Dynamic pressure suction device driven by fluid pressure oscillator

Abstract

A suction modulation apparatus for use with a suction catheter and a vacuum source. The suction modulation apparatus includes a pressure manifold including a manifold cavity having a pressure chamber configured to contain a variable volume of pressure modulation fluid, a vacuum outlet configured to fluidically couple the vacuum source to the pressure chamber, and a vacuum inlet configured to fluidically couple the suction catheter to the pressure chamber. The suction modulation apparatus further includes a fluid pressure oscillator configured to oscillate the variable volume of pressure modulation fluid within the pressure chamber, thereby modulating the vacuum pressure within the pressure chamber.

Description

[0001] Invention Field This disclosure generally relates to medical devices and endovascular medical procedures, and more specifically, to devices and methods for aspirating objects from anatomical structures (e.g., aspirating clots from a patient's vascular system). Background of the Invention The general goal is to remove tissue from the body in the least invasive way possible to avoid damaging other tissues. For example, removing tissue (such as blood clots) from the vascular system can improve a patient's condition and quality of life.

[0003] Many vascular problems stem from insufficient blood flow through the blood vessels. One cause of insufficient or irregular blood flow is a blockage within the blood vessel, called a blood clot or thrombus, which can become an embolus in a patient's vascular system. Thrombi can occur for many reasons, including damage to the arterial wall caused by atherosclerotic disease, trauma from surgery, or other causes. When a thrombus forms, it can effectively block blood flow through the area where it forms. Sometimes, these thrombi dissolve harmlessly in the bloodstream. However, at other times, they can remain lodged in the blood vessel, where they can partially or completely obstruct blood flow. If a partially or completely blocked blood vessel is responsible for supplying blood to sensitive tissues such as the brain, lungs, or heart, it can lead to serious tissue damage.

[0004] For example, a blood clot in one of the carotid arteries can lead to ischemic stroke (AIS), caused by insufficient oxygen supply to vital areas of the brain. As another example, if one of the coronary arteries becomes 100% thrombosed, blood flow in that artery stops, resulting in a shortage of red blood cells that carry oxygen (used to supply, for example, the muscles that supply the heart walls, the myocardium). This lack of oxygen reduces or prevents muscle activity, causing chest pain (angina) and can lead to myocardial death, which can render the heart permanently incapacitated. If myocardial cell death is widespread, the heart will be unable to pump enough blood to meet the body's life-sustaining needs. In fact, a significant portion of the more than 1.2 million heart attacks in the United States are caused by blood clots (thrombi) that form within the coronary arteries. As yet another example, blood clots in the peripheral vascular system can lead to limb amputation.

[0005] When symptoms of blockage are evident, immediate action should be taken to reduce or eliminate the resulting tissue damage. In fact, clinical data suggest that thrombectomy may be beneficial or even necessary for improving outcomes. The ultimate goal of any treatment for these conditions of the arterial or venous system is to remove the blockage or restore patency quickly, safely, and cost-effectively. One approach is to treat the patient with thrombolytic drugs. However, these drugs do not immediately dissolve the blood clot in the patient's body, and they are often ineffective after a predetermined time window (usually 2 to 3 hours) following the onset of symptoms. Other approaches involve thrombectomy, which removes the blood clot by aspiration, mechanical retrieval, or a combination thereof. Mechanical retrieval typically involves a deployable mesh, such as a stent thrombectomy device, and is often complex and dangerous to perform.

[0006] Endovascular aspiration thrombectomy is a commonly used and effective treatment for removing clots from blood vessels, especially in cases of AIS. In a typical endovascular aspiration thrombectomy, a catheter is inserted into the patient's vascular system until the distal end of the catheter is just close to the clot, and a vacuum is applied at the proximal end of the catheter, resulting in the intake and subsequent removal of at least a portion of the clot into the catheter. Most aspiration systems are prone to tip occlusion when the clot being aspirated is too large for the aspiration tubing at the distal end of the catheter. Current techniques for endovascular thrombectomy in ischemic stroke utilize static loading. Once tip occlusion occurs, the pressure within the system drops sharply, often causing the aspirate to boil or cavitate within the system. As a result, water vapor is introduced into the system, reducing aspiration efficiency and making it more difficult (if not impossible) to bring the clot into the catheter.

[0007] Current trends aimed at improving aspiration efficiency have yielded some technological advancements. One approach utilizes catheters with larger inner diameters, facilitating clot removal by allowing potentially greater clot pull due to the increased aspiration area and / or by reducing resistance to thrombus entry into the larger lumen of the catheter. However, the use of such large-diameter catheters is limited because they cannot reach clots located in relatively small-diameter vessels within the patient's vascular system.

[0008] Another approach is to use “circular aspiration,” which dynamically applies aspiration pressure in various ways during aspiration to disrupt the structure of the thrombus and reduce the intake resistance of a given aspiration catheter, thereby improving efficiency and allowing the use of potentially smaller, more traceable catheters to achieve the same or better results as larger, less traceable catheters.

[0009] A system for dynamically loading suction pressure employs a cyclically activated valve or similar configuration to achieve pressure pulsation by blocking the mainstream flow. This is typically done manually or via an electromechanical or pneumatic valve that blocks suction flow from the attached suction conduit to the pump at specified time intervals. In some cases, pressure-sensing feedback has been suggested as a means of determining when to activate the valve. A cyclic loading method described in Simon S, Grey CP, Massenzo T, et al., “Exploring the efficacy of cyclic vs static aspiration in a cerebralthrombectomy model: an initial proof of concept study,” Journal of NeuroInterventional Surgery 2014; 6:677-683, and PCT Publication WO2014151209A8, employs a ventilation mechanism that automatically enters an oscillating pulse mode in response to the application of a vacuum to the attached suction conduit.

[0010] Another system for dynamically applying suction pressure, described in U.S. Patent Nos. 11,547,426 and 11,337,712, includes a vacuum source and a pressurized fluid source, each connected via valves to a manifold fluidly coupled to an attached suction conduit. For example, as... Figure 1As shown, the circulating aspiration system 1 typically includes a vacuum source (e.g., a vacuum pump) 2, a pressurization source (e.g., a saline bag) 3, and a pressure manifold 4 that fluidly couples the vacuum source 2 and the pressurization source 3 to the aspiration chamber (not shown) of the aspiration conduit 5. The circulating aspiration system 1 also includes an electronically triggered vacuum valve 6 fluidly coupled between the vacuum source 2 and the pressure manifold 4, an electronically triggered vent valve 7 fluidly coupled between the pressurization source 3 and the pressure manifold 4, and a valve controller 8 that electronically triggers the vacuum valve 6 and the vent valve 7 to open and close in any of a variety of ways to cause pressure pulsations within the pressure manifold 4, thereby moving the fluid column within the attached aspiration conduit 5. The circulating aspiration system 1 utilizes the pressure difference between the vacuum source 2 and the pressurization source 3, and the precise operation of the electronically, mechanically, or pneumatically triggered valves 6 and 7, to enable the pressure manifold 4 to rapidly pressurize (i.e., inject fluid) and depressurize (i.e., be exposed to vacuum). The circulating suction system 1 may further include a vacuum gauge 9 coupled between the vacuum source 2 and the pressure manifold 4, and a main gauge 10 coupled between the pressure manifold 4 and the suction conduit 5, for measuring the pressure at the input end (on the vacuum source side) and the output end (on the suction conduit side) of the manifold. The circulating suction system 1 may also include a pressure monitoring and operation unit 11, which monitors the fluid pressure measured by the gauges 9 and 10, and adjusts the timing and behavior of the valves 6 and 7 via a valve controller 8 to alter the overall performance of the suction system 1.

[0011] In one example, such as Figure 2 As shown, the circulating suction system 1 generates a pressure waveform 12 by essentially pulsating the pressure within the pressure manifold 4 between the baseline vacuum pressure of the vacuum source 2 and the ventilation pressure of the pressurization source 3. Specifically, when the vacuum valve 6 is open and the ventilation valve 7 is closed, the magnitude of the pressure waveform 12 rapidly decreases to the baseline vacuum pressure. Then, when the vacuum valve 6 is closed and the ventilation valve 7 is opened, the magnitude of the pressure waveform 12 rapidly increases above the ventilation pressure and then stabilizes at the ventilation pressure. The ventilation valve 7 is then closed while the vacuum valve 6 remains closed, so that the magnitude of the pressure waveform 12 remains at the ventilation pressure. This sequence is then repeated multiple times to repeatedly decrease and increase the amplitude of the pressure waveform 12 between the baseline vacuum pressure and the ventilation pressure.

[0012] Valve-based systems, such as Figure 1 The circulating aspiration system 1 has limited ability to accurately generate the desired pressure waveform because the time-resolved pressure within the manifold depends on many fixed parameters, such as the volume, shape, resistance, and compliance of the space and connections within the manifold; the construction, orifice size, resistance, and opening time of the valves; the hysteresis of the electronic systems used to sense pressure and control the valves; the length and resistance of the connections and valves to the vacuum and discharge baseline pressures of the vacuum and discharge fluid; and the inner diameter (ID), length, and compliance of the aspiration tubing, as well as the large volume of saline solution used to maximize aspiration effectiveness.

[0013] While the pressure extremes of the pressure waveforms generated by these valve-based systems can be adjusted in various ways, such as by adjusting the valve settings to the baseline pressures of the vacuum and venting sources, changing the shape of the pressure waveforms is much more difficult. In particular, flow resistance within the system can limit the rate of fluid exchange (i.e., between pressurized and vacuum lines), thus limiting the rate of pressure change. Furthermore, compliance within fluid line connections and suction lines can introduce secondary pressure oscillations. These behaviors can be optimized for a given set of operating parameters by changing the system hardware design and material selection, but altering them during system operation is difficult. For example, solenoid-based valves are widely used in electronically controlled flow systems; however, beyond basic opening and closing functions, they cannot be controlled to change the shape of the pressure and vacuum profiles. Even with feedback, it is difficult to predict the pressure at the distal end of the suction line without a complete understanding of all the aforementioned parameters and varying environmental conditions, including altitude variations.

[0014] It is worth noting that the shape of the pressure waveform generated at the distal end of the aspiration catheter, particularly the rate of pressure change and its frequency, is related to the degree of pressure effect applied to the target thrombus, and therefore can have a considerable impact on the effectiveness of dynamic pressure aspiration systems. Thus, better control of the pressure waveform shape at the distal end of the aspiration catheter can significantly influence the ability to optimize and enhance the aspiration system. However, valve-based systems are limited in their ability to accurately generate pressure waveforms, thus reducing their effectiveness in aspirating thrombi.

[0015] In addition, in order to generate a pressure waveform that varies between the ventilation pressure and the baseline vacuum pressure (such as...), Figure 2As shown, these valve-based systems require a vacuum source capable of providing a relatively high baseline vacuum (i.e., extremely low baseline absolute pressure). This vacuum source must be high-performance, thus increasing costs. Furthermore, due to the relatively high baseline vacuum required by these valve-based systems, significant blood loss and / or vascular collapse can occur when clots are not actively taken up by the aspiration catheter. Additionally, these valve-based systems require a constant source of saline solution to increase the pressure waveform level when the ventilation valve is open (i.e., pressurize the system). All saline solution flowing from the source, along with any tissue aspirated from the patient (e.g., blood or thrombus), eventually collects in an aspirate collection container, which must be replaced once full. Moreover, while it is desirable to determine the nature and amount of tissue collected from the patient (e.g., to confirm that a thrombus has been removed and to ensure that no excessive blood has been removed), this judgment is often difficult to make accurately due to the large amount of saline solution mixed in with the aspirate collection container. For example, often the only indication that tissue has been removed from the patient is that the fluid in the aspirate collection container is pinkish, which may not provide an indication of the nature and amount of tissue removed.

[0016] Therefore, a dynamic aspiration system is continuously needed, which can use a relatively low vacuum source and a relatively small amount of saline to more accurately and precisely generate pressure waveforms at the distal end of the aspiration catheter. Invention Overview According to a first aspect of the invention, a system is provided, comprising: a suction modulation device provided for use with a suction conduit and a vacuum source. The suction system may include the suction modulation device, the vacuum source, and the suction conduit.

[0018] The suction modulation device includes a pressure manifold comprising a manifold body, a vacuum outlet, and a vacuum inlet. The manifold body has a pressure chamber configured to contain a variable volume of pressure modulation fluid. The vacuum outlet is configured to fluidly couple a vacuum source to the pressure chamber, and the vacuum inlet is configured to fluidly couple a suction conduit to the pressure chamber. In one embodiment, the pressure manifold further includes a vent inlet configured to fluidly couple a pressurized fluid source to the pressure chamber. In this case, the suction modulation device may further include a fluid refill control element configured to selectively fluidly couple the pressurized fluid source to the pressure chamber. When the fluid pressure within the pressure chamber drops below a threshold fluid pressure, the fluid refill control element may be configured to deliver pressure modulation fluid from the pressurized fluid source into the pressure chamber.

[0019] The suction modulation device also includes a sensor configured to measure parameters indicating fluid pressure at the distal end of the suction cannula. In one embodiment, the sensor is a force feedback sensor configured to measure the force output of a fluid pressure oscillator. In another embodiment, the sensor is a pressure sensor, for example, a pressure sensor configured to measure fluid pressure within a pressure chamber.

[0020] The aspiration modulation device also includes a controller configured to dynamically modify a waveform signal corresponding to a modulated therapeutic pressure waveform in response to measured parameters. In one embodiment, the controller is configured to select one of a plurality of different modulated therapeutic pressure waveforms, in which case the dynamically modified waveform signal in response to measured parameters corresponds to the selected modulated therapeutic waveform. In an alternative embodiment, the aspiration modulation device also includes a user interface configured to receive user input for selecting a modulated therapeutic waveform.

[0021] The suction modulation device also includes a fluid pressure oscillator configured to oscillate a variable volume of pressure-modulated fluid within a pressure chamber according to a dynamically modified waveform signal, thereby modulating the vacuum pressure within the pressure chamber (e.g., a baseline vacuum pressure applied to the pressure chamber by a vacuum source) so that the fluid pressure at the distal end of the suction conduit tracks the desired modulated pressure waveform.

[0022] In one embodiment, the fluid pressure oscillator includes: a pressure transducer configured to engage with a pressure-modulating fluid within a pressure chamber; an actuator (e.g., a voice coil actuator) configured to be operatively coupled to the pressure transducer; and a driver (e.g., an electric driver) configured to control the actuator to physically move the pressure transducer in a manner that oscillates a variable volume of pressure-modulating fluid within the pressure chamber, thereby modulating the vacuum pressure within the pressure chamber such that the fluid pressure at the distal end of the suction conduit tracks a desired modulated pressure waveform. The actuator may be a linear actuator, in which case the driver may be configured to control the actuator to physically move the pressure transducer in a manner that reciprocates the variable volume of pressure-modulating fluid within the pressure chamber.

[0023] The pressure transducer element may include a movable manifold boundary, in which case the actuator may be configured to control the actuator to reciprocately move the movable manifold boundary. The movable manifold boundary may be a diaphragm fixed within the manifold cavity, thereby dividing the manifold cavity into a pressure chamber and a working chamber fluidly isolated from a vacuum inlet and a vacuum outlet. The actuator may be configured to control the actuator to physically move the diaphragm by flexing it. In one embodiment, the actuator may be directly mechanically coupled to the diaphragm. For example, the actuator may include a rod directly mechanically coupled to the diaphragm. In this embodiment, the actuator may be removably coupled to the diaphragm. In another embodiment, the actuator may be fluidly coupled to the diaphragm.

[0024] The pressure transducer can be a secondary pressure transducer (e.g., another diaphragm). In this case, the fluid pressure oscillator can also include a primary pressure transducer fluidly coupled to the secondary pressure transducer. For example, the primary pressure transducer can be a piston, and the actuator can include a piston shaft mechanically coupled to the piston. In this embodiment, the manifold cavity can include a cylinder with a decreasing diameter and a cylinder with a increasing diameter, the piston being reciprocally disposed in the cylinder with a decreasing diameter, and the diaphragm being fixed in the cylinder with a increasing diameter, such that the cylinder with a increasing diameter is divided into a pressure chamber and a working chamber. The working chamber contains the primary pressure modulating fluid, and the pressure modulating fluid contained in the pressure chamber is the secondary pressure modulating fluid. The primary pressure transducer can be contained within the manifold cavity or can be external to the manifold cavity. In the latter case, the suction modulation device can also include a flexible fluid conduit for fluidly coupling the primary pressure transducer to the secondary pressure transducer.

[0025] In an optional embodiment, the suction modulation device further includes another pressure oscillator. The fluid pressure oscillator and the other pressure oscillator can be configured to simultaneously and independently oscillate a variable volume of pressure-modulated fluid within the pressure chamber according to a dynamically modified waveform signal, thereby modulating the vacuum pressure within the pressure chamber such that the fluid pressure at the distal end of the suction conduit tracks a desired modulated pressure waveform (e.g., a modulated composite pressure waveform with at least two different fundamental frequencies).

[0026] In another alternative embodiment, the controller is further configured to generate multiple waveform signals corresponding to multiple different modulated diagnostic pressure waveforms (e.g., with different frequencies). In this case, the fluid pressure oscillator can be configured to sequentially oscillate a variable volume of pressure-modulated fluid within the pressure chamber according to the multiple waveform signals, thereby modulating the vacuum pressure within the pressure chamber. In this embodiment, the aspiration modulation device further includes a processor configured to analyze measured parameters in response to modulation of the vacuum pressure within the pressure chamber, and to generate or select modulated therapeutic pressure waveforms based on the analysis of the measured parameters. In one example, in response to thrombus occlusion of the aspiration catheter, the controller can be configured to generate multiple waveform signals, and the processor can be configured to determine one or more characteristics of the thrombus based on the analysis of the measured parameters, and to generate or select modulated therapeutic pressure waveforms based on the determined thrombus characteristics. In another example, when the aspiration catheter is connected to the aspiration modulation device, the controller can be configured to generate multiple waveform signals, and the processor can be configured to determine the type of aspiration catheter based on the analysis of the measured parameters, and to generate or select modulated therapeutic pressure waveforms based on the determined type of aspiration catheter.

[0027] In yet another optional embodiment, the suction modulation device further includes a master unit and a slave unit, the master unit including a first housing housing a controller, and the slave unit including a second housing housing at least a portion of a pressure manifold and a fluid pressure oscillator. The suction modulation device may also include flexible fluid lines that fluidly couple the master unit and the slave unit to each other. The master unit may be configured to be inserted into the second housing of the slave unit and electrically coupled to the slave unit when inserted into the second housing of the slave unit.

[0028] According to a second aspect of the invention, another suction modulation device is provided for use with a suction conduit and a vacuum source. The suction system may include this suction modulation device, a vacuum source, and a suction conduit.

[0029] The suction modulation device includes a pressure manifold, which includes a manifold body, a vacuum outlet, and a vacuum inlet. The manifold body has a pressure chamber configured to contain a variable volume of pressure modulation fluid. The vacuum outlet is configured to fluidly couple the vacuum source to the pressure chamber, and the vacuum inlet is configured to fluidly couple the suction conduit to the pressure chamber.

[0030] The suction modulation device also includes a fluid pressure oscillator comprising a diaphragm fixed within the manifold cavity, thereby dividing the manifold cavity into a pressure chamber and a working chamber fluidly isolated from the vacuum inlet and vacuum outlet. The fluid pressure oscillator is configured to oscillate a variable volume of pressure-modulating fluid within the pressure chamber via the diaphragm, thereby modulating the vacuum pressure within the pressure chamber (e.g., the baseline vacuum pressure applied to the pressure chamber by a vacuum source).

[0031] In one embodiment, the fluid pressure oscillator further includes: an actuator (e.g., a voice coil actuator) configured to be operatively coupled to a diaphragm; and a driver (e.g., an electric driver) configured to control the actuator to physically move the diaphragm in a manner that oscillates a variable volume of pressure-modulating fluid within a pressure chamber, thereby modulating the vacuum pressure within the pressure chamber. The actuator may be a linear actuator, in which case the driver may be configured to control the actuator to physically move the diaphragm in a manner that reciprocates the variable volume of the pressure-modulating fluid within the pressure chamber. The driver may be configured to control the actuator to physically move the diaphragm by flexing it. In one embodiment, the actuator may be directly mechanically coupled to the diaphragm. For example, the actuator may include a rod directly mechanically coupled to the diaphragm. In this embodiment, the actuator may be removably coupled to the diaphragm. In another embodiment, the actuator may be fluidly coupled to the diaphragm.

[0032] The diaphragm can be a secondary pressure transducer (e.g., another diaphragm), in which case the fluid pressure oscillator may also include a primary pressure transducer (e.g., another diaphragm) fluidly coupled to the secondary pressure transducer. For example, the primary pressure transducer may be a piston, and the actuator may include a piston shaft mechanically coupled to the piston. In this embodiment, the manifold cavity may include a cylinder with a decreasing diameter and a cylinder with a increasing diameter, the piston being reciprocally disposed in the cylinder with a decreasing diameter, and the secondary pressure transducer being fixed in the cylinder with a increasing diameter, such that the cylinder with a increasing diameter is divided into a pressure chamber and a working chamber. The working chamber contains the primary pressure modulating fluid, and the pressure modulating fluid contained in the pressure chamber is the secondary pressure modulating fluid. The primary pressure transducer may be contained within the manifold cavity or may be external to the manifold cavity. In the latter case, the suction modulation device may also include a flexible fluid conduit for fluidly coupling the primary pressure transducer to the secondary pressure transducer.

[0033] In an optional embodiment, the aspiration modulation device further includes a controller configured to output a waveform signal corresponding to a modulated therapeutic pressure waveform. In this embodiment, a fluid pressure oscillator is configured to oscillate a variable volume of pressure-modulated fluid within a pressure chamber via a diaphragm according to the waveform signal, thereby modulating the vacuum pressure within the pressure chamber. In this embodiment, the aspiration modulation device may further include a sensor configured to measure parameters indicating fluid pressure at the distal end of the aspiration catheter. In this case, the controller may be configured to dynamically modify the waveform signal in response to the measured parameters, and the fluid pressure oscillator may be configured to oscillate a variable volume of pressure-modulated fluid within the pressure chamber via a diaphragm according to the dynamically modified waveform signal, such that the fluid pressure at the distal end of the aspiration catheter tracks the desired modulated pressure waveform.

[0034] In another optional embodiment, the suction modulation device further includes a master unit and a slave unit, the master unit including a first housing housing a controller, and the slave unit including a second housing housing at least a portion of a pressure manifold and a fluid pressure oscillator. The suction modulation device may also include flexible fluid lines that fluidly couple the master unit and the slave unit to each other. The master unit may be configured to be inserted into the second housing of the slave unit and electrically coupled to the slave unit when inserted into the second housing of the slave unit.

[0035] According to a third aspect of the invention, another suction modulation device is provided for use with a suction conduit and a vacuum source. The suction system may include the suction modulation device, the vacuum source, and the suction conduit.

[0036] The suction modulation device includes a pressure manifold, which includes a manifold body, a vacuum outlet, and a vacuum inlet. The manifold body has a pressure chamber configured to contain a variable volume of pressure modulation fluid. The vacuum outlet is configured to fluidly couple the vacuum source to the pressure chamber, and the vacuum inlet is configured to fluidly couple the suction conduit to the pressure chamber.

[0037] The suction modulation apparatus further includes a plurality of fluid pressure oscillators configured to simultaneously oscillate a variable volume of pressure modulation fluid within a pressure chamber, thereby modulating the vacuum pressure within the pressure chamber (e.g., a baseline vacuum pressure applied to the pressure chamber by a vacuum source). In one embodiment, the plurality of fluid pressure oscillators are configured to independently oscillate a variable volume of pressure modulation fluid within a pressure chamber, thereby modulating the vacuum pressure within the pressure chamber.

[0038] In one embodiment, each of the plurality of fluid pressure oscillators includes: a pressure transducer (e.g., a diaphragm) configured to engage with a pressure-modulating fluid within a pressure chamber; an actuator (e.g., a voice coil actuator) configured to operatively couple to the pressure transducer; and a driver (e.g., an electric driver) configured to control the actuator to physically move the pressure transducer in a manner that oscillates a variable volume of pressure-modulating fluid within the pressure chamber, thereby modulating the vacuum pressure within the pressure chamber such that the fluid pressure at the distal end of the suction conduit tracks a desired modulated pressure waveform. The actuator may be a linear actuator, in which case the driver may be configured to control the actuator to physically move the pressure transducer in a manner that reciprocates the variable volume of the pressure-modulating fluid within the pressure chamber.

