Patent Description:
The statements in this section merely provide background information related to the present disclosure and may or may not constitute prior art.

Lithotripsy is a common method for fragmenting stones, or calculi, in the urinary tract, kidneys, and/or bladder. Most lithotripsy devices use ultrasound, laser, or pneumatic energy sources to fragment such stones. Typically, the lithotripter includes a shaft connected to an electrically controlled driver or a pneumatic actuator. The shaft is inserted into the patient's anatomy to a location near the stone, and a waveform is sent through the shaft to impact the stone with the shaft to create a jackhammer or drilling effect on the stone, thus fragmenting the stone into smaller elements that are easier to remove. The stone fragments are then removed by irrigation and/or baskets.

Among the literature that can pertain to this technology include the following patent documents and published patent applications: <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; and <CIT>. <CIT> and <CIT> disclose ultrasonic devices from the prior art.

Current lithotripsy devices may be expensive, complicated, and/or less effective at fragmenting stones than desired. For example, certain lithotripsy methods may include the use of a first driver to provide a first waveform to the stone through a first shaft and a second driver to provide another waveform to the stone through a second shaft that is concentrically mounted around the first shaft. Though insertion of a lithotripter through the patient's urethra and ureter may be desired, such a device requires percutaneous access to the stone due to the large combined shaft size. In another example, a single driver is used to provide a waveform to the stone, however, the single waveform may not fragment the stone as well as desired.

Accordingly, there exists a need for more effective, simpler, smaller, and/or less expensive lithotripsy devices.

Claim <NUM> defines the invention and dependent claims disclose embodiments. No surgical methods are claimed. The present disclosure provides an improved lithotripter having at least two modes of operation for providing a waveform to a stone in a patient's anatomy, and a shaft to carry the waveform to the stone.

In one aspect, which may be combined with or separate from the other aspects described herein, the present disclosure provides a lithotripter for fragmenting urinary tract stones. The lithotripter includes an ultrasonic driver configured to produce an ultrasonic waveform having an ultrasonic frequency and a sonic driver configured to produce a sonic waveform having a sonic frequency. The sonic driver is mechanically coupled to the ultrasonic driver. The ultrasonic driver and the sonic driver are disposed within a driver housing. A wave guide shaft is provided for transmitting the ultrasonic and sonic waveforms to at least one urinary tract stone. The wave guide shaft is driven by at least one of the ultrasonic driver and the sonic driver.

In another form, which may be combined with or separate from the other forms disclosed herein, a lithotripter for fragmenting urinary tract stones is provided. The lithotripter includes an ultrasonic driver configured to produce an ultrasonic waveform having an ultrasonic frequency and a sonic driver configured to produce a sonic waveform having a sonic frequency. The sonic driver is coupled to the ultrasonic driver. A wave guide shaft is provided for transmitting the ultrasonic and sonic waveforms to at least one urinary tract stone. The wave guide shaft is coupled to at least one of the ultrasonic driver and the sonic driver. The sonic waveform is provided at a frequency that is about equal to a natural frequency of the urinary tract stone.

In yet another form, which may be combined with or separate from the other forms disclosed herein, a method of fragmenting urinary tract stones is provided. The method includes determining a size, determining a type, or determining both a size and type of a urinary tract stone and selecting a magnitude of a sonic frequency for producing a sonic waveform, the magnitude of the sonic frequency being selected based on the size of the urinary tract stone. The method also includes producing the sonic waveform using a sonic driver and producing an ultrasonic waveform having an ultrasonic frequency using an ultrasonic driver. The method further includes transmitting the sonic waveform and the ultrasonic waveform to the urinary tract stone via a wave guide shaft.

In still another form, which may be combined with or separate from the other forms described herein, a lithotripter for fragmenting a stone inside a patient's body is provided. The lithotripter includes a motor having at least two modes of operation. The motor is configured to produce a first waveform and a second waveform. A wave guide shaft is configured to transmit the first and second waveforms to the stone. The motor is configured to provide at least one of the first and second waveforms to the stone at a frequency that is about equal to a natural frequency of the stone.

In still another form, which may be combined with or separate from the other forms described herein, a lithotripter assembly is provided for fragmenting a stone inside a patient's body. The lithotripter includes a brushless DC motor, a mechanical motion converter, and a wave guide shaft. The brushless DC motor is operable to produce a rotational motion. The mechanical motion converter is configured to convert the rotational motion of the brushless DC motor to a linear waveform. The wave guide shaft is configured to transmit the linear waveform to the stone.

Accordingly, pursuant to one aspect of the disclosure, there is contemplated an apparatus comprising one or more of the following: an ultrasonic driver configured to produce an ultrasonic waveform having an ultrasonic frequency; a sonic driver configured to produce a sonic waveform having a sonic frequency, the sonic driver being mechanically coupled to the ultrasonic driver; a driver housing, the ultrasonic driver and the sonic driver being disposed within the driver housing; and a wave guide shaft for transmitting the ultrasonic and sonic waveforms to at least one urinary tract stone, the wave guide shaft being driven by at least one of the ultrasonic driver and the sonic driver.

Accordingly, pursuant to an aspect of the invention, there is contemplated an apparatus comprising one or more of the following: an ultrasonic driver configured to produce an ultrasonic waveform having an ultrasonic frequency; a sonic driver configured to produce a sonic waveform having a sonic frequency, the sonic driver being coupled to the ultrasonic driver; and a wave guide shaft for transmitting the ultrasonic and sonic waveforms to at least one urinary tract stone, the wave guide shaft being coupled to at least one of the ultrasonic driver and the sonic driver; and wherein the sonic waveform is provided at a frequency that is about equal to a natural frequency of the urinary tract stone.

Accordingly, pursuant to yet another aspect of the disclosure, there is contemplated a method comprising one or more of the following steps: determining a size, determining a type, or determining both a size and a type of a urinary tract stone; selecting a magnitude of a sonic frequency for producing a sonic waveform, the magnitude of the sonic frequency being selected based on the size of the urinary tract stone; producing the sonic waveform using a sonic driver; producing an ultrasonic waveform having an ultrasonic frequency using an ultrasonic driver; and transmitting the sonic waveform and the ultrasonic waveform to the urinary tract stone via a wave guide shaft.

Accordingly, pursuant to still another aspect of the present disclosure, there is contemplated an apparatus comprising one or more of the following: a motor having at least two modes of operation, the motor configured to produce a first waveform and a second waveform; and a wave guide shaft configured to transmit the first and second waveforms to the stone; and wherein the motor is configured to provide at least one of the first and second waveforms to the stone at a frequency that is about equal to a natural frequency of the stone.

