Patent Description:
In treating an intraluminal clot to restore patency to a catheter, a clinician typically forces a solution of TPA into a lumen of the catheter proximal of the intraluminal clot using a <NUM>-way stopcock method. The method requires a drawing step of drawing fluid from the lumen of the catheter proximal of the clot with a first syringe, thereby creating a partial vacuum, an injecting step of injecting the solution of TPA into the lumen of the catheter under the vacuum with a second syringe, and a waiting step of waiting up to at least <NUM> minutes for the TPA to act on the intraluminal clot before repeating the foregoing steps. While the <NUM>-way stopcock method can be effective, it can also take over an hour or more to treat an intraluminal clot due to its size, extent of occlusion, and location in the catheter. <CIT> relates to an apparatus for use in a vascular space in a body. <CIT> relates to a catheter for use in a vessel of a body. <CIT> relates to a drug-eluting balloon catheter with the functions of ultrasonic thrombus-breaking drug thrombolysis, thrombus suction and angioplasty. <CIT> relates to a cleaning apparatus for cleaning the interior surface of a channel of a medical instrument including an ultrasonic cleaning device having a cleaning catheter provided with ultrasonic vibrators for separating undesired matter from the interior surface of the channel of the medical instrument by ultrasonic vibration and an ultrasonic oscillator for operating the ultrasonic vibrators.

Disclosed herein are medical systems and methods thereof for ultrasonic decomposition of intraluminal clots that improve upon at least the <NUM>-way stopcock method.

The invention is related to medical systems for ultrasonic decomposition of intraluminal clots as defined in the independent claims <NUM> and <NUM>.

Disclosed herein is a medical system for ultrasonic decomposition of intraluminal clots. The medical system includes, in some embodiments, a stylet. The stylet is configured to insert into a lumen of a catheter. The stylet includes one or more electrical impedance sensors and one or more ultrasound transducers. The one-or-more impedance sensors are in a distal portion of the stylet. The one-or more impedance sensors are configured to detect changes in impedance for identifying intraluminal clots in the catheter. The one-or-more ultrasound transducers are embedded in the distal portion of the stylet. The one-or-more ultrasound transducers are configured for decomposing the intraluminal clots to reestablish patency in the catheter.

In some embodiments, the one-or-more ultrasound transducers form an ultrasound-transducer array embedded along a length of stylet.

In some embodiments, the one-or-more ultrasound transducers form an ultrasound-transducer array embedded around a circumference of the stylet.

In some embodiments, the one-or-more ultrasound transducers are configured for decomposing the intraluminal clots by ultrasonic cavitation of fluid proximate of the intraluminal clots.

In some embodiments, the one-or-more ultrasound transducers are further configured for decomposing the intraluminal clots by ultrasonic agitation of a thrombolytic drug in the fluid proximate the intraluminal clots.

In some embodiments, the one-or-more ultrasound transducers are configured for decomposing the intraluminal clots by direct contact of the intraluminal clots with the stylet while the one-or-more ultrasound transducers are in operation.

In some embodiments, the one-or-more ultrasound transducers are configured to automatically activate upon identification of the intraluminal clots by the changes in impedance in accordance with logic onboard a console to which the stylet is connected in an operable state of the medical system.

Also disclosed herein is another medical system for ultrasonic decomposition of intraluminal clots. The medical system includes, in some embodiments, a stylet and an ultrasound probe. The stylet is configured to insert into a lumen of a catheter. The stylet includes one or more electrical impedance sensors and a resonant section of the stylet. The one-or-more impedance sensors are in a distal portion of the stylet. The one-or-more impedance-sensors are configured to detect changes in impedance for identifying intraluminal clots in the catheter. The resonant section of the stylet is in the distal portion of the stylet distal of the one-or-more impedance sensors. The resonant section of the stylet is configured to resonate with an externally applied ultrasonic frequency for decomposing the intraluminal clots to reestablish patency in the catheter. The ultrasound probe is configured to apply the ultrasonic frequency to the resonant section of the stylet.

In some embodiments, the resonant section of the stylet is configured for decomposing the intraluminal clots by ultrasonic cavitation of fluid proximate of the intraluminal clots when the ultrasonic frequency is applied thereto by the ultrasound probe.