[0039] Each respective fluid pressure oscillator's pressure transducer element may include a movable manifold boundary, in which case an actuator may be configured to control an actuator to reciprocately move the movable manifold boundary. The movable manifold boundary may be a diaphragm fixed within the manifold cavity, thereby dividing the manifold cavity into a pressure chamber and a working chamber fluidly isolated from the vacuum inlet and vacuum outlet. The actuator may be configured to control the actuator to physically move the diaphragm by flexing it. The diaphragms of two fluid pressure oscillators in a plurality of fluid pressure oscillators may be opposite each other, such that the manifold cavity is divided into a pressure chamber between opposing diaphragms and a working chamber outside opposing diaphragms, the working chamber being fluidly isolated from the vacuum inlet and vacuum outlet, wherein the two fluid pressure oscillators are configured to simultaneously oscillate a variable volume of pressure-modulating fluid within the pressure chamber via the respective diaphragm, thereby modulating the vacuum pressure within the pressure chamber.

[0040] The actuator for each respective fluid pressure oscillator can be a linear actuator, in which case the driver for each respective fluid pressure oscillator can be configured to control the actuator to physically move the diaphragm in a manner that reciprocates by altering the variable volume of the pressure-modulating fluid within the pressure chamber. The driver can be configured to control the actuator to physically move the diaphragm by causing it to flex. In one embodiment, the actuator for each respective fluid pressure oscillator can be directly and mechanically coupled to the diaphragm of each respective fluid pressure oscillator. For example, the actuator for each respective fluid pressure oscillator can include a rod directly and mechanically coupled to the diaphragm of each respective fluid pressure oscillator. In this embodiment, the actuator for each respective fluid pressure oscillator can be removably coupled to the diaphragm of each respective fluid pressure oscillator. In another embodiment, the actuator can be fluidly coupled to the diaphragm.

[0041] In an optional embodiment, the aspiration modulation device further includes a controller configured to output a waveform signal corresponding to a modulated therapeutic pressure waveform (e.g., a composite pressure waveform having at least two different fundamental frequencies). In this embodiment, a plurality of fluid pressure oscillators are configured to simultaneously oscillate a variable volume of pressure-modulated fluid within a pressure chamber according to the waveform signal, thereby modulating the vacuum pressure within the pressure chamber. In this embodiment, the aspiration modulation device may further include a sensor configured to measure parameters indicating fluid pressure at the distal end of the aspiration catheter. In this case, the controller may be configured to dynamically modify the waveform signal in response to the measured parameters, and the plurality of fluid pressure oscillators are configured to simultaneously oscillate a variable volume of pressure-modulated fluid within the pressure chamber according to the dynamically modified waveform signal, such that the fluid pressure at the distal end of the aspiration catheter tracks the desired modulated pressure waveform.

[0042] According to a fourth aspect of the invention, another suction modulation device is provided for use with a suction conduit and a vacuum source. The suction system may include the suction modulation device, the vacuum source, and the suction conduit.

[0043] The suction modulation device includes a pressure manifold comprising a manifold body, a vacuum outlet, a vacuum inlet, and a vent inlet. The manifold body has a pressure chamber configured to contain a variable volume of pressure modulation fluid. The vacuum outlet is configured to fluidly couple a vacuum source to the pressure chamber. The vacuum inlet is configured to fluidly couple a suction conduit to the pressure chamber. The vent inlet is configured to fluidly couple a pressurized fluid source (e.g., atmospheric pressure) to the pressure chamber.

[0044] The suction modulation device further includes a fluid pressure oscillator configured to oscillate the variable volume of the pressure modulation fluid within the pressure chamber, thereby modulating the vacuum pressure within the pressure chamber. In one embodiment, the fluid pressure oscillator includes: a pressure transducer configured to engage with the pressure modulation fluid within the pressure chamber; an actuator (e.g., a voice coil actuator) configured to be operatively coupled to the pressure transducer; and a driver (e.g., an electric driver) configured to control the actuator to physically move the pressure transducer in a manner that oscillates the variable volume of the pressure modulation fluid within the pressure chamber, thereby modulating the vacuum pressure within the pressure chamber. The actuator may be a linear actuator, in which case the driver may be configured to control the actuator to physically move the pressure transducer in a manner that reciprocates to change the variable volume of the pressure modulation fluid within the pressure chamber. The pressure transducer may include a movable manifold boundary, in which case the driver may be configured to control the actuator to reciprocate to move the movable manifold boundary. The movable manifold boundary can be a diaphragm fixed within the manifold cavity, thereby dividing the manifold cavity into a pressure chamber and a working chamber fluidly isolated from the vacuum inlet and vacuum outlet. An actuator can be configured to control an actuator to physically move the diaphragm by flexing it. In one embodiment, the actuator can be directly mechanically coupled to the diaphragm. For example, the actuator can include a rod directly mechanically coupled to the diaphragm. In this embodiment, the actuator can be removably coupled to the diaphragm. In another embodiment, the actuator can be fluidly coupled to the diaphragm.

[0045] The suction modulation device also includes a fluid refill control element (e.g., a check valve) configured to selectively fluid couple a pressurized fluid source to a pressure chamber. In one embodiment, the fluid refill control element is configured to deliver pressure-modulated fluid from the pressurized fluid source to the pressure chamber when the fluid pressure in the pressure chamber drops below a threshold fluid pressure.

[0046] In an optional embodiment, the aspiration modulation device further includes a controller configured to output a waveform signal corresponding to a modulated therapeutic pressure waveform. In this embodiment, a fluid pressure oscillator is configured to oscillate a variable volume of pressure-modulated fluid within a pressure chamber via a pressure transducer element according to the waveform signal, thereby modulating the vacuum pressure within the pressure chamber. In this embodiment, the aspiration modulation device may further include a sensor configured to measure parameters indicating fluid pressure at the distal end of the aspiration catheter. In this case, the controller may be configured to dynamically modify the waveform signal in response to the measured parameters, and the fluid pressure oscillator may be configured to oscillate a variable volume of pressure-modulated fluid within the pressure chamber via a diaphragm according to the dynamically modified waveform signal, such that the fluid pressure at the distal end of the aspiration catheter tracks the desired modulated pressure waveform.

[0047] According to a fifth aspect of the invention, another suction modulation device is provided for use with a suction conduit and a vacuum source. The suction system may include the suction modulation device, the vacuum source, and the suction conduit.

[0048] The aspiration modulation device includes a controller and a pressure manifold. The controller is configured to output a waveform signal corresponding to a modulated therapeutic pressure waveform. The pressure manifold includes a manifold body, a vacuum outlet, and a vacuum inlet. The manifold body has a pressure chamber configured to contain a variable volume of pressure-modulating fluid. The vacuum outlet is configured to fluidly couple a vacuum source to the pressure chamber, and the vacuum inlet is configured to fluidly couple a suction catheter to the pressure chamber. The aspiration modulation device also includes a fluid pressure oscillator configured to oscillate the variable volume of pressure-modulating fluid within the pressure chamber according to the waveform signal, thereby modulating the vacuum pressure within the pressure chamber (e.g., a baseline vacuum pressure applied to the pressure chamber by a vacuum source).

[0049] The suction modulation device further includes a master unit and a slave unit. The master unit includes a housing carrying a controller, and the slave unit includes a housing carrying at least a portion of a pressure manifold and at least a portion of a fluid pressure oscillator. The master unit is configured to be operatively coupled to and operatively decoupled from the slave unit. In one embodiment, the housing of the master unit carries at least another portion of the fluid pressure oscillator. In another embodiment, the master unit is configured to be inserted into the slave unit.

[0050] In another embodiment, the fluid pressure oscillator includes: a pressure transducer carried by the slave unit and configured to engage with the pressure-modulated fluid within the pressure chamber; an actuator (e.g., a voice coil actuator) configured to be operatively coupled to the pressure transducer; and a driver (e.g., an electric driver) configured to control the actuator to physically move the pressure transducer in a manner that causes the variable volume of the pressure-modulated fluid within the pressure chamber to oscillate, thereby modulating the vacuum pressure within the pressure chamber such that the fluid pressure at the distal end of the suction conduit tracks a desired modulated pressure waveform. In this embodiment, the pressure transducer is carried by the housing of the slave unit, and the driver is carried by the housing of the master unit. The actuator may be carried by the housing of the master unit. The respective housings of the master and slave units may be housing portions directly mechanically fixed to each other to form a single housing.

[0051] The actuator may be a linear actuator, in which case the actuator can be configured to physically move the pressure transducer element by reciprocating the variable volume of the pressure modulating fluid within the pressure chamber. The pressure transducer element may include a movable manifold boundary, in which case the actuator can be configured to control the actuator to reciprocate the movement of the movable manifold boundary. The movable manifold boundary may be a diaphragm fixed within a manifold cavity, thereby dividing the manifold cavity into a pressure chamber and a working chamber fluidly isolated from vacuum inlet and vacuum outlet. The actuator can be configured to control the actuator to physically move the diaphragm by flexing it. In one embodiment, the actuator may be directly mechanically coupled to the diaphragm. For example, the actuator may include a rod directly mechanically coupled to the diaphragm. In this embodiment, the actuator may be removably coupled to the diaphragm. In another embodiment, the actuator may be fluidly coupled to the diaphragm.

[0052] The pressure transducer can be a secondary pressure transducer (e.g., another diaphragm). In this case, the fluid pressure oscillator can also include a primary pressure transducer fluidly coupled to the secondary pressure transducer. For example, the primary pressure transducer can be a piston, and the actuator can include a piston shaft mechanically coupled to the piston. In this embodiment, the manifold cavity can include a cylinder with a decreasing diameter and a cylinder with a increasing diameter, the piston being reciprocally disposed in the cylinder with a decreasing diameter, and the diaphragm being fixed in the cylinder with a increasing diameter, such that the cylinder with a increasing diameter is divided into a pressure chamber and a working chamber. The working chamber contains the primary pressure modulating fluid, and the pressure modulating fluid contained in the pressure chamber is the secondary pressure modulating fluid. The primary pressure transducer can be contained within the manifold cavity or can be external to the manifold cavity. In the latter case, the suction modulation device can also include a flexible fluid conduit for fluidly coupling the primary pressure transducer to the secondary pressure transducer.

[0053] In an alternative embodiment, the suction modulation further includes a sensor carried by the slave unit, the sensor being configured to measure a parameter indicating fluid pressure at the distal end of the suction catheter, wherein the controller is configured to dynamically modify a waveform signal in response to the measured parameter, and wherein a fluid pressure oscillator is configured to oscillate a variable volume of pressure-modulated fluid within a pressure chamber according to the dynamically modified waveform signal, such that the fluid pressure at the distal end of the suction catheter tracks the desired modulated pressure waveform.

[0054] According to a sixth aspect of the invention, a suction device is provided for use with a suction conduit and a vacuum source. The suction system may include the suction device, the vacuum source, and the suction conduit.

[0055] The suction device includes a pressure manifold comprising a manifold body having a pressure chamber and a working chamber, a vacuum outlet configured to couple a vacuum source fluid to the pressure chamber, and a vacuum inlet configured to couple a suction conduit fluid to the pressure chamber. The suction device also includes a diaphragm fixed within the manifold body for fluid isolation between the pressure chamber and the working chamber. The diaphragm is configured to apply a blockage-clearing pressure to the suction fluid contained in the pressure chamber in response to a force applied from the working chamber to the diaphragm.

[0056] In one embodiment, the vacuum outlet is configured to couple a vacuum source fluid to the pressure chamber during a blockage-clearing pressure applied by the diaphragm to the suction fluid contained within the pressure chamber. The suction fluid contained within the pressure chamber is a pressure-modulating fluid with a variable volume; in this case, the suction device may further include a fluid pressure oscillator configured to apply an oscillating force to the diaphragm. The diaphragm may be configured to oscillate the variable volume of pressure-modulating fluid within the pressure chamber in response to the oscillating force applied to the diaphragm, thereby modulating the vacuum pressure within the pressure chamber (e.g., in any of the various ways discussed above).

[0057] In another embodiment, the diaphragm is further configured to decouple the vacuum source from the pressure chamber fluid by sealing the vacuum outlet before the diaphragm applies clogging clearance pressure to the suction fluid contained in the pressure chamber. In this embodiment, the diaphragm may have a sealing region and a deflectable region. The sealing region is configured to contact the vacuum outlet to seal it from the pressure chamber, and the deflectable region is configured to deflect within the pressure chamber to apply clogging clearance pressure to the suction fluid contained in the pressure chamber. The sealing region may be, for example, a central circular region of the diaphragm, and the deflectable region may be, for example, an annular region of the diaphragm.

[0058] In this embodiment, the diaphragm can be configured to seal and isolate the vacuum outlet from the pressure chamber in response to a pressure in the working chamber exceeding a sealing pressure threshold. The diaphragm can be configured to apply a blockage-clearing pressure to the aspiration fluid contained in the pressure chamber in a dedicated manner. The diaphragm can be further configured to fluidly recouple the vacuum source to the pressure chamber by unsealing the vacuum outlet in response to a pressure in the working chamber falling below an unsealing pressure threshold. In this case, the unsealing pressure threshold may be less than the sealing pressure threshold when the aspiration catheter is still blocked by a thrombus, or greater than the sealing pressure threshold when the thrombus in the aspiration catheter is cleared. In an alternative embodiment, the aspiration device may further include a spring configured to bias the diaphragm to unseal the vacuum outlet from the pressure chamber, and / or the diaphragm may have a passive restoring force for biasing the diaphragm to unseal the vacuum outlet from the pressure chamber.

[0059] If the diaphragm is further configured to fluidly recouple the vacuum source to the pressure chamber, the diaphragm is configured to apply a clogging relief pressure to the suction fluid contained in the pressure chamber as a pressure pulse output. In this case, the diaphragm can be configured to apply a pressure pulse output to the suction fluid contained in the pressure chamber in response to a pressure pulse input applied to the working fluid contained in the working chamber. The peak amplitude of the pressure pulse input is higher than the sealing pressure threshold. The diaphragm is configured to optionally include a series of pressure pulse outputs to apply the clogging relief pressure to the suction fluid contained in the pressure chamber. In this case, the diaphragm can be configured to apply a series of pressure pulse outputs to the suction fluid contained in the pressure chamber in response to a series of pressure pulse inputs applied to the working fluid contained in the working chamber by a pressure control device.

[0060] In this embodiment, the diaphragm can be configured to couple the vacuum source to the pressure chamber in response to the removal of a pressure pulse input from the working fluid contained in the working chamber, in which case the pressure of the reference amplitude of the pressure pulse input may be lower than the unsealing pressure threshold. Alternatively, the diaphragm can be configured to maintain the separation of the vacuum source from the pressure chamber in response to the removal of a pressure pulse input from the working fluid contained in the working chamber, in which case the pressure of the reference amplitude of the pressure pulse input may be higher than the unsealing pressure threshold.

[0061] The suction device may also include a pressure control device configured to apply a pressure pulse input to a working fluid contained in a working chamber. In one example, the pressure control device may include a three-way valve configured to apply the pressure pulse input to the working fluid contained in the working chamber by alternately fluidly coupling the working chamber to the atmosphere and another vacuum source. In another example, the pressure control device may include a pressure generator configured to apply a pressure pulse input to the working fluid contained in the working chamber by generating a pressure pulse input. The suction device may also include a sensor configured to measure a parameter indicating the fluid pressure at the distal end of the suction conduit, in which case the pressure control device may be configured to apply a pressure pulse input to the working fluid contained in the working chamber in response to the measured parameter. In an optional embodiment, a diaphragm may be configured to modulate the pressure pulse input such that a pressure pulse output corresponds to the modulated pressure pulse input.

[0062] Other and additional aspects and features of the disclosed embodiments of the invention will become apparent from the following detailed description, taking into account the accompanying drawings. Brief description of the attached diagram The accompanying drawings illustrate the design and use of preferred embodiments of the disclosed invention, wherein similar elements are indicated by common reference numerals. It should be noted that the drawings are not drawn to scale, and throughout the drawings, elements having similar structures or functions are indicated by the same reference numerals. It should also be noted that the drawings are intended only to facilitate the description of embodiments. They are not intended as an exhaustive description of the invention or as a limitation on the scope of the invention, which is defined only by the appended claims and their equivalents. Furthermore, the embodiments shown in the disclosed invention do not need to have all the aspects or advantages shown. Moreover, aspects or advantages described in connection with specific embodiments of the disclosed invention are not necessarily limited to that embodiment and can be practiced in any other embodiment, even if not so shown.

[0064] To better understand how the above and other advantages and objectives of the disclosed invention are obtained, a more specific description of the disclosed invention, briefly described above, will be presented with reference to specific embodiments shown in the accompanying drawings. It should be understood that these drawings depict only exemplary embodiments of the invention and are therefore not to be construed as limiting the scope of the invention. The invention will be described and explained in conjunction with additional features and details using the drawings, wherein: Figure 1 This is a conceptual diagram of a dual-valve circulating suction system based on existing technology; Figure 2 It is shown by Figure 1 A timing diagram of an exemplary pressure waveform generated by a dual-valve circulating suction system; Figure 3 This is a block diagram of an embodiment of the dynamic suction system constructed according to the present invention; Figure 4 Is Figure 3 A plan view of an exemplary suction cannula used in a dynamic suction system; Figure 5 yes Figure 4 The diagram shows the distal end of the aspiration catheter in a plan view when used to aspirate obstructions from the patient's vascular system. Figure 6 It is shown by Figure 3 A timing diagram of an exemplary pressure waveform generated by a dynamic suction system; Figures 7A-7C It is possible Figure 3 A plan view of an embodiment of the suction modulation device used in a dynamic suction system, specifically showing the fluid pressure oscillator of the suction modulation device in three different states; Figures 8A-8C It is possible Figure 3 A plan view of another embodiment of the suction modulation device used in the dynamic suction system, specifically showing the fluid pressure oscillator of the suction modulation device in three different states; Figure 9A -Figure 7G is available Figure 3 A plan view of another embodiment of the suction modulation device used in the dynamic suction system, specifically showing the situation when the dual-fluid pressure oscillator of the suction modulation device is in seven different states; Figures 10A-10C It is possible Figure 3 A plan view of another embodiment of the suction modulation device used in the dynamic suction system, specifically showing the situation when a portion of the fluid pressure oscillator of the main unit of the suction modulation device is in three different states; Figures 11A to 11C yes Figures 10A to 10C A plan view of the suction modulation device, specifically showing the situation when a portion of the fluid pressure oscillator of the suction modulation device is in three different states; Figure 12 It is possible Figure 3 A perspective view of another embodiment of the suction modulation device used in the dynamic suction system; Figure 13 yes Figure 12 A perspective view of the main unit and slave unit of the suction modulation device; Figures 14A-14C These are plan views of different states of an embodiment of the suction pulse device constructed according to the present invention; Figure 15A It can be used Figures 14A-14C A top view of an embodiment of a diaphragm in a suction pulse device; Figure 15B yes Figure 15A A cross-sectional perspective view of the diaphragm; Figures 16A-16C yes Figures 14A-14C Timing diagrams of different pressure waveform inputs and the resulting pressures in a suction pulse device; Figures 17A-17C Is it possible to... Figures 14A-14C Plan views of two embodiments of a pressure control device used in conjunction with a suction pulse device; Figures 18A-18C Yes, it can be entered. Figures 14A-14C Timing diagrams of different pressure waveform inputs in a suction pulse device; and Figure 19 yes Figures 14A-14C Timing diagram of the pressure waveform input and the resulting modulated pressure waveform output in the suction pulse device.

[0065] Detailed description of the illustrated embodiments refer to Figure 3An embodiment of a dynamic suction system 20 constructed according to the disclosed invention will now be described. The dynamic suction system 20 typically includes a suction conduit 22, a vacuum source 24, a pressurized fluid source 26, a suction material collection container 28, and a suction modulation device 30.

[0066] Further reference Figure 4 and Figure 5 The aspiration catheter 22 includes an elongated catheter body 32 and an aspiration cavity 34 extending through the catheter body 32 between its proximal end 36 and distal end 38. Figure 5 (Seen in dashed lines). When using the dynamic aspiration system 20, the proximal end 36 of the aspiration catheter 22 remains outside the patient's vascular system 100 and is accessible to the operator, while the distal end 38 of the catheter body 32 is sized and dimensional to reach obstructions 102 (e.g., thrombi) at remote locations within the patient's vascular system 100. Figure 5 As best shown in the diagram. The aspiration catheter 22 includes a distal inlet port 40 communicating with the aspiration chamber 34 of the aspiration catheter 22, and the thrombus 102 is aspirated into this distal inlet port by the aspiration catheter 22. The thrombus 102 can be completely aspirated into the aspiration catheter 22, or it can be broken into pieces and aspirated into the aspiration catheter 22 piece by piece.

[0067] The aspiration catheter 22 may include multiple regions with different constructions and / or properties along its length. For example, the outer diameter of the distal portion of the catheter body 32 may be smaller than that of the proximal portion of the catheter body 32 to reduce the profile of the distal portion of the catheter body 32 and facilitate navigation in tortuous vascular systems. Furthermore, the distal portion of the catheter body 32 may be more flexible than the proximal portion. Typically, the proximal portion of the catheter body 32 may be formed of a harder material than the distal portion, allowing sufficient maneuverability for advancement through the patient's vascular system 100, while the distal portion may be formed of a more flexible material, allowing it to remain flexible and more easily travel along the guidewire to reach remote locations in tortuous regions of the vascular system 100. The catheter body 32 may be composed of suitable polymeric materials, metals, and / or alloys, such as polyethylene, stainless steel, or other suitable biocompatible materials or combinations thereof. In some cases, the proximal portion of the catheter body 32 may include a reinforcing layer, such as a braided or coiled layer, to enhance the maneuverability of the catheter body 32. The catheter body 32 may include a transition region between the proximal and distal portions of the catheter body 32.

[0068] Return to reference Figure 3During operation, vacuum source 24 applies a baseline vacuum pressure to aspiration modulation device 30. This baseline vacuum pressure is lower than the patient's mean arterial pressure (MAP) and preferably lower than atmospheric pressure, and can therefore be considered as a vacuum capable of drawing thrombus 102 into the aspiration chamber 34 of aspiration catheter 22 (e.g., Figure 5 (As shown). This baseline vacuum pressure can be controlled and adjusted by the user as needed to aspirate tissue. During any given period of time during the tissue removal procedure, the user can set the baseline vacuum pressure level to be constant or can vary the vacuum level. The vacuum source 24 can be, for example, a conventional pump (e.g., a rotary vane pump, diaphragm pump, peristaltic pump, or venturi pump) or a syringe configured to generate a low pressure (i.e., the base vacuum pressure) within the aspiration chamber 34 of the aspiration catheter 22.

[0069] It is worth noting that, due to the use of the suction modulation device 30 (described in further detail below), the vacuum source 24 can operate at relatively low vacuum pressures (e.g., 30 to 60 kPa (absolute) / -70 to -40 kPa (gauge)), which, in absolute pressure terms, is higher than the pressure required for valve-based systems. Because the baseline vacuum pressure of the vacuum source 24 does not need to be very high, the vacuum source 24 can be of lower performance, or even in the form of a house vacuum line. The vacuum source 24 may include a regulator (not shown) for maintaining the output of the vacuum source 24 at a consistent level.

[0070] The pressurized fluid source 26 can be, for example, a reservoir containing a liquid at atmospheric pressure (such as physiological saline (e.g., a saline infusion bag) or ambient air). It should be understood that the pressurized fluid source 26 is pressurized because the pressure of the fluid it contains is higher than the lowest vacuum level (i.e., the highest baseline vacuum pressure) reached in the aspiration chamber 34 of the aspiration catheter 22 when the vacuum source 24 is operating. Therefore, even though the pressurized fluid source 26 in the illustrated embodiment may be at low pressure (i.e., at ambient pressure or an absolute pressure of one atmosphere), it is still pressurized relative to the pressure experienced by the aspiration chamber 34 of the aspiration catheter 22 during operation of the vacuum source 24. The aspirate collection container 28 can be any suitable container in fluid communication with the vacuum source 24 via an exhaust line, enabling aseptic collection and disposal of aspirated tissue. Alternatively, the aspirate collection container 28 can be located between the vacuum source 24 and the aspiration catheter 22. A safety valve (not shown) may be installed in the suction collection container 28 to prevent fluid or material from entering the vacuum source 24.

