Abstract: A method is disclosed for removing a vascular occlusion, such as a clot, from a blood vessel. A tubular sheath is inserted into the vessel and a self-expanding Nitinol mesh filter is deployed from a distal end of the tubular sheath at a location proximal to a clot. An inner catheter is advanced through the tubular sheath and through the mesh filter for contacting the clot. An expandable agitation element is provided along a distal end portion of the inner catheter for cutting or chopping the clot, thereby facilitating removal of the clot and improving blood flow through the vessel. Resulting clot particles are captured by the mesh filter. Negative pressure may be applied along a proximal end portion of the sheath for aspirating remaining particles. Certain embodiments of the method are well-suited for treating deep vein thrombosis and do not require the use of thrombolytic drugs.

Abstract: An atherectomy system includes a handle having a handle housing, with a drive member extending through the handle housing and operably coupled to an atherectomy burr. A drive mechanism is disposed within the handle housing and is adapted to rotatably engage the drive member. The drive mechanism may include an electric drive motor, a drive gear that is rotatably engaged with the electric drive motor and a driven gear that is coupled with the drive member and is engaged with the drive gear such that rotation of the driven gear causes rotation of the drive member. The drive mechanism may be configured to enable a rotation speed of the atherectomy burr of up to at least about 200,000 revolutions per minute (rpm).

Abstract: A dilation catheter includes a shaft and an expandable element. The shaft includes a proximal portion and a distal portion. The distal portion includes a tip and a bend. The tip is sized and configured to pass through an isthmus of a Eustachian tube (ET). The bend is proximal to the tip. The bend is formed at an angle configured to provide insertion of the tip into the isthmus of the ET via an ear canal associated with the ET. The expandable element is disposed at the distal portion of the shaft. The expandable element is configured to transition between a non-expanded state and an expanded state. The expandable element in the non-expanded state is configured for insertion into the ET via the isthmus. The expandable element in the expanded state is configured to dilate the ET.

Abstract: Devices, systems, and methods for removing obstructions from body lumens are disclosed herein. In some embodiments, a system for removing a thrombus includes an interventional element configured to be disposed proximate to or adjacent to a thrombus within a blood vessel. The system can include a signal generator in electrical communication with the interventional element. The signal generator can be configured to deliver an electrical signal to the interventional element. The electrical signal can include a waveform having a positive phase having a peak positive current and a first duration, and a negative phase having a peak negative current and a second duration. A magnitude of the peak positive current can be greater than a magnitude of the peak negative current, and the first duration can be greater than the second duration.

Abstract: In some examples, a catheter includes an elongated body defining an inner lumen and comprising an expandable member disposed at a distal portion of the elongated body, and a rotatable cutting tool located within an inner lumen of the elongated body, the rotatable cutting tool configured to segment a thrombus into smaller pieces while an aspiration force pulls the thrombus proximally into the inner lumen. In some examples, the catheter further comprises an intermediate structure oriented radially between the rotatable cutting tool and an interior surface of the elongated body, the intermediate structure configured to prevent the cutting tool from contacting the interior surface of the elongated body. In some examples, a stopper is configured to limit movement of the cutting tool distally past a distal end of the expandable member.

Abstract: Rotational atherectomy devices and systems can remove or reduce stenotic lesions in blood vessels by rotating one or more abrasive elements within the vessel. The abrasive elements are attached to a distal portion of an elongate flexible drive shaft that extends from a handle assembly that includes a driver for rotating the drive shaft. In particular implementations, individual abrasive elements are attached to the drive shaft at differing radial angles in comparison to each other (e.g., configured in a helical array). The centers of mass of the abrasive elements can define a path that spirals around the drive shaft in a direction that is opposite to the wind direction of filars of the drive shaft, and opposite to the direction of rotation. In some embodiments, a concentric abrasive tip member is affixed to and extends distally from a distal-most end of the drive shaft.

Abstract: An actuated telescoping system for navigation within a vascular lumen and thrombectomy of a thrombus. The system includes a tubular catheter member having an open distal end defining a catheter lumen, a vacuum source, a rotational drive system, a flexible shaft having a channel coupled to the rotational drive system for rotational movement in response thereto, and an optional guidewire selectively inserted at least partially within the flexible shaft. The flexible shaft is at least partially disposed within the tubular catheter member configured for uncoupled rotational and translational motion therein and to optionally define a corkscrew motion in response to rotational driving force by the drive system that results in formation of hydrodynamic vortices within the catheter lumen.