In some embodiments, the resonant section of the stylet is further configured for decomposing the intraluminal clots by ultrasonic agitation of a thrombolytic drug in the fluid proximate the intraluminal clots when the ultrasonic frequency is applied thereto by the ultrasound probe.

In some embodiments, the resonant section of the stylet is configured for decomposing the intraluminal clots by direct contact of the intraluminal clots with the stylet when the ultrasonic frequency is applied thereto by the ultrasound probe.

In some embodiments, the ultrasound probe is configured to automatically activate upon identification of the intraluminal clots by the changes in impedance in accordance with logic onboard a console to which the stylet and ultrasound probe are functionally connected in an operable state of the medical system.

In some embodiments, the ultrasound probe is further configured for ultrasound imaging of the intraluminal clots for characterization thereof.

In some embodiments, the ultrasound probe is further configured for ultrasound imaging of the intraluminal clots for confirming the patency in the catheter after the reestablishing thereof.

Also disclosed herein is a method of medical system for ultrasonic decomposition of intraluminal clots. The method includes a stylet-inserting step, a clot-identifying step, and a clot-decomposing step. The stylet-inserting step includes inserting the stylet into a lumen of a catheter. The clot-identifying step includes identifying an intraluminal clot in the catheter by detecting changes in impedance with one or more electrical impedance sensors in a distal portion of the stylet. The clot-decomposing step includes decomposing the intraluminal clot with ultrasound, thereby reestablishing patency in the catheter.

In some embodiments, the clot-decomposing step further includes decomposing the intraluminal clot by ultrasonic cavitation of fluid proximate of the intraluminal clot.

In some embodiments, the clot-decomposing step further includes decomposing the intraluminal clot by ultrasonic agitation of a thrombolytic drug in the fluid proximate the intraluminal clot.

In some embodiments, the method further includes a drug-injecting step. The drug-injecting step includes injecting the thrombolytic drug into the lumen of the catheter before ultrasonic agitation of the thrombolytic drug in the fluid proximate the intraluminal clot in the clot-decomposing step.

In some embodiments, the clot-decomposing step further includes decomposing the intraluminal clot by direct contact of the intraluminal clot with the stylet while one-or-more ultrasound transducers are in operation.

In some embodiments, decomposing the intraluminal clot with ultrasound includes using ultrasound provided by the one-or-more ultrasound transducers formed into an array of ultrasound transducers embedded in the distal portion of the stylet.

In some embodiments, decomposing the intraluminal clot with ultrasound includes applying an ultrasonic frequency to a resonant section in the distal portion of the stylet with an ultrasound probe.

With respect to "proximal," a "proximal portion" or a "proximal-end portion" of, for example, a catheter includes a portion of the catheter intended to be near a clinician when the catheter is used on a patient. Likewise, a "proximal length" of, for example, the catheter includes a length of the catheter intended to be near the clinician when the catheter is used on the patient. A "proximal end" of, for example, the catheter includes an end of the catheter intended to be near the clinician when the catheter is used on the patient. The proximal portion, the proximal-end portion, or the proximal length of the catheter can include the proximal end of the catheter; however, the proximal portion, the proximal-end portion, or the proximal length of the catheter need not include the proximal end of the catheter. That is, unless context suggests otherwise, the proximal portion, the proximal-end portion, or the proximal length of the catheter is not a terminal portion or terminal length of the catheter.

With respect to "distal," a "distal portion" or a "distal-end portion" of, for example, a catheter includes a portion of the catheter intended to be near or in a patient when the catheter is used on the patient. Likewise, a "distal length" of, for example, the catheter includes a length of the catheter intended to be near or in the patient when the catheter is used on the patient. A "distal end" of, for example, the catheter includes an end of the catheter intended to be near or in the patient when the catheter is used on the patient. The distal portion, the distal-end portion, or the distal length of the catheter can include the distal end of the catheter; however, the distal portion, the distal-end portion, or the distal length of the catheter need not include the distal end of the catheter. That is, unless context suggests otherwise, the distal portion, the distal-end portion, or the distal length of the catheter is not a terminal portion or terminal length of the catheter.

