|Número de publicación||WO2016053778 A1|
|Tipo de publicación||Solicitud|
|Número de solicitud||PCT/US2015/052152|
|Fecha de publicación||7 Abr 2016|
|Fecha de presentación||25 Sep 2015|
|Fecha de prioridad||29 Sep 2014|
|También publicado como||EP3200705A1|
|Número de publicación||PCT/2015/52152, PCT/US/15/052152, PCT/US/15/52152, PCT/US/2015/052152, PCT/US/2015/52152, PCT/US15/052152, PCT/US15/52152, PCT/US15052152, PCT/US1552152, PCT/US2015/052152, PCT/US2015/52152, PCT/US2015052152, PCT/US201552152, WO 2016/053778 A1, WO 2016053778 A1, WO 2016053778A1, WO-A1-2016053778, WO2016/053778A1, WO2016053778 A1, WO2016053778A1|
|Solicitante||Clearmind Biomedical, Inc.|
|Exportar cita||BiBTeX, EndNote, RefMan|
|Citas de patentes (9), Clasificaciones (16), Eventos legales (4)|
|Enlaces externos: Patentscope, Espacenet|
CROSS REFERENCE TO RELATED APPLICATIONS
 This application claims the benefit of U.S. Provisional Application No. 62/056,617, filed on September 29, 2014, and entitled "Surgical Device"; U.S. Provisional Application No.
62/063,1 14, filed on October 13, 2014, and entitled "Surgical Tool"; and U.S. Provisional Application No. 62/084,584, filed on November 26, 2014, and entitled "Surgical Tool", the entire disclosures of which are incorporated by reference herein in their entireties. INCORPORATION BY REFERENCE
 All publications and patent applications mentioned in this specification are incorporated herein by reference in their entirety to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference. FIELD
 This application generally relates to the field of surgical tools for the treatment of cerebral hemorrhage.
 Spontaneous, non-traumatic intracerebral hemorrhage (SICH) is a significant cause of morbidity and mortality throughout the world. There is a higher incidence in Asian with over 100,000 deaths and approximately 300,000 disabilities annually in China. In China, there are greater than 150,000 patients with SICH for minimally invasive surgical treatment every year.
 While patients present with small intracerebral hemorrhages (ICHs) that are readily survivable with good medical care, patients with large ICHs respond poorly to medical treatment. Traditional surgery does not show benefit in majority of these patients either.
 Minimally invasive surgery (MIS) has been developed to remove ICH with minimal damage to the brain (as compared to the traditional surgery). These techniques tend to make use of stereotactic guidance combined with either thrombolytic enhanced or endoscopic enhanced aspiration. Both randomized trials of thrombolytic enhanced aspiration for subcortical ICH and endoscopic enhanced aspiration with or without stereotaxis have reported increased clot removal and decreased mortality. However, MIS is not available in many hospital facilities, and the MIS surgery requires a steep learning curve. Additionally, current MIS methods generally utilize a working port(s) of an endoscope, and separate tools are advanced through the working port(s) towards the ICH. Such an approach can involve using a relatively large diameter endoscope, as the scope is not specialized for the tools used during MIS of an ICH. A large diameter endoscope will involve creating a correspondingly large hole in the cranium and using a large brain tissue path between the hole and the clot, which increases the risk for damage of a greater amount of brain tissue. Additionally, using an endoscope and working port(s) for the surgery involves separate insertion and removal steps for the scope and the various tools, which can increase surgery time and complicate the surgical method.
SUMMARY OF THE DISCLOSURE
 One aspect of the invention provides a surgical tool for removing tissue, such as a blood clot, from a cranium of a patient. In some embodiments, the tool has a handle; a shaft extending from a distal end of the handle and comprising a bendable distal tip, the shaft having an outer diameter less than or equal to 15 mm; an aspiration lumen extending along the shaft; an irrigation lumen extending along the shaft; a first conductor extending along the shaft and connectable at its proximal end to an image display; and a second conductor extending along the shaft and connectable at its proximal end to illumination power. In some embodiments, the first conductor is an electrical conductor connected to an image sensor (such as a CMOS or CCD) disposed at the distal tip. In some embodiments, the second conductor is an optical fiber connectable at its proximal end to a light source.
