CN118946722A - Device and method for removing material from a patient's body - Google Patents

Abstract

A pumping assembly is used to remove material from a patient's body. The pumping assembly is oriented toward the distal end of a catheter and can be advanced through a blood vessel. The stator and rotor form a tissue engaging portion of the pumping assembly and remove material from the patient's body when the rotor spins.

Description

Apparatus and method for removing material from a patient

Cross Reference to Related Applications

The present application claims the benefit of each of U.S. provisional patent application Ser. No.63/315,764, entitled "DEVICES AND METHODS FOR ADMINISTERING AND REMOVING MATERIAL FROM A PATIENT", filed 3/2, U.S. provisional patent application Ser. No.63/359,990, entitled "DEVICES AND METHODS FOR REMOVING UNWANTED MATERIALFROMAPATIENT", filed 11/7/2022, and U.S. provisional patent application Ser. No.63/415,201, entitled "DEVICES AND METHODS FOR REMOVING UNWANTED MATERIAL FROM A PATIENT", filed 11/10/2022. The entire contents of the foregoing application are incorporated herein by reference for all purposes.

Technical Field

The present disclosure relates generally to the field of medicine, and more particularly to the field of interventional radiology. Described herein are devices and methods for removing unwanted material from a patient.

Background

Removal of material from the patient's body is an important part of routine and urgent medical care. For example, in the field of interventional radiology, removal of a clot (which includes a thrombus or thromboembolism) from a blood vessel or vascular graft is known as thrombectomy, and a variety of devices have been proposed to meet this need. Limitations of some existing devices include, but are not limited to, large blood loss during clot extraction, difficulty in removing multiple clot compositions including both soft and hard clots, difficulty in removing clots adhering to the vessel wall, damage to the vessel during clot extraction, large device size, clot disruption during removal and subsequent embolization, and the amount of capital equipment required to operate the device. A device that can remove material (e.g., clots, stones, malignant tissue) from a body lumen or cavity and overcome some or all of these limitations would be advantageous.

Disclosure of Invention

The present invention relates to an apparatus and method for removing material from a patient. In one application, the apparatus and method are used to remove a clot during a thrombectomy procedure. The apparatus may include a tissue engaging portion, a pumping assembly, a catheter body, a handle assembly, and a collection assembly. When the device is activated, the clot is engaged by the tissue engagement section, pulled into the pumping assembly, and then gradually pumped into the catheter body, through the handle assembly and into the collection assembly, thereby removing the clot from the blood vessel.

In one embodiment, the pumping assembly includes a rotor and a stator that form a cavity or pocket that transfers material through the cavity or pocket and into the catheter body as the rotor rotates. In one embodiment, the pumping assembly is a progressive cavity pump. In one example, the rotor extends into the tissue engaging portion at a distal end of the device. When activated, the tissue-engaging portion creates a mechanical and/or vacuum-assisted engagement of the clot and material (e.g., blood and clot) such that they are ingested from the distal end of the tissue-engaging portion and into a pumping assembly configured to create sufficient pressure to move the material into the catheter body, through the handle assembly, and into the collection assembly. The tissue engaging section may also help minimize clot disruption and subsequent embolization. Blood loss can also be minimized by engaging clots, optimizing the size of the cavity, and controlling the rotational speed of the rotor.

In some cases, the pumping assembly may also be configured to be positioned at a predetermined or adjustable angle to the axis of the catheter body. In this case, the catheter body may be rotated via the handle assembly to better engage clots in a larger vessel or adhered to the vessel wall. This may also allow smaller devices to be utilized.

In some embodiments, the pumping assembly may be slidably positioned within the engagement conduit to assist in the ingestion of material into the conduit.

The foregoing is a summary and may be limited in detail. The above-mentioned aspects and other aspects, features and advantages of the present technology are described below in connection with various embodiments, with reference to the specification, claims and drawings.

Drawings

Fig. 1A illustrates an embodiment of an apparatus according to the present disclosure in an isometric view.

Fig. 1B illustrates an exploded component view of the device of fig. 1A.

Fig. 2A illustrates the device of fig. 1A in a detailed view of the distal end.

Fig. 2B illustrates the apparatus of fig. 1A in an exploded component view.

Fig. 2C illustrates a front view of the pumping assembly with dimensions.

Fig. 2D illustrates a side view of the pumping assembly with dimensions.

FIG. 2E illustrates a representative flow equation for a pumping assembly.

Fig. 3A illustrates the device of fig. 1A in an initial configuration, wherein the stator and distal sleeve are transparent.

Fig. 3B illustrates the apparatus of fig. 1A, wherein the rotor is partially rotated and the first cavity begins to form.

Fig. 3C illustrates the apparatus of fig. 1A wherein the rotor is further rotated.

Fig. 3D illustrates the apparatus of fig. 1A, wherein the rotor is further rotated and a second cavity begins to form.

Fig. 3E illustrates the apparatus of fig. 1A wherein the rotor is further rotated.

Fig. 3F illustrates the apparatus of fig. 1A, wherein the rotor is further rotated and a third cavity begins to form.

Fig. 4 illustrates an embodiment of a handle assembly of the apparatus of fig. 1A in an exploded component view.

Fig. 5 illustrates a cross-sectional view of the handle assembly of fig. 4.

Fig. 6A illustrates the device of fig. 1A in proximity to a clot within a blood vessel.

Fig. 6B illustrates the device of fig. 1A ingesting a clot.

Fig. 6C illustrates the device of fig. 1A further ingesting a clot.

Fig. 6D illustrates the device of fig. 1A further ingesting a clot.

Fig. 6E illustrates the device of fig. 1A having ingested a clot.

Fig. 7 illustrates an embodiment of a device according to the present disclosure to remove a clot from an iliac vein.

Fig. 8 illustrates an embodiment of a method of using the apparatus of fig. 1A.

Fig. 9A illustrates a pumping assembly that may be incorporated into embodiments of the present disclosure.

Fig. 9B illustrates an alternative pumping assembly that may be incorporated into embodiments of the present disclosure.

Fig. 10A illustrates another alternative pumping assembly that may be incorporated into embodiments of the present disclosure.

Fig. 10B illustrates an exploded component view of the embodiment shown in fig. 10A.

Fig. 11A illustrates the device of fig. 10A in an initial configuration in a cross-sectional view.

Fig. 11B illustrates the apparatus of fig. 10A in which the rotor is partially rotated.

Fig. 11C illustrates the apparatus of fig. 10A wherein the rotor is further rotated.

Fig. 12A illustrates an embodiment of a device having an aspiration channel and an infusion channel.

Fig. 12B illustrates an exploded component view of the embodiment shown in fig. 12A.

Fig. 13A illustrates an embodiment of an apparatus having a uniform wall thickness stator.

Fig. 13B illustrates an exploded component view of the embodiment shown in fig. 13A.

Fig. 14A illustrates an embodiment of a tissue engaging portion of a device according to the present disclosure and including an extension feature.

Fig. 14B illustrates an embodiment of an alternative tissue engagement portion including a stator funnel.

Fig. 14C illustrates an embodiment of yet another tissue engaging section including a rotor extension end.

Fig. 14D illustrates an embodiment of another tissue engagement portion including an extension wire.

Fig. 14E illustrates an embodiment of another tissue engaging section including capped ends.

Fig. 14F illustrates an embodiment of another tissue engagement section including a standoff.

Fig. 14G illustrates an embodiment of another tissue engagement section including an infusion outlet.

Fig. 14H illustrates an embodiment of another tissue engagement section including an infusion outlet.

Fig. 15A illustrates an embodiment of a device according to the present disclosure including a guidewire access port.

Fig. 15B illustrates a cross-sectional view of the apparatus of fig. 15A.

Fig. 15C illustrates a side view of a device having a plurality of distal bends.

Fig. 16A illustrates a front view of a device according to the present disclosure including a visualization component.

Fig. 16B illustrates an isometric view of the apparatus of fig. 16A.

Fig. 16C illustrates an exploded view of the device in fig. 16B.

Fig. 17A illustrates a front view of a device according to the present disclosure including two visualization components.

Fig. 17B illustrates an isometric view of the apparatus of fig. 17A.

Fig. 17C illustrates an exploded view of the device in fig. 17B.

Fig. 18A illustrates a suction catheter approaching a clot within a blood vessel.

Fig. 18B illustrates a suction catheter engaging the clot of fig. 18A.

Fig. 18C illustrates an apparatus according to the present disclosure engaged with the clot of fig. 18A.

Fig. 18D illustrates the device of fig. 18C removing the clot of fig. 18A.

Fig. 18E illustrates removal of the clot of fig. 18A.

Fig. 19A illustrates an embodiment of an apparatus according to the present disclosure including a filter.

Fig. 19B illustrates the apparatus of fig. 19A, wherein the filter is shown in an exploded view.

Fig. 19C illustrates another embodiment of an apparatus according to the present disclosure including a series of filters.

Fig. 20 illustrates an embodiment of an apparatus according to the present disclosure with a catheter filter.

Fig. 21 illustrates an embodiment of a device according to the present disclosure with an expandable funnel.

Fig. 22 illustrates an embodiment of an apparatus according to the present disclosure having a pumping assembly in the handle.

Detailed Description

Conventional and known removal devices include a variety of mechanisms and methods for removing unwanted material from a patient. Some devices include aspiration catheters that use a vacuum pump connected to the catheter to aspirate material such as thrombus from a blood vessel like a suction tube. Aspiration catheters can be challenged by more viscous materials (such as subacute or chronic clots) that do not readily compress into the catheter lumen and, thus, can clog such devices. In addition, aspiration catheters can deleteriously produce significant aspiration flow and thus remove large amounts of blood from the patient. Doing so increases the risk of exsanguination and the likelihood of requiring blood transfusion, as well as other risks.

Certain conventional removal devices have been described that use an expandable metal frame and basket to mechanically grasp unwanted material, such as a clot, in order to pull the material from the blood vessel. These devices can sometimes cause vascular damage to the intimal wall, venous valves, or other tissue structures, particularly as they are removed from the patient. In addition, these devices may sometimes allow debris of unwanted material to plug and travel further downstream in the blood vessel, increasing the risk of developing other problems such as pulmonary embolism or stroke.

Still other conventional devices use a spinning element to chop unwanted materials, which may include thrombus and wall-adherent plaque. Devices with spinning elements can cause significant damage to vascular structures while also being prone to clogging, particularly as compared to other material removal devices and methods. These devices also often require large capital equipment to control them, and may require a separate suction source to remove the material once it has been shredded.

Described herein are devices and methods that overcome the previously described challenges, etc., while providing substantial additional benefits related to removing unwanted materials from within a patient. During use, the disclosed devices are typically inserted into a physiological lumen or cavity of a patient in close proximity to the material to be removed from the patient. In one aspect of the disclosed apparatus, the apparatus includes a pump for generating suction such that there is a low dead volume between the pump and unwanted material to be removed. In some embodiments, the pump is a positive displacement pump that is located within the lumen of the catheter and may even be located at the distal tip of the catheter such that the dead volume or fluid volume between the pump and the in situ unwanted material is minimized and may even be negligible. By reducing the amount of dead space, the pump can provide a greater vacuum to unwanted material due to minimal head loss through the tubing. The pump may then expel unwanted material out of the patient through the lumen of the catheter. Additionally, positive displacement pumps are beneficial in that they do not require large flows to generate high levels of vacuum and thus can minimize blood loss associated with conventional aspiration catheters.

Positive displacement pumps move fluids by repeatedly closing a fixed volume and mechanically moving it through the system in a cyclic motion. Examples of positive displacement pumps include piston pumps, diaphragm pumps, gear pumps, lobe pumps, vane pumps, and progressive cavity pumps. While each of these pump types may be used for material removal and are within the scope of the present disclosure, progressive cavity pumps (also known as Moineau pumps, eccentric screw pumps, or screw pumps) are particularly well suited for removing unwanted material from a patient. A progressive cavity pump includes a stator having a slotted helical cavity and a spin screw rotor. The stator and rotor are designed such that when they meet one or more cavities are formed between the helical rotor and the stator helical cavity. As discussed in further detail below, the cavity may be a contained fluid volume that may be completely sealed (e.g., due to an interference fit between the rotor and stator, which may be facilitated by the stator being formed of an elastomeric material). Alternatively, the present disclosure contemplates that the stator and rotor may be sized such that the two components are not sealed. Among other advantages, such a "leakage" configuration may reduce the volume of certain fluids (e.g., blood) transferred by a progressive cavity pump, while still facilitating the aspiration of solid/semi-solid materials and more viscous fluids. In the case of blood, the result may be reduced blood loss and reduced risk of the patient needing blood transfusion.

In certain embodiments of the present disclosure, the pitch of the helical rotor is about half the pitch of the stator helical cavity. Spinning the rotor causes one or more cavities to move along the axis of the pump, depending on the direction of the rotor spin. Progressive cavity pumps are unique over other pumps in that they incorporate a helical element, such as an archimedes screw pump, also known as a water screw pump. Typical designs of archimedes screw pumps include cylindrical screws that spin within a cylindrical or tubular lumen. Such pumps do not include or form a closed cavity between their stator and rotor and typically utilize a pressure differential created by the rotational speed of the screw to draw fluid into the pump. Some archimedes screw designs may work well enough for pumping viscous fluids such as blood, but may be challenged by more viscous materials such as thrombus. In contrast, progressive cavity pumps form a series of closed cavities that may be fully or partially sealed. During operation, the progressive cavity pump moves a discrete volume for each rotation of the rotor. As a result, the output of progressive cavity pumps is proportional to the number of revolutions of the rotor and independent of the rotational speed (as is the case with pressure-based pumps such as conventional screw pumps). Thus, progressive cavity pumps have applications, such as dosing applications, where it is desirable to well control the amount of material pumped. The controlled flow provided by the progressive cavity pump is also advantageous in the case of material removal, as it overcomes some of the challenges associated with existing thrombectomy devices in which excessive blood loss is difficult to control. Furthermore, as briefly noted above, progressive cavity pumps are also well suited for applications in which the pumped material is viscous or a slurry comprising a solid material, such as thrombectomy procedures, and may overcome some of the limitations of existing thrombectomy devices that are plugged with more viscous materials. However, progressive cavity pumps tend to be too large, too expensive and too complex to be viable for use in catheters. For example, conventional progressive cavity pumps are commonly used in large scale applications such as pumping of sewage or oil. In such applications, progressive cavity pumps have considerable mechanical complexity due to the need for various bearings and gimbals.