As set forth above, intraluminal clots can occur in lumens of catheters such as PIVCs, PICCs, CVCs, or the like, and such intraluminal clots are commonly treated with thrombolytic drugs such as alteplase using a <NUM>-way stopcock method. While the <NUM>-way stopcock method can be effective, it can also take over an hour or more to treat an intraluminal clot due to its size, extent of occlusion, and location in the catheter. Disclosed herein are medical systems and methods thereof for ultrasonic decomposition of intraluminal clots that improve upon at least the <NUM>-way stopcock method.

<FIG> illustrates a medical system <NUM> for ultrasonic decomposition of intraluminal clots in accordance with some embodiments.

As shown, the medical system <NUM> includes a stylet <NUM>, <NUM>, or <NUM> and, in some embodiments, a console <NUM> to which the stylet <NUM>, <NUM>, or <NUM> is connected in an operable state of the medical system <NUM>. The medical system <NUM> can also include an ultrasound probe <NUM> functionally connected to the console <NUM> in an operable state of the medical system <NUM>. Each of the foregoing components are described in more detail below beginning with the stylets <NUM>, <NUM>, and <NUM>.

<FIG> illustrate distal portions of the stylets <NUM>, <NUM>, and <NUM> of the medical system <NUM>. <FIG> illustrates a distal portion of the stylet <NUM> of the medical system <NUM> including one or more ultrasound transducers <NUM> optionally in an ultrasound-transducer array <NUM> in accordance with some embodiments. <FIG> illustrates the distal portion of the stylet <NUM> of the medical system <NUM> including the one-or-more ultrasound transducers <NUM> optionally in another ultrasound-transducer array <NUM> in accordance with some embodiments. <FIG> illustrates the distal portion of the stylet <NUM> of the medical system <NUM> including a resonant section <NUM> of the stylet <NUM> in accordance with some embodiments.

The stylet <NUM>, <NUM>, or <NUM> is configured to insert into a lumen <NUM> of a catheter <NUM> for identifying any intraluminal clots therein and, if present, ultrasonically decomposing the intraluminal clots. (See <FIG> and <FIG>.

The stylet <NUM>, <NUM>, or <NUM> includes one or more electrical impedance sensors <NUM> such as ring electrodes optionally in an impedance-sensor array <NUM> in the distal portion of the stylet <NUM>, <NUM>, or <NUM>. The one-or-more impedance sensors <NUM> are configured to detect changes in impedance for identifying any intraluminal clots in the catheter <NUM>, and the one-or-more impedance sensors <NUM> can include any number of impedance sensors required for monopolar or multipolar (e.g., bipolar, tetrapolar, etc.) impedance measurements therefor.

The stylet <NUM> or <NUM> includes the one-or-more ultrasound transducers <NUM> optionally in the ultrasound-transducer array <NUM> or <NUM> embedded in the distal portion of the stylet <NUM> or <NUM> distal of the one-or-more impedance sensors <NUM> configured for decomposing any intraluminal clots in the catheter <NUM> and reestablishing patency thereof. <FIG> illustrates the one-or-more ultrasound transducers <NUM> formed into the ultrasound-transducer array <NUM> embedded along a length of the stylet <NUM>, while <FIG> illustrates the one-or-more ultrasound transducers <NUM> formed into the ultrasound-transducer array <NUM> embedded around a circumference of the stylet <NUM>. However, the one-or more ultrasound transducers <NUM> of either the stylet <NUM> or <NUM> can be in any arrangement required for decomposing any intraluminal clots in the catheter <NUM>. Indeed, the one-or-more ultrasound transducers <NUM> can be in the ultrasound-transducer array <NUM> or <NUM> or another arrangement as required for decomposing any intraluminal clots in the catheter <NUM> by ultrasonic cavitation of fluid proximate the intraluminal clots, ultrasonic agitation of a thrombolytic drug (e.g., alteplase) in the fluid proximate the intraluminal clots, direct contact of the intraluminal clots with the stylet <NUM> or <NUM> while the one-or-more ultrasound transducers <NUM> are in operation, or a combination thereof.