Abstract: Intraluminal devices and methods for removing an obstruction from a blood vessel using an intraluminal device are provided. The intraluminal device can include a flexible shaft and an expandable wire mesh structure extending from the flexible shaft, the wire mesh structure including at least one first expandable section having a first wire arrangement pattern and at least one second expandable section having a second wire arrangement pattern different from the first wire arrangement pattern. In addition, interstices in the at least one second expandable section.

Abstract: The invention provides, in various embodiments, aspects of soft tissue anchors, adjustable length/tension slings, interconnects between slings and soft tissue anchors, delivery devices and systems for implanting supportive slings, and methods relating to anchoring, 5 adjusting and implanting supportive slings.

Abstract: An ultrasonic surgical instrument and method of assembly with a predetermined alignment includes first and second modular assemblies and an electrical lockout. The first modular assembly includes at least a portion of an end effector configured to manipulate a tissue. The second modular assembly includes a transducer power circuit and an activation switch electrically connected to the transducer power circuit. The electrical lockout is electrically connected to the transducer power circuit and configured to inhibit the activation switch from powering the ultrasonic transducer with the first and second modular assemblies misaligned from the predetermined alignment such that the first and second modular assemblies are in a locked-out state. The electrical lockout is further configured to allow the activation switch to power the ultrasonic transducer with the first and second modular assemblies in the predetermined alignment such that the first and second modular assemblies are in an operational state.

Abstract: A wire for use with a vascular treatment device may have a proximal end, a distal end, and a main shaft extending therebetween. The distal end may have a distal free end and a first segment. The first segment may extend from the main shaft and may be biased to a first included angle that is defined between the main shaft and the first segment and less than 180 degrees.

Abstract: A method of treating a vessel in a subject comprises the steps of advancing a device distally across a treatment zone in a vessel, wherein the device comprises an elongated catheter having a lumen and a distal end, and a radially expansive treatment element disposed in the lumen and configured for axial movement relative to the catheter; deploying the radially expansive treatment element proud of the distal end of the catheter to radially expand and circumferentially impress against the vessel lumen at a distal end of the treatment zone; and withdrawing the deployed radially expansive treatment element proximally along the treatment zone with the treatment element circumferentially impressed against the vessel lumen to mechanically and circumferentially denude the treatment zone of the vessel. The radially expansive treatment element is then recaptured into the lumen of the catheter, before the device is withdrawn from the treated vessel.

Abstract: A tissue-removing catheter for removing tissue in a body lumen includes a tube extending axially along the catheter. A junction box housing is located at a distal end of the tube. An elongate body extends distally from the junction box housing. The elongate body is sized and shaped to be received in the body lumen. A gear assembly is disposed in the junction box housing. The gear assembly engages the elongate body for rotating the elongate body. A tissue-removing element is mounted on a distal end portion of the elongate body. The tissue-removing element is configured to remove the tissue as the tissue-removing element is rotated by the elongate body within the body lumen.

Abstract: Inverting tube thrombectomy apparatus for removing clot that are configured to prevent compression of the apparatus that may separate the distal end of the apparatus from the clot and may make it difficult to advance the apparatus to engage with the clot, particularly in a tortious vessel. The apparatuses and methods of using them described herein may be adapted to prevent tension in the flexible tube that is rolling and inverting over the distal end of the inversion support catheter when capturing a clot. Also described herein are inverting tube thrombectomy apparatus that are configured to reload either automatically or manually within the vessel to capture additional clot material.

Abstract: Example medical devices are disclosed. An example medical device includes a handle having a distal end region, a proximal end region and an inner chamber. The medical device also includes a guidewire brake including an actuation member coupled to a first gripping member and a second gripping member. The first gripping member and a second gripping member are disposed within the inner chamber of the handle and at least a portion of the actuation member is positioned along an outer surface of the handle. Further, the first gripping member and the second gripping member are configured to shift between an unclamped configuration and a clamped configuration.

