaced apart in any manner suitable for the desired purpose of delivering 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 along the perimeter 510A (e.g., the circumference or outermost radial surface) of the energy delivery member 502A.

[0304] In some embodiments, such as Figure 19A In the embodiment shown in FIG, the catheter 500A may include one or more stents 512 (eg, struts 514) configured to support and / or stabilize the energy delivery member 502A. Figure 19A, the catheter 500A includes a pair of (first) proximal struts 514ia, 514ib and a pair of (second) distal struts 514iia, 514iib that extend between the catheter body 191 and the energy delivery member 502A (e.g., fixed to or otherwise connected to the catheter body and the energy delivery member). However, it should be understood that the specific number and / or configuration of the struts 514 can vary in various embodiments. For example, embodiments comprising a single proximal strut 514i and a single distal strut 514ii, as well as embodiments comprising three or more proximal struts 514i and three or more distal struts 514ii are also contemplated herein. In addition, while the struts 514 are shown as being fixed (connected) to the periphery 510A of the energy delivery member 502A, alternatively or additionally, the struts 514 can be fixed (connected) to the end faces 504A, 506A.

[0305] Figure 20 Another embodiment of a (bypass) catheter 500 is shown, which is identified by reference numeral 600. The catheter 600 is similar to the catheter 500 ( Figure 19 ) are substantially similar, and therefore, for the sake of brevity, we will only discuss their differences. As such, the same reference numerals will be used to refer to elements, structures, features, etc. common to the catheters 500, 600.

[0306] Catheter 600 includes an alternative embodiment of energy delivery member 502, identified by reference numeral 602. Energy delivery member 602 is substantially similar to energy delivery member 502, but includes an aperture 612 (or other similar opening) extending therethrough. Aperture 612 includes (or otherwise supports) a valve 614 that is similar to valve 151 (described previously). Figure 12 、 Figure 12A )、179( Figure 15 ). While the aperture 612 and valve 614 are illustrated as being concentrically positioned (e.g., located at or approximately at the center of the energy delivery member 602), it will be appreciated that the aperture 612 and valve 614 may be eccentrically positioned (e.g., such that the aperture 612 and valve 614 are radially offset from the center of the energy delivery member 602) in alternative embodiments.

[0307] exist Figure 20 , wherein the energy delivery member 602 defines a (first) transverse cross-sectional dimension (e.g., diameter) D1, and the aperture 612 (and valve 614) defines a (second) transverse cross-sectional dimension (e.g., diameter) D2 that is substantially within the range of about 10% to about 30% of the transverse cross-sectional dimension D1. However, it should be understood that the ratio between the transverse cross-sectional dimensions D1 and D2 can vary in various embodiments. For example, Figure 20a shows an embodiment of a catheter 600 in which the transverse cross-sectional dimension D2 defined by the aperture 612 (and valve 614) is substantially within the range of about 40% to about 90% of the transverse cross-sectional dimension D1. (In addition, Figure 20A The device and Figure 20 same, and may optionally include side holes for blood inflow).

[0308] Reference again Figure 20 , the energy delivery member 602 is eccentrically mounted on the catheter body 191, whereby the energy delivery member 602, the aperture 612, and the valve 614 are each radially offset from (not aligned with) 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, the aperture 612, and the valve 614 are offset to one side of the longitudinal axis X3). However, embodiments are also contemplated in which the energy delivery member 602 can be concentrically positioned about the catheter body 191 while the aperture 612 and the valve 614 remain radially offset from the longitudinal axis X3.

[0309] The valve 614 can be configured to inhibit, if not completely prevent, retrograde blood flow (e.g., backflow) (e.g., in the proximal direction indicated by arrow 1) through the energy delivery member 602. However, it is also contemplated that the configuration of the valve 614 can be reversed (inverted) such that the valve 614 is configured to inhibit, if not completely prevent, antegrade blood flow (e.g., in the distal direction indicated by arrow 2) through the energy delivery member 602.

