122 at a second time after the switch opens and to determine, based on the result of measuring the remaining capacitor voltage, if a fault condition has occurred.
A61B 17/22 - Implements for squeezing-off ulcers or the like on inner organs of the bodyImplements for scraping-out cavities of body organs, e.g. bonesSurgical instruments, devices or methods for invasive removal or destruction of calculus using mechanical vibrationsSurgical instruments, devices or methods for removing obstructions in blood vessels, not otherwise provided for
An intravascular lithotripsy system with an angioplasty-like balloon capable of being filled with a fluid, such as including saline that may be mixed or otherwise provided along with other fluid components like contrast as known. The system may include at least one emitter or pair of electrodes for generating a therapy. For example, an energy wave or high-pressure acoustic energy wave within the balloon with fluid inside may provide the therapy. The system also includes a sensor for detecting damage to the balloon, such as a rupture. The system further includes a control module with a processor for receiving information concerning balloon damage or rupture and the capability of preventing the system from energizing the emitters or electrodes once balloon damage or unacceptable degradation or imminent predicted failure is detected.
A61B 17/22 - Implements for squeezing-off ulcers or the like on inner organs of the bodyImplements for scraping-out cavities of body organs, e.g. bonesSurgical instruments, devices or methods for invasive removal or destruction of calculus using mechanical vibrationsSurgical instruments, devices or methods for removing obstructions in blood vessels, not otherwise provided for
A61B 90/00 - Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups , e.g. for luxation treatment or for protecting wound edges
3.
CUTTING OR SCORING BALLOON WITH LITHOTRIPSY ELECTRODES
An intravascular lithotripsy ("IVL") system includes a catheter assembly. The catheter assembly includes an elongate member. The catheter assembly further includes an enclosure formed along at least a portion of the elongate member. The catheter assembly further includes a plurality of electrode pairs disposed along the elongate member. The catheter assembly further includes a scoring or cutting surface disposed at or near a distal end of the enclosure. The IVL system includes an electrode controller configured to deliver one or more energy pulses to a first set of electrode pairs from among the plurality of electrode pairs while preventing energy pulses from being delivered to the one or more other electrode pairs from the among the electrode pairs causing an energy wave to impact the scoring or cutting surface contributing to breakup of an occlusion, the occlusion substantially impedes traversal of the enclosure within the occlusion.
A61B 17/22 - Implements for squeezing-off ulcers or the like on inner organs of the bodyImplements for scraping-out cavities of body organs, e.g. bonesSurgical instruments, devices or methods for invasive removal or destruction of calculus using mechanical vibrationsSurgical instruments, devices or methods for removing obstructions in blood vessels, not otherwise provided for
4.
Conductive band and wire conductor assembly for intravascular lithotripsy
A catheter and segmented balloon system for an intravascular lithotripsy system having improved accommodation for curved configurations to prevent damage to the balloon during electrical arcing of electrode pairs. The catheter can include an elongate member with alternating flexibility regions wherein stiffer regions are configured to support at least one spaced-apart electrode pair, and wherein more flexible regions are disposed on either side of each stiffer region. This configuration allows the elongate member to curve more easily in the region of the electrodes, which are located within a balloon, or segmented balloon system. The balloon can include balloon segments with interposed sections between each of the segmented balloons wherein the outer diameter of an inflated balloon segment is larger than the outer diameter of the interposed section.
A61B 17/22 - Implements for squeezing-off ulcers or the like on inner organs of the bodyImplements for scraping-out cavities of body organs, e.g. bonesSurgical instruments, devices or methods for invasive removal or destruction of calculus using mechanical vibrationsSurgical instruments, devices or methods for removing obstructions in blood vessels, not otherwise provided for
A61B 17/00 - Surgical instruments, devices or methods
7.
INTRAVASCULAR DEVICES AND SYSTEMS WITH ENERGY WAVE DETECTION
Methods for determining energy wave characteristics within an intravascular lithotripsy device. Methods can include inflating a balloon with a conductive medium to an inflated state, generating a high voltage pulse at a high voltage pulse generator and generating an energy wave within the conductive medium. During at least the generation of the energy wave, emitting light from a laser source at a desired wavelength along a first light guide path to be emitted within the balloon, reflecting emitted light within the balloon by an acousto-optic effect of the energy wave, and sensing reflected light at a photodetector by way of a second light guide path and determining energy wave data from the reflected light.
A61B 17/22 - Implements for squeezing-off ulcers or the like on inner organs of the bodyImplements for scraping-out cavities of body organs, e.g. bonesSurgical instruments, devices or methods for invasive removal or destruction of calculus using mechanical vibrationsSurgical instruments, devices or methods for removing obstructions in blood vessels, not otherwise provided for
A61B 17/00 - Surgical instruments, devices or methods
SYSTEMS, DEVICES AND METHODS FOR MONITORING CURRENT IN A ROTATIONAL MEDICAL DEVICE AND LED MONITORING AND DISPLAY ARRAYS FOR ANNUNCIATING CURRENT AND PEAK VALUES OF A MONITORED VARIABLE
Various embodiments of the systems, methods and devices are provided to measure current by placing a current measuring device between an atherectomy device's pump and motor. In addition various embodiments of systems, methods and devices are provided with LED arrays on the atherectomy device handle, or external display, indicating real-time magnitudes of one or more monitored variables and peak value(s) of the monitored variable(s).
Methods and devices for lithotripsy procedures. A lithotripsy balloon catheter includes an elongate catheter shaft, an inflation lumen, a multilayer inflatable balloon in fluid communication with the inflation lumen located toward, or at, a distal section of the elongate catheter shaft, and at least one lithotripsy emitter within the multilayer inflatable balloon capable of generating an acoustic pressure wave within an inflation medium when the multilayer inflatable balloon is inflated. The multilayer inflatable balloon includes a first layer and a second layer having a combined wall thickness. The first layer is made of a first polymer material and the second layer is made of a second polymer material, where the second layer is an inner layer relative to the first layer. The multilayer inflatable balloons in accordance with the present disclosure may exhibit a higher rupture strength as compared to a similar, but monolithic, balloon.
A61B 17/22 - Implements for squeezing-off ulcers or the like on inner organs of the bodyImplements for scraping-out cavities of body organs, e.g. bonesSurgical instruments, devices or methods for invasive removal or destruction of calculus using mechanical vibrationsSurgical instruments, devices or methods for removing obstructions in blood vessels, not otherwise provided for
A61B 17/00 - Surgical instruments, devices or methods
A61B 18/00 - Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
A61B 18/24 - Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibreHand-pieces therefor with a catheter
A61B 18/26 - Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibreHand-pieces therefor for producing a shock wave, e.g. laser lithotripsy
Methods and devices for lithotripsy procedures. A lithotripsy balloon catheter includes an elongate catheter shaft, an inflation lumen, a multilayer inflatable balloon in fluid communication with the inflation lumen located toward, or at, a distal section of the elongate catheter shaft, and at least one lithotripsy emitter within the multilayer inflatable balloon capable of generating an acoustic pressure wave within an inflation medium when the multilayer inflatable balloon is inflated. The multilayer inflatable balloon includes a first layer and a second layer having a combined wall thickness. The first layer is made of a first polymer material and the second layer is made of a second polymer material, where the second layer is an inner layer relative to the first layer. The multilayer inflatable balloons in accordance with the present disclosure may exhibit a higher rupture strength as compared to a similar, but monolithic, balloon.
A61B 17/22 - Implements for squeezing-off ulcers or the like on inner organs of the bodyImplements for scraping-out cavities of body organs, e.g. bonesSurgical instruments, devices or methods for invasive removal or destruction of calculus using mechanical vibrationsSurgical instruments, devices or methods for removing obstructions in blood vessels, not otherwise provided for
A61B 18/26 - Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibreHand-pieces therefor for producing a shock wave, e.g. laser lithotripsy
Intravascular lithotripsy (IVL) devices and fault detection of the electrical circuit including one or more emitters. A balanced current circuit includes a high voltage source, a control, and at least one emitter comprising a pair of electrodes across which a spark is to be generated. In a normal working condition, a closed loop electrical circuit with voltage applied via two conductors and current flowing between them when a spark is established. Under normal conditions, current IC on a first conductor from the control to the emitter is the same as current IR returning on a second conductor from the emitter back to the high voltage source and the circuit is in a balanced state. In a balanced state, there is no indication of current leakage from the circuit. In an unbalanced state, current IR is less that current IC, indicating an imbalance of the circuit that suggests a loss or leakage of a current IF.
A61B 17/22 - Implements for squeezing-off ulcers or the like on inner organs of the bodyImplements for scraping-out cavities of body organs, e.g. bonesSurgical instruments, devices or methods for invasive removal or destruction of calculus using mechanical vibrationsSurgical instruments, devices or methods for removing obstructions in blood vessels, not otherwise provided for
A61B 17/00 - Surgical instruments, devices or methods
14.
HIGH ACOUSTIC ENERGY CATHETER SYSTEM FOR HEART VALVE CALCIUM MODIFICATION
An elongate catheter for providing high energy acoustic waves to a heart valve region of a subject, the catheter system including: an inflatable balloon at a distal portion of the catheter system, the inflatable balloon adapted to traverse a vessel of the subject in a radial retracted configuration to reach a treatment site in the heart valve region and receive fluid to inflate to an expanded configuration at the treatment site; a deflectable distal tip portion distal to the inflatable balloon; an emitter within the inflatable balloon; a conductive pathway for supplying energy to the emitter to produce a spark to generate high energy acoustic waves within fluid inflating the balloon; and a movable control member operatively connected to the distal portion for deflecting the distal tip portion in a direction away from the longitudinal axis of the catheter system.
A61B 17/22 - Implements for squeezing-off ulcers or the like on inner organs of the bodyImplements for scraping-out cavities of body organs, e.g. bonesSurgical instruments, devices or methods for invasive removal or destruction of calculus using mechanical vibrationsSurgical instruments, devices or methods for removing obstructions in blood vessels, not otherwise provided for
15.
