Device and method for removing material from a patient - Patents.com

Abstract

A pump assembly is used to remove material from a patient. The pump assembly is at the distal end of the catheter and can be advanced through a blood vessel. A stator and a rotor form the pump assembly and a tissue engaging portion that removes material from the patient as the rotor rotates.

Description

[Technical field]

[0001] Government Licensing Rights This invention was made with Government support under R41 NS129430 awarded by the National Institutes of Health. The Government has certain rights in this invention.

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Patent Application No. 63 / 315,764, entitled "DEVICES AND METHODS FOR ADMINISTERING AND REMOVING MATERIAL FROM A PATIENT," filed March 2, 2022, U.S. Provisional Patent Application No. 63 / 359,990, entitled "DEVICES AND METHODS FOR ADMINISTERING AND REMOVING MATERIAL FROM A PATIENT," filed July 11, 2022, and U.S. Provisional Patent Application No. 63 / 415,201, entitled "DEVICES AND METHODS FOR REMOVING UNWANTED MATERIAL FROM A PATIENT," filed October 11, 2022. The entire contents of the foregoing are incorporated herein by reference for all purposes.

[0003] FIELD OF THE DISCLOSURE The present disclosure relates generally to the field of medicine, and more specifically to the field of interventional radiology.Described herein are devices and methods for removing unwanted material from a patient. [Background technology]

[0004] Removal of material from patients is an important part of routine and emergency medical care. For example, in the field of interventional radiology, removal of blood clots (including thrombi or thromboemboli) from blood vessels or artificial vascular grafts is known as thrombectomy, and various devices have been proposed to address this need. Disadvantages of some existing devices include, but are not limited to, heavy bleeding during clot removal, difficulty in removing various clot compositions including both soft and hard clots, difficulty in removing clots attached to the vessel wall, injury to the vessel during thrombectomy, large device size, fragmentation of the clot during removal and subsequent embolization, and the amount of capital equipment required for device operation. A device capable of removing material (e.g., clots, stones, malignant tissue) from a body lumen or cavity that overcomes some or all of these disadvantages would be advantageous.

[0005] overview The present invention is directed to devices and methods for removing material from a patient. In one application, the devices and methods are used to remove blood clots during a thrombectomy procedure. The device may include a tissue engaging portion, a pump assembly, a catheter body, a handle assembly, and a collection assembly. When the device is actuated, the blood clot is engaged by the tissue engaging portion, drawn into the pump 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.

[0006] In one implementation, the pump assembly includes a rotor and a stator that form a cavity or pocket, and as the rotor rotates, material is moved through the cavity or pocket into the catheter body. In one implementation, the pump assembly is a progressive cavity pump. In one example, the rotor extends into a tissue engaging portion at the distal end of the device. When actuated, the tissue engaging portion creates a mechanical and / or vacuum assisted engagement of the clot and material (e.g., blood and clot) such that the clot and material (e.g., blood and clot) are captured from the distal end of the tissue engaging portion into the pump assembly, and the pump assembly is configured to create sufficient pressure to move the material through the handle assembly into the catheter body and further into the collection assembly. The tissue engaging portion can also help minimize clot fragmentation and subsequent embolization. By engaging the clot, optimizing the size of the cavity, and controlling the rotational speed of the rotor, blood loss can also be minimized.

[0007] In some cases, the pump assembly may be further configured to be positioned at a predefined or adjustable angle from the axis of the catheter body, in which case the catheter body may be rotated via the handle assembly to better engage clots within large vessels or attached to vessel walls, which may also allow for the utilization of a more compact device.

[0008] In some implementations, the pump assembly can be slidably disposed within the engagement catheter to aid in uptake of a substance into the catheter.

[0009] The above is a summary and may be limited in detail. The above-mentioned aspects, as well as other aspects, features, and advantages of the present technology, are described below in conjunction with various implementations with reference to the specification, claims, and accompanying drawings. [Brief description of the drawings]

[0010] [Figure 1]FIG. 1A illustrates an isometric view of an implementation of a device according to the present disclosure.

[0011] [Figure 1B] FIG. 1B is an exploded component view of the device of FIG. 1A.

[0012] [Figure 2A] FIG. 2A shows the device of FIG. 1A in a detailed view of the distal end.

[0013] [Figure 2B] FIG. 2B illustrates the device of FIG. 1A in an exploded component view.

[0014] [Figure 2C] FIG. 2C is a front view of the sized pump assembly.

[0015] [Figure 2D] FIG. 2D is a side view of a sized pump assembly.

[0016] [Figure 2E] FIG. 2E illustrates a representative flow equation for the pump assembly.

[0017] [Figure 3A] FIG. 3A shows the device of FIG. 1A in an initial configuration with the stator and distal sleeve transparent.

[0018] [Figure 3B] FIG. 3B shows the device of FIG. 1A with the rotor partially rotated and the first cavity beginning to form.

[0019] [Figure 3C] FIG. 3C shows the device of FIG. 1A with the rotor rotated further.

[0020] [Figure 3D]FIG. 3D shows the device of FIG. 1A after the rotor has rotated further and a second cavity has begun to form.

[0021] [Figure 3E] FIG. 3E shows the device of FIG. 1A with the rotor rotated further.

[0022] [Figure 3F] FIG. 3F shows the device of FIG. 1A with the rotor rotating further and a third cavity beginning to form.

[0023] [Figure 4] FIG. 4 illustrates an exploded component view of an implementation of a handle assembly for the device of FIG. 1A.

[0024] [Diagram 5] 5 is a cross-sectional view of the handle assembly of FIG.

[0025] [Figure 6A] FIG. 6A shows the device of FIG. 1A approaching a clot in a blood vessel.

[0026] [Figure 6B] FIG. 6B shows the device of FIG. 1A engulfing a blood clot in a blood vessel.

[0027] [Figure 6C] FIG. 6C shows the device of FIG. 1A further engulfing the blood clot within the vessel.

[0028] [Figure 6D] FIG. 6D shows the device of FIG. 1A further engulfing the blood clot within the vessel.

[0029] [Figure 6E] FIG. 6E shows the device of FIG. 1A further engulfing the blood clot within the vessel.

[0030] [Figure 7] FIG. 7 illustrates an implementation of a device according to the present disclosure removing a blood clot from an iliac vein.

[0031] [Figure 8] FIG. 8 illustrates an implementation of a method of use of the device of FIG. 1A.

[0032] [Figure 9A] FIG. 9A illustrates a pump assembly that can be incorporated into implementations of the present disclosure.

[0033] [Figure 9B] FIG. 9B illustrates an alternative pump assembly that can be incorporated into implementations of the present disclosure.

[0034] [Figure 10A] FIG. 10A illustrates another alternative pump assembly that can be incorporated into implementations of the present disclosure.

[0035] [Figure 10B] FIG. 10B is an exploded component view of the implementation shown in FIG. 10A.

[0036] [Figure 11A] FIG. 11A shows the device of FIG. 10A in a cross-sectional view in an initial configuration.

[0037] [Figure 11B] FIG. 11B shows the device of FIG. 10A with the rotor partially rotated.

[0038] [Figure 11C] FIG. 11C shows the device of FIG. 10A with the rotor rotating further.

[0039] [Figure 12A]FIG. 12A shows an implementation of a device having suction and injection channels.

[0040] [Figure 12B] FIG. 12B shows an implementation of a device with suction and injection channels.

[0041] [Figure 13A] FIG. 13A shows an implementation of a device having a stator with uniform wall thickness.

[0042] [Figure 13B] FIG. 13B is an exploded component view of the implementation shown in FIG. 13A.

[0043] [Figure 14A] FIG. 14A illustrates an implementation of a tissue engaging portion of a device according to the present disclosure including an extension feature.

[0044] [Figure 14B] FIG. 14B illustrates an alternative tissue engaging portion implementation that includes a stator funnel.

[0045] [Figure 14C] FIG. 14C illustrates yet another tissue engaging portion implementation including a rotor extension tip.

[0046] [Figure 14D] FIG. 14D illustrates another tissue engaging portion implementation that includes an extension wire.

[0047] [Figure 14E] FIG. 14E illustrates another tissue engaging portion implementation that includes a capped end.

[0048] [Figure 14F] FIG. 14F illustrates another tissue engaging portion implementation that includes standoffs.

[0049] [Figure 14G] FIG. 14G illustrates another tissue engaging portion implementation that includes an injection outlet.

[0050] [Figure 14H] FIG. 14H illustrates another tissue engaging portion implementation that includes an injection outlet.

[0051] [Figure 15A] FIG. 15A illustrates an implementation of a device according to the present disclosure including a guidewire insertion hole.

[0052] [Figure 15B] FIG. 15B is a cross-sectional view of the device of FIG. 15A.

[0053] [Figure 15C] FIG. 15C is a side view of a device having multiple distal bends.

[0054] [Figure 16A] FIG. 16A is a front view of a device according to the present disclosure including a visualization assembly.

[0055] [Figure 16B] FIG. 16B is an isometric view of the device in FIG. 16A.

[0056] [Figure 16C] FIG. 16C is an exploded view of the device in FIG. 16B.

[0057] [Figure 17A] FIG. 17A is a front view of a device according to the present disclosure that includes two visualization assemblies.

[0058] [Figure 17B] FIG. 17B is an isometric view of the device in FIG. 17A.

[0059] [Figure 17C]FIG. 17C is an exploded view of the device in FIG. 17B.

[0060] [Figure 18A] FIG. 18A shows an aspiration catheter approaching a clot within a blood vessel.

[0061] [Figure 18B] FIG. 18B shows an aspiration catheter engaging the clot of FIG. 18A.

[0062] [Figure 18C] FIG. 18C illustrates a device according to the present disclosure engaging the clot of FIG. 18A.

[0063] [Figure 18D] FIG. 18D shows the device of FIG. 18C removing the clot of FIG. 18A.

[0064] [Figure 18E] FIG. 18E shows the state in which the blood clot in FIG. 18A has been removed.

[0065] [Figure 19A] FIG. 19A illustrates an implementation of a device according to the present disclosure that includes a filter.

[0066] [Figure 19B] FIG. 19B shows the device of FIG. 19A with the filter shown in an exploded view.

[0067] [Figure 19C] FIG. 19C illustrates another implementation of a device according to the present disclosure that includes a series of filters.

[0068] [Figure 20] FIG. 20 illustrates an implementation of a device according to the present disclosure having a catheter filter.

[0069] [Figure 21]FIG. 21 illustrates an implementation of a device according to the present disclosure having an expandable funnel.

[0070] [Figure 22] FIG. 22 illustrates an implementation of a device according to the present disclosure having a pump assembly in the handle. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0071] Detailed Description Conventionally known removal devices include a variety of mechanisms and approaches for removing unwanted material from a patient. Some devices include suction catheters, which use a vacuum pump connected to the catheter to suck material, such as a blood clot, out of the blood vessel like a straw. Suction catheters can be problematic with thicker material, such as subacute or chronic clots, that do not easily compress into the catheter lumen and can clog such instruments. Additionally, suction catheters can harmfully generate significant suction flows, removing large amounts of blood from the patient. Doing so increases the risk of blood loss and the need for blood transfusions, among other risks.

[0072] Certain prior art removal devices have been described as using expandable metal frames and baskets to mechanically grasp and pull unwanted material, such as clots, from blood vessels. These devices can cause vascular injury to the intimal wall, venous valves, or other tissue structures, especially when removed from the patient. Additionally, these devices can allow fragments of unwanted material to embolize or travel further downstream in the blood vessel, thereby increasing the risk of other problems, such as pulmonary embolism and stroke.

[0073] Still other conventional devices use rotating elements to ablate unwanted material, which may include thrombus and wall-attached plaque. Devices using rotating elements are highly damaging to vascular structures and prone to clogging, especially in comparison to other material removal devices and methods. These devices also often require significant capital equipment to control and may require a separate suction source to remove the material once it has been ablated.

[0074] Described herein are devices and methods that overcome, among other things, the challenges described above while providing substantial additional benefits associated with the removal of waste from a patient. In use, the disclosed devices are generally inserted into a physiological lumen or body cavity of a patient in close proximity to the material to be removed from the patient. In one aspect of the disclosed devices, the devices include a pump for generating suction such that there is little dead volume between the pump and the waste material to be removed. In some embodiments, the pump is a positive displacement pump and 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, i.e., the volume of fluid between the pump and the waste material in situ, is minimized, and in some cases negligible. By reducing the amount of dead space, head loss through the tubing is minimized and the pump can provide a greater vacuum to the waste material. The pump can then expel the waste material through the lumen of the catheter and out of the patient. Additionally, an advantage of positive displacement pumps is that they do not require a high flow rate to generate a high level of vacuum, thereby minimizing blood loss associated with conventional suction catheters.

[0075] A positive displacement pump moves fluid by repeatedly trapping a fixed volume and mechanically circulating it through a system. 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 can be used for material removal and are within the scope of this disclosure, progressive cavity pumps (also known as Moineau pumps, eccentric screw pumps, or progressing cavity pumps) are particularly suited for removing unwanted material from a patient. Progressive cavity pumps include a stator with a slotted helical bore and a rotating helical rotor. The stator and rotor are designed such that, as they interface, one or more cavities are formed between the helical rotor and the stator helical bore. As described in more detail below, the cavities can contain a volume of fluid that can be completely sealed (e.g., by 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 "leaky" configuration can reduce the volume of certain fluids (e.g., blood) pumped by a progressive cavity pump while still facilitating the uptake of solid / semi-solid materials and more viscous fluids. From a hematological perspective, the result is reduced blood loss and a lower risk of a patient needing a blood transfusion.