 Some embodiments of the tool also have a steering lever attached to a proximal end of the handle, wherein bending the steering lever bends the distal tip. In some such embodiments, bending the steering lever in a first direction causes the distal tip to bend a second direction different from the first direction, and in some such embodiments, bending the steering lever in a first direction causes the distal tip to bend in the first direction. In some embodiments, a ratio between an amount of bending of the steering lever and a corresponding amount of bending of the distal tip is adjustable. Some embodiments have a wire connecting the steering lever to the distal tip, and tension of the wire may be adjustable. In some embodiments, the steering lever is biased to so that a longitudinal axis of the steering lever is aligned with a longitudinal axis of the handle.
 In some embodiments, the tool has a stop (such as an elastic element) configured to prevent over insertion of the shaft into the cranium.
 Some embodiments of the tools also have a cap disposed distal to the distal tip of the shaft. The cap may have, e.g., a mushroom shaped tip or a fern shaped tip.
 In some embodiments, the tools includes a positioner configured to position the shaft with respect to an opening in the cranium. For example, the positioner may have an outer member configured to be positioned on the opening in the cranium and an inner member disposed within the outer member, the inner member including an aperture for insertion of the shaft therethrough. The positioner may also have indicators configured to indicate an orientation of the inner member to the outer member or to the cranium.
 In another example, the positioner may have a lower portion configured to be inserted into a hole in the cranium and an upper portion configured to rest on at least a portion of the cranium surrounding the hole, with the positioner also having an aperture for insertion of the shaft therethrough. In such embodiments, a top surface of the aperture may be wider than a bottom surface of the aperture, with the top surface having a material configured to allow passage of the shaft therethrough and to set the shaft in a desired location and orientation.
 Some embodiments of the positioner have two legs extending from a top member, with an angle between the two legs being adjustable, a bottom end of the two legs being connected to a bottom member, wherein the top member and the bottom member each have apertures configured to permit passage of the shaft therethrough.
 In some embodiments of the tool, a distal end of the aspiration lumen is configured to be extended distally beyond the distal tip of the shaft.
 Another aspect of the invention provides a method for removing tissue, such as a blood clot, from a cranium of a patient. In some embodiments the method includes the steps of inserting a shaft of a surgical tool into an opening in a cranium of a patient positioned above a region containing the blood clot, the opening in the cranium comprising a diameter less than about 15 mm; illuminating the region via a first light conductor extending through the shaft; visualizing the region via a second light conductor extending through the shaft; and applying suction to the region through an aspiration lumen extending through the shaft, thereby removing at least a portion of the blood clot from the region.
 Some embodiments of the method include after the inserting step a step of bending a distal tip of the shaft with respect to a proximal portion of the shaft. In some such embodiments, the bending step includes a step of adjusting a relationship between a steering lever and the shaft, such as by adjusting tension on a wire connecting the steering lever and the distal tip of the shaft.
 In some embodiments of the method, the step of inserting the shaft into the opening in the cranium including the step of inserting the shaft until a stop disposed along the shaft makes contact with the cranium.
 Some embodiments of the invention include more or more of the steps of extending a distal tip of the aspiration lumen out of the shaft; irrigating the region via an irrigation lumen extending through the shaft; placing a positioner above the opening and using the positioner to orient the shaft; and imaging the region to determine a target point and using a positioner to position the tool directly over the target point. BRIEF DESCRIPTION OF THE DRA WINGS
 The novel features of the invention are set forth with particularity in the claims that follow. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative
embodiments, in which the principles of the invention are utilized, and the accompanying drawings of which:
 FIGS. 1A and IB illustrate embodiment of a surgical tool according to this invention.
 FIG. 2 shows a side view of the tool of FIGS. 1A and IB.
 FIG. 3 illustrates a bottom view of the tool of FIGS. 1A and IB.
 FIGS. 4A and 4B illustrate an embodiment of rotation of a steering lever of the surgical tool of FIGS. 1A and IB.
 FIG. 5A shows an embodiment of a mechanism to center the distal tip of the tool with respect to the handle.