SYSTEMS AND METHODS FOR CONTROLLED DELIVERY OF ENERGY BY A CATHETER SYSTEM BASED ON A HEARTBEAT CYCLE
Systems and method are directed to an ability to provide greater control to the firing of IVL emitters based upon feedback data of the heartbeat of a subject patient. Preferably, the feedback data will allow for automated control of the actual high voltage pulse and thus the firing of one or more of the emitters. A specific purpose of controlling the emitter firing is to avoid firing the emitters at time where the heart is more vulnerable to altering the heartbeat of the patient. During a procedure in accordance with one aspect of the present invention, an electro-cardiogram (ECG or EKG) can be used to monitor the heartbeat of the patient. Another aspect is based on a timing of emitter firing based upon whether the particular valve being treated is moving toward the closed position or is in the closed position. Systole and diastole are two phases of the cardiac cycle that occur as the heart beats. Systole occurs when the heart contracts, pumping blood out, while diastole takes place when the heart relaxes after contraction.
A61B 17/22 - Implements for squeezing-off ulcers or the like on inner organs of the bodyImplements for scraping-out cavities of body organs, e.g. bonesSurgical instruments, devices or methods for invasive removal or destruction of calculus using mechanical vibrationsSurgical instruments, devices or methods for removing obstructions in blood vessels, not otherwise provided for
16.
HIGH ACOUSTIC ENERGY CATHETER SYSTEM FOR HEART VALVE CALCIUM MODIFICATION
A system and method for modifying calcifications on a heart valve includes a catheter for providing high energy acoustic waves. The catheter includes a tip portion located distal to an inflatable balloon and the tip portion can include an atraumatic flexible tip for anchoring the catheter and/or deterring movement of the catheter when the catheter is temporarily placed inside a chamber of the heart. The atraumatic flexible tip includes a curved shape at a distal end portion of the tip. A shape and length of the atraumatic flexible tip can be adjusted to accommodate different sized hearts and ventricles within the heart and/or to sufficiently anchor the catheter.
A61B 17/22 - Implements for squeezing-off ulcers or the like on inner organs of the bodyImplements for scraping-out cavities of body organs, e.g. bonesSurgical instruments, devices or methods for invasive removal or destruction of calculus using mechanical vibrationsSurgical instruments, devices or methods for removing obstructions in blood vessels, not otherwise provided for
A61B 17/00 - Surgical instruments, devices or methods
A61B 18/00 - Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
An elongate catheter for providing high energy acoustic waves to a heart valve region of a subject, the catheter system including: an inflatable balloon at a distal portion of the catheter system, the inflatable balloon adapted to traverse a vessel of the subject in a radial retracted configuration to reach a treatment site in the heart valve region and receive fluid to inflate to an expanded configuration at the treatment site; a deflectable distal tip portion distal to the inflatable balloon; an emitter within the inflatable balloon; a conductive pathway for supplying energy to the emitter to produce a spark to generate high energy acoustic waves within fluid inflating the balloon; and a movable control member operatively connected to the distal portion for deflecting the distal tip portion in a direction away from the longitudinal axis of the catheter system.
A61B 17/22 - Implements for squeezing-off ulcers or the like on inner organs of the bodyImplements for scraping-out cavities of body organs, e.g. bonesSurgical instruments, devices or methods for invasive removal or destruction of calculus using mechanical vibrationsSurgical instruments, devices or methods for removing obstructions in blood vessels, not otherwise provided for
A61B 17/00 - Surgical instruments, devices or methods
19.
INTRAVASCULAR LITHOTRIPSY DEVICES AND SYSTEMS WITH FORWARD FACING ELECTRODES AND FLEX CIRCUIT ARRANGEMENTS
A catheter system creates a primarily forward force from forwardly facing electrodes provided within the arrangement of a balloon catheter. The system includes a high voltage pulse generator that provides plus and minus voltage connections with electrode wires. The electrode wires can also pass through a lumen of a catheter toward a distal end of the catheter where they are connected to electrodes preferably arranged in series to create one of more energy waves for propagation toward a thrombus or calcified lesion. Inflation fluid can be injected to balloon as facilitated. The inflation fluid is preferably a saline solution so that it has some level of conductivity.
A61B 17/22 - Implements for squeezing-off ulcers or the like on inner organs of the bodyImplements for scraping-out cavities of body organs, e.g. bonesSurgical instruments, devices or methods for invasive removal or destruction of calculus using mechanical vibrationsSurgical instruments, devices or methods for removing obstructions in blood vessels, not otherwise provided for
A61B 17/00 - Surgical instruments, devices or methods
20.
INTRAVASCULAR LITHOTRIPSY DEVICES WITH THIN-WALLED BALLOONS AND SYSTEMS
Improved IVL systems and components having a reduced tendency for failure caused by undesirable electrical arcing and/or current flow and/or plasma discharge between IVL emitters and a deployed balloon. Additionally, or alternatively, the present invention provides improved IVL systems and components having a reduced tendency for failure caused by possibility of undesirable electrical discharge and/or electrical arcing and/or current flow between the deployed balloon and tissue. This undesirable flow of energy may occur during therapy delivery but may also occur during pauses or at the end of therapy pulses due to a prolonged charging of the fluid solution in the balloon and its effects outside of the balloon.
A61B 17/22 - Implements for squeezing-off ulcers or the like on inner organs of the bodyImplements for scraping-out cavities of body organs, e.g. bonesSurgical instruments, devices or methods for invasive removal or destruction of calculus using mechanical vibrationsSurgical instruments, devices or methods for removing obstructions in blood vessels, not otherwise provided for
A61L 29/14 - Materials characterised by their function or physical properties
Embodiments are disclosed of an intravascular lithotripsy (IVL) catheter. The IVL catheter includes a catheter shaft having a proximal end and a distal end. A balloon is positioned at or near the distal end of the catheter shaft. The balloon has a distal end and a proximal end and includes a distal shoulder at the distal end of the balloon and a proximal shoulder at the proximal end of the balloon. The distal shoulder has a lower shoulder angle than the proximal shoulder. A plurality of spaced-apart emitters are positioned inside the balloon.
A61B 17/22 - Implements for squeezing-off ulcers or the like on inner organs of the bodyImplements for scraping-out cavities of body organs, e.g. bonesSurgical instruments, devices or methods for invasive removal or destruction of calculus using mechanical vibrationsSurgical instruments, devices or methods for removing obstructions in blood vessels, not otherwise provided for
22.
SYSTEMS AND METHODS FOR INTRAVASCULAR LITHOTRIPSY RECOMMENDATIONS
The present disclosure is generally directed to systems and methods including a model trained to determine one or more IVL parameters for preparing lesions within a blood vessel for further treatment. The parameters may be used to configure an IVL system that can prepare the lesions for further treatment. IVL parameters may include, for example, balloon size, balloon diameter, balloon length, balloon pressure, a number of pulses, a number of emitters for a balloon, a shockwave energy distribution for a balloon, a pulse pattern, post-treatment vessel diameter, rime for balloon to be positioned within a vessel, or catheter flexibility, treatment positions, or the like. The model may receive, as input, imaging data of a region of interest. The region of interest may include, for example, one or more lesions to be treated through IVL. In some examples, the imaging data may be intravascular imaging.
A61B 17/22 - Implements for squeezing-off ulcers or the like on inner organs of the bodyImplements for scraping-out cavities of body organs, e.g. bonesSurgical instruments, devices or methods for invasive removal or destruction of calculus using mechanical vibrationsSurgical instruments, devices or methods for removing obstructions in blood vessels, not otherwise provided for
A61B 34/10 - Computer-aided planning, simulation or modelling of surgical operations
G16H 20/40 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
An intravascular lithotripsy (IVL) catheter for treating vessel occlusions comprises a catheter shaft with a longitudinal axis, a balloon capable of inflation and deflation with fluid, and one or more emitters within the balloon's interior. These emitters can emit acoustic waves when the balloon is inflated. The catheter also includes an inner member partially internal to the balloon and wires embedded in the inner member, which are coupled to the emitters and configured to transmit signals to them.
A61B 17/22 - Implements for squeezing-off ulcers or the like on inner organs of the bodyImplements for scraping-out cavities of body organs, e.g. bonesSurgical instruments, devices or methods for invasive removal or destruction of calculus using mechanical vibrationsSurgical instruments, devices or methods for removing obstructions in blood vessels, not otherwise provided for
An IVL catheter comprises (i) a catheter shaft comprising a hypotube comprising a proximal section and a distal section, the distal section defining a skived portion comprising a radially discontinuous hypotube wall, the hypotube comprising an electrically conductive material, the hypotube being operatively connectable to a first terminal of an electrical pulse generator; (ii) one or more emitters connected to the catheter shaft, the one or more emitters being operatively connectable to one or more second terminals of the electrical pulse generator, the one or more emitters being configured for generating pressure waves; and (iii) an enclosure member connected to the catheter shaft, wherein the one or more emitters are disposed within the enclosure member, wherein the skived portion extends into the interior of the enclosure member such that the radially discontinuous hypotube wall is in electrical communication with the one or more emitters.
A61B 17/22 - Implements for squeezing-off ulcers or the like on inner organs of the bodyImplements for scraping-out cavities of body organs, e.g. bonesSurgical instruments, devices or methods for invasive removal or destruction of calculus using mechanical vibrationsSurgical instruments, devices or methods for removing obstructions in blood vessels, not otherwise provided for
25.
DEGASSING SYSTEM FOR INTRAVASCULAR LITHOTRIPSY SYSTEM
Degassing or flushing an IVL catheter balloon. The method includes providing inflation fluid to a catheter balloon from a first fluid reservoir having a positive pressure to inflate the catheter balloon. The method further includes removing at least a portion of the inflation fluid from the catheter balloon to a second fluid reservoir, different from the first fluid reservoir having a negative pressure.