Abstract: The present disclosure relates to a basket for a catheter designed to be deployed in complex vasculature to optimally treat vascular and arterial disease conditions such as blood clots, blood emboli, and deep vein thrombosis. The basket may comprise a shaft with a plurality of cuts along a portion of its length to form a plurality of tines that provide support for a plurality of porous tubes to form the limbs of the basket. The limbs of the basket expand radially away from the longitudinal axis of the basket when the longitudinal length of the basket is reduced. The limbs may also be connected to a drug delivery system, and in this manner, baskets of the present disclosure allow for the use of both mechanical and pharmaceutical means of thrombolysis.

Abstract: The present invention comprises at least sensing, monitoring, and display of motor current which is then used in various embodiments of a rotational atherectomy device to determine and/or predict, among other things, treatment progression, treatment completion, optimal rotational speed, optimal advancement or traversal speed during treatment, whether stall appears imminent, and/or reacting to stop motor rotation before a stall occurs. In some embodiments, the determination or prediction results in an automatic, or preprogrammed adjustment by the control unit of the rotational speed of the rotating drive shaft and associated tool.

Abstract: A tissue-removing catheter for removing tissue in a body lumen includes an elongate body having an axis, and proximal and distal end portions spaced apart from one another along the axis. The elongate body is sized and shaped to be received in the body lumen. A tissue-removing element is mounted on the distal end portion of the elongate body. The tissue-removing element is configured to remove the tissue as the tissue-removing element is rotated by the elongate body within the body lumen. An inner liner is received within the elongate body and defines a guidewire lumen. The inner liner is coupled to the tissue-removing element at a distal end portion of the inner liner. A coupling assembly is disposed in the tissue-removing element for coupling the inner liner to the tissue-removing element. The coupling assembly includes a bushing attached directly to the distal end portion of the inner liner.

Abstract: An anastomosis clamp (1) and a delivery system thereof, where the anastomosis clamp (1) includes inner lancets (102, 602), round corners (103, 603), and outer rings (101, 601) that are sequentially connected; the delivery system may be used in cooperation with the anastomosis clamp (1); and the delivery system includes a distal end (2), a middle flexible sheath (3), and a handle (4).

Abstract: An aspiration catheter is provided including a proximal section and a distal section extendable through the proximal section. A vacuum transfer tool may be coupled to a proximal end of the proximal section. The vacuum transfer tool may include a proximal transfer tube and a distal transfer tube, each having an aspiration port in communication with a vacuum source. The proximal transfer tube may be removably received within a proximal end of the distal transfer tube. The distal section of the catheter may be inserted into the proximal section through the proximal transfer tube. The proximal transfer tube may maintain a vacuum around a proximal end of the distal section of the catheter such that when the distal section is removed by decoupling the proximal and distal transfer tubes, the vacuum within the distal transfer tube and proximal section of the catheter is maintained, preventing an escape of any clots.

Abstract: Methods of heart valve decalcification may include mechanically removing calcium deposits on a heart valve, and removing debris from the mechanical decalcification via suction. The mechanical removal of the calcium deposits may be accomplished with a burr and/or an ultrasonic device. In some embodiments, mechanical removal of the calcium deposits may be accomplished with a handheld mechanical decalcification device comprising a bur extending from a hand piece. A catheter system for removing plaque deposits from a heart valve may include at least one mechanical decalcification device configured for cleaning the edges of heart valve leaflets, and at least one active aspiration device. The at least one mechanical decalcification device may comprise a bur and/or an ultrasonic device. The system may additionally include a deployable net apparatus configured to encompass at least a portion of a heart valve.

Abstract: Rotational atherectomy devices and systems can remove or reduce stenotic lesions in blood vessels by rotating an abrasive element within the vessel. The abrasive element can be attached to a distal portion of an elongate flexible drive shaft that extends from a handle assembly.

Abstract: Medical systems and methods for making and using medical systems are disclosed. Example medical systems may include an atherectomy system configured to engage and remove plaque from walls in vessels of a vascular system. The atherectomy system may include a drive shaft, a rotational tip coupled to an end of the drive shaft, a drive mechanism coupled to the drive shaft to rotate the rotational tip, and control configurations to control settings of operational modules of the atherectomy system. The control configurations may be configured to change settings of multiple operational modules of the atherectomy system in response to a single actuation of an actuator to facilitate use of the atherectomy system in a vasculature of a patient.

