WO2025171045A1 - Surgical removal of hemorrhaged blood from inside a patient's body - Google Patents

Abstract

Provided are methods of removing hemorrhagic blood from a body region of a patient, such as from the brain. The methods can include recording X-ray images of the body region and the blood, thereby allowing for the selection of a desired trajectory from the surface of the body to the blood. A sheath is inserted into the body along this desired trajectory. The sheath can have X-ray visible fluoroscopic markers that help ensure correct three-dimensional orientation of the sheath during insertion. Afterwards, the hemorrhaged blood can be removed through the open, internal lumen of the sheath. Also provided are blood removal devices that can be inserted into the sheath, thereby helping to remove the blood from the patient. Such devices can have a cutting element that cuts the solidified blood, thereby aiding in its removal from the patient.

Description

SURGICAL REMOVAL OF HEMORRHAGED BLOOD

FROM INSIDE A PATIENT’S BODY

CROSS-REFERENCE

[0001] This application claims the benefit of U.S. Provisional Application No. 63/551,446, filed on February 8, 2024, which is incorporated herein by reference in its entirety.

INTRODUCTION

[0002] Intracerebral hemorrhage (ICH) is a bleeding that occurs from a broken blood vessel within the brain and is the deadliest, costliest and most debilitating form of stroke. ICH accounts for -20% of all strokes in the Western world and for >30% in low- and middle-income countries, with an increasing incidence given the aging population and the use of anticoagulation therapy (1,2). Despite extensive medical and surgical attempts to limit the damage from ICH, this condition continues to be the most devastating type of stroke with a 30-day mortality around 40%. The available surgical options to remove clots require large skull openings and brain disruption, or are based on minimally invasive technology that depends on sophisticated “navigation guidance” which delays the evacuation of clots. In addition, clot evacuation currently requires multiple systems to visualize the procedure (like surgical microscope, exoscope or endoscopes), specialized electrosurgical bipolar for hemostasis, and a craniotomy (window in the skull). The set up of these systems is time consuming, which further delays initiation of surgery.

[0003] Reference 1 : Krishnamurthi et al, Neuroepidemiology, 2020, doi: 10.1159/000506396 [0004] Reference 2: GBD 2019 Stroke Collaborators, “Global, regional, and national burden of stroke ... of Disease Study 2019”, The Lancet Neurology, doi:10.1016/S1474-4422(21)00252-0

SUMMARY

[0005] Provided are methods of removing hemorrhagic blood from a body region of a patient, such as from the brain. The methods can include recording X-ray images of the body region and the blood, thereby allowing for the selection of a desired trajectory from the surface of the body to the blood. A sheath is inserted into the body along this desired trajectory. The sheath can have X-ray visible fluoroscopic markers that help ensure correct three-dimensional orientation of the sheath during insertion. Afterwards, the hemorrhaged blood can be removed through the open, internal lumen of the sheath. Also provided are blood removal devices that can be inserted into the sheath, thereby helping to remove the blood from the patient. Such devices can have a cutting element that cuts the solidified blood, thereby aiding in its removal from the patient.

BRIEF DESCRIPTION OF THE DRAWINGS

[0006] FIG. 1 shows CT and schematic images of a hemorrhage in the brain of a patient.

[0007] FIG. 2 shows three orthogonal views (axial, coronal, and sagittal) of a human brain with a trajectory (dotted lines) from a superficial entry site to a deep target site in a hemorrhage. Skin and skull are not represented for simplification purposes.

[0008] FIG. 3 shows two different X-ray imagers aligned in the x-y or z planes.

[0009] FIG. 4 shows x-y-z axes, trajectory alignment using the central beam of a X-ray instrument, and the types of movements that can be detected with fluoroscopy or optically.

[0010] FIG. 5 shows Fluoroscopic View A in the x-y plane and Fluoroscopic View B in the z plane.

[0011] FIG. 6 shows at the top a representation of a first x-ray imager with its central beam aligned to the intracerebral hemorrhage of a patient and a tubular device with two fluoroscopic markers. The image of the right represents the fluoroscopic bull eye view with alignment of the two fluoroscopic markers and the intracranial hemorrhage along the central beam in the x-y plane. The bottom panel of FIG. 6 shows a second x-ray imager substantially perpendicular to the first x-ray imager providing a fluoroscopic view substantially perpendicular to the plane bisecting the target and entry point.

[0012] FIG. 7 shows options for fluoroscopic markers and how they would appear in either the x-y plane or in the z image.

[0013] FIG. 8 shows a sheath with a tubular body and a handle.

[0014] FIG. 9A shows a trocar with fluoroscopic markers.

[0015] FIG. 9B shows a navigation stylet (or probe) channel.

[0016] FIG. 9C shows a navigation stylet with orientation elements.

[0017] FIG. 10 shows a surgical device with suction element, camera (i.e. scope), light, irrigation channel, irrigation trigger, suction trigger, clot cutting trigger, video display, SD card, handle, radiofrequency (RF) cord, vacuum and suction elements, and irrigation supply element.

[0018] FIG. 11 shows a cross-section of the barrel of the FIG. 10 device.

[0019] FIG. 12 shows a system including the FIG. 10 device and auxiliary devices.

[0020] FIG. 13 shows a sheath and the insertion of the FIG. 10 device into the sheath.

[0021] FIG. 14A shows the end of the barrel with integrated, protruding, and side-wall electrodes. [0022] FIG. 14B shows electrodes and field lines from the electrodes, along with the cutting and suction of the clot.

[0023] FIG. 15 A shows bipolar dura(coag), i.e. coagulation of the dura with bipolar electrodes. [0024] FIG. 15B shows bipolar cortex coagulation.

[0025] FIG. 15C shows RF thrombolysis (cut), i.e. thrombus fragmentation by radiofrequency.

[0026] FIG. 15D shows bipolar bleeding vessel coagulation and suction.

[0027] FIG. 16A shows loop wire hinge for clot cutting and ingestion.

[0028] FIG. 16B shows mechanical clot cutters at the distal barrel opening actuated by relative longitudinal movements of the parts.

[0029] FIG. 17 shows a mechanical clot cutter with longitudinally displaceable tongue that arcs toward the barrel lumen.

[0030] FIG. 18A shows a brush shaped device and a spinning shape device.

[0031] FIG. 18B shows a shaped spinning device and an Archimedes screw type device.

[0032] FIG. 18C shows a spinning mechanism for clot removal.

[0033] FIG. 19A shows hydrojet clot cutter mechanism.

[0034] FIG. 19B shows a mechanism with hydrojet clot cutting, radiofrequency electrosurgery and suction lumen.

[0035] FIG. 20 shows embodiments that use additional features to enhance clot ingestion and clot fragmentation RF features.

[0036] FIG. 21 shows embodiments that combine clot cutting and electrocoagulation. Push wire is advanced exposing a loop wire with an electrode at the apex of the loop to the front end of the lumen and approximating to another electrode at the apex of the bevel of the aspirating cannula [0037] FIG. 22 shows vacuum removes blood and pulls the bleeding arterial branch into the cannula, followed by electrocoagulation of the bleeding branch by approximation of electrodes and delivery of current.

[0038] FIG. 23 shows vacuum pulling into the tube the bleeding artery, followed by arterial compression between the advancing tongue and static electrode for bipolar coagulation and hemostasis.

[0039] FIG. 24A shows a method to evacuate an intracerebral hematoma with frameless fluoroscopic stereotactic navigation and the clot MINE device. The figure shows (1) trajectory alignment of central x-ray beam with entry and target points with fluoroscopic flat panel visualization, and (2) skin incision, burrhole creation in skull, dura coagulation with clot MINE bipolar electrode.

[0040] FIG. 24B shows (3) dura opening and coagulation and (4) advancement of sheath and trocar into brain with X-ray guidance. [0041] FIG. 24C shows (5) removal of trocar from sheath and introduction of clot MINE into sheath and (6) ingestion of clot. In typical situations, the clot enters the sheath and this is ingested by the clot MINE device. The clot MINE device can be advanced into the clot and beyond the sheath as needed.

[0042] FIG. 24D shows (7) cavity inspection with scope and irrigation and (8) coagulation of the bleeding vessel.

[0043] FIG. 25 shows another embodiment of the device formed by a tubular structure entering the brain. FIG. 25A shows a device with handle, seal, RF cord, suction cord, irrigation, sheath, a RF ring electrode built in the sheath wall, and a lumen. In this embodiment, the vacuum is provided by the suction cord to the sheath, resulting in clot ingestion directly into the sheath.

[0044] FIG. 25 B shows a clot MINE device with a scope and light and an RF electrode mounted over a movable tongue.

[0045] FIG. 25C shows motion of tongue based on pulling the trigger of the FIG. 25B device. [0046] FIG. 26 shows the clot MINE device inside the sheath, and the sheath inserted inside the brain and into a clot. Vacuum is applied to the sheath resulting in clot ingestion and inward displacement of a bleeding artery. Actuation of the trigger result in movement of the tongue into the lumen and towards the ring electrode, facilitating bipolar electrocoagulation.

[0047] FIG. 27A shows a guider device with a guider body, guider handle, and fluoroscopic markers.

[0048] FIG. 27B shows the FIG. 27 A guider device along with a drill for drilling through the bone, the body of the patient, and how the Anorogenic markers appear on the x-y plane imager. The 3D orientation of the guider was provided aligning the Auoromarkers along a central x-ray beam bisecting the pre-selected entry and target points.

[0049] FIG. 28 shows devices with bone spikes that are either fixed or adjustable. By pressing against the bone, the bone spikes can prevent the sheath from slipping, rolling and pitching. Adjustable spikes can be advanced or retracted from the guider to provide and maintain the required angulation to the skull surface.

[0050] FIG. 29A shows a first step where the fluoroscopic markers of the Xray guider are aligned with the central ray of the Auoroscopic unit. The height of each spike is adjusted to rest and fix the Xray guider to the surface of the skull to maintain the trajectory.

[0051] FIG. 29B shows a second step where the Xray guider is pushed against the skull surface with its lumen providing the trajectory into the target. Then, a drill can be advanced to perforate the bone, or a catheter can be placed aiming the ventricle or another intracranial target.

[0052] FIG. 30A shows an X-ray guider with adjustable spider arms that can stabilize in 3 dimensions. [0053] FIG. 30B shows a spider-arm device that is attached at the entry point, thereby helping to guide a drill towards the target site.

[0054] FIG. 31A shows the components of an assembly for frameless fluoroscopic stereotaxis including a base, a guider and a locker.

[0055] FIG. 3 IB shows an assembled frameless fluoroscopic stereotaxis system with a receiving socket attached to bone with screws.

[0056] FIG. 32A shows first two steps using a the frameless fluoroscopic stereotaxis system of FIG. 3 IB. Left panel shows the central x-ray of a fluoroscopic unit aligned to cross a superficial entry point and a deep intracranial target point. The right panel shows skin incision and anchoring to the skull of the frameless fluoroscopic stereotaxis system along the central x-ray trajectory.

[0057] FIG. 32B shows a third step of the procedure with fluoroscopic-based alignment of the guider of the frameless fluoroscopic stereotaxis system and related fluoromarkers with a central x-ray beam crossing an entry and a target point. The trajectory of the guider is maintained stable by the locker mechanism.

[0058] FIG. 32C shows a fourth and fifth step of the procedure using the frameless fluoroscopic stereotaxis system. The left panel shows the creation of a burr hole in the skull with a drill operating through the guider of the frameless fluoroscopic stereotaxis system previously fixed in the trajectory of the entry and target points. The right panel shows the advancement of a tubular element though the guider following the pre-set trajectory to the target point.

[0059] FIG. 33 shows a frameless fluoroscopic stereotaxis system with fluoroscopic markers designed for 3D cartesian targeting.

[0060] FIG. 34 shows embodiments of laser alignment elements for frameless stereotaxis.

[0061] FIG. 35 shows additional embodiments for laser alignment elements.

[0062] FIG. 36 shows how laser light contacts different laser alignment elements.

[0063] FIG. 37 shows additional embodiments of how laser light contacts different laser alignment elements.

[0064] FIG. 38 shows a tubular elements with a combination of peripheral and centric fluoroscopic markers and laser orientation lines at the top and on the sides for frameless stereotaxis guided by fluoroscopy and crossing lasers.

[0065] FIG. 39 shows an embodiment of a light pipe that causes light to travel down to the light pipe due to total internal reflection.

[0066] FIG. 40 shows contour lines of velocity for fluid flow around the distal end of the barrel of a blood removal device.

[0067] FIG. 41 shows pressure lines for fluid flow around the distal end of the barrel of a blood removal device. [0068] FIG. 42 shows velocity vectors for fluid flow around the distal end of the barrel of a blood removal device.

[0069] FIG. 43A shows two views of the distal end of a trocar.

[0070] FIG. 43B shows wire frame views of FIG. 43A.

[0071] FIG. 44A shows a trocar with beveled distal end 4401, proximal end 4402, laser alignment element 4403 located at proximal end 4402, and handle 4404.

[0072] FIG. 44B shows an alternate view of the FIG. 44A trocar.

[0073] FIG. 44C shows crossing orientation grooves of the laser alignment element when viewed from the opposite direction as FIG. 44B.

[0074] FIG. 45A shows a tubular member with a ball joint that can function as a piece of the drill guide.

[0075] FIG. 45B shows that fiducial markers 4501 and 4502 can be located near opposite ends of the drill guide.

[0076] FIG. 45C shows the drill guide positioned within a base, thereby permitting the ball joint to rotate within the base, e.g. by at least 60°.

[0077] FIG. 45D shows a top view of the drill base.

[0078] FIG. 45E shows a clean horizontal view and an annotated horizontal view of the base.

[0079] FIG. 45F shows different views of a twist knob for securing the tubular member to the base.

[0080] FIG. 46A shows in the first panel a wire frame drawing of a blood removal device and int the second panel a horizontal axis and vertical axis defining the blood removal device.

[0081] FIG. 46B shows a cross section of barrel 4601 of FIG. 46A near the distal end.

[0082] FIG. 46C shows an enlarged view of distal tip 4602 that contains flat surface 4620, cautery tip attachment location 4621, and bevel 4622.

[0083] FIG. 46D shows the distal end with cautery tip 4624 attached.

[0084] FIG. 46E shows a bottom view of the FIG. 46A device.

[0085] FIG. 47A shows internal components of a device.

[0086] FIG. 47B shows the device when the trigger is depressed to a first activation position.

[0087] FIG. 47C shows the trigger in its home position.

[0088] FIG. 47D shows the trigger upon depression by 15°.

[0089] FIG. 47E shows a top portion of the device in the home position.

[0090] FIG. 47F shows a top portion of the device in the second activation position.

[0091] FIG. 47G shows an enlarged view of the irrigation mechanism. Also present is housing 4716 and retainer plate 4717.

[0092] FIG. 47H shows an angled view of the section shown in FIG. 47G. [0093] FIG. 471 shows a partially transparent region of the irrigation mechanism including hook in a slot to act as a latch 4718.

[0094] FIG. 48A shows an embodiment of a distal end of the device including barrel 4801, tongue 4802, and location 4803.

[0095] FIG. 48B shows a distal section of tongue 4802.

[0096] FIG. 48C shows a tongue formed in an arcuate shape.

[0097] FIG. 49 shows a perspective view and a side view of a distal end with cautery tip 4901. [0098] FIG. 50 shows an alternative view of a distal end of the barrel with three objects inside lumen 5002.

[0099] FIG. 51 shows a view of a distal end with three objects inside lumen 5102, wherein the lumen has an approximately trapezoidal shape.

[00100] FIG. 52 shows a cutting element with neck 5203, wide section 5204, and main section 5205.

[00101] FIG 53 A shows the distal end of the barrel in resting position.

[00102] FIG. 53B shows the distal end in actuated position. [00103] FIG. 53C shows a side view of the barrel.

DETAILED DESCRIPTION

[00104] Provided are methods of removing hemorrhagic blood from a body region of a patient, such as from the brain. The methods can include recording X-ray images of the body region and the blood, thereby allowing for the selection of a desired trajectory from the surface of the body to the blood. A sheath is inserted into the body along this desired trajectory. The sheath can have X-ray visible fluoroscopic markers that help ensure correct three-dimensional orientation of the sheath during insertion. Afterwards, the hemorrhaged blood can be removed through the open, internal lumen of the sheath. Also provided are blood removal devices that can be inserted into the sheath, thereby helping to remove the blood from the patient. Such devices can have a cutting element that cuts the solidified blood, thereby aiding in its removal from the patient.

[00105] Before the present invention is described in greater detail, it is to be understood that this invention is not limited to particular embodiments described, as such may vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting, since the scope of the present invention will be limited only by the appended claims. [00106] Where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit unless the context clearly dictates otherwise, between the upper and lower limits of that range is also specifically disclosed. Each smaller range between any stated value or intervening value in a stated range and any other stated or intervening value in that stated range is encompassed within the invention. The upper and lower limits of these smaller ranges may independently be included or excluded in the range, and each range where either, neither or both limits are included in the smaller ranges is also encompassed within the invention, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the invention.

[00107] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, some potential and exemplary methods and materials may now be described. Any and all publications mentioned herein are incorporated herein by reference to disclose and describe the methods and/or materials in connection with which the publications are cited. It is understood that the present disclosure supersedes any disclosure of an incorporated publication to the extent there is a contradiction.

[00108] It must be noted that as used herein and in the appended 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 element, e.g., 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 the use of a “negative” limitation.

[00109] The publications discussed herein are provided solely for their disclosure prior to the filing date of the present application. Further, the dates of publication provided may be different from the actual publication dates which may need to be independently confirmed. To the extent the definition or usage of any term herein conflicts with a definition or usage of a term in an application or reference incorporated by reference herein, the instant application shall control. [00110] 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. SHEATH

[00111] Provided by the present disclosure are sheaths for determination of three-dimensional spatial orientation and removal of hemorrhagic blood from a body region of a patient. Provided is a sheath comprising a tubular member comprising: a proximal end comprising and a proximal opening; a distal end comprising and a distal opening; a spatial alignment element; a longitudinal axis extending from the proximal opening to the distal opening; a middle wall extending from the proximal opening to the distal opening; and a lumen defined by the proximal opening, the middle wall, and the distal opening.

[00112] In some cases, the sheath includes both the tubular member and a handle attached to the tubular member. For clarity, it is noted that the proximal end, distal end, and middle wall are all parts of the tubular member, wherein the tubular member is a part of the sheath.

[00113] For instance, the handle can be attached to the middle wall or the proximal end of the tubular member. For example, FIG. 8 shows an embodiment with such a handle. The handle can be grasped by the hand of an operator, allowing the operator to move and maintain the three- dimensional orientation of the sheath.

[00114] The lumen of the tubular member is located along the longitudinal axis from the proximal end to the distal end of the sheath. The longitudinal axis is not a physical object. Instead, the longitudinal axis is simply an imaginary line through space that helps describe the orientation of the sheath. Additionally, there are transverse axes that are perpendicular to the longitudinal axis.