A61B 17/22 - Implements for squeezing-off ulcers or the like on inner organs of the bodyImplements for scraping-out cavities of body organs, e.g. bonesSurgical instruments, devices or methods for invasive removal or destruction of calculus using mechanical vibrationsSurgical instruments, devices or methods for removing obstructions in blood vessels, not otherwise provided for
Systems, devices and methods for generating patterns of voltage pulses and electrical arcs between spaced-apart electrode pairs in intravascular lithotripsy
A pressure wave generating catheter system includes a catheter and a plurality of electrodes disposed within in the catheter. A fluid-fillable balloon encloses the plurality of electrodes. A pulse generator is coupled in electrical communication with the plurality of electrodes in the catheter. The pulse generator is configured to for a given cycle, cause a first voltage pulse to be applied to at least a portion of the plurality of electrodes in the catheter, after which a second voltage pulse is applied to at least a portion of the plurality of electrodes in the catheter, the first voltage pulse causing an initial pressure wave, and wherein the second voltage pulse occurs prior to the initial pressure wave resulting from the first voltage pulse dissipating.
A61B 17/22 - Implements for squeezing-off ulcers or the like on inner organs of the bodyImplements for scraping-out cavities of body organs, e.g. bonesSurgical instruments, devices or methods for invasive removal or destruction of calculus using mechanical vibrationsSurgical instruments, devices or methods for removing obstructions in blood vessels, not otherwise provided for
Atherectomy devices and methods of using such atherectomy devices with automatic control from a control circuit and a number of sensors for advancing an abrasion element, as mounted to a rotational driven shaft and driven from a motor of a handle. If sensors attain threshold values, either above a preset threshold or below a preset threshold, the abrasion element may be retracted by a given distance and then readvanced within the lesion. This can be repeated bases on the sensor readings until the entire lesion is treated. Such threshold values can represent a problem with continued advancement of the abrasion element, such as an imminent stall or other related issues.
A system and method for modifying calcifications on a heart valve includes a dual-function heart valve catheter for performing a cutting operation and an intravascular lithotripsy (IVL) operation. The dual-function heart valve catheter includes an inflatable balloon having a cutting feature on an outer surface of the balloon such that, when the balloon is inflated, the cutting feature cuts or abrades calcification regions on the heart valve. The dual-function heart valve catheter includes first and second electrodes inside the balloon for generating a high voltage pulse from an electrical source, thereby creating a spark through a conductive medium inside the balloon to perform IVL on the calcification regions. The cutting and IVL operations can be repeated as appropriate to effectively treat the calcium legions, including moving and repositioning the catheter within the heart.
A61B 17/22 - Implements for squeezing-off ulcers or the like on inner organs of the bodyImplements for scraping-out cavities of body organs, e.g. bonesSurgical instruments, devices or methods for invasive removal or destruction of calculus using mechanical vibrationsSurgical instruments, devices or methods for removing obstructions in blood vessels, not otherwise provided for
An intravascular lithotripsy (IVL) console is disclosed, comprising a power plug configured to couple to a mains power source, with the power plug extending outside an enclosure housing internal console circuitry. The console includes conductors coupled to the power plug and a first isolation barrier that electrically isolates power from the mains power source. The internal console circuitry includes low-voltage control circuitry and high-voltage power circuitry, which generates high-voltage pulses for emitters in a catheter. A second isolation barrier couples a first processor in the low-voltage control circuitry to a second processor in the high-voltage power circuitry. The second processor receives commands from the first processor and causes the high-voltage power circuitry to deliver high-voltage pulses to the emitters. The isolation barriers allow the power plug to supply power while the high-voltage power circuitry delivers pulses to the emitters.
A61B 17/22 - Implements for squeezing-off ulcers or the like on inner organs of the bodyImplements for scraping-out cavities of body organs, e.g. bonesSurgical instruments, devices or methods for invasive removal or destruction of calculus using mechanical vibrationsSurgical instruments, devices or methods for removing obstructions in blood vessels, not otherwise provided for
A61B 17/00 - Surgical instruments, devices or methods
30.
SYSTEMS, DEVICES AND METHODS FOR GENERATING PATTERNS OF VOLTAGE PULSES AND ELECTRICAL ARCS BETWEEN SPACED-APART ELECTRODE PAIRS IN INTRAVASCULAR LITHOTRIPSY
A catheter system for treating calcific lesions in a patient is disclosed. The system includes an elongated carrier defining a guidewire passageway and an expandable balloon disposed at a distal region of the carrier. The balloon is configured to receive an inflation fluid and encloses a plurality of electrodes arranged to define at least ten electrode gaps capable of electrical arcing. One or more pulse generators are configured to deliver voltage pulses to the electrodes to generate electrical arcs across multiple electrode gaps, thereby producing pressure waves within the fluid. The pressure waves propagate through the balloon and interact with a calcific lesion. The timing of the voltage pulses and the spacing of the electrodes are selected to cause interference between at least two of the pressure waves, enhancing interaction with the lesion.
A61B 17/22 - Implements for squeezing-off ulcers or the like on inner organs of the bodyImplements for scraping-out cavities of body organs, e.g. bonesSurgical instruments, devices or methods for invasive removal or destruction of calculus using mechanical vibrationsSurgical instruments, devices or methods for removing obstructions in blood vessels, not otherwise provided for
A device for creating a pilot hole through lesions in body passageways including an elongated flexible drive shaft advanceable over a guide wire, the drive shaft having a proximal end and a distal end, and a piloting head fixedly attached to at least a portion of the distal end of the driveshaft, wherein the piloting head comprises a distal end having a first diameter, a proximal end having a second diameter that is larger than the first diameter, and an intermediate shoulder area comprising a third diameter that is larger than the first and second diameters, wherein the intermediate shoulder area comprises a radiused crest having a backside area having an abrasive coating, and wherein the diameter of the piloting head tapers down at a generally constant angle from the intermediate shoulder area to the proximal end of the piloting head.
A device for creating a pilot hole through lesions in body passageways including an elongated flexible drive shaft advanceable over a guide wire, the drive shaft having a proximal end and a distal end, and a piloting head fixedly attached to at least a portion of the distal end of the driveshaft, wherein the piloting head comprises a distal end having a first diameter, a proximal end having a second diameter that is larger than the first diameter, and an intermediate shoulder area comprising a third diameter that is larger than the first and second diameters, wherein the intermediate shoulder area comprises a radiused crest having a backside area having an abrasive coating, and wherein the diameter of the piloting head tapers down at a generally constant angle from the intermediate shoulder area to the proximal end of the piloting head.
A61B 17/22 - Implements for squeezing-off ulcers or the like on inner organs of the bodyImplements for scraping-out cavities of body organs, e.g. bonesSurgical instruments, devices or methods for invasive removal or destruction of calculus using mechanical vibrationsSurgical instruments, devices or methods for removing obstructions in blood vessels, not otherwise provided for
33.
CONTROL OF IVL SYSTEMS, DEVICES AND METHODS THEREOF
Various embodiments of the systems, methods, and devices are provided for controlled operation of an intravascular lithotripsy system for breaking up calcified lesions in an anatomical conduit. More specifically, control arrangements are disclosed concerning managing and/or providing electrical energy to generate an electrical arc between a set of spaced-apart electrodes disposed within a fluid-filled member configured to contain a conductive fluid.
A61B 17/00 - Surgical instruments, devices or methods
A61B 17/22 - Implements for squeezing-off ulcers or the like on inner organs of the bodyImplements for scraping-out cavities of body organs, e.g. bonesSurgical instruments, devices or methods for invasive removal or destruction of calculus using mechanical vibrationsSurgical instruments, devices or methods for removing obstructions in blood vessels, not otherwise provided for
A61B 18/00 - Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
G16H 40/63 - ICT specially adapted for the management or administration of healthcare resources or facilitiesICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
H02J 7/00 - Circuit arrangements for charging or depolarising batteries or for supplying loads from batteries
34.
NECESSARY VOLTAGE APPLICATION DURATION FOR INTRAVASCULAR LITHOTRIPSY SYSTEMS, DEVICES AND METHODS
A system, device and/or method to execute intravascular lithotripsy procedures. Some embodiments comprise providing a maximum open gate duration for applying energy in the form of voltage pulses to spaced-apart electrodes that ensures that at least about 95% of the applied voltage pulses result in the generation of electrical arcs between the spaced-apart electrodes. Other embodiments may provide a maximum open gate duration that ensures that at least about 99% of the applied voltage pulses result in the generation of electrical arcs between the spaced-apart electrodes. Still other embodiments may provide a maximum open gate duration that ensures that about 100% of the applied voltage pulses result in the generation of electrical arcs between the spaced-apart electrodes.
A61B 17/22 - Implements for squeezing-off ulcers or the like on inner organs of the bodyImplements for scraping-out cavities of body organs, e.g. bonesSurgical instruments, devices or methods for invasive removal or destruction of calculus using mechanical vibrationsSurgical instruments, devices or methods for removing obstructions in blood vessels, not otherwise provided for
A61B 17/00 - Surgical instruments, devices or methods
35.
Systems, methods and devices for progressively softening multi-compositional intravascular tissue
Various embodiments of the systems, methods and devices are provided comprising angioplasty to break up calcification or other tissue in occlusive areas within a blood vessel. The various embodiments disclosed comprise pressure pulse periods designed to break up calcified occlusive material through a cyclically stretching of the vessel walls without damaging the vessel wall tissue.
A61B 17/00 - Surgical instruments, devices or methods
A61B 17/22 - Implements for squeezing-off ulcers or the like on inner organs of the bodyImplements for scraping-out cavities of body organs, e.g. bonesSurgical instruments, devices or methods for invasive removal or destruction of calculus using mechanical vibrationsSurgical instruments, devices or methods for removing obstructions in blood vessels, not otherwise provided for
A cooling system for a rotational medical device such as a blood pump comprising an electric motor, a rotational drive shaft and an impeller. The cooling system comprises at least one active fluid pump for moving fluid distally within an outer fluid flow channel to a point proximal of the drive shaft's connection with the impeller where the fluid is deflected and urged into a fluidly connected inner fluid flow channel. A portion of the fluid in the outer fluid flow channel is pumped toward the impeller and the remaining fluid flows proximally through the inner fluid flow channel and along the outer surface of the drive shaft, thereby removing frictional heat from the rotating drive shaft. Next, the fluid is urged to bathe the outer surface of the electric motor to remove heat from the motor. Finally, the heated fluid is removed from the system.
