Patent Application
20250152193
All publications and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.
The present technology generally relates to medical devices and, in particular, to systems including aspiration and fluid delivery mechanisms and associated methods for removing a thrombus from a mammalian blood vessel.
Thrombotic material may lead to a blockage in fluid flow within the vasculature of a mammal. Such blockages may occur in varied regions within the body, such as within the pulmonary system, peripheral vasculature, deep vasculature, or brain. Pulmonary embolisms typically arise when a thrombus originating from another part of the body (e.g., a vein in the pelvis or leg) becomes dislodged and travels to the lungs. Anticoagulation therapy is the current standard of care for treating pulmonary embolisms, but may not be effective in some patients.
Additionally, conventional devices for removing thrombotic material may not be capable of navigating the tortuous vascular anatomy, may not be effective in removing thrombotic material, and/or may lack the ability to provide sensor data or other feedback to the clinician during the thrombectomy procedure. Existing thrombectomy devices operate based on simple aspiration which works sufficiently for certain clots but is largely ineffective for difficult, organized clots. Many patients presenting with deep clots in difficult to reach anatomical locations and/or deep vein thrombus (DVT) or PE are left untreated as long as the risk of limb ischemia is low.
In more urgent cases, they are treated with catheter-directed thrombolysis or lytic therapy to break up a clot over the course of many hours or days.
More recently other tools like clot retrievers have been developed to treat DVT and pulmonary embolism (PE). Clot retrievers typically include a structure that is deployed from a distal end of the catheter within the vessel to capture thrombus and then withdrawn back into the distal end of the catheter for thrombus removal. The structure can include stent-like structures, expandable capture baskets, or capture structures that include passive capture features like rakes, barbs, or prongs to engage the clot. These tools are not being widely adopted because of their limited effectiveness, high mortality rates, and additional costs versus aspiration or the standard of care. Additionally, advancing the capture structure distally from the end of the catheter poses additional challenges including limited visualization of the clot relative to the capture device and the risk of damaging vessel walls with the passive capture structures. Other recent developments focus on slicing or macerating the clot, but these mechanisms are designed to reduce the risk of the catheter clogging and do not address the problem of tough, large, organized clots. There remains the need for a device to address these and other problems with existing venous thrombectomy including, but not limited to, a fast, easy-to-use, and effective device for removing a variety of clot morphologies in difficult to reach anatomical locations.
The novel features of the invention are set forth with particularity in the claims that follow. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings of which:
A thrombus removal device is provided, comprising: an elongate catheter having an aspiration lumen; an aspiration source coupled to the aspiration lumen; an expandable funnel coupled to the aspiration lumen and the elongate catheter; at least one mechanical engagement feature disposed within the expandable funnel, wherein the at least one mechanical engagement feature is actuatable to move the at least one mechanical engagement feature within the expandable funnel.
In one aspect, the at least one mechanical engagement feature is actuatable to move the at least one mechanical engagement within the expandable funnel towards the aspiration lumen.
In one aspect, the at least one mechanical engagement feature is actuatable to move the at least one mechanical engagement feature generally radially within the expandable funnel across at least a portion of the expandable funnel.
In one aspect, the at least one mechanical engagement feature comprises a cutting portion.
In one aspect, the at least one mechanical engagement feature comprises a blunted tip.
In one aspect, the device further includes a fluid source; a fluid lumen positioned in the elongate catheter and in fluid communication with the fluid source; a jet orifice positioned near or within the expandable funnel and in fluid communication with the fluid lumen, the jet orifice being configured to provide a fluid stream within the aspiration lumen or within the expandable funnel.
In one aspect, the at least one mechanical engagement feature is actuatable to move the at least one mechanical engagement within the expandable funnel towards the fluid stream.
In one aspect, at least one mechanical engagement feature is in fluid communication with the fluid lumen and is further configured to provide a second fluid stream within the aspiration lumen or within the expandable funnel.
In one aspect, the expandable funnel comprises a funnel frame configured to self-expand the funnel to a fully expanded configuration.
In one aspect, the expandable funnel further comprises a compliant material disposed over at least a portion of the funnel frame.
In one aspect, the device further includes an actuatable frame mechanically coupled to the at least one mechanical engagement feature, the actuatable frame having at least a portion positioned proximally from the funnel frame.
In one aspect, the device further includes a sheath configured to slide axially over the elongate catheter, wherein relative movement therebetween to place the sheath into contact with the actuatable frame moves the at least one mechanical engagement feature within the expandable funnel.
In one aspect, placing the sheath into contact with the actuatable frame does not collapse or reduce a diameter of the expandable funnel.
In one aspect, the at least one mechanical engagement feature is coupled to the funnel frame at a hinge.
In one aspect, a distal portion of the at least one mechanical engagement feature extends from the hinge into the expandable funnel and a proximal portion of the at least one mechanical engagement feature extends outside of the funnel.
In one aspect, the device further includes a sheath configured to slide axially over the elongate catheter, wherein relative movement therebetween to place the sheath into contact with the proximal portion of the at least one mechanical engagement feature moves the distal portion of the at least one mechanical engagement feature about the hinge within the expandable funnel.
In one aspect, the device further includes a sheath configured to rotate around the elongate catheter, wherein rotating the sheath into contact with the proximal portion of the at least one mechanical engagement feature moves the distal portion of the at least one mechanical engagement feature about the hinge within the expandable funnel.
In one aspect, the at least one mechanical engagement feature includes a pair of mechanical engagement features configured to collide at a pinch point when actuated.
In one aspect, the at least one mechanical engagement feature includes a pair of mechanical engagement features configured to create a shearing action when actuated.
In one aspect, the at least one mechanical engagement feature comprises a plurality of mechanical engagement features that are collectively actuated as a group.
In one aspect, the at least one mechanical engagement feature comprises a plurality of mechanical engagement features that are individually and independently actuated.
In one aspect, the at least one mechanical engagement feature comprises a first group of mechanical engagement features that can be actuated independently from a second group of mechanical engagement features.
In one aspect, the at least one mechanical engagement feature comprises a first mechanical engagement feature disposed within the expandable funnel at a first axial position and a second mechanical engagement feature disposed within the expandable funnel at a second axial position distal to the first axial position.
In one aspect, the at least one mechanical engagement feature comprises a plurality of mechanical engagement features configured to move towards a central point within the expandable funnel.
In one aspect, the at least one mechanical engagement feature includes an at-rest configuration in which the at least one mechanical engagement feature is positioned adjacent to or abutting against the compliant material.
In one aspect, the compliant material further comprises at least one pocket corresponding to each of the at least one mechanical engagement features, wherein the at least one mechanical engagement feature includes an at-rest configuration in which the at least one mechanical engagement feature is positioned within its corresponding pocket within the compliant material.
In one aspect, the compliant material further comprises at least one slit corresponding to each of the at least one mechanical engagement features, wherein the at least one mechanical engagement feature includes an at-rest configuration in which the at least one mechanical engagement feature covered by the compliant material and an actuated configuration in which the at least one mechanical engagement feature passes through its corresponding slit to move into the expandable funnel.
In one aspect, actuation of the at least one mechanical engagement feature causes the at least one mechanical engagement feature to pivot within the expandable funnel.