[00115] For example, the tubular member can have a cylindrical shape with openings at each end, thereby providing the proximal end and the distal end. As such, the tubular member can have a circular cross-section. However, the tubular member can also have other types of cross-sections, such as square or rectangular cross-sections. For example, the tubular member can have the shape of a three-dimensional rectangle, with the proximal and distal ends located at opposite faces of the three-dimensional rectangle. In some cases, the length of the tubular member along its longitudinal axis ranges from 200% to 25000% of the width of the tubular member along a transverse axis. In some cases, the length of the tubular member ranges from 2 cm to 40 cm, such as from 5 cm to 30 cm or from 8 cm to 15 cm. An outer cross section, e.g. outer diameter, of the tubular member can range from 1 mm to 40 mm, such as from 2 mm to 20 mm, or from 4 mm to 8 mm. Tn some cases, the middle wall has a thickness ranging from 0.2 mm to 2 mm, such as from 0.5 mm to 1 mm. [00116] In some cases, the distal end can be beveled to expand the cross-sectional area of the lumen opening. The bevel, or chamfer, can have an angle of 10 to 90 degrees (the typical angle of 30 and 50 degrees ) and length of 0.5 to 5 mm (typical length of 1-3 mm).

[00117] In some cases, the wall of the distal sheath end can have a tapered contour for an edgeless transition to a telescoping trocar.

[00118] In some cases, the proximal end comprises a flange that has a larger cross section than a cross section of the middle wall. In some cases, the sheath includes a handle that is attached to the flange. In some cases, the flange can be attached to self-retaining retractors including articulating arms to stabilize the sheath without active user involvement.

[00119] As discussed above, the lumen of the sheath is defined by the proximal opening, the middle wall, and the distal opening. As used herein, the term “through-hole” refers to openings wherein there are two or more openings that connect an internal space to an exterior space. Since the internal lumen is connected to the outside space through two openings, each of the openings can be considered a “through hole”. Thus, the sheath has a proximal through-hole opening and a distal through-hole opening. In contrast, the term “blind hole” is used herein to refer to an opening when there is only a single opening that connects an internal space to an exterior space.

[00120] In some embodiments, the sheath is made of rigid material. This is convenient to maintain a stable spatial relationship between fiducial markers to have precise alignment with the set trajectory during advancement through the human tissues. The rigid nature of the material will enable pitching of the sheath inside the human body to reach a larger cone of access within the target. This can be beneficial when the sheath is introduced in the head through burr holes substantially similar in size to the outer diameter of the sheath.

[00121] The sheath can be made of any or a combination of metals (for example aluminum) or plastic including acrylic, vinyl, polyvinyl chloride, polycarbonate, polyethylene terephthalate glycol, nylon, Pebax, PEEK, polyolefin, fluoropolymers (including PTFE) and other compounded resins.

[00122] In some embodiments, the sheath is made of a transparent material to enable see-though visualization of the surrounding tissues. This can be beneficial to visualize clot matter around the sheath. In some embodiments, antireflection coatings or materials including silicon nitride (SiNx) and titanium dioxide (TiO2) films can be used to minimize reflection.

[00123] In some embodiments, the wall of the sheath or other sheaths are made of optically transmissive materials to transmit and distribute the light inside the tissue by total internal reflection as a light pipe or light tube. In these embodiments, refractive index can be constant or change gradually or in step- wise fashion to create distinct segments along the length, ID and OD of the sheath. Similarly, cladding layers can be applied in the inner diameter (ID), outer diameter (OD), a combination thereof in at least a segment of the light pipe. Light pipes can be beneficial to illuminate along the sheath and distal to the sheath with an external light source that is not occupying cross-sectional space.

[00124] In some embodiments, the access within the target can be expanded by including deflectable, steerable, or articulating segments of the sheath. Deflection (e.g., steering) refers to the movement of the distal tubular segment (e.g., the end) independent of the rest of the sheath. Steerability refers to the ability to rotate the distal tubular segment (e.g., clockwise and/or counterclockwise with respect to the rest of the sheath) by torque transmission along the length of the device. The torque causing the deflection can be transmitted by one or more shafts connected to a pull or anchor ring near the device tip. The distal tubular segment rotates one or more directions (e.g., rotational, or flexing within a plane) upon actuation and return to the original shape (e.g., linear). The deflection can be symmetrical, asymmetrical, loop curves, or compound. Deflection can occur in one or more planes and be on plane and off planes. In these embodiments, advancement to target under fluoroscopy is typically performed with the system in a rigid state, and upon entry in the target the system it can be actuated to deflect, steer and articulate to expand the lateral reach.

[00125] In some cases, the tubular member of the sheath has an inner diameter of 6 mm or less. [00126] In some cases, the tubular member has a larger outer diameter in a proximal segment to facilitate ergonomic handling and movement and to prevent unwanted entrapment of the sheath inside the skull.

Fiducial alignment elements

[00127] In some cases, the alignment element is a fiducial alignment element. For instance, the alignment element can include a proximal fiducial marker at the proximal end and a distal fiducial marker at the distal end. Such a sheath can be referred to as a sheath for determination of three- dimensional spatial orientation and removal of hemorrhagic blood from a body region of a patient, the sheath comprising a tubular member comprising: a proximal end comprising and a proximal fiducial marker and a proximal opening; a distal end comprising and a distal fiducial marker and a distal opening; a longitudinal axis extending from the proximal opening to the distal opening; a middle wall extending from the proximal opening to the distal opening; and a lumen defined by the proximal opening, the middle wall, and the distal opening.

[00128] The fiducial markers are configured to be visible in an image. Such fiducial markers are well known in the art, such as United States Patent 7,957,807, which is entitled “Vascular Fiducial markers”. For example, the fiducial markers can be fluoroscopic markers (FM) (e.g. X-ray fluoroscopic markers) or magnetic markers (e.g. magnetic resonance imaging (MRI) markers). In other cases, the fiducial markers are optical markers in an optical tracking systems, e.g. as described by Preim et al (“Chapter 18 - Image-Guided Surgery and Augmented Reality”; doi: 10.1016/B978-0-12-415873-3.00018-3).

[00129] The shape, design and location of the fiducial markers is selected to aid in the visual identification of the three-dimensional trajectory of sheath. FM designed for a 3D spatial orientation in a cartesian system with X- Y -X are used in fluoroscopic stereotaxis targeting. For example, the insertion assembly could have a proximal and a distal FMs and each comprise an open-circle cross-section, e.g. as shown in the top two embodiments of FIG. 7. If an X-ray image is recorded and the longitudinal axis is aligned with the central beam of the X-ray machine, then the two circles from the two FMs will be concentric. As shown in the top FIG. 7 embodiment, if both fluoroscopic markers have the same diameter, then a single circle will appear on the X-ray image since the distal fluoroscopic marker is behind the proximal fluoroscopic marker. However, if the longitudinal axis is positioned at an angle relative to the central beam of the X-ray machine, then the image will show two circles that are not concentric. Hence, the X-ray image can be used to determine the relative angle of the sheath.

[00130] As another example, the second embodiment of FIG. 7 shows two concentric circles where one circle is smaller than the other circle. For example, the distal fluoroscopic marker can have a smaller diameter than the proximal fluoroscopic marker. Hence, if the sheath is aligned with the X-ray machine, then the image will show two different circles with the same center point. In contrast, misalignment will give two circles that are not concentric, and the inner circle might even touch or extend beyond the outer circle.

[00131] Any other suitable combination of shapes of fluoroscopic marker can be used. For example, as shown in FIG. 7, one fluoroscopic marker can be a closed-circle. In another embodiment, one fluoroscopic marker can have a “cross shape” with two perpendicular lines, and proper alignment will give an image where the cross lines touch but do not extend past the circle in all four directions.

[00132] In another embodiment, the fluoroscopic marker can be shaped as an arrow distally (conical tip) and as a ring proximally. This combination facilitates the identification of the entry point in the head surface and the alignment of the sheath to the central ray of the beam.

[00133] In another embodiment, the material of the sheath can have sufficient radio-opacity to act as a circular radiomarker when its longitudinal axis is aligned to the central x-ray beam. For example, a sheath made of polycarbonate with a 1mm thickness, and inner diameter of 6mm and a length of 10cm creates a ring-shaped fluoromarker with sufficient contrast in the fluoroscopic display when its longitudinal axis is aligned to the central x-ray beam while imaging a human head. [00134] In other embodiments, radio-opaque substances (for example iodine, barium, tantalum, bismuth and gold) can be added to any of the material of the sheath to enhance radio-opacity).

Laser alignment element

[00135] In some cases, the alignment element comprises a laser alignment element located at the proximal end of the tubular member. Such sheaths can be referred to as a sheath for simple determination of 3-dimensional spatial orientation and removal of hemorrhagic blood from a body region of a patient, the sheath comprising a tubular member comprising: a proximal end comprising a proximal laser alignment element and a proximal opening; a distal end comprising a distal opening; a longitudinal axis extending from the proximal opening to the distal opening; a middle wall extending from the proximal opening to the distal opening; and a lumen defined by the proximal opening, the middle wall, and the distal opening.

[00136] Laser alignment elements can be disposed perpendicular, parallel or a combination thereof to the longitudinal axis of the sheath. When two perpendicular lasers following the X and Y planes intersect (or cross) between them and with the central x-ray beam following the Z plane, the projection of the lasers into the perpendicular or parallel alignment element can be used for 3D orientation and trajectory tracking. Perpendicular laser alignment element includes surfaces, orientation lines, flanges, wings, grooves, or ridges perpendicular to the longitudinal axis of the sheath and typically at the proximal end of the sheath. These elements can be equal to or larger than the outer diameter of the size of the sheath. Laser alignment elements can be disposed over a plane surface or a tridimensional shape, including but not limited to conical shape, concave conical shape, convex conical shape, dome shape, pyramidal shape, helm shape, cross gable shape, and tent shape. Laser alignment elements in tridimensional shapes enable orientation of the insertion assembly in X-Y-Z cartesian system.

[00137] In another example, the laser alignment element can be longitudinal and include at least a pillar extending proximally along the longitudinal axis. The laser alignment element can include orientation lines of one or more colors, surface texture, depressions or elevations in form of the pillar. Thus, the pillar extends outwards and away from the remainder of the tubular member. Such an embodiment is shown in FIG. 34. In some cases, two perpendicular laser lines oriented in X-Y planes are projected to cross the pre-selected entry and target points in the human body surface. Alignment of the laser alignment element of the sheath with the crossing lasers provides the trajectory in a X and Y plane. In some cases, the laser alignment element also includes two or more alignment markings. For example, these markings can be concentric rings that are concentric with the pillar. The markings can correspond to the transverse distance between the center of the pillar and the alignment markings. Such embodiments are shown in FIGS. 35 and 36. As discussed below, laser light from a laser light source can be projected towards the laser marking element, such as the pillar. The laser light can be projected along the desired trajectory. As such, if the pillar is aligned with the desired trajectory, the pillar will not create any shadows by blocking the laser light. However, a misalignment between the laser light and the pillar will cause the pillar to create shadows. These shadows can be compared to the two or more alignment markings, where the markings quantitatively indicate the degree of misalignment. This helps the surgeon adjust the angle of the sheath towards the desired trajectory.

[00138] The sheath can also include a handle. For example, the handle can be attached to the sheath at or near the proximal end.

TROCAR

[00139] Provided by the present disclosure are trocars for determination of three-dimensional spatial orientation and removal of hemorrhagic blood from a body region of a patient. Provided is a trocar comprising a tubular member comprising: a proximal end comprising a proximal opening; a closed distal end; a spatial alignment element; a longitudinal axis extending from the proximal opening to the distal opening; a central wall extending from the proximal end to the closed distal end; and a lumen defined by the proximal opening, the central wall, and the closed distal end.

[00140] Whereas the sheath discussed above had a distal end comprising a distal end, the trocar has a closed distal end. Whereas the sheath discussed above had a lumen defined by proximal opening, the middle wall, and the distal opening, the trocar has a lumen defined by the proximal opening, the central wall, and the closed distal end. The term “lumen” is used interchangeably with the term “internal lumen” herein.

[00141] As discussed above, an opening can be either a “blind hole” or a “through-hole” depending on how many openings connect an internal space to an external space. Since there is only a single opening that connects the internal lumen of the trocar to the exterior space, then the proximal opening of the trocar is a “blind hole proximal opening”.

[00142] In some cases, the closed distal end extends more distally than the middle wall section. In some cases, the closed distal end extends 1mm or more in the distal direction than the middle wall section. The distal and proximal directions are defined as opposite directions along the longitudinal axis. In some cases, the closed end has a conical shape. In some cases, the closed, conical closed distal end makes an angle of between 110° and 170° with the central wall. [00143] In some embodiments, the trocar has a sharp cone or pencil-shaped tip to enable puncture like incision in the dura and brain surface. The tip can have cutting features. Angles perforate the dura range from 10 to 90 degrees, typically 30 to 50 degrees. In some embodiments, the tip can be radio-opaque to act as a FM for fluoroscopic guidance. In some embodiments, the FM tip can be shaped like a 3D conical arrow vector to be seen as an arrow pointing the entry point in the head under fluoroscopy, and perforate through dura and brain during advancement to the target.

[00144] In some embodiments, the trocar tip has other cutting geometries including pyramidal bevel, back bevel, spear bevel, lancet bevel and spatula bevel.

[00145] In some embodiment, the tip of the trocar is made of an electrically conducive material (such as stainless steel, nitinol, or platinum iridium) and electrically coupled to an electrosurgical generator (such as an electrically conductive wire, or hypotube) to cut and coagulate soft tissues including dura and brain and to obtain hemostasis.

[00146] In some cases, the trocar further includes a handle attached to the central wall or the proximal end. The trocar’s handle can have all of the features of the handle discussed above with regard to the handle of the sheath.

[00147] In some cases, the proximal end comprises a flange that has a larger cross section than a cross section of the central wall.

[00148] In some cases, the trocar includes both the tubular member and a handle attached to the tubular member. For clarity, it is noted that the proximal end, distal end, and middle wall are all parts of the tubular member, wherein the tubular member is a part of the sheath.

[00149] In some cases, the spatial alignment element of the trocar can be a fiducial alignment element or a laser alignment element. The spatial alignment element of the trocar can have any of the same features described above regarding the spatial alignment element of the sheath. For example, spatial alignment element of the trocar can be a fiducial alignment element, such as a fluoroscopic alignment element. In some cases, the fluoroscopic alignment element includes a proximal fluoroscopic marker at the proximal end and a distal fluoroscopic marker at the closed distal end. In some cases, the spatial alignment element includes a laser alignment element, e.g. as discussed above.

[00150] In some embodiment, the trocar has one or more longitudinal pillars. This configuration is beneficial to decrease the friction between the trocar and the inner surface of the sheath while maintaining alignment and providing stiffness. In some of these embodiments, the trocar can be made of a material with sufficient radio-opacity to act as a fluoro-marker when its longitudinal axis is aligned to the central x-ray beam. For example, a trocar with 4 longitudinal pillars equally distant in its circumference will be seen as a cross-shaped marker in the fluoroscopic display when its longitudinal axis is aligned to the central x-ray beam while imaging a human head. INSERTION ASSEMBLY

[00151] Provided by the present disclosure is an insertion assembly that includes a sheath and a trocar as discussed above. The sheath and trocar are dimensioned for insertion of the trocar into the sheath. In some cases, the outer diameter of the central wall of the trocar and the inner diameter of the middle wall of the sheath are configured such that the trocar can be inserted into the lumen of the sheath, e.g. while causing friction between the middle wall and central wall.

[00152] When the assembly is assembled, the trocar is inserted into the lumen of the sheath. In other words, the majority of the central wall of the trocar is located within the lumen of the sheath. In some cases, the central wall of the trocar exerts an expansive force on the middle wall of the sheath, e.g. thereby causing a friction between the sheath and trocar. As such, this friction allows the two pieces to be moved simultaneously. Stated in another manner, the relative longitudinal distance between the trocar and sheath can be temporarily locked.

[00153] In some cases, the proximal end of the trocar comprises a flange that has a larger cross section than the cross section of the central wall of the trocar, wherein the flange has a larger cross section than the proximal end of the sheath, thereby preventing complete insertion of the trocar into the sheath. Also, the trocar can be removed from the sheath by grabbing and pulling on the flange.

[00154] In some cases, the trocar has a segment proximal to the tip with an outer diameter substantially similar to the inner diameter of the sheath to minimize tissue dragging during advancement. The trocar can have one or more segments smaller than the inner diameter of the sheath to decrease friction between these two telescoping elements resulting in easier insertion and removal. The trocar can have a handle to orient the longitudinal access under fluoroscopy without resulting in irradiation to the operator. The trocar can have a lumen along its longitudinal access for placement of a stylet for optical tracking.

[00155] One or more fiducial alignment elements and laser alignment elements can be disposed in one or more of the components of the insertion assembly.

DRILL GUIDE

[00156] Provided by the present application is a drill guide for determination of three- dimensional spatial orientation. The drill guide can include a tubular member comprising: a proximal end comprising a proximal opening; a distal end comprising a distal opening; a spatial alignment element; a longitudinal axis extending from the proximal opening to the distal opening; a core wall extending from the proximal opening to the distal opening; and a lumen defined by the proximal opening, the core wall, and the distal opening.

[00157] In some cases, the drill guide further comprises: a locking mechanism to maintain the selected longitudinal trajectory of the lumen; an anchoring mechanism between the drill guide and the skull to maintain their 3D relationship stable; and a spatial alignment element including one or more ball joints, one or more articulating arms, one or more adjustable-height spikes, or a combination thereof.

[00158] The drill guide can be used for frameless, image-guided three-dimensional orientation and trajectory usage of elongated devices including drill, sheath, catheter, needle, and a trocar. The drill guide can have any of the features discussed above regarding the sheath, e.g. fiducial markers, fluoroscopic markers, a laser alignment element, and a handle. As demonstrated in FIG 31A-B, in some embodiments the drill guide has a base designed to be anchored to the surface of a patient’s skull with screws. The base is designed to be temporary coupled with a guider by actuation of a locking element (herein “locker”). In typical use depicted in FIG. 32, the alignment element can be used to orient the drill guide lumen into the desired orientation following the visualization of imaging markers as previously described (markers of the drill guide itself, or markers of the sheath or the trocar by temporarily introducing these elements in the drill guide lumen). Then, the trajectory can be secured by actuation of a locking mechanism including bolts, fasteners, clamp, screw knobs, bars, chains, or latches. In some embodiments, male and female thread fitting are coupled between the drill base and the locking element. The thread fitting can be continuous or interrupted, and vertical or oblique (tapering inwards or outwards). Combining interrupted and tapering thread can result in progressing decrease in diameter of the base lumen and tightening of the drill guider in a certain position.

[00159] Then, the distal tip of a drill bit can be inserted through the lumen of the drill guide so that it exits the distal opening of the drill guide. Then, the drill can be activated, causing the drill bit to rotate, thereby cutting into the skull of the patient at the desired angle. In some embodiments of the drill guide, the inner diameter of the lumen is at least 0.3mm (typically 0.5mm to 2mm) larger than the diameter of the drill bit to minimize unnecessary friction. In some embodiments, a distal segment of the drill guide has a larger lumen compared to the rest of the drill guide. This distal segment is design to function as a ball joint with a receiving socket for spatial alignment (by enabling roll, yaw and pitch), and to collect bone chips and bone dust during drilling process to minimize unwanted resistance. FIG. 31 A-B show a receiving socket for helping to align a sheath, trocar, or drill guide with the designed trajectory.

[00160] In some cases, the drill guide can include surface attachment arms that are connected to the core wall or proximal end. In some cases, these surface attachment arms can give drill guide an appearance similar to a spider, i.e. wherein the surface attachment arms are the legs of the spider.