[0310] Although Figure 20 In the particular embodiment shown, the catheter 600 is shown as including a single energy delivery member 602, but it should be understood that in alternative embodiments, the number of energy delivery members 602 may be increased. Figure 20 In the particular embodiment shown, the energy delivery member 602 is shown as being fixedly supported on (connected to) the catheter body 191, but as discussed in further detail below, in alternative embodiments, the energy delivery member 602 can be movably (e.g., slidably) supported on (connected to) the catheter body 191.

[0311] Figure 21 An alternative embodiment of a (bypass) catheter 600 is shown, comprising a proximal (first) energy delivery member 602a and a second (distal) energy delivery member 602b, each of which is coupled to the energy delivery member 602 ( Figure 20) are substantially similar (if not identical). Although illustrated as including a pair of (identical or substantially identical) energy delivery members 602, it should be understood that in alternative embodiments, the number of energy delivery members 602 can 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 can differ in size, shape, flow restriction, etc. For example, embodiments are contemplated in which only one of the energy delivery members 602 (e.g., energy delivery member 602b) includes a valve 614.

[0312] The energy delivery members 602a, 602b are axially spaced apart from one another along the longitudinal axis X3 defined by the catheter body 191 to define a receiving space (chamber) 616. The receiving space 616 is configured to accommodate (receive) a target tissue (e.g., a patient's (calcified) heart valve C ( Figure 14D ), such that the energy delivery members 602a, 602b are located on opposite sides of the target tissue. The energy delivery members 602a, 602b can be configured and / or positioned along the catheter body 191 such that one or both of the energy delivery members 602a, 602b contact the target tissue during a surgical procedure (e.g., lithotripsy). When so positioned, the energy emitter 197 is positioned in adjacent (or substantially adjacent) relation to the target tissue (e.g., such that the energy emitter 197 contacts the target tissue).

[0313] exist Figure 21 In the specific embodiment shown in FIG, energy delivery member 602a includes energy emitter 197i that is oriented toward (facing) energy delivery member 602b, and energy delivery member 602b includes energy emitter 197ii that is oriented toward (facing) energy delivery member 602a, whereby energy emitters 197i and 197ii are oriented in opposite (or substantially opposite) directions. As discussed in conjunction with the previous embodiments, energy emitters 197 can be arranged in various arrays and spaced apart in any manner suitable for the desired purpose of delivering energy to target tissue to facilitate treatment as described herein.

[0314] Although Figure 21 In the illustrated embodiment, the energy delivery members 602a, 602b are shown as being fixedly supported on (connected to) the catheter body 191. In alternative embodiments, one or more energy delivery members 602a, 602b may be movably (e.g., slidably) supported on (connected to) the catheter body 191, thereby allowing the configuration of the receiving space 616 to be changed (e.g., depending on the specific configuration, position, etc. of the target tissue to be treated) to adjust the distance between the energy delivery members 602a, 602b and the tissue, the degree of contact, the pressure on the tissue, etc. For example, Figure 21AAn embodiment is shown in which the energy delivery member 602b is fixedly supported on (connected to) the catheter body 191, while the energy delivery member 602a is movable relative to the catheter body via the pusher 618. In such an embodiment, Figure 21A As shown, the pusher 618 can be located external to the catheter body 191. The pusher 618 can extend through the wall of the catheter body 191 (or can be embedded in the wall), can extend through the (main, working) lumen 193, or the catheter body 191 can include a separate (discrete) lumen configured to receive the pusher 618. Figure 21B As shown, embodiments are also contemplated herein in which each of the energy delivery members 602a, 602b is movable relative to the catheter body 191 (e.g., with corresponding pushers 618a, 618b). Pusher 618a enables axial movement of the delivery member 602a, and pusher 618b enables axial movement of the delivery member 602b, so that a clinician can selectively adjust the distance between the energy delivery members 602a, 602b, thereby adjusting the distance relative to the target tissue and the degree and force of contact with the target tissue located in the gap between the energy delivery members 602a, 602b.