[0071] While the aspiration catheter 22, vacuum source 24, pressurized fluid source 26, and aspirate collection container 28 can be conventional in nature, the aspiration modulation device 30 is unconventional. Specifically, instead of alternately pressurizing and depressurizing the aspiration catheter 22 via a valve system, the device modulates the pressure within the aspiration chamber 34 of the aspiration catheter 22. As a result, during periods of no or low flow (e.g., if the thrombus 102 obstructs the aspiration chamber 34 of the aspiration catheter 22 or if there is a flow anomaly in the aspiration circuit of the dynamic aspiration system 20), it facilitates the removal of the thrombus 102 through the aspiration catheter 22. Furthermore, by modulating the vacuum pressure within the aspiration chamber 34 of the aspiration catheter 22, the baseline vacuum pressure applied to the aspiration catheter 22 by the vacuum source 24 can be relatively low, thereby minimizing blood loss and / or vascular collapse during free flow conditions (e.g., when the aspiration chamber 34 is not blocked and the aspiration circuit of the dynamic aspiration system 20 is operating as intended).

[0072] Furthermore, the aspiration modulation device 30 can modulate the vacuum pressure within the aspiration chamber 34 of the aspiration catheter 22 without using excessive saline solution, which can be used only for the initial perfusion of the dynamic aspiration system 20. As a result, most of the material contained in the aspirate collection container 28 will be tissue removed from the patient, allowing the nature and amount of this tissue to be determined by rapid examination of the aspirate collection container 28.

[0073] In the illustrated embodiment, the suction modulation device 30 modulates the vacuum pressure within the suction chamber 34 of the suction conduit 22 by modulating the baseline vacuum pressure applied to the suction conduit 22 by the vacuum source 24 (i.e., by causing the fluid pressure within the suction conduit 22 to oscillate near the baseline vacuum pressure). For example, as Figure 6 As shown, the suction modulation device 30 can generate a therapeutic pressure waveform 110 that oscillates near the baseline vacuum pressure (i.e., the pressure drops below the baseline vacuum pressure, then rises above the baseline vacuum pressure, and in the case shown, above the ventilation pressure (i.e., the pressure of the pressurized fluid source 26), falls back below the ventilation pressure, and then below the baseline vacuum pressure, etc.). Therefore, this is consistent with the pressure waveform 12 that varies between the baseline vacuum pressure and the ventilation pressure (in... Figure 2 Compared to a dual-valve aspiration system (i.e., the maximum value (peak) of pressure waveform 12 is essentially the ventilation pressure, and the minimum value (valley) of pressure waveform 12 is essentially the vacuum pressure), the maximum and minimum values ​​of treatment pressure waveform 110 are not determined by baseline vacuum pressure and ventilation pressure.

[0074] It should be understood that although the baseline vacuum pressure applied by the vacuum source 24 to the suction modulation device 30 is modulated, making Figure 6The maximum and minimum values ​​of the treatment pressure waveform 110 shown are equidistant from the baseline vacuum pressure (i.e., the minimum and maximum pressures are offset from the baseline vacuum pressure equally). However, the suction modulation device 30 can modulate vacuum pressures other than the baseline vacuum pressure, such that the maximum and minimum values ​​of the treatment pressure waveform 110 are not equidistant from the baseline vacuum pressure (i.e., the distance offset of the maximum value from the baseline vacuum pressure is greater than the distance offset of the minimum value from the baseline vacuum pressure, and vice versa). Furthermore, although... Figure 6 The maximum value of the treatment pressure waveform 110 shown is higher than the ventilation pressure; however, it should be understood that the peak value of the treatment pressure waveform 110 can be lower than the ventilation pressure. Furthermore, although... Figure 6 The magnitudes of all maximum and minimum values ​​of the therapeutic pressure waveform 110 shown are uniform, but... Figure 6 The magnitude of the maximum and / or minimum values ​​of the therapeutic pressure waveform 110 shown may be non-uniform. Preferably, the maximum value of the therapeutic pressure waveform 110 is lower than the patient's mean arterial pressure (MAP), such that any thrombus 102 captured within the distal end 38 of the catheter body 32 will not be ejected back into the patient's artery. In some cases, the maximum value of the therapeutic pressure waveform 110 may be modulated to temporarily exceed the patient's MPAP, thereby amplifying the range of forces applied to the thrombus 102. This enhanced force can effectively weaken the resistance of the thrombus 102 or fatigue the structural network of the thrombus 102, thereby promoting more efficient uptake without causing distal movement of the thrombus 102.

[0075] It is worth noting that the aspiration modulation device 30 modulates the baseline vacuum pressure applied to the aspiration catheter 22 by the vacuum source 24 in a manner that accurately and precisely generates the desired modulated therapeutic pressure waveform at the distal end 38 of the catheter body 32. This modulated therapeutic pressure waveform may be complex. For example, as... Figure 6 As shown, the modulated therapeutic pressure waveform 110 includes different composite components, including a rectangular component 112, a sine component 114, and a truncated sine or sawtooth component 116. Of course, alternative modulated therapeutic pressure waveforms can be simple, for example, pure sine curves, pure rectangles, etc. In fact, as will be described in further detail below, the modulated therapeutic pressure waveform 110 can be arbitrary, because the suction modulation device 30 can be programmed (e.g., pre-programmed during manufacturing, programmed during subsequent system upgrades, programmed by the user, etc.) to generate any modulated therapeutic pressure waveform 110 (therapeutic or diagnostic) with a desired shape, desired frequency, desired duty cycle, desired amplitude, desired midpoint, etc., or the suction modulation device 30 can customize such a programmed modulated therapeutic pressure waveform 110 according to a diagnostic scenario.

[0076] It is worth noting that the suction modulation device 30 is capable of accurately and precisely generating the desired modulated pressure waveform at the distal end 38 of the catheter body 32 using pressure feedback control. In particular, the suction modulation device 30 can modulate the baseline vacuum pressure applied to the suction catheter 22 by the vacuum source 24, such that the fluid pressure measured (directly or indirectly) at the distal end 38 of the catheter body 32 tracks the desired pressure waveform.

[0077] It is worth noting that using pressure feedback to generate the desired modulated pressure waveform in the aspiration catheter should contrast with aspiration systems that can modulate the baseline vacuum pressure in an open-loop manner or using other feedback (e.g., positioning feedback, such as using an encoder or positioning sensor), which may result in decorrelation between the controlled modulation of the baseline vacuum pressure and the desired pressure waveform at the distal end 38 of the catheter body 32 due to factors such as air bubbles in the dynamic aspiration system, and may also have a relatively slow response time.

[0078] Conversely, when pressure feedback is used, the controlled modulation of the baseline vacuum pressure will have a higher correlation with the fluid pressure at the distal end 38 of the conduit body 32 and can have a faster response time. Therefore, the suction modulation device 30 can operate without actuator sensors, which simplifies feedback in closed-loop control and further allows for fast response and high modulation capability. This arrangement avoids control-dependent, load-induced motion modulation in the dynamic suction system 20, enabling high-speed force / torque output for a more consistent modulated pressure waveform. For example, when pressure feedback control is employed, direct frequency / velocity modulation, direct amplitude distribution pulses, or programmable parameter inputs of the transfer function are all possible operating modes.

[0079] Optionally, the aspiration modulation device 30 can perform in-situ diagnostic procedures during active aspiration by simultaneously monitoring the pressure response to the modulated input pressure waveform (e.g., a single pulse, frequency sweep, or chirp). The aspiration modulation device 30 can then analyze the monitored pressure response and detect or identify in vivo conditions such as aspiration flow status (e.g., free flow (no clot), mixed flow (active clot aspiration), and no flow (distal catheter blocked by clot)), flow phase type (e.g., pure fluid, clot and fluid mixture, fluid and gas mixture, etc.), clot characteristics (e.g., clot elasticity, clot fragility, etc.), vascular wall obstruction of the distal inlet port 40 of the aspiration catheter 22, and the amount of vascular flow attenuation caused by the aspiration catheter 22. For example, the time-domain response to the modulated waveform can help understand vascular patency. The response amplitude and response time constant of the modulated waveform can distinguish between free flow and obstruction states. Frequency-domain analysis of the response to the modulated scan can depict tissue characteristics, clot elasticity, and clot type. Depending on the type of information to be acquired, each of the different types of pressure modulation can have different diagnostic capabilities. Such information can be used in a way that when a continuous flow is detected after complete agglomerate removal, the suction modulation device 30 can be shut down (or the intensity of the pressure change in the baseline vacuum pressure can be reduced) and the baseline vacuum pressure can be lowered.

[0080] In an advantageous embodiment, the suction modulation device 30 can be operated to dynamically tune the dynamic suction system 20 in situ in response to sensed conditions. For example, the suction modulation device 30 can monitor the suction flow rate to determine the flow conditions of the suction and automatically modify the desired modulated therapeutic pressure waveform in response to the monitored flow conditions. In one embodiment, the suction flow rate can be determined by modulating the input pressure waveform and analyzing the pressure response. Alternatively, a flow sensor can be used to directly measure the suction flow rate. When free-flow conditions are determined, the suction modulation device 30 can switch to a “free-flow” mode, for example, by applying a relatively low duty cycle and a relatively high absolute baseline vacuum pressure to the modulated pressure waveform. When mixed-flow conditions are determined, the suction modulation device 30 can switch to an “active uptake” mode, for example, by applying a relatively moderate duty cycle along with a relatively moderate absolute baseline vacuum pressure to the modulated pressure waveform. When no flow conditions are determined, the suction modulation device 30 can switch to a “blocked” mode, for example, by applying a relatively high duty cycle along with a relatively low absolute baseline vacuum pressure to the modulated pressure waveform. As another example, the suction modulation device 30 can monitor the suction flow rate to determine the type of flow phase (e.g., pure fluid, clump and fluid mixture, fluid and gas mixture, etc.) and automatically select or modify the modulated pressure waveform according to the determined flow phase type.

[0081] In another advantageous embodiment, the aspiration modulation device 30 can be operated to detect thrombi by generating multiple different modulated diagnostic pressure waveforms (e.g., by modulating the amplitude, frequency, duty cycle, and / or shape of the input pressure waveform) while monitoring the pressure response to such modulated diagnostic pressure waveforms.

[0082] For example, in response to a blockage in the distal end 38 of the catheter body 32, the aspiration modulation device 30 can perform a pressure frequency sweep of the input pressure waveform (i.e., generate multiple diagnostic pressure waveforms with different frequencies) while monitoring the pressure response to the pressure frequency sweep. The aspiration modulation device 30 can then perform a spectral analysis of the monitored pressure response to identify the optimal frequency for disrupting a single clot (with unknown composition) (e.g., the frequency providing the maximum feedback pressure response), and then automatically modulate the baseline vacuum pressure at that identified frequency until the clot is completely taken up. For example, the frequency (or frequency range) required for clot take-up may depend on the clot's modulus.

[0083] For example, if the clot is determined to be relatively hard, the suction modulation device 30 can operate automatically in a "hard clot" mode, which modulates the baseline vacuum pressure at a first frequency (or within a frequency range centered on the first frequency). If the clot is determined to be relatively soft, the suction modulation device 30 can operate automatically in a "soft clot" mode, which modulates the baseline vacuum pressure at a second different frequency (or within a frequency range centered on the second frequency). In the "hard clot" mode, the baseline vacuum pressure can be modulated at a relatively high frequency but a relatively low amplitude, causing the clot to be drawn in piecewise (i.e., clot fragments are gradually peeled off and taken in). In the "soft clot" mode, the baseline vacuum pressure can be modulated at a relatively high amplitude but a relatively high frequency, causing the clot to be taken in as a whole.

[0084] Alternatively or additionally, the suction modulation device 30 can perform pressure amplitude sweep (i.e., generate multiple pressure waveforms with different amplitudes) and / or pressure duty cycle sweep (i.e., generate multiple pressure waveforms with different duty cycles) while monitoring the pressure response to the pressure amplitude and / or pressure duty cycle sweeps to identify the optimal pressure amplitude and / or pressure duty cycle that disrupts a single intake (with unknown composition).

[0085] In yet another advantageous embodiment, the aspiration modulation device 30 can be operated to pre-tune the dynamic aspiration system 20 dynamically, for example, by pre-screening the aspiration catheter 22 when it is connected to the aspiration modulation device 30 but not yet inserted into the patient. The aspiration modulation device 30 can then calibrate the dynamic aspiration system 20 for a specific aspiration catheter 22 (not only the type and size of the aspiration catheter 22, but also the specific aspiration catheter 22 currently in use).

[0086] For example, the distal end 38 of the catheter body 32 can be plugged, information about the clinical scenario can be input into the aspiration modulation device 30 (e.g., the blood vessel where the thrombus is located, the local atmospheric pressure, the patient's blood pressure, temperature, blood viscosity, etc.), and the aspiration modulation device 30 can generate multiple different diagnostic pressure waveforms (e.g., by performing a frequency sweep of the input pressure waveform) while monitoring the pressure response to the modulated input pressure waveform.

[0087] The aspiration modulation device 30 can customize or tune the modulated therapeutic pressure waveform by setting the operating parameters of the dynamic aspiration system 20 (e.g., by performing an inverse transform of spectral analysis). This includes the baseline vacuum pressure applied to the aspiration catheter 22 by the vacuum source 24 and the characteristics of the pressure waveform (e.g., amplitude, frequency, shape, duty cycle, complexity, etc.) to achieve optimal performance for a given clinical scenario and given characteristics of the aspiration catheter 22. Alternatively, the aspiration modulation device 30 can select a modulated therapeutic pressure waveform from a library or lookup table of modulated therapeutic pressure waveforms corresponding to different types of aspiration catheters. That is, the aspiration modulation device 30 can match a specific aspiration catheter 22 with one of the aspiration catheter types stored in the library or lookup table and select the modulated therapeutic pressure waveform corresponding to the matched type of aspiration catheter.

[0088] In one example, the vessel containing the thrombus could be the middle cerebral artery (MCA) or the internal carotid artery (ICA), which may require different modulation frequencies and / or amplitudes to efficiently and safely remove the thrombus. For instance, when removing a thrombus from the MCA, it may not be desirable to move the aspiration catheter 22 too much during the aspiration procedure; therefore, a lower frequency and / or lower amplitude modulation of the base vacuum pressure may be needed to prevent damage to the MCA. In this case, the aspiration modulation device 30 may automatically set the frequency and / or amplitude modulation of the base vacuum pressure (e.g., by customizing or selecting a modulated pressure waveform) to a relatively low level in response to receiving clinical information indicating that the thrombus is located in the MCA. Conversely, since the ICA is a relatively large artery, it may be desirable to modulate the base vacuum pressure with a higher frequency and / or a higher amplitude to maximize the efficiency of thrombus removal. In this case, the aspiration device 30 may automatically set the frequency and / or amplitude modulation of the base vacuum pressure to a relatively high level in response to receiving clinical information indicating that the thrombus is located in the ICA. In this configuration, the aspiration modulation device 30 can automatically set the frequency and / or amplitude modulation of the baseline vacuum pressure (e.g., by customizing or selecting a modulated pressure waveform) to a relatively high level in response to receiving clinical information indicating that the thrombus is located in the ICA. The modulation characteristics of the baseline vacuum pressure set by the aspiration modulation device 30 can also depend on the size of the aspiration catheter 22 relative to the size of the vessel where the thrombus is located.

[0089] exist Figure 3 In the illustrated embodiment, the suction modulation device 30 typically includes a user / data input device (e.g., a user interface (UI)) 42, a controller / processor 44, a pressure manifold 46, a sensor 48, a fluid pressure oscillator 50, a fluid refill control element 52, and a vacuum flow control element 54.

[0090] UI 42 may take the form of a control panel (e.g., having a display, buttons, keypad, touchscreen, microphone configured to receive voice commands, etc.) and provide user input to controller / processor 44 for turning aspiration modulation device 30 on and off, providing the aforementioned clinical scenario information to facilitate the calibration of dynamic aspiration system 20, changing the operating mode of dynamic aspiration system 20 (e.g., calibration mode, dynamic mode (active modulation of baseline vacuum pressure), static vacuum mode (no modulation of baseline vacuum pressure), and diagnostic mode), selecting different desired modulated therapeutic pressure waveforms, etc. (e.g., by selecting or adjusting the modulation frequency or selecting from multiple different modulated therapeutic pressure waveforms previously stored in memory (not shown) (e.g., in a library or lookup table)). UI 42 may optionally use light or sound to provide status / warning information to indicate modes, settings, events, operating modes, free-flow aspiration, active clot uptake, catheter occlusion, high / low pressure, clot type / modulus, diagnostic data, patient data, etc.

[0091] The controller / processor 44 provides power and logic control to the aspiration modulation device 30 and may take the form of, for example, a microcontroller, for receiving input from the UI 42 and controlling the fluid pressure oscillator 50 (described in further detail below) based on user input (e.g., changing the operating mode or selecting the modulated pressure waveform). The controller / processor 44 is configured to dynamically modify the waveform signal corresponding to the modulated therapeutic pressure waveform in response to fluid pressure measured at the distal end 38 of the aspiration catheter 22 or within the pressure manifold 46, and output the dynamically modified waveform signal. This dynamic modification of the waveform signal helps to ensure that the fluid pressure at the distal end 38 of the aspiration catheter 22 tracks the desired modulated pressure waveform. The desired modulated pressure waveform can be arbitrary, as any conceivable modulated pressure waveform (including...) can be envisioned. Figure 5 The modulated composite therapeutic pressure waveform 110 shown is illustrated.

[0092] The controller / processor 44 can select such a modulated therapeutic pressure waveform from a number of different modulated therapeutic pressure waveforms (e.g., stored in a library or lookup table), or the controller / processor 44 can customize such a modulated therapeutic pressure waveform. The controller / processor 44 can communicate with the fluid pressure oscillator 50 via a wired or wireless connection. The controller / processor 44 may optionally include a battery (not shown).

[0093] The controller / processor 44 can also be configured to analyze or interpret pressure data derived from parameters measured by sensor 48 during the execution of the diagnostic procedures described above, and to generate or select a desired modulated therapeutic pressure waveform. Specifically, the controller / processor 44 is configured to generate multiple waveform signals corresponding to multiple different modulated diagnostic pressure waveforms (e.g., with different frequencies). As will be described in further detail, a fluid pressure oscillator modulates the baseline vacuum pressure according to the waveform signals. The controller / processor 44 is also configured to analyze the measured parameters in response to the modulation of the baseline vacuum pressure, and to generate or select a modulated therapeutic pressure waveform based on the analysis of the measured fluid parameters. The controller / processor 44 can implement any of the in-situ diagnostic or pre-diagnostic procedures described above.

[0094] For example, the controller / processor 44 is configured to generate multiple waveform signals in response to a thrombus obstructing the aspiration catheter 22, determine one or more characteristics of the thrombus based on analysis of measured parameters, and generate or select a modulated therapeutic pressure waveform based on the determined characteristics of the thrombus. As another example, the controller / processor 44 may generate a modulated therapeutic waveform, or it may select a modulated therapeutic waveform from a library or lookup table of modulated therapeutic waveforms based on the calibration of the aspiration catheter 22. Specifically, when the aspiration catheter 22 is connected to the aspiration modulation device 30, the controller / processor 44 is configured to generate multiple waveform signals, determine the type of the aspiration catheter 22 based on analysis of measured parameters, and generate or select a modulated therapeutic pressure waveform based on the determined type of the aspiration catheter 22.

[0095] The pressure manifold 46 includes a manifold cavity 56, a vacuum inlet 58, and a vacuum outlet 60. The vacuum inlet 58 is configured to fluidly couple the suction conduit 22 to a pressure chamber of the manifold cavity 56 (described in more detail below), and the vacuum outlet 60 is configured to fluidly couple a vacuum source 24 (via the aspirate collection container 28) to the manifold cavity 56, thereby enabling the vacuum source 24 to apply a reference vacuum pressure to the suction conduit 22. The pressure manifold 46 also includes a vent inlet 62 configured to fluidly couple a pressurized fluid source 26 to the manifold cavity 56. The pressure manifold 46 can be coupled to the suction conduit 22, the vacuum source 24, and the pressurized fluid source 26 using a connector (not shown), or alternatively, can be integrated with the suction conduit 22, the vacuum source 24, and the pressurized fluid source 26 without using a connector.

[0096] A fluid pressure oscillator 50 is configured to oscillate a variable volume of pressure-modulating fluid (described further below) within a manifold cavity 56 (i.e., alternately increasing and decreasing the variable volume of the pressure-modulating fluid within the manifold cavity 56), thereby modulating the baseline vacuum pressure (i.e., the fluid pressure within the manifold cavity 56 oscillates around the baseline vacuum pressure). In other words, increasing the variable volume of the pressure-modulating fluid in the manifold cavity 56 via the fluid pressure oscillator 50 correspondingly decreases the pressure in the manifold cavity 56, while decreasing the variable volume of the pressure-modulating fluid in the manifold cavity 56 via the fluid pressure oscillator 50 correspondingly increases the pressure in the manifold cavity 56. The variable volume of the pressure-modulating fluid within the manifold cavity 56 can be alternately increased and decreased globally, causing the fluid pressure to alternately drop below the baseline vacuum pressure and rise above the baseline vacuum pressure (e.g., to generate...). Figure 6 The rectangular component 112 and the sinusoidal component 114 of the therapeutic pressure waveform 110 shown are either locally increased and decreased alternately, causing the fluid pressure to increase and decrease alternately, but remaining below or above the baseline vacuum pressure (e.g., to produce...). Figure 5 The truncated sinusoidal or sawtooth component 116 of the therapeutic pressure waveform 110 shown.

[0097] As will be described in further detail below, the fluid pressure oscillator 50 modulates the vacuum pressure within the manifold cavity 56 according to a waveform signal that has been dynamically modified by the controller / processor 44 in response to parameters measured by the sensor 48 (indicating the fluid pressure at the distal end 38 of the suction conduit 22), such that the fluid pressure measured by the sensor 48 tracks the desired modulated pressure waveform; or alternatively, modulated according to multiple waveform signals corresponding to multiple different modulated diagnostic pressure waveform signals.

[0098] In the illustrated embodiment, the fluid pressure oscillator 50 includes a pressure transducer 66, an actuator 68, and a driver 70. The pressure transducer 66 is directly engaged with a pressure-modulated fluid within the manifold cavity 56 (and particularly within the pressure chamber of the manifold cavity 56, as will be discussed in further detail below), and is configured to oscillate this variable-volume pressure-modulated fluid by physical movement, thereby converting mechanical energy into fluid energy. The actuator 68 is configured to be operatively coupled to the pressure transducer 66, and particularly to physically move the pressure transducer 66 in an oscillating manner. As will be described in further detail below, the pressure transducer 66 may advantageously include a movable manifold boundary (e.g., a diaphragm) fixed within the manifold cavity 56, while the actuator may include, for example, a voice coil actuator, a motor, a rotary-linear cam, a solenoid, an audio exciter, a peristaltic pump, a rotary vane, a gear, a screw, a syringe, a pneumatic piston, a pneumatic pulse generator, etc.

[0099] The driver 70 is configured to control the actuator 68 based on a modulated pressure waveform signal customized by or selected by the controller / processor 44 (e.g., selected from a database or lookup table, or based on a user selection—e.g., by changing or selecting a parameter of the modulated pressure waveform, such as the modulation frequency) to physically move the pressure transducer 66, thereby causing the variable volume of pressure-modulated fluid within the manifold cavity 56 to oscillate, and thus modulate the vacuum pressure within the manifold cavity 56.

[0100] In one embodiment, the driver 70 is inherently electric (i.e., the driver 70 electrically drives the actuator 68 (e.g., if the actuator 68 is in the form of a voice coil), but in alternative embodiments, the driver 70 may use other forms of energy to drive the actuator 68, including electromagnetic, pneumatic, hydraulic, etc. The driver 70 may include a waveform generator and an actuator controller capable of controlling the fluid pressure oscillator 50 in a very precise manner, such that the fluid pressure measured by the sensor 48 tracks the desired modulated pressure waveform.