A61M 60/802 - Constructional details other than related to driving of non-positive displacement blood pumps
A61M 60/174 - Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient’s body implantable in, on, or around the heart inside a ventricle, e.g. intraventricular balloon pumps discharging the blood to the ventricle or arterial system via a cannula internal to the ventricle or arterial system
A61M 60/216 - Non-positive displacement blood pumps including a rotating member acting on the blood, e.g. impeller
A61M 60/414 - Details relating to driving for non-positive displacement blood pumps the force acting on the blood contacting member being mechanical, e.g. transmitted by a shaft or cable generated by an electromotor transmitted by a rotating cable, e.g. for blood pumps mounted on a catheter
A61M 60/515 - Regulation using real-time patient data
A61M 60/538 - Regulation using real-time blood pump operational parameter data, e.g. motor current
37.
SYSTEMS, DEVICES AND METHODS FOR IVL PROCEDURES WITH IMPROVED EFFICIENCY, EFFECTIVENESS AND SAFETY
A device may include an elongate member; a fluid-fillable enclosure formed of a material and surrounding a distal region of the elongate member; at least one pair of spaced-apart electrodes operatively associated with the elongate member and within the fluid-fillable enclosure. Each pair of the at least one pair of spaced-apart electrodes form a spark gap. A voltage pulse generator is in operative electrical communication and association with the at least one pair of spaced-apart electrodes. A controller in operative association with the voltage pulse generator and configured to control the voltage pulse generator. The device is configured to produce a plurality of electrical arcs across the at least one pair of spaced-apart electrodes, each of the plurality of electrical arcs being produced in response to a voltage pulse provided by the voltage pulse generator. The device is further configured to generate at least one non-arcing voltage pulse.
A61B 17/22 - Implements for squeezing-off ulcers or the like on inner organs of the bodyImplements for scraping-out cavities of body organs, e.g. bonesSurgical instruments, devices or methods for invasive removal or destruction of calculus using mechanical vibrationsSurgical instruments, devices or methods for removing obstructions in blood vessels, not otherwise provided for
A61B 17/00 - Surgical instruments, devices or methods
38.
SYSTEMS, DEVICES AND METHODS FOR IVL PROCEDURES WITH IMPROVED EFFICIENCY, EFFECTIVENESS AND SAFETY
A device may include an elongate member; a fluid-fillable enclosure formed of a material and surrounding a distal region of the elongate member; at least one pair of spaced-apart electrodes operatively associated with the elongate member and within the fluid-fillable enclosure. Each pair of the at least one pair of spaced-apart electrodes form a spark gap. A voltage pulse generator is in operative electrical communication and association with the at least one pair of spaced-apart electrodes. A controller in operative association with the voltage pulse generator and configured to control the voltage pulse generator. The device is configured to produce a plurality of electrical arcs across the at least one pair of spaced-apart electrodes, each of the plurality of electrical arcs being produced in response to a voltage pulse provided by the voltage pulse generator. The device is further configured to generate at least one non-arcing voltage pulse.
A61B 17/22 - Implements for squeezing-off ulcers or the like on inner organs of the bodyImplements for scraping-out cavities of body organs, e.g. bonesSurgical instruments, devices or methods for invasive removal or destruction of calculus using mechanical vibrationsSurgical instruments, devices or methods for removing obstructions in blood vessels, not otherwise provided for
A61B 17/00 - Surgical instruments, devices or methods
39.
BALLOON AND ENERGY TRANSFER DESIGN FOR CALCIUM DISRUPTION
An intravascular lithotripsy ("IVL") catheter system (300) for use in directing energy to tissue of a heart valve may include an energy source (312), a catheter (320), two shafts (320a, 320b) each carrying one or more lithotripsy emitters (322a, 322b), and a balloon (324). The balloon may have an inflated condition with a tubular shape, with the one or more lithotripsy emitters being positioned within the balloon. When inflated, an inner wall of the balloon may defines an inflow end to be positioned adjacent an inflow end of the heart valve, am outflow end to be positioned adjacent an outflow end of the heart valve, and an open interior space (350) to be positioned within the heart valve. The open interior space may allow blood to flow from the inflow end of the balloon to the outflow end of the balloon through the open interior space.
A61B 17/22 - Implements for squeezing-off ulcers or the like on inner organs of the bodyImplements for scraping-out cavities of body organs, e.g. bonesSurgical instruments, devices or methods for invasive removal or destruction of calculus using mechanical vibrationsSurgical instruments, devices or methods for removing obstructions in blood vessels, not otherwise provided for
In some examples, a method of treating a native heart valve includes providing an intravascular lithotripsy having an energy source, a catheter operably coupled to the energy source, a balloon disposed over a portion of the catheter, and at least one lithotripsy emitter coupled to the catheter and having a funnel shape, inflating the balloon within the native heart valve, generating energy from the energy source, and funneling the energy onto a native leaflet or a native aortic annulus via the funnel shape of the at least one lithotripsy emitter while preventing the energy from being dispersed to other regions.
A61B 17/22 - Implements for squeezing-off ulcers or the like on inner organs of the bodyImplements for scraping-out cavities of body organs, e.g. bonesSurgical instruments, devices or methods for invasive removal or destruction of calculus using mechanical vibrationsSurgical instruments, devices or methods for removing obstructions in blood vessels, not otherwise provided for
41.
DEVICES AND METHODS TO CENTER PRESSURE WAVE GENERATORS WITHIN A SEGMENTED BALLOON
A catheter and segmented balloon system for a lithotripsy system having improved accommodation for curved configurations, which minimizes or prevents damage to the balloon during generation of the lithotripsy shock wave (e.g., resulting from electrical arcing of electrode pairs or use of a laser). Embodiments of the catheter include an elongate member with alternating flexibility regions wherein stiffer regions are configured to support at least one lithotripsy emitter, and wherein more flexible regions are disposed on either side of each stiffer region. This configuration minimizes risk that the section with the lithotripsy emitter(s), will tend to bend in a manner that positions the emitter close to the balloon wall. Embodiments of the segmented balloon system include balloon segments with interposed sections between each of the segmented balloons wherein the outer diameter of an inflated balloon segment is larger than the outer diameter of the interposed section.
A61B 17/22 - Implements for squeezing-off ulcers or the like on inner organs of the bodyImplements for scraping-out cavities of body organs, e.g. bonesSurgical instruments, devices or methods for invasive removal or destruction of calculus using mechanical vibrationsSurgical instruments, devices or methods for removing obstructions in blood vessels, not otherwise provided for
A61B 17/00 - Surgical instruments, devices or methods
An intravascular lithotripsy device, comprising: (i) a first wire conductor operatively connectable to a voltage pulse generator, wherein the first wire conductor comprises a first exposed wire portion comprising that forms a first electrode for at least one pair of spaced-apart electrodes; and (ii) a support member, comprising a body comprising conductive material that is partially covered by insulating material, wherein the body defines a first cutout and a first channel in communication with the first cutout, wherein the first cutout defines a second electrode for the at least one pair of spaced-apart electrodes, wherein the first wire conductor is received and secured by the first channel such that the first wire conductor extends along the support member and the first cutout and such that the first electrode is spaced apart from the second electrode to form an arc generating region between the first electrode and the second electrode.
A61B 17/22 - Implements for squeezing-off ulcers or the like on inner organs of the bodyImplements for scraping-out cavities of body organs, e.g. bonesSurgical instruments, devices or methods for invasive removal or destruction of calculus using mechanical vibrationsSurgical instruments, devices or methods for removing obstructions in blood vessels, not otherwise provided for
A catheter and segmented balloon system for a lithotripsy system having improved accommodation for curved configurations, which minimizes or prevents damage to the balloon during generation of the lithotripsy shock wave (e.g., resulting from electrical arcing of electrode pairs or use of a laser). Embodiments of the catheter include an elongate member with alternating flexibility regions wherein stiffer regions are configured to support at least one lithotripsy emitter, and wherein more flexible regions are disposed on either side of each stiffer region. This configuration minimizes risk that the section with the lithotripsy emitter(s), will tend to bend in a manner that positions the emitter close to the balloon wall. Embodiments of the segmented balloon system include balloon segments with interposed sections between each of the segmented balloons wherein the outer diameter of an inflated balloon segment is larger than the outer diameter of the interposed section.
A61B 17/22 - Implements for squeezing-off ulcers or the like on inner organs of the bodyImplements for scraping-out cavities of body organs, e.g. bonesSurgical instruments, devices or methods for invasive removal or destruction of calculus using mechanical vibrationsSurgical instruments, devices or methods for removing obstructions in blood vessels, not otherwise provided for
Medical devices for use in orbital atherectomy featuring an activation mechanism providing the ability to rotate the drive shaft at an alternate speed.
45.
MANAGEMENT OF STORED ANGULAR MOMENTUM IN STALLED INTRAVASCULAR ROTATIONAL DRIVE SHAFTS FOR ATHERECTOMY
A control system for releasing stored rotational energy and angular momentum in a drive shaft with a distally positioned atherectomy tool, wherein the atherectomy tool is stuck within vasculature. The control system is configured to manage the release of the stored energy and angular momentum of the drive shaft safely and predictably.
A61B 17/00 - Surgical instruments, devices or methods
A61B 90/00 - Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups , e.g. for luxation treatment or for protecting wound edges
46.
SYSTEMS, DEVICES AND METHODS FOR DETECTION OF IVL GAS BUILDUP
A system, device and/or method to test an intravascular lithotripsy ("IVL") system for gas buildup resulting from electrical arc generation within an otherwise liquid fluid-filled enclosure. Generally, a voltage pulse of a magnitude that will not result in an electrical arc is issued from a voltage pulse generator to an electrode of at least one emitter located within the balloon. A voltage or current monitor is used to sense the voltage or current dissipation over time and compared with acceptable dissipation parameter(s). If the voltage or current dissipation over time fails to meet the acceptable dissipation parameter(s), then the IVL system may lock out further execution of voltage pulses designed to produce electrical arcs. Further, the IVL system may alert the operator to initiate a manual degassing procedure, or may automatically initiate a degassing procedure.
A61B 17/22 - Implements for squeezing-off ulcers or the like on inner organs of the bodyImplements for scraping-out cavities of body organs, e.g. bonesSurgical instruments, devices or methods for invasive removal or destruction of calculus using mechanical vibrationsSurgical instruments, devices or methods for removing obstructions in blood vessels, not otherwise provided for
47.