The disclosure may be further characterized by one or any combination of the features described herein, such as: the sonic driver is an electromagnetic linear driver; the sonic driver is one of a voice coil motor, a moving coil, a moving magnet, and a dual coil; the ultrasonic driver is a piezoelectric stack; the sonic driver is configured to produce the sonic waveform at a sonic frequency that is about equal to a natural frequency of the urinary tract stone; the ultrasonic driver and the sonic driver are disposed in series within the housing; the ultrasonic driver has a proximal end and a distal end; the sonic driver has a proximal end and a distal end; the proximal end of the ultrasonic driver is disposed adjacent to the distal end of the sonic driver; the sonic driver is adjustable to provide the sonic waveform at various frequencies; the sonic driver is adjustable to provide the sonic waveform at a first frequency, a second frequency, and a third frequency, wherein the first frequency is in the range of about <NUM>-<NUM>, the second frequency is in the range of about <NUM>-<NUM>, and the third frequency is in the range of about <NUM>-<NUM>; the ultrasonic driver is configured to provide the ultrasonic waveform at an ultrasonic frequency in the range of about <NUM>-<NUM>; the lithotripter further comprises a closed loop feedback circuit configured to determine a preferred ultrasonic frequency that oscillates at a maximum amplitude; the wave guide shaft is rigid; the wave guide shaft is one of semi-rigid and flexible; the ultrasonic driver is configured to produce the ultrasonic waveform having an ultrasonic waveform amplitude in the range of about <NUM>-<NUM> micrometers; the sonic driver is configured to produce the sonic waveform having a sonic waveform amplitude in the range of about <NUM>-<NUM> millimeters; the wave guide shaft has a shaft length that is configured to deliver the ultrasonic waveform at a maximum amplitude of the ultrasonic waveform; the shaft length is provided in an increment of a half ultrasonic wavelength of the ultrasonic waveform; the lithotripter further comprises first and second springs; the first spring is connected to the proximal end of the sonic driver and a proximal end of the driver housing; the second spring is connected to the distal end of the ultrasonic driver and a distal end of the driver housing; either or both of the proximal and distal springs may also be configured to act in place of a linear bearing, axially supporting and guiding the moving driver elements, thusly providing a linear bearing element function while also providing a necessary mechanical spring element function; the lithotripter has portions forming a lumen therethrough for at least one of suctioning and irrigating a urinary tract; the lithotripter further comprises a stone size detector for detecting the size of the at least one urinary tract stone; the stone size detector comprises at least one of an optical detector and an ultrasonic echo detector; the lithotripter is configured to automatically set the sonic driver to provide the sonic waveform at one of the first, second, and third frequencies based on the size of the at least one urinary tract stone; the lithotripter is configured to set the sonic driver to provide the sonic waveform at the first frequency if the at least one urinary tract stone is greater than about <NUM> millimeters in diameter; the lithotripter is configured to set the sonic driver to provide the sonic waveform at the second frequency if the at least one urinary tract stone is greater than about <NUM>-<NUM> millimeters in diameter and less than or equal to about <NUM> millimeters in diameter; the lithotripter is configured to set the sonic driver to provide the sonic waveform at the third frequency if the at least one urinary tract stone is less than or equal to about <NUM>-<NUM> millimeters in diameter; the ultrasonic driver and the sonic driver are disposed concentrically; the sonic driver has portions forming a cavity therein, the ultrasonic driver being disposed in the cavity of the sonic driver; the lithotripter further comprises a pulsater configured to gate the ultrasonic waveform; the value of the sonic frequency is provided at about the natural frequency of the urinary tract stone; the method further comprises electronic gating the ultrasonic waveform with a square wave of variable frequency and duty cycle consistent with the first, second and third frequencies described above; the lithotripter assembly further comprises a controller configured to operate the brushless DC motor in at least a first mode of operation and a second mode of operation; the first mode of operation is an over-shoot impulse mode and the second mode of operation is a high speed rotational mode; the brushless DC motor has a rotor; in the over-shoot impulse mode, an impulse torque is generated by the brushless DC motor by moving the rotor in a partial rotation; in the high speed rotational mode, the brushless DC motor operates the rotor in a continuous rotational motion; in the over-shoot impulse mode, the rotor is moved in at least one step of less than a full rotation of the rotor to generate a torque on the wave guide shaft; in the over-shoot impulse mode, the rotor in moved in a plurality of back-and-forth steps of between about ten and thirty degrees; the controller is a proportional-integral-derivative (PID) controller; the lithotripter assembly further comprises a position feedback sensor configured to determine the position of the rotor; the position feedback sensor is configured to provide rotor position data to the PID controller; the lithotripter assembly further comprises a housing surrounding the brushless DC motor and the mechanical motion converter; the housing is a handle; the wave guide shaft extends from the handle; the mechanical motion converter comprises a coupler having a cam surface contacting one of: the rotor and an extension connected to the rotor.

Further aspects, advantages and areas of applicability will become apparent from the description provided herein.

The present invention relates to a lithotripter for fragmenting stones.

A lithotripter for fragmenting a stone inside a patient's body is provided. The lithotripter may include a motor (which may have multiple drivers) having at least two modes of operation. The motor is configured to produce a first waveform and a second waveform. A wave guide shaft is configured to transmit the first and second waveforms to the stone. In some forms, at least one of the first and second waveforms is provided to the stone at a frequency that is about equal to a natural frequency of the stone.

With reference to the figures, wherein like numerals indicate like components, and specifically with reference to <FIG>, an example of a lithotripter in accordance with the principles of the present disclosure is illustrated and generally designated at <NUM>. The lithotripter <NUM> may be used for fragmenting stones in a patient's anatomy, such as in a patient's urinary tract, bladder, or kidneys.

The lithotripter <NUM> includes a driver housing <NUM> surrounding an ultrasonic driver <NUM> and a sonic driver <NUM>. Thus, the ultrasonic driver <NUM> and the sonic driver <NUM> are disposed in a cavity <NUM> of the driver housing <NUM>. The ultrasonic driver <NUM> is configured to produce an ultrasonic waveform having an ultrasonic frequency, and the sonic driver <NUM> is configured to produce a sonic waveform having a sonic frequency. Lead wires <NUM> extend from the ultrasonic driver <NUM>, and lead wires <NUM> extend from the sonic driver <NUM>, so that the ultrasonic driver <NUM> and/or the sonic driver <NUM> may be excited by an electrical source (not shown). The sonic driver <NUM> is mechanically coupled to the ultrasonic driver <NUM>, for example, by way of a connector <NUM>. The connector <NUM> provides a rigid connection between the ultrasonic and sonic drivers <NUM>, <NUM>. Herein the sonic driver <NUM> is comprised of the coil <NUM> and the magnet <NUM>. The magnet <NUM> is connected to the ultrasonic driver <NUM> by the connector <NUM>.

A wave guide shaft <NUM> is provided for transmitting the ultrasonic and sonic waveforms to at least one stone, such as a urinary tract stone. For example, the wave guide shaft <NUM> may be partially inserted into the patient through the patient's urethra or percutaneously by way of an incision through the patient's skin, by way of example. One or more waveforms may be delivered to the stone by way of the end <NUM> of the wave guide shaft <NUM>. The wave guide shaft <NUM> is driven by at least one of the ultrasonic driver <NUM> and the sonic driver <NUM>, in this embodiment.

In the present example, the ultrasonic driver <NUM> and the sonic driver <NUM> are disposed in series within the driver housing <NUM>. More specifically, the ultrasonic driver <NUM> has a proximal end <NUM> and a distal end <NUM>, and the sonic driver <NUM> has a proximal end <NUM> and a distal end <NUM>. The proximal end <NUM> of the ultrasonic driver <NUM> is disposed adjacent to the distal end <NUM> of the sonic driver <NUM>. The connector <NUM> contacts and connects the distal end <NUM> of the sonic driver <NUM> and the proximal end <NUM> of the ultrasonic driver <NUM>. Thus, the sonic driver <NUM> is disposed adjacent to a proximal end <NUM> of the driver housing <NUM>, and the ultrasonic driver <NUM> is disposed adjacent to a distal end <NUM> of the driver housing <NUM>.

