Device and method to cool brain and to diagnose and treat glioblastoma

Abstract

To provide a method, and apparatus used to prevent brain death by use of rapid and safe cooling of the brain.SOLUTION: A cisterna magna is accessed through a patient's neck and cooled artificial cerebrospinal fluid (aCSF) is circulated about spaces within the brain and in a subarachnoid space surrounding the brain by entering a cisterna magna 1 with an entry through the neck of the patient with a specially designed needle / cannula 3 which allows the flow of cooled aCSF about the brain. The aCSF exits from an opening in the skull where a temperature / pressure sensor is placed. Data is sent to a computer-controlled motorized system that feeds, by a pump 8, cooled aCSF to the needle / cannula placed in the cisterna magna. The pumping of aCSF is controlled to maintain a predetermined temperature and / or pressure of the exiting aCSF.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] Related Applications This application claims priority based on U.S. Provisional Patent Application No. 62 / 905,996, filed on September 25, 2019, which is incorporated herein by reference in its entirety pursuant to 35 USC 119.

Background Art

[0002] The illustrated embodiments are directed to a unique method for safely and rapidly cooling the brain to ultra-low temperatures (20 - 25°C using aCSF cooled to 1 - 10°C) for the prevention of brain death in cases of insufficient blood circulation to the brain, including diseases such as myocardial infarction, stroke, and cardiac arrest due to hemorrhage.

[0003] Description of the Prior Art Fifty years ago, Professor Robert White demonstrated that when he tied off all the major blood vessels in the neck of a monkey and cooled the monkey's brain to 15°C, the structure and function of the brain were protected without blood circulation to the brain for 1 hour. After 1 hour, the ligature wire wrapped around all the blood vessels in the neck was loosened, and the monkey was given time to return to room temperature. Subsequent tests showed no decline in memory, problem-solving, and motor activity.

[0004] Professor White's new research is currently being successfully used by thoracic surgeons who repair the aortic arch with an aortic prosthesis, such as in the case of Marfan syndrome with aortic dissection, as shown in Figure 4. Cooling the brain to 10°C allows for a 30-minute surgical time with little or no blood flow to the brain. By sending extremely cold saline into the subclavian artery, this temperature can be reached within the brain. This has been very successful and can prevent brain damage without loss of memory or function. Figure 4 emphasizes the importance of knowing a wide range of medical literature outside of neurology and neurosurgery. In 1975, Griepp et al. first reported in the cardiac thoracic literature after lowering the temperature of the brain to the range of ultra-low body temperature using cardiopulmonary bypass. Griepp et al. succeeded in maintaining brain function despite cardiac arrest in patients using aortic arch replacement. In such surgeries, it is common medical practice to include ultra-low body temperature therapy to put the brain in a "suspended animation" state for more than 30 minutes during which no blood flows to the brain.

[0005] By lowering the temperature of the brain to extreme hypothermia, it is possible to put the brain in a state of suspended animation despite the absence of blood flow. In The Lancet (355(9201)375 - 376), 29-year-old radiologist Anna Bagenholm was reported to have been frozen to 13.7°C in a submersion accident and her electrocardiogram was flat. After being resuscitated and returning to normal body temperature, she fully regained all her intellectual abilities. Samuel Tisherman, MD, who receives funding from the Department of Defense, reported in November 2019 that he treated patients with severe trauma by cooling the brain to extreme hypothermia using refrigerated saline in the cerebrovascular circulation. After two hours of hypothermia, he was able to complete surgical repair and resuscitate the patients.

[0006] Children who have fallen through the ice on a frozen lake and been submerged in extremely cold water for over an hour have been reported to survive without apparent brain damage. The child may have had an open fontanelle and a thinner skull, allowing for rapid brain cooling, so adults in similar harsh circumstances cannot survive the freezing water. Today, infants and children at risk of ischemic brain injury are treated with mild to moderate hypothermia, and compared to children whose whole body temperature is not lowered, their survival rate is improved and they have less brain damage.

[0007] Many reports have studied the use of mild to moderate hypothermia, in which the body temperature is only lowered to 33°C, in the case of a heart attack, and various successful reports have been made in the results analysis. Lowering the body temperature below 33°C can cause arrhythmias due to adverse effects on the ventricles and bleeding problems caused by the interruption of platelet aggregation leading to bleeding.

[0008] In the case of a blockage of blood to the brain, irreversible brain damage can occur in just a few minutes. Cardiopulmonary resuscitation (CPR) is the standard treatment for cardiac arrest, but even if successful, it can cause a stroke in brain tissue with serious disabilities. In addition to cardiac arrest, major strokes and bleeding are major life-threatening problems that need to be treated within the first few minutes of the lack of circulation to the brain. It is not surprising that the military is eager to find a way to extend brain survival for over an hour using circulatory arrest. This search for a way to extend this "golden hour" gives the treating physician a chance to address the pressing problems and their causes. If the brain can be put into a state of suspended animation for over an hour, it will lead to a paradigm shift in the medical treatment of patients at risk of sudden brain death. If the brain can be protected from ischemic damage by rapidly and effectively using ultra-low body temperature, the restoration of circulation and the repair of damaged organs and tissues will be possible. By being given one hour instead of just five minutes, the treating physician has a chance to save the patient. Summary of the Invention

[0009] In the range of profound hypothermia (<14°C), such hypothermia can be achieved using the technique of cooling the brain with artificial cerebrospinal fluid (aCSF). Although it is the subject of clinical improvement, for the purposes of this patent, the target temperature range of "ultra" hypothermia is used according to the surgical technique of "deep hypothermic circulatory arrest" (DHCA). A review of the history, current research, and theoretical basis for this paradigm shift in the approach to ultra-hypothermia of the brain is presented.

[0010] The illustrated embodiments of the present invention provide devices and methods for preventing brain death caused by cardiac arrest, stroke, blood loss due to hemorrhage, and interruption of intracranial circulation to the brain due to other causes. By selectively cooling the brain, the brain can be put into a "suspended animation" state for more than one hour without circulating blood flow. Instead of just five minutes to save a patient on the verge of brain death, the treating physician has more than one hour of leeway to save the patient's life. By directly cooling the cerebrospinal fluid, the brain can be cooled without directly entering the cerebral vascular circulation by inserting a cannula into the aorta or large blood vessels to the brain. The time required to insert a cannula into the circulation makes it difficult to do so quickly, and the problems of whole-body cooling can cause arrhythmias and bleeding.

[0011] Therefore, a new approach is needed for the paradigm shift in the rapid cooling of the brain. The device of the illustrated embodiment is required to enter the large tank safely, accurately, and quickly without trauma. Since the first person who may be able to insert a needle into the brain may be a paramedic, the procedure must be accessible to anyone, easy to use, and quickly implemented. After being placed in the desired position, the needle needs to be fixed to a stationary anatomical site, and the shape of the sharp cutting tip of the needle needs to be changed to prevent damage to the large tank and the brain tissue of the brainstem. In the case of battlefield situations, the design of a similar needle system that can be inserted into large blood vessels such as the femoral artery needs to be safe and quickly executable when used by a paramedic.