In certain embodiments, the progressive cavity pump may further include elements that improve material removal. For example, the distal end of the pumping assembly may include a tissue engaging portion configured to ingest elastic and viscous material into the pumping assembly by mechanically grasping or pinching the material and applying suction.

In fig. 1A, an apparatus 102 for removing material from a patient (e.g., from a blood vessel) is shown. The device 102 includes a tissue engaging portion 108, a pumping assembly 110, a catheter body 104, a handle assembly 106, and a collection assembly 112. The tissue-engaging portion 108 is configured to engage the material via mechanical interaction with the material and/or via the generation of suction flow or vacuum pressure that draws the material into the tissue-engaging portion 108.

Fig. 1B depicts additional details of device 102. In the illustrated embodiment, pumping assembly 110 includes a stator 114, a rotor 116, a distal sleeve 120, and a positioning element 118. The stator 114 fits within a distal sleeve 120, which distal sleeve 120 is connected to the catheter body 104 and the positioning element 118. The rotor 116 is attached to and rotates with the torque member 122. The handle assembly 106 includes a catheter hub 124 for rotating the catheter body 104, a housing made up of two shells 126, a drive system 130 for enabling rotation of the torque member 122, a manifold 128 for sealing the drive system 130 from the removed material and for directing the removed material to the collection assembly 112 through an outlet tube 132. Handle assembly 106 also includes a cable 134 and a controller 136.

In one embodiment, pumping assembly 110 is a progressive cavity pump in which a series of cavities are formed between rotor 116 and stator 114 that move proximally when rotor 116 spins in one direction and move distally when rotor 116 spins in the opposite direction. Progressive cavity pumps are known by other names such as eccentric screw pumps, progressive cavity pumps, or Moineau pumps. Progressive cavity pumps are well suited in applications requiring fluid metering, pumping of viscous or shear sensitive materials, and pumping of slurries containing abrasive solids.

In fig. 2A, a detailed view of the distal end of the device 102 is shown, and further illustrates the tissue engagement portion 108 and the pumping assembly 110. In general, the tissue engaging portion 108 includes elements that mechanically engage tissue to facilitate subsequent uptake of the tissue by the device 102. In certain embodiments, the tissue-engaging portion 108 includes a rotor distal tip 212 (indicated in fig. 2B) of the rotor 116, a stator distal section 202 of the stator 114, a slot 220 defined by the stator 114, and a portion of the distal sleeve 120.

In the illustrated embodiment, the stator distal section 202 extends from the distal sleeve 120 and is oriented with stator alignment features 204. The stator alignment feature 204 provides rotational orientation between the stator 114 and the distal sleeve 120. The slot 220 allows the rotor distal tip 212 of the rotor 116 to move therein and creates an open cavity 222 at the distal end of the device 102. As the rotor 116 rotates, the rotor distal tip 212 spins and translates across the slot 220. This action mechanically engages the material (e.g., by pinching or trapping the material between the rotor distal tip 212 and the wall defining the slot 220). The pumping assembly 110 may also generate a suction flow and/or vacuum pressure to draw tissue/material into the open cavity 222. By doing so, the device 102 ingests material into the pumping assembly 110 for subsequent removal from the patient.

In certain embodiments, the distal sleeve 120 may include a distal bend 206, the distal bend 206 orienting the distal sleeve 120 at an angle relative to the catheter body 104. Distal bend 206 may enhance the ability of tissue-engaging portion 108 to engage material (e.g., clot) adhering to the vessel wall and/or increase the reach of device 102, e.g., to treat larger vessels without requiring larger diameter devices. In some embodiments, the distal bend 206 may be adjustable or formable. For example, the catheter body 104 may include one or more steering features (e.g., pulling cables) that may be used to steer and lock the distal bend 206.

As previously noted, the stator 114 includes a slot 220 (which may be oblong in shape) at its distal face. Slots 220 continue helically through stator 114 to form stator toroidal cavity 210. In certain embodiments, the stator 114 may be formed of an elastomeric material, such as silicone, polyurethane, or any other suitable material that may be molded or otherwise formed to include the stator toroidal cavity 210. The use of an elastomeric material facilitates, among other things, the sealing of the stator 114 against the rotor 116. In certain non-limiting examples, the stator 114 material may have a durometer hardness of from about shore 20A and including from about shore 20A to about shore 100D and including about shore 100D, or from about shore 20A and including from about shore 20A to about shore 60D and including about shore 60D, or about shore 80A. In other embodiments, the stator may be constructed of a more rigid material such as plastic, stainless steel, or any other suitable material.

The rotor 116 generally has a rotor helical section 214, the rotor helical section 214 having a geometry similar to the stator helical cavity 210, albeit with a reduced pitch. For example, in certain embodiments, the pitch of the rotor helical section 214 may have about half the helical pitch of the stator helical cavity 210 (or in other words, the stator helical cavity 210 may have about twice the pitch of the rotor helical section 214). Alternative geometries of stator helical cavity 210 and rotor helical section 214 may be configured to have similar functions and will be discussed further later in this disclosure.

The rotor 116 may be formed from a variety of materials including, but not limited to, nylon, polycarbonate, stainless steel, nitinol, or any other suitable material (e.g., other plastic or metal). In certain embodiments, the rotor 116 may be formed of a plastic material and may be formed using one or more of injection molding, 3D printing, extrusion, or similar manufacturing methods. In general, however, the rotor 116 may be formed of a harder or more rigid material than the material of the stator 114. The selection of a harder/stiffer material for the rotor 116 and a more resilient/compliant material for the stator 114 facilitates, among other things, a seal between the rotor 116 and the stator 114 during operation.

The geometry of the stator 114 and the rotor 116 generally form a helical contact or near contact path. During operation, at least one closed cavity 224 is formed in the space between the rotor helical section 214 and the stator helical cavity 210. More specifically, as the rotor 116 rotates within the stator 114, a cavity is formed between the rotor 116 and the stator 114 and travels proximally toward the catheter body 104 as the rotor 116 rotates. For example, fig. 2D illustrates each of an open cavity 222 and a closed cavity 224. During operation, material is initially captured within the open cavity 222. As the rotor 116 further rotates, the open cavity 222 moves proximally and eventually closes, forming a closed cavity, such as closed cavity 224. As the rotor 116 rotates further relative to the stator 114, the closure cavity 224 eventually advances to the proximal end of the stator helical cavity 210 and opens, releasing captured material into the catheter body 104. In this manner, material drawn into the pumping assembly 110 is captured within the closed cavity 224 and subsequently moved into the catheter body 104 for removal from the patient. Among other advantages, the method allows for removal of material (e.g., clots) without removing excess fluid (e.g., blood).

In one embodiment, the closed cavity 224 is fluid tight. For example, the seal may be achieved by contact between the stator 114 and the rotor 116, and in some embodiments where the stator 114 and the rotor 116 have an interference fit, additional compression of the stator 114 by the rotor 116. For example, the compression of the stator 114 by the rotor 116 may be from about 0% and including about 0% to about 40% and including about 40%, or from about 2% and including about 2% to about 10% and including about 10%, or about 5%. The compression need not be the same along the entire length of the contact between the stator 114 and the rotor 116.

In other embodiments, the closed cavity formed between the stator 114 and the rotor 116 may not be fluid tight, i.e., there may be a gap between the rotor 116 and the stator 114. Even without a completely sealed cavity, the pumping assembly 110 may still function similarly to the case with a sealed cavity, particularly for removing solid material. In certain embodiments, the spaced gap may advantageously reduce friction between the stator 114 and the rotor 116 due to lack of contact or elastic interference between the two components. The clearance gap may also allow for greater tolerance variations of the rotor 116 and stator 114, and may enable both components to be made of rigid materials. The inclusion of a clearance gap may also reduce the flow through pumping assembly 110, for example, by allowing fluid to leak distally from pumping assembly 110. Among other advantages, such leakage may result in the removal of solid or semi-solid material from the patient's body without removing significant amounts of blood or other fluids. For example, the ratio of removed blood to removed clot may be from about 1:10 and including about 1:10 to about 50:1 and including about 50:1, or from about 1:1 and including about 1:1 to about 20:1 and including about 20:1, or about 10:1. For the purposes of this disclosure, and unless otherwise indicated, a cavity described as "closed" in this disclosure should be considered to encompass both fluid-tight and unsealed cavities.

The illustrated pumping assembly 110 includes a distal sleeve 120 for containing the stator 114 and may provide support such that the stator 114 may be compressed between the rotor 116 and the distal sleeve 120 to allow for the formation of a closed cavity, such as closed cavity 224. The stator 114 generally includes a stator body section 208, the stator body section 208 being sized to fit within the distal sleeve 120. The distal sleeve 120 may be an integral part of the catheter body 104, or may be a separate part attached to the catheter body 104, as shown in fig. 2B. The distal sleeve 120 is connected to the catheter body 104 such that the stator distal section 202 maintains a tubular profile.

Some embodiments include a distal bend, the distal bend 206 in the distal sleeve 120 generally angles the tip of the device away from the axis of the catheter body 104. The angle of the distal bend 106 may be from about 0 ° and include about 0 ° to about 75 ° and include about 75 °, or from about 10 ° and include about 10 ° to about 45 ° and include about 45 °, or about 20 °.

In certain embodiments, distal sleeve 120 may be a laser cut stainless steel or nitinol tube, plastic tube, injection molded component, machined component, or have any other suitable configuration.

In certain embodiments, pumping assembly 110 may include a positioning element 118, which positioning element 118 resides inside distal sleeve 120 and engages stator 114 and rotor hub 216 such that the axial position of rotor 116 is maintained relative to stator 114. The positioning element may include a distal hard stop, a proximal hard stop, or other alignment feature that axially and rotationally positions the rotor 116 or stator 114. The positioning element 118 ensures that the distal end of the rotor 116 is in the correct axial position, and in some embodiments does not extend beyond the distal end of the stator distal section 202, among other things, which could lead to vascular damage. The locating element 118 may further engage internal features (e.g., shoulders, slots, protrusions, keys, keyways, etc.) within the distal sleeve 120 such that the position and orientation of the stator 114 relative to the distal sleeve 120 is maintained. In some embodiments, the positioning element 118 is a separate component, and in other embodiments, the positioning element 118 is a feature of the stator 114 or distal sleeve 120 (e.g., integrally formed or coupled to the stator 114 or distal sleeve 120).

The torque member 122 is connected to the rotor 116 (e.g., via the rotor hub 216) such that when the torque member 122 spins, the rotor 116 spins as well. The torque member 122 may be of many configurations, such as a wire rope, cable, tube, wire, or any other suitable configuration for spinning the rotor 116. More generally, the torque member 122 is structured and/or formed of a material such that the torque member 122 has sufficient torsional rigidity to transfer torque to the rotor 116 while maintaining sufficient bending flexibility to facilitate navigation through a patient's physiological lumen. The torque member 122 may be configured differently depending on the particular application to accommodate the need for different flexibilities. For example, in applications involving more tortuous or stiffer physiological lumens, more flexible torque members may be used, while in applications where the patient's physiological lumen is more straight, larger or more flexible, generally stiffer torque members may be used. Torque member 122 may include a torque member crimp 218 at one end that facilitates connection to rotor 116 (e.g., to rotor hub 216). In some cases, the rotor 116 and the torque member 122 are a single component, with the rotor 116 being formed into the torque member 122, integrally formed with the torque member 122, or coupled to the torque member 122.

The device 102 may also include a number of radiopaque materials, such as marker bands or components composed of radiopaque materials, such that the device 102 is visible using fluoroscopy or Computed Tomography (CT) imaging. For example, the distal end of the device 102 may include a band or strip of material such as tantalum, platinum iridium alloy, titanium, gold, tungsten, stainless steel, or any other suitable radiopaque material. A marker band may be placed near the distal tip of the device 102 to provide feedback to the user regarding the position of the tip. In other embodiments, the stator 114 or rotor 116 or distal sleeve 120 may be constructed of a material having a radiopaque additive (such as barium sulfate, bismuth, tungsten, or any other suitable additive).

Fig. 2C and 2D illustrate additional views of pumping assembly 110 and further indicate specific dimensions. In general, the dimensions of the device 102 may be adapted for many applications and configured (e.g., dimensioned) for a particular application. For example, the device 102 may be configured for thrombectomy of deep vein thrombosis. Due to the relatively large vessels and possible amounts of clotting involved in such procedures, embodiments may include configurations in which the outer diameter OD _s of the stator and catheter body 104 may be from about 1mm (3 Fr) and include about 1mm (3 Fr) to about 8mm (24 Fr) and include about 8mm (24 Fr). In one specific example, the outer diameter OD _s can be about 5.3mm or 16Fr. The length L _s of the stator may also vary in different applications. However, as a non-limiting example, in applications involving treatment of deep vein thrombosis, L _s is from about 1mm and includes about 1mm to about 30mm and includes about 30mm or about 10mm.

The total number of rotations of the stator lumen may also vary. For example, in certain embodiments, stator coil cavity 210 may include from about 0.5 revolutions and including 0.5 to about 10 revolutions and including about 10 revolutions or about 1 revolution of stator coil cavity 210.