The sonic driver <NUM> is coupled to the wave guide shaft <NUM> via a linear bearing <NUM>, and the ultrasonic driver <NUM> is coupled to the wave guide shaft <NUM> with a connector <NUM>, and therefore, the wave guide shaft <NUM> also couples the sonic driver <NUM> and the ultrasonic driver <NUM> together. It is contemplated that the linear bearing <NUM> may be made of plastic or other lightweight materials. A first spring <NUM> is connected to the proximal end <NUM> of the sonic driver <NUM> and the proximal end <NUM> of the driver housing <NUM>. A second spring <NUM> is connected to the distal end <NUM> of the ultrasonic driver <NUM> and the distal end <NUM> of the driver housing <NUM>.

The lithotripter <NUM> has portions forming a lumen or channel therethrough for at least one of suctioning and irrigating a urinary tract. For example, the wave guide shaft <NUM> has a lumen <NUM> formed through the center of the wave guide shaft <NUM> and extending along the length of the wave guide shaft <NUM>. In addition, the housing <NUM> has openings <NUM> formed through both the proximal and distal ends <NUM>, <NUM> of the housing <NUM>, the sonic driver <NUM> has a channel <NUM> formed through the center of the sonic driver <NUM>, and the ultrasonic driver <NUM> has a channel <NUM> formed through the center of the ultrasonic driver <NUM>. Accordingly, the wave guide shaft <NUM> extends through the housing <NUM> and the ultrasonic and sonic drivers <NUM>, <NUM>. The wave guide shaft <NUM> may be rigid, semi- rigid, or flexible. Alternatively, rather than continuing uninterrupted through the entire assembly, the waveguide shaft may terminate proximally at or within the distal end <NUM> of the ultrasonic driver <NUM> and, as an integral element of the ultrasonic driver, the central lumen <NUM> may continue therethrough and terminate immediately after exiting the proximal end <NUM> of the ultrasonic driver, as illustrated in <FIG>. The central lumen <NUM> may continue on through the center of the sonic driver <NUM> as an attached tubular addendum to the central lumen at the proximal end <NUM> of the ultrasonic driver and terminate after exiting the proximal end of the housing <NUM> where it may connect to suction tubing for the purposes of removing waste procedural fluids and stone fragments. Tubular addendum <NUM> of the central lumen <NUM> originating with the wave guide shaft <NUM> and continuing through the ultrasonic driver <NUM> may be comprised of an alternate material, such as plastic. The connection between tubular addendum <NUM> of the central lumen and the proximal end <NUM> of ultrasonic driver <NUM> may be configured to limit interference with the ultrasonic vibration of ultrasonic driver <NUM>. Other configurations of the central lumen <NUM> and various connection methods of central lumen components may be utilized to minimize dampening effects on the ultrasonic vibration of the ultrasonic driver <NUM>.

The ultrasonic and sonic drivers <NUM>, <NUM> may take on various forms, without departing from the scope of the present disclosure. For example, the sonic driver <NUM> may be an electromagnetic linear driver. By way of further example, the sonic driver <NUM> may be a voice coil motor, a moving coil, a moving magnet, or a dual coil. The ultrasonic driver <NUM> may have a piezoelectric stack. In the exemplary lithotripter configuration presented in <FIG>, the proximal and distal springs are essential participating elements of the sonic driver's operation, as is the mass of the ultrasonic driver, and will directly affect its operational characteristics. Low friction is an essential element of the sonic driver's efficient operation as the amount of friction opposing the free movement of the sonic driver and by way of connection the ultrasonic driver, will determine the spring force required in the proximal and distal springs to properly control and restore the position of the sonic driver during operation, the power required to drive the sonic motor effectively, and potentially the waste heat energy delivered into the lithotripter assembly and possibly the user's hand.

In some forms, the sonic driver <NUM> is configured to produce the sonic waveform at a frequency that oscillates at a natural frequency, or resonance frequency, of the targeted stone. For example, the sonic driver <NUM> may be configured to produce the sonic waveform at a sonic frequency that is about equal to a natural frequency, or resonance frequency, of the targeted stone.

The sonic driver <NUM> may be adjustable to provide the sonic waveform at various frequencies. For example, the sonic driver <NUM> may be adjustable to provide the sonic waveform at a first frequency, a second frequency, and a third frequency. The first frequency may be in the range of about <NUM>-<NUM>, in the range of about <NUM>-<NUM>, or in the range of about <NUM>-<NUM>, by way of example. The second frequency may be in the range of about <NUM>-<NUM>, or in the range of about <NUM>-<NUM>, by way of example. The third frequency may be in the range of about <NUM>-<NUM>, or in the range of about <NUM>-<NUM>, by way of example. The ultrasonic driver <NUM> may be configured to provide the ultrasonic waveform at an ultrasonic frequency in the range of about <NUM>-<NUM>.

Regarding displacement of the waveforms, the ultrasonic driver <NUM> may be configured to produce a waveform of about <NUM>, or about <NUM>-<NUM>. The sonic driver may be configured to produce a waveform of about <NUM>-<NUM>, which may be varied by the user. For example, in the first frequency, the sonic driver <NUM> may be configured to produce a first waveform magnitude of about <NUM>-<NUM>; in the second frequency, the sonic driver <NUM> may be configured to produce a second waveform magnitude of about <NUM>-<NUM>; and in the third frequency, the sonic driver <NUM> may be configured to produce a third waveform magnitude of about <NUM>.

It is contemplated that the sonic waveform's frequency and/or magnitude may be selected based on the size of the targeted stone. For example, the first frequency and waveform magnitude may be selected for larger stones having a size of about <NUM>-<NUM>; the second frequency and waveform magnitude may be selected for medium sized stones having a size of about <NUM>-<NUM>; and the third frequency and waveform magnitude may be selected for smaller stones having a size of about <NUM>-<NUM>. Though three examples are given, the sonic driver <NUM> may be configured to provide any number of selectable frequencies and magnitudes.

In some variations, the lithotripter <NUM> could include one or more selectors to select between the various modes of the sonic driver <NUM>. For example, the selector(s) could be configured to allow the user to select the first, second, or third frequency and/or the first, second, or third waveform magnitude. The selector could include one or more buttons, and/or a slider for fine tuning the selections. For example, the selector could include a first button for selecting the first frequency range and the first waveform magnitude range, and the first ranges could be further chosen with the use of a slider; likewise, the selector could include a second button for selecting the second frequency range and the second waveform magnitude range, and the second ranges could be further chosen with the use of the same slider or a different slider than the slider used for the first ranges; likewise, the selector could include a third button for selecting the third frequency range and the third waveform magnitude range, and the third ranges could be further chosen with the use of the same slider or a different slider than the slider used for the first and/or second ranges.