[0101] Although the controller / processor 44 and driver 70 are described herein as separate components, it should be understood that some or all of the functions of the controller / processor 44 and driver 70 may be performed by a single component. Furthermore, although all the functions of the controller / processor 44 are described herein as being performed by a single component, and similarly, all the functions of the driver 70 are described herein as being performed by a single component, such functions of each of the controller / processor 44 and driver 70 may be distributed among several components. For example, control functions may be performed by a single controller, while processing functions may be performed by a single processor. It should be understood that those skilled in the art are familiar with the terms "controller," "processor," and "driver," and they may be implemented in software, firmware, hardware, or any suitable combination thereof. Sensor 48 is configured to measure fluid pressure at the distal end 38 of the catheter body 32 to provide fluid pressure feedback to actuator 70, thereby enabling direct control of the fluid pressure in manifold cavity 56. Furthermore, because the fluid pressure in manifold cavity 56 is directly controlled, actuator 68 can utilize pure open-loop position control. Optionally, one or more actuator sensors (e.g., position feedback sensors) 72 may be initially used to calibrate actuator 68 (e.g., to determine the midpoint and upper and lower limits of actuator 68), and then shut down after this calibration, after which open-loop position control of actuator 68 can be utilized, enabling a higher level of accuracy for actuator 68 at higher frequencies.

[0102] In one embodiment, sensor 48 is a pressure sensor located in the distal end 38 of the catheter body 32, allowing direct measurement of fluid pressure in the distal end 38 of the catheter body 32. Alternatively, it may be a pressure sensor located in the manifold cavity 56 or even in the fluid pressure oscillator 50, allowing indirect measurement of fluid pressure in the distal end 38 of the catheter body 32 or inference from fluid pressure measurements in the manifold cavity 56 or the fluid pressure oscillator 50. Alternatively, sensor 48 may be a force feedback sensor that measures the output force of actuator 68.

[0103] The fluid pressure in the fluid pressure oscillator 50 (e.g., in the manifold cavity 56) can be inferred based on the size of the actuator 68, and thus the fluid pressure at the distal end 38 of the catheter body 32 can be inferred. For example, the fluid pressure in the manifold cavity 56 can be calculated based on a measured force (e.g., by the controller / processor 44 by dividing the measured force by the known area on which the actuator 68 acts on the fluid pressure oscillator 50).

[0104] In an advantageous embodiment, actuator 68 has an input fed by driver 70 that is proportional to the output force of actuator 68 and therefore proportional to the fluid pressure within the distal end 38 of catheter body 32. In this case, sensor 48 can take the form of a circuit that measures the amplitude of the electrical input (e.g., a current sensing circuit), thus eliminating the need for a separate sensor in catheter body 32 or manifold cavity 56.

[0105] It is worth noting that using sensor 48 to measure the fluid pressure indicating the fluid pressure at the distal end 38 of the conduit body 32 allows the fluid pressure oscillator 50 to more accurately generate the desired pressure waveform at the distal end 38 of the conduit body 32, as described above. In an alternative embodiment, sensor 48 or another sensor may be used to generate a fluid pressure profile, which can be analyzed (e.g., by actuator 70) to detect system leaks, embolisms, siphon interruptions, pressure losses, and other problems.

[0106] The fluid refill control element 52 is configured to selectively fluid couple pressurized fluid source 26 to manifold cavity 56 via vent inlet 62 to maintain the working volume (or fluid pressure) of pressure-modulating fluid within manifold cavity 56 at a desired average value, and thus maintain the desired average fluid pressure within manifold cavity 56. Specifically, although fluid enters manifold cavity 56 via vacuum inlet 58 and exits manifold cavity 56 via vacuum outlet 60, the amount of fluid exiting manifold cavity 56 may be greater than the amount entering manifold cavity 56, resulting in a decrease in the average fluid volume of manifold cavity 56 due to excessive fluid being drawn from it, thereby reducing the fluid pressure within it. However, the fluid refill control element 52 periodically or continuously injects small amounts of pressure-modulating fluid from pressurized fluid source 26 into manifold cavity 56 via vent inlet 62 to maintain the desired average volume of pressure-modulating fluid, thereby maintaining the desired average fluid pressure within manifold cavity 56.

[0107] In the illustrated embodiment, the fluid refill control element 52 includes a one-way valve disposed in fluid communication between the pressurized fluid source 26 and the vent inlet 62, such that when the fluid pressure within the manifold cavity 56 drops below a threshold fluid pressure (in this case, the fluid pressure of the pressurized fluid source 26), the one-way valve opens, allowing pressure-regulating fluid to be delivered from the pressurized fluid source 26 into the manifold cavity 56. In this way, the average design fluid pressure within the manifold cavity 56 is maintained despite the loss of blood / fluid through the vacuum outlet 60 and into the aspirate collection container 28. When the fluid pressure within the manifold cavity 56 rises above the fluid pressure of the pressurized fluid source 26, the one-way valve closes, preventing fluid from being delivered from the manifold cavity 56 into the pressurized fluid source 26.

[0108] Because the fluid refill control element 52 fluidly couples the pressurized fluid source 26 to the manifold lumen 56 only when necessary (i.e., it is designed to inject saline into the manifold lumen 56 only occasionally), the amount of saline that eventually enters the aspirate collection container 28 will be minimal, thus allowing for easier determination of the nature and amount of tissue removed from the patient.

[0109] Furthermore, the fluid refill control element 52 can be designed to provide a low-pressure safety limit by opening in response to a drop in fluid pressure within the manifold cavity 56 below a specific fluid pressure. Therefore, the fluid refill control element 52 provides a low-pressure safety limit for the suction modulation device 30 by preventing the fluid pressure within the manifold cavity 56 from dropping below a specific fluid pressure value. In one embodiment, the fluid refill control element 52 may also incorporate a feedback sensor / controller (not shown) for monitoring the pressure within the manifold cavity 56, which checks the pressure when the pressure transducer element 66 is in its midpoint / average / neutral position to determine whether the pressure is at a preset setpoint pressure for that position of the actuator 68. In this way, the position of the actuator 68 is more closely correlated with the actual pressure within the manifold cavity 56.

[0110] In an alternative embodiment, the fluid refill control element 52 includes a constant pressure system (not shown) that can be used to provide a consistent pressure to the manifold cavity 56 via passive or active pressure regulation devices (such as pressure regulators, pressure bladders, or pressure bubbles) to eliminate system performance differences between different facilities located at different altitudes and therefore having different absolute atmospheric pressures. Thus, the constant pressure system enables the fluid refill control element 52 to supply the manifold cavity 56 with a constant atmospheric pressure equivalent pressure-modulated fluid, thereby allowing the fluid pressure oscillator 50 to accurately generate the desired modulated pressure waveform, which is essential for the effectiveness of suction.

[0111] Vacuum flow control element 54 is configured to prevent blood / fluid from flowing back from aspirate collection container 28 into manifold cavity 56. For example, vacuum flow control element 54 may include a minimum flow resistance check valve disposed in fluid communication between aspirate collection container 28 and vacuum outlet 60, such that when the fluid pressure within pressure manifold 46 drops below a reference vacuum pressure (e.g., in…),… Figure 5 During the trough of the treatment pressure waveform 110 shown, the one-way valve closes, thereby preventing fluid / blood from being delivered from the aspirate collection container 28 into the manifold lumen 56.

[0112] In an optional embodiment, the suction modulation device 30 further includes one or more overpressure relief valves (not shown) configured to release pressure from the manifold cavity 56 if the fluid pressure within the manifold cavity 56 exceeds a maximum threshold limit. In another optional embodiment, the suction modulation device 30 further includes means (not shown) for adjusting the baseline vacuum pressure to a desired baseline vacuum pressure. In yet another optional embodiment, the suction modulation device 30 further includes a barometric pressure sensor (not shown) configured to measure local barometric pressure (e.g., due to altitude changes or transient weather conditions) such that the vacuum source 24 can adjust the baseline vacuum pressure accordingly relative to this barometric pressure to maintain a desired pressure difference between the baseline vacuum pressure and the measured barometric pressure. In yet another optional embodiment, the suction modulation device 30 further includes means (not shown) for adjusting the baseline vacuum pressure to a desired baseline vacuum pressure.

[0113] Now for reference Figures 7A to 7C A specific embodiment of the suction modulation device 30a will be described below. The suction modulation device 30a includes a single housing or enclosure 72 housing a controller / processor 44 and a fluid pressure oscillator 50a. In the illustrated embodiment, the housing 72 is a two-part housing comprising a top housing portion 72a and a bottom housing portion 72b, which are removably coupled to each other to facilitate the reuse of a portion of the suction modulation device 30a, as will be discussed in further detail below. The controller / processor 44 and the driver 70 are contained within the top housing portion 72a, while the UI 42 is fixed to the exterior of the top housing portion 72a. The bottom housing portion 72b at least partially forms a pressure manifold 46, wherein a manifold cavity 56 is formed within the bottom housing portion 72b, and a vacuum inlet 58 (which may be in the form of a male Luer lock connector), a vacuum outlet 60 (which may be in the form of a female Luer lock connector), together with a vacuum flow control element 54 and a vent inlet 62 (which may be in the form of a female Luer lock connector), together with a fluid refill control element 52, are fixed to the bottom housing portion 72b and are in fluid communication with the manifold cavity 56. A sensor 48 is fixed to the bottom housing portion 72b and maintains fluid communication with the manifold cavity 56.

[0114] Because the control functions are performed by components in the top housing portion 72a and the operating functions are performed by components in the bottom housing portion 72b, the top housing portion 72a can be considered as the master unit, and the bottom housing portion 72b can be considered as the slave unit. Further embodiments of the master and slave units will be discussed below.

[0115] exist Figures 7A-7CIn the illustrated embodiment, the fluid pressure oscillator 50a is in the form of a directly driven diaphragm assembly. Specifically, the fluid pressure oscillator 50a includes a pressure transducer 66a in the form of a movable manifold boundary (particularly a diaphragm) that divides a manifold cavity 56 into a pressure chamber 56a and a working chamber 56b. The pressure chamber contains a variable volume of pressure-modulated fluid 74, which is in fluid communication with a vacuum inlet 58, a vacuum outlet 60, and a vent inlet 62. The working chamber is fluidly isolated from these three components. The pressure chamber 56a of the manifold cavity 56 is defined by the bottom wall 76 and side walls 78 of the bottom housing portion 72b and the opposing diaphragm 66a. Therefore, it is understood that the diaphragm 66a sterilely seals and isolates the working chamber 56b of the manifold 56 from the pressure modulated fluid 74 contained in the pressure chamber 56a of the manifold 56, thereby preventing cross-contamination between the pressure chamber 56a and the working chamber 56b.

[0116] The fluid pressure oscillator 50a also includes a linear actuator 68a (e.g., a voice coil) comprising an actuator housing 80 and a rod 82 directly mechanically coupled to a diaphragm 66a via a coupler 84. This allows the diaphragm 66a to alternately flex away from the actuator housing 80 and toward the bottom wall 76 of the housing 72 from a nominal flex state, thereby reciprocatingly oscillating the variable volume pressure modulating fluid 74 within the manifold cavity 56, and thus oscillating the fluid pressure within the manifold cavity 56. The actuator housing 80 is contained within a top housing portion 72a, while the rod 82 is disposed within a bottom housing portion 72b.

[0117] like Figure 7A As shown, rod 82 is in a nominal position relative to actuator housing 80, such that diaphragm 66a is in a nominal flexural state relative to bottom wall 76 of housing 72, and pressure chamber 56a has a nominal volume of pressure-modulated fluid 74 at a nominal fluid pressure (in this case, at baseline vacuum pressure). Figure 7B As shown, when rod 82 is linearly translated away from actuator housing 80 from its nominal position (downward as indicated by the arrow), diaphragm 66a flexes from its nominal flexed state toward the bottom wall 76 of housing 72, thereby reducing the volume of pressure modulating fluid 74, and consequently increasing the fluid pressure in pressure chamber 56a from the baseline vacuum pressure. Conversely, as Figure 7C As shown, when rod 82 is linearly translated from its nominal position toward actuator housing 80 (upward as indicated by the arrow), diaphragm 66a flexes away from the bottom wall 76 of housing 72 from its nominal flex state, thereby increasing the volume of pressure modulating fluid 74, which in turn causes the fluid pressure in pressure chamber 56a to decrease from the baseline vacuum pressure accordingly.

[0118] Although the nominal position of lever 82 is shown as the center position between its maximum and minimum linear translation, the baseline vacuum pressure applied by vacuum source 24 to pressure chamber 56a is based on... Figure 6 The therapeutic pressure waveform 110 shown is modulated (i.e., the average pressure in pressure chamber 56a is equal to the baseline vacuum pressure), but the nominal position of rod 82 can also be shifted away from the center relative to the maximum and minimum linear translation, so that a vacuum pressure different from the baseline vacuum pressure applied to pressure chamber 56a by vacuum source 24 is modulated.

[0119] In an advantageous embodiment, coupler 84 removably couples rod 82 to diaphragm 66a, allowing actuator 68a, including rod 82, to be easily detached from diaphragm 66a. For example, coupler 84 can be a screw, snap-fit ​​mechanism, slotted insert coupler, snap-fit ​​fitting, pin connector, magnetic retainer, threaded connector, or any other mechanism that can be quickly manipulated to detach rod 82 of actuator 68a from diaphragm 66a. As described above, top housing portion 72a carries the more expensive components (in this case, electronic components) of suction regulating device 30a, including UI 42, controller / processor 44, actuator 68a, and driver 70, while bottom housing portion 72b carries the less expensive components (in this case, passive components), including diaphragm 66a, vacuum inlet 58, vacuum outlet 60 (together with vacuum flow control element 54), and vent inlet 62 (together with fluid refill control element 52).

[0120] Because the bottom housing portion 72b is removably coupled to the top housing portion 72a, and the rod 82 of the actuator 68a is removably coupled to the diaphragm 66a, the top housing portion 72a, along with its contents, can be made reusable, while the bottom housing portion 72b, along with its contents, can be made disposable. That is, after use, the bottom housing portion 72b, including the diaphragm 66a, vacuum inlet 58 (and vacuum flow control element 54), vacuum outlet 60, and vent inlet 62 (and fluid refill control element 52), can be removed from the top housing portion 72a and discarded, and replaced with a new bottom housing portion 72b including a new diaphragm 66a, a new vacuum inlet 58 (and vacuum flow control element 54), a new vacuum outlet 60, and a new vent inlet 62 (and fluid refill control element 52) ​​for subsequent use.

[0121] Alternatively, the bottom housing portion 72b, including its contents, can be removed from the top housing portion 72a, resterilized, and reattached to it. In this way, the top housing portion 72a, as well as the more sensitive electronic components (which are already aseptically isolated from the pressure-modulated fluid 74 contained in the sterile bottom housing portion 72b by the diaphragm 66a), do not need to be sterilized, thereby preventing thermal damage to the electronic components and / or eliminating the need for more expensive electronic components that can withstand one or more thermal cycles used in a typical sterilization process.

[0122] Now for reference Figures 8A to 8C Another specific embodiment of the suction modulation device 30b will be described below. The suction modulation device 30b is similar to the one described above. Figures 7A-7C The modulation device 30a differs in that the suction modulation device 30b includes a fluid pressure oscillator 50b in the form of an indirect-drive diaphragm assembly.

[0123] Specifically, the fluid pressure oscillator 50b includes a primary pressure transducer 66b in the form of a piston and a secondary pressure transducer 66c in the form of a movable manifold boundary (particularly a diaphragm). The manifold cavity 56 (in this case, the top housing portion 72a) includes a cylinder 86 with a reduced upper diameter, in which the piston 66b is reciprocating. The manifold 56 (in this case, the bottom housing portion 72b) includes a lower diameter cylinder 88 in which a diaphragm 66c is fixed, such that the lower diameter cylinder 88 is divided into a pressure chamber 56a and a working chamber 56b. The pressure chamber contains a variable volume of secondary pressure modulating fluid 74”, which is in fluid communication with the vacuum outlet 60, vacuum inlet 58, and vent inlet 62. The working chamber contains a primary pressure modulating fluid 74’, which is fluidly isolated from the vacuum outlet 60, vacuum inlet 58, and vent inlet 62. Therefore, it can be understood that the diaphragm 66c sterilely seals the primary pressure modulating fluid 74’ contained in the working chamber 56b of the manifold 56 from the secondary pressure modulating fluid 74” contained in the pressure chamber 56a of the manifold 56, thereby preventing cross-contamination between the pressure chamber 56a and the working chamber 56b.

[0124] The suction modulation device 30b also includes an actuator 68b (e.g., a voice coil) comprising the previously mentioned actuator housing 80 and a piston shaft 90 mechanically coupling a piston 66b to the actuator housing 80. The actuator housing 80, piston shaft 90, and piston 66b are housed within a top housing portion 72a. Piston 66b is fluidly coupled to a diaphragm 66c via a primary pressure modulation fluid 74' housed within a working chamber 56b of a lower, enlarged-diameter cylinder 88. Therefore, by reciprocating the piston 66b from its nominal position toward and away from the diaphragm 66c, the volume of the primary pressure regulating fluid 74' can be reciprocated, thereby reciprocating the fluid pressure within the working chamber 56b. This causes the diaphragm 66c to reciprocate from its nominal flexed state toward and away from the bottom wall 76 of the bottom housing portion 72b, thereby reciprocating the volume of the secondary pressure regulating fluid 74', and thus reciprocating the fluid pressure within the pressure chamber 56a. It is worth noting that the arrangement of the piston 66b (i.e., the primary pressure transducer) within the upper diameter-reducing cylinder 86 and the arrangement of the diaphragm 66c within the lower diameter-increasing cylinder 88 provide indirect force amplification between the piston 66b and the diaphragm 66c. It should be understood that although indirect force amplification is performed hydraulically in the suction regulating device 30b, force amplification can also be performed directly or indirectly using other methods (including pneumatic or mechanical methods).

[0125] like Figure 8A As shown, the piston shaft 90 is in a nominal position relative to the actuator housing 80, such that the piston 66b is in a nominal position relative to the upper diameter-reduced cylinder 86, and the working chamber 56b has a nominal volume of primary pressure modulating fluid 74', such that the diaphragm 66c is in a nominal flexed state relative to the bottom wall 76 of the housing 72, and the pressure chamber 56a has a nominal volume of secondary pressure modulating fluid 74' at a nominal pressure (in this case, at the baseline vacuum pressure).

[0126] like Figure 8B As shown, when the piston shaft 90 linearly translates away from the actuator housing 80 from its nominal position (downward as indicated by the arrow), the piston 66b linearly translates towards the diaphragm 66c from its nominal position, thereby reducing the volume of the primary pressure modulating fluid 74' in the working chamber 56b and thus increasing its pressure. Conversely, the increased pressure of the primary pressure modulating fluid 74' in the working chamber 56b of the cylinder 88 with its increased lower diameter causes the diaphragm 66c to flex from its nominal flexed state toward the bottom wall 76 of the housing 72, thereby reducing the variable volume of the secondary pressure modulating fluid 74" in the pressure chamber 56a, and consequently increasing the fluid pressure in the pressure chamber 56a from the baseline vacuum pressure.

[0127] On the contrary, such as Figure 8CAs shown, when the piston shaft 90 is linearly translated from its nominal position toward the actuator housing 80 (upward as indicated by the arrow), the piston 66b is linearly translated away from the diaphragm 66c from its nominal position, thereby increasing the volume of the primary pressure modulating fluid 74' in the working chamber 56b and thus reducing its pressure. Conversely, the pressure reduction of the primary pressure modulating fluid 74' in the working chamber 56b causes the diaphragm 66c to flex away from the bottom wall 76 of the housing 72 from its nominal flex state, thereby increasing the variable volume of the secondary pressure modulating fluid 74" in the pressure chamber 56a, which in turn causes the fluid pressure in the pressure chamber 56a to decrease accordingly from the baseline vacuum pressure.

[0128] In relation to the above text Figures 7A-7C In the same manner described for the suction modulation device 30a, the bottom housing portion 72b is removably coupled to the top housing portion 72a. However, in this case, there is no mechanical coupling between the actuator 68b and the diaphragm 66c. Therefore, after use, the bottom housing portion 72b, including the diaphragm 66c and vacuum inlet 58 (and vacuum flow control element 54), vacuum outlet 60 and vent inlet 62 (and fluid refill control element 52), can be removed from and discarded from the top housing portion 72a. Thus, the top housing portion 72a, including its internal components, can be reused by replacing the discarded bottom housing portion 72b with a new bottom housing portion 72b, which includes a new diaphragm 66c, vacuum inlet 58 (and vacuum flow control element 54), vacuum outlet 60, and vent inlet 62 (and fluid refill control element 52) ​​for subsequent use. Alternatively, the bottom housing portion 72b (including its contents) can be removed from the top housing portion 72a, resterilized, and reattached to the top housing portion 72a. In this way, the top housing portion 72a, as well as the more sensitive electronic components (which are aseptically isolated from the secondary pressure-modulated fluid 74” contained in the sterile bottom housing portion 72b via the diaphragm 66c), do not need to be sterilized, thereby preventing thermal damage to the electronic components and / or eliminating the need for designing more expensive electronic components that can withstand one or more thermal cycles used in a typical sterilization process.

[0129] In an alternative embodiment, the actuator may be in the form of a pneumatic or hydraulic actuator. For example, the actuator may take the form of a valve system comprising a high-pressure valve (not shown) and a low-pressure valve (not shown) in fluid communication with the working chamber of the manifold. The high-pressure and low-pressure valves can be selectively opened and closed to alternately pressurize and depressurize the working chamber, thereby alternately flexing the diaphragm toward and away from the bottom wall of the housing to alternately reduce and increase the variable volume of the pressure-modulating fluid in the pressure chamber, thereby correspondingly increasing and decreasing the fluid pressure in the pressure chamber relative to the baseline vacuum pressure.

[0130] Now for reference Figures 9A to 9G This will describe yet another specific embodiment of the suction modulation device 30c. The suction modulation device 30c is similar to the one described above. Figures 7A-7C The described modulation device 30a differs in that the suction modulation device 30c does not include a single fluid pressure oscillator 50a, but rather a pair of fluid pressure oscillators 50a' and 50a'". The fluid pressure oscillators 50a' and 50a'" each include a pair of pressure transducer elements 66a' and 66a" (in this case, a pair of opposing diaphragms), a pair of actuators 68a' and 68a'", and a pair of drivers 70' and 70'", which are respectively connected to... Figures 7A-7C The pressure transducer 66a, actuator 68a and driver 70 shown are the same.

[0131] The housing 72 is a three-part housing comprising a top housing portion 72a, a bottom housing portion 72b, and a central housing portion 72c, which are removably coupled to each other. The controller / processor 44, driver 70', and actuator housing 80 of actuator 68a' are contained within the top housing portion 72a, while the lever 82 of actuator 68a' is contained within the central housing portion 72c. Similarly, the driver 70' and actuator housing 80 of actuator 68a' are contained within the bottom housing portion 72b, while the lever 82 of actuator 68a' is contained within the central housing portion 72c. In the illustrated embodiment, the controller / processor 44 is contained within the top housing portion 72a, and UI 42 (not shown) is fixed to the exterior of the top housing portion 72a; however, in alternative embodiments, the controller / processor 44 (or any part thereof) may be contained within the bottom housing portion 72b, and UI 42 may be fixed to the exterior of the bottom housing portion 72b.

[0132] The central housing portion 72c at least partially forms a pressure manifold 46, wherein a manifold cavity 56 is formed within the central housing portion 72c, and a vacuum inlet 58, a vacuum outlet 60 together with a vacuum flow control element 54, and a vent inlet 62 together with a fluid refill control element 52 are fixed to the central housing portion 72c and in fluid communication with the manifold cavity 56. A pressure chamber 56a of the manifold cavity 56 is formed between opposing diaphragms 66a' and 66a', and this pressure chamber contains a variable volume pressure-modulated fluid 74 in fluid communication with the vacuum outlet 60, the vacuum inlet 58, and the vent inlet 62, while a working chamber 56b of the manifold cavity 56 is formed outside the opposing diaphragms 66a' and 66a', and this working chamber is fluidly isolated from the vacuum outlet 60, the vacuum inlet 58, and the vent inlet 62. The pressure chamber 56a of the manifold 56 is defined by the sidewall 78 of the central housing portion 72c and the opposing diaphragms 66a', 66a'". Therefore, it can be understood that the diaphragms 66a', 66a' aseptically seal and isolate the working chamber 56b of the manifold 56 from the pressure-modulated fluid 74 contained in the pressure chamber 56a of the manifold 56, thereby preventing cross-contamination between the pressure chamber 56a and the working chamber 56b.

