Apparatuses, systems and methods for blood clot and tumor removal

Abstract

Apparatuses, systems and methods disclosed herein can provide to the neurosurgeon features and functions needed for a surgical procedure in a package that will allow for efficient and effective remove of the clot or tumor without the need for a craniotomy. The apparatuses, systems, and methods can provide initial assessment of the clot or tumor, its size, location and status, aid in planning of the surgical procedure (from scalp incision to trajectory and depth of insertion of the cannula,), controlled addition and removal of temperature-controlled fluid to the clot or tumor site, precise and controlled removal of the clot or tumor, confirmation of desired removal, and cauterization. The surgical procedure can be performed with real time visualization on adjacent video monitors or augmented reality displays that will allow the surgeon to "see" inside the brain.

Description

APPARATUSES, SYSTEMS AND METHODS FOR BLOOD CLOT AND TUMOR REMOVALField

[0001] The present disclosure is related to apparatuses, methods, and systems for the evacuation of blood clots, particularly for neurosurgical evacuation and aspiration procedures such as the treatment of intracranial hemorrhage, and for the removal of tumors from the brain.Background

[0002] Intracranial hemorrhage (ICH) is bleeding that occurs inside the skull. This can be the result of head injury, or more often, hemorrhagic stroke. There are two ty pes of such strokes: intracerebral hemorrhage, in which a blood vessel inside the brain bursts and leaks blood into and around surrounding brain tissue; and subarachnoid hemorrhage, in which there is bleeding in the area between the brain and the tissue covering the brain, known as the subarachnoid space. Subarachnoid hemorrhage is most often caused by a burst aneury sm.

[0003] An aneurysm is an abnormal bulge or ballooning in the wall of a blood vessel, which can occur in any part of the body, but is potentially most serious, harmful and deadly when it occurs in the brain. Aneurysms have been called a silent killer, because they usually do not cause any symptoms before the rupture, even if the pre-ruptured aneurysm is quite large.

[0004] An ICH is serious as it may crush adjacent delicate brain tissue, limit the brain's blood supply and cause potentially deadly brain herniation where parts of the brain are squeezed past structures in the skull. Hemorrhaged blood may collect and congeal into a blood clot, potentially impacting circulation in the brain, resulting in cell death. In many cases, unless treated promptly and successfully, a ruptured aneurysm in the brain is deadly. Therefore, removing or reducing hemorrhaged blood and / or blood clots in the brain as quickly and precisely as possible (so as not to damage adj acent healthy brain cells) is crucial to increasing the likelihood of patient recovery.

[0005] Intracranial hemorrhage is deadly. The estimated survival rate for hemorrhagic stroke is less than 30%. and most who die, die quickly, as the 30-day survival rate is less than 50%. Approximately one-half of these patients who die within the firstmonth die within 24 hours after onset. Even if the stroke does not cause death quickly, it remains deadly. Reported data indicates that over half ofthose patients who initially survive died from complications of the stroke within a year after onset. ICH is typically listed as one of the top five causes of death in the United States, year in and year out.

[0006] Of those patients who survive for months or years after the stroke, over two-thirds suffer long-term neurological problems and require dependent care. The potentially long-lasting deleterious effects of an ICH include some or all of the following: inability to move part(s) of the patient’s body (paralysis); numbness or weakness in part(s) of the body; difficulty swallowing; vision impairment or total loss; hearing impairment or total loss; difficulty in speaking, communicating and comprehension; personality change and / or emotional problems; and / or confusion, memory loss, or impaired judgment. Any and all of these can also present safety’ risks to the afflicted person and his or her surroundings. Many who have survived the stroke are no longer able to care for themselves, with over 60% requiring full-time dependent care.

[0007] The impact of an ICH on the patient can be and often is devastating, and the resultant strain on family members, financially and otherwise, who must cope with seeing their loved one die or suffer long term physical and mental impairment, and other health issues, and who also must provide or provide for dependent care, can also cause significant collateral damage within the family.

[0008] Sadly, the incidence of ICH is large, and is growing, as the so-called baby boomer generation is aging. According to recently released U.S. Census data, the 65- and-older population in the United States grew by over a third (34.2% or 13,787,044) during the past decade, and by 3.2% (1,688,924) from 2018 to 2019 alone. By the year 2030. the entire still-then-living baby boomers will be over age 65. Even today, there are an estimated 170,000 to 200,000 incidents of hemorrhagic stroke each year in the United States.

[0009] As this narrative demonstrates, ICH is a serious and growing risk to human health. It is also a condition that demands immediate medical treatment, which can greatly increase the survival rate, and also limit the lasting deleterious effects of the stroke.

[0010] Depending on the size and location of the ICH or blood clot, its removal may be performed via aspiration of the clot, such as with a catheter, but most often by means of a craniotomy. Surgery' is generally required if the ICH is greater than 3cm in diameter. Current "‘standard of care” treatment for such conditions requires a craniotomy. This literally provides a ‘‘window” to the brain, allowing visual and physical access by theneurosurgeon to the brain, and allowing for continued direct visualization and access during the critical period of treatment when such continued access may be desirable or necessary.

[0011] During a craniotomy, the neurosurgeon cuts and entirely removes a significant portion of the skull (up to one half of the skull) to provide physical and visual access for directly visualizing blood clots to distinguish the clot from brain tissue and to be able to safely remove the blood clot without damaging surrounding brain tissue, which is a significant risk when performing such procedures designed to remove the clot, as the same techniques and tools used to remove the clot can also damage surrounding brain tissue.

[0012] It is also important in some cases not to remove too much of the blood clot. The clotting blood is the body’s way of stopping the continued flow of blood from the ruptured vessel. The clot is in a way the body’s way of plugging the hole, so to speak. Remove too little of the clot, and the pressure on surrounding tissue is not sufficiently alleviated. Remove too much of the clot, and the bleeding resumes which could make the patient's condition worse than before. If removal of the entire clot is required, then cauterization of the vessel may be required. This too presents a significant risk to surrounding healthy brain tissue if not precisely controlled. Thus, such surgeries are high risk, and are typically accompanied by a long period of recovery.

[0013] The ability of the neurosurgeon to be able to “see"’ precisely what is going on in the brain during the neurosurgery is therefore of critical importance. Such visualization is possible with a craniotomy, but unless the large portion of the skull is removed, the surgeon can be essentially “flying blind,” or nearly so. In this regard, neuronavigation is a tool that is often used by neurosurgeons. In general, neuronavigation is a set of computer-assisted technologies used to guide or “navigate” within the confines of the skull. The ability to relate the position of a real surgical instrument in the surgeon’s hand or the microscope’s focal point to the location of the imaged pathology, updated in “real time” in an “integrated operating room,” allows the surgeon attempting to remove a blot clot to “see” the precise location of the removal tool within the brain. This same situation also exists with respect to the remove of brain tumors found in the brain.

[0014] Current technology and clinical solutions need improvement to provide desired patient outcomes. Limitations for treatment available for patients affect mortality rate and quality7of life for survivors (also for the quality of life for those who must provide dependent care for the survivors). Therefore, there is a need for improved devices and methods and tools to provide access, ease of navigation, visualization, and removal of blood clots and tumors from the brain.SUMMARY

[0015] Aspects of the present application are directed to improved devices, systems, methods and tools to provide access to, visualization, and removal of blood or tissue, such as blood clots or tumors, from the brain. One example of an improvement is a system in which the neurosurgeon can have real-time, accurate virtual visualization of a clot or tumor and the surrounding brain tissue (using MRI and CT scans) on video monitors in the operating room of the clot, the surrounding tissue, and using integrated neuronavigation, and also the precise position of the surgical device that has been inserted into the brain, without having to first perform a craniotomy. This will benefit hospitals and treatment facilities that do not have the requisite equipment on-hand to be able to determine the size and location of the clot such that the surgeons have no choice other than to perform a craniotomy, or to transport the patient to a facility that has such requisite equipment, which would involve a delay that could be very detrimental to the patient.

[0016] In some aspects, a single insertion tool is used for intracranial visualization of the clot or tumor, for providing for removal of the clot and for cauterization where that is desired, or for the insertion of other tools simultaneously while the clot removal device remains in-situ.

[0017] Some of the concepts and advantages achieved by embodiments described herein include a fully integrated system for assessment of and surgery to remove the ICH (or tumor) in a precise, controlled and minimally invasive manner and procedure. This may include using the patient’s CT or MRI and standard neuronavigation system for planning the surgical approach; a software system that integrates with neuronavigation for planning and providing continued assessment of the ICH to be removed. In-situ ultrasound visualization technology is included to determine size, geometry, volume and density of ICH and correlate and communicate that for visualization on an integrated video monitor for real-time assessment by the neurosurgeon. The integrated software assesses volume of clot removed and remaining clot based on baseline of patients CT or MRI scan. The system also provides for secondary visualization by means of an inserted neuroendoscope for direct visualization. The system can break-up acute and subacute blood clot and provide controlled aspiration. The system integrates SMART sensor technology' for pressure, temperature, and oxygenation feedback.

[0018] Some of the apparatuses disclosed will employ an elongated cannula, which will be inserted through a small hole in the skull into the brain and into the clot.Embodiments of the cannula include one that is approximately 12cm long with diameters ranging from 4mm, 5mm, 6mm, 7mm, 8mm, 9mm, 10mm, 11mm, and 12mm and is capable of accommodating multiple lumen, for example, for the controlled delivery of fluid delivery and aspiration; for appropriate safety controls in which fluid delivery to the clot location in the brain cannot exceed the rate of fluid aspiration so as to avoid introducing increased fluid pressure in situ; it can provide cautery’ to seal bleeding vessels; and it can include a steerable / deflectable tip to navigate within the clot. The cannula can include a fixed scope for visualization or a scope element that can be retracted in-situ so that the surgeon can have a wider field of visualization of the clot (or tumor) without having the withdraw the cannula itself.

[0019] One embodiment of the system and method provides localized cooling and delivery of oxygenated fluid, which in turn provides advanced neuroprotection capability during treatment. The system is able to circulate continuous hyperosmotic hypothermic solution. This reduces cellular swelling and brain edema by increasing blood supply and stabilization of cellular membranes.

[0020] In another embodiment of the apparatuses, systems and methods disclosed, the integrated system will implement augmented reality. Augmented reality7, in general, is an interactive experience of a real -world environment where the objects that reside in the real world are enhanced by computer-generated perceptual information, including visual. This generally involves three basic features: a combination of real and virtual worlds, real-time interaction, and accurate 3D registration of virtual and real objects.

[0021] Here, the integrated system can provide an augmented-reality view to the neurosurgeon of the patient’s brain, and the location, shape and contours (among other things) on a real-time and instantaneous basis. The hardware components generally needed to implement augmented reality can include but are not limited to: a processor, display, sensors and input devices. Various technologies can be used in augmented reality rendering, including optical projection systems, monitors, handheld devices, and display systems, which are worn on the human body.

[0022] One such device, called a head-mounted display, is a display device worn on the forehead, such as a harness or helmet-mounted. These devices place images of both the physical world and virtual objects over the user's field of view. Modem devices of this type often employ sensors for six degrees of freedom monitoring that allow the system to align virtual information to the physical world and adjust accordingly with the user’shead movements. Augmented reality displays included in the integrated systems disclosed can include devices resembling eyeglasses and goggles.