The lithotripter <NUM> may further include a stone size, mass, or density detector for detecting the size of a stone. For example, the stone size, mass, or density detector could include an optical detector and/or an ultrasonic echo detector, the lithotripter being configured to automatically set the sonic driver to provide the sonic waveform at one of the first, second, and third frequencies based on the size, mass, or density of stone. The lithotripter <NUM> may be configured to set the sonic driver <NUM> to provide the sonic waveform at the first frequency if the target urinary tract stone is greater than about <NUM> millimeters in diameter; the lithotripter <NUM> could be configured to set the sonic driver <NUM> to provide the sonic waveform at the second frequency if the target urinary tract stone is greater than about <NUM>-<NUM> millimeters in diameter and less than or equal to about <NUM> millimeters in diameter; and the lithotripter <NUM> could be configured to set the sonic driver <NUM> to provide the sonic waveform at the third frequency if the target urinary tract stone is less than or equal to about <NUM>-<NUM> millimeters in diameter, by way of example.

The wave guide shaft <NUM> has a shaft length that is configured to deliver the ultrasonic waveform at a maximum amplitude of the ultrasonic waveform. For example, the shaft length may be provided in an increment of a half ultrasonic wavelength of the ultrasonic waveform, such that the displacement is at the highpoint of the waveform at the distal end <NUM> of the wave guide shaft <NUM>. The maximum amplitude of the ultrasonic waveform may be the amplitude that most optimally results in stone destruction.

Referring now to <FIG>, the lithotripter <NUM> could include a closed loop feedback circuit <NUM> configured to determine a preferred ultrasonic frequency that oscillates at a maximum amplitude, producing an anti-node or loop at the distal end <NUM> of the waveguide shaft <NUM>. For example, the voltage generated by the compression and distension of the piezoelectric element of the ultrasonic driver <NUM> is captured and amplified by an amplifier (AMP) <NUM>. The analog signal from the amplifier (AMP) <NUM> is passed to an analog to digital (A/D) converter <NUM> and converted into a <NUM>-<NUM> bit digital signal. This digital signal is passed to a digital comparator (COMP) <NUM> where it is compared to an incrementing or decrementing reference generated by a microcontroller. The digital value is adjusted relative to the reference and the previously read value and passed to a digital to analog (D/A) converter <NUM>. The analog signal generated by the digital to analog converter (D/A) <NUM> drives a voltage controlled oscillator (VCO) <NUM>, which increases or decreases the frequency accordingly. The output of the voltage controlled oscillator (VCO) <NUM> is amplified by a linear amplifier (AMP) <NUM> that drives the piezoelectric stack of the ultrasonic driver <NUM>. This way the loop is closed. Once the maximum value is detected by the COMP <NUM> and the embedded algorithm, the frequency of the ultrasonic driver <NUM> will be set at its optimum value, for maximum amplitude, which will be delivered to the stone <NUM> via the distal end <NUM> of the wave guide shaft <NUM>.

The lithotripter <NUM> may also include a pulsator <NUM> configured to gate the ultrasonic waveform. Thus, the ultrasonic driver <NUM> can be excited with a continuous signal of about <NUM>-<NUM> or with a gated (interrupted) signal of about <NUM>-<NUM>. The gating waveform is a square waveform with variable frequency (<NUM>-<NUM>) and duty cycle. In some embodiments, the duty cycle is about <NUM>% on, <NUM>% off. In some embodiments, the duty cycle is <NUM>% on, <NUM>% off. It is contemplated that the duty cycle may be in the range of <NUM>-<NUM>% on, <NUM>-<NUM>% off. This allows the application of pulsating ultrasonic energy at a selected frequency and on/off duration. The frequency and duty cycle of the gating signal can be user selectable. It is contemplated that the pulsating ultrasonic frequency may be in phase with the gating signal.

The lithotripter <NUM> could have various modes of operation. For example, the lithotripter <NUM> could be operated in an ultrasonic only mode, such that continuous ultrasonic energy alone is transmitted to the targeted stone <NUM>. The lithotripter <NUM> could be operated in a gated ultrasonic mode, such that the ultrasonic energy is gated with a square wave signal with variable duty cycle and frequency of about <NUM>-<NUM> (consistent with the natural frequency of the targeted stone <NUM>). The lithotripter <NUM> could be operated in an oscillating ultrasonic mode, wherein the continuous ultrasonic energy is pulsated by the sonic driver <NUM> with a displacement of about <NUM>-<NUM> and a frequency about <NUM>-<NUM> (consistent with the natural frequency of the stone <NUM>), depending on the selected range. The lithotripter <NUM> could be operated in an oscillating gated ultrasonic mode, wherein gated ultrasonic energy is pulsated by the sonic driver <NUM> with a displacement of about <NUM>-<NUM> and a frequency about <NUM>-<NUM> (consistent with the natural frequency of the stone), depending on the selected range. The lithotripter <NUM> could be operated in a low frequency impact mode, wherein only the low frequency of the sonic driver <NUM>, of about <NUM>-<NUM>, is transmitted to the target stone <NUM> with low amplitude (<NUM>-<NUM>) and high impact (<NUM>-<NUM> lb. ) of force producing a jackhammer effect, and the ultrasonic driver <NUM> is not used.

The ultrasonic and linear driver of the present disclosure are energized with oscillating frequencies which can be entirely independent or can be synchronized and manipulated in various ways. Energizing the drivers in a synchronized, swept-frequency and gated output method produces very effective results over more continuous and/or single frequency energizing methods. While the ideal ultrasonic resonant frequency is applied, it is interrupted or gated in a continuously variable, repeating way, which may be a low-to-high ramped method in order to provide beneficial lithotripsy results.

In one example, utilizing a frequency at the low end of the ranges to drive a shaft, coupled well with a larger stone (greater than <NUM>, for example) with approximately <NUM>-<NUM> initial force effectively transfers the sonic and gated ultrasonic energy into the body of the stone and often causes the stone to crack into multiple pieces as the shaft tip is driving through the stone. Smaller size stones are broken up more easily with a mid-range frequency drive for both the oscillating low frequency longitudinal translation drive and the gating of the ultrasonic resonance drive of the lithotripsy shaft and with less force, and the smallest stones may be reduced to an easily evacuated size with frequencies at the higher end of the frequency range with little to no applied force. It is contemplated that sweeping through from the lowest to the highest end of the frequency range that is ideally optimized for the type of stone encountered as well as for the size of the largest fragment, at a sweep rate that allows some duration of time in the vicinity of any one frequency or frequency band to allow the energy of that frequency or frequency band to couple into the stone fragments effectively to cause a more efficient stone breaking effect as the stone or stone fragments experience strong ultrasonic and lower frequency oscillatory energy that would match well with a resonance frequency of the stone material and/or that would exploit weaknesses in the structure of the stone.

As stone fragment size reduces, less force may be necessary to break the stone fragments into smaller pieces. The lithotripsy system may be coupled to an evacuation flow, or suction source, and thus it has been seen that small stone fragments may be vacuumed up by the shaft tip and the ultrasonic energy of the shaft tip may subsequently reduce the size of stone fragments too large to enter the inner diameter of the lithotripsy shaft into sizes that can be easily evacuated. It is contemplated that the distal tip of the lithotripsy shaft may be designed to limit fragment size that may enter through the evacuation flow. Features at the distal end along these lines would help limit the occurrence of stones which may get stuck along the exit pathway due to constrictions or sharp direction changes in the outflow path or if the fragments are too large and may easily settle and interfere with the exit of future fragments.