Abstract: Rotational atherectomy devices and systems can remove or reduce stenotic lesions in blood vessels by rotating one or more abrasive elements within the vessel. The abrasive elements are attached to a distal portion of an elongate flexible drive shaft that extends from a handle assembly that includes a driver for rotating the drive shaft. In particular implementations, the handle assembly encapsulates an electric motor assembly, a pump assembly, and a controller assembly.

Abstract: Meniscal repair devices, systems, and methods are provided.

Abstract: A tissue-removing catheter for removing tissue in a body lumen includes a catheter body assembly having an axis and proximal and distal end portions spaced apart from one another along the axis. At least a portion of the catheter body assembly is sized and shaped to be received in the body lumen. A handle is mounted to the proximal end portion of the catheter body assembly and operable to cause rotation of the catheter body assembly. The handle includes internal handle components that interface with the catheter body assembly. The internal handle components provide at least four interface locations spaced axially along the catheter body assembly. A tissue-removing element is mounted on the distal end portion of the catheter body assembly. The tissue-removing element is configured to remove the tissue as the tissue-removing element is rotated by the catheter body assembly within the body lumen.

Abstract: Medical systems and methods for making and using medical systems are disclosed. Example medical systems may include an atherectomy system configured to engage and remove plaque from walls in vessels of a vascular system. The atherectomy system may include a drive shaft, a rotational tip coupled to an end of the drive shaft, a motor coupled to the drive shaft to rotate the rotational tip, and a controller configured to control a motor state of the motor. The controller may adjust a range of possible load outputs from the motor and/or a maximum load output from the motor to account for external loads acting on the drive shaft and/or rotational tip rotated by the motor and facilitate passing an occlusion in a vasculature of a patient.

Abstract: A medical device for removing an object in a body lumen includes a catheter and a drive device. The drive device includes a hub support portion with which a hub portion of the catheter is interlocked. The hub portion has first and second engagement portions interlocked with the hub support portion. The hub support portion includes a rotation blocking portion that is engaged with the first engagement portion to block the hub portion from rotating with respect to the hub support portion, a movement blocking portion that is engaged with the second engagement portion to block movement of the hub portion with respect to the hub support portion in an axial direction, and a releasing portion that releases a state in which a rotation of the hub portion is blocked while maintaining a state in which movement of the hub portion is blocked.

Abstract: Systems and methods for removal of thrombus from a blood vessel in a body of a patient are disclosed herein. The method can include: providing a thrombus extraction device including a proximal self-expanding member formed of a fenestrated structure, a substantially cylindrical portion formed of a net-like filament mesh structure having a proximal end coupled to a distal end of the fenestrated structure; advancing a catheter constraining the thrombus extraction device through a vascular thrombus, deploying the thrombus extraction device by stacking a portion of the net-like filament mesh structure outside of the catheter by distally advancing the self-expanding member until the self-expanding member is beyond a distal end of the catheter; retracting the self-expanding member to unstack the portion of the net-like filament mesh structure and to capture the portion of the thrombus; and withdrawing the thrombus extraction device from the body.

Abstract: Various embodiments of the systems, methods and devices are provided for breaking up calcified lesions in an anatomical conduit More specifically, an electrical arc is generated between two spaced-apart electrodes disposed within a fluid-filled balloon, creating a subsonic pressure wave. In some embodiments, the electrodes comprise a plurality of points that allow the electrical arc to form at any one of the plurality of points to, among other things, extend the electrode life.

Abstract: A surgical tool, systems, and method for cleaning an anatomical space is provided. At least one brush is disposed on a shaft extending through a tube. The tube includes a corresponding brush slot for each brush. A motor is operable to rotate the shaft to cause the at least one brush to move from a closed position to a cleaning position. The at least one brush is positioned entirely inside of the tube when in the closed position and at least partially outside of the tube when in the cleaning position. A fluid source is operable to supply fluid to the at least one brush as the at least one brush passes through the brush slot.

Abstract: Disclosed herein is a rotary embolectomy device. The device includes a rotatable bit which contacts a blood clot within a cannula, thereby disintegrating the clot. The clot can be removed by means of suction, complete disintegration, or a collecting basket.