[0023] As mentioned above, there is a desire for precision during the surgical procedure. The neurosurgeon desires to be able to precisely “see” inside the brain to visualize the clots location and boundaries, but also to precisely guide the tools being inserted into the brain and into the clot so as to remove only that which is desired to be removed, without damage to surrounding material. This of course requires a very “steady hand” by the neurosurgeon. Even very slight unwanted movement of the inserted surgical tools can cause a less-than-desired result. Such unwanted, inadvertent movement of the surgical tool could be caused when the neurosurgeon turns his or her head to look at a video monitor or other image. To avoid the necessity of such movement, one embodiment of the apparatuses, systems and methods disclosed can include video goggles and / or smart glasses, in which the images (real and / or augmented) that the neurosurgeon needs or wants to view during the procedure can be displayed on the goggles or glasses such there is no need for the neurosurgeon to move his or her head at all during the critical portions of the procedures.

[0024] Another embodiment of the apparatuses, systems and methods disclosed can include robotic technology7. In general, robotic surgery may involve surgical procedures using robotic systems. In the case of robotically-assisted minimally-invasive surgery, instead of directly moving the instruments by hand while holding onto the instrument, the surgeon will ty pically use one of two methods to control the instruments: direct telemanipulation, or computer control, which allows the surgeon to perform the normal movements associated with the surgery. The robotic arms carry out those movements using end-effectors and manipulators to perform the actual surgery.

[0025] In computer-controlled systems, the surgeon uses a computer to control the robotic arms and its end-effectors, though these systems can also still use telemanipulators for their input. One advantage of using the computerized method is that the surgeon does not have to be present, leading to the possibility for remote surgery.

[0026] The apparatuses, systems and methods disclosed will provide to the neurosurgeon features and functions needed for a surgical procedure in a fully integrated package that will allow for efficient and effective remove of the clot. In preferred aspects, this is accomplished without the need for a craniotomy - from initial assessment of the clot, its size, location and status, to planning of the surgical procedure (from scalp incision to trajectory' and depth of insertion of the cannula, to controlled addition and removal oftemperature-controlled fluid to the clot site, to precise and controlled removal of the clot, to confirmation of desired removal, to cauterization - and all done with real time visualization on adjacent video monitors that will allow the surgeon to “see’’ inside the brain.

[0027] In one aspect, an intracranial clot locating, evaluation and removal system comprises a control unit for controlling at least the functions of suction for removal of the clot and irrigation of the intracranial clot location; an elongate obturator encased in a peel-away sheath having a desired interior and exterior diameter, such that after the obturator has been fully inserted into the proper intracranial position, said obturator can be removed, leaving said sheath in place creating a stable pathway to the intracranial clot location; an elongate cannula sized and shaped to have an exterior diameter that mates with the interior diameter of said sheath such that said cannula can be inserted easily and snugly into said sheath to a position wherein the distal end of said cannula has access to said clot; said cannula having multiple channels extending the length of said cannula, one or more of said channels being used for introduction of a clot removal device, for evacuation of the clot material, and for irrigation of the intracranial clot location; a clot removal device operatively attached to said control unit, said clot removal device having body and a distal tip portion, said device being sized and shaped to be insertable through one of said channels within said cannula to a position wherein said distal tip portion of said cannula has access to said intracranial clot; and said distal tip portion of said cannula being capable of articulation relative to said body such that said distal tip portion can be moved to a position that is at an angle relative to the longitudinal centerline of said body.

[0028] The system according to this aspect or according to other aspects and embodiments described elsewhere in this specification may further comprise one or more of the following features.

[0029] The distal tip portion of said cannula may include a visual scope that produces a real time video image, and a video monitor that displays the video image relayed from said visual scope, thereby allowing the surgeon to obtain a 360-degree view of said intracranial clot and clot location before and after removal of said clot by rotation of said distal tip portion of said cannula.

[0030] The cannula of said clot removal device may include means for monitoring fluid pressure within said clot location.

[0031] The cannula or said clot removal device may include means for monitoring temperature within said clot location.

[0032] The cannula of said clot removal device may include means for monitoring oxygen levels within said clot location.

[0033] The cannula may include a channel for insertion of a device used to cauterize brain blood vessels during and after removal of said clot.

[0034] In another aspect, an elongate combination obturator and clot removal device has a hollow elongate body with an atraumatic distal tip which functions as an obturator for gaining access to said intracranial clot; said elongate body has an exit port in close proximity to said distal tip; said hollow elongate body has a clot removal device with an articulating distal tip that can be caused by the surgeon to extend outwardly from said exit port.

[0035] In another aspect, an intracranial device for removing blood or tissue from a patient comprises a tubular body having a proximal end and a distal end, the distal end comprising a flat surface and an angled surface; a first lumen extending from the proximal end to the distal end of the tubular body, a proximal end of the first lumen configured to be coupled to a negative pressure source; a second lumen extending from the proximal end to the distal end of the tubular body, a distal end of the second lumen terminating at least partially at the angled surface, the second lumen configured to slidably receive one or more additional instruments, the one or more additional instruments comprising one or more of an ultrasound probe and a hemostasis tool; a third lumen extending from the proximal end to the distal end of the tubular body, a distal end of the third lumen terminating at least partially at the flat surface, the third lumen configured to accommodate an imaging component; and a fourth lumen and a fifth lumen each extending from the proximal end to the distal end of the tubular body, proximal ends of the fourth lumen and the fifth lumen configured to be coupled to one or more irrigation sources, the fourth lumen defining a first irrigation path and the fifth lumen defining a second irrigation path, the fourth and fifth lumens located on opposite sides of the third lumen and distal ends of the first and second irrigation paths positioned at an angle to a longitudinal axis of the tubular body such that, when in use, irrigation jets exiting the first and second irrigation paths cross each other at a location directly in front of the distal end of the third lumen.

[0036] The system according to this aspect or according to other aspects and embodiments described elsewhere in this specification may further comprise one or more of the following features.

[0037] The device may further comprise a control system configured to control the negative pressure source, the scope, the irrigation source, and the one or more of the ultrasound probe and the hemostasis tool.

[0038] The device may further comprise a first processor configured to control the negative pressure source, a second processor configured to control the ultrasound probe, a third processor configured to control the scope, a fourth processor configured to control the hemostasis tool, and a fifth processor configured to control the irrigation source.

[0039] The irrigation source may include a saline pump.

[0040] The negative pressure source may include a vacuum pump.

[0041] The hemostasis tool may be a cautery' tool.

[0042] In another aspect, an intracranial device for removing blood or tissue from a patient comprises a tubular body may comprise a proximal end configured to be positioned outside of the patient and a distal end configured to be advanced through a skull of the patient; a plurality of aspiration lumens extending from the proximal end to the distal end of the tubular body; a multipurpose lumen extending from the proximal end to the distal end of the tubular body configured to removably receive one or more auxiliary tools, an imaging component at the distal end of the elongate body; and a plurality of irrigation ports at the distal end of the tubular body.

[0043] The system according to this aspect or according to other aspects and embodiments described elsewhere in this specification may further comprise one or more of the following features.

[0044] The aspiration lumens can include an angled or tapered opening at distal ends thereof, and the imaging component may be positioned distal to the angled or tapered opening of the aspiration lumens.

[0045] The distal end of the tubular body may include a flat surface and an angled surface; and the imaging component and the irrigation ports may be positioned at the flat surface and distal ends of the aspiration ports and a distal end of the multipurpose lumen is positioned at the angled surface.

[0046] The distal end of the tubular body may comprise a tapered distal tip, and the imaging component may be positioned at a distal end of the tapered distal tip and distal ends of the aspiration lumens, a distal end of the multipurpose lumen and the irrigation ports may be positioned along tapered surfaces of the tapered distal tip.

[0047] The multipurpose lumen may extend centrally through the tapered distal tip and the imaging component, distal ends of the aspiration lumens, and the irrigation ports may be positioned along tapered surfaces of the tapered distal tip.

[0048] One or more auxiliary tools may be advanceable through the multipurpose lumen and beyond the distal end of the tubular body.

[0049] The auxiliary tool may include an ultrasound device.

[0050] The auxiliary tool may include a cautery device.

[0051] One of the irrigation ports may be configured to rinse the imaging component.

[0052] One of the irrigation ports may be configured to disrupt a clot.

[0053] The device may further comprise a handpiece at the proximal end of the tubular body, and may further comprise fiducial markers on the handpiece.

[0054] The device may further comprise a control system configured to control negative pressure applied through the aspiration lumens; deliver irrigation through the irrigation ports; and control operation of the one or more auxiliary’ tools.

[0055] The device may further comprise a display to display an image taken from the imaging component.

[0056] The device may further comprise a second display to display an ultrasound image taken from an ultrasound device advanced through the multipurpose lumen.

[0057] In another aspect, a method of removing blood or tissue in or around a brain of a patient comprises delivering an aspiration device through a skull of a patient, the aspiration device comprising an imaging component at a distal end of the aspiration device, one or more aspiration lumens, and a multipurpose lumen; directing the aspiration device to a target site in the patient while displaying an image taken by the imaging component; and with an ultrasound device extending through the multipurpose lumen, aspirating blood or tissue from the target site through the one or more aspiration lumens while displaying at least an ultrasonic image taken by the ultrasound device.

[0058] The method according to this aspect or according to other aspects and embodiments described elsewhere in this specification may further comprise one or more of the following features.

[0059] The method may further comprise removing the ultrasound device from the multipurpose lumen, introducing a hemostasis tool or cautery device into the multipurpose lumen, and operating the cautery' device to cauterize tissue.

[0060] Aspirating blood or tissue through the one or more aspiration lumens may comprise aspirating a blood clot.

[0061] The image taken by the imaging component and the ultrasonic image may be displayed on one or more displays.

[0062] The one or more aspiration lumens may provide suction at the distal end of the aspiration device by a negative pressure source connected to a proximal end of the aspiration device.

[0063] The method may further comprise tracking positioning of the aspiration device with a neuronavigation system, wherein fiducial markers are positioned on a handpiece of the aspiration device.

[0064] In another aspect, an intracranial device for removing blood or tissue from a patient comprises a tubular body having a proximal end and a distal end, the distal end comprising a flat surface and an angled surface and a plurality of lumens extending from the proximal end to the distal end of the tubular body, at least one of the plurality' of lumens terminating at the flat surface and at least one of the plurality of lumens terminating at the angled surface.

[0065] Other advantageous aspects and benefits of the apparatuses, systems and methods disclosed will be apparent to those skilled in the art. Nothing stated above is intended to limit the scope of the protection provided for the inventive concepts which are disclosed herein. Herein, the words “hemorrhage,” “hematoma,” “clot” and the acronym ICH are used interchangeably to refer to blood, whether clotted or not, that is present in an unwanted part of the brain. The word “tumor” is used in its ordinary' and customary' way. The system and methods herein described for removal of a clot can also be utilized for removal of brain tumors, although it will be apparent to those skilled in the art that tumorremoval-specific tools may also be utilized in addition to those described below.DESCRIPTION OF THE DRAWINGS

[0066] In the drawings, which are not necessarily to scale, like numerals may describe similar components in different views. Like numerals having different letter suffixes may represent different instances of similar components. The drawings illustrate generally, by way of example, but not by way of limitation, various embodiments discussed in the present document.