In some forms, the distal end <NUM> of wave guide shaft <NUM> may be placed in contact with the stone <NUM> and having a jackhammer effect on the stone <NUM> when one or more of the drivers <NUM>, <NUM> are activated. However, in other forms, the distal end <NUM> of the wave guide shaft <NUM> may be placed adjacent to, but not touching the stone <NUM>. In some forms, the distal end <NUM> of the wave guide shaft <NUM> may gently touch the stone <NUM>, but without a jackhammer effect, such that the oscillation breaks up the stone <NUM>. Such a gentle contact may be preferred when the wave guide shaft <NUM> oscillates at or near the natural frequency of the stone <NUM>.

Referring now to <FIG>, a variation of a lithotripter is illustrated and generally designated at <NUM>. Like the lithotripter <NUM>, the lithotripter <NUM> includes a driver housing <NUM> surrounding an ultrasonic driver <NUM> and a sonic driver <NUM>. Thus, the ultrasonic driver <NUM> and the sonic driver <NUM> are disposed in a cavity <NUM> of the driver housing <NUM>. The ultrasonic and sonic drivers <NUM>, <NUM> may have the same operation and effect and be of the same type as described above with respect to the ultrasonic and sonic drivers <NUM>, <NUM> of the lithotripter <NUM>, and such discussion from above is herein incorporated by reference in this section. Lead wires <NUM> extend from the ultrasonic driver <NUM>, and lead wires <NUM> extend from the sonic driver <NUM>, so that the ultrasonic driver <NUM> and/or the sonic driver <NUM> may be excited by an electrical source (not shown). The sonic driver <NUM> is mechanically coupled to the ultrasonic driver <NUM>, for example, by way of a connector <NUM>. The connector <NUM> provides a rigid connection between the ultrasonic and sonic drivers <NUM>, <NUM>. Herein the sonic driver <NUM> is comprised of the coil <NUM> and the magnet <NUM>. The magnet <NUM> is connected to the ultrasonic driver <NUM> by the connector <NUM>.

In the present example, the ultrasonic driver <NUM> and the sonic driver <NUM> are disposed concentrically with one another within the driver housing <NUM>. More specifically, the sonic driver <NUM> defines a cavity <NUM> therein, and the ultrasonic driver <NUM> is disposed in the cavity <NUM> of the sonic driver <NUM>. The ultrasonic driver <NUM> has a proximal end <NUM> and a distal end <NUM>, and the sonic driver <NUM> has a proximal end <NUM> and a distal end <NUM>. The proximal end <NUM> of the ultrasonic driver <NUM> is disposed adjacent to the proximal end <NUM> of the sonic driver <NUM> within the cavity <NUM> of the sonic driver <NUM>. The distal end <NUM> of the ultrasonic driver <NUM> is disposed adjacent to the distal end <NUM> of the sonic driver <NUM> within the cavity <NUM> of the sonic driver <NUM>. Thus, the proximal ends <NUM>, <NUM> of the ultrasonic and sonic drivers <NUM>, <NUM> are disposed adjacent to a proximal end <NUM> of the driver housing <NUM>, and the distal ends <NUM>, <NUM> of the ultrasonic and sonic drivers <NUM>, <NUM> are disposed adjacent to a distal end <NUM> of the driver housing <NUM>. The sonic driver may be a magnet <NUM> working with a coil <NUM> or set of coils <NUM>,<NUM>.

The ultrasonic and sonic drivers <NUM>, <NUM> are coupled to the wave guide shaft <NUM> via a linear bearing <NUM>, and the ultrasonic driver <NUM> is coupled to the wave guide shaft <NUM> with a connector <NUM>. It is contemplated that the linear bearing <NUM> may be made of plastic or other lightweight materials. A first spring <NUM> is connected to one or both of the proximal ends <NUM>, <NUM> of the ultrasonic and sonic drivers <NUM>, <NUM>, and the first spring <NUM> is connected to the proximal end <NUM> of the driver housing <NUM>. A second spring <NUM> is connected to one or both of the distal ends <NUM>, <NUM> of the ultrasonic and sonic drivers <NUM>, <NUM>, and the second spring <NUM> is connected to the distal end <NUM> of the driver housing <NUM>. It is contemplated that either or both of the proximal and distal springs <NUM>,<NUM> may also be configured to act in place of a linear bearing, axially supporting and guiding the moving driver elements, thusly providing a linear bearing element function while also providing a necessary mechanical spring element function.

The lithotripter <NUM> has portions forming a lumen or channel therethrough for at least one of suctioning and irrigating a urinary tract. For example, the wave guide shaft <NUM> has a lumen <NUM> formed through the center of the wave guide shaft <NUM> and extending along the length of the wave guide shaft <NUM>. In addition, the housing <NUM> has openings <NUM> formed through both the proximal and distal ends <NUM>, <NUM> of the housing <NUM>, and the ultrasonic and sonic drivers <NUM>, <NUM> have a channel <NUM> formed through the center of the ultrasonic and sonic drivers <NUM>, <NUM>. Accordingly, the wave guide shaft <NUM> extends through the housing <NUM> and the ultrasonic and sonic drivers <NUM>, <NUM>. The wave guide shaft <NUM> may be rigid, semi-rigid, or flexible. Alternatively, rather than continuing uninterrupted through the entire handpiece assembly <NUM>, the waveguide shaft <NUM> may terminate proximally at or within the distal end <NUM>,<NUM> of the ultrasonic driver <NUM> and, as an integral element of the ultrasonic driver <NUM>, the central lumen <NUM> may continue therethrough and terminate immediately after exiting the proximal end <NUM> of the ultrasonic driver, as illustrated in <FIG> and <FIG>. The central lumen <NUM> may continue on through the center of the sonic driver <NUM> as an attached tubular addendum to the central lumen at the proximal end <NUM> of the ultrasonic driver and terminate after exiting the proximal end of the housing <NUM> where it may connect to a suction tubing via suction connector <NUM> for the purposes of removing waste procedural fluids and stone fragments. Tubular addendum of the central lumen <NUM> originating with the wave guide shaft <NUM> and continuing through the ultrasonic driver <NUM> may be comprised of an alternate material, such as plastic. The connection between the tubular addendum of the central lumen <NUM> and the proximal end <NUM> of the ultrasonic driver <NUM> may be configured to limit interference with the ultrasonic vibration of the ultrasonic driver <NUM>. Other configurations of the central lumen <NUM> and various connection methods of central lumen components may be utilized to minimize dampening effects on the ultrasonic vibration of the ultrasonic driver <NUM>.

The rest of the description and operation of the lithotripter <NUM>, which is not described as being different than the lithotripter <NUM> may be applied to the lithotripter <NUM>, and such discussion is herein incorporated by reference into this section. For example, the closed loop feedback circuit of <FIG> may be applied to and used by the lithotripter <NUM> of <FIG>.