 FIG. 5B shows another embodiment of a mechanism to center the distal tip of the tool with respect to the handle.
 FIG. 5C shows an embodiment providing a user with tactile feedback regarding the centered position of the distal tip of the tool with respect to the handle.
 FIG. 6 shows a cross-sectional view of a portion of the surgical tool of FIG. 1.
 FIG. 7 illustrates a stop feature for the tool of this invention.
 FIGS. 8A-8B illustrate embodiments of caps for use with the tool of this invention.
 FIGS. 9A-C show an embodiment of a positioner for use with insertable tools, such as the tool shown in FIG. 1.
 FIGS. lOA-C show another embodiment of a positioner for use with insertable tools, such as the tool shown in FIG. 1.
 FIGS. 1 1 A-C show another embodiment of a positioner for use with insertable tools, such as the tool shown in FIG. 1.
 Described herein are embodiments of surgical tools and methods of use for aspiration of intracerebral hemorrhage. Aspiration of intracerebral hemorrhage is known, but previous systems and methods utilized separate, non-specialized tools through a working port of an endoscope. Provided herein are embodiments of a tool designed for aspiration of a clot or lesion from the brain, providing the relevant functionality in a single tool. Providing the functionality in a single tool can allow the tool to be sized appropriately for insertion through an opening in the skull and advancement to the site of the hemorrhage. Minimizing the size of the tool reduces the size of the skull opening necessary and the size of the path the tool takes to reach the treatment site, which can help reduce damage to surrounding brain tissue. Providing the functionality in a single tool can simplify the procedure for the performing physician. For example, a single tool can remove the need to insert and remove various tools through a working port of an endoscope, which can simplify and shorten the procedure. Additionally, the smaller profile of a single tool can make it easier for a physician to perform the procedure safely, as the risk to surrounding tissue is minimized.
 FIG. 1A illustrates a perspective view of an embodiment of a tool 100 for aspiration of intracerebral hemorrhage. The tool comprises a handle 102 and a shaft 104 extending distally from the handle 102. A steering lever 122 extends proximally from the handle 102. The tool comprises a suction lumen 106 and an irrigation lumen 108. A light conductor 110 (e.g., optical fiber) extending from a distal tip 1 14 of the shaft to the handle can connect to a light source (not shown). A cable or other conductor 112 extending from a CMOS sensor or other image sensor (e.g., CCD sensor) (not shown) disposed at the distal tip of the shaft to the handle transmits image information to a processor and/or display (not shown). In other embodiments, an optical fiber extending through the shaft may transmit image information from the distal tip to a processor and/or display at the proximal end of the shaft. The light source and image sensor are configured to allow illumination and visualization at the distal tip 1 14 of the shaft 104.
 The shaft 104 comprises a bend region 1 16, about which the shaft is capable of bending with respect to a longitudinal axis extending along the shaft 104. In some embodiments, the bend region comprises a material more flexible than surrounding regions. Steering wires 1 18 (shown in phantom) extending along the from connection points (shown here as threaded adjustable connectors 119) at the proximal end of the steering lever 122 down the shaft 104 to the distal tip 1 14 can be controlled to bend the distal tip 1 14 at bending region 116, as described in more detail below.
 The handle 102 is shown as having an ovular cross section, but other shapes (e.g., circular, square, rectangular) are also possible. An ovular cross section can allow a clinician to comfortably hold the handle 102 within the palm of his or her hand. The handle 102 comprises one or more suction holes 120 in fluid communication with the suction lumen 106. Covering the suction holes 120 can cause suction to be applied to a suction inlet positioned at or near the distal tip 1 14 of the shaft 104.
 The suction lumen 106 can extend through the handle 102 and steering lever 122 and extend from a proximal end of the steering lever 122, as shown in FIGS. 1A and B. In other embodiments, the suction lumen can extend from a more distal portion of the tool, such as along the handle 102 or a more distal portion of the steering lever 122. The suction lumen 106 can be configured to connect to a suction source, such as a wall vacuum or a portable pump.