[0067] FIG. 1 is a graphic representation of the patient laying on the operating table, showing the patient’s head, the approximate location of the brain within the patient’s skull, and a representation of a blot clot within the brain.

[0068] FIG. 2 illustrates a perspective view of an embodiment of an intracranial hematoma treatment system with a patient.

[0069] FIG. 3 illustrates a close up view of an embodiment of a clot removal system including placement of certain components.

[0070] FIG. 4 illustrates a close up view of an embodiment of a clot removal system including placement of additional and alternative components to those from FIG. 3.

[0071] FIG. 5 illustrates a close up view of an embodiment of a clot removal system including placement of additional and alternative components to those from FIG. 3.

[0072] FIG. 6 illustrates a close up view of an embodiment of a clot removal system including placement of additional and alternative components to those from FIG. 3.

[0073] FIG. 7 illustrates a close up view of an embodiment of a clot removal system including placement of additional and alternative components to those from FIG. 3.

[0074] FIG. 8 illustrates a close up view of an embodiment of a clot removal system including placement of additional and alternative components to those from FIG. 3.

[0075] FIG. 9 illustrates a close up view of an embodiment of a clot removal system including placement of additional and alternative components to those from FIG. 3.

[0076] FIG. 10 illustrates a close up view of an embodiment of a clot removal system including placement of additional and alternative components to those from FIG. 3.

[0077] FIG. 11 illustrates a close up view of an embodiment of a clot removal system including placement of additional and alternative components to those from FIG. 3.

[0078] FIG. 12 illustrates a close up view of an embodiment of a clot removal system including placement of additional and alternative components to those from FIG. 3.

[0079] FIG. 13 illustrates a close up view of an embodiment of a clot removal system including placement of additional and alternative components to those from FIG. 3.

[0080] FIG. 14 illustrates a close up view of an embodiment of a clot removal system including placement of additional and alternative components to those from FIG. 3.

[0081] FIG. 15 illustrates a close up view of an embodiment of a clot removal system including placement of additional and alternative components to those from FIG. 3.

[0082] FIG. 16 illustrates a peel-away sheath, obturator, and neuronavigation markers.

[0083] FIG. 17A illustrates a perspective view of a multi-lumen cannula.

[0084] FIG. 17B illustrates an alternative perspective view of a multi-lumen cannula.

[0085] FIG. 18A illustrates a perspective view of an obturator and cannula.

[0086] FIG. 18B illustrates an alternative perspective view of an obturator and cannula.

[0087] FIG. 19 illustrates a close-up view of an obturator and cannula to be inserted into the patient’s head.

[0088] FIG. 20A illustrates the obturator and cannula inserted into the patient’s head.

[0089] FIG. 20B illustrates an alternative view of the obturator and cannula inserted into the patient’s head.

[0090] FIG. 21A illustrates a perspective view of an obturator and cannula with the peel-away sheath.

[0091] FIG. 21B illustrates an alternative perspective view of an obturator and cannula with the peel-away sheath.

[0092] FIG. 22 illustrates the distal end of the clot removal device in an articulated state.

[0093] FIG. 23 illustrates a front view of the distal end of the clot removal device.

[0094] FIG. 24 illustrates the clot removal device inserted into the patient’s head.

[0095] FIG. 25 is a close-up image of the clot removal tool rotated and inserted into the head of the patient.

[0096] FIG. 26 is a close-up image of the clot removal tool rotated and inserted into the head in an alternative position within the patient.

[0097] FIG. 27 illustrates an alternative embodiment of the distal end of the clot removal device.

[0098] FIG. 28 illustrates a perspective view of a patient with the clot removal system, according to some embodiments.

[0099] FIG. 29A illustrates a perspective view of a patient with an alternative embodiment of the clot removal system, according to some embodiments.

[0100] FIG. 29B illustrates another view of the clot removal system from FIG. 29A, according to some embodiments.

[0101] FIG. 30 illustrates a close-up view of an embodiment of the clot removal system in use on a patient, according to some embodiments.

[0102] FIG. 31A-31F illustrate an embodiment of the clot removal device, according to some embodiments.

[0103] FIG. 32A-32B illustrate an alternative embodiment of the clot removal device with a deflected tip. according to some embodiments.

[0104] FIG. 33A-33C illustrate an embodiment of the distal end of the clot removal device, according to some embodiments.

[0105] FIG. 34A-34C illustrate an alternative embodiment of the distal end of the clot removal device, according to some embodiments.

[0106] FIG. 35A-35F illustrate an alternative embodiment of the distal end of the clot removal device, according to some embodiments.

[0107] FIG. 36A-36B illustrate an alternative embodiment of the distal end of the clot removal device, according to some embodiments.

[0108] FIG. 37A-37C illustrate an alternative embodiment of the distal end of the clot removal device, according to some embodiments.

[0109] FIG. 38A-38B illustrate an alternative embodiment of the distal end of the clot removal device, according to some embodiments.

[0110] FIG. 39 illustrates a control console as part of the clot removal system, according to some embodiments.

[0111] FIG. 40 is a perspective view of a hub as part of a clot removal system.DETAILED DESCRIPTION

[0112] Aspects and exemplifying features of certain systems, devices and methods will now be described with respect to removal of a clot following an aneurysm rupture. It will be appreciated that these systems, devices and methods may be applied to other conditions and for the removal of other types of blood or tissue, and not all of the features described herein are necessary for clot removal or for the removal of other types of blood or tissue.

[0113] In a typical ICH situation, the patient symptoms once an aneurysm has ruptured will be obvious and extreme, such that immediate transfer to the hospital will occur. The patient will typically be admitted via the hospital’s emergency room. The immediate goal will be to stabilize the patient as much as possible. The patient is then sent for imaging, in which an initial CT scan of the head, and an angiogram of the head andneck regions. A neurosurgeon will be consulted and an MRI will also be taken in most cases. The imaging results will show the size and location of the ICH, and will provide the baseline data for treatment, and for use by the neurosurgeon using the apparatuses, systems and methods herein disclosed. The preferred system will work with CT or MRI system or portable CT (O-Arm), with the advantage of the O-Arm being that it can be done real time in the Operating Room and can include augmented visualization. The patient's age, and the location, size and status of the ICH will dictate treatment, including if surgery is required to remove the clot.

[0114] In a preferred embodiment, the system will include integrated neuronavigation, which will initially be utilized for planning the location, orientation and size of the skull skin incision, the size and location of the access hole to be drilled in the skull, and the trajectory and depth for insertion of the cannula. Once these parameters have been determined, the surgery can begin using the embodiments of the disclosed apparatuses, systems and methods, which include hardware and software.

[0115] The hardware components can include an integrated video screen or screens for initial visualization of the clot in-situ via ultrasound or other similar means; an integrated and highly controlled vacuum pump for fluid aspiration, coordinated with an integrated pump system for highly and accurate controlled fluid delivery to the clot site so that fluid being removed is equally offset by the volume of fluid being added to avoid undesired fluid pressure differential in the brain. The apparatus can also include an integrated heat-exchange system to allow cooling and temperature control of the fluids to be delivered into the brain.

[0116] The hardware can also preferably include an integrated fluid oxygenation and oxygen content measurement capability for the fluid being delivered to the brain in either PO2 or SO2. The preferred system will also monitor and control the pH of the fluid being added. An integrated sensing capability will also be preferably included, which will sense, monitor and measure such parameters as pressure, temperature, oxygen levels, fluid delivery and aspiration volumes, vacuum level. A Mayfield three pin head holder (or similar device) will be used to hold the patient's skull in a motionless position, and also for attachment of certain of the hardware components. The har ware will also preferably include integrated control and safety mechanisms to ensure proper operation.

[0117] The hardware components can also include single-use disposable items as well. One component is a dual lumen or multi-lumen cannula that can be 4mm- 12mm in diameter and 6cm to 12cm in length. The lumens provided with the system can bevarious diameters. The working-end tip of the cannula can be rigid or flexible, and can also have steerable tip with varying lengths. The preferred cannula will incorporate sensors for pressure, temperature and oxygen levels, and the sensors can be at tip or along entire body of cannula in varying increments from each other (i.e. l-2cm apart).

[0118] The hardware components can also preferably include an ultrasonic probe for visualization similar to Intravascular Ultrasound (IVUS) technology. The probe can be mounted as fixed probe at the tip of cannula or part of flexible tip. The probe can also be introduced through a large lumen in cannula that can be pushed through the length of the cannula and beyond cannula tip into hematoma via a guidewire type of system. Once the probe is inserted into the cannula to a point where it extends beyond tip of cannula, the cannula lumen can be used for other purpose such as fluid delivery or aspiration of clot or fluid; can also be used for other purposes as required. The ultrasonic probe is connected to a video screen to display and show details of the hematoma, such as visualization of residual contours of hematoma. The objective here is to “see’' the geometry, size, volume, density of clot (i.e.. whether it is entirely or mostly, fluid or of a more solid consistency. The details allow the surgeon to determine the method and tool by which the hematoma will be extracted. The probe will also be able to determine and differentiate the cellular make-up between blood clot and brain tissue.

[0119] A preferred apparatus, system and method can include the ability to circulate continuous compatible hyperosmotic hypothermic 23% NaCl solution (or other desired solutions) through the cannula into the clot site. As mentioned, the fluid delivery and aspiration needs to be controlled, as fluid delivery will not be allowed by the system to exceed fluid aspiration. This will include pressure monitoring integrated to constantly measure the fluid pressure within hematoma. Safety systems will be preferably included to restrict fluid volume delivery not being allowed to exceed fluid volume aspiration. Fluid oxygenation capability will also be preferably integrated into the system. Controlled and monitored, cooling of the fluid may be desirable to offset and dissipate the heat that may be generated at the clot site due to, for example, ultrasound removal of the clot. In addition, the introduction of cooled fluids can help to reduce swelling in the surrounding brain tissue and provide neuro-protection.

[0120] Various clot breakup mechanisms may be integrated into system. The mechanisms provide the ability to dissolve acute and subacute blood clots. Options for the mechanisms include: ultrasonic - mechanism delivered though a lumen in cannula or integrated fixed into cannula tip to break up clot (this will calibrated, controlled andmonitored to differentiate between clot blood cells and brain cells, so that there is controlled and precise aspiration of the clot with only minimal damages to adjacent brain cells). A preferred system may also provide for continuous or intermittent fluid delivery to the clot site to dilute clot and also to cool ultrasonic clot break-up mechanism if heat is generated. Fluid delivery7and aspiration will be controlled and may include integrated safety control that does not allow fluid delivery to be greater than aspiration. A preferred system may continuously measure, monitor and report both volume and pressure of the fluid at the clot site.

[0121] Other mechanical clot break-up systems can be included. For example, high speed roto-rooter type or burr tip technology that has cell differentiation recognition capability7to assess blood cells (clot material) vs brain cells; or an Archimedes screw type of mechanism that can pull as well as potential break up clot within cannula; or a brush ty pe system - a spiraled brush system along a catheter that spins and pulls clot. Brush can be soft or metallic to break or chop up clot.