HIGH PERFORMANCE BRAID-FREE MICROCATHETERS WITH IMPROVED VASCULATURE AND LESION CROSSABILITY CHARACTERISTICS AND RESPONSE
Embodiments of the disclosed microcatheters comprise an inner tube that extends from a distal tip to a proximal hub. One embodiment of a microcatheter comprises a first inner coil wound around a length of the inner tube, a second middle coil wound around the first coil and in a different winding direction or lay than the winding direction or lay of the first coil, and a third outer coil wound around a proximal portion of the second coil and in a different winding direction or lay than the winding direction or lay of the second coil. In one disclosed embodiment, the first, second and third coils include distal ends that terminate distally together at a common location that is spaced proximally from the distal tip. Gaps in one or more of the first, second or third coils may be provided between groups or sections of wire filars forming the coils to improve flexibility while maintaining sufficient axial force transmission and torque capabilities.
Embodiments of the disclosed microcatheters comprise an inner tube that extends from a distal tip to a proximal hub. The microcatheter comprises a first inner coil wound around a length of the inner tube, a second middle coil wound around the first coil and in a different winding direction than the winding direction of the first coil, and a third outer coil wound around a proximal portion of the second coil and in a different winding direction than the winding direction of the second coil. The first and second coils terminate distally together at a common location that is spaced proximally from the distal tip and the third coil terminates proximally from the termination location of the first and second coils. Gaps may be provided between groups or sections of wire filars forming the coils for flexibility. Outer polymer materials are provided around the coils, wherein the polymers comprise decreasing hardness moving from proximal to distal along the microcatheter.
Various embodiments of the systems, methods, and devices are provided for controlled operation of an intravascular lithotripsy system for breaking up calcified lesions in an anatomical conduit. More specifically, control arrangements are disclosed concerning managing and/or providing and/or terminating provision of electrical energy to generate an electrical arc between a set of spaced-apart electrodes submerged within a contained fluid.
Various embodiments of the systems, methods, and devices are provided for controlled operation of an intravascular lithotripsy system for breaking up calcified lesions in an anatomical conduit. More specifically, control arrangements are disclosed concerning managing and/or providing and/or terminating provision of electrical energy to generate an electrical arc between a set of spaced-apart electrodes submerged within a contained fluid.
A61B 17/22 - Implements for squeezing-off ulcers or the like on inner organs of the bodyImplements for scraping-out cavities of body organs, e.g. bonesSurgical instruments, devices or methods for invasive removal or destruction of calculus using mechanical vibrationsSurgical instruments, devices or methods for removing obstructions in blood vessels, not otherwise provided for
A61B 17/00 - Surgical instruments, devices or methods
G16H 40/63 - ICT specially adapted for the management or administration of healthcare resources or facilitiesICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
51.
Control of IVL systems, devices and methods thereof
A catheter system (100) for treating a vascular lesion (106) within or adjacent to a heart valve (108) within a body (107) of a patient (109), includes an energy source (124), and a plurality of spaced apart treatment devices (143). The energy source (124) generates energy. Each treatment device (143) includes (i) a balloon (104) that is positionable substantially adjacent to the vascular lesion (106), the balloon (104) having a balloon wall (130) that defines a balloon interior (146), the balloon (104) being configured to retain a balloon fluid (132) within the balloon interior (146); and (ii) at least one of a plurality of energy guides (122A) that receive energy from the energy source (124) so that plasma (134) is formed in the balloon fluid (132) within the balloon interior (146).
A61B 17/22 - Implements for squeezing-off ulcers or the like on inner organs of the bodyImplements for scraping-out cavities of body organs, e.g. bonesSurgical instruments, devices or methods for invasive removal or destruction of calculus using mechanical vibrationsSurgical instruments, devices or methods for removing obstructions in blood vessels, not otherwise provided for
A61B 17/00 - Surgical instruments, devices or methods
A61B 18/00 - Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
G16H 40/63 - ICT specially adapted for the management or administration of healthcare resources or facilitiesICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
H02J 7/00 - Circuit arrangements for charging or depolarising batteries or for supplying loads from batteries
Various embodiments of the systems, methods, and devices are provided for controlled operation of an intravascular lithotripsy (“IVL”) system for breaking up calcified lesions in an anatomical conduit. More specifically, control arrangements are disclosed concerning managing and/or providing and/or assessing the electrical energy needed to generate an electrical arc between a set of spaced-apart electrodes disposed within a fluid-fillable member.
A61B 17/22 - Implements for squeezing-off ulcers or the like on inner organs of the bodyImplements for scraping-out cavities of body organs, e.g. bonesSurgical instruments, devices or methods for invasive removal or destruction of calculus using mechanical vibrationsSurgical instruments, devices or methods for removing obstructions in blood vessels, not otherwise provided for
A61B 17/00 - Surgical instruments, devices or methods
53.
CONTROL OF IVL SYSTEMS, DEVICES AND METHODS THEREOF
Various embodiments of the systems, methods, and devices are provided for controlled operation of an intravascular lithotripsy system for breaking up calcified lesions in an anatomical conduit. More specifically, control arrangements are disclosed concerning managing and/or providing electrical energy to generate an electrical arc between a set of spaced-apart electrodes disposed within fluid-fillable member are disclosed.
A61B 17/22 - Implements for squeezing-off ulcers or the like on inner organs of the bodyImplements for scraping-out cavities of body organs, e.g. bonesSurgical instruments, devices or methods for invasive removal or destruction of calculus using mechanical vibrationsSurgical instruments, devices or methods for removing obstructions in blood vessels, not otherwise provided for
H02J 7/00 - Circuit arrangements for charging or depolarising batteries or for supplying loads from batteries
54.
CONTROL OF IVL SYSTEMS, DEVICES AND METHODS THEREOF
Various embodiments of the systems, methods, and devices are provided for controlled operation of an intravascular lithotripsy (“IVL”) system for breaking up calcified lesions in an anatomical conduit. More specifically, control arrangements are disclosed concerning managing and/or providing electrical energy to generate an electrical arc between a set of spaced-apart electrodes disposed within a fluid-fillable member, wherein the IVL system may be powered by an AC power source and/or a DC power source.
A61B 17/22 - Implements for squeezing-off ulcers or the like on inner organs of the bodyImplements for scraping-out cavities of body organs, e.g. bonesSurgical instruments, devices or methods for invasive removal or destruction of calculus using mechanical vibrationsSurgical instruments, devices or methods for removing obstructions in blood vessels, not otherwise provided for
A61B 17/00 - Surgical instruments, devices or methods
55.
CONTROL OF IVL SYSTEMS, DEVICES AND METHODS THEREOF
Various embodiments of the systems, methods, and devices are provided for controlled operation of IVL for breaking up calcified lesions in an anatomical conduit. More specifically, control arrangements are disclosed concerning managing and/or providing electrical energy to generate an electrical arc between a set of spaced-apart electrodes disposed within a fluid-filled balloon, creating stable and constant, or slightly increasing, pressure output over at least 300 voltage pulses. Control arrangements disclosed further determine whether an electrical arc was successfully generated.
A61B 17/22 - Implements for squeezing-off ulcers or the like on inner organs of the bodyImplements for scraping-out cavities of body organs, e.g. bonesSurgical instruments, devices or methods for invasive removal or destruction of calculus using mechanical vibrationsSurgical instruments, devices or methods for removing obstructions in blood vessels, not otherwise provided for
A61B 17/00 - Surgical instruments, devices or methods
56.
INTRAVASCULAR LITHOTRIPSY ALGORITHM FOR IMPROVED BALLOON DURABILITY
Various embodiments of the systems, methods, and devices are provided for controlled operation of IVL for breaking up calcified lesions in an anatomical conduit. More specifically, control arrangements are disclosed concerning managing and/or providing electrical energy to generate an electrical arc between a set of spaced-apart electrodes disposed within a fluid-filled balloon, creating a determined pressure output over several voltage pulses.
A61B 17/22 - Implements for squeezing-off ulcers or the like on inner organs of the bodyImplements for scraping-out cavities of body organs, e.g. bonesSurgical instruments, devices or methods for invasive removal or destruction of calculus using mechanical vibrationsSurgical instruments, devices or methods for removing obstructions in blood vessels, not otherwise provided for
A61B 17/00 - Surgical instruments, devices or methods
G16H 40/63 - ICT specially adapted for the management or administration of healthcare resources or facilitiesICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
57.
INTRAVASCULAR LITHOTRIPSY CATHETER WITH IMPROVED BALLOON DURABILITY
Various embodiments of the systems, methods, and devices are provided for controlled operation of IVL for breaking up calcified lesions in an anatomical conduit. More specifically, control arrangements are disclosed concerning managing and/or providing electrical energy to generate an electrical arc between a set of spaced-apart electrodes disposed within a fluid-filled balloon, creating a determined pressure output over several voltage pulses.
A61B 17/22 - Implements for squeezing-off ulcers or the like on inner organs of the bodyImplements for scraping-out cavities of body organs, e.g. bonesSurgical instruments, devices or methods for invasive removal or destruction of calculus using mechanical vibrationsSurgical instruments, devices or methods for removing obstructions in blood vessels, not otherwise provided for
58.
INTRAVASCULAR LITHOPLASTY SYSTEM WITH IMPROVED DURABILITY, EFFICIENCY AND PRESSURE OUTPUT VARIABILITY
A catheter and segmented balloon system for an intravascular lithotripsy system having improved accommodation for curved configurations to prevent damage to the balloon during electrical arcing of electrode pairs. The catheter can include an elongate member with alternating flexibility regions wherein stiffer regions are configured to support at least one spaced-apart electrode pair, and wherein more flexible regions are disposed on either side of each stiffer region. This configuration allows the elongate member to curve more easily in the region of the electrodes, which are located within a balloon, or segmented balloon system. The balloon can include balloon segments with interposed sections between each of the segmented balloons wherein the outer diameter of an inflated balloon segment is larger than the outer diameter of the interposed section.