In one aspect, the elongate catheter extends along a longitudinal axis, and further wherein the expandable funnel and at least a portion of the at least one mechanical engagement feature are configured to maintain respective axial positions with respect to the longitudinal axis during actuation of the at least one mechanical engagement feature.
In one aspect, the at least one mechanical feature does not extend beyond a distal end of the expandable funnel.
A medical device is provided, comprising: an elongate catheter; an expandable member positioned at a distal end of the elongate catheter; at least one mechanical engagement feature disposed within the expandable member, wherein the at least one mechanical engagement feature is actuatable to move the at least one mechanical engagement feature within the expandable funnel.
In one aspect, the at least one mechanical engagement feature is actuatable to move the at least one mechanical engagement within the expandable member.
In one aspect, the at least one mechanical engagement feature is actuatable to move the at least one mechanical engagement feature generally radially within the expandable member across at least a portion of the expandable member.
In one aspect, the at least one mechanical engagement feature comprises a cutting portion.
In one aspect, the at least one mechanical engagement feature comprises a blunted tip.
In one aspect, the device further includes a fluid source; a fluid lumen positioned in the elongate catheter and in fluid communication with the fluid source; a jet orifice positioned near or within the expandable funnel and in fluid communication with the fluid lumen, the jet orifice being configured to provide a fluid stream within the expandable member.
In one aspect, the at least one mechanical engagement feature is actuatable to move the at least one mechanical engagement within the expandable funnel towards the fluid stream.
In one aspect, at least one mechanical engagement feature is in fluid communication with the fluid lumen and is further configured to provide a second fluid stream within the aspiration lumen or within the expandable funnel.
In one aspect, the expandable member comprises a frame configured to self-expand the expandable member to a fully expanded configuration.
In one aspect, the expandable member further comprises a compliant material disposed over at least a portion of the frame.
In one aspect, the device further includes an actuatable frame mechanically coupled to the at least one mechanical engagement feature, the actuatable frame having at least a portion positioned proximally from the frame.
In one aspect, the device further includes a sheath configured to slide axially over the elongate catheter, wherein relative movement therebetween to place the sheath into contact with the actuatable frame moves the at least one mechanical engagement feature within the expandable member.
In one aspect, placing the sheath into contact with the actuatable frame does not collapse or reduce a diameter of the expandable member.
In one aspect, the at least one mechanical engagement feature is coupled to the frame at a hinge.
In one aspect, a distal portion of the at least one mechanical engagement feature extends from the hinge into the expandable member and a proximal portion of the at least one mechanical engagement feature extends outside of the expandable member.
In one aspect, the device further includes a sheath configured to slide axially over the elongate catheter, wherein relative movement therebetween to place the sheath into contact with the proximal portion of the at least one mechanical engagement feature moves the distal portion of the at least one mechanical engagement feature about the hinge within the expandable member.
In one aspect, the device further includes a sheath configured to rotate around the elongate catheter, wherein rotating the sheath into contact with the proximal portion of the at least one mechanical engagement feature moves the distal portion of the at least one mechanical engagement feature about the hinge within the expandable member.
In one aspect, the at least one mechanical engagement feature includes a pair of mechanical engagement features configured to collide at a pinch point when actuated.
In one aspect, the at least one mechanical engagement feature includes a pair of mechanical engagement features configured to create a shearing action when actuated.
In one aspect, the at least one mechanical engagement feature comprises a plurality of mechanical engagement features that are collectively actuated as a group.
In one aspect, the at least one mechanical engagement feature comprises a plurality of mechanical engagement features that are individually and independently actuated.
In one aspect, the at least one mechanical engagement feature comprises a first group of mechanical engagement features that can be actuated independently from a second group of mechanical engagement features.
In one aspect, the at least one mechanical engagement feature comprises a first mechanical engagement feature disposed within the expandable member at a first axial position and a second mechanical engagement feature disposed within the expandable member at a second axial position distal to the first axial position.
In one aspect, the at least one mechanical engagement feature comprises a plurality of mechanical engagement features configured to move towards a central point within the expandable member.
In one aspect, the at least one mechanical engagement feature includes an at-rest configuration in which the at least one mechanical engagement feature is positioned adjacent to or abutting against the compliant material.
In one aspect, the compliant material further comprises at least one pocket corresponding to each of the at least one mechanical engagement features, wherein the at least one mechanical engagement feature includes an at-rest configuration in which the at least one mechanical engagement feature is positioned within its corresponding pocket within the compliant material.
In one aspect, the compliant material further comprises at least one slit corresponding to each of the at least one mechanical engagement features, wherein the at least one mechanical engagement feature includes an at-rest configuration in which the at least one mechanical engagement feature covered by the compliant material and an actuated configuration in which the at least one mechanical engagement feature passes through its corresponding slit to move into the expandable member.
In one aspect, actuation of the at least one mechanical engagement feature causes the at least one mechanical engagement feature to pivot within the expandable member.
In one aspect, the elongate catheter extends along a longitudinal axis, and further wherein the expandable funnel and at least a portion of the at least one mechanical engagement feature are configured to maintain respective axial positions with respect to the longitudinal axis during actuation of the at least one mechanical engagement feature.
In one aspect, the at least one mechanical feature does not extend beyond a distal end of the expandable member.
A thrombus removal device is provided, comprising: an elongate catheter having an aspiration lumen and a fluid lumen; an aspiration source coupled to the aspiration lumen; a fluid source coupled to the fluid lumen; an expandable funnel coupled to the aspiration lumen and the elongate catheter; a jet orifice positioned near or within the expandable funnel and in fluid communication with the fluid lumen, the jet orifice being configured to provide a fluid stream within the aspiration lumen or within the expandable funnel; at least one mechanical engagement feature disposed within the expandable funnel, wherein the at least one mechanical engagement feature is actuatable to move the at least one mechanical engagement feature within the expandable funnel towards a plane of the fluid stream.
In one aspect, the at least one mechanical engagement feature is actuatable to move the at least one mechanical engagement within the expandable funnel towards the aspiration lumen.
In one aspect, the at least one mechanical engagement feature is actuatable to move the at least one mechanical engagement feature generally radially within the expandable funnel across at least a portion of the expandable funnel.
In one aspect, the at least one mechanical engagement feature comprises a cutting portion.
In one aspect, the at least one mechanical engagement feature comprises a blunted tip.
In one aspect, the at least one mechanical engagement feature is actuatable to move the at least one mechanical engagement within the expandable funnel towards the fluid stream.
In one aspect, at least one mechanical engagement feature is in fluid communication with the fluid lumen and is further configured to provide a second fluid stream within the aspiration lumen or within the expandable funnel.
In one aspect, the expandable funnel comprises a funnel frame configured to self-expand the funnel to a fully expanded configuration.
In one aspect, the expandable funnel further comprises a compliant material disposed over at least a portion of the funnel frame.
In one aspect, the device further includes an actuatable frame mechanically coupled to the at least one mechanical engagement feature, the actuatable frame having at least a portion positioned proximally from the funnel frame.
In one aspect, the device further includes a sheath configured to slide axially over the elongate catheter, wherein relative movement therebetween to place the sheath into contact with the actuatable frame moves the at least one mechanical engagement feature within the expandable funnel.
In one aspect, placing the sheath into contact with the actuatable frame does not collapse or reduce a diameter of the expandable funnel.