[0076] In certain implementations of the present disclosure, the pitch of the helical rotor is approximately half the pitch of the stator helical bore. Rotating the rotor causes one or more cavities to move along the axis of the pump, depending on the direction the rotor rotates. Progressive cavity pumps differ from other pumps that incorporate helical elements, such as Archimedes screw pumps, also known as water screw pumps. A typical design of an Archimedes screw pump includes a cylindrical screw that rotates within a cylindrical or tubular bore. Such pumps do not include or form a closed cavity between the stator and rotor, and often use a pressure difference created by the rotational speed of the screw to draw fluid into the pump. A particular Archimedes screw design may work well for pumping viscous fluids such as blood, but may have problems with thicker materials such as blood clots. In contrast, progressive cavity pumps form a series of closed cavities that are fully or partially sealed. In operation, progressive cavity pumps move a discrete volume with each revolution of the rotor. As a result, the output of a progressive cavity pump is directly proportional to the number of revolutions of the rotor and is not dependent on the rotational speed (as with pressure-driven pumps such as conventional screw pumps). Thus, progressive cavity pumps have applications where the volume of fluid delivered must be well controlled, such as in drug delivery applications. The controlled flow rate provided by progressive cavity pumps is also advantageous in terms of material removal, as it overcomes some of the challenges associated with existing thrombectomy devices, where excessive blood loss is difficult to control. Furthermore, as briefly mentioned above, progressive cavity pumps are also suitable for applications where the material being delivered is viscous or includes slurries of solid material, such as in thrombectomy procedures, and can overcome some of the disadvantages of existing thrombectomy devices that clog with thick materials. However, progressive cavity pumps tend to be larger, more expensive, and more complex than feasible for use with catheters. For example, conventional progressive cavity pumps are often used in large applications such as pumping sewage or oil.In such applications, progressive cavity pumps have considerable mechanical complexity due to the various bearings and universal joints required.

[0077] In certain implementations, the progressive cavity pump may further include elements to improve material removal. For example, the distal end of the pump assembly may include a tissue engaging portion configured to not only apply suction, but also to mechanically grasp or pinch the material, thereby drawing elastic, thick materials into the pump assembly.

[0078] 1A, a device 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 pump 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 through mechanical interaction with the material and / or through the generation of aspiration flow or vacuum pressure that draws the material into the tissue engaging portion 108.

[0079] 1B depicts further details of the device 102. In the illustrated implementation, the pump assembly 110 includes a stator 114, a rotor 116, a distal sleeve 120, and a positioning element 118. The stator 114 fits within the distal sleeve 120, which is connected to the catheter body 104 and the positioning element 118. The rotor 116 is attached to and rotates with a torque member 122. The handle assembly 106 includes a catheter hub 124 for rotating the catheter body 104, a housing 126 constructed of two shells, a drive system 130 for enabling rotation of the torque member 122, and a manifold 128 for sealing the drive system 130 from the removed material and directing the removed material through an outlet tube 132 to the collection assembly 112. The handle assembly 106 further includes an electrical cable 134 and a controller 136.

[0080] In one implementation, the pump assembly 110 is a progressive cavity pump, with a series of cavities formed between the rotor 116 and the stator 114 that move proximally when the rotor 116 rotates in one direction and move distally when the rotor 116 rotates in the opposite direction. Progressive cavity pumps are also known as eccentric screw pumps, progressing cavity pumps, Moineau pumps, etc. Progressive cavity pumps are suitable for applications requiring metering of fluids, pumping of viscous or shear sensitive materials, and pumping of slurries containing abrasive solids.

[0081] 2A, a detailed view of the distal end of the device 102 is shown, further illustrating the tissue engaging portion 108 and the pump assembly 110. Generally speaking, the tissue engaging portion 108 includes elements that mechanically engage tissue to facilitate subsequent uptake of the tissue by the device 102. In certain implementations, the tissue engaging portion 108 includes a rotor distal tip 212 (shown in FIG. 2B) of the rotor 116, a stator distal portion 202 of the stator 114, a slot 220 defined by the stator 114, and portions of the distal sleeve 120.

[0082] In the illustrated implementation, the stator distal portion 202 extends from the distal sleeve 120 and is oriented with a stator alignment feature 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 therethrough, forming an open cavity 222 at the distal end of the device 102. As the rotor 116 rotates, the rotor distal tip 212 rotates and translates across the slot 220. This action mechanically engages the material (e.g., by pinching or entangling the material between the rotor distal tip 212 and the walls defining the slot 220). The pump assembly 110 can also generate suction flow and / or vacuum pressure to draw tissue / material into the open cavity 222. In doing so, the device 102 draws the substance into the pump assembly 110 for subsequent removal from the patient.

[0083] In certain implementations, the distal sleeve 120 may include a distal bend 206 that orients the distal sleeve 120 at an angle relative to the catheter body 104. The distal bend 206 may enhance the ability of the tissue engaging portion 108 to engage material (e.g., thrombus) attached to the vessel wall and / or extend the reach of the device 102, e.g., to treat larger vessels without requiring a larger diameter device. In certain implementations, the distal bend 206 may be adjustable or shapeable. For example, the catheter body 104 may include one or more manipulation features (e.g., pull cables) that may be used to manipulate and lock the distal bend 206.

[0084] As previously mentioned, the stator 114 includes a slot 220 (which may be obround in shape) in its distal surface. The slot 220 continues in a spiral manner through the stator 114 to form the stator helical bore 210. In certain implementations, the stator 114 may be formed from a resilient material, such as silicone, polyurethane, or any other suitable material that may be formed or otherwise molded to include the stator helical bore 210. Among other things, the use of a resilient material facilitates sealing of the stator 114 to the rotor 116. In certain non-limiting examples, the material of the stator 114 may have a durometer of about Shore 20A to about Shore 100D (inclusive), about Shore 20A to about Shore 60D (inclusive), or about Shore 80A. In other implementations, the stator may be constructed of a more rigid material, such as plastic, stainless steel, or any other suitable material.

[0085] The rotor 116 generally has a rotor helix 214 having a shape similar to the stator helix bore 210, but with a reduced pitch. For example, in certain implementations, the pitch of the rotor helix 214 may have about half the helical pitch of the stator helix bore 210 (or stated another way, the stator helix bore 210 may have about twice the pitch of the rotor helix 214). Alternative shapes of the stator helix bore 210 and the rotor helix 214 may be configured to have similar functionality, as described further below in this disclosure.

[0086] 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 plastics or metals). In certain implementations, the rotor 116 may be formed from 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 from a material that is harder or stiffer than the material of the stator 114. In particular, selecting a harder / stiffer material for the rotor 116 and a more elastic / compliant material for the stator 114 facilitates sealing between the rotor 116 and the stator 114 during operation.

[0087] The geometry of the stator 114 and rotor 116 generally forms a helical contact or near contact path. During operation, at least one closed cavity 224 is formed in the space between the rotor helix 214 and the stator helical lumen 210. More specifically, as the rotor 116 rotates within the stator 114, a cavity is formed between the rotor 116 and the stator 114, which moves proximally toward the catheter body 104 as the rotor 116 rotates. For example, FIG. 2D illustrates an open cavity 222 and a closed cavity 224, respectively. During operation, material is initially trapped within the open cavity 222. As the rotor 116 rotates further, the open cavity 222 moves proximally and eventually closes, forming a closed cavity such as the closed cavity 224. As the rotor 116 rotates further relative to the stator 114, the closed cavity 224 eventually advances to the proximal end of the stator helical lumen 210 and opens, releasing the trapped material into the catheter body 104. In this manner, material drawn into the pump assembly 110 is trapped within the closed cavity 224 and then travels into the catheter body 104 for removal from the patient. Among other advantages, this method allows for the removal of material (e.g., clots) without removing excessive amounts of fluid (e.g., blood).

[0088] In one implementation, the closed cavity 224 is fluidly sealed. For example, the seal can be achieved by contact between the stator 114 and the rotor 116, and in some implementations where the stator 114 and the rotor 116 have an interference fit, by additional compression of the stator 114 by the rotor 116. By way of example, the compression of the stator 114 by the rotor 116 can be between about 0% and about 40% compression, inclusive, between about 2% and about 10% compression, inclusive, or about 5% compression. The compression does not have to be the same over the entire length of contact between the stator 114 and the rotor 116.

[0089] In other implementations, the closed cavity formed between the stator 114 and the rotor 116 may not be fluidly sealed, i.e., a clearance gap may exist between the rotor 116 and the stator 114. Even without a completely sealed cavity, the pump assembly 110 may perform similarly, particularly when removing solid materials, as if it had a sealed cavity. In certain implementations, the clearance gap may beneficially reduce friction between the stator 114 and the rotor 116, since there is no contact or elastic interference between the two components. The clearance gap may also allow for greater tolerance variation in the rotor 116 and the stator 114, allowing both components to be made of a stiffer material. The inclusion of a clearance gap may also reduce the flow rate through the pump assembly 110, for example, by allowing distal leakage of fluid from the pump assembly 110. Among other benefits, such leakage may result in the removal of solid or semi-solid materials from the patient without removing substantial amounts of blood or other fluids. By way of example, the ratio of removed blood to removed clot can be from about 1:10 to about 50:1, inclusive, from about 1:1 to about 20:1, inclusive, or about 10:1. For purposes of this disclosure, and unless otherwise specified, cavities described within this disclosure as "closed" should be considered to encompass both fluidly sealed and unsealed cavities.

[0090] The illustrated pump assembly 110 includes a distal sleeve 120 for receiving the stator 114 and providing support such that the stator 114 is 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 portion 208 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 portion 202 maintains a tubular shape.

[0091] Certain implementations include a distal bend, the distal bend of the distal sleeve 120. 1 The distal bend 106 generally angles the tip of the device away from the axis of the catheter body 104. The angle of the distal bend 106 can be from about 0° to about 75°, inclusive, from about 10° to about 45°, inclusive, or about 20°.

[0092] In certain implementations, the distal sleeve 120 may comprise a laser cut stainless steel or Nitinol tube, a plastic tube, an injection molded part, a machined part, or any other suitable construction.

[0093] In certain implementations, the pump assembly 110 may include a positioning element 118 that resides inside the distal sleeve 120 and engages the stator 114 and rotor hub 216 such that the axial position of the rotor 116 is maintained relative to the stator 114. The positioning element may include a distal hard stop, a proximal hard stop, or other alignment feature that positions the rotor 116 or stator 114 both axially and rotationally. Among other things, the positioning element 118 ensures that the distal end of the rotor 116 is in the correct axial position and, in some implementations, does not extend beyond the distal end of the stator distal portion 202, which may lead to vascular injury. The positioning element 118 may further engage an internal feature (e.g., a shoulder, a slot, a protrusion, a key, a keyway, 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 implementations, the positioning element 118 is a separate component, and in other implementations, the positioning element 118 is a feature of (e.g., integrally formed with or coupled to) the stator 114 or the distal sleeve 120.

[0094] The torque member 122 is connected to the rotor 116 (e.g., via a rotor hub 216) such that as the torque member 122 rotates, the rotor 116 also rotates. The torque member 122 can be of various configurations, such as wire rope, cable, tubing, wire, or any other suitable structure for rotating the rotor 116. More generally, the torque member 122 has a structure and / or is formed of a material such that the torque member 122 has sufficient torsional stiffness to transmit torque to the rotor 116 while retaining sufficient bending flexibility to facilitate movement through the patient's physiological lumen. The torque member 122 can be of different configurations depending on the particular application to accommodate different flexibility needs. For example, a more flexible torque member may be used in applications involving more complex curved shapes or stiffer physiological lumens, while a stiffer torque member may generally be used in applications where the patient's physiological lumen is straighter, larger, or more flexible. The torque member 122 may include a torque member crimp 218 at one end that facilitates connection to the rotor 116 (e.g., to the rotor hub 216). In some cases, the rotor 116 and the torque member 122 are a single piece, with the rotor 116 being molded to the torque member 122, integrally formed with the torque member 122, or coupled to the torque member 122.

[0095] The device 102 may further include various radiopaque materials, such as marker bands or components constructed of radiopaque materials, so that the device 102 may be visualized 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, titanium, gold, tungsten, stainless steel, or any other suitable radiopaque material. The marker band may be positioned near the distal tip of the device 102 to provide feedback to the user regarding the position of the tip. In other implementations, the stator 114 or rotor 116 or distal sleeve 120 may be constructed of a material with a radiopaque additive, such as barium sulfate, bismuth, tungsten, or any other suitable additive.

[0096] 2C and 2D show additional views of the pump assembly 110, further illustrating certain dimensions. In general, the size of the device 102 may be adapted for various applications and may be configured (e.g., sized) 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 potential clot volumes involved in such procedures, implementations may include configurations in which the outer diameter ODs of the stator and the outer diameter of the catheter body 104 are between about 1 mm (3 Fr) and about 8 mm (24 Fr), inclusive. In one specific example, the outer diameter ODs may be about 5.3 mm or 16 Fr. The length Ls of the stator may also vary depending on the application. However, as a non-limiting example, for an application intended to treat deep vein thrombosis, Ls may be between about 1 mm and about 30 mm, inclusive, or about 10 mm.