 The irrigation lumen 108 can extend out of a proximal end of the handle, as shown in FIG. 1 A. In other embodiments, it can extend from a different portion of the tool, such as a more distal portion of the handle 102 or at a proximal end of the steering lever 122. The irrigation lumen 108 can be connected to any fluid source (not shown). For example, the irrigation lumen 108 can be connected to an intravenous fluid (e.g., saline) bag. Other fluid sources are also possible (e.g., water pump, needle, air, air pump, etc.). During evacuation of a clot, it can be important to keep the cavity around the clot open, as collapse can lead to incomplete retrieval of the clot. Irrigation can help to keep the cavity open. In some embodiments, the irrigation lumen 108 can be used to deliver drugs, biologies or other therapeutic agents (e.g., tPA, urokinase for thrombolysis, local hemostatic agents, anti-edema therapy, neural repair therapy) to the clot site. In some embodiments, the irrigation lumen 108 can be used to deliver a cooling fluid. For example, the irrigation lumen 108 can be connected to an IV bag and used to deliver saline to the treatment site.
 In some embodiments, the camera to which one of the light conductors connects can be a CMOS camera. For example, a 1 mm CMOS camera can be used. The camera can be connected to a an external computer or monitor (e.g., laptop, tablet, smartphone, TV, etc.). The transmitted image can be used to determine how and where to apply suction and irrigation during treatment of a hemorrhage.
 In some embodiments, the light source transmits light to the distal end of the shaft via an optical fiber. Various light sources are possible, such as, for example, LEDs, flint glass, and fluorescence. The light source can be used to illuminate the treatment site, allowing a better video image to be transmitted to the user.
 FIG. IB shows the same view as FIG. 1A, but shows the suction lumen 106 telescoping distally out of the distal tip 114 of the shaft 104. This feature will be described in more detail below.
 FIG. 2 illustrates a side view of the surgical tool 100. This view illustrates the handle 102, shaft 104, and steering lever 122. The steering lever 122 is attached (e.g., hingedly attached) such that it can be rotated about a proximal end of the handle 102. Hinge 202, about which steering lever 122 rotates, is shown in FIG. 2. As noted above and described in further detail below, steering wires 118 translate the movement of the steering lever to the distal tip of the shaft 104.
 FIG. 3 illustrates a bottom view of the surgical tool 100. Flanges 302 of handle 102 extend proximally to be positioned around and adjacent to flanges 304 of steering lever 122, and pin 306 extends through apertures in flanges 302, 304, to form hinge 202 connecting the steering lever 122 to the handle 102. Other connection mechanisms allowing rotation of steering lever 122 around the handle 102 are also possible.
 The suction lumen 106 is configured to telescope distally from the tip of the shaft 104, as shown by the arrows in FIG. 3. FIGS. 3 and 9 show the suction lumen 106 in a distally extended position, with the suction inlet 308 extending beyond the distal tip of the shaft 104. The suction lumen 106 can be telescoped distally by pushing on the proximal end of the suction lumen 106. In some embodiments, the handle 102 comprises a slider mechanism that can be used to push the suction lumen 106 distally and retract the suction lumen 106 proximally from its extended position. Distal extension of the suction lumen can allow maneuvering of the suction inlet 308 into tighter spaces, nooks, and crannies within a treatment site cavity.
 FIGS. 4A and 4B illustrate side views of surgical tool 100 with the steering lever 122 rotated about the hinge 202 with respect to handle 102. Movement of the steering lever 122 with respect handle 102 tensions one of the steering wires 1 18 and slackens the other steering wire 1 18 translate the rotation of the steering lever 122 with respect to the handle 102 and the shaft 104 into bending of the distal tip 1 14 with respect to the shaft 104 at the bending region 1 16. The tip can be configured to bend up to about 45° in two opposite directions from a longitudinal axis of the shaft, providing a total range of about 90°. Other ranges are also possible. For example in some embodiments, the tip can be configured to bend up to about 90° from a longitudinal axis of the shaft, providing a total range of about 180°. In FIG. 4A, counterclockwise rotation of the steering lever 122 around the proximal end 124 of the handle 102 causes counter-clockwise rotation of the distal tip 1 14 of the shaft 104 about the shaft axis, as shown by the arrows in FIG. 4A. As shown in FIG. 4B, clockwise rotation of the steering lever 122 around the proximal end 124 of the handle 102 causes clockwise rotation of the distal tip 1 14 about the shaft axis.