In one aspect, the at least one mechanical engagement feature is coupled to the funnel frame at a hinge.
In one aspect, a distal portion of the at least one mechanical engagement feature extends from the hinge into the expandable funnel and a proximal portion of the at least one mechanical engagement feature extends outside of the funnel.
In one aspect, a sheath configured to slide axially over the elongate catheter, wherein relative movement therebetween to place the sheath into contact with the proximal portion of the at least one mechanical engagement feature moves the distal portion of the at least one mechanical engagement feature about the hinge within the expandable funnel.
In one aspect, the device further includes a sheath configured to rotate around the elongate catheter, wherein rotating the sheath into contact with the proximal portion of the at least one mechanical engagement feature moves the distal portion of the at least one mechanical engagement feature about the hinge within the expandable funnel.
In one aspect, the at least one mechanical engagement feature includes a pair of mechanical engagement features configured to collide at a pinch point when actuated.
In one aspect, the at least one mechanical engagement feature includes a pair of mechanical engagement features configured to create a shearing action when actuated.
In one aspect, the at least one mechanical engagement feature comprises a plurality of mechanical engagement features that are collectively actuated as a group.
In one aspect, the at least one mechanical engagement feature comprises a plurality of mechanical engagement features that are individually and independently actuated.
In one aspect, the at least one mechanical engagement feature comprises a first group of mechanical engagement features that can be actuated independently from a second group of mechanical engagement features.
In one aspect, the at least one mechanical engagement feature comprises a first mechanical engagement feature disposed within the expandable funnel at a first axial position and a second mechanical engagement feature disposed within the expandable funnel at a second axial position distal to the first axial position.
In one aspect, the at least one mechanical engagement feature comprises a plurality of mechanical engagement features configured to move towards a central point within the expandable funnel.
In one aspect, the at least one mechanical engagement feature includes an at-rest configuration in which the at least one mechanical engagement feature is positioned adjacent to or abutting against the compliant material.
In one aspect, the compliant material further comprises at least one pocket corresponding to each of the at least one mechanical engagement features, wherein the at least one mechanical engagement feature includes an at-rest configuration in which the at least one mechanical engagement feature is positioned within its corresponding pocket within the compliant material.
In one aspect, the compliant material further comprises at least one slit corresponding to each of the at least one mechanical engagement features, wherein the at least one mechanical engagement feature includes an at-rest configuration in which the at least one mechanical engagement feature covered by the compliant material and an actuated configuration in which the at least one mechanical engagement feature passes through its corresponding slit to move into the expandable funnel.
In one aspect, actuation of the at least one mechanical engagement feature causes the at least one mechanical engagement feature to pivot within the expandable funnel.
In one aspect, the elongate catheter extends along a longitudinal axis, and further wherein the expandable funnel and at least a portion of the at least one mechanical engagement feature are configured to maintain respective axial positions with respect to the longitudinal axis during actuation of the at least one mechanical engagement feature.
In one aspect, the at least one mechanical feature does not extend beyond a distal end of the expandable funnel.
A thrombus removal device, comprising: an elongate catheter having an aspiration lumen; an aspiration source coupled to the aspiration lumen; an expandable funnel coupled to the aspiration lumen and the elongate catheter, the expandable funnel comprising a frame; at least one mechanical engagement feature disposed within the expandable funnel; and a sheath slidably disposed along an outside of the elongate catheter, wherein relative movement between the sheath and the elongate catheter places the sheath into contact with a portion of the expandable funnel to cause the at least one mechanical engagement feature to move within the funnel.
In one aspect, the at least one mechanical engagement feature is actuatable to move the at least one mechanical engagement within the expandable funnel towards the aspiration lumen.
In one aspect, the at least one mechanical engagement feature is actuatable to move the at least one mechanical engagement feature generally radially within the expandable funnel across at least a portion of the expandable funnel.
In one aspect, the at least one mechanical engagement feature comprises a cutting portion.
In one aspect, the at least one mechanical engagement feature comprises a blunted tip.
In one aspect, the device further includes a fluid source; a fluid lumen positioned in the elongate catheter and in fluid communication with the fluid source; a jet orifice positioned near or within the expandable funnel and in fluid communication with the fluid lumen, the jet orifice being configured to provide a fluid stream within the aspiration lumen or within the expandable funnel.
In one aspect, the at least one mechanical engagement feature is actuatable to move the at least one mechanical engagement within the expandable funnel towards the fluid stream.
In one aspect, at least one mechanical engagement feature is in fluid communication with the fluid lumen and is further configured to provide a second fluid stream within the aspiration lumen or within the expandable funnel.
In one aspect, the expandable funnel comprises a funnel frame configured to self-expand the funnel to a fully expanded configuration.
In one aspect, the expandable funnel further comprises a compliant material disposed over at least a portion of the funnel frame.
In one aspect, the device further includes an actuatable frame mechanically coupled to the at least one mechanical engagement feature, the actuatable frame having at least a portion positioned proximally from the funnel frame.
In one aspect, the at least one mechanical engagement feature is coupled to the funnel frame at a hinge.
In one aspect, a distal portion of the at least one mechanical engagement feature extends from the hinge into the expandable funnel and a proximal portion of the at least one mechanical engagement feature extends outside of the funnel.
In one aspect, the at least one mechanical engagement feature includes a pair of mechanical engagement features configured to collide at a pinch point when actuated.
In one aspect, the at least one mechanical engagement feature includes a pair of mechanical engagement features configured to create a shearing action when actuated.
In one aspect, the at least one mechanical engagement feature comprises a plurality of mechanical engagement features that are collectively actuated as a group.
In one aspect, the at least one mechanical engagement feature comprises a plurality of mechanical engagement features that are individually and independently actuated.
In one aspect, the at least one mechanical engagement feature comprises a first group of mechanical engagement features that can be actuated independently from a second group of mechanical engagement features.
In one aspect, the at least one mechanical engagement feature comprises a first mechanical engagement feature disposed within the expandable funnel at a first axial position and a second mechanical engagement feature disposed within the expandable funnel at a second axial position distal to the first axial position.
In one aspect, the at least one mechanical engagement feature comprises a plurality of mechanical engagement features configured to move towards a central point within the expandable funnel.
In one aspect, the at least one mechanical engagement feature includes an at-rest configuration in which the at least one mechanical engagement feature is positioned adjacent to or abutting against the compliant material.
In one aspect, the compliant material further comprises at least one pocket corresponding to each of the at least one mechanical engagement features, wherein the at least one mechanical engagement feature includes an at-rest configuration in which the at least one mechanical engagement feature is positioned within its corresponding pocket within the compliant material.
In one aspect, the compliant material further comprises at least one slit corresponding to each of the at least one mechanical engagement features, wherein the at least one mechanical engagement feature includes an at-rest configuration in which the at least one mechanical engagement feature covered by the compliant material and an actuated configuration in which the at least one mechanical engagement feature passes through its corresponding slit to move into the expandable funnel.
In one aspect, actuation of the at least one mechanical engagement feature causes the at least one mechanical engagement feature to pivot within the expandable funnel.
In one aspect, the elongate catheter extends along a longitudinal axis, and further wherein the expandable funnel and at least a portion of the at least one mechanical engagement feature are configured to maintain respective axial positions with respect to the longitudinal axis during actuation of the at least one mechanical engagement feature.