[0097] The total number of turns of the stator bore can also vary. For example, in certain implementations, the stator helical bore 210 can include between about 0.5 turns and about 10 turns, inclusive, or about 1 turn of the stator helical bore 210.

[0098] The cross-sectional diameter Dr of the rotor may also vary, however, in certain implementations, Dr may be between about 0.1 mm and about 4 mm, inclusive, or about 2 mm.

[0099] In the implementation shown in Figures 2A-2D, rotor spiral 214 has a circular shape, although other geometric shapes are contemplated and within the scope of the present disclosure.

[0100] The stator helical bore 210 can have a stator pitch Ps, and the rotor helical portion 214 can have a rotor pitch Pr that is a fractionally shorter than Ps. For example, Pr can be about 0.25 to about 0.75 times, inclusive, or about 0.5 times Ps. For example, the rotor pitch Pr can be about 5 mm, the corresponding stator pitch Ps can be about 10 mm, and the length Ls of both helical elements can be about 10 mm. In such a configuration, the stator helical bore 210 will make about one revolution and the rotor helical portion 214 will make about two revolutions.

[0101] The stator slot 220 may be defined by an eccentricity Es. In certain non-limiting examples, the eccentricity Es may be about 0.1 mm to about 4 mm, inclusive, or about 2 mm. Similarly, the rotor helix 214 may be defined by an eccentricity Er. The rotor eccentricity Er may correspond to a fraction of the stator eccentricity Es. In certain implementations, the rotor eccentricity Er may be about 0.25 to about 0.75, inclusive, or about 0.5 times the stator slot eccentricity Es. In the illustrated implementation, for example, the rotor eccentricity Er is about 1 mm and the stator slot eccentricity Es is about 2 mm.

[0102] As previously discussed and illustrated in FIG. 2D, the stator 114 and rotor 116 may be selected to have a clearance gap G therebetween. In some implementations, the rotor 116 and the stator 114 have an intentional interference to provide a completely sealed closed cavity 224. In such cases, the clearance gap G may be characterized as a negative value. For example, the clearance gap G may be between about -0.01 mm and about -0.5 mm, inclusive, or about -0.05 mm. The negative clearance gap G may alternatively be expressed as a percentage of compression, as discussed above.

[0103] In implementations where there is an intentionally 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 clearance gap G may be between about 0.0 mm and about 1.0 mm, inclusive, between about 0.05 mm and about 0.25 mm, inclusive, or about 0.01 mm. In such implementations, the cavity formed between the stator 114 and the rotor 116 is an unsealed cavity. Among other things, a 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 the rotor 116 easier to rotate, and allowing both the rotor 116 and the stator 114 to be constructed of stiffer materials.

[0104] In the illustrated implementation, each closed cavity 224 formed between the stator helix bore 210 and the rotor helix 214 has a respective volume. The volume of each cavity may vary depending on the size and shape of the components of the device 102, but in at least certain implementations, the volume of each cavity may be between about 1 μl and about 200 μl, inclusive, or about 17 μl.

[0105] Since each cavity represents a constant volume defined by the space between the rotor helix 214 and the stator helical bore 210 formed during the rotation of the rotor 116, 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 rate Q of the pump assembly 110 in radians per second for a given rotational speed Ω of the rotor. For example, in the illustrated implementation, the rotor eccentricity Er is 1 mm, the rotor diameter Dr is 2 mm, and the stator pitch Ps is 10 mm. Based on a rotational speed Ω of 1,000 rpm or 104 rad / s, the flow rate Q is approximately estimated to be 40 cc / min. The design parameters may be adjusted as needed to change the characteristics of the pump assembly, including the flow rate Q, pump pressure, and other characteristics. The rotational speed of the drive system 130 may be in the range of about 1 rpm to about 120,000 rpm, inclusive, about 2,000 rpm to about 60,000 rpm, inclusive, or about 15,000 rpm.

[0106] A positive clearance gap between the stator 114 and the rotor 116 can reduce the flow rate of the pump assembly 110 by allowing fluid to slip through the clearance gap. This effectively reduces the expelled viscous material, such as blood, while still allowing thick or solid / semi-solid material to be entrained. In this way, the device 102 can more preferentially remove thick material. Although the equation in FIG. 2E does not take into account fluid slip through 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, such adjustments can be made, for example, computationally or based on empirical data. In particular, implementations including a positive clearance gap may not generate sufficient vacuum pressure and may also affect the flow and intake characteristics of the pump assembly 110.

[0107] 3A-3F show the operation of the pump assembly 110 in more detail by making the distal sleeve 120 and stator 114 transparent to observe the movement of the cavities. In FIG. 3A, the device 102 is shown in an initial configuration. The stator 114 is within the distal sleeve 120, and the rotor helix 214 is within the stator helix lumen 210. The rotor hub 216 is pressed against a 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 certain applications, the pump assembly 110 may already be filled with a fluid, such as water, saline, blood, grease, oil, etc., or conversely, the pump assembly 110 may be empty of material.

[0108] 3B is a view of the device 102 with the torque member 122 and rotor 116 partially rotated. As previously described, the rotor helix 214 interacts with the stator helical bore 210 as the rotor 116 rotates, such that the rotor helix 214 comes into contact or near contact with the stator helical bore 210 to define a cavity through which material is transported through the pump assembly 110.

[0109] As shown, the rotor hub 216 interacts with the positioning element 118 to ensure that the rotor 116 is in the correct axial position. More specifically, as the rotor 116 rotates clockwise, the interaction of the rotor 116 with the stator 114 exerts a distal force on the rotor 116. The positioning element 118 limits the distal movement of the rotor hub 216 and holds the distal rotor tip 212 in a desired position in the tissue engaging portion 108. In one implementation, the distal rotor tip 212 does not extend significantly beyond the stator distal portion 202 to reduce the risk of vessel injury. As the rotor 116 rotates, the rotor distal tip 212 descends into the distal slot 220, forming 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 pump assembly 110 and allows fluid or material to enter the stator 114. The material may be blood, a blood clot, or other material to be removed.

[0110] As the rotor 116 rotates further, as shown in FIG. 3C, the volume of the first open cavity 302 increases as the first open cavity 302 moves proximally to the pump assembly 110. In certain implementations, this action creates a negative pressure space that draws in fluid like a syringe. In the case of clot material, the tissue engaging portion 108 can grip or pinch the tissue, or otherwise create additional mechanical force on the tissue to draw it into the first open cavity 302. In particular, in FIG. 3C, the torque member 122 and 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 move proximally along the length of the stator 114, increasing in size and drawing in more fluid or material with either suction or mechanical force.

[0111] 3D shows the device 102 after further rotation of the rotor 116 (compared to FIG. 3C), which causes the rotor distal tip 212 to move upward, toward its initial position within the slot 220. As shown, the opening to the first open cavity 302 is reduced as the first open cavity 302 moves into the pump assembly 110. At the same time, a second open cavity 304 opens 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 implementation, the first open cavity 302 and the second open cavity 304 are separate cavities formed by contact made between the rotor 116 and the stator 114, and there is limited or no fluid communication between the first open cavity 302 and the second open cavity 304. In other implementations where a clearance gap exists between the rotor 116 and the stator 114 , there may be slight fluid communication between the first open cavity 302 and the second open cavity 304 .

[0112] FIG. 3E shows the device 102 after further rotation of the rotor 116 (compared to FIG. 3D) such that the rotor distal tip 212 returns to its initial configuration in the slot 220 shown in FIG. 3A. As shown, the first open cavity 302 shown in the previous figure is no longer exposed to the distal opening of the slot 220 and transitions into a first closed cavity 308 that moves proximally along the pump assembly 110 within the stator 114 as the rotor 116 continues to rotate. Stated differently, the first closed cavity 308 is a formed volume within the stator 114 that translates along the axis of the pump assembly 110. In the illustrated implementation, the first closed cavity 308 is not in fluid communication with either the external environment at the distal end of the pump assembly 110 or the lumen of the catheter body 104. As further shown in FIG. 3E, the second open cavity 304 is more open to the distal end of the pump assembly 110 so that a fluid or substance can be drawn in using vacuum and / or mechanical force.

[0113] FIG. 3F shows the device 102 after further rotation of the rotor 116 (compared to FIG. 3E). More specifically, the rotor 116 has been rotated another half turn such that the rotor distal tip 212 is back at the bottom of the slot 220. As shown, the first closed cavity 308 has 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 has now been drawn into the distal sleeve 120, and further rotation of the rotor 116 will expel any fluid or material within the first closed cavity 308 from the pump assembly 110 into the catheter body 104. As further shown in FIG. 3F, the second closed cavity 310 is now fully contained within the stator 114 (e.g., no longer open at the distal end of the pump assembly 110). Finally, a third open cavity 306 is formed at the distal end of the device 102 between the rotor helix 214 and the stator helical bore 210 to allow for the incorporation of a substance into the third open cavity 306 .

[0114] 3A-3F and described above, the rotor 116 can continue to rotate such that additional cavities are formed at the distal end of the device 102, translated through the pump assembly 110, and opening into the catheter body 104, each cavity carrying fluid and / or solid or semi-solid material. Stated another way, fluids and materials can be forced from around the distal device 102, through the pump assembly 110, and into the catheter body 104 by the pumping action of the pump assembly 110.

[0115] 4 and 5, an exemplary implementation of a handle assembly 106 for use in a device according to the present disclosure is shown. Among other things, the handle assembly 106 allows a user to control certain aspects of the functionality of the device 102, which will be described in more detail below. In the illustrated implementation, the handle assembly 106 includes a housing that includes a catheter hub 124, a drive system 130, a manifold 128, and two handle shells 126A, 126B. The catheter hub 124 is connected to the catheter body 104 and can be rotated by a user to rotate the catheter body 104 and thus the distal sleeve 120, the positioning element 118, and the stator 114. Such rotation is particularly useful when directing the tissue engaging portion 108 and the distal bend 206 to a particular region of attached tissue (e.g., attached clot) or blood vessel. This feature effectively increases the reach of the device 102, allowing larger diameter blood vessels to be treated without the need for a larger device.

[0116] The drive system 130 includes a torque member 122, a torque hub 410, a motor adapter 412, a motor plate 414, a motor 416, a throttle 418, a controller 136, and an electrical cable 134. The torque member 122 is housed within the catheter body 104 and enters the handle assembly 106 to engage the drive system 130. The torque member 122 passes through the catheter hub 124 and enters the manifold 128. The manifold includes two seal members 408A, 408B to prevent fluids and materials from entering the drive system 130. The proximal end of the torque member 122 includes a torque member hub 410 configured to be rotated by a motor 416. The motor 416 is attached to a motor plate 414 that holds it within the handle shells 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 causes rotation of the torque member 122. The electrical cable 134 provides power to the motor 416 and may in some cases include control inputs or outputs to the device 102. In other implementations, the electrical cable 134 may be replaced with a battery inside the handle shells 126A, 126B that provides power to the drive system 130 in lieu of an external power source. The handle assembly 106 further includes a throttle 418 and controller 136 that allows a user to control the operation and / or speed of the motor 416.

[0117] The outlet tube 132 is connected to the manifold 128 and directs fluids and materials away from the handle assembly 106 and into a collection assembly 112 (shown in FIG. 1A ) located outside the handle assembly 106. In other implementations, the device 102 can collect fluids and materials into the handle assembly 106 or into a collection assembly 112 located within the catheter body 104. In yet other implementations, the outlet tube 132 or collection assembly 112 can incorporate a filter to separate clot material from the blood, thereby allowing the blood to be reintroduced into the patient.

[0118] In certain implementations, the drive system 130 may be manually operated. For example, the motor adapter 412, the motor plate 414, the motor 414, the electrical cable 134, and the throttle 418 may be replaced with a mechanism (e.g., a knob, crank, handle, gear, etc.) that facilitates manually driving the rotation of the torque member 122.

[0119] FIG. 5 is a cross-sectional view of the handle assembly 106. The catheter hub 124 extends from the front of the housing shells 126A, 126B (shell 126B is shown in FIG. 4) to allow the user to rotate the catheter body 104 to guide the tissue engaging portion 108 (e.g., shown in FIG. 1A) around the blood vessel, as previously described. Seal members 408A, 408B, either incorporated within the manifold 128 or disposed at either end of the manifold 128, prevent leakage of fluid from the manifold 128. For example, the front seal member 408A can engage the catheter hub 124 such that the front seal member 408A maintains a fluid seal within the manifold 128 as the catheter hub 124 rotates. The rear seal member 408B can engage the torque member hub 410 to prevent leakage as the torque member hub 410 rotates. As shown in FIG. 5, the torque member hub 410 and the motor 416 are connected by a motor adapter 412. An outlet tube 132 connects to the manifold 128 and exits the handle shells 126A, 126B to the collection assembly 112 (shown in FIG. 1A ). The throttle 418 and controller 136 may be housed within and carried by the handle shells 126A, 126B, for example, within a handle or grip portion of the handle assembly 106.

[0120] In the illustrated implementation, the throttle 418 is a spring-return potentiometer that changes resistance when a user depresses a protruding plunger. Wires (not shown) from the potentiometer are connected to an electrical cable 134. The electrical cable 134 can be connected to a power supply or to a mains power source. In some implementations, a controller 136 can be external to the handle assembly 106 and is adapted to control the rotation and speed of the motor 416 via the electrical cable 134.