[0122] The software that is integrated into a preferred system interfaces with a Neuronavigation system and CT / MRI imaging to provide instantaneous and precise feedback on positioning of the cannula as it is being navigated through the access hole in the skull, into the brain, then into the clot, and includes an indication of the cannula’s location within clot. The software can also provide instantaneous feedback on the amount of clot being removed, as that is compared against the baseline data that was captured from the initial imaging (CT and MRI) of the patient’s skull.

[0123] Referring now to Figure 1, a graphic representation of the patient laying on the operating table, showing the patient's head, the approximate location of the brain within the patient’s skull, and a representation of a blot clot within the brain. A patient 10 is shown lying on a ty pical surgical table 12, having been previously prepped for brain surgery. In a typical brain surgery, the patient’s head would normally7be immobilized against the table 12 by means of a strap or other similar device (not shown). This patient’s skull 14 encases the patient’s brain 16. in which resides the to-be-removed clot 18.

[0124] Figure 2 is a graphic representation of one embodiment of the system’s primary’ components shown in conjunction with the patient on the operating table. Figure 2 shows the same prepped-for-surgery patient 10 prone on the table 12 along with certain of the other components of the overall system. The alignment mount 20 is adjustably attached to the table 12 by means of bar 22. The alignment mount 20 will be used for controlled and exact insertion and use of the main tools to access and then remove the clot;the alignment bushing 24 that is located in and locks into the upper end of the mount 20, and through which the various tools will be inserted for precise location and angle-of- insertion control relative to the brain 16 of patient 10, and the location of the clot 18 within the brain.

[0125] A multi-handle rack 26 is movably attached to bar 22. The upper portion of the rack 26 is preferably outfitted with open collars 28 into which the handles of the various tools that the surgeon will use or may want to use can be located in easy reach by the surgeon. For example, as shown in this Figure 2, the multi-handle rack 26 is holding the handle portion 30 of the intracranial clot-removal device 32.

[0126] The clot removal device 32 is shown in Figure 2 in which the handle portion 30 of that device is residing within one the rack collars 28. The clot removal device 32 is connected to the control box 34 seen in Figure 2 via connection tube 36. The control box 34 can be of any standard size, shape, configuration and functionality to provide and control the various devices that are being used with the system, such as device 38, which will also be held in one of the collars 28 in rack 26. The control box 34 in a preferred embodiment can be provided for adjustable suction pressure, irrigation pressure, irrigation temperature ambient fluid pressure within the brain, and the controlled inflow and outflow of fluid so as to maintain a proper fluid pressure within the patient’s brain. The control box 34 can also monitor the amount of clot material removed. It can also provide for other devices and functions such as 02 sensing, for example. The system can also include a monitor 40 which will be attached to a monitor mount 42 that is attached in this embodiment to the surgical table 12, and can be adjusted so that the monitor 40 can located as desired by the surgeon. It is preferred that the monitor (or monitors as the system can provide for multiple monitors) be located in such a way that the surgeon will have easy sight-line access so as to eliminate the need for the surgeon to move his or her head in order to view the monitor 40, thereby eliminating unwanted movement that might be transmitted to the working end of the devices once inserted into the patient’s brain 16.

[0127] Figure 3 is a graphic representation as in Figures 1 and 2, but with an isolated view of three of the systems components - an alignment mount (attached to the surgical table) to be used to precisely guide the cannula for insertion and the neuronavigation alignment probe which will also be inserted into the alignment mount’s bushing. This figure depicts initial set-up of certain components in conjunction with the patient positioned for surgery’. The initial set up of the system as shown in Figure 3 includes the neuronavigation alignment probe 44 and its affixed position markers 46.Neuronavigation is the set of computer-assisted technologies used by neurosurgeons to guide or "‘navigate” within the confines of the skull during surgery. There are many such suitable systems available commercially, and the apparatus, system and methods herein described and claimed can be used with any of them. The position markers 46 are used by the standard and known neuronavigation software to determine the optimum path for insertion of the obturator device into the patient's brain to gain access to the clot. The probe 44 is inserted into the alignment bushing 24.

[0128] Figure 4 is a graphic representation as in Figure 3, showing the neuronavigation tool inserted into the alignment mounts bushing. The arrows depict the rotational movement to determine the desired access pathway through the patient’s skull into the clot. Figure 5 is similar to the preceding Figures, but in this figure the craniotome (a cranial drill) is used to drill an access port (or burr hole) for the system’s components that will be inserted into the patient’s brain. Here, craniotome is showTi positioned for insertion into the bushing of the alignment tool and then for precisely controlled drilling of the access port in the patient’s skull.

[0129] As best seen in Figures 4 and 5, once the neuronavigation alignment probe 44 has been inserted into the alignment bushing 24, the adjustable mount 20 is rotatable along multiple axis to achieve the optimal access pathway as determined using the neuronavigation software. Once that optimal pathway is determined and the adjustable mount 20 is locked into place, the next step in the procedure is to drill a small access port or burr hole into the patient’s skull using a craniotome 48.

[0130] Figure 6 is similar to Figure 5, but in this figure the access port or burr hole has been drilled, and the craniotome removed. The system’s obturator (which is used to create a pathway to the clot (or tumor) through the folds of the brain without damaging the brain) is positioned for insertion first into the alignment tool’s bushing, and then through the access port in the patient’s skull, and then into the depicted blood clot (or tumor). Figure 7 is similar to Figure 6, but shows the obturator (and in this embodiment, a surrounding peel-away sheath now fully inserted into the brain such that the tip of the obturator is located within or immediately adjacent to the to-be-removed clot or tumor. Figure 8 is similar to preceding figures, but in this figure the obturator has been removed, leaving the peel-away sheath in-situ within the brain to maintain the pathway to the close (or tumor) after the obturator has been removed.

[0131] Once the burr hole (not shown) has been created, the next step is to create an access pathway within the patient’s brain 16 to the clot to be removed, and to doso without injuring healthy brain tissue. An obturator 50 is used for this procedure. In a preferred embodiment, the obturator 50 will first be inserted into a peel-away sheath 52 as best seen in Figure 6. The obturator 50 and sheath 52 are then inserted through the alignment bushing 24 on the alignment mount 20 and is then inserted through the burr hole into the patient’s brain until the tip of the obturator 50 reach the clot 18 to be removed, as shown in Figure 7. The peel-away sheath 52 will remain stationary within the patient’s brain even after the obturator 50 is removed, and will provide for a reusable passageway to the clot location for other devices as hereinafter described. This is best seen in Figure 8. It is noted that the surgeon can leave the sheath 52 inserted throughout the entire procedure, or remove it, at his or her choice.

[0132] Figure 9 is similar to the preceding figures, showing the system’s cannula (in this embodiment, having multiple lumens or channels that run the entire length of the cannula) about to be inserted into the patient’s through the peel-away sheath that maintained the pathway to the clot after removal of the obturator. Figure 10 is similar to Figure 9. showing the multi-lumen or channel cannula now fully inserted into the peel- away sheath and into position within the patient’s brain.

[0133] At this point in the procedure, a preferred embodiment of the cannula 54 is readied for insertion through the peel-away sheath 52 into the patient’s brain 16 and down to and into the to-be-removed blood clot 18. As best seen in Figure 9, the cannula 54 is sized and shaped so that it fits snugly within the peel-away sheath 52 but can be slid easily within it. The completed procedure whereby the cannula 54 has been fully inserted into the peel-away sheath 52 is seen in Figure 10. As will be discussed in more detail below with reference to other figures, a preferred cannula 54 will have a number of elements and features. At this point in the procedure, an access pathway has been created to the clot 18 which will be used for the various tools and devices that the surgeon will need to insert into the patient’s brain in order to remove the clot.

[0134] Figure 11 is similar to Figure 10, showing the distal end of the clot removing device now positioned for insertion through the cannula (which has remained within the peel-away sheath) and into position within the patient’s brain to begin clot removal. Of course, in actual practice and use of the described system and methods, these various components that are inserted into the patient’s brain can be guided either manually by the surgeon, or robotically using known techniques (neither of which are shown in the figures). Figure 12 is similar to Figure 11, showing that the clot removing distal end of the clot removing device has been fully inserted through the cannula and is now positionedwithin the clot in the patient’s brain to begin clot removal. The distal end of the clot removal device 32 can be inserted into the to-be-removed clot 18. As described above, there has now been created an access pathway to the clot 18, and that pathway is through the cannula 54 that resides within the peel-away sheath 52, which is held in position by the alignment bushing 24 that his held in position within the alignment mount 20. As best seen in Figure 11, a preferred clot removing device 32 will have a handle 56 to which a tube 58 is attached, and at the distal end of the tube is attached the device that will accomplish the clot removal. As shown in Figure 12, the clot removal device 32 has been inserted into the clot 18 but no portion of the clot has yet been removed. Typical clot sizes are 50 to 70cc in volume. What is shown in Figure 11 is an approximately 50cc clot. The clot removal device can include functions for aspiration, imaging, cauterizing, etc. When inserted at the clot site, the clot removal device may be directed to a position with imaging components. Aspiration may be applied for the removal of blood, tissue, or clot material. Other functions of the clot removal device may be used for the removal of the clot. Various embodiments and ways of using the clot removal device 32 are described in further detail below starting at Figure 31 A.

[0135] Figure 13 is similar to the preceding figures, showing that the clot removal operation has been completed and the clot removal device has now been extracted from the patient’s brain. It is noted that the cannula within the peel-aw ay sheath remain in- situ. Figure 13 depicts the clot size after the removal procedure is completed, which is now approximately 5cc. It is typical in such operations that the entire clot is not removed, otherwise hemorrhaging at the clot site may resume. Once the desired amount of clot material has been removed, the clot removal device 32 is removed from the cannula 54 as is depicted in Figure 13. It is noted that the cannula 54 remains in place.

[0136] Figure 14 is similar to the preceding figures, but shows that that after the clot removal device has been extracted, other tools can be inserted through the cannula into the patient’s brain, for example cautery, another scope, or an ultrasound probe can be inserted through one of the functional channels in the cannula into the patient’s brain. It should also be noted that because a preferred embodiment of the cannula will have multiple channels or lumens, other such devices could be used before the clot removal device is extracted. Figure 15 is similar to preceding figures, showing the situation in which all intracranial procedures have been completed, and the cannula and peel-away sheath have been removed.

[0137] Because the cannula 54 has remained in place, other devices can be used by the surgeon as desired and inserted through the cannula 54 as shown in Figure 14. Suchother devices could include (and not limited to) a visual scope, an ultrasound probe, device to cauterize the wound site within the brain if hemorrhaging continues. These other devices 59 can be inserted through a main channel within the cannula 54. In addition, because the cannula 54 can include multiple channels (as will be described in more detail below), one or more of these other devices can be inserted through the cannula 54 and used simultaneously with the clot removal device 32. In other words, the surgeon will have the option of using such other tools before or after the clot removal device 32 is removed. Once all procedures within the patient’s brain are concluded, the cannula 54 and peel-away sheath are removed, and the burr hole dressed and sealed to prevent leakage of any cerebral / spinal fluid. Sealing around the peel-away sheath at the burr hole site during the procedure is also preferred to prevent such leakage of the cerebral / spinal fluid.