The cross-sectional diameter D _r of the rotor may also vary. However, in certain embodiments, D _r may be from about 0.1mm and include about 0.1mm to about 4mm and include about 4mm or about 2mm.

In the embodiment shown in fig. 2A-2D, the rotor helical section 214 has a circular profile, however, other geometries are contemplated and are within the scope of the present disclosure.

Stator toroidal cavity 210 may have a stator pitch P _s and rotor helical section 214 may have a rotor pitch P _r that is slightly shorter than P _s. For example, P _r may be from about 0.25 times and including about 0.25 times to about 0.75 times and including about 0.75 times or about 0.5 times P _s. For example, the rotor pitch P _r may be about 5mm, while the corresponding stator pitch P _s may be about 10mm, while the length L _s of the two helical elements may be about 10mm. In such a configuration, stator helical cavity 210 will have about 1 full revolution, while rotor helical section 214 will have about 2 revolutions.

The stator slot 220 may be defined by an eccentricity E _s. In certain non-limiting examples, the eccentricity E _s may be from about 0.1mm and include about 0.1mm to about 4mm and include about 4mm or about 2mm. Similarly, the rotor helical section 214 may be defined by an eccentricity E _r. Rotor eccentricity E _r may be a fraction of stator eccentricity E _s. In certain embodiments, the rotor eccentricity E _r may be from about 0.25 times and including about 0.25 times to about 0.75 times and including about 0.75 times or about 0.5 times the eccentricity of the stator slot E _s. In the illustrated embodiment, for example, the rotor eccentricity E _r may be about 1mm and the stator slot eccentricity E _s may be about 2mm.

As previously noted, and as shown in fig. 2D, the stator 114 and the rotor 116 may be selected to have a gap G therebetween. In some embodiments, the rotor 116 and stator 114 have intentional interference to provide a completely sealed closed cavity 224. In such a case, the gap G may be characterized by a negative value. For example, the gap G may be from about-0.01 mm and include about-0.01 mm to about-0.5 mm and include about-0.5 mm or about-0.05 mm. Alternatively, the negative gap G may be expressed as a percentage of compression as described above.

In embodiments where there is an intentional positive clearance gap G between the rotor 116 and the stator 114, the clearance gap G may be characterized by a positive value. For example, the gap G may be from about 0.0mm and include about 0.0mm to about 1.0mm and include about 1.0mm, or from about 0.05mm and include about 0.05mm to about 0.25mm and include about 0.25mm or about 0.01mm. In such embodiments, the cavity created between the stator 114 and the rotor 116 is an unsealed cavity. The positive clearance gap G (e.g., a non-interference fit between the stator 114 and the rotor 116) may result in lower friction between the stator 114 and the rotor 116, making rotation of the rotor 116 easier, and may allow both the rotor 116 and the stator 114 to be composed of more rigid materials, among other things.

In the illustrated embodiment, each of the closed cavities 224 formed between the stator helical cavity 210 and the rotor helical section 214 has a corresponding volume. Although the volume of each cavity may vary depending on the size and geometry of the components of the device 102, in at least some embodiments, the volume of each cavity may be from about 1 μl and include about 1 μl to about 200 μl and include about 200 μl or about 17 μl.

Since each cavity is formed during rotation of the rotor 116 and represents a fixed volume defined by the space between the rotor helical section 214 and the stator helical cavity 210, the flow rate is approximately proportional to the rotational speed of the torque member 122, which may be adjusted accordingly by the user. Fig. 2E provides an equation for the approximate flow Q of pumping assembly 110 for a given rotational speed Ω of the rotor in radians/second. For example, in the illustrated embodiment, rotor eccentricity E _r is 1mm, rotor diameter D _r is 2mm, and stator pitch P _s is 10mm. The flow rate Q is estimated to be about 40cc/min based on a rotational speed Ω of 1,000rpm or 104 rad/s. Design parameters may be adjusted as needed to alter the properties of the pump assembly, including flow Q, pump pressure, and other characteristics. The rotational speed of the drive system 130 may be in the range of from about 1rpm and including about 1rpm to about 120,000rpm and including about 120,000rpm, or from about 2,000rpm and including about 2,000rpm to about 60,000rpm and including about 60,000rpm, or about 15,000rpm.

The positive clearance gap between the stator 114 and the rotor 116 may reduce the flow of the pumping assembly 110 by allowing fluid to slide between the clearance gaps. This may advantageously reduce the expelled viscous material, such as blood, while still ingesting more viscous or solid/semi-solid materials. In this way, the device 102 may remove more viscous material more preferentially. The equation in fig. 2E does not take into account fluid slippage that may exist if the closed cavity 224 is an unsealed cavity due to a positive clearance gap between the rotor 116 and the stator 114; however, such adjustments may be made, for example, by calculation or based on empirical data. Notably, embodiments that include a positive clearance gap may not generate significant vacuum pressure, thereby further affecting the flow and ingestion characteristics of the pumping assembly 110.

In fig. 3A-3F, the operation of pumping assembly 110 is shown in more detail by making distal sleeve 120 and stator 114 transparent to view the movement of the cavity. In fig. 3A, the device 102 is shown in an initial configuration. The stator 114 is within the distal sleeve 120 and the rotor helical section 214 is within the stator helical cavity 210. The rotor hub 216 is pressed against the positioning element 118 at the proximal end of the stator 114. The torque member 122 is connected to the rotor 116 and moves through the distal bend 206 into the catheter body 104. In this initial configuration, the rotor distal tip 212 is at the top of the slot 220. In some applications, the pumping assembly 110 may have been primed with a fluid such as water, saline, blood, grease, or oil, or conversely, the pumping assembly 110 may be devoid of material.

Fig. 3B is an illustration of the device 102 in an intermediate position with the torque member 122 and rotor 116 partially rotated. As previously discussed, as the rotor 116 rotates, the rotor helical section 214 interacts with the stator helical cavity 210 such that the rotor helical section 214 contacts or nearly contacts the stator helical cavity 210 to define cavities through which material is conveyed through the pumping assembly 110.

As shown, rotor hub 216 interacts with positioning elements 118 to ensure that rotor 116 is in the correct axial position. More specifically, as the rotor 116 rotates clockwise, the interaction between the rotor 116 and the stator 114 results in a distally directed force on the rotor 116. Positioning element 118 is configured to limit distal travel of rotor hub 216 and to maintain distal rotor tip 212 in a desired position at tissue engaging portion 108. In one embodiment, the distal rotor tip 212 does not extend significantly beyond the stator distal section 202 to reduce the risk of vascular injury. As the rotor 116 rotates, the rotor distal tip 212 moves downward within the slot 220 at the distal end and forms a first open cavity 302 in the space between the rotor 116 and the slot 220. The first open cavity 302 is open to the distal end of the pumping assembly 110, allowing fluid or material to enter the stator 114. The material may be blood or clot or any other material to be removed.

As shown in fig. 3C, as the rotor 116 is further rotated, the volume of the first open cavity 302 increases as the first open cavity 302 moves proximally into the pumping assembly 110. In some embodiments, this action creates a negative pressure space that draws in fluid like a syringe. In the case of clot material, the tissue-engaging section 108 may additionally create a mechanical force on the tissue, such as by grasping or pinching the tissue, and pull it into the first open cavity 302. Notably, in fig. 3C, the torque member 122 and the rotor 116 have rotated further such that the rotor distal tip 212 is at the bottom of the slot 220. The first open cavity 302 continues to increase in size and moves proximally along the length of the stator 114, thereby further drawing in fluid or material with suction or mechanical force.

Fig. 3D illustrates the device 102 after further rotation of the rotor 116 (as compared to fig. 3C), which moves the rotor distal tip 212 up and toward its initial position in the slot 220. As shown, the opening of the first open cavity 302 has decreased as the first open cavity 302 moves into the pumping assembly 110. At the same time, the second open cavity 304 has opened at the distal end of the device 102 and fluid or material begins to be drawn into the second open cavity 304. In the illustrated embodiment, the first and second open cavities 302, 304 are separate cavities formed by the contact created between the rotor 116 and the stator 114, and there is limited or no fluid connection between the first and second open cavities 302, 304. In other embodiments where there is a gap between the rotor 116 and the stator 114, there may be a small fluid connection between the first open cavity 302 and the second open cavity 304.

Fig. 3E illustrates the device 102 after further rotation of the rotor 116 (as compared to fig. 3D) such that the rotor distal tip 212 returns to the initial configuration in the slot 220 shown in fig. 3A. As illustrated, the first open cavity 302 shown in the previous figures has transitioned to a first closed cavity 308 that is no longer exposed to the distal opening of the slot 220 and moves proximally within the stator 114 along the pumping assembly 110 as the rotor 116 continues to rotate. In other words, the first closed cavity 308 is a shaped volume within the stator 114 that translates along the axis of the pumping assembly 110. In the illustrated embodiment, the first closed cavity 308 is not fluidly connected to the external environment at the distal end of the pumping assembly 110 or the lumen of the catheter body 104. As further illustrated in fig. 3E, the second open cavity 304 has become more open to the distal end of the pumping assembly 110 and as a result may use vacuum and/or mechanical force to draw in fluid or material.

Fig. 3F illustrates the device 102 after further rotation of the rotor 116 (as compared to fig. 3E). More specifically, the rotor 116 has rotated another half turn such that the rotor distal tip 212 returns to the bottom of the slot 220. As illustrated, the first closure lumen 308 has been moved further proximally until it is in communication with the interior volume of the catheter body 104. In other words, the first closed cavity 308 is now pushed into the distal sleeve 120, and upon further rotation of the rotor 116, fluid or material within the first closed cavity 308 will be expelled out of the pumping assembly 110 and into the catheter body 104. As further illustrated in fig. 3F, the second closed cavity 310 has become completely contained within the stator 114 (e.g., no longer open at the distal end of the pumping assembly 110). Finally, a third open cavity 306 is formed at the distal end of the device 102 between the rotor helical section 214 and the stator helical cavity 210, allowing ingestion of material into the third open cavity 306.

In the manner illustrated in fig. 3A-3F and discussed above, the rotor 116 may continue to rotate such that additional cavities are formed at the distal end of the device 102, translate through the pumping assembly 110, and open into the catheter body 104, each cavity carrying fluid and/or solid or semi-solid material therewith. In other words, fluid and material may be pumped from the environment distal to the device 102 through the pumping assembly 110 and into the catheter body 104 by the pumping action of the pumping assembly 110.

Turning now to fig. 4 and 5, an example embodiment of a handle assembly 106 for use with an apparatus according to the present disclosure is shown. The handle assembly 106 allows a user to control, among other things, certain aspects of the functionality of the device 102, as will be described in more detail below. In the illustrated embodiment, the handle assembly 106 includes a catheter hub 124, a drive system 130, a manifold 128, and a housing including two handle shells 126A, 126B. The catheter hub 124 is connected to the catheter body 104 and is rotatable by a user to rotate the catheter body 104 and, in turn, the distal sleeve 120, the positioning element 118, and the stator 114. Such rotation may be particularly useful when directing the tissue-engaging portion 108 having the distal bend 206 toward a particular region of adhered tissue (e.g., an adhered clot) or blood vessel. This feature effectively increases the reach of the device 102, allowing for larger diameter vessels to be treated without the need for larger devices.

The drive system 130 includes the torque member 122, the torque hub 410, the motor adapter 412, the motor plate 414, the motor 416, the throttle 418, the controller 136, and the cable 134. Torque member 122 is housed within catheter body 104 and into handle assembly 106 to engage drive system 130. The torque member 122 passes through the catheter hub 124 and into the manifold 128. The manifold includes two sealing members 408A, 408B, which sealing members 408A, 408B prevent fluids and materials from entering the drive system 130. The proximal end of the torque member 122 includes a torque member hub 410, the torque member hub 410 configured to be rotated by a motor 416. The motor 416 is attached to a motor plate 414, which motor plate 414 retains the motor 416 within the handle housing 126A, 126B. The motor adapter 412 connects the shaft of the motor 416 to the torque member hub 410 such that rotation of the motor 416 results in rotation of the torque member 122. The cable 134 provides power to the motor 416 and may include control inputs or outputs to the device 102. In other embodiments, the cable 134 may be replaced with a battery inside the handle housing 126A, 126B that replaces an external power source to power the drive system 130. The handle assembly 106 also includes a throttle valve 418 and a controller 136 that allow a user to control aspects of the actuation and/or speed of the motor 416.

The outlet tube 132 is connected to the manifold 128 and directs fluid and material out of the handle assembly 106 and into the collection assembly 112 (shown in fig. 1A) that is external to the handle assembly 106. In other embodiments, the device 102 may collect fluids and materials in a collection assembly 112 located within the handle assembly 106 or the catheter body 104. In other embodiments, the outlet tube 132 or collection assembly 112 may incorporate a filter to separate the clot material from the blood and thereby allow the blood to be reintroduced into the patient.

In some embodiments, the drive system 130 may be manually operated. For example, the motor adapter 412, motor plate 414, motor 414, cable 134, and throttle 418 may be replaced with a mechanism (e.g., knob, crank, handle, gear, etc.) to facilitate manually driving rotation of the torque member 122.

Fig. 5 is a cross-sectional view of handle assembly 106. As previously described, the catheter hub 124 extends from the front of the housing shells 126A, 126B (the shell 126B is shown in fig. 4) and allows the user to rotate the catheter body 104 to guide the tissue-engaging portion 108 (e.g., shown in fig. 1A) around the circumference of the blood vessel. Sealing members 408A, 408B housed within the manifold 128 or disposed on opposite ends of the manifold 128 prevent fluid leakage from the manifold 128. For example, the front sealing member 408A may be engaged with the catheter hub 124 such that the front sealing member 408A maintains a fluid seal within the manifold 128 as the catheter hub 124 rotates. The rear seal member 408B may be engaged with the torque member hub 410 to prevent leakage when the torque member hub 410 is spinning. As shown in fig. 5, torque member hub 410 and motor 416 are connected by motor adapter 412. The outlet tube 132 is connected to the manifold 128 and exits from the handle shells 126A, 126B to the collection assembly 112 (shown in fig. 1A). The throttle valve 418 and the controller 136 may be contained within the handle housing 126A, 126B and retained by the handle housing 126A, 126B, for example, in a handle or gripping portion of the handle assembly 106.