In one aspect, the at least one mechanical feature does not extend beyond a distal end of the expandable funnel.
A method of removing thrombus from a patient, comprising: inserting a thrombectomy catheter into the patient; expanding a distal expandable member of the catheter adjacent to a target thrombus; aspirating the target thrombus into the distal expandable member; actuating at least one mechanical engagement feature within the funnel to contact the target thrombus; and aspirating the target thrombus out of the thrombectomy catheter.
In one aspect, the method further includes directing at least two intersecting jet streams into the target thrombus within the distal expandable member.
In one aspect, actuating the at least one mechanical engagement feature further comprises cutting the target thrombus with the at least one mechanical engagement feature.
In one aspect, actuating the at least one mechanical engagement feature further comprises pinching the target thrombus with the at least one mechanical engagement feature.
In one aspect, actuating the at least one mechanical engagement feature further comprises shearing the target thrombus with the at least one mechanical engagement feature.
In one aspect, actuating the at least one mechanical engagement feature further comprises moving the at least one engagement feature towards an aspiration lumen of the thrombectomy catheter.
In one aspect, actuating the at least one mechanical engagement feature further comprises moving the at least one engagement feature radially across the distal expandable member.
In one aspect, actuating the at least one mechanical engagement feature further comprises moving the at least one engagement feature towards a plane of the intersecting jet streams.
A thrombus removal device, comprising: an elongate shaft having a distal end; at least one aspiration lumen in the elongate shaft; an expandable funnel disposed at or near the distal end, the funnel comprising: a nested frame structure comprising an actuatable frame structure proximal to a funnel frame structure; at least one mechanical engagement feature coupled to or integral with the actuatable frame structure; and a sheath slideably disposed over the elongate shaft, wherein the sheath is configured to engage the actuatable frame structure to actuate the at least one mechanical engagement feature between an open or expanded configuration and a closed or actuated configuration.
In one aspect, engaging the actuatable frame structure with the sheath does not cause engagement between the sheath and the funnel frame structure.
In one aspect, the device further includes a compliant material disposed around the funnel frame structure and at least a portion of the actuatable frame structure.
In one aspect, the compliant material is not disposed around the at least one mechanical engagement feature.
In one aspect, the device further includes at least one pocket disposed in the compliant material, the pocket being configured to receive the at least one mechanical engagement feature when the at least one mechanical engagement feature is in the open configuration.
In one aspect, the device further includes at least one slit in the compliant material over each of the at least one pockets, the at least one slit being configured to allow the mechanical engagement feature to emerge from the at least one pocket when being actuated between the open configuration and closed or actuated configuration.
In one aspect, the device further includes a cutting or serrated edge on the at least one mechanical engagement feature.
In one aspect, at least one mechanical engagement feature is directed towards the aspiration lumen in the closed or actuated configuration.
A method for removing a thrombus from a blood vessel of a patient with a thrombus removal device is provided, the method comprising: introducing a distal portion of a thrombus removal device to a thrombus location in a blood vessel; retracting a sheath along an elongate shaft of the thrombus removal device to expand a funnel at the thrombus location; operating an aspiration source of the thrombus removal device to at least partially capture a thrombus in the funnel; advancing the sheath along the elongate shaft to engage a frame structure of the funnel and to cause at least one mechanical engagement feature of the funnel to actuate from an open configuration to a closed configuration.
In one aspect, actuating the at least one mechanical engagement feature from the open configuration to the closed configuration does not collapse the funnel.
In one aspect, the at least one mechanical engagement feature moves towards an aspiration lumen of the elongate shaft in the closed configuration.
A thrombus removal device is provided, comprising: an elongate shaft; at least one aspiration lumen in the elongate shaft; a funnel disposed at a distal end of the elongate shaft; an array of mechanical engagement features operably positioned within the funnel, the array comprising one or more axially spaced mechanical engagement feature layers actuatable to engage thrombus material.
A method for removing thrombus from a blood vessel of a patient with a thrombus removal device is provided, the method comprising: obtaining a pre-treatment image representative of a thrombus; introducing a distal portion of an elongate catheter in a blood vessel to a target location near the thrombus; operating an aspiration source of the elongate catheter; removing the thrombus from the patient with the aspiration source through the thrombus removal device; and determining a volume of the thrombus removed from the patient.
In one aspect, the method further comprises calculating a pre-treatment volume of the thrombus from the pre-treatment image.
In one aspect, determining the volume further comprises: obtaining a post-treatment image of the thrombus; calculating a post-treatment volume of the thrombus from the post-treatment image; and comparing the post-treatment volume to the pre-treatment volume.
In one aspect, the method further comprises measuring a parameter related to removing the thrombus.
In one aspect, measuring the parameter further comprises measuring a flow rate or pressure.
In one aspect, determining the volume further comprises estimating or calculating the volume of thrombus removed based on the measured parameter.
In one aspect, the method further comprises calculating a pre-treatment volume of the thrombus from the pre-treatment image; comparing the estimated or calculated volume of thrombus removed to the pre-treatment volume.
In one aspect, the method further comprises moving the distal portion of the catheter to another location near another thrombus; and removing the another thrombus.
In one aspect, the method further comprises generating an indicator that sufficient thrombus has been removed; and displaying a representation of the indicator.
In one aspect, the indicator is based on one of the thrombus, the another thrombus, and a combination thereof.
A console for controlling a thrombectomy catheter is provided, comprising: a pump for controlling aspiration through the thrombectomy catheter; a sensor for measuring a volume of thrombus removed through the thrombectomy catheter; and a processor including instructions for determining a pre-treatment volume of thrombus in a treatment location and comparing the volume of thrombus removed to the pre-volume.
A thrombus removal device console is provided, comprising: an aspiration source; a cannister fluidly coupled to the aspiration source, the cannister being configured to be fluidly coupled to an aspiration lumen of a thrombus removal device; a sensor disposed in the cannister, the sensor being configured to characterize or determine an amount of fluid or biological materials removed from a patient.
In one aspect, the sensor comprises a weight scale.
In one aspect, the sensor comprises a camera.
In one aspect, the canister further comprises a filter configure to allow blood and/or fluid to drain from the cannister but not clots.
In one aspect, the console further includes a fluid source and a second sensor disposed on or in the fluid source.
In one aspect, the second sensor comprises a flow sensor or a weight scale configured to measure a volume or weight of fluid delivered from the fluid source.
This application is related to disclosure in International Application No. PCT/US2021/020915, filed Mar. 4, 2021 (the '915 application), and International Application No. PCT/US2022/033024, filed Jun. 10, 2022 (the '024 application), the disclosures of which are incorporated by reference herein for all purposes. The '915 and '024 applications describes general mechanisms for capturing and removing a clot. By example, multiple fluid streams are directed toward the clot to fragment the material.
The present technology is generally directed to thrombus removal systems and associated methods. A system configured in accordance with an embodiment of the present technology can include, for example, an elongated catheter having a distal portion configured to be positioned within a blood vessel of the patient, a proximal portion configured to be external to the patient, a fluid delivery mechanism configured to fragment the thrombus with pressurized fluid, an aspiration mechanism configured to aspirate the fragments of the thrombus, and one or more lumens extending at least partially from the proximal portion to the distal portion.