[0133] In relation to the above Figures 7A-7C In the same manner as the actuator 68a of the suction modulation device 30a shown, each of the actuators 68a' and 68a'" is a linear actuator (e.g., a voice coil), comprising an actuator housing 80 and a rod 82, which is directly mechanically coupled to the corresponding diaphragm 66a' and 66a'" via a coupler 84. In this way, the variable fluid volume of the manifold cavity 56 can be reciprocated simultaneously but independently by the diaphragms 66a' and 66a'". That is, the diaphragms 66a' and 66a'" can be translated relative to each other at any position.

[0134] For example, such as Figure 9A As shown, the two rods 82 are in the nominal position relative to the actuator housing 80 of the respective actuators 68a', 68a" such that the diaphragms 66a', 66a" are in a state of flexure relative to each other, and the pressure chamber 56a has a nominal fluid volume at the nominal pressure (in this case, at the baseline vacuum pressure).

[0135] like Figure 9BAs shown, when the rod 82 of the first actuator 68a' is linearly translated away from its nominal position away from the actuator housing 80 of the first actuator 68a' (as indicated by the downward arrow), while the rod 82 of the second actuator 68a" remains in its nominal position relative to the actuator housing 80 of the second actuator 68a" and thus the diaphragm 66a' flexes toward the diaphragm 66a" as a result, the variable volume of the pressure modulating fluid 74 in the pressure chamber 56a of the manifold 56 decreases, and therefore the fluid pressure in the pressure chamber 56a of the manifold 56 increases accordingly from the baseline vacuum pressure.

[0136] like Figure 9C As shown, when the rod 82 of the second actuator 68a” is linearly translated away from its nominal position away from the actuator housing 80 of the second actuator 68a” (upward as indicated by the arrow), while the rod 82 of the first actuator 68a’ remains in its nominal position relative to the actuator housing 80 of the first actuator 68a’, thereby causing the diaphragm 66a” to flex toward the diaphragm 66a’, the variable volume of the pressure modulating fluid 74 in the pressure chamber 56a of the manifold 56 decreases, and thus the fluid pressure in the pressure chamber 56a of the manifold 56 increases accordingly from the baseline vacuum pressure.

[0137] like Figure 9D As shown, when the rod 82 of the first actuator 68a' is linearly translated away from its nominal position away from the actuator housing 80 of the first actuator 68a' (downward as indicated by the arrow), and the rod 82 of the second actuator 68a" is linearly translated away from its nominal position away from the actuator housing 80 of the second actuator 68a (upward as indicated by the arrow), thus causing the diaphragms 66a' and 66a" to flex toward each other, the variable volume of the pressure modulating fluid 74 in the pressure chamber 56a of the manifold 56 decreases, and therefore the fluid pressure in the pressure chamber 56a of the manifold 56 increases accordingly from the baseline vacuum pressure. It should be understood that because both diaphragms 66a' and 66a" flex toward each other, the fluid pressure in the pressure chamber 56a of the manifold 56 is relatively higher than... Figures 9B-9C In the configuration shown, the fluid pressure within the pressure chamber 56a of the manifold cavity 56 increases more significantly from the baseline vacuum pressure; Figures 9B-9C In the configuration, only one of the diaphragms 66a' and 66a' is flexed toward the other of the diaphragms 66a' and 66a'.

[0138] like Figure 9EAs shown, when the rod 82 of the first actuator 68a' is linearly translated from its nominal position toward the actuator housing 80 of the first actuator 68a' (upward as indicated by the arrow), while the rod 82 of the second actuator 68a' remains in its nominal position relative to the actuator housing 80 of the second actuator 68a', thereby causing the diaphragm 66a' to flex away from the diaphragm 66a', the variable volume of the pressure modulating fluid 74 in the pressure chamber 56a of the manifold 56 increases, and therefore the fluid pressure in the pressure chamber 56a of the manifold 56 decreases accordingly from the baseline vacuum pressure.

[0139] like Figure 9F As shown, when the rod 82 of the second actuator 68a” is linearly translated (downward as indicated by the arrow) from its nominal position toward the actuator housing 80 of the second actuator 68a”, while the rod 82 of the first actuator 68a’ remains in its nominal position relative to the actuator housing 80 of the first actuator 68a’, the diaphragm 66a” flexes away from the diaphragm 66a’, the variable volume of the pressure modulating fluid 74 in the pressure chamber 56a of the manifold 56 increases, and thus the fluid pressure in the pressure chamber 56a of the manifold 56 decreases accordingly from the baseline vacuum pressure.

[0140] like Figure 9G As shown, when the rod 82 of the first actuator 68a' is linearly translated from its nominal position toward the actuator housing 80 of the first actuator 68a' (upward as indicated by the arrow), and the rod 82 of the second actuator 68a" is linearly translated from its nominal position toward the actuator housing 80 of the second actuator 68a (downward as indicated by the arrow), the diaphragms 66a' and 66a" flex away from each other, increasing the variable volume of the pressure modulating fluid 74 in the pressure chamber 56a of the manifold 56. Consequently, the fluid pressure in the pressure chamber 56a of the manifold 56 decreases from the baseline vacuum pressure. It should be understood that because the two diaphragms 66a' and 66a" flex away from each other, the fluid pressure in the pressure chamber 56a of the manifold 56 decreases compared to the baseline vacuum pressure. Figures 9E-9F In the configuration shown, the fluid pressure within the pressure chamber 56a of the manifold cavity 56 decreases more significantly from the baseline vacuum pressure; Figures 9E-9F In the configuration, only one of the diaphragms 66a' and 66a' is flexed away from the other of the diaphragms 66a' and 66a'.

[0141] It should be understood that, despite Figures 9A-9GOnly seven different combinations of flexure states are shown, but the levers 82 of actuators 68a' and 68a'" can be linearly translated from their nominal positions to any independent position. Therefore, the diaphragms 66a' and 66a'" of actuators 68a' and 68a'" can flex from their relative flexure states to any relative flexure state. In this way, the two fluid pressure oscillators 50a' and 50a'" can generate more complex modulated pressure waveforms (e.g., by extending the pressure range, providing additional pressure amplitude levels, customizing frequency components, providing additional oscillation frequency components, etc.) that would otherwise only be achievable by a single, more expensive high-speed / high-acceleration / high-precision fluid pressure oscillator. That is, instead of a single fluid pressure oscillator requiring the generation of complex modulated pressure waveforms, the complexity of the modulated pressure waveform is distributed between the two fluid pressure oscillators working in tandem, allowing each fluid pressure oscillator to have a less complex motion sequence required to generate the complex modulated pressure waveform. Therefore, the combination of two fluid pressure oscillators is not only more dynamically robust in generating complex modulated pressure waveforms, but the fluid pressure oscillators can also include simpler, more cost-effective actuators. Although the suction modulation device 30a is shown and described as comprising only two fluid pressure oscillators, it should be understood that alternative embodiments of the suction modulation device may have more than two fluid pressure oscillators to produce even more complex modulated pressure waveforms. The multiple fluid pressure oscillators of such a suction modulation device may be arranged in a linear array, a circular array, or a combination thereof (e.g., two pairs of fluid pressure oscillators arranged in a line).

[0142] It is worth noting that, with Figures 7A-7CIn the fluid pressure oscillator 50a shown, the coupler 84 detachably couples the rod 82 to the diaphragm 66a in the same way that the rods 82 of the respective actuators 68a', 68a" can be easily coupled to the diaphragms 66a', 66a" . As described above, the top and bottom housing portions 72a, 72b contain the more expensive components (in this case, electronics) of the suction modulation device 30c, including UI 42, controller / processor 44, actuators 68a', 68a" , and drivers 70', 70" , while the central housing portion 72c contains the cheaper components (in this case, passive components), including the diaphragms 66a', 66a" , vacuum inlet 58, vacuum outlet 60 (along with vacuum flow control element 54), and vent inlet 62 (along with fluid refill control element 52). Because the top and bottom housing portions 72a, 72b are detachably coupled to the central housing portion 72c The actuators 68a', 68a" have rods 82 detachably coupled to diaphragms 66a', 66a" so that the top and bottom housing portions 72a, 72b can be made reusable, while the central housing portion 72c and its contents can be made disposable. That is, after use, the top and bottom housing portions 72a, 72b (including diaphragms 66a', 66a" and vacuum inlet 58 (and vacuum flow control element 54), vacuum outlet 60 and vent inlet 62 (and The fluid refill control element 52 can be removed and discarded from the central housing portion 72c and replaced with new top and bottom housing portions 72a, 72b (including new diaphragms 66a', 66a'"), vacuum inlet 58 (and vacuum flow control element 54), vacuum outlet 60, and vent inlet 62 (and fluid refill control element 52)) for subsequent use. Alternatively, the top and bottom housing portions 72a, 72b (including their contents) can be removed from the central housing portion 72c, resterilized, and reattached to the central housing portion 72c. In this way, the top and bottom housing portions 72a, 72b, as well as the more sensitive electronic components (which are aseptically isolated from the pressure-modulated fluid 74 contained in the sterile central housing portion 72c by diaphragms 66a', 66a'), do not need to be sterilized, thereby preventing thermal damage to the electronic components and / or eliminating the need for designing more expensive electronic components that can withstand one or more thermal cycles used in typical sterilization processes.

[0143] Although the fluid pressure oscillators 50a', 50a" are shown and described as comprising a pair of pressure transducer elements 66a', 66a (in this case, a pair of opposing diaphragms) and a pair of actuators 68a', 68a" respectively, they are respectively connected to Figures 7A-7C The pressure transducer 66a and actuator 68a shown are identical, but it should be understood that one or both of the fluid pressure oscillators in alternative embodiments of the suction modulation device may be compatible with... Figure 9A- The difference is shown in Figure 9M. For example, instead of having a directly driven diaphragm assembly, one or both of the fluid pressure oscillators can have an indirectly driven diaphragm assembly, such as... Figures 8A-8C The diaphragm-based component shown, or any other diaphragm-based component sufficient to cause the variable fluid volume of the manifold cavity 56 to oscillate, can oscillate independently of the diaphragm.

[0144] Now for reference Figures 10A to 10C and Figures 11A to 11C This section will describe another specific embodiment of the suction modulation device 30d. The suction modulation device 30d typically includes a main unit 92, a slave unit 94, and a flexible fluid conduit 96 that fluidly couples the slave unit 94 to the main unit 92.

[0145] Except that main unit 92 does not include a pressure manifold, main unit 92 is similar to Figures 7A-7C The suction modulation device 30a is shown in the diagram. Conversely, the main unit 92 includes a cavity 56' having a primary pressure chamber 56a' and an output modulation port 98' in fluid communication with the primary pressure chamber 56a', one end of which is fixed to the output modulation port. The slave unit 94 includes a pressure manifold 46 having a secondary pressure chamber 56a'" and an input modulation port 98' in fluid communication with the secondary pressure chamber 56a', the other end of which is fixed to the input modulation port. The pressure manifold 46 also includes a vacuum inlet 58, a vacuum outlet 60, a vacuum flow control element 54, a vent inlet 62 (with a fluid line), and a fluid refill control element 52. As will be described in further detail below, the entire main unit 92 may be reusable, while the entire slave unit 94 may be disposable.

[0146] Similar to the suction modulation device 30a, the main unit 92 includes a housing or outer shell 72' that houses the controller / processor 44, and UI 42 is fixed thereto. The slave unit 94 includes a housing or outer shell 72'' that forms a pressure manifold 46 with a secondary pressure chamber 56a'', as well as a vacuum inlet 58, a vacuum outlet 60, a vent inlet 62, a fluid refill control element 52, and a vacuum flow control element 54. In the illustrated embodiment, the housing 72' of the main unit 92 is a two-part housing comprising a top housing portion 72a' and a bottom housing portion 72b' that are detachably coupled to each other. A sensor (not shown) is fixed to the housing 72'' of the slave unit 94 and is in fluid communication with the secondary pressure chamber 56a''.

[0147] exist Figures 10A-10C and 11A- Figure 11CIn the illustrated embodiment, the suction modulation device 30d includes a fluid pressure oscillator 50c, which is a two-part driven diaphragm assembly. Specifically, the fluid pressure oscillator 50c includes a primary pressure transducer 66d and a secondary pressure transducer 66e, wherein the primary pressure transducer is a diaphragm fixed within the cavity 56' of the main unit 92, and the secondary pressure transducer is a diaphragm fixed within the manifold cavity 56" of the slave unit 94 (e.g., Figures 11A-11C (As best shown). Diaphragm 66d divides the cavity 56' of main unit 92 into a primary pressure chamber 56a' and a main working chamber 56b'. The primary pressure chamber contains a variable volume of primary pressure modulation fluid 74' in fluid communication with the output modulation port 98', while the main working chamber is fluidly isolated from the output modulation port 98'. The primary pressure chamber 56a' of cavity 56' is defined by the bottom wall 76 and side walls 78 of housing 72' and the opposing diaphragm 66d.

[0148] The diaphragm 66e divides the manifold cavity 56” of unit 94 into a secondary pressure chamber 56a” and a secondary working chamber 56b”. The secondary pressure chamber contains a variable volume of secondary pressure modulating fluid 74” which is in fluid communication with the vacuum outlet 60, vacuum inlet 58 and vent inlet 62. The secondary working chamber contains a primary pressure modulating fluid 74' which is fluidly isolated from the vacuum outlet 60, vacuum inlet 58 and vent inlet 62. Therefore, it is understood that the diaphragm 66e sterilely seals and isolates the primary pressure regulating fluid 74' contained in the primary pressure chamber 56a', fluid line 96, and secondary working chamber 56b” of the main unit 92 from the secondary pressure regulating fluid 74” contained in the secondary pressure chamber 56a” of the secondary unit 94, thereby preventing cross-contamination between the secondary pressure chamber 56a” and the primary pressure chamber 56a', fluid line 96, and secondary working chamber 56b”. A sterile cover (not shown) may be used to encapsulate the main unit 92, allowing the entire suction modulation device 30d to be used in a sterile area.

[0149] The fluid pressure oscillator 50c also includes a linear actuator 68a (e.g., a voice coil), which includes an actuator housing 80 and a rod 82 directly and mechanically coupled to the diaphragm 66d via a coupler 84. The actuator housing 80 is contained within a top housing portion 72a', while the rod 82 is disposed in a bottom housing portion 72b'. The diaphragm 66d of the main unit 92 is fluidly coupled to the diaphragm 66e of the secondary unit 94 via primary pressure modulating fluid 74' contained in the primary pressure chamber 56a' of the main unit 92 and primary pressure modulating fluid 74' contained in the fluid lines 96 and the secondary working chamber 56b' of the unit 94.

[0150] Therefore, by reciprocating the rod 82 from its nominal position away from and toward the actuator housing 80, the diaphragm 66d can reciprocate from its nominal flexed state toward and away from the bottom wall 76 of the housing 72' of the main unit 92, thereby reciprocatingly oscillating the volume of the primary pressure modulating fluid 74', and thus reciprocatingly oscillating the fluid pressure within the primary pressure chamber 56a' of the main unit 92. Conversely, the volume and fluid pressure of the primary pressure modulating fluid 74' within the working chamber 56b" of the unit 92 can reciprocately oscillate, thereby causing the diaphragm 66e to reciprocate from its nominal flexed state toward and away from the bottom wall 76 of the housing 72" of the unit 94, thereby reciprocatingly oscillating the volume of the secondary pressure modulating fluid 74", and thus reciprocatingly oscillating the fluid pressure within the secondary pressure chamber 56a" of the unit 94.

[0151] like Figure 10A As shown, rod 82 is in the nominal position relative to actuator housing 80, such that diaphragm 66d is in the nominal flexural state relative to bottom wall 76 of housing 72', and the primary pressure chamber 56a' of main unit 92 and the working chamber 56b" of slave unit 94 have a nominal volume of primary pressure modulated fluid 74' at nominal pressure. Therefore, as Figure 11A As shown, the diaphragm 66e is in a nominal flexed state relative to the bottom wall 76 of the housing 72”, and has a nominal volume of secondary pressure modulated fluid 74 at a nominal pressure (in this case, at the baseline vacuum pressure) from the secondary pressure chamber 56a” of the unit 92”.

[0152] like Figure 10B As shown, when rod 82 moves linearly away from actuator housing 80 from its nominal position (downward as indicated by the arrow), diaphragm 66d flexes from its nominal flexed state toward the bottom wall 76 of housing 72' of main unit 92, thereby reducing the volume of primary pressure regulating fluid 74', and consequently increasing the fluid pressure in primary pressure chamber 56a' of main unit 92, fluid line 96, and working chamber 56b" of unit 94 from the baseline vacuum pressure. Furthermore, as... Figure 11B As shown, the increased pressure of the primary pressure modulating fluid 74' in the working chamber 56b” of unit 94 causes the diaphragm 66e to flex from its nominal flexed state toward the bottom wall 76 of the housing 72” of unit 94, thereby reducing the variable volume of the secondary pressure modulating fluid 74” in the secondary pressure chamber 56a”, and consequently increasing the fluid pressure in the secondary pressure chamber 56a” from the baseline vacuum pressure.

[0153] In comparison, such as Figure 10CAs shown, when rod 82 is linearly translated from its nominal position toward actuator housing 80 (upward as indicated by the arrow), diaphragm 66d flexes away from the bottom wall 76 of housing 72' of main unit 92 from its nominal flex state, thereby increasing the volume of primary pressure regulating fluid 74', and consequently reducing the fluid pressure in primary pressure chamber 56a' of main unit 92, fluid line 96, and working chamber 56b" of unit 94 from the baseline vacuum pressure. Furthermore, as... Figure 11C As shown, the reduced pressure of the primary pressure modulating fluid 74' in the working chamber 56b” of unit 94 causes the diaphragm 66e to flex away from its nominal flexural state from the bottom wall 76 of the housing 72” of unit 94, thereby increasing the variable volume of the secondary pressure modulating fluid 74” in the secondary pressure chamber 56a”, and consequently reducing the fluid pressure in the secondary pressure chamber 56a” from the baseline vacuum pressure accordingly.

[0154] Advantageously, the slave unit 94 is removably coupled to the master unit 92 via fluid conduit 96, allowing the master unit 92 to be made reusable while the slave unit 94 can be made disposable. That is, after use, the entire slave unit 94 and fluid conduit 96 can be disconnected from the master unit 92 and discarded, and replaced with a new slave unit 92 and fluid conduit 96 for subsequent use. Alternatively, the slave unit 94 can be disconnected from the master unit 92, re-sterilized, and reconnected to the master unit 92 via a new fluid conduit 96. In this way, the master unit 94, as well as the more sensitive electronic components (which are aseptically isolated via diaphragm 66e from the secondary pressure modulated fluid 74” contained in the sterile secondary pressure chamber 56a” of the slave unit 94), do not need to be sterilized, thus preventing thermal damage to the electronic components and / or eliminating the need to design more expensive electronic components that can withstand one or more thermal cycles used during a typical sterilization procedure.

[0155] Although the fluid pressure oscillator 50a is shown and described as including respectively with Figures 7A-7C The pressure transducer 66a and actuator 68a shown are of the same diaphragm type as the pressure transducer 66d and actuator 68a, but it should be understood that the fluid pressure oscillator in an alternative embodiment of the suction modulation device can be... Figures 10A-10C The differences are illustrated. For example, instead of having a directly driven diaphragm assembly, a fluid pressure oscillator can have an indirectly driven diaphragm assembly, such as... Figures 8A-8CThis can be any other diaphragm-based assembly, as shown, or with sufficient capacity to contain secondary pressure modulating fluid 74” within the sterile secondary pressure chamber 56a” of the slave unit 94 via diaphragm 66e oscillation. For example, the diaphragm-based assembly could be a pneumatically or hydraulically driven diaphragm assembly; that is, a valve system with a pneumatic actuator could be incorporated into the master unit. In this case, the entire cavity 56' of the master unit 92 would serve as the working chamber, through which air from the high-pressure and low-pressure valves would be delivered via fluid lines 96 to the working chamber 56b” of the slave unit 94, thereby alternately flexing the diaphragm 66e toward and away from the bottom wall 76 of the housing 72” of the slave unit 94 to alternately decrease and increase the variable volume of the pressure modulating fluid 74” in the pressure chamber 56a”, thereby causing the fluid pressure in the pressure chamber 56a” to increase and decrease accordingly from the baseline vacuum pressure.

[0156] Now for reference Figures 12 to 13 This will describe yet another specific embodiment of the suction modulation device 30e. The suction modulation device 30e is similar to... Figures 10A-10C and 11A- Figure 11C The suction modulation device 30d shown is similar to the suction modulation device 30e, which typically includes a master unit 92' and a slave unit 94'. However, unlike the distribution of fluid components between the master unit 92' and the slave unit 94' and their fluid connection via fluid lines, the master unit 92' includes only a housing or enclosure 72' housing the electronic components of the suction modulation device, such as UI 42, controller / processor 44. Figures 12-13 The driver 70 (not shown in the image) Figures 12-13 (not shown in the image), while unit 94' includes a housing or enclosure 72" that carries all fluid and mechanical components of the suction regulating device, such as pressure transducer 66 and actuator 68, and pressure manifold 46, including vacuum inlet 58, vacuum outlet 60 (together with vacuum flow control element 54). Figures 12-13 (not shown in the image) and vent inlet 62 (together with fluid refill control element 52) Figures 12-13 (Not shown in the text). The fluid pressure oscillator 50 may take the form of, for example, any of the fluid pressure oscillators 50a and 50b described herein. In the illustrated embodiment, the master unit 92' takes the form of an insert that can be arranged within the slave unit 94', such that an electrical connection is established between the master unit 92' and the slave unit 94'. For example, the slave unit 94' may have a housing or enclosure 72 having space for inserting the master unit 92'. The slave unit 94' may also have a cover 99 that can be closed once the master unit 92' is inserted into the slave unit 94', to provide an integrated and compact unit. In an alternative embodiment, the master unit 92' is not physically connected to the slave unit 94' to provide an electrical connection between them, but remains remote from the slave unit 94' and wirelessly communicates with it.

[0157] and Figures 10A-10C and Figures 11A-11C In the suction regulating device 30d shown, the slave unit 94 is removably coupled to the main unit 92, thus making the main unit 92 reusable while the slave unit 94 is disposable. Figures 12-13 In the suction adjustment device 30e shown, the master unit 92' can be removed from the slave unit 94', so that the slave unit 94' without the master unit 92' can be discarded. The master unit 92' can then be inserted into a new slave unit 94' for subsequent use.

[0158] Now for reference Figures 14A-14C An embodiment of the suction pulse device 30f will be described. The suction pulse device 30f is similar to the suction modulation devices 30a-30e described above in that it includes a pressure manifold 46, which includes a manifold body 56 having a pressure chamber 56a and a working chamber 56b, configured to direct the suction catheter 22 ( Figure 3 (As shown) fluid is coupled to the vacuum inlet 58 of the pressure chamber 56a, and is configured to connect the vacuum source 24 ( Figure 3 (As shown in the diagram) The fluid is coupled to the vacuum outlet 60 of the pressure chamber 56a. Similar to the suction modulation devices 30a-30e described above, the suction modulation device 30f also includes a diaphragm 66f fixed within the manifold cavity 56 for fluid isolation between the pressure chamber 56a and the working chamber 56b, and is configured to transmit the blockage clearance pressure to the suction fluid 74 contained in the pressure chamber 56a.

[0159] The aspiration pulse device 30f offers the same advantages as the aforementioned aspiration modulation devices 30a-30e, namely, that the diaphragm 66f aseptically seals and isolates the working chamber 56b from the aspiration fluid 74 contained in the pressure chamber 56a of the manifold 56, thereby preventing cross-contamination between the pressure chamber 56a and the working chamber 56b. Furthermore, the aspiration pulse device 30f can transmit blockage clearance pressure through the aspiration chamber 34 of the aspiration catheter 22 without using any saline solution. Therefore, not only is a connection to a saline source unnecessary, but there is also no mixing of saline solution with the tissue removed from the patient, allowing the entire capacity of the aspiration collection container 28 to be used for storing this removed tissue, and allowing for rapid examination of the aspiration collection container 28 to determine the nature and amount of this removed tissue. Furthermore, similar to the previously described suction modulation devices 30a-30e, the suction pulse device 30f does not require a check valve between the vacuum source 24 and the pressure chamber 56a because the working chamber 56b of the manifold cavity 56 is isolated from the suction fluid 74 contained in the pressure chamber 56a.