In the illustrated embodiment, the throttle valve 418 is a spring-return potentiometer that changes resistance when the user depresses the extension plunger. Wires from a potentiometer (not shown) are connected to the cable 134. The cable 134 may lead to a power source or mains. In some embodiments, the controller 136 may be external to the handle assembly 106 and adapted to control the rotation and speed of the motor 416 via the cable 134.

The handle assembly 106 shown in fig. 4 and 5 is intended only as a non-limiting example of a handle that may be used in embodiments of the present disclosure. In general, a handle assembly according to the present disclosure allows for actuation of a pumping assembly, for example, by causing a rotor to rotate within a stator of the pumping assembly. As noted above, additional functions provided by the handle may include, but are not limited to, rotating the catheter body and providing a passageway through which captured fluids and materials may be transported, filtered, or otherwise processed. Thus, while fig. 4 and 5 provide example embodiments of handle assemblies, the handle assemblies and associated control hubs for apparatus according to the present disclosure are not limited to the specific configurations shown in fig. 4 and 5.

Fig. 6A-6E illustrate the device 102 at various stages for a clot removal application and in particular a thrombectomy procedure. For example, the process shown in fig. 6A-6F may correspond to thrombus removal for a patient with deep vein thrombosis (where the clot is in the iliac-femoral vein) or pulmonary embolism (where the clot is in the pulmonary artery and blocks normal blood flow). The procedures illustrated in fig. 6A-6E are provided as examples only, and the present disclosure recognizes that the general processes and functions illustrated in fig. 6A-6E may be readily adapted for other clinical applications.

In fig. 6A, the device 102 is shown within a blood vessel 604, the blood vessel 604 having a clot 602 that partially or completely blocks blood flow. In certain applications and procedures, the device 102 may be inserted into the vasculature of a patient and navigated to a blood vessel using standard catheterization techniques and devices.

At the point illustrated in fig. 6A, the user may actuate the device 102, for example, by depressing a throttle valve 418 (shown in fig. 4-5) of the handle assembly 106. Actuation device 102 causes rotation of torque member 122, which torque member 122 in turn causes rotation of rotor 116, thereby activating tissue engagement portion 108 and pumping assembly 110, for example, as described in fig. 3A-3F. Tissue-engaging portion 108 may engage clot 602 and begin to ingest blood and material through pumping assembly 110 and into catheter body 104 and outlet tube 132 (shown, for example, in fig. 1A).

In some embodiments, pumping assembly 110 may generate a vacuum pressure or aspiration flow within blood vessel 604, which may push clot 602 proximally. In some cases, the vacuum pressure may be from about 0.5inHg and include about 0.5inHg to about 29.2inHg and include about 29.2inHg. Alternatively, the device 102 may be advanced (e.g., toward the clot 602) until the tissue engagement section 108 is in contact with the clot 602, as shown in fig. 6B.

In fig. 6B, the device 102 is advanced such that the tissue engaging portion 108 is in contact with the clot 602. As the rotor 116 continues to rotate, fragments of the clot 602 may be pulled into the slot 220 by a suction flow or mechanical force (e.g., grasping or pinching the clot 602 or fragments of the clot 602) and subsequently into the open cavity formed by the tissue engagement section 108 and the pumping assembly 110, as previously discussed. The tissue engaging section 108, which is comprised of tissue contacting elements such as slot 220 and rotor distal tip 212, can mechanically grasp and/or loosen the clot by aspiration. As the lumen moves proximally, clot 602 likewise moves through pumping assembly 110 and out through catheter body 104 and outlet tube 132 and into collection assembly 112.

In fig. 6C, device 102 has removed a portion of clot 602. The removed portion is within the catheter body 104 and pumped out of the patient as previously described. In fig. 6D, the device 102 is advanced further and more of the clot 602 has been removed from the blood vessel 604 by the tissue engagement section 108 and the clot 602 has been ingested into the device 102. In fig. 6E, clot 602 has been completely removed from blood vessel 604 and has been removed from the patient, for example, by transporting clot 602 through catheter body 104, through handle assembly 106, and into collection assembly 112 coupled to handle assembly 106.

In fig. 7, an embodiment of the device 102 is shown in an exemplary clinical application. The clot 602 has formed within the patient's iliac vein 704. The clot 602 restricts blood flow within the blood vessel, thereby creating leg swelling and pain for the patient in the patient's lower limb. Prior to insertion of the device 102, an embolic distal protection element 718 may optionally be placed within the inferior vena cava 702 to prevent any displaced or disrupted portion of the clot 602 from traveling to the heart and lungs. In one embodiment, the distal protection element 718 may be an expandable container, such as a braid that captures clot fragments but allows blood flow. Alternatively, the distal protection element 718 may include a non-porous element, such as a balloon or membrane that completely blocks blood flow. The distal protection element 718 may be inserted through the jugular vein or other suitable access site, and guided into the inferior vena cava 702 by standard interventional techniques, and may then be expanded intravascularly.

Introducer sheath 710 may be placed in popliteal vein 708, popliteal vein 708 providing access to the patient's venous vasculature proximal to clot 602. The device 102 may then be inserted into the introducer sheath 710 and directed toward the clot 602 using standard interventional techniques. In some embodiments, a longer introducer sheath or guide catheter is first placed proximal to clot 602, and then device 102 is inserted through the sheath or guide catheter. Many methods of navigating the device 102 to the clot 602 are contemplated. The catheter body 104 extends through the introducer sheath 710, through the popliteal vein 708, through the femoral vein 706, and to the proximal end of the clot 602 within the iliac vein 704.

In the illustrated embodiment, the collection assembly 112 includes a filter assembly 712. The filter assembly 712 may include a series of meshes, such as mesh 714, that may separate the clot 602 from the blood after ingestion by the device 102. The mesh may have a pore size that may be in the range from about 1 μm and including about 1 μm to about 500 μm and including about 500 μm or about 200 μm. In some embodiments, there may be multiple mesh sheets with different pore sizes for removing different component sizes. The filter assembly 712 may include a return tube 716, the return tube 716 being connected to a port on the introducer sheath 710 that allows for reintroduction of the separated blood into the patient. In alternative embodiments, the return tube 716 may be connected to a separate vascular access site. The filter assembly 712 advantageously prevents excessive blood loss from the patient by returning blood to the vasculature while allowing removal of clots or other similar materials.

In the exemplary clinical application shown in fig. 7, the device 102 is actuated by a user with a corresponding control (e.g., throttle 418 of the handle assembly 106) and clot material and blood are removed from the patient as described in fig. 3A-3F. After removing some or all of clot 602, device 102 and distal protection element 718 may be removed.

In other embodiments, the device 102 may access the clot 602 from above (i.e., in the opposite direction) via an access site in the jugular vein. In such embodiments, the distal protection element 718 may optionally be configured to be located on the catheter body 104 or the distal sleeve 120. Alternatively, the device 102 may be inserted through the distal protection element 718 by, for example, incorporating it into the introducer sheath 710 or the guide catheter.

In fig. 8, a method 800 for treating a patient to remove material from a lumen or cavity is provided. In step 802, a device according to the present disclosure is inserted into a patient and positioned into a lumen or cavity containing a material.

In step 804, the device may be advanced into proximity to or in contact with the material, depending on whether suction is to be used to draw the material into the tissue-engaging portion of the device.

In step 806, the device is actuated to begin ingestion of material into the device. In some embodiments, actuating the device may include actuating a pumping assembly of the device. As previously discussed, such actuation may engage the material and begin drawing the material into the catheter body of the device. For example, in embodiments in which the apparatus is brought into contact with the material in step 804, actuating the pumping assembly may cause the pumping assembly to mechanically engage the material. Instead of or in addition to mechanical engagement and delivery, actuation of the pumping assembly may also create suction that draws material into the pumping assembly. Finally, actuation of the device may also or alternatively include applying a separate suction source to draw material into proximity to or into contact with the tissue engaging portion of the device. The material may then be further captured by actuating the pumping assembly of the device, for example by mechanical engagement or aspiration/suction.

In step 808, material is ingested into the device and thereby partially or completely removed from the lumen or cavity by repositioning the tissue engaging section or pumping assembly as desired. This may include advancing or retracting the device and/or rotating the tissue engaging portion or pumping assembly via the catheter hub.

In step 810, the removed blood and material are typically collected for disposal. Collection for disposal may include filtering material from other fluids (e.g., blood) to remove particulates and allow reintroduction of the fluid (e.g., blood) into the patient.

In step 812, the device is removed from the lumen or cavity within the patient, thereby substantially completing the clinical procedure.

In some embodiments, pumping assembly 110 may be longer than the exemplary embodiments shown in fig. 3A-3F. For example, in the embodiment shown in fig. 3A-3F, stator coil cavity 210 has approximately one revolution, which allows rotor 116 to form a single closed cavity 224 within stator 114. For purposes of this disclosure, such an arrangement is commonly referred to as a single stage pump/single stage pumping assembly.

Referring to the dimensions shown in fig. 2C and 2D, in other embodiments, additional stages may be added by increasing the length L _s of the stator and the number of rotations within the stator toroidal cavity 210 and/or by decreasing the pitch P _s of the stator. Such modifications may increase the number of closed cavities 224 formed by the rotor 116 and stator 114 during operation. The additional stages of the pump may allow the pumping assembly 110 to generate a higher head pressure than a single stage embodiment, among other things.

In view of the foregoing, in some embodiments, pumping assembly 110 comprises at least a single stage; however, in other embodiments, pumping assembly 110 may include any suitable number of stages, including, but not limited to, two (2) stages, three (3) stages, or up to five (5) stages. In still other embodiments, pumping assembly 110 may include more than five (5) stages, e.g., up to 100 stages. In the latter embodiment, the pumping assembly 110 may extend along a substantial portion of the catheter body 104 up to the entire length. In other embodiments, pumping assembly 110 may not include a complete single stage such that stator toroidal cavity 210 has less than one helical revolution.

Fig. 9A and 9B illustrate additional embodiments of the present disclosure. In fig. 9A, stator helical cavity 210 and rotor helical section 214 form three (3) closed cavities. The stator/rotor configuration, including more cavities, may achieve higher pressures, and may allow for reduced compression seals or clearance gaps between the rotor 116 and the stator 114, such that the formed cavities are unsealed cavities, among other things.

Fig. 9A illustrates an example apparatus in which the rotor distal tip 212 is generally circular and the stator helical cavity 210 approximates an oblong slot 220 in the front view shown. In contrast, fig. 9B illustrates an alternative embodiment in which the profile of the rotor distal tip 212 has an oval shape and the stator toroidal cavity 210 approximates a triangular slot 220 with rounded corners. Such a configuration may create a plurality of open cavities in tissue-engaging section 108, as shown by first open triangular cavity 902 and second open triangular cavity 904, among other things. The embodiment shown in fig. 9B includes ten (10) closed cavities along its length, with a shorter pitch than the embodiment shown in fig. 9A.

More generally, the stators and rotors of embodiments of the present disclosure may be configured to form any number of cavities during operation. For example, in certain embodiments, the stator and rotor may be configured to form from one and include a single cavity to about 200 cavities and include about 200 cavities. Embodiments including a relatively high number of cavities may be facilitated by extending the stator 114 a substantial proportion of the length of the catheter body 104 with the stator helical cavity 210 and the rotor helical section 214 extending therethrough, up to the entire length of the catheter body 104. In other embodiments, the rotor helical section 214 may be longer than the stator helical cavity 210 such that it extends out of the proximal end of the stator 114 into the distal sleeve 120 or catheter body 104.

Fig. 10A and 10B illustrate another alternative embodiment of the device 102. More specifically, in the example of fig. 10A and 10B, the distal sleeve 120 is substantially straight and in line with the axis of the catheter body 104. This is in contrast to some of the previously discussed embodiments in which the device 102 includes a distal bend. In one specific example of the embodiment shown in fig. 10A and 10B, the length L _s of the stator may be about 20mm long, and the rotor 116 may include a short straight section between the rotor helical section 214 and the rotor hub 216 (shown in fig. 10B). Fig. 10B also illustrates rotor hub 216 as including a helical cut that may advance ingested material into catheter body 104 during operation/rotation of rotor 116.

Fig. 11A to 11C illustrate the operation of the embodiment shown in fig. 10A and 10B. As illustrated, the rotor hub 216 engages the positioning element 118, which positioning element 118 is shown as an integral part of the distal sleeve 120. The locating element 118 feature axially locates the rotor 116 relative to the stator 114 such that the rotor distal tip 212 is flush with the end of the stator distal section 202 at the tissue engaging portion 108. In fig. 11A, pumping assembly 110 is in an initial configuration with rotor distal tip 212 at the top of slot 220. At the slot 220, the space between the rotor helical section 214 and the stator helical cavity 210 creates a first open cavity 302, which first open cavity 302 is open to the distal end of the device 102, allowing fluid and material to enter the first open cavity 302.

In fig. 11B, the rotor 116 is rotated about one quarter turn relative to the configuration shown in fig. 11A. As a result of the rotation, the rotor distal tip 212 has moved down to about half of the open slot 220. As the cavity volume moves into the pumping assembly 110, the opening to the first open cavity 302 decreases. The second open cavity 304 has been opened and fluid or material may similarly enter the cavity. The first open cavity 302 and the second open cavity 304 may be discrete fluid spaces that are partially or completely sealed from each other.