[0138] Figure 16 depicts the peel-away sheath, the obturator and the neuronavigation positional marker. One of the embodiments of the obturator 50 is seen in Figure 16. As shown there, body 60 mates with the interior radius of the body portion 62 of the peel-away sheath 52. The sheath 52 can have a pair of flaps 64 at the proximal end of the sheath for easy peeling away. As shown here, the obturator 50 is equipped with the neuronavigation position markers 46. In the embodiment of the obturator 50 shown here, there is a single channel 64 that extends the entire length of the obturator 50 that will accommodate insertion of a scope (not shown).

[0139] Figures 17A and Figure 17B show two perspective views of the multilumen or -channel cannula which will be inserted into to the patient’s skull. The neuronavigation position markers are also shown attached to the cannula. Preferred alternative embodiments of the cannula 54 are described below . Figures 17A and 17B depict one of the preferred embodiments in perspective views from two different angles. In Figure 17A, the proximal portion 66 of the cannula 54 is visible and shows that this embodiment of the cannula 54 has a main channel 68 that is preferred intended for use with the clot removal device 32; a secondary channel 70 that can be used for example, with the other devices described above, such as a visual scope, ultrasound or cautery; and two side channels 64 that can used for other purposes that the surgeon may desire. As shown in Figure 17B, each of these channels extends the entire length of the cannula 54. In this embodiment, the cannula 54 has a pair of multi-sensor location 72 and 74 which can be used for sensing such things as fluid pressure in-situ, 02 levels, temperature, etc. As also depicted here, this embodiment of the cannula 54 includes the neuronavigation position markers 46 fixedly attached at the proximal end of the cannula 54.

[0140] Figures 18A and 18B show two different views of an alternate embodiment in which the obturator and the cannula are combined into a single component. Here, the component has a soft tip that is used during the obturating step, and behind the soft tip, a side exit port through which the tip of the clot removal device can be extended once the side port of the cannula is within the to-be-removed clot (or tumor). In Figure 18 A the distal tip of the clot removal device is shown in a retracted position within the cannula. In Figure 18B. the distal end of the clot removal device is show extended through the exit port in the cannula. As shown here, the distal end of the clot removal device can be articulated to allow it to protrude though the cannula’s exit port. An alternative embodiment is shown in Figures 18A and 18B, in which an obturator and cannula are combined into a single device 76. This device 76 preferably has a single channel 78 into which another embodiment of clot removal device 34 can be inserted. This embodiment of the combined obturator / cannula device 76 also includes the fixedly attached neuronavigation position markers 46 at the proximal end of the device 76. The distal end of the obturator / cannula device 76 is equipped with a soft tip 80 that is for the obturating procedure. When this obturator / cannula device 76 is used it remains inserted in the patient’s brain 16 for the entire procedure (whereas a separate obturator is removed after the pathway to the clot is established). Because the soft tip 80 of the obturator / cannula device 76 remains in-situ for the duration of the surgical procedure, this device 76 is equipped with a side exit port 82, the purpose of which will be described below. It is also preferred equipped with an ultrasound transmitter / receiver 84 and can also be equipped with a multi-sensor location (not shown) on the other side of the tip 80.

[0141] This combined obturator / cannula device 76 can be used with a specialized clot removal device 86 as seen in Figures 18A and 18B, which shows the specialized clot removal device 86 fully inserted and residing in the device 76 in Figure 18A, and in a fully -inserted position in Figure 18B, wherein the tip 80 is in an extended and articulated position.

[0142] Figure 19 depicts the combination obturator / cannula with inserted clotremoval tool in position to be inserted into the patient’s skull. As shown in Figure 19, this combined obturator / cannula device 76 and specialized clot removal device 86 can be inserted together through the alignment bushing 24, or the combined obturator / cannula device 76 can be inserted first through the alignment bushing 24, and then the specialized clot removal device 76 inserted once the device 76 has been partially or fully inserted into the patient’s brain 16.

[0143] Once the two devices 76 and 86 have been inserted into the to-be- removed clot 18, the distal tip 88 of the device 86 can be articulated by the surgeon to extend laterally outwardly from the exit port 82. The surgeon can then rotate the combined devices 76 and 86 to cause the extended tip 88 to rotate within the clot 18.

[0144] Figures 20A and 20B depict the distal ends of the combined obturator / cannula / clot-removal device inserted into the clot within the patient’s brain. The distal tip of the clot-removal tool is extended through the exit port so that the tip is outside and extending laterally from the cannula. The rotational arrow in Figure 20B depicts how clot removal device can be rotated so that its extended tip can rotate within the clot for efficient and effective breaking up and removal of the clot. Figures 20A and 20B show the combined cannula with the obturation tip in place within the to-be-removed clot and position to begin the removal step, and with distal end of the clot removal device in the extended position outside and lateral positioned relative to the cannula. Figure 20A shows the tip of the clot removal tool pointed posteriorly, and in Figure 20B it is pointed anteriorly. This rotational movement is created by rotation the cannula as shown by the directional arrow in Figure 20B. As shown in Figure 20A, the distal tip 88 is facing posteriorly in the clot 18, and in Figure 20B, it is facing anteriorly within the clot. This laterally -extending and rotatable tip 88 allows for access to and viewing of the entire clot 18, and then more effective removal of the clot 18.

[0145] Figures 21A and 21B show another preferred embodiment of the combined obturator / cannula device which would be inserted into the patient’s brain through the peel-away sheath. In Figure 21 A, the distal tip is show n in an articulated position (which would be used after the tip is inserted into the to-be-removed clot); and in Figure 21 B it is shown in a non-articulated position (which would be used initially when the device is first inserted into the patient’s brain). Another alternative preferred embodiment of a combined obturator / cannula device 90 is shown in Figures 21A and 21B in two perspective views. This device 90 eliminates the need for the peel-away sheath 52 and for a separate obturator 50. This device 90 is preferably equipped with transmitter / receiving port 92, and has a distal tip 94 that can be articulated such that once inserted into the clot 18, the tip 94 can be brought into a curved position by the surgeon. As this device 90 will also act as the obturator device, the tip 94 will preferably be of a soft material.

[0146] Figure 22 is a close-up view' of the distal end of the clot removal device in an articulated state, and shows the various access ports that can be included in the clot removal device. Figure 23 is a close-up view of the distal end of the clot-removal devicelooking directly at the very' end of the device, which depicts the various components that can be included, such as a scope, a multi-sensor location, and irrigation channels and evacuation channels, for examples. Figures 22 and 23 show more detail as to the cannula portion of combined obturator / cannula device 90. As shown there, the distal tip 94 of the combined obturator / cannula device 90 will include the following elements: a visual scope 96 located that the very distal end of the tip 94; multiple suction / evacuation channels 98 for removal of clot 18 material; multiple irrigation channels 100 for delivering fluid into the clot site; and a functional channel 102 that can used for other devices as described above.

[0147] Figure 24 shows a situation in which the clot-removal tool depicted in Figures 22 and 23 is inserted into the clot through the alignment bushing, and with the distal end of the device not yet articulated. Figures 25 and 26 show the clot-removal tool depicted in Figures 22 and 23 inserted into the clot through the peel-away sheath and the alignment bushing, and with the distal tip of the device not yet articulated. The rotational arrow' in Figure 26 shows that the tool has been rotated within the clot between that shown in Figure 25. Figures 24, 25 and 26 show this alternative preferred embodiment of a combined obturator / cannula device 90 positioned such that the distal tip 94 is located within the clot 18 upon insertion in the un-articulated state (Figure 24), then with the distal tip 94 in an articulated state, facing posteriorly (Figure 25), and then with the distal tip 94 in an articulated state, facing anteriorly (Figure 25). By rotating the shaft of the device 90 (which can be rotated 360 degrees), the surgeon can view the entire clot.

[0148] Figure 27 show s an alternative embodiment of the distal end of the clot removing device in which a helical auger- t pe, rotatable element is incorporated into the end of the clot removing device to facilitate the removal of the clot material. There are numerous other additional elements that can be added to the channels in the cannula. One such additional element is shown in Figure 27, which is a high-speed, helical, auger type device 104 situated in a suction / evacuation channel 98. During the suction activity, this high-speed auger device 104 can be caused by the surgeon to rotate in so as to both aid in breaking up the clot material and forcing the blot material up and out of the suction / evacuation channel 98.

[0149] Referring to Figure 28, a perspective view of another embodiment of a clot removal system is depicted with a patient. This clot removal system may incorporate one or more features of any of the devices, systems and methods already described, and one or more of the features to be described as part of this system may be incorporated intothe previously described devices, systems and methods. The clot removal system may be located in a surgical suite 110. The patient 112 may have a blood clot 113 or other blood or tissue needing removal. As part of the procedure, the patient may be placed on an operating table 111 to prepare the patient for removal of the blood clot 113. Removing the blood clot 113 may occur though the clot removal system as described herein. The clot removal sy stem may include a monitor stand 115. The monitor stand 115 may be connected to the operating table 111. Alternatively, the monitor stand 115 may be standalone or coupled to other devices of the system. A monitor 116 may be coupled with the monitor stand 115. The monitor 116 has a display for visualizing the clot site based on images, for example, from an ultrasound or other suitable imaging techniques. The monitor 116 and / or monitor stand 115 may be adjustable to allow the surgeon to work from different positions or heights. Images on the monitor 116 may include those received from an ultrasound, a camera, or other imaging component within the system. The clot removal system may include the clot removal device 200. The clot removal device 200 may be a handheld device with aspiration. The clot removal device may be inserted into the patient 112. The device 200 may include an aspiration or suction canister 114 to collect material removed from the patient 112. The clot removal system may also include a control console 300 that provides the surgeon control of one or more components of the system.

[0150] Figure 29A is a perspective view of an alternative embodiment of the clot removal system. Figure 29B is an alternative view of the clot removal system from Figure 29A. The system may have a first monitor 1 16. The system may have a second monitor 117. Either or both of the first and second monitors may be positioned on the monitor stand 115 to improve visibility' and efficiency for the surgeon.

[0151] Features of the clot removal system of Figure 28 can be incorporated into the clot removal system of Figure 29A-29B. Features of the clot removal system of Figures 29A-29B can be incorporated into the clot removal system of Figure 28. In some operating rooms or surgical suites 110 or in alternative clot removal systems, a second monitor 117 may be affixed to the monitor stand 115. A first monitor 116 and a second monitor 117 may allow more display space for multiple imaging components. For example, the first monitor 116 may be used exclusively for an ultrasound device, and the second monitor 117 may display images from a camera in the clot removal device.

[0152] In alternative embodiments, the clot removal system may have one, two, three, or more monitors for use by the operator. The control console 300 may be configured in a number of various ways as will be discussed later in more detail.