[0315] Figure 22 Another embodiment of a (bypass) catheter is shown, which is identified by reference numeral 700. The catheter 700 is similar to the catheter 190 ( Figure 14 、 Figure 14A ) are substantially similar, and therefore, for the sake of brevity, we will only discuss their differences. As such, the same reference numerals will be used to refer to elements, structures, features, etc. that are common to catheters 190, 700.

[0316] The catheter 700 includes a flow circulator 702 rotatably located (positioned within, secured within) the catheter body 191 to direct blood flow through the catheter body. The flow circulator 702 can be configured for unidirectional or bidirectional rotation to direct blood flow through the catheter body 191 in a proximal direction (e.g., through a valve) (indicated by arrow 1) and / or in a distal direction (indicated by arrow 2), depending on the specific rotational direction of the flow circulator 702. Figure 22In the particular embodiment shown, the flow circulator 702 is shown as an impeller 704 comprising a shaft 706 supporting a head 706 having a plurality of blades 708 extending radially outward therefrom. It should be understood that other configurations of the flow circulator 702 are also contemplated, and that the flow circulator 702 may include (or may be configured as) any member or structure suitable for the intended purpose of directing blood flow through the catheter body 191 in the manner described herein. Further details regarding the flow circulator 702 (and embodiments thereof) are provided in U.S. patent application Ser. No. 16 / 881,727, the entire contents of which are incorporated herein by reference. The motor used to actuate the flow circulator may be located external to the catheter, or alternatively may be positioned internally within the catheter and may be powered by a battery or an external plug.

[0317] Although Figure 22 In the embodiment of FIG. 1 , the flow circulator 702 is shown as extending within (extending through) the (main, working) lumen 193 , but the catheter body 191 may alternatively include separate lumens for the flow circulator 702 and the auxiliary medical device M. For example, Figure 22A An embodiment is shown in which the catheter body 191 includes a (first) lumen 193i configured to receive (or otherwise house) the flow circulator 702, and a (second) lumen 193ii extending in parallel (or substantially parallel) relation to the lumen 193i and configured to receive (or otherwise house) the ancillary medical device M. The present disclosure also contemplates that the flow circulator 702 and the ancillary medical device M may be housed within the same lumen (e.g., lumen 193( Figure 22 In such embodiments, the catheter body 191 and the flow circulator 702 can be configured such that the flow circulator 702 can rotate around (or about) the auxiliary medical device M.

[0318] Figure 23 Another embodiment of a (bypass) catheter is shown, which is identified by reference numeral 800. The catheter 800 is similar to the catheter 140 ( Figure 12B ) is substantially similar in that the energy delivery member has the same configuration. However, it is Figure 12B The difference is that it includes a flow circulator 802, which is connected to the Figure 22 and Figure 22A The catheter 800 is designed to enhance flow in the distal and / or proximal directions in the same manner as the flow circulator 702 of the catheter 800. Therefore, for the sake of brevity, the catheter 800 will be discussed herein only with respect to any differences therebetween, and the same reference numerals will be used to refer to components of the catheter 800. Figure 12B The common elements, structures, features, etc. of the catheters.

[0319] Compared to the catheter 700 in which the flow circulator 702 is located (positioned, fixed) within the catheter body 191, the catheter 800 includes a flow circulator 802 supported by the energy delivery member 155B. More specifically, the flow circulator 802 is included (disposed) within the passage 156B of the delivery member 155B to guide blood flow through the energy delivery member 155B and replace the Figure 12B As discussed in conjunction with catheter 700, flow circulator 802 can direct blood flow through energy delivery member 155B in a proximal direction (indicated by arrow 1) or a distal direction (indicated by arrow 2), depending on the specific rotational direction. It should be noted that flow circulator 802 can be placed within the openings / passageways of other energy delivery members disclosed herein.