[0121] The handle assembly 106 shown in Figures 4 and 5 is intended merely as a non-limiting example of a handle that may be used in the practice of the present disclosure. In general, a handle assembly according to the present disclosure enables actuation of a pump assembly, for example, by causing rotation of a rotor within a stator of the pump assembly. As mentioned above, additional functionality provided by the handle may include, but is not limited to, rotating the catheter body and providing a channel through which captured fluids and materials may be transferred, filtered, or otherwise processed. Thus, while Figures 4 and 5 provide an exemplary implementation of a handle assembly, the handle assembly and associated control hub of a device according to the present disclosure are not limited to the particular configuration shown in Figures 4 and 5.

[0122] 6A-6E show device 102 at various stages in its use for a clot removal application, and in particular for a clot removal procedure. For example, the process shown in Figures 6A-6F may correspond to clot removal for a patient suffering from deep vein thrombosis, where the clot is in the iliofemoral vein, or pulmonary embolism, where the clot is in the pulmonary artery blocking normal blood flow. The procedures illustrated in Figures 6A-6E are provided by way of example only, and the present disclosure recognizes that the general process and functions illustrated in Figures 6A-6E may be readily adapted to other clinical applications.

[0123] 6A, the device 102 is shown within a blood vessel 604 having a clot 602 that is partially or completely blocking blood flow. In certain applications and procedures, the device 102 may be inserted into a patient's vascular system and navigated to the blood vessel using standard catheter techniques and devices.

[0124] At the time illustrated in Figure 6A, a user may actuate the device 102, for example, by depressing the throttle 418 of the handle assembly 106 (shown in Figures 4-5). Actuating the device 102 causes rotation of the torque member 122, which in turn rotates the rotor 116, thereby operating the tissue engaging portion 108 and pump assembly 110, for example, as described in Figures 3A-3F. The tissue engaging portion 108 may engage the clot 602 and initiate the uptake of blood and material through the pump assembly 110 and into the catheter body 104 and outlet tube 132 (e.g., shown in Figure 1A).

[0125] In some implementations, the pump assembly 110 can create a vacuum or suction pressure within the blood vessel 604 that can draw the clot 602 proximally. In some implementations, the vacuum pressure can be between about 0.5 inHg (1.693 kPa) and about 29.2 inHg (98.88 kPa), inclusive. Alternatively, the device 102 can be advanced forward (e.g., toward the clot 602) until the tissue engaging portion 108 contacts the clot 602, as shown in FIG. 6B.

[0126] 6B, the device 102 is advanced such that the tissue engaging portion 108 contacts the clot 602. As the rotor 116 continues to rotate, fragments of the clot 602 may be drawn into the slots 220 by suction flow or mechanical forces (e.g., grasping or pinching the clot 602 or fragments of the clot 602) and subsequently into the open cavity formed by the tissue engaging portion 108 and pump assembly 110 as previously discussed. The tissue engaging portion 108, which is comprised of tissue contacting elements such as the slots 220 and rotor distal tip 212, may both mechanically grasp the clot and / or move the clot by suction. As the cavity moves proximally, the clot 602 similarly moves through the pump assembly 110 and is expelled through the catheter body 104 and outlet tube 132 to the collection assembly 112.

[0127] In Figure 6C, the device 102 has removed a portion of the clot 602. The removed portion is within the catheter body 104 and is delivered from the patient, as previously described. In Figure 6D, the device 102 has advanced further, removing more of the clot 602 from the blood vessel 604 by the tissue engaging portion 108, and capturing the clot 602 within the device 102. In Figure 6E, the clot 602 has been completely removed from the blood vessel 604 and removed from the patient, for example, by transporting the clot 602 through the catheter body 104 and handle assembly 106 to a collection assembly 112 coupled to the handle assembly 106.

[0128] In FIG. 7, an implementation of the device 102 in an exemplary clinical application is shown. A blood clot 602 has formed in a patient's iliac vein 704. The blood clot 602 has restricted blood flow in the vessel, causing leg swelling and pain in the patient's lower extremities. Prior to inserting the device 102, an embolic distal protection element 718 can be optionally placed in the inferior vena cava 702 to protect dislodged or fragmented portions of the blood clot 602 from migrating to the heart and lungs. In one specific implementation, the distal protection element 718 can be an expandable container, such as a braided structure, that captures clot fragments but allows blood flow. Alternatively, the distal protection element 718 can include a non-porous element, such as a balloon or membrane, that completely blocks blood flow. The distal protection element 718 can be inserted through the jugular vein or other suitable access site and guided into the inferior vena cava 702 by standard interventional techniques, and then expanded within the vessel.

[0129] An introducer sheath 710 can be placed in the popliteal vein 708, which provides access to the patient's venous vasculature proximal to the clot 602. The device 102 can then be inserted into the introducer sheath 710 and directed to the clot 602 using standard interventional techniques. In some implementations, a longer introducer sheath or guide catheter is first placed proximal to the clot 602, and then the device 102 is inserted through the sheath or guide catheter. Various methods of guiding the device 102 to the clot 602 are contemplated. The catheter body 104 extends through the introducer sheath 710, the popliteal vein 708, and the femoral vein 706 to the proximal end of the clot 602 in the iliac vein 704.

[0130] In the illustrated implementation, the collection assembly 112 includes a filter assembly 712. The filter assembly 712 can include a series of meshes, such as mesh 714, that can separate the clots 602 from the blood after uptake by the device 102. The meshes can have pore sizes ranging from about 1 μm to about 500 μm, inclusive, or about 200 μm. In some implementations, there can be multiple meshes with different pore sizes to remove different component sizes. The filter assembly 712 can include a return tube 716 that connects to a port on the introducer sheath 710 that allows the separated blood to be reintroduced into the patient. In alternative implementations, the return tube 716 may connect to another vascular access site. The filter assembly 712 beneficially prevents excessive blood loss from the patient by returning the blood to the vascular system while allowing removal of clots or other similar material.

[0131] In the exemplary clinical application shown in Figure 7, the device 102 is actuated by a user with a corresponding control, such as throttle 418 on the handle assembly 106, to remove clot material and blood from the patient, as described in Figures 3A-3F. After some or all of the clot 602 has been removed, the device 102 and distal protection element 718 can be removed.

[0132] In other implementations, the device 102 can approach the clot 602 from above (i.e., from the opposite direction) via an access site in the jugular vein. In such implementations, the distal protection element 718 can optionally be configured to be located on the catheter body 104 or the distal sleeve 120. Alternatively, the device 102 can be inserted through the distal protection element 718, for example, by incorporating the distal protection element 718 into the introducer sheath 710 or guide catheter.

[0133] 8, a method 800 of treating a patient to remove material from a lumen or body cavity is provided. At step 802, a device according to the present disclosure is inserted into a patient and positioned within a lumen or body cavity containing the material.

[0134] In step 804, the device can be brought into either proximity or contact with the material, depending on whether suction is used to draw the material into the tissue engaging portion of the device.

[0135] In step 806, the device is actuated to begin drawing material into the device. In certain implementations, actuating the device may include actuating a pump assembly of the device. As previously described, such actuation may engage and begin drawing material into the catheter body of the device. For example, in implementations in which the device contacts the material in step 804, actuating the pump assembly may cause the pump assembly to mechanically engage the material. Actuating the pump assembly may also create suction to draw the material into the pump assembly instead of, or in addition to, mechanical engagement and transfer. Finally, actuating the device may also include, or alternatively, apply a separate suction source to draw the material into proximity or contact with the tissue-engaging portion of the device. The material may then be further captured by actuating the pump assembly of the device, for example, by mechanical engagement or suction / aspiration.

[0136] In step 808, the material is taken up into the device and thereby partially or completely removed from the lumen or body cavity by repositioning the tissue engaging portion or pump assembly as necessary, which may include advancing or retracting the device and / or rotating the tissue engaging portion or pump assembly through the catheter hub.

[0137] In step 810, the removed blood and material are typically collected for disposal, which may include filtering the material from other fluids (e.g., blood) to remove particulates and allow the fluid (e.g., blood) to be reintroduced into the patient.

[0138] In step 812, the device is removed from the patient's lumen or body cavity, and the clinical procedure is substantially complete.

[0139] In some implementations, the pump assembly 110 may be longer than the exemplary implementation shown in Figures 3A-3F. For example, in the implementation shown in Figures 3A-3F, the stator helical bore 210 has approximately one turn, allowing the rotor 116 to form a single closed cavity 224 within the stator 114. For purposes of this disclosure, such a configuration is generally referred to as a single stage pump / single stage pump assembly.

[0140] 2C and 2D, in other implementations, additional stages can be added by increasing the stator length Ls and the number of turns in the stator helical bore 210, and / or by decreasing the stator pitch Ps. Such changes can increase the number of closed cavities 224 formed by the rotor 116 and stator 114 during operation. Among other things, the additional pump stages may enable the pump assembly 110 to generate higher head pressures as compared to single stage embodiments.

[0141] With the foregoing in mind, in some implementations, the pump assembly 110 includes at least a single stage, while in other implementations, the pump assembly 110 can include any suitable number of stages, including, but not limited to, two stages, three stages, or up to five stages. In still other implementations, the pump assembly 110 can include more than five stages, for example, up to 100 stages. In the latter implementations, the pump assembly 110 can extend along a substantial portion up to the entire length of the catheter body 104. In still other implementations, the pump assembly 110 may not include a full stage, such that the number of helical turns of the stator helical lumen 210 is less than one turn.

[0142] 9A and 9B show additional implementations of the present disclosure. In FIG. 9A, the stator helical bore 210 and the rotor helical portion 214 form three closed cavities. Notably, a stator / rotor configuration that includes more cavities can allow for higher pressures and reduce the compression seal between the rotor 116 and the stator 114, or allow for clearance gaps such that the formed cavities are unsealed cavities.

[0143] FIG 9A illustrates an exemplary device in which the rotor distal tip 212 is generally circular and the stator helical lumen 210 is shaped to approximate an obround rectangular slot 220 in the illustrated front view. In contrast, FIG 9B illustrates an alternative implementation in which the rotor distal tip 212 has an oval profile and the stator helical lumen 210 is shaped to approximate a rounded triangular slot 220. Notably, such a configuration can form multiple open cavities in the tissue engaging portion 108, as illustrated by a first open triangular cavity 902 and a second open triangular cavity 904. The implementation illustrated in FIG 9B includes ten closed cavities along its length while having a shorter pitch than the implementation illustrated in FIG 9A.

[0144] More generally, the stator and rotor of implementations of the present disclosure may be configured to form any number of cavities during operation. For example, in certain implementations, the stator and rotor may be configured to form between 1 and about 200 cavities, inclusive. Implementations including a relatively large number of cavities may be facilitated by having the stator 114 extend a significant percentage or entirely through the entire length of the catheter body 104, and the stator helical lumen 210 and rotor helical portion 214 extend entirely through it. In other implementations, the rotor helical portion 214 may be longer than the stator helical lumen 210, such that it extends from the proximal end of the stator 114 into the distal sleeve 120 or into the catheter body 104.

[0145] 10A and 10B show another alternative implementation of the device 102. More specifically, in the embodiment of FIG. 10A and 10B, the distal sleeve 120 is generally straight and aligned with the axis of the catheter body 104. This is in contrast to some previously discussed implementations in which the device 102 included a distal bend. In one specific implementation shown in FIG. 10A and 10B, the stator length Ls may be about 20 mm, and the rotor 116 may include a short straight section between the rotor helix 214 and the rotor hub 216 (shown in FIG. 10B). FIG. 10B also illustrates the rotor hub 216 as including a spiral cut that may propel entrapped material into the catheter body 104 during operation / rotation of the rotor 116.

[0146] 11A-11C illustrate the operation of the implementation shown in FIGS. 10A and 10B. As shown, the rotor hub 216 engages with a positioning element 118, which is shown as an integral part of the distal sleeve 120. The positioning element 118 features axially positioning the rotor 116 relative to the stator 114 such that the rotor distal tip 212 is flush with the end of the stator distal portion 202 at the tissue engaging portion 108. In FIG. 11A, the pump assembly 110 is in an initial configuration with the rotor distal tip 212 at the top of the slot 220. At the slot 220, the cavity between the rotor helix 214 and the stator helix lumen 210 forms a first open cavity 302 that is open to the distal end of the device 102, allowing fluids and substances to enter the first open cavity 302.

[0147] In Figure 11B, the rotor 116 has rotated approximately one-quarter of a turn relative to the configuration shown in Figure 11A. As a result of the rotation, the rotor distal tip 212 has moved approximately halfway down the open slot 220. The opening to the first open cavity 302 has decreased as the cavity volume has moved into the pump assembly 110. The second open cavity 304 opens and fluid or material may enter this cavity as well. The first open cavity 302 and the second open cavity 304 may be separate fluid spaces that are partially or wholly sealed from one another.