[00161] In some cases, the drill guide includes a ball-and-socket joint, as shown in FIGS. 45 A- 45C. Such a drill guide will include a rotatable turret with a spherical ball (i.e., a spherical end) located at the bottom end and a base with a spherical socket for receiving the ball. In some instances, the bottom surface of the base can be curved to accommodate the curvature of the body surface of the patient, such as the skull, as shown in FIG. 45E. The turret can be locked into a particular configuration by a locking collar, e.g. wherein FIG. 45F shows a locking collar.

BLOOD REMOVAL DEVICE

[00162] Also provided by the present disclosure is a device for removing hemorrhagic blood from the body region of the patient. In the invention herein, the clot evacuation or removal device is also referred as clot minimally invasive neuro-evacuator (MINE) device. In some cases, the blood removal device includes: a barrel comprising a proximal end, a distal end, an irrigation channel extending from the proximal end to the distal end, and a suction channel extending from the proximal end to the distal end; a camera positioned at the distal end of the barrel; a handle coupled to the proximal end of the barrel; an activator of irrigation; and an activator of suction.

[00163] In some cases, the device includes a housing and the housing serves as a handle. In such cases, the device can be described as including a barrel, a camera, an activator of irrigation, an activator of suction, and a housing comprising a handle.

[00164] The area of the barrel that is located between the proximal end and the distal end can be referred to as a middle section of the barrel.

[00165] In some cases, the device including a lighting element, e.g. a light bulb positioned at the distal end of the barrel. The light bulb can be incandescent, fluorescent, a light emitting diode (LED), or any other suitable technology.

[00166] In some cases, the device includes a visual display operably connected to the camera. For instance, the device can include a small computer monitor mounted to a housing of the de vice, as shown in FIG. 10. In other cases, the device lacks a visual display (e.g. as shown in FIG. 46A), and instead the pictures or video from the camera are transmitted to a separate computer screen, such as the screen of a computer monitor sitting on a desk. [00167] As shown in the second panel of FIG. 46A, in three-dimensional space, the device has a “proximal direction” which is towards the patient and a “distal direction” that is away from the patient, and which aligns with the longitudinal axis of the barrel. The proximal-distal axis can also be referred to as a “horizontal axis”. Accordingly, there is also a “vertical axis” that is perpendicular to the proximal-distal horizontal axis.

[00168] For instance, an exemplary device is shown in FIG. 10.

[00169] In some embodiments, the insertion assembly or the drill guide can have positional indicators and/or sensors, including tilt sensors, levels (bubble level, plumb level), horizontal directional Gyro, VOR receiver, a horizontal situation indicator, and or an attitude indicator situation indicators. A radio range station can be part of the headholder, the angiosuite table or the imager system.

[00170] As used herein, the terms “blood”, “hemorrhagic blood”, and “hemorrhaged blood” are used interchangeably herein to refer to liquid blood, partially coagulated blood, fully coagulated blood, and combinations thereof. As skilled artisans are aware, coagulation changes blood from a liquid state into a semi-solid or solid state. Thus, removing the “hemorrhagic blood” from the body region encompasses removing blood in a liquid, semi-solid, and solid states.

[00171] The barrel of the device can be cylindrical in shape or have a different shape, such as a three-dimensional rectangle or be elliptical in shape. Thus, the barrel can have a circular cross section, a square cross section, a rectangular cross section, or an elliptical cross section. The barrel has a proximal end and a distal end, e.g. which are the two ends of its cylindrical shape. The barrel has a longitudinal axis, and the proximal and distal ends are located at either ends of the longitudinal axis. There are also transverse axes perpendicular to the longitudinal axis of the barrel. The proximal and distal ends and openings of the irrigation channel and suction channel are located at opposite ends of the longitudinal axis. In typical embodiments, the barrel has a shape and diameter to be introduced in the lumen of the sheath and be mobile in a longitudinal axis (even beyond the distal opening of the sheath) and rotational axis.

[00172] The barrel can be made of any of the materials herein described for the sheath.

[00173] In some embodiments, the barrel can be introduced straight within the sheath, and have a distal segment capable of extending beyond the distal end of the sheath and bend, deflect, steer, or articulate. In some embodiments, at least a distal segment of the barrel can include an elastic material that is shaped with a curve. When this segment advances beyond the distal opening of the sheath and is unconstrained, it acquires a curved shape. This is beneficial to expand the lateral reach of the system in a transversal plane within the target hematoma while minimizing the size of the path across the skull and the brain tissues. [00174] The barrel includes at least an “irrigation channel”. In some embodiments, this irrigation channel is located along a top side of the barrel. The irrigation channel can be in fluid communication with an irrigation source that provides water or another aqueous liquid. Thus, activating the irrigation activator causes the irrigation liquid to move through the irrigation channel from its proximal opening at its proximal end to its distal opening at its distal end. Thus, the irrigation water exits that barrel and can contact the tissues and hemorrhaged blood at the destination site. Exemplary irrigation activators include buttons and triggers. The irrigation activator is activated by moving it from a passive state to an activate state, e.g. thereby opening a valve that causes the irrigation liquid to flow. In some embodiments, the fluid can be delivered through one or more openings at high pressure for hydrolytic cutting of clots. Openings are typically in the distal most segment of the barrel or at the distal opening. Openings can be towards the lumen of the barrel, towards the outer surface of the barrel, towards the front of the barrel opening, or a combination thereof. In some embodiments, the distal opening of the irrigation channel is located substantially close to the camera tip and illumination elements to flush debris and blood that obscure vision.

[00175] The barrel also includes at least a “suction channel”. For example, the suction channel can be located on a bottom side of the barrel. Activating suction causes a vacuum force to pull material into the distal opening of the suction channel and towards the proximal opening of the suction channel. The material can then travel towards a waste receiving element, e.g. after passing through a suction channel within the handle. Exemplary suction activators include buttons and triggers. The applied vacuum can be continuous, dynamic, cyclical, pulsatile, at low and/or high frequency. Pulsatile pressure induces clot fatigue and fracture facilitating aspiration removal. Fluid drainage can occur spontaneously by a pressure gradient between the intracranial compartment and the atmosphere. Vacuum can be applied either using syringes or pump. In some embodiments, the suction channel is coupled to the atmosphere by an opening which diminishes or eliminated vacuum distally. In this embodiment suction can be modulated by partial or complete manual occlusion of the opening.

[00176] In some embodiments, the vacuum system is open to the atmosphere by a window. The window can be round, oval, square, drop shaped, elongated drop shaped. The window can be temporarily occluded by a finger resulting in increasing in vacuum power and resulting aspiration through the barrel. Occlusion can be partial resulting in modulated vacuum power.

[00177] In some embodiments, the suction and irrigation functions are provided through different lumens, i.e. the suction channel is a suction lumen whereas the irrigation channel is an irrigation lumen that is different from the suction lumen. In other embodiments, the suction and irrigation functions are provided through a single “suction-irrigation lumen”. [00178] In some embodiments, one or more components of the barrel assembly may include materials described herein for the sheath, and one others including stainless steel, nitinol, nitinol cobalt, silver, titanium, copper, cobalt chromium, nickel chromium, platinum iridium, polymer, nylon, polyamides, fluoropolymers, polyolefins, poly(tetrafluoroethylene), high density polyethylene, polyurethanes and polyimides, ceramic, bio-absorbable or dissolvable material, combinations thereof, and the like.

[00179] The device also includes an image module formed by a camera and a lighting element positioned at the distal end of the barrel. The camera functionality can be based in optical fibers, complementary-symmetry metal-oxide-semiconductor, scanning fiber endoscope or any other methods. The camera can be parallel to the longitudinal axis of the barrel, or have an angle toward the barrel’s lumen between 1 degree and 45 degrees (typically 10 degrees to 30 degrees). The optical system can be mounted 0mm to 20mm proximally from the distal end of the barrel. The optical system, light source and electric wire can be disposed partially or totally in the barrel wall. [00180] In some embodiments, the camara can be longitudinally moved relative to the barrel. In these embodiments, the camera can advance beyond the distal end of the barrel and be uncoupled to the barrel if needed. Is some embodiments, the camera can be deflectable, steerable, or articulating. In some embodiments, the camera shaft has a pre-set curved shape that is acquired when unconstrained by uncoupling from the barrel or advancing beyond the distal opening of the clot evacuation device or sheath. Torquing the curved shaft of the camara will result in expanded view.

[00181] To provide illumination for the camera, the device includes at least one lighting element. For example, the lighting element can be a light source positioned at the distal end of the barrel. Exemplary lighting sources include light emitting diode (LED) lights. In other cases, the lighting element includes a light pipe. The light pipe receives light from at a proximal end of the light pipe, transmits the light through a middle section of the light pipe, and the light exits from a distal end of the light pipe. The light moves through the light pipe through total internal reflection.

[00182] In some cases, the distal end of the barrel is tapered, e.g. at an angle of 10° to 85°, such as from 25° to 65°. For example, FIG. 10 shows a distal end tapered at about 45°. For example, due to the tapering, a top section of the distal end is located more proximally than a bottom section of the distal end. As shown in FIG. 10, in some embodiments the light and camera can be positioned on the side of the bevel. As such, the camera can look forward while still observing the opening to the suction channel, thereby providing a technical advantage.

[00183] In other embodiments, the light and camera can be positioned on the opposite side of the bevel. For example, in embodiments including a transparent barrel with an OD of 6mm and a thickness of 1mm, a camera with a 0 degree to 30 degree angle can be located 1mm to 15mm proximal to the apex of the bevel (typically 2mm to 6mm). As such, the lumen and opening of the barrel can be visualized at least partially through the wall of a transparent barrel along with the relevant visual targets in front of the barrel. The proximal location of the imaging system maintains a clot-free space that minimizes the risk of soiling and consequent poor visualization, which is further expanded by a beveled opening.

[00184] Barrels with a tapered (beveled) distal opening herein described provide distinct benefits for the current embodiment including larger area and force, oblique pressure gradient and differential contours of velocity magnitude and velocity vectors.

[00185] The beveled configuration of the distal opening of the barrel when connected to a vacuum source will result in a steep oblique pressure gradient that can improve thrombus ingestion by compressing and rolling in the thrombus.

[00186] The beveled configuration of the distal opening of the lumen of the barrel when connected to a vacuum source will result in a high velocity magnitude and velocity vectors at the base of the bevel which maintains clots and blood away from the camera when mounted in the opposite direction (apex of the bevel). The differential augmentation in flow can facilitate clot removal, clot and blood clearance by delivering fluid, and approximate bleeding vessels to an electro-coagulating electrode located at the base of the bevel.

[00187] Delivery of saline solution substantially close to the imaging system (camera and light) or on the longer side of the bevel (apex) concurrent with vacuum in the barrel lumen will result in a directional flow of saline away from the camera, around the apex of the bevel, and into the lumen of the barrel. This forced fluid path will maintain blood and clots away from the imaging system, flush the camera when soiled, and clean the inner surface of the barrel to enable see-through visualization of the barrel lumen after clot ingestion.

[00188] Clearance between the OD of the barrel and the ID of the sheath can be 0. 1mm to 3mm. The combination of a clearance of 0.1mm to 1mm and delivery of saline solution from a reservoir pressurized at 200mmHg to 350mmHg, delivered via an irrigation channel with an length of 5cm to 20cm along a barrel and an area of 0.5mm² to 5mm² provides sufficient volume and pressure to expand the resection cavity and prevent brain tissue collapse during clot removal. The clearance also provides an escape path for the fluid delivered at the tip of the barrel to prevent supraphysiological pressures when the device is not on active suction.

[00189] The device also includes a handle coupled to the proximal end of the barrel. For instance, the handle can be oriented perpendicularly to the longitudinal axis of the barrel. The handle can also include one or more curved surfaces configured to accommodate one or more fingers of a user. These curved surfaces help make the device easier for a surgeon to hold and manipulate. The handle can include a top section that is attached to the proximal end of the barrel, e.g. as shown in FIG. 10.

[00190] The device also includes a visual display operably connected to the camera. For example, the visual display can be located adjacent to the proximal end of the barrel and the top section of the handle, e.g. as shown in FIG. 10. The display can be fixed or mountable, and have an articulation to change the angle compared to the device. For example, the visual display can be a flat-panel display such as a light-emitting diode (LED) display. The visual display can display the visual display from the camera in either black-and-white or in multiple colors. In some cases, the visual display has a screen area ranging from 25 cm² to 500 cm², such as from 50 cm² to 250 cm². The device can also include an image export element, such as a Universal Serial Bus (USB) port or a Secure Digital (SD) card port. Such elements can be used to transfer images or video recorded by the camera to another electronic device.

[00191] The device can also include a cutting element positioned within the suction channel at the proximal end. Such devices will also include a cutting element activator. The cutting element can also be referred to as a “clot cutting element” or a “clot cutter”. The clot cutter can be an element that moves in a manner that cuts an object located at the distal opening of the suction channel. For example, the clot cutter can be positioned on the top side of the suction channel, and activation causes the clot cutter to move downwards into the channel and contact the bottom of the suction channel, thereby cutting clot or other material within its path, e.g. as shown in FIGS. 17 and 21.

[00192] In some embodiments, clot cutters can include loop wires actuated by pull/push wires longitudinally disposed along the wall of the barrel. The loop wires can have hinges and swipe the barrel’s lumen, reversibly move into and out of the suction channel or the distal barrel opening to thereby drag material into the channel, thereby cutting it, as shown in FIG. 18 A. In some embodiments, the clot cutter is formed by a tongue that moves into and out of the suction channel. The advancement if the tongue across the lumen of the barrel can be at the distal opening, 0.1mm to 10mm distal to the distal opening, and 0.1 to 10mm proximal to the distal opening. The trajectory o advancement can be linear, curve, or a combination. The trajectory of advancement of the tongue across the lumen of the barrel can be parallel or non-parallel to the distal opening of the barrel. These embodiments are beneficial to maximize the luminal diameter of the barrel. In some cases, the clot cutter rotates around the longitudinal axis at the opening of the suction channel, as shown in FIGS. 18A-18C, thereby cutting material at the opening.

[00193] In some embodiments, the clot cutter has the configuration of a plunger, brush, arrowhead, disk, balloon, impeller, auger, an Archimedes screw or a shaft. In some embodiments, the shaft has a straight or shaped configuration, such as “J”, “L”, “S”, sinusoidal, “T”, or other eccentric shapes and can move in one or a combination of linear translation, vibration, spinning, and orbiting. In another embodiment, the shaft has an eccentric mass at the distal end to augment the mechanical energy delivered to agitate the particulate matter. The eccentric mass can also be a cutting element to macerate the particulate matter. In alternative embodiments, the shaft distal end has an expandable element, which can be expanded manually such as inflating a balloon or unsheathing a self-expanding stent or expand due to centripetal force under rotational motion.

[00194] Cutting elements can be manually powered, or include a drive system (formed by one or more motors) for driving translation and/or rotation.

[00195] In some cases, the cutting element includes magnets and/or electromagnetic actuators.

[00196] In some cases, the cutting element comprises two electrodes located at the distal end of the suction channel, wherein the cutting element activator causes a voltage to be applied between the two electrodes. Such an embodiment is shown in FIG. 20.

[00197] In some embodiments, the device further includes an electrocoagulation element comprising first and second electrocoagulation electrodes that are both located at the distal end of the barrel. Applying an electrical voltage between such electrodes can be used to coagulate blood and slow or stop bleeding from a blood vessel or brain structure. Such electrocoagulation during surgery is a well-known procedure in the art. For example, Howe et al. describes electrosurgery as a method of causing coagulation to limit bleeding during surgery (Journal of the American Academy of Dermatology, 2013, 69, 5, 677.el-677.e9, doi: 10.1016/j.jaad.2013.07.013).

[00198] In some embodiments, the advancing tongue of the clot cutter has an electrode at the distal end that upon advancement approximates within 2mm or less to a static electrode at the apex. Each electrode is electrically coupled by an electrosurgery generator. The tongue can have a shape substantially similar to the shape of the barrel’s distal opening to maintain equidistance between the two approximating electrodes. This small and equal distances facilitates efficient electrocoagulation, and help positioning bleeding vessels between the approximating electrosurgery electrodes especially when concurrent with vacuum in the barrel. The advancement of the dynamic electrode from the bevel base to the bevel apex also moves the bleeding vessels into the visual field of an imaging module located on the side of the fix electrode (bevel apex). In some embodiments, the electrodes are configurated to deliver electrosurgical energy at the apex of the beveled barrel to coagulate tissues in front of the device.

[00199] In some embodiments, elastic bands can be delivered at the distal end of the barrel to strangulate bleeding vessels and facilitate hemostasis. The elastic bands can be rear-end or front-end mounted, and deployed by actuating a string system that pulls the band forward to the front end of the barrel, or a pushing system that pushes the band toward the front of the barrel. Elastic bands can be released concurrent to vacuum which will pull the bleeding vessels into the barrel lumen facilitating band placement and hemostasis.

[00200] As discussed above, in some cases, the activation elements for the irrigation, suction, and cutting element are triggers or buttons. Activation buttons can be changed from a passive state to an active state by depressing the button, i.e. by moving it translationally. Activation triggers can be changed from a passive state to an active state by rotating the trigger, i.e. wherein one end of the trigger is in a fixed location and force on the trigger causes it to rotate. FIG. 10 shows an irrigation trigger in the front, a suction trigger in the middle, and a cutting activator in the back on the handle. One or more of the activation elements can be configured and dimensioned to be activatable by a single human finger, improving the ease of using the device, e.g. as shown in FIG. 10.

[00201] Additionally, two or more of the “activation motions” can be coplanar with each other, i.e. each of the motions are located in the same plane. As discussed above, the activation motion for a trigger is rotation whereas the activation motion of a button is depressing the button. Furthermore, in some cases the device includes a “trigger guard”, which can be used with triggers, buttons, or a combination. The trigger guard is adjacent to the activators to protect them from accidental activation. In some cases, the trigger guard is coplanar with the activation motions, e.g. as shown in FIG. 10.

[00202] In some embodiments, the handle has one or more input or output connections including tubes for vacuum or saline and wires for power supply, video display or recording, and electrosurgery. In some embodiments, the handle is connected with a digital controller, for example for video display, capture and storage, image focus, white balance and light intensity. [00203] In some cases, the blood removal device includes one or more features shown in FIGS. 46A-E, 47A-I, 48A-C, or 49.

[00204] In some cases, the device includes a cutting element and an activator of the cutting element (i.e. a cutting element activator). In some cases, the device includes a cutting element channel extending from the proximal end to the distal end, wherein the cutting element extends from the proximal end, through the cutting element channel, to the distal end. For instance, the cutting element channel can be located below the suction channel. Related embodiments are shown in FIGS. 48 A.

[00205] In some embodiments, as shown in FIG. 48B, the cutting element comprises a cutting edge located at the distal end, a neck adjacent to the cutting edge, and a central section located adjacent to the neck, wherein the neck has a smaller cross section than a cross section of the central section and a cross section of the cutting edge. In some cases, activating the activator of the cutting element causes the cutting element to move in the distal direction and the cutting edge to move upwards in front of the suction channel and contact another part of the barrel, as shown in FIG. 48A.

[00206] In some cases, the device includes a main opening located at the distal end of the barrel, e.g. wherein the distal end of the suction channel is located inside the main opening, e.g. as shown by a comparison of FIG. 46B and 48A and 49. In some cases, main opening has a top edge and a bottom edge, wherein the top edge of the main opening is located more distally than the bottom edge of the main opening, as shown in FIG. 49. Additionally, the device can include an auxiliary opening located at the distal end of the barrel, wherein the camera is positioned at the auxiliary opening, as shown in FIG. 49 and 48 A and 46B. The auxiliary opening can be located more proximally than any part of the main opening, and the distal end of the irrigation channel can be located at the auxiliary opening. In some cases, there is a horizontal surface located between the auxiliary opening and the main opening, as shown in element 4803 in FIG. 48A.