A61B 17/22 - Implements for squeezing-off ulcers or the like on inner organs of the bodyImplements for scraping-out cavities of body organs, e.g. bonesSurgical instruments, devices or methods for invasive removal or destruction of calculus using mechanical vibrationsSurgical instruments, devices or methods for removing obstructions in blood vessels, not otherwise provided for
59.
Intravascular Lithoplasty System With Improved Durability, Efficiency and Pressure Output Variability
A catheter and segmented balloon system for an intravascular lithotripsy system having improved accommodation for curved configurations to prevent damage to the balloon during electrical arcing of electrode pairs. The catheter can include an elongate member with alternating flexibility regions wherein stiffer regions are configured to support at least one spaced-apart electrode pair, and wherein more flexible regions are disposed on either side of each stiffer region. This configuration allows the elongate member to curve more easily in the region of the electrodes, which are located within a balloon, or segmented balloon system. The balloon can include balloon segments with interposed sections between each of the segmented balloons wherein the outer diameter of an inflated balloon segment is larger than the outer diameter of the interposed section.
A61B 17/22 - Implements for squeezing-off ulcers or the like on inner organs of the bodyImplements for scraping-out cavities of body organs, e.g. bonesSurgical instruments, devices or methods for invasive removal or destruction of calculus using mechanical vibrationsSurgical instruments, devices or methods for removing obstructions in blood vessels, not otherwise provided for
A61B 17/00 - Surgical instruments, devices or methods
A method of treatment of critical limb ischemia within a foot of a patient and/or critical hand ischemia within a hand of a patient, the method including the steps of delivering a venous reducer by way of the patient's vasculature to a first delivery location within a vein of the foot and/or hand, the venous reducer comprising an expandable structure that when expanded includes an upstream portion and a downstream portion that are connected by a narrowed connection portion, and expanding the venous reducer within the vasculature of the foot and/or hand of the patient and thus creating an hourglass shaped structure within the vasculature where the narrowed connection portion acts as a restriction for blood flow
A61B 17/12 - Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
A61B 17/00 - Surgical instruments, devices or methods
63.
REDUCER FOR CRITICAL LIMB ISCHEMIA AND CRITICAL HAND ISCHEMIA
A method of treatment of critical limb ischemia within a foot of a patient and/or critical hand ischemia within a hand of a patient, the method including the steps of delivering a venous reducer by way of the patient's vasculature to a first delivery location within a vein of the foot and/or hand, the venous reducer comprising an expandable structure that when expanded includes an upstream portion and a downstream portion that are connected by a narrowed connection portion, and expanding the venous reducer within the vasculature of the foot and/or hand of the patient and thus creating an hourglass shaped structure within the vasculature where the narrowed connection portion acts as a restriction for blood flow.
A61B 17/12 - Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
64.
SYSTEMS, METHODS AND DEVICES FOR ADAPTIVE ANGIOPLASTY BALLOON INFLATION AND DEFLATION
Various embodiments of the systems, methods and devices are provided comprising angioplasty to break up calcification or other tissue in occlusive areas within a blood vessel with automated adaptation to volume and/or pressure data that is outside of reaction windows having predetermined boundaries. The various embodiments disclosed comprise pressure pulse periods designed to break up calcified occlusive material through a cyclically stretching of the vessel walls without damaging the vessel wall tissue.
G16H 40/63 - ICT specially adapted for the management or administration of healthcare resources or facilitiesICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
Various embodiments of the systems, methods, and devices are provided for controlled operation of IVL for breaking up calcified lesions in an anatomical conduit. More specifically, control arrangements are disclosed concerning managing and/or providing electrical energy to generate an electrical arc between a set of spaced-apart electrodes disposed within a fluid-filled balloon, creating stable and constant, or slightly increasing, pressure output over at least 300 voltage pulses. Control arrangements disclosed further determine whether an electrical arc was successfully generated.
A61B 17/22 - Implements for squeezing-off ulcers or the like on inner organs of the bodyImplements for scraping-out cavities of body organs, e.g. bonesSurgical instruments, devices or methods for invasive removal or destruction of calculus using mechanical vibrationsSurgical instruments, devices or methods for removing obstructions in blood vessels, not otherwise provided for
A61B 18/00 - Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
Various embodiments of the systems, methods, and devices are provided for controlled operation of IVL for breaking up calcified lesions in an anatomical conduit. More specifically, control arrangements are disclosed concerning managing and/or providing electrical energy to generate an electrical arc between a set of spaced-apart electrodes disposed within a fluid-filled balloon, creating stable and constant, or slightly increasing, pressure output over at least 300 voltage pulses. Control arrangements disclosed further determine whether an electrical arc was successfully generated.
A61B 17/22 - Implements for squeezing-off ulcers or the like on inner organs of the bodyImplements for scraping-out cavities of body organs, e.g. bonesSurgical instruments, devices or methods for invasive removal or destruction of calculus using mechanical vibrationsSurgical instruments, devices or methods for removing obstructions in blood vessels, not otherwise provided for
67.
DRUG COATED BALLOON FOR ANGIOPLASTY SYSTEMS WITH PROGRAMMED INFLATION SEQUENCES AND ADAPTIVE MONITORING CONTROL OF INFLATION SEQUENCES
Various embodiments of the systems, methods and devices are provided comprising drug coated inflatable balloons and balloon catheters. Various embodiments comprise encoded data elements to identify specific balloon and/or catheter parameters or characteristics and, in some cases, to provide specific and customized inflation and deflation sequences for the balloon and catheter in use. Programmed inflation sequences are provided and may also include in some cases adaptive reaction to pressure and/or volume data that is outside of predetermined reaction window(s). The various embodiments disclosed may comprise pressure pulse periods designed to break up calcified occlusive material through a cyclically stretching of the vessel walls without damaging the vessel wall tissue.
Various embodiments of the systems, methods and devices are provided comprising angioplasty to break up calcification or other tissue in occlusive areas within a blood vessel. The various embodiments disclosed comprise pressure pulse periods designed to break up calcified occlusive material through a cyclically stretching of the vessel walls without damaging the vessel wall tissue.
A61B 17/00 - Surgical instruments, devices or methods
A61B 17/22 - Implements for squeezing-off ulcers or the like on inner organs of the bodyImplements for scraping-out cavities of body organs, e.g. bonesSurgical instruments, devices or methods for invasive removal or destruction of calculus using mechanical vibrationsSurgical instruments, devices or methods for removing obstructions in blood vessels, not otherwise provided for
Various embodiments of the systems, methods and devices are provided comprising angioplasty to break up calcification or other tissue in occlusive areas within a blood vessel. The various embodiments disclosed comprise pressure pulse periods designed to break up calcified occlusive material through a cyclically stretching of the vessel walls without damaging the vessel wall tissue.
A61B 17/00 - Surgical instruments, devices or methods
A61B 17/22 - Implements for squeezing-off ulcers or the like on inner organs of the bodyImplements for scraping-out cavities of body organs, e.g. bonesSurgical instruments, devices or methods for invasive removal or destruction of calculus using mechanical vibrationsSurgical instruments, devices or methods for removing obstructions in blood vessels, not otherwise provided for
An intravascular lithotripsy system with an angioplasty-like balloon capable of being filled with a fluid, such as including saline that may be mixed or otherwise provided along with other fluid components like contrast as known. The system may include at least one emitter or pair of electrodes for generating a therapy. For example, an energy wave or high-pressure acoustic energy wave within the balloon with fluid inside may provide the therapy. The system also includes a sensor for detecting damage to the balloon, such as a rupture. The system further includes a control module with a processor for receiving information concerning balloon damage or rupture and the capability of preventing the system from energizing the emitters or electrodes once balloon damage or unacceptable degradation or imminent predicted failure is detected.
A61B 18/24 - Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibreHand-pieces therefor with a catheter
A61B 18/26 - Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibreHand-pieces therefor for producing a shock wave, e.g. laser lithotripsy
71.
INTRAVASCULAR LITHOTRIPSY DEVICES AND SYSTEMS INCLUDING SIZING MEASUREMENT
Systems and methods for performing both an intravascular lithotripsy (IVL) operation and a sizing operation within vasculature of a subject. A system can comprise a catheter having a distal end provided with an inflatable balloon and a plurality of electrodes within the balloon, wherein at least a first electrode is provided as a component of a first emitter and is electrically connected with both a high voltage pulse generator for performing an IVL operation and a conductance excitation module for performing the sizing operation. A method can include exciting a first electrode and sensing conductance or admittance at a second electrode for performing a sizing operation within the balloon as positioned in a vasculature of a subject, and creating a spark between the first electrode, as provided as one electrode component of a first emitter pair of electrodes, and another electrode component of the first emitter pair of electrodes by providing a high voltage pulse from a high voltage pulse generator for performing an IVL operation.
A61B 18/24 - Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibreHand-pieces therefor with a catheter
A61B 18/26 - Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibreHand-pieces therefor for producing a shock wave, e.g. laser lithotripsy
72.
INTRAVASCULAR DEVICES AND SYSTEMS WITH ENERGY WAVE DETECTION
Methods for determining energy wave characteristics within an intravascular lithotripsy device. Methods can include inflating a balloon with a conductive medium to an inflated state, generating a high voltage pulse at a high voltage pulse generator and generating an energy wave within the conductive medium. During at least the generation of the energy wave, emitting light from a laser source at a desired wavelength along a first light guide path to be emitted within the balloon, reflecting emitted light within the balloon by an acousto-optic effect of the energy wave, and sensing reflected light at a photodetector by way of a second light guide path and determining energy wave data from the reflected light.
A61B 18/26 - Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibreHand-pieces therefor for producing a shock wave, e.g. laser lithotripsy
A61B 17/22 - Implements for squeezing-off ulcers or the like on inner organs of the bodyImplements for scraping-out cavities of body organs, e.g. bonesSurgical instruments, devices or methods for invasive removal or destruction of calculus using mechanical vibrationsSurgical instruments, devices or methods for removing obstructions in blood vessels, not otherwise provided for
A61B 18/24 - Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibreHand-pieces therefor with a catheter
The present invention provides an intravascular blood pump and guide wire and guide wire catheter, the blood pump configured to enter the vasculature at one access site and guide wire catheter and guide wire at a second access site separated from the first access site. The guide wire catheter, or the guide wire, comprise a magnet near a distal end and the blood pump's distal tip comprising a magnet, wherein the magnets align and connect within the vasculature within the iliac artery for further advancement as a connected assembly.