[0153] Figure 30 illustrates a zoomed view of various components of the clot removal system. A mount 20 may be used to support the clot removal device. The clot removal device may be positioned near the head of the patient. The clot removal device may be removably placed within the mount 20. The mount 20 can be adjusted or removed from the system altogether. As will be described later, the clot removal device 200 may include an aspiration lumen (see Figure 33A at 408) to remove portions of the clot from the patient. As shown in Figure 30. the aspiration lumen may be in connection with an aspiration canister 114 to collect material.

[0154] Referring now to Figure 31 A, different components of a clot removal device 200 may exist and may work differently in conjunction with different embodiments of the clot removal system. In one embodiment, the clot removal device 200 may be a single-piece handheld cannula with a scope. The scope may be fixed to the cannula. The scope can be used by the operator to navigate through the brain during a procedure to remove the clot from the patient. In some embodiments, the device may include a tubular body 201 and a handpiece 203. The tubular body 201 may include a cannula shaft. The handpiece 203 may be used to support a portion of the device 200 outside the patient during use. The tubular body 201 of the blood clot removal device may have a proximal end 224 and a distal end 210. The proximal end 224 refers to the end of the tubular body 201 that is nearest the operator, and the distal end 210 refers to the end of the tubular body 201 nearest the patient for insertion into the clot site. The distal end 210 of the tubular body 201 may be inserted into the patient.

[0155] In certain embodiments, the handpiece 203 of the clot removal device may have an alignment ring 202 towards the proximal end 224. The alignment ring 202 may be used to orient the tubular body 201. The alignment ring 202 may be used to orient the cannula to the handpiece 203. There may be several components within the tubular body 201, discussed in further detail below, that may require a specific orientation for use by the operator. An alignment ring lock 205 may be positioned on the handpiece 203. The alignment ring lock 205 may be tightened to prevent the alignment ring 202 from turning or adjusting during use. The alignment ring lock 205 may be positioned in various places on the clot removal device so as to not impede with the use of the instrument.

[0156] In certain embodiments, the handpiece 203 may have an auxiliary tool connection 220 that may be connected to components within the tubular body 201. Movement of the auxiliary tool connection 220 may result in movement of the components within the tubular body 201. In Figures 31 A and 31 C, the auxiliary tool 220 is in a retractedposition 221a. The auxiliary tool connection 220 may be in the retracted position 221a to keep the auxiliary tool within the tubular body 201 of the device. The distal end 210 of the clot removal device 200 may have no components protruding when the auxiliary tool connection 220 is in the retracted position. Movement of the auxiliary tool connection 220 may be confined to a fixed amount on the handpiece as a safety mechanism or to keep the auxiliary tool from protruding too far from the distal end 210. When the auxiliary tool connection 220 component is no longer able to advance on the handpiece 203, the internal component may be prevented from protruding further from the distal end 210. In some embodiments the internal components may only protrude from the distal end a maximum of about 5 mm. Translation of the auxiliary tool 222 may directly correlate to the amount of the internal component that protrudes from the distal end. As illustrated later, see Figure 33B at 404, medical devices removably inserted into a multiuse lumen 404 may extend past the end of the distal face of the tubular body 201. Extending past the distal face may provide access to part of the clot site without advancing the entire distal end of the clot removal device 200. The clot removal device 200 may contain a spring mechanism. A spring mechanism may be used to prevent instruments in the multiuse lumen 404 from extending too far past the distal end. The maximum amount an instrument may extend past the distal end is approximately 10 mm before the safety mechanism stops the manual advancement of the instrument.

[0157] Figures 3 IB, 3 ID and 3 IF illustrate the clot removal device with the auxiliary tool connection in an extended position 221 b. The auxiliary tool connection 220 being in an extended positioned 221b may cause the auxiliary tool 222 to protrude out of the distal end of the device. When the auxiliary tool connection 220 is shifted towards the distal end 210. an auxiliary component 222 within the tubular body 201 may protrude distally from the distal end 210. Auxiliary component 222 may be a hemostasis tool or cautery device, an ultrasound transducer, or other medical tool positioned within the tubular body 201, discussed in further detail below.

[0158] The clot removal device 200 may include components for neuronavigation. For example, fiducial markers, neuronavigation markers, or imaging references 204, may be integrated into the handpiece 203. The imaging references 204 may extend from a top portion of the clot removal device 200. The imaging references 204 may be positioned towards the proximal end 224. The imaging references 204 may be adjustable, such as on a vertical axis towards and away from the handpiece 203 of the device, according to the placement of the device and how the user wishes to align them.The imaging references 204 may be turned clockwise or counterclockwise or tilted. In certain embodiments, the imaging references 204 may protrude from the top surface of the clot removal device 200 and split into three (or any other suitable number of) prongs 216 that are parallel to the plane of the tubular body 201. Each prong 216 may contain a reference to help orient the position of the device. In certain embodiments, such as pictured in Figure 31C, the reference may be a sphere at the end of the prong 216.

[0159] In alternative embodiments, the fiducials may be designed differently and may contain different shaped objects to help orient the device. The top of the clot removal device may contain a three-pronged imaging fiducial that is perpendicular to the tubular body.

[0160] Referring now to Figure 3 IE, a top view of the clot removal device is depicted. The auxiliary tool connection 220 may be in the retracted position 221a. All components may be contained within the tubular body 201. In some embodiments, the device 200 may have a suction port 207 on the handpiece 203. An aspiration lumen may be positioned in the tubular body 201 requiring a port 207 for connection to a vacuum source.

[0161] In some embodiments, the clot removal device 200 may include an irrigation port 206 on the handpiece 203. The irrigation port 206 may connect to an external irrigation source to provide irrigation through the tubular body 201 and out of the distal end. Irrigation may be constant or periodic during use, and / or upon activation by a user. Within the tubular body 201. there may be one or more irrigation lumens (see Figure 33A) directing solution provided at the irrigation port 206 to the distal end 210. In some embodiments, the irrigation port 206 is positioned opposite the suction port 207 on the handpiece 203.

[0162] Components on the handpiece, including the ports for different components, may be positioned in various ways. In some embodiments, the irrigation port 206 and the suction port 207 may be positioned on the same side of the handpiece. Alternatively, the ports may move depending on the position of components within the tubular body 201.

[0163] In alternative embodiments, the clot removal device may have a handle protruding from the device or from the handpiece. The physician may use the handle to better control and manipulate the device.

[0164] Figure 32A is an alternative embodiment of a clot removal device 300 from a top view. The clot removal device of Figures 32A and 32B may have any of the features of the clot removal device of Figures 31 A-31F. The clot removal device of Figures31A-31F may have any of the features of the clot removal device of Figures 32A and 32B. The clot removal device 300 may have a distal end 210 with a deflected tip 302. The deflected distal tip may allow the operator to visualize the vessel differently and improve navigation around the blood vessels within the patient. Deflection may occur laterally and / or sideways at various angles. In the embodiment in Figure 32A, the tip 302 is deflected laterally from the tubular body 201. The deflection may be at an acute angle, for example, about 20 degrees, or about 30 degrees, or more, from the tubular body 201. The angle of the deflected tip allows the tubular body 201 to be rotated, allowing the operator to visualize the vessel or clot site from different perspectives. In other embodiments, the clot removal device may include a non-deflectable tip that remains straight.

[0165] Figure 32B is an illustration of the distal end of the tip 302. In this embodiment, the imaging component 21 1 may be centrally located in the tubular body 201 with the aspiration ports 408 and multiuse lumen 404 positioned around the imaging component 211. The distal end may be tapered such that the imaging component 211 terminates at a most distal position.

[0166] As depicted in Figure 33A, the tubular body 201 of a clot removal device may contain multiple lumens. The clot removal device of Figures 33A-33C may have any of the features of the clot removal deice of Figures 31A-32B. Lumens may span from the distal end to the proximal end 224. Each lumen may have an opening or port at both the distal end and the proximal end 224 of the tubular body 201 to provide access to the interior of a patient’s body, such as the brain. The openings may allow insertion of tools. As illustrated, the distal end of the tubular body 201 may include two aspiration ports 408, a lumen for an imaging component 411, a multipurpose or multiuse lumen 404 that may accommodate a variety of other medical instruments, and two off-set irrigation jets 410. Openings at the proximal end 224 can serve as an access point or attachment site. For example, the aspiration ports 408 can include openings at the distal end for applying suction at a clot site, and the aspiration lumen can be attached to a suction source at the handpiece, for example, a vacuum or negative pressure source.

[0167] In some embodiments, as shown in Figure 33A. there may be an imaging component 211, such as a camera or endoscope, incorporated into the tubular body 201 within one of the lumens. The imaging component 211 may be fixedly attached to the tubular body 201, or may be removable (e.g., slidably removable). The lens of the imaging component 211 may be flush with the face of the distal end 210. Images taken with the imaging component 211 may be transmitted to and displayed on a display of the monitordisclosed herein, allowing a user to navigate around a clot site and / or provide indication of the size and / or shape of the clot. Positioning of the imaging component may be offset from the center of the tubular body 201. For example, the imaging component would be located on the bottom half of the distal end during use of the device 200.

[0168] In certain embodiments, the distal end may contain one or more j ets 410. The jets 410 may be located at opposite sides of the imaging component 211. As shown in Figure 33C, the irrigation jets 410 may protrude slightly from the distal end. The jets 410 may be angled so that an irrigation solution exiting the orifice of each jet 410 washes the area directly in front of the imaging component 211 and washes the lens of the imaging component. The irrigation source may also be activated to rinse the clot site for improved visibility. In certain embodiments, a first jet can be angled towards the camera, and a second jet can be angled towards the imaging component 211. The first and second jets may be directed symmetrically about the imaging component 211. A stream of irrigation solution from one or multiple jets may improve the imaging quality and area. In some such embodiments, the system may pump saline through the jets to the distal end. The jets present around the imaging component 21 1 may provide a saline stream and prevent or at least reduce the need for the operator to remove the imaging component or the clot removal device from the patient in order to clean the imaging component during the procedure. In some embodiments, multiple irrigation sources may be used for the different jets. The multiple irrigation sources may be turned on and off simultaneously or independently of one another. For example, a different pump may be connected to each jet or irrigation port for separate control. Additionally, the irrigation jets may be operated at the same pressure or different pressures. Optionally, the same jet may be operated at different pressures. For example, a first pressure may be used for breaking up the clot; a second pressure may be used for cleaning the endoscope lens by washing away the blood on the lens to improve visualization. In some embodiments, multiple irrigation jets may be actuated simultaneously. For example, multiple irrigation jets may be connected to the same pump and operate at the same time and under the same pressure.

[0169] In alternative embodiments, the jets 410 may be positioned at different angles towards or away from the camera. For example, the jets may be aimed to provide irrigation solution directly onto the lens of the camera. Alternatively, the jets may be positioned to deposit irrigation solution in the area directly in front of the lens of the camera or at varying distances in front of the lens. In some embodiments, the angle of the jets may be adjustable or changed.

[0170] In some embodiments, two aspiration ports 408 may be present at the distal end. Each aspiration port 408 is the opening to a separate aspiration lumen running the length of the tubular body 201. When a vacuum pump is attached to the proximal end 224 of the aspiration lumen, the operator can control when aspiration is applied to the clot at the distal end of the clot removal device. The aspiration ports can be connected to a waste reservoir (see Figure 30) at the proximal end 224 so that when suction is applied, any removed material is collected in a container. The negative pressure applied may range from, for example, 300 to 600 mmHg, at the distal end when vacuum is applied.