In fig. 11C, the rotor 116 is rotated another quarter turn relative to the configuration shown in fig. 11B. As a result, the rotor distal tip 212 is now at the bottom of the slot 220. The first closed cavity 308 is no longer substantially connected to the distal end of the device 102 and has completely moved within the stator 114. The second open cavity 304 is now fully open to the distal end of the pumping assembly 110 and fluid or material continues to be ingested into the cavity. As the rotor 116 continues to rotate, the first closed cavity 308 will be pumped into the catheter body 104 and then the second open cavity 304 will likewise be pumped into the catheter body 104. The process continues with the formation of a new cavity at the stator distal section 202, which is then ingested into the stator 114 and pumped into the catheter body 104. Thus, the assembly acts like a progressive cavity pump, taking material into the stator 114 and expelling it into the catheter body 104.

In fig. 12A and 12B, an embodiment of a device 1200 of the device 102 is shown that includes one or more additional channels 1202, 1204 in the tissue engagement portion 108 to facilitate infusion and/or aspiration. More specifically, and in contrast to the previous embodiments, the stator distal section 202 is modified to include one or more additional channels that are fluidly connected to the catheter body 104.

In fig. 12A, a suction inlet 1202 where material can be removed and an infusion outlet 1204 where material can be delivered are shown. In fig. 12B, the embodiment of fig. 12A is shown in more detail in an exploded view. As shown, the stator 114 has a channel along its outer surface that allows direct fluid communication between the distal end of the device 102 and the catheter body 104. In some embodiments, the channels are lumens extending through the stator 114 or distal sleeve 120. The suction channel 1206 connects the suction inlet 1202 and the suction outlet 1210 in the distal sleeve 120. An infusion channel 1208 connects the infusion outlet 1204 with an infusion port 1212 in the distal sleeve 120. The suction channel 1206 may be used to apply suction through a separate connected suction source (such as a pump or syringe) that may move and hold the clot to the tissue-engaging section 108 while the pump assembly breaks and ingests the clot. For example, a suction syringe may be connected to the outlet tube 132, the outlet tube 132 being fluidly connected to the suction inlet 1202 by a suction channel 1206. When vacuum pressure is applied via the syringe, fluid may flow through aspiration inlet 1202, which aspiration inlet 1202 may allow device 102 to draw material into the device or hold it there while tissue engaging portion 108 and the rest of pumping assembly 110 remove the clot. In this manner, suction inlet 1202 may be an integral part of tissue-engaging portion 108.

Likewise, the infusion port 1212 may be connected to a tube that allows a user to inject material into the distal end of the device 102 through the infusion channel 1208. For example, developer may be injected into the front of the device 102. Alternatively, a drug or any other clinically suitable material may be injected. In other embodiments, saline may be injected through the infusion outlet 1204. This may advantageously provide a low viscosity fluid for pumping assembly 110 to aid clot extraction and reduce blood loss. Alternatively, the infused saline may be used to pressurize the blood vessel so that the blood vessel does not collapse due to the negative pressure created by the pumping assembly 110 or a separate suction source. The infused saline may also be used to assist the tissue engagement portion 108 in uptake of material. Pumping assembly 110 may work better when the more viscous material is mixed with a viscous fluid such as water, saline, or blood. The infused fluid may also be ejected at high velocity to provide disruption of the more viscous material at the tissue engagement portion 108 and thereby improve uptake performance. In some embodiments, the infused fluid may include saline and glucose, which may be used to flush blood out of the vessel to improve clot visualization using techniques such as Optical Coherence Tomography (OCT).

An extrusion or tubing within the catheter body 104 may be used to fluidly connect the suction outlet 1210 and the infusion port 1212 to the handle assembly 106. In the illustrated embodiment, channels 1206 and 1208 are formed between the stator 114 and the distal sleeve 120 and are helically wound around the stator 114 to avoid the stator helical cavity 210. In other embodiments, the channels may be straight or in another non-helical pattern. In other embodiments, the two channels may be aspiration channels 1206 or infusion channels 1208, or the device 102 may have only one channel or more than two channels. In other embodiments, the channel may be used to insert a guidewire or other device useful in standard catheter procedures. For example, a guidewire may be inserted through one of the passages and used to deliver the device to a site within a patient lumen or cavity.

Fig. 13A-13B illustrate an alternative embodiment of a device 1300 according to the present disclosure. More specifically, and contrary to the previously illustrated embodiment, the apparatus 1300 is shown as a stator 114 having a uniform wall thickness. In fig. 13A, the distal end of the device 102 is shown, including two stator supports 1302. The catheter body 104 extends over the entire distal end of the device 102 and contains the stator support 1302 without the distal sleeve 120.

In fig. 13B, the apparatus 1300 of fig. 13A is shown in more detail in an exploded view. As shown, the stator 114 has a stator toroidal cavity 210 and slots 220 similar to those in the previous embodiments. However, in contrast to the previously discussed embodiments, the outer profile of the stator 114 is not a cylinder. Instead, the outer profile of the stator 114 matches the stator toroidal cavity 210 such that a substantially uniform wall thickness is maintained throughout the stator 114. The wall thickness may vary depending on the overall size of the catheter and the clinical use; however, in certain example embodiments, the wall thickness may be from about 0.1mm and include about 0.1mm to about 10mm and include about 10mm, from about 0.2mm and include about 0.2mm to about 1mm and include about 1mm, or about 0.4mm.

The stator support 1302 generally includes an inner surface that matches the outer contour of the stator 114. As the rotor 116 spins within the stator 114, the stator toroidal cavity 210 is compressed between the rotor helical section 214 and the stator support 1302. Since the stator 114 has a substantially uniform wall thickness, the compression and sealing performance can be maintained along the entire helical contact line. However, the present disclosure contemplates that other external contours of stator 114 are possible, and embodiments are contemplated, particularly where stator 114 may not have a uniform wall thickness.

The apparatus 1300 also includes a suction channel 1206 that extends over an outer surface of the stator support 1302. Such a configuration of the suction channels 1206 may be beneficial because they are present in the stator support 1302 and therefore do not affect the sealing of the stator 114. In some embodiments, the stator support 1302 material may be harder than the stator 114 material, for example, the stator support 1302 may be formed of hard plastic or metal, and the stator 114 may be formed of an elastomeric material. Alternatively, each of the stator supports 1302 may be formed of a resilient material (such as silicone or polyurethane) that is harder than the stator 114 material.

Stator support 1302 includes locating features 1304 for interacting with rotor hub 216. In the illustrated embodiment, the locating feature 1304 provides both distal and proximal locating elements 118 for the rotating hub 216. Such positioning features 1304 may be incorporated into any of the embodiments described herein. The embodiment of fig. 13B also includes an auger feature 1306 extending along the torque member 122. The auger feature 1306 may help, among other things, push fluid and material proximally within the catheter body 104 and reduce blockage of the lumen of the blocked catheter body 104. The auger feature 1306 may be a separate component surrounding the torque member 122 or may be integrally formed with the torque member 122.

Fig. 14A-14H illustrate several alternative embodiments of a tissue engaging portion 108 of a device according to the present disclosure. In fig. 14A, tissue-engaging portion 108 includes an extension feature 1402 that extends beyond the end of stator 114. The rotor distal tip 212 is thus concave, which may advantageously prevent damage to blood vessels, etc. The length of the extension feature 1402 may vary; however, in certain example embodiments, the extension feature 1402 may be from about 0.1mm and include about 0.1mm to about 100mm and include about 100mm, from about 1mm and include about 1mm to about 10mm and include about 10mm, or about 2mm. As shown, the extension feature 1402 may be formed by the distal sleeve 120. Alternatively, the extension feature 1402 may be formed from the catheter body 104 or may be a separate component coupled to the distal sleeve 120. Although illustrated as being substantially cylindrical, in other embodiments, the extension feature 1402 may end with a beveled end or be non-cylindrical. In other embodiments, the extension feature 1402 may be expandable and include a braid, laser cut component, or similar structure that forms a cage around the rotor distal tip 212 and the stator distal section 202 to provide a barrier against ingestion of blood vessels or other tissue into the pumping assembly 110. In other embodiments, the extension feature 1402 may be slidably or rotatably adjustable with respect to the pumping assembly 110. For example, an outer tube on the device 102 may be used to increase or decrease the amount by which the distal face of the stator 114 is recessed within the extension feature 1402. In still other embodiments, the pumping assembly 110 may be positioned anywhere along the length of the catheter body 104 such that the extension feature 1402 is merely a portion of the catheter body 104 that extends distally of the pumping assembly 110. For example, the pumping assembly 110 may be positioned partway within the catheter body 104 along the length of the catheter body 104.

Fig. 14B illustrates another embodiment of the device 102 that includes a funnel feature 1404 on the tissue-engaging section 108. Funnel feature 1404 may help, among other things, direct fluid and material into stator helical cavity 210, or may alternatively provide a suction cup feature for securing the material to tissue-engaging portion 108 during ingestion.

In fig. 14C, the rotor distal tip 212 includes a rotor tip extension 1406 that extends forward into the funnel feature 1402. The rotor tip extension 1406 may assist the tissue engaging portion 108 in breaking up and ingestion of material into the stator 114. The rotor tip extension 1406 may have a pointed geometry as shown, or may be of many other shapes and configurations, such as an auger shape or a paddle shape. In some embodiments, the rotor tip extension 1406 may remain within the extension feature 1402 or may extend beyond the distal end of the device 102. In some embodiments, the rotor tip extension 1406 may be advanced or retracted by a user. For example, the rotor 116 may be advanced during certain portions of the operation to extend the rotor tip extension 1406 to help disrupt the clot and remove the wall-adhered clot. During this operation, the handle assembly 106 may rotate the rotor 116 at a slower speed to prevent vascular damage. The rotor 116 may then be retracted such that the rotor distal tip 212 is flush with the end of the stator 114 and the risk of vascular damage is minimized, which may allow for faster motor rotational speeds.

In fig. 14D, the rotor 116 has a helical lumen extending through the length of the rotor 116 that allows an extension wire 1408 or similar elongated structure to pass through the rotor 116. Extension wire 1408 can be advanced out of the end of rotor 116 to form an advanceable rotor tip extension 1406 in tissue engaging portion 108. Extension line 1408 may include a predetermined shape, such as a curve or a hook, configured to contact the vessel wall and disrupt the clot. The motor speed of the handle assembly 106 may be controlled depending on whether the extension line 1408 is extended. In some embodiments, the extension wire 1408 is non-adjustable and is an integral part of the rotor 116. Alternatively, the extension wire 1408 may be used as a guidewire for navigating and delivering the device 102 to a target site.

In fig. 14E, distal sleeve 120 includes a capped end 1410, which capped end 1410 may advantageously prevent tissue engaging portion 108 from ingesting vessel walls, valves, or other tissue that is not intended to be removed by device 102. Distal sleeve 120 further includes a side cutout 1412, which side cutout 1412 may guide material laterally into tissue-engaging portion 108. This may be particularly useful for materials present on the lumen wall of a blood vessel. In this embodiment, the side notch 1412 may be rotated circumferentially using a mechanism such as the catheter hub 124.

In fig. 14F, the tissue-engaging portion 108 includes a series of thrombus abutments (e.g., abutment 1414) that protrude from the distal end of the stator 114. The gaps between adjacent thrombus seats may form one or more fluid inlets (e.g., fluid inlet 1416). The fluid inlet may allow a low viscosity fluid (e.g., blood) to still enter the pumping assembly 110 while the more viscous material is ingested. This may advantageously enable the pumping assembly 110 to ingest a mixture of blood and thrombus, rather than just thrombus, which may improve the performance of the pumping assembly 110.

In fig. 14G, the tissue-engaging section 108 includes an infusion outlet 1204 in the stator 114. The infusion outlet 1204 may be used to inject a fluid (e.g., saline), which may provide improved performance of the pumping assembly 110. The injected fluid may ensure that pumping assembly 110 has an optimal mixture of low viscosity material and high viscosity material. In addition, the infusion outlet 1204 may be directed at an angle and used to spray viscous material at high speeds. This may advantageously break up viscous materials such as thrombus prior to ingestion by the pumping assembly 110. The infusion outlet 1204 may be directed at an angle or perpendicular to the end of the stator 114.

In fig. 14H, the tissue-engaging section 108 includes an infusion outlet 1206 through the rotor 116. For example, the rotor 116 may have a lumen extending through its center and connected to a hollow torque member, such as a tube or torque coil. The injected fluid may contribute to the performance of the pumping assembly 110. Alternatively, the injected fluid may include contrast media, a fluid with an Active Pharmaceutical Ingredient (API), or many other desired fluids.

Any combination of features or elements in the foregoing embodiments can be used alone or in combination with other embodiments discussed herein. For example, the rotor tip extension 1406 may be present within the capped end 1410 such that it breaks the clot prior to ingestion in the pumping assembly 110, but with limited risk of vascular injury due to the inclusion of the rotor tip extension 1406 within the distal sleeve 120.

Fig. 15A and 15B illustrate an embodiment of the device 102 that includes a guidewire 1502. Generally, the device 102 is delivered through the vasculature of a patient to the material to be removed. Some catheterization techniques involve advancing a device over a guidewire or smaller catheter. In the illustrated embodiment of fig. 15A and 15B, the guidewire 1502 is inserted through the access aperture 1504 near the distal bend 206 of the distal sleeve 120. The access aperture 1504 is generally sized to receive any suitable guidewire or microcatheter; however, in at least some embodiments, the access aperture 1504 can have a diameter of from about 0.008 inches and including about 0.008 inches to about 0.080 inches and including about 0.080 inches or about 0.035 inches. This advantageously allows the guidewire 1502 to be navigated and placed in the correct location within the patient's vasculature, and then the device 102 can be advanced over the guidewire 1502 to the target site. With distal bend 206, pumping assembly 110 is offset from the axis of catheter body 104 and guidewire 1502 such that the lumen of pumping assembly 110 does not need to clear guidewire 1502 in order for device 102 to travel along guidewire 1502. In some embodiments, additional exit holes may be present on the catheter body 104 or distal sleeve 120, which allow for quick replacement of the catheter. Once the guidewire 1502 is in place, the proximal end of the guidewire 1502 may be fed through the inlet aperture 1504 and then out of the outlet aperture in the catheter body 104. In this way, the guidewire 1502 need not be excessively long.