[0320] Now refer to 24A to 24F , a method of performing a surgical procedure (e.g., lithotripsy) will be discussed in conjunction with a surgical system 900. The surgical system includes a delivery (external) catheter 1000 and another embodiment of a (bypass) catheter disclosed herein, which is identified by reference numeral 1100. The (inner) catheter 1100 is coupled to the catheter 600 ( Figures 20 to 21B ) are substantially similar, and therefore, for the sake of brevity, we will only discuss any differences therebetween. As such, the same reference numerals will be used to refer to elements, structures, features, etc. that are common to catheters 600 and 1100. It should be noted that other catheters disclosed herein may also be used to perform lithotripsy and other procedures.

[0321] Delivery catheter 1000 is configured to receive catheter 1100 to facilitate placement thereof within access vessel A in a manner that allows access to target tissue (see also Figure 14D ), in the particular procedure shown, the target tissue is shown as a heart valve C of a patient. Although the delivery catheter 1000 and the catheter 1100 are each shown as including a circular (or substantially circular) transverse cross-sectional structure (e.g., diameter), alternative configurations are also contemplated herein. For example, it is contemplated that the delivery catheter 1000 and the catheter 1100 may have corresponding non-circular transverse cross-sectional structures (e.g., square, rectangular, hexagonal, octagonal, pentagonal, "house" shape, elliptical, star-shaped, etc.) to inhibit (if not completely prevent) relative rotation between the delivery catheter 1000 and the catheter 1100. In the case of a star-shaped transverse cross-sectional configuration, any star pattern may be used, including, for example, a six-pointed star, a "Star of David," etc. In certain embodiments, it is also contemplated that the delivery catheter 1000 and the catheter 1100 may have different transverse cross-sectional structures.

[0322] The catheter 600 ( Figures 20 to 21B), in catheter 1100, energy delivery members 602a, 602b are supported on (engaged with) a carrier 1102 (e.g., a rod, a wire, etc.), which is configured for insertion into the catheter body 191 (e.g., via the lumen 193) such that the catheter body 191 and the carrier 1102 are axially movable relative to each other (e.g., along the longitudinal axis X3).

[0323] During the surgical procedure, the delivery catheter 1000 is positioned in the access vessel A ( Figure 24A ) and advances toward the target tissue. Figure 24B As shown, in the specific procedure shown, the delivery catheter 1000 is advanced through the heart valve C, thereby separating the leaflets Li, Lii. The catheter 1100 is then advanced through the heart valve C, and the energy delivery member 602b is deployed by causing relative axial movement between the energy delivery member 602b and the catheter body 191. For example, the deployment of the energy delivery member 602b can be achieved by advancing the carrier 1102 distally relative to the catheter body 191 (and the delivery catheter 1000), and / or by retracting (pulling in) the catheter body 191 (and the delivery catheter 1000) relative to the carrier 1102. During deployment, as the energy delivery member 602b leaves the catheter body 191, the energy delivery member 602b will (automatically) move from a collapsed (first, compressed) configuration ( Figure 24B ) is reconfigured to the expanded (second) configuration ( Figure 24C ), which is facilitated by the flexible and resilient construction of the energy delivery member 602b. The delivery catheter 1000 and the catheter body 191 are then moved proximally (retracted) so as to be proximal to the target tissue, as shown in FIG. Figure 24D and the carrier 1102 moves proximally (retracts) so that the energy delivery member 602b contacts the heart valve C (or is positioned proximal to the heart valve), as shown Figure 24E In certain methods of use, it is contemplated that proximal movement of carrier 1102 may be accomplished in coordination with delivery catheter 1000 and catheter 1100 .