[00207] An exemplary device is shown in FIG. 46A, which can have depressible irrigation button 4606, and a trigger 4605 and handle 4604. In some instances, there is a located: (i) at a top surface of the handle, and (ii) within the proximal half of the handle, wherein the irrigation button is the activator of irrigation (e.g. saline solution) or the activator of suction. As shown in FIGS 47A, B, and C, the irrigation button is coupled to a lower pinch boss (e.g. element 4714), which is positioned adjacent to a first tube 4715 within the handle. The irrigation button is pushed upwards until the lower pinch boss gets locked with the upper pinch boss. In this position, the first tube is compressed between the upper pinch boss of the handle (e.g. element 4713) and the lower pinch boss of the irrigation button (e.g. element 4714). As shown in FIGS. 47A, B, and C, the depressible button can be connected to a first pinch boss located adjacent to a first tube inside the handle, wherein moving the depressible button moves the first pinch boss, thereby compressing or releasing compression of the first tube. In some instances, the depressible button is the activator of irrigation, wherein the first tube is connected to the irrigation channel, wherein depressing the depressible button releases compression of the first tube and causes irrigation liquid to flow into the irrigation channel. Also, the device can include a complementary first pinch boss that is located on an opposite side of the first tube from the first pinch boss, and thus the first tube can be compressed between the first pinch boss and complementary first pinch boss, as shown in FIG. 47C. In some cases, the first pivot boss (e.g. element 4714) is part of a slider that is contact with a spring, e.g. which is located behind element 4716 in FIG. 47G. In a further embodiment, as illustrated in FIGS. 47G, H, and I, the irrigation button incorporates a latching mechanism configured to maintain continuous irrigation flow upon a single, sustained actuation. This latching mechanism comprises a hook (e.g., 4718) strategically located within a groove (e.g., 4719) integrated into the irrigation button or an associated component. [00208] Upon continuous pressing of the irrigation button, the hook engages with the corresponding groove within the irrigation button. This engagement results in a latching action that locks the irrigation button in an actuated position. In this latched state, the first tube is held in an open configuration between an upper pinch boss (e.g., 4713) located on the handle and a lower pinch boss (e.g., 4714) located on the irrigation button, permitting continuous fluid flow through the irrigation lumen.

[00209] A subsequent actuation (e.g., a second press) of the irrigation button disengages the latching mechanism. The hook is released from its engaged position, allowing the irrigation button to return to its original, non-actuated position. This action compresses the first tube between an upper pinch boss (e.g., 4713) located on the handle and a lower pinch boss (e.g., 4714) located on the irrigation button, effectively halting the irrigation fluid flow.

[00210]

[00211] As used herein, the term “pivot boss” is used interchangeably with “pivot element” to refer to any mechanical structure that allows another mechanical structure to rotate around it. The term “pinch boss” is used interchangeably with “pinch element” and refers to any mechanical structure that can exert pressure on a certain part of a secondary object. For example, the pinch boss can have a hemispherical surface that allows pressure to be exerted by the apex of the hemisphere onto another object, such as a tube. In other cases the pinch boss has a triangular side that allows pressure to be exerted by the apex of the triangle on the secondary object.

[00212] The device can include a trigger attached to and configured to rotate around a pivot boss, wherein: the trigger is an activator of suction or an activator of irrigation, the trigger is optionally an activator of a cutting element, the trigger has a home position, a first activation position, and a second activation position that are each defined by a particular angular rotation around the pivot boss, the trigger is located more proximally in the first activation position than in the home position, the trigger is located more proximally in the second activation position than in the first activation position.

[00213] The term “activator of suction” is used interchangeably with “suction activator” and “activator of irrigation” is used interchangeably with “irrigation activator”.

[00214] FIGS. 47A-F show the trigger 4701 and pivot boss 4702. The device can include a trigger spring the pushes the trigger in a distal direction and into the home position, which is shown as spring 4706. In some cases, the angular difference between the home position and the first activation position ranges from 5° to 45°, such as 5° to 15°. In some cases, the angular difference between the first activation position and the second activation position ranges from 5° to 45°, such as 5° to 15°.

[00215] In some cases, the trigger is connected to a second pinch boss located adjacent to a second tube inside the handle, wherein rotating the trigger around the pivot boss moves the second pinch boss, thereby compressing or releasing compression on the second tube, as shown in FIGS. 47C-D. In some embodiments, as shown in FIGS. 47C-D, the trigger is operatively connected to an upper pinch boss (4708) situated adjacent to a second tube (4707) inside the handle. The trigger’s pivotal movement around the pivot boss (e.g., 4710) causes a corresponding movement of the lower pinch boss (4709), which is configured to regulate the compression of the second tube, thereby regulating fluid flow. In some embodiments, the second tube is connected to the suction channel, wherein the trigger is an activator of suction and rotating the trigger from the home position to the first activation position causes the second pinch boss to release compression on the second tube and allow a suction force to be exerted through the suction channel. In some cases, the second tube remains in an uncompressed state upon moving the trigger from the first activation position to the second activation position or beyond the second activation position, as shown in FIG. 47F. There can also be a complementary second pinch boss located on an opposite side of the second tube, as shown in FIG. 47A, and thus the second tube can be compressed between these two pinch bosses. In some cases, the second pinch boss (e.g. element 4709) is a part of a slide (e.g. element 4704) that is in contact with a spring (e.g. the trigger spring, as shown in FIG. 47 A).

[00216] In some cases, the device further includes an “arm”, which can also be called a “push arm”, which is represented as element 4711 in FIG. 47A. Such devices will also include a “push element”, which can also be called a “push knob” or a “push receiver”, which is represented as element 4710 in FIG. 47 A. In such cases: the arm is attached to the pivot boss and the trigger, rotation of the trigger around the pivot boss causes rotation of the arm around the pivot boss by the same angular amount, the angle formed by the trigger, the pivot boss, and the arm ranges from 100° to 180°, the arm is not in contact with a push element when the trigger is in the home position or the first activation position, the arm contacts the push element upon rotation of the trigger from the first activation position to the second activation position, rotation of the trigger past the second activation position causes the arm to push on the push element and move the push element in a distal direction, the push element is connected to the cutting element such that movement of the push element in the distal direction causes the cutting element to move in a distal direction, thereby exerting a cutting force on material present at a cutting location at the distal end of the barrel. [00217] As stated above, rotation of the trigger around the pivot boss causes rotation of the arm around the pivot boss “by the same angular amount”. It is understood that mechanical mechanisms cannot be manufactured perfectly, and therefore “by the same angular amount” means angular displacements that are within 5% of each other, such as within 1% of each other. The angular displacement can be measured in degrees.

[00218] In some cases, the push arm and the trigger are different sections of a single object, and in other cases the trigger and push arm are different objects that are locked into a fixed angular relationship, e.g. wherein both are tightened under the pivot boss.

[00219] In some cases, the push element (e.g. element 4710 in FIG. 47 A) is part of a slider (e.g. element 4703) that is in contact with a spring (e.g. element 4705) that resists the distal movement of the push element. In other words, this spring pushes push element in a proximal direction.

[00220] FIG. 46A shows an exterior view of an exemplary device in the first panel. Also, the second panel of FIG. 46A shows a horizontal axis intersecting the proximal and distal ends of the barrel, along with a vertical axis perpendicular to the horizontal axis. In some cases, the device comprising a housing that surrounds one or more elements of the device, wherein the activator of suction, the activator of irrigation, and the optional activator of the cutting element are located at least partially outside the housing.

[00221] In some cases, the housing can be shaped for easy and secure grip by a single human hand. For example, the housing can be shaped similar to a handgun. Also, the activation buttons and triggers can be located for easy use by a single human hand. For example, the trigger can be located where the trigger of a handgun is located, as shown in FIG. 46A, thereby allowing easy operation by the index finger of a user. The button can be located at the top-distal end of the device, thereby allowing for easy use by the thumb of a user.

[00222] In some cases: a horizontal axis intersects the proximal end and the distal end of the barrel, a vertical axis is perpendicular to the horizontal axis, wherein the vertical axis also intersects the housing at one or more points, the housing includes a top section that encompasses part of the horizontal axis, the housing includes a vertical section that encompasses part of the vertical axis, the top section ranges from 1 cm to 5 cm in height and from 3 cm to 10 cm in width along the horizontal axis, the vertical section ranges from 4 cm in height to 9 cm in height and from 2 cm to 6 cm in width along the horizontal axis.

[00223] Such dimensions can render the device easily and securely holdable by a user.

[00224] In some cases, the housing can have an L-shape, wherein the trigger is located on the inside corner of the L-shape, and the button is located on the outside comer of the L-shape. The “L-shape” can be described as a central section that includes the origin point where the vertical axis intersects the horizontal axis, a forward section that extends distally from the central section, and a bottom section that extends downwards from the central section.

[00225] The device can also include one or more connections that exit a button section of the vertical section of the device. Exemplary connections include a suction conduit, an irrigation conduit, an electrical wire, a digital communications wire, or a combination thereof. FIG. 46E shows a bottom view of a device with such connections.

METHOD

[00226] Provided by the present disclosure are methods of removing hemorrhagic blood from a body region of the patient. The methods can be performed with the tools described above.

[00227] In some cases, the method includes: providing a sheath comprising: a proximal end comprising a proximal opening; a distal end comprising a distal opening; a longitudinal axis extending from the proximal opening to the distal opening; a middle wall extending from the proximal opening to the distal opening; and a lumen defined by the proximal opening, the middle wall, and the distal opening, optionally providing a trocar comprising: a proximal end comprising a proximal opening; a closed distal end; a central wall extending from the proximal end to the closed distal end; and a lumen defined by the proximal opening, the central wall, and the closed distal end, wherein a spatial alignment element is present as a part of the tubular member of the sheath or as a part of the tubular member of the trocar; forming an insertion assembly comprising the sheath and optionally further comprising the trocar inserted into the lumen of the sheath recording initial images of the hemorrhagic blood and the body region; selecting a desired trajectory for the insertion assembly from an entry site at an exterior surface of the body region to a destination site at the hemorrhagic blood based on the recorded images; optionally removing bone at the entry site using a drill and a drill guide; approximately aligning the longitudinal axis of the sheath with the desired trajectory; assessing the alignment between the longitudinal axis of the sheath and the desired trajectory based on a spatial alignment element of the insertion assembly; adjusting the sheath so that its longitudinal axis is more closely aligned with the desired trajectory based on the assessment; inserting the insertion assembly into the body region to a desired depth such that the distal end of the sheath reaches the hemorrhagic blood; if present, removing the trocar from inside the sheath; and removing at least some of the hemorrhagic blood from the body region through the sheath.

[00228] In the method recited above, the insertion assembly comprises the sheath and optionally the trocar. Thus, in some cases the insertion assembly only includes the sheath. In other cases, the insertion assembly includes both the sheath and the trocar, wherein the formation of the insertion assembly includes inserting the trocar into the lumen of the sheath.

[00229] In the method recited above, a spatial alignment element is present as a part of the tubular member of the sheath or as a part of the tubular member of the trocar. Thus, in cases wherein the insertion assembly only includes the sheath, there is a spatial alignment element that is part of the tubular member of the sheath. In cases wherein the insertion assembly includes both the sheath and the trocar, the spatial alignment element can be present in either the tubular member of either the sheath or the trocar.

[00230] The method includes recording initial images (with or without fiducials) of the hemorrhagic blood and the body regions, e.g. wherein the images are X-ray images or MRI images. The computational (e.g. fluoroscopic) images can be recorded with a flat panel detector or with CT scanner. Then the images are reconstructed in multiple planes and from multiple directions to determine the relative location and amount of hemorrhaged blood. In some cases, the initial images are fiducial images.

[00231] The method continues with the selection of a trajectory to reach the hemorrhaged blood. As will be apparent to skilled artisans, it is important to reach the blood without contacting or damaging vital tissues. Although the method can be applied to many different body regions, this is especially important if the blood is located within the brain. As such, the desired trajectory will begin at a certain entry site on the surface of the body region and end at a target site at the blood clot.

[00232] In some cases, images (X-ray or MR based) can be recorded after intravascular injection of contrast resulting in the inclusion of vascular structures in the multiplanar images used to plan a trajectory from an entry to a target point.

[00233] In some cases, the method includes the optional step of removing bone at the entry site using a drill and a drill guide. For example, if the hemorrhagic blood is located in the brain, the method can include the step of removing a section of bone from the skull of the patient, thereby exposing the tissue underneath. The removal of bone can be performed at any suitable time during the method. For instance, the bone removal can occur immediately before the approximate alignment, or it can occur even before the initial fiducial images. In some cases, in addition to removing bone at the entry site, the method further includes incising skin and soft tissue at the entry site.

[00234] The method includes approximately aligning the longitudinal axis of the sheath with the desired trajectory. When an airplane flies through the air, its direction can be quantified as its pitch and yaw. Similarly, the sheath has a pitch and yaw that must be aligned with the desired trajectory. For example, a surgeon can visually estimate the desired trajectory and hold the insertion assembly in an approximately accurate trajectory. In some cases, a handle can be present as a part of the sheath or the trocar. As such, the surgeon can hold the handle, thereby providing the advantage of greater stability and the advantage of removing the surgeon’s hand from the path of X-rays.

[00235] The method includes assessing the alignment of the longitudinal axis with the desired trajectory, e.g. which can be performed with fiducial markers (e.g. radiopaque markers for X-ray or MRI) or a laser alignment element. In some cases, the method includes performing a second assessment, e.g. if the initial alignment was relatively poor or if the body part has moved during bone drilling. In some cases, the method includes making a second adjustment based on the second assessment.

[00236] The method includes adjusting the sheath so that its longitudinal axis is more closely aligned with the desired trajectory. For example, the surgeon can have the insertion assembly with their hand.

[00237] The method includes inserting the insertion assembly into the body region to the desired depth. For example, the depth of insertion can be determined by measuring the location of the fiducial markers, or with depth indicators on an external surface of the sheath. Additionally, if the insertion assembly includes the trocar, then the closed distal end of the trocar can advantageously push the body tissue sideways, thereby clearing a pathway for the main section of the sheath.

[00238] After the desired depth is reached, the method includes removing at least some of the hemorrhagic blood. However, if the insertion assembly included the trocar, then the trocar is removed from inside the sheath by moving it in the proximal direction. Afterwards, the blood can be removed through the open lumen of the sheath.

[00239] In some cases, after obtaining images of the hemorrhagic blood and selecting a trajectory in the tomographic images, the method includes moving (e.g. roll, yaw, pitch) the head holder or operating table as necessary to convert the trajectory from entry point to target point into a vertical path across the head (i.e. perpendicular to the horizontal line). The head needs to be temporarily fixed to the head holder or table during acquisition of fiducial images and during the targeting process. In this method, sensors (e.g. tilt sensor or inclinometers), or levelers (e.g. bubble level, plumb level, horizontal levels) can be used to guide a vertical trajectory into the body region any of the component of the insertion assembly including the sheath, the trocar, the handle, the drill guide, or the clot evacuation device.

[00240] After the removal of blood, optionally a new recording of images (e.g. fiducial images) of the hemorrhagic blood and the body region can be obtained to evaluate the completeness of the evacuation, the need for repositioning of the assembly and further blood removal.

[00241] In some methods, imaging algorithms provide guidance, suggestions and additional information to the operator. For example, the algorithm can indicate an entry and target points in at least one reconstruction plane to align the surgical trajectory with the main longitudinal axis of the target lesion. For example, the imaging algorithm can generate 3D volumetric renderings of the ICH based of differential density (e.g. by thresholding method based on the threshold value in Hounsfield Units or HU) to the surrounding brain and identify the longest line that fits into the volume, the line that is surrounded by the largest volume of ICH, or a combination thereof. In CT, brains parenchyma can have around 35-40HU and ICHs have around 50-60HU. As another example, the focal skull thickness can limit the lateral reach of the tubular element in the target tissue. The mean thickness of frontal bone is typically 8±2 mm (frontal and occipital bone) to 4.7+1.3 mm (temporal bone). The creation of an 8mm hole in the frontal bone with a trajectory perpendicular to the skull surface provides an intracranial access cone with an angle of 13+3° when a tube with an outer diameter of 6mm is introduced. In some embodiments, the imaging algorithm can overlay the predicted Intracranial cone of access and recommend entry and target points to optimize coverage of the target lesion (i.e. access the largest amount of ICH volume). As another example, the imaging algorithm can highlight “spot signs” related to active bleeding (by measuring Hounsfield units >90 of iodinated contact actively extravasating) and recommend trajectory to this target. As another example, the imaging algorithm can indicate a trajectory between an entry and target point avoiding vasculature structures.

[00242] In some methods, the multiplanar reconstruction of the body part obtained with the fluoroscopic system (Flat panel fluoroscopy or CT) can be overlayed and/or blended to relevant structural and/or functional anatomy of the same patient, another patient, or to pre-existent datasets or anatomical maps. Images to be fused may derive from multiple sources, including MR, CT, O- Arms, MRA, CTA, PET, fMRI, catheter angiography. For example, in the case of ICH evacuation, relevant anatomy includes: 1) tracts including association fibers (e.g. cingulum, arcuate fasciculus, superior longitudinal fasciculus), commissural fibers and projection fibers (e.g. corticospinal tract); 2) cisterns; 3) fissures (e.g. sylvan fissure and inter-hemispheric fissure); 4) region with high density of perforating arteries (like anterior perforated substance); vascular structures (both arterial and venous). For example, imaging algorithms can use these structural and functional maps along with the shape, size and location of the ICH to guide and/or suggests entry and target point.

[00243] In some methods, more than one flat panel CT can be obtained in the same patient during a procedure to evaluate the remaining ICH volume, the total and percentual reduction, topography of remaining clot.

Assessing with fiducial markers

[00244] In some cases, the spatial alignment element is a fiducial alignment element comprising a proximal fiducial marker at a proximal end of the tubular member of the sheath, the trocar or the drill guider, and a distal fiducial marker at a distal end of the tubular member of the sheath, the trocar or the drill guider.

[00245] In some cases, assessing the alignment comprises:

(a) aligning a fiducial imaging device with the desired trajectory;

(b) recording an alignment fiducial image with the fiducial imaging device that shows the proximal fiducial marker and the distal fiducial marker;

(c) determining the relative angles between the longitudinal axis of the sheath and the desired trajectory based on the appearances of the proximal fiducial marker and the distal fiducial marker in the alignment fiducial image.

[00246] The fiducial markers can be fluoroscopic markers, wherein the fiducial imaging device is a fluoroscopic imaging device. For example, the markers can be X-ray markers and the device can be an X-ray imaging device or fluoroscopic images. The method can also use magnetic markers and an MRI imaging device.

[00247] In some cases, the cross sections of the fiducial markers have the properties and shapes discussed above regarding the sheath fiducial markers. The cross-sections of the fiducial markers are cross-sections that exist in a transverse plane that is perpendicular to the longitudinal axis. For instance, they can have cross sections that form concentric rings and do not overlap with each other when viewed along the longitudinal axis.