Abstract: A system for removal of blood or thrombus includes an aspiration catheter having an elongate shaft including an aspiration lumen having proximal end configured to couple to a vacuum source, and a distal end having an orifice, an elongate member configured for placement through the aspiration lumen and having a distal portion including a disruption element configured to disrupt thrombus within the aspiration lumen, and a monitoring device configured for removable connection in between the aspiration catheter and the vacuum source, and including a housing, a pressure sensor in fluid communication with an interior of the housing, a measurement device coupled to the pressure sensor and configured for measuring deviations in fluid pressure, and a communication device coupled to the measurement device and configured to generate an alert signal when a deviation in fluid pressure measured by the measurement device exceeds a pre-set threshold.

Abstract: A burring device for burring tissue, bone, or cartilage may include a shaft including a burr attached at a distal end. The shaft may be configured at a proximal end to be removably attached to a motor configured to drive a rotational movement of the burr. The device may include a housing configured to house the shaft in a lengthwise direction and at least a portion of the burr. The housing may be configured to allow rotational movement of the burr, and may include, at a distal portion, an opening through which at least a portion of the burr can extend beyond the housing. The shaft or the housing may be configured to be adjustably movable in a linear direction relative to each other so that at least a portion of the burr can extend beyond a distal end of the housing.

Abstract: An annuloplasty prosthesis and delivery system for implanting the prosthesis adjacent an annulus of a heart valve having leaflets for adjusting the annulus to improve valve function includes a ring prosthesis made of shape memory material and having tissue attachment members which attach to the annulus in the atrium and commissural legs extending from the ring between the leaflets and secure against the underside of the valve in the ventricle. The prosthesis is carried via an orientation loop and attaches to the heart tissue such that when the prosthesis is manipulated and relaxed the annulus is adjusted to reduce or eliminate regurgitation.

Abstract: Rotational atherectomy devices and systems can remove or reduce stenotic lesions in blood vessels by rotating an abrasive element within the vessel. The abrasive element can be attached to a distal portion of an elongate flexible drive shaft that extends from a handle assembly. In particular embodiments, the handle assembly includes a compressed gas driven turbine member that drives rotation of the drive shaft. The turbine member can be rotatably attached to a carriage that is longitudinally translatable in relation to a housing of the handle assembly. The handle assembly can include a latch mechanism that when actuated allows the carriage to translate to a proximal-most position. While the carriage is in the proximal-most position, an open pathway is created so that a guidewire can be slidably passed through the handle assembly and a lumen of the drive shaft.

Abstract: Rotational atherectomy devices and systems can remove or reduce stenotic lesions in blood vessels by rotating one or more abrasive elements within the vessel. The abrasive elements are attached to a distal portion of an elongate flexible drive shaft that extends from a handle assembly that includes a driver for rotating the drive shaft. In particular implementations, the handle assembly encapsulates an electric motor assembly, a pump assembly, and a controller assembly.

Abstract: An endotracheal tube inserting device (1;1?) of the kind comprising a stylet part (3; 3?), a handle part (2;2?), and an endotracheal tube (1) on the stylet part (3), and a tube ejecting mechanism (65; 65?) to advance the endotracheal tube off the stylet part (3; 3?) once inserted in the correct position inside the patient's airways.

Abstract: A tissue resecting end effector includes a housing, a shaft extending from the housing, and a drive assembly operably coupled to the shaft such that a rotational input provided to the drive assembly effects the rotation and reciprocation of the shaft relative to the housing. The assembly includes a proximal portion translationally fixed and rotatably coupled to the housing and configured to receive the rotational input and to rotate relative to the housing in response thereto, a distal portion translationally and rotatably coupled to the housing and operably coupled to the proximal portion such that the rotation of the proximal portion relative to the housing effects rotation and reciprocation of the distal portion relative to the housing to thereby rotate and reciprocate the first shaft relative to the housing, and a seal member disposed on the proximal portion or the distal portion and configured to selectively establish a seal therebetween.

Abstract: A method for performing a therapeutic intervention in a pericardial space of a heart includes delivering a catheter into a right atrium of the heart and steering the catheter so that a distal end of the catheter is positioned adjacent an access site in the right atrium. The distal end of the catheter is anchored in a heart wall of the right atrium adjacent the access site and the heart wall is inverted to separate an exterior surface of the inverted heart wall from contact with parietal pericardial tissue. The inverted heart wall is penetrated to provide access to the pericardial space around the heart. A device is delivered through the penetrating in the inverted heart wall to perform the therapeutic intervention in the pericardial space.