[0324] In Figure 24E After positioning the energy delivery member 602b in the manner shown, 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 the delivery catheter 1000) in a manner similar (if not identical) to that discussed above in connection with the deployment of the energy delivery member 602b. During deployment, similar to the energy delivery member 602b, upon exiting the catheter body 191, the energy delivery member 602a is (automatically) deployed from a collapsed (first, compressed) configuration to a collapsed (first, compressed) configuration. Figures 24B to 24D ) is reconfigured to the expanded (second) configuration ( Figure 24E), which is again facilitated by the flexible, resilient construction of the energy delivery member 602a described above. Figure 24F As shown, the energy delivery member 602a is positioned so that the energy delivery member 602a contacts the heart valve C (or is positioned in close proximity to the heart valve) so that the heart valve C (e.g., leaflets Li, Lii) is located between the energy delivery members 602a, 602b (e.g., within the space 616 between the energy delivery members 602a, 602b).

[0325] exist 24A to 24F In the illustrated embodiment of the present disclosure, the energy delivery member 602a is movably (e.g., slidably) supported on (engaged with) the carrier 1102, thereby allowing relative axial movement (e.g., along the longitudinal axis X3) between the energy delivery member 602a and the carrier 1102. To facilitate such movement, it is contemplated that the catheter 1100 may include (or may be used in conjunction with) a pusher 1104 ( Figure 24E 、 Figure 24F ), which is connected to the aforementioned propeller 618 ( Figure 21A ) are substantially similar (if not identical). More specifically, force is applied to pusher 1104, thereby advancing energy delivery member 602a distally toward heart valve C until energy delivery member 602a is positioned Figure 24F It is contemplated that the pusher 1104, such as pusher 618 (and 618a, 618b), can be fixedly connected to the energy delivery member 602a, or alternatively, the pusher 1104 and energy delivery member 602a can be selectively engaged, such as Figure 24E 、 Figure 24F As shown, this allows for selective engagement between the pusher 1104 and the energy delivery member 602b (eg, to adjust the position of the energy delivery member 602b). The pushers 1104, 618, etc. can also be configured to enable the energy delivery member to be pulled / moved in a proximal direction.

[0326] As described above in conjunction with the catheter 600 ( Figure 21A ) discussed above, the pusher 1104 can be located external to the catheter body 191, or extend through the catheter body 191 (or can be embedded within the catheter body), or extend through the (main, working) lumen 193, or the catheter body 191 can include a separate (discrete) lumen configured to receive the pusher 1104.

[0327] In Figure 24FAfter the target tissue is positioned between the energy delivery members 602a, 602b in the manner shown, energy is delivered to the target tissue via the energy emitters 197i, 197ii contained on the energy delivery members 602a, 602b, respectively (in the same manner as described above), thereby treating the target tissue (e.g., softening any calcium deposits on the leaflets Li, Lii).

[0328] It is contemplated that any catheter / device described herein may optionally include one or more steerable segments (regions) that are deflectable via one or more pull wires (or alternatively push wires) extending (embedded) within the catheter wall, such that the catheter can be reconfigured (i.e., deflected) between various configurations. Additionally (or alternatively), it is contemplated that any catheter (or other device) described herein may (optionally) include an integrated visualization device or system (e.g., a camera, etc.) to facilitate imaging during a surgical procedure.

[0329] To vary the tension of the draw wire, the catheter may include or be connected to any suitable mechanism, including, for example, wheels, ratchets, etc., to bend (deflect) the device, as described in further detail below. The term "maneuverability" as used herein should be understood to refer to the ability to turn, rotate, or otherwise deflect the catheter / device. Although in conjunction with Figure 14 The following discussion is provided with respect to catheter 190 , but it should be understood that the following principles apply equally to any catheter (or other device) described herein.

[0330] Now refer to Figures 25 to 27 To facilitate articulation (deflection) and reconfiguration, the catheter 900 may include multiple segments 1200 and one or more pull wires 1202. For clarity, Figures 25 to 27 , only the catheter body 191 is shown (e.g., the energy delivery member 195, the energy emitter 197, the connector 197a, and the energy source F have been removed from the illustration). The catheter 900 includes a plurality of inactive (passive) segments 1200i and a plurality of active (steerable, deflectable, articulatable) segments 1200a connected to a plurality of pull wires 1202. The inactive segments 1200i and the active segments 1200a are staggered along the longitudinal axis X defined by the catheter body 191, such that the catheter 900 alternates between the inactive segments 1200i and the active segments 1200a.