[00248] The relative appearance of these FMs in the image can be used to determine the relative angle of the sheath. For example, FIG. 7 shows embodiments of FMs that can be used for this purpose. The left column shows a side view of the sheaths and their fiducial markers. The right column shows a side view of the fiducial markers and how they would appear if the depth imager was recorded at a perpendicular angle. The middle column shows how the markers would appear on an alignment X-ray image if the sheath was perfectly aligned with the X-ray imager. For example, the top embodiment shows a single circle because the two FMs are concentric and have the same diameter. In contrast, the next embodiment shows two concentric circles because the FMs are concentric but have different diameters or there is sufficient distance between the markers to have substantially different sizes in the flat panel detector. The next embodiment shows a closed-circle within an open circle because the distal FM is a closed circle. The next embodiment shows a circle with two perpendicular lines. If the perpendicular lines extended beyond the circle, then the sheath is misaligned with the X-ray imager. The bottom embodiment shows a circle because the markers are concentric.

[00249] In some embodiments, there is a proximal FM that has a substantial length in the longitudinal direction. This FM is dimensioned such that proper alignment will give a first appearance but misalignment will give a second appearance. Stated in another manner, proper alignment will only show the top of the proximal FM whereas misalignment will show both the top and a side surface of the FM, which will have a different appearance. The bottom embodiment of FIG. 7 shows such a proximal FM. For example, the FM can have a length along the longitudinal axis that is at least 200% of its width. For example, the FM can have a length that is 50% or more of the length of the sheath along the longitudinal axis.

[00250] In some cases, the method of providing fluoroscopic stereotactic guidance is by:

(a) selecting a superficial entry point and a deep target point in multiplanar (axial, coronal and sagittal) tomograph images

(b) aligning the central xray beam of the fluoroscopic imager to intersect the pre-selected entry point and the target points.

(c) recording an alignment fiducial image in X-Y plane that shows the proximal fiducial marker and the distal fiducial marker;

(d) moving the insertion assembly forward, back, right, left, up and down to substantially colocalize the distal fluoromarker with the entry point. (e) determining the relative position and angles between the longitudinal axis of the insertion assembly and the desired trajectory based on the fluoroscopic appearances of the proximal fiducial marker and the distal fiducial marker in the X-Y planar alignment fiducial image.

(f) rolling and pitching the insertion assembly until the fluoroscopic appearance of the fiducial markers indicates alignment of the insertion assembly with the central x-ray beam of the fluoroscopic imager in the X-Y planes.

[00251] In some cases, the relative position between the insertion assembly and the target is temporarily locked by actuating the locking mechanism of the drill guider. In some methods, the drill guider can be used to create burrholes though the skull with the same trajectory than the insertion assembly. This is beneficial to increase accuracy of frameless fluoroscopic stereotaxis when the path through the bone is not perpendicular and when the burr hole size matches the size of the insertion assembly.

[00252] In some embodiments, imaging fiducial markers can be applied to the surface of the body part, head holder or operating table. Fiducial markers can facilitate the selection of entry point in the body surface, and can be used at any point during the intervention to help detecting and correcting for unwanted motion of the body part. For example, this method can detect and quantify the relative motion of fiducial markers during fluoroscopy compared to the baseline image, and automatically or semi-automatically make corresponding changes to the previously set entry point and target points. This would be beneficial to increase the accuracy of the stereotaxis method. In some methods, body parts with sufficient radiodensity such as part of the skeleton can act as fiducial markers.

Assessing with laser lights

[00253] Assessing the alignment can include calibration with laser lights.

[00254] In some cases, the spatial alignment element is a laser alignment element. This laser alignment element can be positioned at the proximal end of the tubular member of the sheath, the trocar or the drill guider. For example, the assessing of the alignment can include the steps of:

(a) emitting two perpendicular laser lights from laser light alignment sources in the X axis and Y axis that result in a crosshair in the Z axis that follows a trajectory that intersects the pre-selected entry point and a target point.

(b) positioning the distal end of the insertion assembly at the laser crosshair projecting at the body surface which substantially corresponds to the preset entry point.

(c) determining the relative angles between the longitudinal axis of the insertion assembly and the desired trajectory by evaluating the lasers projection on the laser light alignment element. (d) adjusting the spatial orientation of the insertion assembly until its longitudinal axis is aligned with the trajectory between the entry point and the target point.

In some cases, the laser light alignment element comprises a pillar extending proximally along the longitudinal axis, wherein the evaluating comprises evaluating if the pillar blocks laser light from contacting a section of the outer surface of the proximal end, wherein such blocking indicates that the pillar creates a shadow and the longitudinal axis is not aligned with the desired trajectory.

[00255] In some cases, the outer surface of the proximal end comprises two or more alignment markings that correspond to the transverse distance between the center of the pillar and the alignment markings.

[00256] In some cases, the two or more alignment markings are concentric rings that are also concentric with the pillar.

Depth of insertion

[00257] In some cases, after aligning the trajectory in the X-Y planes, the fluoroscopic imager is positioned substantially perpendicular and used to visualize the depth of advancement of the insertion assembly in a Z plane.

[00258] In some case, the tubular member of the sheath comprises depth indications on an external surface of the middle wall that extend along the longitudinal axis from the distal end, wherein inserting the insertion assembly into the body region to the desired depth comprises:

(a) determining a target depth indication that corresponds to the desired depth; and

(b) inserting the insertion assembly until the target depth indication is at the external surface of the body region.

[00259] For example, FIG. 8 shows a tubular member with depth indications along its external surface. Also, FIG. 13 shows a tubular member with depth indications.

[00260] In some cases, inserting the tubular member into the body region to a desired depth comprises:

(a) moving the distal end of the tubular member a first distance into the body region;

(b) capturing a first depth fiducial image of the distal fiducial marker from an angle that is at least 10° away from the desired trajectory;

(c) determining the location of the distal end of the sheath in relation to the destination site from the captured first depth fiducial image;

(d) if the distal end was determined to be outside the destination site, repeating the moving, capturing, and determining by:

(i) moving the distal end of the sheath to a new depth inside the body region; (ii) capturing a new depth fiducial image of the distal fiducial marker from an angle that is from 10° away to 90° away from the desired trajectory;

(iii) determining the new location of the distal end of the catheter in relation to the destination site from the captured new depth fluoroscopic image; wherein the repeating can be performed one or more times.

[00261] For example, FIG. 6 shows a sheath being inserted into the brain of a subject. The top panel shows the recording of the alignment X-ray images in the x-y plane to determine proper alignment. Afterwards, X-ray images in the z plane are recorded to determine how deep the sheath has been inserted. In some cases, the first depth fluoroscopic image is captured from an angle that is from 40° away to 90° away the desired trajectory.

[00262] In some cases, the first depth fiducial image is captured from an angle that is from 40° away to 90° away the desired trajectory.

Removal of blood

[00263] In some cases, removal of the hemorrhagic blood comprises applying suction through the lumen of the tubular member.

[00264] In some embodiments, the removal of the hemorrhagic blood comprises: inserting the distal end of the barrel of a blood removal device as described herein into the sheath; and activating the activator of suction of the blood removal device, thereby causing suction to move the hemorrhagic blood into the barrel of the blood removal device.

[00265] In some cases, removal of the hemorrhagic blood further comprises activating the electrocoagulation element of the blood removal device and thereby coagulating blood, stopping the bleeding of a blood vessel, or a combination thereof at the destination site.

[00266] In some cases, the removal step further includes observing the destination site through the visual display, i.e. wherein the visual display shows the images recorded from the camera at the distal end of the barrel of the device.

[00267] In some cases, removal of the hemorrhagic blood further comprises activating the cutting element to cut material at the destination site and then removing the cut material through the suction channel.

[00268] In some instances, the cut material is coagulated blood.

[00269] In some cases, it can be difficult to removal all of the solid material from the destination site with the suction. Thus, in some cases, removal of the hemorrhagic blood further comprises activating the activator of irrigation of the blood removal device, thereby causing irrigation liquid to move through the irrigation channel and into the destination site. As such, the solid material particles can be suspended in the liquid, thereby making them easier to remove with suction. The irrigation liquid can also help clean the destination site.

[00270] In some cases, the removing of at least some of the hemorrhagic blood through the catheter is performed within 120 minutes or less of the recording of the initial fiducial. In some embodiments, this performance is within 90 minutes or less, 60 minutes or less, 45 minutes or less, or 30 minutes or less. The method allows for a simplified workflow that can be performed in less time, wherein it is very desirable to address the medical need as soon as possible for the health of the patient.

Other aspects of the method

[00271] In some cases, the method further includes:

(a) moving a camera through the sheath and to the distal end of the catheter;

(b) visually observing the destination site with the camera.

[00272] For example, the camera can be a part of the blood removal device discussed above.

[00273] In some cases, the body region is the patient’s head and the hemorrhagic blood is located in the patient’ s brain.

[00274] In some instances, the acquisition of fiducial image, target and trajectory selection and insertion is performed in an Angio Suite. In these cases, the removal of at least some of the hemorrhagic blood through the sheath is performed within 60 minutes or less of the recording of the initial fiducial images. In some cases, the 120 minutes or less is 45 minutes or less. In other words, the present method can provide a technical advantage of quickly removing the blood in a short amount of time. It is medically risky for the patient to have the blood present in the body region for long regions of time, especially if the blood is present in the brain, e.g. because it can cause pressure that damages brain tissue. In addition, endovascular procedures to diagnose and embolize bleeding lesions performed in the same interventional radiology suite is advantageous to expedite hemostasis and prevent further hemorrhage. Finally, after the removal of blood, optionally a new recording of fiducial images of the hemorrhagic blood and the body region can be obtained to evaluate the completeness of the evacuation, the need for repositioning of the assembly and further blood removal.

[00275] In some cases, the method is performed by an interventional radiologist or interventional neurologist familiar. In other words, it is not necessary for a traditional neurosurgeon to perform the method. Since a traditional surgeon is not always available when the patient enters a hospital, the present method has the advantage that it can be performed by other types of medical professionals.

[00276] In some cases, the alignments are performed with an X-ray beam that is the central X- ray beam of a X-ray projection of beams. EXAMPLES

[00277] The following examples are put forth so as to provide those of ordinary skill in the art with a complete disclosure and description of how to make and use the present invention, and are not intended to limit the scope of what the inventors regard as their invention nor are they intended to represent that the experiments below are all or the only experiments performed. Efforts have been made to ensure accuracy with respect to numbers used (e.g. amounts, temperature, etc.) but some experimental errors and deviations should be accounted for.

Example 1

[00278] FIG. 1 shows an axial cut of a brain with a left intracerebral hemorrhage in a noncontrasted head CT, along with a schematic diagram of the brain that notes the area of hemorrhage. [00279] FIG. 2 shows three different tomographic planes of a brain with hemorrhagic blood as the dark gray region. The surgeon has selected an entry site along with a target site within the region of hemorrhagic blood. The dashed lines shows the desired trajectory between the two sites. [00280] FIG. 3 shows a setup for performing the method of removing the hemorrhagic blood by employing cartesian coordinates with fluoroscopy. At the top-center is the first X-ray imager that is aligned in the x-y plane, i.e. that is aligned with the desired trajectory from the entry point to the target site. On the opposite side of the patient is the X-ray detector. The central ray emitted from the X-ray source is also shown. FIG. 3 also shows the location of a second X-ray imager that shoots X-rays from the back-top of the patient’ s head towards their mouth. This second X- ray setup allows for an assessment of the depth of the sheath when inserted. The second X-ray imager is oriented at roughly 90° from the first X-ray imager. The two X-ray imagers can actually be single X-ray imaging device this is simply moved between two locations during the two steps of the procedure. The position of the X-ray detector and the x-ray source can be flipped.

[00281] FIG. 4 shows the three dimensions of spatial movement on the X, Y and Z axes as well as the change in orientation between those axes called pitch, yaw and roll. These 6 axes can be modified and track with live imaging including fluoroscopy for a 7th degree of freedom as a function of time. FIG. 4 also shows the relationship between the X-ray imager, the brain, the head, and the hemorrhage region.

[00282] The top panel of FIG. 5 shows a first alignment X-ray image within the X and the Y axes. The bottom panel shows a depth X-ray image in the “y-z plane” (or Z axis) that shows the depth between the entry point and target point.

[00283] FIG. 6 shows the use of two fiducial markers that can be used in a sheath for fluoroscopic targeting in a three-dimensional cartesian coordinate system. The top left panel shows an x-ray machine with the central beam crossing two fluoromarkers of device and following the longitudinal axis of an intracranial target. The top right panel shows an X-ray image with concentric rings of the two fluoromarkers over the intracranial target in the X-Y axis. The proximal A-ring has a smaller circular cross section whereas the distal B-ring has a larger circular cross section. The image shows that the two markers are concentric and have the same center point, thereby showing that the sheath’s longitudinal axis is aligned with the X-ray imager device. If the two rings were not concentric, then this would indicate that the sheath is tilted and not aligned with the X-ray imager. The X-ray imager is aligned with the target trajectory. The bottom left panel shows an x-ray machine projecting the central x-ray beam overall perpendicular to the longitudinal axis of the intracranial target. The bottom right panel shows an X-ray image in a Z- axis demonstrating the entry point and target point of the intracranial target.

[00284] FIG. 6 shows an example of two fiducial markers that can be used on a sheath. In particular, both markers are open circles. The proximal A-ring has a smaller circular cross section whereas the distal B-ring has a larger circular cross section. The image shows that the two markers are concentric and have the same center point, thereby showing that the sheath’s longitudinal axis is aligned with the X-ray imager device. If the two rings were not concentric, then this would indicate that the sheath is tilted and not aligned with the X-ray imager. The X-ray imager is aligned with the target trajectory.

[00285] FIG. 7 shows additional embodiments of possible fiducial markers (FMs). The left column shows a side view of the sheaths and their fiducial markers. The right column shows a side view of the fiducial markers and how they would appear if the depth imager was recorded at a perpendicular angle. The middle column shows how the markers would appear on an alignment X-ray image if the sheath was perfectly aligned with the X-ray imager. For example, the top embodiment shows a single circle because the two FMs are concentric and have the same diameter. In contrast, the next embodiment shows two concentric circles because the FMs are concentric but have different diameters. The next embodiment shows a closed-circle within an open circle because the distal FM is a closed circle. The next embodiment shows a circle with two perpendicular lines. If the perpendicular lines extended beyond the circle, then the sheath is misaligned with the X-ray imager. The bottom embodiment shows a circle because the markers are concentric.

[00286] FIG. 8 shows a sheath that further comprises a handle. The handle can make it easier for a surgeon to hold and move the sheath in a correct orientation. The handle can allow the surgeon to move the sheath without irradiation during fluoroscopy. In some embodiment, the handle can be part of the trocar. The FIG. 8 embodiment also includes depth markings, wherein the depth is determined by observing the number located at the entry site to the patient’s body.

[00287] FIG. 9C shows a navigation stylet. The navigation stylet can be introduced or mechanically coupled to the sheath or trocar for navigation. The navigation stylet has multiple navigation elements that can be used to help with orientation by coordinating with a surgical navigation device. For example, Azarmehr et al. (Journal of Oral and Maxillofacial Surgery, 2017, 75, 9, 1987, doi: 10.1016/j.joms.2017.01.004) and Waelkens et al. (“Surgical Navigation: An Overview of the State-of-the-Art Clinical Applications”, within the book “Radioguided Surgery”) are reviews of surgical navigation systems and methods.

[00288] FIG. 10 shows a device for removing the hemorrhagic blood after reaching the destination site. For example, first, the sheath can be properly oriented along the desired trajectory at the entry site. Afterwards, the sheath can be inserted to the desired depth such that it reaches the hemorrhagic blood. Next, the barrel of the FIG. 10 device can be inserted into the lumen of the sheath until the distal end of the barrel reaches the distal end of the sheath and the hemorrhagic blood destination site.

[00289] The FIG. 10 clot evacuation device includes a suction trigger that allows suction through negative air pressure, thereby helping to remove blood from the site. The device also includes an irrigation trigger that causes saline solution or other fluid to be inserted into the site, and afterwards the fluid and other debris can be removed with suction. The device also includes a cutting element located inside the suction channel at its distal end. Activation of the cutting element causes the cutting element to move and cut clots or other bodily tissue, thereby allowing them to be removed through suction. The device also includes a light source and a camera positioned at the distal end of the barrel. The device includes a visual display connected to the camera. Hence, the surgeon can visually observe the site with hemorrhagic blood, thereby allowing an assessment of the site. For instance, the camera can show how much of the blood has been removed and whether blood vessels are still bleeding.

[00290] The barrel of the clot evacuation device in FIG. 10 has an angled distal end (bevel), i.e. wherein the bottom side of the distal end extends further in the distal direction than the top of side of the distal end. The angle in the FIG. 10 device is approximately 45°. In some embodiments, the light source and camera are located on the top side of the distal end, and therefore the light source and camera are located behind the most distal portion of the barrel. As such, the camera can be oriented in the forward direction also observe each of the objects that are approaching the entrance of the suction channel. This ability to be oriented forward and also observe the entrance to the suction channel represents a technical advantage. A forward-oriented camera located at the most distal part of the barrel could not observe objects as they entered the suction channel. In other embodiments, the light emitter and camera are located on the bottom side of the distal end. The camera can observe objects that are approaching the entrance to the suction channel and inside the barrel if the latter is made of transparent materials. In some embodiments, the top side of the distal end extends further in the distal direction than the bottom of side of the distal end. [00291] The FIG. 10 clot evacuation device also includes a handle that is shaped so that it can be steadily and easily held by a surgeon. The FIG. 10 device has an irrigation line, a suction line, and an RF cord that exit the bottom side of the handle. The device also includes a port for receiving an SD (Secure Digital) card, which can be used to receive electronic files with images and video of the procedure after the procedure has been completed. This SD card port is one embodiment of an image export element, which could also be a USB port.

[00292] In some embodiments, the clot evacuation device is connected to an image control box. The image control box has the needed hardware and software to enable and support the performance and recording of the procedure, for example control of images (light intensity, zoom, white balance, orientation, etc), record of data including images and videos, transfer video to accessory video display, provide power to the clot evacuation device.

[00293] As discussed above, the FIG. 10 clot evacuation device includes an irrigation trigger, a suction trigger, and a cutting element trigger, which can also be called a “clot cutter trigger”. The device includes a trigger guard includes two perpendicularly oriented members. This trigger guard helps prevent accidental activation of the triggers. Additionally, the three triggers are positioned within the same plane, with the irrigation trigger located forward, the suction trigger located next, and the clot cutter trigger located in the back. Thus, this orientation allows a surgeon to pull on the irrigation trigger, starting irrigation, and then continue pulling to also activate suction. Hence, two different functions can activated simultaneously with a single motion with a single finger. Similarly, the surgeon could activate the suction and clot cutter triggers simultaneously with a single finger motion. In fact, the surgeon could activate all three triggers simultaneously with a single finger motion. This consolidation makes the procedure easier for the surgeon by freeing the other nine fingers to perform other important functions, such as holding the handle, holding the barrel, or manipulating other devices. This consolidation of function also makes the procedure mentally easier for the surgeon, giving the surgeon more mental space to concentrate on other important aspects of the procedure. In some embodiments, one trigger for irrigation is actuated by the thumb, while another trigger is actuated by the index finger and has a double function of providing vacuum and then actuating the clot cutter when fully pulled.