The present disclosure contemplates other methods of navigating the device 102 over the guidewire 1502. In some embodiments, the rotor 116 may be removed from the stator 114 such that the guidewire 1502 may pass through the lumen created by the stator helical lumen 210. Once at the target site, the guidewire 1502 may be removed and the rotor 116 may be inserted into the stator 114. In other embodiments, the rotor 116 and/or torque member 122 may include a hollow lumen through the center thereof that may allow passage of a guidewire. In such embodiments, the proximal end of the guidewire 1502 may be inserted through the rotor 116 and torque member 122 to enable navigation of the device 102, and then the guidewire 1502 may be removed. In other embodiments, the guidewire 1502 may be reinstalled into the channel 1206 such that the device 102 travels along the guidewire 1502, the guidewire 1502 being helically wound around the stator 114 within the distal sleeve 120.

In fig. 15C, an embodiment of the device 102 having a plurality of distal bends 206 is shown. The plurality of distal bends 206 allow the axis of the stator 114 to remain relatively parallel to the axis of the catheter body 104 but offset such that rotation of the catheter body 104 moves the tissue-engaging section 108 within the blood vessel. Such embodiments may enable improved reach of the device 102 within large vessels without adversely directing the tissue engaging portion 108 toward the vessel wall. Any number of other suitable bends and orientations of the stator 114 relative to the catheter body 104 are contemplated.

In fig. 16A-16C, an embodiment of the device 102 is shown with a visualization assembly 1602 at the distal end of the stator 114. The stator opening 1606 may hold and/or orient the visualization assembly 1602 to face forward and may be offset from the stator helical cavity 210 such that the increased catheter size of the device 102 with the visualization assembly 1602 is minimized. In addition, the visualization cable 1604 may be primarily straight as it travels along the length of the stator 114. In some embodiments, the visualization assembly 1602 may be advanced or rotated forward and backward relative to the stator 114 to change the viewing angle. The visualization component 1602 may be a camera, such as a CMOS or CCD imaging device, that provides visual feedback to the user regarding tissue structure at the distal end of the device 102 or regarding the clot 602 in the blood vessel 604. Alternatively, the visualization component 1602 may be an intravascular ultrasound (IVUS) imaging probe or catheter. Alternatively, the visualization component 1602 may be an Optical Coherence Tomography (OCT) element. For example, the OCT element may be a guidewire that may be advanced from the end of the device 102. The head of the visualization assembly 1602 may have a diameter from about 0.25mm and including from about 0.25mm to about 3.0mm and including about 3.0mm, from about 0.5mm and including from about 0.5mm to about 2.0mm and including about 2.0mm or about 1.0 mm. Alternatively, the head of the visualization component 1602 may be rectangular in outline.

The head of the visualization assembly 1602 may be connected to a visualization cable 1604 that extends inside the catheter body 104 and outside the patient. The visualization component 1602 may include a display, such as an LCD or LED screen, to provide visual feedback to the user. In some embodiments, the user may view the display and advance or rotate the device 102 accordingly such that the distal end of the catheter is directed toward the desired tissue, such as a clot. The visual feedback may help the user navigate the end of the device away from or avoid activating the device 102 in the vicinity of the vessel wall, venous valve, or other vital tissue structure. In addition, visual feedback may indicate to the user when the blood vessel has collapsed due to negative pressure or excessive aspiration flow generated by the device 102.

In some implementations, the information provided by the visualization component 1602 can be used by or executed by software within a computing device in communication with the device 102. For example, if the software detects that the distal end of the device 102 is too close to a tissue structure such as a vessel wall or a venous valve, the software may disable the device 102. In other implementations, the software may create an alert or alarm to the user in such a case. In some embodiments, the software may assist the user in navigating to the material by providing an audible or visual indication. In other embodiments, aspects of the device 102 may be automatically controlled by, for example, the orientation of the distal end, advancement of the distal end in the blood vessel, and activation of the pumping assembly 110. In this way, the visualization component 1602 can implement more automated aspects of the program by providing feedback to the software. In some embodiments, the visualization component 1602 can provide feedback to the user regarding the location of the clot 602 within the blood vessel 604. For example, if the user moves the device 102 through the blood vessel 604, some of the clot 602 may be removed, but some of the clot 602 may remain, particularly a wall-adhered clot 602. The visualization component 1602 can indicate to the user where to guide the tissue-engaging portion 108 of the device and thereby provide more targeted clot 602 removal. In some embodiments, the visualization assembly 1602 may be advanced through the vessel 604 and then withdrawn, and a 2D or 3D representation of the vessel 604 may be displayed to the user. In some embodiments, the visualization assembly 1602 is not at the distal-most end of the device 102, but along the side of the pumping assembly 110 or within the catheter body 104.

In fig. 17A-17C, an embodiment of the apparatus 102 is shown having a first visualization component 1602 and a second visualization component 1608 helically wound around the stator 114. By wrapping the first visualization cable 1604 and the second visualization cable 1610 around the stator 114, the overall dimensional profile of the device 102 is not increased or minimally increased. In some implementations, the first visualization component 1602 is a camera and the second visualization component 1608 is an IVUS probe. In other embodiments, both components may be cameras and provide stereoscopic vision. In other embodiments, the visualization component may be directed at different angles or provide different depths of focus. The second visualization component 1608 need not be an imaging element. It may also be a light source for the first visualization component 1602 or for external visualization through the skin of the patient to enable direct visualization of the device 102. In other embodiments, the second visualization component 1608 may be a tube for delivering a material that facilitates visualization to the distal end of the device. For example, the second visualization component 1608 may deliver saline or other light transmissive fluid that is transparent to the first visualization component 1602 and may provide positive pressure within the blood vessel that maintains patency of the blood vessel and prevents collapse. In other embodiments, visualization component 1602 need not necessarily visualize cable 1604, and may include communication electronics for transmitting information to a display or device 102 using Wi-Fi, bluetooth, or any other suitable method.

In fig. 18A-18E, an embodiment of the device 102 with a suction catheter 1802 is shown. Inside the blood vessel 604 is a suction catheter 1802, the blood vessel 604 having material to be removed, in this case a clot 602 that blocks blood flow.

In fig. 18B, aspiration catheter 1802 is advanced to clot 602 and an aspiration source is connected to the catheter that engages clot 602. As shown, clot 602 has a plugged portion 1804 within aspiration catheter 1802. In this configuration, the vacuum level may be intentionally reduced to prevent ingestion of clot 602. Alternatively, the situation illustrated in fig. 18B may be caused by the maximum vacuum level of aspiration catheter 1802 not being sufficient to completely ingest clot 602.

In fig. 18C, a version of the device 102 is inserted through the lumen of the aspiration catheter 1802 and advanced to the clot 602 to facilitate further uptake of the clot 602. As described throughout this disclosure, the device 102 may be disposed against or proximal to the clot 602, and then activated to ingest the clot 602 into the device 102, for example, using one or both of mechanical engagement with the clot 602 and aspiration. For example, in fig. 18D, clot 602 has been partially ingested into device 102, and in fig. 18E, clot 602 has been completely removed from blood vessel 604.

In some embodiments, the device 102 may be a suction source for the suction catheter 1802, and a vacuum level may be created to engage the clot 602 onto the tip of the suction catheter 1804. In such embodiments, the pumping assembly 110 may be disposed within the aspiration catheter 1802 at a distance from about 0cm and including about 0cm to about 100cm, including about 100cm, or from about 0.1cm and including about 0.1cm to about 20cm, including about 20cm or about 0.5cm, away from the distal end. When the device 102 is activated, suction is created within the suction catheter 1802 that pulls the clot 602 into the suction catheter 1802 and up to the tissue engagement section 108. The clot 602 is then ingested into the pumping assembly 110 and expelled into the lumen of the catheter body 104 or the lumen of the aspiration catheter 1802. The position of the pumping assembly 110 may be adjusted as desired and, in some embodiments, may be advanced beyond the end of the suction catheter 1802. In this way, the user may adjust the position of the tissue engaging portion 108 based on the type of clot, the stage of the procedure, or any other reason. In some embodiments, the aspiration catheter 1802 may be a close fit to the outer diameter of the device 102 such that the catheter forms a slidable outer tube over the device 102 that may engage the clot 602 and may also push the clot away from the end of the device 102 to prevent or remove clogging of the pumping assembly 110. In other embodiments, the outer diameter of the device 102 may be smaller than the inner lumen of the aspiration catheter 1802, such that fluid may bypass the lumen of the device 102. In some embodiments, catheter body 104 is replaced with a control line that can advance, retract, or rotate pumping assembly 110. Thus, the lumen of the aspiration catheter 1802 may be maximized along its length and the delivery capability of the device 102 through the aspiration catheter 1802 may be improved.

In fig. 19A-19C, an embodiment of an apparatus 102 including a filter assembly is shown. In fig. 19A, an alternative embodiment of a handle assembly 106 having a catheter hub 124, a throttle valve 418, and two handle shells 126A, 126B is shown. The outlet tube 132 is connected to the collection assembly 112 having a filter assembly 712 and a collection cap 1902.

In fig. 19B, the same device 102 is shown with the collection assembly 112 in an exploded state. During operation, material removed using the apparatus 102 enters the collection assembly 112 and is then filtered by the filter assembly 712. By doing so, solid or semi-solid material (e.g., thrombogenic material) remains in the front region of the collection chamber, and lower viscosity material travels to and is separated into the rear region of the collection assembly 112. In some implementations, the collection assembly 112 may be at least partially transparent to provide a visual indication of the operation of the device 102 and the corresponding capture of material within the collection assembly 112. In some embodiments, the collection cap 1902 may also include a separate port for infusion that allows a user to inject a fluid (e.g., saline) so that material in the front region of the collection assembly 112 may be better visualized. In addition, the filtered blood may be stored for reintroduction into the patient as necessary. In some embodiments, the collection assembly 112 may be integral with the handle assembly 106 such that the outlet tube 134 may be omitted.

In fig. 19C, the device 102 includes a series of filters for separating solid or semi-solid materials from blood or other fluids and a return tube 716 for reintroducing the fluids into the patient. In one embodiment, the first filter assembly 712 can have a pore size of from about 25 μm and including from about 25 μm to about 1000 μm and including about 1000 μm, from about 100 μm and including from about 100 μm to about 400 μm and including about 400 μm or about 200 μm. In the same embodiment, the second filter assembly 1904 may have a pore size of from about 5 μm and including about 5 μm to about 100 μm and including about 100 μm or about 40 μm. More generally, however, any number of additional filters and filter pore sizes may be implemented. In addition, the return tube 716 may feed blood back to the patient through any number of access points (such as an introducer sheath, a separate access site) or through the catheter body 104.

In fig. 20, the device 102 is shown with the wall adherent material 2002 removed. In certain disease states, the material adheres to the walls of the blood vessel 604. The material may include certain thrombotic diseases such as DVT, and may also include plaque found in peripheral arterial disease and coronary artery disease. The wall adherent material 2002 may be difficult to remove with the straight catheter body 104. In this embodiment, the catheter body 104 includes a distal bend 206 and may be positioned using rotation 2004 of the catheter body 104. Such a device 102 may advantageously approximate the entire circumference of the blood vessel 604.

Alternatively or in addition to the proximal filtration and separation system previously discussed, the device 102 may also include a catheter filter 2006 along the catheter body 104. The catheter filter 2006 may include a series of holes in the catheter body 104, as shown, or may alternatively include a separate filter material. As blood and material are expelled from the pumping assembly 110 and pushed through the catheter body 104, the blood may be filtered from the material and may re-enter the blood vessel 604 by the filtered blood return 2008. This may advantageously reduce the amount of blood removed. The catheter filter 2006 may include a variety of pore sizes and lengths.

In fig. 21, an alternative embodiment of the device 102 is illustrated in which the tissue-engaging element 108 comprises an expandable funnel 2010. The expandable funnel 2010 may collapse in the delivery sheath during introduction into the blood vessel 604. Once deployed, the expandable funnel 2010 may be opened in the blood vessel 604 and provide a partial or complete flow block in the blood vessel 604. This may advantageously help tissue-engaging element 108 pull material toward pumping assembly 110 and may reduce the likelihood of particles flowing downstream of the treatment site. In certain embodiments, the expandable funnel 2010 may be constructed of braided wire or laser cut tubing and may additionally include a membrane such as silicone or PTFE that makes the expandable funnel 2010 impermeable or semi-impermeable.