[0331] Each active segment 1200a is connected to a corresponding (single) pull wire 1202 that extends through (e.g., within) the outer wall of the catheter 900 (e.g., such that the pull wires 1202 are embedded in the catheter body 191), whereby the number of pull wires 1202 corresponds to the number of active segments 1200a. Upon application of an axial (tensile) force to each of the pull wires 1202, the corresponding active segment 1200a deflects (articulates), thereby causing the catheter 900 to be in a first (initial, normal) configuration ( Figure 25 ) (in which the catheter 900 comprises a (substantially) linear configuration) and a second (subsequent, deflected) configuration ( Figure 27 )(the catheter 900 includes non-linear configurations therein) reconfiguration (active steering).

[0332] The use of a single pull wire 1202 in conjunction with each movable segment 1200a reduces the number of pull wires 1202 required, thereby reducing the complexity of the construction and operation of the catheter 900. It is also contemplated that other embodiments may include multiple independently movable pull wires 1202. In the embodiment shown, each pull wire 1202 is received in a corresponding channel 1204 ( Figure 26 ), the channel extends through the outer wall 901o of the catheter 900 in a (substantially) parallel relationship to the longitudinal axis X (e.g., such that the pullwire 1202 is embedded within the catheter 900). In an alternative embodiment, the pullwire extends through a lumen within the main central lumen.

[0333] To facilitate application of axial force to the pull wires 1202, in some embodiments, the catheter 900 may include (or may be connected to) a plurality of corresponding activation mechanisms 1206 (e.g., such that the number of pull wires 1202 corresponds to the number of activation mechanisms 1206). In the illustrated embodiment, the catheter 900 includes a (first) activation mechanism 1206i connected to the pull wire 1202i and a (second) activation mechanism 1206ii connected to the pull wire 1202ii. The activation mechanisms 1206 may include any structure or mechanism suitable for applying an axial force to the pull wires 1202 that causes the catheter 900 to deflect as needed or desired, such as, for example, a rotating wheel, a pulley system, or the like. In some embodiments, the active segments 1200a, the pull wires 1202, and the activation mechanisms 1206 may be configured (and connected) such that each pull wire 1202 can act independently, thereby causing the corresponding segment 1200a to deflect (steer) in only one direction. In other embodiments, pull wires 1202 may be provided on various circumferential surfaces of the catheter 900 to facilitate steering of the distal region of the catheter in various directions. For example, the pull wires may be in a neutral position, in which distal movement deflects the catheter in a first direction, and proximal movement deflects the catheter in a second direction. In alternative embodiments, push wires may be provided rather than pull wires to achieve deflection / articulation.

[0334] In the illustrated embodiment, the catheter 900 includes: a first inactive segment 1200i1; a first active segment 1200a1 located distally of the inactive segment 1200i1; a second inactive segment 1200i2 located distally of the active segment 1200a1; and a second active segment 1200a2 located distally of the inactive segment 1200i2. In addition, the catheter 900 includes corresponding first and second pullwires 1202i, 1202ii located within the channel 1204. Figure 26 However, it is also contemplated that the first draw wire 1202i and the second draw wire 1202ii may be located within separate channels 1204 (eg, such that the number of channels 1204 corresponds to the number of draw wires 1202).