[0160] However, unlike the previously described aspiration modulation devices 30a-30e, the diaphragm 66f does not modulate the vacuum pressure applied by the vacuum source 24 to the pressure chamber 56a. Instead, in response to different pressures within the working chamber 56b, it decouples the vacuum source 24 from the fluid in the pressure chamber 56a and then applies a blockage-clearing pressure in the form of pressure pulses or pulse sequences to the aspiration fluid 74 contained in the pressure chamber 56a to facilitate the subsequent uptake of the thrombus from the blockage aspiration catheter 22. Once the pressure pulse is complete, the diaphragm 66f fluidly recouples the vacuum source 24 back to the pressure chamber 56a to draw the thrombus into the aspiration catheter 22.

[0161] For this purpose, the pressure manifold 46 also includes an additional pressure port 64, which is configured for connecting pressure control devices ( Figures 14A-14C (Not shown in the image) fluidly coupled to the working chamber 56b. A pressure control device can apply various levels of pressure to the working fluid 74' contained in the working chamber 56b to displace the diaphragm 66f from the suction state (see [link to image]). Figure 14A Switch to pulse state (see) Figures 14B-14C When in its aspiration state, diaphragm 66f fluidly couples vacuum source 24 to pressure chamber 56a to provide vacuum pressure to pressure chamber 56a for normal aspiration via aspiration conduit 22. In contrast, when in its pulsating state, diaphragm 66f decouples vacuum source 24 from pressure chamber 56a to suspend normal aspiration through aspiration conduit 22, thereby pressure-couples working chamber 56b to pressure chamber 56a in a dedicated manner (i.e., unaffected by vacuum source 24) and applies pressure to the aspiration fluid 74 contained in pressure chamber 56a in an attempt to agitate any thrombus obstructing aspiration conduit 22. Once the thrombus is cleared from aspiration conduit 22, the pressure control device continuously applies an appropriate low level of pressure to the working fluid 74 contained in working chamber 56b to disengage diaphragm 66f from its pulsating state (see [link to relevant documentation]). Figures 14B-14C Switch back to and remain in its suction state (see...) Figure 14A This fluidly recouples the vacuum source 24 to the pressure chamber 56a to provide vacuum pressure to the pressure chamber 56a and returns it to normal suction (reset vacuum pressure) via the suction conduit 22.

[0162] Specifically, the diaphragm 66f includes a circular central sealing region 67 aligned with the vacuum outlet 60 (in Figure 15A and Figure 15B(Best shown in the diagram). Vacuum outlet 60 protrudes toward diaphragm 66f into pressure chamber 56a (in this case, protruding upward from the bottom of pressure manifold 46 into pressure chamber 56a) to facilitate interaction between the circular central sealing region 67 of diaphragm 66f and vacuum outlet 60, specifically sealing vacuum outlet 60 when diaphragm 66f is in its sealed state and releasing the seal on vacuum outlet 60 when diaphragm 66f is in its suction state, as will be described in further detail below. Diaphragm 66f may optionally include an annular protrusion (or O-ring) 69 that contacts and seals vacuum outlet 67. As will be described in further detail below, diaphragm 66f also includes an annular pulse region 71 located between vacuum outlet 60 and the inner surface of manifold cavity 56 (in the diagram). Figure 15A and 15B (best shown in the diagram) to facilitate unimpeded deflection of the annular pulse region 71 of the diaphragm 66f when the diaphragm 66f is in its sealing pulse state. Preferably, the diaphragm 66f has a biasing force (e.g., using one or more springs (not shown) or by means of a passive restoring force) that pushes the diaphragm 66f from its pulse state to its suction state.

[0163] When the pressure control device applies a relatively low pressure to the working fluid 74' contained in the working chamber 56b, maintaining a pressure below the sealing pressure threshold (e.g., making the fluid pressure difference between the working chamber 56b and the pressure chamber 56a negative, zero, or slightly positive but insufficient to overcome the bias force applied to the diaphragm 66f or the bias force inherent in the diaphragm 66f itself), the diaphragm 66f will remain in its suction state (e.g., Figure 14A (as shown), to maintain fluid coupling between vacuum source 24 and pressure chamber 56a, so that normal suction through suction conduit 22 can continue.

[0164] When the pressure control device applies a relatively moderate or higher pressure to the working fluid 74' contained in the working chamber 56b, exceeding the sealing pressure threshold (e.g., causing the fluid pressure difference between the working chamber 56b and the pressure chamber 56a to overcome the biasing force applied to the diaphragm 66f or the biasing force inherent in the diaphragm 66f itself), the diaphragm 66f will move toward the vacuum outlet 60 from its suction state. Figure 14A ) deflect (in this case, downwards) to its pulse state ( Figure 14B This allows the circular central sealing region 67 to contact and seal the vacuum outlet 60, thereby decoupling the vacuum source 24 from the pressure chamber 56a.

[0165] When the pressure control device applies a relatively high pressure to the working fluid 74' contained in the working chamber 56b (e.g., significantly higher than a relatively moderate pressure, but less than the patient's blood pressure, such as atmospheric pressure), the annular pulse region 71 of the diaphragm 66f will deflect (in this case, downward) into the pressure chamber, achieving its sealing pulse state. Figure 14C This applies pressure to the suction fluid 74 contained in the pressure chamber 56, and in a preferred embodiment, applies a pressure pulse output.

[0166] When the pressure control device applies a relatively low pressure again to the working fluid 74' contained in the working chamber 56b, this pressure is below the unsealing pressure threshold (e.g., such that the net force exerted on the central sealing region 67 of the diaphragm 66f by the pressure difference between the working chamber 56b and the sealed vacuum outlet 60, the net force exerted on the annular pulse region 71 of the diaphragm 66f by the pressure difference between the working chamber 56b and the pressure chamber 56a, and the bias force exerted on the diaphragm 66f or inherent to the diaphragm 66f itself are negative (i.e., towards the working chamber 56b)). The annular pulse region 71 of the diaphragm 66f will deflect (in this case, upwards) away from the pressure chamber 56a. Figure 14B ), and the diaphragm 66f will deflect further (in this case, upwards), and then from its pulse state ( Figure 14B ) transform back to its suction state ( Figure 14A This causes the circular central sealing area 67 to no longer contact and unseal the vacuum outlet 60, thereby recoupled the vacuum source 24 to the pressure chamber 56a.

[0167] It should be understood that each of the sealing pressure threshold and the unsealing pressure threshold can vary depending on whether the aspiration catheter 22 is blocked by a thrombus or whether the thrombus has been cleared.

[0168] Specifically, the vacuum pressure applied to the pressure chamber 56a by the vacuum source 24 will vary depending on the aspiration flow conditions before the diaphragm 66f transitions from its aspiration state to its pulsating state. For example, the vacuum pressure applied to the pressure chamber 56a during the no-flow state (i.e., the aspiration catheter 22 is blocked by a thrombus) will be significantly lower than the vacuum pressure applied to the pressure chamber 56a during the mixed-flow state (i.e., the aspiration catheter 22 actively takes up the thrombus), and the vacuum pressure applied to the pressure chamber 56a during the mixed-flow state will be significantly lower than the vacuum pressure applied to the pressure chamber 56a during the free-flow state (i.e., the aspiration catheter 22 only takes up body fluids). Therefore, the sealing pressure threshold during the no-flow state will be significantly lower than the sealing pressure threshold during the mixed-flow state, and the sealing pressure threshold during the mixed-flow state will be significantly lower than the sealing pressure threshold during the free-flow state. However, during normal operation, the pressure control device will operate only in response to the no-flow conditions (manual, semi-automatic, or automatic), as will be described in further detail below. In this case, the sealing pressure threshold is typically relatively low, for example, equal to or close to the vacuum pressure applied to the pressure chamber 56a by the vacuum source 24 when the aspiration catheter 22 is blocked by a thrombus, under the influence of the bias force applied to the diaphragm 66f or inherent in the diaphragm 66f itself.

[0169] Before the diaphragm 66f transitions from its pulsating state back to its suction state (i.e., the vacuum source 24 remains fluidly decoupled from the pressure chamber 56a), the pressure in the pressure chamber 56a will vary depending on whether the suction catheter 22 is blocked by a thrombus or has been cleared, as described above. Specifically, when the suction catheter 22 is blocked by a thrombus, the working chamber 56b and the pressure chamber 56b achieve a stable pressure coupling, such that the pressure in the pressure chamber 56b will vary depending on the pressure in the working chamber 56a. However, the pressure at the sealed vacuum outlet 60 will be at a very low vacuum pressure. Conversely, when the thrombus in the suction catheter 22 is cleared, the pressure in the pressure chamber 56b will be relatively high (e.g., at or near blood pressure). Therefore, the unblocking pressure threshold when the suction catheter 22 is blocked by a thrombus will be significantly lower than the unblocking pressure threshold when the suction catheter 22 is cleared of the thrombus. In practice, the release pressure threshold will be lower than the sealing pressure threshold, primarily due to the relatively low vacuum level applied by the sealed vacuum outlet 60 to the circular sealing area 67 of the diaphragm 66f. However, when normal aspiration needs to be resumed after clearing the thrombus from the aspiration catheter 22, the release pressure threshold will be at its highest value, making it easier to trigger the diaphragm 66f to switch back from its pulsating state to its aspiration state. In fact, even if the pressure in the working chamber 56b is at atmospheric pressure, it may still promote the diaphragm 66f to switch back from its pulsating state to its aspiration state. Conversely, when the aspiration catheter 22 is still blocked by a thrombus, the release pressure threshold will be at its lowest value, making it more difficult to trigger the diaphragm 66f to switch back from its pulsating state to its aspiration state. However, pulsating operation of the aspiration fluid 74' in the pressure chamber 56a is still required in this case.

[0170] Now for reference Figure 16A The diagram illustrates the pressure progression within the pressure chamber 56a and at the vacuum outlet 60 during both free flow (i.e., when the aspiration catheter 22 is free of thrombus) and no flow (i.e., when the aspiration catheter 22 is blocked by thrombus), in response to the application of an exemplary pressure waveform 73a to the working chamber 56b.

[0171] During the free-flow state, the unsealed vacuum outlet 60 and the corresponding pressure chamber 56a are at a relatively moderate free-flow vacuum pressure level. Under free-flow conditions, the exemplary pressure waveform input 73a defaults to a relatively low vacuum pressure level 75a, which is equal to or close to the no-flow vacuum pressure. It is worth noting that the low vacuum pressure level 75a applied to the pressure waveform input 73a of the working chamber 53b is much lower than the exemplary sealing pressure threshold 77a, and therefore, the diaphragm 66f will remain in the suction state to achieve normal suction.

[0172] During the flow-free period, the unsealed vacuum outlet 60 and the corresponding pressure chamber 56a decrease to a relatively low flow-free vacuum pressure level. Preferably, while or for a period of time after the pressure chamber 56a decreases to the low flow-free vacuum pressure, the pressure waveform input 73a will have a pressure pulse input 75b that rises to a relatively high pressure level (e.g., atmospheric pressure). For illustrative purposes, the pressure pulse input 75b is essentially trapezoidal, but it should be understood that the pressure pulse input 75b can have any suitable shape. As the pressure pulse input 75b rises, the unsealed vacuum outlet 60 and the corresponding pressure chamber 56a remain at a low flow-free vacuum pressure level until the pressure pulse input 75b reaches the sealing pressure threshold 77a.

[0173] Once the pressure pulse input 75b reaches or exceeds the sealing pressure threshold 77a, the diaphragm 66f will transition from its suction state to its pulsed state; that is, the vacuum source 24 will be fluidly decoupled from the pressure chamber 56a through the sealed vacuum outlet 60. As a result, the pressure chamber 56a will be firmly pressure-coupled to the working chamber 56b. Although the sealed vacuum outlet 60 will remain at a low no-flow vacuum pressure, the pressure level of the pressure chamber 56a will rapidly rise to the pressure level of the working chamber 56b and then track the pressure level of the working chamber 56b (the offset being equal to any bias force applied to the diaphragm 66f or inherent to the diaphragm 66f itself, as well as the elasticity of the diaphragm 66f). Therefore, in response to applying the pressure pulse input 75b to the working chamber 56b, the pressure pulse output 75b' will be transmitted through the diaphragm 66f or applied to the pressure chamber 56a. As the pressure pulse input 75b decreases, the pressure level in pressure chamber 56a continues to track the pressure level in working chamber 56b until the pressure pulse input 75b reaches the release pressure threshold 77b. It should be understood that the release pressure threshold 77b is lower than... Figure 16A The sealing pressure threshold 77a shown is mainly due to the force required to overcome the low vacuum pressure applied to the circular sealing area 67 of the diaphragm 66f.

[0174] Assuming the thrombus has not yet been cleared from the aspiration catheter 22, the pressure pulse input 75b will reach or fall below the unsealing pressure threshold 77b, causing the diaphragm 66f to transition from its pulsed state back to its aspiration state; that is, by unsealing the vacuum outlet 60, the vacuum source 24 will fluidly recouple to the pressure chamber 56a. As a result, the pressure level in the pressure chamber 56a will stop tracking the pressure level in the working chamber 56b and rapidly drop back to the low no-flow vacuum pressure level corresponding to the low no-flow vacuum pressure level of the vacuum outlet 60. The exemplary pressure waveform input 73a then drops to its default low vacuum pressure level 75c, after which another pressure waveform input 73a may have another pressure pulse input 75b.

[0175] In contrast, assuming that the thrombus has been cleared from the aspiration catheter 22 at some point during the pressure pulse input 75b, the pressure level in pressure chamber 56a will stop tracking the pressure level in working chamber 56b and immediately increase to or near blood pressure, causing the release pressure threshold 77b to increase above the peak value of the pressure pulse input 75b, such as... Figure 16B As shown. Since the pressure pulse input 75b will be below the unsealing pressure threshold 77b, the diaphragm 66f will transition from its pulsed state back to its suction state; that is, by unsealing the vacuum outlet 60, the vacuum source 24 will fluidly recouple to the pressure chamber 56a. As a result, the pressure level in the pressure chamber 56a will rapidly and ideally decrease from blood pressure or near blood pressure back to a moderate free-flowing vacuum pressure level corresponding to the moderate free-flowing vacuum pressure level of the vacuum outlet 60. It is worth noting that in some cases, the pressure level in the pressure chamber 56a may not robustly decrease to a moderate free-flowing vacuum pressure level, in which case the diaphragm 66f may experience oscillations between the suction and pulsed states, or the diaphragm 66f may not deflect upwards completely, causing the vacuum outlet 60 to fluidly couple to the pressure chamber 56a in a decaying manner. However, the exemplary pressure waveform input 73a will preferably subsequently decrease to its default low vacuum pressure level 75b, thereby ensuring that the diaphragm 66f remains fully and continuously in its suction state until actively triggered to transition to its pulsed state.

[0176] although Figures 16A-16B The pressure waveform input 73a shown is described as having a single (only one) pressure pulse input 75b during each pulse state of the diaphragm 66f, but in the alternative embodiment shown in Figure 17, the pressure waveform input 73a' can have a series of pressure pulse inputs 75b during each pulse state of the diaphragm 66f (in this case, three pressure pulse inputs 75b1-75b3). Specifically, once the first pressure pulse input 75b1 reaches or exceeds the sealing pressure threshold 77a, the diaphragm 66f transitions from its suction state to its pulse state to seal the vacuum outlet 60 and fluidly decouple the vacuum source 24 from the pressure chamber 56a. (The above is in response to...) Figure 16A In the same manner described, the sealed vacuum outlet 60 will be maintained at a low, flow-free vacuum pressure, while the pressure level in pressure chamber 56a will rapidly rise to and subsequently track the pressure level in working chamber 56b. Therefore, in response to applying a first pressure pulse input 75b1 to working chamber 56b, a first pressure pulse output 75b1' will be transmitted or applied to pressure chamber 56a via diaphragm 66f. As the first pressure pulse input 75b1 decreases, the pressure level in pressure chamber 56a continues to rise in accordance with the aforementioned... Figure 16AThe pressure level in the working chamber 56b is tracked in the same manner. However, the first pressure pulse input 75b1 never reaches the release pressure threshold 77b. That is, with Figure 16A The base of the single pressure pulse input 75b shown (which is below the desealing pressure threshold 77b) differs from the base of the falling edge of the first pressure pulse input 75b1, which is above the desealing pressure threshold 77b. Therefore, the diaphragm 66f will not transition from its pulsed state back to its suction state. Conversely, the pressure waveform input 73a' has a second pressure pulse input 75b2 and a third pressure pulse input 75b3 applied to the working chamber 56b, thereby transmitting or applying the second pressure pulse output 75b2' and the third pressure pulse output 75b3' to the pressure chamber 56a through the diaphragm 66f. Notably, the bases of the rising and falling edges of the second pressure pulse input 75b2 and the base of the rising edge of the third pressure pulse input 75b3 are above the desealing pressure threshold 77b; therefore, the diaphragm 66f will not transition from its pulsed state back to its suction state.

[0177] Assuming the thrombus has not yet been cleared from the aspiration catheter 22, the third pressure pulse input 75b3 will reach or decrease below the unsealing pressure threshold 77b, thereby causing the diaphragm 66f to switch from its pulsed state back to its aspiration state; that is, by unsealing the vacuum outlet 60, the vacuum source 24 will fluidly recouple to the pressure chamber 56a. Therefore, in accordance with the above regarding... Figure 16A In the same manner discussed, the pressure level of pressure chamber 56a will stop tracking the pressure level of working chamber 56b and rapidly drop back to the low no-flow vacuum pressure level corresponding to the low no-flow vacuum pressure level of vacuum outlet 60. Then, the exemplary pressure waveform input 73a drops to its default low vacuum pressure level 75b, after which pressure waveform input 73a' may have another series of pressure pulse inputs 75b1-75b3.

[0178] In contrast, assuming that the thrombus has been cleared from the aspiration catheter 22 at some point during a series of pressure pulse inputs 75b1-75b3, the pressure level in pressure chamber 56a will stop tracking the pressure level in working chamber 56b and immediately increase to or near blood pressure, causing the unblocking pressure threshold 77b to increase to a level greater than the peak value of the pressure pulse input 75b, and as described above for... Figure 16B The diaphragm 66f is triggered to transition from its pulsed state back to its suction state in the same manner as described.

[0179] The pressure control device can be any device capable of applying a waveform to the working fluid 74' contained in the working chamber 56b in a manner that switches the diaphragm 66f between a suction state and a sealing pulse state. In a preferred embodiment, the pressure control device is inherently pneumatic, in which case the working fluid 74' is a gas (e.g., air), such that the diaphragm 66f has a faster response time when the pressure control device applies various levels of pressure to the working fluid 74'. It should be noted that because the diaphragm 66f fluidly isolates the pressure chamber 56a from the working chamber 56b, any risk of gas entering the patient's bloodstream is eliminated. In an alternative embodiment, the pressure control device is inherently hydraulic, in which case the working fluid 74' is a liquid (e.g., saline). While the response time of the diaphragm 66f may be relatively slow when the working fluid 74' is a liquid (due to its higher viscosity), the initial pulse spike may be higher due to its incompressibility, compared to the lower initial pulse spike with stronger oscillations produced when using a more compressible gas.

[0180] exist Figure 17A In one embodiment shown, the pressure control device 25' includes a controller 45 and a three-way valve 47 having two input ports 49a and 49b connected to a high-pressure source (e.g., atmosphere) and a low-pressure source (e.g., a vacuum provided by a vacuum source preferably different from vacuum source 24), respectively, and an output port 49c connected to the pressure port 64 of the pressure manifold 46. The controller 45 is configured to operate the three-way valve 47 (e.g., via a solenoid (not shown)) to fluidly couple the input port 49a connected to the vacuum source 24 to the output port 49c, such that a relatively low pressure level is applied to the working fluid 74' contained in the working chamber 56b, thereby switching the diaphragm 66f to its suction state. Figure 14A Alternatively, the input port 49b, connected to the atmosphere, can be fluidly coupled to the output port 49c, such that a relatively high pressure level is applied to the working fluid 74' contained in the working chamber 56b, thereby switching the diaphragm to its pulsating state. Figures 14B-14C ).

[0181] Controller 45 can be configured to operate three-way valve 47, causing a series of alternating high-pressure (atmospheric) pulse inputs 81a and low-pressure (vacuum) pulse inputs 81b (e.g., Figure 18A (As shown) The working fluid 74' is applied to the working chamber 56b containing the working fluid. Figure 18AAs shown, the peak value of each high-pressure pulse input 81a is higher than the sealing pressure threshold, thereby switching the diaphragm 66f from its suction state to its pulsed state. Conversely, the trough value of each low-pressure pulse input 81b is lower than the unsealing pressure threshold, thereby switching the diaphragm 66f from its pulsed state to its suction state. Therefore, in response to applying a pressure waveform input to the working fluid 74' contained in the working chamber 56b, the diaphragm 66f will repeatedly cycle from its suction state to its pulsed state and then back from its pulsed state to its suction state.

[0182] Alternatively, controller 45 can be configured to operate three-way valve 47, such that... Figure 18B As shown, a series of high-pressure (atmospheric) pulse inputs 81a, on the baseline low-pressure input 81c, are applied to the working fluid 74' contained in the working chamber 56b. Figure 18B As shown, the peak value of each high-pressure pulse input 81a is higher than the sealing pressure threshold, thereby pulling the diaphragm 66f from its suction state ( Figure 14A ) transition to its pulse state ( Figures 14B-14C Conversely, the base of each low-pressure pulse input 81b is below the unsealing pressure threshold, thereby transitioning the diaphragm 66f from its pulsed state to its suction state. Therefore, in response to the application of a pressure waveform input to the working fluid 74' contained in the working chamber 56b, the diaphragm 66f will repeatedly cycle from its suction state to its pulsed state and back to its suction state.

[0183] In a preferred embodiment, the pressure control device 25' may further include the previously described sensor 48. In this case, the controller 45 may optionally operate the three-way valve 47 in response to a signal from the sensor 48 indicating that a blockage event has occurred (i.e., the aspiration catheter 22 is blocked by a thrombus) or a clearance event has occurred (i.e., the thrombus has been taken up by the aspiration catheter 22). For example, if the signal output by the sensor 48 indicates that a blockage event has occurred, the controller 45 may operate the three-way valve 47 to... Figure 18A The series of alternating high-voltage pulse inputs 81a and low-voltage pulse inputs 81b shown are... Figure 18B A series of high-pressure pulse inputs 81a on the baseline low-pressure input 81c, as shown, are applied to the working fluid 74' contained in the working chamber 56b, causing the diaphragm 66f to cycle between its aspiration state and its pulsed state in an attempt to agitate and clear thrombi from the aspiration catheter 22. Conversely, if a signal output from sensor 48 indicates that a clearance event has occurred, controller 45 can operate three-way valve 47 to continuously apply the baseline low-pressure input 81c to the working fluid 74' contained in the working chamber 56b, thus maintaining the diaphragm 66f in its aspiration state for normal aspiration. In this way, the pressure control device 25' can be fully automatic.

[0184] In an alternative embodiment, the pressure control device 25' can be semi-automatic, meaning that instead of using sensor 48, controller 45 receives input from the user (e.g., toggling a switch or pressing a button). For example, in response to user input indicating a blockage event, three-way valve 47 can be operated to... Figure 18A The series of alternating high-voltage pulse inputs 81a and low-voltage pulse inputs 81b shown are... Figure 18B A series of high-pressure pulse inputs 81a on the baseline low-pressure input 81c shown are applied to the working fluid 74' contained in the working chamber 56b, causing the diaphragm 66f to cycle between its aspiration state and its pulsed state in an attempt to agitate and clear thrombi from the aspiration catheter 22. Conversely, in response to a user input informing of a clearance event, the three-way valve 47 can continuously apply low pressure (vacuum) to the working fluid 74' contained in the working chamber 56b, keeping the diaphragm 66f in its aspiration state for normal aspiration. Alternatively, after a predetermined number of high-pressure pulse inputs have been applied to the working fluid 74' contained in the working chamber 56b, the three-way valve 47 can be operated to apply low pressure (vacuum) to the working fluid 74' contained in the working chamber 56b.

[0185] refer to Figure 17B The pressure control device 25'' may include a user input device 51 (e.g., a toggle switch or button) instead of the controller 45, which manually operates a three-way valve 47 (e.g., via a solenoid valve) (not shown). That is, for each input from the user input device 51, a trigger signal is sent to the three-way valve 47, which applies a single high-pressure input pulse to the working fluid 74' contained in the working chamber 56b, causing the diaphragm 66f to transition from its aspiration state to its pulsating state in an attempt to agitate and clear thrombi from the aspiration catheter 22. The three-way valve 47 then applies a low-pressure input (e.g., via a solenoid valve) to the working fluid 74' contained in the working chamber 56b. Figure 18A The high-pressure pulse input 81a is removed from the working fluid 74' contained in the working chamber 56b shown, or by applying... Figure 18B The low-pressure pulse input 81b shown causes the diaphragm 66f to switch from its pulsed state back to its suction state to achieve normal suction.