[0012] Method of cooling the brain through a large tank In an emergency situation dealing with a patient who has suffered a sudden interruption of blood circulation to the brain leading to brain death, the features of the illustrated embodiments for rapidly preventing brain death are safety, accuracy, and speed. Clinically, the brain can be put into a suspended animation state during surgery to replace a dissecting aortic aneurysm by pumping cold saline into the brain via a bypass to the subclavian artery. This has been very successful worldwide in humans.

[0013] Research in our laboratory demonstrates that the brains of experimental animals can be rapidly cooled to ultra-low body temperature, or even lower, profound hypothermia. Rapidly cooling cerebrospinal fluid (CSF) by circulating cooled artificial cerebrospinal fluid (aCSF) around the brain targets not only the brain within the subarachnoid space but also the blood vessels within the basal cisterns, cooling the central nervous system (CNS). It was found that rapid and safe access to the subarachnoid space can be achieved by entering the cistern magna from the occipital-atlantal junction posteriorly or via a lateral route below the mastoid bone. Since the needle entering is in close proximity to the brainstem and vertebral arteries, this needs to be done under direct visualization using ultrasound passing through the needle and its surrounding direction. An outlet located on the forehead (near the hairline) is required to drain aCSF from the head and to enable convective cooling. This outlet is a new design of a trephine that is rapidly inserted, stable, safe from damage to the brain, accurately positioned, and semi-automatically performed by one human. The fluid emerging near the frontal lobe of a supine patient is warmer, with a temperature difference from the colder fluid closer to the posterior of the head. The subarachnoid space is relatively large in elderly patients, and the greater the amount of aCSF, the higher the cooling effect.

[0014] Another configuration enables the aCSF to be recycled from the trephine and into the large tank. To recycle the aCSF, the outlet opening is connected to a sterile drainage system or a pump system that is controlled via information from additional tubes for temperature and pressure measurement. The temperature of the exiting aCSF and the temperature upon entering the large tank are monitored. The cooling system is integrated with a refrigeration unit and a peristaltic pump. When a closed system is used, a filter system is connected in series with this closed system to remove debris, contaminants, and infectious agents from the path from the front part of the brain where the fluid is drained. This generates convective cooling, which rapidly improves brain cooling. The virtual "pump" created by convective cooling functions as an additional "motor" within the skull, facilitating rapid cooling.

[0015] Virtually, the recirculating cooled aCSF exists within a closed sterile system that cools the large tank and brain structures within the subarachnoid space. Initial cooling is provided to the blood vessels at the base of the brain, from which it is provided via the cooled blood circulating through the brain tissue. The cooled aCSF directly cools the base of the brain and important structures including the memory section. From there, the cooled aCSF passes around the brain within the subarachnoid space. In the supine position, there is a temperature difference between the cold fluid near the back of the head and the warm liquid at the front of the brain where the fluid exits, thereby causing convective cooling and rapid, improved cooling of the brain. The virtual pump created by convective cooling functions as an additional pump within the skull, facilitating rapid cooling.

[0016] For grammatical smoothness, the devices and methods have been, or will be, described using functional descriptions, but the claims should not be construed as necessarily being limited by an interpretation of "means" or "step" limitations, unless the claims are explicitly formulated based on 35 USC 112. Instead, the meaning of the definitions provided by the claims and the full scope of equivalents should be given based on the doctrine of judicial equivalents. When the claims are explicitly formulated based on 35 USC 112, the statutory full equivalents based on 35 USC 112 should be given. The present disclosure can be better visualized by referring to the following drawings, in which like elements are represented by like numerals. BRIEF DESCRIPTION OF THE DRAWINGS

[0017]

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[0018] The present disclosure and its various embodiments can be better understood by referring to the following detailed description of the preferred embodiments presented as illustrative examples of the embodiments defined in the claims. It is clearly understood that the embodiments defined by the claims may be broader than the illustrated embodiments described below. **Mode for Carrying Out the Invention**

[0019] Animal experiments: Previous attempts to cool the brain via lumbar puncture were ineffective, so the cistern located at the base of the brain was selected as the entry point for the cooling device. Entering through the spinal canal, the temperature of the aCSF increased due to the warmth of the circulating blood vessels within the spinal canal. Entering the cistern, the largest of the cerebrospinal fluid-containing spaces, a 17-gauge needle can be placed into the subarachnoid space and cooled saline can be circulated through an outlet on the forehead. Initial experiments on over 50 recently deceased pigs conducted using this methodology yielded promising results and were encouraging for in vivo testing.

[0020] To test in vivo, and thus to monitor tissue temperature and, accordingly, the effect of circulating cooled aCSF as shown in the CT scan of FIG. 24, thermistors were placed at various depths (in 5 mm increments) within the brain in combination with our approach. Brain temperatures collected during the in vivo experiment demonstrated that the brain could be cooled within a large animal model under general anesthesia with warm blood flowing into the brain. Further, after euthanizing the sample with Euthasol at 15:35, the temperature of the brain was monitored with no blood flow. The graph of FIG. 25 shows that the brain is further cooled when the inflow of warm blood from the heart ceases. These results are consistent with the hypothesis that it is essential to account for the warm gradient of the inflowing blood when attempting to cool the brain with cooled aCSF. FIG. 25 is a graph of data collected from four implanted thermistors that monitored the brain temperature of a pig model under general anesthesia and under the methodology we propose to induce hypothermia. Each thermistor was placed within the cortex at four different depths of the brain from the surface in 5 mm increments. The horizontal bars indicate the pump rate in mL / min. The temperature drops to 15° C. within the first 10 minutes. After euthanizing the sample at 15:35, the temperature continued to drop until the experiment ended.

[0021] Conversely, this revolutionary system is designed for extreme emergency situations, specifically for patients who have experienced shock or have little or no blood flow to the brain. By minimizing heat from the circulating blood, brain cooling is made easier, and the time for intervention is maximized, making these cases more advantageous.

[0022] The results of our in vivo studies support our approach of cooling the brain by directly cooling the CSF and enhancing the cooling effect in the subarachnoid space adjacent to the cortex where neurons are located by convective cooling. Furthermore, since the flow of CSF from the cisterns begins at the base of the brain, the memory circuits are cooled early. Since the vertebral basilar artery circulation is adjacent to the cisterns, the circulating blood is cooled without inserting a cannula into the blood vessels, and the deep structures are further cooled.