[0335] Pull wires 1202i, 1202ii are connected to segments 1200a1, 1200a2 at connection points 1208i, 1208ii, respectively (in addition to activation mechanisms 1206i, 1206ii) to facilitate activation of the catheter 900 in the first configuration ( Figure 25 ) and the second configuration ( Figure 27 More specifically, after the catheter 900 is reconfigured / deflected, the active segments 1200ai, 1200aii define respective first and second bends 1210i, 1210ii ( Figure 27 ), which may be substantially similar (e.g., identical) or dissimilar, depending on, for example, the specific configuration of segments 1200a1, 1200a2, the materials of construction used in catheter 900, the specific requirements of the surgical procedure for catheter 900, etc. Figure 27 While the intermediate bends 1210i, 1210ii are each illustrated as being (approximately) equal to 90 degrees, it is contemplated that the bends 1210i, 1210ii may be substantially within a range of approximately 0 degrees to approximately 270 degrees, depending on the specific configuration of the segments 1200a1, 1200a2, the requirements of the surgical procedure, the specific anatomy of the patient, etc. For example, in one specific embodiment, it is contemplated that the segment 1200a1 may be configured such that the bend 1210i is substantially within a range of approximately 0 degrees to approximately 180 degrees (e.g., approximately 90 degrees to approximately 180 degrees), and the segment 1200a2 may be configured such that the bend 1210ii is substantially within a range of approximately 0 degrees to approximately 270 degrees (e.g., approximately 90 degrees to approximately 270 degrees).

[0336] In the particular embodiment shown, connection points 1208i and 1208ii are shown as being (approximately) angularly aligned (e.g., along the circumference of catheter 900), which promotes deflection of segments 1200a1 and 1200a2 in similar (e.g., the same) directions, as shown. Figure 27However, it is also contemplated that the connection points 1208i and 1208ii may be angularly offset to facilitate deflection of the segments 1200a1 and 1200a2 in different directions. For example, the connection points 1208i and 1208ii may be (substantially) diametrically opposed such that the bends 1210i and 1210ii defined by the segments 1200a1 and 1200a2, respectively, bend in (substantially) opposite directions.

[0337] It should be understood that the number of bendable regions can vary, such that there is only one bendable region, or there are two bendable regions (e.g. Figure 27 As shown), or there are more than two bendable regions. The number of drawn or pushed wires will vary to accommodate the number of bendable regions.

[0338] Various mechanisms and features can be used to deflect (steer) the catheters disclosed herein, such as disclosed in PCT application PCT / US22 / 51599 filed on December 2, 2022, and U.S. Publication No. 2021 / 0259860. The entire contents of both of these applications are incorporated herein by reference. A wire for applying a torsional force to rotate the catheter (as disclosed in Publication No. 2021 / 0259860) can be used with any catheter disclosed herein.

[0339] As described above, the catheters disclosed herein can have a circular (or substantially circular) or non-circular transverse cross-section (diameter) and / or a circular (or substantially circular) or non-circular lumen.

[0340] The catheter of the present invention is preferably placed in a minimally invasive manner, most commonly percutaneously, such as through the femoral or radial artery, and advanced intravascularly (through the vascular system) to the target tissue site, such as near a blood clot. The catheter is configured for temporary placement and removal after the procedure. Alternatively, the catheter may be left in place for a period of time.

[0341] While surgical procedures performed on anatomical valves (eg, a patient's heart valves) are generally discussed herein, it should be understood that the various catheter embodiments described herein may also be configured for use during treatment of other areas and tissues.

[0342] While described in conjunction with blood clot treatment, the catheter disclosed herein can be used to fragment or dissolve and / or deliver drugs to other areas of the body for other surgical procedures requiring immediate reperfusion, sustained and / or controlled blood flow during surgery. It is ideally suited for use in any luminal structure that may have an obstruction.

[0343] It should be understood that the above-mentioned specific embodiments are shown and described only as demonstrations. Without departing from the scope and spirit required by the present disclosure, the principles and features of the present invention can be used in various embodiments. The above-mentioned embodiments do not limit the scope of the present disclosure, and those skilled in the art will understand that, without departing from the true spirit and scope of the present invention, various changes can be made and the elements of the present invention can be replaced with equivalents. In addition, many modifications can be made to adopt specific situations, materials, material compositions, processes, one or more process steps to meet the goals, spirit and scope of the present invention. All such modifications are intended to fall within the scope of the appended claims.

[0344] It will be understood by those skilled in the art that elements and features shown or described in conjunction with one embodiment may be combined with elements and features of another embodiment without departing from the scope of the present invention.