[0171] In some embodiments, there may be more or fewer than two jets around the imaging component. Alternatively, the jets may be placed at other areas on the distal end to provide irrigation to a specific site or to allow for a flushing method to be used in combination with the aspirators to clear the clot site. Each jet may be angled differently to focus the solution at a particular point in front of the distal end. Solutions other than sterile saline may be irrigated through the jets, such as another physiologically compatible fluid. Pressure of the provided solution may be regulated at the clot site to achieve approximately 0 mmHg to 3000 mmHg, although pressure conveyed by the jets may vary.

[0172] During use, the aspiration ports may be connected to an alternative source of suction such as a hospital wall supply, hand operated syringe, or a foot operated suction device. Number and dimensions of the aspiration lumens may vary, but in certain embodiments the aspiration port may have irregular shapes (not perfectly circular) to occupy the remaining space around the other lumens or devices. In some embodiments, the aspirator port has a cross-sectional area that is 33% or more, or 50% or more, or 66% or more, of the cross-sectional area of the distal end of the tubular body 201.

[0173] In certain embodiments, the multiuse lumen 404 and the imaging lumen are generally circular with generally circular openings at the distal end. Alternatively, the lumen and openings may be irregularly shaped, such as square or oval, to accommodate the shape of certain instruments. The aspiration ports may be irregularly shaped.

[0174] As depicted in Figure 33B, in some embodiments, the tubular body 201 may have a multiuse lumen 404 above, or opposite from, the imaging component 211. The multiuse lumen 404 may accommodate different medical devices and auxiliary tools 220, which to be slidably inserted at the proximal end 224 and may extend past the distal end. The medical devices inserted within the multiuse lumen 404 may be exchanged depending on the stage of the clot removal procedure. For example, an ultrasound or ultrasonic transducer may first be inserted into the multiuse lumen 404 when the doctor is imagingthe clot area. Once aspiration of the clot occurs, the multiuse lumen 404 may then be used for a cautery device to limit or stop bleeding as the clot is removed. In one embodiment, the system may accommodate both ultrasound and aspiration simultaneously. In one embodiment, the ultrasound may use the same lumen (for example, the multiuse lumen 404) as the cautery tool. When cautery7is required, the ultrasound probe can be removed and the cautery device is inserted instead. Cautery7may be used under direct visualization with the endoscope to visualize where bleeding is occurring. The endoscope may also be used to ensure that the cautery is being used to properly seal the bleeding site.

[0175] Figure 33C depicts a side view of the distal end 210 of the clot removal device showing that the face of the distal end is shaped having both an upper angled portion 412 that is sloped back towards the device and a flat portion. A split shape at the distal end 210 may allow for the camera to be fully contained and protected within the tubular body 201 of the clot removal device while simultaneously creating an atraumatic tip for safer and easier navigation of the distal end within the patient. The top half of the distal end 412 may be angled at 45 degrees. The jets can be slightly protruding from the end of the device to enable them to irrigation solution back on the lens at a fixed angle.

[0176] Referring now to Figure 34A, the distal end may have various shapes to prevent trauma to the patient. For example, the distal end may be round and tapered to resemble a cone shape. The imaging component may be removably inserted through the proximal end 224 of the tubular body 201. The imaging component may span the length of the tubular body 201 to image the clot site from an opening at the distal end when the tubular body 201 is inserted into the patient’s body. The operator or doctor may be able to slide the camera into and out of the lumen and openings to reposition the field of view or for cleaning the lens. The camera may be pushed into the lumen so that the lens protrudes from the distal end. Additionally, in some embodiments, the multiuse lumen 404 may allow devices to be inserted to protrude past the distal end. For example, an ultrasound may be inserted into the multiuse lumen 404 and may extend past the distal end to better image the vessel, instead of having to insert the entire distal end of the tubular body 201. The auxiliary tool 220 may also be slidably inserted into the multiuse lumen 404.

[0177] Figure 34B is a close view of the distal end of an alternative embodiment of the clot removal device. The distal end may have several lumens with openings present at the distal face such as two aspiration ports and a multiuse lumen 404 positioned directly above an imaging component. As depicted, the irrigation jets may be two irrigation ports to provide solution at the distal tip instead of angled ports.

[0178] In alternative embodiments, the distal end may be flat or have an offset center that comes to a point. In yet another embodiment, the distal end may be sloped or angled 412 across the entire face so that there is no flat portion.

[0179] Figure 34C illustrates the clot removal device from Figure 34B with all internal components removed and the openings at the distal end to each of the lumens in the tubular body 201.

[0180] Referring now to Figure 35A, a perspective view of an alternative embodiment of clot removal device is illustrated. Similar to Figure 33 A, the internal lumens can have openings at the distal end 210. A multiuse lumen 404 may be positioned on the upper half of the tubular body 201. A lumen accommodating an imaging component may be positioned below and opposite from the multiuse lumen 404. The imaging component 211 may be fixed within the tubular body 201. Figure 35 A illustrates two irrigation lumens or irrigation jets. The first irrigation jet may be angled toward the lens of the imaging component, this may be a scope rinse nozzle 212. The second irrigation jet may not be pointed at an angle, and instead may project solution directly in front of the distal end 210. The second irrigation jet may be used as a clot disruption nozzle 213. Two aspiration ports 214 may be positioned around the lumens on either side of the tubular body 201. Similar to the embodiment in Figure 33A, the distal end 210 may have a flat portion. The distal end 210 may also have an angled portion where the multiuse lumen 404 is positioned. Within the multiuse lumen 404 may be an ultrasound in a retracted position 230a.

[0181] Figure 35B is a perspective view of the distal end 210 of an embodiment of the tubular body 201 with an ultrasound probe extended 230b or protruding from the multiuse lumen 404.

[0182] Figure 35C is a perspective view of the distal end 210 of the tubular body 201 with a cautery device 240 (e.g., a bipolar cautery device) within the multiuse lumen 404. As previously described, different instruments may be inserted into the multiuse lumen 404 during a procedure, such as an ultrasound transducer or a cautery instrument. The device may be positioned by manipulation of the handpiece of the clot removal device.

[0183] Figure 35D is a perspective view of the distal end 210 of the tubular body 201 with an ultrasound extending 250 from the face. Using an ultrasound device within the multiuse lumen 404 provides an additional tool to help break up the clot prior to aspiration by providing better visualization of the clot site when there is bleeding, which can make it difficult for a user to see the clot with a view provided by the scope.

[0184] Figure 35E is a front view of the distal end 210 of the clot removal device as illustrated in Figure 35A. Openings to several lumens may be visualized from this angle. A multiuse lumen 404 may be positioned at the top portion of the distal end 210. An imaging component may be positioned directly below the multiuse lumen 404. The distal end 210 of the auxiliary7tool 222 may be seen within the multiuse lumen 404.

[0185] Figure 35F is a perspective view of a clot removal device having any of the features of the clot removal device as pictured in Figure 35A. However, as shown in Figure 35F, the tubular body 201 may have an ultrasound on the external surface 208 for visualization at the distal end 210.As shown, an ultrasound probe may have forward looking ultrasound arrays. Alternatively, the ultrasound probe may have forward looking ultrasound arrays and can be extended to reveal an array ring allowing for a radial looking ultrasound view. As another alternative embodiment with a cannula, the array ring for radial looking ultrasound may be located on the cannula.

[0186] Figure 36A is a perspective view of another embodiment of the tubular body 201 of the clot removal device. The clot removal device of Figure 36A may have any of the features of the clot removal device of Figures 31A-35A. The clot removal device of Figures 31A-35A may have any of the features of the clot removal device of Figure 36A. The face of the distal end 210 may be cone shaped and come to a flat point in the center around the opening of the multiuse lumen 404. The clot removal device as shown in Figure 35A can include a series of openings providing access to internal lumens and may be positioned in various manners. For example, the multiuse lumen 404 may be positioned in the center of the tubular body 201. An ultrasound 230b may be extended through the lumen for visualization of the clot site. The other lumens positioned around the center may not have round openings due to the pointed shape of the distal end 210. Instead, openings may be oval in shape. Alternatively, the openings may take on a number of different shapes and the openings may not be round.

[0187] When the multiuse lumen 404 is centrally positioned, the imaging component 211 may be located above. The distal end 210 may have an irrigation jet or clot disruption nozzle 213 positioned around the multiuse lumen 404.

[0188] Figure 36B illustrates yet another perspective view of the distal end 210 where the multiuse lumen 404 may be positioned centrally, with the imaging component 211 positioned above. As pictured, the multiuse lumen 404 may have an ultrasoundpositioned within, in a retracted state 230a so that tool is entirely within the tubular body 201.

[0189] Figure 37A is an alternative embodiment of the distal tip of the clot removal device. Alternative to Figure 36A, the imaging component 211 may be centrally positioned within the tubular body 201. A cautery device 240 may be within the multiuse lumen 404 and extended past the distal end 210. As previously described, any device in the multiuse lumen 404 may be prohibited from extending a certain amount, such as 5mm, to prevent unintentional injury to the patient if the device is extended too far into the clot site. In certain embodiments, the imaging component may be fixed within the center and may be unable to be extended past the distal end 210.

[0190] Figure 37B illustrates an ultrasound transducer within the multiuse lumen 404 in place of the cautery tool. The ultrasound is depicted in an extended position 250 from the distal end 210.

[0191] Figure 37C shows the front view of the distal end 210 of the clot removal device of Figure 37A. The multiuse lumen 404 may be positioned at the top of the tubular body 201 with the imaging component 211 fixed in the center. The distal tip of an auxiliary tool 222 may be visualized from the front view. Three aspiration ports 214 surround the imaging component 211. In some embodiments, a vacuum source may be connected to the aspiration ports at the proximal end 224 of the tubular body 201. Two irrigation jets can be positioned between the aspiration ports. One irrigation jet may be a scope rinse nozzle 212 and the other may be a clot disruption nozzle 213.

[0192] However, alternative embodiments of the distal end 210 from Figures 37A-37C may include different variations of nozzles or jet ports. The jets may be both positioned inwards toward the imaging component. There may be only one or more than two irrigation jets, each angled differently at the distal end 210.

[0193] Figure 38A illustrates a perspective view of the distal end 210 of another embodiment of the clot removal device. The imaging component may be located in the center with the multiuse lumen 404 positioned around the imaging component. As shown in Figure 38A. the distal end 210 of the clot removal device may come to a circular point with the openings chamfered down the sides of the tubular body 201. As the openings stretch back along the length of the tubular body 201, the openings increase in size from the distal end 210 to the proximal end 224. One benefit may include a larger aspiration port for increased suction within the clot site. The imaging component may be positioned in the center of the tubular body 201 so that the images are taken at or near the center of the vesselwithin the clot site. The multiuse lumen 404 may be disposed around the outside of the tubular body 201 between two aspiration ports. The user may manipulate or twist the tubular body 201 within the clot site so that the multiuse lumen 404 is positioned in different positions around the camera.