[0023] As shown in FIG. 1, the effectiveness of the cooling system was demonstrated in experiments on living animals. The most important point is that after inserting the needle, it is necessary to fix it immediately to prevent the ultrasonic needle 3 from changing its position outside the large tank 1. The aCSF is refrigerated to a temperature within the range of 1 to 10 °C in the cooler 7 and is carried by the pump 8 through the filter 9 to the needle 3 in the large tank 1. The flow of the cooled aCSF throughout the subarachnoid space 2 is very effective in cooling the brain at several levels, especially on the cortical surface where the more vulnerable neurons of the gray matter are present. In elderly adult patients, as the brain naturally shrinks with age, the volume of the subarachnoid space 2 becomes larger. As a result, the amount of aCSF in circulation increases, and the brain is more rapidly exposed to the cooling effect. The cooled aCSF in the large tank 1 is close to the circulation of the basilar artery and the circle of Willis of the cerebral artery. This brings an additional cooling effect to the central structure, especially the areas of the brain that are useful for memory. It should be noted that the cooling system may initially be chemical cooling, which is a simpler and more effective method in emergencies. Also, if the treatment is not necessarily to cool the brain but to change the temperature to a warmer state, a cooler and / or a heater may be used in a similar system to set the cleaning liquid to an appropriate temperature. The thermistor is provided to monitor the temperature in the subarachnoid space 2 at the outlet of the aCSF 5 in the skull through the trephine 4 and at the inlet of the large tank 1. The intracranial pressure gauge monitors the intracranial pressure.

[0024] The disclosed apparatus and method provide an effective and safe way to rapidly cool the brain by using hypothermia to prevent brain death. The needle 3 is safely, rapidly, and accurately placed in the large tank 1 to circulate cold artificial cerebrospinal fluid (or other isotonic fluid) within the skull and in the subarachnoid space 2. By lowering the temperature of the artificial cerebrospinal fluid (aCSF) and circulating it around the blood vessels in the subarachnoid cistern, the circulation of the brain is cooled. When the cooled aCSF reaches the subarachnoid space 2, especially behind the brain, by a computer-controlled peristaltic pump, convective cooling begins because warmer fluid exits through the frontal bone to discharge the warmer fluid. Then, as shown in FIG. 1, the exiting aCSF is aseptically collected.

[0025] Alternatively, as shown in FIG. 2, it is cooled and filtered outside the body and recirculated back to the inserted needle 3, which is fixedly disposed within the large tank 1. In FIG. 2, for the recycling of aCSF 10 from the skull exit port to the pump, a filtration system 9 is required to remove infectious pathogens and debris from the aCSF before it re-enters the large tank 1. Recycling the aCSF 10 in a sterile environment has many advantages, such as being easier to maintain a sterile environment, more effective cooling, less aCSF required to carry in an emergency, and potential efficiency in space and supply. The inserted needle 3 is fixed in a stable structure as described in FIGS. 12 and 13 of the head and neck to prevent movement of the needle tip within the large tank 1.

[0026] FIG. 12 shows one configuration of a method for fixing the needle tip after it enters the large tank 1 and includes the use of an exoskeleton 24 disposed across the posterior head and neck to provide fixation, stability, and accuracy for the proper insertion of the ultrasonic needle 1 into the large tank. The mastoid bone and / or the external auditory canal serve as the posterior fixation point, and the trephine screw within the frontal bone serves as the anterior fixation point. A "skull cap" fits like the exoskeleton 24 to provide fixation and stability to the ultrasonic needle.

[0027] FIG. 13 represents a second embodiment for fixing the needle after it enters the large tank 1. The second embodiment includes the use of a firm band that wraps around the upper cervical vertebrae without causing pressure damage to the ear and is disposed around the forehead where the trephine firmly screwed into the frontal bone 25 is located. The external auditory canal functions as a reference point for properly positioning the band. This stably fixes the needle when it enters the large tank 1. Further, when using a servomotor system to semi-autonomously or robotically guide and move the needle within the large tank 1, a stable fixation base for guiding the needle, such as the "skull cap" exoskeleton 24 as shown in FIG. 12, is required.

[0028] This circulation of the cooled aCSF within the subarachnoid space rapidly cools the entire brain, including the structures at the base of the brain and the gray and white matter on the outer surface of the brain.

[0029] In FIG. 3, a single opening is planned in the skull to drain circulating aCSF from the subarachnoid space 2. When the patient is lying supine, it is optimal to orient the opening towards the frontal lobe to utilize convective cooling as shown in FIG. 8. The semi-autonomous or robotic trephine 4 with a hollow screw serves to drain the fluid of FIG. 18. Through the same opening, the temperature sensor 11 provides feedback regarding the depth of cooling, the effectiveness of cooling, and the cooling rate. A pressure sensor (not shown) is also required to prevent brain damage due to overly high pressure during aCSF administration. By knowing the temperature and flow rate of the fluid flowing into the large tank 1 and out of the outlet 4, the cooling rate and the effectiveness of cooling can be obtained. FIG. 8 illustrates the additive effect of convective cooling 13 on the pumping action of aCSF after it enters the large tank 1 and settles in the occipital region of the head of a supine patient. Convective cooling occurs because cold CSF is in the lower occipital region and relatively warm CSF is on the frontal lobe side above, and the warmer fluid is drained.

[0030] Accordingly, the disclosed apparatus and method succeed in safely and rapidly generating ultra-low body temperature of the brain. Furthermore, this method is also effective in rapidly and safely cooling the spinal cord, as shown in FIG. 6, to prevent post-traumatic spinal cord swelling or protect the spinal cord from ischemic injury. The spinal cord is cooled by directing the flow of cooled aCSF from the large tank 1 through the lumbar puncture needle 14 to the lumbar region.

[0031] Cardiac arrest, stroke, and hemorrhage can cause brain death within 5 minutes unless the brain can be rapidly induced into a suspended animation state. Rapidly inducing the brain into a suspended animation state gives the physician up to more than one hour to perform treatment to save the patient's life, and the disclosed apparatus and method provide this.

[0032] The disclosed device includes an ultrasonic guide needle 3 as described in FIGS. 9 and 10, comprising a plurality of elements configured to provide a three-dimensional ultrasonic image in front of the penetrating needle. Since the image and ultrasonic feedback are displayed on a video monitor of a size similar to that of a mobile phone, the paramedic can quickly and safely enter the cranial vault 1 of the brain. Further, in order to change the shape, prevent the cutting of brain tissue, and facilitate a gentle flow of aCSF through the needle 3, a shape memory alloy is included at the tip of the needle 3 as shown in FIG. 11. The similarly designed needle 3 facilitates semi-autonomous penetration into arteries and other blood vessels in the body, such as the femoral artery, when rapid and safe penetration is required in an emergency.

[0033] To prevent brain death by rapidly cooling the brain using hypothermia, it is important to design the needle 3 to be safely, rapidly, and accurately placed within the cranial vault 1 in order to circulate cooled artificial cerebrospinal fluid or other isotonic fluid within the cranial cavity and the subarachnoid space 2.