 In other embodiments, counter-clockwise rotation of the steering lever 122 can cause corresponding clockwise rotation of the distal tip 114 about the shaft axis, and clockwise rotation of the steering lever about the proximal end 124 of the handle 102 causes counter-clockwise rotation of the distal tip 1 14 about the shaft axis, in a manner known in the art. A ratio of the rotation of the steering lever 122 to corresponding rotation of the distal tip 114 (e.g., a ratio of angle a to angle β can be adjustable in some embodiments. The ratio can be, e.g., about 0.5-3. In some embodiments, tension on the steering wires 1 18 can be modified to adjust this ratio. The tension can be adjusted using adjustable threaded connectors 1 19 (e.g., screws)positioned at the proximal end of the handle 102. Increasing the tension can decrease the ratio of steering lever rotation required for corresponding distal tip rotation. Decreasing the tension can increase the ratio of steering lever rotation required for corresponding distal tip rotation. Other mechanisms for adjusting the tension are also possible. For example, it is also possible to change the location of hinge 202 by shortening or lengthening the steering lever 122 with respect to handle 102. The steering lever 122 can move approximately 180° around the proximal end 124 of the handle 102. Through rotation of the tool, 360° of tip articulation is possible.
 In some embodiments, the tool 100 may be configured to facilitate centering of the distal tip 1 14 of the shaft 104 such that the distal tip 114 is aligned with a longitudinal axis of the shaft. Ensuring centering of the distal tip 1 14 during insertion of the distal tip 1 14 into brain tissue can help to minimize trauma to surrounding brain tissue. For example, if the distal tip 1 14 were inserted into brain tissue at an angle, the portion of the distal tip 1 14 moving through brain tissue would have a greater surface area, causing greater trauma to the brain tissue.
 In some embodiments, the centering of the distal tip 114 can be facilitated by biasing the distal tip to a centered position. For example, a torsional spring 308 can be positioned between the handle 102 and the steering lever 122 at the pivot point 202, as shown in FIG. 5 A. The torsional spring can cause the handle 102 and the steering lever 122 to be aligned along a longitudinal axis of the handle 102 when no external steering force is applied to move steering lever 122 with respect to handle 102. In FIG. 5B, a pair of helical springs 308a extending into handle 102 from hinge 202 are both in their least extended positions when handle 102 is aligned with steering lever 122 so that each spring 308a will pull the handle 102 into alignment with steering lever 122 when no external force is applied to move steering lever 122 with respect to handle 102.
 In some embodiments, the centering of the distal tip 1 14 can be facilitated by providing the user tactile feedback indicating a centered position of the distal tip 1 14. The handle flanges 302 and the steering lever flanges 304 can comprise features configured to interact with one another to indicate a centered position of the distal tip 114. For example, one (or both) of the steering level flanges 304 can have a bump or protrusion 314 configured to interact with a detent 312 on one (or both) of the handle flanges 302, as shown in FIG. 5C. The bump and detent or other indicating feature are positioned so that they interact when a longitudinal axis of the steering lever 122 and handle 102 are aligned.
 A clinician using the tool 100 can hold the handle 102 with one hand and place the other hand on the steering lever 122 to control bending of the distal tip 1 14 of the shaft 104. Using a hand to manipulate the steering lever 122 can provide tactile feedback of the movement of the distal tip 1 14, which can provide a user with greater control over the bending of the distal tip 1 14.  FIG. 6 provides a cross-sectional view of the shaft 104 taken along the 6-6 line shown in FIG. 3. The shaft 104 comprises a wall 602 defining a lumen 604. Within the lumen 604 are positioned the suction lumen 106, irrigation lumen 108, light source light conductor 110, and image sensor conductor 1 12. The shaft 104 can be sized such that there is not much extra space between the inner wires and lumens and the wall. Minimizing the size of the shaft in this manner can minimize trauma to surrounding brain tissue, as described above. In some embodiments, an outer diameter of the shaft is about 10-20 mm. In some embodiments, an outer diameter of the shaft is about 12-18 mm. In some embodiments, an outer diameter of the shaft is about 13-17 mm. In some embodiments the outer diameter is about 14-16 mm. In some embodiments, an outer diameter of the shaft is less than about 15 mm. Other outer diameters are also possible.