[0148] In FIG. 11C, the rotor 116 has rotated another quarter turn relative to the configuration shown in FIG. 11B. As a result, the rotor distal tip 212 is now located 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 moved completely into the stator 114. The second open cavity 304 is now completely open to the distal end of the pump assembly 110 and fluid or material continues to be drawn into the cavity. As the rotor 116 continues to rotate, the first closed cavity 308 is forced into the catheter body 104 and then the second open cavity 304 is forced into the catheter body 104 as well. This process continues as new cavities formed in the stator distal portion 202 are drawn into the stator 114 and then into the catheter body 104. Thus, the assembly functions like a progressive cavity pump, drawing material into the stator 114 and expelling it back into the catheter body 104.

[0149] 12A and 12B, an implementation 1200 of the device 102 is shown that includes one or more additional channels 1202, 1204 in the tissue engaging portion 108 to facilitate infusion and / or aspiration. More specifically, compared to the previous implementation, the stator distal portion 202 is modified to include one or more additional channels in fluid communication with the catheter body 104.

[0150] In FIG. 12A, a suction inlet 1202 through which material can be removed and an infusion outlet 1204 through which material can be delivered are shown. In FIG. 12B, the implementation of FIG. 12A is shown in more detail in an exploded view. As shown, the stator 114 has channels along its outer surface that allow direct fluid communication between the distal end of the device 102 and the catheter body 104. In some implementations, these channels are lumens that run through the stator 114 or the distal sleeve 120. The suction channel 1206 connects the suction inlet 1202 to a suction outlet 1210 in the distal sleeve 120. The infusion channel 1208 connects the infusion outlet 1204 to an infusion inlet 1212 in the distal sleeve 120. The suction channel 1206 can be used to apply suction with a separately connected suction source, such as a pump or syringe, which can move and hold the clot in the tissue engaging portion 108 while the pump assembly breaks up and entrains the clot. For example, an aspiration syringe can be connected to the outlet tube 132, which is in fluid communication with the aspiration inlet 1202 via the aspiration channel 1206. When vacuum pressure is applied via the syringe, fluid can flow through the aspiration inlet 1202, thereby allowing the device 102 to draw material into and hold it there while the remainder of the tissue engaging portion 108 and the pump assembly 110 remove the clot. In this manner, the aspiration inlet 1202 can be an integral part of the tissue engaging portion 108.

[0151] Similarly, the injection inlet 1212 may be connected to a tube that allows a user to inject a substance into the distal end of the device 102 through the injection channel 1208. For example, a contrast agent may be injected into the front of the device 102. Alternatively, a drug or other clinically suitable substance may be injected. In other implementations, saline may be injected from the injection outlet 1204. This beneficially provides a low viscosity fluid to the pump assembly 110 to aid in the extraction of blood clots and reduce blood loss. Alternatively, the injected saline may be used to pressurize the blood vessel so that it does not collapse due to the negative pressure created by the pump assembly 110 or a separate suction source. The injected saline may also be used to assist the tissue engaging portion 108 in uptake of the substance. The pump assembly 110 may work better when the thick substance is mixed with a viscous liquid such as water, saline, blood, etc. The injected fluid may also be sprayed at a high velocity to provide for the disruption of the thick substance in the tissue engaging portion 108, thereby improving uptake performance. In some implementations, the infusion fluid may include saline and glucose, which may be used to flush blood from the blood vessel to improve visualization of the clot with techniques such as optical coherence tomography (OCT).

[0152] Protrusions or tubes in the catheter body 104 can be used to fluidly connect the aspiration outlet 1210 and the infusion inlet 1212 to the handle assembly 106. In the illustrated implementation, the channel 1206 and the channel 1208 are formed between the stator 114 and the distal sleeve 120 and are spirally wound around the stator 114 to avoid the stator helical lumen 210. In other implementations, the channels can be straight or in another non-helical pattern. In still other implementations, both channels can be the aspiration channel 1206 or the infusion channel 1208, or the device 102 can have only one channel or more than two channels. In still other implementations, the channels can be used for the insertion of a guidewire or other devices useful in standard catheterization procedures. For example, a guidewire can be inserted through one of the channels and used to deliver a device to a site within a lumen or body cavity of a patient.

[0153] 13A-13B show an alternative implementation 1300 of a device according to the present disclosure. More specifically, in contrast to the previously illustrated implementation, the device 1300 is shown with a stator 114 of 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 across the entire distal end of the device 102 and includes the stator supports 1302 without the distal sleeve 120.

[0154] In Figure 13B, the device 1300 of Figure 13A is shown in more detail in an exploded view. As shown, the stator 114 has a stator helical lumen 210 and slots 220 similar to the previous implementation. However, in contrast to the previously discussed implementation, the outer shape of the stator 114 is not cylindrical. Rather, the outer shape of the stator 114 matches the stator helical lumen 210 such that a generally uniform wall thickness is maintained throughout the stator 114. While the wall thickness may vary depending on the overall size and clinical use of the catheter, in certain exemplary implementations, the wall thickness may be about 0.1 mm to about 10 mm, inclusive, about 0.2 mm to about 1 mm, inclusive, or about 0.4 mm.

[0155] The stator support 1302 generally includes an inner surface that matches the outer shape of the stator 114. As the rotor 116 rotates within the stator 114, the stator helical bore 210 is compressed between the rotor helical bore 214 and the stator support 1302. Because the stator 114 has a substantially uniform wall thickness, the amount of compression and sealing performance may be maintained along the entire helical contact line. However, this disclosure contemplates that other outer geometries of the stator 114 are possible, and particularly implementations in which the stator 114 does not have a uniform wall thickness.

[0156] The device 1300 further includes suction channels 1206 that extend through the exterior surface of the stator support 1302. This configuration of the suction channels 1206 may be beneficial because they reside within the stator support 1302 and therefore do not affect the sealing of the stator 114. In certain implementations, the material of the stator support 1302 may be harder than the material of the stator 114, e.g., the stator support 1302 may be formed of a hard plastic or metal while the stator 114 is 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 material of the stator 114.

[0157] The stator support 1302 includes a positioning feature 1304 for interacting with the rotor hub 216. In the illustrated implementation, the positioning feature 1304 provides both distal and proximal positioning elements 118 for the rotating hub 216. Such positioning features 1304 may be incorporated into any implementation described herein. The implementation of FIG. 13B further includes an auger feature 1306 extending along the torque member 122. Among other things, the auger feature 1306 may aid in forcing fluids and materials proximally within the catheter body 104 and reduce clogging of the lumen of the catheter body 104. The auger feature 1306 may be a separate component surrounding the torque member 122 or may be integrally formed therewith.

[0158] 14A-14H show several alternative implementations of the tissue engaging portion 108 of the device according to the present disclosure. In FIG. 14A, the tissue engaging portion 108 includes an extension feature 1402 that extends beyond the end of the stator 114. Thus, the rotor distal tip 212 is a concave shaped structure that may beneficially prevent damage, particularly to blood vessels. The length of the extension feature 1402 may vary, but in certain exemplary implementations, the extension feature 1402 may be about 0.1 mm to about 100 mm, inclusive, about 1 mm to about 10 mm, inclusive, or about 2 mm. The extension feature 1402 may be formed by the distal sleeve 120 as shown. Alternatively, the extension feature 1402 may be formed by the catheter body 104 or may be a separate component coupled to the distal sleeve 120. While shown as being substantially cylindrical, in other implementations, the extension feature 1402 can terminate in a beveled or non-cylindrical shape. In other implementations, the extension feature 1402 can be expandable and can include a braided structure, laser cut parts, or similar structure that forms a cage around the rotor distal tip 212 and the stator distal portion 202 to provide a barrier to blood vessels or other tissue from becoming trapped in the pump assembly 110. In yet other implementations, the extension feature 1402 can be slidably or rotatably adjustable relative to the pump assembly 110. For example, an outer tube on the device 102 can be used to increase or decrease the amount that the distal face of the stator 114 recesses into the extension feature 1402. In still other implementations, the pump assembly 110 can be positioned anywhere along the length of the catheter body 104 such that the extension feature 1402 is simply the portion of the catheter body 104 that extends distally of the pump assembly 110. For example, the pump assembly 110 can be disposed within the catheter body 104 at an intermediate location along the length of the catheter body 104.

[0159] 14B illustrates another implementation of the device 102 that includes a funnel feature 1404 in the tissue engaging portion 108. Among other things, the funnel feature 1404 can aid in directing fluids and materials into the stator helical lumen 210, or alternatively can provide a suction cup feature for securing materials to the tissue engaging portion 108 during uptake.

[0160] In FIG. 14C, the rotor distal tip 212 is aligned with the funnel feature 140. 4 The rotor tip extension 1406 includes a rotor tip extension 1406 that extends forward into the tissue engaging portion 108. The rotor tip extension 1406 can assist the tissue engaging portion 108 in breaking up and incorporating material into the stator 114. The rotor tip extension 1406 can have a pointed shape as shown, or can be a variety of other shapes and configurations, such as an auger shape or a paddle shape. In some implementations, the rotor tip extension 1406 can remain within the extension feature 1402 or can extend beyond the distal end of the device 102. In some implementations, the rotor tip extension 1406 can be advanced or retracted by the user. For example, the rotor 116 can be advanced to extend the rotor tip extension 1406 during certain portions of the movement to break up clots and aid in the removal of wall-attached clots. During this movement, the handle assembly 106 can rotate the rotor 116 at a slower speed to prevent damage to the blood vessel. The rotor 116 can then be retracted so that the rotor distal tip 212 is flush with the end of the stator 114, minimizing the risk of vascular injury and allowing for faster motor rotational speeds.

[0161] In FIG. 14D, the rotor 116 has a helical lumen that runs the entire length of the rotor 116, through which an extension wire 1408 or similar elongated structure can be passed. The extension wire 1408 can be advanced from the end of the rotor 116 to form an advanceable rotor tip extension 1406 in the tissue engaging portion 108. The extension wire 1408 can include a predetermined shape, such as a curve or hook, configured to contact the vessel wall and disrupt the clot. The motor speed of the handle assembly 106 can be controlled depending on whether the extension wire 1408 is extended or not. In some implementations, the extension wire 1408 is not adjustable and is an integral part of the rotor 116. Alternatively, the extension wire 1408 can be used as a guide wire for guiding and delivering the device 102 to the target site.

[0162] 14E, the distal sleeve 120 includes a capped end 1410 that may beneficially prevent the tissue engaging portion 108 from engulfing a vessel wall, a valve, or other tissue not intended to be removed by the device 102. The distal sleeve 120 further includes a side cut 1412 that may direct material laterally into the tissue engaging portion 108. This may be particularly useful for material present in the luminal wall of a vessel. In this implementation, the side cut 1412 may be rotated circumferentially using a mechanism such as the catheter hub 124.

[0163] 14F, tissue engaging portion 108 includes a series of thrombus standoffs (e.g., standoffs 1414) that protrude from a distal end of stator 114. Gaps between adjacent thrombus standoffs may form one or more fluid inlets (e.g., fluid inlet 1416). The fluid inlets may allow low viscosity fluids, such as blood, to still enter pump assembly 110 while thicker material is being ingested. This may beneficially allow pump assembly 110 to ingest a mixture of blood and thrombus rather than just thrombus, which may improve performance of pump assembly 110.

[0164] In FIG. 14G, the tissue engaging portion 108 includes an infusion outlet 1204 at the stator 114. The infusion outlet 1204 can be used for infusion of a fluid, such as saline, which can provide improved performance of the pump assembly 110. The infused fluid can ensure that the pump assembly 110 has an optimal mix of low and high viscosity substances. Additionally, the infusion outlet 1204 can be oriented at an angle and used to spray thick materials at high speeds. This can beneficially break down thick materials, such as blood clots, prior to uptake by the pump assembly 110. The infusion outlet 1204 can be oriented at an angle or perpendicular to the end of the stator 114.

[0165] In FIG. 14H, the tissue engaging portion 108 is configured to include an injection outlet 120 extending through the rotor 116. 4 For example, the rotor 116 may have a lumen through its center and be connected to a hollow torque member, such as a tube or a torque coil. The injected fluid may aid in the performance of the pump assembly 110. Alternatively, the injected fluid may include a contrast agent, a fluid containing an active pharmaceutical ingredient (API), or a variety of other desired fluids.

[0166] Any combination of features or elements of the aforementioned implementations may be used alone or in combination with other implementations discussed herein. For example, rotor tip extension 1406 may be present in capped end 1410 to break up clots prior to ingestion into pump assembly 110, but with limited risk of vascular injury because rotor tip extension 1406 is contained within distal sleeve 120.

[0167] 15A and 15B show an implementation of the device 102 that includes a guidewire 1502. Typically, the device 102 is delivered through the patient's vasculature to the material to be removed. Certain catheterization techniques involve advancing the device over a guidewire or smaller catheter. In the illustrated implementation of FIGS. 15A and 15B, the guidewire 1502 is inserted through an insertion hole 1504 near the distal bend 206 of the distal sleeve 120. The insertion hole 1504 is generally sized to accommodate any suitable guidewire or microcatheter, but in at least certain implementations, the insertion hole 1504 can have a diameter of about 0.008 inches (0.2032 mm) to about 0.080 inches (2.032 mm), including about 0.008 inches (0.2032 mm) and about 0.080 inches (2.032 mm), or about 0.035 inches (0.889 mm). This allows the guidewire 1502 to be guided and positioned to the correct location within the patient's vasculature, and then the device 102 can be advanced over the guidewire 1502 to the desired site. The distal bend 206 allows the pump assembly 110 to be offset from the axis of the catheter body 104 and the guidewire 1502, so that the lumen of the pump assembly 110 does not have to completely clear the guidewire 1502 for the device 102 to track over the guidewire 1502. In some implementations, the catheter body 104 or distal sleeve 120 can be provided with additional exit holes to allow for quick exchange of the catheter. Once the guidewire 1502 is in place, the proximal end of the guidewire 1502 can be pulled through the insertion hole 1504 and out of the exit hole of the catheter body 104. In this manner, the guidewire 1502 does not need to be excessively long.