Referring now to <FIG>, a method of fragmenting urinary tract stones using a lithotripter as claimed herein, such as the lithotripter <NUM>, <NUM> described above, is illustrated and generally designated at <NUM>. The method <NUM> includes a step <NUM> of determining a size, determining a type, or determining both a size and type of a urinary tract stone <NUM>. The method <NUM> further includes a step <NUM> of selecting a magnitude of a sonic frequency for producing a sonic waveform, the magnitude of the sonic frequency being selected based on the size or type of the urinary tract stone <NUM>. For example, the magnitude of the sonic frequency may be selected to correspond to the natural frequency of the target stone <NUM>. The method <NUM> includes a step <NUM> of producing the sonic waveform using a sonic driver <NUM>, <NUM>. The method <NUM> includes a step <NUM> of producing an ultrasonic waveform having an ultrasonic frequency using an ultrasonic driver <NUM>, <NUM>. The steps <NUM>, <NUM> may be completed simultaneously, if desired, or alternatively, serially. The method <NUM> includes a step <NUM> of transmitting the sonic waveform and the ultrasonic waveform to the urinary tract stone <NUM> via a wave guide shaft <NUM>, <NUM>.

When performing the method <NUM>, the magnitude of the sonic frequency may be provided at about the natural frequency of the urinary tract stone <NUM>. In addition, or in the alternative, the magnitude of the sonic frequency may be selectable from at least a low sonic frequency, a medium sonic frequency, and a high sonic frequency. For example, the low sonic frequency may be provided in the range of about <NUM>-<NUM>, the medium sonic frequency may be provided in the range of about <NUM>-<NUM>, and the high sonic frequency may be provided in the range of about <NUM>-<NUM>. The ultrasonic frequency may be provided in the range of about <NUM>-<NUM>. The ultrasonic waveform may be provided having an ultrasonic waveform amplitude in the range of about <NUM>-<NUM> micrometers, and the sonic waveform may be provided having a sonic waveform amplitude in the range of about <NUM>-<NUM> millimeters.

The method <NUM> may also include suctioning and/or irrigating a urinary tract through a lumen <NUM>, <NUM> extending through the wave guide shaft <NUM>, <NUM> and thus, through channels <NUM>, <NUM>, <NUM> formed in the ultrasonic and sonic drivers <NUM>, <NUM>, <NUM>, <NUM>.

In addition, the method <NUM> may include electronic gating the ultrasonic waveform with a square wave of variable frequency and duty cycle, as described above.

Referring now to <FIG>, a variation of a lithotripter is illustrated and generally designated at <NUM>. The lithotripter <NUM> is configured to fragment a stone in a patient's body, such as in a patient's ureter, kidney, or bladder. The lithotripter <NUM> includes a housing <NUM> having a brushless DC motor <NUM> disposed in the housing <NUM>. The brushless DC motor <NUM> is operable to produce a rotational motion. The brushless DC motor <NUM> may be autoclavable and may have three Hall Effect sensors, by way of example. The motor <NUM> may be mounted into a holder portion <NUM> of the housing, for example, with threading.

A motor shaft <NUM> extends from a rotor of the brushless DC motor <NUM> and is operable to be rotated along a longitudinal axis X of the lithotripter <NUM>. A motor coupler <NUM> is attached to the motor shaft <NUM>, which is also illustrated in <FIG>. For example, as shown in <FIG>, the motor coupler <NUM> is annular and has an extension <NUM> extending from an end face <NUM>. The motor coupler <NUM> may be formed of hard steel.

A probe coupler <NUM> having a cam surface <NUM> is disposed in the housing <NUM> adjacent to the motor coupler <NUM>. The probe coupler <NUM> is also illustrated in <FIG>. For example, the probe coupler has an elongate cylindrical shaft <NUM> extending from an end <NUM>. The end <NUM> has the cam surface <NUM> formed thereon. The probe coupler <NUM> (including the cam surface <NUM>) and the motor coupler <NUM> form a mechanical motion converter, wherein the rotational motion produced by the motor <NUM> is converted to a linear oscillating motion of the probe coupler <NUM>, producing a linear waveform. It is contemplated that the cam surface <NUM> may be sloped to encourage production of a greater shock.

A spring <NUM> biases the probe coupler <NUM> into contact with the motor coupler <NUM>, and when the motor coupler <NUM> is rotated, it slides along the cam surface <NUM> and causes the probe coupler <NUM> to move back and forth along the longitudinal axis X. It is contemplated that the spring <NUM> may further comprise a dampening feature. The extensions <NUM> of the motor coupler <NUM> contact the cam surface <NUM> of the probe coupler <NUM> as the motor coupler <NUM> rotates about a center of the motor coupler <NUM>. The motor coupler <NUM> therefore pushes the probe coupler <NUM> along the longitudinal axis X of the lithotripter <NUM> in one direction along the longitudinal axis, and the spring <NUM> biases the probe coupler <NUM> in the opposite direction along the longitudinal direction X, thereby moving the probe coupler <NUM> in the opposite direction when the extension <NUM> of the motor coupler <NUM> is rotated away from a high portion <NUM> of the cam surface <NUM>. It is contemplated that the cam surface may be sloped to create a greater shock. It is contemplated that the cam surface may be hardened and ground to reduce wear potential. A linear bearing <NUM> may be disposed adjacent to the spring <NUM>, which reduces the friction of linear movement. It is contemplated that linear bearing the <NUM> may be made of plastic or other lightweight materials.

A wave guide shaft <NUM> is coupled to the probe coupler <NUM>. The wave guide shaft <NUM> is configured to transmit the linear waveform to a target stone. For example, when the distal end <NUM> of the wave guide shaft <NUM> is placed into contact with a target stone, it may produce a jackhammer effect thereon. Thus, the housing <NUM> may be a handle and the wave guide shaft <NUM> extends therefrom.

It is contemplated that in some embodiments the motor shaft <NUM> may be separate from a cam shaft <NUM> as depicted in <FIG>. Isolating the motor shaft <NUM> from the cam shaft <NUM> may serve to protect the integrity of the motor over time, as illustrated in <FIG>. It is contemplated that a gear assembly <NUM> would transfer energy from the BLDC motor shaft <NUM> to the cam shaft <NUM>. This gear assembly <NUM> may be in a <NUM>:<NUM> ratio, allowing for amplification of the energy output from the motor. The cam shaft <NUM> may include a dampening mechanism <NUM> at a proximal end, which may include a section of silicone and may be further supported with an internal spring within the section of silicone placed between the cam pair <NUM> and the lithotripsy shaft <NUM>, formed together to surround the cam shaft <NUM> and provide dampening of the vibrational and/or linear motion during operation. It is contemplated that bearings and silicone may be provided at points where the cam shaft <NUM> and motor shaft <NUM> connect into the housing <NUM>. In some embodiments, a motor coupler <NUM> is provided with a motor coupler attachment block <NUM> which allows for the option of swapping out a cam pair <NUM>, which represents the transfer point between motor coupler and shaft coupler, to correct for wear during regular maintenance, for example. The motor coupler <NUM> and the motor coupler attachment block <NUM> may be easily loosened and removed using set screws <NUM> in order to insert a replacement motor coupler <NUM>. It is contemplated that a suction or irrigation capability may be provided through the cam shaft <NUM> as this shaft is located toward a centerline of the device.

<FIG> illustrates a close up view of the motor coupler <NUM> and the probe coupler <NUM>. The motor coupler <NUM> (including end surface <NUM>) is disposed in the housing <NUM> adjacent to the shaft coupler <NUM> (including the cam surface <NUM>). The motor coupler <NUM> is removable and replaceable, in some embodiments, by loosening the set screws <NUM> in the motor coupler attachment block <NUM>. The motor coupler connects to the cam shaft <NUM> and the probe coupler connects to the wave guide shaft <NUM>.