Fig. 22 illustrates an alternative embodiment of the apparatus 102, wherein the pumping assembly 110 is disposed within the handle assembly 106. More specifically, the illustrated pumping assembly 110 is a progressive cavity pump that includes a stator 114 and a rotor 116, and the operation of which is described herein. The handle assembly 106 has a motor 416, the motor 416 is rotationally coupled to the motor adapter 412, and the motor adapter 412 is then rotationally coupled to the rotor 116. The manifold 128 fluidly connects the inlet of the pumping assembly 110 to the catheter body 104 such that operation of the pumping assembly 110 draws fluid from the catheter body 104. The distal tip of the catheter body 104 may be open and thus function like a conventional aspiration catheter. Advantageously, such an embodiment may not require a separate piece of equipment and create a vacuum closer to the end of the catheter, resulting in less line loss and greater dynamic control by the user. In the illustrated embodiment, the outlet tube 132 empties the fluid into a waste container, and the cable 134 provides power to the device 102. In other embodiments, the waste container may be integrated with the battery into the handle assembly 106 such that no additional cables or lines extend from the device 102. In some embodiments, the distal tip of catheter body 104 may still include additional pumping assemblies 110 as described in other embodiments. The two pumping assemblies 110 may be rotationally connected via a torque member 122 or may be independently rotatable. In other embodiments, the distal tip of the catheter body 104 may include other morcellating or tissue disrupting elements, such as a screw, auger, or morcellator. Other types of pumps in the handle assembly 106 are contemplated, such as piston pumps, diaphragm pumps, peristaltic pumps, centrifugal pumps, screw pumps, rotary gear pumps, or any other suitable pumping mechanism.

The following is a discussion of various alternative or complementary features that may be included in embodiments of the present disclosure. Unless specifically indicated, it should be assumed that any of the alternatives discussed in the following sections may be combined with or applied to any of the embodiments included in the disclosure or otherwise encompassed by the scope thereof.

In some embodiments, the rotor 116 may have various coatings or textures along its rotor helical section 214. The coating may be a lubricious coating such as a hydrophilic or hydrophobic coating or a metallic plating. Alternatively, the outer surface may be textured or coated to provide additional friction to pull the clot into the stator 114. In other embodiments, the rotor helical section 214 may include an elastomeric coating on its outer surface such that it becomes a sealing member, and the stator 114 may therefore be constructed of a harder material (e.g., thermoplastic or metal) that is less compressible. In such embodiments, sealing is achieved primarily by compressing a portion of the rotor 116 rather than the stator 114. In other embodiments, neither the rotor 116 nor the stator 114 is an elastomeric material, and no seal is achieved during operation of the apparatus. For example, there may be a gap between the rotor 116 and the stator 114 that creates an unsealed cavity, but when the rotor 116 spins, the pumping assembly 110 still behaves like a pump, but includes some slippage due to the gap. Slip can advantageously prevent efficient evacuation of low viscosity fluids (e.g., blood), but still enable pumping of relatively viscous materials such as clots. This may advantageously reduce blood loss during clot extraction. Such clearance gaps are sometimes implemented in progressive cavity pumps to allow for manufacturing tolerances of the components.

In some embodiments, the stator 114 has a rounded or tapered distal edge rather than a sharp distal edge as shown in many of the figures. The rounded distal edge may prevent vascular damage by providing a smoother surface to contact the vascular wall.

In some embodiments, pumping assembly 110 does not pump fluid. For example, the stator helical portion 210 or the rotor helical section 214 may be composed of only a portion (such as one half) of a full pitch cavity. In such an embodiment, a fully closed cavity 224 is not achieved between the stator helical cavity 210 and the rotor helical section 214, as there will be a section where the lumen of the catheter body 104 is fluidly connected to the rotor 116 rotation of the fluid at the distal end of the device 102. A separate suction source may be applied to the device 102, for example, through the outlet tube 132, to draw fluid and material into the catheter body 104. The rotor 116 may then be rotated to help ingest material that may otherwise have been jammed. In this manner, the tissue engaging section 108, including the self-rotating sub 116, works in conjunction with a separate suction source, which may include a pump, to remove fluids and materials. The suction source may be a pump within the handle assembly 106, such as a piston pump, peristaltic pump, or any other type of pump. The rotor 116 assists in the suction power by breaking up the clot and pushing fragments of the clot into the catheter body 104. In some embodiments, the device 102 may not include the stator 114 and the rotor 116 may instead spin within the catheter body 104.

In some implementations, the device 102 may include more than one pumping assembly 110. For example, the catheter body 104 may have one or more pumping assemblies 110 along its length that further assist in removing material from the patient or prevent the catheter body 104 from becoming occluded. Multiple pumping assemblies 110 may be rotationally connected like a daisy chain by one or more torque members 122. In other embodiments, pumping assembly 110 may rotate at different speeds and timings. The pumping assemblies 110 may all have the same pumping parameters such as pitch and diameter, or may be unique. In some embodiments, the entire length of the catheter body 104 may have a single or multiple pumping assemblies 110. Further, a plurality of inlet or outlet apertures may be present on the catheter body 104. Some pumping assemblies 110 may be positioned within the patient's body while other pumping assemblies may be positioned outside the patient's body during their intended use.

In some embodiments, the distal bend 206 may be configured in various ways. In some embodiments, the distal bend may be a rigid angle, while in other configurations, the distal bend may be flexible and deformable by tissue structure or by a user prior to manipulation. In other embodiments, the distal bend 206 may be steerable. For example, the handle assembly 106 may include an interface that allows a user to actively adjust the angle of the distal bend 206. This may be achieved by a control line or any other suitable mechanism. In some embodiments, rotation of the catheter hub 124 and the catheter body 104 may be accomplished automatically by the handle assembly 106. For example, a separate motor may drive rotation of the catheter hub 124 at a desired speed or relative to the main motor 416 driving the pump assembly. In other embodiments, rotation of the catheter hub 124 may be driven by the motor 416, possibly through a gear reduction that spins the tip of the device once for a given number of rotor 116 revolutions. The user may be able to provide inputs and controls for motorized rotation of the catheter hub 124. The spinning of the catheter hub 124 may help ensure that the distal bend 206 guides the tissue engaging portion 108 around the lumen of the blood vessel 604.

In some embodiments, the controller 136 may apply different rotation profiles (rotation profiles) to the drive system 130 and the motor 416. For example, in one embodiment of the rotation profile, the motor speed is proportional to the throttle 418 user input. When the user further depresses the throttle 418, the motor 416 spins faster. In other embodiments of the rotation profile, the throttle 418 may be switched between certain discrete motor 416 speeds. For example, a low motor 416 speed may be used to ingest low flow of blood and acute soft clot 602. Feedback may then be provided to the user indicating that a more viscous clot 602 is encountered, and thus the user may further depress the throttle 418 to achieve a higher discrete speed optimized for clot 602 uptake, as described elsewhere. In other embodiments of the rotating profile, the controller 136 may include additional profiles, such as pulsed rotation, in which the pump rotates at high speed for discrete amounts of time with pauses therebetween. For example, the controller 136 may be configured to spin the motor 416 a first discrete number of revolutions at a first speed and then a second discrete number of revolutions at a second discrete speed, or alternatively may be configured to stop rotating for a discrete amount of time. The controller 136 may repeatedly perform this mode. In other embodiments of the rotating profile, the controller 136 motor profile may include a high speed pumping cycle with short rotating bursts in opposite directions that expel small amounts of fluid. These profiles may improve clot destruction and uptake when mixing clot and blood. In some embodiments, the pulse profile may create a pulsed vacuum at the distal end of the catheter, which may aid in the uptake of the clot. In some embodiments of the rotation profile, a user may provide input to the controller 416 and adjust the rotation profile. Many motor rotation profiles are contemplated.

In some embodiments, handle assembly 106 may be divided into a disposable assembly and a reusable assembly. For example, the catheter body 104 and the catheter hub 124, as well as all distal elements and the collection assembly 112, may be disposable, while a majority of the handle assembly 106 may be a durable assembly. In this manner, a user may connect the disposable portion and the reusable portion, perform an operation, and then dispose of the catheter assembly while cleaning and reusing the handle assembly 106. Many other configurations are contemplated.

In some embodiments, the controller 136 may adjust the speed of the motor 416 based on the torque required to turn the rotor 116. For example, when the pump assembly 110 ingests fluid, it will likely require a lower torque to rotate than when the tissue engaging portion 108 is ingesting viscous material such as a clot. One estimate of the torque applied is the current that motor 416 uses to turn at a given speed. The controller 136 may define different profiles based on the motor 416 current, wherein the profiles provide a relationship between torque and rotational speed. Accordingly, the controller 136 may adjust the rotational speed of the rotor 116 based on the profile as the torque applied by the motor 416 varies.

For example, if the motor 416 only ingests blood, it may rotate at a slower speed and thus reduce blood loss. In some embodiments, the baseline torque may be set individually for each device by rotating the motor in air, water, saline, or blood. For example, the baseline torque may be saved in the controller 136 at the time of manufacture, or alternatively may be established during an initialization or priming step performed by the user. Thus, the baseline may be used to determine whether the pump assembly 110 is ingesting a clot or engaging other vascular structures. The motor 416 speed may be adjusted accordingly. In other embodiments, the baseline may be dynamically established by the controller based on a sampling of previously recorded measurements (such as motor current). Other methods of measuring the torque required to turn the rotor are contemplated, such as motor voltages, torque meters, or any other suitable feedback. Once the tissue engaging section 108 begins engaging and ingesting the clot, the motor 416 current increases and the controller 136 can increase the speed of the motor 416 to more efficiently ingest the clot. For example, the baseline torque that may be established prior to starting the procedure may be from about 0.1 mN.m and include about 0.1 mN.m to about 200 mN.m and include about 200 mN.m or about 10 mN.m. The controller 136 may then determine that the clot is engaged and change the speed of the motor 416 if the torque increases from about 5% and including about 5% to about 80% and including about 80% or about 20%. Many profiles in various states are contemplated. In another embodiment, the same method may be used to determine whether a blood vessel or other delicate structure is engaged with the tissue engagement portion 108, and the controller 136 may completely stop or even reverse the drive system 130. Feedback may be provided to the user in a number of ways. For example, the audible tone may be adjusted in volume or frequency and alert the user whether the pump assembly 110 is ingesting blood and the tissue engaging section 108 is encountering a clot. Many different user interfaces may be used, such as light, sound, or vibration.

In some implementations, the device 102 may be connected to a user interface, such as a smart phone, tablet, computer, or controller box. The connection with the device 102 may be made using bluetooth, wi-Fi, zigbee, wired connection, or any other suitable method. The user may adjust the controller 136 via the user interface and thereby change the manner in which the device 102 responds to different inputs, such as the throttle 418. In some implementations, the device 102 may be controlled by other user inputs. For example, a foot pedal may be used as the throttle 418 instead of the trigger.

In some implementations, the device 102 may record data from a given program and store the data in the controller 136 or transmit the data to a separate recording device via a wireless or wired connection. The data may include information such as the volume of blood removed, a torque profile indicating clot engagement, a length of use, or any other information generated during the procedure. The user may view the data or store it for future reference.

In some embodiments, filter assembly 712 may be located within handle assembly 106. In such embodiments, blood exiting the manifold 128 may be fed directly into a filter assembly 712 within the handle assembly 106, which filter assembly 712 separates clot material from the blood. The return tube 716 may feed filtered blood through the catheter body 104 and out of the side hole. In this way, the device 102 may not require an external tube, which may simplify setup and operation. The filtered clot may be contained within a collection assembly 112 within the handle assembly 106. In some embodiments, the catheter body 104 may include a plurality of fenestrations proximal to the pumping assembly 110 that allow blood to return to the patient, but filter and retain clots within the catheter body 104. In this embodiment, the catheter body 104 itself or components within the catheter body 104 may act as the filter assembly 712.

In some embodiments, the pump assembly may operate in reverse to that described in fig. 3A-3F to dispense material out of the pumping assembly 110. For example, if the pumping assembly 110 or tissue engagement portion 108 becomes jammed, the controller 136 may rotate the drive system 130 counterclockwise and thus dispense material out of the pumping assembly 110. This may advantageously unblock pumping assembly 110 and allow a user to resume removal of material. In some embodiments, this may be done at regular intervals of run time or at the end of a pumping operation to automatically unblock the device without user input. In other embodiments, reversal of pumping assembly 110 may be used to release blood vessels or valves or other tissue that are not intended to be engaged by tissue engaging portion 108.

In some embodiments, the stiffness of the stator 114 material may be selected based on the material to be removed. For example, when removing an acute fresh clot, the user may select the device 102 with the stator 114 composed of a more resilient material (such as shore 35A silicone). When removing a relatively viscous chronic clot, the user may select a device 102 having a stator 114 constructed of nylon or a similarly rigid plastic.

In some embodiments, the device 102 may be pre-filled with fluid prior to use. For example, the user may place the tip of the device 102 into a container of saline and activate the device 102 to pump saline into the catheter body 104. Alternatively, the user may pre-prime the pumping assembly 110 with grease or lubricant prior to clinical use.

Experimental results

Prototype devices were constructed according to the embodiment and design shown in fig. 1A. The stator 114 is constructed of an elastomeric shore 80A material, and the other materials are 3D printed in hard plastic. The catheter body 104 is HDPE extrudate and a 24 volt brushless DC motor 416 is used in the drive system 130. Tests were performed to assess the ability to extract clots from the simulated blood vessels. An artificial clot simulator weighing 6.3gm was placed between two light-transmitting plates, which included cylindrical cutouts. The model was pressurized with brine from a gravity feed reservoir at a height of about 12 cm. The device 102 is inserted through the hemostatic valve and into the mold. The pumping assembly 110 is activated by the throttle 418 and the motor 416. As the rotor 116 rotates, fluid is pumped through the device and out the outlet tube. The tissue engaging section 108 is then advanced toward the clot simulator. Tissue engaging section 108 and pumping assembly 110 efficiently removed the clot simulant within 19 seconds and the measurement volume of the expelled fluid was only 52mL. Experimental results demonstrate that this embodiment of the device 102 works as expected.