[0168] The present disclosure contemplates other methods of guiding the device 102 over the guidewire 1502. In some implementations, the rotor 116 can be removed from the stator 114 to allow the guidewire 1502 to pass through the lumen formed by the stator helical lumen 210. Once the target site is reached, the guidewire 1502 can be removed and the rotor 116 can be inserted into the stator 114. In other implementations, the rotor 116 and / or torque member 122 can include a hollow lumen through its center that allows for the passage of the guidewire. In such implementations, the proximal end of the guidewire 1502 can be inserted through the rotor 116 and torque member 122 to allow for the guidance of the device 102, after which the guidewire 1502 can be removed. In still other implementations, the guidewire 1502 can be loaded from the rear into the channel 1206, allowing the device 102 to follow on the guidewire 1502 as it spirals around the stator 114 within the distal sleeve 120.

[0169] 15C illustrates an implementation of the device 102 having multiple distal bends 206 that keep the axis of the stator 114 generally parallel to, but offset from, the axis of the catheter body 104 such that rotation of the catheter body 104 moves the tissue engaging portion 108 within the vessel. Such an implementation may allow for improved reach of the device 102 within large vessels without adversely orienting the tissue engaging portion 108 toward the vessel wall. Various other suitable bends and orientations of the stator 114 relative to the catheter body 104 are contemplated.

[0170] 16A-16C, an implementation of the device 102 having a visualization assembly 1602 at the distal end of the stator 114 is shown. The stator aperture 1606 can hold and / or orient the visualization assembly 1602 forward and can be offset from the stator helical lumen 210 to minimize the increase in catheter size of the device 102 having the visualization assembly 1602. Additionally, the visualization cable 1604 can be primarily straight as it travels along the length of the stator 114. In some implementations, the visualization assembly 1602 can be advanced and retracted or rotated relative to the stator 114 to change the viewpoint. The visualization assembly 1602 can be a camera, such as a CMOS or CCD imaging device, that provides visual feedback to the user of tissue structures at the distal end of the device 102 or of the clot 602 within the blood vessel 604. Alternatively, the visualization assembly 1602 can be an intravascular ultrasound (IVUS) imaging probe or catheter. Alternatively, the visualization assembly 1602 may be an optical coherence tomography (OCT) element. For example, the OCT element may be a guidewire that can be advanced from the tip of the device 102. The head of the visualization assembly 1602 may have a diameter of about 0.25 mm to about 3.0 mm, inclusive, about 0.5 mm to about 2.0 mm, inclusive, or about 1.0 mm. Alternatively, the head of the visualization assembly 1602 may be rectangular in shape.

[0171] The head of the visualization assembly 1602 can be connected to a visualization cable 1604 that runs inside the catheter body 104 and outside the patient. The visualization assembly 1602 can include a display, such as an LCD or LED screen, to provide visual feedback to the user. In some implementations, the user can view the display and advance or rotate the device 102 accordingly so that the distal end of the catheter is directed toward the desired tissue, such as a clot. The visual feedback can assist the user in navigating the tip of the device 102 away from or near vessel walls, venous valves, or other critical tissue structures. Additionally, visual feedback can indicate to the user if a vessel is collapsing due to negative pressure generated by the device 102 or too high aspiration flow.

[0172] In some implementations, the information provided by the visualization assembly 1602 may be used by software in or that may be executed by a computing device that communicates 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 blood vessel wall or a venous valve, the software may disable the device 102. In other implementations, the software may create an alarm or warning to the user in such a situation. In some implementations, the software may assist the user in being guided to the material by providing an audible or visual indicator. In other implementations, aspects of the device 102 may be automatically controlled, including, for example, the orientation of the distal end, the advancement of the distal end within the vessel, and the actuation of the pump assembly 110. In this manner, the visualization assembly 1602 may enable more automated aspects of the process by providing feedback to the software. In some implementations, the visualization assembly 1602 may provide feedback to the user regarding the location of the clot 602 within the vessel 604. For example, as a user moves the device 102 through a blood vessel 604, some clots 602 may be removed, but some clots 602 may remain, especially those attached to the wall. The visualization assembly 1602 can indicate to the user where to orient the tissue engaging portion 108 of the device, thereby providing more precise clot 602 removal. In some implementations, the visualization assembly 1602 can be advanced through the blood vessel 604 and then withdrawn, and a 2D or 3D representation of the blood vessel 604 can be shown to the user. In some implementations, the visualization assembly 1602 is not at the most distal end of the device 102, but rather along the side of the pump assembly 110 or within the catheter body 104.

[0173] 17A-17C, an embodiment of the device 102 is shown with a first visualization assembly 1602 and a second visualization assembly 1608 that are helically wrapped around the stator 114. By wrapping the first visualization cable 1604 and the second visualization cable 1610 around the stator 114, the overall size profile of the device 102 is not increased or is only minimally increased. In some implementations, the first visualization assembly 1602 is a camera and the second visualization assembly 1608 is an IVUS probe. In other implementations, both assemblies are cameras and can provide stereoscopic vision. In other implementations, the visualization assemblies can be oriented at different angles or provide different focal depths. The second visualization assembly 1608 does not necessarily have to be an imaging element. It can also be a light source for the first visualization assembly 1602 or a light source for external visualization through the patient's skin to allow direct visualization of the device 102. In other implementations, the second visualization assembly 1608 can be a tube for delivering a substance to aid in visualization to the distal end of the device. For example, the second visualization assembly 1608 can deliver clear saline or other clear fluid to the first visualization assembly 1602 and can provide positive pressure within the vessel to maintain vessel patency and prevent collapse. In still other implementations, the visualization assembly 1602 does not necessarily require a visualization cable 1604, but can include communication electronics for transmitting information to a display or software of the device 102 using Wi-Fi, Bluetooth, or any other suitable method.

[0174] 18A-18E, an implementation of device 102 is shown with a suction catheter 1802. The suction catheter 1802 is inside a blood vessel 604 that has material to be removed, in this case a blood clot 602 that is obstructing blood flow.

[0175] In Figure 18B, the suction catheter 1802 is advanced to the clot 602 and a suction source is connected to the catheter engaging the clot 602. As shown, the clot 602 has a plug portion 1804 that is within the suction catheter 1802. In this configuration, the vacuum level can be intentionally reduced to prevent entrapment of the clot 602. Alternatively, the situation shown in Figure 18B may result from the maximum vacuum level of the suction catheter 1802 being insufficient to completely entrap the clot 602.

[0176] In Fig. 18C, a version of the device 102 is inserted through a lumen of an 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 can be positioned against or proximal to the clot 602 and then actuated to uptake the clot 602 into the device 102, for example, using one or both of mechanical engagement with the clot 602 and suction. For example, in Fig. 18D, the clot 602 is partially uptaken by the device 102, and in Fig. 18E, the clot 602 has been completely removed from the blood vessel 604.

[0177] In some implementations, the device 102 can be a suction source for the suction catheter 1802 and can create a vacuum level to engage the clot 602 at the tip 1804 of the suction catheter. In such implementations, the pump assembly 110 can be positioned within the suction catheter 1802 at a distance of about 0 cm to about 100 cm, inclusive, about 0.1 cm to about 20 cm, inclusive, or about 0.5 cm away from the distal end. When the device 102 is actuated, suction is created within the suction catheter 1802 and the clot 602 is drawn into the suction catheter 1802 and moves to the tissue engaging portion 108. The clot 602 is then drawn into the pump assembly 110 and expelled into the lumen of the catheter body 104 or the lumen of the suction catheter 1802. The position of the pump assembly 110 can be adjusted as needed and in some implementations can be advanced beyond the end of the suction catheter 1802. In this manner, the user can adjust the position of the tissue engaging portion 108 depending on the type of clot, the stage of the procedure, or other reasons. In some implementations, the aspiration catheter 1802 fits snugly against the outer diameter of the device 102, forming a slidable outer tube around the outside of the device 102, allowing the catheter to engage the clot 602 and push the clot out of the tip of the device 102 to prevent or clear clogging of the pump assembly 110. In other implementations, the outer diameter of the device 102 is smaller than the lumen of the aspiration catheter 1802, allowing fluid to pass around the lumen of the device 102. In some implementations, the catheter body 104 is replaced by a control wire that can advance, retract, or rotate the pump assembly 110. Thus, the lumen of the aspiration catheter 1802 is maximized along its entire length, improving the deliverability of the device 102 through the aspiration catheter 1802.

[0178] 19A-19C, an implementation of the device 102 including a filter assembly is shown. In FIG. 19A, an alternative implementation of the handle assembly 106 is shown with a catheter hub 124, a throttle 418 and two handle shells 126A, 126B. The outlet tube 132 is connected to a collection assembly 112 having a filter assembly 712 and a collection cap 1902.

[0179] In FIG. 19B, the same device 102 is shown with the collection assembly 112 in a disassembled state. During operation, material removed using the device 102 enters the collection assembly 112 and is then filtered through the filter assembly 712. By doing so, solid or semi-solid material (e.g., thrombus material) is maintained in the front region of the collection chamber, and low viscosity material migrates to the rear region of the collection assembly 112 and is separated. In certain 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 in the collection assembly 112. In some implementations, the collection cap 1902 may further include a separate port for injection that allows a user to inject a fluid (e.g., saline) to better visualize material in the front region of the collection assembly 112. Additionally, the filtered blood may be stored for reintroduction into the patient if necessary. In some implementations, the collection assembly 112 may be integrated with the handle assembly 106 such that the outlet tube 134 may be omitted.

[0180] In FIG. 19C, the device 102 includes a series of filters for separating solid or semi-solid material from blood or other fluids, and a return tube 716 for reintroducing the fluid to the patient. In one specific implementation, the first filter assembly 712 can have a pore size of about 25 μm to about 1000 μm, inclusive, about 100 μm to about 400 μm, inclusive, or about 200 μm. In the same implementation, the second filter assembly 1904 can have a pore size of about 5 μm to about 100 μm, inclusive, or about 40 um. However, more generally, a variety of additional filters and filter pore sizes can be implemented. Also, the return tube 716 can return blood to the patient through a variety of access points, such as an introducer sheath, a separate access site, or the catheter body 104.

[0181] In Fig. 20, the device 102 is shown removing wall-adherent material 2002. In certain disease states, material adheres to the walls of a blood vessel 604. This material may include certain thrombotic diseases such as DVT, and may also include plaque found in peripheral and coronary artery disease. The wall-adherent material 2002 may be difficult to remove with a straight catheter body 104. In this implementation, the catheter body 104 includes a distal bend 206, which may be positioned using a rotation 2004 of the catheter body 104. Such a device 102 advantageously provides access to the entire circumference of the blood vessel 604.

[0182] As an alternative or supplement to the proximal filtration and separation system described above, the device 102 can also include a catheter filter 2006 along the catheter body 104. The catheter filter 2006 can include a series of holes in the catheter body 104 as shown, or can include a separate filter material. As blood and material is pumped out of the pump assembly 110 and through the catheter body 104, the blood is filtered from the material and allowed to re-enter the blood vessel 604 through the filtered blood return port 2008. This can advantageously reduce the amount of blood that is removed. The catheter filter 2006 can include a variety of pore sizes and lengths.

[0183] 21, an alternative implementation of the device 102 is shown in which the tissue engaging element 108 includes an expandable funnel 2010. The expandable funnel 2010 can be collapsed within the delivery sheath during introduction into the blood vessel 604. When deployed, the expandable funnel 2010 can open within the blood vessel 604 and partially or completely stop blood flow within the blood vessel 604. This can advantageously assist the tissue engaging element 108 in drawing material toward the pump assembly 110 and reduce the possibility of particles flowing downstream of the treatment site. In certain implementations, the expandable funnel 2010 can be constructed of braided wire or laser cut tubing and can further include a membrane such as silicone or PTFE that renders the expandable funnel 2010 impermeable or semi-impermeable.

[0184] FIG. 22 illustrates an alternative implementation of the device 102 in which the pump assembly 110 is disposed within the handle assembly 106. More specifically, the illustrated pump assembly 110 is a progressive cavity pump, including a stator 114 and a rotor 116, the operation of which is described herein. The handle assembly 106 has a motor 416 rotatably coupled to a motor adapter 412, which in turn is rotatably connected to the rotor 116. A manifold 128 fluidly connects the inlet of the pump assembly 110 to the catheter body 104, such that operation of the pump assembly 110 draws fluid from the catheter body 104. The distal tip of the catheter body 104 is open, so that it functions similarly to a conventional suction catheter. Such an implementation has the advantages of not requiring a separate device and the vacuum being generated closer to the catheter tip, resulting in less line loss and easier dynamic control by the user. In the illustrated implementation, an outlet tube 132 drains the fluid to a waste container, and an electrical cable 134 provides power to the device 102. In other implementations, the waste container may be integrated into the handle assembly 106, similar to the battery, so that no additional cables or lines extend from the device 102. In some implementations, the distal tip of the catheter body 104 may still include an additional pump assembly 110, as described in other implementations. These two pump assemblies 110 may be rotatably connected via a torque member 122 or may rotate independently. In other implementations, the distal tip of the catheter body 104 may include other crushing or tissue disrupting elements, such as a screw, an auger, or a 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.