The lithotripter <NUM> may be provided as part of a lithotripter assembly <NUM> that also includes a controller <NUM>, or driver/amplifier (see <FIG>). The controller <NUM> may be configured to operate the brushless DC motor <NUM> in at least a first mode of operation and a second mode of operation. The first mode of operation may be an over-shoot impulse mode and the second mode of operation may be a high speed rotational mode.

For example, the brushless DC motor <NUM> has a rotor coupled to the rotational shaft <NUM>. In the over-shoot impulse mode, an impulse torque is generated by the brushless DC motor by moving the rotor in a partial rotation; the rotor and the rotational shaft <NUM> may be moved in at least one step of less than a full rotation of the rotor to generate a torque on the wave guide shaft <NUM>. In one example, the rotor and rotational shaft <NUM> may be moved in a plurality of back-and-forth steps of between about ten and thirty degrees, or about <NUM> degrees in the over-shoot impulse mode, which provides a high torque on the wave guide shaft <NUM>. In the over-shoot impulse mode, the controller <NUM> works on a current mode and a large amplify gain is applied to the current loop. For example, a current of about <NUM> Amps could be applied to the controller <NUM> for a short period. Accordingly, a high torque can be applied to the stone <NUM> with the over-shoot impulse mode, which can have a ballistic effect on the stone <NUM>. The amplify gain can be programmed to adapt to different size stones, using the feedback loop illustrated in <FIG>.

In the high speed rotational mode, the brushless DC motor <NUM> operates the rotor and rotational shaft <NUM> in a continuous rotational motion. A constant control voltage may be applied to the amplifier of the controller <NUM>, and the motor <NUM> may rotate at a speed of up to about <NUM>,<NUM> rpm or even <NUM>,<NUM> rpm. Therefore, in the high speed rotational mode, the rotor and rotational shaft <NUM> may rotate of speeds of about <NUM>,<NUM> to about <NUM>,<NUM> rpm. In one variation, a voltage of about <NUM>-<NUM> V may be applied to the controller <NUM>, for example, about 5V, in the high speed rotational mode.

Referring to <FIG>, a graph <NUM> illustrates the amplitude of the oscillation of the wave guide shaft <NUM> as a function of time. When the lithotripter <NUM> is in the over-shoot impulse mode, a high amplitude of oscillation is provided for a short period of time, as illustrated by the impulse mode plot line <NUM>. When the lithotripter <NUM> is in the high speed rotational mode, a moderate and continuous amplitude is provided as illustrated by the rotational plot line <NUM>. Plot line <NUM> shows the motion of the motor <NUM> when a small proportional gain is applied in the controller <NUM>.

Referring again to <FIG>, the controller <NUM> may be a proportional-integral-derivative (PID) controller, having a proportional <NUM>, integral <NUM>, and derivative <NUM> control logic. The lithotripter assembly <NUM> may also include a position feedback sensor <NUM>, such as an optical encoder, to determine the position of the rotor of the motor <NUM>. The position feedback sensor <NUM> is configured to provide rotor position data to the PID controller <NUM>. The position sensor may provide the rotor position date to a summation point <NUM> within the PID controller, which then updates the control logic and provides the control logic to a summation point <NUM> and ultimately to the motor <NUM>. A power source <NUM> provides a power input to the controller <NUM>, which may be capable of providing a high power for the over-shoot impulse mode and a lower power for the high speed rotational mode, or vice versa.

Thus, in the over-shoot impulse mode, the motor <NUM> is driven by a high performance servo driver <NUM> in current mode. The position sensor <NUM> is located in the update loop. The loop may be set to repeat at <NUM> intervals, for example. The torque provided may be explained by the following equation: τ = Kp(θ2-θ1) + Kd(ω2-ω1), where τ is the torque provided to the stone <NUM> via the wave guide shaft <NUM>, Kp is the proportional gain, θ2 is the rotor final angular position in one loop, θ1 is the initial rotor angular position in one loop, Kd is the derivative gain, ω2 is the final angular velocity of the rotor in one loop, and ω1 is the initial angular velocity of the rotor in one loop. ω2 = dθ2/dt and ω1 = dθ1/dt.

In some embodiments where the cam shaft <NUM> is positioned along a separate longitudinal axis from a central axis of the motor shaft <NUM> and a gear assembly <NUM> is provided to transfer energy between the cam shaft <NUM> and the motor shaft <NUM>, torque values may range from about <NUM> mNm to about <NUM> mNm for a spur gear with gear ratio <NUM>:<NUM>. Resulting rotational speeds for this embodiment would range from about <NUM> rpm to about <NUM> rpm.

As in the examples above, the oscillation of the wave guide shaft <NUM>, <NUM> may be provided to the stone <NUM> at a frequency that is about equal to the natural frequency of the stone <NUM>.

The natural frequency of the stone may vary based on stone size. It is contemplated that various modes of operation may be employed with the lithotripter described herein. By way of example, three ranges may be provided as described above or may be more generalized as small stone mode, large stone mode, and general mode. Small stone mode may provide oscillation frequencies in the range of <NUM>-<NUM>, for example. Large stone mode may provide oscillation frequencies in the range of <NUM>-<NUM>, for example. General mode may provide oscillation frequencies in the range of <NUM>-<NUM>, for example.

In an automatic mode of operation, the device may start with operation in general mode and then upon detection of a large stone or small stone through use of a sensor, for example, proceed to operate in that mode. If at first a large stone mode is utilized, the device may switch to operation in a small stone mode after a predetermined period of time, such as <NUM> seconds to <NUM> minute, for example.

In another embodiment, a manual mode of operation may be utilized. In this mode, a user may select whether or not to operate in large stone mode, small stone mode, or general mode based on direct observation through the distal tip of an endoscope, for example.

It is further contemplated that the device may be provided with a sharp tip which may facilitate stones maintaining contact with the tip during lithotripsy after use of a suction function to attract a stone to the distal end of the device and may further limit size of outgoing fragments during active lithotripsy and may help to enhance the stone free rate by producing smaller particle sizes which can be removed by suction through the lithotripsy shaft <NUM>. It is contemplated that a tip element passage may be provided with various alternative configurations, including a four point crimped tip with countersunk sections, a four slot angled tip with sloped tab ends, a four slot angled tip with sloped tab ends and one side of the tabs bent in, a tip with two slots cut into opposing sides, a divided tip with an optional insert, and a tip with four slots cut in and two inserts with sloped tab end faces. Examples of such tip elements are provided in <FIG>.

<FIG> illustrate an end and a side view of a distal end of an example embodiment of a tip element which may be provided on wave guide shaft <NUM> at a distal end <NUM>. A crimped tip <NUM> is combined with countersunk sections which extend from the distal end <NUM> toward the proximal end of the wave guide shaft <NUM>.

<FIG> illustrate an alternative embodiment which includes a crimped tip <NUM> provided at the distal end <NUM> of the wave guide shaft <NUM>.