The terminology used in the description presented below is intended to be interpreted in its broadest reasonable manner, even though it is being used in conjunction with a detailed description of certain specific embodiments of the present technology. Certain terms may even be emphasized below; however, any terminology intended to be interpreted in any restricted manner will be overtly and specifically defined as such in this Detailed Description section. Additionally, the present technology can include other embodiments that are within the scope of the examples but are not described in detail with respect to the figures.
Reference throughout this specification to “one embodiment” or “an embodiment” means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present technology. Thus, the appearances of the phrases “in one embodiment” or “in an embodiment” in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features or characteristics may be combined in any suitable manner in one or more embodiments.
Reference throughout this specification to relative terms such as, for example, “generally,” “approximately,” and “about” are used herein to mean the stated value plus or minus 10%.
Although some embodiments herein are described in terms of thrombus removal, it will be appreciated that the present technology can be used and/or modified to remove other types of emboli that may occlude a blood vessel, such as fat, tissue, or a foreign substance. Additionally, although some embodiments herein are described in the context of thrombus removal from a pulmonary artery (e.g., pulmonary embolectomy), the technology may be applied to removal of thrombi and/or emboli from other portions of the vasculature (e.g., in neurovascular, coronary, within chambers of the heart, or peripheral applications). Moreover, although some embodiments are discussed in terms of maceration of a thrombus with a fluid, the present technology can be adapted for use with other techniques for breaking up a thrombus into smaller fragments or particles (e.g., ultrasonic, mechanical, enzymatic, etc.).
The headings provided herein are for convenience only and do not interpret the scope or meaning of the claimed present technology.
As provided above, the present technology is generally directed to thrombus removal systems. Such systems include an elongated catheter having a distal portion positionable within a blood vessel of the patient (e.g., an artery or vein), a proximal portion positionable outside the patient's body, a fluid delivery mechanism configured to fragment the thrombus with pressurized fluid, an aspiration mechanism configured to aspirate the fragments of the thrombus, and one or more lumens extending at least partially from the proximal portion to the distal portion. In some embodiments, the systems herein are configured to engage a thrombus in a patient's blood vessel, break the thrombus into small fragments, and aspirate the fragments out of the patient's body. The pressurized fluid streams (e.g., jets) function to cut or macerate thrombus, before, during, and/or after at least a portion of the thrombus has entered the aspiration lumen or a funnel of the system. Fragmentation helps to prevent clogging of the aspiration lumen and allows the thrombus removal system to macerate large, firm clots that otherwise could not be aspirated. As used herein, “thrombus” and “embolism” are used somewhat interchangeably in various respects. Typically a thrombus is a portion of clotted blood that has stopped moving through the vasculature and is lodged or stuck and the emboli is a portion of clotted blood that is moving in the vasculature that can eventually become a thrombus and additionally seed a larger thrombus either by collecting other emboli or blood clotting on the thrombus.
It should be appreciated that while the description may refer to removal of “thrombus,” this should be understood to encompass removal of thrombus fragments and other emboli as provided herein.
According to embodiments of the present technology, a fluid delivery mechanism can provide a plurality of fluid streams (e.g., jets) to fluid apertures of the thrombus removal system for macerating, cutting, fragmenting, pulverizing and/or urging thrombus to be removed from a proximal portion of the thrombus removal system. The thrombus removal system can include an aspiration lumen extending at least partially from the proximal portion to the distal portion of the thrombus removal system that is adapted for fluid communication with an aspiration pump (e.g., vacuum source). In operation, the aspiration pump may generate a volume of lower pressure within the aspiration lumen near the proximal portion of the thrombus removal system, urging aspiration of thrombus from the distal portion to the proximal portion.
In various embodiments, the system can have an average flow velocity within the fluid lumen of up to 20 m/s to achieve consistent and successful aspiration of clots. In some embodiments, the fluid source itself can be delivered in a pulsed sequence or a preprogrammed sequence that includes some combination of pulsatile flow and constant flow to deliver fluid to the jets. In these embodiments, while the average pulsed fluid velocity may be up to 20 m/s, the peak fluid velocity in the lumen may be up to 30 m/s or more during the pulsing of the fluid source. In some embodiments, the jets or apertures have an aperture size ranging between 0.005″ to 0.020″ to avoid undesirable spraying of fluid. In some embodiments, the system can have a minimum vacuum or aspiration pressure of 15 inHg, to remove target clots after they have been macerated or broken up with the jets described above.
The thrombus removal system can be sized and configured to access and remove thrombi in various locations or vessels within a patient's body. It should be understood that while the dimensions of the system may vary depending on the target location, generally similar features and components described herein may be implemented in the thrombus removal system regardless of the application. For example, a thrombus removal system configured to remove pulmonary embolism (PE) from a patient may have an outer wall/tube with a size of approximately 11-13 Fr, or preferably 12 Fr, and an inner wall/tube with a size of 7-9 Fr, or preferably 8 Fr. A deep vein thrombosis (DVT) device, on the other hand, may have an outer wall/tube with a size of approximately 9-11 Fr, or preferably 10 Fr, and an inner wall/tube with a size of 6-9 Fr, or preferably 7.5 Fr. Applications are further provided for ischemic stroke and peripheral embolism applications.
Section B-B of
Section B-B of
It should be understood that in some embodiments, all the fluid lumens are fluidly connected to all of the jets or apertures of the thrombus removal device. Therefore, when a flow of fluid is delivered from the fluid lumen(s) to the jets, all jets are activated with a jet of fluid at once. However, it should also be understood that in some embodiments, the fluid lumens are separate or distinct, and these distinct fluid lumens may be fluidly coupled to one or more jets but not to all jets of the device. In these embodiments, a subset of the jets can be controlled by delivering fluid only to the fluid lumens that are coupled to that subset of jets. This enables additional functionality in the device, in which specific jets can be activated in a user defined or predetermined order.
In various embodiments, the fluid pressure is generated at the pump (at the console or handle). The fluid is accelerated as it exits through the ports at the distal end and is directed to the target clot. In this way a wider variety of cost-effective components can be used to form the catheter while still maintaining a highly-effective device for clot removal. Additional details are provided below.
Section B-B of
Section B-B of
Section B-B of
Section C-C of
Detail View 101 of
The manifold is configured to increase a fluid pressure and/or flow rate of the fluid. When fluid is provided by the fluid delivery mechanism to the fluid lumen(s) at a first pressure and/or a first flow rate, the manifold is configured to increase the pressure of the fluid to a second pressure and/or is configured to increase the flow rate of the fluid to a second flow rate. The second pressure and/or second fluid rate can be higher than the first pressure and/or first flow rate. As a result, the manifold can be configured to increase the relatively low operating pressures and/or flow rates generated by the fluid delivery mechanism to the relatively high pressures and/or high flow rates generated by the ports/fluid streams.
In some embodiments, a profile (cross-sectional dimension) of a port 230 varies along its length (e.g., is non-cylindrical). A variation in the cross-sectional dimension of the port may alter and/or adjust a characteristic of fluid flow along the port 230. For example, a reduction in cross-sectional dimension may accelerate a flow of fluid through the port 230 (for a given volume of fluid). In some embodiments, a port 230 may be conical along its length (e.g., tapered), such that its smallest dimension is positioned at the distal end of the port 230, where distal is with respect to a direction of fluid flow.