[0034] FIG. 5 shows a new path from the side of the neck directly below the mastoid bone 12. Gong et al. (J Neurosurg 129:146-152, 2018) describe a Lateral Atlanto-occipital Space Puncture with a 98.3% success rate out of 1,008 punctures. This has the advantages of rapid insertion, proximity to the mastoid bone for fixation, and a high success rate of insertion. Currently, this procedure is performed by neurosurgeons and neuroradiologists using fluoroscopy, which is not always available on-site, in the emergency room, or in the operating room. Further, errors can occur under the stress of an emergency, and the sharp needle tip poses a danger to the brain during long stays in the cranial vault. Thus, there is clearly a need for a new technique for entering the cranial vault 1. This is addressed in the present disclosure.

[0035] The lateral neck area beneath the mastoid bone may be more easily found and accessed by a paramedic or nurse. As shown in Figure 5, it can be easily identified as a bony ridge behind the ear and usually does not require shaving of hair. It is a fixed stationary point and the fixation of the needle 3 can be quickly and easily performed. When the ultrasonic guide needle 3 is inserted, a directional image is displayed on a handheld unit such as a mobile phone, and visual information and acoustic information are displayed in real time as shown in Figure 9. Semi-autonomous or robotic insertions will also be described. The data obtained from the tip of the ultrasonic needle 3 directs the tip of the unit along its trajectory.

[0036] Spinal cord cooling Figure 6 shows a new approach to the treatment and / or protection of the spinal cord in cases of direct trauma, blunt injury, concussion injury, ischemic injury, blast exposure, and surgical intervention that may endanger blood circulation to the spinal cord. When cooled aCSF is fed into the large tank 1 and the flow 15 of aCSF is directed down the spinal canal, it is discharged through the lumbar puncture needle 14. Similar to cooling the brain, spinal cord cooling may be performed by pumping aCSF into the large tank 1 and discharging it into a drainage bottle. Using a pump, filter, and cooler in series to recycle aCSF and return it from the lumbar puncture needle 14 to the large tank 1 mimics the brain cooling technique. Depending on the hydrodynamics and the location on the spinal cord that needs to be cooled, cooling may be initiated through the lumbar puncture needle 14 and discharged upward through the large tank 1.

[0037] Figure 7 relates to situations where it is necessary to cool both the brain and the spinal cord simultaneously. Such cases may include extensive aortic dissection, explosion and concussion trauma, and other exposures to trauma such as radiation exposure. By cooling from the large tank 1, both the brain and the spinal cord can be cooled simultaneously by discharging the cooled aCSF from the head outlet and the lumbar puncture site outlet.

[0038] Prevention of the sharp tip of the needle cutting the brain To prevent the sharp tip of the needle 3 from piercing or tearing the large cistern 1 or other nerve tissues in the brainstem, spinal cord, and brain, the tip of the needle 3 is made of a shape memory alloy and changes its shape when the temperature changes within a predetermined range, as shown in FIG. 11. In addition to removing the sharpness of the needle tip, the shape of the outlet may be changed to maximize the outflow of cooled aCSF while improving the flow pattern that could damage adjacent nerve tissues. Nitinol is an abbreviation for a nickel-titanium alloy developed by the U.S. Navy and is one of the shape-changing alloys with thermal memory.

[0039] FIG. 11 shows the concept of using a temperature-sensitive alloy such as Nitinol at the cutting tip of the needle. After the sharp-tipped needle 21 is inserted into the large cistern 1, the shaft of the needle must be firmly fixed in its determined position. When the cannula is removed and cooled aCSF is administered through the shaft of the needle, the cutting tip changes shape to a blunt tip 22 without a sharp edge. When the pump is rapidly increased to a higher volume, it is important to design a new shape at the end of the needle shaft so that the aCSF disperses gently as it enters the large cistern 1. For this, a flared tip 23 or other shape determined by computer simulation and modeling may be required.

[0040] When using a needle 3 similarly designed to quickly enter large blood vessels such as the femoral artery, while the paramedic uses a handheld video and acoustic unit as shown in FIG. 9 to quickly guide the tip and the needle 3 into the blood vessel, the phased array cannula 19 within the tip of the needle 3 depicts various tissues until the needle 3 enters the artery. FIG. 15 shows the target site of the femoral artery 28 and various tissues and blood vessels that may cause confusion during insertion. The semi-autonomous unit 26 is fixed to the anatomical structure that provides stability and fixation for the insertion of the needle into the femoral artery 28. If there is confusion regarding the distinction between arteries and veins, the Doppler signal indicates the difference. When the needle tip 3 enters the artery and needs to be positioned there for a long time, as suggested in FIG. 11, the temperature-sensitive alloy tip 3 changes shape at the higher temperature of arterial blood, dulls the sharp surface, and prevents damage to the artery. The phased array cannula 16 extends up the aorta to identify the circulation of the surrounding abdominal tissues to structures such as the kidneys, spleen, pancreas, liver, heart, and other organs, as shown in FIG. 16. The phased array element has a 30-degree field of view, can penetrate up to 2.5 cm forward, and provides real-time 3D imaging, as shown in FIG. 10. FIG. 16 shows the trajectory of the phased array ultrasound cannula when entering the aorta from the femoral artery 28. The cannula has a 30-degree field of view that provides a three-dimensional real-time image of the blood vessel branches from the aorta and a penetration of up to 2.5 cm. In the case of life-threatening bleeding, aortic balloon tamponade 29 is performed more accurately and quickly.

[0041] Figure 10 shows the effective three-dimensional space in front of 64 or more elements within a 2 mm inner diameter cannula configured to perform phased array imaging. The ultrasonic data can cover a 30-degree field of view and a maximum penetration depth of 2.5 cm 20. The use of phased arrays using multiple ultrasonic elements is utilized throughout the medical industry. Volcano Corporation Systems images with a catheter ultrasonic system have Angio+(trademark) quantitative coronary analysis that automatically calculates lumen dimensions and stenosis in real time. Interson Corporation commercially manufactures a small transducer system with off-the-shelf hardware that uses its own built-in electronics for applications in cardiology.

[0042] Electric insertion of the needle Semi-autonomous or robotic technologies have been commonly practiced for decades and are used in, for example, the navigation of self-driving vehicles. Based on radar, camera data, and GPS information, a "self-driving" vehicle is programmed to use artificial intelligence to safely maneuver the vehicle from home to work. Similarly, we utilize three-dimensional ultrasonic information from the tip of the needle and use artificial intelligence to program a servo motor to guide the needle to safely pass through the skin, fat, muscle, tendon, and blood vessels until it reaches the large tank. Once in the large tank, the needle is automatically fixed in place to prevent damage to nerve tissue. This requires specialized software development that is being done in all other industries. The novelty of the present invention is the application of custom-developed software to insert the needle semi-autonomously or robotically with an accuracy several orders of magnitude higher than that of a self-driving vehicle, i.e., on the order of a fraction of a millimeter within the target site.