[00294] FIG. 11 shows a cross-sectional view of the barrel of the FIG. 10 clot evacuation device near the distal end. The top section has the camera (for example a wafer-level camera module with image sensor, processor and lenses), the irrigation channel, and the light (for example light emitting diode). The suction channel occupies the middle and bottom regions of the cross-section. Also shown are the exterior walls of the barrel. In the embodiment represented in FIG. 1 1 , the irrigation channels are built in the sheath, and these form a rail for the barrel of the clot evacuation device. In other embodiments, the irrigation channels are built in the barrel of the clot evacuation device enabling barrel rotation relative to the sheath. In some embodiments, more elements are in the barrel of the clot evacuator device, such as pull/push wires to actuate clot cutting mechanism and electrical wires to deliver radiofrequency energy to electrodes disposed at the distal end of the barrel for electrosurgery. In some embodiments, the irrigation channel and the suction channel have one or more connections in the most distal 10mm to 30mm to enable fluid movement and facilitate transport of clots.

[00295] FIG. 12 shows the FIG. 10 device connected to auxiliary elements. The device is connected to an irrigation solution reservoir (typically pressurized), a vacuum source, and an electrosurgical generator device. Although not shown visually in FIG. 10, the device can have an electrical element at the distal end of the suction channel that becomes electrified by the electrosurgical generator, e.g. to electro-coagulate blood or to close blood vessels through electrical ways. FIG. 12 shows that the electrosurgical generator can be activated by a foot switch. Although not shown visually in FIG. 10, the device can also have connection to more elements such as a control box for clot evacuator device power, transfer videos to display monitor, transfer data to a storage unit, digitally adjust image quality, brightness, focus, orientation, etc.

[00296] FIG. 13 shows a sheath with depth markings and a handle. The figure also shows the barrel of the FIG. 10 device being inserted into the lumen of the sheath.

[00297] FIG. 14 shows options for electrodes that can be located at the distal end of the barrel of the device. The top embodiment shows the electrodes located at the bottom, forward end of the barrel. The middle embodiment shows the electrodes protruding forward ahead of the most distal end of the barrel. Bottom embodiment shows the electrodes located on the side walls of the distal end of the barrel.

[00298] FIG. 14B shows an example of how electrodes can be used to cut, coagulated and shrink blood clots so that it can be removed by suction into the suction channel.

[00299] FIG. 15A shows a cross-section representation of the surface of the head. Previously, a cut was made in the skin and then a bone window in the skull bone, exposing the dura that is located between the skull bone and the brain. The electrodes located at the distal end of the device can be used to coagulate blood at the dura layer.

[00300] FIG. 15B shows the distal end of the device being inserted past the dura and making contact with the brain to coagulate its surface.

[00301] FIG. 15C shows the distal end reaching the hematoma and blood. Four sections of the coagulated blood have been detached and are being removed by suction.

[00302] FIG. 15D shows how suction has caused the bleeding blood vessel to be pulled into the suction channel of the barrel. [00303] FIG. 16A shows and embodiment of a cutting element as a loop wire hinging in the lumen of the barrel configured to cut a section of clot. Specifically, a half-circle element is rotated about 180°, thereby cutting a section of the clot.

[00304] FIG. 16B shows additional embodiments of clot cutters, i.e. cutting elements. For example, a wire can extend along top side of the barrel towards distal end. At the top side of the distal end, the wire can become a loop. To cut the clot, the wire can be pushed forward, thereby causing the loop to move from the top side to the bottom side, thereby cutting the blood clot in its path. This embodiment can be referred to as a “lasso” clot cutting element. In some embodiments, the lasso wire can be made of a hyperelastic material and pre-set to form a shape when deployed substantially similar to the lumen of the barrel. Some embodiments include one or more structural elements (e.g., rails, guards, slots, recesses, and fins) to increase the element stiffness, minimize unwanted rotation, and maintain the orientation during movement in the barrel lumen. In some embodiment, the subcomponents, including the barrel and sheath can have a railing system along at least a portion of the length with one of the following cross-sectional shapes: circular, oval, square, start, diamond, rectangular, flat, or a combination thereof. The receiving lumen conforms to the shape of the inner member including the lasso wire. For example, the wire and the lumen where it travels can have flat shapes to restrict unwanted rotational motion during longitudinal displacement (for actuation of the lasso). The receiving lumen ID approximately matches (e.g., within 10 thou) the OD of the inner member to restrict non-longitudinal motion or is shaped to allow a limited preset range of rotational motion. In some embodiments, the subcomponents include one or more rail systems per subcomponent, and the rail system can include the full subcomponent length.

[00305] Non-circular configurations of the lasso wire (or other clot cutting elements including the tongue) can limit the relative rotation between subcomponents while maintaining the capacity to telescope along the longitudinal axis (e.g., longitudinally). Such non-circular embodiments help to maintain the trajectory of the cutting element in the lumen of the barrel. In other embodiments, radial alignment between telescoping elements can be maintained by coupling longitudinal recesses and fins at the interfacing surfaces. The longitudinal movement of the lasso wire (or other clot cutting mechanism) can be power by hand or by a drive system.

[00306] FIG. 17 shows an embodiment of a clot cutter. The distal end of the wire is formed into a paddle or “tongue” shape. Pushing the clot cutter forward causes the tongue to move from the top side to the bottom side, cutting the clot in a guillotine manner. In some embodiments, the tongue can be made of a hyperelastic material, have a distal shape substantially similar to the distal opening of the lumen of the barrel, and pre-set to advance obliquely into the barrel lumen. In some embodiments, the flat tongue is configured to have a curvature matching the inner lumen of the barrel. At rest, the tongue is apposed to or within the wall of the barrel. When actuated by advancement relative to the barrel, the tongue shape changes to substantially match the lumen of the barrel. In some embodiments, the structural elements herein described (e.g., rails, guards, slots, recesses, and fins) are configured to increase the element stiffness, minimize unwanted rotation, and maintain the orientation during movement in the barrel lumen. In some embodiments, the tongue can completely occlude the lumen of the barrel or distal opening when fully advanced. In other embodiments, the tongue occludes the lumen of the barrel incompletely to maintain suction during actuation, for example by the presence of holes in the tongue.

[00307] FIG. 18A shows to more embodiments of clot cutters. The left embodiment is a “brush” embodiment where the element can be moved outwards and then inwards. The perpendicular “fins” pull some clot into the suction channel, thereby cutting it. The right embodiment has a element that extends down the center of the suction channel but then moves towards an outside wall at the distal end. Rotating the element causes it to cut the clot.

[00308] FIG. 18B shows a clot cutter with a rotating circular member (left) and a rotating spiral element which is similar to the Archimedes’ screw (right).

[00309] FIG. 18C shows another rotating clot cutter with an element in the shape of a circle that has been bent into a parabolic shape.

[00310] FIG. 19A shows one embodiment where irrigation and suction are used. The distal end has an angled end, that can also be referred to as a “beveled” end. Fluid can be delivered to form one or more jets with sufficient pressure and flow to cut clots and facilitate clot ingestion. Fluid jets can be directed into the barrel lumen, at the front end of the barrel, around the barrel or a combination.

[00311] FIG. 19B shows an embodiment of a beveled end with irrigation, suction, and electrodes on side walls of the barrel.

[00312] FIG. 20 shows the cutting of a clot with electrodes, followed by suction.

[00313] FIG. 21 shows the movement of lasso wires with a built-in electrode and their spatial relationship to an electrosurgical electrode on the opposite side of the barrel of the clot evacuation device. In this embodiment, the radius of curvature of the lasso is substantially similar to the radius of curvature of the barrel opening, resulting in a substantially equivalent distance between the moving electrode (in the lasso) and the fix electrode (in the barrel wall). This facilitates electrocoagulation of bleeding arteries by optimizing the radiofrequency field lines. The arc length of the electrodes is typically 30 to 120 degrees of the lasso and barrel opening.

[00314] FIG. 22 shows a bleeding artery being sucked into the vacuum channel. Also, a bipolar electrode is used to electro-coagulate the artery and obtain hemostasis. The artery is surrounded by a hematoma. [00315] FIG. 23 shows a tongue actuated by push wire with a front-end electrode that moves downwards towards another electrode at the opening of the barrel. In the top panel, vacuum pulls inwards the bleeding structure. In the bottom panel, the descending tongue pushes the bleeding vessel downwards which eventually is compresses with the barrel electrode, followed by delivery of electrosurgical energy for coagulation and hemostasis. Vascular compression following by bipolar electrocoagulation is highly effective in achieving hemostasis.

[00316] FIG.24 shows a method to evacuate an intracerebral hematoma with frameless fluoroscopic navigation and the clot MINE device. FIG. 24 A shows (1) trajectory alignment of central x-ray beam with entry and target points with fluoroscopic flat panel visualization, and (2) skin incision, burrhole creation in skull, dura coagulation with clot MINE bipolar electrode.

[00317] FIG. 24B shows (3) dura opening and coagulation and (4) advancement of sheath and trocar into brain with X-ray guidance.

[00318] FIG. 24C shows (5) removal of trocar from sheath and introduction of clot MINE into sheath and (6) ingestion of clot. In typical situations, the clot enters the sheath and this is ingested by the clot MINE device. The clot MINE device can be advanced into the clot and beyond the sheath as needed.

[00319] FIG. 24D shows (7) cavity inspection with scope and irrigation and (8) coagulation of the bleeding vessel.

[00320] FIG. 25 shows another embodiment of the device formed by a tubular structure entering the brain. FIG. 25A shows a device with handle, seal, RF cord, suction cord, irrigation, sheath, a RF ring electrode built in the sheath wall, and a lumen. In this embodiment, the vacuum is provided by the suction cord to the sheath, resulting in clot ingestion directly into the sheath.

[00321] FIG. 25B shows a clot MINE device with a scope and light and an RF electrode mounted over a movable tongue.

[00322] FIG. 25C shows motion of tongue based on pulling the trigger of the FIG. 25B device. [00323] FIG. 26 shows the clot MINE device inside the sheath, and the sheath inserted inside the brain and into a clot. Vacuum is applied to the sheath resulting in clot ingestion and inward displacement of a bleeding artery. Actuation of the trigger result in movement of the tongue into the lumen and towards the ring electrode, facilitating bipolar electrocoagulation.

[00324] FIG. 27A shows a guider device with a guider body, guider handle, and fluoroscopic markers.

[00325] FIG. 27B shows the FIG. 27 A guider device along with a drill for drilling through the bone, the body of the patient, and how the fluorogenic markers appear on the x-y plane imager. The 3D orientation of the guider was provided aligning the fluoromarkers along a central x-ray beam bisecting the pre-selected entry and target points. Example 2

[00326] As discussed above, FIG. 8 shows a tubular member with depth indications along its external surface and FIG. 13 also shows a tubular member with depth indications. In some cases, the depth indications include Arabic numerals, e.g. that include indications at 1 cm intervals or 1 inch intervals. The Arabic numerals can be oriented perpendicularly to the longitudinal axis, e.g. as shown in FIG. 8. The Arabic numerals can also be oriented parallel to the longitudinal axis. In some cases, the middle wall of the sheath has a length of 140 mm or more. In some cases, the lumen has a diameter of 6 mm or less, i.e. the middle wall has an inner diameter of 6 mm or less. In some cases, the middle wall has an outer diameter of 7 mm or more.

[00327] FIGS. 43A-B shows two views of the distal end of the insertion assembly formed by a trocar inside a sheath (top figure is a side view, lower figure is a translucid side view). The trocar has a conical tip 4301 with an angle of 30 degrees with the center line, a length of 6.2 mm and a proximal outer diameter of 4.25 mm. The surface of the cone transitions to the surrounding sheath with a chamfer 4302 with 80 degrees with the vertical resulting in tapered, edgeless transition. The edgeless conical shape of the combination of the trocar and the sheath minimizes tissue resistance resulting in a low-friction, non-dragging advancement through brain tissue, which is pushed outwards rather than cut contributing to the safety and efficacy. This geometry also minimizes the likelihood of vascular perforation and avulsion by unwanted traction.

[00328] In some cases, the trocar can have a beveled distal edge, as shown . A first bevel can have an angle between 10° and 89° relative to the longitudinal axis. The first bevel can have a length of between 0.5 mm and 5 mm along the longitudinal axis. The second bevel can have an angle of between 30° and 50° relative to the longitudinal axis. The second bevel is located at the distal end of the trocar, whereas the first bevel is located proximally to the first bevel in FIG. 43. [00329] FIG. 44 A shows a trocar with beveled distal end 4401, proximal end 4402, a tridimensional dome shaped laser alignment element 4403 located at proximal end 4402, and handle 4404. Handle 4404 is oriented perpendicularly to the longitudinal axis formed between proximal end 4401 and distal end 4402. Additionally, handle 4404 is attached to the main section of the trocar near proximal end 4402. Laser alignment element 4403 has groove shown in FIG. 44A, but can also have lines or ridges. The handle length can be 100 mm to 120 mm in some cases.

[00330] FIG. 44B shows an alternate view of the FIG. 44A trocar that looks down the longitudinal axis from distal end 4401 to proximal end 4402. FIG. 44B shows four grooves that are part of the laser alignment element. Also shown are distal fiducial marker with a cone shape 4405 which is located at the distal end, and proximal fiducial marker 4406 located as a ring just before the handle.

[00331] FIG. 44C shows crossing orientation grooves of the tridimensional laser alignment element shaped as a dome when viewed from the opposite direction as FIG. 44B.

[00332] FIG. 45A shows a tubular member with a ball joint that can function as a piece of the drill guide. In some cases the inner diameter is 9 mm or less and the outer diameter is 11 mm or more. The ball joint can be smooth or textured, e.g. a textured surface (e.g. a knurled surface) can enhance friction and thereby secure the drill guide in a particular orientation within the base. In some cases the drill guide is partially, or full, a biocompatible material, such as acrylonitrile butadiene styrene (ABS) or poly etheretherketone (PEEK).

[00333] FIG. 45B shows that fiducial markers 4501 and 4502 can be located near opposite ends of the drill guide.

[00334] FIG. 45C shows the drill guide positioned within a base, thereby permitting the ball joint to rotate within the base, e.g. by at least 60°.

[00335] FIG. 45D shows a top view of the drill base. The drill base can have a largest horizontal dimension (e.g. a width) ranging from 20 mm to 55 mm, which can accommodate various anatomical structures. The central aperture can have an inner diameter of 11 mm or less. The vertical thickness of the drill base can range from 0.5 mm to 5 mm, thereby providing sufficient rigidity. The holes in the base can accommodate screws and can be 0.5 mm to 3 mm in diameter. The hole for accommodating the screw in FIG. 45D also has a joined second hole that can accommodate a shock absorbing or vibration dampening material, such as medical grade rubber or an elastomeric insert. These inserts can fit around the screw, preventing loosening or backing out. By dampening vibrations the inserts can help to absorb and dissipate vibrations incurred during drilling, thereby minimizing stress on the surrounding bone. The drill base material can include rigid biocompatible polymers (e.g. ABS or PEEK), stainless steel (e.g. 316L), titanium, or a titanium alloy.

[00336] FIG. 45E shows a clean horizontal view and an annotated horizontal view of the base. The bottom surface of the base has a slight curvature, e.g. to accommodate the surface of the patient’s body, such as the curvature of the skull. In FIG. 45E the curvature is 5°. In other embodiments the curvature can be 1° to 15°.

[00337] FIG. 45F shows different views of a twist knob for securing the tubular member to the base. The twist knob can be cylindrical or disc shaped, as in FIG. 45F. The locking surface is the inside of the twist knob and can have an inner diameter of 20 mm to 30 mm. The outer surface can have a textured surface to increase grip, such as a knurling pattern (e.g. diamond, straight, or diagonal). The textured surface can include ridges, grooves, or dimples. The outer diameter can range from 30 mm to 55 mm, thereby providing a comfortable grip for most users. The height of the twist knob can be 5 mm to 20 mm. Exemplary materials of construction include ABS, PEEK, polycarbonate, stainless steel (e.g. 316L), aluminum, titanium, a biocompatible materials, fibers (e.g. glass or carbon fiber), or a combination thereof.

[00338] FIG. 46A shows a wire frame drawing of a blood removal device. The device includes barrel 4601, distal end of barrel 4602, proximal end of barrel 4603, handle 4604, trigger 4605, irrigation button 4606, and connections 4607. The trigger is a dual-action trigger that activates a first function when depressed to a first depth and activates a second function when depressed to a second, greater depth. The irrigation button can activate a third function. For example, the trigger can activate suction and then the cutting element, or the cutting element and then suction. In some cases, the irrigation button can activate the irrigation. Connections 4607 include one or more tubes that connect to suction and irrigation, i.e. for irrigation with water or a saline solution. Connections 4607 can also include a wire for digitally connecting a camera located at distal end 4602 to a computer, e.g. so that the pictures or video from the camera can be sent to the computer. The wire can be a metal wire, e.g. for traditional electronic communications, or a fiber optic wire for fiber optic communications. Connections 4607 can also include a power cable for supplying power to the camera, the cutting element, or both. The power cable can supply power at 120 volts and 60 Hz. The cutting element can be located at distal end 4602 and can include a cautery tip, e.g. wherein one end of the electrical circuit is attached to the distal end of the barrel and the other end is attached to a tongue element that can move within the barrel. Handle 4604 can be dimensioned for comfortable and secure holding by a single hand of a human user.

[00339] FIG. 46B shows different configuration of the cross section of barrel 4601 of FIG. 46A near the distal end. In this example, the barrel has an outer diameter of 6mm. This cross section includes main lumen 4615, which can be circular or shaped like the letter D. Suction can be provided through main lumen 4615. Main lumen 4615 can have an inner largest dimension of 4.5 mm or more, and in some cases the inner largest dimension is a diameter. The cross section of the entire barrel can be 5.7 mm or more. The camera 4618 and light source 4619 and any attached wires can be positioned within camera lumen 4610, and camera lumen can have a dimension ranging from 1.0 mm to 2.5mm. As shown in the first panel of Figure 46B, the light source 4619 can be positioned on each side of the camera 4618, which elevates the roof of the main lumen 4620 and expands the main lumen 4615. In other embodiments like the second panel of Figure 46B, the light source 4619 can be position between the camera 4618 and the roof of the main lumen 4620. This change results in larger irrigation channels 4611 and 4617 and a more favorable camara 4618 position to drop the horizon and expand the functional visual field. The functional visual field is the image not compromised by the roof of the main lumen 4620 when the camera 4618 is located in the camara lumen 4610. The functional visual field is expanded by decreasing the distance along the main longitudinal axis between the camera and the tip of the barrel, by increasing the separation between the camara 4618 and roof of the main lumen 4620, or by narrowing the roof of the main lumen in front of the camera. Other options include modifying the tilt of the camara, increasing the aperture of the camera, or using cameras with angled view. [00340] Irrigation can be provided through irrigation lumen 4611 and 4617, which can have a radius of 0.75 mm to 2 mm. In an alternative embodiment, the camera lumen 4610 and the irrigation lumens 4617 may be separated by an inclined wall to maximize the cross-sectional area of the irrigation lumens. Said inclined wall may have a thickness ranging from 0.10 mm to 0.50 mm. In another embodiment, the walls separating the camera lumen 4610 and irrigation lumens 4617 may be removed, resulting in a single, unified lumen. In this configuration, a camera may be inserted through the unified lumen, with saline solution passing through the remaining cross- sectional area of the lumen. Element 4613 is a cautery hole that can contain the cautery wire for electrical connection to the cautery tip with an electrosurgical unit, and its diameter can range from 0.2 mm to 0.5 mm. Arc slot 4614 is formed between the outer wall of the barrel and the inner wall of the barrel 4616, and the cutting element which can be a tongue is located within during resting state. The slot can have an outer diameter of 5.4 mm or more, and a width of 0.2 to 0.5 mm or more. The arc slot 4614 can have different shapes and sizes in different segments of the barrel. The total arc angle of the arc slot can range from 60° to 120°. The edge of the arc slot can start from 40° to 50° from the horizontal axis. Element 4612 is a hole (with opposite corresponding hole) to receive the spikes of a cautery tip 4624. The multi lumen tubing can be manufactured through a process such as extrusion, micro molding, braiding with lumen insert, lamination with channel structures, or CNC (computer numerical control) machining.