In some embodiments, the port 230 is formed to direct the fluid flow along a selected path.
In some embodiments, the fluid streams are configured to create angular momentum that is imparted to a thrombus. In some examples, angular momentum is imparted on the thrombus by application of a) at least one fluid stream 210 that is directed at an oblique angle from a port 230, and/or b) at least two fluid streams 210 that have different fluid velocities. For example, fluid streams that cross near each other but do not necessarily intersect may create a “swirl” or rotational energy on the clot material. Advantageously, angular momentum produced in a thrombus may impart a (e.g., centrifugal) force that assists in fragmentation and removal of the thrombus. Rotating of the clot may enhance delivery of the clot material to the jets. By example, with a large, amorphous clot the soft material may be easily aspirated or broken up by the fluid streams whereas tough fibrin may be positioned away from the fluid streams. Rotating or swirling of the clot moves the material around so the harder clot material is presented to the jets. The swirling may also further break up the clot as it is banged inside the funnel.
Still referring to
As is described above, aspiration occurs down the central lumen of the device and is provided by a vacuum pump in the console. The vacuum pump can include a container that collects any thrombus or debris removed from the patient.
In
In some embodiments, the cannister itself can include a drain with a drain size or filter configured to allow drainage of fluids from the cannister (such as blood and/or saline) while preventing clot material or other biological tissues from draining from the cannister. In this manner, the cannister and weight scale(s) are able to measure only the weight of the clot removed, and not blood and/or saline. Optionally, the blood and other fluids such as saline can be drained into a separate cannister (not shown), which can then be used to determine the amount of blood removed from the patient in addition to the amount of clot removed. In one implementation, fluid source 606 can also include sensor 609, which can be used to track the amount of fluid or saline delivered to the patient through jetting. The sensor 609 can comprise, for example, additional weight scales, or optionally, any other sensor configured to measure the flow of fluid such as a flow sensor. The fluid delivered by the fluid source 606 can be measured by sensor 609 and subtracted from the fluid drained into the separate (not shown) cannister. Therefore, the amount of clot can be determined with weight scales 607 in the cannister 604, and the amount of blood can be calculated in the separate container by subtracting the collected volume from the amount of saline delivered.
In another embodiment, the sensor 607 on or in the cannister 604 can comprise a camera. In some embodiments, the camera can comprise a miniature or fiber optic camera. In some implementations, the camera can be configured to provide real-time imaging of the cannister to provide a visual guide to the user regarding what is being aspirated from the patient. For example, the user can visualize the amount and/or size of clot being removed. The images from the camera can be displayed for the user, such as on a display that provides additional information about the status of the system, device, and procedure.
In other embodiments, the sensor 607 on or in the cannister 604 can comprise other types of sensors, such as optical sensors, flow sensors, etc. Generally, the sensors can be used to monitor or characterize the amount and/or type of material or fluid that enters the cannister to provide the user with additional information regarding the status of the therapy.
Mechanical Manipulation Features for Engagement with Tissue or Material at Distal End of Device (e.g., Grabber Arms)
Some embodiments of a thrombus removal device can include features enabling mechanical manipulation or engagement with tissue or material at a distal end of the device. These features can be referred to herein as mechanical engagement features, grabber arms, fangs, mechanical manipulation arms, mechanical cutting arms, or the like. The grabber arms are generally designed and configured to engage and pull clots into the distal end of the device (e.g., the funnel and/or aspiration lumen). In various implementations, the mechanical engagement features disclosed herein are configured to achieve some combination of pulling thrombus into the funnel, pulling thrombus into the jet plane, pulling thrombus into the aspiration lumen, and/or breaking off or cutting pieces of the thrombus into pieces sufficiently small to be aspirated through the aspiration lumen. While the thrombus removal systems described herein generally include an aspiration lumen and one or more fluid streams or jets, it should be understood that the grabber arms may be implemented in devices without aspiration lumens or without one or more fluid streams or jets. Additionally, the devices described herein generally include an expandable funnel on the distal end of the device. However it should be understood that some embodiments with mechanical engagement features may not include an expandable funnel, but instead some other structure on or near the distal end of the device.
Mechanical engagement features can comprise an arrangement of fangs, arms, or actuatable members positionable at a distal end of a device, such as a thrombus removal device. In some embodiments, the mechanical engagement features are positioned within a distal end of the device (e.g., within a funnel of the device), however other embodiments contemplate positioning the mechanical engagement features outside of the distal end (e.g., funnel), or alternatively, inside an aspiration lumen of the device.
The mechanical engagement features described herein do not include any components that extend distally beyond the distal end of the expandable member or funnel. In general, all actuation or movement of the mechanical engagement features is provided within the confines of the expandable member or funnel. In some embodiments, the mechanical engagement features can include cutting or serrated edges, sharp points, or shearing/pinching mechanisms of action against a targeted clot or tissue. Maintaining the entirety of the mechanical engagement features within the funnel or expandable member increases patient safety and prevents accidentally damaging, cutting, or piercing sensitive tissues such as vessel walls.
The mechanical engagement features described herein can generally include an at-rest state in which the mechanical engagement features are generally not obstructing a central or aspiration lumen of the device (e.g., resting near, adjacent to, or against an inner wall of the expandable member or funnel). The mechanical engagement features can also include an actuated or closed state in which the mechanical engagement features are manipulated to move, either axially and/or radially, towards the central or aspiration lumen of the device. However, in some embodiments, the at rest state includes engagement members that extend into the expandable member or funnel, and an actuated state in which the engagement members are near, rest against, or contact the funnel or expandable member. In some embodiments, this manipulation causes the mechanical engagement features to move axially towards the central or aspiration lumen, and in other embodiments, the manipulation causes the mechanical engagement features to move radially across the expandable member or funnel towards or across a central axis of the opening.
Generally, actuation or manipulation of the mechanical engagement features results in movement along a pivot within the expandable member or funnel. The pivot provides an inflection point between the mechanical engagement feature and the actuating member (e.g., a pull wire, an outer sheath, etc.). While this disclosure discussed movement of the mechanical engagement features as either being axially (e.g., distal to proximal) or radially (e.g., across the funnel or expandable member) it should be understood that since the mechanical engagement features of this disclosure typically move along a pivot, the movement characteristics may be more complex (e.g., a mechanical engagement feature may first swing radially towards a center of the expandable member or funnel before then swinging more axially towards the opening or aspiration lumen of the device).
The mechanical engagement features described herein typically also are directed or face inwards towards a central axis of the device (as opposed to facing outwards towards a vessel wall.
Referring still to
In some implementations, the mechanical engagement features of
Referring to
Each subsequent drawing,
The ability to manipulate the mechanical engagement features provides additional functionality to a medical device such as a thrombectomy removal device during therapy. For example, in some embodiments, the mechanical engagement feature(s) can be designed and configured to engage with a clot that is in the funnel. In some embodiments, this physical or mechanical interaction with the clot can be leveraged so as to physically pull or move the clot into contact with the device. Depending on the configuration of the device (e.g., funnel, aspiration lumen, one or more jets, etc.), the mechanical engagement features can be used to 1) pull the clot into contact with jets or into a plane of the jets, to thereby break up the clot and aspirate the clot, 2) pull the clot into or towards the aspiration lumen, and/or 3) prevent the clot from exiting the distal end or funnel of the device. The combination of the mechanical engagement features, the jets, and aspiration allow for clot removal capabilities not previously enabled by other devices. The combination can also cut or help cut the clot while pushing it into the aspiration lumen or jet plane.