[0043] As disclosed in Mathiassen et.al. “Visual Servoing of a Medical Ultrasound Probe for Needle Insertion,” 2016 IEEE International Conference on Robotics and Automation (May 16 - 21, 2016), percutaneous needle insertion guided by ultrasound images is routinely performed in hospitals. Automating these procedures improves the accuracy of placement and reduces the time spent by healthcare providers performing them. An important step in automation is the estimation of the orientation and position of the needle within the ultrasound image. One approach to estimating the orientation and position of the needle is to align the needle with the image plane of the ultrasound probe. Even with accurate measurement and calibration of both the needle and the probe, it is difficult to align the needle with the plane. To align the image plane of the probe with the needle, visual servoing is performed using a robot to move the ultrasound probe, which solves the problem of aligning the needle. In this method, the needle is segmented and a set of visual features is updated based on the model of the needle. A state machine is used to track the alignment process and the probe is controlled in various states using various visual features.

[0044] In this field, there are methods, algorithms, and devices that use images collected from cameras to guide the steering, braking, and acceleration of vehicles. For example, see U.S. Patent Application No. 15 / 413568, "Autonomous Driving Control Device," and U.S. Patent No. 9566983, "Control Arrangement Arranged To Control An Autonomous Vehicle, Autonomous Drive Arrangement, Vehicle And Method," both of which are incorporated herein by reference. In our technology, instead of using images from cameras, we use images from our ultrasonic probes. Instead of controlling the movement of the vehicle, we control the movement of the probe. Overall, the concepts and approaches are similar. The algorithms are different to accommodate the use of different types of images and the control of different types of operating mechanisms. The means for making these adjustments are within the scope of ordinary skill in the art. There are numerous patents issued regarding the use of ultrasonic images as feedback for controlling medical devices. In particular, U.S. Patent No. 8343050, "Feedback in Medical Ultrasound Imaging for High Intensity Focused Ultrasound," incorporated herein by reference, describes the use of ultrasonic imaging to detect and monitor small changes in tissue as a result of irradiating tumor tissue with high-intensity focused ultrasound (HIFU). The images are used as feedback to control the focus, intensity, and duration of the HIFU. In our case, we use the same ultrasonic imaging technology as feedback for controlling the movement of the probe. The algorithm is adapted to control a servo motor instead of HIFU. The basic principles and approaches are the same.

[0045] An electric inserter for the needle 3 to enter the large tank 1 requires a microcontroller 38 with artificial intelligence for controlling the servo motor 39. The servo motor 39 is a rotary actuator or a linear actuator that can accurately control the angle or linear position, speed, and acceleration. This consists of a suitable motor coupled to a sensor for position feedback, as shown in FIG. 14. FIG. 14 shows a system 26 for semi-autonomously or robotically inserting the needle 3 with a phased array ultrasonic cannula having a microcontroller 38 and an ultrasonic data feedback unit 37 for the servo motor 39 instructed by the microcontroller. When a medical expert sets the trajectory of the needle 3 towards the target large tank 1, the ultrasonic data feedback unit 37 instructs the servo motor 39 to insert the needle 3 in real time. The needle 3 is firmly attached to a fixing device on a site such as a "skull cap" in the form of an exoskeleton 24 as shown in FIGS. 12 and 13, or a similar device, and depends on the information from the ultrasonic data feedback unit 37 obtained from the phased array ultrasonic system 16 as shown in FIGS. 9 and 10. The servo motor inserter 26 facilitates the rapid, accurate, and safe insertion of the needle 3 into the large tank 1 in case of emergency. FIG. 9 shows a device used to guide the needle from the skin to the large tank 1 using known techniques with a unique adaptation at the tip of the needle. By using a 2 mm diameter cannula within the cutting needle (17-gauge needle) 16, a phased array ultrasonic imaging field 20 is created using more than 64 ultrasonic elements 19 as shown in FIG. 10. By using raster graphics, a three-dimensional image is presented in real time on the handheld portable monitor 18. The interface unit 17 converts the ultrasonic data into imaging information to be displayed. Both the visual and auditory feedback provided by the monitor 18 assist in the insertion of the needle into the large tank 1. Further, the shape of the large tank 1 may be depicted to enhance the ease and accuracy of insertion. As will be described in more detail below with respect to FIGS. 12 and 13, when the needle 3 is fixed to a stationary site, the cannula 16 is removed from the large tank 1, enabling the administration of cooled aCSF.In the situation of inserting a phased array needle into the femoral artery, the cannula 16 may be introduced into the aorta in order to visualize many vascular branches within the aorta.

[0046] Figure 22 shows a method of treating solid tumors in other parts of the body such as the breast using the exoskeleton 36. From laser scan data or other image data such as MRI or CT scans, a three-dimensional print of a rigid exoskeleton can be quickly created to fit snugly and accurately at the entry or surgical site with minimal movement. This provides a strong structure for fixing the trephine unit 33 and / or the ultrasonic needle 3, and for performing diagnosis and treatment with ultrasonic energy while accurately monitoring the effects on the tumor and surrounding normal tissue, and for accurately targeting the tumor 34 within 1 mm of the tumor 34 in order to administer a therapeutic agent to the tumor 34.

[0047] Figure 23 shows the use of the exoskeleton 36 of Figure 22 firmly fixed to the breast to provide stability and accuracy. Thereafter, the ultrasonic needle 3 is accurately guided to within 1 mm of the tumor 34 in order to diagnose the tissue without damaging the surrounding normal tissue and to accurately treat the tumor 34.

[0048] When inserting the needle 3 into the femoral artery, the phased array ultrasonic system provides anatomical information to facilitate the identification of the femoral artery as distinct from the femoral vein. Also, when the pulse of the femoral artery cannot be felt, the anatomical information from the ultrasonic system more accurately locates the position of the femoral artery. The semi-autonomous ultrasonic needle unit 14 inserted into the femoral artery also requires fixation of the unit as shown in Figure 15, in which case fixation to the inguinal ligament and / or the bony ridge in the exoskeleton configuration is required.

[0049] Methods and devices for safely and rapidly inserting a trephine through the skull To create an exit point for the coolant to exit the subarachnoid space 2 during the washing of the brain with aCSF on the forehead, a medical practitioner needs to perform a safe, rapid, bloodless, and highly accurate trephination of the skull bone. The unit must be self - contained and include a transducer and a semi - autonomous or robotic electric insertion device as described in the "Needle Insertion Method" 26, which is mounted within a "box" attached to the frontal bone region. The "screw" 30 includes a hollow shaft within a screw with an inner diameter of 3 - 4 mm and equipped with a trocar 31 that is carefully screwed into the skull. The information received from the transducer within the device 26 controls the safe insertion of the screw 30 through the bone into the subarachnoid space 2 by a semi - autonomous or robot. Figure 17 shows a hollow trephine screw 30 with a central trocar 31. When the central trocar 31 is removed, a conical tunnel 32 remains for a safe, accurate, and well - fixed tight placement into the subarachnoid space 2. When placed in the predetermined position, this trephine screw 30 enables the removal of cerebrospinal fluid from the subarachnoid space.