[00341] FIG. 46C shows an enlarged view of distal tip 4602 that contains flat surface 4620, cautery tip attachment location 4621, and bevel 4622. As used herein, the term “bevel” and “chamfer” are used interchangeably. Element 4623 is the angle at which the tip is beveled, i.e. the “bevel angle”, relative to the longitudinal axis of the barrel. The camera can be mounted on flat surface 4620. In some cases the bevel angle is 10° to 80°, such as 45°, as shown in the figure. The longitudinal distance of the flat surface can range from 1 mm to 8 mm from the distal end, such as 2 mm to 3 mm. In a normal use, a longitudinal distance of 2mm to 4mm results in an horizon line affecting <50% of the functional visual field and provides sufficient distance to prevent camera soiling by direct clot contact during clot removal. Cautery tip attachment location 4621 is a slot for attachment of the cautery tip.

[00342] FIG. 46D shows the distal end with cautery tip 4624 attached. [00343] FIG. 46E shows a bottom view of the FIG. 46A device. In some cases, the handle has a height of 100 mm to 180 mm, such as 140 mm. In some cases the width of the handle is 20 mm to 60 mm, such as 30 mm. In some cases the handle has two section, such as a left section and a right section that are attached to one another, as shown in FIG. 46E. FIG. 46E also shows the bottom of the handle where connections 4607 emerge from the handle.

[00344] FIG. 47A shows internal components of a device. Dual-action trigger 4701 rotates around pivot boss 4702. Thus, when the trigger is depressed, it moves to the right, thereby pushing left on slider 4703 and right on piston 4704. The device also includes slider compression spring 4705 and piston compression spring 4706 that resist the depression of the trigger. Piston compression spring 4706 is also referred to as trigger spring 4706. The trigger length can range from 50 mm to 80 mm and its width can range from 10 mm to 30 mm at its widest point. Trigger boss 4702 can have a diameter of 3 mm to 8 mm. Trigger boss 4702 can include one or more bearings, such as deep groove ball bearings, thrust bearings, or roller bearings.

[00345] The trigger 4701 has a “home position” that is its angle when no pressure is applied from a user. In this home position, the trigger can be orientated at between 20° and 60° relative to a vertical axis, wherein the vertical axis is perpendicular to the horizontal longitudinal axis of the barrel. In the home position, aspiration tube 4707 is compressed between upper pinch boss 4708 and lower pinch boss 4709. Lower pinch boss 4709 is shown as a “bump” or half-circle in the figure. In some cases, each pinch boss can exert a cross-sectional shape selected from the group consisting of rectangular, elliptical, and oval. In some cases, a clearance of 0.5 mm to 0.25 mm is maintained between the outer faces of the upper pinch boss and the inner faces of the traversal slot of the piston.

[00346] FIG. 47B shows the device when the trigger is depressed to a first activation position.

[00347] FIG. 47C shows the trigger in its home position and FIG. 47D shows the trigger upon depression by 15°. The figures show vertical axis 4722, the trigger axis at home position 4721, and the trigger axis at first activation position 4723 due to depression by 15°. In some cases, first activation position is between 5° and 20° from the home position. Location 4724 is a section of aspiration tube 4707 that is either constricted or released due to the position of lower pinch boss

4709. Specifically, when the trigger moves from the home position to its first activation position, it causes slider 4704 and lower pinch boss 4709 to move towards the bottom-right of the figure, thereby releasing constriction at location 4724.

[00348] As shown in FIG. 47A, arm 4711 extends upwards from pivot boss 4702 and push element 4710 is located nearby. As shown by comparing FIGS. 47A and 47B, depressing the trigger by 15° causes arm 4711 to rotate leftwards by 15° and come into contact with element

4710. However, element 4710 does not move when the trigger is put into the first activation position. Thus, this arrangement of elements allows a first function to be performed (i.e. activation of aspiration) without activating the second function (i.e. related to elements 4710 and 4703).

[00349] FIGS. 47E and 47F show a top portion of the device in the home position and second activation position. The second activation position involves a further rotation from first activation position by 10° to 40°. This rotation causes arm 4711 to push knob 4710 to the left, thereby also pushing slider 4703 to the left. Slider 4703 is rigidly attached to an additional element that enters the barrel and terminates with a tongue cutting element. Thus, moving to the second activation position causes a tongue cutting element at the distal end of the barrel to move forward, thereby cutting biological tissue at the distal end of the barrel. The tongue is displaced 5 mm to 15 mm in some cases. Also present is guiding element boss 4799 that helps guide the movement of the slider. Guiding boss element 4799 is a protrusion extending from either side of the slider or the inner surface of a slot, with a cross-sectional shape of circular, oval, rectangular, or elliptical. Slider 4703 is displaced about 4 mm to 15 mm during activation. Slider 4703 can have an outer diameter of at least 14 mm and an inner diameter of 11.5 mm or less. The second activation position also allows the aspiration lumen to remain fully open.

[00350] As shown in FIG. 47A, the device also includes latch mechanism-based irrigation button 4712, upper pinch boss 4713, lower pinch boss 4714, and irrigation tube 4715.

[00351] FIG. 47G shows an enlarged view of the irrigation mechanism. Also present is housing 4716 and retainer plate 4717.

[00352] FIG. 47H shows an angled view of the section shown in FIG. 47G.

[00353] FIG. 471 shows a partially transparent region of the irrigation mechanism including hook 4718.

[00354] In its default, non-actuated state, the irrigation button pushes upwards until the lower pinch boss gets locked with the upper pinch boss. In this position, the irrigation tube is compressed between the upper pinch boss of the handle and the lower pinch boss of the irrigation button, inhibiting irrigation liquid flow. The upper and lower pinch bosses may each independently exhibit a cross-sectional shape selected from the group consisting of circular, rectangular, elliptical, and oval. A clearance of 0.05 mm to 0.25 mm is maintained between the outer faces of the upper pinch boss and the inner faces of the traversal slot of the irrigation button.

[00355] The irrigation button 4712 can travel a total distance of between 2 mm and 10 mm between its resting state and its actuated state. A clearance of 0.05 mm to 0.5 mm can be maintained between the outer faces of the irrigation button and the inner faces of the housing body. This precise clearance ensures smooth motion of the button, minimizes friction, and prevents unintended jamming during actuation. [00356] Upon depressing button 4712, the mechanism can engage hook 4718, which maintains the button in the activated state even after release of pressure, thereby maintaining the flow of irrigation liquid. Upon pressing the button again, the latching mechanism can disengage, thereby allowing fluid flow to stop upon release of pressure against the button.

[00357] The material of the parts of the irrigation subassembly can be polypropylene, ABS, polycarbonate, polyamide, polyethylene terephthalate (PET), or PEEK. In some cases the hook and retainer plate can be fabricated from a metal material.

[00358] FIG. 48A shows an embodiment of a distal end of the device including barrel 4801, tongue 4802, and location 4803. Tongue 4802 acts as cutting element when advanced across the main lumen of the barrel 4615 (for clarity, this tongue movement is considered actuation). Tongue 4802 travels along the bottom end of the barrel and then bends upwards at the distal end, contacting with a cautery tip 4624 as shown in FIG. 48A. Tongue 4802 and cautery tip 4624 can be electrically coupled to electrosurgical generator and provide electrocoagulation to bleeding vessels and tissue.

FIG. 48B shows a distal section of tongue 4802. Figure 48C shows an embodiment of a distal end of the device when the tongue 4802 is retracted in a resting position. Figure 48D shows an embodiment of a distal end of the device when the tongue 4802 is deployed in an actuated position. Figure 48E shows a side view of an embodiment of a distal end of the device when the tongue 4802 is deployed in an actuated position. As depicted in Fig 48B, in some embodiments tongue 4802 includes pusher section 4802a, neck 4802c, a paddle section 4802d with a cutting edge 4802b, and a stabilizer section 4802e. The paddle section 4802d is located at the distal segment of the tongue and has a geometry and area substantially similar to the aperture of the main lumen of the barrel 4615. The paddle section 4802d resides at a resting state inside the arc slot 4614 and conformed as a partial arc. During tongue 4802 actuation the paddle section 4802d emerges from the arc slot and bends upwards, swiping the opening of the main lumen of the barrel 4614. In this process the paddle geometry changes from arc to flat. The complex changes in geometrical shape can be obtained by pre-shaping a hyperplastic material (such as nitinol) to have a flat paddle (in cross-section) with a curve upwards (extending the curve into the neck) when looked sideways. At rest, the paddle 4802d is forced to comply with the shape of the arc slot 4614 resulting in an arched paddle in cross-section and straight sideways. During actuation, the paddle 4802d emerges from the arc slot 4614 and the accumulate elastic energy is released inducing a change into the unconstraint stage of a flat paddle 4802d with an upward bend. The latter results in optimal apposition of the paddle 4802d to the main lumen of the barrel during deployment and achieves full contact of the cutting edge 4802b with the opposing cautery tip 4624. [00359] The pusher section 4802a is located inside the arc slot 4614 and is mechanically coupled to the slider 4703 for anterograde longitudinal translation when the trigger 4701 is pulled. The pusher section 4802a can have one of the following cross-sectional shapes: circular, oval, square, start, diamond, rectangular, flat, curved, or a combination thereof. The receiving lumen conforms to the shape of the pusher section 4802a to prevent waving and lateral translation while minimizing friction and buckling. The pusher section 4802a continues distally with a stabilizer section 4802d which is sized and shaped to substantially fit and match the geometry of the arc slot 4614 to minimize friction during longitudinal displacement. The pusher section 4802a remains within the arc slot 4614 of the barrel during advancement and retraction of the tongue preventing unwanted lateral translation, angulation and rotation. This stabilization mechanism by the tongue segment inside the arc slot 4614 result in a parallel advancement and retraction between the tongue cutting edge 4802b and the cautery tip 4624. The cutting edge 4802b has a shape that is perpendicular to the longitudinal axis of the tongue and fully contacts the cautery tip 4624 when the tongue is maximally advanced. The equidistance between each segment of the tongue cutting edge 4802b and the cautery tip 4624 at any given point facilitates clot cutting and vascular compression with hemostasis of vessels drawn inside the main lumen 4614 by vacuum upon full contact. In some embodiments, other stabilizing mechanism between the tongue and the barrel can exist including rails, slots and ridges. The neck 4802c of the tongue consists in a narrower segment proximal to the paddle section 4802d. The neck 4802c facilitates the cross-section geometrical changes of the paddle section 4802d from the pre-set flat shape when deployed and covering the main lumen of the barrel 4515, to the arched (curved) shape when pulled back and constrained inside the arc slot 4614. The neck 4802c also facilitates the longitudinal geometrical changes from the pre-set bent shape when deployed and covering the main lumen of the barrel 4515, to the straight shape when pulled back and constrained inside the arc slot 4614. The neck 4802c reduces stress concentration and reduces the forces required to induce the geometrical changes during egress and ingress of the tongue in the arc slot 4614.

[00360] In some embodiments, tongue 4802 is electrically coupled to electrosurgical generator and insulated except the cutting edge 4802b.

[00361] In some cases, the tongue paddle 4802d can have at least one hole to maintain suction into the main lumen 4615 during full deployment of the tongue 4802.

[00362] In some embodiments, the tongue cutting edge 4802b and the cautery tip 4624 can have matching non-straight shapes, such as arc shape.

In some cases, the tongue is formed in a planar shape. In some cases, the tongue is formed as an arcuate shape, as shown in FIG. 48C. The tongue is designed to move in a predetermined arc when activated, thereby cutting the desired body material. In some cases, the inner diameter of the arc is from 4 mm to 6 mm. In some cases, the outer diameter of the arc is from 5 mm to 7 mm. In some cases, the arc ranges from 10° to 270°, such as about 165°. In some cases, the elongated body has filleted corners, which involves a rounded transition between adjacent surfaces, minimizing stress concentrations and reducing the risk of tissue trauma during tongue manipulation. The radius of the fillet can range from 1 mm to 25 mm. In some cases, the tongue can include a shape memory alloy, such as a nickel titanium alloy of roughly equal atomic percentages (e.g. where each element ranges from 40% to 60% by atomic percentage) (i.e. nitinol). In some cases, the neck of the tongue can have a width of 1 mm to 4 mm. The tongue can have a thickness ranging from 0.05 mm to 0.3 mm in some cases. In some instances, the neck is located 5 mm to 20 mm from the distal cutting end of the tongue.

[00363] Exemplary materials that can be used for the barrel, distal end, and tongue include shape memory alloys (e.g. nitinols), stainless steel (e.g. 304 or 316L stainless steel) that can have high strength and corrosion resistance, and biocompatible polymers (e.g. PEEK, polytetrafluoroethylene (PTFE), perylene, polyimide which can enhance biocompatibility, lubricity, or electrical insulation.

[00364] The barrel can be configured to deliver electrical energy to the target tissue, such as monopolar energy or bipolar energy. Monopolar energy: delivering energy from a single electrode on the device to a grounding pad placed elsewhere on the patient's body, enabling broad tissue effects. The electrode may be fabricated from a conductive material such as platinum, iridium, or stainless steel. Bipolar energy: deliver energy between two electrodes located on the device, providing localized energy delivery for precise tissue treatment. The electrodes may be formed from similar materials as in the monopolar configuration. Bipolar energy can be provided between the cutting edge of the tongue and the cautery tip.

[00365] FIG. 49 shows a perspective view and a side view of a distal end with cautery tip 4901. The cautery tip 4901 is located around the circumference of the main opening in the barrel. The cautery tip can be configured as an annular or ring shaped structure. The method can include using suction to draw the biological structure into the opening and then applying an electrical current through the cautery tip to cauterize the bleeding blood vessel or tissue. In some cases the width of the cautery tip, as measured radially from the inner edge to the outer edge of the cautery dip, ranges from 0.5 mm to 5 mm. The cautery tip can also be another shape, such as a linear electrode, a hook, a sphere, or a disc. Exemplary materials of the cautery tip include stainless steels (e.g. 304 or 316L), platinum, iridium, or a hiocompatible metal or alloy. Pt/Pt-Ir alloys offer superior biocompatibility, corrosion resistance, and reduced tissue adhesion compared to stainless steel. They also possess good electrical conductivity and can be formed into thin, flexible shapes. Pt-Ir alloys provide increased hardness and durability relative to pure Pt. These properties have led to their widespread use in neurosurgical electrodes, including DBS leads, cortical grids, and depth electrodes. 316LVM stainless steel, a low carbon, vacuum- melted grade, presents a cost-effective alternative with acceptable biocompatibility, strength, and durability. However, it is known to exhibit a higher propensity for tissue adhesion than Pt/Pt-Ir. 316LVM stainless steel is often employed for temporary electrodes and has been utilized in monopolar cautery instruments.

[00366] The cautery tip can be configured to snap-fit to the barrel with complementary snapping elements on the cautery tip and barrel. In other cases, the cautery tip is attached through an adhesive (e.g. cyanoacrylate, epoxy resin, UV-curable).

[00367] FIG. 53A shows a distal end in a resting position, and FIG. 53B shows it in an actuated position. The various parts of the cutting element including cutting edge 5302 and neck 5304 move distally upon activation. FIG. 53C shows a side view.

[00368] Although the foregoing invention has been described in some detail by way of illustration and example for purposes of clarity of understanding, it is readily apparent to those of ordinary skill in the art in light of the teachings of this invention that certain changes and modifications may be made thereto without departing from the spirit or scope of the appended claims.

[00369] Accordingly, the preceding merely illustrates the principles of the invention. It will be appreciated that those skilled in the art will be able to devise various arrangements which, although not explicitly described or shown herein, embody the principles of the invention and are included within its spirit and scope. Furthermore, all examples and conditional language recited herein are principally intended to aid the reader in understanding the principles of the invention and the concepts contributed by the inventors to furthering the art, and are to be construed as being without limitation to such specifically recited examples and conditions. Moreover, all statements herein reciting principles, aspects, and embodiments of the invention as well as specific examples thereof, are intended to encompass both structural and functional equivalents thereof. Additionally, it is intended that such equivalents include both currently known equivalents and equivalents developed in the future, i.e., any elements developed that perform the same function, regardless of structure. Moreover, nothing disclosed herein is intended to be dedicated to the public regardless of whether such disclosure is explicitly recited in the claims.

[00370] The scope of the present invention, therefore, is not intended to be limited to the exemplary embodiments shown and described herein. Rather, the scope and spirit of present invention is embodied by the appended claims. In the claims, 35 U.S.C. 112(f) is expressly defined as being invoked for a limitation in the claim only when the exact phrase "means for" or the exact phrase "step for" is recited at the beginning of such limitation in the claim; if such exact phrase is not used in a limitation in the claim, then 35 U.S.C. 112(f) is not invoked.

Claims

CLAIMS What Is Claimed Is:

1. A sheath for determination of three-dimensional spatial orientation and removal of hemorrhagic blood from a body region of a patient, the sheath comprising a tubular member comprising: a proximal end comprising a proximal opening; a distal end comprising a distal opening; a spatial alignment element; a longitudinal axis extending from the proximal opening to the distal opening; a middle wall extending from the proximal opening to the distal opening; and a lumen defined by the proximal opening, the middle wall, and the distal opening.

2. The sheath of claim 1 , wherein the sheath further comprises a handle attached to the middle wall or the proximal end.

3. The sheath of claim 1, wherein the proximal end comprises a flange that has a larger cross section than a cross section of the middle wall.

4. The sheath of claim 1 , wherein the proximal end comprises a flange that has a larger cross section than the cross section of the middle wall, wherein the sheath further comprises a handle attached to the flange.

5. The sheath of any one of claims 1-4, wherein the middle wall has a circular cross section.

6. The sheath of any one of claims 1-5, wherein the tubular member has an inner diameter of 6 mm or less.

7. The sheath of any one of claims 1-6, wherein the spatial alignment element is at least one fiducial alignment element.

8. The sheath of claim 7, wherein the fiducial alignment element comprises a proximal fiducial marker at the proximal end and a distal fiducial marker at the distal end.

9. The sheath of any one of claims 1-8, wherein the sheath comprises a material with sufficient radio-opacity to act as a fluoroscopic marker when its longitudinal axis is aligned to a central x- ray beam.

10. The sheath of any one of claims 1-9, wherein both the proximal fiducial marker and the distal fiducial marker each comprise an open-circle cross-section.

11. The sheath of any one of claims 1-10, wherein the cross-sections of the proximal fiducial marker and the distal fiducial marker overlap when viewed along the longitudinal axis.

12. The sheath of any one of claims 1-10, wherein the cross-sections of the proximal fiducial marker and the distal fiducial marker do not overlap and instead form concentric circles when viewed along the longitudinal axis.

13. The sheath of any one of claims 1-12, wherein the proximal fiducial marker comprises an open-circle cross-section and the distal fiducial marker comprises a closed-circle cross-section.

14. The sheath of any one of claims 1-12, wherein the proximal fiducial marker comprises an open-circle cross-section and the distal fiducial marker comprises two perpendicular lines.