<FIG> illustrate an alternative embodiment which includes four slots <NUM> provided at a distal end and also includes angled tip regions <NUM> at the distal end <NUM> of the wave guide shaft <NUM>. <FIG> illustrate an alternative embodiment which includes sloped tab ends <NUM> as well as bent in portions <NUM>, which add an element of contouring to the distal most region which may provide an additional distribution of sharp surfaces for kidney stones to maintain contact with the distal end <NUM>, of the shaft <NUM>. This embodiment illustrates the tabs bent in at one edge in order to reduce the cross-sectional opening area of the tube to reduce the size of the stone fragments entering the tube, increase the affected area of the stone being fragmented, provide a wedging effect to more effectively split up a stone and reduce the overall size of the stone fragments produced. The inclusion of side slots also improves irrigation and enhances the evacuation of smaller stone debris which might otherwise intervene between the shaft tip and the stone being fragmented and thus reduce the lithotripter's stone fragmenting effectiveness by dampening the direct impact of the lithotripter shaft tip on the stone being fragmented.

<FIG> illustrate an additional alternative embodiment in which an insert <NUM> is placed into slots <NUM> and an angle <NUM> is applied to the distal most region <NUM> of the wave guide shaft <NUM>. This embodiment illustrates the addition of a cross-member in order to reduce the cross-sectional opening area of the tube to reduce the size of the stone fragments entering the tube, increase the affected area of the stone being fragmented and more effectively split up a stone and reduce the overall size of the stone fragments produced. Inclusion of side slots could also improve irrigation and enhance the evacuation of smaller stone debris which might otherwise intervene between the shaft tip and the stone being fragmented and thus reduce the lithotripter's stone fragmenting effectiveness by dampening the direct impact of the lithotripter shaft tip on the stone being fragmented. In this example the insert is wider at the face of the tube than it is down inside the tube, to reduce the possibility of clogging at the tip by providing an ever widening cross-section from the distal face of the shaft tip to the proximal direction of the shaft. Inserts such as this may be brazed or welded to the lithotripsy shaft to secure them in place.

<FIG> illustrate an embodiment where one or more insert slots may be provided with interlocking or retaining features for maintaining a position of the insert in slots <NUM> within the distal tip <NUM> of the lithotripter shaft tip. Interlocking features may include grooves, beveled edges, or tabs and slots. These mechanical retaining features are meant to assist in placement of the inserts as well as augment retention of the inserts in addition to welding or brazing or the like of the inserts to the lithotripsy shaft.

<FIG> illustrate an alternative embodiment in which two inserts <NUM> are placed perpendicularly with respect to each other into slots <NUM> to improve fragmentation effectiveness and further limit kidney stone particle size which may enter the wave guide shaft <NUM> during active suction. Edges of the inserts <NUM> may additionally be provided with sharp surfaces <NUM> for enhancing the ability of stones to maintain contact with the distal end <NUM> as well as fragment stones more effectively. In this embodiment, shaft tabs are additionally provided with an angled tip <NUM> to more effectively engage with the surface of a stone. The inserts may be wedged shaped with a narrower proximal edge to reduce the possibility of clogging.

<FIG> represent an embodiment of inserts with interlocking features of the distal end <NUM> of the waveguide shaft <NUM>. A left insert may be rotated and placed on top of a right insert such that they form a tight immovable fit through the use of interlocking features, in the present example via slots cut into the inserts.

<FIG> represent an alternative embodiment of the distal end <NUM> of the wave guide shaft <NUM> with a crimped tip <NUM>. The crimped tip <NUM> is provided with sharp corners <NUM> and pointed edges <NUM> to enhance the ability of kidney stones to maintain contact to waveguide shaft <NUM> during stone breaking or active suction. A smaller distal opening reduces the size of the evacuated fragments.

Similarly to <FIG> but with a thinner side wall, <FIG> illustrate an alternative embodiment of sharp features which may be provided to the distal end <NUM> to wave guide shaft <NUM>. Four slots <NUM> are cut extending from the distal end <NUM> towards the proximal end and sloping <NUM> and angling <NUM> is provided at the tip ends.

<FIG> show lithotripsy shaft tips which have been modified from a flat terminal face by various beveling or angled cutting methods. <FIG> illustrate simple external, planar beveling of a lithotripsy shaft tip. This type of tip provides sharp points and edges for "digging into" stone surfaces as well as wedging action for splitting stones apart. <FIG> present examples of lithotripsy shaft tip faces which have had multiple, angled cuts made, producing sharp, pyramidal and/or ridged points or edges which would enhance the ability of such tips to "dig in" to a stone surface. In both these examples, a tube tip could be augmented with bending or additional material via brazing, welding or the like prior to the surface modification so that an opening smaller than the original tube's internal diameter may be presented, to limit the size of the stone fragments entering the tube during suction. The type of tip configurations represented in <FIG> are expected to have a lower possibility of inadvertent tissue damage due to direct contact as the pointed elements are more numerous, closely positioned and effectively less aggressive than those examples represented in <FIG>, for example.

The above description is merely exemplary in nature and variations are intended to be within the scope of the invention. For example, variations in the various figures can be combined with each without departing from the scope of the present disclosure.

The preferred embodiment of the present invention has been disclosed. A person of ordinary skill in the art would realize, however, that certain modifications would come within the teachings of this invention.

Any numerical values recited in the above application include ail values from the lower value to the upper value in increments of one unit provided that there is a separation of at least <NUM> units between any lower value and any higher value. As an example, if it is stated that the amount of a component or a value of a process variable such as, for example, temperature, pressure, time and the like is, for example, from <NUM> to <NUM>, preferably from <NUM> to <NUM>, more preferably from <NUM> to <NUM>, it is intended that values such as <NUM> to <NUM>, <NUM> to <NUM>, <NUM> to <NUM>, <NUM> to <NUM> etc. are expressly enumerated in this specification. For values which are less than one, one unit is considered to be <NUM>, <NUM>, <NUM> or <NUM> as appropriate. These are only examples of what is specifically intended and all possible combinations of numerical values between the lowest value and the highest value enumerated are to be considered to be expressly stated in this application in a similar manner.

Unless otherwise stated, all ranges include both endpoints and all numbers between the endpoints, the use of "about" or "approximately" in connection with a range apply to both ends of the range. Thus, "about <NUM> to <NUM>" is intended to cover "about <NUM> to about <NUM>", inclusive of at least the specified endpoints.

The term "consisting essentially of" to describe a combination shall include the elements, ingredients, components or steps identified, and such other elements ingredients, components or steps that do not materially affect the basic and novel characteristics of the combination.

Claim 1:
A lithotripter (<NUM>) system for fragmenting urinary tract stones comprising:
an ultrasonic driver (<NUM>) configured to produce an ultrasonic waveform having an ultrasonic frequency;
a sonic driver (<NUM>) configured to produce a sonic waveform having a sonic frequency, the sonic driver (<NUM>) being mechanically coupled to the ultrasonic driver (<NUM>);
a stone size, mass or density detector for detecting a characteristic of the urinary tract stone, the detector coupled to at least one of the sonic driver (<NUM>) or the ultrasonic driver (<NUM>) to provide a control input based on the characteristic of the urinary tract stone; and
a wave guide shaft (<NUM>) for transmitting the ultrasonic and sonic waveforms to at least one urinary tract stone, the wave guide shaft (<NUM>) being driven by at least one of the ultrasonic driver (<NUM>) and the sonic driver (<NUM>).