[0185] The following is a discussion of various alternative or supplemental features that may be included in implementations of the present disclosure. Unless otherwise noted, it should be assumed that any of the alternatives discussed in the following sections may be incorporated or applied to any embodiment included in or otherwise within the scope of the present disclosure.

[0186] In some implementations, the rotor 116 can have various coatings or textures along its rotor helix 214. The coatings can be lubricious coatings, such as hydrophilic or hydrophobic coatings or metal plating. Alternatively, the outer surface can be textured or coated to provide additional friction to draw blood clots into the stator 114. In yet other implementations, the rotor helix 214 can include an elastomeric coating on its outer surface, which can be a sealing member, and thus the stator 114 can be constructed of a hard material, such as a thermoplastic or metal, with low compressibility. In such implementations, the seal is achieved primarily by compression of a portion of the rotor 116 rather than the stator 114. In still other implementations, neither the rotor 116 nor the stator 114 are elastic materials, and no seal is achieved during device operation. For example, a clearance gap may exist between the rotor 116 and the stator 114, creating an unsealed cavity, but when the rotor 116 is rotating, the pump assembly 110 still operates like a pump, but with some slippage due to the clearance gap. This slippage advantageously prevents efficient evacuation of low viscosity fluids such as blood, but still allows for pumping of thicker material such as clots. This may beneficially reduce blood loss during clot extraction. Such clearance gaps are sometimes implemented in progressive cavity pumps to allow for manufacturing tolerances in the components.

[0187] In some implementations, the stator 114 has a rounded or tapered distal edge rather than a sharp shape as shown in many of the figures. A rounded distal edge can prevent injury to the vessel by providing a smoother surface that contacts the vessel wall.

[0188] In some implementations, the pump assembly 110 does not pump fluid. For example, the stator helix 210 or rotor helix 214 may be comprised of a small portion, such as one-half, of the total pitch cavity. In such implementations, a completely closed cavity 224 is not achieved between the stator helix lumen 210 and the rotor helix 214 because there is a segment of rotation of the rotor 116 where the lumen of the catheter body 104 is in fluid communication with the fluid at the distal end of the device 102. A separate suction source can be applied to the device 102, for example through the outlet tube 132, to draw fluid and matter into the catheter body 104. The rotor 116 can then be rotated to assist in the capture of material that may have become clogged. In this manner, the tissue engaging portion 108, including the rotating rotor 116, works in conjunction with a separate suction source, including a pump, to remove fluid and matter. The suction source may be a pump in the handle assembly 106, such as a piston pump, a peristaltic pump, or other type of pump. The rotor 116 aids in suction by breaking up the clot and pushing clot fragments into the catheter body 104. In some implementations, the device 102 does not include a stator 114, and instead the rotor 116 may rotate within the catheter body 104.

[0189] In some implementations, the device 102 can include one or more pump assemblies 110. For example, the catheter body 104 can have one or more pump assemblies 110 along its length to further aid in the removal of material from the patient or to prevent clogging of the catheter body 104. The multiple pump assemblies 110 can be rotationally connected by one or more torque members 122, such as a daisy chain. In other implementations, the pump assemblies 110 can rotate at different speeds and timings. The pump assemblies 110 can all have the same pump parameters, such as pitch and diameter, or they can be different. In some implementations, there can be a single or multiple pump assemblies 110 along the entire length of the catheter body 104. Additionally, there can be multiple inlet or outlet holes in the catheter body 104. Some of the pump assemblies 110 are located inside the patient's body, while others are located outside the patient's body during intended use.

[0190] In some implementations, the distal bend 206 may be configured in various configurations. In some implementations, the distal bend may be at a fixed angle, while in other configurations, it may be flexible and deformable by tissue structure or by the user prior to operation. In other implementations, the distal bend 206 may be manipulable. For example, the handle assembly 106 may include an interface that allows the user to actively adjust the angle of the distal bend 206. This may be accomplished using control wires or any other suitable mechanism. In some implementations, the rotation of the catheter hub 124 and the catheter body 104 may be performed automatically by the handle assembly 106. For example, the rotation of the catheter hub 124 may be driven by a separate motor at a desired speed or in conjunction with the main motor 416 that drives the pump assembly. In still other implementations, the rotation of the catheter hub 124 may be driven by the motor 416, possibly via a gear reduction mechanism that rotates the tip of the device once for every predetermined number of rotations of the rotor 116. A user may provide input and control over the motor rotation of the catheter hub 124. Rotation of the catheter hub 124 may help ensure that the distal bend 206 guides the tissue engaging portion 108 along the lumen of the blood vessel 604.

[0191] In some implementations, the controller 136 can apply different rotation profiles to the drive system 130 and the motor 416. For example, in one implementation of the rotation profile, the motor speed is proportional to the user input of the throttle 418. The further the user presses the throttle 418, the faster the motor 416 rotates. In other implementations of the rotation profile, the throttle 418 can switch between certain stepped motor 416 speeds. For example, a slow motor 416 speed can be useful for low flow rates of blood and capturing acute soft clots 602. Then, when a thick clot 602 is encountered, feedback can be provided to the user, as described elsewhere, indicating that the user can press the throttle 418 further to reach a faster stepped speed optimized for capturing the clot 602. In other implementations of the rotation profile, the controller 136 can include additional profiles, such as a pulse rotation, in which the pump is rotated at a higher speed for certain delimited periods of time with pauses in between. For example, the controller 136 may be configured to rotate the motor 416 at a first speed for a first fixed number of revolutions, then at a second fixed speed for a second fixed number of revolutions, or alternatively, to stop rotation for a fixed period of time. The controller 136 may execute this pattern repeatedly. In yet other implementations of rotational profiles, the motor profile of the controller 136 may include cycles of high speed pumping with a short period of reverse rotation to expel a small amount of fluid. These profiles may improve clot disruption and entrapment while mixing the clot with the blood. In some implementations, a pulse profile may create a pulsed vacuum at the distal end of the catheter to aid in entrapment of the clot. In some implementations of rotational profiles, the user may control the controller 13 6 to adjust the rotation profile. A variety of motor rotation profiles are contemplated.

[0192] In some implementations, the handle assembly 106 can be split into a disposable assembly and a reusable assembly. For example, the catheter body 104 and catheter hub 124 can be disposable along with all distal elements and the collection assembly 112, while the majority of the handle assembly 106 can be a durable assembly. In this manner, a user can connect the disposable and reusable portions, perform an operation, and then discard the catheter assembly while cleaning and reusing the handle assembly 106. Various other configurations are contemplated.

[0193] In some implementations, the controller 136 can adjust the speed of the motor 416 depending on the torque required to rotate the rotor 116. For example, if the pump assembly 110 takes in a fluid, it is likely to require a lower torque to rotate than if the tissue engaging portion 108 takes in a viscous material such as a blood clot. One estimate of the applied torque is the current the motor 416 uses to rotate at a given speed. The controller 136 can define different profiles depending on the current of the motor 416, where the profile provides a relationship between torque and rotation speed. Thus, as the torque applied by the motor 416 changes, the controller 136 can adjust the rotation speed of the rotor 116 based on the profile.

[0194] For example, when the motor 416 only takes in blood, it can rotate at a slower speed, thus reducing blood loss. In some implementations, the baseline torque can be set individually for each device by rotating the motor in air, water, saline, or blood. For example, at the time of manufacture, the reference torque can be stored in the controller 136 or alternatively set during an initialization or priming step performed by the user. This baseline can then be used to determine if the pump assembly 110 is taking in a clot or engaging other vasculature. The speed of the motor 416 can be adjusted accordingly. In yet other implementations, the baseline can be dynamically set by the controller based on sampling of previously recorded measurements such as motor current. Other methods of measuring the torque required to rotate the rotor are contemplated, such as motor voltage, torque gauge, or any other suitable feedback. As the tissue engaging portion 108 engages and begins to take in a clot, the current of the motor 416 increases and the controller 136 can increase the speed of the motor 416 to more efficiently take in the clot. As an example, a reference torque may be set before beginning the procedure and may be about 0.1 mN·m to about 200 mN·m, inclusive, or about 10 mN·m. The controller 136 may then determine that a clot has been engaged and alter the speed of the motor 416 if the torque increases by about 5% to about 80%, inclusive, or about 20%. Different profiles are contemplated for different conditions. In another implementation, the same method may be used to determine if a blood vessel or other fragile structure is engaged with the tissue engaging portion 108, and the controller 136 may stop or even reverse the drive system 130 completely. Feedback may be provided to the user in a variety of ways. For example, an audio tone may be adjusted in volume or frequency to alert the user that the pump assembly 110 is taking in blood or the tissue engaging portion 108 is in contact with a clot. A variety of user interfaces may be used, such as light, sound, vibration, etc.

[0195] In some implementations, the device 102 can be connected to a user interface, such as a smartphone, tablet, computer, or controller box. The connection to the device 102 can be made using Bluetooth, Wi-Fi, Zigbee, a wired connection, or any other suitable method. A user can make adjustments to the controller 136 through the user interface, which can change the response of the device 102 to different inputs, such as the throttle 418. In some implementations, the device 102 can be controlled by other user inputs. For example, a foot pedal can be used as the throttle 418 rather than a trigger.

[0196] In some implementations, the device 102 can record data from a given procedure and store the data in the controller 136 or transmit the data via a wireless or wired connection to another recording device. The data can include information such as the amount of blood removed, a torque profile indicative of clot engagement, time of use, or any other information generated during the procedure. The user can review the data or save it for future reference.

[0197] In some implementations, the filter assembly 712 may be located within the handle assembly 106. In such implementations, blood drained from the manifold 128 may be fed directly to the filter assembly 712, which separates clot material from the blood in the handle assembly 106. The return tube 716 may feed the filtered blood through the catheter body 104 and out of the side holes. In this manner, the device 102 may not require external tubing, which may simplify setup and operation. The filtered clots may be contained within the collection assembly 112 within the handle assembly 106. In some implementations, the catheter body 104 includes multiple openings proximal to the pump assembly 110, allowing blood to be returned to the patient while thrombus is filtered and retained within the catheter body 104. In this implementation, the catheter body 104 itself or components within the catheter body 104 may function as the filter assembly 712.

[0198] In some implementations, the pump assembly may be operated in reverse to that described in FIGS. 3A-3F to expel material from the pump assembly 110. For example, if the pump assembly 110 or tissue engaging portion 108 becomes clogged, the controller 136 may rotate the drive system 130 counterclockwise, thus expelling material from the pump assembly 110. This may beneficially unclog the pump assembly 110 and allow the user to resume removing material. In some implementations, this may be done at a certain interval of operation or at the end of a pump run to automatically unclog the device without input from the user. In other implementations, reversing the pump assembly 110 may be used to disengage a vessel or valve or other tissue that is not intended to be engaged by the tissue engaging portion 108.

[0199] In some implementations, the hardness of the material of the stator 114 may be selected based on the material being removed. For example, when removing an acute fresh clot, a user may select a device 102 with a stator 114 constructed of a more elastic material, such as silicone Shore 35A. When removing a thicker chronic clot, a user may select a device 102 with a stator 114 constructed of nylon or a similar hard plastic.

[0200] In some implementations, the device 102 may be primed with a fluid prior to use. For example, a user may place the tip of the device 102 into a container of saline and actuate the device 102 to pump saline into the catheter body 104. Alternatively, a user may prime the pump assembly 110 with a grease or lubricant prior to clinical use.

[0201] Experimental Results A prototype device was fabricated according to the implementation and design shown in FIG. 1A. The stator 114 was constructed of elastic Shore 80A material, and the other materials were 3D printed with rigid plastic. The catheter body 104 was an HDPE extrusion, and a 24 volt brushless DC motor 416 was used for the drive system 130. Tests were conducted to evaluate the ability to extract a clot from a simulated blood vessel. An artificial clot simulant weighing 6.3 grams was placed between two transparent plates containing a cylindrical cutout. The model was pressurized with saline from a gravity-fed reservoir approximately 12 cm in height. The device 102 was inserted into the model through the hemostatic valve. The pump assembly 110 was actuated by the throttle 418 and motor 416. As the rotor 116 rotated, fluid was pumped through the device and out of the outlet tube. The tissue-engaging portion 108 was then advanced towards the clot simulant. The tissue engaging portion 108 and pump assembly 110 efficiently removed the clot simulant in 19 seconds with a measured volume of expelled fluid of only 52 ml. This experimental result indicates that this implementation of the device 102 functioned as intended.

[0202] Although much has been described regarding thrombectomy procedures in which clots and thrombi are removed, it is not intended to limit the scope or use of device 102 to such procedures. For the avoidance of doubt, it is believed that the terms clot and thrombus can be used interchangeably with any material to be removed. Device 102 can have a variety of shapes and sizes and can serve as a platform for any type of thrombectomy, embolectomy, or foreign body, stone, or tissue removal in any part of the body or vessel, including, but 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 fluid during surgery of the ventricular system or cerebral, removal of liquid embolic agents, peripheral arterial thromboembolism including clot-filled hemodialysis grafts, mesenteric and peripheral vascular trees, peripheral arterial thromboembolism, critical limb ischemia (CLI), chronic total occlusion (CTO), and stone removal. The device 102 may also be used in debulking procedures to remove tumors and other cancerous material.