 In some embodiments, the surgical tool has a stop feature configured to prevent over- insertion of the shaft into the treatment area, which can minimize trauma to surrounding brain tissue. The stop feature can include an element positioned along the shaft and having a greater cross sectional area than the shaft and of the skull opening through which the shaft is inserted. The portion of the stop extending around the shaft can be configured to rest on the skull and can interact with the handle and/or shaft to prevent the shaft from being inserted into the patient's brain farther than an intended depth. The stop element can have a variety of shapes as long as the shape engages with the skull adjacent the opening to limit movement of the shaft into the patient's brain. For example, the stop element surrounding the shaft can have a cylindrical shape, ring shape, a spherical shape, and ovular shape, a plurality of protruding members, etc.
 One embodiment of the stop feature is shown in FIG. 7. A depth controller 802 extends distally from handle 102 surrounding shaft 104. Depth controller 802 has an outer diameter larger than the diameter of the opening 808 in skull 810. Shaft 104 extends beyond the distal end of depth controller 802 a sufficient distal to place the distal end 1 14 of shaft 104 in the desired treatment region 812 when the distal end of depth controller 104 engages the patient's skull 810 around opening 808. In some embodiments, the depth controller can be part of the handle, and in some embodiments, the depth controller can be replaced with another depth controller having a different length (e.g., 12 cm or 10 cm or 5 cm). In some embodiments, the length of the depth controller may be chosen as needed to limit the depth the distal end 114 of the shaft 104 extends into the patient's brain. For example, the length of the depth controller can be chosen so that distal end 1 14 of the shaft 104 can extend beyond the distal end of the depth controller 802 by 8 cm, or by 10 cm, or by 15 cm.
 In some embodiments, the stop feature also includes an elastic element. As shown in FIG. 7, an elastic element 804 (e.g., a spring) is disposed on the distal end of the depth controller 802. Like the depth controller 802, the elastic element 804 has an outer diameter greater than the diameter of the opening 808 in skull 810. Elastic element 804 functions as an extension of depth controller 802. Engagement of the elastic element 804 with the patient's skull 810 around opening 808 provides tactile feedback to the user and helps offset the weight of the tool during the shaft's advancement into the patient's brain, making it easier for a clinician to make fine movements of the shaft and improving the overall ergonomic feel of the tool. Distal movement of the shaft 104 can continue after initial engagement of the elastic element 804 with the skull 810 until the elastic element 804 is fully compressed, at which point the elastic element stops further distal movement of the shaft 104. In some embodiments, the elastic element compresses e.g., from a length of 4 cm to a length of 1 cm, and the distal end 114 of shaft 104 can extend beyond the compressed length of elastic element 804 by, e.g., 7 cm or 9 cm or 14 cm. In some embodiments, the difference between the expanded and compressed lengths of elastic element 804 is 3 cm. Other configurations are also possible. For example, the elastic element can comprise a rubber element or a sponge.
 As shown in FIGS. 8A and B, in some embodiments, a cap 904 extends from the distal end of shaft 104. The cap 904 can be formed integrally with the distal end or it can be attached to the distal end. The cap 904 can have a fern-like shape (FIG. 8A) or a mushroom shape (FIG. 8B). The distal tip of the shaft 104 is shown positioned within the clot 908. The cap 904 can rest against brain tissue 910 adjacent the clot 908 and can help to prevent over-insertion of the shaft 104 into the brain tissue 910.