[0194] Figure 38B is a side view of the distal end 210 of the clot removal device from Figure 38A. The tip may be deflected at a certain angle from the tubular body 201 as disclosed herein.

[0195] Figure 39 is a perspective view of a control console as part of the clot removal system. The control console 300 may control one or more of the devices within the system. The control console may have control boxes or various components that may be changed depending on the type of procedure occurring. For example, the control console may have a monitor 303 to track statuses and measurements of the devices and / or to display images. A keyboard 304 may be connected to the monitor for data entry or selection of different control options. The console 300 may have a wheeled cart 301 with shelves to hold each device. The wheeled cart may facilitate mobility of the system. Within the console 300 a holder for the suction canister 305 may ensure the suction canister stays upright during use. An aspiration control box 307, an ultrasound control box 308, an irrigation control box 309, and an auxiliary tool control box 310 may be positioned on the console 300. The aspiration control box 307 can allow a user to activate or deactivate the suction source or adjust the settings of the section source. The ultrasound control box 308 can allow a user to activate or deactivate the ultrasound probe or adjust settings of the ultrasound probe. The auxiliary7tool control box 310 may allow a user to control other medical devices inserted via the multiuse lumen 404, for example, for controlling a cautery device. One or more processors may be used to control the components in the control console. Each of the components of the system may have their own processor or there may be fewer processors.

[0196] Figure 40 illustrates a hub as part of the clot removal system. A hub 700, as depicted, enables the operator to attach the handpiece portion of the removal device to other components of the system for all components to operate as an integrated assembly. For example, the removal device with the tubular body containing the multiuse lumen 404, irrigation jets, imaging components, and aspiration can connect to the central hub on a first side. On the opposite side of the hub, on a second side, there are connections for the camera, the display, the ultrasound, or power for the cautery device. The hub may act as a central connection for all the components in the handpiece of the clot removal device, permittingeasier manipulation and movement of the device as well as power to the individual components.

[0197] In alternative embodiments, there may be more than one hub in the system. Multiple hubs may connect to each other or have a configuration that is specific to the clot removal system used for a particular surgical procedure. In certain embodiments, each hub may contain ports for various devices.

[0198] Certain ranges are presented herein with numerical values being preceded by the terms “about,” “around,” and “approximately.” These terms are used herein to provide literal support for the exact number that it precedes, as well as a number that is near to or approximately the number that the term precedes. In determining whether a number is near to or approximately a specifically recited number, the near or approximating unrecited number may be a number which, in the context in which it is presented, provides the substantial equivalent of the specifically recited number.

[0199] It is noted that, as used herein and in the claims, the singular forms “a”, “an”, and “the” include plural referents unless the context clearly dictates otherwise. It is further noted that the claims may be drafted to exclude any optional element. As such, this statement is intended to serve as antecedent basis for use of such exclusive terminology as “solely,” “only” and the like in connection with the recitation of claim elements, or use of a “negative” limitation.

[0200] As will be apparent to those of skill in the art upon reading this disclosure, each of the individual embodiments described and illustrated herein has discrete components and features which may be readily separated from or combined with the features of any of the other several embodiments without departing from the scope or spirit of the present invention. Any recited method can be carried out in the order of events recited or in any other order which is logically possible.

[0201] Features, materials, characteristics, or groups described in conjunction with a particular aspect, embodiment, or example are to be understood to be applicable to any other aspect, embodiment or example described in this section or elsewhere in this specification unless incompatible therewith. All of the features disclosed in this specification (including any accompanying claims, abstract and drawings), and / or all of the steps of any method or process so disclosed, may be combined in any combination, except combinations where at least some of such features and / or steps are mutually exclusive. The protection is not restricted to the details of any foregoing embodiments. The protection extends to any novel one, or any novel combination, of the features disclosed in thisspecification (including any accompanying claims, abstract and drawings), or to any novel one, or any novel combination, of the steps of any method or process so disclosed.

[0202] While certain embodiments have been described, these embodiments have been presented by way of example only and are not intended to limit the scope of protection. Indeed, the novel methods and systems described in this section or elsewhere in this specification may be embodied in a variety of other forms. Furthermore, various omissions, substitutions and changes in the form of the methods and systems described in this section or elsewhere in this specification may be made. Those skilled in the art will appreciate that in some embodiments, the actual steps taken in the processes illustrated and / or disclosed may differ from those shown in the figures. Depending on the embodiment, certain of the steps described above may be removed, others may be added. Furthermore, the features and attributes of the specific embodiments disclosed above may be combined in different ways to form additional embodiments, all of which fall within the scope of the present disclosure.

[0203] Although the present disclosure includes certain embodiments, examples and applications, it will be understood by those skilled in the art that the present disclosure extends beyond the specifically disclosed embodiments to other alternative embodiments and / or uses and obvious modifications and equivalents thereof, including embodiments which do not provide all of the features and advantages set forth in this section or elsewhere in this specification. Accordingly, the scope of the present disclosure is not intended to be limited by the specific disclosures of preferred embodiments in this section or elsewhere in this specification, and may be defined by claims as presented in this section or elsewhere in this specification or as presented in the future.

Claims

WHAT IS CLAIMED IS:

1. An intracranial device for removing blood or tissue from a patient, comprising: a tubular body having a proximal end and a distal end, the distal end comprising a flat surface and an angled surface; a first lumen extending from the proximal end to the distal end of the tubular body, a proximal end of the first lumen configured to be coupled to a negative pressure source; a second lumen extending from the proximal end to the distal end of the tubular body, a distal end of the second lumen terminating at least partially at the angled surface, the second lumen configured to slidably receive one or more additional instruments, the one or more additional instruments comprising one or more of an ultrasound probe and a hemostasis tool; a third lumen extending from the proximal end to the distal end of the tubular body, a distal end of the third lumen terminating at least partially at the flat surface, the third lumen configured to accommodate an imaging component; and a fourth lumen and a fifth lumen each extending from the proximal end to the distal end of the tubular body, proximal ends of the fourth lumen and the fifth lumen configured to be coupled to one or more irrigation sources, the fourth lumen defining a first irrigation path and the fifth lumen defining a second irrigation path, the fourth and fifth lumens located on opposite sides of the third lumen and distal ends of the first and second irrigation paths positioned at an angle to a longitudinal axis of the tubular body such that, when in use, irrigation jets exiting the first and second irrigation paths cross each other at a location directly in front of the distal end of the third lumen.

2. The device of claim 1, further comprising a control system configured to control the negative pressure source, the imaging component, the irrigation source, and the one or more of the ultrasound probe and the hemostasis tool.

3. The device of claim 1. further comprising a first processor configured to control the negative pressure source, a second processor configured to control the ultrasound probe, a third processor configured to control the imaging component, a fourth processor configured to control the hemostasis tool, and a fifth processor configured to control the irrigation source.

4. The device of claim 1, wherein the irrigation source includes a saline pump.

5. The device of claim 1, wherein the negative pressure source includes a vacuum pump.

6. The device of claim 1, wherein the hemostasis tool is a cautery tool.

7. An intracranial device for removing blood or tissue from a patient, comprising: a tubular body comprising a proximal end configured to be positioned outside of the patient and a distal end configured to be advanced through a skull of the patient; a plurality of aspiration lumens extending from the proximal end to the distal end of the tubular body; a multipurpose lumen extending from the proximal end to the distal end of the tubular body configured to removably receive one or more auxiliary tools; an imaging component at the distal end of the tubular body; and a plurality of irrigation ports at the distal end of the tubular body.

8. The device of claim 7, wherein the aspiration lumens comprise an angled or tapered opening at distal ends thereof.

9. The device of claim 8, wherein the imaging component is positioned distal to the angled or tapered opening of the aspiration lumens.

10. The device of claim 7, wherein the distal end of the tubular body comprises a flat surface and an angled surface.1 1. The device of claim 10, wherein the imaging component and the irrigation ports are positioned at the flat surface and distal ends of the aspiration ports and a distal end of the multipurpose lumen is positioned at the angled surface.

12. The device of claim 7, wherein the distal end of the tubular body comprises a tapered distal tip.

13. The device of claim 12, wherein the imaging component is positioned at a distal end of the tapered distal tip and distal ends of the aspiration lumens, a distal end of the multipurpose lumen and the irrigation ports are positioned along tapered surfaces of the tapered distal tip.

14. The device of claim 12, wherein the multipurpose lumen extends centrally through the tapered distal tip and the imaging component, distal ends of the aspiration lumens, and the irrigation ports are positioned along tapered surfaces of the tapered distal tip.

15. The device of claim 7, further comprising one or more auxiliary tools advanceable through the multipurpose lumen and beyond the distal end of the tubular body.

16. The device of claim 15, wherein the auxiliary tool comprises an ultrasound device.

17. The device of claim 15, wherein the auxiliary tool comprises a cautery device.

18. The device of claim 7, wherein one of the irrigation ports is configured to rinse the imaging component.

19. The device of claim 7, wherein one of the irrigation ports is configured to disrupt a clot.

20. The device of claim 7, further comprising a handpiece at the proximal end of the tubular body.

21. The device of claim 20, further comprising fiducial markers on the handpiece.

22. The device of claim 7, further comprising a control system configured to: control negative pressure applied through the aspiration lumens; deliver irrigation through the irrigation ports; and control operation of the one or more auxiliary tools.

23. The device of claim 7, further comprising a display to display an image taken from the imaging component.

24. The device of claim 23, further comprising a second display to display an ultrasound image taken from an ultrasound device advanced through the multipurpose lumen.

25. A method of removing blood or tissue in or around a brain of a patent, the method comprising: delivering an aspiration device through a skull of a patient, the aspiration device comprising an imaging component at a distal end of the aspiration device, one or more aspiration lumens, and a multipurpose lumen; directing the aspiration device to a target site in the patient while displaying an image taken by the imaging component; and with an ultrasound device extending through the multipurpose lumen, aspirating blood or tissue from the target site through the one or more aspiration lumens while displaying at least an ultrasonic image taken by the ultrasound device.

26. The method of claim 25, further comprising removing the ultrasound device from the multipurpose lumen, introducing a cautery device into the multipurpose lumen, and operating the cautery device to cauterize tissue.

27. The method of claim 25, wherein aspirating blood or tissue through the one or more aspiration lumens comprises aspirating a blood clot.

28. The method of claim 25, wherein the image taken by the imaging component and the ultrasonic image are displayed on one or more displays.

29. The method of claim 25, wherein the one or more aspiration lumens provide suction at the distal end of the aspiration device by a negative pressure source connected to a proximal end of the aspiration device.

30. The method of claim 25, further comprising tracking positioning of the aspiration device with a neuronavigation system, wherein fiducial markers are positioned on a handpiece of the aspiration device.

31. An intracranial device for removing blood or tissue from a patient comprising: a tubular body having a proximal end and a distal end. the distal end comprising a flat surface and an angled surface; and a plurality of lumens extending from the proximal end to the distal end of the tubular body, at least one of the plurality of lumens terminating at the flat surface and at least one of the plurality of lumens terminating at the angled surface.

32. An intracranial device for removing blood or tissue from a patient comprising one or more features of the foregoing description.

33. A method of removing blood or tissue in or around a brain of a patient comprising one or more features of the foregoing description.

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