[0345] Where a range of values ​​is provided, it is understood that every intervening value between the upper and lower limit of the range is encompassed within the invention.

[0346] It must be noted that as used herein and in the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise.

[0347] In this disclosure, terms such as "approximately," "substantially," and the like should be understood to allow for variations in any numerical range or concept associated therewith. For example, the use of terms such as "approximately" and "substantially" should be understood to encompass variations of approximately 25% (e.g., to allow for manufacturing tolerances and / or design deviations).

[0348] Although terms such as "first," "second," and "third" 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 because these terms are used to distinguish one operation, element, component, region, or section from another operation, element, component, region, or section. Therefore, 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 this disclosure.

[0349] Each claim is incorporated into this specification as further disclosure and represents an embodiment of the present disclosure. In addition, the phrases "at least one of A, B, and C" and "A and / or B and / or C" should each be interpreted to include only A, only B, only C, or any combination of A, B, and C.

[0350] Various combinations of all the above devices and methods can be used sequentially and / or simultaneously in the same program.

Claims

1. A catheter for intracavitary lithotripsy, comprising: 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 outwardly therefrom, the energy delivery member comprising: main body; a passage extending through the body in generally parallel relationship to the longitudinal axis; a valve positioned within the passageway to inhibit blood flow through the energy delivery member; and an energy transmitter configured to deliver energy to the target tissue to facilitate treatment thereof; and A connector extends from the energy transmitter to an external energy source to supply energy to the energy transmitter.

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

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

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

5. The catheter of claim 4, wherein the energy delivery member comprises: proximal portion; distal portion; as well as an intermediate portion positioned between the proximal portion and the distal portion, wherein, when the energy delivery member is expanded, the proximal portion and the distal portion each define a transverse cross-sectional dimension, and the intermediate portion defines a second transverse cross-sectional dimension that is smaller than the transverse cross-sectional dimensions of the proximal portion and the distal portion, such that the energy delivery member includes a waist defining a gap configured to receive the target tissue.

6. A catheter according to claim 4, wherein the energy delivery member comprises a generally annular configuration.

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

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 configured as a discrete structure axially spaced apart 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 for intracavitary lithotripsy, comprising: a catheter body defining a longitudinal axis; an impeller to direct blood flow; An energy delivery member extending radially outward from the catheter body, the energy delivery member comprising: a body having a generally annular transverse cross-sectional configuration; and an energy emitter configured to deliver energy to target tissue to facilitate treatment thereof; and A connector extends from the energy transmitter to an external energy source to supply energy to the energy transmitter.

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

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

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

20. The catheter of claim 19, wherein the second lumen is configured to receive an ancillary medical device.

21. The catheter of claim 16, wherein the energy delivery member is expandable and comprises: proximal portion; distal portion; as well as an intermediate portion positioned between the proximal portion and the distal portion, wherein, when the energy delivery member is expanded, the proximal portion and the distal portion each define a first transverse cross-sectional dimension and the intermediate portion defines a second transverse cross-sectional dimension that is smaller than the first transverse cross-sectional dimension, such that the energy delivery member includes a waist defining a gap configured to receive the target tissue.

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

23. The catheter of claim 22, wherein the energy emitting surfaces are configured to press against opposing sides of tissue and on different sides of the waist.

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

25. A method of performing an intracavitary lithotripsy procedure, the method comprising: a) inserting a catheter, said catheter comprising: a catheter body; and an energy delivery member extending radially along the catheter body, the energy delivery member including a passageway extending therethrough; b) intermittently inhibiting blood flow through the energy delivery member using a valve supported within the passageway; c) positioning the energy delivery member adjacent to the target tissue; and d) applying energy to the energy delivery member to treat the target tissue.

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

27. The method of claim 26, wherein positioning the energy delivery member proximate 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. The method of claim 25, further comprising directing blood flow through the catheter by rotating an impeller positioned within the catheter body.

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

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

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