A61M 60/13 - Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient’s body implantable via, into, inside, in line, branching on, or around a blood vessel by means of a catheter allowing explantation, e.g. catheter pumps temporarily introduced via the vascular system
A61M 60/17 - Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient’s body implantable in, on, or around the heart inside a ventricle, e.g. intraventricular balloon pumps
A61M 60/237 - Non-positive displacement blood pumps including a rotating member acting on the blood, e.g. impeller the blood flow through the rotating member having mainly axial components, e.g. axial flow pumps
74.
INTRAVASCULAR LITHOTRIPSY DEVICES AND SYSTEMS WITH CURRENT FAULT DETECTION
Intravascular lithotripsy (IVL) devices and fault detection of the electrical circuit including one or more emitters. A balanced current circuit includes a high voltage source, a control, and at least one emitter comprising a pair of electrodes across which a spark is to be generated. In a normal working condition, a closed loop electrical circuit with voltage applied via two conductors and current flowing between them when a spark is established. Under normal conditions, current IC on a first conductor from the control to the emitter is the same as current IR returning on a second conductor from the emitter back to the high voltage source and the circuit is in a balanced state. In a balanced state, there is no indication of current leakage from the circuit. In an unbalanced state, current IR is less that current IC, indicating an imbalance of the circuit that suggests a loss or leakage of a current IF.
A61B 17/22 - Implements for squeezing-off ulcers or the like on inner organs of the bodyImplements for scraping-out cavities of body organs, e.g. bonesSurgical instruments, devices or methods for invasive removal or destruction of calculus using mechanical vibrationsSurgical instruments, devices or methods for removing obstructions in blood vessels, not otherwise provided for
A61B 18/00 - Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
A61B 18/26 - Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibreHand-pieces therefor for producing a shock wave, e.g. laser lithotripsy
75.
Intravascular lithoplasty balloon systems, devices and methods
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 flow and pressure waves. In some embodiments, the electrodes are spaced apart across relatively long distances to create a stronger shock. In some embodiments, the saline ionically conducting between the electrodes is confined to reduce parasitic heating. In some embodiments, the balloon is partially deflated during arc generation.
A61B 17/22 - Implements for squeezing-off ulcers or the like on inner organs of the bodyImplements for scraping-out cavities of body organs, e.g. bonesSurgical instruments, devices or methods for invasive removal or destruction of calculus using mechanical vibrationsSurgical instruments, devices or methods for removing obstructions in blood vessels, not otherwise provided for
A flexible drive shaft assembly is provided for an intravascular medical device, for example and without limitation, a blood pump, a rotational atherectomy device, or a rotational thrombectomy device. The blood pump embodiment provides an electric motor and a rotational impeller, with a rotational drive shaft disposed therebetween and configured to rotationally drive the impeller. The drive shaft is moved from an undeformed length to a deformed length when connected between the electric motor and the rotational impeller to provide a biasing force on the rotational impeller in the proximal direction to maintain the impeller in a desired axial or linear location. In other embodiments, drive shaft comprises a proximal section with a length and a spring constant and a distal section of relatively longer length and a relatively higher spring constant. In other embodiments, hypotube(s) and/or support mandrel(s) may be provided.
Various embodiments of devices and systems comprising a polymer driveshaft for use in high-speed rotational medical procedures, e.g., atherectomy, are disclosed. Generally, the primary driveshaft for transferring torque and activating rotation of a tool attached thereto, e.g., an abrasive element, is constructed with at least a polymer outer and inner surface. In certain embodiments, the polymer driveshaft may comprise a metallic band for fixed attachment of a structure, e.g., an abrasive element, thereto. Various embodiments may comprise a coupler that connects a drive shaft connected with a prime mover, e.g., a turbine or electric motor, with the polymer drive shaft, the coupler comprising openings through the coupler wall to the inner diameter of the coupler to allow fluid flow to the inner diameter of the coupled polymer drive shaft.
A61B 90/00 - Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups , e.g. for luxation treatment or for protecting wound edges
78.
INTRAVASCULAR LITHOTRIPSY DEVICES AND SYSTEMS HAVING SPARK MONITORING FEEDBACK
An intravascular lithotripsy catheter system for use in providing an energy wave a force to a thrombus or lesion within a vasculature, the catheter system including a catheter that extends from a proximal end to a distal end with a saline delivery lumen open from the distal end of the catheter for creating a controlled volume or bolus of saline at a distal region of the catheter, at least one pair of electrodes provided within the distal region of the controlled volume that are connectable with a high voltage pulse generator to create a spark across the electrode pair when inflated with a saline solution, and an optical fiber extending from the proximal end of the catheter distally to a position within the balloon for observing an optical phenomenon within the balloon when detectable light energy is generated by the optical phenomenon. Preferably, the optical fiber is connected with a photosensor at the proximal end of the catheter. Methods of using such a catheter system are also contemplated.
A61B 17/22 - Implements for squeezing-off ulcers or the like on inner organs of the bodyImplements for scraping-out cavities of body organs, e.g. bonesSurgical instruments, devices or methods for invasive removal or destruction of calculus using mechanical vibrationsSurgical instruments, devices or methods for removing obstructions in blood vessels, not otherwise provided for
A61B 17/00 - Surgical instruments, devices or methods
A61B 90/00 - Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups , e.g. for luxation treatment or for protecting wound edges
79.
INTRAVASCULAR LITHOTRIPSY DEVICES AND SYSTEMS HAVING SPARK MONITORING FEEDBACK
An intravascular lithotripsy catheter system for use in providing an energy wave a force to a thrombus or lesion within a vasculature, the catheter system including a catheter that extends from a proximal end to a distal end with a saline delivery lumen open from the distal end of the catheter for creating a controlled volume or bolus of saline at a distal region of the catheter, at least one pair of electrodes provided within the distal region of the controlled volume that are connectable with a high voltage pulse generator to create a spark across the electrode pair when inflated with a saline solution, and an optical fiber extending from the proximal end of the catheter distally to a position within the balloon for observing an optical phenomenon within the balloon when detectable light energy is generated by the optical phenomenon. Preferably, the optical fiber is connected with a photosensor at the proximal end of the catheter. Methods of using such a catheter system are also contemplated.
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 or extensions that allow the electrical arc to form at any one of the plurality of points to, among other things, extend the electrode life.
A61B 17/225 - Surgical instruments, devices or methods for extracorporeal shock wave lithotripsy [ESWL], e.g. by using ultrasonic waves
A61B 17/22 - Implements for squeezing-off ulcers or the like on inner organs of the bodyImplements for scraping-out cavities of body organs, e.g. bonesSurgical instruments, devices or methods for invasive removal or destruction of calculus using mechanical vibrationsSurgical instruments, devices or methods for removing obstructions in blood vessels, not otherwise provided for
81.
CONTROL OF IVL SYSTEMS, DEVICES AND METHODS THEREOF
Various embodiments of the systems, methods, and devices are provided for controlled operation of an intravascular lithotripsy (“IVL”) system for breaking up calcified lesions in an anatomical conduit. More specifically, control arrangements are disclosed concerning managing and/or providing electrical energy to generate an electrical arc between a set of spaced-apart electrodes disposed within a fluid-fillable member, wherein the IVL system may be powered by an AC power source and/or a DC power source.
A61B 17/22 - Implements for squeezing-off ulcers or the like on inner organs of the bodyImplements for scraping-out cavities of body organs, e.g. bonesSurgical instruments, devices or methods for invasive removal or destruction of calculus using mechanical vibrationsSurgical instruments, devices or methods for removing obstructions in blood vessels, not otherwise provided for
A61B 17/00 - Surgical instruments, devices or methods
82.
INTRAVASCULAR LITHOTRIPSY DEVICES WITH THIN-WALLED BALLOONS AND SYSTEMS
Improved IVL systems and components having a reduced tendency for failure caused by undesirable electrical arcing and/or current flow and/or plasma discharge between IVL emitters and a deployed balloon. Additionally, or alternatively, the present invention provides improved IVL systems and components having a reduced tendency for failure caused by possibility of undesirable electrical discharge and/or electrical arcing and/or current flow between the deployed balloon and tissue. This undesirable flow of energy may occur during therapy delivery but may also occur during pauses or at the end of therapy pulses due to a prolonged charging of the fluid solution in the balloon and its effects outside of the balloon.
A61B 17/22 - Implements for squeezing-off ulcers or the like on inner organs of the bodyImplements for scraping-out cavities of body organs, e.g. bonesSurgical instruments, devices or methods for invasive removal or destruction of calculus using mechanical vibrationsSurgical instruments, devices or methods for removing obstructions in blood vessels, not otherwise provided for
83.
CONTROL OF IVL SYSTEMS, DEVICES AND METHODS THEREOF
Various embodiments of the systems, methods, and devices are provided for controlled operation of an intravascular lithotripsy system for breaking up calcified lesions in an anatomical conduit. More specifically, control arrangements are disclosed concerning managing and/or providing electrical energy to generate an electrical arc between a set of spaced-apart electrodes disposed within a fluid-filled member configured to contain a conductive fluid.
A61B 17/22 - Implements for squeezing-off ulcers or the like on inner organs of the bodyImplements for scraping-out cavities of body organs, e.g. bonesSurgical instruments, devices or methods for invasive removal or destruction of calculus using mechanical vibrationsSurgical instruments, devices or methods for removing obstructions in blood vessels, not otherwise provided for
84.
CONTROL OF IVL SYSTEMS, DEVICES AND METHODS THEREOF
Various embodiments of the systems, methods, and devices are provided for controlled operation of an intravascular lithotripsy (“IVL”) system for breaking up calcified lesions in an anatomical conduit. More specifically, control arrangements are disclosed concerning managing and/or providing and/or assessing the electrical energy needed to generate an electrical arc between a set of spaced-apart electrodes disposed within a fluid-fillable member.