The distal end embodiment of
Referring to
Referring to
Referring to
As described above, several embodiments of actuation for the mechanical engagement features can be implemented. In one embodiment, an outer sheath is cooperatively coupled with the medical device such that relative movement therebetween (e.g., advancement and/or rotation) causes actuation of the mechanical engagement features. In one embodiment, retraction (proximal movement) of an interference element such as a pull-wire or similar actuation element causes the mechanical engagement feature to pivot and/or rotate about a hinge.
Additional embodiments of mechanical engagement features are shown in
In the embodiment of
The mechanical engagement feature array 22 illustrated in
Referring to
In some examples, one of more layers of mechanical engagement features may be actuated independent of other mechanical engagement features layers. In some examples, one or more layers of mechanical engagement features may be actuated in combination with one or more additional mechanical engagement features layers. For example, referring to
Again referring to
In some examples, a mechanical engagement features layer may comprise a plurality of offset mechanical engagement features configured to be actuated independent or in combination with one another to engage a thrombus and retain the thrombus material in a static position while one or more mechanical engagement features layers can be actuated to impact the thrombus (e.g., shear, cut, macerate, etc.). In some examples, one or more mechanical engagement features of a layer may be configured to engage a thrombus to rotate the thrombus material. As described herein, the closure of mechanical engagement features within a layer or array may be configured to engage the thrombus material and provide rotational force to the material by closing similar to an iris around an aperture.
Similar to
In some examples, one or more mechanical engagement features or layers may comprise different characteristics configured to impact the thrombus material in a variety of ways. For example, some mechanical engagement features may be more stiff than others. Increased stiffness may provide improved cutting, macerating, or engagement with thrombus material. In some examples, mechanical engagement features with increased stiffness may be configured to cut, macerate, or otherwise deform the thrombus material while more flexible mechanical engagement features can be configured to hold, retain, or otherwise manipulate the thrombus material in support of the stiffer cutting members.
Additionally,
In some embodiments, the stiffness of the mechanical engagement feature frame structure can be tuned independently of the stiffness of the funnel frame structure. For example, it may be desirable to have a funnel that is as compliant as possible so as to avoid injuring or damaging delicate vessel structures. At the same time, it may also be desirable to have a mechanical engagement feature frame structure and mechanical engagement features that are more stiff than the funnel, to provide improved clot engagement or maceration. Alternatively, it may be desirable to have the mechanical engagement features be more compliant than the funnel itself. Regardless, in some embodiments, the mechanical engagement features frame structure is stiffer than the funnel frame structure, and in other embodiments, the mechanical engagement features frame structure is less stiff than the funnel frame structure. Alternatively, the mechanical engagement features frame structure can have substantially the same stiffness as the funnel frame structure.
In
In
In some examples, shown in
In some examples, the thrombus removal device may comprise an array having any number of mechanical engagement features layers. Each layer may be configured to manipulate the thrombus material therein as described herein. For example, a proximal layer may be configured to shear proximal thrombus segments, distal layers may also be configured to shear, retain, apply fluid pressure, enclose, rotate, macerate, etc. or a combination thereof to different segments of thrombus material therein.
In some examples, any layer may incorporate apertures and fluid lumens to provide one or more jets, as described herein. For example, referring to
In some examples, the distal tip geometry of the mechanical engagement features may be configured to engage or otherwise impact thrombus material to provide manipulation or deformation (e.g., shearing, cutting, macerating, etc.) of the thrombus material therein. For example, referring to
As described herein, one or more mechanical engagement features, layers, or arrays of mechanical engagement features may be actuated simultaneously, independently, selectively, etc. or a combination thereof. In some examples, any layer may be actuated based on the actuation or impact of one or more layers. For example, a proximal layer may be actuated, and one or more distal layers may be subsequently actuated once the proximal layer is actuated and engages the thrombus material. Some examples of layer or mechanical engagement feature articulation may include alternating mechanical engagement features (e.g., every-other mechanical engagement features) or any pattern of subsequent actuation. This manner of actuation or articulation of the mechanical engagement features may be configured to grab and/or pull thrombus material. Some examples of layer or mechanical engagement feature articulation may include sequential actuation of one or more mechanical engagement features or layers (e.g., mechanical engagement feature 1, mechanical engagement feature 2, mechanical engagement feature 3 . . . ). This manner of actuation may be configured to twist and/or rotate the thrombus material. Some examples of layer or mechanical engagement feature articulation may include varied axial position (e.g., offset or height of mechanical engagement features). This manner of actuation may be configured to retain, grab, pull, etc. the thrombus material. Some examples of layer or mechanical engagement feature articulation may include varied radial overlap of one or more mechanical engagement features of a layer. For example, mechanical engagement features may overlap, scissor, hook, curve, etc. or a combination thereof. This manner of actuation may be configured to pinch, cut, shear, etc. or a combination thereof the thrombus material. Some examples of layer or mechanical engagement features articulation may include iris closure (e.g., cyclonically, tangentially arrayed closure). This manner of actuation may be configured to twist and/or rotate the thrombus material.
In some implementations, the mechanical engagement features can serve to hold the clot within the distal end of the device, but not cut, macerate, or otherwise disrupt the clot. In one example, one or more mechanical engagement features can be actuated or positioned to hold the clot within the funnel, and the aspiration and/or jets may be oscillated on and off to break up and remote the clot from the patient. In some implementations, the jetting or fluid streams can be sequenced with mechanical engagement features actuation. For example, jetting can be turned on when the mechanical engagement features are actuated, and turned off when the mechanical engagement features are not actuated. In some examples, jetting can be turned on only after the mechanical engagement features are fully deployed or actuated, or alternatively, only when the mechanical engagement features are not deployed. Any combination of sequencing jetting and mechanical engagement features actuation is contemplated.
In some examples, actuation of one or more mechanical engagement features within the array may be based on manipulation or engagement of elongate members in operable communication with the mechanical engagement features. As described above, a sheath may be manipulated either axially or by rotation to actuate the mechanical engagement features. Movement of this sheath may be motorized or automated. In other examples, pull wires may be coupled to the mechanical engagement features and be configured to actuate the mechanical engagement features when the pull wires are engaged by a user or other actuation interface. In some examples, the pull wires can be attached or coupled to a motor configured to mechanically adjust a position of the pull wires to manipulate the mechanical engagement features. In some examples, mechanical engagement features actuation may be provided by a pneumatic system configured to adjust a pressure to the layers or mechanical engagement features for selective articulation of one or more mechanical engagement features, layers, or arrays. In some examples, operation of the mechanical engagement features may be facilitated by a thermal or electrical process. Actuation of the mechanical engagement features can be controlled, for example, with a user interface (e.g., button or GUI on a handle or console of the system). In some examples, a single user interface can be configured to control all mechanical engagement features at once. In other embodiments, multiple user interfaces or buttons can be configured to control the mechanical engagement features independently or in groups. For example, one or more mechanical engagement features may comprise a material or otherwise be configured to react to changes in temperature or electrical impulses transmitted to the mechanical engagement features. In some examples, one or more mechanical engagement features may be configured to automatically be actuated on contact (e.g., sufficient contact) with thrombus material within the distal end of the thrombus removal device. In some examples, actuation and articulation of one or more mechanical engagement features may be provided by engagement with a handle at a proximal end of the thrombus removal device (e.g., outside of a patient when in use). One or more engagement elements may be selectively controlled by a user to engage or otherwise actuate the mechanical engagement features and initiate their associated function. In some examples, one or more mechanical engagement features may be actuated by the sheath or delivery catheter. For example, a sheath may be advanced distally towards the mechanical engagement features causing actuation of the mechanical engagement features by pressure provided by the distal end of the sheath on the mechanical engagement features. In some examples, a proximal layer may be configured to transfer or transmit an actuation force to subsequent (e.g., distal layers).