As an alternative to the stylet <NUM> or <NUM> including the one-or-more ultrasound-transducers <NUM>, the stylet <NUM> includes the resonant section <NUM> in the distal portion of the stylet <NUM> distal of the one-or-more impedance sensors <NUM> configured for decomposing any intraluminal clots in the catheter <NUM> and reestablishing patency thereof. The resonant section <NUM> of the stylet <NUM> is configured to resonate with an externally applied ultrasonic frequency for decomposing any intraluminal clots in the catheter <NUM>. For example, the ultrasound probe <NUM> can be configured to apply the ultrasonic frequency to the resonant section <NUM> of the stylet <NUM>. Indeed, the resonant section <NUM> of the stylet <NUM> can be configured for decomposing any intraluminal clots by ultrasonic cavitation of fluid proximate the intraluminal clots, ultrasonic agitation of a thrombolytic drug in the fluid proximate the intraluminal clots, direct contact of the intraluminal clots with the stylet <NUM>, or the like when the ultrasonic frequency is applied to the resonant section <NUM> of the stylet <NUM> by the ultrasound probe <NUM>.

<FIG> illustrates a block diagram of the medical system in accordance with some embodiments.

As set forth above, the medical system <NUM> includes the stylet <NUM>, <NUM>, or <NUM>, the optional ultrasound probe <NUM>, and, in some embodiments, the console <NUM> to which the stylet <NUM>, <NUM>, or <NUM> and, when present, the ultrasound probe <NUM> are functionally connected in an operable state of the medical system <NUM>. When the ultrasound probe <NUM> is present and functionally connected to the console <NUM>, the medical system <NUM> is configured for ultrasound imaging of any intraluminal clots in the catheter <NUM> for characterization thereof. Advantageously, such a medical system can be used for confirming patency of the catheter <NUM> by ultrasound imaging after decomposing any intraluminal clots in the catheter <NUM> and reestablishing the patency thereof.

The console <NUM> houses and accommodates a variety of components of the medical system <NUM>, and it is appreciated the console <NUM> can take any of a variety of forms. A processor <NUM> and memory <NUM> such as random-access memory ("RAM") or non-volatile memory (e.g., electrically erasable programmable read-only memory ["EEPROM"]) is included in the console <NUM> for controlling functions of the medical system <NUM>, as well as executing various logic operations or algorithms during operation of the medical system <NUM> in accordance executable instructions <NUM> therefor stored in the memory <NUM> for execution by the processor <NUM>. For example, the console <NUM> is configured to instantiate by way of the instructions <NUM> one or more processes for identifying or decomposing any intraluminal clots in the catheter <NUM>, as well as process electrical signals from the ultrasound probe <NUM> into ultrasound images for the ultrasound imaging. A digital controller/analog interface <NUM> is also included with the console <NUM> and is in communication with both the processor <NUM> and other system components to govern interfacing between the ultrasound probe <NUM> and other system components set forth herein.

The console <NUM> further includes ports <NUM> for connection with additional components such as the stylet <NUM>, <NUM>, or <NUM> and optional components <NUM> including a printer, storage media, keyboard, etc. The ports <NUM> can be universal serial bus ("USB") ports, though other types of ports can be used for this connection or any other connections shown or described herein. A power connection <NUM> is included with the console <NUM> to enable operable connection to an external power supply <NUM>. An internal power supply <NUM> (e.g., a battery) can also be employed either with or exclusive of the external power supply <NUM>. Power management circuitry <NUM> is included with the digital controller/analog interface <NUM> of the console <NUM> to regulate power use and distribution.

A display screen <NUM> (e.g., a liquid-crystal display ["LCD"] screen) is integrated into the console <NUM> to provide a GUI and display information for a clinician during such as ultrasound images of intraluminal clots attained by the ultrasound probe <NUM>. Alternatively, the display screen <NUM> is separate from the console <NUM> and communicatively coupled thereto. A console button interface <NUM> and control buttons included on the ultrasound probe <NUM> can be used to immediately call up a desired mode to the display screen <NUM> by the clinician for identifying or decomposing any intraluminal clots in the catheter <NUM>.

The ultrasound probe <NUM> includes a probe head <NUM> that houses an array of ultrasound transducers <NUM>, wherein the ultrasound transducers <NUM> are piezoelectric transducers or capacitive micromachined ultrasound transducers ("CMUTs"). The probe head <NUM> is configured for placement against skin of a patient over the catheter <NUM>. In this way, the medical system <NUM>, by way of the ultrasound probe <NUM> and logic <NUM>, is able to characterize any intraluminal clots in the catheter <NUM> or confirm the patency of the catheter <NUM> by ultrasound imaging. Advantageously, the medical system <NUM> can be configured to automatically activate the one-or more ultrasound transducers <NUM> upon identification of any intraluminal clots by changes in impedance in accordance with the logic <NUM> onboard the console <NUM>.