[0050] The insertion method of the semi - autonomous trephine unit usually selects an entry point, which is usually in the upper frontal region near the hairline, and then, along the crease line in the natural skin fold, is incised with a scalpel from the skin down to the subcutaneous tissue covering the frontal bone. Sterility is maintained, an anesthetic containing a vasoconstrictor is injected into the skin, and the incision length is 1.0 - 1.5 mm. A self - retaining retractor is inserted into the wound for stability and hemostasis. The box unit 26 and the screw 30 are inserted into this opening and fixed to the retractor. The semi - autonomous or robotic insertion is activated and carefully guided through the bone into the subarachnoid space 2. Ultrasonic data is obtained from four or more transducers 40 within the trephine "box" attached to the scalp. A microcontroller 38 with artificial intelligence instructs a servomotor 39, and the servomotor 39 screws the trephine into the skull bone. The final configuration is very stable and is movable by the screw within the frontal bone as shown in Figure 18.

[0051] The screw 30 inside the frontal bone is firmly attached, very stable, and well-fixed. As shown in Figure 13, this functions as one point to which the headband is attached, and the headband is carried to the back of the head and attached to two or three points at the back, enhancing stability when inserting the ultrasonic needle into the large tank.

[0052] At the end of the procedure, removal of the screw 30 can be performed using local anesthesia, bone wax placed in the small 3 - 4 mm opening if necessary, and a single suture placed over the skin. Since the incision is made along the wrinkle line, the scar is minimized and the incision is located within the natural skin fold.

[0053] Furthermore, due to the central role in cooling the brain by creating an exit port, the disclosed methods and devices can be used in other brain surgeries including epidural hematoma surgery, subdural hematoma surgery, and stereotactic intracranial surgery.

[0054] Accordingly, an approach combining the ultrasonic needle 3 and the trephine 33 for the treatment of intracranial brain tumors, particularly glioblastoma, is presented here. Figure 18 shows a trephine device unit 33 that houses four or more transducers. These transducers provide ultrasonic information to a servo motor with semi-autonomous or robotic control to guide the screw through the skull and firmly fix it to the bone, and then stop the screw when it enters the subarachnoid space 2.

[0055] New approach to the diagnosis, localization, and management of glioblastoma: Glioblastoma, the most common primary brain tumor, resists early diagnosis and treatment. From diagnosis by conventional imaging and brain biopsy to inevitable death within 4 to 16 months of patients, these patients frequently undergo neurosurgical operations, radiotherapy, and chemotherapy with little hope of cure. We have the technology and expertise to achieve disease characterization and diagnosis, in some cases, without performing a formal biopsy of the tissue by analyzing tissue characteristics from data using ultrasound examinations. The disclosed approach is to minimally invasively insert an ultrasound needle into the skull and subarachnoid space to scan the brain with a 30-degree field of view and a maximum depth of 2.5 cm. The ultrasound data from the tip of the needle is used to image the tumor in three dimensions and to insert the tip of the needle within 1 mm of the target tissue semi-autonomously or by a robot. This requires the accuracy and development of a servo control device to pierce the skull 33 and guide the ultrasound needle 3 to the target tissue.

[0056] The current state-of-the-art in brain ultrasonic imaging is to use a transducer on the scalp and transmit energy through the bony skull. Low-frequency transducers have the advantage of being transmitted through the scalp and bone tissue, but have low resolution. To perform high-resolution imaging at the cellular and / or tissue level, it is necessary for the ultrasonic transducer to be close to the object and to have high-frequency imaging. This poses a dilemma. Therefore, an ideal ultrasonic design would have a non-invasive device that uses a high-frequency transducer to penetrate the diseased site. This can be achieved by making the opening of the trephine 33 through the bony skull small enough to be minimally invasive and using an ultrasonic unit designed to be placed within the contour of the needle 3. Further, the ultrasonic needle 3 is accurately inserted into the body's soft tissue using a semi-autonomous or robotic electric system. Recent basic experimental studies by Sheehan et al. have reported a positive effect of the use of ultrasonic radiation to enhance the effect of drugs on the death of cultured glioblastoma cells (Kimball Sheehan et al. Investigation of tumoricidal effects of sonodynamic therapy in malignant glioblastoma brain tumors. J. Neuro-Oncology. 148, 9-16, 2020).

[0057] The above discloses the use of the ultrasonic needle 26 and the semi-autonomous or robotic trephine 33, which are used beyond the original purpose of cooling the brain in the case of brain death. The basis of this approach is that, since the elements within the tip of the needle 3 used for imaging are utilized, the sound is programmed to generate energy from the same transducer within the tip of the same needle 3. This method for treating glioblastoma of the brain relies on the close relationship between the semi-autonomous or robotic ultrasonic needle 26 and the semi-autonomous or robotic trephine 33, which are combined to form a unique, accurate, and stable platform. The design and characteristics of the ultrasonic needle 26 and the trephine 33 are as described above. The application of this technology gives rise to a new approach to the diagnosis, localization, and management of glioblastoma of the brain.

[0058] Furthermore, the ultrasonic needle includes at least 64 elements within a 2 mm diameter cannula within the tip of the needle, having a fineness of less than 0.1 mm, a 30-degree field of view, and a maximum depth of 2.5 cm. The ultrasonic needle can not only image the shape and size of the tumor but also render specific tissue characteristics when ultrasound is passed near or within the tumor and through normal tissue. Thus, tissue diagnosis can be performed with ultrasound alone. After the semi-autonomous or robotic insertion of the hollow screw 30 is performed down to the level of the subarachnoid space 2, the trocar 31 of the screw 30 is removed and replaced with the ultrasonic needle 3 surrounded by its own semi-autonomous or robotic unit 26. These two units function integrally and are firmly attached, providing very good accuracy and fixation while the needle 26 is being sent deeper into the cranial cavity. FIG. 19 shows the use of the device of FIG. 10, namely the ultrasonic needle 3 including a 2 mm inner diameter needle 3 with more than 64 ultrasonic elements for characterizing the tissue of the tumor relative to the surrounding normal tissue. The ultrasonic elements provide information for guiding the semi-autonomous or robotic insertion device 26 of the needle 3 into the semi-autonomous or robotic trephine 33 for imaging, and for treating the glioblastoma tumor 34. The ultrasonic transducer generates energy at the tip of the needle 3 near the tumor 34. After pre-treatment of the tumor 34, the same needle 3 enables the administration of various treatment methods in microliter units. Following the administration of the drug, the ultrasonic needle 3 can then image the tissue to determine the location of the treatment effect.

[0059] Ultrasound (US)-guided biopsy is a medical procedure routinely performed in clinical practice. This task can be performed by a robotic system in order to improve the accuracy of execution and to improve patient safety. Both robotic and human procedures benefit greatly from real-time localization of the needle within the US image. This information guides the robot or the expert to the correct target point while avoiding important structures. Mathiassen et.al. “Real Time Biopsy Needle Tip Estimation in 2D Ultrasound Images,” 2013 IEEE International Conference on Robotics and Automation (May 6-10, 2013) discloses a method for needle position determination that can extract the needle orientation and tip position in real time from B-mode US images. The results show an improvement in terms of localization accuracy compared to past studies in the literature.