In
In some examples, any of the mechanical engagement features described herein may be positioned or locatable within the funnel frame structure or an expandable distal end or tip of a medical device, as described herein. In some examples, the mechanical engagement features may be positioned within the funnel frame structure until they are actuated to engage thrombus material therein. For example, a layer having any number of mechanical engagement features may be positioned within the compliant material of the funnel frame structure and once actuated may transition from within or on the funnel frame structure to engage the thrombus material.
Systems and methods are provided herein for assessing the effectiveness and/or completion progress of thrombectomy treatment. In some embodiments, the methods can be implemented entirely in software that resides on the thrombectomy device itself or is in communication with the device. In other embodiments, the methods can be implemented in combination with hardware disposed on or in the device that provides additional information to the system/device on treatment progress.
In one embodiment, a method of assessing the effectiveness or monitoring the progress of treatment can include assessing or determining the volume of clot removal based on pre-treatment imaging (e.g., CT). Referring to the flowchart of
At step 2104, the method can then include performing a thrombectomy procedure on a targeted clot or clots using any of the devices and methods described herein.
Next, at step 2106, the method can include determining or calculating the volume of clot removed from the patient during the thrombectomy procedure. In some embodiments, this determination is done entirely in software, such as with algorithms that compare pre-treatment imaging to post-treatment imaging, determine the volume of pre-treatment clot to post-treatment clot, and identify the volume or percentage of clot removed.
In other embodiments, the determination can be based on sensor feedback from the thrombectomy device. For example, flow and/or pressure sensors outside the thrombectomy device or alternatively inside the aspiration lumen of the device can be used to measure or estimate the amount of clot removed in real-time. Alternatively, contrast agent can be delivered into the target region during treatment, such as with the jets or alternatively with a separate contrast agent lumen to allow for real-time imaging of the clot removal. In some embodiments, the contrast agent can be delivered from or near the funnel of the device. In some embodiments, additives can be added to the contrast agent which can adhere to the clot(s) and enhance the visibility of clots when the clots are removed under real-time imaging. This can then enable software or image processing solutions to estimate or determine the amount of clot removed during therapy.
In some embodiments, completion of the treatment can be determined or assessed based on a scoring system that is a composite of performance parameters (e.g., volume removed per step 2106 above) and/or physiological parameters (Sp02 increase/decrease, HR, respiratory rate, etc. recovering to normal ranges).
While the embodiments herein have been described as being intended to remove thrombi from a patient's vasculature, other applications of this technology are provided. For example, the devices described herein can be used for gastrointestinal procedures that include breaking up and removing hardened stool from the digestive tract of a patient, such as from the intestines or colon of a patient. In one embodiment, the device can be inserted into a colon or intestine of the patient (such as through the anus) and advanced to the site of hardened stool. Next, the aspiration system can be activated to engage the hardened stool with an engagement member (e.g., funnel) of the device. Finally, the jets or irrigation can be activated to break off pieces of the hardened stool and aspirate them into the system. Any of the techniques described above with respect to controlling the system or removing clots can be applied to the removal of hardened stool.
As one of skill in the art will appreciate from the disclosure herein, various components of the thrombus removal systems described above can be omitted without deviating from the scope of the present technology. As discussed previously, for example, the present technology can be used and/or modified to remove other types of emboli that may occlude a blood vessel, such as fat, tissue, or a foreign substance. Further, although some embodiments herein are described in the context of thrombus removal from a pulmonary artery, the disclosed technology may be applied to removal of thrombi and/or emboli from other portions of the vasculature (e.g., in neurovascular, coronary, or peripheral applications). Likewise, additional components not explicitly described above may be added to the thrombus removal systems without deviating from the scope of the present technology. Accordingly, the systems described herein are not limited to those configurations expressly identified, but rather encompasses variations and alterations of the described systems.
The above detailed description of embodiments of the technology are not intended to be exhaustive or to limit the technology to the precise forms disclosed above. Although specific embodiments of, and examples for, the technology are described above for illustrative purposes, various equivalent modifications are possible within the scope of the technology as those skilled in the relevant art will recognize. For example, although steps are presented in a given order, alternative embodiments may perform steps in a different order. The various embodiments described herein may also be combined to provide further embodiments.
From the foregoing, it will be appreciated that specific embodiments of the technology have been described herein for purposes of illustration, but well-known structures and functions have not been shown or described in detail to avoid unnecessarily obscuring the description of the embodiments of the technology. Where the context permits, singular or plural terms may also include the plural or singular term, respectively.
Unless the context clearly requires otherwise, throughout the description and the examples, the words “comprise,” “comprising,” and the like are to be construed in an inclusive sense, as opposed to an exclusive or exhaustive sense; that is to say, in the sense of “including, but not limited to.” As used herein, the terms “connected,” “coupled,” or any variant thereof, means any connection or coupling, either direct or indirect, between two or more elements; the coupling of connection between the elements can be physical, logical, or a combination thereof. Additionally, the words “herein,” “above,” “below,” and words of similar import, when used in this application, shall refer to this application as a whole and not to any particular portions of this application. Where the context permits, words in the above Detailed Description using the singular or plural number may also include the plural or singular number respectively. As used herein, the phrase “and/or” as in “A and/or B” refers to A alone, B alone, and A and B. Additionally, the term “comprising” is used throughout to mean including at least the recited feature(s) such that any greater number of the same feature and/or additional types of other features are not precluded. It will also be appreciated that specific embodiments have been described herein for purposes of illustration, but that various modifications may be made without deviating from the technology. Further, while advantages associated with some embodiments of the technology have been described in the context of those embodiments, other embodiments may also exhibit such advantages, and not all embodiments need necessarily exhibit such advantages to fall within the scope of the technology. Accordingly, the disclosure and associated technology can encompass other embodiments not expressly shown or described herein.
This application claims the benefit of priority to U.S. Application No. 63/267,530, filed Feb. 3, 2022, U.S. Application No. 63/269,380, filed Mar. 15, 2022, U.S. Application No. 63/373,413, filed Aug. 24, 2022, and U.S. Application No. 63/373,427, filed Aug. 24, 2022, each of which are herein incorporated by reference in its entirety.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US2023/062002 | 2/3/2023 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 63267530 | Feb 2022 | US | |
| 63269380 | Mar 2022 | US | |
| 63373413 | Aug 2022 | US | |
| 63373427 | Aug 2022 | US |