 The surgical tool 100 of this invention can be used as follows. Imaging (e.g., ultrasound, X-ray, CT, or MRI) can be used to determine the position of the clot or lesion. A craniotomy can be performed to create a hole in the skull directly over the region of the tissue (e.g., clot) or at a known position relative to the tissue. The position of the hole relative to the clot allows the shaft 104 or the surgical tool 100 to be inserted directly into the hole without needing to be turned or angled within the brain cavity. The access hole can be just wide enough for the shaft 104 to be inserted at the correct angle. The device's shaft is inserted into the hole in the skull and is advanced distally until the tip 114 is beyond or at a distal end of the clot. A light source is connected to its corresponding optical fibers 1 10, and the CMOS, CCD or other image sensor (not shown) transmits illuminated images to the processor and/or display on the proximal end (not shown) to visualize the area. The clot is aspirated through lumen 106, beginning at the distal end of the clot. Aspiration is continued as the device tip is retracted. The device tip 1 14 can be articulated and rotated to ensure complete removal of the clot. Irrigation via lumen 108 can be used to deliver drugs or keep the cavity open to help ensure complete removal of the clot.  In another embodiment, an LED or other light is disposed at the distal end of the device. In this embodiment, a conductor extends from the LED and is connectable at its proximal end to a power source to provide power to the LED.
 In yet another embodiment, an optical fiber extending from the distal end of the shaft can conduct images proximally from the distal tip. In such embodiments, the optical fiber is connectable to a display at its proximal end.
 FIGS. 9A-C illustrate an embodiment of a positioner 1010 that can be used with tool 1000. In some embodiments, the tool 1000 can be similar to tool 100. In other embodiments, the tool 1000 is a different tool configured for insertion into the body. FIG. 9A shows a side view of positioner 1010 positioned over a hole 1080 of an object 1082 (e.g., a skull) with tool 1000 extending through an opening 1040 in the positioner 1010 and thereby through hole 1080. The positioner 1010 has an outer element 101 1 and an inner element 1012. The outer element 1011 has a top surface 1013 and a bottom surface 1014. An annular flange disposed between the top and bottom surface has a diameter wider than the diameter of hole 1080 and an underside surface 1015 adapted to rest against the object 1082. The portion of the outer element below the flange has a surface 1009 adapted to extend into hole 1080 between surface 1015 and surface 1014. The inner element 1012 of the positioner is disposed within the outer element in an adjustable relative orientation. In the illustrated embodiment, inner element 1012 has a partially spherical outer surface that slidably mates with a corresponding curved surface in outer element 101 1 to permit rotation and tilting of the inner element with respect to the outer element. The relative orientation between the inner and outer elements can be indicated by indicators 1016 on the positioner or on the object that the positioner is placed on, as shown in the top view of FIG. 10B and the side view of FIG. IOC. Reference marks 1037 on tool 1000 may also be used to indicate depth of insertion of tool 1000 into opening 1040.
 Using the positioner 1010, the tool 1000 or tubing or a distal end of the tool 1000 or tubing can be placed at a desired location and orientation within the object 1082. The placement of the positioner 1010 and the tool 1000 according to the reference marks 1037 and/or 1016 allows access to a specific location at the distal end of the tool 1000 or tubing related to the object 1082 or hole 1080. The placement of the tool, and the desired relative positions of reference marks 1016 and/or 1037, can be planned by estimations from the user, images (such as CT, MRI, X-ray, Ultrasound image, PET, etc.), or simulations.
 FIGS. lOA-C illustrate another embodiment of a positioner 1050. The positioner 1050 has a top surface 1052, a bottom surface 1054 and a side surface 1014a. An annular flange disposed between the top and bottom surface has a diameter wider than the diameter of hole 1080 and an underside surface 1056 adapted to rest against the object 1082. The portion of the outer element below the flange has a surface 1058 adapted to extend into hole 1080 between surface 1052 and surface 1054. The relative distances between surfaces 1056 and 1054 can be set with desired dimensions to allow proper placement of the positioner on and related to an object, such as placing the positioner securely in a hole through a human skull, without the bottom surface 1054 interfering with the dura or brain. In other embodiments, the positioner can be used in/on a nose hole, in/on an ear hole, or in/on a navel.