[0060] As disclosed in Mathiassen, “Robust Real-Time Needle Tracking in 2-D Ultrasound Images Using Statistical Filtering”, IEEE Transactions on Control Systems Technology, 2017, 25(3) 966-978, percutaneous image-guided tumor resection is a minimally invasive surgical procedure for the treatment of malignant tumors using a needle-shaped ablation probe. By automating needle insertion using a robot, the accuracy is improved and the execution time of the procedure is shortened. By extracting the position of the needle tip from an ultrasonic (US) image, it is confirmed that the needle is not approaching prohibited regions (e.g., major blood vessels and ribs), and it is also used as a direct feedback signal to the robot inserting the needle. Methods for estimating the needle tip have been developed in the past that combine the modified Hough transform, image filters, and machine learning. Also known is a method that introduces dynamic selection of the region of interest in the US image and filters the tracking results using either a Kalman filter or a particle filter. The results show a significant improvement in accuracy compared to past automatic approaches, with a reduction in the 95th percentile of errors exceeding 85%. This method is executed in real time at a frame rate of 35.4 frames / second. For improved robustness and accuracy, the disclosed algorithm can be used in autonomous or robotic surgical systems for needle insertion.

[0061] FIG. 20 is an enlarged view of a part of FIG. 19 showing the insertion site, and shows a combination of the devices of FIGS. 17 and 19 including the trephine unit 33 and the ultrasonic needle unit 26. The ultrasonic needle 3 is carefully guided into the subarachnoid space 2 and fixed at a predetermined position for tissue diagnosis, for mapping the brain tissue, and for creating a trajectory of the ultrasonic needle 3 into the brain.

[0062] Figure 21 shows how this design enables the precise directional guidance of the ultrasonic needle 3 to the target in the glioblastoma tumor 34. The ultrasonic needle 3 has a diameter of 2 mm and fits into a 3 - 4 mm hollow conical space within the stabilizing screw 30 that surrounds it, so the placement of the ultrasonic needle 3 using the semi - autonomous or robotic system 26 is performed with high precision.

[0063] Since the hollow core within the screw 30 is conical, there is play for the 2 - mm - diameter needle within the 3 - 4 mm hollow screw trephine. Thus, with control by a semi - autonomous or robotic motor, the needle 3 can expand its range and cover an area wider than 30°. By imaging the tissue immediately in front of the ultrasonic needle to a depth of up to 2.5 cm, the shape and size of the tumor are depicted. Furthermore, since the tissue density can be measured by ultrasound, glioblastoma cells can be diagnosed from normal tissue. To confirm the ultrasound diagnosis, a needle biopsy may be performed through the needle 3 for verification.

[0064] If it is determined to guide the needle 3 deeper into the brain tissue using semi - autonomous or robotic control and ultrasonic information, the needle 3 can be slowly and precisely placed up to the boundary of the tumor 34 or, in some cases, within the tumor 34. Subsequently, the transducer can be programmed to generate ultrasonic energy within the tumor 34, in front of the tip 3 of the needle. Through the tip 3 of the needle, chemotherapeutic agents, immunotherapy, or other modalities can be added in well - controlled small amounts in microliter units. The effect of the injection into the tissue can be confirmed by using ultrasonic imaging to look for abnormal tissue reactions. An intracranial pressure gauge (not shown) indicates whether there is swelling of the tissue that causes an increase in intracranial pressure. If necessary, hypothermia treatment of the brain may be applied to prevent swelling by cooling the brain.

[0065] Semi - autonomous or robotic insertion of the ultrasonic needle: Semi-autonomous or robotic insertion of the needle into the large groove is achieved by using a servo-controlled motor guided by information obtained from 64 elements within the tip of the needle 3. The information has a three-dimensional space with a range of 30 degrees and a maximum depth of 2.5 cm, as shown in FIG. 10. An artificial intelligence with a self-learning algorithm provides machine learning to the microcontroller 38 of the device 26 in FIG. 14. The semi-autonomous or robotic insertion and the realization of the servo-controlled motor are described in "Electric insertion of the needle".

[0066] Semi-autonomous or robotic insertion of nedotrephin: Semi-autonomous or robotic insertion of nedotrephin 33 through the skull into the subarachnoid space is performed using a servo-controlled motor (not shown) guided by information obtained from four or more transducers within the unit 26 placed on the scalp. In FIG. 18, the information includes ultrasonic data on the bone thickness and the boundaries between the dura mater and the arachnoid mater and the subarachnoid space 2 containing cerebrospinal fluid. When the controller confirms the appropriate boundary for the hollow bore screw 30 with the trocar 21, the fixation of the screw 30 into the bone is automatically completed. The semi-autonomous or robotic insertion and the realization of the servo-controlled motor are described in "Electric insertion of the needle".

[0067] Without departing from the spirit and scope of the embodiments, many changes and modifications can be made by those skilled in the art. Therefore, it should be understood that the illustrated embodiments are shown for illustrative purposes only and should not be construed as limiting the embodiments defined by the following embodiments and their various embodiments.

[0068] Accordingly, it should be understood that the illustrated embodiments are shown for purposes of example only and should not be construed as limiting the embodiments defined by the following claims. For example, even if an element of a claim is described below in a particular combination, the embodiments are clearly understood to include other combinations of fewer, more, or different elements as disclosed above, even if such combinations were not originally claimed. The teaching that two elements are combined in a claimed combination should further be understood to allow for the claimed combination in which the two elements are not combined with each other and are used alone or in other combinations. The deletion of any disclosed element of an embodiment is clearly contemplated as being within the scope of the embodiment.

[0069] The words used herein to describe various embodiments are to be understood not only in the sense of their generally defined meanings, but also as including by special definition herein, structures, materials, or acts that exceed the scope of their generally defined meanings. Accordingly, in the context of this specification, if an element can be understood to include more than one meaning, its use in a claim should be understood to be inclusive of all possible meanings supported by the specification and the word itself.

[0070] Accordingly, the definitions of the words or elements in the following claims are defined herein as including not only the literal combinations of the recited elements, but also all equivalent structures, materials, or acts for performing substantially the same function in substantially the same way to obtain substantially the same result. Accordingly, in this sense, it is contemplated that any one of the elements within the following claims may be equivalently replaced by two or more elements, or a single element may replace two or more elements within the claim. An element may be described above as acting in a particular combination and may even have been originally claimed as such, but in some cases, one or more elements from the claimed combination may be deleted from the combination, and the claimed combination may be directed to a sub-combination or a variation of a sub-combination.

[0071] From the perspective of one of ordinary skill in the art, changes that are not substantial to the claimed subject matter are clearly contemplated to be within the scope of the claims equally, whether now known or later devised. Accordingly, obvious substitutions now known or later known to one of ordinary skill in the art are defined to be within the scope of the defined elements.