Abstract: An atherectomy system includes an electric drive mechanism that is adapted to rotatably actuate an atherectomy burr and a controller that is adapted to regulate operation of the electric drive mechanism. The controller regulates operation of the electric drive mechanism in accordance with a power input limit value that limits how much power can be put into an atherectomy burr and an energy input limit value that limits how much energy can be put into the atherectomy burr. The controller may also regulate operation of the electric drive mechanism in accordance with a dynamic torque limit.

Abstract: A cage can be positioned around a medical balloon, such as an angioplasty balloon, to assist in a medical procedure. The cage can include a plurality of strips, each extending between a set of rings including first and second rings. As the balloon expands, the first and second rings move closer together and allow the strips to expand outward. The cage may have wedge dissectors on the strips.

Abstract: Rotational atherectomy devices and systems can remove or reduce stenotic lesions in blood vessels by rotating one or more abrasive elements within the vessel. The abrasive elements are attached to a distal portion of an elongate flexible drive shaft that extends from a handle assembly that includes a driver for rotating the drive shaft. In particular implementations, the handle assembly encapsulates an electric motor assembly, a pump assembly, and a controller assembly.

Abstract: A cage can be positioned around a medical balloon, such as an angioplasty balloon, to assist in a medical procedure. The cage can include a plurality of strips, each extending between a set of rings including first and second rings. As the balloon expands, the first and second rings move closer together and allow the strips to expand outward. The cage may have wedge dissectors on the strips.

Abstract: A matter conveyance system is located within a catheter and transports thrombus from a proximal portion of the catheter to a distal end of the catheter. In one example, the matter conveyance system is a screw or helix that rotates to cause movement of the thrombus.

Abstract: A surgical instrument including a reusable and sterilizable hub assembly and a releasably connectable disposable blade assembly allows multiple reuse of the hub assembly in conjunction with single use disposable blade assemblies.

Abstract: Methods for performing non-invasive thrombolysis with ultrasound using, in some embodiments, one or more ultrasound transducers to focus or place a high intensity ultrasound beam onto a blood clot (thrombus) or other vascular inclusion or occlusion (e.g., clot in the dialysis graft, deep vein thrombosis, superficial vein thrombosis, arterial embolus, bypass graft thrombosis or embolization, pulmonary embolus) which would be ablated (eroded, mechanically fractionated, liquefied, or dissolved) by ultrasound energy. The process can employ one or more mechanisms, such as of cavitational, sonochemical, mechanical fractionation, or thermal processes depending on the acoustic parameters selected. This general process, including the examples of application set forth herein, is henceforth referred to as “Thrombolysis.

Abstract: Devices, systems, and methods are provided for breaking a kidney stone(s) into smaller particles, fragments, and/or stone dust; and removing the same from a patient. The medical device may include a tube having a distal end, a proximal end, a port located proximal of the distal end, and a length of the tube extending between the proximal end and the distal end. A first portion of the tube may be proximal of the port and have a first cross-sectional area, while a second portion of the tube may be distal of the port and have a second cross-sectional area smaller than the first cross-sectional area. A first lumen may extend from the proximal end to the distal end of the tube. A second lumen may in communication with the port to fluidly connect the proximal end of the tube with the port.

Abstract: The devices and method described herein allow for therapeutic damage to increase volume in these hyperdynamic hearts to allow improved physiology and ventricular filling and to reduce diastolic filling pressure by making the ventricle less stiff.

Abstract: The present disclosure provides an apparatus including: (a) a frame (102) having a first end (104) and a second end (106), wherein the frame includes a plurality of struts (108) arranged between the first end and the second end of the frame, (b) a plurality of channels (110) disposed within the plurality of struts of the frame, (c) an infusion balloon (112) coupled to the frame and arranged such that, in an expanded condition, the frame provides a plurality of openings (114) that the infusion balloon is configured to expand through and extend radially outward from the frame, thereby defining a plurality of grooves (116), (d) a plurality of holes (118) defined in the frame and configured to permit fluid communication between the plurality of channels and the plurality of grooves, and (e) an infusion hub (120) arranged at the first end or the second end of the frame including a reservoir in fluid communication with the plurality of channels.