[0203] In various other suitable applications, such a device 102 can be used for removal of tissue, foreign bodies, stones, or other objects in tubular enclosed spaces, or even in non-tubular or non-enclosed spaces. In some implementations, the device 102 may be used for removal of tissue during small incision laparoscopic procedures, including biopsies or removal of malignant tissue.

[0204] The names and labels applied to the various components or parts should not be construed as limiting the scope of the invented devices or methods.

[0205] Although various method and device implementations are described in detail herein with reference to specific versions, it should be understood that other versions, implementations, methods of use, and combinations thereof are possible, and therefore the spirit and scope of the appended claims should not be limited to the description of the implementations contained herein.

[0206] Exemplary Aspects of the Disclosure Illustrative examples of the present disclosure include, but are not limited to, the following:

[0207] Aspect 1: A device, comprising: a catheter, the catheter including a lumen extending therethrough; and a progressive cavity pump in a distal portion of the catheter. And, the progressive cavity pump is in communication with each of the lumen and an external environment surrounding the distal portion of the catheter, and is operable to transport a substance from the external environment into the lumen of the catheter. a progressive cavity pump; device.

[0208] Aspect 2: The device of Aspect 1, further comprising a container in fluid communication with the proximal end of the lumen, the container configured to provide or receive a substance to be transported through the lumen.

[0209] Aspect 3: A device as described in Aspect 1, wherein the progressive cavity pump is coupled to and extends from a distal end of the catheter.

[0210] Aspect 4: A device as described in Aspect 1, wherein the progressive cavity pump is at least partially disposed within the lumen at the distal end of the catheter.

[0211] Aspect 5: The device of Aspect 1, wherein the progressive cavity pump includes a stator formed at least in part from an elastic material.

[0212] Aspect 6: The device of Aspect 1, wherein the progressive cavity pump includes a stator defining a helical stator bore and a helical rotor extending through the helical stator bore, the pitch of the helical stator bore being approximately twice the pitch of the helical rotor.

[0213] Aspect 7: The device of Aspect 1, wherein the progressive cavity pump includes a stator and a rotor arranged to form a cavity between the stator and the rotor, the cavity being fluidly sealed by compression between the stator and the rotor.

[0214] Aspect 8: The device of Aspect 1, wherein the progressive cavity pump includes a stator and a rotor arranged to form a cavity between the stator and the rotor, the cavity not being sealed by a clearance gap between the stator and the rotor.

[0215] Aspect 9: The device of Aspect 1, wherein the progressive cavity pump includes a rotor, and the device further includes a torque member extending through the lumen and coupled to the rotor, the torque member operable to transmit torque applied to a proximal end of the torque member to the rotor.

[0216] Aspect 10: The device of Aspect 1, wherein the progressive cavity pump includes a rotor, the device further including a motor coupled to the rotor and operable to drive the rotor.

[0217] Aspect 11: A device described in Aspect 1, wherein the distal end of the catheter comprises an angled tip.

[0218] Aspect 12: The device described in Aspect 1, wherein the distal portion has an outer diameter of about 6 French (2.01 millimeters) to about 20 French (6.68 millimeters), including 6 French (2.01 millimeters) and 20 French (6.68 millimeters).

[0219] Aspect 13: A device as described in Aspect 1, wherein the progressive cavity pump forms a seal between the internal cavity and the external environment.

[0220] Aspect 14: The method of aspect 1 further comprising a handle assembly coupled to a proximal end of the catheter, the handle assembly including a drive system for controlling the progressive cavity pump. Described in device.

[0221] Aspect 15: The method further comprises: a distal pump assembly coupled to a distal end of the catheter and including the progressive cavity pump. 、 The distal pump assembly includes a sleeve coupled to a stator of the progressive cavity pump and fixing rotation of the stator of the progressive cavity pump relative to the sleeve. Described in device.

[0222] Aspect 16: The device described in Aspect 1, further comprising a distal pump assembly disposed within the distal end of the catheter and comprising the progressive cavity pump.

[0223] Aspect 17: The device described in Aspect 1, further comprising a distal pump assembly coupled to a distal end of the catheter and including the progressive cavity pump, the progressive cavity pump including a stator and a rotor, the distal pump assembly including a positioning element disposed at a proximal end of the stator, the positioning element configured to maintain an axial relationship between the stator and the rotor during operation of the distal pump assembly.

[0224] Aspect 18: The device of Aspect 1, wherein the progressive cavity pump includes a rotor coupled to a drive system, the drive system configured to rotate the rotor at multiple rotational speeds.

[0225] Aspect 19: The device of Aspect 18, wherein the drive system is configured to change between the multiple rotational speeds depending on the torque applied by the drive system.

[0226] Aspect 20: The device of aspect 19, wherein the torque applied by the drive system is estimated based on current drawn by a motor of the drive system.

[0227] Aspect 21: The device of Aspect 19, wherein the drive system includes a profile defining one or more relationships between torque and rotational speed, and the drive system is configured to change between the multiple rotational speeds in response to the torque based on the profile.

[0228] Aspect 22: The device of Aspect 1, further comprising a collection assembly in communication with the lumen of the catheter and configured to receive material taken up by the progressive cavity pump, the collection assembly including a filtration system.

[0229] Aspect 23: The device of aspect 22, further comprising a return tube in communication with the collection assembly configured to receive material not retained by the filter.

[0230] Aspect 24: The device described in Aspect 1, wherein the progressive cavity pump includes a stator defining a stator cavity and a stator opening separate from the stator cavity, the device further comprising a visualization assembly supported within the stator opening.

[0231] Aspect 25: A device as described in Aspect 24, wherein the visualization assembly includes a cable and the stator defines a channel through which the cable extends.

[0232] Aspect 26: The device described in Aspect 25, wherein the channel extends spirally around the stator.

[0233] Aspect 27: The progressive cavity pump is a device as described in Aspect 1, comprising a stator defining a stator cavity and a channel separate from the stator cavity.

[0234] Aspect 28: The device of Aspect 1, wherein the progressive cavity pump includes a stator defining a stator cavity and a channel extending along an outer surface of the stator, the channel being separate from the stator cavity.

[0235] Aspect 29: The device of Aspect 1, wherein the progressive cavity pump includes a stator defining a stator cavity and a channel separate from the stator cavity and extending spirally along an outer surface of the stator.

[0236] Aspect 30: The device of Aspect 1, wherein the progressive cavity pump includes a stator defining a stator cavity and a plurality of channels separate from the stator cavity.

[0237] Aspect 31: The device of Aspect 1, further comprising a port extending between the internal volume of the device and the external environment and positioned proximal to the progressive cavity pump.

[0238] Aspect 32: The device described in Aspect 31, wherein the port is sized to receive at least one of a guidewire and a microcatheter.

[0239] Aspect 33: A method, comprising: disposing a material removal device within a physiological or body 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, the progressive cavity pump in communication with each of the catheter lumen and the physiological or body cavity of the patient. Material removal device and actuating the progressive cavity pump to draw a substance from the physiological or body lumen into the catheter lumen.

[0240] Aspect 34: The patient outside the bodyPlaced in A container comprising: 34. The method of embodiment 33, further comprising transporting the substance through the catheter lumen to a container in communication with a proximal end of the catheter lumen.

[0241] Aspects 35-1 The method of claim 33, wherein the progressive cavity pump includes a stator and a rotor arranged to form a cavity between the stator and the rotor, and when the progressive cavity pump is operated, the material is drawn into the cavity.

[0242] Aspects 35-2 The method according to aspect 33, wherein the substance removal device is a device described in any one of aspects 1 to 32.

[0243] Aspect 36: The method of aspect 33, wherein the material removal device is the device of aspect 18, and the method further includes rotating the rotor at a first speed of the plurality of rotational speeds; obtaining a torque applied to the rotor by the drive system while rotating the rotor at the 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.

[0244] Aspect 36: The method of aspect 33, wherein the material removal device is the device of aspect 19, and the method further includes rotating the rotor at a first speed of the plurality of rotational speeds; obtaining a torque applied to the rotor by the drive system while rotating the rotor at the first speed; and in response to the torque, changing the rotational speed of the rotor to a second rotational speed of the plurality of rotational speeds according to the profile.

[0245] Aspect 37: The method of aspect 33, further comprising transferring the material to a collection assembly in communication with the catheter lumen and outside the patient's body.

[0246] Aspect 38: The method of aspect 37, further comprising filtering unwanted material using a filter assembly disposed within or in-line with the collection assembly.

[0247] Aspect 39: The method of aspect 37, further comprising returning at least a portion of the captured material to the patient through a return tube communicating with the collection assembly.

[0248] Aspect 40: The method of aspect 33, wherein the progressive cavity pump includes a stator defining a stator cavity and a channel separate from the stator cavity, the method further including at least one of injecting liquid or applying suction through the channel.

[0249] Aspect 41: The method of aspect 33, wherein positioning the material removal device includes positioning the material removal device within a second catheter positioned within the physiological lumen or body cavity of the patient.

[0250] Aspect 42: The method of aspect 41, wherein the substance is disposed within the lumen of the second catheter, and taking up the substance from the physiological lumen or body cavity into the catheter lumen includes taking up the substance from within the lumen of the second catheter.

[0251] Aspect 43: The method of aspect 33, wherein positioning the material removal device comprises translating the material removal device along a guidewire.

[0252] Aspect 44: The method of aspect 43, wherein the material removal device is a device described in aspect 31, and the guidewire extends through the port while the material removal device translates along the guidewire.

Claims

1. A device, comprising: a catheter including a lumen extending therethrough; a progressive cavity pump in a distal portion of the catheter, the progressive cavity pump in communication with each of the lumen and an external environment surrounding the distal portion of the catheter, the progressive cavity pump operable to transport a substance from the external environment into the lumen of the catheter; A device comprising:

2. The device of claim 1 , further comprising a container in fluid communication with a proximal end of the lumen, the container configured to supply or receive a substance to be transported through the lumen.

3. The device of claim 1 , wherein the progressive cavity pump is coupled to and extends from a distal end of the catheter.

4. The device 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 device of claim 1 , wherein the progressive cavity pump includes a stator formed at least in part from a resilient material.

6. 2. The device of claim 1, wherein the progressive cavity pump includes a stator defining a helical stator bore and a helical rotor extending through the helical stator bore, the pitch of the helical stator bore being approximately twice the pitch of the helical rotor.

7. 10. The device of claim 1, wherein the progressive cavity pump includes a stator and a rotor arranged to form a cavity between the stator and the rotor, the cavity being fluidly sealed by compression between the stator and the rotor.

8. 2. The device of claim 1, wherein the progressive cavity pump includes a stator and a rotor arranged to form a cavity between the stator and the rotor, the cavity being unsealed by a clearance gap between the stator and the rotor.

9. 10. The device of claim 1, wherein the progressive cavity pump includes a rotor, the device further comprising a torque member extending through the lumen and coupled to the rotor, the torque member operable to transmit torque applied to a proximal end of the torque member to the rotor.

10. The device of claim 1 , wherein the progressive cavity pump includes a rotor, the device further comprising: a motor coupled to the rotor and operable to drive the rotor.

11. The device of claim 1 , wherein the distal end of the catheter includes an angled tip.

12. 10. The device of claim 1, wherein the distal portion has an outer diameter of about 6 French (2.01 mm) to about 20 French (6.68 mm), inclusive.

13. The device of claim 1 , wherein the progressive cavity pump forms a seal between the internal cavity and the external environment.

14. The device of claim 1 , further comprising a handle assembly coupled to a proximal end of the catheter, the handle assembly including a drive system for controlling the progressive cavity pump.

15. 2. The device of claim 1, further comprising a distal pump assembly coupled to a distal end of the catheter and including the progressive cavity pump, the distal pump assembly including a sleeve coupled to a stator of the progressive cavity pump and fixing rotation of the stator of the progressive cavity pump relative to the sleeve.

16. The device of claim 1 , further comprising a distal pump assembly disposed within a distal end of the catheter and including the progressive cavity pump.

17. 2. The device of claim 1, further comprising: a distal pump assembly coupled to a distal end of the catheter and including a progressive cavity pump, the progressive cavity pump including a stator and a rotor, the distal pump assembly including a positioning element disposed at a proximal end of the stator, the positioning element configured to maintain an axial relationship between the stator and the rotor during operation of the distal pump assembly.

18. 1. A method comprising:

2. Placing a material removal device within a physiological or body lumen of a patient, the material removal device comprising: a catheter including a catheter lumen extending therethrough; and a progressive cavity pump in a distal portion of the catheter, the progressive cavity pump in fluid communication with each of the catheter lumen and the physiological or body lumen of the patient. deploying a material removal device; and actuating the progressive cavity pump to draw a substance from the physiological or body cavity into the catheter lumen.

19. 20. The method of claim 18, further comprising transporting the substance through the catheter lumen to a container located outside the patient's body, the container being in communication with a proximal end of the catheter lumen.

20. 20. The method of claim 18, wherein the progressive cavity pump includes a stator and a rotor arranged to form a cavity between the stator and the rotor, and wherein actuation of the progressive cavity pump draws the material into the cavity.

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