15. The sheath of any one of claims 1-14, wherein the proximal and distal fiducial marker are fluoroscopic markers.

16. The sheath of claim 15, wherein the proximal and distal fluoroscopic markers are X-ray fluoroscopic markers.

17. The sheath of any one of claims 1-14, wherein the proximal and distal fiducial markers are magnetic markers.

18. The sheath of any one of claims 1-6, wherein the spatial alignment element is a laser alignment element.

19. The sheath of claim 18, wherein the laser alignment element comprises a proximal laser alignment element at the proximal end.

20. A trocar for simple determination of 3 -dimensional spatial orientation and removal of hemorrhagic blood from a body region of a patient, the trocar comprising: a proximal end comprising a proximal opening; a closed distal end; a spatial alignment element; a longitudinal axis extending from the proximal opening to the distal opening; a central wall extending from the proximal end to the closed distal end; and a lumen defined by the proximal opening, the central wall, and the closed distal end.

21. The trocar of claim 20, wherein the closed distal end extends more distally than the middle wall section.

22. The trocar of claim 21, wherein the closed distal end extends 1 mm or more in the distal direction than the middle wall section.

23. The trocar of any one of claims 20-22, wherein the closed distal end has a conical shape.

24. The trocar of claim 23, wherein the closed, conical distal end makes an angle of between 110° and 170° with the central wall.

25. The trocar of any one of claims 20-24, wherein the trocar further comprises a handle attached to the central wall or the proximal end.

26. The trocar of any one of claims 20-25, wherein the proximal end comprises a flange that has a larger cross section than a cross section of the central wall.

27. The trocar of any one of claims 20-26, wherein the proximal end comprises a flange that has a larger cross section than the cross section of the central wall, wherein the trocar further comprises a handle attached to the flange.

28. The trocar of any one of claims 20-27, wherein the spatial alignment element is a fiducial alignment element.

29. The trocar of claim 28, wherein the fiducial alignment element comprises a proximal fiducial marker at the proximal end and a distal fiducial marker at the distal end.

30. The trocar of claim 28 or 29, wherein both the proximal fiducial marker and the distal fiducial marker each comprise an open-circle cross-section.

31. The trocar of any one of claims 28-30, wherein the cross-sections of the proximal fiducial marker and the distal fiducial marker overlap when viewed along the longitudinal axis.

32. The trocar of any one of claims 28-30, wherein the cross-sections of the proximal fiducial marker and the distal fiducial marker do not overlap and instead form concentric circles when viewed along the longitudinal axis.

33. The trocar of any one of claims 28-32, wherein the proximal fiducial marker comprises an open-circle cross-section and the distal fiducial marker comprises a closed-circle cross-section.

34. The trocar of any one of claims 28-32, wherein the proximal fiducial marker comprises an open-circle cross-section and the distal fiducial marker comprises two perpendicular lines.

35. The trocar of any one of claims 28-34, wherein the proximal and distal fiducial marker are fluoroscopic markers.

36. The trocar of claim 35, wherein the proximal and distal fluoroscopic markers are X-ray fluoroscopic markers.

37. The trocar of any one of claims 28-34, wherein the proximal and distal fiducial markers are magnetic markers.

38. The trocar of any one of claims 20-27, wherein the spatial alignment element is a laser alignment element.

39. The trocar of claim 38, wherein the laser alignment element comprises a proximal laser alignment element at the proximal end.

40. An insertion assembly of both a sheath and trocar, the insertion assembly comprising: a sheath of any one of claims 1-19; a trocar of any one of claims 20-39; wherein the outer diameter of the central wall of the trocar and the inner diameter of the middle wall of the sheath are configured such that the trocar can be inserted into the lumen of the sheath.

41. The insertion assembly of claim 40, wherein the trocar is inserted into the lumen of the sheath.

42. The insertion assembly of any one of claims 40-41, wherein the central wall of the trocar exerts an expansive force on the middle wall of the sheath.

43. The insertion assembly of any one of claims 40-42, wherein the proximal end of the trocar comprises a flange that has a larger cross section than the cross section of the central wall of the trocar, wherein the flange has a larger cross section than the proximal end of the sheath, thereby preventing complete insertion of the trocar into the sheath.

44. A drill guide for simple determination of 3 -dimensional spatial orientation, comprising a tubular member comprising: a proximal end comprising a proximal opening; a distal end comprising a distal opening; a spatial alignment element; a longitudinal axis extending from the proximal opening to the distal opening; a core wall extending from the proximal opening to the distal opening; and a lumen defined by the proximal opening, the core wall, and the distal opening.

45. The drill guide of claim 44, further comprising a base with spatial alignment element includes ball joints, articulating arms or adjustable-height spikes.

46. The drill guide of any one of claims 44-45, further comprising an anchoring mechanism between the drill guide base and the skull to temporarily fix their 3D relationship.

47. The drill guide of any one of claims 44-46, further comprising a locking mechanism to maintain the selected trajectory of the tubular member of the drill guide

48. A blood removal device for removing hemorrhagic blood from a body region of a patient, the blood removal device comprising: a barrel comprising a proximal end, a distal end, an irrigation channel extending from the proximal end to the distal end, and a suction channel extending from the proximal end to the distal end; a camera positioned at the distal end of the barrel; a handle coupled to the proximal end of the barrel; an irrigation activator; and a suction activator.

49. The blood removal device of claim 48, further comprising a lighting element.

50. The blood removal device of any one of claims 48-49, further comprising a visual display operably connected to the camera.

51 . The blood removal device of any one of claims 48-50, further comprising a cutting element and a cutting element activator.

52. The blood removal device of claim 51, further comprising a cutting element channel extending from the proximal end to the distal end, wherein the cutting element extends from the proximal end, through the cutting element channel, to the distal end.

53. The blood removal device of claim 52, wherein the cutting element channel is located below the suction channel.

54. The blood removal device of any one of claims 51-53, wherein the cutting element comprises a cutting edge located at the distal end, a neck adjacent to the cutting edge, and a central section located adjacent to the neck, wherein the neck has a smaller cross section than a cross section of the central section and a cross section of the cutting edge.

55. The blood removal device of any one of claims 51-54, wherein activating the cutting element activator causes the cutting element to move in the distal direction and the cutting edge to move upwards in front of the suction channel and contact another part of the barrel.

56. The blood removal device of any one of claims 48-55, further comprising a main opening located at the distal end of the barrel, wherein the distal end of the suction channel is located inside the main opening.

57. The blood removal device of claim 56, wherein the main opening has a top edge and a bottom edge, wherein the top edge of the main opening is located more distally than the bottom edge of the main opening.

58. The blood removal device of any one of claims 48-57, further comprising an auxiliary opening located at the distal end of the barrel, wherein the camera is positioned at the auxiliary opening.

59. The blood removal device of claim 58, wherein the auxiliary opening is located more proximally than any part of the main opening.

60. The blood removal device of any one of claims 58-59, wherein the distal end of the irrigation channel is located at the auxiliary opening.

61. The blood removal device of any one of claims 48-60, further comprising a depressible button located: (i) at a top surface of a housing, and (ii) within the proximal half of the housing, wherein the depressible button is the activator of irrigation or the activator of suction.

62. The blood removal device of claim 61, wherein the depressible button is connected to a first pinch boss located adjacent to a first tube inside the handle, wherein moving the depressible button moves the first pinch boss, thereby compressing or releasing compression of the first tube.

63. The blood removal device of any one of claims 61-62, wherein the depressible button is the activator of irrigation, wherein the first tube is connected to the irrigation channel, wherein depressing the depressible button releases compression of the first tube and causes irrigation liquid to flow into the irrigation channel.

64. The blood removal device of any one of claims 61-63, further comprising a button latching mechanism configured to retain the depressible button in a depressed location until force is released and then applied a second time to the depressible button.

65. The blood removal device of any one of claims 48-64, further comprising a trigger attached to and configured to rotate around a pivot boss, wherein: the trigger is an activator of suction or an activator of irrigation, the trigger is optionally an activator of a cutting element, the trigger has a home position, a first activation position, and a second activation position that are each defined by a particular angular rotation around the pivot boss, the trigger is located more proximally in the first activation position than in the home position, the trigger is located more proximally in the second activation position than in the first activation position.

66. The blood removal device of claim 65, further comprising a trigger spring that pushes the trigger in a distal direction.

67. The blood removal device of any one of claims 65-66, wherein the angular difference between the home position and the first activation position ranges from 5° to 45°.

68. The blood removal device of any one of claims 65-67, wherein the angular difference between the first activation position and the second activation position ranges from 5° to 45°.

69. The blood removal device of any one of claims 65-68, wherein the trigger is connected to a second pinch boss located adjacent to a second tube, wherein rotating the trigger around the pivot boss moves the second pinch boss, thereby compressing or releasing compression on the second tube.

70. The blood removal device of claim 69, wherein the second tube is connected to the suction channel, wherein the trigger is an activator of suction and rotating the trigger from the home position to the first activation position causes the second pinch boss to release compression on the second tube and allow a suction force to be exerted through the suction channel.

71. The blood removal device of any one of claims 69-70, wherein the second tube remains in an uncompressed state upon moving the trigger from the first activation position to the second activation position or beyond the second activation position.

72. The blood removal device of any one of claims 65-71, wherein: an arm is attached to the pivot boss and the trigger, rotation of the trigger around the pivot boss causes rotation of the arm around the pivot boss by the same angular amount, the angle formed by the trigger, the pivot boss, and the arm ranges from 100° to 180°, the arm is not in contact with a push element when the trigger is in the home position or the first activation position, the arm contacts the push element upon rotation of the trigger from the first activation position to the second activation position, rotation of the trigger past the second activation position causes the arm to push on the push element and move the push element in a distal direction, the push element is connected to the cutting element such that movement of the push element in the distal direction causes the cutting element to move in a distal direction, thereby exerting a cutting force on material present at a cutting location at the distal end of the barrel.

73. The blood removal device of any one of claims 48-72, further comprising a housing that surrounds one or more elements of the device, wherein the activator of suction, the activator of irrigation, and the optional activator of the cutting element are located at least partially outside the housing.

74. The blood removal device of claim 73, wherein: a horizontal axis intersects the proximal end and the distal end of the barrel, a vertical axis is perpendicular to the horizontal axis, wherein the vertical axis also intersects the housing at one or more points, the housing includes a top section that encompasses part of the horizontal axis, the housing includes a vertical section that encompasses part of the vertical axis, the top section ranges from 1 cm to 5 cm in height and from 3 cm to 10 cm in width along the horizontal axis, and the vertical section ranges from 4 cm in height to 9 cm in height and from 2 cm to 6 cm in width along the horizontal axis.

75. The blood removal device of any one of claims 73-74, wherein the housing has an L-shape, wherein the trigger is located on the inside comer of the L-shape and the button is located on the outside comer of the L-shape.

76. The blood removal device of any one of claims 48-75, further comprising a cutting element positioned at the distal end and an activator of the cutting element.

77. The blood removal device of claim 76, wherein the cutting element is positioned within the suction channel at the distal end.

78. The blood removal device of any one of claims 48-77, further comprising an electrocoagulation element.

79. The blood removal device of claim 78, wherein the electrocoagulation element is a cautery tip.

80. The blood removal device of any one of claims 78-79, wherein the electrocoagulation element comprises a metal electrode located at the distal end.

81. The blood removal device of any one of claims 78-80, wherein at least a part of the electrocoagulation element is located along the entire edge of a main opening located at the distal end of the barrel.

82. The blood removal device of any one of claims 48-81, further comprising an image export element.

83. The blood removal device of any one of claims 48-82, wherein a lighting element of the device is positioned at the distal end of the barrel.

84. The blood removal device of claim 83, wherein the lighting element comprises a light pipe comprising a light outlet at the distal end of the barrel.

85. A method of removing hemorrhagic blood from a body region of a patient, the method comprising: providing a sheath comprising: a proximal end comprising a proximal opening; a distal end comprising a distal opening; a longitudinal axis extending from the proximal opening to the distal opening; a middle wall extending from the proximal opening to the distal opening; and a lumen defined by the proximal opening, the middle wall, and the distal opening, optionally providing a trocar comprising: a proximal end comprising a proximal opening; a closed distal end; a central wall extending from the proximal end to the closed distal end; and a lumen defined by the proximal opening, the central wall, and the closed distal end, wherein a spatial alignment element is present as a part of the tubular member of the sheath or as a part of the tubular member of the trocar; forming an insertion assembly comprising the sheath and optionally further comprising the trocar inserted into the lumen of the sheath, recording initial images of the hemorrhagic blood and the body region; selecting a desired trajectory for the insertion assembly from an entry site at an exterior surface of the body region to a destination site at the hemorrhagic blood based on the recorded images; optionally removing bone at the entry site using a drill and a drill guide of any one of claims 44-47 ; approximately aligning the longitudinal axis of the sheath with the desired trajectory; assessing the alignment between the longitudinal axis of the sheath and the desired trajectory based on a spatial alignment element of the insertion assembly; adjusting the sheath so that its longitudinal axis is more closely aligned with the desired trajectory based on the assessment; inserting the insertion assembly into the body region to a desired depth such that the distal end of the sheath reaches the hemorrhagic blood; if present, removing the trocar from inside the sheath; removing at least some of the hemorrhagic blood from the body region through the sheath.

86. The method of claim 85, wherein the insertion assembly comprises the sheath but not the trocar.

87. The method of claim 85, wherein the insertion assembly comprises the sheath and the trocar.

88. The method of any one of claims 85-87, wherein the spatial alignment element is a fiducial alignment element comprising at least one fiducial marker with sufficient extension along the longitudinal axis of the insertion assembly, or a proximal fiducial marker at a proximal end of the tubular member of the sheath or the trocar, and a distal fiducial marker at a distal end of the tubular member of the sheath or the trocar.

89. The method of any one of claims 85-88, wherein assessing the alignment comprises:

(a) aligning a fiducial imaging device with the desired trajectory;

(b) recording an alignment fiducial image with the fiducial imaging device that shows the proximal fiducial marker and the distal fiducial marker;

(c) determining the relative angles between the longitudinal axis of the sheath and the desired trajectory based on the appearances of the proximal fiducial marker and the distal fiducial marker in the alignment fiducial image.

90. The method of any one of claims 85-89, wherein the proximal and distal fiducial markers are proximal and distal fluoroscopic markers, wherein the fiducial imaging device is a fluoroscopic imaging device.

91. The method of claim 90, wherein the proximal and distal fluoroscopic markers are proximal and distal X-ray fluoroscopic markers, wherein the fiducial imaging device is an X-ray imaging device.

92. The method of any one of claims 85-87, wherein the proximal and distal fiducial markers are proximal and distal magnetic markers, wherein the fiducial imaging device is a magnetic resonance imaging (MRI) imaging device.

93. The method of any one of claims 85-92, wherein the cross-sections of the proximal fiducial marker and the distal fiducial marker overlap when viewed along the longitudinal axis.

94. The method of any one of claims 85-92, wherein the cross-sections of the proximal fiducial marker and the distal fiducial marker do not overlap and instead form concentric circles when viewed along the longitudinal axis.

95. The method of any one of claims 85-94, wherein the proximal fiducial marker comprises an open-circle cross-section and the distal fiducial marker comprises a closed-circle cross-section.

96. The method of any one of claims 85-94, wherein the proximal fiducial marker comprises an open-circle cross-section and the distal fiducial marker comprises two perpendicular lines.

97. The method of any one of claims 85-87, wherein the spatial alignment element is a laser alignment element positioned at the proximal end of the tubular member of the sheath or the trocar, and wherein assessing the alignment comprises: (a) emitting laser light from a laser light alignment source along the desired trajectory and towards the laser light alignment element;

(b) evaluating which surfaces of the laser alignment element are contacted by the laser light;

(c) determining the relative angles between the longitudinal axis of the sheath and the desired trajectory based on the evaluating.

98. The method of claim 97, wherein the laser light alignment element comprises elements parallel to the longitudinal axis of the device including color lines and pillars.

99. The method of claim 97 or 98, wherein the laser light alignment element comprises elements perpendicular to the longitudinal axis of the device including surfaces, orientation lines, flanges, wings, grooves, or ridges.

100. The method of any one of claims 85-99, wherein the tubular member of the sheath comprises depth indications on an external surface of the middle wall that extend along the longitudinal axis from the distal end, wherein inserting the insertion assembly into the body region to the desired depth comprises:

(a) determining a target depth indication that corresponds to the desired depth; and

(b) inserting the insertion assembly until the target depth indication is at the external surface of the body region.

101. The method of any one of claims 85-100, wherein inserting the tubular member into the body region to a desired depth comprises:

(a) moving the distal end of the tubular member a first distance into the body region;

(b) capturing a first depth fiducial image of the distal fiducial marker from an angle that is at least 10° away from the desired trajectory;

(c) determining the location of the distal end of the sheath in relation to the destination site from the captured first depth fiducial image;

(d) if the distal end was determined to be outside the destination site, repeating the moving, capturing, and determining by:

(i) moving the distal end of the sheath to a new depth inside the body region;

(ii) capturing a new depth fiducial image of the distal fiducial marker from an angle that is from 10° away to 90° away from the desired trajectory;

(iii) determining the new location of the distal end of the catheter in relation to the destination site from the captured new depth fluoroscopic image; wherein the repeating can be performed one or more times.

102. The method of claim 101, wherein the first depth fiducial image is captured from an angle that is from 40° away to 90° away the desired trajectory.

103. The method of any one of claims 85-102, wherein removal of the hemorrhagic blood comprises applying suction through the lumen of the tubular member.

104. The method of any one of claims 85-103, wherein removal of the hemorrhagic blood comprises: inserting the distal end of the barrel of a blood removal device of any one of claims 48- 84 into the sheath; and activating the suction activator, thereby causing suction to move the hemorrhagic blood into the barrel of the blood removal device.

105. The method of any one of claims 85-104, wherein activating the suction activator comprises moving a trigger of the blood removal device from a home position to a first activation position.

106. The method of any one of claims 85-105, wherein removal of the hemorrhagic blood further comprises: activating the electrocoagulation element and thereby coagulating blood, stopping the bleeding of a blood vessel, or a combination thereof at the destination site.

107. The method of any one of claims 85-106, wherein removal of the hemorrhagic blood further comprises: observing the destination site through a visual display.

108. The method of any one of claims 85-107, wherein removal of the hemorrhagic blood further comprises: activating the cutting element to cut material at the destination site and then removing the cut material through the suction channel.

109. The method of claim 108, wherein activating the cutting element comprises moving a trigger of the blood removal device from a first activation position to a second activation position.

110. The method of claim 108 or 109, wherein the cut material comprises coagulated blood.

111. The method of any one of claims 85- 110, wherein removal of the hemorrhagic blood further comprises: activating the irrigation activator, thereby causing irrigation liquid to move through the irrigation channel and into the destination site, wherein the activation of the irrigation activator begins before, during, or after the activation of the suction activator.

112. The method of any one of claims 85-111, wherein the removing of at least some of the hemorrhagic blood through the sheath is performed within 120 minutes or less of the recording of the initial fiducial image.

113. The method of any one of claims 85-112, further comprising:

(a) moving a camera through the sheath and to the distal end of the catheter;

(b) visually observing the destination site with the camera.

114. The method of any one of claims 85-113, wherein the body region is the patient’s head and the hemorrhagic blood is located in the patient’s brain.

115. The method of any one of claims 85-114, wherein the method includes removing bone at the entry site using a drill and a drill guide.

116. The method of any one of claims 85-115, wherein the method comprises removing bone at the entry site using the drill and the drill guide.

117. The method of claim 116, wherein removing the bone comprises performing a burrhole, a craniotomy, or a craniectomy.