A61B 17/22 - Implements for squeezing-off ulcers or the like on inner organs of the bodyImplements for scraping-out cavities of body organs, e.g. bonesSurgical instruments, devices or methods for invasive removal or destruction of calculus using mechanical vibrationsSurgical instruments, devices or methods for removing obstructions in blood vessels, not otherwise provided for
85.
Atherectomy system current sensing, processing and display
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.
Various embodiments of the systems, methods, and devices are provided for controlled operation of an intravascular lithotripsy system for breaking up calcified lesions in an anatomical conduit. More specifically, control arrangements are disclosed concerning managing and/or providing electrical energy to generate an electrical arc between a set of spaced-apart electrodes disposed within fluid-fillable member are disclosed.
A61B 17/22 - Implements for squeezing-off ulcers or the like on inner organs of the bodyImplements for scraping-out cavities of body organs, e.g. bonesSurgical instruments, devices or methods for invasive removal or destruction of calculus using mechanical vibrationsSurgical instruments, devices or methods for removing obstructions in blood vessels, not otherwise provided for
A61B 17/00 - Surgical instruments, devices or methods
87.
INTRAVASCULAR LITHOTRIPSY DEVICES AND SYSTEMS WITH FORWARD FACING ELECTRODES AND FLEX CIRCUIT ARRANGEMENTS
A catheter system creates a primarily forward force from forwardly facing electrodes provided within the arrangement of a balloon catheter. The system includes a high voltage pulse generator that provides plus and minus voltage connections with electrode wires. The electrode wires can also pass through a lumen of a catheter toward a distal end of the catheter where they are connected to electrodes preferably arranged in series to create one of more energy waves for propagation toward a thrombus or calcified lesion. Inflation fluid can be injected to balloon as facilitated. The inflation fluid is preferably a saline solution so that it has some level of conductivity.
A61B 17/22 - Implements for squeezing-off ulcers or the like on inner organs of the bodyImplements for scraping-out cavities of body organs, e.g. bonesSurgical instruments, devices or methods for invasive removal or destruction of calculus using mechanical vibrationsSurgical instruments, devices or methods for removing obstructions in blood vessels, not otherwise provided for
88.
ROTATIONAL DRIVE SHAFTS AND INTRAVASCULAR MEDICAL DEVICES THEREOF
Devices and systems comprising a rotational drive shaft formed of wire filars or one or more coils for use in high-speed rotational medical procedures, e.g., atherectomy, are disclosed. Generally, a preferred embodiment of the drive shaft for transferring torque and activating rotation of a tool such as an abrasive element that is attached near a distal end of the drive shaft may be constructed with a heat shrinkable polymer layer covering at least a middle portion of the drive shaft, wherein a proximal-most portion of the drive shaft is not covered by the heat shrinkable polymer layer. In certain embodiments, the drive shaft may also comprise a distal portion that is not covered by the heat shrinkable layer, most preferably the distal end of the heat shrinkable layer in this embodiment is configured to remain within a delivery catheter or sheath during a medical procedure.
A percutaneous ventricular assist devices, systems and methods are disclosed and provide for a linear guidewire path that does not increase crossing profile and allows the guidewire to take a substantially linear path through the device. The device comprises a rotatable impeller with blades formed from an impeller hub. Notch(es) or apertur(es) are provided through the impeller hub or blade(s) to enable passage of a guidewire therethrough. The impeller blade is rotated to align the notch(es) or aperture(es) with a proximally located stationary guidewire path through a proximal bearing region and/or a proximal housing region. Once the non- stationary guidewire path element is aligned with the stationary guidewire path element, the guidewire may translated along the aligned guidewire path.
A61M 60/13 - Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient’s body implantable via, into, inside, in line, branching on, or around a blood vessel by means of a catheter allowing explantation, e.g. catheter pumps temporarily introduced via the vascular system
A cooling system for a rotational medical device such as a blood pump comprising an electric motor, a rotational drive shaft and an impeller. The cooling system comprises at least one active fluid pump for moving fluid distally within an outer fluid flow channel to a point proximal of the drive shaft's connection with the impeller where the fluid is deflected and urged into a fluidly connected inner fluid flow channel. A portion of the fluid in the outer fluid flow channel is pumped toward the impeller and the remaining fluid flows proximally through the inner fluid flow channel and along the outer surface of the drive shaft, thereby removing frictional heat from the rotating drive shaft. Next, the fluid is urged to bathe the outer surface of the electric motor to remove heat from the motor. Finally, the heated fluid is removed from the system.
A61M 60/414 - Details relating to driving for non-positive displacement blood pumps the force acting on the blood contacting member being mechanical, e.g. transmitted by a shaft or cable generated by an electromotor transmitted by a rotating cable, e.g. for blood pumps mounted on a catheter
A61M 60/13 - Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient’s body implantable via, into, inside, in line, branching on, or around a blood vessel by means of a catheter allowing explantation, e.g. catheter pumps temporarily introduced via the vascular system
A61M 60/80 - Constructional details other than related to driving
A61M 60/90 - Details not provided for in groups , or
A61M 60/216 - Non-positive displacement blood pumps including a rotating member acting on the blood, e.g. impeller
91.
Devices and methods for generating orbital motion in drive shafts for rotational medical devices
Devices, methods and systems are described that enable achieving a working diameter that is greater than a resting diameter and to stimulate fluid circulation during high-speed rotation. The drag coefficient of the drive shaft is increased and, in some embodiments, the mass is increased. Among other advantages, the resulting drive shaft with an eccentric element integrated with and/or attached thereto will achieve orbital motion at a rotational speed that is less the rotational speed required to achieve orbital motion without the increased drag coefficient. The concomitant increase in fluid flow and/or fluid stirring at a comparatively lower rotational speed is a further advantage. These characteristics may allow, therefore, a smaller diameter abrasive element to be used which is advantageous in small and/or highly tortuous vessels.
SYSTEMS, DEVICES AND METHODS FOR MONITORING CURRENT IN A ROTATIONAL MEDICAL DEVICE AND LED MONITORING AND DISPLAY ARRAYS FOR ANNUNCIATING CURRENT AND PEAK VALUES OF A MONITORED VARIABLE
Various embodiments of the systems, methods and devices are provided to measure current by placing a current measuring device between an atherectomy device's pump and motor. In addition various embodiments of systems, methods and devices are provided with LED arrays on the atherectomy device handle, or external display, indicating real-time magnitudes of one or more monitored variables and peak value(s) of the monitored variable(s).
The present invention provides a guidewire assist tool for use in providing a smooth back loading of a guide wire through an intravascular blood pump such as a VAD, LVAD or RVAD. Such devices typically have large apertures or windows, e.g., outlet apertures located proximally of an impeller. The guidewire assist tool temporarily fills the windows to allow the guidewire to smoothly translate past the windows. Once the guidewire tip has translated past the apertures or windows, the guidewire assist tool may be removed.
A61M 60/865 - Devices for guiding or inserting pumps or pumping devices into the patient’s body
A61M 60/178 - Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient’s body implantable in, on, or around the heart drawing blood from a ventricle and returning the blood to the arterial system via a cannula external to the ventricle, e.g. left or right ventricular assist devices
A61M 60/216 - Non-positive displacement blood pumps including a rotating member acting on the blood, e.g. impeller
A guide extension catheter comprising a proximal reinforcing section that is completely surrounded by, or encased within, a polymer covering or coating the proximal reinforcing section, and further comprising an exemplary semi-circular flared section disposed proximal to the proximal reinforcing section, wherein the flare is interrupted by a flattened bottom. The proximal reinforcing section is configured to interconnect with a flat ribbon which is connected with or defines a proximally extending push rod. The proximal reinforcing section does not extend beyond the proximal-most end of the exemplary semi-circular flared section.
Embodiments of the disclosed microcatheters comprise an inner tube that extends from a distal tip to a proximal hub. One embodiment of a microcatheter comprises a first inner coil wound around a length of the inner tube, a second middle coil wound around the first coil and in a different winding direction or lay than the winding direction or lay of the first coil, and a third outer coil wound around a proximal portion of the second coil and in a different winding direction or lay than the winding direction or lay of the second coil. In one disclosed embodiment, the first, second and third coils include distal ends that terminate distally together at a common location that is spaced proximally from the distal tip. Gaps in one or more of the first, second or third coils may be provided between groups or sections of wire filars forming the coils to improve flexibility while maintaining sufficient axial force transmission and torque capabilities.
A guide extension catheter comprising a proximal reinforcing section that is completely surrounded by, or encased within, a polymer covering or coating the proximal reinforcing section, and further comprising an exemplary semi-circular flared section disposed proximal to the proximal reinforcing section, wherein the flare is interrupted by a flattened bottom. The proximal reinforcing section is configured to interconnect with a flat ribbon which is connected with or defines a proximally extending push rod. The proximal reinforcing section does not extend beyond the proximal-most end of the exemplary semi-circular flared section
Embodiments of the disclosed microcatheters comprise an inner tube that extends from a distal tip to a proximal hub. The microcatheter comprises a first inner coil wound around a length of the inner tube, a second middle coil wound around the first coil and in a different winding direction than the winding direction of the first coil, and a third outer coil wound around a proximal portion of the second coil and in a different winding direction than the winding direction of the second coil. The first and second coils terminate distally together at a common location that is spaced proximally from the distal tip and the third coil terminates proximally from the termination location of the first and second coils. Gaps may be provided between groups or sections of wire filars forming the coils for flexibility. Outer polymer materials are provided around the coils, wherein the polymers comprise decreasing hardness moving from proximal to distal along the microcatheter.
A control system for releasing stored rotational energy and angular momentum in a drive shaft with a distally positioned atherectomy tool, wherein the atherectomy tool is stuck within vasculature. The control system is configured to manage the release of the stored energy and angular momentum of the drive shaft safely and predictably.
A61B 17/22 - Implements for squeezing-off ulcers or the like on inner organs of the bodyImplements for scraping-out cavities of body organs, e.g. bonesSurgical instruments, devices or methods for invasive removal or destruction of calculus using mechanical vibrationsSurgical instruments, devices or methods for removing obstructions in blood vessels, not otherwise provided for