The ultrasound probe <NUM> also includes a button-and-memory controller <NUM> for governing button operation, as well as governing operation of the ultrasound probe <NUM>. The button-and-memory controller <NUM> can include non-volatile memory (e.g., electrically erasable, programmable read-only memory ["EEPROM"]). The button-and-memory controller <NUM> is in operable communication with a probe interface <NUM> of the console <NUM>, which includes an input/output ("VO") component <NUM> for interfacing with the ultrasound transducers <NUM> and a button-and-memory I/O component <NUM> for interfacing with the button-and-memory controller <NUM>.

<FIG> illustrates decomposing an intraluminal clot to reestablish patency in the catheter <NUM> with the one-or more ultrasound transducer <NUM> optionally in the ultrasound-transducer array <NUM> or <NUM> of the stylet <NUM> or <NUM> in accordance with some embodiments. <FIG> illustrates decomposing an intraluminal clot to reestablish patency in the catheter <NUM> with the resonant section <NUM> of the stylet <NUM> in accordance with some embodiments.

Methods of the medical systems set forth above include methods of using the medical systems. For example, a method of using the medical system <NUM> for ultrasonically decomposing intraluminal clots includes an optional stylet-connecting step, a stylet-inserting step, a clot-identifying step, and a clot-decomposing step.

The stylet-connecting step, when part of the method, includes functionally connecting the stylet <NUM>, <NUM>, or <NUM> to the console <NUM> as shown in <FIG>.

The stylet-inserting step includes inserting the stylet <NUM>, <NUM>, or <NUM> into a lumen of a catheter such as the catheter <NUM> as shown in <FIG> for the stylet <NUM> and <FIG> for the stylet <NUM>.

The clot-identifying step includes identifying an intraluminal clot in the catheter <NUM> by detecting changes in impedance with the one-or-more impedance sensors <NUM> in the distal portion of the stylet <NUM>. <NUM>, or <NUM>.

The clot-decomposing step includes decomposing the intraluminal clot with ultrasound to reestablish patency in the catheter <NUM>, which, in turn, can include decomposing the intraluminal clot by ultrasonic cavitation of fluid proximate the intraluminal clot, decomposing the intraluminal clot by ultrasonic agitation of a thrombolytic drug in the fluid proximate the intraluminal clot, decomposing the intraluminal clot by direct contact of the intraluminal clot with the stylet <NUM>, <NUM>, or <NUM> while the one-or-more ultrasound transducers <NUM> are in operation or the resonating section <NUM> of the stylet <NUM> is resonating with an ultrasonic frequency applied by the ultrasound probe <NUM>, or a combination thereof.

The method can further include a drug-injecting step in association with the clot-decomposing step of decomposing the intraluminal clot by ultrasonically agitating the thrombolytic drug in the fluid proximate the intraluminal clot. The drug-injecting step includes injecting the thrombolytic drug into the lumen of the catheter <NUM> before ultrasonically agitating the thrombolytic drug in the fluid proximate the intraluminal clot in the clot-decomposing step.

Claim 1:
A medical system (<NUM>) for ultrasonic decomposition of intraluminal clots, comprising:
a stylet (<NUM>, <NUM>, <NUM>) configured to insert into a lumen (<NUM>) of a catheter (<NUM>) including a fluid, the stylet (<NUM>, <NUM>, <NUM>) including:
one or more electrical impedance sensors (<NUM>) in a distal portion of the stylet (<NUM>, <NUM>, <NUM>), the one-or-more impedance sensors (<NUM>) configured to detect changes in impedance for identifying intraluminal clots in the catheter (<NUM>); and
one or more ultrasound transducers (<NUM>) embedded in the distal portion of the stylet (<NUM>, <NUM>, <NUM>), the one-or-more ultrasousnd transducers (<NUM>) configured for decomposing the intraluminal clots to reestablish patency in the catheter (<NUM>).