[0186] exist Figure 16C In another embodiment shown, the pressure control device 25' includes a pressure generator 53 connected to a pressure port 64 of the pressure manifold 46. The pressure generator 53 is capable of applying any pressure input to the working fluid 74' contained in the working chamber 56b. For example, Figure 17C The exemplary pressure waveform input shown includes a primary baseline low pressure (vacuum) 81c and a secondary baseline medium pressure 81d modulated by a high-pressure pulse input 81a. Figure 17CAs shown, the peak value of each high-pressure pulse input 81a is higher than the sealing pressure threshold, thereby pulling the diaphragm 66f from its suction state ( Figure 14A ) transition to its pulse state ( Figures 14B-14C The base of each low-pressure pulse input 81b is larger than the unsealing pressure threshold, preventing the diaphragm 66f from transitioning back to its suction state from its pulsed state. Therefore, in response to applying a pressure waveform input to the working fluid 74' contained in the working chamber 56b, the diaphragm 66f will transition from its suction state to its pulsed state, in which a series of high-pressure pulse inputs 81a will exist for a period of time, and the diaphragm will only transition back to its suction state from its pulsed state when the primary baseline low pressure (vacuum) 81c falls below the unsealing pressure threshold.

[0187] Preferably, the pressure control device 25''' further includes the previously described sensor 48. In this case, the pressure generator 53 can operate in response to a signal from the sensor 48 indicating that a blockage event has occurred (i.e., the aspiration catheter 22 is blocked by a thrombus) or a clearance event has occurred (i.e., the thrombus has been aspirated by the aspiration catheter 22). For example, if the signal output by the sensor 48 indicates a blockage event, the pressure generator 53 can apply a baseline moderate pressure 81d modulated with a high-pressure pulse input 81a to the working fluid 74' contained in the working chamber 56b, causing the diaphragm 66f to transition from its aspiration state to its pulsed state in an attempt to agitate and clear the thrombus from the aspiration catheter 22. Conversely, if the signal output by the sensor 48 indicates a clearance event, the pressure generator 53 can apply a low pressure (vacuum) 81c to the working fluid 74' contained in the working chamber 56b, causing the diaphragm 66f to transition from its pulsed state to its aspiration state and remain in its aspiration state for normal aspiration. Thus, the pressure control device 25''' can be fully automatic.

[0188] In an alternative embodiment, the pressure control device 25''' can be semi-automatic, i.e., instead of using sensor 48, pressure generator 53 receives input from the user (e.g., toggling a switch or pressing a button). For example, in response to user input informing of a blockage event, pressure generator 53 can be triggered to apply a baseline moderate pressure 81d modulated with high-pressure pulse input 81a to the working fluid 74' contained in working chamber 56b, causing diaphragm 66f to transition from its aspiration state to its pulsating state in an attempt to agitate and clear the thrombus in aspiration catheter 22. Conversely, in response to user input informing of a clearance event (or, after a predetermined number of pulse inputs 81a have been applied to the working fluid 74' contained in working chamber 56b), pressure generator 53 can be triggered to apply a low pressure (vacuum) to the working fluid 74' contained in working chamber 56b, causing diaphragm 66f to remain in its aspiration state for normal aspiration.

[0189] It should be noted that the diaphragm 66f will be affected by the high-pressure pulse input applied to the working fluid 74' (e.g., Figures 18A-18C Any high-pressure pulse input 81a shown corresponds to a pressure pulse output applied to the suction fluid 74 contained in the pressure chamber 56a. In one embodiment, the shape of the high-pressure pulse output corresponds to the shape of the high-pressure pulse input. For example, the pressure pulse output may be a rectangular shape corresponding to the rectangular shape of the high-pressure pulse input (e.g., Figures 18A-18C (As shown). In an optional embodiment, the high-pressure pulse input can have a shape other than a rectangle, in which case the pressure pulse output can be a non-rectangular shape corresponding to the non-rectangular shape of the high-pressure pulse input.

[0190] In another alternative embodiment, the diaphragm 66f can be configured to modulate a high-pressure pulse input applied to the working fluid 74' contained in the working chamber 56b, such that a high-pressure pulse output applied to the suction fluid 74 contained in the pressure chamber 56a corresponds to the modulated pressure pulse input. For example, the physical properties (e.g., thickness, stiffness, shape, material, reinforcement, etc.) of the pulse region 71 of the diaphragm 66f can be selected in a manner that modulates (or amplifies) the high-pressure pulse input. In this way, as... Figure 19 As shown, if the high-pressure pulse input 81a applied to the working fluid 74' contained in the working chamber 56b is essentially rectangular, the diaphragm 66f can adjust the high-pressure pulse input 81a such that the pressure pulse output 81a' applied to the suction fluid 74 contained in the pressure chamber 56a can be non-rectangular. For example, the deflection of the diaphragm may not occur uniformly across its surface or within different pressure differentials. For example, as from Figure 15B Understandably, different regions of diaphragm 66b can deform non-uniformly. Similarly, for a given region of diaphragm 66b, the magnitude of deformation can vary non-linearly with respect to the pressure differential. Therefore, a very uniform or regular input pressure waveform (in this case, a series of pressure pulses input) can lead to a highly complex output pressure waveform (in this case, a series of pressure pulses output).

[0191] Although specific embodiments have been shown and described herein, those skilled in the art will understand that they are not intended to limit the disclosed invention, and it will be apparent to them that various changes, arrangements, and modifications (e.g., the dimensions of various components, combinations of components) can be made without departing from the scope of the disclosed invention as defined solely by the appended claims and their equivalents. Therefore, the specification and drawings should be considered illustrative rather than restrictive. The various embodiments shown and described herein are intended to cover alternatives, modifications, and equivalents of the disclosed invention that may be included within the scope of the appended claims.

[0192] Numbered Embodiments of the Invention 1. A suction modulation device for use with a suction conduit and a vacuum source, comprising: A pressure manifold includes a manifold body, a vacuum outlet, and a vacuum inlet, the manifold body having a pressure chamber configured to contain a variable volume of pressure-modulating fluid, the vacuum outlet being configured to fluidly couple a vacuum source to the pressure chamber, and the vacuum inlet being configured to fluidly couple a suction conduit to the pressure chamber. A sensor configured to measure parameters indicating fluid pressure at the distal end of the aspiration catheter; A controller configured to dynamically modify a waveform signal corresponding to a modulated therapeutic pressure waveform in response to measured parameters; and A fluid pressure oscillator is configured to oscillate a variable volume of pressure-modulated fluid within a pressure chamber according to a dynamically modified waveform signal, thereby modulating the vacuum pressure within the pressure chamber such that the fluid pressure at the distal end of the suction conduit tracks the desired modulated pressure waveform.

[0193] 2. The suction modulation device according to Embodiment 1, wherein the pressure manifold further has a vent inlet configured to fluidly couple a pressurized fluid source to the pressure chamber, and the suction modulation device further includes a fluid refill control element configured to selectively fluidly couple the pressurized fluid source to the pressure chamber.

[0194] 3. The suction modulation device according to Embodiment 2, wherein when the fluid pressure in the pressure chamber drops below a threshold fluid pressure, the fluid refill control element is configured to deliver pressure modulation fluid from the pressurized fluid source into the pressure chamber.

[0195] 4. The suction modulation device according to any one of embodiments 1-3, wherein the sensor is a force feedback sensor configured to measure the force output of the fluid pressure oscillator.

[0196] 5. The suction modulation device according to any one of embodiments 1-3, wherein the sensor is a pressure sensor.

[0197] 6. The suction modulation device according to embodiment 5, wherein the pressure sensor is configured to measure the fluid pressure in the pressure chamber.

[0198] 7. The suction modulation device according to any one of embodiments 1 to 6, wherein the fluid pressure oscillator comprises: A pressure transducer element configured to engage with a pressure-modulated fluid within the pressure chamber; An actuator, configured to be operatively coupled to the pressure transducer; and A driver configured to control the actuator to physically move the pressure transducer in a manner that oscillates the variable volume of the pressure-modulated fluid within the pressure chamber, thereby modulating the vacuum pressure within the pressure chamber such that the fluid pressure at the distal end of the suction conduit tracks a desired modulated pressure waveform.

[0199] 8. The suction modulation device according to embodiment 7, wherein the pressure transducer includes a movable manifold boundary, and wherein the actuator is configured to control the actuator to reciprocately move the movable manifold boundary.

[0200] 9. The suction modulation device according to embodiment 8, wherein the movable manifold boundary is a diaphragm fixed within the manifold cavity, thereby dividing the manifold cavity into the pressure chamber and a working chamber fluidly isolated from the vacuum inlet and the vacuum outlet, wherein the actuator is configured to control the actuator to physically move the diaphragm by flexing the diaphragm.

[0201] 10. The suction modulation device according to Example 9, wherein the actuator is directly mechanically coupled to the diaphragm.

[0202] 11. The suction modulation device according to Embodiment 10, wherein the actuator includes a rod directly mechanically coupled to the diaphragm.

[0203] 12. The suction modulation device according to Embodiment 10 or Embodiment 11, wherein the actuator is removably coupled to the diaphragm.

[0204] 13. The suction modulation device according to embodiment 9, wherein the actuator is fluidly coupled to the diaphragm.

[0205] 14. The suction modulation device according to embodiment 9, wherein the pressure transducer is a secondary pressure transducer, and wherein the fluid pressure oscillator further includes a primary pressure transducer fluidly coupled to the secondary pressure transducer.

[0206] 15. The suction modulation device according to embodiment 14, wherein the primary pressure transducer is a piston, and wherein the actuator includes a piston shaft mechanically coupled to the piston.

[0207] 16. The suction modulation device according to Embodiment 15, wherein the manifold cavity includes a cylinder with a reduced diameter and a cylinder with an increased diameter, the piston is reciprocally disposed in the cylinder with a reduced diameter, and the diaphragm is fixed in the cylinder with an increased diameter, such that the cylinder with an increased diameter is divided into the pressure chamber and the working chamber, wherein the working chamber contains a primary pressure modulation fluid, and the pressure modulation fluid contained in the pressure chamber is a secondary pressure modulation fluid.

[0208] 17. The suction modulation device according to Embodiment 14, wherein the secondary pressure transducer is a diaphragm and the primary pressure transducer is another diaphragm.

[0209] 18. The suction modulation device according to Embodiment 14, wherein the primary pressure transducer element is contained within the manifold cavity.

[0210] 19. The suction modulation device according to Embodiment 14, wherein the primary pressure transducer element is outside the manifold cavity.

[0211] 20. The suction modulation device according to embodiment 19 further includes a flexible fluid conduit for fluidly coupling the primary pressure transducer to the secondary pressure transducer.

[0212] 21. The suction modulation device according to Embodiment 7, wherein the actuator is a linear actuator, and the driver is configured to control the actuator to physically move the pressure transducer element in a manner that repeatedly changes the variable volume of the pressure modulation fluid within the pressure chamber.

[0213] 22. The suction modulation apparatus according to embodiment 21, wherein the actuator is a voice coil actuator.

[0214] 23. The suction modulation device according to any one of embodiments 7-22, wherein the driver is an electric driver.

[0215] 24. The suction modulation device according to Embodiment 1 further includes another pressure oscillator, wherein the fluid pressure oscillator and the other pressure oscillator are configured to simultaneously and independently oscillate a variable volume of pressure-modulated fluid in the pressure chamber according to a dynamically modified waveform signal, thereby modulating the vacuum pressure in the pressure chamber such that the fluid pressure at the distal end of the suction conduit tracks the desired modulated pressure waveform.

[0216] 25. The suction modulation device according to embodiment 24, wherein the desired modulation pressure waveform is a desired modulation composite pressure waveform having at least two different fundamental frequencies.

[0217] 26. The suction modulation device according to any one of embodiments 1-25, wherein the controller is configured to select one of a plurality of different modulated therapeutic pressure waveforms, and wherein the waveform signal dynamically modified in response to the measured parameters corresponds to the selected modulated therapeutic waveform.

[0218] 27. The suction modulation device according to embodiment 26 further includes a user interface configured to receive user input for selecting the one modulation treatment waveform.

[0219] 28. The suction modulation device according to any one of Examples 1-25, The controller is further configured to generate multiple waveform signals corresponding to multiple different modulated diagnostic pressure waveforms, wherein the fluid pressure oscillator is configured to sequentially oscillate a variable volume pressure modulated fluid in the pressure chamber according to the multiple waveform signals, thereby modulating the vacuum pressure in the pressure chamber. The suction modulation device further includes a processor configured to analyze the measured parameters in response to modulation of the vacuum pressure within the pressure chamber, and to generate or select a modulated therapeutic pressure waveform based on the analysis of the measured parameters.

[0220] 29. The suction modulation device according to embodiment 28, wherein the plurality of different modulation diagnostic pressure waveforms have different frequencies.

[0221] 30. The suction modulation device according to Example 28 or Example 29, The controller is configured to generate the plurality of waveform signals in response to a thrombus occluding the aspiration catheter; and The processor is configured to determine one or more characteristics of the thrombus based on analysis of the measured parameters, and to generate or select the modulated therapeutic pressure waveform based on the determined characteristics of the thrombus.

[0222] 31. The suction modulation device according to Embodiment 28 or Embodiment 29, When the suction conduit is connected to the suction modulation device, the controller is configured to generate the plurality of waveform signals; and The processor is configured to determine the type of the aspiration catheter based on analysis of the measured parameters, and to generate or select the modulated therapeutic pressure waveform based on the determined type of aspiration catheter.

[0223] 32. The suction modulation device according to any one of embodiments 1-31 further includes: The main unit includes a first housing that accommodates the controller; and The slave unit includes a second housing that houses at least a portion of the fluid pressure oscillator and the pressure manifold.

[0224] 33. The suction modulation device according to embodiment 31 further includes a flexible fluid conduit for fluidly coupling the main unit and the slave unit to each other.

[0225] 34. The suction modulation device according to embodiment 32, wherein the master unit is configured to be inserted into the second housing of the slave unit.

[0226] 35. The suction modulation device according to embodiment 34, wherein the master unit is configured to be electrically coupled to the slave unit when inserted into the second housing of the slave unit.

[0227] 36. The suction modulation apparatus according to any one of embodiments 1 to 35, wherein the fluid pressure modulated by the fluid pressure oscillator is the baseline vacuum pressure applied to the pressure chamber by the vacuum source.

[0228] 37. A suction system, comprising: The suction modulation device according to any one of Examples 1-36; The vacuum source; and The suction catheter.

[0229] 38. A suction modulation device for use with a suction conduit and a vacuum source, comprising: A pressure manifold, comprising a manifold body, a vacuum outlet, and a vacuum inlet, the manifold body having a pressure chamber configured to contain a variable volume of pressure-modulating fluid, the vacuum outlet configured to fluidly couple a vacuum source to the pressure chamber, and the vacuum inlet configured to fluidly couple a suction conduit to the pressure chamber; and A fluid pressure oscillator includes a diaphragm fixed within the manifold cavity to divide the manifold cavity into a pressure chamber and a working chamber fluidly isolated from the vacuum inlet and the vacuum outlet. The fluid pressure oscillator is configured to oscillate a variable volume of pressure-modulating fluid within the pressure chamber via the diaphragm, thereby modulating the vacuum pressure within the pressure chamber.

[0230] 39. The suction modulation device according to embodiment 38, the suction modulation device further includes a controller configured to output a waveform signal corresponding to a modulated therapeutic pressure waveform, wherein the fluid pressure oscillator is configured to oscillate a variable volume pressure-modulated fluid in the pressure chamber via the diaphragm according to the waveform signal, thereby modulating the vacuum pressure in the pressure chamber.

[0231] 40. The suction modulation device according to embodiment 39 further includes a sensor configured to measure a parameter indicating fluid pressure at the distal end of the suction conduit, wherein the controller is configured to dynamically modify the waveform signal in response to the measured parameter, and wherein the fluid pressure oscillator is configured to oscillate a variable volume of pressure-modulated fluid in the pressure chamber via the diaphragm according to the dynamically modified waveform signal, such that the fluid pressure at the distal end of the suction conduit tracks a desired modulated pressure waveform.

[0232] 41. The suction modulation device according to any one of embodiments 38 to 40, wherein the fluid pressure oscillator further comprises: An actuator, the actuator being configured to be operatively coupled to the diaphragm; and A driver configured to control the actuator to cause the diaphragm to flex in a manner that oscillates a variable volume of pressure-modulating fluid within the pressure chamber, thereby modulating the vacuum pressure within the pressure chamber.

[0233] 42. The suction modulation device according to embodiment 41, wherein the actuator is directly mechanically coupled to the diaphragm.

[0234] 43. The suction modulation device according to embodiment 42, wherein the actuator includes a rod directly mechanically coupled to the diaphragm.

[0235] 44. The suction modulation device according to embodiment 42 or embodiment 43, wherein the actuator is removably coupled to the diaphragm.

[0236] 45. The suction modulation device according to embodiment 41, wherein the actuator is fluidly coupled to the diaphragm.

[0237] 46. ​​The suction modulation device according to embodiment 41, wherein the diaphragm is a secondary pressure transducer element, and wherein the fluid pressure oscillator further comprises a primary pressure transducer element fluidly coupled to the secondary pressure transducer element.

[0238] 47. The suction modulation device according to embodiment 46, wherein the fluid pressure oscillator further includes a piston, and wherein the actuator includes a piston shaft mechanically coupled to the piston, and wherein the actuator is fluidly coupled to the diaphragm via the piston.

[0239] 48. The suction modulation device according to embodiment 47, wherein the manifold cavity includes a cylinder with a reduced diameter and a cylinder with an increased diameter, the piston is reciprocally disposed in the cylinder with a reduced diameter, and the secondary pressure transducer is fixed in the cylinder with an increased diameter, such that the cylinder with an increased diameter is divided into the pressure chamber and the working chamber, wherein the working chamber contains the primary pressure modulation fluid, and the pressure modulation fluid contained in the pressure chamber is the secondary pressure modulation fluid.

[0240] 49. The suction modulation device according to embodiment 46, wherein the primary pressure transducer element is another diaphragm.

[0241] 50. The suction modulation device according to embodiment 46, wherein the primary pressure transducer element is housed within the manifold cavity.

[0242] 51. The suction modulation device according to embodiment 46, wherein the primary pressure transducer element is outside the manifold cavity.

[0243] 52. The suction modulation device according to embodiment 51 further includes a flexible fluid conduit for fluidly coupling the primary pressure transducer element to the secondary pressure transducer element.

[0244] 53. The suction modulation device according to embodiment 41, wherein the actuator is a linear actuator and the driver is configured to control the actuator to cause the diaphragm to flex in a manner that repeatedly changes the variable volume of the pressure modulation fluid within the pressure chamber.

[0245] 54. The suction modulation apparatus according to embodiment 53, wherein the actuator is a voice coil actuator.

[0246] 55. The suction modulation device according to any one of embodiments 41-54, wherein the driver is an electric driver.

[0247] 56. The suction modulation device according to embodiment 38 further includes another pressure oscillator, the other pressure oscillator comprising another diaphragm fixed opposite to the diaphragm within the manifold cavity, such that the manifold cavity is divided into a pressure chamber between opposing diaphragms and a working chamber outside the opposing diaphragms, the working chamber being fluidly isolated from the vacuum inlet and the vacuum outlet, wherein the fluid pressure oscillator and the other pressure oscillator are configured to simultaneously and independently oscillate a variable volume of pressure-modulating fluid within the pressure chamber via the respective diaphragm, thereby modulating the vacuum pressure within the pressure chamber.

[0248] 57. The suction modulation apparatus according to any one of embodiments 38 to 56, wherein the fluid pressure modulated by the fluid pressure oscillator is the baseline vacuum pressure applied to the pressure chamber by the vacuum source.

[0249] 58. A dynamic suction system, comprising: The suction modulation device according to any one of embodiments 38-57; The vacuum source; and The suction catheter.

[0250] 59. A suction modulation device for use with a suction conduit and a vacuum source, comprising: A pressure manifold, comprising a manifold body, a vacuum outlet, and a vacuum inlet, the manifold body having a pressure chamber configured to contain a variable volume of pressure-modulating fluid, the vacuum outlet configured to fluidly couple a vacuum source to the pressure chamber, and the vacuum inlet configured to fluidly couple a suction conduit to the pressure chamber; and Multiple fluid pressure oscillators are configured to simultaneously oscillate a variable volume of pressure-modulating fluid within the pressure chamber, thereby modulating the vacuum pressure within the pressure chamber.

[0251] 60. The suction modulation apparatus according to embodiment 59, wherein the plurality of fluid pressure oscillators are configured to independently oscillate a variable volume of pressure modulation fluid within the pressure chamber, thereby modulating the vacuum pressure within the pressure chamber.

[0252] 61. The suction modulation device according to embodiment 59 further includes a controller configured to output a waveform signal corresponding to a modulated therapeutic pressure waveform, wherein the plurality of fluid pressure oscillators are configured to simultaneously oscillate a variable volume of pressure modulation fluid in the pressure chamber according to the waveform signal, thereby modulating the vacuum pressure in the pressure chamber.

[0253] 62. The suction modulation device according to embodiment 61 further includes a sensor configured to measure a parameter indicating fluid pressure at the distal end of the suction conduit, wherein the controller is configured to dynamically modify the waveform signal in response to the measured parameter, and wherein the plurality of fluid pressure oscillators are configured to simultaneously oscillate a variable volume of pressure-modulated fluid within the pressure chamber according to the dynamically modified waveform signal, such that the fluid pressure at the distal end of the suction conduit tracks a desired modulated pressure waveform.

[0254] 63. The suction modulation device according to embodiment 61, wherein the waveform signal corresponds to a composite pressure waveform having at least two different fundamental frequencies.

[0255] 64. The suction modulation apparatus according to any one of embodiments 59 to 63, wherein each of the plurality of fluid pressure oscillators further comprises: A pressure transducer element configured to engage with a pressure-modulated fluid within the pressure chamber; An actuator, configured to be operatively coupled to the pressure transducer; and A driver configured to control the actuator to physically move the pressure transducer in a manner that oscillates a variable volume of pressure-modulated fluid within the pressure chamber, thereby modulating the vacuum pressure within the pressure chamber.

[0256] 65. The suction modulation device according to embodiment 64, wherein the pressure transducer element of each respective fluid pressure oscillator includes a diaphragm fixed within the manifold cavity.

[0257] 66. The suction modulation apparatus according to embodiment 65, wherein the diaphragms of two of the plurality of fluid pressure oscillators are opposite each other, such that the manifold cavity is divided into a pressure chamber between the opposing diaphragms and a working chamber outside the opposing diaphragms, the working chamber being fluidly isolated from the vacuum inlet and the vacuum outlet, wherein the two fluid pressure oscillators are configured to simultaneously oscillate a variable volume of pressure modulation fluid within the pressure chamber via the respective diaphragms, thereby modulating the vacuum pressure within the pressure chamber.

[0258] 67. The suction modulation device according to embodiment 65, wherein the actuator of each corresponding fluid pressure oscillator is directly coupled to the diaphragm of each corresponding fluid pressure oscillator.

[0259] 68. The suction modulation device according to embodiment 67, wherein the actuator of each respective fluid pressure oscillator includes a rod directly mechanically coupled to the diaphragm of each respective fluid pressure oscillator.

[0260] 69. The suction modulation apparatus according to embodiment 67 or embodiment 68, wherein the actuator of each respective fluid pressure oscillator is removably coupled to the diaphragm of each respective fluid pressure oscillator.

[0261] 70. The suction modulation apparatus according to embodiment 65, wherein the actuator of each respective fluid pressure oscillator is fluidly coupled to the diaphragm of each respective fluid pressure oscillator.

[0262] 71. The suction modulation apparatus according to embodiment 65, wherein the actuator of each respective fluid pressure oscillator is a linear actuator, and the driver of each respective fluid pressure oscillator is configured to control the actuator of each respective fluid pressure oscillator to cause the diaphragm of each respective fluid pressure oscillator to flex, thereby changing the variable volume of the pressure modulation fluid in the pressure chamber in a reciprocating manner.