[0072] Accordingly, the claims are to be understood as including what is specifically illustrated and described above, what is conceptually equivalent, what can be obviously substituted, and what essentially incorporates the essential ideas of the embodiments.

Claims

1. A method of preventing brain death by rapidly and safely cooling the brain, wherein the brain has a large cavity accessible through the patient's neck, using a specially designed needle / cannula that allows for the flow of cooled artificial cerebrospinal fluid (aCSF) around the brain, and introducing aCSF cooled to 1-10 °C into the large cavity through an inlet via the patient's neck, so as to circulate the aCSF around the cavities within the brain and within the subarachnoid space surrounding the brain, exiting the aCSF through an opening in the skull where a temperature / pressure sensor is disposed, transmitting data to a computer-controlled electric system that pumps the cooled aCSF into the needle / cannula disposed within the large cavity, controlling the pumping of the aCSF to maintain a predetermined temperature and / or pressure of the exiting aCSF, the method comprising.

2. further comprising collecting the exiting aCSF into a sterile container below the patient without recycling, the method according to claim 1.

3. further comprising recycling the exiting aCSF through a filtration and cooling system, and pumping the recycled aCSF by the computer-controlled electric system into the needle / cannula disposed within the large cavity, the method according to claim 1.

4. A method for rapidly and safely cooling a patient's spinal cord to protect it from trauma or ischemia, providing a source of cooled and pressurized artificial cerebrospinal fluid (aCSF), using a specially designed needle / cannula and inserting the cooled aCSF through an inlet via the patient's neck into a large cavity at the base of the patient's brain, flowing the cooled and pressurized aCSF into the spinal canal, exiting the aCSF through a lumbar puncture needle, the method comprising.

5. A method for rapidly and safely cooling a patient's spinal cord to protect it from trauma or ischemia, providing a source of cooled and pressurized artificial cerebrospinal fluid (aCSF), inserting the cooled aCSF through a lumbar puncture needle, flowing the cooled and pressurized aCSF into the spinal canal, using a specially designed needle / cannula and exiting the aCSF from a large cavity at the base of the patient's brain through an outlet via the patient's neck, the method comprising. **Claim 6** The method according to claim 1, further comprising performing a procedure in neurosurgery, radiotherapy, stereotactic surgery, vascular surgery, ultrasonic intervention, high-energy proton beam therapy, or other invasive or non-invasive therapies. The method according to claim 1. **Claim 7** The method according to claim 1, further comprising inserting a sensor into the subarachnoid space of the brain and using the sensor inserted into the subarachnoid space to monitor the chemical properties of the brain. The method according to claim 1. **Claim 8** The method according to claim 1, further comprising positioning the opening within the skull from which the aCSF exits on the frontal side of the skull, placing the patient supine, and establishing convective cooling by creating a difference between the cooler fluid within the posterior cranial region brain closer to the cistern and the warmer fluid rising towards the forehead, thereby promoting the flow of the aCSF within the brain to make the outflow of the aCSF from the skull more efficient and rapid, and making the cooling effect more rapid. The method according to claim 1. **Claim 9** A needle having a tip for puncturing a patient's skin, a phased array of ultrasonic elements for generating ultrasonic images, the phased array being disposed at the tip of the needle, an ultrasonic imaging system within a lightweight handheld monitor having an acoustic function that communicates with the phased array within the tip of the needle, the ultrasonic imaging system generating images of all tissues from the skin surface down to a target tissue below, with a field of view of at least 30 degrees or more and a penetration of up to 2.5 cm or more. An apparatus. **Claim 10** The tip of the needle has a sharp cutting shape for entering the patient's cistern, the tip of the needle is composed of a shape memory alloy, and in response to a temperature change when cooled aCSF enters the needle, it changes shape to a blunt blade and a blunt tip to avoid damage to the brain tissue adjacent to the cistern. The apparatus according to claim 9. **Claim 11** The tip of the needle has a sharp cutting shape, the tip of the needle is composed of a shape memory alloy, and in response to a temperature change when cooled aCSF enters the needle, it changes shape to a shape that allows for a gentle dispersion of the aCSF instead of a strong and directed fluid flow that could damage the cistern and the adjacent brain tissue. The device according to claim 10.

12. A semi-autonomous unit having a microcontroller with artificial intelligence, and a servo-controlled electric inserter that communicates with the ultrasonic imaging system to guide the needle into the large tank using ultrasonic image data from the phased array element within the tip of the needle. The device according to claim 9, further comprising:

13. Further comprising a cannula disposed within the tip of the needle, wherein the phased array of the ultrasonic elements is disposed within the cannula, and the device communicates with the ultrasonic imaging system to accurately and rapidly place the needle within the femoral artery of a patient. The device further comprises a semi-autonomous or robotic unit that guides the phased array cannula into the arterial circulation of the femoral artery, and the cannula is available for assisting in selective balloon tamponade of the aorta or its branches. The device according to claim 9.

14. A trephine unit comprising a hollow screw that functions as a conduit from outside the patient's head to the subarachnoid space within the skull, the hollow screw including a central trocar having a cutting tip that defines a conical space within the hollow screw when removed. Device.

15. By fixing the hollow screw in a stationary position relative to the patient's head, the relative position of the conduit is accurately and stably fixed. The device according to claim 14.

16. Further comprising a band behind the patient's head, and when selecting two or more posterior points to provide stability to the needle when inserted into the patient's large tank, the screw is a fixed point of the band. The device according to claim 14.

17. Further comprising an ultrasonic-guided semi-autonomous or robotic trephine unit combined with the ultrasonic imaging system, the ultrasonic-guided semi-autonomous or robotic trephine unit being used to enable the needle to enter the patient's subarachnoid space safely and rapidly through an incision in the patient's skin and a perforation formed in the skull. The device according to claim 14.

18. The phased array of the ultrasonic elements generates energy for therapeutic mediation of tissue, and the ultrasonic imaging system identifies specific tissue characteristics of a solid tumor with respect to normal tissue located at other locations in the patient's body. The device according to claim 9.

19. A disposable exoskeleton on the surgical site of the patient's body, and an ultrasonic guide semi-autonomous trephine unit used to accurately and stably fix the needle to the exoskeleton at the surgical site when guiding the penetration of the needle. The apparatus according to claim 9.

20. To accurately and stably fix the trephine unit and / or the needle unit, the shape of the exoskeleton is defined using a three-dimensional surface scan of the surgical site, and the exoskeleton fits tightly and accurately to the surgical site with minimal movement relative to the surgical site, for diagnosing and treating the tumor with ultrasonic energy, for administering a therapeutic agent to the tumor, and / or for monitoring the effect of the therapeutic agent on the tumor and surrounding normal tissue, enabling accurate targeting and penetration of the tumor to within 1 mm. The apparatus according to claim 19.

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