A number of descriptions have been given of thrombectomy procedures in which clots and thrombus are removed, but this is not intended to limit the scope or use of the device 102 to such procedures. For the avoidance of doubt, the terms clot and thrombus may be considered interchangeable with any material being removed. The device 102 may have a variety of shapes and sizes for use as a platform for any type of thrombectomy, embolectomy, or foreign body, stone, or tissue removal in any portion of the body or vessel. This may include, but is not limited to, cerebral thrombosis resulting in ischemic stroke, acute and chronic deep vein thrombosis, pulmonary embolism, dural sinus thrombosis, controlled aspiration of tissue and/or fluids during surgery of the ventricular system or brain, removal of liquid embolic agents, coagulated hemodialysis grafts, peripheral arterial thromboembolism (including mesentery and peripheral vascular tree), peripheral arterial occlusion, critical Limb Ischemia (CLI), chronic Total Occlusion (CTO), and stone removal. The device 102 may also be used in an debulking procedure for removing tumors and other cancerous material.

Many other suitable applications may use such devices 102 to remove tissue, foreign objects, stones or other objects within a tubular receiving space or even within a non-tubular or non-receiving space. In some embodiments, the device 102 may be used to remove tissue during a small port laparoscopic procedure, including biopsy or to remove malignant tissue.

The names and labels applied to the various components and parts should not be considered as limiting the scope of the apparatus and methods of the present invention.

Although various method and apparatus embodiments have been described in detail herein with reference to certain versions, it is to be understood that other versions, embodiments, methods of use, and combinations thereof are possible. Therefore, the spirit and scope of the appended claims should not be limited to the description of the embodiments contained herein.

Illustrative aspects of the disclosure

Illustrative examples of the present disclosure include, but are not limited to, the following:

Aspect 1: an apparatus, comprising: a catheter including a lumen extending therethrough; and a progressive cavity pump at the distal portion of the catheter, wherein the progressive cavity pump is in communication with each of the lumen and an external environment surrounding the distal portion of the catheter, and wherein the progressive cavity pump is operable to transfer material from the external environment into the lumen of the catheter.

Aspect 2: the apparatus of aspect 1, further comprising a container in fluid communication with the proximal end of the lumen, wherein the container is configured to provide or receive material transferred through the lumen.

Aspect 3: the apparatus of aspect 1, wherein the progressive cavity pump is coupled to and extends from a distal end of the catheter.

Aspect 4: the apparatus of aspect 1, wherein the progressive cavity pump is at least partially disposed within the lumen at the distal end of the catheter.

Aspect 5: the apparatus of aspect 1, wherein the progressive cavity pump includes a stator formed at least in part from an elastomeric material.

Aspect 6: the apparatus of aspect 1, wherein the progressive cavity pump includes each of a stator defining a helical stator lumen and a helical rotor extending through the helical stator lumen, and wherein a pitch of the helical stator lumen is about twice a pitch of the helical rotor.

Aspect 7: the apparatus of aspect 1, wherein the progressive cavity pump comprises a stator and a rotor arranged to form a cavity between the stator and the rotor, and wherein the cavity is fluid-tight due to compression between the stator and the rotor.

Aspect 8: the apparatus of aspect 1, wherein the progressive cavity pump comprises a stator and a rotor arranged to form a cavity between the stator and the rotor, and wherein the cavity is unsealed due to a clearance gap between the stator and the rotor.

Aspect 9: the apparatus of aspect 1, wherein the progressive cavity pump includes a rotor, the apparatus further comprising a torque member extending through the lumen and coupled to the rotor, the torque member being operable to transmit torque applied to a proximal end of the torque member to the rotor.

Aspect 10: the apparatus of aspect 1, wherein the progressive cavity pump includes a rotor, the apparatus further comprising a motor coupled to the rotor and operable to drive the rotor.

Aspect 11: the apparatus of aspect 1, wherein the distal end of the catheter comprises an angled tip.

Aspect 12: the device of aspect 1, wherein the distal portion has an outer diameter of from about 6 french and including about 6 french to about 20 french and including about 20 french.

Aspect 13: the apparatus of aspect 1, wherein the progressive cavity pump forms a seal between the lumen and the external environment.

Aspect 14: the apparatus of aspect 1, further comprising a handle assembly coupled to the proximal end of the catheter, wherein the handle assembly comprises a drive system for controlling the progressive cavity pump.

Aspect 15: the apparatus of aspect 1, further comprising a distal pumping assembly coupled to the distal end of the catheter and comprising a progressive cavity pump, wherein the distal pumping assembly comprises a sleeve coupled to and rotationally fixed relative to a stator of the progressive cavity pump.

Aspect 16: the apparatus of aspect 1, further comprising a distal pumping assembly disposed within the distal end of the catheter and comprising a progressive cavity pump.

Aspect 17: the apparatus of aspect 1, further comprising a distal pumping assembly coupled to the distal end of the catheter and comprising a progressive cavity pump, wherein the progressive cavity pump comprises each of a stator and a rotor, the distal pumping assembly comprises a positioning element disposed at the proximal end of the stator, and the positioning element is configured to maintain an axial relationship between the stator and the rotor during operation of the distal pumping assembly.

Aspect 18: the apparatus of aspect 1, wherein the progressive cavity pump includes a rotor coupled to a drive system configured to rotate the rotor at a plurality of rotational speeds.

Aspect 19: the apparatus of aspect 18, wherein the drive system is configured to change between ones of the plurality of rotational speeds in response to torque applied by the drive system.

Aspect 20: the apparatus of aspect 19, wherein the torque applied by the drive system is estimated based on a current drawn by a motor of the drive system.

Aspect 21: the apparatus of claim 19, wherein the drive system includes a profile defining one or more relationships between torque and rotational speed, and wherein the drive system is configured to vary between speeds of the plurality of rotational speeds based on the profile in response to the torque.

Aspect 22: the apparatus of aspect 1, further comprising a collection assembly in communication with the lumen of the catheter, the collection assembly configured to receive material ingested by the progressive cavity pump, wherein the collection assembly comprises a filtration system.

Aspect 23: the apparatus of aspect 22, further comprising a return tube in communication with the collection assembly, the return tube configured to receive material not retained by the filter.

Aspect 24: the apparatus of aspect 1, wherein the progressive cavity pump includes a stator defining a stator lumen and a stator opening separate from the stator lumen, the apparatus further comprising a visualization assembly supported within the stator opening.

Aspect 25: the apparatus of aspect 24, wherein the visualization assembly includes a cable and the stator defines a channel through which the cable extends.

Aspect 26: the apparatus of aspect 25, wherein the channel extends helically around the stator.

Aspect 27: the apparatus of aspect 1, wherein the progressive cavity pump includes a stator defining a stator lumen and a channel separate from the stator lumen.

Aspect 28: the apparatus of aspect 1, wherein the progressive cavity pump includes a stator defining a stator lumen and a channel separate from the stator lumen and extending along an outer surface of the stator.

Aspect 29: the apparatus of aspect 1, wherein the progressive cavity pump includes a stator defining a stator lumen and a channel separated from the stator lumen and extending helically along an outer surface of the stator.

Aspect 30: the apparatus of aspect 1, wherein the progressive cavity pump includes a stator defining a stator lumen and a plurality of channels separate from the stator lumen.

Aspect 31: the device of aspect 1, further comprising a port extending between an interior volume of the device and an external environment and positioned proximal to the progressive cavity pump.

Aspect 32: the apparatus of aspect 31, wherein the port is sized to receive at least one of a guidewire and a microcatheter.

Aspect 33: a method, comprising: positioning a material removal device within a physiological lumen or cavity of a patient, the material removal device comprising: a catheter including a catheter lumen extending therethrough; and a progressive cavity pump at a distal portion of the catheter, wherein the progressive cavity pump communicates with each of the catheter lumen and a physiological lumen or cavity of the patient; a progressive cavity pump is actuated to ingest material from a physiological lumen or cavity into a catheter lumen.

Aspect 34: the method of aspect 33, further comprising delivering the material through the catheter lumen to a container disposed outside the patient and in communication with the proximal end of the catheter lumen.

Aspect 35: the method of aspect 33, wherein the progressive cavity pump includes a stator and a rotor arranged to form a cavity therebetween, wherein actuating the progressive cavity pump ingests material into the cavity.

Aspect 35: the method of aspect 33, wherein the material removal apparatus is an apparatus according to any one of aspects 1 to 32.

Aspect 36: the method of aspect 33, wherein the material removal apparatus is the apparatus of aspect 18, and the method further comprises rotating the rotor at a first speed of the plurality of rotational speeds; obtaining torque applied to the rotor by the drive system while rotating the rotor at a first speed; and changing the rotational speed of the rotor to a second rotational speed of the plurality of rotational speeds in response to the torque.

Aspect 36: the method of aspect 33, wherein the material removal apparatus is the apparatus of aspect 19, and the method further comprises rotating the rotor at a first speed of the plurality of rotational speeds; obtaining torque applied to the rotor by the drive system while rotating the rotor at a first speed; and changing the rotational speed of the rotor to a second rotational speed of the plurality of rotational speeds in response to the torque and in accordance with the profile.

Aspect 37: the method of aspect 33, further comprising transferring the material to a collection assembly in communication with the catheter lumen and external to the patient.

Aspect 38: the method of aspect 37, further comprising filtering the ingested material using a filter assembly disposed within or in line with the collection assembly.

Aspect 39: the method of aspect 37, further comprising returning at least a portion of the ingested material to the patient via a return tube in communication with the collection assembly.

Aspect 40: the method of aspect 33, wherein the progressive cavity pump includes a stator defining a stator lumen and a channel separate from the stator lumen, the method further comprising at least one of infusing a substance through the channel or applying suction.

Aspect 41: the method of aspect 33, wherein positioning the material removal device comprises positioning the material removal device within a second catheter disposed within a physiological lumen or cavity of the patient.

Aspect 42: the method of aspect 41, wherein the material is disposed within a lumen of the second catheter, and ingesting the material from the physiological lumen or cavity into the catheter lumen comprises ingesting the material from within the lumen of the second catheter.

Aspect 43: the method of aspect 33, wherein positioning the material removal device comprises translating the material removal device along the guidewire.

Aspect 44: the method of aspect 43, wherein the material removal device is the device of aspect 31, and the guidewire extends through the port during translation of the material removal device along the guidewire.

Claims (20)

1. A device comprising: a catheter comprising a lumen extending through the catheter; and A progressive cavity pump at a distal portion of the catheter, wherein the progressive cavity pump is in communication with each of the lumen and an external environment surrounding the distal portion of the catheter, and wherein the progressive cavity pump is operable to transfer material from the external environment into the lumen of the catheter. 2. The apparatus of claim 1, further comprising a container in fluid communication with the proximal end of the lumen, wherein the container is configured to provide or receive material transferred through the lumen. 3. The apparatus of claim 1, wherein the progressive cavity pump is coupled to and extends from a distal end of the catheter. 4. The apparatus of claim 1, wherein the progressive cavity pump is disposed at least partially within the lumen at a distal end of the catheter. 5. The apparatus of claim 1, wherein the progressive cavity pump includes a stator formed at least in part from an elastomeric material. 6. The apparatus of claim 1 , wherein the progressive cavity pump comprises each of a stator defining a helical stator lumen and a helical rotor extending through the helical stator lumen, and wherein a pitch of the helical stator lumen is approximately twice a pitch of the helical rotor. 7. The apparatus of claim 1, wherein the progressive cavity pump comprises a stator and a rotor arranged to form a cavity therebetween, and wherein the cavity is fluid sealed due to compression between the stator and the rotor. 8. The apparatus of claim 1, wherein the progressive cavity pump comprises a stator and a rotor arranged to form a cavity therebetween, and wherein the cavity is unsealed due to a spacing gap between the stator and the rotor. 9. The apparatus of claim 1 wherein the progressive cavity pump comprises a rotor, the apparatus further comprising a torque member extending through the lumen and coupled to the rotor, the torque member operable to transmit a torque applied to a proximal end of the torque member to the rotor. 10. The apparatus of claim 1, wherein the progressive cavity pump includes a rotor, the apparatus further comprising a motor coupled to the rotor and operable to drive the rotor. 11. The apparatus of claim 1 , wherein the distal end of the catheter comprises an angled tip. 12. The apparatus of claim 1, wherein the distal portion has an outer diameter of from about 6 French and including to about 20 French and including. 13. The apparatus of claim 1, wherein the progressive cavity pump forms a seal between the lumen and the external environment. 14. The apparatus of claim 1, further comprising a handle assembly coupled to the proximal end of the catheter, wherein the handle assembly includes a drive system for controlling the progressive cavity pump. 15. The apparatus of claim 1 further comprising a distal pumping assembly coupled to the distal end of the catheter and comprising the progressive cavity pump, wherein the distal pumping assembly comprises a sleeve coupled to a stator of the progressive cavity pump and rotationally fixing the stator of the progressive cavity pump relative to the sleeve. 16. The apparatus of claim 1 further comprising a distal pumping assembly disposed within the distal end of the catheter and comprising the progressive cavity pump. 17. The apparatus of claim 1 , further comprising a distal pumping assembly coupled to the distal end of the catheter and comprising the progressive cavity pump, wherein the progressive cavity pump comprises each of a stator and a rotor, the distal pumping assembly comprising a locating element disposed at a proximal end of the stator, and the locating element being configured to maintain an axial relationship between the stator and the rotor during operation of the distal pumping assembly. 18. A method comprising: Positioning a material removal device within a physiological lumen or cavity of a patient, the material removal device comprising: a catheter comprising a catheter lumen extending through the catheter; and a progressive cavity pump at the distal portion of the catheter, wherein the progressive cavity pump is in communication with each of the catheter lumen and the physiological lumen or cavity of the patient; The progressive cavity pump is actuated to uptake material from the physiological lumen or cavity into the catheter lumen. 19. The method of claim 18, further comprising delivering the material through the catheter lumen to a container disposed outside the patient's body and in communication with the proximal end of the catheter lumen. 20. The method of claim 18, wherein the progressive cavity pump comprises a stator and a rotor arranged to form a cavity therebetween, wherein actuating the progressive cavity pump ingests the material into the cavity.