 As shown in FIG. 10A, the top surface 1052 of the positioner can have marks 1060 indicating distance or orientation. The top surface of the positioner can be made from materials and with a thickness allowing the leading edge 1062 of a tool 1064 (similar to tool 100) to punch through at a desired angle and orientation into a cavity 1066 to set the tubing in a desired location and orientation in a 3D space related to the object 1082. For example, the top surface can be, e.g., a plastic sheet, tape (e.g., medical tape), a rubber, or a gel. The thickness of the top surface can be about 1-2 mm. The cavity 1066 has an opening at its bottom with a diameter about the size of the tool 1064. The cavity near the top surface is wider than the opening at the bottom, which allows the tool to be set in a desired location and orientation. For example, the tool 1064 can be positioned at an inclined orientation angle P of 0° - 30°), as shown in FIG. IOC.
 FIGS. 1 1 A-C illustrate a method for positioning a tool (e.g., tool 100) over a treatment site. The treatment site 1 100 can be imaged, for example, using CT, MRI, or X-ray. As shown in FIG. 1 1 A, the resulting image is then used to identify landmarks 1 102 and to establish a coordinate system 1 103 that could describe any given location and orientation on or around the object 1 104 (e.g., the skull). Imaging can also be used to determine the target or treatment site
1 100 (FIG. 1 1C) and target point 1 101 (e.g., location of the clot or lesion). The target point 1 101 can be the centroid of the target area 1 100 or can be any given point within the target area.
Coordinates of the target 1101 point based on the coordinate system describe above are calculated.
 The access point 1 106 on the object 1104 (e.g., the skull) is determined (e.g., by the operating physician, a clinician, given data), and a straight line 1 1 10 connecting the target point
1101 and the access point 1 106 is determined.
 As shown in FIG. 1 IB, positioner 1 130 has a skin retractor, a top support 1 138, and a bottom support 1 140. The skin retractor comprises two legs 1 132, 1 134 and an adjuster 1136 (e.g., a spring or other elastic mechanism). The skin retractor is connected to the top support 1 138 such that an angle between the legs 1 132, 1 134 is adjustable. The adjustment mechanism 1 136 connects the legs. The bottom support 1 140 is attached to the bottoms of each leg using a connector 1142. The length of the connectors 1142 is adjustable to accommodate varying distances and angles between the legs 1 132, 1 134. The length of at least one of the legs 1 132, 1 134 and/or the length of the top support 1 138 can be adjusted to provide desired relative positions between the top support 1 138 and the bottom support 1140.
 The top support 1 138 has a through hole 1144, and the bottom support 1 140 comprises a through hole 1 146. The through holes 1 144, 1 146 can be aligned during use of the positioner. A tool or device 1150 (e.g., a drill, an endoscope, a suction device, a tube, a guide wire, a sheath, an ultrasound probe, a light source, an irrigating source) can be inserted so that it passes through both through holes.
 The positioner 1 130 can be placed at a desired location on an object 1104 (e.g., the skull) and can be adjusted to a desired configuration according to the coordinates defined by the landmarks 1 102 and the relative location of the target point 1 101, as shown in FIG. 1 1C. The bottom support through hole and the top support through hole can be aligned with the straight line 1 1 10 connecting the target point 1101 and the access point 1 106, to allow positioning and operating a tool or a device.
 Variations and modifications of the devices and methods disclosed herein will be readily apparent to persons skilled in the art. As such, it should be understood that the foregoing detailed description and the accompanying illustrations, are made for purposes of clarity and
understanding, and are not intended to limit the scope of the invention, which is defined by the claims appended hereto. Any feature described in any one embodiment described herein can be combined with any other feature of any of the other embodiment whether preferred or not.
 It is understood that the examples and embodiments described herein are for illustrative purposes only and that various modifications or changes in light thereof will be suggested to persons skilled in the art and are to be included within the spirit and purview of this application and scope of the appended claims. All publications, patents, and patent applications cited herein are hereby incorporated by reference for all purposes.
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|Clasificación internacional||A61B17/22, A61M25/14, A61B17/221|
|Clasificación cooperativa||A61B2090/306, A61B1/0051, A61B1/0669, A61B1/05, A61B2090/3614, A61B2017/00327, A61B2090/103, A61B2090/036, A61B2217/007, A61B2017/22079, A61B2217/005, A61B90/11, A61B17/22|
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