[0263] 72. The suction modulation apparatus according to embodiment 71, wherein the actuator of each corresponding fluid pressure oscillator is a voice coil actuator.

[0264] 73. The suction modulation device according to any one of embodiments 64 to 72, wherein the driver of each corresponding fluid pressure oscillator is an electric driver.

[0265] 74. The suction modulation apparatus according to any one of embodiments 59 to 73, wherein the fluid pressure modulated by the fluid pressure oscillator is the baseline vacuum pressure applied to the pressure chamber by the vacuum source.

[0266] 75. A dynamic suction system, comprising: The suction modulation device according to any one of embodiments 59-74; The vacuum source; and The suction catheter.

[0267] 76. A suction modulation device for use with a suction conduit, a vacuum source, and a pressurized fluid source, comprising: A pressure manifold includes a manifold body, a vacuum outlet, a vacuum inlet, and a vent inlet. The manifold body has a pressure chamber configured to contain a variable volume of pressure-modulating fluid. The vacuum outlet is configured to fluidly couple a vacuum source to the pressure chamber. The vacuum inlet is configured to fluidly couple a suction conduit to the pressure chamber. The vent inlet is configured to fluidly couple a pressurized fluid source to the pressure chamber. A fluid pressure oscillator configured to oscillate a variable volume of pressure-modulating fluid within the pressure chamber, thereby modulating the vacuum pressure within the pressure chamber; and A fluid refill control element configured to selectively fluid couple the pressurized fluid source to the pressure chamber.

[0268] 77. The suction modulation apparatus according to embodiment 76, wherein when the fluid pressure in the pressure chamber drops below a threshold fluid pressure, the fluid refill control element is configured to deliver pressure modulation fluid from the pressurized fluid source into the pressure chamber.

[0269] 78. The suction modulation device according to embodiment 76 or embodiment 77, wherein the fluid refill control element is a check valve.

[0270] 79. The suction modulation device according to any one of embodiments 76-78, wherein the pressurized fluid source is at atmospheric pressure.

[0271] 80. The suction modulation device according to any one of embodiments 76-79 further includes a controller configured to output a waveform signal corresponding to a modulated therapeutic pressure waveform, wherein the fluid pressure oscillator is configured to oscillate a variable volume pressure-modulated fluid in the pressure chamber according to the waveform signal, thereby modulating the vacuum pressure in the pressure chamber.

[0272] 81. The suction modulation device according to embodiment 80 further includes a sensor configured to measure a parameter indicating fluid pressure at the distal end of the suction conduit, wherein the controller is configured to dynamically modify the waveform signal in response to the measured parameter, and wherein the fluid pressure oscillator is configured to oscillate a variable volume of pressure-modulated fluid in the pressure chamber according to the dynamically modified waveform signal, such that the fluid pressure at the distal end of the suction conduit tracks a desired modulated pressure waveform.

[0273] 82. The suction modulation device according to any one of embodiments 76 to 81, wherein the fluid pressure oscillator comprises: A pressure transducer element configured to engage with a pressure-modulated fluid within the pressure chamber; An actuator, configured to be operatively coupled to the pressure transducer; and A driver configured to control the actuator to physically move the pressure transducer in a manner that oscillates a variable volume of pressure-modulated fluid within the pressure chamber, thereby modulating the vacuum pressure within the pressure chamber such that the fluid pressure at the distal end of the suction conduit tracks a desired modulated pressure waveform.

[0274] 83. The suction modulation apparatus according to embodiment 82, wherein the pressure transducer includes a movable manifold boundary, and wherein the actuator is configured to control the actuator to reciprocately move the movable manifold boundary.

[0275] 84. The suction modulation apparatus according to embodiment 83, wherein the movable manifold boundary is a diaphragm fixed within the manifold cavity, thereby dividing the manifold cavity into the pressure chamber and a working chamber fluidly isolated from the vacuum inlet and the vacuum outlet, wherein the actuator is configured to control the actuator to physically move the diaphragm by flexing the diaphragm.

[0276] 85. The suction modulation device according to any one of embodiments 82-84, wherein the actuator is a linear actuator and the driver is configured to control the actuator to cause the diaphragm to flex in a manner that repeatedly changes the variable volume of the pressure modulation fluid within the pressure chamber.

[0277] 86. The suction modulation apparatus according to embodiment 85, wherein the actuator is a voice coil actuator.

[0278] 87. The suction modulation device according to any one of embodiments 82-86, wherein the driver is an electric driver.

[0279] 88. The suction modulation apparatus according to any one of embodiments 76 to 87, wherein the fluid pressure modulated by the fluid pressure oscillator is the baseline vacuum pressure applied to the pressure chamber by the vacuum source.

[0280] 89. A dynamic suction system, comprising: The suction modulation device according to any one of embodiments 76-88; The vacuum source; and The suction catheter.

[0281] 90. A suction modulation device for use with a suction conduit and a vacuum source, comprising: A controller configured to output a waveform signal corresponding to a modulated therapeutic pressure waveform; A pressure manifold includes a manifold body, a vacuum outlet, and a vacuum inlet, the manifold body having a pressure chamber configured to contain a variable volume of pressure-modulating fluid, the vacuum outlet being configured to fluidly couple a vacuum source to the pressure chamber, and the vacuum inlet being configured to fluidly couple a suction conduit to the pressure chamber. A fluid pressure oscillator configured to oscillate a variable volume of pressure-modulating fluid within a pressure chamber according to the waveform signal, thereby modulating the vacuum pressure within the pressure chamber; The main unit includes a housing that carries the controller; and The slave unit includes a housing carrying at least a portion of the pressure manifold and at least a portion of the fluid pressure oscillator, wherein the master unit is configured to be operatively coupled to and operatively decoupled from the slave unit.

[0282] 91. The suction modulation device according to embodiment 90 further includes a sensor carried by the slave unit and configured to measure a parameter indicating fluid pressure at the distal end of the suction catheter, wherein the controller is configured to dynamically modify the waveform signal in response to the measured parameter, and wherein the fluid pressure oscillator is configured to oscillate a variable volume of pressure-modulated fluid in the pressure chamber according to the dynamically modified waveform signal, such that the fluid pressure at the distal end of the suction catheter tracks a desired modulated pressure waveform.

[0283] 92. The suction modulation device according to embodiment 90 or embodiment 91, wherein the housing of the main unit carries at least another part of the fluid pressure oscillator.

[0284] 93. The suction modulation device according to embodiment 92, wherein the fluid pressure oscillator comprises: A pressure transducer element, which is carried by the slave unit and configured to engage with a pressure-modulated fluid within the pressure chamber; An actuator, configured to be operatively coupled to the pressure transducer; and A driver configured to control the actuator to physically move the pressure transducer in a manner that oscillates a variable volume of pressure-modulated fluid within the pressure chamber, thereby modulating the vacuum pressure within the pressure chamber such that the fluid pressure at the distal end of the suction conduit tracks a desired modulated pressure waveform. The pressure transducer element is carried by the housing of the slave unit; and The driver is carried by the housing of the main unit.

[0285] 94. The suction modulation device according to embodiment 93, wherein the actuator is carried by the housing of the main unit.

[0286] 95. The suction modulation device according to embodiment 94, wherein the respective housings of the main unit and the slave unit are housing portions, the housing portions being directly mechanically fixed to each other to form a single housing.

[0287] 96. The suction modulation apparatus according to any one of embodiments 92-95, wherein the pressure transducer includes a movable manifold boundary, and wherein the actuator is configured to control the actuator to reciprocately move the movable manifold boundary.

[0288] 97. The suction modulation apparatus according to embodiment 96, wherein the movable manifold boundary is a diaphragm fixed within the manifold cavity, thereby dividing the manifold cavity into the pressure chamber and a working chamber fluidly isolated from the vacuum inlet and the vacuum outlet, wherein the actuator is configured to control the actuator to physically move the diaphragm by flexing the diaphragm.

[0289] 98. The suction modulation apparatus according to embodiment 97, wherein the actuator is directly mechanically coupled to the diaphragm.

[0290] 99. The suction modulation device according to embodiment 98, wherein the actuator includes a rod directly mechanically coupled to the diaphragm.

[0291] 100. The suction modulation apparatus according to Example 98 or Example 99, wherein the actuator is removably coupled to the diaphragm.

[0292] 101. The suction modulation device according to embodiment 99, wherein the pressure transducer is a secondary pressure transducer contained in the manifold cavity, and wherein the fluid pressure oscillator further includes a primary pressure transducer, the primary pressure transducer being carried by the housing portion of the main unit and fluidly coupled to the secondary pressure transducer.

[0293] 102. The suction modulation device according to embodiment 101, wherein the primary pressure transducer is a piston, and wherein the actuator includes a piston shaft mechanically coupled to the piston.

[0294] 103. The suction modulation device according to embodiment 102, wherein the manifold cavity includes a cylinder with a reduced diameter and a cylinder with an increased diameter, the piston is reciprocally disposed in the cylinder with a reduced diameter, and the diaphragm is fixed in the cylinder with an increased diameter, such that the cylinder with an increased diameter is divided into the pressure chamber and the working chamber, wherein the working chamber contains a primary pressure modulation fluid, and the pressure modulation fluid contained in the pressure chamber is a secondary pressure modulation fluid.

[0295] 104. The suction modulation device according to any one of embodiments 93-103, wherein the pressure transducer is a secondary pressure transducer contained in the manifold cavity, and wherein the fluid pressure oscillator further includes a primary pressure transducer carried by the housing of the main unit, and the suction modulation device further includes a flexible fluid conduit for fluidly coupling the primary pressure transducer to the secondary pressure transducer.

[0296] 105. The suction modulation device according to embodiment 93, wherein the actuator is a linear actuator and the driver is configured to control the actuator to physically move the pressure transducer element in a manner that reciprocally changes the variable volume of the pressure modulation fluid within the pressure chamber.

[0297] 106. The suction modulation apparatus according to embodiment 105, wherein the actuator is a voice coil actuator.

[0298] 107. The suction modulation device according to any one of embodiments 90-106, wherein the driver is an electric driver.

[0299] 108. The suction modulation apparatus according to embodiments 90-103, wherein the master unit is configured to be inserted into the slave unit.

[0300] 109. The suction modulation apparatus according to any one of embodiments 90 to 108, wherein the fluid pressure modulated by the fluid pressure oscillator is the baseline vacuum pressure applied to the pressure chamber by the vacuum source.

[0301] 110. A dynamic suction system, comprising: The suction modulation device according to any one of embodiments 90-109; The vacuum source; and The suction catheter.

[0302] 111. A suction device for use with a suction conduit and a vacuum source, comprising: A pressure manifold includes a manifold body having a pressure chamber and a working chamber, a vacuum outlet configured to fluidly couple the vacuum source to the pressure chamber, and a vacuum inlet configured to fluidly couple the suction conduit to the pressure chamber; and A diaphragm fixed within the manifold cavity is used to fluidly isolate the pressure chamber from the working chamber. The diaphragm is configured to apply a blockage-clearing pressure to the suction fluid contained in the pressure chamber in response to a force applied from the working chamber to the diaphragm.

[0303] 112. The suction device according to embodiment 111, wherein the vacuum outlet is configured to couple a vacuum source fluid to the pressure chamber during the period when the diaphragm applies blockage-clearing pressure to the suction fluid contained in the pressure chamber.

[0304] 113. The suction device according to embodiment 112, wherein the suction fluid contained in the pressure chamber is a pressure-modulated fluid with a variable volume, the suction device further includes a fluid pressure oscillator configured to apply an oscillating force to a diaphragm, and wherein the diaphragm is configured to oscillate the variable volume pressure-modulated fluid in the pressure chamber in response to the oscillating force applied to the diaphragm, thereby modulating the vacuum pressure in the pressure chamber.

[0305] 114. The suction device according to embodiment 111, wherein the diaphragm is further configured to decouple the vacuum source from the pressure chamber fluid by sealing the vacuum outlet before the diaphragm applies blockage clearance pressure to the suction fluid contained in the pressure chamber.

[0306] 115. The suction device according to embodiment 114, wherein the diaphragm has a sealing region and a deflectable region, the sealing region being configured to contact a vacuum outlet to seal and isolate the vacuum outlet from a pressure chamber, and the deflectable region being configured to deflect within the pressure chamber to apply a blockage-clearing pressure to the suction fluid contained in the pressure chamber.

[0307] 116. The suction device according to embodiment 115, wherein the sealing region is the central circular region of the diaphragm, and the deflectable region is the annular region of the diaphragm.

[0308] 117. A suction device according to any one of embodiments 114-116, wherein the diaphragm is configured to seal and isolate the vacuum outlet from the pressure chamber in response to a pressure in the working chamber exceeding a sealing pressure threshold.

[0309] 118. The suction device according to embodiment 117, wherein the diaphragm is configured to apply blockage removal pressure to the suction fluid contained in the pressure chamber in a dedicated manner.

[0310] 119. The suction device according to Example 117 or Example 118, wherein the diaphragm is further configured to fluidly recouple the vacuum source to the pressure chamber by unsealing the vacuum outlet in response to the pressure in the working chamber being less than the unsealing pressure threshold.

[0311] 120. The aspiration device according to embodiment 119, wherein when the aspiration catheter remains blocked by a thrombus, the unblocking pressure threshold is less than the sealing pressure threshold.

[0312] 121. The aspiration device according to Example 119, wherein when the thrombus in the aspiration catheter is removed, the unsealing pressure threshold is greater than the sealing pressure threshold.

[0313] 122. The suction device according to any one of embodiments 119-121 further includes a spring configured to bias the diaphragm to release the sealed isolation between the vacuum outlet and the pressure chamber.

[0314] 123. The suction device according to any one of Examples 119-121, wherein the diaphragm has a passive restoring force for biasing the diaphragm to release the sealed isolation between the vacuum outlet and the pressure chamber.

[0315] 124. A suction device according to any one of embodiments 119-123, wherein the diaphragm is configured to apply a blockage-clearing pressure to the suction fluid contained in the pressure chamber as a pressure pulse output, and wherein the diaphragm is configured to apply a pressure pulse output to the suction fluid contained in the pressure chamber in response to a pressure pulse input applied to the working fluid contained in the working chamber, wherein the pressure of the peak amplitude of the pressure pulse input is higher than a sealing pressure threshold.

[0316] 125. The suction device according to embodiment 124, wherein the diaphragm is configured to couple a vacuum source to a pressure chamber in response to the removal of a pressure pulse input from the working fluid contained in the working chamber, wherein the pressure of the reference amplitude of the pressure pulse input is below a release pressure threshold.

[0317] 126. The suction device according to embodiment 124, wherein the diaphragm is configured to maintain decoupling of the vacuum source from the pressure chamber in response to the removal of a pressure pulse input from the working fluid contained in the working chamber, wherein the pressure of the reference amplitude of the pressure pulse input is higher than the unsealing pressure threshold.

[0318] 127. The suction device according to any one of embodiments 124-126 further includes a pressure control device configured to apply the pressure pulse input to the working fluid contained in the working chamber.

[0319] 128. The suction device according to embodiment 127, wherein the pressure control device includes a three-way valve configured to apply the pressure pulse input to the working fluid contained in the working chamber by alternately fluidly coupling the working chamber to the atmosphere and another vacuum source.

[0320] 129. The suction device according to embodiment 127, wherein the pressure control device includes a pressure generator configured to apply the pressure pulse input to the working fluid contained in the working chamber by generating the pressure pulse input.

[0321] 130. The suction device according to any one of embodiments 127-129 further includes a sensor configured to measure a parameter indicating fluid pressure at the distal end of the suction conduit, wherein a pressure control device is configured to apply a pressure pulse input to the working fluid contained in the working chamber in response to the measured parameter.

[0322] 131. The suction device according to any one of embodiments 124-130, wherein the diaphragm is configured to modulate the pressure pulse input such that the pressure pulse output corresponds to the modulated pressure pulse input.

[0323] 132. A suction device according to any one of embodiments 124-131, wherein the diaphragm is configured to apply a blockage-clearing pressure to the suction fluid contained in the pressure chamber as a series of pressure pulse outputs, wherein the diaphragm is configured to apply a series of pressure pulse outputs to the suction fluid contained in the pressure chamber in response to a series of pressure pulse inputs applied to the working fluid contained in the working chamber by a pressure control device.

[0324] 133. A dynamic suction system, comprising: The suction device according to any one of embodiments 111-132; The vacuum source; and The suction catheter.

Claims

1. A suction modulation device for use with a suction conduit and a vacuum source, comprising: A pressure manifold includes a manifold body, a vacuum outlet, and a vacuum inlet, the manifold body having a pressure chamber configured to contain a variable volume of pressure-modulating fluid, the vacuum outlet being configured to fluidly couple a vacuum source to the pressure chamber, and the vacuum inlet being configured to fluidly couple a suction conduit to the pressure chamber. A sensor configured to measure parameters indicating fluid pressure at the distal end of the aspiration catheter; A controller is configured to dynamically modify a waveform signal corresponding to a modulated therapeutic pressure waveform in response to measured parameters. and A fluid pressure oscillator is configured to oscillate a variable volume of pressure-modulated fluid within a pressure chamber according to a dynamically modified waveform signal, thereby modulating the vacuum pressure within the pressure chamber such that the fluid pressure at the distal end of the suction conduit tracks a desired modulated pressure waveform.

2. The suction modulation device of claim 1, wherein the pressure manifold further has a vent inlet configured to fluidly couple a pressurized fluid source to the pressure chamber, and the suction modulation device further includes a fluid refill control element configured to selectively fluidly couple the pressurized fluid source to the pressure chamber.

3. The suction modulation device according to claim 2, wherein, When the fluid pressure in the pressure chamber drops below a threshold fluid pressure, the fluid refill control element is configured to deliver pressure modulated fluid from the pressurized fluid source into the pressure chamber.

4. The suction modulation device according to any one of claims 1-3, wherein the sensor is a force feedback sensor configured to measure the force output of the fluid pressure oscillator.

5. The suction modulation device according to any one of claims 1-3, wherein the sensor is a pressure sensor.

6. The suction modulation device according to claim 5, wherein the pressure sensor is configured to measure the fluid pressure in the pressure chamber.

7. The suction modulation device according to any one of claims 1-6, wherein the fluid pressure oscillator comprises: A pressure transducer element configured to engage with the pressure-modulated fluid within the pressure chamber; An actuator configured to be operatively coupled to the pressure transducer element; and A driver configured to control the actuator to physically move the pressure transducer in a manner that oscillates the variable volume of the pressure-modulated fluid within the pressure chamber, thereby modulating the vacuum pressure within the pressure chamber such that the fluid pressure at the distal end of the suction conduit tracks a desired modulated pressure waveform.

8. The suction modulation device of claim 7, wherein the pressure transducer includes a movable manifold boundary, and wherein the actuator is configured to control the actuator to reciprocately move the movable manifold boundary.

9. The suction modulation apparatus of claim 8, wherein the movable manifold boundary is a diaphragm fixed within the manifold cavity, thereby dividing the manifold cavity into the pressure chamber and a working chamber fluidly isolated from the vacuum inlet and the vacuum outlet, wherein the actuator is configured to control the actuator to physically move the diaphragm by flexing the diaphragm.

10. The suction modulation device according to claim 9, wherein the actuator is directly and mechanically coupled to the diaphragm.

11. The suction modulation device of claim 10, wherein the actuator comprises a rod directly mechanically coupled to the diaphragm.

12. The suction modulation device according to claim 10 or claim 11, wherein the actuator is removably coupled to the diaphragm.

13. The suction modulation device of claim 9, wherein the actuator is fluidly coupled to the diaphragm.

14. The suction modulation device of claim 9, wherein the pressure transducer is a secondary pressure transducer, and wherein the fluid pressure oscillator further comprises a primary pressure transducer fluidly coupled to the secondary pressure transducer.

15. The suction modulation device of claim 14, wherein the primary pressure transducer is a piston, and wherein the actuator includes a piston shaft mechanically coupled to the piston.

16. The suction modulation device according to claim 15, wherein the manifold cavity comprises a cylinder with a reduced diameter and a cylinder with an increased diameter, the piston is reciprocally disposed in the cylinder with a reduced diameter, and the diaphragm is fixed in the cylinder with an increased diameter, such that the cylinder with an increased diameter is divided into the pressure chamber and the working chamber, wherein the working chamber contains a primary pressure modulation fluid, and the pressure modulation fluid contained in the pressure chamber is a secondary pressure modulation fluid.

17. The suction modulation device according to claim 14, wherein the secondary pressure transducer is a diaphragm, and the primary pressure transducer is another diaphragm.

18. The suction modulation device according to claim 14, wherein the primary pressure transducer element is contained within the manifold cavity.

19. The suction modulation device according to claim 14, wherein the primary pressure transducer element is outside the manifold cavity.

20. The suction modulation device according to claim 19 further includes a flexible fluid conduit for fluidly coupling the primary pressure transducer to the secondary pressure transducer.

21. The suction modulation device of claim 7, wherein the actuator is a linear actuator, and the driver is configured to control the actuator to physically move the pressure transducer element in a manner that repeatedly changes the variable volume of the pressure modulation fluid in the pressure chamber.

22. The suction modulation apparatus according to claim 21, wherein the actuator is a voice coil actuator.

23. The suction modulation device according to any one of claims 7-22, wherein the driver is an electric driver.

24. The suction modulation apparatus of claim 1, further comprising another pressure oscillator, wherein the fluid pressure oscillator and the other pressure oscillator are configured to simultaneously and independently oscillate the variable volume of the pressure modulation fluid in the pressure chamber according to the dynamically modified waveform signal, thereby modulating the vacuum pressure in the pressure chamber such that the fluid pressure at the distal end of the suction conduit tracks the desired modulated pressure waveform.

25. The suction modulation device of claim 24, wherein the desired modulation pressure waveform is a desired modulation composite pressure waveform having at least two different fundamental frequencies.

26. The suction modulation device according to any one of claims 1-25, wherein the controller is configured to select one of a plurality of different modulated therapeutic pressure waveforms, and wherein the waveform signal dynamically modified in response to the measured parameters corresponds to the selected modulated therapeutic waveform.

27. The suction modulation device of claim 26, further comprising a user interface configured to receive user input for selecting the one modulated therapeutic waveform.

28. The suction modulation device according to any one of claims 1-25, in, The controller is further configured to generate multiple waveform signals corresponding to multiple different modulated diagnostic pressure waveforms, wherein the fluid pressure oscillator is configured to sequentially oscillate the variable volume pressure modulated fluid in the pressure chamber according to the multiple waveform signals, thereby modulating the vacuum pressure in the pressure chamber. The suction modulation device further includes a processor configured to analyze the measured parameters in response to modulation of the vacuum pressure in the pressure chamber, and to generate or select the modulated therapeutic pressure waveform based on the analysis of the measured parameters.

29. The suction modulation device according to claim 28, wherein the plurality of different modulation diagnostic pressure waveforms each have a different frequency.

30. The suction modulation device according to claim 28 or claim 29, in, The controller is configured to generate the plurality of waveform signals in response to a thrombus occluding the aspiration catheter; and The processor is configured to determine one or more characteristics of the thrombus based on analysis of the measured parameters, and to generate or select the modulated therapeutic pressure waveform based on the determined characteristics of the thrombus.

31. The suction modulation device according to claim 28 or claim 29, in, When the suction conduit is connected to the suction modulation device, the controller is configured to generate the plurality of waveform signals; and The processor is configured to determine the type of the aspiration catheter based on analysis of the measured parameters, and to generate or select the modulated therapeutic pressure waveform based on the determined type of the aspiration catheter.

32. The suction modulation device according to any one of claims 1-31, further comprising: The main unit includes a first housing that accommodates the controller; and The slave unit includes a second housing that houses at least a portion of the fluid pressure oscillator and the pressure manifold.

33. The suction modulation device according to claim 31 further includes a flexible fluid conduit for fluidly coupling the main unit and the slave unit to each other.

34. The suction modulation device according to claim 32, wherein the master unit is configured to be inserted into the second housing of the slave unit.

35. The suction modulation device of claim 34, wherein the master unit is configured to be electrically coupled to the slave unit when inserted into the second housing of the slave unit.

36. The suction modulation apparatus according to any one of claims 1 to 35, wherein the fluid pressure modulated by the fluid pressure oscillator is the baseline vacuum pressure applied to the pressure chamber by the vacuum source.

37. A suction system, comprising: The suction modulation device according to any one of claims 1-36; The vacuum source; and The suction catheter.

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